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VIDEO: Hands-off yields best brain arteriovenous malformation outcomes
LOS ANGELES – Hang a do-not-disturb sign on brain arteriovenous malformations.
Patients who underwent invasive interventions to repair an unruptured arteriovenous malformation (AVM) in their brain faced a greater than two-fold increased rate of death or stroke during an average 4 years of follow-up, compared with patients who received medical treatment only with no active intervention, Dr. Christian Stapf reported at the International Stroke Conference.
When analyzed on an intention-to-treat basis, for every five AVM patients treated by endovascular surgery, conventional surgery, or radiotherapy, one additional patient died or had a stroke, compared with the death or stroke rate among control patients who received only medical management. When analyzed based on the treatments that patients actually received, the number-needed-to-harm fell to one excess death or stroke for every three AVM patients who underwent an invasive procedure, compared with control patients, reported Dr. Stapf, a professor in the department of neurosciences at the University of Montreal.
The results from A Randomized Trial of Unruptured Brain AVMs (ARUBA) “show us that we clearly have not been as good as we thought in helping patients against their stroke risk,” said Dr. Stapf in a video interview during the meeting. “Given that the risk of death or stroke was reduced three- to fivefold with no [invasive] treatment and leaving the AVM alone makes us think that we can’t recommend preventive intervention with currently-used techniques. Living with the AVM seems like the far better option.”
The ARUBA study, run at 39 centers in nine countries including 13 U.S. centers, randomized 226 patients with unruptured AVMs before the study’s data safety and monitoring board stopped study enrollment prematurely in April 2013. The study group included 110 patients randomized to receive medical interventions only and 116 randomized to medical intervention plus “best possible” AVM eradication. The exact type of eradication for each patient was left up to local clinicians, who tailored the intervention to address the size, location, and anatomy of each AVM. Medical management included steps such as treatment with antiepileptic drugs to treat seizures, various treatments for headaches, and physiotherapy for patients with neurologic deficits.
The study’s primary endpoint was the combined rate of death or stroke, which occurred in 41 of the 116 patients (35%) randomized to receive an invasive intervention and in 15 of the 110 (14%) randomized to medical treatment only during an average follow-up of 50 months, with many patients followed for 5 years.
When analyzed by the treatment patients actually received, 106 underwent an invasive intervention and 43 of these patients (41%) died or had a stroke, and 120 patients received medical treatments only, of whom 13 (11%) died or had a stroke.
A secondary endpoint was the rate of death or disability after 5-year follow-up, with disability defined as a modified Rankin Scale score of 2 or more. This occurred in 38% of the 45 patients who underwent AVM eradication and had this follow-up available, and in 18% of 51 patients who had medial treatment only and received this follow-up.
Interim results from the study came out 2 years ago, with an average follow-up of 33 months (Lancet. 2014 Feb 15;383[9917]:614-21), but the trial was designed to have 5-year follow-up, largely accomplished in the new data reported by Dr. Stapf.
Many clinicians had already abandoned invasive interventions to treat brain AVMs following release of the interim results, and Dr. Stapf predicted that this trend will further strengthen now that the final results are in and confirm the earlier indication of hazard. Until the ARUBA results became available, clinicians had presumed invasive interventions to resolve or minimize malformations were beneficial based on intuition. ARUBA is the first systematic comparison of procedures versus a hands-off approach for brain AVMs, he said.
“Neurologists will now be less likely to refer patients for intervention, and interventionalists will be less enthusiastic to perform procedures,” Dr. Stapf said during the meeting, sponsored by the American Heart Association. In addition, anyone now performing an intervention in routine practice would need to consider the possible legal implications if the patient were to have a bad outcome. Dr. Stapf also noted that some professional societies are now considering recommendations against routine interventions. He conceded that some invasive interventions might still occur for selected cases on an investigational basis, but the ARUBA results “set the bar very high against performing any new interventions,” he concluded.
Approximately 3,000 patients annually are newly diagnosed with an unruptured brain AVM in the United States and Canada, he estimated.
ARUBA received no commercial support. Dr. Stapf had no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
LOS ANGELES – Hang a do-not-disturb sign on brain arteriovenous malformations.
Patients who underwent invasive interventions to repair an unruptured arteriovenous malformation (AVM) in their brain faced a greater than two-fold increased rate of death or stroke during an average 4 years of follow-up, compared with patients who received medical treatment only with no active intervention, Dr. Christian Stapf reported at the International Stroke Conference.
When analyzed on an intention-to-treat basis, for every five AVM patients treated by endovascular surgery, conventional surgery, or radiotherapy, one additional patient died or had a stroke, compared with the death or stroke rate among control patients who received only medical management. When analyzed based on the treatments that patients actually received, the number-needed-to-harm fell to one excess death or stroke for every three AVM patients who underwent an invasive procedure, compared with control patients, reported Dr. Stapf, a professor in the department of neurosciences at the University of Montreal.
The results from A Randomized Trial of Unruptured Brain AVMs (ARUBA) “show us that we clearly have not been as good as we thought in helping patients against their stroke risk,” said Dr. Stapf in a video interview during the meeting. “Given that the risk of death or stroke was reduced three- to fivefold with no [invasive] treatment and leaving the AVM alone makes us think that we can’t recommend preventive intervention with currently-used techniques. Living with the AVM seems like the far better option.”
The ARUBA study, run at 39 centers in nine countries including 13 U.S. centers, randomized 226 patients with unruptured AVMs before the study’s data safety and monitoring board stopped study enrollment prematurely in April 2013. The study group included 110 patients randomized to receive medical interventions only and 116 randomized to medical intervention plus “best possible” AVM eradication. The exact type of eradication for each patient was left up to local clinicians, who tailored the intervention to address the size, location, and anatomy of each AVM. Medical management included steps such as treatment with antiepileptic drugs to treat seizures, various treatments for headaches, and physiotherapy for patients with neurologic deficits.
The study’s primary endpoint was the combined rate of death or stroke, which occurred in 41 of the 116 patients (35%) randomized to receive an invasive intervention and in 15 of the 110 (14%) randomized to medical treatment only during an average follow-up of 50 months, with many patients followed for 5 years.
When analyzed by the treatment patients actually received, 106 underwent an invasive intervention and 43 of these patients (41%) died or had a stroke, and 120 patients received medical treatments only, of whom 13 (11%) died or had a stroke.
A secondary endpoint was the rate of death or disability after 5-year follow-up, with disability defined as a modified Rankin Scale score of 2 or more. This occurred in 38% of the 45 patients who underwent AVM eradication and had this follow-up available, and in 18% of 51 patients who had medial treatment only and received this follow-up.
Interim results from the study came out 2 years ago, with an average follow-up of 33 months (Lancet. 2014 Feb 15;383[9917]:614-21), but the trial was designed to have 5-year follow-up, largely accomplished in the new data reported by Dr. Stapf.
Many clinicians had already abandoned invasive interventions to treat brain AVMs following release of the interim results, and Dr. Stapf predicted that this trend will further strengthen now that the final results are in and confirm the earlier indication of hazard. Until the ARUBA results became available, clinicians had presumed invasive interventions to resolve or minimize malformations were beneficial based on intuition. ARUBA is the first systematic comparison of procedures versus a hands-off approach for brain AVMs, he said.
“Neurologists will now be less likely to refer patients for intervention, and interventionalists will be less enthusiastic to perform procedures,” Dr. Stapf said during the meeting, sponsored by the American Heart Association. In addition, anyone now performing an intervention in routine practice would need to consider the possible legal implications if the patient were to have a bad outcome. Dr. Stapf also noted that some professional societies are now considering recommendations against routine interventions. He conceded that some invasive interventions might still occur for selected cases on an investigational basis, but the ARUBA results “set the bar very high against performing any new interventions,” he concluded.
Approximately 3,000 patients annually are newly diagnosed with an unruptured brain AVM in the United States and Canada, he estimated.
ARUBA received no commercial support. Dr. Stapf had no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
LOS ANGELES – Hang a do-not-disturb sign on brain arteriovenous malformations.
Patients who underwent invasive interventions to repair an unruptured arteriovenous malformation (AVM) in their brain faced a greater than two-fold increased rate of death or stroke during an average 4 years of follow-up, compared with patients who received medical treatment only with no active intervention, Dr. Christian Stapf reported at the International Stroke Conference.
When analyzed on an intention-to-treat basis, for every five AVM patients treated by endovascular surgery, conventional surgery, or radiotherapy, one additional patient died or had a stroke, compared with the death or stroke rate among control patients who received only medical management. When analyzed based on the treatments that patients actually received, the number-needed-to-harm fell to one excess death or stroke for every three AVM patients who underwent an invasive procedure, compared with control patients, reported Dr. Stapf, a professor in the department of neurosciences at the University of Montreal.
The results from A Randomized Trial of Unruptured Brain AVMs (ARUBA) “show us that we clearly have not been as good as we thought in helping patients against their stroke risk,” said Dr. Stapf in a video interview during the meeting. “Given that the risk of death or stroke was reduced three- to fivefold with no [invasive] treatment and leaving the AVM alone makes us think that we can’t recommend preventive intervention with currently-used techniques. Living with the AVM seems like the far better option.”
The ARUBA study, run at 39 centers in nine countries including 13 U.S. centers, randomized 226 patients with unruptured AVMs before the study’s data safety and monitoring board stopped study enrollment prematurely in April 2013. The study group included 110 patients randomized to receive medical interventions only and 116 randomized to medical intervention plus “best possible” AVM eradication. The exact type of eradication for each patient was left up to local clinicians, who tailored the intervention to address the size, location, and anatomy of each AVM. Medical management included steps such as treatment with antiepileptic drugs to treat seizures, various treatments for headaches, and physiotherapy for patients with neurologic deficits.
The study’s primary endpoint was the combined rate of death or stroke, which occurred in 41 of the 116 patients (35%) randomized to receive an invasive intervention and in 15 of the 110 (14%) randomized to medical treatment only during an average follow-up of 50 months, with many patients followed for 5 years.
When analyzed by the treatment patients actually received, 106 underwent an invasive intervention and 43 of these patients (41%) died or had a stroke, and 120 patients received medical treatments only, of whom 13 (11%) died or had a stroke.
A secondary endpoint was the rate of death or disability after 5-year follow-up, with disability defined as a modified Rankin Scale score of 2 or more. This occurred in 38% of the 45 patients who underwent AVM eradication and had this follow-up available, and in 18% of 51 patients who had medial treatment only and received this follow-up.
Interim results from the study came out 2 years ago, with an average follow-up of 33 months (Lancet. 2014 Feb 15;383[9917]:614-21), but the trial was designed to have 5-year follow-up, largely accomplished in the new data reported by Dr. Stapf.
Many clinicians had already abandoned invasive interventions to treat brain AVMs following release of the interim results, and Dr. Stapf predicted that this trend will further strengthen now that the final results are in and confirm the earlier indication of hazard. Until the ARUBA results became available, clinicians had presumed invasive interventions to resolve or minimize malformations were beneficial based on intuition. ARUBA is the first systematic comparison of procedures versus a hands-off approach for brain AVMs, he said.
“Neurologists will now be less likely to refer patients for intervention, and interventionalists will be less enthusiastic to perform procedures,” Dr. Stapf said during the meeting, sponsored by the American Heart Association. In addition, anyone now performing an intervention in routine practice would need to consider the possible legal implications if the patient were to have a bad outcome. Dr. Stapf also noted that some professional societies are now considering recommendations against routine interventions. He conceded that some invasive interventions might still occur for selected cases on an investigational basis, but the ARUBA results “set the bar very high against performing any new interventions,” he concluded.
Approximately 3,000 patients annually are newly diagnosed with an unruptured brain AVM in the United States and Canada, he estimated.
ARUBA received no commercial support. Dr. Stapf had no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
AT THE INTERNATIONAL STROKE CONFERENCE
Key clinical point: The first direct comparison of invasive treatment and medical management only for intracerebral arteriovenous malformations showed substantial hazard from active intervention.
Major finding: The incidence of death or stroke was 35% with active intervention and 14% with medical management only.
Data source: ARUBA, a multicenter, prospective, international, randomized study with 226 patients.
