Neurology

The Food and Drug Administration has cleared Xyrem (sodium oxybate) oral solution to treat cataplexy and excessive daytime sleepiness in patients ages 7-17 with narcolepsy.

The central nervous system depressant previously had been approved to treat cataplexy in adults with narcolepsy.

The current approval was granted by the FDA under a Priority Review designation. Xyrem also received the FDA’s Orphan Drug designation, which is intended to encourage the development of drugs for rare diseases.

The agency noted in a press release, however, that the drug would continue to be available only through risk evaluation mitigation strategy (REMS) programs because of “the risk of serious outcomes resulting from inappropriate prescribing, misuse, abuse and diversion.” Xyrem either alone or in combination with other CNS depressants may be associated with reactions including seizure, respiratory depression, decreases in the level of consciousness, coma, and death, the FDA said.

The most common adverse reactions in pediatric patients were enuresis, nausea, headache, vomiting, weight decrease, decreased appetite, and dizziness.

For more information on prescribing Xyrem for pediatric patients, see the revised labeling information on the FDA website.

rpizzi@mdedge.com

The Food and Drug Administration has cleared Xyrem (sodium oxybate) oral solution to treat cataplexy and excessive daytime sleepiness in patients ages 7-17 with narcolepsy.

The central nervous system depressant previously had been approved to treat cataplexy in adults with narcolepsy.

The current approval was granted by the FDA under a Priority Review designation. Xyrem also received the FDA’s Orphan Drug designation, which is intended to encourage the development of drugs for rare diseases.

The agency noted in a press release, however, that the drug would continue to be available only through risk evaluation mitigation strategy (REMS) programs because of “the risk of serious outcomes resulting from inappropriate prescribing, misuse, abuse and diversion.” Xyrem either alone or in combination with other CNS depressants may be associated with reactions including seizure, respiratory depression, decreases in the level of consciousness, coma, and death, the FDA said.

The most common adverse reactions in pediatric patients were enuresis, nausea, headache, vomiting, weight decrease, decreased appetite, and dizziness.

For more information on prescribing Xyrem for pediatric patients, see the revised labeling information on the FDA website.

rpizzi@mdedge.com

The Food and Drug Administration has cleared Xyrem (sodium oxybate) oral solution to treat cataplexy and excessive daytime sleepiness in patients ages 7-17 with narcolepsy.

The central nervous system depressant previously had been approved to treat cataplexy in adults with narcolepsy.

The current approval was granted by the FDA under a Priority Review designation. Xyrem also received the FDA’s Orphan Drug designation, which is intended to encourage the development of drugs for rare diseases.

The agency noted in a press release, however, that the drug would continue to be available only through risk evaluation mitigation strategy (REMS) programs because of “the risk of serious outcomes resulting from inappropriate prescribing, misuse, abuse and diversion.” Xyrem either alone or in combination with other CNS depressants may be associated with reactions including seizure, respiratory depression, decreases in the level of consciousness, coma, and death, the FDA said.

The most common adverse reactions in pediatric patients were enuresis, nausea, headache, vomiting, weight decrease, decreased appetite, and dizziness.

For more information on prescribing Xyrem for pediatric patients, see the revised labeling information on the FDA website.

rpizzi@mdedge.com

BOSTON – A multimodal pain regimen allowed for safe and effective same-day discharge of women undergoing mastectomy procedures, a recent study showed.

Women had little need for stronger oral narcotic use in the single center, retrospective study presented at the annual clinical congress of the American College of Surgeons.

The analysis included 72 consecutive mastectomies performed at a single center from November 2015 to July 2017. Most mastectomies were bilateral (61, or 84.7%) while 11 (15.3%) were unilateral.

Patients received a standardized pain regimen including 1 gram of IV acetaminophen interoperatively, combined with 30 mg of IV ketorolac and a 4-level intercostal nerve block with liposomal bupivacaine.

Liposomal bupivacaine has a longer half-life than other anesthetics, according to lead study author Radbeh Torabi, MD, a fifth-year plastic surgery resident at Louisiana State University (LSU) Health Science Center in New Orleans.

“That allows for prolonged pain control, especially during the time when the patient’s going to have the most amount of pain, which is the first day to two days postoperatively,” Dr. Torabi said in an interview.

All 72 patients were discharged home on the same day with just a 1-week prescription for acetaminophen with codeine.

Only 5 patients presented to the emergency room in the 30-day postoperative period, and of those, only 2 (2.8%) required readmission for reasons other than mastectomy-related pain, investigators said. The remaining 3 patients did present with pain, but did not require hospital admission.

Taken together, these findings suggest that this multimodal strategy offers excellent pain control and has the potential to minimize inpatient admissions while decreasing oral narcotic use, investigators said in an interview following their presentation.

“The main takeaway is reducing the amount of prescriptions we give,” Dr. Torabi said.

Study co-author Cameron T. Ward Coker, MD, a fourth-year general surgery resident at LSU, said the multimodal pain strategy used in this study could represent a step toward eliminating the risks associated with opioid prescribing.

“From the feedback we got from our lecture and the other surgeons in the room, it seems like that’s already becoming a widespread phenomenon,” Dr. Coker said.

Patients in the study had an average age of about 57 years and an average BMI of 30, according to the investigators.

Dr. Coker and Dr. Torabi had no disclosures related to the presentation.

SOURCE: Torabi R, et al. Scientific forum abstract at American College of Surgeons Clinical Congress. 2018 Oct 23.

BOSTON – A multimodal pain regimen allowed for safe and effective same-day discharge of women undergoing mastectomy procedures, a recent study showed.

Women had little need for stronger oral narcotic use in the single center, retrospective study presented at the annual clinical congress of the American College of Surgeons.

The analysis included 72 consecutive mastectomies performed at a single center from November 2015 to July 2017. Most mastectomies were bilateral (61, or 84.7%) while 11 (15.3%) were unilateral.

Patients received a standardized pain regimen including 1 gram of IV acetaminophen interoperatively, combined with 30 mg of IV ketorolac and a 4-level intercostal nerve block with liposomal bupivacaine.

Liposomal bupivacaine has a longer half-life than other anesthetics, according to lead study author Radbeh Torabi, MD, a fifth-year plastic surgery resident at Louisiana State University (LSU) Health Science Center in New Orleans.

“That allows for prolonged pain control, especially during the time when the patient’s going to have the most amount of pain, which is the first day to two days postoperatively,” Dr. Torabi said in an interview.

All 72 patients were discharged home on the same day with just a 1-week prescription for acetaminophen with codeine.

Only 5 patients presented to the emergency room in the 30-day postoperative period, and of those, only 2 (2.8%) required readmission for reasons other than mastectomy-related pain, investigators said. The remaining 3 patients did present with pain, but did not require hospital admission.

Taken together, these findings suggest that this multimodal strategy offers excellent pain control and has the potential to minimize inpatient admissions while decreasing oral narcotic use, investigators said in an interview following their presentation.

“The main takeaway is reducing the amount of prescriptions we give,” Dr. Torabi said.

Study co-author Cameron T. Ward Coker, MD, a fourth-year general surgery resident at LSU, said the multimodal pain strategy used in this study could represent a step toward eliminating the risks associated with opioid prescribing.

“From the feedback we got from our lecture and the other surgeons in the room, it seems like that’s already becoming a widespread phenomenon,” Dr. Coker said.

Patients in the study had an average age of about 57 years and an average BMI of 30, according to the investigators.

Dr. Coker and Dr. Torabi had no disclosures related to the presentation.

SOURCE: Torabi R, et al. Scientific forum abstract at American College of Surgeons Clinical Congress. 2018 Oct 23.

BOSTON – A multimodal pain regimen allowed for safe and effective same-day discharge of women undergoing mastectomy procedures, a recent study showed.

Women had little need for stronger oral narcotic use in the single center, retrospective study presented at the annual clinical congress of the American College of Surgeons.

The analysis included 72 consecutive mastectomies performed at a single center from November 2015 to July 2017. Most mastectomies were bilateral (61, or 84.7%) while 11 (15.3%) were unilateral.

Patients received a standardized pain regimen including 1 gram of IV acetaminophen interoperatively, combined with 30 mg of IV ketorolac and a 4-level intercostal nerve block with liposomal bupivacaine.

Liposomal bupivacaine has a longer half-life than other anesthetics, according to lead study author Radbeh Torabi, MD, a fifth-year plastic surgery resident at Louisiana State University (LSU) Health Science Center in New Orleans.

“That allows for prolonged pain control, especially during the time when the patient’s going to have the most amount of pain, which is the first day to two days postoperatively,” Dr. Torabi said in an interview.

All 72 patients were discharged home on the same day with just a 1-week prescription for acetaminophen with codeine.

Only 5 patients presented to the emergency room in the 30-day postoperative period, and of those, only 2 (2.8%) required readmission for reasons other than mastectomy-related pain, investigators said. The remaining 3 patients did present with pain, but did not require hospital admission.

Taken together, these findings suggest that this multimodal strategy offers excellent pain control and has the potential to minimize inpatient admissions while decreasing oral narcotic use, investigators said in an interview following their presentation.

“The main takeaway is reducing the amount of prescriptions we give,” Dr. Torabi said.

Study co-author Cameron T. Ward Coker, MD, a fourth-year general surgery resident at LSU, said the multimodal pain strategy used in this study could represent a step toward eliminating the risks associated with opioid prescribing.

“From the feedback we got from our lecture and the other surgeons in the room, it seems like that’s already becoming a widespread phenomenon,” Dr. Coker said.

Patients in the study had an average age of about 57 years and an average BMI of 30, according to the investigators.

Dr. Coker and Dr. Torabi had no disclosures related to the presentation.

SOURCE: Torabi R, et al. Scientific forum abstract at American College of Surgeons Clinical Congress. 2018 Oct 23.

SAN DIEGO – Hospitalized patients who developed acute kidney injury and fully recovered faced triple the risk of dementia of other hospitalized patients.

