User login
Company submits supplemental NDA for topical atopic dermatitis treatment
in adults and children aged 6 years and older.
Roflumilast cream 0.3% (Zoryve) is currently approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Submission of the sNDA is based on positive results from the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once daily for 4 weeks to individuals 6 years of age and older with mild to moderate AD involving at least 3% body surface area. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor.
According to a press release from Arcutis, both studies met the primary endpoint of IGA Success, which was defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. In INTEGUMENT-1 this endpoint was achieved by 32.0% of subjects in the roflumilast cream group vs. 15.2% of those in the vehicle group (P < .0001). In INTEGUMENT-2, this endpoint was achieved by 28.9% of subjects in the roflumilast cream group vs. 12.0% of those in the vehicle group (P < .0001). The most common adverse reactions based on data from the combined trials were headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).
in adults and children aged 6 years and older.
Roflumilast cream 0.3% (Zoryve) is currently approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Submission of the sNDA is based on positive results from the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once daily for 4 weeks to individuals 6 years of age and older with mild to moderate AD involving at least 3% body surface area. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor.
According to a press release from Arcutis, both studies met the primary endpoint of IGA Success, which was defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. In INTEGUMENT-1 this endpoint was achieved by 32.0% of subjects in the roflumilast cream group vs. 15.2% of those in the vehicle group (P < .0001). In INTEGUMENT-2, this endpoint was achieved by 28.9% of subjects in the roflumilast cream group vs. 12.0% of those in the vehicle group (P < .0001). The most common adverse reactions based on data from the combined trials were headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).
in adults and children aged 6 years and older.
Roflumilast cream 0.3% (Zoryve) is currently approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Submission of the sNDA is based on positive results from the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once daily for 4 weeks to individuals 6 years of age and older with mild to moderate AD involving at least 3% body surface area. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor.
According to a press release from Arcutis, both studies met the primary endpoint of IGA Success, which was defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. In INTEGUMENT-1 this endpoint was achieved by 32.0% of subjects in the roflumilast cream group vs. 15.2% of those in the vehicle group (P < .0001). In INTEGUMENT-2, this endpoint was achieved by 28.9% of subjects in the roflumilast cream group vs. 12.0% of those in the vehicle group (P < .0001). The most common adverse reactions based on data from the combined trials were headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).
RSV season has started, and this year could be different
The Centers for Disease Control and Prevention issued a national alert to health officials Sept. 5, urging them to offer new medicines that can prevent severe cases of the respiratory virus in very young children and in older people. Those two groups are at the highest risk of potentially deadly complications from RSV.
Typically, the CDC considers the start of RSV season to occur when the rate of positive tests for the virus goes above 3% for 2 consecutive weeks. In Florida, the rate has been around 5% in recent weeks, and in Georgia, there has been an increase in RSV-related hospitalizations. Most of the hospitalizations in Georgia have been among infants less than a year old.
“Historically, such regional increases have predicted the beginning of RSV season nationally, with increased RSV activity spreading north and west over the following 2-3 months,” the CDC said.
Most children have been infected with RSV by the time they are 2 years old. Historically, up to 80,000 children under 5 years old are hospitalized annually because of the virus, and between 100 and 300 die from complications each year.
Those figures could be drastically different this year because new preventive treatments are available.
The CDC recommends that all children under 8 months old receive the newly approved monoclonal antibody treatment nirsevimab (Beyfortus). Children up to 19 months old at high risk of severe complications from RSV are also eligible for the single-dose shot. In clinical trials, the treatment was 80% effective at preventing RSV infections from becoming so severe that children had to be hospitalized. The protection lasted about 5 months.
Older people are also at a heightened risk of severe illness from RSV, and two new vaccines are available this season. The vaccines are called Arexvy and Abrysvo, and the single-dose shots are approved for people ages 60 years and older. They are more than 80% effective at making severe lower respiratory complications less likely.
Last year’s RSV season started during the summer and peaked in October and November, which was earlier than usual. There’s no indication yet of when RSV season may peak this year. Last year and throughout the pandemic, RSV held its historical pattern of starting in Florida.
A version of this article appeared on WebMD.com.
The Centers for Disease Control and Prevention issued a national alert to health officials Sept. 5, urging them to offer new medicines that can prevent severe cases of the respiratory virus in very young children and in older people. Those two groups are at the highest risk of potentially deadly complications from RSV.
Typically, the CDC considers the start of RSV season to occur when the rate of positive tests for the virus goes above 3% for 2 consecutive weeks. In Florida, the rate has been around 5% in recent weeks, and in Georgia, there has been an increase in RSV-related hospitalizations. Most of the hospitalizations in Georgia have been among infants less than a year old.
“Historically, such regional increases have predicted the beginning of RSV season nationally, with increased RSV activity spreading north and west over the following 2-3 months,” the CDC said.
Most children have been infected with RSV by the time they are 2 years old. Historically, up to 80,000 children under 5 years old are hospitalized annually because of the virus, and between 100 and 300 die from complications each year.
Those figures could be drastically different this year because new preventive treatments are available.
The CDC recommends that all children under 8 months old receive the newly approved monoclonal antibody treatment nirsevimab (Beyfortus). Children up to 19 months old at high risk of severe complications from RSV are also eligible for the single-dose shot. In clinical trials, the treatment was 80% effective at preventing RSV infections from becoming so severe that children had to be hospitalized. The protection lasted about 5 months.
Older people are also at a heightened risk of severe illness from RSV, and two new vaccines are available this season. The vaccines are called Arexvy and Abrysvo, and the single-dose shots are approved for people ages 60 years and older. They are more than 80% effective at making severe lower respiratory complications less likely.
Last year’s RSV season started during the summer and peaked in October and November, which was earlier than usual. There’s no indication yet of when RSV season may peak this year. Last year and throughout the pandemic, RSV held its historical pattern of starting in Florida.
A version of this article appeared on WebMD.com.
The Centers for Disease Control and Prevention issued a national alert to health officials Sept. 5, urging them to offer new medicines that can prevent severe cases of the respiratory virus in very young children and in older people. Those two groups are at the highest risk of potentially deadly complications from RSV.
Typically, the CDC considers the start of RSV season to occur when the rate of positive tests for the virus goes above 3% for 2 consecutive weeks. In Florida, the rate has been around 5% in recent weeks, and in Georgia, there has been an increase in RSV-related hospitalizations. Most of the hospitalizations in Georgia have been among infants less than a year old.
“Historically, such regional increases have predicted the beginning of RSV season nationally, with increased RSV activity spreading north and west over the following 2-3 months,” the CDC said.
Most children have been infected with RSV by the time they are 2 years old. Historically, up to 80,000 children under 5 years old are hospitalized annually because of the virus, and between 100 and 300 die from complications each year.
Those figures could be drastically different this year because new preventive treatments are available.
The CDC recommends that all children under 8 months old receive the newly approved monoclonal antibody treatment nirsevimab (Beyfortus). Children up to 19 months old at high risk of severe complications from RSV are also eligible for the single-dose shot. In clinical trials, the treatment was 80% effective at preventing RSV infections from becoming so severe that children had to be hospitalized. The protection lasted about 5 months.
Older people are also at a heightened risk of severe illness from RSV, and two new vaccines are available this season. The vaccines are called Arexvy and Abrysvo, and the single-dose shots are approved for people ages 60 years and older. They are more than 80% effective at making severe lower respiratory complications less likely.
Last year’s RSV season started during the summer and peaked in October and November, which was earlier than usual. There’s no indication yet of when RSV season may peak this year. Last year and throughout the pandemic, RSV held its historical pattern of starting in Florida.
A version of this article appeared on WebMD.com.
3D-printed meds customize the exact dose for sick children
Convincing kids to take their medicine could become much easier. Researchers at Texas A&M University are developing a new method of pharmaceutical 3D printing with pediatric patients in mind.
They hope to print precisely dosed tablets in child-friendly shapes and flavors. While the effort is focused on two drugs for pediatric AIDS, the process could be used to print other medicines, including for adults.
Researchers from Britain, Australia, and the University of Texas at Austin are also in the early stages of 3D-printed medication projects. It’s a promising venture in the broader pursuit of “personalized medicine,” tailoring treatments to each patient’s unique needs.
Drug mass production fails to address pediatric patients, who often need different dosages and combinations of medicines as they grow. As a result, adult tablets are often crushed and dissolved in liquid – known as compounding – and given to children. But this can harm drug quality and make doses less precise.
“Suppose the child needs 3.4 milligrams and only a 10-milligram tablet is available. Once you manipulate the dosage from solid to liquid, how do you ensure that it has the same amount of drug in it?” said co-principal investigator Mansoor Khan, PhD, a professor of pharmaceutical sciences at Texas A&M.
Most pharmacies lack the equipment to test compounded drug quality, he said. And liquified drugs taste bad because the pill coating has been ground away.
“Flavor is a big issue,” said Olive Eckstein, MD, an assistant professor of pediatric hematology-oncology at Texas Children’s Hospital and Baylor College of Medicine, who is not involved in the research. “Hospitals will sometimes delay discharging pediatric patients because they can’t take their meds orally and have to get an IV formulation.”
Updating pharmaceutical 3D printing
The FDA approved a 3D-printed drug in 2015, but since then, progress has stalled, largely because the method relied on solvents to bind drug particles together. Over time, solvents can compromise shelf life, according to co-principal investigator Mathew Kuttolamadom, PhD, an associate professor of engineering at Texas A&M.
The Texas A&M team is using a different method, without solvents. First, they create a powder mixture of the drug, a biocompatible polymer (such as lactose), and a sheen, a pigment that colors the tablet and allows heat to be absorbed. Flavoring can also be added. Next, the mixture is heated in the printer chamber.
“The polymer should melt just enough. That gives the tablet structural strength. But it should not melt too much, whereby the drug can start dissolving into the polymer,” Dr. Kuttolamadom said.
The tablets are finished with precise applications of laser heat. Using computer-aided design software, the researchers can create tablets in almost any shape, such as “stars or teddy bears,” he said.
After much trial and error, the researchers have printed tablets that won’t break apart or become soggy.
Now they are testing how different laser scan speeds affect the structure of the tablet, which in turn affects the rate at which drugs dissolve. Slowing down the laser imparts more energy, strengthening the tablet structure and making drugs dissolve slower, for a longer release inside the body.
The researchers hope to develop machine learning models to test different laser speed combinations. Eventually, they could create tablets that combine drugs with different dissolve rates.
“The outside could be a rapid release, and the inside could be an extended release or a sustained release, or even a completely different drug,” Dr. Kuttolamadom said.
Older patients who take many daily medications could benefit from the technology. “Personalized tablets could be printed at your local pharmacy,” he said, “even before you leave your doctor’s office.”
A version of this article first appeared on WebMD.com.
Convincing kids to take their medicine could become much easier. Researchers at Texas A&M University are developing a new method of pharmaceutical 3D printing with pediatric patients in mind.
They hope to print precisely dosed tablets in child-friendly shapes and flavors. While the effort is focused on two drugs for pediatric AIDS, the process could be used to print other medicines, including for adults.
Researchers from Britain, Australia, and the University of Texas at Austin are also in the early stages of 3D-printed medication projects. It’s a promising venture in the broader pursuit of “personalized medicine,” tailoring treatments to each patient’s unique needs.
Drug mass production fails to address pediatric patients, who often need different dosages and combinations of medicines as they grow. As a result, adult tablets are often crushed and dissolved in liquid – known as compounding – and given to children. But this can harm drug quality and make doses less precise.
“Suppose the child needs 3.4 milligrams and only a 10-milligram tablet is available. Once you manipulate the dosage from solid to liquid, how do you ensure that it has the same amount of drug in it?” said co-principal investigator Mansoor Khan, PhD, a professor of pharmaceutical sciences at Texas A&M.
Most pharmacies lack the equipment to test compounded drug quality, he said. And liquified drugs taste bad because the pill coating has been ground away.
“Flavor is a big issue,” said Olive Eckstein, MD, an assistant professor of pediatric hematology-oncology at Texas Children’s Hospital and Baylor College of Medicine, who is not involved in the research. “Hospitals will sometimes delay discharging pediatric patients because they can’t take their meds orally and have to get an IV formulation.”
Updating pharmaceutical 3D printing
The FDA approved a 3D-printed drug in 2015, but since then, progress has stalled, largely because the method relied on solvents to bind drug particles together. Over time, solvents can compromise shelf life, according to co-principal investigator Mathew Kuttolamadom, PhD, an associate professor of engineering at Texas A&M.
The Texas A&M team is using a different method, without solvents. First, they create a powder mixture of the drug, a biocompatible polymer (such as lactose), and a sheen, a pigment that colors the tablet and allows heat to be absorbed. Flavoring can also be added. Next, the mixture is heated in the printer chamber.
“The polymer should melt just enough. That gives the tablet structural strength. But it should not melt too much, whereby the drug can start dissolving into the polymer,” Dr. Kuttolamadom said.
The tablets are finished with precise applications of laser heat. Using computer-aided design software, the researchers can create tablets in almost any shape, such as “stars or teddy bears,” he said.
After much trial and error, the researchers have printed tablets that won’t break apart or become soggy.
Now they are testing how different laser scan speeds affect the structure of the tablet, which in turn affects the rate at which drugs dissolve. Slowing down the laser imparts more energy, strengthening the tablet structure and making drugs dissolve slower, for a longer release inside the body.
The researchers hope to develop machine learning models to test different laser speed combinations. Eventually, they could create tablets that combine drugs with different dissolve rates.
“The outside could be a rapid release, and the inside could be an extended release or a sustained release, or even a completely different drug,” Dr. Kuttolamadom said.
Older patients who take many daily medications could benefit from the technology. “Personalized tablets could be printed at your local pharmacy,” he said, “even before you leave your doctor’s office.”
A version of this article first appeared on WebMD.com.
Convincing kids to take their medicine could become much easier. Researchers at Texas A&M University are developing a new method of pharmaceutical 3D printing with pediatric patients in mind.
They hope to print precisely dosed tablets in child-friendly shapes and flavors. While the effort is focused on two drugs for pediatric AIDS, the process could be used to print other medicines, including for adults.
Researchers from Britain, Australia, and the University of Texas at Austin are also in the early stages of 3D-printed medication projects. It’s a promising venture in the broader pursuit of “personalized medicine,” tailoring treatments to each patient’s unique needs.
Drug mass production fails to address pediatric patients, who often need different dosages and combinations of medicines as they grow. As a result, adult tablets are often crushed and dissolved in liquid – known as compounding – and given to children. But this can harm drug quality and make doses less precise.
“Suppose the child needs 3.4 milligrams and only a 10-milligram tablet is available. Once you manipulate the dosage from solid to liquid, how do you ensure that it has the same amount of drug in it?” said co-principal investigator Mansoor Khan, PhD, a professor of pharmaceutical sciences at Texas A&M.
Most pharmacies lack the equipment to test compounded drug quality, he said. And liquified drugs taste bad because the pill coating has been ground away.
“Flavor is a big issue,” said Olive Eckstein, MD, an assistant professor of pediatric hematology-oncology at Texas Children’s Hospital and Baylor College of Medicine, who is not involved in the research. “Hospitals will sometimes delay discharging pediatric patients because they can’t take their meds orally and have to get an IV formulation.”
Updating pharmaceutical 3D printing
The FDA approved a 3D-printed drug in 2015, but since then, progress has stalled, largely because the method relied on solvents to bind drug particles together. Over time, solvents can compromise shelf life, according to co-principal investigator Mathew Kuttolamadom, PhD, an associate professor of engineering at Texas A&M.
