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Have you heard the one about the emergency dept. that called 911?
Who watches the ED staff?
We heard a really great joke recently, one we simply have to share.
A man in Seattle went to a therapist. “I’m depressed,” he says. “Depressed, overworked, and lonely.”
“Oh dear, that sounds quite serious,” the therapist replies. “Tell me all about it.”
“Life just seems so harsh and cruel,” the man explains. “The pandemic has caused 300,000 health care workers across the country to leave the industry.”
“Such as the doctor typically filling this role in the joke,” the therapist, who is not licensed to prescribe medicine, nods.
“Exactly! And with so many respiratory viruses circulating and COVID still hanging around, emergency departments all over the country are facing massive backups. People are waiting outside the hospital for hours, hoping a bed will open up. Things got so bad at a hospital near Seattle in October that a nurse called 911 on her own ED. Told the 911 operator to send the fire department to help out, since they were ‘drowning’ and ‘in dire straits.’ They had 45 patients waiting and only five nurses to take care of them.”
“That is quite serious,” the therapist says, scribbling down unseen notes.
“The fire chief did send a crew out, and they cleaned rooms, changed beds, and took vitals for 90 minutes until the crisis passed,” the man says. “But it’s only a matter of time before it happens again. The hospital president said they have 300 open positions, and literally no one has applied to work in the emergency department. Not one person.”
“And how does all this make you feel?” the therapist asks.
“I feel all alone,” the man says. “This world feels so threatening, like no one cares, and I have no idea what will come next. It’s so vague and uncertain.”
“Ah, I think I have a solution for you,” the therapist says. “Go to the emergency department at St. Michael Medical Center in Silverdale, near Seattle. They’ll get your bad mood all settled, and they’ll prescribe you the medicine you need to relax.”
The man bursts into tears. “You don’t understand,” he says. “I am the emergency department at St. Michael Medical Center.”
Good joke. Everybody laugh. Roll on snare drum. Curtains.
Myth buster: Supplements for cholesterol lowering
When it comes to that nasty low-density lipoprotein cholesterol, some people swear by supplements over statins as a holistic approach. Well, we’re busting the myth that those heart-healthy supplements are even effective in comparison.
Which supplements are we talking about? These six are always on sale at the pharmacy: fish oil, cinnamon, garlic, turmeric, plant sterols, and red yeast rice.
In a study presented at the recent American Heart Association scientific sessions, researchers compared these supplements’ effectiveness in lowering LDL cholesterol with low-dose rosuvastatin or placebo among 199 adults aged 40-75 years who didn’t have a personal history of cardiovascular disease.
Participants who took the statin for 28 days had an average of 24% decrease in total cholesterol and a 38% reduction in LDL cholesterol, while 28 days’ worth of the supplements did no better than the placebo in either measure. Compared with placebo, the plant sterols supplement notably lowered HDL cholesterol and the garlic supplement notably increased LDL cholesterol.
Even though there are other studies showing the validity of plant sterols and red yeast rice to lower LDL cholesterol, author Luke J. Laffin, MD, of the Cleveland Clinic noted that this study shows how supplement results can vary and that more research is needed to see the effect they truly have on cholesterol over time.
So, should you stop taking or recommending supplements for heart health or healthy cholesterol levels? Well, we’re not going to come to your house and raid your medicine cabinet, but the authors of this study are definitely not saying that you should rely on them.
Consider this myth mostly busted.
COVID dept. of unintended consequences, part 2
The surveillance testing programs conducted in the first year of the pandemic were, in theory, meant to keep everyone safer. Someone, apparently, forgot to explain that to the students of the University of Wyoming and the University of Idaho.
We’re all familiar with the drill: Students at the two schools had to undergo frequent COVID screening to keep the virus from spreading, thereby making everyone safer. Duck your head now, because here comes the unintended consequence.
The students who didn’t get COVID eventually, and perhaps not so surprisingly, “perceived that the mandatory testing policy decreased their risk of contracting COVID-19, and … this perception led to higher participation in COVID-risky events,” Chian Jones Ritten, PhD, and associates said in PNAS Nexus.
They surveyed 757 students from the Univ. of Washington and 517 from the Univ. of Idaho and found that those who were tested more frequently perceived that they were less likely to contract the virus. Those respondents also more frequently attended indoor gatherings, both small and large, and spent more time in restaurants and bars.
The investigators did not mince words: “From a public health standpoint, such behavior is problematic.”
Current parents/participants in the workforce might have other ideas about an appropriate response to COVID.
At this point, we probably should mention that appropriation is the second-most sincere form of flattery.
Who watches the ED staff?
We heard a really great joke recently, one we simply have to share.
A man in Seattle went to a therapist. “I’m depressed,” he says. “Depressed, overworked, and lonely.”
“Oh dear, that sounds quite serious,” the therapist replies. “Tell me all about it.”
“Life just seems so harsh and cruel,” the man explains. “The pandemic has caused 300,000 health care workers across the country to leave the industry.”
“Such as the doctor typically filling this role in the joke,” the therapist, who is not licensed to prescribe medicine, nods.
“Exactly! And with so many respiratory viruses circulating and COVID still hanging around, emergency departments all over the country are facing massive backups. People are waiting outside the hospital for hours, hoping a bed will open up. Things got so bad at a hospital near Seattle in October that a nurse called 911 on her own ED. Told the 911 operator to send the fire department to help out, since they were ‘drowning’ and ‘in dire straits.’ They had 45 patients waiting and only five nurses to take care of them.”
“That is quite serious,” the therapist says, scribbling down unseen notes.
“The fire chief did send a crew out, and they cleaned rooms, changed beds, and took vitals for 90 minutes until the crisis passed,” the man says. “But it’s only a matter of time before it happens again. The hospital president said they have 300 open positions, and literally no one has applied to work in the emergency department. Not one person.”
“And how does all this make you feel?” the therapist asks.
“I feel all alone,” the man says. “This world feels so threatening, like no one cares, and I have no idea what will come next. It’s so vague and uncertain.”
“Ah, I think I have a solution for you,” the therapist says. “Go to the emergency department at St. Michael Medical Center in Silverdale, near Seattle. They’ll get your bad mood all settled, and they’ll prescribe you the medicine you need to relax.”
The man bursts into tears. “You don’t understand,” he says. “I am the emergency department at St. Michael Medical Center.”
Good joke. Everybody laugh. Roll on snare drum. Curtains.
Myth buster: Supplements for cholesterol lowering
When it comes to that nasty low-density lipoprotein cholesterol, some people swear by supplements over statins as a holistic approach. Well, we’re busting the myth that those heart-healthy supplements are even effective in comparison.
Which supplements are we talking about? These six are always on sale at the pharmacy: fish oil, cinnamon, garlic, turmeric, plant sterols, and red yeast rice.
In a study presented at the recent American Heart Association scientific sessions, researchers compared these supplements’ effectiveness in lowering LDL cholesterol with low-dose rosuvastatin or placebo among 199 adults aged 40-75 years who didn’t have a personal history of cardiovascular disease.
Participants who took the statin for 28 days had an average of 24% decrease in total cholesterol and a 38% reduction in LDL cholesterol, while 28 days’ worth of the supplements did no better than the placebo in either measure. Compared with placebo, the plant sterols supplement notably lowered HDL cholesterol and the garlic supplement notably increased LDL cholesterol.
Even though there are other studies showing the validity of plant sterols and red yeast rice to lower LDL cholesterol, author Luke J. Laffin, MD, of the Cleveland Clinic noted that this study shows how supplement results can vary and that more research is needed to see the effect they truly have on cholesterol over time.
So, should you stop taking or recommending supplements for heart health or healthy cholesterol levels? Well, we’re not going to come to your house and raid your medicine cabinet, but the authors of this study are definitely not saying that you should rely on them.
Consider this myth mostly busted.
COVID dept. of unintended consequences, part 2
The surveillance testing programs conducted in the first year of the pandemic were, in theory, meant to keep everyone safer. Someone, apparently, forgot to explain that to the students of the University of Wyoming and the University of Idaho.
We’re all familiar with the drill: Students at the two schools had to undergo frequent COVID screening to keep the virus from spreading, thereby making everyone safer. Duck your head now, because here comes the unintended consequence.
The students who didn’t get COVID eventually, and perhaps not so surprisingly, “perceived that the mandatory testing policy decreased their risk of contracting COVID-19, and … this perception led to higher participation in COVID-risky events,” Chian Jones Ritten, PhD, and associates said in PNAS Nexus.
They surveyed 757 students from the Univ. of Washington and 517 from the Univ. of Idaho and found that those who were tested more frequently perceived that they were less likely to contract the virus. Those respondents also more frequently attended indoor gatherings, both small and large, and spent more time in restaurants and bars.
The investigators did not mince words: “From a public health standpoint, such behavior is problematic.”
Current parents/participants in the workforce might have other ideas about an appropriate response to COVID.
At this point, we probably should mention that appropriation is the second-most sincere form of flattery.
Who watches the ED staff?
We heard a really great joke recently, one we simply have to share.
A man in Seattle went to a therapist. “I’m depressed,” he says. “Depressed, overworked, and lonely.”
“Oh dear, that sounds quite serious,” the therapist replies. “Tell me all about it.”
“Life just seems so harsh and cruel,” the man explains. “The pandemic has caused 300,000 health care workers across the country to leave the industry.”
“Such as the doctor typically filling this role in the joke,” the therapist, who is not licensed to prescribe medicine, nods.
“Exactly! And with so many respiratory viruses circulating and COVID still hanging around, emergency departments all over the country are facing massive backups. People are waiting outside the hospital for hours, hoping a bed will open up. Things got so bad at a hospital near Seattle in October that a nurse called 911 on her own ED. Told the 911 operator to send the fire department to help out, since they were ‘drowning’ and ‘in dire straits.’ They had 45 patients waiting and only five nurses to take care of them.”
“That is quite serious,” the therapist says, scribbling down unseen notes.
“The fire chief did send a crew out, and they cleaned rooms, changed beds, and took vitals for 90 minutes until the crisis passed,” the man says. “But it’s only a matter of time before it happens again. The hospital president said they have 300 open positions, and literally no one has applied to work in the emergency department. Not one person.”
“And how does all this make you feel?” the therapist asks.
“I feel all alone,” the man says. “This world feels so threatening, like no one cares, and I have no idea what will come next. It’s so vague and uncertain.”
“Ah, I think I have a solution for you,” the therapist says. “Go to the emergency department at St. Michael Medical Center in Silverdale, near Seattle. They’ll get your bad mood all settled, and they’ll prescribe you the medicine you need to relax.”
The man bursts into tears. “You don’t understand,” he says. “I am the emergency department at St. Michael Medical Center.”
Good joke. Everybody laugh. Roll on snare drum. Curtains.
Myth buster: Supplements for cholesterol lowering
When it comes to that nasty low-density lipoprotein cholesterol, some people swear by supplements over statins as a holistic approach. Well, we’re busting the myth that those heart-healthy supplements are even effective in comparison.
Which supplements are we talking about? These six are always on sale at the pharmacy: fish oil, cinnamon, garlic, turmeric, plant sterols, and red yeast rice.
In a study presented at the recent American Heart Association scientific sessions, researchers compared these supplements’ effectiveness in lowering LDL cholesterol with low-dose rosuvastatin or placebo among 199 adults aged 40-75 years who didn’t have a personal history of cardiovascular disease.
Participants who took the statin for 28 days had an average of 24% decrease in total cholesterol and a 38% reduction in LDL cholesterol, while 28 days’ worth of the supplements did no better than the placebo in either measure. Compared with placebo, the plant sterols supplement notably lowered HDL cholesterol and the garlic supplement notably increased LDL cholesterol.
Even though there are other studies showing the validity of plant sterols and red yeast rice to lower LDL cholesterol, author Luke J. Laffin, MD, of the Cleveland Clinic noted that this study shows how supplement results can vary and that more research is needed to see the effect they truly have on cholesterol over time.
So, should you stop taking or recommending supplements for heart health or healthy cholesterol levels? Well, we’re not going to come to your house and raid your medicine cabinet, but the authors of this study are definitely not saying that you should rely on them.
Consider this myth mostly busted.
COVID dept. of unintended consequences, part 2
The surveillance testing programs conducted in the first year of the pandemic were, in theory, meant to keep everyone safer. Someone, apparently, forgot to explain that to the students of the University of Wyoming and the University of Idaho.
We’re all familiar with the drill: Students at the two schools had to undergo frequent COVID screening to keep the virus from spreading, thereby making everyone safer. Duck your head now, because here comes the unintended consequence.
The students who didn’t get COVID eventually, and perhaps not so surprisingly, “perceived that the mandatory testing policy decreased their risk of contracting COVID-19, and … this perception led to higher participation in COVID-risky events,” Chian Jones Ritten, PhD, and associates said in PNAS Nexus.
They surveyed 757 students from the Univ. of Washington and 517 from the Univ. of Idaho and found that those who were tested more frequently perceived that they were less likely to contract the virus. Those respondents also more frequently attended indoor gatherings, both small and large, and spent more time in restaurants and bars.
The investigators did not mince words: “From a public health standpoint, such behavior is problematic.”
Current parents/participants in the workforce might have other ideas about an appropriate response to COVID.
At this point, we probably should mention that appropriation is the second-most sincere form of flattery.
Is opioid abuse leading to pediatric head trauma?
As a physician in the heart of the opioid epidemic, Pavirthra R. Ellison, MD, has watched for years as her patients have lost parents to overdoses. More than 1,400 adults in West Virginia, where she practices, died of opioid abuse in 2021 alone, government statistics show.
The grim toll made Ellison wonder: What was happening to children in the state? The answer, according to a new study, is not reassuring.
Ellison and her colleagues have found a troubling link between a surge in critical head and neck injuries among youth in West Virginia and a spike in positive tests for opioids and benzodiazepines among children who arrive at emergency departments in the state. They don’t think the pattern is a coincidence.
“What we found was really kind of scary,” said Dr. Ellison, a professor of anesthesiology and pediatrics at West Virginia University, Morgantown. “Children in this region often get exposure to these drugs early on.”
A region in crisis
According to a 2020 report from the Department of Health & Human Services, about 9.9 million Americans abused prescription opioids in 2018. That same year, almost 47,000 died following an overdose of the painkillers. In 2017, Appalachian counties experienced a death rate from opioid overdoses that was 72% higher than that of the rest of the country.
Dr. Ellison and associates who presented their findings recently at the 2022 annual meeting of the American Society of Anesthesiologists, examined rates of pediatric trauma injuries, injury severity, and results of drug screenings throughout West Virginia between 2009 and 2019.
The study included 4,538 children and adolescents younger than 18 years who had been treated for head and neck trauma. The youth were divided into two groups: 3,356 who were treated from 2009 to 2016, and 1,182 who were treated between 2017 and 2019.
The incidence of critical head injuries increased from 3.7% in the period 2009-2016 to 7.2% in the period 2017-2019 (P = .007). The incidence of serious neck injuries increased from 12.2% to 27.1% (P = .007) during that period, according to the researchers. The number of days that these patients spent on ventilators more than doubled, from 3.1 to 6.3 (P < .001), they reported.
At the same time, the rate of positive urine drug tests rose sharply, from 0.8% to 1.8% (P < .001) for benzodiazepines and from 1% to 4.9% for opioids (P < .001).
Drug testing of children hospitalized for trauma rose more than threefold, from 6.9% to 23.2% (P < .001). Dr. Ellison’s group was unable to match positive drug screens with patients who came in with injuries.
Dr. Ellison said her research “warrants further evaluation of current policies and protocols targeting substance use in children and adolescents.” To that end, her team is planning to conduct a prospective study in mid 2023 to further illuminate the trends.
“I hope early next year we can put together a group of physicians, pediatric general surgeons, neurosurgeons, and anesthesiologists,” she said. “I want to look at what we can do to reduce the severity of injury.”
She also wants to reach the population that these findings directly affect.
“The next step that we are currently working on is community awareness of the issue,” Dr. Ellison said. “Our trauma institute is partnering with middle school and high school kids to create material to raise awareness.”
Rural Appalachia faces several other endemic problems that affect the health and well-being of children and families, including limited access to health care, poverty, and minimal community support, according to Dr. Ellison. Children and teens in the region who live with parents who abuse opioids are more likely to experience family conflict, mental health challenges, legal troubles, and negative health effects, including physical trauma.
A call to action
Toufic Jildeh, MD, assistant professor of orthopedics, Michigan State University Health Care, East Lansing, who has studied ways to reduce opioid use among surgery patients, called the new findings “alarming.”
After reviewing the study, Dr. Jildeh said that in his opinion, the results support standardized drug testing of children, particularly in the context of severe trauma.
Bruce Bassi, MD, an addiction psychiatrist and owner of TelepsychHealth, a private, online psychiatric practice, agreed. “The main take-home message is that drug screening should be the standard of care for pediatric patients in this region, because it changes the management of those individuals,” Dr. Bassi said.
But identifying these patients is just the first step. “We should continue to educate and raise awareness, not only in the health care system,” Dr. Bassi said. “We also need to let parents know that the possibility of children obtaining access to medications is high.”
The study was independently supported. Dr. Ellison and Dr. Jildeh reported no relevant financial relationships. Dr. Bassi owns a private psychiatry practice called Telepsychhealth but has no other relevant financial relationships.
A version of this article first appeared on Medscape.com.
