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Common MS treatment wears off more quickly in Black patients

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Black patients with multiple sclerosis (MS) or neuromyelitis optica spectrum disorder (NMOSD) may respond differently to common MS treatment compared to their White peers, new research suggests. In a study of almost 200 patients, Black participants with MS or NMOSD showed significantly more rapid B-cell repopulation 6-12 months after receiving anti-CD20 infusion therapy with rituximab or ocrelizumab (Rituxan, Ocrevus, Genentech) than did White participants.

Dr. Gregg Silverman

“The results showed that this B-cell targeted therapy wore off more quickly in African Americans,” said study coinvestigator Gregg J. Silverman, MD, a professor at New York University.

He said that, although the study was more observational in design, “over time when people come back to the clinic, it gives you an idea of whether the agent is still working in their bodies.”

Overall, “our findings raise the question of whether the same therapy dose may be equally effective for all people,” coinvestigator Ilya Kister, MD, also from NYU, added in a press release.

Dr. Kister noted that this could have implications for the way Black patients with autoimmune diseases are treated in the future.

The findings were released ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology.
 

More severe disease in Black patients

Anti-CD20 infusion therapy, or B-cell depletion therapy, is commonly used to treat autoimmune diseases, including MS and NMOSD. “While previous research has shown that this type of infusion therapy is effective for people with these diseases, we also know that Black people tend to have more severe courses of MS,” Dr. Kister said.

Dr. Ilya Kister

“We wanted to compare how quickly the B cells came back in Black people and White people after treatment,” he added.

Dr. Silverman noted that he has been “studying this agent in autoimmune disease for many years. And from all the different studies, I don’t think we had the right population to ask this question. Demographics were just reviewed as they were.”

The current study included 168 participants (mean age, 44 years; 71% women) who had a diagnosis of MS (n = 134) or NMOSD (n = 32) or who were considered to have MS or NMOSD (n = 2). In addition, 36% of the participants self-identified as Black or African American, 36% self-identified as White, and 28% self-identified as another race.

Flow cytometry results were available for all patients after undergoing anti-CD20 infusions at the NYU MS Care Center. Cluster analyses were conducted on the following B-cell subsets: CD19, CD20, IgD, and CD27. “B-cell repopulation was defined as any detectable number of CD19+ cells on flow cytometry,” the investigators reported.
 

Clinical implications?

Results showed that 29.8% of the full study group showed B-cell repopulation a mean of 6.8 months after infusion. In those with B-cell repopulation, 80.3% had IgD+/CD27– subsets, 11.6% had IgD–/CD27+, 6.2% had IgD–/CD27–, and 1.8% had IgD+/CD27+. These B-cell subset ratios did not differ significantly between the Black and White participants.

Interestingly, no patients showed B-cell repopulation before 4 months after infusion. From 4 to 6 months after infusion, there were no significant differences between the Black and White participants in terms of frequency of B-cell repopulation (20.8% vs. 17.9%, respectively; P = .79).

However, repopulation was significantly more frequent in the Black patients 6-12 months after infusion (76.2% vs. 33.3%; P = .02).

Overall, the findings “may have implications for clinical management of MS/NMOSD” in Black individuals, the investigators wrote.

“I was impressed by the differences we saw in responses of patients that were self-declaring as African Americans versus those who were Whites,” Dr. Silverman said. However, “as we say in science: it gives us an answer but it raises even more questions, which may well be important for helping us understand how the agent works and how the disease affects different people.”

Still, Dr. Silverman noted that the findings give clinicians using the agent “a signal that they should be very vigilant. It was an observation at one center, but we’re asking our colleagues [at other clinics] to think about being more careful as they review data with their patients.”

He added that future multicenter studies will allow these issues to be assessed more comprehensively. “This was a discovery study; it now needs validation; and maybe the next step would be looking into the mechanism.”

Dr. Silverman pointed out that the Food and Drug Administration–approved label for this type of therapy “allows for somewhat more frequent dosing. So that might be indicated if it’s found that it’s wearing off in an individual. Perhaps they should be treated more frequently?”

“At a minimum, this has raised our vigilance – and we’re interested to see what the feedback will be at the [AAN] meeting,” he added.
 

Real-world data

Commenting on the findings, Eric Klawiter, MD, associate professor of neurology at Harvard Medical School and director of the Multiple Sclerosis and NMO unit at Massachusetts General Hospital, both in Boston, noted that an important study factor was the focus on repopulation to identify specific groups “who may be early repopulators” as it relates to disease activity and disability progression in MS.

“I thought this was a nicely designed study that made good use of real-world data in MS and NMOSD,” added Dr. Klawiter, who was not involved with the research. He pointed out that timing was another interesting aspect of the study. “As we typically use these cell-depleting agents on an ‘every-6-month’ basis, the most pertinent time frame surrounds those that repopulate prior to 6 months.”

If the current study would have shown differences between the Black and White participants at that time point, “I think that would have been most pertinent from a clinical standpoint and a greater opportunity for intervention,” Dr. Klawiter said. “But we saw that, before 4 and 6 months, [the difference] wasn’t significant.”

Still, “after 6 months, the study demonstrates that Black people with MS and NMOSD may repopulate faster,” he added.

“The only real change a clinician could make would be to modify the frequency of the dosing. So if we can identify certain characteristics that would lead you to want to evaluate for the need of redosing sooner, I think that would be useful,” he said.

Specific characteristics identified in previous research include body mass index. “If there are also ethnicity factors, that would be an additional demographic factor that a clinician should pay close attention to,” said Dr. Klawiter.

He noted that his current practice is to check flow cytometry and B-cell counts at the time of a patient’s next infusion. “And if I’m seeing that B-cell levels are repleting at that time point, I am already then making adjustments with their next infusion as to the dosing frequency,” he added.

“This [study] may elucidate some of the potential reasons why we see some people replete their B cells faster than others, but I think additional studies are necessary to make that determination,” Dr. Klawiter concluded.

Genentech provided funding for the study. Dr. Silverman reported no relevant financial relationships. Dr. Klawiter reported having received research funds and consulting fees from Genentech.

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

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Black patients with multiple sclerosis (MS) or neuromyelitis optica spectrum disorder (NMOSD) may respond differently to common MS treatment compared to their White peers, new research suggests. In a study of almost 200 patients, Black participants with MS or NMOSD showed significantly more rapid B-cell repopulation 6-12 months after receiving anti-CD20 infusion therapy with rituximab or ocrelizumab (Rituxan, Ocrevus, Genentech) than did White participants.

Dr. Gregg Silverman

“The results showed that this B-cell targeted therapy wore off more quickly in African Americans,” said study coinvestigator Gregg J. Silverman, MD, a professor at New York University.

He said that, although the study was more observational in design, “over time when people come back to the clinic, it gives you an idea of whether the agent is still working in their bodies.”

Overall, “our findings raise the question of whether the same therapy dose may be equally effective for all people,” coinvestigator Ilya Kister, MD, also from NYU, added in a press release.

Dr. Kister noted that this could have implications for the way Black patients with autoimmune diseases are treated in the future.

The findings were released ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology.
 

More severe disease in Black patients

Anti-CD20 infusion therapy, or B-cell depletion therapy, is commonly used to treat autoimmune diseases, including MS and NMOSD. “While previous research has shown that this type of infusion therapy is effective for people with these diseases, we also know that Black people tend to have more severe courses of MS,” Dr. Kister said.

Dr. Ilya Kister

“We wanted to compare how quickly the B cells came back in Black people and White people after treatment,” he added.

Dr. Silverman noted that he has been “studying this agent in autoimmune disease for many years. And from all the different studies, I don’t think we had the right population to ask this question. Demographics were just reviewed as they were.”

The current study included 168 participants (mean age, 44 years; 71% women) who had a diagnosis of MS (n = 134) or NMOSD (n = 32) or who were considered to have MS or NMOSD (n = 2). In addition, 36% of the participants self-identified as Black or African American, 36% self-identified as White, and 28% self-identified as another race.

Flow cytometry results were available for all patients after undergoing anti-CD20 infusions at the NYU MS Care Center. Cluster analyses were conducted on the following B-cell subsets: CD19, CD20, IgD, and CD27. “B-cell repopulation was defined as any detectable number of CD19+ cells on flow cytometry,” the investigators reported.
 

Clinical implications?

Results showed that 29.8% of the full study group showed B-cell repopulation a mean of 6.8 months after infusion. In those with B-cell repopulation, 80.3% had IgD+/CD27– subsets, 11.6% had IgD–/CD27+, 6.2% had IgD–/CD27–, and 1.8% had IgD+/CD27+. These B-cell subset ratios did not differ significantly between the Black and White participants.

Interestingly, no patients showed B-cell repopulation before 4 months after infusion. From 4 to 6 months after infusion, there were no significant differences between the Black and White participants in terms of frequency of B-cell repopulation (20.8% vs. 17.9%, respectively; P = .79).

However, repopulation was significantly more frequent in the Black patients 6-12 months after infusion (76.2% vs. 33.3%; P = .02).

Overall, the findings “may have implications for clinical management of MS/NMOSD” in Black individuals, the investigators wrote.

“I was impressed by the differences we saw in responses of patients that were self-declaring as African Americans versus those who were Whites,” Dr. Silverman said. However, “as we say in science: it gives us an answer but it raises even more questions, which may well be important for helping us understand how the agent works and how the disease affects different people.”

Still, Dr. Silverman noted that the findings give clinicians using the agent “a signal that they should be very vigilant. It was an observation at one center, but we’re asking our colleagues [at other clinics] to think about being more careful as they review data with their patients.”

He added that future multicenter studies will allow these issues to be assessed more comprehensively. “This was a discovery study; it now needs validation; and maybe the next step would be looking into the mechanism.”

Dr. Silverman pointed out that the Food and Drug Administration–approved label for this type of therapy “allows for somewhat more frequent dosing. So that might be indicated if it’s found that it’s wearing off in an individual. Perhaps they should be treated more frequently?”

“At a minimum, this has raised our vigilance – and we’re interested to see what the feedback will be at the [AAN] meeting,” he added.
 

Real-world data

Commenting on the findings, Eric Klawiter, MD, associate professor of neurology at Harvard Medical School and director of the Multiple Sclerosis and NMO unit at Massachusetts General Hospital, both in Boston, noted that an important study factor was the focus on repopulation to identify specific groups “who may be early repopulators” as it relates to disease activity and disability progression in MS.

“I thought this was a nicely designed study that made good use of real-world data in MS and NMOSD,” added Dr. Klawiter, who was not involved with the research. He pointed out that timing was another interesting aspect of the study. “As we typically use these cell-depleting agents on an ‘every-6-month’ basis, the most pertinent time frame surrounds those that repopulate prior to 6 months.”

If the current study would have shown differences between the Black and White participants at that time point, “I think that would have been most pertinent from a clinical standpoint and a greater opportunity for intervention,” Dr. Klawiter said. “But we saw that, before 4 and 6 months, [the difference] wasn’t significant.”

Still, “after 6 months, the study demonstrates that Black people with MS and NMOSD may repopulate faster,” he added.

“The only real change a clinician could make would be to modify the frequency of the dosing. So if we can identify certain characteristics that would lead you to want to evaluate for the need of redosing sooner, I think that would be useful,” he said.

Specific characteristics identified in previous research include body mass index. “If there are also ethnicity factors, that would be an additional demographic factor that a clinician should pay close attention to,” said Dr. Klawiter.

He noted that his current practice is to check flow cytometry and B-cell counts at the time of a patient’s next infusion. “And if I’m seeing that B-cell levels are repleting at that time point, I am already then making adjustments with their next infusion as to the dosing frequency,” he added.

“This [study] may elucidate some of the potential reasons why we see some people replete their B cells faster than others, but I think additional studies are necessary to make that determination,” Dr. Klawiter concluded.

Genentech provided funding for the study. Dr. Silverman reported no relevant financial relationships. Dr. Klawiter reported having received research funds and consulting fees from Genentech.

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

Black patients with multiple sclerosis (MS) or neuromyelitis optica spectrum disorder (NMOSD) may respond differently to common MS treatment compared to their White peers, new research suggests. In a study of almost 200 patients, Black participants with MS or NMOSD showed significantly more rapid B-cell repopulation 6-12 months after receiving anti-CD20 infusion therapy with rituximab or ocrelizumab (Rituxan, Ocrevus, Genentech) than did White participants.

Dr. Gregg Silverman

“The results showed that this B-cell targeted therapy wore off more quickly in African Americans,” said study coinvestigator Gregg J. Silverman, MD, a professor at New York University.

He said that, although the study was more observational in design, “over time when people come back to the clinic, it gives you an idea of whether the agent is still working in their bodies.”

Overall, “our findings raise the question of whether the same therapy dose may be equally effective for all people,” coinvestigator Ilya Kister, MD, also from NYU, added in a press release.

Dr. Kister noted that this could have implications for the way Black patients with autoimmune diseases are treated in the future.

The findings were released ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology.
 

More severe disease in Black patients

Anti-CD20 infusion therapy, or B-cell depletion therapy, is commonly used to treat autoimmune diseases, including MS and NMOSD. “While previous research has shown that this type of infusion therapy is effective for people with these diseases, we also know that Black people tend to have more severe courses of MS,” Dr. Kister said.

Dr. Ilya Kister

“We wanted to compare how quickly the B cells came back in Black people and White people after treatment,” he added.

Dr. Silverman noted that he has been “studying this agent in autoimmune disease for many years. And from all the different studies, I don’t think we had the right population to ask this question. Demographics were just reviewed as they were.”

The current study included 168 participants (mean age, 44 years; 71% women) who had a diagnosis of MS (n = 134) or NMOSD (n = 32) or who were considered to have MS or NMOSD (n = 2). In addition, 36% of the participants self-identified as Black or African American, 36% self-identified as White, and 28% self-identified as another race.

Flow cytometry results were available for all patients after undergoing anti-CD20 infusions at the NYU MS Care Center. Cluster analyses were conducted on the following B-cell subsets: CD19, CD20, IgD, and CD27. “B-cell repopulation was defined as any detectable number of CD19+ cells on flow cytometry,” the investigators reported.
 

Clinical implications?

Results showed that 29.8% of the full study group showed B-cell repopulation a mean of 6.8 months after infusion. In those with B-cell repopulation, 80.3% had IgD+/CD27– subsets, 11.6% had IgD–/CD27+, 6.2% had IgD–/CD27–, and 1.8% had IgD+/CD27+. These B-cell subset ratios did not differ significantly between the Black and White participants.

Interestingly, no patients showed B-cell repopulation before 4 months after infusion. From 4 to 6 months after infusion, there were no significant differences between the Black and White participants in terms of frequency of B-cell repopulation (20.8% vs. 17.9%, respectively; P = .79).

However, repopulation was significantly more frequent in the Black patients 6-12 months after infusion (76.2% vs. 33.3%; P = .02).

Overall, the findings “may have implications for clinical management of MS/NMOSD” in Black individuals, the investigators wrote.

“I was impressed by the differences we saw in responses of patients that were self-declaring as African Americans versus those who were Whites,” Dr. Silverman said. However, “as we say in science: it gives us an answer but it raises even more questions, which may well be important for helping us understand how the agent works and how the disease affects different people.”

Still, Dr. Silverman noted that the findings give clinicians using the agent “a signal that they should be very vigilant. It was an observation at one center, but we’re asking our colleagues [at other clinics] to think about being more careful as they review data with their patients.”

He added that future multicenter studies will allow these issues to be assessed more comprehensively. “This was a discovery study; it now needs validation; and maybe the next step would be looking into the mechanism.”

Dr. Silverman pointed out that the Food and Drug Administration–approved label for this type of therapy “allows for somewhat more frequent dosing. So that might be indicated if it’s found that it’s wearing off in an individual. Perhaps they should be treated more frequently?”

“At a minimum, this has raised our vigilance – and we’re interested to see what the feedback will be at the [AAN] meeting,” he added.
 

Real-world data

Commenting on the findings, Eric Klawiter, MD, associate professor of neurology at Harvard Medical School and director of the Multiple Sclerosis and NMO unit at Massachusetts General Hospital, both in Boston, noted that an important study factor was the focus on repopulation to identify specific groups “who may be early repopulators” as it relates to disease activity and disability progression in MS.

“I thought this was a nicely designed study that made good use of real-world data in MS and NMOSD,” added Dr. Klawiter, who was not involved with the research. He pointed out that timing was another interesting aspect of the study. “As we typically use these cell-depleting agents on an ‘every-6-month’ basis, the most pertinent time frame surrounds those that repopulate prior to 6 months.”

If the current study would have shown differences between the Black and White participants at that time point, “I think that would have been most pertinent from a clinical standpoint and a greater opportunity for intervention,” Dr. Klawiter said. “But we saw that, before 4 and 6 months, [the difference] wasn’t significant.”

Still, “after 6 months, the study demonstrates that Black people with MS and NMOSD may repopulate faster,” he added.

“The only real change a clinician could make would be to modify the frequency of the dosing. So if we can identify certain characteristics that would lead you to want to evaluate for the need of redosing sooner, I think that would be useful,” he said.

Specific characteristics identified in previous research include body mass index. “If there are also ethnicity factors, that would be an additional demographic factor that a clinician should pay close attention to,” said Dr. Klawiter.

He noted that his current practice is to check flow cytometry and B-cell counts at the time of a patient’s next infusion. “And if I’m seeing that B-cell levels are repleting at that time point, I am already then making adjustments with their next infusion as to the dosing frequency,” he added.

“This [study] may elucidate some of the potential reasons why we see some people replete their B cells faster than others, but I think additional studies are necessary to make that determination,” Dr. Klawiter concluded.

Genentech provided funding for the study. Dr. Silverman reported no relevant financial relationships. Dr. Klawiter reported having received research funds and consulting fees from Genentech.

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

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What COVID did to MD income in 2020

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Physician compensation plummeted in the opening weeks of the COVID-19 pandemic in March and April 2020, but earnings had rebounded for many physicians by the end of the year, according to the Medscape Physician Compensation Report 2021: The Recovery Begins.

