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Stroke hospitals owe all patients rapid thrombolysis
The best way to minimize death and disability in most patients having an acute ischemic stroke is rapid thrombolysis by infusion of tissue plasminogen activator. Mechanical clot removal – thrombectomy – has recently been shown even better, but it’s applicable to just a fraction of these stroke patients, and even for them thrombolysis remains, for the time being, the recommended first step, with thrombectomy following soon after.
The good news is that more eligible U.S. stroke patients than ever before get this effective treatment. As I reported recently from the International Stroke Conference, as of mid-2016, 68% of U.S. acute ischemic stroke patients treated at about 2,000 of the largest and most focused U.S. stroke hospitals received thrombolytic treatment within 60 minutes of their hospital arrival. That’s up from 30% in late 2009. Hooray! The sad news is that many eligible stroke patients seen at these hospitals don’t get treated this way. Simple math puts that figure at 32%. In other words, last year, nearly a third of U.S. stroke patients who should have received quick thrombolysis didn’t, even though they were taken to the country’s top stroke hospitals.
How do I know that more universal rapid thrombolysis is possible? The 2016 numbers reported from the Get With the Guidelines (GWTG)–Stroke hospitals showed that roughly 2% of the 788 hospitals included in this analysis treated 90% or more of their eligible stroke patients with thrombolysis within an hour. That’s about 16 hospitals. Another 8%, upward of 60 hospitals, treated 80%-89% of their eligible stroke patients within this window. So a high level of thrombolysis treatment is possible. It just isn’t being done everywhere. About 20% of the hospitals in the program treated 40% or fewer of eligible patients they saw within the 60-minute window.
I have no idea why some hospitals do so well while others don’t, despite being in the GWTG-Stroke program that promotes excellence in stroke care delivery. In the most recent iteration of the GWTG–Stroke Target Stroke program, phase II, the organization promoted 11 steps for hospitals to take to optimize rapid delivery of thrombolysis. The obvious inference is that some hospitals are doing all 11 steps very well and consistently, and many others aren’t. Underperforming hospitals owe it to their patients to do a much better job; the top-performing hospitals show it’s possible.
I have heard a lot recently at meetings about how research has established that a range of medical treatments, if used diligently by patients as directed, will substantially improve and prolong their life. Patient compliance then becomes a big issue, and so now I’m hearing more about new approaches to improve compliance. But what about hospital compliance?
Treating acute ischemic stroke as well as possible is different from most disorders – it’s not about patient compliance. It’s about the ambulance that picks up the patient and the hospital where the patient gets taken. The success or failure of the acute treatment that the roughly 700,000 annual U.S. acute ischemic stroke patients receive lies entirely in the hands of the hospital staff. Fewer than 10% of U.S. stroke hospitals offer the vast majority of these patients the best care currently available. Many others don’t do as well, and a huge fraction remain woefully slow, even though everyone knows the pathway to doing better. Underperforming hospitals owe it to patients to up their game, and they need to start doing it now.
[email protected]
On Twitter @mitchelzoler
The best way to minimize death and disability in most patients having an acute ischemic stroke is rapid thrombolysis by infusion of tissue plasminogen activator. Mechanical clot removal – thrombectomy – has recently been shown even better, but it’s applicable to just a fraction of these stroke patients, and even for them thrombolysis remains, for the time being, the recommended first step, with thrombectomy following soon after.
The good news is that more eligible U.S. stroke patients than ever before get this effective treatment. As I reported recently from the International Stroke Conference, as of mid-2016, 68% of U.S. acute ischemic stroke patients treated at about 2,000 of the largest and most focused U.S. stroke hospitals received thrombolytic treatment within 60 minutes of their hospital arrival. That’s up from 30% in late 2009. Hooray! The sad news is that many eligible stroke patients seen at these hospitals don’t get treated this way. Simple math puts that figure at 32%. In other words, last year, nearly a third of U.S. stroke patients who should have received quick thrombolysis didn’t, even though they were taken to the country’s top stroke hospitals.
How do I know that more universal rapid thrombolysis is possible? The 2016 numbers reported from the Get With the Guidelines (GWTG)–Stroke hospitals showed that roughly 2% of the 788 hospitals included in this analysis treated 90% or more of their eligible stroke patients with thrombolysis within an hour. That’s about 16 hospitals. Another 8%, upward of 60 hospitals, treated 80%-89% of their eligible stroke patients within this window. So a high level of thrombolysis treatment is possible. It just isn’t being done everywhere. About 20% of the hospitals in the program treated 40% or fewer of eligible patients they saw within the 60-minute window.
I have no idea why some hospitals do so well while others don’t, despite being in the GWTG-Stroke program that promotes excellence in stroke care delivery. In the most recent iteration of the GWTG–Stroke Target Stroke program, phase II, the organization promoted 11 steps for hospitals to take to optimize rapid delivery of thrombolysis. The obvious inference is that some hospitals are doing all 11 steps very well and consistently, and many others aren’t. Underperforming hospitals owe it to their patients to do a much better job; the top-performing hospitals show it’s possible.
I have heard a lot recently at meetings about how research has established that a range of medical treatments, if used diligently by patients as directed, will substantially improve and prolong their life. Patient compliance then becomes a big issue, and so now I’m hearing more about new approaches to improve compliance. But what about hospital compliance?
Treating acute ischemic stroke as well as possible is different from most disorders – it’s not about patient compliance. It’s about the ambulance that picks up the patient and the hospital where the patient gets taken. The success or failure of the acute treatment that the roughly 700,000 annual U.S. acute ischemic stroke patients receive lies entirely in the hands of the hospital staff. Fewer than 10% of U.S. stroke hospitals offer the vast majority of these patients the best care currently available. Many others don’t do as well, and a huge fraction remain woefully slow, even though everyone knows the pathway to doing better. Underperforming hospitals owe it to patients to up their game, and they need to start doing it now.
[email protected]
On Twitter @mitchelzoler
The best way to minimize death and disability in most patients having an acute ischemic stroke is rapid thrombolysis by infusion of tissue plasminogen activator. Mechanical clot removal – thrombectomy – has recently been shown even better, but it’s applicable to just a fraction of these stroke patients, and even for them thrombolysis remains, for the time being, the recommended first step, with thrombectomy following soon after.
The good news is that more eligible U.S. stroke patients than ever before get this effective treatment. As I reported recently from the International Stroke Conference, as of mid-2016, 68% of U.S. acute ischemic stroke patients treated at about 2,000 of the largest and most focused U.S. stroke hospitals received thrombolytic treatment within 60 minutes of their hospital arrival. That’s up from 30% in late 2009. Hooray! The sad news is that many eligible stroke patients seen at these hospitals don’t get treated this way. Simple math puts that figure at 32%. In other words, last year, nearly a third of U.S. stroke patients who should have received quick thrombolysis didn’t, even though they were taken to the country’s top stroke hospitals.
How do I know that more universal rapid thrombolysis is possible? The 2016 numbers reported from the Get With the Guidelines (GWTG)–Stroke hospitals showed that roughly 2% of the 788 hospitals included in this analysis treated 90% or more of their eligible stroke patients with thrombolysis within an hour. That’s about 16 hospitals. Another 8%, upward of 60 hospitals, treated 80%-89% of their eligible stroke patients within this window. So a high level of thrombolysis treatment is possible. It just isn’t being done everywhere. About 20% of the hospitals in the program treated 40% or fewer of eligible patients they saw within the 60-minute window.
I have no idea why some hospitals do so well while others don’t, despite being in the GWTG-Stroke program that promotes excellence in stroke care delivery. In the most recent iteration of the GWTG–Stroke Target Stroke program, phase II, the organization promoted 11 steps for hospitals to take to optimize rapid delivery of thrombolysis. The obvious inference is that some hospitals are doing all 11 steps very well and consistently, and many others aren’t. Underperforming hospitals owe it to their patients to do a much better job; the top-performing hospitals show it’s possible.
I have heard a lot recently at meetings about how research has established that a range of medical treatments, if used diligently by patients as directed, will substantially improve and prolong their life. Patient compliance then becomes a big issue, and so now I’m hearing more about new approaches to improve compliance. But what about hospital compliance?
Treating acute ischemic stroke as well as possible is different from most disorders – it’s not about patient compliance. It’s about the ambulance that picks up the patient and the hospital where the patient gets taken. The success or failure of the acute treatment that the roughly 700,000 annual U.S. acute ischemic stroke patients receive lies entirely in the hands of the hospital staff. Fewer than 10% of U.S. stroke hospitals offer the vast majority of these patients the best care currently available. Many others don’t do as well, and a huge fraction remain woefully slow, even though everyone knows the pathway to doing better. Underperforming hospitals owe it to patients to up their game, and they need to start doing it now.
[email protected]
On Twitter @mitchelzoler
Get With the Guidelines propels stroke thrombolytic therapy
HOUSTON – Thrombolytic therapy for U.S. patients experiencing an acute ischemic stroke is no longer the poster child for proven, but neglected, therapies.
Long bemoaned since its introduction in the mid-1990s as an effective but woefully underused treatment, thrombolytic therapy with tissue plasminogen activator (tPA) has seen robust growth in U.S. practice recently, largely due to the promotion and quality-improvement efforts of a voluntary, non-profit program, Get With the Guidelines (GWTG)-Stroke.
“We’ve seen a dramatic increase in tPA treatment in eligible patients,” said Dr. Smith, a neurologist and medical director of the Cognitive Neurosciences Clinic at the University of Calgary (Alta.).
“This represents remarkable and clinically meaningful improvements in stroke care, overcoming substantial barriers using a systems of care approach,” Gregg C. Fonarow, MD, professor of medicine and cochief of clinical cardiology at the University of California, Los Angeles and one of the long-time leaders of GWTG-Stroke, said in an interview. “This represents one of the most transformative improvements and success stories ever observed in stroke care.”
“These data show dramatic changes in the GWTG-Stroke hospitals,” agreed Lee H. Schwamm, MD, professor of neurology at Harvard Medical School and chief of stroke services at Massachusetts General Hospital in Boston and another leader of the GWTG-Stroke program. However, “we still have work to do,” cautioned Dr. Schwamm, who notes that 68% remains significantly short of the ideal 100%. The positive is that several GWTG-Stroke participating hospitals have surged to a better than 90% rate of administering tPA to eligible patients within a 60-minute door-to-needle window.
What is GWTG-Stroke?
GWTG was launched in 2000 by the American Heart Association as a hospital-based–quality improvement initiative focused on U.S. management of acute MI. In 2003, acute stroke became another focus of the program and inspired added participation of the American Stroke Association.
“Improvements in tPA use in eligible patients were seen soon after the introduction of GWTG-Stroke in 2003, but there was minimal improvement in the percentage of patients with door-to-needle times within 60 minutes despite national guidelines,” recalled Dr. Fonarow. This slow rate of advance led him, Dr. Schwamm, and others to create a more activist program within GWTG-Stroke, Target Stroke, that not only provided resources and collected data from participating hospitals but also set acute-treatment goals that challenged participating hospitals to up their game. Target Stroke phase I asked them to try to achieve a tPA door-to-needle time within 60 minutes in at least 50% of eligible patients. By mid-2013, the program reached this goal with 53% of patients treated in the allotted time frame (JAMA. 2014 Apr 23;311[16]:1632-40).
These time-based goals lead directly to meaningful improvements in patient outcomes. “We know that, for every 15 minute reduction in tPA door-to-needle time, there is a 5% reduction of in-hospital mortality and a substantial increase in the percentage of patients who are discharged home instead of to a rehabilitation hospital or nursing home,” Dr. Schwamm said.
Dr. Smith highlighted the 11 best practices steps that Target Stroke promotes to GWTG-Stroke hospitals as their road map to achieving the performance goals. These include things such as notification of a hospital by emergency medical services that a patient showing signs of an acute ischemic stroke is on the way, transfer of the patient after hospital arrival directly to a CT or MRI scanner to get the imaging that can confirm tPA eligibility, rapid reading of the scan, premixing of the tPA, a team-based approach to acute stroke management, and quick feedback to the team regarding their performance on each stroke patient they treat.
Dr. Schwamm noted that he, Dr. Fonarow, and other program leaders are already planning a phase III for Target Stroke that will branch out to even more facets of acute stroke care, such as incorporation of goals for using endovascular thrombectomy in appropriate patients and for using telemedicine to quicken and broaden the availability of expert neurologic consults for identifying tPA- and thrombectomy-eligible patients.
Growing the program
The success of GWTG-Stroke in transforming U.S. acute stroke care has not only relied on setting aggressive performance goals but also on advancing by boosting the number of U.S. hospitals participating of more U.S. hospitals. During the Target Stroke years since the start of 2010, the number of hospitals active in GWTG-Stroke jumped from 1427 to 1,950 by mid-2016, including a 12% year-over-year jump in 2016, compared with 2015. During October 2015-October 2016, participating hospitals treated more than 570,000 acute stroke patients, or roughly 71% of the estimated 800,000 U.S. patients who have an acute stroke each year.
These numbers seem on track to continue expanding. “With the recent evidence showing that participating in GWTG-Stroke improves care and outcomes there has been even greater interest by hospitals, recently, in joining,” said Dr. Fonarow. “While many hospitals currently participate, ideally all would join and be active.”
“Hospitals now feel that they can’t afford not to focus on stroke as a quality improvement program, so they join,” said Dr. Schwamm. He believes that essentially all of the roughly 200 certified U.S. Comprehensive Stroke Centers and of the roughly 1,000 certified U.S. Primary Stroke Centers are already members of GWTG-Stroke. “We’re now in all the high-value hospitals, based on their higher numbers of patients. It’s the Acute Stroke Ready hospitals where we now have the greatest potential to penetrate, hospitals that generally treat about 20-50 stroke patients a year,” he said.
Joining GWTG-Stroke holds major attraction for hospitals because the program gives them a tool for measuring their performance, data that hospitals often now need to prove the value of the care they deliver to insurers and to avoid penalization for readmissions. However, the barrier to hospitals, especially smaller hospitals, is that data collection can be expensive. It’s something that larger hospitals now routinely do, but smaller hospitals have often balked because of the expense. To address this, the GWTG-Stroke program is trying to develop a “lighter” version of their data collection tool that involves a smaller financial burden.
“I think we can sell a trimmed down version of GWTG-Stroke to smaller hospitals that is affordable and use it to recruit another 1,000 hospitals. That’s a realistic goal,” Dr. Schwamm said.
What is also notable about GWTG-Stroke is that hospitals sign up despite the somewhat ambiguous payback they receive.
“In the past, stroke was the third-leading U.S. cause of death, but now it’s fifth,” noted Steven R. Messe, MD, a stroke neurologist at the University of Pennsylvania in Philadelphia and a member of the GWTG-Stroke steering committee. “That’s an amazing accomplishment – to drop stroke from third place to fifth – and it’s due to advances in thrombolytic use and to improved systems of care and quality improvement measures.”
Get With the Guidelines-Stroke is a program of the American Heart Association and American Stroke Association and uses funding provided by several drug companies. Dr. Smith, Dr. Fonarow, Dr. Schwamm and Dr. Messe had no relevant commercial disclosures.
[email protected]
On Twitter @mitchelzoler
HOUSTON – Thrombolytic therapy for U.S. patients experiencing an acute ischemic stroke is no longer the poster child for proven, but neglected, therapies.
Long bemoaned since its introduction in the mid-1990s as an effective but woefully underused treatment, thrombolytic therapy with tissue plasminogen activator (tPA) has seen robust growth in U.S. practice recently, largely due to the promotion and quality-improvement efforts of a voluntary, non-profit program, Get With the Guidelines (GWTG)-Stroke.
“We’ve seen a dramatic increase in tPA treatment in eligible patients,” said Dr. Smith, a neurologist and medical director of the Cognitive Neurosciences Clinic at the University of Calgary (Alta.).
“This represents remarkable and clinically meaningful improvements in stroke care, overcoming substantial barriers using a systems of care approach,” Gregg C. Fonarow, MD, professor of medicine and cochief of clinical cardiology at the University of California, Los Angeles and one of the long-time leaders of GWTG-Stroke, said in an interview. “This represents one of the most transformative improvements and success stories ever observed in stroke care.”
“These data show dramatic changes in the GWTG-Stroke hospitals,” agreed Lee H. Schwamm, MD, professor of neurology at Harvard Medical School and chief of stroke services at Massachusetts General Hospital in Boston and another leader of the GWTG-Stroke program. However, “we still have work to do,” cautioned Dr. Schwamm, who notes that 68% remains significantly short of the ideal 100%. The positive is that several GWTG-Stroke participating hospitals have surged to a better than 90% rate of administering tPA to eligible patients within a 60-minute door-to-needle window.
What is GWTG-Stroke?
GWTG was launched in 2000 by the American Heart Association as a hospital-based–quality improvement initiative focused on U.S. management of acute MI. In 2003, acute stroke became another focus of the program and inspired added participation of the American Stroke Association.
“Improvements in tPA use in eligible patients were seen soon after the introduction of GWTG-Stroke in 2003, but there was minimal improvement in the percentage of patients with door-to-needle times within 60 minutes despite national guidelines,” recalled Dr. Fonarow. This slow rate of advance led him, Dr. Schwamm, and others to create a more activist program within GWTG-Stroke, Target Stroke, that not only provided resources and collected data from participating hospitals but also set acute-treatment goals that challenged participating hospitals to up their game. Target Stroke phase I asked them to try to achieve a tPA door-to-needle time within 60 minutes in at least 50% of eligible patients. By mid-2013, the program reached this goal with 53% of patients treated in the allotted time frame (JAMA. 2014 Apr 23;311[16]:1632-40).