That’s according to a new study offering more evidence of a link between kidney disease and neurological problems.

“Clinicians should know that AKI is associated with poor long-term outcomes,” said lead author Jessica B. Kendrick MD, associate professor of medicine at the University of Colorado, Aurora. “We need to identify ways to prevent these long-term consequences.”

The findings were presented at Kidney Week 2018, sponsored by the American Society of Nephrology.

According to Dr. Kendrick, the acute neurological effects of AKI are well known. But no previous studies have examined the potential long-term cerebrovascular complications of AKI.

For the new study, Dr. Kendrick and her colleagues retrospectively analyzed 2,082 hospitalized patients in Utah from 1999 to 2009: 1,041 who completely recovered from AKI by discharge, and 1,041 who did not have AKI.

The average age was 61 years, and the average baseline creatinine was 0.9 ± 0.2 mg/dL. Over a median follow-up of 6 years, 97 patients developed dementia.

Those with AKI were more likely to develop dementia compared with the control group: 7% vs. 2% (hazard ratio, 3.4; 95% confidence interval, 2.14-5.40).

Other studies have linked kidney disease to cognitive impairment.

“There are a lot of theories as to why this is,” nephrologist Daniel Weiner, MD, of Tufts University, Boston, said in an interview. “It is most likely that the presence of kidney disease identifies individuals with a high burden of vascular disease, and that vascular disease, particularly of the small blood vessels, is an important contributor to cognitive impairment and dementia.”

That appears to be most notable in people who have protein in their urine, Dr. Weiner added. “The presence of protein in the urine identifies a severe enough process to affect the blood vessels in the kidney, and there is no reason to think that blood vessels elsewhere in the body, including in the brain, are not similarly affected.”

As for the current study, Dr. Weiner said it could support the vascular disease theory.

“People with vulnerable kidneys to acute injury also have vulnerable brains to acute injury,” he said. “People who get AKI usually have susceptibility to perfusion-related kidney injury. In other words, the small blood vessels that supply the kidney are unable to compensate to maintain sufficient blood flow during a time of low blood pressure or other systemic illness.”

That vulnerability “suggests to me that small blood vessels elsewhere in the body are less likely to be able to respond to challenges like low blood pressure,” Dr. Weiner explained. “If this occurs in the brain, it leads to microvascular disease and greater abnormal white-matter burden. This change in the brain anatomy is highly correlated with cognitive impairment.”

How can physicians put these finding to use? “These patients may require more monitoring,” Dr. Kendrick said. “For example, patients with AKI and complete recovery may not have any follow-up with a nephrologist, and perhaps they should.”

Moving forward, she said, “we are examining the association of AKI with cognitive dysfunction in different patient populations.” Researchers also are planning studies to better understand the mechanisms that are at work, she said.

The National Heart, Lung, and Blood Institute funded the study. The study authors had no disclosures.
 

SOURCE: Kendrick JB et al. Kidney Week 2018. Abstract TH-OR116.

SAN DIEGO – Hospitalized patients who developed acute kidney injury and fully recovered faced triple the risk of dementia of other hospitalized patients.

That’s according to a new study offering more evidence of a link between kidney disease and neurological problems.

“Clinicians should know that AKI is associated with poor long-term outcomes,” said lead author Jessica B. Kendrick MD, associate professor of medicine at the University of Colorado, Aurora. “We need to identify ways to prevent these long-term consequences.”

The findings were presented at Kidney Week 2018, sponsored by the American Society of Nephrology.

According to Dr. Kendrick, the acute neurological effects of AKI are well known. But no previous studies have examined the potential long-term cerebrovascular complications of AKI.

For the new study, Dr. Kendrick and her colleagues retrospectively analyzed 2,082 hospitalized patients in Utah from 1999 to 2009: 1,041 who completely recovered from AKI by discharge, and 1,041 who did not have AKI.

The average age was 61 years, and the average baseline creatinine was 0.9 ± 0.2 mg/dL. Over a median follow-up of 6 years, 97 patients developed dementia.

Those with AKI were more likely to develop dementia compared with the control group: 7% vs. 2% (hazard ratio, 3.4; 95% confidence interval, 2.14-5.40).

Other studies have linked kidney disease to cognitive impairment.

“There are a lot of theories as to why this is,” nephrologist Daniel Weiner, MD, of Tufts University, Boston, said in an interview. “It is most likely that the presence of kidney disease identifies individuals with a high burden of vascular disease, and that vascular disease, particularly of the small blood vessels, is an important contributor to cognitive impairment and dementia.”

That appears to be most notable in people who have protein in their urine, Dr. Weiner added. “The presence of protein in the urine identifies a severe enough process to affect the blood vessels in the kidney, and there is no reason to think that blood vessels elsewhere in the body, including in the brain, are not similarly affected.”

As for the current study, Dr. Weiner said it could support the vascular disease theory.

“People with vulnerable kidneys to acute injury also have vulnerable brains to acute injury,” he said. “People who get AKI usually have susceptibility to perfusion-related kidney injury. In other words, the small blood vessels that supply the kidney are unable to compensate to maintain sufficient blood flow during a time of low blood pressure or other systemic illness.”

That vulnerability “suggests to me that small blood vessels elsewhere in the body are less likely to be able to respond to challenges like low blood pressure,” Dr. Weiner explained. “If this occurs in the brain, it leads to microvascular disease and greater abnormal white-matter burden. This change in the brain anatomy is highly correlated with cognitive impairment.”

How can physicians put these finding to use? “These patients may require more monitoring,” Dr. Kendrick said. “For example, patients with AKI and complete recovery may not have any follow-up with a nephrologist, and perhaps they should.”

Moving forward, she said, “we are examining the association of AKI with cognitive dysfunction in different patient populations.” Researchers also are planning studies to better understand the mechanisms that are at work, she said.

The National Heart, Lung, and Blood Institute funded the study. The study authors had no disclosures.
 

SOURCE: Kendrick JB et al. Kidney Week 2018. Abstract TH-OR116.

SAN DIEGO – Hospitalized patients who developed acute kidney injury and fully recovered faced triple the risk of dementia of other hospitalized patients.

That’s according to a new study offering more evidence of a link between kidney disease and neurological problems.

“Clinicians should know that AKI is associated with poor long-term outcomes,” said lead author Jessica B. Kendrick MD, associate professor of medicine at the University of Colorado, Aurora. “We need to identify ways to prevent these long-term consequences.”

The findings were presented at Kidney Week 2018, sponsored by the American Society of Nephrology.

According to Dr. Kendrick, the acute neurological effects of AKI are well known. But no previous studies have examined the potential long-term cerebrovascular complications of AKI.

For the new study, Dr. Kendrick and her colleagues retrospectively analyzed 2,082 hospitalized patients in Utah from 1999 to 2009: 1,041 who completely recovered from AKI by discharge, and 1,041 who did not have AKI.

The average age was 61 years, and the average baseline creatinine was 0.9 ± 0.2 mg/dL. Over a median follow-up of 6 years, 97 patients developed dementia.

Those with AKI were more likely to develop dementia compared with the control group: 7% vs. 2% (hazard ratio, 3.4; 95% confidence interval, 2.14-5.40).

Other studies have linked kidney disease to cognitive impairment.

“There are a lot of theories as to why this is,” nephrologist Daniel Weiner, MD, of Tufts University, Boston, said in an interview. “It is most likely that the presence of kidney disease identifies individuals with a high burden of vascular disease, and that vascular disease, particularly of the small blood vessels, is an important contributor to cognitive impairment and dementia.”

That appears to be most notable in people who have protein in their urine, Dr. Weiner added. “The presence of protein in the urine identifies a severe enough process to affect the blood vessels in the kidney, and there is no reason to think that blood vessels elsewhere in the body, including in the brain, are not similarly affected.”

As for the current study, Dr. Weiner said it could support the vascular disease theory.

“People with vulnerable kidneys to acute injury also have vulnerable brains to acute injury,” he said. “People who get AKI usually have susceptibility to perfusion-related kidney injury. In other words, the small blood vessels that supply the kidney are unable to compensate to maintain sufficient blood flow during a time of low blood pressure or other systemic illness.”

That vulnerability “suggests to me that small blood vessels elsewhere in the body are less likely to be able to respond to challenges like low blood pressure,” Dr. Weiner explained. “If this occurs in the brain, it leads to microvascular disease and greater abnormal white-matter burden. This change in the brain anatomy is highly correlated with cognitive impairment.”

How can physicians put these finding to use? “These patients may require more monitoring,” Dr. Kendrick said. “For example, patients with AKI and complete recovery may not have any follow-up with a nephrologist, and perhaps they should.”

Moving forward, she said, “we are examining the association of AKI with cognitive dysfunction in different patient populations.” Researchers also are planning studies to better understand the mechanisms that are at work, she said.

The National Heart, Lung, and Blood Institute funded the study. The study authors had no disclosures.
 

SOURCE: Kendrick JB et al. Kidney Week 2018. Abstract TH-OR116.

The dogma

Patients with alcohol use disorders (AUD) are at risk for nutritional and vitamin deficiencies and may suffer from linked disease states, including Wernicke’s encephalopathy. These conditions may be underrecognized; for instance, an autopsy study suggests that Wernicke’s encephalopathy may have a prevalence rate of 12.5% among alcoholics.¹

When patients with AUD are hospitalized, they have often already received a standard IV solution (100 mg of thiamine, 1 mg of folate, 1-2 g of magnesium, and a multivitamin dissolved in saline or dextrose). The practice is common enough that the solution is informally referred to as a “banana bag,” due to the yellow hue imparted by thiamine and multivitamin. These fluids might then be readministered daily during the inpatient stay. But what is the evidence supporting this widespread practice?
 