The Texas A&M team is using a different method, without solvents. First, they create a powder mixture of the drug, a biocompatible polymer (such as lactose), and a sheen, a pigment that colors the tablet and allows heat to be absorbed. Flavoring can also be added. Next, the mixture is heated in the printer chamber.
“The polymer should melt just enough. That gives the tablet structural strength. But it should not melt too much, whereby the drug can start dissolving into the polymer,” Dr. Kuttolamadom said.
The tablets are finished with precise applications of laser heat. Using computer-aided design software, the researchers can create tablets in almost any shape, such as “stars or teddy bears,” he said.
After much trial and error, the researchers have printed tablets that won’t break apart or become soggy.
Now they are testing how different laser scan speeds affect the structure of the tablet, which in turn affects the rate at which drugs dissolve. Slowing down the laser imparts more energy, strengthening the tablet structure and making drugs dissolve slower, for a longer release inside the body.
The researchers hope to develop machine learning models to test different laser speed combinations. Eventually, they could create tablets that combine drugs with different dissolve rates.
“The outside could be a rapid release, and the inside could be an extended release or a sustained release, or even a completely different drug,” Dr. Kuttolamadom said.
Older patients who take many daily medications could benefit from the technology. “Personalized tablets could be printed at your local pharmacy,” he said, “even before you leave your doctor’s office.”
A version of this article first appeared on WebMD.com.
ESC issues first comprehensive cardiomyopathy guidelines
The European Society of Cardiology has released new guidelines for cardiomyopathies, their first major comprehensive international guidelines to address diagnosis and treatment of the broad causes of heart muscle dysfunction.
The document was released in conjunction with the annual congress of the European Society of Cardiology and is also available online in the European Heart Journal.
“We have considered cardiomyopathies across the life course from pediatric to adult,” explained Elena Arbelo, MD, PhD, coordinator of the cardiac genetic diseases and sudden arrhythmic death unit, Hospital Clinic de Barcelona. Dr. Arbelo is first author and one of two chairpersons of the ESC task force that brought the guidelines forward.
Not an update, Dr. Arbelo said.
Guidelines organize cardiomyopathy phenotypes
Cardiomyopathy can present at any age. It can have multiple complex etiologies, including genetic predisposition, heart muscle injury caused by disease, or a mix of participating factors. The ESC task force employed several strategies in taking a comprehensive approach to the condition, said Juan Kaski, MD, PhD, professor of pediatric inherited cardiovascular medicine at the University College of London.
“From my point of view, the key innovations include a diagnostic workup that starts with a detailed phenotypic description, including the new phenotype of nondilated left ventricular cardiomyopathy, that then triggers a multiparametric, systematic evaluation,” said Dr. Kaski, cochair of the task force.
As explained in the introduction to the guideline and reiterated by both Dr. Arbelo and Dr. Kaski, the guidelines have been organized around the patient pathway, meaning that focus should be placed on recognizing the presenting phenotype as a critical first step in discerning the underlying etiology and its treatments.
“Central to this approach is not only the individual patient but also the family as a whole,” Dr. Arbelo said. “Clinical findings in relatives are essential for understanding what happens to the patient and vice versa.”
Genetic testing in children described
The new guidelines include specific recommendations about genetic testing of children. They also emphasize the value of cardiovascular magnetic resonance (CMR) imaging in the “diagnosis, screening, monitoring, and prognostication” for patients of all ages, according to Dr. Kaski.
“CMR is recommended at the initial evaluation for every patient with cardiomyopathy,” Dr. Arbelo said. It should be “considered” during follow-up and for many other applications, including the evaluation of “genotype-positive but phenotype-negative relatives.”
Etiologic prediction models have been incorporated into the guidelines, including genotyping for dilated cardiomyopathies and nondilated left ventricular cardiomyopathy, said both Dr. Arbelo and Dr. Kaski, interviewed separately. They both indicated that the task force did their best to make the guidelines user friendly.
Each of the recommendations in the guidelines is provided with an evidence-based classification. In order, these are class I (recommended), class IIa (should be considered), class IIb (may be considered), and class III (not recommended).
Many symptoms are cardiomyopathy related
Dr. Kaski and Dr. Arbelo both emphasized that the guidelines draw attention to the relationship of cardiomyopathy to common cardiovascular conditions, such as heart failure, arrhythmia, and chest pain. Dr. Kaski pointed out that these are the types of problems commonly encountered by general cardiologists and well as primary care physicians.
In 2014, the ESC published guidelines specific to HCM. The new broader guidelines do not overlook this subtype. According to Dr. Kaski, there have been several innovations in HCM since the previous guidelines, such as when to consider cardiac myosin inhibitors for symptomatic left ventricular outflow tract obstruction.
The ESC guidelines place an emphasis on a “coordinated, systematic, and individualized” care pathway based on a multidisciplinary approach, according to Dr. Arbelo. Although the composition of the interdisciplinary team depends on the individual case, the guidelines recognize a key role for general cardiologists in managing the majority of patients. Suggestions of when to refer challenging cases to expert centers are outlined.
32 key messages derived from guidelines
The guidelines include almost 90 pages of recommendations. The task force isolated 32 key messages from 13 sections ranging from descriptions of how the patient pathway is defined to what types of physical activity should be considered for different forms of cardiomyopathy. There is also a section devoted to important gaps in evidence and areas in which there is the most need for further studies.
The guidelines end with a comprehensive list of “what to do” and “what not to do” in the diagnosis and care of cardiomyopathy. These include most of the class I recommendations and summarize some important class III cautions.
“Most of the recommendations in the guideline are new,” the authors wrote in the introduction. Although they acknowledged that they did not attempt to provide detailed recommendations for every cardiomyopathy phenotype, they endeavored to cover general evaluation and management issues supported by relevant evidence.
Dr. Arbelo and Dr. Kaski disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The European Society of Cardiology has released new guidelines for cardiomyopathies, their first major comprehensive international guidelines to address diagnosis and treatment of the broad causes of heart muscle dysfunction.
The document was released in conjunction with the annual congress of the European Society of Cardiology and is also available online in the European Heart Journal.
“We have considered cardiomyopathies across the life course from pediatric to adult,” explained Elena Arbelo, MD, PhD, coordinator of the cardiac genetic diseases and sudden arrhythmic death unit, Hospital Clinic de Barcelona. Dr. Arbelo is first author and one of two chairpersons of the ESC task force that brought the guidelines forward.
Not an update, Dr. Arbelo said.
Guidelines organize cardiomyopathy phenotypes
Cardiomyopathy can present at any age. It can have multiple complex etiologies, including genetic predisposition, heart muscle injury caused by disease, or a mix of participating factors. The ESC task force employed several strategies in taking a comprehensive approach to the condition, said Juan Kaski, MD, PhD, professor of pediatric inherited cardiovascular medicine at the University College of London.
“From my point of view, the key innovations include a diagnostic workup that starts with a detailed phenotypic description, including the new phenotype of nondilated left ventricular cardiomyopathy, that then triggers a multiparametric, systematic evaluation,” said Dr. Kaski, cochair of the task force.
As explained in the introduction to the guideline and reiterated by both Dr. Arbelo and Dr. Kaski, the guidelines have been organized around the patient pathway, meaning that focus should be placed on recognizing the presenting phenotype as a critical first step in discerning the underlying etiology and its treatments.
“Central to this approach is not only the individual patient but also the family as a whole,” Dr. Arbelo said. “Clinical findings in relatives are essential for understanding what happens to the patient and vice versa.”
Genetic testing in children described
The new guidelines include specific recommendations about genetic testing of children. They also emphasize the value of cardiovascular magnetic resonance (CMR) imaging in the “diagnosis, screening, monitoring, and prognostication” for patients of all ages, according to Dr. Kaski.
“CMR is recommended at the initial evaluation for every patient with cardiomyopathy,” Dr. Arbelo said. It should be “considered” during follow-up and for many other applications, including the evaluation of “genotype-positive but phenotype-negative relatives.”
Etiologic prediction models have been incorporated into the guidelines, including genotyping for dilated cardiomyopathies and nondilated left ventricular cardiomyopathy, said both Dr. Arbelo and Dr. Kaski, interviewed separately. They both indicated that the task force did their best to make the guidelines user friendly.
Each of the recommendations in the guidelines is provided with an evidence-based classification. In order, these are class I (recommended), class IIa (should be considered), class IIb (may be considered), and class III (not recommended).
Many symptoms are cardiomyopathy related
Dr. Kaski and Dr. Arbelo both emphasized that the guidelines draw attention to the relationship of cardiomyopathy to common cardiovascular conditions, such as heart failure, arrhythmia, and chest pain. Dr. Kaski pointed out that these are the types of problems commonly encountered by general cardiologists and well as primary care physicians.
In 2014, the ESC published guidelines specific to HCM. The new broader guidelines do not overlook this subtype. According to Dr. Kaski, there have been several innovations in HCM since the previous guidelines, such as when to consider cardiac myosin inhibitors for symptomatic left ventricular outflow tract obstruction.
The ESC guidelines place an emphasis on a “coordinated, systematic, and individualized” care pathway based on a multidisciplinary approach, according to Dr. Arbelo. Although the composition of the interdisciplinary team depends on the individual case, the guidelines recognize a key role for general cardiologists in managing the majority of patients. Suggestions of when to refer challenging cases to expert centers are outlined.
32 key messages derived from guidelines
The guidelines include almost 90 pages of recommendations. The task force isolated 32 key messages from 13 sections ranging from descriptions of how the patient pathway is defined to what types of physical activity should be considered for different forms of cardiomyopathy. There is also a section devoted to important gaps in evidence and areas in which there is the most need for further studies.
The guidelines end with a comprehensive list of “what to do” and “what not to do” in the diagnosis and care of cardiomyopathy. These include most of the class I recommendations and summarize some important class III cautions.
“Most of the recommendations in the guideline are new,” the authors wrote in the introduction. Although they acknowledged that they did not attempt to provide detailed recommendations for every cardiomyopathy phenotype, they endeavored to cover general evaluation and management issues supported by relevant evidence.
Dr. Arbelo and Dr. Kaski disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The European Society of Cardiology has released new guidelines for cardiomyopathies, their first major comprehensive international guidelines to address diagnosis and treatment of the broad causes of heart muscle dysfunction.
The document was released in conjunction with the annual congress of the European Society of Cardiology and is also available online in the European Heart Journal.
“We have considered cardiomyopathies across the life course from pediatric to adult,” explained Elena Arbelo, MD, PhD, coordinator of the cardiac genetic diseases and sudden arrhythmic death unit, Hospital Clinic de Barcelona. Dr. Arbelo is first author and one of two chairpersons of the ESC task force that brought the guidelines forward.
Not an update, Dr. Arbelo said.
Guidelines organize cardiomyopathy phenotypes
Cardiomyopathy can present at any age. It can have multiple complex etiologies, including genetic predisposition, heart muscle injury caused by disease, or a mix of participating factors. The ESC task force employed several strategies in taking a comprehensive approach to the condition, said Juan Kaski, MD, PhD, professor of pediatric inherited cardiovascular medicine at the University College of London.
“From my point of view, the key innovations include a diagnostic workup that starts with a detailed phenotypic description, including the new phenotype of nondilated left ventricular cardiomyopathy, that then triggers a multiparametric, systematic evaluation,” said Dr. Kaski, cochair of the task force.
As explained in the introduction to the guideline and reiterated by both Dr. Arbelo and Dr. Kaski, the guidelines have been organized around the patient pathway, meaning that focus should be placed on recognizing the presenting phenotype as a critical first step in discerning the underlying etiology and its treatments.
“Central to this approach is not only the individual patient but also the family as a whole,” Dr. Arbelo said. “Clinical findings in relatives are essential for understanding what happens to the patient and vice versa.”
Genetic testing in children described
The new guidelines include specific recommendations about genetic testing of children. They also emphasize the value of cardiovascular magnetic resonance (CMR) imaging in the “diagnosis, screening, monitoring, and prognostication” for patients of all ages, according to Dr. Kaski.
“CMR is recommended at the initial evaluation for every patient with cardiomyopathy,” Dr. Arbelo said. It should be “considered” during follow-up and for many other applications, including the evaluation of “genotype-positive but phenotype-negative relatives.”
Etiologic prediction models have been incorporated into the guidelines, including genotyping for dilated cardiomyopathies and nondilated left ventricular cardiomyopathy, said both Dr. Arbelo and Dr. Kaski, interviewed separately. They both indicated that the task force did their best to make the guidelines user friendly.
Each of the recommendations in the guidelines is provided with an evidence-based classification. In order, these are class I (recommended), class IIa (should be considered), class IIb (may be considered), and class III (not recommended).
Many symptoms are cardiomyopathy related
Dr. Kaski and Dr. Arbelo both emphasized that the guidelines draw attention to the relationship of cardiomyopathy to common cardiovascular conditions, such as heart failure, arrhythmia, and chest pain. Dr. Kaski pointed out that these are the types of problems commonly encountered by general cardiologists and well as primary care physicians.
In 2014, the ESC published guidelines specific to HCM. The new broader guidelines do not overlook this subtype. According to Dr. Kaski, there have been several innovations in HCM since the previous guidelines, such as when to consider cardiac myosin inhibitors for symptomatic left ventricular outflow tract obstruction.
The ESC guidelines place an emphasis on a “coordinated, systematic, and individualized” care pathway based on a multidisciplinary approach, according to Dr. Arbelo. Although the composition of the interdisciplinary team depends on the individual case, the guidelines recognize a key role for general cardiologists in managing the majority of patients. Suggestions of when to refer challenging cases to expert centers are outlined.
32 key messages derived from guidelines
The guidelines include almost 90 pages of recommendations. The task force isolated 32 key messages from 13 sections ranging from descriptions of how the patient pathway is defined to what types of physical activity should be considered for different forms of cardiomyopathy. There is also a section devoted to important gaps in evidence and areas in which there is the most need for further studies.
The guidelines end with a comprehensive list of “what to do” and “what not to do” in the diagnosis and care of cardiomyopathy. These include most of the class I recommendations and summarize some important class III cautions.
“Most of the recommendations in the guideline are new,” the authors wrote in the introduction. Although they acknowledged that they did not attempt to provide detailed recommendations for every cardiomyopathy phenotype, they endeavored to cover general evaluation and management issues supported by relevant evidence.
Dr. Arbelo and Dr. Kaski disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE ESC CONGRESS 2023
‘Decapitated’ boy saved by surgery team
This transcript has been edited for clarity.
F. Perry Wilson, MD, MSCE: I am joined today by Dr. Ohad Einav. He’s a staff surgeon in orthopedics at Hadassah Medical Center in Jerusalem. He’s with me to talk about an absolutely incredible surgical case, something that is terrifying to most non–orthopedic surgeons and I imagine is fairly scary for spine surgeons like him as well. But what we don’t have is information about how this works from a medical perspective. So, first of all, Dr. Einav, thank you for taking time to speak with me today.
Ohad Einav, MD: Thank you for having me.
Dr. Wilson: Can you tell us about Suleiman Hassan and what happened to him before he came into your care?
Dr. Einav: Hassan is a 12-year-old child who was riding his bicycle on the West Bank, about 40 minutes from here. Unfortunately, he was involved in a motor vehicle accident and he suffered injuries to his abdomen and cervical spine. He was transported to our service by helicopter from the scene of the accident.