These time-based goals lead directly to meaningful improvements in patient outcomes. “We know that, for every 15 minute reduction in tPA door-to-needle time, there is a 5% reduction of in-hospital mortality and a substantial increase in the percentage of patients who are discharged home instead of to a rehabilitation hospital or nursing home,” Dr. Schwamm said.
Dr. Smith highlighted the 11 best practices steps that Target Stroke promotes to GWTG-Stroke hospitals as their road map to achieving the performance goals. These include things such as notification of a hospital by emergency medical services that a patient showing signs of an acute ischemic stroke is on the way, transfer of the patient after hospital arrival directly to a CT or MRI scanner to get the imaging that can confirm tPA eligibility, rapid reading of the scan, premixing of the tPA, a team-based approach to acute stroke management, and quick feedback to the team regarding their performance on each stroke patient they treat.
Dr. Schwamm noted that he, Dr. Fonarow, and other program leaders are already planning a phase III for Target Stroke that will branch out to even more facets of acute stroke care, such as incorporation of goals for using endovascular thrombectomy in appropriate patients and for using telemedicine to quicken and broaden the availability of expert neurologic consults for identifying tPA- and thrombectomy-eligible patients.
Growing the program
The success of GWTG-Stroke in transforming U.S. acute stroke care has not only relied on setting aggressive performance goals but also on advancing by boosting the number of U.S. hospitals participating of more U.S. hospitals. During the Target Stroke years since the start of 2010, the number of hospitals active in GWTG-Stroke jumped from 1427 to 1,950 by mid-2016, including a 12% year-over-year jump in 2016, compared with 2015. During October 2015-October 2016, participating hospitals treated more than 570,000 acute stroke patients, or roughly 71% of the estimated 800,000 U.S. patients who have an acute stroke each year.
These numbers seem on track to continue expanding. “With the recent evidence showing that participating in GWTG-Stroke improves care and outcomes there has been even greater interest by hospitals, recently, in joining,” said Dr. Fonarow. “While many hospitals currently participate, ideally all would join and be active.”
“Hospitals now feel that they can’t afford not to focus on stroke as a quality improvement program, so they join,” said Dr. Schwamm. He believes that essentially all of the roughly 200 certified U.S. Comprehensive Stroke Centers and of the roughly 1,000 certified U.S. Primary Stroke Centers are already members of GWTG-Stroke. “We’re now in all the high-value hospitals, based on their higher numbers of patients. It’s the Acute Stroke Ready hospitals where we now have the greatest potential to penetrate, hospitals that generally treat about 20-50 stroke patients a year,” he said.
Joining GWTG-Stroke holds major attraction for hospitals because the program gives them a tool for measuring their performance, data that hospitals often now need to prove the value of the care they deliver to insurers and to avoid penalization for readmissions. However, the barrier to hospitals, especially smaller hospitals, is that data collection can be expensive. It’s something that larger hospitals now routinely do, but smaller hospitals have often balked because of the expense. To address this, the GWTG-Stroke program is trying to develop a “lighter” version of their data collection tool that involves a smaller financial burden.
“I think we can sell a trimmed down version of GWTG-Stroke to smaller hospitals that is affordable and use it to recruit another 1,000 hospitals. That’s a realistic goal,” Dr. Schwamm said.
What is also notable about GWTG-Stroke is that hospitals sign up despite the somewhat ambiguous payback they receive.
“In the past, stroke was the third-leading U.S. cause of death, but now it’s fifth,” noted Steven R. Messe, MD, a stroke neurologist at the University of Pennsylvania in Philadelphia and a member of the GWTG-Stroke steering committee. “That’s an amazing accomplishment – to drop stroke from third place to fifth – and it’s due to advances in thrombolytic use and to improved systems of care and quality improvement measures.”
Get With the Guidelines-Stroke is a program of the American Heart Association and American Stroke Association and uses funding provided by several drug companies. Dr. Smith, Dr. Fonarow, Dr. Schwamm and Dr. Messe had no relevant commercial disclosures.
[email protected]
On Twitter @mitchelzoler
HOUSTON – Thrombolytic therapy for U.S. patients experiencing an acute ischemic stroke is no longer the poster child for proven, but neglected, therapies.
Long bemoaned since its introduction in the mid-1990s as an effective but woefully underused treatment, thrombolytic therapy with tissue plasminogen activator (tPA) has seen robust growth in U.S. practice recently, largely due to the promotion and quality-improvement efforts of a voluntary, non-profit program, Get With the Guidelines (GWTG)-Stroke.
“We’ve seen a dramatic increase in tPA treatment in eligible patients,” said Dr. Smith, a neurologist and medical director of the Cognitive Neurosciences Clinic at the University of Calgary (Alta.).
“This represents remarkable and clinically meaningful improvements in stroke care, overcoming substantial barriers using a systems of care approach,” Gregg C. Fonarow, MD, professor of medicine and cochief of clinical cardiology at the University of California, Los Angeles and one of the long-time leaders of GWTG-Stroke, said in an interview. “This represents one of the most transformative improvements and success stories ever observed in stroke care.”
“These data show dramatic changes in the GWTG-Stroke hospitals,” agreed Lee H. Schwamm, MD, professor of neurology at Harvard Medical School and chief of stroke services at Massachusetts General Hospital in Boston and another leader of the GWTG-Stroke program. However, “we still have work to do,” cautioned Dr. Schwamm, who notes that 68% remains significantly short of the ideal 100%. The positive is that several GWTG-Stroke participating hospitals have surged to a better than 90% rate of administering tPA to eligible patients within a 60-minute door-to-needle window.
What is GWTG-Stroke?
GWTG was launched in 2000 by the American Heart Association as a hospital-based–quality improvement initiative focused on U.S. management of acute MI. In 2003, acute stroke became another focus of the program and inspired added participation of the American Stroke Association.
“Improvements in tPA use in eligible patients were seen soon after the introduction of GWTG-Stroke in 2003, but there was minimal improvement in the percentage of patients with door-to-needle times within 60 minutes despite national guidelines,” recalled Dr. Fonarow. This slow rate of advance led him, Dr. Schwamm, and others to create a more activist program within GWTG-Stroke, Target Stroke, that not only provided resources and collected data from participating hospitals but also set acute-treatment goals that challenged participating hospitals to up their game. Target Stroke phase I asked them to try to achieve a tPA door-to-needle time within 60 minutes in at least 50% of eligible patients. By mid-2013, the program reached this goal with 53% of patients treated in the allotted time frame (JAMA. 2014 Apr 23;311[16]:1632-40).
These time-based goals lead directly to meaningful improvements in patient outcomes. “We know that, for every 15 minute reduction in tPA door-to-needle time, there is a 5% reduction of in-hospital mortality and a substantial increase in the percentage of patients who are discharged home instead of to a rehabilitation hospital or nursing home,” Dr. Schwamm said.
Dr. Smith highlighted the 11 best practices steps that Target Stroke promotes to GWTG-Stroke hospitals as their road map to achieving the performance goals. These include things such as notification of a hospital by emergency medical services that a patient showing signs of an acute ischemic stroke is on the way, transfer of the patient after hospital arrival directly to a CT or MRI scanner to get the imaging that can confirm tPA eligibility, rapid reading of the scan, premixing of the tPA, a team-based approach to acute stroke management, and quick feedback to the team regarding their performance on each stroke patient they treat.
Dr. Schwamm noted that he, Dr. Fonarow, and other program leaders are already planning a phase III for Target Stroke that will branch out to even more facets of acute stroke care, such as incorporation of goals for using endovascular thrombectomy in appropriate patients and for using telemedicine to quicken and broaden the availability of expert neurologic consults for identifying tPA- and thrombectomy-eligible patients.
Growing the program
The success of GWTG-Stroke in transforming U.S. acute stroke care has not only relied on setting aggressive performance goals but also on advancing by boosting the number of U.S. hospitals participating of more U.S. hospitals. During the Target Stroke years since the start of 2010, the number of hospitals active in GWTG-Stroke jumped from 1427 to 1,950 by mid-2016, including a 12% year-over-year jump in 2016, compared with 2015. During October 2015-October 2016, participating hospitals treated more than 570,000 acute stroke patients, or roughly 71% of the estimated 800,000 U.S. patients who have an acute stroke each year.
These numbers seem on track to continue expanding. “With the recent evidence showing that participating in GWTG-Stroke improves care and outcomes there has been even greater interest by hospitals, recently, in joining,” said Dr. Fonarow. “While many hospitals currently participate, ideally all would join and be active.”
“Hospitals now feel that they can’t afford not to focus on stroke as a quality improvement program, so they join,” said Dr. Schwamm. He believes that essentially all of the roughly 200 certified U.S. Comprehensive Stroke Centers and of the roughly 1,000 certified U.S. Primary Stroke Centers are already members of GWTG-Stroke. “We’re now in all the high-value hospitals, based on their higher numbers of patients. It’s the Acute Stroke Ready hospitals where we now have the greatest potential to penetrate, hospitals that generally treat about 20-50 stroke patients a year,” he said.
Joining GWTG-Stroke holds major attraction for hospitals because the program gives them a tool for measuring their performance, data that hospitals often now need to prove the value of the care they deliver to insurers and to avoid penalization for readmissions. However, the barrier to hospitals, especially smaller hospitals, is that data collection can be expensive. It’s something that larger hospitals now routinely do, but smaller hospitals have often balked because of the expense. To address this, the GWTG-Stroke program is trying to develop a “lighter” version of their data collection tool that involves a smaller financial burden.
“I think we can sell a trimmed down version of GWTG-Stroke to smaller hospitals that is affordable and use it to recruit another 1,000 hospitals. That’s a realistic goal,” Dr. Schwamm said.
What is also notable about GWTG-Stroke is that hospitals sign up despite the somewhat ambiguous payback they receive.
“In the past, stroke was the third-leading U.S. cause of death, but now it’s fifth,” noted Steven R. Messe, MD, a stroke neurologist at the University of Pennsylvania in Philadelphia and a member of the GWTG-Stroke steering committee. “That’s an amazing accomplishment – to drop stroke from third place to fifth – and it’s due to advances in thrombolytic use and to improved systems of care and quality improvement measures.”
Get With the Guidelines-Stroke is a program of the American Heart Association and American Stroke Association and uses funding provided by several drug companies. Dr. Smith, Dr. Fonarow, Dr. Schwamm and Dr. Messe had no relevant commercial disclosures.
[email protected]
On Twitter @mitchelzoler
EXPERT ANALYSIS FROM THE INTERNATIONAL STROKE CONFERENCE
BNP flags high atrial fibrillation prevalence in ESUS stroke
HOUSTON – Following an embolic stroke of undetermined source, a patient’s serum level of brain natriuretic peptide may identify patients at high risk of having covert atrial fibrillation that warrants assessment by prolonged arrhythmia monitoring, based on a post hoc analysis of data collected from 373 patients.
The analysis showed that in older patients with a recent embolic stroke of undetermined source (ESUS) who had a serum brain natriuretic peptide (BNP) level of 100 pg/mL or greater, the prevalence of atrial fibrillation (AF) detected by up to 30 days of Holter monitoring was 33%. In contrast the AF prevalence was 4% among similar ESUS patients with a lower BNP level, Rolf Wachter, MD, said at the International Stroke Conference sponsored by the American Heart Association.
“This evidence is pretty compelling,” commented Hooman Kamel, MD, a neurologist at Weill Cornell Medicine in New York. “We already use other lab tests that have less evidence supporting their use than this, and checking BNP is a simple lab test.”
The results showed that monitoring identified AF in 5% of the control patients and in 14% of those who underwent extended monitoring, a statistically significant difference (Lancet Neurol. 2017 Apr;16[4]:282-90).
Dr. Wachter and his colleagues had baseline BNP measurements for 373 of the patients and analyzed the prevalence of AF based on these levels. The patients averaged 72 years old. Among those with BNP values of at least 100 pg/mL, prolonged arrhythmia monitoring found AF in 33%, while briefer, conventional monitoring found AF in about 4%. This meant that for every three patients receiving prolonged arrhythmia scrutiny in this subgroup, the assessment found one patient with AF. But among patients with a serum BNP of less than 100 pg/mL, prolonged arrhythmia assessment yielded a 10% rate of AF detection, compared with about 4% in the controls, meaning that for every 18 patients screened prolonged Holter monitoring detected one additional case of AF, he reported.
This relationship presumably exists because higher BNP levels identify patients with structural heart abnormalities, a subgroup at increased risk for AF, Dr. Wachter explained. He cautioned that, because this was a post hoc analysis, he would like to see the findings confirmed in prospective studies.
Dr. Wachter has been a speaker on behalf of Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and Daiichi Sankyo and has received research support from Boehringer Ingelheim. The FIND-AFRANDOMISED trial received funding from Boehringer Ingelheim.
[email protected]
On Twitter @mitchelzoler
HOUSTON – Following an embolic stroke of undetermined source, a patient’s serum level of brain natriuretic peptide may identify patients at high risk of having covert atrial fibrillation that warrants assessment by prolonged arrhythmia monitoring, based on a post hoc analysis of data collected from 373 patients.
The analysis showed that in older patients with a recent embolic stroke of undetermined source (ESUS) who had a serum brain natriuretic peptide (BNP) level of 100 pg/mL or greater, the prevalence of atrial fibrillation (AF) detected by up to 30 days of Holter monitoring was 33%. In contrast the AF prevalence was 4% among similar ESUS patients with a lower BNP level, Rolf Wachter, MD, said at the International Stroke Conference sponsored by the American Heart Association.
“This evidence is pretty compelling,” commented Hooman Kamel, MD, a neurologist at Weill Cornell Medicine in New York. “We already use other lab tests that have less evidence supporting their use than this, and checking BNP is a simple lab test.”
The results showed that monitoring identified AF in 5% of the control patients and in 14% of those who underwent extended monitoring, a statistically significant difference (Lancet Neurol. 2017 Apr;16[4]:282-90).
Dr. Wachter and his colleagues had baseline BNP measurements for 373 of the patients and analyzed the prevalence of AF based on these levels. The patients averaged 72 years old. Among those with BNP values of at least 100 pg/mL, prolonged arrhythmia monitoring found AF in 33%, while briefer, conventional monitoring found AF in about 4%. This meant that for every three patients receiving prolonged arrhythmia scrutiny in this subgroup, the assessment found one patient with AF. But among patients with a serum BNP of less than 100 pg/mL, prolonged arrhythmia assessment yielded a 10% rate of AF detection, compared with about 4% in the controls, meaning that for every 18 patients screened prolonged Holter monitoring detected one additional case of AF, he reported.
This relationship presumably exists because higher BNP levels identify patients with structural heart abnormalities, a subgroup at increased risk for AF, Dr. Wachter explained. He cautioned that, because this was a post hoc analysis, he would like to see the findings confirmed in prospective studies.
Dr. Wachter has been a speaker on behalf of Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and Daiichi Sankyo and has received research support from Boehringer Ingelheim. The FIND-AFRANDOMISED trial received funding from Boehringer Ingelheim.
[email protected]
On Twitter @mitchelzoler
HOUSTON – Following an embolic stroke of undetermined source, a patient’s serum level of brain natriuretic peptide may identify patients at high risk of having covert atrial fibrillation that warrants assessment by prolonged arrhythmia monitoring, based on a post hoc analysis of data collected from 373 patients.
The analysis showed that in older patients with a recent embolic stroke of undetermined source (ESUS) who had a serum brain natriuretic peptide (BNP) level of 100 pg/mL or greater, the prevalence of atrial fibrillation (AF) detected by up to 30 days of Holter monitoring was 33%. In contrast the AF prevalence was 4% among similar ESUS patients with a lower BNP level, Rolf Wachter, MD, said at the International Stroke Conference sponsored by the American Heart Association.
“This evidence is pretty compelling,” commented Hooman Kamel, MD, a neurologist at Weill Cornell Medicine in New York. “We already use other lab tests that have less evidence supporting their use than this, and checking BNP is a simple lab test.”
The results showed that monitoring identified AF in 5% of the control patients and in 14% of those who underwent extended monitoring, a statistically significant difference (Lancet Neurol. 2017 Apr;16[4]:282-90).
Dr. Wachter and his colleagues had baseline BNP measurements for 373 of the patients and analyzed the prevalence of AF based on these levels. The patients averaged 72 years old. Among those with BNP values of at least 100 pg/mL, prolonged arrhythmia monitoring found AF in 33%, while briefer, conventional monitoring found AF in about 4%. This meant that for every three patients receiving prolonged arrhythmia scrutiny in this subgroup, the assessment found one patient with AF. But among patients with a serum BNP of less than 100 pg/mL, prolonged arrhythmia assessment yielded a 10% rate of AF detection, compared with about 4% in the controls, meaning that for every 18 patients screened prolonged Holter monitoring detected one additional case of AF, he reported.
This relationship presumably exists because higher BNP levels identify patients with structural heart abnormalities, a subgroup at increased risk for AF, Dr. Wachter explained. He cautioned that, because this was a post hoc analysis, he would like to see the findings confirmed in prospective studies.
Dr. Wachter has been a speaker on behalf of Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and Daiichi Sankyo and has received research support from Boehringer Ingelheim. The FIND-AFRANDOMISED trial received funding from Boehringer Ingelheim.
[email protected]
On Twitter @mitchelzoler
AT THE INTERNATIONAL STROKE CONFERENCE
Key clinical point:
Major finding: Following ESUS, patients with a BNP of 100 pg/mL or greater had a 33% prevalence of AF.
Data source: A post hoc analysis of 373 German patients enrolled in the FIND-AFRANDOMISED trial.
Disclosures: Dr. Wachter has been a speaker on behalf of Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and Daiichi Sankyo and has received research support from Boehringer Ingelheim. The FIND-AFRANDOMISED trial received funding from Boehringer Ingelheim.
