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SAN DIEGO – Neurologists have long suspected that some stroke patients could benefit from thrombectomy many hours after they were last seen well. But lingering doubts remained, and physicians weren’t sure which stroke patients were likely to improve.

Now, with the early stoppage of two key clinical trials, the answer is clear, Jeffrey Saver, MD, director of the stroke unit at the University of California, Los Angeles, said in a video interview at the annual meeting of the American Neurological Association.

At the European Stroke Organization Conference in May, Stryker Neurovascular announced the results of its DAWN trial, which tested the company’s mechanical thrombectomy device in patients who’d suffered a stroke within the past 6-24 hours and in whom imaging showed a clinical core mismatch. It was stopped early based on an interim analysis after it met multiple prespecified stopping criteria. At 90 days, 48.6% of patients in the treatment group were functionally independent, compared with 13.1% who received only medical management.

The DEFUSE 3 trial examined endovascular thrombectomy in patients 6-16 hours after a stroke who appeared to have salvageable brain tissue based on target mismatch profile with a less extreme core than in DAWN. It too was halted early because of a high probability of efficacy. Together, the trials suggest neurologists are entering a new era of treating based on tissue and not just time, Dr. Saver said.

SAN DIEGO – Neurologists have long suspected that some stroke patients could benefit from thrombectomy many hours after they were last seen well. But lingering doubts remained, and physicians weren’t sure which stroke patients were likely to improve.

Now, with the early stoppage of two key clinical trials, the answer is clear, Jeffrey Saver, MD, director of the stroke unit at the University of California, Los Angeles, said in a video interview at the annual meeting of the American Neurological Association.

At the European Stroke Organization Conference in May, Stryker Neurovascular announced the results of its DAWN trial, which tested the company’s mechanical thrombectomy device in patients who’d suffered a stroke within the past 6-24 hours and in whom imaging showed a clinical core mismatch. It was stopped early based on an interim analysis after it met multiple prespecified stopping criteria. At 90 days, 48.6% of patients in the treatment group were functionally independent, compared with 13.1% who received only medical management.

The DEFUSE 3 trial examined endovascular thrombectomy in patients 6-16 hours after a stroke who appeared to have salvageable brain tissue based on target mismatch profile with a less extreme core than in DAWN. It too was halted early because of a high probability of efficacy. Together, the trials suggest neurologists are entering a new era of treating based on tissue and not just time, Dr. Saver said.

SAN DIEGO – Neurologists have long suspected that some stroke patients could benefit from thrombectomy many hours after they were last seen well. But lingering doubts remained, and physicians weren’t sure which stroke patients were likely to improve.

Now, with the early stoppage of two key clinical trials, the answer is clear, Jeffrey Saver, MD, director of the stroke unit at the University of California, Los Angeles, said in a video interview at the annual meeting of the American Neurological Association.

At the European Stroke Organization Conference in May, Stryker Neurovascular announced the results of its DAWN trial, which tested the company’s mechanical thrombectomy device in patients who’d suffered a stroke within the past 6-24 hours and in whom imaging showed a clinical core mismatch. It was stopped early based on an interim analysis after it met multiple prespecified stopping criteria. At 90 days, 48.6% of patients in the treatment group were functionally independent, compared with 13.1% who received only medical management.

The DEFUSE 3 trial examined endovascular thrombectomy in patients 6-16 hours after a stroke who appeared to have salvageable brain tissue based on target mismatch profile with a less extreme core than in DAWN. It too was halted early because of a high probability of efficacy. Together, the trials suggest neurologists are entering a new era of treating based on tissue and not just time, Dr. Saver said.

SAN DIEGO – It’s been possible for over 15 years for neurointensivists to measure the partial pressure of oxygen in the brain of patients following traumatic brain injury.

But the technology has not been widely adopted because there have been no high-quality data showing that it’s useful. As a result, in most hospitals, TBI treatment is guided mostly by intracranial pressure.

The evidence gap is being filled. In a recent phase 2 trial, there was a trend towards benefit when treatment was guided by both intracranial pressure and the brain oxygenation (Crit Care Med. 2017 Nov;45[11]:1907-14). The study was powered for nonfutility, not clinically meaningful change, but the National Institute of Neurological Disorders and Stroke has recently funded a 45-site, phase 3 trial that will definitively answer whether treatment protocols informed by both pressure and oxygen improve neurologic outcomes, said principal investigator Ramon Diaz-Arrastia, MD, PhD, a professor of neurology at the University of Pennsylvania, Philadelphia.

In an interview at the annual meeting of the American Neurological Association, he explained the work, and exactly how paying attention to brain oxygen levels changed treatment in the phase 2 study. It didn’t take anything unusual to maintain oxygen partial pressure above 20 mm Hg.

aotto@frontlinemedcom.com

SAN DIEGO – It’s been possible for over 15 years for neurointensivists to measure the partial pressure of oxygen in the brain of patients following traumatic brain injury.

But the technology has not been widely adopted because there have been no high-quality data showing that it’s useful. As a result, in most hospitals, TBI treatment is guided mostly by intracranial pressure.

