After a heart attack, the damaged area of the heart often becomes scar tissue that can’t receive electrical messages to contract and pump blood to the body. The result is a weakened heart that could get an irregular beat, known as an arrhythmia, or go into failure.

Right now, doctors have two imperfect options for repairing this damaged tissue. One is to surgically implant a scaffold that conducts electrically and bridges the heart’s signaling system past the dead tissue. But these implants require open-chest surgery, which is risky and can lead to other heart problems.

Clinicians can use an approach that avoids opening the chest, but the patch used for these procedures may not hold its shape when grafted to damaged tissue.

Now, scientists may be working on a fix that promises the best of both worlds: an injectable patch that conducts electricity and keeps its shape once grafted to heart muscle.

The patch hasn’t been tested in humans -- any such trials are still a long way off -- but early results in animals show potential.

This experimental patch can be rolled up, threaded into a catheter or a syringe, and injected into damaged heart tissue, where it unfurls and attaches to the muscle. Once in place, the patch supports normal heart function, according to results from studies using rats and pigs. The findings were published in Nature Biomedical Engineering.

When researchers placed the patch on damaged heart muscle in rats, they found this fix resulted in a return to mostly normal heart function within 4 weeks. Results were similar when scientists tested the patch in a small number of pigs, which are considered to resemble humans more closely than rodents.

The patched hearts did a better job in pumping oxygen-rich blood to the body, and the amount of heart tissue that wasn’t getting enough oxygen also declined.

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

After a heart attack, the damaged area of the heart often becomes scar tissue that can’t receive electrical messages to contract and pump blood to the body. The result is a weakened heart that could get an irregular beat, known as an arrhythmia, or go into failure.

Right now, doctors have two imperfect options for repairing this damaged tissue. One is to surgically implant a scaffold that conducts electrically and bridges the heart’s signaling system past the dead tissue. But these implants require open-chest surgery, which is risky and can lead to other heart problems.

Clinicians can use an approach that avoids opening the chest, but the patch used for these procedures may not hold its shape when grafted to damaged tissue.

Now, scientists may be working on a fix that promises the best of both worlds: an injectable patch that conducts electricity and keeps its shape once grafted to heart muscle.

The patch hasn’t been tested in humans -- any such trials are still a long way off -- but early results in animals show potential.

This experimental patch can be rolled up, threaded into a catheter or a syringe, and injected into damaged heart tissue, where it unfurls and attaches to the muscle. Once in place, the patch supports normal heart function, according to results from studies using rats and pigs. The findings were published in Nature Biomedical Engineering.

When researchers placed the patch on damaged heart muscle in rats, they found this fix resulted in a return to mostly normal heart function within 4 weeks. Results were similar when scientists tested the patch in a small number of pigs, which are considered to resemble humans more closely than rodents.

The patched hearts did a better job in pumping oxygen-rich blood to the body, and the amount of heart tissue that wasn’t getting enough oxygen also declined.

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

After a heart attack, the damaged area of the heart often becomes scar tissue that can’t receive electrical messages to contract and pump blood to the body. The result is a weakened heart that could get an irregular beat, known as an arrhythmia, or go into failure.

Right now, doctors have two imperfect options for repairing this damaged tissue. One is to surgically implant a scaffold that conducts electrically and bridges the heart’s signaling system past the dead tissue. But these implants require open-chest surgery, which is risky and can lead to other heart problems.

Clinicians can use an approach that avoids opening the chest, but the patch used for these procedures may not hold its shape when grafted to damaged tissue.

Now, scientists may be working on a fix that promises the best of both worlds: an injectable patch that conducts electricity and keeps its shape once grafted to heart muscle.

The patch hasn’t been tested in humans -- any such trials are still a long way off -- but early results in animals show potential.

This experimental patch can be rolled up, threaded into a catheter or a syringe, and injected into damaged heart tissue, where it unfurls and attaches to the muscle. Once in place, the patch supports normal heart function, according to results from studies using rats and pigs. The findings were published in Nature Biomedical Engineering.

When researchers placed the patch on damaged heart muscle in rats, they found this fix resulted in a return to mostly normal heart function within 4 weeks. Results were similar when scientists tested the patch in a small number of pigs, which are considered to resemble humans more closely than rodents.

The patched hearts did a better job in pumping oxygen-rich blood to the body, and the amount of heart tissue that wasn’t getting enough oxygen also declined.

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

While the U.S. Food and Drug Administration has yet to give the green light to COVID-19 vaccination for children who are under age 12, it is expected that approval will be granted. In anticipation of the FDA’s go-ahead, which is expected in the coming weeks, a new “rapid expert consultation” has identified “actionable guidance” that state and local decision-makers can use to communicate with the public. The goal is to build confidence in and promote the uptake of COVID-19 vaccines, especially for parents who are contemplating vaccinating their children.

They note that key factors in decision-making concern vaccine side effects, the efficacy of the vaccine in children, availability of research in their child’s age group, research conducted by the parents themselves, and recommendations by the child’s health care provider.

“One of the reasons that the COVID vaccine only became available for children 12 and over months after it was approved for adults is that it takes time and many, many trial participants who are closely monitored before the vaccine ever reaches the general public,” said Nusheen Ameenuddin, MD, MPH, MPA, an assistant professor of pediatrics at the Mayo Clinic, Rochester, Minn. “We continue to talk to parents about the fact that the vaccines have been very safe and effective in this group, and even though people are concerned about side effects, they are much milder and less frequent than the effects of the disease itself.”

Dr. Ameenuddin noted that the lack of data in this age group can be concerning for parents. “It’s not like other vaccines which have been available for a long time, and the clinical trial data are still limited for this age group,” she said. “But I think the main point that practitioners need to emphasize is that, even though the vaccine is new, the science for this vaccine has been around for about a decade.”

The unique circumstances of a pandemic, she pointed out, allowed for important information about effectiveness, safety, and side effects to be obtained more quickly from clinical trial data.

“We have really good evidence for kids 12 and over, about safety and effectiveness, and even though children are not small adults and have their own unique physiology, this has provided a good starting point to suggest that kids slightly younger will also respond well to the vaccines,” said Dr. Ameenuddin, who is also chair of the American Academy of Pediatrics Council on Communications and Media. “As we learn more, we can start gathering more information about even younger kids to ensure that the right dosage and spacing of vaccines can provide maximum vaccine effectiveness and protection from disease.”

The guidance was published Oct. 13 by the National Academies of Sciences, Engineering, and Medicine.

The rapid expert consultation was produced through the Societal Experts Action Network, an activity of the National Academies that is sponsored by the NASEM and the Alfred P. Sloan Foundation. The goal of SEAN is to connect researchers in the social, behavioral, and economic sciences with decision-makers to respond to policy questions related to the COVID-19 pandemic.

In their expert consultation, the authors emphasize that vaccination is critical for decreasing transmission and controlling infection, as well as limiting the emergence of future serious variants. As of Oct. 3, 2021, about 65% of the U.S. population had received at least one dose of the vaccine, and the rate has begun to lag in many areas of the country. There are a variety of reasons for vaccine hesitancy, they note, including perception of low risks from COVID-19 or of high risks from COVID-19 vaccines, exposure to media, political agendas, lack of confidence in science, and distrust of the medical establishment. The Pfizer/BioNTech vaccine is currently authorized for emergency use for individuals 12 years of age and older and fully approved for those aged 16 and older, while the Moderna and the Johnson & Johnson vaccines are authorized for emergency use for those 18 years of age and older.

Many children between the ages of 12 and 17 have not been vaccinated, and the major concerns reported by parents include not knowing enough about the long-term effects of the COVID-19 vaccine in children (88%), concerns about children experiencing serious side effects (79%), and concerns that the COVID-19 vaccine might negatively affect future fertility (73%).

The National Academies have previously released two other “rapid expert consultations” which have addressed building vaccine confidence, and both reports provide key strategies for communicating information about COVID-19 vaccines. In this paper, the focus was on communicating with parents to gain confidence in the vaccine and address concerns.
 

Key points

The key strategies highlighted for communicating with parents include the following:

• Emphasizing safety and efficacy: Parents should be informed about the ongoing research and clinical trials that will answer more questions about the vaccine and that there is continued monitoring for any safety risks. Pointing to the safety data from the clinical trials for 12- to 17-year-olds, and the lack of serious adverse events from the vaccine in this age group may help alleviate concerns.
• CalibriEncouraging parents to talk with a primary care provider: Research shows that parents trust family physicians and other health care practitioners to provide them with accurate information about vaccines. Local, state, and national leaders can provide messaging templates and other resources to health care professionals who are engaged in these conversations.
• Leveraging social networks to influence parents’ vaccination decisions: Parents are influenced by their social network connections. It is important to engage these networks, especially with members of their community who are considered trustworthy and influential. Social networks may also be very diverse, and include family members, friends, coworkers, social media, and members of their religious community.

While the guidance states that different groups of parents will require different messaging, they suggest that communication can begin with a focus on the things that vaccination can accomplish. In addition to preventing infection with COVID-19, it will allow children to attend school in person and participate in extracurricular activities such as sports, without risking their health. “One thing I’ve learned over several years of working with vaccine-hesitant parents is that you have to tailor each approach to the individual,” said Dr. Ameenuddin. “Different people have different concerns, and first and foremost, it’s important to listen.”

For some parents, emphasizing that the more people that can be vaccinated and the sooner it can be done, the sooner everyone can return to a normal life is a good approach, she added. “I think it’s important to emphasize both the individual and communal benefits of vaccines, but that won’t necessarily reach every person with concerns. I think it’s important to find out what is most important to individuals and work from there to find a way to connect with that family to encourage vaccination.”

Dr. Ameenuddin has no disclosures.

While the U.S. Food and Drug Administration has yet to give the green light to COVID-19 vaccination for children who are under age 12, it is expected that approval will be granted. In anticipation of the FDA’s go-ahead, which is expected in the coming weeks, a new “rapid expert consultation” has identified “actionable guidance” that state and local decision-makers can use to communicate with the public. The goal is to build confidence in and promote the uptake of COVID-19 vaccines, especially for parents who are contemplating vaccinating their children.

They note that key factors in decision-making concern vaccine side effects, the efficacy of the vaccine in children, availability of research in their child’s age group, research conducted by the parents themselves, and recommendations by the child’s health care provider.