VIDEO: Stroke thrombectomy count jumps after 2015 landmark reports
HOUSTON – Use of endovascular mechanical thrombectomy for treating selected patients with acute ischemic stroke surged in U.S. practice following publication of several studies in early 2015 that documented the treatment’s efficacy, in data collected by a large U.S. hospital registry.
During April-June 2016, 3.5% of all acute ischemic stroke patients seen at the nearly 2,000 U.S. hospitals enrolled in the Get With the Guidelines-Stroke program underwent treatment with endovascular thrombectomy, up from the 2% rate at the end of 2014,The new data he reported also showed substantial increases for other measures of thrombectomy use during a roughly 18-month period that followed a flurry of reports in late 2014 and early 2015 that presented clear evidence of the safety and efficacy of thrombectomy for selected ischemic stroke patients. The percentage of hospitals participating in the Get With the Guidelines-Stroke program that performed thrombectomies increased from about a quarter of enrolled hospitals at the end of 2014 to almost a third by mid 2016, and the average quarterly number of endovascular thrombectomy cases at hospitals offering the procedure rose from about 7 during the final 3 months of 2014 to about 12 during July-September 2016, reported Dr. Smith, a neurologist and medical director of the Cognitive Neurosciences Clinic at the University of Calgary (Alta.).
“Before 2015, we saw a slow increase in the use of intra-arterial therapy, but after studies showed it was effective, there was an acceleration in the proportion of hospitals providing this therapy, the number of cases treated at each hospital, and the number of ischemic stroke patients treated,” Dr. Smith said in a video interview. “This shows rapid uptake of endovascular thrombectomy, but we still have a ways to go.”
He estimated that roughly 10%-15% of all U.S. acute ischemic stroke patients are eligible for endovascular thrombectomy based on location of the occluding clot in a large cerebral artery and the time frame when patients appear at a thrombectomy hospital relative to their stroke onset. This suggests that by mid-2016, roughly 20%-33% of U.S. ischemic stroke patients eligible for thrombectomy actually received the treatment.
“I don’t think we should be satisfied until we treat every eligible patient as quickly as we can. We need to move toward 100%,” he said.
The analyses he reported came from data collected on more than 2.4 million ischemic stroke patients treated at more than 2,200 U.S. hospitals participating in the Get With the Guidelines-Stroke program during 2003-2016.
The 2016 data also showed that, while the median thrombectomy annual case volume from mid-2015 to mid-2016 was 32 patients per year at thrombectomy hospitals, about 5% of these centers performed 100 or more cases during this 1-year period, and about 10% performed 10 or fewer thrombectomy cases. “There may be a relationship between case volume and the skill of performing the procedure, and a potential need for a volume minimum for thrombectomy certification to ensure that centers and operators maintain their skills,” Dr. Smith said.
He contrasted the recent pace of thrombectomy uptake with the first few years of routine thrombolytic treatment for the same disease during the mid-1990s, when little uptake occurred. Dr. Smith attributed the more robust penetration of thrombectomy to several factors: the impressive benefit of the treatment, the concurrent reporting of several confirmatory studies, and the stronger acute stroke–care infrastructure now in place, compared with what was available to stroke patients a generation ago.
“It’s encouraging to see such early growth in thrombectomy when thrombolysis lagged for so many years,” Dr. Smith said.
Dr. Smith had no disclosures. Get With the Guidelines-Stroke is a program of the American Heart Association and American Stroke Association using funding provided by several drug companies.
Eric E. Smith, MD, said at the International Stroke Conference, sponsored by the American Heart Association.
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
HOUSTON – Use of endovascular mechanical thrombectomy for treating selected patients with acute ischemic stroke surged in U.S. practice following publication of several studies in early 2015 that documented the treatment’s efficacy, in data collected by a large U.S. hospital registry.
During April-June 2016, 3.5% of all acute ischemic stroke patients seen at the nearly 2,000 U.S. hospitals enrolled in the Get With the Guidelines-Stroke program underwent treatment with endovascular thrombectomy, up from the 2% rate at the end of 2014,The new data he reported also showed substantial increases for other measures of thrombectomy use during a roughly 18-month period that followed a flurry of reports in late 2014 and early 2015 that presented clear evidence of the safety and efficacy of thrombectomy for selected ischemic stroke patients. The percentage of hospitals participating in the Get With the Guidelines-Stroke program that performed thrombectomies increased from about a quarter of enrolled hospitals at the end of 2014 to almost a third by mid 2016, and the average quarterly number of endovascular thrombectomy cases at hospitals offering the procedure rose from about 7 during the final 3 months of 2014 to about 12 during July-September 2016, reported Dr. Smith, a neurologist and medical director of the Cognitive Neurosciences Clinic at the University of Calgary (Alta.).
“Before 2015, we saw a slow increase in the use of intra-arterial therapy, but after studies showed it was effective, there was an acceleration in the proportion of hospitals providing this therapy, the number of cases treated at each hospital, and the number of ischemic stroke patients treated,” Dr. Smith said in a video interview. “This shows rapid uptake of endovascular thrombectomy, but we still have a ways to go.”
He estimated that roughly 10%-15% of all U.S. acute ischemic stroke patients are eligible for endovascular thrombectomy based on location of the occluding clot in a large cerebral artery and the time frame when patients appear at a thrombectomy hospital relative to their stroke onset. This suggests that by mid-2016, roughly 20%-33% of U.S. ischemic stroke patients eligible for thrombectomy actually received the treatment.
“I don’t think we should be satisfied until we treat every eligible patient as quickly as we can. We need to move toward 100%,” he said.
The analyses he reported came from data collected on more than 2.4 million ischemic stroke patients treated at more than 2,200 U.S. hospitals participating in the Get With the Guidelines-Stroke program during 2003-2016.
The 2016 data also showed that, while the median thrombectomy annual case volume from mid-2015 to mid-2016 was 32 patients per year at thrombectomy hospitals, about 5% of these centers performed 100 or more cases during this 1-year period, and about 10% performed 10 or fewer thrombectomy cases. “There may be a relationship between case volume and the skill of performing the procedure, and a potential need for a volume minimum for thrombectomy certification to ensure that centers and operators maintain their skills,” Dr. Smith said.
He contrasted the recent pace of thrombectomy uptake with the first few years of routine thrombolytic treatment for the same disease during the mid-1990s, when little uptake occurred. Dr. Smith attributed the more robust penetration of thrombectomy to several factors: the impressive benefit of the treatment, the concurrent reporting of several confirmatory studies, and the stronger acute stroke–care infrastructure now in place, compared with what was available to stroke patients a generation ago.
“It’s encouraging to see such early growth in thrombectomy when thrombolysis lagged for so many years,” Dr. Smith said.
Dr. Smith had no disclosures. Get With the Guidelines-Stroke is a program of the American Heart Association and American Stroke Association using funding provided by several drug companies.
Eric E. Smith, MD, said at the International Stroke Conference, sponsored by the American Heart Association.
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
HOUSTON – Use of endovascular mechanical thrombectomy for treating selected patients with acute ischemic stroke surged in U.S. practice following publication of several studies in early 2015 that documented the treatment’s efficacy, in data collected by a large U.S. hospital registry.
During April-June 2016, 3.5% of all acute ischemic stroke patients seen at the nearly 2,000 U.S. hospitals enrolled in the Get With the Guidelines-Stroke program underwent treatment with endovascular thrombectomy, up from the 2% rate at the end of 2014,The new data he reported also showed substantial increases for other measures of thrombectomy use during a roughly 18-month period that followed a flurry of reports in late 2014 and early 2015 that presented clear evidence of the safety and efficacy of thrombectomy for selected ischemic stroke patients. The percentage of hospitals participating in the Get With the Guidelines-Stroke program that performed thrombectomies increased from about a quarter of enrolled hospitals at the end of 2014 to almost a third by mid 2016, and the average quarterly number of endovascular thrombectomy cases at hospitals offering the procedure rose from about 7 during the final 3 months of 2014 to about 12 during July-September 2016, reported Dr. Smith, a neurologist and medical director of the Cognitive Neurosciences Clinic at the University of Calgary (Alta.).
“Before 2015, we saw a slow increase in the use of intra-arterial therapy, but after studies showed it was effective, there was an acceleration in the proportion of hospitals providing this therapy, the number of cases treated at each hospital, and the number of ischemic stroke patients treated,” Dr. Smith said in a video interview. “This shows rapid uptake of endovascular thrombectomy, but we still have a ways to go.”
He estimated that roughly 10%-15% of all U.S. acute ischemic stroke patients are eligible for endovascular thrombectomy based on location of the occluding clot in a large cerebral artery and the time frame when patients appear at a thrombectomy hospital relative to their stroke onset. This suggests that by mid-2016, roughly 20%-33% of U.S. ischemic stroke patients eligible for thrombectomy actually received the treatment.
“I don’t think we should be satisfied until we treat every eligible patient as quickly as we can. We need to move toward 100%,” he said.
The analyses he reported came from data collected on more than 2.4 million ischemic stroke patients treated at more than 2,200 U.S. hospitals participating in the Get With the Guidelines-Stroke program during 2003-2016.
The 2016 data also showed that, while the median thrombectomy annual case volume from mid-2015 to mid-2016 was 32 patients per year at thrombectomy hospitals, about 5% of these centers performed 100 or more cases during this 1-year period, and about 10% performed 10 or fewer thrombectomy cases. “There may be a relationship between case volume and the skill of performing the procedure, and a potential need for a volume minimum for thrombectomy certification to ensure that centers and operators maintain their skills,” Dr. Smith said.
He contrasted the recent pace of thrombectomy uptake with the first few years of routine thrombolytic treatment for the same disease during the mid-1990s, when little uptake occurred. Dr. Smith attributed the more robust penetration of thrombectomy to several factors: the impressive benefit of the treatment, the concurrent reporting of several confirmatory studies, and the stronger acute stroke–care infrastructure now in place, compared with what was available to stroke patients a generation ago.
“It’s encouraging to see such early growth in thrombectomy when thrombolysis lagged for so many years,” Dr. Smith said.
Dr. Smith had no disclosures. Get With the Guidelines-Stroke is a program of the American Heart Association and American Stroke Association using funding provided by several drug companies.
Eric E. Smith, MD, said at the International Stroke Conference, sponsored by the American Heart Association.
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:
Major finding: U.S. thrombectomy treatment jumped from 2% of all acute ischemic stroke patients in late 2014 to 3.5% in mid-2016.
Data source: Hospitalization records for more than 2.4 million ischemic stroke patients treated at more than 2,200 U.S. hospitals participating in the Get With the Guidelines-Stroke program during 2003-2016.
Disclosures: Dr. Smith had no disclosures. Get With the Guidelines-Stroke is a program of the American Heart Association and American Stroke Association using funding provided by several drug companies.
Mobile stroke units becoming more common despite cost effectiveness questions
HOUSTON – Mobile stroke units – specially equipped ambulances that bring a diagnostic CT scanner and therapeutic thrombolysis directly to patients in the field – have begun to proliferate across the United States, although they remain investigational, with no clear proof of their incremental clinical value or cost effectiveness.
The first U.S. mobile stroke unit (MSU) launched in Houston in early 2014 (following the world’s first in Berlin, which began running in early 2011), and by early 2017, at least eight other U.S. MSUs were in operation, most of them put into service during the prior 15 months. U.S. MSU locations now include Cleveland; Denver; Memphis; New York; Toledo, Ohio; Trenton, N.J., and Northwestern Medicine and Rush University Medical Center in the western Chicago region. A tenth MSU is slated to start operation at the University of California, Los Angeles later this year.
Early data collected at some of these sites show that initiating care of an acute ischemic stroke patient in an MSU shaves precious minutes off the time it takes to start thrombolytic therapy with tissue plasminogen activator (tPA) compared with that at a hospital, and findings from preliminary analyses suggest better functional outcomes for patients treated this way. However, leaders in the nascent field readily admit that the data needed to clearly prove the benefit patients receive from operating MSUs are still a few years off. This uncertainty about the added benefit to patients from MSUs couples with one clear fact: MSUs are expensive to start up, with a price tag of roughly $1 million to get a MSU on the road for the first time, and also expensive to operate, with one estimate for the annual cost of keeping an MSU on the street at about $500,000 per year for staffing, supplies, and other expenses.
“Every U.S. MSU I know of started with philanthropic gifts, but you need a business model” to keep the program running long-term, James C. Grotta, MD, said during a session focused on MSUs at the International Stroke Conference sponsored by the American Heart Association. “You can’t sustain an MSU with philanthropy,” said Dr. Grotta, professor of neurology at the University of Texas Health Science Center in Houston, director and founder of the Houston MSU, and acknowledged godfather of all U.S. MSUs.
The concept behind MSUs is simple. Each one carries a CT scanner on board so that, once the vehicle’s staff identifies a patient with clinical signs of a significant–acute ischemic stroke in the field and confirms that the timing of the stroke onset suggests eligibility for tPA treatment, a CT scan can immediately be run on site to finalize tPA eligibility. The MSU staff can then begin infusing the drug in the ambulance as it speeds the patient to an appropriate hospital.
Another advantage to MSUs, in addition to quicker initiation of thrombolysis, is “getting patients to where they need to go faster and more directly,” said Dr. Nour.
“Instead of bringing patients first to a hospital that’s unable to do thrombectomy and where treatment gets slowed down, with an MSU you can give tPA on the street and go straight to a thrombectomy center,” agreed Jeffrey L. Saver, MD, professor of neurology and director of the stroke unit at UCLA. “The MSU offers the tantalizing possibility that you can give tPA with no time hit because you can give it on the way directly to a comprehensive stroke center,” Dr. Saver said during a session at the meeting.
Early data on effectiveness
Dr. Nour reported some of the best evidence for the incremental clinical benefit of MSUs based on the reduced time for starting a tPA infusion. She used data collected by the Berlin group and published in September 2016 that compared the treatment courses and outcomes of patients managed with an MSU with similar patients managed by conventional ambulance transport for whom CT scan assessment and the start of TPA treatment did not begin until the patient reached a hospital.
The German analysis showed that, in the observational Pre-Hospital Acute Neurological Therapy and Optimization of Medical Care in Stroke Patients–Study (PHANTOM-S), among 353 patients treated by conventional transport, the median time from stroke onset to thrombolysis was 112 minutes, compared with a median of 73 minutes among 305 patients managed with an MSU, a statistically significant difference. However, the study found no significant difference for its primary endpoint: the percentage of patients with a modified Rankin Scale score of 0-1 when measured 90 days after their respective strokes. This outcome occurred in 47% of the control patients managed conventionally and in 53% of those managed by an MSU, a difference that fell short of statistical significance (Lancet Neurol. 2016 Sept;15[10]:1035-43).
Dr. Nour attributed the lack of statistical significance for this primary endpoint to the relatively small number of patients enrolled in PHANTOM-S. “The study was underpowered,” she said.
Dr. Nour presented an analysis at the meeting that extrapolated the results out to 1,000 hypothetical patients and tallied the benefits that a larger number of patients could expect to receive if their outcomes paralleled those seen in the published results. It showed that, among 1,000 stroke patients treated with an MSU, 58 were expected to be free from disability 90 days later, and an additional 124 patients would have some improvement in their 90 day clinical outcome based on their modified Rankin Scale scores when compared with patients undergoing conventional hospitalization.
“If this finding was confirmed in a larger, controlled study, it would suggest that MSU-based thrombolysis has substantial clinical benefit,” she concluded.
Another recent report looked at the first 100 stroke patients treated by the Cleveland MSU during 2014. Researchers at the Cleveland Clinic and Case Western Reserve University said that 16 of those 100 patients received tPA, and the median time from their emergency call to thrombolytic treatment was 38.5 minutes faster than for 53 stroke patients treated during the same period at emergency departments operated by the Cleveland Clinic, a statistically significant difference. However, this report included no data on clinical outcomes (Neurology. 2017 March 8. doi: 10.1212/WNL.0000000000003786).
Running the financial numbers
Nailing down the incremental clinical benefit from MSUs is clearly a very important part of determining the value of this strategy, but another very practical concern is how much the service costs and whether it is financially sustainable.
“We did a cost-effectiveness analysis based on the PHANTOM-S data, and we were conservative by only looking at the benefit from early tPA treatment,” Heinrich J. Audebert, MD, professor of neurology at Charité Hospital in Berlin and head of the team running Berlin’s MSU, said during the MSU session at the meeting. “We did not take into account saving money by avoiding long-term stroke disability and just considered the cost of [immediate] care and the quality adjusted life years. We calculated a cost of $35,000 per quality adjusted life year, which is absolutely acceptable.”
He cautioned that this analysis was not based on actual outcomes but on the numbers needed to treat calculated from the PHANTOM-S results. “We need to now show this in controlled trials,” he admitted.
Income from transport reimbursement, currently $500 per trip, and reimbursements of $17,000 above costs for administering tPA and of roughly $40,000 above costs for performing thrombectomy are balancing these costs. Based on an estimated additional one thrombolysis case per month and one additional thrombectomy case per month, the MSU yields a potential incremental income to the hospital running the MSU of about $3.8 million over 5 years, enough to balance the operating cost, Dr. Grotta said.
A key part of controlling costs is having the neurologic consult done via a telemedicine link rather than by neurologist at the MSU. “Telemedicine reduces operational costs and improves efficiency,” noted M. Shazam Hussain, MD, interim director of the Cerebrovascular Center at the Cleveland Clinic. “Cost effectiveness is a very important part of the concept” of MSUs, he said at the session.
