Prehospital Care

Emergencies happen anywhere, anytime, and sometimes physicians find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a Medscape series telling these stories.

I was coming off a 48-hour shift plus a day of doing outpatient sedation at Sparrow Hospital in Lansing. It was December and Michigan-cold. The roads were fine – no snow – but I noticed an unusual amount of traffic on the freeway. Then I saw smoke coming from an overpass up ahead.

I drove on the side of the road where I wasn’t really supposed to and got closer. An SUV had crashed into one of the big concrete structures under the bridge. I saw people running around but wasn’t able to spot EMS or any health care workers. From where I was, I could identify four kids who had already been extricated and one adult still in the driver’s seat. I estimated the kids’ ages were around 7, 5, 3, and an infant who was a few months old. I left my car and went to help.

I was able to peg the ages correctly because I’m a pediatric critical care physician. As a specialty, we’re not commonly known. We oversee patient care in intensive care units, except the patients are children. Part of the job is that we’re experts at triaging. We recognize what’s life-threatening and less so.

The kids were with some adults who kept them warm with blankets. I examined each of them. The infant was asleep but arousable and acting like a normal baby. The 3-year-old boy was vomiting and appeared very fatigued. The 5-year-old boy had a forehead laceration and was in and out of consciousness. The 7-year-old girl was screaming because of different injuries.

While all of the children were concerning to me, I identified one in particular: the 5-year-old boy. It was obvious he needed serious medical attention and fast. So, I kept that little guy in mind. The others had sustained significant injuries, but my best guess was they could get to a hospital and be stabilized.

That said, I’m a trauma instructor, and one of the things I always tell trainees is: Trauma is a black box. On the outside, it may seem like a patient doesn’t have a lot of injuries. But underneath, there might be something worse, like a brain injury. Or the chest might have taken a blunt impact affecting the heart. There may be internal bleeding somewhere in the belly. It’s really hard to tease out what exactly is going on without equipment and testing.

I didn’t even have a pulse oximeter or heart rate monitor. I pretty much just went by the appearance of the child: pulse, heart rate, awareness, things like that.

After the kids, I moved to look at the man in the car. The front end had already caught fire. I could see the driver – the kids’ father, I guessed – unconscious and hunched over. I was wondering, Why hasn’t this guy been extricated?

I approached the car on the front passenger side. And then I just had this feeling. I knew I needed to step back. Immediately.

I did. And a few seconds later, the whole car exploded in flames.

I believe God is in control of everything. I tried to get to that man. But the scene was unsafe. Later I learned that several people, including a young nurse at the scene, had tried to get to him as well.

When EMS came, I identified myself. Obviously, these people do very, very important work. But they may be more used to the 60-year-old heart attack, the 25-year-old gunshot wound, the occasional ill child. I thought that four kids – each with possible critical poly-traumatic injuries – posed a challenge to anyone.

I told them, “This is what I do on a daily basis, and this is the kid I’m worried about the most. The other kids are definitely worrisome, but I would prioritize getting this kid to the hospital first. Can I ride with you?” They agreed.

We got that boy and his older sister into the first ambulance (she was in a lot of pain, the result of a femur fracture). The two other kids rode in the second ambulance. The hospital where I had just left was 10 minutes away. I called the other pediatric critical care doctor there, my partner. He thought I was calling for a routine issue – no such luck. I said, “I’m with four kids who are level-1 traumas in two ambulances and I’m heading to the hospital right now, ETA 10 minutes.”

En route, I thought the little boy might lose consciousness at any moment. He needed a breathing tube, and I debated whether it should be done in the ambulance vs. waiting until we got to the emergency room. Based on my judgment and his vital signs, I elected to wait to have it done it in a more controlled environment. Had I felt like he was in immediate need of an airway, I would’ve attempted it. But those are the tough calls that you must make.

My partner had alerted the trauma and emergency medicine teams at the hospital. By the time we arrived, my partner was down in the ER with the trauma team and ER staff. Everyone was ready. Then it was like divide and conquer. He attended to one of the kids. The ER team and I were with the little guy I was really worried about. We had his breathing tube in within minutes. The trauma team attended to the other two.

All the kids were stabilized and then admitted to the pediatric intensive care unit. I’m happy to say that all of them did well in the end. Even the little guy I was worried about the most.

I must say this incident gave me perspective on what EMS goes through. The field medicine we do in the United States is still in its infancy in a lot of ways. One of the things I would love to see in the future is a mobile ICU. After a critical illness hits, sometimes you only have seconds, minutes, maybe hours if you’re lucky. The earlier you can get patients the treatment they need, the better the outcomes.

I like taking care of critically ill children and their families. It fits my personality. And it’s a wonderful cause. But you have to be ready for tragic cases like this one. Yes, the children came out alive, but the accident claimed a life in a horrible way. And there was nothing I could do about it.

Critical care takes an emotional, psychological, and physical toll. It’s a roller coaster: Some kids do well; some kids don’t do well. All I can do is hold myself accountable. I keep my emotions in check, whether the outcome is positive or negative. And I do my best.
 

Mohamed Hani Farhat, MD, is a pediatric critical care physician at the University of Michigan C.S. Mott Children’s Hospital in Ann Arbor and Sparrow Hospital in Lansing, Mich. Are you a physician with a dramatic medical story outside the clinic? Medscape would love to consider your story for Is There a Doctor in the House? Please email your contact information and a short summary of your story to [email protected] . A version of this article appeared on Medscape.com.

Emergencies happen anywhere, anytime, and sometimes physicians find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a Medscape series telling these stories.

I was coming off a 48-hour shift plus a day of doing outpatient sedation at Sparrow Hospital in Lansing. It was December and Michigan-cold. The roads were fine – no snow – but I noticed an unusual amount of traffic on the freeway. Then I saw smoke coming from an overpass up ahead.

I drove on the side of the road where I wasn’t really supposed to and got closer. An SUV had crashed into one of the big concrete structures under the bridge. I saw people running around but wasn’t able to spot EMS or any health care workers. From where I was, I could identify four kids who had already been extricated and one adult still in the driver’s seat. I estimated the kids’ ages were around 7, 5, 3, and an infant who was a few months old. I left my car and went to help.

I was able to peg the ages correctly because I’m a pediatric critical care physician. As a specialty, we’re not commonly known. We oversee patient care in intensive care units, except the patients are children. Part of the job is that we’re experts at triaging. We recognize what’s life-threatening and less so.

The kids were with some adults who kept them warm with blankets. I examined each of them. The infant was asleep but arousable and acting like a normal baby. The 3-year-old boy was vomiting and appeared very fatigued. The 5-year-old boy had a forehead laceration and was in and out of consciousness. The 7-year-old girl was screaming because of different injuries.

While all of the children were concerning to me, I identified one in particular: the 5-year-old boy. It was obvious he needed serious medical attention and fast. So, I kept that little guy in mind. The others had sustained significant injuries, but my best guess was they could get to a hospital and be stabilized.

That said, I’m a trauma instructor, and one of the things I always tell trainees is: Trauma is a black box. On the outside, it may seem like a patient doesn’t have a lot of injuries. But underneath, there might be something worse, like a brain injury. Or the chest might have taken a blunt impact affecting the heart. There may be internal bleeding somewhere in the belly. It’s really hard to tease out what exactly is going on without equipment and testing.

I didn’t even have a pulse oximeter or heart rate monitor. I pretty much just went by the appearance of the child: pulse, heart rate, awareness, things like that.

After the kids, I moved to look at the man in the car. The front end had already caught fire. I could see the driver – the kids’ father, I guessed – unconscious and hunched over. I was wondering, Why hasn’t this guy been extricated?

I approached the car on the front passenger side. And then I just had this feeling. I knew I needed to step back. Immediately.

I did. And a few seconds later, the whole car exploded in flames.

I believe God is in control of everything. I tried to get to that man. But the scene was unsafe. Later I learned that several people, including a young nurse at the scene, had tried to get to him as well.

When EMS came, I identified myself. Obviously, these people do very, very important work. But they may be more used to the 60-year-old heart attack, the 25-year-old gunshot wound, the occasional ill child. I thought that four kids – each with possible critical poly-traumatic injuries – posed a challenge to anyone.

I told them, “This is what I do on a daily basis, and this is the kid I’m worried about the most. The other kids are definitely worrisome, but I would prioritize getting this kid to the hospital first. Can I ride with you?” They agreed.

We got that boy and his older sister into the first ambulance (she was in a lot of pain, the result of a femur fracture). The two other kids rode in the second ambulance. The hospital where I had just left was 10 minutes away. I called the other pediatric critical care doctor there, my partner. He thought I was calling for a routine issue – no such luck. I said, “I’m with four kids who are level-1 traumas in two ambulances and I’m heading to the hospital right now, ETA 10 minutes.”

En route, I thought the little boy might lose consciousness at any moment. He needed a breathing tube, and I debated whether it should be done in the ambulance vs. waiting until we got to the emergency room. Based on my judgment and his vital signs, I elected to wait to have it done it in a more controlled environment. Had I felt like he was in immediate need of an airway, I would’ve attempted it. But those are the tough calls that you must make.

My partner had alerted the trauma and emergency medicine teams at the hospital. By the time we arrived, my partner was down in the ER with the trauma team and ER staff. Everyone was ready. Then it was like divide and conquer. He attended to one of the kids. The ER team and I were with the little guy I was really worried about. We had his breathing tube in within minutes. The trauma team attended to the other two.

All the kids were stabilized and then admitted to the pediatric intensive care unit. I’m happy to say that all of them did well in the end. Even the little guy I was worried about the most.

I must say this incident gave me perspective on what EMS goes through. The field medicine we do in the United States is still in its infancy in a lot of ways. One of the things I would love to see in the future is a mobile ICU. After a critical illness hits, sometimes you only have seconds, minutes, maybe hours if you’re lucky. The earlier you can get patients the treatment they need, the better the outcomes.

I like taking care of critically ill children and their families. It fits my personality. And it’s a wonderful cause. But you have to be ready for tragic cases like this one. Yes, the children came out alive, but the accident claimed a life in a horrible way. And there was nothing I could do about it.

Critical care takes an emotional, psychological, and physical toll. It’s a roller coaster: Some kids do well; some kids don’t do well. All I can do is hold myself accountable. I keep my emotions in check, whether the outcome is positive or negative. And I do my best.
 

Mohamed Hani Farhat, MD, is a pediatric critical care physician at the University of Michigan C.S. Mott Children’s Hospital in Ann Arbor and Sparrow Hospital in Lansing, Mich. Are you a physician with a dramatic medical story outside the clinic? Medscape would love to consider your story for Is There a Doctor in the House? Please email your contact information and a short summary of your story to [email protected] . A version of this article appeared on Medscape.com.

Emergencies happen anywhere, anytime, and sometimes physicians find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a Medscape series telling these stories.

I was coming off a 48-hour shift plus a day of doing outpatient sedation at Sparrow Hospital in Lansing. It was December and Michigan-cold. The roads were fine – no snow – but I noticed an unusual amount of traffic on the freeway. Then I saw smoke coming from an overpass up ahead.

I drove on the side of the road where I wasn’t really supposed to and got closer. An SUV had crashed into one of the big concrete structures under the bridge. I saw people running around but wasn’t able to spot EMS or any health care workers. From where I was, I could identify four kids who had already been extricated and one adult still in the driver’s seat. I estimated the kids’ ages were around 7, 5, 3, and an infant who was a few months old. I left my car and went to help.

I was able to peg the ages correctly because I’m a pediatric critical care physician. As a specialty, we’re not commonly known. We oversee patient care in intensive care units, except the patients are children. Part of the job is that we’re experts at triaging. We recognize what’s life-threatening and less so.

The kids were with some adults who kept them warm with blankets. I examined each of them. The infant was asleep but arousable and acting like a normal baby. The 3-year-old boy was vomiting and appeared very fatigued. The 5-year-old boy had a forehead laceration and was in and out of consciousness. The 7-year-old girl was screaming because of different injuries.

While all of the children were concerning to me, I identified one in particular: the 5-year-old boy. It was obvious he needed serious medical attention and fast. So, I kept that little guy in mind. The others had sustained significant injuries, but my best guess was they could get to a hospital and be stabilized.

That said, I’m a trauma instructor, and one of the things I always tell trainees is: Trauma is a black box. On the outside, it may seem like a patient doesn’t have a lot of injuries. But underneath, there might be something worse, like a brain injury. Or the chest might have taken a blunt impact affecting the heart. There may be internal bleeding somewhere in the belly. It’s really hard to tease out what exactly is going on without equipment and testing.

I didn’t even have a pulse oximeter or heart rate monitor. I pretty much just went by the appearance of the child: pulse, heart rate, awareness, things like that.

After the kids, I moved to look at the man in the car. The front end had already caught fire. I could see the driver – the kids’ father, I guessed – unconscious and hunched over. I was wondering, Why hasn’t this guy been extricated?

I approached the car on the front passenger side. And then I just had this feeling. I knew I needed to step back. Immediately.

I did. And a few seconds later, the whole car exploded in flames.

I believe God is in control of everything. I tried to get to that man. But the scene was unsafe. Later I learned that several people, including a young nurse at the scene, had tried to get to him as well.

When EMS came, I identified myself. Obviously, these people do very, very important work. But they may be more used to the 60-year-old heart attack, the 25-year-old gunshot wound, the occasional ill child. I thought that four kids – each with possible critical poly-traumatic injuries – posed a challenge to anyone.

I told them, “This is what I do on a daily basis, and this is the kid I’m worried about the most. The other kids are definitely worrisome, but I would prioritize getting this kid to the hospital first. Can I ride with you?” They agreed.

We got that boy and his older sister into the first ambulance (she was in a lot of pain, the result of a femur fracture). The two other kids rode in the second ambulance. The hospital where I had just left was 10 minutes away. I called the other pediatric critical care doctor there, my partner. He thought I was calling for a routine issue – no such luck. I said, “I’m with four kids who are level-1 traumas in two ambulances and I’m heading to the hospital right now, ETA 10 minutes.”

