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FDA pulls U.S. authorization for Eli Lilly’s COVID drug bebtelovimab
the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.
The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.
AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.
Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.
The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.
BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.
The subvariants accounted for around 57% of the cases nationally, as per government data last week.
Reuters Health Information © 2022
the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.
The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.
AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.
Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.
The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.
BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.
The subvariants accounted for around 57% of the cases nationally, as per government data last week.
Reuters Health Information © 2022
the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.
The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.
AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.
Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.
The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.
BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.
The subvariants accounted for around 57% of the cases nationally, as per government data last week.
Reuters Health Information © 2022
RSV surge stuns parents and strains providers, but doctors offer help
RSV cases peaked in mid-November, according to the latest Centers for Disease Control and Prevention data, with RSV-associated hospitalizations in the United States among patients 0-4 years having maxed out five times higher than they were at the same time in 2021. These surges strained providers and left parents scrambling for care. Fortunately, pediatric hospitalizations appear to be subsiding.
In interviews, the parents of the child who had a severe case of RSV reflected on their son’s bout with the illness, and doctors described challenges to dealing with the surge in RSV cases this season. The physicians also offered advice on how recognize and respond to future cases of the virus.
Sebastian Witt’s story
“I didn’t even know what RSV was,” said Malte Witt, whose son, Sebastian, 2, was recently hospitalized for RSV in Denver.
Mr. Witt and his wife, Emily Witt, both 32, thought they were dealing with a typical cold until Sebastian’s condition dramatically deteriorated about 36 hours after symptom onset.
“He basically just slumped over and collapsed, coughing uncontrollably,” Mr. Witt said in an interview. “He couldn’t catch his breath.”
The Witts rushed Sebastian to the ED at Children’s Hospital Colorado, expecting to see a doctor immediately. Instead, they spent the night in an overcrowded waiting room alongside many other families in the same situation.
“There was no room for anyone to sit anywhere,” Mr. Witt said. “There were people sitting on the floor. I counted maybe six children hooked up to oxygen when we walked in.”
After waiting approximately 45 minutes, a nurse checked Sebastian’s oxygen saturation. The readings were 79%-83%. This range is significantly below thresholds for supplemental oxygen described by most pediatric guidelines, which range from 90 to 94%.
The nurse connected Sebastian to bottled oxygen in the waiting room, and a recheck 4 hours later showed that his oxygen saturation had improved.
But the improvement didn’t last.
“At roughly hour 10 in the waiting room – it was 4 in the morning – you could tell that Seb was exhausted, really not acting like himself,” Mr. Witt said. “We thought maybe it’s just late at night, he hasn’t really slept. But then Emily noticed that his oxygen tank had run out.”
Mr. Witt told a nurse, and after another check revealed low oxygen saturation, Sebastian was finally admitted.
Early RSV surge strains pediatric providers
With RSV-associated hospitalizations peaking at 48 per 100,000 children, Colorado has been among the states hardest hit by the virus. New Mexico – where hospitalizations peaked at 56.4 per 100,000 children – comes in second. Even in states like California, where hospitalization rates have been almost 10-fold lower than New Mexico, pediatric providers have been stretched to their limits.
“Many hospitals are really being overwhelmed with admissions for RSV, both routine RSV – relatively mild hospitalizations with bronchiolitis – as well as kids in the ICU with more severe cases,” said Dean Blumberg, MD, chief of the division of pediatric infectious diseases at UC Davis Health, Sacramento, said in an interview.
Dr. Blumberg believes the severity of the 2022-2023 RSV season is likely COVID related.
“All community-associated respiratory viral infections are out of whack because of the pandemic, and all the masking and social distancing that was occurring,” he said.
This may also explain why older kids are coming down with more severe cases of RSV.
“Some children are getting RSV for the first time as older children,” Dr. Blumberg said, noting that, historically, most children were infected in the first 2 years of life. “There are reports of children 3 or 4 years of age being admitted with their first episode of RSV because of the [COVID] pandemic.”
This year’s RSV season is also notable for arriving early, potentially catching the community off guard, according to Jennifer D. Kusma, MD, a primary care pediatrician at Ann & Robert H. Lurie Children’s Hospital of Chicago.
“People who should have been protected often weren’t protected yet,” Dr. Kusma said in an interview.
Treatments new, old, and unproven
On Nov. 17, in the midst of the RSV surge, the American Academy of Pediatrics issued updated guidance for palivizumab, an RSV-targeting monoclonal antibody labeled for children at risk of severe RSV, including those with pre-existing lung or heart conditions, and infants with a history of premature birth (less than or equal to 35 weeks’ gestational age).
“If RSV disease activity persists at high levels in a given region through the fall and winter, the AAP supports providing more than five consecutive doses of palivizumab to eligible children,” the update stated.
Insurance companies appear to be responding in kind, covering additional doses for children in need.
“[Payers] have agreed that, if [palivizumab] needs to be given for an additional month or 2 or 3, then they’re making a commitment that they’ll reimburse hospitals for providing that,” Dr. Blumberg said.
For ineligible patients, such as Sebastian, who was born prematurely at 36 weeks – 1 week shy of the label requirement – treatment relies upon supportive care with oxygen and IV fluids.
At home, parents are left with simpler options.
Dr. Blumberg and Dr. Kusma recommended keeping children hydrated, maintaining humidified air, and using saline nose drops with bulb suction to clear mucus.
In the Witts’ experience, that last step may be easier said than done.
“Every time a nurse would walk into the room, Sebastian would yell: ‘Go away, doctor! I don’t want snot sucker!’” Mr. Witt said.
“If you over snot-suck, that’s really uncomfortable for the kid, and really hard for you,” Ms. Witt said. “And it doesn’t make much of a difference. It’s just very hard to find a middle ground, where you’re helping and keeping them comfortable.”
Some parents are turning to novel strategies, such as nebulized hypertonic saline, currently marketed on Amazon for children with RSV.
Although the AAP offers a weak recommendation for nebulized hypertonic saline in children hospitalized more than 72 hours, they advise against it in the emergency setting, citing inconsistent findings in clinical trials.
To any parents tempted by thousands of positive Amazon reviews, Dr. Blumberg said, “I wouldn’t waste my money on that.”
Dr. Kusma agreed.
“[Nebulized hypertonic saline] can be irritating,” she said. “It’s saltwater, essentially. If a parent is in the position where they’re worried about their child’s breathing to the point that they think they need to use it, I would err on the side of calling your pediatrician and being seen.”
Going in, coming home
Dr. Kusma said parents should seek medical attention if a child is breathing faster and working harder to get air. Increased work of breathing is characterized by pulling of the skin at the notch where the throat meets the chest bone (tracheal tugging), and flattening of the belly that makes the ribcage more prominent.
Mr. Witt saw these signs in Sebastian. He knew they were significant, because a friend who is a nurse had previously shown him some examples of children who exhibited these symptoms online.
“That’s how I knew that things were actually really dangerous,” Mr. Witt said. “Had she not shown me those videos a month and a half before this happened, I don’t know that we would have hit the alarm bell as quickly as we did.”
After spending their second night and the following day in a cramped preoperative room converted to manage overflow from the emergency department, Sebastian’s condition improved, and he was discharged. The Witts are relieved to be home, but frustrations from their ordeal remain, especially considering the estimated $5,000 in out-of-pocket costs they expect to pay.
“How is this our health care system?” Ms. Witt asked. “This is unbelievable.”
An optimistic outlook
RSV seasons typically demonstrate a clear peak, followed by a decline through the rest of the season, suggesting better times lie ahead; however, this season has been anything but typical.
“I’m hopeful that it will just go away and stay away,” Dr. Kusma said, citing this trend. “But I can’t know for sure.”
To anxious parents, Dr. Blumberg offered an optimistic view of RSV seasons to come.
“There’s hope,” he said. “There are vaccines that are being developed that are very close to FDA approval. So, it’s possible that this time next year, we might have widespread RSV vaccination available for children so that we don’t have to go through this nightmare again.”
Dr. Blumberg and Dr. Kusma disclosed no relevant conflicts of interest.
RSV cases peaked in mid-November, according to the latest Centers for Disease Control and Prevention data, with RSV-associated hospitalizations in the United States among patients 0-4 years having maxed out five times higher than they were at the same time in 2021. These surges strained providers and left parents scrambling for care. Fortunately, pediatric hospitalizations appear to be subsiding.
In interviews, the parents of the child who had a severe case of RSV reflected on their son’s bout with the illness, and doctors described challenges to dealing with the surge in RSV cases this season. The physicians also offered advice on how recognize and respond to future cases of the virus.
Sebastian Witt’s story
“I didn’t even know what RSV was,” said Malte Witt, whose son, Sebastian, 2, was recently hospitalized for RSV in Denver.
Mr. Witt and his wife, Emily Witt, both 32, thought they were dealing with a typical cold until Sebastian’s condition dramatically deteriorated about 36 hours after symptom onset.
“He basically just slumped over and collapsed, coughing uncontrollably,” Mr. Witt said in an interview. “He couldn’t catch his breath.”
The Witts rushed Sebastian to the ED at Children’s Hospital Colorado, expecting to see a doctor immediately. Instead, they spent the night in an overcrowded waiting room alongside many other families in the same situation.
“There was no room for anyone to sit anywhere,” Mr. Witt said. “There were people sitting on the floor. I counted maybe six children hooked up to oxygen when we walked in.”
After waiting approximately 45 minutes, a nurse checked Sebastian’s oxygen saturation. The readings were 79%-83%. This range is significantly below thresholds for supplemental oxygen described by most pediatric guidelines, which range from 90 to 94%.
The nurse connected Sebastian to bottled oxygen in the waiting room, and a recheck 4 hours later showed that his oxygen saturation had improved.
But the improvement didn’t last.
“At roughly hour 10 in the waiting room – it was 4 in the morning – you could tell that Seb was exhausted, really not acting like himself,” Mr. Witt said. “We thought maybe it’s just late at night, he hasn’t really slept. But then Emily noticed that his oxygen tank had run out.”
Mr. Witt told a nurse, and after another check revealed low oxygen saturation, Sebastian was finally admitted.
Early RSV surge strains pediatric providers
With RSV-associated hospitalizations peaking at 48 per 100,000 children, Colorado has been among the states hardest hit by the virus. New Mexico – where hospitalizations peaked at 56.4 per 100,000 children – comes in second. Even in states like California, where hospitalization rates have been almost 10-fold lower than New Mexico, pediatric providers have been stretched to their limits.
“Many hospitals are really being overwhelmed with admissions for RSV, both routine RSV – relatively mild hospitalizations with bronchiolitis – as well as kids in the ICU with more severe cases,” said Dean Blumberg, MD, chief of the division of pediatric infectious diseases at UC Davis Health, Sacramento, said in an interview.
Dr. Blumberg believes the severity of the 2022-2023 RSV season is likely COVID related.
“All community-associated respiratory viral infections are out of whack because of the pandemic, and all the masking and social distancing that was occurring,” he said.
This may also explain why older kids are coming down with more severe cases of RSV.
“Some children are getting RSV for the first time as older children,” Dr. Blumberg said, noting that, historically, most children were infected in the first 2 years of life. “There are reports of children 3 or 4 years of age being admitted with their first episode of RSV because of the [COVID] pandemic.”
This year’s RSV season is also notable for arriving early, potentially catching the community off guard, according to Jennifer D. Kusma, MD, a primary care pediatrician at Ann & Robert H. Lurie Children’s Hospital of Chicago.
“People who should have been protected often weren’t protected yet,” Dr. Kusma said in an interview.
Treatments new, old, and unproven
On Nov. 17, in the midst of the RSV surge, the American Academy of Pediatrics issued updated guidance for palivizumab, an RSV-targeting monoclonal antibody labeled for children at risk of severe RSV, including those with pre-existing lung or heart conditions, and infants with a history of premature birth (less than or equal to 35 weeks’ gestational age).
“If RSV disease activity persists at high levels in a given region through the fall and winter, the AAP supports providing more than five consecutive doses of palivizumab to eligible children,” the update stated.
Insurance companies appear to be responding in kind, covering additional doses for children in need.
“[Payers] have agreed that, if [palivizumab] needs to be given for an additional month or 2 or 3, then they’re making a commitment that they’ll reimburse hospitals for providing that,” Dr. Blumberg said.
For ineligible patients, such as Sebastian, who was born prematurely at 36 weeks – 1 week shy of the label requirement – treatment relies upon supportive care with oxygen and IV fluids.
At home, parents are left with simpler options.
Dr. Blumberg and Dr. Kusma recommended keeping children hydrated, maintaining humidified air, and using saline nose drops with bulb suction to clear mucus.
In the Witts’ experience, that last step may be easier said than done.
“Every time a nurse would walk into the room, Sebastian would yell: ‘Go away, doctor! I don’t want snot sucker!’” Mr. Witt said.
“If you over snot-suck, that’s really uncomfortable for the kid, and really hard for you,” Ms. Witt said. “And it doesn’t make much of a difference. It’s just very hard to find a middle ground, where you’re helping and keeping them comfortable.”
Some parents are turning to novel strategies, such as nebulized hypertonic saline, currently marketed on Amazon for children with RSV.
Although the AAP offers a weak recommendation for nebulized hypertonic saline in children hospitalized more than 72 hours, they advise against it in the emergency setting, citing inconsistent findings in clinical trials.
To any parents tempted by thousands of positive Amazon reviews, Dr. Blumberg said, “I wouldn’t waste my money on that.”
Dr. Kusma agreed.
“[Nebulized hypertonic saline] can be irritating,” she said. “It’s saltwater, essentially. If a parent is in the position where they’re worried about their child’s breathing to the point that they think they need to use it, I would err on the side of calling your pediatrician and being seen.”
Going in, coming home
Dr. Kusma said parents should seek medical attention if a child is breathing faster and working harder to get air. Increased work of breathing is characterized by pulling of the skin at the notch where the throat meets the chest bone (tracheal tugging), and flattening of the belly that makes the ribcage more prominent.
Mr. Witt saw these signs in Sebastian. He knew they were significant, because a friend who is a nurse had previously shown him some examples of children who exhibited these symptoms online.
“That’s how I knew that things were actually really dangerous,” Mr. Witt said. “Had she not shown me those videos a month and a half before this happened, I don’t know that we would have hit the alarm bell as quickly as we did.”
After spending their second night and the following day in a cramped preoperative room converted to manage overflow from the emergency department, Sebastian’s condition improved, and he was discharged. The Witts are relieved to be home, but frustrations from their ordeal remain, especially considering the estimated $5,000 in out-of-pocket costs they expect to pay.
