BERLIN—Relapse-induced escalation to a highly effective disease-modifying therapy (DMT) is associated with a reduced risk of relapses, according to comprehensive nationwide data from Danish patients with multiple sclerosis (MS). Escalation is associated with a statistically nonsignificant trend toward reduced time to first one-point worsening of Expanded Disability Status Scale (EDSS) score over the short-to-medium term. “Escalation of therapy to a highly effective DMT when patients experience relapses on a moderately effective DMT is recommended to improve control of relapse activity,” said Thor Ameri Chalmer, MD, a doctoral student at Rigshospitalet in Copenhagen, and colleagues at ECTRIMS 2018.

Patients with relapsing-remitting MS who have relapses often switch to a new DMT. Treatment guidelines recommend switching to a highly effective DMT when a patient experiences clinical disease breakthrough. Nevertheless, patients may switch between moderately effective DMTs because of breakthrough disease or adverse effects. Dr. Chalmer and colleagues compared treatment effectiveness between highly effective DMTs and moderately effective DMTs in patients with relapsing-remitting MS who switch therapy because of relapse activity.

In this registry-based cohort study, the investigators retrieved data from the Danish MS Registry on all adults with relapsing-remitting MS. Eligible participants had an EDSS score below 6, experienced a relapse while treated with a moderately effective DMT, and consequently switched to a highly effective DMT or another moderately effective DMT. The groups were compared from treatment initiation until outcome or censoring. Censoring was defined as postbaseline switch between highly effective DMT and moderately effective DMT, cessation of therapy, relocation, or death, whichever occurred first. The primary outcomes were annualized relapse rate (ARR), relapse rate ratio, time to first relapse, and time to first one-point confirmed EDSS worsening. Dr. Chalmer and colleagues used propensity score matching to balance groups, a Cox proportional hazards model to obtain hazard ratios (HR) when modeling time to first relapse and time to first worsening, and negative binomial regression to obtain ARR and relapse rate ratios.

The matched cohort included 814 patients (407 in each group). The median follow-up time was 3.2 years. The group of patients who switched to a highly effective DMT had a 39% lower hazard rate of reaching first relapse (HR, 0.61). ARRs were 0.21 for patients who switched to a highly effective DMT and 0.34 for patients who switched to a moderately effective DMT. Relapse rate ratio for highly effective DMT compared with moderately effective DMT was 0.62. The group who switched to a highly effective DMT had 13% lower hazard rate of one-point EDSS worsening (HR, 0.87).

BERLIN—Relapse-induced escalation to a highly effective disease-modifying therapy (DMT) is associated with a reduced risk of relapses, according to comprehensive nationwide data from Danish patients with multiple sclerosis (MS). Escalation is associated with a statistically nonsignificant trend toward reduced time to first one-point worsening of Expanded Disability Status Scale (EDSS) score over the short-to-medium term. “Escalation of therapy to a highly effective DMT when patients experience relapses on a moderately effective DMT is recommended to improve control of relapse activity,” said Thor Ameri Chalmer, MD, a doctoral student at Rigshospitalet in Copenhagen, and colleagues at ECTRIMS 2018.

Patients with relapsing-remitting MS who have relapses often switch to a new DMT. Treatment guidelines recommend switching to a highly effective DMT when a patient experiences clinical disease breakthrough. Nevertheless, patients may switch between moderately effective DMTs because of breakthrough disease or adverse effects. Dr. Chalmer and colleagues compared treatment effectiveness between highly effective DMTs and moderately effective DMTs in patients with relapsing-remitting MS who switch therapy because of relapse activity.

In this registry-based cohort study, the investigators retrieved data from the Danish MS Registry on all adults with relapsing-remitting MS. Eligible participants had an EDSS score below 6, experienced a relapse while treated with a moderately effective DMT, and consequently switched to a highly effective DMT or another moderately effective DMT. The groups were compared from treatment initiation until outcome or censoring. Censoring was defined as postbaseline switch between highly effective DMT and moderately effective DMT, cessation of therapy, relocation, or death, whichever occurred first. The primary outcomes were annualized relapse rate (ARR), relapse rate ratio, time to first relapse, and time to first one-point confirmed EDSS worsening. Dr. Chalmer and colleagues used propensity score matching to balance groups, a Cox proportional hazards model to obtain hazard ratios (HR) when modeling time to first relapse and time to first worsening, and negative binomial regression to obtain ARR and relapse rate ratios.

The matched cohort included 814 patients (407 in each group). The median follow-up time was 3.2 years. The group of patients who switched to a highly effective DMT had a 39% lower hazard rate of reaching first relapse (HR, 0.61). ARRs were 0.21 for patients who switched to a highly effective DMT and 0.34 for patients who switched to a moderately effective DMT. Relapse rate ratio for highly effective DMT compared with moderately effective DMT was 0.62. The group who switched to a highly effective DMT had 13% lower hazard rate of one-point EDSS worsening (HR, 0.87).

BERLIN—Relapse-induced escalation to a highly effective disease-modifying therapy (DMT) is associated with a reduced risk of relapses, according to comprehensive nationwide data from Danish patients with multiple sclerosis (MS). Escalation is associated with a statistically nonsignificant trend toward reduced time to first one-point worsening of Expanded Disability Status Scale (EDSS) score over the short-to-medium term. “Escalation of therapy to a highly effective DMT when patients experience relapses on a moderately effective DMT is recommended to improve control of relapse activity,” said Thor Ameri Chalmer, MD, a doctoral student at Rigshospitalet in Copenhagen, and colleagues at ECTRIMS 2018.

Patients with relapsing-remitting MS who have relapses often switch to a new DMT. Treatment guidelines recommend switching to a highly effective DMT when a patient experiences clinical disease breakthrough. Nevertheless, patients may switch between moderately effective DMTs because of breakthrough disease or adverse effects. Dr. Chalmer and colleagues compared treatment effectiveness between highly effective DMTs and moderately effective DMTs in patients with relapsing-remitting MS who switch therapy because of relapse activity.

In this registry-based cohort study, the investigators retrieved data from the Danish MS Registry on all adults with relapsing-remitting MS. Eligible participants had an EDSS score below 6, experienced a relapse while treated with a moderately effective DMT, and consequently switched to a highly effective DMT or another moderately effective DMT. The groups were compared from treatment initiation until outcome or censoring. Censoring was defined as postbaseline switch between highly effective DMT and moderately effective DMT, cessation of therapy, relocation, or death, whichever occurred first. The primary outcomes were annualized relapse rate (ARR), relapse rate ratio, time to first relapse, and time to first one-point confirmed EDSS worsening. Dr. Chalmer and colleagues used propensity score matching to balance groups, a Cox proportional hazards model to obtain hazard ratios (HR) when modeling time to first relapse and time to first worsening, and negative binomial regression to obtain ARR and relapse rate ratios.

The matched cohort included 814 patients (407 in each group). The median follow-up time was 3.2 years. The group of patients who switched to a highly effective DMT had a 39% lower hazard rate of reaching first relapse (HR, 0.61). ARRs were 0.21 for patients who switched to a highly effective DMT and 0.34 for patients who switched to a moderately effective DMT. Relapse rate ratio for highly effective DMT compared with moderately effective DMT was 0.62. The group who switched to a highly effective DMT had 13% lower hazard rate of one-point EDSS worsening (HR, 0.87).

ASHEVILLE, NC—The 30 days after surgery are a period of exceptionally high risk for ischemic stroke, and the risk is greater for patients with migraine, compared with patients without migraine, according to a lecture at the Eighth Annual Scientific Meeting of the Southern Headache Society.

“When we send individuals with migraine to surgery who do not have classical risk factors [for stroke], they may, in fact, still be at risk for stroke during the perioperative period,” said Timothy T. Houle, PhD, Associate Professor of Anesthesia at Massachusetts General Hospital and Harvard Medical School in Boston.

Dr. Houle described a hospital-based registry study that he and his colleagues published in BMJ. They found that the rate of ischemic stroke within 30 days of surgery was about 240 strokes per 100,000 patients without migraine, whereas among migraineurs, the rate was 430 strokes per 100,000 patients. Among patients with migraine without aura, the rate was 390 strokes per 100,000 patients, and among patients with migraine with aura, the rate was 630 strokes per 100,000 patients. “If you have migraine with aura, your risk of having a stroke is appreciably elevated and not trivial,” Dr. Houle said. “This is something to take seriously.”

The Migraine–Stroke Connection

Researchers consistently have found that migraine is associated with an increased risk of ischemic stroke in the general population, but the relationship has been challenging to study.

Possible mechanisms underlying the relationship between migraine and stroke include comorbidities (eg, higher BMI and increased cardiovascular risk factors) and medication use. In addition, research suggests that cortical spreading depression might make migraineurs’ brains more susceptible to stroke, Dr. Houle said. Patent foramen ovale, arterial dissection, coagulation dysfunction, endothelial dysfunction, or a genotype that increases the risk of migraine and stroke are other potential pathways.

Spector et al conducted a meta-analysis of 21 studies and concluded that migraine appears to be independently associated with a twofold increased risk of ischemic stroke. A meta-analysis by Schürks et al found that the relative risk of stroke was about 1.73 for patients with migraine and 2.16 for patients with migraine with aura. Migraine without aura was associated with a relative risk of 1.23, but this result was not statistically significant.

Dr. Houle and colleagues hypothesized that focusing on the perioperative period, when stroke is more prevalent, “could yield unique insights into the migraine–stroke connection,” he said.

Ischemic stroke in the perioperative period occurs at a rate of about 100 strokes per 100,000 individuals for the lowest-risk surgeries. After major cardiac and vascular surgery, the risk may be between 600 and 7,400 strokes per 100,000 individuals. “We have … a risk period that is intensely elevated for patients about to receive surgical insult,” Dr. Houle said. The increased risk may result from the indication for the surgery, as well as factors related to surgery itself, such as surgical stress, inflammatory responses, and intraoperative hypotension.

A Retrospective Cohort Study

Based on the increased risk of stroke in the general population, the investigators hypothesized that individuals with migraine also would have an elevated risk of stroke in the 30 days after surgery. They analyzed data from 124,558 patients (mean age, 52.6; 54.5% women) who underwent surgery between 2007 and 2014 at Massachusetts General Hospital and two satellite campuses. They included patients who had surgery under general anesthesia with mechanical ventilation and were successfully extubated. They used ICD-9 codes to identify patients with migraine. The primary outcome was ischemic stroke within 30 days. They identified strokes using ICD-9 codes and confirmed strokes by reviewing brain scans and medical records.

The investigators adjusted for confounders, including sex, age, BMI, emergent versus nonemergent surgery, prescriptions of antiplatelet drugs or beta blockers within four weeks before surgery, minutes of intraoperative hypotension, diabetes, hypertension, atrial fibrillation, Charleston Comorbidity Index, and work relative value units (ie, a surrogate for surgical complexity).

The cohort included 10,179 individuals with migraine (8.2%). Of the patients with migraine, 12.6% had migraine with aura.

Patients with migraine generally were younger, had higher BMI, and were more likely to be women. They were less likely to have diabetes or hypertension and to be taking antiplatelet drugs or beta blockers. Patients with migraine “were a little healthier” than the patients without migraine, Dr. Houle said.

In all, 771 patients had perioperative stroke, of whom 89 (11.5%) had migraine. About 0.6% of patients without migraine had perioperative stroke versus 0.9% of patients with migraine. The unadjusted odds ratio for stroke among migraineurs was 1.47, and the adjusted odds ratio was 1.75. “Individuals in this sample who had any migraine were at greater risk for stroke during the period after surgery, just like in the regular population,” said Dr. Houle. Although migraine without aura was not a statistically significant risk factor for stroke in the general population, it was after surgery.

Prediction Models

In one sensitivity analysis, the researchers determined each patient’s stroke risk based on known risk factors excluding migraine, such as age and cardiovascular disorders, and grouped patients by low, intermediate, and high levels of risk. Among patients in the low-risk group, the relative risk of stroke for patients with migraine versus patients without migraine was 3.5-fold higher. “These are people you would not have identified as having risk,” said Dr. Houle.

Future studies should try to identify the mechanisms involved in this relationship and assess interventions to mitigate the risk of stroke in patients with migraine who undergo surgery, Dr. Houle said.

Dr. Houle and colleagues have created a stroke prediction model that includes migraine and will “give surgeons a risk model to predict the risk of stroke for their patients,” he said. The model will “realize the risks that we uncovered in this study.”

—Jake Remaly

Suggested Reading

Schürks M, Rist PM, Bigal ME, et al. Migraine and cardiovascular disease: systematic review and meta-analysis. BMJ. 2009;339:b3914.

Spector JT, Kahn SR, Jones MR, et al. Migraine headache and ischemic stroke risk: an updated meta-analysis. Am J Med. 2010;123(7):612-624.

Timm FP, Houle TT, Grabitz SD, et al. Migraine and risk of perioperative ischemic stroke and hospital readmission: hospital based registry study. BMJ. 2017;356:i6635.

ASHEVILLE, NC—The 30 days after surgery are a period of exceptionally high risk for ischemic stroke, and the risk is greater for patients with migraine, compared with patients without migraine, according to a lecture at the Eighth Annual Scientific Meeting of the Southern Headache Society.

“When we send individuals with migraine to surgery who do not have classical risk factors [for stroke], they may, in fact, still be at risk for stroke during the perioperative period,” said Timothy T. Houle, PhD, Associate Professor of Anesthesia at Massachusetts General Hospital and Harvard Medical School in Boston.

Dr. Houle described a hospital-based registry study that he and his colleagues published in BMJ. They found that the rate of ischemic stroke within 30 days of surgery was about 240 strokes per 100,000 patients without migraine, whereas among migraineurs, the rate was 430 strokes per 100,000 patients. Among patients with migraine without aura, the rate was 390 strokes per 100,000 patients, and among patients with migraine with aura, the rate was 630 strokes per 100,000 patients. “If you have migraine with aura, your risk of having a stroke is appreciably elevated and not trivial,” Dr. Houle said. “This is something to take seriously.”

The Migraine–Stroke Connection

Researchers consistently have found that migraine is associated with an increased risk of ischemic stroke in the general population, but the relationship has been challenging to study.

Possible mechanisms underlying the relationship between migraine and stroke include comorbidities (eg, higher BMI and increased cardiovascular risk factors) and medication use. In addition, research suggests that cortical spreading depression might make migraineurs’ brains more susceptible to stroke, Dr. Houle said. Patent foramen ovale, arterial dissection, coagulation dysfunction, endothelial dysfunction, or a genotype that increases the risk of migraine and stroke are other potential pathways.

Spector et al conducted a meta-analysis of 21 studies and concluded that migraine appears to be independently associated with a twofold increased risk of ischemic stroke. A meta-analysis by Schürks et al found that the relative risk of stroke was about 1.73 for patients with migraine and 2.16 for patients with migraine with aura. Migraine without aura was associated with a relative risk of 1.23, but this result was not statistically significant.

Dr. Houle and colleagues hypothesized that focusing on the perioperative period, when stroke is more prevalent, “could yield unique insights into the migraine–stroke connection,” he said.

Ischemic stroke in the perioperative period occurs at a rate of about 100 strokes per 100,000 individuals for the lowest-risk surgeries. After major cardiac and vascular surgery, the risk may be between 600 and 7,400 strokes per 100,000 individuals. “We have … a risk period that is intensely elevated for patients about to receive surgical insult,” Dr. Houle said. The increased risk may result from the indication for the surgery, as well as factors related to surgery itself, such as surgical stress, inflammatory responses, and intraoperative hypotension.

A Retrospective Cohort Study

Based on the increased risk of stroke in the general population, the investigators hypothesized that individuals with migraine also would have an elevated risk of stroke in the 30 days after surgery. They analyzed data from 124,558 patients (mean age, 52.6; 54.5% women) who underwent surgery between 2007 and 2014 at Massachusetts General Hospital and two satellite campuses. They included patients who had surgery under general anesthesia with mechanical ventilation and were successfully extubated. They used ICD-9 codes to identify patients with migraine. The primary outcome was ischemic stroke within 30 days. They identified strokes using ICD-9 codes and confirmed strokes by reviewing brain scans and medical records.

The investigators adjusted for confounders, including sex, age, BMI, emergent versus nonemergent surgery, prescriptions of antiplatelet drugs or beta blockers within four weeks before surgery, minutes of intraoperative hypotension, diabetes, hypertension, atrial fibrillation, Charleston Comorbidity Index, and work relative value units (ie, a surrogate for surgical complexity).

The cohort included 10,179 individuals with migraine (8.2%). Of the patients with migraine, 12.6% had migraine with aura.

Patients with migraine generally were younger, had higher BMI, and were more likely to be women. They were less likely to have diabetes or hypertension and to be taking antiplatelet drugs or beta blockers. Patients with migraine “were a little healthier” than the patients without migraine, Dr. Houle said.

In all, 771 patients had perioperative stroke, of whom 89 (11.5%) had migraine. About 0.6% of patients without migraine had perioperative stroke versus 0.9% of patients with migraine. The unadjusted odds ratio for stroke among migraineurs was 1.47, and the adjusted odds ratio was 1.75. “Individuals in this sample who had any migraine were at greater risk for stroke during the period after surgery, just like in the regular population,” said Dr. Houle. Although migraine without aura was not a statistically significant risk factor for stroke in the general population, it was after surgery.

Prediction Models

In one sensitivity analysis, the researchers determined each patient’s stroke risk based on known risk factors excluding migraine, such as age and cardiovascular disorders, and grouped patients by low, intermediate, and high levels of risk. Among patients in the low-risk group, the relative risk of stroke for patients with migraine versus patients without migraine was 3.5-fold higher. “These are people you would not have identified as having risk,” said Dr. Houle.

Future studies should try to identify the mechanisms involved in this relationship and assess interventions to mitigate the risk of stroke in patients with migraine who undergo surgery, Dr. Houle said.

Dr. Houle and colleagues have created a stroke prediction model that includes migraine and will “give surgeons a risk model to predict the risk of stroke for their patients,” he said. The model will “realize the risks that we uncovered in this study.”

