Pediatric OSA linked to abnormal metabolic values

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– Obstructive sleep apnea (OSA) in children is associated with an abnormal metabolic profile, but not with body mass index (BMI), according to new research.

Tara Haelle/MDedge News
Dr. Kanika Mathur

“Screening for metabolic dysfunction in obese children with obstructive sleep apnea can help identify those at risk for cardiovascular complications,” Kanika Mathur, MD, of the Albert Einstein College of Medicine and the Children’s Hospital at Montefiore, both in New York, told attendees at the annual meeting of the American College of Chest Physicians. Dr. Mathur explained that no consensus currently exists regarding routine cardiac evaluation of children with OSA.

“The American Academy of Pediatrics does not mention any sort of cardiac evaluation in children with OSA while the most recent guidelines from the American Heart Association and the American Thoracic Society recommend echocardiographic evaluation in children with severe obstructive sleep apnea, specifically to evaluate for pulmonary hypertension and right ventricular dysfunction,” Dr. Mathur told attendees.

OSA’s association with obesity, diabetes, and hypertension is well established in adults. It is an independent risk factor for coronary artery disease, heart failure, stroke and atrial fibrillation, and research has suggested OSA treatment can reduce cardiovascular risk in adults, Dr. Mathur explained, but little data on children exist. She and her colleagues set out to understand the relationship of OSA in children with various measures of cardiovascular and metabolic health.

“Despite similar degrees of obesity and systemic blood pressure, pediatric patients with OSA had significantly higher diastolic blood pressure, heart rate, and abnormal metabolic profile, including elevated alanine transaminase, aspartate transaminase, triglycerides and hemoglobin A1c,” they found.

Their study included patients aged 3-21 years with a BMI of at least the 95th percentile who had undergone sleep study and an echocardiogram at the Children’s Hospital at Montefiore between November 2016 and November 2017.

They excluded those with comorbidities related to cardiovascular morbidity: heart disease, neuromuscular disease, sickle cell disease, rheumatologic diseases, significant cranial facial abnormalities, tracheostomy, and any lung disease. However, 7% of the patients had trisomy 21.

Among the 81 children who met their criteria, 37 were male and 44 were female, with an average age of 14 years old and a mean BMI of 39.4 kg/m2 (mean BMI z score of 2.22). Most of the patients (53.1%) had severe OSA (apnea-hypopnea index of at least 10), 21% had moderate OSA (AHI 5-9.9), 12.3% had mild OSA (AHI 2-4.9), and 13.6% did not have OSA. The median AHI of the children was 10.3.

Among all the children, “about half had elevated systolic blood pressure, which is already a risk factor for cardiovascular morbidity,” Mathur reported.

BMI, BMI z score, systolic blood pressure z score, oxygen saturation and cholesterol (overall and both HDL and LDL cholesterol levels) did not significantly differ between children who had OSA and those who did not, but diastolic blood pressure and heart rate did. Those with OSA had a diastolic blood pressure of 65 mm Hg, compared with 58 mm Hg without OSA (P = .008). Heart rate was 89 bpm in the children with OSA, compared with 78 bpm in those without (P = .004).

The children with OSA also showed higher mean levels of several other metabolic biomarkers:

 

 

  • Alanine transaminase: 26 U/L with OSA vs. 18 U/L without (P = .01).
  • Aspartate transaminase: 23 U/L with OSA vs. 18 U/L without (P = .03).
  • Triglycerides: 138 mg/dL with OSA vs 84 mg/dL without (P = .004).
  • Hemoglobin A1c: 6.2% with OSA vs. 5.4% without (P = .002).

Children with and without OSA did not have any significant differences in left atrial indexed volume, left ventricular volume, left ventricular ejection fraction, or left ventricular mass (measured by M-mode or 5/6 area length formula). Though research has shown these measures to differ in adults with and without OSA, evidence on echocardiographic changes in children has been conflicting, Dr. Mathur noted.

The researchers also conducted subanalyses according to OSA severity, but BMI, BMI Z-score, systolic or diastolic blood pressure Z-score, heart rate and oxygen saturation did not differ between those with mild OSA vs those with moderate or severe OSA. No differences in echocardiographic measurements existed between these subgroups, either.

However, children with moderate to severe OSA did have higher alanine transaminase (27 U/L with moderate to severe vs. 17 U/L with mild OSA; P = .005) and higher triglycerides (148 vs 74; P = .001).

“Certainly we need further evaluation to see the efficacy of obstructive sleep apnea therapies on metabolic dysfunction and whether weight loss needs to be an adjunct therapy for these patients,” Dr. Mathur told attendees. She also noted the need to define the role of echocardiography in managing children with OSA.

The study had several limitations, including its retrospective cross-sectional nature at a single center and its small sample size.

Andrew D. Bowser/MDedge News
Dr. Shahid Sheikh

“Additionally, we have a wide variety of ages, which could represent different pathophysiology of the associated metabolic dysfunction in these patients,” Mathur said. “There is an inherent difficulty to performing echocardiograms in a very obese population as well.”

Both the moderators of the pediatrics section, Christopher Carroll, MD, FCCP, of Connecticut Children’s Medical Center in Hartford, and Shahid Sheikh, MD, FCCP, of Nationwide Children’s Hospital in Columbus, Ohio, were impressed with the research. Dr. Carroll called it a “very elegant” study, and Dr. Sheikh noted the need for these studies in pediatrics “so that we don’t have to rely on grown-up data,” which may or may not generalize to children.

SOURCE: CHEST 2018. https://journal.chestnet.org/article/S0012-3692(18)31935-4/fulltext

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– Obstructive sleep apnea (OSA) in children is associated with an abnormal metabolic profile, but not with body mass index (BMI), according to new research.

Tara Haelle/MDedge News
Dr. Kanika Mathur

“Screening for metabolic dysfunction in obese children with obstructive sleep apnea can help identify those at risk for cardiovascular complications,” Kanika Mathur, MD, of the Albert Einstein College of Medicine and the Children’s Hospital at Montefiore, both in New York, told attendees at the annual meeting of the American College of Chest Physicians. Dr. Mathur explained that no consensus currently exists regarding routine cardiac evaluation of children with OSA.

“The American Academy of Pediatrics does not mention any sort of cardiac evaluation in children with OSA while the most recent guidelines from the American Heart Association and the American Thoracic Society recommend echocardiographic evaluation in children with severe obstructive sleep apnea, specifically to evaluate for pulmonary hypertension and right ventricular dysfunction,” Dr. Mathur told attendees.

OSA’s association with obesity, diabetes, and hypertension is well established in adults. It is an independent risk factor for coronary artery disease, heart failure, stroke and atrial fibrillation, and research has suggested OSA treatment can reduce cardiovascular risk in adults, Dr. Mathur explained, but little data on children exist. She and her colleagues set out to understand the relationship of OSA in children with various measures of cardiovascular and metabolic health.

“Despite similar degrees of obesity and systemic blood pressure, pediatric patients with OSA had significantly higher diastolic blood pressure, heart rate, and abnormal metabolic profile, including elevated alanine transaminase, aspartate transaminase, triglycerides and hemoglobin A1c,” they found.

Their study included patients aged 3-21 years with a BMI of at least the 95th percentile who had undergone sleep study and an echocardiogram at the Children’s Hospital at Montefiore between November 2016 and November 2017.

They excluded those with comorbidities related to cardiovascular morbidity: heart disease, neuromuscular disease, sickle cell disease, rheumatologic diseases, significant cranial facial abnormalities, tracheostomy, and any lung disease. However, 7% of the patients had trisomy 21.

Among the 81 children who met their criteria, 37 were male and 44 were female, with an average age of 14 years old and a mean BMI of 39.4 kg/m2 (mean BMI z score of 2.22). Most of the patients (53.1%) had severe OSA (apnea-hypopnea index of at least 10), 21% had moderate OSA (AHI 5-9.9), 12.3% had mild OSA (AHI 2-4.9), and 13.6% did not have OSA. The median AHI of the children was 10.3.

Among all the children, “about half had elevated systolic blood pressure, which is already a risk factor for cardiovascular morbidity,” Mathur reported.

BMI, BMI z score, systolic blood pressure z score, oxygen saturation and cholesterol (overall and both HDL and LDL cholesterol levels) did not significantly differ between children who had OSA and those who did not, but diastolic blood pressure and heart rate did. Those with OSA had a diastolic blood pressure of 65 mm Hg, compared with 58 mm Hg without OSA (P = .008). Heart rate was 89 bpm in the children with OSA, compared with 78 bpm in those without (P = .004).

