CHEST Physician

Testing COVID-19 vaccines in young children is going to be tricky. Deciding how to approve them and who should get them may be even more difficult.

So far, the vaccines available to Americans ages 12 and up have sailed through the U.S. Food and Drug Administration’s regulatory checks, taking advantage of an accelerated clearance process called an Emergency Use Authorization (EUA). 

EUAs set a lower bar for effectiveness, saying the vaccines may be safe and effective based on just a few months of data. 

But with COVID cases plummeting in the United States and children historically seeing far less serious disease than adults, a panel of expert advisors to the FDA was asked to deliberate on Thursday whether the agency could consider vaccines for this age group under the same standard. 

Stated another way: Is COVID an emergency for kids? 

There’s another wrinkle in the mix, too – heart inflammation, which appears to be a very rare emerging adverse event tied to vaccination. It seems to happen more often in teens and young adults. To date, cases of myocarditis and pericarditis appear to be happening in 16 to 30 people for every 1 million doses given. 

But if it is conclusively linked to the shots, some wonder whether it might tip the balance between benefits and risks for kids.

That left some of the experts who sit on the FDA’s advisory committee for vaccines and related biological products urging the FDA to take its time and more thoroughly study the shots before they’re given to millions of children.
 

Vaccine studies different in children?

Clinical studies of the vaccines in teens and adults have thus far relied on some straightforward math. You take two groups of similar people. You give half the vaccine and half a placebo. Then you wait and see which group has more symptomatic infections. To date, the vaccines have dramatically cut the risk of getting severely ill with COVID for every age group tested.

But COVID infections are falling rapidly in the U.S., and that may make it more difficult for researchers to conduct a similar kind of experiment in children.

The FDA is considering different approaches to figure out whether a vaccine would be effective in kids, including something called an “immunobridging trial.” 

In bridging trials, researchers don’t look for infections; rather, they look for proven signs that someone has developed immunity, like antibody levels. Those biomarkers are then compared to the immune responses of younger adults who have demonstrated good protection against infection.

The main advantage of bridging studies is speed. It’s possible to get a snapshot of how the immune system responds to a vaccine within weeks of the final dose.

The drawback is that researchers don’t know exactly what to look for to judge how well the shots are generating protection. 

That’s made even more difficult because kids’ immune systems are still developing, so it may be tough to draw direct parallels to adults.

“We don’t know what the serologic correlate of immunity is now. We don’t know how much antibody you have to get in order to be protected. We don’t know what the role of T cells will be,” said H. Cody Meissner, MD, chief of the division of pediatric infectious disease at Tufts Medical Center, Boston.

“I have so much sympathy for the FDA because these are enormous problems, and you have to make a decision,” said Dr. Meissner, who is a member of the FDA’s vaccines and related biological products advisory committee.
 

Speed vaccines to market, or gather more data?

The plummeting rate of infections in the United States also means that it may be more difficult for the FDA to justify allowing a vaccine on the market for emergency use for children under age 12.

In its recent advisory committee meeting, the agency asked the panel whether it should consider COVID vaccines for children under an EUA or a biologics license application (BLA), aka full approval. 

A BLA typically means the agency considers a year or two of data on a new product, rather than just 2 months’ worth. Emergency use also allows products on the market under a looser standard – they “may be” safe and effective, instead of has been proven to be safe and effective.

Several committee members said they didn’t feel the United States was still in an emergency with COVID and couldn’t see the FDA allowing a vaccine to be used in kids that wasn’t given the agency’s highest level of scrutiny, particularly with reports of adverse events like myocarditis coming to light.

“I just want to be sure the price we pay for vaccinating millions of children justifies the side effects, and I don’t think we know that yet,” Dr. Meissner said.

Others acknowledged that there was little risk to kids now with infections on the decline but said that picture could change as variants spread, schools reopen, and colder temperatures force people indoors. 

The FDA must decide whether to act based on where we are now or where we could be in a few months.

“I think it’s the million-dollar question right now,” said Hannah Kirking, MD, a medical epidemiologist with the Centers for Disease Control and Prevention who presented new and unpublished data on COVID’s impact in children to the FDA’s advisory committee.

She said prospective studies tracking the way COVID moves through a household with weekly testing from New York City and Utah had found that children catch and transmit COVID almost as readily as adults. But they don’t usually get as sick as adults do, so their cases are easy to miss. 

She also presented the results of blood tests from samples around the country looking for evidence of past infection. In these seroprevalence studies, about 27% of children under age 17 had antibodies to COVID – the most of any age group. So more than 1 in 4 kids already has some natural immunity.

That means the main benefit of vaccinating children might be the protection of others, while they still bear the risks – however tiny.

Some experts felt that wasn’t enough reason to justify mass distribution of the vaccines to kids, and from a regulatory standpoint, it might not be permissible.

“FDA can only approve a medical product in a population if the benefits outweigh the risks in that population,” said Peter Doshi, PhD, assistant professor of pharmaceutical health services research in the University of Maryland’s school of pharmacy, Baltimore.

“If benefits don’t outweigh risks in children, it can’t be indicated for children. Full stop,” said Dr. Doshi, who is also an editor at the BMJ.

He said there’s another way to give children access to vaccines, through an expanded access or compassionate use program. Because most COVID deaths have been in children with underlying health conditions, Dr. Doshi and others said it might make sense to allow expanded access – which would get vaccines to children at high risk for complications – without turning them loose on millions before they are more thoroughly studied.

“It’s not a particularly attractive option for industry, because there’s no money to be made. Your medicine can’t be commercialized under expanded access. The most you can reap is manufacturing cost, which is not a lot,” he said.

Art Caplan, a professor of bioethics at New York University’s Langone medical center, said the argument for vaccinating children for flu falls along the same lines. The benefit-to-risk ratio is finely balanced in children.  The main value of protecting them is to protect others.

“Flu rarely kills young folks. But you’re really trying to protect old folks and that’s the classic example,” he said.

What’s more, he said the idea that children would take on some risk with a vaccine for little personal benefit is oversimplified.

“Yes, you might get vaccinated to prevent harm to others, but those others are providing benefits to you. It’s not a one-way street. I think that’s a little morally distorted,” Mr. Caplan said. “Being able to keep society open benefits kids and adults alike.”

Other committee members felt like it was too early to sound the all-clear on COVID and said the FDA should authorize vaccines for children as quickly as it had for other age groups.

“We are still, I believe, in an emergency situation. I think that when this virus goes into our children, which is what it’s going to do, that will give it an incubator to change,” said Oveta Fuller, PhD, associate professor of microbiology and immunology at the University of Michigan, Ann Arbor.

Fuller said that for the good of the world, Americans needed to vaccinate children to prevent the virus from mutating and creating new and potentially more dangerous variants.
 

Weighing risk over safety

Beth Thielen, MD, PhD, pediatric infectious disease specialist and virologist at the University of Minnesota, Minneapolis, said she had not followed the committee’s discussions, but about once a month she treats kids who are very sick because of the virus – either because of a COVID infection or because of multisystem inflammatory syndrome (MIS-C), an inflammatory reaction that strikes after infection.

She’s worried about how the virus has already changed. She said the kind of disease she’s seeing in kids now is different than what she saw in the early months of the pandemic.

“In the last couple of months, I’ve actually seen a few cases of severe pulmonary disease, more similar to adult disease in children,” Dr. Thielen said. “I see on the horizon that we could start seeing more significant disease in young people, and then the risks of being unvaccinated go up substantially.” 

But she also knows nobody has a crystal ball, and right now, everything seems to be trending in the right direction with COVID. That makes the risk-to-benefit consideration murkier.

“The question in my mind is, what is the risk of side effects from the vaccine?” she said. “I think we really need to know what the safety profile of vaccine looks like in children because we do have a decent understanding now what risk from disease looks like, because it’s small, but we are seeing it.”

Dr. Thielen said she’ll be keeping an eye on the next meeting of the CDC’s Advisory Committee on Immunization Practices for more answers.

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

Testing COVID-19 vaccines in young children is going to be tricky. Deciding how to approve them and who should get them may be even more difficult.

So far, the vaccines available to Americans ages 12 and up have sailed through the U.S. Food and Drug Administration’s regulatory checks, taking advantage of an accelerated clearance process called an Emergency Use Authorization (EUA). 

EUAs set a lower bar for effectiveness, saying the vaccines may be safe and effective based on just a few months of data. 

But with COVID cases plummeting in the United States and children historically seeing far less serious disease than adults, a panel of expert advisors to the FDA was asked to deliberate on Thursday whether the agency could consider vaccines for this age group under the same standard. 

Stated another way: Is COVID an emergency for kids? 

There’s another wrinkle in the mix, too – heart inflammation, which appears to be a very rare emerging adverse event tied to vaccination. It seems to happen more often in teens and young adults. To date, cases of myocarditis and pericarditis appear to be happening in 16 to 30 people for every 1 million doses given. 

But if it is conclusively linked to the shots, some wonder whether it might tip the balance between benefits and risks for kids.

That left some of the experts who sit on the FDA’s advisory committee for vaccines and related biological products urging the FDA to take its time and more thoroughly study the shots before they’re given to millions of children.
 

Vaccine studies different in children?

Clinical studies of the vaccines in teens and adults have thus far relied on some straightforward math. You take two groups of similar people. You give half the vaccine and half a placebo. Then you wait and see which group has more symptomatic infections. To date, the vaccines have dramatically cut the risk of getting severely ill with COVID for every age group tested.

But COVID infections are falling rapidly in the U.S., and that may make it more difficult for researchers to conduct a similar kind of experiment in children.

The FDA is considering different approaches to figure out whether a vaccine would be effective in kids, including something called an “immunobridging trial.” 

In bridging trials, researchers don’t look for infections; rather, they look for proven signs that someone has developed immunity, like antibody levels. Those biomarkers are then compared to the immune responses of younger adults who have demonstrated good protection against infection.

The main advantage of bridging studies is speed. It’s possible to get a snapshot of how the immune system responds to a vaccine within weeks of the final dose.

The drawback is that researchers don’t know exactly what to look for to judge how well the shots are generating protection. 

That’s made even more difficult because kids’ immune systems are still developing, so it may be tough to draw direct parallels to adults.

“We don’t know what the serologic correlate of immunity is now. We don’t know how much antibody you have to get in order to be protected. We don’t know what the role of T cells will be,” said H. Cody Meissner, MD, chief of the division of pediatric infectious disease at Tufts Medical Center, Boston.

“I have so much sympathy for the FDA because these are enormous problems, and you have to make a decision,” said Dr. Meissner, who is a member of the FDA’s vaccines and related biological products advisory committee.
 

Speed vaccines to market, or gather more data?

The plummeting rate of infections in the United States also means that it may be more difficult for the FDA to justify allowing a vaccine on the market for emergency use for children under age 12.

In its recent advisory committee meeting, the agency asked the panel whether it should consider COVID vaccines for children under an EUA or a biologics license application (BLA), aka full approval. 

A BLA typically means the agency considers a year or two of data on a new product, rather than just 2 months’ worth. Emergency use also allows products on the market under a looser standard – they “may be” safe and effective, instead of has been proven to be safe and effective.

Several committee members said they didn’t feel the United States was still in an emergency with COVID and couldn’t see the FDA allowing a vaccine to be used in kids that wasn’t given the agency’s highest level of scrutiny, particularly with reports of adverse events like myocarditis coming to light.

“I just want to be sure the price we pay for vaccinating millions of children justifies the side effects, and I don’t think we know that yet,” Dr. Meissner said.

Others acknowledged that there was little risk to kids now with infections on the decline but said that picture could change as variants spread, schools reopen, and colder temperatures force people indoors. 

The FDA must decide whether to act based on where we are now or where we could be in a few months.

“I think it’s the million-dollar question right now,” said Hannah Kirking, MD, a medical epidemiologist with the Centers for Disease Control and Prevention who presented new and unpublished data on COVID’s impact in children to the FDA’s advisory committee.

She said prospective studies tracking the way COVID moves through a household with weekly testing from New York City and Utah had found that children catch and transmit COVID almost as readily as adults. But they don’t usually get as sick as adults do, so their cases are easy to miss. 

She also presented the results of blood tests from samples around the country looking for evidence of past infection. In these seroprevalence studies, about 27% of children under age 17 had antibodies to COVID – the most of any age group. So more than 1 in 4 kids already has some natural immunity.

That means the main benefit of vaccinating children might be the protection of others, while they still bear the risks – however tiny.

Some experts felt that wasn’t enough reason to justify mass distribution of the vaccines to kids, and from a regulatory standpoint, it might not be permissible.

“FDA can only approve a medical product in a population if the benefits outweigh the risks in that population,” said Peter Doshi, PhD, assistant professor of pharmaceutical health services research in the University of Maryland’s school of pharmacy, Baltimore.

“If benefits don’t outweigh risks in children, it can’t be indicated for children. Full stop,” said Dr. Doshi, who is also an editor at the BMJ.

He said there’s another way to give children access to vaccines, through an expanded access or compassionate use program. Because most COVID deaths have been in children with underlying health conditions, Dr. Doshi and others said it might make sense to allow expanded access – which would get vaccines to children at high risk for complications – without turning them loose on millions before they are more thoroughly studied.

“It’s not a particularly attractive option for industry, because there’s no money to be made. Your medicine can’t be commercialized under expanded access. The most you can reap is manufacturing cost, which is not a lot,” he said.

Art Caplan, a professor of bioethics at New York University’s Langone medical center, said the argument for vaccinating children for flu falls along the same lines. The benefit-to-risk ratio is finely balanced in children.  The main value of protecting them is to protect others.

“Flu rarely kills young folks. But you’re really trying to protect old folks and that’s the classic example,” he said.

What’s more, he said the idea that children would take on some risk with a vaccine for little personal benefit is oversimplified.

“Yes, you might get vaccinated to prevent harm to others, but those others are providing benefits to you. It’s not a one-way street. I think that’s a little morally distorted,” Mr. Caplan said. “Being able to keep society open benefits kids and adults alike.”

Other committee members felt like it was too early to sound the all-clear on COVID and said the FDA should authorize vaccines for children as quickly as it had for other age groups.

“We are still, I believe, in an emergency situation. I think that when this virus goes into our children, which is what it’s going to do, that will give it an incubator to change,” said Oveta Fuller, PhD, associate professor of microbiology and immunology at the University of Michigan, Ann Arbor.

Fuller said that for the good of the world, Americans needed to vaccinate children to prevent the virus from mutating and creating new and potentially more dangerous variants.
 

Weighing risk over safety

Beth Thielen, MD, PhD, pediatric infectious disease specialist and virologist at the University of Minnesota, Minneapolis, said she had not followed the committee’s discussions, but about once a month she treats kids who are very sick because of the virus – either because of a COVID infection or because of multisystem inflammatory syndrome (MIS-C), an inflammatory reaction that strikes after infection.

She’s worried about how the virus has already changed. She said the kind of disease she’s seeing in kids now is different than what she saw in the early months of the pandemic.

“In the last couple of months, I’ve actually seen a few cases of severe pulmonary disease, more similar to adult disease in children,” Dr. Thielen said. “I see on the horizon that we could start seeing more significant disease in young people, and then the risks of being unvaccinated go up substantially.” 

But she also knows nobody has a crystal ball, and right now, everything seems to be trending in the right direction with COVID. That makes the risk-to-benefit consideration murkier.

“The question in my mind is, what is the risk of side effects from the vaccine?” she said. “I think we really need to know what the safety profile of vaccine looks like in children because we do have a decent understanding now what risk from disease looks like, because it’s small, but we are seeing it.”

Dr. Thielen said she’ll be keeping an eye on the next meeting of the CDC’s Advisory Committee on Immunization Practices for more answers.

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

Testing COVID-19 vaccines in young children is going to be tricky. Deciding how to approve them and who should get them may be even more difficult.

So far, the vaccines available to Americans ages 12 and up have sailed through the U.S. Food and Drug Administration’s regulatory checks, taking advantage of an accelerated clearance process called an Emergency Use Authorization (EUA). 

EUAs set a lower bar for effectiveness, saying the vaccines may be safe and effective based on just a few months of data. 

But with COVID cases plummeting in the United States and children historically seeing far less serious disease than adults, a panel of expert advisors to the FDA was asked to deliberate on Thursday whether the agency could consider vaccines for this age group under the same standard. 

Stated another way: Is COVID an emergency for kids? 

There’s another wrinkle in the mix, too – heart inflammation, which appears to be a very rare emerging adverse event tied to vaccination. It seems to happen more often in teens and young adults. To date, cases of myocarditis and pericarditis appear to be happening in 16 to 30 people for every 1 million doses given. 

But if it is conclusively linked to the shots, some wonder whether it might tip the balance between benefits and risks for kids.

That left some of the experts who sit on the FDA’s advisory committee for vaccines and related biological products urging the FDA to take its time and more thoroughly study the shots before they’re given to millions of children.
 

Vaccine studies different in children?

Clinical studies of the vaccines in teens and adults have thus far relied on some straightforward math. You take two groups of similar people. You give half the vaccine and half a placebo. Then you wait and see which group has more symptomatic infections. To date, the vaccines have dramatically cut the risk of getting severely ill with COVID for every age group tested.

But COVID infections are falling rapidly in the U.S., and that may make it more difficult for researchers to conduct a similar kind of experiment in children.

The FDA is considering different approaches to figure out whether a vaccine would be effective in kids, including something called an “immunobridging trial.” 

In bridging trials, researchers don’t look for infections; rather, they look for proven signs that someone has developed immunity, like antibody levels. Those biomarkers are then compared to the immune responses of younger adults who have demonstrated good protection against infection.

The main advantage of bridging studies is speed. It’s possible to get a snapshot of how the immune system responds to a vaccine within weeks of the final dose.

The drawback is that researchers don’t know exactly what to look for to judge how well the shots are generating protection. 

That’s made even more difficult because kids’ immune systems are still developing, so it may be tough to draw direct parallels to adults.

“We don’t know what the serologic correlate of immunity is now. We don’t know how much antibody you have to get in order to be protected. We don’t know what the role of T cells will be,” said H. Cody Meissner, MD, chief of the division of pediatric infectious disease at Tufts Medical Center, Boston.

“I have so much sympathy for the FDA because these are enormous problems, and you have to make a decision,” said Dr. Meissner, who is a member of the FDA’s vaccines and related biological products advisory committee.
 

Speed vaccines to market, or gather more data?

The plummeting rate of infections in the United States also means that it may be more difficult for the FDA to justify allowing a vaccine on the market for emergency use for children under age 12.

In its recent advisory committee meeting, the agency asked the panel whether it should consider COVID vaccines for children under an EUA or a biologics license application (BLA), aka full approval. 

A BLA typically means the agency considers a year or two of data on a new product, rather than just 2 months’ worth. Emergency use also allows products on the market under a looser standard – they “may be” safe and effective, instead of has been proven to be safe and effective.

Several committee members said they didn’t feel the United States was still in an emergency with COVID and couldn’t see the FDA allowing a vaccine to be used in kids that wasn’t given the agency’s highest level of scrutiny, particularly with reports of adverse events like myocarditis coming to light.

“I just want to be sure the price we pay for vaccinating millions of children justifies the side effects, and I don’t think we know that yet,” Dr. Meissner said.

Others acknowledged that there was little risk to kids now with infections on the decline but said that picture could change as variants spread, schools reopen, and colder temperatures force people indoors. 