Almost 18,000 physicians in more than 29 specialties told Medscape about their income, hours worked, greatest challenges, and the unexpected impact of COVID-19 on their compensation.
 

How many physicians avoided massive losses

When the pandemic started around March 2020, “a great many physicians saw reductions in volume at first,” says Robert Pearl, MD, former CEO of the Permanente Medical Group and a professor at Stanford (Calif.) University.

Medscape’s survey report shows that a staggering 44% saw a 1%-25% reduction in patient volume, and 9% saw a 26%-50% decline. “That is indeed breathtaking,” Dr. Pearl says.

Several key factors saved many practices from hemorrhaging money, says Michael Belkin, JD, divisional vice president at Merritt Hawkins and Associates in Dallas. “Many physicians used the federal Paycheck Protection Program [PPP] to help keep themselves afloat,” he says. “A large percentage reduced their staff, which reduced their expenses, and many got some of their volume back by transitioning to telemedicine.”

In a 2020 survey for the Physicians Foundation, conducted by Merritt Hawkins, 48% of physicians said their practice had received PPP support, and most of those said the support was enough to allow them to stay open without reducing staff. Only 6% of practices that received PPP support did not stay open.
 

Telemedicine helped many practices

Early in the pandemic, Medicare reimbursements for telemedicine were equal with those for face-to-face visits. “Since telemedicine takes a third less time than an inpatient visit, doctors could see more patients,” Dr. Pearl says.

The switch was almost instantaneous in some practices. Within 3 days, a 200-provider multispecialty practice in Wilmington, N.C., went from not using telehealth to its being used by all physicians, the Medical Group Management Association reported. By late April, the practice was already back up to about 70% of normal overall production.

However, telemedicine could not help every specialty equally. “Generally, allergists can’t do their allergy testing virtually, and patients with mild problems probably put off visits,” Dr. Pearl says. Allergists experienced a large percentage decline in compensation, according to Medscape’s survey. For some, income fell from $301,000 the prior year to $274,000 this year.
 

Primary care struggled

Primary care physicians posted lower compensation than they did the prior year, but most rebounded to some degree. A study released in June 2020 projected that, even with telemedicine, primary care physicians would lose an average of $67,774 for the year.

However, Medscape’s survey found that internists’ average compensation declined from $251,000 in the prior year to $248,000, and average family physicians’ compensation actually rose from $234,000.

Pediatricians had a harder slog. Their average compensation sank from $232,000 to $221,000, according to the report. Even with telemedicine, parents of young children were not contacting the doctor. In May 2020, visits by children aged 3-5 years were down by 56%.
 

 

 

Many proceduralists recovered

Procedure-oriented specialties were particularly hard-hit at first, because many hospitals and some states banned all elective surgeries at the beginning of the pandemic.

“In March and April, ophthalmology practices were virtually at a standstill,” says John B. Pinto, an ophthalmology practice management consultant in San Diego. “But by the fourth quarter, operations were back to normal. Practices were fully open, and patients were coming back in.”

Medscape’s survey shows that, by year’s end, compensation was about the same as the year before for orthopedic surgeons ($511,000 in both the 2020 and 2021 reports); cardiologists actually did better ($438,000 in our 2020 report and $459,000 in 2021); and ophthalmologists’ compensation was about the same ($378,000 in our prior report and $379,000 in 2021).

Some other proceduralists, however, did not do as well. Otolaryngologists’ compensation fell to $417,000, the second-biggest percentage drop. “This may be because otolaryngologists’ chief procedures are tonsillectomies, sinus surgery, and nasal surgery, which can be put off,” Dr. Pearl says.

Anesthesiologists, who depend on surgical volume, also did not earn as much in 2020. Their compensation declined from $398,000 in our 2020 report to $378,000 in Medscape’s 2021 report.

“Not only has 70% of our revenue disappeared, but our physicians are still working every day,” an independent anesthesiology practice in Alabama told the MGMA early in the pandemic.
 

Plastic surgeons now the top earners

The biggest increase in compensation by far was made by plastic surgeons, whose income rose 9.8% over the year before, to $526,000. This put them at the top of the list

Dr. Pearl adds that plastic surgeons can perform their procedures in their offices, rather than in a hospital, where elective surgeries were often canceled.

Mr. Belkin says specialties other than plastic surgery had been offering more boutique cosmetic care even before the pandemic. In 2020, nonsurgical cosmetic procedures such as neurotoxin therapy, dermal filler procedures, chemical peels, and hair removal earned $3.1 billion in revenue, according to a survey by the Aesthetic Society.
 

Other specialties that earned more even during COVID

In Medscape’s survey, several specialties actually earned more during the pandemic than in 2019. Some specialties, such as critical care and public health, were integral in managing COVID patients and the pandemic.

However, some specialties involved in COVID care did not see an increase. Compensation for infectious disease specialists (at $245,000) and emergency medicine specialists (at $354,000) remained basically unchanged from the prior year, and for pulmonologists, it was slightly down.

Emergency departments reported decreases in volume of 40% or more early in the pandemic, according to the American College of Emergency Physicians. It was reported that patients were avoiding EDs for fear of contracting COVID, and car accidents were down because people ventured out less.

In this year’s report, psychiatrists saw a modest rise in compensation, to $275,000. “There has been an increase in mental health visits in the pandemic,” Dr. Pearl says. In 2020, about 4 in 10 adults in the United States reported symptoms of anxiety or depressive disorder, up from 1 in 10 adults the prior year. In addition, psychiatrists were third on the list of Merritt Hawkins’ most requested recruiting engagements.

Oncologists saw a rise in compensation, from $377,000 to $403,000. “Volume likely did not fall because cancer patients would go through with their chemotherapy in spite of the pandemic,” Dr. Pearl says. “The increase in income might have to do with the usual inflation in the cost of chemotherapy drugs.” Dr. Pinto saw the same trend for retinal surgeons, whose care also cannot be delayed.

Medscape’s survey also reports increases in compensation for rheumatologists, endocrinologists, and neurologists, but it reports small declines among dermatologists, radiologists, and gastroenterologists.
 

 

 

Gender-based pay gap remains in place

The gender-based pay gap in this year’s report is similar to that seen in Medscape’s report for the prior year. Men earned 27% more than women in 2021, compared with 25% more the year before. Some physicians commented that more women physicians maintained flexible or shorter work schedules to help with children who could not go into school.

“Having to be a full-time physician, full-time mom, and full-time teacher during our surge was unbelievable,” a primary care pediatrician in group practice and mother of two reported in November. “I felt pulled in all directions and didn’t do anything well.”

In addition, “men dominate some specialties that seem to have seen a smaller drop in volume in the pandemic, such as emergency medicine, infectious disease, pulmonology, and oncology,” says Halee Fischer-Wright, MD, CEO of MGMA.
 

Employed physicians shared their employers’ pain

Employed physicians, who typically work at hospitals, shared the financial pains of their institutions, particularly in the early stages of the pandemic. In April, hospital admissions were 34.1% below prepandemic levels, according to a study published in Health Affairs. That figure had risen by June, but it was still 8.3% below prepandemic volume.

By the end of the year, many hospitals and hospital systems were in the black, thanks in large part to generous federal subsidies, but actual operations still lost money for the year. Altogether, 42% of them posted an operational loss in 2020, up from the 23% in 2019, according to a survey by Moody’s Investors Service.

Medscape’s report shows that many employed physicians lost pay in 2020, and for many, pay had not returned to pre-COVID levels. Only 28% of primary care physicians and 32% of specialists who lost pay have seen it restored, according to the report. In addition, 15% of surveyed physicians did not receive an annual raise.

Many employed doctors are paid on the basis of relative value units (RVUs), which is a measure of the value of their work. In many cases, there was not enough work to reach RVU thresholds. Would hospitals and other employers lower RVU targets to meet the problem? “I haven’t seen our clients make concessions to providers along those lines,” Mr. Belkin says.
 

Physicians had to work longer hours

The Medscape report also found that in 2020, physicians saw fewer patients because each visit took longer.

“With the threat of COVID, in-person visits take more time than before,” Mr. Belkin says. “Physicians and staff have to prepare the exam room after each visit, and doctors must spend more time answering patients’ questions about COVID.”

“The new protocols to keep everyone safe add time between patients, and physicians have to answer patients’ questions about the pandemic and vaccines,” Dr. Fischer-Wright says. “You might see a 20% increase in time spent just on these non–revenue-generating COVID activities.”
 

Physicians still like their specialty

Although 2020 was a challenging year for physicians, the percentage of those who were satisfied with their specialty choice generally did not slip from the year before. It actually rose for several specialties – most notably, rheumatology, pulmonology, physical medicine and rehabilitation, and nephrology.

One specialty saw a decline in satisfaction with their specialty choice, and that was public health and preventive medicine, which plummeted 16 percentage points to 67% – putting it at the bottom of the list.

Even before the pandemic, many public health departments were chronically underfunded. This problem was possibly exacerbated by the pressures to keep up with COVID reporting and testing responsibilities.
 

Conclusion

Although 2020 was a wild ride for many physicians, many came out of it with only minor reductions in overall compensation, and some saw increases. Still, some specialties and many individuals experienced terrible financial stress and had to make changes in their lives and their spending in order to stay afloat.

“The biggest inhibitor to getting back to normal had to do with doctors who did not want to return because they did not want to risk getting COVID,” Dr. Pinto reports. But he notes that by February 2021 most doctors were completely vaccinated and could feel safe again.

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

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Physician compensation plummeted in the opening weeks of the COVID-19 pandemic in March and April 2020, but earnings had rebounded for many physicians by the end of the year, according to the Medscape Physician Compensation Report 2021: The Recovery Begins.

Almost 18,000 physicians in more than 29 specialties told Medscape about their income, hours worked, greatest challenges, and the unexpected impact of COVID-19 on their compensation.
 

How many physicians avoided massive losses

When the pandemic started around March 2020, “a great many physicians saw reductions in volume at first,” says Robert Pearl, MD, former CEO of the Permanente Medical Group and a professor at Stanford (Calif.) University.

Medscape’s survey report shows that a staggering 44% saw a 1%-25% reduction in patient volume, and 9% saw a 26%-50% decline. “That is indeed breathtaking,” Dr. Pearl says.

Several key factors saved many practices from hemorrhaging money, says Michael Belkin, JD, divisional vice president at Merritt Hawkins and Associates in Dallas. “Many physicians used the federal Paycheck Protection Program [PPP] to help keep themselves afloat,” he says. “A large percentage reduced their staff, which reduced their expenses, and many got some of their volume back by transitioning to telemedicine.”

In a 2020 survey for the Physicians Foundation, conducted by Merritt Hawkins, 48% of physicians said their practice had received PPP support, and most of those said the support was enough to allow them to stay open without reducing staff. Only 6% of practices that received PPP support did not stay open.
 

Telemedicine helped many practices

Early in the pandemic, Medicare reimbursements for telemedicine were equal with those for face-to-face visits. “Since telemedicine takes a third less time than an inpatient visit, doctors could see more patients,” Dr. Pearl says.

The switch was almost instantaneous in some practices. Within 3 days, a 200-provider multispecialty practice in Wilmington, N.C., went from not using telehealth to its being used by all physicians, the Medical Group Management Association reported. By late April, the practice was already back up to about 70% of normal overall production.

However, telemedicine could not help every specialty equally. “Generally, allergists can’t do their allergy testing virtually, and patients with mild problems probably put off visits,” Dr. Pearl says. Allergists experienced a large percentage decline in compensation, according to Medscape’s survey. For some, income fell from $301,000 the prior year to $274,000 this year.
 

Primary care struggled

Primary care physicians posted lower compensation than they did the prior year, but most rebounded to some degree. A study released in June 2020 projected that, even with telemedicine, primary care physicians would lose an average of $67,774 for the year.

However, Medscape’s survey found that internists’ average compensation declined from $251,000 in the prior year to $248,000, and average family physicians’ compensation actually rose from $234,000.

Pediatricians had a harder slog. Their average compensation sank from $232,000 to $221,000, according to the report. Even with telemedicine, parents of young children were not contacting the doctor. In May 2020, visits by children aged 3-5 years were down by 56%.
 

 

 

Many proceduralists recovered

Procedure-oriented specialties were particularly hard-hit at first, because many hospitals and some states banned all elective surgeries at the beginning of the pandemic.

“In March and April, ophthalmology practices were virtually at a standstill,” says John B. Pinto, an ophthalmology practice management consultant in San Diego. “But by the fourth quarter, operations were back to normal. Practices were fully open, and patients were coming back in.”

Medscape’s survey shows that, by year’s end, compensation was about the same as the year before for orthopedic surgeons ($511,000 in both the 2020 and 2021 reports); cardiologists actually did better ($438,000 in our 2020 report and $459,000 in 2021); and ophthalmologists’ compensation was about the same ($378,000 in our prior report and $379,000 in 2021).

Some other proceduralists, however, did not do as well. Otolaryngologists’ compensation fell to $417,000, the second-biggest percentage drop. “This may be because otolaryngologists’ chief procedures are tonsillectomies, sinus surgery, and nasal surgery, which can be put off,” Dr. Pearl says.

Anesthesiologists, who depend on surgical volume, also did not earn as much in 2020. Their compensation declined from $398,000 in our 2020 report to $378,000 in Medscape’s 2021 report.

“Not only has 70% of our revenue disappeared, but our physicians are still working every day,” an independent anesthesiology practice in Alabama told the MGMA early in the pandemic.
 

Plastic surgeons now the top earners

The biggest increase in compensation by far was made by plastic surgeons, whose income rose 9.8% over the year before, to $526,000. This put them at the top of the list

Dr. Pearl adds that plastic surgeons can perform their procedures in their offices, rather than in a hospital, where elective surgeries were often canceled.

Mr. Belkin says specialties other than plastic surgery had been offering more boutique cosmetic care even before the pandemic. In 2020, nonsurgical cosmetic procedures such as neurotoxin therapy, dermal filler procedures, chemical peels, and hair removal earned $3.1 billion in revenue, according to a survey by the Aesthetic Society.
 

Other specialties that earned more even during COVID

In Medscape’s survey, several specialties actually earned more during the pandemic than in 2019. Some specialties, such as critical care and public health, were integral in managing COVID patients and the pandemic.

However, some specialties involved in COVID care did not see an increase. Compensation for infectious disease specialists (at $245,000) and emergency medicine specialists (at $354,000) remained basically unchanged from the prior year, and for pulmonologists, it was slightly down.

Emergency departments reported decreases in volume of 40% or more early in the pandemic, according to the American College of Emergency Physicians. It was reported that patients were avoiding EDs for fear of contracting COVID, and car accidents were down because people ventured out less.

In this year’s report, psychiatrists saw a modest rise in compensation, to $275,000. “There has been an increase in mental health visits in the pandemic,” Dr. Pearl says. In 2020, about 4 in 10 adults in the United States reported symptoms of anxiety or depressive disorder, up from 1 in 10 adults the prior year. In addition, psychiatrists were third on the list of Merritt Hawkins’ most requested recruiting engagements.

Oncologists saw a rise in compensation, from $377,000 to $403,000. “Volume likely did not fall because cancer patients would go through with their chemotherapy in spite of the pandemic,” Dr. Pearl says. “The increase in income might have to do with the usual inflation in the cost of chemotherapy drugs.” Dr. Pinto saw the same trend for retinal surgeons, whose care also cannot be delayed.

Medscape’s survey also reports increases in compensation for rheumatologists, endocrinologists, and neurologists, but it reports small declines among dermatologists, radiologists, and gastroenterologists.
 

 

 

Gender-based pay gap remains in place

The gender-based pay gap in this year’s report is similar to that seen in Medscape’s report for the prior year. Men earned 27% more than women in 2021, compared with 25% more the year before. Some physicians commented that more women physicians maintained flexible or shorter work schedules to help with children who could not go into school.

“Having to be a full-time physician, full-time mom, and full-time teacher during our surge was unbelievable,” a primary care pediatrician in group practice and mother of two reported in November. “I felt pulled in all directions and didn’t do anything well.”

In addition, “men dominate some specialties that seem to have seen a smaller drop in volume in the pandemic, such as emergency medicine, infectious disease, pulmonology, and oncology,” says Halee Fischer-Wright, MD, CEO of MGMA.
 

Employed physicians shared their employers’ pain

Employed physicians, who typically work at hospitals, shared the financial pains of their institutions, particularly in the early stages of the pandemic. In April, hospital admissions were 34.1% below prepandemic levels, according to a study published in Health Affairs. That figure had risen by June, but it was still 8.3% below prepandemic volume.

By the end of the year, many hospitals and hospital systems were in the black, thanks in large part to generous federal subsidies, but actual operations still lost money for the year. Altogether, 42% of them posted an operational loss in 2020, up from the 23% in 2019, according to a survey by Moody’s Investors Service.

Medscape’s report shows that many employed physicians lost pay in 2020, and for many, pay had not returned to pre-COVID levels. Only 28% of primary care physicians and 32% of specialists who lost pay have seen it restored, according to the report. In addition, 15% of surveyed physicians did not receive an annual raise.

Many employed doctors are paid on the basis of relative value units (RVUs), which is a measure of the value of their work. In many cases, there was not enough work to reach RVU thresholds. Would hospitals and other employers lower RVU targets to meet the problem? “I haven’t seen our clients make concessions to providers along those lines,” Mr. Belkin says.
 

Physicians had to work longer hours

The Medscape report also found that in 2020, physicians saw fewer patients because each visit took longer.

“With the threat of COVID, in-person visits take more time than before,” Mr. Belkin says. “Physicians and staff have to prepare the exam room after each visit, and doctors must spend more time answering patients’ questions about COVID.”

“The new protocols to keep everyone safe add time between patients, and physicians have to answer patients’ questions about the pandemic and vaccines,” Dr. Fischer-Wright says. “You might see a 20% increase in time spent just on these non–revenue-generating COVID activities.”
 

Physicians still like their specialty

Although 2020 was a challenging year for physicians, the percentage of those who were satisfied with their specialty choice generally did not slip from the year before. It actually rose for several specialties – most notably, rheumatology, pulmonology, physical medicine and rehabilitation, and nephrology.

