User login
Summer camps need help managing childhood anaphylaxis
ATLANTA – Summer camp personnel need a refresher course on the recognition, treatment, and prevention of allergic reactions in children, according to an online survey of camps in almost 40 U.S. states and Canadian provinces.
There’s a lot of data about how schools handle allergies but almost nothing about summer camps. To fill the gap, the investigators sent surveys across North America to 158 camp directors, 141 camp medical personnel – mostly registered nurses – and 198 camp staffers. Most of the camps were traditional rural affairs where children stay for several weeks, but there were also suburban and city day camps.
The results weren’t good. About a third of directors and staff, and almost 20% of medical personnel, said they had no education on food allergies. Less than 40% had a good understanding of the different ways that anaphylaxis can present. Less than 80% of camp directors and medical personnel and less than 50% of staff knew the right sequence for anaphylaxis treatment – epinephrine first, followed by a 911 call, and then a call to parents. Many respondents didn’t know the correct injection site for epinephrine.
They also were confused about hand sanitizers versus soap and water. Many mistakenly thought that sanitizers were as good as washing for removing allergens. “Their knowledge about how to clean tables and clean hands of food allergens was limited,” said lead investigator Margaret T. Redmond, MD, an allergist at Nationwide Children’s Hospital in Columbus, Ohio.
It all points to the need for education. “We were surprised at the poor recognition of anaphylactic symptoms. We are trying to identify the weaknesses in camps for targeted interventions. We know from the school data that, with education, people can change,” Dr. Redmond said.
During the 2016 summer session, 51 camps agreed to report epinephrine. Most were rural, with an average of 150 campers per day staying a median of 51 days. There were 12 epinephrine shots over that time, about half for peanut reactions and the rest for bee, wasp, and fire ant stings. None of the children died.
“Families that have kids with food allergies should reach out to camps about their policies and make sure they have epinephrine available at all times and that they have food allergy action plans” that staff know about, Dr. Redmond said.
The work was funded by Mylan and kaleo, both makers of epinephrine autoinjectors. Dr. Lee and Dr. Redmond had no relevant financial disclosures.
ATLANTA – Summer camp personnel need a refresher course on the recognition, treatment, and prevention of allergic reactions in children, according to an online survey of camps in almost 40 U.S. states and Canadian provinces.
There’s a lot of data about how schools handle allergies but almost nothing about summer camps. To fill the gap, the investigators sent surveys across North America to 158 camp directors, 141 camp medical personnel – mostly registered nurses – and 198 camp staffers. Most of the camps were traditional rural affairs where children stay for several weeks, but there were also suburban and city day camps.
The results weren’t good. About a third of directors and staff, and almost 20% of medical personnel, said they had no education on food allergies. Less than 40% had a good understanding of the different ways that anaphylaxis can present. Less than 80% of camp directors and medical personnel and less than 50% of staff knew the right sequence for anaphylaxis treatment – epinephrine first, followed by a 911 call, and then a call to parents. Many respondents didn’t know the correct injection site for epinephrine.
They also were confused about hand sanitizers versus soap and water. Many mistakenly thought that sanitizers were as good as washing for removing allergens. “Their knowledge about how to clean tables and clean hands of food allergens was limited,” said lead investigator Margaret T. Redmond, MD, an allergist at Nationwide Children’s Hospital in Columbus, Ohio.
It all points to the need for education. “We were surprised at the poor recognition of anaphylactic symptoms. We are trying to identify the weaknesses in camps for targeted interventions. We know from the school data that, with education, people can change,” Dr. Redmond said.
During the 2016 summer session, 51 camps agreed to report epinephrine. Most were rural, with an average of 150 campers per day staying a median of 51 days. There were 12 epinephrine shots over that time, about half for peanut reactions and the rest for bee, wasp, and fire ant stings. None of the children died.
“Families that have kids with food allergies should reach out to camps about their policies and make sure they have epinephrine available at all times and that they have food allergy action plans” that staff know about, Dr. Redmond said.
The work was funded by Mylan and kaleo, both makers of epinephrine autoinjectors. Dr. Lee and Dr. Redmond had no relevant financial disclosures.
ATLANTA – Summer camp personnel need a refresher course on the recognition, treatment, and prevention of allergic reactions in children, according to an online survey of camps in almost 40 U.S. states and Canadian provinces.
There’s a lot of data about how schools handle allergies but almost nothing about summer camps. To fill the gap, the investigators sent surveys across North America to 158 camp directors, 141 camp medical personnel – mostly registered nurses – and 198 camp staffers. Most of the camps were traditional rural affairs where children stay for several weeks, but there were also suburban and city day camps.
The results weren’t good. About a third of directors and staff, and almost 20% of medical personnel, said they had no education on food allergies. Less than 40% had a good understanding of the different ways that anaphylaxis can present. Less than 80% of camp directors and medical personnel and less than 50% of staff knew the right sequence for anaphylaxis treatment – epinephrine first, followed by a 911 call, and then a call to parents. Many respondents didn’t know the correct injection site for epinephrine.
They also were confused about hand sanitizers versus soap and water. Many mistakenly thought that sanitizers were as good as washing for removing allergens. “Their knowledge about how to clean tables and clean hands of food allergens was limited,” said lead investigator Margaret T. Redmond, MD, an allergist at Nationwide Children’s Hospital in Columbus, Ohio.
It all points to the need for education. “We were surprised at the poor recognition of anaphylactic symptoms. We are trying to identify the weaknesses in camps for targeted interventions. We know from the school data that, with education, people can change,” Dr. Redmond said.
During the 2016 summer session, 51 camps agreed to report epinephrine. Most were rural, with an average of 150 campers per day staying a median of 51 days. There were 12 epinephrine shots over that time, about half for peanut reactions and the rest for bee, wasp, and fire ant stings. None of the children died.
“Families that have kids with food allergies should reach out to camps about their policies and make sure they have epinephrine available at all times and that they have food allergy action plans” that staff know about, Dr. Redmond said.
The work was funded by Mylan and kaleo, both makers of epinephrine autoinjectors. Dr. Lee and Dr. Redmond had no relevant financial disclosures.
AT AAAAI 2017 ANNUAL MEETING
Key clinical point:
Major finding: About a third of directors and camp staff and almost 20% of medical personnel (mostly registered nurses) said they had no previous education on food allergies.
Data source: An online survey of camps in almost 40 U.S. states and Canadian provinces, including almost 500 personnel.
Disclosures: The work was funded by Mylan and kaleo, both makers of epinephrine autoinjectors. Dr. Lee and Dr. Redmond had no relevant financial disclosures.
USPSTF: No recommendation on screening for celiac disease
The current evidence is insufficient for the U.S. Preventive Services Task Force to recommend either for or against routine screening of asymptomatic people for celiac disease, according to a Recommendation Statement published online March 28 in JAMA.
The USPSTF is tasked with making recommendations regarding the effectiveness of specific preventive health care services for patients who have no related signs or symptoms. In this case, the group commissioned a systematic review of the literature on celiac disease from 1946 through June 2016, which became the basis for the evidence report informing their Recommendation Statement, said Kirsten Bibbins-Domingo, PhD, MD, chair of the USPSTF and lead author of the statement, and her associates.
However, only 4 studies out of the 3,036 that were examined addressed the question of screening adequately, and they offered few data of use. According to Roger Chou, MD, lead author of the Evidence Report, and his associates, no trials assessed the screening of asymptomatic children, adolescents, or adults for celiac disease with regard to morbidity, mortality, or quality of life. The evidence also was inadequate concerning targeted screening of at-risk individuals, and there were no studies of the effectiveness of treatment after screen-detected celiac disease was found.
There was some evidence supporting the diagnostic accuracy of the tissue transglutaminase-IgA test to detect celiac disease, but “little or no evidence ... to inform most of the key questions related to benefits and harms of screening for celiac disease in asymptomatic individuals,” said Dr. Chou, of the Pacific Northwest Evidence-Based Practice Center and Oregon Health & Science University, both in Portland, and his associates (JAMA. 2017 Mar 28. doi: 10.1001/jama.2016.10395).
Dr. Bibbins-Domingo noted that the American Academy of Family Physicians also has concluded that the evidence is insufficient to assess the balance of screening’s benefits and harms. In contrast, the American College of Gastroenterology recommends that screening be considered in asymptomatic people who have a first-degree relative with a confirmed diagnosis of celiac disease (JAMA. 2017 Mar 28. doi: 10.1001/jama.2017.1462).
In addition, the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition recommends screening at age 3 years for asymptomatic children who have conditions associated with celiac disease, including type 1 diabetes, autoimmune thyroiditis, Down syndrome, Turner syndrome, William’s syndrome, or selective IgA deficiency, said Dr. Bobbins-Domingo, who is also professor of medicine at the University of California, San Francisco.
Copies of the Recommendation Statement, the Evidence Report, the authors’ disclosures, and other materials are available at www.uspreventiveservicestaskforce.org.
AGA Resource
The AGA celiac disease patient education materials will help you discuss the disorder and management with your patients. Review and download the materials, in English and Spanish, at http://www.gastro.org/patient-care/conditions-diseases/celiac-disease.
Even though the current evidence on the effectiveness of screening for celiac disease is scarce or absent, it remains reasonable for clinicians to have a low threshold for testing patients, especially in high-risk populations such as those with an affected family member or a related autoimmune disorder.
This is because most celiac disease is unrecognized, and patients can present with diverse symptoms rather than the classic triad of abdominal pain, diarrhea, and weight loss.
Rok Seon Choung, MD, and Joseph A. Murray, MD , are in the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn. Dr. Murray reported ties to Alvine Pharmaceuticals, Alba Therapeutics, Celimmune, BioLineRx, and numerous others. Dr. Choung and Dr. Murray made these remarks in an editorial accompanying the USPSTF reports (JAMA. 2017 Mar 28;317:1221-3).
Even though the current evidence on the effectiveness of screening for celiac disease is scarce or absent, it remains reasonable for clinicians to have a low threshold for testing patients, especially in high-risk populations such as those with an affected family member or a related autoimmune disorder.
This is because most celiac disease is unrecognized, and patients can present with diverse symptoms rather than the classic triad of abdominal pain, diarrhea, and weight loss.
Rok Seon Choung, MD, and Joseph A. Murray, MD , are in the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn. Dr. Murray reported ties to Alvine Pharmaceuticals, Alba Therapeutics, Celimmune, BioLineRx, and numerous others. Dr. Choung and Dr. Murray made these remarks in an editorial accompanying the USPSTF reports (JAMA. 2017 Mar 28;317:1221-3).
Even though the current evidence on the effectiveness of screening for celiac disease is scarce or absent, it remains reasonable for clinicians to have a low threshold for testing patients, especially in high-risk populations such as those with an affected family member or a related autoimmune disorder.
This is because most celiac disease is unrecognized, and patients can present with diverse symptoms rather than the classic triad of abdominal pain, diarrhea, and weight loss.
Rok Seon Choung, MD, and Joseph A. Murray, MD , are in the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn. Dr. Murray reported ties to Alvine Pharmaceuticals, Alba Therapeutics, Celimmune, BioLineRx, and numerous others. Dr. Choung and Dr. Murray made these remarks in an editorial accompanying the USPSTF reports (JAMA. 2017 Mar 28;317:1221-3).
The current evidence is insufficient for the U.S. Preventive Services Task Force to recommend either for or against routine screening of asymptomatic people for celiac disease, according to a Recommendation Statement published online March 28 in JAMA.