The FDA must decide whether to act based on where we are now or where we could be in a few months.

“I think it’s the million-dollar question right now,” said Hannah Kirking, MD, a medical epidemiologist with the Centers for Disease Control and Prevention who presented new and unpublished data on COVID’s impact in children to the FDA’s advisory committee.

She said prospective studies tracking the way COVID moves through a household with weekly testing from New York City and Utah had found that children catch and transmit COVID almost as readily as adults. But they don’t usually get as sick as adults do, so their cases are easy to miss. 

She also presented the results of blood tests from samples around the country looking for evidence of past infection. In these seroprevalence studies, about 27% of children under age 17 had antibodies to COVID – the most of any age group. So more than 1 in 4 kids already has some natural immunity.

That means the main benefit of vaccinating children might be the protection of others, while they still bear the risks – however tiny.

Some experts felt that wasn’t enough reason to justify mass distribution of the vaccines to kids, and from a regulatory standpoint, it might not be permissible.

“FDA can only approve a medical product in a population if the benefits outweigh the risks in that population,” said Peter Doshi, PhD, assistant professor of pharmaceutical health services research in the University of Maryland’s school of pharmacy, Baltimore.

“If benefits don’t outweigh risks in children, it can’t be indicated for children. Full stop,” said Dr. Doshi, who is also an editor at the BMJ.

He said there’s another way to give children access to vaccines, through an expanded access or compassionate use program. Because most COVID deaths have been in children with underlying health conditions, Dr. Doshi and others said it might make sense to allow expanded access – which would get vaccines to children at high risk for complications – without turning them loose on millions before they are more thoroughly studied.

“It’s not a particularly attractive option for industry, because there’s no money to be made. Your medicine can’t be commercialized under expanded access. The most you can reap is manufacturing cost, which is not a lot,” he said.

Art Caplan, a professor of bioethics at New York University’s Langone medical center, said the argument for vaccinating children for flu falls along the same lines. The benefit-to-risk ratio is finely balanced in children.  The main value of protecting them is to protect others.

“Flu rarely kills young folks. But you’re really trying to protect old folks and that’s the classic example,” he said.

What’s more, he said the idea that children would take on some risk with a vaccine for little personal benefit is oversimplified.

“Yes, you might get vaccinated to prevent harm to others, but those others are providing benefits to you. It’s not a one-way street. I think that’s a little morally distorted,” Mr. Caplan said. “Being able to keep society open benefits kids and adults alike.”

Other committee members felt like it was too early to sound the all-clear on COVID and said the FDA should authorize vaccines for children as quickly as it had for other age groups.

“We are still, I believe, in an emergency situation. I think that when this virus goes into our children, which is what it’s going to do, that will give it an incubator to change,” said Oveta Fuller, PhD, associate professor of microbiology and immunology at the University of Michigan, Ann Arbor.

Fuller said that for the good of the world, Americans needed to vaccinate children to prevent the virus from mutating and creating new and potentially more dangerous variants.
 

Weighing risk over safety

Beth Thielen, MD, PhD, pediatric infectious disease specialist and virologist at the University of Minnesota, Minneapolis, said she had not followed the committee’s discussions, but about once a month she treats kids who are very sick because of the virus – either because of a COVID infection or because of multisystem inflammatory syndrome (MIS-C), an inflammatory reaction that strikes after infection.

She’s worried about how the virus has already changed. She said the kind of disease she’s seeing in kids now is different than what she saw in the early months of the pandemic.

“In the last couple of months, I’ve actually seen a few cases of severe pulmonary disease, more similar to adult disease in children,” Dr. Thielen said. “I see on the horizon that we could start seeing more significant disease in young people, and then the risks of being unvaccinated go up substantially.” 

But she also knows nobody has a crystal ball, and right now, everything seems to be trending in the right direction with COVID. That makes the risk-to-benefit consideration murkier.

“The question in my mind is, what is the risk of side effects from the vaccine?” she said. “I think we really need to know what the safety profile of vaccine looks like in children because we do have a decent understanding now what risk from disease looks like, because it’s small, but we are seeing it.”

Dr. Thielen said she’ll be keeping an eye on the next meeting of the CDC’s Advisory Committee on Immunization Practices for more answers.

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

Diaphragmatic endometriosis is often diagnosed several years after the start of symptoms – mainly moderate to severe pain – and this is potentially because of general lack of awareness of diaphragmatic endometriosis among the general population and medical professionals.

Findings of the international survey that explored the diagnosis and treatment of diaphragmatic endometriosis were presented at this year’s Royal College of Obstetricians and Gynecologists 2021 Virtual World Congress by medical student Rachel Piccus, MSc, based at the University of Birmingham (England). Robert Sutcliffe, MD, consultant in hepatobiliary and pancreatic surgery, at Queen Elizabeth Hospital Birmingham was senior author. Results were also published in the May 2021 issue of the European Journal of Obstetrics and Gynaecology and Reproductive Biology.

The study found that it took an average of five visits to a primary physician before referral to a gynecologist.

“Late diagnosis could also be due to the idea that diaphragmatic endometriosis symptoms often present before pelvic symptoms and therefore the site of pain is considered atypical for pelvic endometriosis,” Ms. Piccus said, adding that “clinicians are screening for cyclical pain, which is typical of endometriosis, but our study has shown that pain can in fact be more frequent – daily and weekly.”

These significant diagnostic delays, seen from the time of the initial primary care and gynecology consultation has the potential to significantly affect quality of life as seen in pelvic endometriosis, said Ms. Piccus. “These delays are partly due to a lack of awareness among gynecologists, but could also be due to pelvic laparoscopy being insufficient to examine the diaphragm behind the liver.”

Justin Clark, MD, consultant gynaecologist, Birmingham (England) Women’s and Children Hospital, moderated the session and agreed that the study highlights the need for greater awareness of this variant of endometriosis. “Whilst endometriosis affecting the diaphragm, subdiaphragm, and thorax is rare, the condition causes substantial morbidity.”

“Greater knowledge of thoracic endometriosis amongst clinicians in both primary and secondary care is needed to ensure accurate and timely diagnosis,” he added.

Diaphragmatic endometriosis is estimated to affect 1%-1.5% of all endometriosis patients and presents as cyclical pain in the chest, abdomen, and shoulder tip, as well as other respiratory symptoms such as catamenial pneumothorax and difficulty breathing.

“Cross-sectional imaging has shown low sensitivity so upper abdominal laparoscopy is the gold standard; however, this has implications for diagnostic delay because a strong clinical suspicion is required to refer for this invasive procedure,” explained Ms. Piccus referring to one of the reasons underpinning the need for the study.

When successfully diagnosed, treatment requires excision or ablation surgery and studies show symptomatic relief in 75%-100% of cases.

To gauge the extent of delayed diagnosis as well as treatment outcomes from a patient perspective, Ms. Piccus circulated an anonymous online survey among women with a previous history of surgery for diaphragmatic endometriosis.
 

Diaphragmatic endometriosis pain – daily and weekly as well as cyclical

A total of 137 participants responded to the survey, with a median age of 34 years (range, 19-53). Median age of diaphragmatic endometriosis onset was 27 years (range, 11-50), and importantly, diaphragmatic endometriosis symptoms started before pelvic symptoms in 90 respondents (66%).

The dominant symptom was pain. A total of 38% reported cyclical pain (related to endometrial shedding during menstruation), 15% weekly pain, and 47% daily pain, both of which were worse during the menstrual cycle. Furthermore, 14% reported other symptoms including catamenial pneumothorax, difficulty breathing, and hemoptysis.

“Whilst this cyclical pain is typical of endometriosis, we see that diagnostic delays may be due to misdiagnosis because clinicians are screening for this cyclical pain whilst our study has shown that pain can in fact be more frequent, being daily and weekly,” noted Ms. Piccus. Moderate to severe pain was reported in 67% of respondents and moderate in 31%, only 2% reported pain as mild.

Location of pain comprised moderate to severe pain in the upper abdomen (68%), chest (64%) and shoulder (54%). Pain was right-sided in 54%, left-sided in 11% and bilateral in 35%. Upper back and neck were also reported as sites of pain.

Indirectly providing a measure of the lack of awareness of diaphragmatic endometriosis on behalf of primary care, 122 participants reported initially visiting their primary care physician for help and 65 were given a diagnosis – in only 14 cases was that diaphragmatic endometriosis. There were a range of other gynecologic (e.g. ovarian cyst, two), respiratory (spontaneous pneumothorax, seven), gastrointestinal (gastritis/reflux, eight), musculoskeletal (six), and psychological (anxiety/stress, four) diagnoses.

A median of 5 primary care consultations (range, 1-100) were required before referral to a gynecologist, with 30% seeing a primary care physician over 10 times. A further 14 patients self-referred to gynecologist.

“These findings have implications for diagnostic delay, added Ms. Piccus. “While the majority of respondents were diagnosed less than a year from the first GP visit, the median delay was 2 years, with 31% diagnosed after 5 or more years. One took 23 years for an initial diagnosis.”

Most cases were diagnosed at the time of surgery – 93%, with 52% at pelvic laparoscopy, 35% upper abdominal laparoscopy, with 30% requiring two or more laparoscopies before they were diagnosed with diaphragmatic endometriosis. A total of 7% were diagnosed via cross-sectional imaging prior to surgery.
 

Treatment outcomes for diaphragmatic endometriosis

Reflecting the literature, surgery to remove the endometriosis lesions was mainly laparoscopic with 47% abdominal excisions, and 29% abdominal ablations; 6% received open abdominal procedures, and 18% received open thoracotomy or video-assisted thoracoscopic surgery.

The survey asked about postoperative symptoms 6 months after surgery and at the time of survey. Symptoms at 6 months post surgery had completely resolved in 18%, shown significant improvement in 48%, and no improvement in 20%. Worsening of symptoms was seen in 14%. Long-term pain was reported by 21% as severe, 27% as moderate, 35% as mild, and 17% had no symptoms.

Further findings included that 23% underwent additional procedures to treat their diaphragmatic endometriosis, and that there was no significant difference between excision and ablation, nor between age of onset of symptoms or length of diagnostic delay.

“Surgical treatment to remove these extra pelvic deposits of endometriosis will depend upon the type and distribution of thoracic endometriosis and a variety of surgical specialties may need to be involved including gynecologists, cardiothoracic, and upper gastrointestinal/liver surgeons,” Dr. Clark said.

He added that familiar hormonal medical treatments for more typical pelvic endometriosis should also be considered for primary and maintenance treatment. “These data suggest a high symptomatic recurrence rate after surgical treatment and so medical treatments should be considered to try and minimize the risks of endometriosis symptoms returning.”

Dr. Clark also pointed out that multidisciplinary clinical teams should be established in specialized centers to plan surgical and medical management to enhance clinical outcomes and collect data to better understand this enigmatic condition.

Ms. Piccus and Dr. Clark have no relevant conflicts of interest.

Diaphragmatic endometriosis is often diagnosed several years after the start of symptoms – mainly moderate to severe pain – and this is potentially because of general lack of awareness of diaphragmatic endometriosis among the general population and medical professionals.

Findings of the international survey that explored the diagnosis and treatment of diaphragmatic endometriosis were presented at this year’s Royal College of Obstetricians and Gynecologists 2021 Virtual World Congress by medical student Rachel Piccus, MSc, based at the University of Birmingham (England). Robert Sutcliffe, MD, consultant in hepatobiliary and pancreatic surgery, at Queen Elizabeth Hospital Birmingham was senior author. Results were also published in the May 2021 issue of the European Journal of Obstetrics and Gynaecology and Reproductive Biology.

The study found that it took an average of five visits to a primary physician before referral to a gynecologist.

“Late diagnosis could also be due to the idea that diaphragmatic endometriosis symptoms often present before pelvic symptoms and therefore the site of pain is considered atypical for pelvic endometriosis,” Ms. Piccus said, adding that “clinicians are screening for cyclical pain, which is typical of endometriosis, but our study has shown that pain can in fact be more frequent – daily and weekly.”

These significant diagnostic delays, seen from the time of the initial primary care and gynecology consultation has the potential to significantly affect quality of life as seen in pelvic endometriosis, said Ms. Piccus. “These delays are partly due to a lack of awareness among gynecologists, but could also be due to pelvic laparoscopy being insufficient to examine the diaphragm behind the liver.”

Justin Clark, MD, consultant gynaecologist, Birmingham (England) Women’s and Children Hospital, moderated the session and agreed that the study highlights the need for greater awareness of this variant of endometriosis. “Whilst endometriosis affecting the diaphragm, subdiaphragm, and thorax is rare, the condition causes substantial morbidity.”

“Greater knowledge of thoracic endometriosis amongst clinicians in both primary and secondary care is needed to ensure accurate and timely diagnosis,” he added.

Diaphragmatic endometriosis is estimated to affect 1%-1.5% of all endometriosis patients and presents as cyclical pain in the chest, abdomen, and shoulder tip, as well as other respiratory symptoms such as catamenial pneumothorax and difficulty breathing.

“Cross-sectional imaging has shown low sensitivity so upper abdominal laparoscopy is the gold standard; however, this has implications for diagnostic delay because a strong clinical suspicion is required to refer for this invasive procedure,” explained Ms. Piccus referring to one of the reasons underpinning the need for the study.

When successfully diagnosed, treatment requires excision or ablation surgery and studies show symptomatic relief in 75%-100% of cases.

To gauge the extent of delayed diagnosis as well as treatment outcomes from a patient perspective, Ms. Piccus circulated an anonymous online survey among women with a previous history of surgery for diaphragmatic endometriosis.
 

Diaphragmatic endometriosis pain – daily and weekly as well as cyclical

A total of 137 participants responded to the survey, with a median age of 34 years (range, 19-53). Median age of diaphragmatic endometriosis onset was 27 years (range, 11-50), and importantly, diaphragmatic endometriosis symptoms started before pelvic symptoms in 90 respondents (66%).

The dominant symptom was pain. A total of 38% reported cyclical pain (related to endometrial shedding during menstruation), 15% weekly pain, and 47% daily pain, both of which were worse during the menstrual cycle. Furthermore, 14% reported other symptoms including catamenial pneumothorax, difficulty breathing, and hemoptysis.

“Whilst this cyclical pain is typical of endometriosis, we see that diagnostic delays may be due to misdiagnosis because clinicians are screening for this cyclical pain whilst our study has shown that pain can in fact be more frequent, being daily and weekly,” noted Ms. Piccus. Moderate to severe pain was reported in 67% of respondents and moderate in 31%, only 2% reported pain as mild.

Location of pain comprised moderate to severe pain in the upper abdomen (68%), chest (64%) and shoulder (54%). Pain was right-sided in 54%, left-sided in 11% and bilateral in 35%. Upper back and neck were also reported as sites of pain.

Indirectly providing a measure of the lack of awareness of diaphragmatic endometriosis on behalf of primary care, 122 participants reported initially visiting their primary care physician for help and 65 were given a diagnosis – in only 14 cases was that diaphragmatic endometriosis. There were a range of other gynecologic (e.g. ovarian cyst, two), respiratory (spontaneous pneumothorax, seven), gastrointestinal (gastritis/reflux, eight), musculoskeletal (six), and psychological (anxiety/stress, four) diagnoses.

A median of 5 primary care consultations (range, 1-100) were required before referral to a gynecologist, with 30% seeing a primary care physician over 10 times. A further 14 patients self-referred to gynecologist.

“These findings have implications for diagnostic delay, added Ms. Piccus. “While the majority of respondents were diagnosed less than a year from the first GP visit, the median delay was 2 years, with 31% diagnosed after 5 or more years. One took 23 years for an initial diagnosis.”

Most cases were diagnosed at the time of surgery – 93%, with 52% at pelvic laparoscopy, 35% upper abdominal laparoscopy, with 30% requiring two or more laparoscopies before they were diagnosed with diaphragmatic endometriosis. A total of 7% were diagnosed via cross-sectional imaging prior to surgery.
 

Treatment outcomes for diaphragmatic endometriosis

Reflecting the literature, surgery to remove the endometriosis lesions was mainly laparoscopic with 47% abdominal excisions, and 29% abdominal ablations; 6% received open abdominal procedures, and 18% received open thoracotomy or video-assisted thoracoscopic surgery.

The survey asked about postoperative symptoms 6 months after surgery and at the time of survey. Symptoms at 6 months post surgery had completely resolved in 18%, shown significant improvement in 48%, and no improvement in 20%. Worsening of symptoms was seen in 14%. Long-term pain was reported by 21% as severe, 27% as moderate, 35% as mild, and 17% had no symptoms.

Further findings included that 23% underwent additional procedures to treat their diaphragmatic endometriosis, and that there was no significant difference between excision and ablation, nor between age of onset of symptoms or length of diagnostic delay.

“Surgical treatment to remove these extra pelvic deposits of endometriosis will depend upon the type and distribution of thoracic endometriosis and a variety of surgical specialties may need to be involved including gynecologists, cardiothoracic, and upper gastrointestinal/liver surgeons,” Dr. Clark said.

He added that familiar hormonal medical treatments for more typical pelvic endometriosis should also be considered for primary and maintenance treatment. “These data suggest a high symptomatic recurrence rate after surgical treatment and so medical treatments should be considered to try and minimize the risks of endometriosis symptoms returning.”

Dr. Clark also pointed out that multidisciplinary clinical teams should be established in specialized centers to plan surgical and medical management to enhance clinical outcomes and collect data to better understand this enigmatic condition.

Ms. Piccus and Dr. Clark have no relevant conflicts of interest.

Diaphragmatic endometriosis is often diagnosed several years after the start of symptoms – mainly moderate to severe pain – and this is potentially because of general lack of awareness of diaphragmatic endometriosis among the general population and medical professionals.

Findings of the international survey that explored the diagnosis and treatment of diaphragmatic endometriosis were presented at this year’s Royal College of Obstetricians and Gynecologists 2021 Virtual World Congress by medical student Rachel Piccus, MSc, based at the University of Birmingham (England). Robert Sutcliffe, MD, consultant in hepatobiliary and pancreatic surgery, at Queen Elizabeth Hospital Birmingham was senior author. Results were also published in the May 2021 issue of the European Journal of Obstetrics and Gynaecology and Reproductive Biology.

The study found that it took an average of five visits to a primary physician before referral to a gynecologist.

“Late diagnosis could also be due to the idea that diaphragmatic endometriosis symptoms often present before pelvic symptoms and therefore the site of pain is considered atypical for pelvic endometriosis,” Ms. Piccus said, adding that “clinicians are screening for cyclical pain, which is typical of endometriosis, but our study has shown that pain can in fact be more frequent – daily and weekly.”

These significant diagnostic delays, seen from the time of the initial primary care and gynecology consultation has the potential to significantly affect quality of life as seen in pelvic endometriosis, said Ms. Piccus. “These delays are partly due to a lack of awareness among gynecologists, but could also be due to pelvic laparoscopy being insufficient to examine the diaphragm behind the liver.”

Justin Clark, MD, consultant gynaecologist, Birmingham (England) Women’s and Children Hospital, moderated the session and agreed that the study highlights the need for greater awareness of this variant of endometriosis. “Whilst endometriosis affecting the diaphragm, subdiaphragm, and thorax is rare, the condition causes substantial morbidity.”

“Greater knowledge of thoracic endometriosis amongst clinicians in both primary and secondary care is needed to ensure accurate and timely diagnosis,” he added.