En route, I thought the little boy might lose consciousness at any moment. He needed a breathing tube, and I debated whether it should be done in the ambulance vs. waiting until we got to the emergency room. Based on my judgment and his vital signs, I elected to wait to have it done it in a more controlled environment. Had I felt like he was in immediate need of an airway, I would’ve attempted it. But those are the tough calls that you must make.

My partner had alerted the trauma and emergency medicine teams at the hospital. By the time we arrived, my partner was down in the ER with the trauma team and ER staff. Everyone was ready. Then it was like divide and conquer. He attended to one of the kids. The ER team and I were with the little guy I was really worried about. We had his breathing tube in within minutes. The trauma team attended to the other two.

All the kids were stabilized and then admitted to the pediatric intensive care unit. I’m happy to say that all of them did well in the end. Even the little guy I was worried about the most.

I must say this incident gave me perspective on what EMS goes through. The field medicine we do in the United States is still in its infancy in a lot of ways. One of the things I would love to see in the future is a mobile ICU. After a critical illness hits, sometimes you only have seconds, minutes, maybe hours if you’re lucky. The earlier you can get patients the treatment they need, the better the outcomes.

I like taking care of critically ill children and their families. It fits my personality. And it’s a wonderful cause. But you have to be ready for tragic cases like this one. Yes, the children came out alive, but the accident claimed a life in a horrible way. And there was nothing I could do about it.

Critical care takes an emotional, psychological, and physical toll. It’s a roller coaster: Some kids do well; some kids don’t do well. All I can do is hold myself accountable. I keep my emotions in check, whether the outcome is positive or negative. And I do my best.
 

Mohamed Hani Farhat, MD, is a pediatric critical care physician at the University of Michigan C.S. Mott Children’s Hospital in Ann Arbor and Sparrow Hospital in Lansing, Mich. Are you a physician with a dramatic medical story outside the clinic? Medscape would love to consider your story for Is There a Doctor in the House? Please email your contact information and a short summary of your story to [email protected] . A version of this article appeared on Medscape.com.

In 2002, two landmark trials found that targeted temperature management (TTM) after out-of-hospital cardiac arrest led to improvements in neurologic outcomes. The larger of the two trials found a reduction in mortality. Such treatment benefits are hard to come by in critical care in general and in out-of-hospital cardiac arrest in particular. With the therapeutic overconfidence typical of our profession, my institution embraced TTM quickly and completely soon after these trials were published. Remember, this was “back in the day” when sepsis management included drotrecogin alfa, Cortrosyn stim tests, tight glucose control (90-120 mg/dL), and horrible over-resuscitation via the early goal-directed therapy paradigm.

If you’ve been practicing critical care medicine for more than a few years, you already know where I’m going. Most of the interventions in the preceding paragraph were adopted but discarded before 2010. Though TTM has managed to stand the test of time, our confidence in its benefit has waned since 2002. Hypothermia – temperature management with a goal of 32-36° C – has been struggling to stay relevant ever since the publication of the TTM randomized controlled trial (RCT) in 2013. Then came the HYPERION trial, which brought the 32-36° C target back from the dead (pun definitely intended) in 2019. This is critical care medicine: Today’s life-saving intervention proves harmful tomorrow, but withholding it may constitute malpractice a few months down the road.

So where are we now? Good question. I’ve had seasoned neurointensivists insist that 33° C remains the standard of care and others who’ve endorsed normothermia. So much for finding an answer via my more specialized colleagues.

Let’s go to the guidelines then. Prompted largely by HYPERION, a temperature target of 32-36° C was endorsed in 2020 and 2021. Then came publication of the TTM2 trial, the largest temperature management RCT to date, which found no benefit to targeting 33° C. A network meta-analysis published in 2021 reached a similar conclusion. A recently released update by the same international guideline group now recommends targeting normothermia (< 37.7° C) and avoiding fever, and it specifically says that there is insufficient evidence to support a 32-36° C target. Okay, everyone tracking all that?

Lest I sound overly catty and nihilistic, I see all this in a positive light. Huge credit goes to the critical care medicine academic community for putting together so many RCTs. The scientific reality is that it takes “a lotta” sample size to clarify the effects of an intervention. Throw in the inevitable bevy of confounders (in- vs. out-of-hospital cardiac arrest, resuscitation time, initial rhythm, and so on), and you get a feel for the work required to understand a treatment’s true effects.

Advances in guideline science and the hard, often unpaid work of panels are also important. The guideline panel I’ve been citing came out for aggressive temperature control (32-36° C) a few months before the TTM2 RCT was published. In the past, they updated their recommendations every 5 years, but this time, they were out with a new manuscript that incorporated TTM2 in less than a year. If you’ve been involved at any level with producing guidelines, you can appreciate this achievement. Assuming that aggressive hypothermia is truly harmful, waiting 5 years to incorporate TTM2 could have led to significant morbidity.

I do take issue with you early adopters, though. Given the litany of failed therapies that have shown initial promise, and the well-documented human tendency to underestimate the impact of sample size, your rapid implementation of major interventions is puzzling. One might think you’d learned your lessons after seeing drotrecogin alfa, Cortrosyn stim tests, tight glucose control, early goal-directed therapy, and aggressive TTM come and go. Your recent enthusiasm for vitamin C after publication of a single before-after study suggests that you haven’t.

Aaron B. Holley, MD, is an associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center, Bethesda, Md. He has received a research grant from Fisher-Paykel.

A version of this article first appeared on Medscape.com.

In 2002, two landmark trials found that targeted temperature management (TTM) after out-of-hospital cardiac arrest led to improvements in neurologic outcomes. The larger of the two trials found a reduction in mortality. Such treatment benefits are hard to come by in critical care in general and in out-of-hospital cardiac arrest in particular. With the therapeutic overconfidence typical of our profession, my institution embraced TTM quickly and completely soon after these trials were published. Remember, this was “back in the day” when sepsis management included drotrecogin alfa, Cortrosyn stim tests, tight glucose control (90-120 mg/dL), and horrible over-resuscitation via the early goal-directed therapy paradigm.

If you’ve been practicing critical care medicine for more than a few years, you already know where I’m going. Most of the interventions in the preceding paragraph were adopted but discarded before 2010. Though TTM has managed to stand the test of time, our confidence in its benefit has waned since 2002. Hypothermia – temperature management with a goal of 32-36° C – has been struggling to stay relevant ever since the publication of the TTM randomized controlled trial (RCT) in 2013. Then came the HYPERION trial, which brought the 32-36° C target back from the dead (pun definitely intended) in 2019. This is critical care medicine: Today’s life-saving intervention proves harmful tomorrow, but withholding it may constitute malpractice a few months down the road.

So where are we now? Good question. I’ve had seasoned neurointensivists insist that 33° C remains the standard of care and others who’ve endorsed normothermia. So much for finding an answer via my more specialized colleagues.

Let’s go to the guidelines then. Prompted largely by HYPERION, a temperature target of 32-36° C was endorsed in 2020 and 2021. Then came publication of the TTM2 trial, the largest temperature management RCT to date, which found no benefit to targeting 33° C. A network meta-analysis published in 2021 reached a similar conclusion. A recently released update by the same international guideline group now recommends targeting normothermia (< 37.7° C) and avoiding fever, and it specifically says that there is insufficient evidence to support a 32-36° C target. Okay, everyone tracking all that?

Lest I sound overly catty and nihilistic, I see all this in a positive light. Huge credit goes to the critical care medicine academic community for putting together so many RCTs. The scientific reality is that it takes “a lotta” sample size to clarify the effects of an intervention. Throw in the inevitable bevy of confounders (in- vs. out-of-hospital cardiac arrest, resuscitation time, initial rhythm, and so on), and you get a feel for the work required to understand a treatment’s true effects.

Advances in guideline science and the hard, often unpaid work of panels are also important. The guideline panel I’ve been citing came out for aggressive temperature control (32-36° C) a few months before the TTM2 RCT was published. In the past, they updated their recommendations every 5 years, but this time, they were out with a new manuscript that incorporated TTM2 in less than a year. If you’ve been involved at any level with producing guidelines, you can appreciate this achievement. Assuming that aggressive hypothermia is truly harmful, waiting 5 years to incorporate TTM2 could have led to significant morbidity.

I do take issue with you early adopters, though. Given the litany of failed therapies that have shown initial promise, and the well-documented human tendency to underestimate the impact of sample size, your rapid implementation of major interventions is puzzling. One might think you’d learned your lessons after seeing drotrecogin alfa, Cortrosyn stim tests, tight glucose control, early goal-directed therapy, and aggressive TTM come and go. Your recent enthusiasm for vitamin C after publication of a single before-after study suggests that you haven’t.

Aaron B. Holley, MD, is an associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center, Bethesda, Md. He has received a research grant from Fisher-Paykel.

A version of this article first appeared on Medscape.com.

In 2002, two landmark trials found that targeted temperature management (TTM) after out-of-hospital cardiac arrest led to improvements in neurologic outcomes. The larger of the two trials found a reduction in mortality. Such treatment benefits are hard to come by in critical care in general and in out-of-hospital cardiac arrest in particular. With the therapeutic overconfidence typical of our profession, my institution embraced TTM quickly and completely soon after these trials were published. Remember, this was “back in the day” when sepsis management included drotrecogin alfa, Cortrosyn stim tests, tight glucose control (90-120 mg/dL), and horrible over-resuscitation via the early goal-directed therapy paradigm.

If you’ve been practicing critical care medicine for more than a few years, you already know where I’m going. Most of the interventions in the preceding paragraph were adopted but discarded before 2010. Though TTM has managed to stand the test of time, our confidence in its benefit has waned since 2002. Hypothermia – temperature management with a goal of 32-36° C – has been struggling to stay relevant ever since the publication of the TTM randomized controlled trial (RCT) in 2013. Then came the HYPERION trial, which brought the 32-36° C target back from the dead (pun definitely intended) in 2019. This is critical care medicine: Today’s life-saving intervention proves harmful tomorrow, but withholding it may constitute malpractice a few months down the road.

So where are we now? Good question. I’ve had seasoned neurointensivists insist that 33° C remains the standard of care and others who’ve endorsed normothermia. So much for finding an answer via my more specialized colleagues.

Let’s go to the guidelines then. Prompted largely by HYPERION, a temperature target of 32-36° C was endorsed in 2020 and 2021. Then came publication of the TTM2 trial, the largest temperature management RCT to date, which found no benefit to targeting 33° C. A network meta-analysis published in 2021 reached a similar conclusion. A recently released update by the same international guideline group now recommends targeting normothermia (< 37.7° C) and avoiding fever, and it specifically says that there is insufficient evidence to support a 32-36° C target. Okay, everyone tracking all that?

Lest I sound overly catty and nihilistic, I see all this in a positive light. Huge credit goes to the critical care medicine academic community for putting together so many RCTs. The scientific reality is that it takes “a lotta” sample size to clarify the effects of an intervention. Throw in the inevitable bevy of confounders (in- vs. out-of-hospital cardiac arrest, resuscitation time, initial rhythm, and so on), and you get a feel for the work required to understand a treatment’s true effects.

Advances in guideline science and the hard, often unpaid work of panels are also important. The guideline panel I’ve been citing came out for aggressive temperature control (32-36° C) a few months before the TTM2 RCT was published. In the past, they updated their recommendations every 5 years, but this time, they were out with a new manuscript that incorporated TTM2 in less than a year. If you’ve been involved at any level with producing guidelines, you can appreciate this achievement. Assuming that aggressive hypothermia is truly harmful, waiting 5 years to incorporate TTM2 could have led to significant morbidity.

I do take issue with you early adopters, though. Given the litany of failed therapies that have shown initial promise, and the well-documented human tendency to underestimate the impact of sample size, your rapid implementation of major interventions is puzzling. One might think you’d learned your lessons after seeing drotrecogin alfa, Cortrosyn stim tests, tight glucose control, early goal-directed therapy, and aggressive TTM come and go. Your recent enthusiasm for vitamin C after publication of a single before-after study suggests that you haven’t.

Aaron B. Holley, MD, is an associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center, Bethesda, Md. He has received a research grant from Fisher-Paykel.

A version of this article first appeared on Medscape.com.

After more than a week of record-breaking temperatures across much of the country, public health experts are cautioning that children are more susceptible to heat illness than adults are – even more so when they’re on the athletic field, living without air conditioning, or waiting in a parked car.

Cases of heat-related illness are rising with average air temperatures, and experts say almost half of those getting sick are children. The reason is twofold: Children’s bodies have more trouble regulating temperature than do those of adults, and they rely on adults to help protect them from overheating.

Parents, coaches, and other caretakers, who can experience the same heat very differently from the way children do, may struggle to identify a dangerous situation or catch the early symptoms of heat-related illness in children.

“Children are not little adults,” said Dr. Aaron Bernstein, a pediatric hospitalist at Boston Children’s Hospital. 

Jan Null, a meteorologist in California, recalled being surprised at the effect of heat in a car. It was 86 degrees on a July afternoon more than 2 decades ago when an infant in San Jose was forgotten in a parked car and died of heatstroke.

Mr. Null said a reporter asked him after the death, “How hot could it have gotten in that car?”

Mr. Null’s research with two emergency doctors at Stanford University eventually produced a startling answer. Within an hour, the temperature in that car could have exceeded 120 degrees Fahrenheit. Their work revealed that a quick errand can be dangerous for a child left behind in the car – even for less than 15 minutes, even with the windows cracked, and even on a mild day.

As record heat becomes more frequent, posing serious risks even to healthy adults, the number of cases of heat-related illnesses has gone up, including among children. Those most at risk are young children in parked vehicles and adolescents returning to school and participating in sports during the hottest days of the year.

More than 9,000 high school athletes are treated for heat-related illnesses every year.