The USPSTF is tasked with making recommendations regarding the effectiveness of specific preventive health care services for patients who have no related signs or symptoms. In this case, the group commissioned a systematic review of the literature on celiac disease from 1946 through June 2016, which became the basis for the evidence report informing their Recommendation Statement, said Kirsten Bibbins-Domingo, PhD, MD, chair of the USPSTF and lead author of the statement, and her associates.
However, only 4 studies out of the 3,036 that were examined addressed the question of screening adequately, and they offered few data of use. According to Roger Chou, MD, lead author of the Evidence Report, and his associates, no trials assessed the screening of asymptomatic children, adolescents, or adults for celiac disease with regard to morbidity, mortality, or quality of life. The evidence also was inadequate concerning targeted screening of at-risk individuals, and there were no studies of the effectiveness of treatment after screen-detected celiac disease was found.
There was some evidence supporting the diagnostic accuracy of the tissue transglutaminase-IgA test to detect celiac disease, but “little or no evidence ... to inform most of the key questions related to benefits and harms of screening for celiac disease in asymptomatic individuals,” said Dr. Chou, of the Pacific Northwest Evidence-Based Practice Center and Oregon Health & Science University, both in Portland, and his associates (JAMA. 2017 Mar 28. doi: 10.1001/jama.2016.10395).
Dr. Bibbins-Domingo noted that the American Academy of Family Physicians also has concluded that the evidence is insufficient to assess the balance of screening’s benefits and harms. In contrast, the American College of Gastroenterology recommends that screening be considered in asymptomatic people who have a first-degree relative with a confirmed diagnosis of celiac disease (JAMA. 2017 Mar 28. doi: 10.1001/jama.2017.1462).
In addition, the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition recommends screening at age 3 years for asymptomatic children who have conditions associated with celiac disease, including type 1 diabetes, autoimmune thyroiditis, Down syndrome, Turner syndrome, William’s syndrome, or selective IgA deficiency, said Dr. Bobbins-Domingo, who is also professor of medicine at the University of California, San Francisco.
Copies of the Recommendation Statement, the Evidence Report, the authors’ disclosures, and other materials are available at www.uspreventiveservicestaskforce.org.
AGA Resource
The AGA celiac disease patient education materials will help you discuss the disorder and management with your patients. Review and download the materials, in English and Spanish, at http://www.gastro.org/patient-care/conditions-diseases/celiac-disease.
The current evidence is insufficient for the U.S. Preventive Services Task Force to recommend either for or against routine screening of asymptomatic people for celiac disease, according to a Recommendation Statement published online March 28 in JAMA.
The USPSTF is tasked with making recommendations regarding the effectiveness of specific preventive health care services for patients who have no related signs or symptoms. In this case, the group commissioned a systematic review of the literature on celiac disease from 1946 through June 2016, which became the basis for the evidence report informing their Recommendation Statement, said Kirsten Bibbins-Domingo, PhD, MD, chair of the USPSTF and lead author of the statement, and her associates.
However, only 4 studies out of the 3,036 that were examined addressed the question of screening adequately, and they offered few data of use. According to Roger Chou, MD, lead author of the Evidence Report, and his associates, no trials assessed the screening of asymptomatic children, adolescents, or adults for celiac disease with regard to morbidity, mortality, or quality of life. The evidence also was inadequate concerning targeted screening of at-risk individuals, and there were no studies of the effectiveness of treatment after screen-detected celiac disease was found.
There was some evidence supporting the diagnostic accuracy of the tissue transglutaminase-IgA test to detect celiac disease, but “little or no evidence ... to inform most of the key questions related to benefits and harms of screening for celiac disease in asymptomatic individuals,” said Dr. Chou, of the Pacific Northwest Evidence-Based Practice Center and Oregon Health & Science University, both in Portland, and his associates (JAMA. 2017 Mar 28. doi: 10.1001/jama.2016.10395).
Dr. Bibbins-Domingo noted that the American Academy of Family Physicians also has concluded that the evidence is insufficient to assess the balance of screening’s benefits and harms. In contrast, the American College of Gastroenterology recommends that screening be considered in asymptomatic people who have a first-degree relative with a confirmed diagnosis of celiac disease (JAMA. 2017 Mar 28. doi: 10.1001/jama.2017.1462).
In addition, the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition recommends screening at age 3 years for asymptomatic children who have conditions associated with celiac disease, including type 1 diabetes, autoimmune thyroiditis, Down syndrome, Turner syndrome, William’s syndrome, or selective IgA deficiency, said Dr. Bobbins-Domingo, who is also professor of medicine at the University of California, San Francisco.
Copies of the Recommendation Statement, the Evidence Report, the authors’ disclosures, and other materials are available at www.uspreventiveservicestaskforce.org.
AGA Resource
The AGA celiac disease patient education materials will help you discuss the disorder and management with your patients. Review and download the materials, in English and Spanish, at http://www.gastro.org/patient-care/conditions-diseases/celiac-disease.
FROM JAMA
Key clinical point: The current evidence is insufficient for the USPSTF to recommend either for or against routine screening of asymptomatic people for celiac disease.
Major finding: Only 4 studies out of the 3,036 that were examined addressed the question of screening adequately.
Data source: An assessment of the benefits and harms of screening based on a review of four studies.
Disclosures: The USPSTF’s work is supported by the U.S. Agency for Healthcare Research and Quality. The authors’ financial disclosures are available at www.uspreventiveservicestaskforce.org.
Clotting Protein May Not Improve Hemorrhagic Stroke Outcomes
HOUSTON—Acute hemostatic treatment with a clotting protein does not improve short- or long-term outcomes in patients with intracerebral hemorrhage (ICH), according to research presented at the International Stroke Conference 2017.
This is not the first time rFVII has been investigated as an acute treatment for ICH, said Dr. Gladstone. In the large phase III FAST trial, rFVII reduced the growth of hematoma, but did not improve survival or functional outcome in an unselected population.
No medical interventions are available for patients with ICH, and investigators hope to identify a narrower patient population with active bleeding that might be more responsive to rFVII. This goal prompted the initiation of the SPOTLIGHT and STOP-IT studies, said Dr. Gladstone. The former study was Canadian, and the latter American.
Spot Sign Imaging Biomarker
For both studies, researchers stratified patients using the spot sign, a relatively new imaging biomarker thought to reflect active bleeding in the ICH hematoma. The hyperintense signal can easily be seen on cerebral angiography.
“It shows up like a flashlight as a bright spot in the margin of the hematoma,” Dr. Gladstone said. “When we see this, we know this patient has a possible active bleed that is likely to expand and get worse. They are at highest risk for ICH expansion and should be the best candidates for hemostatic therapy.”
Spot-positive patients were randomized to placebo or to a single IV bolus of 80 µg/kg of rFVII given in the emergency department within 6.5 hours of stroke onset. Spot-negative patients were enrolled in a prospective observational cohort, which provided data to support the sign’s use as a predictor of outcome.
Exclusion criteria included brainstem ICH; ICH with secondary cause (eg, tumor or trauma); additional treatments such as plasma or prothrombin; acute coronary ischemia; history of other strokes, angioplasty, or stenting; past thrombotic events; a Glasgow Coma Scale score less than 8; or a modified Rankin Scale (mRS) score more than 2.
These criteria, plus the relative infrequency of ICH events, compared with other cerebrovascular events, made recruitment difficult. After six years, the trials together enrolled 69 spot-positive and 72 spot-negative patients. Both studies were stopped because of the low numbers and insufficient funds.
The studies’ primary efficacy end point was 24-hour ICH volume. Secondary outcomes were 24-hour total ICH plus intraventricular hemorrhage volumes, 90-day mRS of 5 to 6, and comparisons between the spot-negative and spot-positive groups. The primary safety outcome was acute myocardial infarction, ischemic stroke, or pulmonary embolism within four days of treatment.
Results by Spot Status
Patients’ mean age was 70, although spot-positive patients were older than spot-negative patients (71 vs 61). Spot-positive patients were also less likely to have a Glasgow Coma Scale score of 15 to 16 (56% vs 66%). The mean NIH Stroke Scale score was 16 in the spot-positive group and 10 in the spot-negative group. Intraventricular hemorrhage was also more common in the spot-positive group (44% vs 18%).
After researchers adjusted for baseline ICH volume and onset-to-needle time, rFVII exerted no significant effect on either 24-hour ICH volume or 24-hour total volume. In the treated group, median ICH volume increased from 16 mL at baseline to 22 mL by 24 hours. In the placebo group, it increased from 20 mL at baseline to 29 mL at 24 hours.
In the treated group, the median total volume (ICH plus intraventricular hemorrhage) increased from 24 mL at baseline to 26 mL at 24 hours. In the placebo group, it increased from 25 mL at baseline to 31 mL at 24 hours. Researchers did not observe a significant difference between groups in the number of patients who had a volume increase of more than 6 mL or more than 33% (41% vs 43%).
A Predictor of Continued Bleeding
Spot-negative patients had lower baseline and 24-hour total hematoma volumes. In the spot-negative group, total volumes increased from a median of 13 mL at baseline to 14 mL at 24 hours. Significantly fewer spot-negative patients than spot-positive patients had hematoma growth of more than 6 mL or 33% (11% vs 43%).
The spot sign was a good predictor of continued bleeding. In all spot-positive patients, median ICH volume expanded by a median of 9 mL over 24 hours (ie, from 20 mL to 29 mL), compared with a median ICH expansion of 1 mL over 24 hours (ie, from 12 mL to 13 mL) for spot-negative patients.
There were no significant differences in 90-day mRS scores between the treated and placebo groups. One-fifth of each group had a score of 1–2, and one-fifth died. The proportion of patients with mRS scores of 3 to 5 also was similar between the groups.
Despite similar scores, the spot-negative patients had significantly better outcomes. Approximately 38% had an mRS of 0–1 at 90 days. Six percent of this group died.
In addition, treatment time intervals were prolonged in these studies, compared with those that have been achieved with antithrombotic therapy in ischemic stroke. Time from stroke onset to the emergency department was similar in both spot-positive groups taking rFVII and spot-positive controls (64 min and 66 min). Onset-to-CT time was significantly longer in the rFVII patients than in controls (89 min vs 83 min). Door-to-needle time was also longer in the rFVII patients than in controls (104 min vs 87 min), as was onset-to-needle time (195 min vs 161 min).
Thirty-seven percent of spot-positive patients receiving rFVII were treated in less than three hours. This proportion was significantly lower than the 65% that were treated that quickly in the spot-positive placebo group. No significant adverse events were related to rFVII.
Future Directions
“The spot sign predicted final ICH volume, but the magnitude of ICH expansion was small: less than we expected,” Dr. Gladstone said. “The median absolute ICH volume increase overall was only 2.5 mm, which is surprisingly small for this group of patients. And I do believe that treatment was administered too late, after most of the ICH expansion had already happened.”
Nonetheless, “there is much to learn here,” he said. “The biggest issue is that treatment was just too little, too late. We need to be catching these patients at a much earlier phase to make a difference, and that is probably the largest reason we did not see a difference.
“The spot sign “was a statistically significant predictor of final ICH volumes,” Dr. Gladstone said. It is easy to recognize on an imaging study that is routinely acquired for stroke patients.
