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Don’t Leave CVD Risk in RA Undertreated Despite Unresolved Questions
NEW YORK — Patients with rheumatoid arthritis (RA) carry a high risk for cardiovascular events, but mounting clinical evidence suggests they’re being undertreated to manage that risk. Rheumatologists should consider a patient with RA’s cardiovascular disease (CVD) status before deciding on RA treatments, a researcher of cardiometabolic disorders advised.
“The ORAL Surveillance trial suggests that we need to consider cardiovascular risk factors and maybe do additional screening in these patients before we use RA therapies,” Jon T. Giles, MD, PhD, director of the Cedars-Sinai Inflammatory Arthritis Clinical Center at Cedars-Sinai in Los Angeles, told attendees at the 4th Annual Cardiometabolic Risk in Inflammatory Conditions conference.
Underuse of Statins
ORAL Surveillance enrolled 4362 patients with RA aged 50 years and older with at least one cardiovascular risk factor. About 23% of all patients were taking statins, as were about half of patients with a history of atherosclerotic CVD (ASCVD).
“A lot of those people should have been on statins,” Dr. Giles said in an interview. “Not because of their RA but because of their risk factors, and then RA brings it up another notch.” In the population with ASCVD, Dr. Giles added, “It should have been more like 70% and 80%. If we’re talking about a disease that has enhanced cardiovascular risk, then the adoption of standard care that you would do for anybody in the general population should be at that standard and maybe above.”
Multiple studies have documented the underlying risk for CVD events, CV mortality, and subclinical atherosclerosis in people with RA, Dr. Giles noted in his presentation. Physiologically, the RA-specific risk factors most linked to CVD risk are systemic inflammation/cytokine excess and specific circulating T-cell and intermediate monocyte subsets, or both, Dr. Giles said.
Disease-Modifying Antirheumatic Drugs (DMARDs) and CVD Risk
Likewise, research in the past decade has linked methotrexate and tumor necrosis factor (TNF) inhibitors to reduced ASCVD events in RA. Another study showed that abatacept had an effect similar to that of etanercept in patients with RA, and the ENTRACTE trial, for which Dr. Giles was the lead author, demonstrated that tocilizumab matched etanercept in reducing CV events.
The ORAL Surveillance investigators also reported that patients with RA who were receiving the Janus kinase (JAK) inhibitor tofacitinib had a higher risk for major adverse cardiovascular events and cancers than those on TNF therapy, Dr. Giles noted. While statins in combination with JAK inhibitors may have the potential to provide a balance for controlling CV risk in patients with RA, he said later that the potential of JAK inhibitors in reducing CVD risk in RA “is still unsettled.”
The ongoing TARGET trial is further evaluating the impact of DMARDs on vascular inflammation in RA, said Dr. Giles, who’s also a trial principal investigator. TARGET is randomizing 115 patients with RA who didn’t respond to methotrexate to a TNF inhibitor or the addition of sulfasalazine and hydroxychloroquine to their methotrexate. Patients can be on low-intensity but not high-intensity statin therapy, Dr. Giles said.
TARGET results reported last year demonstrated an 8% decrease in arterial fluorodeoxyglucose (FDG) uptake on PET-CT in both treatment arms. Previous studies, Dr. Giles noted, have shown a potential link between FDG and histologic markers of inflammation. “An 8% decrease in vascular FDG is in line with what you would expect from statin treatment,” he said.
TARGET results published in April showed that a measure of a cluster of 12 cytokines and other inflammatory mediators, known as the multibiomarker disease activity (MBDA) score and marketed under the brand name Vectra DA, may help determine arterial FDG uptake. “Those who had a low MBDA score at week 24 actually had the greatest reduction in the arterial FDG,” he said.
Those results were driven entirely by low serum amyloid A (SAA) levels, Dr. Giles said. Those same results didn’t hold for patients in whom SAA and C-reactive protein were correlated.
“So, there’s more to come here,” Dr. Giles said. “We’re looking at other, much larger biomarker panels.”
Nonetheless, he said, sufficient evidence exists to conclude that treating RA to target reduces CV events. “The idea is that at every visit that you see an RA patient, you measure their disease activity, and if they’re not at the target of low disease activity or remission, then you change their therapy to improve that,” he said in an interview.
But an evidence-based guideline is needed to improve coverage of CVD risks in patients with RA, Dr. Giles said. “There is a movement afoot” for a guideline, he said. “If you just did what is supposed to happen for a general population, you would make some improvements. The risk-benefit [ratio] for statins for people with RA has been looked at, and it’s very favorable.”
Unanswered Questions
Dr. Giles noted that the ORAL Surveillance trial has left a number of questions unanswered about the role of JAK inhibitors in managing CVD risk in patients with RA. “The issue that we’re trying to ask is, is it just the TNF inhibitors may be better? Is this a subpopulation issue, or was it just bad luck from the purposes of this one trial? Granted, it was a very large trial, but you can still have luck in terms of getting an effect that’s not accurate.”
Dr. Giles’ “gut feeling” on JAK inhibitors is that they’re not causing harm, but that they’re not as effective as TNF inhibitors in ameliorating CV risks in patients with RA.
Michael S. Garshick, MD, who attended the conference and is head of the cardio-rheumatology program at NYU Langone Health, concurred that a number of unanswered questions persist over the treatment of CVD risk in RA — and autoimmune disease in general.
“I think we’re still trying to prove that DMARDs reduce cardiovascular risk in autoimmune conditions,” he said. “The epidemiologic data would suggest, yes, that inflammation prevention is beneficial for cardiovascular disease, but the TARGET trial suggested that vascular inflammation improved by treating RA, but that biologic therapy wasn’t better than traditional triple therapy.”
Other questions remain unanswered, Dr. Garshick said.
“Is there a specific immunotherapy that is most beneficial to reduce heart disease in patients with an autoimmune condition, whether it’s rheumatoid arthritis, psoriasis, or lupus?”
Dr. Garshick said he’s specifically interested in the residual risk that exists after treating the autoimmunity. “Do you still have a higher risk for heart disease, and if so, why? Is there something else going on that we can’t see?”
The biggest unanswered question, he said, is “How can we do a better job of recognizing heart disease risk in these patients? That’s the low-hanging fruit that people are studying, but across many of those studies, patients have higher rates of blood pressure, cholesterol issues, obesity, diabetes, and many times, we’re not adequately treating these comorbidities.”
That, Dr. Garshick said, may be a result of physician fatigue. “And so [treatment of these comorbidities is] kicked down the road for a year or years,” he added.
Dr. Giles disclosed financial relationships with Pfizer, AbbVie, Eli Lilly, and Novartis. Dr. Garshick disclosed relationships with Kiniksa Pharmaceuticals, Agepha Pharma, Bristol Myers Squibb, and Horizon Therapeutics.
A version of this article appeared on Medscape.com.
NEW YORK — Patients with rheumatoid arthritis (RA) carry a high risk for cardiovascular events, but mounting clinical evidence suggests they’re being undertreated to manage that risk. Rheumatologists should consider a patient with RA’s cardiovascular disease (CVD) status before deciding on RA treatments, a researcher of cardiometabolic disorders advised.
“The ORAL Surveillance trial suggests that we need to consider cardiovascular risk factors and maybe do additional screening in these patients before we use RA therapies,” Jon T. Giles, MD, PhD, director of the Cedars-Sinai Inflammatory Arthritis Clinical Center at Cedars-Sinai in Los Angeles, told attendees at the 4th Annual Cardiometabolic Risk in Inflammatory Conditions conference.
Underuse of Statins
ORAL Surveillance enrolled 4362 patients with RA aged 50 years and older with at least one cardiovascular risk factor. About 23% of all patients were taking statins, as were about half of patients with a history of atherosclerotic CVD (ASCVD).
“A lot of those people should have been on statins,” Dr. Giles said in an interview. “Not because of their RA but because of their risk factors, and then RA brings it up another notch.” In the population with ASCVD, Dr. Giles added, “It should have been more like 70% and 80%. If we’re talking about a disease that has enhanced cardiovascular risk, then the adoption of standard care that you would do for anybody in the general population should be at that standard and maybe above.”
Multiple studies have documented the underlying risk for CVD events, CV mortality, and subclinical atherosclerosis in people with RA, Dr. Giles noted in his presentation. Physiologically, the RA-specific risk factors most linked to CVD risk are systemic inflammation/cytokine excess and specific circulating T-cell and intermediate monocyte subsets, or both, Dr. Giles said.
Disease-Modifying Antirheumatic Drugs (DMARDs) and CVD Risk
Likewise, research in the past decade has linked methotrexate and tumor necrosis factor (TNF) inhibitors to reduced ASCVD events in RA. Another study showed that abatacept had an effect similar to that of etanercept in patients with RA, and the ENTRACTE trial, for which Dr. Giles was the lead author, demonstrated that tocilizumab matched etanercept in reducing CV events.
The ORAL Surveillance investigators also reported that patients with RA who were receiving the Janus kinase (JAK) inhibitor tofacitinib had a higher risk for major adverse cardiovascular events and cancers than those on TNF therapy, Dr. Giles noted. While statins in combination with JAK inhibitors may have the potential to provide a balance for controlling CV risk in patients with RA, he said later that the potential of JAK inhibitors in reducing CVD risk in RA “is still unsettled.”
The ongoing TARGET trial is further evaluating the impact of DMARDs on vascular inflammation in RA, said Dr. Giles, who’s also a trial principal investigator. TARGET is randomizing 115 patients with RA who didn’t respond to methotrexate to a TNF inhibitor or the addition of sulfasalazine and hydroxychloroquine to their methotrexate. Patients can be on low-intensity but not high-intensity statin therapy, Dr. Giles said.
TARGET results reported last year demonstrated an 8% decrease in arterial fluorodeoxyglucose (FDG) uptake on PET-CT in both treatment arms. Previous studies, Dr. Giles noted, have shown a potential link between FDG and histologic markers of inflammation. “An 8% decrease in vascular FDG is in line with what you would expect from statin treatment,” he said.
TARGET results published in April showed that a measure of a cluster of 12 cytokines and other inflammatory mediators, known as the multibiomarker disease activity (MBDA) score and marketed under the brand name Vectra DA, may help determine arterial FDG uptake. “Those who had a low MBDA score at week 24 actually had the greatest reduction in the arterial FDG,” he said.
Those results were driven entirely by low serum amyloid A (SAA) levels, Dr. Giles said. Those same results didn’t hold for patients in whom SAA and C-reactive protein were correlated.
“So, there’s more to come here,” Dr. Giles said. “We’re looking at other, much larger biomarker panels.”
Nonetheless, he said, sufficient evidence exists to conclude that treating RA to target reduces CV events. “The idea is that at every visit that you see an RA patient, you measure their disease activity, and if they’re not at the target of low disease activity or remission, then you change their therapy to improve that,” he said in an interview.