The Houston group reported results from a study that directly compared the diagnostic performance of an onboard neurologist with that of a telemedicine neurologist linked in remotely during MSU deployments for 174 patients. For these cases, the two neurologists each made an independent diagnosis that the researchers then compared. The two diagnoses concurred for 88% of the cases, Tzu-Ching Wu, MD, reported at the meeting. This rate of agreement matched the incidence of concordance between two neurologists who independently assessed the same patients at the hospital (Stroke. 2017 Jan;48[1]:222-4), said Dr. Wu, a vascular neurologist and director of the telemedicine program at the University of Texas Health Science Center in Houston.
“The results support using telemedicine as the primary means of assessment on the MSU,” said Dr. Wu. “This may enhance MSU efficiency and reduce costs.” His group’s next study of MSU telemedicine will compare the time needed to make a diagnostic decision using the two approaches, something not formally examined in the study he reported.
However, telemedicine assessment of CT results gathered in a MSU has one major limitation: the time needed to transmit the huge amount of information in a CT angiogram.
The MSU used by clinicians at the University of Tennessee, Memphis, incorporates an extremely powerful battery that enables “full CT scanner capability with a moving gantry,” said Andrei V. Alexandrov, MD, professor and chairman of neurology at the university. With this set up “we can do in-the-field multiphasic CT–angiography from the aortic arch up within 4 minutes. The challenge of doing this is simple. It’s 1.7 gigabytes of data,” which would take a prohibitively long time to transmit from a remote site, he explained. As a result, the complete set of images from the field CT angiogram are delivered on a memory stick to the attending hospital neurologist once the MSU returns.
Waiting for more data
Despite these advances and the steady recent growth of MSUs, significant skepticism remains. “While mobile stroke units seem like a good idea and there is genuine hope that they will improve outcomes for selected stroke patients, there is not yet any evidence that this is the case,” wrote Bryan Bledsoe, DO, in a January 2017 editorial in the Journal of Emergency Medical Services. “They are expensive and financially non-sustainable. Without widespread deployment, they stand to benefit few, if any, patients. The money spent on these devices would be better spent on improving the current EMS system including paramedic education, the availability of stroke centers, and on the early recognition of ELVO [emergent large vessel occlusion] strokes,” wrote Dr. Bledsoe, professor of emergency medicine at the University of Nevada in Las Vegas.
Two other experts voiced concerns about MSUs in an editorial that accompanied a Cleveland Clinic report in March. “Even if MSUs meet an acceptable societal threshold for cost effectiveness, cost efficiency may prove a taller order to achieve return on investment for individual health systems and communities,” wrote Andrew M. Southerland, MD, and Ethan S. Brandler, MD (Neurology. 2017 March 8. doi: 10.1212/WNL.0000000000003833). They cited the Cleveland report, which noted that the group’s first 100 MSU-treated patients came from a total of 317 MSU deployments and included 217 trips that were canceled prior to the MSU’s arrival at the patient’s location. In Berlin’s initial experience, more than 2,000 MSU deployments led to 200 TPA treatments and 349 cancellations before arrival, noted Dr. Southerland, a neurologist at the University of Virginia in Charlottesville, and Dr. Brandler, an emergency medicine physician at Stony Brook (N.Y.) University.
“Hope remains that future trials may demonstrate the ultimate potential of mobile stroke units to improve long-term outcomes for more patients by treating them more quickly and effectively. In the meantime, ongoing efforts are needed to streamline MSU cost and efficiency,” they wrote.
Proponents of MSUs agree that what’s needed now are more data to prove efficacy and cost effectiveness, as well as better integration into EMS programs. The first opportunity for documenting the clinical impact of MSUs on larger numbers of U.S. patients may be from the BEnefits of Stroke Treatment Delivered using a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services (BEST-MSU) Study, funded by the Patient-Centered Outcomes Research Institute. This study is collecting data from the MSU programs in Denver Houston, and Memphis. Although currently designed to enroll 697 patients, Dr. Grotta said he hopes to kick that up to 1,000 patients.
“We are following the healthcare use and its cost for every enrolled MSU and conventional patient for 1 year,” Dr. Grotta explained in an interview. He hopes these results will provide the data needed to move MSUs from investigational status to routine and reimbursable care.
Dr. Southerland and Dr. Brandler suggested that “making MSUs multipurpose vehicles might also enhance cost-effectiveness,” an option that Dr. Grotta and his colleagues embrace. The MSUs on U.S. roads already also treat patients with intracranial hemorrhages using blood pressure reduction medications. Other neurologic diagnoses considered potential targets for MSU interventions include encephalopathy, seizures, central nervous system–tumors, and infections.
Stroke is a prime example of “a disease that is extremely time sensitive, and for the first time the field of stroke is ahead of the rest of the medical world in trying to speed treatment,” Dr. Grotta said. “We could add other diagnostic equipment monitored by telemedicine specialists. The MSU concept could be expanded to make it much more cost effective” and spur wider adoption by EMS, he suggested.
Dr. Grotta is a consultant to Frazer, a company that produces mobile stroke units, and to Stryker Corporation, and he has received research support from Genentech. Dr. Saver has been a consultant to and received research support from St. Jude. Dr. Audebert has received honoraria from Pfizer, Boehringer Ingelheim, Bristol-Myers Squibb, and Ever Pharma. He has been a consultant to ReNeuron, and he has served as an expert witness for Pfizer and for Lundbeck. Dr. Hussain has been a consultant to Pulsar. Dr. Alexandrov has been a speaker for Genentech. Dr. Nour, Dr. Wu, Dr. Bledsoe, Dr. Southerland, and Dr. Brandler had no disclosures.
[email protected]
On Twitter @mitchelzoler
HOUSTON – Mobile stroke units – specially equipped ambulances that bring a diagnostic CT scanner and therapeutic thrombolysis directly to patients in the field – have begun to proliferate across the United States, although they remain investigational, with no clear proof of their incremental clinical value or cost effectiveness.
The first U.S. mobile stroke unit (MSU) launched in Houston in early 2014 (following the world’s first in Berlin, which began running in early 2011), and by early 2017, at least eight other U.S. MSUs were in operation, most of them put into service during the prior 15 months. U.S. MSU locations now include Cleveland; Denver; Memphis; New York; Toledo, Ohio; Trenton, N.J., and Northwestern Medicine and Rush University Medical Center in the western Chicago region. A tenth MSU is slated to start operation at the University of California, Los Angeles later this year.
Early data collected at some of these sites show that initiating care of an acute ischemic stroke patient in an MSU shaves precious minutes off the time it takes to start thrombolytic therapy with tissue plasminogen activator (tPA) compared with that at a hospital, and findings from preliminary analyses suggest better functional outcomes for patients treated this way. However, leaders in the nascent field readily admit that the data needed to clearly prove the benefit patients receive from operating MSUs are still a few years off. This uncertainty about the added benefit to patients from MSUs couples with one clear fact: MSUs are expensive to start up, with a price tag of roughly $1 million to get a MSU on the road for the first time, and also expensive to operate, with one estimate for the annual cost of keeping an MSU on the street at about $500,000 per year for staffing, supplies, and other expenses.
“Every U.S. MSU I know of started with philanthropic gifts, but you need a business model” to keep the program running long-term, James C. Grotta, MD, said during a session focused on MSUs at the International Stroke Conference sponsored by the American Heart Association. “You can’t sustain an MSU with philanthropy,” said Dr. Grotta, professor of neurology at the University of Texas Health Science Center in Houston, director and founder of the Houston MSU, and acknowledged godfather of all U.S. MSUs.
The concept behind MSUs is simple. Each one carries a CT scanner on board so that, once the vehicle’s staff identifies a patient with clinical signs of a significant–acute ischemic stroke in the field and confirms that the timing of the stroke onset suggests eligibility for tPA treatment, a CT scan can immediately be run on site to finalize tPA eligibility. The MSU staff can then begin infusing the drug in the ambulance as it speeds the patient to an appropriate hospital.
Another advantage to MSUs, in addition to quicker initiation of thrombolysis, is “getting patients to where they need to go faster and more directly,” said Dr. Nour.
“Instead of bringing patients first to a hospital that’s unable to do thrombectomy and where treatment gets slowed down, with an MSU you can give tPA on the street and go straight to a thrombectomy center,” agreed Jeffrey L. Saver, MD, professor of neurology and director of the stroke unit at UCLA. “The MSU offers the tantalizing possibility that you can give tPA with no time hit because you can give it on the way directly to a comprehensive stroke center,” Dr. Saver said during a session at the meeting.
Early data on effectiveness
Dr. Nour reported some of the best evidence for the incremental clinical benefit of MSUs based on the reduced time for starting a tPA infusion. She used data collected by the Berlin group and published in September 2016 that compared the treatment courses and outcomes of patients managed with an MSU with similar patients managed by conventional ambulance transport for whom CT scan assessment and the start of TPA treatment did not begin until the patient reached a hospital.
The German analysis showed that, in the observational Pre-Hospital Acute Neurological Therapy and Optimization of Medical Care in Stroke Patients–Study (PHANTOM-S), among 353 patients treated by conventional transport, the median time from stroke onset to thrombolysis was 112 minutes, compared with a median of 73 minutes among 305 patients managed with an MSU, a statistically significant difference. However, the study found no significant difference for its primary endpoint: the percentage of patients with a modified Rankin Scale score of 0-1 when measured 90 days after their respective strokes. This outcome occurred in 47% of the control patients managed conventionally and in 53% of those managed by an MSU, a difference that fell short of statistical significance (Lancet Neurol. 2016 Sept;15[10]:1035-43).
Dr. Nour attributed the lack of statistical significance for this primary endpoint to the relatively small number of patients enrolled in PHANTOM-S. “The study was underpowered,” she said.
Dr. Nour presented an analysis at the meeting that extrapolated the results out to 1,000 hypothetical patients and tallied the benefits that a larger number of patients could expect to receive if their outcomes paralleled those seen in the published results. It showed that, among 1,000 stroke patients treated with an MSU, 58 were expected to be free from disability 90 days later, and an additional 124 patients would have some improvement in their 90 day clinical outcome based on their modified Rankin Scale scores when compared with patients undergoing conventional hospitalization.
“If this finding was confirmed in a larger, controlled study, it would suggest that MSU-based thrombolysis has substantial clinical benefit,” she concluded.
Another recent report looked at the first 100 stroke patients treated by the Cleveland MSU during 2014. Researchers at the Cleveland Clinic and Case Western Reserve University said that 16 of those 100 patients received tPA, and the median time from their emergency call to thrombolytic treatment was 38.5 minutes faster than for 53 stroke patients treated during the same period at emergency departments operated by the Cleveland Clinic, a statistically significant difference. However, this report included no data on clinical outcomes (Neurology. 2017 March 8. doi: 10.1212/WNL.0000000000003786).
Running the financial numbers
Nailing down the incremental clinical benefit from MSUs is clearly a very important part of determining the value of this strategy, but another very practical concern is how much the service costs and whether it is financially sustainable.
“We did a cost-effectiveness analysis based on the PHANTOM-S data, and we were conservative by only looking at the benefit from early tPA treatment,” Heinrich J. Audebert, MD, professor of neurology at Charité Hospital in Berlin and head of the team running Berlin’s MSU, said during the MSU session at the meeting. “We did not take into account saving money by avoiding long-term stroke disability and just considered the cost of [immediate] care and the quality adjusted life years. We calculated a cost of $35,000 per quality adjusted life year, which is absolutely acceptable.”
He cautioned that this analysis was not based on actual outcomes but on the numbers needed to treat calculated from the PHANTOM-S results. “We need to now show this in controlled trials,” he admitted.
Income from transport reimbursement, currently $500 per trip, and reimbursements of $17,000 above costs for administering tPA and of roughly $40,000 above costs for performing thrombectomy are balancing these costs. Based on an estimated additional one thrombolysis case per month and one additional thrombectomy case per month, the MSU yields a potential incremental income to the hospital running the MSU of about $3.8 million over 5 years, enough to balance the operating cost, Dr. Grotta said.
A key part of controlling costs is having the neurologic consult done via a telemedicine link rather than by neurologist at the MSU. “Telemedicine reduces operational costs and improves efficiency,” noted M. Shazam Hussain, MD, interim director of the Cerebrovascular Center at the Cleveland Clinic. “Cost effectiveness is a very important part of the concept” of MSUs, he said at the session.
The Houston group reported results from a study that directly compared the diagnostic performance of an onboard neurologist with that of a telemedicine neurologist linked in remotely during MSU deployments for 174 patients. For these cases, the two neurologists each made an independent diagnosis that the researchers then compared. The two diagnoses concurred for 88% of the cases, Tzu-Ching Wu, MD, reported at the meeting. This rate of agreement matched the incidence of concordance between two neurologists who independently assessed the same patients at the hospital (Stroke. 2017 Jan;48[1]:222-4), said Dr. Wu, a vascular neurologist and director of the telemedicine program at the University of Texas Health Science Center in Houston.
“The results support using telemedicine as the primary means of assessment on the MSU,” said Dr. Wu. “This may enhance MSU efficiency and reduce costs.” His group’s next study of MSU telemedicine will compare the time needed to make a diagnostic decision using the two approaches, something not formally examined in the study he reported.
However, telemedicine assessment of CT results gathered in a MSU has one major limitation: the time needed to transmit the huge amount of information in a CT angiogram.
The MSU used by clinicians at the University of Tennessee, Memphis, incorporates an extremely powerful battery that enables “full CT scanner capability with a moving gantry,” said Andrei V. Alexandrov, MD, professor and chairman of neurology at the university. With this set up “we can do in-the-field multiphasic CT–angiography from the aortic arch up within 4 minutes. The challenge of doing this is simple. It’s 1.7 gigabytes of data,” which would take a prohibitively long time to transmit from a remote site, he explained. As a result, the complete set of images from the field CT angiogram are delivered on a memory stick to the attending hospital neurologist once the MSU returns.
Waiting for more data
Despite these advances and the steady recent growth of MSUs, significant skepticism remains. “While mobile stroke units seem like a good idea and there is genuine hope that they will improve outcomes for selected stroke patients, there is not yet any evidence that this is the case,” wrote Bryan Bledsoe, DO, in a January 2017 editorial in the Journal of Emergency Medical Services. “They are expensive and financially non-sustainable. Without widespread deployment, they stand to benefit few, if any, patients. The money spent on these devices would be better spent on improving the current EMS system including paramedic education, the availability of stroke centers, and on the early recognition of ELVO [emergent large vessel occlusion] strokes,” wrote Dr. Bledsoe, professor of emergency medicine at the University of Nevada in Las Vegas.
Two other experts voiced concerns about MSUs in an editorial that accompanied a Cleveland Clinic report in March. “Even if MSUs meet an acceptable societal threshold for cost effectiveness, cost efficiency may prove a taller order to achieve return on investment for individual health systems and communities,” wrote Andrew M. Southerland, MD, and Ethan S. Brandler, MD (Neurology. 2017 March 8. doi: 10.1212/WNL.0000000000003833). They cited the Cleveland report, which noted that the group’s first 100 MSU-treated patients came from a total of 317 MSU deployments and included 217 trips that were canceled prior to the MSU’s arrival at the patient’s location. In Berlin’s initial experience, more than 2,000 MSU deployments led to 200 TPA treatments and 349 cancellations before arrival, noted Dr. Southerland, a neurologist at the University of Virginia in Charlottesville, and Dr. Brandler, an emergency medicine physician at Stony Brook (N.Y.) University.
“Hope remains that future trials may demonstrate the ultimate potential of mobile stroke units to improve long-term outcomes for more patients by treating them more quickly and effectively. In the meantime, ongoing efforts are needed to streamline MSU cost and efficiency,” they wrote.
Proponents of MSUs agree that what’s needed now are more data to prove efficacy and cost effectiveness, as well as better integration into EMS programs. The first opportunity for documenting the clinical impact of MSUs on larger numbers of U.S. patients may be from the BEnefits of Stroke Treatment Delivered using a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services (BEST-MSU) Study, funded by the Patient-Centered Outcomes Research Institute. This study is collecting data from the MSU programs in Denver Houston, and Memphis. Although currently designed to enroll 697 patients, Dr. Grotta said he hopes to kick that up to 1,000 patients.
“We are following the healthcare use and its cost for every enrolled MSU and conventional patient for 1 year,” Dr. Grotta explained in an interview. He hopes these results will provide the data needed to move MSUs from investigational status to routine and reimbursable care.
Dr. Southerland and Dr. Brandler suggested that “making MSUs multipurpose vehicles might also enhance cost-effectiveness,” an option that Dr. Grotta and his colleagues embrace. The MSUs on U.S. roads already also treat patients with intracranial hemorrhages using blood pressure reduction medications. Other neurologic diagnoses considered potential targets for MSU interventions include encephalopathy, seizures, central nervous system–tumors, and infections.
Stroke is a prime example of “a disease that is extremely time sensitive, and for the first time the field of stroke is ahead of the rest of the medical world in trying to speed treatment,” Dr. Grotta said. “We could add other diagnostic equipment monitored by telemedicine specialists. The MSU concept could be expanded to make it much more cost effective” and spur wider adoption by EMS, he suggested.
Dr. Grotta is a consultant to Frazer, a company that produces mobile stroke units, and to Stryker Corporation, and he has received research support from Genentech. Dr. Saver has been a consultant to and received research support from St. Jude. Dr. Audebert has received honoraria from Pfizer, Boehringer Ingelheim, Bristol-Myers Squibb, and Ever Pharma. He has been a consultant to ReNeuron, and he has served as an expert witness for Pfizer and for Lundbeck. Dr. Hussain has been a consultant to Pulsar. Dr. Alexandrov has been a speaker for Genentech. Dr. Nour, Dr. Wu, Dr. Bledsoe, Dr. Southerland, and Dr. Brandler had no disclosures.
