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Migraine treatment insights offered for noninvasive vagus nerve stimulation
SAN FRANCISCO – Now that noninvasive vagus nerve stimulation using a small handheld device has earned clearance from the Food and Drug Administration for acute treatment of migraine attacks, investigators are pouring over data from the major clinical trials to gain post hoc insight into how to optimize use of the gammaCore device in routine clinical practice.
The answer is to use it early in the course of an attack and use it often, Eric Liebler said at the annual meeting of the American Headache Society.
“Our motto here in the U.S. is to get the device and use it as many times as you want during the month. There are no pharmacologic side effects, no drug-drug interactions, and no risk of overusing it that we are aware of at this point. So if you give it to a patient who’s able to say, ‘Wait a second – I don’t feel good, I have premonitory symptoms,’ if they use it, then they’re likely to feel better, with a clinically relevant reduction of at least 1 point when treating a migraine while it’s mild,” according to Mr. Liebler, senior vice president for neurology at electroCore, of Basking Ridge, N.J., which markets the noninvasive vagus nerve stimulation (nVNS) gammaCore device.
The device received FDA clearance for acute treatment of migraine in January 2018 following regulatory approval in the spring of 2017 for treatment of episodic cluster headache.
Mr. Liebler presented key highlights of the recently published pivotal PRESTO trial (Prospective Study of nVNS for the Acute Treatment of Migraine), a randomized, double-blind, multicenter, sham-controlled study of 243 adults under age 50 years who experienced 3-8 migraine attacks per month (Neurology. 2018 Jun 15. doi: 10.1212/WNL.0000000000005857).
“This study provides Class I evidence that, for patients with an episodic migraine, nVNS significantly increases the probability of having mild pain or being pain-free post stimulation,” Mr. Liebler declared.
During the 4-week, double-blind treatment period, 48% of the active nVNS group met the International Headache Society definition of pain relief, which meant at least a 1-point reduction in migraine severity on a 0-3 point pain scale at 120 minutes in at least 50% of treated migraine episodes without using rescue medications. This was a significantly better result than the 32% rate seen in patients in the control group who were given a sham device that emitted a perceptible but ineffective signal.
Similar results were documented during the subsequent 4-week, open-label treatment period, during which the control group was switched over to a functioning gammaCore.
“You can tell your patients they have a reliable chance of having a response more often than not,” according to Mr. Liebler.
What else can physicians tell their migraine patients to expect regarding efficacy? The pain-free responder rate at 120 minutes in PRESTO and other studies is similar to rates reported in meta-analyses of oral triptan therapy but without any drug side effects or limitations on frequency of use. Furthermore, the need for rescue medication at any time during a migraine attack was significantly lower with nVNS than it was with sham treatment, by a margin of 48%-63%.
“If they use this device, they’re often able to save that triptan for when they wake up in the morning and they’re already at a 3 in migraine severity,” he observed.
Also, nVNS is fast-acting: At 30 minutes from onset of pain in the first treated attack, 27% of the nVNS group had experienced pain relief, compared with 19% of controls.
The tolerability profile of the device therapy was outstanding, with no treatment discontinuations in the active treatment arm and only occasional reports of mild transient application site discomfort.
Asked about insurance coverage, Mr. Liebler said broad coverage is coming, but it’s not here yet.
“Insurers don’t really want to pay for anything, and devices confuse them even more than drugs. But we’re getting there because of the quality of the evidence. They were really having a good time telling us we didn’t have any published papers, and now that we’ve given them a class I study published in Neurology, they’ve said they had to review it. CVS will cover it starting Jan. 1,” he continued.
Planning is underway for additional clinical trials of the gammaCore for prevention of episodic migraine, acute treatment of attacks in adolescents, and for use in pregnancy.
Using the nVNS device
This nVNS device produces a proprietary, low-voltage electrical signal with a 24-volt peak voltage and a 60-mA peak output current. In the PRESTO study, patients were instructed to self-administer bilateral 120-second stimulations to the right and left sides of their necks within 20 minutes of pain onset. If the pain hadn’t improved within 15 minutes, they were to repeat the stimulations.
In a post hoc analysis of the PREVA (Prevention and Acute treatment of chronic cluster headache) study (Cephalalgia. 2016;36[6]:534-46), investigators determined that the mean reduction in the number of cluster headache attacks was significantly greater in patients who used the device to treat at least 77% of their attacks. That had a bigger preventive effect than did the number of stimulations a patient applied per day.
The PRESTO and PREVA trials were sponsored by electroCore, where Mr. Liebler is employed.
SAN FRANCISCO – Now that noninvasive vagus nerve stimulation using a small handheld device has earned clearance from the Food and Drug Administration for acute treatment of migraine attacks, investigators are pouring over data from the major clinical trials to gain post hoc insight into how to optimize use of the gammaCore device in routine clinical practice.
The answer is to use it early in the course of an attack and use it often, Eric Liebler said at the annual meeting of the American Headache Society.
“Our motto here in the U.S. is to get the device and use it as many times as you want during the month. There are no pharmacologic side effects, no drug-drug interactions, and no risk of overusing it that we are aware of at this point. So if you give it to a patient who’s able to say, ‘Wait a second – I don’t feel good, I have premonitory symptoms,’ if they use it, then they’re likely to feel better, with a clinically relevant reduction of at least 1 point when treating a migraine while it’s mild,” according to Mr. Liebler, senior vice president for neurology at electroCore, of Basking Ridge, N.J., which markets the noninvasive vagus nerve stimulation (nVNS) gammaCore device.
The device received FDA clearance for acute treatment of migraine in January 2018 following regulatory approval in the spring of 2017 for treatment of episodic cluster headache.
Mr. Liebler presented key highlights of the recently published pivotal PRESTO trial (Prospective Study of nVNS for the Acute Treatment of Migraine), a randomized, double-blind, multicenter, sham-controlled study of 243 adults under age 50 years who experienced 3-8 migraine attacks per month (Neurology. 2018 Jun 15. doi: 10.1212/WNL.0000000000005857).
“This study provides Class I evidence that, for patients with an episodic migraine, nVNS significantly increases the probability of having mild pain or being pain-free post stimulation,” Mr. Liebler declared.
During the 4-week, double-blind treatment period, 48% of the active nVNS group met the International Headache Society definition of pain relief, which meant at least a 1-point reduction in migraine severity on a 0-3 point pain scale at 120 minutes in at least 50% of treated migraine episodes without using rescue medications. This was a significantly better result than the 32% rate seen in patients in the control group who were given a sham device that emitted a perceptible but ineffective signal.
Similar results were documented during the subsequent 4-week, open-label treatment period, during which the control group was switched over to a functioning gammaCore.
“You can tell your patients they have a reliable chance of having a response more often than not,” according to Mr. Liebler.
What else can physicians tell their migraine patients to expect regarding efficacy? The pain-free responder rate at 120 minutes in PRESTO and other studies is similar to rates reported in meta-analyses of oral triptan therapy but without any drug side effects or limitations on frequency of use. Furthermore, the need for rescue medication at any time during a migraine attack was significantly lower with nVNS than it was with sham treatment, by a margin of 48%-63%.
“If they use this device, they’re often able to save that triptan for when they wake up in the morning and they’re already at a 3 in migraine severity,” he observed.
Also, nVNS is fast-acting: At 30 minutes from onset of pain in the first treated attack, 27% of the nVNS group had experienced pain relief, compared with 19% of controls.
The tolerability profile of the device therapy was outstanding, with no treatment discontinuations in the active treatment arm and only occasional reports of mild transient application site discomfort.
Asked about insurance coverage, Mr. Liebler said broad coverage is coming, but it’s not here yet.
“Insurers don’t really want to pay for anything, and devices confuse them even more than drugs. But we’re getting there because of the quality of the evidence. They were really having a good time telling us we didn’t have any published papers, and now that we’ve given them a class I study published in Neurology, they’ve said they had to review it. CVS will cover it starting Jan. 1,” he continued.
Planning is underway for additional clinical trials of the gammaCore for prevention of episodic migraine, acute treatment of attacks in adolescents, and for use in pregnancy.
Using the nVNS device
This nVNS device produces a proprietary, low-voltage electrical signal with a 24-volt peak voltage and a 60-mA peak output current. In the PRESTO study, patients were instructed to self-administer bilateral 120-second stimulations to the right and left sides of their necks within 20 minutes of pain onset. If the pain hadn’t improved within 15 minutes, they were to repeat the stimulations.
In a post hoc analysis of the PREVA (Prevention and Acute treatment of chronic cluster headache) study (Cephalalgia. 2016;36[6]:534-46), investigators determined that the mean reduction in the number of cluster headache attacks was significantly greater in patients who used the device to treat at least 77% of their attacks. That had a bigger preventive effect than did the number of stimulations a patient applied per day.
The PRESTO and PREVA trials were sponsored by electroCore, where Mr. Liebler is employed.
SAN FRANCISCO – Now that noninvasive vagus nerve stimulation using a small handheld device has earned clearance from the Food and Drug Administration for acute treatment of migraine attacks, investigators are pouring over data from the major clinical trials to gain post hoc insight into how to optimize use of the gammaCore device in routine clinical practice.
The answer is to use it early in the course of an attack and use it often, Eric Liebler said at the annual meeting of the American Headache Society.
“Our motto here in the U.S. is to get the device and use it as many times as you want during the month. There are no pharmacologic side effects, no drug-drug interactions, and no risk of overusing it that we are aware of at this point. So if you give it to a patient who’s able to say, ‘Wait a second – I don’t feel good, I have premonitory symptoms,’ if they use it, then they’re likely to feel better, with a clinically relevant reduction of at least 1 point when treating a migraine while it’s mild,” according to Mr. Liebler, senior vice president for neurology at electroCore, of Basking Ridge, N.J., which markets the noninvasive vagus nerve stimulation (nVNS) gammaCore device.
The device received FDA clearance for acute treatment of migraine in January 2018 following regulatory approval in the spring of 2017 for treatment of episodic cluster headache.
Mr. Liebler presented key highlights of the recently published pivotal PRESTO trial (Prospective Study of nVNS for the Acute Treatment of Migraine), a randomized, double-blind, multicenter, sham-controlled study of 243 adults under age 50 years who experienced 3-8 migraine attacks per month (Neurology. 2018 Jun 15. doi: 10.1212/WNL.0000000000005857).
“This study provides Class I evidence that, for patients with an episodic migraine, nVNS significantly increases the probability of having mild pain or being pain-free post stimulation,” Mr. Liebler declared.
During the 4-week, double-blind treatment period, 48% of the active nVNS group met the International Headache Society definition of pain relief, which meant at least a 1-point reduction in migraine severity on a 0-3 point pain scale at 120 minutes in at least 50% of treated migraine episodes without using rescue medications. This was a significantly better result than the 32% rate seen in patients in the control group who were given a sham device that emitted a perceptible but ineffective signal.
Similar results were documented during the subsequent 4-week, open-label treatment period, during which the control group was switched over to a functioning gammaCore.
“You can tell your patients they have a reliable chance of having a response more often than not,” according to Mr. Liebler.
What else can physicians tell their migraine patients to expect regarding efficacy? The pain-free responder rate at 120 minutes in PRESTO and other studies is similar to rates reported in meta-analyses of oral triptan therapy but without any drug side effects or limitations on frequency of use. Furthermore, the need for rescue medication at any time during a migraine attack was significantly lower with nVNS than it was with sham treatment, by a margin of 48%-63%.