But an evidence-based guideline is needed to improve coverage of CVD risks in patients with RA, Dr. Giles said. “There is a movement afoot” for a guideline, he said. “If you just did what is supposed to happen for a general population, you would make some improvements. The risk-benefit [ratio] for statins for people with RA has been looked at, and it’s very favorable.”
Unanswered Questions
Dr. Giles noted that the ORAL Surveillance trial has left a number of questions unanswered about the role of JAK inhibitors in managing CVD risk in patients with RA. “The issue that we’re trying to ask is, is it just the TNF inhibitors may be better? Is this a subpopulation issue, or was it just bad luck from the purposes of this one trial? Granted, it was a very large trial, but you can still have luck in terms of getting an effect that’s not accurate.”
Dr. Giles’ “gut feeling” on JAK inhibitors is that they’re not causing harm, but that they’re not as effective as TNF inhibitors in ameliorating CV risks in patients with RA.
Michael S. Garshick, MD, who attended the conference and is head of the cardio-rheumatology program at NYU Langone Health, concurred that a number of unanswered questions persist over the treatment of CVD risk in RA — and autoimmune disease in general.
“I think we’re still trying to prove that DMARDs reduce cardiovascular risk in autoimmune conditions,” he said. “The epidemiologic data would suggest, yes, that inflammation prevention is beneficial for cardiovascular disease, but the TARGET trial suggested that vascular inflammation improved by treating RA, but that biologic therapy wasn’t better than traditional triple therapy.”
Other questions remain unanswered, Dr. Garshick said.
“Is there a specific immunotherapy that is most beneficial to reduce heart disease in patients with an autoimmune condition, whether it’s rheumatoid arthritis, psoriasis, or lupus?”
Dr. Garshick said he’s specifically interested in the residual risk that exists after treating the autoimmunity. “Do you still have a higher risk for heart disease, and if so, why? Is there something else going on that we can’t see?”
The biggest unanswered question, he said, is “How can we do a better job of recognizing heart disease risk in these patients? That’s the low-hanging fruit that people are studying, but across many of those studies, patients have higher rates of blood pressure, cholesterol issues, obesity, diabetes, and many times, we’re not adequately treating these comorbidities.”
That, Dr. Garshick said, may be a result of physician fatigue. “And so [treatment of these comorbidities is] kicked down the road for a year or years,” he added.
Dr. Giles disclosed financial relationships with Pfizer, AbbVie, Eli Lilly, and Novartis. Dr. Garshick disclosed relationships with Kiniksa Pharmaceuticals, Agepha Pharma, Bristol Myers Squibb, and Horizon Therapeutics.
A version of this article appeared on Medscape.com.
NEW YORK — Patients with rheumatoid arthritis (RA) carry a high risk for cardiovascular events, but mounting clinical evidence suggests they’re being undertreated to manage that risk. Rheumatologists should consider a patient with RA’s cardiovascular disease (CVD) status before deciding on RA treatments, a researcher of cardiometabolic disorders advised.
“The ORAL Surveillance trial suggests that we need to consider cardiovascular risk factors and maybe do additional screening in these patients before we use RA therapies,” Jon T. Giles, MD, PhD, director of the Cedars-Sinai Inflammatory Arthritis Clinical Center at Cedars-Sinai in Los Angeles, told attendees at the 4th Annual Cardiometabolic Risk in Inflammatory Conditions conference.
Underuse of Statins
ORAL Surveillance enrolled 4362 patients with RA aged 50 years and older with at least one cardiovascular risk factor. About 23% of all patients were taking statins, as were about half of patients with a history of atherosclerotic CVD (ASCVD).
“A lot of those people should have been on statins,” Dr. Giles said in an interview. “Not because of their RA but because of their risk factors, and then RA brings it up another notch.” In the population with ASCVD, Dr. Giles added, “It should have been more like 70% and 80%. If we’re talking about a disease that has enhanced cardiovascular risk, then the adoption of standard care that you would do for anybody in the general population should be at that standard and maybe above.”
Multiple studies have documented the underlying risk for CVD events, CV mortality, and subclinical atherosclerosis in people with RA, Dr. Giles noted in his presentation. Physiologically, the RA-specific risk factors most linked to CVD risk are systemic inflammation/cytokine excess and specific circulating T-cell and intermediate monocyte subsets, or both, Dr. Giles said.
Disease-Modifying Antirheumatic Drugs (DMARDs) and CVD Risk
Likewise, research in the past decade has linked methotrexate and tumor necrosis factor (TNF) inhibitors to reduced ASCVD events in RA. Another study showed that abatacept had an effect similar to that of etanercept in patients with RA, and the ENTRACTE trial, for which Dr. Giles was the lead author, demonstrated that tocilizumab matched etanercept in reducing CV events.
The ORAL Surveillance investigators also reported that patients with RA who were receiving the Janus kinase (JAK) inhibitor tofacitinib had a higher risk for major adverse cardiovascular events and cancers than those on TNF therapy, Dr. Giles noted. While statins in combination with JAK inhibitors may have the potential to provide a balance for controlling CV risk in patients with RA, he said later that the potential of JAK inhibitors in reducing CVD risk in RA “is still unsettled.”
The ongoing TARGET trial is further evaluating the impact of DMARDs on vascular inflammation in RA, said Dr. Giles, who’s also a trial principal investigator. TARGET is randomizing 115 patients with RA who didn’t respond to methotrexate to a TNF inhibitor or the addition of sulfasalazine and hydroxychloroquine to their methotrexate. Patients can be on low-intensity but not high-intensity statin therapy, Dr. Giles said.
TARGET results reported last year demonstrated an 8% decrease in arterial fluorodeoxyglucose (FDG) uptake on PET-CT in both treatment arms. Previous studies, Dr. Giles noted, have shown a potential link between FDG and histologic markers of inflammation. “An 8% decrease in vascular FDG is in line with what you would expect from statin treatment,” he said.
TARGET results published in April showed that a measure of a cluster of 12 cytokines and other inflammatory mediators, known as the multibiomarker disease activity (MBDA) score and marketed under the brand name Vectra DA, may help determine arterial FDG uptake. “Those who had a low MBDA score at week 24 actually had the greatest reduction in the arterial FDG,” he said.
Those results were driven entirely by low serum amyloid A (SAA) levels, Dr. Giles said. Those same results didn’t hold for patients in whom SAA and C-reactive protein were correlated.
“So, there’s more to come here,” Dr. Giles said. “We’re looking at other, much larger biomarker panels.”
Nonetheless, he said, sufficient evidence exists to conclude that treating RA to target reduces CV events. “The idea is that at every visit that you see an RA patient, you measure their disease activity, and if they’re not at the target of low disease activity or remission, then you change their therapy to improve that,” he said in an interview.
But an evidence-based guideline is needed to improve coverage of CVD risks in patients with RA, Dr. Giles said. “There is a movement afoot” for a guideline, he said. “If you just did what is supposed to happen for a general population, you would make some improvements. The risk-benefit [ratio] for statins for people with RA has been looked at, and it’s very favorable.”
Unanswered Questions
Dr. Giles noted that the ORAL Surveillance trial has left a number of questions unanswered about the role of JAK inhibitors in managing CVD risk in patients with RA. “The issue that we’re trying to ask is, is it just the TNF inhibitors may be better? Is this a subpopulation issue, or was it just bad luck from the purposes of this one trial? Granted, it was a very large trial, but you can still have luck in terms of getting an effect that’s not accurate.”
Dr. Giles’ “gut feeling” on JAK inhibitors is that they’re not causing harm, but that they’re not as effective as TNF inhibitors in ameliorating CV risks in patients with RA.
Michael S. Garshick, MD, who attended the conference and is head of the cardio-rheumatology program at NYU Langone Health, concurred that a number of unanswered questions persist over the treatment of CVD risk in RA — and autoimmune disease in general.
“I think we’re still trying to prove that DMARDs reduce cardiovascular risk in autoimmune conditions,” he said. “The epidemiologic data would suggest, yes, that inflammation prevention is beneficial for cardiovascular disease, but the TARGET trial suggested that vascular inflammation improved by treating RA, but that biologic therapy wasn’t better than traditional triple therapy.”
Other questions remain unanswered, Dr. Garshick said.
“Is there a specific immunotherapy that is most beneficial to reduce heart disease in patients with an autoimmune condition, whether it’s rheumatoid arthritis, psoriasis, or lupus?”
Dr. Garshick said he’s specifically interested in the residual risk that exists after treating the autoimmunity. “Do you still have a higher risk for heart disease, and if so, why? Is there something else going on that we can’t see?”
The biggest unanswered question, he said, is “How can we do a better job of recognizing heart disease risk in these patients? That’s the low-hanging fruit that people are studying, but across many of those studies, patients have higher rates of blood pressure, cholesterol issues, obesity, diabetes, and many times, we’re not adequately treating these comorbidities.”
That, Dr. Garshick said, may be a result of physician fatigue. “And so [treatment of these comorbidities is] kicked down the road for a year or years,” he added.
Dr. Giles disclosed financial relationships with Pfizer, AbbVie, Eli Lilly, and Novartis. Dr. Garshick disclosed relationships with Kiniksa Pharmaceuticals, Agepha Pharma, Bristol Myers Squibb, and Horizon Therapeutics.
A version of this article appeared on Medscape.com.
Why Incorporating Obstetric History Matters for CVD Risk Management in Autoimmune Diseases
NEW YORK — Systemic autoimmune disease is well-recognized as a major risk factor for cardiovascular disease (CVD), but less recognized as a cardiovascular risk factor is a history of pregnancy complications, including preeclampsia, and cardiologists and rheumatologists need to include an obstetric history when managing patients with autoimmune diseases, a specialist in reproductive health in rheumatology told attendees at the 4th Annual Cardiometabolic Risk in Inflammatory Conditions conference.
“Autoimmune diseases, lupus in particular, increase the risk for both cardiovascular disease and maternal placental syndromes,” Lisa R. Sammaritano, MD, a professor at Hospital for Special Surgery in New York City and a specialist in reproductive health issues in rheumatology patients, told attendees. “For those patients who have complications during pregnancy, it further increases their already increased risk for later cardiovascular disease.”
CVD Risk Double Whammy
A history of systemic lupus erythematosus (SLE) and problematic pregnancy can be a double whammy for CVD risk. Dr. Sammaritano cited a 2022 meta-analysis that showed patients with SLE had a 2.5 times greater risk for stroke and almost three times greater risk for myocardial infarction than people without SLE.