Diaphragmatic endometriosis is estimated to affect 1%-1.5% of all endometriosis patients and presents as cyclical pain in the chest, abdomen, and shoulder tip, as well as other respiratory symptoms such as catamenial pneumothorax and difficulty breathing.

“Cross-sectional imaging has shown low sensitivity so upper abdominal laparoscopy is the gold standard; however, this has implications for diagnostic delay because a strong clinical suspicion is required to refer for this invasive procedure,” explained Ms. Piccus referring to one of the reasons underpinning the need for the study.

When successfully diagnosed, treatment requires excision or ablation surgery and studies show symptomatic relief in 75%-100% of cases.

To gauge the extent of delayed diagnosis as well as treatment outcomes from a patient perspective, Ms. Piccus circulated an anonymous online survey among women with a previous history of surgery for diaphragmatic endometriosis.
 

Diaphragmatic endometriosis pain – daily and weekly as well as cyclical

A total of 137 participants responded to the survey, with a median age of 34 years (range, 19-53). Median age of diaphragmatic endometriosis onset was 27 years (range, 11-50), and importantly, diaphragmatic endometriosis symptoms started before pelvic symptoms in 90 respondents (66%).

The dominant symptom was pain. A total of 38% reported cyclical pain (related to endometrial shedding during menstruation), 15% weekly pain, and 47% daily pain, both of which were worse during the menstrual cycle. Furthermore, 14% reported other symptoms including catamenial pneumothorax, difficulty breathing, and hemoptysis.

“Whilst this cyclical pain is typical of endometriosis, we see that diagnostic delays may be due to misdiagnosis because clinicians are screening for this cyclical pain whilst our study has shown that pain can in fact be more frequent, being daily and weekly,” noted Ms. Piccus. Moderate to severe pain was reported in 67% of respondents and moderate in 31%, only 2% reported pain as mild.

Location of pain comprised moderate to severe pain in the upper abdomen (68%), chest (64%) and shoulder (54%). Pain was right-sided in 54%, left-sided in 11% and bilateral in 35%. Upper back and neck were also reported as sites of pain.

Indirectly providing a measure of the lack of awareness of diaphragmatic endometriosis on behalf of primary care, 122 participants reported initially visiting their primary care physician for help and 65 were given a diagnosis – in only 14 cases was that diaphragmatic endometriosis. There were a range of other gynecologic (e.g. ovarian cyst, two), respiratory (spontaneous pneumothorax, seven), gastrointestinal (gastritis/reflux, eight), musculoskeletal (six), and psychological (anxiety/stress, four) diagnoses.

A median of 5 primary care consultations (range, 1-100) were required before referral to a gynecologist, with 30% seeing a primary care physician over 10 times. A further 14 patients self-referred to gynecologist.

“These findings have implications for diagnostic delay, added Ms. Piccus. “While the majority of respondents were diagnosed less than a year from the first GP visit, the median delay was 2 years, with 31% diagnosed after 5 or more years. One took 23 years for an initial diagnosis.”

Most cases were diagnosed at the time of surgery – 93%, with 52% at pelvic laparoscopy, 35% upper abdominal laparoscopy, with 30% requiring two or more laparoscopies before they were diagnosed with diaphragmatic endometriosis. A total of 7% were diagnosed via cross-sectional imaging prior to surgery.
 

Treatment outcomes for diaphragmatic endometriosis

Reflecting the literature, surgery to remove the endometriosis lesions was mainly laparoscopic with 47% abdominal excisions, and 29% abdominal ablations; 6% received open abdominal procedures, and 18% received open thoracotomy or video-assisted thoracoscopic surgery.

The survey asked about postoperative symptoms 6 months after surgery and at the time of survey. Symptoms at 6 months post surgery had completely resolved in 18%, shown significant improvement in 48%, and no improvement in 20%. Worsening of symptoms was seen in 14%. Long-term pain was reported by 21% as severe, 27% as moderate, 35% as mild, and 17% had no symptoms.

Further findings included that 23% underwent additional procedures to treat their diaphragmatic endometriosis, and that there was no significant difference between excision and ablation, nor between age of onset of symptoms or length of diagnostic delay.

“Surgical treatment to remove these extra pelvic deposits of endometriosis will depend upon the type and distribution of thoracic endometriosis and a variety of surgical specialties may need to be involved including gynecologists, cardiothoracic, and upper gastrointestinal/liver surgeons,” Dr. Clark said.

He added that familiar hormonal medical treatments for more typical pelvic endometriosis should also be considered for primary and maintenance treatment. “These data suggest a high symptomatic recurrence rate after surgical treatment and so medical treatments should be considered to try and minimize the risks of endometriosis symptoms returning.”

Dr. Clark also pointed out that multidisciplinary clinical teams should be established in specialized centers to plan surgical and medical management to enhance clinical outcomes and collect data to better understand this enigmatic condition.

Ms. Piccus and Dr. Clark have no relevant conflicts of interest.

Telemedicine has been proposed as a solution for an array of health care access problems over decades of gradual growth. The vast ramping up of telemedicine during the COVID-19 pandemic greatly expanded the evidence of its feasibility and what appears to be its inevitable incorporation into models of care, according to an update at the annual health policy and advocacy conference sponsored by the American College of Chest Physicians.

American College of Chest Physicians Health Policy and Advocacy

“The cat is out of the bag,” said Jaspal Singh, MD, professor of medicine, Atrium Health, Charlotte, N.C. Due to changes in access and reimbursement to telemedicine driven by the pandemic, he said, “we now have permission to explore new models of care.”

Prior to February 2020, telemedicine was crawling forward at a leisurely pace, according to Dr. Singh. After March 2020, it broke into a run due to enormous demand and was met by a rapid response from the U.S. Congress. The first of four legislative bills that directly or indirectly supported telemedicine was passed on March 6, 2020.

The Centers for Medicare and Medicaid Services responded in kind, making modifications in a number of rules that removed obstacles to telehealth. One modification on April 6, 2020, for example, removed the requirement for a preexisting relationship between the clinician and patient, Dr. Singh said. The CMS also subsequently modified reimbursement policies in order to make telemedicine more tenable for physicians.

Given the risk of contagion from face-to-face encounters, telemedicine in the early days of the pandemic was not just attractive but the only practical and safe approach to medical care in many circumstances. Physicians and patients were anxious for health care that did not require in-office visits even though many critical issues for telemedicine, including its relative effectiveness, had not yet been fully evaluated.

Much has been learned regarding the feasibility and acceptability of telemedicine during the pandemic, but Dr. Singh noted that quality of care relative to in-person visits remains weakly supported for most indications. Indeed, he outlined sizable list of incompletely resolved issues, including optimal payment models, management of privacy concerns, and how to balance advantages to disadvantages.

For patients and physicians, the strengths of telemedicine include greater convenience made possible by the elimination of travel and waiting rooms. For the health care system, it can include less infrastructure and overhead. For many physicians, telemedicine might be perceived as more efficient.

On the other hand, some patients might feel that a clinical encounter is incomplete without a physical examination even when the physician does not feel the physical examination is needed, according to Dr. Singh. He cited a survey suggesting nearly half of patients expressed concern about a lack of connection to health care providers following a virtual visit.

In the same 2020 National Poll on Healthy Aging 2020 survey conducted by the University of Michigan 67% of respondents reported that the quality of care was not as good as that provided by in-patient visits, and 24% expressed concern about privacy. However, at the time the poll was taken in May 2020, experience with telemedicine among many of the respondents may have been limited. As telemedicine is integrated into routine care, perceptions might change as experience increases.

A distinction between telemedicine in routine care and telemedicine as a strategy to respond to a pandemic is important, Dr. Singh indicated. Dr. Singh was the lead author for a position paper on telemedicine for the diagnosis and treatment of sleep disorders from the American Academy of Sleep Medicine 5 years ago, but he acknowledged that models of care might differ when responding to abnormal surges in health care demand.

The surge in demand for COVID-19–related care engendered numerous innovative solutions. As examples, Dr. Singh recounted how a virtual hospital was created at his own institution. In a published study, 1,477 patients diagnosed with COVID-19 over a 6-week period remained at home and received care in a virtual observation unit (VCU) or a virtual acute care unit (VACU) . Only a small percentage required eventual hospital admission. In the VACU, patients were able to receive advanced care including IV fluids and some form of respiratory support .

It is unclear how the COVID-19 pandemic will change telemedicine. Now, with declining cases of the infection, telemedicine is back to a walk after the sprint required during the height of the pandemic, according to Dr. Singh. However, Dr. Singh thinks many physicians and patients will have a different perception of telemedicine after the widespread exposure to this type of care.

In terms of the relative role of in-patient and virtual visits across indications, “we do not know how this will play out, but we will probably end up toggling between the two,” Dr. Singh said.

This is an area that is being followed closely by the CHEST Health Policy and Advocacy Committee, according to Kathleen Sarmiento, MD, director, VISN 21 Sleep Clinical Resource Hub for the San Francisco VA Health Care System. A member of that committee and moderator of the session in which Dr. Singh spoke,

American College of Chest Physicians Health Policy and Advocacy Conference

Dr. Sarmiento called the effort to bring permanent coverage of telehealth services “the shared responsibility of every medical society engaged in advocacy.”

However, she cautioned that there might be intended and unintended consequences from telehealth that require analysis to develop policies that are in the best interests of effective care. She said, the “ACCP, along with its sister societies, does have a role in supporting the evaluation of the impact of these changes on both patients and providers in the fields of pulmonary medicine, critical care, and sleep medicine.”

Dr. Singh reports a financial relationship with AstraZeneca. Dr. Sarmiento reports no relevant financial relationship with AstraZeneca.

Telemedicine has been proposed as a solution for an array of health care access problems over decades of gradual growth. The vast ramping up of telemedicine during the COVID-19 pandemic greatly expanded the evidence of its feasibility and what appears to be its inevitable incorporation into models of care, according to an update at the annual health policy and advocacy conference sponsored by the American College of Chest Physicians.

American College of Chest Physicians Health Policy and Advocacy

“The cat is out of the bag,” said Jaspal Singh, MD, professor of medicine, Atrium Health, Charlotte, N.C. Due to changes in access and reimbursement to telemedicine driven by the pandemic, he said, “we now have permission to explore new models of care.”

Prior to February 2020, telemedicine was crawling forward at a leisurely pace, according to Dr. Singh. After March 2020, it broke into a run due to enormous demand and was met by a rapid response from the U.S. Congress. The first of four legislative bills that directly or indirectly supported telemedicine was passed on March 6, 2020.

The Centers for Medicare and Medicaid Services responded in kind, making modifications in a number of rules that removed obstacles to telehealth. One modification on April 6, 2020, for example, removed the requirement for a preexisting relationship between the clinician and patient, Dr. Singh said. The CMS also subsequently modified reimbursement policies in order to make telemedicine more tenable for physicians.

Given the risk of contagion from face-to-face encounters, telemedicine in the early days of the pandemic was not just attractive but the only practical and safe approach to medical care in many circumstances. Physicians and patients were anxious for health care that did not require in-office visits even though many critical issues for telemedicine, including its relative effectiveness, had not yet been fully evaluated.

Much has been learned regarding the feasibility and acceptability of telemedicine during the pandemic, but Dr. Singh noted that quality of care relative to in-person visits remains weakly supported for most indications. Indeed, he outlined sizable list of incompletely resolved issues, including optimal payment models, management of privacy concerns, and how to balance advantages to disadvantages.

For patients and physicians, the strengths of telemedicine include greater convenience made possible by the elimination of travel and waiting rooms. For the health care system, it can include less infrastructure and overhead. For many physicians, telemedicine might be perceived as more efficient.

On the other hand, some patients might feel that a clinical encounter is incomplete without a physical examination even when the physician does not feel the physical examination is needed, according to Dr. Singh. He cited a survey suggesting nearly half of patients expressed concern about a lack of connection to health care providers following a virtual visit.

In the same 2020 National Poll on Healthy Aging 2020 survey conducted by the University of Michigan 67% of respondents reported that the quality of care was not as good as that provided by in-patient visits, and 24% expressed concern about privacy. However, at the time the poll was taken in May 2020, experience with telemedicine among many of the respondents may have been limited. As telemedicine is integrated into routine care, perceptions might change as experience increases.

A distinction between telemedicine in routine care and telemedicine as a strategy to respond to a pandemic is important, Dr. Singh indicated. Dr. Singh was the lead author for a position paper on telemedicine for the diagnosis and treatment of sleep disorders from the American Academy of Sleep Medicine 5 years ago, but he acknowledged that models of care might differ when responding to abnormal surges in health care demand.

The surge in demand for COVID-19–related care engendered numerous innovative solutions. As examples, Dr. Singh recounted how a virtual hospital was created at his own institution. In a published study, 1,477 patients diagnosed with COVID-19 over a 6-week period remained at home and received care in a virtual observation unit (VCU) or a virtual acute care unit (VACU) . Only a small percentage required eventual hospital admission. In the VACU, patients were able to receive advanced care including IV fluids and some form of respiratory support .

It is unclear how the COVID-19 pandemic will change telemedicine. Now, with declining cases of the infection, telemedicine is back to a walk after the sprint required during the height of the pandemic, according to Dr. Singh. However, Dr. Singh thinks many physicians and patients will have a different perception of telemedicine after the widespread exposure to this type of care.

In terms of the relative role of in-patient and virtual visits across indications, “we do not know how this will play out, but we will probably end up toggling between the two,” Dr. Singh said.

This is an area that is being followed closely by the CHEST Health Policy and Advocacy Committee, according to Kathleen Sarmiento, MD, director, VISN 21 Sleep Clinical Resource Hub for the San Francisco VA Health Care System. A member of that committee and moderator of the session in which Dr. Singh spoke,

American College of Chest Physicians Health Policy and Advocacy Conference

Dr. Sarmiento called the effort to bring permanent coverage of telehealth services “the shared responsibility of every medical society engaged in advocacy.”

However, she cautioned that there might be intended and unintended consequences from telehealth that require analysis to develop policies that are in the best interests of effective care. She said, the “ACCP, along with its sister societies, does have a role in supporting the evaluation of the impact of these changes on both patients and providers in the fields of pulmonary medicine, critical care, and sleep medicine.”

Dr. Singh reports a financial relationship with AstraZeneca. Dr. Sarmiento reports no relevant financial relationship with AstraZeneca.

Telemedicine has been proposed as a solution for an array of health care access problems over decades of gradual growth. The vast ramping up of telemedicine during the COVID-19 pandemic greatly expanded the evidence of its feasibility and what appears to be its inevitable incorporation into models of care, according to an update at the annual health policy and advocacy conference sponsored by the American College of Chest Physicians.

American College of Chest Physicians Health Policy and Advocacy

“The cat is out of the bag,” said Jaspal Singh, MD, professor of medicine, Atrium Health, Charlotte, N.C. Due to changes in access and reimbursement to telemedicine driven by the pandemic, he said, “we now have permission to explore new models of care.”

Prior to February 2020, telemedicine was crawling forward at a leisurely pace, according to Dr. Singh. After March 2020, it broke into a run due to enormous demand and was met by a rapid response from the U.S. Congress. The first of four legislative bills that directly or indirectly supported telemedicine was passed on March 6, 2020.

The Centers for Medicare and Medicaid Services responded in kind, making modifications in a number of rules that removed obstacles to telehealth. One modification on April 6, 2020, for example, removed the requirement for a preexisting relationship between the clinician and patient, Dr. Singh said. The CMS also subsequently modified reimbursement policies in order to make telemedicine more tenable for physicians.

Given the risk of contagion from face-to-face encounters, telemedicine in the early days of the pandemic was not just attractive but the only practical and safe approach to medical care in many circumstances. Physicians and patients were anxious for health care that did not require in-office visits even though many critical issues for telemedicine, including its relative effectiveness, had not yet been fully evaluated.

Much has been learned regarding the feasibility and acceptability of telemedicine during the pandemic, but Dr. Singh noted that quality of care relative to in-person visits remains weakly supported for most indications. Indeed, he outlined sizable list of incompletely resolved issues, including optimal payment models, management of privacy concerns, and how to balance advantages to disadvantages.

For patients and physicians, the strengths of telemedicine include greater convenience made possible by the elimination of travel and waiting rooms. For the health care system, it can include less infrastructure and overhead. For many physicians, telemedicine might be perceived as more efficient.

On the other hand, some patients might feel that a clinical encounter is incomplete without a physical examination even when the physician does not feel the physical examination is needed, according to Dr. Singh. He cited a survey suggesting nearly half of patients expressed concern about a lack of connection to health care providers following a virtual visit.

In the same 2020 National Poll on Healthy Aging 2020 survey conducted by the University of Michigan 67% of respondents reported that the quality of care was not as good as that provided by in-patient visits, and 24% expressed concern about privacy. However, at the time the poll was taken in May 2020, experience with telemedicine among many of the respondents may have been limited. As telemedicine is integrated into routine care, perceptions might change as experience increases.

A distinction between telemedicine in routine care and telemedicine as a strategy to respond to a pandemic is important, Dr. Singh indicated. Dr. Singh was the lead author for a position paper on telemedicine for the diagnosis and treatment of sleep disorders from the American Academy of Sleep Medicine 5 years ago, but he acknowledged that models of care might differ when responding to abnormal surges in health care demand.

The surge in demand for COVID-19–related care engendered numerous innovative solutions. As examples, Dr. Singh recounted how a virtual hospital was created at his own institution. In a published study, 1,477 patients diagnosed with COVID-19 over a 6-week period remained at home and received care in a virtual observation unit (VCU) or a virtual acute care unit (VACU) . Only a small percentage required eventual hospital admission. In the VACU, patients were able to receive advanced care including IV fluids and some form of respiratory support .

It is unclear how the COVID-19 pandemic will change telemedicine. Now, with declining cases of the infection, telemedicine is back to a walk after the sprint required during the height of the pandemic, according to Dr. Singh. However, Dr. Singh thinks many physicians and patients will have a different perception of telemedicine after the widespread exposure to this type of care.

In terms of the relative role of in-patient and virtual visits across indications, “we do not know how this will play out, but we will probably end up toggling between the two,” Dr. Singh said.

This is an area that is being followed closely by the CHEST Health Policy and Advocacy Committee, according to Kathleen Sarmiento, MD, director, VISN 21 Sleep Clinical Resource Hub for the San Francisco VA Health Care System. A member of that committee and moderator of the session in which Dr. Singh spoke,

American College of Chest Physicians Health Policy and Advocacy Conference

Dr. Sarmiento called the effort to bring permanent coverage of telehealth services “the shared responsibility of every medical society engaged in advocacy.”

However, she cautioned that there might be intended and unintended consequences from telehealth that require analysis to develop policies that are in the best interests of effective care. She said, the “ACCP, along with its sister societies, does have a role in supporting the evaluation of the impact of these changes on both patients and providers in the fields of pulmonary medicine, critical care, and sleep medicine.”

Dr. Singh reports a financial relationship with AstraZeneca. Dr. Sarmiento reports no relevant financial relationship with AstraZeneca.

Prophylactic anticoagulation to prevent venous thromboembolism (VTE) was associated with reduced 60-day mortality in patients with COVID-19 who were ill enough to require hospitalization, a new report shows.