“If they use this device, they’re often able to save that triptan for when they wake up in the morning and they’re already at a 3 in migraine severity,” he observed.
Also, nVNS is fast-acting: At 30 minutes from onset of pain in the first treated attack, 27% of the nVNS group had experienced pain relief, compared with 19% of controls.
The tolerability profile of the device therapy was outstanding, with no treatment discontinuations in the active treatment arm and only occasional reports of mild transient application site discomfort.
Asked about insurance coverage, Mr. Liebler said broad coverage is coming, but it’s not here yet.
“Insurers don’t really want to pay for anything, and devices confuse them even more than drugs. But we’re getting there because of the quality of the evidence. They were really having a good time telling us we didn’t have any published papers, and now that we’ve given them a class I study published in Neurology, they’ve said they had to review it. CVS will cover it starting Jan. 1,” he continued.
Planning is underway for additional clinical trials of the gammaCore for prevention of episodic migraine, acute treatment of attacks in adolescents, and for use in pregnancy.
Using the nVNS device
This nVNS device produces a proprietary, low-voltage electrical signal with a 24-volt peak voltage and a 60-mA peak output current. In the PRESTO study, patients were instructed to self-administer bilateral 120-second stimulations to the right and left sides of their necks within 20 minutes of pain onset. If the pain hadn’t improved within 15 minutes, they were to repeat the stimulations.
In a post hoc analysis of the PREVA (Prevention and Acute treatment of chronic cluster headache) study (Cephalalgia. 2016;36[6]:534-46), investigators determined that the mean reduction in the number of cluster headache attacks was significantly greater in patients who used the device to treat at least 77% of their attacks. That had a bigger preventive effect than did the number of stimulations a patient applied per day.
The PRESTO and PREVA trials were sponsored by electroCore, where Mr. Liebler is employed.
EXPERT ANALYSIS FROM THE AHS ANNUAL MEETING
Device impresses for chronic cluster headache attacks
SAN FRANCISCO – Sphenopalatine ganglion stimulation using an implanted miniature neuromodulation device shows the potential to be a breakthrough nonpharmacologic therapy for acute episodes of chronic cluster headache based upon the results of the sham-controlled Pathway CH-2 study.
Self-administered sphenopalatine ganglion (SPG) stimulation using a wireless hand-held controller not only resulted in a 2.6-fold greater likelihood of providing pain relief within 15 minutes without resort to acute medications, compared with sham stimulation, but the device therapy also led to a significant reduction in cluster headache frequency over time, presumably through its neuromodulatory effects, David W. Dodick, MD, said in presenting the study results at the annual meeting of the American Headache Society.
An additional benefit of SPG stimulation was less need for triptans, with their many side effects. Patients in the active treatment arm of the 28-week sham-controlled portion of the multicenter prospective study used triptans for abortive therapy an average of 3.7 times less per week during the final 4 weeks of that period than they did during the 4-week baseline period, compared with a 1.2-dose per week reduction in the control group, noted Dr. Dodick, principal investigator for the Pathway CH-2 study and professor of neurology at the Mayo Clinic in Scottsdale, Ariz.
Cluster headache pain has been described as one of the most severe forms of pain known to humans. It is extremely disabling. Treatment options leave much to be desired, as detailed in a patient survey presented elsewhere during the meeting.
The 93 participants in the Pathway CH-2 study had a mean 8-year history of chronic cluster headaches. During the 4-week baseline assessment period, they averaged roughly 11 cluster attacks per week. All patients underwent surgical insertion of the miniature ATI Neurostimulator through a small incision in the upper gum. The device was placed deep in the face adjacent to the SPG nerve bundle. Patients were taught to activate the neurostimulator by placing a hand-held controller on the side of the face near the implanted device when a cluster headache attack struck. Participants were randomized to active treatment or sham stimulation, which delivered a mild electric current to the side of the face.
The primary efficacy endpoint was pain relief within 15 minutes of starting SPG stimulation without resort to abortive medications. Sixty-three percent of the SPG neurostimulation group and 29% of sham-treated controls achieved that goal for at least 50% of their headache attacks. Forty-six percent of SPG stimulators were able to attain pain relief within 15 minutes for 75% or more of their attacks. Fifty-seven percent of the active treatment group maintained pain relief at 60 minutes, compared with just 5% of controls.
“We’re used to thinking in terms of responder rates. Roughly half of patients using SPG stimulation had at least a 75% reduction in weekly cluster attacks, 46% of them had at least a 75% reduction in the severity of attacks, and 71% were super-responders, so to speak, with at least a 75% reduction in either attack frequency or severity,” according to Dr. Dodick.
The mean reduction in cluster attack frequency from baseline through 28 weeks was 6.8 fewer attacks per week in the active treatment group, significantly better than the mean 2.6-attack reduction in controls. At 1 year post implantation, the SPG stimulation group averaged 9.4 fewer cluster attacks per week than at baseline.
The ATI SPG Microstimulator System was well tolerated overall. Common treatment-related adverse events limited to the first 30 days after device implantation included numbness, swelling, pain, bruising, and paresthesia secondary to the surgical procedure. Given the discomfort inherent to gum surgery, “I was actually surprised there weren’t more adverse events,” Dr. Dodick said.
Four serious adverse events related to the device or its implantation occurred among the 93 participants: a venous injury, an infection, aspiration during intubation, and an instance of nausea and vomiting. All resolved without sequelae.
The ATI SPG Microstimulator System is investigational in the United States. The system is approved by European authorities for acute treatment of cluster headaches and refractory disabling migraine.
Patients speak out about shortcomings of cluster headache treatment
Elsewhere at the meeting, Emmanuelle Schindler, MD, PhD, a neurologist at Yale University in New Haven, Conn., reported on 493 participants in the Clusterbusters Medication Use Survey. The results provided a sobering picture of the shortcomings of current cluster headache treatments from the patient perspective.
Two-thirds of subjects had episodic cluster headache, while the remainder had the chronic form. Roughly 11% of subjects reported limiting adverse events caused by their abortive and/or preventive medications. A similar percentage reported resistance to all approved preventive drugs. Inconsistency of medication efficacy was a common theme. The survey respondents want novel treatments that are safe and effective. And they expressed a wish that more primary care physicians were well informed about cluster headaches; many of the individuals with cluster headache reported difficulty in reaching a knowledgeable headache specialist.
The Pathway CH-2 study was funded by Autonomic Technologies Inc. Dr. Dodick serves as a consultant to that company and numerous others. Dr. Schindler’s survey was funded by Clusterbusters, a nonprofit research organization.
SOURCE: Dodick DW, AHS 2018, Abstract PS112LB.
SAN FRANCISCO – Sphenopalatine ganglion stimulation using an implanted miniature neuromodulation device shows the potential to be a breakthrough nonpharmacologic therapy for acute episodes of chronic cluster headache based upon the results of the sham-controlled Pathway CH-2 study.
Self-administered sphenopalatine ganglion (SPG) stimulation using a wireless hand-held controller not only resulted in a 2.6-fold greater likelihood of providing pain relief within 15 minutes without resort to acute medications, compared with sham stimulation, but the device therapy also led to a significant reduction in cluster headache frequency over time, presumably through its neuromodulatory effects, David W. Dodick, MD, said in presenting the study results at the annual meeting of the American Headache Society.
An additional benefit of SPG stimulation was less need for triptans, with their many side effects. Patients in the active treatment arm of the 28-week sham-controlled portion of the multicenter prospective study used triptans for abortive therapy an average of 3.7 times less per week during the final 4 weeks of that period than they did during the 4-week baseline period, compared with a 1.2-dose per week reduction in the control group, noted Dr. Dodick, principal investigator for the Pathway CH-2 study and professor of neurology at the Mayo Clinic in Scottsdale, Ariz.
Cluster headache pain has been described as one of the most severe forms of pain known to humans. It is extremely disabling. Treatment options leave much to be desired, as detailed in a patient survey presented elsewhere during the meeting.
The 93 participants in the Pathway CH-2 study had a mean 8-year history of chronic cluster headaches. During the 4-week baseline assessment period, they averaged roughly 11 cluster attacks per week. All patients underwent surgical insertion of the miniature ATI Neurostimulator through a small incision in the upper gum. The device was placed deep in the face adjacent to the SPG nerve bundle. Patients were taught to activate the neurostimulator by placing a hand-held controller on the side of the face near the implanted device when a cluster headache attack struck. Participants were randomized to active treatment or sham stimulation, which delivered a mild electric current to the side of the face.
The primary efficacy endpoint was pain relief within 15 minutes of starting SPG stimulation without resort to abortive medications. Sixty-three percent of the SPG neurostimulation group and 29% of sham-treated controls achieved that goal for at least 50% of their headache attacks. Forty-six percent of SPG stimulators were able to attain pain relief within 15 minutes for 75% or more of their attacks. Fifty-seven percent of the active treatment group maintained pain relief at 60 minutes, compared with just 5% of controls.
“We’re used to thinking in terms of responder rates. Roughly half of patients using SPG stimulation had at least a 75% reduction in weekly cluster attacks, 46% of them had at least a 75% reduction in the severity of attacks, and 71% were super-responders, so to speak, with at least a 75% reduction in either attack frequency or severity,” according to Dr. Dodick.
The mean reduction in cluster attack frequency from baseline through 28 weeks was 6.8 fewer attacks per week in the active treatment group, significantly better than the mean 2.6-attack reduction in controls. At 1 year post implantation, the SPG stimulation group averaged 9.4 fewer cluster attacks per week than at baseline.
The ATI SPG Microstimulator System was well tolerated overall. Common treatment-related adverse events limited to the first 30 days after device implantation included numbness, swelling, pain, bruising, and paresthesia secondary to the surgical procedure. Given the discomfort inherent to gum surgery, “I was actually surprised there weren’t more adverse events,” Dr. Dodick said.
Four serious adverse events related to the device or its implantation occurred among the 93 participants: a venous injury, an infection, aspiration during intubation, and an instance of nausea and vomiting. All resolved without sequelae.
The ATI SPG Microstimulator System is investigational in the United States. The system is approved by European authorities for acute treatment of cluster headaches and refractory disabling migraine.
Patients speak out about shortcomings of cluster headache treatment
Elsewhere at the meeting, Emmanuelle Schindler, MD, PhD, a neurologist at Yale University in New Haven, Conn., reported on 493 participants in the Clusterbusters Medication Use Survey. The results provided a sobering picture of the shortcomings of current cluster headache treatments from the patient perspective.
Two-thirds of subjects had episodic cluster headache, while the remainder had the chronic form. Roughly 11% of subjects reported limiting adverse events caused by their abortive and/or preventive medications. A similar percentage reported resistance to all approved preventive drugs. Inconsistency of medication efficacy was a common theme. The survey respondents want novel treatments that are safe and effective. And they expressed a wish that more primary care physicians were well informed about cluster headaches; many of the individuals with cluster headache reported difficulty in reaching a knowledgeable headache specialist.
The Pathway CH-2 study was funded by Autonomic Technologies Inc. Dr. Dodick serves as a consultant to that company and numerous others. Dr. Schindler’s survey was funded by Clusterbusters, a nonprofit research organization.