Maternal placental syndromes include pregnancy loss, restricted fetal growth, preeclampsia, premature membrane rupture, placental abruption, and intrauterine fetal demise, Dr. Sammaritano said. Hypertensive disorders of pregnancy, formerly called adverse pregnancy outcomes, she noted, include gestational hypertension, preeclampsia, and eclampsia.
Pregnancy complications can have an adverse effect on the mother’s postpartum cardiovascular health, Dr. Sammaritano noted, a fact borne out by the cardiovascular health after maternal placental syndromes population-based retrospective cohort study and a 2007 meta-analysis that found a history of preeclampsia doubles the risk for venous thromboembolism, stroke, and ischemic heart disease up to 15 years after pregnancy.
“It is always important to obtain a reproductive health history from patients with autoimmune diseases,” Dr. Sammaritano told this news organization in an interview. “This is an integral part of any medical history. In the usual setting, this includes not only pregnancy history but also use of contraception in reproductive-aged women. Unplanned pregnancy can lead to adverse outcomes in the setting of active or severe autoimmune disease or when teratogenic medications are used.”
Pregnancy history can be a factor in a woman’s cardiovascular health more than 15 years postpartum, even if a woman is no longer planning a pregnancy or is menopausal. “As such, this history is important in assessing every woman’s risk profile for CVD in addition to usual traditional risk factors,” Dr. Sammaritano said.
“It is even more important for women with autoimmune disorders, who have been shown to have an already increased risk for CVD independent of their pregnancy history, likely related to a chronic inflammatory state and other autoimmune-related factors such as presence of antiphospholipid antibodies [aPL] or use of corticosteroids.”
Timing of disease onset is also an issue, she said. “In patients with SLE, for example, onset of CVD is much earlier than in the general population,” Dr. Sammaritano said. “As a result, these patients should likely be assessed for risk — both traditional and other risk factors — earlier than the general population, especially if an adverse obstetric history is present.”
At the younger end of the age continuum, women with autoimmune disease, including SLE and antiphospholipid syndrome, who are pregnant should be put on guideline-directed low-dose aspirin preeclampsia prophylaxis, Dr. Sammaritano said. “Whether every patient with SLE needs this is still uncertain, but certainly, those with a history of renal disease, hypertension, or aPL antibody clearly do,” she added.
The evidence supporting hydroxychloroquine (HCQ) in these patients is controversial, but Dr. Sammaritano noted two meta-analyses, one in 2022 and the other in 2023, that showed that HCQ lowered the risk for preeclampsia in women.
“The clear benefit of HCQ in preventing maternal disease complications, including flare, means we recommend it regardless for all patients with SLE at baseline and during pregnancy [if tolerated],” Dr. Sammaritano said. “The benefit or optimal use of these medications in other autoimmune diseases is less studied and less certain.”
Dr. Sammaritano added in her presentation, “We really need better therapies and, hopefully, those will be on the way, but I think the takeaway message, particularly for practicing rheumatologists and cardiologists, is to ask the question about obstetric history. Many of us don’t. It doesn’t seem relevant in the moment, but it really is in terms of the patient’s long-term risk for cardiovascular disease.”
The Case for Treatment During Pregnancy
Prophylaxis against pregnancy complications in patients with autoimmune disease may be achievable, Taryn Youngstein, MBBS, consultant rheumatologist and codirector of the Centre of Excellence in Vasculitis Research, Imperial College London, London, England, told this news organization after Dr. Sammaritano’s presentation. At the 2023 American College of Rheumatology Annual Meeting, her group reported the safety and effectiveness of continuing tocilizumab in pregnant women with Takayasu arteritis, a large-vessel vasculitis predominantly affecting women of reproductive age.
“What traditionally happens is you would stop the biologic particularly before the third trimester because of safety and concerns that the monoclonal antibody is actively transported across the placenta, which means the baby gets much more concentration of the drug than the mum,” Dr. Youngstein said.
It’s a situation physicians must monitor closely, she said. “The mum is donating their immune system to the baby, but they’re also donating drug.”
“In high-risk patients, we would share decision-making with the patient,” Dr. Youngstein continued. “We have decided it’s too high of a risk for us to stop the drug, so we have been continuing the interleukin-6 [IL-6] inhibitor throughout the entire pregnancy.”
The data from Dr. Youngstein’s group showed that pregnant women with Takayasu arteritis who continued IL-6 inhibition therapy all carried to term with healthy births.
“We’ve shown that it’s relatively safe to do that, but you have to be very careful in monitoring the baby,” she said. This includes not giving the infant any live vaccines at birth because it will have the high levels of IL-6 inhibition, she said.
Dr. Sammaritano and Dr. Youngstein had no relevant financial relationships to disclose.
A version of this article appeared on Medscape.com.
NEW YORK — Systemic autoimmune disease is well-recognized as a major risk factor for cardiovascular disease (CVD), but less recognized as a cardiovascular risk factor is a history of pregnancy complications, including preeclampsia, and cardiologists and rheumatologists need to include an obstetric history when managing patients with autoimmune diseases, a specialist in reproductive health in rheumatology told attendees at the 4th Annual Cardiometabolic Risk in Inflammatory Conditions conference.
“Autoimmune diseases, lupus in particular, increase the risk for both cardiovascular disease and maternal placental syndromes,” Lisa R. Sammaritano, MD, a professor at Hospital for Special Surgery in New York City and a specialist in reproductive health issues in rheumatology patients, told attendees. “For those patients who have complications during pregnancy, it further increases their already increased risk for later cardiovascular disease.”
CVD Risk Double Whammy
A history of systemic lupus erythematosus (SLE) and problematic pregnancy can be a double whammy for CVD risk. Dr. Sammaritano cited a 2022 meta-analysis that showed patients with SLE had a 2.5 times greater risk for stroke and almost three times greater risk for myocardial infarction than people without SLE.
Maternal placental syndromes include pregnancy loss, restricted fetal growth, preeclampsia, premature membrane rupture, placental abruption, and intrauterine fetal demise, Dr. Sammaritano said. Hypertensive disorders of pregnancy, formerly called adverse pregnancy outcomes, she noted, include gestational hypertension, preeclampsia, and eclampsia.
Pregnancy complications can have an adverse effect on the mother’s postpartum cardiovascular health, Dr. Sammaritano noted, a fact borne out by the cardiovascular health after maternal placental syndromes population-based retrospective cohort study and a 2007 meta-analysis that found a history of preeclampsia doubles the risk for venous thromboembolism, stroke, and ischemic heart disease up to 15 years after pregnancy.
“It is always important to obtain a reproductive health history from patients with autoimmune diseases,” Dr. Sammaritano told this news organization in an interview. “This is an integral part of any medical history. In the usual setting, this includes not only pregnancy history but also use of contraception in reproductive-aged women. Unplanned pregnancy can lead to adverse outcomes in the setting of active or severe autoimmune disease or when teratogenic medications are used.”
Pregnancy history can be a factor in a woman’s cardiovascular health more than 15 years postpartum, even if a woman is no longer planning a pregnancy or is menopausal. “As such, this history is important in assessing every woman’s risk profile for CVD in addition to usual traditional risk factors,” Dr. Sammaritano said.
“It is even more important for women with autoimmune disorders, who have been shown to have an already increased risk for CVD independent of their pregnancy history, likely related to a chronic inflammatory state and other autoimmune-related factors such as presence of antiphospholipid antibodies [aPL] or use of corticosteroids.”
Timing of disease onset is also an issue, she said. “In patients with SLE, for example, onset of CVD is much earlier than in the general population,” Dr. Sammaritano said. “As a result, these patients should likely be assessed for risk — both traditional and other risk factors — earlier than the general population, especially if an adverse obstetric history is present.”
At the younger end of the age continuum, women with autoimmune disease, including SLE and antiphospholipid syndrome, who are pregnant should be put on guideline-directed low-dose aspirin preeclampsia prophylaxis, Dr. Sammaritano said. “Whether every patient with SLE needs this is still uncertain, but certainly, those with a history of renal disease, hypertension, or aPL antibody clearly do,” she added.
The evidence supporting hydroxychloroquine (HCQ) in these patients is controversial, but Dr. Sammaritano noted two meta-analyses, one in 2022 and the other in 2023, that showed that HCQ lowered the risk for preeclampsia in women.
“The clear benefit of HCQ in preventing maternal disease complications, including flare, means we recommend it regardless for all patients with SLE at baseline and during pregnancy [if tolerated],” Dr. Sammaritano said. “The benefit or optimal use of these medications in other autoimmune diseases is less studied and less certain.”
Dr. Sammaritano added in her presentation, “We really need better therapies and, hopefully, those will be on the way, but I think the takeaway message, particularly for practicing rheumatologists and cardiologists, is to ask the question about obstetric history. Many of us don’t. It doesn’t seem relevant in the moment, but it really is in terms of the patient’s long-term risk for cardiovascular disease.”
The Case for Treatment During Pregnancy
Prophylaxis against pregnancy complications in patients with autoimmune disease may be achievable, Taryn Youngstein, MBBS, consultant rheumatologist and codirector of the Centre of Excellence in Vasculitis Research, Imperial College London, London, England, told this news organization after Dr. Sammaritano’s presentation. At the 2023 American College of Rheumatology Annual Meeting, her group reported the safety and effectiveness of continuing tocilizumab in pregnant women with Takayasu arteritis, a large-vessel vasculitis predominantly affecting women of reproductive age.
“What traditionally happens is you would stop the biologic particularly before the third trimester because of safety and concerns that the monoclonal antibody is actively transported across the placenta, which means the baby gets much more concentration of the drug than the mum,” Dr. Youngstein said.
It’s a situation physicians must monitor closely, she said. “The mum is donating their immune system to the baby, but they’re also donating drug.”
“In high-risk patients, we would share decision-making with the patient,” Dr. Youngstein continued. “We have decided it’s too high of a risk for us to stop the drug, so we have been continuing the interleukin-6 [IL-6] inhibitor throughout the entire pregnancy.”
The data from Dr. Youngstein’s group showed that pregnant women with Takayasu arteritis who continued IL-6 inhibition therapy all carried to term with healthy births.
“We’ve shown that it’s relatively safe to do that, but you have to be very careful in monitoring the baby,” she said. This includes not giving the infant any live vaccines at birth because it will have the high levels of IL-6 inhibition, she said.
Dr. Sammaritano and Dr. Youngstein had no relevant financial relationships to disclose.
A version of this article appeared on Medscape.com.
NEW YORK — Systemic autoimmune disease is well-recognized as a major risk factor for cardiovascular disease (CVD), but less recognized as a cardiovascular risk factor is a history of pregnancy complications, including preeclampsia, and cardiologists and rheumatologists need to include an obstetric history when managing patients with autoimmune diseases, a specialist in reproductive health in rheumatology told attendees at the 4th Annual Cardiometabolic Risk in Inflammatory Conditions conference.