Disclosures: ARUBA received no commercial support. Dr. Stapf had no disclosures.
VTE prophylaxis within 72 hours seems safe in severe TBI
SAN ANTONIO – Initiation of venous thromboembolism prophylaxis within 72 hours of severe traumatic brain injury (TBI) reduced the odds of venous thromboembolism by 50% without increasing subsequent intracranial complications or death in a large, propensity-matched cohort study from the University of Toronto.
The investigators matched 1,234 adult patients given prophylaxis before 72 hours – the early-prophylaxis (EP) group – to 1,234 given prophylaxis at 72 hours or later – the late-prophylaxis (LP) group – based on demographics, injury characteristics, intracranial lesions, early neurosurgical procedures, and prophylaxis type.
EP patients had a significantly lower rate of pulmonary embolism (1.1% vs. 2.4%; odds ratio, 0.48; 95% confidence interval, 0.25-0.91) and deep vein thrombosis (4.2% vs. 7.9%; OR, 0.51; 95% CI, 0.36-0.72), with no significant increase in the risk of death (9.8% EP vs. 9% LP; OR, 1.1; 95% CI 0.84-1.4) or late secondary craniotomy/-ectomy (EP 2.5% vs. LP 2.9%; OR, 0.86; 95% CI 0.53-1.4) or intracranial monitoring/drainage (EP 1.1% vs. LP 1.4%; OR, 0.76; 95% CI 0.37-1.6) from VTE complications or other reasons.
“Practice guidelines say we should initiate VTE [venous thromboembolism] prophylaxis” in severe TBI “as early as possible. It’s a very loose recommendation,” so some centers wait 72 hours or longer for fear of extending intracranial hemorrhages. Pending results from prospective trials, “our study lends evidence that early prophylaxis in this population may be safe,” said investigator and University of Toronto general surgery resident, Dr. James Byrne.
The study included 3,634 severe, adult TBI patients in the American College of Surgeons Trauma Quality Improvement Program database from 2012-2014. The subjects had head Abbreviated Injury Scale (AIS) scores of at least 3, Glasgow Coma Scale scores of no more than 8, and, in almost all cases, initial surgeries within 48 hours. Injury was due to blunt trauma. Patients who died or were discharged within 5 days of their injury and those with severe injuries to other body areas were excluded from the analysis.
The median time to starting VTE prophylaxis was 84 hours across the 186 trauma centers in the study, but ranged from 48-150 hours. Centers started prophylaxis within 72 hours in 18%-54% of patients. Fifty-five percent of patients had prophylaxis with low-molecular-weight heparin, and the rest with unfractionated heparin. Overall, 1.7% of patients developed pulmonary emboli, and 6.5% deep vein thromboses. Less than 3% had secondary neurosurgical interventions.
Prophylaxis was more likely to be delayed past 72 hours in patients with higher head AIS scores; subdural hematomas; subarachnoid hemorrhages; blood transfusions within 12 hours of admission; and early neurosurgery. Low-molecular-weight heparin was the more likely option past 72 hours.
Among the 114 centers who treated 10 or more patients, there was a continuous trend toward lower VTE rates with higher EP use, a rate of 9.1% in centers using EP in 18% of patients, but 6.1% in centers using it in 54% (P = .126).
The decision of when to start prophylaxis in severe TBI “still needs to be made at the patient level, but it may be safe to start earlier than 72 hours,” Dr. Byrne said.
The median age in the study was about 43 years, and three-quarters of the subjects were men. Most of the injuries were due to falls or motor vehicle crashes.
Dr. Byrne had no disclosures.
SAN ANTONIO – Initiation of venous thromboembolism prophylaxis within 72 hours of severe traumatic brain injury (TBI) reduced the odds of venous thromboembolism by 50% without increasing subsequent intracranial complications or death in a large, propensity-matched cohort study from the University of Toronto.
The investigators matched 1,234 adult patients given prophylaxis before 72 hours – the early-prophylaxis (EP) group – to 1,234 given prophylaxis at 72 hours or later – the late-prophylaxis (LP) group – based on demographics, injury characteristics, intracranial lesions, early neurosurgical procedures, and prophylaxis type.
EP patients had a significantly lower rate of pulmonary embolism (1.1% vs. 2.4%; odds ratio, 0.48; 95% confidence interval, 0.25-0.91) and deep vein thrombosis (4.2% vs. 7.9%; OR, 0.51; 95% CI, 0.36-0.72), with no significant increase in the risk of death (9.8% EP vs. 9% LP; OR, 1.1; 95% CI 0.84-1.4) or late secondary craniotomy/-ectomy (EP 2.5% vs. LP 2.9%; OR, 0.86; 95% CI 0.53-1.4) or intracranial monitoring/drainage (EP 1.1% vs. LP 1.4%; OR, 0.76; 95% CI 0.37-1.6) from VTE complications or other reasons.
“Practice guidelines say we should initiate VTE [venous thromboembolism] prophylaxis” in severe TBI “as early as possible. It’s a very loose recommendation,” so some centers wait 72 hours or longer for fear of extending intracranial hemorrhages. Pending results from prospective trials, “our study lends evidence that early prophylaxis in this population may be safe,” said investigator and University of Toronto general surgery resident, Dr. James Byrne.
The study included 3,634 severe, adult TBI patients in the American College of Surgeons Trauma Quality Improvement Program database from 2012-2014. The subjects had head Abbreviated Injury Scale (AIS) scores of at least 3, Glasgow Coma Scale scores of no more than 8, and, in almost all cases, initial surgeries within 48 hours. Injury was due to blunt trauma. Patients who died or were discharged within 5 days of their injury and those with severe injuries to other body areas were excluded from the analysis.
The median time to starting VTE prophylaxis was 84 hours across the 186 trauma centers in the study, but ranged from 48-150 hours. Centers started prophylaxis within 72 hours in 18%-54% of patients. Fifty-five percent of patients had prophylaxis with low-molecular-weight heparin, and the rest with unfractionated heparin. Overall, 1.7% of patients developed pulmonary emboli, and 6.5% deep vein thromboses. Less than 3% had secondary neurosurgical interventions.
Prophylaxis was more likely to be delayed past 72 hours in patients with higher head AIS scores; subdural hematomas; subarachnoid hemorrhages; blood transfusions within 12 hours of admission; and early neurosurgery. Low-molecular-weight heparin was the more likely option past 72 hours.
Among the 114 centers who treated 10 or more patients, there was a continuous trend toward lower VTE rates with higher EP use, a rate of 9.1% in centers using EP in 18% of patients, but 6.1% in centers using it in 54% (P = .126).
The decision of when to start prophylaxis in severe TBI “still needs to be made at the patient level, but it may be safe to start earlier than 72 hours,” Dr. Byrne said.
The median age in the study was about 43 years, and three-quarters of the subjects were men. Most of the injuries were due to falls or motor vehicle crashes.
Dr. Byrne had no disclosures.
SAN ANTONIO – Initiation of venous thromboembolism prophylaxis within 72 hours of severe traumatic brain injury (TBI) reduced the odds of venous thromboembolism by 50% without increasing subsequent intracranial complications or death in a large, propensity-matched cohort study from the University of Toronto.
The investigators matched 1,234 adult patients given prophylaxis before 72 hours – the early-prophylaxis (EP) group – to 1,234 given prophylaxis at 72 hours or later – the late-prophylaxis (LP) group – based on demographics, injury characteristics, intracranial lesions, early neurosurgical procedures, and prophylaxis type.
EP patients had a significantly lower rate of pulmonary embolism (1.1% vs. 2.4%; odds ratio, 0.48; 95% confidence interval, 0.25-0.91) and deep vein thrombosis (4.2% vs. 7.9%; OR, 0.51; 95% CI, 0.36-0.72), with no significant increase in the risk of death (9.8% EP vs. 9% LP; OR, 1.1; 95% CI 0.84-1.4) or late secondary craniotomy/-ectomy (EP 2.5% vs. LP 2.9%; OR, 0.86; 95% CI 0.53-1.4) or intracranial monitoring/drainage (EP 1.1% vs. LP 1.4%; OR, 0.76; 95% CI 0.37-1.6) from VTE complications or other reasons.
“Practice guidelines say we should initiate VTE [venous thromboembolism] prophylaxis” in severe TBI “as early as possible. It’s a very loose recommendation,” so some centers wait 72 hours or longer for fear of extending intracranial hemorrhages. Pending results from prospective trials, “our study lends evidence that early prophylaxis in this population may be safe,” said investigator and University of Toronto general surgery resident, Dr. James Byrne.
The study included 3,634 severe, adult TBI patients in the American College of Surgeons Trauma Quality Improvement Program database from 2012-2014. The subjects had head Abbreviated Injury Scale (AIS) scores of at least 3, Glasgow Coma Scale scores of no more than 8, and, in almost all cases, initial surgeries within 48 hours. Injury was due to blunt trauma. Patients who died or were discharged within 5 days of their injury and those with severe injuries to other body areas were excluded from the analysis.
The median time to starting VTE prophylaxis was 84 hours across the 186 trauma centers in the study, but ranged from 48-150 hours. Centers started prophylaxis within 72 hours in 18%-54% of patients. Fifty-five percent of patients had prophylaxis with low-molecular-weight heparin, and the rest with unfractionated heparin. Overall, 1.7% of patients developed pulmonary emboli, and 6.5% deep vein thromboses. Less than 3% had secondary neurosurgical interventions.
Prophylaxis was more likely to be delayed past 72 hours in patients with higher head AIS scores; subdural hematomas; subarachnoid hemorrhages; blood transfusions within 12 hours of admission; and early neurosurgery. Low-molecular-weight heparin was the more likely option past 72 hours.
Among the 114 centers who treated 10 or more patients, there was a continuous trend toward lower VTE rates with higher EP use, a rate of 9.1% in centers using EP in 18% of patients, but 6.1% in centers using it in 54% (P = .126).
The decision of when to start prophylaxis in severe TBI “still needs to be made at the patient level, but it may be safe to start earlier than 72 hours,” Dr. Byrne said.
The median age in the study was about 43 years, and three-quarters of the subjects were men. Most of the injuries were due to falls or motor vehicle crashes.
Dr. Byrne had no disclosures.
AT THE EAST SCIENTIFIC ASSEMBLY
Key clinical point: VTE prophylaxis within 72 hours appears to be safe in patients with TBI.
Major finding: Patients who had prophylaxis within 72 hours had a significantly lower rate of pulmonary embolism, compared with those started later (1.1% vs. 2.4%); and deep vein thrombosis (4.2% vs. 7.9%).
Data source: More than 2,000 patients in a propensity-matched cohort study from the University of Toronto.
Disclosures: Dr. Byrne had no disclosures.
Study eyes impact of blood pressure on survival in TBI
SAN DIEGO – In the setting of traumatic brain injury, increases in systolic blood pressure after the nadir are independently associated with improved survival in hypotensive patients.
In addition, even substantial blood pressure increases do not seem to harm normotensive patients. These findings come from a subanalysis of the ongoing National Institutes of Health–funded Excellence in Prehospital Injury Care (EPIC) TBI study.
“Very little is known about the patterns of blood pressure in traumatic brain injury in the field,” principal investigator Dr. Daniel W. Spaite said at the annual meeting of the National Association of EMS Physicians. “For instance, nobody knows whether it’s better to have your blood pressure increasing, stable, or decreasing in the field with regard to outcome, especially mortality. Typical studies that do have EMS data linked only have a single blood pressure measurement documented, so there’s no knowledge of trends in EMS blood pressure in TBI.”
Dr. Spaite, professor and Virginia Piper Endowed Chair of Emergency Medicine at the University of Arizona, Tucson, and his colleagues evaluated the association between mortality and increases in prehospital systolic blood pressure after the lowest recorded measurement in major TBI patients who are part of the EPIC study – the statewide implementation of TBI guidelines from the Brain Trauma Foundation and the NAEMSP. Data sources include the Arizona State Trauma Registry, which has comprehensive hospital outcome data. “The cases are then linked and the EMS patient care reports are carefully abstracted by the EPIC data team,” Dr. Spaite explained. “This included major TBI (which is, clinically, both moderate and severe) and all patients whose lowest systolic BP was between 40 and 300 mm Hg.”