Heat-related illnesses occur when exposure to high temperatures and humidity, which can be intensified by physical exertion, overwhelms the body’s ability to cool itself. Cases range from mild, like benign heat rashes in infants, to more serious, when the body’s core temperature increases. That can lead to life-threatening instances of heatstroke, diagnosed once the body temperature rises above 104 degrees, potentially causing organ failure.

Prevention is key. Experts emphasize that drinking plenty of water, avoiding the outdoors during the hot midday and afternoon hours, and taking it slow when adjusting to exercise are the most effective ways to avoid getting sick.

Children’s bodies take longer to increase sweat production and otherwise acclimatize in a warm environment than adults’ do, research shows. Young children are more susceptible to dehydration because a larger percentage of their body weight is water.

Infants and younger children have more trouble regulating their body temperature, in part because they often don’t recognize when they should drink more water or remove clothing to cool down. A 1995 study showed that young children who spent 30 minutes in a 95-degree room saw their core temperatures rise significantly higher and faster than their mothers’ – even though they sweat more than adults do relative to their size.

Pediatricians advise caretakers to monitor how much water children consume and encourage them to drink before they ask for it. Thirst indicates the body is already dehydrated.

They should dress children in light-colored, lightweight clothes; limit outdoor time during the hottest hours; and look for ways to cool down, such as by visiting an air-conditioned place like a library, taking a cool bath, or going for a swim.

To address the risks to student athletes, the National Athletic Trainers’ Association recommends that high school athletes acclimatize by gradually building their activity over the course of 2 weeks when returning to their sport for a new season – including by slowly stepping up the amount of any protective equipment they wear.

“You’re gradually increasing that intensity over a week to 2 weeks so your body can get used to the heat,” said Kathy Dieringer, president of NATA.
 

Warning signs and solutions

Experts note a flushed face, fatigue, muscle cramps, headache, dizziness, vomiting, and a lot of sweating are among the symptoms of heat exhaustion, which can develop into heatstroke if untreated. A doctor should be notified if symptoms worsen, such as if the child seems disoriented or cannot drink.

Taking immediate steps to cool a child experiencing heat exhaustion or heatstroke is critical. The child should be taken to a shaded or cool area; be given cool fluids with salt, like sports drinks; and have any sweaty or heavy garments removed.

For adolescents, being submerged in an ice bath is the most effective way to cool the body, while younger children can be wrapped in cold, wet towels or misted with lukewarm water and placed in front of a fan.

Although children’s deaths in parked cars have been well documented, the tragic incidents continue to occur. According to federal statistics, 23 children died of vehicular heatstroke in 2021. Mr. Null, who collects his own data, said 13 children have died so far this year.

Caretakers should never leave children alone in a parked car, Mr. Null said. Take steps to prevent young children from entering the car themselves and becoming trapped, including locking the car while it’s parked at home.

More than half of cases of vehicular pediatric heatstroke occur because a caretaker accidentally left a child behind, he said. While in-car technology reminding adults to check their back seats has become more common, only a fraction of vehicles have it, requiring parents to come up with their own methods, like leaving a stuffed animal in the front seat.

The good news, Mr. Null said, is that simple behavioral changes can protect youngsters. “This is preventable in 100% of the cases,” he said.
 

A lopsided risk

People living in low-income areas fare worse when temperatures climb. Access to air conditioning, which includes the ability to afford the electricity bill, is a serious health concern.

A study of heat in urban areas released last year showed that low-income neighborhoods and communities of color experience much higher temperatures than those of wealthier, White residents. In more impoverished areas during the summer, temperatures can be as much as 7 degrees Fahrenheit warmer.

The study’s authors said their findings in the United States reflect that “the legacy of redlining looms large,” referring to a federal housing policy that refused to insure mortgages in or near predominantly Black neighborhoods.

“These areas have less tree canopy, more streets, and higher building densities, meaning that in addition to their other racist outcomes, redlining policies directly codified into law existing disparity in urban land use and reinforced urban design choices that magnify urban heating into the present,” they concluded.

Dr. Bernstein, who leads Harvard’s Center for Climate, Health, and the Global Environment, coauthored a commentary in JAMA arguing that advancing health equity is critical to action on climate change.

The center works with front-line health clinics to help their predominantly low-income patients respond to the health impacts of climate change. Federally backed clinics alone provide care to about 30 million Americans, including many children, he said.

Dr. Bernstein also recently led a nationwide study that found that from May through September, days with higher temperatures are associated with more visits to children’s hospital emergency rooms. Many visits were more directly linked to heat, although the study also pointed to how high temperatures can exacerbate existing health conditions such as neurological disorders.

“Children are more vulnerable to climate change through how these climate shocks reshape the world in which they grow up,” Dr. Bernstein said.

Helping people better understand the health risks of extreme heat and how to protect themselves and their families are among the public health system’s major challenges, experts said.

The National Weather Service’s heat alert system is mainly based on the heat index, a measure of how hot it feels when relative humidity is factored in with air temperature.

But the alerts are not related to effects on health, said Kathy Baughman McLeod, director of the Adrienne Arsht-Rockefeller Foundation Resilience Center. By the time temperatures rise to the level that a weather alert is issued, many vulnerable people – like children, pregnant women, and the elderly – may already be experiencing heat exhaustion or heatstroke.

The center developed a new heat alert system, which is being tested in Seville, Spain, historically one of the hottest cities in Europe.

The system marries metrics such as air temperature and humidity with public health data to categorize heat waves and, when they are serious enough, give them names – making it easier for people to understand heat as an environmental threat that requires prevention measures.

The categories are determined through a metric known as excess deaths, which compares how many people died on a day with the forecast temperature versus an average day. That may help health officials understand how severe a heat wave is expected to be and make informed recommendations to the public based on risk factors such as age or medical history.

The health-based alert system would also allow officials to target caretakers of children and seniors through school systems, preschools, and senior centers, Ms. Baughman McLeod said.

Giving people better ways to conceptualize heat is critical, she said.

“It’s not dramatic. It doesn’t rip the roof off of your house,” Ms. Baughman McLeod said. “It’s silent and invisible.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

After more than a week of record-breaking temperatures across much of the country, public health experts are cautioning that children are more susceptible to heat illness than adults are – even more so when they’re on the athletic field, living without air conditioning, or waiting in a parked car.

Cases of heat-related illness are rising with average air temperatures, and experts say almost half of those getting sick are children. The reason is twofold: Children’s bodies have more trouble regulating temperature than do those of adults, and they rely on adults to help protect them from overheating.

Parents, coaches, and other caretakers, who can experience the same heat very differently from the way children do, may struggle to identify a dangerous situation or catch the early symptoms of heat-related illness in children.

“Children are not little adults,” said Dr. Aaron Bernstein, a pediatric hospitalist at Boston Children’s Hospital. 

Jan Null, a meteorologist in California, recalled being surprised at the effect of heat in a car. It was 86 degrees on a July afternoon more than 2 decades ago when an infant in San Jose was forgotten in a parked car and died of heatstroke.

Mr. Null said a reporter asked him after the death, “How hot could it have gotten in that car?”

Mr. Null’s research with two emergency doctors at Stanford University eventually produced a startling answer. Within an hour, the temperature in that car could have exceeded 120 degrees Fahrenheit. Their work revealed that a quick errand can be dangerous for a child left behind in the car – even for less than 15 minutes, even with the windows cracked, and even on a mild day.

As record heat becomes more frequent, posing serious risks even to healthy adults, the number of cases of heat-related illnesses has gone up, including among children. Those most at risk are young children in parked vehicles and adolescents returning to school and participating in sports during the hottest days of the year.

More than 9,000 high school athletes are treated for heat-related illnesses every year.

Heat-related illnesses occur when exposure to high temperatures and humidity, which can be intensified by physical exertion, overwhelms the body’s ability to cool itself. Cases range from mild, like benign heat rashes in infants, to more serious, when the body’s core temperature increases. That can lead to life-threatening instances of heatstroke, diagnosed once the body temperature rises above 104 degrees, potentially causing organ failure.

Prevention is key. Experts emphasize that drinking plenty of water, avoiding the outdoors during the hot midday and afternoon hours, and taking it slow when adjusting to exercise are the most effective ways to avoid getting sick.

Children’s bodies take longer to increase sweat production and otherwise acclimatize in a warm environment than adults’ do, research shows. Young children are more susceptible to dehydration because a larger percentage of their body weight is water.

Infants and younger children have more trouble regulating their body temperature, in part because they often don’t recognize when they should drink more water or remove clothing to cool down. A 1995 study showed that young children who spent 30 minutes in a 95-degree room saw their core temperatures rise significantly higher and faster than their mothers’ – even though they sweat more than adults do relative to their size.

Pediatricians advise caretakers to monitor how much water children consume and encourage them to drink before they ask for it. Thirst indicates the body is already dehydrated.

They should dress children in light-colored, lightweight clothes; limit outdoor time during the hottest hours; and look for ways to cool down, such as by visiting an air-conditioned place like a library, taking a cool bath, or going for a swim.

To address the risks to student athletes, the National Athletic Trainers’ Association recommends that high school athletes acclimatize by gradually building their activity over the course of 2 weeks when returning to their sport for a new season – including by slowly stepping up the amount of any protective equipment they wear.

“You’re gradually increasing that intensity over a week to 2 weeks so your body can get used to the heat,” said Kathy Dieringer, president of NATA.
 

Warning signs and solutions

Experts note a flushed face, fatigue, muscle cramps, headache, dizziness, vomiting, and a lot of sweating are among the symptoms of heat exhaustion, which can develop into heatstroke if untreated. A doctor should be notified if symptoms worsen, such as if the child seems disoriented or cannot drink.

Taking immediate steps to cool a child experiencing heat exhaustion or heatstroke is critical. The child should be taken to a shaded or cool area; be given cool fluids with salt, like sports drinks; and have any sweaty or heavy garments removed.

For adolescents, being submerged in an ice bath is the most effective way to cool the body, while younger children can be wrapped in cold, wet towels or misted with lukewarm water and placed in front of a fan.

Although children’s deaths in parked cars have been well documented, the tragic incidents continue to occur. According to federal statistics, 23 children died of vehicular heatstroke in 2021. Mr. Null, who collects his own data, said 13 children have died so far this year.

Caretakers should never leave children alone in a parked car, Mr. Null said. Take steps to prevent young children from entering the car themselves and becoming trapped, including locking the car while it’s parked at home.

More than half of cases of vehicular pediatric heatstroke occur because a caretaker accidentally left a child behind, he said. While in-car technology reminding adults to check their back seats has become more common, only a fraction of vehicles have it, requiring parents to come up with their own methods, like leaving a stuffed animal in the front seat.

The good news, Mr. Null said, is that simple behavioral changes can protect youngsters. “This is preventable in 100% of the cases,” he said.
 

A lopsided risk

People living in low-income areas fare worse when temperatures climb. Access to air conditioning, which includes the ability to afford the electricity bill, is a serious health concern.

A study of heat in urban areas released last year showed that low-income neighborhoods and communities of color experience much higher temperatures than those of wealthier, White residents. In more impoverished areas during the summer, temperatures can be as much as 7 degrees Fahrenheit warmer.

The study’s authors said their findings in the United States reflect that “the legacy of redlining looms large,” referring to a federal housing policy that refused to insure mortgages in or near predominantly Black neighborhoods.

“These areas have less tree canopy, more streets, and higher building densities, meaning that in addition to their other racist outcomes, redlining policies directly codified into law existing disparity in urban land use and reinforced urban design choices that magnify urban heating into the present,” they concluded.

Dr. Bernstein, who leads Harvard’s Center for Climate, Health, and the Global Environment, coauthored a commentary in JAMA arguing that advancing health equity is critical to action on climate change.

The center works with front-line health clinics to help their predominantly low-income patients respond to the health impacts of climate change. Federally backed clinics alone provide care to about 30 million Americans, including many children, he said.

Dr. Bernstein also recently led a nationwide study that found that from May through September, days with higher temperatures are associated with more visits to children’s hospital emergency rooms. Many visits were more directly linked to heat, although the study also pointed to how high temperatures can exacerbate existing health conditions such as neurological disorders.

“Children are more vulnerable to climate change through how these climate shocks reshape the world in which they grow up,” Dr. Bernstein said.

Helping people better understand the health risks of extreme heat and how to protect themselves and their families are among the public health system’s major challenges, experts said.

The National Weather Service’s heat alert system is mainly based on the heat index, a measure of how hot it feels when relative humidity is factored in with air temperature.

But the alerts are not related to effects on health, said Kathy Baughman McLeod, director of the Adrienne Arsht-Rockefeller Foundation Resilience Center. By the time temperatures rise to the level that a weather alert is issued, many vulnerable people – like children, pregnant women, and the elderly – may already be experiencing heat exhaustion or heatstroke.

The center developed a new heat alert system, which is being tested in Seville, Spain, historically one of the hottest cities in Europe.

The system marries metrics such as air temperature and humidity with public health data to categorize heat waves and, when they are serious enough, give them names – making it easier for people to understand heat as an environmental threat that requires prevention measures.

The categories are determined through a metric known as excess deaths, which compares how many people died on a day with the forecast temperature versus an average day. That may help health officials understand how severe a heat wave is expected to be and make informed recommendations to the public based on risk factors such as age or medical history.

The health-based alert system would also allow officials to target caretakers of children and seniors through school systems, preschools, and senior centers, Ms. Baughman McLeod said.

Giving people better ways to conceptualize heat is critical, she said.

“It’s not dramatic. It doesn’t rip the roof off of your house,” Ms. Baughman McLeod said. “It’s silent and invisible.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

After more than a week of record-breaking temperatures across much of the country, public health experts are cautioning that children are more susceptible to heat illness than adults are – even more so when they’re on the athletic field, living without air conditioning, or waiting in a parked car.

Cases of heat-related illness are rising with average air temperatures, and experts say almost half of those getting sick are children. The reason is twofold: Children’s bodies have more trouble regulating temperature than do those of adults, and they rely on adults to help protect them from overheating.