“Autoimmune diseases, lupus in particular, increase the risk for both cardiovascular disease and maternal placental syndromes,” Lisa R. Sammaritano, MD, a professor at Hospital for Special Surgery in New York City and a specialist in reproductive health issues in rheumatology patients, told attendees. “For those patients who have complications during pregnancy, it further increases their already increased risk for later cardiovascular disease.”
CVD Risk Double Whammy
A history of systemic lupus erythematosus (SLE) and problematic pregnancy can be a double whammy for CVD risk. Dr. Sammaritano cited a 2022 meta-analysis that showed patients with SLE had a 2.5 times greater risk for stroke and almost three times greater risk for myocardial infarction than people without SLE.
Maternal placental syndromes include pregnancy loss, restricted fetal growth, preeclampsia, premature membrane rupture, placental abruption, and intrauterine fetal demise, Dr. Sammaritano said. Hypertensive disorders of pregnancy, formerly called adverse pregnancy outcomes, she noted, include gestational hypertension, preeclampsia, and eclampsia.
Pregnancy complications can have an adverse effect on the mother’s postpartum cardiovascular health, Dr. Sammaritano noted, a fact borne out by the cardiovascular health after maternal placental syndromes population-based retrospective cohort study and a 2007 meta-analysis that found a history of preeclampsia doubles the risk for venous thromboembolism, stroke, and ischemic heart disease up to 15 years after pregnancy.
“It is always important to obtain a reproductive health history from patients with autoimmune diseases,” Dr. Sammaritano told this news organization in an interview. “This is an integral part of any medical history. In the usual setting, this includes not only pregnancy history but also use of contraception in reproductive-aged women. Unplanned pregnancy can lead to adverse outcomes in the setting of active or severe autoimmune disease or when teratogenic medications are used.”
Pregnancy history can be a factor in a woman’s cardiovascular health more than 15 years postpartum, even if a woman is no longer planning a pregnancy or is menopausal. “As such, this history is important in assessing every woman’s risk profile for CVD in addition to usual traditional risk factors,” Dr. Sammaritano said.
“It is even more important for women with autoimmune disorders, who have been shown to have an already increased risk for CVD independent of their pregnancy history, likely related to a chronic inflammatory state and other autoimmune-related factors such as presence of antiphospholipid antibodies [aPL] or use of corticosteroids.”
Timing of disease onset is also an issue, she said. “In patients with SLE, for example, onset of CVD is much earlier than in the general population,” Dr. Sammaritano said. “As a result, these patients should likely be assessed for risk — both traditional and other risk factors — earlier than the general population, especially if an adverse obstetric history is present.”
At the younger end of the age continuum, women with autoimmune disease, including SLE and antiphospholipid syndrome, who are pregnant should be put on guideline-directed low-dose aspirin preeclampsia prophylaxis, Dr. Sammaritano said. “Whether every patient with SLE needs this is still uncertain, but certainly, those with a history of renal disease, hypertension, or aPL antibody clearly do,” she added.
The evidence supporting hydroxychloroquine (HCQ) in these patients is controversial, but Dr. Sammaritano noted two meta-analyses, one in 2022 and the other in 2023, that showed that HCQ lowered the risk for preeclampsia in women.
“The clear benefit of HCQ in preventing maternal disease complications, including flare, means we recommend it regardless for all patients with SLE at baseline and during pregnancy [if tolerated],” Dr. Sammaritano said. “The benefit or optimal use of these medications in other autoimmune diseases is less studied and less certain.”
Dr. Sammaritano added in her presentation, “We really need better therapies and, hopefully, those will be on the way, but I think the takeaway message, particularly for practicing rheumatologists and cardiologists, is to ask the question about obstetric history. Many of us don’t. It doesn’t seem relevant in the moment, but it really is in terms of the patient’s long-term risk for cardiovascular disease.”
The Case for Treatment During Pregnancy
Prophylaxis against pregnancy complications in patients with autoimmune disease may be achievable, Taryn Youngstein, MBBS, consultant rheumatologist and codirector of the Centre of Excellence in Vasculitis Research, Imperial College London, London, England, told this news organization after Dr. Sammaritano’s presentation. At the 2023 American College of Rheumatology Annual Meeting, her group reported the safety and effectiveness of continuing tocilizumab in pregnant women with Takayasu arteritis, a large-vessel vasculitis predominantly affecting women of reproductive age.
“What traditionally happens is you would stop the biologic particularly before the third trimester because of safety and concerns that the monoclonal antibody is actively transported across the placenta, which means the baby gets much more concentration of the drug than the mum,” Dr. Youngstein said.
It’s a situation physicians must monitor closely, she said. “The mum is donating their immune system to the baby, but they’re also donating drug.”
“In high-risk patients, we would share decision-making with the patient,” Dr. Youngstein continued. “We have decided it’s too high of a risk for us to stop the drug, so we have been continuing the interleukin-6 [IL-6] inhibitor throughout the entire pregnancy.”
The data from Dr. Youngstein’s group showed that pregnant women with Takayasu arteritis who continued IL-6 inhibition therapy all carried to term with healthy births.
“We’ve shown that it’s relatively safe to do that, but you have to be very careful in monitoring the baby,” she said. This includes not giving the infant any live vaccines at birth because it will have the high levels of IL-6 inhibition, she said.
Dr. Sammaritano and Dr. Youngstein had no relevant financial relationships to disclose.
A version of this article appeared on Medscape.com.
Satisfactory Results, Less Pain When Surface Anesthesia Used with Thermomechanical Fractional Injury Therapy
BALTIMORE — , a small study of the recently cleared device found.
The study enrolled 12 patients who were undergoing treatment for periorbital rhytides, or wrinkles, around the eyes. Seven of them received topical anesthetic cream 20 minutes before the procedure, while five were given ice packs to self-apply for 5 minutes beforehand. Patients received four treatment sessions with a month between sessions and were then evaluated up to 3 months after their last session. Study results were presented at the annual conference of the American Society for Laser Medicine and Surgery.
“Based on the approach that we had used, which was to keep the device parameters the same for those who received topical anesthetics and those who received ice, when we looked at the pain levels that the patients had relayed to us when we were doing the procedure, we found that both of them were almost exactly the same in terms of discomfort, a level of 3-4 out of 10, with 10 being the highest discomfort level,” lead investigator Jerome M. Garden, MD, said in an interview after the conference.
“In terms of patient satisfaction using a range of 0-5, again it was fairly equivalent” between the two groups, said Dr. Garden, professor of clinical dermatology and biomedical engineering at Northwestern University, Chicago. “And the overall satisfaction rate was high.”
The same device settings were used for all procedures: A pulse duration of 10 milliseconds and a protrusion depth of 400 micrometers. Double passes were applied using the standard device tip, with the smaller tip used in tighter areas, Dr. Garden said. Three patients were Fitzpatrick skin type (FST) I, six were FST II, and three were FST III.
Study Results
The results for the different anesthetic methods were almost identical. Those using ice reported a 0-10 average pain level of 3.95 ± 1.5, while those who received the topical anesthetic reported a pain level of 3.92 ± 1.5. In terms of self-graded improvement at 3-month follow-up, using a scale of 1-4, with 1 representing up to a 25% improvement and 4 a 75%-100% improvement, the patients using ice had a 2.6 ± 0.5 improvement and those using topical cream a 2.8 ± 0.5 improvement, Dr. Garden said during his presentation.
In terms of patient satisfaction, rated on a scale of 1-5, with 5 being very satisfied, the average grade was 3.9 ± 0.9, Dr. Garden added, with 70% rating ≥ 4.
“This is a relatively new device, which uses an approach to help texture changes in wrinkling on the skin in a different fashion than any of the other devices that are currently out there,” Dr. Garden told this news organization after the conference. “I wanted to understand more in depth the different parameters that may impact the outcome” with this device, he added.
The thermomechanical fractional injury device, originally cleared by the US Food and Drug Administration (FDA) in 2021, with a second-generation device cleared in June 2023, deposits heat into the skin, producing controlled thermal injury to promote collagen and elastin production. The device uses only heat, not a laser, which penetrates the skin. A heat sensation on the skin during the procedure can affect patients differently depending on their level of tolerance, Dr. Garden said during his presentation.
Managing Patient Discomfort
Kachiu C. Lee, MD, MPH, of the Main Line Center for Laser Surgery in Ardmore, Pennsylvania, has used the device in her own practice and found that “it can definitely get a little bit uncomfortable for patients,” she said in an interview after the conference.
“I would say that as the doctor, my number one priority is to always make sure my patients are comfortable, especially when treating a sensitive area like the eyes,” added Dr. Lee, who was not involved with the study. “I don’t want them to suddenly jump or move from the discomfort when I have a device right next to their eye. I think that the patient comfort is very important to make sure that we’re managing their discomfort so that the procedure is tolerable.”
She added, “Dr. Garden’s study was effective at showing that surface anesthesia, whether it be with an ice pack 5 minutes before or a topical numbing cream, can be very effective in reducing the pain level while also not interfering with the efficacy of the treatment itself.”
Dr. Garden serves on the medical advisory board for Novoxel, maker of the device. Dr. Lee had no relevant disclosures.
A version of this article appeared on Medscape.com.
BALTIMORE — , a small study of the recently cleared device found.
The study enrolled 12 patients who were undergoing treatment for periorbital rhytides, or wrinkles, around the eyes. Seven of them received topical anesthetic cream 20 minutes before the procedure, while five were given ice packs to self-apply for 5 minutes beforehand. Patients received four treatment sessions with a month between sessions and were then evaluated up to 3 months after their last session. Study results were presented at the annual conference of the American Society for Laser Medicine and Surgery.
“Based on the approach that we had used, which was to keep the device parameters the same for those who received topical anesthetics and those who received ice, when we looked at the pain levels that the patients had relayed to us when we were doing the procedure, we found that both of them were almost exactly the same in terms of discomfort, a level of 3-4 out of 10, with 10 being the highest discomfort level,” lead investigator Jerome M. Garden, MD, said in an interview after the conference.
“In terms of patient satisfaction using a range of 0-5, again it was fairly equivalent” between the two groups, said Dr. Garden, professor of clinical dermatology and biomedical engineering at Northwestern University, Chicago. “And the overall satisfaction rate was high.”
The same device settings were used for all procedures: A pulse duration of 10 milliseconds and a protrusion depth of 400 micrometers. Double passes were applied using the standard device tip, with the smaller tip used in tighter areas, Dr. Garden said. Three patients were Fitzpatrick skin type (FST) I, six were FST II, and three were FST III.