The evidence

While the banana bag (or “rally pack”, as it’s also colloquially known) hanging at the patient’s side may look cool, it may not be helping her. Let’s break down the ingredients:

• Folate: Patients with alcohol use disorder are at higher risk for folate deficiency (attributable to poor intake and decreased absorption), but overall rates of folate deficiency are still quite low.² In addition, most oral and parenteral multivitamins already contain at least 400 mcg folate – the benefit of adding further intravenous folate is not clear.
• Magnesium. Patients with AUD are also at higher risk for magnesium deficiency attributable to increased excretion. While decreased magnesium levels could theoretically increase the risk of alcohol withdrawal symptoms, a Cochrane review found no evidence to support routine supplementation.³
• Multivitamin. Despite theoretical advantages in these (often) malnourished patients, there are no published studies on the benefit or harm of administering a “pan-vitamin” injection. The standard IV formulation is slightly different than an oral vitamin (the IV contains vitamin K, for instance, and lacks calcium), but the bioavailability should be roughly the same, except in rare patients with intestinal malabsorption.⁴
• IV fluids. Pharmacies typically mix these ingredients in a liter of normal saline or 5% dextrose. Once again, though, individual patients will have different needs. A dehydrated patient would benefit more from normal saline, a patient with alcoholic ketoacidosis would benefit more from dextrose, and a patient with alcohol-related cardiomyopathy likely shouldn’t be getting large volume IV fluids at all.
• Thiamine. Thiamine deficiency is likely the most common and most concerning vitamin deficiency in this patient population. The typical banana bag contains 100 mg of thiamine, which has been the traditional recommended daily amount for Wernicke’s treatment. This dosage, however, was apparently chosen arbitrarily in the 1950s (based on what the authors considered to be a high dose) and current recommendations suggest higher doses given more frequently because of the relatively short half-life of parenteral thiamine.⁵

Takeaway

The banana bag is a “one-size-fits-all” approach that offers too much of some of its ingredients and not enough of others. It’s better to individualize treatment based on a patient’s needs and consider high-dose thiamine (500 mg one to three times daily) for those at risk for, or showing signs of, Wernicke’s encephalopathy.

Dr. Sehgal and Dr. Hanson are clinical associate professors of medicine in the division of general and hospital medicine at the South Texas Veterans Health Care System and UT-Health San Antonio. Dr. Sehgal (@rtsehgal) is a member of the editorial advisory board for The Hospitalist.

References

1. Torvik A et al. Brain lesions in alcoholics: a neuropathological study with clinical correlation. J Neurol Sci. 1982 Nov;56(2-3):233-48.

2. Schwab RA et al. Prevalence in folate deficiency in emergency department patients with alcohol-related illness or injury. Am J Emerg Med. 1992 May;10(3):203-7.

3. Sarai M et al. Magnesium for alcohol withdrawal. Cochrane Database Syst Rev. 2013 Jun 5;(6):CD008358.

4. Krishel S et al. Intravenous vitamins for alcoholics in the emergency department: a review. J Emerg Med. 1998 May-Jun;16(3):419-24.

5. Donnino MW et al. Myths and misconceptions of Wernicke’s encephalopathy: what every emergency physician should know. Ann Emerg Med. 2007;50(6): 715-21.

The dogma

Patients with alcohol use disorders (AUD) are at risk for nutritional and vitamin deficiencies and may suffer from linked disease states, including Wernicke’s encephalopathy. These conditions may be underrecognized; for instance, an autopsy study suggests that Wernicke’s encephalopathy may have a prevalence rate of 12.5% among alcoholics.¹

When patients with AUD are hospitalized, they have often already received a standard IV solution (100 mg of thiamine, 1 mg of folate, 1-2 g of magnesium, and a multivitamin dissolved in saline or dextrose). The practice is common enough that the solution is informally referred to as a “banana bag,” due to the yellow hue imparted by thiamine and multivitamin. These fluids might then be readministered daily during the inpatient stay. But what is the evidence supporting this widespread practice?
 

The evidence

While the banana bag (or “rally pack”, as it’s also colloquially known) hanging at the patient’s side may look cool, it may not be helping her. Let’s break down the ingredients:

• Folate: Patients with alcohol use disorder are at higher risk for folate deficiency (attributable to poor intake and decreased absorption), but overall rates of folate deficiency are still quite low.² In addition, most oral and parenteral multivitamins already contain at least 400 mcg folate – the benefit of adding further intravenous folate is not clear.
• Magnesium. Patients with AUD are also at higher risk for magnesium deficiency attributable to increased excretion. While decreased magnesium levels could theoretically increase the risk of alcohol withdrawal symptoms, a Cochrane review found no evidence to support routine supplementation.³
• Multivitamin. Despite theoretical advantages in these (often) malnourished patients, there are no published studies on the benefit or harm of administering a “pan-vitamin” injection. The standard IV formulation is slightly different than an oral vitamin (the IV contains vitamin K, for instance, and lacks calcium), but the bioavailability should be roughly the same, except in rare patients with intestinal malabsorption.⁴
• IV fluids. Pharmacies typically mix these ingredients in a liter of normal saline or 5% dextrose. Once again, though, individual patients will have different needs. A dehydrated patient would benefit more from normal saline, a patient with alcoholic ketoacidosis would benefit more from dextrose, and a patient with alcohol-related cardiomyopathy likely shouldn’t be getting large volume IV fluids at all.
• Thiamine. Thiamine deficiency is likely the most common and most concerning vitamin deficiency in this patient population. The typical banana bag contains 100 mg of thiamine, which has been the traditional recommended daily amount for Wernicke’s treatment. This dosage, however, was apparently chosen arbitrarily in the 1950s (based on what the authors considered to be a high dose) and current recommendations suggest higher doses given more frequently because of the relatively short half-life of parenteral thiamine.⁵

Takeaway

The banana bag is a “one-size-fits-all” approach that offers too much of some of its ingredients and not enough of others. It’s better to individualize treatment based on a patient’s needs and consider high-dose thiamine (500 mg one to three times daily) for those at risk for, or showing signs of, Wernicke’s encephalopathy.

Dr. Sehgal and Dr. Hanson are clinical associate professors of medicine in the division of general and hospital medicine at the South Texas Veterans Health Care System and UT-Health San Antonio. Dr. Sehgal (@rtsehgal) is a member of the editorial advisory board for The Hospitalist.

References

1. Torvik A et al. Brain lesions in alcoholics: a neuropathological study with clinical correlation. J Neurol Sci. 1982 Nov;56(2-3):233-48.

2. Schwab RA et al. Prevalence in folate deficiency in emergency department patients with alcohol-related illness or injury. Am J Emerg Med. 1992 May;10(3):203-7.

3. Sarai M et al. Magnesium for alcohol withdrawal. Cochrane Database Syst Rev. 2013 Jun 5;(6):CD008358.

4. Krishel S et al. Intravenous vitamins for alcoholics in the emergency department: a review. J Emerg Med. 1998 May-Jun;16(3):419-24.

5. Donnino MW et al. Myths and misconceptions of Wernicke’s encephalopathy: what every emergency physician should know. Ann Emerg Med. 2007;50(6): 715-21.

The dogma

Patients with alcohol use disorders (AUD) are at risk for nutritional and vitamin deficiencies and may suffer from linked disease states, including Wernicke’s encephalopathy. These conditions may be underrecognized; for instance, an autopsy study suggests that Wernicke’s encephalopathy may have a prevalence rate of 12.5% among alcoholics.¹

When patients with AUD are hospitalized, they have often already received a standard IV solution (100 mg of thiamine, 1 mg of folate, 1-2 g of magnesium, and a multivitamin dissolved in saline or dextrose). The practice is common enough that the solution is informally referred to as a “banana bag,” due to the yellow hue imparted by thiamine and multivitamin. These fluids might then be readministered daily during the inpatient stay. But what is the evidence supporting this widespread practice?
 

The evidence

While the banana bag (or “rally pack”, as it’s also colloquially known) hanging at the patient’s side may look cool, it may not be helping her. Let’s break down the ingredients:

• Folate: Patients with alcohol use disorder are at higher risk for folate deficiency (attributable to poor intake and decreased absorption), but overall rates of folate deficiency are still quite low.² In addition, most oral and parenteral multivitamins already contain at least 400 mcg folate – the benefit of adding further intravenous folate is not clear.
• Magnesium. Patients with AUD are also at higher risk for magnesium deficiency attributable to increased excretion. While decreased magnesium levels could theoretically increase the risk of alcohol withdrawal symptoms, a Cochrane review found no evidence to support routine supplementation.³
• Multivitamin. Despite theoretical advantages in these (often) malnourished patients, there are no published studies on the benefit or harm of administering a “pan-vitamin” injection. The standard IV formulation is slightly different than an oral vitamin (the IV contains vitamin K, for instance, and lacks calcium), but the bioavailability should be roughly the same, except in rare patients with intestinal malabsorption.⁴
• IV fluids. Pharmacies typically mix these ingredients in a liter of normal saline or 5% dextrose. Once again, though, individual patients will have different needs. A dehydrated patient would benefit more from normal saline, a patient with alcoholic ketoacidosis would benefit more from dextrose, and a patient with alcohol-related cardiomyopathy likely shouldn’t be getting large volume IV fluids at all.
• Thiamine. Thiamine deficiency is likely the most common and most concerning vitamin deficiency in this patient population. The typical banana bag contains 100 mg of thiamine, which has been the traditional recommended daily amount for Wernicke’s treatment. This dosage, however, was apparently chosen arbitrarily in the 1950s (based on what the authors considered to be a high dose) and current recommendations suggest higher doses given more frequently because of the relatively short half-life of parenteral thiamine.⁵

Takeaway

The banana bag is a “one-size-fits-all” approach that offers too much of some of its ingredients and not enough of others. It’s better to individualize treatment based on a patient’s needs and consider high-dose thiamine (500 mg one to three times daily) for those at risk for, or showing signs of, Wernicke’s encephalopathy.

Dr. Sehgal and Dr. Hanson are clinical associate professors of medicine in the division of general and hospital medicine at the South Texas Veterans Health Care System and UT-Health San Antonio. Dr. Sehgal (@rtsehgal) is a member of the editorial advisory board for The Hospitalist.