As a physician in the heart of the opioid epidemic, Pavirthra R. Ellison, MD, has watched for years as her patients have lost parents to overdoses. More than 1,400 adults in West Virginia, where she practices, died of opioid abuse in 2021 alone, government statistics show.
The grim toll made Ellison wonder: What was happening to children in the state? The answer, according to a new study, is not reassuring.
Ellison and her colleagues have found a troubling link between a surge in critical head and neck injuries among youth in West Virginia and a spike in positive tests for opioids and benzodiazepines among children who arrive at emergency departments in the state. They don’t think the pattern is a coincidence.
“What we found was really kind of scary,” said Dr. Ellison, a professor of anesthesiology and pediatrics at West Virginia University, Morgantown. “Children in this region often get exposure to these drugs early on.”
A region in crisis
According to a 2020 report from the Department of Health & Human Services, about 9.9 million Americans abused prescription opioids in 2018. That same year, almost 47,000 died following an overdose of the painkillers. In 2017, Appalachian counties experienced a death rate from opioid overdoses that was 72% higher than that of the rest of the country.
Dr. Ellison and associates who presented their findings recently at the 2022 annual meeting of the American Society of Anesthesiologists, examined rates of pediatric trauma injuries, injury severity, and results of drug screenings throughout West Virginia between 2009 and 2019.
The study included 4,538 children and adolescents younger than 18 years who had been treated for head and neck trauma. The youth were divided into two groups: 3,356 who were treated from 2009 to 2016, and 1,182 who were treated between 2017 and 2019.
The incidence of critical head injuries increased from 3.7% in the period 2009-2016 to 7.2% in the period 2017-2019 (P = .007). The incidence of serious neck injuries increased from 12.2% to 27.1% (P = .007) during that period, according to the researchers. The number of days that these patients spent on ventilators more than doubled, from 3.1 to 6.3 (P < .001), they reported.
At the same time, the rate of positive urine drug tests rose sharply, from 0.8% to 1.8% (P < .001) for benzodiazepines and from 1% to 4.9% for opioids (P < .001).
Drug testing of children hospitalized for trauma rose more than threefold, from 6.9% to 23.2% (P < .001). Dr. Ellison’s group was unable to match positive drug screens with patients who came in with injuries.
Dr. Ellison said her research “warrants further evaluation of current policies and protocols targeting substance use in children and adolescents.” To that end, her team is planning to conduct a prospective study in mid 2023 to further illuminate the trends.
“I hope early next year we can put together a group of physicians, pediatric general surgeons, neurosurgeons, and anesthesiologists,” she said. “I want to look at what we can do to reduce the severity of injury.”
She also wants to reach the population that these findings directly affect.
“The next step that we are currently working on is community awareness of the issue,” Dr. Ellison said. “Our trauma institute is partnering with middle school and high school kids to create material to raise awareness.”
Rural Appalachia faces several other endemic problems that affect the health and well-being of children and families, including limited access to health care, poverty, and minimal community support, according to Dr. Ellison. Children and teens in the region who live with parents who abuse opioids are more likely to experience family conflict, mental health challenges, legal troubles, and negative health effects, including physical trauma.
A call to action
Toufic Jildeh, MD, assistant professor of orthopedics, Michigan State University Health Care, East Lansing, who has studied ways to reduce opioid use among surgery patients, called the new findings “alarming.”
After reviewing the study, Dr. Jildeh said that in his opinion, the results support standardized drug testing of children, particularly in the context of severe trauma.
Bruce Bassi, MD, an addiction psychiatrist and owner of TelepsychHealth, a private, online psychiatric practice, agreed. “The main take-home message is that drug screening should be the standard of care for pediatric patients in this region, because it changes the management of those individuals,” Dr. Bassi said.
But identifying these patients is just the first step. “We should continue to educate and raise awareness, not only in the health care system,” Dr. Bassi said. “We also need to let parents know that the possibility of children obtaining access to medications is high.”
The study was independently supported. Dr. Ellison and Dr. Jildeh reported no relevant financial relationships. Dr. Bassi owns a private psychiatry practice called Telepsychhealth but has no other relevant financial relationships.
A version of this article first appeared on Medscape.com.
As a physician in the heart of the opioid epidemic, Pavirthra R. Ellison, MD, has watched for years as her patients have lost parents to overdoses. More than 1,400 adults in West Virginia, where she practices, died of opioid abuse in 2021 alone, government statistics show.
The grim toll made Ellison wonder: What was happening to children in the state? The answer, according to a new study, is not reassuring.
Ellison and her colleagues have found a troubling link between a surge in critical head and neck injuries among youth in West Virginia and a spike in positive tests for opioids and benzodiazepines among children who arrive at emergency departments in the state. They don’t think the pattern is a coincidence.
“What we found was really kind of scary,” said Dr. Ellison, a professor of anesthesiology and pediatrics at West Virginia University, Morgantown. “Children in this region often get exposure to these drugs early on.”
A region in crisis
According to a 2020 report from the Department of Health & Human Services, about 9.9 million Americans abused prescription opioids in 2018. That same year, almost 47,000 died following an overdose of the painkillers. In 2017, Appalachian counties experienced a death rate from opioid overdoses that was 72% higher than that of the rest of the country.
Dr. Ellison and associates who presented their findings recently at the 2022 annual meeting of the American Society of Anesthesiologists, examined rates of pediatric trauma injuries, injury severity, and results of drug screenings throughout West Virginia between 2009 and 2019.
The study included 4,538 children and adolescents younger than 18 years who had been treated for head and neck trauma. The youth were divided into two groups: 3,356 who were treated from 2009 to 2016, and 1,182 who were treated between 2017 and 2019.
The incidence of critical head injuries increased from 3.7% in the period 2009-2016 to 7.2% in the period 2017-2019 (P = .007). The incidence of serious neck injuries increased from 12.2% to 27.1% (P = .007) during that period, according to the researchers. The number of days that these patients spent on ventilators more than doubled, from 3.1 to 6.3 (P < .001), they reported.
At the same time, the rate of positive urine drug tests rose sharply, from 0.8% to 1.8% (P < .001) for benzodiazepines and from 1% to 4.9% for opioids (P < .001).
Drug testing of children hospitalized for trauma rose more than threefold, from 6.9% to 23.2% (P < .001). Dr. Ellison’s group was unable to match positive drug screens with patients who came in with injuries.
Dr. Ellison said her research “warrants further evaluation of current policies and protocols targeting substance use in children and adolescents.” To that end, her team is planning to conduct a prospective study in mid 2023 to further illuminate the trends.
“I hope early next year we can put together a group of physicians, pediatric general surgeons, neurosurgeons, and anesthesiologists,” she said. “I want to look at what we can do to reduce the severity of injury.”
She also wants to reach the population that these findings directly affect.
“The next step that we are currently working on is community awareness of the issue,” Dr. Ellison said. “Our trauma institute is partnering with middle school and high school kids to create material to raise awareness.”
Rural Appalachia faces several other endemic problems that affect the health and well-being of children and families, including limited access to health care, poverty, and minimal community support, according to Dr. Ellison. Children and teens in the region who live with parents who abuse opioids are more likely to experience family conflict, mental health challenges, legal troubles, and negative health effects, including physical trauma.
A call to action
Toufic Jildeh, MD, assistant professor of orthopedics, Michigan State University Health Care, East Lansing, who has studied ways to reduce opioid use among surgery patients, called the new findings “alarming.”
After reviewing the study, Dr. Jildeh said that in his opinion, the results support standardized drug testing of children, particularly in the context of severe trauma.
Bruce Bassi, MD, an addiction psychiatrist and owner of TelepsychHealth, a private, online psychiatric practice, agreed. “The main take-home message is that drug screening should be the standard of care for pediatric patients in this region, because it changes the management of those individuals,” Dr. Bassi said.
But identifying these patients is just the first step. “We should continue to educate and raise awareness, not only in the health care system,” Dr. Bassi said. “We also need to let parents know that the possibility of children obtaining access to medications is high.”
The study was independently supported. Dr. Ellison and Dr. Jildeh reported no relevant financial relationships. Dr. Bassi owns a private psychiatry practice called Telepsychhealth but has no other relevant financial relationships.
A version of this article first appeared on Medscape.com.
Physicians react: Climate change and other social issues
Around half of them rated climate change among their five most important issues. Slightly lower percentages of doctors prioritized domestic violence and immigration/refugee policies that highly, and about 40% did so regarding reproductive rights in the United States.
Survey responses and comments left on the Physicians’ Views on Today’s Divisive Social Issues 2022 report provide insights into doctors’ attitudes and thinking about these four social challenges.
Relevance of climate change to health care
In the Medscape report, 61% of physicians described themselves as “very concerned” or “concerned” about climate change, and about 7 in 10 agreed with the statement that it should be a top worldwide priority. “Climate change is the most pressing issue of this century,” a psychiatrist respondent wrote.
What about direct effects on patients’ health? An internist worried that rising temperatures will cause “pathogens to spread and infect disadvantaged people who do not have health access and have immunocompromised conditions.” A family medicine physician predicted “more weather disasters, more asthma, more hormonal changes, and more obesity.”
However, physician viewpoints ran the gamut with an issue that has become politically and emotionally charged. Descriptions such as “overblown,” “hysteria,” “hoax,” and “farce” were used. “Climate change is a natural phenomenon under God’s purview,” an emergency medicine physician said.
And there was some middle-ground thinking. “It’s overstated but quite real,” a pediatrician respondent wrote. Added an ophthalmologist: “It has gone on for ages. We must work to decrease man-made conditions that affect climate change, but it must be done in an intelligent fashion.”
Domestic violence: What physicians can do
About 7 in 10 physicians surveyed by Medscape said they don’t think the United States is adequately tackling domestic violence. “It is underrecognized and ignored,” a psychiatrist respondent argued. The problem is “rampant and unacceptable, pushed into a closet and normalized, with associated shame,” an emergency medicine doctor wrote.
Many respondents noted that physicians are under a mandate to report abuse of or a suspicious injury to a patient. Some shared anecdotes about how they reported action they had taken when they suspected it. “I’ve told patients who may be in dangerous situations that I’m a safe person and provide a safe space,” a radiologist added. An internist said, “I’ve recently started to ask about safety at home during triage on every patient.”
Other doctors bemoaned a lack of adequate education on detecting and managing domestic violence and abuse. “Domestic violence is often not recognized by health care providers,” a psychiatrist respondent observed.
Expanding legal immigration
In the Medscape report, 34% of physicians felt U.S. immigration/refugee policies need to be tougher, while 28% said they are too restrictive, and about a fifth saw them as appropriate.
“As an immigrant, I can tell you that the system is flawed and needs a complete overhaul, which will take a bipartisan effort,” an endocrinologist respondent wrote.
A number of respondents argued that it’s critical to simplify the process of obtaining U.S. citizenship so that fewer will feel forced to enter the country illegally. “For a country that relies very heavily on immigrants to sustain our health care system, we behave like idiots in denying safe harbor,” a nephrologist asserted.
A neurologist concurred. “Legal immigration needs to be encouraged. It should be easier to exchange visitor or student visa to immigrant visa in order to retain talent in the health care and technology fields, which would alleviate the shortage of workers in health care.”
Reproductive rights: No easy answers
Medscape’s survey was conducted before the U.S. Supreme Court in June reversed Roe v. Wade. In the report, 71% of physicians described themselves as very to somewhat concerned about women’s reproductive rights, but their viewpoints became nuanced after that. “There is a big disparity among physicians on this topic,” an oncologist respondent wrote.
At one end of the spectrum, 3% of doctors felt that abortions should never be permitted. “The human baby in the womb is an independent person with the right to life,” a pathologist said. At the other end, nearly one-fourth of physicians believed abortion should be accessible under all circumstances, regardless of trimester or reason. “I am just here to support the woman and make her decision a reality,” an internist said.
While saying an abortion should be granted after “fetal viability” only “in extenuating circumstances,” an ob.gyn. respondent said she is “extremely concerned” about attacks on abortion rights. “Some of us are old enough to remember women coming to the ER in extremis after illegal procedures, prior to Roe v. Wade.”
A version of this article first appeared on Medscape.com.
Around half of them rated climate change among their five most important issues. Slightly lower percentages of doctors prioritized domestic violence and immigration/refugee policies that highly, and about 40% did so regarding reproductive rights in the United States.
Survey responses and comments left on the Physicians’ Views on Today’s Divisive Social Issues 2022 report provide insights into doctors’ attitudes and thinking about these four social challenges.
Relevance of climate change to health care
In the Medscape report, 61% of physicians described themselves as “very concerned” or “concerned” about climate change, and about 7 in 10 agreed with the statement that it should be a top worldwide priority. “Climate change is the most pressing issue of this century,” a psychiatrist respondent wrote.
What about direct effects on patients’ health? An internist worried that rising temperatures will cause “pathogens to spread and infect disadvantaged people who do not have health access and have immunocompromised conditions.” A family medicine physician predicted “more weather disasters, more asthma, more hormonal changes, and more obesity.”
However, physician viewpoints ran the gamut with an issue that has become politically and emotionally charged. Descriptions such as “overblown,” “hysteria,” “hoax,” and “farce” were used. “Climate change is a natural phenomenon under God’s purview,” an emergency medicine physician said.
And there was some middle-ground thinking. “It’s overstated but quite real,” a pediatrician respondent wrote. Added an ophthalmologist: “It has gone on for ages. We must work to decrease man-made conditions that affect climate change, but it must be done in an intelligent fashion.”
Domestic violence: What physicians can do
About 7 in 10 physicians surveyed by Medscape said they don’t think the United States is adequately tackling domestic violence. “It is underrecognized and ignored,” a psychiatrist respondent argued. The problem is “rampant and unacceptable, pushed into a closet and normalized, with associated shame,” an emergency medicine doctor wrote.
Many respondents noted that physicians are under a mandate to report abuse of or a suspicious injury to a patient. Some shared anecdotes about how they reported action they had taken when they suspected it. “I’ve told patients who may be in dangerous situations that I’m a safe person and provide a safe space,” a radiologist added. An internist said, “I’ve recently started to ask about safety at home during triage on every patient.”
Other doctors bemoaned a lack of adequate education on detecting and managing domestic violence and abuse. “Domestic violence is often not recognized by health care providers,” a psychiatrist respondent observed.
Expanding legal immigration
In the Medscape report, 34% of physicians felt U.S. immigration/refugee policies need to be tougher, while 28% said they are too restrictive, and about a fifth saw them as appropriate.
“As an immigrant, I can tell you that the system is flawed and needs a complete overhaul, which will take a bipartisan effort,” an endocrinologist respondent wrote.
A number of respondents argued that it’s critical to simplify the process of obtaining U.S. citizenship so that fewer will feel forced to enter the country illegally. “For a country that relies very heavily on immigrants to sustain our health care system, we behave like idiots in denying safe harbor,” a nephrologist asserted.
A neurologist concurred. “Legal immigration needs to be encouraged. It should be easier to exchange visitor or student visa to immigrant visa in order to retain talent in the health care and technology fields, which would alleviate the shortage of workers in health care.”
Reproductive rights: No easy answers
Medscape’s survey was conducted before the U.S. Supreme Court in June reversed Roe v. Wade. In the report, 71% of physicians described themselves as very to somewhat concerned about women’s reproductive rights, but their viewpoints became nuanced after that. “There is a big disparity among physicians on this topic,” an oncologist respondent wrote.
At one end of the spectrum, 3% of doctors felt that abortions should never be permitted. “The human baby in the womb is an independent person with the right to life,” a pathologist said. At the other end, nearly one-fourth of physicians believed abortion should be accessible under all circumstances, regardless of trimester or reason. “I am just here to support the woman and make her decision a reality,” an internist said.
While saying an abortion should be granted after “fetal viability” only “in extenuating circumstances,” an ob.gyn. respondent said she is “extremely concerned” about attacks on abortion rights. “Some of us are old enough to remember women coming to the ER in extremis after illegal procedures, prior to Roe v. Wade.”
A version of this article first appeared on Medscape.com.
Around half of them rated climate change among their five most important issues. Slightly lower percentages of doctors prioritized domestic violence and immigration/refugee policies that highly, and about 40% did so regarding reproductive rights in the United States.
Survey responses and comments left on the Physicians’ Views on Today’s Divisive Social Issues 2022 report provide insights into doctors’ attitudes and thinking about these four social challenges.
Relevance of climate change to health care
In the Medscape report, 61% of physicians described themselves as “very concerned” or “concerned” about climate change, and about 7 in 10 agreed with the statement that it should be a top worldwide priority. “Climate change is the most pressing issue of this century,” a psychiatrist respondent wrote.
What about direct effects on patients’ health? An internist worried that rising temperatures will cause “pathogens to spread and infect disadvantaged people who do not have health access and have immunocompromised conditions.” A family medicine physician predicted “more weather disasters, more asthma, more hormonal changes, and more obesity.”
However, physician viewpoints ran the gamut with an issue that has become politically and emotionally charged. Descriptions such as “overblown,” “hysteria,” “hoax,” and “farce” were used. “Climate change is a natural phenomenon under God’s purview,” an emergency medicine physician said.
And there was some middle-ground thinking. “It’s overstated but quite real,” a pediatrician respondent wrote. Added an ophthalmologist: “It has gone on for ages. We must work to decrease man-made conditions that affect climate change, but it must be done in an intelligent fashion.”
Domestic violence: What physicians can do
About 7 in 10 physicians surveyed by Medscape said they don’t think the United States is adequately tackling domestic violence. “It is underrecognized and ignored,” a psychiatrist respondent argued. The problem is “rampant and unacceptable, pushed into a closet and normalized, with associated shame,” an emergency medicine doctor wrote.