Dr. Wilson: “Injury to the cervical spine” might be something of an understatement. He had what’s called atlanto-occipital dislocation, colloquially often referred to as internal decapitation. Can you tell us what that means? It sounds terrifying.
Dr. Einav: It’s an injury to the ligaments between the occiput and the upper cervical spine, with or without bony fracture. The atlanto-occipital joint is formed by the superior articular facet of the atlas and the occipital condyle, stabilized by an articular capsule between the head and neck, and is supported by various ligaments around it that stabilize the joint and allow joint movements, including flexion, extension, and some rotation in the lower levels.
Dr. Wilson: This joint has several degrees of freedom, which means it needs a lot of support. With this type of injury, where essentially you have severing of the ligaments, is it usually survivable? How dangerous is this?
Dr. Einav: The mortality rate is 50%-60%, depending on the primary impact, the injury, transportation later on, and then the surgery and surgical management.
Dr. Wilson: Tell us a bit about this patient’s status when he came to your medical center. I assume he was in bad shape.
Dr. Einav: Hassan arrived at our medical center with a Glasgow Coma Scale score of 15. He was fully conscious. He was hemodynamically stable except for a bad laceration on his abdomen. He had a Philadelphia collar around his neck. He was transported by chopper because the paramedics suspected that he had a cervical spine injury and decided to bring him to a Level 1 trauma center.
He was monitored and we treated him according to the ATLS [advanced trauma life support] protocol. He didn’t have any gross sensory deficits, but he was a little confused about the whole situation and the accident. Therefore, we could do a general examination but we couldn’t rely on that regarding any sensory deficit that he may or may not have. We decided as a team that it would be better to slow down and control the situation. We decided not to operate on him immediately. We basically stabilized him and made sure that he didn’t have any traumatic internal organ damage. Later on we took him to the OR and performed surgery.
Dr. Wilson: It’s amazing that he had intact motor function, considering the extent of his injury. The spinal cord was spared somewhat during the injury. There must have been a moment when you realized that this kid, who was conscious and could move all four extremities, had a very severe neck injury. Was that due to a CT scan or physical exam? And what was your feeling when you saw that he had atlanto-occipital dislocation?
Dr. Einav: As a surgeon, you have a gut feeling in regard to the general examination of the patient. But I never rely on gut feelings. On the CT, I understood exactly what he had, what we needed to do, and the time frame.
Dr. Wilson: You’ve done these types of surgeries before, right? Obviously, no one has done a lot of them because this isn’t very common. But you knew what to do. Did you have a plan? Where does your experience come into play in a situation like this?
Dr. Einav: I graduated from the spine program of Toronto University, where I did a fellowship in trauma of the spine and complex spine surgery. I had very good teachers, and during my fellowship I treated a few cases in older patients that were similar but not the same. Therefore, I knew exactly what needed to be done.
Dr. Wilson: For those of us who aren’t surgeons, take us into the OR with you. This is obviously an incredibly delicate procedure. You are high up in the spinal cord at the base of the brain. The slightest mistake could have devastating consequences. What are the key elements of this procedure? What can go wrong here? What is the number-one thing you have to look out for when you’re trying to fix an internal decapitation?
Dr. Einav: The key element in surgeries of the cervical spine – trauma and complex spine surgery – is planning. I never go to the OR without knowing what I’m going to do. I have a few plans – plan A, plan B, plan C – in case something fails. So, I definitely know what the next step will be. I always think about the surgery a few hours before, if I have time to prepare.
The second thing that is very important is teamwork. The team needs to be coordinated. Everybody needs to know what their job is. With these types of injuries, it’s not the time for rookies. If you are new, please stand back and let the more experienced people do that job. I’m talking about surgeons, nurses, anesthesiologists – everyone.
Another important thing in planning is choosing the right hardware. For example, in this case we had a problem because most of the hardware is designed for adults, and we had to improvise because there isn’t a lot of hardware on the market for the pediatric population. The adult plates and screws are too big, so we had to improvise.
Dr. Wilson: Tell us more about that. How do you improvise spinal hardware for a 12-year-old?
Dr. Einav: In this case, I chose to use hardware from one of the companies that works with us.
You can see in this model the area of the injury, and the area that we worked on. To perform the surgery, I had to use some plates and rods from a different company. This company’s (NuVasive) hardware has a small attachment to the skull, which was helpful for affixing the skull to the cervical spine, instead of using a big plate that would sit at the base of the skull and would not be very good for him. Most of the hardware is made for adults and not for kids.
Dr. Wilson: Will that hardware preserve the motor function of his neck? Will he be able to turn his head and extend and flex it?
Dr. Einav: The injury leads to instability and destruction of both articulations between the head and neck. Therefore, those articulations won’t be able to function the same way in the future. There is a decrease of something like 50% of the flexion and extension of Hassan’s cervical spine. Therefore, I decided that in this case there would be no chance of saving Hassan’s motor function unless we performed a fusion between the head and the neck, and therefore I decided that this would be the best procedure with the best survival rate. So, in the future, he will have some diminished flexion, extension, and rotation of his head.
Dr. Wilson: How long did his surgery take?
Dr. Einav: To be honest, I don’t remember. But I can tell you that it took us time. It was very challenging to coordinate with everyone. The most problematic part of the surgery to perform is what we call “flip-over.”
The anesthesiologist intubated the patient when he was supine, and later on, we flipped him prone to operate on the spine. This maneuver can actually lead to injury by itself, and injury at this level is fatal. So, we took our time and got Hassan into the OR. The anesthesiologist did a great job with the GlideScope – inserting the endotracheal tube. Later on, we neuromonitored him. Basically, we connected Hassan’s peripheral nerves to a computer and monitored his motor function. Gently we flipped him over, and after that we saw a little change in his motor function, so we had to modify his position so we could preserve his motor function. We then started the procedure, which took a few hours. I don’t know exactly how many.
Dr. Wilson: That just speaks to how delicate this is for everything from the intubation, where typically you’re manipulating the head, to the repositioning. Clearly this requires a lot of teamwork.
What happened after the operation? How is he doing?
Dr. Einav: After the operation, Hassan had a great recovery. He’s doing well. He doesn’t have any motor or sensory deficits. He’s able to ambulate without any aid. He had no signs of infection, which can happen after a car accident, neither from his abdominal wound nor from the occipital cervical surgery. He feels well. We saw him in the clinic. We removed his collar. We monitored him at the clinic. He looked amazing.
Dr. Wilson: That’s incredible. Are there long-term risks for him that you need to be looking out for?
Dr. Einav: Yes, and that’s the reason that we are monitoring him post surgery. While he was in the hospital, we monitored his motor and sensory functions, as well as his wound healing. Later on, in the clinic, for a few weeks after surgery we monitored for any failure of the hardware and bone graft. We check for healing of the bone graft and bone substitutes we put in to heal those bones.
Dr. Wilson: He will grow, right? He’s only 12, so he still has some years of growth in him. Is he going to need more surgery or any kind of hardware upgrade?
Dr. Einav: I hope not. In my surgeries, I never rely on the hardware for long durations. If I decide to do, for example, fusion, I rely on the hardware for a certain amount of time. And then I plan that the biology will do the work. If I plan for fusion, I put bone grafts in the preferred area for a fusion. Then if the hardware fails, I wouldn’t need to take out the hardware, and there would be no change in the condition of the patient.
Dr. Wilson: What an incredible story. It’s clear that you and your team kept your cool despite a very high-acuity situation with a ton of risk. What a tremendous outcome that this boy is not only alive but fully functional. So, congratulations to you and your team. That was very strong work.
Dr. Einav: Thank you very much. I would like to thank our team. We have to remember that the surgeon is not standing alone in the war. Hassan’s story is a success story of a very big group of people from various backgrounds and religions. They work day and night to help people and save lives. To the paramedics, the physiologists, the traumatologists, the pediatricians, the nurses, the physiotherapists, and obviously the surgeons, a big thank you. His story is our success story.
Dr. Wilson: It’s inspiring to see so many people come together to do what we all are here for, which is to fight against suffering, disease, and death. Thank you for keeping up that fight. And thank you for joining me here.
Dr. Einav: Thank you very much.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
F. Perry Wilson, MD, MSCE: I am joined today by Dr. Ohad Einav. He’s a staff surgeon in orthopedics at Hadassah Medical Center in Jerusalem. He’s with me to talk about an absolutely incredible surgical case, something that is terrifying to most non–orthopedic surgeons and I imagine is fairly scary for spine surgeons like him as well. But what we don’t have is information about how this works from a medical perspective. So, first of all, Dr. Einav, thank you for taking time to speak with me today.
Ohad Einav, MD: Thank you for having me.
Dr. Wilson: Can you tell us about Suleiman Hassan and what happened to him before he came into your care?
Dr. Einav: Hassan is a 12-year-old child who was riding his bicycle on the West Bank, about 40 minutes from here. Unfortunately, he was involved in a motor vehicle accident and he suffered injuries to his abdomen and cervical spine. He was transported to our service by helicopter from the scene of the accident.
Dr. Wilson: “Injury to the cervical spine” might be something of an understatement. He had what’s called atlanto-occipital dislocation, colloquially often referred to as internal decapitation. Can you tell us what that means? It sounds terrifying.
Dr. Einav: It’s an injury to the ligaments between the occiput and the upper cervical spine, with or without bony fracture. The atlanto-occipital joint is formed by the superior articular facet of the atlas and the occipital condyle, stabilized by an articular capsule between the head and neck, and is supported by various ligaments around it that stabilize the joint and allow joint movements, including flexion, extension, and some rotation in the lower levels.
Dr. Wilson: This joint has several degrees of freedom, which means it needs a lot of support. With this type of injury, where essentially you have severing of the ligaments, is it usually survivable? How dangerous is this?
Dr. Einav: The mortality rate is 50%-60%, depending on the primary impact, the injury, transportation later on, and then the surgery and surgical management.
Dr. Wilson: Tell us a bit about this patient’s status when he came to your medical center. I assume he was in bad shape.
Dr. Einav: Hassan arrived at our medical center with a Glasgow Coma Scale score of 15. He was fully conscious. He was hemodynamically stable except for a bad laceration on his abdomen. He had a Philadelphia collar around his neck. He was transported by chopper because the paramedics suspected that he had a cervical spine injury and decided to bring him to a Level 1 trauma center.
He was monitored and we treated him according to the ATLS [advanced trauma life support] protocol. He didn’t have any gross sensory deficits, but he was a little confused about the whole situation and the accident. Therefore, we could do a general examination but we couldn’t rely on that regarding any sensory deficit that he may or may not have. We decided as a team that it would be better to slow down and control the situation. We decided not to operate on him immediately. We basically stabilized him and made sure that he didn’t have any traumatic internal organ damage. Later on we took him to the OR and performed surgery.
Dr. Wilson: It’s amazing that he had intact motor function, considering the extent of his injury. The spinal cord was spared somewhat during the injury. There must have been a moment when you realized that this kid, who was conscious and could move all four extremities, had a very severe neck injury. Was that due to a CT scan or physical exam? And what was your feeling when you saw that he had atlanto-occipital dislocation?
Dr. Einav: As a surgeon, you have a gut feeling in regard to the general examination of the patient. But I never rely on gut feelings. On the CT, I understood exactly what he had, what we needed to do, and the time frame.
Dr. Wilson: You’ve done these types of surgeries before, right? Obviously, no one has done a lot of them because this isn’t very common. But you knew what to do. Did you have a plan? Where does your experience come into play in a situation like this?
Dr. Einav: I graduated from the spine program of Toronto University, where I did a fellowship in trauma of the spine and complex spine surgery. I had very good teachers, and during my fellowship I treated a few cases in older patients that were similar but not the same. Therefore, I knew exactly what needed to be done.
Dr. Wilson: For those of us who aren’t surgeons, take us into the OR with you. This is obviously an incredibly delicate procedure. You are high up in the spinal cord at the base of the brain. The slightest mistake could have devastating consequences. What are the key elements of this procedure? What can go wrong here? What is the number-one thing you have to look out for when you’re trying to fix an internal decapitation?
Dr. Einav: The key element in surgeries of the cervical spine – trauma and complex spine surgery – is planning. I never go to the OR without knowing what I’m going to do. I have a few plans – plan A, plan B, plan C – in case something fails. So, I definitely know what the next step will be. I always think about the surgery a few hours before, if I have time to prepare.
The second thing that is very important is teamwork. The team needs to be coordinated. Everybody needs to know what their job is. With these types of injuries, it’s not the time for rookies. If you are new, please stand back and let the more experienced people do that job. I’m talking about surgeons, nurses, anesthesiologists – everyone.
Another important thing in planning is choosing the right hardware. For example, in this case we had a problem because most of the hardware is designed for adults, and we had to improvise because there isn’t a lot of hardware on the market for the pediatric population. The adult plates and screws are too big, so we had to improvise.
Dr. Wilson: Tell us more about that. How do you improvise spinal hardware for a 12-year-old?
Dr. Einav: In this case, I chose to use hardware from one of the companies that works with us.
You can see in this model the area of the injury, and the area that we worked on. To perform the surgery, I had to use some plates and rods from a different company. This company’s (NuVasive) hardware has a small attachment to the skull, which was helpful for affixing the skull to the cervical spine, instead of using a big plate that would sit at the base of the skull and would not be very good for him. Most of the hardware is made for adults and not for kids.
Dr. Wilson: Will that hardware preserve the motor function of his neck? Will he be able to turn his head and extend and flex it?
Dr. Einav: The injury leads to instability and destruction of both articulations between the head and neck. Therefore, those articulations won’t be able to function the same way in the future. There is a decrease of something like 50% of the flexion and extension of Hassan’s cervical spine. Therefore, I decided that in this case there would be no chance of saving Hassan’s motor function unless we performed a fusion between the head and the neck, and therefore I decided that this would be the best procedure with the best survival rate. So, in the future, he will have some diminished flexion, extension, and rotation of his head.
Dr. Wilson: How long did his surgery take?
Dr. Einav: To be honest, I don’t remember. But I can tell you that it took us time. It was very challenging to coordinate with everyone. The most problematic part of the surgery to perform is what we call “flip-over.”
The anesthesiologist intubated the patient when he was supine, and later on, we flipped him prone to operate on the spine. This maneuver can actually lead to injury by itself, and injury at this level is fatal. So, we took our time and got Hassan into the OR. The anesthesiologist did a great job with the GlideScope – inserting the endotracheal tube. Later on, we neuromonitored him. Basically, we connected Hassan’s peripheral nerves to a computer and monitored his motor function. Gently we flipped him over, and after that we saw a little change in his motor function, so we had to modify his position so we could preserve his motor function. We then started the procedure, which took a few hours. I don’t know exactly how many.
Dr. Wilson: That just speaks to how delicate this is for everything from the intubation, where typically you’re manipulating the head, to the repositioning. Clearly this requires a lot of teamwork.
What happened after the operation? How is he doing?
Dr. Einav: After the operation, Hassan had a great recovery. He’s doing well. He doesn’t have any motor or sensory deficits. He’s able to ambulate without any aid. He had no signs of infection, which can happen after a car accident, neither from his abdominal wound nor from the occipital cervical surgery. He feels well. We saw him in the clinic. We removed his collar. We monitored him at the clinic. He looked amazing.
Dr. Wilson: That’s incredible. Are there long-term risks for him that you need to be looking out for?