—Jake Remaly

Suggested Reading

Schürks M, Rist PM, Bigal ME, et al. Migraine and cardiovascular disease: systematic review and meta-analysis. BMJ. 2009;339:b3914.

Spector JT, Kahn SR, Jones MR, et al. Migraine headache and ischemic stroke risk: an updated meta-analysis. Am J Med. 2010;123(7):612-624.

Timm FP, Houle TT, Grabitz SD, et al. Migraine and risk of perioperative ischemic stroke and hospital readmission: hospital based registry study. BMJ. 2017;356:i6635.

ASHEVILLE, NC—The 30 days after surgery are a period of exceptionally high risk for ischemic stroke, and the risk is greater for patients with migraine, compared with patients without migraine, according to a lecture at the Eighth Annual Scientific Meeting of the Southern Headache Society.

“When we send individuals with migraine to surgery who do not have classical risk factors [for stroke], they may, in fact, still be at risk for stroke during the perioperative period,” said Timothy T. Houle, PhD, Associate Professor of Anesthesia at Massachusetts General Hospital and Harvard Medical School in Boston.

Dr. Houle described a hospital-based registry study that he and his colleagues published in BMJ. They found that the rate of ischemic stroke within 30 days of surgery was about 240 strokes per 100,000 patients without migraine, whereas among migraineurs, the rate was 430 strokes per 100,000 patients. Among patients with migraine without aura, the rate was 390 strokes per 100,000 patients, and among patients with migraine with aura, the rate was 630 strokes per 100,000 patients. “If you have migraine with aura, your risk of having a stroke is appreciably elevated and not trivial,” Dr. Houle said. “This is something to take seriously.”

The Migraine–Stroke Connection

Researchers consistently have found that migraine is associated with an increased risk of ischemic stroke in the general population, but the relationship has been challenging to study.

Possible mechanisms underlying the relationship between migraine and stroke include comorbidities (eg, higher BMI and increased cardiovascular risk factors) and medication use. In addition, research suggests that cortical spreading depression might make migraineurs’ brains more susceptible to stroke, Dr. Houle said. Patent foramen ovale, arterial dissection, coagulation dysfunction, endothelial dysfunction, or a genotype that increases the risk of migraine and stroke are other potential pathways.

Spector et al conducted a meta-analysis of 21 studies and concluded that migraine appears to be independently associated with a twofold increased risk of ischemic stroke. A meta-analysis by Schürks et al found that the relative risk of stroke was about 1.73 for patients with migraine and 2.16 for patients with migraine with aura. Migraine without aura was associated with a relative risk of 1.23, but this result was not statistically significant.

Dr. Houle and colleagues hypothesized that focusing on the perioperative period, when stroke is more prevalent, “could yield unique insights into the migraine–stroke connection,” he said.

Ischemic stroke in the perioperative period occurs at a rate of about 100 strokes per 100,000 individuals for the lowest-risk surgeries. After major cardiac and vascular surgery, the risk may be between 600 and 7,400 strokes per 100,000 individuals. “We have … a risk period that is intensely elevated for patients about to receive surgical insult,” Dr. Houle said. The increased risk may result from the indication for the surgery, as well as factors related to surgery itself, such as surgical stress, inflammatory responses, and intraoperative hypotension.

A Retrospective Cohort Study

Based on the increased risk of stroke in the general population, the investigators hypothesized that individuals with migraine also would have an elevated risk of stroke in the 30 days after surgery. They analyzed data from 124,558 patients (mean age, 52.6; 54.5% women) who underwent surgery between 2007 and 2014 at Massachusetts General Hospital and two satellite campuses. They included patients who had surgery under general anesthesia with mechanical ventilation and were successfully extubated. They used ICD-9 codes to identify patients with migraine. The primary outcome was ischemic stroke within 30 days. They identified strokes using ICD-9 codes and confirmed strokes by reviewing brain scans and medical records.

The investigators adjusted for confounders, including sex, age, BMI, emergent versus nonemergent surgery, prescriptions of antiplatelet drugs or beta blockers within four weeks before surgery, minutes of intraoperative hypotension, diabetes, hypertension, atrial fibrillation, Charleston Comorbidity Index, and work relative value units (ie, a surrogate for surgical complexity).

The cohort included 10,179 individuals with migraine (8.2%). Of the patients with migraine, 12.6% had migraine with aura.

Patients with migraine generally were younger, had higher BMI, and were more likely to be women. They were less likely to have diabetes or hypertension and to be taking antiplatelet drugs or beta blockers. Patients with migraine “were a little healthier” than the patients without migraine, Dr. Houle said.

In all, 771 patients had perioperative stroke, of whom 89 (11.5%) had migraine. About 0.6% of patients without migraine had perioperative stroke versus 0.9% of patients with migraine. The unadjusted odds ratio for stroke among migraineurs was 1.47, and the adjusted odds ratio was 1.75. “Individuals in this sample who had any migraine were at greater risk for stroke during the period after surgery, just like in the regular population,” said Dr. Houle. Although migraine without aura was not a statistically significant risk factor for stroke in the general population, it was after surgery.

Prediction Models

In one sensitivity analysis, the researchers determined each patient’s stroke risk based on known risk factors excluding migraine, such as age and cardiovascular disorders, and grouped patients by low, intermediate, and high levels of risk. Among patients in the low-risk group, the relative risk of stroke for patients with migraine versus patients without migraine was 3.5-fold higher. “These are people you would not have identified as having risk,” said Dr. Houle.

Future studies should try to identify the mechanisms involved in this relationship and assess interventions to mitigate the risk of stroke in patients with migraine who undergo surgery, Dr. Houle said.

Dr. Houle and colleagues have created a stroke prediction model that includes migraine and will “give surgeons a risk model to predict the risk of stroke for their patients,” he said. The model will “realize the risks that we uncovered in this study.”

—Jake Remaly

Suggested Reading

Schürks M, Rist PM, Bigal ME, et al. Migraine and cardiovascular disease: systematic review and meta-analysis. BMJ. 2009;339:b3914.

Spector JT, Kahn SR, Jones MR, et al. Migraine headache and ischemic stroke risk: an updated meta-analysis. Am J Med. 2010;123(7):612-624.

Timm FP, Houle TT, Grabitz SD, et al. Migraine and risk of perioperative ischemic stroke and hospital readmission: hospital based registry study. BMJ. 2017;356:i6635.

CHICAGO—Home-based, parent-administered behavioral therapy supplemented by telephone contact with a therapist is effective in reducing complex motor stereotypies in children as young as 5, according to a study presented at the 47th Annual Meeting of the Child Neurology Society. “We recommend this combined approach for children ages 5 and older,” said Harvey S. Singer, MD, Professor of Neurology at Johns Hopkins School of Medicine in Baltimore, and colleagues.

Rhythmic Movements

Motor stereotypies are repetitive, rhythmic, fixed movements that last for seconds or minutes, stop with distraction, and are thought to arise from alterations within habitual motor pathways in the brain. Complex motor stereotypies typically involve the upper extremities (eg, hand flapping and finger wiggling) and begin in early childhood. Pharmacologic therapy has not been effective, but behavioral therapy has benefited patients, Dr. Singer and colleagues said. In one study of 54 children ages 7 to 14, home-based, parent-administered behavioral therapy using an instructional DVD significantly reduced stereotypies versus baseline.

To evaluate the effectiveness of a home-based, parent-provided therapy accompanied by scheduled telephone calls with a therapist in patients ages 5 to 7 with primary complex motor stereotypies, Dr. Singer and colleagues conducted a study with 38 children (24 boys; mean age, 6).

Patients had confirmed complex motor stereotypies with onset before age 3. Patients reported no premonitory urge and had temporary suspension of movement by an external stimulus or distraction. The researchers did not exclude patients due to inattentiveness, hyperactivity, impulsivity, or obsessive-compulsive behaviors. They did exclude patients with autism spectrum disorder, evidence of intellectual disability, seizures or a known neurologic disorder, or motor or vocal tics. Primary outcome measures included the Stereotypy Severity Scale (SSS) Motor and Impairment scores and the Stereotypy Linear Analog Scale (SLAS). Secondary outcomes included Patient Global Impression of Improvement (PGI-I).

Behavioral Therapy

The investigators sent participants a 44-minute instructional DVD about complex motor stereotypies with instructions provided by a behavioral psychologist. Parents were instructed to implement awareness training in the first week and to collect data and reinforce suppression starting in Week 2. Awareness training aims to make the child aware of his or her movements by using videos showing the activity and by the practice of voluntarily starting and stopping the movement.

Fourteen of the 38 participants were lost to follow-up (ie, they completed no post-DVD receipt assessments). The intent-to-treat group included 24 participants (15 boys) who completed at least one phone call with the study psychologist after receiving the DVD. There was no difference in stereotypy severity among those who were lost to follow-up and those in the intent-to-treat group. Those lost to follow-up had higher scores on ADHD ratings, however, which “suggests those with greater ADHD symptomatology at baseline were more likely to drop out,” the researchers said.

Compared with baseline measures, participants in the intent-to-treat group had significant reductions in SSS Motor and SSS Impairment scores at the last available assessment, and outcome measures progressively improved during the study. On the PGI-I, 56.5% of participants were very much or much improved, 30% were improved, and 13% reported no change.

All primary outcome measures significantly decreased. SSS Motor scores decreased by 23% as measured by telephone and 30% as measured online, SSS Impairment scores decreased by 31% measured by telephone and 32% measured online, and SLAS decreased by 54% as measured online. “The similarity between beneficial outcomes on the SSS Motor and SSS Impairment scales suggest a positive impact on both the movements themselves and their functional impact,” Dr. Singer and colleagues said.

CHICAGO—Home-based, parent-administered behavioral therapy supplemented by telephone contact with a therapist is effective in reducing complex motor stereotypies in children as young as 5, according to a study presented at the 47th Annual Meeting of the Child Neurology Society. “We recommend this combined approach for children ages 5 and older,” said Harvey S. Singer, MD, Professor of Neurology at Johns Hopkins School of Medicine in Baltimore, and colleagues.

Rhythmic Movements

Motor stereotypies are repetitive, rhythmic, fixed movements that last for seconds or minutes, stop with distraction, and are thought to arise from alterations within habitual motor pathways in the brain. Complex motor stereotypies typically involve the upper extremities (eg, hand flapping and finger wiggling) and begin in early childhood. Pharmacologic therapy has not been effective, but behavioral therapy has benefited patients, Dr. Singer and colleagues said. In one study of 54 children ages 7 to 14, home-based, parent-administered behavioral therapy using an instructional DVD significantly reduced stereotypies versus baseline.

To evaluate the effectiveness of a home-based, parent-provided therapy accompanied by scheduled telephone calls with a therapist in patients ages 5 to 7 with primary complex motor stereotypies, Dr. Singer and colleagues conducted a study with 38 children (24 boys; mean age, 6).

Patients had confirmed complex motor stereotypies with onset before age 3. Patients reported no premonitory urge and had temporary suspension of movement by an external stimulus or distraction. The researchers did not exclude patients due to inattentiveness, hyperactivity, impulsivity, or obsessive-compulsive behaviors. They did exclude patients with autism spectrum disorder, evidence of intellectual disability, seizures or a known neurologic disorder, or motor or vocal tics. Primary outcome measures included the Stereotypy Severity Scale (SSS) Motor and Impairment scores and the Stereotypy Linear Analog Scale (SLAS). Secondary outcomes included Patient Global Impression of Improvement (PGI-I).

Behavioral Therapy

The investigators sent participants a 44-minute instructional DVD about complex motor stereotypies with instructions provided by a behavioral psychologist. Parents were instructed to implement awareness training in the first week and to collect data and reinforce suppression starting in Week 2. Awareness training aims to make the child aware of his or her movements by using videos showing the activity and by the practice of voluntarily starting and stopping the movement.

Fourteen of the 38 participants were lost to follow-up (ie, they completed no post-DVD receipt assessments). The intent-to-treat group included 24 participants (15 boys) who completed at least one phone call with the study psychologist after receiving the DVD. There was no difference in stereotypy severity among those who were lost to follow-up and those in the intent-to-treat group. Those lost to follow-up had higher scores on ADHD ratings, however, which “suggests those with greater ADHD symptomatology at baseline were more likely to drop out,” the researchers said.

Compared with baseline measures, participants in the intent-to-treat group had significant reductions in SSS Motor and SSS Impairment scores at the last available assessment, and outcome measures progressively improved during the study. On the PGI-I, 56.5% of participants were very much or much improved, 30% were improved, and 13% reported no change.

All primary outcome measures significantly decreased. SSS Motor scores decreased by 23% as measured by telephone and 30% as measured online, SSS Impairment scores decreased by 31% measured by telephone and 32% measured online, and SLAS decreased by 54% as measured online. “The similarity between beneficial outcomes on the SSS Motor and SSS Impairment scales suggest a positive impact on both the movements themselves and their functional impact,” Dr. Singer and colleagues said.

CHICAGO—Home-based, parent-administered behavioral therapy supplemented by telephone contact with a therapist is effective in reducing complex motor stereotypies in children as young as 5, according to a study presented at the 47th Annual Meeting of the Child Neurology Society. “We recommend this combined approach for children ages 5 and older,” said Harvey S. Singer, MD, Professor of Neurology at Johns Hopkins School of Medicine in Baltimore, and colleagues.

Rhythmic Movements

Motor stereotypies are repetitive, rhythmic, fixed movements that last for seconds or minutes, stop with distraction, and are thought to arise from alterations within habitual motor pathways in the brain. Complex motor stereotypies typically involve the upper extremities (eg, hand flapping and finger wiggling) and begin in early childhood. Pharmacologic therapy has not been effective, but behavioral therapy has benefited patients, Dr. Singer and colleagues said. In one study of 54 children ages 7 to 14, home-based, parent-administered behavioral therapy using an instructional DVD significantly reduced stereotypies versus baseline.

To evaluate the effectiveness of a home-based, parent-provided therapy accompanied by scheduled telephone calls with a therapist in patients ages 5 to 7 with primary complex motor stereotypies, Dr. Singer and colleagues conducted a study with 38 children (24 boys; mean age, 6).

Patients had confirmed complex motor stereotypies with onset before age 3. Patients reported no premonitory urge and had temporary suspension of movement by an external stimulus or distraction. The researchers did not exclude patients due to inattentiveness, hyperactivity, impulsivity, or obsessive-compulsive behaviors. They did exclude patients with autism spectrum disorder, evidence of intellectual disability, seizures or a known neurologic disorder, or motor or vocal tics. Primary outcome measures included the Stereotypy Severity Scale (SSS) Motor and Impairment scores and the Stereotypy Linear Analog Scale (SLAS). Secondary outcomes included Patient Global Impression of Improvement (PGI-I).

Behavioral Therapy

The investigators sent participants a 44-minute instructional DVD about complex motor stereotypies with instructions provided by a behavioral psychologist. Parents were instructed to implement awareness training in the first week and to collect data and reinforce suppression starting in Week 2. Awareness training aims to make the child aware of his or her movements by using videos showing the activity and by the practice of voluntarily starting and stopping the movement.

Fourteen of the 38 participants were lost to follow-up (ie, they completed no post-DVD receipt assessments). The intent-to-treat group included 24 participants (15 boys) who completed at least one phone call with the study psychologist after receiving the DVD. There was no difference in stereotypy severity among those who were lost to follow-up and those in the intent-to-treat group. Those lost to follow-up had higher scores on ADHD ratings, however, which “suggests those with greater ADHD symptomatology at baseline were more likely to drop out,” the researchers said.

Compared with baseline measures, participants in the intent-to-treat group had significant reductions in SSS Motor and SSS Impairment scores at the last available assessment, and outcome measures progressively improved during the study. On the PGI-I, 56.5% of participants were very much or much improved, 30% were improved, and 13% reported no change.

All primary outcome measures significantly decreased. SSS Motor scores decreased by 23% as measured by telephone and 30% as measured online, SSS Impairment scores decreased by 31% measured by telephone and 32% measured online, and SLAS decreased by 54% as measured online. “The similarity between beneficial outcomes on the SSS Motor and SSS Impairment scales suggest a positive impact on both the movements themselves and their functional impact,” Dr. Singer and colleagues said.

ASHEVILLE, NC—Patients with intractable cluster headache present an urgent challenge to neurologists. The disorder is associated with “the worst pain you can experience,” and most patients have suicidal ideation, said Todd Rozen, MD, a neurologist at Mayo Clinic in Jacksonville, Florida. To help these patients, it is necessary to confirm the diagnosis, conduct proper evaluations for secondary mimics, and choose the most appropriate and effective treatments, he said at the Eighth Annual Scientific Meeting of the Southern Headache Society.

Making the Diagnosis

The current diagnostic criteria for cluster headache include severe unilateral orbital, supraorbital, or temporal pain that lasts for 15 minutes to 180 minutes when untreated. Patients may have conjunctival injection, lacrimation, rhinorrhea, or a sense of restlessness. Most patients have between one and three attacks per day, and the average attack lasts from 60 minutes to 75 minutes, said Dr. Rozen. Migrainous features such as photophobia, phonophobia, and nausea are common in cluster headache, but should not affect the diagnosis. If the duration and frequency of attacks are consistent with cluster headache, then that is the correct diagnosis, said Dr. Rozen.

Like migraine, cluster headache may be episodic or chronic. Episodic cluster headache is more likely to remit than chronic cluster headache, but the former may transition to the latter.

The European Headache Fed­er­ation has defined treatment-refractory cluster headache as cluster headache that fails to respond to more than three typical preventive medicines. Regardless of whether the disorder is episodic or chronic for a given patient, it may become intractable, said Dr. Rozen.

Reasons for Intractability

One potential reason for intractability is an incorrect diagnosis. Cluster headache is a trigeminal autonomic cephalalgia (TAC), and a person with a diagnosis of intractable cluster headache may in fact have a different TAC. The TACs form a spectrum, and a patient’s disorder may change from cluster headache to paroxysmal hemicrania, for example, said Dr. Rozen. “Always think of [attack] duration and frequency to make your diagnosis.”