In a cohort study of more than 1,300 hospitalized patients with COVID-19 infection across 30 hospitals in Michigan, both prophylactic- and therapeutic-dose anticoagulation were associated with reduced in-hospital mortality; however, at 60 days, only prophylactic-dose anticoagulation remained associated with lower mortality.

And adherence was key; nonadherence, or missing 2 days or more of anticoagulation, was linked to more deaths at 60 days.

The findings, which were published online June 11 in JAMA Network Open, are final proof that a prophylactic anticoagulation strategy for the hospitalized COVID population is, indeed, the right one, Valerie M. Vaughn, MD, director of hospital medicine research at the University of Utah, Salt Lake City, said in an interview.

“We’ve probably always known that patients with COVID need prophylaxis for VTE, but we found that early on, unfortunately, that wasn’t being done,” Dr. Vaughn said.

“Now, we see that prophylactic rates have increased. We always knew to use anticoagulation prophylactically in patients who were hospitalized with infection because of their risk for VTE, so this study just drives home that proper adherence to an anticoagulation protocol improves mortality,” she said.

Dr. Vaughn was on the front lines when COVID-19 came to Michigan, where the research was conducted.

“We probably should have been anticoagulating from the get-go, but you have to remember that in the early days of COVID, the hospitals in Michigan were being overwhelmed. They didn’t have PPE. They were taking care of patients outside of their typical hospital beds or setting up field hospitals,” she said. “It was not quite as bad as New York, but at the University of Michigan, we set up four or five ICUs outside of our normal care.”

They also converted the top floor of their pediatric hospital into an ICU to take care of patients with COVID during the first surge, she added. “We didn’t know much about this disease, but faced with this influx of patients, many of whom were dying with blood clots, we had to do something.”  

Some hospitals began prophylactically anticoagulating their patients, but others hesitated before adopting the strategy. “But now we feel confident that prophylactic anticoagulation, done according to the right protocol, with no interruptions in the treatment, is beneficial,” Dr. Vaughn said.

The best medication choice is enoxaparin (Lovenox), which can be given once a day, as opposed to heparin, which needs to be given via injection three times a day, she said.

“Prophylactic dose anticoagulation is typically given by an injection under the skin, but a lot of times, I’ve had patients tell me they feel like a human pin cushion and have all these bruises from being stuck with needles every day, which I can totally relate to,” she said.

“It is important for us as clinicians to explain that we’re having to poke our patients because it is good for them and will help them fight COVID,” she added. “Also having the once-a-day option is going to be a lot better for adherence, and adherence to the protocol, not missing any days, is key to the better outcome.”

Dr. Vaughn and her team reviewed the charts of 1,351 patients (48% women, 49% Black, median age 64 [range 52-75]) who were hospitalized throughout Michigan during the first several months of the COVID-19 pandemic, from March to June 2020.

Only 18 patients (1.3%) had a confirmed VTE and 219 patients (16.2%) received treatment-dose anticoagulation.

The researchers noted that use of treatment-dose anticoagulation without imaging ranged from 0% to 29% across hospitals and increased significantly over time.

Of the 1,127 patients who received anticoagulation, 392 (34.8%) missed 2 days or more of prophylaxis.

In addition, there were varying rates of missed prophylaxis among the hospitals, from 11% to 61%, but these rates decreased markedly over time.

Missed doses were associated with a higher 60-day mortality (adjusted hazard ratio, 1.31; 95% confidence interval, 1.03-1.67), but not in-hospital mortality (aHR, 0.97; 95% CI, 0.91-1.03).

Compared with no anticoagulation, receiving any dose of anticoagulation was associated with lower in-hospital mortality.

However, only prophylactic-dose anticoagulation remained associated with lower mortality at 60 days. The adjusted hazard ratio for prophylactic-dose anticoagulation was 0.71 (95% CI, 0.51-0.90), compared with 0.92 (95% CI, 0.63-1.35) for treatment-dose anticoagulation.
 

Study boosts confidence

Despite its limitations, the study should make clinicians more confident that the use of prophylactic anticoagulation is warranted for hospitalized patients with COVID-19, write Andrew B. Dicks, MD, and Ido Weinberg, MD, from Massachusetts General Hospital, Boston, in an invited commentary.

“Practically, we still lack the granular data we need to help guide us in patient-by-patient decision-making – such as anticoagulation agent choice, dosage, and duration of therapy – especially as dictated by acuity of patient illness,” Dr. Dicks and Dr. Weinberg note.

“While we still await the data from randomized controlled trials to guide the optimal anticoagulation dose and duration, this study adds significant merit to the previously published recommendations from several different medical organizations regarding the use of prophylactic anticoagulation in hospitalized patients with COVID-19,” Dr. Dicks told this news organization.

The study was supported by Blue Cross and Blue Shield of Michigan and Blue Care Network as part of their Value Partnerships program. Dr. Vaughn has reported receiving speaking fees from Thermo Fisher Scientific. Dr. Dicks and Dr. Weinberg have reported no relevant financial relationships.

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

Prophylactic anticoagulation to prevent venous thromboembolism (VTE) was associated with reduced 60-day mortality in patients with COVID-19 who were ill enough to require hospitalization, a new report shows.

In a cohort study of more than 1,300 hospitalized patients with COVID-19 infection across 30 hospitals in Michigan, both prophylactic- and therapeutic-dose anticoagulation were associated with reduced in-hospital mortality; however, at 60 days, only prophylactic-dose anticoagulation remained associated with lower mortality.

And adherence was key; nonadherence, or missing 2 days or more of anticoagulation, was linked to more deaths at 60 days.

The findings, which were published online June 11 in JAMA Network Open, are final proof that a prophylactic anticoagulation strategy for the hospitalized COVID population is, indeed, the right one, Valerie M. Vaughn, MD, director of hospital medicine research at the University of Utah, Salt Lake City, said in an interview.

“We’ve probably always known that patients with COVID need prophylaxis for VTE, but we found that early on, unfortunately, that wasn’t being done,” Dr. Vaughn said.

“Now, we see that prophylactic rates have increased. We always knew to use anticoagulation prophylactically in patients who were hospitalized with infection because of their risk for VTE, so this study just drives home that proper adherence to an anticoagulation protocol improves mortality,” she said.

Dr. Vaughn was on the front lines when COVID-19 came to Michigan, where the research was conducted.

“We probably should have been anticoagulating from the get-go, but you have to remember that in the early days of COVID, the hospitals in Michigan were being overwhelmed. They didn’t have PPE. They were taking care of patients outside of their typical hospital beds or setting up field hospitals,” she said. “It was not quite as bad as New York, but at the University of Michigan, we set up four or five ICUs outside of our normal care.”

They also converted the top floor of their pediatric hospital into an ICU to take care of patients with COVID during the first surge, she added. “We didn’t know much about this disease, but faced with this influx of patients, many of whom were dying with blood clots, we had to do something.”  

Some hospitals began prophylactically anticoagulating their patients, but others hesitated before adopting the strategy. “But now we feel confident that prophylactic anticoagulation, done according to the right protocol, with no interruptions in the treatment, is beneficial,” Dr. Vaughn said.

The best medication choice is enoxaparin (Lovenox), which can be given once a day, as opposed to heparin, which needs to be given via injection three times a day, she said.

“Prophylactic dose anticoagulation is typically given by an injection under the skin, but a lot of times, I’ve had patients tell me they feel like a human pin cushion and have all these bruises from being stuck with needles every day, which I can totally relate to,” she said.

“It is important for us as clinicians to explain that we’re having to poke our patients because it is good for them and will help them fight COVID,” she added. “Also having the once-a-day option is going to be a lot better for adherence, and adherence to the protocol, not missing any days, is key to the better outcome.”

Dr. Vaughn and her team reviewed the charts of 1,351 patients (48% women, 49% Black, median age 64 [range 52-75]) who were hospitalized throughout Michigan during the first several months of the COVID-19 pandemic, from March to June 2020.

Only 18 patients (1.3%) had a confirmed VTE and 219 patients (16.2%) received treatment-dose anticoagulation.

The researchers noted that use of treatment-dose anticoagulation without imaging ranged from 0% to 29% across hospitals and increased significantly over time.

Of the 1,127 patients who received anticoagulation, 392 (34.8%) missed 2 days or more of prophylaxis.

In addition, there were varying rates of missed prophylaxis among the hospitals, from 11% to 61%, but these rates decreased markedly over time.

Missed doses were associated with a higher 60-day mortality (adjusted hazard ratio, 1.31; 95% confidence interval, 1.03-1.67), but not in-hospital mortality (aHR, 0.97; 95% CI, 0.91-1.03).

Compared with no anticoagulation, receiving any dose of anticoagulation was associated with lower in-hospital mortality.

However, only prophylactic-dose anticoagulation remained associated with lower mortality at 60 days. The adjusted hazard ratio for prophylactic-dose anticoagulation was 0.71 (95% CI, 0.51-0.90), compared with 0.92 (95% CI, 0.63-1.35) for treatment-dose anticoagulation.
 

Study boosts confidence

Despite its limitations, the study should make clinicians more confident that the use of prophylactic anticoagulation is warranted for hospitalized patients with COVID-19, write Andrew B. Dicks, MD, and Ido Weinberg, MD, from Massachusetts General Hospital, Boston, in an invited commentary.

“Practically, we still lack the granular data we need to help guide us in patient-by-patient decision-making – such as anticoagulation agent choice, dosage, and duration of therapy – especially as dictated by acuity of patient illness,” Dr. Dicks and Dr. Weinberg note.

“While we still await the data from randomized controlled trials to guide the optimal anticoagulation dose and duration, this study adds significant merit to the previously published recommendations from several different medical organizations regarding the use of prophylactic anticoagulation in hospitalized patients with COVID-19,” Dr. Dicks told this news organization.

The study was supported by Blue Cross and Blue Shield of Michigan and Blue Care Network as part of their Value Partnerships program. Dr. Vaughn has reported receiving speaking fees from Thermo Fisher Scientific. Dr. Dicks and Dr. Weinberg have reported no relevant financial relationships.

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

Prophylactic anticoagulation to prevent venous thromboembolism (VTE) was associated with reduced 60-day mortality in patients with COVID-19 who were ill enough to require hospitalization, a new report shows.

In a cohort study of more than 1,300 hospitalized patients with COVID-19 infection across 30 hospitals in Michigan, both prophylactic- and therapeutic-dose anticoagulation were associated with reduced in-hospital mortality; however, at 60 days, only prophylactic-dose anticoagulation remained associated with lower mortality.

And adherence was key; nonadherence, or missing 2 days or more of anticoagulation, was linked to more deaths at 60 days.

The findings, which were published online June 11 in JAMA Network Open, are final proof that a prophylactic anticoagulation strategy for the hospitalized COVID population is, indeed, the right one, Valerie M. Vaughn, MD, director of hospital medicine research at the University of Utah, Salt Lake City, said in an interview.

“We’ve probably always known that patients with COVID need prophylaxis for VTE, but we found that early on, unfortunately, that wasn’t being done,” Dr. Vaughn said.

“Now, we see that prophylactic rates have increased. We always knew to use anticoagulation prophylactically in patients who were hospitalized with infection because of their risk for VTE, so this study just drives home that proper adherence to an anticoagulation protocol improves mortality,” she said.

Dr. Vaughn was on the front lines when COVID-19 came to Michigan, where the research was conducted.

“We probably should have been anticoagulating from the get-go, but you have to remember that in the early days of COVID, the hospitals in Michigan were being overwhelmed. They didn’t have PPE. They were taking care of patients outside of their typical hospital beds or setting up field hospitals,” she said. “It was not quite as bad as New York, but at the University of Michigan, we set up four or five ICUs outside of our normal care.”

They also converted the top floor of their pediatric hospital into an ICU to take care of patients with COVID during the first surge, she added. “We didn’t know much about this disease, but faced with this influx of patients, many of whom were dying with blood clots, we had to do something.”  

Some hospitals began prophylactically anticoagulating their patients, but others hesitated before adopting the strategy. “But now we feel confident that prophylactic anticoagulation, done according to the right protocol, with no interruptions in the treatment, is beneficial,” Dr. Vaughn said.

The best medication choice is enoxaparin (Lovenox), which can be given once a day, as opposed to heparin, which needs to be given via injection three times a day, she said.

“Prophylactic dose anticoagulation is typically given by an injection under the skin, but a lot of times, I’ve had patients tell me they feel like a human pin cushion and have all these bruises from being stuck with needles every day, which I can totally relate to,” she said.

“It is important for us as clinicians to explain that we’re having to poke our patients because it is good for them and will help them fight COVID,” she added. “Also having the once-a-day option is going to be a lot better for adherence, and adherence to the protocol, not missing any days, is key to the better outcome.”

Dr. Vaughn and her team reviewed the charts of 1,351 patients (48% women, 49% Black, median age 64 [range 52-75]) who were hospitalized throughout Michigan during the first several months of the COVID-19 pandemic, from March to June 2020.

Only 18 patients (1.3%) had a confirmed VTE and 219 patients (16.2%) received treatment-dose anticoagulation.

The researchers noted that use of treatment-dose anticoagulation without imaging ranged from 0% to 29% across hospitals and increased significantly over time.

Of the 1,127 patients who received anticoagulation, 392 (34.8%) missed 2 days or more of prophylaxis.

In addition, there were varying rates of missed prophylaxis among the hospitals, from 11% to 61%, but these rates decreased markedly over time.

Missed doses were associated with a higher 60-day mortality (adjusted hazard ratio, 1.31; 95% confidence interval, 1.03-1.67), but not in-hospital mortality (aHR, 0.97; 95% CI, 0.91-1.03).

Compared with no anticoagulation, receiving any dose of anticoagulation was associated with lower in-hospital mortality.

However, only prophylactic-dose anticoagulation remained associated with lower mortality at 60 days. The adjusted hazard ratio for prophylactic-dose anticoagulation was 0.71 (95% CI, 0.51-0.90), compared with 0.92 (95% CI, 0.63-1.35) for treatment-dose anticoagulation.
 

Study boosts confidence

Despite its limitations, the study should make clinicians more confident that the use of prophylactic anticoagulation is warranted for hospitalized patients with COVID-19, write Andrew B. Dicks, MD, and Ido Weinberg, MD, from Massachusetts General Hospital, Boston, in an invited commentary.

“Practically, we still lack the granular data we need to help guide us in patient-by-patient decision-making – such as anticoagulation agent choice, dosage, and duration of therapy – especially as dictated by acuity of patient illness,” Dr. Dicks and Dr. Weinberg note.

“While we still await the data from randomized controlled trials to guide the optimal anticoagulation dose and duration, this study adds significant merit to the previously published recommendations from several different medical organizations regarding the use of prophylactic anticoagulation in hospitalized patients with COVID-19,” Dr. Dicks told this news organization.

The study was supported by Blue Cross and Blue Shield of Michigan and Blue Care Network as part of their Value Partnerships program. Dr. Vaughn has reported receiving speaking fees from Thermo Fisher Scientific. Dr. Dicks and Dr. Weinberg have reported no relevant financial relationships.

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

In the absence of formal clinical trials, pediatricians are racing to determine the efficacy and risks of currently used therapies for the SARS-CoV-2–linked multisystem inflammatory syndrome in children (MIS-C).

That requires rapid pragmatic evaluation of therapies. Two real-world observational studies published online June 16 in The New England Journal of Medicine do that, with differing results.

In the Overcoming COVID-19 study, investigators assessed initial therapy and outcomes for patients with MIS-C using surveillance data from 58 pediatric hospitals nationwide.

The results suggest that patients with MIS-C who were younger than 21 years of age and who were initially treated with intravenous immunoglobulin (IVIG) plus glucocorticoids fared better in terms of cardiovascular function.

The study included 518 children (median age, 8.7 years) who were admitted to the hospital between March and October 2020 and who received at least one immunomodulatory therapy. In a propensity score–matched analysis, those given IVIG plus glucocorticoids (n = 103) had a lower risk for the primary outcome of cardiovascular dysfunction on or after day 2 than those given IVIG alone (n = 103), at 17% versus 31% (risk ratio, 0.56; 95% confidence interval, 0.34-0.94).

Risks for individual aspects of the study’s composite outcome were also lower with IVIG plus glucocorticoids. Left ventricular dysfunction occurred in 8% and 17%, respectively (RR, 0.46; 95% CI, 0.19-1.15). Shock requiring vasopressor use emerged in 13% and 24%, respectively (RR, 0.54; 95% CI, 0.29-1.00).

In addition, there were fewer cases in which adjunctive therapy was given on day one among those who received combination therapy than among those who received IVIG alone, at 34% versus 70% (RR, 0.49; 95% CI, 0.36-0.65), but the risk for fever was not lower on or after day two (31% and 40%, respectively; RR, 0.78; 95% CI, 0.53-1.13).

Lead author Mary Beth F. Son, MD, director of the rheumatology program at Boston Children’s Hospital, who is also associate professor of pediatrics at Harvard Medical School, stressed that the study did not assess which MIS-C patients should receive treatment. “Rather, we studied children who had been treated with one of two initial regimens and then assessed short-term outcomes,” she told this news organization.

Going forward, it will be important to study which children should receive immunomodulatory treatment, Dr. Son said. “Specifically, can the less ill children receive IVIG alone or no treatment? This is an unanswered question at the moment, which could be addressed with a randomized controlled trial.”

Future directions, she added, will include assessing long-term cardiac outcomes for patients with MIS-C as well as studying outpatient regimens, especially those that involve steroids.

Earlier this year, French investigators found better outcomes with combined corticosteroids and IVIG than with IVIG alone. They suggested that combination therapy should be the standard of care, given the present state of therapeutic knowledge.
 

Maybe not so standard

Different results emerged, however, from an international study of MIS-C that compared three, rather than two, treatment approaches. Collaborators from the Best Available Treatment Study for MIS-C (BATS) evaluated data for 614 children with suspected MIS-C between June 2020 and February 2021 in 32 countries and found no substantial differences in recovery among children whose primary treatment was IVIG alone, IVIG plus glucocorticoids, or glucocorticoids alone.

The study by Andrew J. McArdle, MB BChir, MSC, a clinical research fellow at Imperial College London, and colleagues was published June 16 in The New England Journal of Medicine.

In the BATS cohort, 246 received IVIG alone, 208 received IVIG plus glucocorticoids, and 99 received glucocorticoids alone. Twenty-two patients received other combinations, including biologics, and 39 received no immunomodulatory therapy.

Among patients who were included in the primary analysis, death occurred or inotropic or ventilatory support was employed in 56 of 180 of the patients who received IVIG plus glucocorticoids, compared with 44 of 211 patients treated with IVIG alone, for an adjusted odds ratio (aOR) of 0.77 (95% CI, 0.33-1.82). Among those who received glucocorticoids alone, 17 of 83 met the primary endpoint of death or inotropic or ventilatory support, for an aOR relative to IVIG alone of 0.54 (95% CI, 0.22-1.33).

After adjustments, the likelihood for reduced disease severity was similar in the two groups relative to IVIG alone, at 0.90 for IVIG plus glucocorticoids and 0.93 for glucocorticoids alone. Time to reduction in disease severity was also comparable across all groups.

Some of the differences between the U.S. study and the global studies could be the result of the larger size of the international cohort and possibly a difference in the strains of virus in the United States and abroad, according to S. Sexson Tejtel, MD, PhD, MPH, a pediatric cardiologist at Texas Children’s Hospital and an assistant professor at Baylor College of Medicine, Houston, Texas. “Some strains make children sicker than others, and they’re going to need more treatment,” said Dr. Sexson Tejtel, who was not involved in either study.