Dr. Einav: Yes, and that’s the reason that we are monitoring him post surgery. While he was in the hospital, we monitored his motor and sensory functions, as well as his wound healing. Later on, in the clinic, for a few weeks after surgery we monitored for any failure of the hardware and bone graft. We check for healing of the bone graft and bone substitutes we put in to heal those bones.
Dr. Wilson: He will grow, right? He’s only 12, so he still has some years of growth in him. Is he going to need more surgery or any kind of hardware upgrade?
Dr. Einav: I hope not. In my surgeries, I never rely on the hardware for long durations. If I decide to do, for example, fusion, I rely on the hardware for a certain amount of time. And then I plan that the biology will do the work. If I plan for fusion, I put bone grafts in the preferred area for a fusion. Then if the hardware fails, I wouldn’t need to take out the hardware, and there would be no change in the condition of the patient.
Dr. Wilson: What an incredible story. It’s clear that you and your team kept your cool despite a very high-acuity situation with a ton of risk. What a tremendous outcome that this boy is not only alive but fully functional. So, congratulations to you and your team. That was very strong work.
Dr. Einav: Thank you very much. I would like to thank our team. We have to remember that the surgeon is not standing alone in the war. Hassan’s story is a success story of a very big group of people from various backgrounds and religions. They work day and night to help people and save lives. To the paramedics, the physiologists, the traumatologists, the pediatricians, the nurses, the physiotherapists, and obviously the surgeons, a big thank you. His story is our success story.
Dr. Wilson: It’s inspiring to see so many people come together to do what we all are here for, which is to fight against suffering, disease, and death. Thank you for keeping up that fight. And thank you for joining me here.
Dr. Einav: Thank you very much.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
F. Perry Wilson, MD, MSCE: I am joined today by Dr. Ohad Einav. He’s a staff surgeon in orthopedics at Hadassah Medical Center in Jerusalem. He’s with me to talk about an absolutely incredible surgical case, something that is terrifying to most non–orthopedic surgeons and I imagine is fairly scary for spine surgeons like him as well. But what we don’t have is information about how this works from a medical perspective. So, first of all, Dr. Einav, thank you for taking time to speak with me today.
Ohad Einav, MD: Thank you for having me.
Dr. Wilson: Can you tell us about Suleiman Hassan and what happened to him before he came into your care?
Dr. Einav: Hassan is a 12-year-old child who was riding his bicycle on the West Bank, about 40 minutes from here. Unfortunately, he was involved in a motor vehicle accident and he suffered injuries to his abdomen and cervical spine. He was transported to our service by helicopter from the scene of the accident.
Dr. Wilson: “Injury to the cervical spine” might be something of an understatement. He had what’s called atlanto-occipital dislocation, colloquially often referred to as internal decapitation. Can you tell us what that means? It sounds terrifying.
Dr. Einav: It’s an injury to the ligaments between the occiput and the upper cervical spine, with or without bony fracture. The atlanto-occipital joint is formed by the superior articular facet of the atlas and the occipital condyle, stabilized by an articular capsule between the head and neck, and is supported by various ligaments around it that stabilize the joint and allow joint movements, including flexion, extension, and some rotation in the lower levels.
Dr. Wilson: This joint has several degrees of freedom, which means it needs a lot of support. With this type of injury, where essentially you have severing of the ligaments, is it usually survivable? How dangerous is this?
Dr. Einav: The mortality rate is 50%-60%, depending on the primary impact, the injury, transportation later on, and then the surgery and surgical management.
Dr. Wilson: Tell us a bit about this patient’s status when he came to your medical center. I assume he was in bad shape.
Dr. Einav: Hassan arrived at our medical center with a Glasgow Coma Scale score of 15. He was fully conscious. He was hemodynamically stable except for a bad laceration on his abdomen. He had a Philadelphia collar around his neck. He was transported by chopper because the paramedics suspected that he had a cervical spine injury and decided to bring him to a Level 1 trauma center.
He was monitored and we treated him according to the ATLS [advanced trauma life support] protocol. He didn’t have any gross sensory deficits, but he was a little confused about the whole situation and the accident. Therefore, we could do a general examination but we couldn’t rely on that regarding any sensory deficit that he may or may not have. We decided as a team that it would be better to slow down and control the situation. We decided not to operate on him immediately. We basically stabilized him and made sure that he didn’t have any traumatic internal organ damage. Later on we took him to the OR and performed surgery.
Dr. Wilson: It’s amazing that he had intact motor function, considering the extent of his injury. The spinal cord was spared somewhat during the injury. There must have been a moment when you realized that this kid, who was conscious and could move all four extremities, had a very severe neck injury. Was that due to a CT scan or physical exam? And what was your feeling when you saw that he had atlanto-occipital dislocation?
Dr. Einav: As a surgeon, you have a gut feeling in regard to the general examination of the patient. But I never rely on gut feelings. On the CT, I understood exactly what he had, what we needed to do, and the time frame.
Dr. Wilson: You’ve done these types of surgeries before, right? Obviously, no one has done a lot of them because this isn’t very common. But you knew what to do. Did you have a plan? Where does your experience come into play in a situation like this?
Dr. Einav: I graduated from the spine program of Toronto University, where I did a fellowship in trauma of the spine and complex spine surgery. I had very good teachers, and during my fellowship I treated a few cases in older patients that were similar but not the same. Therefore, I knew exactly what needed to be done.
Dr. Wilson: For those of us who aren’t surgeons, take us into the OR with you. This is obviously an incredibly delicate procedure. You are high up in the spinal cord at the base of the brain. The slightest mistake could have devastating consequences. What are the key elements of this procedure? What can go wrong here? What is the number-one thing you have to look out for when you’re trying to fix an internal decapitation?
Dr. Einav: The key element in surgeries of the cervical spine – trauma and complex spine surgery – is planning. I never go to the OR without knowing what I’m going to do. I have a few plans – plan A, plan B, plan C – in case something fails. So, I definitely know what the next step will be. I always think about the surgery a few hours before, if I have time to prepare.
The second thing that is very important is teamwork. The team needs to be coordinated. Everybody needs to know what their job is. With these types of injuries, it’s not the time for rookies. If you are new, please stand back and let the more experienced people do that job. I’m talking about surgeons, nurses, anesthesiologists – everyone.
Another important thing in planning is choosing the right hardware. For example, in this case we had a problem because most of the hardware is designed for adults, and we had to improvise because there isn’t a lot of hardware on the market for the pediatric population. The adult plates and screws are too big, so we had to improvise.
Dr. Wilson: Tell us more about that. How do you improvise spinal hardware for a 12-year-old?
Dr. Einav: In this case, I chose to use hardware from one of the companies that works with us.
You can see in this model the area of the injury, and the area that we worked on. To perform the surgery, I had to use some plates and rods from a different company. This company’s (NuVasive) hardware has a small attachment to the skull, which was helpful for affixing the skull to the cervical spine, instead of using a big plate that would sit at the base of the skull and would not be very good for him. Most of the hardware is made for adults and not for kids.
Dr. Wilson: Will that hardware preserve the motor function of his neck? Will he be able to turn his head and extend and flex it?
Dr. Einav: The injury leads to instability and destruction of both articulations between the head and neck. Therefore, those articulations won’t be able to function the same way in the future. There is a decrease of something like 50% of the flexion and extension of Hassan’s cervical spine. Therefore, I decided that in this case there would be no chance of saving Hassan’s motor function unless we performed a fusion between the head and the neck, and therefore I decided that this would be the best procedure with the best survival rate. So, in the future, he will have some diminished flexion, extension, and rotation of his head.
Dr. Wilson: How long did his surgery take?
Dr. Einav: To be honest, I don’t remember. But I can tell you that it took us time. It was very challenging to coordinate with everyone. The most problematic part of the surgery to perform is what we call “flip-over.”
The anesthesiologist intubated the patient when he was supine, and later on, we flipped him prone to operate on the spine. This maneuver can actually lead to injury by itself, and injury at this level is fatal. So, we took our time and got Hassan into the OR. The anesthesiologist did a great job with the GlideScope – inserting the endotracheal tube. Later on, we neuromonitored him. Basically, we connected Hassan’s peripheral nerves to a computer and monitored his motor function. Gently we flipped him over, and after that we saw a little change in his motor function, so we had to modify his position so we could preserve his motor function. We then started the procedure, which took a few hours. I don’t know exactly how many.
Dr. Wilson: That just speaks to how delicate this is for everything from the intubation, where typically you’re manipulating the head, to the repositioning. Clearly this requires a lot of teamwork.
What happened after the operation? How is he doing?
Dr. Einav: After the operation, Hassan had a great recovery. He’s doing well. He doesn’t have any motor or sensory deficits. He’s able to ambulate without any aid. He had no signs of infection, which can happen after a car accident, neither from his abdominal wound nor from the occipital cervical surgery. He feels well. We saw him in the clinic. We removed his collar. We monitored him at the clinic. He looked amazing.
Dr. Wilson: That’s incredible. Are there long-term risks for him that you need to be looking out for?
Dr. Einav: Yes, and that’s the reason that we are monitoring him post surgery. While he was in the hospital, we monitored his motor and sensory functions, as well as his wound healing. Later on, in the clinic, for a few weeks after surgery we monitored for any failure of the hardware and bone graft. We check for healing of the bone graft and bone substitutes we put in to heal those bones.
Dr. Wilson: He will grow, right? He’s only 12, so he still has some years of growth in him. Is he going to need more surgery or any kind of hardware upgrade?
Dr. Einav: I hope not. In my surgeries, I never rely on the hardware for long durations. If I decide to do, for example, fusion, I rely on the hardware for a certain amount of time. And then I plan that the biology will do the work. If I plan for fusion, I put bone grafts in the preferred area for a fusion. Then if the hardware fails, I wouldn’t need to take out the hardware, and there would be no change in the condition of the patient.
Dr. Wilson: What an incredible story. It’s clear that you and your team kept your cool despite a very high-acuity situation with a ton of risk. What a tremendous outcome that this boy is not only alive but fully functional. So, congratulations to you and your team. That was very strong work.
Dr. Einav: Thank you very much. I would like to thank our team. We have to remember that the surgeon is not standing alone in the war. Hassan’s story is a success story of a very big group of people from various backgrounds and religions. They work day and night to help people and save lives. To the paramedics, the physiologists, the traumatologists, the pediatricians, the nurses, the physiotherapists, and obviously the surgeons, a big thank you. His story is our success story.
Dr. Wilson: It’s inspiring to see so many people come together to do what we all are here for, which is to fight against suffering, disease, and death. Thank you for keeping up that fight. And thank you for joining me here.
Dr. Einav: Thank you very much.
A version of this article first appeared on Medscape.com.
Disseminated Papules and Nodules on the Skin and Oral Mucosa in an Infant
The Diagnosis: Congenital Cutaneous Langerhans Cell Histiocytosis
Although the infectious workup was positive for herpes simplex virus type 1 and cytomegalovirus antibodies, serologies for the rest of the TORCH (toxoplasmosis, other agents [syphilis, hepatitis B virus], rubella, cytomegalovirus) group of infections, as well as other bacterial, fungal, and viral infections, were negative. A skin biopsy from the right fifth toe showed a dense infiltrate of CD1a+ histiocytic cells with folded or kidney-shaped nuclei mixed with eosinophils, which was consistent with Langerhans cell histiocytosis (LCH) (Figure 1). Skin lesions were treated with hydrocortisone cream 2.5% and progressively faded over a few weeks.
Langerhans cell histiocytosis is a rare disorder with a variable clinical presentation depending on the sites affected and the extent of involvement. It can involve multiple organ systems, most commonly the skeletal system and the skin. Organ involvement is characterized by histiocyte infiltration. Acute disseminated multisystem disease most commonly is seen in children younger than 3 years.1
Congenital cutaneous LCH presents with variable skin lesions ranging from papules to vesicles, pustules, and ulcers, with onset at birth or in the neonatal period. Various morphologic traits of skin lesions have been described; the most common presentation is multiple red to yellow-brown, crusted papules with accompanying hemorrhage or erosion.1 Other cases have described an eczematous, seborrheic, diffuse eruption or erosive intertrigo. One case of a child with a solitary necrotic nodule on the scalp has been reported.2
Our patient presented with disseminated, nonblanching, purple to dark red papules and nodules of the skin and oral mucosa, as well as nail dystrophy (Figure 2). However, LCH in a neonate can mimic other causes of congenital papulonodular eruptions. Red-brown papules and nodules with or without crusting in a newborn can be mistaken for erythema toxicum neonatorum, transient neonatal pustular melanosis, congenital leukemia cutis, neonatal erythropoiesis, disseminated neonatal hemangiomatosis, infantile acropustulosis, or congenital TORCH infections such as rubella or syphilis. When LCH presents as vesicles or eroded papules or nodules in a newborn, the differential diagnosis includes incontinentia pigmenti and hereditary epidermolysis bullosa.
Langerhans cell histiocytosis may even present with a classic blueberry muffin rash that can lead clinicians to consider cutaneous metastasis from various hematologic malignancies or the more common TORCH infections. Several diagnostic tests can be performed to clarify the diagnosis, including bacterial and viral cultures and stains, serology, immunohistochemistry, flow cytometry, bone marrow aspiration, or skin biopsy.3 Langerhans cell histiocytosis is diagnosed with a combination of histology, immunohistochemistry, and clinical presentation; however, a skin biopsy is crucial. Tissue should be taken from the most easily accessible yet representative lesion. The characteristic appearance of LCH lesions is described as a dense infiltrate of histiocytic cells mixed with numerous eosinophils in the dermis.1 Histiocytes usually have folded nuclei and eosinophilic cytoplasm or kidney-shaped nuclei with prominent nucleoli. Positive CD1a and/or CD207 (Langerin) staining of the cells is required for definitive diagnosis.4 After diagnosis, it is important to obtain baseline laboratory and radiographic studies to determine the extent of systemic involvement.
Treatment of congenital LCH is tailored to the extent of organ involvement. The dermatologic manifestations resolve without medications in many cases. However, true self-resolving LCH can only be diagnosed retrospectively after a full evaluation for other sites of disease. Disseminated disease can be life-threatening and requires more active management. In cases of skin-limited disease, therapies include topical steroids, nitrogen mustard, or imiquimod; surgical resection of isolated lesions; phototherapy; or systemic therapies such as methotrexate, 6-mercaptopurine, vinblastine/vincristine, cladribine, and/or cytarabine. Symptomatic patients initially are treated with methotrexate and 6-mercaptopurine.5 Asymptomatic infants with skin-limited involvement can be managed with topical treatments.
Our patient had skin-limited disease. Abdominal ultrasonography, skeletal survey, and magnetic resonance imaging of the brain revealed no abnormalities. The patient’s family was advised to monitor him for reoccurrence of the skin lesions and to continue close follow-up with hematology and dermatology. Although congenital LCH often is self-resolving, extensive skin involvement increases the risk for internal organ involvement for several years.6 These patients require long-term follow-up for potential musculoskeletal, ophthalmologic, endocrine, hepatic, and/or pulmonary disease.
- Pan Y, Zeng X, Ge J, et al. Congenital self-healing Langerhans cell histiocytosis: clinical and pathological characteristics. Int J Clin Exp Pathol. 2019;12:2275-2278.