Another potential reason for intractability is that the headache is secondary to a lesion. The secondary headache disorders often mimic the primary headache disorders, but do not respond to typical medications. The three most common causes of secondary cluster headache are secretory pituitary tumors, carotid dissections, and cavernous sinus lesions. “Every cluster patient … deserves a brain MRI with or without the pituitary cuts, an MR angiogram (both head and neck with dissection protocol), and pituitary hormones,” said Dr. Rozen.

Established and Emerging Acute Treatments

The most common acute treatments for cluster headache are sumatriptan injection or nasal spray and high-flow oxygen. Most patients respond to these treatments, but for those who do not, neurologists may consider options such as dihydroergotamine (DHE) injection, ergotamines, intranasal lidocaine, olanzapine, chlorpromazine suppository, and indomethacin suppository. Data from the US Cluster Headache Survey, however, indicate that less than 45% of patients respond to these treatments.

Most patients with cluster headache do not respond to oral acute medications because they have slow onsets of action. An exception is zolmitriptan, which is administered in a 10-mg dose, as opposed to the traditional 5-mg oral dose. Another acute nonmedicinal therapy is a suboccipital nerve block, which often terminates a headache within a minute, said Dr. Rozen.

In addition, new acute treatments for cluster headache have emerged. One is the delivery of oxygen by demand valve, which provides oxygen according to the user’s respiration rate and tidal volume. Unlike previous delivery methods, which deliver a small amount of ambient air, the demand valve delivers 100% pure oxygen. The demand valve also allows hyperventilation, which may be crucial for effective treatment, said Dr. Rozen. Several studies have suggested that demand-valve oxygen may be more effective than the typically prescribed continuous-flow oxygen administered through a nonrebreather face mask.

In 2017, the FDA cleared gamma­Core, a noninvasive vagus nerve stimulation (VNS) device, for the acute treatment of episodic cluster headache. Patients can use the device to deliver two-minute doses of stimulation through a conductive gel applied to the neck. The treatment may be considered for patients who have not responded to other acute medications, said Dr. Rozen.

In a study by Schoenen and colleagues, 67% of patients with chronic cluster headache who were treated with on-demand sphenopalatine ganglion stimulation achieved pain relief. In comparison, 7% of patients who received sham treatment achieved pain relief. Sphenopalatine ganglion stimulation is not approved in the United States, however.

Preventive Treatment Is Essential

“It is absolutely key to treat cluster headaches with preventives unless [the patients] have two- to three-week cycles [of attacks],” said Dr. Rozen. Verapamil, lithium, valproic acid, daily corticosteroids, topiramate, melatonin, and methylergonovine can be used for the prevention of cluster headache attacks. Daily corticosteroids are appropriate if the patient’s cycles last for two to three weeks, said Dr. Rozen. Topiramate appears to be more effective in women with cluster headache than men.

Until a patient has failed to respond to all of these preventive treatments, it may be inappropriate to describe his or her disorder as refractory, said Dr. Rozen. If a patient partially responds to one preventive therapy, another can be added. Combination therapy for cluster headache is common, and as many as three medications can be administered concomitantly, said Dr. Rozen. Unlike for other headache disorders, doses for cluster headache can be raised to high levels.

Data from the US Cluster Headache Survey, though, show that less than half of patients respond to preventive treatments. In addition, more than 70% of respondents had never received any preventive treatment, “which is quite scary for such a horrible disorder,” said Dr. Rozen.

Other Treatments May Be Effective

The literature provides a small amount of evidence to support additional treatments for cluster headache. Three studies have indicated a benefit of daily treatment with triptans, particularly frovatriptan, said Dr. Rozen. Data also support transdermal clonidine, indomethacin, and intranasal civamide. “Gabapentin is a wonderful add-on therapy. It is not good as a primary therapy,” said Dr. Rozen. Neurologists also may choose baclofen or mycophenolate mofetil.

Reports indicate that sodium oxybate can alleviate episodic and chronic cluster headache, especially if the patient has multiple nocturnal headaches, said Dr. Rozen. Three trials have examined hyperbaric oxygen, and a placebo-controlled trial found a benefit of warfarin. Rozen, and later Nobre et al, reported that clomiphene was effective and could change the pattern of cluster headache attacks.

Between 40% and 50% of patients respond to a single suboccipital nerve block as preventive therapy. Dr. Rozen has reported on high-volume suboccipital nerve blocks that administer 9 cm3 of 1% lidocaine and a small amount of corticosteroid. This treatment has “an excellent preventive effect in chronic refractory cluster headache,” he added. “Most of these patients have failed eight to 10 preventive [treatments]…. If you fail block one, you will most likely not respond to blocks.” Many patients who respond to this block could respond well to greater occipital nerve stimulation, but it is not easy to get insurance coverage for this treatment, said Dr. Rozen.

Finally, a new class of medications may be approved for cluster headache prevention. The monoclonal calcitonin gene-related peptide antibodies, which have been approved for migraine prevention, appear to be effective for episodic cluster headache in clinical trials. These treatments may not show efficacy for chronic cluster headache, however.

—Erik Greb

Suggested Reading

Cohen AS, Burns B, Goadsby PJ. High-flow oxygen for treatment of cluster headache: a randomized trial. JAMA. 2009;302(22):2451-2457.

Nobre ME, Peres MFP, Moreira PF Filho, Leal AJ. Clomiphene treatment may be effective in refractory episodic and chronic cluster headache. Arq Neuropsiquiatr. 2017;75(9):620-624.

Rozen TD, Fishman RS. Cluster headache in the United States of America: demographics, clinical characteristics, triggers, suicidality, and personal burden. Headache. 2012;52(1):99-113.

Rozen TD, Fishman RS. Demand valve oxygen: a promising new oxygen delivery system for the acute treatment of cluster headache. Pain Med. 2013;14(4):455-459.

Schoenen J, Jensen RH, Lantéri-Minet M, et al. Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: a randomized, sham-controlled study. Cephalalgia. 2013;33(10):816-830.

ASHEVILLE, NC—Patients with intractable cluster headache present an urgent challenge to neurologists. The disorder is associated with “the worst pain you can experience,” and most patients have suicidal ideation, said Todd Rozen, MD, a neurologist at Mayo Clinic in Jacksonville, Florida. To help these patients, it is necessary to confirm the diagnosis, conduct proper evaluations for secondary mimics, and choose the most appropriate and effective treatments, he said at the Eighth Annual Scientific Meeting of the Southern Headache Society.

Making the Diagnosis

The current diagnostic criteria for cluster headache include severe unilateral orbital, supraorbital, or temporal pain that lasts for 15 minutes to 180 minutes when untreated. Patients may have conjunctival injection, lacrimation, rhinorrhea, or a sense of restlessness. Most patients have between one and three attacks per day, and the average attack lasts from 60 minutes to 75 minutes, said Dr. Rozen. Migrainous features such as photophobia, phonophobia, and nausea are common in cluster headache, but should not affect the diagnosis. If the duration and frequency of attacks are consistent with cluster headache, then that is the correct diagnosis, said Dr. Rozen.

Like migraine, cluster headache may be episodic or chronic. Episodic cluster headache is more likely to remit than chronic cluster headache, but the former may transition to the latter.

The European Headache Fed­er­ation has defined treatment-refractory cluster headache as cluster headache that fails to respond to more than three typical preventive medicines. Regardless of whether the disorder is episodic or chronic for a given patient, it may become intractable, said Dr. Rozen.

Reasons for Intractability

One potential reason for intractability is an incorrect diagnosis. Cluster headache is a trigeminal autonomic cephalalgia (TAC), and a person with a diagnosis of intractable cluster headache may in fact have a different TAC. The TACs form a spectrum, and a patient’s disorder may change from cluster headache to paroxysmal hemicrania, for example, said Dr. Rozen. “Always think of [attack] duration and frequency to make your diagnosis.”

Another potential reason for intractability is that the headache is secondary to a lesion. The secondary headache disorders often mimic the primary headache disorders, but do not respond to typical medications. The three most common causes of secondary cluster headache are secretory pituitary tumors, carotid dissections, and cavernous sinus lesions. “Every cluster patient … deserves a brain MRI with or without the pituitary cuts, an MR angiogram (both head and neck with dissection protocol), and pituitary hormones,” said Dr. Rozen.

Established and Emerging Acute Treatments

The most common acute treatments for cluster headache are sumatriptan injection or nasal spray and high-flow oxygen. Most patients respond to these treatments, but for those who do not, neurologists may consider options such as dihydroergotamine (DHE) injection, ergotamines, intranasal lidocaine, olanzapine, chlorpromazine suppository, and indomethacin suppository. Data from the US Cluster Headache Survey, however, indicate that less than 45% of patients respond to these treatments.

Most patients with cluster headache do not respond to oral acute medications because they have slow onsets of action. An exception is zolmitriptan, which is administered in a 10-mg dose, as opposed to the traditional 5-mg oral dose. Another acute nonmedicinal therapy is a suboccipital nerve block, which often terminates a headache within a minute, said Dr. Rozen.

In addition, new acute treatments for cluster headache have emerged. One is the delivery of oxygen by demand valve, which provides oxygen according to the user’s respiration rate and tidal volume. Unlike previous delivery methods, which deliver a small amount of ambient air, the demand valve delivers 100% pure oxygen. The demand valve also allows hyperventilation, which may be crucial for effective treatment, said Dr. Rozen. Several studies have suggested that demand-valve oxygen may be more effective than the typically prescribed continuous-flow oxygen administered through a nonrebreather face mask.

In 2017, the FDA cleared gamma­Core, a noninvasive vagus nerve stimulation (VNS) device, for the acute treatment of episodic cluster headache. Patients can use the device to deliver two-minute doses of stimulation through a conductive gel applied to the neck. The treatment may be considered for patients who have not responded to other acute medications, said Dr. Rozen.

In a study by Schoenen and colleagues, 67% of patients with chronic cluster headache who were treated with on-demand sphenopalatine ganglion stimulation achieved pain relief. In comparison, 7% of patients who received sham treatment achieved pain relief. Sphenopalatine ganglion stimulation is not approved in the United States, however.

Preventive Treatment Is Essential

“It is absolutely key to treat cluster headaches with preventives unless [the patients] have two- to three-week cycles [of attacks],” said Dr. Rozen. Verapamil, lithium, valproic acid, daily corticosteroids, topiramate, melatonin, and methylergonovine can be used for the prevention of cluster headache attacks. Daily corticosteroids are appropriate if the patient’s cycles last for two to three weeks, said Dr. Rozen. Topiramate appears to be more effective in women with cluster headache than men.

Until a patient has failed to respond to all of these preventive treatments, it may be inappropriate to describe his or her disorder as refractory, said Dr. Rozen. If a patient partially responds to one preventive therapy, another can be added. Combination therapy for cluster headache is common, and as many as three medications can be administered concomitantly, said Dr. Rozen. Unlike for other headache disorders, doses for cluster headache can be raised to high levels.

Data from the US Cluster Headache Survey, though, show that less than half of patients respond to preventive treatments. In addition, more than 70% of respondents had never received any preventive treatment, “which is quite scary for such a horrible disorder,” said Dr. Rozen.

Other Treatments May Be Effective

The literature provides a small amount of evidence to support additional treatments for cluster headache. Three studies have indicated a benefit of daily treatment with triptans, particularly frovatriptan, said Dr. Rozen. Data also support transdermal clonidine, indomethacin, and intranasal civamide. “Gabapentin is a wonderful add-on therapy. It is not good as a primary therapy,” said Dr. Rozen. Neurologists also may choose baclofen or mycophenolate mofetil.

Reports indicate that sodium oxybate can alleviate episodic and chronic cluster headache, especially if the patient has multiple nocturnal headaches, said Dr. Rozen. Three trials have examined hyperbaric oxygen, and a placebo-controlled trial found a benefit of warfarin. Rozen, and later Nobre et al, reported that clomiphene was effective and could change the pattern of cluster headache attacks.

Between 40% and 50% of patients respond to a single suboccipital nerve block as preventive therapy. Dr. Rozen has reported on high-volume suboccipital nerve blocks that administer 9 cm3 of 1% lidocaine and a small amount of corticosteroid. This treatment has “an excellent preventive effect in chronic refractory cluster headache,” he added. “Most of these patients have failed eight to 10 preventive [treatments]…. If you fail block one, you will most likely not respond to blocks.” Many patients who respond to this block could respond well to greater occipital nerve stimulation, but it is not easy to get insurance coverage for this treatment, said Dr. Rozen.

Finally, a new class of medications may be approved for cluster headache prevention. The monoclonal calcitonin gene-related peptide antibodies, which have been approved for migraine prevention, appear to be effective for episodic cluster headache in clinical trials. These treatments may not show efficacy for chronic cluster headache, however.

—Erik Greb

Suggested Reading

Cohen AS, Burns B, Goadsby PJ. High-flow oxygen for treatment of cluster headache: a randomized trial. JAMA. 2009;302(22):2451-2457.

Nobre ME, Peres MFP, Moreira PF Filho, Leal AJ. Clomiphene treatment may be effective in refractory episodic and chronic cluster headache. Arq Neuropsiquiatr. 2017;75(9):620-624.

Rozen TD, Fishman RS. Cluster headache in the United States of America: demographics, clinical characteristics, triggers, suicidality, and personal burden. Headache. 2012;52(1):99-113.

Rozen TD, Fishman RS. Demand valve oxygen: a promising new oxygen delivery system for the acute treatment of cluster headache. Pain Med. 2013;14(4):455-459.

Schoenen J, Jensen RH, Lantéri-Minet M, et al. Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: a randomized, sham-controlled study. Cephalalgia. 2013;33(10):816-830.

ASHEVILLE, NC—Patients with intractable cluster headache present an urgent challenge to neurologists. The disorder is associated with “the worst pain you can experience,” and most patients have suicidal ideation, said Todd Rozen, MD, a neurologist at Mayo Clinic in Jacksonville, Florida. To help these patients, it is necessary to confirm the diagnosis, conduct proper evaluations for secondary mimics, and choose the most appropriate and effective treatments, he said at the Eighth Annual Scientific Meeting of the Southern Headache Society.

Making the Diagnosis

The current diagnostic criteria for cluster headache include severe unilateral orbital, supraorbital, or temporal pain that lasts for 15 minutes to 180 minutes when untreated. Patients may have conjunctival injection, lacrimation, rhinorrhea, or a sense of restlessness. Most patients have between one and three attacks per day, and the average attack lasts from 60 minutes to 75 minutes, said Dr. Rozen. Migrainous features such as photophobia, phonophobia, and nausea are common in cluster headache, but should not affect the diagnosis. If the duration and frequency of attacks are consistent with cluster headache, then that is the correct diagnosis, said Dr. Rozen.

Like migraine, cluster headache may be episodic or chronic. Episodic cluster headache is more likely to remit than chronic cluster headache, but the former may transition to the latter.

The European Headache Fed­er­ation has defined treatment-refractory cluster headache as cluster headache that fails to respond to more than three typical preventive medicines. Regardless of whether the disorder is episodic or chronic for a given patient, it may become intractable, said Dr. Rozen.

Reasons for Intractability

One potential reason for intractability is an incorrect diagnosis. Cluster headache is a trigeminal autonomic cephalalgia (TAC), and a person with a diagnosis of intractable cluster headache may in fact have a different TAC. The TACs form a spectrum, and a patient’s disorder may change from cluster headache to paroxysmal hemicrania, for example, said Dr. Rozen. “Always think of [attack] duration and frequency to make your diagnosis.”

Another potential reason for intractability is that the headache is secondary to a lesion. The secondary headache disorders often mimic the primary headache disorders, but do not respond to typical medications. The three most common causes of secondary cluster headache are secretory pituitary tumors, carotid dissections, and cavernous sinus lesions. “Every cluster patient … deserves a brain MRI with or without the pituitary cuts, an MR angiogram (both head and neck with dissection protocol), and pituitary hormones,” said Dr. Rozen.

Established and Emerging Acute Treatments

The most common acute treatments for cluster headache are sumatriptan injection or nasal spray and high-flow oxygen. Most patients respond to these treatments, but for those who do not, neurologists may consider options such as dihydroergotamine (DHE) injection, ergotamines, intranasal lidocaine, olanzapine, chlorpromazine suppository, and indomethacin suppository. Data from the US Cluster Headache Survey, however, indicate that less than 45% of patients respond to these treatments.

Most patients with cluster headache do not respond to oral acute medications because they have slow onsets of action. An exception is zolmitriptan, which is administered in a 10-mg dose, as opposed to the traditional 5-mg oral dose. Another acute nonmedicinal therapy is a suboccipital nerve block, which often terminates a headache within a minute, said Dr. Rozen.

In addition, new acute treatments for cluster headache have emerged. One is the delivery of oxygen by demand valve, which provides oxygen according to the user’s respiration rate and tidal volume. Unlike previous delivery methods, which deliver a small amount of ambient air, the demand valve delivers 100% pure oxygen. The demand valve also allows hyperventilation, which may be crucial for effective treatment, said Dr. Rozen. Several studies have suggested that demand-valve oxygen may be more effective than the typically prescribed continuous-flow oxygen administered through a nonrebreather face mask.

In 2017, the FDA cleared gamma­Core, a noninvasive vagus nerve stimulation (VNS) device, for the acute treatment of episodic cluster headache. Patients can use the device to deliver two-minute doses of stimulation through a conductive gel applied to the neck. The treatment may be considered for patients who have not responded to other acute medications, said Dr. Rozen.

In a study by Schoenen and colleagues, 67% of patients with chronic cluster headache who were treated with on-demand sphenopalatine ganglion stimulation achieved pain relief. In comparison, 7% of patients who received sham treatment achieved pain relief. Sphenopalatine ganglion stimulation is not approved in the United States, however.