Dr. Sexson Tejtel also noted that the U.S. researchers did not assess outcomes among children treated with steroids alone. “It would be interesting to know what steroids alone look like in the U.S. MIS-C population,” she said in an interview.

BATS corresponding author Michael Levin, MBE, PhD, FRCPCH, an Imperial College professor of pediatrics and international child health, told this news organization that the differing results may have arisen because of the international study’s three-treatment focus, its wider spectrum of patients, and its different endpoints: Death and inotropic support on or after day 2, versus echocardiographic left ventricular dysfunction or inotropic usage.

Regardless of the differences between the two studies, neither establishes the most effective single or combination treatment, writes Roberta L. DeBiasi, MD, of the Division of Pediatric Infectious Diseases at Children’s National Hospital and Research Institute and George Washington University, Washington, in an accompanying editorial. “Specifically, neither study was powered to include an evaluation of approaches that steer away from broad immunosuppression with glucocorticoids and that focus on more targeted and titratable treatments with biologic agents, such as anakinra and infliximab,” she writes.

Dr. DeBiasi adds that long-term follow-up studies of cardiac and noncardiac outcomes in these patients will launch soon. “Meanwhile, continued collaboration across centers is essential to decreasing the short-term incidence of death and complications,” she writes.

“It will be interesting as we apply results from these studies as they come out to see how they change our practice,” Dr. Sexson Tejtel said. “And it would be good to have some randomized clinical trials.”

For Dr. Levin, the bottom line is that all three treatments are associated with recovery for a majority of children. “This is good news for clinicians who have been guessing which treatment to use,” he said. “Both studies are attempts to provide doctors with some evidence on which to base treatment decisions and are not the final answer. Our study is ongoing, and with larger numbers of patients it may give clearer answers.”

The Overcoming COVID-19 study was funded by the U.S. Centers for Disease Control and Prevention. Several coauthors have reported support from industry outside of the submitted work. BATS was funded by the European Union’s Horizons 2020 Program. The study authors have disclosed no relevant financial relationships. One coauthor’s spouse is employed by GlaxoSmithKline. Dr. DeBiasi and Dr. Sexson Tejtel have disclosed no relevant financial relationships.

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

In the absence of formal clinical trials, pediatricians are racing to determine the efficacy and risks of currently used therapies for the SARS-CoV-2–linked multisystem inflammatory syndrome in children (MIS-C).

That requires rapid pragmatic evaluation of therapies. Two real-world observational studies published online June 16 in The New England Journal of Medicine do that, with differing results.

In the Overcoming COVID-19 study, investigators assessed initial therapy and outcomes for patients with MIS-C using surveillance data from 58 pediatric hospitals nationwide.

The results suggest that patients with MIS-C who were younger than 21 years of age and who were initially treated with intravenous immunoglobulin (IVIG) plus glucocorticoids fared better in terms of cardiovascular function.

The study included 518 children (median age, 8.7 years) who were admitted to the hospital between March and October 2020 and who received at least one immunomodulatory therapy. In a propensity score–matched analysis, those given IVIG plus glucocorticoids (n = 103) had a lower risk for the primary outcome of cardiovascular dysfunction on or after day 2 than those given IVIG alone (n = 103), at 17% versus 31% (risk ratio, 0.56; 95% confidence interval, 0.34-0.94).

Risks for individual aspects of the study’s composite outcome were also lower with IVIG plus glucocorticoids. Left ventricular dysfunction occurred in 8% and 17%, respectively (RR, 0.46; 95% CI, 0.19-1.15). Shock requiring vasopressor use emerged in 13% and 24%, respectively (RR, 0.54; 95% CI, 0.29-1.00).

In addition, there were fewer cases in which adjunctive therapy was given on day one among those who received combination therapy than among those who received IVIG alone, at 34% versus 70% (RR, 0.49; 95% CI, 0.36-0.65), but the risk for fever was not lower on or after day two (31% and 40%, respectively; RR, 0.78; 95% CI, 0.53-1.13).

Lead author Mary Beth F. Son, MD, director of the rheumatology program at Boston Children’s Hospital, who is also associate professor of pediatrics at Harvard Medical School, stressed that the study did not assess which MIS-C patients should receive treatment. “Rather, we studied children who had been treated with one of two initial regimens and then assessed short-term outcomes,” she told this news organization.

Going forward, it will be important to study which children should receive immunomodulatory treatment, Dr. Son said. “Specifically, can the less ill children receive IVIG alone or no treatment? This is an unanswered question at the moment, which could be addressed with a randomized controlled trial.”

Future directions, she added, will include assessing long-term cardiac outcomes for patients with MIS-C as well as studying outpatient regimens, especially those that involve steroids.

Earlier this year, French investigators found better outcomes with combined corticosteroids and IVIG than with IVIG alone. They suggested that combination therapy should be the standard of care, given the present state of therapeutic knowledge.
 

Maybe not so standard

Different results emerged, however, from an international study of MIS-C that compared three, rather than two, treatment approaches. Collaborators from the Best Available Treatment Study for MIS-C (BATS) evaluated data for 614 children with suspected MIS-C between June 2020 and February 2021 in 32 countries and found no substantial differences in recovery among children whose primary treatment was IVIG alone, IVIG plus glucocorticoids, or glucocorticoids alone.

The study by Andrew J. McArdle, MB BChir, MSC, a clinical research fellow at Imperial College London, and colleagues was published June 16 in The New England Journal of Medicine.

In the BATS cohort, 246 received IVIG alone, 208 received IVIG plus glucocorticoids, and 99 received glucocorticoids alone. Twenty-two patients received other combinations, including biologics, and 39 received no immunomodulatory therapy.

Among patients who were included in the primary analysis, death occurred or inotropic or ventilatory support was employed in 56 of 180 of the patients who received IVIG plus glucocorticoids, compared with 44 of 211 patients treated with IVIG alone, for an adjusted odds ratio (aOR) of 0.77 (95% CI, 0.33-1.82). Among those who received glucocorticoids alone, 17 of 83 met the primary endpoint of death or inotropic or ventilatory support, for an aOR relative to IVIG alone of 0.54 (95% CI, 0.22-1.33).

After adjustments, the likelihood for reduced disease severity was similar in the two groups relative to IVIG alone, at 0.90 for IVIG plus glucocorticoids and 0.93 for glucocorticoids alone. Time to reduction in disease severity was also comparable across all groups.

Some of the differences between the U.S. study and the global studies could be the result of the larger size of the international cohort and possibly a difference in the strains of virus in the United States and abroad, according to S. Sexson Tejtel, MD, PhD, MPH, a pediatric cardiologist at Texas Children’s Hospital and an assistant professor at Baylor College of Medicine, Houston, Texas. “Some strains make children sicker than others, and they’re going to need more treatment,” said Dr. Sexson Tejtel, who was not involved in either study.

Dr. Sexson Tejtel also noted that the U.S. researchers did not assess outcomes among children treated with steroids alone. “It would be interesting to know what steroids alone look like in the U.S. MIS-C population,” she said in an interview.

BATS corresponding author Michael Levin, MBE, PhD, FRCPCH, an Imperial College professor of pediatrics and international child health, told this news organization that the differing results may have arisen because of the international study’s three-treatment focus, its wider spectrum of patients, and its different endpoints: Death and inotropic support on or after day 2, versus echocardiographic left ventricular dysfunction or inotropic usage.

Regardless of the differences between the two studies, neither establishes the most effective single or combination treatment, writes Roberta L. DeBiasi, MD, of the Division of Pediatric Infectious Diseases at Children’s National Hospital and Research Institute and George Washington University, Washington, in an accompanying editorial. “Specifically, neither study was powered to include an evaluation of approaches that steer away from broad immunosuppression with glucocorticoids and that focus on more targeted and titratable treatments with biologic agents, such as anakinra and infliximab,” she writes.

Dr. DeBiasi adds that long-term follow-up studies of cardiac and noncardiac outcomes in these patients will launch soon. “Meanwhile, continued collaboration across centers is essential to decreasing the short-term incidence of death and complications,” she writes.

“It will be interesting as we apply results from these studies as they come out to see how they change our practice,” Dr. Sexson Tejtel said. “And it would be good to have some randomized clinical trials.”

For Dr. Levin, the bottom line is that all three treatments are associated with recovery for a majority of children. “This is good news for clinicians who have been guessing which treatment to use,” he said. “Both studies are attempts to provide doctors with some evidence on which to base treatment decisions and are not the final answer. Our study is ongoing, and with larger numbers of patients it may give clearer answers.”

The Overcoming COVID-19 study was funded by the U.S. Centers for Disease Control and Prevention. Several coauthors have reported support from industry outside of the submitted work. BATS was funded by the European Union’s Horizons 2020 Program. The study authors have disclosed no relevant financial relationships. One coauthor’s spouse is employed by GlaxoSmithKline. Dr. DeBiasi and Dr. Sexson Tejtel have disclosed no relevant financial relationships.

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

In the absence of formal clinical trials, pediatricians are racing to determine the efficacy and risks of currently used therapies for the SARS-CoV-2–linked multisystem inflammatory syndrome in children (MIS-C).

That requires rapid pragmatic evaluation of therapies. Two real-world observational studies published online June 16 in The New England Journal of Medicine do that, with differing results.

In the Overcoming COVID-19 study, investigators assessed initial therapy and outcomes for patients with MIS-C using surveillance data from 58 pediatric hospitals nationwide.

The results suggest that patients with MIS-C who were younger than 21 years of age and who were initially treated with intravenous immunoglobulin (IVIG) plus glucocorticoids fared better in terms of cardiovascular function.

The study included 518 children (median age, 8.7 years) who were admitted to the hospital between March and October 2020 and who received at least one immunomodulatory therapy. In a propensity score–matched analysis, those given IVIG plus glucocorticoids (n = 103) had a lower risk for the primary outcome of cardiovascular dysfunction on or after day 2 than those given IVIG alone (n = 103), at 17% versus 31% (risk ratio, 0.56; 95% confidence interval, 0.34-0.94).

Risks for individual aspects of the study’s composite outcome were also lower with IVIG plus glucocorticoids. Left ventricular dysfunction occurred in 8% and 17%, respectively (RR, 0.46; 95% CI, 0.19-1.15). Shock requiring vasopressor use emerged in 13% and 24%, respectively (RR, 0.54; 95% CI, 0.29-1.00).

In addition, there were fewer cases in which adjunctive therapy was given on day one among those who received combination therapy than among those who received IVIG alone, at 34% versus 70% (RR, 0.49; 95% CI, 0.36-0.65), but the risk for fever was not lower on or after day two (31% and 40%, respectively; RR, 0.78; 95% CI, 0.53-1.13).

Lead author Mary Beth F. Son, MD, director of the rheumatology program at Boston Children’s Hospital, who is also associate professor of pediatrics at Harvard Medical School, stressed that the study did not assess which MIS-C patients should receive treatment. “Rather, we studied children who had been treated with one of two initial regimens and then assessed short-term outcomes,” she told this news organization.

Going forward, it will be important to study which children should receive immunomodulatory treatment, Dr. Son said. “Specifically, can the less ill children receive IVIG alone or no treatment? This is an unanswered question at the moment, which could be addressed with a randomized controlled trial.”

Future directions, she added, will include assessing long-term cardiac outcomes for patients with MIS-C as well as studying outpatient regimens, especially those that involve steroids.

Earlier this year, French investigators found better outcomes with combined corticosteroids and IVIG than with IVIG alone. They suggested that combination therapy should be the standard of care, given the present state of therapeutic knowledge.
 

Maybe not so standard

Different results emerged, however, from an international study of MIS-C that compared three, rather than two, treatment approaches. Collaborators from the Best Available Treatment Study for MIS-C (BATS) evaluated data for 614 children with suspected MIS-C between June 2020 and February 2021 in 32 countries and found no substantial differences in recovery among children whose primary treatment was IVIG alone, IVIG plus glucocorticoids, or glucocorticoids alone.

The study by Andrew J. McArdle, MB BChir, MSC, a clinical research fellow at Imperial College London, and colleagues was published June 16 in The New England Journal of Medicine.

In the BATS cohort, 246 received IVIG alone, 208 received IVIG plus glucocorticoids, and 99 received glucocorticoids alone. Twenty-two patients received other combinations, including biologics, and 39 received no immunomodulatory therapy.

Among patients who were included in the primary analysis, death occurred or inotropic or ventilatory support was employed in 56 of 180 of the patients who received IVIG plus glucocorticoids, compared with 44 of 211 patients treated with IVIG alone, for an adjusted odds ratio (aOR) of 0.77 (95% CI, 0.33-1.82). Among those who received glucocorticoids alone, 17 of 83 met the primary endpoint of death or inotropic or ventilatory support, for an aOR relative to IVIG alone of 0.54 (95% CI, 0.22-1.33).

After adjustments, the likelihood for reduced disease severity was similar in the two groups relative to IVIG alone, at 0.90 for IVIG plus glucocorticoids and 0.93 for glucocorticoids alone. Time to reduction in disease severity was also comparable across all groups.

Some of the differences between the U.S. study and the global studies could be the result of the larger size of the international cohort and possibly a difference in the strains of virus in the United States and abroad, according to S. Sexson Tejtel, MD, PhD, MPH, a pediatric cardiologist at Texas Children’s Hospital and an assistant professor at Baylor College of Medicine, Houston, Texas. “Some strains make children sicker than others, and they’re going to need more treatment,” said Dr. Sexson Tejtel, who was not involved in either study.

Dr. Sexson Tejtel also noted that the U.S. researchers did not assess outcomes among children treated with steroids alone. “It would be interesting to know what steroids alone look like in the U.S. MIS-C population,” she said in an interview.

BATS corresponding author Michael Levin, MBE, PhD, FRCPCH, an Imperial College professor of pediatrics and international child health, told this news organization that the differing results may have arisen because of the international study’s three-treatment focus, its wider spectrum of patients, and its different endpoints: Death and inotropic support on or after day 2, versus echocardiographic left ventricular dysfunction or inotropic usage.

Regardless of the differences between the two studies, neither establishes the most effective single or combination treatment, writes Roberta L. DeBiasi, MD, of the Division of Pediatric Infectious Diseases at Children’s National Hospital and Research Institute and George Washington University, Washington, in an accompanying editorial. “Specifically, neither study was powered to include an evaluation of approaches that steer away from broad immunosuppression with glucocorticoids and that focus on more targeted and titratable treatments with biologic agents, such as anakinra and infliximab,” she writes.

Dr. DeBiasi adds that long-term follow-up studies of cardiac and noncardiac outcomes in these patients will launch soon. “Meanwhile, continued collaboration across centers is essential to decreasing the short-term incidence of death and complications,” she writes.

“It will be interesting as we apply results from these studies as they come out to see how they change our practice,” Dr. Sexson Tejtel said. “And it would be good to have some randomized clinical trials.”

For Dr. Levin, the bottom line is that all three treatments are associated with recovery for a majority of children. “This is good news for clinicians who have been guessing which treatment to use,” he said. “Both studies are attempts to provide doctors with some evidence on which to base treatment decisions and are not the final answer. Our study is ongoing, and with larger numbers of patients it may give clearer answers.”

The Overcoming COVID-19 study was funded by the U.S. Centers for Disease Control and Prevention. Several coauthors have reported support from industry outside of the submitted work. BATS was funded by the European Union’s Horizons 2020 Program. The study authors have disclosed no relevant financial relationships. One coauthor’s spouse is employed by GlaxoSmithKline. Dr. DeBiasi and Dr. Sexson Tejtel have disclosed no relevant financial relationships.

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

Public health precautions meant to reduce the spread of COVID-19 may have had an unintended but happy side effect.

They may also have benefited individuals who have chronic obstructive pulmonary disease (COPD), according to a new study.

During the pandemic, admissions for COPD flare-ups dropped dramatically – by 53% – at University of Maryland Medical System hospitals.

Researchers at the university suspect this was the result of a drop in circulating seasonal respiratory viruses, such as influenza. They theorized that stay-at-home orders, social distancing, mask mandates, and strict limits on large gatherings reduced exposure not only to COVID but also to other respiratory infections.

“Our study shows there’s a silver lining to the behavior changes beyond protecting against COVID-19,” said senior author Robert Reed, MD, a pulmonologist and professor of medicine.

COPD is a group of lung diseases that worsen over time and make it hard to breathe. Before the pandemic, they were the fourth-leading cause of death worldwide, commonly triggered by tobacco smoke and dirty air. Nearly half of flare-ups are caused by seasonal respiratory viruses.

For the study, the researchers analyzed data from 13 UMMS hospitals, comparing weekly admissions for COPD in 2018 and 2019, with admissions after April 1, 2020, when COVID-19 public health measures were introduced. Investigators chose the same six-month period in each year for comparison – April 1 to Sept. 30.

The findings were matched against U.S. federal data on respiratory viral trends between Jan. 1, 2018, and Oct. 1, 2020.

As significant as was the system’s 53% drop in COPD admissions during the pandemic, there was also a 36% decline in weekly admissions for such serious conditions as congestive heart failure, diabetes and heart attack, said co–lead author Jennifer So, MD. She’s an assistant professor of medicine and COPD specialist.

The researchers warned that a full return to normal may again expose COPD patients to the familiar seasonal triggers.

“If we completely eliminate masks and distancing during cold and flu season, we’ll allow all those viruses that have been effectively suppressed to come raging back,” Dr. Reed said in a university news release. “There could be a lot of illness.”

He noted that the study did not assess which measures tamed seasonal viruses. But, Dr. Reed added, “a simple thing like wearing a mask while riding on public transit or working from home when you’re sick with a cold could go a long way to reduce virus exposure.”

Dr. So said it is a cultural norm in her native South Korea to wear masks during the winter.

“The COVID-19 pandemic has helped a lot of people around the world become more aware of the role of masking and social distancing to reduce the spread of disease,” she said in the release.

The findings were recently published in the preprint server medRxiv and have not yet been peer reviewed.

The U.S. Centers for Disease Control and Prevention has more information on COVID-19 and chronic lung diseases.

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

Public health precautions meant to reduce the spread of COVID-19 may have had an unintended but happy side effect.

They may also have benefited individuals who have chronic obstructive pulmonary disease (COPD), according to a new study.

During the pandemic, admissions for COPD flare-ups dropped dramatically – by 53% – at University of Maryland Medical System hospitals.

Researchers at the university suspect this was the result of a drop in circulating seasonal respiratory viruses, such as influenza. They theorized that stay-at-home orders, social distancing, mask mandates, and strict limits on large gatherings reduced exposure not only to COVID but also to other respiratory infections.

“Our study shows there’s a silver lining to the behavior changes beyond protecting against COVID-19,” said senior author Robert Reed, MD, a pulmonologist and professor of medicine.

COPD is a group of lung diseases that worsen over time and make it hard to breathe. Before the pandemic, they were the fourth-leading cause of death worldwide, commonly triggered by tobacco smoke and dirty air. Nearly half of flare-ups are caused by seasonal respiratory viruses.

For the study, the researchers analyzed data from 13 UMMS hospitals, comparing weekly admissions for COPD in 2018 and 2019, with admissions after April 1, 2020, when COVID-19 public health measures were introduced. Investigators chose the same six-month period in each year for comparison – April 1 to Sept. 30.