[email protected]
On Twitter @mitchelzoler
HOUSTON – Mobile stroke units – specially equipped ambulances that bring a diagnostic CT scanner and therapeutic thrombolysis directly to patients in the field – have begun to proliferate across the United States, although they remain investigational, with no clear proof of their incremental clinical value or cost effectiveness.
The first U.S. mobile stroke unit (MSU) launched in Houston in early 2014 (following the world’s first in Berlin, which began running in early 2011), and by early 2017, at least eight other U.S. MSUs were in operation, most of them put into service during the prior 15 months. U.S. MSU locations now include Cleveland; Denver; Memphis; New York; Toledo, Ohio; Trenton, N.J., and Northwestern Medicine and Rush University Medical Center in the western Chicago region. A tenth MSU is slated to start operation at the University of California, Los Angeles later this year.
Early data collected at some of these sites show that initiating care of an acute ischemic stroke patient in an MSU shaves precious minutes off the time it takes to start thrombolytic therapy with tissue plasminogen activator (tPA) compared with that at a hospital, and findings from preliminary analyses suggest better functional outcomes for patients treated this way. However, leaders in the nascent field readily admit that the data needed to clearly prove the benefit patients receive from operating MSUs are still a few years off. This uncertainty about the added benefit to patients from MSUs couples with one clear fact: MSUs are expensive to start up, with a price tag of roughly $1 million to get a MSU on the road for the first time, and also expensive to operate, with one estimate for the annual cost of keeping an MSU on the street at about $500,000 per year for staffing, supplies, and other expenses.
“Every U.S. MSU I know of started with philanthropic gifts, but you need a business model” to keep the program running long-term, James C. Grotta, MD, said during a session focused on MSUs at the International Stroke Conference sponsored by the American Heart Association. “You can’t sustain an MSU with philanthropy,” said Dr. Grotta, professor of neurology at the University of Texas Health Science Center in Houston, director and founder of the Houston MSU, and acknowledged godfather of all U.S. MSUs.
The concept behind MSUs is simple. Each one carries a CT scanner on board so that, once the vehicle’s staff identifies a patient with clinical signs of a significant–acute ischemic stroke in the field and confirms that the timing of the stroke onset suggests eligibility for tPA treatment, a CT scan can immediately be run on site to finalize tPA eligibility. The MSU staff can then begin infusing the drug in the ambulance as it speeds the patient to an appropriate hospital.
Another advantage to MSUs, in addition to quicker initiation of thrombolysis, is “getting patients to where they need to go faster and more directly,” said Dr. Nour.
“Instead of bringing patients first to a hospital that’s unable to do thrombectomy and where treatment gets slowed down, with an MSU you can give tPA on the street and go straight to a thrombectomy center,” agreed Jeffrey L. Saver, MD, professor of neurology and director of the stroke unit at UCLA. “The MSU offers the tantalizing possibility that you can give tPA with no time hit because you can give it on the way directly to a comprehensive stroke center,” Dr. Saver said during a session at the meeting.
Early data on effectiveness
Dr. Nour reported some of the best evidence for the incremental clinical benefit of MSUs based on the reduced time for starting a tPA infusion. She used data collected by the Berlin group and published in September 2016 that compared the treatment courses and outcomes of patients managed with an MSU with similar patients managed by conventional ambulance transport for whom CT scan assessment and the start of TPA treatment did not begin until the patient reached a hospital.
The German analysis showed that, in the observational Pre-Hospital Acute Neurological Therapy and Optimization of Medical Care in Stroke Patients–Study (PHANTOM-S), among 353 patients treated by conventional transport, the median time from stroke onset to thrombolysis was 112 minutes, compared with a median of 73 minutes among 305 patients managed with an MSU, a statistically significant difference. However, the study found no significant difference for its primary endpoint: the percentage of patients with a modified Rankin Scale score of 0-1 when measured 90 days after their respective strokes. This outcome occurred in 47% of the control patients managed conventionally and in 53% of those managed by an MSU, a difference that fell short of statistical significance (Lancet Neurol. 2016 Sept;15[10]:1035-43).
Dr. Nour attributed the lack of statistical significance for this primary endpoint to the relatively small number of patients enrolled in PHANTOM-S. “The study was underpowered,” she said.
Dr. Nour presented an analysis at the meeting that extrapolated the results out to 1,000 hypothetical patients and tallied the benefits that a larger number of patients could expect to receive if their outcomes paralleled those seen in the published results. It showed that, among 1,000 stroke patients treated with an MSU, 58 were expected to be free from disability 90 days later, and an additional 124 patients would have some improvement in their 90 day clinical outcome based on their modified Rankin Scale scores when compared with patients undergoing conventional hospitalization.
“If this finding was confirmed in a larger, controlled study, it would suggest that MSU-based thrombolysis has substantial clinical benefit,” she concluded.
Another recent report looked at the first 100 stroke patients treated by the Cleveland MSU during 2014. Researchers at the Cleveland Clinic and Case Western Reserve University said that 16 of those 100 patients received tPA, and the median time from their emergency call to thrombolytic treatment was 38.5 minutes faster than for 53 stroke patients treated during the same period at emergency departments operated by the Cleveland Clinic, a statistically significant difference. However, this report included no data on clinical outcomes (Neurology. 2017 March 8. doi: 10.1212/WNL.0000000000003786).
Running the financial numbers
Nailing down the incremental clinical benefit from MSUs is clearly a very important part of determining the value of this strategy, but another very practical concern is how much the service costs and whether it is financially sustainable.
“We did a cost-effectiveness analysis based on the PHANTOM-S data, and we were conservative by only looking at the benefit from early tPA treatment,” Heinrich J. Audebert, MD, professor of neurology at Charité Hospital in Berlin and head of the team running Berlin’s MSU, said during the MSU session at the meeting. “We did not take into account saving money by avoiding long-term stroke disability and just considered the cost of [immediate] care and the quality adjusted life years. We calculated a cost of $35,000 per quality adjusted life year, which is absolutely acceptable.”
He cautioned that this analysis was not based on actual outcomes but on the numbers needed to treat calculated from the PHANTOM-S results. “We need to now show this in controlled trials,” he admitted.
Income from transport reimbursement, currently $500 per trip, and reimbursements of $17,000 above costs for administering tPA and of roughly $40,000 above costs for performing thrombectomy are balancing these costs. Based on an estimated additional one thrombolysis case per month and one additional thrombectomy case per month, the MSU yields a potential incremental income to the hospital running the MSU of about $3.8 million over 5 years, enough to balance the operating cost, Dr. Grotta said.
A key part of controlling costs is having the neurologic consult done via a telemedicine link rather than by neurologist at the MSU. “Telemedicine reduces operational costs and improves efficiency,” noted M. Shazam Hussain, MD, interim director of the Cerebrovascular Center at the Cleveland Clinic. “Cost effectiveness is a very important part of the concept” of MSUs, he said at the session.
The Houston group reported results from a study that directly compared the diagnostic performance of an onboard neurologist with that of a telemedicine neurologist linked in remotely during MSU deployments for 174 patients. For these cases, the two neurologists each made an independent diagnosis that the researchers then compared. The two diagnoses concurred for 88% of the cases, Tzu-Ching Wu, MD, reported at the meeting. This rate of agreement matched the incidence of concordance between two neurologists who independently assessed the same patients at the hospital (Stroke. 2017 Jan;48[1]:222-4), said Dr. Wu, a vascular neurologist and director of the telemedicine program at the University of Texas Health Science Center in Houston.
“The results support using telemedicine as the primary means of assessment on the MSU,” said Dr. Wu. “This may enhance MSU efficiency and reduce costs.” His group’s next study of MSU telemedicine will compare the time needed to make a diagnostic decision using the two approaches, something not formally examined in the study he reported.
However, telemedicine assessment of CT results gathered in a MSU has one major limitation: the time needed to transmit the huge amount of information in a CT angiogram.
The MSU used by clinicians at the University of Tennessee, Memphis, incorporates an extremely powerful battery that enables “full CT scanner capability with a moving gantry,” said Andrei V. Alexandrov, MD, professor and chairman of neurology at the university. With this set up “we can do in-the-field multiphasic CT–angiography from the aortic arch up within 4 minutes. The challenge of doing this is simple. It’s 1.7 gigabytes of data,” which would take a prohibitively long time to transmit from a remote site, he explained. As a result, the complete set of images from the field CT angiogram are delivered on a memory stick to the attending hospital neurologist once the MSU returns.
Waiting for more data
Despite these advances and the steady recent growth of MSUs, significant skepticism remains. “While mobile stroke units seem like a good idea and there is genuine hope that they will improve outcomes for selected stroke patients, there is not yet any evidence that this is the case,” wrote Bryan Bledsoe, DO, in a January 2017 editorial in the Journal of Emergency Medical Services. “They are expensive and financially non-sustainable. Without widespread deployment, they stand to benefit few, if any, patients. The money spent on these devices would be better spent on improving the current EMS system including paramedic education, the availability of stroke centers, and on the early recognition of ELVO [emergent large vessel occlusion] strokes,” wrote Dr. Bledsoe, professor of emergency medicine at the University of Nevada in Las Vegas.
Two other experts voiced concerns about MSUs in an editorial that accompanied a Cleveland Clinic report in March. “Even if MSUs meet an acceptable societal threshold for cost effectiveness, cost efficiency may prove a taller order to achieve return on investment for individual health systems and communities,” wrote Andrew M. Southerland, MD, and Ethan S. Brandler, MD (Neurology. 2017 March 8. doi: 10.1212/WNL.0000000000003833). They cited the Cleveland report, which noted that the group’s first 100 MSU-treated patients came from a total of 317 MSU deployments and included 217 trips that were canceled prior to the MSU’s arrival at the patient’s location. In Berlin’s initial experience, more than 2,000 MSU deployments led to 200 TPA treatments and 349 cancellations before arrival, noted Dr. Southerland, a neurologist at the University of Virginia in Charlottesville, and Dr. Brandler, an emergency medicine physician at Stony Brook (N.Y.) University.
“Hope remains that future trials may demonstrate the ultimate potential of mobile stroke units to improve long-term outcomes for more patients by treating them more quickly and effectively. In the meantime, ongoing efforts are needed to streamline MSU cost and efficiency,” they wrote.
Proponents of MSUs agree that what’s needed now are more data to prove efficacy and cost effectiveness, as well as better integration into EMS programs. The first opportunity for documenting the clinical impact of MSUs on larger numbers of U.S. patients may be from the BEnefits of Stroke Treatment Delivered using a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services (BEST-MSU) Study, funded by the Patient-Centered Outcomes Research Institute. This study is collecting data from the MSU programs in Denver Houston, and Memphis. Although currently designed to enroll 697 patients, Dr. Grotta said he hopes to kick that up to 1,000 patients.
“We are following the healthcare use and its cost for every enrolled MSU and conventional patient for 1 year,” Dr. Grotta explained in an interview. He hopes these results will provide the data needed to move MSUs from investigational status to routine and reimbursable care.
Dr. Southerland and Dr. Brandler suggested that “making MSUs multipurpose vehicles might also enhance cost-effectiveness,” an option that Dr. Grotta and his colleagues embrace. The MSUs on U.S. roads already also treat patients with intracranial hemorrhages using blood pressure reduction medications. Other neurologic diagnoses considered potential targets for MSU interventions include encephalopathy, seizures, central nervous system–tumors, and infections.
Stroke is a prime example of “a disease that is extremely time sensitive, and for the first time the field of stroke is ahead of the rest of the medical world in trying to speed treatment,” Dr. Grotta said. “We could add other diagnostic equipment monitored by telemedicine specialists. The MSU concept could be expanded to make it much more cost effective” and spur wider adoption by EMS, he suggested.
Dr. Grotta is a consultant to Frazer, a company that produces mobile stroke units, and to Stryker Corporation, and he has received research support from Genentech. Dr. Saver has been a consultant to and received research support from St. Jude. Dr. Audebert has received honoraria from Pfizer, Boehringer Ingelheim, Bristol-Myers Squibb, and Ever Pharma. He has been a consultant to ReNeuron, and he has served as an expert witness for Pfizer and for Lundbeck. Dr. Hussain has been a consultant to Pulsar. Dr. Alexandrov has been a speaker for Genentech. Dr. Nour, Dr. Wu, Dr. Bledsoe, Dr. Southerland, and Dr. Brandler had no disclosures.
[email protected]
On Twitter @mitchelzoler
EXPERT ANALYSIS FROM THE INTERNATIONAL STROKE CONFERENCE
Ticagrelor improves platelet reactivity, but not clinical outcomes, in Chinese stroke patients
HOUSTON – The combination of ticagrelor and aspirin reduced the incidence of high on-treatment platelet reactivity compared with clopidogrel plus aspirin in an interim analysis of a trial of patients with minor acute ischemic stroke or high-risk transient ischemic attack, but was associated with more treatment-limiting side effects.
Significantly more patients taking the ticagrelor combination dropped out because of dyspnea and minor bleeding, Yilong Wang, MD, said at the International Stroke Conference, sponsored by the American Heart Association. Although the ticagrelor combination also prevented a few more recurrent strokes than did clopidogrel plus aspirin, the difference was not statistically significant.
Dr. Wang of Beijing Tiantan Hospital reported the results as part of an interim safety and efficacy analysis of the Platelet Reactivity in Acute Stroke or Transient Ischemic Attack (PRINCE) trial.
“Ticagrelor has been shown to be more effective in acute coronary syndromes than clopidogrel, regardless of genotype, as it is primarily metabolized by the cytochrome P3A4 enzyme,” Dr. Wang said. “In the SOCRATES Asian substudy, we saw a trend of better efficacy in reducing the risk of subsequent vascular events in the ticagrelor group. But there are limited data on the safety and efficacy of ticagrelor, compared with clopidogrel, over background aspirin in stroke patients.”
PRINCE sought to determine the safety of ticagrelor plus aspirin and their effect on platelet reactivity and clinical outcomes in Asian patients who had experienced a minor stroke or high-risk transient ischemic attack (TIA). The 90-day trial is being conducted in 26 centers in China. Its primary endpoints are P2Y12 reaction units (PRU) and the number of patients with high on-treatment platelet reactivity. Secondary outcomes were the incidence of stroke at 90 days, and a composite vascular outcome of any stroke, heart attack, or vascular death within 90 days.
The primary safety outcomes were major and minor bleeding, intracerebral hemorrhage, and total mortality. The study’s researchers hope to enroll 952 patients. The interim analysis was conducted in 476 who have completed the treatment and follow-up period.
The ticagrelor group (237) received an initial loading dose of 180 mg with 100-300 mg aspirin on day 1, followed by 180 mg ticagrelor plus 100 mg aspirin for 21 days. Thereafter, they discontinued the aspirin and continued with 180 mg ticagrelor.
The clopidogrel group (239) received a 300-mg clopidogrel loading dose plus 100-300 mg aspirin on day 1, followed by 75 mg clopidogrel and 100 mg aspirin daily for 21 days. Thereafter they discontinued the aspirin and took 75 mg clopidogrel daily.
Patients were a median of 60 years old. Most (75%) were male. The median blood pressure was 152/90; 60% were hypertensive. About a quarter had diabetes. The qualifying stroke was a TIA in 22%; the rest had a minor ischemic stroke. The median National Institutes of Health Stroke Scale score was 2.
Platelet function was measured at baseline and 2 hours after the initial loading dose, and then again at 24 hours, and at 7, 21, and 90 days.
The baseline PRU was about 250 in each group. Two hours after the loading dose, it dropped significantly more among those taking ticagrelor than in those on clopidogrel (45.7 vs. 222.32). It remained significantly lower at every time point. At 90 days, the PRU favored ticagrelor (69 vs. 175).
Ticagrelor was also associated with significantly less high on-treatment platelet reactivity at every time point. The final separation at 90 days significantly favored ticagrelor (13% vs. 30%).
Clinical endpoints numerically favored ticagrelor, although none of the findings were statistically significant. Any stroke occurred in 4.6% of the ticagrelor group and 7.5% of the clopidogrel group. The rate of ischemic stroke was 4.2% and 6.7%, respectively.
There were three deaths: two in the ticagrelor and one in the clopidogrel group, and three major bleeds in each group. There was no significant difference in minor bleeding or intracerebral hemorrhage. However, ticagrelor was associated with significantly more incidents of minimal bleeding (17% vs. 7%). This difference drove the final, statistically significant doubling of bleeding risk associated with ticagrelor (hazard ratio, 2.26).
There were 49 adverse events leading to dropouts. Most of these were due to bleeding, which was significantly higher in those taking ticagrelor (12 vs. 5 events). Dyspnea was the next-leading cause of study dropout (5 vs. 1 case). The remainder of the dropouts were due to study noncompliance and patient decisions.
The study will continue, Dr. Wang noted.
PRINCE is being sponsored by the Chinese government. Dr. Wang had no financial disclosures. AstraZeneca is providing the study drug at no charge, and is not otherwise involved in the trial.
[email protected]
On Twitter @alz_gal
HOUSTON – The combination of ticagrelor and aspirin reduced the incidence of high on-treatment platelet reactivity compared with clopidogrel plus aspirin in an interim analysis of a trial of patients with minor acute ischemic stroke or high-risk transient ischemic attack, but was associated with more treatment-limiting side effects.
Significantly more patients taking the ticagrelor combination dropped out because of dyspnea and minor bleeding, Yilong Wang, MD, said at the International Stroke Conference, sponsored by the American Heart Association. Although the ticagrelor combination also prevented a few more recurrent strokes than did clopidogrel plus aspirin, the difference was not statistically significant.
Dr. Wang of Beijing Tiantan Hospital reported the results as part of an interim safety and efficacy analysis of the Platelet Reactivity in Acute Stroke or Transient Ischemic Attack (PRINCE) trial.