- Morren MA, Vanden Broecke K, Vangeebergen L, et al. Diverse cutaneous presentations of Langerhans cell histiocytosis in children: a retrospective cohort study. Pediatr Blood Cancer. 2016;63:486-492. doi:10.1002/pbc.25834
- Krooks J, Minkov M, Weatherall AG. Langerhans cell histiocytosis in children: diagnosis, differential diagnosis, treatment, sequelae, and standardized follow-up. J Am Acad Dermatol. 2018;78:1047-1056. doi:10.1016/j.jaad.2017.05.060
- Haupt R, Minkov M, Astigarraga I, et al. Langerhans cell histiocytosis (LCH): guidelines for diagnosis, clinical work-up, and treatment for patients till the age of 18 years. Pediatr Blood Cancer. 2013;60:175-184. doi:10.1002/pbc.24367
- Allen CE, Ladisch S, McClain KL. How I treat Langerhans cell histiocytosis. Blood. 2015;126:26-35. doi:10.1182/blood-2014-12-569301
- Jezierska M, Stefanowicz J, Romanowicz G, et al. Langerhans cell histiocytosis in children—a disease with many faces. recent advances in pathogenesis, diagnostic examinations and treatment. Postepy Dermatol Alergol. 2018;35:6-17. doi:10.5114/pdia.2017.67095
The Diagnosis: Congenital Cutaneous Langerhans Cell Histiocytosis
Although the infectious workup was positive for herpes simplex virus type 1 and cytomegalovirus antibodies, serologies for the rest of the TORCH (toxoplasmosis, other agents [syphilis, hepatitis B virus], rubella, cytomegalovirus) group of infections, as well as other bacterial, fungal, and viral infections, were negative. A skin biopsy from the right fifth toe showed a dense infiltrate of CD1a+ histiocytic cells with folded or kidney-shaped nuclei mixed with eosinophils, which was consistent with Langerhans cell histiocytosis (LCH) (Figure 1). Skin lesions were treated with hydrocortisone cream 2.5% and progressively faded over a few weeks.
Langerhans cell histiocytosis is a rare disorder with a variable clinical presentation depending on the sites affected and the extent of involvement. It can involve multiple organ systems, most commonly the skeletal system and the skin. Organ involvement is characterized by histiocyte infiltration. Acute disseminated multisystem disease most commonly is seen in children younger than 3 years.1
Congenital cutaneous LCH presents with variable skin lesions ranging from papules to vesicles, pustules, and ulcers, with onset at birth or in the neonatal period. Various morphologic traits of skin lesions have been described; the most common presentation is multiple red to yellow-brown, crusted papules with accompanying hemorrhage or erosion.1 Other cases have described an eczematous, seborrheic, diffuse eruption or erosive intertrigo. One case of a child with a solitary necrotic nodule on the scalp has been reported.2
Our patient presented with disseminated, nonblanching, purple to dark red papules and nodules of the skin and oral mucosa, as well as nail dystrophy (Figure 2). However, LCH in a neonate can mimic other causes of congenital papulonodular eruptions. Red-brown papules and nodules with or without crusting in a newborn can be mistaken for erythema toxicum neonatorum, transient neonatal pustular melanosis, congenital leukemia cutis, neonatal erythropoiesis, disseminated neonatal hemangiomatosis, infantile acropustulosis, or congenital TORCH infections such as rubella or syphilis. When LCH presents as vesicles or eroded papules or nodules in a newborn, the differential diagnosis includes incontinentia pigmenti and hereditary epidermolysis bullosa.
Langerhans cell histiocytosis may even present with a classic blueberry muffin rash that can lead clinicians to consider cutaneous metastasis from various hematologic malignancies or the more common TORCH infections. Several diagnostic tests can be performed to clarify the diagnosis, including bacterial and viral cultures and stains, serology, immunohistochemistry, flow cytometry, bone marrow aspiration, or skin biopsy.3 Langerhans cell histiocytosis is diagnosed with a combination of histology, immunohistochemistry, and clinical presentation; however, a skin biopsy is crucial. Tissue should be taken from the most easily accessible yet representative lesion. The characteristic appearance of LCH lesions is described as a dense infiltrate of histiocytic cells mixed with numerous eosinophils in the dermis.1 Histiocytes usually have folded nuclei and eosinophilic cytoplasm or kidney-shaped nuclei with prominent nucleoli. Positive CD1a and/or CD207 (Langerin) staining of the cells is required for definitive diagnosis.4 After diagnosis, it is important to obtain baseline laboratory and radiographic studies to determine the extent of systemic involvement.
Treatment of congenital LCH is tailored to the extent of organ involvement. The dermatologic manifestations resolve without medications in many cases. However, true self-resolving LCH can only be diagnosed retrospectively after a full evaluation for other sites of disease. Disseminated disease can be life-threatening and requires more active management. In cases of skin-limited disease, therapies include topical steroids, nitrogen mustard, or imiquimod; surgical resection of isolated lesions; phototherapy; or systemic therapies such as methotrexate, 6-mercaptopurine, vinblastine/vincristine, cladribine, and/or cytarabine. Symptomatic patients initially are treated with methotrexate and 6-mercaptopurine.5 Asymptomatic infants with skin-limited involvement can be managed with topical treatments.
Our patient had skin-limited disease. Abdominal ultrasonography, skeletal survey, and magnetic resonance imaging of the brain revealed no abnormalities. The patient’s family was advised to monitor him for reoccurrence of the skin lesions and to continue close follow-up with hematology and dermatology. Although congenital LCH often is self-resolving, extensive skin involvement increases the risk for internal organ involvement for several years.6 These patients require long-term follow-up for potential musculoskeletal, ophthalmologic, endocrine, hepatic, and/or pulmonary disease.
The Diagnosis: Congenital Cutaneous Langerhans Cell Histiocytosis
Although the infectious workup was positive for herpes simplex virus type 1 and cytomegalovirus antibodies, serologies for the rest of the TORCH (toxoplasmosis, other agents [syphilis, hepatitis B virus], rubella, cytomegalovirus) group of infections, as well as other bacterial, fungal, and viral infections, were negative. A skin biopsy from the right fifth toe showed a dense infiltrate of CD1a+ histiocytic cells with folded or kidney-shaped nuclei mixed with eosinophils, which was consistent with Langerhans cell histiocytosis (LCH) (Figure 1). Skin lesions were treated with hydrocortisone cream 2.5% and progressively faded over a few weeks.
Langerhans cell histiocytosis is a rare disorder with a variable clinical presentation depending on the sites affected and the extent of involvement. It can involve multiple organ systems, most commonly the skeletal system and the skin. Organ involvement is characterized by histiocyte infiltration. Acute disseminated multisystem disease most commonly is seen in children younger than 3 years.1
Congenital cutaneous LCH presents with variable skin lesions ranging from papules to vesicles, pustules, and ulcers, with onset at birth or in the neonatal period. Various morphologic traits of skin lesions have been described; the most common presentation is multiple red to yellow-brown, crusted papules with accompanying hemorrhage or erosion.1 Other cases have described an eczematous, seborrheic, diffuse eruption or erosive intertrigo. One case of a child with a solitary necrotic nodule on the scalp has been reported.2
Our patient presented with disseminated, nonblanching, purple to dark red papules and nodules of the skin and oral mucosa, as well as nail dystrophy (Figure 2). However, LCH in a neonate can mimic other causes of congenital papulonodular eruptions. Red-brown papules and nodules with or without crusting in a newborn can be mistaken for erythema toxicum neonatorum, transient neonatal pustular melanosis, congenital leukemia cutis, neonatal erythropoiesis, disseminated neonatal hemangiomatosis, infantile acropustulosis, or congenital TORCH infections such as rubella or syphilis. When LCH presents as vesicles or eroded papules or nodules in a newborn, the differential diagnosis includes incontinentia pigmenti and hereditary epidermolysis bullosa.
Langerhans cell histiocytosis may even present with a classic blueberry muffin rash that can lead clinicians to consider cutaneous metastasis from various hematologic malignancies or the more common TORCH infections. Several diagnostic tests can be performed to clarify the diagnosis, including bacterial and viral cultures and stains, serology, immunohistochemistry, flow cytometry, bone marrow aspiration, or skin biopsy.3 Langerhans cell histiocytosis is diagnosed with a combination of histology, immunohistochemistry, and clinical presentation; however, a skin biopsy is crucial. Tissue should be taken from the most easily accessible yet representative lesion. The characteristic appearance of LCH lesions is described as a dense infiltrate of histiocytic cells mixed with numerous eosinophils in the dermis.1 Histiocytes usually have folded nuclei and eosinophilic cytoplasm or kidney-shaped nuclei with prominent nucleoli. Positive CD1a and/or CD207 (Langerin) staining of the cells is required for definitive diagnosis.4 After diagnosis, it is important to obtain baseline laboratory and radiographic studies to determine the extent of systemic involvement.
Treatment of congenital LCH is tailored to the extent of organ involvement. The dermatologic manifestations resolve without medications in many cases. However, true self-resolving LCH can only be diagnosed retrospectively after a full evaluation for other sites of disease. Disseminated disease can be life-threatening and requires more active management. In cases of skin-limited disease, therapies include topical steroids, nitrogen mustard, or imiquimod; surgical resection of isolated lesions; phototherapy; or systemic therapies such as methotrexate, 6-mercaptopurine, vinblastine/vincristine, cladribine, and/or cytarabine. Symptomatic patients initially are treated with methotrexate and 6-mercaptopurine.5 Asymptomatic infants with skin-limited involvement can be managed with topical treatments.
Our patient had skin-limited disease. Abdominal ultrasonography, skeletal survey, and magnetic resonance imaging of the brain revealed no abnormalities. The patient’s family was advised to monitor him for reoccurrence of the skin lesions and to continue close follow-up with hematology and dermatology. Although congenital LCH often is self-resolving, extensive skin involvement increases the risk for internal organ involvement for several years.6 These patients require long-term follow-up for potential musculoskeletal, ophthalmologic, endocrine, hepatic, and/or pulmonary disease.
- Pan Y, Zeng X, Ge J, et al. Congenital self-healing Langerhans cell histiocytosis: clinical and pathological characteristics. Int J Clin Exp Pathol. 2019;12:2275-2278.
- Morren MA, Vanden Broecke K, Vangeebergen L, et al. Diverse cutaneous presentations of Langerhans cell histiocytosis in children: a retrospective cohort study. Pediatr Blood Cancer. 2016;63:486-492. doi:10.1002/pbc.25834
- Krooks J, Minkov M, Weatherall AG. Langerhans cell histiocytosis in children: diagnosis, differential diagnosis, treatment, sequelae, and standardized follow-up. J Am Acad Dermatol. 2018;78:1047-1056. doi:10.1016/j.jaad.2017.05.060
- Haupt R, Minkov M, Astigarraga I, et al. Langerhans cell histiocytosis (LCH): guidelines for diagnosis, clinical work-up, and treatment for patients till the age of 18 years. Pediatr Blood Cancer. 2013;60:175-184. doi:10.1002/pbc.24367
- Allen CE, Ladisch S, McClain KL. How I treat Langerhans cell histiocytosis. Blood. 2015;126:26-35. doi:10.1182/blood-2014-12-569301
- Jezierska M, Stefanowicz J, Romanowicz G, et al. Langerhans cell histiocytosis in children—a disease with many faces. recent advances in pathogenesis, diagnostic examinations and treatment. Postepy Dermatol Alergol. 2018;35:6-17. doi:10.5114/pdia.2017.67095
- Pan Y, Zeng X, Ge J, et al. Congenital self-healing Langerhans cell histiocytosis: clinical and pathological characteristics. Int J Clin Exp Pathol. 2019;12:2275-2278.
- Morren MA, Vanden Broecke K, Vangeebergen L, et al. Diverse cutaneous presentations of Langerhans cell histiocytosis in children: a retrospective cohort study. Pediatr Blood Cancer. 2016;63:486-492. doi:10.1002/pbc.25834
- Krooks J, Minkov M, Weatherall AG. Langerhans cell histiocytosis in children: diagnosis, differential diagnosis, treatment, sequelae, and standardized follow-up. J Am Acad Dermatol. 2018;78:1047-1056. doi:10.1016/j.jaad.2017.05.060
- Haupt R, Minkov M, Astigarraga I, et al. Langerhans cell histiocytosis (LCH): guidelines for diagnosis, clinical work-up, and treatment for patients till the age of 18 years. Pediatr Blood Cancer. 2013;60:175-184. doi:10.1002/pbc.24367
- Allen CE, Ladisch S, McClain KL. How I treat Langerhans cell histiocytosis. Blood. 2015;126:26-35. doi:10.1182/blood-2014-12-569301
- Jezierska M, Stefanowicz J, Romanowicz G, et al. Langerhans cell histiocytosis in children—a disease with many faces. recent advances in pathogenesis, diagnostic examinations and treatment. Postepy Dermatol Alergol. 2018;35:6-17. doi:10.5114/pdia.2017.67095
A 38-week-old infant boy presented at birth with disseminated, nonblanching, purple to dark red papules and nodules on the skin and oral mucosa. He was born spontaneously after an uncomplicated pregnancy. The mother experienced an episode of oral herpes simplex virus during pregnancy. The infant was otherwise healthy. Laboratory tests including a complete blood cell count and routine serum biochemical analyses were within reference range; however, an infectious workup was positive for herpes simplex virus type 1 and cytomegalovirus antibodies. Ophthalmologic and auditory screenings were normal.
Young vapers and smokers beware: Eye problems abound
Adolescents and young adults who smoked and vaped were more likely to report ocular problems including dryness, redness, pain, blurry vision, light sensitivity, and headaches, according to an observational study published in JAMA Ophthalmology.
Eye symptoms were significantly worse among young people who reported using both cigarettes and e-cigarettes than for those who said they used only one of the products, according to researchers. Symptoms were particularly frequent and severe among those who had used both products in the prior week.
“In ophthalmology clinics, I’ve increasingly noticed patients, particularly adolescents and young adults, presenting with eye-related symptoms such as dryness, irritation, and even vision disturbances,” said Anne Xuan-Lan Nguyen, MDCM, an ophthalmology resident at the University of Toronto, who led the study.
Many of these patients said they did not use contact lenses or take medications associated with eye problems, but they did report a history of using e-cigarettes and cigarettes.
This “sparked my curiosity about the possible link between smoking or vaping and ocular symptoms,” Dr. Nguyen, who conducted the research as a medical student at McGill University in Montreal, told this news organization.
E-cigarettes are the most popular tobacco product among young people. Public health data show an increasing trend toward both vaping and smoking cigarettes, known as dual use. An estimated 40% of middle- and high school–aged tobacco users report using two or more tobacco products, according to the Centers for Disease Control and Prevention. Cigarette use has been linked to ocular damage, but the effects of e-cigarettes on eyesight and the combined effect with cigarettes are not as well known.
Dr. Nguyen and her colleagues surveyed more than 4,000 people aged 13-24 about their use of cigarettes or e-cigarettes in the last 30 days, the last 7 days, or ever. Half said they had never used any tobacco product and one quarter reported having used cigarettes, vapes, or both in the last month. More than 900 respondents said they had used one or both tobacco products in the last week.
Of the respondents who had ever vaped, 55.9% said they also used cigarettes. These dual users reported more severe and frequent eye symptoms compared with users of either product alone. Up to 4% of respondents who had ever been a dual user reported daily, severe, or very severe ocular symptoms – more than in the cigarette-only or e-cigarette-only groups.
