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‘Shed the Lead’ and the Injuries. Should Cath Labs Go Lead-Free?
“I’d probably be a quadriplegic,” Dean J. Kereiakes, MD, an interventional cardiologist, said when asked what would have happened if two top neurosurgeons at his hospital hadn’t rushed him to the operating room (OR) for a cervical decompression in February this year.
Dr. Kereiakes had orthopedic problems for years due to the heavy lead aprons he wore in the cath lab. He regularly dosed himself with steroids for disc pain so he could stand up straight and continue to do procedures. “Several times a year I’d go on a tapering dose of prednisone of about 10 days to 2 weeks, and this would take care of it.”
But then his luck ran out. “I’m told in retrospect that my gait — the way I walked — was different, and I was also having some myoclonic jerking in my legs when I was going to sleep. I thought it was peculiar, but I didn’t really tie it together that this was an upper tract injury response.”
At a restaurant with his wife, he found himself unable to sign the check. “I couldn’t write my name.” By the next morning, “I had a floppy right foot, and as I turned around to put my scrubs on, everything fell apart. My arms began to not function and my legs — I couldn’t walk.”
Admitted to The Christ Hospital Heart & Vascular Center in Cincinnati — the very hospital he works in — Dr. Kereiakes had CT and MRI scans and consulted with neurosurgeons he counts as friends. He was given extremely high doses of intravenous steroids. “But instead of getting better, the pain came back, and I started posturing — when you posture, it looks like a praying mantis, your arms are flexed up, your wrists are flexed, and your fingers are spasmed together.” His wife and the nurses couldn’t pull his fingers open, “so they rolled me back, and the posturing started to go away.”
This prompted the neurosurgeons to bring him to the OR “by 6 a.m., and they are ‘unzipping me in the back’ to basically get my spinal cord off my spine. I had cord compression at C2-3 and C 6-7.”
Postop, Dr. Kereiakes couldn’t move his right leg and couldn’t close any of his fingers. “You lose control of things like bladder and bowel function — you have a catheter in — and you say to yourself, ‘How am I going to live like this?.’ ”
The quick-thinking of his neurosurgeons prevented permanent paralysis, and after a long 6-month recovery, Dr. Kereiakes is back in the cath lab, performing procedures. But crucially, he will no longer have to wear a lead apron.
Ending Careers Early. A Catalyst for Change
Typically, interventional cardiologists, interventional radiologists, electrophysiologists, and others working in labs where they are exposed to ionizing radiation wear lead aprons and garments, such as thyroid collars, leaded caps, and glasses, to protect them during procedures.
Long-term occupational exposure to radiation is linked to cataracts; brain tumors; cancers, including leukemia, multiple myelomas, lymphomas, and thyroid cancers; and left-sided breast cancers in women because the aprons don’t always cover the left side of the chest adequately.
Individual states set the standards in terms of the thickness of the lead required, varying from 0.25- to 0.5-mm–lead-equivalent aprons, which reduce exposure by 85%-95%. Radiation safety officers monitor the badges that staff wear to record their radiation exposure and will warn them when their levels are too high.
But — as Dr. Kereiakes freely admits — ambitious interventionalists don’t always take much notice. “They would come and say, ‘Hey your badge is really high,’ and so I would just put it in a drawer and carry on,” he said. “When you are younger, you feel immortal.”
James B. Hermiller Jr., MD, president of the Society for Cardiovascular Angiography & Interventions (SCAI), agrees: “The feeling is that, with lead, you are indestructible, and no one wants to show any weakness.”
Another occupational hazard related to those protective lead aprons was also being ignored, that of orthopedic injury. In surveys done by SCAI, around half of interventional cardiology respondents report cervical, lumbar, hip, knee, or ankle joint injuries.
While Dr. Kereiakes recognizes likely bias — with those afflicted more likely to complete these surveys — he believes that the problem is huge and “is ending careers early.”
“It’s interesting that radiation is at the forefront of protection and occupational safety, but you are much more likely to be taken out of work because of orthopedic injury,” explained Dr. Hermiller, director of Structural Heart Program at Ascension St. Vincent Heart Center in Indianapolis.
His own story “is not as compelling as Dean’s, but 17 years ago, I ruptured a disk in my lower spine and had emergent surgery and I now need a neck surgery.”
Dr. Hermiller’s hospital, too, has purchased multiple radiation protection systems. “If you want to do this job for 30 years, you have to protect yourself early and at all times,” he said.
His focus as SCAI president is to help get these protection systems in place at more hospitals.
But significant challenges remain, not least the cost, which can be $150,000-$200,000 per lab. He estimates that fewer than 10% US hospitals with cath and other labs using radiation have installed such systems.
Most systems are not US Food and Drug Administration (FDA) approved because they are not attached to equipment in the cath lab, something that Nadia Sutton, MD, MPH, chair of the SCAI Women in Innovations committee, said many physicians are not aware of. “The companies [marketing the systems] are telling us that we can ‘shed our lead,’ ” she said. “It could be safe, but we are using the data provided by the companies.”
How Do the Lead-Free Systems Work?
Currently, there are three main radiation protection systems available. The Protego Radiation Protection System (Image Diagnostics), the EggNest Protect (Egg Medical), and the Rampart (Rampart ic).
According to Dr. Kereiakes, they differ somewhat in whether they allow immediate access to the patient or whether you can see and interact with them. He explained that in high-risk procedures, easy access is desirable. “If you get a perforation or tamponade and the patient suddenly goes ‘out,’ you need to be able to get to them quickly, and you can’t be spending a lot of time taking the shielding down.”
Dr. Kereiakes was recovering in the hospital when his colleagues plumped for the EggNest system. He thinks they chose it because it offers visibility and access to the patient and “takes 4-5 minutes, maximum, to set up.” So far, he agrees with the choice but wants to “give it a real, volume-driven try.”
If they are satisfied with the system, the hospital will order six more by the end of the year, he said. A significant financial undertaking, he acknowledged.
Dr. Hermiller cited data for the Rampart system showing a 95% reduction in radiation without any lead. For an average 1-GRAY radiation exposure case, “if you wear lead, you reach the maximum dose of radiation around 850 cases in a year. If you do it with one of these protection systems, in this case Rampart, you can do 14,500 cases in a year. Not that anyone would do that [many].”
The Protego system has very similar data, he noted. The systems protect the operator and whoever is scrubbing in at the table, so those on the other side of the protector still need to wear lead, Dr. Hermiller stressed.
Data for the EggNest Protect are available but are as yet unpublished.
Dr. Hermiller acknowledged that there is still a long way to go in getting hospitals to spend the money on these systems, but he thinks cath lab operators will drive the change.
“At our SCAI meeting this year, the biggest attendance was at a session about a lead-free cath lab environment.”
Regulation at the State Level
Despite the excitement among the profession, Dr. Sutton — director of Interventional Cardiology Research in the Division of Cardiovascular Medicine at Vanderbilt University Medical Center, Nashville, Tennessee — still has concerns about the lack of FDA regulation.
There is one newer system, called the Radiaction shield system, that attaches to the existing equipment so that is regulated by the FDA as a class II device, she noted. “But it is my understanding that the Protego, Rampart, and EggNest are Class I Exempt. That is the same category as Band-Aid.”
James Beabout, MBA, chief marketing officer, Egg Medical, confirmed that the EggNest “is classified as a Class I device which does not require FDA approval. That leaves regulation to each state regarding the requirements for protective aprons.” And Mark Hansen, vice president business development, of Image Diagnostics — the manufacturer of the Protego Radiation Protection System — confirmed that “the real governance is at the state level.”
The company petitions the state regulator for an exemption letter to the wearing of lead aprons. “In some cases, the state will come to the site directly and validate the systems integrity and to confirm their decision. Once the exemption is granted, the state sends a document, and it’s the responsibility of the sites’ Radiation Safety Officer (RSO) to change the labs safety process and rules,” Mr. Hansen explained.
“What really makes this work is a real-time dosimetry from Fluke Medical. Staff wear one to two badges that instantly detects exposure,” Mr. Hansen stressed.
Similarly, said Mr. Beabout, Egg Medical has data from over 1000 real-world cases collected using real-time dosimetry (RaySafe i3 system) which demonstrate that it is possible to get some people in the room out of protective aprons, where allowed. They recommend real-time dosimetry anytime people are removing their aprons, “since the patient BMI, x-ray system type/age, and complexity of the case all have a significant effect on the radiation dose in each case.” Their goal is for exposure to be zero or as close to zero as possible, “otherwise we recommend use of protective aprons. With the EggNest, operators can use much lighter aprons (0.125 mm sold by Burlington Medical) than what has traditionally been used, so that is also an option,” he said.
Dr. Hermiller said the SCAI plan is to produce several statements on going lead-free, with all other interested professional societies — such as those representing interventional radiologists and vascular surgeons, as well as all the major cardiology societies.
“We want to make an intellectual foundation for this,” Dr. Hermiller explained. Guidelines “are in the making,” he said, with the expectation that they will be ready by the end of this year or early next year.
SCAI will also work with the 50 US states to facilitate lead-free labs, “as each one has a different way to be approved to go without lead,” he noted.
“This is not going to go away, it’s going to build in force, through the societies,” said Dr. Kereiakes. “It’s a matter of workplace safety.” He doesn’t think that the federal Occupational Health and Safety Administration does much to protect doctors, nurses, and technicians in the cath and other labs.
Dr. Hermiller agreed: “I always say that if we were a GM car plant, they would shut us down.”
Dr. Hermiller also stressed the expense of having doctors and other staff off work with occupation-related injuries. He has already observed that “it’s much easier to recruit cath lab staff to a place where they don’t have to wear lead.”
He anticipates that the next generation of physicians “are going to demand places where they don’t have to wear lead.” He is also hopeful that it will result in more women choosing interventional cardiology: “Women are safe in the cath lab with current lead systems, but if we could move to this, there would be even more women participating.”
Pregnancy Safe in the Cath Lab
Dr. Sutton reiterated his point: “The number-one message that I want to get across is that it is considered safe for the unborn baby, being in the cath lab, under lead,” she said, noting that there are very good data that the amount of lead that is required by states results in negligible radiation exposure to the developing fetus.
She had her children before working in the cath lab, “but I’ve heard from other women: It’s heavy and its sweaty for prolonged periods of time, but it can be done and you can get through it,” she said. Although the promise of radiation protection systems “is exciting, we have to approach this with some level of caution or awareness,” she said. “Cardiologists come from a cardiology background. We are not radiologists who go through a radiology residency, like IRs do. They get a lot of training on radiation exposure and what it means,” Dr. Sutton stressed.
Dr. Kereiakes, for his part, remains enthusiastic. He returned to the cath lab in August, just 6 months after his brush with near quadriplegia. “This is what I’ve spent my life doing and I love doing it, and I’m not ready to quit.”
Dr. Hermiller, Dr. Kereiakes, and Dr. Sutton reported having no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
“I’d probably be a quadriplegic,” Dean J. Kereiakes, MD, an interventional cardiologist, said when asked what would have happened if two top neurosurgeons at his hospital hadn’t rushed him to the operating room (OR) for a cervical decompression in February this year.
Dr. Kereiakes had orthopedic problems for years due to the heavy lead aprons he wore in the cath lab. He regularly dosed himself with steroids for disc pain so he could stand up straight and continue to do procedures. “Several times a year I’d go on a tapering dose of prednisone of about 10 days to 2 weeks, and this would take care of it.”
But then his luck ran out. “I’m told in retrospect that my gait — the way I walked — was different, and I was also having some myoclonic jerking in my legs when I was going to sleep. I thought it was peculiar, but I didn’t really tie it together that this was an upper tract injury response.”
At a restaurant with his wife, he found himself unable to sign the check. “I couldn’t write my name.” By the next morning, “I had a floppy right foot, and as I turned around to put my scrubs on, everything fell apart. My arms began to not function and my legs — I couldn’t walk.”
Admitted to The Christ Hospital Heart & Vascular Center in Cincinnati — the very hospital he works in — Dr. Kereiakes had CT and MRI scans and consulted with neurosurgeons he counts as friends. He was given extremely high doses of intravenous steroids. “But instead of getting better, the pain came back, and I started posturing — when you posture, it looks like a praying mantis, your arms are flexed up, your wrists are flexed, and your fingers are spasmed together.” His wife and the nurses couldn’t pull his fingers open, “so they rolled me back, and the posturing started to go away.”
This prompted the neurosurgeons to bring him to the OR “by 6 a.m., and they are ‘unzipping me in the back’ to basically get my spinal cord off my spine. I had cord compression at C2-3 and C 6-7.”
Postop, Dr. Kereiakes couldn’t move his right leg and couldn’t close any of his fingers. “You lose control of things like bladder and bowel function — you have a catheter in — and you say to yourself, ‘How am I going to live like this?.’ ”
The quick-thinking of his neurosurgeons prevented permanent paralysis, and after a long 6-month recovery, Dr. Kereiakes is back in the cath lab, performing procedures. But crucially, he will no longer have to wear a lead apron.
Ending Careers Early. A Catalyst for Change
Typically, interventional cardiologists, interventional radiologists, electrophysiologists, and others working in labs where they are exposed to ionizing radiation wear lead aprons and garments, such as thyroid collars, leaded caps, and glasses, to protect them during procedures.
Long-term occupational exposure to radiation is linked to cataracts; brain tumors; cancers, including leukemia, multiple myelomas, lymphomas, and thyroid cancers; and left-sided breast cancers in women because the aprons don’t always cover the left side of the chest adequately.
Individual states set the standards in terms of the thickness of the lead required, varying from 0.25- to 0.5-mm–lead-equivalent aprons, which reduce exposure by 85%-95%. Radiation safety officers monitor the badges that staff wear to record their radiation exposure and will warn them when their levels are too high.
But — as Dr. Kereiakes freely admits — ambitious interventionalists don’t always take much notice. “They would come and say, ‘Hey your badge is really high,’ and so I would just put it in a drawer and carry on,” he said. “When you are younger, you feel immortal.”
James B. Hermiller Jr., MD, president of the Society for Cardiovascular Angiography & Interventions (SCAI), agrees: “The feeling is that, with lead, you are indestructible, and no one wants to show any weakness.”
Another occupational hazard related to those protective lead aprons was also being ignored, that of orthopedic injury. In surveys done by SCAI, around half of interventional cardiology respondents report cervical, lumbar, hip, knee, or ankle joint injuries.
While Dr. Kereiakes recognizes likely bias — with those afflicted more likely to complete these surveys — he believes that the problem is huge and “is ending careers early.”
“It’s interesting that radiation is at the forefront of protection and occupational safety, but you are much more likely to be taken out of work because of orthopedic injury,” explained Dr. Hermiller, director of Structural Heart Program at Ascension St. Vincent Heart Center in Indianapolis.
His own story “is not as compelling as Dean’s, but 17 years ago, I ruptured a disk in my lower spine and had emergent surgery and I now need a neck surgery.”
Dr. Hermiller’s hospital, too, has purchased multiple radiation protection systems. “If you want to do this job for 30 years, you have to protect yourself early and at all times,” he said.
His focus as SCAI president is to help get these protection systems in place at more hospitals.
But significant challenges remain, not least the cost, which can be $150,000-$200,000 per lab. He estimates that fewer than 10% US hospitals with cath and other labs using radiation have installed such systems.
Most systems are not US Food and Drug Administration (FDA) approved because they are not attached to equipment in the cath lab, something that Nadia Sutton, MD, MPH, chair of the SCAI Women in Innovations committee, said many physicians are not aware of. “The companies [marketing the systems] are telling us that we can ‘shed our lead,’ ” she said. “It could be safe, but we are using the data provided by the companies.”
How Do the Lead-Free Systems Work?
Currently, there are three main radiation protection systems available. The Protego Radiation Protection System (Image Diagnostics), the EggNest Protect (Egg Medical), and the Rampart (Rampart ic).
According to Dr. Kereiakes, they differ somewhat in whether they allow immediate access to the patient or whether you can see and interact with them. He explained that in high-risk procedures, easy access is desirable. “If you get a perforation or tamponade and the patient suddenly goes ‘out,’ you need to be able to get to them quickly, and you can’t be spending a lot of time taking the shielding down.”
Dr. Kereiakes was recovering in the hospital when his colleagues plumped for the EggNest system. He thinks they chose it because it offers visibility and access to the patient and “takes 4-5 minutes, maximum, to set up.” So far, he agrees with the choice but wants to “give it a real, volume-driven try.”
If they are satisfied with the system, the hospital will order six more by the end of the year, he said. A significant financial undertaking, he acknowledged.
Dr. Hermiller cited data for the Rampart system showing a 95% reduction in radiation without any lead. For an average 1-GRAY radiation exposure case, “if you wear lead, you reach the maximum dose of radiation around 850 cases in a year. If you do it with one of these protection systems, in this case Rampart, you can do 14,500 cases in a year. Not that anyone would do that [many].”
The Protego system has very similar data, he noted. The systems protect the operator and whoever is scrubbing in at the table, so those on the other side of the protector still need to wear lead, Dr. Hermiller stressed.
Data for the EggNest Protect are available but are as yet unpublished.
Dr. Hermiller acknowledged that there is still a long way to go in getting hospitals to spend the money on these systems, but he thinks cath lab operators will drive the change.
“At our SCAI meeting this year, the biggest attendance was at a session about a lead-free cath lab environment.”
Regulation at the State Level
Despite the excitement among the profession, Dr. Sutton — director of Interventional Cardiology Research in the Division of Cardiovascular Medicine at Vanderbilt University Medical Center, Nashville, Tennessee — still has concerns about the lack of FDA regulation.
There is one newer system, called the Radiaction shield system, that attaches to the existing equipment so that is regulated by the FDA as a class II device, she noted. “But it is my understanding that the Protego, Rampart, and EggNest are Class I Exempt. That is the same category as Band-Aid.”