Many respondents noted that physicians are under a mandate to report abuse of or a suspicious injury to a patient. Some shared anecdotes about how they reported action they had taken when they suspected it. “I’ve told patients who may be in dangerous situations that I’m a safe person and provide a safe space,” a radiologist added. An internist said, “I’ve recently started to ask about safety at home during triage on every patient.”
Other doctors bemoaned a lack of adequate education on detecting and managing domestic violence and abuse. “Domestic violence is often not recognized by health care providers,” a psychiatrist respondent observed.
Expanding legal immigration
In the Medscape report, 34% of physicians felt U.S. immigration/refugee policies need to be tougher, while 28% said they are too restrictive, and about a fifth saw them as appropriate.
“As an immigrant, I can tell you that the system is flawed and needs a complete overhaul, which will take a bipartisan effort,” an endocrinologist respondent wrote.
A number of respondents argued that it’s critical to simplify the process of obtaining U.S. citizenship so that fewer will feel forced to enter the country illegally. “For a country that relies very heavily on immigrants to sustain our health care system, we behave like idiots in denying safe harbor,” a nephrologist asserted.
A neurologist concurred. “Legal immigration needs to be encouraged. It should be easier to exchange visitor or student visa to immigrant visa in order to retain talent in the health care and technology fields, which would alleviate the shortage of workers in health care.”
Reproductive rights: No easy answers
Medscape’s survey was conducted before the U.S. Supreme Court in June reversed Roe v. Wade. In the report, 71% of physicians described themselves as very to somewhat concerned about women’s reproductive rights, but their viewpoints became nuanced after that. “There is a big disparity among physicians on this topic,” an oncologist respondent wrote.
At one end of the spectrum, 3% of doctors felt that abortions should never be permitted. “The human baby in the womb is an independent person with the right to life,” a pathologist said. At the other end, nearly one-fourth of physicians believed abortion should be accessible under all circumstances, regardless of trimester or reason. “I am just here to support the woman and make her decision a reality,” an internist said.
While saying an abortion should be granted after “fetal viability” only “in extenuating circumstances,” an ob.gyn. respondent said she is “extremely concerned” about attacks on abortion rights. “Some of us are old enough to remember women coming to the ER in extremis after illegal procedures, prior to Roe v. Wade.”
A version of this article first appeared on Medscape.com.
The danger when doctors don’t get mental health help
As medical professionals, you’re continually exposed to overwork, burnout, stressful situations, and challenging ethical decisions. Yet seeking help for mental health care may be last on your to-do list – or completely off your radar.
That’s sad and dangerous, since the American College of Emergency Physicians said 300-400 physicians die by suicide each year, and the stigma keeps 69% of female physicians from seeking mental health care, according to a prepandemic study.
In the 2022 Medscape Physician Suicide Report, 11% of female doctors and 9% of male doctors said they have had thoughts of suicide, and 64% experienced colloquial depression (feeling down, sad, or blue).
What’s more, physicians are typically seen as strong and capable and are often put on a pedestal by loved ones, patients, and the public and thought of as superhuman. No wonder it isn’t easy when you need to take time away to decompress and treat your mental well-being.
“There is a real fear for physicians when it comes to getting mental health care,” said Emil Tsai, MD, PhD, MAS, professor at the department of psychiatry and behavioral sciences at the University of California, Los Angeles, and an internationally reputed scientist in neurosciences and brain disorders.
The fear, said Dr. Tsai, comes from the stigma of mental health issues, potential repercussions to employment, and conceivable medical board suspension or revocation of your medical license.
Dr. Tsai said in an interview that to combat anxiety about “punishment” that many physicians fear when seeking care for their mental health, we must allow physicians to take time away from their day-to-day patient care for respite and treatment without reprisal.
Since the medical profession is high stress and has a high depression and suicide rate, finding solutions is imperative. And physicians must feel supported enough to seek treatment when needed. So how can we normalize seeking mental health care among physicians?
Get honest about stress and burnout
The only way to normalize any behavior is to be open and candid, Dr. Tsai said in an interview. The mental health conversation must occur across the board, not just within the medical profession.
“The greatest thing we can do to try and lift the burden that we place on physicians is to be willing to talk and be honest about the stress that physicians deal with and the importance of everyone feeling free to seek treatment and rest to strengthen their mental health,” said Dr. Tsai.
The more we talk about mental health and its treatment, the more we lessen the stigma, said Dr. Tsai. That could be more employer-employee check-ins, counseling as part of physician wellness, and programs structured so as not to construe a penal system.
“Mental health in the medical profession is a big issue and one that has to be met with the same compassion and care as it should be for any patient. We have annual physical checkups. Why don’t we offer annual mental health checkups for all, physicians included?” asked Dr. Tsai.
Evaluate the workload
Elizabeth Lombardo, PhD, psychologist, coach, and global keynote speaker, thinks that health care employers should reexamine their physicians’ workloads to see if they’re contributing to mental health issues.
The conversation on mental health in the workplace shouldn’t be about whether a certain person can handle stressors that are “normal” for health care settings. Instead, workplace managers in health care institutions should redefine workloads to ensure that physicians aren’t too heavily burdened with responsibilities that can cause overwork, burnout, and mental health problems,” she said.
Lessen the stigma
Even when physicians want to seek help for their psychological struggles, they may be weary of how their colleagues would react if they knew.
Raffaello Antonino, MD, clinical director at Therapy Central in London, said several underlying fears may exist at a physician’s core that prevent them from seeking care – being seen as weak, being judged as unfit to practice medicine, and the notion that “something is wrong with them.”
Dr. Antonino said we need to understand that physicians face challenges of bereavement and trauma derived from losing patients and the inability to save someone’s life. “These issues can easily develop into an accumulation of difficult, unprocessed emotions, later arising in symptoms and signs of PTSD, anxiety, and depression.”
Education is the best way to end this stigma, just like with any form of prejudice and stereotypes. For instance, we know that health care professionals are at risk of developing burnout. So, educating physicians on the symptoms and management of burnout and its consequences and prevention strategies is a must.
“Imagine what could happen if there were regular opportunities to work through the day’s events before signing out from a shift. The idea that individual weekly therapy is the only way to relieve mental distress is false,” said Lori McIsaac Bewsher, MSW, RSW, a trauma therapist and owner of a trauma-focused mental health clinic in New Brunswick.
“There are ways of integrating individual care into our doctor’s offices and hospitals that can be brief, effective, and confidential. The best way to introduce these interventions is early and collectively; no one is immune to the potential impact of exposure to trauma. The earlier these interventions can be accessed, the better the outcomes for everyone,” she said.
Dr. Antonino suggests, perhaps in the future, organizations can have “burnout checks” or mental health wellness checks for physicians akin to how we also have quick examinations for various physical ailments. What if physicians regularly answered a 10-question mental health survey as part of a burnout or trauma prevention strategy?
“Theirs is a profession and an identity which is often linked with a sense of strength, leadership and [benevolent] power: adjectives, which on the surface one might see as incompatible with what instead, unfortunately, and wrongly, may be associated with mental health issues,” said Dr. Antonino.
Keep it private
When it comes to removing the stigma from mental health care and treatment for physicians, privacy is top of mind. There needs to be some form of privacy protection for physicians who seek professional help for mental health reasons. Dr. Lombardo said physicians need to have the choice to keep their mental health journeys private. “Ideally, normalization should mean openly conversing about mental health, but for physicians, it can be a matter of life or death for their career, so the choice to remain private is something that should be afforded to them.”
Along those lines, the American Medical Association is pushing for system changes in legislative and regulatory arenas to support the mental health of practicing physicians, residents, and medical students. The organization is also urging health systems and state medical licensing bodies to remove questions on their applications that ask about prior treatment for mental health conditions.
Among many programs across the country, the Foundation of the Pennsylvania Medical Society has also created a Physicians’ Health Program, which provides confidential assessment, counseling, and referral services for physicians with mental health concerns.
“All of these initiatives are important in helping to destigmatize mental health issues among physicians,” said Harold Hong, MD, a board-certified psychiatrist in Raleigh, N.C.
Hail the benefits of treatment
Dr. Hong said to continue to destigmatize mental health among physicians and normalize its treatment, we not only have to emphasize how attending to mental health has individual benefits but also how it helps us help our patients.
“One key aspect that perhaps underpins this issue is the still present separation between mental and physical health, between mind and body, Dr. Hong said in an interview. “Feeling sad or angry or anxious should become a fact of life, a characteristic of being human, just like catching a cold or breaking a leg.”
It’s a normalization that, perhaps more than anything else, can lead the way for improving physicians’ mental health outcomes while also improving them for the rest of society. When society can finally see the health and well-being of someone in both their psychological and physical status, some of the stigmas may dissipate, and perhaps more physicians’ lives can be saved.
A version of this article first appeared on Medscape.com.
As medical professionals, you’re continually exposed to overwork, burnout, stressful situations, and challenging ethical decisions. Yet seeking help for mental health care may be last on your to-do list – or completely off your radar.
That’s sad and dangerous, since the American College of Emergency Physicians said 300-400 physicians die by suicide each year, and the stigma keeps 69% of female physicians from seeking mental health care, according to a prepandemic study.
In the 2022 Medscape Physician Suicide Report, 11% of female doctors and 9% of male doctors said they have had thoughts of suicide, and 64% experienced colloquial depression (feeling down, sad, or blue).
What’s more, physicians are typically seen as strong and capable and are often put on a pedestal by loved ones, patients, and the public and thought of as superhuman. No wonder it isn’t easy when you need to take time away to decompress and treat your mental well-being.
“There is a real fear for physicians when it comes to getting mental health care,” said Emil Tsai, MD, PhD, MAS, professor at the department of psychiatry and behavioral sciences at the University of California, Los Angeles, and an internationally reputed scientist in neurosciences and brain disorders.
The fear, said Dr. Tsai, comes from the stigma of mental health issues, potential repercussions to employment, and conceivable medical board suspension or revocation of your medical license.
Dr. Tsai said in an interview that to combat anxiety about “punishment” that many physicians fear when seeking care for their mental health, we must allow physicians to take time away from their day-to-day patient care for respite and treatment without reprisal.
Since the medical profession is high stress and has a high depression and suicide rate, finding solutions is imperative. And physicians must feel supported enough to seek treatment when needed. So how can we normalize seeking mental health care among physicians?
Get honest about stress and burnout
The only way to normalize any behavior is to be open and candid, Dr. Tsai said in an interview. The mental health conversation must occur across the board, not just within the medical profession.
“The greatest thing we can do to try and lift the burden that we place on physicians is to be willing to talk and be honest about the stress that physicians deal with and the importance of everyone feeling free to seek treatment and rest to strengthen their mental health,” said Dr. Tsai.
The more we talk about mental health and its treatment, the more we lessen the stigma, said Dr. Tsai. That could be more employer-employee check-ins, counseling as part of physician wellness, and programs structured so as not to construe a penal system.
“Mental health in the medical profession is a big issue and one that has to be met with the same compassion and care as it should be for any patient. We have annual physical checkups. Why don’t we offer annual mental health checkups for all, physicians included?” asked Dr. Tsai.
Evaluate the workload
Elizabeth Lombardo, PhD, psychologist, coach, and global keynote speaker, thinks that health care employers should reexamine their physicians’ workloads to see if they’re contributing to mental health issues.
The conversation on mental health in the workplace shouldn’t be about whether a certain person can handle stressors that are “normal” for health care settings. Instead, workplace managers in health care institutions should redefine workloads to ensure that physicians aren’t too heavily burdened with responsibilities that can cause overwork, burnout, and mental health problems,” she said.
Lessen the stigma
Even when physicians want to seek help for their psychological struggles, they may be weary of how their colleagues would react if they knew.
Raffaello Antonino, MD, clinical director at Therapy Central in London, said several underlying fears may exist at a physician’s core that prevent them from seeking care – being seen as weak, being judged as unfit to practice medicine, and the notion that “something is wrong with them.”
Dr. Antonino said we need to understand that physicians face challenges of bereavement and trauma derived from losing patients and the inability to save someone’s life. “These issues can easily develop into an accumulation of difficult, unprocessed emotions, later arising in symptoms and signs of PTSD, anxiety, and depression.”
Education is the best way to end this stigma, just like with any form of prejudice and stereotypes. For instance, we know that health care professionals are at risk of developing burnout. So, educating physicians on the symptoms and management of burnout and its consequences and prevention strategies is a must.
“Imagine what could happen if there were regular opportunities to work through the day’s events before signing out from a shift. The idea that individual weekly therapy is the only way to relieve mental distress is false,” said Lori McIsaac Bewsher, MSW, RSW, a trauma therapist and owner of a trauma-focused mental health clinic in New Brunswick.
“There are ways of integrating individual care into our doctor’s offices and hospitals that can be brief, effective, and confidential. The best way to introduce these interventions is early and collectively; no one is immune to the potential impact of exposure to trauma. The earlier these interventions can be accessed, the better the outcomes for everyone,” she said.
Dr. Antonino suggests, perhaps in the future, organizations can have “burnout checks” or mental health wellness checks for physicians akin to how we also have quick examinations for various physical ailments. What if physicians regularly answered a 10-question mental health survey as part of a burnout or trauma prevention strategy?
“Theirs is a profession and an identity which is often linked with a sense of strength, leadership and [benevolent] power: adjectives, which on the surface one might see as incompatible with what instead, unfortunately, and wrongly, may be associated with mental health issues,” said Dr. Antonino.
Keep it private
When it comes to removing the stigma from mental health care and treatment for physicians, privacy is top of mind. There needs to be some form of privacy protection for physicians who seek professional help for mental health reasons. Dr. Lombardo said physicians need to have the choice to keep their mental health journeys private. “Ideally, normalization should mean openly conversing about mental health, but for physicians, it can be a matter of life or death for their career, so the choice to remain private is something that should be afforded to them.”
Along those lines, the American Medical Association is pushing for system changes in legislative and regulatory arenas to support the mental health of practicing physicians, residents, and medical students. The organization is also urging health systems and state medical licensing bodies to remove questions on their applications that ask about prior treatment for mental health conditions.
Among many programs across the country, the Foundation of the Pennsylvania Medical Society has also created a Physicians’ Health Program, which provides confidential assessment, counseling, and referral services for physicians with mental health concerns.
“All of these initiatives are important in helping to destigmatize mental health issues among physicians,” said Harold Hong, MD, a board-certified psychiatrist in Raleigh, N.C.
Hail the benefits of treatment
Dr. Hong said to continue to destigmatize mental health among physicians and normalize its treatment, we not only have to emphasize how attending to mental health has individual benefits but also how it helps us help our patients.
“One key aspect that perhaps underpins this issue is the still present separation between mental and physical health, between mind and body, Dr. Hong said in an interview. “Feeling sad or angry or anxious should become a fact of life, a characteristic of being human, just like catching a cold or breaking a leg.”
It’s a normalization that, perhaps more than anything else, can lead the way for improving physicians’ mental health outcomes while also improving them for the rest of society. When society can finally see the health and well-being of someone in both their psychological and physical status, some of the stigmas may dissipate, and perhaps more physicians’ lives can be saved.
A version of this article first appeared on Medscape.com.
As medical professionals, you’re continually exposed to overwork, burnout, stressful situations, and challenging ethical decisions. Yet seeking help for mental health care may be last on your to-do list – or completely off your radar.
That’s sad and dangerous, since the American College of Emergency Physicians said 300-400 physicians die by suicide each year, and the stigma keeps 69% of female physicians from seeking mental health care, according to a prepandemic study.
In the 2022 Medscape Physician Suicide Report, 11% of female doctors and 9% of male doctors said they have had thoughts of suicide, and 64% experienced colloquial depression (feeling down, sad, or blue).
What’s more, physicians are typically seen as strong and capable and are often put on a pedestal by loved ones, patients, and the public and thought of as superhuman. No wonder it isn’t easy when you need to take time away to decompress and treat your mental well-being.
“There is a real fear for physicians when it comes to getting mental health care,” said Emil Tsai, MD, PhD, MAS, professor at the department of psychiatry and behavioral sciences at the University of California, Los Angeles, and an internationally reputed scientist in neurosciences and brain disorders.
The fear, said Dr. Tsai, comes from the stigma of mental health issues, potential repercussions to employment, and conceivable medical board suspension or revocation of your medical license.
Dr. Tsai said in an interview that to combat anxiety about “punishment” that many physicians fear when seeking care for their mental health, we must allow physicians to take time away from their day-to-day patient care for respite and treatment without reprisal.
Since the medical profession is high stress and has a high depression and suicide rate, finding solutions is imperative. And physicians must feel supported enough to seek treatment when needed. So how can we normalize seeking mental health care among physicians?
Get honest about stress and burnout
The only way to normalize any behavior is to be open and candid, Dr. Tsai said in an interview. The mental health conversation must occur across the board, not just within the medical profession.
“The greatest thing we can do to try and lift the burden that we place on physicians is to be willing to talk and be honest about the stress that physicians deal with and the importance of everyone feeling free to seek treatment and rest to strengthen their mental health,” said Dr. Tsai.
The more we talk about mental health and its treatment, the more we lessen the stigma, said Dr. Tsai. That could be more employer-employee check-ins, counseling as part of physician wellness, and programs structured so as not to construe a penal system.