References

1. Torvik A et al. Brain lesions in alcoholics: a neuropathological study with clinical correlation. J Neurol Sci. 1982 Nov;56(2-3):233-48.

2. Schwab RA et al. Prevalence in folate deficiency in emergency department patients with alcohol-related illness or injury. Am J Emerg Med. 1992 May;10(3):203-7.

3. Sarai M et al. Magnesium for alcohol withdrawal. Cochrane Database Syst Rev. 2013 Jun 5;(6):CD008358.

4. Krishel S et al. Intravenous vitamins for alcoholics in the emergency department: a review. J Emerg Med. 1998 May-Jun;16(3):419-24.

5. Donnino MW et al. Myths and misconceptions of Wernicke’s encephalopathy: what every emergency physician should know. Ann Emerg Med. 2007;50(6): 715-21.

BARCELONA – Amyloid PET brain imaging changed clinical management in 60% of patients with a diagnosis of mild cognitive impairment or dementia and confirmed a presumptive Alzheimer’s diagnosis in 95% of those with positive scans.

But the scans also benefited amyloid-negative patients, Gil Rabinovici, MD, said at the Clinical Trials on Alzheimer’s Disease conference. Before the test, 71% carried an Alzheimer’s disease (AD) diagnosis; after the test, just 10% did, opening the way for an accurate diagnosis and more effective treatment.

“These patients were saved from unnecessary treatment for Alzheimer’s,” said Dr. Rabinovici, the Edward Fein and Pearl Landrith Endowed Professor in Memory & Aging at the University of California, San Francisco. They received more suitable care plans because of the confirmation.

He presented final results of aim one of the IDEAS (Imaging Dementia–Evidence for Amyloid Scanning) study, which seeks to prove that amyloid imaging changes clinical management and improves health outcomes in Medicare beneficiaries who have been diagnosed with mild cognitive impairment (MCI) or dementia of uncertain cause. Its two aims are to show that amyloid PET imaging affects a patient’s care plan within 3 months of the scan and that this impacts major medical outcomes 12 months later. In diagnostically uncertain cases, investigators theorized, amyloid PET imaging would lead to significant changes in patient management, which would then translate into improved medical outcomes.

Ultimately, investigators hope the U.S.-wide, open-label study will prove the clinical value of amyloid PET scanning and convince the Centers for Medicare & Medicaid Services to make the test a fully covered service.

So far, IDEAS has accrued data on 11,409 patients and is quickly closing in on the 18,000-patient target. The patients reported on at CTAD were aged a mean of 75 years and were largely white; only 4% were black and 4% Hispanic. The mean Mini-Mental Scale Exam score was 26. AD was the leading suspect pathology in 73% of the 6,905 with MCI and in 83% of those with dementia of uncertain etiology. Overall, 44% were taking AD medications at baseline.

Scans were positive in 55% of those with MCI and in 70% of those with dementia. Overall, the scans changed clinical management in 61% (7,018), including 60% of those with MCI and 63% of those with dementia.

“We also asked physicians how much the scan results contributed to these changes, and 86.7% replied that they ‘contributed significantly,’ ” Dr. Rabinovici said.

Most changes involved adjustments to medication. AD drugs were started in 44% of MCI patients and in 45% of dementia patients, and non-AD drugs started in 22% and 25%, respectively. About a fifth of the patients received counseling in wake of the scan results.

Medication adjustments also varied by scan result. Among amyloid-positive MCI patients, AD drug use increased from 40% before imaging to 81% after; among amyloid-negative MCI patients, drug use decreased slightly from 27% to 24%. Among amyloid-positive dementia patients, AD drug use increased from 63% to 91%, and among amyloid-negative patients, it dropped from 50% to 44%. All these changes were statistically significant.

The primary diagnosis changed from AD to non-AD in 25%, and from non-AD to AD in 10%. Among amyloid-positive patients, the diagnosis prevalence jumped from 80.0% to 95.5%; among amyloid-negative patients, it dropped from 71% to just 10%.

“IDEAS now provides the strongest data we have supporting the beneficial impact of amyloid PET on patient management,” said Dr. Rabinovici. “Aim two, which is the 12-month health outcomes, we expect to be completed by the end of next year.”

The IDEAS team is also looking at a furthering the investigation with a study called, aptly, “NEW IDEAS.” That would reach out to recruit the minorities that were so underrepresented in the main study and include patients with early-onset MCI or dementia. Building up a library of DNA and blood plasma samples might also fit into the new project.

IDEAS is a funding collaboration of the CMS, the Alzheimer’s Association, Avid Radiopharmaceuticals/Eli Lilly, General Electric Healthcare, Piramal Imaging, and the American College of Radiology. Dr. Rabinovici had no financial disclosures.

msullivan@mdedge.com

BARCELONA – Amyloid PET brain imaging changed clinical management in 60% of patients with a diagnosis of mild cognitive impairment or dementia and confirmed a presumptive Alzheimer’s diagnosis in 95% of those with positive scans.

But the scans also benefited amyloid-negative patients, Gil Rabinovici, MD, said at the Clinical Trials on Alzheimer’s Disease conference. Before the test, 71% carried an Alzheimer’s disease (AD) diagnosis; after the test, just 10% did, opening the way for an accurate diagnosis and more effective treatment.

“These patients were saved from unnecessary treatment for Alzheimer’s,” said Dr. Rabinovici, the Edward Fein and Pearl Landrith Endowed Professor in Memory & Aging at the University of California, San Francisco. They received more suitable care plans because of the confirmation.

He presented final results of aim one of the IDEAS (Imaging Dementia–Evidence for Amyloid Scanning) study, which seeks to prove that amyloid imaging changes clinical management and improves health outcomes in Medicare beneficiaries who have been diagnosed with mild cognitive impairment (MCI) or dementia of uncertain cause. Its two aims are to show that amyloid PET imaging affects a patient’s care plan within 3 months of the scan and that this impacts major medical outcomes 12 months later. In diagnostically uncertain cases, investigators theorized, amyloid PET imaging would lead to significant changes in patient management, which would then translate into improved medical outcomes.

Ultimately, investigators hope the U.S.-wide, open-label study will prove the clinical value of amyloid PET scanning and convince the Centers for Medicare & Medicaid Services to make the test a fully covered service.

So far, IDEAS has accrued data on 11,409 patients and is quickly closing in on the 18,000-patient target. The patients reported on at CTAD were aged a mean of 75 years and were largely white; only 4% were black and 4% Hispanic. The mean Mini-Mental Scale Exam score was 26. AD was the leading suspect pathology in 73% of the 6,905 with MCI and in 83% of those with dementia of uncertain etiology. Overall, 44% were taking AD medications at baseline.

Scans were positive in 55% of those with MCI and in 70% of those with dementia. Overall, the scans changed clinical management in 61% (7,018), including 60% of those with MCI and 63% of those with dementia.

“We also asked physicians how much the scan results contributed to these changes, and 86.7% replied that they ‘contributed significantly,’ ” Dr. Rabinovici said.

Most changes involved adjustments to medication. AD drugs were started in 44% of MCI patients and in 45% of dementia patients, and non-AD drugs started in 22% and 25%, respectively. About a fifth of the patients received counseling in wake of the scan results.

Medication adjustments also varied by scan result. Among amyloid-positive MCI patients, AD drug use increased from 40% before imaging to 81% after; among amyloid-negative MCI patients, drug use decreased slightly from 27% to 24%. Among amyloid-positive dementia patients, AD drug use increased from 63% to 91%, and among amyloid-negative patients, it dropped from 50% to 44%. All these changes were statistically significant.

The primary diagnosis changed from AD to non-AD in 25%, and from non-AD to AD in 10%. Among amyloid-positive patients, the diagnosis prevalence jumped from 80.0% to 95.5%; among amyloid-negative patients, it dropped from 71% to just 10%.

“IDEAS now provides the strongest data we have supporting the beneficial impact of amyloid PET on patient management,” said Dr. Rabinovici. “Aim two, which is the 12-month health outcomes, we expect to be completed by the end of next year.”

The IDEAS team is also looking at a furthering the investigation with a study called, aptly, “NEW IDEAS.” That would reach out to recruit the minorities that were so underrepresented in the main study and include patients with early-onset MCI or dementia. Building up a library of DNA and blood plasma samples might also fit into the new project.

IDEAS is a funding collaboration of the CMS, the Alzheimer’s Association, Avid Radiopharmaceuticals/Eli Lilly, General Electric Healthcare, Piramal Imaging, and the American College of Radiology. Dr. Rabinovici had no financial disclosures.

msullivan@mdedge.com

BARCELONA – Amyloid PET brain imaging changed clinical management in 60% of patients with a diagnosis of mild cognitive impairment or dementia and confirmed a presumptive Alzheimer’s diagnosis in 95% of those with positive scans.

But the scans also benefited amyloid-negative patients, Gil Rabinovici, MD, said at the Clinical Trials on Alzheimer’s Disease conference. Before the test, 71% carried an Alzheimer’s disease (AD) diagnosis; after the test, just 10% did, opening the way for an accurate diagnosis and more effective treatment.

“These patients were saved from unnecessary treatment for Alzheimer’s,” said Dr. Rabinovici, the Edward Fein and Pearl Landrith Endowed Professor in Memory & Aging at the University of California, San Francisco. They received more suitable care plans because of the confirmation.

He presented final results of aim one of the IDEAS (Imaging Dementia–Evidence for Amyloid Scanning) study, which seeks to prove that amyloid imaging changes clinical management and improves health outcomes in Medicare beneficiaries who have been diagnosed with mild cognitive impairment (MCI) or dementia of uncertain cause. Its two aims are to show that amyloid PET imaging affects a patient’s care plan within 3 months of the scan and that this impacts major medical outcomes 12 months later. In diagnostically uncertain cases, investigators theorized, amyloid PET imaging would lead to significant changes in patient management, which would then translate into improved medical outcomes.