Study Results
The results for the different anesthetic methods were almost identical. Those using ice reported a 0-10 average pain level of 3.95 ± 1.5, while those who received the topical anesthetic reported a pain level of 3.92 ± 1.5. In terms of self-graded improvement at 3-month follow-up, using a scale of 1-4, with 1 representing up to a 25% improvement and 4 a 75%-100% improvement, the patients using ice had a 2.6 ± 0.5 improvement and those using topical cream a 2.8 ± 0.5 improvement, Dr. Garden said during his presentation.
In terms of patient satisfaction, rated on a scale of 1-5, with 5 being very satisfied, the average grade was 3.9 ± 0.9, Dr. Garden added, with 70% rating ≥ 4.
“This is a relatively new device, which uses an approach to help texture changes in wrinkling on the skin in a different fashion than any of the other devices that are currently out there,” Dr. Garden told this news organization after the conference. “I wanted to understand more in depth the different parameters that may impact the outcome” with this device, he added.
The thermomechanical fractional injury device, originally cleared by the US Food and Drug Administration (FDA) in 2021, with a second-generation device cleared in June 2023, deposits heat into the skin, producing controlled thermal injury to promote collagen and elastin production. The device uses only heat, not a laser, which penetrates the skin. A heat sensation on the skin during the procedure can affect patients differently depending on their level of tolerance, Dr. Garden said during his presentation.
Managing Patient Discomfort
Kachiu C. Lee, MD, MPH, of the Main Line Center for Laser Surgery in Ardmore, Pennsylvania, has used the device in her own practice and found that “it can definitely get a little bit uncomfortable for patients,” she said in an interview after the conference.
“I would say that as the doctor, my number one priority is to always make sure my patients are comfortable, especially when treating a sensitive area like the eyes,” added Dr. Lee, who was not involved with the study. “I don’t want them to suddenly jump or move from the discomfort when I have a device right next to their eye. I think that the patient comfort is very important to make sure that we’re managing their discomfort so that the procedure is tolerable.”
She added, “Dr. Garden’s study was effective at showing that surface anesthesia, whether it be with an ice pack 5 minutes before or a topical numbing cream, can be very effective in reducing the pain level while also not interfering with the efficacy of the treatment itself.”
Dr. Garden serves on the medical advisory board for Novoxel, maker of the device. Dr. Lee had no relevant disclosures.
A version of this article appeared on Medscape.com.
BALTIMORE — , a small study of the recently cleared device found.
The study enrolled 12 patients who were undergoing treatment for periorbital rhytides, or wrinkles, around the eyes. Seven of them received topical anesthetic cream 20 minutes before the procedure, while five were given ice packs to self-apply for 5 minutes beforehand. Patients received four treatment sessions with a month between sessions and were then evaluated up to 3 months after their last session. Study results were presented at the annual conference of the American Society for Laser Medicine and Surgery.
“Based on the approach that we had used, which was to keep the device parameters the same for those who received topical anesthetics and those who received ice, when we looked at the pain levels that the patients had relayed to us when we were doing the procedure, we found that both of them were almost exactly the same in terms of discomfort, a level of 3-4 out of 10, with 10 being the highest discomfort level,” lead investigator Jerome M. Garden, MD, said in an interview after the conference.
“In terms of patient satisfaction using a range of 0-5, again it was fairly equivalent” between the two groups, said Dr. Garden, professor of clinical dermatology and biomedical engineering at Northwestern University, Chicago. “And the overall satisfaction rate was high.”
The same device settings were used for all procedures: A pulse duration of 10 milliseconds and a protrusion depth of 400 micrometers. Double passes were applied using the standard device tip, with the smaller tip used in tighter areas, Dr. Garden said. Three patients were Fitzpatrick skin type (FST) I, six were FST II, and three were FST III.
Study Results
The results for the different anesthetic methods were almost identical. Those using ice reported a 0-10 average pain level of 3.95 ± 1.5, while those who received the topical anesthetic reported a pain level of 3.92 ± 1.5. In terms of self-graded improvement at 3-month follow-up, using a scale of 1-4, with 1 representing up to a 25% improvement and 4 a 75%-100% improvement, the patients using ice had a 2.6 ± 0.5 improvement and those using topical cream a 2.8 ± 0.5 improvement, Dr. Garden said during his presentation.
In terms of patient satisfaction, rated on a scale of 1-5, with 5 being very satisfied, the average grade was 3.9 ± 0.9, Dr. Garden added, with 70% rating ≥ 4.
“This is a relatively new device, which uses an approach to help texture changes in wrinkling on the skin in a different fashion than any of the other devices that are currently out there,” Dr. Garden told this news organization after the conference. “I wanted to understand more in depth the different parameters that may impact the outcome” with this device, he added.
The thermomechanical fractional injury device, originally cleared by the US Food and Drug Administration (FDA) in 2021, with a second-generation device cleared in June 2023, deposits heat into the skin, producing controlled thermal injury to promote collagen and elastin production. The device uses only heat, not a laser, which penetrates the skin. A heat sensation on the skin during the procedure can affect patients differently depending on their level of tolerance, Dr. Garden said during his presentation.
Managing Patient Discomfort
Kachiu C. Lee, MD, MPH, of the Main Line Center for Laser Surgery in Ardmore, Pennsylvania, has used the device in her own practice and found that “it can definitely get a little bit uncomfortable for patients,” she said in an interview after the conference.
“I would say that as the doctor, my number one priority is to always make sure my patients are comfortable, especially when treating a sensitive area like the eyes,” added Dr. Lee, who was not involved with the study. “I don’t want them to suddenly jump or move from the discomfort when I have a device right next to their eye. I think that the patient comfort is very important to make sure that we’re managing their discomfort so that the procedure is tolerable.”
She added, “Dr. Garden’s study was effective at showing that surface anesthesia, whether it be with an ice pack 5 minutes before or a topical numbing cream, can be very effective in reducing the pain level while also not interfering with the efficacy of the treatment itself.”
Dr. Garden serves on the medical advisory board for Novoxel, maker of the device. Dr. Lee had no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM ASLMS 2024
Neutrophils Take Center Stage in Growing Understanding of Colchicine’s Role in Treating Atherosclerotic Cardiovascular Disease
NEW YORK — New insights into colchicine’s disruption of the pathway that contributes to arterial inflammation and new clinical studies of the drug could pave the way toward greater use of the anti-inflammatory drug in patients with or at risk for atherosclerotic cardiovascular disease (ASCVD), researchers said at the 4th Annual Cardiometabolic Risk in Inflammatory Conditions conference.
Colchicine was approved by the US Food and Drug Administration (FDA) in June 2023 in a once-daily 0.5-mg formulation under the brand name Lodoco to reduce the risk for major adverse cardiovascular events (MACE) in patients with established atherosclerotic disease or with multiple risk factors for CVD. The Lodoco formulation is slightly smaller than the 0.6-mg formulation that’s taken twice daily for the prophylaxis and treatment of acute gout flares.
In a presentation at the conference, Binita Shah, MD, one of the principal investigators in trials of Lodoco, explained how the inflammatory pathway contributes to atherosclerosis and provided an update on how colchicine disrupts the pathway. Dr. Shah is an associate professor of medicine at New York University in New York City and director of research at NYU Langone Health Interventional Cardiology.
“Colchicine dampens inflammatory markers on neutrophils so that they are less likely to be attracted to inflamed or injured endothelium, which would be the site of where plaque is building up or where the plaque has ruptured in the setting of a heart attack,” Shah told this news organization after her presentation.
The Inflammatory Pathway
Dr. Shah explained that normal coronary endothelium resists adhesion by circulating leukocytes, but inflamed or injured coronary endothelium attracts those neutrophils via two types of selectins: L-selectins on neutrophils and E-selectins on endothelial cells. Those neutrophils then release inflammatory cytokines including interleukin-1 beta (IL-1ß), which then triggers production of IL-6 and, subsequently, high-sensitivity C-reactive protein (hsCRP), which contributes to plaque formation, she said.
“Colchicine affects these pathways with a balance for safety and effect on clinical outcomes, particularly to reduce recurrent myocardial infarction [MI],” Dr. Shah said during her presentation.
Results from the CIRT trial demonstrated that methotrexate is ineffective in blocking the adenosine-mediated anti-inflammatory pathway, Dr. Shah said, so focusing on the IL-1ß–IL-6–hsCRP pathway, which is known to work based on the results of the CANTOS trial, could pay dividends.
“This is where colchicine can potentially play a role,” she said.
Dr. Shah cited a secondary analysis of the CANTOS trial in which the magnitude of hsCRP reduction correlated with a reduction in MI, stroke, or cardiovascular death. The secondary analysis showed that patients who received canakinumab and achieved hsCRP ≥ 2 mg/L had a nonsignificant 5% lower risk and those who reached < 2 mg/L had a statistically significant 25% lower risk than those who received placebo.
The COPE-PCI Pilot trial demonstrated the benefit of targeting the interleukin pathways, she noted.
Further clarification of the role of colchicine in managing patients with acute coronary syndrome may come from two other randomized trials now underway, Dr. Shah said: POPCORN is evaluating colchicine to reduce MACE after noncardiac surgery, and CLEAR SYNERGY is evaluating the best timing for colchicine therapy after an acute MI.
Dr. Shah presented preliminary data from her group from a neutrophil biomarker substudy of CLEAR SYNERGY that isolated neutrophils from patients who had an acute MI. “We treated them with various doses of colchicine and showed that the interaction between those treated neutrophils [and] the endothelial cells were a lot lower; they were less sticky to endothelial cells as colchicine was administered,” she said in her presentation. She added that colchicine also reduced neutrophil chemotaxis and neutrophil activation and potentially inhibited inflammasomes, decreasing IL-1ß production.
What’s more, colchicine has been shown to not affect platelets alone but rather platelets at the site of inflammation or plaque rupture, Dr. Shah added. “At currently used doses, colchicine does not inhibit platelet activity [by] itself, so we’ve never seen increased bleeding events, but it will dampen neutrophils’ ability to latch onto a platelet that could contribute to a clot,” she later told this news organization.
“There are multiple studies, both retrospective studies in gout cohorts as well as prospective studies in the cardiovascular cohort, that all show consistently one thing, which is that colchicine continues to reduce the risk of having a recurrent MI in patients who either have cardiovascular disease or are at high risk of having cardiovascular disease,” she said.
“I think that’s very helpful to know that it’s not just one study — it’s not just a fluke, potentially a play of chance — but multiple studies consistently showing the same thing: That there’s a reduced risk of acute MI.”
Slow to Embrace Colchicine
Despite this evidence, cardiologists and rheumatologists have been slow to embrace colchicine for patients at risk for cardiovascular events, said Michael S. Garshick, MD, who attended the conference and is head of the Cardio-Rheumatology Program at NYU Langone. “What [Shah] really highlighted was that for a number of years now, we’ve had several clinical trials showing the benefit of low-dose colchicine to prevent atherosclerotic cardiovascular events, and yet despite these and that there’s now an indication to use low-dose colchicine to reduce cardiovascular disease, we’re still struggling for this medication to be taken up by the general cardiology community to treat high-risk patients.