SOURCE: Dodick DW, AHS 2018, Abstract PS112LB.
SAN FRANCISCO – Sphenopalatine ganglion stimulation using an implanted miniature neuromodulation device shows the potential to be a breakthrough nonpharmacologic therapy for acute episodes of chronic cluster headache based upon the results of the sham-controlled Pathway CH-2 study.
Self-administered sphenopalatine ganglion (SPG) stimulation using a wireless hand-held controller not only resulted in a 2.6-fold greater likelihood of providing pain relief within 15 minutes without resort to acute medications, compared with sham stimulation, but the device therapy also led to a significant reduction in cluster headache frequency over time, presumably through its neuromodulatory effects, David W. Dodick, MD, said in presenting the study results at the annual meeting of the American Headache Society.
An additional benefit of SPG stimulation was less need for triptans, with their many side effects. Patients in the active treatment arm of the 28-week sham-controlled portion of the multicenter prospective study used triptans for abortive therapy an average of 3.7 times less per week during the final 4 weeks of that period than they did during the 4-week baseline period, compared with a 1.2-dose per week reduction in the control group, noted Dr. Dodick, principal investigator for the Pathway CH-2 study and professor of neurology at the Mayo Clinic in Scottsdale, Ariz.
Cluster headache pain has been described as one of the most severe forms of pain known to humans. It is extremely disabling. Treatment options leave much to be desired, as detailed in a patient survey presented elsewhere during the meeting.
The 93 participants in the Pathway CH-2 study had a mean 8-year history of chronic cluster headaches. During the 4-week baseline assessment period, they averaged roughly 11 cluster attacks per week. All patients underwent surgical insertion of the miniature ATI Neurostimulator through a small incision in the upper gum. The device was placed deep in the face adjacent to the SPG nerve bundle. Patients were taught to activate the neurostimulator by placing a hand-held controller on the side of the face near the implanted device when a cluster headache attack struck. Participants were randomized to active treatment or sham stimulation, which delivered a mild electric current to the side of the face.
The primary efficacy endpoint was pain relief within 15 minutes of starting SPG stimulation without resort to abortive medications. Sixty-three percent of the SPG neurostimulation group and 29% of sham-treated controls achieved that goal for at least 50% of their headache attacks. Forty-six percent of SPG stimulators were able to attain pain relief within 15 minutes for 75% or more of their attacks. Fifty-seven percent of the active treatment group maintained pain relief at 60 minutes, compared with just 5% of controls.
“We’re used to thinking in terms of responder rates. Roughly half of patients using SPG stimulation had at least a 75% reduction in weekly cluster attacks, 46% of them had at least a 75% reduction in the severity of attacks, and 71% were super-responders, so to speak, with at least a 75% reduction in either attack frequency or severity,” according to Dr. Dodick.
The mean reduction in cluster attack frequency from baseline through 28 weeks was 6.8 fewer attacks per week in the active treatment group, significantly better than the mean 2.6-attack reduction in controls. At 1 year post implantation, the SPG stimulation group averaged 9.4 fewer cluster attacks per week than at baseline.
The ATI SPG Microstimulator System was well tolerated overall. Common treatment-related adverse events limited to the first 30 days after device implantation included numbness, swelling, pain, bruising, and paresthesia secondary to the surgical procedure. Given the discomfort inherent to gum surgery, “I was actually surprised there weren’t more adverse events,” Dr. Dodick said.
Four serious adverse events related to the device or its implantation occurred among the 93 participants: a venous injury, an infection, aspiration during intubation, and an instance of nausea and vomiting. All resolved without sequelae.
The ATI SPG Microstimulator System is investigational in the United States. The system is approved by European authorities for acute treatment of cluster headaches and refractory disabling migraine.
Patients speak out about shortcomings of cluster headache treatment
Elsewhere at the meeting, Emmanuelle Schindler, MD, PhD, a neurologist at Yale University in New Haven, Conn., reported on 493 participants in the Clusterbusters Medication Use Survey. The results provided a sobering picture of the shortcomings of current cluster headache treatments from the patient perspective.
Two-thirds of subjects had episodic cluster headache, while the remainder had the chronic form. Roughly 11% of subjects reported limiting adverse events caused by their abortive and/or preventive medications. A similar percentage reported resistance to all approved preventive drugs. Inconsistency of medication efficacy was a common theme. The survey respondents want novel treatments that are safe and effective. And they expressed a wish that more primary care physicians were well informed about cluster headaches; many of the individuals with cluster headache reported difficulty in reaching a knowledgeable headache specialist.
The Pathway CH-2 study was funded by Autonomic Technologies Inc. Dr. Dodick serves as a consultant to that company and numerous others. Dr. Schindler’s survey was funded by Clusterbusters, a nonprofit research organization.
SOURCE: Dodick DW, AHS 2018, Abstract PS112LB.
REPORTING FROM THE AHS ANNUAL MEETING
Key clinical point: Sphenopalatine ganglion stimulation aborts chronic cluster headache attacks and reduces their frequency.
Major finding: Seventy-one percent of patients with longstanding chronic cluster headaches achieved at least a 75% reduction in either attack frequency or severity by using a sphenopalatine ganglion stimulation device.
Study details: This was a prospective multicenter study in which 93 chronic cluster headache patients were randomized to sphenopalatine ganglion stimulation or sham stimulation.
Disclosures: The presenter serves as a consultant to Autonomic Technologies Inc., which funded the study, and numerous other companies.
Source: Dodick DW. AHS 2018 Abstract PS112LB.
OnabotulinumtoxinA crushes topiramate in chronic migraine PRO benefits
SAN FRANCISCO – The odds of at least a 50% reduction in headache days per month in chronic migraine patients 32 weeks after randomization to onabotulinumtoxinA for prophylaxis were 394% greater than with topiramate in the multicenter, open-label FORWARD trial, Andrew M. Blumenfeld, MD, reported at the annual meeting of the American Headache Society.
“Impressively, onabotulinumtoxinA showed a more favorable effect on depressive symptoms,” he added. “The overall results suggest that the beneficial effects of onabotulinumtoxinA on a range of PROs may lead to improved adherence.”
The FORWARD trial was a multicenter, open-label, prospective, 36-week study which randomized 282 adult chronic migraine patients to fixed-dose onabotulinumtoxinA at the approved dose of 155 U every 12 weeks or to topiramate (Topamax) titrated over the course of 12 weeks to the approved dose of 50-100 mg/day. However, after 12 weeks on topiramate, patients could elect to discontinue the drug and switch to onabotulinumtoxinA.
This was a trial designed to evaluate effectiveness, which Dr. Blumenfeld defined as the combination of efficacy plus treatment adherence. And treatment adherence with topiramate was poor: 63% of patients discontinued that medication, mainly because of adverse events or lack of efficacy, compared with just 7.9% of the onabotulinumtoxinA group.
The primary endpoint was the proportion of patients who achieved at least a 50% reduction in headache days per month beginning at week 32, compared with their rate during 4 weeks at baseline. Of 142 patients randomized to topiramate, 25 completed 36 weeks of therapy, and 17 of those 25 (68%) achieved at least a 50% reduction in headache days per month. That’s one way to look at it. The other is to examine effectiveness: 17 of 142 topiramate-treated patients (12%) met the primary endpoint. In contrast, 99 of 140 patients assigned to onabotulinumtoxinA completed treatment, and 56 of those 99 (57%) met the primary endpoint. Thus, the neurotoxin therapy had a 40% effectiveness rate. The odds of being at least a 50% responder were 394% greater in the onabotulinumtoxinA group, according to Dr. Blumenfeld.
Secondary endpoints consisted of four PROs: the Headache Impact Test of migraine-related disability (HIT-6), the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), the Patient Health Questionnaire–9 (PHQ-9), and a cutting edge, not yet fully validated instrument known as the Functional Impact of Migraine Questionnaire, or FIMQ.
The onabotulinumtoxinA group fared significantly better than the topiramate group on all four PROs. But Dr. Blumenfeld singled out the PHQ-9 results as of particular clinical importance. A score of 5 or more is considered evidence of at least mild depression; on average, both groups were depressed at baseline, with a mean score of 6.5 in the onabotulinumtoxinA group and 7.6 in the topiramate group. At week 12, the scores were 5.2 and 6.7, respectively. At week 24, 4.5 versus 7.2. At week 36, the average PHQ-9 score in the onabotulinumtoxinA group was 4.4 – meaning no depression – compared with 7.1 in the topiramate group.
A reduction in HIT-6 scores of more than 2.5 points is considered to represent clinically significant improvement in migraine-related disability. At week 6, the HIT-6 score had fallen by an average of 4.0 points from baseline in the onabotulinumtoxinA group, compared with –2.2 points with topiramate. At week 18, the margin of improvement was –5.1 versus –1.6 points, while at week 36 the average improvement was –5.6 points in the onabotulinumtoxinA group, compared with –1.4 points in the topiramate arm in a last-observation-carried-forward analysis.
Mean baseline scores on the WPAI-SHP were 4.8 in the onabotulinumtoxinA group and 5.1 in those on topiramate. At week 12, the scores had improved to 3.3 and 4.4, respectively, and at week 36, to 3.5 and 4.4, respectively, a significant and clinically meaningful difference.
Mean baseline scores on the FIMQ were 59.8 and 53.9 in the onabotulinumtoxinA and topiramate groups. By week 30, the scores were 37.1 and 47.5, respectively.
The main reasons half of the topiramate patients discontinued were the adverse events classically associated with the drug: paresthesia, cognitive impairment, nausea, and fatigue. None of these were reported by more than 0.5% of onabotulinumtoxinA recipients.
This is not the first study to show superior outcomes with neurotoxin therapy for the prevention of chronic migraine.
“There is a disconnect between the published data and what happens in the community,” Dr. Blumenfeld observed. “In clinical practice, topiramate is listed as first-line therapy for chronic migraine, while onabotulinumtoxinA is third or fourth line.”
Insurers normally balk at covering neurotoxin therapy because it is relatively expensive. But in an era when PROs have taken on new weight with regulatory agencies and payers, the ground may be soon be shifting.
One audience member noted that in the relatively small subgroup of patients who could tolerate topiramate sufficiently to stay on the drug, the outcomes were quite good. Dr. Blumenfeld concurred.
“It’s something that we all see in clinical practice: Those patients who can stay on topiramate, who can tolerate it, do very well. So for the 17 of 25 who stayed on it and had a 50% reduction in headache days, that 68% is a good number, and I think it matches our clinical experience,” he said. “But the key message of this study – and I think this is a different way of looking at the way we assess medications – is to look at efficacy, but also at tolerability and long-term adherence. And the problem with topiramate-treated patients, particularly in chronic migraine, is they have a difficult time staying on the medication long enough to see that good effect.”
The FORWARD trial was sponsored by Allergan. Dr. Blumenfeld serves as a consultant to that company and a half-dozen others.
SOURCE: Blumenfeld AM et al. Headache. 2018 Jun;58(52):75. Abstract IOR06.
SAN FRANCISCO – The odds of at least a 50% reduction in headache days per month in chronic migraine patients 32 weeks after randomization to onabotulinumtoxinA for prophylaxis were 394% greater than with topiramate in the multicenter, open-label FORWARD trial, Andrew M. Blumenfeld, MD, reported at the annual meeting of the American Headache Society.