Ultimately, investigators hope the U.S.-wide, open-label study will prove the clinical value of amyloid PET scanning and convince the Centers for Medicare & Medicaid Services to make the test a fully covered service.

So far, IDEAS has accrued data on 11,409 patients and is quickly closing in on the 18,000-patient target. The patients reported on at CTAD were aged a mean of 75 years and were largely white; only 4% were black and 4% Hispanic. The mean Mini-Mental Scale Exam score was 26. AD was the leading suspect pathology in 73% of the 6,905 with MCI and in 83% of those with dementia of uncertain etiology. Overall, 44% were taking AD medications at baseline.

Scans were positive in 55% of those with MCI and in 70% of those with dementia. Overall, the scans changed clinical management in 61% (7,018), including 60% of those with MCI and 63% of those with dementia.

“We also asked physicians how much the scan results contributed to these changes, and 86.7% replied that they ‘contributed significantly,’ ” Dr. Rabinovici said.

Most changes involved adjustments to medication. AD drugs were started in 44% of MCI patients and in 45% of dementia patients, and non-AD drugs started in 22% and 25%, respectively. About a fifth of the patients received counseling in wake of the scan results.

Medication adjustments also varied by scan result. Among amyloid-positive MCI patients, AD drug use increased from 40% before imaging to 81% after; among amyloid-negative MCI patients, drug use decreased slightly from 27% to 24%. Among amyloid-positive dementia patients, AD drug use increased from 63% to 91%, and among amyloid-negative patients, it dropped from 50% to 44%. All these changes were statistically significant.

The primary diagnosis changed from AD to non-AD in 25%, and from non-AD to AD in 10%. Among amyloid-positive patients, the diagnosis prevalence jumped from 80.0% to 95.5%; among amyloid-negative patients, it dropped from 71% to just 10%.

“IDEAS now provides the strongest data we have supporting the beneficial impact of amyloid PET on patient management,” said Dr. Rabinovici. “Aim two, which is the 12-month health outcomes, we expect to be completed by the end of next year.”

The IDEAS team is also looking at a furthering the investigation with a study called, aptly, “NEW IDEAS.” That would reach out to recruit the minorities that were so underrepresented in the main study and include patients with early-onset MCI or dementia. Building up a library of DNA and blood plasma samples might also fit into the new project.

IDEAS is a funding collaboration of the CMS, the Alzheimer’s Association, Avid Radiopharmaceuticals/Eli Lilly, General Electric Healthcare, Piramal Imaging, and the American College of Radiology. Dr. Rabinovici had no financial disclosures.

msullivan@mdedge.com

ATLANTA – Acute myocardial infarction is associated with a risk of stroke that extends beyond the 1-month time window currently considered the at-risk period, according to an analysis of Medicare data.

“The results of our study may allow clinicians to more accurately counsel patients regarding their stroke etiology and may allow refinement of stroke etiology classification systems and clinical trial selection criteria,” lead study author Alexander E. Merkler, MD, said in an interview in advance of the annual meeting of the American Neurological Association.

In an effort to better understand the duration of heightened stroke risk after acute myocardial infarction, Dr. Merkler, a neurologist at New York–based Weill Cornell Medicine, and his colleagues conducted a retrospective cohort study using inpatient and outpatient claims during 2008-2015 from a nationally representative 5% sample of Medicare beneficiaries who were at least 66 years old. They used previously validated ICD-9-CM diagnosis codes to ascertain the exposure variable of acute MI and the outcome of ischemic stroke but excluded strokes that occurred during an acute MI hospitalization.


Patients were censored at the time of ischemic stroke, death, end of Medicare coverage, or by Sept. 30, 2015. The researchers fit Cox regression models separately for the groups with and without acute MI to examine its association with ischemic stroke after adjusting for demographics, stroke risk factors, and Charlson comorbidities. Next, they used the corresponding survival probabilities to compute the hazard ratio (HR) in each 4-week interval after discharge, up to week 12. They also conducted a subgroup analysis to evaluate the duration of heightened ischemic stroke risk by MI type: ST-segment elevation MI (STEMI) versus non-STEMI (NSTEMI).

Dr. Merkler and his colleagues drew from data on 1.7 million eligible beneficiaries. Of these, 46,182 were hospitalized for acute MI and 80,466 for ischemic stroke. After they adjusted for demographics, stroke risk factors, and Charlson comorbidities, the researchers found that the risk of ischemic stroke was highest in the first 4 weeks after discharge from the MI hospitalization (HR, 2.7), yet remained elevated during weeks 5-8 (HR, 2.0) and weeks 9-12 (HR, 1.6). It was no longer significantly elevated afterward. The prolonged period of heightened ischemic stroke risk was evident in patients with both STEMI and NSTEMI.

“We were surprised by how long the risk of stroke lasts after MI,” Dr. Merkler said. He acknowledged certain limitations of the analysis, including the fact that patients were all over the age of 65 years. “In addition, we lack granular detail such as severity of MI [and] the extent of stroke work-up,” he said.

Dr. Merkler disclosed that he is supported by a grant from the National Institutes of Health and by the Leon Levy Foundation in Neuroscience. Most of his coauthors are also supported by NIH grants.

dbrunk@mdedge.com

Source: Ann Neurol. 2018;84[S22]:S146-7, Abstract M122.

ATLANTA – Acute myocardial infarction is associated with a risk of stroke that extends beyond the 1-month time window currently considered the at-risk period, according to an analysis of Medicare data.

“The results of our study may allow clinicians to more accurately counsel patients regarding their stroke etiology and may allow refinement of stroke etiology classification systems and clinical trial selection criteria,” lead study author Alexander E. Merkler, MD, said in an interview in advance of the annual meeting of the American Neurological Association.

In an effort to better understand the duration of heightened stroke risk after acute myocardial infarction, Dr. Merkler, a neurologist at New York–based Weill Cornell Medicine, and his colleagues conducted a retrospective cohort study using inpatient and outpatient claims during 2008-2015 from a nationally representative 5% sample of Medicare beneficiaries who were at least 66 years old. They used previously validated ICD-9-CM diagnosis codes to ascertain the exposure variable of acute MI and the outcome of ischemic stroke but excluded strokes that occurred during an acute MI hospitalization.


Patients were censored at the time of ischemic stroke, death, end of Medicare coverage, or by Sept. 30, 2015. The researchers fit Cox regression models separately for the groups with and without acute MI to examine its association with ischemic stroke after adjusting for demographics, stroke risk factors, and Charlson comorbidities. Next, they used the corresponding survival probabilities to compute the hazard ratio (HR) in each 4-week interval after discharge, up to week 12. They also conducted a subgroup analysis to evaluate the duration of heightened ischemic stroke risk by MI type: ST-segment elevation MI (STEMI) versus non-STEMI (NSTEMI).

Dr. Merkler and his colleagues drew from data on 1.7 million eligible beneficiaries. Of these, 46,182 were hospitalized for acute MI and 80,466 for ischemic stroke. After they adjusted for demographics, stroke risk factors, and Charlson comorbidities, the researchers found that the risk of ischemic stroke was highest in the first 4 weeks after discharge from the MI hospitalization (HR, 2.7), yet remained elevated during weeks 5-8 (HR, 2.0) and weeks 9-12 (HR, 1.6). It was no longer significantly elevated afterward. The prolonged period of heightened ischemic stroke risk was evident in patients with both STEMI and NSTEMI.

“We were surprised by how long the risk of stroke lasts after MI,” Dr. Merkler said. He acknowledged certain limitations of the analysis, including the fact that patients were all over the age of 65 years. “In addition, we lack granular detail such as severity of MI [and] the extent of stroke work-up,” he said.

Dr. Merkler disclosed that he is supported by a grant from the National Institutes of Health and by the Leon Levy Foundation in Neuroscience. Most of his coauthors are also supported by NIH grants.

dbrunk@mdedge.com

Source: Ann Neurol. 2018;84[S22]:S146-7, Abstract M122.

ATLANTA – Acute myocardial infarction is associated with a risk of stroke that extends beyond the 1-month time window currently considered the at-risk period, according to an analysis of Medicare data.

“The results of our study may allow clinicians to more accurately counsel patients regarding their stroke etiology and may allow refinement of stroke etiology classification systems and clinical trial selection criteria,” lead study author Alexander E. Merkler, MD, said in an interview in advance of the annual meeting of the American Neurological Association.

In an effort to better understand the duration of heightened stroke risk after acute myocardial infarction, Dr. Merkler, a neurologist at New York–based Weill Cornell Medicine, and his colleagues conducted a retrospective cohort study using inpatient and outpatient claims during 2008-2015 from a nationally representative 5% sample of Medicare beneficiaries who were at least 66 years old. They used previously validated ICD-9-CM diagnosis codes to ascertain the exposure variable of acute MI and the outcome of ischemic stroke but excluded strokes that occurred during an acute MI hospitalization.


Patients were censored at the time of ischemic stroke, death, end of Medicare coverage, or by Sept. 30, 2015. The researchers fit Cox regression models separately for the groups with and without acute MI to examine its association with ischemic stroke after adjusting for demographics, stroke risk factors, and Charlson comorbidities. Next, they used the corresponding survival probabilities to compute the hazard ratio (HR) in each 4-week interval after discharge, up to week 12. They also conducted a subgroup analysis to evaluate the duration of heightened ischemic stroke risk by MI type: ST-segment elevation MI (STEMI) versus non-STEMI (NSTEMI).

Dr. Merkler and his colleagues drew from data on 1.7 million eligible beneficiaries. Of these, 46,182 were hospitalized for acute MI and 80,466 for ischemic stroke. After they adjusted for demographics, stroke risk factors, and Charlson comorbidities, the researchers found that the risk of ischemic stroke was highest in the first 4 weeks after discharge from the MI hospitalization (HR, 2.7), yet remained elevated during weeks 5-8 (HR, 2.0) and weeks 9-12 (HR, 1.6). It was no longer significantly elevated afterward. The prolonged period of heightened ischemic stroke risk was evident in patients with both STEMI and NSTEMI.