“There’s still some work to do to prove that we need to break those barriers,” Dr. Garshick added. Some of the confusion surrounding the use of colchicine for ASCVD may be attributed to the 0.5-mg dose approved for CVD as opposed to the long-approved 0.6-mg dose for gout, he said. “People are generally confused: Is it OK to use the 0.6-mg dose?” Dr. Garshick said.
Potential gastrointestinal side effects may be another concerning factor, although, he added, “we didn’t see any major complications.” Another issue could be polypharmacy in many of these patients, he said.
Dr. Garshick concurred with Shah that the existing evidence supporting the use of colchicine to reduce risk for cardiovascular events is strong, but more will come out. “I think there’s going to be evolving data supporting it,” he said.
Dr. Shah disclosed financial relationships with Philips Volcano and Novo Nordisk. She is a principal investigator of the CLEAR SYNERGY biomarker substudy and the POPCORN trial. Dr. Garshick disclosed relationships with Kiniksa Pharmaceuticals, Agepha Pharma, Bristol Myers Squibb, and Horizon Therapeutics.
A version of this article appeared on Medscape.com .
NEW YORK — New insights into colchicine’s disruption of the pathway that contributes to arterial inflammation and new clinical studies of the drug could pave the way toward greater use of the anti-inflammatory drug in patients with or at risk for atherosclerotic cardiovascular disease (ASCVD), researchers said at the 4th Annual Cardiometabolic Risk in Inflammatory Conditions conference.
Colchicine was approved by the US Food and Drug Administration (FDA) in June 2023 in a once-daily 0.5-mg formulation under the brand name Lodoco to reduce the risk for major adverse cardiovascular events (MACE) in patients with established atherosclerotic disease or with multiple risk factors for CVD. The Lodoco formulation is slightly smaller than the 0.6-mg formulation that’s taken twice daily for the prophylaxis and treatment of acute gout flares.
In a presentation at the conference, Binita Shah, MD, one of the principal investigators in trials of Lodoco, explained how the inflammatory pathway contributes to atherosclerosis and provided an update on how colchicine disrupts the pathway. Dr. Shah is an associate professor of medicine at New York University in New York City and director of research at NYU Langone Health Interventional Cardiology.
“Colchicine dampens inflammatory markers on neutrophils so that they are less likely to be attracted to inflamed or injured endothelium, which would be the site of where plaque is building up or where the plaque has ruptured in the setting of a heart attack,” Shah told this news organization after her presentation.
The Inflammatory Pathway
Dr. Shah explained that normal coronary endothelium resists adhesion by circulating leukocytes, but inflamed or injured coronary endothelium attracts those neutrophils via two types of selectins: L-selectins on neutrophils and E-selectins on endothelial cells. Those neutrophils then release inflammatory cytokines including interleukin-1 beta (IL-1ß), which then triggers production of IL-6 and, subsequently, high-sensitivity C-reactive protein (hsCRP), which contributes to plaque formation, she said.
“Colchicine affects these pathways with a balance for safety and effect on clinical outcomes, particularly to reduce recurrent myocardial infarction [MI],” Dr. Shah said during her presentation.
Results from the CIRT trial demonstrated that methotrexate is ineffective in blocking the adenosine-mediated anti-inflammatory pathway, Dr. Shah said, so focusing on the IL-1ß–IL-6–hsCRP pathway, which is known to work based on the results of the CANTOS trial, could pay dividends.
“This is where colchicine can potentially play a role,” she said.
Dr. Shah cited a secondary analysis of the CANTOS trial in which the magnitude of hsCRP reduction correlated with a reduction in MI, stroke, or cardiovascular death. The secondary analysis showed that patients who received canakinumab and achieved hsCRP ≥ 2 mg/L had a nonsignificant 5% lower risk and those who reached < 2 mg/L had a statistically significant 25% lower risk than those who received placebo.
The COPE-PCI Pilot trial demonstrated the benefit of targeting the interleukin pathways, she noted.
Further clarification of the role of colchicine in managing patients with acute coronary syndrome may come from two other randomized trials now underway, Dr. Shah said: POPCORN is evaluating colchicine to reduce MACE after noncardiac surgery, and CLEAR SYNERGY is evaluating the best timing for colchicine therapy after an acute MI.
Dr. Shah presented preliminary data from her group from a neutrophil biomarker substudy of CLEAR SYNERGY that isolated neutrophils from patients who had an acute MI. “We treated them with various doses of colchicine and showed that the interaction between those treated neutrophils [and] the endothelial cells were a lot lower; they were less sticky to endothelial cells as colchicine was administered,” she said in her presentation. She added that colchicine also reduced neutrophil chemotaxis and neutrophil activation and potentially inhibited inflammasomes, decreasing IL-1ß production.
What’s more, colchicine has been shown to not affect platelets alone but rather platelets at the site of inflammation or plaque rupture, Dr. Shah added. “At currently used doses, colchicine does not inhibit platelet activity [by] itself, so we’ve never seen increased bleeding events, but it will dampen neutrophils’ ability to latch onto a platelet that could contribute to a clot,” she later told this news organization.
“There are multiple studies, both retrospective studies in gout cohorts as well as prospective studies in the cardiovascular cohort, that all show consistently one thing, which is that colchicine continues to reduce the risk of having a recurrent MI in patients who either have cardiovascular disease or are at high risk of having cardiovascular disease,” she said.
“I think that’s very helpful to know that it’s not just one study — it’s not just a fluke, potentially a play of chance — but multiple studies consistently showing the same thing: That there’s a reduced risk of acute MI.”
Slow to Embrace Colchicine
Despite this evidence, cardiologists and rheumatologists have been slow to embrace colchicine for patients at risk for cardiovascular events, said Michael S. Garshick, MD, who attended the conference and is head of the Cardio-Rheumatology Program at NYU Langone. “What [Shah] really highlighted was that for a number of years now, we’ve had several clinical trials showing the benefit of low-dose colchicine to prevent atherosclerotic cardiovascular events, and yet despite these and that there’s now an indication to use low-dose colchicine to reduce cardiovascular disease, we’re still struggling for this medication to be taken up by the general cardiology community to treat high-risk patients.
“There’s still some work to do to prove that we need to break those barriers,” Dr. Garshick added. Some of the confusion surrounding the use of colchicine for ASCVD may be attributed to the 0.5-mg dose approved for CVD as opposed to the long-approved 0.6-mg dose for gout, he said. “People are generally confused: Is it OK to use the 0.6-mg dose?” Dr. Garshick said.
Potential gastrointestinal side effects may be another concerning factor, although, he added, “we didn’t see any major complications.” Another issue could be polypharmacy in many of these patients, he said.
Dr. Garshick concurred with Shah that the existing evidence supporting the use of colchicine to reduce risk for cardiovascular events is strong, but more will come out. “I think there’s going to be evolving data supporting it,” he said.
Dr. Shah disclosed financial relationships with Philips Volcano and Novo Nordisk. She is a principal investigator of the CLEAR SYNERGY biomarker substudy and the POPCORN trial. Dr. Garshick disclosed relationships with Kiniksa Pharmaceuticals, Agepha Pharma, Bristol Myers Squibb, and Horizon Therapeutics.
A version of this article appeared on Medscape.com .
NEW YORK — New insights into colchicine’s disruption of the pathway that contributes to arterial inflammation and new clinical studies of the drug could pave the way toward greater use of the anti-inflammatory drug in patients with or at risk for atherosclerotic cardiovascular disease (ASCVD), researchers said at the 4th Annual Cardiometabolic Risk in Inflammatory Conditions conference.
Colchicine was approved by the US Food and Drug Administration (FDA) in June 2023 in a once-daily 0.5-mg formulation under the brand name Lodoco to reduce the risk for major adverse cardiovascular events (MACE) in patients with established atherosclerotic disease or with multiple risk factors for CVD. The Lodoco formulation is slightly smaller than the 0.6-mg formulation that’s taken twice daily for the prophylaxis and treatment of acute gout flares.
In a presentation at the conference, Binita Shah, MD, one of the principal investigators in trials of Lodoco, explained how the inflammatory pathway contributes to atherosclerosis and provided an update on how colchicine disrupts the pathway. Dr. Shah is an associate professor of medicine at New York University in New York City and director of research at NYU Langone Health Interventional Cardiology.
“Colchicine dampens inflammatory markers on neutrophils so that they are less likely to be attracted to inflamed or injured endothelium, which would be the site of where plaque is building up or where the plaque has ruptured in the setting of a heart attack,” Shah told this news organization after her presentation.
The Inflammatory Pathway
Dr. Shah explained that normal coronary endothelium resists adhesion by circulating leukocytes, but inflamed or injured coronary endothelium attracts those neutrophils via two types of selectins: L-selectins on neutrophils and E-selectins on endothelial cells. Those neutrophils then release inflammatory cytokines including interleukin-1 beta (IL-1ß), which then triggers production of IL-6 and, subsequently, high-sensitivity C-reactive protein (hsCRP), which contributes to plaque formation, she said.
“Colchicine affects these pathways with a balance for safety and effect on clinical outcomes, particularly to reduce recurrent myocardial infarction [MI],” Dr. Shah said during her presentation.
Results from the CIRT trial demonstrated that methotrexate is ineffective in blocking the adenosine-mediated anti-inflammatory pathway, Dr. Shah said, so focusing on the IL-1ß–IL-6–hsCRP pathway, which is known to work based on the results of the CANTOS trial, could pay dividends.
“This is where colchicine can potentially play a role,” she said.
Dr. Shah cited a secondary analysis of the CANTOS trial in which the magnitude of hsCRP reduction correlated with a reduction in MI, stroke, or cardiovascular death. The secondary analysis showed that patients who received canakinumab and achieved hsCRP ≥ 2 mg/L had a nonsignificant 5% lower risk and those who reached < 2 mg/L had a statistically significant 25% lower risk than those who received placebo.
The COPE-PCI Pilot trial demonstrated the benefit of targeting the interleukin pathways, she noted.
Further clarification of the role of colchicine in managing patients with acute coronary syndrome may come from two other randomized trials now underway, Dr. Shah said: POPCORN is evaluating colchicine to reduce MACE after noncardiac surgery, and CLEAR SYNERGY is evaluating the best timing for colchicine therapy after an acute MI.
Dr. Shah presented preliminary data from her group from a neutrophil biomarker substudy of CLEAR SYNERGY that isolated neutrophils from patients who had an acute MI. “We treated them with various doses of colchicine and showed that the interaction between those treated neutrophils [and] the endothelial cells were a lot lower; they were less sticky to endothelial cells as colchicine was administered,” she said in her presentation. She added that colchicine also reduced neutrophil chemotaxis and neutrophil activation and potentially inhibited inflammasomes, decreasing IL-1ß production.