“One of the reasons that the COVID vaccine only became available for children 12 and over months after it was approved for adults is that it takes time and many, many trial participants who are closely monitored before the vaccine ever reaches the general public,” said Nusheen Ameenuddin, MD, MPH, MPA, an assistant professor of pediatrics at the Mayo Clinic, Rochester, Minn. “We continue to talk to parents about the fact that the vaccines have been very safe and effective in this group, and even though people are concerned about side effects, they are much milder and less frequent than the effects of the disease itself.”

Dr. Ameenuddin noted that the lack of data in this age group can be concerning for parents. “It’s not like other vaccines which have been available for a long time, and the clinical trial data are still limited for this age group,” she said. “But I think the main point that practitioners need to emphasize is that, even though the vaccine is new, the science for this vaccine has been around for about a decade.”

The unique circumstances of a pandemic, she pointed out, allowed for important information about effectiveness, safety, and side effects to be obtained more quickly from clinical trial data.

“We have really good evidence for kids 12 and over, about safety and effectiveness, and even though children are not small adults and have their own unique physiology, this has provided a good starting point to suggest that kids slightly younger will also respond well to the vaccines,” said Dr. Ameenuddin, who is also chair of the American Academy of Pediatrics Council on Communications and Media. “As we learn more, we can start gathering more information about even younger kids to ensure that the right dosage and spacing of vaccines can provide maximum vaccine effectiveness and protection from disease.”

The guidance was published Oct. 13 by the National Academies of Sciences, Engineering, and Medicine.

The rapid expert consultation was produced through the Societal Experts Action Network, an activity of the National Academies that is sponsored by the NASEM and the Alfred P. Sloan Foundation. The goal of SEAN is to connect researchers in the social, behavioral, and economic sciences with decision-makers to respond to policy questions related to the COVID-19 pandemic.

In their expert consultation, the authors emphasize that vaccination is critical for decreasing transmission and controlling infection, as well as limiting the emergence of future serious variants. As of Oct. 3, 2021, about 65% of the U.S. population had received at least one dose of the vaccine, and the rate has begun to lag in many areas of the country. There are a variety of reasons for vaccine hesitancy, they note, including perception of low risks from COVID-19 or of high risks from COVID-19 vaccines, exposure to media, political agendas, lack of confidence in science, and distrust of the medical establishment. The Pfizer/BioNTech vaccine is currently authorized for emergency use for individuals 12 years of age and older and fully approved for those aged 16 and older, while the Moderna and the Johnson & Johnson vaccines are authorized for emergency use for those 18 years of age and older.

Many children between the ages of 12 and 17 have not been vaccinated, and the major concerns reported by parents include not knowing enough about the long-term effects of the COVID-19 vaccine in children (88%), concerns about children experiencing serious side effects (79%), and concerns that the COVID-19 vaccine might negatively affect future fertility (73%).

The National Academies have previously released two other “rapid expert consultations” which have addressed building vaccine confidence, and both reports provide key strategies for communicating information about COVID-19 vaccines. In this paper, the focus was on communicating with parents to gain confidence in the vaccine and address concerns.
 

Key points

The key strategies highlighted for communicating with parents include the following:

• Emphasizing safety and efficacy: Parents should be informed about the ongoing research and clinical trials that will answer more questions about the vaccine and that there is continued monitoring for any safety risks. Pointing to the safety data from the clinical trials for 12- to 17-year-olds, and the lack of serious adverse events from the vaccine in this age group may help alleviate concerns.
• CalibriEncouraging parents to talk with a primary care provider: Research shows that parents trust family physicians and other health care practitioners to provide them with accurate information about vaccines. Local, state, and national leaders can provide messaging templates and other resources to health care professionals who are engaged in these conversations.
• Leveraging social networks to influence parents’ vaccination decisions: Parents are influenced by their social network connections. It is important to engage these networks, especially with members of their community who are considered trustworthy and influential. Social networks may also be very diverse, and include family members, friends, coworkers, social media, and members of their religious community.

While the guidance states that different groups of parents will require different messaging, they suggest that communication can begin with a focus on the things that vaccination can accomplish. In addition to preventing infection with COVID-19, it will allow children to attend school in person and participate in extracurricular activities such as sports, without risking their health. “One thing I’ve learned over several years of working with vaccine-hesitant parents is that you have to tailor each approach to the individual,” said Dr. Ameenuddin. “Different people have different concerns, and first and foremost, it’s important to listen.”

For some parents, emphasizing that the more people that can be vaccinated and the sooner it can be done, the sooner everyone can return to a normal life is a good approach, she added. “I think it’s important to emphasize both the individual and communal benefits of vaccines, but that won’t necessarily reach every person with concerns. I think it’s important to find out what is most important to individuals and work from there to find a way to connect with that family to encourage vaccination.”

Dr. Ameenuddin has no disclosures.

While the U.S. Food and Drug Administration has yet to give the green light to COVID-19 vaccination for children who are under age 12, it is expected that approval will be granted. In anticipation of the FDA’s go-ahead, which is expected in the coming weeks, a new “rapid expert consultation” has identified “actionable guidance” that state and local decision-makers can use to communicate with the public. The goal is to build confidence in and promote the uptake of COVID-19 vaccines, especially for parents who are contemplating vaccinating their children.

They note that key factors in decision-making concern vaccine side effects, the efficacy of the vaccine in children, availability of research in their child’s age group, research conducted by the parents themselves, and recommendations by the child’s health care provider.

“One of the reasons that the COVID vaccine only became available for children 12 and over months after it was approved for adults is that it takes time and many, many trial participants who are closely monitored before the vaccine ever reaches the general public,” said Nusheen Ameenuddin, MD, MPH, MPA, an assistant professor of pediatrics at the Mayo Clinic, Rochester, Minn. “We continue to talk to parents about the fact that the vaccines have been very safe and effective in this group, and even though people are concerned about side effects, they are much milder and less frequent than the effects of the disease itself.”

Dr. Ameenuddin noted that the lack of data in this age group can be concerning for parents. “It’s not like other vaccines which have been available for a long time, and the clinical trial data are still limited for this age group,” she said. “But I think the main point that practitioners need to emphasize is that, even though the vaccine is new, the science for this vaccine has been around for about a decade.”

The unique circumstances of a pandemic, she pointed out, allowed for important information about effectiveness, safety, and side effects to be obtained more quickly from clinical trial data.

“We have really good evidence for kids 12 and over, about safety and effectiveness, and even though children are not small adults and have their own unique physiology, this has provided a good starting point to suggest that kids slightly younger will also respond well to the vaccines,” said Dr. Ameenuddin, who is also chair of the American Academy of Pediatrics Council on Communications and Media. “As we learn more, we can start gathering more information about even younger kids to ensure that the right dosage and spacing of vaccines can provide maximum vaccine effectiveness and protection from disease.”

The guidance was published Oct. 13 by the National Academies of Sciences, Engineering, and Medicine.

The rapid expert consultation was produced through the Societal Experts Action Network, an activity of the National Academies that is sponsored by the NASEM and the Alfred P. Sloan Foundation. The goal of SEAN is to connect researchers in the social, behavioral, and economic sciences with decision-makers to respond to policy questions related to the COVID-19 pandemic.

In their expert consultation, the authors emphasize that vaccination is critical for decreasing transmission and controlling infection, as well as limiting the emergence of future serious variants. As of Oct. 3, 2021, about 65% of the U.S. population had received at least one dose of the vaccine, and the rate has begun to lag in many areas of the country. There are a variety of reasons for vaccine hesitancy, they note, including perception of low risks from COVID-19 or of high risks from COVID-19 vaccines, exposure to media, political agendas, lack of confidence in science, and distrust of the medical establishment. The Pfizer/BioNTech vaccine is currently authorized for emergency use for individuals 12 years of age and older and fully approved for those aged 16 and older, while the Moderna and the Johnson & Johnson vaccines are authorized for emergency use for those 18 years of age and older.

Many children between the ages of 12 and 17 have not been vaccinated, and the major concerns reported by parents include not knowing enough about the long-term effects of the COVID-19 vaccine in children (88%), concerns about children experiencing serious side effects (79%), and concerns that the COVID-19 vaccine might negatively affect future fertility (73%).

The National Academies have previously released two other “rapid expert consultations” which have addressed building vaccine confidence, and both reports provide key strategies for communicating information about COVID-19 vaccines. In this paper, the focus was on communicating with parents to gain confidence in the vaccine and address concerns.
 

Key points

The key strategies highlighted for communicating with parents include the following:

• Emphasizing safety and efficacy: Parents should be informed about the ongoing research and clinical trials that will answer more questions about the vaccine and that there is continued monitoring for any safety risks. Pointing to the safety data from the clinical trials for 12- to 17-year-olds, and the lack of serious adverse events from the vaccine in this age group may help alleviate concerns.
• CalibriEncouraging parents to talk with a primary care provider: Research shows that parents trust family physicians and other health care practitioners to provide them with accurate information about vaccines. Local, state, and national leaders can provide messaging templates and other resources to health care professionals who are engaged in these conversations.
• Leveraging social networks to influence parents’ vaccination decisions: Parents are influenced by their social network connections. It is important to engage these networks, especially with members of their community who are considered trustworthy and influential. Social networks may also be very diverse, and include family members, friends, coworkers, social media, and members of their religious community.

While the guidance states that different groups of parents will require different messaging, they suggest that communication can begin with a focus on the things that vaccination can accomplish. In addition to preventing infection with COVID-19, it will allow children to attend school in person and participate in extracurricular activities such as sports, without risking their health. “One thing I’ve learned over several years of working with vaccine-hesitant parents is that you have to tailor each approach to the individual,” said Dr. Ameenuddin. “Different people have different concerns, and first and foremost, it’s important to listen.”

For some parents, emphasizing that the more people that can be vaccinated and the sooner it can be done, the sooner everyone can return to a normal life is a good approach, she added. “I think it’s important to emphasize both the individual and communal benefits of vaccines, but that won’t necessarily reach every person with concerns. I think it’s important to find out what is most important to individuals and work from there to find a way to connect with that family to encourage vaccination.”

Dr. Ameenuddin has no disclosures.

A physician assistant who runs a pediatric clinic in Washington State says he’ll fight against a license suspension over prescribing ivermectin as a cure for COVID, among other allegations.