James Beabout, MBA, chief marketing officer, Egg Medical, confirmed that the EggNest “is classified as a Class I device which does not require FDA approval. That leaves regulation to each state regarding the requirements for protective aprons.” And Mark Hansen, vice president business development, of Image Diagnostics — the manufacturer of the Protego Radiation Protection System — confirmed that “the real governance is at the state level.”
The company petitions the state regulator for an exemption letter to the wearing of lead aprons. “In some cases, the state will come to the site directly and validate the systems integrity and to confirm their decision. Once the exemption is granted, the state sends a document, and it’s the responsibility of the sites’ Radiation Safety Officer (RSO) to change the labs safety process and rules,” Mr. Hansen explained.
“What really makes this work is a real-time dosimetry from Fluke Medical. Staff wear one to two badges that instantly detects exposure,” Mr. Hansen stressed.
Similarly, said Mr. Beabout, Egg Medical has data from over 1000 real-world cases collected using real-time dosimetry (RaySafe i3 system) which demonstrate that it is possible to get some people in the room out of protective aprons, where allowed. They recommend real-time dosimetry anytime people are removing their aprons, “since the patient BMI, x-ray system type/age, and complexity of the case all have a significant effect on the radiation dose in each case.” Their goal is for exposure to be zero or as close to zero as possible, “otherwise we recommend use of protective aprons. With the EggNest, operators can use much lighter aprons (0.125 mm sold by Burlington Medical) than what has traditionally been used, so that is also an option,” he said.
Dr. Hermiller said the SCAI plan is to produce several statements on going lead-free, with all other interested professional societies — such as those representing interventional radiologists and vascular surgeons, as well as all the major cardiology societies.
“We want to make an intellectual foundation for this,” Dr. Hermiller explained. Guidelines “are in the making,” he said, with the expectation that they will be ready by the end of this year or early next year.
SCAI will also work with the 50 US states to facilitate lead-free labs, “as each one has a different way to be approved to go without lead,” he noted.
“This is not going to go away, it’s going to build in force, through the societies,” said Dr. Kereiakes. “It’s a matter of workplace safety.” He doesn’t think that the federal Occupational Health and Safety Administration does much to protect doctors, nurses, and technicians in the cath and other labs.
Dr. Hermiller agreed: “I always say that if we were a GM car plant, they would shut us down.”
Dr. Hermiller also stressed the expense of having doctors and other staff off work with occupation-related injuries. He has already observed that “it’s much easier to recruit cath lab staff to a place where they don’t have to wear lead.”
He anticipates that the next generation of physicians “are going to demand places where they don’t have to wear lead.” He is also hopeful that it will result in more women choosing interventional cardiology: “Women are safe in the cath lab with current lead systems, but if we could move to this, there would be even more women participating.”
Pregnancy Safe in the Cath Lab
Dr. Sutton reiterated his point: “The number-one message that I want to get across is that it is considered safe for the unborn baby, being in the cath lab, under lead,” she said, noting that there are very good data that the amount of lead that is required by states results in negligible radiation exposure to the developing fetus.
She had her children before working in the cath lab, “but I’ve heard from other women: It’s heavy and its sweaty for prolonged periods of time, but it can be done and you can get through it,” she said. Although the promise of radiation protection systems “is exciting, we have to approach this with some level of caution or awareness,” she said. “Cardiologists come from a cardiology background. We are not radiologists who go through a radiology residency, like IRs do. They get a lot of training on radiation exposure and what it means,” Dr. Sutton stressed.
Dr. Kereiakes, for his part, remains enthusiastic. He returned to the cath lab in August, just 6 months after his brush with near quadriplegia. “This is what I’ve spent my life doing and I love doing it, and I’m not ready to quit.”
Dr. Hermiller, Dr. Kereiakes, and Dr. Sutton reported having no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
“I’d probably be a quadriplegic,” Dean J. Kereiakes, MD, an interventional cardiologist, said when asked what would have happened if two top neurosurgeons at his hospital hadn’t rushed him to the operating room (OR) for a cervical decompression in February this year.
Dr. Kereiakes had orthopedic problems for years due to the heavy lead aprons he wore in the cath lab. He regularly dosed himself with steroids for disc pain so he could stand up straight and continue to do procedures. “Several times a year I’d go on a tapering dose of prednisone of about 10 days to 2 weeks, and this would take care of it.”
But then his luck ran out. “I’m told in retrospect that my gait — the way I walked — was different, and I was also having some myoclonic jerking in my legs when I was going to sleep. I thought it was peculiar, but I didn’t really tie it together that this was an upper tract injury response.”
At a restaurant with his wife, he found himself unable to sign the check. “I couldn’t write my name.” By the next morning, “I had a floppy right foot, and as I turned around to put my scrubs on, everything fell apart. My arms began to not function and my legs — I couldn’t walk.”
Admitted to The Christ Hospital Heart & Vascular Center in Cincinnati — the very hospital he works in — Dr. Kereiakes had CT and MRI scans and consulted with neurosurgeons he counts as friends. He was given extremely high doses of intravenous steroids. “But instead of getting better, the pain came back, and I started posturing — when you posture, it looks like a praying mantis, your arms are flexed up, your wrists are flexed, and your fingers are spasmed together.” His wife and the nurses couldn’t pull his fingers open, “so they rolled me back, and the posturing started to go away.”
This prompted the neurosurgeons to bring him to the OR “by 6 a.m., and they are ‘unzipping me in the back’ to basically get my spinal cord off my spine. I had cord compression at C2-3 and C 6-7.”
Postop, Dr. Kereiakes couldn’t move his right leg and couldn’t close any of his fingers. “You lose control of things like bladder and bowel function — you have a catheter in — and you say to yourself, ‘How am I going to live like this?.’ ”
The quick-thinking of his neurosurgeons prevented permanent paralysis, and after a long 6-month recovery, Dr. Kereiakes is back in the cath lab, performing procedures. But crucially, he will no longer have to wear a lead apron.
Ending Careers Early. A Catalyst for Change
Typically, interventional cardiologists, interventional radiologists, electrophysiologists, and others working in labs where they are exposed to ionizing radiation wear lead aprons and garments, such as thyroid collars, leaded caps, and glasses, to protect them during procedures.
Long-term occupational exposure to radiation is linked to cataracts; brain tumors; cancers, including leukemia, multiple myelomas, lymphomas, and thyroid cancers; and left-sided breast cancers in women because the aprons don’t always cover the left side of the chest adequately.
Individual states set the standards in terms of the thickness of the lead required, varying from 0.25- to 0.5-mm–lead-equivalent aprons, which reduce exposure by 85%-95%. Radiation safety officers monitor the badges that staff wear to record their radiation exposure and will warn them when their levels are too high.
But — as Dr. Kereiakes freely admits — ambitious interventionalists don’t always take much notice. “They would come and say, ‘Hey your badge is really high,’ and so I would just put it in a drawer and carry on,” he said. “When you are younger, you feel immortal.”
James B. Hermiller Jr., MD, president of the Society for Cardiovascular Angiography & Interventions (SCAI), agrees: “The feeling is that, with lead, you are indestructible, and no one wants to show any weakness.”
Another occupational hazard related to those protective lead aprons was also being ignored, that of orthopedic injury. In surveys done by SCAI, around half of interventional cardiology respondents report cervical, lumbar, hip, knee, or ankle joint injuries.
While Dr. Kereiakes recognizes likely bias — with those afflicted more likely to complete these surveys — he believes that the problem is huge and “is ending careers early.”
“It’s interesting that radiation is at the forefront of protection and occupational safety, but you are much more likely to be taken out of work because of orthopedic injury,” explained Dr. Hermiller, director of Structural Heart Program at Ascension St. Vincent Heart Center in Indianapolis.
His own story “is not as compelling as Dean’s, but 17 years ago, I ruptured a disk in my lower spine and had emergent surgery and I now need a neck surgery.”
Dr. Hermiller’s hospital, too, has purchased multiple radiation protection systems. “If you want to do this job for 30 years, you have to protect yourself early and at all times,” he said.
His focus as SCAI president is to help get these protection systems in place at more hospitals.
But significant challenges remain, not least the cost, which can be $150,000-$200,000 per lab. He estimates that fewer than 10% US hospitals with cath and other labs using radiation have installed such systems.
Most systems are not US Food and Drug Administration (FDA) approved because they are not attached to equipment in the cath lab, something that Nadia Sutton, MD, MPH, chair of the SCAI Women in Innovations committee, said many physicians are not aware of. “The companies [marketing the systems] are telling us that we can ‘shed our lead,’ ” she said. “It could be safe, but we are using the data provided by the companies.”
How Do the Lead-Free Systems Work?
Currently, there are three main radiation protection systems available. The Protego Radiation Protection System (Image Diagnostics), the EggNest Protect (Egg Medical), and the Rampart (Rampart ic).
According to Dr. Kereiakes, they differ somewhat in whether they allow immediate access to the patient or whether you can see and interact with them. He explained that in high-risk procedures, easy access is desirable. “If you get a perforation or tamponade and the patient suddenly goes ‘out,’ you need to be able to get to them quickly, and you can’t be spending a lot of time taking the shielding down.”
Dr. Kereiakes was recovering in the hospital when his colleagues plumped for the EggNest system. He thinks they chose it because it offers visibility and access to the patient and “takes 4-5 minutes, maximum, to set up.” So far, he agrees with the choice but wants to “give it a real, volume-driven try.”
If they are satisfied with the system, the hospital will order six more by the end of the year, he said. A significant financial undertaking, he acknowledged.
Dr. Hermiller cited data for the Rampart system showing a 95% reduction in radiation without any lead. For an average 1-GRAY radiation exposure case, “if you wear lead, you reach the maximum dose of radiation around 850 cases in a year. If you do it with one of these protection systems, in this case Rampart, you can do 14,500 cases in a year. Not that anyone would do that [many].”
The Protego system has very similar data, he noted. The systems protect the operator and whoever is scrubbing in at the table, so those on the other side of the protector still need to wear lead, Dr. Hermiller stressed.
Data for the EggNest Protect are available but are as yet unpublished.
Dr. Hermiller acknowledged that there is still a long way to go in getting hospitals to spend the money on these systems, but he thinks cath lab operators will drive the change.
“At our SCAI meeting this year, the biggest attendance was at a session about a lead-free cath lab environment.”
Regulation at the State Level
Despite the excitement among the profession, Dr. Sutton — director of Interventional Cardiology Research in the Division of Cardiovascular Medicine at Vanderbilt University Medical Center, Nashville, Tennessee — still has concerns about the lack of FDA regulation.
There is one newer system, called the Radiaction shield system, that attaches to the existing equipment so that is regulated by the FDA as a class II device, she noted. “But it is my understanding that the Protego, Rampart, and EggNest are Class I Exempt. That is the same category as Band-Aid.”
James Beabout, MBA, chief marketing officer, Egg Medical, confirmed that the EggNest “is classified as a Class I device which does not require FDA approval. That leaves regulation to each state regarding the requirements for protective aprons.” And Mark Hansen, vice president business development, of Image Diagnostics — the manufacturer of the Protego Radiation Protection System — confirmed that “the real governance is at the state level.”
The company petitions the state regulator for an exemption letter to the wearing of lead aprons. “In some cases, the state will come to the site directly and validate the systems integrity and to confirm their decision. Once the exemption is granted, the state sends a document, and it’s the responsibility of the sites’ Radiation Safety Officer (RSO) to change the labs safety process and rules,” Mr. Hansen explained.
“What really makes this work is a real-time dosimetry from Fluke Medical. Staff wear one to two badges that instantly detects exposure,” Mr. Hansen stressed.
Similarly, said Mr. Beabout, Egg Medical has data from over 1000 real-world cases collected using real-time dosimetry (RaySafe i3 system) which demonstrate that it is possible to get some people in the room out of protective aprons, where allowed. They recommend real-time dosimetry anytime people are removing their aprons, “since the patient BMI, x-ray system type/age, and complexity of the case all have a significant effect on the radiation dose in each case.” Their goal is for exposure to be zero or as close to zero as possible, “otherwise we recommend use of protective aprons. With the EggNest, operators can use much lighter aprons (0.125 mm sold by Burlington Medical) than what has traditionally been used, so that is also an option,” he said.
Dr. Hermiller said the SCAI plan is to produce several statements on going lead-free, with all other interested professional societies — such as those representing interventional radiologists and vascular surgeons, as well as all the major cardiology societies.
“We want to make an intellectual foundation for this,” Dr. Hermiller explained. Guidelines “are in the making,” he said, with the expectation that they will be ready by the end of this year or early next year.
SCAI will also work with the 50 US states to facilitate lead-free labs, “as each one has a different way to be approved to go without lead,” he noted.
“This is not going to go away, it’s going to build in force, through the societies,” said Dr. Kereiakes. “It’s a matter of workplace safety.” He doesn’t think that the federal Occupational Health and Safety Administration does much to protect doctors, nurses, and technicians in the cath and other labs.
Dr. Hermiller agreed: “I always say that if we were a GM car plant, they would shut us down.”
Dr. Hermiller also stressed the expense of having doctors and other staff off work with occupation-related injuries. He has already observed that “it’s much easier to recruit cath lab staff to a place where they don’t have to wear lead.”
He anticipates that the next generation of physicians “are going to demand places where they don’t have to wear lead.” He is also hopeful that it will result in more women choosing interventional cardiology: “Women are safe in the cath lab with current lead systems, but if we could move to this, there would be even more women participating.”
Pregnancy Safe in the Cath Lab
Dr. Sutton reiterated his point: “The number-one message that I want to get across is that it is considered safe for the unborn baby, being in the cath lab, under lead,” she said, noting that there are very good data that the amount of lead that is required by states results in negligible radiation exposure to the developing fetus.
She had her children before working in the cath lab, “but I’ve heard from other women: It’s heavy and its sweaty for prolonged periods of time, but it can be done and you can get through it,” she said. Although the promise of radiation protection systems “is exciting, we have to approach this with some level of caution or awareness,” she said. “Cardiologists come from a cardiology background. We are not radiologists who go through a radiology residency, like IRs do. They get a lot of training on radiation exposure and what it means,” Dr. Sutton stressed.
Dr. Kereiakes, for his part, remains enthusiastic. He returned to the cath lab in August, just 6 months after his brush with near quadriplegia. “This is what I’ve spent my life doing and I love doing it, and I’m not ready to quit.”
Dr. Hermiller, Dr. Kereiakes, and Dr. Sutton reported having no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
Species Possibly Responsible for COVID Pandemic Identified
The origin of the COVID-19 pandemic has sparked much debate, and various hypotheses have been put forward.
“My colleagues and I have examined the issue with an open mind, taking into account all possible hypotheses. The laboratory origin hypothesis was legitimate and deserved to be investigated,” Florence Débarre, PhD, a research director at the French National Center for Scientific Research at the Institute of Ecology and Environmental Sciences in Paris, France, told this news organization. Nevertheless,
“We studied data from environmental samples taken at the Huanan market in Wuhan shortly after its closure in early 2020,” said Dr. Débarre. The data were shared by the Chinese Center for Disease Control and Prevention on open and public databases. They include the raw genetic sequences of more than 800 samples collected at the Huanan market, on cages and carts, on the floors and walls of the stalls, and in the pipes and sewers.
These data allowed researchers to highlight the co-presence at this location of genetic material from the SARS-CoV-2 virus and certain wild animals. Masked palm civets, which are wild canids similar to foxes, with a dark facial mask similar to that of raccoons, and civets, small carnivorous mammals close to mongooses, were at the site.
“These species were already involved in the emergence of the SARS epidemic in the early 2000s and considered to facilitate the transmission of the virus from animals to humans,” said Dr. Débarre.
These animals were identified based on their DNA and located in the southwest part of the market, which is also a hotspot where many samples tested positive for SARS-CoV-2.
“There is a particular stall where the virus and the animals were found,” she said.
Since the data used are based on environmental samples, it is not possible to formally demonstrate that the animals were infected, but the discovery of virus samples located in the same place as the genetic material of these animals suggests that they were.
“There were samples taken from some animals at the market, but not from others, as they had already been evacuated when the sampling services arrived,” said Dr. Débarre. These results add to a large body of evidence that all points in the same direction: an animal origin at the Wuhan market.
The team also found other zoonotic viruses, such as avian flu. “This study confirms that live animal markets pose a high health risk, especially when they are at the heart of urban centers,” said Dr. Débarre. “It can provide avenues for prevention, particularly by limiting interactions between humans and wild fauna.”
This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
The origin of the COVID-19 pandemic has sparked much debate, and various hypotheses have been put forward.
“My colleagues and I have examined the issue with an open mind, taking into account all possible hypotheses. The laboratory origin hypothesis was legitimate and deserved to be investigated,” Florence Débarre, PhD, a research director at the French National Center for Scientific Research at the Institute of Ecology and Environmental Sciences in Paris, France, told this news organization. Nevertheless,
“We studied data from environmental samples taken at the Huanan market in Wuhan shortly after its closure in early 2020,” said Dr. Débarre. The data were shared by the Chinese Center for Disease Control and Prevention on open and public databases. They include the raw genetic sequences of more than 800 samples collected at the Huanan market, on cages and carts, on the floors and walls of the stalls, and in the pipes and sewers.
These data allowed researchers to highlight the co-presence at this location of genetic material from the SARS-CoV-2 virus and certain wild animals. Masked palm civets, which are wild canids similar to foxes, with a dark facial mask similar to that of raccoons, and civets, small carnivorous mammals close to mongooses, were at the site.
“These species were already involved in the emergence of the SARS epidemic in the early 2000s and considered to facilitate the transmission of the virus from animals to humans,” said Dr. Débarre.
These animals were identified based on their DNA and located in the southwest part of the market, which is also a hotspot where many samples tested positive for SARS-CoV-2.
“There is a particular stall where the virus and the animals were found,” she said.
Since the data used are based on environmental samples, it is not possible to formally demonstrate that the animals were infected, but the discovery of virus samples located in the same place as the genetic material of these animals suggests that they were.
“There were samples taken from some animals at the market, but not from others, as they had already been evacuated when the sampling services arrived,” said Dr. Débarre. These results add to a large body of evidence that all points in the same direction: an animal origin at the Wuhan market.