“How is this our health care system?” Ms. Witt asked. “This is unbelievable.”
An optimistic outlook
RSV seasons typically demonstrate a clear peak, followed by a decline through the rest of the season, suggesting better times lie ahead; however, this season has been anything but typical.
“I’m hopeful that it will just go away and stay away,” Dr. Kusma said, citing this trend. “But I can’t know for sure.”
To anxious parents, Dr. Blumberg offered an optimistic view of RSV seasons to come.
“There’s hope,” he said. “There are vaccines that are being developed that are very close to FDA approval. So, it’s possible that this time next year, we might have widespread RSV vaccination available for children so that we don’t have to go through this nightmare again.”
Dr. Blumberg and Dr. Kusma disclosed no relevant conflicts of interest.
RSV cases peaked in mid-November, according to the latest Centers for Disease Control and Prevention data, with RSV-associated hospitalizations in the United States among patients 0-4 years having maxed out five times higher than they were at the same time in 2021. These surges strained providers and left parents scrambling for care. Fortunately, pediatric hospitalizations appear to be subsiding.
In interviews, the parents of the child who had a severe case of RSV reflected on their son’s bout with the illness, and doctors described challenges to dealing with the surge in RSV cases this season. The physicians also offered advice on how recognize and respond to future cases of the virus.
Sebastian Witt’s story
“I didn’t even know what RSV was,” said Malte Witt, whose son, Sebastian, 2, was recently hospitalized for RSV in Denver.
Mr. Witt and his wife, Emily Witt, both 32, thought they were dealing with a typical cold until Sebastian’s condition dramatically deteriorated about 36 hours after symptom onset.
“He basically just slumped over and collapsed, coughing uncontrollably,” Mr. Witt said in an interview. “He couldn’t catch his breath.”
The Witts rushed Sebastian to the ED at Children’s Hospital Colorado, expecting to see a doctor immediately. Instead, they spent the night in an overcrowded waiting room alongside many other families in the same situation.
“There was no room for anyone to sit anywhere,” Mr. Witt said. “There were people sitting on the floor. I counted maybe six children hooked up to oxygen when we walked in.”
After waiting approximately 45 minutes, a nurse checked Sebastian’s oxygen saturation. The readings were 79%-83%. This range is significantly below thresholds for supplemental oxygen described by most pediatric guidelines, which range from 90 to 94%.
The nurse connected Sebastian to bottled oxygen in the waiting room, and a recheck 4 hours later showed that his oxygen saturation had improved.
But the improvement didn’t last.
“At roughly hour 10 in the waiting room – it was 4 in the morning – you could tell that Seb was exhausted, really not acting like himself,” Mr. Witt said. “We thought maybe it’s just late at night, he hasn’t really slept. But then Emily noticed that his oxygen tank had run out.”
Mr. Witt told a nurse, and after another check revealed low oxygen saturation, Sebastian was finally admitted.
Early RSV surge strains pediatric providers
With RSV-associated hospitalizations peaking at 48 per 100,000 children, Colorado has been among the states hardest hit by the virus. New Mexico – where hospitalizations peaked at 56.4 per 100,000 children – comes in second. Even in states like California, where hospitalization rates have been almost 10-fold lower than New Mexico, pediatric providers have been stretched to their limits.
“Many hospitals are really being overwhelmed with admissions for RSV, both routine RSV – relatively mild hospitalizations with bronchiolitis – as well as kids in the ICU with more severe cases,” said Dean Blumberg, MD, chief of the division of pediatric infectious diseases at UC Davis Health, Sacramento, said in an interview.
Dr. Blumberg believes the severity of the 2022-2023 RSV season is likely COVID related.
“All community-associated respiratory viral infections are out of whack because of the pandemic, and all the masking and social distancing that was occurring,” he said.
This may also explain why older kids are coming down with more severe cases of RSV.
“Some children are getting RSV for the first time as older children,” Dr. Blumberg said, noting that, historically, most children were infected in the first 2 years of life. “There are reports of children 3 or 4 years of age being admitted with their first episode of RSV because of the [COVID] pandemic.”
This year’s RSV season is also notable for arriving early, potentially catching the community off guard, according to Jennifer D. Kusma, MD, a primary care pediatrician at Ann & Robert H. Lurie Children’s Hospital of Chicago.
“People who should have been protected often weren’t protected yet,” Dr. Kusma said in an interview.
Treatments new, old, and unproven
On Nov. 17, in the midst of the RSV surge, the American Academy of Pediatrics issued updated guidance for palivizumab, an RSV-targeting monoclonal antibody labeled for children at risk of severe RSV, including those with pre-existing lung or heart conditions, and infants with a history of premature birth (less than or equal to 35 weeks’ gestational age).
“If RSV disease activity persists at high levels in a given region through the fall and winter, the AAP supports providing more than five consecutive doses of palivizumab to eligible children,” the update stated.
Insurance companies appear to be responding in kind, covering additional doses for children in need.
“[Payers] have agreed that, if [palivizumab] needs to be given for an additional month or 2 or 3, then they’re making a commitment that they’ll reimburse hospitals for providing that,” Dr. Blumberg said.
For ineligible patients, such as Sebastian, who was born prematurely at 36 weeks – 1 week shy of the label requirement – treatment relies upon supportive care with oxygen and IV fluids.
At home, parents are left with simpler options.
Dr. Blumberg and Dr. Kusma recommended keeping children hydrated, maintaining humidified air, and using saline nose drops with bulb suction to clear mucus.
In the Witts’ experience, that last step may be easier said than done.
“Every time a nurse would walk into the room, Sebastian would yell: ‘Go away, doctor! I don’t want snot sucker!’” Mr. Witt said.
“If you over snot-suck, that’s really uncomfortable for the kid, and really hard for you,” Ms. Witt said. “And it doesn’t make much of a difference. It’s just very hard to find a middle ground, where you’re helping and keeping them comfortable.”
Some parents are turning to novel strategies, such as nebulized hypertonic saline, currently marketed on Amazon for children with RSV.
Although the AAP offers a weak recommendation for nebulized hypertonic saline in children hospitalized more than 72 hours, they advise against it in the emergency setting, citing inconsistent findings in clinical trials.
To any parents tempted by thousands of positive Amazon reviews, Dr. Blumberg said, “I wouldn’t waste my money on that.”
Dr. Kusma agreed.
“[Nebulized hypertonic saline] can be irritating,” she said. “It’s saltwater, essentially. If a parent is in the position where they’re worried about their child’s breathing to the point that they think they need to use it, I would err on the side of calling your pediatrician and being seen.”
Going in, coming home
Dr. Kusma said parents should seek medical attention if a child is breathing faster and working harder to get air. Increased work of breathing is characterized by pulling of the skin at the notch where the throat meets the chest bone (tracheal tugging), and flattening of the belly that makes the ribcage more prominent.
Mr. Witt saw these signs in Sebastian. He knew they were significant, because a friend who is a nurse had previously shown him some examples of children who exhibited these symptoms online.
“That’s how I knew that things were actually really dangerous,” Mr. Witt said. “Had she not shown me those videos a month and a half before this happened, I don’t know that we would have hit the alarm bell as quickly as we did.”
After spending their second night and the following day in a cramped preoperative room converted to manage overflow from the emergency department, Sebastian’s condition improved, and he was discharged. The Witts are relieved to be home, but frustrations from their ordeal remain, especially considering the estimated $5,000 in out-of-pocket costs they expect to pay.
“How is this our health care system?” Ms. Witt asked. “This is unbelievable.”
An optimistic outlook
RSV seasons typically demonstrate a clear peak, followed by a decline through the rest of the season, suggesting better times lie ahead; however, this season has been anything but typical.
“I’m hopeful that it will just go away and stay away,” Dr. Kusma said, citing this trend. “But I can’t know for sure.”
To anxious parents, Dr. Blumberg offered an optimistic view of RSV seasons to come.
“There’s hope,” he said. “There are vaccines that are being developed that are very close to FDA approval. So, it’s possible that this time next year, we might have widespread RSV vaccination available for children so that we don’t have to go through this nightmare again.”
Dr. Blumberg and Dr. Kusma disclosed no relevant conflicts of interest.
Flu, RSV infecting children at staggering rates
There has been no ebb in the flurry of respiratory illnesses infecting America’s youngest children. More pediatric wards across the country are announcing crises as beds reach capacity, the pediatric death toll jumped significantly in the past week, and sometimes children are being infected with more than one virus at a time.
In Oregon, for example, the governor announced an official state of emergency to help hospitals deal with the surge of respiratory viruses. Doernbecher Children’s Hospital in Portland, which houses half of all pediatric ICU beds statewide, moved to “crisis mode” and said every pediatric ICU bed was full, Oregon Public Broadcasting reported.
Last month, pediatricians nationwide called for a similar emergency declaration from the federal government to help them respond to the wave of illnesses, which include influenza and respiratory syncytial virus (RSV).
“What’s concerning to us are not only the number of infections, but the severity of these infections, leading to a high number of emergency room visits and hospitalizations,” pediatric infectious disease expert Oscar G. Gómez-Duarte, MD, PhD, said in a news release.
Five more pediatric deaths due to the flu were logged by the CDC in the past week, bringing the total for pediatric flu deaths this season to 12. Nearly 21 per 100,000 children ages 4 and under are being hospitalized for the flu, which is double the rate for children ages 5-17. Last year at this time, fewer than 1 child under age 4 per 100,000 were being hospitalized for the flu.
RSV rates are also stunningly high.
“If we look at CDC data, the RSV hospitalization rate is 10 times higher than usual for this point in the season,” American Medical Association Vice President Andrea Garcia, JD, said in this week’s AMA podcast. “And 171 out of every 100,000 infants younger than 6 months were hospitalized with RSV for the week ending Nov. 12. That is more than double the RSV hospitalization rate for newborns last year and seven times the rate in 2018, which is the last complete season we saw before the pandemic.”
Dr. Gómez-Duarte said hospitals are admitting children with respiratory illnesses who had otherwise been healthy, and sometimes they are even seeing patients with more than one illness.
“Yes, some children are getting what we call coinfections, where they become infected with more than one virus at a time. In some instances, a child becomes initially infected with flu, begins to recover, and subsequently comes down with rhinovirus (a common cold virus), RSV, or any other respiratory virus,” he said. “These coinfections tend to be more severe than when the child just has one infection.”
A version of this article first appeared on Medscape.com.
There has been no ebb in the flurry of respiratory illnesses infecting America’s youngest children. More pediatric wards across the country are announcing crises as beds reach capacity, the pediatric death toll jumped significantly in the past week, and sometimes children are being infected with more than one virus at a time.
In Oregon, for example, the governor announced an official state of emergency to help hospitals deal with the surge of respiratory viruses. Doernbecher Children’s Hospital in Portland, which houses half of all pediatric ICU beds statewide, moved to “crisis mode” and said every pediatric ICU bed was full, Oregon Public Broadcasting reported.
Last month, pediatricians nationwide called for a similar emergency declaration from the federal government to help them respond to the wave of illnesses, which include influenza and respiratory syncytial virus (RSV).
“What’s concerning to us are not only the number of infections, but the severity of these infections, leading to a high number of emergency room visits and hospitalizations,” pediatric infectious disease expert Oscar G. Gómez-Duarte, MD, PhD, said in a news release.
Five more pediatric deaths due to the flu were logged by the CDC in the past week, bringing the total for pediatric flu deaths this season to 12. Nearly 21 per 100,000 children ages 4 and under are being hospitalized for the flu, which is double the rate for children ages 5-17. Last year at this time, fewer than 1 child under age 4 per 100,000 were being hospitalized for the flu.
RSV rates are also stunningly high.
“If we look at CDC data, the RSV hospitalization rate is 10 times higher than usual for this point in the season,” American Medical Association Vice President Andrea Garcia, JD, said in this week’s AMA podcast. “And 171 out of every 100,000 infants younger than 6 months were hospitalized with RSV for the week ending Nov. 12. That is more than double the RSV hospitalization rate for newborns last year and seven times the rate in 2018, which is the last complete season we saw before the pandemic.”
Dr. Gómez-Duarte said hospitals are admitting children with respiratory illnesses who had otherwise been healthy, and sometimes they are even seeing patients with more than one illness.
“Yes, some children are getting what we call coinfections, where they become infected with more than one virus at a time. In some instances, a child becomes initially infected with flu, begins to recover, and subsequently comes down with rhinovirus (a common cold virus), RSV, or any other respiratory virus,” he said. “These coinfections tend to be more severe than when the child just has one infection.”
A version of this article first appeared on Medscape.com.
There has been no ebb in the flurry of respiratory illnesses infecting America’s youngest children. More pediatric wards across the country are announcing crises as beds reach capacity, the pediatric death toll jumped significantly in the past week, and sometimes children are being infected with more than one virus at a time.
In Oregon, for example, the governor announced an official state of emergency to help hospitals deal with the surge of respiratory viruses. Doernbecher Children’s Hospital in Portland, which houses half of all pediatric ICU beds statewide, moved to “crisis mode” and said every pediatric ICU bed was full, Oregon Public Broadcasting reported.
Last month, pediatricians nationwide called for a similar emergency declaration from the federal government to help them respond to the wave of illnesses, which include influenza and respiratory syncytial virus (RSV).
“What’s concerning to us are not only the number of infections, but the severity of these infections, leading to a high number of emergency room visits and hospitalizations,” pediatric infectious disease expert Oscar G. Gómez-Duarte, MD, PhD, said in a news release.
Five more pediatric deaths due to the flu were logged by the CDC in the past week, bringing the total for pediatric flu deaths this season to 12. Nearly 21 per 100,000 children ages 4 and under are being hospitalized for the flu, which is double the rate for children ages 5-17. Last year at this time, fewer than 1 child under age 4 per 100,000 were being hospitalized for the flu.
RSV rates are also stunningly high.
“If we look at CDC data, the RSV hospitalization rate is 10 times higher than usual for this point in the season,” American Medical Association Vice President Andrea Garcia, JD, said in this week’s AMA podcast. “And 171 out of every 100,000 infants younger than 6 months were hospitalized with RSV for the week ending Nov. 12. That is more than double the RSV hospitalization rate for newborns last year and seven times the rate in 2018, which is the last complete season we saw before the pandemic.”
Dr. Gómez-Duarte said hospitals are admitting children with respiratory illnesses who had otherwise been healthy, and sometimes they are even seeing patients with more than one illness.