“Impressively, onabotulinumtoxinA showed a more favorable effect on depressive symptoms,” he added. “The overall results suggest that the beneficial effects of onabotulinumtoxinA on a range of PROs may lead to improved adherence.”
The FORWARD trial was a multicenter, open-label, prospective, 36-week study which randomized 282 adult chronic migraine patients to fixed-dose onabotulinumtoxinA at the approved dose of 155 U every 12 weeks or to topiramate (Topamax) titrated over the course of 12 weeks to the approved dose of 50-100 mg/day. However, after 12 weeks on topiramate, patients could elect to discontinue the drug and switch to onabotulinumtoxinA.
This was a trial designed to evaluate effectiveness, which Dr. Blumenfeld defined as the combination of efficacy plus treatment adherence. And treatment adherence with topiramate was poor: 63% of patients discontinued that medication, mainly because of adverse events or lack of efficacy, compared with just 7.9% of the onabotulinumtoxinA group.
The primary endpoint was the proportion of patients who achieved at least a 50% reduction in headache days per month beginning at week 32, compared with their rate during 4 weeks at baseline. Of 142 patients randomized to topiramate, 25 completed 36 weeks of therapy, and 17 of those 25 (68%) achieved at least a 50% reduction in headache days per month. That’s one way to look at it. The other is to examine effectiveness: 17 of 142 topiramate-treated patients (12%) met the primary endpoint. In contrast, 99 of 140 patients assigned to onabotulinumtoxinA completed treatment, and 56 of those 99 (57%) met the primary endpoint. Thus, the neurotoxin therapy had a 40% effectiveness rate. The odds of being at least a 50% responder were 394% greater in the onabotulinumtoxinA group, according to Dr. Blumenfeld.
Secondary endpoints consisted of four PROs: the Headache Impact Test of migraine-related disability (HIT-6), the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), the Patient Health Questionnaire–9 (PHQ-9), and a cutting edge, not yet fully validated instrument known as the Functional Impact of Migraine Questionnaire, or FIMQ.
The onabotulinumtoxinA group fared significantly better than the topiramate group on all four PROs. But Dr. Blumenfeld singled out the PHQ-9 results as of particular clinical importance. A score of 5 or more is considered evidence of at least mild depression; on average, both groups were depressed at baseline, with a mean score of 6.5 in the onabotulinumtoxinA group and 7.6 in the topiramate group. At week 12, the scores were 5.2 and 6.7, respectively. At week 24, 4.5 versus 7.2. At week 36, the average PHQ-9 score in the onabotulinumtoxinA group was 4.4 – meaning no depression – compared with 7.1 in the topiramate group.
A reduction in HIT-6 scores of more than 2.5 points is considered to represent clinically significant improvement in migraine-related disability. At week 6, the HIT-6 score had fallen by an average of 4.0 points from baseline in the onabotulinumtoxinA group, compared with –2.2 points with topiramate. At week 18, the margin of improvement was –5.1 versus –1.6 points, while at week 36 the average improvement was –5.6 points in the onabotulinumtoxinA group, compared with –1.4 points in the topiramate arm in a last-observation-carried-forward analysis.
Mean baseline scores on the WPAI-SHP were 4.8 in the onabotulinumtoxinA group and 5.1 in those on topiramate. At week 12, the scores had improved to 3.3 and 4.4, respectively, and at week 36, to 3.5 and 4.4, respectively, a significant and clinically meaningful difference.
Mean baseline scores on the FIMQ were 59.8 and 53.9 in the onabotulinumtoxinA and topiramate groups. By week 30, the scores were 37.1 and 47.5, respectively.
The main reasons half of the topiramate patients discontinued were the adverse events classically associated with the drug: paresthesia, cognitive impairment, nausea, and fatigue. None of these were reported by more than 0.5% of onabotulinumtoxinA recipients.
This is not the first study to show superior outcomes with neurotoxin therapy for the prevention of chronic migraine.
“There is a disconnect between the published data and what happens in the community,” Dr. Blumenfeld observed. “In clinical practice, topiramate is listed as first-line therapy for chronic migraine, while onabotulinumtoxinA is third or fourth line.”
Insurers normally balk at covering neurotoxin therapy because it is relatively expensive. But in an era when PROs have taken on new weight with regulatory agencies and payers, the ground may be soon be shifting.
One audience member noted that in the relatively small subgroup of patients who could tolerate topiramate sufficiently to stay on the drug, the outcomes were quite good. Dr. Blumenfeld concurred.
“It’s something that we all see in clinical practice: Those patients who can stay on topiramate, who can tolerate it, do very well. So for the 17 of 25 who stayed on it and had a 50% reduction in headache days, that 68% is a good number, and I think it matches our clinical experience,” he said. “But the key message of this study – and I think this is a different way of looking at the way we assess medications – is to look at efficacy, but also at tolerability and long-term adherence. And the problem with topiramate-treated patients, particularly in chronic migraine, is they have a difficult time staying on the medication long enough to see that good effect.”
The FORWARD trial was sponsored by Allergan. Dr. Blumenfeld serves as a consultant to that company and a half-dozen others.
SOURCE: Blumenfeld AM et al. Headache. 2018 Jun;58(52):75. Abstract IOR06.
SAN FRANCISCO – The odds of at least a 50% reduction in headache days per month in chronic migraine patients 32 weeks after randomization to onabotulinumtoxinA for prophylaxis were 394% greater than with topiramate in the multicenter, open-label FORWARD trial, Andrew M. Blumenfeld, MD, reported at the annual meeting of the American Headache Society.
“Impressively, onabotulinumtoxinA showed a more favorable effect on depressive symptoms,” he added. “The overall results suggest that the beneficial effects of onabotulinumtoxinA on a range of PROs may lead to improved adherence.”
The FORWARD trial was a multicenter, open-label, prospective, 36-week study which randomized 282 adult chronic migraine patients to fixed-dose onabotulinumtoxinA at the approved dose of 155 U every 12 weeks or to topiramate (Topamax) titrated over the course of 12 weeks to the approved dose of 50-100 mg/day. However, after 12 weeks on topiramate, patients could elect to discontinue the drug and switch to onabotulinumtoxinA.
This was a trial designed to evaluate effectiveness, which Dr. Blumenfeld defined as the combination of efficacy plus treatment adherence. And treatment adherence with topiramate was poor: 63% of patients discontinued that medication, mainly because of adverse events or lack of efficacy, compared with just 7.9% of the onabotulinumtoxinA group.
The primary endpoint was the proportion of patients who achieved at least a 50% reduction in headache days per month beginning at week 32, compared with their rate during 4 weeks at baseline. Of 142 patients randomized to topiramate, 25 completed 36 weeks of therapy, and 17 of those 25 (68%) achieved at least a 50% reduction in headache days per month. That’s one way to look at it. The other is to examine effectiveness: 17 of 142 topiramate-treated patients (12%) met the primary endpoint. In contrast, 99 of 140 patients assigned to onabotulinumtoxinA completed treatment, and 56 of those 99 (57%) met the primary endpoint. Thus, the neurotoxin therapy had a 40% effectiveness rate. The odds of being at least a 50% responder were 394% greater in the onabotulinumtoxinA group, according to Dr. Blumenfeld.
Secondary endpoints consisted of four PROs: the Headache Impact Test of migraine-related disability (HIT-6), the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), the Patient Health Questionnaire–9 (PHQ-9), and a cutting edge, not yet fully validated instrument known as the Functional Impact of Migraine Questionnaire, or FIMQ.
The onabotulinumtoxinA group fared significantly better than the topiramate group on all four PROs. But Dr. Blumenfeld singled out the PHQ-9 results as of particular clinical importance. A score of 5 or more is considered evidence of at least mild depression; on average, both groups were depressed at baseline, with a mean score of 6.5 in the onabotulinumtoxinA group and 7.6 in the topiramate group. At week 12, the scores were 5.2 and 6.7, respectively. At week 24, 4.5 versus 7.2. At week 36, the average PHQ-9 score in the onabotulinumtoxinA group was 4.4 – meaning no depression – compared with 7.1 in the topiramate group.
A reduction in HIT-6 scores of more than 2.5 points is considered to represent clinically significant improvement in migraine-related disability. At week 6, the HIT-6 score had fallen by an average of 4.0 points from baseline in the onabotulinumtoxinA group, compared with –2.2 points with topiramate. At week 18, the margin of improvement was –5.1 versus –1.6 points, while at week 36 the average improvement was –5.6 points in the onabotulinumtoxinA group, compared with –1.4 points in the topiramate arm in a last-observation-carried-forward analysis.
Mean baseline scores on the WPAI-SHP were 4.8 in the onabotulinumtoxinA group and 5.1 in those on topiramate. At week 12, the scores had improved to 3.3 and 4.4, respectively, and at week 36, to 3.5 and 4.4, respectively, a significant and clinically meaningful difference.
Mean baseline scores on the FIMQ were 59.8 and 53.9 in the onabotulinumtoxinA and topiramate groups. By week 30, the scores were 37.1 and 47.5, respectively.
The main reasons half of the topiramate patients discontinued were the adverse events classically associated with the drug: paresthesia, cognitive impairment, nausea, and fatigue. None of these were reported by more than 0.5% of onabotulinumtoxinA recipients.
This is not the first study to show superior outcomes with neurotoxin therapy for the prevention of chronic migraine.
“There is a disconnect between the published data and what happens in the community,” Dr. Blumenfeld observed. “In clinical practice, topiramate is listed as first-line therapy for chronic migraine, while onabotulinumtoxinA is third or fourth line.”
Insurers normally balk at covering neurotoxin therapy because it is relatively expensive. But in an era when PROs have taken on new weight with regulatory agencies and payers, the ground may be soon be shifting.
One audience member noted that in the relatively small subgroup of patients who could tolerate topiramate sufficiently to stay on the drug, the outcomes were quite good. Dr. Blumenfeld concurred.
“It’s something that we all see in clinical practice: Those patients who can stay on topiramate, who can tolerate it, do very well. So for the 17 of 25 who stayed on it and had a 50% reduction in headache days, that 68% is a good number, and I think it matches our clinical experience,” he said. “But the key message of this study – and I think this is a different way of looking at the way we assess medications – is to look at efficacy, but also at tolerability and long-term adherence. And the problem with topiramate-treated patients, particularly in chronic migraine, is they have a difficult time staying on the medication long enough to see that good effect.”
The FORWARD trial was sponsored by Allergan. Dr. Blumenfeld serves as a consultant to that company and a half-dozen others.
SOURCE: Blumenfeld AM et al. Headache. 2018 Jun;58(52):75. Abstract IOR06.
REPORTING FROM THE AHS ANNUAL MEETING
Key clinical point:
Major finding: The likelihood of at least a 50% reduction in headache days per month in chronic migraine patients during weeks 29-32 versus baseline was nearly 400% greater in those randomized to onabotulinumtoxinA than to topiramate.
Study details: The FORWARD trial was a randomized, multicenter, open-label, 36-week study in 282 chronic migraine patients.
Disclosures: FORWARD was sponsored by Allergan. The presenter serves as a consultant to that company and a half-dozen others.
Source: Blumenfeld AM et al. Headache. 2018 Jun;58(52):75. Abstract IOR06.