One specialty saw a decline in satisfaction with their specialty choice, and that was public health and preventive medicine, which plummeted 16 percentage points to 67% – putting it at the bottom of the list.

Even before the pandemic, many public health departments were chronically underfunded. This problem was possibly exacerbated by the pressures to keep up with COVID reporting and testing responsibilities.
 

Conclusion

Although 2020 was a wild ride for many physicians, many came out of it with only minor reductions in overall compensation, and some saw increases. Still, some specialties and many individuals experienced terrible financial stress and had to make changes in their lives and their spending in order to stay afloat.

“The biggest inhibitor to getting back to normal had to do with doctors who did not want to return because they did not want to risk getting COVID,” Dr. Pinto reports. But he notes that by February 2021 most doctors were completely vaccinated and could feel safe again.

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

 

Physician compensation plummeted in the opening weeks of the COVID-19 pandemic in March and April 2020, but earnings had rebounded for many physicians by the end of the year, according to the Medscape Physician Compensation Report 2021: The Recovery Begins.

Almost 18,000 physicians in more than 29 specialties told Medscape about their income, hours worked, greatest challenges, and the unexpected impact of COVID-19 on their compensation.
 

How many physicians avoided massive losses

When the pandemic started around March 2020, “a great many physicians saw reductions in volume at first,” says Robert Pearl, MD, former CEO of the Permanente Medical Group and a professor at Stanford (Calif.) University.

Medscape’s survey report shows that a staggering 44% saw a 1%-25% reduction in patient volume, and 9% saw a 26%-50% decline. “That is indeed breathtaking,” Dr. Pearl says.

Several key factors saved many practices from hemorrhaging money, says Michael Belkin, JD, divisional vice president at Merritt Hawkins and Associates in Dallas. “Many physicians used the federal Paycheck Protection Program [PPP] to help keep themselves afloat,” he says. “A large percentage reduced their staff, which reduced their expenses, and many got some of their volume back by transitioning to telemedicine.”

In a 2020 survey for the Physicians Foundation, conducted by Merritt Hawkins, 48% of physicians said their practice had received PPP support, and most of those said the support was enough to allow them to stay open without reducing staff. Only 6% of practices that received PPP support did not stay open.
 

Telemedicine helped many practices

Early in the pandemic, Medicare reimbursements for telemedicine were equal with those for face-to-face visits. “Since telemedicine takes a third less time than an inpatient visit, doctors could see more patients,” Dr. Pearl says.

The switch was almost instantaneous in some practices. Within 3 days, a 200-provider multispecialty practice in Wilmington, N.C., went from not using telehealth to its being used by all physicians, the Medical Group Management Association reported. By late April, the practice was already back up to about 70% of normal overall production.

However, telemedicine could not help every specialty equally. “Generally, allergists can’t do their allergy testing virtually, and patients with mild problems probably put off visits,” Dr. Pearl says. Allergists experienced a large percentage decline in compensation, according to Medscape’s survey. For some, income fell from $301,000 the prior year to $274,000 this year.
 

Primary care struggled

Primary care physicians posted lower compensation than they did the prior year, but most rebounded to some degree. A study released in June 2020 projected that, even with telemedicine, primary care physicians would lose an average of $67,774 for the year.

However, Medscape’s survey found that internists’ average compensation declined from $251,000 in the prior year to $248,000, and average family physicians’ compensation actually rose from $234,000.

Pediatricians had a harder slog. Their average compensation sank from $232,000 to $221,000, according to the report. Even with telemedicine, parents of young children were not contacting the doctor. In May 2020, visits by children aged 3-5 years were down by 56%.
 

 

 

Many proceduralists recovered

Procedure-oriented specialties were particularly hard-hit at first, because many hospitals and some states banned all elective surgeries at the beginning of the pandemic.

“In March and April, ophthalmology practices were virtually at a standstill,” says John B. Pinto, an ophthalmology practice management consultant in San Diego. “But by the fourth quarter, operations were back to normal. Practices were fully open, and patients were coming back in.”

Medscape’s survey shows that, by year’s end, compensation was about the same as the year before for orthopedic surgeons ($511,000 in both the 2020 and 2021 reports); cardiologists actually did better ($438,000 in our 2020 report and $459,000 in 2021); and ophthalmologists’ compensation was about the same ($378,000 in our prior report and $379,000 in 2021).

Some other proceduralists, however, did not do as well. Otolaryngologists’ compensation fell to $417,000, the second-biggest percentage drop. “This may be because otolaryngologists’ chief procedures are tonsillectomies, sinus surgery, and nasal surgery, which can be put off,” Dr. Pearl says.

Anesthesiologists, who depend on surgical volume, also did not earn as much in 2020. Their compensation declined from $398,000 in our 2020 report to $378,000 in Medscape’s 2021 report.

“Not only has 70% of our revenue disappeared, but our physicians are still working every day,” an independent anesthesiology practice in Alabama told the MGMA early in the pandemic.
 

Plastic surgeons now the top earners

The biggest increase in compensation by far was made by plastic surgeons, whose income rose 9.8% over the year before, to $526,000. This put them at the top of the list

Dr. Pearl adds that plastic surgeons can perform their procedures in their offices, rather than in a hospital, where elective surgeries were often canceled.

Mr. Belkin says specialties other than plastic surgery had been offering more boutique cosmetic care even before the pandemic. In 2020, nonsurgical cosmetic procedures such as neurotoxin therapy, dermal filler procedures, chemical peels, and hair removal earned $3.1 billion in revenue, according to a survey by the Aesthetic Society.
 

Other specialties that earned more even during COVID

In Medscape’s survey, several specialties actually earned more during the pandemic than in 2019. Some specialties, such as critical care and public health, were integral in managing COVID patients and the pandemic.

However, some specialties involved in COVID care did not see an increase. Compensation for infectious disease specialists (at $245,000) and emergency medicine specialists (at $354,000) remained basically unchanged from the prior year, and for pulmonologists, it was slightly down.

Emergency departments reported decreases in volume of 40% or more early in the pandemic, according to the American College of Emergency Physicians. It was reported that patients were avoiding EDs for fear of contracting COVID, and car accidents were down because people ventured out less.

In this year’s report, psychiatrists saw a modest rise in compensation, to $275,000. “There has been an increase in mental health visits in the pandemic,” Dr. Pearl says. In 2020, about 4 in 10 adults in the United States reported symptoms of anxiety or depressive disorder, up from 1 in 10 adults the prior year. In addition, psychiatrists were third on the list of Merritt Hawkins’ most requested recruiting engagements.

Oncologists saw a rise in compensation, from $377,000 to $403,000. “Volume likely did not fall because cancer patients would go through with their chemotherapy in spite of the pandemic,” Dr. Pearl says. “The increase in income might have to do with the usual inflation in the cost of chemotherapy drugs.” Dr. Pinto saw the same trend for retinal surgeons, whose care also cannot be delayed.

Medscape’s survey also reports increases in compensation for rheumatologists, endocrinologists, and neurologists, but it reports small declines among dermatologists, radiologists, and gastroenterologists.
 

 

 

Gender-based pay gap remains in place

The gender-based pay gap in this year’s report is similar to that seen in Medscape’s report for the prior year. Men earned 27% more than women in 2021, compared with 25% more the year before. Some physicians commented that more women physicians maintained flexible or shorter work schedules to help with children who could not go into school.

“Having to be a full-time physician, full-time mom, and full-time teacher during our surge was unbelievable,” a primary care pediatrician in group practice and mother of two reported in November. “I felt pulled in all directions and didn’t do anything well.”

In addition, “men dominate some specialties that seem to have seen a smaller drop in volume in the pandemic, such as emergency medicine, infectious disease, pulmonology, and oncology,” says Halee Fischer-Wright, MD, CEO of MGMA.
 

Employed physicians shared their employers’ pain

Employed physicians, who typically work at hospitals, shared the financial pains of their institutions, particularly in the early stages of the pandemic. In April, hospital admissions were 34.1% below prepandemic levels, according to a study published in Health Affairs. That figure had risen by June, but it was still 8.3% below prepandemic volume.

By the end of the year, many hospitals and hospital systems were in the black, thanks in large part to generous federal subsidies, but actual operations still lost money for the year. Altogether, 42% of them posted an operational loss in 2020, up from the 23% in 2019, according to a survey by Moody’s Investors Service.

Medscape’s report shows that many employed physicians lost pay in 2020, and for many, pay had not returned to pre-COVID levels. Only 28% of primary care physicians and 32% of specialists who lost pay have seen it restored, according to the report. In addition, 15% of surveyed physicians did not receive an annual raise.

Many employed doctors are paid on the basis of relative value units (RVUs), which is a measure of the value of their work. In many cases, there was not enough work to reach RVU thresholds. Would hospitals and other employers lower RVU targets to meet the problem? “I haven’t seen our clients make concessions to providers along those lines,” Mr. Belkin says.
 

Physicians had to work longer hours

The Medscape report also found that in 2020, physicians saw fewer patients because each visit took longer.

“With the threat of COVID, in-person visits take more time than before,” Mr. Belkin says. “Physicians and staff have to prepare the exam room after each visit, and doctors must spend more time answering patients’ questions about COVID.”

“The new protocols to keep everyone safe add time between patients, and physicians have to answer patients’ questions about the pandemic and vaccines,” Dr. Fischer-Wright says. “You might see a 20% increase in time spent just on these non–revenue-generating COVID activities.”
 

Physicians still like their specialty

Although 2020 was a challenging year for physicians, the percentage of those who were satisfied with their specialty choice generally did not slip from the year before. It actually rose for several specialties – most notably, rheumatology, pulmonology, physical medicine and rehabilitation, and nephrology.

One specialty saw a decline in satisfaction with their specialty choice, and that was public health and preventive medicine, which plummeted 16 percentage points to 67% – putting it at the bottom of the list.

Even before the pandemic, many public health departments were chronically underfunded. This problem was possibly exacerbated by the pressures to keep up with COVID reporting and testing responsibilities.
 

Conclusion

Although 2020 was a wild ride for many physicians, many came out of it with only minor reductions in overall compensation, and some saw increases. Still, some specialties and many individuals experienced terrible financial stress and had to make changes in their lives and their spending in order to stay afloat.

“The biggest inhibitor to getting back to normal had to do with doctors who did not want to return because they did not want to risk getting COVID,” Dr. Pinto reports. But he notes that by February 2021 most doctors were completely vaccinated and could feel safe again.

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

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Migraineurs not taking advantage of an ‘effective prophylactic’

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The majority of patients with migraine do not get the recommended amount of weekly exercise, but those who do gain benefits that extend to fewer migraine days and reduced rates of triggers including stress, depression, and sleep problems, new research shows.

“This study adds to an ever-growing body of research that points to exercise as an effective way to promote general well-being and reduce monthly migraine days,” said study investigator Mason Dyess, DO, from the University of Washington, Seattle. “This study also highlights that exercise is an underutilized resource in migraine sufferers.”

The findings were released ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology..
 

An accessible prophylactic

Dr. Dyess said that the COVID-19 pandemic prompted him and his colleagues to investigate how many patients with migraine in their headache clinic were utilizing “one of the most accessible prevention tools for migraine – exercise.”

“The pandemic has restricted physical and financial access to care for patients in our community and across the country, so understanding how exercise is being used by our patients and its effect on monthly migraine days has never been more important,” Dr. Dyess said.

The study involved 4,647 people diagnosed with migraine. About three-fourths had chronic migraine (at least 15 migraine days a month) and about one-quarter had episodic migraine (up to 14 monthly migraine days).

The patients provided information via a questionnaire about their migraine characteristics, sleep, depression, stress, anxiety, and the amount of moderate to vigorous exercise they got each week.

Only 27% of patients reported getting at least 150 minutes of moderate to vigorous exercise each week, the minimum amount recommended by the World Health Organization.

Patients with migraine who did not achieve the minimum 2.5 hours of moderate to vigorous exercise recommended per week had increased rates of depression, anxiety, and sleep problems.
 

A word of caution

Depression was reported by 47% of patients who reported no exercise, compared with 25% of people who reported the recommended amount of weekly exercise.

Anxiety was reported by 39% of people who did not exercise, compared with 28% of those who got the recommended 150-plus minutes of exercise. Sleep problems were reported by 77% of the nonexercisers versus 61% of those who achieved the recommended exercise amount.

Exercise also appeared to reduce the risk for migraine attacks.

Among patients who did not exercise, 48% had high headache frequency (25-plus headache days per month), while only 5% had low headache frequency (0-4 headache days per month).

In contrast, of people who got the recommended 150-plus minutes of exercise per week, 28% had high headache frequency and 10% had low headache frequency.

“Exercise should be part of the discussion while counseling patients with migraines. This is a resource available across the socioeconomic spectrum that is easily integrated into the plan of care for many patients,” said Dr. Dyess. 

However, he cautioned that there is a subgroup of migraine patients for whom moderate to vigorous exercise is simply not tolerable. “In these patients, research points to the promotion of a healthy diet and lifestyle with gentle movement exercises like yoga rather than aggressively pursuing moderate or vigorous exercise regimens,” Dr. Dyess said.
 

 

 

A ‘puzzling’ relationship

Reached for comment, Shaheen Lakhan, MD, PhD, a neurologist in Newton, Mass., and executive director of Global Neuroscience Initiative Foundation, said the interaction of exercise and migraine is “puzzling.”

“First, it is well known that strenuous physical exercise may aggravate or even trigger migraine attacks. These are found even in the migraine diagnostic criteria,” said Dr. Lakhan. “Interestingly, there is a body of evidence that demonstrates a basic level of exercise as prophylactic treatment for migraine.”

Dr. Lakhan said that exercise is “definitely underutilized in clinical practice for migraine for these reasons: Migraineurs have fear avoidance behavior given the strenuous physical exercise as a potential trigger.”

Also weighing in on the study, Noah Rosen, MD, director of Northwell Health’s Headache Center in Great Neck, N.Y., said it’s a “useful reminder of the benefits that can be achieved without medication, but we need more information to give better guidance. I wish this study had given us more information as to what type of exercise was best for people with migraine, whether active group sports, running, swimming, or others.”

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

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The majority of patients with migraine do not get the recommended amount of weekly exercise, but those who do gain benefits that extend to fewer migraine days and reduced rates of triggers including stress, depression, and sleep problems, new research shows.

“This study adds to an ever-growing body of research that points to exercise as an effective way to promote general well-being and reduce monthly migraine days,” said study investigator Mason Dyess, DO, from the University of Washington, Seattle. “This study also highlights that exercise is an underutilized resource in migraine sufferers.”

The findings were released ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology..
 

An accessible prophylactic

Dr. Dyess said that the COVID-19 pandemic prompted him and his colleagues to investigate how many patients with migraine in their headache clinic were utilizing “one of the most accessible prevention tools for migraine – exercise.”

“The pandemic has restricted physical and financial access to care for patients in our community and across the country, so understanding how exercise is being used by our patients and its effect on monthly migraine days has never been more important,” Dr. Dyess said.

The study involved 4,647 people diagnosed with migraine. About three-fourths had chronic migraine (at least 15 migraine days a month) and about one-quarter had episodic migraine (up to 14 monthly migraine days).

The patients provided information via a questionnaire about their migraine characteristics, sleep, depression, stress, anxiety, and the amount of moderate to vigorous exercise they got each week.

Only 27% of patients reported getting at least 150 minutes of moderate to vigorous exercise each week, the minimum amount recommended by the World Health Organization.

Patients with migraine who did not achieve the minimum 2.5 hours of moderate to vigorous exercise recommended per week had increased rates of depression, anxiety, and sleep problems.
 

A word of caution

Depression was reported by 47% of patients who reported no exercise, compared with 25% of people who reported the recommended amount of weekly exercise.

Anxiety was reported by 39% of people who did not exercise, compared with 28% of those who got the recommended 150-plus minutes of exercise. Sleep problems were reported by 77% of the nonexercisers versus 61% of those who achieved the recommended exercise amount.

Exercise also appeared to reduce the risk for migraine attacks.

Among patients who did not exercise, 48% had high headache frequency (25-plus headache days per month), while only 5% had low headache frequency (0-4 headache days per month).

In contrast, of people who got the recommended 150-plus minutes of exercise per week, 28% had high headache frequency and 10% had low headache frequency.

“Exercise should be part of the discussion while counseling patients with migraines. This is a resource available across the socioeconomic spectrum that is easily integrated into the plan of care for many patients,” said Dr. Dyess. 

However, he cautioned that there is a subgroup of migraine patients for whom moderate to vigorous exercise is simply not tolerable. “In these patients, research points to the promotion of a healthy diet and lifestyle with gentle movement exercises like yoga rather than aggressively pursuing moderate or vigorous exercise regimens,” Dr. Dyess said.
 

 

 

A ‘puzzling’ relationship

Reached for comment, Shaheen Lakhan, MD, PhD, a neurologist in Newton, Mass., and executive director of Global Neuroscience Initiative Foundation, said the interaction of exercise and migraine is “puzzling.”

“First, it is well known that strenuous physical exercise may aggravate or even trigger migraine attacks. These are found even in the migraine diagnostic criteria,” said Dr. Lakhan. “Interestingly, there is a body of evidence that demonstrates a basic level of exercise as prophylactic treatment for migraine.”

Dr. Lakhan said that exercise is “definitely underutilized in clinical practice for migraine for these reasons: Migraineurs have fear avoidance behavior given the strenuous physical exercise as a potential trigger.”

Also weighing in on the study, Noah Rosen, MD, director of Northwell Health’s Headache Center in Great Neck, N.Y., said it’s a “useful reminder of the benefits that can be achieved without medication, but we need more information to give better guidance. I wish this study had given us more information as to what type of exercise was best for people with migraine, whether active group sports, running, swimming, or others.”

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

 

The majority of patients with migraine do not get the recommended amount of weekly exercise, but those who do gain benefits that extend to fewer migraine days and reduced rates of triggers including stress, depression, and sleep problems, new research shows.