The children with OSA also showed higher mean levels of several other metabolic biomarkers:

 

 

  • Alanine transaminase: 26 U/L with OSA vs. 18 U/L without (P = .01).
  • Aspartate transaminase: 23 U/L with OSA vs. 18 U/L without (P = .03).
  • Triglycerides: 138 mg/dL with OSA vs 84 mg/dL without (P = .004).
  • Hemoglobin A1c: 6.2% with OSA vs. 5.4% without (P = .002).

Children with and without OSA did not have any significant differences in left atrial indexed volume, left ventricular volume, left ventricular ejection fraction, or left ventricular mass (measured by M-mode or 5/6 area length formula). Though research has shown these measures to differ in adults with and without OSA, evidence on echocardiographic changes in children has been conflicting, Dr. Mathur noted.

The researchers also conducted subanalyses according to OSA severity, but BMI, BMI Z-score, systolic or diastolic blood pressure Z-score, heart rate and oxygen saturation did not differ between those with mild OSA vs those with moderate or severe OSA. No differences in echocardiographic measurements existed between these subgroups, either.

However, children with moderate to severe OSA did have higher alanine transaminase (27 U/L with moderate to severe vs. 17 U/L with mild OSA; P = .005) and higher triglycerides (148 vs 74; P = .001).

“Certainly we need further evaluation to see the efficacy of obstructive sleep apnea therapies on metabolic dysfunction and whether weight loss needs to be an adjunct therapy for these patients,” Dr. Mathur told attendees. She also noted the need to define the role of echocardiography in managing children with OSA.

The study had several limitations, including its retrospective cross-sectional nature at a single center and its small sample size.

Andrew D. Bowser/MDedge News
Dr. Shahid Sheikh

“Additionally, we have a wide variety of ages, which could represent different pathophysiology of the associated metabolic dysfunction in these patients,” Mathur said. “There is an inherent difficulty to performing echocardiograms in a very obese population as well.”

Both the moderators of the pediatrics section, Christopher Carroll, MD, FCCP, of Connecticut Children’s Medical Center in Hartford, and Shahid Sheikh, MD, FCCP, of Nationwide Children’s Hospital in Columbus, Ohio, were impressed with the research. Dr. Carroll called it a “very elegant” study, and Dr. Sheikh noted the need for these studies in pediatrics “so that we don’t have to rely on grown-up data,” which may or may not generalize to children.

SOURCE: CHEST 2018. https://journal.chestnet.org/article/S0012-3692(18)31935-4/fulltext

 

– Obstructive sleep apnea (OSA) in children is associated with an abnormal metabolic profile, but not with body mass index (BMI), according to new research.

Tara Haelle/MDedge News
Dr. Kanika Mathur

“Screening for metabolic dysfunction in obese children with obstructive sleep apnea can help identify those at risk for cardiovascular complications,” Kanika Mathur, MD, of the Albert Einstein College of Medicine and the Children’s Hospital at Montefiore, both in New York, told attendees at the annual meeting of the American College of Chest Physicians. Dr. Mathur explained that no consensus currently exists regarding routine cardiac evaluation of children with OSA.

“The American Academy of Pediatrics does not mention any sort of cardiac evaluation in children with OSA while the most recent guidelines from the American Heart Association and the American Thoracic Society recommend echocardiographic evaluation in children with severe obstructive sleep apnea, specifically to evaluate for pulmonary hypertension and right ventricular dysfunction,” Dr. Mathur told attendees.

OSA’s association with obesity, diabetes, and hypertension is well established in adults. It is an independent risk factor for coronary artery disease, heart failure, stroke and atrial fibrillation, and research has suggested OSA treatment can reduce cardiovascular risk in adults, Dr. Mathur explained, but little data on children exist. She and her colleagues set out to understand the relationship of OSA in children with various measures of cardiovascular and metabolic health.

“Despite similar degrees of obesity and systemic blood pressure, pediatric patients with OSA had significantly higher diastolic blood pressure, heart rate, and abnormal metabolic profile, including elevated alanine transaminase, aspartate transaminase, triglycerides and hemoglobin A1c,” they found.

Their study included patients aged 3-21 years with a BMI of at least the 95th percentile who had undergone sleep study and an echocardiogram at the Children’s Hospital at Montefiore between November 2016 and November 2017.

They excluded those with comorbidities related to cardiovascular morbidity: heart disease, neuromuscular disease, sickle cell disease, rheumatologic diseases, significant cranial facial abnormalities, tracheostomy, and any lung disease. However, 7% of the patients had trisomy 21.

Among the 81 children who met their criteria, 37 were male and 44 were female, with an average age of 14 years old and a mean BMI of 39.4 kg/m2 (mean BMI z score of 2.22). Most of the patients (53.1%) had severe OSA (apnea-hypopnea index of at least 10), 21% had moderate OSA (AHI 5-9.9), 12.3% had mild OSA (AHI 2-4.9), and 13.6% did not have OSA. The median AHI of the children was 10.3.

Among all the children, “about half had elevated systolic blood pressure, which is already a risk factor for cardiovascular morbidity,” Mathur reported.

BMI, BMI z score, systolic blood pressure z score, oxygen saturation and cholesterol (overall and both HDL and LDL cholesterol levels) did not significantly differ between children who had OSA and those who did not, but diastolic blood pressure and heart rate did. Those with OSA had a diastolic blood pressure of 65 mm Hg, compared with 58 mm Hg without OSA (P = .008). Heart rate was 89 bpm in the children with OSA, compared with 78 bpm in those without (P = .004).

The children with OSA also showed higher mean levels of several other metabolic biomarkers:

 

 

  • Alanine transaminase: 26 U/L with OSA vs. 18 U/L without (P = .01).
  • Aspartate transaminase: 23 U/L with OSA vs. 18 U/L without (P = .03).
  • Triglycerides: 138 mg/dL with OSA vs 84 mg/dL without (P = .004).
  • Hemoglobin A1c: 6.2% with OSA vs. 5.4% without (P = .002).

Children with and without OSA did not have any significant differences in left atrial indexed volume, left ventricular volume, left ventricular ejection fraction, or left ventricular mass (measured by M-mode or 5/6 area length formula). Though research has shown these measures to differ in adults with and without OSA, evidence on echocardiographic changes in children has been conflicting, Dr. Mathur noted.

The researchers also conducted subanalyses according to OSA severity, but BMI, BMI Z-score, systolic or diastolic blood pressure Z-score, heart rate and oxygen saturation did not differ between those with mild OSA vs those with moderate or severe OSA. No differences in echocardiographic measurements existed between these subgroups, either.

However, children with moderate to severe OSA did have higher alanine transaminase (27 U/L with moderate to severe vs. 17 U/L with mild OSA; P = .005) and higher triglycerides (148 vs 74; P = .001).

“Certainly we need further evaluation to see the efficacy of obstructive sleep apnea therapies on metabolic dysfunction and whether weight loss needs to be an adjunct therapy for these patients,” Dr. Mathur told attendees. She also noted the need to define the role of echocardiography in managing children with OSA.

The study had several limitations, including its retrospective cross-sectional nature at a single center and its small sample size.

Andrew D. Bowser/MDedge News
Dr. Shahid Sheikh

“Additionally, we have a wide variety of ages, which could represent different pathophysiology of the associated metabolic dysfunction in these patients,” Mathur said. “There is an inherent difficulty to performing echocardiograms in a very obese population as well.”

Both the moderators of the pediatrics section, Christopher Carroll, MD, FCCP, of Connecticut Children’s Medical Center in Hartford, and Shahid Sheikh, MD, FCCP, of Nationwide Children’s Hospital in Columbus, Ohio, were impressed with the research. Dr. Carroll called it a “very elegant” study, and Dr. Sheikh noted the need for these studies in pediatrics “so that we don’t have to rely on grown-up data,” which may or may not generalize to children.

SOURCE: CHEST 2018. https://journal.chestnet.org/article/S0012-3692(18)31935-4/fulltext

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Key clinical point: Children with obesity and obstructive sleep apnea have an abnormal metabolic profile.

Major finding: Diastolic blood pressure (65 vs. 58 mm Hg), heart rate (89 vs. 78 bpm), triglycerides (138 vs. 84 mg/dL), alanine transaminase (26 vs. 18 U/L), aspartate transaminase (23 vs. 18 U/L) and hemoglobin A1c (6.2% vs. 5.4%) were all elevated in obese children with OSA, compared with obese children without OSA.

Study details: The findings are based on a retrospective analysis of 81 patients aged 3-21 years, from the Children’s Hospital at Montefiore between November 2016-November 2017.

Disclosures: No external funding was noted. The authors reported having no disclosures.