The team also found other zoonotic viruses, such as avian flu. “This study confirms that live animal markets pose a high health risk, especially when they are at the heart of urban centers,” said Dr. Débarre. “It can provide avenues for prevention, particularly by limiting interactions between humans and wild fauna.”
This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
The origin of the COVID-19 pandemic has sparked much debate, and various hypotheses have been put forward.
“My colleagues and I have examined the issue with an open mind, taking into account all possible hypotheses. The laboratory origin hypothesis was legitimate and deserved to be investigated,” Florence Débarre, PhD, a research director at the French National Center for Scientific Research at the Institute of Ecology and Environmental Sciences in Paris, France, told this news organization. Nevertheless,
“We studied data from environmental samples taken at the Huanan market in Wuhan shortly after its closure in early 2020,” said Dr. Débarre. The data were shared by the Chinese Center for Disease Control and Prevention on open and public databases. They include the raw genetic sequences of more than 800 samples collected at the Huanan market, on cages and carts, on the floors and walls of the stalls, and in the pipes and sewers.
These data allowed researchers to highlight the co-presence at this location of genetic material from the SARS-CoV-2 virus and certain wild animals. Masked palm civets, which are wild canids similar to foxes, with a dark facial mask similar to that of raccoons, and civets, small carnivorous mammals close to mongooses, were at the site.
“These species were already involved in the emergence of the SARS epidemic in the early 2000s and considered to facilitate the transmission of the virus from animals to humans,” said Dr. Débarre.
These animals were identified based on their DNA and located in the southwest part of the market, which is also a hotspot where many samples tested positive for SARS-CoV-2.
“There is a particular stall where the virus and the animals were found,” she said.
Since the data used are based on environmental samples, it is not possible to formally demonstrate that the animals were infected, but the discovery of virus samples located in the same place as the genetic material of these animals suggests that they were.
“There were samples taken from some animals at the market, but not from others, as they had already been evacuated when the sampling services arrived,” said Dr. Débarre. These results add to a large body of evidence that all points in the same direction: an animal origin at the Wuhan market.
The team also found other zoonotic viruses, such as avian flu. “This study confirms that live animal markets pose a high health risk, especially when they are at the heart of urban centers,” said Dr. Débarre. “It can provide avenues for prevention, particularly by limiting interactions between humans and wild fauna.”
This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Beyond the Title: How PAs Handle the Burden of MD-Level Responsibilities
Within the physician assistant (PA) community, many PAs have expressed the heavy weight of their job expectation and their subsequent feelings of discontent.
Mirela Bruza-Augatis, PhD, MS, PA-C, a researcher at the National Commission on Certification of Physician Assistants, said the sentiment is similar to what she’s heard from colleagues, as well as seen in her own research examining PA work-life balance.
“Unfortunately, part of this is just the culture of medicine — and other healthcare workers report similar experiences. The patient comes first, and you are secondary,” she said. “You have to make do with the resources you have, and that’s not always enough.”
Yet, despite the challenges of working as a PA in today’s healthcare industry, many are finding ways not just to survive but to thrive. Brian McCambley, DHSc, PA-C, who works as both an emergency medicine PA and a system wellness officer at Nuvance Health, has been looking at ways to improve morale (and, consequently, lower turnover rates), especially among new PA recruits.
He said that the first step is finding the right practice environment. He encourages even experienced PAs to take the time to understand the culture of any practice they consider joining — and ask a lot of questions about what kind of support is available.
“Ask the right questions from the very beginning. What does the job truly entail? What is the culture within the group that you’ll be joining? Talk to the entire team to get a real sense of what’s going on there day to day,” he said. “One benefit of being a PA is that most of us are trained as generalists. We have a lot of mobility between specialties. If the work hours, culture, or fit doesn’t work, it is possible to morph and try something different.”
See How Other PAs Are Managing
Dr. Bruza-Augatis added that finding peer support is also beneficial. She said being able to discuss your experiences with other PAs, both within your workplace and outside of it, offers more than just the benefit of knowing you are not alone.
“When you talk to other colleagues who have had similar experiences, they may have found solutions to help,” she said. “The solution that works for one person may not work for everyone. But it can at least offer some ideas and help you focus on the things you may be able to control and change.”
Raquelle Akavan, DMSc, PA-C, founder of the popular PA Moms® group, agreed on both points. She said that finding both institutional and personal support is remarkably helpful in dealing with the stressors most PAs face both at work and home. With that kind of support in place, you can start to set the appropriate boundaries to help ensure you aren’t feeling overwhelmed by all the expectations placed on you.
“This is crucial to finding good work-life integration,” she said. “You can set boundaries with both your patients and your managers. You can carve out time for your family and let your job know that you won’t be taking calls between 5:00 pm and 9:00 pm. You can go to your manager and let them know what you need to do your job well — whether it’s a scribe, continuing medical education, or help managing the workload.”
Speak Up
Advocating for yourself is key, said Hope Cook, PA-C, who works as both a PA in a dermatology practice and as a licensed life coach. She said that taking the time to be self-aware of the work stressors that negatively affect you allows you to “give yourself permission” to do something about them.
“Like any profession, you have to know your limits,” she said. “If you need more collaboration from your team, you need to figure out how to get that. You need to ask for it. If you feel like you have insufficient training to deal with the complexity of the patients who are coming to see you, you need to talk to the practice about how to fix that. It’s important to let people know what support you need. And, if they aren’t going to help provide it, understand that it may be time to go elsewhere.”
None of these things are necessarily easy, said Dr. McCambley. But replacing a PA costs a practice significant time and money. So, finding ways to promote growth and resilience early on in your career will help protect you from later burnout, and save the healthcare organization in the long run, too. He believes Nuvance has had great success in their efforts to support clinician wellness across the board by having PAs contribute to leadership discussions and decisions.
“When you can get with like-minded folks and sit with hospital administration to talk about the best ways to get PAs intermixed with the medical staff and how to support them in their roles, you can make a difference,” he told this news organization. “I’ve been at my healthcare institution for 26 years. We PAs didn’t really have a big voice at the beginning. But, little by little, by having important discussions with our leadership, we’ve been able to show our medical staff that PAs bring something really important to the table — and that it benefits everyone when we support them.”
A version of this article first appeared on Medscape.com.
Within the physician assistant (PA) community, many PAs have expressed the heavy weight of their job expectation and their subsequent feelings of discontent.
Mirela Bruza-Augatis, PhD, MS, PA-C, a researcher at the National Commission on Certification of Physician Assistants, said the sentiment is similar to what she’s heard from colleagues, as well as seen in her own research examining PA work-life balance.
“Unfortunately, part of this is just the culture of medicine — and other healthcare workers report similar experiences. The patient comes first, and you are secondary,” she said. “You have to make do with the resources you have, and that’s not always enough.”
Yet, despite the challenges of working as a PA in today’s healthcare industry, many are finding ways not just to survive but to thrive. Brian McCambley, DHSc, PA-C, who works as both an emergency medicine PA and a system wellness officer at Nuvance Health, has been looking at ways to improve morale (and, consequently, lower turnover rates), especially among new PA recruits.
He said that the first step is finding the right practice environment. He encourages even experienced PAs to take the time to understand the culture of any practice they consider joining — and ask a lot of questions about what kind of support is available.
“Ask the right questions from the very beginning. What does the job truly entail? What is the culture within the group that you’ll be joining? Talk to the entire team to get a real sense of what’s going on there day to day,” he said. “One benefit of being a PA is that most of us are trained as generalists. We have a lot of mobility between specialties. If the work hours, culture, or fit doesn’t work, it is possible to morph and try something different.”
See How Other PAs Are Managing
Dr. Bruza-Augatis added that finding peer support is also beneficial. She said being able to discuss your experiences with other PAs, both within your workplace and outside of it, offers more than just the benefit of knowing you are not alone.
“When you talk to other colleagues who have had similar experiences, they may have found solutions to help,” she said. “The solution that works for one person may not work for everyone. But it can at least offer some ideas and help you focus on the things you may be able to control and change.”
Raquelle Akavan, DMSc, PA-C, founder of the popular PA Moms® group, agreed on both points. She said that finding both institutional and personal support is remarkably helpful in dealing with the stressors most PAs face both at work and home. With that kind of support in place, you can start to set the appropriate boundaries to help ensure you aren’t feeling overwhelmed by all the expectations placed on you.
“This is crucial to finding good work-life integration,” she said. “You can set boundaries with both your patients and your managers. You can carve out time for your family and let your job know that you won’t be taking calls between 5:00 pm and 9:00 pm. You can go to your manager and let them know what you need to do your job well — whether it’s a scribe, continuing medical education, or help managing the workload.”
Speak Up
Advocating for yourself is key, said Hope Cook, PA-C, who works as both a PA in a dermatology practice and as a licensed life coach. She said that taking the time to be self-aware of the work stressors that negatively affect you allows you to “give yourself permission” to do something about them.
“Like any profession, you have to know your limits,” she said. “If you need more collaboration from your team, you need to figure out how to get that. You need to ask for it. If you feel like you have insufficient training to deal with the complexity of the patients who are coming to see you, you need to talk to the practice about how to fix that. It’s important to let people know what support you need. And, if they aren’t going to help provide it, understand that it may be time to go elsewhere.”
None of these things are necessarily easy, said Dr. McCambley. But replacing a PA costs a practice significant time and money. So, finding ways to promote growth and resilience early on in your career will help protect you from later burnout, and save the healthcare organization in the long run, too. He believes Nuvance has had great success in their efforts to support clinician wellness across the board by having PAs contribute to leadership discussions and decisions.
“When you can get with like-minded folks and sit with hospital administration to talk about the best ways to get PAs intermixed with the medical staff and how to support them in their roles, you can make a difference,” he told this news organization. “I’ve been at my healthcare institution for 26 years. We PAs didn’t really have a big voice at the beginning. But, little by little, by having important discussions with our leadership, we’ve been able to show our medical staff that PAs bring something really important to the table — and that it benefits everyone when we support them.”
A version of this article first appeared on Medscape.com.
Within the physician assistant (PA) community, many PAs have expressed the heavy weight of their job expectation and their subsequent feelings of discontent.
Mirela Bruza-Augatis, PhD, MS, PA-C, a researcher at the National Commission on Certification of Physician Assistants, said the sentiment is similar to what she’s heard from colleagues, as well as seen in her own research examining PA work-life balance.
“Unfortunately, part of this is just the culture of medicine — and other healthcare workers report similar experiences. The patient comes first, and you are secondary,” she said. “You have to make do with the resources you have, and that’s not always enough.”
Yet, despite the challenges of working as a PA in today’s healthcare industry, many are finding ways not just to survive but to thrive. Brian McCambley, DHSc, PA-C, who works as both an emergency medicine PA and a system wellness officer at Nuvance Health, has been looking at ways to improve morale (and, consequently, lower turnover rates), especially among new PA recruits.
He said that the first step is finding the right practice environment. He encourages even experienced PAs to take the time to understand the culture of any practice they consider joining — and ask a lot of questions about what kind of support is available.
“Ask the right questions from the very beginning. What does the job truly entail? What is the culture within the group that you’ll be joining? Talk to the entire team to get a real sense of what’s going on there day to day,” he said. “One benefit of being a PA is that most of us are trained as generalists. We have a lot of mobility between specialties. If the work hours, culture, or fit doesn’t work, it is possible to morph and try something different.”
See How Other PAs Are Managing
Dr. Bruza-Augatis added that finding peer support is also beneficial. She said being able to discuss your experiences with other PAs, both within your workplace and outside of it, offers more than just the benefit of knowing you are not alone.
“When you talk to other colleagues who have had similar experiences, they may have found solutions to help,” she said. “The solution that works for one person may not work for everyone. But it can at least offer some ideas and help you focus on the things you may be able to control and change.”
Raquelle Akavan, DMSc, PA-C, founder of the popular PA Moms® group, agreed on both points. She said that finding both institutional and personal support is remarkably helpful in dealing with the stressors most PAs face both at work and home. With that kind of support in place, you can start to set the appropriate boundaries to help ensure you aren’t feeling overwhelmed by all the expectations placed on you.
“This is crucial to finding good work-life integration,” she said. “You can set boundaries with both your patients and your managers. You can carve out time for your family and let your job know that you won’t be taking calls between 5:00 pm and 9:00 pm. You can go to your manager and let them know what you need to do your job well — whether it’s a scribe, continuing medical education, or help managing the workload.”
Speak Up
Advocating for yourself is key, said Hope Cook, PA-C, who works as both a PA in a dermatology practice and as a licensed life coach. She said that taking the time to be self-aware of the work stressors that negatively affect you allows you to “give yourself permission” to do something about them.
“Like any profession, you have to know your limits,” she said. “If you need more collaboration from your team, you need to figure out how to get that. You need to ask for it. If you feel like you have insufficient training to deal with the complexity of the patients who are coming to see you, you need to talk to the practice about how to fix that. It’s important to let people know what support you need. And, if they aren’t going to help provide it, understand that it may be time to go elsewhere.”
None of these things are necessarily easy, said Dr. McCambley. But replacing a PA costs a practice significant time and money. So, finding ways to promote growth and resilience early on in your career will help protect you from later burnout, and save the healthcare organization in the long run, too. He believes Nuvance has had great success in their efforts to support clinician wellness across the board by having PAs contribute to leadership discussions and decisions.
“When you can get with like-minded folks and sit with hospital administration to talk about the best ways to get PAs intermixed with the medical staff and how to support them in their roles, you can make a difference,” he told this news organization. “I’ve been at my healthcare institution for 26 years. We PAs didn’t really have a big voice at the beginning. But, little by little, by having important discussions with our leadership, we’ve been able to show our medical staff that PAs bring something really important to the table — and that it benefits everyone when we support them.”
A version of this article first appeared on Medscape.com.
Nearly 1 in 3 US Adults May Have Low Iron Levels
Nearly one-third of US adults may have low iron levels that can add to problems ranging from fatigue to heart failure.
Researchers in a new study estimated that 7% of US adults have anemia, a blood disorder that can be iron related and is particularly well-known in part because of screenings given during pregnancy. But more striking was the finding in this latest study that a significant portion of the population may have less severe iron deficiencies that have been linked to serious health problems.
The body gets iron from food, and it can store iron for times when there isn’t enough it can access right away. The research team looked at test results that show whether people have enough iron stored, as well as whether their bodies could effectively use available iron. If you don’t have enough iron stored, you have a condition called absolute iron deficiency. And if you have stored iron but problems using it, you have what’s called functional iron deficiency. The study found that an estimated 14% of adults have absolute iron deficiency, and another 15% have functional iron deficiency.
The findings, published in JAMA Network Open, are based on data from more than 8,000 people who had laboratory iron levels on file as part of the National Health and Nutrition Examination Survey that was done from 2017 to 2020.
Besides anemia, iron deficiency is linked to other serious health problems, including restless legs syndrome, mental and thinking difficulties, reduced physical abilities, and heart failure, the authors noted. The effects of iron deficiency can significantly impact a person’s quality of life.
Routine blood work as part of an annual physical doesn’t typically include a check of iron levels unless there is a cause for concern. The out-of-pocket cost without using insurance for a blood test to check iron levels is typically around $60.
“This is a common yet underappreciated public health problem,” study author Leo Buckley, PharmD, MPH, a clinical pharmacology specialist at Brigham and Women’s Hospital in Boston, Massachusetts, told NBC News. “What’s unique about our study is we were looking at regular people who would not otherwise have been screened or tested.”
Treatment for low iron levels can include changes to your diet, as well as intravenous or oral supplements. Taking an iron supplement should be done under the guidance of a health care provider because of the risk of iron toxicity.
A version of this article first appeared on WebMD.com.
Nearly one-third of US adults may have low iron levels that can add to problems ranging from fatigue to heart failure.
Researchers in a new study estimated that 7% of US adults have anemia, a blood disorder that can be iron related and is particularly well-known in part because of screenings given during pregnancy. But more striking was the finding in this latest study that a significant portion of the population may have less severe iron deficiencies that have been linked to serious health problems.
The body gets iron from food, and it can store iron for times when there isn’t enough it can access right away. The research team looked at test results that show whether people have enough iron stored, as well as whether their bodies could effectively use available iron. If you don’t have enough iron stored, you have a condition called absolute iron deficiency. And if you have stored iron but problems using it, you have what’s called functional iron deficiency. The study found that an estimated 14% of adults have absolute iron deficiency, and another 15% have functional iron deficiency.
The findings, published in JAMA Network Open, are based on data from more than 8,000 people who had laboratory iron levels on file as part of the National Health and Nutrition Examination Survey that was done from 2017 to 2020.
Besides anemia, iron deficiency is linked to other serious health problems, including restless legs syndrome, mental and thinking difficulties, reduced physical abilities, and heart failure, the authors noted. The effects of iron deficiency can significantly impact a person’s quality of life.
Routine blood work as part of an annual physical doesn’t typically include a check of iron levels unless there is a cause for concern. The out-of-pocket cost without using insurance for a blood test to check iron levels is typically around $60.
“This is a common yet underappreciated public health problem,” study author Leo Buckley, PharmD, MPH, a clinical pharmacology specialist at Brigham and Women’s Hospital in Boston, Massachusetts, told NBC News. “What’s unique about our study is we were looking at regular people who would not otherwise have been screened or tested.”
Treatment for low iron levels can include changes to your diet, as well as intravenous or oral supplements. Taking an iron supplement should be done under the guidance of a health care provider because of the risk of iron toxicity.
A version of this article first appeared on WebMD.com.
Nearly one-third of US adults may have low iron levels that can add to problems ranging from fatigue to heart failure.
Researchers in a new study estimated that 7% of US adults have anemia, a blood disorder that can be iron related and is particularly well-known in part because of screenings given during pregnancy. But more striking was the finding in this latest study that a significant portion of the population may have less severe iron deficiencies that have been linked to serious health problems.