“We are also beginning to understand that there are many different types of spot signs associated with different kinds of bleeding at different times,” he said. “We need to understand this variation further, and this should allow us to characterize the patients who are likely to be big bleeders.”
—Michelle G. Sullivan
HOUSTON—Acute hemostatic treatment with a clotting protein does not improve short- or long-term outcomes in patients with intracerebral hemorrhage (ICH), according to research presented at the International Stroke Conference 2017.
This is not the first time rFVII has been investigated as an acute treatment for ICH, said Dr. Gladstone. In the large phase III FAST trial, rFVII reduced the growth of hematoma, but did not improve survival or functional outcome in an unselected population.
No medical interventions are available for patients with ICH, and investigators hope to identify a narrower patient population with active bleeding that might be more responsive to rFVII. This goal prompted the initiation of the SPOTLIGHT and STOP-IT studies, said Dr. Gladstone. The former study was Canadian, and the latter American.
Spot Sign Imaging Biomarker
For both studies, researchers stratified patients using the spot sign, a relatively new imaging biomarker thought to reflect active bleeding in the ICH hematoma. The hyperintense signal can easily be seen on cerebral angiography.
“It shows up like a flashlight as a bright spot in the margin of the hematoma,” Dr. Gladstone said. “When we see this, we know this patient has a possible active bleed that is likely to expand and get worse. They are at highest risk for ICH expansion and should be the best candidates for hemostatic therapy.”
Spot-positive patients were randomized to placebo or to a single IV bolus of 80 µg/kg of rFVII given in the emergency department within 6.5 hours of stroke onset. Spot-negative patients were enrolled in a prospective observational cohort, which provided data to support the sign’s use as a predictor of outcome.
Exclusion criteria included brainstem ICH; ICH with secondary cause (eg, tumor or trauma); additional treatments such as plasma or prothrombin; acute coronary ischemia; history of other strokes, angioplasty, or stenting; past thrombotic events; a Glasgow Coma Scale score less than 8; or a modified Rankin Scale (mRS) score more than 2.
These criteria, plus the relative infrequency of ICH events, compared with other cerebrovascular events, made recruitment difficult. After six years, the trials together enrolled 69 spot-positive and 72 spot-negative patients. Both studies were stopped because of the low numbers and insufficient funds.
The studies’ primary efficacy end point was 24-hour ICH volume. Secondary outcomes were 24-hour total ICH plus intraventricular hemorrhage volumes, 90-day mRS of 5 to 6, and comparisons between the spot-negative and spot-positive groups. The primary safety outcome was acute myocardial infarction, ischemic stroke, or pulmonary embolism within four days of treatment.
Results by Spot Status
Patients’ mean age was 70, although spot-positive patients were older than spot-negative patients (71 vs 61). Spot-positive patients were also less likely to have a Glasgow Coma Scale score of 15 to 16 (56% vs 66%). The mean NIH Stroke Scale score was 16 in the spot-positive group and 10 in the spot-negative group. Intraventricular hemorrhage was also more common in the spot-positive group (44% vs 18%).
After researchers adjusted for baseline ICH volume and onset-to-needle time, rFVII exerted no significant effect on either 24-hour ICH volume or 24-hour total volume. In the treated group, median ICH volume increased from 16 mL at baseline to 22 mL by 24 hours. In the placebo group, it increased from 20 mL at baseline to 29 mL at 24 hours.
In the treated group, the median total volume (ICH plus intraventricular hemorrhage) increased from 24 mL at baseline to 26 mL at 24 hours. In the placebo group, it increased from 25 mL at baseline to 31 mL at 24 hours. Researchers did not observe a significant difference between groups in the number of patients who had a volume increase of more than 6 mL or more than 33% (41% vs 43%).
A Predictor of Continued Bleeding
Spot-negative patients had lower baseline and 24-hour total hematoma volumes. In the spot-negative group, total volumes increased from a median of 13 mL at baseline to 14 mL at 24 hours. Significantly fewer spot-negative patients than spot-positive patients had hematoma growth of more than 6 mL or 33% (11% vs 43%).
The spot sign was a good predictor of continued bleeding. In all spot-positive patients, median ICH volume expanded by a median of 9 mL over 24 hours (ie, from 20 mL to 29 mL), compared with a median ICH expansion of 1 mL over 24 hours (ie, from 12 mL to 13 mL) for spot-negative patients.
There were no significant differences in 90-day mRS scores between the treated and placebo groups. One-fifth of each group had a score of 1–2, and one-fifth died. The proportion of patients with mRS scores of 3 to 5 also was similar between the groups.
Despite similar scores, the spot-negative patients had significantly better outcomes. Approximately 38% had an mRS of 0–1 at 90 days. Six percent of this group died.
In addition, treatment time intervals were prolonged in these studies, compared with those that have been achieved with antithrombotic therapy in ischemic stroke. Time from stroke onset to the emergency department was similar in both spot-positive groups taking rFVII and spot-positive controls (64 min and 66 min). Onset-to-CT time was significantly longer in the rFVII patients than in controls (89 min vs 83 min). Door-to-needle time was also longer in the rFVII patients than in controls (104 min vs 87 min), as was onset-to-needle time (195 min vs 161 min).
Thirty-seven percent of spot-positive patients receiving rFVII were treated in less than three hours. This proportion was significantly lower than the 65% that were treated that quickly in the spot-positive placebo group. No significant adverse events were related to rFVII.
Future Directions
“The spot sign predicted final ICH volume, but the magnitude of ICH expansion was small: less than we expected,” Dr. Gladstone said. “The median absolute ICH volume increase overall was only 2.5 mm, which is surprisingly small for this group of patients. And I do believe that treatment was administered too late, after most of the ICH expansion had already happened.”
Nonetheless, “there is much to learn here,” he said. “The biggest issue is that treatment was just too little, too late. We need to be catching these patients at a much earlier phase to make a difference, and that is probably the largest reason we did not see a difference.
“The spot sign “was a statistically significant predictor of final ICH volumes,” Dr. Gladstone said. It is easy to recognize on an imaging study that is routinely acquired for stroke patients.
“We are also beginning to understand that there are many different types of spot signs associated with different kinds of bleeding at different times,” he said. “We need to understand this variation further, and this should allow us to characterize the patients who are likely to be big bleeders.”
—Michelle G. Sullivan
HOUSTON—Acute hemostatic treatment with a clotting protein does not improve short- or long-term outcomes in patients with intracerebral hemorrhage (ICH), according to research presented at the International Stroke Conference 2017.
This is not the first time rFVII has been investigated as an acute treatment for ICH, said Dr. Gladstone. In the large phase III FAST trial, rFVII reduced the growth of hematoma, but did not improve survival or functional outcome in an unselected population.
No medical interventions are available for patients with ICH, and investigators hope to identify a narrower patient population with active bleeding that might be more responsive to rFVII. This goal prompted the initiation of the SPOTLIGHT and STOP-IT studies, said Dr. Gladstone. The former study was Canadian, and the latter American.
Spot Sign Imaging Biomarker
For both studies, researchers stratified patients using the spot sign, a relatively new imaging biomarker thought to reflect active bleeding in the ICH hematoma. The hyperintense signal can easily be seen on cerebral angiography.
“It shows up like a flashlight as a bright spot in the margin of the hematoma,” Dr. Gladstone said. “When we see this, we know this patient has a possible active bleed that is likely to expand and get worse. They are at highest risk for ICH expansion and should be the best candidates for hemostatic therapy.”
Spot-positive patients were randomized to placebo or to a single IV bolus of 80 µg/kg of rFVII given in the emergency department within 6.5 hours of stroke onset. Spot-negative patients were enrolled in a prospective observational cohort, which provided data to support the sign’s use as a predictor of outcome.
Exclusion criteria included brainstem ICH; ICH with secondary cause (eg, tumor or trauma); additional treatments such as plasma or prothrombin; acute coronary ischemia; history of other strokes, angioplasty, or stenting; past thrombotic events; a Glasgow Coma Scale score less than 8; or a modified Rankin Scale (mRS) score more than 2.
These criteria, plus the relative infrequency of ICH events, compared with other cerebrovascular events, made recruitment difficult. After six years, the trials together enrolled 69 spot-positive and 72 spot-negative patients. Both studies were stopped because of the low numbers and insufficient funds.
The studies’ primary efficacy end point was 24-hour ICH volume. Secondary outcomes were 24-hour total ICH plus intraventricular hemorrhage volumes, 90-day mRS of 5 to 6, and comparisons between the spot-negative and spot-positive groups. The primary safety outcome was acute myocardial infarction, ischemic stroke, or pulmonary embolism within four days of treatment.
Results by Spot Status
Patients’ mean age was 70, although spot-positive patients were older than spot-negative patients (71 vs 61). Spot-positive patients were also less likely to have a Glasgow Coma Scale score of 15 to 16 (56% vs 66%). The mean NIH Stroke Scale score was 16 in the spot-positive group and 10 in the spot-negative group. Intraventricular hemorrhage was also more common in the spot-positive group (44% vs 18%).
After researchers adjusted for baseline ICH volume and onset-to-needle time, rFVII exerted no significant effect on either 24-hour ICH volume or 24-hour total volume. In the treated group, median ICH volume increased from 16 mL at baseline to 22 mL by 24 hours. In the placebo group, it increased from 20 mL at baseline to 29 mL at 24 hours.
In the treated group, the median total volume (ICH plus intraventricular hemorrhage) increased from 24 mL at baseline to 26 mL at 24 hours. In the placebo group, it increased from 25 mL at baseline to 31 mL at 24 hours. Researchers did not observe a significant difference between groups in the number of patients who had a volume increase of more than 6 mL or more than 33% (41% vs 43%).
A Predictor of Continued Bleeding
Spot-negative patients had lower baseline and 24-hour total hematoma volumes. In the spot-negative group, total volumes increased from a median of 13 mL at baseline to 14 mL at 24 hours. Significantly fewer spot-negative patients than spot-positive patients had hematoma growth of more than 6 mL or 33% (11% vs 43%).
The spot sign was a good predictor of continued bleeding. In all spot-positive patients, median ICH volume expanded by a median of 9 mL over 24 hours (ie, from 20 mL to 29 mL), compared with a median ICH expansion of 1 mL over 24 hours (ie, from 12 mL to 13 mL) for spot-negative patients.
There were no significant differences in 90-day mRS scores between the treated and placebo groups. One-fifth of each group had a score of 1–2, and one-fifth died. The proportion of patients with mRS scores of 3 to 5 also was similar between the groups.
Despite similar scores, the spot-negative patients had significantly better outcomes. Approximately 38% had an mRS of 0–1 at 90 days. Six percent of this group died.
In addition, treatment time intervals were prolonged in these studies, compared with those that have been achieved with antithrombotic therapy in ischemic stroke. Time from stroke onset to the emergency department was similar in both spot-positive groups taking rFVII and spot-positive controls (64 min and 66 min). Onset-to-CT time was significantly longer in the rFVII patients than in controls (89 min vs 83 min). Door-to-needle time was also longer in the rFVII patients than in controls (104 min vs 87 min), as was onset-to-needle time (195 min vs 161 min).
Thirty-seven percent of spot-positive patients receiving rFVII were treated in less than three hours. This proportion was significantly lower than the 65% that were treated that quickly in the spot-positive placebo group. No significant adverse events were related to rFVII.