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Rising microbiome investigator: Ting-Chin David Shen, MD, PhD

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We spoke with Dr. Shen, instructor of medicine at the University of Pennsylvania and the recipient of the AGA Research Foundation’s 2016 Microbiome Junior Investigator Award, to learn about his passion for gut microbiome research.

How would you sum up your research in one sentence?

Dr. Ting-Chin D. Shen

My research examines the metabolic interactions between the gut microbiota and the mammalian host, with a particular emphasis on amino acid metabolism and nitrogen flux via the bacterial enzyme urease.

What impact do you hope your research will have on patients?

My hope is that by better understanding the biological mechanisms by which the gut microbiota impacts host metabolism, we can modulate its effects to treat a variety of conditions and diseases including hepatic encephalopathy, inborn errors of metabolism, obesity, malnutrition, etc.

What inspired you to focus your research career on the gut microbiome?

My clinical experience as a gastroenterologist inspired my interest in metabolic and nutritional research. When I learned of the impact that the gut microbiota has on host metabolism, it created an entirely different perspective for me in terms of thinking about how to treat metabolic and nutritional disorders. There are tremendous opportunities in modifying our gut microbiota in concert with dietary interventions in order to modulate our metabolism.

What recent publication from your lab best represents your work, if anyone wants to learn more?

The following work examined how the use of a defined bacterial consortium without urease activity can reduce colonic ammonia level upon inoculation into the gut and ameliorate morbidity and mortality in a murine model of liver disease.

Shen, T.D., Albenberg, L.A., Bittinger, K., et al, Engineering the Gut Microbiota to Treat Hyperammonemia. Journal of Clinical Investigation. 2015 Jul 1;125(7):2841-50.

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We spoke with Dr. Shen, instructor of medicine at the University of Pennsylvania and the recipient of the AGA Research Foundation’s 2016 Microbiome Junior Investigator Award, to learn about his passion for gut microbiome research.

How would you sum up your research in one sentence?

Dr. Ting-Chin D. Shen

My research examines the metabolic interactions between the gut microbiota and the mammalian host, with a particular emphasis on amino acid metabolism and nitrogen flux via the bacterial enzyme urease.

What impact do you hope your research will have on patients?

My hope is that by better understanding the biological mechanisms by which the gut microbiota impacts host metabolism, we can modulate its effects to treat a variety of conditions and diseases including hepatic encephalopathy, inborn errors of metabolism, obesity, malnutrition, etc.

What inspired you to focus your research career on the gut microbiome?

My clinical experience as a gastroenterologist inspired my interest in metabolic and nutritional research. When I learned of the impact that the gut microbiota has on host metabolism, it created an entirely different perspective for me in terms of thinking about how to treat metabolic and nutritional disorders. There are tremendous opportunities in modifying our gut microbiota in concert with dietary interventions in order to modulate our metabolism.

What recent publication from your lab best represents your work, if anyone wants to learn more?

The following work examined how the use of a defined bacterial consortium without urease activity can reduce colonic ammonia level upon inoculation into the gut and ameliorate morbidity and mortality in a murine model of liver disease.

Shen, T.D., Albenberg, L.A., Bittinger, K., et al, Engineering the Gut Microbiota to Treat Hyperammonemia. Journal of Clinical Investigation. 2015 Jul 1;125(7):2841-50.

We spoke with Dr. Shen, instructor of medicine at the University of Pennsylvania and the recipient of the AGA Research Foundation’s 2016 Microbiome Junior Investigator Award, to learn about his passion for gut microbiome research.

How would you sum up your research in one sentence?

Dr. Ting-Chin D. Shen

My research examines the metabolic interactions between the gut microbiota and the mammalian host, with a particular emphasis on amino acid metabolism and nitrogen flux via the bacterial enzyme urease.

What impact do you hope your research will have on patients?

My hope is that by better understanding the biological mechanisms by which the gut microbiota impacts host metabolism, we can modulate its effects to treat a variety of conditions and diseases including hepatic encephalopathy, inborn errors of metabolism, obesity, malnutrition, etc.

What inspired you to focus your research career on the gut microbiome?

My clinical experience as a gastroenterologist inspired my interest in metabolic and nutritional research. When I learned of the impact that the gut microbiota has on host metabolism, it created an entirely different perspective for me in terms of thinking about how to treat metabolic and nutritional disorders. There are tremendous opportunities in modifying our gut microbiota in concert with dietary interventions in order to modulate our metabolism.

What recent publication from your lab best represents your work, if anyone wants to learn more?

The following work examined how the use of a defined bacterial consortium without urease activity can reduce colonic ammonia level upon inoculation into the gut and ameliorate morbidity and mortality in a murine model of liver disease.

Shen, T.D., Albenberg, L.A., Bittinger, K., et al, Engineering the Gut Microbiota to Treat Hyperammonemia. Journal of Clinical Investigation. 2015 Jul 1;125(7):2841-50.

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AGA’s flagship research grant now accepting applications

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The call for applications for 2019 Research Scholar Awards (RSA) is now open. An RSA enables young investigators to develop independent and productive research careers by ensuring protected time for research. And our commitment includes supporting the career development of all GI researchers, whether they focus on clinical or basic research. The deadline to apply is Dec. 14, 2018.

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The call for applications for 2019 Research Scholar Awards (RSA) is now open. An RSA enables young investigators to develop independent and productive research careers by ensuring protected time for research. And our commitment includes supporting the career development of all GI researchers, whether they focus on clinical or basic research. The deadline to apply is Dec. 14, 2018.

The call for applications for 2019 Research Scholar Awards (RSA) is now open. An RSA enables young investigators to develop independent and productive research careers by ensuring protected time for research. And our commitment includes supporting the career development of all GI researchers, whether they focus on clinical or basic research. The deadline to apply is Dec. 14, 2018.

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Smart insoles reduce ‘high-risk’ diabetic foot ulcer recurrence

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BERLIN – Smart insoles that warn diabetic individuals of high plantar pressures could be a simple solution to help them avoid recurrent foot ulcers, according to the results of a randomized trial.

Study participants with a history of diabetic foot ulcers wore the plantar pressure–sensing insoles (SurroSense Rx) and received feedback via sensor linked to a smart watch worn and were 71% less likely to experience a recurrent foot ulceration than were those who wore the insoles but did not get the pressure feedback (incidence rate ratio, 0.29; 95% confidence interval, 0.09-0.93; P = .037). The device has been cleared by the Food and Drug Administration.

Overall, there were few ulcers that occurred in the study, with 10 ulcers from 8,638 person-days from six patients reported in the control group and four ulcers from 11,835 person-days from four patients in the intervention group.

“Diabetic foot ulcers are a major global health and economic burden, but, in theory at least, they are ultimately preventable,” said study investigator Neil Reeves, PhD,, who presented the findings at the annual meeting of the European Association for the Study of Diabetes.

Data suggest that recurrence rates for ulceration are as high as 65% at 6 years, he said, with up to a quarter of ulcers progressing to the point where some form of amputation is needed.

“In the laboratory, we can measure plantar pressures, and these are considered as a relatively accurate proxy for diabetic foot ulcer risk. So we can discriminate between those with diabetic neuropathy, and those without, and also those with a previous history of ulceration,” Dr. Reeves said.

Dr. Reeves, who is professor of musculoskeletal biomechanics at Manchester (England) Metropolitan University, observed that the rationale behind the development of the smart insoles was to move plantar pressure measurement out of the laboratory and into the real world.

The smart insoles incorporate eight discreet pressure sensors that are connected to pod worn on the front of the participant’s own shoe and that wirelessly relay pressure information to a smartwatch. Both the control and the intervention groups received the same device, Dr. Reeves pointed out, but the difference was that the only the intervention group got any pressure feedback from the sensors to the smartwatch.

“When high pressure was experienced in the intervention group on any of these sensors, the patient was alerted both by an auditory alarm and also by being able to see this on the smartwatch,” Dr. Reeves explained.

“The patient would be alerted as to where the pressure was high on the foot and that would be a trigger to offload this high pressure.” Patients would then be instructed via the smartwatch to try to offload the pressure by either walking around for 2 minutes, actively taking the weight off the foot, or removing the shoe to check for any foreign bodies.

In all, there were 58 study participants – 32 randomized to the intervention group and 26 to the control group – who had a history of diabetic foot ulcers and peripheral neuropathy but who were able to walk independently for at least 30 steps. The mean age of patients in the intervention group was 59 years, 88% were male, 72% had type 2 diabetes mellitus, with the mean duration of diabetes was 22 years. Corresponding data in the control group were 67 years, 89% male, 85% had type 2 diabetes, and 21 years’ diabetes duration.