The suspension stemmed from allegations against Scott C. Miller, PA-C, by at least six COVID patients, including some who weren’t his patients or whom he never examined and a few who later died from the virus, according to the Washington Medical Commission.

“Miller’s treatment of COVID-19 patients fell below the standard of care,” the suspension report states. “Miller began a public campaign promoting ivermectin as a curative for COVID-19, and prescribing it without adequate examination to at least one person, with no reliable clinical studies that establish its efficacy in preventing or treating COVID-19.”

Mr. Miller has until early November to respond to the allegations. On his clinic’s website, Mr. Miller stated, “In response to the charges, I want to reassure all of you that the initial attacks against me have been brought on by a small handful of people that have no ties to our medical practice, and by pharmacies and hospitals that have a zero tolerance policy on family members asking that I help them advocate for loved ones that have been admitted and written off in our current system of dismissiveness and neglect.”

Mr. Miller also expressed gratitude for the support he has received recently. A GoFundMe campaign to raise money for Mr. Miller’s legal fund had raised more than $59,000 at press time. His GoFundMe page had been shared 2,400 times. He has more than 550 followers and more than 400 donors.

“I don’t know that I have the words to adequately describe the deep sense of love and connection I have received from you, the families I serve, and those that have reached out to me in this deeply challenging time,” he wrote on the clinic website.

Mr. Miller has spoken publicly about his anti-mask views and his support for ivermectin, according to the commission report. As part of the suspension, he was charged with making “misleading representations regarding the efficacy of non-FDA approved treatment and mask use.”

In one case that was cited in the report, a 39-year-old patient contacted the pediatric clinic, and Mr. Miller spoke with the patient by phone. The patient reported that he had tested positive for COVID. Mr. Miller advised the patient to take supplements, including vitamin D and C, zinc, and melatonin, and he prescribed ivermectin, dexamethasone, and azithromycin. He did not perform an exam, verify the information that the patient had provided, advise the patient regarding interactions, or order follow-up testing, the report states.

Other charges against Mr. Miller include harassing hospital staff by making threatening statements about hospitals and doctors who treat COVID-19 patients and misrepresenting his original 2013 license application. He denied on the application that he was being investigated by another licensing board. At the time, the California Physician Assistant Board was investigating him for providing medical care and prescribing without a supervising doctor’s authorization and without conducting physical exams, among other charges.

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

A physician assistant who runs a pediatric clinic in Washington State says he’ll fight against a license suspension over prescribing ivermectin as a cure for COVID, among other allegations.

The suspension stemmed from allegations against Scott C. Miller, PA-C, by at least six COVID patients, including some who weren’t his patients or whom he never examined and a few who later died from the virus, according to the Washington Medical Commission.

“Miller’s treatment of COVID-19 patients fell below the standard of care,” the suspension report states. “Miller began a public campaign promoting ivermectin as a curative for COVID-19, and prescribing it without adequate examination to at least one person, with no reliable clinical studies that establish its efficacy in preventing or treating COVID-19.”

Mr. Miller has until early November to respond to the allegations. On his clinic’s website, Mr. Miller stated, “In response to the charges, I want to reassure all of you that the initial attacks against me have been brought on by a small handful of people that have no ties to our medical practice, and by pharmacies and hospitals that have a zero tolerance policy on family members asking that I help them advocate for loved ones that have been admitted and written off in our current system of dismissiveness and neglect.”

Mr. Miller also expressed gratitude for the support he has received recently. A GoFundMe campaign to raise money for Mr. Miller’s legal fund had raised more than $59,000 at press time. His GoFundMe page had been shared 2,400 times. He has more than 550 followers and more than 400 donors.

“I don’t know that I have the words to adequately describe the deep sense of love and connection I have received from you, the families I serve, and those that have reached out to me in this deeply challenging time,” he wrote on the clinic website.

Mr. Miller has spoken publicly about his anti-mask views and his support for ivermectin, according to the commission report. As part of the suspension, he was charged with making “misleading representations regarding the efficacy of non-FDA approved treatment and mask use.”

In one case that was cited in the report, a 39-year-old patient contacted the pediatric clinic, and Mr. Miller spoke with the patient by phone. The patient reported that he had tested positive for COVID. Mr. Miller advised the patient to take supplements, including vitamin D and C, zinc, and melatonin, and he prescribed ivermectin, dexamethasone, and azithromycin. He did not perform an exam, verify the information that the patient had provided, advise the patient regarding interactions, or order follow-up testing, the report states.

Other charges against Mr. Miller include harassing hospital staff by making threatening statements about hospitals and doctors who treat COVID-19 patients and misrepresenting his original 2013 license application. He denied on the application that he was being investigated by another licensing board. At the time, the California Physician Assistant Board was investigating him for providing medical care and prescribing without a supervising doctor’s authorization and without conducting physical exams, among other charges.

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

A physician assistant who runs a pediatric clinic in Washington State says he’ll fight against a license suspension over prescribing ivermectin as a cure for COVID, among other allegations.

The suspension stemmed from allegations against Scott C. Miller, PA-C, by at least six COVID patients, including some who weren’t his patients or whom he never examined and a few who later died from the virus, according to the Washington Medical Commission.

“Miller’s treatment of COVID-19 patients fell below the standard of care,” the suspension report states. “Miller began a public campaign promoting ivermectin as a curative for COVID-19, and prescribing it without adequate examination to at least one person, with no reliable clinical studies that establish its efficacy in preventing or treating COVID-19.”

Mr. Miller has until early November to respond to the allegations. On his clinic’s website, Mr. Miller stated, “In response to the charges, I want to reassure all of you that the initial attacks against me have been brought on by a small handful of people that have no ties to our medical practice, and by pharmacies and hospitals that have a zero tolerance policy on family members asking that I help them advocate for loved ones that have been admitted and written off in our current system of dismissiveness and neglect.”

Mr. Miller also expressed gratitude for the support he has received recently. A GoFundMe campaign to raise money for Mr. Miller’s legal fund had raised more than $59,000 at press time. His GoFundMe page had been shared 2,400 times. He has more than 550 followers and more than 400 donors.

“I don’t know that I have the words to adequately describe the deep sense of love and connection I have received from you, the families I serve, and those that have reached out to me in this deeply challenging time,” he wrote on the clinic website.

Mr. Miller has spoken publicly about his anti-mask views and his support for ivermectin, according to the commission report. As part of the suspension, he was charged with making “misleading representations regarding the efficacy of non-FDA approved treatment and mask use.”

In one case that was cited in the report, a 39-year-old patient contacted the pediatric clinic, and Mr. Miller spoke with the patient by phone. The patient reported that he had tested positive for COVID. Mr. Miller advised the patient to take supplements, including vitamin D and C, zinc, and melatonin, and he prescribed ivermectin, dexamethasone, and azithromycin. He did not perform an exam, verify the information that the patient had provided, advise the patient regarding interactions, or order follow-up testing, the report states.

Other charges against Mr. Miller include harassing hospital staff by making threatening statements about hospitals and doctors who treat COVID-19 patients and misrepresenting his original 2013 license application. He denied on the application that he was being investigated by another licensing board. At the time, the California Physician Assistant Board was investigating him for providing medical care and prescribing without a supervising doctor’s authorization and without conducting physical exams, among other charges.

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

Background: Some academic medical centers and many community centers use “open” ICU models in which primary services longitudinally follow patients into the ICU with intensivist comanagement.

This is the first qualitative study of hospitalist and intensivist perceptions of the open ICU model. The most significant limitation is the risk of bias from the single-center design and purposive sampling. These findings have implications for other models of medical comanagement.

Bottom line: Open ICU models offer a mix of communication, educational, and structural barriers as well as opportunities. Role clarity may help optimize the open ICU model.

Citation: Santhosh L and Sewell J. Hospital and intensivist experiences of the “open” intensive care unit environment: A qualitative exploration. J Gen Intern Med. 2020;35(8):2338-46.

Dr. Sweigart is a hospitalist at the Lexington (Ky.) VA Health Care System.

Background: Some academic medical centers and many community centers use “open” ICU models in which primary services longitudinally follow patients into the ICU with intensivist comanagement.

This is the first qualitative study of hospitalist and intensivist perceptions of the open ICU model. The most significant limitation is the risk of bias from the single-center design and purposive sampling. These findings have implications for other models of medical comanagement.

Bottom line: Open ICU models offer a mix of communication, educational, and structural barriers as well as opportunities. Role clarity may help optimize the open ICU model.

Citation: Santhosh L and Sewell J. Hospital and intensivist experiences of the “open” intensive care unit environment: A qualitative exploration. J Gen Intern Med. 2020;35(8):2338-46.

Dr. Sweigart is a hospitalist at the Lexington (Ky.) VA Health Care System.

Background: Some academic medical centers and many community centers use “open” ICU models in which primary services longitudinally follow patients into the ICU with intensivist comanagement.

This is the first qualitative study of hospitalist and intensivist perceptions of the open ICU model. The most significant limitation is the risk of bias from the single-center design and purposive sampling. These findings have implications for other models of medical comanagement.

Bottom line: Open ICU models offer a mix of communication, educational, and structural barriers as well as opportunities. Role clarity may help optimize the open ICU model.

Citation: Santhosh L and Sewell J. Hospital and intensivist experiences of the “open” intensive care unit environment: A qualitative exploration. J Gen Intern Med. 2020;35(8):2338-46.

Dr. Sweigart is a hospitalist at the Lexington (Ky.) VA Health Care System.

In patients with unresectable hepatocellular carcinoma (HCC), a single, priming dose of tremelimumab followed by durvalumab showed reduced toxicity, compared with other regimens containing tremelimumab, and the greatest efficacy, compared with durvalumab and tremelimumab as monotherapy or in combination.

The novel regimen featuring a single, priming dose of tremelimumab “displayed the most encouraging benefit-risk profile,” wrote Robin Kate Kelley, MD, of the University of California, San Francisco, and colleagues in the Journal of Clinical Oncology. “These findings suggest that a single dose of tremelimumab may be sufficient to activate the tumor-fighting potential of the immune system.”

The incidence of HCC has been increasing worldwide over the last 20 years. HCC most commonly occurs in people with liver disease, particularly in those with chronic hepatitis B and C and although rare, HCC is the ninth-leading cause of cancer deaths in the United States. The 1-year survival rates in patients with HCC are less than 50%.