The findings were matched against U.S. federal data on respiratory viral trends between Jan. 1, 2018, and Oct. 1, 2020.

As significant as was the system’s 53% drop in COPD admissions during the pandemic, there was also a 36% decline in weekly admissions for such serious conditions as congestive heart failure, diabetes and heart attack, said co–lead author Jennifer So, MD. She’s an assistant professor of medicine and COPD specialist.

The researchers warned that a full return to normal may again expose COPD patients to the familiar seasonal triggers.

“If we completely eliminate masks and distancing during cold and flu season, we’ll allow all those viruses that have been effectively suppressed to come raging back,” Dr. Reed said in a university news release. “There could be a lot of illness.”

He noted that the study did not assess which measures tamed seasonal viruses. But, Dr. Reed added, “a simple thing like wearing a mask while riding on public transit or working from home when you’re sick with a cold could go a long way to reduce virus exposure.”

Dr. So said it is a cultural norm in her native South Korea to wear masks during the winter.

“The COVID-19 pandemic has helped a lot of people around the world become more aware of the role of masking and social distancing to reduce the spread of disease,” she said in the release.

The findings were recently published in the preprint server medRxiv and have not yet been peer reviewed.

The U.S. Centers for Disease Control and Prevention has more information on COVID-19 and chronic lung diseases.

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

Public health precautions meant to reduce the spread of COVID-19 may have had an unintended but happy side effect.

They may also have benefited individuals who have chronic obstructive pulmonary disease (COPD), according to a new study.

During the pandemic, admissions for COPD flare-ups dropped dramatically – by 53% – at University of Maryland Medical System hospitals.

Researchers at the university suspect this was the result of a drop in circulating seasonal respiratory viruses, such as influenza. They theorized that stay-at-home orders, social distancing, mask mandates, and strict limits on large gatherings reduced exposure not only to COVID but also to other respiratory infections.

“Our study shows there’s a silver lining to the behavior changes beyond protecting against COVID-19,” said senior author Robert Reed, MD, a pulmonologist and professor of medicine.

COPD is a group of lung diseases that worsen over time and make it hard to breathe. Before the pandemic, they were the fourth-leading cause of death worldwide, commonly triggered by tobacco smoke and dirty air. Nearly half of flare-ups are caused by seasonal respiratory viruses.

For the study, the researchers analyzed data from 13 UMMS hospitals, comparing weekly admissions for COPD in 2018 and 2019, with admissions after April 1, 2020, when COVID-19 public health measures were introduced. Investigators chose the same six-month period in each year for comparison – April 1 to Sept. 30.

The findings were matched against U.S. federal data on respiratory viral trends between Jan. 1, 2018, and Oct. 1, 2020.

As significant as was the system’s 53% drop in COPD admissions during the pandemic, there was also a 36% decline in weekly admissions for such serious conditions as congestive heart failure, diabetes and heart attack, said co–lead author Jennifer So, MD. She’s an assistant professor of medicine and COPD specialist.

The researchers warned that a full return to normal may again expose COPD patients to the familiar seasonal triggers.

“If we completely eliminate masks and distancing during cold and flu season, we’ll allow all those viruses that have been effectively suppressed to come raging back,” Dr. Reed said in a university news release. “There could be a lot of illness.”

He noted that the study did not assess which measures tamed seasonal viruses. But, Dr. Reed added, “a simple thing like wearing a mask while riding on public transit or working from home when you’re sick with a cold could go a long way to reduce virus exposure.”

Dr. So said it is a cultural norm in her native South Korea to wear masks during the winter.

“The COVID-19 pandemic has helped a lot of people around the world become more aware of the role of masking and social distancing to reduce the spread of disease,” she said in the release.

The findings were recently published in the preprint server medRxiv and have not yet been peer reviewed.

The U.S. Centers for Disease Control and Prevention has more information on COVID-19 and chronic lung diseases.

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

Giving a COVID-19 vaccine at the same time as a seasonal flu vaccine appears safe and effective in the first study to test how people react to getting both shots at the same time.

Overall, the NVX-CoV2373 vaccine (Novavax) is showing 89.8% efficacy in an ongoing, placebo-controlled phase 3 study. When the researchers gave a smaller group of 431 volunteers from the same study an influenza shot at the same time, efficacy dropped slightly to 87.5%.

“These results demonstrate the promising opportunity for concomitant vaccination, which may lead to higher vaccination rates and further protection against both viruses,” said study coauthor Raja Rajaram, MD, medical affairs lead, Europe, Middle East, and Africa at Seqirus, the company that supplied the influenza vaccines for the research.

The research was published online June 13 as a medRxiv preprint.

“With these COVID-19 vaccines, there are essentially no concurrent use studies,” Paul A. Offit, MD, told this news organization when asked to comment.

Traditionally, how a new vaccine might interact with existing vaccines is studied before the product is cleared for use. That was not the case, however, with the COVID-19 vaccines made available through expedited emergency use authorization.

The researchers found no major safety concerns associated with concomitant vaccination, Dr. Rajaram said. In addition to safety, the aim of the current study was to determine whether either vaccine changes the immunogenicity or effectiveness of the other.

“It’s a small study, but it’s certainly encouraging to know that there didn’t seem to be a big decrease in immunogenicity either way and the safety profile was similar. Not identical, but similar,” added Dr. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Some adverse events were more common in the co-administration group. For example, injection-site tenderness was reported by 70%, versus 58% for those who got the COVID-19 shot alone. The same was true for pain at the injection site, 40% versus 29%; fatigue, 28% versus 19%; and muscle pain, 28% versus 21%.

Rates of unsolicited adverse events, adverse events that required medical attention, and serious adverse events were low and well balanced between groups.
 

Fewer antibodies important?

Although co-administering the two vaccines did not change the immune response for the influenza vaccine, the spike protein antibody response to the COVID-19 vaccine was less robust.

Antibody titer levels at day 35 were 46,678 among people in the Novavax vaccine alone group, compared with 31,236 titers in the participants who received both vaccines.

“This impact did not seem to be clinically meaningful as vaccine efficacy appeared to be preserved,” the researchers noted.

Gregory A. Poland, MD, an internist and part of the Vaccine Research Group at Mayo Clinic in Rochester, Minn., agreed. “I highly doubt that is significant,” he said in an interview.

Dr. Rajaram said the antibody findings are “slightly surprising but not completely unexpected” because the same observation has been made in other combination vaccine studies. He added that the antibody levels “remain very high, although we do not yet know what antibody levels are required to achieve protection against COVID-19.”

The decrease could become more concerning if people start with fewer antibodies and they drop over time with normal waning of protection, Dr. Poland said. This group could include people over age 65 or people who are immunocompromised. More data would be needed to confirm this, he added.
 

A boost for booster vaccines?

The research could carry implications for future COVID-19 booster shots, Dr. Poland said.

“Overall, the study results are reassuring and of potential practical importance if we have to give booster doses. It will make it easier to give them both in one visit,” said Dr. Poland, who was not affiliated with the research.

Although Novavax could be positioning itself as a logical choice for a COVID-19 booster based on the findings, Dr. Offit believes it is more important to focus on having more COVID-19 vaccine options available.

“There may be, as we say at the track, ‘courses for horses,’ ” he said, meaning that different vaccines may be better suited for different situations.

“It’s likely we’re going to find these vaccines have different safety profiles, they may have different populations for whom they work best, and they may have differences in terms of their long-term durability,” he added. Also, some may prove more effective against certain variants of concern.

The Novavax vaccine would add a new class of COVID-19 vaccine to the mRNA and adenovirus vaccines. NVX-CoV2373 is a recombinant spike protein vaccine.

“I think the more vaccines that are available here, the better,” Dr. Offit said.
 

Study limitations

Dr. Poland shared some caveats. The study was primarily conducted in adults aged 18-64 years, so there is less certainty on what could happen in people over 65. Furthermore, co-administration was evaluated after the first dose of the Novavax vaccine. “The reason I bring that up is most of the COVID-19 vaccine reactogenicity occurs with dose two, not dose one.

“All in all, it’s an important first step – but it’s only a first step,” Dr. Poland said. “We need more data, including in elderly people who are primarily at risk for morbidity and mortality from the flu.”

He suggested expanding the research to study co-administration of COVID-19 vaccines with different formulations of influenza vaccines.

The study was supported by Novavax. Dr. Offit had no relevant financial disclosures. Dr. Poland serves as a consultant to all of the COVID-19 vaccine companies.

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

Giving a COVID-19 vaccine at the same time as a seasonal flu vaccine appears safe and effective in the first study to test how people react to getting both shots at the same time.

Overall, the NVX-CoV2373 vaccine (Novavax) is showing 89.8% efficacy in an ongoing, placebo-controlled phase 3 study. When the researchers gave a smaller group of 431 volunteers from the same study an influenza shot at the same time, efficacy dropped slightly to 87.5%.

“These results demonstrate the promising opportunity for concomitant vaccination, which may lead to higher vaccination rates and further protection against both viruses,” said study coauthor Raja Rajaram, MD, medical affairs lead, Europe, Middle East, and Africa at Seqirus, the company that supplied the influenza vaccines for the research.

The research was published online June 13 as a medRxiv preprint.

“With these COVID-19 vaccines, there are essentially no concurrent use studies,” Paul A. Offit, MD, told this news organization when asked to comment.

Traditionally, how a new vaccine might interact with existing vaccines is studied before the product is cleared for use. That was not the case, however, with the COVID-19 vaccines made available through expedited emergency use authorization.

The researchers found no major safety concerns associated with concomitant vaccination, Dr. Rajaram said. In addition to safety, the aim of the current study was to determine whether either vaccine changes the immunogenicity or effectiveness of the other.

“It’s a small study, but it’s certainly encouraging to know that there didn’t seem to be a big decrease in immunogenicity either way and the safety profile was similar. Not identical, but similar,” added Dr. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Some adverse events were more common in the co-administration group. For example, injection-site tenderness was reported by 70%, versus 58% for those who got the COVID-19 shot alone. The same was true for pain at the injection site, 40% versus 29%; fatigue, 28% versus 19%; and muscle pain, 28% versus 21%.

Rates of unsolicited adverse events, adverse events that required medical attention, and serious adverse events were low and well balanced between groups.
 

Fewer antibodies important?

Although co-administering the two vaccines did not change the immune response for the influenza vaccine, the spike protein antibody response to the COVID-19 vaccine was less robust.

Antibody titer levels at day 35 were 46,678 among people in the Novavax vaccine alone group, compared with 31,236 titers in the participants who received both vaccines.

“This impact did not seem to be clinically meaningful as vaccine efficacy appeared to be preserved,” the researchers noted.

Gregory A. Poland, MD, an internist and part of the Vaccine Research Group at Mayo Clinic in Rochester, Minn., agreed. “I highly doubt that is significant,” he said in an interview.

Dr. Rajaram said the antibody findings are “slightly surprising but not completely unexpected” because the same observation has been made in other combination vaccine studies. He added that the antibody levels “remain very high, although we do not yet know what antibody levels are required to achieve protection against COVID-19.”

The decrease could become more concerning if people start with fewer antibodies and they drop over time with normal waning of protection, Dr. Poland said. This group could include people over age 65 or people who are immunocompromised. More data would be needed to confirm this, he added.
 

A boost for booster vaccines?

The research could carry implications for future COVID-19 booster shots, Dr. Poland said.

“Overall, the study results are reassuring and of potential practical importance if we have to give booster doses. It will make it easier to give them both in one visit,” said Dr. Poland, who was not affiliated with the research.

Although Novavax could be positioning itself as a logical choice for a COVID-19 booster based on the findings, Dr. Offit believes it is more important to focus on having more COVID-19 vaccine options available.

“There may be, as we say at the track, ‘courses for horses,’ ” he said, meaning that different vaccines may be better suited for different situations.

“It’s likely we’re going to find these vaccines have different safety profiles, they may have different populations for whom they work best, and they may have differences in terms of their long-term durability,” he added. Also, some may prove more effective against certain variants of concern.

The Novavax vaccine would add a new class of COVID-19 vaccine to the mRNA and adenovirus vaccines. NVX-CoV2373 is a recombinant spike protein vaccine.

“I think the more vaccines that are available here, the better,” Dr. Offit said.
 

Study limitations

Dr. Poland shared some caveats. The study was primarily conducted in adults aged 18-64 years, so there is less certainty on what could happen in people over 65. Furthermore, co-administration was evaluated after the first dose of the Novavax vaccine. “The reason I bring that up is most of the COVID-19 vaccine reactogenicity occurs with dose two, not dose one.

“All in all, it’s an important first step – but it’s only a first step,” Dr. Poland said. “We need more data, including in elderly people who are primarily at risk for morbidity and mortality from the flu.”

He suggested expanding the research to study co-administration of COVID-19 vaccines with different formulations of influenza vaccines.

The study was supported by Novavax. Dr. Offit had no relevant financial disclosures. Dr. Poland serves as a consultant to all of the COVID-19 vaccine companies.

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

Giving a COVID-19 vaccine at the same time as a seasonal flu vaccine appears safe and effective in the first study to test how people react to getting both shots at the same time.

Overall, the NVX-CoV2373 vaccine (Novavax) is showing 89.8% efficacy in an ongoing, placebo-controlled phase 3 study. When the researchers gave a smaller group of 431 volunteers from the same study an influenza shot at the same time, efficacy dropped slightly to 87.5%.

“These results demonstrate the promising opportunity for concomitant vaccination, which may lead to higher vaccination rates and further protection against both viruses,” said study coauthor Raja Rajaram, MD, medical affairs lead, Europe, Middle East, and Africa at Seqirus, the company that supplied the influenza vaccines for the research.

The research was published online June 13 as a medRxiv preprint.

“With these COVID-19 vaccines, there are essentially no concurrent use studies,” Paul A. Offit, MD, told this news organization when asked to comment.

Traditionally, how a new vaccine might interact with existing vaccines is studied before the product is cleared for use. That was not the case, however, with the COVID-19 vaccines made available through expedited emergency use authorization.

The researchers found no major safety concerns associated with concomitant vaccination, Dr. Rajaram said. In addition to safety, the aim of the current study was to determine whether either vaccine changes the immunogenicity or effectiveness of the other.

“It’s a small study, but it’s certainly encouraging to know that there didn’t seem to be a big decrease in immunogenicity either way and the safety profile was similar. Not identical, but similar,” added Dr. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Some adverse events were more common in the co-administration group. For example, injection-site tenderness was reported by 70%, versus 58% for those who got the COVID-19 shot alone. The same was true for pain at the injection site, 40% versus 29%; fatigue, 28% versus 19%; and muscle pain, 28% versus 21%.

Rates of unsolicited adverse events, adverse events that required medical attention, and serious adverse events were low and well balanced between groups.
 

Fewer antibodies important?

Although co-administering the two vaccines did not change the immune response for the influenza vaccine, the spike protein antibody response to the COVID-19 vaccine was less robust.

Antibody titer levels at day 35 were 46,678 among people in the Novavax vaccine alone group, compared with 31,236 titers in the participants who received both vaccines.

“This impact did not seem to be clinically meaningful as vaccine efficacy appeared to be preserved,” the researchers noted.

Gregory A. Poland, MD, an internist and part of the Vaccine Research Group at Mayo Clinic in Rochester, Minn., agreed. “I highly doubt that is significant,” he said in an interview.

Dr. Rajaram said the antibody findings are “slightly surprising but not completely unexpected” because the same observation has been made in other combination vaccine studies. He added that the antibody levels “remain very high, although we do not yet know what antibody levels are required to achieve protection against COVID-19.”

The decrease could become more concerning if people start with fewer antibodies and they drop over time with normal waning of protection, Dr. Poland said. This group could include people over age 65 or people who are immunocompromised. More data would be needed to confirm this, he added.
 

A boost for booster vaccines?

The research could carry implications for future COVID-19 booster shots, Dr. Poland said.

“Overall, the study results are reassuring and of potential practical importance if we have to give booster doses. It will make it easier to give them both in one visit,” said Dr. Poland, who was not affiliated with the research.

Although Novavax could be positioning itself as a logical choice for a COVID-19 booster based on the findings, Dr. Offit believes it is more important to focus on having more COVID-19 vaccine options available.

“There may be, as we say at the track, ‘courses for horses,’ ” he said, meaning that different vaccines may be better suited for different situations.

“It’s likely we’re going to find these vaccines have different safety profiles, they may have different populations for whom they work best, and they may have differences in terms of their long-term durability,” he added. Also, some may prove more effective against certain variants of concern.

The Novavax vaccine would add a new class of COVID-19 vaccine to the mRNA and adenovirus vaccines. NVX-CoV2373 is a recombinant spike protein vaccine.

“I think the more vaccines that are available here, the better,” Dr. Offit said.
 

Study limitations

Dr. Poland shared some caveats. The study was primarily conducted in adults aged 18-64 years, so there is less certainty on what could happen in people over 65. Furthermore, co-administration was evaluated after the first dose of the Novavax vaccine. “The reason I bring that up is most of the COVID-19 vaccine reactogenicity occurs with dose two, not dose one.

“All in all, it’s an important first step – but it’s only a first step,” Dr. Poland said. “We need more data, including in elderly people who are primarily at risk for morbidity and mortality from the flu.”

He suggested expanding the research to study co-administration of COVID-19 vaccines with different formulations of influenza vaccines.

The study was supported by Novavax. Dr. Offit had no relevant financial disclosures. Dr. Poland serves as a consultant to all of the COVID-19 vaccine companies.

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

Agents that reverse the effect of direct oral anticoagulants (DOACs) are highly effective in patients with severe bleeding, but mortality rates remain high despite their use, a meta-analysis shows.

Effective hemostasis was achieved in 78.5% of patients treated with a reversal agent, whereas failure to achieve hemostasis was associated with more than a threefold higher relative risk for death (relative risk, 3.63; 95% confidence interval, 2.56-5.16).

“This has implications in practice because it emphasizes the need for achieving effective hemostasis, if not with only one agent, trying other agents or treatment modalities, because it is a strong predictor of survival,” lead author Antonio Gómez-Outes, MD, PhD, said in an interview.

The bad news, he said, is that the mortality rate was still significant, at 17.7%, and approximately half of patients with DOAC-related severe intracranial bleeding survived with long-term moderate/severe disability.

“The lesson is to prevent these bleeding events because once they appear, even if you give an antidote, the outcome is poor, particularly for intracranial bleeding,” said Dr. Gómez-Outes, division of pharmacology and clinical drug evaluation, Spanish Agency for Medicines and Medical Devices, Madrid.

To put this in context, mortality rates were close to 50% after intracranial bleeding a decade ago when there were no antidotes or reversal agents, he observed. “So to some extent, patient care has improved, and the outcome has improved, but there is a long road to improve regarding disability.”

More than 100,000 DOAC-related major bleeding cases occur each year in the United States and European Union, Dr. Gómez-Outes said, and about half are severe enough to require hospitalization and potentially the use of a reversal agent. These include idarucizumab (Praxbind) for dabigatran reversal and prothombin complex concentrates (4CCC) or andexanet alpha (Andexxa) for reversal of direct factor Xa inhibitors like rivaroxaban, apixaban, and edoxaban.