“This study adds to an ever-growing body of research that points to exercise as an effective way to promote general well-being and reduce monthly migraine days,” said study investigator Mason Dyess, DO, from the University of Washington, Seattle. “This study also highlights that exercise is an underutilized resource in migraine sufferers.”

The findings were released ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology..
 

An accessible prophylactic

Dr. Dyess said that the COVID-19 pandemic prompted him and his colleagues to investigate how many patients with migraine in their headache clinic were utilizing “one of the most accessible prevention tools for migraine – exercise.”

“The pandemic has restricted physical and financial access to care for patients in our community and across the country, so understanding how exercise is being used by our patients and its effect on monthly migraine days has never been more important,” Dr. Dyess said.

The study involved 4,647 people diagnosed with migraine. About three-fourths had chronic migraine (at least 15 migraine days a month) and about one-quarter had episodic migraine (up to 14 monthly migraine days).

The patients provided information via a questionnaire about their migraine characteristics, sleep, depression, stress, anxiety, and the amount of moderate to vigorous exercise they got each week.

Only 27% of patients reported getting at least 150 minutes of moderate to vigorous exercise each week, the minimum amount recommended by the World Health Organization.

Patients with migraine who did not achieve the minimum 2.5 hours of moderate to vigorous exercise recommended per week had increased rates of depression, anxiety, and sleep problems.
 

A word of caution

Depression was reported by 47% of patients who reported no exercise, compared with 25% of people who reported the recommended amount of weekly exercise.

Anxiety was reported by 39% of people who did not exercise, compared with 28% of those who got the recommended 150-plus minutes of exercise. Sleep problems were reported by 77% of the nonexercisers versus 61% of those who achieved the recommended exercise amount.

Exercise also appeared to reduce the risk for migraine attacks.

Among patients who did not exercise, 48% had high headache frequency (25-plus headache days per month), while only 5% had low headache frequency (0-4 headache days per month).

In contrast, of people who got the recommended 150-plus minutes of exercise per week, 28% had high headache frequency and 10% had low headache frequency.

“Exercise should be part of the discussion while counseling patients with migraines. This is a resource available across the socioeconomic spectrum that is easily integrated into the plan of care for many patients,” said Dr. Dyess. 

However, he cautioned that there is a subgroup of migraine patients for whom moderate to vigorous exercise is simply not tolerable. “In these patients, research points to the promotion of a healthy diet and lifestyle with gentle movement exercises like yoga rather than aggressively pursuing moderate or vigorous exercise regimens,” Dr. Dyess said.
 

 

 

A ‘puzzling’ relationship

Reached for comment, Shaheen Lakhan, MD, PhD, a neurologist in Newton, Mass., and executive director of Global Neuroscience Initiative Foundation, said the interaction of exercise and migraine is “puzzling.”

“First, it is well known that strenuous physical exercise may aggravate or even trigger migraine attacks. These are found even in the migraine diagnostic criteria,” said Dr. Lakhan. “Interestingly, there is a body of evidence that demonstrates a basic level of exercise as prophylactic treatment for migraine.”

Dr. Lakhan said that exercise is “definitely underutilized in clinical practice for migraine for these reasons: Migraineurs have fear avoidance behavior given the strenuous physical exercise as a potential trigger.”

Also weighing in on the study, Noah Rosen, MD, director of Northwell Health’s Headache Center in Great Neck, N.Y., said it’s a “useful reminder of the benefits that can be achieved without medication, but we need more information to give better guidance. I wish this study had given us more information as to what type of exercise was best for people with migraine, whether active group sports, running, swimming, or others.”

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

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Watch for abnormal movements in hospitalized COVID-19 patients

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Myoclonus was diagnosed in about half of hospitalized COVID-19 patients who were evaluated for movement disorders, data from 50 cases show.

Abnormal movements often occur as complications from critical illness, and neurologic consultation can determine whether patients have experienced a seizure or stroke. However, restriction of bedside assessment in the wake of the COVID-19 pandemic increases the risk that abnormal movements will be missed, Jeffrey R. Clark and Eric M. Liotta, MD, of Northwestern University, Chicago, and colleagues wrote.

“Given the limited reports of abnormal movements in hospitalized COVID-19 patients and increased recognition of neurologic manifestations of COVID-19, we sought to examine the frequency and etiology of this finding as an indication of neurologic consultation,” they said.

In a study published in the Journal of the Neurological Sciences, the researchers reviewed data from the first 50 consecutive patients with COVID-19 symptoms who were hospitalized at a single center and underwent neurologic consultation between March 17, 2020, and May 18, 2020.

Overall, 11 patients (22.0%) of patients experienced abnormal movement, and all were admitted to the ICU within 7 days of meeting criteria for severe COVID-19. These patients included nine men and two women with an age range of 36-78 years. The most common comorbidities were obesity, hypertension, diabetes, chronic kidney disease, and coronary artery disease.

Myoclonus (generalized and focal) was the most common abnormal movement, and present in 6 of the 11 patients. Three cases were attributed to high-intensity sedation, and three to toxic-metabolic disturbances. In two patients, abnormal movements were attributed to focal seizures in the setting of encephalopathy, with focal facial twitching. An additional two patients experienced tremors; one showed an acute subdural hemorrhage on CT imaging. The second patient showed no sign of stroke or other abnormality on MRI and the tremor improved during the hospital stay. One patient who experienced abnormal high-amplitude nonrhythmic movements of the lower extremities was diagnosed with serotonin syndrome that resolved after discontinuing high-dose fentanyl.

The study findings were limited by several factors, including the small study population and limited availability of MRI, the researchers noted. Assessing severe COVID-19 cases in the ICU setting presents a challenge because of limited patient participation and the potentially confounding effects of sedation and mechanical ventilation.

However, the results highlight the importance of bedside consultation for neurologic evaluation to implement timely, directed treatments, the researchers said.

“A heightened awareness of abnormal eye movements, or subtle facial tremoring, may be the first steps in recognizing potentially dangerous neurologic manifestations,” and clinicians caring for patients with severe COVID-19 should be able to recognize abnormal movements and seek neurologic consultation when indicated, they emphasized.

The study was supported in part by grants to coauthors Nicholas J. Reish, MD, and Dr. Liotta from the National Institutes of Health. The researchers had no financial conflicts to disclose.

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Myoclonus was diagnosed in about half of hospitalized COVID-19 patients who were evaluated for movement disorders, data from 50 cases show.

Abnormal movements often occur as complications from critical illness, and neurologic consultation can determine whether patients have experienced a seizure or stroke. However, restriction of bedside assessment in the wake of the COVID-19 pandemic increases the risk that abnormal movements will be missed, Jeffrey R. Clark and Eric M. Liotta, MD, of Northwestern University, Chicago, and colleagues wrote.

“Given the limited reports of abnormal movements in hospitalized COVID-19 patients and increased recognition of neurologic manifestations of COVID-19, we sought to examine the frequency and etiology of this finding as an indication of neurologic consultation,” they said.

In a study published in the Journal of the Neurological Sciences, the researchers reviewed data from the first 50 consecutive patients with COVID-19 symptoms who were hospitalized at a single center and underwent neurologic consultation between March 17, 2020, and May 18, 2020.

Overall, 11 patients (22.0%) of patients experienced abnormal movement, and all were admitted to the ICU within 7 days of meeting criteria for severe COVID-19. These patients included nine men and two women with an age range of 36-78 years. The most common comorbidities were obesity, hypertension, diabetes, chronic kidney disease, and coronary artery disease.

Myoclonus (generalized and focal) was the most common abnormal movement, and present in 6 of the 11 patients. Three cases were attributed to high-intensity sedation, and three to toxic-metabolic disturbances. In two patients, abnormal movements were attributed to focal seizures in the setting of encephalopathy, with focal facial twitching. An additional two patients experienced tremors; one showed an acute subdural hemorrhage on CT imaging. The second patient showed no sign of stroke or other abnormality on MRI and the tremor improved during the hospital stay. One patient who experienced abnormal high-amplitude nonrhythmic movements of the lower extremities was diagnosed with serotonin syndrome that resolved after discontinuing high-dose fentanyl.

The study findings were limited by several factors, including the small study population and limited availability of MRI, the researchers noted. Assessing severe COVID-19 cases in the ICU setting presents a challenge because of limited patient participation and the potentially confounding effects of sedation and mechanical ventilation.

However, the results highlight the importance of bedside consultation for neurologic evaluation to implement timely, directed treatments, the researchers said.

“A heightened awareness of abnormal eye movements, or subtle facial tremoring, may be the first steps in recognizing potentially dangerous neurologic manifestations,” and clinicians caring for patients with severe COVID-19 should be able to recognize abnormal movements and seek neurologic consultation when indicated, they emphasized.

The study was supported in part by grants to coauthors Nicholas J. Reish, MD, and Dr. Liotta from the National Institutes of Health. The researchers had no financial conflicts to disclose.

 

Myoclonus was diagnosed in about half of hospitalized COVID-19 patients who were evaluated for movement disorders, data from 50 cases show.

Abnormal movements often occur as complications from critical illness, and neurologic consultation can determine whether patients have experienced a seizure or stroke. However, restriction of bedside assessment in the wake of the COVID-19 pandemic increases the risk that abnormal movements will be missed, Jeffrey R. Clark and Eric M. Liotta, MD, of Northwestern University, Chicago, and colleagues wrote.

“Given the limited reports of abnormal movements in hospitalized COVID-19 patients and increased recognition of neurologic manifestations of COVID-19, we sought to examine the frequency and etiology of this finding as an indication of neurologic consultation,” they said.

In a study published in the Journal of the Neurological Sciences, the researchers reviewed data from the first 50 consecutive patients with COVID-19 symptoms who were hospitalized at a single center and underwent neurologic consultation between March 17, 2020, and May 18, 2020.

Overall, 11 patients (22.0%) of patients experienced abnormal movement, and all were admitted to the ICU within 7 days of meeting criteria for severe COVID-19. These patients included nine men and two women with an age range of 36-78 years. The most common comorbidities were obesity, hypertension, diabetes, chronic kidney disease, and coronary artery disease.

Myoclonus (generalized and focal) was the most common abnormal movement, and present in 6 of the 11 patients. Three cases were attributed to high-intensity sedation, and three to toxic-metabolic disturbances. In two patients, abnormal movements were attributed to focal seizures in the setting of encephalopathy, with focal facial twitching. An additional two patients experienced tremors; one showed an acute subdural hemorrhage on CT imaging. The second patient showed no sign of stroke or other abnormality on MRI and the tremor improved during the hospital stay. One patient who experienced abnormal high-amplitude nonrhythmic movements of the lower extremities was diagnosed with serotonin syndrome that resolved after discontinuing high-dose fentanyl.

The study findings were limited by several factors, including the small study population and limited availability of MRI, the researchers noted. Assessing severe COVID-19 cases in the ICU setting presents a challenge because of limited patient participation and the potentially confounding effects of sedation and mechanical ventilation.

However, the results highlight the importance of bedside consultation for neurologic evaluation to implement timely, directed treatments, the researchers said.

“A heightened awareness of abnormal eye movements, or subtle facial tremoring, may be the first steps in recognizing potentially dangerous neurologic manifestations,” and clinicians caring for patients with severe COVID-19 should be able to recognize abnormal movements and seek neurologic consultation when indicated, they emphasized.

The study was supported in part by grants to coauthors Nicholas J. Reish, MD, and Dr. Liotta from the National Institutes of Health. The researchers had no financial conflicts to disclose.

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Cardiologists can perform stroke thrombectomy to fill ‘unmet need’

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Mon, 04/19/2021 - 14:29

Cardiologists experienced in cardiac interventions can competently perform stroke thrombectomy after a short period of training, with outcomes comparable to those achieved by neuroradiology centers, a new study suggests.
 

“Using interventional cardiologists in this way will help address the huge unmet need for stroke thrombectomy that currently exists,” senior author Petr Widimsky, MD, said in an interview.

Although this may be a feasible way forward in Europe, there is strong opposition to such a proposal from U.S. neurointerventionalists.  

The study, published in the April 12 issue of JACC: Cardiovascular Interventions, describes the establishment of a stroke thrombectomy program in University Hospital Kralovske Vinohrady, a large tertiary hospital in Prague, Czech Republic.

The hospital did not have a neurointerventional program until 2012 when a joint program was started involving an experienced team of cardiologists, angiologists, and one interventional radiologist who trained the cardiologists on the thrombectomy procedure.

The current paper reports on the outcomes of the 333 patients with large vessel occlusion stroke treated under this program between October 2012 and December 2019.

The decision to perform catheter-based thrombectomy was made by a neurologist and was based on acute stroke clinical symptoms and CT angiographic findings.

Results show that functional clinical outcomes, assessed via the Modified Rankin Scale (mRS) score at 3 months, did not vary significantly across years 2012 to 2019, with a favorable outcome (mRS 0 to 2) achieved in 47.9% of patients.

Symptomatic intracerebral hemorrhage occurred in 19 patients (5.7%) and embolization in a new vascular territory occurred in 6 patients (1.8%), outcomes similar to those of neuroradiology centers.

The desired clinical results were achieved from the onset of the program, without any signs of a learning curve effect, they reported.

“These findings support the potential role of interventional cardiac cath labs in the treatment of acute stroke in regions where this therapy is not readily available due to the lack of neurointerventionalists,” the authors concluded.

“Our main message is that our results were excellent from the beginning,” Dr. Widimsky said. “When centers prepare properly, they can achieve excellent results from the beginning with cardiologists who are experienced in interventional procedures and who have spent sufficient time learning about the brain.”  

The authors noted that despite thrombectomy being an extremely beneficial treatment for severe stroke, many eligible patients remain untreated, largely because of a lack of neurointerventionalists in many regions worldwide. They estimate that about 15% of all stroke patients are eligible for thrombectomy but only around 2% of stroke patients in Europe actually receive such treatment.

Dr. Widimsky, an interventional cardiologist, first thought of the idea of using cardiologists to perform stroke thrombectomies after a good friend and colleague suffered a severe stroke in 2010.

“This made us realize that our hospital needed to be more active in the stroke field,” he said. “We decided that we needed to start doing stroke interventions.”

But the major problem was the lack of neurointerventionalists.

“There are not enough neurointerventionalists in Europe. Interventional cardiologists can perform thousands of procedures every year whereas a neurointerventionalist will at best perform hundreds a year. It is quicker and simpler to train the cardiologist to do it,” Dr. Widimsky said.  

They hired one neurointerventionalist to lead the program. “He was our tutor, he taught us his skills,” Dr. Widimsky said. “The cath lab is open 24/7, but if we only have one neurointerventionalist we cannot offer a 24/7 service for stroke thrombectomy. But if we merge with cardiology then we can,” he added.

Their hospital is a very busy center for myocardial infarctionpercutaneous coronary intervention, and carotid stenting, he noted. “It is not difficult to make the step from that to stroke thrombectomy. Interventional cardiologists are used to performing carotid and coronary artery stenting. Stroke thrombectomy is a similar technique. The thrombectomy procedure is different from coronary angioplasty but it is not more difficult.  Actually, I think coronary angioplasty can be more difficult.”  

Dr. Widimsky explained that cardiologists need to learn about the brain anatomy and physiology and learn the stroke imaging techniques. “I spent 1 month in the U.S. learning stroke interventions working with simulators,” he said. “I think interventional cardiologists can learn what they need to know in about 6 months. I would recommend they should watch about 50 procedures and perform at least 25 under supervision.”

He said this model is the way forward and hopes it will become routine. Thrombectomy is “tremendously effective” in improving outcomes in severe strokes, with a number needed to treat (NNT) of just 2.6 to prevent long-term disability in one patient, he said, while other procedures can have NNTs of 50 or more.  

“But millions of patients with acute severe stroke are not getting this life-changing treatment,” he added. “We must do everything we can to make this service available to as many patients as possible.”

Dr. Widimsky acknowledges that there has been opposition to this idea from the neurointerventionalist professional bodies but this has lessened recently, at least in Europe. And a program that allows interventionalists with experience in extracranial carotid and vertebral endovascular procedures to “fast-track” technical training has now been proposed.

“There is an enormous unmet need for stroke thrombectomy in Europe, with some countries needing to increase the number of procedures done by 10 or 20 times. These include the U.K., Sweden, Italy, Spain, and Portugal. This cannot be done without cardiology,” Dr. Widimsky said.  
 

 

 

Editorial strongly supportive

An accompanying editorial strongly endorses the idea of using interdisciplinary teams to deliver high standard stroke care.

Marius Hornung, MD, and Horst Sievert, MD, from CardioVascular Center Frankfurt (Germany), point out that many experienced cardiologists are trained in performing carotid artery interventions and are therefore experienced in accessing the supra-aortic arteries.

Ted Bosworth/MDedge News
Dr. Horst Sievert


“To be able to guarantee optimized stroke therapy as soon as possible, disputes over competence among the individual medical societies involved must be ended,” they wrote.

They advocate for the creation of interdisciplinary teams, with diagnostics, patient selection, and follow-up care remaining the core competencies and tasks of neurology; in addition, they call for appropriately trained and experienced physicians – regardless of their specialties – performing acute stroke interventions and endovascular thrombectomy.  

“Such a network must be installed as soon as possible to fulfill the mantra ‘time is brain’ ... and not losing unnecessary time to patient transfer, or continuing to offer only the second-best therapy,” they concluded.
 

Opposition in the United States

Dr. Widimsky explained that this proposal may not be so applicable to the United States, where the need for more clinicians capable of performing stroke thrombectomies does not appear to be as critical, possibly because vascular neurosurgeons as well as neuroradiologists are qualified to undertake these procedures.

In an interview, J. Mocco, MD, director of the cerebrovascular center, department of neurological surgery, at Mount Sinai Health System, New York, confirmed that this was the case.

MDedge News
Dr. J. Mocco


“There is no legitimate data to support the claim that there is a lack of an adequate workforce to provide stroke thrombectomy, at least in the U.S.,” he said, adding that, rather, the primary limitation to patient access is a lack of adequate systems of care. “We should learn from the trauma model, which is strongly evidence based, and provide emergency stroke care in a similarly regionalized manner.”