Atezolizumab plus bevacizumab gained regulatory approval in 2020 for the treatment of unresectable HCC. Several other immunotherapy-containing regimens are being evaluated, including immune checkpoint inhibitors combined with antiangiogenic agents. Immune checkpoint inhibitors – programmed death–ligand 1 and cytotoxic T-lymphocyte–associated antigen-4 – have shown promise in unresectable HCC, but they are insufficient as single agents and anti–CTLA-4 can be accompanied by challenging toxicities.

In this phase 1/2 study, researchers evaluated tremelimumab (anti–CTLA-4) and durvalumab (anti–PD-L1) as monotherapies and in combination, including a regimen featuring a single, priming dose of tremelimumab and durvalumab followed by durvalumab every 4 weeks. A total of 332 patients with HCC who had progressed on, were intolerant to, or refused sorafenib were randomly assigned to receive one of the four regimens. The primary endpoint was safety.

While the priming doses regimen showed the best benefit-risk profile, all regimens were found to be tolerable and clinically active.

Specifically, in patients on the priming dose, durvalumab, tremelimumab and combination regimes, grade 3 or higher treatment-related adverse events occurred in 37.8%, 20.8%, 43.5%, and 24.4%, respectively. For secondary endpoints, objective response rates were 24.0%, 10.6%, 7.2%, and 9.5%, respectively. The median overall survival was 18.7, 13.6, 15.1, and 11.3 months, respectively.

The priming dose regimen stimulated CD8+ T-cell production, which the authors suggested enhanced response and efficacy.

This novel regimen “may offer distinct differentiating features beyond demonstration of durable objective responses and promising overall survival, including a favorable safety profile with a relatively low steroid requirement, rare [antidrug antibody] formation, and a single, priming dose of tremelimumab followed by monthly durvalumab administration schedule,” the authors wrote. “Moreover, the absence of an antiangiogenic partner allows for treatment of patients who are contraindicated for antiangiogenics because of bleeding risks or comorbidities like cardiovascular disease.”

Another study, recently published in the Journal of Clinical Oncology, showed that donafenib was superior to sorafenib in improving overall survival, along with improved safety and tolerability, rendering it a potential first-line monotherapy for patients with advanced HCC.

The tremelimumab/durvalumab study was funded by AstraZeneca.

In patients with unresectable hepatocellular carcinoma (HCC), a single, priming dose of tremelimumab followed by durvalumab showed reduced toxicity, compared with other regimens containing tremelimumab, and the greatest efficacy, compared with durvalumab and tremelimumab as monotherapy or in combination.

The novel regimen featuring a single, priming dose of tremelimumab “displayed the most encouraging benefit-risk profile,” wrote Robin Kate Kelley, MD, of the University of California, San Francisco, and colleagues in the Journal of Clinical Oncology. “These findings suggest that a single dose of tremelimumab may be sufficient to activate the tumor-fighting potential of the immune system.”

The incidence of HCC has been increasing worldwide over the last 20 years. HCC most commonly occurs in people with liver disease, particularly in those with chronic hepatitis B and C and although rare, HCC is the ninth-leading cause of cancer deaths in the United States. The 1-year survival rates in patients with HCC are less than 50%.

Atezolizumab plus bevacizumab gained regulatory approval in 2020 for the treatment of unresectable HCC. Several other immunotherapy-containing regimens are being evaluated, including immune checkpoint inhibitors combined with antiangiogenic agents. Immune checkpoint inhibitors – programmed death–ligand 1 and cytotoxic T-lymphocyte–associated antigen-4 – have shown promise in unresectable HCC, but they are insufficient as single agents and anti–CTLA-4 can be accompanied by challenging toxicities.

In this phase 1/2 study, researchers evaluated tremelimumab (anti–CTLA-4) and durvalumab (anti–PD-L1) as monotherapies and in combination, including a regimen featuring a single, priming dose of tremelimumab and durvalumab followed by durvalumab every 4 weeks. A total of 332 patients with HCC who had progressed on, were intolerant to, or refused sorafenib were randomly assigned to receive one of the four regimens. The primary endpoint was safety.

While the priming doses regimen showed the best benefit-risk profile, all regimens were found to be tolerable and clinically active.

Specifically, in patients on the priming dose, durvalumab, tremelimumab and combination regimes, grade 3 or higher treatment-related adverse events occurred in 37.8%, 20.8%, 43.5%, and 24.4%, respectively. For secondary endpoints, objective response rates were 24.0%, 10.6%, 7.2%, and 9.5%, respectively. The median overall survival was 18.7, 13.6, 15.1, and 11.3 months, respectively.

The priming dose regimen stimulated CD8+ T-cell production, which the authors suggested enhanced response and efficacy.

This novel regimen “may offer distinct differentiating features beyond demonstration of durable objective responses and promising overall survival, including a favorable safety profile with a relatively low steroid requirement, rare [antidrug antibody] formation, and a single, priming dose of tremelimumab followed by monthly durvalumab administration schedule,” the authors wrote. “Moreover, the absence of an antiangiogenic partner allows for treatment of patients who are contraindicated for antiangiogenics because of bleeding risks or comorbidities like cardiovascular disease.”

Another study, recently published in the Journal of Clinical Oncology, showed that donafenib was superior to sorafenib in improving overall survival, along with improved safety and tolerability, rendering it a potential first-line monotherapy for patients with advanced HCC.

The tremelimumab/durvalumab study was funded by AstraZeneca.

In patients with unresectable hepatocellular carcinoma (HCC), a single, priming dose of tremelimumab followed by durvalumab showed reduced toxicity, compared with other regimens containing tremelimumab, and the greatest efficacy, compared with durvalumab and tremelimumab as monotherapy or in combination.

The novel regimen featuring a single, priming dose of tremelimumab “displayed the most encouraging benefit-risk profile,” wrote Robin Kate Kelley, MD, of the University of California, San Francisco, and colleagues in the Journal of Clinical Oncology. “These findings suggest that a single dose of tremelimumab may be sufficient to activate the tumor-fighting potential of the immune system.”

The incidence of HCC has been increasing worldwide over the last 20 years. HCC most commonly occurs in people with liver disease, particularly in those with chronic hepatitis B and C and although rare, HCC is the ninth-leading cause of cancer deaths in the United States. The 1-year survival rates in patients with HCC are less than 50%.

Atezolizumab plus bevacizumab gained regulatory approval in 2020 for the treatment of unresectable HCC. Several other immunotherapy-containing regimens are being evaluated, including immune checkpoint inhibitors combined with antiangiogenic agents. Immune checkpoint inhibitors – programmed death–ligand 1 and cytotoxic T-lymphocyte–associated antigen-4 – have shown promise in unresectable HCC, but they are insufficient as single agents and anti–CTLA-4 can be accompanied by challenging toxicities.

In this phase 1/2 study, researchers evaluated tremelimumab (anti–CTLA-4) and durvalumab (anti–PD-L1) as monotherapies and in combination, including a regimen featuring a single, priming dose of tremelimumab and durvalumab followed by durvalumab every 4 weeks. A total of 332 patients with HCC who had progressed on, were intolerant to, or refused sorafenib were randomly assigned to receive one of the four regimens. The primary endpoint was safety.

While the priming doses regimen showed the best benefit-risk profile, all regimens were found to be tolerable and clinically active.

Specifically, in patients on the priming dose, durvalumab, tremelimumab and combination regimes, grade 3 or higher treatment-related adverse events occurred in 37.8%, 20.8%, 43.5%, and 24.4%, respectively. For secondary endpoints, objective response rates were 24.0%, 10.6%, 7.2%, and 9.5%, respectively. The median overall survival was 18.7, 13.6, 15.1, and 11.3 months, respectively.

The priming dose regimen stimulated CD8+ T-cell production, which the authors suggested enhanced response and efficacy.

This novel regimen “may offer distinct differentiating features beyond demonstration of durable objective responses and promising overall survival, including a favorable safety profile with a relatively low steroid requirement, rare [antidrug antibody] formation, and a single, priming dose of tremelimumab followed by monthly durvalumab administration schedule,” the authors wrote. “Moreover, the absence of an antiangiogenic partner allows for treatment of patients who are contraindicated for antiangiogenics because of bleeding risks or comorbidities like cardiovascular disease.”

Another study, recently published in the Journal of Clinical Oncology, showed that donafenib was superior to sorafenib in improving overall survival, along with improved safety and tolerability, rendering it a potential first-line monotherapy for patients with advanced HCC.

The tremelimumab/durvalumab study was funded by AstraZeneca.

A rare and potentially life-threatening adverse effect of bronchodilator therapy may be overlooked among patients with chronic obstructive pulmonary disease (COPD) or asthma, according to a researcher who reviewed spirometry test results from U.S. military veterans.

Courtesy of Dr. Kaul

Nearly 1.5% of the tests met the criteria for paradoxical bronchospasm, which refers to airway constriction that may rapidly occur after inhalation of a short-acting beta2 agonist (SABA) such as albuterol.

However, none of those reports alluded to paradoxical bronchospasm, said investigator Malvika Kaul, MD, fellow in the department of pulmonary and critical care at the University of Illinois at Chicago and the Jesse Brown Veterans Affairs Medical Center, also in Chicago.

“Paradoxical bronchospasm was neither recognized nor reported in any spirometry test results,” Dr. Kaul said in an online poster presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.

By recognizing paradoxical bronchospasm, health care providers could address its clinical implications and identify potential alternative management options, according to Dr. Kaul.

“We hope in the future, education of clinicians about this phenomena is emphasized,” Dr. Kaul said in her presentation.
 

Recognizing paradoxical bronchospasm

In an interview, Dr. Kaul said she began researching paradoxical bronchospasm after encountering a patient who had an acute reaction to albuterol during a pulmonary function test.

“I was not taught about it, and I wasn’t recognizing that pattern very frequently in my patients,” she said.

Prescribing information for Food and Drug Administration–approved SABAs include a warning that life-threatening paradoxical bronchospasm may occur, said Dr. Kaul.

If paradoxical bronchospasm occurs, the patient should discontinue the medication immediately and start on alternative therapy, according to the available prescribing information for albuterol sulfate.