Future Directions
“The spot sign predicted final ICH volume, but the magnitude of ICH expansion was small: less than we expected,” Dr. Gladstone said. “The median absolute ICH volume increase overall was only 2.5 mm, which is surprisingly small for this group of patients. And I do believe that treatment was administered too late, after most of the ICH expansion had already happened.”
Nonetheless, “there is much to learn here,” he said. “The biggest issue is that treatment was just too little, too late. We need to be catching these patients at a much earlier phase to make a difference, and that is probably the largest reason we did not see a difference.
“The spot sign “was a statistically significant predictor of final ICH volumes,” Dr. Gladstone said. It is easy to recognize on an imaging study that is routinely acquired for stroke patients.
“We are also beginning to understand that there are many different types of spot signs associated with different kinds of bleeding at different times,” he said. “We need to understand this variation further, and this should allow us to characterize the patients who are likely to be big bleeders.”
—Michelle G. Sullivan
Tips for Living With Alzheimer's Disease
Click here to download the PDF.
Click here to download the PDF.
Click here to download the PDF.
PPI-responsive eosinophilic esophagitis may be misnomer
PHILADELPHIA – Eosinophilic esophagitis (EoE) responsive to a proton pump inhibitor (PPI) has been characterized as PPI-responsive esophageal eosinophilia (PPI-REE), but there is no compelling evidence that it is a distinct EoE subgroup, according to an expert who updated current thinking about this disease at Digestive Diseases: New Advances.
“Multivariate analyses have not identified any feature that distinguishes PPI-REE from EoE. Why? Because they are probably the same disorder,” reported Stuart J. Spechler, MD, AGAF, codirector of the center for esophageal diseases at Baylor University Medical Center at Dallas.
Although it is true that only a subset of EoE patients respond to PPIs, few therapies are effective for all patients in any disease Dr. Spechler observed. As an example, he noted that ulcerative colitis patients who respond to sulfasalazine are not subclassified as sulfasalazine-responsive ulcerative colitis.
“I do think the term PPI-REE should be retired, although I acknowledge that not everyone in this field is ready to agree,” Dr. Spechler said at the meeting, held by Rutgers, the State University of New Jersey, and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.
The confusion regarding PPI responsiveness in EoE has been driven by the fact that acid control has been widely regarded as the only pertinent mechanism of action from PPIs. Although coexisting gastroesophageal reflux disease could explain symptom relief in some patients with EoE, no evidence of excess acid is found in many responders. Detailed evaluations of the PPI-REE subgroup relative to EOE overall emphasize this point, according to Dr. Spechler.
“Studies have shown that the clinical, endoscopic, histologic, and gene expression features of these two disorders are identical,” he reported.
The lack of distinction is now easier to understand with a growing body of evidence that PPIs have acid-independent effects relevant to benefit in EoE, according to Dr. Spechler. Tracing the advances in understanding the pathogenesis in EoE since it was first described in 1978, Dr. Spechler explained that EoE is now understood to be an antigen-driven expression of food allergy related to up-regulation of the Th2 helper adaptive response. After briefly reviewing several potential anti-inflammatory effects of PPIs, Dr. Spechler focused on evidence that PPIs inhibit the adhesion molecule eotaxin-3.
Specifically, when squamous cells from EoE patients are exposed to the cytokine interleukin-4 (IL-4), “production of eotaxin-3 is increased dramatically but you can block that cytokine Th2 stimulation with [the PPI] omeprazole,” said Dr. Spechler, citing published work by Edaire Cheng, MD, a researcher with whom he has collaborated at the University of Texas Southwestern Medical School, Dallas. This is a potentially important observation, because up-regulation of eotaxin-3 is considered a critical molecular event for the activation of eosinophils and their migration.
The relative importance of this specific mechanism for explaining the benefits of PPIs in EoE requires additional confirmation, but Dr. Spechler indicated that there is strong evidence of acid-independent effects from PPIs. In fact, in outlining an algorithm for treatment of EoE, he listed a trial of PPIs as a reasonable first choice.
“In my opinion, the major reason that we created an arbitrary distinction is this persistent notion that acid inhibition is the only possible therapeutic effect of PPIs,” Dr. Spechler reported. “I hope I have convinced you otherwise.”
In his brief update of EoE treatment in 2017, Dr. Spechler identified a trial of PPIs as first line “simply because they work.” However PPIs have been rendered even more attractive by the evidence of a plausible mechanism of action in EoE. Conversely, he cautioned that steroids are “just a band-aid” because “they cover up the allergy but the allergy remains.” Ultimately, while PPIs are a reasonable first-line therapy to control symptoms, Dr. Spechler suggested that elimination diets are ultimately the best strategy for treating the underlying cause of EoE.
Dr. Spechler reported a financial relationship with Ironwood Pharmaceuticals.
PHILADELPHIA – Eosinophilic esophagitis (EoE) responsive to a proton pump inhibitor (PPI) has been characterized as PPI-responsive esophageal eosinophilia (PPI-REE), but there is no compelling evidence that it is a distinct EoE subgroup, according to an expert who updated current thinking about this disease at Digestive Diseases: New Advances.
“Multivariate analyses have not identified any feature that distinguishes PPI-REE from EoE. Why? Because they are probably the same disorder,” reported Stuart J. Spechler, MD, AGAF, codirector of the center for esophageal diseases at Baylor University Medical Center at Dallas.
Although it is true that only a subset of EoE patients respond to PPIs, few therapies are effective for all patients in any disease Dr. Spechler observed. As an example, he noted that ulcerative colitis patients who respond to sulfasalazine are not subclassified as sulfasalazine-responsive ulcerative colitis.
“I do think the term PPI-REE should be retired, although I acknowledge that not everyone in this field is ready to agree,” Dr. Spechler said at the meeting, held by Rutgers, the State University of New Jersey, and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.
The confusion regarding PPI responsiveness in EoE has been driven by the fact that acid control has been widely regarded as the only pertinent mechanism of action from PPIs. Although coexisting gastroesophageal reflux disease could explain symptom relief in some patients with EoE, no evidence of excess acid is found in many responders. Detailed evaluations of the PPI-REE subgroup relative to EOE overall emphasize this point, according to Dr. Spechler.
“Studies have shown that the clinical, endoscopic, histologic, and gene expression features of these two disorders are identical,” he reported.
The lack of distinction is now easier to understand with a growing body of evidence that PPIs have acid-independent effects relevant to benefit in EoE, according to Dr. Spechler. Tracing the advances in understanding the pathogenesis in EoE since it was first described in 1978, Dr. Spechler explained that EoE is now understood to be an antigen-driven expression of food allergy related to up-regulation of the Th2 helper adaptive response. After briefly reviewing several potential anti-inflammatory effects of PPIs, Dr. Spechler focused on evidence that PPIs inhibit the adhesion molecule eotaxin-3.
Specifically, when squamous cells from EoE patients are exposed to the cytokine interleukin-4 (IL-4), “production of eotaxin-3 is increased dramatically but you can block that cytokine Th2 stimulation with [the PPI] omeprazole,” said Dr. Spechler, citing published work by Edaire Cheng, MD, a researcher with whom he has collaborated at the University of Texas Southwestern Medical School, Dallas. This is a potentially important observation, because up-regulation of eotaxin-3 is considered a critical molecular event for the activation of eosinophils and their migration.
The relative importance of this specific mechanism for explaining the benefits of PPIs in EoE requires additional confirmation, but Dr. Spechler indicated that there is strong evidence of acid-independent effects from PPIs. In fact, in outlining an algorithm for treatment of EoE, he listed a trial of PPIs as a reasonable first choice.
“In my opinion, the major reason that we created an arbitrary distinction is this persistent notion that acid inhibition is the only possible therapeutic effect of PPIs,” Dr. Spechler reported. “I hope I have convinced you otherwise.”
In his brief update of EoE treatment in 2017, Dr. Spechler identified a trial of PPIs as first line “simply because they work.” However PPIs have been rendered even more attractive by the evidence of a plausible mechanism of action in EoE. Conversely, he cautioned that steroids are “just a band-aid” because “they cover up the allergy but the allergy remains.” Ultimately, while PPIs are a reasonable first-line therapy to control symptoms, Dr. Spechler suggested that elimination diets are ultimately the best strategy for treating the underlying cause of EoE.
Dr. Spechler reported a financial relationship with Ironwood Pharmaceuticals.
PHILADELPHIA – Eosinophilic esophagitis (EoE) responsive to a proton pump inhibitor (PPI) has been characterized as PPI-responsive esophageal eosinophilia (PPI-REE), but there is no compelling evidence that it is a distinct EoE subgroup, according to an expert who updated current thinking about this disease at Digestive Diseases: New Advances.
“Multivariate analyses have not identified any feature that distinguishes PPI-REE from EoE. Why? Because they are probably the same disorder,” reported Stuart J. Spechler, MD, AGAF, codirector of the center for esophageal diseases at Baylor University Medical Center at Dallas.
Although it is true that only a subset of EoE patients respond to PPIs, few therapies are effective for all patients in any disease Dr. Spechler observed. As an example, he noted that ulcerative colitis patients who respond to sulfasalazine are not subclassified as sulfasalazine-responsive ulcerative colitis.
“I do think the term PPI-REE should be retired, although I acknowledge that not everyone in this field is ready to agree,” Dr. Spechler said at the meeting, held by Rutgers, the State University of New Jersey, and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.
The confusion regarding PPI responsiveness in EoE has been driven by the fact that acid control has been widely regarded as the only pertinent mechanism of action from PPIs. Although coexisting gastroesophageal reflux disease could explain symptom relief in some patients with EoE, no evidence of excess acid is found in many responders. Detailed evaluations of the PPI-REE subgroup relative to EOE overall emphasize this point, according to Dr. Spechler.
“Studies have shown that the clinical, endoscopic, histologic, and gene expression features of these two disorders are identical,” he reported.
The lack of distinction is now easier to understand with a growing body of evidence that PPIs have acid-independent effects relevant to benefit in EoE, according to Dr. Spechler. Tracing the advances in understanding the pathogenesis in EoE since it was first described in 1978, Dr. Spechler explained that EoE is now understood to be an antigen-driven expression of food allergy related to up-regulation of the Th2 helper adaptive response. After briefly reviewing several potential anti-inflammatory effects of PPIs, Dr. Spechler focused on evidence that PPIs inhibit the adhesion molecule eotaxin-3.
Specifically, when squamous cells from EoE patients are exposed to the cytokine interleukin-4 (IL-4), “production of eotaxin-3 is increased dramatically but you can block that cytokine Th2 stimulation with [the PPI] omeprazole,” said Dr. Spechler, citing published work by Edaire Cheng, MD, a researcher with whom he has collaborated at the University of Texas Southwestern Medical School, Dallas. This is a potentially important observation, because up-regulation of eotaxin-3 is considered a critical molecular event for the activation of eosinophils and their migration.
The relative importance of this specific mechanism for explaining the benefits of PPIs in EoE requires additional confirmation, but Dr. Spechler indicated that there is strong evidence of acid-independent effects from PPIs. In fact, in outlining an algorithm for treatment of EoE, he listed a trial of PPIs as a reasonable first choice.
“In my opinion, the major reason that we created an arbitrary distinction is this persistent notion that acid inhibition is the only possible therapeutic effect of PPIs,” Dr. Spechler reported. “I hope I have convinced you otherwise.”