The researchers used logistic regression to examine the association between the increase in EMS systolic blood pressure (SBP) after the lowest EMS blood pressure and its association with adjusted probability of death. They then partitioned the study population into four cohorts based on each patient’s prehospital systolic BP (40-89 mm Hg, 90-139 mm Hg, 140-159 mm Hg, and 160-300 mm Hg). In each cohort, they identified the independent association between the magnitude of increase in SBP and the adjusted probability of death.
Dr. Spaite reported findings from 14,567 TBI patients. More than two-thirds (68%) were male, and their mean age was 45 years. The researchers observed that, in the hypotensive cohort, mortality dropped significantly if the SBP increased after the lowest SBP. “Improvements were dramatic with increases of 40-80 mm Hg,” he said. In the normotensive group, increases in SBP were associated with very slight reductions in mortality. Even large increases in SBP, such as in the range of 70-90 mm Hg, did not appear to be detrimental.
In the mildly hypertensive group, large systolic increases were associated with higher mortality. “Interestingly, even if your lowest [SBP] is between 140 and 159 mm Hg, until you get above an increase of 40 mm Hg above that, you don’t start seeing increases in mortality,” Dr. Spaite said. In the severely hypertensive group, mortality was higher with any subsequent increase in SBP, “which doesn’t surprise any of us,” he said. “It’s dramatically higher if the increase is large.”
Dr. Spaite emphasized that the current analysis is based on observational data, “so this does not prove that treating hypotension improves outcome. … That direct question is part of the EPIC study itself and awaits the final analysis, hopefully in mid-2017. This is the first large report of blood pressure trends in the prehospital management of TBI.”
He concluded that the current findings in the hypotensive and normotensive cohorts “support guideline recommendations for restoring and optimizing cerebral perfusion in EMS traumatic brain injury management. What is fascinating about the literature is that the focus in TBI has always been on hypotension, but there’s very little information about what’s the best or the optimal blood pressure.”
EPIC is funded by the National Institutes of Health. Dr. Spaite reported having no relevant financial disclosures.
SAN DIEGO – In the setting of traumatic brain injury, increases in systolic blood pressure after the nadir are independently associated with improved survival in hypotensive patients.
In addition, even substantial blood pressure increases do not seem to harm normotensive patients. These findings come from a subanalysis of the ongoing National Institutes of Health–funded Excellence in Prehospital Injury Care (EPIC) TBI study.
“Very little is known about the patterns of blood pressure in traumatic brain injury in the field,” principal investigator Dr. Daniel W. Spaite said at the annual meeting of the National Association of EMS Physicians. “For instance, nobody knows whether it’s better to have your blood pressure increasing, stable, or decreasing in the field with regard to outcome, especially mortality. Typical studies that do have EMS data linked only have a single blood pressure measurement documented, so there’s no knowledge of trends in EMS blood pressure in TBI.”
Dr. Spaite, professor and Virginia Piper Endowed Chair of Emergency Medicine at the University of Arizona, Tucson, and his colleagues evaluated the association between mortality and increases in prehospital systolic blood pressure after the lowest recorded measurement in major TBI patients who are part of the EPIC study – the statewide implementation of TBI guidelines from the Brain Trauma Foundation and the NAEMSP. Data sources include the Arizona State Trauma Registry, which has comprehensive hospital outcome data. “The cases are then linked and the EMS patient care reports are carefully abstracted by the EPIC data team,” Dr. Spaite explained. “This included major TBI (which is, clinically, both moderate and severe) and all patients whose lowest systolic BP was between 40 and 300 mm Hg.”
The researchers used logistic regression to examine the association between the increase in EMS systolic blood pressure (SBP) after the lowest EMS blood pressure and its association with adjusted probability of death. They then partitioned the study population into four cohorts based on each patient’s prehospital systolic BP (40-89 mm Hg, 90-139 mm Hg, 140-159 mm Hg, and 160-300 mm Hg). In each cohort, they identified the independent association between the magnitude of increase in SBP and the adjusted probability of death.
Dr. Spaite reported findings from 14,567 TBI patients. More than two-thirds (68%) were male, and their mean age was 45 years. The researchers observed that, in the hypotensive cohort, mortality dropped significantly if the SBP increased after the lowest SBP. “Improvements were dramatic with increases of 40-80 mm Hg,” he said. In the normotensive group, increases in SBP were associated with very slight reductions in mortality. Even large increases in SBP, such as in the range of 70-90 mm Hg, did not appear to be detrimental.
In the mildly hypertensive group, large systolic increases were associated with higher mortality. “Interestingly, even if your lowest [SBP] is between 140 and 159 mm Hg, until you get above an increase of 40 mm Hg above that, you don’t start seeing increases in mortality,” Dr. Spaite said. In the severely hypertensive group, mortality was higher with any subsequent increase in SBP, “which doesn’t surprise any of us,” he said. “It’s dramatically higher if the increase is large.”
Dr. Spaite emphasized that the current analysis is based on observational data, “so this does not prove that treating hypotension improves outcome. … That direct question is part of the EPIC study itself and awaits the final analysis, hopefully in mid-2017. This is the first large report of blood pressure trends in the prehospital management of TBI.”
He concluded that the current findings in the hypotensive and normotensive cohorts “support guideline recommendations for restoring and optimizing cerebral perfusion in EMS traumatic brain injury management. What is fascinating about the literature is that the focus in TBI has always been on hypotension, but there’s very little information about what’s the best or the optimal blood pressure.”
EPIC is funded by the National Institutes of Health. Dr. Spaite reported having no relevant financial disclosures.
SAN DIEGO – In the setting of traumatic brain injury, increases in systolic blood pressure after the nadir are independently associated with improved survival in hypotensive patients.
In addition, even substantial blood pressure increases do not seem to harm normotensive patients. These findings come from a subanalysis of the ongoing National Institutes of Health–funded Excellence in Prehospital Injury Care (EPIC) TBI study.
“Very little is known about the patterns of blood pressure in traumatic brain injury in the field,” principal investigator Dr. Daniel W. Spaite said at the annual meeting of the National Association of EMS Physicians. “For instance, nobody knows whether it’s better to have your blood pressure increasing, stable, or decreasing in the field with regard to outcome, especially mortality. Typical studies that do have EMS data linked only have a single blood pressure measurement documented, so there’s no knowledge of trends in EMS blood pressure in TBI.”
Dr. Spaite, professor and Virginia Piper Endowed Chair of Emergency Medicine at the University of Arizona, Tucson, and his colleagues evaluated the association between mortality and increases in prehospital systolic blood pressure after the lowest recorded measurement in major TBI patients who are part of the EPIC study – the statewide implementation of TBI guidelines from the Brain Trauma Foundation and the NAEMSP. Data sources include the Arizona State Trauma Registry, which has comprehensive hospital outcome data. “The cases are then linked and the EMS patient care reports are carefully abstracted by the EPIC data team,” Dr. Spaite explained. “This included major TBI (which is, clinically, both moderate and severe) and all patients whose lowest systolic BP was between 40 and 300 mm Hg.”
The researchers used logistic regression to examine the association between the increase in EMS systolic blood pressure (SBP) after the lowest EMS blood pressure and its association with adjusted probability of death. They then partitioned the study population into four cohorts based on each patient’s prehospital systolic BP (40-89 mm Hg, 90-139 mm Hg, 140-159 mm Hg, and 160-300 mm Hg). In each cohort, they identified the independent association between the magnitude of increase in SBP and the adjusted probability of death.
Dr. Spaite reported findings from 14,567 TBI patients. More than two-thirds (68%) were male, and their mean age was 45 years. The researchers observed that, in the hypotensive cohort, mortality dropped significantly if the SBP increased after the lowest SBP. “Improvements were dramatic with increases of 40-80 mm Hg,” he said. In the normotensive group, increases in SBP were associated with very slight reductions in mortality. Even large increases in SBP, such as in the range of 70-90 mm Hg, did not appear to be detrimental.
In the mildly hypertensive group, large systolic increases were associated with higher mortality. “Interestingly, even if your lowest [SBP] is between 140 and 159 mm Hg, until you get above an increase of 40 mm Hg above that, you don’t start seeing increases in mortality,” Dr. Spaite said. In the severely hypertensive group, mortality was higher with any subsequent increase in SBP, “which doesn’t surprise any of us,” he said. “It’s dramatically higher if the increase is large.”
Dr. Spaite emphasized that the current analysis is based on observational data, “so this does not prove that treating hypotension improves outcome. … That direct question is part of the EPIC study itself and awaits the final analysis, hopefully in mid-2017. This is the first large report of blood pressure trends in the prehospital management of TBI.”
He concluded that the current findings in the hypotensive and normotensive cohorts “support guideline recommendations for restoring and optimizing cerebral perfusion in EMS traumatic brain injury management. What is fascinating about the literature is that the focus in TBI has always been on hypotension, but there’s very little information about what’s the best or the optimal blood pressure.”
EPIC is funded by the National Institutes of Health. Dr. Spaite reported having no relevant financial disclosures.
AT NAEMSP 2016
Key clinical point: The optimal systolic blood pressure in traumatic brain injury may be higher than previously thought.
Major finding: In the hypotensive cohort, mortality dropped significantly if the systolic blood pressure increased after the lowest SBP. In the normotensive group, increases in SBP were associated with very slight reductions in mortality.
Data source: An analysis of 14,567 TBI patients enrolled in the National Institutes of Health–funded Excellence in Prehospital Injury Care TBI Study.
Disclosures: EPIC is funded by NIH. Dr. Spaite reported having no relevant financial disclosures.
SF-6D best quality of life measure in cervical spine patients
SAN DIEGO – Among patients undergoing elective surgical spine procedures, the Short Form–6D derived from the Neck Disability Index was more valid and a better responsive measure of general health and quality of life, compared with the Short Form–6D derived from the Short Form–12 or the EuroQol-5D, results from a single-center study showed.
For such quality of life measures to be useful and meaningful, they “should be reproducible, responsive, economical, easy to use, and sensitive to responder burden,” Dr. John A. Sielatycki said at the annual meeting of the Cervical Spine Research Society.
“The EQ-5D is well established and commonly used in many of these studies, as is SF-6D, which in some cases has been shown to be more sensitive in certain disease states,” explained Dr. Sielatycki, a resident in the department of orthopedics at Vanderbilt University, Nashville, Tenn. “The differences between SF-6D and EQ-5D have been studied in a wide variety of disease conditions, but to our knowledge few have looked at this specifically in the setting of cervical spine operations.”
To analyze the validity and responsiveness of the SF-6D (derived from both the SF-12 and the NDI) and the EQ-5D in determining overall health and quality of life following elective cervical spine procedures, Dr. Sielatycki and his associates compared the three tools in 420 consecutive patients who presented over the course of 2 years. Trauma and workers’ compensation cases were excluded from the study, as were patients who had a tumor or an infection.
The researchers collected outcome measures at baseline, 3 months, 6 months, 12 months, and yearly thereafter, and defined meaningful improvement as having a North American Spine Society patient satisfaction score of 1, indicating the procedure “met the patient’s expectations.” Next, they generated receiver operating characteristic curves to discriminate between meaningful and nonmeaningful improvement.
The SF-6D (NDI) was a more valid discriminator of meaningful improvement, compared with the SF-6D (SF-12) or the EQ-5D (area under the curve of .69, .65, and .62, respectively). It was also a more responsive measure, compared with the SF-6D (SF-12) and the EQ-5D (standardized response means difference of .66, .48, and .44, respectively).
“Surgeons, outcomes researchers, and payers should use health metrics that are most responsive to changes in the particular disease in question,” Dr. Sielatycki said. “Based on this analysis, SF-6D derived from NDI may be a more valid and responsive measure of improvement in patients undergoing cervical procedures. We suggest that this metric be used in cost-effectiveness analysis and in calculating quality-adjusted life years for cervical spine patients.”
Dr. Sielatycki acknowledged certain limitations of the study, including the fact that it “should have some external validation done to further corroborate our findings. Our gold standard of meaningful improvement has not been established.”