Paradoxical bronchospasm has been linked to worsened respiratory outcomes, including more frequent exacerbations, in patients with obstructive lung diseases, according to Dr. Kaul.

Two previous large studies pegged the prevalence of paradoxical bronchospasm at around 4.5% in patients with COPD or asthma, but “it has not been reported or addressed in high-risk population, such as veterans who have high prevalence of obstructive lung diseases like COPD,” Dr. Kaul said.
 

Latest study results

Dr. Kaul described a retrospective analysis of 1,150 pre- and postbronchodilator spirometry tests conducted in patients with COPD or asthma at the Jesse Brown VA Medical Center between 2017 and 2020.

A positive paradoxical bronchodilator response was defined as a decrease of least 12% and 200 mL in forced expiratory volume in 1 second and forced vital capacity from baseline after four puffs of albuterol were inhaled, Dr. Kaul said.

Out of 18 reviewed spirometry results that met the criteria, none of the test results reported or recognized paradoxical bronchospasm, according to Dr. Kaul.

Those meeting the criteria were predominantly COPD patients, according to Dr. Kaul, who said 12 had an underlying diagnosis COPD, 4 had asthma, and 2 had COPD and asthma.

Of the 18 patients, 13 were African American, and all but 1 of the 18 patients had a current or past smoking history, according to reported data.

A history of obstructive sleep apnea was reported in nine patients, and history of gastroesophageal reflux disease was also reported in nine patients. Eleven patients had emphysema.
 

Greater awareness needed

Results of this study emphasize the need to recognize potential cases paradoxical bronchospasm in clinical practice, as well as a need for more research, according to Allen J. Blaivas, DO, FCCP, chair of the CHEST Airway Disorders NetWork.

“It’s something to be on the alert for, and certainly be aware that, if your patient is telling you that they feel worse, we shouldn’t just pooh-pooh it,” said Dr. Blaivas, who is medical director of the intensive care unit at the East Orange campus of the VA New Jersey Health Care System.

Further research could focus on breaking down whether patients with suspected paradoxical bronchospasm are using metered-dose inhalers or nebulizers, whether or not they are also taking inhaled corticosteroids, and whether prospective testing can confirm paradoxical bronchospasm in patients who report tightness after using a SABA, he said in an interview.

Dr. Kaul and coauthor Israel Rubinstein, MD had no relevant relationships to disclose. Dr. Blaivas had no relevant relationships to disclose.

A rare and potentially life-threatening adverse effect of bronchodilator therapy may be overlooked among patients with chronic obstructive pulmonary disease (COPD) or asthma, according to a researcher who reviewed spirometry test results from U.S. military veterans.

Courtesy of Dr. Kaul

Nearly 1.5% of the tests met the criteria for paradoxical bronchospasm, which refers to airway constriction that may rapidly occur after inhalation of a short-acting beta2 agonist (SABA) such as albuterol.

However, none of those reports alluded to paradoxical bronchospasm, said investigator Malvika Kaul, MD, fellow in the department of pulmonary and critical care at the University of Illinois at Chicago and the Jesse Brown Veterans Affairs Medical Center, also in Chicago.

“Paradoxical bronchospasm was neither recognized nor reported in any spirometry test results,” Dr. Kaul said in an online poster presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.

By recognizing paradoxical bronchospasm, health care providers could address its clinical implications and identify potential alternative management options, according to Dr. Kaul.

“We hope in the future, education of clinicians about this phenomena is emphasized,” Dr. Kaul said in her presentation.
 

Recognizing paradoxical bronchospasm

In an interview, Dr. Kaul said she began researching paradoxical bronchospasm after encountering a patient who had an acute reaction to albuterol during a pulmonary function test.

“I was not taught about it, and I wasn’t recognizing that pattern very frequently in my patients,” she said.

Prescribing information for Food and Drug Administration–approved SABAs include a warning that life-threatening paradoxical bronchospasm may occur, said Dr. Kaul.

If paradoxical bronchospasm occurs, the patient should discontinue the medication immediately and start on alternative therapy, according to the available prescribing information for albuterol sulfate.

Paradoxical bronchospasm has been linked to worsened respiratory outcomes, including more frequent exacerbations, in patients with obstructive lung diseases, according to Dr. Kaul.

Two previous large studies pegged the prevalence of paradoxical bronchospasm at around 4.5% in patients with COPD or asthma, but “it has not been reported or addressed in high-risk population, such as veterans who have high prevalence of obstructive lung diseases like COPD,” Dr. Kaul said.
 

Latest study results

Dr. Kaul described a retrospective analysis of 1,150 pre- and postbronchodilator spirometry tests conducted in patients with COPD or asthma at the Jesse Brown VA Medical Center between 2017 and 2020.

A positive paradoxical bronchodilator response was defined as a decrease of least 12% and 200 mL in forced expiratory volume in 1 second and forced vital capacity from baseline after four puffs of albuterol were inhaled, Dr. Kaul said.

Out of 18 reviewed spirometry results that met the criteria, none of the test results reported or recognized paradoxical bronchospasm, according to Dr. Kaul.

Those meeting the criteria were predominantly COPD patients, according to Dr. Kaul, who said 12 had an underlying diagnosis COPD, 4 had asthma, and 2 had COPD and asthma.

Of the 18 patients, 13 were African American, and all but 1 of the 18 patients had a current or past smoking history, according to reported data.

A history of obstructive sleep apnea was reported in nine patients, and history of gastroesophageal reflux disease was also reported in nine patients. Eleven patients had emphysema.
 

Greater awareness needed

Results of this study emphasize the need to recognize potential cases paradoxical bronchospasm in clinical practice, as well as a need for more research, according to Allen J. Blaivas, DO, FCCP, chair of the CHEST Airway Disorders NetWork.

“It’s something to be on the alert for, and certainly be aware that, if your patient is telling you that they feel worse, we shouldn’t just pooh-pooh it,” said Dr. Blaivas, who is medical director of the intensive care unit at the East Orange campus of the VA New Jersey Health Care System.

Further research could focus on breaking down whether patients with suspected paradoxical bronchospasm are using metered-dose inhalers or nebulizers, whether or not they are also taking inhaled corticosteroids, and whether prospective testing can confirm paradoxical bronchospasm in patients who report tightness after using a SABA, he said in an interview.

Dr. Kaul and coauthor Israel Rubinstein, MD had no relevant relationships to disclose. Dr. Blaivas had no relevant relationships to disclose.

A rare and potentially life-threatening adverse effect of bronchodilator therapy may be overlooked among patients with chronic obstructive pulmonary disease (COPD) or asthma, according to a researcher who reviewed spirometry test results from U.S. military veterans.

Courtesy of Dr. Kaul

Nearly 1.5% of the tests met the criteria for paradoxical bronchospasm, which refers to airway constriction that may rapidly occur after inhalation of a short-acting beta2 agonist (SABA) such as albuterol.

However, none of those reports alluded to paradoxical bronchospasm, said investigator Malvika Kaul, MD, fellow in the department of pulmonary and critical care at the University of Illinois at Chicago and the Jesse Brown Veterans Affairs Medical Center, also in Chicago.

“Paradoxical bronchospasm was neither recognized nor reported in any spirometry test results,” Dr. Kaul said in an online poster presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.

By recognizing paradoxical bronchospasm, health care providers could address its clinical implications and identify potential alternative management options, according to Dr. Kaul.

“We hope in the future, education of clinicians about this phenomena is emphasized,” Dr. Kaul said in her presentation.
 

Recognizing paradoxical bronchospasm

In an interview, Dr. Kaul said she began researching paradoxical bronchospasm after encountering a patient who had an acute reaction to albuterol during a pulmonary function test.

“I was not taught about it, and I wasn’t recognizing that pattern very frequently in my patients,” she said.

Prescribing information for Food and Drug Administration–approved SABAs include a warning that life-threatening paradoxical bronchospasm may occur, said Dr. Kaul.

If paradoxical bronchospasm occurs, the patient should discontinue the medication immediately and start on alternative therapy, according to the available prescribing information for albuterol sulfate.

Paradoxical bronchospasm has been linked to worsened respiratory outcomes, including more frequent exacerbations, in patients with obstructive lung diseases, according to Dr. Kaul.

Two previous large studies pegged the prevalence of paradoxical bronchospasm at around 4.5% in patients with COPD or asthma, but “it has not been reported or addressed in high-risk population, such as veterans who have high prevalence of obstructive lung diseases like COPD,” Dr. Kaul said.
 

Latest study results

Dr. Kaul described a retrospective analysis of 1,150 pre- and postbronchodilator spirometry tests conducted in patients with COPD or asthma at the Jesse Brown VA Medical Center between 2017 and 2020.

A positive paradoxical bronchodilator response was defined as a decrease of least 12% and 200 mL in forced expiratory volume in 1 second and forced vital capacity from baseline after four puffs of albuterol were inhaled, Dr. Kaul said.

Out of 18 reviewed spirometry results that met the criteria, none of the test results reported or recognized paradoxical bronchospasm, according to Dr. Kaul.

Those meeting the criteria were predominantly COPD patients, according to Dr. Kaul, who said 12 had an underlying diagnosis COPD, 4 had asthma, and 2 had COPD and asthma.

Of the 18 patients, 13 were African American, and all but 1 of the 18 patients had a current or past smoking history, according to reported data.

A history of obstructive sleep apnea was reported in nine patients, and history of gastroesophageal reflux disease was also reported in nine patients. Eleven patients had emphysema.
 

Greater awareness needed

Results of this study emphasize the need to recognize potential cases paradoxical bronchospasm in clinical practice, as well as a need for more research, according to Allen J. Blaivas, DO, FCCP, chair of the CHEST Airway Disorders NetWork.

“It’s something to be on the alert for, and certainly be aware that, if your patient is telling you that they feel worse, we shouldn’t just pooh-pooh it,” said Dr. Blaivas, who is medical director of the intensive care unit at the East Orange campus of the VA New Jersey Health Care System.

Further research could focus on breaking down whether patients with suspected paradoxical bronchospasm are using metered-dose inhalers or nebulizers, whether or not they are also taking inhaled corticosteroids, and whether prospective testing can confirm paradoxical bronchospasm in patients who report tightness after using a SABA, he said in an interview.