“Ticagrelor has been shown to be more effective in acute coronary syndromes than clopidogrel, regardless of genotype, as it is primarily metabolized by the cytochrome P3A4 enzyme,” Dr. Wang said. “In the SOCRATES Asian substudy, we saw a trend of better efficacy in reducing the risk of subsequent vascular events in the ticagrelor group. But there are limited data on the safety and efficacy of ticagrelor, compared with clopidogrel, over background aspirin in stroke patients.”
PRINCE sought to determine the safety of ticagrelor plus aspirin and their effect on platelet reactivity and clinical outcomes in Asian patients who had experienced a minor stroke or high-risk transient ischemic attack (TIA). The 90-day trial is being conducted in 26 centers in China. Its primary endpoints are P2Y12 reaction units (PRU) and the number of patients with high on-treatment platelet reactivity. Secondary outcomes were the incidence of stroke at 90 days, and a composite vascular outcome of any stroke, heart attack, or vascular death within 90 days.
The primary safety outcomes were major and minor bleeding, intracerebral hemorrhage, and total mortality. The study’s researchers hope to enroll 952 patients. The interim analysis was conducted in 476 who have completed the treatment and follow-up period.
The ticagrelor group (237) received an initial loading dose of 180 mg with 100-300 mg aspirin on day 1, followed by 180 mg ticagrelor plus 100 mg aspirin for 21 days. Thereafter, they discontinued the aspirin and continued with 180 mg ticagrelor.
The clopidogrel group (239) received a 300-mg clopidogrel loading dose plus 100-300 mg aspirin on day 1, followed by 75 mg clopidogrel and 100 mg aspirin daily for 21 days. Thereafter they discontinued the aspirin and took 75 mg clopidogrel daily.
Patients were a median of 60 years old. Most (75%) were male. The median blood pressure was 152/90; 60% were hypertensive. About a quarter had diabetes. The qualifying stroke was a TIA in 22%; the rest had a minor ischemic stroke. The median National Institutes of Health Stroke Scale score was 2.
Platelet function was measured at baseline and 2 hours after the initial loading dose, and then again at 24 hours, and at 7, 21, and 90 days.
The baseline PRU was about 250 in each group. Two hours after the loading dose, it dropped significantly more among those taking ticagrelor than in those on clopidogrel (45.7 vs. 222.32). It remained significantly lower at every time point. At 90 days, the PRU favored ticagrelor (69 vs. 175).
Ticagrelor was also associated with significantly less high on-treatment platelet reactivity at every time point. The final separation at 90 days significantly favored ticagrelor (13% vs. 30%).
Clinical endpoints numerically favored ticagrelor, although none of the findings were statistically significant. Any stroke occurred in 4.6% of the ticagrelor group and 7.5% of the clopidogrel group. The rate of ischemic stroke was 4.2% and 6.7%, respectively.
There were three deaths: two in the ticagrelor and one in the clopidogrel group, and three major bleeds in each group. There was no significant difference in minor bleeding or intracerebral hemorrhage. However, ticagrelor was associated with significantly more incidents of minimal bleeding (17% vs. 7%). This difference drove the final, statistically significant doubling of bleeding risk associated with ticagrelor (hazard ratio, 2.26).
There were 49 adverse events leading to dropouts. Most of these were due to bleeding, which was significantly higher in those taking ticagrelor (12 vs. 5 events). Dyspnea was the next-leading cause of study dropout (5 vs. 1 case). The remainder of the dropouts were due to study noncompliance and patient decisions.
The study will continue, Dr. Wang noted.
PRINCE is being sponsored by the Chinese government. Dr. Wang had no financial disclosures. AstraZeneca is providing the study drug at no charge, and is not otherwise involved in the trial.
[email protected]
On Twitter @alz_gal
HOUSTON – The combination of ticagrelor and aspirin reduced the incidence of high on-treatment platelet reactivity compared with clopidogrel plus aspirin in an interim analysis of a trial of patients with minor acute ischemic stroke or high-risk transient ischemic attack, but was associated with more treatment-limiting side effects.
Significantly more patients taking the ticagrelor combination dropped out because of dyspnea and minor bleeding, Yilong Wang, MD, said at the International Stroke Conference, sponsored by the American Heart Association. Although the ticagrelor combination also prevented a few more recurrent strokes than did clopidogrel plus aspirin, the difference was not statistically significant.
Dr. Wang of Beijing Tiantan Hospital reported the results as part of an interim safety and efficacy analysis of the Platelet Reactivity in Acute Stroke or Transient Ischemic Attack (PRINCE) trial.
“Ticagrelor has been shown to be more effective in acute coronary syndromes than clopidogrel, regardless of genotype, as it is primarily metabolized by the cytochrome P3A4 enzyme,” Dr. Wang said. “In the SOCRATES Asian substudy, we saw a trend of better efficacy in reducing the risk of subsequent vascular events in the ticagrelor group. But there are limited data on the safety and efficacy of ticagrelor, compared with clopidogrel, over background aspirin in stroke patients.”
PRINCE sought to determine the safety of ticagrelor plus aspirin and their effect on platelet reactivity and clinical outcomes in Asian patients who had experienced a minor stroke or high-risk transient ischemic attack (TIA). The 90-day trial is being conducted in 26 centers in China. Its primary endpoints are P2Y12 reaction units (PRU) and the number of patients with high on-treatment platelet reactivity. Secondary outcomes were the incidence of stroke at 90 days, and a composite vascular outcome of any stroke, heart attack, or vascular death within 90 days.
The primary safety outcomes were major and minor bleeding, intracerebral hemorrhage, and total mortality. The study’s researchers hope to enroll 952 patients. The interim analysis was conducted in 476 who have completed the treatment and follow-up period.
The ticagrelor group (237) received an initial loading dose of 180 mg with 100-300 mg aspirin on day 1, followed by 180 mg ticagrelor plus 100 mg aspirin for 21 days. Thereafter, they discontinued the aspirin and continued with 180 mg ticagrelor.
The clopidogrel group (239) received a 300-mg clopidogrel loading dose plus 100-300 mg aspirin on day 1, followed by 75 mg clopidogrel and 100 mg aspirin daily for 21 days. Thereafter they discontinued the aspirin and took 75 mg clopidogrel daily.
Patients were a median of 60 years old. Most (75%) were male. The median blood pressure was 152/90; 60% were hypertensive. About a quarter had diabetes. The qualifying stroke was a TIA in 22%; the rest had a minor ischemic stroke. The median National Institutes of Health Stroke Scale score was 2.
Platelet function was measured at baseline and 2 hours after the initial loading dose, and then again at 24 hours, and at 7, 21, and 90 days.
The baseline PRU was about 250 in each group. Two hours after the loading dose, it dropped significantly more among those taking ticagrelor than in those on clopidogrel (45.7 vs. 222.32). It remained significantly lower at every time point. At 90 days, the PRU favored ticagrelor (69 vs. 175).
Ticagrelor was also associated with significantly less high on-treatment platelet reactivity at every time point. The final separation at 90 days significantly favored ticagrelor (13% vs. 30%).
Clinical endpoints numerically favored ticagrelor, although none of the findings were statistically significant. Any stroke occurred in 4.6% of the ticagrelor group and 7.5% of the clopidogrel group. The rate of ischemic stroke was 4.2% and 6.7%, respectively.
There were three deaths: two in the ticagrelor and one in the clopidogrel group, and three major bleeds in each group. There was no significant difference in minor bleeding or intracerebral hemorrhage. However, ticagrelor was associated with significantly more incidents of minimal bleeding (17% vs. 7%). This difference drove the final, statistically significant doubling of bleeding risk associated with ticagrelor (hazard ratio, 2.26).
There were 49 adverse events leading to dropouts. Most of these were due to bleeding, which was significantly higher in those taking ticagrelor (12 vs. 5 events). Dyspnea was the next-leading cause of study dropout (5 vs. 1 case). The remainder of the dropouts were due to study noncompliance and patient decisions.
The study will continue, Dr. Wang noted.
PRINCE is being sponsored by the Chinese government. Dr. Wang had no financial disclosures. AstraZeneca is providing the study drug at no charge, and is not otherwise involved in the trial.
[email protected]
On Twitter @alz_gal
AT THE INTERNATIONAL STROKE CONFERENCE
Key clinical point:
Major finding: At 90 days, P2Y12 reaction units favored ticagrelor (69 vs. 175).
Data source: The interim analysis of the PRINCE trial comprised 476 patients with minor acute ischemic stroke or high-risk transient ischemic attack.
Disclosures: PRINCE is being sponsored by the Chinese government. Dr. Wang had no financial disclosures. AstraZeneca is providing the study drug at no charge, and is not otherwise involved in the trial.
Vagus nerve stimulation shows stroke recovery promise
HOUSTON – Stroke patients with arm weakness had a clinically significant boost in arm function after about 19 weeks on a rehabilitation program that combined vagus nerve stimulation with rehabilitation training sessions in a multicenter, randomized, and sham-controlled proof-of-concept study with 17 patients.
This promising result follows a prior 21-patient study with a similar design and results (Stroke. 2016 Jan;47[1]:143-50), making the next step a pivotal trial with about 120 randomized patients that should start in 2017, Jesse Dawson, MD, said at the International Stroke Conference sponsored by the American Heart Association.
Results in the new study showed that eight poststroke patients with arm weakness who received a prolonged course of vagus nerve stimulation (VNS) and rehabilitation training had an average boost from baseline in their upper-extremity Fugl-Meyer score of 9.5 points measured 132 days after the start of the regimen, compared with an average 3.8-point rise among nine similar patients who underwent the same rehabilitation training but without VNS. A rise of 4-7 points on the upper-extremity Fugl-Meyer score is considered clinically significant for chronic stroke patients (J Physiotherapy. 2017 Jan;63[1]:53). The difference in mean scores between the VNS and control groups after 132 days was statistically significant for a secondary endpoint of the study.
The study’s primary endpoint, the difference between the control and VNS patients in mean upper-extremity Fugl-Meyer scores at the end of the initial phase of the study – a 6-week supervised training period – was 7.6 points in the VNS recipients and 5.3 points for the control patients, a difference that was not statistically significant.
The 9.5-point boost in average scores with more prolonged treatment and follow-up in the VNS patients is “highly likely to be clinically significant,” Dr. Dawson said. “We would like to see an effect earlier, with clinically important effects after 6 weeks of treatment. That would make the intervention easier to translate into clinical practice.”
The study ran at three U.S. centers and in Glasgow and enrolled patients who were 4 months to 5 years out from their index stroke and had moderate to severe arm weakness based on an upper-extremity Fugl-Meyer score of 20-50. The average age of the 17 patients in the study was 60 years. They were an average of 1.5 years removed from their index stroke.
All of the patients received an implanted device to produce VNS. The eight patients in the active arm received VNS during their 2-hour, thrice-weekly rehabilitation training sessions for the first 6 weeks of the study, with about 400 individual stimulations delivered during each training session. The nine controls received brief VNS to aid blinding, but had no meaningful VNS while they replicated the rehabilitation training regimen of the intervention group. At the end of 6 weeks, no training or VNS was done for 30 days. Then for the next 60 days, all patients did a daily program of unsupervised home rehabilitation exercises and patients in the intervention arm also self-administered 30 minutes of VNS daily.
The 17 patients who received a VNS device implant had three serious adverse events, Dr. Dawson reported: one infection, one episode of dyspnea, and one episode of vocal cord paralysis. None of the adverse events were judged definitely or likely linked to the stimulator, and all three effects were in control patients. In several patients in both arms, nonserious adverse effects occurred that are expected for the surgery used, including bruising, pain, swelling, and scarring. When the study ended, patients originally randomized to the sham group underwent active intervention with VNS and subsequently had an average 13-point increase on their upper extremity Fugl-Meyer score.
MicroTransponder, the company developing the vagus nerve stimulation device, funded the study. Dr. Dawson has received travel and meeting cost reimbursements from MicroTransponder, and several coauthors are employees of the company.
[email protected]
On Twitter @mitchelzoler
Arm weakness is a critical complication for patients after a stroke and is a great target for intervention. Patients with moderate to severe arm weakness such as those enrolled in this trial are seriously affected by their loss of arm function. It’s bad for patients when they cannot use an arm.
These new results are obviously exploratory, but they create a lot of hope.
Philip B. Gorelick, MD, is medical director of the Hauenstein Neuroscience Center of Saint Mary’s Health Care in Grand Rapids, Mich., and professor of translational science and molecular medicine at Michigan State University, Grand Rapids. He had no disclosures. He made these comments during a press conference.
Arm weakness is a critical complication for patients after a stroke and is a great target for intervention. Patients with moderate to severe arm weakness such as those enrolled in this trial are seriously affected by their loss of arm function. It’s bad for patients when they cannot use an arm.
These new results are obviously exploratory, but they create a lot of hope.
Philip B. Gorelick, MD, is medical director of the Hauenstein Neuroscience Center of Saint Mary’s Health Care in Grand Rapids, Mich., and professor of translational science and molecular medicine at Michigan State University, Grand Rapids. He had no disclosures. He made these comments during a press conference.
Arm weakness is a critical complication for patients after a stroke and is a great target for intervention. Patients with moderate to severe arm weakness such as those enrolled in this trial are seriously affected by their loss of arm function. It’s bad for patients when they cannot use an arm.
These new results are obviously exploratory, but they create a lot of hope.
Philip B. Gorelick, MD, is medical director of the Hauenstein Neuroscience Center of Saint Mary’s Health Care in Grand Rapids, Mich., and professor of translational science and molecular medicine at Michigan State University, Grand Rapids. He had no disclosures. He made these comments during a press conference.
HOUSTON – Stroke patients with arm weakness had a clinically significant boost in arm function after about 19 weeks on a rehabilitation program that combined vagus nerve stimulation with rehabilitation training sessions in a multicenter, randomized, and sham-controlled proof-of-concept study with 17 patients.
This promising result follows a prior 21-patient study with a similar design and results (Stroke. 2016 Jan;47[1]:143-50), making the next step a pivotal trial with about 120 randomized patients that should start in 2017, Jesse Dawson, MD, said at the International Stroke Conference sponsored by the American Heart Association.
Results in the new study showed that eight poststroke patients with arm weakness who received a prolonged course of vagus nerve stimulation (VNS) and rehabilitation training had an average boost from baseline in their upper-extremity Fugl-Meyer score of 9.5 points measured 132 days after the start of the regimen, compared with an average 3.8-point rise among nine similar patients who underwent the same rehabilitation training but without VNS. A rise of 4-7 points on the upper-extremity Fugl-Meyer score is considered clinically significant for chronic stroke patients (J Physiotherapy. 2017 Jan;63[1]:53). The difference in mean scores between the VNS and control groups after 132 days was statistically significant for a secondary endpoint of the study.
The study’s primary endpoint, the difference between the control and VNS patients in mean upper-extremity Fugl-Meyer scores at the end of the initial phase of the study – a 6-week supervised training period – was 7.6 points in the VNS recipients and 5.3 points for the control patients, a difference that was not statistically significant.
The 9.5-point boost in average scores with more prolonged treatment and follow-up in the VNS patients is “highly likely to be clinically significant,” Dr. Dawson said. “We would like to see an effect earlier, with clinically important effects after 6 weeks of treatment. That would make the intervention easier to translate into clinical practice.”
The study ran at three U.S. centers and in Glasgow and enrolled patients who were 4 months to 5 years out from their index stroke and had moderate to severe arm weakness based on an upper-extremity Fugl-Meyer score of 20-50. The average age of the 17 patients in the study was 60 years. They were an average of 1.5 years removed from their index stroke.
All of the patients received an implanted device to produce VNS. The eight patients in the active arm received VNS during their 2-hour, thrice-weekly rehabilitation training sessions for the first 6 weeks of the study, with about 400 individual stimulations delivered during each training session. The nine controls received brief VNS to aid blinding, but had no meaningful VNS while they replicated the rehabilitation training regimen of the intervention group. At the end of 6 weeks, no training or VNS was done for 30 days. Then for the next 60 days, all patients did a daily program of unsupervised home rehabilitation exercises and patients in the intervention arm also self-administered 30 minutes of VNS daily.
The 17 patients who received a VNS device implant had three serious adverse events, Dr. Dawson reported: one infection, one episode of dyspnea, and one episode of vocal cord paralysis. None of the adverse events were judged definitely or likely linked to the stimulator, and all three effects were in control patients. In several patients in both arms, nonserious adverse effects occurred that are expected for the surgery used, including bruising, pain, swelling, and scarring. When the study ended, patients originally randomized to the sham group underwent active intervention with VNS and subsequently had an average 13-point increase on their upper extremity Fugl-Meyer score.
MicroTransponder, the company developing the vagus nerve stimulation device, funded the study. Dr. Dawson has received travel and meeting cost reimbursements from MicroTransponder, and several coauthors are employees of the company.
[email protected]
On Twitter @mitchelzoler
HOUSTON – Stroke patients with arm weakness had a clinically significant boost in arm function after about 19 weeks on a rehabilitation program that combined vagus nerve stimulation with rehabilitation training sessions in a multicenter, randomized, and sham-controlled proof-of-concept study with 17 patients.
This promising result follows a prior 21-patient study with a similar design and results (Stroke. 2016 Jan;47[1]:143-50), making the next step a pivotal trial with about 120 randomized patients that should start in 2017, Jesse Dawson, MD, said at the International Stroke Conference sponsored by the American Heart Association.
Results in the new study showed that eight poststroke patients with arm weakness who received a prolonged course of vagus nerve stimulation (VNS) and rehabilitation training had an average boost from baseline in their upper-extremity Fugl-Meyer score of 9.5 points measured 132 days after the start of the regimen, compared with an average 3.8-point rise among nine similar patients who underwent the same rehabilitation training but without VNS. A rise of 4-7 points on the upper-extremity Fugl-Meyer score is considered clinically significant for chronic stroke patients (J Physiotherapy. 2017 Jan;63[1]:53). The difference in mean scores between the VNS and control groups after 132 days was statistically significant for a secondary endpoint of the study.