Study busts three migraine trigger myths
SAN FRANCISCO – Half of migraineurs suspect chocolate can trigger their migraine attacks, but new evidence from a large prospective study suggests almost 99% of them are mistaken.
Additional analyses of this same dataset of 774 individuals with migraine threw cold water on two other widely accepted putative migraine triggers: neck pain/tension and dietary nitrate intake, Stephen Donoghue, PhD, reported at the annual meeting of the American Headache Society.
He presented a series of statistical analyses of often-cited migraine attack triggers conducted in 774 migraineurs who registered to use N1–Headache, a sophisticated proprietary digital headache diary. At the outset, participants rated on a 0-10 scale how strongly they suspected chocolate, neck pain or tension, and other factors acted as triggers for migraine attacks in their own personal experience. They then spent 2-3 minutes daily tracking more than 70 migraine-related elements for at least 90 days, recording the data using an iPhone or iPad rather than using a traditional, more hit-or-miss conventional paper diary.
The N1–Headache software, developed by Curelator of Cambridge, Mass., then tackled the key issue of what proportion of individuals who suspected a given trigger actually showed a statistically significant association prospectively between an individual’s day-to-day variations in experiencing that trigger and their headache risk, explained Dr. Donoghue, vice president for clinical development for Curelator.
Chocolate
The Curelator concept involves bringing personalized medicine to headache patients by identifying their true migraine attack triggers, which can enable individuals to deal with those triggers without the disruption involved in unnecessarily avoiding numerous nontriggers or missing real triggers.
The study results punctured some widely held beliefs. For example, at baseline 51% of migraineurs indicated they suspected chocolate served to some degree as a trigger for their own migraine attacks; the majority of them rated their suspicion as moderate or strong. However, in individually determined correlations, chocolate was indeed associated with migraine attacks in only 1.3% of those who suspected it to be a trigger. Moreover, in an another 3.9% of chocolate suspecters, chocolate consumption was actually associated with decreased risk; in other words, for them, chocolate appeared to serve as a protector against migraine, despite their preconceptions.
Also, among the 49% of participants who didn’t consider chocolate to be a personal migraine attack trigger, the Curelator analysis demonstrated that chocolate consumption was associated with a significantly increased risk of migraine attack in 2.2%, and a significantly lower risk of migraine in another 1.5%.
Neck pain/tension
Eighty percent of migraineurs who registered to use N1–Headache via the company’s website or the App Store indicated they believed neck pain/tension to be a migraine trigger for them; 46% rated it as a strong trigger. The detailed analysis of 90 days’ worth of data showed that 32% of participants with adequate data showed a statistically significant association between neck pain/tension and migraine headache.
The strength of an individual’s suspicion of neck paint/tension as a trigger was associated with the frequency of a statistically confirmed association. However, unlike for chocolate, there were zero instances where neck pain/tension was associated with protection against migraine.
In a twist, when the investigators reanalyzed their data after eliminating those instances where neck pain/tension occurred 1 day before the start of the headache, the association disappeared.
“The temporal association that we find using the lag-day analysis strongly suggests that neck pain/tension is part of the symptomatology of migraine attacks rather than acting as a trigger,” Dr. Donoghue observed.
This concept is strongly supported by a recent German study that used neck muscle electromyography to establish the same point (J Headache Pain. 2018 Mar 20;19[1]:26), he added.
Dr. Donoghue offered one caveat regarding the Curelator analyses: “We can’t say whether or not neck pain/tension and these other factors are actually triggers. What we’re looking at is associations. We’re not showing causality.”
Nitrates in food
Of the participants in this Curelator study, 45% suspected nitrate intake was a trigger for their migraine attacks, including 24% who rated the strength of their suspicion as moderate or severe. Of those who suspected nitrates, Cox proportional hazards modeling identified 2.2% in whom a significant association between nitrate consumption and increased migraine attack risk was present and another 1.1% in whom nitrates were associated with decreased risk, which suggests that they act as a possible protector in some cases. An individual’s strength of suspicion regarding nitrates proved unrelated to the actual risk of an association.
In subjects who did not suspect nitrates as a migraine trigger, Dr. Donoghue and colleagues identified 3.5% in whom nitrate intake was actually statistically associated with increased risk and 1.7% in whom it was linked to decreased risk.
The study was funded by Curelator, where Dr. Donoghue is employed.
SOURCE: Donoghue S et al. Headache. 2018 Jun;58(52):104,109,110.
SAN FRANCISCO – Half of migraineurs suspect chocolate can trigger their migraine attacks, but new evidence from a large prospective study suggests almost 99% of them are mistaken.
Additional analyses of this same dataset of 774 individuals with migraine threw cold water on two other widely accepted putative migraine triggers: neck pain/tension and dietary nitrate intake, Stephen Donoghue, PhD, reported at the annual meeting of the American Headache Society.
He presented a series of statistical analyses of often-cited migraine attack triggers conducted in 774 migraineurs who registered to use N1–Headache, a sophisticated proprietary digital headache diary. At the outset, participants rated on a 0-10 scale how strongly they suspected chocolate, neck pain or tension, and other factors acted as triggers for migraine attacks in their own personal experience. They then spent 2-3 minutes daily tracking more than 70 migraine-related elements for at least 90 days, recording the data using an iPhone or iPad rather than using a traditional, more hit-or-miss conventional paper diary.
The N1–Headache software, developed by Curelator of Cambridge, Mass., then tackled the key issue of what proportion of individuals who suspected a given trigger actually showed a statistically significant association prospectively between an individual’s day-to-day variations in experiencing that trigger and their headache risk, explained Dr. Donoghue, vice president for clinical development for Curelator.
Chocolate
The Curelator concept involves bringing personalized medicine to headache patients by identifying their true migraine attack triggers, which can enable individuals to deal with those triggers without the disruption involved in unnecessarily avoiding numerous nontriggers or missing real triggers.
The study results punctured some widely held beliefs. For example, at baseline 51% of migraineurs indicated they suspected chocolate served to some degree as a trigger for their own migraine attacks; the majority of them rated their suspicion as moderate or strong. However, in individually determined correlations, chocolate was indeed associated with migraine attacks in only 1.3% of those who suspected it to be a trigger. Moreover, in an another 3.9% of chocolate suspecters, chocolate consumption was actually associated with decreased risk; in other words, for them, chocolate appeared to serve as a protector against migraine, despite their preconceptions.
Also, among the 49% of participants who didn’t consider chocolate to be a personal migraine attack trigger, the Curelator analysis demonstrated that chocolate consumption was associated with a significantly increased risk of migraine attack in 2.2%, and a significantly lower risk of migraine in another 1.5%.
Neck pain/tension
Eighty percent of migraineurs who registered to use N1–Headache via the company’s website or the App Store indicated they believed neck pain/tension to be a migraine trigger for them; 46% rated it as a strong trigger. The detailed analysis of 90 days’ worth of data showed that 32% of participants with adequate data showed a statistically significant association between neck pain/tension and migraine headache.
The strength of an individual’s suspicion of neck paint/tension as a trigger was associated with the frequency of a statistically confirmed association. However, unlike for chocolate, there were zero instances where neck pain/tension was associated with protection against migraine.
In a twist, when the investigators reanalyzed their data after eliminating those instances where neck pain/tension occurred 1 day before the start of the headache, the association disappeared.
“The temporal association that we find using the lag-day analysis strongly suggests that neck pain/tension is part of the symptomatology of migraine attacks rather than acting as a trigger,” Dr. Donoghue observed.
This concept is strongly supported by a recent German study that used neck muscle electromyography to establish the same point (J Headache Pain. 2018 Mar 20;19[1]:26), he added.
Dr. Donoghue offered one caveat regarding the Curelator analyses: “We can’t say whether or not neck pain/tension and these other factors are actually triggers. What we’re looking at is associations. We’re not showing causality.”
Nitrates in food
Of the participants in this Curelator study, 45% suspected nitrate intake was a trigger for their migraine attacks, including 24% who rated the strength of their suspicion as moderate or severe. Of those who suspected nitrates, Cox proportional hazards modeling identified 2.2% in whom a significant association between nitrate consumption and increased migraine attack risk was present and another 1.1% in whom nitrates were associated with decreased risk, which suggests that they act as a possible protector in some cases. An individual’s strength of suspicion regarding nitrates proved unrelated to the actual risk of an association.
In subjects who did not suspect nitrates as a migraine trigger, Dr. Donoghue and colleagues identified 3.5% in whom nitrate intake was actually statistically associated with increased risk and 1.7% in whom it was linked to decreased risk.
The study was funded by Curelator, where Dr. Donoghue is employed.
SOURCE: Donoghue S et al. Headache. 2018 Jun;58(52):104,109,110.
SAN FRANCISCO – Half of migraineurs suspect chocolate can trigger their migraine attacks, but new evidence from a large prospective study suggests almost 99% of them are mistaken.
Additional analyses of this same dataset of 774 individuals with migraine threw cold water on two other widely accepted putative migraine triggers: neck pain/tension and dietary nitrate intake, Stephen Donoghue, PhD, reported at the annual meeting of the American Headache Society.
He presented a series of statistical analyses of often-cited migraine attack triggers conducted in 774 migraineurs who registered to use N1–Headache, a sophisticated proprietary digital headache diary. At the outset, participants rated on a 0-10 scale how strongly they suspected chocolate, neck pain or tension, and other factors acted as triggers for migraine attacks in their own personal experience. They then spent 2-3 minutes daily tracking more than 70 migraine-related elements for at least 90 days, recording the data using an iPhone or iPad rather than using a traditional, more hit-or-miss conventional paper diary.
The N1–Headache software, developed by Curelator of Cambridge, Mass., then tackled the key issue of what proportion of individuals who suspected a given trigger actually showed a statistically significant association prospectively between an individual’s day-to-day variations in experiencing that trigger and their headache risk, explained Dr. Donoghue, vice president for clinical development for Curelator.
Chocolate
The Curelator concept involves bringing personalized medicine to headache patients by identifying their true migraine attack triggers, which can enable individuals to deal with those triggers without the disruption involved in unnecessarily avoiding numerous nontriggers or missing real triggers.
The study results punctured some widely held beliefs. For example, at baseline 51% of migraineurs indicated they suspected chocolate served to some degree as a trigger for their own migraine attacks; the majority of them rated their suspicion as moderate or strong. However, in individually determined correlations, chocolate was indeed associated with migraine attacks in only 1.3% of those who suspected it to be a trigger. Moreover, in an another 3.9% of chocolate suspecters, chocolate consumption was actually associated with decreased risk; in other words, for them, chocolate appeared to serve as a protector against migraine, despite their preconceptions.
Also, among the 49% of participants who didn’t consider chocolate to be a personal migraine attack trigger, the Curelator analysis demonstrated that chocolate consumption was associated with a significantly increased risk of migraine attack in 2.2%, and a significantly lower risk of migraine in another 1.5%.
Neck pain/tension
Eighty percent of migraineurs who registered to use N1–Headache via the company’s website or the App Store indicated they believed neck pain/tension to be a migraine trigger for them; 46% rated it as a strong trigger. The detailed analysis of 90 days’ worth of data showed that 32% of participants with adequate data showed a statistically significant association between neck pain/tension and migraine headache.
The strength of an individual’s suspicion of neck paint/tension as a trigger was associated with the frequency of a statistically confirmed association. However, unlike for chocolate, there were zero instances where neck pain/tension was associated with protection against migraine.