More frequent tobacco use also was associated with more ocular symptoms. Young people who smoked or vaped in the previous week reported more symptoms than did the 30-day group, who reported more symptoms than the ever-user group (those who had taken at least a puff but not in the last month).
“All these conditions we know are worse as you get older,” said Laura B. Enyedi, MD, pediatric ophthalmologist at the Duke Eye Center in Durham, N.C., who was not associated with the study. “So if young people are having symptoms, it doesn’t bode well for them as they age.”
E-cigarette use alone did not appear to be linked to eye ailments, according to the findings. But to Dr. Nguyen’s surprise the survey results showed users of vaping products spent the most time worried about their eye health compared with all other participants. Users who smoked only cigarettes reported ocular symptoms, but not as severe or frequent as those of dual users.
The researchers hypothesized that ocular problems caused by vapes and cigarettes could be classified as oxidative damage. The combustion of the cigarette and the e-cigarette solvent (propylene glycol) potentially generates free radicals that can cause oxidative stress, damaging the ocular surface and film, Dr. Nguyen said.
Ophthalmologists are “always asking about contact lens use, lid hygiene, and screen time. Here’s another thing to consider when we get those common, nonspecific complaints of symptoms like dryness, redness, and burning,” Dr. Enyedi said.
Given the observational nature of the study, the researchers cannot confirm that dual use causes ocular symptoms. But given the public health challenge that tobacco use already presents for young people, the findings provide yet another reason to counsel against tobacco use and provide cessation options, Dr. Nguyen said.
“This study is just one of many, many studies showing a significant relationship among smoking, e-cigarette use, and health outcomes,” said Bonnie Halpern-Felsher, PhD, professor of pediatrics at Stanford (Calif.) University and a coauthor of the study. “We clearly need to help young people not use at all, or quit or cut back if using.”
This study was supported by the Taube Research Faculty Scholar Endowment; the National Heart, Lung, and Blood Institute; the Food and Drug Administration Center for Tobacco Products; the National Cancer Institute; the Stanford Maternal and Child Health Research Institute; and the Research to Prevent Blindness and National Eye Institute. Dr. Halpern-Felsher reported receiving personal fees as an expert scientist in litigation against some e-cigarette companies. The other study authors and Dr. Enyedi reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Adolescents and young adults who smoked and vaped were more likely to report ocular problems including dryness, redness, pain, blurry vision, light sensitivity, and headaches, according to an observational study published in JAMA Ophthalmology.
Eye symptoms were significantly worse among young people who reported using both cigarettes and e-cigarettes than for those who said they used only one of the products, according to researchers. Symptoms were particularly frequent and severe among those who had used both products in the prior week.
“In ophthalmology clinics, I’ve increasingly noticed patients, particularly adolescents and young adults, presenting with eye-related symptoms such as dryness, irritation, and even vision disturbances,” said Anne Xuan-Lan Nguyen, MDCM, an ophthalmology resident at the University of Toronto, who led the study.
Many of these patients said they did not use contact lenses or take medications associated with eye problems, but they did report a history of using e-cigarettes and cigarettes.
This “sparked my curiosity about the possible link between smoking or vaping and ocular symptoms,” Dr. Nguyen, who conducted the research as a medical student at McGill University in Montreal, told this news organization.
E-cigarettes are the most popular tobacco product among young people. Public health data show an increasing trend toward both vaping and smoking cigarettes, known as dual use. An estimated 40% of middle- and high school–aged tobacco users report using two or more tobacco products, according to the Centers for Disease Control and Prevention. Cigarette use has been linked to ocular damage, but the effects of e-cigarettes on eyesight and the combined effect with cigarettes are not as well known.
Dr. Nguyen and her colleagues surveyed more than 4,000 people aged 13-24 about their use of cigarettes or e-cigarettes in the last 30 days, the last 7 days, or ever. Half said they had never used any tobacco product and one quarter reported having used cigarettes, vapes, or both in the last month. More than 900 respondents said they had used one or both tobacco products in the last week.
Of the respondents who had ever vaped, 55.9% said they also used cigarettes. These dual users reported more severe and frequent eye symptoms compared with users of either product alone. Up to 4% of respondents who had ever been a dual user reported daily, severe, or very severe ocular symptoms – more than in the cigarette-only or e-cigarette-only groups.
More frequent tobacco use also was associated with more ocular symptoms. Young people who smoked or vaped in the previous week reported more symptoms than did the 30-day group, who reported more symptoms than the ever-user group (those who had taken at least a puff but not in the last month).
“All these conditions we know are worse as you get older,” said Laura B. Enyedi, MD, pediatric ophthalmologist at the Duke Eye Center in Durham, N.C., who was not associated with the study. “So if young people are having symptoms, it doesn’t bode well for them as they age.”
E-cigarette use alone did not appear to be linked to eye ailments, according to the findings. But to Dr. Nguyen’s surprise the survey results showed users of vaping products spent the most time worried about their eye health compared with all other participants. Users who smoked only cigarettes reported ocular symptoms, but not as severe or frequent as those of dual users.
The researchers hypothesized that ocular problems caused by vapes and cigarettes could be classified as oxidative damage. The combustion of the cigarette and the e-cigarette solvent (propylene glycol) potentially generates free radicals that can cause oxidative stress, damaging the ocular surface and film, Dr. Nguyen said.
Ophthalmologists are “always asking about contact lens use, lid hygiene, and screen time. Here’s another thing to consider when we get those common, nonspecific complaints of symptoms like dryness, redness, and burning,” Dr. Enyedi said.
Given the observational nature of the study, the researchers cannot confirm that dual use causes ocular symptoms. But given the public health challenge that tobacco use already presents for young people, the findings provide yet another reason to counsel against tobacco use and provide cessation options, Dr. Nguyen said.
“This study is just one of many, many studies showing a significant relationship among smoking, e-cigarette use, and health outcomes,” said Bonnie Halpern-Felsher, PhD, professor of pediatrics at Stanford (Calif.) University and a coauthor of the study. “We clearly need to help young people not use at all, or quit or cut back if using.”
This study was supported by the Taube Research Faculty Scholar Endowment; the National Heart, Lung, and Blood Institute; the Food and Drug Administration Center for Tobacco Products; the National Cancer Institute; the Stanford Maternal and Child Health Research Institute; and the Research to Prevent Blindness and National Eye Institute. Dr. Halpern-Felsher reported receiving personal fees as an expert scientist in litigation against some e-cigarette companies. The other study authors and Dr. Enyedi reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Adolescents and young adults who smoked and vaped were more likely to report ocular problems including dryness, redness, pain, blurry vision, light sensitivity, and headaches, according to an observational study published in JAMA Ophthalmology.
Eye symptoms were significantly worse among young people who reported using both cigarettes and e-cigarettes than for those who said they used only one of the products, according to researchers. Symptoms were particularly frequent and severe among those who had used both products in the prior week.
“In ophthalmology clinics, I’ve increasingly noticed patients, particularly adolescents and young adults, presenting with eye-related symptoms such as dryness, irritation, and even vision disturbances,” said Anne Xuan-Lan Nguyen, MDCM, an ophthalmology resident at the University of Toronto, who led the study.
Many of these patients said they did not use contact lenses or take medications associated with eye problems, but they did report a history of using e-cigarettes and cigarettes.
This “sparked my curiosity about the possible link between smoking or vaping and ocular symptoms,” Dr. Nguyen, who conducted the research as a medical student at McGill University in Montreal, told this news organization.
E-cigarettes are the most popular tobacco product among young people. Public health data show an increasing trend toward both vaping and smoking cigarettes, known as dual use. An estimated 40% of middle- and high school–aged tobacco users report using two or more tobacco products, according to the Centers for Disease Control and Prevention. Cigarette use has been linked to ocular damage, but the effects of e-cigarettes on eyesight and the combined effect with cigarettes are not as well known.
Dr. Nguyen and her colleagues surveyed more than 4,000 people aged 13-24 about their use of cigarettes or e-cigarettes in the last 30 days, the last 7 days, or ever. Half said they had never used any tobacco product and one quarter reported having used cigarettes, vapes, or both in the last month. More than 900 respondents said they had used one or both tobacco products in the last week.
Of the respondents who had ever vaped, 55.9% said they also used cigarettes. These dual users reported more severe and frequent eye symptoms compared with users of either product alone. Up to 4% of respondents who had ever been a dual user reported daily, severe, or very severe ocular symptoms – more than in the cigarette-only or e-cigarette-only groups.
More frequent tobacco use also was associated with more ocular symptoms. Young people who smoked or vaped in the previous week reported more symptoms than did the 30-day group, who reported more symptoms than the ever-user group (those who had taken at least a puff but not in the last month).
“All these conditions we know are worse as you get older,” said Laura B. Enyedi, MD, pediatric ophthalmologist at the Duke Eye Center in Durham, N.C., who was not associated with the study. “So if young people are having symptoms, it doesn’t bode well for them as they age.”
E-cigarette use alone did not appear to be linked to eye ailments, according to the findings. But to Dr. Nguyen’s surprise the survey results showed users of vaping products spent the most time worried about their eye health compared with all other participants. Users who smoked only cigarettes reported ocular symptoms, but not as severe or frequent as those of dual users.
The researchers hypothesized that ocular problems caused by vapes and cigarettes could be classified as oxidative damage. The combustion of the cigarette and the e-cigarette solvent (propylene glycol) potentially generates free radicals that can cause oxidative stress, damaging the ocular surface and film, Dr. Nguyen said.
Ophthalmologists are “always asking about contact lens use, lid hygiene, and screen time. Here’s another thing to consider when we get those common, nonspecific complaints of symptoms like dryness, redness, and burning,” Dr. Enyedi said.
Given the observational nature of the study, the researchers cannot confirm that dual use causes ocular symptoms. But given the public health challenge that tobacco use already presents for young people, the findings provide yet another reason to counsel against tobacco use and provide cessation options, Dr. Nguyen said.
“This study is just one of many, many studies showing a significant relationship among smoking, e-cigarette use, and health outcomes,” said Bonnie Halpern-Felsher, PhD, professor of pediatrics at Stanford (Calif.) University and a coauthor of the study. “We clearly need to help young people not use at all, or quit or cut back if using.”
This study was supported by the Taube Research Faculty Scholar Endowment; the National Heart, Lung, and Blood Institute; the Food and Drug Administration Center for Tobacco Products; the National Cancer Institute; the Stanford Maternal and Child Health Research Institute; and the Research to Prevent Blindness and National Eye Institute. Dr. Halpern-Felsher reported receiving personal fees as an expert scientist in litigation against some e-cigarette companies. The other study authors and Dr. Enyedi reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA OPHTHALMOLOGY
New guideline for managing toothache in children
Nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or both medications together can effectively manage a child’s toothache as a stopgap until definitive treatment is available, according to a new guideline.
The guideline, published in the September issue of the Journal of the American Dental Association, does not recommend opioids for a toothache or after tooth extraction in this population.
Opioid prescriptions for children entail risk for hospitalization and death. Yet, some dentists continued to prescribe contraindicated opioids to young children after a Food and Drug Administration warning in 2017 about the use of tramadol and codeine in this population, the guideline notes.
Opioid prescribing to children also continued after the American Academy of Pediatric Dentistry in 2018 recommended acetaminophen and NSAIDs as first-line medications for pain management and said that the use of opioids should be “rare.”
Although the new guidance, which also covers pain management after tooth extraction, is geared toward general dentists, it could help emergency clinicians and primary care providers manage children’s pain when definitive treatment is not immediately available, the authors noted.
Definitive treatment could include pulpectomy, nonsurgical root canal, incision for drainage of an abscess, or tooth extraction.
If definitive care in 2-3 days is not possible, parents should let the health care team know, the guideline says.
“These pharmacologic strategies will alleviate dental pain temporarily until a referral for definitive dental treatment is in place,” the authors wrote.
The American Dental Association (ADA) endorsed the new guideline, which was developed by researchers with the ADA Science & Research Institute, the University of Pittsburgh School of Dental Medicine, and the Center for Integrative Global Oral Health at the University of Pennsylvania School of Dental Medicine in Philadelphia.
The guideline recommends ibuprofen and, for children older than 2 years, naproxen as NSAID options. The use of naproxen in children younger than 12 years for this purpose is off label, they noted.
The guideline suggests doses of acetaminophen and NSAIDs on the basis of age and weight that may differ from those on medication packaging.
“When acetaminophen or NSAIDs are administered as directed, the risk of harm to children from either medication is low,” the guideline states.
“While prescribing opioids to children has become less frequent overall, this guideline ensures that both dentists and parents have evidence-based recommendations to determine the most appropriate treatment for dental pain,” senior guideline author Paul Moore, DMD, PhD, MPH, professor emeritus at the University of Pittsburgh’s School of Dental Medicine, said in a news release from the ADA. “Parents and caregivers can take comfort that widely available medications that have no abuse potential, such as acetaminophen or ibuprofen, are safe and effective for helping their children find relief from short-term dental pain.”
A 2018 review by Dr. Moore and coauthors found that NSAIDs, with or without acetaminophen, were effective and minimized adverse events, relative to opioids, for acute dental pain across ages.
The new recommendations for children will “allow for better treatment of this kind of pain” and “will help prevent unnecessary prescribing of medications with abuse potential, including opioids,” Patrizia Cavazzoni, MD, director of the FDA Center for Drug Evaluation and Research, said in the news release.
The report stems from a 3-year, $1.5 million grant awarded by the FDA in 2020 to the University of Pittsburgh and the ADA Science & Research Institute to develop a clinical practice guideline for the management of acute pain in dentistry in children, adolescents, and adults. The recommendations for adolescents and adults are still in development.
The report was supported by an FDA grant, and the guideline authors received technical and methodologic support from the agency. Some authors disclosed ties to pharmaceutical companies.
A version of this article appeared on Medscape.com.
Nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or both medications together can effectively manage a child’s toothache as a stopgap until definitive treatment is available, according to a new guideline.
The guideline, published in the September issue of the Journal of the American Dental Association, does not recommend opioids for a toothache or after tooth extraction in this population.
Opioid prescriptions for children entail risk for hospitalization and death. Yet, some dentists continued to prescribe contraindicated opioids to young children after a Food and Drug Administration warning in 2017 about the use of tramadol and codeine in this population, the guideline notes.
Opioid prescribing to children also continued after the American Academy of Pediatric Dentistry in 2018 recommended acetaminophen and NSAIDs as first-line medications for pain management and said that the use of opioids should be “rare.”
Although the new guidance, which also covers pain management after tooth extraction, is geared toward general dentists, it could help emergency clinicians and primary care providers manage children’s pain when definitive treatment is not immediately available, the authors noted.
Definitive treatment could include pulpectomy, nonsurgical root canal, incision for drainage of an abscess, or tooth extraction.
If definitive care in 2-3 days is not possible, parents should let the health care team know, the guideline says.
“These pharmacologic strategies will alleviate dental pain temporarily until a referral for definitive dental treatment is in place,” the authors wrote.
The American Dental Association (ADA) endorsed the new guideline, which was developed by researchers with the ADA Science & Research Institute, the University of Pittsburgh School of Dental Medicine, and the Center for Integrative Global Oral Health at the University of Pennsylvania School of Dental Medicine in Philadelphia.
The guideline recommends ibuprofen and, for children older than 2 years, naproxen as NSAID options. The use of naproxen in children younger than 12 years for this purpose is off label, they noted.
The guideline suggests doses of acetaminophen and NSAIDs on the basis of age and weight that may differ from those on medication packaging.