The body gets iron from food, and it can store iron for times when there isn’t enough it can access right away. The research team looked at test results that show whether people have enough iron stored, as well as whether their bodies could effectively use available iron. If you don’t have enough iron stored, you have a condition called absolute iron deficiency. And if you have stored iron but problems using it, you have what’s called functional iron deficiency. The study found that an estimated 14% of adults have absolute iron deficiency, and another 15% have functional iron deficiency.
The findings, published in JAMA Network Open, are based on data from more than 8,000 people who had laboratory iron levels on file as part of the National Health and Nutrition Examination Survey that was done from 2017 to 2020.
Besides anemia, iron deficiency is linked to other serious health problems, including restless legs syndrome, mental and thinking difficulties, reduced physical abilities, and heart failure, the authors noted. The effects of iron deficiency can significantly impact a person’s quality of life.
Routine blood work as part of an annual physical doesn’t typically include a check of iron levels unless there is a cause for concern. The out-of-pocket cost without using insurance for a blood test to check iron levels is typically around $60.
“This is a common yet underappreciated public health problem,” study author Leo Buckley, PharmD, MPH, a clinical pharmacology specialist at Brigham and Women’s Hospital in Boston, Massachusetts, told NBC News. “What’s unique about our study is we were looking at regular people who would not otherwise have been screened or tested.”
Treatment for low iron levels can include changes to your diet, as well as intravenous or oral supplements. Taking an iron supplement should be done under the guidance of a health care provider because of the risk of iron toxicity.
A version of this article first appeared on WebMD.com.
FROM JAMA NETWORK OPEN
Walking App Works Only if Users Think It Does
TOPLINE:
Apps designed to increase physical activity may be useful in increasing daily step counts for users who believe the intervention beneficial, but not for those who do not. The app’s effectiveness is notably influenced by how users perceive its utility.
METHODOLOGY:
- Researchers conducted a randomized controlled trial from February 2021 to May 2022 to evaluate the effectiveness of SNapp, an adaptive app designed to promote walking through tailored coaching content.
- Overall, 176 adults (76% women; mean age, 56 years) were randomly assigned to use the app plus tailored coaching content (SNapp group; n = 87) or only the step counter app (control group; n = 89).
- SNapp’s coaching content provided personalized feedback on step counts and recommendations for increasing walking, while also considering individual preferences for behavior change techniques.
- The primary outcome was the daily step count recorded by the app, which was updated on an hourly basis in a database over an intervention period of 12 months.
- Perceptions of ease of use and usefulness were assessed to determine their effect on the effectiveness of the app.
TAKEAWAY:
- Intervention group participants used the app nearly 30% of days, while those using the app alone showed almost identical use.
- The SNapp intervention did not significantly affect the step counts on average over time (B, −202.30; 95% CI, −889.7 to 485.1).
- Perceived usefulness significantly moderated the intervention effect of SNapp (B, 344.38; 90% CI, 40.4-648.3), but perceived ease of use did not (B, 38.60; 90% CI, −276.5 to 353.7).
- Among participants with a high perceived usefulness, the SNapp group had a higher median step count than the control group (median difference, 1260 steps; 90% CI, −3243.7 to 1298.2); however, this difference was not statistically significant.
IN PRACTICE:
“This study shows that perceived usefulness is also an important factor influencing behavioral effects. Hence, it is essential for apps to be perceived as useful to effectively improve users’ activity levels,” the authors wrote.
SOURCE:
The study was led by Anne L. Vos, PhD, of the Amsterdam School of Communication Research at the University of Amsterdam, in the Netherlands. It was published online on September 16, 2024, in the American Journal of Preventive Medicine.
LIMITATIONS:
The study’s recruitment strategy primarily attracted highly educated individuals, limiting generalizability. The app’s accuracy in measuring steps could be improved, as it sometimes underestimated step counts. Researchers also were unable to check if participants read messages from coaches.
DISCLOSURES:
The study was supported by grants from the Dutch Heart Foundation and the Netherlands Organisation for Health Research and Development. No relevant conflicts of interest were disclosed by the authors.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Apps designed to increase physical activity may be useful in increasing daily step counts for users who believe the intervention beneficial, but not for those who do not. The app’s effectiveness is notably influenced by how users perceive its utility.
METHODOLOGY:
- Researchers conducted a randomized controlled trial from February 2021 to May 2022 to evaluate the effectiveness of SNapp, an adaptive app designed to promote walking through tailored coaching content.
- Overall, 176 adults (76% women; mean age, 56 years) were randomly assigned to use the app plus tailored coaching content (SNapp group; n = 87) or only the step counter app (control group; n = 89).
- SNapp’s coaching content provided personalized feedback on step counts and recommendations for increasing walking, while also considering individual preferences for behavior change techniques.
- The primary outcome was the daily step count recorded by the app, which was updated on an hourly basis in a database over an intervention period of 12 months.
- Perceptions of ease of use and usefulness were assessed to determine their effect on the effectiveness of the app.
TAKEAWAY:
- Intervention group participants used the app nearly 30% of days, while those using the app alone showed almost identical use.
- The SNapp intervention did not significantly affect the step counts on average over time (B, −202.30; 95% CI, −889.7 to 485.1).
- Perceived usefulness significantly moderated the intervention effect of SNapp (B, 344.38; 90% CI, 40.4-648.3), but perceived ease of use did not (B, 38.60; 90% CI, −276.5 to 353.7).
- Among participants with a high perceived usefulness, the SNapp group had a higher median step count than the control group (median difference, 1260 steps; 90% CI, −3243.7 to 1298.2); however, this difference was not statistically significant.
IN PRACTICE:
“This study shows that perceived usefulness is also an important factor influencing behavioral effects. Hence, it is essential for apps to be perceived as useful to effectively improve users’ activity levels,” the authors wrote.
SOURCE:
The study was led by Anne L. Vos, PhD, of the Amsterdam School of Communication Research at the University of Amsterdam, in the Netherlands. It was published online on September 16, 2024, in the American Journal of Preventive Medicine.
LIMITATIONS:
The study’s recruitment strategy primarily attracted highly educated individuals, limiting generalizability. The app’s accuracy in measuring steps could be improved, as it sometimes underestimated step counts. Researchers also were unable to check if participants read messages from coaches.
DISCLOSURES:
The study was supported by grants from the Dutch Heart Foundation and the Netherlands Organisation for Health Research and Development. No relevant conflicts of interest were disclosed by the authors.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Apps designed to increase physical activity may be useful in increasing daily step counts for users who believe the intervention beneficial, but not for those who do not. The app’s effectiveness is notably influenced by how users perceive its utility.
METHODOLOGY:
- Researchers conducted a randomized controlled trial from February 2021 to May 2022 to evaluate the effectiveness of SNapp, an adaptive app designed to promote walking through tailored coaching content.
- Overall, 176 adults (76% women; mean age, 56 years) were randomly assigned to use the app plus tailored coaching content (SNapp group; n = 87) or only the step counter app (control group; n = 89).
- SNapp’s coaching content provided personalized feedback on step counts and recommendations for increasing walking, while also considering individual preferences for behavior change techniques.
- The primary outcome was the daily step count recorded by the app, which was updated on an hourly basis in a database over an intervention period of 12 months.
- Perceptions of ease of use and usefulness were assessed to determine their effect on the effectiveness of the app.
TAKEAWAY:
- Intervention group participants used the app nearly 30% of days, while those using the app alone showed almost identical use.
- The SNapp intervention did not significantly affect the step counts on average over time (B, −202.30; 95% CI, −889.7 to 485.1).
- Perceived usefulness significantly moderated the intervention effect of SNapp (B, 344.38; 90% CI, 40.4-648.3), but perceived ease of use did not (B, 38.60; 90% CI, −276.5 to 353.7).
- Among participants with a high perceived usefulness, the SNapp group had a higher median step count than the control group (median difference, 1260 steps; 90% CI, −3243.7 to 1298.2); however, this difference was not statistically significant.
IN PRACTICE:
“This study shows that perceived usefulness is also an important factor influencing behavioral effects. Hence, it is essential for apps to be perceived as useful to effectively improve users’ activity levels,” the authors wrote.
SOURCE:
The study was led by Anne L. Vos, PhD, of the Amsterdam School of Communication Research at the University of Amsterdam, in the Netherlands. It was published online on September 16, 2024, in the American Journal of Preventive Medicine.
LIMITATIONS:
The study’s recruitment strategy primarily attracted highly educated individuals, limiting generalizability. The app’s accuracy in measuring steps could be improved, as it sometimes underestimated step counts. Researchers also were unable to check if participants read messages from coaches.
DISCLOSURES:
The study was supported by grants from the Dutch Heart Foundation and the Netherlands Organisation for Health Research and Development. No relevant conflicts of interest were disclosed by the authors.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
‘Call to Action’: Greater CVD Focus Urged for Type 1 Diabetes
MADRID — Emerging data points to the urgent need for cardiovascular risk reduction in all adults with type 1 diabetes (T1D), including those who are young and those diagnosed in adulthood.
At the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting, two entire oral abstract sessions were devoted to research examining cardiovascular risk specifically in people with T1D. There is increasing evidence that as with type 2 diabetes (T2D), clinical visits need to focus on other cardiovascular risk factors and glucose.
Findings included the evidence of severe coronary artery disease (CAD) in asymptomatic adults with T1D, increased risks for mortality and cardiac events in people diagnosed with T1D in adulthood, and a greater cardiovascular risk for those with overweight/obesity and among those with more cumulative exposure to both hyperglycemia and dyslipidemia.
One speaker, Dr. Rebecka Johanna Bergdal, of the Folkhälsan Research Center and the University of Helsinki, Finland, issued a “call to action,” saying, “We call on healthcare professionals to continue supporting and encouraging individuals with T1D towards better management of diabetes, including both glucose and lipid management.”
Session Moderator Krzysztof Strojek, MD, PhD, head of the Department of Internal Medicine, Diabetology and Cardiometabolic Diseases at the Medical University of Silesia, Katowice, Poland, told this news organization that all the data point in the same direction for T1D management, to “look not only at A1c and blood glucose control but also lipids, hypertension, smoking status, all these risk factors recognized in type 2 ... are also important in T1D.”
The ‘Alarming’ Finding of CAD in Asymptomatic Patients
Michal Dubsky, MD, PhD, of the Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic, presented findings from 62 asymptomatic patients with T1D for > 10 years (mean, 36 years), with a mean A1c of 7.5% (58 mmol/mol), and no prior history of cardiovascular disease (CVD). They had slightly elevated CVD biomarkers, including a mean low-density lipoprotein (LDL) cholesterol level of 2.33 mmol/L, lipoprotein (a) level of 15 nmol/L, and N-terminal pro-B-type natriuretic peptide level of 125.3 ng/L.
All underwent a noninvasive carotid ultrasound and coronary artery calcium (CAC) scoring. Of those, 12 patients had a CAC score > 400 and/or presence of two or more carotid plaques identified as high-risk.
Those 12 patients underwent coronary angiography and had a total of 29 vessels examined by optical coherence tomography (OCT), “an invasive intravascular method for assessing coronary atherosclerosis that is far more sensitive than standard coronary angiography, especially for the detection of high-risk vulnerable plaques without a hemodynamically significant stenosis,” Dr. Dubsky explained.
Coronary angiography showed obstructive CAD in 5 of the 12 patients. Their mean calcium score was 950 and mean number of carotid plaques was 2.8. Features associated with plaque vulnerability included microphage accumulation in 24 vessels, lipid-rich plaques in 23, spotty calcium in 19, and neovascularizations in 13.
Thin-cap fibroatheroma, a strong predictor of plaque rupture, was present in 7 of the 12 patients (58.3%), and four had features of very high-risk plaques, defined as thin-cap fibroatheroma with a minimal lumen area < 3.5 mm2, a lipid arch > 180 degrees, and macrophages.
“Our study showed that asymptomatic T1D patients with high CAC score and carotid plaques had very severe OCT findings. We observed a significant proportion of high-risk lesions potentially associated with plaque rupture and risk of CV death. Therefore, we believe these patients should be treated as very high-risk with target LDL below 1.4 mmol/L (55 mg/dL), even though they are completely asymptomatic,” Dr. Dubsky concluded.
He added that because OCT is invasive and costly, the CAC score can be used to guide the decision for statin use, with any score above 100 considered elevated risk.
Study coauthor Martin Haluzik, MD, professor of internal medicine in the Charles University, Prague, Czech Republic, told this news organization, “I think it’s very alarming because some of these are basically very healthy-looking young people, so you don’t really expect them to have significant cardiovascular complications already or significant plaques. I think it shows that we should be more proactive in looking into the risk of cardiovascular complications and in looking into the early cardiovascular changes.”
Later Diagnosis Doesn’t Always Protect: Risk Seen in Adult-Onset T1D
Yuxia Wei, a PhD student at the Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden, presented an analysis of data from Sweden’s national health databases comparing cardiovascular outcomes between 10,184 people diagnosed with T1D at ages 18-29 years, 30-39 years, and ≥ 40 years; another 375,523 people diagnosed with T2D at those ages; and 509,172 population controls matched for age, sex, and county.
Those diagnosed after age 40 years had higher A1c levels and were less likely to be using insulin pumps than those diagnosed at younger adult ages.
Compared with population controls, at a median of about 7 years of follow-up, people with T1D had significantly higher all-cause mortality at all diagnosis age groups, with a hazard ratio of 1.71. This rose to 2.78 for those diagnosed at age 30-39 years.
Compared with those with T2D, the mortality risks weren’t significantly different at any age, but the risks for non-cardiovascular death, including from cancer and infection, were significantly higher among those diagnosed after age 40 years (1.31 overall). Those diagnosed with T1D at any adult age had lower risks for major cardiovascular events than those diagnosed with T2D. Hazard ratios ranged from 0.27 for those diagnosed at age 18-29 years to 0.78 for those diagnosed after the age of 40 years.
Smoking and A1c above target were the greatest contributors to mortality. Those two factors, along with body mass index (BMI), were the strongest contributors to major adverse cardiovascular events (MACE).
“Adult-onset T1D carries excess risk of death and cardiovascular disease, without obvious attenuation over age at diagnosis…Smoking, A1c, and BMI are the key factors to be managed to improve prognosis in adult-onset T1D,” Ms. Wei concluded.
BMI: Often Overlooked in T1D, but a Major CVD Risk Factor
Two studies examined the link between overweight/obesity and cardiovascular risk in T1D. One, by Laurence Salle, MCU PH, of the Endocrinology, Diabetes and Metabolic Diseases Department at CHU Limoges, France, was a prospective, longitudinal cohort study of 2367 people with T1D at 68 centers in France who didn’t have a cardiovascular history at baseline.
Of those, 51% had normal BMI (18.5-24.9), 31% had overweight (25-29.9), and 18% had obesity (≥ 30). Cardiovascular risk factors, including LDL cholesterol, triglycerides, and hypertension increased with an increasing BMI. The 10-year CVD risk was significantly higher for those with overweight (9.61%) and obesity (9.93%) than for those with normal weight (7.24%), in both men and women.
However, BMI was found to be an independent predictor of 10-year high cardiovascular risk in men but not women, while waist:height ratio independently predicted risk in both men and women, Dr. Salle reported.
The second BMI study, from Enrique Soto-Pedre, MBBS, of the Division of Population Health and Genomics at the University of Dundee, Scotland, presented data on a retrospective follow-up from 1995 to 2019 of 1973 people with T1D aged > 18 years at diagnosis (42% women; mean age, 34.2 years; 18.9% had obesity.
After 10 years of follow-up, those with overweight and obesity had significantly higher odds of developing arterial hypertension, even among those taking angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, with statistically significant adjusted hazard ratios of 1.73 and 3.37 for the obese and overweight groups, respectively.
MACE were significantly more common among those with obesity, with an adjusted hazard ratio of 2.95, as was acute myocardial infarction, 3.33.
“These results emphasize the importance of incorporating weight management into the overall management of individuals with T1D. No one has doubts about weight management in T2D, but in type 1, it’s not so clear. One of the main [concerns] would be safety [in terms of hypoglycemia],” Dr. Soto-Pedre concluded.
Call for Action: Cumulative Glucose and Lipid Exposures Increase Risk
Dr. Bergdal presented data on the effects of cumulative glycemia and lipids on the risk for CAD in 3495 adults with T1D who had been diagnosed prior to the age of 40 years. The history of CAD or stroke was exclusion criteria. There were a total of 534 CAD events within a median follow-up of 19.4 years.
Cumulative glycemia, LDL cholesterol, triglycerides, and non–high-density lipoprotein cholesterol exposures were all significantly associated with CAD risk (P < .001 for all). With an adjustment for confounders, the highest tertile of glycemia was associated with a twofold increased risk for CAD. Both hyperglycemia and dyslipidemia were independently associated with CAD risk, Dr. Bergdal reported.
“It’s important to minimize the time spent above A1c 7%, and lipid management in T1D must not be forgotten,” she said, prior to issuing her call for action.
Dr. Haluzik reported receiving honoraria for talks and/or consultancy and/or research funding from Eli Lilly, Novo Nordisk, Sanofi, AstraZeneca, Mundipharma, Bristol Myers Squibb, Amgen, Boehringer Ingelheim, Janssen, Ypsomed, and Johnson & Johnson. The presenters had no disclosures.
A version of this article first appeared on Medscape.com.
MADRID — Emerging data points to the urgent need for cardiovascular risk reduction in all adults with type 1 diabetes (T1D), including those who are young and those diagnosed in adulthood.
At the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting, two entire oral abstract sessions were devoted to research examining cardiovascular risk specifically in people with T1D. There is increasing evidence that as with type 2 diabetes (T2D), clinical visits need to focus on other cardiovascular risk factors and glucose.
Findings included the evidence of severe coronary artery disease (CAD) in asymptomatic adults with T1D, increased risks for mortality and cardiac events in people diagnosed with T1D in adulthood, and a greater cardiovascular risk for those with overweight/obesity and among those with more cumulative exposure to both hyperglycemia and dyslipidemia.