“Yes, some children are getting what we call coinfections, where they become infected with more than one virus at a time. In some instances, a child becomes initially infected with flu, begins to recover, and subsequently comes down with rhinovirus (a common cold virus), RSV, or any other respiratory virus,” he said. “These coinfections tend to be more severe than when the child just has one infection.”
A version of this article first appeared on Medscape.com.
Shorter fever prevention duration effective after cardiac arrest
a randomized trial shows.
“Since 2005, active fever prevention in comatose patients has been advocated by the guidelines for 72 hours after an out-of-hospital cardiac arrest,” Christian Hassager, MD, of the University of Copenhagen, told this news organization. “Our study is the first randomized trial ever on this subject – and it challenges the guidelines.”
At 90 days, a primary endpoint – a composite of death from any cause or hospital discharge with a high Cerebral Performance Category score – occurred in 32.4% of those in the 36-hour group and 33.6% of those in the 72-hour group; mortality was 29.5% versus 30.3%, respectively.
The study was published online in The New England Journal of Medicine. The results were also presented at the Resuscitation Science Symposium during the American Heart Association scientific sessions.
No significant differences
Assessment of the two device-based fever-prevention strategies for the duration was a predefined, additional randomly assigned open-label intervention in the Blood Pressure and Oxygenation Targets in Post Resuscitation Care (BOX) trial, which involved comatose adult patients who had been resuscitated after out-of-hospital cardiac arrest at two Danish cardiac arrest centers.
The main BOX analysis compared different primary strategies in these patients in a two-by-two factorial design: higher versus lower blood pressure targets and higher versus lower oxygenation targets. They found no difference between the various strategies in terms of death and discharge from hospital in a poor neurologic state. Those results were presented at the European Society of Cardiology Congress on Aug. 27, and simultaneously published in separate articles in The New England Journal of Medicine.
For this current analysis, a total of 789 comatose patients (mean age, 62; 80% men) received device-based temperature control targeting 36° C for 24 hours followed by 37° C for either 12 or 48 hours (total intervention times, 36 and 72 hours, respectively) or until the patient regained consciousness.
Patients were kept sedated and were receiving mechanical ventilation during the temperature control at 36° C, the authors note. Target core body temperature was controlled using commercially available surface cooling at one of the sites in 286 patients (Criticool and Allon, Belmont Medical Technologies) and using intravenous cooling in 503 patients at the other site (Thermogard XP, and Cool Line Catheter, Zoll).
Body temperature was maintained at 37° C with the same type of device that had been used for 36° C during the initial 24 hours. If the patient awakened, cooling was terminated.
Physicians in both groups were permitted to use non–device-based fever treatment (that is, for a body temperature > 37.5° C) with drugs such as paracetamol, by uncovering the patient’s body, or both, at the discretion of the treating physician. Ice packs or pads were not used.
The primary outcome was a composite of death from any cause or hospital discharge with a Cerebral Performance Category of 3 or 4 (range, 1 to 5, with higher scores indicating more severe disability) within 90 days after randomization.
Secondary outcomes at 90 days included death from any cause and the Montreal Cognitive Assessment score (range, 0 to 30, with higher scores indicating better cognitive ability).
A primary endpoint event occurred in 32.3% of patients in the 36-hour group and in 33.6% of those in the 72-hour group (hazard ratio, 0.99). Mortality was 29.5% in the 36-hour group and 30.3% in the 72-hour group.
The median Montreal Cognitive Assessment scores were 26 and 27, respectively. No significant between-group differences in the incidence of adverse events were observed.
The authors concluded that “active device-based fever prevention for 36 or 72 hours after cardiac arrest did not result in significantly different percentages of patients dying or having severe disability or coma.”
Dr. Hassager added, “We will continue with a new trial where we will randomize to treatment as usual or immediate wakeup call and no temperature intervention at all.”
Findings ‘very persuasive’
Intensivist Ken Parhar, MD, clinical associate professor, Critical Care Medicine at the University of Calgary (Alta.) and Alberta Health Services, Edmonton, and medical director, Cardiovascular Intensive Care Unit, commented on the study.
“The findings are very clear and very persuasive,” he said. “I think this should be incorporated into future guidelines, though it would be nice to see the trial repeated in another center.”
Dr. Parhar has kept comatose patients under temperature control for less than 72 hours, but mainly because those patients started to wake up. “This study provides clarity on the safety of that process – that we don’t have to unnecessarily keep somebody sedated just for an arbitrary timeline,” he said. “Beyond 36 hours, we need to continue to use our judgment.”
The study was supported by a grant from the Novo Nordisk Foundation, as was the work of one of the coauthors. Dr. Hassager’s work was funded by a grant from the Lundbeck Foundation; he also received an individual research grant from the Novo Nordisk Foundation, as well as honoraria from ABIOMED. No other disclosures were declared.
A version of this article first appeared on Medscape.com.
a randomized trial shows.
“Since 2005, active fever prevention in comatose patients has been advocated by the guidelines for 72 hours after an out-of-hospital cardiac arrest,” Christian Hassager, MD, of the University of Copenhagen, told this news organization. “Our study is the first randomized trial ever on this subject – and it challenges the guidelines.”
At 90 days, a primary endpoint – a composite of death from any cause or hospital discharge with a high Cerebral Performance Category score – occurred in 32.4% of those in the 36-hour group and 33.6% of those in the 72-hour group; mortality was 29.5% versus 30.3%, respectively.
The study was published online in The New England Journal of Medicine. The results were also presented at the Resuscitation Science Symposium during the American Heart Association scientific sessions.
No significant differences
Assessment of the two device-based fever-prevention strategies for the duration was a predefined, additional randomly assigned open-label intervention in the Blood Pressure and Oxygenation Targets in Post Resuscitation Care (BOX) trial, which involved comatose adult patients who had been resuscitated after out-of-hospital cardiac arrest at two Danish cardiac arrest centers.
The main BOX analysis compared different primary strategies in these patients in a two-by-two factorial design: higher versus lower blood pressure targets and higher versus lower oxygenation targets. They found no difference between the various strategies in terms of death and discharge from hospital in a poor neurologic state. Those results were presented at the European Society of Cardiology Congress on Aug. 27, and simultaneously published in separate articles in The New England Journal of Medicine.
For this current analysis, a total of 789 comatose patients (mean age, 62; 80% men) received device-based temperature control targeting 36° C for 24 hours followed by 37° C for either 12 or 48 hours (total intervention times, 36 and 72 hours, respectively) or until the patient regained consciousness.
Patients were kept sedated and were receiving mechanical ventilation during the temperature control at 36° C, the authors note. Target core body temperature was controlled using commercially available surface cooling at one of the sites in 286 patients (Criticool and Allon, Belmont Medical Technologies) and using intravenous cooling in 503 patients at the other site (Thermogard XP, and Cool Line Catheter, Zoll).
Body temperature was maintained at 37° C with the same type of device that had been used for 36° C during the initial 24 hours. If the patient awakened, cooling was terminated.
Physicians in both groups were permitted to use non–device-based fever treatment (that is, for a body temperature > 37.5° C) with drugs such as paracetamol, by uncovering the patient’s body, or both, at the discretion of the treating physician. Ice packs or pads were not used.
The primary outcome was a composite of death from any cause or hospital discharge with a Cerebral Performance Category of 3 or 4 (range, 1 to 5, with higher scores indicating more severe disability) within 90 days after randomization.
Secondary outcomes at 90 days included death from any cause and the Montreal Cognitive Assessment score (range, 0 to 30, with higher scores indicating better cognitive ability).
A primary endpoint event occurred in 32.3% of patients in the 36-hour group and in 33.6% of those in the 72-hour group (hazard ratio, 0.99). Mortality was 29.5% in the 36-hour group and 30.3% in the 72-hour group.
The median Montreal Cognitive Assessment scores were 26 and 27, respectively. No significant between-group differences in the incidence of adverse events were observed.
The authors concluded that “active device-based fever prevention for 36 or 72 hours after cardiac arrest did not result in significantly different percentages of patients dying or having severe disability or coma.”
Dr. Hassager added, “We will continue with a new trial where we will randomize to treatment as usual or immediate wakeup call and no temperature intervention at all.”
Findings ‘very persuasive’
Intensivist Ken Parhar, MD, clinical associate professor, Critical Care Medicine at the University of Calgary (Alta.) and Alberta Health Services, Edmonton, and medical director, Cardiovascular Intensive Care Unit, commented on the study.
“The findings are very clear and very persuasive,” he said. “I think this should be incorporated into future guidelines, though it would be nice to see the trial repeated in another center.”
Dr. Parhar has kept comatose patients under temperature control for less than 72 hours, but mainly because those patients started to wake up. “This study provides clarity on the safety of that process – that we don’t have to unnecessarily keep somebody sedated just for an arbitrary timeline,” he said. “Beyond 36 hours, we need to continue to use our judgment.”
The study was supported by a grant from the Novo Nordisk Foundation, as was the work of one of the coauthors. Dr. Hassager’s work was funded by a grant from the Lundbeck Foundation; he also received an individual research grant from the Novo Nordisk Foundation, as well as honoraria from ABIOMED. No other disclosures were declared.
A version of this article first appeared on Medscape.com.
a randomized trial shows.
“Since 2005, active fever prevention in comatose patients has been advocated by the guidelines for 72 hours after an out-of-hospital cardiac arrest,” Christian Hassager, MD, of the University of Copenhagen, told this news organization. “Our study is the first randomized trial ever on this subject – and it challenges the guidelines.”
At 90 days, a primary endpoint – a composite of death from any cause or hospital discharge with a high Cerebral Performance Category score – occurred in 32.4% of those in the 36-hour group and 33.6% of those in the 72-hour group; mortality was 29.5% versus 30.3%, respectively.
The study was published online in The New England Journal of Medicine. The results were also presented at the Resuscitation Science Symposium during the American Heart Association scientific sessions.
No significant differences
Assessment of the two device-based fever-prevention strategies for the duration was a predefined, additional randomly assigned open-label intervention in the Blood Pressure and Oxygenation Targets in Post Resuscitation Care (BOX) trial, which involved comatose adult patients who had been resuscitated after out-of-hospital cardiac arrest at two Danish cardiac arrest centers.
The main BOX analysis compared different primary strategies in these patients in a two-by-two factorial design: higher versus lower blood pressure targets and higher versus lower oxygenation targets. They found no difference between the various strategies in terms of death and discharge from hospital in a poor neurologic state. Those results were presented at the European Society of Cardiology Congress on Aug. 27, and simultaneously published in separate articles in The New England Journal of Medicine.
For this current analysis, a total of 789 comatose patients (mean age, 62; 80% men) received device-based temperature control targeting 36° C for 24 hours followed by 37° C for either 12 or 48 hours (total intervention times, 36 and 72 hours, respectively) or until the patient regained consciousness.
Patients were kept sedated and were receiving mechanical ventilation during the temperature control at 36° C, the authors note. Target core body temperature was controlled using commercially available surface cooling at one of the sites in 286 patients (Criticool and Allon, Belmont Medical Technologies) and using intravenous cooling in 503 patients at the other site (Thermogard XP, and Cool Line Catheter, Zoll).
Body temperature was maintained at 37° C with the same type of device that had been used for 36° C during the initial 24 hours. If the patient awakened, cooling was terminated.
Physicians in both groups were permitted to use non–device-based fever treatment (that is, for a body temperature > 37.5° C) with drugs such as paracetamol, by uncovering the patient’s body, or both, at the discretion of the treating physician. Ice packs or pads were not used.
The primary outcome was a composite of death from any cause or hospital discharge with a Cerebral Performance Category of 3 or 4 (range, 1 to 5, with higher scores indicating more severe disability) within 90 days after randomization.
Secondary outcomes at 90 days included death from any cause and the Montreal Cognitive Assessment score (range, 0 to 30, with higher scores indicating better cognitive ability).
A primary endpoint event occurred in 32.3% of patients in the 36-hour group and in 33.6% of those in the 72-hour group (hazard ratio, 0.99). Mortality was 29.5% in the 36-hour group and 30.3% in the 72-hour group.
The median Montreal Cognitive Assessment scores were 26 and 27, respectively. No significant between-group differences in the incidence of adverse events were observed.
The authors concluded that “active device-based fever prevention for 36 or 72 hours after cardiac arrest did not result in significantly different percentages of patients dying or having severe disability or coma.”
Dr. Hassager added, “We will continue with a new trial where we will randomize to treatment as usual or immediate wakeup call and no temperature intervention at all.”
Findings ‘very persuasive’
Intensivist Ken Parhar, MD, clinical associate professor, Critical Care Medicine at the University of Calgary (Alta.) and Alberta Health Services, Edmonton, and medical director, Cardiovascular Intensive Care Unit, commented on the study.
“The findings are very clear and very persuasive,” he said. “I think this should be incorporated into future guidelines, though it would be nice to see the trial repeated in another center.”
Dr. Parhar has kept comatose patients under temperature control for less than 72 hours, but mainly because those patients started to wake up. “This study provides clarity on the safety of that process – that we don’t have to unnecessarily keep somebody sedated just for an arbitrary timeline,” he said. “Beyond 36 hours, we need to continue to use our judgment.”
The study was supported by a grant from the Novo Nordisk Foundation, as was the work of one of the coauthors. Dr. Hassager’s work was funded by a grant from the Lundbeck Foundation; he also received an individual research grant from the Novo Nordisk Foundation, as well as honoraria from ABIOMED. No other disclosures were declared.
A version of this article first appeared on Medscape.com.
FROM NEJM
Study supports banning probiotics from the ICU
NASHVILLE, TENN. – Supported by several cases series, according to new findings presented at the annual meeting of the American College of Chest Physicians (CHEST).
According to data presented by Scott Mayer, MD, chief resident at HealthONE Denver, which is part of the HCA Healthcare chain of hospitals, the risk is increased by any probiotic exposure. However, the risk is particularly acute for powdered formulations, presumably because powder more easily disseminates to contaminate central venous catheters.
“We think that probiotics should be eliminated entirely from the ICU. If not, we encourage eliminating the powder formulations,” said Dr. Mayer, who led the study.
The data linking probiotics to ICU bacteremia were drawn from 23,533 ICU admissions over a 5-year period in the HCA hospital database. Bacteremia proven to be probiotic-related was uncommon (0.37%), but the consequences were serious.
For those with probiotic-related bacteremia, the mortality rate was 25.6% or essentially twofold greater than the 13.5% mortality rate among those without probiotic bacteremia. An odds ratio drawn from a regression analysis confirmed a significant difference (OR, 2.23; 95% confidence interval, 1.30-3.71; P < .01).