Parents, coaches, and other caretakers, who can experience the same heat very differently from the way children do, may struggle to identify a dangerous situation or catch the early symptoms of heat-related illness in children.

“Children are not little adults,” said Dr. Aaron Bernstein, a pediatric hospitalist at Boston Children’s Hospital. 

Jan Null, a meteorologist in California, recalled being surprised at the effect of heat in a car. It was 86 degrees on a July afternoon more than 2 decades ago when an infant in San Jose was forgotten in a parked car and died of heatstroke.

Mr. Null said a reporter asked him after the death, “How hot could it have gotten in that car?”

Mr. Null’s research with two emergency doctors at Stanford University eventually produced a startling answer. Within an hour, the temperature in that car could have exceeded 120 degrees Fahrenheit. Their work revealed that a quick errand can be dangerous for a child left behind in the car – even for less than 15 minutes, even with the windows cracked, and even on a mild day.

As record heat becomes more frequent, posing serious risks even to healthy adults, the number of cases of heat-related illnesses has gone up, including among children. Those most at risk are young children in parked vehicles and adolescents returning to school and participating in sports during the hottest days of the year.

More than 9,000 high school athletes are treated for heat-related illnesses every year.

Heat-related illnesses occur when exposure to high temperatures and humidity, which can be intensified by physical exertion, overwhelms the body’s ability to cool itself. Cases range from mild, like benign heat rashes in infants, to more serious, when the body’s core temperature increases. That can lead to life-threatening instances of heatstroke, diagnosed once the body temperature rises above 104 degrees, potentially causing organ failure.

Prevention is key. Experts emphasize that drinking plenty of water, avoiding the outdoors during the hot midday and afternoon hours, and taking it slow when adjusting to exercise are the most effective ways to avoid getting sick.

Children’s bodies take longer to increase sweat production and otherwise acclimatize in a warm environment than adults’ do, research shows. Young children are more susceptible to dehydration because a larger percentage of their body weight is water.

Infants and younger children have more trouble regulating their body temperature, in part because they often don’t recognize when they should drink more water or remove clothing to cool down. A 1995 study showed that young children who spent 30 minutes in a 95-degree room saw their core temperatures rise significantly higher and faster than their mothers’ – even though they sweat more than adults do relative to their size.

Pediatricians advise caretakers to monitor how much water children consume and encourage them to drink before they ask for it. Thirst indicates the body is already dehydrated.

They should dress children in light-colored, lightweight clothes; limit outdoor time during the hottest hours; and look for ways to cool down, such as by visiting an air-conditioned place like a library, taking a cool bath, or going for a swim.

To address the risks to student athletes, the National Athletic Trainers’ Association recommends that high school athletes acclimatize by gradually building their activity over the course of 2 weeks when returning to their sport for a new season – including by slowly stepping up the amount of any protective equipment they wear.

“You’re gradually increasing that intensity over a week to 2 weeks so your body can get used to the heat,” said Kathy Dieringer, president of NATA.
 

Warning signs and solutions

Experts note a flushed face, fatigue, muscle cramps, headache, dizziness, vomiting, and a lot of sweating are among the symptoms of heat exhaustion, which can develop into heatstroke if untreated. A doctor should be notified if symptoms worsen, such as if the child seems disoriented or cannot drink.

Taking immediate steps to cool a child experiencing heat exhaustion or heatstroke is critical. The child should be taken to a shaded or cool area; be given cool fluids with salt, like sports drinks; and have any sweaty or heavy garments removed.

For adolescents, being submerged in an ice bath is the most effective way to cool the body, while younger children can be wrapped in cold, wet towels or misted with lukewarm water and placed in front of a fan.

Although children’s deaths in parked cars have been well documented, the tragic incidents continue to occur. According to federal statistics, 23 children died of vehicular heatstroke in 2021. Mr. Null, who collects his own data, said 13 children have died so far this year.

Caretakers should never leave children alone in a parked car, Mr. Null said. Take steps to prevent young children from entering the car themselves and becoming trapped, including locking the car while it’s parked at home.

More than half of cases of vehicular pediatric heatstroke occur because a caretaker accidentally left a child behind, he said. While in-car technology reminding adults to check their back seats has become more common, only a fraction of vehicles have it, requiring parents to come up with their own methods, like leaving a stuffed animal in the front seat.

The good news, Mr. Null said, is that simple behavioral changes can protect youngsters. “This is preventable in 100% of the cases,” he said.
 

A lopsided risk

People living in low-income areas fare worse when temperatures climb. Access to air conditioning, which includes the ability to afford the electricity bill, is a serious health concern.

A study of heat in urban areas released last year showed that low-income neighborhoods and communities of color experience much higher temperatures than those of wealthier, White residents. In more impoverished areas during the summer, temperatures can be as much as 7 degrees Fahrenheit warmer.

The study’s authors said their findings in the United States reflect that “the legacy of redlining looms large,” referring to a federal housing policy that refused to insure mortgages in or near predominantly Black neighborhoods.

“These areas have less tree canopy, more streets, and higher building densities, meaning that in addition to their other racist outcomes, redlining policies directly codified into law existing disparity in urban land use and reinforced urban design choices that magnify urban heating into the present,” they concluded.

Dr. Bernstein, who leads Harvard’s Center for Climate, Health, and the Global Environment, coauthored a commentary in JAMA arguing that advancing health equity is critical to action on climate change.

The center works with front-line health clinics to help their predominantly low-income patients respond to the health impacts of climate change. Federally backed clinics alone provide care to about 30 million Americans, including many children, he said.

Dr. Bernstein also recently led a nationwide study that found that from May through September, days with higher temperatures are associated with more visits to children’s hospital emergency rooms. Many visits were more directly linked to heat, although the study also pointed to how high temperatures can exacerbate existing health conditions such as neurological disorders.

“Children are more vulnerable to climate change through how these climate shocks reshape the world in which they grow up,” Dr. Bernstein said.

Helping people better understand the health risks of extreme heat and how to protect themselves and their families are among the public health system’s major challenges, experts said.

The National Weather Service’s heat alert system is mainly based on the heat index, a measure of how hot it feels when relative humidity is factored in with air temperature.

But the alerts are not related to effects on health, said Kathy Baughman McLeod, director of the Adrienne Arsht-Rockefeller Foundation Resilience Center. By the time temperatures rise to the level that a weather alert is issued, many vulnerable people – like children, pregnant women, and the elderly – may already be experiencing heat exhaustion or heatstroke.

The center developed a new heat alert system, which is being tested in Seville, Spain, historically one of the hottest cities in Europe.

The system marries metrics such as air temperature and humidity with public health data to categorize heat waves and, when they are serious enough, give them names – making it easier for people to understand heat as an environmental threat that requires prevention measures.

The categories are determined through a metric known as excess deaths, which compares how many people died on a day with the forecast temperature versus an average day. That may help health officials understand how severe a heat wave is expected to be and make informed recommendations to the public based on risk factors such as age or medical history.

The health-based alert system would also allow officials to target caretakers of children and seniors through school systems, preschools, and senior centers, Ms. Baughman McLeod said.

Giving people better ways to conceptualize heat is critical, she said.

“It’s not dramatic. It doesn’t rip the roof off of your house,” Ms. Baughman McLeod said. “It’s silent and invisible.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Severe airway injuries are a “not infrequent” consequence after children swallow button batteries, which are commonly found in many household electronics, according to a systematic review published online in JAMA Otolaryngology–Head & Neck Surgery.

Most literature has focused on esophageal injury, but “the direct apposition of the esophagus to the trachea and recurrent laryngeal nerves also places these children at risk of airway injury, such as tracheoesophageal fistula (TEF) (a life-threatening complication), vocal cord paresis and paralysis, tracheal stenosis, and tracheomalacia,” the researchers wrote.

Led by Justine Philteos, MD, of the department of otolaryngology–head and neck surgery at the University of Toronto, the researchers found that tracheoesophageal fistula and vocal cord paralyses were the two most common airway injuries and often required tracheostomy.

The review included 195 children pulled from the National Capital Poison Center (NCPC) database – more often young children – who had ingested the batteries. The average age at ingestion was 17.8 months and the average time between ingestion and removal was 5.8 days.

Of the 195 children, 29 (15%) underwent tracheostomy, and 11 of the 29 children (38%) ultimately had decannulation. There were 14 deaths from swallowing the batteries. All 14 patients had a TEF. The cause of death was identified for 12 of the patients: Four died of pneumonia or respiratory failure; three of massive hematemesis; three of sepsis; one of multiorgan failure, and one of anoxic encephalopathy.

Vocal cord injury occurred after a shorter button battery exposure than other airway injuries.

The authors concluded that prioritizing quick button battery removal is essential “to decrease the devastating consequences of these injuries.”

In an invited commentary, Hannah Gibbs, and Kris R. Jatana, MD, of The Ohio State University in Columbus, described what’s being done to prevent and treat these injuries and what’s next.

They noted that ingestion is often unseen so diagnosis is difficult. Therefore, they wrote, a novel coin-battery metal detector could be a radiation-free, quick screening tool. They noted a patent-pending technology has been developed at Ohio State and Nationwide Children’s Hospital.

Honey can help slow injury

Some measures can be taken at home or in the hospital if battery swallowing is discovered, the editorialists noted.

In the home or in transport to the hospital, caregivers can give 10 mL of honey every 10 minutes until arrival if the child is older than 12 months.

At the hospital, 10 mL of either honey or sucralfate may be given every 10 minutes to slow the rate of injury until the battery can be surgically removed.

“The current NCPC guidelines suggest up to six doses may be given in the prehospital setting, with three additional doses administered in the hospital,” they wrote.

“These strategies should be considered earlier than 12 hours from ingestion, when there is no clinical concern for mediastinitis or sepsis. A child with an esophageal button battery should proceed to the operating room immediately regardless of whether he or she has recently eaten,” Ms. Gibbs and Dr. Jatana wrote.
 

App adds convenience to boost physician reporting

Foreign body ingestions are also severely underreported, they noted. They cited a survey of more than 400 physicians who directly manage foreign body ingestions that found only 11% of button battery injuries and 4% of all foreign body ingestion or aspiration events were reported. The great majority (92%) of respondents said they would report the events if that were more convenient.

To that end, the Global Injury Research Collaborative (GIRC) has created and released a free smartphone application, the GIRC App. It is available free on the iOS system (through App Store) and soon will be available on the Android system (through Google Play), they wrote.

Ms. Gibbs and Dr. Jatana urge other measures, including safer battery compartments and battery design, to reduce the likelihood of ingestion.

They pointed out that a bill was introduced in Congress that would require the Consumer Product Safety Commission to mandate a new standard for child-resistant compartments on products containing button batteries. The act, called Reese’s Law, has been referred to the Committee on Energy and Commerce and is under review.

Dr. Jatana reported having a patent pending for a coin or battery metal detector device under development; being a shareholder in Zotarix, Landsdowne Labs, and Tivic Health Systems; serving in a leadership position on the National Button Battery Task Force; and being a board member of the Global Injury Research Collaborative, which is a U.S. Internal Revenue Service–designated, 501(c)(3) nonprofit research organization. No other relevant disclosures were reported.

Severe airway injuries are a “not infrequent” consequence after children swallow button batteries, which are commonly found in many household electronics, according to a systematic review published online in JAMA Otolaryngology–Head & Neck Surgery.

Most literature has focused on esophageal injury, but “the direct apposition of the esophagus to the trachea and recurrent laryngeal nerves also places these children at risk of airway injury, such as tracheoesophageal fistula (TEF) (a life-threatening complication), vocal cord paresis and paralysis, tracheal stenosis, and tracheomalacia,” the researchers wrote.

Led by Justine Philteos, MD, of the department of otolaryngology–head and neck surgery at the University of Toronto, the researchers found that tracheoesophageal fistula and vocal cord paralyses were the two most common airway injuries and often required tracheostomy.

The review included 195 children pulled from the National Capital Poison Center (NCPC) database – more often young children – who had ingested the batteries. The average age at ingestion was 17.8 months and the average time between ingestion and removal was 5.8 days.

Of the 195 children, 29 (15%) underwent tracheostomy, and 11 of the 29 children (38%) ultimately had decannulation. There were 14 deaths from swallowing the batteries. All 14 patients had a TEF. The cause of death was identified for 12 of the patients: Four died of pneumonia or respiratory failure; three of massive hematemesis; three of sepsis; one of multiorgan failure, and one of anoxic encephalopathy.

Vocal cord injury occurred after a shorter button battery exposure than other airway injuries.

The authors concluded that prioritizing quick button battery removal is essential “to decrease the devastating consequences of these injuries.”

In an invited commentary, Hannah Gibbs, and Kris R. Jatana, MD, of The Ohio State University in Columbus, described what’s being done to prevent and treat these injuries and what’s next.

They noted that ingestion is often unseen so diagnosis is difficult. Therefore, they wrote, a novel coin-battery metal detector could be a radiation-free, quick screening tool. They noted a patent-pending technology has been developed at Ohio State and Nationwide Children’s Hospital.

Honey can help slow injury

Some measures can be taken at home or in the hospital if battery swallowing is discovered, the editorialists noted.

In the home or in transport to the hospital, caregivers can give 10 mL of honey every 10 minutes until arrival if the child is older than 12 months.

At the hospital, 10 mL of either honey or sucralfate may be given every 10 minutes to slow the rate of injury until the battery can be surgically removed.

“The current NCPC guidelines suggest up to six doses may be given in the prehospital setting, with three additional doses administered in the hospital,” they wrote.

“These strategies should be considered earlier than 12 hours from ingestion, when there is no clinical concern for mediastinitis or sepsis. A child with an esophageal button battery should proceed to the operating room immediately regardless of whether he or she has recently eaten,” Ms. Gibbs and Dr. Jatana wrote.
 