In a twist, when the investigators reanalyzed their data after eliminating those instances where neck pain/tension occurred 1 day before the start of the headache, the association disappeared.
“The temporal association that we find using the lag-day analysis strongly suggests that neck pain/tension is part of the symptomatology of migraine attacks rather than acting as a trigger,” Dr. Donoghue observed.
This concept is strongly supported by a recent German study that used neck muscle electromyography to establish the same point (J Headache Pain. 2018 Mar 20;19[1]:26), he added.
Dr. Donoghue offered one caveat regarding the Curelator analyses: “We can’t say whether or not neck pain/tension and these other factors are actually triggers. What we’re looking at is associations. We’re not showing causality.”
Nitrates in food
Of the participants in this Curelator study, 45% suspected nitrate intake was a trigger for their migraine attacks, including 24% who rated the strength of their suspicion as moderate or severe. Of those who suspected nitrates, Cox proportional hazards modeling identified 2.2% in whom a significant association between nitrate consumption and increased migraine attack risk was present and another 1.1% in whom nitrates were associated with decreased risk, which suggests that they act as a possible protector in some cases. An individual’s strength of suspicion regarding nitrates proved unrelated to the actual risk of an association.
In subjects who did not suspect nitrates as a migraine trigger, Dr. Donoghue and colleagues identified 3.5% in whom nitrate intake was actually statistically associated with increased risk and 1.7% in whom it was linked to decreased risk.
The study was funded by Curelator, where Dr. Donoghue is employed.
SOURCE: Donoghue S et al. Headache. 2018 Jun;58(52):104,109,110.
REPORTING FROM the AHS Annual MEETING
Key clinical point: Migraine patients are most often way off base regarding their suspected attack triggers.
Major finding: Half of migraineurs suspect chocolate triggers their headache attacks, and almost 99% of them are wrong.
Study details: This prospective study included 774 migraineurs who completed a detailed electronic headache diary for at least 90 consecutive days, with correlations between migraine attacks and putative triggers being analyzed by proprietary software.
Disclosures: The study was sponsored by Curelator and presented by a company executive.
Source: Donoghue S et al. Headache. 2018 Jun;58(52):104,109,110.
Migraine and menopause: Longitudinal study shows what to expect
SAN FRANCISCO – What can women with migraine expect during the menopausal transition?
About 60% will experience a change in their headache pattern. And for 60% of that group, it’s a change for the worse, Yu-Chen Cheng, MD, reported at the annual meeting of the American Headache Society.
She presented a retrospective longitudinal study of 60 women with a preexisting history of migraine who were followed through the menopausal transition. All had long-term medical records available, including brain imaging results and hormonal laboratory data.
The impetus for the study was the fact that even though three-quarters of America’s estimated 38 million migraineurs are women, all of whom will eventually undergo menopause, the question of what happens to them headache-wise as they go through this process of permanent cessation of ovarian function has received little research attention.
“This longitudinal study addresses the pattern of change of migraine during menopausal transition, an important but underestimated and undermanaged issue. We need more awareness of this. We hope in the future that physicians can pay more attention to this and provide better treatment for our patients with impaired quality of life,” said Dr. Cheng, a neurologist and postdoctoral fellow at Massachusetts General Hospital and Harvard Medical School, Boston.
Of the 35 women who experienced a change in their migraine attacks in association with menopause, the change occurred perimenopausally or postmenopausally – that is, after the final menstrual period – in 84% of cases. Premenopausal change in migraine in women who hadn’t yet missed a menstrual period in the past 12 months was a less frequent event.
No significant demographic differences existed between the 35 women with migraine change during the menopausal transition and the 25 women whose headache pattern remained stable. However, there were significant differences between the two groups in terms of the change over time in serum estradiol and follicle-stimulating hormone (FSH) levels. The median estradiol level in women whose migraine pattern remained stable went from 29 pg/mL premenopausally to 16.5 pg/mL post menopause, a statistically nonsignificant difference. In contrast, the median estradiol in women who experienced a change in migraine pattern dropped from 52.6 pg/mL premenopausally to 22.5 pg/mL post menopause, which was a significant difference.
Similarly, the pre- to postmenopause change in median FSH from 38.6 to 62.8 IU/L in the stable migraine group didn’t attain statistical significance, while the bigger shift in the migraine change group – from 13.5 IU/L premenopausally to 62.2 IU/L post menopause, was statistically significant.
“So we can say there’s a greater hormonal change in the migraine change group for women in the menopausal transition,” the neurologist said. “This suggests the possibility that a significant steep decline in estradiol level may stimulate migraine change.”
Brain imaging findings in the two groups were similar: Nearly two-thirds of women in both groups had normal brain MRI results, while the rest had nonspecific findings.
Several female headache specialists in the audience rose to thank Dr. Cheng for shining new light on a major understudied issue with far-reaching quality-of-life implications. Could hormone replacement therapy possibly prevent worsening of migraine attacks in association with menopause? she was asked.
Dr. Cheng noted that hormone replacement therapy was used by about two-thirds of women whose migraines remained stable and a similar proportion of those whose headaches changed. But the study wasn’t designed or sized to examine any possible migraine-preventive effect of hormone therapy. That would properly be addressed in a large prospective study. Anecdotally, however, it has been her clinical impression as well as that of some of her fellow neurologists at Massachusetts General that hormone replacement therapy does seem to protect against worsening migraine attacks in menopause, she added.
Dr. Cheng reported having no financial conflicts regarding her National Institutes of Health–funded study.
SOURCE: Cheng Y-C and Maleki N. Headache. 2018;58:71. Abstract OR16.
SAN FRANCISCO – What can women with migraine expect during the menopausal transition?
About 60% will experience a change in their headache pattern. And for 60% of that group, it’s a change for the worse, Yu-Chen Cheng, MD, reported at the annual meeting of the American Headache Society.
She presented a retrospective longitudinal study of 60 women with a preexisting history of migraine who were followed through the menopausal transition. All had long-term medical records available, including brain imaging results and hormonal laboratory data.
The impetus for the study was the fact that even though three-quarters of America’s estimated 38 million migraineurs are women, all of whom will eventually undergo menopause, the question of what happens to them headache-wise as they go through this process of permanent cessation of ovarian function has received little research attention.
“This longitudinal study addresses the pattern of change of migraine during menopausal transition, an important but underestimated and undermanaged issue. We need more awareness of this. We hope in the future that physicians can pay more attention to this and provide better treatment for our patients with impaired quality of life,” said Dr. Cheng, a neurologist and postdoctoral fellow at Massachusetts General Hospital and Harvard Medical School, Boston.
Of the 35 women who experienced a change in their migraine attacks in association with menopause, the change occurred perimenopausally or postmenopausally – that is, after the final menstrual period – in 84% of cases. Premenopausal change in migraine in women who hadn’t yet missed a menstrual period in the past 12 months was a less frequent event.
No significant demographic differences existed between the 35 women with migraine change during the menopausal transition and the 25 women whose headache pattern remained stable. However, there were significant differences between the two groups in terms of the change over time in serum estradiol and follicle-stimulating hormone (FSH) levels. The median estradiol level in women whose migraine pattern remained stable went from 29 pg/mL premenopausally to 16.5 pg/mL post menopause, a statistically nonsignificant difference. In contrast, the median estradiol in women who experienced a change in migraine pattern dropped from 52.6 pg/mL premenopausally to 22.5 pg/mL post menopause, which was a significant difference.
Similarly, the pre- to postmenopause change in median FSH from 38.6 to 62.8 IU/L in the stable migraine group didn’t attain statistical significance, while the bigger shift in the migraine change group – from 13.5 IU/L premenopausally to 62.2 IU/L post menopause, was statistically significant.
“So we can say there’s a greater hormonal change in the migraine change group for women in the menopausal transition,” the neurologist said. “This suggests the possibility that a significant steep decline in estradiol level may stimulate migraine change.”
Brain imaging findings in the two groups were similar: Nearly two-thirds of women in both groups had normal brain MRI results, while the rest had nonspecific findings.
Several female headache specialists in the audience rose to thank Dr. Cheng for shining new light on a major understudied issue with far-reaching quality-of-life implications. Could hormone replacement therapy possibly prevent worsening of migraine attacks in association with menopause? she was asked.
Dr. Cheng noted that hormone replacement therapy was used by about two-thirds of women whose migraines remained stable and a similar proportion of those whose headaches changed. But the study wasn’t designed or sized to examine any possible migraine-preventive effect of hormone therapy. That would properly be addressed in a large prospective study. Anecdotally, however, it has been her clinical impression as well as that of some of her fellow neurologists at Massachusetts General that hormone replacement therapy does seem to protect against worsening migraine attacks in menopause, she added.
Dr. Cheng reported having no financial conflicts regarding her National Institutes of Health–funded study.
SOURCE: Cheng Y-C and Maleki N. Headache. 2018;58:71. Abstract OR16.
SAN FRANCISCO – What can women with migraine expect during the menopausal transition?
About 60% will experience a change in their headache pattern. And for 60% of that group, it’s a change for the worse, Yu-Chen Cheng, MD, reported at the annual meeting of the American Headache Society.
She presented a retrospective longitudinal study of 60 women with a preexisting history of migraine who were followed through the menopausal transition. All had long-term medical records available, including brain imaging results and hormonal laboratory data.
The impetus for the study was the fact that even though three-quarters of America’s estimated 38 million migraineurs are women, all of whom will eventually undergo menopause, the question of what happens to them headache-wise as they go through this process of permanent cessation of ovarian function has received little research attention.
“This longitudinal study addresses the pattern of change of migraine during menopausal transition, an important but underestimated and undermanaged issue. We need more awareness of this. We hope in the future that physicians can pay more attention to this and provide better treatment for our patients with impaired quality of life,” said Dr. Cheng, a neurologist and postdoctoral fellow at Massachusetts General Hospital and Harvard Medical School, Boston.
Of the 35 women who experienced a change in their migraine attacks in association with menopause, the change occurred perimenopausally or postmenopausally – that is, after the final menstrual period – in 84% of cases. Premenopausal change in migraine in women who hadn’t yet missed a menstrual period in the past 12 months was a less frequent event.
No significant demographic differences existed between the 35 women with migraine change during the menopausal transition and the 25 women whose headache pattern remained stable. However, there were significant differences between the two groups in terms of the change over time in serum estradiol and follicle-stimulating hormone (FSH) levels. The median estradiol level in women whose migraine pattern remained stable went from 29 pg/mL premenopausally to 16.5 pg/mL post menopause, a statistically nonsignificant difference. In contrast, the median estradiol in women who experienced a change in migraine pattern dropped from 52.6 pg/mL premenopausally to 22.5 pg/mL post menopause, which was a significant difference.
Similarly, the pre- to postmenopause change in median FSH from 38.6 to 62.8 IU/L in the stable migraine group didn’t attain statistical significance, while the bigger shift in the migraine change group – from 13.5 IU/L premenopausally to 62.2 IU/L post menopause, was statistically significant.
“So we can say there’s a greater hormonal change in the migraine change group for women in the menopausal transition,” the neurologist said. “This suggests the possibility that a significant steep decline in estradiol level may stimulate migraine change.”