“The absolute risk of mortality is modest but not insignificant,” said Dr. Mayer. This suggests one probiotic-related mortality for about every 200 patients taking a probiotic in the ICU.
These deaths occur without any clear compensatory benefit from taking probiotics, according to Dr. Mayer. There is a long list of potential benefits from probiotics that might be relevant to patients in the ICU, particularly prophylaxis for Clostridioides difficile infection, but also including a variety of gastrointestinal disorders, such as irritable bowel syndrome; however, none of these are firmly established in general, and particularly for patients in the ICU.
“The American College of Gastroenterology currently recommends against probiotics for the prevention of C. diff.,” Dr. Mayer said. Although the American Gastroenterological Association has issued a “conditional recommendation” for prevention of C. diff. infection with probiotics, Dr. Mayer pointed out this is qualified by a “low quality of evidence” and it is not specific to the ICU setting.
“The evidence for benefit is weak or nonexistent, but the risks are real,” Dr. Mayer said.
To confirm that probiotic-associated ICU bacteremias in the HCA hospital database were, in fact, related to probiotics being taken by patients at time of admission, Dr. Mayer evaluated the record of each of the 86 patients with probiotic bacteremia–associated mortality.
“I identified the organism that grew from the blood cultures to confirm that it was contained in the probiotic the patient was taking,” explained Dr. Mayer, who said this information was available in the electronic medical records.
The risk of probiotic-associated bacteremia in ICU patients was consistent with a series of case series that prompted the study. Dr. Mayer explained that he became interested when he encountered patients on his ICU rounds who were taking probiotics. He knew very little about these agents and explored the medical literature to see what evidence was available.
“I found several case reports of ICU patients with probiotic-associated infections, several of which were suspected of being associated with contamination of the central lines,” Dr. Mayer said. In one case, the patient was not taking a probiotic, but a patient in an adjacent bed was receiving a powdered probiotic that was implicated. This prompted suspicion that the cause was central-line contamination.
This was evaluated in the HCA ICU database and also found to be a significant risk. Among the 67 patients in whom a capsule or tablet was used, the rate of probiotic-associated bacteremia was 0.33%. For those in which the probiotic was a powdered formulation, the rate was 0.76%, a significant difference (P < .01).
Dr. Mayer acknowledged that these data do not rule out all potential benefits from probiotics in the ICU. He believes an obstacle to proving benefit has been the heterogeneity of available products, which are likely to be relevant to any therapeutic role, including prevention of C. diff. infection.
“There are now a large number of products available, and they contain a large variety of strains of organisms, so this has been a difficult area to study,” he said. However, he maintains it is prudent at this point to avoid probiotics in the ICU because the risks are not confined to the patient making this choice.
“My concern is not just the lack of evidence of benefit relative to the risk for the patient but the potential for probiotics in the ICU to place other patients at risk,” Dr. Mayer said.
Others have also noted the potential benefits of probiotics in the ICU, but the promise remains elusive. In a 2018 review article published in the Journal of Emergency and Critical Care Medicine, the authors evaluated a series of potential applications of probiotics in critically ill patients. These included treatment of ventilator-associated pneumonia (VAP), catheter-associated urinary tract infections (CAUTI), and surgical-site infections (SSI). For each, the data were negative or inconclusive.
Over the 4 years that have passed since the review was published, several trials have further explored the potential benefits of probiotics in the ICU but none have changed this basic conclusion. For example, a 2021 multinational trial, published in The Lancet, randomized more than 2,600 patients to probiotics or placebo and showed no effect on VAP incidence (21.9% vs. 21.3%).
The lead author of the 2018 review, Heather A. Vitko, PhD, an associate professor in the department of acute and tertiary care, University of Pittsburgh School of Nursing, also emphasized that the potential for benefit cannot be considered without the potential for risk. She, like Dr. Mayer, cited the case studies implicating probiotics in systemic infections.
For administration, probiotic capsules or sachets “often need to be opened for administration through a feeding tube,” she noted. The risk of contamination comes from both the air and contaminated hands, the latter of which “can cause a translocation to a central line catheter where the microbes have direct entry into the systemic circulation.”
She did not call for a ban of probiotics in the ICU, but she did recommend “a precautionary approach,” encouraging clinicians to “distinguish between reality [of what has been proven] and what is presented in the marketing of antibiotics.”
Dr. Mayer and Dr. Vitko have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
NASHVILLE, TENN. – Supported by several cases series, according to new findings presented at the annual meeting of the American College of Chest Physicians (CHEST).
According to data presented by Scott Mayer, MD, chief resident at HealthONE Denver, which is part of the HCA Healthcare chain of hospitals, the risk is increased by any probiotic exposure. However, the risk is particularly acute for powdered formulations, presumably because powder more easily disseminates to contaminate central venous catheters.
“We think that probiotics should be eliminated entirely from the ICU. If not, we encourage eliminating the powder formulations,” said Dr. Mayer, who led the study.
The data linking probiotics to ICU bacteremia were drawn from 23,533 ICU admissions over a 5-year period in the HCA hospital database. Bacteremia proven to be probiotic-related was uncommon (0.37%), but the consequences were serious.
For those with probiotic-related bacteremia, the mortality rate was 25.6% or essentially twofold greater than the 13.5% mortality rate among those without probiotic bacteremia. An odds ratio drawn from a regression analysis confirmed a significant difference (OR, 2.23; 95% confidence interval, 1.30-3.71; P < .01).
“The absolute risk of mortality is modest but not insignificant,” said Dr. Mayer. This suggests one probiotic-related mortality for about every 200 patients taking a probiotic in the ICU.
These deaths occur without any clear compensatory benefit from taking probiotics, according to Dr. Mayer. There is a long list of potential benefits from probiotics that might be relevant to patients in the ICU, particularly prophylaxis for Clostridioides difficile infection, but also including a variety of gastrointestinal disorders, such as irritable bowel syndrome; however, none of these are firmly established in general, and particularly for patients in the ICU.
“The American College of Gastroenterology currently recommends against probiotics for the prevention of C. diff.,” Dr. Mayer said. Although the American Gastroenterological Association has issued a “conditional recommendation” for prevention of C. diff. infection with probiotics, Dr. Mayer pointed out this is qualified by a “low quality of evidence” and it is not specific to the ICU setting.
“The evidence for benefit is weak or nonexistent, but the risks are real,” Dr. Mayer said.
To confirm that probiotic-associated ICU bacteremias in the HCA hospital database were, in fact, related to probiotics being taken by patients at time of admission, Dr. Mayer evaluated the record of each of the 86 patients with probiotic bacteremia–associated mortality.
“I identified the organism that grew from the blood cultures to confirm that it was contained in the probiotic the patient was taking,” explained Dr. Mayer, who said this information was available in the electronic medical records.
The risk of probiotic-associated bacteremia in ICU patients was consistent with a series of case series that prompted the study. Dr. Mayer explained that he became interested when he encountered patients on his ICU rounds who were taking probiotics. He knew very little about these agents and explored the medical literature to see what evidence was available.
“I found several case reports of ICU patients with probiotic-associated infections, several of which were suspected of being associated with contamination of the central lines,” Dr. Mayer said. In one case, the patient was not taking a probiotic, but a patient in an adjacent bed was receiving a powdered probiotic that was implicated. This prompted suspicion that the cause was central-line contamination.
This was evaluated in the HCA ICU database and also found to be a significant risk. Among the 67 patients in whom a capsule or tablet was used, the rate of probiotic-associated bacteremia was 0.33%. For those in which the probiotic was a powdered formulation, the rate was 0.76%, a significant difference (P < .01).
Dr. Mayer acknowledged that these data do not rule out all potential benefits from probiotics in the ICU. He believes an obstacle to proving benefit has been the heterogeneity of available products, which are likely to be relevant to any therapeutic role, including prevention of C. diff. infection.
“There are now a large number of products available, and they contain a large variety of strains of organisms, so this has been a difficult area to study,” he said. However, he maintains it is prudent at this point to avoid probiotics in the ICU because the risks are not confined to the patient making this choice.
“My concern is not just the lack of evidence of benefit relative to the risk for the patient but the potential for probiotics in the ICU to place other patients at risk,” Dr. Mayer said.
Others have also noted the potential benefits of probiotics in the ICU, but the promise remains elusive. In a 2018 review article published in the Journal of Emergency and Critical Care Medicine, the authors evaluated a series of potential applications of probiotics in critically ill patients. These included treatment of ventilator-associated pneumonia (VAP), catheter-associated urinary tract infections (CAUTI), and surgical-site infections (SSI). For each, the data were negative or inconclusive.
Over the 4 years that have passed since the review was published, several trials have further explored the potential benefits of probiotics in the ICU but none have changed this basic conclusion. For example, a 2021 multinational trial, published in The Lancet, randomized more than 2,600 patients to probiotics or placebo and showed no effect on VAP incidence (21.9% vs. 21.3%).
The lead author of the 2018 review, Heather A. Vitko, PhD, an associate professor in the department of acute and tertiary care, University of Pittsburgh School of Nursing, also emphasized that the potential for benefit cannot be considered without the potential for risk. She, like Dr. Mayer, cited the case studies implicating probiotics in systemic infections.
For administration, probiotic capsules or sachets “often need to be opened for administration through a feeding tube,” she noted. The risk of contamination comes from both the air and contaminated hands, the latter of which “can cause a translocation to a central line catheter where the microbes have direct entry into the systemic circulation.”
She did not call for a ban of probiotics in the ICU, but she did recommend “a precautionary approach,” encouraging clinicians to “distinguish between reality [of what has been proven] and what is presented in the marketing of antibiotics.”
Dr. Mayer and Dr. Vitko have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
NASHVILLE, TENN. – Supported by several cases series, according to new findings presented at the annual meeting of the American College of Chest Physicians (CHEST).
According to data presented by Scott Mayer, MD, chief resident at HealthONE Denver, which is part of the HCA Healthcare chain of hospitals, the risk is increased by any probiotic exposure. However, the risk is particularly acute for powdered formulations, presumably because powder more easily disseminates to contaminate central venous catheters.
“We think that probiotics should be eliminated entirely from the ICU. If not, we encourage eliminating the powder formulations,” said Dr. Mayer, who led the study.
The data linking probiotics to ICU bacteremia were drawn from 23,533 ICU admissions over a 5-year period in the HCA hospital database. Bacteremia proven to be probiotic-related was uncommon (0.37%), but the consequences were serious.
For those with probiotic-related bacteremia, the mortality rate was 25.6% or essentially twofold greater than the 13.5% mortality rate among those without probiotic bacteremia. An odds ratio drawn from a regression analysis confirmed a significant difference (OR, 2.23; 95% confidence interval, 1.30-3.71; P < .01).
“The absolute risk of mortality is modest but not insignificant,” said Dr. Mayer. This suggests one probiotic-related mortality for about every 200 patients taking a probiotic in the ICU.
These deaths occur without any clear compensatory benefit from taking probiotics, according to Dr. Mayer. There is a long list of potential benefits from probiotics that might be relevant to patients in the ICU, particularly prophylaxis for Clostridioides difficile infection, but also including a variety of gastrointestinal disorders, such as irritable bowel syndrome; however, none of these are firmly established in general, and particularly for patients in the ICU.
“The American College of Gastroenterology currently recommends against probiotics for the prevention of C. diff.,” Dr. Mayer said. Although the American Gastroenterological Association has issued a “conditional recommendation” for prevention of C. diff. infection with probiotics, Dr. Mayer pointed out this is qualified by a “low quality of evidence” and it is not specific to the ICU setting.
“The evidence for benefit is weak or nonexistent, but the risks are real,” Dr. Mayer said.
To confirm that probiotic-associated ICU bacteremias in the HCA hospital database were, in fact, related to probiotics being taken by patients at time of admission, Dr. Mayer evaluated the record of each of the 86 patients with probiotic bacteremia–associated mortality.
“I identified the organism that grew from the blood cultures to confirm that it was contained in the probiotic the patient was taking,” explained Dr. Mayer, who said this information was available in the electronic medical records.
The risk of probiotic-associated bacteremia in ICU patients was consistent with a series of case series that prompted the study. Dr. Mayer explained that he became interested when he encountered patients on his ICU rounds who were taking probiotics. He knew very little about these agents and explored the medical literature to see what evidence was available.
“I found several case reports of ICU patients with probiotic-associated infections, several of which were suspected of being associated with contamination of the central lines,” Dr. Mayer said. In one case, the patient was not taking a probiotic, but a patient in an adjacent bed was receiving a powdered probiotic that was implicated. This prompted suspicion that the cause was central-line contamination.
This was evaluated in the HCA ICU database and also found to be a significant risk. Among the 67 patients in whom a capsule or tablet was used, the rate of probiotic-associated bacteremia was 0.33%. For those in which the probiotic was a powdered formulation, the rate was 0.76%, a significant difference (P < .01).
Dr. Mayer acknowledged that these data do not rule out all potential benefits from probiotics in the ICU. He believes an obstacle to proving benefit has been the heterogeneity of available products, which are likely to be relevant to any therapeutic role, including prevention of C. diff. infection.
“There are now a large number of products available, and they contain a large variety of strains of organisms, so this has been a difficult area to study,” he said. However, he maintains it is prudent at this point to avoid probiotics in the ICU because the risks are not confined to the patient making this choice.
“My concern is not just the lack of evidence of benefit relative to the risk for the patient but the potential for probiotics in the ICU to place other patients at risk,” Dr. Mayer said.
Others have also noted the potential benefits of probiotics in the ICU, but the promise remains elusive. In a 2018 review article published in the Journal of Emergency and Critical Care Medicine, the authors evaluated a series of potential applications of probiotics in critically ill patients. These included treatment of ventilator-associated pneumonia (VAP), catheter-associated urinary tract infections (CAUTI), and surgical-site infections (SSI). For each, the data were negative or inconclusive.
Over the 4 years that have passed since the review was published, several trials have further explored the potential benefits of probiotics in the ICU but none have changed this basic conclusion. For example, a 2021 multinational trial, published in The Lancet, randomized more than 2,600 patients to probiotics or placebo and showed no effect on VAP incidence (21.9% vs. 21.3%).
The lead author of the 2018 review, Heather A. Vitko, PhD, an associate professor in the department of acute and tertiary care, University of Pittsburgh School of Nursing, also emphasized that the potential for benefit cannot be considered without the potential for risk. She, like Dr. Mayer, cited the case studies implicating probiotics in systemic infections.