“We were surprised by how long the risk of stroke lasts after MI,” Dr. Merkler said. He acknowledged certain limitations of the analysis, including the fact that patients were all over the age of 65 years. “In addition, we lack granular detail such as severity of MI [and] the extent of stroke work-up,” he said.

Dr. Merkler disclosed that he is supported by a grant from the National Institutes of Health and by the Leon Levy Foundation in Neuroscience. Most of his coauthors are also supported by NIH grants.

dbrunk@mdedge.com

Source: Ann Neurol. 2018;84[S22]:S146-7, Abstract M122.

WASHINGTON – Ataxia is the most common symptom at disease onset in patients with opsoclonus-myoclonus syndrome (OMS), a rare disease affecting only 1 in 5,000,000 individuals, mostly aged 1-5 years, based on data from a new patient registry.

In partnership with the National Organization of Rare Disorders (NORD) the nonprofit OMSLife Foundation has created a patient registry to better understand the disease experience in patients, wrote Mike Michaelis, chairman of OMSLife, and his colleagues. Early data from 275 enrolled patients were presented in a poster at the NORD Rare Summit, held by the National Organization for Rare Disorders.

The registry patients were mainly born in the United States (86%) and white (74%); approximately half were female. Of 150 patients who indicated symptoms at onset, 87% reported ataxia. Additional symptoms at onset were myoclonus (61%), opsoclonus (59%), tremors (46%), sleep disturbances (45%), temper tantrums (38%), vomiting (27%), fever (13%), headache (9%) and other symptoms (13%).

The researchers reviewed associations of symptoms at onset to determine the frequency of other symptoms for each individual symptom. Ataxia was present with 89% or higher instances of the other reported symptoms. Of note, some symptoms occurred more frequently than expected, such as temper tantrums and tremors in approximately 70% of patients with sleep disturbances. Myoclonus and opsoclonus, as well as fever and vomiting, also were significantly associated with the presence of other symptoms.

Two-thirds of the registry patients (69%) were diagnosed within 3 months of symptom onset, and 83% of these were diagnosed by a neurologist. Based on the Mitchell-Pike OMS severity scale, 59% of the patients met criteria for severe disease, 34% were classified as moderate, and 7% were mild. The registry is ongoing, but the current data provide insight on the clinical picture and common symptoms of OMS, the researchers said.

OMS Life was established in 2012 to support patients, caregivers, and researchers in raising awareness of opsoclonus-myoclonus syndrome as well as funds for research.

The study was supported by the OMSLife Foundation, NORD, and Trio Health Analytics. The researchers are employed by these organizations.

WASHINGTON – Ataxia is the most common symptom at disease onset in patients with opsoclonus-myoclonus syndrome (OMS), a rare disease affecting only 1 in 5,000,000 individuals, mostly aged 1-5 years, based on data from a new patient registry.

In partnership with the National Organization of Rare Disorders (NORD) the nonprofit OMSLife Foundation has created a patient registry to better understand the disease experience in patients, wrote Mike Michaelis, chairman of OMSLife, and his colleagues. Early data from 275 enrolled patients were presented in a poster at the NORD Rare Summit, held by the National Organization for Rare Disorders.

The registry patients were mainly born in the United States (86%) and white (74%); approximately half were female. Of 150 patients who indicated symptoms at onset, 87% reported ataxia. Additional symptoms at onset were myoclonus (61%), opsoclonus (59%), tremors (46%), sleep disturbances (45%), temper tantrums (38%), vomiting (27%), fever (13%), headache (9%) and other symptoms (13%).

The researchers reviewed associations of symptoms at onset to determine the frequency of other symptoms for each individual symptom. Ataxia was present with 89% or higher instances of the other reported symptoms. Of note, some symptoms occurred more frequently than expected, such as temper tantrums and tremors in approximately 70% of patients with sleep disturbances. Myoclonus and opsoclonus, as well as fever and vomiting, also were significantly associated with the presence of other symptoms.

Two-thirds of the registry patients (69%) were diagnosed within 3 months of symptom onset, and 83% of these were diagnosed by a neurologist. Based on the Mitchell-Pike OMS severity scale, 59% of the patients met criteria for severe disease, 34% were classified as moderate, and 7% were mild. The registry is ongoing, but the current data provide insight on the clinical picture and common symptoms of OMS, the researchers said.

OMS Life was established in 2012 to support patients, caregivers, and researchers in raising awareness of opsoclonus-myoclonus syndrome as well as funds for research.

The study was supported by the OMSLife Foundation, NORD, and Trio Health Analytics. The researchers are employed by these organizations.

WASHINGTON – Ataxia is the most common symptom at disease onset in patients with opsoclonus-myoclonus syndrome (OMS), a rare disease affecting only 1 in 5,000,000 individuals, mostly aged 1-5 years, based on data from a new patient registry.

In partnership with the National Organization of Rare Disorders (NORD) the nonprofit OMSLife Foundation has created a patient registry to better understand the disease experience in patients, wrote Mike Michaelis, chairman of OMSLife, and his colleagues. Early data from 275 enrolled patients were presented in a poster at the NORD Rare Summit, held by the National Organization for Rare Disorders.

The registry patients were mainly born in the United States (86%) and white (74%); approximately half were female. Of 150 patients who indicated symptoms at onset, 87% reported ataxia. Additional symptoms at onset were myoclonus (61%), opsoclonus (59%), tremors (46%), sleep disturbances (45%), temper tantrums (38%), vomiting (27%), fever (13%), headache (9%) and other symptoms (13%).

The researchers reviewed associations of symptoms at onset to determine the frequency of other symptoms for each individual symptom. Ataxia was present with 89% or higher instances of the other reported symptoms. Of note, some symptoms occurred more frequently than expected, such as temper tantrums and tremors in approximately 70% of patients with sleep disturbances. Myoclonus and opsoclonus, as well as fever and vomiting, also were significantly associated with the presence of other symptoms.

Two-thirds of the registry patients (69%) were diagnosed within 3 months of symptom onset, and 83% of these were diagnosed by a neurologist. Based on the Mitchell-Pike OMS severity scale, 59% of the patients met criteria for severe disease, 34% were classified as moderate, and 7% were mild. The registry is ongoing, but the current data provide insight on the clinical picture and common symptoms of OMS, the researchers said.

OMS Life was established in 2012 to support patients, caregivers, and researchers in raising awareness of opsoclonus-myoclonus syndrome as well as funds for research.

The study was supported by the OMSLife Foundation, NORD, and Trio Health Analytics. The researchers are employed by these organizations.

Overall drug overdose deaths may have peaked at the end of last year, as the most recent data show a drop of almost 3% in 12-month ending counts from November 2017 to March 2018, according to the National Center for Health Statistics.

Longer-term data, however, show an increase over the year from March 2017 to March 2018, as the short-term decrease was not enough to overcome the previous year’s increase. The provisional 12-month ending count – deaths during the 12-month period ending in the month indicated – went from 66,859 in March 2017 to 68,690 in March 2018, an increase of 2.7%, the NCHS reported.

That year-long increase was not spread evenly among the states. Nebraska’s 12-month ending count jumped over 48% from March 2017 to March 2018, more than twice as much as second-place Hawaii’s 20.9%. Montana had the largest drop over that year, –24.2%, with Wyoming next at –20.7% and the District of Columbia third at –14.8%, data from the National Vital Statistics System show.

“Provisional drug overdose death data are often incomplete,” the NCHS noted, “and the degree of completeness varies by jurisdiction and 12-month ending period. Consequently, the numbers of drug overdose deaths are underestimated, based on provisional data relative to final data and are subject to random variation.”
 

rfranki@mdedge.com

Overall drug overdose deaths may have peaked at the end of last year, as the most recent data show a drop of almost 3% in 12-month ending counts from November 2017 to March 2018, according to the National Center for Health Statistics.

Longer-term data, however, show an increase over the year from March 2017 to March 2018, as the short-term decrease was not enough to overcome the previous year’s increase. The provisional 12-month ending count – deaths during the 12-month period ending in the month indicated – went from 66,859 in March 2017 to 68,690 in March 2018, an increase of 2.7%, the NCHS reported.

That year-long increase was not spread evenly among the states. Nebraska’s 12-month ending count jumped over 48% from March 2017 to March 2018, more than twice as much as second-place Hawaii’s 20.9%. Montana had the largest drop over that year, –24.2%, with Wyoming next at –20.7% and the District of Columbia third at –14.8%, data from the National Vital Statistics System show.

“Provisional drug overdose death data are often incomplete,” the NCHS noted, “and the degree of completeness varies by jurisdiction and 12-month ending period. Consequently, the numbers of drug overdose deaths are underestimated, based on provisional data relative to final data and are subject to random variation.”
 

rfranki@mdedge.com

Overall drug overdose deaths may have peaked at the end of last year, as the most recent data show a drop of almost 3% in 12-month ending counts from November 2017 to March 2018, according to the National Center for Health Statistics.

Longer-term data, however, show an increase over the year from March 2017 to March 2018, as the short-term decrease was not enough to overcome the previous year’s increase. The provisional 12-month ending count – deaths during the 12-month period ending in the month indicated – went from 66,859 in March 2017 to 68,690 in March 2018, an increase of 2.7%, the NCHS reported.

That year-long increase was not spread evenly among the states. Nebraska’s 12-month ending count jumped over 48% from March 2017 to March 2018, more than twice as much as second-place Hawaii’s 20.9%. Montana had the largest drop over that year, –24.2%, with Wyoming next at –20.7% and the District of Columbia third at –14.8%, data from the National Vital Statistics System show.