In his brief update of EoE treatment in 2017, Dr. Spechler identified a trial of PPIs as first line “simply because they work.” However PPIs have been rendered even more attractive by the evidence of a plausible mechanism of action in EoE. Conversely, he cautioned that steroids are “just a band-aid” because “they cover up the allergy but the allergy remains.” Ultimately, while PPIs are a reasonable first-line therapy to control symptoms, Dr. Spechler suggested that elimination diets are ultimately the best strategy for treating the underlying cause of EoE.
Dr. Spechler reported a financial relationship with Ironwood Pharmaceuticals.
EXPERT ANALYSIS FROM DIGESTIVE DISEASES: NEW ADVANCES
Second-Generation Hydrogel Coils May Improve Treatment of Aneurysms
HOUSTON—Compared with standard platinum coils, second-generation hydrogel coils decrease the likelihood of adverse outcomes in the endovascular treatment of medium-sized intracranial aneurysms, according to research presented at the International Stroke Conference 2017. Hydrogel coils provide greater packing density and are associated with decreased risks of aneurysm recurrence and retreatment, compared with standard coils, according to the researchers.
Approximately 85% of subarachnoid hemorrhages result from ruptured intracranial aneurysms, which can be detected with CT angiography. A randomized controlled trial published in 2002 demonstrated that endovascular coiling was superior to neurosurgical clipping in the treatment of ruptured aneurysms. A drawback of coiling, however, is that it entails a relatively high rate of aneurysm recurrence. A novel approach adds a soft hydrogel filament into platinum coils. The hydrogel, once in contact with liquid, increases in volume, resulting in a greater fill of the underlying aneurysm.
Between October 2009 and February 2014, Prof. Taschner and colleagues randomized 513 participants, and 29 patients were excluded from the analysis. The analysis included 243 patients treated with hydrogel coils and 241 patients treated with platinum coils. Of this population, 208 participants (43%) were treated for ruptured aneurysms.
Mean packing density was significantly higher in patients treated with hydrogel coils (39%), compared with patients treated with platinum coils (31%). At 18 months, the major recurrence rate was 12% in patients receiving hydrogel coils and 18% in patients receiving platinum coils. The retreatment rate at 18 months was 3% in patients receiving hydrogel coils and 6% in patients receiving platinum coils. The researchers found no difference in modified Rankin Scale score or mortality rate between groups.
In total, 45 patients in the hydrogel coil group and 66 controls had an adverse composite primary outcome. The hydrogel coils thus reduced the proportion of adverse composite primary outcomes, compared with platinum coils, by 8.4%, said Prof. Taschner.
—Erik Greb
Suggested Reading
Gaba RC, Ansari SA, Roy SS, et al. Embolization of intracranial aneurysms with hydrogel-coated coils versus inert platinum coils: effects on packing density, coil length and quantity, procedure performance, cost, length of hospital stay, and durability of therapy. Stroke. 2006;37(6):1443-1450.
Molyneux AJ, Kerr RS, Yu LM, et al. International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion. Lancet. 2005;366(9488):809-817.
White PM, Lewis SC, Gholkar A, et al. Hydrogel-coated coils versus bare platinum coils for the endovascular treatment of intracranial aneurysms (HELPS): a randomised controlled trial. Lancet. 2011;377(9778):1655-1662.
HOUSTON—Compared with standard platinum coils, second-generation hydrogel coils decrease the likelihood of adverse outcomes in the endovascular treatment of medium-sized intracranial aneurysms, according to research presented at the International Stroke Conference 2017. Hydrogel coils provide greater packing density and are associated with decreased risks of aneurysm recurrence and retreatment, compared with standard coils, according to the researchers.
Approximately 85% of subarachnoid hemorrhages result from ruptured intracranial aneurysms, which can be detected with CT angiography. A randomized controlled trial published in 2002 demonstrated that endovascular coiling was superior to neurosurgical clipping in the treatment of ruptured aneurysms. A drawback of coiling, however, is that it entails a relatively high rate of aneurysm recurrence. A novel approach adds a soft hydrogel filament into platinum coils. The hydrogel, once in contact with liquid, increases in volume, resulting in a greater fill of the underlying aneurysm.
Between October 2009 and February 2014, Prof. Taschner and colleagues randomized 513 participants, and 29 patients were excluded from the analysis. The analysis included 243 patients treated with hydrogel coils and 241 patients treated with platinum coils. Of this population, 208 participants (43%) were treated for ruptured aneurysms.
Mean packing density was significantly higher in patients treated with hydrogel coils (39%), compared with patients treated with platinum coils (31%). At 18 months, the major recurrence rate was 12% in patients receiving hydrogel coils and 18% in patients receiving platinum coils. The retreatment rate at 18 months was 3% in patients receiving hydrogel coils and 6% in patients receiving platinum coils. The researchers found no difference in modified Rankin Scale score or mortality rate between groups.
In total, 45 patients in the hydrogel coil group and 66 controls had an adverse composite primary outcome. The hydrogel coils thus reduced the proportion of adverse composite primary outcomes, compared with platinum coils, by 8.4%, said Prof. Taschner.
—Erik Greb
Suggested Reading
Gaba RC, Ansari SA, Roy SS, et al. Embolization of intracranial aneurysms with hydrogel-coated coils versus inert platinum coils: effects on packing density, coil length and quantity, procedure performance, cost, length of hospital stay, and durability of therapy. Stroke. 2006;37(6):1443-1450.
Molyneux AJ, Kerr RS, Yu LM, et al. International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion. Lancet. 2005;366(9488):809-817.
White PM, Lewis SC, Gholkar A, et al. Hydrogel-coated coils versus bare platinum coils for the endovascular treatment of intracranial aneurysms (HELPS): a randomised controlled trial. Lancet. 2011;377(9778):1655-1662.
HOUSTON—Compared with standard platinum coils, second-generation hydrogel coils decrease the likelihood of adverse outcomes in the endovascular treatment of medium-sized intracranial aneurysms, according to research presented at the International Stroke Conference 2017. Hydrogel coils provide greater packing density and are associated with decreased risks of aneurysm recurrence and retreatment, compared with standard coils, according to the researchers.
Approximately 85% of subarachnoid hemorrhages result from ruptured intracranial aneurysms, which can be detected with CT angiography. A randomized controlled trial published in 2002 demonstrated that endovascular coiling was superior to neurosurgical clipping in the treatment of ruptured aneurysms. A drawback of coiling, however, is that it entails a relatively high rate of aneurysm recurrence. A novel approach adds a soft hydrogel filament into platinum coils. The hydrogel, once in contact with liquid, increases in volume, resulting in a greater fill of the underlying aneurysm.
Between October 2009 and February 2014, Prof. Taschner and colleagues randomized 513 participants, and 29 patients were excluded from the analysis. The analysis included 243 patients treated with hydrogel coils and 241 patients treated with platinum coils. Of this population, 208 participants (43%) were treated for ruptured aneurysms.
Mean packing density was significantly higher in patients treated with hydrogel coils (39%), compared with patients treated with platinum coils (31%). At 18 months, the major recurrence rate was 12% in patients receiving hydrogel coils and 18% in patients receiving platinum coils. The retreatment rate at 18 months was 3% in patients receiving hydrogel coils and 6% in patients receiving platinum coils. The researchers found no difference in modified Rankin Scale score or mortality rate between groups.
In total, 45 patients in the hydrogel coil group and 66 controls had an adverse composite primary outcome. The hydrogel coils thus reduced the proportion of adverse composite primary outcomes, compared with platinum coils, by 8.4%, said Prof. Taschner.
—Erik Greb
Suggested Reading
Gaba RC, Ansari SA, Roy SS, et al. Embolization of intracranial aneurysms with hydrogel-coated coils versus inert platinum coils: effects on packing density, coil length and quantity, procedure performance, cost, length of hospital stay, and durability of therapy. Stroke. 2006;37(6):1443-1450.
Molyneux AJ, Kerr RS, Yu LM, et al. International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion. Lancet. 2005;366(9488):809-817.
White PM, Lewis SC, Gholkar A, et al. Hydrogel-coated coils versus bare platinum coils for the endovascular treatment of intracranial aneurysms (HELPS): a randomised controlled trial. Lancet. 2011;377(9778):1655-1662.
Make the Diagnosis - April 2017
Trichomycosis axillaris
Trichomycosis axillaris (TA) is a bacterial infection of the genus Corynebacterium that affects hairs in the axilla. Predisposing factors include poor local hygiene, hyperhidrosis, obesity, and warm, humid climates. Gram-positive diphtheroids, classically Corynebacterium tenuis, mix with sweat on hair shafts and subsequently produce a cementing material. In the majority of cases, bacterial infection causes keratin damage to the hair shaft with sparing of the cortex. However, recent cases have reported significant invasion of the hair cortex by bacterial structures.
TA is often a clinical diagnosis. Histopathology reveals a discontinuous thick-layer coating of bacterial structures adhered to the hair shafts. Periodic acid–Schiff, gram, and Grocott silver stains are all positive. Examination of hairs with 20% hydrogen peroxide solution can provide a microscopic diagnosis. Wood lamp examination produces a weak, yellow fluorescence, and potassium hydroxide test demonstrates yellowish material of minimal translucency surrounding the hair cortex.
Complete resolution can be achieved by shaving off all the axillary hairs. It is imperative to maintain good hygiene and keep the area dry and clean. To prevent recurrence, topical benzoyl peroxide or topical antibiotics such as erythromycin and clindamycin can be applied. If axillary hyperhidrosis is concurrently present, aluminum chloride hexahydrate solution can decrease sweating and reduce the risk of bacterial regrowth. Injections of botulinum toxin can be used to treat the hyperhidrosis as well.
This patient responded well to topical erythromycin lotion.
This case and photo are courtesy of Jessica Cervantes, University of Miami Miller School of Medicine, and Dr. Bilu Martin.
Donna Bilu Martin, MD, is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/edermatologynews. To submit a case for possible publication, send an email to [email protected].
Trichomycosis axillaris
Trichomycosis axillaris (TA) is a bacterial infection of the genus Corynebacterium that affects hairs in the axilla. Predisposing factors include poor local hygiene, hyperhidrosis, obesity, and warm, humid climates. Gram-positive diphtheroids, classically Corynebacterium tenuis, mix with sweat on hair shafts and subsequently produce a cementing material. In the majority of cases, bacterial infection causes keratin damage to the hair shaft with sparing of the cortex. However, recent cases have reported significant invasion of the hair cortex by bacterial structures.
TA is often a clinical diagnosis. Histopathology reveals a discontinuous thick-layer coating of bacterial structures adhered to the hair shafts. Periodic acid–Schiff, gram, and Grocott silver stains are all positive. Examination of hairs with 20% hydrogen peroxide solution can provide a microscopic diagnosis. Wood lamp examination produces a weak, yellow fluorescence, and potassium hydroxide test demonstrates yellowish material of minimal translucency surrounding the hair cortex.
Complete resolution can be achieved by shaving off all the axillary hairs. It is imperative to maintain good hygiene and keep the area dry and clean. To prevent recurrence, topical benzoyl peroxide or topical antibiotics such as erythromycin and clindamycin can be applied. If axillary hyperhidrosis is concurrently present, aluminum chloride hexahydrate solution can decrease sweating and reduce the risk of bacterial regrowth. Injections of botulinum toxin can be used to treat the hyperhidrosis as well.
This patient responded well to topical erythromycin lotion.
This case and photo are courtesy of Jessica Cervantes, University of Miami Miller School of Medicine, and Dr. Bilu Martin.
