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Reports suggest possible in utero transmission of novel coronavirus 2019
Reports of three neonates with elevated IgM antibody concentrations whose mothers had COVID-19 in two articles raise questions about whether the infants may have been infected with the virus in utero.
The data, while provocative, “are not conclusive and do not prove in utero transmission” of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), editorialists cautioned.
“The suggestion of in utero transmission rests on IgM detection in these 3 neonates, and IgM is a challenging way to diagnose many congenital infections,” David W. Kimberlin, MD, and Sergio Stagno, MD, of the division of pediatric infectious diseases at University of Alabama at Birmingham, wrote in their editorial. “IgM antibodies are too large to cross the placenta and so detection in a newborn reasonably could be assumed to reflect fetal production following in utero infection. However, most congenital infections are not diagnosed based on IgM detection because IgM assays can be prone to false-positive and false-negative results, along with cross-reactivity and testing challenges.”
None of the three infants had a positive reverse transcriptase–polymerase chain reaction (RT-PCR) test result, “so there is not virologic evidence for congenital infection in these cases to support the serologic suggestion of in utero transmission,” the editorialists noted.
Examining the possibility of vertical transmission
A prior case series of nine pregnant women found no transmission of the virus from mother to child, but the question of in utero transmission is not settled, said Lan Dong, MD, of the department of obstetrics and gynecology at Renmin Hospital of Wuhan University in China and colleagues. In their research letter, the investigators described a newborn with elevated IgM antibodies to novel coronavirus 2019 born to a mother with COVID-19. The infant was delivered by cesarean section February 22, 2020, at Renmin Hospital in a negative-pressure isolation room.
“The mother wore an N95 mask and did not hold the infant,” the researchers said. “The neonate had no symptoms and was immediately quarantined in the neonatal intensive care unit. At 2 hours of age, the SARS-CoV-2 IgG level was 140.32 AU/mL and the IgM level was 45.83 AU/mL.” Although the infant may have been infected at delivery, IgM antibodies usually take days to appear, Dr. Dong and colleagues wrote. “The infant’s repeatedly negative RT-PCR test results on nasopharyngeal swabs are difficult to explain, although these tests are not always positive with infection. ... Additional examination of maternal and newborn samples should be done to confirm this preliminary observation.”
A review of infants’ serologic characteristics
Hui Zeng, MD, of the department of laboratory medicine at Zhongnan Hospital of Wuhan University in China and colleagues retrospectively reviewed clinical records and laboratory results for six pregnant women with COVID-19, according to a study in JAMA. The women had mild clinical manifestations and were admitted to Zhongnan Hospital between February 16 and March 6. “All had cesarean deliveries in their third trimester in negative pressure isolation rooms,” the investigators said. “All mothers wore masks, and all medical staff wore protective suits and double masks. The infants were isolated from their mothers immediately after delivery.”
Two of the infants had elevated IgG and IgM concentrations. IgM “is not usually transferred from mother to fetus because of its larger macromolecular structure. ... Whether the placentas of women in this study were damaged and abnormal is unknown,” Dr. Zeng and colleagues said. “Alternatively, IgM could have been produced by the infant if the virus crossed the placenta.”
“Although these 2 studies deserve careful evaluation, more definitive evidence is needed” before physicians can “counsel pregnant women that their fetuses are at risk from congenital infection with SARS-CoV-2,” Dr. Kimberlin and Dr. Stagno concluded.
Dr. Dong and associates had no conflicts of interest. Their work was supported by the National Key Research and Development Project and others. Dr. Zeng and colleagues had no relevant financial disclosures. Their study was supported by grants from the National Natural Science Foundation of China and Zhongnan Hospital. Dr. Kimberlin and Dr. Stagno had no conflicts of interest.
SOURCE: Dong L et al. JAMA. 2020 Mar 26. doi: 10.1001/jama.2020.4621; Zeng H et al. JAMA. 2020 Mar 26. doi: 10.1001/jama.2020.4861.
Reports of three neonates with elevated IgM antibody concentrations whose mothers had COVID-19 in two articles raise questions about whether the infants may have been infected with the virus in utero.
The data, while provocative, “are not conclusive and do not prove in utero transmission” of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), editorialists cautioned.
“The suggestion of in utero transmission rests on IgM detection in these 3 neonates, and IgM is a challenging way to diagnose many congenital infections,” David W. Kimberlin, MD, and Sergio Stagno, MD, of the division of pediatric infectious diseases at University of Alabama at Birmingham, wrote in their editorial. “IgM antibodies are too large to cross the placenta and so detection in a newborn reasonably could be assumed to reflect fetal production following in utero infection. However, most congenital infections are not diagnosed based on IgM detection because IgM assays can be prone to false-positive and false-negative results, along with cross-reactivity and testing challenges.”
None of the three infants had a positive reverse transcriptase–polymerase chain reaction (RT-PCR) test result, “so there is not virologic evidence for congenital infection in these cases to support the serologic suggestion of in utero transmission,” the editorialists noted.
Examining the possibility of vertical transmission
A prior case series of nine pregnant women found no transmission of the virus from mother to child, but the question of in utero transmission is not settled, said Lan Dong, MD, of the department of obstetrics and gynecology at Renmin Hospital of Wuhan University in China and colleagues. In their research letter, the investigators described a newborn with elevated IgM antibodies to novel coronavirus 2019 born to a mother with COVID-19. The infant was delivered by cesarean section February 22, 2020, at Renmin Hospital in a negative-pressure isolation room.
“The mother wore an N95 mask and did not hold the infant,” the researchers said. “The neonate had no symptoms and was immediately quarantined in the neonatal intensive care unit. At 2 hours of age, the SARS-CoV-2 IgG level was 140.32 AU/mL and the IgM level was 45.83 AU/mL.” Although the infant may have been infected at delivery, IgM antibodies usually take days to appear, Dr. Dong and colleagues wrote. “The infant’s repeatedly negative RT-PCR test results on nasopharyngeal swabs are difficult to explain, although these tests are not always positive with infection. ... Additional examination of maternal and newborn samples should be done to confirm this preliminary observation.”
A review of infants’ serologic characteristics
Hui Zeng, MD, of the department of laboratory medicine at Zhongnan Hospital of Wuhan University in China and colleagues retrospectively reviewed clinical records and laboratory results for six pregnant women with COVID-19, according to a study in JAMA. The women had mild clinical manifestations and were admitted to Zhongnan Hospital between February 16 and March 6. “All had cesarean deliveries in their third trimester in negative pressure isolation rooms,” the investigators said. “All mothers wore masks, and all medical staff wore protective suits and double masks. The infants were isolated from their mothers immediately after delivery.”
Two of the infants had elevated IgG and IgM concentrations. IgM “is not usually transferred from mother to fetus because of its larger macromolecular structure. ... Whether the placentas of women in this study were damaged and abnormal is unknown,” Dr. Zeng and colleagues said. “Alternatively, IgM could have been produced by the infant if the virus crossed the placenta.”
“Although these 2 studies deserve careful evaluation, more definitive evidence is needed” before physicians can “counsel pregnant women that their fetuses are at risk from congenital infection with SARS-CoV-2,” Dr. Kimberlin and Dr. Stagno concluded.
Dr. Dong and associates had no conflicts of interest. Their work was supported by the National Key Research and Development Project and others. Dr. Zeng and colleagues had no relevant financial disclosures. Their study was supported by grants from the National Natural Science Foundation of China and Zhongnan Hospital. Dr. Kimberlin and Dr. Stagno had no conflicts of interest.
SOURCE: Dong L et al. JAMA. 2020 Mar 26. doi: 10.1001/jama.2020.4621; Zeng H et al. JAMA. 2020 Mar 26. doi: 10.1001/jama.2020.4861.
Reports of three neonates with elevated IgM antibody concentrations whose mothers had COVID-19 in two articles raise questions about whether the infants may have been infected with the virus in utero.
The data, while provocative, “are not conclusive and do not prove in utero transmission” of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), editorialists cautioned.
“The suggestion of in utero transmission rests on IgM detection in these 3 neonates, and IgM is a challenging way to diagnose many congenital infections,” David W. Kimberlin, MD, and Sergio Stagno, MD, of the division of pediatric infectious diseases at University of Alabama at Birmingham, wrote in their editorial. “IgM antibodies are too large to cross the placenta and so detection in a newborn reasonably could be assumed to reflect fetal production following in utero infection. However, most congenital infections are not diagnosed based on IgM detection because IgM assays can be prone to false-positive and false-negative results, along with cross-reactivity and testing challenges.”
None of the three infants had a positive reverse transcriptase–polymerase chain reaction (RT-PCR) test result, “so there is not virologic evidence for congenital infection in these cases to support the serologic suggestion of in utero transmission,” the editorialists noted.
Examining the possibility of vertical transmission
A prior case series of nine pregnant women found no transmission of the virus from mother to child, but the question of in utero transmission is not settled, said Lan Dong, MD, of the department of obstetrics and gynecology at Renmin Hospital of Wuhan University in China and colleagues. In their research letter, the investigators described a newborn with elevated IgM antibodies to novel coronavirus 2019 born to a mother with COVID-19. The infant was delivered by cesarean section February 22, 2020, at Renmin Hospital in a negative-pressure isolation room.
“The mother wore an N95 mask and did not hold the infant,” the researchers said. “The neonate had no symptoms and was immediately quarantined in the neonatal intensive care unit. At 2 hours of age, the SARS-CoV-2 IgG level was 140.32 AU/mL and the IgM level was 45.83 AU/mL.” Although the infant may have been infected at delivery, IgM antibodies usually take days to appear, Dr. Dong and colleagues wrote. “The infant’s repeatedly negative RT-PCR test results on nasopharyngeal swabs are difficult to explain, although these tests are not always positive with infection. ... Additional examination of maternal and newborn samples should be done to confirm this preliminary observation.”
A review of infants’ serologic characteristics
Hui Zeng, MD, of the department of laboratory medicine at Zhongnan Hospital of Wuhan University in China and colleagues retrospectively reviewed clinical records and laboratory results for six pregnant women with COVID-19, according to a study in JAMA. The women had mild clinical manifestations and were admitted to Zhongnan Hospital between February 16 and March 6. “All had cesarean deliveries in their third trimester in negative pressure isolation rooms,” the investigators said. “All mothers wore masks, and all medical staff wore protective suits and double masks. The infants were isolated from their mothers immediately after delivery.”
Two of the infants had elevated IgG and IgM concentrations. IgM “is not usually transferred from mother to fetus because of its larger macromolecular structure. ... Whether the placentas of women in this study were damaged and abnormal is unknown,” Dr. Zeng and colleagues said. “Alternatively, IgM could have been produced by the infant if the virus crossed the placenta.”
“Although these 2 studies deserve careful evaluation, more definitive evidence is needed” before physicians can “counsel pregnant women that their fetuses are at risk from congenital infection with SARS-CoV-2,” Dr. Kimberlin and Dr. Stagno concluded.
Dr. Dong and associates had no conflicts of interest. Their work was supported by the National Key Research and Development Project and others. Dr. Zeng and colleagues had no relevant financial disclosures. Their study was supported by grants from the National Natural Science Foundation of China and Zhongnan Hospital. Dr. Kimberlin and Dr. Stagno had no conflicts of interest.
SOURCE: Dong L et al. JAMA. 2020 Mar 26. doi: 10.1001/jama.2020.4621; Zeng H et al. JAMA. 2020 Mar 26. doi: 10.1001/jama.2020.4861.
FROM JAMA
Doctors sound off about future of medical meetings
As most 2020 medical conferences have, one by one, been canceled or rescheduled as virtual meetings in the time of a pandemic, some physicians and other healthcare professionals are wondering if this is the year that will change the scene forever.
Amid the choruses of resignation (“Unfortunately, it’s the right thing to do.”) and optimism (“See you next year!”), there have been plenty of voices describing another broad sentiment – that all was not well with medical meetings even before the coronavirus.
One dominant criticism is that there are too many meetings.
Indeed, there are many, many meetings. During 2005–2015, there were 30,000-plus medical meetings in the United States, according to a report from the Healthcare Convention and Exhibitors Association.
Most of those are of little value, tweeted Dhruv Khullar, MD, an internist at Weill Cornell Medicine, New York City (@DhruvKhullar): “One possible consequence of cancelling so many meetings due to #COVID19 is that we realize we probably don’t need most of them.”
The tweet was liked 1.9K times, which is high for a medical post. Comments were mostly in agreement, with some skepticism.
Michaela West, MD, PhD, a surgeon at North Memorial Health, Minneapolis, Minnesota, responded (@MichaelaWst): “Agree. COVID-19 may forever change our perspective regarding medical professional meetings.”
Nwando Olayiwola, MD, chair of family medicine, Ohio State University, Columbus, strongly agreed (@DrNwando): “This is the tweet I wish I tweeted.”
However, Kelly Swords, MD, MPH, urologist, University of California, San Diego, in a dissenting opinion, stated the obvious (@k_dagger): “Except there is no substitute for human interaction.”
Worth the Effort?
The cancellation of medical meetings has given those who regularly attend an opportunity to reassess their value and to question the worth of the effort involved in attending in person.
David Steensma, MD, hematologist-oncologist, Harvard Medical School, Boston, (@DavidSteensma) tweeted that he would like to scale back: “The present crisis is an opportunity to reassess what is actually necessary and rebalance [in terms of meetings].”
Travel to meetings is often unpleasant, said others.
Chris Palatucci, life sciences executive recruiter, Coulter Partners, Boston, tweeted (@LifeSciRcruitr): “I will die a happy man if I never get on another plane. Glorified bus travel.” He also believes that once the coronavirus crisis is over, its “silver lining” will be the realization that “40% of all meetings are unnecessary.”
Many professionals have welcomed the announcements that major conferences have been canceled and will be conducted virtually.
The latest change is from the American Society of Clinical Oncology (ASCO), whose annual meeting was to be held in Chicago at the end of May but will now be held online.
Virtual ASCO will be more manageable – and comfy, said Fumiko Ladd Chino, MD, radiation oncologist, Memorial Sloan Kettering Cancer Center, New York City.
She (@fumikochino) explained why in a recent tweet: “1) I will be finally able to see ALL OF THE PRESENTATIONS I wanted to see instead of wandering around feeling overwhelmed. 2) I will be able to FOCUS on the presentations and not searching for a power outlet. 3) PAJAMAS.”
Virtual meetings already beat real meetings, added Adriana Scheliga, MD, hematologist-oncologist, Brazilian National Cancer Institute (@linfopedia): “I’ve been saying this for a while. For me the best ASCO Meetings, for example, are the “virtual meetings!”
However, meetings in place are also very much about professional community and mutual support, reminds Susan E. Sedory, MA, executive director, Society of Interventional Radiology, which canceled its meeting March 6 in a multifaceted process described by Medscape Medical News.
Is This the Time to Evaluate Meetings?
Coming up soon is the first major conference to go virtual after being canceled – the American College of Cardiology (ACC), which has been one of the top 20 largest meetings in the United States by attendance.
This meeting, which was to have taken place in Chicago on March 28–30, will now occur online on those days. The ACC says it will stream all “live” sessions on demand and provide access to additional videos, abstracts, and slides for at least 90 days after the meeting. And it will be free to anyone with an Internet connection.
Medical meetings in distant locales may bounce back, as they have grown into a very big business. ASCO is illustrative.
The group’s first scientific annual meeting was held in 1965 in Philadelphia, with about 70 members and invited guests in attendance. Fast forward 50-plus years to 2019: there were 42,500 attendees, a 4.4% increase from 2018. Notably, the top countries in attendance in 2019 were the United States and China.
Not everyone is happy that canceled meetings are being held online in the middle of a pandemic.
“In a COVID-19 world, the brain cannot focus on nonviral topics,” said commentator John Mandrola, MD, Baptist Health, Louisville, Kentucky, in his regular column for Medscape Cardiology/theheart.org.
The virtual ACC meeting should be canceled or delayed – to mirror what is happening in the world, he argues. “In hospitals, we have postponed the elective to make room for the coming surge. Shouldn’t ACC do the same? After the crisis passes, we can have a virtual meeting with a proper discussion of the science,” he writes.
But #MedTwitter, with its collective constructive criticism of medical meetings, is perhaps proof that the brain can function – and arrive at clarity – when under pandemic duress.
“Am I the only one experiencing a certain relief at the cancellation of multiple trips and meetings, and vowing to let this revelation affect my decision making in the future,” tweeted Steven Joffe, MD, MPH, University of Pennsylvania, Philadelphia (@Steve Joffe).
Louise Perkins King, MD, a bioethicist at Harvard Medical School, responded to Joffe. Hoping not to “belittle” the suffering from the COVID-19 pandemic, she (@louise_p_king) addressed her healthcare colleagues: “...there is potential for us all to learn what is essential travel and burden and what is not from this. I hope it leads to lasting change.”