“Provisional drug overdose death data are often incomplete,” the NCHS noted, “and the degree of completeness varies by jurisdiction and 12-month ending period. Consequently, the numbers of drug overdose deaths are underestimated, based on provisional data relative to final data and are subject to random variation.”
 

rfranki@mdedge.com

ATLANTA – Following an acute stroke, optimizing stroke secondary prevention measures, medical complications, and transitions of care is essential to reducing 30-day readmissions and improving patient outcomes, a large analysis of national data showed.

Doug Brunk/MDedge News

“Care that is fragmented with readmissions to other hospitals results not only in more expensive care and longer length of stay but also increased mortality for our acute stroke patients,” lead study author Laura K. Stein, MD, said in an interview in advance of the annual meeting of the American Neurological Association.

In 2017, a study of the Nationwide Readmissions Database demonstrated that 12.1% of patients with acute ischemic stroke were readmitted within 30 days (Stroke 2017;48:1386-8). It cited that 89.6% were unplanned and 12.9% were preventable. “However, this study did not examine whether patients were admitted to the discharging hospital or a different hospital,” said Dr. Stein, a neurologist at the Icahn School of Medicine at Mount Sinai, New York. “Furthermore, it did not include metrics such as cost, length of stay, and mortality with 30-day readmissions. Hospitals are increasingly held accountable and penalized for metrics such as length of stay and 30-day readmissions.”

In 2010, the Centers for Medicare & Medicaid Services introduced the Hospital Readmissions Reduction Program in an attempt to decrease readmissions following hospitalizations for acute myocardial infarction, heart failure, and pneumonia. “In 2012, CMS started reducing Medicare payments for hospitals with excess readmissions,” said Dr. Stein, who is a fellowship-trained stroke specialist. “While readmission to the same hospital has great implications for hospital systems, any readmission has great implications for patients.”

In what is believed to be the first study of its kind, Dr. Stein and her colleagues drew from the 2013 Nationwide Readmissions Database to examine in-hospital outcomes associated with 30-day readmission to a different hospital for acute ischemic stroke. They used ICD-9 codes to identify index stroke admissions and all-cause readmissions. Outcomes of interest were length of stay, total charges, and in-hospital mortality during the 30-day readmission. The main predictor was readmission to another hospital, compared with readmission to the same hospital as the index acute stroke admission. The researchers used linear regression for the outcomes of length of stay and charges, and logistic regression for in-hospital mortality. They adjusted for several variables during the index admission, including age, sex, vascular risk factors, hospital bed size, teaching hospital status, insurance status, discharge destination, National Center for Health Statistics urban-rural location classification, length of stay, and total charges.

Of 24,545 acute stroke patients readmitted within 30 days, 7,274 (30%) were readmitted to a different hospital. The top three reasons for readmission were acute cerebrovascular disease, septicemia, and renal failure. In fully adjusted models, readmission to a different hospital was associated with an increased length of stay of 0.97 days (P less than .0001) and a mean of $7,677.28 greater total charges, compared with readmission to the same hospital (P less than .0001). The fully adjusted odds ratio for in-hospital mortality during readmission was 1.17 for readmission to another hospital vs. readmission to the same hospital (P = .0079).

“While it is conceivable that cost and length of stay could be higher with readmission to a different hospital because of a need for additional testing with a lack of familiarity with the patient, it is concerning that mortality is higher,” Dr. Stein said. “These findings emphasize the importance of optimizing secondary stroke prevention and medical complications following acute stroke before discharge. Additionally, they emphasize the importance of good transitions of care from the inpatient to outpatient setting (whether that’s to a rehabilitation facility, skilled nursing facility, or home) and accessibility of the discharging stroke team after discharge.”

She acknowledged certain limitations of the analysis, including its reliance of administrative data, which could include misclassification of diagnoses and comorbidities based on ICD-9 codes. “However, we have chosen ICD-9 codes for stroke that have been previously validated in the literature,” Dr. Stein said. “For instance, the validated codes for stroke as the primary discharge diagnosis have a sensitivity of 74%, specificity of 95%, and positive predictive value of 88%. Second, we do not know stroke subtype or severity of stroke. Third, we do not know what the transitions of care plan were when the patients left the hospital following index acute ischemic stroke admission and why these patients ended up being readmitted to a different hospital rather than the one that treated them for their acute stroke.”

The researchers reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Stein L et al. Ann Neurol. 2018;84[S22]:S149. Abstract M127.

ATLANTA – Following an acute stroke, optimizing stroke secondary prevention measures, medical complications, and transitions of care is essential to reducing 30-day readmissions and improving patient outcomes, a large analysis of national data showed.

Doug Brunk/MDedge News

“Care that is fragmented with readmissions to other hospitals results not only in more expensive care and longer length of stay but also increased mortality for our acute stroke patients,” lead study author Laura K. Stein, MD, said in an interview in advance of the annual meeting of the American Neurological Association.

In 2017, a study of the Nationwide Readmissions Database demonstrated that 12.1% of patients with acute ischemic stroke were readmitted within 30 days (Stroke 2017;48:1386-8). It cited that 89.6% were unplanned and 12.9% were preventable. “However, this study did not examine whether patients were admitted to the discharging hospital or a different hospital,” said Dr. Stein, a neurologist at the Icahn School of Medicine at Mount Sinai, New York. “Furthermore, it did not include metrics such as cost, length of stay, and mortality with 30-day readmissions. Hospitals are increasingly held accountable and penalized for metrics such as length of stay and 30-day readmissions.”

In 2010, the Centers for Medicare & Medicaid Services introduced the Hospital Readmissions Reduction Program in an attempt to decrease readmissions following hospitalizations for acute myocardial infarction, heart failure, and pneumonia. “In 2012, CMS started reducing Medicare payments for hospitals with excess readmissions,” said Dr. Stein, who is a fellowship-trained stroke specialist. “While readmission to the same hospital has great implications for hospital systems, any readmission has great implications for patients.”

In what is believed to be the first study of its kind, Dr. Stein and her colleagues drew from the 2013 Nationwide Readmissions Database to examine in-hospital outcomes associated with 30-day readmission to a different hospital for acute ischemic stroke. They used ICD-9 codes to identify index stroke admissions and all-cause readmissions. Outcomes of interest were length of stay, total charges, and in-hospital mortality during the 30-day readmission. The main predictor was readmission to another hospital, compared with readmission to the same hospital as the index acute stroke admission. The researchers used linear regression for the outcomes of length of stay and charges, and logistic regression for in-hospital mortality. They adjusted for several variables during the index admission, including age, sex, vascular risk factors, hospital bed size, teaching hospital status, insurance status, discharge destination, National Center for Health Statistics urban-rural location classification, length of stay, and total charges.

Of 24,545 acute stroke patients readmitted within 30 days, 7,274 (30%) were readmitted to a different hospital. The top three reasons for readmission were acute cerebrovascular disease, septicemia, and renal failure. In fully adjusted models, readmission to a different hospital was associated with an increased length of stay of 0.97 days (P less than .0001) and a mean of $7,677.28 greater total charges, compared with readmission to the same hospital (P less than .0001). The fully adjusted odds ratio for in-hospital mortality during readmission was 1.17 for readmission to another hospital vs. readmission to the same hospital (P = .0079).

“While it is conceivable that cost and length of stay could be higher with readmission to a different hospital because of a need for additional testing with a lack of familiarity with the patient, it is concerning that mortality is higher,” Dr. Stein said. “These findings emphasize the importance of optimizing secondary stroke prevention and medical complications following acute stroke before discharge. Additionally, they emphasize the importance of good transitions of care from the inpatient to outpatient setting (whether that’s to a rehabilitation facility, skilled nursing facility, or home) and accessibility of the discharging stroke team after discharge.”

She acknowledged certain limitations of the analysis, including its reliance of administrative data, which could include misclassification of diagnoses and comorbidities based on ICD-9 codes. “However, we have chosen ICD-9 codes for stroke that have been previously validated in the literature,” Dr. Stein said. “For instance, the validated codes for stroke as the primary discharge diagnosis have a sensitivity of 74%, specificity of 95%, and positive predictive value of 88%. Second, we do not know stroke subtype or severity of stroke. Third, we do not know what the transitions of care plan were when the patients left the hospital following index acute ischemic stroke admission and why these patients ended up being readmitted to a different hospital rather than the one that treated them for their acute stroke.”

The researchers reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Stein L et al. Ann Neurol. 2018;84[S22]:S149. Abstract M127.

ATLANTA – Following an acute stroke, optimizing stroke secondary prevention measures, medical complications, and transitions of care is essential to reducing 30-day readmissions and improving patient outcomes, a large analysis of national data showed.

Doug Brunk/MDedge News

“Care that is fragmented with readmissions to other hospitals results not only in more expensive care and longer length of stay but also increased mortality for our acute stroke patients,” lead study author Laura K. Stein, MD, said in an interview in advance of the annual meeting of the American Neurological Association.

In 2017, a study of the Nationwide Readmissions Database demonstrated that 12.1% of patients with acute ischemic stroke were readmitted within 30 days (Stroke 2017;48:1386-8). It cited that 89.6% were unplanned and 12.9% were preventable. “However, this study did not examine whether patients were admitted to the discharging hospital or a different hospital,” said Dr. Stein, a neurologist at the Icahn School of Medicine at Mount Sinai, New York. “Furthermore, it did not include metrics such as cost, length of stay, and mortality with 30-day readmissions. Hospitals are increasingly held accountable and penalized for metrics such as length of stay and 30-day readmissions.”

In 2010, the Centers for Medicare & Medicaid Services introduced the Hospital Readmissions Reduction Program in an attempt to decrease readmissions following hospitalizations for acute myocardial infarction, heart failure, and pneumonia. “In 2012, CMS started reducing Medicare payments for hospitals with excess readmissions,” said Dr. Stein, who is a fellowship-trained stroke specialist. “While readmission to the same hospital has great implications for hospital systems, any readmission has great implications for patients.”