The evidence gap is being filled. In a recent phase 2 trial, there was a trend towards benefit when treatment was guided by both intracranial pressure and the brain oxygenation (Crit Care Med. 2017 Nov;45[11]:1907-14). The study was powered for nonfutility, not clinically meaningful change, but the National Institute of Neurological Disorders and Stroke has recently funded a 45-site, phase 3 trial that will definitively answer whether treatment protocols informed by both pressure and oxygen improve neurologic outcomes, said principal investigator Ramon Diaz-Arrastia, MD, PhD, a professor of neurology at the University of Pennsylvania, Philadelphia.

In an interview at the annual meeting of the American Neurological Association, he explained the work, and exactly how paying attention to brain oxygen levels changed treatment in the phase 2 study. It didn’t take anything unusual to maintain oxygen partial pressure above 20 mm Hg.

aotto@frontlinemedcom.com

SAN DIEGO – It’s been possible for over 15 years for neurointensivists to measure the partial pressure of oxygen in the brain of patients following traumatic brain injury.

But the technology has not been widely adopted because there have been no high-quality data showing that it’s useful. As a result, in most hospitals, TBI treatment is guided mostly by intracranial pressure.

The evidence gap is being filled. In a recent phase 2 trial, there was a trend towards benefit when treatment was guided by both intracranial pressure and the brain oxygenation (Crit Care Med. 2017 Nov;45[11]:1907-14). The study was powered for nonfutility, not clinically meaningful change, but the National Institute of Neurological Disorders and Stroke has recently funded a 45-site, phase 3 trial that will definitively answer whether treatment protocols informed by both pressure and oxygen improve neurologic outcomes, said principal investigator Ramon Diaz-Arrastia, MD, PhD, a professor of neurology at the University of Pennsylvania, Philadelphia.

In an interview at the annual meeting of the American Neurological Association, he explained the work, and exactly how paying attention to brain oxygen levels changed treatment in the phase 2 study. It didn’t take anything unusual to maintain oxygen partial pressure above 20 mm Hg.

aotto@frontlinemedcom.com

SAN DIEGO – A blood test that could be on the market in as little as 2 years has an accuracy of 89% for detecting amyloid plaques in the brain, according to a report at the annual meeting of the American Neurological Association.

It measures the ratio of amyloid-beta 42 to amyloid-beta 40; the numbers refer to how many amino acids are in the proteins. In healthy individuals, the ratio is “remarkably consistent, but when beta-42 starts to stick to plaques in the brain, it doesn’t get out into the blood, and the ratio drops; that’s what we are detecting.” It’s highly accurate in both “Alzheimer’s patients and people who are completely normal who have amyloid plaques in their brains,” said Randall Bateman, MD, a professor of neurology at Washington University, St. Louis.

The test is being developed by C2N Diagnostics; Dr. Bateman is a cofounder and scientific adviser. The company is working with the Food and Drug Administration and the Centers for Medicare and Medicaid Services to commercialize the test.

If it makes it to market – which seems likely – it could be a game changer, not only for Alzheimer’s research, but also for screening, preclinical detection, and early treatment. At present, CNS amyloidosis is detected largely by positron emission tomography and radioactive tracers.

In an interview at the meeting, Dr. Bateman explained the test, the research behind it, and what it could mean for neurologists and patients. In short, “when effective drugs are found, the blood beta-amyloid test [could] be used to screen millions of people in the general public to identify who is at risk for Alzheimer’s disease” so they can “start treatments even before memory loss and brain damage begin,” he said.

Vidyard Video

 

aotto@frontlinemedcom.com

SAN DIEGO – A blood test that could be on the market in as little as 2 years has an accuracy of 89% for detecting amyloid plaques in the brain, according to a report at the annual meeting of the American Neurological Association.

It measures the ratio of amyloid-beta 42 to amyloid-beta 40; the numbers refer to how many amino acids are in the proteins. In healthy individuals, the ratio is “remarkably consistent, but when beta-42 starts to stick to plaques in the brain, it doesn’t get out into the blood, and the ratio drops; that’s what we are detecting.” It’s highly accurate in both “Alzheimer’s patients and people who are completely normal who have amyloid plaques in their brains,” said Randall Bateman, MD, a professor of neurology at Washington University, St. Louis.

The test is being developed by C2N Diagnostics; Dr. Bateman is a cofounder and scientific adviser. The company is working with the Food and Drug Administration and the Centers for Medicare and Medicaid Services to commercialize the test.

If it makes it to market – which seems likely – it could be a game changer, not only for Alzheimer’s research, but also for screening, preclinical detection, and early treatment. At present, CNS amyloidosis is detected largely by positron emission tomography and radioactive tracers.

In an interview at the meeting, Dr. Bateman explained the test, the research behind it, and what it could mean for neurologists and patients. In short, “when effective drugs are found, the blood beta-amyloid test [could] be used to screen millions of people in the general public to identify who is at risk for Alzheimer’s disease” so they can “start treatments even before memory loss and brain damage begin,” he said.

Vidyard Video

 

aotto@frontlinemedcom.com

SAN DIEGO – A blood test that could be on the market in as little as 2 years has an accuracy of 89% for detecting amyloid plaques in the brain, according to a report at the annual meeting of the American Neurological Association.