One speaker, Dr. Rebecka Johanna Bergdal, of the Folkhälsan Research Center and the University of Helsinki, Finland, issued a “call to action,” saying, “We call on healthcare professionals to continue supporting and encouraging individuals with T1D towards better management of diabetes, including both glucose and lipid management.”
Session Moderator Krzysztof Strojek, MD, PhD, head of the Department of Internal Medicine, Diabetology and Cardiometabolic Diseases at the Medical University of Silesia, Katowice, Poland, told this news organization that all the data point in the same direction for T1D management, to “look not only at A1c and blood glucose control but also lipids, hypertension, smoking status, all these risk factors recognized in type 2 ... are also important in T1D.”
The ‘Alarming’ Finding of CAD in Asymptomatic Patients
Michal Dubsky, MD, PhD, of the Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic, presented findings from 62 asymptomatic patients with T1D for > 10 years (mean, 36 years), with a mean A1c of 7.5% (58 mmol/mol), and no prior history of cardiovascular disease (CVD). They had slightly elevated CVD biomarkers, including a mean low-density lipoprotein (LDL) cholesterol level of 2.33 mmol/L, lipoprotein (a) level of 15 nmol/L, and N-terminal pro-B-type natriuretic peptide level of 125.3 ng/L.
All underwent a noninvasive carotid ultrasound and coronary artery calcium (CAC) scoring. Of those, 12 patients had a CAC score > 400 and/or presence of two or more carotid plaques identified as high-risk.
Those 12 patients underwent coronary angiography and had a total of 29 vessels examined by optical coherence tomography (OCT), “an invasive intravascular method for assessing coronary atherosclerosis that is far more sensitive than standard coronary angiography, especially for the detection of high-risk vulnerable plaques without a hemodynamically significant stenosis,” Dr. Dubsky explained.
Coronary angiography showed obstructive CAD in 5 of the 12 patients. Their mean calcium score was 950 and mean number of carotid plaques was 2.8. Features associated with plaque vulnerability included microphage accumulation in 24 vessels, lipid-rich plaques in 23, spotty calcium in 19, and neovascularizations in 13.
Thin-cap fibroatheroma, a strong predictor of plaque rupture, was present in 7 of the 12 patients (58.3%), and four had features of very high-risk plaques, defined as thin-cap fibroatheroma with a minimal lumen area < 3.5 mm2, a lipid arch > 180 degrees, and macrophages.
“Our study showed that asymptomatic T1D patients with high CAC score and carotid plaques had very severe OCT findings. We observed a significant proportion of high-risk lesions potentially associated with plaque rupture and risk of CV death. Therefore, we believe these patients should be treated as very high-risk with target LDL below 1.4 mmol/L (55 mg/dL), even though they are completely asymptomatic,” Dr. Dubsky concluded.
He added that because OCT is invasive and costly, the CAC score can be used to guide the decision for statin use, with any score above 100 considered elevated risk.
Study coauthor Martin Haluzik, MD, professor of internal medicine in the Charles University, Prague, Czech Republic, told this news organization, “I think it’s very alarming because some of these are basically very healthy-looking young people, so you don’t really expect them to have significant cardiovascular complications already or significant plaques. I think it shows that we should be more proactive in looking into the risk of cardiovascular complications and in looking into the early cardiovascular changes.”
Later Diagnosis Doesn’t Always Protect: Risk Seen in Adult-Onset T1D
Yuxia Wei, a PhD student at the Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden, presented an analysis of data from Sweden’s national health databases comparing cardiovascular outcomes between 10,184 people diagnosed with T1D at ages 18-29 years, 30-39 years, and ≥ 40 years; another 375,523 people diagnosed with T2D at those ages; and 509,172 population controls matched for age, sex, and county.
Those diagnosed after age 40 years had higher A1c levels and were less likely to be using insulin pumps than those diagnosed at younger adult ages.
Compared with population controls, at a median of about 7 years of follow-up, people with T1D had significantly higher all-cause mortality at all diagnosis age groups, with a hazard ratio of 1.71. This rose to 2.78 for those diagnosed at age 30-39 years.
Compared with those with T2D, the mortality risks weren’t significantly different at any age, but the risks for non-cardiovascular death, including from cancer and infection, were significantly higher among those diagnosed after age 40 years (1.31 overall). Those diagnosed with T1D at any adult age had lower risks for major cardiovascular events than those diagnosed with T2D. Hazard ratios ranged from 0.27 for those diagnosed at age 18-29 years to 0.78 for those diagnosed after the age of 40 years.
Smoking and A1c above target were the greatest contributors to mortality. Those two factors, along with body mass index (BMI), were the strongest contributors to major adverse cardiovascular events (MACE).
“Adult-onset T1D carries excess risk of death and cardiovascular disease, without obvious attenuation over age at diagnosis…Smoking, A1c, and BMI are the key factors to be managed to improve prognosis in adult-onset T1D,” Ms. Wei concluded.
BMI: Often Overlooked in T1D, but a Major CVD Risk Factor
Two studies examined the link between overweight/obesity and cardiovascular risk in T1D. One, by Laurence Salle, MCU PH, of the Endocrinology, Diabetes and Metabolic Diseases Department at CHU Limoges, France, was a prospective, longitudinal cohort study of 2367 people with T1D at 68 centers in France who didn’t have a cardiovascular history at baseline.
Of those, 51% had normal BMI (18.5-24.9), 31% had overweight (25-29.9), and 18% had obesity (≥ 30). Cardiovascular risk factors, including LDL cholesterol, triglycerides, and hypertension increased with an increasing BMI. The 10-year CVD risk was significantly higher for those with overweight (9.61%) and obesity (9.93%) than for those with normal weight (7.24%), in both men and women.
However, BMI was found to be an independent predictor of 10-year high cardiovascular risk in men but not women, while waist:height ratio independently predicted risk in both men and women, Dr. Salle reported.
The second BMI study, from Enrique Soto-Pedre, MBBS, of the Division of Population Health and Genomics at the University of Dundee, Scotland, presented data on a retrospective follow-up from 1995 to 2019 of 1973 people with T1D aged > 18 years at diagnosis (42% women; mean age, 34.2 years; 18.9% had obesity.
After 10 years of follow-up, those with overweight and obesity had significantly higher odds of developing arterial hypertension, even among those taking angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, with statistically significant adjusted hazard ratios of 1.73 and 3.37 for the obese and overweight groups, respectively.
MACE were significantly more common among those with obesity, with an adjusted hazard ratio of 2.95, as was acute myocardial infarction, 3.33.
“These results emphasize the importance of incorporating weight management into the overall management of individuals with T1D. No one has doubts about weight management in T2D, but in type 1, it’s not so clear. One of the main [concerns] would be safety [in terms of hypoglycemia],” Dr. Soto-Pedre concluded.
Call for Action: Cumulative Glucose and Lipid Exposures Increase Risk
Dr. Bergdal presented data on the effects of cumulative glycemia and lipids on the risk for CAD in 3495 adults with T1D who had been diagnosed prior to the age of 40 years. The history of CAD or stroke was exclusion criteria. There were a total of 534 CAD events within a median follow-up of 19.4 years.
Cumulative glycemia, LDL cholesterol, triglycerides, and non–high-density lipoprotein cholesterol exposures were all significantly associated with CAD risk (P < .001 for all). With an adjustment for confounders, the highest tertile of glycemia was associated with a twofold increased risk for CAD. Both hyperglycemia and dyslipidemia were independently associated with CAD risk, Dr. Bergdal reported.
“It’s important to minimize the time spent above A1c 7%, and lipid management in T1D must not be forgotten,” she said, prior to issuing her call for action.
Dr. Haluzik reported receiving honoraria for talks and/or consultancy and/or research funding from Eli Lilly, Novo Nordisk, Sanofi, AstraZeneca, Mundipharma, Bristol Myers Squibb, Amgen, Boehringer Ingelheim, Janssen, Ypsomed, and Johnson & Johnson. The presenters had no disclosures.
A version of this article first appeared on Medscape.com.
MADRID — Emerging data points to the urgent need for cardiovascular risk reduction in all adults with type 1 diabetes (T1D), including those who are young and those diagnosed in adulthood.
At the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting, two entire oral abstract sessions were devoted to research examining cardiovascular risk specifically in people with T1D. There is increasing evidence that as with type 2 diabetes (T2D), clinical visits need to focus on other cardiovascular risk factors and glucose.
Findings included the evidence of severe coronary artery disease (CAD) in asymptomatic adults with T1D, increased risks for mortality and cardiac events in people diagnosed with T1D in adulthood, and a greater cardiovascular risk for those with overweight/obesity and among those with more cumulative exposure to both hyperglycemia and dyslipidemia.
One speaker, Dr. Rebecka Johanna Bergdal, of the Folkhälsan Research Center and the University of Helsinki, Finland, issued a “call to action,” saying, “We call on healthcare professionals to continue supporting and encouraging individuals with T1D towards better management of diabetes, including both glucose and lipid management.”
Session Moderator Krzysztof Strojek, MD, PhD, head of the Department of Internal Medicine, Diabetology and Cardiometabolic Diseases at the Medical University of Silesia, Katowice, Poland, told this news organization that all the data point in the same direction for T1D management, to “look not only at A1c and blood glucose control but also lipids, hypertension, smoking status, all these risk factors recognized in type 2 ... are also important in T1D.”
The ‘Alarming’ Finding of CAD in Asymptomatic Patients
Michal Dubsky, MD, PhD, of the Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic, presented findings from 62 asymptomatic patients with T1D for > 10 years (mean, 36 years), with a mean A1c of 7.5% (58 mmol/mol), and no prior history of cardiovascular disease (CVD). They had slightly elevated CVD biomarkers, including a mean low-density lipoprotein (LDL) cholesterol level of 2.33 mmol/L, lipoprotein (a) level of 15 nmol/L, and N-terminal pro-B-type natriuretic peptide level of 125.3 ng/L.
All underwent a noninvasive carotid ultrasound and coronary artery calcium (CAC) scoring. Of those, 12 patients had a CAC score > 400 and/or presence of two or more carotid plaques identified as high-risk.
Those 12 patients underwent coronary angiography and had a total of 29 vessels examined by optical coherence tomography (OCT), “an invasive intravascular method for assessing coronary atherosclerosis that is far more sensitive than standard coronary angiography, especially for the detection of high-risk vulnerable plaques without a hemodynamically significant stenosis,” Dr. Dubsky explained.
Coronary angiography showed obstructive CAD in 5 of the 12 patients. Their mean calcium score was 950 and mean number of carotid plaques was 2.8. Features associated with plaque vulnerability included microphage accumulation in 24 vessels, lipid-rich plaques in 23, spotty calcium in 19, and neovascularizations in 13.
Thin-cap fibroatheroma, a strong predictor of plaque rupture, was present in 7 of the 12 patients (58.3%), and four had features of very high-risk plaques, defined as thin-cap fibroatheroma with a minimal lumen area < 3.5 mm2, a lipid arch > 180 degrees, and macrophages.
“Our study showed that asymptomatic T1D patients with high CAC score and carotid plaques had very severe OCT findings. We observed a significant proportion of high-risk lesions potentially associated with plaque rupture and risk of CV death. Therefore, we believe these patients should be treated as very high-risk with target LDL below 1.4 mmol/L (55 mg/dL), even though they are completely asymptomatic,” Dr. Dubsky concluded.
He added that because OCT is invasive and costly, the CAC score can be used to guide the decision for statin use, with any score above 100 considered elevated risk.
Study coauthor Martin Haluzik, MD, professor of internal medicine in the Charles University, Prague, Czech Republic, told this news organization, “I think it’s very alarming because some of these are basically very healthy-looking young people, so you don’t really expect them to have significant cardiovascular complications already or significant plaques. I think it shows that we should be more proactive in looking into the risk of cardiovascular complications and in looking into the early cardiovascular changes.”
Later Diagnosis Doesn’t Always Protect: Risk Seen in Adult-Onset T1D
Yuxia Wei, a PhD student at the Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden, presented an analysis of data from Sweden’s national health databases comparing cardiovascular outcomes between 10,184 people diagnosed with T1D at ages 18-29 years, 30-39 years, and ≥ 40 years; another 375,523 people diagnosed with T2D at those ages; and 509,172 population controls matched for age, sex, and county.
Those diagnosed after age 40 years had higher A1c levels and were less likely to be using insulin pumps than those diagnosed at younger adult ages.
Compared with population controls, at a median of about 7 years of follow-up, people with T1D had significantly higher all-cause mortality at all diagnosis age groups, with a hazard ratio of 1.71. This rose to 2.78 for those diagnosed at age 30-39 years.
Compared with those with T2D, the mortality risks weren’t significantly different at any age, but the risks for non-cardiovascular death, including from cancer and infection, were significantly higher among those diagnosed after age 40 years (1.31 overall). Those diagnosed with T1D at any adult age had lower risks for major cardiovascular events than those diagnosed with T2D. Hazard ratios ranged from 0.27 for those diagnosed at age 18-29 years to 0.78 for those diagnosed after the age of 40 years.
Smoking and A1c above target were the greatest contributors to mortality. Those two factors, along with body mass index (BMI), were the strongest contributors to major adverse cardiovascular events (MACE).
“Adult-onset T1D carries excess risk of death and cardiovascular disease, without obvious attenuation over age at diagnosis…Smoking, A1c, and BMI are the key factors to be managed to improve prognosis in adult-onset T1D,” Ms. Wei concluded.
BMI: Often Overlooked in T1D, but a Major CVD Risk Factor
Two studies examined the link between overweight/obesity and cardiovascular risk in T1D. One, by Laurence Salle, MCU PH, of the Endocrinology, Diabetes and Metabolic Diseases Department at CHU Limoges, France, was a prospective, longitudinal cohort study of 2367 people with T1D at 68 centers in France who didn’t have a cardiovascular history at baseline.
Of those, 51% had normal BMI (18.5-24.9), 31% had overweight (25-29.9), and 18% had obesity (≥ 30). Cardiovascular risk factors, including LDL cholesterol, triglycerides, and hypertension increased with an increasing BMI. The 10-year CVD risk was significantly higher for those with overweight (9.61%) and obesity (9.93%) than for those with normal weight (7.24%), in both men and women.
However, BMI was found to be an independent predictor of 10-year high cardiovascular risk in men but not women, while waist:height ratio independently predicted risk in both men and women, Dr. Salle reported.
The second BMI study, from Enrique Soto-Pedre, MBBS, of the Division of Population Health and Genomics at the University of Dundee, Scotland, presented data on a retrospective follow-up from 1995 to 2019 of 1973 people with T1D aged > 18 years at diagnosis (42% women; mean age, 34.2 years; 18.9% had obesity.
After 10 years of follow-up, those with overweight and obesity had significantly higher odds of developing arterial hypertension, even among those taking angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, with statistically significant adjusted hazard ratios of 1.73 and 3.37 for the obese and overweight groups, respectively.
MACE were significantly more common among those with obesity, with an adjusted hazard ratio of 2.95, as was acute myocardial infarction, 3.33.
“These results emphasize the importance of incorporating weight management into the overall management of individuals with T1D. No one has doubts about weight management in T2D, but in type 1, it’s not so clear. One of the main [concerns] would be safety [in terms of hypoglycemia],” Dr. Soto-Pedre concluded.
Call for Action: Cumulative Glucose and Lipid Exposures Increase Risk
Dr. Bergdal presented data on the effects of cumulative glycemia and lipids on the risk for CAD in 3495 adults with T1D who had been diagnosed prior to the age of 40 years. The history of CAD or stroke was exclusion criteria. There were a total of 534 CAD events within a median follow-up of 19.4 years.
Cumulative glycemia, LDL cholesterol, triglycerides, and non–high-density lipoprotein cholesterol exposures were all significantly associated with CAD risk (P < .001 for all). With an adjustment for confounders, the highest tertile of glycemia was associated with a twofold increased risk for CAD. Both hyperglycemia and dyslipidemia were independently associated with CAD risk, Dr. Bergdal reported.
“It’s important to minimize the time spent above A1c 7%, and lipid management in T1D must not be forgotten,” she said, prior to issuing her call for action.
Dr. Haluzik reported receiving honoraria for talks and/or consultancy and/or research funding from Eli Lilly, Novo Nordisk, Sanofi, AstraZeneca, Mundipharma, Bristol Myers Squibb, Amgen, Boehringer Ingelheim, Janssen, Ypsomed, and Johnson & Johnson. The presenters had no disclosures.
A version of this article first appeared on Medscape.com.
FROM EASD 2024
Childhood-Onset Atopic Dermatitis Adds Burden in Adulthood
AMSTERDAM — There is a mountain of evidence that atopic dermatitis (AD) exerts a large negative impact on quality of life, but a unique study with
These data, drawn from the ambitious Scars of Life (SOL) project, “suggest that childhood AD persisting into adulthood is its own phenotype,” reported Jonathan I. Silverberg, MD, PhD, director of clinical research, Department of Dermatology, George Washington University, Washington, DC.
One reasonable message from these data is that the failure to achieve adequate control of AD in children, whether by a late start of systemic agents or other reasons, results in a greater lifetime burden of disease when the burden beyond physical symptoms is measured, according to Dr. Silverberg.
More Than 30,000 From Five Continents Participated
In the SOL project, which was designed to analyze how the age of AD onset affects the severity of symptoms and quality of life, completed questionnaires were collected from 30,801 individuals in 27 countries on five continents. The questions, which elicited data to measure the burden of AD, were developed in association with several professional and patient associations with an interest in AD, including the National Eczema Association.
The SOL project has produced an enormous amount of data in four distinct groups, but Dr. Silverberg, speaking in a late-breaking news session at the annual congress of the European Academy of Dermatology and Venereology, focused on a comparison between the 2875 participants who had AD in childhood that has persisted into adulthood and the 7383 adults with adult-onset AD. Data from the other two subsets in SOL — AD in childhood but not in adulthood and no AD in either phase of life — are expected to fuel an extended series of publications.