For administration, probiotic capsules or sachets “often need to be opened for administration through a feeding tube,” she noted. The risk of contamination comes from both the air and contaminated hands, the latter of which “can cause a translocation to a central line catheter where the microbes have direct entry into the systemic circulation.”
She did not call for a ban of probiotics in the ICU, but she did recommend “a precautionary approach,” encouraging clinicians to “distinguish between reality [of what has been proven] and what is presented in the marketing of antibiotics.”
Dr. Mayer and Dr. Vitko have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CHEST 2022
AAP issues guidelines to combat rise in respiratory illness
Updated guidance from the group outlines measures to optimize resources to manage a surge of patients filling hospital beds, emergency departments, and physicians’ practices.
A separate document from the AAP endorses giving extra doses of palivizumab, a monoclonal antibody used to prevent severe infection in infants at high risk of respiratory syncytial virus (RSV), as long as the illness is prevalent in the community.
Upticks in rates of RSV and influenza, along with a crisis in children’s mental health, prompted the AAP and the Children’s Hospital Association to petition the Biden administration on Nov. 14 to declare an emergency. Such a move would free up extra funding and waivers to allow physicians and hospitals to pool resources, the organizations said.
Despite those challenges, the AAP stressed in its new guidance that routine care, such as immunizations and chronic disease management, “cannot be neglected.”
Shifting resources
Officials at some children’s hospitals said that they have already implemented many of the AAP’s recommended measures for providing care during a surge, such as cross-training staff who usually treat adults, expanding telehealth and urgent care, and optimizing the use of ancillary care spaces.
“A lot of this is just reinforcing the things that I think children’s hospitals have been doing,” Lindsay Ragsdale, MD, chief medical officer for Kentucky Children’s Hospital, Lexington, said. “Can we shift adults around? Can we use an adult unit? Can we use an occupied space creatively? We’re really thinking outside the box.”
Andrew Pavia, MD, chief of the division of pediatric infectious diseases at University of Utah Health, Salt Lake City, said large children’s hospitals have been actively sharing practices for handling a surge through various channels, but the new guidance could be a useful “checklist” for small hospitals and physician practices that lack well-developed plans.
The AAP’s suggestions for pediatricians in outpatient settings include stocking up on personal protective equipment, using social media and office staff to increase communication with families, and keeping abreast of wait times at local emergency departments.
Addressing a subset of kids
In updated guidance for palivizumab, the AAP noted that earlier-than-usual circulation of RSV prompted pediatricians in some areas to begin administering the drug in the summer and early fall.
Palivizumab is typically given in five consecutive monthly intramuscular injections during RSV season, starting in November. Eligible infants and young children include those born prematurely or who have conditions such as chronic lung disease, hemodynamically significant congenital heart disease, or a suppressed immune system.
The AAP said it supports giving extra doses if RSV activity “persists at high levels in a given region through the fall and winter.” Published studies are sparse but contain “no evidence of increased frequency or severity of adverse events with later doses in a five-dose series nor with doses beyond five doses,” the group added.
The guidance may encourage payers to pick up the tab for extra doses, which are priced at more than $1,800 for cash customers, Dr. Pavia said. However, that recommendation addresses “a pretty small part of the problem overall because the injections are used for a very small subset of kids who are at the highest risk, and more than 80% of hospitalizations for RSV are among healthy kids,” he added.
Dr. Ragsdale and Dr. Pavia have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Updated guidance from the group outlines measures to optimize resources to manage a surge of patients filling hospital beds, emergency departments, and physicians’ practices.
A separate document from the AAP endorses giving extra doses of palivizumab, a monoclonal antibody used to prevent severe infection in infants at high risk of respiratory syncytial virus (RSV), as long as the illness is prevalent in the community.
Upticks in rates of RSV and influenza, along with a crisis in children’s mental health, prompted the AAP and the Children’s Hospital Association to petition the Biden administration on Nov. 14 to declare an emergency. Such a move would free up extra funding and waivers to allow physicians and hospitals to pool resources, the organizations said.
Despite those challenges, the AAP stressed in its new guidance that routine care, such as immunizations and chronic disease management, “cannot be neglected.”
Shifting resources
Officials at some children’s hospitals said that they have already implemented many of the AAP’s recommended measures for providing care during a surge, such as cross-training staff who usually treat adults, expanding telehealth and urgent care, and optimizing the use of ancillary care spaces.
“A lot of this is just reinforcing the things that I think children’s hospitals have been doing,” Lindsay Ragsdale, MD, chief medical officer for Kentucky Children’s Hospital, Lexington, said. “Can we shift adults around? Can we use an adult unit? Can we use an occupied space creatively? We’re really thinking outside the box.”
Andrew Pavia, MD, chief of the division of pediatric infectious diseases at University of Utah Health, Salt Lake City, said large children’s hospitals have been actively sharing practices for handling a surge through various channels, but the new guidance could be a useful “checklist” for small hospitals and physician practices that lack well-developed plans.
The AAP’s suggestions for pediatricians in outpatient settings include stocking up on personal protective equipment, using social media and office staff to increase communication with families, and keeping abreast of wait times at local emergency departments.
Addressing a subset of kids
In updated guidance for palivizumab, the AAP noted that earlier-than-usual circulation of RSV prompted pediatricians in some areas to begin administering the drug in the summer and early fall.
Palivizumab is typically given in five consecutive monthly intramuscular injections during RSV season, starting in November. Eligible infants and young children include those born prematurely or who have conditions such as chronic lung disease, hemodynamically significant congenital heart disease, or a suppressed immune system.
The AAP said it supports giving extra doses if RSV activity “persists at high levels in a given region through the fall and winter.” Published studies are sparse but contain “no evidence of increased frequency or severity of adverse events with later doses in a five-dose series nor with doses beyond five doses,” the group added.
The guidance may encourage payers to pick up the tab for extra doses, which are priced at more than $1,800 for cash customers, Dr. Pavia said. However, that recommendation addresses “a pretty small part of the problem overall because the injections are used for a very small subset of kids who are at the highest risk, and more than 80% of hospitalizations for RSV are among healthy kids,” he added.
Dr. Ragsdale and Dr. Pavia have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Updated guidance from the group outlines measures to optimize resources to manage a surge of patients filling hospital beds, emergency departments, and physicians’ practices.
A separate document from the AAP endorses giving extra doses of palivizumab, a monoclonal antibody used to prevent severe infection in infants at high risk of respiratory syncytial virus (RSV), as long as the illness is prevalent in the community.
Upticks in rates of RSV and influenza, along with a crisis in children’s mental health, prompted the AAP and the Children’s Hospital Association to petition the Biden administration on Nov. 14 to declare an emergency. Such a move would free up extra funding and waivers to allow physicians and hospitals to pool resources, the organizations said.
Despite those challenges, the AAP stressed in its new guidance that routine care, such as immunizations and chronic disease management, “cannot be neglected.”
Shifting resources
Officials at some children’s hospitals said that they have already implemented many of the AAP’s recommended measures for providing care during a surge, such as cross-training staff who usually treat adults, expanding telehealth and urgent care, and optimizing the use of ancillary care spaces.
“A lot of this is just reinforcing the things that I think children’s hospitals have been doing,” Lindsay Ragsdale, MD, chief medical officer for Kentucky Children’s Hospital, Lexington, said. “Can we shift adults around? Can we use an adult unit? Can we use an occupied space creatively? We’re really thinking outside the box.”
Andrew Pavia, MD, chief of the division of pediatric infectious diseases at University of Utah Health, Salt Lake City, said large children’s hospitals have been actively sharing practices for handling a surge through various channels, but the new guidance could be a useful “checklist” for small hospitals and physician practices that lack well-developed plans.
The AAP’s suggestions for pediatricians in outpatient settings include stocking up on personal protective equipment, using social media and office staff to increase communication with families, and keeping abreast of wait times at local emergency departments.
Addressing a subset of kids
In updated guidance for palivizumab, the AAP noted that earlier-than-usual circulation of RSV prompted pediatricians in some areas to begin administering the drug in the summer and early fall.
Palivizumab is typically given in five consecutive monthly intramuscular injections during RSV season, starting in November. Eligible infants and young children include those born prematurely or who have conditions such as chronic lung disease, hemodynamically significant congenital heart disease, or a suppressed immune system.
The AAP said it supports giving extra doses if RSV activity “persists at high levels in a given region through the fall and winter.” Published studies are sparse but contain “no evidence of increased frequency or severity of adverse events with later doses in a five-dose series nor with doses beyond five doses,” the group added.
The guidance may encourage payers to pick up the tab for extra doses, which are priced at more than $1,800 for cash customers, Dr. Pavia said. However, that recommendation addresses “a pretty small part of the problem overall because the injections are used for a very small subset of kids who are at the highest risk, and more than 80% of hospitalizations for RSV are among healthy kids,” he added.
Dr. Ragsdale and Dr. Pavia have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A plane crash interrupts a doctor’s vacation
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 new series telling these stories.
When the plane crashed, I was asleep. I had arrived the evening before with my wife and three sons at a house on Kezar Lake on the Maine–New Hampshire border. I jumped out of bed and ran downstairs. My kids had been watching a float plane circling and gliding along the lake. It had crashed into the water and flipped upside down. My oldest brother-in-law jumped into his ski boat and we sped out to the scene.
All we can see are the plane’s pontoons. The rest is underwater. A woman has already surfaced, screaming. I dive in.
I find the woman’s husband and 3-year-old son struggling to get free from the plane through the smashed windshield. They manage to get to the surface. The pilot is dead, impaled through the chest by the left wing strut.
The big problem: A little girl, whom I would learn later is named Lauren, remained trapped. The water is murky but I can see her, a 5- or 6-year-old girl with this long hair, strapped in upside down and unconscious.
The mom and I dive down over and over, pulling and ripping at the door. We cannot get it open. Finally, I’m able to bend the door open enough where I can reach in, but I can’t undo the seatbelt. In my mind, I’m debating, should I try and go through the front windshield? I’m getting really tired, I can tell there’s fuel in the water, and I don’t want to drown in the plane. So I pop up to the surface and yell, “Does anyone have a knife?”
My brother-in-law shoots back to shore in the boat, screaming, “Get a knife!” My niece gets in the boat with one. I’m standing on the pontoon, and my niece is in the front of the boat calling, “Uncle Todd! Uncle Todd!” and she throws the knife. It goes way over my head. I can’t even jump for it, it’s so high.
I have to get the knife. So, I dive into the water to try and find it. Somehow, the black knife has landed on the white wing, 4 or 5 feet under the water. Pure luck. It could have sunk down a hundred feet into the lake. I grab the knife and hand it to the mom, Beth. She’s able to cut the seatbelt, and we both pull Lauren to the surface.
I lay her out on the pontoon. She has no pulse and her pupils are fixed and dilated. Her mom is yelling, “She’s dead, isn’t she?” I start CPR. My skin and eyes are burning from the airplane fuel in the water. I get her breathing, and her heart comes back very quickly. Lauren starts to vomit and I’m trying to keep her airway clear. She’s breathing spontaneously and she has a pulse, so I decide it’s time to move her to shore.
We pull the boat up to the dock and Lauren’s now having anoxic seizures. Her brain has been without oxygen, and now she’s getting perfused again. We get her to shore and lay her on the lawn. I’m still doing mouth-to-mouth, but she’s seizing like crazy, and I don’t have any way to control that. Beth is crying and wants to hold her daughter gently while I’m working.
Someone had called 911, and finally this dude shows up with an ambulance, and it’s like something out of World War II. All he has is an oxygen tank, but the mask is old and cracked. It’s too big for Lauren, but it sort of fits me, so I’m sucking in oxygen and blowing it into the girl’s mouth. I’m doing whatever I can, but I don’t have an IV to start. I have no fluids. I got nothing.
As it happens, I’d done my emergency medicine training at Maine Medical Center, so I tell someone to call them and get a Life Flight chopper. We have to drive somewhere where the chopper can land, so we take the ambulance to the parking lot of the closest store called the Wicked Good Store. That’s a common thing in Maine. Everything is “wicked good.”
The whole town is there by that point. The chopper arrives. The ambulance doors pop open and a woman says, “Todd?” And I say, “Heather?”
Heather is an emergency flight nurse whom I’d trained with many years ago. There’s immediate trust. She has all the right equipment. We put in breathing tubes and IVs. We stop Lauren from seizing. The kid is soon stable.
There is only one extra seat in the chopper, so I tell Beth to go. They take off.
Suddenly, I begin to doubt my decision. Lauren had been underwater for 15 minutes at minimum. I know how long that is. Did I do the right thing? Did I resuscitate a brain-dead child? I didn’t think about it at the time, but if that patient had come to me in the emergency department, I’m honestly not sure what I would have done.
So, I go home. And I don’t get a call. The FAA and sheriff arrive to take statements from us. I don’t hear from anyone.
The next day I start calling. No one will tell me anything, so I finally get to one of the pediatric ICU attendings who had trained me. He says Lauren literally woke up and said, “I have to go pee.” And that was it. She was 100% normal. I couldn’t believe it.
Here’s a theory: In kids, there’s something called the glottic reflex. I think her glottic reflex went off as soon as she hit the water, which basically closed her airway. So when she passed out, she could never get enough water in her lungs and still had enough air in there to keep her alive. Later, I got a call from her uncle. He could barely get the words out because he was in tears. He said Lauren was doing beautifully.
Three days later, I drove to Lauren’s house with my wife and kids. I had her read to me. I watched her play on the jungle gym for motor function. All sorts of stuff. She was totally normal.
Beth told us that the night before the accident, her mother had given the women in her family what she called a “miracle bracelet,” a bracelet that is supposed to give you one miracle in your life. Beth said she had the bracelet on her wrist the day of the accident, and now it’s gone. “Saving Lauren’s life was my miracle,” she said.
Funny thing: For 20 years, I ran all the EMS, police, fire, ambulance, in Boulder, Colo., where I live. I wrote all the protocols, and I would never advise any of my paramedics to dive into jet fuel to save someone. That was risky. But at the time, it was totally automatic. I think it taught me not to give up in certain situations, because you really don’t know.
Dr. Dorfman is an emergency medicine physician in Boulder, Colo., and medical director at Cedalion Health.
A version of this article first 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 new series telling these stories.
When the plane crashed, I was asleep. I had arrived the evening before with my wife and three sons at a house on Kezar Lake on the Maine–New Hampshire border. I jumped out of bed and ran downstairs. My kids had been watching a float plane circling and gliding along the lake. It had crashed into the water and flipped upside down. My oldest brother-in-law jumped into his ski boat and we sped out to the scene.
All we can see are the plane’s pontoons. The rest is underwater. A woman has already surfaced, screaming. I dive in.