Dr. Sielatycki reported having no financial disclosures.
SAN DIEGO – Among patients undergoing elective surgical spine procedures, the Short Form–6D derived from the Neck Disability Index was more valid and a better responsive measure of general health and quality of life, compared with the Short Form–6D derived from the Short Form–12 or the EuroQol-5D, results from a single-center study showed.
For such quality of life measures to be useful and meaningful, they “should be reproducible, responsive, economical, easy to use, and sensitive to responder burden,” Dr. John A. Sielatycki said at the annual meeting of the Cervical Spine Research Society.
“The EQ-5D is well established and commonly used in many of these studies, as is SF-6D, which in some cases has been shown to be more sensitive in certain disease states,” explained Dr. Sielatycki, a resident in the department of orthopedics at Vanderbilt University, Nashville, Tenn. “The differences between SF-6D and EQ-5D have been studied in a wide variety of disease conditions, but to our knowledge few have looked at this specifically in the setting of cervical spine operations.”
To analyze the validity and responsiveness of the SF-6D (derived from both the SF-12 and the NDI) and the EQ-5D in determining overall health and quality of life following elective cervical spine procedures, Dr. Sielatycki and his associates compared the three tools in 420 consecutive patients who presented over the course of 2 years. Trauma and workers’ compensation cases were excluded from the study, as were patients who had a tumor or an infection.
The researchers collected outcome measures at baseline, 3 months, 6 months, 12 months, and yearly thereafter, and defined meaningful improvement as having a North American Spine Society patient satisfaction score of 1, indicating the procedure “met the patient’s expectations.” Next, they generated receiver operating characteristic curves to discriminate between meaningful and nonmeaningful improvement.
The SF-6D (NDI) was a more valid discriminator of meaningful improvement, compared with the SF-6D (SF-12) or the EQ-5D (area under the curve of .69, .65, and .62, respectively). It was also a more responsive measure, compared with the SF-6D (SF-12) and the EQ-5D (standardized response means difference of .66, .48, and .44, respectively).
“Surgeons, outcomes researchers, and payers should use health metrics that are most responsive to changes in the particular disease in question,” Dr. Sielatycki said. “Based on this analysis, SF-6D derived from NDI may be a more valid and responsive measure of improvement in patients undergoing cervical procedures. We suggest that this metric be used in cost-effectiveness analysis and in calculating quality-adjusted life years for cervical spine patients.”
Dr. Sielatycki acknowledged certain limitations of the study, including the fact that it “should have some external validation done to further corroborate our findings. Our gold standard of meaningful improvement has not been established.”
Dr. Sielatycki reported having no financial disclosures.
SAN DIEGO – Among patients undergoing elective surgical spine procedures, the Short Form–6D derived from the Neck Disability Index was more valid and a better responsive measure of general health and quality of life, compared with the Short Form–6D derived from the Short Form–12 or the EuroQol-5D, results from a single-center study showed.
For such quality of life measures to be useful and meaningful, they “should be reproducible, responsive, economical, easy to use, and sensitive to responder burden,” Dr. John A. Sielatycki said at the annual meeting of the Cervical Spine Research Society.
“The EQ-5D is well established and commonly used in many of these studies, as is SF-6D, which in some cases has been shown to be more sensitive in certain disease states,” explained Dr. Sielatycki, a resident in the department of orthopedics at Vanderbilt University, Nashville, Tenn. “The differences between SF-6D and EQ-5D have been studied in a wide variety of disease conditions, but to our knowledge few have looked at this specifically in the setting of cervical spine operations.”
To analyze the validity and responsiveness of the SF-6D (derived from both the SF-12 and the NDI) and the EQ-5D in determining overall health and quality of life following elective cervical spine procedures, Dr. Sielatycki and his associates compared the three tools in 420 consecutive patients who presented over the course of 2 years. Trauma and workers’ compensation cases were excluded from the study, as were patients who had a tumor or an infection.
The researchers collected outcome measures at baseline, 3 months, 6 months, 12 months, and yearly thereafter, and defined meaningful improvement as having a North American Spine Society patient satisfaction score of 1, indicating the procedure “met the patient’s expectations.” Next, they generated receiver operating characteristic curves to discriminate between meaningful and nonmeaningful improvement.
The SF-6D (NDI) was a more valid discriminator of meaningful improvement, compared with the SF-6D (SF-12) or the EQ-5D (area under the curve of .69, .65, and .62, respectively). It was also a more responsive measure, compared with the SF-6D (SF-12) and the EQ-5D (standardized response means difference of .66, .48, and .44, respectively).
“Surgeons, outcomes researchers, and payers should use health metrics that are most responsive to changes in the particular disease in question,” Dr. Sielatycki said. “Based on this analysis, SF-6D derived from NDI may be a more valid and responsive measure of improvement in patients undergoing cervical procedures. We suggest that this metric be used in cost-effectiveness analysis and in calculating quality-adjusted life years for cervical spine patients.”
Dr. Sielatycki acknowledged certain limitations of the study, including the fact that it “should have some external validation done to further corroborate our findings. Our gold standard of meaningful improvement has not been established.”
Dr. Sielatycki reported having no financial disclosures.
AT CSRS 2015
Key clinical point: The Short Form–6D derived from the Neck Disability Index is an effective measure of outcomes in cervical spine patients.
Major finding: The Short Form–6D derived from the Neck Disability Index was a more valid discriminator of meaningful improvement, compared with the Short Form–6D derived from the Short Form–12 or the EuroQol-5D (AUC of .69, .65, and .62, respectively).
Data source: A single-center study that compared three quality of life measures in 420 patients presenting for elective surgical spine procedures.
Disclosures: Dr. Sielatycki reported having no financial disclosures.
Sugammadex OK’d to reverse neuromuscular blockade during surgery
The Food and Drug Administration approved on Dec. 15 Merck’s sugammadex (Bridion) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide during surgery.
The safety and efficacy of sugammadex were evaluated in three phase III trials involving 456 participants; most recovered within 5 minutes. An FDA review of the drug found that there was less residual neuromuscular blockade with sugammadex compared to neostigmine, and a 4-minute time savings to extubation and operating room discharge.
“Bridion provides a new treatment option that may help patients recover sooner from medications used for intubation or ventilation during surgery. This drug enables medical personnel to reverse the effects of neuromuscular blocking drugs and restore spontaneous breathing after surgery,” Dr. Sharon Hertz, director of the FDA’s Division of Anesthesia, Analgesia, and Addiction Products, said in a statement.
Although approved in other countries, sugammadex has been in the FDA’s review process since 2007, previously rejected and held up by concerns over anaphylaxis and other issues.
Because of that, sugammadex was further evaluated in a randomized, double-blind, parallel-group, repeat-dose trial. Of the 299 participants treated with Bridion, one person had an anaphylactic reaction. “Clinicians should be aware of the possibility of a hypersensitivity reaction or anaphylaxis and should intervene as appropriate,” the agency said in its statement.
Cases of marked bradycardia, some of which have resulted in cardiac arrest, have also been observed within minutes after the administration of Bridion. Tachycardia and bradycardia have been associated with cases of anaphylaxis. “Patients should be closely monitored for hemodynamic changes during and after reversal of neuromuscular blockade, and treatment with anticholinergic agents, such as atropine, should be administered if clinically significant bradycardia is observed,” the agency said.
The most common side effects reported in trials were vomiting, hypotension, pain, headache, and nausea. “Doctors should also advise women using hormonal contraceptives that Bridion may temporarily reduce the contraceptive effect so they must use an alternate method of birth control for a period of time,” the agency said.
Rocuronium bromide and vecuronium bromide are used to paralyze the vocal cords for tracheal intubation, as well as to paralyze patients under general anesthesia and prevent spontaneous breathing during ventilation. Sugammadex is a new molecular entity of the gamma-cyclodextrin class, designed to bind rocuronium and vecuronium.
The Food and Drug Administration approved on Dec. 15 Merck’s sugammadex (Bridion) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide during surgery.
The safety and efficacy of sugammadex were evaluated in three phase III trials involving 456 participants; most recovered within 5 minutes. An FDA review of the drug found that there was less residual neuromuscular blockade with sugammadex compared to neostigmine, and a 4-minute time savings to extubation and operating room discharge.
“Bridion provides a new treatment option that may help patients recover sooner from medications used for intubation or ventilation during surgery. This drug enables medical personnel to reverse the effects of neuromuscular blocking drugs and restore spontaneous breathing after surgery,” Dr. Sharon Hertz, director of the FDA’s Division of Anesthesia, Analgesia, and Addiction Products, said in a statement.
Although approved in other countries, sugammadex has been in the FDA’s review process since 2007, previously rejected and held up by concerns over anaphylaxis and other issues.
Because of that, sugammadex was further evaluated in a randomized, double-blind, parallel-group, repeat-dose trial. Of the 299 participants treated with Bridion, one person had an anaphylactic reaction. “Clinicians should be aware of the possibility of a hypersensitivity reaction or anaphylaxis and should intervene as appropriate,” the agency said in its statement.
Cases of marked bradycardia, some of which have resulted in cardiac arrest, have also been observed within minutes after the administration of Bridion. Tachycardia and bradycardia have been associated with cases of anaphylaxis. “Patients should be closely monitored for hemodynamic changes during and after reversal of neuromuscular blockade, and treatment with anticholinergic agents, such as atropine, should be administered if clinically significant bradycardia is observed,” the agency said.
The most common side effects reported in trials were vomiting, hypotension, pain, headache, and nausea. “Doctors should also advise women using hormonal contraceptives that Bridion may temporarily reduce the contraceptive effect so they must use an alternate method of birth control for a period of time,” the agency said.
Rocuronium bromide and vecuronium bromide are used to paralyze the vocal cords for tracheal intubation, as well as to paralyze patients under general anesthesia and prevent spontaneous breathing during ventilation. Sugammadex is a new molecular entity of the gamma-cyclodextrin class, designed to bind rocuronium and vecuronium.
The Food and Drug Administration approved on Dec. 15 Merck’s sugammadex (Bridion) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide during surgery.
The safety and efficacy of sugammadex were evaluated in three phase III trials involving 456 participants; most recovered within 5 minutes. An FDA review of the drug found that there was less residual neuromuscular blockade with sugammadex compared to neostigmine, and a 4-minute time savings to extubation and operating room discharge.
“Bridion provides a new treatment option that may help patients recover sooner from medications used for intubation or ventilation during surgery. This drug enables medical personnel to reverse the effects of neuromuscular blocking drugs and restore spontaneous breathing after surgery,” Dr. Sharon Hertz, director of the FDA’s Division of Anesthesia, Analgesia, and Addiction Products, said in a statement.
Although approved in other countries, sugammadex has been in the FDA’s review process since 2007, previously rejected and held up by concerns over anaphylaxis and other issues.
Because of that, sugammadex was further evaluated in a randomized, double-blind, parallel-group, repeat-dose trial. Of the 299 participants treated with Bridion, one person had an anaphylactic reaction. “Clinicians should be aware of the possibility of a hypersensitivity reaction or anaphylaxis and should intervene as appropriate,” the agency said in its statement.
Cases of marked bradycardia, some of which have resulted in cardiac arrest, have also been observed within minutes after the administration of Bridion. Tachycardia and bradycardia have been associated with cases of anaphylaxis. “Patients should be closely monitored for hemodynamic changes during and after reversal of neuromuscular blockade, and treatment with anticholinergic agents, such as atropine, should be administered if clinically significant bradycardia is observed,” the agency said.
The most common side effects reported in trials were vomiting, hypotension, pain, headache, and nausea. “Doctors should also advise women using hormonal contraceptives that Bridion may temporarily reduce the contraceptive effect so they must use an alternate method of birth control for a period of time,” the agency said.
Rocuronium bromide and vecuronium bromide are used to paralyze the vocal cords for tracheal intubation, as well as to paralyze patients under general anesthesia and prevent spontaneous breathing during ventilation. Sugammadex is a new molecular entity of the gamma-cyclodextrin class, designed to bind rocuronium and vecuronium.