App adds convenience to boost physician reporting

Foreign body ingestions are also severely underreported, they noted. They cited a survey of more than 400 physicians who directly manage foreign body ingestions that found only 11% of button battery injuries and 4% of all foreign body ingestion or aspiration events were reported. The great majority (92%) of respondents said they would report the events if that were more convenient.

To that end, the Global Injury Research Collaborative (GIRC) has created and released a free smartphone application, the GIRC App. It is available free on the iOS system (through App Store) and soon will be available on the Android system (through Google Play), they wrote.

Ms. Gibbs and Dr. Jatana urge other measures, including safer battery compartments and battery design, to reduce the likelihood of ingestion.

They pointed out that a bill was introduced in Congress that would require the Consumer Product Safety Commission to mandate a new standard for child-resistant compartments on products containing button batteries. The act, called Reese’s Law, has been referred to the Committee on Energy and Commerce and is under review.

Dr. Jatana reported having a patent pending for a coin or battery metal detector device under development; being a shareholder in Zotarix, Landsdowne Labs, and Tivic Health Systems; serving in a leadership position on the National Button Battery Task Force; and being a board member of the Global Injury Research Collaborative, which is a U.S. Internal Revenue Service–designated, 501(c)(3) nonprofit research organization. No other relevant disclosures were reported.

Severe airway injuries are a “not infrequent” consequence after children swallow button batteries, which are commonly found in many household electronics, according to a systematic review published online in JAMA Otolaryngology–Head & Neck Surgery.

Most literature has focused on esophageal injury, but “the direct apposition of the esophagus to the trachea and recurrent laryngeal nerves also places these children at risk of airway injury, such as tracheoesophageal fistula (TEF) (a life-threatening complication), vocal cord paresis and paralysis, tracheal stenosis, and tracheomalacia,” the researchers wrote.

Led by Justine Philteos, MD, of the department of otolaryngology–head and neck surgery at the University of Toronto, the researchers found that tracheoesophageal fistula and vocal cord paralyses were the two most common airway injuries and often required tracheostomy.

The review included 195 children pulled from the National Capital Poison Center (NCPC) database – more often young children – who had ingested the batteries. The average age at ingestion was 17.8 months and the average time between ingestion and removal was 5.8 days.

Of the 195 children, 29 (15%) underwent tracheostomy, and 11 of the 29 children (38%) ultimately had decannulation. There were 14 deaths from swallowing the batteries. All 14 patients had a TEF. The cause of death was identified for 12 of the patients: Four died of pneumonia or respiratory failure; three of massive hematemesis; three of sepsis; one of multiorgan failure, and one of anoxic encephalopathy.

Vocal cord injury occurred after a shorter button battery exposure than other airway injuries.

The authors concluded that prioritizing quick button battery removal is essential “to decrease the devastating consequences of these injuries.”

In an invited commentary, Hannah Gibbs, and Kris R. Jatana, MD, of The Ohio State University in Columbus, described what’s being done to prevent and treat these injuries and what’s next.

They noted that ingestion is often unseen so diagnosis is difficult. Therefore, they wrote, a novel coin-battery metal detector could be a radiation-free, quick screening tool. They noted a patent-pending technology has been developed at Ohio State and Nationwide Children’s Hospital.

Honey can help slow injury

Some measures can be taken at home or in the hospital if battery swallowing is discovered, the editorialists noted.

In the home or in transport to the hospital, caregivers can give 10 mL of honey every 10 minutes until arrival if the child is older than 12 months.

At the hospital, 10 mL of either honey or sucralfate may be given every 10 minutes to slow the rate of injury until the battery can be surgically removed.

“The current NCPC guidelines suggest up to six doses may be given in the prehospital setting, with three additional doses administered in the hospital,” they wrote.

“These strategies should be considered earlier than 12 hours from ingestion, when there is no clinical concern for mediastinitis or sepsis. A child with an esophageal button battery should proceed to the operating room immediately regardless of whether he or she has recently eaten,” Ms. Gibbs and Dr. Jatana wrote.
 

App adds convenience to boost physician reporting

Foreign body ingestions are also severely underreported, they noted. They cited a survey of more than 400 physicians who directly manage foreign body ingestions that found only 11% of button battery injuries and 4% of all foreign body ingestion or aspiration events were reported. The great majority (92%) of respondents said they would report the events if that were more convenient.

To that end, the Global Injury Research Collaborative (GIRC) has created and released a free smartphone application, the GIRC App. It is available free on the iOS system (through App Store) and soon will be available on the Android system (through Google Play), they wrote.

Ms. Gibbs and Dr. Jatana urge other measures, including safer battery compartments and battery design, to reduce the likelihood of ingestion.

They pointed out that a bill was introduced in Congress that would require the Consumer Product Safety Commission to mandate a new standard for child-resistant compartments on products containing button batteries. The act, called Reese’s Law, has been referred to the Committee on Energy and Commerce and is under review.

Dr. Jatana reported having a patent pending for a coin or battery metal detector device under development; being a shareholder in Zotarix, Landsdowne Labs, and Tivic Health Systems; serving in a leadership position on the National Button Battery Task Force; and being a board member of the Global Injury Research Collaborative, which is a U.S. Internal Revenue Service–designated, 501(c)(3) nonprofit research organization. No other relevant disclosures were reported.

Having a mobile interventional stroke team (MIST) travel to treat stroke patients soon after stroke onset may improve patient outcomes, according to a new study. A retrospective analysis of a pilot program in New York found that patients who were treated on the ground by the MIST team rather than transferred to a specialized stroke center received faster care and were almost twice as likely to be functionally independent 3 months later.

“The use of a Mobile Interventional Stroke Team (MIST) traveling to Thrombectomy Capable Stroke Centers to perform endovascular thrombectomy has been shown to be significantly faster with improved discharge outcomes,” wrote lead author Jacob Morey, a doctoral Candidate at Icahn School of Medicine at Mount Sinai in New York and coauthors in the paper. Prior to this study, “the effect of the MIST model stratified by time of presentation” had yet to be studied.

The findings were published online on Aug. 5 in Stroke.
 

MIST model versus drip-and-ship

The researchers analyzed 226 patients who underwent endovascular thrombectomy between January 2017 and February 2020 at four hospitals in the Mount Sinai health system using the NYC MIST Trial and a stroke database. At baseline, all patients were functionally independent as assessed by the modified Rankin Scale (mRS, score of 0-2). 106 patients were treated by a MIST team – staffed by a neurointerventionalist, a fellow or physician assistant, and radiologic technologist – that traveled to the patient’s location. A total of 120 patients were transferred to a comprehensive stroke center (CSC) or a hospital with endovascular thrombectomy expertise. The analysis was stratified based on whether the patient presented in the early time window (≤ 6 hours) or late time window (> 6 hours).

Patients treated in the early time window were significantly more likely to be mobile and able to perform daily tasks (mRS ≤ 2) 90 days after the procedure in the MIST group (54%), compared with the transferred group (28%, P < 0.01). Outcomes did not differ significantly between groups in the late time window (35% vs. 41%, P = 0.77).

Similarly, early-time-window patients in the MIST group were more likely to have higher functionality at discharge, compared with transferred patients, based on the on the National Institutes of Health Stroke Scale (median score of 5.0 vs. 12.0, P < 0.01). There was no significant difference between groups treated in the late time window (median score of 5.0 vs. 11.0, P = 0.11).

“Ischemic strokes often progress rapidly and can cause severe damage because brain tissue dies quickly without oxygen, resulting in serious long-term disabilities or death,“ said Johanna Fifi, MD, of Icahn School of Medicine, said in a statement to the American Heart Association. “Assessing and treating stroke patients in the early window means that a greater number of fast-progressing strokes are identified and treated.”

Time is brain

Endovascular thrombectomy is a time-sensitive surgical procedure to remove large blood clots in acute ischemic stroke that has “historically been limited to comprehensive stroke centers,” the authors wrote in their paper. It is considered the standard of care in ischemic strokes, which make up 90% of all strokes. “Less than 50% of Americans have direct access to endovascular thrombectomy, the others must be transferred to a thrombectomy-capable hospital for treatment, often losing over 2 hours of time to treatment,” said Dr. Fifi. “Every minute is precious in treating stroke, and getting to a center that offers thrombectomy is very important. The MIST model would address this by providing faster access to this potentially life-saving, disability-reducing procedure.”

Access to timely endovascular thrombectomy is gradually improving as “more institutions and cities have implemented the [MIST] model.” Dr. Fifi said.

“This study stresses the importance of ‘time is brain,’ especially for patients in the early time window. Although the study is limited by the observational, retrospective design and was performed at a single integrated center, the findings are provocative,” said Louise McCullough, MD, of the University of Texas Health Science Center at Houston said in a statement to the American Heart Association. “The use of a MIST model highlights the potential benefit of early and urgent treatment for patients with large-vessel stroke. Stroke systems of care need to take advantage of any opportunity to treat patients early, wherever they are.”

The study was partly funded by a Stryker Foundation grant.

Having a mobile interventional stroke team (MIST) travel to treat stroke patients soon after stroke onset may improve patient outcomes, according to a new study. A retrospective analysis of a pilot program in New York found that patients who were treated on the ground by the MIST team rather than transferred to a specialized stroke center received faster care and were almost twice as likely to be functionally independent 3 months later.

“The use of a Mobile Interventional Stroke Team (MIST) traveling to Thrombectomy Capable Stroke Centers to perform endovascular thrombectomy has been shown to be significantly faster with improved discharge outcomes,” wrote lead author Jacob Morey, a doctoral Candidate at Icahn School of Medicine at Mount Sinai in New York and coauthors in the paper. Prior to this study, “the effect of the MIST model stratified by time of presentation” had yet to be studied.

The findings were published online on Aug. 5 in Stroke.
 

MIST model versus drip-and-ship

The researchers analyzed 226 patients who underwent endovascular thrombectomy between January 2017 and February 2020 at four hospitals in the Mount Sinai health system using the NYC MIST Trial and a stroke database. At baseline, all patients were functionally independent as assessed by the modified Rankin Scale (mRS, score of 0-2). 106 patients were treated by a MIST team – staffed by a neurointerventionalist, a fellow or physician assistant, and radiologic technologist – that traveled to the patient’s location. A total of 120 patients were transferred to a comprehensive stroke center (CSC) or a hospital with endovascular thrombectomy expertise. The analysis was stratified based on whether the patient presented in the early time window (≤ 6 hours) or late time window (> 6 hours).

Patients treated in the early time window were significantly more likely to be mobile and able to perform daily tasks (mRS ≤ 2) 90 days after the procedure in the MIST group (54%), compared with the transferred group (28%, P < 0.01). Outcomes did not differ significantly between groups in the late time window (35% vs. 41%, P = 0.77).

Similarly, early-time-window patients in the MIST group were more likely to have higher functionality at discharge, compared with transferred patients, based on the on the National Institutes of Health Stroke Scale (median score of 5.0 vs. 12.0, P < 0.01). There was no significant difference between groups treated in the late time window (median score of 5.0 vs. 11.0, P = 0.11).

“Ischemic strokes often progress rapidly and can cause severe damage because brain tissue dies quickly without oxygen, resulting in serious long-term disabilities or death,“ said Johanna Fifi, MD, of Icahn School of Medicine, said in a statement to the American Heart Association. “Assessing and treating stroke patients in the early window means that a greater number of fast-progressing strokes are identified and treated.”

Time is brain

Endovascular thrombectomy is a time-sensitive surgical procedure to remove large blood clots in acute ischemic stroke that has “historically been limited to comprehensive stroke centers,” the authors wrote in their paper. It is considered the standard of care in ischemic strokes, which make up 90% of all strokes. “Less than 50% of Americans have direct access to endovascular thrombectomy, the others must be transferred to a thrombectomy-capable hospital for treatment, often losing over 2 hours of time to treatment,” said Dr. Fifi. “Every minute is precious in treating stroke, and getting to a center that offers thrombectomy is very important. The MIST model would address this by providing faster access to this potentially life-saving, disability-reducing procedure.”

Access to timely endovascular thrombectomy is gradually improving as “more institutions and cities have implemented the [MIST] model.” Dr. Fifi said.

“This study stresses the importance of ‘time is brain,’ especially for patients in the early time window. Although the study is limited by the observational, retrospective design and was performed at a single integrated center, the findings are provocative,” said Louise McCullough, MD, of the University of Texas Health Science Center at Houston said in a statement to the American Heart Association. “The use of a MIST model highlights the potential benefit of early and urgent treatment for patients with large-vessel stroke. Stroke systems of care need to take advantage of any opportunity to treat patients early, wherever they are.”

The study was partly funded by a Stryker Foundation grant.

Having a mobile interventional stroke team (MIST) travel to treat stroke patients soon after stroke onset may improve patient outcomes, according to a new study. A retrospective analysis of a pilot program in New York found that patients who were treated on the ground by the MIST team rather than transferred to a specialized stroke center received faster care and were almost twice as likely to be functionally independent 3 months later.

“The use of a Mobile Interventional Stroke Team (MIST) traveling to Thrombectomy Capable Stroke Centers to perform endovascular thrombectomy has been shown to be significantly faster with improved discharge outcomes,” wrote lead author Jacob Morey, a doctoral Candidate at Icahn School of Medicine at Mount Sinai in New York and coauthors in the paper. Prior to this study, “the effect of the MIST model stratified by time of presentation” had yet to be studied.

The findings were published online on Aug. 5 in Stroke.
 

MIST model versus drip-and-ship

The researchers analyzed 226 patients who underwent endovascular thrombectomy between January 2017 and February 2020 at four hospitals in the Mount Sinai health system using the NYC MIST Trial and a stroke database. At baseline, all patients were functionally independent as assessed by the modified Rankin Scale (mRS, score of 0-2). 106 patients were treated by a MIST team – staffed by a neurointerventionalist, a fellow or physician assistant, and radiologic technologist – that traveled to the patient’s location. A total of 120 patients were transferred to a comprehensive stroke center (CSC) or a hospital with endovascular thrombectomy expertise. The analysis was stratified based on whether the patient presented in the early time window (≤ 6 hours) or late time window (> 6 hours).