It measures the ratio of amyloid-beta 42 to amyloid-beta 40; the numbers refer to how many amino acids are in the proteins. In healthy individuals, the ratio is “remarkably consistent, but when beta-42 starts to stick to plaques in the brain, it doesn’t get out into the blood, and the ratio drops; that’s what we are detecting.” It’s highly accurate in both “Alzheimer’s patients and people who are completely normal who have amyloid plaques in their brains,” said Randall Bateman, MD, a professor of neurology at Washington University, St. Louis.

The test is being developed by C2N Diagnostics; Dr. Bateman is a cofounder and scientific adviser. The company is working with the Food and Drug Administration and the Centers for Medicare and Medicaid Services to commercialize the test.

If it makes it to market – which seems likely – it could be a game changer, not only for Alzheimer’s research, but also for screening, preclinical detection, and early treatment. At present, CNS amyloidosis is detected largely by positron emission tomography and radioactive tracers.

In an interview at the meeting, Dr. Bateman explained the test, the research behind it, and what it could mean for neurologists and patients. In short, “when effective drugs are found, the blood beta-amyloid test [could] be used to screen millions of people in the general public to identify who is at risk for Alzheimer’s disease” so they can “start treatments even before memory loss and brain damage begin,” he said.

Vidyard Video

 

aotto@frontlinemedcom.com

SAN DIEGO – The healthy brain is a master of autoregulation, continuously adjusting blood flow to meet metabolic demand.

But in traumatic brain injury, cerebrovascular reactivity (CVR) breaks down; blood vessels don’t dilate as they should to deliver nutrients and oxygen, leading to progressive neurologic decline.

Sildenafil (Viagra) – a vasodilator in injured blood vessels – might help, according to ongoing research at the University of Pennsylvania, Philadelphia.

Researchers there gave sildenafil to inpatients with persistent symptoms at least 6 months after traumatic brain injury and measured CVR by a novel MRI technique an hour later. “Sildenafil was able to correct the deficit in CVR in many cases. We are hopeful this could be a useful therapy,” said principal investigator Ramon Diaz-Arrastia, MD, a professor of neurology at the university.

He explained the work in an interview at annual meeting of the American Neurological Association. The next step is to see if sildenafil helps CVR in acute traumatic brain injury, and in people who have had multiple, mild brain traumas, including professional athletes.

aotto@frontlinemedcom.com

SAN DIEGO – The healthy brain is a master of autoregulation, continuously adjusting blood flow to meet metabolic demand.

But in traumatic brain injury, cerebrovascular reactivity (CVR) breaks down; blood vessels don’t dilate as they should to deliver nutrients and oxygen, leading to progressive neurologic decline.

Sildenafil (Viagra) – a vasodilator in injured blood vessels – might help, according to ongoing research at the University of Pennsylvania, Philadelphia.

Researchers there gave sildenafil to inpatients with persistent symptoms at least 6 months after traumatic brain injury and measured CVR by a novel MRI technique an hour later. “Sildenafil was able to correct the deficit in CVR in many cases. We are hopeful this could be a useful therapy,” said principal investigator Ramon Diaz-Arrastia, MD, a professor of neurology at the university.

He explained the work in an interview at annual meeting of the American Neurological Association. The next step is to see if sildenafil helps CVR in acute traumatic brain injury, and in people who have had multiple, mild brain traumas, including professional athletes.

aotto@frontlinemedcom.com

SAN DIEGO – The healthy brain is a master of autoregulation, continuously adjusting blood flow to meet metabolic demand.

But in traumatic brain injury, cerebrovascular reactivity (CVR) breaks down; blood vessels don’t dilate as they should to deliver nutrients and oxygen, leading to progressive neurologic decline.

Sildenafil (Viagra) – a vasodilator in injured blood vessels – might help, according to ongoing research at the University of Pennsylvania, Philadelphia.

Researchers there gave sildenafil to inpatients with persistent symptoms at least 6 months after traumatic brain injury and measured CVR by a novel MRI technique an hour later. “Sildenafil was able to correct the deficit in CVR in many cases. We are hopeful this could be a useful therapy,” said principal investigator Ramon Diaz-Arrastia, MD, a professor of neurology at the university.

He explained the work in an interview at annual meeting of the American Neurological Association. The next step is to see if sildenafil helps CVR in acute traumatic brain injury, and in people who have had multiple, mild brain traumas, including professional athletes.

aotto@frontlinemedcom.com

ORLANDO – A large percentage of U.S. gastroenterologists said that they don’t routinely order genetic testing for Lynch syndrome for patients with early-onset colorectal cancer, often because the physicians believe that the test is too expensive, or because they are unfamiliar with interpreting or applying the results, according to survey replies from 442 gastroenterologists.

Another factor hindering broader screening for Lynch syndrome (also known as hereditary nonpolyposis colorectal cancer) is that many of the surveyed gastroenterologists did not see themselves as having primary responsibility for ordering Lynch syndrome testing in patients who develop colorectal cancer before reaching age 50 years, Jordan J. Karlitz, MD, and his associates reported in a poster at the World Congress of Gastroenterology at ACG 2017.