Preventive Treatment Is Essential

“It is absolutely key to treat cluster headaches with preventives unless [the patients] have two- to three-week cycles [of attacks],” said Dr. Rozen. Verapamil, lithium, valproic acid, daily corticosteroids, topiramate, melatonin, and methylergonovine can be used for the prevention of cluster headache attacks. Daily corticosteroids are appropriate if the patient’s cycles last for two to three weeks, said Dr. Rozen. Topiramate appears to be more effective in women with cluster headache than men.

Until a patient has failed to respond to all of these preventive treatments, it may be inappropriate to describe his or her disorder as refractory, said Dr. Rozen. If a patient partially responds to one preventive therapy, another can be added. Combination therapy for cluster headache is common, and as many as three medications can be administered concomitantly, said Dr. Rozen. Unlike for other headache disorders, doses for cluster headache can be raised to high levels.

Data from the US Cluster Headache Survey, though, show that less than half of patients respond to preventive treatments. In addition, more than 70% of respondents had never received any preventive treatment, “which is quite scary for such a horrible disorder,” said Dr. Rozen.

Other Treatments May Be Effective

The literature provides a small amount of evidence to support additional treatments for cluster headache. Three studies have indicated a benefit of daily treatment with triptans, particularly frovatriptan, said Dr. Rozen. Data also support transdermal clonidine, indomethacin, and intranasal civamide. “Gabapentin is a wonderful add-on therapy. It is not good as a primary therapy,” said Dr. Rozen. Neurologists also may choose baclofen or mycophenolate mofetil.

Reports indicate that sodium oxybate can alleviate episodic and chronic cluster headache, especially if the patient has multiple nocturnal headaches, said Dr. Rozen. Three trials have examined hyperbaric oxygen, and a placebo-controlled trial found a benefit of warfarin. Rozen, and later Nobre et al, reported that clomiphene was effective and could change the pattern of cluster headache attacks.

Between 40% and 50% of patients respond to a single suboccipital nerve block as preventive therapy. Dr. Rozen has reported on high-volume suboccipital nerve blocks that administer 9 cm3 of 1% lidocaine and a small amount of corticosteroid. This treatment has “an excellent preventive effect in chronic refractory cluster headache,” he added. “Most of these patients have failed eight to 10 preventive [treatments]…. If you fail block one, you will most likely not respond to blocks.” Many patients who respond to this block could respond well to greater occipital nerve stimulation, but it is not easy to get insurance coverage for this treatment, said Dr. Rozen.

Finally, a new class of medications may be approved for cluster headache prevention. The monoclonal calcitonin gene-related peptide antibodies, which have been approved for migraine prevention, appear to be effective for episodic cluster headache in clinical trials. These treatments may not show efficacy for chronic cluster headache, however.

—Erik Greb

Suggested Reading

Cohen AS, Burns B, Goadsby PJ. High-flow oxygen for treatment of cluster headache: a randomized trial. JAMA. 2009;302(22):2451-2457.

Nobre ME, Peres MFP, Moreira PF Filho, Leal AJ. Clomiphene treatment may be effective in refractory episodic and chronic cluster headache. Arq Neuropsiquiatr. 2017;75(9):620-624.

Rozen TD, Fishman RS. Cluster headache in the United States of America: demographics, clinical characteristics, triggers, suicidality, and personal burden. Headache. 2012;52(1):99-113.

Rozen TD, Fishman RS. Demand valve oxygen: a promising new oxygen delivery system for the acute treatment of cluster headache. Pain Med. 2013;14(4):455-459.

Schoenen J, Jensen RH, Lantéri-Minet M, et al. Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: a randomized, sham-controlled study. Cephalalgia. 2013;33(10):816-830.

CHICAGO – Discontinuing methotrexate for 2 weeks in patients with RA starting the day they receive the seasonal influenza vaccine significantly improves the vaccine’s immunogenicity without aggravating disease activity, Kevin L. Winthrop, MD, reported at the annual meeting of the American College of Rheumatology.

Bruce Jancin/MDedge News

“I think this is potentially clinically practice changing because now there are two studies showing the same thing,” said Dr. Winthrop, a professor of public health and preventive medicine at Oregon Health & Science University, Portland.

Based upon these prospective randomized studies, which he conducted together with investigators at Seoul National University in South Korea, initiating a 2-week halt of methotrexate on the day the influenza vaccine is given to patients with RA is now his routine practice, and he recommends other physicians do the same.


The first prospective, randomized trial included 199 RA patients on stable doses of methotrexate who were assigned to one of four groups in conjunction with seasonal influenza vaccination. One group continued their methotrexate as usual, the second stopped the drug for 1 month prior to vaccination and then restarted it at the time of vaccination, the third group halted methotrexate for 2 weeks before and 2 weeks after vaccination, and the fourth suspended methotrexate for 4 weeks starting on the day they got their flu shot. Everyone received trivalent influenza vaccine containing H1N1, H3N2, and B/Yamagata.

The lowest rate of satisfactory vaccine response as defined by at least a 300% titer increase 1 month after vaccination occurred in the group that continued their methotrexate as usual. The group that halted the drug for 2 weeks before and 2 weeks after influenza vaccination had a 51% satisfactory vaccine response against all three antigens, compared with a 31.5% rate in the methotrexate-as-usual group. RA flare rates ranged from 21% to 39% across the four study arms, differences that weren’t statistically significant (Ann Rheum Dis. 2017 Sep;76[9]:1559-65).

Next Dr. Winthrop and his colleagues conducted a confirmatory prospective, multicenter, randomized trial in which they sought to nail down the optimal duration and timing of methotrexate discontinuation. A total of 320 RA patients on stable doses of methotrexate were assigned to halt the drug for 2 weeks starting at the time they received a quadrivalent seasonal influenza vaccine containing H1N1, H3N2, B/Yamagata, and B/Victoria strains, or to continue their methotrexate throughout.

A satisfactory vaccine response was achieved in 75.5% of the group that discontinued the drug, significantly better than the 54.5% rate in the methotrexate continuers. The absolute difference in seroprotection was greater in patients who halted their methotrexate for 2 weeks after vaccination for all four antigens: an absolute 11% difference for H1N1, 16% for H3N2, 12% for B/Yamagata, and 15% for B/Victoria (Ann Rheum Dis. 2018 Jun;77[6]:898-904).

“It does seem to be a nice strategy. The percentage of people who flared their RA during their 2 weeks off methotrexate was very low, so there seems to be a good reason to do this,” according to Dr. Winthrop.


Some rheumatologists he has spoken with initially balked at the plausibility of the results.

“I had the same thought about these studies: It doesn’t make sense to me in terms of how methotrexate works, and why we would see this effect acutely by stopping methotrexate for just 2 weeks?” he said.

But then a coinvestigator drilled down deeper into the data and came up with the explanation: The benefit in terms of enhanced flu vaccine immunogenicity through temporary withholding of methotrexate was confined to the subgroup of RA patients with high baseline levels of B-cell activation factor (BAFF). In contrast, withholding methotrexate didn’t affect the vaccine response in patients with low or normal baseline BAFF (Ann Rheum Dis. 2018 Oct 8. doi: 10.1136/annrheumdis-2018-214025).

“I don’t know how to check anyone’s BAFF levels. I don’t think there’s a commercial test out there. But this does help explain why we saw this observation. So I think I would still hold everyone’s methotrexate for 2 weeks. That’s how I approach it. And they may get benefit from it, and they may not,” he said.

Dr. Winthrop reported having no financial conflicts regarding the study, which was funded by GC Pharma.

[email protected]

CHICAGO – Discontinuing methotrexate for 2 weeks in patients with RA starting the day they receive the seasonal influenza vaccine significantly improves the vaccine’s immunogenicity without aggravating disease activity, Kevin L. Winthrop, MD, reported at the annual meeting of the American College of Rheumatology.

Bruce Jancin/MDedge News

“I think this is potentially clinically practice changing because now there are two studies showing the same thing,” said Dr. Winthrop, a professor of public health and preventive medicine at Oregon Health & Science University, Portland.

Based upon these prospective randomized studies, which he conducted together with investigators at Seoul National University in South Korea, initiating a 2-week halt of methotrexate on the day the influenza vaccine is given to patients with RA is now his routine practice, and he recommends other physicians do the same.


The first prospective, randomized trial included 199 RA patients on stable doses of methotrexate who were assigned to one of four groups in conjunction with seasonal influenza vaccination. One group continued their methotrexate as usual, the second stopped the drug for 1 month prior to vaccination and then restarted it at the time of vaccination, the third group halted methotrexate for 2 weeks before and 2 weeks after vaccination, and the fourth suspended methotrexate for 4 weeks starting on the day they got their flu shot. Everyone received trivalent influenza vaccine containing H1N1, H3N2, and B/Yamagata.

The lowest rate of satisfactory vaccine response as defined by at least a 300% titer increase 1 month after vaccination occurred in the group that continued their methotrexate as usual. The group that halted the drug for 2 weeks before and 2 weeks after influenza vaccination had a 51% satisfactory vaccine response against all three antigens, compared with a 31.5% rate in the methotrexate-as-usual group. RA flare rates ranged from 21% to 39% across the four study arms, differences that weren’t statistically significant (Ann Rheum Dis. 2017 Sep;76[9]:1559-65).

Next Dr. Winthrop and his colleagues conducted a confirmatory prospective, multicenter, randomized trial in which they sought to nail down the optimal duration and timing of methotrexate discontinuation. A total of 320 RA patients on stable doses of methotrexate were assigned to halt the drug for 2 weeks starting at the time they received a quadrivalent seasonal influenza vaccine containing H1N1, H3N2, B/Yamagata, and B/Victoria strains, or to continue their methotrexate throughout.

A satisfactory vaccine response was achieved in 75.5% of the group that discontinued the drug, significantly better than the 54.5% rate in the methotrexate continuers. The absolute difference in seroprotection was greater in patients who halted their methotrexate for 2 weeks after vaccination for all four antigens: an absolute 11% difference for H1N1, 16% for H3N2, 12% for B/Yamagata, and 15% for B/Victoria (Ann Rheum Dis. 2018 Jun;77[6]:898-904).

“It does seem to be a nice strategy. The percentage of people who flared their RA during their 2 weeks off methotrexate was very low, so there seems to be a good reason to do this,” according to Dr. Winthrop.


Some rheumatologists he has spoken with initially balked at the plausibility of the results.

“I had the same thought about these studies: It doesn’t make sense to me in terms of how methotrexate works, and why we would see this effect acutely by stopping methotrexate for just 2 weeks?” he said.

But then a coinvestigator drilled down deeper into the data and came up with the explanation: The benefit in terms of enhanced flu vaccine immunogenicity through temporary withholding of methotrexate was confined to the subgroup of RA patients with high baseline levels of B-cell activation factor (BAFF). In contrast, withholding methotrexate didn’t affect the vaccine response in patients with low or normal baseline BAFF (Ann Rheum Dis. 2018 Oct 8. doi: 10.1136/annrheumdis-2018-214025).

“I don’t know how to check anyone’s BAFF levels. I don’t think there’s a commercial test out there. But this does help explain why we saw this observation. So I think I would still hold everyone’s methotrexate for 2 weeks. That’s how I approach it. And they may get benefit from it, and they may not,” he said.

Dr. Winthrop reported having no financial conflicts regarding the study, which was funded by GC Pharma.

[email protected]

CHICAGO – Discontinuing methotrexate for 2 weeks in patients with RA starting the day they receive the seasonal influenza vaccine significantly improves the vaccine’s immunogenicity without aggravating disease activity, Kevin L. Winthrop, MD, reported at the annual meeting of the American College of Rheumatology.

Bruce Jancin/MDedge News

“I think this is potentially clinically practice changing because now there are two studies showing the same thing,” said Dr. Winthrop, a professor of public health and preventive medicine at Oregon Health & Science University, Portland.

Based upon these prospective randomized studies, which he conducted together with investigators at Seoul National University in South Korea, initiating a 2-week halt of methotrexate on the day the influenza vaccine is given to patients with RA is now his routine practice, and he recommends other physicians do the same.


The first prospective, randomized trial included 199 RA patients on stable doses of methotrexate who were assigned to one of four groups in conjunction with seasonal influenza vaccination. One group continued their methotrexate as usual, the second stopped the drug for 1 month prior to vaccination and then restarted it at the time of vaccination, the third group halted methotrexate for 2 weeks before and 2 weeks after vaccination, and the fourth suspended methotrexate for 4 weeks starting on the day they got their flu shot. Everyone received trivalent influenza vaccine containing H1N1, H3N2, and B/Yamagata.

The lowest rate of satisfactory vaccine response as defined by at least a 300% titer increase 1 month after vaccination occurred in the group that continued their methotrexate as usual. The group that halted the drug for 2 weeks before and 2 weeks after influenza vaccination had a 51% satisfactory vaccine response against all three antigens, compared with a 31.5% rate in the methotrexate-as-usual group. RA flare rates ranged from 21% to 39% across the four study arms, differences that weren’t statistically significant (Ann Rheum Dis. 2017 Sep;76[9]:1559-65).

Next Dr. Winthrop and his colleagues conducted a confirmatory prospective, multicenter, randomized trial in which they sought to nail down the optimal duration and timing of methotrexate discontinuation. A total of 320 RA patients on stable doses of methotrexate were assigned to halt the drug for 2 weeks starting at the time they received a quadrivalent seasonal influenza vaccine containing H1N1, H3N2, B/Yamagata, and B/Victoria strains, or to continue their methotrexate throughout.

A satisfactory vaccine response was achieved in 75.5% of the group that discontinued the drug, significantly better than the 54.5% rate in the methotrexate continuers. The absolute difference in seroprotection was greater in patients who halted their methotrexate for 2 weeks after vaccination for all four antigens: an absolute 11% difference for H1N1, 16% for H3N2, 12% for B/Yamagata, and 15% for B/Victoria (Ann Rheum Dis. 2018 Jun;77[6]:898-904).

“It does seem to be a nice strategy. The percentage of people who flared their RA during their 2 weeks off methotrexate was very low, so there seems to be a good reason to do this,” according to Dr. Winthrop.


Some rheumatologists he has spoken with initially balked at the plausibility of the results.

“I had the same thought about these studies: It doesn’t make sense to me in terms of how methotrexate works, and why we would see this effect acutely by stopping methotrexate for just 2 weeks?” he said.

But then a coinvestigator drilled down deeper into the data and came up with the explanation: The benefit in terms of enhanced flu vaccine immunogenicity through temporary withholding of methotrexate was confined to the subgroup of RA patients with high baseline levels of B-cell activation factor (BAFF). In contrast, withholding methotrexate didn’t affect the vaccine response in patients with low or normal baseline BAFF (Ann Rheum Dis. 2018 Oct 8. doi: 10.1136/annrheumdis-2018-214025).

“I don’t know how to check anyone’s BAFF levels. I don’t think there’s a commercial test out there. But this does help explain why we saw this observation. So I think I would still hold everyone’s methotrexate for 2 weeks. That’s how I approach it. And they may get benefit from it, and they may not,” he said.

Dr. Winthrop reported having no financial conflicts regarding the study, which was funded by GC Pharma.

[email protected]

The Food and Drug Administration has approved elotuzumab (Empliciti) in combination with pomalidomide and dexamethasone for adults with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

Elotuzumab is already approved in combination with lenalidomide and dexamethasone to treat adult myeloma patients who have received one to three prior therapies.

The FDA’s latest approval of elotuzumab is based on results from ELOQUENT-3. This phase 2 trial enrolled multiple myeloma patients who had refractory or relapsed disease and had received both lenalidomide and a proteasome inhibitor.

In the trial, patients were randomized to receive elotuzumab plus pomalidomide and dexamethasone (EPd, n = 60) or pomalidomide and dexamethasone (Pd, n = 57) in 28-day cycles until disease progression or unacceptable toxicity.

The overall response rate was 53.3% in the EPd arm and 26.3% in the Pd arm (P = .0029); the rate of complete response or stringent complete response was 8.3% and 1.8%, respectively.


Median progression-free survival was 10.25 months with EPd and 4.67 months with Pd (P = .0078).

Serious adverse events occurred in 22% of patients in the EPd arm and 15% in the Pd arm. The most frequent serious adverse events were pneumonia and respiratory tract infection.

Additional results from ELOQUENT-3 can be found in the full prescribing information for elotuzumab, which is available on the Empliciti website.

Bristol-Myers Squibb and AbbVie are codeveloping elotuzumab, with Bristol-Myers Squibb solely responsible for commercial activities.

[email protected]

The Food and Drug Administration has approved elotuzumab (Empliciti) in combination with pomalidomide and dexamethasone for adults with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

Elotuzumab is already approved in combination with lenalidomide and dexamethasone to treat adult myeloma patients who have received one to three prior therapies.

The FDA’s latest approval of elotuzumab is based on results from ELOQUENT-3. This phase 2 trial enrolled multiple myeloma patients who had refractory or relapsed disease and had received both lenalidomide and a proteasome inhibitor.

In the trial, patients were randomized to receive elotuzumab plus pomalidomide and dexamethasone (EPd, n = 60) or pomalidomide and dexamethasone (Pd, n = 57) in 28-day cycles until disease progression or unacceptable toxicity.

The overall response rate was 53.3% in the EPd arm and 26.3% in the Pd arm (P = .0029); the rate of complete response or stringent complete response was 8.3% and 1.8%, respectively.


Median progression-free survival was 10.25 months with EPd and 4.67 months with Pd (P = .0078).

Serious adverse events occurred in 22% of patients in the EPd arm and 15% in the Pd arm. The most frequent serious adverse events were pneumonia and respiratory tract infection.

Additional results from ELOQUENT-3 can be found in the full prescribing information for elotuzumab, which is available on the Empliciti website.

Bristol-Myers Squibb and AbbVie are codeveloping elotuzumab, with Bristol-Myers Squibb solely responsible for commercial activities.

[email protected]

The Food and Drug Administration has approved elotuzumab (Empliciti) in combination with pomalidomide and dexamethasone for adults with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

Elotuzumab is already approved in combination with lenalidomide and dexamethasone to treat adult myeloma patients who have received one to three prior therapies.