This article first appeared on Medscape.com.
As most 2020 medical conferences have, one by one, been canceled or rescheduled as virtual meetings in the time of a pandemic, some physicians and other healthcare professionals are wondering if this is the year that will change the scene forever.
Amid the choruses of resignation (“Unfortunately, it’s the right thing to do.”) and optimism (“See you next year!”), there have been plenty of voices describing another broad sentiment – that all was not well with medical meetings even before the coronavirus.
One dominant criticism is that there are too many meetings.
Indeed, there are many, many meetings. During 2005–2015, there were 30,000-plus medical meetings in the United States, according to a report from the Healthcare Convention and Exhibitors Association.
Most of those are of little value, tweeted Dhruv Khullar, MD, an internist at Weill Cornell Medicine, New York City (@DhruvKhullar): “One possible consequence of cancelling so many meetings due to #COVID19 is that we realize we probably don’t need most of them.”
The tweet was liked 1.9K times, which is high for a medical post. Comments were mostly in agreement, with some skepticism.
Michaela West, MD, PhD, a surgeon at North Memorial Health, Minneapolis, Minnesota, responded (@MichaelaWst): “Agree. COVID-19 may forever change our perspective regarding medical professional meetings.”
Nwando Olayiwola, MD, chair of family medicine, Ohio State University, Columbus, strongly agreed (@DrNwando): “This is the tweet I wish I tweeted.”
However, Kelly Swords, MD, MPH, urologist, University of California, San Diego, in a dissenting opinion, stated the obvious (@k_dagger): “Except there is no substitute for human interaction.”
Worth the Effort?
The cancellation of medical meetings has given those who regularly attend an opportunity to reassess their value and to question the worth of the effort involved in attending in person.
David Steensma, MD, hematologist-oncologist, Harvard Medical School, Boston, (@DavidSteensma) tweeted that he would like to scale back: “The present crisis is an opportunity to reassess what is actually necessary and rebalance [in terms of meetings].”
Travel to meetings is often unpleasant, said others.
Chris Palatucci, life sciences executive recruiter, Coulter Partners, Boston, tweeted (@LifeSciRcruitr): “I will die a happy man if I never get on another plane. Glorified bus travel.” He also believes that once the coronavirus crisis is over, its “silver lining” will be the realization that “40% of all meetings are unnecessary.”
Many professionals have welcomed the announcements that major conferences have been canceled and will be conducted virtually.
The latest change is from the American Society of Clinical Oncology (ASCO), whose annual meeting was to be held in Chicago at the end of May but will now be held online.
Virtual ASCO will be more manageable – and comfy, said Fumiko Ladd Chino, MD, radiation oncologist, Memorial Sloan Kettering Cancer Center, New York City.
She (@fumikochino) explained why in a recent tweet: “1) I will be finally able to see ALL OF THE PRESENTATIONS I wanted to see instead of wandering around feeling overwhelmed. 2) I will be able to FOCUS on the presentations and not searching for a power outlet. 3) PAJAMAS.”
Virtual meetings already beat real meetings, added Adriana Scheliga, MD, hematologist-oncologist, Brazilian National Cancer Institute (@linfopedia): “I’ve been saying this for a while. For me the best ASCO Meetings, for example, are the “virtual meetings!”
However, meetings in place are also very much about professional community and mutual support, reminds Susan E. Sedory, MA, executive director, Society of Interventional Radiology, which canceled its meeting March 6 in a multifaceted process described by Medscape Medical News.
Is This the Time to Evaluate Meetings?
Coming up soon is the first major conference to go virtual after being canceled – the American College of Cardiology (ACC), which has been one of the top 20 largest meetings in the United States by attendance.
This meeting, which was to have taken place in Chicago on March 28–30, will now occur online on those days. The ACC says it will stream all “live” sessions on demand and provide access to additional videos, abstracts, and slides for at least 90 days after the meeting. And it will be free to anyone with an Internet connection.
Medical meetings in distant locales may bounce back, as they have grown into a very big business. ASCO is illustrative.
The group’s first scientific annual meeting was held in 1965 in Philadelphia, with about 70 members and invited guests in attendance. Fast forward 50-plus years to 2019: there were 42,500 attendees, a 4.4% increase from 2018. Notably, the top countries in attendance in 2019 were the United States and China.
Not everyone is happy that canceled meetings are being held online in the middle of a pandemic.
“In a COVID-19 world, the brain cannot focus on nonviral topics,” said commentator John Mandrola, MD, Baptist Health, Louisville, Kentucky, in his regular column for Medscape Cardiology/theheart.org.
The virtual ACC meeting should be canceled or delayed – to mirror what is happening in the world, he argues. “In hospitals, we have postponed the elective to make room for the coming surge. Shouldn’t ACC do the same? After the crisis passes, we can have a virtual meeting with a proper discussion of the science,” he writes.
But #MedTwitter, with its collective constructive criticism of medical meetings, is perhaps proof that the brain can function – and arrive at clarity – when under pandemic duress.
“Am I the only one experiencing a certain relief at the cancellation of multiple trips and meetings, and vowing to let this revelation affect my decision making in the future,” tweeted Steven Joffe, MD, MPH, University of Pennsylvania, Philadelphia (@Steve Joffe).
Louise Perkins King, MD, a bioethicist at Harvard Medical School, responded to Joffe. Hoping not to “belittle” the suffering from the COVID-19 pandemic, she (@louise_p_king) addressed her healthcare colleagues: “...there is potential for us all to learn what is essential travel and burden and what is not from this. I hope it leads to lasting change.”
This article first appeared on Medscape.com.
As most 2020 medical conferences have, one by one, been canceled or rescheduled as virtual meetings in the time of a pandemic, some physicians and other healthcare professionals are wondering if this is the year that will change the scene forever.
Amid the choruses of resignation (“Unfortunately, it’s the right thing to do.”) and optimism (“See you next year!”), there have been plenty of voices describing another broad sentiment – that all was not well with medical meetings even before the coronavirus.
One dominant criticism is that there are too many meetings.
Indeed, there are many, many meetings. During 2005–2015, there were 30,000-plus medical meetings in the United States, according to a report from the Healthcare Convention and Exhibitors Association.
Most of those are of little value, tweeted Dhruv Khullar, MD, an internist at Weill Cornell Medicine, New York City (@DhruvKhullar): “One possible consequence of cancelling so many meetings due to #COVID19 is that we realize we probably don’t need most of them.”
The tweet was liked 1.9K times, which is high for a medical post. Comments were mostly in agreement, with some skepticism.
Michaela West, MD, PhD, a surgeon at North Memorial Health, Minneapolis, Minnesota, responded (@MichaelaWst): “Agree. COVID-19 may forever change our perspective regarding medical professional meetings.”
Nwando Olayiwola, MD, chair of family medicine, Ohio State University, Columbus, strongly agreed (@DrNwando): “This is the tweet I wish I tweeted.”
However, Kelly Swords, MD, MPH, urologist, University of California, San Diego, in a dissenting opinion, stated the obvious (@k_dagger): “Except there is no substitute for human interaction.”
Worth the Effort?
The cancellation of medical meetings has given those who regularly attend an opportunity to reassess their value and to question the worth of the effort involved in attending in person.
David Steensma, MD, hematologist-oncologist, Harvard Medical School, Boston, (@DavidSteensma) tweeted that he would like to scale back: “The present crisis is an opportunity to reassess what is actually necessary and rebalance [in terms of meetings].”
Travel to meetings is often unpleasant, said others.
Chris Palatucci, life sciences executive recruiter, Coulter Partners, Boston, tweeted (@LifeSciRcruitr): “I will die a happy man if I never get on another plane. Glorified bus travel.” He also believes that once the coronavirus crisis is over, its “silver lining” will be the realization that “40% of all meetings are unnecessary.”
Many professionals have welcomed the announcements that major conferences have been canceled and will be conducted virtually.
The latest change is from the American Society of Clinical Oncology (ASCO), whose annual meeting was to be held in Chicago at the end of May but will now be held online.
Virtual ASCO will be more manageable – and comfy, said Fumiko Ladd Chino, MD, radiation oncologist, Memorial Sloan Kettering Cancer Center, New York City.
She (@fumikochino) explained why in a recent tweet: “1) I will be finally able to see ALL OF THE PRESENTATIONS I wanted to see instead of wandering around feeling overwhelmed. 2) I will be able to FOCUS on the presentations and not searching for a power outlet. 3) PAJAMAS.”
Virtual meetings already beat real meetings, added Adriana Scheliga, MD, hematologist-oncologist, Brazilian National Cancer Institute (@linfopedia): “I’ve been saying this for a while. For me the best ASCO Meetings, for example, are the “virtual meetings!”
However, meetings in place are also very much about professional community and mutual support, reminds Susan E. Sedory, MA, executive director, Society of Interventional Radiology, which canceled its meeting March 6 in a multifaceted process described by Medscape Medical News.
Is This the Time to Evaluate Meetings?
Coming up soon is the first major conference to go virtual after being canceled – the American College of Cardiology (ACC), which has been one of the top 20 largest meetings in the United States by attendance.
This meeting, which was to have taken place in Chicago on March 28–30, will now occur online on those days. The ACC says it will stream all “live” sessions on demand and provide access to additional videos, abstracts, and slides for at least 90 days after the meeting. And it will be free to anyone with an Internet connection.
Medical meetings in distant locales may bounce back, as they have grown into a very big business. ASCO is illustrative.
The group’s first scientific annual meeting was held in 1965 in Philadelphia, with about 70 members and invited guests in attendance. Fast forward 50-plus years to 2019: there were 42,500 attendees, a 4.4% increase from 2018. Notably, the top countries in attendance in 2019 were the United States and China.
Not everyone is happy that canceled meetings are being held online in the middle of a pandemic.
“In a COVID-19 world, the brain cannot focus on nonviral topics,” said commentator John Mandrola, MD, Baptist Health, Louisville, Kentucky, in his regular column for Medscape Cardiology/theheart.org.
The virtual ACC meeting should be canceled or delayed – to mirror what is happening in the world, he argues. “In hospitals, we have postponed the elective to make room for the coming surge. Shouldn’t ACC do the same? After the crisis passes, we can have a virtual meeting with a proper discussion of the science,” he writes.
But #MedTwitter, with its collective constructive criticism of medical meetings, is perhaps proof that the brain can function – and arrive at clarity – when under pandemic duress.
“Am I the only one experiencing a certain relief at the cancellation of multiple trips and meetings, and vowing to let this revelation affect my decision making in the future,” tweeted Steven Joffe, MD, MPH, University of Pennsylvania, Philadelphia (@Steve Joffe).
Louise Perkins King, MD, a bioethicist at Harvard Medical School, responded to Joffe. Hoping not to “belittle” the suffering from the COVID-19 pandemic, she (@louise_p_king) addressed her healthcare colleagues: “...there is potential for us all to learn what is essential travel and burden and what is not from this. I hope it leads to lasting change.”
This article first appeared on Medscape.com.
The power and promise of person-generated health data (Part II)
In Part I of our discussion we introduced the concept of person-generated health data (PGHD), defined as wellness and/or health-related data created, recorded, or gathered by individuals.
Such rich, longitudinal information is now being used in combination with traditional clinical information to predict, diagnose, and formulate treatment plans for diseases, as well as understand the safety and effectiveness of medical interventions.
Identifying a disease early
One novel example of digital technologies being used for early identification of disease was a promising 2019 study by Eli Lilly (in collaboration with Apple and Evidation Health) called the Lilly Exploratory Digital Assessment Study.
In this study, the feasibility of using PGHD for identifying physiological and behavioral signatures of cognitive impairment was examined for the purpose of seeking new methods to detect mild cognitive impairment (MCI) in a timely and cost-effective manner. The study enrolled 31 study participants with cognitive impairment and 82 without cognitive impairment. It used consumer-grade sensor technologies (the iPhone, Apple Watch, iPad, and Beddit sleep monitor) to continuously and unobtrusively collect data. Among the information the researchers collected were interaction with the phone keyboard, accelerometer data from the Apple Watch, volume of messages sent/received, and sleep cycles.1
A total of 16 terabytes of data were collected over the course of 12 weeks. Data were organized into a behaviorgram (See Figure 1) that gives a holistic picture of a day in a patient’s life. A machine learning model was used to distinguish between behaviorgrams of symptomatic versus healthy controls, identifying typing speed, circadian rhythm shifts, and reliance on helper apps, among other things, as differentiating cognitively impaired from healthy controls. These behaviorgrams may someday serve as “fingerprints” of different diseases, with specific diseases displaying predictable patterns. In the near future, digital measures like the ones investigated in this study are likely to be used to help clinicians predict and diagnose disease, as well as to better understand disease progression and treatment response.
Leading to better health outcomes
The potential of PGHD to detect diseases early and lead to better health outcomes is being investigated in the Heartline study, a collaboration between Johnson & Johnson and Apple, which is supported by Evidation.2
This study aims to enroll 150,000 adults age 65 years and over to analyze the impact of Apple Watch–based early detection of irregular heart rhythms consistent with atrial fibrillation (AFib). The researchers’ hypothesis is that jointly detecting atrial fibrillation early and providing cardiovascular health programs to new AFib patients, will lead to patients being treated by a medical provider for AFib that otherwise would not have been detected. This, in turn, would lead to these AFib patients decreasing their risks of stroke and other serious cardiovascular events, including death, the study authors speculated.
Presenting new challenges
While PGHD has the potential to help people, it also presents new challenges. It is highly sensitive and personal – it can be as identifying as DNA.3
The vast amount of data that PGHD can collect from interaction with consumer wearable devices poses serious privacy risks if done improperly. To address those risks, companies like Evidation have built in protections. Evidation has an app, Achievement, that has enlisted a connected population of more than 3.5 million members who earn rewards for performing health-related actions, as tracked by wearables devices and apps. Through the Achievement app (See Figure 2.), members are provided opportunities to join research studies. As part of these studies, data collected from sensors and apps is used by permission of the member so that it is clear how their data are contributing to specific research questions or use cases.
This is a collaborative model of data collection built upon trust and permission and is substantially different than the collection of data from electronic health records (EHRs) – which is typically aggregated, deidentified, and commercialized, often without the patients’ knowledge or consent. Stringent protections, explicit permission, and transparency are absolutely imperative until privacy frameworks for data outside of HIPAA regulation catches up and protects patients from discrimination and unintended uses of their data.
Large connected cohorts can help advance our understanding of public health. In one study run on Achievement during the 2017-2018 flu season, a survey was sent to the Achievement population every week asking about symptoms of influenza-like illness and requesting permission to access historical data from their wearable around the influenza-like illness event.4 With the data, it was possible to analyze patterns of activity, sleep, and resting heart rate change around flu events. Resting heart rate, in particular, is shown to increase during fever and at the population level. In fact, through the use of PGHD, it is possible to use the fraction of people with resting heart rate above their usual baseline as a proxy to quantify the number of infected people in a region.5 This resting heart rate–informed flu surveillance method, if refined to increased accuracy, can work in near real time. This means it may be able detect influenza outbreaks days earlier than current epidemiological methods.
Health data generated by connected populations are in the early stages of development. It is clear that it will yield novel insights into health and disease. Only time will tell if it will be able to help clinicians and patients better predict, diagnose, and formulate treatment plans for disease.
Neil Skolnik, M.D. is a professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, and associate director of the Family Medicine Residency Program at Abington Jefferson Health. Luca Foschini PhD, is co-founder & chief data scientist at Evidation Health. Bray Patrick-Lake, MFS, is a patient thought leader and director of strategic partnerships at Evidation Health.
References
1. Chen R et al. Developing measures of cognitive impairment in the real world from consumer-grade multimodal sensor streams. KDD ’19. August 4–8, 2019 Aug 4-8.
2. The Heartline Study. https://www.heartline.com.
3. Foschini L. Privacy of Wearable and Sensors Data (or, the Lack Thereof?). Data Driven Investor, Medium. 2019.
4. Bradshaw B et al. Influenza surveillance using wearable mobile health devices. Online J Public Health Inform. 2019;11(1):e249.
5. Radin JM et al. Harnessing wearable device data to improve state-level real-time surveillance of influenza-like illness in the USA: a population-based study. Lancet Digital Health. 2020. doi: 10.1016/S2589-7500(19)30222-5.
In Part I of our discussion we introduced the concept of person-generated health data (PGHD), defined as wellness and/or health-related data created, recorded, or gathered by individuals.
Such rich, longitudinal information is now being used in combination with traditional clinical information to predict, diagnose, and formulate treatment plans for diseases, as well as understand the safety and effectiveness of medical interventions.