In the two groups, baseline characteristics were similar with about 60% reporting moderate to severe symptoms and a median age of about 37 years. The proportion of women was 61% in both groups.
Using the PUSH-D questionnaire, which Dr. Silverberg described as a validated tool for gauging a sense of stigmatization, the greater burden of AD was remarkably consistent for those with childhood-onset AD vs adult-onset AD. With higher scores representing a greater sense of stigmatization, the differences in the overall score (23.0 vs 18.1; P < .0001) were highly significant as was every other domain evaluated.
For all five social behavior domains, such as avoiding contact in public and wariness of approaching people spontaneously, having AD onset in childhood persisting into adulthood produced significantly higher scores than having AD onset in adulthood, with no exceptions (P < .001 for all).
AD From Childhood Consistently Results in Worse Outcomes
Providing examples for some of the other 12 domains, Dr. Silverberg maintained that feelings of shame and psychological discomfort were always greater in adults with AD persistent since childhood vs AD starting in adulthood. The P values for these outcomes, such as experiencing bias at work or reporting a sense that others avoided them, were typically highly significant (P < .001).
Compared with those whose AD started in adulthood, “adults with atopic eczema that started during childhood have significantly more difficulties in their life, including occupational relationships, daily life, personal life, and partner or family relationships,” Dr. Silverberg reported.
He said that the data were controlled for multiple confounders, particularly greater severity of AD. He acknowledged that childhood onset might be considered a surrogate for more severe disease, but the data were controlled for this possibility.
Despite the fact that there are “thousands of studies across all age groups showing the burden of AD,” Dr. Silverberg considers these data to be unique by emphasizing the burden of chronicity rather than the impact of AD in any single moment in time.
For those with chronic AD from childhood, “the effect is not just on physical health but a deep negative influence on psychological and social aspects of life,” Dr. Silverberg said, suggesting that the independent effects of chronicity might be worth studying across other dermatologic diseases.
“Regulatory agencies focus on what you can do in that moment of time, losing the bigger picture of how patients are affected chronically,” he said, adding that this is an area of clinical research that should be further explored.
What the data further suggest “is that the earlier we intervene, the more likely patients will do better long term,” he said.
Data Provide Evidence of Systemic Therapy in Kids
For Gudrun Ratzinger, MD, of the Department of Dermatology and Venerology at the Medical University of Innsbruck in Austria, these are valuable data.
“When I prescribe systemic therapies to children, I often get resistance from the healthcare system and even other colleagues,” said Dr. Ratzinger, who was asked to comment on the results. “We are at a teaching hospital, but I often find that when patients return to their home physician, the systemic therapies are stopped.”
In her own practice, she believes the most effective therapies should be introduced in children and adults when complete control is not achieved on first-line drugs. “These data are very helpful for me in explaining to others the importance of effective treatment of atopic dermatitis in children,” she said.
Dr. Silverberg reported financial relationships with more than 40 pharmaceutical companies, including those that make drugs for AD. Dr. Ratzinger reported financial relationships with AbbVie, Almirall, Boehringer Ingelheim, Eli Lilly, Janssen, Leo Pharma, Novartis, Pelpharma, Pfizer, and UCB.
A version of this article first appeared on Medscape.com.
AMSTERDAM — There is a mountain of evidence that atopic dermatitis (AD) exerts a large negative impact on quality of life, but a unique study with
These data, drawn from the ambitious Scars of Life (SOL) project, “suggest that childhood AD persisting into adulthood is its own phenotype,” reported Jonathan I. Silverberg, MD, PhD, director of clinical research, Department of Dermatology, George Washington University, Washington, DC.
One reasonable message from these data is that the failure to achieve adequate control of AD in children, whether by a late start of systemic agents or other reasons, results in a greater lifetime burden of disease when the burden beyond physical symptoms is measured, according to Dr. Silverberg.
More Than 30,000 From Five Continents Participated
In the SOL project, which was designed to analyze how the age of AD onset affects the severity of symptoms and quality of life, completed questionnaires were collected from 30,801 individuals in 27 countries on five continents. The questions, which elicited data to measure the burden of AD, were developed in association with several professional and patient associations with an interest in AD, including the National Eczema Association.
The SOL project has produced an enormous amount of data in four distinct groups, but Dr. Silverberg, speaking in a late-breaking news session at the annual congress of the European Academy of Dermatology and Venereology, focused on a comparison between the 2875 participants who had AD in childhood that has persisted into adulthood and the 7383 adults with adult-onset AD. Data from the other two subsets in SOL — AD in childhood but not in adulthood and no AD in either phase of life — are expected to fuel an extended series of publications.
In the two groups, baseline characteristics were similar with about 60% reporting moderate to severe symptoms and a median age of about 37 years. The proportion of women was 61% in both groups.
Using the PUSH-D questionnaire, which Dr. Silverberg described as a validated tool for gauging a sense of stigmatization, the greater burden of AD was remarkably consistent for those with childhood-onset AD vs adult-onset AD. With higher scores representing a greater sense of stigmatization, the differences in the overall score (23.0 vs 18.1; P < .0001) were highly significant as was every other domain evaluated.
For all five social behavior domains, such as avoiding contact in public and wariness of approaching people spontaneously, having AD onset in childhood persisting into adulthood produced significantly higher scores than having AD onset in adulthood, with no exceptions (P < .001 for all).
AD From Childhood Consistently Results in Worse Outcomes
Providing examples for some of the other 12 domains, Dr. Silverberg maintained that feelings of shame and psychological discomfort were always greater in adults with AD persistent since childhood vs AD starting in adulthood. The P values for these outcomes, such as experiencing bias at work or reporting a sense that others avoided them, were typically highly significant (P < .001).
Compared with those whose AD started in adulthood, “adults with atopic eczema that started during childhood have significantly more difficulties in their life, including occupational relationships, daily life, personal life, and partner or family relationships,” Dr. Silverberg reported.
He said that the data were controlled for multiple confounders, particularly greater severity of AD. He acknowledged that childhood onset might be considered a surrogate for more severe disease, but the data were controlled for this possibility.
Despite the fact that there are “thousands of studies across all age groups showing the burden of AD,” Dr. Silverberg considers these data to be unique by emphasizing the burden of chronicity rather than the impact of AD in any single moment in time.
For those with chronic AD from childhood, “the effect is not just on physical health but a deep negative influence on psychological and social aspects of life,” Dr. Silverberg said, suggesting that the independent effects of chronicity might be worth studying across other dermatologic diseases.
“Regulatory agencies focus on what you can do in that moment of time, losing the bigger picture of how patients are affected chronically,” he said, adding that this is an area of clinical research that should be further explored.
What the data further suggest “is that the earlier we intervene, the more likely patients will do better long term,” he said.
Data Provide Evidence of Systemic Therapy in Kids
For Gudrun Ratzinger, MD, of the Department of Dermatology and Venerology at the Medical University of Innsbruck in Austria, these are valuable data.
“When I prescribe systemic therapies to children, I often get resistance from the healthcare system and even other colleagues,” said Dr. Ratzinger, who was asked to comment on the results. “We are at a teaching hospital, but I often find that when patients return to their home physician, the systemic therapies are stopped.”
In her own practice, she believes the most effective therapies should be introduced in children and adults when complete control is not achieved on first-line drugs. “These data are very helpful for me in explaining to others the importance of effective treatment of atopic dermatitis in children,” she said.
Dr. Silverberg reported financial relationships with more than 40 pharmaceutical companies, including those that make drugs for AD. Dr. Ratzinger reported financial relationships with AbbVie, Almirall, Boehringer Ingelheim, Eli Lilly, Janssen, Leo Pharma, Novartis, Pelpharma, Pfizer, and UCB.
A version of this article first appeared on Medscape.com.
AMSTERDAM — There is a mountain of evidence that atopic dermatitis (AD) exerts a large negative impact on quality of life, but a unique study with
These data, drawn from the ambitious Scars of Life (SOL) project, “suggest that childhood AD persisting into adulthood is its own phenotype,” reported Jonathan I. Silverberg, MD, PhD, director of clinical research, Department of Dermatology, George Washington University, Washington, DC.
One reasonable message from these data is that the failure to achieve adequate control of AD in children, whether by a late start of systemic agents or other reasons, results in a greater lifetime burden of disease when the burden beyond physical symptoms is measured, according to Dr. Silverberg.
More Than 30,000 From Five Continents Participated
In the SOL project, which was designed to analyze how the age of AD onset affects the severity of symptoms and quality of life, completed questionnaires were collected from 30,801 individuals in 27 countries on five continents. The questions, which elicited data to measure the burden of AD, were developed in association with several professional and patient associations with an interest in AD, including the National Eczema Association.
The SOL project has produced an enormous amount of data in four distinct groups, but Dr. Silverberg, speaking in a late-breaking news session at the annual congress of the European Academy of Dermatology and Venereology, focused on a comparison between the 2875 participants who had AD in childhood that has persisted into adulthood and the 7383 adults with adult-onset AD. Data from the other two subsets in SOL — AD in childhood but not in adulthood and no AD in either phase of life — are expected to fuel an extended series of publications.
In the two groups, baseline characteristics were similar with about 60% reporting moderate to severe symptoms and a median age of about 37 years. The proportion of women was 61% in both groups.
Using the PUSH-D questionnaire, which Dr. Silverberg described as a validated tool for gauging a sense of stigmatization, the greater burden of AD was remarkably consistent for those with childhood-onset AD vs adult-onset AD. With higher scores representing a greater sense of stigmatization, the differences in the overall score (23.0 vs 18.1; P < .0001) were highly significant as was every other domain evaluated.
For all five social behavior domains, such as avoiding contact in public and wariness of approaching people spontaneously, having AD onset in childhood persisting into adulthood produced significantly higher scores than having AD onset in adulthood, with no exceptions (P < .001 for all).
AD From Childhood Consistently Results in Worse Outcomes
Providing examples for some of the other 12 domains, Dr. Silverberg maintained that feelings of shame and psychological discomfort were always greater in adults with AD persistent since childhood vs AD starting in adulthood. The P values for these outcomes, such as experiencing bias at work or reporting a sense that others avoided them, were typically highly significant (P < .001).
Compared with those whose AD started in adulthood, “adults with atopic eczema that started during childhood have significantly more difficulties in their life, including occupational relationships, daily life, personal life, and partner or family relationships,” Dr. Silverberg reported.
He said that the data were controlled for multiple confounders, particularly greater severity of AD. He acknowledged that childhood onset might be considered a surrogate for more severe disease, but the data were controlled for this possibility.
Despite the fact that there are “thousands of studies across all age groups showing the burden of AD,” Dr. Silverberg considers these data to be unique by emphasizing the burden of chronicity rather than the impact of AD in any single moment in time.
For those with chronic AD from childhood, “the effect is not just on physical health but a deep negative influence on psychological and social aspects of life,” Dr. Silverberg said, suggesting that the independent effects of chronicity might be worth studying across other dermatologic diseases.
“Regulatory agencies focus on what you can do in that moment of time, losing the bigger picture of how patients are affected chronically,” he said, adding that this is an area of clinical research that should be further explored.
What the data further suggest “is that the earlier we intervene, the more likely patients will do better long term,” he said.
Data Provide Evidence of Systemic Therapy in Kids
For Gudrun Ratzinger, MD, of the Department of Dermatology and Venerology at the Medical University of Innsbruck in Austria, these are valuable data.
“When I prescribe systemic therapies to children, I often get resistance from the healthcare system and even other colleagues,” said Dr. Ratzinger, who was asked to comment on the results. “We are at a teaching hospital, but I often find that when patients return to their home physician, the systemic therapies are stopped.”
In her own practice, she believes the most effective therapies should be introduced in children and adults when complete control is not achieved on first-line drugs. “These data are very helpful for me in explaining to others the importance of effective treatment of atopic dermatitis in children,” she said.
Dr. Silverberg reported financial relationships with more than 40 pharmaceutical companies, including those that make drugs for AD. Dr. Ratzinger reported financial relationships with AbbVie, Almirall, Boehringer Ingelheim, Eli Lilly, Janssen, Leo Pharma, Novartis, Pelpharma, Pfizer, and UCB.
A version of this article first appeared on Medscape.com.
FROM EADV 2024
Sex and Gender Influence Outcomes in Colorectal Cancer
BARCELONA, SPAIN — , according to experts speaking here at the European Society for Medical Oncology (ESMO) Annual Meeting 2024.
“The concepts of gender and sex are not at all new in oncology, but what is needed is a renewed focus on them and the prospective collection of data in this regard,” said Kathrin Heinrich, MD, of University Hospital LMU Munich, Germany.
Sex and Gender: What’s New?
Speaking at the conference, Dr. Heinrich cited a 2020 study published in The Lancet that stated, “Sex and gender are the foundation of precision medicine, and their differences should guide decision-making processes to promote gender equity.”
Sex differences have clear biological and pathophysiological consequences in oncology. Available data show differences between men and women in terms of gene expression, epigenetics, metabolomics, tumor microenvironment, immune system, and microbiome. These are all critical for understanding tumor biology and identifying new treatments.
Colorectal cancer provides an excellent example of how sex differences can influence treatment outcomes.
From an incidence perspective, the numbers reported by the large epidemiological GLOBOCAN study are quite similar between the two sexes, with men accounting for 56% of patients and women for 44%.
However, there are noticeable differences in tumor characteristics, with women more frequently presenting with right-sided colon tumors and BRAF mutations; both features associated with a worse prognosis.
Sex also affects body composition, influencing the percentage of metabolically active body mass, which can alter the effectiveness and distribution of a drug and the necessary dose to achieve the desired effect.
“Despite this evidence, clinical practice often overlooks differences between the sexes when planning therapies,” Dr. Heinrich said, also recalling how in many cases the side effects of treatments — from chemotherapy to immunotherapy — differ in intensity and type between men and women.
Toward a More Targeted and Inclusive Approach
Sex is a well-defined concept from a biological standpoint and, consequently, the differences between the sexes are easy to identify. Analyzing gender differences is much more complex.
“It is not enough to tick the male or female box on a questionnaire. It is necessary to consider more complex aspects to measure, such as identity, role, and gender relations,” Dr. Heinrich said, also presenting a list of specific questionnaires to assess these components.
In today’s oncology, however, such questionnaires are mainly used to analyze secondary outcomes such as quality of life, while examples from other areas of medicine, particularly cardiology, show how questionnaires on gender can predict some clinical outcomes better than those on sex alone and that studies considering sex and gender are feasible.
Gender identity influences many aspects of health, such as attitudes toward prevention, the seeking of information and medical care, and risk behaviors. “The new approach to discussing sex and gender in oncology is to consider these factors in therapeutic decisions,” Dr. Heinrich said. “I hope that within a few years this will be fully achievable, thanks to the inclusion in our studies of gender scores, ad hoc patient-reported outcomes, and information related, for example, to menopausal status or the number of pregnancies,” she added.
To harness the differences between sex and gender in favor of the patient, however, it is also necessary to change the approach to clinical studies. Currently, data on these aspects are typically collected retrospectively. However, they should be integrated prospectively from the study’s beginning.
“We look at increasingly smaller subgroups of patients, at mutations affecting 1%-2% of our patients, but we do not collect data on sex or menopausal status, which are actually extremely simple to record,” Dr. Heinrich said, calling for more inclusive studies, especially involving the LGBTQI+ community, traditionally excluded from clinical trials and many services.
“Fortunately, we live in an era in which sensitivity towards this community is continuously increasing. We must gather information on this population, which fully belongs to what we scientifically define as the ‘real-world’ approach.”
Dr. Heinrich declared honoraria, consulting and advisory roles, and travel support from several companies, including Amgen, BMS, Merck, MSD, Roche-Janssen, Taiho, Servier, and Streamed Up.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
BARCELONA, SPAIN — , according to experts speaking here at the European Society for Medical Oncology (ESMO) Annual Meeting 2024.
“The concepts of gender and sex are not at all new in oncology, but what is needed is a renewed focus on them and the prospective collection of data in this regard,” said Kathrin Heinrich, MD, of University Hospital LMU Munich, Germany.
Sex and Gender: What’s New?
Speaking at the conference, Dr. Heinrich cited a 2020 study published in The Lancet that stated, “Sex and gender are the foundation of precision medicine, and their differences should guide decision-making processes to promote gender equity.”
Sex differences have clear biological and pathophysiological consequences in oncology. Available data show differences between men and women in terms of gene expression, epigenetics, metabolomics, tumor microenvironment, immune system, and microbiome. These are all critical for understanding tumor biology and identifying new treatments.
Colorectal cancer provides an excellent example of how sex differences can influence treatment outcomes.
From an incidence perspective, the numbers reported by the large epidemiological GLOBOCAN study are quite similar between the two sexes, with men accounting for 56% of patients and women for 44%.
However, there are noticeable differences in tumor characteristics, with women more frequently presenting with right-sided colon tumors and BRAF mutations; both features associated with a worse prognosis.
Sex also affects body composition, influencing the percentage of metabolically active body mass, which can alter the effectiveness and distribution of a drug and the necessary dose to achieve the desired effect.
“Despite this evidence, clinical practice often overlooks differences between the sexes when planning therapies,” Dr. Heinrich said, also recalling how in many cases the side effects of treatments — from chemotherapy to immunotherapy — differ in intensity and type between men and women.
Toward a More Targeted and Inclusive Approach
Sex is a well-defined concept from a biological standpoint and, consequently, the differences between the sexes are easy to identify. Analyzing gender differences is much more complex.
“It is not enough to tick the male or female box on a questionnaire. It is necessary to consider more complex aspects to measure, such as identity, role, and gender relations,” Dr. Heinrich said, also presenting a list of specific questionnaires to assess these components.
In today’s oncology, however, such questionnaires are mainly used to analyze secondary outcomes such as quality of life, while examples from other areas of medicine, particularly cardiology, show how questionnaires on gender can predict some clinical outcomes better than those on sex alone and that studies considering sex and gender are feasible.