Dr. Mocco, vice president of the Society of NeuroInterventional Surgery, was not impressed with the current study.

“This paper is a retrospective, single-center, unadjudicated, nonindependent assessor case series and therefore, as the authors acknowledge in the limitations section of their paper, it is invalid to compare these data to the results from high-quality, prospective, core-lab, and independent assessor adjudicated randomized trials,” he said. “The supposition that this trial provides evidence that the reported model should be widely considered lacks scientific rigor.”  

Furthermore, “the interventional cardiology literature is replete with data regarding the importance of technical expertise and content knowledge,” he added. “Why would that community now propose that such expertise and knowledge is not necessary for the brain?”

Dr. Mocco argues that the concept that interventional cardiologists should be fast-tracked to perform stroke interventions because they use similar tools, navigate blood vessels, and are comfortable working in critical situations, does not hold up.

“Liver surgeons and brain surgeons are both familiar with tissue manipulation, are used to operating in critical situations, and use cautery, scissors, and scalpels; but no one would argue that a brain surgeon should be fast-tracked to perform liver surgery, or vice versa.” 

He added: “Stroke patients do not have the luxury of choosing the physician who provides their thrombectomy. We should do everything reasonable to ensure that our systems of care are organized so that these vulnerable patients are treated by physicians who have appropriate knowledge and expertise.” 

This study was supported by the Charles University Research program. The authors and editorialists have disclosed no relevant financial relationships.

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

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Cardiologists experienced in cardiac interventions can competently perform stroke thrombectomy after a short period of training, with outcomes comparable to those achieved by neuroradiology centers, a new study suggests.
 

“Using interventional cardiologists in this way will help address the huge unmet need for stroke thrombectomy that currently exists,” senior author Petr Widimsky, MD, said in an interview.

Although this may be a feasible way forward in Europe, there is strong opposition to such a proposal from U.S. neurointerventionalists.  

The study, published in the April 12 issue of JACC: Cardiovascular Interventions, describes the establishment of a stroke thrombectomy program in University Hospital Kralovske Vinohrady, a large tertiary hospital in Prague, Czech Republic.

The hospital did not have a neurointerventional program until 2012 when a joint program was started involving an experienced team of cardiologists, angiologists, and one interventional radiologist who trained the cardiologists on the thrombectomy procedure.

The current paper reports on the outcomes of the 333 patients with large vessel occlusion stroke treated under this program between October 2012 and December 2019.

The decision to perform catheter-based thrombectomy was made by a neurologist and was based on acute stroke clinical symptoms and CT angiographic findings.

Results show that functional clinical outcomes, assessed via the Modified Rankin Scale (mRS) score at 3 months, did not vary significantly across years 2012 to 2019, with a favorable outcome (mRS 0 to 2) achieved in 47.9% of patients.

Symptomatic intracerebral hemorrhage occurred in 19 patients (5.7%) and embolization in a new vascular territory occurred in 6 patients (1.8%), outcomes similar to those of neuroradiology centers.

The desired clinical results were achieved from the onset of the program, without any signs of a learning curve effect, they reported.

“These findings support the potential role of interventional cardiac cath labs in the treatment of acute stroke in regions where this therapy is not readily available due to the lack of neurointerventionalists,” the authors concluded.

“Our main message is that our results were excellent from the beginning,” Dr. Widimsky said. “When centers prepare properly, they can achieve excellent results from the beginning with cardiologists who are experienced in interventional procedures and who have spent sufficient time learning about the brain.”  

The authors noted that despite thrombectomy being an extremely beneficial treatment for severe stroke, many eligible patients remain untreated, largely because of a lack of neurointerventionalists in many regions worldwide. They estimate that about 15% of all stroke patients are eligible for thrombectomy but only around 2% of stroke patients in Europe actually receive such treatment.

Dr. Widimsky, an interventional cardiologist, first thought of the idea of using cardiologists to perform stroke thrombectomies after a good friend and colleague suffered a severe stroke in 2010.

“This made us realize that our hospital needed to be more active in the stroke field,” he said. “We decided that we needed to start doing stroke interventions.”

But the major problem was the lack of neurointerventionalists.

“There are not enough neurointerventionalists in Europe. Interventional cardiologists can perform thousands of procedures every year whereas a neurointerventionalist will at best perform hundreds a year. It is quicker and simpler to train the cardiologist to do it,” Dr. Widimsky said.  

They hired one neurointerventionalist to lead the program. “He was our tutor, he taught us his skills,” Dr. Widimsky said. “The cath lab is open 24/7, but if we only have one neurointerventionalist we cannot offer a 24/7 service for stroke thrombectomy. But if we merge with cardiology then we can,” he added.

Their hospital is a very busy center for myocardial infarctionpercutaneous coronary intervention, and carotid stenting, he noted. “It is not difficult to make the step from that to stroke thrombectomy. Interventional cardiologists are used to performing carotid and coronary artery stenting. Stroke thrombectomy is a similar technique. The thrombectomy procedure is different from coronary angioplasty but it is not more difficult.  Actually, I think coronary angioplasty can be more difficult.”  

Dr. Widimsky explained that cardiologists need to learn about the brain anatomy and physiology and learn the stroke imaging techniques. “I spent 1 month in the U.S. learning stroke interventions working with simulators,” he said. “I think interventional cardiologists can learn what they need to know in about 6 months. I would recommend they should watch about 50 procedures and perform at least 25 under supervision.”

He said this model is the way forward and hopes it will become routine. Thrombectomy is “tremendously effective” in improving outcomes in severe strokes, with a number needed to treat (NNT) of just 2.6 to prevent long-term disability in one patient, he said, while other procedures can have NNTs of 50 or more.  

“But millions of patients with acute severe stroke are not getting this life-changing treatment,” he added. “We must do everything we can to make this service available to as many patients as possible.”

Dr. Widimsky acknowledges that there has been opposition to this idea from the neurointerventionalist professional bodies but this has lessened recently, at least in Europe. And a program that allows interventionalists with experience in extracranial carotid and vertebral endovascular procedures to “fast-track” technical training has now been proposed.

“There is an enormous unmet need for stroke thrombectomy in Europe, with some countries needing to increase the number of procedures done by 10 or 20 times. These include the U.K., Sweden, Italy, Spain, and Portugal. This cannot be done without cardiology,” Dr. Widimsky said.  
 

 

 

Editorial strongly supportive

An accompanying editorial strongly endorses the idea of using interdisciplinary teams to deliver high standard stroke care.

Marius Hornung, MD, and Horst Sievert, MD, from CardioVascular Center Frankfurt (Germany), point out that many experienced cardiologists are trained in performing carotid artery interventions and are therefore experienced in accessing the supra-aortic arteries.

Ted Bosworth/MDedge News
Dr. Horst Sievert


“To be able to guarantee optimized stroke therapy as soon as possible, disputes over competence among the individual medical societies involved must be ended,” they wrote.

They advocate for the creation of interdisciplinary teams, with diagnostics, patient selection, and follow-up care remaining the core competencies and tasks of neurology; in addition, they call for appropriately trained and experienced physicians – regardless of their specialties – performing acute stroke interventions and endovascular thrombectomy.  

“Such a network must be installed as soon as possible to fulfill the mantra ‘time is brain’ ... and not losing unnecessary time to patient transfer, or continuing to offer only the second-best therapy,” they concluded.
 

Opposition in the United States

Dr. Widimsky explained that this proposal may not be so applicable to the United States, where the need for more clinicians capable of performing stroke thrombectomies does not appear to be as critical, possibly because vascular neurosurgeons as well as neuroradiologists are qualified to undertake these procedures.

In an interview, J. Mocco, MD, director of the cerebrovascular center, department of neurological surgery, at Mount Sinai Health System, New York, confirmed that this was the case.

MDedge News
Dr. J. Mocco


“There is no legitimate data to support the claim that there is a lack of an adequate workforce to provide stroke thrombectomy, at least in the U.S.,” he said, adding that, rather, the primary limitation to patient access is a lack of adequate systems of care. “We should learn from the trauma model, which is strongly evidence based, and provide emergency stroke care in a similarly regionalized manner.”

Dr. Mocco, vice president of the Society of NeuroInterventional Surgery, was not impressed with the current study.

“This paper is a retrospective, single-center, unadjudicated, nonindependent assessor case series and therefore, as the authors acknowledge in the limitations section of their paper, it is invalid to compare these data to the results from high-quality, prospective, core-lab, and independent assessor adjudicated randomized trials,” he said. “The supposition that this trial provides evidence that the reported model should be widely considered lacks scientific rigor.”  

Furthermore, “the interventional cardiology literature is replete with data regarding the importance of technical expertise and content knowledge,” he added. “Why would that community now propose that such expertise and knowledge is not necessary for the brain?”

Dr. Mocco argues that the concept that interventional cardiologists should be fast-tracked to perform stroke interventions because they use similar tools, navigate blood vessels, and are comfortable working in critical situations, does not hold up.

“Liver surgeons and brain surgeons are both familiar with tissue manipulation, are used to operating in critical situations, and use cautery, scissors, and scalpels; but no one would argue that a brain surgeon should be fast-tracked to perform liver surgery, or vice versa.” 

He added: “Stroke patients do not have the luxury of choosing the physician who provides their thrombectomy. We should do everything reasonable to ensure that our systems of care are organized so that these vulnerable patients are treated by physicians who have appropriate knowledge and expertise.” 

This study was supported by the Charles University Research program. The authors and editorialists have disclosed no relevant financial relationships.

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

Cardiologists experienced in cardiac interventions can competently perform stroke thrombectomy after a short period of training, with outcomes comparable to those achieved by neuroradiology centers, a new study suggests.
 

“Using interventional cardiologists in this way will help address the huge unmet need for stroke thrombectomy that currently exists,” senior author Petr Widimsky, MD, said in an interview.

Although this may be a feasible way forward in Europe, there is strong opposition to such a proposal from U.S. neurointerventionalists.  

The study, published in the April 12 issue of JACC: Cardiovascular Interventions, describes the establishment of a stroke thrombectomy program in University Hospital Kralovske Vinohrady, a large tertiary hospital in Prague, Czech Republic.

The hospital did not have a neurointerventional program until 2012 when a joint program was started involving an experienced team of cardiologists, angiologists, and one interventional radiologist who trained the cardiologists on the thrombectomy procedure.

The current paper reports on the outcomes of the 333 patients with large vessel occlusion stroke treated under this program between October 2012 and December 2019.

The decision to perform catheter-based thrombectomy was made by a neurologist and was based on acute stroke clinical symptoms and CT angiographic findings.

Results show that functional clinical outcomes, assessed via the Modified Rankin Scale (mRS) score at 3 months, did not vary significantly across years 2012 to 2019, with a favorable outcome (mRS 0 to 2) achieved in 47.9% of patients.

Symptomatic intracerebral hemorrhage occurred in 19 patients (5.7%) and embolization in a new vascular territory occurred in 6 patients (1.8%), outcomes similar to those of neuroradiology centers.

The desired clinical results were achieved from the onset of the program, without any signs of a learning curve effect, they reported.

“These findings support the potential role of interventional cardiac cath labs in the treatment of acute stroke in regions where this therapy is not readily available due to the lack of neurointerventionalists,” the authors concluded.

“Our main message is that our results were excellent from the beginning,” Dr. Widimsky said. “When centers prepare properly, they can achieve excellent results from the beginning with cardiologists who are experienced in interventional procedures and who have spent sufficient time learning about the brain.”  

The authors noted that despite thrombectomy being an extremely beneficial treatment for severe stroke, many eligible patients remain untreated, largely because of a lack of neurointerventionalists in many regions worldwide. They estimate that about 15% of all stroke patients are eligible for thrombectomy but only around 2% of stroke patients in Europe actually receive such treatment.

Dr. Widimsky, an interventional cardiologist, first thought of the idea of using cardiologists to perform stroke thrombectomies after a good friend and colleague suffered a severe stroke in 2010.

“This made us realize that our hospital needed to be more active in the stroke field,” he said. “We decided that we needed to start doing stroke interventions.”

But the major problem was the lack of neurointerventionalists.

“There are not enough neurointerventionalists in Europe. Interventional cardiologists can perform thousands of procedures every year whereas a neurointerventionalist will at best perform hundreds a year. It is quicker and simpler to train the cardiologist to do it,” Dr. Widimsky said.  

They hired one neurointerventionalist to lead the program. “He was our tutor, he taught us his skills,” Dr. Widimsky said. “The cath lab is open 24/7, but if we only have one neurointerventionalist we cannot offer a 24/7 service for stroke thrombectomy. But if we merge with cardiology then we can,” he added.

Their hospital is a very busy center for myocardial infarctionpercutaneous coronary intervention, and carotid stenting, he noted. “It is not difficult to make the step from that to stroke thrombectomy. Interventional cardiologists are used to performing carotid and coronary artery stenting. Stroke thrombectomy is a similar technique. The thrombectomy procedure is different from coronary angioplasty but it is not more difficult.  Actually, I think coronary angioplasty can be more difficult.”  

Dr. Widimsky explained that cardiologists need to learn about the brain anatomy and physiology and learn the stroke imaging techniques. “I spent 1 month in the U.S. learning stroke interventions working with simulators,” he said. “I think interventional cardiologists can learn what they need to know in about 6 months. I would recommend they should watch about 50 procedures and perform at least 25 under supervision.”

He said this model is the way forward and hopes it will become routine. Thrombectomy is “tremendously effective” in improving outcomes in severe strokes, with a number needed to treat (NNT) of just 2.6 to prevent long-term disability in one patient, he said, while other procedures can have NNTs of 50 or more.  

“But millions of patients with acute severe stroke are not getting this life-changing treatment,” he added. “We must do everything we can to make this service available to as many patients as possible.”

Dr. Widimsky acknowledges that there has been opposition to this idea from the neurointerventionalist professional bodies but this has lessened recently, at least in Europe. And a program that allows interventionalists with experience in extracranial carotid and vertebral endovascular procedures to “fast-track” technical training has now been proposed.

“There is an enormous unmet need for stroke thrombectomy in Europe, with some countries needing to increase the number of procedures done by 10 or 20 times. These include the U.K., Sweden, Italy, Spain, and Portugal. This cannot be done without cardiology,” Dr. Widimsky said.  
 

 

 

Editorial strongly supportive

An accompanying editorial strongly endorses the idea of using interdisciplinary teams to deliver high standard stroke care.

Marius Hornung, MD, and Horst Sievert, MD, from CardioVascular Center Frankfurt (Germany), point out that many experienced cardiologists are trained in performing carotid artery interventions and are therefore experienced in accessing the supra-aortic arteries.

Ted Bosworth/MDedge News
Dr. Horst Sievert


“To be able to guarantee optimized stroke therapy as soon as possible, disputes over competence among the individual medical societies involved must be ended,” they wrote.

They advocate for the creation of interdisciplinary teams, with diagnostics, patient selection, and follow-up care remaining the core competencies and tasks of neurology; in addition, they call for appropriately trained and experienced physicians – regardless of their specialties – performing acute stroke interventions and endovascular thrombectomy.  

“Such a network must be installed as soon as possible to fulfill the mantra ‘time is brain’ ... and not losing unnecessary time to patient transfer, or continuing to offer only the second-best therapy,” they concluded.
 

Opposition in the United States

Dr. Widimsky explained that this proposal may not be so applicable to the United States, where the need for more clinicians capable of performing stroke thrombectomies does not appear to be as critical, possibly because vascular neurosurgeons as well as neuroradiologists are qualified to undertake these procedures.

In an interview, J. Mocco, MD, director of the cerebrovascular center, department of neurological surgery, at Mount Sinai Health System, New York, confirmed that this was the case.

MDedge News
Dr. J. Mocco


“There is no legitimate data to support the claim that there is a lack of an adequate workforce to provide stroke thrombectomy, at least in the U.S.,” he said, adding that, rather, the primary limitation to patient access is a lack of adequate systems of care. “We should learn from the trauma model, which is strongly evidence based, and provide emergency stroke care in a similarly regionalized manner.”

Dr. Mocco, vice president of the Society of NeuroInterventional Surgery, was not impressed with the current study.

“This paper is a retrospective, single-center, unadjudicated, nonindependent assessor case series and therefore, as the authors acknowledge in the limitations section of their paper, it is invalid to compare these data to the results from high-quality, prospective, core-lab, and independent assessor adjudicated randomized trials,” he said. “The supposition that this trial provides evidence that the reported model should be widely considered lacks scientific rigor.”  

Furthermore, “the interventional cardiology literature is replete with data regarding the importance of technical expertise and content knowledge,” he added. “Why would that community now propose that such expertise and knowledge is not necessary for the brain?”

Dr. Mocco argues that the concept that interventional cardiologists should be fast-tracked to perform stroke interventions because they use similar tools, navigate blood vessels, and are comfortable working in critical situations, does not hold up.

“Liver surgeons and brain surgeons are both familiar with tissue manipulation, are used to operating in critical situations, and use cautery, scissors, and scalpels; but no one would argue that a brain surgeon should be fast-tracked to perform liver surgery, or vice versa.” 

He added: “Stroke patients do not have the luxury of choosing the physician who provides their thrombectomy. We should do everything reasonable to ensure that our systems of care are organized so that these vulnerable patients are treated by physicians who have appropriate knowledge and expertise.” 

This study was supported by the Charles University Research program. The authors and editorialists have disclosed no relevant financial relationships.

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

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COVID-19–related inflammatory syndrome tied to neurologic symptoms in children

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About half of children with pediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS) have new-onset neurologic symptoms, research shows.

These symptoms involve the central and peripheral nervous systems but do not always affect the respiratory system. In addition, neurologic symptoms appear to be more common in severe presentations of this syndrome.

“These new data consolidate the initial findings in our JAMA Neurology publication on the neurological problems that children with PIMS-TS can present with, even in the absence of respiratory systems,” study investigator Omar Abdel-Mannan, MD, clinical research fellow at University College London Institute of Neurology and senior resident at Great Ormond Street Hospital for children in London, said in an interview.