Donna Bilu Martin, MD, is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/edermatologynews. To submit a case for possible publication, send an email to [email protected].
Trichomycosis axillaris
Trichomycosis axillaris (TA) is a bacterial infection of the genus Corynebacterium that affects hairs in the axilla. Predisposing factors include poor local hygiene, hyperhidrosis, obesity, and warm, humid climates. Gram-positive diphtheroids, classically Corynebacterium tenuis, mix with sweat on hair shafts and subsequently produce a cementing material. In the majority of cases, bacterial infection causes keratin damage to the hair shaft with sparing of the cortex. However, recent cases have reported significant invasion of the hair cortex by bacterial structures.
TA is often a clinical diagnosis. Histopathology reveals a discontinuous thick-layer coating of bacterial structures adhered to the hair shafts. Periodic acid–Schiff, gram, and Grocott silver stains are all positive. Examination of hairs with 20% hydrogen peroxide solution can provide a microscopic diagnosis. Wood lamp examination produces a weak, yellow fluorescence, and potassium hydroxide test demonstrates yellowish material of minimal translucency surrounding the hair cortex.
Complete resolution can be achieved by shaving off all the axillary hairs. It is imperative to maintain good hygiene and keep the area dry and clean. To prevent recurrence, topical benzoyl peroxide or topical antibiotics such as erythromycin and clindamycin can be applied. If axillary hyperhidrosis is concurrently present, aluminum chloride hexahydrate solution can decrease sweating and reduce the risk of bacterial regrowth. Injections of botulinum toxin can be used to treat the hyperhidrosis as well.
This patient responded well to topical erythromycin lotion.
This case and photo are courtesy of Jessica Cervantes, University of Miami Miller School of Medicine, and Dr. Bilu Martin.
Donna Bilu Martin, MD, is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/edermatologynews. To submit a case for possible publication, send an email to [email protected].
A 35-year-old male with no significant past medical history presented with the chief complaint of occasional malodorous “crust in his underarms.” He used no prior treatments, and he did report axillary hyperhidrosis.
Sublingual Apomorphine Film May Induce On State in Patients With Parkinson’s Disease
MIAMI—Among patients with Parkinson’s disease with well-defined morning off episodes, 83% achieved an on-medication state within 45 minutes of treatment with sublingual apomorphine film, according to research presented at the First Pan American Parkinson’s Disease and Movement Disorders Congress. Investigators presented preliminary results from an open-label dose titration phase of a phase III trial.
The sublingual apomorphine film, known as APL-130277, is being developed by Marlborough, Massachusetts-based Sunovion Pharmaceuticals. Apomorphine injected subcutaneously is approved for the acute, intermittent treatment of off episodes, but it is not widely used, possibly because of its parenteral administration, researchers have said. The dissolvable film consists of an apomorphine drug layer and a second layer that is designed to neutralize acid generation and enhance drug permeability. The film appeared to be effective in a phase II open-label study.
Daily Off Episodes
Participants were older than 18, had idiopathic Parkinson’s disease, and had a modified Hoehn and Yahr stage between 1 and 3 on medication. Participants were responsive to levodopa and had more than two hours of off time per day. Patients were receiving stable doses of levodopa–carbidopa. Investigators excluded patients with psychosis, dementia, or impulse control disorders; mouth cankers or sores; or prior treatment of Parkinson’s disease with a neurosurgical procedure, continuous subcutaneous apomorphine infusion, or levodopa–carbidopa enteral suspension. They also excluded patients who received subcutaneous apomorphine within seven days before screening or were taking 5-HT3 antagonists, dopamine antagonists (other than quetiapine or clozapine), or dopamine-depleting agents.
Three days prior to the dose-titration phase, patients initiated treatment with trimethobenzamide or domperidone, which may reduce nausea and vomiting that can occur during the initiation of apomorphine therapy. Patients arrived at a clinic in an off state, having not taken their regular morning levodopa dose or other adjunctive medication later than midnight, and received 10 mg of APL-130277. Investigators assessed patients using the Unified Parkinson’s Disease Rating Scale Part III prior to dosing and 15, 30, 45, 60, and 90 minutes after dosing. Patients who responded with a fully on response (ie, patients and investigators agreed that medication was benefiting mobility, stiffness, and slowness such that patients had adequate motor function to perform their normal daily activities) were considered to have completed the dose- titration phase and could proceed to randomization for the maintenance treatment phase. Patients who responded to a dose could try the next highest dose at a subsequent titration visit to assess the potential for an improved response at the higher dose. Doses increased by 5-mg increments up to 35 mg.
Of 76 patients who entered the dose-titration phase, 63 (83%) turned fully on with treatment. Among patients who turned fully on, 24 (38%) did so within 15 minutes, and 49 (78%) did so within 30 minutes. The median dose turning patients to fully on was 20 mg. Patients who turned fully on assessed time to onset as between five and 12 minutes.
Safety Data
In a presentation of preliminary safety data from the dose-titration phase, Stuart Isaacson, MD, Director of the Parkinson’s Disease and Movement Disorders Center of Boca Raton in Florida, and colleagues reported that five of the 76 patients who entered the dose-titration phase discontinued the trial due to adverse events—two due to nausea, one due to somnolence, one due to headache, and one due to presyncope. Another two patients withdrew consent, and nine patients who did not turn on at the 35-mg dose were discontinued from the trial. Other reported adverse events included dizziness, yawning, vomiting, and symptomatic hypotension. Most adverse events were considered mild. “In this preliminary analysis, APL-130277 was well tolerated in patients in the dose-titration phase,” Dr. Isaacson and colleagues concluded.
—Jake Remaly
Suggested Reading
Hauser RA, Olanow CW, Dzyngel B, et al. Sublingual apomorphine (APL-130277) for the acute conversion of OFF to ON in Parkinson’s disease. Mov Disord. 2016;31(9):1366-1372.
MIAMI—Among patients with Parkinson’s disease with well-defined morning off episodes, 83% achieved an on-medication state within 45 minutes of treatment with sublingual apomorphine film, according to research presented at the First Pan American Parkinson’s Disease and Movement Disorders Congress. Investigators presented preliminary results from an open-label dose titration phase of a phase III trial.
The sublingual apomorphine film, known as APL-130277, is being developed by Marlborough, Massachusetts-based Sunovion Pharmaceuticals. Apomorphine injected subcutaneously is approved for the acute, intermittent treatment of off episodes, but it is not widely used, possibly because of its parenteral administration, researchers have said. The dissolvable film consists of an apomorphine drug layer and a second layer that is designed to neutralize acid generation and enhance drug permeability. The film appeared to be effective in a phase II open-label study.
Daily Off Episodes
Participants were older than 18, had idiopathic Parkinson’s disease, and had a modified Hoehn and Yahr stage between 1 and 3 on medication. Participants were responsive to levodopa and had more than two hours of off time per day. Patients were receiving stable doses of levodopa–carbidopa. Investigators excluded patients with psychosis, dementia, or impulse control disorders; mouth cankers or sores; or prior treatment of Parkinson’s disease with a neurosurgical procedure, continuous subcutaneous apomorphine infusion, or levodopa–carbidopa enteral suspension. They also excluded patients who received subcutaneous apomorphine within seven days before screening or were taking 5-HT3 antagonists, dopamine antagonists (other than quetiapine or clozapine), or dopamine-depleting agents.
Three days prior to the dose-titration phase, patients initiated treatment with trimethobenzamide or domperidone, which may reduce nausea and vomiting that can occur during the initiation of apomorphine therapy. Patients arrived at a clinic in an off state, having not taken their regular morning levodopa dose or other adjunctive medication later than midnight, and received 10 mg of APL-130277. Investigators assessed patients using the Unified Parkinson’s Disease Rating Scale Part III prior to dosing and 15, 30, 45, 60, and 90 minutes after dosing. Patients who responded with a fully on response (ie, patients and investigators agreed that medication was benefiting mobility, stiffness, and slowness such that patients had adequate motor function to perform their normal daily activities) were considered to have completed the dose- titration phase and could proceed to randomization for the maintenance treatment phase. Patients who responded to a dose could try the next highest dose at a subsequent titration visit to assess the potential for an improved response at the higher dose. Doses increased by 5-mg increments up to 35 mg.
Of 76 patients who entered the dose-titration phase, 63 (83%) turned fully on with treatment. Among patients who turned fully on, 24 (38%) did so within 15 minutes, and 49 (78%) did so within 30 minutes. The median dose turning patients to fully on was 20 mg. Patients who turned fully on assessed time to onset as between five and 12 minutes.
Safety Data
In a presentation of preliminary safety data from the dose-titration phase, Stuart Isaacson, MD, Director of the Parkinson’s Disease and Movement Disorders Center of Boca Raton in Florida, and colleagues reported that five of the 76 patients who entered the dose-titration phase discontinued the trial due to adverse events—two due to nausea, one due to somnolence, one due to headache, and one due to presyncope. Another two patients withdrew consent, and nine patients who did not turn on at the 35-mg dose were discontinued from the trial. Other reported adverse events included dizziness, yawning, vomiting, and symptomatic hypotension. Most adverse events were considered mild. “In this preliminary analysis, APL-130277 was well tolerated in patients in the dose-titration phase,” Dr. Isaacson and colleagues concluded.
—Jake Remaly
Suggested Reading
Hauser RA, Olanow CW, Dzyngel B, et al. Sublingual apomorphine (APL-130277) for the acute conversion of OFF to ON in Parkinson’s disease. Mov Disord. 2016;31(9):1366-1372.
MIAMI—Among patients with Parkinson’s disease with well-defined morning off episodes, 83% achieved an on-medication state within 45 minutes of treatment with sublingual apomorphine film, according to research presented at the First Pan American Parkinson’s Disease and Movement Disorders Congress. Investigators presented preliminary results from an open-label dose titration phase of a phase III trial.
The sublingual apomorphine film, known as APL-130277, is being developed by Marlborough, Massachusetts-based Sunovion Pharmaceuticals. Apomorphine injected subcutaneously is approved for the acute, intermittent treatment of off episodes, but it is not widely used, possibly because of its parenteral administration, researchers have said. The dissolvable film consists of an apomorphine drug layer and a second layer that is designed to neutralize acid generation and enhance drug permeability. The film appeared to be effective in a phase II open-label study.
Daily Off Episodes
Participants were older than 18, had idiopathic Parkinson’s disease, and had a modified Hoehn and Yahr stage between 1 and 3 on medication. Participants were responsive to levodopa and had more than two hours of off time per day. Patients were receiving stable doses of levodopa–carbidopa. Investigators excluded patients with psychosis, dementia, or impulse control disorders; mouth cankers or sores; or prior treatment of Parkinson’s disease with a neurosurgical procedure, continuous subcutaneous apomorphine infusion, or levodopa–carbidopa enteral suspension. They also excluded patients who received subcutaneous apomorphine within seven days before screening or were taking 5-HT3 antagonists, dopamine antagonists (other than quetiapine or clozapine), or dopamine-depleting agents.