The study’s primary endpoint, the difference between the control and VNS patients in mean upper-extremity Fugl-Meyer scores at the end of the initial phase of the study – a 6-week supervised training period – was 7.6 points in the VNS recipients and 5.3 points for the control patients, a difference that was not statistically significant.
The 9.5-point boost in average scores with more prolonged treatment and follow-up in the VNS patients is “highly likely to be clinically significant,” Dr. Dawson said. “We would like to see an effect earlier, with clinically important effects after 6 weeks of treatment. That would make the intervention easier to translate into clinical practice.”
The study ran at three U.S. centers and in Glasgow and enrolled patients who were 4 months to 5 years out from their index stroke and had moderate to severe arm weakness based on an upper-extremity Fugl-Meyer score of 20-50. The average age of the 17 patients in the study was 60 years. They were an average of 1.5 years removed from their index stroke.
All of the patients received an implanted device to produce VNS. The eight patients in the active arm received VNS during their 2-hour, thrice-weekly rehabilitation training sessions for the first 6 weeks of the study, with about 400 individual stimulations delivered during each training session. The nine controls received brief VNS to aid blinding, but had no meaningful VNS while they replicated the rehabilitation training regimen of the intervention group. At the end of 6 weeks, no training or VNS was done for 30 days. Then for the next 60 days, all patients did a daily program of unsupervised home rehabilitation exercises and patients in the intervention arm also self-administered 30 minutes of VNS daily.
The 17 patients who received a VNS device implant had three serious adverse events, Dr. Dawson reported: one infection, one episode of dyspnea, and one episode of vocal cord paralysis. None of the adverse events were judged definitely or likely linked to the stimulator, and all three effects were in control patients. In several patients in both arms, nonserious adverse effects occurred that are expected for the surgery used, including bruising, pain, swelling, and scarring. When the study ended, patients originally randomized to the sham group underwent active intervention with VNS and subsequently had an average 13-point increase on their upper extremity Fugl-Meyer score.
MicroTransponder, the company developing the vagus nerve stimulation device, funded the study. Dr. Dawson has received travel and meeting cost reimbursements from MicroTransponder, and several coauthors are employees of the company.
[email protected]
On Twitter @mitchelzoler
AT THE INTERNATIONAL STROKE CONFERENCE
Key clinical point:
Major finding: Vagus nerve stimulation linked with a mean 9.5-point rise in upper-extremity Fugl-Meyer score at 132-day follow-up.
Data source: A multicenter, randomized, sham-controlled study with 17 chronic stroke patients.
Disclosures: MicroTransponder, the company developing the vagus nerve stimulation device, funded the study. Dr. Dawson has received travel and meeting cost reimbursements from MicroTransponder, and several coauthors are employees of the company.
Protocol speeds thrombectomy stroke patients from primary centers
HOUSTON – A novel protocol designed to speed patients with large-vessel occlusion strokes in and out of primary stroke centers and on to centers where they can undergo definitive thrombectomy treatment produced significant improvements in treatment speed and outcomes among 22 Rhode Island patients managed with the full protocol.
Streamlining the path in and out of a primary stroke center is key for delivering mechanical thrombectomy as quickly as possible to patients with an emergent large vessel occlusion, said Ryan A. McTaggart, MD, at the International Stroke Conference sponsored by the American Heart Association. “Door-in door-out time should be the standard metric for all partnerships between primary and comprehensive stroke centers,” said Dr. McTaggart, a neuroradiologist at Rhode Island Hospital in Providence, the state’s only comprehensive stroke center.
• When a patient with a suspected large vessel occlusion with a Los Angeles Motor Score of 4 or 5 arrives soon after onset at the primary stroke center, a call immediately goes out to the EMS transfer center of Rhode Island Hospital to coordinate the transport that will move the patient from the primary center to the comprehensive when needed.
• The initial CT scan at the primary center is run as the definitive scan, including a conventional CT scan to rule out hemorrhage and allow intravenous thrombolytic therapy with tissue plasminogen activator (TPA) and CT angiography to locate the occluding clot.
• The CT images are immediately uploaded to a cloud-based library so that neurologists at Rhode Island Hospital can read the images on their phones and plan the management strategy.
During the 11 months following the start of the protocol, the Rhode Island network identified 70 patients as candidates for thrombectomy, including 22 managed using the complete protocol and 48 managed using only parts of the new protocol.
The median time from onset of stroke symptoms to revascularization with thrombectomy was 184 minutes in the 22 patients managed under the full protocol and 233 minutes among 48 similar patients who were not fully managed with the protocol, Dr. McTaggart reported. This “dramatic” difference in median times was entirely driven by a difference in the door-in door-out time at the primary stroke center, which was a median of 64 minutes for the 22 patients managed with the full protocol and a median of 104 minutes without the full protocol, a 38% relative decrease that was statistically significant.
Time to initiation of intravenous TPA at the primary stroke center also improved, from a median of 65 minutes without the full protocol to a median of 40 minutes with it, a statistically significant difference. “The primary stroke center physicians tell us they have greater confidence to start TPA when they have a consult that can identify the patient’s clot,” he said.
Consistent with the shorter time to revascularization, the prevalence after 90 days of a functionally good outcome – a modified Rankin scale score of 0-2 – occurred in 50% of patients managed with the full protocol and 25% of those managed with a partial protocol, a statistically significant difference.
To put the 184 minutes median time from stroke onset to reperfusion into perspective, Dr. McTaggart noted that it is comparable to the time to reperfusion documented recently in a U.S. registry of thrombectomy patients who had been transported directly to the comprehensive stroke centers where their thrombectomy was done.
He also acknowledged the heavy lifting he and his associates had to do to set up this network. Getting buy-in from all the regional primary strokes centers was “a ton of work,” Dr. McTaggart said in an interview. “We told the primary stroke center staffs that thrombectomy is a powerful treatment, with a number needed to treat of three to get one improved outcome. That’s a convincing argument. The thrombectomy data [that became available in early 2015] made the argument for the protocol and network more compelling.”
Primary stroke centers keep the stroke patients who don’t have a clot occlusion suitable for thrombectomy, which means the comprehensive center thrombectomy team receives fewer false-alarm patients. Dr. McTaggart’s current goal is to have primary stroke centers get incoming patients out and on the road to a thrombectomy center within 45 minutes. In the future, primary stroke centers will perform CT imaging on all patients with suspected strokes, not just the severely affected patients with a Los Angeles Motor Score of 4 or 5. Additional useful steps toward speeding appropriate stroke patients to thrombectomy is direct ambulance transport of selected, high probability patients directly to a comprehensive stroke center and use of mobile stroke units to bring CT imaging and the start of TPA treatment out into the field.
Dr. McTaggart had no disclosures.
[email protected]
On Twitter @mitchelzoler
HOUSTON – A novel protocol designed to speed patients with large-vessel occlusion strokes in and out of primary stroke centers and on to centers where they can undergo definitive thrombectomy treatment produced significant improvements in treatment speed and outcomes among 22 Rhode Island patients managed with the full protocol.
Streamlining the path in and out of a primary stroke center is key for delivering mechanical thrombectomy as quickly as possible to patients with an emergent large vessel occlusion, said Ryan A. McTaggart, MD, at the International Stroke Conference sponsored by the American Heart Association. “Door-in door-out time should be the standard metric for all partnerships between primary and comprehensive stroke centers,” said Dr. McTaggart, a neuroradiologist at Rhode Island Hospital in Providence, the state’s only comprehensive stroke center.
• When a patient with a suspected large vessel occlusion with a Los Angeles Motor Score of 4 or 5 arrives soon after onset at the primary stroke center, a call immediately goes out to the EMS transfer center of Rhode Island Hospital to coordinate the transport that will move the patient from the primary center to the comprehensive when needed.
• The initial CT scan at the primary center is run as the definitive scan, including a conventional CT scan to rule out hemorrhage and allow intravenous thrombolytic therapy with tissue plasminogen activator (TPA) and CT angiography to locate the occluding clot.
• The CT images are immediately uploaded to a cloud-based library so that neurologists at Rhode Island Hospital can read the images on their phones and plan the management strategy.
During the 11 months following the start of the protocol, the Rhode Island network identified 70 patients as candidates for thrombectomy, including 22 managed using the complete protocol and 48 managed using only parts of the new protocol.
The median time from onset of stroke symptoms to revascularization with thrombectomy was 184 minutes in the 22 patients managed under the full protocol and 233 minutes among 48 similar patients who were not fully managed with the protocol, Dr. McTaggart reported. This “dramatic” difference in median times was entirely driven by a difference in the door-in door-out time at the primary stroke center, which was a median of 64 minutes for the 22 patients managed with the full protocol and a median of 104 minutes without the full protocol, a 38% relative decrease that was statistically significant.
Time to initiation of intravenous TPA at the primary stroke center also improved, from a median of 65 minutes without the full protocol to a median of 40 minutes with it, a statistically significant difference. “The primary stroke center physicians tell us they have greater confidence to start TPA when they have a consult that can identify the patient’s clot,” he said.
Consistent with the shorter time to revascularization, the prevalence after 90 days of a functionally good outcome – a modified Rankin scale score of 0-2 – occurred in 50% of patients managed with the full protocol and 25% of those managed with a partial protocol, a statistically significant difference.
To put the 184 minutes median time from stroke onset to reperfusion into perspective, Dr. McTaggart noted that it is comparable to the time to reperfusion documented recently in a U.S. registry of thrombectomy patients who had been transported directly to the comprehensive stroke centers where their thrombectomy was done.
He also acknowledged the heavy lifting he and his associates had to do to set up this network. Getting buy-in from all the regional primary strokes centers was “a ton of work,” Dr. McTaggart said in an interview. “We told the primary stroke center staffs that thrombectomy is a powerful treatment, with a number needed to treat of three to get one improved outcome. That’s a convincing argument. The thrombectomy data [that became available in early 2015] made the argument for the protocol and network more compelling.”
Primary stroke centers keep the stroke patients who don’t have a clot occlusion suitable for thrombectomy, which means the comprehensive center thrombectomy team receives fewer false-alarm patients. Dr. McTaggart’s current goal is to have primary stroke centers get incoming patients out and on the road to a thrombectomy center within 45 minutes. In the future, primary stroke centers will perform CT imaging on all patients with suspected strokes, not just the severely affected patients with a Los Angeles Motor Score of 4 or 5. Additional useful steps toward speeding appropriate stroke patients to thrombectomy is direct ambulance transport of selected, high probability patients directly to a comprehensive stroke center and use of mobile stroke units to bring CT imaging and the start of TPA treatment out into the field.
Dr. McTaggart had no disclosures.
[email protected]
On Twitter @mitchelzoler
HOUSTON – A novel protocol designed to speed patients with large-vessel occlusion strokes in and out of primary stroke centers and on to centers where they can undergo definitive thrombectomy treatment produced significant improvements in treatment speed and outcomes among 22 Rhode Island patients managed with the full protocol.
Streamlining the path in and out of a primary stroke center is key for delivering mechanical thrombectomy as quickly as possible to patients with an emergent large vessel occlusion, said Ryan A. McTaggart, MD, at the International Stroke Conference sponsored by the American Heart Association. “Door-in door-out time should be the standard metric for all partnerships between primary and comprehensive stroke centers,” said Dr. McTaggart, a neuroradiologist at Rhode Island Hospital in Providence, the state’s only comprehensive stroke center.
• When a patient with a suspected large vessel occlusion with a Los Angeles Motor Score of 4 or 5 arrives soon after onset at the primary stroke center, a call immediately goes out to the EMS transfer center of Rhode Island Hospital to coordinate the transport that will move the patient from the primary center to the comprehensive when needed.
• The initial CT scan at the primary center is run as the definitive scan, including a conventional CT scan to rule out hemorrhage and allow intravenous thrombolytic therapy with tissue plasminogen activator (TPA) and CT angiography to locate the occluding clot.
• The CT images are immediately uploaded to a cloud-based library so that neurologists at Rhode Island Hospital can read the images on their phones and plan the management strategy.
During the 11 months following the start of the protocol, the Rhode Island network identified 70 patients as candidates for thrombectomy, including 22 managed using the complete protocol and 48 managed using only parts of the new protocol.
The median time from onset of stroke symptoms to revascularization with thrombectomy was 184 minutes in the 22 patients managed under the full protocol and 233 minutes among 48 similar patients who were not fully managed with the protocol, Dr. McTaggart reported. This “dramatic” difference in median times was entirely driven by a difference in the door-in door-out time at the primary stroke center, which was a median of 64 minutes for the 22 patients managed with the full protocol and a median of 104 minutes without the full protocol, a 38% relative decrease that was statistically significant.
Time to initiation of intravenous TPA at the primary stroke center also improved, from a median of 65 minutes without the full protocol to a median of 40 minutes with it, a statistically significant difference. “The primary stroke center physicians tell us they have greater confidence to start TPA when they have a consult that can identify the patient’s clot,” he said.
Consistent with the shorter time to revascularization, the prevalence after 90 days of a functionally good outcome – a modified Rankin scale score of 0-2 – occurred in 50% of patients managed with the full protocol and 25% of those managed with a partial protocol, a statistically significant difference.
To put the 184 minutes median time from stroke onset to reperfusion into perspective, Dr. McTaggart noted that it is comparable to the time to reperfusion documented recently in a U.S. registry of thrombectomy patients who had been transported directly to the comprehensive stroke centers where their thrombectomy was done.
He also acknowledged the heavy lifting he and his associates had to do to set up this network. Getting buy-in from all the regional primary strokes centers was “a ton of work,” Dr. McTaggart said in an interview. “We told the primary stroke center staffs that thrombectomy is a powerful treatment, with a number needed to treat of three to get one improved outcome. That’s a convincing argument. The thrombectomy data [that became available in early 2015] made the argument for the protocol and network more compelling.”
Primary stroke centers keep the stroke patients who don’t have a clot occlusion suitable for thrombectomy, which means the comprehensive center thrombectomy team receives fewer false-alarm patients. Dr. McTaggart’s current goal is to have primary stroke centers get incoming patients out and on the road to a thrombectomy center within 45 minutes. In the future, primary stroke centers will perform CT imaging on all patients with suspected strokes, not just the severely affected patients with a Los Angeles Motor Score of 4 or 5. Additional useful steps toward speeding appropriate stroke patients to thrombectomy is direct ambulance transport of selected, high probability patients directly to a comprehensive stroke center and use of mobile stroke units to bring CT imaging and the start of TPA treatment out into the field.
Dr. McTaggart had no disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE INTERNATIONAL STROKE CONFERENCE
Key clinical point:
Major finding: Median time from stroke onset to thrombectomy reperfusion was 184 minutes, including transfer between a primary and comprehensive stroke center.
Data source: Review of 70 acute ischemic stroke patients treated at Rhode Island Hospital.
Disclosures: Dr. McTaggart had no disclosures.
Patient transfer before thrombectomy worsens stroke outcomes
HOUSTON – Drip and ship may not be the most time-effective way to treat acute ischemic stroke patients who are candidates for endovascular thrombectomy.
Results from two separate real-world, observational studies showed that acute ischemic stroke patients with large vessel occlusions amenable to mechanical thrombectomy had significantly worse clinical outcomes when their management path included a stop at a primary stroke center followed by transfer to a comprehensive stroke center that had the capacity to perform thrombectomy, compared with going straight to the thrombectomy site.
The findings show “the system of care has room for improvement. Patients with large vessel occlusions clearly do better when we get them to mechanical thrombectomy as quickly as possible,” said Dr. Froehler, a vascular neurologist at Vanderbilt University in Nashville, Tenn. Thrombectomy “has a more powerful treatment effect than TPA [tissue plasminogen activator] and we need to adjust our standard of care to best deliver” thrombectomy, he said in an interview.
The study run by Dr. Froehler used data collected in the Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) registry, which began in 2014 and has data for 984 acute ischemic stroke patients with large vessel occlusions treated by mechanical thrombectomy seen at any of 55 U.S. centers. The series included 445 (45%) patients first seen as a primary stroke center and then transferred to a comprehensive center and 539 (55%) who went directly to a comprehensive stroke center (direct patients). Prior to thrombectomy, 628 of all patients (64%) received TPA, with a roughly similar percentage in both the transferred and direct patients.
The data showed that the median time from symptom onset to revascularization was 202 minutes among the direct patients and 312 minutes among those first seen at a primary stroke center and then transferred, a statistically significant difference. The average time difference per patient between the two subgroups was 100 minutes, Dr. Froehler reported.
This difference in time to reperfusion led directly to significant differences in functional outcomes after 90 days measured on the modified Rankin Scale (mRS). The percentage of patients with a mRS score of 0 or 1 (an excellent functional outcome) was 38% for the patients first seen at primary stroke centers and 47% in direct patients, a 47% relative rise in excellent outcomes among the direct patients. The percentage of patients with a mRS score of 0-2, which identifies functional independence post stroke, was 52% among transferred patients and 60% in direct patients, a 38% relative improvement for this outcome among direct patients.
The second study of stroke transfer times and outcomes used data from 562 acute ischemic stroke patients with large vessel occlusions treated in the Providence Health & Services system in five western U.S. states during 2012-2016. Nearly half the patients required a transfer and the other half went directly to a center able to perform thrombectomy. The analysis used clinical outcomes scored on the mRS at the time of hospital discharge.