The FDA’s latest approval of elotuzumab is based on results from ELOQUENT-3. This phase 2 trial enrolled multiple myeloma patients who had refractory or relapsed disease and had received both lenalidomide and a proteasome inhibitor.

In the trial, patients were randomized to receive elotuzumab plus pomalidomide and dexamethasone (EPd, n = 60) or pomalidomide and dexamethasone (Pd, n = 57) in 28-day cycles until disease progression or unacceptable toxicity.

The overall response rate was 53.3% in the EPd arm and 26.3% in the Pd arm (P = .0029); the rate of complete response or stringent complete response was 8.3% and 1.8%, respectively.


Median progression-free survival was 10.25 months with EPd and 4.67 months with Pd (P = .0078).

Serious adverse events occurred in 22% of patients in the EPd arm and 15% in the Pd arm. The most frequent serious adverse events were pneumonia and respiratory tract infection.

Additional results from ELOQUENT-3 can be found in the full prescribing information for elotuzumab, which is available on the Empliciti website.

Bristol-Myers Squibb and AbbVie are codeveloping elotuzumab, with Bristol-Myers Squibb solely responsible for commercial activities.

[email protected]

Clinical question: Does B-type natriuretic peptide (BNP) have prognostic value outside of heart failure (HF) patients?

Background: BNP levels are influenced by both cardiac and extracardiac stimuli and thus might have prognostic value outside of the traditional use to guide therapy for HF patients.

Study design: Retrospective cohort study of the Vanderbilt electronic health record.

Setting: Vanderbilt University Medical Center, Nashville, Tenn.

Synopsis: The study evaluated 30,487 patients with at least two BNP values for 2002-2015. Within this cohort, 62% of patients did not have a HF diagnosis. Risk of death was elevated in all patients regardless of HF status as BNP values rose. An increase from the 25th to 75th percentile in BNP value was associated with an increased risk of death in non-HF patients (hazard ratio, 2.08; 95% confidence interval, 1.99-2.2). Additionally, in a multivariate analysis BNP was the strongest predictor of death, compared with traditional risk factors in both HF and non-HF patients. The main limitation to this study was the use of ICD codes for diagnosis of HF.

Bottom line: BNP has predictive value for risk of death in non-HF patients; as BNP levels rise, regardless of HF status, so does risk of death.



Citation: York MK et al. B-type natriuretic peptide levels and mortality in patients with and without heart failure. J Am Coll Cardiol. 2018 May 15;71(19):2079-88.

Dr. Abramowicz is an assistant professor in the division of hospital medicine, University of Colorado, Denver.

Clinical question: Does B-type natriuretic peptide (BNP) have prognostic value outside of heart failure (HF) patients?

Background: BNP levels are influenced by both cardiac and extracardiac stimuli and thus might have prognostic value outside of the traditional use to guide therapy for HF patients.

Study design: Retrospective cohort study of the Vanderbilt electronic health record.

Setting: Vanderbilt University Medical Center, Nashville, Tenn.

Synopsis: The study evaluated 30,487 patients with at least two BNP values for 2002-2015. Within this cohort, 62% of patients did not have a HF diagnosis. Risk of death was elevated in all patients regardless of HF status as BNP values rose. An increase from the 25th to 75th percentile in BNP value was associated with an increased risk of death in non-HF patients (hazard ratio, 2.08; 95% confidence interval, 1.99-2.2). Additionally, in a multivariate analysis BNP was the strongest predictor of death, compared with traditional risk factors in both HF and non-HF patients. The main limitation to this study was the use of ICD codes for diagnosis of HF.

Bottom line: BNP has predictive value for risk of death in non-HF patients; as BNP levels rise, regardless of HF status, so does risk of death.



Citation: York MK et al. B-type natriuretic peptide levels and mortality in patients with and without heart failure. J Am Coll Cardiol. 2018 May 15;71(19):2079-88.

Dr. Abramowicz is an assistant professor in the division of hospital medicine, University of Colorado, Denver.

Clinical question: Does B-type natriuretic peptide (BNP) have prognostic value outside of heart failure (HF) patients?

Background: BNP levels are influenced by both cardiac and extracardiac stimuli and thus might have prognostic value outside of the traditional use to guide therapy for HF patients.

Study design: Retrospective cohort study of the Vanderbilt electronic health record.

Setting: Vanderbilt University Medical Center, Nashville, Tenn.

Synopsis: The study evaluated 30,487 patients with at least two BNP values for 2002-2015. Within this cohort, 62% of patients did not have a HF diagnosis. Risk of death was elevated in all patients regardless of HF status as BNP values rose. An increase from the 25th to 75th percentile in BNP value was associated with an increased risk of death in non-HF patients (hazard ratio, 2.08; 95% confidence interval, 1.99-2.2). Additionally, in a multivariate analysis BNP was the strongest predictor of death, compared with traditional risk factors in both HF and non-HF patients. The main limitation to this study was the use of ICD codes for diagnosis of HF.

Bottom line: BNP has predictive value for risk of death in non-HF patients; as BNP levels rise, regardless of HF status, so does risk of death.



Citation: York MK et al. B-type natriuretic peptide levels and mortality in patients with and without heart failure. J Am Coll Cardiol. 2018 May 15;71(19):2079-88.

Dr. Abramowicz is an assistant professor in the division of hospital medicine, University of Colorado, Denver.

ANSWER

The correct interpretation includes sinus tachycardia with biatrial enlargement and ST- and T-wave abnormalities consistent with inferolateral ischemia.

Sinus tachycardia is evident from an atrial rate > 100 beats/min, with a consistent PR interval for each P and R wave.

Criteria for right atrial enlargement include tall P waves in leads II, III, and aVF, and for left atrial enlargement, P waves in lead I ≥ 110 ms with terminal negativity of the P wave in lead V₁ ≥ 1 mm². When both criteria are met, the diagnosis is biatrial enlargement.

The presence of ST elevation in lead V₄ and T-wave inversions in leads V₅ and V₆ and limb leads II, III, and aVF suggest inferolateral ischemia.

ANSWER

The correct interpretation includes sinus tachycardia with biatrial enlargement and ST- and T-wave abnormalities consistent with inferolateral ischemia.

Sinus tachycardia is evident from an atrial rate > 100 beats/min, with a consistent PR interval for each P and R wave.

Criteria for right atrial enlargement include tall P waves in leads II, III, and aVF, and for left atrial enlargement, P waves in lead I ≥ 110 ms with terminal negativity of the P wave in lead V₁ ≥ 1 mm². When both criteria are met, the diagnosis is biatrial enlargement.

The presence of ST elevation in lead V₄ and T-wave inversions in leads V₅ and V₆ and limb leads II, III, and aVF suggest inferolateral ischemia.

ANSWER

The correct interpretation includes sinus tachycardia with biatrial enlargement and ST- and T-wave abnormalities consistent with inferolateral ischemia.

Sinus tachycardia is evident from an atrial rate > 100 beats/min, with a consistent PR interval for each P and R wave.

Criteria for right atrial enlargement include tall P waves in leads II, III, and aVF, and for left atrial enlargement, P waves in lead I ≥ 110 ms with terminal negativity of the P wave in lead V₁ ≥ 1 mm². When both criteria are met, the diagnosis is biatrial enlargement.

The presence of ST elevation in lead V₄ and T-wave inversions in leads V₅ and V₆ and limb leads II, III, and aVF suggest inferolateral ischemia.

BOSTON – When surgeon Wendy R. Greene, MD, FACS, director of acute and critical care surgery at Emory University, Atlanta, asked a room of about 300 general surgeons at the annual clinical congress of the American College of Surgeons how many use needle aspiration first for breast abscesses, and how many use a scalpel, it was about a 50-50 split.

M. Alexander Otto/MDedge News

This divided response is why Dr. Greene addressed in her presentation the right approach to the problem of breast abscesses. In short, “for run-of-the-mill abscesses less than 5 cm, don’t get out the scalpel; get out the needle first,” she said.

Breast abscesses make women feel terrible. They have flulike symptoms, plus a warm, red, and tender bump on their breast. New mothers over age 30 years are most at risk, especially if they are past 40 weeks’ gestation.

There certainly are indications for the scalpel first. If the skin overlaying the abscess is dead, shiny, sloughing off, or leaking pus, or if the abscess is larger than 5 cm on ultrasound, a small stab incision is in order, and it should be made at the maximum point of fluctuation, after numbing the surrounding tissue. Put a wipe in place to catch the pus, debride as necessary, and “irrigate, irrigate, irrigate,” Dr. Greene said.

She uses suction to make sure all the pus is out, then injects a lidocaine into the cavity for pain control and lets it rest a few minutes before another round of suction.

Septic, deteriorating patients, and the immunocompromised, need a larger incision and drainage, with IV antibiotics in the hospital, but even in those cases, “avoid placing percutaneous drains; there’s rarely a role for them in modern management of breast abscesses.” Women will have poorer results and poorer cosmesis, Dr. Greene said.

Aggressive drainage isn’t necessary most of the time, and it can destroy healthy tissue and leave new mothers with breastfeeding problems and milk fistulas. There’s also a risk for scarring, deformity, and loss of the ability to lactate.

An 18-21 gauge needle with local anesthetic is usually enough. The lesion should be obvious on ultrasound, and it’s useful to guide the needle and ensure the cavity collapses on aspiration.

Dr. Greene said it also is important to culture milk in new mothers, and culture her infant’s nose and mouth, because cracked skin on the breast can let germs from nursing into the milk ducts.

Women are sent home after aspiration with antibiotics for 7-10 days, ones that are safe for nursing infants. They might be back with another abscess in a few weeks, so it’s important to be patient and ready for ongoing treatment.

The ultimate worry with recurrent cases is that a breast mass is blocking a milk duct, so mammography is often in order for repeat patients, especially with a family history of breast cancer. Wait until the acute infection has died down; a mammograph can be too painful otherwise, Dr. Greene said.

In the meantime, let infants nurse. They “are a great way to help drain the breast,” she said.

Dr. Greene had no relevant disclosures.

[email protected]

BOSTON – When surgeon Wendy R. Greene, MD, FACS, director of acute and critical care surgery at Emory University, Atlanta, asked a room of about 300 general surgeons at the annual clinical congress of the American College of Surgeons how many use needle aspiration first for breast abscesses, and how many use a scalpel, it was about a 50-50 split.

M. Alexander Otto/MDedge News

This divided response is why Dr. Greene addressed in her presentation the right approach to the problem of breast abscesses. In short, “for run-of-the-mill abscesses less than 5 cm, don’t get out the scalpel; get out the needle first,” she said.

Breast abscesses make women feel terrible. They have flulike symptoms, plus a warm, red, and tender bump on their breast. New mothers over age 30 years are most at risk, especially if they are past 40 weeks’ gestation.

There certainly are indications for the scalpel first. If the skin overlaying the abscess is dead, shiny, sloughing off, or leaking pus, or if the abscess is larger than 5 cm on ultrasound, a small stab incision is in order, and it should be made at the maximum point of fluctuation, after numbing the surrounding tissue. Put a wipe in place to catch the pus, debride as necessary, and “irrigate, irrigate, irrigate,” Dr. Greene said.

She uses suction to make sure all the pus is out, then injects a lidocaine into the cavity for pain control and lets it rest a few minutes before another round of suction.

Septic, deteriorating patients, and the immunocompromised, need a larger incision and drainage, with IV antibiotics in the hospital, but even in those cases, “avoid placing percutaneous drains; there’s rarely a role for them in modern management of breast abscesses.” Women will have poorer results and poorer cosmesis, Dr. Greene said.

Aggressive drainage isn’t necessary most of the time, and it can destroy healthy tissue and leave new mothers with breastfeeding problems and milk fistulas. There’s also a risk for scarring, deformity, and loss of the ability to lactate.

An 18-21 gauge needle with local anesthetic is usually enough. The lesion should be obvious on ultrasound, and it’s useful to guide the needle and ensure the cavity collapses on aspiration.

Dr. Greene said it also is important to culture milk in new mothers, and culture her infant’s nose and mouth, because cracked skin on the breast can let germs from nursing into the milk ducts.

Women are sent home after aspiration with antibiotics for 7-10 days, ones that are safe for nursing infants. They might be back with another abscess in a few weeks, so it’s important to be patient and ready for ongoing treatment.

The ultimate worry with recurrent cases is that a breast mass is blocking a milk duct, so mammography is often in order for repeat patients, especially with a family history of breast cancer. Wait until the acute infection has died down; a mammograph can be too painful otherwise, Dr. Greene said.

In the meantime, let infants nurse. They “are a great way to help drain the breast,” she said.

Dr. Greene had no relevant disclosures.

[email protected]

BOSTON – When surgeon Wendy R. Greene, MD, FACS, director of acute and critical care surgery at Emory University, Atlanta, asked a room of about 300 general surgeons at the annual clinical congress of the American College of Surgeons how many use needle aspiration first for breast abscesses, and how many use a scalpel, it was about a 50-50 split.

M. Alexander Otto/MDedge News

This divided response is why Dr. Greene addressed in her presentation the right approach to the problem of breast abscesses. In short, “for run-of-the-mill abscesses less than 5 cm, don’t get out the scalpel; get out the needle first,” she said.

Breast abscesses make women feel terrible. They have flulike symptoms, plus a warm, red, and tender bump on their breast. New mothers over age 30 years are most at risk, especially if they are past 40 weeks’ gestation.

There certainly are indications for the scalpel first. If the skin overlaying the abscess is dead, shiny, sloughing off, or leaking pus, or if the abscess is larger than 5 cm on ultrasound, a small stab incision is in order, and it should be made at the maximum point of fluctuation, after numbing the surrounding tissue. Put a wipe in place to catch the pus, debride as necessary, and “irrigate, irrigate, irrigate,” Dr. Greene said.

She uses suction to make sure all the pus is out, then injects a lidocaine into the cavity for pain control and lets it rest a few minutes before another round of suction.

Septic, deteriorating patients, and the immunocompromised, need a larger incision and drainage, with IV antibiotics in the hospital, but even in those cases, “avoid placing percutaneous drains; there’s rarely a role for them in modern management of breast abscesses.” Women will have poorer results and poorer cosmesis, Dr. Greene said.

Aggressive drainage isn’t necessary most of the time, and it can destroy healthy tissue and leave new mothers with breastfeeding problems and milk fistulas. There’s also a risk for scarring, deformity, and loss of the ability to lactate.

An 18-21 gauge needle with local anesthetic is usually enough. The lesion should be obvious on ultrasound, and it’s useful to guide the needle and ensure the cavity collapses on aspiration.

Dr. Greene said it also is important to culture milk in new mothers, and culture her infant’s nose and mouth, because cracked skin on the breast can let germs from nursing into the milk ducts.

Women are sent home after aspiration with antibiotics for 7-10 days, ones that are safe for nursing infants. They might be back with another abscess in a few weeks, so it’s important to be patient and ready for ongoing treatment.

The ultimate worry with recurrent cases is that a breast mass is blocking a milk duct, so mammography is often in order for repeat patients, especially with a family history of breast cancer. Wait until the acute infection has died down; a mammograph can be too painful otherwise, Dr. Greene said.

In the meantime, let infants nurse. They “are a great way to help drain the breast,” she said.

Dr. Greene had no relevant disclosures.

[email protected]

Exercise increases endurance, muscle strength, and functional performance with corresponding gains in mobility, survival, and quality of life.¹ However, even with these benefits and improvements in clinical outcomes, only 15% of adults aged ≥ 65 years follow current guidelines for exercise.² Despite their prior military training, the majority of veterans do not meet physical activity recommendations.³ Time, travel, and support are common barriers to exercise participation and adherence—barriers that are further amplified among older adults.

The Veterans Health Administration (VHA) is recognized as a world leader in telehealth service development. Currently, 677,000 veterans have received telehealth services, which represents 12% of the 5.6 million veterans under VHA care.⁴ Clinical video telehealth (CVT) is widely used within the VHA system to deliver health care that otherwise would not be available to veterans. Veterans who have difficulty traveling to the nearest US Department of Veteran Affairs (VA) medical center (VAMC) can access CVT programs at a participating VHA community-based outpatient clinic (CBOC). The VA has more than 45 CVT programs, including programs for mental health, weight management, cardiology, and dermatology. Outside the VA, cardiac exercise rehabilitation provided by CVT has been shown to be as effective as center-based programs in improving cardiovascular risk factors and functional capacity.⁵ A VHA exercise program that leveraged CVT resources and was dedicated to older adults with a wide range of comorbid conditions would have a high impact on the health and well-being of older veterans.

Gerofit is a VHA clinical demonstration program of supervised center-based exercise for veterans aged ≥ 65 years. Developed at the Durham VAMC Geriatric Research, Education, and Clinical Center (GRECC) in North Carolina, it has demonstrated improved clinical outcomes, including physical function, mobility, quality of life, and survival.^6-10 The program offers veterans individualized exercise in a group setting that focuses on improving endurance, strength, and balance. The exercise prescription is based on the patient’s physical limitations as identified in a physical performance assessment.

With support from VHA Geriatric Extended Care (GEC) and the Office of Rural Health (ORH), Gerofit was implemented in 10 VAMCs across 8 VISNs. However, barriers such as travel time, distance, and transportation limit participation. Previously, we found that rural veterans lack access to exercise programs.^11,12 Although some do aerobic exercise (AEX), most do not do resistance training (RT), though they are willing to learn. Access to Gerofit for rural veterans is expanding with recent support from the ORH Enterprise Wide Initiative. Rural program expansion includes several different Gerofit initiatives, many involving CBOCs.

The Salem VAMC Gerofit program sought to adapt the facility-based assessment and exercise procedures into a self-reliant CVT class for its CBOCs. This article describes the development of the Salem VAMC Gerofit CVT program, hereafter referred to as Tele-Gerofit.