“Mental health in the medical profession is a big issue and one that has to be met with the same compassion and care as it should be for any patient. We have annual physical checkups. Why don’t we offer annual mental health checkups for all, physicians included?” asked Dr. Tsai.
Evaluate the workload
Elizabeth Lombardo, PhD, psychologist, coach, and global keynote speaker, thinks that health care employers should reexamine their physicians’ workloads to see if they’re contributing to mental health issues.
The conversation on mental health in the workplace shouldn’t be about whether a certain person can handle stressors that are “normal” for health care settings. Instead, workplace managers in health care institutions should redefine workloads to ensure that physicians aren’t too heavily burdened with responsibilities that can cause overwork, burnout, and mental health problems,” she said.
Lessen the stigma
Even when physicians want to seek help for their psychological struggles, they may be weary of how their colleagues would react if they knew.
Raffaello Antonino, MD, clinical director at Therapy Central in London, said several underlying fears may exist at a physician’s core that prevent them from seeking care – being seen as weak, being judged as unfit to practice medicine, and the notion that “something is wrong with them.”
Dr. Antonino said we need to understand that physicians face challenges of bereavement and trauma derived from losing patients and the inability to save someone’s life. “These issues can easily develop into an accumulation of difficult, unprocessed emotions, later arising in symptoms and signs of PTSD, anxiety, and depression.”
Education is the best way to end this stigma, just like with any form of prejudice and stereotypes. For instance, we know that health care professionals are at risk of developing burnout. So, educating physicians on the symptoms and management of burnout and its consequences and prevention strategies is a must.
“Imagine what could happen if there were regular opportunities to work through the day’s events before signing out from a shift. The idea that individual weekly therapy is the only way to relieve mental distress is false,” said Lori McIsaac Bewsher, MSW, RSW, a trauma therapist and owner of a trauma-focused mental health clinic in New Brunswick.
“There are ways of integrating individual care into our doctor’s offices and hospitals that can be brief, effective, and confidential. The best way to introduce these interventions is early and collectively; no one is immune to the potential impact of exposure to trauma. The earlier these interventions can be accessed, the better the outcomes for everyone,” she said.
Dr. Antonino suggests, perhaps in the future, organizations can have “burnout checks” or mental health wellness checks for physicians akin to how we also have quick examinations for various physical ailments. What if physicians regularly answered a 10-question mental health survey as part of a burnout or trauma prevention strategy?
“Theirs is a profession and an identity which is often linked with a sense of strength, leadership and [benevolent] power: adjectives, which on the surface one might see as incompatible with what instead, unfortunately, and wrongly, may be associated with mental health issues,” said Dr. Antonino.
Keep it private
When it comes to removing the stigma from mental health care and treatment for physicians, privacy is top of mind. There needs to be some form of privacy protection for physicians who seek professional help for mental health reasons. Dr. Lombardo said physicians need to have the choice to keep their mental health journeys private. “Ideally, normalization should mean openly conversing about mental health, but for physicians, it can be a matter of life or death for their career, so the choice to remain private is something that should be afforded to them.”
Along those lines, the American Medical Association is pushing for system changes in legislative and regulatory arenas to support the mental health of practicing physicians, residents, and medical students. The organization is also urging health systems and state medical licensing bodies to remove questions on their applications that ask about prior treatment for mental health conditions.
Among many programs across the country, the Foundation of the Pennsylvania Medical Society has also created a Physicians’ Health Program, which provides confidential assessment, counseling, and referral services for physicians with mental health concerns.
“All of these initiatives are important in helping to destigmatize mental health issues among physicians,” said Harold Hong, MD, a board-certified psychiatrist in Raleigh, N.C.
Hail the benefits of treatment
Dr. Hong said to continue to destigmatize mental health among physicians and normalize its treatment, we not only have to emphasize how attending to mental health has individual benefits but also how it helps us help our patients.
“One key aspect that perhaps underpins this issue is the still present separation between mental and physical health, between mind and body, Dr. Hong said in an interview. “Feeling sad or angry or anxious should become a fact of life, a characteristic of being human, just like catching a cold or breaking a leg.”
It’s a normalization that, perhaps more than anything else, can lead the way for improving physicians’ mental health outcomes while also improving them for the rest of society. When society can finally see the health and well-being of someone in both their psychological and physical status, some of the stigmas may dissipate, and perhaps more physicians’ lives can be saved.
A version of this article first appeared on Medscape.com.
Med students dismayed that residency match process won’t change
– mostly medical students, residents, and fellows – who supported the change.
The program’s decision comes after nearly 3 months of feedback from the public, medical students, and education community. Although about 60% of public respondents believed the change could reduce stress and allow students more time for momentous career decisions, the program’s board of directors decided the disadvantages were “of greater consequence,” according to a Oct. 28 statement.
Those disadvantages included introducing application or interview behaviors that could increase students’ stress; potentially identifying partially matched or unmatched applicants, which could lead to bias; and extending the match process time for those applicants.
In addition, members of 12 medical education and student organizations raised other concerns, such as the proposed change not addressing high application numbers, according to the statement. NRMP has reported record numbers of applicants over the past few years, typically with more applicants than available program slots.
“While the testimony gave nod to the positive aspects of the proposal ... there was substantially more concern voiced about the potential negative consequences identified in the public comments,” NRMP President and CEO Donna L. Lamb, DHSc, MBA, BSN, told this news organization. Some of those issues could not be addressed without further study, so the board decided not to proceed with the proposal, she explained.
The proposal would have separated the Main Residency Match into two phases and replaced the Supplemental Offer and Acceptance Program (SOAP), in which unmatched or partially matched applicants apply for unfilled residency positions. Under the proposed change, each phase would have operated the same way, from rank order lists and using a matching algorithm to a pair of Match Days instead of a single day.
The two-phase process would have given students who didn’t match more time to carefully weigh residency programs – they can apply to up to 45 placements as part of SOAP – that will guide their career path for the next few years, PGY-1 intern Asim A., who asked not to be identified further, told this news organization. The alternative is a hasty decision once students learn which residency spots are available, he added. “Applicants would have breathing room to make a more informed decision.”
Asim, who is Canadian, said he is participating in a transitional year in internal medicine in the hopes of being matched into internal medicine or psychiatry. He said Canada’s two-phase match is a “lot less stressful” than the U.S. system.
Meanwhile, students on Reddit’s medical school community also questioned NRMP’s decision.
“A significant majority of those surveyed thought it would be beneficial. But NRMP decides to not go through with it,” one Reddit user wrote. Another posted, “The one thing that could have improved the match and they chose not to do it.”
Others supported the decision to retain a 1-day match.
“I think this was the right call,” Bryan Carmody, MD, an outspoken medical education blogger, tweeted after learning of NRMP’s decision. Dr. Carmody, a pediatric nephrologist, previously expressed to this news organization misgivings about whether the two-phase match would make it difficult for programs to thoroughly review candidates and vice versa. He was concerned that it would compress the interview season and pressure programs to rapidly review applicants and conduct interviews.
More than 8,000 people responded to the public survey that began in August and ran for a month. Nearly two-thirds of the respondents (60%) were students, residents, or fellows. About 25% included faculty, program directors, and staff. Among the survey findings, respondents were equally divided between whether the two-phase match would be modestly advantageous (30%) or significantly advantageous (30%) compared to 20% who viewed it as modestly or significantly disadvantageous.
The NRMP said it would continue engaging with the community through focus groups and other means to improve the match experience and transition to residency.
“It is important to remember that a proposal is just that,” Dr. Lamb told this news orgnization, “an opportunity to discuss the pros and cons of an idea or framework ... and to mitigate unwanted consequences determined to be detrimental to learners and programs.”
The NRMP will involve the community in future discussions “to continue to give learners a voice,” she said.
A version of this article first appeared on Medscape.com.
– mostly medical students, residents, and fellows – who supported the change.
The program’s decision comes after nearly 3 months of feedback from the public, medical students, and education community. Although about 60% of public respondents believed the change could reduce stress and allow students more time for momentous career decisions, the program’s board of directors decided the disadvantages were “of greater consequence,” according to a Oct. 28 statement.
Those disadvantages included introducing application or interview behaviors that could increase students’ stress; potentially identifying partially matched or unmatched applicants, which could lead to bias; and extending the match process time for those applicants.
In addition, members of 12 medical education and student organizations raised other concerns, such as the proposed change not addressing high application numbers, according to the statement. NRMP has reported record numbers of applicants over the past few years, typically with more applicants than available program slots.
“While the testimony gave nod to the positive aspects of the proposal ... there was substantially more concern voiced about the potential negative consequences identified in the public comments,” NRMP President and CEO Donna L. Lamb, DHSc, MBA, BSN, told this news organization. Some of those issues could not be addressed without further study, so the board decided not to proceed with the proposal, she explained.
The proposal would have separated the Main Residency Match into two phases and replaced the Supplemental Offer and Acceptance Program (SOAP), in which unmatched or partially matched applicants apply for unfilled residency positions. Under the proposed change, each phase would have operated the same way, from rank order lists and using a matching algorithm to a pair of Match Days instead of a single day.
The two-phase process would have given students who didn’t match more time to carefully weigh residency programs – they can apply to up to 45 placements as part of SOAP – that will guide their career path for the next few years, PGY-1 intern Asim A., who asked not to be identified further, told this news organization. The alternative is a hasty decision once students learn which residency spots are available, he added. “Applicants would have breathing room to make a more informed decision.”
Asim, who is Canadian, said he is participating in a transitional year in internal medicine in the hopes of being matched into internal medicine or psychiatry. He said Canada’s two-phase match is a “lot less stressful” than the U.S. system.
Meanwhile, students on Reddit’s medical school community also questioned NRMP’s decision.
“A significant majority of those surveyed thought it would be beneficial. But NRMP decides to not go through with it,” one Reddit user wrote. Another posted, “The one thing that could have improved the match and they chose not to do it.”
Others supported the decision to retain a 1-day match.
“I think this was the right call,” Bryan Carmody, MD, an outspoken medical education blogger, tweeted after learning of NRMP’s decision. Dr. Carmody, a pediatric nephrologist, previously expressed to this news organization misgivings about whether the two-phase match would make it difficult for programs to thoroughly review candidates and vice versa. He was concerned that it would compress the interview season and pressure programs to rapidly review applicants and conduct interviews.
More than 8,000 people responded to the public survey that began in August and ran for a month. Nearly two-thirds of the respondents (60%) were students, residents, or fellows. About 25% included faculty, program directors, and staff. Among the survey findings, respondents were equally divided between whether the two-phase match would be modestly advantageous (30%) or significantly advantageous (30%) compared to 20% who viewed it as modestly or significantly disadvantageous.
The NRMP said it would continue engaging with the community through focus groups and other means to improve the match experience and transition to residency.
“It is important to remember that a proposal is just that,” Dr. Lamb told this news orgnization, “an opportunity to discuss the pros and cons of an idea or framework ... and to mitigate unwanted consequences determined to be detrimental to learners and programs.”
The NRMP will involve the community in future discussions “to continue to give learners a voice,” she said.
A version of this article first appeared on Medscape.com.
– mostly medical students, residents, and fellows – who supported the change.
The program’s decision comes after nearly 3 months of feedback from the public, medical students, and education community. Although about 60% of public respondents believed the change could reduce stress and allow students more time for momentous career decisions, the program’s board of directors decided the disadvantages were “of greater consequence,” according to a Oct. 28 statement.
Those disadvantages included introducing application or interview behaviors that could increase students’ stress; potentially identifying partially matched or unmatched applicants, which could lead to bias; and extending the match process time for those applicants.
In addition, members of 12 medical education and student organizations raised other concerns, such as the proposed change not addressing high application numbers, according to the statement. NRMP has reported record numbers of applicants over the past few years, typically with more applicants than available program slots.
“While the testimony gave nod to the positive aspects of the proposal ... there was substantially more concern voiced about the potential negative consequences identified in the public comments,” NRMP President and CEO Donna L. Lamb, DHSc, MBA, BSN, told this news organization. Some of those issues could not be addressed without further study, so the board decided not to proceed with the proposal, she explained.
The proposal would have separated the Main Residency Match into two phases and replaced the Supplemental Offer and Acceptance Program (SOAP), in which unmatched or partially matched applicants apply for unfilled residency positions. Under the proposed change, each phase would have operated the same way, from rank order lists and using a matching algorithm to a pair of Match Days instead of a single day.
The two-phase process would have given students who didn’t match more time to carefully weigh residency programs – they can apply to up to 45 placements as part of SOAP – that will guide their career path for the next few years, PGY-1 intern Asim A., who asked not to be identified further, told this news organization. The alternative is a hasty decision once students learn which residency spots are available, he added. “Applicants would have breathing room to make a more informed decision.”
Asim, who is Canadian, said he is participating in a transitional year in internal medicine in the hopes of being matched into internal medicine or psychiatry. He said Canada’s two-phase match is a “lot less stressful” than the U.S. system.
Meanwhile, students on Reddit’s medical school community also questioned NRMP’s decision.
“A significant majority of those surveyed thought it would be beneficial. But NRMP decides to not go through with it,” one Reddit user wrote. Another posted, “The one thing that could have improved the match and they chose not to do it.”
Others supported the decision to retain a 1-day match.
“I think this was the right call,” Bryan Carmody, MD, an outspoken medical education blogger, tweeted after learning of NRMP’s decision. Dr. Carmody, a pediatric nephrologist, previously expressed to this news organization misgivings about whether the two-phase match would make it difficult for programs to thoroughly review candidates and vice versa. He was concerned that it would compress the interview season and pressure programs to rapidly review applicants and conduct interviews.
More than 8,000 people responded to the public survey that began in August and ran for a month. Nearly two-thirds of the respondents (60%) were students, residents, or fellows. About 25% included faculty, program directors, and staff. Among the survey findings, respondents were equally divided between whether the two-phase match would be modestly advantageous (30%) or significantly advantageous (30%) compared to 20% who viewed it as modestly or significantly disadvantageous.
The NRMP said it would continue engaging with the community through focus groups and other means to improve the match experience and transition to residency.
“It is important to remember that a proposal is just that,” Dr. Lamb told this news orgnization, “an opportunity to discuss the pros and cons of an idea or framework ... and to mitigate unwanted consequences determined to be detrimental to learners and programs.”
The NRMP will involve the community in future discussions “to continue to give learners a voice,” she said.
A version of this article first appeared on Medscape.com.
If a saphenous graft is available, treat limb threatening ischemia surgically
CHICAGO – In patients with chronic limb-threatening ischemia (CLTI) and a usable saphenous vein segment, a surgical procedure leads to better outcomes than an endovascular approach, according results of the multinational randomized BEST-CLI trial.
In that study, conducted with two cohorts, the advantage of surgery was limited to the group with an available saphenous vein, but in this group the advantage over an endovascular approach was substantial, according to Alik Farber, MD, chief of vascular and endovascular surgery at Boston University.
“Bypass with adequate saphenous vein should be offered as a first-line treatment option for suitable candidates with CLTI as part of fully informed, shared decision-making,” Dr. Farber stated in presenting the results at the annual scientific sessions of the American Heart Association.
The study pursued two hypotheses, which is why CLTI patients were divided into two cohorts. For cohort 1, which was limited to CLTI patients with an available saphenous vein, it was predicted that surgery would be better than an endovascular approach. For cohort 2, which enrolled patients who needed an alternative conduit, the hypothesis was that endovascular procedures would prove superior.
The study confirmed the first hypothesis, but there was no difference between the two approaches for the composite primary outcome of major adverse limb events (MALE) in the second cohort.
Saphenous vein availability determined cohort
Candidates for the BEST-CLI (Best Endovascular versus Best Surgical Therapy in Patients with CLTI) trial had to have CLTI producing severe ischemia and to be judged by both surgeons and cardiovascular specialists to be candidates for both types of interventions. Eligible patients were then enrolled in cohort 1 if the saphenous vein was considered the best conduit on imaging. If not, they were enrolled in cohort 2.
Patients were randomized to undergo surgical or endovascular repair only after the cohort was assigned. The primary composite MALE endpoint consisted of an adjudicated first major reintervention, such as new bypass or thrombectomy, an above-the-ankle amputation, or death from any cause.
In cohort 1, the primary composite MALE endpoint was reached in 42.6% of those in surgical arm and 57.4% in the endovascular arm, translating into a 32% relative risk reduction (hazard ratio, 0.68; P < .001) in favor of surgery at the end of a median of 2.7 years of follow-up.
The main advantage was the difference in reinterventions. The lower rate in the surgical group (9.2% vs. 23.5%), translated into a 65% relative risk reduction for this endpoint (HR, 035; P < .001).
The reduction in above-ankle amputations in the surgical group (10.4% vs. 14.9%) was also significant (HR, 0.73; P = .04), but the reduction in all-cause mortality (33.0% vs. 37.6%) was not (HR, 0.98; P = .81).
BEST-CLI involved 150 sites in North America, Europe, and New Zealand. Cohort 1, which randomized 1,434 patients, was the larger of the two. In the second cohort, only 396 patients were randomized, which Dr. Farber said “might have been underpowered.”
The results were published in the New England Journal of Medicine simultaneously with presentation of the results at the meeting.
After a median follow-up of 1.6 years in cohort 2, the slightly lower proportion of patients who reached the composite MALE endpoint in the surgical group relative to the endovascular group (42.8% vs. 47.7%) did not translate into a significant advantage (HR, 0.79; P = .12).