Patients treated in the early time window were significantly more likely to be mobile and able to perform daily tasks (mRS ≤ 2) 90 days after the procedure in the MIST group (54%), compared with the transferred group (28%, P < 0.01). Outcomes did not differ significantly between groups in the late time window (35% vs. 41%, P = 0.77).

Similarly, early-time-window patients in the MIST group were more likely to have higher functionality at discharge, compared with transferred patients, based on the on the National Institutes of Health Stroke Scale (median score of 5.0 vs. 12.0, P < 0.01). There was no significant difference between groups treated in the late time window (median score of 5.0 vs. 11.0, P = 0.11).

“Ischemic strokes often progress rapidly and can cause severe damage because brain tissue dies quickly without oxygen, resulting in serious long-term disabilities or death,“ said Johanna Fifi, MD, of Icahn School of Medicine, said in a statement to the American Heart Association. “Assessing and treating stroke patients in the early window means that a greater number of fast-progressing strokes are identified and treated.”

Time is brain

Endovascular thrombectomy is a time-sensitive surgical procedure to remove large blood clots in acute ischemic stroke that has “historically been limited to comprehensive stroke centers,” the authors wrote in their paper. It is considered the standard of care in ischemic strokes, which make up 90% of all strokes. “Less than 50% of Americans have direct access to endovascular thrombectomy, the others must be transferred to a thrombectomy-capable hospital for treatment, often losing over 2 hours of time to treatment,” said Dr. Fifi. “Every minute is precious in treating stroke, and getting to a center that offers thrombectomy is very important. The MIST model would address this by providing faster access to this potentially life-saving, disability-reducing procedure.”

Access to timely endovascular thrombectomy is gradually improving as “more institutions and cities have implemented the [MIST] model.” Dr. Fifi said.

“This study stresses the importance of ‘time is brain,’ especially for patients in the early time window. Although the study is limited by the observational, retrospective design and was performed at a single integrated center, the findings are provocative,” said Louise McCullough, MD, of the University of Texas Health Science Center at Houston said in a statement to the American Heart Association. “The use of a MIST model highlights the potential benefit of early and urgent treatment for patients with large-vessel stroke. Stroke systems of care need to take advantage of any opportunity to treat patients early, wherever they are.”

The study was partly funded by a Stryker Foundation grant.

LOS ANGELES – Evidence continues to mount that in the new era of thrombectomy treatment for selected acute ischemic stroke patients outcomes are better when patients go directly to the closest comprehensive stroke center that offers intravascular procedures rather than first being taken to a closer hospital and then needing transfer.

Nils H. Mueller-Kronast, MD, presented a modeled analysis of data collected in a registry on 236 real-world U.S. patients who underwent mechanical thrombectomy for an acute, large-vessel occlusion stroke following transfer from a hospital that could perform thrombolysis but couldn’t offer thrombectomy. The analysis showed that if the patients had instead gone directly to the closest thrombectomy center the result would have been a 16-percentage-point increase in patients with a modified Rankin Scale (mRS) score of 0-1 after 90 days, and a 9-percentage-point increase in mRS 0-2 outcomes, Dr. Mueller-Kronast said at the International Stroke Conference, sponsored by the American Heart Association.

Mitchel L. Zoler/Frontline Medical News

The current analysis focused on 236 of the transferred patients with complete information on their location at the time of their stroke and subsequent time intervals during their transport and treatment, including 117 patients with ground transfer from their first hospital to the thrombectomy site, 114 with air transfer, and 5 with an unreported means of transport.

Dr. Mueller-Kronast and his associates calculated the time it would have taken each of the 117 ground transported patients to have gone directly to the closest thrombectomy center (adjusted by traffic conditions at the time of the stroke), and modeled the likely outcomes of these patients based on the data collected in the registry. This projected a 47% rate of mRS scores 0-1 (good outcomes) after 90 days, and a 60% rate of mRS 0-2 scores with a direct-to-thrombectomy strategy, compared with actual rates of 31% and 51%, respectively, among the patients who were transferred from their initial hospital.

“Bypass to an endovascular-capable center may be an option to improve rapid access to mechanical thrombectomy,” he concluded.

The STRATIS registry is sponsored by Medtronic. Dr. Mueller-Kronast has been a consultant to Medtronic.

[email protected]

SOURCE: Mueller-Kronast N et al. Abstract LB12.

LOS ANGELES – Evidence continues to mount that in the new era of thrombectomy treatment for selected acute ischemic stroke patients outcomes are better when patients go directly to the closest comprehensive stroke center that offers intravascular procedures rather than first being taken to a closer hospital and then needing transfer.

Nils H. Mueller-Kronast, MD, presented a modeled analysis of data collected in a registry on 236 real-world U.S. patients who underwent mechanical thrombectomy for an acute, large-vessel occlusion stroke following transfer from a hospital that could perform thrombolysis but couldn’t offer thrombectomy. The analysis showed that if the patients had instead gone directly to the closest thrombectomy center the result would have been a 16-percentage-point increase in patients with a modified Rankin Scale (mRS) score of 0-1 after 90 days, and a 9-percentage-point increase in mRS 0-2 outcomes, Dr. Mueller-Kronast said at the International Stroke Conference, sponsored by the American Heart Association.

Mitchel L. Zoler/Frontline Medical News

The current analysis focused on 236 of the transferred patients with complete information on their location at the time of their stroke and subsequent time intervals during their transport and treatment, including 117 patients with ground transfer from their first hospital to the thrombectomy site, 114 with air transfer, and 5 with an unreported means of transport.

Dr. Mueller-Kronast and his associates calculated the time it would have taken each of the 117 ground transported patients to have gone directly to the closest thrombectomy center (adjusted by traffic conditions at the time of the stroke), and modeled the likely outcomes of these patients based on the data collected in the registry. This projected a 47% rate of mRS scores 0-1 (good outcomes) after 90 days, and a 60% rate of mRS 0-2 scores with a direct-to-thrombectomy strategy, compared with actual rates of 31% and 51%, respectively, among the patients who were transferred from their initial hospital.

“Bypass to an endovascular-capable center may be an option to improve rapid access to mechanical thrombectomy,” he concluded.

The STRATIS registry is sponsored by Medtronic. Dr. Mueller-Kronast has been a consultant to Medtronic.

[email protected]

SOURCE: Mueller-Kronast N et al. Abstract LB12.

LOS ANGELES – Evidence continues to mount that in the new era of thrombectomy treatment for selected acute ischemic stroke patients outcomes are better when patients go directly to the closest comprehensive stroke center that offers intravascular procedures rather than first being taken to a closer hospital and then needing transfer.

Nils H. Mueller-Kronast, MD, presented a modeled analysis of data collected in a registry on 236 real-world U.S. patients who underwent mechanical thrombectomy for an acute, large-vessel occlusion stroke following transfer from a hospital that could perform thrombolysis but couldn’t offer thrombectomy. The analysis showed that if the patients had instead gone directly to the closest thrombectomy center the result would have been a 16-percentage-point increase in patients with a modified Rankin Scale (mRS) score of 0-1 after 90 days, and a 9-percentage-point increase in mRS 0-2 outcomes, Dr. Mueller-Kronast said at the International Stroke Conference, sponsored by the American Heart Association.

Mitchel L. Zoler/Frontline Medical News

The current analysis focused on 236 of the transferred patients with complete information on their location at the time of their stroke and subsequent time intervals during their transport and treatment, including 117 patients with ground transfer from their first hospital to the thrombectomy site, 114 with air transfer, and 5 with an unreported means of transport.

Dr. Mueller-Kronast and his associates calculated the time it would have taken each of the 117 ground transported patients to have gone directly to the closest thrombectomy center (adjusted by traffic conditions at the time of the stroke), and modeled the likely outcomes of these patients based on the data collected in the registry. This projected a 47% rate of mRS scores 0-1 (good outcomes) after 90 days, and a 60% rate of mRS 0-2 scores with a direct-to-thrombectomy strategy, compared with actual rates of 31% and 51%, respectively, among the patients who were transferred from their initial hospital.

“Bypass to an endovascular-capable center may be an option to improve rapid access to mechanical thrombectomy,” he concluded.

The STRATIS registry is sponsored by Medtronic. Dr. Mueller-Kronast has been a consultant to Medtronic.

[email protected]

SOURCE: Mueller-Kronast N et al. Abstract LB12.

LOS ANGELES – An emergency medical services protocol to identify large vessel occlusions and deliver patients to a comprehensive stroke center if it is within 30 minutes of travel time reduced the time to recanalization when compared against a separate protocol that optimized transfer of such patients from primary to comprehensive stroke centers.

The findings, which come from a sequential study conducted in an urban Rhode Island region, offer evidence to resolve the controversy over whether field triage in emergency medical services (EMS) units will improve outcomes, because field stroke severity scores won’t always be accurate, and longer travel to a comprehensive stroke center (CSC) could delay treatment to a patient who doesn’t need thrombectomy.

Jim Kling/Frontline Medical News

[email protected]

SOURCE: Jayaraman M et al. ISC 2018 Abstract 95 (Stroke. 2018 Jan;49[Suppl 1]:A95)

LOS ANGELES – An emergency medical services protocol to identify large vessel occlusions and deliver patients to a comprehensive stroke center if it is within 30 minutes of travel time reduced the time to recanalization when compared against a separate protocol that optimized transfer of such patients from primary to comprehensive stroke centers.

The findings, which come from a sequential study conducted in an urban Rhode Island region, offer evidence to resolve the controversy over whether field triage in emergency medical services (EMS) units will improve outcomes, because field stroke severity scores won’t always be accurate, and longer travel to a comprehensive stroke center (CSC) could delay treatment to a patient who doesn’t need thrombectomy.

Jim Kling/Frontline Medical News

[email protected]

SOURCE: Jayaraman M et al. ISC 2018 Abstract 95 (Stroke. 2018 Jan;49[Suppl 1]:A95)

LOS ANGELES – An emergency medical services protocol to identify large vessel occlusions and deliver patients to a comprehensive stroke center if it is within 30 minutes of travel time reduced the time to recanalization when compared against a separate protocol that optimized transfer of such patients from primary to comprehensive stroke centers.

The findings, which come from a sequential study conducted in an urban Rhode Island region, offer evidence to resolve the controversy over whether field triage in emergency medical services (EMS) units will improve outcomes, because field stroke severity scores won’t always be accurate, and longer travel to a comprehensive stroke center (CSC) could delay treatment to a patient who doesn’t need thrombectomy.

Jim Kling/Frontline Medical News

[email protected]

SOURCE: Jayaraman M et al. ISC 2018 Abstract 95 (Stroke. 2018 Jan;49[Suppl 1]:A95)

MITCHEL L. ZOLER

FRONTLINE MEDICAL NEWS

Mobile stroke units—specially equipped ambulances that bring a diagnostic computed tomography (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 US mobile stroke unit (MSU) launched in Houston, Texas in early 2014 (following the world’s first in Berlin, Germany, which began running in early 2011), and by early 2017, at least eight other US MSUs were in operation, most of them put into service during the prior 15 months. United States MSU locations now include Cleveland, Ohio; Denver, Colorado; Memphis, Tennessee; New York, New York; Toledo, Ohio; Trenton, New Jersey; and Northwestern Medicine and Rush University Medical Center in the western Chicago, Illinois 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 initiate thrombolytic therapy with tissue plasminogen activator (tPA), 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 an MSU on the road for the first time; they are 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 US 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 US MSUs.

“We believe that MSUs are very worthwhile and that the clinical and economic benefits of earlier stroke treatment [made possible with MSUs] could offset the costs, but we need to show this,” admitted May Nour, MD, a vascular and interventional neurologist at the University of California, Los Angeles (UCLA), and director of the soon-to-launch Los Angeles MSU.

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.

In addition, many MSUs now carry a scanner that can perform a CT angiogram (CTA) to locate the occluding clot. If a large vessel occlusion is found, the crew can bring the patient directly to a comprehensive stroke center for a thrombectomy. If thrombectomy is not appropriate, the MSU crew may take the patient to a primary stroke center where thrombectomy is not available.

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 the Berlin group published in September 2016 that compared the treatment courses and outcomes of patients managed with an MSU to 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.¹ However, the study found no significant difference for its primary endpoint: the percentage of patients with a modified Rankin Scale score of 1 or lower 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

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 EDs operated by the Cleveland Clinic, a statistically significant difference.² However, this report included no data on clinical outcomes.

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.

During his talk at the same session, Dr Grotta ran through the numbers for the Houston program. They spent $1.1 million to put their MSU into service in early 2014, and, based on the expenses accrued since then, he estimated an annual staffing cost of about $400,000 and an annual operating cost of about $100,000, for a total estimated 5-year cost of about $3.6 million. Staffing of the Houston MSU started with a registered nurse, CT technician, paramedic, and vascular neurologist, although, like most other US MSUs, the onboard neurologist has since been replaced by a second paramedic, and the neurological diagnostic consult is done via a telemedicine link.

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 neurological 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,³ 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, which Dr Wu reported was something not formally examined in the study.

However, telemedicine assessment of CT results gathered in an MSU has one major limitation: the time needed to transmit the huge amount of information from a CTA.

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 CTA is 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 nonsustainable. 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.⁴ “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. 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 (NY) 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 US 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 bring the number up to 1,000 patients.

“We are following the health care 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.

References

1. Kunz A, Ebinger M, Geisler F, et al. Functional outcomes of pre-hospital thrombolysis in a mobile stroke treatment unit compared with conventional care: an observational registry study. Lancet Neurol. 2016;15(10):1035-1043. doi:10.1016/S1474-4422(16)30129-6.

2. Taqui A, Cerejo R, Itrat A, et al; Cleveland Pre-Hospital Acute Stroke Treatment (PHAST) Group. Reduction in time to treatment in prehospital telemedicine evaluation and thrombolysis. Neurology. 2017 March 8. [Epub ahead of print]. doi:10.1212/WNL.0000000000003786.