In what is believed to be the first study of its kind, Dr. Stein and her colleagues drew from the 2013 Nationwide Readmissions Database to examine in-hospital outcomes associated with 30-day readmission to a different hospital for acute ischemic stroke. They used ICD-9 codes to identify index stroke admissions and all-cause readmissions. Outcomes of interest were length of stay, total charges, and in-hospital mortality during the 30-day readmission. The main predictor was readmission to another hospital, compared with readmission to the same hospital as the index acute stroke admission. The researchers used linear regression for the outcomes of length of stay and charges, and logistic regression for in-hospital mortality. They adjusted for several variables during the index admission, including age, sex, vascular risk factors, hospital bed size, teaching hospital status, insurance status, discharge destination, National Center for Health Statistics urban-rural location classification, length of stay, and total charges.

Of 24,545 acute stroke patients readmitted within 30 days, 7,274 (30%) were readmitted to a different hospital. The top three reasons for readmission were acute cerebrovascular disease, septicemia, and renal failure. In fully adjusted models, readmission to a different hospital was associated with an increased length of stay of 0.97 days (P less than .0001) and a mean of $7,677.28 greater total charges, compared with readmission to the same hospital (P less than .0001). The fully adjusted odds ratio for in-hospital mortality during readmission was 1.17 for readmission to another hospital vs. readmission to the same hospital (P = .0079).

“While it is conceivable that cost and length of stay could be higher with readmission to a different hospital because of a need for additional testing with a lack of familiarity with the patient, it is concerning that mortality is higher,” Dr. Stein said. “These findings emphasize the importance of optimizing secondary stroke prevention and medical complications following acute stroke before discharge. Additionally, they emphasize the importance of good transitions of care from the inpatient to outpatient setting (whether that’s to a rehabilitation facility, skilled nursing facility, or home) and accessibility of the discharging stroke team after discharge.”

She acknowledged certain limitations of the analysis, including its reliance of administrative data, which could include misclassification of diagnoses and comorbidities based on ICD-9 codes. “However, we have chosen ICD-9 codes for stroke that have been previously validated in the literature,” Dr. Stein said. “For instance, the validated codes for stroke as the primary discharge diagnosis have a sensitivity of 74%, specificity of 95%, and positive predictive value of 88%. Second, we do not know stroke subtype or severity of stroke. Third, we do not know what the transitions of care plan were when the patients left the hospital following index acute ischemic stroke admission and why these patients ended up being readmitted to a different hospital rather than the one that treated them for their acute stroke.”

The researchers reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Stein L et al. Ann Neurol. 2018;84[S22]:S149. Abstract M127.

SAN DIEGO – A biomarker test based on the presence of two proteins in the blood appears to be suitable for ruling out significant intracranial injuries in patients with a history of mild traumatic brain injury (TBI) without the need for a CT head scan, according to data presented at the annual meeting of the American College of Emergency Physicians.

Ted Bosworth/MDedge News

A biomarker suitable for ruling out significant brain injury could save substantial resources because only about 10% of patients with mild TBI have a positive CT head scan, according to Jeffrey J. Bazarian, MD, professor of emergency medicine, University of Rochester (New York).

In the ALERT-TBI study, which evaluated the biomarker test, 1,959 patients with suspected TBI at 22 participating EDs in the United States and Europe were enrolled and available for analysis. All had mild TBI as defined as a Glasgow Coma Scale (GCS) score of 13-15.

The treating ED physician’s decision to order a head CT scan was the major criterion for study entry. All enrolled patients had their blood drawn within 12 hours in order to quantify two biomarkers, C-terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP).

The biomarker test for TBI was negative when the UCH-L1 value was less than 327 pg/mL and the GFAP was less than 22 pg/mL; the test was positive if either value was at this threshold or higher. To evaluate the sensitivity and specificity of this dual-biomarker test, results were correlated with head CT scans read by two neurologists blinded to the biomarker values.

The mean age of the study population was 48.8 years and slightly more than half were male. About half of the suspected TBI in these patients was attributed to falls and about one third to motor vehicle accidents.

Typical of TBI with GCS scores in the mild range, only 6% of the patients had a positive CT head scan. Of the 125 positive CT scans, the most common injury detected on CT scan was subarachnoid hemorrhage followed by subdural hematoma.

Of the 671 negative biomarker tests, 668 had normal head CT scans. Of the three false positives, one included a cavernous malformation that may have been present prior to the TBI. The others were a small subarachnoid hemorrhage and a small subdural hematoma. Overall the negative predictive value was 99.6% and the sensitivity was 97.6%.

Although the biomarker specificity was only 36% with an even-lower positive predictive value, the goal of the test was to rule out significant TBI to avoid the need for CT scan. On this basis, the biomarker test, which is being developed under the proprietary name Banyan BTI, appears to be promising. The data, according to Dr. Bazarian, have been submitted to the Food and Drug Administration.

“Head CT scans are the current standard for evaluating intracranial injuries after TBI, but they are overused, based on the high proportion that do not show an injury,” said Dr. Bazarian. Although he does not know the disposition of the FDA application, he said, based on these data, “I would definitely be using this test if it were available.”

SAN DIEGO – A biomarker test based on the presence of two proteins in the blood appears to be suitable for ruling out significant intracranial injuries in patients with a history of mild traumatic brain injury (TBI) without the need for a CT head scan, according to data presented at the annual meeting of the American College of Emergency Physicians.

Ted Bosworth/MDedge News

A biomarker suitable for ruling out significant brain injury could save substantial resources because only about 10% of patients with mild TBI have a positive CT head scan, according to Jeffrey J. Bazarian, MD, professor of emergency medicine, University of Rochester (New York).

In the ALERT-TBI study, which evaluated the biomarker test, 1,959 patients with suspected TBI at 22 participating EDs in the United States and Europe were enrolled and available for analysis. All had mild TBI as defined as a Glasgow Coma Scale (GCS) score of 13-15.

The treating ED physician’s decision to order a head CT scan was the major criterion for study entry. All enrolled patients had their blood drawn within 12 hours in order to quantify two biomarkers, C-terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP).

The biomarker test for TBI was negative when the UCH-L1 value was less than 327 pg/mL and the GFAP was less than 22 pg/mL; the test was positive if either value was at this threshold or higher. To evaluate the sensitivity and specificity of this dual-biomarker test, results were correlated with head CT scans read by two neurologists blinded to the biomarker values.

The mean age of the study population was 48.8 years and slightly more than half were male. About half of the suspected TBI in these patients was attributed to falls and about one third to motor vehicle accidents.

Typical of TBI with GCS scores in the mild range, only 6% of the patients had a positive CT head scan. Of the 125 positive CT scans, the most common injury detected on CT scan was subarachnoid hemorrhage followed by subdural hematoma.

Of the 671 negative biomarker tests, 668 had normal head CT scans. Of the three false positives, one included a cavernous malformation that may have been present prior to the TBI. The others were a small subarachnoid hemorrhage and a small subdural hematoma. Overall the negative predictive value was 99.6% and the sensitivity was 97.6%.

Although the biomarker specificity was only 36% with an even-lower positive predictive value, the goal of the test was to rule out significant TBI to avoid the need for CT scan. On this basis, the biomarker test, which is being developed under the proprietary name Banyan BTI, appears to be promising. The data, according to Dr. Bazarian, have been submitted to the Food and Drug Administration.

“Head CT scans are the current standard for evaluating intracranial injuries after TBI, but they are overused, based on the high proportion that do not show an injury,” said Dr. Bazarian. Although he does not know the disposition of the FDA application, he said, based on these data, “I would definitely be using this test if it were available.”

SAN DIEGO – A biomarker test based on the presence of two proteins in the blood appears to be suitable for ruling out significant intracranial injuries in patients with a history of mild traumatic brain injury (TBI) without the need for a CT head scan, according to data presented at the annual meeting of the American College of Emergency Physicians.

Ted Bosworth/MDedge News

A biomarker suitable for ruling out significant brain injury could save substantial resources because only about 10% of patients with mild TBI have a positive CT head scan, according to Jeffrey J. Bazarian, MD, professor of emergency medicine, University of Rochester (New York).

In the ALERT-TBI study, which evaluated the biomarker test, 1,959 patients with suspected TBI at 22 participating EDs in the United States and Europe were enrolled and available for analysis. All had mild TBI as defined as a Glasgow Coma Scale (GCS) score of 13-15.

The treating ED physician’s decision to order a head CT scan was the major criterion for study entry. All enrolled patients had their blood drawn within 12 hours in order to quantify two biomarkers, C-terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP).

The biomarker test for TBI was negative when the UCH-L1 value was less than 327 pg/mL and the GFAP was less than 22 pg/mL; the test was positive if either value was at this threshold or higher. To evaluate the sensitivity and specificity of this dual-biomarker test, results were correlated with head CT scans read by two neurologists blinded to the biomarker values.

The mean age of the study population was 48.8 years and slightly more than half were male. About half of the suspected TBI in these patients was attributed to falls and about one third to motor vehicle accidents.

Typical of TBI with GCS scores in the mild range, only 6% of the patients had a positive CT head scan. Of the 125 positive CT scans, the most common injury detected on CT scan was subarachnoid hemorrhage followed by subdural hematoma.

Of the 671 negative biomarker tests, 668 had normal head CT scans. Of the three false positives, one included a cavernous malformation that may have been present prior to the TBI. The others were a small subarachnoid hemorrhage and a small subdural hematoma. Overall the negative predictive value was 99.6% and the sensitivity was 97.6%.

Although the biomarker specificity was only 36% with an even-lower positive predictive value, the goal of the test was to rule out significant TBI to avoid the need for CT scan. On this basis, the biomarker test, which is being developed under the proprietary name Banyan BTI, appears to be promising. The data, according to Dr. Bazarian, have been submitted to the Food and Drug Administration.

“Head CT scans are the current standard for evaluating intracranial injuries after TBI, but they are overused, based on the high proportion that do not show an injury,” said Dr. Bazarian. Although he does not know the disposition of the FDA application, he said, based on these data, “I would definitely be using this test if it were available.”