For the individual components, the lower rate of reinterventions in the surgical arm (14.4% vs. 25.6%) did reach statistical significance (HR, 0.47; P = .002), but both amputation (14.9% vs. 14.1%) and all-cause death (26.3% vs. 24.1%) were numerically but not significantly higher in the surgical group.
The primary safety endpoint was major adverse cardiovascular events (MACE). This was not significantly different in either cohort. There were also no major differences between groups in the risk of perioperative complications.
Level 1 evidence provided for intervention choice
Overall, BEST-CLI showed that both surgical and endovascular revascularizations are effective and safe, according to Dr. Farber. As a result, he suggested that both can be considered even if a saphenous vein is available when specific patient characteristics make one more attractive than another.
Yet, in a general population with an available saphenous vein, these data provide “level 1 evidence” that a surgical approach should be the dominant choice, he added.
A quality of life (QOL) substudy of BEST-CLI did not challenge this conclusion. Rather, the main finding was that restoring circulation by either approach has a major favorable impact on patient well-being, according to Matthew Menard, MD, codirector of endovascular surgery at Brigham and Women’s Hospital, Boston.
In this substudy, presented separately from the primary BEST-CLI results, that analysis confirmed that baseline QOL was extremely poor, whether measured with a disease specific instrument such as VascuQol, or generic instruments, such as SF-12.
Surgical or endovascular treatment produced clinically meaningful and sustained improvements in every QOL measure employed, according to Dr. Menard, and this was true in either cohort.
Results not necessarily relevant to all
These data are likely relevant to the patients evaluated, but “it is important to consider who made it into this trial,” according to Naomi M. Hamburg, MD, section chief of vascular biology at Boston University.
Not least, patients had to be candidates for either surgical or endovascular repair to get into the study, omitting those patients not deemed by the investigators to be suited for either.
In addition, Dr. Hamburg pointed out that there was a low enrollment of Blacks (20%) and women (28%), two groups for whom CTLI is a common condition.
Lastly, Dr Hamburg questioned whether specific types of anatomy might be better suited to one procedure relative to another, a variable not considered in this study. Reassured by Dr. Farber that this will be explored in subsequent analyses of BEST-CLI data, Dr. Hamburg expressed interest in learning the results.
Dr. Hamburg was among those who spoke about the growing urgency to optimize strategies for early diagnosis and treatment of CTLI. She plugged the PAD National Action Plan as one of the efforts to thwart the coming wave of CTLI expected from the steep climb in the prevalence of diabetes in the United States.
Dr. Farber reported a financial relationship with Sanifit Therapeutics. The study was funded by the National Heart, Lung, and Blood Institute, but received additional support from multiple pharmaceutical companies. Dr. Menard reported a financial relationship with Janssen Pharmaceuticals. Dr. Hamburg reported financial relationships with Acceleron Pharma, Merck, NovoNordisk, and Sanifit.
CHICAGO – In patients with chronic limb-threatening ischemia (CLTI) and a usable saphenous vein segment, a surgical procedure leads to better outcomes than an endovascular approach, according results of the multinational randomized BEST-CLI trial.
In that study, conducted with two cohorts, the advantage of surgery was limited to the group with an available saphenous vein, but in this group the advantage over an endovascular approach was substantial, according to Alik Farber, MD, chief of vascular and endovascular surgery at Boston University.
“Bypass with adequate saphenous vein should be offered as a first-line treatment option for suitable candidates with CLTI as part of fully informed, shared decision-making,” Dr. Farber stated in presenting the results at the annual scientific sessions of the American Heart Association.
The study pursued two hypotheses, which is why CLTI patients were divided into two cohorts. For cohort 1, which was limited to CLTI patients with an available saphenous vein, it was predicted that surgery would be better than an endovascular approach. For cohort 2, which enrolled patients who needed an alternative conduit, the hypothesis was that endovascular procedures would prove superior.
The study confirmed the first hypothesis, but there was no difference between the two approaches for the composite primary outcome of major adverse limb events (MALE) in the second cohort.
Saphenous vein availability determined cohort
Candidates for the BEST-CLI (Best Endovascular versus Best Surgical Therapy in Patients with CLTI) trial had to have CLTI producing severe ischemia and to be judged by both surgeons and cardiovascular specialists to be candidates for both types of interventions. Eligible patients were then enrolled in cohort 1 if the saphenous vein was considered the best conduit on imaging. If not, they were enrolled in cohort 2.
Patients were randomized to undergo surgical or endovascular repair only after the cohort was assigned. The primary composite MALE endpoint consisted of an adjudicated first major reintervention, such as new bypass or thrombectomy, an above-the-ankle amputation, or death from any cause.
In cohort 1, the primary composite MALE endpoint was reached in 42.6% of those in surgical arm and 57.4% in the endovascular arm, translating into a 32% relative risk reduction (hazard ratio, 0.68; P < .001) in favor of surgery at the end of a median of 2.7 years of follow-up.
The main advantage was the difference in reinterventions. The lower rate in the surgical group (9.2% vs. 23.5%), translated into a 65% relative risk reduction for this endpoint (HR, 035; P < .001).
The reduction in above-ankle amputations in the surgical group (10.4% vs. 14.9%) was also significant (HR, 0.73; P = .04), but the reduction in all-cause mortality (33.0% vs. 37.6%) was not (HR, 0.98; P = .81).
BEST-CLI involved 150 sites in North America, Europe, and New Zealand. Cohort 1, which randomized 1,434 patients, was the larger of the two. In the second cohort, only 396 patients were randomized, which Dr. Farber said “might have been underpowered.”
The results were published in the New England Journal of Medicine simultaneously with presentation of the results at the meeting.
After a median follow-up of 1.6 years in cohort 2, the slightly lower proportion of patients who reached the composite MALE endpoint in the surgical group relative to the endovascular group (42.8% vs. 47.7%) did not translate into a significant advantage (HR, 0.79; P = .12).
For the individual components, the lower rate of reinterventions in the surgical arm (14.4% vs. 25.6%) did reach statistical significance (HR, 0.47; P = .002), but both amputation (14.9% vs. 14.1%) and all-cause death (26.3% vs. 24.1%) were numerically but not significantly higher in the surgical group.
The primary safety endpoint was major adverse cardiovascular events (MACE). This was not significantly different in either cohort. There were also no major differences between groups in the risk of perioperative complications.
Level 1 evidence provided for intervention choice
Overall, BEST-CLI showed that both surgical and endovascular revascularizations are effective and safe, according to Dr. Farber. As a result, he suggested that both can be considered even if a saphenous vein is available when specific patient characteristics make one more attractive than another.
Yet, in a general population with an available saphenous vein, these data provide “level 1 evidence” that a surgical approach should be the dominant choice, he added.
A quality of life (QOL) substudy of BEST-CLI did not challenge this conclusion. Rather, the main finding was that restoring circulation by either approach has a major favorable impact on patient well-being, according to Matthew Menard, MD, codirector of endovascular surgery at Brigham and Women’s Hospital, Boston.
In this substudy, presented separately from the primary BEST-CLI results, that analysis confirmed that baseline QOL was extremely poor, whether measured with a disease specific instrument such as VascuQol, or generic instruments, such as SF-12.
Surgical or endovascular treatment produced clinically meaningful and sustained improvements in every QOL measure employed, according to Dr. Menard, and this was true in either cohort.
Results not necessarily relevant to all
These data are likely relevant to the patients evaluated, but “it is important to consider who made it into this trial,” according to Naomi M. Hamburg, MD, section chief of vascular biology at Boston University.
Not least, patients had to be candidates for either surgical or endovascular repair to get into the study, omitting those patients not deemed by the investigators to be suited for either.
In addition, Dr. Hamburg pointed out that there was a low enrollment of Blacks (20%) and women (28%), two groups for whom CTLI is a common condition.
Lastly, Dr Hamburg questioned whether specific types of anatomy might be better suited to one procedure relative to another, a variable not considered in this study. Reassured by Dr. Farber that this will be explored in subsequent analyses of BEST-CLI data, Dr. Hamburg expressed interest in learning the results.
Dr. Hamburg was among those who spoke about the growing urgency to optimize strategies for early diagnosis and treatment of CTLI. She plugged the PAD National Action Plan as one of the efforts to thwart the coming wave of CTLI expected from the steep climb in the prevalence of diabetes in the United States.
Dr. Farber reported a financial relationship with Sanifit Therapeutics. The study was funded by the National Heart, Lung, and Blood Institute, but received additional support from multiple pharmaceutical companies. Dr. Menard reported a financial relationship with Janssen Pharmaceuticals. Dr. Hamburg reported financial relationships with Acceleron Pharma, Merck, NovoNordisk, and Sanifit.
CHICAGO – In patients with chronic limb-threatening ischemia (CLTI) and a usable saphenous vein segment, a surgical procedure leads to better outcomes than an endovascular approach, according results of the multinational randomized BEST-CLI trial.
In that study, conducted with two cohorts, the advantage of surgery was limited to the group with an available saphenous vein, but in this group the advantage over an endovascular approach was substantial, according to Alik Farber, MD, chief of vascular and endovascular surgery at Boston University.
“Bypass with adequate saphenous vein should be offered as a first-line treatment option for suitable candidates with CLTI as part of fully informed, shared decision-making,” Dr. Farber stated in presenting the results at the annual scientific sessions of the American Heart Association.
The study pursued two hypotheses, which is why CLTI patients were divided into two cohorts. For cohort 1, which was limited to CLTI patients with an available saphenous vein, it was predicted that surgery would be better than an endovascular approach. For cohort 2, which enrolled patients who needed an alternative conduit, the hypothesis was that endovascular procedures would prove superior.
The study confirmed the first hypothesis, but there was no difference between the two approaches for the composite primary outcome of major adverse limb events (MALE) in the second cohort.
Saphenous vein availability determined cohort
Candidates for the BEST-CLI (Best Endovascular versus Best Surgical Therapy in Patients with CLTI) trial had to have CLTI producing severe ischemia and to be judged by both surgeons and cardiovascular specialists to be candidates for both types of interventions. Eligible patients were then enrolled in cohort 1 if the saphenous vein was considered the best conduit on imaging. If not, they were enrolled in cohort 2.
Patients were randomized to undergo surgical or endovascular repair only after the cohort was assigned. The primary composite MALE endpoint consisted of an adjudicated first major reintervention, such as new bypass or thrombectomy, an above-the-ankle amputation, or death from any cause.
In cohort 1, the primary composite MALE endpoint was reached in 42.6% of those in surgical arm and 57.4% in the endovascular arm, translating into a 32% relative risk reduction (hazard ratio, 0.68; P < .001) in favor of surgery at the end of a median of 2.7 years of follow-up.
The main advantage was the difference in reinterventions. The lower rate in the surgical group (9.2% vs. 23.5%), translated into a 65% relative risk reduction for this endpoint (HR, 035; P < .001).
The reduction in above-ankle amputations in the surgical group (10.4% vs. 14.9%) was also significant (HR, 0.73; P = .04), but the reduction in all-cause mortality (33.0% vs. 37.6%) was not (HR, 0.98; P = .81).
BEST-CLI involved 150 sites in North America, Europe, and New Zealand. Cohort 1, which randomized 1,434 patients, was the larger of the two. In the second cohort, only 396 patients were randomized, which Dr. Farber said “might have been underpowered.”
The results were published in the New England Journal of Medicine simultaneously with presentation of the results at the meeting.
After a median follow-up of 1.6 years in cohort 2, the slightly lower proportion of patients who reached the composite MALE endpoint in the surgical group relative to the endovascular group (42.8% vs. 47.7%) did not translate into a significant advantage (HR, 0.79; P = .12).
For the individual components, the lower rate of reinterventions in the surgical arm (14.4% vs. 25.6%) did reach statistical significance (HR, 0.47; P = .002), but both amputation (14.9% vs. 14.1%) and all-cause death (26.3% vs. 24.1%) were numerically but not significantly higher in the surgical group.
The primary safety endpoint was major adverse cardiovascular events (MACE). This was not significantly different in either cohort. There were also no major differences between groups in the risk of perioperative complications.
Level 1 evidence provided for intervention choice
Overall, BEST-CLI showed that both surgical and endovascular revascularizations are effective and safe, according to Dr. Farber. As a result, he suggested that both can be considered even if a saphenous vein is available when specific patient characteristics make one more attractive than another.
Yet, in a general population with an available saphenous vein, these data provide “level 1 evidence” that a surgical approach should be the dominant choice, he added.
A quality of life (QOL) substudy of BEST-CLI did not challenge this conclusion. Rather, the main finding was that restoring circulation by either approach has a major favorable impact on patient well-being, according to Matthew Menard, MD, codirector of endovascular surgery at Brigham and Women’s Hospital, Boston.
In this substudy, presented separately from the primary BEST-CLI results, that analysis confirmed that baseline QOL was extremely poor, whether measured with a disease specific instrument such as VascuQol, or generic instruments, such as SF-12.
Surgical or endovascular treatment produced clinically meaningful and sustained improvements in every QOL measure employed, according to Dr. Menard, and this was true in either cohort.
Results not necessarily relevant to all
These data are likely relevant to the patients evaluated, but “it is important to consider who made it into this trial,” according to Naomi M. Hamburg, MD, section chief of vascular biology at Boston University.
Not least, patients had to be candidates for either surgical or endovascular repair to get into the study, omitting those patients not deemed by the investigators to be suited for either.
In addition, Dr. Hamburg pointed out that there was a low enrollment of Blacks (20%) and women (28%), two groups for whom CTLI is a common condition.
Lastly, Dr Hamburg questioned whether specific types of anatomy might be better suited to one procedure relative to another, a variable not considered in this study. Reassured by Dr. Farber that this will be explored in subsequent analyses of BEST-CLI data, Dr. Hamburg expressed interest in learning the results.
Dr. Hamburg was among those who spoke about the growing urgency to optimize strategies for early diagnosis and treatment of CTLI. She plugged the PAD National Action Plan as one of the efforts to thwart the coming wave of CTLI expected from the steep climb in the prevalence of diabetes in the United States.
Dr. Farber reported a financial relationship with Sanifit Therapeutics. The study was funded by the National Heart, Lung, and Blood Institute, but received additional support from multiple pharmaceutical companies. Dr. Menard reported a financial relationship with Janssen Pharmaceuticals. Dr. Hamburg reported financial relationships with Acceleron Pharma, Merck, NovoNordisk, and Sanifit.
AT AHA 2022
Children and COVID: New cases increase for second straight week
New COVID-19 cases rose among U.S. children for the second consecutive week, while hospitals saw signs of renewed activity on the part of SARS-CoV-2.
, when the count fell to its lowest level in more than a year, the American Academy of Pediatrics and the Children’s Hospital Association said in their joint report.
The 7-day average for ED visits with diagnosed COVID was down to just 0.6% of all ED visits for 12- to 15-year-olds as late as Oct. 23 but has moved up to 0.7% since then. Among those aged 16-17 years, the 7-day average was also down to 0.6% for just one day, Oct. 19, but was up to 0.8% as of Nov. 4. So far, though, a similar increase has not yet occurred for ED visits among children aged 0-11 years, the CDC said on its COVID Data Tracker.
The trend is discernible, however, when looking at hospitalizations of children with confirmed COVID. The rate of new admissions of children aged 0-17 years was 0.16 per 100,000 population as late as Oct. 23 but ticked up a notch after that and has been 0.17 per 100,000 since, according to the CDC. As with the ED rate, hospitalizations had been steadily declining since late August.
Vaccine initiation continues to slow
During the week of Oct. 27 to Nov. 2, about 30,000 children under 5 years of age received their initial COVID vaccination. A month earlier (Sept. 29 to Oct. 5), that number was about 40,000. A month before that, about 53,000 children aged 0-5 years received their initial dose, the AAP said in a separate vaccination report based on CDC data.
All of that reduced interest adds up to 7.4% of the age group having received at least one dose and just 3.2% being fully vaccinated as of Nov. 2. Among children aged 5-11 years, the corresponding vaccination rates are 38.9% and 31.8%, while those aged 12-17 years are at 71.3% and 61.1%, the CDC said.
Looking at just the first 20 weeks of the vaccination experience for each age group shows that 1.6 million children under 5 years of age had received at least an initial dose, compared with 8.1 million children aged 5-11 years and 8.1 million children aged 12-15, the AAP said.
New COVID-19 cases rose among U.S. children for the second consecutive week, while hospitals saw signs of renewed activity on the part of SARS-CoV-2.
, when the count fell to its lowest level in more than a year, the American Academy of Pediatrics and the Children’s Hospital Association said in their joint report.
The 7-day average for ED visits with diagnosed COVID was down to just 0.6% of all ED visits for 12- to 15-year-olds as late as Oct. 23 but has moved up to 0.7% since then. Among those aged 16-17 years, the 7-day average was also down to 0.6% for just one day, Oct. 19, but was up to 0.8% as of Nov. 4. So far, though, a similar increase has not yet occurred for ED visits among children aged 0-11 years, the CDC said on its COVID Data Tracker.
The trend is discernible, however, when looking at hospitalizations of children with confirmed COVID. The rate of new admissions of children aged 0-17 years was 0.16 per 100,000 population as late as Oct. 23 but ticked up a notch after that and has been 0.17 per 100,000 since, according to the CDC. As with the ED rate, hospitalizations had been steadily declining since late August.
Vaccine initiation continues to slow
During the week of Oct. 27 to Nov. 2, about 30,000 children under 5 years of age received their initial COVID vaccination. A month earlier (Sept. 29 to Oct. 5), that number was about 40,000. A month before that, about 53,000 children aged 0-5 years received their initial dose, the AAP said in a separate vaccination report based on CDC data.