Functional dependence linked to risk of complications after spine surgery
SAN DIEGO – Functional dependence following elective cervical spine procedures was associated with a significantly increased risk of almost all 30-day complications analyzed, including mortality, a large retrospective analysis of national data demonstrated.
The findings suggest that physicians should “include the patient’s level of functional independence, in addition to more traditional medical comorbidities, in the risk-benefit analysis of surgical decision making,” Dr. Alpesh A. Patel said in an interview in advance of the annual meeting of the Cervical Spine Research Society. “Those individuals with dependence need to be counseled appropriately about their increased risk of complications including mortality.”
Dr. Patel, professor and director of orthopedic spine surgery at Northwestern University Feinberg School of Medicine, Chicago, and his associates retrospectively reviewed the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) data files from 2006 to 2013 and limited their analysis to patients undergoing elective anterior cervical fusions, posterior cervical fusions, cervical laminectomy, cervical laminotomy, cervical discectomy, or corpectomy. They divided patients into one of three groups based on the following preoperative functional status parameters: independent, comprising those not requiring assistance or any equipment for activities of daily living (ADLs); partially dependent, including those with equipment such as prosthetics, equipment, or devices and requiring some assistance from another person for ADLs; and totally dependent, in which patients require total assistance for all ADLs. The researchers used univariate analysis to compare patient demographics, comorbidities, and 30-day postoperative complications among the three groups, followed by multivariate logistic regression to analyze the independent association of functional dependence on 30-day complications when controlling for procedure and comorbidity variances.
Dr. Patel reported findings from 24,357 patients: 23,620 (97.0%) functionally independent, 664 (2.7%) partially dependent, and 73 (0.3%) totally dependent. Dependent patients were significantly older and had higher rates of all comorbidities (P less than .001), with the exception of obesity (P = .214). In addition, 30-day complication rates were higher for all complications (P less than .001) other than neurological (P =.060) and surgical site complications (P =.668). When the researchers controlled for type of procedure and for disparities in patient preoperative variables, multivariate analyses demonstrated that functional dependence was independently associated with sepsis (odds ratio 6.40; P less than .001), pulmonary (OR 4.13; P less than .001), venous thromboembolism (OR 4.27, P less than .001), renal (OR 3.32; P less than .001), and cardiac complications (OR 4.68; P =.001), along with mortality (OR 8.31; P less than .001).
“The very strong association between functional dependence and mortality was quite surprising,” Dr. Patel said. “It was, to the contrary, also surprising to see that, despite wide variance in medical comorbidities and functional status, surgical complications such as infection and neurological injury were similar in all groups.” He characterized the study as “the first large-scale assessment of functional status as a predictor of patient outcomes after cervical spine surgery. It fits in line with other studies utilizing large databases. Big data analysis of outcomes can be used to identify risk factors for complications including death after surgery. Identifying these factors is important if we are going to improve the care we provide. Accurately quantifying the impact of these risk factors is also critical when we risk stratify and compare hospitals and physicians.”
He acknowledged certain limitations of the study, including the fact that it is a retrospective study “with a heterogeneous population of patients, surgeons, hospitals, and procedures. This adds uncertainty to the analysis at the level of the individual patient but does provide generalizability to a broader patient population.”
Dr. Patel reported having no conflicts of interest.
SAN DIEGO – Functional dependence following elective cervical spine procedures was associated with a significantly increased risk of almost all 30-day complications analyzed, including mortality, a large retrospective analysis of national data demonstrated.
The findings suggest that physicians should “include the patient’s level of functional independence, in addition to more traditional medical comorbidities, in the risk-benefit analysis of surgical decision making,” Dr. Alpesh A. Patel said in an interview in advance of the annual meeting of the Cervical Spine Research Society. “Those individuals with dependence need to be counseled appropriately about their increased risk of complications including mortality.”
Dr. Patel, professor and director of orthopedic spine surgery at Northwestern University Feinberg School of Medicine, Chicago, and his associates retrospectively reviewed the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) data files from 2006 to 2013 and limited their analysis to patients undergoing elective anterior cervical fusions, posterior cervical fusions, cervical laminectomy, cervical laminotomy, cervical discectomy, or corpectomy. They divided patients into one of three groups based on the following preoperative functional status parameters: independent, comprising those not requiring assistance or any equipment for activities of daily living (ADLs); partially dependent, including those with equipment such as prosthetics, equipment, or devices and requiring some assistance from another person for ADLs; and totally dependent, in which patients require total assistance for all ADLs. The researchers used univariate analysis to compare patient demographics, comorbidities, and 30-day postoperative complications among the three groups, followed by multivariate logistic regression to analyze the independent association of functional dependence on 30-day complications when controlling for procedure and comorbidity variances.
Dr. Patel reported findings from 24,357 patients: 23,620 (97.0%) functionally independent, 664 (2.7%) partially dependent, and 73 (0.3%) totally dependent. Dependent patients were significantly older and had higher rates of all comorbidities (P less than .001), with the exception of obesity (P = .214). In addition, 30-day complication rates were higher for all complications (P less than .001) other than neurological (P =.060) and surgical site complications (P =.668). When the researchers controlled for type of procedure and for disparities in patient preoperative variables, multivariate analyses demonstrated that functional dependence was independently associated with sepsis (odds ratio 6.40; P less than .001), pulmonary (OR 4.13; P less than .001), venous thromboembolism (OR 4.27, P less than .001), renal (OR 3.32; P less than .001), and cardiac complications (OR 4.68; P =.001), along with mortality (OR 8.31; P less than .001).
“The very strong association between functional dependence and mortality was quite surprising,” Dr. Patel said. “It was, to the contrary, also surprising to see that, despite wide variance in medical comorbidities and functional status, surgical complications such as infection and neurological injury were similar in all groups.” He characterized the study as “the first large-scale assessment of functional status as a predictor of patient outcomes after cervical spine surgery. It fits in line with other studies utilizing large databases. Big data analysis of outcomes can be used to identify risk factors for complications including death after surgery. Identifying these factors is important if we are going to improve the care we provide. Accurately quantifying the impact of these risk factors is also critical when we risk stratify and compare hospitals and physicians.”
He acknowledged certain limitations of the study, including the fact that it is a retrospective study “with a heterogeneous population of patients, surgeons, hospitals, and procedures. This adds uncertainty to the analysis at the level of the individual patient but does provide generalizability to a broader patient population.”
Dr. Patel reported having no conflicts of interest.
SAN DIEGO – Functional dependence following elective cervical spine procedures was associated with a significantly increased risk of almost all 30-day complications analyzed, including mortality, a large retrospective analysis of national data demonstrated.
The findings suggest that physicians should “include the patient’s level of functional independence, in addition to more traditional medical comorbidities, in the risk-benefit analysis of surgical decision making,” Dr. Alpesh A. Patel said in an interview in advance of the annual meeting of the Cervical Spine Research Society. “Those individuals with dependence need to be counseled appropriately about their increased risk of complications including mortality.”
Dr. Patel, professor and director of orthopedic spine surgery at Northwestern University Feinberg School of Medicine, Chicago, and his associates retrospectively reviewed the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) data files from 2006 to 2013 and limited their analysis to patients undergoing elective anterior cervical fusions, posterior cervical fusions, cervical laminectomy, cervical laminotomy, cervical discectomy, or corpectomy. They divided patients into one of three groups based on the following preoperative functional status parameters: independent, comprising those not requiring assistance or any equipment for activities of daily living (ADLs); partially dependent, including those with equipment such as prosthetics, equipment, or devices and requiring some assistance from another person for ADLs; and totally dependent, in which patients require total assistance for all ADLs. The researchers used univariate analysis to compare patient demographics, comorbidities, and 30-day postoperative complications among the three groups, followed by multivariate logistic regression to analyze the independent association of functional dependence on 30-day complications when controlling for procedure and comorbidity variances.
Dr. Patel reported findings from 24,357 patients: 23,620 (97.0%) functionally independent, 664 (2.7%) partially dependent, and 73 (0.3%) totally dependent. Dependent patients were significantly older and had higher rates of all comorbidities (P less than .001), with the exception of obesity (P = .214). In addition, 30-day complication rates were higher for all complications (P less than .001) other than neurological (P =.060) and surgical site complications (P =.668). When the researchers controlled for type of procedure and for disparities in patient preoperative variables, multivariate analyses demonstrated that functional dependence was independently associated with sepsis (odds ratio 6.40; P less than .001), pulmonary (OR 4.13; P less than .001), venous thromboembolism (OR 4.27, P less than .001), renal (OR 3.32; P less than .001), and cardiac complications (OR 4.68; P =.001), along with mortality (OR 8.31; P less than .001).
“The very strong association between functional dependence and mortality was quite surprising,” Dr. Patel said. “It was, to the contrary, also surprising to see that, despite wide variance in medical comorbidities and functional status, surgical complications such as infection and neurological injury were similar in all groups.” He characterized the study as “the first large-scale assessment of functional status as a predictor of patient outcomes after cervical spine surgery. It fits in line with other studies utilizing large databases. Big data analysis of outcomes can be used to identify risk factors for complications including death after surgery. Identifying these factors is important if we are going to improve the care we provide. Accurately quantifying the impact of these risk factors is also critical when we risk stratify and compare hospitals and physicians.”
He acknowledged certain limitations of the study, including the fact that it is a retrospective study “with a heterogeneous population of patients, surgeons, hospitals, and procedures. This adds uncertainty to the analysis at the level of the individual patient but does provide generalizability to a broader patient population.”
Dr. Patel reported having no conflicts of interest.
AT CSRS 2015
Key clinical point: Preoperative functional status is predictive of morbidity and mortality following elective cervical spine surgery.
Major finding: Patients who were dependent from a functional standpoint were significantly older and had higher rates of all comorbidities, compared with their counterparts who were partially dependent or functionally independent (P less than .001).
Data source: A retrospective analysis of 24,357 patient files from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP).
Disclosures: Dr. Patel reported having no conflicts of interest.
Study characterizes injury risk in cervical myelopathy patients
SAN DIEGO – Compared with age-matched controls, patients with cervical spondylotic myelopathy had a significantly increased incidence of falls, hip fractures, and other injuries, preliminary results from a study of Medicare data suggest.
“Cervical myelopathy is the most common cause of spinal cord dysfunction in patients over age 55,” Dr. Daniel J. Blizzard said at the annual meeting of the Cervical Spine Research Society. “In general, it’s cord compression secondary to their ossification of posterior latitudinal ligament, congenital stenosis, and/or degenerative changes to vertebral bodies, discs, and facet joints. These create an upper motor neuron lesion, which causes gait disturbances, imbalance, loss of manual dexterity and coordination, and sensory changes and weakness.”
Dr. Blizzard, an orthopedic surgery resident at Duke University, Durham, N.C., noted that myelopathy gait is the most common presenting symptom in cervical spondylotic myelopathy (CSM), affecting almost 30% of patients. “It’s present in three-quarters of CSM patients undergoing decompression,” he said. “Cord compression can lead to impaired proprioception, spasticity, and stiffness. We know that this gait dysfunction is multifactorial. Imbalance and unsteadiness lead to compensatory broad-based arrhythmic shuffling and clumsy-appearing gait to maintain balance.”
An estimated one-third of people over age 65 fall at least once per year and this may lead to significant morbidity, including institutionalization, loss of independence, and mortality, Dr. Blizzard continued. “We know that gait dysfunction is a significant risk factor for falls,” he said. “This can be CSM, lower extremity osteoarthritis, deconditioning, or poor vision. The primary cause of a gait disturbance may not be accurately identified, especially if a more obvious cause is already known.”
The researchers set out to determine the fall and injury risk of patients with CSM, “with the goal of guiding attention to what we thought might be a potentially underestimated disease with regard to morbidity, and to provide data to consider when determining the type and timing of CSM treatment,” Dr. Blizzard said. They used the PearlDiver database to search the Medicare sample during 2005-2012, and used ICD-9 codes to identify patients with CSM. They also identified a subpopulation of CSM patients that underwent decompression, “not for the purpose of comparing the effect of decompression, but to identify a population with more severe disease,” he explained. They included a control population with no CSM, vestibular disease, or Parkinson’s disease.