Identifying a disease early
One novel example of digital technologies being used for early identification of disease was a promising 2019 study by Eli Lilly (in collaboration with Apple and Evidation Health) called the Lilly Exploratory Digital Assessment Study.
In this study, the feasibility of using PGHD for identifying physiological and behavioral signatures of cognitive impairment was examined for the purpose of seeking new methods to detect mild cognitive impairment (MCI) in a timely and cost-effective manner. The study enrolled 31 study participants with cognitive impairment and 82 without cognitive impairment. It used consumer-grade sensor technologies (the iPhone, Apple Watch, iPad, and Beddit sleep monitor) to continuously and unobtrusively collect data. Among the information the researchers collected were interaction with the phone keyboard, accelerometer data from the Apple Watch, volume of messages sent/received, and sleep cycles.1
A total of 16 terabytes of data were collected over the course of 12 weeks. Data were organized into a behaviorgram (See Figure 1) that gives a holistic picture of a day in a patient’s life. A machine learning model was used to distinguish between behaviorgrams of symptomatic versus healthy controls, identifying typing speed, circadian rhythm shifts, and reliance on helper apps, among other things, as differentiating cognitively impaired from healthy controls. These behaviorgrams may someday serve as “fingerprints” of different diseases, with specific diseases displaying predictable patterns. In the near future, digital measures like the ones investigated in this study are likely to be used to help clinicians predict and diagnose disease, as well as to better understand disease progression and treatment response.
Leading to better health outcomes
The potential of PGHD to detect diseases early and lead to better health outcomes is being investigated in the Heartline study, a collaboration between Johnson & Johnson and Apple, which is supported by Evidation.2
This study aims to enroll 150,000 adults age 65 years and over to analyze the impact of Apple Watch–based early detection of irregular heart rhythms consistent with atrial fibrillation (AFib). The researchers’ hypothesis is that jointly detecting atrial fibrillation early and providing cardiovascular health programs to new AFib patients, will lead to patients being treated by a medical provider for AFib that otherwise would not have been detected. This, in turn, would lead to these AFib patients decreasing their risks of stroke and other serious cardiovascular events, including death, the study authors speculated.
Presenting new challenges
While PGHD has the potential to help people, it also presents new challenges. It is highly sensitive and personal – it can be as identifying as DNA.3
The vast amount of data that PGHD can collect from interaction with consumer wearable devices poses serious privacy risks if done improperly. To address those risks, companies like Evidation have built in protections. Evidation has an app, Achievement, that has enlisted a connected population of more than 3.5 million members who earn rewards for performing health-related actions, as tracked by wearables devices and apps. Through the Achievement app (See Figure 2.), members are provided opportunities to join research studies. As part of these studies, data collected from sensors and apps is used by permission of the member so that it is clear how their data are contributing to specific research questions or use cases.
This is a collaborative model of data collection built upon trust and permission and is substantially different than the collection of data from electronic health records (EHRs) – which is typically aggregated, deidentified, and commercialized, often without the patients’ knowledge or consent. Stringent protections, explicit permission, and transparency are absolutely imperative until privacy frameworks for data outside of HIPAA regulation catches up and protects patients from discrimination and unintended uses of their data.
Large connected cohorts can help advance our understanding of public health. In one study run on Achievement during the 2017-2018 flu season, a survey was sent to the Achievement population every week asking about symptoms of influenza-like illness and requesting permission to access historical data from their wearable around the influenza-like illness event.4 With the data, it was possible to analyze patterns of activity, sleep, and resting heart rate change around flu events. Resting heart rate, in particular, is shown to increase during fever and at the population level. In fact, through the use of PGHD, it is possible to use the fraction of people with resting heart rate above their usual baseline as a proxy to quantify the number of infected people in a region.5 This resting heart rate–informed flu surveillance method, if refined to increased accuracy, can work in near real time. This means it may be able detect influenza outbreaks days earlier than current epidemiological methods.
Health data generated by connected populations are in the early stages of development. It is clear that it will yield novel insights into health and disease. Only time will tell if it will be able to help clinicians and patients better predict, diagnose, and formulate treatment plans for disease.
Neil Skolnik, M.D. is a professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, and associate director of the Family Medicine Residency Program at Abington Jefferson Health. Luca Foschini PhD, is co-founder & chief data scientist at Evidation Health. Bray Patrick-Lake, MFS, is a patient thought leader and director of strategic partnerships at Evidation Health.
References
1. Chen R et al. Developing measures of cognitive impairment in the real world from consumer-grade multimodal sensor streams. KDD ’19. August 4–8, 2019 Aug 4-8.
2. The Heartline Study. https://www.heartline.com.
3. Foschini L. Privacy of Wearable and Sensors Data (or, the Lack Thereof?). Data Driven Investor, Medium. 2019.
4. Bradshaw B et al. Influenza surveillance using wearable mobile health devices. Online J Public Health Inform. 2019;11(1):e249.
5. Radin JM et al. Harnessing wearable device data to improve state-level real-time surveillance of influenza-like illness in the USA: a population-based study. Lancet Digital Health. 2020. doi: 10.1016/S2589-7500(19)30222-5.
In Part I of our discussion we introduced the concept of person-generated health data (PGHD), defined as wellness and/or health-related data created, recorded, or gathered by individuals.
Such rich, longitudinal information is now being used in combination with traditional clinical information to predict, diagnose, and formulate treatment plans for diseases, as well as understand the safety and effectiveness of medical interventions.
Identifying a disease early
One novel example of digital technologies being used for early identification of disease was a promising 2019 study by Eli Lilly (in collaboration with Apple and Evidation Health) called the Lilly Exploratory Digital Assessment Study.
In this study, the feasibility of using PGHD for identifying physiological and behavioral signatures of cognitive impairment was examined for the purpose of seeking new methods to detect mild cognitive impairment (MCI) in a timely and cost-effective manner. The study enrolled 31 study participants with cognitive impairment and 82 without cognitive impairment. It used consumer-grade sensor technologies (the iPhone, Apple Watch, iPad, and Beddit sleep monitor) to continuously and unobtrusively collect data. Among the information the researchers collected were interaction with the phone keyboard, accelerometer data from the Apple Watch, volume of messages sent/received, and sleep cycles.1
A total of 16 terabytes of data were collected over the course of 12 weeks. Data were organized into a behaviorgram (See Figure 1) that gives a holistic picture of a day in a patient’s life. A machine learning model was used to distinguish between behaviorgrams of symptomatic versus healthy controls, identifying typing speed, circadian rhythm shifts, and reliance on helper apps, among other things, as differentiating cognitively impaired from healthy controls. These behaviorgrams may someday serve as “fingerprints” of different diseases, with specific diseases displaying predictable patterns. In the near future, digital measures like the ones investigated in this study are likely to be used to help clinicians predict and diagnose disease, as well as to better understand disease progression and treatment response.
Leading to better health outcomes
The potential of PGHD to detect diseases early and lead to better health outcomes is being investigated in the Heartline study, a collaboration between Johnson & Johnson and Apple, which is supported by Evidation.2
This study aims to enroll 150,000 adults age 65 years and over to analyze the impact of Apple Watch–based early detection of irregular heart rhythms consistent with atrial fibrillation (AFib). The researchers’ hypothesis is that jointly detecting atrial fibrillation early and providing cardiovascular health programs to new AFib patients, will lead to patients being treated by a medical provider for AFib that otherwise would not have been detected. This, in turn, would lead to these AFib patients decreasing their risks of stroke and other serious cardiovascular events, including death, the study authors speculated.
Presenting new challenges
While PGHD has the potential to help people, it also presents new challenges. It is highly sensitive and personal – it can be as identifying as DNA.3
The vast amount of data that PGHD can collect from interaction with consumer wearable devices poses serious privacy risks if done improperly. To address those risks, companies like Evidation have built in protections. Evidation has an app, Achievement, that has enlisted a connected population of more than 3.5 million members who earn rewards for performing health-related actions, as tracked by wearables devices and apps. Through the Achievement app (See Figure 2.), members are provided opportunities to join research studies. As part of these studies, data collected from sensors and apps is used by permission of the member so that it is clear how their data are contributing to specific research questions or use cases.
This is a collaborative model of data collection built upon trust and permission and is substantially different than the collection of data from electronic health records (EHRs) – which is typically aggregated, deidentified, and commercialized, often without the patients’ knowledge or consent. Stringent protections, explicit permission, and transparency are absolutely imperative until privacy frameworks for data outside of HIPAA regulation catches up and protects patients from discrimination and unintended uses of their data.
Large connected cohorts can help advance our understanding of public health. In one study run on Achievement during the 2017-2018 flu season, a survey was sent to the Achievement population every week asking about symptoms of influenza-like illness and requesting permission to access historical data from their wearable around the influenza-like illness event.4 With the data, it was possible to analyze patterns of activity, sleep, and resting heart rate change around flu events. Resting heart rate, in particular, is shown to increase during fever and at the population level. In fact, through the use of PGHD, it is possible to use the fraction of people with resting heart rate above their usual baseline as a proxy to quantify the number of infected people in a region.5 This resting heart rate–informed flu surveillance method, if refined to increased accuracy, can work in near real time. This means it may be able detect influenza outbreaks days earlier than current epidemiological methods.
Health data generated by connected populations are in the early stages of development. It is clear that it will yield novel insights into health and disease. Only time will tell if it will be able to help clinicians and patients better predict, diagnose, and formulate treatment plans for disease.
Neil Skolnik, M.D. is a professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, and associate director of the Family Medicine Residency Program at Abington Jefferson Health. Luca Foschini PhD, is co-founder & chief data scientist at Evidation Health. Bray Patrick-Lake, MFS, is a patient thought leader and director of strategic partnerships at Evidation Health.
References
1. Chen R et al. Developing measures of cognitive impairment in the real world from consumer-grade multimodal sensor streams. KDD ’19. August 4–8, 2019 Aug 4-8.
2. The Heartline Study. https://www.heartline.com.
3. Foschini L. Privacy of Wearable and Sensors Data (or, the Lack Thereof?). Data Driven Investor, Medium. 2019.
4. Bradshaw B et al. Influenza surveillance using wearable mobile health devices. Online J Public Health Inform. 2019;11(1):e249.
5. Radin JM et al. Harnessing wearable device data to improve state-level real-time surveillance of influenza-like illness in the USA: a population-based study. Lancet Digital Health. 2020. doi: 10.1016/S2589-7500(19)30222-5.
Despite strict controls, some infants born to mothers with COVID-19 appear infected
Despite implementation of strict infection control and prevention procedures in a hospital in Wuhan, China, according to Lingkong Zeng, MD, of the department of neonatology at Wuhan Children’s Hospital, and associates.
Thirty-three neonates born to mothers with COVID-19 were included in the study, published as a research letter in JAMA Pediatrics. Of this group, three neonates (9%) were confirmed to be infected with the novel coronavirus 2019 at 2 and 4 days of life through nasopharyngeal and anal swabs.
Of the three infected neonates, two were born at 40 weeks’ gestation and the third was born at 31 weeks. The two full-term infants had mild symptoms such as lethargy and fever and were negative for the virus at 6 days of life. The preterm infant had somewhat worse symptoms, but the investigators acknowledged that “the most seriously ill neonate may have been symptomatic from prematurity, asphyxia, and sepsis, rather than [the novel coronavirus 2019] infection.” They added that outcomes for all three neonates were favorable, consistent with past research.
“Because strict infection control and prevention procedures were implemented during the delivery, it is likely that the sources of [novel coronavirus 2019] in the neonates’ upper respiratory tracts or anuses were maternal in origin,” Dr. Zeng and associates surmised.
While previous studies have shown no evidence of COVID-19 transmission between mothers and neonates, and all samples, including amniotic fluid, cord blood, and breast milk, were negative for the novel coronavirus 2019, “vertical maternal-fetal transmission cannot be ruled out in the current cohort. Therefore, it is crucial to screen pregnant women and implement strict infection control measures, quarantine of infected mothers, and close monitoring of neonates at risk of COVID-19,” the investigators concluded.
The study authors reported that they had no conflicts of interest.
SOURCE: Zeng L et al. JAMA Pediatrics. 2020 Mar 26. doi: 10.1001/jamapediatrics.2020.0878.
Despite implementation of strict infection control and prevention procedures in a hospital in Wuhan, China, according to Lingkong Zeng, MD, of the department of neonatology at Wuhan Children’s Hospital, and associates.
Thirty-three neonates born to mothers with COVID-19 were included in the study, published as a research letter in JAMA Pediatrics. Of this group, three neonates (9%) were confirmed to be infected with the novel coronavirus 2019 at 2 and 4 days of life through nasopharyngeal and anal swabs.
Of the three infected neonates, two were born at 40 weeks’ gestation and the third was born at 31 weeks. The two full-term infants had mild symptoms such as lethargy and fever and were negative for the virus at 6 days of life. The preterm infant had somewhat worse symptoms, but the investigators acknowledged that “the most seriously ill neonate may have been symptomatic from prematurity, asphyxia, and sepsis, rather than [the novel coronavirus 2019] infection.” They added that outcomes for all three neonates were favorable, consistent with past research.
“Because strict infection control and prevention procedures were implemented during the delivery, it is likely that the sources of [novel coronavirus 2019] in the neonates’ upper respiratory tracts or anuses were maternal in origin,” Dr. Zeng and associates surmised.
While previous studies have shown no evidence of COVID-19 transmission between mothers and neonates, and all samples, including amniotic fluid, cord blood, and breast milk, were negative for the novel coronavirus 2019, “vertical maternal-fetal transmission cannot be ruled out in the current cohort. Therefore, it is crucial to screen pregnant women and implement strict infection control measures, quarantine of infected mothers, and close monitoring of neonates at risk of COVID-19,” the investigators concluded.
The study authors reported that they had no conflicts of interest.
SOURCE: Zeng L et al. JAMA Pediatrics. 2020 Mar 26. doi: 10.1001/jamapediatrics.2020.0878.
Despite implementation of strict infection control and prevention procedures in a hospital in Wuhan, China, according to Lingkong Zeng, MD, of the department of neonatology at Wuhan Children’s Hospital, and associates.
Thirty-three neonates born to mothers with COVID-19 were included in the study, published as a research letter in JAMA Pediatrics. Of this group, three neonates (9%) were confirmed to be infected with the novel coronavirus 2019 at 2 and 4 days of life through nasopharyngeal and anal swabs.
Of the three infected neonates, two were born at 40 weeks’ gestation and the third was born at 31 weeks. The two full-term infants had mild symptoms such as lethargy and fever and were negative for the virus at 6 days of life. The preterm infant had somewhat worse symptoms, but the investigators acknowledged that “the most seriously ill neonate may have been symptomatic from prematurity, asphyxia, and sepsis, rather than [the novel coronavirus 2019] infection.” They added that outcomes for all three neonates were favorable, consistent with past research.
“Because strict infection control and prevention procedures were implemented during the delivery, it is likely that the sources of [novel coronavirus 2019] in the neonates’ upper respiratory tracts or anuses were maternal in origin,” Dr. Zeng and associates surmised.
While previous studies have shown no evidence of COVID-19 transmission between mothers and neonates, and all samples, including amniotic fluid, cord blood, and breast milk, were negative for the novel coronavirus 2019, “vertical maternal-fetal transmission cannot be ruled out in the current cohort. Therefore, it is crucial to screen pregnant women and implement strict infection control measures, quarantine of infected mothers, and close monitoring of neonates at risk of COVID-19,” the investigators concluded.
The study authors reported that they had no conflicts of interest.
SOURCE: Zeng L et al. JAMA Pediatrics. 2020 Mar 26. doi: 10.1001/jamapediatrics.2020.0878.
FROM JAMA PEDIATRICS
Oral propranolol shown safe in PHACE
LAHAINA, HAWAII – Reassuring evidence of the safety of oral propranolol for treatment of complicated infantile hemangiomas in patients with PHACE syndrome comes from a recent multicenter study.
Oral propranolol is now well-ensconced as first-line therapy for complicated infantile hemangiomas in otherwise healthy children. However, the beta-blocker’s use in PHACE (Posterior fossa malformations, Hemangiomas, Arterial anomalies, Cardiac defects, and Eye abnormalities) syndrome has been controversial, with concerns raised by some that it might raise the risk for arterial ischemic stroke. Not so, Moise L. Levy, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“I’m not suggesting you use propranolol with reckless abandon in this population, but this stroke concern is something that should be put to bed based on this study,” advised Dr. Levy, professor of dermatology and pediatrics at Dell Medical School in Austin, Tex., and physician-in-chief at Dell Children’s Medical Center.
PHACE syndrome is characterized by large, thick, plaque-like hemangiomas greater than 5 cm in size, most commonly on the face, although they can be located elsewhere.