Patients were reviewed monthly over a period of 18 months or until plantar ulceration occurred. Information on diabetic foot ulcers was collected and standardized using a previously developed mobile app (Diabetes Sci Technol. 2018;12[1]:169-73) and then confirmed via blinded assessment by two experts.

Dr. Reeves noted that there was no significant difference in the time to ulceration between the groups, with 77.5% and 68.4% of the intervention and control group remaining ulcer free at 18 months (P = .30). When the data were adjusted for compliance, there was an 86% reduction in the risk of reulceration in the intervention versus the control group (IRR, 0.14; 95% CI, 0.03-0.63; P = .011). This analysis took into account only those study participants who had 4.5 hours or more of daily wear of the smart insoles (n = 40). On average, the insoles were worn for 6.1 hours in the control group and by 6.9 hours in the intervention group.

“We suggest that the mechanism for this beneficial effect in the present study is likely pressure offloading, which has been afforded by providing patients in the intervention group with this plantar-pressure feedback,” said Dr. Reeves.

“That’s feedback that they’ve lost naturally many years ago due to diabetic peripheral neuropathy,” he added. “So, in that respect, we would suggest that patients have really been empowered here to take control of their foot health in a way that they haven’t been able to since the onset of significant diabetic peripheral neuropathy.”

Diabetes UK provided the primary funding for the study (years 1-3), with Orpyx Medical Technologies, Canada, providing funding during the study extension (year 4). Dr. Reeves did not have any disclosures.
 

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BERLIN – Smart insoles that warn diabetic individuals of high plantar pressures could be a simple solution to help them avoid recurrent foot ulcers, according to the results of a randomized trial.

Study participants with a history of diabetic foot ulcers wore the plantar pressure–sensing insoles (SurroSense Rx) and received feedback via sensor linked to a smart watch worn and were 71% less likely to experience a recurrent foot ulceration than were those who wore the insoles but did not get the pressure feedback (incidence rate ratio, 0.29; 95% confidence interval, 0.09-0.93; P = .037). The device has been cleared by the Food and Drug Administration.

Overall, there were few ulcers that occurred in the study, with 10 ulcers from 8,638 person-days from six patients reported in the control group and four ulcers from 11,835 person-days from four patients in the intervention group.

“Diabetic foot ulcers are a major global health and economic burden, but, in theory at least, they are ultimately preventable,” said study investigator Neil Reeves, PhD,, who presented the findings at the annual meeting of the European Association for the Study of Diabetes.

Data suggest that recurrence rates for ulceration are as high as 65% at 6 years, he said, with up to a quarter of ulcers progressing to the point where some form of amputation is needed.

“In the laboratory, we can measure plantar pressures, and these are considered as a relatively accurate proxy for diabetic foot ulcer risk. So we can discriminate between those with diabetic neuropathy, and those without, and also those with a previous history of ulceration,” Dr. Reeves said.

Dr. Reeves, who is professor of musculoskeletal biomechanics at Manchester (England) Metropolitan University, observed that the rationale behind the development of the smart insoles was to move plantar pressure measurement out of the laboratory and into the real world.

The smart insoles incorporate eight discreet pressure sensors that are connected to pod worn on the front of the participant’s own shoe and that wirelessly relay pressure information to a smartwatch. Both the control and the intervention groups received the same device, Dr. Reeves pointed out, but the difference was that the only the intervention group got any pressure feedback from the sensors to the smartwatch.

“When high pressure was experienced in the intervention group on any of these sensors, the patient was alerted both by an auditory alarm and also by being able to see this on the smartwatch,” Dr. Reeves explained.

“The patient would be alerted as to where the pressure was high on the foot and that would be a trigger to offload this high pressure.” Patients would then be instructed via the smartwatch to try to offload the pressure by either walking around for 2 minutes, actively taking the weight off the foot, or removing the shoe to check for any foreign bodies.

In all, there were 58 study participants – 32 randomized to the intervention group and 26 to the control group – who had a history of diabetic foot ulcers and peripheral neuropathy but who were able to walk independently for at least 30 steps. The mean age of patients in the intervention group was 59 years, 88% were male, 72% had type 2 diabetes mellitus, with the mean duration of diabetes was 22 years. Corresponding data in the control group were 67 years, 89% male, 85% had type 2 diabetes, and 21 years’ diabetes duration.

Patients were reviewed monthly over a period of 18 months or until plantar ulceration occurred. Information on diabetic foot ulcers was collected and standardized using a previously developed mobile app (Diabetes Sci Technol. 2018;12[1]:169-73) and then confirmed via blinded assessment by two experts.

Dr. Reeves noted that there was no significant difference in the time to ulceration between the groups, with 77.5% and 68.4% of the intervention and control group remaining ulcer free at 18 months (P = .30). When the data were adjusted for compliance, there was an 86% reduction in the risk of reulceration in the intervention versus the control group (IRR, 0.14; 95% CI, 0.03-0.63; P = .011). This analysis took into account only those study participants who had 4.5 hours or more of daily wear of the smart insoles (n = 40). On average, the insoles were worn for 6.1 hours in the control group and by 6.9 hours in the intervention group.

“We suggest that the mechanism for this beneficial effect in the present study is likely pressure offloading, which has been afforded by providing patients in the intervention group with this plantar-pressure feedback,” said Dr. Reeves.

“That’s feedback that they’ve lost naturally many years ago due to diabetic peripheral neuropathy,” he added. “So, in that respect, we would suggest that patients have really been empowered here to take control of their foot health in a way that they haven’t been able to since the onset of significant diabetic peripheral neuropathy.”

Diabetes UK provided the primary funding for the study (years 1-3), with Orpyx Medical Technologies, Canada, providing funding during the study extension (year 4). Dr. Reeves did not have any disclosures.
 

 

BERLIN – Smart insoles that warn diabetic individuals of high plantar pressures could be a simple solution to help them avoid recurrent foot ulcers, according to the results of a randomized trial.

Study participants with a history of diabetic foot ulcers wore the plantar pressure–sensing insoles (SurroSense Rx) and received feedback via sensor linked to a smart watch worn and were 71% less likely to experience a recurrent foot ulceration than were those who wore the insoles but did not get the pressure feedback (incidence rate ratio, 0.29; 95% confidence interval, 0.09-0.93; P = .037). The device has been cleared by the Food and Drug Administration.

Overall, there were few ulcers that occurred in the study, with 10 ulcers from 8,638 person-days from six patients reported in the control group and four ulcers from 11,835 person-days from four patients in the intervention group.

“Diabetic foot ulcers are a major global health and economic burden, but, in theory at least, they are ultimately preventable,” said study investigator Neil Reeves, PhD,, who presented the findings at the annual meeting of the European Association for the Study of Diabetes.

Data suggest that recurrence rates for ulceration are as high as 65% at 6 years, he said, with up to a quarter of ulcers progressing to the point where some form of amputation is needed.

“In the laboratory, we can measure plantar pressures, and these are considered as a relatively accurate proxy for diabetic foot ulcer risk. So we can discriminate between those with diabetic neuropathy, and those without, and also those with a previous history of ulceration,” Dr. Reeves said.

Dr. Reeves, who is professor of musculoskeletal biomechanics at Manchester (England) Metropolitan University, observed that the rationale behind the development of the smart insoles was to move plantar pressure measurement out of the laboratory and into the real world.

The smart insoles incorporate eight discreet pressure sensors that are connected to pod worn on the front of the participant’s own shoe and that wirelessly relay pressure information to a smartwatch. Both the control and the intervention groups received the same device, Dr. Reeves pointed out, but the difference was that the only the intervention group got any pressure feedback from the sensors to the smartwatch.

“When high pressure was experienced in the intervention group on any of these sensors, the patient was alerted both by an auditory alarm and also by being able to see this on the smartwatch,” Dr. Reeves explained.

“The patient would be alerted as to where the pressure was high on the foot and that would be a trigger to offload this high pressure.” Patients would then be instructed via the smartwatch to try to offload the pressure by either walking around for 2 minutes, actively taking the weight off the foot, or removing the shoe to check for any foreign bodies.

In all, there were 58 study participants – 32 randomized to the intervention group and 26 to the control group – who had a history of diabetic foot ulcers and peripheral neuropathy but who were able to walk independently for at least 30 steps. The mean age of patients in the intervention group was 59 years, 88% were male, 72% had type 2 diabetes mellitus, with the mean duration of diabetes was 22 years. Corresponding data in the control group were 67 years, 89% male, 85% had type 2 diabetes, and 21 years’ diabetes duration.