Gender identity influences many aspects of health, such as attitudes toward prevention, the seeking of information and medical care, and risk behaviors. “The new approach to discussing sex and gender in oncology is to consider these factors in therapeutic decisions,” Dr. Heinrich said. “I hope that within a few years this will be fully achievable, thanks to the inclusion in our studies of gender scores, ad hoc patient-reported outcomes, and information related, for example, to menopausal status or the number of pregnancies,” she added.
To harness the differences between sex and gender in favor of the patient, however, it is also necessary to change the approach to clinical studies. Currently, data on these aspects are typically collected retrospectively. However, they should be integrated prospectively from the study’s beginning.
“We look at increasingly smaller subgroups of patients, at mutations affecting 1%-2% of our patients, but we do not collect data on sex or menopausal status, which are actually extremely simple to record,” Dr. Heinrich said, calling for more inclusive studies, especially involving the LGBTQI+ community, traditionally excluded from clinical trials and many services.
“Fortunately, we live in an era in which sensitivity towards this community is continuously increasing. We must gather information on this population, which fully belongs to what we scientifically define as the ‘real-world’ approach.”
Dr. Heinrich declared honoraria, consulting and advisory roles, and travel support from several companies, including Amgen, BMS, Merck, MSD, Roche-Janssen, Taiho, Servier, and Streamed Up.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
BARCELONA, SPAIN — , according to experts speaking here at the European Society for Medical Oncology (ESMO) Annual Meeting 2024.
“The concepts of gender and sex are not at all new in oncology, but what is needed is a renewed focus on them and the prospective collection of data in this regard,” said Kathrin Heinrich, MD, of University Hospital LMU Munich, Germany.
Sex and Gender: What’s New?
Speaking at the conference, Dr. Heinrich cited a 2020 study published in The Lancet that stated, “Sex and gender are the foundation of precision medicine, and their differences should guide decision-making processes to promote gender equity.”
Sex differences have clear biological and pathophysiological consequences in oncology. Available data show differences between men and women in terms of gene expression, epigenetics, metabolomics, tumor microenvironment, immune system, and microbiome. These are all critical for understanding tumor biology and identifying new treatments.
Colorectal cancer provides an excellent example of how sex differences can influence treatment outcomes.
From an incidence perspective, the numbers reported by the large epidemiological GLOBOCAN study are quite similar between the two sexes, with men accounting for 56% of patients and women for 44%.
However, there are noticeable differences in tumor characteristics, with women more frequently presenting with right-sided colon tumors and BRAF mutations; both features associated with a worse prognosis.
Sex also affects body composition, influencing the percentage of metabolically active body mass, which can alter the effectiveness and distribution of a drug and the necessary dose to achieve the desired effect.
“Despite this evidence, clinical practice often overlooks differences between the sexes when planning therapies,” Dr. Heinrich said, also recalling how in many cases the side effects of treatments — from chemotherapy to immunotherapy — differ in intensity and type between men and women.
Toward a More Targeted and Inclusive Approach
Sex is a well-defined concept from a biological standpoint and, consequently, the differences between the sexes are easy to identify. Analyzing gender differences is much more complex.
“It is not enough to tick the male or female box on a questionnaire. It is necessary to consider more complex aspects to measure, such as identity, role, and gender relations,” Dr. Heinrich said, also presenting a list of specific questionnaires to assess these components.
In today’s oncology, however, such questionnaires are mainly used to analyze secondary outcomes such as quality of life, while examples from other areas of medicine, particularly cardiology, show how questionnaires on gender can predict some clinical outcomes better than those on sex alone and that studies considering sex and gender are feasible.
Gender identity influences many aspects of health, such as attitudes toward prevention, the seeking of information and medical care, and risk behaviors. “The new approach to discussing sex and gender in oncology is to consider these factors in therapeutic decisions,” Dr. Heinrich said. “I hope that within a few years this will be fully achievable, thanks to the inclusion in our studies of gender scores, ad hoc patient-reported outcomes, and information related, for example, to menopausal status or the number of pregnancies,” she added.
To harness the differences between sex and gender in favor of the patient, however, it is also necessary to change the approach to clinical studies. Currently, data on these aspects are typically collected retrospectively. However, they should be integrated prospectively from the study’s beginning.
“We look at increasingly smaller subgroups of patients, at mutations affecting 1%-2% of our patients, but we do not collect data on sex or menopausal status, which are actually extremely simple to record,” Dr. Heinrich said, calling for more inclusive studies, especially involving the LGBTQI+ community, traditionally excluded from clinical trials and many services.
“Fortunately, we live in an era in which sensitivity towards this community is continuously increasing. We must gather information on this population, which fully belongs to what we scientifically define as the ‘real-world’ approach.”
Dr. Heinrich declared honoraria, consulting and advisory roles, and travel support from several companies, including Amgen, BMS, Merck, MSD, Roche-Janssen, Taiho, Servier, and Streamed Up.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
FROM ESMO CONGRESS 2024
Dr. Rogers’ Neighborhood: Guinea Pigs and Groundbreaking Cancer Care
Sometimes, however, Dr. Rogers’ guinea pigs pay visits to her workplace. Every Halloween, she dresses them up and shows off their photos to just about everyone. Patients, coworkers, and even random people in the elevator get glimpses of the furry pair, who pose as dinosaurs, bats, aquarium shrimp, sharks, spiders, and bumblebees.
“Being in the hospital is not funny, but guinea pigs dressed up for Halloween is incredibly funny,” Dr. Rogers said. “They make a lot of people smile.”
For physician-scientist Dr. Rogers, a native of suburban Chicago, quality of life for patients is a priority, even when she’s not trying to entertain them and lift their spirits.
The field of hematology “is trying to figure out not only what’s biologically effective for disease, but also what might be best for people living with the condition,” she said. “This is especially true in terms of patient preference for a treatment you complete vs an ongoing or continuous treatment. I really like this idea of having more attention paid to what matters to patients, which the field of medicine sometimes forgets.”
In an interview, Dr. Rogers spoke about the appeal of storytelling in medicine, advances in treatment for CLL and hairy cell leukemia, and the challenges of college football loyalty.
How did you get drawn to medicine?
Ever since I was a kid, I thought, “Oh, I really want to be a doctor. That sounds fun.” At its core, medicine blends things I really like: science, helping people with a problem, and storytelling.
The practice of medicine is a lot about stories — talking to people, figuring out what they’re telling you about what’s going on, then explaining what you know in a way that makes sense to them.
What changes have you seen in leukemia care during your career?
The biggest change is the move from chemotherapies to targeted agents. When I first did a fellowship here at Ohio State, we had studies of ibrutinib, the first-in-class covalent Bruton tyrosine kinase (BTK) inhibitor. We’d see patients who’d been on chemotherapy for the past 10 or 15 years, and then they got in a clinical trial. Ibrutinib worked better than any of the chemotherapy, and they felt better and had fewer side effects.
Now, chemoimmunotherapy is not recommended for CLL, and you can see the impact of targeted agents on the lives of patients. Instead of telling people they need to put aside work and personal plans to take intensive chemotherapy for 6 months, you say: “You’ve got to come to some more appointments to make sure the treatment is going well, and you don’t have too many side effects. But you can expect to continue to work full-time and go to your niece’s wedding out of state or whatever else you want to do.”
What are you most excited about working on?
I’m the principal investigator of a study combining obinutuzumab, ibrutinib, and venetoclax for a fixed duration, a defined treatment course of a little over a year. I just reported the median progression-free survival for phase 2 at the European Hematology Association meeting this spring. It was over 7 years for both patients who had prior treatment and those who hadn’t.
The idea that people could take a year of treatment and get a huge benefit after completing it is quite important. The regimen has gone into phase 3 testing, and we’re now trying to understand the impact in terms of which patients got longer responses or which didn’t.
What are some challenges that remain in CLL?
There are still patients whose CLL becomes resistant to our two most commonly used classes of agents: BTK inhibitors and the BLC2 inhibitor, venetoclax. There are some more BCL2 inhibitors in development, but venetoclax is the only one currently approved.
I am also principal investigator on another study that added venetoclax to ibrutinib when resistance mutations developed that would predict ultimate resistance to ibrutinib. The median progression-free survival in that study was 40.7 months, whereas the expectation with venetoclax alone is 24 months. So, it really improved the amount of time people were in remission. This study is ongoing.
We’ve just started a phase 2 study to have patients take pirtobrutinib, a noncovalent BTK inhibitor, in combination with venetoclax in cases where CLL has become resistant to a covalent BTK inhibitor. Patients will take this combination for about a year and a half.
It’s been really exciting to see the impact of some of these combinations both as first-line CLL treatment and in CLL that’s become resistant. But trying to understand what predicts response is a harder thing. I wish I knew the answers for what causes this synergy between those two classes of drugs.
You also specialize in hairy cell leukemia. Could you talk about what it is?
CLL is the most prevalent adult leukemia in the Western world, whereas hairy cell leukemia is very rare. It’s a slow-growing B-cell cancer that got its name because under the microscope, the cells have hairy projections on them.
It had a survival of only about 2-4 years before the development of purine analogs. After a course of pentostatin or cladribine (2-chlordeoxyadenosine), some people never need treatment again in our natural lifespan.
But some patients don’t benefit from purine analogs, either because they have a devastating infection that makes them unsuitable or for another reason. Or they end up needing treatment every 2-3 years, which isn’t something you want to do for 30 years of someone’s lifespan.
What are some challenges in hairy cell leukemia?
It’s a rare condition, so it can be hard to do a really large clinical trial. A lot of physicians think that the prognosis is good and miss out on an opportunity for better treatment and to generate new knowledge.
Also, some people perceive that it’s not actually a problem for people living with it. Cladribine and pentostatin are not terrible chemotherapies, and most people tolerate them very well. But we can make treatment for hairy cell more effective and more tolerable for our patients if we put more effort into researching it.
I’ve heard that you’re a big college football fan. How do you balance your history as a University of Michigan medical school alum with your work for archrival Ohio State?
I went to Northwestern for undergrad, as did several people in my family. So, I usually just claim Northwestern is my football affiliation. It doesn’t inspire much vitriol if you cheer for Northwestern!
And I understand that you live with a pair of guinea pigs. Do tell.
I adopted guinea pigs as pets in medical school. They’re cute and friendly, and they make all this noise for you when you come home. 
Once, one of my clinic patients said, “I don’t want to be your guinea pig.” I thought, “you should be so lucky.” They have quite a lifestyle: They’ve trained me to bring them vegetables, they nap most of the time, and they have a play space, a guinea pig playground.
I thought I liked the guinea pigs more than they liked me. But last fall, I was gone for about 10 days. When I got back, I’d never heard them make so much noise. They were extremely happy to see me. Then for the next 48 hours, one would randomly start whistling for me to come over. I thought, “oh, these things do like me a little bit.”
Dr. Rogers disclosed receiving research funding from Genentech, AbbVie, Novartis, and AstraZeneca and consulting/advisory relationships with AstraZeneca, AbbVie, Genentech, Janssen, Pharmacyclics, BeiGene, Loxo@Lilly, and Alpine Immune Sciences.
A version of this article first appeared on Medscape.com.
Sometimes, however, Dr. Rogers’ guinea pigs pay visits to her workplace. Every Halloween, she dresses them up and shows off their photos to just about everyone. Patients, coworkers, and even random people in the elevator get glimpses of the furry pair, who pose as dinosaurs, bats, aquarium shrimp, sharks, spiders, and bumblebees.
“Being in the hospital is not funny, but guinea pigs dressed up for Halloween is incredibly funny,” Dr. Rogers said. “They make a lot of people smile.”
For physician-scientist Dr. Rogers, a native of suburban Chicago, quality of life for patients is a priority, even when she’s not trying to entertain them and lift their spirits.
The field of hematology “is trying to figure out not only what’s biologically effective for disease, but also what might be best for people living with the condition,” she said. “This is especially true in terms of patient preference for a treatment you complete vs an ongoing or continuous treatment. I really like this idea of having more attention paid to what matters to patients, which the field of medicine sometimes forgets.”
In an interview, Dr. Rogers spoke about the appeal of storytelling in medicine, advances in treatment for CLL and hairy cell leukemia, and the challenges of college football loyalty.
How did you get drawn to medicine?
Ever since I was a kid, I thought, “Oh, I really want to be a doctor. That sounds fun.” At its core, medicine blends things I really like: science, helping people with a problem, and storytelling.
The practice of medicine is a lot about stories — talking to people, figuring out what they’re telling you about what’s going on, then explaining what you know in a way that makes sense to them.
What changes have you seen in leukemia care during your career?
The biggest change is the move from chemotherapies to targeted agents. When I first did a fellowship here at Ohio State, we had studies of ibrutinib, the first-in-class covalent Bruton tyrosine kinase (BTK) inhibitor. We’d see patients who’d been on chemotherapy for the past 10 or 15 years, and then they got in a clinical trial. Ibrutinib worked better than any of the chemotherapy, and they felt better and had fewer side effects.
Now, chemoimmunotherapy is not recommended for CLL, and you can see the impact of targeted agents on the lives of patients. Instead of telling people they need to put aside work and personal plans to take intensive chemotherapy for 6 months, you say: “You’ve got to come to some more appointments to make sure the treatment is going well, and you don’t have too many side effects. But you can expect to continue to work full-time and go to your niece’s wedding out of state or whatever else you want to do.”
What are you most excited about working on?
I’m the principal investigator of a study combining obinutuzumab, ibrutinib, and venetoclax for a fixed duration, a defined treatment course of a little over a year. I just reported the median progression-free survival for phase 2 at the European Hematology Association meeting this spring. It was over 7 years for both patients who had prior treatment and those who hadn’t.
The idea that people could take a year of treatment and get a huge benefit after completing it is quite important. The regimen has gone into phase 3 testing, and we’re now trying to understand the impact in terms of which patients got longer responses or which didn’t.
What are some challenges that remain in CLL?
There are still patients whose CLL becomes resistant to our two most commonly used classes of agents: BTK inhibitors and the BLC2 inhibitor, venetoclax. There are some more BCL2 inhibitors in development, but venetoclax is the only one currently approved.
I am also principal investigator on another study that added venetoclax to ibrutinib when resistance mutations developed that would predict ultimate resistance to ibrutinib. The median progression-free survival in that study was 40.7 months, whereas the expectation with venetoclax alone is 24 months. So, it really improved the amount of time people were in remission. This study is ongoing.
We’ve just started a phase 2 study to have patients take pirtobrutinib, a noncovalent BTK inhibitor, in combination with venetoclax in cases where CLL has become resistant to a covalent BTK inhibitor. Patients will take this combination for about a year and a half.
It’s been really exciting to see the impact of some of these combinations both as first-line CLL treatment and in CLL that’s become resistant. But trying to understand what predicts response is a harder thing. I wish I knew the answers for what causes this synergy between those two classes of drugs.
You also specialize in hairy cell leukemia. Could you talk about what it is?
CLL is the most prevalent adult leukemia in the Western world, whereas hairy cell leukemia is very rare. It’s a slow-growing B-cell cancer that got its name because under the microscope, the cells have hairy projections on them.
It had a survival of only about 2-4 years before the development of purine analogs. After a course of pentostatin or cladribine (2-chlordeoxyadenosine), some people never need treatment again in our natural lifespan.
But some patients don’t benefit from purine analogs, either because they have a devastating infection that makes them unsuitable or for another reason. Or they end up needing treatment every 2-3 years, which isn’t something you want to do for 30 years of someone’s lifespan.
What are some challenges in hairy cell leukemia?
It’s a rare condition, so it can be hard to do a really large clinical trial. A lot of physicians think that the prognosis is good and miss out on an opportunity for better treatment and to generate new knowledge.
Also, some people perceive that it’s not actually a problem for people living with it. Cladribine and pentostatin are not terrible chemotherapies, and most people tolerate them very well. But we can make treatment for hairy cell more effective and more tolerable for our patients if we put more effort into researching it.
I’ve heard that you’re a big college football fan. How do you balance your history as a University of Michigan medical school alum with your work for archrival Ohio State?
I went to Northwestern for undergrad, as did several people in my family. So, I usually just claim Northwestern is my football affiliation. It doesn’t inspire much vitriol if you cheer for Northwestern!
And I understand that you live with a pair of guinea pigs. Do tell.
I adopted guinea pigs as pets in medical school. They’re cute and friendly, and they make all this noise for you when you come home.
Once, one of my clinic patients said, “I don’t want to be your guinea pig.” I thought, “you should be so lucky.” They have quite a lifestyle: They’ve trained me to bring them vegetables, they nap most of the time, and they have a play space, a guinea pig playground.
I thought I liked the guinea pigs more than they liked me. But last fall, I was gone for about 10 days. When I got back, I’d never heard them make so much noise. They were extremely happy to see me. Then for the next 48 hours, one would randomly start whistling for me to come over. I thought, “oh, these things do like me a little bit.”
Dr. Rogers disclosed receiving research funding from Genentech, AbbVie, Novartis, and AstraZeneca and consulting/advisory relationships with AstraZeneca, AbbVie, Genentech, Janssen, Pharmacyclics, BeiGene, Loxo@Lilly, and Alpine Immune Sciences.
A version of this article first appeared on Medscape.com.
Sometimes, however, Dr. Rogers’ guinea pigs pay visits to her workplace. Every Halloween, she dresses them up and shows off their photos to just about everyone. Patients, coworkers, and even random people in the elevator get glimpses of the furry pair, who pose as dinosaurs, bats, aquarium shrimp, sharks, spiders, and bumblebees.
“Being in the hospital is not funny, but guinea pigs dressed up for Halloween is incredibly funny,” Dr. Rogers said. “They make a lot of people smile.”
For physician-scientist Dr. Rogers, a native of suburban Chicago, quality of life for patients is a priority, even when she’s not trying to entertain them and lift their spirits.
The field of hematology “is trying to figure out not only what’s biologically effective for disease, but also what might be best for people living with the condition,” she said. “This is especially true in terms of patient preference for a treatment you complete vs an ongoing or continuous treatment. I really like this idea of having more attention paid to what matters to patients, which the field of medicine sometimes forgets.”