Related: Expanding the Scope of Telemedicine in Gastroenterology

Program Design

Gerofit was established in 1986 at the Durham GRECC as an exercise and health promotion program for veterans aged ≥ 65 years.¹³ Its goal is to prevent or improve functional decline from physical inactivity and age-related conditions. Gerofit targets the geriatric patient population and thus extends beyond cardiac and pulmonary rehabilitation or weight loss programs. The primary exclusion criteria are based on safety issues in the context of a group exercise setting of older adults and include oxygen dependency, unstable cardiac disease, and moderate-to-severe cognitive impairment.

To participate in Gerofit, veterans must be able to perform activities of daily living and self-manage an exercise prescription developed by the exercise instructor based on physical performance testing. These physical performance tests include measures that are independent predictors of disability, loss of independent living, and death, as well as surrogate measures of exercise capacity (eg, strength, endurance, balance).^14,15 A novel aspect of Gerofit is that the physical performance assessment is used not only to determine physical limitations, but also to individualize the exercise prescription based on the observed deficits in strength, endurance, or balance. These assessments are performed at initial enrollment; 3 months, 6 months, and 1 year later; and annually after that. Currently, the center-based Gerofit programs administer 5 items of the Senior Fitness Test: 6-minute walk, 10-meter walk (10-MWT), 30-second 1-arm curl, 30-second chair-stand test, and 8-foot up-and-go.¹⁵ The side-by-side, semitandem, and tandem standing balance tests from the short physical performance battery also are performed.¹⁶ In addition, participants complete a questionnaire that includes items from the physical functioning scale of the 12-Item Short Form Health Survey (SF-12).

After each assessment, the Gerofit exercise instructor reviews the results with the veteran and formulates an individualized exercise prescription along with goals for improvement. Veterans are encouraged to attend supervised center-based exercise sessions 3 times weekly. Classes are offered in a gym or fitness center at the VAMC or in leased space. Each patient uses a cue card that lists an exercise plan personalized for intensity and duration for aerobic exercise (AEX; eg, treadmill walking, stationary bicycling, arm ergometry), RT using dumbbells and weight equipment, and functional exercises for flexibility and balance. Some medical centers also offer yoga, tai chi, or dancing Gerofit classes.

For participants in the Durham Gerofit program, mortality decreased 25% over a decade (hazard ratio, 0.75; 95% CI, 0.61-0.91).⁹ A substudy that included the Psychological General Well-Being Index found that 81% of participants significantly increased their score after 1 year.⁷ Observed initial improvement in physical performance has been sustained over 5 years.^10,17 One-year results from the recent Gerofit expansion to 6 other VAMCs showed clinically and statistically significantly improved physical performance from baseline to 3-, 6-, and 12-month follow-up.¹⁸

Adaptation of Gerofit to CVT Delivery

Initial work. The Greater Los Angeles VAMC Gerofit program conducted a pilot CVT exercise class of 6 veterans at the rural Bakersfield CBOC in California.¹⁹ Each week, an exercise instructor broadcast a 60-minute exercise class that included warm-up, RT with bands, progressive balance training, and flexibility. Trained student volunteers from California State University in Bakersfield kinesiology program were on site at the Bakersfield CBOC to perform the assessments and aid in exercises during the CVT sessions. Despite the lack of AEX per se, veterans showed significant improvement in endurance as measured by an increase in the number of steps completed in 2 minutes at the 3-month assessment (P = .049). Although exercises were not delivered in a circuit format, the improved endurance supported the potential for cardiovascular benefit from RT in older adults.

This pilot project also demonstrated that key components of the Gerofit program could be delivered safely by telehealth with onsite supervision. The Miami VA Healthcare System also offers CVT Gerofit exercise classes broadcast to the rural Florida CBOCs of Key Largo and Homestead.¹¹ The exercise activities offered for the Miami CVT participants incorporate components of AEX (calisthenics) and RT (resistance bands). Veterans enjoyed the classes, and adherence was good. However, availability of staff and space are an ongoing challenge.

In Key Largo, 5 veterans participated before the CVT classes were placed on hold owing to the demands of other CVT programs and limited availability of the telehealth clinical technician (TCT). The Homestead CBOC continues to offer CVT Gerofit exercise classes and has 6 regular participants. Notably, the physical space at the Homestead CBOC is smaller than that at the Key Largo CBOC; the Homestead CBOC has adjusted by shifting to exercises performed while standing or sitting, ensuring participants’ safety and satisfaction.

The Baltimore, Maryland VAMC Gerofit program offers other innovative CVT exercise classes, including a tai chi class, and a class with exercise performed while sitting in a chair. Although the Baltimore VAMC CVT exercise classes do not have the scope of the center-based exercise prescriptions, they are unique in that they are broadcast not only to their affiliated CBOCs, but also other Gerofit programs in different VISNs.

Related: Telehealth for Rural Veterans With Neurologic Disorders

Salem VAMC Gerofit Program. The center-based Salem VAMC Gerofit program was established in July 2015. In fiscal year 2017, its dedicated exercise facility had more than 5,000 patient visits. Despite the program’s success, we prioritized establishing Tele-Gerofit because of the medical center’s rural location in southwest Virginia and the large number of veterans who receive care at CBOCs. Therefore, much as with the pilot CVT Gerofit classes in Los Angeles and Miami, the target setting was rural CBOCs. The goal for Salem VAMC Tele-Gerofit was to modify Gerofit delivery to the CVT format and a CBOC setting with minimal modification of the content and personnel requirements of both physical performance testing and exercise training procedures. 

Adjustments for CBOC Setting. The enrollment process for Tele-Gerofit is the same as that for the center-based program. To start, a veteran’s primary care provider reviews the list of eligibility criteria and, if the veteran qualifies, places a consult. A Gerofit team member then contacts the veteran by phone to describe the program and schedule an assessment. At the baseline physical performance assessment, American College of Sports Medicine guidelines on exercise participation, health screening, and exercise intensity are used to evaluate veterans and rank them by their cardiovascular risk.²⁰ All new program participants start with low-intensity exercise and gradually progress to recommended levels of exercise. Before starting an exercise class, participants are instructed on use of the 10-point rating of perceived exertion (RPE).

Each CBOC site is supplied with an RPE poster that is displayed for participants’ use. During a Tele-Gerofit class, the exercise instructor asks participants to periodically report their RPE. This class differs slightly from the center-based exercise sessions in which RPE is primarily assessed when a different exercise is introduced or the duration or intensity of an exercise is increased. The Gerofit instructor monitors exercise and treatment fidelity, but the onsite TCT observes for safety during class. The TCT also takes initial vital signs and sets up the room for the class. Emergency contacts and procedures are posted in each CBOC CVT room and are available to the center-based exercise instructor. Because the CBOCs are not inside medical facilities, some CBOC directors have asked that heart rate monitors be used as an extra safety precaution to ensure that high-risk participants do not exceed a heart rate limit that may be set by their cardiologists.

Modifications to Physical Performance Assessment. Physical performance testing had to be adapted to the small rooms available at the CBOCs. For measuring normal gait speed, the 10-MWT was replaced with the 4-meter walk test (4-MWT). The 4-MWT has excellent test–retest reliability with an intraclass correlation coefficient (ICC) of 0.93, but the discrepancy in gait speed between the 4-MWT and the 10-MWT is such that the tests cannot be used interchangeably.²¹ For measuring endurance, the 6-minute walk test was replaced with the 2-minute step test (2-MST). In older adults, the 2-MST has a moderate correlation with 6-minute walk distance (r = 0.36; P = .04) and high reliability (ICC, 0.90).^15,22 The 30-second 1-arm curl, the 30-second chair-stand test, and the 8-foot up-and-go test are performed without modification and require only dumbbells, a chair without wheels, and a stopwatch.

The exercise instructor at the Salem VAMC conducts physical performance testing by 2-way videoconferencing with the veteran in a room at the CBOC. The TCT at the CBOC assists by measuring and demarcating 4 meters on the floor and a designated height on the wall for knee elevation for 4-MWT and 2-MST, respectively. The TCT remains in the room during the assessment visit. Except for taking vital signs before and after the physical performance assessment, the TCT does not participate in the testing. To date, more than 20 physical performance assessments have been conducted without difficulty at Salem-affiliated CBOCs. The primary challenge has been scheduling the room with CVT equipment (ie, camera and screen) for the 30-minute individual assessment session, which occurs on a rolling basis as individuals are enrolled and followed.

After the assessment is completed, the exercise instructor reviews the results with the participant and provides feedback on areas in need of improvement. However, these education sessions can be lengthy and are best supported by giving the patient a personalized handout. A goal of Tele-Gerofit is to improve the education session by following up with a phone call to discuss material that is mailed to the veteran; this material includes the questionnaire used in the parent program.

Functional Circuit Exercise. In Tele-Gerofit, exercise training is delivered by CVT broadcast from the Salem VAMC to veterans in a room (equipped with steps, dumbbells, chairs, and bands) at the CBOC. This type of exercise training, which uses only mobile equipment and plyometric (weight-bearing) exercises, is referred to as functional exercise. The AEX includes marching in place, moving on and off a raised step, and body-weight exercises, while RT uses dumbbells, resistance bands, and plyometric exercises (Table 2). 

Progression of intensity is achieved by increasing the rate of stepping and the size of the steps (AEX) or the number of repetitions and the weight of the dumbbells or bands (RT). Each veteran exercises at an intensity level that is appropriate for his or her baseline limitations and medical conditions. The exercise instructor uses different forms of the same equipment (eg, heavier dumbbells, higher steps) to vary intensity among individuals while having them perform the same exercises as a group. The challenge is to adjust the pace of the AEX or the timing of the RT repetitions for individuals new to the class.

Delivery of exercise training in the form of circuits allows for a diverse exercise program in a setting with limited space. Circuit training is an exercise modality that consists of a series of different exercises, each usually completed in 30 to 60 seconds, with minimal rest between each type of exercise. Each Tele-Gerofit circuit has a mix of AEX and RT exercises performed for 3 minutes consecutively (Figure). 

The design of the circuit training can be adjusted based on the number of individuals in the class. Larger classes can be split into 2 groups that alternate between exercise sets, while smaller classes have 1 group performing the same exercise set and then rotating to either the AEX or RT set. Total exercise time to complete the circuit depends on the number of different exercises, number of repetitions, and the rest between repetitions and the different exercises. In this way, total exercise time can be made shorter or longer depending on the veteran’s capacity.

Frequency. Tele-Gerofit exercise classes are currently offered twice weekly and last about 1 hour, which includes warm-up (8-10 minutes), functional circuit training (40 minutes), and cooldown/stretching (8-10 minutes). A challenge for the exercise instructor is the need to provide ongoing clear instructions both to the class and to individuals as needed. As the exercise prescription for each patient is based on physical performance testing, the exercise instructor for the training must be familiar with the test results. Derivation of the exercise prescription in Tele-Gerofit follows the same process as center-based Gerofit.

Each patient is given an exercise prescription written to address any impairments noted in the different domains of the physical performance assessment, scored using age and sex percentiles. For instance, individuals scoring poorly on lower body strength are given specific lower body strengthening exercises. Participants are given an exercise program that guides them toward achieving recommended physical activity guidelines using their RPE to modulate each exercise. Duration and intensity of each type of planned exercise are formally discussed after initial and follow-up assessments. In addition, exercise training is informally progressed throughout the program. For Tele-Gerofit, instructors must design each class with the group in mind while being prepared for modifications and specific changes for individuals.

Discussion

Tele-Gerofit adapts the well-established center-based Gerofit program to be executed without an exercise facility while maintaining the content of the evidence-based procedures. Physical performance testing and exercise training were modified, adding elements necessary for CVT assessments and classes to be broadcast from the Salem VAMC to its affiliated CBOCs. Tele-Gerofit exercises are performed in a circuit style that allows a veteran or small structured groups of veterans to move among exercises and requires less space than traditional group exercise does. Safety and monitoring concerns are addressed with a safety procedure that includes emergency plans for each site, prescreening of enrolled participants, and monitoring of exercise intensity in accordance with national guidelines.¹ Similar to the center-based Gerofit program, the exercise prescription is tailored to each veteran’s physical limitations based on initial and ongoing assessment of physical performance. Tele-Gerofit physical performance testing fulfills the same need with only a few modifications using validated measures. Tele-Gerofit assessments are administered by CVT without the need for additional staff on site.

Adaptation of center-based Gerofit exercise classes to Tele-Gerofit is a major innovation. Use of a circuit exercise design was supported by findings in older adults that RT alone, when performed quickly with minimal rest between each set and exercise station, increases both aerobic capacity and strength.^23,24 Older adult RT trials that compared circuit RT with traditional RT found that strength gains are comparable between circuit and traditional RT.^24-26 Working with adults aged > 60 years, Takeshima and colleagues conducted a trial of circuit exercise with added callisthenic exercises performed in place between RT on exercise machines.²⁷ This dual-modality (AEX+RT) circuit approach was well tolerated and effective, increasing aerobic capacity and strength. Unfortunately, the resistance exercise machines used in those circuit exercise studies and in the center-based Gerofit program are not an option for Tele-Gerofit.

The requirement for an exercise facility was removed by designing Tele-Gerofit exercise to include only functional exercises that rely on body weight or small mobile exercise equipment. Although popular among young adults, functional circuit exercise is understudied in older adults. Recently, a 12-week functional circuit exercise intervention in frail elderly adults demonstrated significant improvements in gait speed and the timed chair-stand test.²⁸ A pilot observational study of Gerofit participants at the Canandaigua VAMC offered 27 veterans functional circuit exercise instead of their traditional exercise facility class and found larger increases in the timed chair-stand test and 6-minute walk distance compared with 11 Gerofit participants in the traditional program.²⁹

This Tele-Gerofit exercise training combines functional and circuit exercise strategies into telehealth delivery. However, its effect on physical performance remains to be demonstrated. To address this question, we are conducting a single-arm pilot study of Tele-Gerofit with CVT broadcast to 3 Salem CBOC affiliates (Wytheville, Staunton, and Danville, Virginia). The goal is to determine the effect on physical performance and collect feasibility data, including attendance rate and patient satisfaction with the video broadcast. In addition, we are planning an effectiveness trial to compare the impact of functional circuit exercise delivered in person (center based, not CVT) with the parent Gerofit exercise program on direct measures of endurance and strength, in addition to physical performance.

Related: Setting and Method of Measurement Affect Blood Pressure Readings in Older Veterans

Implementation research is needed to determine how Tele-Gerofit can be disseminated to other VAMCs and community-based centers beyond CBOCs. Although the cost of the equipment used to implement Tele-Gerofit is minimal, the program requires dedicated and experienced exercise instructors, and the sharing of telehealth resources with other clinical programs. The authors expect that a diverse group of stakeholders is needed across service lines of primary care, geriatrics and extended care, physical medicine and rehabilitation, and telehealth. Of note, this multidisciplinary collaboration is a hallmark of the Gerofit program. The recent success of the implementation of center-based Gerofit in VAMCs across the US demonstrates the program’s flexibility and robust results.¹⁸

Plans also include refining strategies for physical performance testing and exercise monitoring. For instance, we would like to adapt telehealth technology for heart rate monitors that can be worn by high-risk veterans at the CBOC and viewed in real time by the exercise instructor. Gerofit is currently being developed nationally for home use, which would remove the need to travel to a CBOC.

Conclusion

Gerofit, which is designed to help older veterans maintain independent living and prevent disability, has been demonstrated to improve quality of life and survival. Our goal has been to adapt Gerofit to CVT and provide a supervised, individualized exercise program in a group setting—a program that can be widely disseminated. Salem VAMC Tele-Gerofit is an innovative and prescriptive program that delivers CVT functional circuit exercise training to remote locations without the need for stationary exercise equipment. This approach has the potential to become an effective and feasible exercise strategy for preventing and minimizing disability in the increasing population of older veterans. Work is needed to determine whether Tele-Gerofit provides a rapid translation of Gerofit to clinical practice and improved outcomes with substantial cost savings from reduced hospitalization and institutionalization.

Acknowledgments
Gerofit has been funded by the Veterans Health Affairs Office of Geriatrics and Extended Care Non-Institutional Long-Term Care Funding and Mentored Partnership Program, and the Veterans Health Affairs Office of Rural Health Rural Enterprise-Wide Initiative.

The authors thank Kim Birkett, MPH, for assistance in editing, references, and graphics and the staff at the Wytheville, Staunton, and Danville community-based outpatient clinics for their support.

Exercise increases endurance, muscle strength, and functional performance with corresponding gains in mobility, survival, and quality of life.¹ However, even with these benefits and improvements in clinical outcomes, only 15% of adults aged ≥ 65 years follow current guidelines for exercise.² Despite their prior military training, the majority of veterans do not meet physical activity recommendations.³ Time, travel, and support are common barriers to exercise participation and adherence—barriers that are further amplified among older adults.

The Veterans Health Administration (VHA) is recognized as a world leader in telehealth service development. Currently, 677,000 veterans have received telehealth services, which represents 12% of the 5.6 million veterans under VHA care.⁴ Clinical video telehealth (CVT) is widely used within the VHA system to deliver health care that otherwise would not be available to veterans. Veterans who have difficulty traveling to the nearest US Department of Veteran Affairs (VA) medical center (VAMC) can access CVT programs at a participating VHA community-based outpatient clinic (CBOC). The VA has more than 45 CVT programs, including programs for mental health, weight management, cardiology, and dermatology. Outside the VA, cardiac exercise rehabilitation provided by CVT has been shown to be as effective as center-based programs in improving cardiovascular risk factors and functional capacity.⁵ A VHA exercise program that leveraged CVT resources and was dedicated to older adults with a wide range of comorbid conditions would have a high impact on the health and well-being of older veterans.

Gerofit is a VHA clinical demonstration program of supervised center-based exercise for veterans aged ≥ 65 years. Developed at the Durham VAMC Geriatric Research, Education, and Clinical Center (GRECC) in North Carolina, it has demonstrated improved clinical outcomes, including physical function, mobility, quality of life, and survival.^6-10 The program offers veterans individualized exercise in a group setting that focuses on improving endurance, strength, and balance. The exercise prescription is based on the patient’s physical limitations as identified in a physical performance assessment.