“There was concern that if you found severely altered cerebrovascular arterial flow and you put a kid on a beta-blocker you might be causing some harm. But what I will tell you is that in this recently published paper this was not in fact an issue,” he said.
Dr. Levy was not an investigator in the multicenter retrospective study, which included 76 patients with PHACE syndrome treated for infantile hemangioma with oral propranolol at 0.3 mg/kg per dose or more at 11 academic tertiary care pediatric dermatology clinics. Treatment started at a median age of 56 days.
There were no strokes, TIAs, cardiovascular events, or other significant problems associated with treatment. Twenty-nine children experienced mild adverse events: minor gastrointestinal or respiratory symptoms, and sleep disturbances were threefold more frequent than reported with placebo in another study. The investigators noted that the safety experience in their PHACE syndrome population compared favorably with that in 726 infants without PHACE syndrome who received oral propranolol for hemangiomas, where the incidence of serious adverse events on treatment was 0.4% (JAMA Dermatol. 2019 Dec 11. doi: 10.1001/jamadermatol.2019.3839).
‘Hemangiomas – but we were taught that they go away’
Dr. Levy gave a shout-out to the American Academy of Pediatrics for publishing interdisciplinary expert consensus-based practice guidelines for the management of infantile hemangiomas, which he praised as “quite well done” (Pediatrics. 2019 Jan;143[1]. pii: e20183475. doi: 10.1542/peds.2018-3475).
Following release of the guidelines last year, he and other pediatric vascular anomalies experts saw an uptick in referrals from general pediatricians, which has since tapered off.
“It’s probably like for all of us: We read an article, it’s fresh on the mind, then you forget about the article and what you’ve read. So we need a little reinforcement from a learning perspective. This is a great article,” he said.
The guidelines debunk as myth the classic teaching that infantile hemangiomas go away. Explicit information is provided about the high-risk anatomic sites warranting consideration for early referral, including the periocular, lumbosacral, and perineal areas, the lip, and lower face.
“The major point is early identification of those lesions requiring evaluation and intervention. Hemangiomas generally speaking are at their ultimate size by 3-5 months of age. The bottom line is if you think something needs to be done, please send that patient, or act upon that patient, sooner rather than later. I can’t tell you how many cases of hemangiomas I’ve seen when the kid is 18 months of age, 3 years of age, 5 years, with a large area of redundant skin, scarring, or something of that sort, and it would have been really nice to have seen them earlier and acted upon them then,” the pediatric dermatologist said.
The guidelines recommend intervention or referral by 1 month of age, ideally. Guidance is provided about the use of oral propranolol as first-line therapy.
“Propranolol is something that has been a real game changer for us,” he noted. “Many people continue to be worried about side effects in using this, particularly in the young childhood population, but this paper shows pretty clearly that hypotension or bradycardia is not a real concern. I never hospitalize these patients for propranolol therapy except in high-risk populations: very preemie, any history of breathing problems. We check the blood pressure and heart rate at baseline, again at 7-10 days, and at every visit. We’ve never found any significant drop in blood pressure.”
Dr. Levy reported financial relationships with half a dozen pharmaceutical companies, none relevant to his presentation.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
LAHAINA, HAWAII – Reassuring evidence of the safety of oral propranolol for treatment of complicated infantile hemangiomas in patients with PHACE syndrome comes from a recent multicenter study.
Oral propranolol is now well-ensconced as first-line therapy for complicated infantile hemangiomas in otherwise healthy children. However, the beta-blocker’s use in PHACE (Posterior fossa malformations, Hemangiomas, Arterial anomalies, Cardiac defects, and Eye abnormalities) syndrome has been controversial, with concerns raised by some that it might raise the risk for arterial ischemic stroke. Not so, Moise L. Levy, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“I’m not suggesting you use propranolol with reckless abandon in this population, but this stroke concern is something that should be put to bed based on this study,” advised Dr. Levy, professor of dermatology and pediatrics at Dell Medical School in Austin, Tex., and physician-in-chief at Dell Children’s Medical Center.
PHACE syndrome is characterized by large, thick, plaque-like hemangiomas greater than 5 cm in size, most commonly on the face, although they can be located elsewhere.
“There was concern that if you found severely altered cerebrovascular arterial flow and you put a kid on a beta-blocker you might be causing some harm. But what I will tell you is that in this recently published paper this was not in fact an issue,” he said.
Dr. Levy was not an investigator in the multicenter retrospective study, which included 76 patients with PHACE syndrome treated for infantile hemangioma with oral propranolol at 0.3 mg/kg per dose or more at 11 academic tertiary care pediatric dermatology clinics. Treatment started at a median age of 56 days.
There were no strokes, TIAs, cardiovascular events, or other significant problems associated with treatment. Twenty-nine children experienced mild adverse events: minor gastrointestinal or respiratory symptoms, and sleep disturbances were threefold more frequent than reported with placebo in another study. The investigators noted that the safety experience in their PHACE syndrome population compared favorably with that in 726 infants without PHACE syndrome who received oral propranolol for hemangiomas, where the incidence of serious adverse events on treatment was 0.4% (JAMA Dermatol. 2019 Dec 11. doi: 10.1001/jamadermatol.2019.3839).
‘Hemangiomas – but we were taught that they go away’
Dr. Levy gave a shout-out to the American Academy of Pediatrics for publishing interdisciplinary expert consensus-based practice guidelines for the management of infantile hemangiomas, which he praised as “quite well done” (Pediatrics. 2019 Jan;143[1]. pii: e20183475. doi: 10.1542/peds.2018-3475).
Following release of the guidelines last year, he and other pediatric vascular anomalies experts saw an uptick in referrals from general pediatricians, which has since tapered off.
“It’s probably like for all of us: We read an article, it’s fresh on the mind, then you forget about the article and what you’ve read. So we need a little reinforcement from a learning perspective. This is a great article,” he said.
The guidelines debunk as myth the classic teaching that infantile hemangiomas go away. Explicit information is provided about the high-risk anatomic sites warranting consideration for early referral, including the periocular, lumbosacral, and perineal areas, the lip, and lower face.
“The major point is early identification of those lesions requiring evaluation and intervention. Hemangiomas generally speaking are at their ultimate size by 3-5 months of age. The bottom line is if you think something needs to be done, please send that patient, or act upon that patient, sooner rather than later. I can’t tell you how many cases of hemangiomas I’ve seen when the kid is 18 months of age, 3 years of age, 5 years, with a large area of redundant skin, scarring, or something of that sort, and it would have been really nice to have seen them earlier and acted upon them then,” the pediatric dermatologist said.
The guidelines recommend intervention or referral by 1 month of age, ideally. Guidance is provided about the use of oral propranolol as first-line therapy.
“Propranolol is something that has been a real game changer for us,” he noted. “Many people continue to be worried about side effects in using this, particularly in the young childhood population, but this paper shows pretty clearly that hypotension or bradycardia is not a real concern. I never hospitalize these patients for propranolol therapy except in high-risk populations: very preemie, any history of breathing problems. We check the blood pressure and heart rate at baseline, again at 7-10 days, and at every visit. We’ve never found any significant drop in blood pressure.”
Dr. Levy reported financial relationships with half a dozen pharmaceutical companies, none relevant to his presentation.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
LAHAINA, HAWAII – Reassuring evidence of the safety of oral propranolol for treatment of complicated infantile hemangiomas in patients with PHACE syndrome comes from a recent multicenter study.
Oral propranolol is now well-ensconced as first-line therapy for complicated infantile hemangiomas in otherwise healthy children. However, the beta-blocker’s use in PHACE (Posterior fossa malformations, Hemangiomas, Arterial anomalies, Cardiac defects, and Eye abnormalities) syndrome has been controversial, with concerns raised by some that it might raise the risk for arterial ischemic stroke. Not so, Moise L. Levy, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“I’m not suggesting you use propranolol with reckless abandon in this population, but this stroke concern is something that should be put to bed based on this study,” advised Dr. Levy, professor of dermatology and pediatrics at Dell Medical School in Austin, Tex., and physician-in-chief at Dell Children’s Medical Center.
PHACE syndrome is characterized by large, thick, plaque-like hemangiomas greater than 5 cm in size, most commonly on the face, although they can be located elsewhere.
“There was concern that if you found severely altered cerebrovascular arterial flow and you put a kid on a beta-blocker you might be causing some harm. But what I will tell you is that in this recently published paper this was not in fact an issue,” he said.
Dr. Levy was not an investigator in the multicenter retrospective study, which included 76 patients with PHACE syndrome treated for infantile hemangioma with oral propranolol at 0.3 mg/kg per dose or more at 11 academic tertiary care pediatric dermatology clinics. Treatment started at a median age of 56 days.
There were no strokes, TIAs, cardiovascular events, or other significant problems associated with treatment. Twenty-nine children experienced mild adverse events: minor gastrointestinal or respiratory symptoms, and sleep disturbances were threefold more frequent than reported with placebo in another study. The investigators noted that the safety experience in their PHACE syndrome population compared favorably with that in 726 infants without PHACE syndrome who received oral propranolol for hemangiomas, where the incidence of serious adverse events on treatment was 0.4% (JAMA Dermatol. 2019 Dec 11. doi: 10.1001/jamadermatol.2019.3839).
‘Hemangiomas – but we were taught that they go away’
Dr. Levy gave a shout-out to the American Academy of Pediatrics for publishing interdisciplinary expert consensus-based practice guidelines for the management of infantile hemangiomas, which he praised as “quite well done” (Pediatrics. 2019 Jan;143[1]. pii: e20183475. doi: 10.1542/peds.2018-3475).
Following release of the guidelines last year, he and other pediatric vascular anomalies experts saw an uptick in referrals from general pediatricians, which has since tapered off.
“It’s probably like for all of us: We read an article, it’s fresh on the mind, then you forget about the article and what you’ve read. So we need a little reinforcement from a learning perspective. This is a great article,” he said.
The guidelines debunk as myth the classic teaching that infantile hemangiomas go away. Explicit information is provided about the high-risk anatomic sites warranting consideration for early referral, including the periocular, lumbosacral, and perineal areas, the lip, and lower face.
“The major point is early identification of those lesions requiring evaluation and intervention. Hemangiomas generally speaking are at their ultimate size by 3-5 months of age. The bottom line is if you think something needs to be done, please send that patient, or act upon that patient, sooner rather than later. I can’t tell you how many cases of hemangiomas I’ve seen when the kid is 18 months of age, 3 years of age, 5 years, with a large area of redundant skin, scarring, or something of that sort, and it would have been really nice to have seen them earlier and acted upon them then,” the pediatric dermatologist said.
The guidelines recommend intervention or referral by 1 month of age, ideally. Guidance is provided about the use of oral propranolol as first-line therapy.
“Propranolol is something that has been a real game changer for us,” he noted. “Many people continue to be worried about side effects in using this, particularly in the young childhood population, but this paper shows pretty clearly that hypotension or bradycardia is not a real concern. I never hospitalize these patients for propranolol therapy except in high-risk populations: very preemie, any history of breathing problems. We check the blood pressure and heart rate at baseline, again at 7-10 days, and at every visit. We’ve never found any significant drop in blood pressure.”
Dr. Levy reported financial relationships with half a dozen pharmaceutical companies, none relevant to his presentation.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
REPORTING FROM SDEF HAWAII DERMATOLOGY SEMINAR
Wuhan data link COVID-19 with myocardial damage
The first data on myocardial injury linked with COVID-19 disease during the start of the pandemic in Wuhan, China serves as a “wake up call” for clinicians and the general public on what the United States and other Western countries can expect as the SARS-CoV-2 virus spreads and case numbers mount: a potentially “daunting” toll of deaths as an infection with a tendency to be most severe in patients with underlying cardiovascular disease hits populations that include large numbers of such patients.
“A consistent picture emerges” from two reports on a total of 603 COVID-19 patients treated at two academic hospitals in Wuhan, which described “remarkably similar characteristics of patients who develop myocardial injury” associated with their infection. “Patients who develop myocardial injury with COVID-19 have clinical evidence of higher acuity, with a higher incidence of acute respiratory distress syndrome and more frequent need for assisted ventilation than those without myocardial injury, and the patients who are more prone to have myocardial injury are “older patients with preexisting cardiovascular complications and diabetes,” Robert O. Bonow, MD, and coauthors wrote in an editorial published online (JAMA Cardiol. 2020 Mar 27. doi: 10.1001/jamacardio.2020.1105).
These new findings have special relevance to the United States and other Western countries because of their substantial numbers of elderly patients with cardiovascular diseases, said Dr. Bonow, professor of medicine at Northwestern University, Chicago, and coauthors.
One of the two reports cited in the editorial reviewed 416 patients hospitalized at Renmin Hospital in Wuhan during the period of Jan. 20 to Feb. 10, 2020, with confirmed COVID-19 disease, and found that 20% of the cohort had evidence of cardiac injury, defined as blood levels of the high-sensitivity troponin I cardiac biomarker above the 99th-percentile upper reference limit, regardless of new abnormalities in electrocardiography and echocardiography.
The analysis also showed that patients with myocardial injury had a significantly higher in-hospital mortality rate, 51%, compared with a 5% mortality rate among patients without myocardial injury, and among patients with myocardial injury those with elevated high-sensitivity troponin I had an even higher mortality rate (JAMA Cardiol. 2020 Mar 25. doi: 10.1001/jamacardio.2020.0950).
A second review of 187 confirmed COVID-19 cases at Seventh Hospital in Wuhan during the period of Jan. 23 to Feb. 23, 2020, showed similar findings, with a 28% prevalence of myocardial injury at admission based on an elevated level of plasma troponin T (TnT), and 35% had cardiovascular disease (CVD) including hypertension, coronary heart disease, and cardiomyopathy. Elevated TnT levels and CVD at entry each linked with substantially increased mortality. The incidence of death among patients with elevated TnT and no underlying CVD was 38% compared with 8% among patients without elevated TnT or underlying CVD. Among patients admitted with underlying CVD those who also had an elevated TnT had a 69% death rate during hospitalization compared with a 13% rate in those without TnT elevation (JAMA Cardiol. 2020 Mar 27. doi: 10.1001/jamacardio.2020.1017).
Dr. Bonow and coauthors noted that patients with chronic coronary artery disease have a heightened risk for developing acute coronary syndrome during acute infection, potentially resulting from a severe increase in myocardial demand during infection, or severe systemic inflammatory stress that could result in atherosclerotic plaque instability and rupture as well as vascular and myocardial inflammation.
In addition, patients with heart failure are prone to hemodynamic instability during severe infection. “Thus it is anticipated that patients with underlying cardiovascular diseases, which are more prevalent in older adults, would be susceptible to higher risks of adverse outcomes and death during the severe and aggressive inflammatory responses to COVID-19 than individuals who are younger and healthier,” they wrote.
They also cited the potential for acute or fulminant myocarditis as well as new-onset heart failure caused by the SARS-CoV-2 virus that causes COVID-19 disease based on experience with the related Middle East respiratory syndrome coronavirus. Another concerning observation is that the SARS-CoV-2 virus binds to the angiotensin-converting enzyme 2 protein on cell surfaces as its main entry receptor, “raising the possibility of direct viral infection of vascular endothelium and myocardium,” a process that itself could produce myocardial injury and myocarditis.
These new findings from COVID-19 patients in Wuhan represent early data from what has become a global pandemic, and raise questions about generalizability, but for the time being a key message from these early cases is that prevention of SARS-CoV-2 infection is paramount. “Until we know more, the populations described in these primary data reports should be most observant of strict hand hygiene, social distancing, and, where available, COVID-19 testing,” the authors said.
Dr. Bonow and coauthors had no disclosures.
The first data on myocardial injury linked with COVID-19 disease during the start of the pandemic in Wuhan, China serves as a “wake up call” for clinicians and the general public on what the United States and other Western countries can expect as the SARS-CoV-2 virus spreads and case numbers mount: a potentially “daunting” toll of deaths as an infection with a tendency to be most severe in patients with underlying cardiovascular disease hits populations that include large numbers of such patients.
“A consistent picture emerges” from two reports on a total of 603 COVID-19 patients treated at two academic hospitals in Wuhan, which described “remarkably similar characteristics of patients who develop myocardial injury” associated with their infection. “Patients who develop myocardial injury with COVID-19 have clinical evidence of higher acuity, with a higher incidence of acute respiratory distress syndrome and more frequent need for assisted ventilation than those without myocardial injury, and the patients who are more prone to have myocardial injury are “older patients with preexisting cardiovascular complications and diabetes,” Robert O. Bonow, MD, and coauthors wrote in an editorial published online (JAMA Cardiol. 2020 Mar 27. doi: 10.1001/jamacardio.2020.1105).
These new findings have special relevance to the United States and other Western countries because of their substantial numbers of elderly patients with cardiovascular diseases, said Dr. Bonow, professor of medicine at Northwestern University, Chicago, and coauthors.