Brain imaging findings in the two groups were similar: Nearly two-thirds of women in both groups had normal brain MRI results, while the rest had nonspecific findings.
Several female headache specialists in the audience rose to thank Dr. Cheng for shining new light on a major understudied issue with far-reaching quality-of-life implications. Could hormone replacement therapy possibly prevent worsening of migraine attacks in association with menopause? she was asked.
Dr. Cheng noted that hormone replacement therapy was used by about two-thirds of women whose migraines remained stable and a similar proportion of those whose headaches changed. But the study wasn’t designed or sized to examine any possible migraine-preventive effect of hormone therapy. That would properly be addressed in a large prospective study. Anecdotally, however, it has been her clinical impression as well as that of some of her fellow neurologists at Massachusetts General that hormone replacement therapy does seem to protect against worsening migraine attacks in menopause, she added.
Dr. Cheng reported having no financial conflicts regarding her National Institutes of Health–funded study.
SOURCE: Cheng Y-C and Maleki N. Headache. 2018;58:71. Abstract OR16.
REPORTING FROM THE AHS ANNUAL MEETING
Key clinical point: For migraineurs, the menopausal transition is a time of change in headache pattern, often for the worse.
Major finding: Sixty percent of migraineurs experienced a change in headache pattern during the menopausal transition, and for 60% of them it involved worsening migraine intensity and/or frequency.
Study details: This retrospective longitudinal study followed 60 women with migraine before and through the menopausal transition.
Disclosures: The presenter reported having no financial conflicts regarding her National Institutes of Health–funded study.
Source: Cheng Y-C and Maleki N. Headache. 2018;58:71. Abstract OR16.
Teaching opportunities of live surgery broadcasts debated
SAN DIEGO – Two thoracic societies are being challenged to review their rejection of at medical meetings.
The American Association for Thoracic Surgery and Society of Thoracic Surgeons “should modify their stance on live surgery as an educational tool like almost all of their sister organizations,” said Joseph E. Bavaria, MD, FACS, of the University of Pennsylvania, Philadelphia. “Presently, it is effectively a ban on the practice. But there are no data to suggest that it does harm to patients if done with proper constraints.”
Live broadcasts of surgeries at medical meetings are both common and controversial. Dr. Bavaria listed numerous recent thoracic meetings in Europe and Canada that featured live broadcasts. But, he noted, the AATS and STS are not supportive of the trend.
In a policy amended in 2017, the AATS states, among other things, that “national and international cardiothoracic societies should consider prohibiting live surgery broadcasts to large audiences at their annual meetings.” The STS policy, amended in 2016, is nearly identical. However, it adds language specifying that “violation of these guidelines may lead to disciplinary action by the Society.”
Both the AATS and STS policies state that surgeons should not take part in live broadcasts of operations that are intended for the public. And both policies say “generally, recorded broadcasts, either edited or unedited, are preferable to live surgery broadcasts because recordings intended for later broadcast pose fewer risks of harm to patients.”
The policies don’t elaborate on how a live broadcast of an operation might be more harmful than one aired at a later time. “Where are the data to support this statement?” Dr. Bavaria asked. “Is this what we call the expert opinion of a few people with gray hair? Our European and Canadian colleagues certainly don’t agree with [the policies] and might take issue with our sanctimonious lecturing that’s not supported by any data whatsoever.”
He pointed to a 2011 study that examined 250 cardiac procedures that were broadcast live to 32 scientific meetings. Researchers found that “there is no evidence for an excess perioperative risk for patients operated under the conditions of live broadcasting” (Eur J Cardiothorac Surg. 2011;40[2]:367-71).
A member of the audience at the AATS session pointed out that the study may be misleading because only top surgeons may be willing to perform procedures live on television. Dr. Bavaria responded by noting that the outcomes of surgeries performed on live video were not worse.
Skeptics have also expressed concern about the potential for sensationalism in live broadcasts and the drive for participants to make a splash: “the demands of ‘the performance,’ including questions and discussion with the audience, may divert the surgeon’s attention and produce an inferior outcome,” wrote three physicians in 2011 (J Surg Educ. 2011 Jan-Feb; 68[1]:58-61).
The trio also expressed worry about safety risks posed by extra equipment and extra people in the operating room during a live broadcast. However, Dr. Bavaria said the crowded conditions of an operation observed in person – instead of via video – could be worse: “You don’t have a sterile environment, you have people hanging around all over. A moderated live session could be better for the surgeon and the patient, rather than having a bunch of people in the room.”
Dr. Bavaria was also asked why surgeries couldn’t be recorded for airing later instead of being broadcast live, as this approach “takes you out of the nexus of having two masters, the patient and the audience.” In response, Dr. Bavaria said editing takes extra time in order to capture the nuances of the live procedure.
Dr. Bavaria reports no relevant disclosures.
Peter Angelos, MD, FACS, is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, chief of endocrine surgery, and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago. Dr. Angelos has no disclosures.
Peter Angelos, MD, FACS, is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, chief of endocrine surgery, and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago. Dr. Angelos has no disclosures.
Peter Angelos, MD, FACS, is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, chief of endocrine surgery, and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago. Dr. Angelos has no disclosures.
SAN DIEGO – Two thoracic societies are being challenged to review their rejection of at medical meetings.
The American Association for Thoracic Surgery and Society of Thoracic Surgeons “should modify their stance on live surgery as an educational tool like almost all of their sister organizations,” said Joseph E. Bavaria, MD, FACS, of the University of Pennsylvania, Philadelphia. “Presently, it is effectively a ban on the practice. But there are no data to suggest that it does harm to patients if done with proper constraints.”
Live broadcasts of surgeries at medical meetings are both common and controversial. Dr. Bavaria listed numerous recent thoracic meetings in Europe and Canada that featured live broadcasts. But, he noted, the AATS and STS are not supportive of the trend.
In a policy amended in 2017, the AATS states, among other things, that “national and international cardiothoracic societies should consider prohibiting live surgery broadcasts to large audiences at their annual meetings.” The STS policy, amended in 2016, is nearly identical. However, it adds language specifying that “violation of these guidelines may lead to disciplinary action by the Society.”
Both the AATS and STS policies state that surgeons should not take part in live broadcasts of operations that are intended for the public. And both policies say “generally, recorded broadcasts, either edited or unedited, are preferable to live surgery broadcasts because recordings intended for later broadcast pose fewer risks of harm to patients.”
The policies don’t elaborate on how a live broadcast of an operation might be more harmful than one aired at a later time. “Where are the data to support this statement?” Dr. Bavaria asked. “Is this what we call the expert opinion of a few people with gray hair? Our European and Canadian colleagues certainly don’t agree with [the policies] and might take issue with our sanctimonious lecturing that’s not supported by any data whatsoever.”
He pointed to a 2011 study that examined 250 cardiac procedures that were broadcast live to 32 scientific meetings. Researchers found that “there is no evidence for an excess perioperative risk for patients operated under the conditions of live broadcasting” (Eur J Cardiothorac Surg. 2011;40[2]:367-71).
A member of the audience at the AATS session pointed out that the study may be misleading because only top surgeons may be willing to perform procedures live on television. Dr. Bavaria responded by noting that the outcomes of surgeries performed on live video were not worse.
Skeptics have also expressed concern about the potential for sensationalism in live broadcasts and the drive for participants to make a splash: “the demands of ‘the performance,’ including questions and discussion with the audience, may divert the surgeon’s attention and produce an inferior outcome,” wrote three physicians in 2011 (J Surg Educ. 2011 Jan-Feb; 68[1]:58-61).
The trio also expressed worry about safety risks posed by extra equipment and extra people in the operating room during a live broadcast. However, Dr. Bavaria said the crowded conditions of an operation observed in person – instead of via video – could be worse: “You don’t have a sterile environment, you have people hanging around all over. A moderated live session could be better for the surgeon and the patient, rather than having a bunch of people in the room.”
Dr. Bavaria was also asked why surgeries couldn’t be recorded for airing later instead of being broadcast live, as this approach “takes you out of the nexus of having two masters, the patient and the audience.” In response, Dr. Bavaria said editing takes extra time in order to capture the nuances of the live procedure.
Dr. Bavaria reports no relevant disclosures.
SAN DIEGO – Two thoracic societies are being challenged to review their rejection of at medical meetings.
The American Association for Thoracic Surgery and Society of Thoracic Surgeons “should modify their stance on live surgery as an educational tool like almost all of their sister organizations,” said Joseph E. Bavaria, MD, FACS, of the University of Pennsylvania, Philadelphia. “Presently, it is effectively a ban on the practice. But there are no data to suggest that it does harm to patients if done with proper constraints.”
Live broadcasts of surgeries at medical meetings are both common and controversial. Dr. Bavaria listed numerous recent thoracic meetings in Europe and Canada that featured live broadcasts. But, he noted, the AATS and STS are not supportive of the trend.
In a policy amended in 2017, the AATS states, among other things, that “national and international cardiothoracic societies should consider prohibiting live surgery broadcasts to large audiences at their annual meetings.” The STS policy, amended in 2016, is nearly identical. However, it adds language specifying that “violation of these guidelines may lead to disciplinary action by the Society.”
Both the AATS and STS policies state that surgeons should not take part in live broadcasts of operations that are intended for the public. And both policies say “generally, recorded broadcasts, either edited or unedited, are preferable to live surgery broadcasts because recordings intended for later broadcast pose fewer risks of harm to patients.”
The policies don’t elaborate on how a live broadcast of an operation might be more harmful than one aired at a later time. “Where are the data to support this statement?” Dr. Bavaria asked. “Is this what we call the expert opinion of a few people with gray hair? Our European and Canadian colleagues certainly don’t agree with [the policies] and might take issue with our sanctimonious lecturing that’s not supported by any data whatsoever.”
He pointed to a 2011 study that examined 250 cardiac procedures that were broadcast live to 32 scientific meetings. Researchers found that “there is no evidence for an excess perioperative risk for patients operated under the conditions of live broadcasting” (Eur J Cardiothorac Surg. 2011;40[2]:367-71).
A member of the audience at the AATS session pointed out that the study may be misleading because only top surgeons may be willing to perform procedures live on television. Dr. Bavaria responded by noting that the outcomes of surgeries performed on live video were not worse.
Skeptics have also expressed concern about the potential for sensationalism in live broadcasts and the drive for participants to make a splash: “the demands of ‘the performance,’ including questions and discussion with the audience, may divert the surgeon’s attention and produce an inferior outcome,” wrote three physicians in 2011 (J Surg Educ. 2011 Jan-Feb; 68[1]:58-61).
The trio also expressed worry about safety risks posed by extra equipment and extra people in the operating room during a live broadcast. However, Dr. Bavaria said the crowded conditions of an operation observed in person – instead of via video – could be worse: “You don’t have a sterile environment, you have people hanging around all over. A moderated live session could be better for the surgeon and the patient, rather than having a bunch of people in the room.”
Dr. Bavaria was also asked why surgeries couldn’t be recorded for airing later instead of being broadcast live, as this approach “takes you out of the nexus of having two masters, the patient and the audience.” In response, Dr. Bavaria said editing takes extra time in order to capture the nuances of the live procedure.
Dr. Bavaria reports no relevant disclosures.
REPORTING FROM AATS
Malignant pleural mesothelioma guidelines often are ignored
SAN DIEGO – National guidelines for the treatment of malignant pleural mesothelioma often are not followed, a new study showed, with fewer than one-third of patients receiving cancer-directed surgery.