Dr. Kaul and coauthor Israel Rubinstein, MD had no relevant relationships to disclose. Dr. Blaivas had no relevant relationships to disclose.

In this supplement to Dermatology News, Alan Menter, MD discusses best practices for the rare, severe, and chronic autoinflammatory disease known as Generalized Pustular Psoriasis (GPP). 

Read More 

In this supplement to Dermatology News, Alan Menter, MD discusses best practices for the rare, severe, and chronic autoinflammatory disease known as Generalized Pustular Psoriasis (GPP). 

Read More 

In this supplement to Dermatology News, Alan Menter, MD discusses best practices for the rare, severe, and chronic autoinflammatory disease known as Generalized Pustular Psoriasis (GPP). 

Read More 

The first European consensus on vaccination in patients with multiple sclerosis (MS) has been developed by the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the European Academy of Neurology (EAN).

The document, announced at the annual ECTRIMS meeting, proposes a standard for vaccination in patients with MS, including a global vaccination strategy for the general MS patient population and selected subpopulations.

The document does not include any recommendations regarding vaccination against COVID-19, which is the subject of a separate report, announced at the annual meeting. 

The main conclusions in the new report are as follows:

• Vaccinations in general are considered safe for patients with MS and do not modify disease activity/progression.
• Live attenuated vaccines, however, are contraindicated with immunosuppressants.
• Inactivated vaccines can be used safely, but their efficacy may be decreased with immunosuppressants.
• Vaccinations should be considered early in MS management before using immunosuppressants whenever possible.

Presenting the vaccination consensus document, Susana Otero-Romero, MD, from the Multiple Sclerosis Center of Catalonia, Spain, explained that vaccination has become an important part of the risk management strategy in patients with MS treated with highly active drugs but that questions remain as to when and whether to introduce a particular vaccine and which disease-modifying treatments affect vaccine response. 

“The current reference tool has been developed to help professionals to decide on the best vaccination strategy for their patients,” she said.  

The consensus document recommends that, in general, vaccination should be performed at the time of diagnosis of MS or in the early stages of the disease to prevent future delays in starting therapies.

“Ideally, vaccination should take place before the onset of disease-modifying treatment,” Dr. Otero-Romero said. The consensus document recommends inactivated vaccines to be given 2-3 weeks before immunosuppressive therapy is started, and live attenuated vaccines at least 4 weeks beforehand.

In the case of relapse, vaccination should be delayed until clinical resolution or stabilization if possible, the consensus statement recommends.

Serological testing for vaccine-induced antibody titers can be performed 1-2 months after the last dose of the vaccine (suggested for hepatitis B, measles, mumps, and varicella). For attenuated live vaccines, serological tests should be done before starting immunosuppressive therapy. In the case of insufficient response, consideration should be given to administering a booster dose of the vaccine, except for hepatitis B, in which a complete revaccination is recommended, according to the document.

As for vaccination during immunosuppressive therapy, this is considered safe for patients on interferon or glatiramer acetate when indicated, the report says. 

Vaccination should ideally be avoided in patients on dimethyl fumarate, teriflunomide (Aubagio) or natalizumab (Tysabri), although it can be considered in exceptional cases when the potential risk of acquiring the infection is greater than the risk of developing vaccine-related infections (unless the absolute lymphocyte count is below 800/mm³), it adds.

Vaccination should be avoided in patients on S1P modulators (for example, fingolimod [Gilenya]), anti-CD20 therapies, and before immune restoration for cladribine (Leustatin) and alemtuzumab (Lemtrada).

In the case of patients stopping immunosuppressive therapy, inactivated vaccines can be given any time after the discontinuation of therapy but preferably after immune restoration. Live attenuated vaccines should only be administered after a safety interval ensures immune restoration has been met.
 

Which vaccines?

On which vaccines are needed in patients with MS, the consensus document recommends the same routine vaccination schedule as for the general population. In addition, it advises influenza and pneumococcal vaccination if patients are immunosuppressed or have significant disability.

It also recommends human papillomavirus vaccine in women and men independent of their age if they are to be treated with alemtuzumab, fingolimod, cladribine, or anti-CD20 drugs. Hepatitis B vaccination is also advised in patients treated with anti-CD20 drugs.
 

Special populations: pregnancy/elderly

In patients with MS who are pregnant, inactivated flu vaccine can be given in any trimester at the start of the flu season, and vaccination against diphtheria, tetanus, and pertussis can be given during the third trimester, the report says. Live attenuated vaccines should be completed at least 1 month before pregnancy or after delivery and 4-6 weeks prior to the initiation of immunosuppressive therapy.

Elderly patients with MS should receive flu and pneumococcal vaccines annually and would also benefit from the inactivated herpes zoster vaccine.
 

Travel vaccines

On vaccinations needed for travel, the report recommends that patients with MS consult a specialized travel clinic or vaccination expert and start immunizations 2-3 months before departure. Patients with MS with or without immunosuppressive therapy can receive hepatitis A, rabies, Japanese encephalitis, tic-borne encephalitis, polio, and inactivated typhoid vaccine. But yellow fever and oral typhoid are contraindicated in patients on immunosuppressive therapies.

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

The first European consensus on vaccination in patients with multiple sclerosis (MS) has been developed by the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the European Academy of Neurology (EAN).

The document, announced at the annual ECTRIMS meeting, proposes a standard for vaccination in patients with MS, including a global vaccination strategy for the general MS patient population and selected subpopulations.

The document does not include any recommendations regarding vaccination against COVID-19, which is the subject of a separate report, announced at the annual meeting. 

The main conclusions in the new report are as follows:

• Vaccinations in general are considered safe for patients with MS and do not modify disease activity/progression.
• Live attenuated vaccines, however, are contraindicated with immunosuppressants.
• Inactivated vaccines can be used safely, but their efficacy may be decreased with immunosuppressants.
• Vaccinations should be considered early in MS management before using immunosuppressants whenever possible.

Presenting the vaccination consensus document, Susana Otero-Romero, MD, from the Multiple Sclerosis Center of Catalonia, Spain, explained that vaccination has become an important part of the risk management strategy in patients with MS treated with highly active drugs but that questions remain as to when and whether to introduce a particular vaccine and which disease-modifying treatments affect vaccine response. 

“The current reference tool has been developed to help professionals to decide on the best vaccination strategy for their patients,” she said.  

The consensus document recommends that, in general, vaccination should be performed at the time of diagnosis of MS or in the early stages of the disease to prevent future delays in starting therapies.

“Ideally, vaccination should take place before the onset of disease-modifying treatment,” Dr. Otero-Romero said. The consensus document recommends inactivated vaccines to be given 2-3 weeks before immunosuppressive therapy is started, and live attenuated vaccines at least 4 weeks beforehand.

In the case of relapse, vaccination should be delayed until clinical resolution or stabilization if possible, the consensus statement recommends.

Serological testing for vaccine-induced antibody titers can be performed 1-2 months after the last dose of the vaccine (suggested for hepatitis B, measles, mumps, and varicella). For attenuated live vaccines, serological tests should be done before starting immunosuppressive therapy. In the case of insufficient response, consideration should be given to administering a booster dose of the vaccine, except for hepatitis B, in which a complete revaccination is recommended, according to the document.

As for vaccination during immunosuppressive therapy, this is considered safe for patients on interferon or glatiramer acetate when indicated, the report says. 

Vaccination should ideally be avoided in patients on dimethyl fumarate, teriflunomide (Aubagio) or natalizumab (Tysabri), although it can be considered in exceptional cases when the potential risk of acquiring the infection is greater than the risk of developing vaccine-related infections (unless the absolute lymphocyte count is below 800/mm³), it adds.

Vaccination should be avoided in patients on S1P modulators (for example, fingolimod [Gilenya]), anti-CD20 therapies, and before immune restoration for cladribine (Leustatin) and alemtuzumab (Lemtrada).

In the case of patients stopping immunosuppressive therapy, inactivated vaccines can be given any time after the discontinuation of therapy but preferably after immune restoration. Live attenuated vaccines should only be administered after a safety interval ensures immune restoration has been met.
 

Which vaccines?

On which vaccines are needed in patients with MS, the consensus document recommends the same routine vaccination schedule as for the general population. In addition, it advises influenza and pneumococcal vaccination if patients are immunosuppressed or have significant disability.

It also recommends human papillomavirus vaccine in women and men independent of their age if they are to be treated with alemtuzumab, fingolimod, cladribine, or anti-CD20 drugs. Hepatitis B vaccination is also advised in patients treated with anti-CD20 drugs.
 

Special populations: pregnancy/elderly

In patients with MS who are pregnant, inactivated flu vaccine can be given in any trimester at the start of the flu season, and vaccination against diphtheria, tetanus, and pertussis can be given during the third trimester, the report says. Live attenuated vaccines should be completed at least 1 month before pregnancy or after delivery and 4-6 weeks prior to the initiation of immunosuppressive therapy.

Elderly patients with MS should receive flu and pneumococcal vaccines annually and would also benefit from the inactivated herpes zoster vaccine.
 

Travel vaccines

On vaccinations needed for travel, the report recommends that patients with MS consult a specialized travel clinic or vaccination expert and start immunizations 2-3 months before departure. Patients with MS with or without immunosuppressive therapy can receive hepatitis A, rabies, Japanese encephalitis, tic-borne encephalitis, polio, and inactivated typhoid vaccine. But yellow fever and oral typhoid are contraindicated in patients on immunosuppressive therapies.

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

The first European consensus on vaccination in patients with multiple sclerosis (MS) has been developed by the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the European Academy of Neurology (EAN).

The document, announced at the annual ECTRIMS meeting, proposes a standard for vaccination in patients with MS, including a global vaccination strategy for the general MS patient population and selected subpopulations.

The document does not include any recommendations regarding vaccination against COVID-19, which is the subject of a separate report, announced at the annual meeting. 

The main conclusions in the new report are as follows:

• Vaccinations in general are considered safe for patients with MS and do not modify disease activity/progression.
• Live attenuated vaccines, however, are contraindicated with immunosuppressants.
• Inactivated vaccines can be used safely, but their efficacy may be decreased with immunosuppressants.
• Vaccinations should be considered early in MS management before using immunosuppressants whenever possible.