He added that the findings are in keeping with other recent research studies on PIMS-TS, which is known more commonly in the United States as multisystem inflammatory syndrome in children (MIS-C).

The findings will be presented April 18 at the American Academy of Neurology (AAN) 2021 Annual Meeting.
 

Neurologic manifestations common

Many children and adults with COVID-19 have developed neurologic manifestations. PIMS-TS is a severe, postinfectious, immune-mediated disorder characterized by persistent fever and extreme inflammation.

Patients may have acute diarrhea or vomiting, rash or bilateral conjunctivitis, and low blood pressure. They should be examined by a pediatric specialist, and most children with this disorder need intensive care.

To report the neurologic manifestations in children with PIMS-TS, the researchers retrospectively examined data for children and adolescents younger than 18 years who had the disorder and presented to a single center between April 4, 2020, and Sept. 1, 2020.

Forty-six patients (median age, 10.2 years) were included in the analysis. Thirty (65.2%) were male, and 37 (80.4%) were of non-White ethnicities.

Twenty-four (52.2%) patients had new-onset neurologic symptoms, which included headache (n = 24), encephalopathy (n = 14 patients), dysarthria/dysphonia (n = 6), hallucinations (n = 6), ataxia (n = 4), peripheral nerve involvement (n = 3), and seizures (n=1).

Laboratory and imaging results provided further information. One patient had 118 leukocytes in cerebrospinal fluid. Children with neurologic involvement had higher levels of peak inflammatory markers and were more likely to be ventilated and require inotropic support in the PICU (P < .05).

Four of 16 patients who underwent brain MRI had splenium signal changes. Of 15 patients who underwent electroencephalogram (EEG), 14 had an excess of slow activity. Four of 7 patients who underwent nerve conduction studies and electromyography (EMG) had myopathic and neuropathic changes.
 

Response to SARS-CoV-2

Central neurologic problems of the brain and peripheral nerve involvement rarely occur at the same time in children.

“This makes it highly possible that the syndrome is secondary to cytokine release in response to the SARS-CoV-2 virus, as there is significant clinical overlap with both genetic and acquired forms of another immune-mediated condition known as hemophagocytic lymphohistiocytosis,” said Dr. Abdel-Mannan.

The researchers found no demographic differences between children with neurologic involvement at presentation and those without.

“However, the numbers are small given the rarity of this condition, which makes it difficult to extrapolate associations and differences between the two groups, and will require future collaborative larger scale studies to look at what potentially makes some children more susceptible to neurologic involvement than others,” said Dr. Abdel-Mannan.

Excluding potential causes of the symptoms other than COVID-19 also is important, he added.

The preponderance of ethnic minorities in the current study population mirrors that in other PIMS-TS cohorts in other countries, said Dr. Abdel-Mannan. It reflects the higher incidence of COVID-19 in ethnic minority groups. However, presentation, investigations, and management did not differ between White and non-White children in the current study.

“Although PIMS-TS patients with neurologic involvement are initially sicker, our center’s preliminary follow-up data up to 6 months post discharge from hospital demonstrates that most of these children make an almost complete functional recovery, which is reassuring,” said Dr. Abdel-Mannan.

The data underscore how important it is that clinicians be aware that children with PIMS-TS can present with neurologic symptoms, even in the absence of respiratory involvement, he added.

The researchers will soon begin a multicenter research study that will involve longitudinal clinical and cognitive assessments and advanced neuroimaging. The objective will be to determine whether all children with PIMS-TS, or only those with neurologic symptoms, are at risk of chronic longer-term neurocognitive and psychiatric outcomes.
 

 

 

Unanswered questions

John B. Bodensteiner, MD, professor of neurology and pediatrics at Mayo Clinic, Rochester, Minn., said in an interview that the findings help flesh out the range of neurologic involvement that PIMS-TS entails.

“It’s not a surprise to us as neurologists, but it’s not been emphasized in the general literature and in the public health sector,” he said.

The study’s most important implication is that neurologic conditions are not uncommon among children with PIMS-TS, Dr. Bodensteiner added.

“We have no idea how long or what the long-term effects of that are,” he said. Not enough time has elapsed to enable a clear understanding of the syndrome’s lasting effects on cognition, he said, “but I think this certainly raises a flag that this is a real entity. This is nothing to sniff at.”

He noted that the study has the limitations of any retrospective case series. The researchers did not perform prospective and systematic evaluations of children with the syndrome

The findings also raise unanswered questions.

“They had 14 kids with encephalopathy, but not all of them got the same evaluation,” said Dr. Bodensteiner. Although the researchers mention peripheral nerve involvement in three children, they do not describe it. “They said that the EMG showed myopathic and neuropathic changes, but peripheral nerve involvement wouldn’t give you myopathic changes, so maybe there’s some direct involvement of the muscle in this inflammatory process.”

The study also focused on a select group of patients, said Dr. Bodensteiner. “These are all patients admitted to Great Ormond Street Hospital, and we don’t know what percentage of kids who get COVID are hospitalized, which is an important issue.”

It is necessary to know what proportion of children with COVID-19 develop encephalopathy and MRI changes, he added. The findings do confirm that this coronavirus-related inflammatory condition is real and may have long-term sequelae. “We should be careful about kids getting this disease,” said Dr. Bodensteiner

The study had no funding. Dr. Abdel-Mannan and Dr. Bodensteiner have disclosed no relevant financial relationships.

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

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About half of children with pediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS) have new-onset neurologic symptoms, research shows.

These symptoms involve the central and peripheral nervous systems but do not always affect the respiratory system. In addition, neurologic symptoms appear to be more common in severe presentations of this syndrome.

“These new data consolidate the initial findings in our JAMA Neurology publication on the neurological problems that children with PIMS-TS can present with, even in the absence of respiratory systems,” study investigator Omar Abdel-Mannan, MD, clinical research fellow at University College London Institute of Neurology and senior resident at Great Ormond Street Hospital for children in London, said in an interview.

He added that the findings are in keeping with other recent research studies on PIMS-TS, which is known more commonly in the United States as multisystem inflammatory syndrome in children (MIS-C).

The findings will be presented April 18 at the American Academy of Neurology (AAN) 2021 Annual Meeting.
 

Neurologic manifestations common

Many children and adults with COVID-19 have developed neurologic manifestations. PIMS-TS is a severe, postinfectious, immune-mediated disorder characterized by persistent fever and extreme inflammation.

Patients may have acute diarrhea or vomiting, rash or bilateral conjunctivitis, and low blood pressure. They should be examined by a pediatric specialist, and most children with this disorder need intensive care.

To report the neurologic manifestations in children with PIMS-TS, the researchers retrospectively examined data for children and adolescents younger than 18 years who had the disorder and presented to a single center between April 4, 2020, and Sept. 1, 2020.

Forty-six patients (median age, 10.2 years) were included in the analysis. Thirty (65.2%) were male, and 37 (80.4%) were of non-White ethnicities.

Twenty-four (52.2%) patients had new-onset neurologic symptoms, which included headache (n = 24), encephalopathy (n = 14 patients), dysarthria/dysphonia (n = 6), hallucinations (n = 6), ataxia (n = 4), peripheral nerve involvement (n = 3), and seizures (n=1).

Laboratory and imaging results provided further information. One patient had 118 leukocytes in cerebrospinal fluid. Children with neurologic involvement had higher levels of peak inflammatory markers and were more likely to be ventilated and require inotropic support in the PICU (P < .05).

Four of 16 patients who underwent brain MRI had splenium signal changes. Of 15 patients who underwent electroencephalogram (EEG), 14 had an excess of slow activity. Four of 7 patients who underwent nerve conduction studies and electromyography (EMG) had myopathic and neuropathic changes.
 

Response to SARS-CoV-2

Central neurologic problems of the brain and peripheral nerve involvement rarely occur at the same time in children.

“This makes it highly possible that the syndrome is secondary to cytokine release in response to the SARS-CoV-2 virus, as there is significant clinical overlap with both genetic and acquired forms of another immune-mediated condition known as hemophagocytic lymphohistiocytosis,” said Dr. Abdel-Mannan.

The researchers found no demographic differences between children with neurologic involvement at presentation and those without.

“However, the numbers are small given the rarity of this condition, which makes it difficult to extrapolate associations and differences between the two groups, and will require future collaborative larger scale studies to look at what potentially makes some children more susceptible to neurologic involvement than others,” said Dr. Abdel-Mannan.

Excluding potential causes of the symptoms other than COVID-19 also is important, he added.

The preponderance of ethnic minorities in the current study population mirrors that in other PIMS-TS cohorts in other countries, said Dr. Abdel-Mannan. It reflects the higher incidence of COVID-19 in ethnic minority groups. However, presentation, investigations, and management did not differ between White and non-White children in the current study.

“Although PIMS-TS patients with neurologic involvement are initially sicker, our center’s preliminary follow-up data up to 6 months post discharge from hospital demonstrates that most of these children make an almost complete functional recovery, which is reassuring,” said Dr. Abdel-Mannan.

The data underscore how important it is that clinicians be aware that children with PIMS-TS can present with neurologic symptoms, even in the absence of respiratory involvement, he added.

The researchers will soon begin a multicenter research study that will involve longitudinal clinical and cognitive assessments and advanced neuroimaging. The objective will be to determine whether all children with PIMS-TS, or only those with neurologic symptoms, are at risk of chronic longer-term neurocognitive and psychiatric outcomes.
 

 

 

Unanswered questions

John B. Bodensteiner, MD, professor of neurology and pediatrics at Mayo Clinic, Rochester, Minn., said in an interview that the findings help flesh out the range of neurologic involvement that PIMS-TS entails.

“It’s not a surprise to us as neurologists, but it’s not been emphasized in the general literature and in the public health sector,” he said.

The study’s most important implication is that neurologic conditions are not uncommon among children with PIMS-TS, Dr. Bodensteiner added.

“We have no idea how long or what the long-term effects of that are,” he said. Not enough time has elapsed to enable a clear understanding of the syndrome’s lasting effects on cognition, he said, “but I think this certainly raises a flag that this is a real entity. This is nothing to sniff at.”

He noted that the study has the limitations of any retrospective case series. The researchers did not perform prospective and systematic evaluations of children with the syndrome

The findings also raise unanswered questions.

“They had 14 kids with encephalopathy, but not all of them got the same evaluation,” said Dr. Bodensteiner. Although the researchers mention peripheral nerve involvement in three children, they do not describe it. “They said that the EMG showed myopathic and neuropathic changes, but peripheral nerve involvement wouldn’t give you myopathic changes, so maybe there’s some direct involvement of the muscle in this inflammatory process.”

The study also focused on a select group of patients, said Dr. Bodensteiner. “These are all patients admitted to Great Ormond Street Hospital, and we don’t know what percentage of kids who get COVID are hospitalized, which is an important issue.”

It is necessary to know what proportion of children with COVID-19 develop encephalopathy and MRI changes, he added. The findings do confirm that this coronavirus-related inflammatory condition is real and may have long-term sequelae. “We should be careful about kids getting this disease,” said Dr. Bodensteiner

The study had no funding. Dr. Abdel-Mannan and Dr. Bodensteiner have disclosed no relevant financial relationships.

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

 

About half of children with pediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS) have new-onset neurologic symptoms, research shows.

These symptoms involve the central and peripheral nervous systems but do not always affect the respiratory system. In addition, neurologic symptoms appear to be more common in severe presentations of this syndrome.

“These new data consolidate the initial findings in our JAMA Neurology publication on the neurological problems that children with PIMS-TS can present with, even in the absence of respiratory systems,” study investigator Omar Abdel-Mannan, MD, clinical research fellow at University College London Institute of Neurology and senior resident at Great Ormond Street Hospital for children in London, said in an interview.

He added that the findings are in keeping with other recent research studies on PIMS-TS, which is known more commonly in the United States as multisystem inflammatory syndrome in children (MIS-C).

The findings will be presented April 18 at the American Academy of Neurology (AAN) 2021 Annual Meeting.
 

Neurologic manifestations common

Many children and adults with COVID-19 have developed neurologic manifestations. PIMS-TS is a severe, postinfectious, immune-mediated disorder characterized by persistent fever and extreme inflammation.

Patients may have acute diarrhea or vomiting, rash or bilateral conjunctivitis, and low blood pressure. They should be examined by a pediatric specialist, and most children with this disorder need intensive care.

To report the neurologic manifestations in children with PIMS-TS, the researchers retrospectively examined data for children and adolescents younger than 18 years who had the disorder and presented to a single center between April 4, 2020, and Sept. 1, 2020.

Forty-six patients (median age, 10.2 years) were included in the analysis. Thirty (65.2%) were male, and 37 (80.4%) were of non-White ethnicities.

Twenty-four (52.2%) patients had new-onset neurologic symptoms, which included headache (n = 24), encephalopathy (n = 14 patients), dysarthria/dysphonia (n = 6), hallucinations (n = 6), ataxia (n = 4), peripheral nerve involvement (n = 3), and seizures (n=1).

Laboratory and imaging results provided further information. One patient had 118 leukocytes in cerebrospinal fluid. Children with neurologic involvement had higher levels of peak inflammatory markers and were more likely to be ventilated and require inotropic support in the PICU (P < .05).

Four of 16 patients who underwent brain MRI had splenium signal changes. Of 15 patients who underwent electroencephalogram (EEG), 14 had an excess of slow activity. Four of 7 patients who underwent nerve conduction studies and electromyography (EMG) had myopathic and neuropathic changes.
 

Response to SARS-CoV-2

Central neurologic problems of the brain and peripheral nerve involvement rarely occur at the same time in children.

“This makes it highly possible that the syndrome is secondary to cytokine release in response to the SARS-CoV-2 virus, as there is significant clinical overlap with both genetic and acquired forms of another immune-mediated condition known as hemophagocytic lymphohistiocytosis,” said Dr. Abdel-Mannan.

The researchers found no demographic differences between children with neurologic involvement at presentation and those without.

“However, the numbers are small given the rarity of this condition, which makes it difficult to extrapolate associations and differences between the two groups, and will require future collaborative larger scale studies to look at what potentially makes some children more susceptible to neurologic involvement than others,” said Dr. Abdel-Mannan.

Excluding potential causes of the symptoms other than COVID-19 also is important, he added.

The preponderance of ethnic minorities in the current study population mirrors that in other PIMS-TS cohorts in other countries, said Dr. Abdel-Mannan. It reflects the higher incidence of COVID-19 in ethnic minority groups. However, presentation, investigations, and management did not differ between White and non-White children in the current study.

“Although PIMS-TS patients with neurologic involvement are initially sicker, our center’s preliminary follow-up data up to 6 months post discharge from hospital demonstrates that most of these children make an almost complete functional recovery, which is reassuring,” said Dr. Abdel-Mannan.

The data underscore how important it is that clinicians be aware that children with PIMS-TS can present with neurologic symptoms, even in the absence of respiratory involvement, he added.

The researchers will soon begin a multicenter research study that will involve longitudinal clinical and cognitive assessments and advanced neuroimaging. The objective will be to determine whether all children with PIMS-TS, or only those with neurologic symptoms, are at risk of chronic longer-term neurocognitive and psychiatric outcomes.
 

 

 

Unanswered questions

John B. Bodensteiner, MD, professor of neurology and pediatrics at Mayo Clinic, Rochester, Minn., said in an interview that the findings help flesh out the range of neurologic involvement that PIMS-TS entails.

“It’s not a surprise to us as neurologists, but it’s not been emphasized in the general literature and in the public health sector,” he said.

The study’s most important implication is that neurologic conditions are not uncommon among children with PIMS-TS, Dr. Bodensteiner added.

“We have no idea how long or what the long-term effects of that are,” he said. Not enough time has elapsed to enable a clear understanding of the syndrome’s lasting effects on cognition, he said, “but I think this certainly raises a flag that this is a real entity. This is nothing to sniff at.”

He noted that the study has the limitations of any retrospective case series. The researchers did not perform prospective and systematic evaluations of children with the syndrome

The findings also raise unanswered questions.

“They had 14 kids with encephalopathy, but not all of them got the same evaluation,” said Dr. Bodensteiner. Although the researchers mention peripheral nerve involvement in three children, they do not describe it. “They said that the EMG showed myopathic and neuropathic changes, but peripheral nerve involvement wouldn’t give you myopathic changes, so maybe there’s some direct involvement of the muscle in this inflammatory process.”

The study also focused on a select group of patients, said Dr. Bodensteiner. “These are all patients admitted to Great Ormond Street Hospital, and we don’t know what percentage of kids who get COVID are hospitalized, which is an important issue.”

It is necessary to know what proportion of children with COVID-19 develop encephalopathy and MRI changes, he added. The findings do confirm that this coronavirus-related inflammatory condition is real and may have long-term sequelae. “We should be careful about kids getting this disease,” said Dr. Bodensteiner

The study had no funding. Dr. Abdel-Mannan and Dr. Bodensteiner have disclosed no relevant financial relationships.

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

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Phage-targeting PCR test picks up early Lyme disease

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Fri, 04/16/2021 - 11:29

An investigational polymerase chain reaction (PCR) test that detects the presence of a viral gene in Lyme disease–causing bacteria can distinguish between early and late infection, according to the results of a study that the authors described as “systematic and comprehensive.”

Dr. Jinyu Shan

“The current way of diagnosing Lyme disease is struggling to reflect the ‘true’ incidence of Lyme disease,” study investigator Jinyu Shan, PhD, said in an interview. Although there are tests for Lyme disease approved by the Food and Drug Administration, they are based on the development of antibodies in the blood, and the problem is that antibodies might not develop until several weeks after an infection.

Diagnosis therefore still relies heavily on the clinician’s experience. There are often telltale signs – such as a “bullseye” skin rash or having been to an area known to be infested with ticks that carry Lyme disease – but this might not always be the case.

For the new test, “we’re not targeting bacteria. We’re targeting bacteriophages,” said Dr. Shan, a research fellow in the department of genetics and genome biology at the University of Leicester (England).