What’s more, colchicine has been shown to not affect platelets alone but rather platelets at the site of inflammation or plaque rupture, Dr. Shah added. “At currently used doses, colchicine does not inhibit platelet activity [by] itself, so we’ve never seen increased bleeding events, but it will dampen neutrophils’ ability to latch onto a platelet that could contribute to a clot,” she later told this news organization.
“There are multiple studies, both retrospective studies in gout cohorts as well as prospective studies in the cardiovascular cohort, that all show consistently one thing, which is that colchicine continues to reduce the risk of having a recurrent MI in patients who either have cardiovascular disease or are at high risk of having cardiovascular disease,” she said.
“I think that’s very helpful to know that it’s not just one study — it’s not just a fluke, potentially a play of chance — but multiple studies consistently showing the same thing: That there’s a reduced risk of acute MI.”
Slow to Embrace Colchicine
Despite this evidence, cardiologists and rheumatologists have been slow to embrace colchicine for patients at risk for cardiovascular events, said Michael S. Garshick, MD, who attended the conference and is head of the Cardio-Rheumatology Program at NYU Langone. “What [Shah] really highlighted was that for a number of years now, we’ve had several clinical trials showing the benefit of low-dose colchicine to prevent atherosclerotic cardiovascular events, and yet despite these and that there’s now an indication to use low-dose colchicine to reduce cardiovascular disease, we’re still struggling for this medication to be taken up by the general cardiology community to treat high-risk patients.
“There’s still some work to do to prove that we need to break those barriers,” Dr. Garshick added. Some of the confusion surrounding the use of colchicine for ASCVD may be attributed to the 0.5-mg dose approved for CVD as opposed to the long-approved 0.6-mg dose for gout, he said. “People are generally confused: Is it OK to use the 0.6-mg dose?” Dr. Garshick said.
Potential gastrointestinal side effects may be another concerning factor, although, he added, “we didn’t see any major complications.” Another issue could be polypharmacy in many of these patients, he said.
Dr. Garshick concurred with Shah that the existing evidence supporting the use of colchicine to reduce risk for cardiovascular events is strong, but more will come out. “I think there’s going to be evolving data supporting it,” he said.
Dr. Shah disclosed financial relationships with Philips Volcano and Novo Nordisk. She is a principal investigator of the CLEAR SYNERGY biomarker substudy and the POPCORN trial. Dr. Garshick disclosed relationships with Kiniksa Pharmaceuticals, Agepha Pharma, Bristol Myers Squibb, and Horizon Therapeutics.
A version of this article appeared on Medscape.com .
Study Demonstrates Faster Recovery, Less Pain After Facial Resurfacing With 2910-nm Laser
BALTIMORE — A — while causing less discomfort and downtime compared with conventional fractional lasers, a small single-center study showed.
The study enrolled 15 patients who had three treatment sessions with the 2910-nm laser. “It’s highly customizable,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, told this news organization. “It has a really fast time in healing compared to traditional abatable lasers; the healing time is 5-7 days vs several weeks.” Dr. Murray presented the results at the annual meeting of the American Society for Laser Medicine and Surgery (ASLMS).
The Technology Behind the Laser
The 2910-nm erbium-doped fluoride glass fiber laser is a mid-infrared ablative fractional device that operates at peak water absorption. It’s designed to cause minimal residual thermal damage, resulting in less discomfort, shorter downtime, and potentially fewer side effects than conventional ablative lasers, Dr. Murray said.
Because of the way the pulses are delivered, “it’s far less painful than traditional fractional ablative lasers, so you can use mainly topical numbing; you don’t need nerve blocks, you don’t have to infiltrate lidocaine, you don’t have to put the patient under anesthesia,” she said.
“Because of the wavelength, how pulses are delivered and how customizable the settings are, it’s safer to use in darker skin types,” and the density, depth, and the amount of coagulation applied into the skin are customizable, Dr. Murray added.
The laser also delivers pulses in a different way than the conventional 2940-nm erbium and CO2 lasers, she explained. “Traditional lasers do it all in one pulse. This laser uses micropulses with relaxation time in between pulses, so the body interprets it as less painful and allows pressure and steam to escape out of the channel, which results in faster healing.”
The study patients had topical anesthetic cream applied to their faces 45-60 minutes before the procedure. Multiple passes were made using both superficial and deep laser modes. The average patient age was 65.7 years, and Fitzpatrick skin types included I (n = 3), II (n = 3), III (n = 7), and IV (n = 2). On a scale of 0-10, the average level of discomfort was 4.9, and the average patient satisfaction after three treatments was 4.8, Dr. Murray said.
For cosmetic improvement, the study used the 5-point Global Aesthetic Improvement Scale (GAIS). Blinded reviewers evaluated digital images and determined an average GAIS score of 3.2 for overall appearance, 2.9 for wrinkles, 3.6 for pigment, 3.1 for skin texture, and 2.6 for skin laxity.
When the patients themselves reviewed the digital images, the average GAIS score was 3.8 for overall appearance.
Side effects, said Dr. Murray, were transient, with edema and soft-tissue crusting lasting 3-5 days and erythema resolving in 1-2 weeks on average. One case of postinflammatory hyperpigmentation (PIH) did arise, which was linked to allergic contact dermatitis from the healing ointment. That patient stayed in the study and had complete resolution of the PIH.
Study Stands Out
A number of studies of the 2910-nm erbium-doped fluoride glass fiber laser have emerged over the past half year, Ritu Swali, MD, who was an American Society of Dermatologic Surgery fellow at a practice in Houston, said in an interview at the meeting. But this one stands out because of the evidence surrounding its use.
Most people are using this laser for facial resurfacing, “and we want to know that we have a technology ... with shorter downtime and easier wound care and just more comfort,” she said.
She noted that with conventional lasers, most patients get nerve blocks and some even opt for general anesthesia. “To be able to do the levels of facial resurfacing [Dr. Murray] is doing without having to do all of that pain management is pretty amazing,” Dr. Swali added.
The speed of the procedure and the relatively short downtime are also noteworthy, she said. “The huge advantage is having so much less pain from the procedure itself, so you’re able to do it faster because they’re tolerating it so well and you’re not having to take breaks,” she said.
As for downtime, Dr. Swali added, “these patients are coming in on a Thursday and they are back up and running by Monday,” as opposed to weeks that is typical with a conventional laser. This laser platform also avoids the pigmentation problems that can come with continuing and aggressive treatment with conventional lasers, she said.
Dr. Murray disclosed relationships with Acclaro Medical, the manufacturer of the laser. Dr. Swali has no relationships to disclose.
A version of this article first appeared on Medscape.com.
BALTIMORE — A — while causing less discomfort and downtime compared with conventional fractional lasers, a small single-center study showed.
The study enrolled 15 patients who had three treatment sessions with the 2910-nm laser. “It’s highly customizable,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, told this news organization. “It has a really fast time in healing compared to traditional abatable lasers; the healing time is 5-7 days vs several weeks.” Dr. Murray presented the results at the annual meeting of the American Society for Laser Medicine and Surgery (ASLMS).
The Technology Behind the Laser
The 2910-nm erbium-doped fluoride glass fiber laser is a mid-infrared ablative fractional device that operates at peak water absorption. It’s designed to cause minimal residual thermal damage, resulting in less discomfort, shorter downtime, and potentially fewer side effects than conventional ablative lasers, Dr. Murray said.
Because of the way the pulses are delivered, “it’s far less painful than traditional fractional ablative lasers, so you can use mainly topical numbing; you don’t need nerve blocks, you don’t have to infiltrate lidocaine, you don’t have to put the patient under anesthesia,” she said.
“Because of the wavelength, how pulses are delivered and how customizable the settings are, it’s safer to use in darker skin types,” and the density, depth, and the amount of coagulation applied into the skin are customizable, Dr. Murray added.
The laser also delivers pulses in a different way than the conventional 2940-nm erbium and CO2 lasers, she explained. “Traditional lasers do it all in one pulse. This laser uses micropulses with relaxation time in between pulses, so the body interprets it as less painful and allows pressure and steam to escape out of the channel, which results in faster healing.”
The study patients had topical anesthetic cream applied to their faces 45-60 minutes before the procedure. Multiple passes were made using both superficial and deep laser modes. The average patient age was 65.7 years, and Fitzpatrick skin types included I (n = 3), II (n = 3), III (n = 7), and IV (n = 2). On a scale of 0-10, the average level of discomfort was 4.9, and the average patient satisfaction after three treatments was 4.8, Dr. Murray said.
For cosmetic improvement, the study used the 5-point Global Aesthetic Improvement Scale (GAIS). Blinded reviewers evaluated digital images and determined an average GAIS score of 3.2 for overall appearance, 2.9 for wrinkles, 3.6 for pigment, 3.1 for skin texture, and 2.6 for skin laxity.
When the patients themselves reviewed the digital images, the average GAIS score was 3.8 for overall appearance.
Side effects, said Dr. Murray, were transient, with edema and soft-tissue crusting lasting 3-5 days and erythema resolving in 1-2 weeks on average. One case of postinflammatory hyperpigmentation (PIH) did arise, which was linked to allergic contact dermatitis from the healing ointment. That patient stayed in the study and had complete resolution of the PIH.
Study Stands Out
A number of studies of the 2910-nm erbium-doped fluoride glass fiber laser have emerged over the past half year, Ritu Swali, MD, who was an American Society of Dermatologic Surgery fellow at a practice in Houston, said in an interview at the meeting. But this one stands out because of the evidence surrounding its use.
Most people are using this laser for facial resurfacing, “and we want to know that we have a technology ... with shorter downtime and easier wound care and just more comfort,” she said.
She noted that with conventional lasers, most patients get nerve blocks and some even opt for general anesthesia. “To be able to do the levels of facial resurfacing [Dr. Murray] is doing without having to do all of that pain management is pretty amazing,” Dr. Swali added.
The speed of the procedure and the relatively short downtime are also noteworthy, she said. “The huge advantage is having so much less pain from the procedure itself, so you’re able to do it faster because they’re tolerating it so well and you’re not having to take breaks,” she said.
As for downtime, Dr. Swali added, “these patients are coming in on a Thursday and they are back up and running by Monday,” as opposed to weeks that is typical with a conventional laser. This laser platform also avoids the pigmentation problems that can come with continuing and aggressive treatment with conventional lasers, she said.
Dr. Murray disclosed relationships with Acclaro Medical, the manufacturer of the laser. Dr. Swali has no relationships to disclose.
A version of this article first appeared on Medscape.com.