All of that reduced interest adds up to 7.4% of the age group having received at least one dose and just 3.2% being fully vaccinated as of Nov. 2. Among children aged 5-11 years, the corresponding vaccination rates are 38.9% and 31.8%, while those aged 12-17 years are at 71.3% and 61.1%, the CDC said.
Looking at just the first 20 weeks of the vaccination experience for each age group shows that 1.6 million children under 5 years of age had received at least an initial dose, compared with 8.1 million children aged 5-11 years and 8.1 million children aged 12-15, the AAP said.
New COVID-19 cases rose among U.S. children for the second consecutive week, while hospitals saw signs of renewed activity on the part of SARS-CoV-2.
, when the count fell to its lowest level in more than a year, the American Academy of Pediatrics and the Children’s Hospital Association said in their joint report.
The 7-day average for ED visits with diagnosed COVID was down to just 0.6% of all ED visits for 12- to 15-year-olds as late as Oct. 23 but has moved up to 0.7% since then. Among those aged 16-17 years, the 7-day average was also down to 0.6% for just one day, Oct. 19, but was up to 0.8% as of Nov. 4. So far, though, a similar increase has not yet occurred for ED visits among children aged 0-11 years, the CDC said on its COVID Data Tracker.
The trend is discernible, however, when looking at hospitalizations of children with confirmed COVID. The rate of new admissions of children aged 0-17 years was 0.16 per 100,000 population as late as Oct. 23 but ticked up a notch after that and has been 0.17 per 100,000 since, according to the CDC. As with the ED rate, hospitalizations had been steadily declining since late August.
Vaccine initiation continues to slow
During the week of Oct. 27 to Nov. 2, about 30,000 children under 5 years of age received their initial COVID vaccination. A month earlier (Sept. 29 to Oct. 5), that number was about 40,000. A month before that, about 53,000 children aged 0-5 years received their initial dose, the AAP said in a separate vaccination report based on CDC data.
All of that reduced interest adds up to 7.4% of the age group having received at least one dose and just 3.2% being fully vaccinated as of Nov. 2. Among children aged 5-11 years, the corresponding vaccination rates are 38.9% and 31.8%, while those aged 12-17 years are at 71.3% and 61.1%, the CDC said.
Looking at just the first 20 weeks of the vaccination experience for each age group shows that 1.6 million children under 5 years of age had received at least an initial dose, compared with 8.1 million children aged 5-11 years and 8.1 million children aged 12-15, the AAP said.
EHR-based thromboembolism risk tool boosted prophylaxis
CHICAGO – A clinical decision-support tool designed to identify hospitalized patients who need thromboembolism prophylaxis and embedded in a hospital’s electronic health record led to significantly more appropriate prophylaxis, compared with usual care, and significantly cut the 30-day rate of thromboembolism in a randomized, multicenter trial with more than 10,000 patients.
“This is the first time that a clinical decision support tool not only changed [thromboprophylaxis prescribing] behavior but also affected hard outcomes. That’s remarkable,” lead investigator Alex C. Spyropoulos, MD, said in an interview.
Even so, outside experts expressed concerns about certain results and the trial design.
Use of the decision-support risk calculator for thromboembolism in the IMPROVE-DD VTE trial significantly boosted use of appropriate inpatient thromboprophylaxis starting at hospital admission by a relative 52%, and significantly increased outpatient thromboprophylaxis prescribed at discharge by a relative 93% in the study’s two primary endpoints, Dr. Spyropoulos reported at the American Heart Association scientific sessions.
This intervention led to a significant 29% relative reduction in the incidence of total thromboembolic events, both venous and arterial, during hospitalization and through 30 days post discharge.
The absolute thromboembolic event rates were 2.9% among 5,249 patients treated at either of two U.S. hospitals that used the EHR-based risk calculator and 4.0% in 5,450 patients seen at either of two other U.S. hospitals that served as controls and where usual care method identified patients who needed thromboprophylaxis, said Dr. Spyropoulos, professor and director of the anticoagulation and clinical thrombosis services for Northwell Health in New York. This included a 2.7% rate of venous thromboembolism and a 0.25% rate of arterial thromboembolism in the intervention patients, and a 3.3% rate of venous events and a 0.7% rate of arterial events in the controls.
Patients treated at the hospitals that used the EHR-embedded risk calculator also has a numerically lower rate of major bleeding events during hospitalization and 30-day postdischarge follow-up, a 0.15% rate compared with a 0.22% rate in the control patients, a difference that was not significant.
A ‘powerful message’
“It’s a powerful message to see an absolute 1.1% difference in the rate of thromboembolism and a trend to fewer major bleeds. I think this will change practice,” Dr. Spyropoulos added in the interview. “The next step is dissemination.”
But thromboprophylaxis experts cautioned that, while the results looked promising, the findings need more analysis and review, and the intervention may need further testing before it’s ready for widespread use.
For example, one unexpected result was an unexpected 2.1 percentage point increase in all-cause mortality linked with use of the decision-support tool. Total deaths from admission to 30 days after discharge occurred in 9.1% of the patients treated at the two hospitals that used the risk calculator and 7.0% among the control patients, a difference that Dr, Spyropoulos said was likely the result of unbalanced outcomes from COVID-19 infections that had no relevance to the tested intervention. The trial ran during December 2020–January 2022.
But wait – more detail and analysis needed
“I’d like to see more analysis of the data from this trial,” and “there is the issue of increased mortality,” commented Gregory Piazza, MD, director of vascular medicine at Brigham and Women’s Hospital in Boston, and a specialist in thromboembolism prevention and management. He also highlighted the need for greater detail on the arterial thromboembolic events tallied during the study.
With more details and analysis of these findings “we’ll learn more about the true impact” of this intervention, Dr. Piazza said in an interview.
“The increased mortality in the intervention group may have been due to differential treatment and decision-making and confounding and warrants further investigation,” commented Elaine M. Hylek, MD, a professor at Boston University and designated discussant for the report. Selection bias may have contributed to this possible confounding, Dr. Hylek noted.
Other limitations of the study cited by Dr. Hylek included its reliance on individual clinician decision-making to actually prescribe thromboprophylaxis, a lack of information on patient adherence to their thromboprophylaxis prescription, and an overall low rate of appropriate thromboprophylaxis prescribed to patients at discharge. The rates were 7.5% among the controls and 13.6% among patients in the intervention arm. For prescription at the time of hospitalization, the rates were 72.5% among control patients and 80.1% for patients seen at the two hospitals that used the decision-support tool.
The IMPROVE-DD VTE risk assessment tool
The clinical decision-support tool tested is called the IMPROVE-DD VTE risk assessment model, developed over several years by Dr. Spyropoulos and associates; they have also performed multiple validation studies. The model includes eight factors that score 1-3 points if positive that can add up to total scores of 0-14. A score of 0 or 1 is considered low risk, 2 or 3 intermediate risk, and 4 or more high risk. One of the scoring factors is the result of a D-dimer test, which explains the DD part of the name.
The eight factors and point assignments are prior venous thromboembolism: 3 points; known thrombophilia: 2 points; lower limb paralysis: 2 points; current cancer: 2 points; d-dimer level more than twofold the upper limit of normal: 2 points; immobilized for at least 7 days: 1 point; admitted to the ICU or coronary care unit: 1 point; and age greater than 60 years old: 1 point.
Development of the IMPROVE-DD VTE risk calculator received most of its funding from the U.S. Agency for Healthcare Research and Quality, and the risk tool will be available for hospitals and health systems to access at no charge through the agency’s website, Dr. Spyropoulos said. The researchers designed the calculator to operate in any EHR product.
IMPROVE-DD VTE “is a very valid, high-quality tool,” commented Dr. Piazza. “We’ve used some rather blunt tools in the past,” and especially praised inclusion of D-dimer results into the IMPROVE-DD VTE model.
“It’s nice to use a biomarker in addition to clinical factors,” he said. “A biomarker provides a more holistic picture; we can’t do genetic testing on every patient.”
Enrollment focused on higher-risk patients
The study ran at four academic, tertiary-care hospitals in the Northwell Health network in the New York region. It enrolled patients aged more than 60 years who were hospitalized for any of five diagnoses: heart failure; acute respiratory insufficiency, including chronic obstructive lung disease or asthma; acute infectious disease, including COVID-19; acute inflammatory disease, including rheumatic disease; or acute stroke. The study excluded patients with a history of atrial fibrillation, those who used an anticoagulant at home, or those who had received therapeutic anticoagulation within 24 hours of their hospital admission.
The anticoagulant prophylaxis that patients received depended on their calculated risk level – intermediate or high – and whether they were inpatients or being discharged. The anticoagulants that clinicians could prescribe included unfractionated heparin, enoxaparin, fondaparinux, rivaroxaban, and apixaban.
“We’ve been looking for a long time for a tool for medically ill patients that’s like the CHA2DS2-VASc score” for patients with atrial fibrillation. “These powerful data say we now have this, and the EHR provides a vehicle to easily implement it,” Dr. Spyropoulos said.
The IMPROVE-DD VTE study received partial funding from Janssen. Dr. Spyropoulos has been a consultant to Nayer, Boehringer Ingelheim, Bristol-Myers Squibb, Janssen, Pfizer, and Sanofi; adviser to the ATLAS Group; and has received research support from Janssen. Dr. Piazza has received research funding from Bayer, BIG/EKOS, BMS, Janssen, and Portola. Dr. Hylek had been a consultant to Bayer and Ionis, and has received honoraria from Boehringer Ingelheim and Pfizer.
CHICAGO – A clinical decision-support tool designed to identify hospitalized patients who need thromboembolism prophylaxis and embedded in a hospital’s electronic health record led to significantly more appropriate prophylaxis, compared with usual care, and significantly cut the 30-day rate of thromboembolism in a randomized, multicenter trial with more than 10,000 patients.
“This is the first time that a clinical decision support tool not only changed [thromboprophylaxis prescribing] behavior but also affected hard outcomes. That’s remarkable,” lead investigator Alex C. Spyropoulos, MD, said in an interview.
Even so, outside experts expressed concerns about certain results and the trial design.
Use of the decision-support risk calculator for thromboembolism in the IMPROVE-DD VTE trial significantly boosted use of appropriate inpatient thromboprophylaxis starting at hospital admission by a relative 52%, and significantly increased outpatient thromboprophylaxis prescribed at discharge by a relative 93% in the study’s two primary endpoints, Dr. Spyropoulos reported at the American Heart Association scientific sessions.
This intervention led to a significant 29% relative reduction in the incidence of total thromboembolic events, both venous and arterial, during hospitalization and through 30 days post discharge.
The absolute thromboembolic event rates were 2.9% among 5,249 patients treated at either of two U.S. hospitals that used the EHR-based risk calculator and 4.0% in 5,450 patients seen at either of two other U.S. hospitals that served as controls and where usual care method identified patients who needed thromboprophylaxis, said Dr. Spyropoulos, professor and director of the anticoagulation and clinical thrombosis services for Northwell Health in New York. This included a 2.7% rate of venous thromboembolism and a 0.25% rate of arterial thromboembolism in the intervention patients, and a 3.3% rate of venous events and a 0.7% rate of arterial events in the controls.
Patients treated at the hospitals that used the EHR-embedded risk calculator also has a numerically lower rate of major bleeding events during hospitalization and 30-day postdischarge follow-up, a 0.15% rate compared with a 0.22% rate in the control patients, a difference that was not significant.
A ‘powerful message’
“It’s a powerful message to see an absolute 1.1% difference in the rate of thromboembolism and a trend to fewer major bleeds. I think this will change practice,” Dr. Spyropoulos added in the interview. “The next step is dissemination.”
But thromboprophylaxis experts cautioned that, while the results looked promising, the findings need more analysis and review, and the intervention may need further testing before it’s ready for widespread use.
For example, one unexpected result was an unexpected 2.1 percentage point increase in all-cause mortality linked with use of the decision-support tool. Total deaths from admission to 30 days after discharge occurred in 9.1% of the patients treated at the two hospitals that used the risk calculator and 7.0% among the control patients, a difference that Dr, Spyropoulos said was likely the result of unbalanced outcomes from COVID-19 infections that had no relevance to the tested intervention. The trial ran during December 2020–January 2022.
But wait – more detail and analysis needed
“I’d like to see more analysis of the data from this trial,” and “there is the issue of increased mortality,” commented Gregory Piazza, MD, director of vascular medicine at Brigham and Women’s Hospital in Boston, and a specialist in thromboembolism prevention and management. He also highlighted the need for greater detail on the arterial thromboembolic events tallied during the study.
With more details and analysis of these findings “we’ll learn more about the true impact” of this intervention, Dr. Piazza said in an interview.
“The increased mortality in the intervention group may have been due to differential treatment and decision-making and confounding and warrants further investigation,” commented Elaine M. Hylek, MD, a professor at Boston University and designated discussant for the report. Selection bias may have contributed to this possible confounding, Dr. Hylek noted.
Other limitations of the study cited by Dr. Hylek included its reliance on individual clinician decision-making to actually prescribe thromboprophylaxis, a lack of information on patient adherence to their thromboprophylaxis prescription, and an overall low rate of appropriate thromboprophylaxis prescribed to patients at discharge. The rates were 7.5% among the controls and 13.6% among patients in the intervention arm. For prescription at the time of hospitalization, the rates were 72.5% among control patients and 80.1% for patients seen at the two hospitals that used the decision-support tool.
The IMPROVE-DD VTE risk assessment tool
The clinical decision-support tool tested is called the IMPROVE-DD VTE risk assessment model, developed over several years by Dr. Spyropoulos and associates; they have also performed multiple validation studies. The model includes eight factors that score 1-3 points if positive that can add up to total scores of 0-14. A score of 0 or 1 is considered low risk, 2 or 3 intermediate risk, and 4 or more high risk. One of the scoring factors is the result of a D-dimer test, which explains the DD part of the name.
The eight factors and point assignments are prior venous thromboembolism: 3 points; known thrombophilia: 2 points; lower limb paralysis: 2 points; current cancer: 2 points; d-dimer level more than twofold the upper limit of normal: 2 points; immobilized for at least 7 days: 1 point; admitted to the ICU or coronary care unit: 1 point; and age greater than 60 years old: 1 point.
Development of the IMPROVE-DD VTE risk calculator received most of its funding from the U.S. Agency for Healthcare Research and Quality, and the risk tool will be available for hospitals and health systems to access at no charge through the agency’s website, Dr. Spyropoulos said. The researchers designed the calculator to operate in any EHR product.
IMPROVE-DD VTE “is a very valid, high-quality tool,” commented Dr. Piazza. “We’ve used some rather blunt tools in the past,” and especially praised inclusion of D-dimer results into the IMPROVE-DD VTE model.
“It’s nice to use a biomarker in addition to clinical factors,” he said. “A biomarker provides a more holistic picture; we can’t do genetic testing on every patient.”
Enrollment focused on higher-risk patients
The study ran at four academic, tertiary-care hospitals in the Northwell Health network in the New York region. It enrolled patients aged more than 60 years who were hospitalized for any of five diagnoses: heart failure; acute respiratory insufficiency, including chronic obstructive lung disease or asthma; acute infectious disease, including COVID-19; acute inflammatory disease, including rheumatic disease; or acute stroke. The study excluded patients with a history of atrial fibrillation, those who used an anticoagulant at home, or those who had received therapeutic anticoagulation within 24 hours of their hospital admission.
The anticoagulant prophylaxis that patients received depended on their calculated risk level – intermediate or high – and whether they were inpatients or being discharged. The anticoagulants that clinicians could prescribe included unfractionated heparin, enoxaparin, fondaparinux, rivaroxaban, and apixaban.
“We’ve been looking for a long time for a tool for medically ill patients that’s like the CHA2DS2-VASc score” for patients with atrial fibrillation. “These powerful data say we now have this, and the EHR provides a vehicle to easily implement it,” Dr. Spyropoulos said.
The IMPROVE-DD VTE study received partial funding from Janssen. Dr. Spyropoulos has been a consultant to Nayer, Boehringer Ingelheim, Bristol-Myers Squibb, Janssen, Pfizer, and Sanofi; adviser to the ATLAS Group; and has received research support from Janssen. Dr. Piazza has received research funding from Bayer, BIG/EKOS, BMS, Janssen, and Portola. Dr. Hylek had been a consultant to Bayer and Ionis, and has received honoraria from Boehringer Ingelheim and Pfizer.
CHICAGO – A clinical decision-support tool designed to identify hospitalized patients who need thromboembolism prophylaxis and embedded in a hospital’s electronic health record led to significantly more appropriate prophylaxis, compared with usual care, and significantly cut the 30-day rate of thromboembolism in a randomized, multicenter trial with more than 10,000 patients.
“This is the first time that a clinical decision support tool not only changed [thromboprophylaxis prescribing] behavior but also affected hard outcomes. That’s remarkable,” lead investigator Alex C. Spyropoulos, MD, said in an interview.
Even so, outside experts expressed concerns about certain results and the trial design.
Use of the decision-support risk calculator for thromboembolism in the IMPROVE-DD VTE trial significantly boosted use of appropriate inpatient thromboprophylaxis starting at hospital admission by a relative 52%, and significantly increased outpatient thromboprophylaxis prescribed at discharge by a relative 93% in the study’s two primary endpoints, Dr. Spyropoulos reported at the American Heart Association scientific sessions.