Three days prior to the dose-titration phase, patients initiated treatment with trimethobenzamide or domperidone, which may reduce nausea and vomiting that can occur during the initiation of apomorphine therapy. Patients arrived at a clinic in an off state, having not taken their regular morning levodopa dose or other adjunctive medication later than midnight, and received 10 mg of APL-130277. Investigators assessed patients using the Unified Parkinson’s Disease Rating Scale Part III prior to dosing and 15, 30, 45, 60, and 90 minutes after dosing. Patients who responded with a fully on response (ie, patients and investigators agreed that medication was benefiting mobility, stiffness, and slowness such that patients had adequate motor function to perform their normal daily activities) were considered to have completed the dose- titration phase and could proceed to randomization for the maintenance treatment phase. Patients who responded to a dose could try the next highest dose at a subsequent titration visit to assess the potential for an improved response at the higher dose. Doses increased by 5-mg increments up to 35 mg.
Of 76 patients who entered the dose-titration phase, 63 (83%) turned fully on with treatment. Among patients who turned fully on, 24 (38%) did so within 15 minutes, and 49 (78%) did so within 30 minutes. The median dose turning patients to fully on was 20 mg. Patients who turned fully on assessed time to onset as between five and 12 minutes.
Safety Data
In a presentation of preliminary safety data from the dose-titration phase, Stuart Isaacson, MD, Director of the Parkinson’s Disease and Movement Disorders Center of Boca Raton in Florida, and colleagues reported that five of the 76 patients who entered the dose-titration phase discontinued the trial due to adverse events—two due to nausea, one due to somnolence, one due to headache, and one due to presyncope. Another two patients withdrew consent, and nine patients who did not turn on at the 35-mg dose were discontinued from the trial. Other reported adverse events included dizziness, yawning, vomiting, and symptomatic hypotension. Most adverse events were considered mild. “In this preliminary analysis, APL-130277 was well tolerated in patients in the dose-titration phase,” Dr. Isaacson and colleagues concluded.
—Jake Remaly
Suggested Reading
Hauser RA, Olanow CW, Dzyngel B, et al. Sublingual apomorphine (APL-130277) for the acute conversion of OFF to ON in Parkinson’s disease. Mov Disord. 2016;31(9):1366-1372.
Down syndrome in adolescents
Teen years, no doubt, come with expected challenges. For teens with Down syndrome (DS), the challenges are exponentially greater. Although DS is associated with mental retardation, the vast majority of people with DS have only mild to moderate intellectual disability. Still, this can lead to a great deal of internal stress for the adolescent and anxiety and stress for the parents.
Many issues must be considered for the adolescent with DS. Annual surveillance changes as the child ages and the need for intervention do as well. For example, 50% of children with DS are born with congenital heart defect. During infancy, it is important to do echocardiograms to identify and follow specific lesions. Approximately 57% of adolescents with DS will develop mitral valve prolapse and 10% will develop aortic regurgitation.1 Therefore, close evaluation should be done, listening for new onset murmurs, clicks, and unexplained fatigue, and, if these are identified, an echocardiogram should be repeated.
Dysmorphic features such as midfacial hypoplasia, tonsillar hypertrophy, and narrow ear canals also lead to issues that develop in the adolescent years. Chronic otitis, conductive hearing loss because of chronic middle-ear effusion or impacted cerumen, and enlarged tonsils can result in obstructive sleep apnea. As individuals gain weight, these issues are further affected, and a sleep study may be required. Annual hearing screens are recommended.1
Musculoskeletal disorders such as ligamentous laxity and atlantoaxial instability can also present with complications in the adolescent years. Pes planus is a very common finding that can further lead to hip and knee pain. Obesity also further adds to its occurrence (14%-67%).3
Now, the most pressing and, likely, most overlooked issue is the issue of sexuality. We spend a great deal of time educating teens without DS about the risks of unprotected sex and exposures to STIs, but many assume that these issues do not affect teens with DS. Secondary sexual characteristics develop in the same manner and at the same age that they do in children without DS. Therefore, it is a safe assumption that sexual curiosity and arousal do as well. Given that there can be varying levels of mental impairment, the approach to sex education needs to be developmentally appropriate. Normalizing the feelings and having discussions on appropriate and inappropriate expression are important.
As with all teens, acceptance and inclusion are of utmost importance. Physical and learning disabilities set them apart despite shared sexual and emotional development. This can lead to anxiety, depression, and behavior issues. Understanding that these are real issues for the adolescent with DS is important when providing the appropriate resources and support.
Management of the menstrual cycle can add new challenges for both the adolescent and the parent and, thus, should be investigated during health maintenance visits. Amenorrhea can result from introduction of hormonal therapy and should be considered. Sexual abuse also is increased in this age group, so close supervision and awareness of this issue are important.
Assisting parents of children with DS through the teen years is imperative. Making them aware of local support groups and national organizations for children with disabilities will help them navigate these years. The American Academy of Pediatrics has guidelines for health maintenance for DS.2
Dr. Pearce is a pediatrician in Frankfort, Ill. She reported no relevant financial disclosures. Email her at [email protected]
References
1. J Pediatr Health Care. 2006 May-Jun;20(3):198-205.
2. Pediatrics. 2011. doi: 10.1542/peds.2011-1605.
3. Clin Obes. 2015;5(2):52-9.
Correction, 7/26/17: An earlier version of this article misstated a recommendation about radiologic evaluation of the cervical spine in asymptomatic children
Teen years, no doubt, come with expected challenges. For teens with Down syndrome (DS), the challenges are exponentially greater. Although DS is associated with mental retardation, the vast majority of people with DS have only mild to moderate intellectual disability. Still, this can lead to a great deal of internal stress for the adolescent and anxiety and stress for the parents.
Many issues must be considered for the adolescent with DS. Annual surveillance changes as the child ages and the need for intervention do as well. For example, 50% of children with DS are born with congenital heart defect. During infancy, it is important to do echocardiograms to identify and follow specific lesions. Approximately 57% of adolescents with DS will develop mitral valve prolapse and 10% will develop aortic regurgitation.1 Therefore, close evaluation should be done, listening for new onset murmurs, clicks, and unexplained fatigue, and, if these are identified, an echocardiogram should be repeated.
Dysmorphic features such as midfacial hypoplasia, tonsillar hypertrophy, and narrow ear canals also lead to issues that develop in the adolescent years. Chronic otitis, conductive hearing loss because of chronic middle-ear effusion or impacted cerumen, and enlarged tonsils can result in obstructive sleep apnea. As individuals gain weight, these issues are further affected, and a sleep study may be required. Annual hearing screens are recommended.1
Musculoskeletal disorders such as ligamentous laxity and atlantoaxial instability can also present with complications in the adolescent years. Pes planus is a very common finding that can further lead to hip and knee pain. Obesity also further adds to its occurrence (14%-67%).3
Now, the most pressing and, likely, most overlooked issue is the issue of sexuality. We spend a great deal of time educating teens without DS about the risks of unprotected sex and exposures to STIs, but many assume that these issues do not affect teens with DS. Secondary sexual characteristics develop in the same manner and at the same age that they do in children without DS. Therefore, it is a safe assumption that sexual curiosity and arousal do as well. Given that there can be varying levels of mental impairment, the approach to sex education needs to be developmentally appropriate. Normalizing the feelings and having discussions on appropriate and inappropriate expression are important.
As with all teens, acceptance and inclusion are of utmost importance. Physical and learning disabilities set them apart despite shared sexual and emotional development. This can lead to anxiety, depression, and behavior issues. Understanding that these are real issues for the adolescent with DS is important when providing the appropriate resources and support.
Management of the menstrual cycle can add new challenges for both the adolescent and the parent and, thus, should be investigated during health maintenance visits. Amenorrhea can result from introduction of hormonal therapy and should be considered. Sexual abuse also is increased in this age group, so close supervision and awareness of this issue are important.
Assisting parents of children with DS through the teen years is imperative. Making them aware of local support groups and national organizations for children with disabilities will help them navigate these years. The American Academy of Pediatrics has guidelines for health maintenance for DS.2
Dr. Pearce is a pediatrician in Frankfort, Ill. She reported no relevant financial disclosures. Email her at [email protected]
References
1. J Pediatr Health Care. 2006 May-Jun;20(3):198-205.
2. Pediatrics. 2011. doi: 10.1542/peds.2011-1605.
3. Clin Obes. 2015;5(2):52-9.
Correction, 7/26/17: An earlier version of this article misstated a recommendation about radiologic evaluation of the cervical spine in asymptomatic children
Teen years, no doubt, come with expected challenges. For teens with Down syndrome (DS), the challenges are exponentially greater. Although DS is associated with mental retardation, the vast majority of people with DS have only mild to moderate intellectual disability. Still, this can lead to a great deal of internal stress for the adolescent and anxiety and stress for the parents.
Many issues must be considered for the adolescent with DS. Annual surveillance changes as the child ages and the need for intervention do as well. For example, 50% of children with DS are born with congenital heart defect. During infancy, it is important to do echocardiograms to identify and follow specific lesions. Approximately 57% of adolescents with DS will develop mitral valve prolapse and 10% will develop aortic regurgitation.1 Therefore, close evaluation should be done, listening for new onset murmurs, clicks, and unexplained fatigue, and, if these are identified, an echocardiogram should be repeated.
Dysmorphic features such as midfacial hypoplasia, tonsillar hypertrophy, and narrow ear canals also lead to issues that develop in the adolescent years. Chronic otitis, conductive hearing loss because of chronic middle-ear effusion or impacted cerumen, and enlarged tonsils can result in obstructive sleep apnea. As individuals gain weight, these issues are further affected, and a sleep study may be required. Annual hearing screens are recommended.1
Musculoskeletal disorders such as ligamentous laxity and atlantoaxial instability can also present with complications in the adolescent years. Pes planus is a very common finding that can further lead to hip and knee pain. Obesity also further adds to its occurrence (14%-67%).3
Now, the most pressing and, likely, most overlooked issue is the issue of sexuality. We spend a great deal of time educating teens without DS about the risks of unprotected sex and exposures to STIs, but many assume that these issues do not affect teens with DS. Secondary sexual characteristics develop in the same manner and at the same age that they do in children without DS. Therefore, it is a safe assumption that sexual curiosity and arousal do as well. Given that there can be varying levels of mental impairment, the approach to sex education needs to be developmentally appropriate. Normalizing the feelings and having discussions on appropriate and inappropriate expression are important.
As with all teens, acceptance and inclusion are of utmost importance. Physical and learning disabilities set them apart despite shared sexual and emotional development. This can lead to anxiety, depression, and behavior issues. Understanding that these are real issues for the adolescent with DS is important when providing the appropriate resources and support.
Management of the menstrual cycle can add new challenges for both the adolescent and the parent and, thus, should be investigated during health maintenance visits. Amenorrhea can result from introduction of hormonal therapy and should be considered. Sexual abuse also is increased in this age group, so close supervision and awareness of this issue are important.
Assisting parents of children with DS through the teen years is imperative. Making them aware of local support groups and national organizations for children with disabilities will help them navigate these years. The American Academy of Pediatrics has guidelines for health maintenance for DS.2
Dr. Pearce is a pediatrician in Frankfort, Ill. She reported no relevant financial disclosures. Email her at [email protected]
References
1. J Pediatr Health Care. 2006 May-Jun;20(3):198-205.
2. Pediatrics. 2011. doi: 10.1542/peds.2011-1605.
3. Clin Obes. 2015;5(2):52-9.
Correction, 7/26/17: An earlier version of this article misstated a recommendation about radiologic evaluation of the cervical spine in asymptomatic children
The many faces of formaldehyde contact allergy
ATLANTA – Formaldehyde has various clinical presentations and variable thresholds to trigger allergic contact dermatitis, so it requires a high index of suspicion, according to Salma de la Feld, MD.