The survey results showed that only a third of the survey respondents believed it primarily was the attending gastroenterologist’s responsibility to order testing for Lynch syndrome using either a microsatellite DNA instability test or by immunohistochemistry. A larger percentage, 38%, said that ordering one of these tests was something that a pathologist should arrange, 15% said it was primarily the responsibility of the attending medical oncologist, and the remaining respondents cited a surgeon or genetic counselor as having primary responsibility for ordering the test.

This absence of a clear consensus on who orders the test shows a “diffusion of responsibility” that often means testing is never ordered, Dr. Karlitz said in a video interview. What’s needed instead is “reflex testing” that’s done automatically for appropriate patients, an approach that has become standard at several U.S. medical centers, he noted.

The survey Dr. Karlitz and his associates ran stemmed from a report they published in 2015 that focused on management of the 274 patients diagnosed with early-onset colorectal cancer in Louisiana during 2011, defined as cancers diagnosed in patients aged 50 years or younger. Data collected in the Louisiana Tumor Registry showed that Lynch syndrome testing occurred for only 23% of these patients, the researchers reported (Am J Gastroenterol. 2015 Jul;110[7]:948-55).

To better understand the underpinnings of this low testing rate they sent a survey about Lynch syndrome testing by email in March 2017 to nearly 12,000 physicians on the membership roster of the American College of Gastroenterology. They received 455 replies, with 442 (97%) of the responses from gastroenterologists. When asked why they might not order Lynch syndrome testing for patients with early-onset colorectal cancer, 22% said the cost of testing was prohibitive, 18% blamed their lack of familiarity with the Lynch syndrome tests and how to properly interpret their results, and 15% attributed their decision to a lack of easy access to genetic counseling for their patients, with additional reasons cited by fewer respondents.

Dr. Karlitz noted that current recommendations from the National Comprehensive Cancer Network call for Lynch syndrome testing for all patients who develop colorectal cancer regardless of their age at diagnosis.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

ORLANDO – A large percentage of U.S. gastroenterologists said that they don’t routinely order genetic testing for Lynch syndrome for patients with early-onset colorectal cancer, often because the physicians believe that the test is too expensive, or because they are unfamiliar with interpreting or applying the results, according to survey replies from 442 gastroenterologists.

Another factor hindering broader screening for Lynch syndrome (also known as hereditary nonpolyposis colorectal cancer) is that many of the surveyed gastroenterologists did not see themselves as having primary responsibility for ordering Lynch syndrome testing in patients who develop colorectal cancer before reaching age 50 years, Jordan J. Karlitz, MD, and his associates reported in a poster at the World Congress of Gastroenterology at ACG 2017.

The survey results showed that only a third of the survey respondents believed it primarily was the attending gastroenterologist’s responsibility to order testing for Lynch syndrome using either a microsatellite DNA instability test or by immunohistochemistry. A larger percentage, 38%, said that ordering one of these tests was something that a pathologist should arrange, 15% said it was primarily the responsibility of the attending medical oncologist, and the remaining respondents cited a surgeon or genetic counselor as having primary responsibility for ordering the test.

This absence of a clear consensus on who orders the test shows a “diffusion of responsibility” that often means testing is never ordered, Dr. Karlitz said in a video interview. What’s needed instead is “reflex testing” that’s done automatically for appropriate patients, an approach that has become standard at several U.S. medical centers, he noted.

The survey Dr. Karlitz and his associates ran stemmed from a report they published in 2015 that focused on management of the 274 patients diagnosed with early-onset colorectal cancer in Louisiana during 2011, defined as cancers diagnosed in patients aged 50 years or younger. Data collected in the Louisiana Tumor Registry showed that Lynch syndrome testing occurred for only 23% of these patients, the researchers reported (Am J Gastroenterol. 2015 Jul;110[7]:948-55).

To better understand the underpinnings of this low testing rate they sent a survey about Lynch syndrome testing by email in March 2017 to nearly 12,000 physicians on the membership roster of the American College of Gastroenterology. They received 455 replies, with 442 (97%) of the responses from gastroenterologists. When asked why they might not order Lynch syndrome testing for patients with early-onset colorectal cancer, 22% said the cost of testing was prohibitive, 18% blamed their lack of familiarity with the Lynch syndrome tests and how to properly interpret their results, and 15% attributed their decision to a lack of easy access to genetic counseling for their patients, with additional reasons cited by fewer respondents.

Dr. Karlitz noted that current recommendations from the National Comprehensive Cancer Network call for Lynch syndrome testing for all patients who develop colorectal cancer regardless of their age at diagnosis.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

ORLANDO – A large percentage of U.S. gastroenterologists said that they don’t routinely order genetic testing for Lynch syndrome for patients with early-onset colorectal cancer, often because the physicians believe that the test is too expensive, or because they are unfamiliar with interpreting or applying the results, according to survey replies from 442 gastroenterologists.

Another factor hindering broader screening for Lynch syndrome (also known as hereditary nonpolyposis colorectal cancer) is that many of the surveyed gastroenterologists did not see themselves as having primary responsibility for ordering Lynch syndrome testing in patients who develop colorectal cancer before reaching age 50 years, Jordan J. Karlitz, MD, and his associates reported in a poster at the World Congress of Gastroenterology at ACG 2017.