3. Ramadan AR, Denny MC, Vahidy F, et al. Agreement among stroke faculty and fellows in treating ischemic stroke patients with tissue-type plasminogen activator and thrombectomy. Stroke. 2017;48(1):222-224. doi:10.1161/STROKEAHA.116.015214.

4. Southerland AM, Brandler ES. The cost-efficiency of mobile stroke units: Where the rubber meets the road. Neurology. 2017 Mar 8. [Epub ahead of print]. doi:10.1212/WNL.0000000000003833.

Pulmonary Embolism Common in Patients With Acute Exacerbations of COPD

JIM KLING

FRONTLINE MEDICAL NEWS

About 16% of patients with unexplained acute exacerbations of chronic obstructive pulmonary disease (AECOPD) had an accompanying pulmonary embolism (PE), usually in regions that could be targeted with anticoagulants, according to a new systematic review and meta-analysis.

Approximately 70% of AECOPD cases develop in response to an infection, but about 30% of the time, an AE has no clear cause, the authors said in a report on their research. There is a known biological link between inflammation and coagulation, which suggests that patients experiencing AECOPD may be at increased risk of PE.

The researchers reviewed and analyzed seven studies, comprising 880 patients. Among the authors’ reasons for conducting this research was to update the pooled prevalence of PE in AECOPD from a previous systematic review published in Chest in 2009.

The meta-analysis revealed that 16.1% of patients with AECOPD were also diagnosed with PE (95% confidence interval [CI], 8.3%-25.8%). There was a wide range of variation between individual studies (prevalence 3.3%-29.1%). In six studies that reported on deep vein thrombosis (DVT), the pooled prevalence of DVT was 10.5% (95% CI, 4.3%-19.0%).

Five of the studies identified the PE location. An analysis of those studies showed that 35% were in the main pulmonary artery, and 31.7% were in the lobar and interlobar arteries. Such findings “[suggest] that the majority of these embolisms have important clinical consequences,” the authors wrote.

The researchers also looked at clinical markers that accompanied AECOPD and found a potential signal with respect to pleuritic chest pain. One study found a strong association between pleuritic chest pain and AECOPD patients with PE (81% vs 40% in those without PE). A second study showed a similar association (24% in PE vs 11.5% in non-PE patients), and a third study found no significant difference.

The presence of PE was also linked to hypotension, syncope, and acute right failure on ultrasonography, suggesting that PE may be associated with heart failure.

Patients with PE were less likely to have symptoms consistent with a respiratory tract infection. They also tended to have higher mortality rates and longer hospitalization rates compared with those without PE.

The meta-analysis had some limitations, including the heterogeneity of findings in the included studies, as well as the potential for publication bias, since reports showing unusually low or high rates may be more likely to be published, the researchers noted. There was also a high proportion of male subjects in the included studies.

Overall, the researchers concluded that PE is more likely in patients with pleuritic chest pain and signs of heart failure, and less likely in patients with signs of a respiratory infection. That information “might add to the clinical decision-making in patients with an AECOPD, because it would be undesirable to perform [CT pulmonary angiography] in every patient with an AECOPD,” the researchers wrote.

Aleva FE, Voets LW, Simons SO, de Mast Q, van der Ven AJ, Heijdra YF. Prevalence and localization of pulmonary embolism in unexplained acute exacerbations of COPD: A systematic review and meta-analysis. Chest. 2017;151(3):544-554. doi:10.1016/j.chest.2016.07.034.

Norepinephrine Shortage Linked to Mortality in Patients With Septic Shock

AMY KARON

FRONTLINE MEDICAL NEWS

A national shortage of norepinephrine in the United States was associated with higher rates of mortality among patients hospitalized with septic shock, investigators reported.

Rates of in-hospital mortality in 2011 were 40% during quarters when hospitals were facing shortages and 36% when they were not, Emily Vail, MD, and her associates said at the International Symposium on Intensive Care and Emergency Medicine. The report was published simultaneously in JAMA.

The link between norepinephrine shortage and death from septic shock persisted even after the researchers accounted for numerous clinical and demographic factors (adjusted odds ratio, 1.2; 95% CI, 1.01 to 1.30; P = .03), wrote Dr Vail of Columbia University, New York.

Drug shortages are common in the United States, but few studies have explored their effects on patient outcomes. Investigators compared mortality rates among affected patients during 3-month intervals when hospitals were and were not using at least 20% less norepinephrine than baseline. The researchers used Premier Healthcare Database, which includes both standard claims and detailed, dated logs of all services billed to patients or insurance, with minimal missing data.

A total of 77% patients admitted with septic shock received norepinephrine before the shortage. During the lowest point of the shortage, 56% of patients received it, the researchers reported. Clinicians most often used phenylephrine instead, prescribing it to up to 54% of patients during the worst time of the shortage. The absolute increase in mortality during the quarters of shortage was 3.7% (95% CI, 1.5%-6.0%).

Several factors might explain the link between norepinephrine shortage and mortality, the investigators said. The vasopressors chosen to replace norepinephrine might result directly in worse outcomes, but a decrease in norepinephrine use also might be a proxy for relevant variables such as delayed use of vasopressors, lack of knowledge of how to optimally dose vasopressors besides norepinephrine, or the absence of a pharmacist dedicated to helping optimize the use of limited supplies.

The study did not uncover a dose-response association between greater decreases in norepinephrine use and increased mortality, the researchers noted. “This may be due to a threshold effect of vasopressor shortage on mortality, or lack of power due to relatively few hospital quarters at the extreme levels of vasopressor shortage,” they wrote.

Because the deaths captured included only those that occurred in-hospital, “the results may have underestimated mortality, particularly for hospitals that tend to transfer patients early to other skilled care facilities,” the researchers noted.

The cohort of patients was limited to those who received vasopressors for 2 or more days and excluded patients who died on the first day of vasopressor treatment, the researchers said.

Vail E, Gershengorn HB, Hua M, Walkey AJ, Rubenfeld G, Wunsch H. Association between US norepinephrine shortage and mortality among patients with septic shock. JAMA.  21 March 2017. [Epub ahead of print]. doi:10.1001/jama.2017.2841.

MITCHEL L. ZOLER

FRONTLINE MEDICAL NEWS

Mobile stroke units—specially equipped ambulances that bring a diagnostic computed tomography (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 US mobile stroke unit (MSU) launched in Houston, Texas in early 2014 (following the world’s first in Berlin, Germany, which began running in early 2011), and by early 2017, at least eight other US MSUs were in operation, most of them put into service during the prior 15 months. United States MSU locations now include Cleveland, Ohio; Denver, Colorado; Memphis, Tennessee; New York, New York; Toledo, Ohio; Trenton, New Jersey; and Northwestern Medicine and Rush University Medical Center in the western Chicago, Illinois 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 initiate thrombolytic therapy with tissue plasminogen activator (tPA), 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 an MSU on the road for the first time; they are 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 US 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 US MSUs.

“We believe that MSUs are very worthwhile and that the clinical and economic benefits of earlier stroke treatment [made possible with MSUs] could offset the costs, but we need to show this,” admitted May Nour, MD, a vascular and interventional neurologist at the University of California, Los Angeles (UCLA), and director of the soon-to-launch Los Angeles MSU.

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.

In addition, many MSUs now carry a scanner that can perform a CT angiogram (CTA) to locate the occluding clot. If a large vessel occlusion is found, the crew can bring the patient directly to a comprehensive stroke center for a thrombectomy. If thrombectomy is not appropriate, the MSU crew may take the patient to a primary stroke center where thrombectomy is not available.

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 the Berlin group published in September 2016 that compared the treatment courses and outcomes of patients managed with an MSU to 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.¹ However, the study found no significant difference for its primary endpoint: the percentage of patients with a modified Rankin Scale score of 1 or lower 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

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 EDs operated by the Cleveland Clinic, a statistically significant difference.² However, this report included no data on clinical outcomes.

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.

During his talk at the same session, Dr Grotta ran through the numbers for the Houston program. They spent $1.1 million to put their MSU into service in early 2014, and, based on the expenses accrued since then, he estimated an annual staffing cost of about $400,000 and an annual operating cost of about $100,000, for a total estimated 5-year cost of about $3.6 million. Staffing of the Houston MSU started with a registered nurse, CT technician, paramedic, and vascular neurologist, although, like most other US MSUs, the onboard neurologist has since been replaced by a second paramedic, and the neurological diagnostic consult is done via a telemedicine link.

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 neurological 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,³ 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, which Dr Wu reported was something not formally examined in the study.

However, telemedicine assessment of CT results gathered in an MSU has one major limitation: the time needed to transmit the huge amount of information from a CTA.

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 CTA is 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 nonsustainable. 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.⁴ “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. 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 (NY) 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 US 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 bring the number up to 1,000 patients.

“We are following the health care 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.

References

1. Kunz A, Ebinger M, Geisler F, et al. Functional outcomes of pre-hospital thrombolysis in a mobile stroke treatment unit compared with conventional care: an observational registry study. Lancet Neurol. 2016;15(10):1035-1043. doi:10.1016/S1474-4422(16)30129-6.

2. Taqui A, Cerejo R, Itrat A, et al; Cleveland Pre-Hospital Acute Stroke Treatment (PHAST) Group. Reduction in time to treatment in prehospital telemedicine evaluation and thrombolysis. Neurology. 2017 March 8. [Epub ahead of print]. doi:10.1212/WNL.0000000000003786.

3. Ramadan AR, Denny MC, Vahidy F, et al. Agreement among stroke faculty and fellows in treating ischemic stroke patients with tissue-type plasminogen activator and thrombectomy. Stroke. 2017;48(1):222-224. doi:10.1161/STROKEAHA.116.015214.

4. Southerland AM, Brandler ES. The cost-efficiency of mobile stroke units: Where the rubber meets the road. Neurology. 2017 Mar 8. [Epub ahead of print]. doi:10.1212/WNL.0000000000003833.

Pulmonary Embolism Common in Patients With Acute Exacerbations of COPD

JIM KLING

FRONTLINE MEDICAL NEWS

About 16% of patients with unexplained acute exacerbations of chronic obstructive pulmonary disease (AECOPD) had an accompanying pulmonary embolism (PE), usually in regions that could be targeted with anticoagulants, according to a new systematic review and meta-analysis.

Approximately 70% of AECOPD cases develop in response to an infection, but about 30% of the time, an AE has no clear cause, the authors said in a report on their research. There is a known biological link between inflammation and coagulation, which suggests that patients experiencing AECOPD may be at increased risk of PE.

The researchers reviewed and analyzed seven studies, comprising 880 patients. Among the authors’ reasons for conducting this research was to update the pooled prevalence of PE in AECOPD from a previous systematic review published in Chest in 2009.

The meta-analysis revealed that 16.1% of patients with AECOPD were also diagnosed with PE (95% confidence interval [CI], 8.3%-25.8%). There was a wide range of variation between individual studies (prevalence 3.3%-29.1%). In six studies that reported on deep vein thrombosis (DVT), the pooled prevalence of DVT was 10.5% (95% CI, 4.3%-19.0%).

Five of the studies identified the PE location. An analysis of those studies showed that 35% were in the main pulmonary artery, and 31.7% were in the lobar and interlobar arteries. Such findings “[suggest] that the majority of these embolisms have important clinical consequences,” the authors wrote.

The researchers also looked at clinical markers that accompanied AECOPD and found a potential signal with respect to pleuritic chest pain. One study found a strong association between pleuritic chest pain and AECOPD patients with PE (81% vs 40% in those without PE). A second study showed a similar association (24% in PE vs 11.5% in non-PE patients), and a third study found no significant difference.

The presence of PE was also linked to hypotension, syncope, and acute right failure on ultrasonography, suggesting that PE may be associated with heart failure.

Patients with PE were less likely to have symptoms consistent with a respiratory tract infection. They also tended to have higher mortality rates and longer hospitalization rates compared with those without PE.

The meta-analysis had some limitations, including the heterogeneity of findings in the included studies, as well as the potential for publication bias, since reports showing unusually low or high rates may be more likely to be published, the researchers noted. There was also a high proportion of male subjects in the included studies.

Overall, the researchers concluded that PE is more likely in patients with pleuritic chest pain and signs of heart failure, and less likely in patients with signs of a respiratory infection. That information “might add to the clinical decision-making in patients with an AECOPD, because it would be undesirable to perform [CT pulmonary angiography] in every patient with an AECOPD,” the researchers wrote.

Aleva FE, Voets LW, Simons SO, de Mast Q, van der Ven AJ, Heijdra YF. Prevalence and localization of pulmonary embolism in unexplained acute exacerbations of COPD: A systematic review and meta-analysis. Chest. 2017;151(3):544-554. doi:10.1016/j.chest.2016.07.034.

Norepinephrine Shortage Linked to Mortality in Patients With Septic Shock

AMY KARON

FRONTLINE MEDICAL NEWS

A national shortage of norepinephrine in the United States was associated with higher rates of mortality among patients hospitalized with septic shock, investigators reported.

Rates of in-hospital mortality in 2011 were 40% during quarters when hospitals were facing shortages and 36% when they were not, Emily Vail, MD, and her associates said at the International Symposium on Intensive Care and Emergency Medicine. The report was published simultaneously in JAMA.

The link between norepinephrine shortage and death from septic shock persisted even after the researchers accounted for numerous clinical and demographic factors (adjusted odds ratio, 1.2; 95% CI, 1.01 to 1.30; P = .03), wrote Dr Vail of Columbia University, New York.

Drug shortages are common in the United States, but few studies have explored their effects on patient outcomes. Investigators compared mortality rates among affected patients during 3-month intervals when hospitals were and were not using at least 20% less norepinephrine than baseline. The researchers used Premier Healthcare Database, which includes both standard claims and detailed, dated logs of all services billed to patients or insurance, with minimal missing data.