Another 32% received no treatment, although that didn’t seem to have an impact on median months of survival.
Still, “there can be a wide variation in median survival time, depending on clinical factors and tumor characteristics,” said study coauthor Harmik Soukiasian, MD, of Cedars-Sinai Medical Center, Los Angeles. “Given the variation in prognosis, it is quite astonishing that over 30% of MPM patients are not receiving any form of treatment. As clinicians armed with these data, we need to investigate why that is.”
Dr. Soukiasian presented the study findings at the annual meeting of the American Association for Thoracic Surgery.
MPM, a rare cancer, is mainly linked to asbestos exposure. “MPM is almost always a fatal disease, and the prognosis can only be modestly influenced by oncological treatments,” according to the authors of guidelines released in 2013. “The diagnostic process can be complex, with highly specialized advice frequently required to arrive at a definite diagnosis. Treatment varies from therapeutic nihilism to radical combined-modality treatment approaches” (J Thorac Dis. 2013 Dec;5[6]:E254-E307).
Surgical resection is a controversial treatment for MPM, Dr. Soukiasian said. It is “based on the principle of macroscopic resection of solid tumor with adjuvant therapy to treat micrometastatic disease,” he explained. “Cancer-directed surgery for MPM is usually reserved for localized epithelial type histology and is associated with a 5-year survival rate of 15%.”
For the new study, the investigators tracked 3,834 patients in the National Cancer Database (2004-2014) diagnosed with MPM clinical stages I-III. Most had epithelioid MPM (69%), with sarcomatoid (17%) and mixed subtype (15%) making up the rest. They examined whether patient treatment complied with the National Comprehensive Cancer Network (NCCN) guidelines, which recommend surgery in resectable epithelioid MPM.
“Our study revealed significant lack of compliance with NCCN guidelines, as well as many disparities in the management of MPM,” Dr. Soukiasian said. “For the overall cohort, 32.3% of patients did not receive any treatment, 18.1% had surgery plus chemotherapy, 38.6% chemotherapy alone, and only 7% received trimodality therapy. In patients with epithelial histology, surgery was significantly underutilized, with only 30% of patients receiving cancer-directed surgery.”
In addition, he said, “our study reveals several disparities that affect compliance with NCCN guidelines. Treatment disparities were observed in women, octogenarians, the uninsured, the Medicaid-insured, and in patients with comorbidities. Guideline adherence was significantly increased in academic and high-volume hospitals with an associated increase in survival.”
But the study also found that median survival estimates were similar regardless of treatment: 10 months for no treatment, 15 months for chemotherapy only, 17 months for surgery only, and 22 months for surgery plus chemotherapy.
During the AATS presentation, an audience member asked about how performance status – a measure of a person’s ability to perform everyday activities – affects the eligibility for surgery.
“It’s quite common for low performance status to exclude someone from surgery,” the audience member said. “Some of these patients are very sick.”
Dr. Soukiasian acknowledged that performance status was not included in the data. The study was focused on the gap between guidelines and real-world practice, and generated questions of why and about the potential opportunity for improved treatment of these patients.
How do patient choices, cost, and quality of life factor in? “These are very important questions and concerns,” Dr. Soukiasian said. “Although our research does not provide data or conclusions on quality of life or cost, these topics will be important to address in follow-up studies to elucidate possible barriers in the treatment of MPM and the initiation of future educational opportunities for our patients.”
No disclosures and no study funding were reported.
SOURCE: Espinoza-Mercado F et al. General Thoracic Surgery Simultaneous Scientific Session. Abstract 18.
SAN DIEGO – National guidelines for the treatment of malignant pleural mesothelioma often are not followed, a new study showed, with fewer than one-third of patients receiving cancer-directed surgery.
Another 32% received no treatment, although that didn’t seem to have an impact on median months of survival.
Still, “there can be a wide variation in median survival time, depending on clinical factors and tumor characteristics,” said study coauthor Harmik Soukiasian, MD, of Cedars-Sinai Medical Center, Los Angeles. “Given the variation in prognosis, it is quite astonishing that over 30% of MPM patients are not receiving any form of treatment. As clinicians armed with these data, we need to investigate why that is.”
Dr. Soukiasian presented the study findings at the annual meeting of the American Association for Thoracic Surgery.
MPM, a rare cancer, is mainly linked to asbestos exposure. “MPM is almost always a fatal disease, and the prognosis can only be modestly influenced by oncological treatments,” according to the authors of guidelines released in 2013. “The diagnostic process can be complex, with highly specialized advice frequently required to arrive at a definite diagnosis. Treatment varies from therapeutic nihilism to radical combined-modality treatment approaches” (J Thorac Dis. 2013 Dec;5[6]:E254-E307).
Surgical resection is a controversial treatment for MPM, Dr. Soukiasian said. It is “based on the principle of macroscopic resection of solid tumor with adjuvant therapy to treat micrometastatic disease,” he explained. “Cancer-directed surgery for MPM is usually reserved for localized epithelial type histology and is associated with a 5-year survival rate of 15%.”
For the new study, the investigators tracked 3,834 patients in the National Cancer Database (2004-2014) diagnosed with MPM clinical stages I-III. Most had epithelioid MPM (69%), with sarcomatoid (17%) and mixed subtype (15%) making up the rest. They examined whether patient treatment complied with the National Comprehensive Cancer Network (NCCN) guidelines, which recommend surgery in resectable epithelioid MPM.
“Our study revealed significant lack of compliance with NCCN guidelines, as well as many disparities in the management of MPM,” Dr. Soukiasian said. “For the overall cohort, 32.3% of patients did not receive any treatment, 18.1% had surgery plus chemotherapy, 38.6% chemotherapy alone, and only 7% received trimodality therapy. In patients with epithelial histology, surgery was significantly underutilized, with only 30% of patients receiving cancer-directed surgery.”
In addition, he said, “our study reveals several disparities that affect compliance with NCCN guidelines. Treatment disparities were observed in women, octogenarians, the uninsured, the Medicaid-insured, and in patients with comorbidities. Guideline adherence was significantly increased in academic and high-volume hospitals with an associated increase in survival.”
But the study also found that median survival estimates were similar regardless of treatment: 10 months for no treatment, 15 months for chemotherapy only, 17 months for surgery only, and 22 months for surgery plus chemotherapy.
During the AATS presentation, an audience member asked about how performance status – a measure of a person’s ability to perform everyday activities – affects the eligibility for surgery.
“It’s quite common for low performance status to exclude someone from surgery,” the audience member said. “Some of these patients are very sick.”
Dr. Soukiasian acknowledged that performance status was not included in the data. The study was focused on the gap between guidelines and real-world practice, and generated questions of why and about the potential opportunity for improved treatment of these patients.
How do patient choices, cost, and quality of life factor in? “These are very important questions and concerns,” Dr. Soukiasian said. “Although our research does not provide data or conclusions on quality of life or cost, these topics will be important to address in follow-up studies to elucidate possible barriers in the treatment of MPM and the initiation of future educational opportunities for our patients.”
No disclosures and no study funding were reported.
SOURCE: Espinoza-Mercado F et al. General Thoracic Surgery Simultaneous Scientific Session. Abstract 18.
SAN DIEGO – National guidelines for the treatment of malignant pleural mesothelioma often are not followed, a new study showed, with fewer than one-third of patients receiving cancer-directed surgery.
Another 32% received no treatment, although that didn’t seem to have an impact on median months of survival.
Still, “there can be a wide variation in median survival time, depending on clinical factors and tumor characteristics,” said study coauthor Harmik Soukiasian, MD, of Cedars-Sinai Medical Center, Los Angeles. “Given the variation in prognosis, it is quite astonishing that over 30% of MPM patients are not receiving any form of treatment. As clinicians armed with these data, we need to investigate why that is.”
Dr. Soukiasian presented the study findings at the annual meeting of the American Association for Thoracic Surgery.
MPM, a rare cancer, is mainly linked to asbestos exposure. “MPM is almost always a fatal disease, and the prognosis can only be modestly influenced by oncological treatments,” according to the authors of guidelines released in 2013. “The diagnostic process can be complex, with highly specialized advice frequently required to arrive at a definite diagnosis. Treatment varies from therapeutic nihilism to radical combined-modality treatment approaches” (J Thorac Dis. 2013 Dec;5[6]:E254-E307).
Surgical resection is a controversial treatment for MPM, Dr. Soukiasian said. It is “based on the principle of macroscopic resection of solid tumor with adjuvant therapy to treat micrometastatic disease,” he explained. “Cancer-directed surgery for MPM is usually reserved for localized epithelial type histology and is associated with a 5-year survival rate of 15%.”
For the new study, the investigators tracked 3,834 patients in the National Cancer Database (2004-2014) diagnosed with MPM clinical stages I-III. Most had epithelioid MPM (69%), with sarcomatoid (17%) and mixed subtype (15%) making up the rest. They examined whether patient treatment complied with the National Comprehensive Cancer Network (NCCN) guidelines, which recommend surgery in resectable epithelioid MPM.
“Our study revealed significant lack of compliance with NCCN guidelines, as well as many disparities in the management of MPM,” Dr. Soukiasian said. “For the overall cohort, 32.3% of patients did not receive any treatment, 18.1% had surgery plus chemotherapy, 38.6% chemotherapy alone, and only 7% received trimodality therapy. In patients with epithelial histology, surgery was significantly underutilized, with only 30% of patients receiving cancer-directed surgery.”
In addition, he said, “our study reveals several disparities that affect compliance with NCCN guidelines. Treatment disparities were observed in women, octogenarians, the uninsured, the Medicaid-insured, and in patients with comorbidities. Guideline adherence was significantly increased in academic and high-volume hospitals with an associated increase in survival.”
But the study also found that median survival estimates were similar regardless of treatment: 10 months for no treatment, 15 months for chemotherapy only, 17 months for surgery only, and 22 months for surgery plus chemotherapy.
During the AATS presentation, an audience member asked about how performance status – a measure of a person’s ability to perform everyday activities – affects the eligibility for surgery.
“It’s quite common for low performance status to exclude someone from surgery,” the audience member said. “Some of these patients are very sick.”
Dr. Soukiasian acknowledged that performance status was not included in the data. The study was focused on the gap between guidelines and real-world practice, and generated questions of why and about the potential opportunity for improved treatment of these patients.
How do patient choices, cost, and quality of life factor in? “These are very important questions and concerns,” Dr. Soukiasian said. “Although our research does not provide data or conclusions on quality of life or cost, these topics will be important to address in follow-up studies to elucidate possible barriers in the treatment of MPM and the initiation of future educational opportunities for our patients.”
No disclosures and no study funding were reported.
SOURCE: Espinoza-Mercado F et al. General Thoracic Surgery Simultaneous Scientific Session. Abstract 18.
REPORTING FROM THE AATS ANNUAL MEETING
Key clinical point:
Major finding: Guidelines recommend surgery in epithelioid MPM, but only 30% of patients received it.
Study details: Analysis of 3,834 patients diagnosed with MPM clinical stages I-III during 2004-2014.
Disclosures: No disclosures and no study funding were reported.
Source: Espinoza-Mercado F et al. General Thoracic Surgery Simultaneous Scientific Session. Abstract 18.