I find the woman’s husband and 3-year-old son struggling to get free from the plane through the smashed windshield. They manage to get to the surface. The pilot is dead, impaled through the chest by the left wing strut.
The big problem: A little girl, whom I would learn later is named Lauren, remained trapped. The water is murky but I can see her, a 5- or 6-year-old girl with this long hair, strapped in upside down and unconscious.
The mom and I dive down over and over, pulling and ripping at the door. We cannot get it open. Finally, I’m able to bend the door open enough where I can reach in, but I can’t undo the seatbelt. In my mind, I’m debating, should I try and go through the front windshield? I’m getting really tired, I can tell there’s fuel in the water, and I don’t want to drown in the plane. So I pop up to the surface and yell, “Does anyone have a knife?”
My brother-in-law shoots back to shore in the boat, screaming, “Get a knife!” My niece gets in the boat with one. I’m standing on the pontoon, and my niece is in the front of the boat calling, “Uncle Todd! Uncle Todd!” and she throws the knife. It goes way over my head. I can’t even jump for it, it’s so high.
I have to get the knife. So, I dive into the water to try and find it. Somehow, the black knife has landed on the white wing, 4 or 5 feet under the water. Pure luck. It could have sunk down a hundred feet into the lake. I grab the knife and hand it to the mom, Beth. She’s able to cut the seatbelt, and we both pull Lauren to the surface.
I lay her out on the pontoon. She has no pulse and her pupils are fixed and dilated. Her mom is yelling, “She’s dead, isn’t she?” I start CPR. My skin and eyes are burning from the airplane fuel in the water. I get her breathing, and her heart comes back very quickly. Lauren starts to vomit and I’m trying to keep her airway clear. She’s breathing spontaneously and she has a pulse, so I decide it’s time to move her to shore.
We pull the boat up to the dock and Lauren’s now having anoxic seizures. Her brain has been without oxygen, and now she’s getting perfused again. We get her to shore and lay her on the lawn. I’m still doing mouth-to-mouth, but she’s seizing like crazy, and I don’t have any way to control that. Beth is crying and wants to hold her daughter gently while I’m working.
Someone had called 911, and finally this dude shows up with an ambulance, and it’s like something out of World War II. All he has is an oxygen tank, but the mask is old and cracked. It’s too big for Lauren, but it sort of fits me, so I’m sucking in oxygen and blowing it into the girl’s mouth. I’m doing whatever I can, but I don’t have an IV to start. I have no fluids. I got nothing.
As it happens, I’d done my emergency medicine training at Maine Medical Center, so I tell someone to call them and get a Life Flight chopper. We have to drive somewhere where the chopper can land, so we take the ambulance to the parking lot of the closest store called the Wicked Good Store. That’s a common thing in Maine. Everything is “wicked good.”
The whole town is there by that point. The chopper arrives. The ambulance doors pop open and a woman says, “Todd?” And I say, “Heather?”
Heather is an emergency flight nurse whom I’d trained with many years ago. There’s immediate trust. She has all the right equipment. We put in breathing tubes and IVs. We stop Lauren from seizing. The kid is soon stable.
There is only one extra seat in the chopper, so I tell Beth to go. They take off.
Suddenly, I begin to doubt my decision. Lauren had been underwater for 15 minutes at minimum. I know how long that is. Did I do the right thing? Did I resuscitate a brain-dead child? I didn’t think about it at the time, but if that patient had come to me in the emergency department, I’m honestly not sure what I would have done.
So, I go home. And I don’t get a call. The FAA and sheriff arrive to take statements from us. I don’t hear from anyone.
The next day I start calling. No one will tell me anything, so I finally get to one of the pediatric ICU attendings who had trained me. He says Lauren literally woke up and said, “I have to go pee.” And that was it. She was 100% normal. I couldn’t believe it.
Here’s a theory: In kids, there’s something called the glottic reflex. I think her glottic reflex went off as soon as she hit the water, which basically closed her airway. So when she passed out, she could never get enough water in her lungs and still had enough air in there to keep her alive. Later, I got a call from her uncle. He could barely get the words out because he was in tears. He said Lauren was doing beautifully.
Three days later, I drove to Lauren’s house with my wife and kids. I had her read to me. I watched her play on the jungle gym for motor function. All sorts of stuff. She was totally normal.
Beth told us that the night before the accident, her mother had given the women in her family what she called a “miracle bracelet,” a bracelet that is supposed to give you one miracle in your life. Beth said she had the bracelet on her wrist the day of the accident, and now it’s gone. “Saving Lauren’s life was my miracle,” she said.
Funny thing: For 20 years, I ran all the EMS, police, fire, ambulance, in Boulder, Colo., where I live. I wrote all the protocols, and I would never advise any of my paramedics to dive into jet fuel to save someone. That was risky. But at the time, it was totally automatic. I think it taught me not to give up in certain situations, because you really don’t know.
Dr. Dorfman is an emergency medicine physician in Boulder, Colo., and medical director at Cedalion Health.
A version of this article first 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 new series telling these stories.
When the plane crashed, I was asleep. I had arrived the evening before with my wife and three sons at a house on Kezar Lake on the Maine–New Hampshire border. I jumped out of bed and ran downstairs. My kids had been watching a float plane circling and gliding along the lake. It had crashed into the water and flipped upside down. My oldest brother-in-law jumped into his ski boat and we sped out to the scene.
All we can see are the plane’s pontoons. The rest is underwater. A woman has already surfaced, screaming. I dive in.
I find the woman’s husband and 3-year-old son struggling to get free from the plane through the smashed windshield. They manage to get to the surface. The pilot is dead, impaled through the chest by the left wing strut.
The big problem: A little girl, whom I would learn later is named Lauren, remained trapped. The water is murky but I can see her, a 5- or 6-year-old girl with this long hair, strapped in upside down and unconscious.
The mom and I dive down over and over, pulling and ripping at the door. We cannot get it open. Finally, I’m able to bend the door open enough where I can reach in, but I can’t undo the seatbelt. In my mind, I’m debating, should I try and go through the front windshield? I’m getting really tired, I can tell there’s fuel in the water, and I don’t want to drown in the plane. So I pop up to the surface and yell, “Does anyone have a knife?”
My brother-in-law shoots back to shore in the boat, screaming, “Get a knife!” My niece gets in the boat with one. I’m standing on the pontoon, and my niece is in the front of the boat calling, “Uncle Todd! Uncle Todd!” and she throws the knife. It goes way over my head. I can’t even jump for it, it’s so high.
I have to get the knife. So, I dive into the water to try and find it. Somehow, the black knife has landed on the white wing, 4 or 5 feet under the water. Pure luck. It could have sunk down a hundred feet into the lake. I grab the knife and hand it to the mom, Beth. She’s able to cut the seatbelt, and we both pull Lauren to the surface.
I lay her out on the pontoon. She has no pulse and her pupils are fixed and dilated. Her mom is yelling, “She’s dead, isn’t she?” I start CPR. My skin and eyes are burning from the airplane fuel in the water. I get her breathing, and her heart comes back very quickly. Lauren starts to vomit and I’m trying to keep her airway clear. She’s breathing spontaneously and she has a pulse, so I decide it’s time to move her to shore.
We pull the boat up to the dock and Lauren’s now having anoxic seizures. Her brain has been without oxygen, and now she’s getting perfused again. We get her to shore and lay her on the lawn. I’m still doing mouth-to-mouth, but she’s seizing like crazy, and I don’t have any way to control that. Beth is crying and wants to hold her daughter gently while I’m working.
Someone had called 911, and finally this dude shows up with an ambulance, and it’s like something out of World War II. All he has is an oxygen tank, but the mask is old and cracked. It’s too big for Lauren, but it sort of fits me, so I’m sucking in oxygen and blowing it into the girl’s mouth. I’m doing whatever I can, but I don’t have an IV to start. I have no fluids. I got nothing.
As it happens, I’d done my emergency medicine training at Maine Medical Center, so I tell someone to call them and get a Life Flight chopper. We have to drive somewhere where the chopper can land, so we take the ambulance to the parking lot of the closest store called the Wicked Good Store. That’s a common thing in Maine. Everything is “wicked good.”
The whole town is there by that point. The chopper arrives. The ambulance doors pop open and a woman says, “Todd?” And I say, “Heather?”
Heather is an emergency flight nurse whom I’d trained with many years ago. There’s immediate trust. She has all the right equipment. We put in breathing tubes and IVs. We stop Lauren from seizing. The kid is soon stable.
There is only one extra seat in the chopper, so I tell Beth to go. They take off.
Suddenly, I begin to doubt my decision. Lauren had been underwater for 15 minutes at minimum. I know how long that is. Did I do the right thing? Did I resuscitate a brain-dead child? I didn’t think about it at the time, but if that patient had come to me in the emergency department, I’m honestly not sure what I would have done.
So, I go home. And I don’t get a call. The FAA and sheriff arrive to take statements from us. I don’t hear from anyone.
The next day I start calling. No one will tell me anything, so I finally get to one of the pediatric ICU attendings who had trained me. He says Lauren literally woke up and said, “I have to go pee.” And that was it. She was 100% normal. I couldn’t believe it.
Here’s a theory: In kids, there’s something called the glottic reflex. I think her glottic reflex went off as soon as she hit the water, which basically closed her airway. So when she passed out, she could never get enough water in her lungs and still had enough air in there to keep her alive. Later, I got a call from her uncle. He could barely get the words out because he was in tears. He said Lauren was doing beautifully.
Three days later, I drove to Lauren’s house with my wife and kids. I had her read to me. I watched her play on the jungle gym for motor function. All sorts of stuff. She was totally normal.
Beth told us that the night before the accident, her mother had given the women in her family what she called a “miracle bracelet,” a bracelet that is supposed to give you one miracle in your life. Beth said she had the bracelet on her wrist the day of the accident, and now it’s gone. “Saving Lauren’s life was my miracle,” she said.
Funny thing: For 20 years, I ran all the EMS, police, fire, ambulance, in Boulder, Colo., where I live. I wrote all the protocols, and I would never advise any of my paramedics to dive into jet fuel to save someone. That was risky. But at the time, it was totally automatic. I think it taught me not to give up in certain situations, because you really don’t know.
Dr. Dorfman is an emergency medicine physician in Boulder, Colo., and medical director at Cedalion Health.
A version of this article first appeared on Medscape.com.
Pulmonologist consult at COPD admission reduces risk of return
according to a retrospective cohort review presented at the annual meeting of the American College of Chest Physicians (CHEST).
“When stratified by severity of COPD at the time of admission, the difference in the readmission rate was even greater,” reported Nakisa Hekmat-Joo, MD, a third-year resident at Staten Island University Hospital, New York.
Just as protocols have been developed for prompt initiation of antibiotics in patients with septicemia or prompt revascularization in patients with ST-segment elevated myocardial infarction (STEMI), Dr. Hekmat-Joo said the data from this study warrant a larger trial to evaluate whether an AECOPD admission protocol is warranted to improve outcomes and lower costs.
In this study, all AECOPD admissions were included from a recent 2-year period at two Staten Island hospitals. Of these, 198 patients received a pulmonologist consult within 24 hours. The remaining 92 patients were not evaluated by pulmonologists but were admitted and then managed by residents, internists, or others.
The primary outcome was length of stay (LOS). Although the slightly lower LOS in pulmonologist-treated group did not approach significance (4.16 vs. 4.21 days; P = .88), the readmission rate at 90 days, which was a secondary outcome, was reduced by almost half (30.1% vs. 57.6%; P < .0001).
At admission, there was no significant difference between those receiving a pulmonologist consult and those who did not. The average O2 saturation was lower in the group seen by a pulmonologist (93% vs. 95.4%; P < .0001), but the most striking difference was the low relative readmission rate, which remained significant after controlling for severity and pulmonary function.
“When we stratified patients for baseline severity, the advantage of a pulmonologist consult was even greater for those with the most severe disease,” Dr. Hekmat-Joo said. Among those with the greatest severity, the 90-day readmission rate was nearly three times greater in the absence of a pulmonologist consult (72% vs. 28%).
Although the comparison of outcomes for those receiving a pulmonologist consult vs. those who did not was adjusted for COPD severity, the potential for pulmonologist consults to be ordered for those patients who looked the sickest would have likely worked against the study result.
“We speculate that pulmonologists were more likely than internists to treat beyond standard guidelines, particularly in the event of greater severity,” Dr. Hekmat-Joo explained. These steps might include earlier use of noninvasive positive pressure ventilation or earlier initiation of rehabilitation strategies.
There were several signals that a pulmonologist consult led to more rigorous care.
“The average time to follow-up after hospitalization was 23 days for the pulmonologist group and 66 days for the nonpulmonologist group,” said Dr. Hekmat-Joo, noting this difference was highly significant (P = .0052).
Based on these results, Dr. Hekmat-Joo and her co-investigators are now working on a protocol for COPD admissions that involves a pulmonologist consult within 24 hours of admission. She hopes to test this protocol in a prospective trial.
“COPD remains a major cause of death and consumes enormous health care resources. About 30% of the cost of COPD care is due to readmissions,” she said, noting that readmissions adversely impact quality of life.
Asked if there was sufficient staff at her institution to allow for a pulmonologist consult with every COPD admission, Dr. Hekmat-Joo acknowledged that this has to be demonstrated, but compelling evidence of a benefit might prompt a redistribution of resources.
“If we can show that readmissions are substantially reduced, adding staff to perform these consults would be a good investment,” said Dr. Hekmat-Joo, indicating that improved outcomes could also attract the attention of third-party payers and those tracking quality-of-care metrics.
There is a strong rationale for a randomized prospective trial to confirm the value of a pulmonologist consultation following admission for an acute exacerbation of COPD, according to Nicola A. Hanania, MD, director, Airways Clinical Research Center, Baylor College of Medicine, Houston.
The potential for benefit as seen in this retrospective study is a rational expectation and might be related to more appropriate therapy upon discharge as well as to earlier and more rigorous follow-up, according to Dr. Hanania. Although he cautioned that there is a meaningful risk of selection bias in a retrospective study, he thinks this study “is certainly probing an important issue.”
“Mortality from a hospitalized COPD exacerbation exceeds that of a myocardial infarction,” Dr. Hanania pointed out. Noting that all patients with an MI are evaluated by a cardiologist, he sees the logic of a pulmonologist consult – although he acknowledged that evidence is needed.
“I strongly believe that a prospective study is feasible and will answer the question in an unbiased manner if done properly,” he said in an interview. If a multicenter, well-controlled study was positive, it could change practice.