It may present as irritant contact dermatitis, allergic contact dermatitis (especially to the hands and face), airborne allergic contact dermatitis, or systemic allergic contact dermatitis (to aspartame).
From most-releasing to least-releasing, these chemicals include quaternium-15, diazolidinyl urea, DMDM hydantoin, imidazolidinyl urea, and bronopol. Exposure can come from personal care products, prescription topical steroids and acne creams, Brazilian hair keratin, cigarettes, and textiles made of blended fabrics, as well as occupations such as a leather handler, surgical nurse, pathology lab worker, and hairdresser.
“Patients can be allergic to either the formaldehyde that [a product] releases or the non–formaldehyde component or both,” said Dr. de la Feld, who is a dermatologist at Emory University, Atlanta.
Recent studies suggest that the formaldehyde allergen should be tested at 2% instead of at 1%. “You do get a few more irritant reactions [with this approach], but you’re also going to catch more people who have a true positive reaction,” she said. “If you see a borderline papule with a little pink, that might be an irritant. You want to test for the formaldehyde releasers. When you do have a positive reaction, you want to have a high index of suspicion. Patients have to be strict in what personal care products they’re using. Some people might be able to tolerate a low concentration of formaldehyde in some products and that magic number differs between patients.”
From a treatment standpoint, Dr. de la Feld advises patients to avoid all formaldehyde releasers and to wear 100% fabrics in an effort to steer clear of textile exposure. “I like to have people be really strict [in their avoidance] when they’re first starting out,” she said. “They don’t like it, but I’ll say, ‘You’re so itchy. Let’s start really strict to get you clear and better.’ Once they’re better and there’s that one moisturizing cream that they really love, then [you] can do a repeat open application test. If nothing happens, it’s probably safe. If [they] start getting red and itchy there, [they] should probably throw away that moisturizer.”
Fragrance
Fragrance, which was named Allergen of the Year in 2007, is another common contact allergen. An estimated 4%-11% of the worldwide population is allergic to fragrance mix, while 1.6%-10.8% is allergic to balsam of Peru. T.R.U.E. tests for the allergen often yield false-negative results. Clinicians who fail to test for fragrance mix 2 will miss about one-third of fragrance allergic contact dermatitis diagnoses. “If the distribution is scattered, you want to be suspicious for fragrance allergy,” Dr. de la Feld said. “Sometimes patients get exposed inadvertently by their significant other or by a family member who is spraying a fragrant product.” Treatment is avoidance. “You want to tell patients to look for products labeled as fragrance free,” she said. “ ‘Unscented’ does not count. When patients tell you that they’re not using any perfume, you want to ask them if they’ve put any on their clothes.”
Systemic contact dermatitis
Dr. de la Feld finished her presentation by discussing systemic contact dermatitis, which she defined as a rash from systemic exposure to an allergen in someone who was previously sensitized. Alternative names for the condition include endogenous contact eczema, systemically-induced contact dermatitis, and internal-external contact-type hypersensitivity. She acknowledged that not all dermatologists believe systemic contact dermatitis to be a true clinical condition, but she does.
“It’s most classically and commonly reported with nickel and balsam of Peru and more slowly with some other allergens,” she said. “It can have multiple clinical presentations, and it’s not always widespread.” The three most common presentations are dyshidrotic hand eczema, sites of prior contact dermatitis (from contact or patch test), and anogenital and/or flexural areas (Baboon syndrome). There are other reports of systemic contact dermatitis presenting as disseminated patchy dermatitis, generalized erythroderma, cheilitis, and lichen planus of the lip.
Dr. de la Feld reported having no relevant financial disclosures.
Correction, 3/28/17: In an earlier version of this article Dr. de la Feld's name was misstated in the photo caption.
ATLANTA – Formaldehyde has various clinical presentations and variable thresholds to trigger allergic contact dermatitis, so it requires a high index of suspicion, according to Salma de la Feld, MD.
It may present as irritant contact dermatitis, allergic contact dermatitis (especially to the hands and face), airborne allergic contact dermatitis, or systemic allergic contact dermatitis (to aspartame).
From most-releasing to least-releasing, these chemicals include quaternium-15, diazolidinyl urea, DMDM hydantoin, imidazolidinyl urea, and bronopol. Exposure can come from personal care products, prescription topical steroids and acne creams, Brazilian hair keratin, cigarettes, and textiles made of blended fabrics, as well as occupations such as a leather handler, surgical nurse, pathology lab worker, and hairdresser.
“Patients can be allergic to either the formaldehyde that [a product] releases or the non–formaldehyde component or both,” said Dr. de la Feld, who is a dermatologist at Emory University, Atlanta.
Recent studies suggest that the formaldehyde allergen should be tested at 2% instead of at 1%. “You do get a few more irritant reactions [with this approach], but you’re also going to catch more people who have a true positive reaction,” she said. “If you see a borderline papule with a little pink, that might be an irritant. You want to test for the formaldehyde releasers. When you do have a positive reaction, you want to have a high index of suspicion. Patients have to be strict in what personal care products they’re using. Some people might be able to tolerate a low concentration of formaldehyde in some products and that magic number differs between patients.”
From a treatment standpoint, Dr. de la Feld advises patients to avoid all formaldehyde releasers and to wear 100% fabrics in an effort to steer clear of textile exposure. “I like to have people be really strict [in their avoidance] when they’re first starting out,” she said. “They don’t like it, but I’ll say, ‘You’re so itchy. Let’s start really strict to get you clear and better.’ Once they’re better and there’s that one moisturizing cream that they really love, then [you] can do a repeat open application test. If nothing happens, it’s probably safe. If [they] start getting red and itchy there, [they] should probably throw away that moisturizer.”
Fragrance
Fragrance, which was named Allergen of the Year in 2007, is another common contact allergen. An estimated 4%-11% of the worldwide population is allergic to fragrance mix, while 1.6%-10.8% is allergic to balsam of Peru. T.R.U.E. tests for the allergen often yield false-negative results. Clinicians who fail to test for fragrance mix 2 will miss about one-third of fragrance allergic contact dermatitis diagnoses. “If the distribution is scattered, you want to be suspicious for fragrance allergy,” Dr. de la Feld said. “Sometimes patients get exposed inadvertently by their significant other or by a family member who is spraying a fragrant product.” Treatment is avoidance. “You want to tell patients to look for products labeled as fragrance free,” she said. “ ‘Unscented’ does not count. When patients tell you that they’re not using any perfume, you want to ask them if they’ve put any on their clothes.”
Systemic contact dermatitis
Dr. de la Feld finished her presentation by discussing systemic contact dermatitis, which she defined as a rash from systemic exposure to an allergen in someone who was previously sensitized. Alternative names for the condition include endogenous contact eczema, systemically-induced contact dermatitis, and internal-external contact-type hypersensitivity. She acknowledged that not all dermatologists believe systemic contact dermatitis to be a true clinical condition, but she does.
“It’s most classically and commonly reported with nickel and balsam of Peru and more slowly with some other allergens,” she said. “It can have multiple clinical presentations, and it’s not always widespread.” The three most common presentations are dyshidrotic hand eczema, sites of prior contact dermatitis (from contact or patch test), and anogenital and/or flexural areas (Baboon syndrome). There are other reports of systemic contact dermatitis presenting as disseminated patchy dermatitis, generalized erythroderma, cheilitis, and lichen planus of the lip.
Dr. de la Feld reported having no relevant financial disclosures.
Correction, 3/28/17: In an earlier version of this article Dr. de la Feld's name was misstated in the photo caption.
ATLANTA – Formaldehyde has various clinical presentations and variable thresholds to trigger allergic contact dermatitis, so it requires a high index of suspicion, according to Salma de la Feld, MD.
It may present as irritant contact dermatitis, allergic contact dermatitis (especially to the hands and face), airborne allergic contact dermatitis, or systemic allergic contact dermatitis (to aspartame).
From most-releasing to least-releasing, these chemicals include quaternium-15, diazolidinyl urea, DMDM hydantoin, imidazolidinyl urea, and bronopol. Exposure can come from personal care products, prescription topical steroids and acne creams, Brazilian hair keratin, cigarettes, and textiles made of blended fabrics, as well as occupations such as a leather handler, surgical nurse, pathology lab worker, and hairdresser.
“Patients can be allergic to either the formaldehyde that [a product] releases or the non–formaldehyde component or both,” said Dr. de la Feld, who is a dermatologist at Emory University, Atlanta.
Recent studies suggest that the formaldehyde allergen should be tested at 2% instead of at 1%. “You do get a few more irritant reactions [with this approach], but you’re also going to catch more people who have a true positive reaction,” she said. “If you see a borderline papule with a little pink, that might be an irritant. You want to test for the formaldehyde releasers. When you do have a positive reaction, you want to have a high index of suspicion. Patients have to be strict in what personal care products they’re using. Some people might be able to tolerate a low concentration of formaldehyde in some products and that magic number differs between patients.”
From a treatment standpoint, Dr. de la Feld advises patients to avoid all formaldehyde releasers and to wear 100% fabrics in an effort to steer clear of textile exposure. “I like to have people be really strict [in their avoidance] when they’re first starting out,” she said. “They don’t like it, but I’ll say, ‘You’re so itchy. Let’s start really strict to get you clear and better.’ Once they’re better and there’s that one moisturizing cream that they really love, then [you] can do a repeat open application test. If nothing happens, it’s probably safe. If [they] start getting red and itchy there, [they] should probably throw away that moisturizer.”
Fragrance
Fragrance, which was named Allergen of the Year in 2007, is another common contact allergen. An estimated 4%-11% of the worldwide population is allergic to fragrance mix, while 1.6%-10.8% is allergic to balsam of Peru. T.R.U.E. tests for the allergen often yield false-negative results. Clinicians who fail to test for fragrance mix 2 will miss about one-third of fragrance allergic contact dermatitis diagnoses. “If the distribution is scattered, you want to be suspicious for fragrance allergy,” Dr. de la Feld said. “Sometimes patients get exposed inadvertently by their significant other or by a family member who is spraying a fragrant product.” Treatment is avoidance. “You want to tell patients to look for products labeled as fragrance free,” she said. “ ‘Unscented’ does not count. When patients tell you that they’re not using any perfume, you want to ask them if they’ve put any on their clothes.”
Systemic contact dermatitis
Dr. de la Feld finished her presentation by discussing systemic contact dermatitis, which she defined as a rash from systemic exposure to an allergen in someone who was previously sensitized. Alternative names for the condition include endogenous contact eczema, systemically-induced contact dermatitis, and internal-external contact-type hypersensitivity. She acknowledged that not all dermatologists believe systemic contact dermatitis to be a true clinical condition, but she does.
“It’s most classically and commonly reported with nickel and balsam of Peru and more slowly with some other allergens,” she said. “It can have multiple clinical presentations, and it’s not always widespread.” The three most common presentations are dyshidrotic hand eczema, sites of prior contact dermatitis (from contact or patch test), and anogenital and/or flexural areas (Baboon syndrome). There are other reports of systemic contact dermatitis presenting as disseminated patchy dermatitis, generalized erythroderma, cheilitis, and lichen planus of the lip.
Dr. de la Feld reported having no relevant financial disclosures.
Correction, 3/28/17: In an earlier version of this article Dr. de la Feld's name was misstated in the photo caption.
EXPERT ANALYSIS AT THE 2017 AAAAI ANNUAL MEETING