One of the two reports cited in the editorial reviewed 416 patients hospitalized at Renmin Hospital in Wuhan during the period of Jan. 20 to Feb. 10, 2020, with confirmed COVID-19 disease, and found that 20% of the cohort had evidence of cardiac injury, defined as blood levels of the high-sensitivity troponin I cardiac biomarker above the 99th-percentile upper reference limit, regardless of new abnormalities in electrocardiography and echocardiography.
The analysis also showed that patients with myocardial injury had a significantly higher in-hospital mortality rate, 51%, compared with a 5% mortality rate among patients without myocardial injury, and among patients with myocardial injury those with elevated high-sensitivity troponin I had an even higher mortality rate (JAMA Cardiol. 2020 Mar 25. doi: 10.1001/jamacardio.2020.0950).
A second review of 187 confirmed COVID-19 cases at Seventh Hospital in Wuhan during the period of Jan. 23 to Feb. 23, 2020, showed similar findings, with a 28% prevalence of myocardial injury at admission based on an elevated level of plasma troponin T (TnT), and 35% had cardiovascular disease (CVD) including hypertension, coronary heart disease, and cardiomyopathy. Elevated TnT levels and CVD at entry each linked with substantially increased mortality. The incidence of death among patients with elevated TnT and no underlying CVD was 38% compared with 8% among patients without elevated TnT or underlying CVD. Among patients admitted with underlying CVD those who also had an elevated TnT had a 69% death rate during hospitalization compared with a 13% rate in those without TnT elevation (JAMA Cardiol. 2020 Mar 27. doi: 10.1001/jamacardio.2020.1017).
Dr. Bonow and coauthors noted that patients with chronic coronary artery disease have a heightened risk for developing acute coronary syndrome during acute infection, potentially resulting from a severe increase in myocardial demand during infection, or severe systemic inflammatory stress that could result in atherosclerotic plaque instability and rupture as well as vascular and myocardial inflammation.
In addition, patients with heart failure are prone to hemodynamic instability during severe infection. “Thus it is anticipated that patients with underlying cardiovascular diseases, which are more prevalent in older adults, would be susceptible to higher risks of adverse outcomes and death during the severe and aggressive inflammatory responses to COVID-19 than individuals who are younger and healthier,” they wrote.
They also cited the potential for acute or fulminant myocarditis as well as new-onset heart failure caused by the SARS-CoV-2 virus that causes COVID-19 disease based on experience with the related Middle East respiratory syndrome coronavirus. Another concerning observation is that the SARS-CoV-2 virus binds to the angiotensin-converting enzyme 2 protein on cell surfaces as its main entry receptor, “raising the possibility of direct viral infection of vascular endothelium and myocardium,” a process that itself could produce myocardial injury and myocarditis.
These new findings from COVID-19 patients in Wuhan represent early data from what has become a global pandemic, and raise questions about generalizability, but for the time being a key message from these early cases is that prevention of SARS-CoV-2 infection is paramount. “Until we know more, the populations described in these primary data reports should be most observant of strict hand hygiene, social distancing, and, where available, COVID-19 testing,” the authors said.
Dr. Bonow and coauthors had no disclosures.
The first data on myocardial injury linked with COVID-19 disease during the start of the pandemic in Wuhan, China serves as a “wake up call” for clinicians and the general public on what the United States and other Western countries can expect as the SARS-CoV-2 virus spreads and case numbers mount: a potentially “daunting” toll of deaths as an infection with a tendency to be most severe in patients with underlying cardiovascular disease hits populations that include large numbers of such patients.
“A consistent picture emerges” from two reports on a total of 603 COVID-19 patients treated at two academic hospitals in Wuhan, which described “remarkably similar characteristics of patients who develop myocardial injury” associated with their infection. “Patients who develop myocardial injury with COVID-19 have clinical evidence of higher acuity, with a higher incidence of acute respiratory distress syndrome and more frequent need for assisted ventilation than those without myocardial injury, and the patients who are more prone to have myocardial injury are “older patients with preexisting cardiovascular complications and diabetes,” Robert O. Bonow, MD, and coauthors wrote in an editorial published online (JAMA Cardiol. 2020 Mar 27. doi: 10.1001/jamacardio.2020.1105).
These new findings have special relevance to the United States and other Western countries because of their substantial numbers of elderly patients with cardiovascular diseases, said Dr. Bonow, professor of medicine at Northwestern University, Chicago, and coauthors.
One of the two reports cited in the editorial reviewed 416 patients hospitalized at Renmin Hospital in Wuhan during the period of Jan. 20 to Feb. 10, 2020, with confirmed COVID-19 disease, and found that 20% of the cohort had evidence of cardiac injury, defined as blood levels of the high-sensitivity troponin I cardiac biomarker above the 99th-percentile upper reference limit, regardless of new abnormalities in electrocardiography and echocardiography.
The analysis also showed that patients with myocardial injury had a significantly higher in-hospital mortality rate, 51%, compared with a 5% mortality rate among patients without myocardial injury, and among patients with myocardial injury those with elevated high-sensitivity troponin I had an even higher mortality rate (JAMA Cardiol. 2020 Mar 25. doi: 10.1001/jamacardio.2020.0950).
A second review of 187 confirmed COVID-19 cases at Seventh Hospital in Wuhan during the period of Jan. 23 to Feb. 23, 2020, showed similar findings, with a 28% prevalence of myocardial injury at admission based on an elevated level of plasma troponin T (TnT), and 35% had cardiovascular disease (CVD) including hypertension, coronary heart disease, and cardiomyopathy. Elevated TnT levels and CVD at entry each linked with substantially increased mortality. The incidence of death among patients with elevated TnT and no underlying CVD was 38% compared with 8% among patients without elevated TnT or underlying CVD. Among patients admitted with underlying CVD those who also had an elevated TnT had a 69% death rate during hospitalization compared with a 13% rate in those without TnT elevation (JAMA Cardiol. 2020 Mar 27. doi: 10.1001/jamacardio.2020.1017).
Dr. Bonow and coauthors noted that patients with chronic coronary artery disease have a heightened risk for developing acute coronary syndrome during acute infection, potentially resulting from a severe increase in myocardial demand during infection, or severe systemic inflammatory stress that could result in atherosclerotic plaque instability and rupture as well as vascular and myocardial inflammation.
In addition, patients with heart failure are prone to hemodynamic instability during severe infection. “Thus it is anticipated that patients with underlying cardiovascular diseases, which are more prevalent in older adults, would be susceptible to higher risks of adverse outcomes and death during the severe and aggressive inflammatory responses to COVID-19 than individuals who are younger and healthier,” they wrote.
They also cited the potential for acute or fulminant myocarditis as well as new-onset heart failure caused by the SARS-CoV-2 virus that causes COVID-19 disease based on experience with the related Middle East respiratory syndrome coronavirus. Another concerning observation is that the SARS-CoV-2 virus binds to the angiotensin-converting enzyme 2 protein on cell surfaces as its main entry receptor, “raising the possibility of direct viral infection of vascular endothelium and myocardium,” a process that itself could produce myocardial injury and myocarditis.
These new findings from COVID-19 patients in Wuhan represent early data from what has become a global pandemic, and raise questions about generalizability, but for the time being a key message from these early cases is that prevention of SARS-CoV-2 infection is paramount. “Until we know more, the populations described in these primary data reports should be most observant of strict hand hygiene, social distancing, and, where available, COVID-19 testing,” the authors said.
Dr. Bonow and coauthors had no disclosures.
FROM JAMA CARDIOLOGY
Rheumatologists seek to reassure amid hydroxychloroquine shortage
Physicians and pharmacists are reporting shortages of hydroxychloroquine and chloroquine following President Trump’s promotion of the medications as potential COVID-19 treatments, leaving patients with rheumatic diseases wondering how it will impact their access.
The American Medical Association, the American Pharmacists Association, and the American Society of Health-System Pharmacists, issued a joint statement that strongly opposed prophylactic prescribing of these medications for COVID-19 or stockpiling them in anticipation of use for COVID-19. The concerns over shortages have also prompted the American College of Rheumatology, American Academy of Dermatology, Arthritis Foundation, and Lupus Foundation of America to send a joint statement to the Trump administration and the nation’s governors highlighting critical hydroxychloroquine access issues and asking policymakers to work together with health care providers and patient communities to ensure continued availability of these drugs.
Now
In a Q and A interview, NYU Langone Health rheumatology division director and Lupus Center director Jill P. Buyon, MD, and associate professor of rheumatology, Peter M. Izmirly, MD, noted that, while shortages have been reported across the United States because of large increases in off-label prescribing, many of the drugs’ manufacturers have committed to donating millions of doses and/or stepping up production to meet demand.
Later in this article, Michael H. Pillinger, MD, a rheumatologist and professor of medicine, biochemistry, and molecular pharmacology at NYU Langone Health, New York, answered questions about a new multicenter study called COLCORONA getting underway to test the anti-inflammatory drug colchicine. The answers in this Q&A have been edited for length and clarity.
Questions about hydroxychloroquine shortage
Q: What is the current situation with hydroxychloroquine in your practice?
A: We have been getting calls from our patients asking about getting refills for hydroxychloroquine. Our group has been calling local pharmacies asking about the availability of hydroxychloroquine, and we are compiling a list of pharmacies in New York with current availabilities to share with patients. We are somewhat limited by our electronic health record system, Epic, which can only send a prescription to one pharmacy, so that has placed some limitations on knowing where it is available. Some pharmacies have not had hydroxychloroquine available, while others have. We have also been encouraging patients to check online and look for mail-order possibilities for 90-day supplies.
Nearly all prescriptions are for generic hydroxychloroquine. Branded hydroxychloroquine (Plaquenil) is much more expensive, and we can run into obstacles with getting it approved by insurers, too.
Q: What are you telling patients who seek to refill their prescription or call with concerns? Is it feasible for patients to stop hydroxychloroquine or cut their dosage if necessary?
A: If someone’s been on hydroxychloroquine and has benefited from its use there’s no reason to come off it at this time, and given the possibility that it may have an effect on COVID-19, that is all the better. But we want to reassure patients that they can get the drug and that it is not difficult to manufacture.
Given the significantly higher risk of disease flare that was first described in lupus patients who discontinued hydroxychloroquine in the Canadian Hydroxychloroquine Study Group’s 1991 randomized, controlled trial, it is not advisable for patients to stop the drug.
Some patients do split their dosage day-to-day if they are taking less than 400 mg daily, such that someone taking 300 mg daily may take two 200-mg tablets one day and just one 200-mg tablet the next day, and so on. To avoid eye toxicity that can occur after years of taking the drug, hydroxychloroquine is generally prescribed based on weight at 5 mg/kg.
The drug also stays in the body for quite a while [often up to 3 months and even longer], so that is helpful for patients to know.
Given the current situation and the possibility of its effectiveness against COVID-19, it is ironic that we are actually trying to recruit older lupus patients who have had long-term stable disease while on hydroxychloroquine to a trial of stopping the drug to reduce the risk of developing the side effect of retinopathy. We want to see if patients can safely withdraw hydroxychloroquine without flaring, so we hope to not run into enrollment difficulties based on the current situation with COVID-19.
Q: How do you view the balance between having enough hydroxychloroquine for patients with lupus or other rheumatic diseases and its use in COVID-19 patients?
A: We want to reassure patients that hydroxychloroquine will be available, and there is no reason to hoard the drug or to worry excessively about being unable to obtain it. Efforts to increase production by Mylan, Teva, Sanofi, Novartis, and other manufacturers of hydroxychloroquine should really help out.
Q: Are there pharmacy restrictions on prescription amounts?
A: This is not universal at this time, but some institutions are cutting back and offering only 1-month supplies.
Colchicine COVID-19 trial underway
Dr. Pillinger, of NYU Langone Health, explored the COLCORONA study of colchicine as a treatment for people infected with COVID-19 and the worry that shortage concerns may arise for it, too.
Q: What is the general availability of colchicine and its susceptibility to shortage?
A: There are two major manufacturers of colchicine in the United States, Takeda and Hikma, who together manufacture the majority of the drug.
The greatest use of colchicine in the United States is for gout, which affects approximately 4 million Americans, but the drug is not used chronically, so a much smaller number of patients are using colchicine at any one time. Colchicine is also used for other inflammatory conditions, primarily calcium pyrophosphate crystal disease and familial Mediterranean fever (FMF is rare in the United States). Cardiologists also regularly prescribe colchicine in pericarditis for short-term use. Physicians may use it off label for other purposes, too.
Overall, the number of patients using colchicine is much larger than that for the use of hydroxychloroquine, for example, suggesting that the immediate risk of shortage could be lower. However, if individuals started using it off label, or prescribing inappropriately for the COVID-19 indication, the supply would rapidly run short.
Q: What other points are there to consider regarding the use of colchicine to treat COVID-19?
A: There is no evidence – zero – that colchicine has any benefit for COVID-19, not even case reports. There is some rationale that it might be beneficial, but that is exactly why the COLCORONA trial would be logical to try.
The COLCORONA trial is exactly the kind of trial that would be needed for assessing colchicine, and it is big enough and happening quickly enough to get an answer. But if people start to use colchicine off label, we may never know the truth.
While colchicine can be used safely in most people, it can be very problematic and requires an experienced doctor’s supervision. Overdoses can be fatal, and colchicine interacts with many drugs, all of which require dose adjustment and some of which must be stopped in order to use colchicine – it isn’t candy. Some of the other drugs being looked at for COVID-19 in fact may interact with colchicine.
Colchicine must also be dose adjusted for kidney disease, and, in some of the COVID-19 patients, kidney function changes rapidly. So again, its use would require expert supervision even if there were evidence for its utility.
The side effects of colchicine, if mis-dosed, can be very unpleasant, including nausea, vomiting, and diarrhea. Even at the apparent right dose, some people will get these side effects, so colchicine has to be something that works to make the risk/benefit ratio worth it.
Some preparations of colchicine are made combined with probenecid, a gout drug. This is even more problematic because probenecid can raise the level of drugs excreted by the kidney and could affect other treatments.
So in sum, what may be a good idea in theory can turn out to be a disastrous idea in practice, and here we have nothing but theory. This is not an agent to use randomly; the studies will be rushed out quickly and hopefully will give us the knowledge to know what to do.
Dr. Izmirly and Dr. Buyon said they have research grants with the National Institutes of Health to study hydroxychloroquine in patients with lupus and in anti–SSA/Ro-positive pregnant women with a previous child with congenital heart block. Dr. Pillinger reports that he has an investigator-initiated grant from Hikma to study colchicine in osteoarthritis.
This article was reformatted on 3/30/2020 for clarity.
Physicians and pharmacists are reporting shortages of hydroxychloroquine and chloroquine following President Trump’s promotion of the medications as potential COVID-19 treatments, leaving patients with rheumatic diseases wondering how it will impact their access.
The American Medical Association, the American Pharmacists Association, and the American Society of Health-System Pharmacists, issued a joint statement that strongly opposed prophylactic prescribing of these medications for COVID-19 or stockpiling them in anticipation of use for COVID-19. The concerns over shortages have also prompted the American College of Rheumatology, American Academy of Dermatology, Arthritis Foundation, and Lupus Foundation of America to send a joint statement to the Trump administration and the nation’s governors highlighting critical hydroxychloroquine access issues and asking policymakers to work together with health care providers and patient communities to ensure continued availability of these drugs.
Now
In a Q and A interview, NYU Langone Health rheumatology division director and Lupus Center director Jill P. Buyon, MD, and associate professor of rheumatology, Peter M. Izmirly, MD, noted that, while shortages have been reported across the United States because of large increases in off-label prescribing, many of the drugs’ manufacturers have committed to donating millions of doses and/or stepping up production to meet demand.
Later in this article, Michael H. Pillinger, MD, a rheumatologist and professor of medicine, biochemistry, and molecular pharmacology at NYU Langone Health, New York, answered questions about a new multicenter study called COLCORONA getting underway to test the anti-inflammatory drug colchicine. The answers in this Q&A have been edited for length and clarity.
Questions about hydroxychloroquine shortage
Q: What is the current situation with hydroxychloroquine in your practice?
A: We have been getting calls from our patients asking about getting refills for hydroxychloroquine. Our group has been calling local pharmacies asking about the availability of hydroxychloroquine, and we are compiling a list of pharmacies in New York with current availabilities to share with patients. We are somewhat limited by our electronic health record system, Epic, which can only send a prescription to one pharmacy, so that has placed some limitations on knowing where it is available. Some pharmacies have not had hydroxychloroquine available, while others have. We have also been encouraging patients to check online and look for mail-order possibilities for 90-day supplies.