In an interview, Dr. Rogers spoke about the appeal of storytelling in medicine, advances in treatment for CLL and hairy cell leukemia, and the challenges of college football loyalty.
How did you get drawn to medicine?
Ever since I was a kid, I thought, “Oh, I really want to be a doctor. That sounds fun.” At its core, medicine blends things I really like: science, helping people with a problem, and storytelling.
The practice of medicine is a lot about stories — talking to people, figuring out what they’re telling you about what’s going on, then explaining what you know in a way that makes sense to them.
What changes have you seen in leukemia care during your career?
The biggest change is the move from chemotherapies to targeted agents. When I first did a fellowship here at Ohio State, we had studies of ibrutinib, the first-in-class covalent Bruton tyrosine kinase (BTK) inhibitor. We’d see patients who’d been on chemotherapy for the past 10 or 15 years, and then they got in a clinical trial. Ibrutinib worked better than any of the chemotherapy, and they felt better and had fewer side effects.
Now, chemoimmunotherapy is not recommended for CLL, and you can see the impact of targeted agents on the lives of patients. Instead of telling people they need to put aside work and personal plans to take intensive chemotherapy for 6 months, you say: “You’ve got to come to some more appointments to make sure the treatment is going well, and you don’t have too many side effects. But you can expect to continue to work full-time and go to your niece’s wedding out of state or whatever else you want to do.”
What are you most excited about working on?
I’m the principal investigator of a study combining obinutuzumab, ibrutinib, and venetoclax for a fixed duration, a defined treatment course of a little over a year. I just reported the median progression-free survival for phase 2 at the European Hematology Association meeting this spring. It was over 7 years for both patients who had prior treatment and those who hadn’t.
The idea that people could take a year of treatment and get a huge benefit after completing it is quite important. The regimen has gone into phase 3 testing, and we’re now trying to understand the impact in terms of which patients got longer responses or which didn’t.
What are some challenges that remain in CLL?
There are still patients whose CLL becomes resistant to our two most commonly used classes of agents: BTK inhibitors and the BLC2 inhibitor, venetoclax. There are some more BCL2 inhibitors in development, but venetoclax is the only one currently approved.
I am also principal investigator on another study that added venetoclax to ibrutinib when resistance mutations developed that would predict ultimate resistance to ibrutinib. The median progression-free survival in that study was 40.7 months, whereas the expectation with venetoclax alone is 24 months. So, it really improved the amount of time people were in remission. This study is ongoing.
We’ve just started a phase 2 study to have patients take pirtobrutinib, a noncovalent BTK inhibitor, in combination with venetoclax in cases where CLL has become resistant to a covalent BTK inhibitor. Patients will take this combination for about a year and a half.
It’s been really exciting to see the impact of some of these combinations both as first-line CLL treatment and in CLL that’s become resistant. But trying to understand what predicts response is a harder thing. I wish I knew the answers for what causes this synergy between those two classes of drugs.
You also specialize in hairy cell leukemia. Could you talk about what it is?
CLL is the most prevalent adult leukemia in the Western world, whereas hairy cell leukemia is very rare. It’s a slow-growing B-cell cancer that got its name because under the microscope, the cells have hairy projections on them.
It had a survival of only about 2-4 years before the development of purine analogs. After a course of pentostatin or cladribine (2-chlordeoxyadenosine), some people never need treatment again in our natural lifespan.
But some patients don’t benefit from purine analogs, either because they have a devastating infection that makes them unsuitable or for another reason. Or they end up needing treatment every 2-3 years, which isn’t something you want to do for 30 years of someone’s lifespan.
What are some challenges in hairy cell leukemia?
It’s a rare condition, so it can be hard to do a really large clinical trial. A lot of physicians think that the prognosis is good and miss out on an opportunity for better treatment and to generate new knowledge.
Also, some people perceive that it’s not actually a problem for people living with it. Cladribine and pentostatin are not terrible chemotherapies, and most people tolerate them very well. But we can make treatment for hairy cell more effective and more tolerable for our patients if we put more effort into researching it.
I’ve heard that you’re a big college football fan. How do you balance your history as a University of Michigan medical school alum with your work for archrival Ohio State?
I went to Northwestern for undergrad, as did several people in my family. So, I usually just claim Northwestern is my football affiliation. It doesn’t inspire much vitriol if you cheer for Northwestern!
And I understand that you live with a pair of guinea pigs. Do tell.
I adopted guinea pigs as pets in medical school. They’re cute and friendly, and they make all this noise for you when you come home.
Once, one of my clinic patients said, “I don’t want to be your guinea pig.” I thought, “you should be so lucky.” They have quite a lifestyle: They’ve trained me to bring them vegetables, they nap most of the time, and they have a play space, a guinea pig playground.
I thought I liked the guinea pigs more than they liked me. But last fall, I was gone for about 10 days. When I got back, I’d never heard them make so much noise. They were extremely happy to see me. Then for the next 48 hours, one would randomly start whistling for me to come over. I thought, “oh, these things do like me a little bit.”
Dr. Rogers disclosed receiving research funding from Genentech, AbbVie, Novartis, and AstraZeneca and consulting/advisory relationships with AstraZeneca, AbbVie, Genentech, Janssen, Pharmacyclics, BeiGene, Loxo@Lilly, and Alpine Immune Sciences.
A version of this article first appeared on Medscape.com.
Nasal Staph Aureus Carriage Linked to Surgical Infections
published in the August issue of Open Forum Infectious Diseases.
“This was a pan-European study with many hospitals, many different clinical settings, and as far as I’m aware, it hasn’t been done before. [The new study] covers a lot of European countries and a lot of surgical specialties,” said lead author Jan Kluytmans, MD. The study also captures the current state of preventive strategies in surgery, such as changes in air flow, dress, and skin preparation, he added.
The study included 5004 patients from 33 hospitals in ten European countries, of whom 67.3% were found to be SA carriers. The median age was 65 years, and 49.8% of patients were male. Open cardiac, and knee and hip prosthesis surgeries made up the largest fraction, but there were 12 types of surgery included in the study.
There were 100 SA surgical site or blood infections. The researchers found an association between surgical site or blood infection and SA carriage at any site (adjusted hazard ratio [aHR], 4.6; 95% CI, 2.1-10.0) and nasal SA carriage (aHR, 4.2; 95% CI, 2.0-8.6). Extranasal SA carriage was not associated with an increased infection risk.
Each 1-unit increase in nasal bacteria was associated with an increase in infection risk (aHR, 1.23; 95% CI, 1.05-1.43).
A strength of the study is that it is the largest prospective study yet conducted on SA carriage in surgical patients, but the researchers were unable to do a subgroup of methicillin-resistant SA (MRSA) due to small numbers of infections.
The study confirms the value of the decolonization strategy, which the World Health Organization has endorsed with the highest level of scientific evidence that is available in preventive strategies in surgery. WHO strongly recommends decolonization for cardiothoracic and orthopedic surgery using intranasal applications of mupirocin 2% ointment with or without a combination of chlorhexidine gluconate body wash. It has a conditional recommendation for a similar procedure before other types of surgery.
However, “It is not widely practiced, and although that was not a surprise to me, I think it’s really disappointing to see that proven effective strategies are not being practiced,” said Dr. Kluytmans, professor of medical microbiology at University Medical Center Utrecht, Utrecht University, the Netherlands. “If I would come into surgery being a carrier, and not be decolonized, I would really be quite angry because it puts you at risk, which is preventable. I think that’s something we owe to our patients,” he said.
He said that some may have concerns about the potential for decolonization to contribute to antibiotic resistance, but the short-term prophylaxis — typically a few days — should not foster resistance, according to Dr. Kluytmans. “If you use it short term, just before surgery, it has been shown in many studies that resistance isn’t a big problem and it can be monitored.”
The link specifically to SA nasal carriage is a mystery, according to Dr. Kluytmans. “It puzzles me still how it gets from the nares to the wound during surgery. So that’s my million-dollar question that I would like to resolve. We would like to study it, but we haven’t quite a bright idea how to do that,” he said.
The results are compelling, according to Heather Evans, MD, who was asked for comment. “On the face of it, this looks like a no-brainer. We should be decolonizing all patients that go to the operating room, and it’s not a terribly unpleasant thing for a patient to undergo to have decolonization done. Particularly for patients who are at higher risk for having a severe complication, like someone that has an operation that’s involving an implant, for example, I think it really makes a lot of sense to do this low-cost intervention for those patients,” said Dr. Evans, professor of medicine at The Medical University of South Carolina as well as the president of the Surgical Infection Society.
She noted that many facilities test for methicillin-resistant SA, but usual not SA more broadly. “This is a very interesting and compelling study that makes us rethink that, and maybe it isn’t even worth testing to see if you have staph aureus, maybe we should just be putting Betadine in everyone’s nostrils when they come to the operating room. It just seems like it would be a pretty low-cost intervention and something that could potentially have a big impact,” said Dr. Evans.
Although she was impressed by the study, Dr. Evans noted that the researchers tested for carriage at sites unrelated to the surgical site. “It really made me wonder if it would have added even more credibility to the study if there had been a sample taken after surgical prep was done to demonstrate that there is actually no staph aureus present on the skin at the time that the wound was made,” she said.
The question ties into the recent “Trojan horse” hypothesis, which suggests that endemic carriage of bacteria is responsible for most surgical site infections, rather than the long-held belief that operating room contamination is to blame. “That would sort of fly with this study, that the patient is walking around with Staph aureus and not necessarily on their skin or at their surgical site, but it’s endemic in their body,” said Dr. Evans.
Dr. Kluytmans and Dr. Evans have no relevant financial disclosures.
published in the August issue of Open Forum Infectious Diseases.
“This was a pan-European study with many hospitals, many different clinical settings, and as far as I’m aware, it hasn’t been done before. [The new study] covers a lot of European countries and a lot of surgical specialties,” said lead author Jan Kluytmans, MD. The study also captures the current state of preventive strategies in surgery, such as changes in air flow, dress, and skin preparation, he added.
The study included 5004 patients from 33 hospitals in ten European countries, of whom 67.3% were found to be SA carriers. The median age was 65 years, and 49.8% of patients were male. Open cardiac, and knee and hip prosthesis surgeries made up the largest fraction, but there were 12 types of surgery included in the study.
There were 100 SA surgical site or blood infections. The researchers found an association between surgical site or blood infection and SA carriage at any site (adjusted hazard ratio [aHR], 4.6; 95% CI, 2.1-10.0) and nasal SA carriage (aHR, 4.2; 95% CI, 2.0-8.6). Extranasal SA carriage was not associated with an increased infection risk.
Each 1-unit increase in nasal bacteria was associated with an increase in infection risk (aHR, 1.23; 95% CI, 1.05-1.43).
A strength of the study is that it is the largest prospective study yet conducted on SA carriage in surgical patients, but the researchers were unable to do a subgroup of methicillin-resistant SA (MRSA) due to small numbers of infections.
The study confirms the value of the decolonization strategy, which the World Health Organization has endorsed with the highest level of scientific evidence that is available in preventive strategies in surgery. WHO strongly recommends decolonization for cardiothoracic and orthopedic surgery using intranasal applications of mupirocin 2% ointment with or without a combination of chlorhexidine gluconate body wash. It has a conditional recommendation for a similar procedure before other types of surgery.
However, “It is not widely practiced, and although that was not a surprise to me, I think it’s really disappointing to see that proven effective strategies are not being practiced,” said Dr. Kluytmans, professor of medical microbiology at University Medical Center Utrecht, Utrecht University, the Netherlands. “If I would come into surgery being a carrier, and not be decolonized, I would really be quite angry because it puts you at risk, which is preventable. I think that’s something we owe to our patients,” he said.
He said that some may have concerns about the potential for decolonization to contribute to antibiotic resistance, but the short-term prophylaxis — typically a few days — should not foster resistance, according to Dr. Kluytmans. “If you use it short term, just before surgery, it has been shown in many studies that resistance isn’t a big problem and it can be monitored.”
The link specifically to SA nasal carriage is a mystery, according to Dr. Kluytmans. “It puzzles me still how it gets from the nares to the wound during surgery. So that’s my million-dollar question that I would like to resolve. We would like to study it, but we haven’t quite a bright idea how to do that,” he said.
The results are compelling, according to Heather Evans, MD, who was asked for comment. “On the face of it, this looks like a no-brainer. We should be decolonizing all patients that go to the operating room, and it’s not a terribly unpleasant thing for a patient to undergo to have decolonization done. Particularly for patients who are at higher risk for having a severe complication, like someone that has an operation that’s involving an implant, for example, I think it really makes a lot of sense to do this low-cost intervention for those patients,” said Dr. Evans, professor of medicine at The Medical University of South Carolina as well as the president of the Surgical Infection Society.
She noted that many facilities test for methicillin-resistant SA, but usual not SA more broadly. “This is a very interesting and compelling study that makes us rethink that, and maybe it isn’t even worth testing to see if you have staph aureus, maybe we should just be putting Betadine in everyone’s nostrils when they come to the operating room. It just seems like it would be a pretty low-cost intervention and something that could potentially have a big impact,” said Dr. Evans.
Although she was impressed by the study, Dr. Evans noted that the researchers tested for carriage at sites unrelated to the surgical site. “It really made me wonder if it would have added even more credibility to the study if there had been a sample taken after surgical prep was done to demonstrate that there is actually no staph aureus present on the skin at the time that the wound was made,” she said.
The question ties into the recent “Trojan horse” hypothesis, which suggests that endemic carriage of bacteria is responsible for most surgical site infections, rather than the long-held belief that operating room contamination is to blame. “That would sort of fly with this study, that the patient is walking around with Staph aureus and not necessarily on their skin or at their surgical site, but it’s endemic in their body,” said Dr. Evans.
Dr. Kluytmans and Dr. Evans have no relevant financial disclosures.
published in the August issue of Open Forum Infectious Diseases.
“This was a pan-European study with many hospitals, many different clinical settings, and as far as I’m aware, it hasn’t been done before. [The new study] covers a lot of European countries and a lot of surgical specialties,” said lead author Jan Kluytmans, MD. The study also captures the current state of preventive strategies in surgery, such as changes in air flow, dress, and skin preparation, he added.
The study included 5004 patients from 33 hospitals in ten European countries, of whom 67.3% were found to be SA carriers. The median age was 65 years, and 49.8% of patients were male. Open cardiac, and knee and hip prosthesis surgeries made up the largest fraction, but there were 12 types of surgery included in the study.
There were 100 SA surgical site or blood infections. The researchers found an association between surgical site or blood infection and SA carriage at any site (adjusted hazard ratio [aHR], 4.6; 95% CI, 2.1-10.0) and nasal SA carriage (aHR, 4.2; 95% CI, 2.0-8.6). Extranasal SA carriage was not associated with an increased infection risk.
Each 1-unit increase in nasal bacteria was associated with an increase in infection risk (aHR, 1.23; 95% CI, 1.05-1.43).
A strength of the study is that it is the largest prospective study yet conducted on SA carriage in surgical patients, but the researchers were unable to do a subgroup of methicillin-resistant SA (MRSA) due to small numbers of infections.
The study confirms the value of the decolonization strategy, which the World Health Organization has endorsed with the highest level of scientific evidence that is available in preventive strategies in surgery. WHO strongly recommends decolonization for cardiothoracic and orthopedic surgery using intranasal applications of mupirocin 2% ointment with or without a combination of chlorhexidine gluconate body wash. It has a conditional recommendation for a similar procedure before other types of surgery.
However, “It is not widely practiced, and although that was not a surprise to me, I think it’s really disappointing to see that proven effective strategies are not being practiced,” said Dr. Kluytmans, professor of medical microbiology at University Medical Center Utrecht, Utrecht University, the Netherlands. “If I would come into surgery being a carrier, and not be decolonized, I would really be quite angry because it puts you at risk, which is preventable. I think that’s something we owe to our patients,” he said.
He said that some may have concerns about the potential for decolonization to contribute to antibiotic resistance, but the short-term prophylaxis — typically a few days — should not foster resistance, according to Dr. Kluytmans. “If you use it short term, just before surgery, it has been shown in many studies that resistance isn’t a big problem and it can be monitored.”
The link specifically to SA nasal carriage is a mystery, according to Dr. Kluytmans. “It puzzles me still how it gets from the nares to the wound during surgery. So that’s my million-dollar question that I would like to resolve. We would like to study it, but we haven’t quite a bright idea how to do that,” he said.
The results are compelling, according to Heather Evans, MD, who was asked for comment. “On the face of it, this looks like a no-brainer. We should be decolonizing all patients that go to the operating room, and it’s not a terribly unpleasant thing for a patient to undergo to have decolonization done. Particularly for patients who are at higher risk for having a severe complication, like someone that has an operation that’s involving an implant, for example, I think it really makes a lot of sense to do this low-cost intervention for those patients,” said Dr. Evans, professor of medicine at The Medical University of South Carolina as well as the president of the Surgical Infection Society.
She noted that many facilities test for methicillin-resistant SA, but usual not SA more broadly. “This is a very interesting and compelling study that makes us rethink that, and maybe it isn’t even worth testing to see if you have staph aureus, maybe we should just be putting Betadine in everyone’s nostrils when they come to the operating room. It just seems like it would be a pretty low-cost intervention and something that could potentially have a big impact,” said Dr. Evans.
Although she was impressed by the study, Dr. Evans noted that the researchers tested for carriage at sites unrelated to the surgical site. “It really made me wonder if it would have added even more credibility to the study if there had been a sample taken after surgical prep was done to demonstrate that there is actually no staph aureus present on the skin at the time that the wound was made,” she said.
The question ties into the recent “Trojan horse” hypothesis, which suggests that endemic carriage of bacteria is responsible for most surgical site infections, rather than the long-held belief that operating room contamination is to blame. “That would sort of fly with this study, that the patient is walking around with Staph aureus and not necessarily on their skin or at their surgical site, but it’s endemic in their body,” said Dr. Evans.
Dr. Kluytmans and Dr. Evans have no relevant financial disclosures.