Dr. Blizzard reported preliminary results from a total of 601,390 patients with CSM, 77,346 patients with CSM plus decompression, and 49,550,651 controls. They looked at the incidence of falls, head injuries, skull fractures, subdural hematomas, and other orthopedic injuries including fractures of the hip, femur, leg, ankle, pelvis, and lower extremity sprains. The researchers found that when compared with controls, patients with CSM had a statistically significant increased incidence of all injuries, including hip fracture (risk ratio, 2.62), head injury (RR, 7.34), and fall (RR, 8.08). The incidence of hip fracture, head injury, and fall was also increased among the subset of CSM patients who had undergone decompression (RR of 2.25, 8.34, and 9.62, respectively).
Dr. Blizzard acknowledged certain limitations of the study, including its retrospective design. “Statistical and clinical significance are two very different things,” he emphasized. “When we get numbers this big, everything will become statistically significant, but whether things are clinically significant is up to interpretation. The presence of disease and complications is contingent upon proper coding and recognition by providers. We have no measures of severity, extent, or chronicity of disease.”
Despite such limitations, he concluded that the findings suggest that impact of CSM on morbidity “is probably underestimated by many. Symptoms of CSM can be insidious or masked. Patients can often attribute these to normal effects of aging, and often primary care physicians will not recognize these initial symptoms, especially if there is another confounding presenting complaint.”
Conservative interventions for CSM patients, he said, include gait training/physical therapy, assistive aids, hip pads, exercise programs with balance training, and an assessment of hazards in the home environment. From a surgical standpoint, the findings raise the possibility that surgeons may want to “be more aggressive” in their decision to operate on patients with CSM. “This dataset is in no way able to address this question, but I think it provides interesting information regarding the true morbidity of the disease,” Dr. Blizzard said. “There is clear risk and morbidity with cervical compression. Studies show improvement in patients regardless of age, severity, and chronicity.”
Dr. Blizzard reported having no financial disclosures.
SAN DIEGO – Compared with age-matched controls, patients with cervical spondylotic myelopathy had a significantly increased incidence of falls, hip fractures, and other injuries, preliminary results from a study of Medicare data suggest.
“Cervical myelopathy is the most common cause of spinal cord dysfunction in patients over age 55,” Dr. Daniel J. Blizzard said at the annual meeting of the Cervical Spine Research Society. “In general, it’s cord compression secondary to their ossification of posterior latitudinal ligament, congenital stenosis, and/or degenerative changes to vertebral bodies, discs, and facet joints. These create an upper motor neuron lesion, which causes gait disturbances, imbalance, loss of manual dexterity and coordination, and sensory changes and weakness.”
Dr. Blizzard, an orthopedic surgery resident at Duke University, Durham, N.C., noted that myelopathy gait is the most common presenting symptom in cervical spondylotic myelopathy (CSM), affecting almost 30% of patients. “It’s present in three-quarters of CSM patients undergoing decompression,” he said. “Cord compression can lead to impaired proprioception, spasticity, and stiffness. We know that this gait dysfunction is multifactorial. Imbalance and unsteadiness lead to compensatory broad-based arrhythmic shuffling and clumsy-appearing gait to maintain balance.”
An estimated one-third of people over age 65 fall at least once per year and this may lead to significant morbidity, including institutionalization, loss of independence, and mortality, Dr. Blizzard continued. “We know that gait dysfunction is a significant risk factor for falls,” he said. “This can be CSM, lower extremity osteoarthritis, deconditioning, or poor vision. The primary cause of a gait disturbance may not be accurately identified, especially if a more obvious cause is already known.”
The researchers set out to determine the fall and injury risk of patients with CSM, “with the goal of guiding attention to what we thought might be a potentially underestimated disease with regard to morbidity, and to provide data to consider when determining the type and timing of CSM treatment,” Dr. Blizzard said. They used the PearlDiver database to search the Medicare sample during 2005-2012, and used ICD-9 codes to identify patients with CSM. They also identified a subpopulation of CSM patients that underwent decompression, “not for the purpose of comparing the effect of decompression, but to identify a population with more severe disease,” he explained. They included a control population with no CSM, vestibular disease, or Parkinson’s disease.
Dr. Blizzard reported preliminary results from a total of 601,390 patients with CSM, 77,346 patients with CSM plus decompression, and 49,550,651 controls. They looked at the incidence of falls, head injuries, skull fractures, subdural hematomas, and other orthopedic injuries including fractures of the hip, femur, leg, ankle, pelvis, and lower extremity sprains. The researchers found that when compared with controls, patients with CSM had a statistically significant increased incidence of all injuries, including hip fracture (risk ratio, 2.62), head injury (RR, 7.34), and fall (RR, 8.08). The incidence of hip fracture, head injury, and fall was also increased among the subset of CSM patients who had undergone decompression (RR of 2.25, 8.34, and 9.62, respectively).
Dr. Blizzard acknowledged certain limitations of the study, including its retrospective design. “Statistical and clinical significance are two very different things,” he emphasized. “When we get numbers this big, everything will become statistically significant, but whether things are clinically significant is up to interpretation. The presence of disease and complications is contingent upon proper coding and recognition by providers. We have no measures of severity, extent, or chronicity of disease.”
Despite such limitations, he concluded that the findings suggest that impact of CSM on morbidity “is probably underestimated by many. Symptoms of CSM can be insidious or masked. Patients can often attribute these to normal effects of aging, and often primary care physicians will not recognize these initial symptoms, especially if there is another confounding presenting complaint.”
Conservative interventions for CSM patients, he said, include gait training/physical therapy, assistive aids, hip pads, exercise programs with balance training, and an assessment of hazards in the home environment. From a surgical standpoint, the findings raise the possibility that surgeons may want to “be more aggressive” in their decision to operate on patients with CSM. “This dataset is in no way able to address this question, but I think it provides interesting information regarding the true morbidity of the disease,” Dr. Blizzard said. “There is clear risk and morbidity with cervical compression. Studies show improvement in patients regardless of age, severity, and chronicity.”
Dr. Blizzard reported having no financial disclosures.
SAN DIEGO – Compared with age-matched controls, patients with cervical spondylotic myelopathy had a significantly increased incidence of falls, hip fractures, and other injuries, preliminary results from a study of Medicare data suggest.
“Cervical myelopathy is the most common cause of spinal cord dysfunction in patients over age 55,” Dr. Daniel J. Blizzard said at the annual meeting of the Cervical Spine Research Society. “In general, it’s cord compression secondary to their ossification of posterior latitudinal ligament, congenital stenosis, and/or degenerative changes to vertebral bodies, discs, and facet joints. These create an upper motor neuron lesion, which causes gait disturbances, imbalance, loss of manual dexterity and coordination, and sensory changes and weakness.”
Dr. Blizzard, an orthopedic surgery resident at Duke University, Durham, N.C., noted that myelopathy gait is the most common presenting symptom in cervical spondylotic myelopathy (CSM), affecting almost 30% of patients. “It’s present in three-quarters of CSM patients undergoing decompression,” he said. “Cord compression can lead to impaired proprioception, spasticity, and stiffness. We know that this gait dysfunction is multifactorial. Imbalance and unsteadiness lead to compensatory broad-based arrhythmic shuffling and clumsy-appearing gait to maintain balance.”
An estimated one-third of people over age 65 fall at least once per year and this may lead to significant morbidity, including institutionalization, loss of independence, and mortality, Dr. Blizzard continued. “We know that gait dysfunction is a significant risk factor for falls,” he said. “This can be CSM, lower extremity osteoarthritis, deconditioning, or poor vision. The primary cause of a gait disturbance may not be accurately identified, especially if a more obvious cause is already known.”
The researchers set out to determine the fall and injury risk of patients with CSM, “with the goal of guiding attention to what we thought might be a potentially underestimated disease with regard to morbidity, and to provide data to consider when determining the type and timing of CSM treatment,” Dr. Blizzard said. They used the PearlDiver database to search the Medicare sample during 2005-2012, and used ICD-9 codes to identify patients with CSM. They also identified a subpopulation of CSM patients that underwent decompression, “not for the purpose of comparing the effect of decompression, but to identify a population with more severe disease,” he explained. They included a control population with no CSM, vestibular disease, or Parkinson’s disease.
Dr. Blizzard reported preliminary results from a total of 601,390 patients with CSM, 77,346 patients with CSM plus decompression, and 49,550,651 controls. They looked at the incidence of falls, head injuries, skull fractures, subdural hematomas, and other orthopedic injuries including fractures of the hip, femur, leg, ankle, pelvis, and lower extremity sprains. The researchers found that when compared with controls, patients with CSM had a statistically significant increased incidence of all injuries, including hip fracture (risk ratio, 2.62), head injury (RR, 7.34), and fall (RR, 8.08). The incidence of hip fracture, head injury, and fall was also increased among the subset of CSM patients who had undergone decompression (RR of 2.25, 8.34, and 9.62, respectively).
Dr. Blizzard acknowledged certain limitations of the study, including its retrospective design. “Statistical and clinical significance are two very different things,” he emphasized. “When we get numbers this big, everything will become statistically significant, but whether things are clinically significant is up to interpretation. The presence of disease and complications is contingent upon proper coding and recognition by providers. We have no measures of severity, extent, or chronicity of disease.”
Despite such limitations, he concluded that the findings suggest that impact of CSM on morbidity “is probably underestimated by many. Symptoms of CSM can be insidious or masked. Patients can often attribute these to normal effects of aging, and often primary care physicians will not recognize these initial symptoms, especially if there is another confounding presenting complaint.”
Conservative interventions for CSM patients, he said, include gait training/physical therapy, assistive aids, hip pads, exercise programs with balance training, and an assessment of hazards in the home environment. From a surgical standpoint, the findings raise the possibility that surgeons may want to “be more aggressive” in their decision to operate on patients with CSM. “This dataset is in no way able to address this question, but I think it provides interesting information regarding the true morbidity of the disease,” Dr. Blizzard said. “There is clear risk and morbidity with cervical compression. Studies show improvement in patients regardless of age, severity, and chronicity.”
Dr. Blizzard reported having no financial disclosures.
AT CSRS 2015
Key clinical point: Medicare patients with cervical spondylotic myelopathy face an increased risk of falls and fractures.
Major finding: Compared with controls, patients with CSM had a statistically significant increased incidence of all injuries, including hip fracture (risk ratio, 2.62), head injury (RR, 7.34), and fall (RR, 8.08).
Data source: A retrospective analysis of Medicare patients during 2005-2012, including 601,390 patients with CSM, 77,346 patients with CSM plus decompression, and 49,550,651 controls.
Disclosures: Dr. Blizzard reported having no financial disclosures.
Glial fibrillary acidic protein may help identify youth with TBI
Glial fibrillary acidic protein appears to be a candidate biomarker for detecting traumatic intracranial lesions on head CT after mild to moderate head trauma in youth, a study showed.
Previous studies have found that head CT scans in children less than 5 years old may contribute to the risk for brain cancer and leukemia because children are more sensitive to ionizing radiation. Ninety-nine different pediatric biomarkers have been researched for traumatic brain injury (TBI); some studies have indicated glial fibrillary acidic protein (GFAP) may be a promising biomarker for mild to moderate TBI in adults.
Dr. Linda Papa of the department of emergency medicine at Orlando Regional Medical Center and colleagues compared the GFAP level in the serum of children and youth evaluated for mild to moderate TBI with pediatric trauma patients without brain injury to see how these levels were related to evidence of traumatic lesions on head CT. Their results were published in Academic Emergency Medicine (2015 Nov;22[11]:1274-82. doi: 10.1111/acem.12795).
They conducted a prospective cohort study of 197 children and youth who presented with a Glasgow Coma Scale (GCS) score of 9-15 after blunt head trauma. The 60 control patients included those without head trauma and a GSC score of 15. A head CT scan was obtained in 152 patients, with 11% demonstrating traumatic intracranial lesions. Serum samples were drawn within 6 hours of injury, at a mean 3.3 hours in those with head injury and 4.1 hours in those without head injury.