As reported in the June 22 issue of the Journal of the American College of Cardiology, the meta-analysis comprised 4,735 patients (mean age, 77 years; 57% male) with severe DOAC-related bleeding who received 4PCC (n = 2,688), idarucizumab (n = 1,111), or andexanet (n = 936) in 60 studies between January 2010 and December 2020.

Atrial fibrillation (AFib) was the most common reason for use of a DOAC (82%), followed by venous thromboembolism (14%). Rivaroxaban was used in 36%, apixaban in 32%, dabigatran in 31%, and edoxaban in 1%.

The index bleeding event was intracranial hemorrhage (ICH) in 55%. Anticoagulation was restarted in 57% of patients an average of 11 days after admission.

Mortality rates were 20.2% in patients with ICH and 15.4% in those with extracranial bleeding. There were no differences in death rates by reversal agent used, type of study, risk for bias, or study sponsorship in meta-regression analysis.

Rebleeding occurred in 13.2% of patients; 82.0% of these events were described as an ICH, and 78.0% occurred after anticoagulation was restarted.

The overall rate of thromboembolism was 4.6%. The risk was particularly high with andexanet, at 10.7%, and relatively low with idarucizumab (3.8%) and 4PCC (4.3%), the authors note.

“Our meta-analysis suggests specific reversal with andexanet is not superior to unspecific reversal with 4PCC, and that’s good news because many centers, in many countries, have no access to specific antidotes that are more costly,” Dr. Gómez-Outes said. “4PCC is an effective and relatively safe drug, so it’s still a good option for these patients.”

Labeling for andexanet includes a warning for thromboembolic events, but in the absence of direct comparisons, the findings should be interpreted with caution, he added. Further insights are expected from an ongoing randomized trial of andexanet and standard of care in 900 patients who present with acute ICH less than 15 hours after taking an oral factor Xa inhibitor. The preliminary completion date is set for 2023.

“The meta-analysis raises awareness about the rates of mortality and thromboembolism after reversal agent administration, although understanding the implications of these data is challenging,” Christopher Granger, MD, and Sean P. Pokomey, MD, MBA, Duke University Medical Center, Durham, N.C., say in an accompanying editorial.

The fact that failure to achieve hemostasis was associated with death is expected and might be related to the way hemostasis was defined, rather than the actual failure of the hemostatic treatments, they suggest. “The prothrombotic effects of each agent, including andexanet, need to be better understood, as clinicians work toward including reversal agents into algorithms for bleeding management.”

Effective hemostasis was defined in the studies through various methods as: “Excellent/good” using the Sarode and ANNEXA-4 scales; “yes” in the International Society on Thrombosis and Hemostasis Scale; and with other scales and through clinical judgment.

Although the size of the meta-analysis dwarfs previous reviews, the editorialists and authors point out that 47 of the 60 studies were retrospective, only two had control groups, and 45 had a high risk for bias.

In general, there was also poor reporting of key clinical data, such as postbleeding anticoagulation management, and a limitation of the mortality analysis is that it was based in selected patients with effective hemostasis assessed within 48 hours, which may not capture early deaths, the authors note.

“The morbidity and mortality from ischemic strokes as a result of undertreatment of stroke prevention in patients with AFib continue to dwarf the bleeding related mortality among patients with AFib and on DOACs, and thus the number one priority is to treat nearly all patients with AFib with a DOAC,” Dr. Granger and Dr. Pokomey conclude. “The availability of reversal agents for DOACs should provide reassurance, with another tool in our armamentarium, to providers to prescribe OACs for stroke prevention.”

No funding/grant support was received to conduct the study. Coauthor Ramón Lecumberri has received personal fees from Boehringer Ingelheim and Bristol Myers Squibb outside the submitted work. All other authors report no relevant financial relationships. Dr. Granger has received research and consulting fees from Bristol Myers Squibb, Pfizer, Boehringer Ingelheim, Bayer, Janssen, Boston Scientific, Apple, AstraZeneca, Novartis, AbbVie, Biomed, CeleCor, GSK, Novartis, Medtronic, Merck, Novo Nordisk, Philips, Rho, and the U.S. Food and Drug Administration. Dr. Pokomey has received modest consulting support from Bristol Myers Squibb, Pfizer, Boston Scientific, Medtronic, Janssen, and Zoll; modest research support from Gilead, Boston Scientific, Bristol Myers Squibb, Pfizer, and Janssen; and significant research support from the FDA.

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

Agents that reverse the effect of direct oral anticoagulants (DOACs) are highly effective in patients with severe bleeding, but mortality rates remain high despite their use, a meta-analysis shows.

Effective hemostasis was achieved in 78.5% of patients treated with a reversal agent, whereas failure to achieve hemostasis was associated with more than a threefold higher relative risk for death (relative risk, 3.63; 95% confidence interval, 2.56-5.16).

“This has implications in practice because it emphasizes the need for achieving effective hemostasis, if not with only one agent, trying other agents or treatment modalities, because it is a strong predictor of survival,” lead author Antonio Gómez-Outes, MD, PhD, said in an interview.

The bad news, he said, is that the mortality rate was still significant, at 17.7%, and approximately half of patients with DOAC-related severe intracranial bleeding survived with long-term moderate/severe disability.

“The lesson is to prevent these bleeding events because once they appear, even if you give an antidote, the outcome is poor, particularly for intracranial bleeding,” said Dr. Gómez-Outes, division of pharmacology and clinical drug evaluation, Spanish Agency for Medicines and Medical Devices, Madrid.

To put this in context, mortality rates were close to 50% after intracranial bleeding a decade ago when there were no antidotes or reversal agents, he observed. “So to some extent, patient care has improved, and the outcome has improved, but there is a long road to improve regarding disability.”

More than 100,000 DOAC-related major bleeding cases occur each year in the United States and European Union, Dr. Gómez-Outes said, and about half are severe enough to require hospitalization and potentially the use of a reversal agent. These include idarucizumab (Praxbind) for dabigatran reversal and prothombin complex concentrates (4CCC) or andexanet alpha (Andexxa) for reversal of direct factor Xa inhibitors like rivaroxaban, apixaban, and edoxaban.

As reported in the June 22 issue of the Journal of the American College of Cardiology, the meta-analysis comprised 4,735 patients (mean age, 77 years; 57% male) with severe DOAC-related bleeding who received 4PCC (n = 2,688), idarucizumab (n = 1,111), or andexanet (n = 936) in 60 studies between January 2010 and December 2020.

Atrial fibrillation (AFib) was the most common reason for use of a DOAC (82%), followed by venous thromboembolism (14%). Rivaroxaban was used in 36%, apixaban in 32%, dabigatran in 31%, and edoxaban in 1%.

The index bleeding event was intracranial hemorrhage (ICH) in 55%. Anticoagulation was restarted in 57% of patients an average of 11 days after admission.

Mortality rates were 20.2% in patients with ICH and 15.4% in those with extracranial bleeding. There were no differences in death rates by reversal agent used, type of study, risk for bias, or study sponsorship in meta-regression analysis.

Rebleeding occurred in 13.2% of patients; 82.0% of these events were described as an ICH, and 78.0% occurred after anticoagulation was restarted.

The overall rate of thromboembolism was 4.6%. The risk was particularly high with andexanet, at 10.7%, and relatively low with idarucizumab (3.8%) and 4PCC (4.3%), the authors note.

“Our meta-analysis suggests specific reversal with andexanet is not superior to unspecific reversal with 4PCC, and that’s good news because many centers, in many countries, have no access to specific antidotes that are more costly,” Dr. Gómez-Outes said. “4PCC is an effective and relatively safe drug, so it’s still a good option for these patients.”

Labeling for andexanet includes a warning for thromboembolic events, but in the absence of direct comparisons, the findings should be interpreted with caution, he added. Further insights are expected from an ongoing randomized trial of andexanet and standard of care in 900 patients who present with acute ICH less than 15 hours after taking an oral factor Xa inhibitor. The preliminary completion date is set for 2023.

“The meta-analysis raises awareness about the rates of mortality and thromboembolism after reversal agent administration, although understanding the implications of these data is challenging,” Christopher Granger, MD, and Sean P. Pokomey, MD, MBA, Duke University Medical Center, Durham, N.C., say in an accompanying editorial.

The fact that failure to achieve hemostasis was associated with death is expected and might be related to the way hemostasis was defined, rather than the actual failure of the hemostatic treatments, they suggest. “The prothrombotic effects of each agent, including andexanet, need to be better understood, as clinicians work toward including reversal agents into algorithms for bleeding management.”

Effective hemostasis was defined in the studies through various methods as: “Excellent/good” using the Sarode and ANNEXA-4 scales; “yes” in the International Society on Thrombosis and Hemostasis Scale; and with other scales and through clinical judgment.

Although the size of the meta-analysis dwarfs previous reviews, the editorialists and authors point out that 47 of the 60 studies were retrospective, only two had control groups, and 45 had a high risk for bias.

In general, there was also poor reporting of key clinical data, such as postbleeding anticoagulation management, and a limitation of the mortality analysis is that it was based in selected patients with effective hemostasis assessed within 48 hours, which may not capture early deaths, the authors note.

“The morbidity and mortality from ischemic strokes as a result of undertreatment of stroke prevention in patients with AFib continue to dwarf the bleeding related mortality among patients with AFib and on DOACs, and thus the number one priority is to treat nearly all patients with AFib with a DOAC,” Dr. Granger and Dr. Pokomey conclude. “The availability of reversal agents for DOACs should provide reassurance, with another tool in our armamentarium, to providers to prescribe OACs for stroke prevention.”

No funding/grant support was received to conduct the study. Coauthor Ramón Lecumberri has received personal fees from Boehringer Ingelheim and Bristol Myers Squibb outside the submitted work. All other authors report no relevant financial relationships. Dr. Granger has received research and consulting fees from Bristol Myers Squibb, Pfizer, Boehringer Ingelheim, Bayer, Janssen, Boston Scientific, Apple, AstraZeneca, Novartis, AbbVie, Biomed, CeleCor, GSK, Novartis, Medtronic, Merck, Novo Nordisk, Philips, Rho, and the U.S. Food and Drug Administration. Dr. Pokomey has received modest consulting support from Bristol Myers Squibb, Pfizer, Boston Scientific, Medtronic, Janssen, and Zoll; modest research support from Gilead, Boston Scientific, Bristol Myers Squibb, Pfizer, and Janssen; and significant research support from the FDA.

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

Agents that reverse the effect of direct oral anticoagulants (DOACs) are highly effective in patients with severe bleeding, but mortality rates remain high despite their use, a meta-analysis shows.

Effective hemostasis was achieved in 78.5% of patients treated with a reversal agent, whereas failure to achieve hemostasis was associated with more than a threefold higher relative risk for death (relative risk, 3.63; 95% confidence interval, 2.56-5.16).

“This has implications in practice because it emphasizes the need for achieving effective hemostasis, if not with only one agent, trying other agents or treatment modalities, because it is a strong predictor of survival,” lead author Antonio Gómez-Outes, MD, PhD, said in an interview.

The bad news, he said, is that the mortality rate was still significant, at 17.7%, and approximately half of patients with DOAC-related severe intracranial bleeding survived with long-term moderate/severe disability.

“The lesson is to prevent these bleeding events because once they appear, even if you give an antidote, the outcome is poor, particularly for intracranial bleeding,” said Dr. Gómez-Outes, division of pharmacology and clinical drug evaluation, Spanish Agency for Medicines and Medical Devices, Madrid.

To put this in context, mortality rates were close to 50% after intracranial bleeding a decade ago when there were no antidotes or reversal agents, he observed. “So to some extent, patient care has improved, and the outcome has improved, but there is a long road to improve regarding disability.”

More than 100,000 DOAC-related major bleeding cases occur each year in the United States and European Union, Dr. Gómez-Outes said, and about half are severe enough to require hospitalization and potentially the use of a reversal agent. These include idarucizumab (Praxbind) for dabigatran reversal and prothombin complex concentrates (4CCC) or andexanet alpha (Andexxa) for reversal of direct factor Xa inhibitors like rivaroxaban, apixaban, and edoxaban.

As reported in the June 22 issue of the Journal of the American College of Cardiology, the meta-analysis comprised 4,735 patients (mean age, 77 years; 57% male) with severe DOAC-related bleeding who received 4PCC (n = 2,688), idarucizumab (n = 1,111), or andexanet (n = 936) in 60 studies between January 2010 and December 2020.

Atrial fibrillation (AFib) was the most common reason for use of a DOAC (82%), followed by venous thromboembolism (14%). Rivaroxaban was used in 36%, apixaban in 32%, dabigatran in 31%, and edoxaban in 1%.

The index bleeding event was intracranial hemorrhage (ICH) in 55%. Anticoagulation was restarted in 57% of patients an average of 11 days after admission.

Mortality rates were 20.2% in patients with ICH and 15.4% in those with extracranial bleeding. There were no differences in death rates by reversal agent used, type of study, risk for bias, or study sponsorship in meta-regression analysis.

Rebleeding occurred in 13.2% of patients; 82.0% of these events were described as an ICH, and 78.0% occurred after anticoagulation was restarted.

The overall rate of thromboembolism was 4.6%. The risk was particularly high with andexanet, at 10.7%, and relatively low with idarucizumab (3.8%) and 4PCC (4.3%), the authors note.

“Our meta-analysis suggests specific reversal with andexanet is not superior to unspecific reversal with 4PCC, and that’s good news because many centers, in many countries, have no access to specific antidotes that are more costly,” Dr. Gómez-Outes said. “4PCC is an effective and relatively safe drug, so it’s still a good option for these patients.”

Labeling for andexanet includes a warning for thromboembolic events, but in the absence of direct comparisons, the findings should be interpreted with caution, he added. Further insights are expected from an ongoing randomized trial of andexanet and standard of care in 900 patients who present with acute ICH less than 15 hours after taking an oral factor Xa inhibitor. The preliminary completion date is set for 2023.

“The meta-analysis raises awareness about the rates of mortality and thromboembolism after reversal agent administration, although understanding the implications of these data is challenging,” Christopher Granger, MD, and Sean P. Pokomey, MD, MBA, Duke University Medical Center, Durham, N.C., say in an accompanying editorial.

The fact that failure to achieve hemostasis was associated with death is expected and might be related to the way hemostasis was defined, rather than the actual failure of the hemostatic treatments, they suggest. “The prothrombotic effects of each agent, including andexanet, need to be better understood, as clinicians work toward including reversal agents into algorithms for bleeding management.”

Effective hemostasis was defined in the studies through various methods as: “Excellent/good” using the Sarode and ANNEXA-4 scales; “yes” in the International Society on Thrombosis and Hemostasis Scale; and with other scales and through clinical judgment.

Although the size of the meta-analysis dwarfs previous reviews, the editorialists and authors point out that 47 of the 60 studies were retrospective, only two had control groups, and 45 had a high risk for bias.

In general, there was also poor reporting of key clinical data, such as postbleeding anticoagulation management, and a limitation of the mortality analysis is that it was based in selected patients with effective hemostasis assessed within 48 hours, which may not capture early deaths, the authors note.

“The morbidity and mortality from ischemic strokes as a result of undertreatment of stroke prevention in patients with AFib continue to dwarf the bleeding related mortality among patients with AFib and on DOACs, and thus the number one priority is to treat nearly all patients with AFib with a DOAC,” Dr. Granger and Dr. Pokomey conclude. “The availability of reversal agents for DOACs should provide reassurance, with another tool in our armamentarium, to providers to prescribe OACs for stroke prevention.”

No funding/grant support was received to conduct the study. Coauthor Ramón Lecumberri has received personal fees from Boehringer Ingelheim and Bristol Myers Squibb outside the submitted work. All other authors report no relevant financial relationships. Dr. Granger has received research and consulting fees from Bristol Myers Squibb, Pfizer, Boehringer Ingelheim, Bayer, Janssen, Boston Scientific, Apple, AstraZeneca, Novartis, AbbVie, Biomed, CeleCor, GSK, Novartis, Medtronic, Merck, Novo Nordisk, Philips, Rho, and the U.S. Food and Drug Administration. Dr. Pokomey has received modest consulting support from Bristol Myers Squibb, Pfizer, Boston Scientific, Medtronic, Janssen, and Zoll; modest research support from Gilead, Boston Scientific, Bristol Myers Squibb, Pfizer, and Janssen; and significant research support from the FDA.

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

Gerald E. Harmon, MD, a family physician in South Carolina whose patients sometimes leave produce in the back of his pickup truck, has practiced medicine during military deployments and during 15-hour shifts in the COVID-19 pandemic.

He has encountered “all manner of unexpected situations” and feels “more than prepared” to serve as president of the American Medical Association, he said.

At the same time, “I still find myself a little nervous about it,” Dr. Harmon said in an interview the day after he was sworn in as president. “I would be less than candid if I didn’t tell you that. I don’t mean intimidated. ... It’s almost like before an athletic event.”

Dr. Harmon was sworn in June 15 as the 176th president of the AMA during the virtual Special Meeting of the AMA House of Delegates. He follows Susan R. Bailey, MD, an allergist from Fort Worth, Tex., in leading the organization, which has more than 270,000 members.
 

Advancing health equity

During his inaugural address, Dr. Harmon discussed the pandemic and the AMA’s plan to advance health equity.

COVID-19 “has revealed enormous gaps in how we care for people and communities in America, demonstrated in the disproportionate impact of this pandemic on communities of color and in the weaknesses of our underfunded and underresourced public health infrastructure,” Dr. Harmon said.

He described medical professionals as being “at war against seemingly formidable adversaries,” including the pandemic, the effects of prolonged isolation on emotional and behavioral health, and political and racial tension. There is an “immense battle to rid our health system – and society – of health disparities and racism,” he said. “As we face these battles, we must remember that our actions as physicians and as leaders will have far-reaching consequences.”

Other challenges before the AMA include vaccinating patients, recovering from the ongoing pandemic, removing unnecessary obstacles to care, ending an epidemic of drug overdoses, improving outcomes for patients with chronic disease, incorporating technology in ways that benefit doctors and patients, and preparing future physicians, Dr. Harmon noted.

“We are going to embed the principles of equity and racial justice within the AMA and throughout our health system,” added Dr. Harmon, who has been an AMA board member since 2013 and served as board chair from 2017 to 2018. He highlighted the AMA’s strategic plan, released in May 2021, to advance health equity and justice and improve the quality of care for people who have been marginalized.

“Meaningful progress won’t happen until we, as doctors, recognize how profoundly systemic racism influences the health of our patients, and until we commit to taking action within our own spheres of influence,” Dr. Harmon said. “As a family doctor in a very diverse state, I have treated people from all backgrounds, and have seen inequities up close, inequities that understandably lead to distrust.”

Commenting in an interview on JAMA’s controversial tweet and podcast related to structural racism from earlier this year that have been deleted and removed from JAMA’s website, Dr. Harmon said, JAMA maintains editorial independence from the AMA, but that direction from a journal oversight committee could lead to changes at the journal that could help prevent similar incidents.

“We’ll support whatever the journal oversight committee suggests,” Dr. Harmon said.

“We had public statements about [the podcast]. I do think that we’ll be able to move very quickly in a stronger direction to address the issue of systemic racism,” Dr. Harmon said. “The AMA has acknowledged that it is a public health threat. We have acknowledged that it is ... a political description versus a biologic construct. So, I would anticipate that you’ll find changes.”

The AMA began developing its strategic plan to advance equity several years ago, Dr. Harmon noted. “I think we are very well poised to move forward and attack this enemy of health disparity.”
 