“Right now, the big delay at primary stroke centers is the door-in door-out time,” commented Ryan A. McTaggart, MD, an interventional neuroradiologist at Rhode Island Hospital in Providence, the only comprehensive stroke center in Rhode Island. He helped organize a partnership with 14 primary stroke centers in Rhode Island that uses a streamlined imaging, treatment (with TPA), and transfer protocol that hacked dozens of minutes off transfer times and produced a median time from onset of symptoms to revascularization by thrombectomy of 184 minutes in patients first seen at a primary stroke center. This clocking blows past the 202 minute median for stroke onset to revascularization in the direct patients from Dr. Froehler’s study.
Stroke transport and treatment networks are now undergoing refinement in Tennessee, said Dr. Froehler, based in part on the data he reported. Considerations in Tennessee include how EMS workers assess possible stroke patients, decisions by EMS on where to take patients, and how quality of care is measured at primary and comprehensive stroke centers.
The STRATIS registry is sponsored by Medtronic. Dr. Froehler is a consultant to Medtronic, Blockade, Stryker, and Control Medical. Dr. Smith, Dr. Tarpley, and Dr. McTaggart had no disclosures.
[email protected]
On Twitter @mitchelzoler
HOUSTON – Drip and ship may not be the most time-effective way to treat acute ischemic stroke patients who are candidates for endovascular thrombectomy.
Results from two separate real-world, observational studies showed that acute ischemic stroke patients with large vessel occlusions amenable to mechanical thrombectomy had significantly worse clinical outcomes when their management path included a stop at a primary stroke center followed by transfer to a comprehensive stroke center that had the capacity to perform thrombectomy, compared with going straight to the thrombectomy site.
The findings show “the system of care has room for improvement. Patients with large vessel occlusions clearly do better when we get them to mechanical thrombectomy as quickly as possible,” said Dr. Froehler, a vascular neurologist at Vanderbilt University in Nashville, Tenn. Thrombectomy “has a more powerful treatment effect than TPA [tissue plasminogen activator] and we need to adjust our standard of care to best deliver” thrombectomy, he said in an interview.
The study run by Dr. Froehler used data collected in the Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) registry, which began in 2014 and has data for 984 acute ischemic stroke patients with large vessel occlusions treated by mechanical thrombectomy seen at any of 55 U.S. centers. The series included 445 (45%) patients first seen as a primary stroke center and then transferred to a comprehensive center and 539 (55%) who went directly to a comprehensive stroke center (direct patients). Prior to thrombectomy, 628 of all patients (64%) received TPA, with a roughly similar percentage in both the transferred and direct patients.
The data showed that the median time from symptom onset to revascularization was 202 minutes among the direct patients and 312 minutes among those first seen at a primary stroke center and then transferred, a statistically significant difference. The average time difference per patient between the two subgroups was 100 minutes, Dr. Froehler reported.
This difference in time to reperfusion led directly to significant differences in functional outcomes after 90 days measured on the modified Rankin Scale (mRS). The percentage of patients with a mRS score of 0 or 1 (an excellent functional outcome) was 38% for the patients first seen at primary stroke centers and 47% in direct patients, a 47% relative rise in excellent outcomes among the direct patients. The percentage of patients with a mRS score of 0-2, which identifies functional independence post stroke, was 52% among transferred patients and 60% in direct patients, a 38% relative improvement for this outcome among direct patients.
The second study of stroke transfer times and outcomes used data from 562 acute ischemic stroke patients with large vessel occlusions treated in the Providence Health & Services system in five western U.S. states during 2012-2016. Nearly half the patients required a transfer and the other half went directly to a center able to perform thrombectomy. The analysis used clinical outcomes scored on the mRS at the time of hospital discharge.
“Right now, the big delay at primary stroke centers is the door-in door-out time,” commented Ryan A. McTaggart, MD, an interventional neuroradiologist at Rhode Island Hospital in Providence, the only comprehensive stroke center in Rhode Island. He helped organize a partnership with 14 primary stroke centers in Rhode Island that uses a streamlined imaging, treatment (with TPA), and transfer protocol that hacked dozens of minutes off transfer times and produced a median time from onset of symptoms to revascularization by thrombectomy of 184 minutes in patients first seen at a primary stroke center. This clocking blows past the 202 minute median for stroke onset to revascularization in the direct patients from Dr. Froehler’s study.
Stroke transport and treatment networks are now undergoing refinement in Tennessee, said Dr. Froehler, based in part on the data he reported. Considerations in Tennessee include how EMS workers assess possible stroke patients, decisions by EMS on where to take patients, and how quality of care is measured at primary and comprehensive stroke centers.
The STRATIS registry is sponsored by Medtronic. Dr. Froehler is a consultant to Medtronic, Blockade, Stryker, and Control Medical. Dr. Smith, Dr. Tarpley, and Dr. McTaggart had no disclosures.
[email protected]
On Twitter @mitchelzoler
HOUSTON – Drip and ship may not be the most time-effective way to treat acute ischemic stroke patients who are candidates for endovascular thrombectomy.
Results from two separate real-world, observational studies showed that acute ischemic stroke patients with large vessel occlusions amenable to mechanical thrombectomy had significantly worse clinical outcomes when their management path included a stop at a primary stroke center followed by transfer to a comprehensive stroke center that had the capacity to perform thrombectomy, compared with going straight to the thrombectomy site.
The findings show “the system of care has room for improvement. Patients with large vessel occlusions clearly do better when we get them to mechanical thrombectomy as quickly as possible,” said Dr. Froehler, a vascular neurologist at Vanderbilt University in Nashville, Tenn. Thrombectomy “has a more powerful treatment effect than TPA [tissue plasminogen activator] and we need to adjust our standard of care to best deliver” thrombectomy, he said in an interview.
The study run by Dr. Froehler used data collected in the Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) registry, which began in 2014 and has data for 984 acute ischemic stroke patients with large vessel occlusions treated by mechanical thrombectomy seen at any of 55 U.S. centers. The series included 445 (45%) patients first seen as a primary stroke center and then transferred to a comprehensive center and 539 (55%) who went directly to a comprehensive stroke center (direct patients). Prior to thrombectomy, 628 of all patients (64%) received TPA, with a roughly similar percentage in both the transferred and direct patients.
The data showed that the median time from symptom onset to revascularization was 202 minutes among the direct patients and 312 minutes among those first seen at a primary stroke center and then transferred, a statistically significant difference. The average time difference per patient between the two subgroups was 100 minutes, Dr. Froehler reported.
This difference in time to reperfusion led directly to significant differences in functional outcomes after 90 days measured on the modified Rankin Scale (mRS). The percentage of patients with a mRS score of 0 or 1 (an excellent functional outcome) was 38% for the patients first seen at primary stroke centers and 47% in direct patients, a 47% relative rise in excellent outcomes among the direct patients. The percentage of patients with a mRS score of 0-2, which identifies functional independence post stroke, was 52% among transferred patients and 60% in direct patients, a 38% relative improvement for this outcome among direct patients.
The second study of stroke transfer times and outcomes used data from 562 acute ischemic stroke patients with large vessel occlusions treated in the Providence Health & Services system in five western U.S. states during 2012-2016. Nearly half the patients required a transfer and the other half went directly to a center able to perform thrombectomy. The analysis used clinical outcomes scored on the mRS at the time of hospital discharge.
“Right now, the big delay at primary stroke centers is the door-in door-out time,” commented Ryan A. McTaggart, MD, an interventional neuroradiologist at Rhode Island Hospital in Providence, the only comprehensive stroke center in Rhode Island. He helped organize a partnership with 14 primary stroke centers in Rhode Island that uses a streamlined imaging, treatment (with TPA), and transfer protocol that hacked dozens of minutes off transfer times and produced a median time from onset of symptoms to revascularization by thrombectomy of 184 minutes in patients first seen at a primary stroke center. This clocking blows past the 202 minute median for stroke onset to revascularization in the direct patients from Dr. Froehler’s study.
Stroke transport and treatment networks are now undergoing refinement in Tennessee, said Dr. Froehler, based in part on the data he reported. Considerations in Tennessee include how EMS workers assess possible stroke patients, decisions by EMS on where to take patients, and how quality of care is measured at primary and comprehensive stroke centers.
The STRATIS registry is sponsored by Medtronic. Dr. Froehler is a consultant to Medtronic, Blockade, Stryker, and Control Medical. Dr. Smith, Dr. Tarpley, and Dr. McTaggart had no disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE INTERNATIONAL STROKE CONFERENCE
Key clinical point:
Major finding: In STRATIS, excellent outcomes occurred in 47% of patients sent directly to a thrombectomy hospital and in 38% of transferred patients.
Data source: The STRATIS registry, with 984 U.S. acute ischemic stroke patients, and 562 U.S. acute ischemic stroke patients from the Providence Health & Services network.
Disclosures: The STRATIS registry is sponsored by Medtronic. Dr. Froehler is a consultant to Medtronic, Blockade, Stryker, and Control Medical. Dr. Smith, Dr. Tarpley, and Dr. McTaggart had no disclosures.
Hemorrhagic stroke increases risk of depression and subsequent dementia
HOUSTON – Hemorrhagic stroke sharply increases the risk of new-onset depression which, in turn, is associated with a 30% increased risk of dementia within 5 years.
New-onset depression developed in 40% of intracerebral hemorrhage survivors in a large prospective study, Alessandro Biffi, MD, said at the International Stroke Conference sponsored by the American Heart Association. By the end of 5 years, 80% of these patients had developed some form of dementia.
“This is of great importance from a research and clinical standpoint, as it may represent a marker of ongoing cognitive deterioration,” said Dr. Biffi of Massachusetts General Hospital, Boston.
A number of studies have found that survivors of intracerebral hemorrhage (ICH) face a significantly increased risk of mood disorders and cognitive decline. “There is probably a link between mood disorders and cognition after ICH, as is the case for a number of other neurological conditions,” Dr. Biffi said. “Cerebrovascular small-vessel disease is likely to be involved in the underlying pathogenesis for these disorders, as it is also a risk factor for late-life depression in the general population. Therefore, depression and dementia after ICH may share some etiological connections.”
He and his colleagues enrolled 695 patients who had experienced an ICH and followed them for a mean of 5 years. None of the subjects had ever been diagnosed with a mood disorder or cognitive decline. The subjects were interviewed by telephone every 6 months.
At baseline, investigators collected CT and MRI imaging data, epidemiologic exposure data, and apolipoprotein E4 genotype. The outcomes were new-onset depression and incident dementia.
At baseline, subjects were a mean of 74 years old. About 70% had hypertension and 15% had heart disease. Less than 1% of the cohort was positive for the APOE e4 gene. Imaging-confirmed white matter disease was present in 65%.
Over the follow-up period, new-onset depression developed in 278 (40%). The temporal incidence of this was consistent, at about 7% per year.
Two baseline characteristics were significantly associated with new-onset depression. These included having more than a single copy of the APOE e4 allele (hazard ratio, 1.7) and the presence of white matter disease (HR, 1.82), Dr. Biffi reported.
Having had at least 10 years of school was protective against depression (HR, 0.75), as was functional independence (HR, 0.52).
By the end of the follow-up period, dementia had developed in 80% of those with depression (220). In 81% of cases, depression preceded dementia, with an average time lag of 1.5 years, he noted.
In a multivariate analysis, several factors were significantly associated with incident dementia. Higher education reduced the risk by 40% (HR, 0.60). Factors that increased the risk of dementia were black race (HR, 1.48), carrying the APOE e4 gene (HR, 2.12), presence of white matter disease (HR, 1.7), and poststroke new-onset depression (HR, 1.29).
The study shows only association, Dr. Biffi cautioned. “No causal relationship can be inferred by this study. We also can’t capture the severity of the mood symptoms, and we are unable to examine the relationship between cognition and apathy, which is another highly relevant neuropsychiatric manifestation of small-vessel disease.”
He had no financial disclosures.
[email protected]
On Twitter @alz_gal
HOUSTON – Hemorrhagic stroke sharply increases the risk of new-onset depression which, in turn, is associated with a 30% increased risk of dementia within 5 years.
New-onset depression developed in 40% of intracerebral hemorrhage survivors in a large prospective study, Alessandro Biffi, MD, said at the International Stroke Conference sponsored by the American Heart Association. By the end of 5 years, 80% of these patients had developed some form of dementia.
“This is of great importance from a research and clinical standpoint, as it may represent a marker of ongoing cognitive deterioration,” said Dr. Biffi of Massachusetts General Hospital, Boston.
A number of studies have found that survivors of intracerebral hemorrhage (ICH) face a significantly increased risk of mood disorders and cognitive decline. “There is probably a link between mood disorders and cognition after ICH, as is the case for a number of other neurological conditions,” Dr. Biffi said. “Cerebrovascular small-vessel disease is likely to be involved in the underlying pathogenesis for these disorders, as it is also a risk factor for late-life depression in the general population. Therefore, depression and dementia after ICH may share some etiological connections.”
He and his colleagues enrolled 695 patients who had experienced an ICH and followed them for a mean of 5 years. None of the subjects had ever been diagnosed with a mood disorder or cognitive decline. The subjects were interviewed by telephone every 6 months.
At baseline, investigators collected CT and MRI imaging data, epidemiologic exposure data, and apolipoprotein E4 genotype. The outcomes were new-onset depression and incident dementia.
At baseline, subjects were a mean of 74 years old. About 70% had hypertension and 15% had heart disease. Less than 1% of the cohort was positive for the APOE e4 gene. Imaging-confirmed white matter disease was present in 65%.
Over the follow-up period, new-onset depression developed in 278 (40%). The temporal incidence of this was consistent, at about 7% per year.
Two baseline characteristics were significantly associated with new-onset depression. These included having more than a single copy of the APOE e4 allele (hazard ratio, 1.7) and the presence of white matter disease (HR, 1.82), Dr. Biffi reported.
Having had at least 10 years of school was protective against depression (HR, 0.75), as was functional independence (HR, 0.52).
By the end of the follow-up period, dementia had developed in 80% of those with depression (220). In 81% of cases, depression preceded dementia, with an average time lag of 1.5 years, he noted.
In a multivariate analysis, several factors were significantly associated with incident dementia. Higher education reduced the risk by 40% (HR, 0.60). Factors that increased the risk of dementia were black race (HR, 1.48), carrying the APOE e4 gene (HR, 2.12), presence of white matter disease (HR, 1.7), and poststroke new-onset depression (HR, 1.29).
The study shows only association, Dr. Biffi cautioned. “No causal relationship can be inferred by this study. We also can’t capture the severity of the mood symptoms, and we are unable to examine the relationship between cognition and apathy, which is another highly relevant neuropsychiatric manifestation of small-vessel disease.”
He had no financial disclosures.
[email protected]
On Twitter @alz_gal
HOUSTON – Hemorrhagic stroke sharply increases the risk of new-onset depression which, in turn, is associated with a 30% increased risk of dementia within 5 years.
New-onset depression developed in 40% of intracerebral hemorrhage survivors in a large prospective study, Alessandro Biffi, MD, said at the International Stroke Conference sponsored by the American Heart Association. By the end of 5 years, 80% of these patients had developed some form of dementia.
“This is of great importance from a research and clinical standpoint, as it may represent a marker of ongoing cognitive deterioration,” said Dr. Biffi of Massachusetts General Hospital, Boston.
A number of studies have found that survivors of intracerebral hemorrhage (ICH) face a significantly increased risk of mood disorders and cognitive decline. “There is probably a link between mood disorders and cognition after ICH, as is the case for a number of other neurological conditions,” Dr. Biffi said. “Cerebrovascular small-vessel disease is likely to be involved in the underlying pathogenesis for these disorders, as it is also a risk factor for late-life depression in the general population. Therefore, depression and dementia after ICH may share some etiological connections.”
He and his colleagues enrolled 695 patients who had experienced an ICH and followed them for a mean of 5 years. None of the subjects had ever been diagnosed with a mood disorder or cognitive decline. The subjects were interviewed by telephone every 6 months.
At baseline, investigators collected CT and MRI imaging data, epidemiologic exposure data, and apolipoprotein E4 genotype. The outcomes were new-onset depression and incident dementia.
At baseline, subjects were a mean of 74 years old. About 70% had hypertension and 15% had heart disease. Less than 1% of the cohort was positive for the APOE e4 gene. Imaging-confirmed white matter disease was present in 65%.
Over the follow-up period, new-onset depression developed in 278 (40%). The temporal incidence of this was consistent, at about 7% per year.
Two baseline characteristics were significantly associated with new-onset depression. These included having more than a single copy of the APOE e4 allele (hazard ratio, 1.7) and the presence of white matter disease (HR, 1.82), Dr. Biffi reported.
Having had at least 10 years of school was protective against depression (HR, 0.75), as was functional independence (HR, 0.52).
By the end of the follow-up period, dementia had developed in 80% of those with depression (220). In 81% of cases, depression preceded dementia, with an average time lag of 1.5 years, he noted.
In a multivariate analysis, several factors were significantly associated with incident dementia. Higher education reduced the risk by 40% (HR, 0.60). Factors that increased the risk of dementia were black race (HR, 1.48), carrying the APOE e4 gene (HR, 2.12), presence of white matter disease (HR, 1.7), and poststroke new-onset depression (HR, 1.29).
The study shows only association, Dr. Biffi cautioned. “No causal relationship can be inferred by this study. We also can’t capture the severity of the mood symptoms, and we are unable to examine the relationship between cognition and apathy, which is another highly relevant neuropsychiatric manifestation of small-vessel disease.”
He had no financial disclosures.
[email protected]
On Twitter @alz_gal
AT THE INTERNATIONAL STROKE CONFERENCE
Key clinical point:
Major finding: Depression developed in 40% of survivors, with dementia developing in 80% of that group.
Data source: The prospective longitudinal study involved 695 patients.
Disclosures: Dr. Biffi had no financial disclosures.