Nearly all prescriptions are for generic hydroxychloroquine. Branded hydroxychloroquine (Plaquenil) is much more expensive, and we can run into obstacles with getting it approved by insurers, too.
Q: What are you telling patients who seek to refill their prescription or call with concerns? Is it feasible for patients to stop hydroxychloroquine or cut their dosage if necessary?
A: If someone’s been on hydroxychloroquine and has benefited from its use there’s no reason to come off it at this time, and given the possibility that it may have an effect on COVID-19, that is all the better. But we want to reassure patients that they can get the drug and that it is not difficult to manufacture.
Given the significantly higher risk of disease flare that was first described in lupus patients who discontinued hydroxychloroquine in the Canadian Hydroxychloroquine Study Group’s 1991 randomized, controlled trial, it is not advisable for patients to stop the drug.
Some patients do split their dosage day-to-day if they are taking less than 400 mg daily, such that someone taking 300 mg daily may take two 200-mg tablets one day and just one 200-mg tablet the next day, and so on. To avoid eye toxicity that can occur after years of taking the drug, hydroxychloroquine is generally prescribed based on weight at 5 mg/kg.
The drug also stays in the body for quite a while [often up to 3 months and even longer], so that is helpful for patients to know.
Given the current situation and the possibility of its effectiveness against COVID-19, it is ironic that we are actually trying to recruit older lupus patients who have had long-term stable disease while on hydroxychloroquine to a trial of stopping the drug to reduce the risk of developing the side effect of retinopathy. We want to see if patients can safely withdraw hydroxychloroquine without flaring, so we hope to not run into enrollment difficulties based on the current situation with COVID-19.
Q: How do you view the balance between having enough hydroxychloroquine for patients with lupus or other rheumatic diseases and its use in COVID-19 patients?
A: We want to reassure patients that hydroxychloroquine will be available, and there is no reason to hoard the drug or to worry excessively about being unable to obtain it. Efforts to increase production by Mylan, Teva, Sanofi, Novartis, and other manufacturers of hydroxychloroquine should really help out.
Q: Are there pharmacy restrictions on prescription amounts?
A: This is not universal at this time, but some institutions are cutting back and offering only 1-month supplies.
Colchicine COVID-19 trial underway
Dr. Pillinger, of NYU Langone Health, explored the COLCORONA study of colchicine as a treatment for people infected with COVID-19 and the worry that shortage concerns may arise for it, too.
Q: What is the general availability of colchicine and its susceptibility to shortage?
A: There are two major manufacturers of colchicine in the United States, Takeda and Hikma, who together manufacture the majority of the drug.
The greatest use of colchicine in the United States is for gout, which affects approximately 4 million Americans, but the drug is not used chronically, so a much smaller number of patients are using colchicine at any one time. Colchicine is also used for other inflammatory conditions, primarily calcium pyrophosphate crystal disease and familial Mediterranean fever (FMF is rare in the United States). Cardiologists also regularly prescribe colchicine in pericarditis for short-term use. Physicians may use it off label for other purposes, too.
Overall, the number of patients using colchicine is much larger than that for the use of hydroxychloroquine, for example, suggesting that the immediate risk of shortage could be lower. However, if individuals started using it off label, or prescribing inappropriately for the COVID-19 indication, the supply would rapidly run short.
Q: What other points are there to consider regarding the use of colchicine to treat COVID-19?
A: There is no evidence – zero – that colchicine has any benefit for COVID-19, not even case reports. There is some rationale that it might be beneficial, but that is exactly why the COLCORONA trial would be logical to try.
The COLCORONA trial is exactly the kind of trial that would be needed for assessing colchicine, and it is big enough and happening quickly enough to get an answer. But if people start to use colchicine off label, we may never know the truth.
While colchicine can be used safely in most people, it can be very problematic and requires an experienced doctor’s supervision. Overdoses can be fatal, and colchicine interacts with many drugs, all of which require dose adjustment and some of which must be stopped in order to use colchicine – it isn’t candy. Some of the other drugs being looked at for COVID-19 in fact may interact with colchicine.
Colchicine must also be dose adjusted for kidney disease, and, in some of the COVID-19 patients, kidney function changes rapidly. So again, its use would require expert supervision even if there were evidence for its utility.
The side effects of colchicine, if mis-dosed, can be very unpleasant, including nausea, vomiting, and diarrhea. Even at the apparent right dose, some people will get these side effects, so colchicine has to be something that works to make the risk/benefit ratio worth it.
Some preparations of colchicine are made combined with probenecid, a gout drug. This is even more problematic because probenecid can raise the level of drugs excreted by the kidney and could affect other treatments.
So in sum, what may be a good idea in theory can turn out to be a disastrous idea in practice, and here we have nothing but theory. This is not an agent to use randomly; the studies will be rushed out quickly and hopefully will give us the knowledge to know what to do.
Dr. Izmirly and Dr. Buyon said they have research grants with the National Institutes of Health to study hydroxychloroquine in patients with lupus and in anti–SSA/Ro-positive pregnant women with a previous child with congenital heart block. Dr. Pillinger reports that he has an investigator-initiated grant from Hikma to study colchicine in osteoarthritis.
This article was reformatted on 3/30/2020 for clarity.
Physicians and pharmacists are reporting shortages of hydroxychloroquine and chloroquine following President Trump’s promotion of the medications as potential COVID-19 treatments, leaving patients with rheumatic diseases wondering how it will impact their access.
The American Medical Association, the American Pharmacists Association, and the American Society of Health-System Pharmacists, issued a joint statement that strongly opposed prophylactic prescribing of these medications for COVID-19 or stockpiling them in anticipation of use for COVID-19. The concerns over shortages have also prompted the American College of Rheumatology, American Academy of Dermatology, Arthritis Foundation, and Lupus Foundation of America to send a joint statement to the Trump administration and the nation’s governors highlighting critical hydroxychloroquine access issues and asking policymakers to work together with health care providers and patient communities to ensure continued availability of these drugs.
Now
In a Q and A interview, NYU Langone Health rheumatology division director and Lupus Center director Jill P. Buyon, MD, and associate professor of rheumatology, Peter M. Izmirly, MD, noted that, while shortages have been reported across the United States because of large increases in off-label prescribing, many of the drugs’ manufacturers have committed to donating millions of doses and/or stepping up production to meet demand.
Later in this article, Michael H. Pillinger, MD, a rheumatologist and professor of medicine, biochemistry, and molecular pharmacology at NYU Langone Health, New York, answered questions about a new multicenter study called COLCORONA getting underway to test the anti-inflammatory drug colchicine. The answers in this Q&A have been edited for length and clarity.
Questions about hydroxychloroquine shortage
Q: What is the current situation with hydroxychloroquine in your practice?
A: We have been getting calls from our patients asking about getting refills for hydroxychloroquine. Our group has been calling local pharmacies asking about the availability of hydroxychloroquine, and we are compiling a list of pharmacies in New York with current availabilities to share with patients. We are somewhat limited by our electronic health record system, Epic, which can only send a prescription to one pharmacy, so that has placed some limitations on knowing where it is available. Some pharmacies have not had hydroxychloroquine available, while others have. We have also been encouraging patients to check online and look for mail-order possibilities for 90-day supplies.
Nearly all prescriptions are for generic hydroxychloroquine. Branded hydroxychloroquine (Plaquenil) is much more expensive, and we can run into obstacles with getting it approved by insurers, too.
Q: What are you telling patients who seek to refill their prescription or call with concerns? Is it feasible for patients to stop hydroxychloroquine or cut their dosage if necessary?
A: If someone’s been on hydroxychloroquine and has benefited from its use there’s no reason to come off it at this time, and given the possibility that it may have an effect on COVID-19, that is all the better. But we want to reassure patients that they can get the drug and that it is not difficult to manufacture.
Given the significantly higher risk of disease flare that was first described in lupus patients who discontinued hydroxychloroquine in the Canadian Hydroxychloroquine Study Group’s 1991 randomized, controlled trial, it is not advisable for patients to stop the drug.
Some patients do split their dosage day-to-day if they are taking less than 400 mg daily, such that someone taking 300 mg daily may take two 200-mg tablets one day and just one 200-mg tablet the next day, and so on. To avoid eye toxicity that can occur after years of taking the drug, hydroxychloroquine is generally prescribed based on weight at 5 mg/kg.
The drug also stays in the body for quite a while [often up to 3 months and even longer], so that is helpful for patients to know.
Given the current situation and the possibility of its effectiveness against COVID-19, it is ironic that we are actually trying to recruit older lupus patients who have had long-term stable disease while on hydroxychloroquine to a trial of stopping the drug to reduce the risk of developing the side effect of retinopathy. We want to see if patients can safely withdraw hydroxychloroquine without flaring, so we hope to not run into enrollment difficulties based on the current situation with COVID-19.
Q: How do you view the balance between having enough hydroxychloroquine for patients with lupus or other rheumatic diseases and its use in COVID-19 patients?
A: We want to reassure patients that hydroxychloroquine will be available, and there is no reason to hoard the drug or to worry excessively about being unable to obtain it. Efforts to increase production by Mylan, Teva, Sanofi, Novartis, and other manufacturers of hydroxychloroquine should really help out.
Q: Are there pharmacy restrictions on prescription amounts?
A: This is not universal at this time, but some institutions are cutting back and offering only 1-month supplies.
Colchicine COVID-19 trial underway
Dr. Pillinger, of NYU Langone Health, explored the COLCORONA study of colchicine as a treatment for people infected with COVID-19 and the worry that shortage concerns may arise for it, too.
Q: What is the general availability of colchicine and its susceptibility to shortage?
A: There are two major manufacturers of colchicine in the United States, Takeda and Hikma, who together manufacture the majority of the drug.
The greatest use of colchicine in the United States is for gout, which affects approximately 4 million Americans, but the drug is not used chronically, so a much smaller number of patients are using colchicine at any one time. Colchicine is also used for other inflammatory conditions, primarily calcium pyrophosphate crystal disease and familial Mediterranean fever (FMF is rare in the United States). Cardiologists also regularly prescribe colchicine in pericarditis for short-term use. Physicians may use it off label for other purposes, too.
Overall, the number of patients using colchicine is much larger than that for the use of hydroxychloroquine, for example, suggesting that the immediate risk of shortage could be lower. However, if individuals started using it off label, or prescribing inappropriately for the COVID-19 indication, the supply would rapidly run short.
Q: What other points are there to consider regarding the use of colchicine to treat COVID-19?
A: There is no evidence – zero – that colchicine has any benefit for COVID-19, not even case reports. There is some rationale that it might be beneficial, but that is exactly why the COLCORONA trial would be logical to try.
The COLCORONA trial is exactly the kind of trial that would be needed for assessing colchicine, and it is big enough and happening quickly enough to get an answer. But if people start to use colchicine off label, we may never know the truth.
While colchicine can be used safely in most people, it can be very problematic and requires an experienced doctor’s supervision. Overdoses can be fatal, and colchicine interacts with many drugs, all of which require dose adjustment and some of which must be stopped in order to use colchicine – it isn’t candy. Some of the other drugs being looked at for COVID-19 in fact may interact with colchicine.
Colchicine must also be dose adjusted for kidney disease, and, in some of the COVID-19 patients, kidney function changes rapidly. So again, its use would require expert supervision even if there were evidence for its utility.
The side effects of colchicine, if mis-dosed, can be very unpleasant, including nausea, vomiting, and diarrhea. Even at the apparent right dose, some people will get these side effects, so colchicine has to be something that works to make the risk/benefit ratio worth it.
Some preparations of colchicine are made combined with probenecid, a gout drug. This is even more problematic because probenecid can raise the level of drugs excreted by the kidney and could affect other treatments.
So in sum, what may be a good idea in theory can turn out to be a disastrous idea in practice, and here we have nothing but theory. This is not an agent to use randomly; the studies will be rushed out quickly and hopefully will give us the knowledge to know what to do.
Dr. Izmirly and Dr. Buyon said they have research grants with the National Institutes of Health to study hydroxychloroquine in patients with lupus and in anti–SSA/Ro-positive pregnant women with a previous child with congenital heart block. Dr. Pillinger reports that he has an investigator-initiated grant from Hikma to study colchicine in osteoarthritis.
This article was reformatted on 3/30/2020 for clarity.
Physicians pessimistic despite increased COVID-19 test kits
according to a survey.
One positive finding from the physicians who participated in this survey March 19-20 was that the availability of COVID-19 test kits has more than doubled since late February.
Reported access to test kits went from 31% in the first wave of a series of surveys (Jan. 31–Feb. 4), down to 20% in the second (Feb. 26-27), and then jumped to 67% by the third wave (March 19-20), InCrowd reported March 26.
Views on several other COVID-related topics were negative among the majority of responding physicians – all of whom had or were currently treating 20 or more patients with flu-like symptoms at the time of the survey.
“Their frustrations and concerns about their ability to protect themselves while meeting upcoming patient care levels has increased significantly in the last 3 months,” Daniel S. Fitzgerald, CEO and president of InCrowd, said in a written statement.
In the third wave, 78% of respondents were “concerned for the safety of loved ones due to my exposure as a physician to COVID-19” and only 16% believed that their facility was “staffed adequately to treat the influx of patients anticipated in the next 30 days,” InCrowd said.
One primary care physician from California elaborated on the issue of safety equipment: “First, [the CDC] said we need N95 masks and other masks would not protect us. As those are running out then they said just use regular surgical masks. Now they are saying use bandannas and scarves! It’s like they don’t care about the safety of the people who will be treating the ill! We don’t want to bring it home to our families!”
“Overall, morale appears low, with few optimistic about the efficacy of public-private collaboration (21%), their own safety given current PPE [personal protective equipment] supply (13%), and the U.S.’s ability to ‘flatten the curve’ (12%),” InCrowd noted in the report.
The first two waves each had 150 respondents, but the number increased to 263 for wave 3, with similar proportions – about 50% emergency medicine or critical care specialists, 25% pediatricians, and 25% primary care physicians – in all three.
according to a survey.
One positive finding from the physicians who participated in this survey March 19-20 was that the availability of COVID-19 test kits has more than doubled since late February.
Reported access to test kits went from 31% in the first wave of a series of surveys (Jan. 31–Feb. 4), down to 20% in the second (Feb. 26-27), and then jumped to 67% by the third wave (March 19-20), InCrowd reported March 26.
Views on several other COVID-related topics were negative among the majority of responding physicians – all of whom had or were currently treating 20 or more patients with flu-like symptoms at the time of the survey.
“Their frustrations and concerns about their ability to protect themselves while meeting upcoming patient care levels has increased significantly in the last 3 months,” Daniel S. Fitzgerald, CEO and president of InCrowd, said in a written statement.
In the third wave, 78% of respondents were “concerned for the safety of loved ones due to my exposure as a physician to COVID-19” and only 16% believed that their facility was “staffed adequately to treat the influx of patients anticipated in the next 30 days,” InCrowd said.
One primary care physician from California elaborated on the issue of safety equipment: “First, [the CDC] said we need N95 masks and other masks would not protect us. As those are running out then they said just use regular surgical masks. Now they are saying use bandannas and scarves! It’s like they don’t care about the safety of the people who will be treating the ill! We don’t want to bring it home to our families!”
“Overall, morale appears low, with few optimistic about the efficacy of public-private collaboration (21%), their own safety given current PPE [personal protective equipment] supply (13%), and the U.S.’s ability to ‘flatten the curve’ (12%),” InCrowd noted in the report.
The first two waves each had 150 respondents, but the number increased to 263 for wave 3, with similar proportions – about 50% emergency medicine or critical care specialists, 25% pediatricians, and 25% primary care physicians – in all three.
according to a survey.
One positive finding from the physicians who participated in this survey March 19-20 was that the availability of COVID-19 test kits has more than doubled since late February.
Reported access to test kits went from 31% in the first wave of a series of surveys (Jan. 31–Feb. 4), down to 20% in the second (Feb. 26-27), and then jumped to 67% by the third wave (March 19-20), InCrowd reported March 26.
Views on several other COVID-related topics were negative among the majority of responding physicians – all of whom had or were currently treating 20 or more patients with flu-like symptoms at the time of the survey.
“Their frustrations and concerns about their ability to protect themselves while meeting upcoming patient care levels has increased significantly in the last 3 months,” Daniel S. Fitzgerald, CEO and president of InCrowd, said in a written statement.
In the third wave, 78% of respondents were “concerned for the safety of loved ones due to my exposure as a physician to COVID-19” and only 16% believed that their facility was “staffed adequately to treat the influx of patients anticipated in the next 30 days,” InCrowd said.
One primary care physician from California elaborated on the issue of safety equipment: “First, [the CDC] said we need N95 masks and other masks would not protect us. As those are running out then they said just use regular surgical masks. Now they are saying use bandannas and scarves! It’s like they don’t care about the safety of the people who will be treating the ill! We don’t want to bring it home to our families!”