Children with traumatic intracranial lesions on CT scan had higher median GFAP levels (1.01, interquartile range = 0.59-1.48), compared with those without lesions on CT (0.18, IQR = 0.06-0.47).
When GFAP was used to detect traumatic lesions on head CT, the area under the receiver operating characteristic curve (AUC) was 0.82 (95% confidence interval, 0.71-0.93); it was 0.80 (95% CI, 0.68-0.92) for those with a GCS of 15, and 0.83 (95% CI, 0.56-1.00) in those younger than 5 years old.
Using a cutoff level of 0.15 ng/mL for GFAP, Dr. Papa and colleagues noted a negative predictive value of 98%, a specificity of 47%, and a sensitivity of 94% for detecting intracranial lesions.
Several limitations to the study included not having research assistants available to enroll participants 24/7, a lack of long-term outcome data, and a small cohort without any participants requiring neurosurgical intervention.
The next steps would involve clinical validation with a large, multicenter study.
This study was supported by an award from the National Institute of Neurological Disorders and Stroke. Dr. Papa reported consulting for Banyan Biomarkers.
Out of the 99 markers studied previously, glial fibrillary acidic protein appears to be the most promising in adults. The authors wanted to examine its usefulness in children.
Dr. Gregory L. Landry |
This serum marker may be helpful to clinicians in deciding who needs a CT scan and who does not, but a larger study is still needed.
Serum markers seem to be most useful in patients with moderate to severe head trauma. The typical sports concussion (mild traumatic brain injury) does not cause enough damage to raise serum markers, and so far studies of markers in that group have shown that they are not helpful in determining severity of the injury.
Dr. Gregory L. Landry is affiliated with the University of Wisconsin–Madison, specializing in pediatric and adolescent primary care sports medicine. These comments were taken from an interview with Dr. Landry, who said he had no relevant financial disclosures.
Out of the 99 markers studied previously, glial fibrillary acidic protein appears to be the most promising in adults. The authors wanted to examine its usefulness in children.
Dr. Gregory L. Landry |
This serum marker may be helpful to clinicians in deciding who needs a CT scan and who does not, but a larger study is still needed.
Serum markers seem to be most useful in patients with moderate to severe head trauma. The typical sports concussion (mild traumatic brain injury) does not cause enough damage to raise serum markers, and so far studies of markers in that group have shown that they are not helpful in determining severity of the injury.
Dr. Gregory L. Landry is affiliated with the University of Wisconsin–Madison, specializing in pediatric and adolescent primary care sports medicine. These comments were taken from an interview with Dr. Landry, who said he had no relevant financial disclosures.
Out of the 99 markers studied previously, glial fibrillary acidic protein appears to be the most promising in adults. The authors wanted to examine its usefulness in children.
Dr. Gregory L. Landry |
This serum marker may be helpful to clinicians in deciding who needs a CT scan and who does not, but a larger study is still needed.
Serum markers seem to be most useful in patients with moderate to severe head trauma. The typical sports concussion (mild traumatic brain injury) does not cause enough damage to raise serum markers, and so far studies of markers in that group have shown that they are not helpful in determining severity of the injury.
Dr. Gregory L. Landry is affiliated with the University of Wisconsin–Madison, specializing in pediatric and adolescent primary care sports medicine. These comments were taken from an interview with Dr. Landry, who said he had no relevant financial disclosures.
Glial fibrillary acidic protein appears to be a candidate biomarker for detecting traumatic intracranial lesions on head CT after mild to moderate head trauma in youth, a study showed.
Previous studies have found that head CT scans in children less than 5 years old may contribute to the risk for brain cancer and leukemia because children are more sensitive to ionizing radiation. Ninety-nine different pediatric biomarkers have been researched for traumatic brain injury (TBI); some studies have indicated glial fibrillary acidic protein (GFAP) may be a promising biomarker for mild to moderate TBI in adults.
Dr. Linda Papa of the department of emergency medicine at Orlando Regional Medical Center and colleagues compared the GFAP level in the serum of children and youth evaluated for mild to moderate TBI with pediatric trauma patients without brain injury to see how these levels were related to evidence of traumatic lesions on head CT. Their results were published in Academic Emergency Medicine (2015 Nov;22[11]:1274-82. doi: 10.1111/acem.12795).
They conducted a prospective cohort study of 197 children and youth who presented with a Glasgow Coma Scale (GCS) score of 9-15 after blunt head trauma. The 60 control patients included those without head trauma and a GSC score of 15. A head CT scan was obtained in 152 patients, with 11% demonstrating traumatic intracranial lesions. Serum samples were drawn within 6 hours of injury, at a mean 3.3 hours in those with head injury and 4.1 hours in those without head injury.
Children with traumatic intracranial lesions on CT scan had higher median GFAP levels (1.01, interquartile range = 0.59-1.48), compared with those without lesions on CT (0.18, IQR = 0.06-0.47).
When GFAP was used to detect traumatic lesions on head CT, the area under the receiver operating characteristic curve (AUC) was 0.82 (95% confidence interval, 0.71-0.93); it was 0.80 (95% CI, 0.68-0.92) for those with a GCS of 15, and 0.83 (95% CI, 0.56-1.00) in those younger than 5 years old.
Using a cutoff level of 0.15 ng/mL for GFAP, Dr. Papa and colleagues noted a negative predictive value of 98%, a specificity of 47%, and a sensitivity of 94% for detecting intracranial lesions.
Several limitations to the study included not having research assistants available to enroll participants 24/7, a lack of long-term outcome data, and a small cohort without any participants requiring neurosurgical intervention.
The next steps would involve clinical validation with a large, multicenter study.
This study was supported by an award from the National Institute of Neurological Disorders and Stroke. Dr. Papa reported consulting for Banyan Biomarkers.
Glial fibrillary acidic protein appears to be a candidate biomarker for detecting traumatic intracranial lesions on head CT after mild to moderate head trauma in youth, a study showed.
Previous studies have found that head CT scans in children less than 5 years old may contribute to the risk for brain cancer and leukemia because children are more sensitive to ionizing radiation. Ninety-nine different pediatric biomarkers have been researched for traumatic brain injury (TBI); some studies have indicated glial fibrillary acidic protein (GFAP) may be a promising biomarker for mild to moderate TBI in adults.
Dr. Linda Papa of the department of emergency medicine at Orlando Regional Medical Center and colleagues compared the GFAP level in the serum of children and youth evaluated for mild to moderate TBI with pediatric trauma patients without brain injury to see how these levels were related to evidence of traumatic lesions on head CT. Their results were published in Academic Emergency Medicine (2015 Nov;22[11]:1274-82. doi: 10.1111/acem.12795).
They conducted a prospective cohort study of 197 children and youth who presented with a Glasgow Coma Scale (GCS) score of 9-15 after blunt head trauma. The 60 control patients included those without head trauma and a GSC score of 15. A head CT scan was obtained in 152 patients, with 11% demonstrating traumatic intracranial lesions. Serum samples were drawn within 6 hours of injury, at a mean 3.3 hours in those with head injury and 4.1 hours in those without head injury.
Children with traumatic intracranial lesions on CT scan had higher median GFAP levels (1.01, interquartile range = 0.59-1.48), compared with those without lesions on CT (0.18, IQR = 0.06-0.47).
When GFAP was used to detect traumatic lesions on head CT, the area under the receiver operating characteristic curve (AUC) was 0.82 (95% confidence interval, 0.71-0.93); it was 0.80 (95% CI, 0.68-0.92) for those with a GCS of 15, and 0.83 (95% CI, 0.56-1.00) in those younger than 5 years old.
Using a cutoff level of 0.15 ng/mL for GFAP, Dr. Papa and colleagues noted a negative predictive value of 98%, a specificity of 47%, and a sensitivity of 94% for detecting intracranial lesions.
Several limitations to the study included not having research assistants available to enroll participants 24/7, a lack of long-term outcome data, and a small cohort without any participants requiring neurosurgical intervention.
The next steps would involve clinical validation with a large, multicenter study.
This study was supported by an award from the National Institute of Neurological Disorders and Stroke. Dr. Papa reported consulting for Banyan Biomarkers.
FROM ACADEMIC EMERGENCY MEDICINE
Key clinical point: GFAP appears to be associated with severity of injury and identification of lesions on head CT scan after head trauma in youth.
Major finding: The negative predictive value was 98%, the specificity was 47%, and the sensitivity was 94% for detecting intracranial lesions when a GFAP cutoff level of 0.15 ng/mL was used.
Data source: A prospective controlled cohort study of children and youth who presented with a Glasgow Coma Scale score of 9-15 after blunt head trauma.
Disclosures: This study was supported by an award from the National Institute of Neurological Disorders and Stroke. Dr. Papa reported consulting for Banyan Biomarkers.
Study eyes liability associated with implantable devices for chronic pain
SAN DIEGO – The maintenance of implantable drug delivery systems for the management of chronic pain was associated with death, permanent brain damage, or permanent neurological injury from granuloma, and was largely associated with substandard care.
Those are key findings from an analysis of data from the Anesthesia Closed Claims Project that were presented by Dr. Dermot R. Fitzgibbon at the annual meeting of the American Society of Anesthesiologists.
“Implantable devices are relatively new in chronic pain management, and have only been available since the early 1990s,” said Dr. Fitzgibbon, professor of anesthesiology and pain medicine at the University of Washington, Seattle. Such devices are considered advanced techniques for refractory chronic pain and include implantable drug delivery systems, spinal cord stimulators, and peripheral nerve stimulators. Previous studies have demonstrated that morbidity and mortality from implantable drug delivery systems (IDDS) and spinal cord stimulators typically occur during implantation or removal of devices or during device maintenance (Neuromodulation. 2012;15[5]:467-82 and Clin J Pain. 2007;23[2]:180-95). The purpose of the current study was to investigate liability associated with implantable devices used to manage chronic pain.
Dr. Fitzgibbon and his associates used the Anesthesia Closed Claims Project Database to identify 970 claims related to chronic pain that have occurred since 1990. A total of 148 of these claims were related to implantable devices, and the majority of them were for surgical procedures (107 [72%] vs. 41 [28%] for IDDS maintenance).
Of the 107 surgical device procedures, 50% were for an IDDS system, followed by spinal cord stimulator (40%), tunneled epidural (7%), and peripheral nerve stimulator (3%). Temporary minor injury occurred in 74% of the surgical device procedures, followed by permanent cord injury (16%), death/permanent brain damage (8%), and other permanent injury (2%). The most common reasons for permanent spinal cord injury were needle or catheter trauma to the cord (7 cases), epidural hematoma (3 cases), and incorrect placement of the stimulator (2 cases). Infections occurred in 25 of the surgical device procedures. Among these 25 claims, 3 resulted in death or severe permanent injury, 7 involved retained parts and sponges, and 5 were cases of epidural abscess – 4 of which were associated with a tunneled epidural catheter.
Of the 41 damaging events that occurred during IDDS maintenance, 44% were temporary minor injuries, while 32% involved death or permanent brain damage from medication administration errors and 24% involved permanent spinal cord injury, primarily from a delay in recognition of granuloma formation at the catheter tip.
The researchers found that maintenance of IDDS, compared with claims related to other surgical devices, were more commonly associated with a risk of death or permanent damage, less commonly resulted in temporary minor injury, were more likely to have care deemed as substandard, and were more commonly associated with payments (P = .001 for all comparisons). The median payment for all claims was $274,000.
The Anesthesia Closed Claims Project is funded by the Anesthesia Quality Institute. Dr. Fitzgibbon reported having no financial disclosures.
SAN DIEGO – The maintenance of implantable drug delivery systems for the management of chronic pain was associated with death, permanent brain damage, or permanent neurological injury from granuloma, and was largely associated with substandard care.
Those are key findings from an analysis of data from the Anesthesia Closed Claims Project that were presented by Dr. Dermot R. Fitzgibbon at the annual meeting of the American Society of Anesthesiologists.