Patients were reviewed monthly over a period of 18 months or until plantar ulceration occurred. Information on diabetic foot ulcers was collected and standardized using a previously developed mobile app (Diabetes Sci Technol. 2018;12[1]:169-73) and then confirmed via blinded assessment by two experts.

Dr. Reeves noted that there was no significant difference in the time to ulceration between the groups, with 77.5% and 68.4% of the intervention and control group remaining ulcer free at 18 months (P = .30). When the data were adjusted for compliance, there was an 86% reduction in the risk of reulceration in the intervention versus the control group (IRR, 0.14; 95% CI, 0.03-0.63; P = .011). This analysis took into account only those study participants who had 4.5 hours or more of daily wear of the smart insoles (n = 40). On average, the insoles were worn for 6.1 hours in the control group and by 6.9 hours in the intervention group.

“We suggest that the mechanism for this beneficial effect in the present study is likely pressure offloading, which has been afforded by providing patients in the intervention group with this plantar-pressure feedback,” said Dr. Reeves.

“That’s feedback that they’ve lost naturally many years ago due to diabetic peripheral neuropathy,” he added. “So, in that respect, we would suggest that patients have really been empowered here to take control of their foot health in a way that they haven’t been able to since the onset of significant diabetic peripheral neuropathy.”

Diabetes UK provided the primary funding for the study (years 1-3), with Orpyx Medical Technologies, Canada, providing funding during the study extension (year 4). Dr. Reeves did not have any disclosures.
 

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Key clinical point: Pressure-sensing smart insoles could help warn “high-risk” individuals to offload excess pressure on their feet.

Major finding: A 71% reduction in the risk of reulceration was observed when compared with the intervention with the control group (P = .037).

Study details: Randomized, single-blind controlled randomized study of 58 adults with a history of plantar diabetic foot ulcers.

Disclosures: Diabetes UK provided the primary funding for the study (years 1-3), with Orpyx Medical Technologies providing funding during the study extension (year 4). Dr. Reeves did not have any disclosures.

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Highlights From ECTRIMS 2018

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Netflix addiction, COPD blues, waistline-busting memes

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The hottest new drug? Netflix

selimaksan/E+

We all knew this was coming eventually. The first case of “Netflix addiction” has emerged, as a 26-year-old man in India has reportedly sought help at an addiction treatment center in Bangalore. Symptoms included 7-10 hours of TV watching per day and increasing isolation from others. Honestly, sounds like an ideal weekend. A clinical psychology professor at the treatment center warns that this instance is very similar to cases where patients are addicted to video games or social media, wherein the virtual world takes precedence over the real one. No reports yet about exactly what he was bingeing on, but our money’s on “The Great British Baking Show.” And can you blame him? The things they make on that show! This is the first case of Netflix addiction but undoubtedly will not be the last. It’s just so easy to watch 19 episodes of “Law & Order” in a row! I’m not an addict, I’m just a dedicated fan. Please don’t take my computer away from me.

Losin’ the COPD blues

chameleonseye/iStock/Getty Images Plus

The pursuit of improved therapies for chronic obstructive pulmonary disease has produced a wealth of treatment options. But one new approach sounds better than them all. In a pilot study, an inexpensive, handheld device improved breathing control and self-confidence in people with COPD. And it boosted their quality of life. In fact, 3 months of use for only about a half hour a day most days of the week improved several pulmonary outcome measures, including maximal inspiratory pressure, maximal expiratory pressure, and distance on the 6-minute walk test. The 14 patients, all ex-smokers, even posted significant improvements in performance of “Happy Birthday,” “You Are My Sunshine,” and the respiratorily challenging Johnny Cash’s “Ring of Fire.” Technically called a “free reed wind instrument,” the pulmonary rehab device is also known as a “harmonica.” Can a mouth organ really counter emphysema? Well, neither of the two hard-blowing blues harmonica legends named Sonny Boy Williamson succumbed to COPD.

This is why you’re fat

Terry Rudd/MDedge News

Apparently, the real reason for rising levels of obesity is not sugar or lack of exercise – it’s memes. Researchers from England’s Loughborough University sent a memo to Parliament displaying evidence that Internet memes are contributing to unhealthy eating habits and sending damaging messages to today’s Internet-loving youth. Researchers blamed such memes as a picture of an obese child with the words “Free food? Count me in!” and a series of toned bodies next to a body made of hot dogs and pizza captioned “me.” Clearly, researchers have never experienced the pure joy of eating too much pizza and truly feeling like you are one with the pie. The report didn’t mention whether more-fit countries meme less or just work out more. We’re inclined to believe a healthy lifestyle includes eating in moderation, staying fit, and meme-ing to your heart’s content.

Mad for vittles

JuliaLototskaya/iStock/Getty Images Plus

You may not think you need to warn patients about eating rodent brains, but a Rochester, N.Y., man landed in a local hospital after his cognitive abilities took a plunge and his grip on everyday reality had loosened considerably. He’d also misplaced the ability to ambulate on his own. An MRI of his brain revealed a strange, tragic condition: The images bore a striking similarity to the brains of victims suffering from variant Creutzfeldt-Jakob disease, the prion-fueled fatal brain condition known more colloquially as “mad cow disease.” Yet most of the few hundred cases ever encountered were the result of eating bad beef in the United Kingdom more than a quarter century ago. How did this Empire State citizen succumb to a notorious English affliction? The culprits: squirrels. Seems the victim was an avid hunter who’d enjoyed his share of bushy-tailed acorn eaters, and who’d on occasion ensured that no part of his twitchy prey had gone to culinary waste. Including their brains.

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The hottest new drug? Netflix

selimaksan/E+

We all knew this was coming eventually. The first case of “Netflix addiction” has emerged, as a 26-year-old man in India has reportedly sought help at an addiction treatment center in Bangalore. Symptoms included 7-10 hours of TV watching per day and increasing isolation from others. Honestly, sounds like an ideal weekend. A clinical psychology professor at the treatment center warns that this instance is very similar to cases where patients are addicted to video games or social media, wherein the virtual world takes precedence over the real one. No reports yet about exactly what he was bingeing on, but our money’s on “The Great British Baking Show.” And can you blame him? The things they make on that show! This is the first case of Netflix addiction but undoubtedly will not be the last. It’s just so easy to watch 19 episodes of “Law & Order” in a row! I’m not an addict, I’m just a dedicated fan. Please don’t take my computer away from me.

Losin’ the COPD blues

chameleonseye/iStock/Getty Images Plus

The pursuit of improved therapies for chronic obstructive pulmonary disease has produced a wealth of treatment options. But one new approach sounds better than them all. In a pilot study, an inexpensive, handheld device improved breathing control and self-confidence in people with COPD. And it boosted their quality of life. In fact, 3 months of use for only about a half hour a day most days of the week improved several pulmonary outcome measures, including maximal inspiratory pressure, maximal expiratory pressure, and distance on the 6-minute walk test. The 14 patients, all ex-smokers, even posted significant improvements in performance of “Happy Birthday,” “You Are My Sunshine,” and the respiratorily challenging Johnny Cash’s “Ring of Fire.” Technically called a “free reed wind instrument,” the pulmonary rehab device is also known as a “harmonica.” Can a mouth organ really counter emphysema? Well, neither of the two hard-blowing blues harmonica legends named Sonny Boy Williamson succumbed to COPD.

This is why you’re fat

Terry Rudd/MDedge News

Apparently, the real reason for rising levels of obesity is not sugar or lack of exercise – it’s memes. Researchers from England’s Loughborough University sent a memo to Parliament displaying evidence that Internet memes are contributing to unhealthy eating habits and sending damaging messages to today’s Internet-loving youth. Researchers blamed such memes as a picture of an obese child with the words “Free food? Count me in!” and a series of toned bodies next to a body made of hot dogs and pizza captioned “me.” Clearly, researchers have never experienced the pure joy of eating too much pizza and truly feeling like you are one with the pie. The report didn’t mention whether more-fit countries meme less or just work out more. We’re inclined to believe a healthy lifestyle includes eating in moderation, staying fit, and meme-ing to your heart’s content.

Mad for vittles

JuliaLototskaya/iStock/Getty Images Plus

You may not think you need to warn patients about eating rodent brains, but a Rochester, N.Y., man landed in a local hospital after his cognitive abilities took a plunge and his grip on everyday reality had loosened considerably. He’d also misplaced the ability to ambulate on his own. An MRI of his brain revealed a strange, tragic condition: The images bore a striking similarity to the brains of victims suffering from variant Creutzfeldt-Jakob disease, the prion-fueled fatal brain condition known more colloquially as “mad cow disease.” Yet most of the few hundred cases ever encountered were the result of eating bad beef in the United Kingdom more than a quarter century ago. How did this Empire State citizen succumb to a notorious English affliction? The culprits: squirrels. Seems the victim was an avid hunter who’d enjoyed his share of bushy-tailed acorn eaters, and who’d on occasion ensured that no part of his twitchy prey had gone to culinary waste. Including their brains.