The survey results showed that only a third of the survey respondents believed it primarily was the attending gastroenterologist’s responsibility to order testing for Lynch syndrome using either a microsatellite DNA instability test or by immunohistochemistry. A larger percentage, 38%, said that ordering one of these tests was something that a pathologist should arrange, 15% said it was primarily the responsibility of the attending medical oncologist, and the remaining respondents cited a surgeon or genetic counselor as having primary responsibility for ordering the test.

This absence of a clear consensus on who orders the test shows a “diffusion of responsibility” that often means testing is never ordered, Dr. Karlitz said in a video interview. What’s needed instead is “reflex testing” that’s done automatically for appropriate patients, an approach that has become standard at several U.S. medical centers, he noted.

The survey Dr. Karlitz and his associates ran stemmed from a report they published in 2015 that focused on management of the 274 patients diagnosed with early-onset colorectal cancer in Louisiana during 2011, defined as cancers diagnosed in patients aged 50 years or younger. Data collected in the Louisiana Tumor Registry showed that Lynch syndrome testing occurred for only 23% of these patients, the researchers reported (Am J Gastroenterol. 2015 Jul;110[7]:948-55).

To better understand the underpinnings of this low testing rate they sent a survey about Lynch syndrome testing by email in March 2017 to nearly 12,000 physicians on the membership roster of the American College of Gastroenterology. They received 455 replies, with 442 (97%) of the responses from gastroenterologists. When asked why they might not order Lynch syndrome testing for patients with early-onset colorectal cancer, 22% said the cost of testing was prohibitive, 18% blamed their lack of familiarity with the Lynch syndrome tests and how to properly interpret their results, and 15% attributed their decision to a lack of easy access to genetic counseling for their patients, with additional reasons cited by fewer respondents.

Dr. Karlitz noted that current recommendations from the National Comprehensive Cancer Network call for Lynch syndrome testing for all patients who develop colorectal cancer regardless of their age at diagnosis.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

SAN DIEGO – Mobile stroke units are specially equipped ambulance units designed to respond and deliver treatment to stroke patients as swiftly as possible. They are outfitted with a portable CT scanner, a mobile lab, and specialized personnel, including a telemedicine unit to assist with diagnosis. If a patient is experiencing an ischemic stroke, the unit can deliver thrombolytic therapy on the spot, circumventing travel to an emergency department.

But are they cost effective? There are 13 active units in the United States, and they’re not cheap. They cost about $3.5 million to build and operate over 5 years, according to James Grotta, MD, a neurologist with the Memorial Hermann Medical Group and director of stroke research at Memorial Hermann–Texas Medical Center, both in Houston.

In a video interview at the annual meeting of the American Neurological Association, Dr. Grotta described how his group is studying the impact of mobile stroke units on time to treatment and the long-term costs and cost savings associated with them in an ongoing clinical trial that is comparing outcomes in patients eligible for tissue plasminogen activator when treated by a mobile stroke unit versus standard prehospital triage and transport by emergency medical services. The study is comparing outcomes when the mobile stroke unit and emergency medical services are the primary responders on alternating weeks. Primary outcomes include cost-effectiveness, the change in Rankin scale score from baseline to 90 days, and the diagnostic agreement between a vascular neurologist in the mobile stroke unit and a telemedicine vascular neurologist consulted from the unit.

Mobile stroke units can even supplement existing health care in case of an emergency. Dr. Grotta also recounted how one unit assisted during the aftermath of Hurricane Harvey.

SAN DIEGO – Mobile stroke units are specially equipped ambulance units designed to respond and deliver treatment to stroke patients as swiftly as possible. They are outfitted with a portable CT scanner, a mobile lab, and specialized personnel, including a telemedicine unit to assist with diagnosis. If a patient is experiencing an ischemic stroke, the unit can deliver thrombolytic therapy on the spot, circumventing travel to an emergency department.

But are they cost effective? There are 13 active units in the United States, and they’re not cheap. They cost about $3.5 million to build and operate over 5 years, according to James Grotta, MD, a neurologist with the Memorial Hermann Medical Group and director of stroke research at Memorial Hermann–Texas Medical Center, both in Houston.

In a video interview at the annual meeting of the American Neurological Association, Dr. Grotta described how his group is studying the impact of mobile stroke units on time to treatment and the long-term costs and cost savings associated with them in an ongoing clinical trial that is comparing outcomes in patients eligible for tissue plasminogen activator when treated by a mobile stroke unit versus standard prehospital triage and transport by emergency medical services. The study is comparing outcomes when the mobile stroke unit and emergency medical services are the primary responders on alternating weeks. Primary outcomes include cost-effectiveness, the change in Rankin scale score from baseline to 90 days, and the diagnostic agreement between a vascular neurologist in the mobile stroke unit and a telemedicine vascular neurologist consulted from the unit.

Mobile stroke units can even supplement existing health care in case of an emergency. Dr. Grotta also recounted how one unit assisted during the aftermath of Hurricane Harvey.