In the event of a study showing major clinical benefits, particularly a reduction in mortality, “I believe it is feasible to have a pulmonary consult to see every COPD exacerbation patient admitted to the hospital,” Dr. Hanania said.
Dr. Hekmat-Joo reports no relevant financial relationships. Dr. Hanania has financial relationships with AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Mylan, Novartis, Regeneron, Sanofi, and Sunovion.
A version of this article first appeared on Medscape.com.
according to a retrospective cohort review presented at the annual meeting of the American College of Chest Physicians (CHEST).
“When stratified by severity of COPD at the time of admission, the difference in the readmission rate was even greater,” reported Nakisa Hekmat-Joo, MD, a third-year resident at Staten Island University Hospital, New York.
Just as protocols have been developed for prompt initiation of antibiotics in patients with septicemia or prompt revascularization in patients with ST-segment elevated myocardial infarction (STEMI), Dr. Hekmat-Joo said the data from this study warrant a larger trial to evaluate whether an AECOPD admission protocol is warranted to improve outcomes and lower costs.
In this study, all AECOPD admissions were included from a recent 2-year period at two Staten Island hospitals. Of these, 198 patients received a pulmonologist consult within 24 hours. The remaining 92 patients were not evaluated by pulmonologists but were admitted and then managed by residents, internists, or others.
The primary outcome was length of stay (LOS). Although the slightly lower LOS in pulmonologist-treated group did not approach significance (4.16 vs. 4.21 days; P = .88), the readmission rate at 90 days, which was a secondary outcome, was reduced by almost half (30.1% vs. 57.6%; P < .0001).
At admission, there was no significant difference between those receiving a pulmonologist consult and those who did not. The average O2 saturation was lower in the group seen by a pulmonologist (93% vs. 95.4%; P < .0001), but the most striking difference was the low relative readmission rate, which remained significant after controlling for severity and pulmonary function.
“When we stratified patients for baseline severity, the advantage of a pulmonologist consult was even greater for those with the most severe disease,” Dr. Hekmat-Joo said. Among those with the greatest severity, the 90-day readmission rate was nearly three times greater in the absence of a pulmonologist consult (72% vs. 28%).
Although the comparison of outcomes for those receiving a pulmonologist consult vs. those who did not was adjusted for COPD severity, the potential for pulmonologist consults to be ordered for those patients who looked the sickest would have likely worked against the study result.
“We speculate that pulmonologists were more likely than internists to treat beyond standard guidelines, particularly in the event of greater severity,” Dr. Hekmat-Joo explained. These steps might include earlier use of noninvasive positive pressure ventilation or earlier initiation of rehabilitation strategies.
There were several signals that a pulmonologist consult led to more rigorous care.
“The average time to follow-up after hospitalization was 23 days for the pulmonologist group and 66 days for the nonpulmonologist group,” said Dr. Hekmat-Joo, noting this difference was highly significant (P = .0052).
Based on these results, Dr. Hekmat-Joo and her co-investigators are now working on a protocol for COPD admissions that involves a pulmonologist consult within 24 hours of admission. She hopes to test this protocol in a prospective trial.
“COPD remains a major cause of death and consumes enormous health care resources. About 30% of the cost of COPD care is due to readmissions,” she said, noting that readmissions adversely impact quality of life.
Asked if there was sufficient staff at her institution to allow for a pulmonologist consult with every COPD admission, Dr. Hekmat-Joo acknowledged that this has to be demonstrated, but compelling evidence of a benefit might prompt a redistribution of resources.
“If we can show that readmissions are substantially reduced, adding staff to perform these consults would be a good investment,” said Dr. Hekmat-Joo, indicating that improved outcomes could also attract the attention of third-party payers and those tracking quality-of-care metrics.
There is a strong rationale for a randomized prospective trial to confirm the value of a pulmonologist consultation following admission for an acute exacerbation of COPD, according to Nicola A. Hanania, MD, director, Airways Clinical Research Center, Baylor College of Medicine, Houston.
The potential for benefit as seen in this retrospective study is a rational expectation and might be related to more appropriate therapy upon discharge as well as to earlier and more rigorous follow-up, according to Dr. Hanania. Although he cautioned that there is a meaningful risk of selection bias in a retrospective study, he thinks this study “is certainly probing an important issue.”
“Mortality from a hospitalized COPD exacerbation exceeds that of a myocardial infarction,” Dr. Hanania pointed out. Noting that all patients with an MI are evaluated by a cardiologist, he sees the logic of a pulmonologist consult – although he acknowledged that evidence is needed.
“I strongly believe that a prospective study is feasible and will answer the question in an unbiased manner if done properly,” he said in an interview. If a multicenter, well-controlled study was positive, it could change practice.
In the event of a study showing major clinical benefits, particularly a reduction in mortality, “I believe it is feasible to have a pulmonary consult to see every COPD exacerbation patient admitted to the hospital,” Dr. Hanania said.
Dr. Hekmat-Joo reports no relevant financial relationships. Dr. Hanania has financial relationships with AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Mylan, Novartis, Regeneron, Sanofi, and Sunovion.
A version of this article first appeared on Medscape.com.
according to a retrospective cohort review presented at the annual meeting of the American College of Chest Physicians (CHEST).
“When stratified by severity of COPD at the time of admission, the difference in the readmission rate was even greater,” reported Nakisa Hekmat-Joo, MD, a third-year resident at Staten Island University Hospital, New York.
Just as protocols have been developed for prompt initiation of antibiotics in patients with septicemia or prompt revascularization in patients with ST-segment elevated myocardial infarction (STEMI), Dr. Hekmat-Joo said the data from this study warrant a larger trial to evaluate whether an AECOPD admission protocol is warranted to improve outcomes and lower costs.
In this study, all AECOPD admissions were included from a recent 2-year period at two Staten Island hospitals. Of these, 198 patients received a pulmonologist consult within 24 hours. The remaining 92 patients were not evaluated by pulmonologists but were admitted and then managed by residents, internists, or others.
The primary outcome was length of stay (LOS). Although the slightly lower LOS in pulmonologist-treated group did not approach significance (4.16 vs. 4.21 days; P = .88), the readmission rate at 90 days, which was a secondary outcome, was reduced by almost half (30.1% vs. 57.6%; P < .0001).
At admission, there was no significant difference between those receiving a pulmonologist consult and those who did not. The average O2 saturation was lower in the group seen by a pulmonologist (93% vs. 95.4%; P < .0001), but the most striking difference was the low relative readmission rate, which remained significant after controlling for severity and pulmonary function.
“When we stratified patients for baseline severity, the advantage of a pulmonologist consult was even greater for those with the most severe disease,” Dr. Hekmat-Joo said. Among those with the greatest severity, the 90-day readmission rate was nearly three times greater in the absence of a pulmonologist consult (72% vs. 28%).
Although the comparison of outcomes for those receiving a pulmonologist consult vs. those who did not was adjusted for COPD severity, the potential for pulmonologist consults to be ordered for those patients who looked the sickest would have likely worked against the study result.
“We speculate that pulmonologists were more likely than internists to treat beyond standard guidelines, particularly in the event of greater severity,” Dr. Hekmat-Joo explained. These steps might include earlier use of noninvasive positive pressure ventilation or earlier initiation of rehabilitation strategies.
There were several signals that a pulmonologist consult led to more rigorous care.
“The average time to follow-up after hospitalization was 23 days for the pulmonologist group and 66 days for the nonpulmonologist group,” said Dr. Hekmat-Joo, noting this difference was highly significant (P = .0052).
Based on these results, Dr. Hekmat-Joo and her co-investigators are now working on a protocol for COPD admissions that involves a pulmonologist consult within 24 hours of admission. She hopes to test this protocol in a prospective trial.
“COPD remains a major cause of death and consumes enormous health care resources. About 30% of the cost of COPD care is due to readmissions,” she said, noting that readmissions adversely impact quality of life.
Asked if there was sufficient staff at her institution to allow for a pulmonologist consult with every COPD admission, Dr. Hekmat-Joo acknowledged that this has to be demonstrated, but compelling evidence of a benefit might prompt a redistribution of resources.
“If we can show that readmissions are substantially reduced, adding staff to perform these consults would be a good investment,” said Dr. Hekmat-Joo, indicating that improved outcomes could also attract the attention of third-party payers and those tracking quality-of-care metrics.
There is a strong rationale for a randomized prospective trial to confirm the value of a pulmonologist consultation following admission for an acute exacerbation of COPD, according to Nicola A. Hanania, MD, director, Airways Clinical Research Center, Baylor College of Medicine, Houston.
The potential for benefit as seen in this retrospective study is a rational expectation and might be related to more appropriate therapy upon discharge as well as to earlier and more rigorous follow-up, according to Dr. Hanania. Although he cautioned that there is a meaningful risk of selection bias in a retrospective study, he thinks this study “is certainly probing an important issue.”
“Mortality from a hospitalized COPD exacerbation exceeds that of a myocardial infarction,” Dr. Hanania pointed out. Noting that all patients with an MI are evaluated by a cardiologist, he sees the logic of a pulmonologist consult – although he acknowledged that evidence is needed.
“I strongly believe that a prospective study is feasible and will answer the question in an unbiased manner if done properly,” he said in an interview. If a multicenter, well-controlled study was positive, it could change practice.
In the event of a study showing major clinical benefits, particularly a reduction in mortality, “I believe it is feasible to have a pulmonary consult to see every COPD exacerbation patient admitted to the hospital,” Dr. Hanania said.
Dr. Hekmat-Joo reports no relevant financial relationships. Dr. Hanania has financial relationships with AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Mylan, Novartis, Regeneron, Sanofi, and Sunovion.
A version of this article first appeared on Medscape.com.
FROM CHEST 2022
More data suggest preexisting statin use improves COVID outcomes
Compared with patients who didn’t take statins, statin users had better health outcomes. For those who used these medications, the researchers saw lower mortality, lower clinical severity, and shorter hospital stays, aligning with previous observational studies, said lead author Ettore Crimi, MD, of the University of Central Florida, Orlando, and colleagues in their abstract, which was part of the agenda for the Anesthesiology annual meeting.
They attributed these clinical improvements to the pleiotropic – non–cholesterol lowering – effects of statins.
“[These] benefits of statins have been reported since the 1990s,” Dr. Crimi said in an interview. “Statin treatment has been associated with a marked reduction of markers of inflammation, such as erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), interleukin-6 (IL-6), ferritin, and white blood cell count, among others.”
He noted that these effects have been studied in an array of conditions, including cancer, autoimmune diseases, chronic inflammatory disease, and in the perioperative setting, and with infectious diseases, including COVID-19.
In those previous studies, “preexisting statin use was protective among hospitalized COVID-19 patients, but a large, multicenter cohort study has not been reported in the United States,” Dr. Crimi and his colleagues wrote in their abstract.
To address this knowledge gap, they turned to electronic medical records from 38,875 patients hospitalized with COVID-19 from January to September 2020. Almost one-third of the population (n = 11,533) were using statins prior to hospitalization, while the remainder (n = 27,342) were nonusers.
The primary outcome was all-cause mortality. Secondary outcomes included death from COVID-19, along with a variety of severe complications. While the analysis did account for a range of potentially confounding variables, the effects of different SARS-CoV-2 variants and new therapeutics were not considered. Vaccines were not yet available at the time the data were collected.
Statin users had a 31% lower rate of all-cause mortality (odds ratio, 0.69; 95% confidence interval, 0.64-0.75; P = .001) and a 37% reduced rate of death from COVID-19 (OR, 0.63; 95% CI, 0.58-0.69; P = .001).
A litany of other secondary variables also favored statin users, including reduced rates of discharge to hospice (OR, 0.79), ICU admission (OR, 0.69), severe acute respiratory distress syndrome (ARDs; OR, 0.72), critical ARDs (OR, 0.57), mechanical ventilation (OR, 0.60), severe sepsis with septic shock (OR, 0.66), and thrombosis (OR, 0.46). Statin users also had, on average, shorter hospital stays and briefer mechanical ventilation.
“Our study showed a strong association between preexisting statin use and reduced mortality and morbidity rates in hospitalized COVID-19 patients,” the investigators concluded. “Pleiotropic benefits of statins could be repurposed for COVID-19 illness.”
Prospective studies needed before practice changes
How to best use statins against COVID-19, if at all, remains unclear, Dr. Crimi said, as initiation upon infection has generated mixed results in other studies, possibly because of statin pharmacodynamics. Cholesterol normalization can take about 6 weeks, so other benefits may track a similar timeline.
“The delayed onset of statins’ pleiotropic effects may likely fail to keep pace with the rapidly progressive, devastating COVID-19 disease,” Dr. Crimi said. “Therefore, initiating statins for an acute disease may not be an ideal first-line treatment.”
Stronger data are on the horizon, he added, noting that 19 federally funded prospective trials are underway to better understand the relationship between statins and COVID-19.
Daniel Rader, MD, of the University of Pennsylvania, Philadelphia, said the present findings are “not especially notable” because they “mostly confirm previous studies, but in a large U.S. cohort.”
Dr. Rader, who wrote about the potential repurposing of statins for COVID-19 back in the first year of the pandemic (Cell Metab. 2020 Aug 4;32[2]:145-7), agreed with the investigators that recommending changes to clinical practice would be imprudent until randomized controlled data confirm the benefits of initiating statins in patients with active COVID-19.
“More research on the impact of cellular cholesterol metabolism on SARS-CoV-2 infection of cells and generation of inflammation would also be of interest,” he added.
The investigators disclosed no competing interests. Dr. Rader disclosed relationships with Novartis, Pfizer, Verve, and others.
Compared with patients who didn’t take statins, statin users had better health outcomes. For those who used these medications, the researchers saw lower mortality, lower clinical severity, and shorter hospital stays, aligning with previous observational studies, said lead author Ettore Crimi, MD, of the University of Central Florida, Orlando, and colleagues in their abstract, which was part of the agenda for the Anesthesiology annual meeting.
They attributed these clinical improvements to the pleiotropic – non–cholesterol lowering – effects of statins.
“[These] benefits of statins have been reported since the 1990s,” Dr. Crimi said in an interview. “Statin treatment has been associated with a marked reduction of markers of inflammation, such as erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), interleukin-6 (IL-6), ferritin, and white blood cell count, among others.”
He noted that these effects have been studied in an array of conditions, including cancer, autoimmune diseases, chronic inflammatory disease, and in the perioperative setting, and with infectious diseases, including COVID-19.