Presenting the vaccination consensus document, Susana Otero-Romero, MD, from the Multiple Sclerosis Center of Catalonia, Spain, explained that vaccination has become an important part of the risk management strategy in patients with MS treated with highly active drugs but that questions remain as to when and whether to introduce a particular vaccine and which disease-modifying treatments affect vaccine response. 

“The current reference tool has been developed to help professionals to decide on the best vaccination strategy for their patients,” she said.  

The consensus document recommends that, in general, vaccination should be performed at the time of diagnosis of MS or in the early stages of the disease to prevent future delays in starting therapies.

“Ideally, vaccination should take place before the onset of disease-modifying treatment,” Dr. Otero-Romero said. The consensus document recommends inactivated vaccines to be given 2-3 weeks before immunosuppressive therapy is started, and live attenuated vaccines at least 4 weeks beforehand.

In the case of relapse, vaccination should be delayed until clinical resolution or stabilization if possible, the consensus statement recommends.

Serological testing for vaccine-induced antibody titers can be performed 1-2 months after the last dose of the vaccine (suggested for hepatitis B, measles, mumps, and varicella). For attenuated live vaccines, serological tests should be done before starting immunosuppressive therapy. In the case of insufficient response, consideration should be given to administering a booster dose of the vaccine, except for hepatitis B, in which a complete revaccination is recommended, according to the document.

As for vaccination during immunosuppressive therapy, this is considered safe for patients on interferon or glatiramer acetate when indicated, the report says. 

Vaccination should ideally be avoided in patients on dimethyl fumarate, teriflunomide (Aubagio) or natalizumab (Tysabri), although it can be considered in exceptional cases when the potential risk of acquiring the infection is greater than the risk of developing vaccine-related infections (unless the absolute lymphocyte count is below 800/mm³), it adds.

Vaccination should be avoided in patients on S1P modulators (for example, fingolimod [Gilenya]), anti-CD20 therapies, and before immune restoration for cladribine (Leustatin) and alemtuzumab (Lemtrada).

In the case of patients stopping immunosuppressive therapy, inactivated vaccines can be given any time after the discontinuation of therapy but preferably after immune restoration. Live attenuated vaccines should only be administered after a safety interval ensures immune restoration has been met.
 

Which vaccines?

On which vaccines are needed in patients with MS, the consensus document recommends the same routine vaccination schedule as for the general population. In addition, it advises influenza and pneumococcal vaccination if patients are immunosuppressed or have significant disability.

It also recommends human papillomavirus vaccine in women and men independent of their age if they are to be treated with alemtuzumab, fingolimod, cladribine, or anti-CD20 drugs. Hepatitis B vaccination is also advised in patients treated with anti-CD20 drugs.
 

Special populations: pregnancy/elderly

In patients with MS who are pregnant, inactivated flu vaccine can be given in any trimester at the start of the flu season, and vaccination against diphtheria, tetanus, and pertussis can be given during the third trimester, the report says. Live attenuated vaccines should be completed at least 1 month before pregnancy or after delivery and 4-6 weeks prior to the initiation of immunosuppressive therapy.

Elderly patients with MS should receive flu and pneumococcal vaccines annually and would also benefit from the inactivated herpes zoster vaccine.
 

Travel vaccines

On vaccinations needed for travel, the report recommends that patients with MS consult a specialized travel clinic or vaccination expert and start immunizations 2-3 months before departure. Patients with MS with or without immunosuppressive therapy can receive hepatitis A, rabies, Japanese encephalitis, tic-borne encephalitis, polio, and inactivated typhoid vaccine. But yellow fever and oral typhoid are contraindicated in patients on immunosuppressive therapies.

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

ANSWER

All of these items were rightly considered to be in the differential for this lesion, so the answer is choice “f.”

DISCUSSION

Individuals with type IV skin are less likely than those with types II and III to develop skin cancer. So, although cancer was definitely in the differential, the other items were considered just as, if not more, likely in this case.

The only way to sort through these diagnostic possibilities was to perform a biopsy. In this case, the entire lesion was removed by saucerization technique, under local anesthesia. The specimen provided would be adequate to detect any cancer, which a smaller specimen could easily miss.

The pathology results showed pigmented basal cell carcinoma. Given the patient’s extensive history of sun exposure, and the steady growth of the lesion, this was hardly a surprise. But prior to the biopsy, one could just as easily imagine the lesion to be, for example, a wart.

The take-home message is obvious: Nothing can take the place of biopsy in establishing a precise diagnosis. With that information in hand, the patient was referred for consultation with a Mohs surgeon. Surgical removal and closure would likely set him back several thousand dollars and leave a considerable scar.

ANSWER

All of these items were rightly considered to be in the differential for this lesion, so the answer is choice “f.”

DISCUSSION

Individuals with type IV skin are less likely than those with types II and III to develop skin cancer. So, although cancer was definitely in the differential, the other items were considered just as, if not more, likely in this case.

The only way to sort through these diagnostic possibilities was to perform a biopsy. In this case, the entire lesion was removed by saucerization technique, under local anesthesia. The specimen provided would be adequate to detect any cancer, which a smaller specimen could easily miss.

The pathology results showed pigmented basal cell carcinoma. Given the patient’s extensive history of sun exposure, and the steady growth of the lesion, this was hardly a surprise. But prior to the biopsy, one could just as easily imagine the lesion to be, for example, a wart.

The take-home message is obvious: Nothing can take the place of biopsy in establishing a precise diagnosis. With that information in hand, the patient was referred for consultation with a Mohs surgeon. Surgical removal and closure would likely set him back several thousand dollars and leave a considerable scar.

ANSWER

All of these items were rightly considered to be in the differential for this lesion, so the answer is choice “f.”

DISCUSSION

Individuals with type IV skin are less likely than those with types II and III to develop skin cancer. So, although cancer was definitely in the differential, the other items were considered just as, if not more, likely in this case.

The only way to sort through these diagnostic possibilities was to perform a biopsy. In this case, the entire lesion was removed by saucerization technique, under local anesthesia. The specimen provided would be adequate to detect any cancer, which a smaller specimen could easily miss.

The pathology results showed pigmented basal cell carcinoma. Given the patient’s extensive history of sun exposure, and the steady growth of the lesion, this was hardly a surprise. But prior to the biopsy, one could just as easily imagine the lesion to be, for example, a wart.

The take-home message is obvious: Nothing can take the place of biopsy in establishing a precise diagnosis. With that information in hand, the patient was referred for consultation with a Mohs surgeon. Surgical removal and closure would likely set him back several thousand dollars and leave a considerable scar.

For patients with refractory acute respiratory distress syndrome (ARDS) caused by COVID-19 infections, extracorporeal membrane oxygenation (ECMO) may be the treatment of last resort.

But for reasons that aren’t clear, in the second wave of the COVID-19 pandemic at a major teaching hospital, the mortality rate of patients on ECMO for COVID-induced ARDS was significantly higher than it was during the first wave, despite changes in drug therapy and clinical management, reported Rohit Reddy, BS, a second-year medical student, and colleagues at Thomas Jefferson University Hospital in Philadelphia.

During the first wave, from April to September 2020, the survival rate of patients while on ECMO in their ICUs was 67%. In contrast, for patients treated during the second wave, from November 2020 to March 2021, the ECMO survival rate was 31% (P = .003).

The 30-day survival rates were also higher in the first wave compared with the second, at 54% versus 31%, but this difference was not statistically significant.

“More research is required to develop stricter inclusion/exclusion criteria and to improve pre-ECMO management in order to improve outcomes,” Mr. Reddy said in a narrated poster presented at the annual meeting of the American College of Chest Physicians, held virtually this year.
 

ARDS severity higher

ARDS is a major complication of COVID-19 infections, and there is evidence to suggest that COVID-associated ARDS is more severe than ARDS caused by other causes, the investigators noted.

“ECMO, which has been used as a rescue therapy in prior viral outbreaks, has been used to support certain patients with refractory ARDS due to COVID-19, but evidence for its efficacy is limited. Respiratory failure remained a highly concerning complication in the second wave of the COVID-19 pandemic, but it is unclear how the evolution of the disease and pharmacologic utility has affected the clinical utility of ECMO,” Mr. Reddy said.

To see whether changes in disease course or in treatment could explain changes in outcomes for patients with COVID-related ARDS, the investigators compared characteristics and outcomes for patients treated in the first versus second waves of the pandemic. Their study did not include data from patients infected with the Delta variant of the SARS-CoV-2 virus, which became the predominant viral strain later in 2021.

The study included data on 28 patients treated during the first wave, and 13 during the second. The sample included 28 men and 13 women with a mean age of 51 years.

All patients had venovenous ECMO, with cannulation in the femoral or internal jugular veins; some patients received ECMO via a single double-lumen cannula.

There were no significant differences between the two time periods in patient comorbidities prior to initiation of ECMO.

Patients in the second wave were significantly more likely to receive steroids (54% vs. 100%; P = .003) and remdesivir (39% vs. 85%; P = .007). Prone positioning before ECMO was also significantly more frequent in the second wave (11% vs. 85%; P < .001).

Patients in the second wave stayed on ECMO longer – median 20 days versus 14 days for first-wave patients – but as noted before, ECMO mortality rates were significantly higher during the second wave. During the first wave, 33% of patients died while on ECMO, compared with 69% in the second wave (P = .03). Respective 30-day mortality rates were 46% versus 69% (ns).

Rates of complications during ECMO were generally comparable between the groups, including acute renal failure (39% in the first wave vs 38% in the second), sepsis (32% vs. 23%), bacterial pneumonia (11% vs. 8%), and gastrointestinal bleeding (21% vs. 15%). However, significantly more patients in the second wave had cerebral vascular accidents (4% vs. 23%; P = .050).

Senior author Hitoshi Hirose, MD, PhD, professor of surgery at Thomas Jefferson University, said in an interview that the difference in outcomes was likely caused by changes in pre-ECMO therapy between the first and second waves.

“Our study showed the incidence of sepsis had a large impact on the patient outcomes,” he wrote. “We speculate that sepsis was attributed to use of immune modulation therapy. The prevention of the sepsis would be key to improve survival of ECMO for COVID 19.”

“It’s possible that the explanation for this is that patients in the second wave were sicker in a way that wasn’t adequately measured in the first wave,” CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center in Hartford, said in an interview.