 

The hottest new drug? Netflix

selimaksan/E+

We all knew this was coming eventually. The first case of “Netflix addiction” has emerged, as a 26-year-old man in India has reportedly sought help at an addiction treatment center in Bangalore. Symptoms included 7-10 hours of TV watching per day and increasing isolation from others. Honestly, sounds like an ideal weekend. A clinical psychology professor at the treatment center warns that this instance is very similar to cases where patients are addicted to video games or social media, wherein the virtual world takes precedence over the real one. No reports yet about exactly what he was bingeing on, but our money’s on “The Great British Baking Show.” And can you blame him? The things they make on that show! This is the first case of Netflix addiction but undoubtedly will not be the last. It’s just so easy to watch 19 episodes of “Law & Order” in a row! I’m not an addict, I’m just a dedicated fan. Please don’t take my computer away from me.

Losin’ the COPD blues

chameleonseye/iStock/Getty Images Plus

The pursuit of improved therapies for chronic obstructive pulmonary disease has produced a wealth of treatment options. But one new approach sounds better than them all. In a pilot study, an inexpensive, handheld device improved breathing control and self-confidence in people with COPD. And it boosted their quality of life. In fact, 3 months of use for only about a half hour a day most days of the week improved several pulmonary outcome measures, including maximal inspiratory pressure, maximal expiratory pressure, and distance on the 6-minute walk test. The 14 patients, all ex-smokers, even posted significant improvements in performance of “Happy Birthday,” “You Are My Sunshine,” and the respiratorily challenging Johnny Cash’s “Ring of Fire.” Technically called a “free reed wind instrument,” the pulmonary rehab device is also known as a “harmonica.” Can a mouth organ really counter emphysema? Well, neither of the two hard-blowing blues harmonica legends named Sonny Boy Williamson succumbed to COPD.

This is why you’re fat

Terry Rudd/MDedge News

Apparently, the real reason for rising levels of obesity is not sugar or lack of exercise – it’s memes. Researchers from England’s Loughborough University sent a memo to Parliament displaying evidence that Internet memes are contributing to unhealthy eating habits and sending damaging messages to today’s Internet-loving youth. Researchers blamed such memes as a picture of an obese child with the words “Free food? Count me in!” and a series of toned bodies next to a body made of hot dogs and pizza captioned “me.” Clearly, researchers have never experienced the pure joy of eating too much pizza and truly feeling like you are one with the pie. The report didn’t mention whether more-fit countries meme less or just work out more. We’re inclined to believe a healthy lifestyle includes eating in moderation, staying fit, and meme-ing to your heart’s content.

Mad for vittles

JuliaLototskaya/iStock/Getty Images Plus

You may not think you need to warn patients about eating rodent brains, but a Rochester, N.Y., man landed in a local hospital after his cognitive abilities took a plunge and his grip on everyday reality had loosened considerably. He’d also misplaced the ability to ambulate on his own. An MRI of his brain revealed a strange, tragic condition: The images bore a striking similarity to the brains of victims suffering from variant Creutzfeldt-Jakob disease, the prion-fueled fatal brain condition known more colloquially as “mad cow disease.” Yet most of the few hundred cases ever encountered were the result of eating bad beef in the United Kingdom more than a quarter century ago. How did this Empire State citizen succumb to a notorious English affliction? The culprits: squirrels. Seems the victim was an avid hunter who’d enjoyed his share of bushy-tailed acorn eaters, and who’d on occasion ensured that no part of his twitchy prey had gone to culinary waste. Including their brains.

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Diagnosis of Epilepsy with Myoclonic-Atonic Seizures Often Changes

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Diagnosis of Epilepsy with Myoclonic-Atonic Seizures Often Changes
Epilepsy Res; 2018 Nov; Eschbach et al.

Pediatric patients who have been initially diagnosed with epilepsy with myoclonic-atonic seizures (EMAS) are likely to be switched to another diagnosis over time, according to a retrospective chart analysis of 77 children at Children’s Hospital of Colorado.

  • Over 50% of patients in this study were switched from suspected EMAS to another epilepsy diagnosis.
  • Among the 77 patients, 30 had an initial diagnosis of EMAS and 57 had a final diagnosis of EMAS.
  • Among 65% of patients who had more than one diagnosis over time, the first, second, and third diagnoses were provided within 1 year, 3 years, and 10 years after the onset of the disease.
  • Signs of Lennox-Gastaut syndrome (LGS), including paroxysmal fast activity, slow spike-and-wave, and tonic seizure, were detected in 50% of the 77 patients but only a minority received a final diagnosis of LGS.

Eschbach K., Moss A, Joshi C, et al. Diagnosis switching and outcomes in a cohort of patients with potential epilepsy with myoclonic-atonic seizures. Epilepsy Res. 2018; 147:95-101. https://doi.org/10.1016/j.eplepsyres.2018.09.011

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Epilepsy Res; 2018 Nov; Eschbach et al.
Epilepsy Res; 2018 Nov; Eschbach et al.

Pediatric patients who have been initially diagnosed with epilepsy with myoclonic-atonic seizures (EMAS) are likely to be switched to another diagnosis over time, according to a retrospective chart analysis of 77 children at Children’s Hospital of Colorado.

  • Over 50% of patients in this study were switched from suspected EMAS to another epilepsy diagnosis.
  • Among the 77 patients, 30 had an initial diagnosis of EMAS and 57 had a final diagnosis of EMAS.
  • Among 65% of patients who had more than one diagnosis over time, the first, second, and third diagnoses were provided within 1 year, 3 years, and 10 years after the onset of the disease.
  • Signs of Lennox-Gastaut syndrome (LGS), including paroxysmal fast activity, slow spike-and-wave, and tonic seizure, were detected in 50% of the 77 patients but only a minority received a final diagnosis of LGS.

Eschbach K., Moss A, Joshi C, et al. Diagnosis switching and outcomes in a cohort of patients with potential epilepsy with myoclonic-atonic seizures. Epilepsy Res. 2018; 147:95-101. https://doi.org/10.1016/j.eplepsyres.2018.09.011

Pediatric patients who have been initially diagnosed with epilepsy with myoclonic-atonic seizures (EMAS) are likely to be switched to another diagnosis over time, according to a retrospective chart analysis of 77 children at Children’s Hospital of Colorado.

  • Over 50% of patients in this study were switched from suspected EMAS to another epilepsy diagnosis.
  • Among the 77 patients, 30 had an initial diagnosis of EMAS and 57 had a final diagnosis of EMAS.
  • Among 65% of patients who had more than one diagnosis over time, the first, second, and third diagnoses were provided within 1 year, 3 years, and 10 years after the onset of the disease.
  • Signs of Lennox-Gastaut syndrome (LGS), including paroxysmal fast activity, slow spike-and-wave, and tonic seizure, were detected in 50% of the 77 patients but only a minority received a final diagnosis of LGS.

Eschbach K., Moss A, Joshi C, et al. Diagnosis switching and outcomes in a cohort of patients with potential epilepsy with myoclonic-atonic seizures. Epilepsy Res. 2018; 147:95-101. https://doi.org/10.1016/j.eplepsyres.2018.09.011

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Diagnosis of Epilepsy with Myoclonic-Atonic Seizures Often Changes
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Finding Better Way to Pinpoint Seizure Onset Zone

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Finding Better Way to Pinpoint Seizure Onset Zone
Epilepsy Res; 2018 Oct; Kuo et al.

Researchers have found that using 256-channel high-density EEG and high-resolution head models of individual patients can help establish precise electrical source imaging of oscillatory features of the onset of a seizure, which in turn improves presurgical planning. Precisely localizing the seizure onset zone in the cortex is important for the best surgical outcomes.

  • Using noninvasive electrical source imaging to plan surgery has proven problematic to date because of the interference of noise artifacts and non-seizure activity, which can be superimposed over the seizure signal.
  • In this study, high density EEG was combined with exact sensor positioning and individual electrical head models, which were derived from T1 MRI results.
  • Among 84 seizures, investigators were able to localize the onset of 56.
  • High density EEG with interictal spikes was more accurate than international 10-20 EEG for interictal spikes and ictal onset.

Kuo C-C, Tucker DM, Luu P, et al. EEG source imaging of epileptic activity at seizure onset. Epilepsy Res. 2018;146:160-171. https://doi.org/10.1016/j.eplepsyres.2018.07.006

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Epilepsy Res; 2018 Oct; Kuo et al.
Epilepsy Res; 2018 Oct; Kuo et al.