AAFP president supporting Dr. Harmon’s inauguration

Among those congratulating Dr. Harmon on his inauguration was Ada Stewart, MD, a fellow family physician and South Carolina resident who is the president of the American Academy of Family Physicians.

“We are very excited that family physician Dr. Gerald Harmon will serve as president of the AMA this coming year,” Dr. Stewart said. “Family medicine encompasses the very essence of medicine – treating the whole person, in the context of family, community, and each individual’s unique circumstances. As a family physician, Dr. Harmon brings important perspectives from the front lines of primary care. His commitment to health equity and evidence-based care, as well as his concern for practice sustainability and physician well-being, will serve him well as he leads the house of medicine into the future.”

Dr. Harmon has practiced as a family medicine specialist in Georgetown, S.C., for more than 30 years. He is a member of the clinical faculty for the Tidelands Health Medical University of South Carolina family medicine residency program, advises a community health system, and is vice president of a multispecialty physician practice. In addition, Dr. Harmon is the medical director of a nonprofit hospice and volunteers as medical supervisor for his local school district.

Dr. Harmon received his undergraduate degree in physics and mathematics from the University of South Carolina, Columbia, and received his medical degree from the Medical University of South Carolina, Charleston. He completed a residency training program in family medicine with the U.S. Air Force at Eglin (Fla.) AFB, Florida.

During a 35-year military career, Dr. Harmon served as chief surgeon for the National Guard Bureau and assistant surgeon general for the U.S. Air Force. He retired from the military as a major general.

Dr. Harmon and his wife, Linda, have three married children and eight grandchildren.

Every now and then, a bucket of tomatoes or even a half bushel of corn shows up in the back of Dr. Harmon’s pickup truck, with a note on the window thanking him. “That really touches you deeply,” Dr. Harmon said. “I practice that type of medicine and I’m honored to be able to do that every day.”

[email protected]

Gerald E. Harmon, MD, a family physician in South Carolina whose patients sometimes leave produce in the back of his pickup truck, has practiced medicine during military deployments and during 15-hour shifts in the COVID-19 pandemic.

He has encountered “all manner of unexpected situations” and feels “more than prepared” to serve as president of the American Medical Association, he said.

At the same time, “I still find myself a little nervous about it,” Dr. Harmon said in an interview the day after he was sworn in as president. “I would be less than candid if I didn’t tell you that. I don’t mean intimidated. ... It’s almost like before an athletic event.”

Dr. Harmon was sworn in June 15 as the 176th president of the AMA during the virtual Special Meeting of the AMA House of Delegates. He follows Susan R. Bailey, MD, an allergist from Fort Worth, Tex., in leading the organization, which has more than 270,000 members.
 

Advancing health equity

During his inaugural address, Dr. Harmon discussed the pandemic and the AMA’s plan to advance health equity.

COVID-19 “has revealed enormous gaps in how we care for people and communities in America, demonstrated in the disproportionate impact of this pandemic on communities of color and in the weaknesses of our underfunded and underresourced public health infrastructure,” Dr. Harmon said.

He described medical professionals as being “at war against seemingly formidable adversaries,” including the pandemic, the effects of prolonged isolation on emotional and behavioral health, and political and racial tension. There is an “immense battle to rid our health system – and society – of health disparities and racism,” he said. “As we face these battles, we must remember that our actions as physicians and as leaders will have far-reaching consequences.”

Other challenges before the AMA include vaccinating patients, recovering from the ongoing pandemic, removing unnecessary obstacles to care, ending an epidemic of drug overdoses, improving outcomes for patients with chronic disease, incorporating technology in ways that benefit doctors and patients, and preparing future physicians, Dr. Harmon noted.

“We are going to embed the principles of equity and racial justice within the AMA and throughout our health system,” added Dr. Harmon, who has been an AMA board member since 2013 and served as board chair from 2017 to 2018. He highlighted the AMA’s strategic plan, released in May 2021, to advance health equity and justice and improve the quality of care for people who have been marginalized.

“Meaningful progress won’t happen until we, as doctors, recognize how profoundly systemic racism influences the health of our patients, and until we commit to taking action within our own spheres of influence,” Dr. Harmon said. “As a family doctor in a very diverse state, I have treated people from all backgrounds, and have seen inequities up close, inequities that understandably lead to distrust.”

Commenting in an interview on JAMA’s controversial tweet and podcast related to structural racism from earlier this year that have been deleted and removed from JAMA’s website, Dr. Harmon said, JAMA maintains editorial independence from the AMA, but that direction from a journal oversight committee could lead to changes at the journal that could help prevent similar incidents.

“We’ll support whatever the journal oversight committee suggests,” Dr. Harmon said.

“We had public statements about [the podcast]. I do think that we’ll be able to move very quickly in a stronger direction to address the issue of systemic racism,” Dr. Harmon said. “The AMA has acknowledged that it is a public health threat. We have acknowledged that it is ... a political description versus a biologic construct. So, I would anticipate that you’ll find changes.”

The AMA began developing its strategic plan to advance equity several years ago, Dr. Harmon noted. “I think we are very well poised to move forward and attack this enemy of health disparity.”
 

AAFP president supporting Dr. Harmon’s inauguration

Among those congratulating Dr. Harmon on his inauguration was Ada Stewart, MD, a fellow family physician and South Carolina resident who is the president of the American Academy of Family Physicians.

“We are very excited that family physician Dr. Gerald Harmon will serve as president of the AMA this coming year,” Dr. Stewart said. “Family medicine encompasses the very essence of medicine – treating the whole person, in the context of family, community, and each individual’s unique circumstances. As a family physician, Dr. Harmon brings important perspectives from the front lines of primary care. His commitment to health equity and evidence-based care, as well as his concern for practice sustainability and physician well-being, will serve him well as he leads the house of medicine into the future.”

Dr. Harmon has practiced as a family medicine specialist in Georgetown, S.C., for more than 30 years. He is a member of the clinical faculty for the Tidelands Health Medical University of South Carolina family medicine residency program, advises a community health system, and is vice president of a multispecialty physician practice. In addition, Dr. Harmon is the medical director of a nonprofit hospice and volunteers as medical supervisor for his local school district.

Dr. Harmon received his undergraduate degree in physics and mathematics from the University of South Carolina, Columbia, and received his medical degree from the Medical University of South Carolina, Charleston. He completed a residency training program in family medicine with the U.S. Air Force at Eglin (Fla.) AFB, Florida.

During a 35-year military career, Dr. Harmon served as chief surgeon for the National Guard Bureau and assistant surgeon general for the U.S. Air Force. He retired from the military as a major general.

Dr. Harmon and his wife, Linda, have three married children and eight grandchildren.

Every now and then, a bucket of tomatoes or even a half bushel of corn shows up in the back of Dr. Harmon’s pickup truck, with a note on the window thanking him. “That really touches you deeply,” Dr. Harmon said. “I practice that type of medicine and I’m honored to be able to do that every day.”

[email protected]

Gerald E. Harmon, MD, a family physician in South Carolina whose patients sometimes leave produce in the back of his pickup truck, has practiced medicine during military deployments and during 15-hour shifts in the COVID-19 pandemic.

He has encountered “all manner of unexpected situations” and feels “more than prepared” to serve as president of the American Medical Association, he said.

At the same time, “I still find myself a little nervous about it,” Dr. Harmon said in an interview the day after he was sworn in as president. “I would be less than candid if I didn’t tell you that. I don’t mean intimidated. ... It’s almost like before an athletic event.”

Dr. Harmon was sworn in June 15 as the 176th president of the AMA during the virtual Special Meeting of the AMA House of Delegates. He follows Susan R. Bailey, MD, an allergist from Fort Worth, Tex., in leading the organization, which has more than 270,000 members.
 

Advancing health equity

During his inaugural address, Dr. Harmon discussed the pandemic and the AMA’s plan to advance health equity.

COVID-19 “has revealed enormous gaps in how we care for people and communities in America, demonstrated in the disproportionate impact of this pandemic on communities of color and in the weaknesses of our underfunded and underresourced public health infrastructure,” Dr. Harmon said.

He described medical professionals as being “at war against seemingly formidable adversaries,” including the pandemic, the effects of prolonged isolation on emotional and behavioral health, and political and racial tension. There is an “immense battle to rid our health system – and society – of health disparities and racism,” he said. “As we face these battles, we must remember that our actions as physicians and as leaders will have far-reaching consequences.”

Other challenges before the AMA include vaccinating patients, recovering from the ongoing pandemic, removing unnecessary obstacles to care, ending an epidemic of drug overdoses, improving outcomes for patients with chronic disease, incorporating technology in ways that benefit doctors and patients, and preparing future physicians, Dr. Harmon noted.

“We are going to embed the principles of equity and racial justice within the AMA and throughout our health system,” added Dr. Harmon, who has been an AMA board member since 2013 and served as board chair from 2017 to 2018. He highlighted the AMA’s strategic plan, released in May 2021, to advance health equity and justice and improve the quality of care for people who have been marginalized.

“Meaningful progress won’t happen until we, as doctors, recognize how profoundly systemic racism influences the health of our patients, and until we commit to taking action within our own spheres of influence,” Dr. Harmon said. “As a family doctor in a very diverse state, I have treated people from all backgrounds, and have seen inequities up close, inequities that understandably lead to distrust.”

Commenting in an interview on JAMA’s controversial tweet and podcast related to structural racism from earlier this year that have been deleted and removed from JAMA’s website, Dr. Harmon said, JAMA maintains editorial independence from the AMA, but that direction from a journal oversight committee could lead to changes at the journal that could help prevent similar incidents.

“We’ll support whatever the journal oversight committee suggests,” Dr. Harmon said.

“We had public statements about [the podcast]. I do think that we’ll be able to move very quickly in a stronger direction to address the issue of systemic racism,” Dr. Harmon said. “The AMA has acknowledged that it is a public health threat. We have acknowledged that it is ... a political description versus a biologic construct. So, I would anticipate that you’ll find changes.”

The AMA began developing its strategic plan to advance equity several years ago, Dr. Harmon noted. “I think we are very well poised to move forward and attack this enemy of health disparity.”
 

AAFP president supporting Dr. Harmon’s inauguration

Among those congratulating Dr. Harmon on his inauguration was Ada Stewart, MD, a fellow family physician and South Carolina resident who is the president of the American Academy of Family Physicians.

“We are very excited that family physician Dr. Gerald Harmon will serve as president of the AMA this coming year,” Dr. Stewart said. “Family medicine encompasses the very essence of medicine – treating the whole person, in the context of family, community, and each individual’s unique circumstances. As a family physician, Dr. Harmon brings important perspectives from the front lines of primary care. His commitment to health equity and evidence-based care, as well as his concern for practice sustainability and physician well-being, will serve him well as he leads the house of medicine into the future.”

Dr. Harmon has practiced as a family medicine specialist in Georgetown, S.C., for more than 30 years. He is a member of the clinical faculty for the Tidelands Health Medical University of South Carolina family medicine residency program, advises a community health system, and is vice president of a multispecialty physician practice. In addition, Dr. Harmon is the medical director of a nonprofit hospice and volunteers as medical supervisor for his local school district.

Dr. Harmon received his undergraduate degree in physics and mathematics from the University of South Carolina, Columbia, and received his medical degree from the Medical University of South Carolina, Charleston. He completed a residency training program in family medicine with the U.S. Air Force at Eglin (Fla.) AFB, Florida.

During a 35-year military career, Dr. Harmon served as chief surgeon for the National Guard Bureau and assistant surgeon general for the U.S. Air Force. He retired from the military as a major general.

Dr. Harmon and his wife, Linda, have three married children and eight grandchildren.

Every now and then, a bucket of tomatoes or even a half bushel of corn shows up in the back of Dr. Harmon’s pickup truck, with a note on the window thanking him. “That really touches you deeply,” Dr. Harmon said. “I practice that type of medicine and I’m honored to be able to do that every day.”

[email protected]

The U.S. Supreme Court upheld the Affordable Care Act June 17 in a 7 to 2 vote, rejecting claims by the challengers that the requirement for all Americans to obtain health insurance is unconstitutional.

ETIENJones/thinkstockphotos

The challengers were comprised of 18 GOP-dominated states, led by Texas, that took issue with the ACA’s individual mandate – which required most Americans to have health insurance or pay a tax penalty.

But Congress reduced the penalty to zero in 2017. Challengers argued that without the mandate,  the rest of the law should be scrapped, too. The court ruled that eliminated the harm the states were claiming.

“To have standing, a plaintiff must ‘allege personal injury fairly traceable to the defendant’s allegedly unlawful conduct and likely to be redressed by the requested relief,’” the majority wrote. “No plaintiff has shown such an injury ‘fairly traceable’ to the ‘allegedly unlawful conduct’ challenged here.”

Justice Stephen Breyer authored the opinion. Justices Samuel Alito and Neil Gorsuch dissented.

The decision said that the mandate in question did not require the 18 states that brought the complaint to pay anything, and therefore they had no standing.

President Joe Biden has said he plans to build on the ACA – which was enacted while he was vice president – to offer coverage to more Americans.

This marks the third time the Supreme Court spared the Obama-era law from GOP attacks. The mandate was also upheld in 2012 in a 5 to 4 ruling.

American Medical Association president Gerald Harmon, MD, also called for building on the ruling to expand the law.

“With yet another court decision upholding the ACA now behind us, we remain committed to strengthening the current law and look forward to policymakers advancing solutions to improve the ACA,” Dr. Harmon said in a statement. “The AMA will continue working to expand access to health care and ensure that all Americans have meaningful, comprehensive, and affordable health coverage to improve the health of the nation.”

House Speaker Nancy Pelosi (D-Calif.), a longtime advocate for the ACA, called the decision a “landmark victory for Democrats.”

“Thanks to the tireless advocacy of Americans across the country and Democrats in Congress, the Affordable Care Act endures as a pillar of American health and economic security alongside Medicare, Medicaid and Social Security,” she said in a statement.

Senate Majority Leader Chuck Schumer (D-N.Y.) also celebrated the ruling.

“The Affordable Care Act has won. The Supreme Court has just ruled: the ACA is here to stay and now we’re going to try to make it bigger and better,” he said, according to CNN. “For more than a decade, the assault on our health care law was relentless from Republicans in Congress, from the executive branch itself and from Republican attorneys general in the courts. Each time in each arena, the ACA has prevailed.”

This article was updated June 17, 2021.

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

The U.S. Supreme Court upheld the Affordable Care Act June 17 in a 7 to 2 vote, rejecting claims by the challengers that the requirement for all Americans to obtain health insurance is unconstitutional.

ETIENJones/thinkstockphotos

The challengers were comprised of 18 GOP-dominated states, led by Texas, that took issue with the ACA’s individual mandate – which required most Americans to have health insurance or pay a tax penalty.

But Congress reduced the penalty to zero in 2017. Challengers argued that without the mandate,  the rest of the law should be scrapped, too. The court ruled that eliminated the harm the states were claiming.

“To have standing, a plaintiff must ‘allege personal injury fairly traceable to the defendant’s allegedly unlawful conduct and likely to be redressed by the requested relief,’” the majority wrote. “No plaintiff has shown such an injury ‘fairly traceable’ to the ‘allegedly unlawful conduct’ challenged here.”

Justice Stephen Breyer authored the opinion. Justices Samuel Alito and Neil Gorsuch dissented.

The decision said that the mandate in question did not require the 18 states that brought the complaint to pay anything, and therefore they had no standing.

President Joe Biden has said he plans to build on the ACA – which was enacted while he was vice president – to offer coverage to more Americans.

This marks the third time the Supreme Court spared the Obama-era law from GOP attacks. The mandate was also upheld in 2012 in a 5 to 4 ruling.

American Medical Association president Gerald Harmon, MD, also called for building on the ruling to expand the law.

“With yet another court decision upholding the ACA now behind us, we remain committed to strengthening the current law and look forward to policymakers advancing solutions to improve the ACA,” Dr. Harmon said in a statement. “The AMA will continue working to expand access to health care and ensure that all Americans have meaningful, comprehensive, and affordable health coverage to improve the health of the nation.”

House Speaker Nancy Pelosi (D-Calif.), a longtime advocate for the ACA, called the decision a “landmark victory for Democrats.”

“Thanks to the tireless advocacy of Americans across the country and Democrats in Congress, the Affordable Care Act endures as a pillar of American health and economic security alongside Medicare, Medicaid and Social Security,” she said in a statement.

Senate Majority Leader Chuck Schumer (D-N.Y.) also celebrated the ruling.

“The Affordable Care Act has won. The Supreme Court has just ruled: the ACA is here to stay and now we’re going to try to make it bigger and better,” he said, according to CNN. “For more than a decade, the assault on our health care law was relentless from Republicans in Congress, from the executive branch itself and from Republican attorneys general in the courts. Each time in each arena, the ACA has prevailed.”

This article was updated June 17, 2021.

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

The U.S. Supreme Court upheld the Affordable Care Act June 17 in a 7 to 2 vote, rejecting claims by the challengers that the requirement for all Americans to obtain health insurance is unconstitutional.

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The challengers were comprised of 18 GOP-dominated states, led by Texas, that took issue with the ACA’s individual mandate – which required most Americans to have health insurance or pay a tax penalty.

But Congress reduced the penalty to zero in 2017. Challengers argued that without the mandate,  the rest of the law should be scrapped, too. The court ruled that eliminated the harm the states were claiming.

“To have standing, a plaintiff must ‘allege personal injury fairly traceable to the defendant’s allegedly unlawful conduct and likely to be redressed by the requested relief,’” the majority wrote. “No plaintiff has shown such an injury ‘fairly traceable’ to the ‘allegedly unlawful conduct’ challenged here.”

Justice Stephen Breyer authored the opinion. Justices Samuel Alito and Neil Gorsuch dissented.

The decision said that the mandate in question did not require the 18 states that brought the complaint to pay anything, and therefore they had no standing.

President Joe Biden has said he plans to build on the ACA – which was enacted while he was vice president – to offer coverage to more Americans.

This marks the third time the Supreme Court spared the Obama-era law from GOP attacks. The mandate was also upheld in 2012 in a 5 to 4 ruling.

American Medical Association president Gerald Harmon, MD, also called for building on the ruling to expand the law.

“With yet another court decision upholding the ACA now behind us, we remain committed to strengthening the current law and look forward to policymakers advancing solutions to improve the ACA,” Dr. Harmon said in a statement. “The AMA will continue working to expand access to health care and ensure that all Americans have meaningful, comprehensive, and affordable health coverage to improve the health of the nation.”

House Speaker Nancy Pelosi (D-Calif.), a longtime advocate for the ACA, called the decision a “landmark victory for Democrats.”

“Thanks to the tireless advocacy of Americans across the country and Democrats in Congress, the Affordable Care Act endures as a pillar of American health and economic security alongside Medicare, Medicaid and Social Security,” she said in a statement.

Senate Majority Leader Chuck Schumer (D-N.Y.) also celebrated the ruling.

“The Affordable Care Act has won. The Supreme Court has just ruled: the ACA is here to stay and now we’re going to try to make it bigger and better,” he said, according to CNN. “For more than a decade, the assault on our health care law was relentless from Republicans in Congress, from the executive branch itself and from Republican attorneys general in the courts. Each time in each arena, the ACA has prevailed.”

This article was updated June 17, 2021.

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