Fortunately, there’s high correlation between the presence of the terL gene and the presence of Borrelia burgdorferi, the spirochete that causes Lyme disease. “If you find the bacteriophages, the bacteria are there,” said Dr. Shan.



“Importantly, there are 10 times more bacteriophages, compared with the bacteria, so you have a lot more targets,” he added.

In an evaluation of a total of 312 samples (156 whole blood and 156 serum samples), significantly fewer copies of the terL gene were found in samples from people with early Lyme disease than in those with late Lyme disease, whereas the fewest copies of terL were seen in healthy volunteers.

Most pathogenic bacteria carry viral DNA either as multiple complete or partial prophages, Dr. Shan explained. Knowing the prophage sequences means that quantitative PCR primers and probes can be designed and used to detect the presence of the associated bacteria.

Although the novel test still needs evaluation in a clinical trial, it could represent a “step-change” in the detection of Lyme disease, Dr. Shan and associates suggested in their report published in Frontiers in Microbiology.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

Early treatment is key to the prevention of longer-term consequences of Lyme disease. Clinicians familiar with the treatment of Lyme disease might choose to initiate antibiotic treatment without a positive lab test. However, the lack of a test that can pick out people with Lyme disease in the first few weeks of infection means that many people are not diagnosed or treated early enough.

The new phage-based PCR test Dr. Shan and associates have developed could change all that. With only 0.3 mL of blood being needed, it can potentially be developed as a simple point-of-care test, but that’s a long way off.

At this stage, the research is very much a “proof of concept,” Dr. Shan said. One of the things he plans to try to work out next is whether the test can distinguish between active and dormant disease, which is a “big question” in the diagnosis of Lyme disease.

“Bacteriophages can only be sustained by actively growing bacteria,” explained Dr. Shan, so there is a chance that if they are present in a substantive amount the disease is active, and if they are not – or are in very low numbers – then the disease is dormant. The cutoff value, however, “is not trivial to establish, but we are working toward it,” added Dr. Shan.

Over the past 2 years, Dr. Shan and associates have been working with the Belgian-based diagnostics company, R.E.D Laboratories, to see how the test will fare in a real-world environment. This relationship is providing useful information to add to their bid to perform a clinical trial for which they are now seeking additional sponsorship.



“The lack of an early and effective diagnosis of Lyme disease remains a major cause of misdiagnosis and long-term patient suffering,” commented Rosie Milsom, charity manager for Caudwell LymeCo Charity in the United Kingdom.

It could be a game changer if the test passes the necessary clinical trial testing and validation stages, noted Ms. Milsom, who was not involved in the research.

“Not only would the test help to establish the level or length of infection,” she said, “but it could also act as a way to test after treatment to see if the infection levels are decreasing.” If levels are still high, “you would know more treatment is needed.

The research is being funded by the charity Phelix Research and Development with support from the University of Leicester and the Dutch-based Lyme Fund, Lymefonds. Dr. Shan is named as coinventor of the phage-targeting PCR test, alongside Martha R.J. Clokie, professor of microbiology at the University of Leicester and the senior author of the study. Dr. Shan is chief scientific officer for Phelix Research and Development. Ms. Clokie and other coauthors hold key positions within the medical research charity.

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

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An investigational polymerase chain reaction (PCR) test that detects the presence of a viral gene in Lyme disease–causing bacteria can distinguish between early and late infection, according to the results of a study that the authors described as “systematic and comprehensive.”

Dr. Jinyu Shan

“The current way of diagnosing Lyme disease is struggling to reflect the ‘true’ incidence of Lyme disease,” study investigator Jinyu Shan, PhD, said in an interview. Although there are tests for Lyme disease approved by the Food and Drug Administration, they are based on the development of antibodies in the blood, and the problem is that antibodies might not develop until several weeks after an infection.

Diagnosis therefore still relies heavily on the clinician’s experience. There are often telltale signs – such as a “bullseye” skin rash or having been to an area known to be infested with ticks that carry Lyme disease – but this might not always be the case.

For the new test, “we’re not targeting bacteria. We’re targeting bacteriophages,” said Dr. Shan, a research fellow in the department of genetics and genome biology at the University of Leicester (England).

Fortunately, there’s high correlation between the presence of the terL gene and the presence of Borrelia burgdorferi, the spirochete that causes Lyme disease. “If you find the bacteriophages, the bacteria are there,” said Dr. Shan.



“Importantly, there are 10 times more bacteriophages, compared with the bacteria, so you have a lot more targets,” he added.

In an evaluation of a total of 312 samples (156 whole blood and 156 serum samples), significantly fewer copies of the terL gene were found in samples from people with early Lyme disease than in those with late Lyme disease, whereas the fewest copies of terL were seen in healthy volunteers.

Most pathogenic bacteria carry viral DNA either as multiple complete or partial prophages, Dr. Shan explained. Knowing the prophage sequences means that quantitative PCR primers and probes can be designed and used to detect the presence of the associated bacteria.

Although the novel test still needs evaluation in a clinical trial, it could represent a “step-change” in the detection of Lyme disease, Dr. Shan and associates suggested in their report published in Frontiers in Microbiology.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

Early treatment is key to the prevention of longer-term consequences of Lyme disease. Clinicians familiar with the treatment of Lyme disease might choose to initiate antibiotic treatment without a positive lab test. However, the lack of a test that can pick out people with Lyme disease in the first few weeks of infection means that many people are not diagnosed or treated early enough.

The new phage-based PCR test Dr. Shan and associates have developed could change all that. With only 0.3 mL of blood being needed, it can potentially be developed as a simple point-of-care test, but that’s a long way off.

At this stage, the research is very much a “proof of concept,” Dr. Shan said. One of the things he plans to try to work out next is whether the test can distinguish between active and dormant disease, which is a “big question” in the diagnosis of Lyme disease.

“Bacteriophages can only be sustained by actively growing bacteria,” explained Dr. Shan, so there is a chance that if they are present in a substantive amount the disease is active, and if they are not – or are in very low numbers – then the disease is dormant. The cutoff value, however, “is not trivial to establish, but we are working toward it,” added Dr. Shan.

Over the past 2 years, Dr. Shan and associates have been working with the Belgian-based diagnostics company, R.E.D Laboratories, to see how the test will fare in a real-world environment. This relationship is providing useful information to add to their bid to perform a clinical trial for which they are now seeking additional sponsorship.



“The lack of an early and effective diagnosis of Lyme disease remains a major cause of misdiagnosis and long-term patient suffering,” commented Rosie Milsom, charity manager for Caudwell LymeCo Charity in the United Kingdom.

It could be a game changer if the test passes the necessary clinical trial testing and validation stages, noted Ms. Milsom, who was not involved in the research.

“Not only would the test help to establish the level or length of infection,” she said, “but it could also act as a way to test after treatment to see if the infection levels are decreasing.” If levels are still high, “you would know more treatment is needed.

The research is being funded by the charity Phelix Research and Development with support from the University of Leicester and the Dutch-based Lyme Fund, Lymefonds. Dr. Shan is named as coinventor of the phage-targeting PCR test, alongside Martha R.J. Clokie, professor of microbiology at the University of Leicester and the senior author of the study. Dr. Shan is chief scientific officer for Phelix Research and Development. Ms. Clokie and other coauthors hold key positions within the medical research charity.

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

An investigational polymerase chain reaction (PCR) test that detects the presence of a viral gene in Lyme disease–causing bacteria can distinguish between early and late infection, according to the results of a study that the authors described as “systematic and comprehensive.”

Dr. Jinyu Shan

“The current way of diagnosing Lyme disease is struggling to reflect the ‘true’ incidence of Lyme disease,” study investigator Jinyu Shan, PhD, said in an interview. Although there are tests for Lyme disease approved by the Food and Drug Administration, they are based on the development of antibodies in the blood, and the problem is that antibodies might not develop until several weeks after an infection.

Diagnosis therefore still relies heavily on the clinician’s experience. There are often telltale signs – such as a “bullseye” skin rash or having been to an area known to be infested with ticks that carry Lyme disease – but this might not always be the case.

For the new test, “we’re not targeting bacteria. We’re targeting bacteriophages,” said Dr. Shan, a research fellow in the department of genetics and genome biology at the University of Leicester (England).

Fortunately, there’s high correlation between the presence of the terL gene and the presence of Borrelia burgdorferi, the spirochete that causes Lyme disease. “If you find the bacteriophages, the bacteria are there,” said Dr. Shan.



“Importantly, there are 10 times more bacteriophages, compared with the bacteria, so you have a lot more targets,” he added.

In an evaluation of a total of 312 samples (156 whole blood and 156 serum samples), significantly fewer copies of the terL gene were found in samples from people with early Lyme disease than in those with late Lyme disease, whereas the fewest copies of terL were seen in healthy volunteers.

Most pathogenic bacteria carry viral DNA either as multiple complete or partial prophages, Dr. Shan explained. Knowing the prophage sequences means that quantitative PCR primers and probes can be designed and used to detect the presence of the associated bacteria.

Although the novel test still needs evaluation in a clinical trial, it could represent a “step-change” in the detection of Lyme disease, Dr. Shan and associates suggested in their report published in Frontiers in Microbiology.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

Early treatment is key to the prevention of longer-term consequences of Lyme disease. Clinicians familiar with the treatment of Lyme disease might choose to initiate antibiotic treatment without a positive lab test. However, the lack of a test that can pick out people with Lyme disease in the first few weeks of infection means that many people are not diagnosed or treated early enough.

The new phage-based PCR test Dr. Shan and associates have developed could change all that. With only 0.3 mL of blood being needed, it can potentially be developed as a simple point-of-care test, but that’s a long way off.

At this stage, the research is very much a “proof of concept,” Dr. Shan said. One of the things he plans to try to work out next is whether the test can distinguish between active and dormant disease, which is a “big question” in the diagnosis of Lyme disease.

“Bacteriophages can only be sustained by actively growing bacteria,” explained Dr. Shan, so there is a chance that if they are present in a substantive amount the disease is active, and if they are not – or are in very low numbers – then the disease is dormant. The cutoff value, however, “is not trivial to establish, but we are working toward it,” added Dr. Shan.

Over the past 2 years, Dr. Shan and associates have been working with the Belgian-based diagnostics company, R.E.D Laboratories, to see how the test will fare in a real-world environment. This relationship is providing useful information to add to their bid to perform a clinical trial for which they are now seeking additional sponsorship.



“The lack of an early and effective diagnosis of Lyme disease remains a major cause of misdiagnosis and long-term patient suffering,” commented Rosie Milsom, charity manager for Caudwell LymeCo Charity in the United Kingdom.

It could be a game changer if the test passes the necessary clinical trial testing and validation stages, noted Ms. Milsom, who was not involved in the research.

“Not only would the test help to establish the level or length of infection,” she said, “but it could also act as a way to test after treatment to see if the infection levels are decreasing.” If levels are still high, “you would know more treatment is needed.

The research is being funded by the charity Phelix Research and Development with support from the University of Leicester and the Dutch-based Lyme Fund, Lymefonds. Dr. Shan is named as coinventor of the phage-targeting PCR test, alongside Martha R.J. Clokie, professor of microbiology at the University of Leicester and the senior author of the study. Dr. Shan is chief scientific officer for Phelix Research and Development. Ms. Clokie and other coauthors hold key positions within the medical research charity.

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

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Highlights from ACTRIMS/ECTRIMS

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Elevations in serum neurofilament light chain levels in people with multiple sclerosis (MS) are significantly linked to worse neurologic function, clinical disability, and lower brain volumes, according to new findings from a large, diverse population of patients with MS. “This is one of the largest studies to evaluate serum neurofilament light chain levels in people with MS,” said lead author Elias S. Sotirchos, MD, an assistant professor of neurology at Johns Hopkins University, Baltimore. “An important strength of this cohort is that it is a realworld cohort of patients followed in U.S. and European MS centers,” he said. “The study captures the diversity of the MS population, including demographics, comorbidities, lifestyle factors, and clinical characteristics that may otherwise not be captured in a clinical trial population.” The research was presented at the 2021 ACTRIMS Forum.

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Read the supplement here or by clicking on the image

Elevations in serum neurofilament light chain levels in people with multiple sclerosis (MS) are significantly linked to worse neurologic function, clinical disability, and lower brain volumes, according to new findings from a large, diverse population of patients with MS. “This is one of the largest studies to evaluate serum neurofilament light chain levels in people with MS,” said lead author Elias S. Sotirchos, MD, an assistant professor of neurology at Johns Hopkins University, Baltimore. “An important strength of this cohort is that it is a realworld cohort of patients followed in U.S. and European MS centers,” he said. “The study captures the diversity of the MS population, including demographics, comorbidities, lifestyle factors, and clinical characteristics that may otherwise not be captured in a clinical trial population.” The research was presented at the 2021 ACTRIMS Forum.

Read the supplement here or by clicking on the image

Elevations in serum neurofilament light chain levels in people with multiple sclerosis (MS) are significantly linked to worse neurologic function, clinical disability, and lower brain volumes, according to new findings from a large, diverse population of patients with MS. “This is one of the largest studies to evaluate serum neurofilament light chain levels in people with MS,” said lead author Elias S. Sotirchos, MD, an assistant professor of neurology at Johns Hopkins University, Baltimore. “An important strength of this cohort is that it is a realworld cohort of patients followed in U.S. and European MS centers,” he said. “The study captures the diversity of the MS population, including demographics, comorbidities, lifestyle factors, and clinical characteristics that may otherwise not be captured in a clinical trial population.” The research was presented at the 2021 ACTRIMS Forum.

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COVID vaccine ‘side effect’ or functional neurologic disorder?

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The development of unusual movements after COVID-19 vaccination may be a result of functional neurologic disorder rather than being a direct adverse effect of the vaccine, it has been suggested.

Writing in an article published online in JAMA Neurology on April 9, 2021, two neurologists and a psychiatrist report the recent circulation of videos on social media about major neurologic adverse events, including continuous movements of the trunk and limbs or walking difficulties after administration of the COVID-19 vaccine. Some of these videos have been viewed millions of times by the public, they noted.

While these videos may be unsubstantiated, and it is not definitively known if the COVID-19 vaccine was administered in these cases, it was reported in the news that at least one patient was told by their physician that the diagnosis was conversion disorder, also known as functional neurological disorder (FND), the authors noted.

In addition, the Functional Neurological Disorder Society released a statement in January 2021 pointing out that the conditions described in these videos are seemingly consistent with FND, they added.

“We thought it would be useful to explain more about what functional neurological disorder is, as many people are not familiar with it,” lead author David Kim, MD, said in an interview. “We wanted to provide some contextual information about the condition, as these reports may not necessarily mean the vaccine is unsafe.”

Dr. Kim, who is part of the division of cognitive behavioral neurology at Massachusetts General Hospital, Boston, explained that, in FND, physical symptoms can be brought about after events such as head injury, surgery, vaccination, other medical procedures, or life events such as loss of employment.

“Many different factors can bring these symptoms on, and while there are definitely cases associated with stressful events, it is not necessarily stress induced,” he said. “However, the event itself does not cause the condition, rather it is the reaction of the patient to the event.”

FND is now viewed as a true brain-based disorder, Dr. Kim noted. “While in the past it has been described as psychosomatic, we are now moving away from that terminology, toward the idea of a neurological disorder that affects function. It is a neuropsychiatric disorder on the borderline between neurology and psychiatry.”

The authors believed that some of these cases of unusual movements reported after COVID vaccination are likely to be FND.

“In these cases, it is not the substance in the vaccine that is causing the condition, but the common side effects that can occur after vaccination such as aches and chills bring the attention of the patient to their bodily functions and this reaction can become maladaptive, triggering FND,” Dr. Kim said.

“We believe that health care professionals should be more aware of FND at the current time. They need to know that the general public are aware that some people are experiencing movement disorders after COVID vaccination, and that this conversation is happening on social media,” he commented. “If they see patients with these symptoms, they could consider FND to be one possibility.”

The authors emphasized that, because they have not seen the individual patients, they cannot comment on any specific cases.

“But as some of these videos circulating can be consistent with the condition being FND, and especially with news reports indicating that at least one patient was given that diagnosis, we wanted to raise awareness of this condition among health professionals,” Dr. Kim added.  

He explained that, in the past, FND has been a diagnosis of exclusion but now it is diagnosed with a clinical history and physical examination, looking for appropriate rule-in signs. Ancillary testing such as neuroimaging, electrophysiological studies, and blood tests are often used to rule out other conditions.

“Neurologists have a lot of training in this condition, as it is the second most common reason for a patient to visit a neurologist after headache,” Dr. Kim noted.

It is managed with education, counseling, physical rehabilitation and cognitive behavioral therapy. “A key part of the therapeutic process is working with the patient to explain the diagnosis. If they understand the condition, they do better. Patients can learn distraction techniques to allow more fluid movements,” he reported.

“As neurologists, and health care professionals more broadly, we must explain transparently and nonjudgmentally the nature of FND, including that these symptoms are real but not the direct result of toxic vaccine effects,” the authors wrote.

“Transparency and effective communication are needed in our society more than ever, and a condition as prevalent and potentially debilitating as FND can no longer remain marginalized and in the shadows. Effective communication will help educate the public and reduce fears so that patients can make informed decisions for themselves on receiving the vaccine to reduce the risk of COVID-19,” they concluded.

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

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The development of unusual movements after COVID-19 vaccination may be a result of functional neurologic disorder rather than being a direct adverse effect of the vaccine, it has been suggested.

Writing in an article published online in JAMA Neurology on April 9, 2021, two neurologists and a psychiatrist report the recent circulation of videos on social media about major neurologic adverse events, including continuous movements of the trunk and limbs or walking difficulties after administration of the COVID-19 vaccine. Some of these videos have been viewed millions of times by the public, they noted.

While these videos may be unsubstantiated, and it is not definitively known if the COVID-19 vaccine was administered in these cases, it was reported in the news that at least one patient was told by their physician that the diagnosis was conversion disorder, also known as functional neurological disorder (FND), the authors noted.

In addition, the Functional Neurological Disorder Society released a statement in January 2021 pointing out that the conditions described in these videos are seemingly consistent with FND, they added.