“When acetaminophen or NSAIDs are administered as directed, the risk of harm to children from either medication is low,” the guideline states.
“While prescribing opioids to children has become less frequent overall, this guideline ensures that both dentists and parents have evidence-based recommendations to determine the most appropriate treatment for dental pain,” senior guideline author Paul Moore, DMD, PhD, MPH, professor emeritus at the University of Pittsburgh’s School of Dental Medicine, said in a news release from the ADA. “Parents and caregivers can take comfort that widely available medications that have no abuse potential, such as acetaminophen or ibuprofen, are safe and effective for helping their children find relief from short-term dental pain.”
A 2018 review by Dr. Moore and coauthors found that NSAIDs, with or without acetaminophen, were effective and minimized adverse events, relative to opioids, for acute dental pain across ages.
The new recommendations for children will “allow for better treatment of this kind of pain” and “will help prevent unnecessary prescribing of medications with abuse potential, including opioids,” Patrizia Cavazzoni, MD, director of the FDA Center for Drug Evaluation and Research, said in the news release.
The report stems from a 3-year, $1.5 million grant awarded by the FDA in 2020 to the University of Pittsburgh and the ADA Science & Research Institute to develop a clinical practice guideline for the management of acute pain in dentistry in children, adolescents, and adults. The recommendations for adolescents and adults are still in development.
The report was supported by an FDA grant, and the guideline authors received technical and methodologic support from the agency. Some authors disclosed ties to pharmaceutical companies.
A version of this article appeared on Medscape.com.
Nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or both medications together can effectively manage a child’s toothache as a stopgap until definitive treatment is available, according to a new guideline.
The guideline, published in the September issue of the Journal of the American Dental Association, does not recommend opioids for a toothache or after tooth extraction in this population.
Opioid prescriptions for children entail risk for hospitalization and death. Yet, some dentists continued to prescribe contraindicated opioids to young children after a Food and Drug Administration warning in 2017 about the use of tramadol and codeine in this population, the guideline notes.
Opioid prescribing to children also continued after the American Academy of Pediatric Dentistry in 2018 recommended acetaminophen and NSAIDs as first-line medications for pain management and said that the use of opioids should be “rare.”
Although the new guidance, which also covers pain management after tooth extraction, is geared toward general dentists, it could help emergency clinicians and primary care providers manage children’s pain when definitive treatment is not immediately available, the authors noted.
Definitive treatment could include pulpectomy, nonsurgical root canal, incision for drainage of an abscess, or tooth extraction.
If definitive care in 2-3 days is not possible, parents should let the health care team know, the guideline says.
“These pharmacologic strategies will alleviate dental pain temporarily until a referral for definitive dental treatment is in place,” the authors wrote.
The American Dental Association (ADA) endorsed the new guideline, which was developed by researchers with the ADA Science & Research Institute, the University of Pittsburgh School of Dental Medicine, and the Center for Integrative Global Oral Health at the University of Pennsylvania School of Dental Medicine in Philadelphia.
The guideline recommends ibuprofen and, for children older than 2 years, naproxen as NSAID options. The use of naproxen in children younger than 12 years for this purpose is off label, they noted.
The guideline suggests doses of acetaminophen and NSAIDs on the basis of age and weight that may differ from those on medication packaging.
“When acetaminophen or NSAIDs are administered as directed, the risk of harm to children from either medication is low,” the guideline states.
“While prescribing opioids to children has become less frequent overall, this guideline ensures that both dentists and parents have evidence-based recommendations to determine the most appropriate treatment for dental pain,” senior guideline author Paul Moore, DMD, PhD, MPH, professor emeritus at the University of Pittsburgh’s School of Dental Medicine, said in a news release from the ADA. “Parents and caregivers can take comfort that widely available medications that have no abuse potential, such as acetaminophen or ibuprofen, are safe and effective for helping their children find relief from short-term dental pain.”
A 2018 review by Dr. Moore and coauthors found that NSAIDs, with or without acetaminophen, were effective and minimized adverse events, relative to opioids, for acute dental pain across ages.
The new recommendations for children will “allow for better treatment of this kind of pain” and “will help prevent unnecessary prescribing of medications with abuse potential, including opioids,” Patrizia Cavazzoni, MD, director of the FDA Center for Drug Evaluation and Research, said in the news release.
The report stems from a 3-year, $1.5 million grant awarded by the FDA in 2020 to the University of Pittsburgh and the ADA Science & Research Institute to develop a clinical practice guideline for the management of acute pain in dentistry in children, adolescents, and adults. The recommendations for adolescents and adults are still in development.
The report was supported by an FDA grant, and the guideline authors received technical and methodologic support from the agency. Some authors disclosed ties to pharmaceutical companies.
A version of this article appeared on Medscape.com.
Gender-affirming surgeries nearly tripled between 2016 and 2019: Study
a new study published in JAMA Network Open found.
Breast and chest surgeries were the most common procedures performed, and the number of surgical procedures carried out increased with age. The researchers said that, in addition to legal shifts, the established safety of the surgeries and resulting increase in quality of life may also help explain the increase.
“The point of this is to raise awareness and to really document the patterns of care in the United States,” said Jason Wright, MD, an associate professor at Columbia University, New York. “We hope that people understand that these procedures are being performed more commonly and they’re out there.”
A study published in 2022 in JAMA Pediatrics found that the number of chest reconstruction surgeries among U.S. adolescents rose fourfold between 2016 and 2019.
The new study included data from 2016 to 2020 in the Nationwide Ambulatory Surgery Sample and the National Inpatient Sample. More than 48,000 patients with diagnosis codes for gender identity disorder, transsexualism, or a personal history of sex reassignment were identified. Age ranges were grouped as 12-18 (7.7%), 19-30 (52.3%), and 31-40 (21.8%).
The number of gender-affirming procedures rose from 4,552 in 2016 to a peak of 13,011 in 2019. (A slight decline to 12,818 procedures in 2020 was attributed to the COVID-19 pandemic.) The surgeries were grouped into three categories: breast and chest procedures, which occurred in 56.6% of patients; genital reconstructive surgeries (35.1%), and other facial cosmetic procedures (13.9%).
“We really wanted to try to make this as representative as we could,” Dr. Wright said. “I think this is really the best estimates that are available to date.”
Chest and breast procedures made up a higher percentage of surgeries in younger patients, while genital surgical procedures made up a higher percentage in older patients. For example, patients aged 19-30 made up 59.1% of breast or chest surgeries and 44.2% of genital surgeries. However, those aged 31-40 accounted for 26.2% of genital surgeries and 18.1% of breast or chest surgeries. For ages 41-50, the spread was more than double, accounting for 12.8% of genital surgeries and only 6.1% of breast or chest surgeries, according to the researchers.
Undocumented uptick
In addition to more inclusive health insurance, Dr. Wright said the increase in these procedures can also be attributed to studies showing their safety and the long-term association with high patient satisfaction.
Kevin Wang, MD, medical director of Providence–Swedish Health Services’ LGBTQIA+ program in Seattle, agreed that changes in health insurance coverage for gender-affirming surgery likely account in part for their increase. But he added that more clinicians are performing these procedures.
He said gender-affirming surgeries improve quality of life for the people who undergo them. The American Academy of Pediatrics has said it would be conducting a thorough review of the effects of transgender care on youth. A 2018 policy statement from the group said transgender youth should “have access to comprehensive, gender-affirming, and developmentally appropriate health care that is provided in a safe and inclusive clinical space.”
Dr. Wright cited several limitations to his group’s study that may result in the undercapture of transgender individuals and gender-affirming surgery; in particular, while the study captured inpatient and ambulatory surgical procedures in large, nationwide datasets, a small number of the procedures could have been performed in other settings.
Guiding a patient through gender-affirming care and surgical procedures can be an arduous process, including understanding their goals, using hormone therapy, and making referrals to specialists. Dr. Wang said he works to maximize his patients’ physical, mental, and emotional health, and helps them understand the risks.
He cited the double standard of a cisgender woman wanting breast augmentation without justification, but someone who identifies as transgender has many more boxes to check – for example, seeing a behavior health specialist to demonstrate they understand the risks and securing a letter of support from their primary care physician to undergo a similar procedure.
“It’s just interesting how the transgender community has to jump through so many more barriers and hoops for affirming, lifesaving procedures where you have other people who are doing it for aesthetic purposes and do not require any type of authorization,” Dr. Wang said.
Dr. Wright said he hopes the findings call attention to the need for more professionals working in the gender-affirming care field.
“I think for the medical community, it’s important to raise the idea that these procedures are becoming more common,” Dr. Wright said. “We are going to need specialists who have expertise in transgender care and surgeons who have the ability to perform these operations. Hopefully, this sheds light on the resources that are going to be required to care for these patients going forward.”
Dr. Wright reported receiving grants from Merck and personal fees from UpToDate outside the submitted work. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
a new study published in JAMA Network Open found.
Breast and chest surgeries were the most common procedures performed, and the number of surgical procedures carried out increased with age. The researchers said that, in addition to legal shifts, the established safety of the surgeries and resulting increase in quality of life may also help explain the increase.
“The point of this is to raise awareness and to really document the patterns of care in the United States,” said Jason Wright, MD, an associate professor at Columbia University, New York. “We hope that people understand that these procedures are being performed more commonly and they’re out there.”
A study published in 2022 in JAMA Pediatrics found that the number of chest reconstruction surgeries among U.S. adolescents rose fourfold between 2016 and 2019.
The new study included data from 2016 to 2020 in the Nationwide Ambulatory Surgery Sample and the National Inpatient Sample. More than 48,000 patients with diagnosis codes for gender identity disorder, transsexualism, or a personal history of sex reassignment were identified. Age ranges were grouped as 12-18 (7.7%), 19-30 (52.3%), and 31-40 (21.8%).
The number of gender-affirming procedures rose from 4,552 in 2016 to a peak of 13,011 in 2019. (A slight decline to 12,818 procedures in 2020 was attributed to the COVID-19 pandemic.) The surgeries were grouped into three categories: breast and chest procedures, which occurred in 56.6% of patients; genital reconstructive surgeries (35.1%), and other facial cosmetic procedures (13.9%).
“We really wanted to try to make this as representative as we could,” Dr. Wright said. “I think this is really the best estimates that are available to date.”
Chest and breast procedures made up a higher percentage of surgeries in younger patients, while genital surgical procedures made up a higher percentage in older patients. For example, patients aged 19-30 made up 59.1% of breast or chest surgeries and 44.2% of genital surgeries. However, those aged 31-40 accounted for 26.2% of genital surgeries and 18.1% of breast or chest surgeries. For ages 41-50, the spread was more than double, accounting for 12.8% of genital surgeries and only 6.1% of breast or chest surgeries, according to the researchers.
Undocumented uptick
In addition to more inclusive health insurance, Dr. Wright said the increase in these procedures can also be attributed to studies showing their safety and the long-term association with high patient satisfaction.
Kevin Wang, MD, medical director of Providence–Swedish Health Services’ LGBTQIA+ program in Seattle, agreed that changes in health insurance coverage for gender-affirming surgery likely account in part for their increase. But he added that more clinicians are performing these procedures.
He said gender-affirming surgeries improve quality of life for the people who undergo them. The American Academy of Pediatrics has said it would be conducting a thorough review of the effects of transgender care on youth. A 2018 policy statement from the group said transgender youth should “have access to comprehensive, gender-affirming, and developmentally appropriate health care that is provided in a safe and inclusive clinical space.”
Dr. Wright cited several limitations to his group’s study that may result in the undercapture of transgender individuals and gender-affirming surgery; in particular, while the study captured inpatient and ambulatory surgical procedures in large, nationwide datasets, a small number of the procedures could have been performed in other settings.
Guiding a patient through gender-affirming care and surgical procedures can be an arduous process, including understanding their goals, using hormone therapy, and making referrals to specialists. Dr. Wang said he works to maximize his patients’ physical, mental, and emotional health, and helps them understand the risks.
He cited the double standard of a cisgender woman wanting breast augmentation without justification, but someone who identifies as transgender has many more boxes to check – for example, seeing a behavior health specialist to demonstrate they understand the risks and securing a letter of support from their primary care physician to undergo a similar procedure.
“It’s just interesting how the transgender community has to jump through so many more barriers and hoops for affirming, lifesaving procedures where you have other people who are doing it for aesthetic purposes and do not require any type of authorization,” Dr. Wang said.
Dr. Wright said he hopes the findings call attention to the need for more professionals working in the gender-affirming care field.
“I think for the medical community, it’s important to raise the idea that these procedures are becoming more common,” Dr. Wright said. “We are going to need specialists who have expertise in transgender care and surgeons who have the ability to perform these operations. Hopefully, this sheds light on the resources that are going to be required to care for these patients going forward.”
Dr. Wright reported receiving grants from Merck and personal fees from UpToDate outside the submitted work. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
a new study published in JAMA Network Open found.
Breast and chest surgeries were the most common procedures performed, and the number of surgical procedures carried out increased with age. The researchers said that, in addition to legal shifts, the established safety of the surgeries and resulting increase in quality of life may also help explain the increase.
“The point of this is to raise awareness and to really document the patterns of care in the United States,” said Jason Wright, MD, an associate professor at Columbia University, New York. “We hope that people understand that these procedures are being performed more commonly and they’re out there.”
A study published in 2022 in JAMA Pediatrics found that the number of chest reconstruction surgeries among U.S. adolescents rose fourfold between 2016 and 2019.
The new study included data from 2016 to 2020 in the Nationwide Ambulatory Surgery Sample and the National Inpatient Sample. More than 48,000 patients with diagnosis codes for gender identity disorder, transsexualism, or a personal history of sex reassignment were identified. Age ranges were grouped as 12-18 (7.7%), 19-30 (52.3%), and 31-40 (21.8%).
The number of gender-affirming procedures rose from 4,552 in 2016 to a peak of 13,011 in 2019. (A slight decline to 12,818 procedures in 2020 was attributed to the COVID-19 pandemic.) The surgeries were grouped into three categories: breast and chest procedures, which occurred in 56.6% of patients; genital reconstructive surgeries (35.1%), and other facial cosmetic procedures (13.9%).
“We really wanted to try to make this as representative as we could,” Dr. Wright said. “I think this is really the best estimates that are available to date.”
Chest and breast procedures made up a higher percentage of surgeries in younger patients, while genital surgical procedures made up a higher percentage in older patients. For example, patients aged 19-30 made up 59.1% of breast or chest surgeries and 44.2% of genital surgeries. However, those aged 31-40 accounted for 26.2% of genital surgeries and 18.1% of breast or chest surgeries. For ages 41-50, the spread was more than double, accounting for 12.8% of genital surgeries and only 6.1% of breast or chest surgeries, according to the researchers.
Undocumented uptick
In addition to more inclusive health insurance, Dr. Wright said the increase in these procedures can also be attributed to studies showing their safety and the long-term association with high patient satisfaction.
Kevin Wang, MD, medical director of Providence–Swedish Health Services’ LGBTQIA+ program in Seattle, agreed that changes in health insurance coverage for gender-affirming surgery likely account in part for their increase. But he added that more clinicians are performing these procedures.
He said gender-affirming surgeries improve quality of life for the people who undergo them. The American Academy of Pediatrics has said it would be conducting a thorough review of the effects of transgender care on youth. A 2018 policy statement from the group said transgender youth should “have access to comprehensive, gender-affirming, and developmentally appropriate health care that is provided in a safe and inclusive clinical space.”