Researchers have found that using 256-channel high-density EEG and high-resolution head models of individual patients can help establish precise electrical source imaging of oscillatory features of the onset of a seizure, which in turn improves presurgical planning. Precisely localizing the seizure onset zone in the cortex is important for the best surgical outcomes.

  • Using noninvasive electrical source imaging to plan surgery has proven problematic to date because of the interference of noise artifacts and non-seizure activity, which can be superimposed over the seizure signal.
  • In this study, high density EEG was combined with exact sensor positioning and individual electrical head models, which were derived from T1 MRI results.
  • Among 84 seizures, investigators were able to localize the onset of 56.
  • High density EEG with interictal spikes was more accurate than international 10-20 EEG for interictal spikes and ictal onset.

Kuo C-C, Tucker DM, Luu P, et al. EEG source imaging of epileptic activity at seizure onset. Epilepsy Res. 2018;146:160-171. https://doi.org/10.1016/j.eplepsyres.2018.07.006

Researchers have found that using 256-channel high-density EEG and high-resolution head models of individual patients can help establish precise electrical source imaging of oscillatory features of the onset of a seizure, which in turn improves presurgical planning. Precisely localizing the seizure onset zone in the cortex is important for the best surgical outcomes.

  • Using noninvasive electrical source imaging to plan surgery has proven problematic to date because of the interference of noise artifacts and non-seizure activity, which can be superimposed over the seizure signal.
  • In this study, high density EEG was combined with exact sensor positioning and individual electrical head models, which were derived from T1 MRI results.
  • Among 84 seizures, investigators were able to localize the onset of 56.
  • High density EEG with interictal spikes was more accurate than international 10-20 EEG for interictal spikes and ictal onset.

Kuo C-C, Tucker DM, Luu P, et al. EEG source imaging of epileptic activity at seizure onset. Epilepsy Res. 2018;146:160-171. https://doi.org/10.1016/j.eplepsyres.2018.07.006

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Unique MRI Findings in Juvenile Myoclonic Epilepsy

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Unique MRI Findings in Juvenile Myoclonic Epilepsy
Epilepsia; ePub 2018 Oct 3; Garcia-Ramos et al.

The cortical regions of the brains of patients with juvenile myoclonic epilepsy (JME) are more likely to be disassociated from subcortical structures, according to a recent study that compared the MRI readings of JME patients to those of normal children. 

  • Investigators from the University of Wisconsin School of Medicine compared 21 children with JME to 22 healthy controls over a 2 year period.
  • Normal children had modular cortical development and network integration between cortical and subcortical regions.
  • Patients with epilepsy had a less modular cortical network that was disassociated from subcortical structures.
  • Children with JME were also found to have weaker modules or communities, as indicated by higher clustering and lower modularity indices.

 

Garcia-Ramos C, Dabbs K, Lin JJ, et al. Progressive dissociation of cortical and subcortical network development in children with newonset juvenile myoclonic epilepsy [Published online ahead of print Oct 3, 2018]. Epilepsia.  https://doi.org/10.1111/epi.14560

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Epilepsia; ePub 2018 Oct 3; Garcia-Ramos et al.
Epilepsia; ePub 2018 Oct 3; Garcia-Ramos et al.

The cortical regions of the brains of patients with juvenile myoclonic epilepsy (JME) are more likely to be disassociated from subcortical structures, according to a recent study that compared the MRI readings of JME patients to those of normal children. 

  • Investigators from the University of Wisconsin School of Medicine compared 21 children with JME to 22 healthy controls over a 2 year period.
  • Normal children had modular cortical development and network integration between cortical and subcortical regions.
  • Patients with epilepsy had a less modular cortical network that was disassociated from subcortical structures.
  • Children with JME were also found to have weaker modules or communities, as indicated by higher clustering and lower modularity indices.

 

Garcia-Ramos C, Dabbs K, Lin JJ, et al. Progressive dissociation of cortical and subcortical network development in children with newonset juvenile myoclonic epilepsy [Published online ahead of print Oct 3, 2018]. Epilepsia.  https://doi.org/10.1111/epi.14560

The cortical regions of the brains of patients with juvenile myoclonic epilepsy (JME) are more likely to be disassociated from subcortical structures, according to a recent study that compared the MRI readings of JME patients to those of normal children. 

  • Investigators from the University of Wisconsin School of Medicine compared 21 children with JME to 22 healthy controls over a 2 year period.
  • Normal children had modular cortical development and network integration between cortical and subcortical regions.
  • Patients with epilepsy had a less modular cortical network that was disassociated from subcortical structures.
  • Children with JME were also found to have weaker modules or communities, as indicated by higher clustering and lower modularity indices.

 

Garcia-Ramos C, Dabbs K, Lin JJ, et al. Progressive dissociation of cortical and subcortical network development in children with newonset juvenile myoclonic epilepsy [Published online ahead of print Oct 3, 2018]. Epilepsia.  https://doi.org/10.1111/epi.14560

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Platelet-rich patch helps heal difficult diabetic foot ulcers

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Diabetic foot ulcers that were designated as difficult to treat were 58% more likely to heal when they were treated with LeucoPatch than using the best standard care alone in a randomized, controlled study.

With the LeucoPatch – which contained study participants’ own cells (platelets, fibrin, and leukocytes) – 34.1% of ulcers healed within 20 weeks versus 21.6% of ulcers that were treated using the best standard care (unadjusted odds ratio, 1.58; 95% confidence interval, 1.06-2.25; P = .02). Healing was defined as complete epithelialization maintained for 4 weeks, as confirmed by an observer blinded to the treatment group.

Dr. Frances Game


Results remained significant after adjusting for baseline wound size (adjusted OR 1.89; P = .02) and following a per-protocol analysis (aOR, 1.75; P = .048).

Furthermore, time to healing was shorter in the intervention group (P = .02), lead study investigator Frances Game, MD, of the Derby (England) Teaching Hospitals National Health Service Foundation Trust, reported at the annual meeting of the European Association for the Study of Diabetes.

“Successive systematic reviews from the International Working Group of the Diabetic Foot have shown that there’s very poor evidence for many of the things that we do in day-to-day practice,” she said.

“Having said that, there have been some positive studies using platelets or platelet-rich plasma to improve healing of the diabetic foot,” Dr. Game noted, although results have been inconsistent. From this the idea of the LeucoPatch was born. This is an autologous active cell therapy, which according to the Danish company Reapplix that markets it, helps patients “heal themselves.”

The LeucoPatch system is made by taking 18 mL of a patient’s blood and spinning the collection tube in a centrifuge for 20 minutes to generate a three-layered disc that contains fibrin, platelets, and leukocytes. This can then be applied to the surface of the diabetic foot ulcer. Dr. Game noted that 18 mL of blood will make a 5-cm patch and more than one patch can be made from the blood sample.

“It looks like a bit of wet skin when it comes out of the centrifuge and you just put it on sole side down. It’s taking the patient’s own cells, that often aren’t getting to the ulcer because of the morbidity of the patient and vascular disease, and actually putting them where they need to be,” she explained. The patch usually becomes absorbed within a week; depending on the ulcer, reapplication may be required.

“It’s quite a straightforward procedure that’s performed the bedside,” Dr. Game observed. “That’s how we were able to recruit so many patients, as it’s quite simple.” Indeed, almost 600 people with diabetic foot ulcers agreed to participate in the study, but only those with difficult-to-treat ulcers were included after a 4-week run-in period. The 269 patients who were finally randomized were treated at 32 specialist diabetic foot clinics in the United Kingdom, Denmark, and Sweden.

The majority of participants were male (82%) and had type 2 diabetes mellitus (83%). The mean age was 62 years and the median duration of diabetes was 16 years. The mean ulcer area was 240 mm2, with 87% being superficial, 10% reaching down to the tendon, and 3% down to the bone. In 78% of cases, the total forefoot was affected, with the plantar forefoot and hind foot affected in a respective 42% and 22% of cases.

The LeucoPatch system is already being used in several European countries, including Germany and Belgium, Dr. Game noted. However, this is the first randomized, controlled trial to demonstrate a clinical and statistically significant benefit. The data show that the weekly application of LeucoPatch is clearly of benefit in a population of patients with hard-to-heal diabetic foot ulcers.

“The low drop-out numbers suggest a good patient acceptability,” she noted, and “the treatment was without apparent increase in adverse events, particularly without evidence of new onset anemia.”

Cost-effectiveness data were collected throughout the study and will be available at a future date when these have been analyzed, Dr. Game said.