SAN DIEGO – Mobile stroke units are specially equipped ambulance units designed to respond and deliver treatment to stroke patients as swiftly as possible. They are outfitted with a portable CT scanner, a mobile lab, and specialized personnel, including a telemedicine unit to assist with diagnosis. If a patient is experiencing an ischemic stroke, the unit can deliver thrombolytic therapy on the spot, circumventing travel to an emergency department.

But are they cost effective? There are 13 active units in the United States, and they’re not cheap. They cost about $3.5 million to build and operate over 5 years, according to James Grotta, MD, a neurologist with the Memorial Hermann Medical Group and director of stroke research at Memorial Hermann–Texas Medical Center, both in Houston.

In a video interview at the annual meeting of the American Neurological Association, Dr. Grotta described how his group is studying the impact of mobile stroke units on time to treatment and the long-term costs and cost savings associated with them in an ongoing clinical trial that is comparing outcomes in patients eligible for tissue plasminogen activator when treated by a mobile stroke unit versus standard prehospital triage and transport by emergency medical services. The study is comparing outcomes when the mobile stroke unit and emergency medical services are the primary responders on alternating weeks. Primary outcomes include cost-effectiveness, the change in Rankin scale score from baseline to 90 days, and the diagnostic agreement between a vascular neurologist in the mobile stroke unit and a telemedicine vascular neurologist consulted from the unit.

Mobile stroke units can even supplement existing health care in case of an emergency. Dr. Grotta also recounted how one unit assisted during the aftermath of Hurricane Harvey.

ORLANDO – An endoscopic approach to treatment of acute necrotizing pancreatitis was substantially safer than was minimally invasive surgical treatment in a randomized study of 66 patients.

Performing drainage and necrosectomy endoscopically in 34 patients with necrotizing pancreatitis that was symptomatic, infected, or both resulted in a 12% rate of major adverse events over the 3 months following intervention compared with a 38% rate among 32 similar patients who underwent laparoscopic drainage followed by either internal debridement or video-assisted retroperitoneal debridement, Ji Young Bang, MD, said at the World Congress of Gastroenterology at ACG 2017.

This statistically significant reduction in the study’s primary endpoint was driven primarily by a major reduction in the incidence of pancreaticocutaneous fistula, which occurred in none of the endoscopy patients and in eight (25%) of the surgery patients, and a smaller reduction in enterocutaneous fistula, which occurred in none of the endoscopy patients and in four (13%) of the patients treated surgically, said Dr. Bang, a gastroenterologist at the Center for Interventional Endoscopy at Florida Hospital, Orlando.

Based on these results, the endoscopic approach “is the treatment of the future,” Dr. Bang said in a video interview. Although the randomized study had a modest number of patients, it was adequately powered to address the hypothesis that endoscopy caused fewer major adverse events than did minimally invasive surgery, and hence the findings should have “an important clinical impact” on the choice of endoscopy or a minimally invasive surgical approach. But Dr. Bang also stressed that a successful endoscopic approach as obtained in this study requires treatment at a center that can offer multidisciplinary expertise from gastrointestinal endoscopists, surgeons, and radiologists, as well as infectious disease physicians, to minimize infections.

Prior to this study, results from the Pancreatitis, Endoscopic Transgastric vs Primary Necrosectomy in Patients With Infected Necrosis (PENGUIN) study run in the Netherlands had also shown significantly fewer adverse events with endoscopic treatment compared with laparoscopic surgery in 20 randomized patients (JAMA. 2012 Mar 14;307[10]:1053-61).

The study reported by Dr. Bang, the Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) trial, enrolled patients with an average necrotic collection size of about 11 cm. The average age of the patients was 59 years. Nearly half of the patients had confirmed infected necrosis. More than 90% had American Society of Anesthesiologists class III or IV disease, and about half had systemic inflammatory response syndrome. All patients had disease that was amenable to both the endoscopic and minimally invasive surgical approaches.

The study’s primary endpoint included several other adverse events in addition to fistulas during 3-month follow-up: death, new-onset organ failure or multiple systemic dysfunction, visceral perforation, and intra-abdominal bleeding. The incidence of each of these outcomes was about the same in the two study arms.

The results also showed that endoscopy was significantly better than surgery for several other secondary outcomes, including new-onset systemic inflammatory response syndrome as well as the prevalence of this complication 3 days after intervention (21% compared with 66%), days in the ICU, average total procedure and hospitalization cost ($76,000 compared with $117,000), and physical quality of life 3 months after treatment. For all other measured outcomes the endoscopic approach and surgical approach produced similar outcomes, and no outcome measured showed that endoscopy was significantly inferior to surgery, Dr. Bang reported.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

ORLANDO – An endoscopic approach to treatment of acute necrotizing pancreatitis was substantially safer than was minimally invasive surgical treatment in a randomized study of 66 patients.

Performing drainage and necrosectomy endoscopically in 34 patients with necrotizing pancreatitis that was symptomatic, infected, or both resulted in a 12% rate of major adverse events over the 3 months following intervention compared with a 38% rate among 32 similar patients who underwent laparoscopic drainage followed by either internal debridement or video-assisted retroperitoneal debridement, Ji Young Bang, MD, said at the World Congress of Gastroenterology at ACG 2017.