Dr. Wright cited several limitations to his group’s study that may result in the undercapture of transgender individuals and gender-affirming surgery; in particular, while the study captured inpatient and ambulatory surgical procedures in large, nationwide datasets, a small number of the procedures could have been performed in other settings.
Guiding a patient through gender-affirming care and surgical procedures can be an arduous process, including understanding their goals, using hormone therapy, and making referrals to specialists. Dr. Wang said he works to maximize his patients’ physical, mental, and emotional health, and helps them understand the risks.
He cited the double standard of a cisgender woman wanting breast augmentation without justification, but someone who identifies as transgender has many more boxes to check – for example, seeing a behavior health specialist to demonstrate they understand the risks and securing a letter of support from their primary care physician to undergo a similar procedure.
“It’s just interesting how the transgender community has to jump through so many more barriers and hoops for affirming, lifesaving procedures where you have other people who are doing it for aesthetic purposes and do not require any type of authorization,” Dr. Wang said.
Dr. Wright said he hopes the findings call attention to the need for more professionals working in the gender-affirming care field.
“I think for the medical community, it’s important to raise the idea that these procedures are becoming more common,” Dr. Wright said. “We are going to need specialists who have expertise in transgender care and surgeons who have the ability to perform these operations. Hopefully, this sheds light on the resources that are going to be required to care for these patients going forward.”
Dr. Wright reported receiving grants from Merck and personal fees from UpToDate outside the submitted work. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
CTE common among young athletes in largest brain donor study
Analysis of brain tissue from athletes who were exposed to RHIs and died before the age of 30 revealed neuropathological evidence of shrinkage of the brain and microscopic changes that indicate a breach of the blood-brain barrier. The case series also identified the first known American female athlete with CTE.
Nearly all of those with CTE had a mild form of the disease and 71% played only at the amateur level in youth, high school, or college sports.
“A lot of people think CTE is a result of high-level, professional play such as football, ice hockey, and boxing, but it can affect amateur athletes and can affect people at a young age,” lead author Ann McKee, MD, professor of neurology and pathology and director of the Chronic Traumatic Encephalopathy Center at Boston University, said in an interview.
The findings were published online in JAMA Neurology.
A rare look
Brain donation at younger ages is rare, so most of what is known about CTE comes from studies in older athletes.
“We’ve always known that young people could develop this disease early after just amateur high school, youth, and college exposure, but this is the largest study of donor brains at this age,” Dr. McKee said.
The case series included 152 brains of athletes who played contact sports, experienced RHIs, and died before age 30. The tissues are part of the Understanding Neurologic Injury and Traumatic Encephalopathy (UNITE) Brain Bank and were donated between February 2008 and September 2022.
Researchers reviewed the donors’ medical records and conducted retrospective interviews with the donors’ next of kin to assess cognitive symptoms, mood disturbances, and neurobehavioral issues.
Donors died between the ages of 13 and 29 years, 92.8% were male and 73% were White. In 57.2% of the cases, suicide was the cause of death, with no difference between those with or without CTE.
CTE was neuropathologically diagnosed in 41.4% of athletes, using diagnostic criteria developed by the National Institute of Neurological Disorders and Stroke.
More than 95% had mild CTE. Diagnosis was associated with older age (mean difference, 3.92 years; P < .001) and significantly more years of exposure to contact sports (11.6 vs. 8.8 years).
Among those with CTE, 71.4% played amateur sports, including football (60.9%), soccer (17.2%), hockey (7.8%), and wrestling (7%).
The cohort includes the first known American female athlete with CTE. Recruiting female brain donors has always been a challenge, Dr. McKee said. In this study, females comprised about 7% of the entire cohort and tended to be younger and play fewer years of a sport, compared with their male counterparts. All of that could lower their risk for CTE, Dr. McKee said.
“We don’t have enough brain donations to make any comments about differences between the genders, but we’ve always known that women can develop CTE,” she said. “It’s been reported after domestic violence and in an autistic woman who was a headbanger, so it was just a matter of time before we found our first case.”
Early stage of CTE?
Neuropathological analysis revealed neuronal p-tau aggregates in all CTE cases, a hallmark of the disease.
Young athletes with CTE had significantly more ventricular dilatation, suggesting atrophy or shrinkage of the brain, and more cavum septum pellucidum.
“I was surprised that even at this very young age group we could see structural changes to the gross pathology,” Dr. McKee said.
Investigators also found evidence of perivascular macrophages in the deep white matter, a microscopic change that correlated with CTE and years of play and indicates a breach of the blood-brain barrier that could allow pro-inflammatory molecules to enter the brain, setting up a neuroinflammatory response.
“Neuroinflammation is a very early change after repetitive head impacts, as well as in CTE,” Dr. McKee said. “This may be one of the mechanisms by which the inflammation starts, meaning microvascular injury might be an integral part of the pathogenesis of CTE.”
A message for clinicians
All athletes had symptoms of mood and neurobehavioral dysfunction common in people with RHIs. There were no significant differences in those clinical symptoms based on CTE diagnosis, which is likely related to the retrospective nature of the clinical evaluations, Dr. McKee said.
While the study leaves many questions about CTE in younger athletes unanswered, there is a message for clinicians and for patients in the findings, she said.
For clinicians, it’s important to note that “this young population of amateur athletes can be very symptomatic, and in all likelihood, a lot of these symptoms are reversible with proper care and management,” Dr. McKee said.
“For individual athletes, it’s important to note that 58% of this cohort did not have CTE, so just because you have these symptoms is not an indication that you have a neurodegenerative disease,” she added.
The study was funded by Andlinger Foundation, the National Football League, Mac Parkman Foundation, National Operating Committee on Standards for Athletic Equipment, and the Nick and Lynn Buoniconti Foundation, World Wrestling Entertainment, Alzheimer’s Association, National Institutes of Health, Concussion Legacy Foundation, U.S. Department of Defense and the U.S. Department of Veterans Affairs. Dr. McKee is a member of the Mackey-White Health and Safety Committee of the National Football League Players Association and reported receiving grants from the NIH and Department of Veteran Affairs and other funding from the Buoniconti Foundation and Mac Parkman Foundation during the conduct of the study.
A version of this article appeared on Medscape.com.
Analysis of brain tissue from athletes who were exposed to RHIs and died before the age of 30 revealed neuropathological evidence of shrinkage of the brain and microscopic changes that indicate a breach of the blood-brain barrier. The case series also identified the first known American female athlete with CTE.
Nearly all of those with CTE had a mild form of the disease and 71% played only at the amateur level in youth, high school, or college sports.
“A lot of people think CTE is a result of high-level, professional play such as football, ice hockey, and boxing, but it can affect amateur athletes and can affect people at a young age,” lead author Ann McKee, MD, professor of neurology and pathology and director of the Chronic Traumatic Encephalopathy Center at Boston University, said in an interview.
The findings were published online in JAMA Neurology.
A rare look
Brain donation at younger ages is rare, so most of what is known about CTE comes from studies in older athletes.
“We’ve always known that young people could develop this disease early after just amateur high school, youth, and college exposure, but this is the largest study of donor brains at this age,” Dr. McKee said.
The case series included 152 brains of athletes who played contact sports, experienced RHIs, and died before age 30. The tissues are part of the Understanding Neurologic Injury and Traumatic Encephalopathy (UNITE) Brain Bank and were donated between February 2008 and September 2022.
Researchers reviewed the donors’ medical records and conducted retrospective interviews with the donors’ next of kin to assess cognitive symptoms, mood disturbances, and neurobehavioral issues.
Donors died between the ages of 13 and 29 years, 92.8% were male and 73% were White. In 57.2% of the cases, suicide was the cause of death, with no difference between those with or without CTE.
CTE was neuropathologically diagnosed in 41.4% of athletes, using diagnostic criteria developed by the National Institute of Neurological Disorders and Stroke.
More than 95% had mild CTE. Diagnosis was associated with older age (mean difference, 3.92 years; P < .001) and significantly more years of exposure to contact sports (11.6 vs. 8.8 years).
Among those with CTE, 71.4% played amateur sports, including football (60.9%), soccer (17.2%), hockey (7.8%), and wrestling (7%).
The cohort includes the first known American female athlete with CTE. Recruiting female brain donors has always been a challenge, Dr. McKee said. In this study, females comprised about 7% of the entire cohort and tended to be younger and play fewer years of a sport, compared with their male counterparts. All of that could lower their risk for CTE, Dr. McKee said.
“We don’t have enough brain donations to make any comments about differences between the genders, but we’ve always known that women can develop CTE,” she said. “It’s been reported after domestic violence and in an autistic woman who was a headbanger, so it was just a matter of time before we found our first case.”
Early stage of CTE?
Neuropathological analysis revealed neuronal p-tau aggregates in all CTE cases, a hallmark of the disease.
Young athletes with CTE had significantly more ventricular dilatation, suggesting atrophy or shrinkage of the brain, and more cavum septum pellucidum.
“I was surprised that even at this very young age group we could see structural changes to the gross pathology,” Dr. McKee said.
Investigators also found evidence of perivascular macrophages in the deep white matter, a microscopic change that correlated with CTE and years of play and indicates a breach of the blood-brain barrier that could allow pro-inflammatory molecules to enter the brain, setting up a neuroinflammatory response.
“Neuroinflammation is a very early change after repetitive head impacts, as well as in CTE,” Dr. McKee said. “This may be one of the mechanisms by which the inflammation starts, meaning microvascular injury might be an integral part of the pathogenesis of CTE.”
A message for clinicians
All athletes had symptoms of mood and neurobehavioral dysfunction common in people with RHIs. There were no significant differences in those clinical symptoms based on CTE diagnosis, which is likely related to the retrospective nature of the clinical evaluations, Dr. McKee said.
While the study leaves many questions about CTE in younger athletes unanswered, there is a message for clinicians and for patients in the findings, she said.
For clinicians, it’s important to note that “this young population of amateur athletes can be very symptomatic, and in all likelihood, a lot of these symptoms are reversible with proper care and management,” Dr. McKee said.
“For individual athletes, it’s important to note that 58% of this cohort did not have CTE, so just because you have these symptoms is not an indication that you have a neurodegenerative disease,” she added.
The study was funded by Andlinger Foundation, the National Football League, Mac Parkman Foundation, National Operating Committee on Standards for Athletic Equipment, and the Nick and Lynn Buoniconti Foundation, World Wrestling Entertainment, Alzheimer’s Association, National Institutes of Health, Concussion Legacy Foundation, U.S. Department of Defense and the U.S. Department of Veterans Affairs. Dr. McKee is a member of the Mackey-White Health and Safety Committee of the National Football League Players Association and reported receiving grants from the NIH and Department of Veteran Affairs and other funding from the Buoniconti Foundation and Mac Parkman Foundation during the conduct of the study.
A version of this article appeared on Medscape.com.
Analysis of brain tissue from athletes who were exposed to RHIs and died before the age of 30 revealed neuropathological evidence of shrinkage of the brain and microscopic changes that indicate a breach of the blood-brain barrier. The case series also identified the first known American female athlete with CTE.
Nearly all of those with CTE had a mild form of the disease and 71% played only at the amateur level in youth, high school, or college sports.
“A lot of people think CTE is a result of high-level, professional play such as football, ice hockey, and boxing, but it can affect amateur athletes and can affect people at a young age,” lead author Ann McKee, MD, professor of neurology and pathology and director of the Chronic Traumatic Encephalopathy Center at Boston University, said in an interview.
The findings were published online in JAMA Neurology.
A rare look
Brain donation at younger ages is rare, so most of what is known about CTE comes from studies in older athletes.
“We’ve always known that young people could develop this disease early after just amateur high school, youth, and college exposure, but this is the largest study of donor brains at this age,” Dr. McKee said.
The case series included 152 brains of athletes who played contact sports, experienced RHIs, and died before age 30. The tissues are part of the Understanding Neurologic Injury and Traumatic Encephalopathy (UNITE) Brain Bank and were donated between February 2008 and September 2022.
Researchers reviewed the donors’ medical records and conducted retrospective interviews with the donors’ next of kin to assess cognitive symptoms, mood disturbances, and neurobehavioral issues.
Donors died between the ages of 13 and 29 years, 92.8% were male and 73% were White. In 57.2% of the cases, suicide was the cause of death, with no difference between those with or without CTE.
CTE was neuropathologically diagnosed in 41.4% of athletes, using diagnostic criteria developed by the National Institute of Neurological Disorders and Stroke.
More than 95% had mild CTE. Diagnosis was associated with older age (mean difference, 3.92 years; P < .001) and significantly more years of exposure to contact sports (11.6 vs. 8.8 years).
Among those with CTE, 71.4% played amateur sports, including football (60.9%), soccer (17.2%), hockey (7.8%), and wrestling (7%).
The cohort includes the first known American female athlete with CTE. Recruiting female brain donors has always been a challenge, Dr. McKee said. In this study, females comprised about 7% of the entire cohort and tended to be younger and play fewer years of a sport, compared with their male counterparts. All of that could lower their risk for CTE, Dr. McKee said.
“We don’t have enough brain donations to make any comments about differences between the genders, but we’ve always known that women can develop CTE,” she said. “It’s been reported after domestic violence and in an autistic woman who was a headbanger, so it was just a matter of time before we found our first case.”
Early stage of CTE?
Neuropathological analysis revealed neuronal p-tau aggregates in all CTE cases, a hallmark of the disease.
Young athletes with CTE had significantly more ventricular dilatation, suggesting atrophy or shrinkage of the brain, and more cavum septum pellucidum.
“I was surprised that even at this very young age group we could see structural changes to the gross pathology,” Dr. McKee said.
Investigators also found evidence of perivascular macrophages in the deep white matter, a microscopic change that correlated with CTE and years of play and indicates a breach of the blood-brain barrier that could allow pro-inflammatory molecules to enter the brain, setting up a neuroinflammatory response.
“Neuroinflammation is a very early change after repetitive head impacts, as well as in CTE,” Dr. McKee said. “This may be one of the mechanisms by which the inflammation starts, meaning microvascular injury might be an integral part of the pathogenesis of CTE.”
A message for clinicians
All athletes had symptoms of mood and neurobehavioral dysfunction common in people with RHIs. There were no significant differences in those clinical symptoms based on CTE diagnosis, which is likely related to the retrospective nature of the clinical evaluations, Dr. McKee said.
While the study leaves many questions about CTE in younger athletes unanswered, there is a message for clinicians and for patients in the findings, she said.
For clinicians, it’s important to note that “this young population of amateur athletes can be very symptomatic, and in all likelihood, a lot of these symptoms are reversible with proper care and management,” Dr. McKee said.
“For individual athletes, it’s important to note that 58% of this cohort did not have CTE, so just because you have these symptoms is not an indication that you have a neurodegenerative disease,” she added.
The study was funded by Andlinger Foundation, the National Football League, Mac Parkman Foundation, National Operating Committee on Standards for Athletic Equipment, and the Nick and Lynn Buoniconti Foundation, World Wrestling Entertainment, Alzheimer’s Association, National Institutes of Health, Concussion Legacy Foundation, U.S. Department of Defense and the U.S. Department of Veterans Affairs. Dr. McKee is a member of the Mackey-White Health and Safety Committee of the National Football League Players Association and reported receiving grants from the NIH and Department of Veteran Affairs and other funding from the Buoniconti Foundation and Mac Parkman Foundation during the conduct of the study.
A version of this article appeared on Medscape.com.