“We thought it would be useful to explain more about what functional neurological disorder is, as many people are not familiar with it,” lead author David Kim, MD, said in an interview. “We wanted to provide some contextual information about the condition, as these reports may not necessarily mean the vaccine is unsafe.”

Dr. Kim, who is part of the division of cognitive behavioral neurology at Massachusetts General Hospital, Boston, explained that, in FND, physical symptoms can be brought about after events such as head injury, surgery, vaccination, other medical procedures, or life events such as loss of employment.

“Many different factors can bring these symptoms on, and while there are definitely cases associated with stressful events, it is not necessarily stress induced,” he said. “However, the event itself does not cause the condition, rather it is the reaction of the patient to the event.”

FND is now viewed as a true brain-based disorder, Dr. Kim noted. “While in the past it has been described as psychosomatic, we are now moving away from that terminology, toward the idea of a neurological disorder that affects function. It is a neuropsychiatric disorder on the borderline between neurology and psychiatry.”

The authors believed that some of these cases of unusual movements reported after COVID vaccination are likely to be FND.

“In these cases, it is not the substance in the vaccine that is causing the condition, but the common side effects that can occur after vaccination such as aches and chills bring the attention of the patient to their bodily functions and this reaction can become maladaptive, triggering FND,” Dr. Kim said.

“We believe that health care professionals should be more aware of FND at the current time. They need to know that the general public are aware that some people are experiencing movement disorders after COVID vaccination, and that this conversation is happening on social media,” he commented. “If they see patients with these symptoms, they could consider FND to be one possibility.”

The authors emphasized that, because they have not seen the individual patients, they cannot comment on any specific cases.

“But as some of these videos circulating can be consistent with the condition being FND, and especially with news reports indicating that at least one patient was given that diagnosis, we wanted to raise awareness of this condition among health professionals,” Dr. Kim added.  

He explained that, in the past, FND has been a diagnosis of exclusion but now it is diagnosed with a clinical history and physical examination, looking for appropriate rule-in signs. Ancillary testing such as neuroimaging, electrophysiological studies, and blood tests are often used to rule out other conditions.

“Neurologists have a lot of training in this condition, as it is the second most common reason for a patient to visit a neurologist after headache,” Dr. Kim noted.

It is managed with education, counseling, physical rehabilitation and cognitive behavioral therapy. “A key part of the therapeutic process is working with the patient to explain the diagnosis. If they understand the condition, they do better. Patients can learn distraction techniques to allow more fluid movements,” he reported.

“As neurologists, and health care professionals more broadly, we must explain transparently and nonjudgmentally the nature of FND, including that these symptoms are real but not the direct result of toxic vaccine effects,” the authors wrote.

“Transparency and effective communication are needed in our society more than ever, and a condition as prevalent and potentially debilitating as FND can no longer remain marginalized and in the shadows. Effective communication will help educate the public and reduce fears so that patients can make informed decisions for themselves on receiving the vaccine to reduce the risk of COVID-19,” they concluded.

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

 

The development of unusual movements after COVID-19 vaccination may be a result of functional neurologic disorder rather than being a direct adverse effect of the vaccine, it has been suggested.

Writing in an article published online in JAMA Neurology on April 9, 2021, two neurologists and a psychiatrist report the recent circulation of videos on social media about major neurologic adverse events, including continuous movements of the trunk and limbs or walking difficulties after administration of the COVID-19 vaccine. Some of these videos have been viewed millions of times by the public, they noted.

While these videos may be unsubstantiated, and it is not definitively known if the COVID-19 vaccine was administered in these cases, it was reported in the news that at least one patient was told by their physician that the diagnosis was conversion disorder, also known as functional neurological disorder (FND), the authors noted.

In addition, the Functional Neurological Disorder Society released a statement in January 2021 pointing out that the conditions described in these videos are seemingly consistent with FND, they added.

“We thought it would be useful to explain more about what functional neurological disorder is, as many people are not familiar with it,” lead author David Kim, MD, said in an interview. “We wanted to provide some contextual information about the condition, as these reports may not necessarily mean the vaccine is unsafe.”

Dr. Kim, who is part of the division of cognitive behavioral neurology at Massachusetts General Hospital, Boston, explained that, in FND, physical symptoms can be brought about after events such as head injury, surgery, vaccination, other medical procedures, or life events such as loss of employment.

“Many different factors can bring these symptoms on, and while there are definitely cases associated with stressful events, it is not necessarily stress induced,” he said. “However, the event itself does not cause the condition, rather it is the reaction of the patient to the event.”

FND is now viewed as a true brain-based disorder, Dr. Kim noted. “While in the past it has been described as psychosomatic, we are now moving away from that terminology, toward the idea of a neurological disorder that affects function. It is a neuropsychiatric disorder on the borderline between neurology and psychiatry.”

The authors believed that some of these cases of unusual movements reported after COVID vaccination are likely to be FND.

“In these cases, it is not the substance in the vaccine that is causing the condition, but the common side effects that can occur after vaccination such as aches and chills bring the attention of the patient to their bodily functions and this reaction can become maladaptive, triggering FND,” Dr. Kim said.

“We believe that health care professionals should be more aware of FND at the current time. They need to know that the general public are aware that some people are experiencing movement disorders after COVID vaccination, and that this conversation is happening on social media,” he commented. “If they see patients with these symptoms, they could consider FND to be one possibility.”

The authors emphasized that, because they have not seen the individual patients, they cannot comment on any specific cases.

“But as some of these videos circulating can be consistent with the condition being FND, and especially with news reports indicating that at least one patient was given that diagnosis, we wanted to raise awareness of this condition among health professionals,” Dr. Kim added.  

He explained that, in the past, FND has been a diagnosis of exclusion but now it is diagnosed with a clinical history and physical examination, looking for appropriate rule-in signs. Ancillary testing such as neuroimaging, electrophysiological studies, and blood tests are often used to rule out other conditions.

“Neurologists have a lot of training in this condition, as it is the second most common reason for a patient to visit a neurologist after headache,” Dr. Kim noted.

It is managed with education, counseling, physical rehabilitation and cognitive behavioral therapy. “A key part of the therapeutic process is working with the patient to explain the diagnosis. If they understand the condition, they do better. Patients can learn distraction techniques to allow more fluid movements,” he reported.

“As neurologists, and health care professionals more broadly, we must explain transparently and nonjudgmentally the nature of FND, including that these symptoms are real but not the direct result of toxic vaccine effects,” the authors wrote.

“Transparency and effective communication are needed in our society more than ever, and a condition as prevalent and potentially debilitating as FND can no longer remain marginalized and in the shadows. Effective communication will help educate the public and reduce fears so that patients can make informed decisions for themselves on receiving the vaccine to reduce the risk of COVID-19,” they concluded.

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

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CDC panel: Pause of J&J COVID-19 vaccine to remain for now

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Thu, 08/26/2021 - 15:48

The recommended pause in use of the Johnson & Johnson COVID-19 vaccine will last at least another week after a Centers for Disease Control and Prevention advisory committee on April 14 decided not to take action.

Johnson &amp; Johnson

The Advisory Committee on Immunization Practices decided there was not adequate information to change again recommend use of the Johnson & Johnson vaccine.

The committee’s decision comes the day after the CDC and Food and Drug Administration recommended that J&J injections be paused after reports of rare, but serious types of blood clots in six patients among the 6.8 million people who had received the J&J vaccine in the United States.

A member of the committee, Beth Bell, MD, said: “I do not want to be sending a message that there is some huge concern here on a different order of magnitude than any other vaccine safety signals that we evaluate. And I don’t want to send a message that there is something fundamentally wrong with the vaccine because that also I don’t agree with.”

At the end of the 4-hour meeting, ACIP members decided to call a meeting in 1 or 2 weeks and evaluate more safety data, specifically reports of people who have received the J&J vaccine in the past 2 weeks.

Some, however, pointed out that delaying a decision could have substantial consequences as well in terms of unused vaccine doses and public confidence.

Committee member Camiile Kotton, MD, described the pause as “devastating.”

“Putting this vaccine on pause for those of us that are frontline health care workers has really been devastating,” she said. “I agree in general that we don’t have enough data to make a decision at this time but we were planning on using this vaccine in the state of Massachusetts for people who were homebound and otherwise not able to get a vaccine. We were planning on using it for our vulnerable inpatient population often with many comorbidities and at high risk for disease but haven’t been able to get vaccinated otherwise.”

Pausing the one-and-done vaccine that doesn’t have the significant refrigeration requirements of the others “is a significant loss,” she said.
 

What is known, not known

Sara Oliver, MD, who leads the COVID-19 Vaccines ACIP Work Group, summarized what is known and unknown about the blood clots.

Among the six cases of cerebral venous sinus thrombosis reported to the Vaccine Adverse Event Reporting System after the J&J shot, all were women aged 18-48 years and all developed the clots 6-13 days after receiving the vaccine.

No cases of these clots have been reported from either the Pfizer or Moderna shots, she noted.

In the United States, the two mRNA vaccine alternatives – the Moderna and Pfizer vaccines – are available “and based on current projections supply of both vaccines are expected to be relatively stable in the near future,” she said.

She said 14 million doses of Pfizer and Moderna are expected each week in the United States and J&J vaccines makes up less than 5% of vaccines administered in the country.

Approximately 13 million J&J doses are available to order or are already at administration sites, she said.

But much more is unknown, she said.

“There may be more cases identified in the coming days to weeks,” Dr. Oliver said, referring back to the average time from vaccination to symptom onset.

Scott Ratzan, MD, editor-in-chief of the Journal of Health Communication: International Perspectives and executive director of Business Partners to CONVINCE (BP2C), a global network of employers that promotes COVID-19 vaccination among employees, suppliers, and customers, applauded ACIP’s delay on making a decision.

Dr. Ratzan, who watched the deliberations online, said in an interview the decision “shows an admirable abundance of caution in the distribution of COVID-19 vaccines.”

“Unfortunately,” he said, “the pause also worsens the existing and pervasive vaccine hesitancy issue.

“We need a rational strategy regarding who should or should not get the J&J/Janssen vaccine since these rare adverse events appear to affect a particular group of people, females aged 18-48. It is essential that we build vaccine confidence and retain the option of using this vaccine for people who are not in this risk group.”

He pointed out there are safety red flags with the Pfizer and Moderna COVID-19 vaccines.

“We should feel reassured about the process of ensuring vaccine safety as the FDA and CDC have quickly addressed risk and shared the data transparently of the J&J vaccine and taken appropriate action,” he said.

ACIP’s executive secretary, Amanda Cohn, MD, said the date for the next meeting would be set by April 16.

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

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The recommended pause in use of the Johnson & Johnson COVID-19 vaccine will last at least another week after a Centers for Disease Control and Prevention advisory committee on April 14 decided not to take action.

Johnson &amp; Johnson

The Advisory Committee on Immunization Practices decided there was not adequate information to change again recommend use of the Johnson & Johnson vaccine.

The committee’s decision comes the day after the CDC and Food and Drug Administration recommended that J&J injections be paused after reports of rare, but serious types of blood clots in six patients among the 6.8 million people who had received the J&J vaccine in the United States.

A member of the committee, Beth Bell, MD, said: “I do not want to be sending a message that there is some huge concern here on a different order of magnitude than any other vaccine safety signals that we evaluate. And I don’t want to send a message that there is something fundamentally wrong with the vaccine because that also I don’t agree with.”

At the end of the 4-hour meeting, ACIP members decided to call a meeting in 1 or 2 weeks and evaluate more safety data, specifically reports of people who have received the J&J vaccine in the past 2 weeks.

Some, however, pointed out that delaying a decision could have substantial consequences as well in terms of unused vaccine doses and public confidence.

Committee member Camiile Kotton, MD, described the pause as “devastating.”

“Putting this vaccine on pause for those of us that are frontline health care workers has really been devastating,” she said. “I agree in general that we don’t have enough data to make a decision at this time but we were planning on using this vaccine in the state of Massachusetts for people who were homebound and otherwise not able to get a vaccine. We were planning on using it for our vulnerable inpatient population often with many comorbidities and at high risk for disease but haven’t been able to get vaccinated otherwise.”

Pausing the one-and-done vaccine that doesn’t have the significant refrigeration requirements of the others “is a significant loss,” she said.
 

What is known, not known

Sara Oliver, MD, who leads the COVID-19 Vaccines ACIP Work Group, summarized what is known and unknown about the blood clots.

Among the six cases of cerebral venous sinus thrombosis reported to the Vaccine Adverse Event Reporting System after the J&J shot, all were women aged 18-48 years and all developed the clots 6-13 days after receiving the vaccine.

No cases of these clots have been reported from either the Pfizer or Moderna shots, she noted.

In the United States, the two mRNA vaccine alternatives – the Moderna and Pfizer vaccines – are available “and based on current projections supply of both vaccines are expected to be relatively stable in the near future,” she said.

She said 14 million doses of Pfizer and Moderna are expected each week in the United States and J&J vaccines makes up less than 5% of vaccines administered in the country.

Approximately 13 million J&J doses are available to order or are already at administration sites, she said.

But much more is unknown, she said.

“There may be more cases identified in the coming days to weeks,” Dr. Oliver said, referring back to the average time from vaccination to symptom onset.

Scott Ratzan, MD, editor-in-chief of the Journal of Health Communication: International Perspectives and executive director of Business Partners to CONVINCE (BP2C), a global network of employers that promotes COVID-19 vaccination among employees, suppliers, and customers, applauded ACIP’s delay on making a decision.

Dr. Ratzan, who watched the deliberations online, said in an interview the decision “shows an admirable abundance of caution in the distribution of COVID-19 vaccines.”

“Unfortunately,” he said, “the pause also worsens the existing and pervasive vaccine hesitancy issue.

“We need a rational strategy regarding who should or should not get the J&J/Janssen vaccine since these rare adverse events appear to affect a particular group of people, females aged 18-48. It is essential that we build vaccine confidence and retain the option of using this vaccine for people who are not in this risk group.”

He pointed out there are safety red flags with the Pfizer and Moderna COVID-19 vaccines.

“We should feel reassured about the process of ensuring vaccine safety as the FDA and CDC have quickly addressed risk and shared the data transparently of the J&J vaccine and taken appropriate action,” he said.

ACIP’s executive secretary, Amanda Cohn, MD, said the date for the next meeting would be set by April 16.

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

The recommended pause in use of the Johnson & Johnson COVID-19 vaccine will last at least another week after a Centers for Disease Control and Prevention advisory committee on April 14 decided not to take action.

Johnson &amp; Johnson

The Advisory Committee on Immunization Practices decided there was not adequate information to change again recommend use of the Johnson & Johnson vaccine.

The committee’s decision comes the day after the CDC and Food and Drug Administration recommended that J&J injections be paused after reports of rare, but serious types of blood clots in six patients among the 6.8 million people who had received the J&J vaccine in the United States.

A member of the committee, Beth Bell, MD, said: “I do not want to be sending a message that there is some huge concern here on a different order of magnitude than any other vaccine safety signals that we evaluate. And I don’t want to send a message that there is something fundamentally wrong with the vaccine because that also I don’t agree with.”

At the end of the 4-hour meeting, ACIP members decided to call a meeting in 1 or 2 weeks and evaluate more safety data, specifically reports of people who have received the J&J vaccine in the past 2 weeks.

Some, however, pointed out that delaying a decision could have substantial consequences as well in terms of unused vaccine doses and public confidence.

Committee member Camiile Kotton, MD, described the pause as “devastating.”

“Putting this vaccine on pause for those of us that are frontline health care workers has really been devastating,” she said. “I agree in general that we don’t have enough data to make a decision at this time but we were planning on using this vaccine in the state of Massachusetts for people who were homebound and otherwise not able to get a vaccine. We were planning on using it for our vulnerable inpatient population often with many comorbidities and at high risk for disease but haven’t been able to get vaccinated otherwise.”

Pausing the one-and-done vaccine that doesn’t have the significant refrigeration requirements of the others “is a significant loss,” she said.
 

What is known, not known

Sara Oliver, MD, who leads the COVID-19 Vaccines ACIP Work Group, summarized what is known and unknown about the blood clots.

Among the six cases of cerebral venous sinus thrombosis reported to the Vaccine Adverse Event Reporting System after the J&J shot, all were women aged 18-48 years and all developed the clots 6-13 days after receiving the vaccine.

No cases of these clots have been reported from either the Pfizer or Moderna shots, she noted.

In the United States, the two mRNA vaccine alternatives – the Moderna and Pfizer vaccines – are available “and based on current projections supply of both vaccines are expected to be relatively stable in the near future,” she said.

She said 14 million doses of Pfizer and Moderna are expected each week in the United States and J&J vaccines makes up less than 5% of vaccines administered in the country.

Approximately 13 million J&J doses are available to order or are already at administration sites, she said.

But much more is unknown, she said.

“There may be more cases identified in the coming days to weeks,” Dr. Oliver said, referring back to the average time from vaccination to symptom onset.

Scott Ratzan, MD, editor-in-chief of the Journal of Health Communication: International Perspectives and executive director of Business Partners to CONVINCE (BP2C), a global network of employers that promotes COVID-19 vaccination among employees, suppliers, and customers, applauded ACIP’s delay on making a decision.

Dr. Ratzan, who watched the deliberations online, said in an interview the decision “shows an admirable abundance of caution in the distribution of COVID-19 vaccines.”

“Unfortunately,” he said, “the pause also worsens the existing and pervasive vaccine hesitancy issue.

“We need a rational strategy regarding who should or should not get the J&J/Janssen vaccine since these rare adverse events appear to affect a particular group of people, females aged 18-48. It is essential that we build vaccine confidence and retain the option of using this vaccine for people who are not in this risk group.”

He pointed out there are safety red flags with the Pfizer and Moderna COVID-19 vaccines.

“We should feel reassured about the process of ensuring vaccine safety as the FDA and CDC have quickly addressed risk and shared the data transparently of the J&J vaccine and taken appropriate action,” he said.

ACIP’s executive secretary, Amanda Cohn, MD, said the date for the next meeting would be set by April 16.

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

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