A total of 77% patients admitted with septic shock received norepinephrine before the shortage. During the lowest point of the shortage, 56% of patients received it, the researchers reported. Clinicians most often used phenylephrine instead, prescribing it to up to 54% of patients during the worst time of the shortage. The absolute increase in mortality during the quarters of shortage was 3.7% (95% CI, 1.5%-6.0%).

Several factors might explain the link between norepinephrine shortage and mortality, the investigators said. The vasopressors chosen to replace norepinephrine might result directly in worse outcomes, but a decrease in norepinephrine use also might be a proxy for relevant variables such as delayed use of vasopressors, lack of knowledge of how to optimally dose vasopressors besides norepinephrine, or the absence of a pharmacist dedicated to helping optimize the use of limited supplies.

The study did not uncover a dose-response association between greater decreases in norepinephrine use and increased mortality, the researchers noted. “This may be due to a threshold effect of vasopressor shortage on mortality, or lack of power due to relatively few hospital quarters at the extreme levels of vasopressor shortage,” they wrote.

Because the deaths captured included only those that occurred in-hospital, “the results may have underestimated mortality, particularly for hospitals that tend to transfer patients early to other skilled care facilities,” the researchers noted.

The cohort of patients was limited to those who received vasopressors for 2 or more days and excluded patients who died on the first day of vasopressor treatment, the researchers said.

Vail E, Gershengorn HB, Hua M, Walkey AJ, Rubenfeld G, Wunsch H. Association between US norepinephrine shortage and mortality among patients with septic shock. JAMA.  21 March 2017. [Epub ahead of print]. doi:10.1001/jama.2017.2841.

MITCHEL L. ZOLER

FRONTLINE MEDICAL NEWS

Mobile stroke units—specially equipped ambulances that bring a diagnostic computed tomography (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 US mobile stroke unit (MSU) launched in Houston, Texas in early 2014 (following the world’s first in Berlin, Germany, which began running in early 2011), and by early 2017, at least eight other US MSUs were in operation, most of them put into service during the prior 15 months. United States MSU locations now include Cleveland, Ohio; Denver, Colorado; Memphis, Tennessee; New York, New York; Toledo, Ohio; Trenton, New Jersey; and Northwestern Medicine and Rush University Medical Center in the western Chicago, Illinois 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 initiate thrombolytic therapy with tissue plasminogen activator (tPA), 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 an MSU on the road for the first time; they are 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 US 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 US MSUs.

“We believe that MSUs are very worthwhile and that the clinical and economic benefits of earlier stroke treatment [made possible with MSUs] could offset the costs, but we need to show this,” admitted May Nour, MD, a vascular and interventional neurologist at the University of California, Los Angeles (UCLA), and director of the soon-to-launch Los Angeles MSU.

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.

In addition, many MSUs now carry a scanner that can perform a CT angiogram (CTA) to locate the occluding clot. If a large vessel occlusion is found, the crew can bring the patient directly to a comprehensive stroke center for a thrombectomy. If thrombectomy is not appropriate, the MSU crew may take the patient to a primary stroke center where thrombectomy is not available.

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 the Berlin group published in September 2016 that compared the treatment courses and outcomes of patients managed with an MSU to 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.¹ However, the study found no significant difference for its primary endpoint: the percentage of patients with a modified Rankin Scale score of 1 or lower 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

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 EDs operated by the Cleveland Clinic, a statistically significant difference.² However, this report included no data on clinical outcomes.

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.

During his talk at the same session, Dr Grotta ran through the numbers for the Houston program. They spent $1.1 million to put their MSU into service in early 2014, and, based on the expenses accrued since then, he estimated an annual staffing cost of about $400,000 and an annual operating cost of about $100,000, for a total estimated 5-year cost of about $3.6 million. Staffing of the Houston MSU started with a registered nurse, CT technician, paramedic, and vascular neurologist, although, like most other US MSUs, the onboard neurologist has since been replaced by a second paramedic, and the neurological diagnostic consult is done via a telemedicine link.

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 neurological 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,³ 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, which Dr Wu reported was something not formally examined in the study.

However, telemedicine assessment of CT results gathered in an MSU has one major limitation: the time needed to transmit the huge amount of information from a CTA.

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 CTA is 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 nonsustainable. 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.⁴ “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. 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 (NY) 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 US 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 bring the number up to 1,000 patients.

“We are following the health care 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.

References

1. Kunz A, Ebinger M, Geisler F, et al. Functional outcomes of pre-hospital thrombolysis in a mobile stroke treatment unit compared with conventional care: an observational registry study. Lancet Neurol. 2016;15(10):1035-1043. doi:10.1016/S1474-4422(16)30129-6.

2. Taqui A, Cerejo R, Itrat A, et al; Cleveland Pre-Hospital Acute Stroke Treatment (PHAST) Group. Reduction in time to treatment in prehospital telemedicine evaluation and thrombolysis. Neurology. 2017 March 8. [Epub ahead of print]. doi:10.1212/WNL.0000000000003786.

3. Ramadan AR, Denny MC, Vahidy F, et al. Agreement among stroke faculty and fellows in treating ischemic stroke patients with tissue-type plasminogen activator and thrombectomy. Stroke. 2017;48(1):222-224. doi:10.1161/STROKEAHA.116.015214.

4. Southerland AM, Brandler ES. The cost-efficiency of mobile stroke units: Where the rubber meets the road. Neurology. 2017 Mar 8. [Epub ahead of print]. doi:10.1212/WNL.0000000000003833.

Pulmonary Embolism Common in Patients With Acute Exacerbations of COPD

JIM KLING

FRONTLINE MEDICAL NEWS

About 16% of patients with unexplained acute exacerbations of chronic obstructive pulmonary disease (AECOPD) had an accompanying pulmonary embolism (PE), usually in regions that could be targeted with anticoagulants, according to a new systematic review and meta-analysis.

Approximately 70% of AECOPD cases develop in response to an infection, but about 30% of the time, an AE has no clear cause, the authors said in a report on their research. There is a known biological link between inflammation and coagulation, which suggests that patients experiencing AECOPD may be at increased risk of PE.

The researchers reviewed and analyzed seven studies, comprising 880 patients. Among the authors’ reasons for conducting this research was to update the pooled prevalence of PE in AECOPD from a previous systematic review published in Chest in 2009.

The meta-analysis revealed that 16.1% of patients with AECOPD were also diagnosed with PE (95% confidence interval [CI], 8.3%-25.8%). There was a wide range of variation between individual studies (prevalence 3.3%-29.1%). In six studies that reported on deep vein thrombosis (DVT), the pooled prevalence of DVT was 10.5% (95% CI, 4.3%-19.0%).

Five of the studies identified the PE location. An analysis of those studies showed that 35% were in the main pulmonary artery, and 31.7% were in the lobar and interlobar arteries. Such findings “[suggest] that the majority of these embolisms have important clinical consequences,” the authors wrote.

The researchers also looked at clinical markers that accompanied AECOPD and found a potential signal with respect to pleuritic chest pain. One study found a strong association between pleuritic chest pain and AECOPD patients with PE (81% vs 40% in those without PE). A second study showed a similar association (24% in PE vs 11.5% in non-PE patients), and a third study found no significant difference.

The presence of PE was also linked to hypotension, syncope, and acute right failure on ultrasonography, suggesting that PE may be associated with heart failure.

Patients with PE were less likely to have symptoms consistent with a respiratory tract infection. They also tended to have higher mortality rates and longer hospitalization rates compared with those without PE.

The meta-analysis had some limitations, including the heterogeneity of findings in the included studies, as well as the potential for publication bias, since reports showing unusually low or high rates may be more likely to be published, the researchers noted. There was also a high proportion of male subjects in the included studies.

Overall, the researchers concluded that PE is more likely in patients with pleuritic chest pain and signs of heart failure, and less likely in patients with signs of a respiratory infection. That information “might add to the clinical decision-making in patients with an AECOPD, because it would be undesirable to perform [CT pulmonary angiography] in every patient with an AECOPD,” the researchers wrote.

Aleva FE, Voets LW, Simons SO, de Mast Q, van der Ven AJ, Heijdra YF. Prevalence and localization of pulmonary embolism in unexplained acute exacerbations of COPD: A systematic review and meta-analysis. Chest. 2017;151(3):544-554. doi:10.1016/j.chest.2016.07.034.

Norepinephrine Shortage Linked to Mortality in Patients With Septic Shock

AMY KARON

FRONTLINE MEDICAL NEWS

A national shortage of norepinephrine in the United States was associated with higher rates of mortality among patients hospitalized with septic shock, investigators reported.

Rates of in-hospital mortality in 2011 were 40% during quarters when hospitals were facing shortages and 36% when they were not, Emily Vail, MD, and her associates said at the International Symposium on Intensive Care and Emergency Medicine. The report was published simultaneously in JAMA.

The link between norepinephrine shortage and death from septic shock persisted even after the researchers accounted for numerous clinical and demographic factors (adjusted odds ratio, 1.2; 95% CI, 1.01 to 1.30; P = .03), wrote Dr Vail of Columbia University, New York.

Drug shortages are common in the United States, but few studies have explored their effects on patient outcomes. Investigators compared mortality rates among affected patients during 3-month intervals when hospitals were and were not using at least 20% less norepinephrine than baseline. The researchers used Premier Healthcare Database, which includes both standard claims and detailed, dated logs of all services billed to patients or insurance, with minimal missing data.

A total of 77% patients admitted with septic shock received norepinephrine before the shortage. During the lowest point of the shortage, 56% of patients received it, the researchers reported. Clinicians most often used phenylephrine instead, prescribing it to up to 54% of patients during the worst time of the shortage. The absolute increase in mortality during the quarters of shortage was 3.7% (95% CI, 1.5%-6.0%).

Several factors might explain the link between norepinephrine shortage and mortality, the investigators said. The vasopressors chosen to replace norepinephrine might result directly in worse outcomes, but a decrease in norepinephrine use also might be a proxy for relevant variables such as delayed use of vasopressors, lack of knowledge of how to optimally dose vasopressors besides norepinephrine, or the absence of a pharmacist dedicated to helping optimize the use of limited supplies.

The study did not uncover a dose-response association between greater decreases in norepinephrine use and increased mortality, the researchers noted. “This may be due to a threshold effect of vasopressor shortage on mortality, or lack of power due to relatively few hospital quarters at the extreme levels of vasopressor shortage,” they wrote.

Because the deaths captured included only those that occurred in-hospital, “the results may have underestimated mortality, particularly for hospitals that tend to transfer patients early to other skilled care facilities,” the researchers noted.

The cohort of patients was limited to those who received vasopressors for 2 or more days and excluded patients who died on the first day of vasopressor treatment, the researchers said.

Vail E, Gershengorn HB, Hua M, Walkey AJ, Rubenfeld G, Wunsch H. Association between US norepinephrine shortage and mortality among patients with septic shock. JAMA.  21 March 2017. [Epub ahead of print]. doi:10.1001/jama.2017.2841.

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.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel Zoler/Frontline Medical News

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.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel Zoler/Frontline Medical News

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.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel Zoler/Frontline Medical News

NEW ORLEANS – The severity and duration of hypotension in traumatic brain injury patients during EMS transport to an emergency department has a tight and essentially linear relationship to their mortality rate during subsequent weeks of recovery, according to an analysis of more than 7,500 brain-injured patients.

For each doubling of the combined severity and duration of hypotension during the prehospital period, when systolic blood pressure was less than 90 mm Hg, patient mortality rose by 19%, Daniel W. Spaite, MD, reported at the American Heart Association scientific sessions.

However, the results do not address whether aggressive treatment of hypotension by EMS technicians in a patient with traumatic brain injury (TBI) leads to reduced mortality. That question is being assessed as part of the primary endpoint of the Excellence in Prehospital Injury Care-Traumatic Brain Injury (EPIC-TBI) study, which should have an answer by the end of 2017, said Dr. Spaite, professor of emergency medicine at the University of Arizona in Tuscon.

Mitchel L. Zoler/Frontline Medical News

[email protected] On Twitter @mitchelzoler

NEW ORLEANS – The severity and duration of hypotension in traumatic brain injury patients during EMS transport to an emergency department has a tight and essentially linear relationship to their mortality rate during subsequent weeks of recovery, according to an analysis of more than 7,500 brain-injured patients.

For each doubling of the combined severity and duration of hypotension during the prehospital period, when systolic blood pressure was less than 90 mm Hg, patient mortality rose by 19%, Daniel W. Spaite, MD, reported at the American Heart Association scientific sessions.

However, the results do not address whether aggressive treatment of hypotension by EMS technicians in a patient with traumatic brain injury (TBI) leads to reduced mortality. That question is being assessed as part of the primary endpoint of the Excellence in Prehospital Injury Care-Traumatic Brain Injury (EPIC-TBI) study, which should have an answer by the end of 2017, said Dr. Spaite, professor of emergency medicine at the University of Arizona in Tuscon.

Mitchel L. Zoler/Frontline Medical News

[email protected] On Twitter @mitchelzoler

NEW ORLEANS – The severity and duration of hypotension in traumatic brain injury patients during EMS transport to an emergency department has a tight and essentially linear relationship to their mortality rate during subsequent weeks of recovery, according to an analysis of more than 7,500 brain-injured patients.

For each doubling of the combined severity and duration of hypotension during the prehospital period, when systolic blood pressure was less than 90 mm Hg, patient mortality rose by 19%, Daniel W. Spaite, MD, reported at the American Heart Association scientific sessions.

However, the results do not address whether aggressive treatment of hypotension by EMS technicians in a patient with traumatic brain injury (TBI) leads to reduced mortality. That question is being assessed as part of the primary endpoint of the Excellence in Prehospital Injury Care-Traumatic Brain Injury (EPIC-TBI) study, which should have an answer by the end of 2017, said Dr. Spaite, professor of emergency medicine at the University of Arizona in Tuscon.

Mitchel L. Zoler/Frontline Medical News

[email protected] On Twitter @mitchelzoler