This intervention led to a significant 29% relative reduction in the incidence of total thromboembolic events, both venous and arterial, during hospitalization and through 30 days post discharge.
The absolute thromboembolic event rates were 2.9% among 5,249 patients treated at either of two U.S. hospitals that used the EHR-based risk calculator and 4.0% in 5,450 patients seen at either of two other U.S. hospitals that served as controls and where usual care method identified patients who needed thromboprophylaxis, said Dr. Spyropoulos, professor and director of the anticoagulation and clinical thrombosis services for Northwell Health in New York. This included a 2.7% rate of venous thromboembolism and a 0.25% rate of arterial thromboembolism in the intervention patients, and a 3.3% rate of venous events and a 0.7% rate of arterial events in the controls.
Patients treated at the hospitals that used the EHR-embedded risk calculator also has a numerically lower rate of major bleeding events during hospitalization and 30-day postdischarge follow-up, a 0.15% rate compared with a 0.22% rate in the control patients, a difference that was not significant.
A ‘powerful message’
“It’s a powerful message to see an absolute 1.1% difference in the rate of thromboembolism and a trend to fewer major bleeds. I think this will change practice,” Dr. Spyropoulos added in the interview. “The next step is dissemination.”
But thromboprophylaxis experts cautioned that, while the results looked promising, the findings need more analysis and review, and the intervention may need further testing before it’s ready for widespread use.
For example, one unexpected result was an unexpected 2.1 percentage point increase in all-cause mortality linked with use of the decision-support tool. Total deaths from admission to 30 days after discharge occurred in 9.1% of the patients treated at the two hospitals that used the risk calculator and 7.0% among the control patients, a difference that Dr, Spyropoulos said was likely the result of unbalanced outcomes from COVID-19 infections that had no relevance to the tested intervention. The trial ran during December 2020–January 2022.
But wait – more detail and analysis needed
“I’d like to see more analysis of the data from this trial,” and “there is the issue of increased mortality,” commented Gregory Piazza, MD, director of vascular medicine at Brigham and Women’s Hospital in Boston, and a specialist in thromboembolism prevention and management. He also highlighted the need for greater detail on the arterial thromboembolic events tallied during the study.
With more details and analysis of these findings “we’ll learn more about the true impact” of this intervention, Dr. Piazza said in an interview.
“The increased mortality in the intervention group may have been due to differential treatment and decision-making and confounding and warrants further investigation,” commented Elaine M. Hylek, MD, a professor at Boston University and designated discussant for the report. Selection bias may have contributed to this possible confounding, Dr. Hylek noted.
Other limitations of the study cited by Dr. Hylek included its reliance on individual clinician decision-making to actually prescribe thromboprophylaxis, a lack of information on patient adherence to their thromboprophylaxis prescription, and an overall low rate of appropriate thromboprophylaxis prescribed to patients at discharge. The rates were 7.5% among the controls and 13.6% among patients in the intervention arm. For prescription at the time of hospitalization, the rates were 72.5% among control patients and 80.1% for patients seen at the two hospitals that used the decision-support tool.
The IMPROVE-DD VTE risk assessment tool
The clinical decision-support tool tested is called the IMPROVE-DD VTE risk assessment model, developed over several years by Dr. Spyropoulos and associates; they have also performed multiple validation studies. The model includes eight factors that score 1-3 points if positive that can add up to total scores of 0-14. A score of 0 or 1 is considered low risk, 2 or 3 intermediate risk, and 4 or more high risk. One of the scoring factors is the result of a D-dimer test, which explains the DD part of the name.
The eight factors and point assignments are prior venous thromboembolism: 3 points; known thrombophilia: 2 points; lower limb paralysis: 2 points; current cancer: 2 points; d-dimer level more than twofold the upper limit of normal: 2 points; immobilized for at least 7 days: 1 point; admitted to the ICU or coronary care unit: 1 point; and age greater than 60 years old: 1 point.
Development of the IMPROVE-DD VTE risk calculator received most of its funding from the U.S. Agency for Healthcare Research and Quality, and the risk tool will be available for hospitals and health systems to access at no charge through the agency’s website, Dr. Spyropoulos said. The researchers designed the calculator to operate in any EHR product.
IMPROVE-DD VTE “is a very valid, high-quality tool,” commented Dr. Piazza. “We’ve used some rather blunt tools in the past,” and especially praised inclusion of D-dimer results into the IMPROVE-DD VTE model.
“It’s nice to use a biomarker in addition to clinical factors,” he said. “A biomarker provides a more holistic picture; we can’t do genetic testing on every patient.”
Enrollment focused on higher-risk patients
The study ran at four academic, tertiary-care hospitals in the Northwell Health network in the New York region. It enrolled patients aged more than 60 years who were hospitalized for any of five diagnoses: heart failure; acute respiratory insufficiency, including chronic obstructive lung disease or asthma; acute infectious disease, including COVID-19; acute inflammatory disease, including rheumatic disease; or acute stroke. The study excluded patients with a history of atrial fibrillation, those who used an anticoagulant at home, or those who had received therapeutic anticoagulation within 24 hours of their hospital admission.
The anticoagulant prophylaxis that patients received depended on their calculated risk level – intermediate or high – and whether they were inpatients or being discharged. The anticoagulants that clinicians could prescribe included unfractionated heparin, enoxaparin, fondaparinux, rivaroxaban, and apixaban.
“We’ve been looking for a long time for a tool for medically ill patients that’s like the CHA2DS2-VASc score” for patients with atrial fibrillation. “These powerful data say we now have this, and the EHR provides a vehicle to easily implement it,” Dr. Spyropoulos said.
The IMPROVE-DD VTE study received partial funding from Janssen. Dr. Spyropoulos has been a consultant to Nayer, Boehringer Ingelheim, Bristol-Myers Squibb, Janssen, Pfizer, and Sanofi; adviser to the ATLAS Group; and has received research support from Janssen. Dr. Piazza has received research funding from Bayer, BIG/EKOS, BMS, Janssen, and Portola. Dr. Hylek had been a consultant to Bayer and Ionis, and has received honoraria from Boehringer Ingelheim and Pfizer.
AT AHA 2022
‘Lucid dying’: EEG backs near-death experience during CPR
“These recalled experiences and brain wave changes may be the first signs of the so-called ‘near-death’ experience, and we have captured them for the first time in a large study,” lead investigator Sam Parnia, MD, PhD, with NYU Langone Health, said in a news release.
Identifying measurable electrical signs of lucid and heightened brain activity during CPR, coupled with stories of recalled near-death experiences, suggests that the human sense of self and consciousness, much like other biological body functions, may not stop completely around the time of death, Dr. Parnia added.
He presented the findings Nov. 6 at a resuscitation science symposium at the American Heart Association scientific sessions.
The AWARE II study
“For years, some people in cardiac arrest have reported being lucid, often with a heightened sense of consciousness, while seemingly unconscious and on the brink of death,” Dr. Parnia noted in an interview.
“Yet, no one’s ever be able to prove it and a lot of people have dismissed these experiences, thinking it’s all just a trick on the brain,” Dr. Parnia said.
In a first-of-its-kind study, Dr. Parnia and colleagues examined consciousness and its underlying electrocortical biomarkers during CPR for in-hospital cardiac arrest (IHCA).
They incorporated independent audiovisual testing of awareness with continuous real-time EEG and cerebral oxygenation (rSO2) monitoring into CPR.
Only 53 of the 567 IHCA patients survived (9.3%). Among the 28 (52.8%) IHCA survivors who completed interviews, 11 (39.3%) reported unique, lucid experiences during resuscitation.
These experiences included a perception of separation from one’s body, observing events without pain or distress, and an awareness and meaningful evaluation of life, including of their actions, intentions, and thoughts toward others.
“These lucid experiences of death are not hallucinations or delusions. They cannot be considered a trick of a disordered or dying brain, but rather a unique human experience that emerges on the brink of death,” Dr. Parnia said.
And what’s “fascinating,” he added, is that despite marked cerebral ischemia (mean regional oxygen saturation [rSO2] 43%), near-normal/physiologic EEG activity (gamma, delta, theta, alpha, and beta rhythms) consistent with consciousness and a possible resumption of a network-level of cognitive and neuronal activity emerged for as long as 35-60 minutes into CPR.
Some of these brain waves normally occur when people are conscious and performing higher mental functions, including thinking, memory retrieval, and conscious perception, he said.
‘Seismic shift’ in understanding of death
This is the first time such biomarkers of consciousness have been identified during cardiac arrest and CPR, Dr. Parnia said.
He said further study is needed to more precisely define biomarkers of what is considered to be clinical consciousness and the recalled experience of death, and to monitor the long-term psychological effects of resuscitation after cardiac arrest.
“Our understanding of death has gone through a seismic shift in the last few years,” he said.
“The biological discoveries around death and the postmortem period are completely different to the social conventions that we have about death. That is, we perceive of death as being the end, but actually what we’re finding is that brain cells don’t die immediately. They die very slowly over many hours of time,” Dr. Parnia noted.
Reached for comment, Ajmal Zemmar, MD, PhD, of University of Louisville (Ky.), noted that several studies, including this one, “challenge the traditional way that we think of death – that when the heart stops beating that’s when we die.”
The observation that during cardiac arrest and CPR, the brain waves are still normal for up to an hour is “fairly remarkable,” Dr. Zemmar told this news organization.
“However, whether there is conscious perception or not is very hard to answer,” he cautioned.
“This type of research tries to bridge the objective EEG recordings with the subjective description you get from the patient, but it’s hard to know when conscious perception stops,” he said.
Funding and support for the study were provided by NYU Langone Health, The John Templeton Foundation, and the UK Resuscitation Council, and National Institutes for Health Research. Dr. Parnia and Dr. Zemmar reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“These recalled experiences and brain wave changes may be the first signs of the so-called ‘near-death’ experience, and we have captured them for the first time in a large study,” lead investigator Sam Parnia, MD, PhD, with NYU Langone Health, said in a news release.
Identifying measurable electrical signs of lucid and heightened brain activity during CPR, coupled with stories of recalled near-death experiences, suggests that the human sense of self and consciousness, much like other biological body functions, may not stop completely around the time of death, Dr. Parnia added.
He presented the findings Nov. 6 at a resuscitation science symposium at the American Heart Association scientific sessions.
The AWARE II study
“For years, some people in cardiac arrest have reported being lucid, often with a heightened sense of consciousness, while seemingly unconscious and on the brink of death,” Dr. Parnia noted in an interview.
“Yet, no one’s ever be able to prove it and a lot of people have dismissed these experiences, thinking it’s all just a trick on the brain,” Dr. Parnia said.
In a first-of-its-kind study, Dr. Parnia and colleagues examined consciousness and its underlying electrocortical biomarkers during CPR for in-hospital cardiac arrest (IHCA).
They incorporated independent audiovisual testing of awareness with continuous real-time EEG and cerebral oxygenation (rSO2) monitoring into CPR.
Only 53 of the 567 IHCA patients survived (9.3%). Among the 28 (52.8%) IHCA survivors who completed interviews, 11 (39.3%) reported unique, lucid experiences during resuscitation.
These experiences included a perception of separation from one’s body, observing events without pain or distress, and an awareness and meaningful evaluation of life, including of their actions, intentions, and thoughts toward others.
“These lucid experiences of death are not hallucinations or delusions. They cannot be considered a trick of a disordered or dying brain, but rather a unique human experience that emerges on the brink of death,” Dr. Parnia said.
And what’s “fascinating,” he added, is that despite marked cerebral ischemia (mean regional oxygen saturation [rSO2] 43%), near-normal/physiologic EEG activity (gamma, delta, theta, alpha, and beta rhythms) consistent with consciousness and a possible resumption of a network-level of cognitive and neuronal activity emerged for as long as 35-60 minutes into CPR.
Some of these brain waves normally occur when people are conscious and performing higher mental functions, including thinking, memory retrieval, and conscious perception, he said.
‘Seismic shift’ in understanding of death
This is the first time such biomarkers of consciousness have been identified during cardiac arrest and CPR, Dr. Parnia said.
He said further study is needed to more precisely define biomarkers of what is considered to be clinical consciousness and the recalled experience of death, and to monitor the long-term psychological effects of resuscitation after cardiac arrest.
“Our understanding of death has gone through a seismic shift in the last few years,” he said.
“The biological discoveries around death and the postmortem period are completely different to the social conventions that we have about death. That is, we perceive of death as being the end, but actually what we’re finding is that brain cells don’t die immediately. They die very slowly over many hours of time,” Dr. Parnia noted.
Reached for comment, Ajmal Zemmar, MD, PhD, of University of Louisville (Ky.), noted that several studies, including this one, “challenge the traditional way that we think of death – that when the heart stops beating that’s when we die.”
The observation that during cardiac arrest and CPR, the brain waves are still normal for up to an hour is “fairly remarkable,” Dr. Zemmar told this news organization.
“However, whether there is conscious perception or not is very hard to answer,” he cautioned.
“This type of research tries to bridge the objective EEG recordings with the subjective description you get from the patient, but it’s hard to know when conscious perception stops,” he said.
Funding and support for the study were provided by NYU Langone Health, The John Templeton Foundation, and the UK Resuscitation Council, and National Institutes for Health Research. Dr. Parnia and Dr. Zemmar reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“These recalled experiences and brain wave changes may be the first signs of the so-called ‘near-death’ experience, and we have captured them for the first time in a large study,” lead investigator Sam Parnia, MD, PhD, with NYU Langone Health, said in a news release.
Identifying measurable electrical signs of lucid and heightened brain activity during CPR, coupled with stories of recalled near-death experiences, suggests that the human sense of self and consciousness, much like other biological body functions, may not stop completely around the time of death, Dr. Parnia added.
He presented the findings Nov. 6 at a resuscitation science symposium at the American Heart Association scientific sessions.
The AWARE II study
“For years, some people in cardiac arrest have reported being lucid, often with a heightened sense of consciousness, while seemingly unconscious and on the brink of death,” Dr. Parnia noted in an interview.
“Yet, no one’s ever be able to prove it and a lot of people have dismissed these experiences, thinking it’s all just a trick on the brain,” Dr. Parnia said.
In a first-of-its-kind study, Dr. Parnia and colleagues examined consciousness and its underlying electrocortical biomarkers during CPR for in-hospital cardiac arrest (IHCA).
They incorporated independent audiovisual testing of awareness with continuous real-time EEG and cerebral oxygenation (rSO2) monitoring into CPR.
Only 53 of the 567 IHCA patients survived (9.3%). Among the 28 (52.8%) IHCA survivors who completed interviews, 11 (39.3%) reported unique, lucid experiences during resuscitation.
These experiences included a perception of separation from one’s body, observing events without pain or distress, and an awareness and meaningful evaluation of life, including of their actions, intentions, and thoughts toward others.
“These lucid experiences of death are not hallucinations or delusions. They cannot be considered a trick of a disordered or dying brain, but rather a unique human experience that emerges on the brink of death,” Dr. Parnia said.
And what’s “fascinating,” he added, is that despite marked cerebral ischemia (mean regional oxygen saturation [rSO2] 43%), near-normal/physiologic EEG activity (gamma, delta, theta, alpha, and beta rhythms) consistent with consciousness and a possible resumption of a network-level of cognitive and neuronal activity emerged for as long as 35-60 minutes into CPR.
Some of these brain waves normally occur when people are conscious and performing higher mental functions, including thinking, memory retrieval, and conscious perception, he said.
‘Seismic shift’ in understanding of death
This is the first time such biomarkers of consciousness have been identified during cardiac arrest and CPR, Dr. Parnia said.
He said further study is needed to more precisely define biomarkers of what is considered to be clinical consciousness and the recalled experience of death, and to monitor the long-term psychological effects of resuscitation after cardiac arrest.
“Our understanding of death has gone through a seismic shift in the last few years,” he said.
“The biological discoveries around death and the postmortem period are completely different to the social conventions that we have about death. That is, we perceive of death as being the end, but actually what we’re finding is that brain cells don’t die immediately. They die very slowly over many hours of time,” Dr. Parnia noted.
Reached for comment, Ajmal Zemmar, MD, PhD, of University of Louisville (Ky.), noted that several studies, including this one, “challenge the traditional way that we think of death – that when the heart stops beating that’s when we die.”
The observation that during cardiac arrest and CPR, the brain waves are still normal for up to an hour is “fairly remarkable,” Dr. Zemmar told this news organization.
“However, whether there is conscious perception or not is very hard to answer,” he cautioned.
“This type of research tries to bridge the objective EEG recordings with the subjective description you get from the patient, but it’s hard to know when conscious perception stops,” he said.
Funding and support for the study were provided by NYU Langone Health, The John Templeton Foundation, and the UK Resuscitation Council, and National Institutes for Health Research. Dr. Parnia and Dr. Zemmar reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AHA 2022
Chinese herbal medicine may offer benefits in STEMI: CTS-AMI
CHICAGO – , the CTS-AMI study suggests.
Compared with those assigned to placebo, Chinese patients assigned to tongxinluo had lower rates of 30-day and 1-year major adverse cardiovascular and cerebrovascular events (MACCE), driven by fewer cardiac deaths. Severe STEMI complications were also lower.
Tongxinluo, which contains 10 or more potential active herbs and insects, did not result in severe adverse effects, including major bleeding.
The results were presented at the American Heart Association scientific sessions by Yuejin Yang, MD, PhD, a professor of cardiology at Fuwai Hospital, National Center for CV Disease, Beijing.