“Implantable devices are relatively new in chronic pain management, and have only been available since the early 1990s,” said Dr. Fitzgibbon, professor of anesthesiology and pain medicine at the University of Washington, Seattle. Such devices are considered advanced techniques for refractory chronic pain and include implantable drug delivery systems, spinal cord stimulators, and peripheral nerve stimulators. Previous studies have demonstrated that morbidity and mortality from implantable drug delivery systems (IDDS) and spinal cord stimulators typically occur during implantation or removal of devices or during device maintenance (Neuromodulation. 2012;15[5]:467-82 and Clin J Pain. 2007;23[2]:180-95). The purpose of the current study was to investigate liability associated with implantable devices used to manage chronic pain.
Dr. Fitzgibbon and his associates used the Anesthesia Closed Claims Project Database to identify 970 claims related to chronic pain that have occurred since 1990. A total of 148 of these claims were related to implantable devices, and the majority of them were for surgical procedures (107 [72%] vs. 41 [28%] for IDDS maintenance).
Of the 107 surgical device procedures, 50% were for an IDDS system, followed by spinal cord stimulator (40%), tunneled epidural (7%), and peripheral nerve stimulator (3%). Temporary minor injury occurred in 74% of the surgical device procedures, followed by permanent cord injury (16%), death/permanent brain damage (8%), and other permanent injury (2%). The most common reasons for permanent spinal cord injury were needle or catheter trauma to the cord (7 cases), epidural hematoma (3 cases), and incorrect placement of the stimulator (2 cases). Infections occurred in 25 of the surgical device procedures. Among these 25 claims, 3 resulted in death or severe permanent injury, 7 involved retained parts and sponges, and 5 were cases of epidural abscess – 4 of which were associated with a tunneled epidural catheter.
Of the 41 damaging events that occurred during IDDS maintenance, 44% were temporary minor injuries, while 32% involved death or permanent brain damage from medication administration errors and 24% involved permanent spinal cord injury, primarily from a delay in recognition of granuloma formation at the catheter tip.
The researchers found that maintenance of IDDS, compared with claims related to other surgical devices, were more commonly associated with a risk of death or permanent damage, less commonly resulted in temporary minor injury, were more likely to have care deemed as substandard, and were more commonly associated with payments (P = .001 for all comparisons). The median payment for all claims was $274,000.
The Anesthesia Closed Claims Project is funded by the Anesthesia Quality Institute. Dr. Fitzgibbon reported having no financial disclosures.
SAN DIEGO – The maintenance of implantable drug delivery systems for the management of chronic pain was associated with death, permanent brain damage, or permanent neurological injury from granuloma, and was largely associated with substandard care.
Those are key findings from an analysis of data from the Anesthesia Closed Claims Project that were presented by Dr. Dermot R. Fitzgibbon at the annual meeting of the American Society of Anesthesiologists.
“Implantable devices are relatively new in chronic pain management, and have only been available since the early 1990s,” said Dr. Fitzgibbon, professor of anesthesiology and pain medicine at the University of Washington, Seattle. Such devices are considered advanced techniques for refractory chronic pain and include implantable drug delivery systems, spinal cord stimulators, and peripheral nerve stimulators. Previous studies have demonstrated that morbidity and mortality from implantable drug delivery systems (IDDS) and spinal cord stimulators typically occur during implantation or removal of devices or during device maintenance (Neuromodulation. 2012;15[5]:467-82 and Clin J Pain. 2007;23[2]:180-95). The purpose of the current study was to investigate liability associated with implantable devices used to manage chronic pain.
Dr. Fitzgibbon and his associates used the Anesthesia Closed Claims Project Database to identify 970 claims related to chronic pain that have occurred since 1990. A total of 148 of these claims were related to implantable devices, and the majority of them were for surgical procedures (107 [72%] vs. 41 [28%] for IDDS maintenance).
Of the 107 surgical device procedures, 50% were for an IDDS system, followed by spinal cord stimulator (40%), tunneled epidural (7%), and peripheral nerve stimulator (3%). Temporary minor injury occurred in 74% of the surgical device procedures, followed by permanent cord injury (16%), death/permanent brain damage (8%), and other permanent injury (2%). The most common reasons for permanent spinal cord injury were needle or catheter trauma to the cord (7 cases), epidural hematoma (3 cases), and incorrect placement of the stimulator (2 cases). Infections occurred in 25 of the surgical device procedures. Among these 25 claims, 3 resulted in death or severe permanent injury, 7 involved retained parts and sponges, and 5 were cases of epidural abscess – 4 of which were associated with a tunneled epidural catheter.
Of the 41 damaging events that occurred during IDDS maintenance, 44% were temporary minor injuries, while 32% involved death or permanent brain damage from medication administration errors and 24% involved permanent spinal cord injury, primarily from a delay in recognition of granuloma formation at the catheter tip.
The researchers found that maintenance of IDDS, compared with claims related to other surgical devices, were more commonly associated with a risk of death or permanent damage, less commonly resulted in temporary minor injury, were more likely to have care deemed as substandard, and were more commonly associated with payments (P = .001 for all comparisons). The median payment for all claims was $274,000.
The Anesthesia Closed Claims Project is funded by the Anesthesia Quality Institute. Dr. Fitzgibbon reported having no financial disclosures.
AT THE ASA ANNUAL MEETING
Key clinical point: Malpractice claims for implantable devices for chronic pain are most often associated with maintenance of implantable drug delivery systems (IDDS) rather than the surgical placement of the devices.
Major finding: Maintenance of IDDS, compared with claims related to other surgical devices, was more commonly associated with a risk of death or permanent damage, less commonly resulted in temporary minor injury, was more likely to have care deemed as substandard, and was more commonly associated with payments (P = .001 for all comparisons).
Data source: An analysis of 970 claims related to chronic pain that have occurred since 1990.
Disclosures: The Anesthesia Closed Claims Project is funded by the Anesthesia Quality Institute. The researchers reported having no financial disclosures.
Concussionlike symptoms prevalent in uninjured teen athletes
Ensuring a high school athlete has returned to an asymptomatic state after a concussion can be challenging, according to the authors of a study that found a significant proportion of uninjured adolescent athletes report at least one symptom of concussion.
A cross-sectional observational study of 31,958 high school athletes, none of whom had experienced a concussion in the prior 6 months, showed 19% of boys and 28% of girls reported a symptom burden resembling an ICD-10 diagnosis of mild postconcussional syndrome, according to a paper published online Oct. 12 in JAMA Pediatrics.
Concussion symptoms were particularly prevalent among students with preexisting conditions such as psychiatric problems, learning disorders, migraine, attention deficit/hyperactivity disorder, or substance abuse. Students who had experienced a concussion previously were the least likely to show concussion symptoms (JAMA Pediatrics. 2015 Oct. 12 [doi: 10.1001/jamapediatrics.2015.2374]).
Boys most commonly reported symptoms such as fatigue, sleep troubles, and difficult concentration, while girls were more likely to report fatigue, sleep troubles, headaches, sadness, feeling emotional, and difficulty concentrating.
“When managing a student athlete with a concussion, it has been widely noted that the athlete should be ‘asymptomatic’ at rest and with exercise before returning to sports, and sometimes athletes are kept out of school for prolonged periods while they wait for symptoms to resolve, which could have negative consequences for their academic, social, and emotional functioning and contribute to symptom reporting,” wrote Grant L. Iverson, Ph.D., from Harvard Medical School, Boston, and his coauthors.
“These results reinforce that ‘asymptomatic’ status after concussion can be difficult to define,” they added.
The study was supported by the Goldfarb Center for Public Policy and Civic Engagement/Colby College, the Bill and Joan Alfond Foundation, the Harvard Integrated Program to Protect and Improve the Health of National Football League Players Association Members, and the Mooney-Reed Charitable Foundation. The lead author declared speakers fees from private industry, but there were no other conflicts of interest declared.
Ensuring a high school athlete has returned to an asymptomatic state after a concussion can be challenging, according to the authors of a study that found a significant proportion of uninjured adolescent athletes report at least one symptom of concussion.
A cross-sectional observational study of 31,958 high school athletes, none of whom had experienced a concussion in the prior 6 months, showed 19% of boys and 28% of girls reported a symptom burden resembling an ICD-10 diagnosis of mild postconcussional syndrome, according to a paper published online Oct. 12 in JAMA Pediatrics.
Concussion symptoms were particularly prevalent among students with preexisting conditions such as psychiatric problems, learning disorders, migraine, attention deficit/hyperactivity disorder, or substance abuse. Students who had experienced a concussion previously were the least likely to show concussion symptoms (JAMA Pediatrics. 2015 Oct. 12 [doi: 10.1001/jamapediatrics.2015.2374]).
Boys most commonly reported symptoms such as fatigue, sleep troubles, and difficult concentration, while girls were more likely to report fatigue, sleep troubles, headaches, sadness, feeling emotional, and difficulty concentrating.
“When managing a student athlete with a concussion, it has been widely noted that the athlete should be ‘asymptomatic’ at rest and with exercise before returning to sports, and sometimes athletes are kept out of school for prolonged periods while they wait for symptoms to resolve, which could have negative consequences for their academic, social, and emotional functioning and contribute to symptom reporting,” wrote Grant L. Iverson, Ph.D., from Harvard Medical School, Boston, and his coauthors.
“These results reinforce that ‘asymptomatic’ status after concussion can be difficult to define,” they added.
The study was supported by the Goldfarb Center for Public Policy and Civic Engagement/Colby College, the Bill and Joan Alfond Foundation, the Harvard Integrated Program to Protect and Improve the Health of National Football League Players Association Members, and the Mooney-Reed Charitable Foundation. The lead author declared speakers fees from private industry, but there were no other conflicts of interest declared.
Ensuring a high school athlete has returned to an asymptomatic state after a concussion can be challenging, according to the authors of a study that found a significant proportion of uninjured adolescent athletes report at least one symptom of concussion.
A cross-sectional observational study of 31,958 high school athletes, none of whom had experienced a concussion in the prior 6 months, showed 19% of boys and 28% of girls reported a symptom burden resembling an ICD-10 diagnosis of mild postconcussional syndrome, according to a paper published online Oct. 12 in JAMA Pediatrics.
Concussion symptoms were particularly prevalent among students with preexisting conditions such as psychiatric problems, learning disorders, migraine, attention deficit/hyperactivity disorder, or substance abuse. Students who had experienced a concussion previously were the least likely to show concussion symptoms (JAMA Pediatrics. 2015 Oct. 12 [doi: 10.1001/jamapediatrics.2015.2374]).
Boys most commonly reported symptoms such as fatigue, sleep troubles, and difficult concentration, while girls were more likely to report fatigue, sleep troubles, headaches, sadness, feeling emotional, and difficulty concentrating.
“When managing a student athlete with a concussion, it has been widely noted that the athlete should be ‘asymptomatic’ at rest and with exercise before returning to sports, and sometimes athletes are kept out of school for prolonged periods while they wait for symptoms to resolve, which could have negative consequences for their academic, social, and emotional functioning and contribute to symptom reporting,” wrote Grant L. Iverson, Ph.D., from Harvard Medical School, Boston, and his coauthors.
“These results reinforce that ‘asymptomatic’ status after concussion can be difficult to define,” they added.
The study was supported by the Goldfarb Center for Public Policy and Civic Engagement/Colby College, the Bill and Joan Alfond Foundation, the Harvard Integrated Program to Protect and Improve the Health of National Football League Players Association Members, and the Mooney-Reed Charitable Foundation. The lead author declared speakers fees from private industry, but there were no other conflicts of interest declared.
FROM JAMA PEDIATRICS
Key clinical point: A significant proportion of uninjured high school athletes reported at least one symptom of concussion.
Major finding: About one in five male high school athletes and one in four female high school athletes reported a symptom burden resembling an ICD-10 diagnosis of mild postconcussional syndrome.
Data source: A cross-sectional observational study of 31,958 high school athletes who had not experienced a concussion in the previous 6 months.
Disclosures: The study was supported by the Goldfarb Center for Public Policy and Civic Engagement/Colby College, the Bill and Joan Alfond Foundation, the Harvard Integrated Program to Protect and Improve the Health of National Football League Players Association Members, and the Mooney-Reed Charitable Foundation. The lead author declared speakers fees from private industry, but there were no other conflicts of interest declared.