“Overall, morale appears low, with few optimistic about the efficacy of public-private collaboration (21%), their own safety given current PPE [personal protective equipment] supply (13%), and the U.S.’s ability to ‘flatten the curve’ (12%),” InCrowd noted in the report.
The first two waves each had 150 respondents, but the number increased to 263 for wave 3, with similar proportions – about 50% emergency medicine or critical care specialists, 25% pediatricians, and 25% primary care physicians – in all three.
Keep calm: Under 25s with diabetes aren't being hospitalized for COVID-19
Reports from pediatric endocrinologists in COVID-19 hot spots globally indicate that children, adolescents, and young adults with diabetes have so far not shown a different disease pattern with the virus compared to children and younger people who do not have diabetes.
Indeed, to date [as of March 24]” according to a new statement from the International Society for Pediatric and Adolescent Diabetes (ISPAD), which currently has about 1,300 members around the globe and has instituted a discussion forum about the topic of treating children with both diabetes and COVID-19.
“We find these reports [from colleagues around the world], though anecdotal, to be reassuring,” it notes. However, there are real worries regarding other potentially dangerous effects. ISPAD has expressed concern, for example, that the COVID-19 pandemic will prevent youngsters with existing diabetes who are having diabetic emergencies from seeking hospital care.
Chinese physicians have reported to ISPAD a number of cases of delayed hospital admissions for diabetic ketoacidosis (DKA) in children with known type 1 diabetes because hospital services were closed for non–COVID-19 care.
Andrea Scaramuzza, MD, a pediatric endocrinologist at Ospedale Maggiore di Cremona, Italy, has similarly reported multiple cases of patients presenting to emergency services there with severe DKA.
“These experiences reinforce the importance of continued attentiveness to standard diabetes care to avoid the need for hospitalization and emergency or urgent care visits,” says ISPAD, under the strapline: “Keep calm and mind your diabetes care.”
But it nevertheless stresses that these resources should be used “if needed.”
Worries that new-onset diabetes will be missed during COVID-19
Dr. Scaramuzza said in an interview that there also are concerns regarding delays in diagnoses of new cases of type 1 diabetes “due to the fear families have to go to the emergency department because of COVID-19.”
Indeed, in Italy, a few patients have arrived with very serious DKA, he said. Dr. Scaramuzza noted a colleague from Naples, Dario Iafusco, MD, and colleagues have made a video to keep awareness high regarding new-onset diabetes.
“This coronavirus pandemic can be defeated if you stay at home, but if you know of a child who has excessive thirst, frequent urination, or who starts vomiting,” seek health care advice immediately. “This child could have [type 1] diabetes. Prevent severe DKA, or worse, death,” Dr. Iafusco of the Regional Centre of Paediatric Diabetology G.Stoppoloni Via S. Andrea delle Dame, Naples, said in the video.
Physicians from China have similar observations, reporting to ISPAD several cases of delayed admissions of newly diagnosed type 1 diabetes because hospital services were closed for non–COVID-19 care.
Keep calm and mind your diabetes care; physicians use telemedicine
Meanwhile, last week ISPAD issued guidance for young people with diabetes and their carers about what to do if COVID-19 infection is suspected.
Most advice is the same as for the general public because reports of COVID-19 infection suggest it is much less severe in children and adolescents, and the summary currently serves “as reassurance that youth with diabetes are not more affected by COVID-19 than peers,” it adds.
“Our approach to treating a child with diabetes would be to follow the ISPAD sick-day guidelines, which provide generalized diabetes management in any flu-like illness. We wouldn’t do anything very different right now,” one of the authors, Jamie Wood, MD, associate professor of clinical pediatrics at Case Western Reserve University, Cleveland, said in an interview.
“Any illness makes diabetes more difficult to manage and can increase the risk of DKA,” she emphasized.
“We would reinforce frequent monitoring of blood glucose and ketone levels, to never stop insulin – in fact, when most people are ill, the body is stressed and requires more insulin – and to stay hydrated and treat the underlying symptoms.”
And make sure to “treat the fever,” she stressed. “When patients with type 1 diabetes get fever, they have a tendency to make more ketones, so we recommend aggressive control of fever.”
ISPAD recommends young people aim to keep blood glucose levels between 4 and 10 mmol/L (72-180 mg/dL) and blood ketones below 0.6 mmol/L (10.8 mg/dL) during illness and to never stop insulin.
Guidance is provided on when to seek urgent specialist advice with possible referral to emergency care, for example, in cases in which the patient has DKA symptoms, such as persistent and/or worsened fruity breath odor or vomiting.
Dr. Scaramuzza said in an interview that, in Italy, he and his colleagues have increased their use of telemedicine to keep monitoring their patients with diabetes even from a distance and that it was working very well.
“Technology – such as downloading [records from] insulin pumps, continuous glucose monitoring systems, and the possibility to use Skype or other platforms – really helps,” he noted.
“There has been a rapid increase in telehealth as a way to continue to care for youth with diabetes and decrease risk for infection,” said ISPAD.
“Communication between patients, families, and health care teams is vitally important. Methods to do so that avoid visits to clinics or hospitals can provide needed diabetes advice and reduce risk for COVID-19 transmission.”
A version of this article originally appeared on Medscape.com.
Reports from pediatric endocrinologists in COVID-19 hot spots globally indicate that children, adolescents, and young adults with diabetes have so far not shown a different disease pattern with the virus compared to children and younger people who do not have diabetes.
Indeed, to date [as of March 24]” according to a new statement from the International Society for Pediatric and Adolescent Diabetes (ISPAD), which currently has about 1,300 members around the globe and has instituted a discussion forum about the topic of treating children with both diabetes and COVID-19.
“We find these reports [from colleagues around the world], though anecdotal, to be reassuring,” it notes. However, there are real worries regarding other potentially dangerous effects. ISPAD has expressed concern, for example, that the COVID-19 pandemic will prevent youngsters with existing diabetes who are having diabetic emergencies from seeking hospital care.
Chinese physicians have reported to ISPAD a number of cases of delayed hospital admissions for diabetic ketoacidosis (DKA) in children with known type 1 diabetes because hospital services were closed for non–COVID-19 care.
Andrea Scaramuzza, MD, a pediatric endocrinologist at Ospedale Maggiore di Cremona, Italy, has similarly reported multiple cases of patients presenting to emergency services there with severe DKA.
“These experiences reinforce the importance of continued attentiveness to standard diabetes care to avoid the need for hospitalization and emergency or urgent care visits,” says ISPAD, under the strapline: “Keep calm and mind your diabetes care.”
But it nevertheless stresses that these resources should be used “if needed.”
Worries that new-onset diabetes will be missed during COVID-19
Dr. Scaramuzza said in an interview that there also are concerns regarding delays in diagnoses of new cases of type 1 diabetes “due to the fear families have to go to the emergency department because of COVID-19.”
Indeed, in Italy, a few patients have arrived with very serious DKA, he said. Dr. Scaramuzza noted a colleague from Naples, Dario Iafusco, MD, and colleagues have made a video to keep awareness high regarding new-onset diabetes.
“This coronavirus pandemic can be defeated if you stay at home, but if you know of a child who has excessive thirst, frequent urination, or who starts vomiting,” seek health care advice immediately. “This child could have [type 1] diabetes. Prevent severe DKA, or worse, death,” Dr. Iafusco of the Regional Centre of Paediatric Diabetology G.Stoppoloni Via S. Andrea delle Dame, Naples, said in the video.
Physicians from China have similar observations, reporting to ISPAD several cases of delayed admissions of newly diagnosed type 1 diabetes because hospital services were closed for non–COVID-19 care.
Keep calm and mind your diabetes care; physicians use telemedicine
Meanwhile, last week ISPAD issued guidance for young people with diabetes and their carers about what to do if COVID-19 infection is suspected.
Most advice is the same as for the general public because reports of COVID-19 infection suggest it is much less severe in children and adolescents, and the summary currently serves “as reassurance that youth with diabetes are not more affected by COVID-19 than peers,” it adds.
“Our approach to treating a child with diabetes would be to follow the ISPAD sick-day guidelines, which provide generalized diabetes management in any flu-like illness. We wouldn’t do anything very different right now,” one of the authors, Jamie Wood, MD, associate professor of clinical pediatrics at Case Western Reserve University, Cleveland, said in an interview.
“Any illness makes diabetes more difficult to manage and can increase the risk of DKA,” she emphasized.
“We would reinforce frequent monitoring of blood glucose and ketone levels, to never stop insulin – in fact, when most people are ill, the body is stressed and requires more insulin – and to stay hydrated and treat the underlying symptoms.”
And make sure to “treat the fever,” she stressed. “When patients with type 1 diabetes get fever, they have a tendency to make more ketones, so we recommend aggressive control of fever.”
ISPAD recommends young people aim to keep blood glucose levels between 4 and 10 mmol/L (72-180 mg/dL) and blood ketones below 0.6 mmol/L (10.8 mg/dL) during illness and to never stop insulin.
Guidance is provided on when to seek urgent specialist advice with possible referral to emergency care, for example, in cases in which the patient has DKA symptoms, such as persistent and/or worsened fruity breath odor or vomiting.
Dr. Scaramuzza said in an interview that, in Italy, he and his colleagues have increased their use of telemedicine to keep monitoring their patients with diabetes even from a distance and that it was working very well.
“Technology – such as downloading [records from] insulin pumps, continuous glucose monitoring systems, and the possibility to use Skype or other platforms – really helps,” he noted.
“There has been a rapid increase in telehealth as a way to continue to care for youth with diabetes and decrease risk for infection,” said ISPAD.
“Communication between patients, families, and health care teams is vitally important. Methods to do so that avoid visits to clinics or hospitals can provide needed diabetes advice and reduce risk for COVID-19 transmission.”
A version of this article originally appeared on Medscape.com.
Reports from pediatric endocrinologists in COVID-19 hot spots globally indicate that children, adolescents, and young adults with diabetes have so far not shown a different disease pattern with the virus compared to children and younger people who do not have diabetes.
Indeed, to date [as of March 24]” according to a new statement from the International Society for Pediatric and Adolescent Diabetes (ISPAD), which currently has about 1,300 members around the globe and has instituted a discussion forum about the topic of treating children with both diabetes and COVID-19.
“We find these reports [from colleagues around the world], though anecdotal, to be reassuring,” it notes. However, there are real worries regarding other potentially dangerous effects. ISPAD has expressed concern, for example, that the COVID-19 pandemic will prevent youngsters with existing diabetes who are having diabetic emergencies from seeking hospital care.
Chinese physicians have reported to ISPAD a number of cases of delayed hospital admissions for diabetic ketoacidosis (DKA) in children with known type 1 diabetes because hospital services were closed for non–COVID-19 care.
Andrea Scaramuzza, MD, a pediatric endocrinologist at Ospedale Maggiore di Cremona, Italy, has similarly reported multiple cases of patients presenting to emergency services there with severe DKA.
“These experiences reinforce the importance of continued attentiveness to standard diabetes care to avoid the need for hospitalization and emergency or urgent care visits,” says ISPAD, under the strapline: “Keep calm and mind your diabetes care.”
But it nevertheless stresses that these resources should be used “if needed.”
Worries that new-onset diabetes will be missed during COVID-19
Dr. Scaramuzza said in an interview that there also are concerns regarding delays in diagnoses of new cases of type 1 diabetes “due to the fear families have to go to the emergency department because of COVID-19.”
Indeed, in Italy, a few patients have arrived with very serious DKA, he said. Dr. Scaramuzza noted a colleague from Naples, Dario Iafusco, MD, and colleagues have made a video to keep awareness high regarding new-onset diabetes.
“This coronavirus pandemic can be defeated if you stay at home, but if you know of a child who has excessive thirst, frequent urination, or who starts vomiting,” seek health care advice immediately. “This child could have [type 1] diabetes. Prevent severe DKA, or worse, death,” Dr. Iafusco of the Regional Centre of Paediatric Diabetology G.Stoppoloni Via S. Andrea delle Dame, Naples, said in the video.
Physicians from China have similar observations, reporting to ISPAD several cases of delayed admissions of newly diagnosed type 1 diabetes because hospital services were closed for non–COVID-19 care.
Keep calm and mind your diabetes care; physicians use telemedicine
Meanwhile, last week ISPAD issued guidance for young people with diabetes and their carers about what to do if COVID-19 infection is suspected.
Most advice is the same as for the general public because reports of COVID-19 infection suggest it is much less severe in children and adolescents, and the summary currently serves “as reassurance that youth with diabetes are not more affected by COVID-19 than peers,” it adds.
“Our approach to treating a child with diabetes would be to follow the ISPAD sick-day guidelines, which provide generalized diabetes management in any flu-like illness. We wouldn’t do anything very different right now,” one of the authors, Jamie Wood, MD, associate professor of clinical pediatrics at Case Western Reserve University, Cleveland, said in an interview.
“Any illness makes diabetes more difficult to manage and can increase the risk of DKA,” she emphasized.
“We would reinforce frequent monitoring of blood glucose and ketone levels, to never stop insulin – in fact, when most people are ill, the body is stressed and requires more insulin – and to stay hydrated and treat the underlying symptoms.”
And make sure to “treat the fever,” she stressed. “When patients with type 1 diabetes get fever, they have a tendency to make more ketones, so we recommend aggressive control of fever.”
ISPAD recommends young people aim to keep blood glucose levels between 4 and 10 mmol/L (72-180 mg/dL) and blood ketones below 0.6 mmol/L (10.8 mg/dL) during illness and to never stop insulin.
Guidance is provided on when to seek urgent specialist advice with possible referral to emergency care, for example, in cases in which the patient has DKA symptoms, such as persistent and/or worsened fruity breath odor or vomiting.
Dr. Scaramuzza said in an interview that, in Italy, he and his colleagues have increased their use of telemedicine to keep monitoring their patients with diabetes even from a distance and that it was working very well.
“Technology – such as downloading [records from] insulin pumps, continuous glucose monitoring systems, and the possibility to use Skype or other platforms – really helps,” he noted.
“There has been a rapid increase in telehealth as a way to continue to care for youth with diabetes and decrease risk for infection,” said ISPAD.
“Communication between patients, families, and health care teams is vitally important. Methods to do so that avoid visits to clinics or hospitals can provide needed diabetes advice and reduce risk for COVID-19 transmission.”
A version of this article originally appeared on Medscape.com.
Guidelines on delaying cancer surgery during COVID-19
Cancer surgeries may need to be delayed as hospitals are forced to allocate resources to a surge of COVID-19 patients, says the American College of Surgeons, as it issues a new set of recommendations in reaction to the crisis.
Most surgeons have already curtailed or have ceased to perform elective operations, the ACS notes, and recommends that surgeons continue to do so in order to preserve the necessary resources for care of critically ill patients during the COVID-19 pandemic. The new clinical guidance for elective surgical case triage during the pandemic includes recommendations for cancer surgery as well as for procedures that are specific to certain cancer types.
“These triage guidelines and joint recommendations are being issued as we appear to be entering a new phase of the COVID-19 pandemic with more hospitals facing a potential push beyond their resources to care for critically ill patients,” commented ACS Executive Director David B. Hoyt, MD, in a statement.
“ACS will continue to monitor the landscape for surgical care but we feel this guidance document provides a good foundation for surgeons to begin enacting these triage recommendations today to help them make the best decisions possible for their patients during COVID-19,” he said.
For cancer surgery, which is often not elective but essential to treatment, ACS has issued general guidance for triaging patients, taking into account the acuity of the local COVID-19 situation.
First, decisions about whether to proceed with elective surgeries must consider the available resources of local facilities. The parties responsible for preparing the facility to manage coronavirus patients should be sharing information at regular intervals about constraints on local resources, especially personal protective equipment (PPE), which is running low in many jurisdictions. For example, if an elective case has a high likelihood of needing postoperative ICU care, it is imperative to balance the risk of delay against the need of availability for patients with COVID-19.
Second, cancer care coordination should use virtual technologies as much as possible, and facilities with tumor boards may find it helpful to locate multidisciplinary experts by virtual means, to assist with decision making and establishing triage criteria.
Three Phases of Pandemic
The ACS has also organized decision making into three phases that reflect the acuity of the local COVID-19 situation:
- Phase I. Semi-Urgent Setting (Preparation Phase) – few COVID-19 patients, hospital resources not exhausted, institution still has ICU ventilator capacity and COVID-19 trajectory not in rapid escalation phase
- Phase II. Urgent Setting – many COVID-19 patients, ICU and ventilator capacity limited, operating room supplies limited
- Phase III. Hospital resources are all routed to COVID-19 patients, no ventilator or ICU capacity, operating room supplies exhausted; patients in whom death is likely within hours if surgery is deferred
Breast Cancer Surgery
The ACS also issued specific guidance for several tumor types, including guidance for breast cancer surgery.