This statistically significant reduction in the study’s primary endpoint was driven primarily by a major reduction in the incidence of pancreaticocutaneous fistula, which occurred in none of the endoscopy patients and in eight (25%) of the surgery patients, and a smaller reduction in enterocutaneous fistula, which occurred in none of the endoscopy patients and in four (13%) of the patients treated surgically, said Dr. Bang, a gastroenterologist at the Center for Interventional Endoscopy at Florida Hospital, Orlando.

Based on these results, the endoscopic approach “is the treatment of the future,” Dr. Bang said in a video interview. Although the randomized study had a modest number of patients, it was adequately powered to address the hypothesis that endoscopy caused fewer major adverse events than did minimally invasive surgery, and hence the findings should have “an important clinical impact” on the choice of endoscopy or a minimally invasive surgical approach. But Dr. Bang also stressed that a successful endoscopic approach as obtained in this study requires treatment at a center that can offer multidisciplinary expertise from gastrointestinal endoscopists, surgeons, and radiologists, as well as infectious disease physicians, to minimize infections.

Prior to this study, results from the Pancreatitis, Endoscopic Transgastric vs Primary Necrosectomy in Patients With Infected Necrosis (PENGUIN) study run in the Netherlands had also shown significantly fewer adverse events with endoscopic treatment compared with laparoscopic surgery in 20 randomized patients (JAMA. 2012 Mar 14;307[10]:1053-61).

The study reported by Dr. Bang, the Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) trial, enrolled patients with an average necrotic collection size of about 11 cm. The average age of the patients was 59 years. Nearly half of the patients had confirmed infected necrosis. More than 90% had American Society of Anesthesiologists class III or IV disease, and about half had systemic inflammatory response syndrome. All patients had disease that was amenable to both the endoscopic and minimally invasive surgical approaches.

The study’s primary endpoint included several other adverse events in addition to fistulas during 3-month follow-up: death, new-onset organ failure or multiple systemic dysfunction, visceral perforation, and intra-abdominal bleeding. The incidence of each of these outcomes was about the same in the two study arms.

The results also showed that endoscopy was significantly better than surgery for several other secondary outcomes, including new-onset systemic inflammatory response syndrome as well as the prevalence of this complication 3 days after intervention (21% compared with 66%), days in the ICU, average total procedure and hospitalization cost ($76,000 compared with $117,000), and physical quality of life 3 months after treatment. For all other measured outcomes the endoscopic approach and surgical approach produced similar outcomes, and no outcome measured showed that endoscopy was significantly inferior to surgery, Dr. Bang reported.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

ORLANDO – An endoscopic approach to treatment of acute necrotizing pancreatitis was substantially safer than was minimally invasive surgical treatment in a randomized study of 66 patients.

Performing drainage and necrosectomy endoscopically in 34 patients with necrotizing pancreatitis that was symptomatic, infected, or both resulted in a 12% rate of major adverse events over the 3 months following intervention compared with a 38% rate among 32 similar patients who underwent laparoscopic drainage followed by either internal debridement or video-assisted retroperitoneal debridement, Ji Young Bang, MD, said at the World Congress of Gastroenterology at ACG 2017.

This statistically significant reduction in the study’s primary endpoint was driven primarily by a major reduction in the incidence of pancreaticocutaneous fistula, which occurred in none of the endoscopy patients and in eight (25%) of the surgery patients, and a smaller reduction in enterocutaneous fistula, which occurred in none of the endoscopy patients and in four (13%) of the patients treated surgically, said Dr. Bang, a gastroenterologist at the Center for Interventional Endoscopy at Florida Hospital, Orlando.

Based on these results, the endoscopic approach “is the treatment of the future,” Dr. Bang said in a video interview. Although the randomized study had a modest number of patients, it was adequately powered to address the hypothesis that endoscopy caused fewer major adverse events than did minimally invasive surgery, and hence the findings should have “an important clinical impact” on the choice of endoscopy or a minimally invasive surgical approach. But Dr. Bang also stressed that a successful endoscopic approach as obtained in this study requires treatment at a center that can offer multidisciplinary expertise from gastrointestinal endoscopists, surgeons, and radiologists, as well as infectious disease physicians, to minimize infections.

Prior to this study, results from the Pancreatitis, Endoscopic Transgastric vs Primary Necrosectomy in Patients With Infected Necrosis (PENGUIN) study run in the Netherlands had also shown significantly fewer adverse events with endoscopic treatment compared with laparoscopic surgery in 20 randomized patients (JAMA. 2012 Mar 14;307[10]:1053-61).

The study reported by Dr. Bang, the Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) trial, enrolled patients with an average necrotic collection size of about 11 cm. The average age of the patients was 59 years. Nearly half of the patients had confirmed infected necrosis. More than 90% had American Society of Anesthesiologists class III or IV disease, and about half had systemic inflammatory response syndrome. All patients had disease that was amenable to both the endoscopic and minimally invasive surgical approaches.

The study’s primary endpoint included several other adverse events in addition to fistulas during 3-month follow-up: death, new-onset organ failure or multiple systemic dysfunction, visceral perforation, and intra-abdominal bleeding. The incidence of each of these outcomes was about the same in the two study arms.