With support from VHA Geriatric Extended Care (GEC) and the Office of Rural Health (ORH), Gerofit was implemented in 10 VAMCs across 8 VISNs. However, barriers such as travel time, distance, and transportation limit participation. Previously, we found that rural veterans lack access to exercise programs.^11,12 Although some do aerobic exercise (AEX), most do not do resistance training (RT), though they are willing to learn. Access to Gerofit for rural veterans is expanding with recent support from the ORH Enterprise Wide Initiative. Rural program expansion includes several different Gerofit initiatives, many involving CBOCs.

The Salem VAMC Gerofit program sought to adapt the facility-based assessment and exercise procedures into a self-reliant CVT class for its CBOCs. This article describes the development of the Salem VAMC Gerofit CVT program, hereafter referred to as Tele-Gerofit.

Related: Expanding the Scope of Telemedicine in Gastroenterology

Program Design

Gerofit was established in 1986 at the Durham GRECC as an exercise and health promotion program for veterans aged ≥ 65 years.¹³ Its goal is to prevent or improve functional decline from physical inactivity and age-related conditions. Gerofit targets the geriatric patient population and thus extends beyond cardiac and pulmonary rehabilitation or weight loss programs. The primary exclusion criteria are based on safety issues in the context of a group exercise setting of older adults and include oxygen dependency, unstable cardiac disease, and moderate-to-severe cognitive impairment.

To participate in Gerofit, veterans must be able to perform activities of daily living and self-manage an exercise prescription developed by the exercise instructor based on physical performance testing. These physical performance tests include measures that are independent predictors of disability, loss of independent living, and death, as well as surrogate measures of exercise capacity (eg, strength, endurance, balance).^14,15 A novel aspect of Gerofit is that the physical performance assessment is used not only to determine physical limitations, but also to individualize the exercise prescription based on the observed deficits in strength, endurance, or balance. These assessments are performed at initial enrollment; 3 months, 6 months, and 1 year later; and annually after that. Currently, the center-based Gerofit programs administer 5 items of the Senior Fitness Test: 6-minute walk, 10-meter walk (10-MWT), 30-second 1-arm curl, 30-second chair-stand test, and 8-foot up-and-go.¹⁵ The side-by-side, semitandem, and tandem standing balance tests from the short physical performance battery also are performed.¹⁶ In addition, participants complete a questionnaire that includes items from the physical functioning scale of the 12-Item Short Form Health Survey (SF-12).

After each assessment, the Gerofit exercise instructor reviews the results with the veteran and formulates an individualized exercise prescription along with goals for improvement. Veterans are encouraged to attend supervised center-based exercise sessions 3 times weekly. Classes are offered in a gym or fitness center at the VAMC or in leased space. Each patient uses a cue card that lists an exercise plan personalized for intensity and duration for aerobic exercise (AEX; eg, treadmill walking, stationary bicycling, arm ergometry), RT using dumbbells and weight equipment, and functional exercises for flexibility and balance. Some medical centers also offer yoga, tai chi, or dancing Gerofit classes.

For participants in the Durham Gerofit program, mortality decreased 25% over a decade (hazard ratio, 0.75; 95% CI, 0.61-0.91).⁹ A substudy that included the Psychological General Well-Being Index found that 81% of participants significantly increased their score after 1 year.⁷ Observed initial improvement in physical performance has been sustained over 5 years.^10,17 One-year results from the recent Gerofit expansion to 6 other VAMCs showed clinically and statistically significantly improved physical performance from baseline to 3-, 6-, and 12-month follow-up.¹⁸

Adaptation of Gerofit to CVT Delivery

Initial work. The Greater Los Angeles VAMC Gerofit program conducted a pilot CVT exercise class of 6 veterans at the rural Bakersfield CBOC in California.¹⁹ Each week, an exercise instructor broadcast a 60-minute exercise class that included warm-up, RT with bands, progressive balance training, and flexibility. Trained student volunteers from California State University in Bakersfield kinesiology program were on site at the Bakersfield CBOC to perform the assessments and aid in exercises during the CVT sessions. Despite the lack of AEX per se, veterans showed significant improvement in endurance as measured by an increase in the number of steps completed in 2 minutes at the 3-month assessment (P = .049). Although exercises were not delivered in a circuit format, the improved endurance supported the potential for cardiovascular benefit from RT in older adults.

This pilot project also demonstrated that key components of the Gerofit program could be delivered safely by telehealth with onsite supervision. The Miami VA Healthcare System also offers CVT Gerofit exercise classes broadcast to the rural Florida CBOCs of Key Largo and Homestead.¹¹ The exercise activities offered for the Miami CVT participants incorporate components of AEX (calisthenics) and RT (resistance bands). Veterans enjoyed the classes, and adherence was good. However, availability of staff and space are an ongoing challenge.

In Key Largo, 5 veterans participated before the CVT classes were placed on hold owing to the demands of other CVT programs and limited availability of the telehealth clinical technician (TCT). The Homestead CBOC continues to offer CVT Gerofit exercise classes and has 6 regular participants. Notably, the physical space at the Homestead CBOC is smaller than that at the Key Largo CBOC; the Homestead CBOC has adjusted by shifting to exercises performed while standing or sitting, ensuring participants’ safety and satisfaction.

The Baltimore, Maryland VAMC Gerofit program offers other innovative CVT exercise classes, including a tai chi class, and a class with exercise performed while sitting in a chair. Although the Baltimore VAMC CVT exercise classes do not have the scope of the center-based exercise prescriptions, they are unique in that they are broadcast not only to their affiliated CBOCs, but also other Gerofit programs in different VISNs.

Related: Telehealth for Rural Veterans With Neurologic Disorders

Salem VAMC Gerofit Program. The center-based Salem VAMC Gerofit program was established in July 2015. In fiscal year 2017, its dedicated exercise facility had more than 5,000 patient visits. Despite the program’s success, we prioritized establishing Tele-Gerofit because of the medical center’s rural location in southwest Virginia and the large number of veterans who receive care at CBOCs. Therefore, much as with the pilot CVT Gerofit classes in Los Angeles and Miami, the target setting was rural CBOCs. The goal for Salem VAMC Tele-Gerofit was to modify Gerofit delivery to the CVT format and a CBOC setting with minimal modification of the content and personnel requirements of both physical performance testing and exercise training procedures. 

Adjustments for CBOC Setting. The enrollment process for Tele-Gerofit is the same as that for the center-based program. To start, a veteran’s primary care provider reviews the list of eligibility criteria and, if the veteran qualifies, places a consult. A Gerofit team member then contacts the veteran by phone to describe the program and schedule an assessment. At the baseline physical performance assessment, American College of Sports Medicine guidelines on exercise participation, health screening, and exercise intensity are used to evaluate veterans and rank them by their cardiovascular risk.²⁰ All new program participants start with low-intensity exercise and gradually progress to recommended levels of exercise. Before starting an exercise class, participants are instructed on use of the 10-point rating of perceived exertion (RPE).

Each CBOC site is supplied with an RPE poster that is displayed for participants’ use. During a Tele-Gerofit class, the exercise instructor asks participants to periodically report their RPE. This class differs slightly from the center-based exercise sessions in which RPE is primarily assessed when a different exercise is introduced or the duration or intensity of an exercise is increased. The Gerofit instructor monitors exercise and treatment fidelity, but the onsite TCT observes for safety during class. The TCT also takes initial vital signs and sets up the room for the class. Emergency contacts and procedures are posted in each CBOC CVT room and are available to the center-based exercise instructor. Because the CBOCs are not inside medical facilities, some CBOC directors have asked that heart rate monitors be used as an extra safety precaution to ensure that high-risk participants do not exceed a heart rate limit that may be set by their cardiologists.

Modifications to Physical Performance Assessment. Physical performance testing had to be adapted to the small rooms available at the CBOCs. For measuring normal gait speed, the 10-MWT was replaced with the 4-meter walk test (4-MWT). The 4-MWT has excellent test–retest reliability with an intraclass correlation coefficient (ICC) of 0.93, but the discrepancy in gait speed between the 4-MWT and the 10-MWT is such that the tests cannot be used interchangeably.²¹ For measuring endurance, the 6-minute walk test was replaced with the 2-minute step test (2-MST). In older adults, the 2-MST has a moderate correlation with 6-minute walk distance (r = 0.36; P = .04) and high reliability (ICC, 0.90).^15,22 The 30-second 1-arm curl, the 30-second chair-stand test, and the 8-foot up-and-go test are performed without modification and require only dumbbells, a chair without wheels, and a stopwatch.

The exercise instructor at the Salem VAMC conducts physical performance testing by 2-way videoconferencing with the veteran in a room at the CBOC. The TCT at the CBOC assists by measuring and demarcating 4 meters on the floor and a designated height on the wall for knee elevation for 4-MWT and 2-MST, respectively. The TCT remains in the room during the assessment visit. Except for taking vital signs before and after the physical performance assessment, the TCT does not participate in the testing. To date, more than 20 physical performance assessments have been conducted without difficulty at Salem-affiliated CBOCs. The primary challenge has been scheduling the room with CVT equipment (ie, camera and screen) for the 30-minute individual assessment session, which occurs on a rolling basis as individuals are enrolled and followed.

After the assessment is completed, the exercise instructor reviews the results with the participant and provides feedback on areas in need of improvement. However, these education sessions can be lengthy and are best supported by giving the patient a personalized handout. A goal of Tele-Gerofit is to improve the education session by following up with a phone call to discuss material that is mailed to the veteran; this material includes the questionnaire used in the parent program.

Functional Circuit Exercise. In Tele-Gerofit, exercise training is delivered by CVT broadcast from the Salem VAMC to veterans in a room (equipped with steps, dumbbells, chairs, and bands) at the CBOC. This type of exercise training, which uses only mobile equipment and plyometric (weight-bearing) exercises, is referred to as functional exercise. The AEX includes marching in place, moving on and off a raised step, and body-weight exercises, while RT uses dumbbells, resistance bands, and plyometric exercises (Table 2). 

Progression of intensity is achieved by increasing the rate of stepping and the size of the steps (AEX) or the number of repetitions and the weight of the dumbbells or bands (RT). Each veteran exercises at an intensity level that is appropriate for his or her baseline limitations and medical conditions. The exercise instructor uses different forms of the same equipment (eg, heavier dumbbells, higher steps) to vary intensity among individuals while having them perform the same exercises as a group. The challenge is to adjust the pace of the AEX or the timing of the RT repetitions for individuals new to the class.

Delivery of exercise training in the form of circuits allows for a diverse exercise program in a setting with limited space. Circuit training is an exercise modality that consists of a series of different exercises, each usually completed in 30 to 60 seconds, with minimal rest between each type of exercise. Each Tele-Gerofit circuit has a mix of AEX and RT exercises performed for 3 minutes consecutively (Figure). 

The design of the circuit training can be adjusted based on the number of individuals in the class. Larger classes can be split into 2 groups that alternate between exercise sets, while smaller classes have 1 group performing the same exercise set and then rotating to either the AEX or RT set. Total exercise time to complete the circuit depends on the number of different exercises, number of repetitions, and the rest between repetitions and the different exercises. In this way, total exercise time can be made shorter or longer depending on the veteran’s capacity.

Frequency. Tele-Gerofit exercise classes are currently offered twice weekly and last about 1 hour, which includes warm-up (8-10 minutes), functional circuit training (40 minutes), and cooldown/stretching (8-10 minutes). A challenge for the exercise instructor is the need to provide ongoing clear instructions both to the class and to individuals as needed. As the exercise prescription for each patient is based on physical performance testing, the exercise instructor for the training must be familiar with the test results. Derivation of the exercise prescription in Tele-Gerofit follows the same process as center-based Gerofit.

Each patient is given an exercise prescription written to address any impairments noted in the different domains of the physical performance assessment, scored using age and sex percentiles. For instance, individuals scoring poorly on lower body strength are given specific lower body strengthening exercises. Participants are given an exercise program that guides them toward achieving recommended physical activity guidelines using their RPE to modulate each exercise. Duration and intensity of each type of planned exercise are formally discussed after initial and follow-up assessments. In addition, exercise training is informally progressed throughout the program. For Tele-Gerofit, instructors must design each class with the group in mind while being prepared for modifications and specific changes for individuals.

Discussion

Tele-Gerofit adapts the well-established center-based Gerofit program to be executed without an exercise facility while maintaining the content of the evidence-based procedures. Physical performance testing and exercise training were modified, adding elements necessary for CVT assessments and classes to be broadcast from the Salem VAMC to its affiliated CBOCs. Tele-Gerofit exercises are performed in a circuit style that allows a veteran or small structured groups of veterans to move among exercises and requires less space than traditional group exercise does. Safety and monitoring concerns are addressed with a safety procedure that includes emergency plans for each site, prescreening of enrolled participants, and monitoring of exercise intensity in accordance with national guidelines.¹ Similar to the center-based Gerofit program, the exercise prescription is tailored to each veteran’s physical limitations based on initial and ongoing assessment of physical performance. Tele-Gerofit physical performance testing fulfills the same need with only a few modifications using validated measures. Tele-Gerofit assessments are administered by CVT without the need for additional staff on site.

Adaptation of center-based Gerofit exercise classes to Tele-Gerofit is a major innovation. Use of a circuit exercise design was supported by findings in older adults that RT alone, when performed quickly with minimal rest between each set and exercise station, increases both aerobic capacity and strength.^23,24 Older adult RT trials that compared circuit RT with traditional RT found that strength gains are comparable between circuit and traditional RT.^24-26 Working with adults aged > 60 years, Takeshima and colleagues conducted a trial of circuit exercise with added callisthenic exercises performed in place between RT on exercise machines.²⁷ This dual-modality (AEX+RT) circuit approach was well tolerated and effective, increasing aerobic capacity and strength. Unfortunately, the resistance exercise machines used in those circuit exercise studies and in the center-based Gerofit program are not an option for Tele-Gerofit.

The requirement for an exercise facility was removed by designing Tele-Gerofit exercise to include only functional exercises that rely on body weight or small mobile exercise equipment. Although popular among young adults, functional circuit exercise is understudied in older adults. Recently, a 12-week functional circuit exercise intervention in frail elderly adults demonstrated significant improvements in gait speed and the timed chair-stand test.²⁸ A pilot observational study of Gerofit participants at the Canandaigua VAMC offered 27 veterans functional circuit exercise instead of their traditional exercise facility class and found larger increases in the timed chair-stand test and 6-minute walk distance compared with 11 Gerofit participants in the traditional program.²⁹

This Tele-Gerofit exercise training combines functional and circuit exercise strategies into telehealth delivery. However, its effect on physical performance remains to be demonstrated. To address this question, we are conducting a single-arm pilot study of Tele-Gerofit with CVT broadcast to 3 Salem CBOC affiliates (Wytheville, Staunton, and Danville, Virginia). The goal is to determine the effect on physical performance and collect feasibility data, including attendance rate and patient satisfaction with the video broadcast. In addition, we are planning an effectiveness trial to compare the impact of functional circuit exercise delivered in person (center based, not CVT) with the parent Gerofit exercise program on direct measures of endurance and strength, in addition to physical performance.

Related: Setting and Method of Measurement Affect Blood Pressure Readings in Older Veterans

Implementation research is needed to determine how Tele-Gerofit can be disseminated to other VAMCs and community-based centers beyond CBOCs. Although the cost of the equipment used to implement Tele-Gerofit is minimal, the program requires dedicated and experienced exercise instructors, and the sharing of telehealth resources with other clinical programs. The authors expect that a diverse group of stakeholders is needed across service lines of primary care, geriatrics and extended care, physical medicine and rehabilitation, and telehealth. Of note, this multidisciplinary collaboration is a hallmark of the Gerofit program. The recent success of the implementation of center-based Gerofit in VAMCs across the US demonstrates the program’s flexibility and robust results.¹⁸

Plans also include refining strategies for physical performance testing and exercise monitoring. For instance, we would like to adapt telehealth technology for heart rate monitors that can be worn by high-risk veterans at the CBOC and viewed in real time by the exercise instructor. Gerofit is currently being developed nationally for home use, which would remove the need to travel to a CBOC.

Conclusion

Gerofit, which is designed to help older veterans maintain independent living and prevent disability, has been demonstrated to improve quality of life and survival. Our goal has been to adapt Gerofit to CVT and provide a supervised, individualized exercise program in a group setting—a program that can be widely disseminated. Salem VAMC Tele-Gerofit is an innovative and prescriptive program that delivers CVT functional circuit exercise training to remote locations without the need for stationary exercise equipment. This approach has the potential to become an effective and feasible exercise strategy for preventing and minimizing disability in the increasing population of older veterans. Work is needed to determine whether Tele-Gerofit provides a rapid translation of Gerofit to clinical practice and improved outcomes with substantial cost savings from reduced hospitalization and institutionalization.

Acknowledgments
Gerofit has been funded by the Veterans Health Affairs Office of Geriatrics and Extended Care Non-Institutional Long-Term Care Funding and Mentored Partnership Program, and the Veterans Health Affairs Office of Rural Health Rural Enterprise-Wide Initiative.

The authors thank Kim Birkett, MPH, for assistance in editing, references, and graphics and the staff at the Wytheville, Staunton, and Danville community-based outpatient clinics for their support.

Exercise increases endurance, muscle strength, and functional performance with corresponding gains in mobility, survival, and quality of life.¹ However, even with these benefits and improvements in clinical outcomes, only 15% of adults aged ≥ 65 years follow current guidelines for exercise.² Despite their prior military training, the majority of veterans do not meet physical activity recommendations.³ Time, travel, and support are common barriers to exercise participation and adherence—barriers that are further amplified among older adults.