He noted that despite reperfusion and optimal medical therapy, patients with STEMI still face high in-hospital mortality, myocardial no-flow, and reperfusion injury, which have no targeted drugs so far worldwide. In addition, “inadequate implementation of timely revascularization for STEMI in China (50-70%) and other developing countries leaves a substantial infarct size in many patients.”
Tongxinluo has been approved for angina and stroke since 1996 in China. Previous preclinical studies and the investigators’ proof-of-concept ENLEAT trial in STEMI suggested tongxinluo could reduce myocardial no-flow and infarction size and protect the cardiomyocytes, Dr. Yang said.
The CTS-AMI trial was conducted at 124 hospitals in mainland China and evenly randomly assigned 3,797 patients with STEMI or new left bundle-branch block within 24 hours of symptom onset to eight capsules of tongxinluo, 2.08 g, or to placebo plus dual antiplatelet therapy before percutaneous coronary intervention (PCI), thrombolysis, or medical management alone, followed by four capsules thrice daily plus guideline-directed therapy for 12 months.
In the modified intention-to-treat cohort of 1,889 tongxinluo- and 1,888 placebo-treated patients, primary PCI was performed in 94.2% and 92.3%, respectively.
The relative risk of 30-day MACCE was reduced 36% in the tongxinluo group, compared with the placebo group (3.39% vs. 5.24%; RR, 0.64; 95% confidence interval, 0.47-0.88).
Among the primary endpoint components, the relative risk of cardiac death was reduced 30% (2.97% vs. 4.24%; RR, 0.70; 95% CI, 0.50-0.99) and MI reinfarction 65% (0 vs. 9 events; RR, 0.35; 95% CI, 0.13-0.99).
Strokes were similar in the tongxinluo and control groups (4 vs. 9; RR, 0.44; 95% CI, 0.14-1.43) and no patient had emergent coronary revascularization at 30 days.
The benefit of the traditional Chinese compound on the primary endpoint was consistent across subgroups, Dr. Yang reported.
At 30 days, severe STEMI complications (11.79% vs. 14.80%; P = .008) and malignant arrhythmias (7.84% vs. 10.20%; P = .011) were lower in the tongxinluo group, whereas mechanical complications (10 vs. 13; P = .526) and cardiogenic shock (2.37% vs. 3.31%; P =.082) were similar.
At 1 year, hazard ratios favored tongxinluo for MACCE (0.64; 95% CI, 0.49-0.82), cardiac death (0.73; 95% CI, 0.55-0.97), MI reinfarction (0.26; 95% CI, 0.10-0.67), and stroke (0.44; 95% CI, 0.21-0.92).
In terms of safety issues, 41 patients receiving tongxinluo and 52 patients receiving placebo had a serious adverse event (2.17% vs. 2.75%; P = .25).
Except for fewer renal injuries with tongxinluo (3.81% vs. 5.30%; P = .029), there were no significant between-group differences in adverse effects including allergic rash, hepatic injury, prolonged activated partial thromboplastin time or prothrombin time, digestive tract hemorrhage, nausea, diarrhea, and headache or dizziness.
“These findings support the use of tongxinluo as an adjunctive therapy in treating STEMI, at least in China and other developing countries,” Dr. Yang concluded.
Invited discussant Kenneth Mahaffey, MD, associate dean, Stanford (Calif.) University, and director of the Stanford Center for Clinical Research, said the results “likely will support use of tongxinluo in China” but that “more studies are needed in other populations and treatment paradigms.”
Asked for further comment by this news organization, Dr. Mahaffey said, “The surprising thing is where are all the MIs? Where are all the revascularization procedures?”
Usually one would expect MIs in about 1% of patients, or about 40 MIs among the 4,000 patients but, he noted, there were zero MIs in the treatment group and 9 among controls.
“We haven’t seen a 30% reduction in cardiovascular death or overall mortality with a therapy in ages with good background therapy,” Dr. Mahaffey said. “We need to see how they ascertained all those events.”
He noted that the results were based on the modified intention-to-treat cohort, which did not include data on 20 patients allocated to treatment, and showed no difference in ST-segment resolution at 2 hours and only a slight difference at 24 hours.
“So even in this trial, for at least some of the data we’ve gotten already that supports the proposed mechanism, it doesn’t show the benefit on that mechanistic substudy. And that’s why we need to see these echoes, the biomarkers, and probably the angios to see: Did it have any effect on the proposed mechanism?” Dr. Mahaffey said.
Finally, information on background therapy is critical for putting the treatment effect into context for other health systems and populations, he said. “Unfortunately, we need to see some additional information to really understand how this will fit in, even in Chinese therapy for STEMI patients, but definitely not outside of China, particularly in the United States, because I don’t know what their background therapy was.”
The study was funded by the National Key Research and Development Program of China. Tongxinluo and placebo were provided by Yiling Pharmacological. The study was designed, conducted, and analyzed independent of the sponsors. Dr. Yang reports no relevant financial conflicts of interest. Dr. Mahaffey reports research funding from the AHA, Apple, Bayer, CIRM, Eidos, Ferring, Gilead, Idorsia, Johnson & Johnson, Luitpold, PAC-12, Precordior, Sanifit, and Verily; consultancy fees from Amgen, Applied Therapeutics, AstraZeneca, CLS Behring, Elsevier, Fibrogen, Inova, Johnson & Johnson, Lexicon, Myokardia, Novartis, Novo Nordisk, Otsuka, Phasebio, Portola, Quidel, Sanofi, and Theravance; and equity in Precordior.
A version of this article first appeared on Medscape.com.
CHICAGO – , the CTS-AMI study suggests.
Compared with those assigned to placebo, Chinese patients assigned to tongxinluo had lower rates of 30-day and 1-year major adverse cardiovascular and cerebrovascular events (MACCE), driven by fewer cardiac deaths. Severe STEMI complications were also lower.
Tongxinluo, which contains 10 or more potential active herbs and insects, did not result in severe adverse effects, including major bleeding.
The results were presented at the American Heart Association scientific sessions by Yuejin Yang, MD, PhD, a professor of cardiology at Fuwai Hospital, National Center for CV Disease, Beijing.
He noted that despite reperfusion and optimal medical therapy, patients with STEMI still face high in-hospital mortality, myocardial no-flow, and reperfusion injury, which have no targeted drugs so far worldwide. In addition, “inadequate implementation of timely revascularization for STEMI in China (50-70%) and other developing countries leaves a substantial infarct size in many patients.”
Tongxinluo has been approved for angina and stroke since 1996 in China. Previous preclinical studies and the investigators’ proof-of-concept ENLEAT trial in STEMI suggested tongxinluo could reduce myocardial no-flow and infarction size and protect the cardiomyocytes, Dr. Yang said.
The CTS-AMI trial was conducted at 124 hospitals in mainland China and evenly randomly assigned 3,797 patients with STEMI or new left bundle-branch block within 24 hours of symptom onset to eight capsules of tongxinluo, 2.08 g, or to placebo plus dual antiplatelet therapy before percutaneous coronary intervention (PCI), thrombolysis, or medical management alone, followed by four capsules thrice daily plus guideline-directed therapy for 12 months.
In the modified intention-to-treat cohort of 1,889 tongxinluo- and 1,888 placebo-treated patients, primary PCI was performed in 94.2% and 92.3%, respectively.
The relative risk of 30-day MACCE was reduced 36% in the tongxinluo group, compared with the placebo group (3.39% vs. 5.24%; RR, 0.64; 95% confidence interval, 0.47-0.88).
Among the primary endpoint components, the relative risk of cardiac death was reduced 30% (2.97% vs. 4.24%; RR, 0.70; 95% CI, 0.50-0.99) and MI reinfarction 65% (0 vs. 9 events; RR, 0.35; 95% CI, 0.13-0.99).
Strokes were similar in the tongxinluo and control groups (4 vs. 9; RR, 0.44; 95% CI, 0.14-1.43) and no patient had emergent coronary revascularization at 30 days.
The benefit of the traditional Chinese compound on the primary endpoint was consistent across subgroups, Dr. Yang reported.
At 30 days, severe STEMI complications (11.79% vs. 14.80%; P = .008) and malignant arrhythmias (7.84% vs. 10.20%; P = .011) were lower in the tongxinluo group, whereas mechanical complications (10 vs. 13; P = .526) and cardiogenic shock (2.37% vs. 3.31%; P =.082) were similar.
At 1 year, hazard ratios favored tongxinluo for MACCE (0.64; 95% CI, 0.49-0.82), cardiac death (0.73; 95% CI, 0.55-0.97), MI reinfarction (0.26; 95% CI, 0.10-0.67), and stroke (0.44; 95% CI, 0.21-0.92).
In terms of safety issues, 41 patients receiving tongxinluo and 52 patients receiving placebo had a serious adverse event (2.17% vs. 2.75%; P = .25).
Except for fewer renal injuries with tongxinluo (3.81% vs. 5.30%; P = .029), there were no significant between-group differences in adverse effects including allergic rash, hepatic injury, prolonged activated partial thromboplastin time or prothrombin time, digestive tract hemorrhage, nausea, diarrhea, and headache or dizziness.
“These findings support the use of tongxinluo as an adjunctive therapy in treating STEMI, at least in China and other developing countries,” Dr. Yang concluded.
Invited discussant Kenneth Mahaffey, MD, associate dean, Stanford (Calif.) University, and director of the Stanford Center for Clinical Research, said the results “likely will support use of tongxinluo in China” but that “more studies are needed in other populations and treatment paradigms.”
Asked for further comment by this news organization, Dr. Mahaffey said, “The surprising thing is where are all the MIs? Where are all the revascularization procedures?”
Usually one would expect MIs in about 1% of patients, or about 40 MIs among the 4,000 patients but, he noted, there were zero MIs in the treatment group and 9 among controls.
“We haven’t seen a 30% reduction in cardiovascular death or overall mortality with a therapy in ages with good background therapy,” Dr. Mahaffey said. “We need to see how they ascertained all those events.”
He noted that the results were based on the modified intention-to-treat cohort, which did not include data on 20 patients allocated to treatment, and showed no difference in ST-segment resolution at 2 hours and only a slight difference at 24 hours.
“So even in this trial, for at least some of the data we’ve gotten already that supports the proposed mechanism, it doesn’t show the benefit on that mechanistic substudy. And that’s why we need to see these echoes, the biomarkers, and probably the angios to see: Did it have any effect on the proposed mechanism?” Dr. Mahaffey said.
Finally, information on background therapy is critical for putting the treatment effect into context for other health systems and populations, he said. “Unfortunately, we need to see some additional information to really understand how this will fit in, even in Chinese therapy for STEMI patients, but definitely not outside of China, particularly in the United States, because I don’t know what their background therapy was.”
The study was funded by the National Key Research and Development Program of China. Tongxinluo and placebo were provided by Yiling Pharmacological. The study was designed, conducted, and analyzed independent of the sponsors. Dr. Yang reports no relevant financial conflicts of interest. Dr. Mahaffey reports research funding from the AHA, Apple, Bayer, CIRM, Eidos, Ferring, Gilead, Idorsia, Johnson & Johnson, Luitpold, PAC-12, Precordior, Sanifit, and Verily; consultancy fees from Amgen, Applied Therapeutics, AstraZeneca, CLS Behring, Elsevier, Fibrogen, Inova, Johnson & Johnson, Lexicon, Myokardia, Novartis, Novo Nordisk, Otsuka, Phasebio, Portola, Quidel, Sanofi, and Theravance; and equity in Precordior.
A version of this article first appeared on Medscape.com.
CHICAGO – , the CTS-AMI study suggests.
Compared with those assigned to placebo, Chinese patients assigned to tongxinluo had lower rates of 30-day and 1-year major adverse cardiovascular and cerebrovascular events (MACCE), driven by fewer cardiac deaths. Severe STEMI complications were also lower.
Tongxinluo, which contains 10 or more potential active herbs and insects, did not result in severe adverse effects, including major bleeding.
The results were presented at the American Heart Association scientific sessions by Yuejin Yang, MD, PhD, a professor of cardiology at Fuwai Hospital, National Center for CV Disease, Beijing.
He noted that despite reperfusion and optimal medical therapy, patients with STEMI still face high in-hospital mortality, myocardial no-flow, and reperfusion injury, which have no targeted drugs so far worldwide. In addition, “inadequate implementation of timely revascularization for STEMI in China (50-70%) and other developing countries leaves a substantial infarct size in many patients.”
Tongxinluo has been approved for angina and stroke since 1996 in China. Previous preclinical studies and the investigators’ proof-of-concept ENLEAT trial in STEMI suggested tongxinluo could reduce myocardial no-flow and infarction size and protect the cardiomyocytes, Dr. Yang said.
The CTS-AMI trial was conducted at 124 hospitals in mainland China and evenly randomly assigned 3,797 patients with STEMI or new left bundle-branch block within 24 hours of symptom onset to eight capsules of tongxinluo, 2.08 g, or to placebo plus dual antiplatelet therapy before percutaneous coronary intervention (PCI), thrombolysis, or medical management alone, followed by four capsules thrice daily plus guideline-directed therapy for 12 months.
In the modified intention-to-treat cohort of 1,889 tongxinluo- and 1,888 placebo-treated patients, primary PCI was performed in 94.2% and 92.3%, respectively.
The relative risk of 30-day MACCE was reduced 36% in the tongxinluo group, compared with the placebo group (3.39% vs. 5.24%; RR, 0.64; 95% confidence interval, 0.47-0.88).
Among the primary endpoint components, the relative risk of cardiac death was reduced 30% (2.97% vs. 4.24%; RR, 0.70; 95% CI, 0.50-0.99) and MI reinfarction 65% (0 vs. 9 events; RR, 0.35; 95% CI, 0.13-0.99).
Strokes were similar in the tongxinluo and control groups (4 vs. 9; RR, 0.44; 95% CI, 0.14-1.43) and no patient had emergent coronary revascularization at 30 days.
The benefit of the traditional Chinese compound on the primary endpoint was consistent across subgroups, Dr. Yang reported.
At 30 days, severe STEMI complications (11.79% vs. 14.80%; P = .008) and malignant arrhythmias (7.84% vs. 10.20%; P = .011) were lower in the tongxinluo group, whereas mechanical complications (10 vs. 13; P = .526) and cardiogenic shock (2.37% vs. 3.31%; P =.082) were similar.
At 1 year, hazard ratios favored tongxinluo for MACCE (0.64; 95% CI, 0.49-0.82), cardiac death (0.73; 95% CI, 0.55-0.97), MI reinfarction (0.26; 95% CI, 0.10-0.67), and stroke (0.44; 95% CI, 0.21-0.92).
In terms of safety issues, 41 patients receiving tongxinluo and 52 patients receiving placebo had a serious adverse event (2.17% vs. 2.75%; P = .25).
Except for fewer renal injuries with tongxinluo (3.81% vs. 5.30%; P = .029), there were no significant between-group differences in adverse effects including allergic rash, hepatic injury, prolonged activated partial thromboplastin time or prothrombin time, digestive tract hemorrhage, nausea, diarrhea, and headache or dizziness.
“These findings support the use of tongxinluo as an adjunctive therapy in treating STEMI, at least in China and other developing countries,” Dr. Yang concluded.
Invited discussant Kenneth Mahaffey, MD, associate dean, Stanford (Calif.) University, and director of the Stanford Center for Clinical Research, said the results “likely will support use of tongxinluo in China” but that “more studies are needed in other populations and treatment paradigms.”
Asked for further comment by this news organization, Dr. Mahaffey said, “The surprising thing is where are all the MIs? Where are all the revascularization procedures?”
Usually one would expect MIs in about 1% of patients, or about 40 MIs among the 4,000 patients but, he noted, there were zero MIs in the treatment group and 9 among controls.
“We haven’t seen a 30% reduction in cardiovascular death or overall mortality with a therapy in ages with good background therapy,” Dr. Mahaffey said. “We need to see how they ascertained all those events.”
He noted that the results were based on the modified intention-to-treat cohort, which did not include data on 20 patients allocated to treatment, and showed no difference in ST-segment resolution at 2 hours and only a slight difference at 24 hours.
“So even in this trial, for at least some of the data we’ve gotten already that supports the proposed mechanism, it doesn’t show the benefit on that mechanistic substudy. And that’s why we need to see these echoes, the biomarkers, and probably the angios to see: Did it have any effect on the proposed mechanism?” Dr. Mahaffey said.
Finally, information on background therapy is critical for putting the treatment effect into context for other health systems and populations, he said. “Unfortunately, we need to see some additional information to really understand how this will fit in, even in Chinese therapy for STEMI patients, but definitely not outside of China, particularly in the United States, because I don’t know what their background therapy was.”
The study was funded by the National Key Research and Development Program of China. Tongxinluo and placebo were provided by Yiling Pharmacological. The study was designed, conducted, and analyzed independent of the sponsors. Dr. Yang reports no relevant financial conflicts of interest. Dr. Mahaffey reports research funding from the AHA, Apple, Bayer, CIRM, Eidos, Ferring, Gilead, Idorsia, Johnson & Johnson, Luitpold, PAC-12, Precordior, Sanifit, and Verily; consultancy fees from Amgen, Applied Therapeutics, AstraZeneca, CLS Behring, Elsevier, Fibrogen, Inova, Johnson & Johnson, Lexicon, Myokardia, Novartis, Novo Nordisk, Otsuka, Phasebio, Portola, Quidel, Sanofi, and Theravance; and equity in Precordior.
A version of this article first appeared on Medscape.com.
AT AHA 2022