The results also showed that endoscopy was significantly better than surgery for several other secondary outcomes, including new-onset systemic inflammatory response syndrome as well as the prevalence of this complication 3 days after intervention (21% compared with 66%), days in the ICU, average total procedure and hospitalization cost ($76,000 compared with $117,000), and physical quality of life 3 months after treatment. For all other measured outcomes the endoscopic approach and surgical approach produced similar outcomes, and no outcome measured showed that endoscopy was significantly inferior to surgery, Dr. Bang reported.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

PHILADELPHIA – Despite the slow start that flibanserin had since being approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal women in 2015, more drugs are in the pipeline to help women address low desire.

One drug – bremelanotide – has completed phase 3 trials and could be considered by the Food and Drug Administration as early as 2018, Sheryl A. Kingsberg, PhD, said during an interview at the annual meeting of the North American Menopause Society.

Bremelanotide is a first-in-class melanocortin receptor 4 agonist being developed for premenopausal women to use on an as-needed basis and is delivered using a single-dose, auto injector.

Another drug, prasterone, is also being studied to treat HSDD. The intravaginal DHEA treatment is already approved to treat dyspareunia due to vulvovaginal atrophy in menopause. The manufacturer is beginning phase 3 trials for HSDD in postmenopausal women, said Dr. Kingsberg, who is chief of the division of behavioral medicine at MacDonald Women’s Hospital/University Hospitals Cleveland Medical Center and the president of NAMS.

Additional drugs are in earlier stages of development for HSDD. While flibanserin hasn’t been a blockbuster drug, its approval by the FDA paved the way for additional drug development in this area, Dr. Kingsberg said.

Dr. Kingsberg reported consultant/advisory board work for Amag Pharmaceuticals, Duchesnay, Emotional Brain, EndoCeutics, Materna Medical, Palatin Technologies, Pfizer, Shionogi, TherapeuticsMD, Valeant Pharmaceuticals, and Viveve. She is on the speakers bureau for Valeant Pharmaceuticals and owns stock in Viveve.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

PHILADELPHIA – Despite the slow start that flibanserin had since being approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal women in 2015, more drugs are in the pipeline to help women address low desire.

One drug – bremelanotide – has completed phase 3 trials and could be considered by the Food and Drug Administration as early as 2018, Sheryl A. Kingsberg, PhD, said during an interview at the annual meeting of the North American Menopause Society.

Bremelanotide is a first-in-class melanocortin receptor 4 agonist being developed for premenopausal women to use on an as-needed basis and is delivered using a single-dose, auto injector.

Another drug, prasterone, is also being studied to treat HSDD. The intravaginal DHEA treatment is already approved to treat dyspareunia due to vulvovaginal atrophy in menopause. The manufacturer is beginning phase 3 trials for HSDD in postmenopausal women, said Dr. Kingsberg, who is chief of the division of behavioral medicine at MacDonald Women’s Hospital/University Hospitals Cleveland Medical Center and the president of NAMS.

Additional drugs are in earlier stages of development for HSDD. While flibanserin hasn’t been a blockbuster drug, its approval by the FDA paved the way for additional drug development in this area, Dr. Kingsberg said.

Dr. Kingsberg reported consultant/advisory board work for Amag Pharmaceuticals, Duchesnay, Emotional Brain, EndoCeutics, Materna Medical, Palatin Technologies, Pfizer, Shionogi, TherapeuticsMD, Valeant Pharmaceuticals, and Viveve. She is on the speakers bureau for Valeant Pharmaceuticals and owns stock in Viveve.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

PHILADELPHIA – Despite the slow start that flibanserin had since being approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal women in 2015, more drugs are in the pipeline to help women address low desire.

One drug – bremelanotide – has completed phase 3 trials and could be considered by the Food and Drug Administration as early as 2018, Sheryl A. Kingsberg, PhD, said during an interview at the annual meeting of the North American Menopause Society.

Bremelanotide is a first-in-class melanocortin receptor 4 agonist being developed for premenopausal women to use on an as-needed basis and is delivered using a single-dose, auto injector.

Another drug, prasterone, is also being studied to treat HSDD. The intravaginal DHEA treatment is already approved to treat dyspareunia due to vulvovaginal atrophy in menopause. The manufacturer is beginning phase 3 trials for HSDD in postmenopausal women, said Dr. Kingsberg, who is chief of the division of behavioral medicine at MacDonald Women’s Hospital/University Hospitals Cleveland Medical Center and the president of NAMS.

Additional drugs are in earlier stages of development for HSDD. While flibanserin hasn’t been a blockbuster drug, its approval by the FDA paved the way for additional drug development in this area, Dr. Kingsberg said.

Dr. Kingsberg reported consultant/advisory board work for Amag Pharmaceuticals, Duchesnay, Emotional Brain, EndoCeutics, Materna Medical, Palatin Technologies, Pfizer, Shionogi, TherapeuticsMD, Valeant Pharmaceuticals, and Viveve. She is on the speakers bureau for Valeant Pharmaceuticals and owns stock in Viveve.

mschneider@frontlinemedcom.com

On Twitter @maryellenny