The LeucoPatch system received Food and Drug Administration approval in April 2017.

The research was published online in the Lancet Diabetes & Endocrinology ahead of the presentation.

The trial was funded by Reapplix. Dr. Game reported receiving research funding from the company.

SOURCES: Game F et al. EASD 2018, Abstract 9.

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Diabetic foot ulcers that were designated as difficult to treat were 58% more likely to heal when they were treated with LeucoPatch than using the best standard care alone in a randomized, controlled study.

With the LeucoPatch – which contained study participants’ own cells (platelets, fibrin, and leukocytes) – 34.1% of ulcers healed within 20 weeks versus 21.6% of ulcers that were treated using the best standard care (unadjusted odds ratio, 1.58; 95% confidence interval, 1.06-2.25; P = .02). Healing was defined as complete epithelialization maintained for 4 weeks, as confirmed by an observer blinded to the treatment group.

Dr. Frances Game


Results remained significant after adjusting for baseline wound size (adjusted OR 1.89; P = .02) and following a per-protocol analysis (aOR, 1.75; P = .048).

Furthermore, time to healing was shorter in the intervention group (P = .02), lead study investigator Frances Game, MD, of the Derby (England) Teaching Hospitals National Health Service Foundation Trust, reported at the annual meeting of the European Association for the Study of Diabetes.

“Successive systematic reviews from the International Working Group of the Diabetic Foot have shown that there’s very poor evidence for many of the things that we do in day-to-day practice,” she said.

“Having said that, there have been some positive studies using platelets or platelet-rich plasma to improve healing of the diabetic foot,” Dr. Game noted, although results have been inconsistent. From this the idea of the LeucoPatch was born. This is an autologous active cell therapy, which according to the Danish company Reapplix that markets it, helps patients “heal themselves.”

The LeucoPatch system is made by taking 18 mL of a patient’s blood and spinning the collection tube in a centrifuge for 20 minutes to generate a three-layered disc that contains fibrin, platelets, and leukocytes. This can then be applied to the surface of the diabetic foot ulcer. Dr. Game noted that 18 mL of blood will make a 5-cm patch and more than one patch can be made from the blood sample.

“It looks like a bit of wet skin when it comes out of the centrifuge and you just put it on sole side down. It’s taking the patient’s own cells, that often aren’t getting to the ulcer because of the morbidity of the patient and vascular disease, and actually putting them where they need to be,” she explained. The patch usually becomes absorbed within a week; depending on the ulcer, reapplication may be required.

“It’s quite a straightforward procedure that’s performed the bedside,” Dr. Game observed. “That’s how we were able to recruit so many patients, as it’s quite simple.” Indeed, almost 600 people with diabetic foot ulcers agreed to participate in the study, but only those with difficult-to-treat ulcers were included after a 4-week run-in period. The 269 patients who were finally randomized were treated at 32 specialist diabetic foot clinics in the United Kingdom, Denmark, and Sweden.

The majority of participants were male (82%) and had type 2 diabetes mellitus (83%). The mean age was 62 years and the median duration of diabetes was 16 years. The mean ulcer area was 240 mm2, with 87% being superficial, 10% reaching down to the tendon, and 3% down to the bone. In 78% of cases, the total forefoot was affected, with the plantar forefoot and hind foot affected in a respective 42% and 22% of cases.

The LeucoPatch system is already being used in several European countries, including Germany and Belgium, Dr. Game noted. However, this is the first randomized, controlled trial to demonstrate a clinical and statistically significant benefit. The data show that the weekly application of LeucoPatch is clearly of benefit in a population of patients with hard-to-heal diabetic foot ulcers.

“The low drop-out numbers suggest a good patient acceptability,” she noted, and “the treatment was without apparent increase in adverse events, particularly without evidence of new onset anemia.”

Cost-effectiveness data were collected throughout the study and will be available at a future date when these have been analyzed, Dr. Game said.

The LeucoPatch system received Food and Drug Administration approval in April 2017.

The research was published online in the Lancet Diabetes & Endocrinology ahead of the presentation.

The trial was funded by Reapplix. Dr. Game reported receiving research funding from the company.

SOURCES: Game F et al. EASD 2018, Abstract 9.

 

Diabetic foot ulcers that were designated as difficult to treat were 58% more likely to heal when they were treated with LeucoPatch than using the best standard care alone in a randomized, controlled study.

With the LeucoPatch – which contained study participants’ own cells (platelets, fibrin, and leukocytes) – 34.1% of ulcers healed within 20 weeks versus 21.6% of ulcers that were treated using the best standard care (unadjusted odds ratio, 1.58; 95% confidence interval, 1.06-2.25; P = .02). Healing was defined as complete epithelialization maintained for 4 weeks, as confirmed by an observer blinded to the treatment group.

Dr. Frances Game


Results remained significant after adjusting for baseline wound size (adjusted OR 1.89; P = .02) and following a per-protocol analysis (aOR, 1.75; P = .048).

Furthermore, time to healing was shorter in the intervention group (P = .02), lead study investigator Frances Game, MD, of the Derby (England) Teaching Hospitals National Health Service Foundation Trust, reported at the annual meeting of the European Association for the Study of Diabetes.

“Successive systematic reviews from the International Working Group of the Diabetic Foot have shown that there’s very poor evidence for many of the things that we do in day-to-day practice,” she said.

“Having said that, there have been some positive studies using platelets or platelet-rich plasma to improve healing of the diabetic foot,” Dr. Game noted, although results have been inconsistent. From this the idea of the LeucoPatch was born. This is an autologous active cell therapy, which according to the Danish company Reapplix that markets it, helps patients “heal themselves.”

The LeucoPatch system is made by taking 18 mL of a patient’s blood and spinning the collection tube in a centrifuge for 20 minutes to generate a three-layered disc that contains fibrin, platelets, and leukocytes. This can then be applied to the surface of the diabetic foot ulcer. Dr. Game noted that 18 mL of blood will make a 5-cm patch and more than one patch can be made from the blood sample.

“It looks like a bit of wet skin when it comes out of the centrifuge and you just put it on sole side down. It’s taking the patient’s own cells, that often aren’t getting to the ulcer because of the morbidity of the patient and vascular disease, and actually putting them where they need to be,” she explained. The patch usually becomes absorbed within a week; depending on the ulcer, reapplication may be required.

“It’s quite a straightforward procedure that’s performed the bedside,” Dr. Game observed. “That’s how we were able to recruit so many patients, as it’s quite simple.” Indeed, almost 600 people with diabetic foot ulcers agreed to participate in the study, but only those with difficult-to-treat ulcers were included after a 4-week run-in period. The 269 patients who were finally randomized were treated at 32 specialist diabetic foot clinics in the United Kingdom, Denmark, and Sweden.

The majority of participants were male (82%) and had type 2 diabetes mellitus (83%). The mean age was 62 years and the median duration of diabetes was 16 years. The mean ulcer area was 240 mm2, with 87% being superficial, 10% reaching down to the tendon, and 3% down to the bone. In 78% of cases, the total forefoot was affected, with the plantar forefoot and hind foot affected in a respective 42% and 22% of cases.

The LeucoPatch system is already being used in several European countries, including Germany and Belgium, Dr. Game noted. However, this is the first randomized, controlled trial to demonstrate a clinical and statistically significant benefit. The data show that the weekly application of LeucoPatch is clearly of benefit in a population of patients with hard-to-heal diabetic foot ulcers.

“The low drop-out numbers suggest a good patient acceptability,” she noted, and “the treatment was without apparent increase in adverse events, particularly without evidence of new onset anemia.”

Cost-effectiveness data were collected throughout the study and will be available at a future date when these have been analyzed, Dr. Game said.

The LeucoPatch system received Food and Drug Administration approval in April 2017.

The research was published online in the Lancet Diabetes & Endocrinology ahead of the presentation.

The trial was funded by Reapplix. Dr. Game reported receiving research funding from the company.

SOURCES: Game F et al. EASD 2018, Abstract 9.

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REPORTING FROM EASD 2018

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Key clinical point: Weekly application of LeucoPatch enabled greater healing in a shorter time frame than standard care.

Major finding: Within 20 weeks, 34.1% versus 21.6% of diabetic foot ulcers had healed (unadjusted odds ratio, 1.58; 95% confidence interval, 1.06-2.25; P = .02).

Study details: A multicenter, multinational, observer-blinded, randomized, controlled trial of 269 patients with hard-to-heal diabetic foot ulcers.

Disclosures: The trial was funded by Reapplix. Dr. Game reported receiving research funding from the company.

Sources: Game F et al. EASD 2018, Abstract 9.

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