For phase I, surgery should be restricted to patients who are likely to experience compromised survival if it is not performed within next 3 months. This includes patients completing neoadjuvant treatment, those with clinical stage T2 or N1 ERpos/PRpos/HER2-negative tumors, patients with triple negative or HER2-positive tumors, discordant biopsies that are likely to be malignant, and removal of a recurrent lesion.
Phase II would be restricted to patients whose survival is threatened if surgery is not performed within the next few days. These would include incision and drainage of breast abscess, evacuating a hematoma, revision of an ischemic mastectomy flap, and revascularization/revision of an autologous tissue flap (autologous reconstruction should be deferred).
In Phase III, surgical procedures would be restricted to patients who may not survive if surgery is not performed within a few hours. This includes incision and drainage of breast abscess, evacuation of a hematoma, revision of an ischemic mastectomy flap, and revascularization/revision of an autologous tissue flap (autologous reconstruction should be deferred).
Colorectal Cancer Surgery
Guidance for colorectal cancer surgery is also split into the three phases of the pandemic.
Phase I would include cases needing surgical intervention as soon as feasible, while recognizing that the status of each hospital is likely to evolve over the next week or two. These patients would include those with nearly obstructing colon cancer or rectal cancer; cancers that require frequent transfusions; asymptomatic colon cancers; rectal cancers that do not respond to neoadjuvant chemoradiation; malignancies with a risk of local perforation and sepsis; and those with early stage rectal cancers that are not candidates for adjuvant therapy.
Phase II comprises patients needing surgery as soon as feasible, but recognizing that hospital status is likely to progress over the next few days. These cases include patients with a nearly obstructing colon cancer where stenting is not an option; those with nearly obstructing rectal cancer (should be diverted); cancers with high (inpatient) transfusion requirements; and cancers with pending evidence of local perforation and sepsis.
All colorectal procedures typically scheduled as routine should be delayed.
In Phase III, if the status of the facility is likely to progress within hours, the only surgery that should be performed would be for perforated, obstructed, or actively bleeding (inpatient transfusion dependent) cancers or those with sepsis. All other surgeries should be deferred.
Thoracic Cancer Surgery
Thoracic cancer surgery guidelines follow those for breast cancer. Phase I should be restricted to patients whose survival may be impacted if surgery is not performed within next 3 months. These include:
- Cases with solid or predominantly solid (>50%) lung cancer or presumed lung cancer (>2 cm), clinical node negative
- Node positive lung cancer
- Post-induction therapy cancer
- Esophageal cancer T1b or greater
- Chest wall tumors that are potentially aggressive and not manageable by alternative means
- Stenting for obstructing esophageal tumor
- Staging to start treatment (mediastinoscopy, diagnostic VATS for pleural dissemination)
- Symptomatic mediastinal tumors
- Patients who are enrolled in therapeutic clinical trials.
Phase II would permit surgery if survival will be impacted by a delay of a few days. These cases would include nonseptic perforated cancer of esophagus, a tumor-associated infection, and management of surgical complications in a hemodynamically stable patient.
All thoracic procedures considered to be routine/elective would be deferred.
Phase III restricts surgery to patients whose survival will be compromised if they do not undergo surgery within the next few hours. This group would include perforated cancer of esophagus in a septic patient, a patient with a threatened airway, sepsis associated with the cancer, and management of surgical complications in an unstable patient (active bleeding that requires surgery, dehiscence of airway, anastomotic leak with sepsis).
All other cases would be deferred.
Other Cancer Types
Although the ACS doesn’t have specific guidelines for all cancer types, a few are included in their general recommendations for the specialty.
For gynecologic surgeries, ACS lists cancer or suspected cancer as indications where significantly delayed surgery could cause “significant harm.”
Delays, in general, are not recommended for neurosurgery, which would include brain cancers. In pediatrics, most cancer surgery is considered “urgent,” where a delay of days to weeks could prove detrimental to the patient. This would comprise all solid tumors, including the initial biopsy and resection following neoadjuvant therapy.
This article first appeared on Medscape.com.
Cancer surgeries may need to be delayed as hospitals are forced to allocate resources to a surge of COVID-19 patients, says the American College of Surgeons, as it issues a new set of recommendations in reaction to the crisis.
Most surgeons have already curtailed or have ceased to perform elective operations, the ACS notes, and recommends that surgeons continue to do so in order to preserve the necessary resources for care of critically ill patients during the COVID-19 pandemic. The new clinical guidance for elective surgical case triage during the pandemic includes recommendations for cancer surgery as well as for procedures that are specific to certain cancer types.
“These triage guidelines and joint recommendations are being issued as we appear to be entering a new phase of the COVID-19 pandemic with more hospitals facing a potential push beyond their resources to care for critically ill patients,” commented ACS Executive Director David B. Hoyt, MD, in a statement.
“ACS will continue to monitor the landscape for surgical care but we feel this guidance document provides a good foundation for surgeons to begin enacting these triage recommendations today to help them make the best decisions possible for their patients during COVID-19,” he said.
For cancer surgery, which is often not elective but essential to treatment, ACS has issued general guidance for triaging patients, taking into account the acuity of the local COVID-19 situation.
First, decisions about whether to proceed with elective surgeries must consider the available resources of local facilities. The parties responsible for preparing the facility to manage coronavirus patients should be sharing information at regular intervals about constraints on local resources, especially personal protective equipment (PPE), which is running low in many jurisdictions. For example, if an elective case has a high likelihood of needing postoperative ICU care, it is imperative to balance the risk of delay against the need of availability for patients with COVID-19.
Second, cancer care coordination should use virtual technologies as much as possible, and facilities with tumor boards may find it helpful to locate multidisciplinary experts by virtual means, to assist with decision making and establishing triage criteria.
Three Phases of Pandemic
The ACS has also organized decision making into three phases that reflect the acuity of the local COVID-19 situation:
- Phase I. Semi-Urgent Setting (Preparation Phase) – few COVID-19 patients, hospital resources not exhausted, institution still has ICU ventilator capacity and COVID-19 trajectory not in rapid escalation phase
- Phase II. Urgent Setting – many COVID-19 patients, ICU and ventilator capacity limited, operating room supplies limited
- Phase III. Hospital resources are all routed to COVID-19 patients, no ventilator or ICU capacity, operating room supplies exhausted; patients in whom death is likely within hours if surgery is deferred
Breast Cancer Surgery
The ACS also issued specific guidance for several tumor types, including guidance for breast cancer surgery.
For phase I, surgery should be restricted to patients who are likely to experience compromised survival if it is not performed within next 3 months. This includes patients completing neoadjuvant treatment, those with clinical stage T2 or N1 ERpos/PRpos/HER2-negative tumors, patients with triple negative or HER2-positive tumors, discordant biopsies that are likely to be malignant, and removal of a recurrent lesion.
Phase II would be restricted to patients whose survival is threatened if surgery is not performed within the next few days. These would include incision and drainage of breast abscess, evacuating a hematoma, revision of an ischemic mastectomy flap, and revascularization/revision of an autologous tissue flap (autologous reconstruction should be deferred).
In Phase III, surgical procedures would be restricted to patients who may not survive if surgery is not performed within a few hours. This includes incision and drainage of breast abscess, evacuation of a hematoma, revision of an ischemic mastectomy flap, and revascularization/revision of an autologous tissue flap (autologous reconstruction should be deferred).
Colorectal Cancer Surgery
Guidance for colorectal cancer surgery is also split into the three phases of the pandemic.
Phase I would include cases needing surgical intervention as soon as feasible, while recognizing that the status of each hospital is likely to evolve over the next week or two. These patients would include those with nearly obstructing colon cancer or rectal cancer; cancers that require frequent transfusions; asymptomatic colon cancers; rectal cancers that do not respond to neoadjuvant chemoradiation; malignancies with a risk of local perforation and sepsis; and those with early stage rectal cancers that are not candidates for adjuvant therapy.
Phase II comprises patients needing surgery as soon as feasible, but recognizing that hospital status is likely to progress over the next few days. These cases include patients with a nearly obstructing colon cancer where stenting is not an option; those with nearly obstructing rectal cancer (should be diverted); cancers with high (inpatient) transfusion requirements; and cancers with pending evidence of local perforation and sepsis.
All colorectal procedures typically scheduled as routine should be delayed.
In Phase III, if the status of the facility is likely to progress within hours, the only surgery that should be performed would be for perforated, obstructed, or actively bleeding (inpatient transfusion dependent) cancers or those with sepsis. All other surgeries should be deferred.
Thoracic Cancer Surgery
Thoracic cancer surgery guidelines follow those for breast cancer. Phase I should be restricted to patients whose survival may be impacted if surgery is not performed within next 3 months. These include:
- Cases with solid or predominantly solid (>50%) lung cancer or presumed lung cancer (>2 cm), clinical node negative
- Node positive lung cancer
- Post-induction therapy cancer
- Esophageal cancer T1b or greater
- Chest wall tumors that are potentially aggressive and not manageable by alternative means
- Stenting for obstructing esophageal tumor
- Staging to start treatment (mediastinoscopy, diagnostic VATS for pleural dissemination)
- Symptomatic mediastinal tumors
- Patients who are enrolled in therapeutic clinical trials.
Phase II would permit surgery if survival will be impacted by a delay of a few days. These cases would include nonseptic perforated cancer of esophagus, a tumor-associated infection, and management of surgical complications in a hemodynamically stable patient.
All thoracic procedures considered to be routine/elective would be deferred.
Phase III restricts surgery to patients whose survival will be compromised if they do not undergo surgery within the next few hours. This group would include perforated cancer of esophagus in a septic patient, a patient with a threatened airway, sepsis associated with the cancer, and management of surgical complications in an unstable patient (active bleeding that requires surgery, dehiscence of airway, anastomotic leak with sepsis).
All other cases would be deferred.
Other Cancer Types
Although the ACS doesn’t have specific guidelines for all cancer types, a few are included in their general recommendations for the specialty.
For gynecologic surgeries, ACS lists cancer or suspected cancer as indications where significantly delayed surgery could cause “significant harm.”
Delays, in general, are not recommended for neurosurgery, which would include brain cancers. In pediatrics, most cancer surgery is considered “urgent,” where a delay of days to weeks could prove detrimental to the patient. This would comprise all solid tumors, including the initial biopsy and resection following neoadjuvant therapy.
This article first appeared on Medscape.com.
Cancer surgeries may need to be delayed as hospitals are forced to allocate resources to a surge of COVID-19 patients, says the American College of Surgeons, as it issues a new set of recommendations in reaction to the crisis.
Most surgeons have already curtailed or have ceased to perform elective operations, the ACS notes, and recommends that surgeons continue to do so in order to preserve the necessary resources for care of critically ill patients during the COVID-19 pandemic. The new clinical guidance for elective surgical case triage during the pandemic includes recommendations for cancer surgery as well as for procedures that are specific to certain cancer types.
“These triage guidelines and joint recommendations are being issued as we appear to be entering a new phase of the COVID-19 pandemic with more hospitals facing a potential push beyond their resources to care for critically ill patients,” commented ACS Executive Director David B. Hoyt, MD, in a statement.
“ACS will continue to monitor the landscape for surgical care but we feel this guidance document provides a good foundation for surgeons to begin enacting these triage recommendations today to help them make the best decisions possible for their patients during COVID-19,” he said.
For cancer surgery, which is often not elective but essential to treatment, ACS has issued general guidance for triaging patients, taking into account the acuity of the local COVID-19 situation.
First, decisions about whether to proceed with elective surgeries must consider the available resources of local facilities. The parties responsible for preparing the facility to manage coronavirus patients should be sharing information at regular intervals about constraints on local resources, especially personal protective equipment (PPE), which is running low in many jurisdictions. For example, if an elective case has a high likelihood of needing postoperative ICU care, it is imperative to balance the risk of delay against the need of availability for patients with COVID-19.
Second, cancer care coordination should use virtual technologies as much as possible, and facilities with tumor boards may find it helpful to locate multidisciplinary experts by virtual means, to assist with decision making and establishing triage criteria.
Three Phases of Pandemic
The ACS has also organized decision making into three phases that reflect the acuity of the local COVID-19 situation:
- Phase I. Semi-Urgent Setting (Preparation Phase) – few COVID-19 patients, hospital resources not exhausted, institution still has ICU ventilator capacity and COVID-19 trajectory not in rapid escalation phase
- Phase II. Urgent Setting – many COVID-19 patients, ICU and ventilator capacity limited, operating room supplies limited
- Phase III. Hospital resources are all routed to COVID-19 patients, no ventilator or ICU capacity, operating room supplies exhausted; patients in whom death is likely within hours if surgery is deferred
Breast Cancer Surgery
The ACS also issued specific guidance for several tumor types, including guidance for breast cancer surgery.
For phase I, surgery should be restricted to patients who are likely to experience compromised survival if it is not performed within next 3 months. This includes patients completing neoadjuvant treatment, those with clinical stage T2 or N1 ERpos/PRpos/HER2-negative tumors, patients with triple negative or HER2-positive tumors, discordant biopsies that are likely to be malignant, and removal of a recurrent lesion.
Phase II would be restricted to patients whose survival is threatened if surgery is not performed within the next few days. These would include incision and drainage of breast abscess, evacuating a hematoma, revision of an ischemic mastectomy flap, and revascularization/revision of an autologous tissue flap (autologous reconstruction should be deferred).
In Phase III, surgical procedures would be restricted to patients who may not survive if surgery is not performed within a few hours. This includes incision and drainage of breast abscess, evacuation of a hematoma, revision of an ischemic mastectomy flap, and revascularization/revision of an autologous tissue flap (autologous reconstruction should be deferred).
Colorectal Cancer Surgery
Guidance for colorectal cancer surgery is also split into the three phases of the pandemic.
Phase I would include cases needing surgical intervention as soon as feasible, while recognizing that the status of each hospital is likely to evolve over the next week or two. These patients would include those with nearly obstructing colon cancer or rectal cancer; cancers that require frequent transfusions; asymptomatic colon cancers; rectal cancers that do not respond to neoadjuvant chemoradiation; malignancies with a risk of local perforation and sepsis; and those with early stage rectal cancers that are not candidates for adjuvant therapy.
Phase II comprises patients needing surgery as soon as feasible, but recognizing that hospital status is likely to progress over the next few days. These cases include patients with a nearly obstructing colon cancer where stenting is not an option; those with nearly obstructing rectal cancer (should be diverted); cancers with high (inpatient) transfusion requirements; and cancers with pending evidence of local perforation and sepsis.
All colorectal procedures typically scheduled as routine should be delayed.
In Phase III, if the status of the facility is likely to progress within hours, the only surgery that should be performed would be for perforated, obstructed, or actively bleeding (inpatient transfusion dependent) cancers or those with sepsis. All other surgeries should be deferred.
Thoracic Cancer Surgery
Thoracic cancer surgery guidelines follow those for breast cancer. Phase I should be restricted to patients whose survival may be impacted if surgery is not performed within next 3 months. These include:
- Cases with solid or predominantly solid (>50%) lung cancer or presumed lung cancer (>2 cm), clinical node negative
- Node positive lung cancer
- Post-induction therapy cancer
- Esophageal cancer T1b or greater
- Chest wall tumors that are potentially aggressive and not manageable by alternative means
- Stenting for obstructing esophageal tumor
- Staging to start treatment (mediastinoscopy, diagnostic VATS for pleural dissemination)
- Symptomatic mediastinal tumors
- Patients who are enrolled in therapeutic clinical trials.
Phase II would permit surgery if survival will be impacted by a delay of a few days. These cases would include nonseptic perforated cancer of esophagus, a tumor-associated infection, and management of surgical complications in a hemodynamically stable patient.
All thoracic procedures considered to be routine/elective would be deferred.
Phase III restricts surgery to patients whose survival will be compromised if they do not undergo surgery within the next few hours. This group would include perforated cancer of esophagus in a septic patient, a patient with a threatened airway, sepsis associated with the cancer, and management of surgical complications in an unstable patient (active bleeding that requires surgery, dehiscence of airway, anastomotic leak with sepsis).
All other cases would be deferred.
Other Cancer Types
Although the ACS doesn’t have specific guidelines for all cancer types, a few are included in their general recommendations for the specialty.
For gynecologic surgeries, ACS lists cancer or suspected cancer as indications where significantly delayed surgery could cause “significant harm.”
Delays, in general, are not recommended for neurosurgery, which would include brain cancers. In pediatrics, most cancer surgery is considered “urgent,” where a delay of days to weeks could prove detrimental to the patient. This would comprise all solid tumors, including the initial biopsy and resection following neoadjuvant therapy.
This article first appeared on Medscape.com.