In those previous studies, “preexisting statin use was protective among hospitalized COVID-19 patients, but a large, multicenter cohort study has not been reported in the United States,” Dr. Crimi and his colleagues wrote in their abstract.
To address this knowledge gap, they turned to electronic medical records from 38,875 patients hospitalized with COVID-19 from January to September 2020. Almost one-third of the population (n = 11,533) were using statins prior to hospitalization, while the remainder (n = 27,342) were nonusers.
The primary outcome was all-cause mortality. Secondary outcomes included death from COVID-19, along with a variety of severe complications. While the analysis did account for a range of potentially confounding variables, the effects of different SARS-CoV-2 variants and new therapeutics were not considered. Vaccines were not yet available at the time the data were collected.
Statin users had a 31% lower rate of all-cause mortality (odds ratio, 0.69; 95% confidence interval, 0.64-0.75; P = .001) and a 37% reduced rate of death from COVID-19 (OR, 0.63; 95% CI, 0.58-0.69; P = .001).
A litany of other secondary variables also favored statin users, including reduced rates of discharge to hospice (OR, 0.79), ICU admission (OR, 0.69), severe acute respiratory distress syndrome (ARDs; OR, 0.72), critical ARDs (OR, 0.57), mechanical ventilation (OR, 0.60), severe sepsis with septic shock (OR, 0.66), and thrombosis (OR, 0.46). Statin users also had, on average, shorter hospital stays and briefer mechanical ventilation.
“Our study showed a strong association between preexisting statin use and reduced mortality and morbidity rates in hospitalized COVID-19 patients,” the investigators concluded. “Pleiotropic benefits of statins could be repurposed for COVID-19 illness.”
Prospective studies needed before practice changes
How to best use statins against COVID-19, if at all, remains unclear, Dr. Crimi said, as initiation upon infection has generated mixed results in other studies, possibly because of statin pharmacodynamics. Cholesterol normalization can take about 6 weeks, so other benefits may track a similar timeline.
“The delayed onset of statins’ pleiotropic effects may likely fail to keep pace with the rapidly progressive, devastating COVID-19 disease,” Dr. Crimi said. “Therefore, initiating statins for an acute disease may not be an ideal first-line treatment.”
Stronger data are on the horizon, he added, noting that 19 federally funded prospective trials are underway to better understand the relationship between statins and COVID-19.
Daniel Rader, MD, of the University of Pennsylvania, Philadelphia, said the present findings are “not especially notable” because they “mostly confirm previous studies, but in a large U.S. cohort.”
Dr. Rader, who wrote about the potential repurposing of statins for COVID-19 back in the first year of the pandemic (Cell Metab. 2020 Aug 4;32[2]:145-7), agreed with the investigators that recommending changes to clinical practice would be imprudent until randomized controlled data confirm the benefits of initiating statins in patients with active COVID-19.
“More research on the impact of cellular cholesterol metabolism on SARS-CoV-2 infection of cells and generation of inflammation would also be of interest,” he added.
The investigators disclosed no competing interests. Dr. Rader disclosed relationships with Novartis, Pfizer, Verve, and others.
Compared with patients who didn’t take statins, statin users had better health outcomes. For those who used these medications, the researchers saw lower mortality, lower clinical severity, and shorter hospital stays, aligning with previous observational studies, said lead author Ettore Crimi, MD, of the University of Central Florida, Orlando, and colleagues in their abstract, which was part of the agenda for the Anesthesiology annual meeting.
They attributed these clinical improvements to the pleiotropic – non–cholesterol lowering – effects of statins.
“[These] benefits of statins have been reported since the 1990s,” Dr. Crimi said in an interview. “Statin treatment has been associated with a marked reduction of markers of inflammation, such as erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), interleukin-6 (IL-6), ferritin, and white blood cell count, among others.”
He noted that these effects have been studied in an array of conditions, including cancer, autoimmune diseases, chronic inflammatory disease, and in the perioperative setting, and with infectious diseases, including COVID-19.
In those previous studies, “preexisting statin use was protective among hospitalized COVID-19 patients, but a large, multicenter cohort study has not been reported in the United States,” Dr. Crimi and his colleagues wrote in their abstract.
To address this knowledge gap, they turned to electronic medical records from 38,875 patients hospitalized with COVID-19 from January to September 2020. Almost one-third of the population (n = 11,533) were using statins prior to hospitalization, while the remainder (n = 27,342) were nonusers.
The primary outcome was all-cause mortality. Secondary outcomes included death from COVID-19, along with a variety of severe complications. While the analysis did account for a range of potentially confounding variables, the effects of different SARS-CoV-2 variants and new therapeutics were not considered. Vaccines were not yet available at the time the data were collected.
Statin users had a 31% lower rate of all-cause mortality (odds ratio, 0.69; 95% confidence interval, 0.64-0.75; P = .001) and a 37% reduced rate of death from COVID-19 (OR, 0.63; 95% CI, 0.58-0.69; P = .001).
A litany of other secondary variables also favored statin users, including reduced rates of discharge to hospice (OR, 0.79), ICU admission (OR, 0.69), severe acute respiratory distress syndrome (ARDs; OR, 0.72), critical ARDs (OR, 0.57), mechanical ventilation (OR, 0.60), severe sepsis with septic shock (OR, 0.66), and thrombosis (OR, 0.46). Statin users also had, on average, shorter hospital stays and briefer mechanical ventilation.
“Our study showed a strong association between preexisting statin use and reduced mortality and morbidity rates in hospitalized COVID-19 patients,” the investigators concluded. “Pleiotropic benefits of statins could be repurposed for COVID-19 illness.”
Prospective studies needed before practice changes
How to best use statins against COVID-19, if at all, remains unclear, Dr. Crimi said, as initiation upon infection has generated mixed results in other studies, possibly because of statin pharmacodynamics. Cholesterol normalization can take about 6 weeks, so other benefits may track a similar timeline.
“The delayed onset of statins’ pleiotropic effects may likely fail to keep pace with the rapidly progressive, devastating COVID-19 disease,” Dr. Crimi said. “Therefore, initiating statins for an acute disease may not be an ideal first-line treatment.”
Stronger data are on the horizon, he added, noting that 19 federally funded prospective trials are underway to better understand the relationship between statins and COVID-19.
Daniel Rader, MD, of the University of Pennsylvania, Philadelphia, said the present findings are “not especially notable” because they “mostly confirm previous studies, but in a large U.S. cohort.”
Dr. Rader, who wrote about the potential repurposing of statins for COVID-19 back in the first year of the pandemic (Cell Metab. 2020 Aug 4;32[2]:145-7), agreed with the investigators that recommending changes to clinical practice would be imprudent until randomized controlled data confirm the benefits of initiating statins in patients with active COVID-19.
“More research on the impact of cellular cholesterol metabolism on SARS-CoV-2 infection of cells and generation of inflammation would also be of interest,” he added.
The investigators disclosed no competing interests. Dr. Rader disclosed relationships with Novartis, Pfizer, Verve, and others.
FROM ANESTHESIOLOGY 2022
Hospitalizations for VAP rose prior to pandemic
Health care–associated infections are a significant burden, and “ventilator associated-pneumonia is a contributor to that,” said Namratha S. Meda, MBBS, in a presentation at the annual meeting of the American College of Chest Physicians.
VAP can affect length of stay and other costs, but factors related to VAP hospitalization have not been well studied, said Dr. Meda, of Medstar Health/Georgetown University Hospital, Washington.
To examine trends in hospitalization for VAP, Dr. Meda and colleagues reviewed data from the National Inpatient Sample from January 2013 to December 2019. The study population included adult patients with VAP as a primary or secondary diagnosis based on ICD-9 or ICD-10 codes.
Overall, the trend in hospitalizations showed a consistent increase, said Dr. Meda.
The researchers identified 128,025 adult hospitalizations with VAP during the study period, with an increase from 50 VAP cases per 100,000 hospitalizations in 2013 to 75 cases per 100,000 hospitalizations in 2019.
A total of 42,120 hospitalizations were associated with tracheostomy, ventilator dependence, or both. Hospitalizations in these categories increased by 80% during the study period, from 15 cases per 100,000 hospitalizations in 2013 to 27 cases per 100,000 hospitalizations in 2019.
The median cost for each hospitalization was $83,311, and showed a 2.9% increase from 2013 to 2019. The estimated annual cost of VAP hospitalizations was approximately $2.8 billion in 2019, Dr. Meda emphasized. However, all-cause hospital mortality remained unchanged over the study period, at approximately 20%.
The mean age of the hospitalized VAP patients was 58 years across all VAP-related hospitalizations, and 36.5% were women. More than half (58%) were White, 21% were Black, and 12% were Hispanic.
The researchers noted some sex and racial disparities; the median age was lower for Black and Hispanic patients, compared with White patients, but all-cause mortality was lower. Men had a significantly longer median length of stay, compared with women (21 days vs. 19 days), and higher median costs ($87,981 vs. $74,889) with a P <.001 for both, but the all-cause in-hospital mortality was not significantly different between sexes.
The steady increase in hospitalization for VAP without a significant change in all-cause mortality, might be driven by hospitals with higher levels of tracheostomy and ventilator dependence, but more research is needed, Dr. Meda noted.
The study was limited by the observational design, which allowed the researchers to report an association, but not causality, said Dr. Meda. However, the results reflect the ongoing financial burden of VAP on the health care system, although “it would be interesting to see how the trend might change if we just looked at the clinical definition versus billing data,” she noted.
The study did not include data since the advent of COVID-19, but COVID is likely to drive the trend of increasing VAP hospitalization higher, Dr. Meda added.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Health care–associated infections are a significant burden, and “ventilator associated-pneumonia is a contributor to that,” said Namratha S. Meda, MBBS, in a presentation at the annual meeting of the American College of Chest Physicians.
VAP can affect length of stay and other costs, but factors related to VAP hospitalization have not been well studied, said Dr. Meda, of Medstar Health/Georgetown University Hospital, Washington.
To examine trends in hospitalization for VAP, Dr. Meda and colleagues reviewed data from the National Inpatient Sample from January 2013 to December 2019. The study population included adult patients with VAP as a primary or secondary diagnosis based on ICD-9 or ICD-10 codes.
Overall, the trend in hospitalizations showed a consistent increase, said Dr. Meda.
The researchers identified 128,025 adult hospitalizations with VAP during the study period, with an increase from 50 VAP cases per 100,000 hospitalizations in 2013 to 75 cases per 100,000 hospitalizations in 2019.
A total of 42,120 hospitalizations were associated with tracheostomy, ventilator dependence, or both. Hospitalizations in these categories increased by 80% during the study period, from 15 cases per 100,000 hospitalizations in 2013 to 27 cases per 100,000 hospitalizations in 2019.
The median cost for each hospitalization was $83,311, and showed a 2.9% increase from 2013 to 2019. The estimated annual cost of VAP hospitalizations was approximately $2.8 billion in 2019, Dr. Meda emphasized. However, all-cause hospital mortality remained unchanged over the study period, at approximately 20%.
The mean age of the hospitalized VAP patients was 58 years across all VAP-related hospitalizations, and 36.5% were women. More than half (58%) were White, 21% were Black, and 12% were Hispanic.
The researchers noted some sex and racial disparities; the median age was lower for Black and Hispanic patients, compared with White patients, but all-cause mortality was lower. Men had a significantly longer median length of stay, compared with women (21 days vs. 19 days), and higher median costs ($87,981 vs. $74,889) with a P <.001 for both, but the all-cause in-hospital mortality was not significantly different between sexes.
The steady increase in hospitalization for VAP without a significant change in all-cause mortality, might be driven by hospitals with higher levels of tracheostomy and ventilator dependence, but more research is needed, Dr. Meda noted.
The study was limited by the observational design, which allowed the researchers to report an association, but not causality, said Dr. Meda. However, the results reflect the ongoing financial burden of VAP on the health care system, although “it would be interesting to see how the trend might change if we just looked at the clinical definition versus billing data,” she noted.
The study did not include data since the advent of COVID-19, but COVID is likely to drive the trend of increasing VAP hospitalization higher, Dr. Meda added.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Health care–associated infections are a significant burden, and “ventilator associated-pneumonia is a contributor to that,” said Namratha S. Meda, MBBS, in a presentation at the annual meeting of the American College of Chest Physicians.
VAP can affect length of stay and other costs, but factors related to VAP hospitalization have not been well studied, said Dr. Meda, of Medstar Health/Georgetown University Hospital, Washington.
To examine trends in hospitalization for VAP, Dr. Meda and colleagues reviewed data from the National Inpatient Sample from January 2013 to December 2019. The study population included adult patients with VAP as a primary or secondary diagnosis based on ICD-9 or ICD-10 codes.
Overall, the trend in hospitalizations showed a consistent increase, said Dr. Meda.
The researchers identified 128,025 adult hospitalizations with VAP during the study period, with an increase from 50 VAP cases per 100,000 hospitalizations in 2013 to 75 cases per 100,000 hospitalizations in 2019.
A total of 42,120 hospitalizations were associated with tracheostomy, ventilator dependence, or both. Hospitalizations in these categories increased by 80% during the study period, from 15 cases per 100,000 hospitalizations in 2013 to 27 cases per 100,000 hospitalizations in 2019.
The median cost for each hospitalization was $83,311, and showed a 2.9% increase from 2013 to 2019. The estimated annual cost of VAP hospitalizations was approximately $2.8 billion in 2019, Dr. Meda emphasized. However, all-cause hospital mortality remained unchanged over the study period, at approximately 20%.
The mean age of the hospitalized VAP patients was 58 years across all VAP-related hospitalizations, and 36.5% were women. More than half (58%) were White, 21% were Black, and 12% were Hispanic.
The researchers noted some sex and racial disparities; the median age was lower for Black and Hispanic patients, compared with White patients, but all-cause mortality was lower. Men had a significantly longer median length of stay, compared with women (21 days vs. 19 days), and higher median costs ($87,981 vs. $74,889) with a P <.001 for both, but the all-cause in-hospital mortality was not significantly different between sexes.
The steady increase in hospitalization for VAP without a significant change in all-cause mortality, might be driven by hospitals with higher levels of tracheostomy and ventilator dependence, but more research is needed, Dr. Meda noted.
The study was limited by the observational design, which allowed the researchers to report an association, but not causality, said Dr. Meda. However, the results reflect the ongoing financial burden of VAP on the health care system, although “it would be interesting to see how the trend might change if we just looked at the clinical definition versus billing data,” she noted.
The study did not include data since the advent of COVID-19, but COVID is likely to drive the trend of increasing VAP hospitalization higher, Dr. Meda added.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM CHEST 2022