The differences may also have been attributable to changes in virulence, or to clinical decisions to put sicker patients on ECMO, he said.

Casey Cable, MD, MSc, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center in Richmond, also speculated in an interview that second-wave patients may have been sicker.

“One interesting piece of this story is that we now know a lot more – we know about the use of steroids plus or minus remdesivir and proning, and patients received a large majority of those treatments but still got put on ECMO,” she said. “I wonder if there is a subset of really sick patients, and no matter what we treat with – steroids, proning – whatever we do they’re just not going to do well.”

Both Dr. Carroll and Dr. Cable emphasized the importance of ECMO as a rescue therapy for patients with severe, refractory ARDS associated with COVID-19 or other diseases.

Neither Dr. Carroll nor Dr. Cable were involved in the study.

No study funding was reported. Mr. Reddy, Dr. Hirose, Dr. Carroll, and Dr. Cable disclosed no relevant financial relationships.

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

For patients with refractory acute respiratory distress syndrome (ARDS) caused by COVID-19 infections, extracorporeal membrane oxygenation (ECMO) may be the treatment of last resort.

But for reasons that aren’t clear, in the second wave of the COVID-19 pandemic at a major teaching hospital, the mortality rate of patients on ECMO for COVID-induced ARDS was significantly higher than it was during the first wave, despite changes in drug therapy and clinical management, reported Rohit Reddy, BS, a second-year medical student, and colleagues at Thomas Jefferson University Hospital in Philadelphia.

During the first wave, from April to September 2020, the survival rate of patients while on ECMO in their ICUs was 67%. In contrast, for patients treated during the second wave, from November 2020 to March 2021, the ECMO survival rate was 31% (P = .003).

The 30-day survival rates were also higher in the first wave compared with the second, at 54% versus 31%, but this difference was not statistically significant.

“More research is required to develop stricter inclusion/exclusion criteria and to improve pre-ECMO management in order to improve outcomes,” Mr. Reddy said in a narrated poster presented at the annual meeting of the American College of Chest Physicians, held virtually this year.
 

ARDS severity higher

ARDS is a major complication of COVID-19 infections, and there is evidence to suggest that COVID-associated ARDS is more severe than ARDS caused by other causes, the investigators noted.

“ECMO, which has been used as a rescue therapy in prior viral outbreaks, has been used to support certain patients with refractory ARDS due to COVID-19, but evidence for its efficacy is limited. Respiratory failure remained a highly concerning complication in the second wave of the COVID-19 pandemic, but it is unclear how the evolution of the disease and pharmacologic utility has affected the clinical utility of ECMO,” Mr. Reddy said.

To see whether changes in disease course or in treatment could explain changes in outcomes for patients with COVID-related ARDS, the investigators compared characteristics and outcomes for patients treated in the first versus second waves of the pandemic. Their study did not include data from patients infected with the Delta variant of the SARS-CoV-2 virus, which became the predominant viral strain later in 2021.

The study included data on 28 patients treated during the first wave, and 13 during the second. The sample included 28 men and 13 women with a mean age of 51 years.

All patients had venovenous ECMO, with cannulation in the femoral or internal jugular veins; some patients received ECMO via a single double-lumen cannula.

There were no significant differences between the two time periods in patient comorbidities prior to initiation of ECMO.

Patients in the second wave were significantly more likely to receive steroids (54% vs. 100%; P = .003) and remdesivir (39% vs. 85%; P = .007). Prone positioning before ECMO was also significantly more frequent in the second wave (11% vs. 85%; P < .001).

Patients in the second wave stayed on ECMO longer – median 20 days versus 14 days for first-wave patients – but as noted before, ECMO mortality rates were significantly higher during the second wave. During the first wave, 33% of patients died while on ECMO, compared with 69% in the second wave (P = .03). Respective 30-day mortality rates were 46% versus 69% (ns).

Rates of complications during ECMO were generally comparable between the groups, including acute renal failure (39% in the first wave vs 38% in the second), sepsis (32% vs. 23%), bacterial pneumonia (11% vs. 8%), and gastrointestinal bleeding (21% vs. 15%). However, significantly more patients in the second wave had cerebral vascular accidents (4% vs. 23%; P = .050).

Senior author Hitoshi Hirose, MD, PhD, professor of surgery at Thomas Jefferson University, said in an interview that the difference in outcomes was likely caused by changes in pre-ECMO therapy between the first and second waves.

“Our study showed the incidence of sepsis had a large impact on the patient outcomes,” he wrote. “We speculate that sepsis was attributed to use of immune modulation therapy. The prevention of the sepsis would be key to improve survival of ECMO for COVID 19.”

“It’s possible that the explanation for this is that patients in the second wave were sicker in a way that wasn’t adequately measured in the first wave,” CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center in Hartford, said in an interview.

The differences may also have been attributable to changes in virulence, or to clinical decisions to put sicker patients on ECMO, he said.

Casey Cable, MD, MSc, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center in Richmond, also speculated in an interview that second-wave patients may have been sicker.

“One interesting piece of this story is that we now know a lot more – we know about the use of steroids plus or minus remdesivir and proning, and patients received a large majority of those treatments but still got put on ECMO,” she said. “I wonder if there is a subset of really sick patients, and no matter what we treat with – steroids, proning – whatever we do they’re just not going to do well.”

Both Dr. Carroll and Dr. Cable emphasized the importance of ECMO as a rescue therapy for patients with severe, refractory ARDS associated with COVID-19 or other diseases.

Neither Dr. Carroll nor Dr. Cable were involved in the study.

No study funding was reported. Mr. Reddy, Dr. Hirose, Dr. Carroll, and Dr. Cable disclosed no relevant financial relationships.

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

For patients with refractory acute respiratory distress syndrome (ARDS) caused by COVID-19 infections, extracorporeal membrane oxygenation (ECMO) may be the treatment of last resort.

But for reasons that aren’t clear, in the second wave of the COVID-19 pandemic at a major teaching hospital, the mortality rate of patients on ECMO for COVID-induced ARDS was significantly higher than it was during the first wave, despite changes in drug therapy and clinical management, reported Rohit Reddy, BS, a second-year medical student, and colleagues at Thomas Jefferson University Hospital in Philadelphia.

During the first wave, from April to September 2020, the survival rate of patients while on ECMO in their ICUs was 67%. In contrast, for patients treated during the second wave, from November 2020 to March 2021, the ECMO survival rate was 31% (P = .003).

The 30-day survival rates were also higher in the first wave compared with the second, at 54% versus 31%, but this difference was not statistically significant.

“More research is required to develop stricter inclusion/exclusion criteria and to improve pre-ECMO management in order to improve outcomes,” Mr. Reddy said in a narrated poster presented at the annual meeting of the American College of Chest Physicians, held virtually this year.
 

ARDS severity higher

ARDS is a major complication of COVID-19 infections, and there is evidence to suggest that COVID-associated ARDS is more severe than ARDS caused by other causes, the investigators noted.

“ECMO, which has been used as a rescue therapy in prior viral outbreaks, has been used to support certain patients with refractory ARDS due to COVID-19, but evidence for its efficacy is limited. Respiratory failure remained a highly concerning complication in the second wave of the COVID-19 pandemic, but it is unclear how the evolution of the disease and pharmacologic utility has affected the clinical utility of ECMO,” Mr. Reddy said.

To see whether changes in disease course or in treatment could explain changes in outcomes for patients with COVID-related ARDS, the investigators compared characteristics and outcomes for patients treated in the first versus second waves of the pandemic. Their study did not include data from patients infected with the Delta variant of the SARS-CoV-2 virus, which became the predominant viral strain later in 2021.

The study included data on 28 patients treated during the first wave, and 13 during the second. The sample included 28 men and 13 women with a mean age of 51 years.

All patients had venovenous ECMO, with cannulation in the femoral or internal jugular veins; some patients received ECMO via a single double-lumen cannula.

There were no significant differences between the two time periods in patient comorbidities prior to initiation of ECMO.

Patients in the second wave were significantly more likely to receive steroids (54% vs. 100%; P = .003) and remdesivir (39% vs. 85%; P = .007). Prone positioning before ECMO was also significantly more frequent in the second wave (11% vs. 85%; P < .001).

Patients in the second wave stayed on ECMO longer – median 20 days versus 14 days for first-wave patients – but as noted before, ECMO mortality rates were significantly higher during the second wave. During the first wave, 33% of patients died while on ECMO, compared with 69% in the second wave (P = .03). Respective 30-day mortality rates were 46% versus 69% (ns).

Rates of complications during ECMO were generally comparable between the groups, including acute renal failure (39% in the first wave vs 38% in the second), sepsis (32% vs. 23%), bacterial pneumonia (11% vs. 8%), and gastrointestinal bleeding (21% vs. 15%). However, significantly more patients in the second wave had cerebral vascular accidents (4% vs. 23%; P = .050).

Senior author Hitoshi Hirose, MD, PhD, professor of surgery at Thomas Jefferson University, said in an interview that the difference in outcomes was likely caused by changes in pre-ECMO therapy between the first and second waves.

“Our study showed the incidence of sepsis had a large impact on the patient outcomes,” he wrote. “We speculate that sepsis was attributed to use of immune modulation therapy. The prevention of the sepsis would be key to improve survival of ECMO for COVID 19.”

“It’s possible that the explanation for this is that patients in the second wave were sicker in a way that wasn’t adequately measured in the first wave,” CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center in Hartford, said in an interview.

The differences may also have been attributable to changes in virulence, or to clinical decisions to put sicker patients on ECMO, he said.

Casey Cable, MD, MSc, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center in Richmond, also speculated in an interview that second-wave patients may have been sicker.

“One interesting piece of this story is that we now know a lot more – we know about the use of steroids plus or minus remdesivir and proning, and patients received a large majority of those treatments but still got put on ECMO,” she said. “I wonder if there is a subset of really sick patients, and no matter what we treat with – steroids, proning – whatever we do they’re just not going to do well.”

Both Dr. Carroll and Dr. Cable emphasized the importance of ECMO as a rescue therapy for patients with severe, refractory ARDS associated with COVID-19 or other diseases.

Neither Dr. Carroll nor Dr. Cable were involved in the study.

No study funding was reported. Mr. Reddy, Dr. Hirose, Dr. Carroll, and Dr. Cable disclosed no relevant financial relationships.

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