The Veterans Health Administration (VHA) is recognized as a world leader in telehealth service development. Currently, 677,000 veterans have received telehealth services, which represents 12% of the 5.6 million veterans under VHA care.⁴ Clinical video telehealth (CVT) is widely used within the VHA system to deliver health care that otherwise would not be available to veterans. Veterans who have difficulty traveling to the nearest US Department of Veteran Affairs (VA) medical center (VAMC) can access CVT programs at a participating VHA community-based outpatient clinic (CBOC). The VA has more than 45 CVT programs, including programs for mental health, weight management, cardiology, and dermatology. Outside the VA, cardiac exercise rehabilitation provided by CVT has been shown to be as effective as center-based programs in improving cardiovascular risk factors and functional capacity.⁵ A VHA exercise program that leveraged CVT resources and was dedicated to older adults with a wide range of comorbid conditions would have a high impact on the health and well-being of older veterans.

Gerofit is a VHA clinical demonstration program of supervised center-based exercise for veterans aged ≥ 65 years. Developed at the Durham VAMC Geriatric Research, Education, and Clinical Center (GRECC) in North Carolina, it has demonstrated improved clinical outcomes, including physical function, mobility, quality of life, and survival.^6-10 The program offers veterans individualized exercise in a group setting that focuses on improving endurance, strength, and balance. The exercise prescription is based on the patient’s physical limitations as identified in a physical performance assessment.

With support from VHA Geriatric Extended Care (GEC) and the Office of Rural Health (ORH), Gerofit was implemented in 10 VAMCs across 8 VISNs. However, barriers such as travel time, distance, and transportation limit participation. Previously, we found that rural veterans lack access to exercise programs.^11,12 Although some do aerobic exercise (AEX), most do not do resistance training (RT), though they are willing to learn. Access to Gerofit for rural veterans is expanding with recent support from the ORH Enterprise Wide Initiative. Rural program expansion includes several different Gerofit initiatives, many involving CBOCs.

The Salem VAMC Gerofit program sought to adapt the facility-based assessment and exercise procedures into a self-reliant CVT class for its CBOCs. This article describes the development of the Salem VAMC Gerofit CVT program, hereafter referred to as Tele-Gerofit.

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Program Design

Gerofit was established in 1986 at the Durham GRECC as an exercise and health promotion program for veterans aged ≥ 65 years.¹³ Its goal is to prevent or improve functional decline from physical inactivity and age-related conditions. Gerofit targets the geriatric patient population and thus extends beyond cardiac and pulmonary rehabilitation or weight loss programs. The primary exclusion criteria are based on safety issues in the context of a group exercise setting of older adults and include oxygen dependency, unstable cardiac disease, and moderate-to-severe cognitive impairment.

To participate in Gerofit, veterans must be able to perform activities of daily living and self-manage an exercise prescription developed by the exercise instructor based on physical performance testing. These physical performance tests include measures that are independent predictors of disability, loss of independent living, and death, as well as surrogate measures of exercise capacity (eg, strength, endurance, balance).^14,15 A novel aspect of Gerofit is that the physical performance assessment is used not only to determine physical limitations, but also to individualize the exercise prescription based on the observed deficits in strength, endurance, or balance. These assessments are performed at initial enrollment; 3 months, 6 months, and 1 year later; and annually after that. Currently, the center-based Gerofit programs administer 5 items of the Senior Fitness Test: 6-minute walk, 10-meter walk (10-MWT), 30-second 1-arm curl, 30-second chair-stand test, and 8-foot up-and-go.¹⁵ The side-by-side, semitandem, and tandem standing balance tests from the short physical performance battery also are performed.¹⁶ In addition, participants complete a questionnaire that includes items from the physical functioning scale of the 12-Item Short Form Health Survey (SF-12).

After each assessment, the Gerofit exercise instructor reviews the results with the veteran and formulates an individualized exercise prescription along with goals for improvement. Veterans are encouraged to attend supervised center-based exercise sessions 3 times weekly. Classes are offered in a gym or fitness center at the VAMC or in leased space. Each patient uses a cue card that lists an exercise plan personalized for intensity and duration for aerobic exercise (AEX; eg, treadmill walking, stationary bicycling, arm ergometry), RT using dumbbells and weight equipment, and functional exercises for flexibility and balance. Some medical centers also offer yoga, tai chi, or dancing Gerofit classes.

For participants in the Durham Gerofit program, mortality decreased 25% over a decade (hazard ratio, 0.75; 95% CI, 0.61-0.91).⁹ A substudy that included the Psychological General Well-Being Index found that 81% of participants significantly increased their score after 1 year.⁷ Observed initial improvement in physical performance has been sustained over 5 years.^10,17 One-year results from the recent Gerofit expansion to 6 other VAMCs showed clinically and statistically significantly improved physical performance from baseline to 3-, 6-, and 12-month follow-up.¹⁸

Adaptation of Gerofit to CVT Delivery

Initial work. The Greater Los Angeles VAMC Gerofit program conducted a pilot CVT exercise class of 6 veterans at the rural Bakersfield CBOC in California.¹⁹ Each week, an exercise instructor broadcast a 60-minute exercise class that included warm-up, RT with bands, progressive balance training, and flexibility. Trained student volunteers from California State University in Bakersfield kinesiology program were on site at the Bakersfield CBOC to perform the assessments and aid in exercises during the CVT sessions. Despite the lack of AEX per se, veterans showed significant improvement in endurance as measured by an increase in the number of steps completed in 2 minutes at the 3-month assessment (P = .049). Although exercises were not delivered in a circuit format, the improved endurance supported the potential for cardiovascular benefit from RT in older adults.

This pilot project also demonstrated that key components of the Gerofit program could be delivered safely by telehealth with onsite supervision. The Miami VA Healthcare System also offers CVT Gerofit exercise classes broadcast to the rural Florida CBOCs of Key Largo and Homestead.¹¹ The exercise activities offered for the Miami CVT participants incorporate components of AEX (calisthenics) and RT (resistance bands). Veterans enjoyed the classes, and adherence was good. However, availability of staff and space are an ongoing challenge.

In Key Largo, 5 veterans participated before the CVT classes were placed on hold owing to the demands of other CVT programs and limited availability of the telehealth clinical technician (TCT). The Homestead CBOC continues to offer CVT Gerofit exercise classes and has 6 regular participants. Notably, the physical space at the Homestead CBOC is smaller than that at the Key Largo CBOC; the Homestead CBOC has adjusted by shifting to exercises performed while standing or sitting, ensuring participants’ safety and satisfaction.

The Baltimore, Maryland VAMC Gerofit program offers other innovative CVT exercise classes, including a tai chi class, and a class with exercise performed while sitting in a chair. Although the Baltimore VAMC CVT exercise classes do not have the scope of the center-based exercise prescriptions, they are unique in that they are broadcast not only to their affiliated CBOCs, but also other Gerofit programs in different VISNs.

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Salem VAMC Gerofit Program. The center-based Salem VAMC Gerofit program was established in July 2015. In fiscal year 2017, its dedicated exercise facility had more than 5,000 patient visits. Despite the program’s success, we prioritized establishing Tele-Gerofit because of the medical center’s rural location in southwest Virginia and the large number of veterans who receive care at CBOCs. Therefore, much as with the pilot CVT Gerofit classes in Los Angeles and Miami, the target setting was rural CBOCs. The goal for Salem VAMC Tele-Gerofit was to modify Gerofit delivery to the CVT format and a CBOC setting with minimal modification of the content and personnel requirements of both physical performance testing and exercise training procedures. 

Adjustments for CBOC Setting. The enrollment process for Tele-Gerofit is the same as that for the center-based program. To start, a veteran’s primary care provider reviews the list of eligibility criteria and, if the veteran qualifies, places a consult. A Gerofit team member then contacts the veteran by phone to describe the program and schedule an assessment. At the baseline physical performance assessment, American College of Sports Medicine guidelines on exercise participation, health screening, and exercise intensity are used to evaluate veterans and rank them by their cardiovascular risk.²⁰ All new program participants start with low-intensity exercise and gradually progress to recommended levels of exercise. Before starting an exercise class, participants are instructed on use of the 10-point rating of perceived exertion (RPE).

Each CBOC site is supplied with an RPE poster that is displayed for participants’ use. During a Tele-Gerofit class, the exercise instructor asks participants to periodically report their RPE. This class differs slightly from the center-based exercise sessions in which RPE is primarily assessed when a different exercise is introduced or the duration or intensity of an exercise is increased. The Gerofit instructor monitors exercise and treatment fidelity, but the onsite TCT observes for safety during class. The TCT also takes initial vital signs and sets up the room for the class. Emergency contacts and procedures are posted in each CBOC CVT room and are available to the center-based exercise instructor. Because the CBOCs are not inside medical facilities, some CBOC directors have asked that heart rate monitors be used as an extra safety precaution to ensure that high-risk participants do not exceed a heart rate limit that may be set by their cardiologists.

Modifications to Physical Performance Assessment. Physical performance testing had to be adapted to the small rooms available at the CBOCs. For measuring normal gait speed, the 10-MWT was replaced with the 4-meter walk test (4-MWT). The 4-MWT has excellent test–retest reliability with an intraclass correlation coefficient (ICC) of 0.93, but the discrepancy in gait speed between the 4-MWT and the 10-MWT is such that the tests cannot be used interchangeably.²¹ For measuring endurance, the 6-minute walk test was replaced with the 2-minute step test (2-MST). In older adults, the 2-MST has a moderate correlation with 6-minute walk distance (r = 0.36; P = .04) and high reliability (ICC, 0.90).^15,22 The 30-second 1-arm curl, the 30-second chair-stand test, and the 8-foot up-and-go test are performed without modification and require only dumbbells, a chair without wheels, and a stopwatch.

The exercise instructor at the Salem VAMC conducts physical performance testing by 2-way videoconferencing with the veteran in a room at the CBOC. The TCT at the CBOC assists by measuring and demarcating 4 meters on the floor and a designated height on the wall for knee elevation for 4-MWT and 2-MST, respectively. The TCT remains in the room during the assessment visit. Except for taking vital signs before and after the physical performance assessment, the TCT does not participate in the testing. To date, more than 20 physical performance assessments have been conducted without difficulty at Salem-affiliated CBOCs. The primary challenge has been scheduling the room with CVT equipment (ie, camera and screen) for the 30-minute individual assessment session, which occurs on a rolling basis as individuals are enrolled and followed.

After the assessment is completed, the exercise instructor reviews the results with the participant and provides feedback on areas in need of improvement. However, these education sessions can be lengthy and are best supported by giving the patient a personalized handout. A goal of Tele-Gerofit is to improve the education session by following up with a phone call to discuss material that is mailed to the veteran; this material includes the questionnaire used in the parent program.

Functional Circuit Exercise. In Tele-Gerofit, exercise training is delivered by CVT broadcast from the Salem VAMC to veterans in a room (equipped with steps, dumbbells, chairs, and bands) at the CBOC. This type of exercise training, which uses only mobile equipment and plyometric (weight-bearing) exercises, is referred to as functional exercise. The AEX includes marching in place, moving on and off a raised step, and body-weight exercises, while RT uses dumbbells, resistance bands, and plyometric exercises (Table 2). 

Progression of intensity is achieved by increasing the rate of stepping and the size of the steps (AEX) or the number of repetitions and the weight of the dumbbells or bands (RT). Each veteran exercises at an intensity level that is appropriate for his or her baseline limitations and medical conditions. The exercise instructor uses different forms of the same equipment (eg, heavier dumbbells, higher steps) to vary intensity among individuals while having them perform the same exercises as a group. The challenge is to adjust the pace of the AEX or the timing of the RT repetitions for individuals new to the class.

Delivery of exercise training in the form of circuits allows for a diverse exercise program in a setting with limited space. Circuit training is an exercise modality that consists of a series of different exercises, each usually completed in 30 to 60 seconds, with minimal rest between each type of exercise. Each Tele-Gerofit circuit has a mix of AEX and RT exercises performed for 3 minutes consecutively (Figure). 

The design of the circuit training can be adjusted based on the number of individuals in the class. Larger classes can be split into 2 groups that alternate between exercise sets, while smaller classes have 1 group performing the same exercise set and then rotating to either the AEX or RT set. Total exercise time to complete the circuit depends on the number of different exercises, number of repetitions, and the rest between repetitions and the different exercises. In this way, total exercise time can be made shorter or longer depending on the veteran’s capacity.

Frequency. Tele-Gerofit exercise classes are currently offered twice weekly and last about 1 hour, which includes warm-up (8-10 minutes), functional circuit training (40 minutes), and cooldown/stretching (8-10 minutes). A challenge for the exercise instructor is the need to provide ongoing clear instructions both to the class and to individuals as needed. As the exercise prescription for each patient is based on physical performance testing, the exercise instructor for the training must be familiar with the test results. Derivation of the exercise prescription in Tele-Gerofit follows the same process as center-based Gerofit.

Each patient is given an exercise prescription written to address any impairments noted in the different domains of the physical performance assessment, scored using age and sex percentiles. For instance, individuals scoring poorly on lower body strength are given specific lower body strengthening exercises. Participants are given an exercise program that guides them toward achieving recommended physical activity guidelines using their RPE to modulate each exercise. Duration and intensity of each type of planned exercise are formally discussed after initial and follow-up assessments. In addition, exercise training is informally progressed throughout the program. For Tele-Gerofit, instructors must design each class with the group in mind while being prepared for modifications and specific changes for individuals.

Discussion

Tele-Gerofit adapts the well-established center-based Gerofit program to be executed without an exercise facility while maintaining the content of the evidence-based procedures. Physical performance testing and exercise training were modified, adding elements necessary for CVT assessments and classes to be broadcast from the Salem VAMC to its affiliated CBOCs. Tele-Gerofit exercises are performed in a circuit style that allows a veteran or small structured groups of veterans to move among exercises and requires less space than traditional group exercise does. Safety and monitoring concerns are addressed with a safety procedure that includes emergency plans for each site, prescreening of enrolled participants, and monitoring of exercise intensity in accordance with national guidelines.¹ Similar to the center-based Gerofit program, the exercise prescription is tailored to each veteran’s physical limitations based on initial and ongoing assessment of physical performance. Tele-Gerofit physical performance testing fulfills the same need with only a few modifications using validated measures. Tele-Gerofit assessments are administered by CVT without the need for additional staff on site.

Adaptation of center-based Gerofit exercise classes to Tele-Gerofit is a major innovation. Use of a circuit exercise design was supported by findings in older adults that RT alone, when performed quickly with minimal rest between each set and exercise station, increases both aerobic capacity and strength.^23,24 Older adult RT trials that compared circuit RT with traditional RT found that strength gains are comparable between circuit and traditional RT.^24-26 Working with adults aged > 60 years, Takeshima and colleagues conducted a trial of circuit exercise with added callisthenic exercises performed in place between RT on exercise machines.²⁷ This dual-modality (AEX+RT) circuit approach was well tolerated and effective, increasing aerobic capacity and strength. Unfortunately, the resistance exercise machines used in those circuit exercise studies and in the center-based Gerofit program are not an option for Tele-Gerofit.

The requirement for an exercise facility was removed by designing Tele-Gerofit exercise to include only functional exercises that rely on body weight or small mobile exercise equipment. Although popular among young adults, functional circuit exercise is understudied in older adults. Recently, a 12-week functional circuit exercise intervention in frail elderly adults demonstrated significant improvements in gait speed and the timed chair-stand test.²⁸ A pilot observational study of Gerofit participants at the Canandaigua VAMC offered 27 veterans functional circuit exercise instead of their traditional exercise facility class and found larger increases in the timed chair-stand test and 6-minute walk distance compared with 11 Gerofit participants in the traditional program.²⁹

This Tele-Gerofit exercise training combines functional and circuit exercise strategies into telehealth delivery. However, its effect on physical performance remains to be demonstrated. To address this question, we are conducting a single-arm pilot study of Tele-Gerofit with CVT broadcast to 3 Salem CBOC affiliates (Wytheville, Staunton, and Danville, Virginia). The goal is to determine the effect on physical performance and collect feasibility data, including attendance rate and patient satisfaction with the video broadcast. In addition, we are planning an effectiveness trial to compare the impact of functional circuit exercise delivered in person (center based, not CVT) with the parent Gerofit exercise program on direct measures of endurance and strength, in addition to physical performance.

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Implementation research is needed to determine how Tele-Gerofit can be disseminated to other VAMCs and community-based centers beyond CBOCs. Although the cost of the equipment used to implement Tele-Gerofit is minimal, the program requires dedicated and experienced exercise instructors, and the sharing of telehealth resources with other clinical programs. The authors expect that a diverse group of stakeholders is needed across service lines of primary care, geriatrics and extended care, physical medicine and rehabilitation, and telehealth. Of note, this multidisciplinary collaboration is a hallmark of the Gerofit program. The recent success of the implementation of center-based Gerofit in VAMCs across the US demonstrates the program’s flexibility and robust results.¹⁸

Plans also include refining strategies for physical performance testing and exercise monitoring. For instance, we would like to adapt telehealth technology for heart rate monitors that can be worn by high-risk veterans at the CBOC and viewed in real time by the exercise instructor. Gerofit is currently being developed nationally for home use, which would remove the need to travel to a CBOC.

Conclusion

Gerofit, which is designed to help older veterans maintain independent living and prevent disability, has been demonstrated to improve quality of life and survival. Our goal has been to adapt Gerofit to CVT and provide a supervised, individualized exercise program in a group setting—a program that can be widely disseminated. Salem VAMC Tele-Gerofit is an innovative and prescriptive program that delivers CVT functional circuit exercise training to remote locations without the need for stationary exercise equipment. This approach has the potential to become an effective and feasible exercise strategy for preventing and minimizing disability in the increasing population of older veterans. Work is needed to determine whether Tele-Gerofit provides a rapid translation of Gerofit to clinical practice and improved outcomes with substantial cost savings from reduced hospitalization and institutionalization.

Acknowledgments
Gerofit has been funded by the Veterans Health Affairs Office of Geriatrics and Extended Care Non-Institutional Long-Term Care Funding and Mentored Partnership Program, and the Veterans Health Affairs Office of Rural Health Rural Enterprise-Wide Initiative.

The authors thank Kim Birkett, MPH, for assistance in editing, references, and graphics and the staff at the Wytheville, Staunton, and Danville community-based outpatient clinics for their support.