BALTIMORE — A — while causing less discomfort and downtime compared with conventional fractional lasers, a small single-center study showed.
The study enrolled 15 patients who had three treatment sessions with the 2910-nm laser. “It’s highly customizable,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, told this news organization. “It has a really fast time in healing compared to traditional abatable lasers; the healing time is 5-7 days vs several weeks.” Dr. Murray presented the results at the annual meeting of the American Society for Laser Medicine and Surgery (ASLMS).
The Technology Behind the Laser
The 2910-nm erbium-doped fluoride glass fiber laser is a mid-infrared ablative fractional device that operates at peak water absorption. It’s designed to cause minimal residual thermal damage, resulting in less discomfort, shorter downtime, and potentially fewer side effects than conventional ablative lasers, Dr. Murray said.
Because of the way the pulses are delivered, “it’s far less painful than traditional fractional ablative lasers, so you can use mainly topical numbing; you don’t need nerve blocks, you don’t have to infiltrate lidocaine, you don’t have to put the patient under anesthesia,” she said.
“Because of the wavelength, how pulses are delivered and how customizable the settings are, it’s safer to use in darker skin types,” and the density, depth, and the amount of coagulation applied into the skin are customizable, Dr. Murray added.
The laser also delivers pulses in a different way than the conventional 2940-nm erbium and CO2 lasers, she explained. “Traditional lasers do it all in one pulse. This laser uses micropulses with relaxation time in between pulses, so the body interprets it as less painful and allows pressure and steam to escape out of the channel, which results in faster healing.”
The study patients had topical anesthetic cream applied to their faces 45-60 minutes before the procedure. Multiple passes were made using both superficial and deep laser modes. The average patient age was 65.7 years, and Fitzpatrick skin types included I (n = 3), II (n = 3), III (n = 7), and IV (n = 2). On a scale of 0-10, the average level of discomfort was 4.9, and the average patient satisfaction after three treatments was 4.8, Dr. Murray said.
For cosmetic improvement, the study used the 5-point Global Aesthetic Improvement Scale (GAIS). Blinded reviewers evaluated digital images and determined an average GAIS score of 3.2 for overall appearance, 2.9 for wrinkles, 3.6 for pigment, 3.1 for skin texture, and 2.6 for skin laxity.
When the patients themselves reviewed the digital images, the average GAIS score was 3.8 for overall appearance.
Side effects, said Dr. Murray, were transient, with edema and soft-tissue crusting lasting 3-5 days and erythema resolving in 1-2 weeks on average. One case of postinflammatory hyperpigmentation (PIH) did arise, which was linked to allergic contact dermatitis from the healing ointment. That patient stayed in the study and had complete resolution of the PIH.
Study Stands Out
A number of studies of the 2910-nm erbium-doped fluoride glass fiber laser have emerged over the past half year, Ritu Swali, MD, who was an American Society of Dermatologic Surgery fellow at a practice in Houston, said in an interview at the meeting. But this one stands out because of the evidence surrounding its use.
Most people are using this laser for facial resurfacing, “and we want to know that we have a technology ... with shorter downtime and easier wound care and just more comfort,” she said.
She noted that with conventional lasers, most patients get nerve blocks and some even opt for general anesthesia. “To be able to do the levels of facial resurfacing [Dr. Murray] is doing without having to do all of that pain management is pretty amazing,” Dr. Swali added.
The speed of the procedure and the relatively short downtime are also noteworthy, she said. “The huge advantage is having so much less pain from the procedure itself, so you’re able to do it faster because they’re tolerating it so well and you’re not having to take breaks,” she said.
As for downtime, Dr. Swali added, “these patients are coming in on a Thursday and they are back up and running by Monday,” as opposed to weeks that is typical with a conventional laser. This laser platform also avoids the pigmentation problems that can come with continuing and aggressive treatment with conventional lasers, she said.
Dr. Murray disclosed relationships with Acclaro Medical, the manufacturer of the laser. Dr. Swali has no relationships to disclose.
A version of this article first appeared on Medscape.com.
FROM ASLMS 2024
First Results From Laser-Related Adverse Events Registry Reported
BALTIMORE — A relatively . But the process of reporting AEs to the registry needs to be made easier to attract more cases and provide a more complete picture of complications after dermatologic procedures, a researcher and observer said.
The Cutaneous Procedures Adverse Events Reporting Registry (CAPER) was established in 2021 to track AEs from dermatologic procedures. Since then, it has logged a total of 81 cases and 147 AEs from 27 unique procedures, Eric Koza, MD, a postdoctoral research fellow in the Department of Dermatology at Northwestern University, Chicago, reported at the annual conference of the American Society for Laser Medicine and Surgery.
“The takeaways from this project is that 20 laser and energy device treatments have been reported to the registry, half of which were nonablative laser treatments,” Dr. Koza said in presenting the results. “Of the adverse events reported, nonphysicians and non-dermatologic physicians were more likely to be associated with severe or persistent adverse events.”
The American Society for Dermatologic Surgery Association and the Northwestern University Department of Dermatology launched CAPER. Previously, Dr. Koza said, AEs were typically reported only through the Food and Drug Administration’s AE reporting system. He noted that CAPER is the only voluntary national reporting registry for AEs from dermatologic procedures.
What the Registry Shows So Far
The registry matched 72 of the 81 cases with type of provider, with dermatologist-conducted procedures (51, 70.8%) comprising the majority, followed by nonphysician-conducted procedures (14, 19.4%) and nondermatologist physician–conducted procedures (7, 9.7%).
Of the 81 total cases, the following reports were related to laser and energy device treatments: 12 (14.3%) from nonablative laser treatments, five (6%) from light treatments, and three (3.6%) from ablative laser treatments, Dr. Koza said.
Among nonablative laser treatments, the most common AE was blistering (six reports, 50%). Scar, pain, and hypopigmentation accounted for two cases each (16.67%). Dermatologists performed seven of these cases (58.3%); nonphysicians, four (33.3%); and a non-dermatologist physician, one (8.3%).
For intense pulsed-light treatments, burns were the most common AEs (three reports, 60%), with swelling and inflammation each accounting for one case (20%). Three of these cases (75%) were confirmed to have been performed by nonphysicians.
The ablative laser treatment AEs included one case each of hypopigmentation, scar, and erythema. Two of the three cases were confirmed to have been performed by dermatologists.
Dr. Koza acknowledged the low number of cases is a limitation of this analysis of registry reports. A future goal for CAPER is to publicize it more, he said. “The registry is only 3 years old,” he told this news organization. “Hopefully, we can get more data as time goes on. We’ve been getting more and more each year.” CAPER adapted data entry forms used in other registries.
Submitting a case to the registry takes about 15 minutes of the provider’s time, Dr. Koza said. “We can streamline that to make it easier for people to submit their adverse events,” he said in an interview.
Only registry staff have access to the reports, and when reported, the data “is de-identified and any identifying information pertaining to the patient or reporter is removed,” according to a statement on the CAPER website.
‘Needs a Little Help’
Jennifer Lin, MD, a dermatologist at Brigham and Women’s Hospital and Dana-Farber Cancer Institute in Boston, who was at the meeting, commented on the onerous reporting process and the “low” enrollment. “It’s such an important initiative and with everyone over-logging e-mails, a 15-minute entry just is not going to cut it,” she told this news organization.
For providers, reporting AEs is stressful, she said. “As it is, it’s hard to voluntarily submit an adverse event,” Dr. Lin continued. “There’s a feeling of shame. Hospitals require it in order to monitor adverse events, but there’s no monitoring when you’re out in your own private practice.”
“The idea is excellent, but I think to facilitate better enrollment, the word has to get out at all these meetings” and make it easier to submit cases, Dr. Lin added. “It’s a good idea, but it needs a little help.”
Information on submitting AE reports to CAPER is available on the CAPER website.
Dr. Koza and Dr. Lin had no relevant relationships to disclose.
A version of this article first appeared on Medscape.com.
BALTIMORE — A relatively . But the process of reporting AEs to the registry needs to be made easier to attract more cases and provide a more complete picture of complications after dermatologic procedures, a researcher and observer said.
The Cutaneous Procedures Adverse Events Reporting Registry (CAPER) was established in 2021 to track AEs from dermatologic procedures. Since then, it has logged a total of 81 cases and 147 AEs from 27 unique procedures, Eric Koza, MD, a postdoctoral research fellow in the Department of Dermatology at Northwestern University, Chicago, reported at the annual conference of the American Society for Laser Medicine and Surgery.
“The takeaways from this project is that 20 laser and energy device treatments have been reported to the registry, half of which were nonablative laser treatments,” Dr. Koza said in presenting the results. “Of the adverse events reported, nonphysicians and non-dermatologic physicians were more likely to be associated with severe or persistent adverse events.”
The American Society for Dermatologic Surgery Association and the Northwestern University Department of Dermatology launched CAPER. Previously, Dr. Koza said, AEs were typically reported only through the Food and Drug Administration’s AE reporting system. He noted that CAPER is the only voluntary national reporting registry for AEs from dermatologic procedures.
What the Registry Shows So Far
The registry matched 72 of the 81 cases with type of provider, with dermatologist-conducted procedures (51, 70.8%) comprising the majority, followed by nonphysician-conducted procedures (14, 19.4%) and nondermatologist physician–conducted procedures (7, 9.7%).
Of the 81 total cases, the following reports were related to laser and energy device treatments: 12 (14.3%) from nonablative laser treatments, five (6%) from light treatments, and three (3.6%) from ablative laser treatments, Dr. Koza said.
Among nonablative laser treatments, the most common AE was blistering (six reports, 50%). Scar, pain, and hypopigmentation accounted for two cases each (16.67%). Dermatologists performed seven of these cases (58.3%); nonphysicians, four (33.3%); and a non-dermatologist physician, one (8.3%).
For intense pulsed-light treatments, burns were the most common AEs (three reports, 60%), with swelling and inflammation each accounting for one case (20%). Three of these cases (75%) were confirmed to have been performed by nonphysicians.
The ablative laser treatment AEs included one case each of hypopigmentation, scar, and erythema. Two of the three cases were confirmed to have been performed by dermatologists.
Dr. Koza acknowledged the low number of cases is a limitation of this analysis of registry reports. A future goal for CAPER is to publicize it more, he said. “The registry is only 3 years old,” he told this news organization. “Hopefully, we can get more data as time goes on. We’ve been getting more and more each year.” CAPER adapted data entry forms used in other registries.
Submitting a case to the registry takes about 15 minutes of the provider’s time, Dr. Koza said. “We can streamline that to make it easier for people to submit their adverse events,” he said in an interview.
Only registry staff have access to the reports, and when reported, the data “is de-identified and any identifying information pertaining to the patient or reporter is removed,” according to a statement on the CAPER website.
‘Needs a Little Help’
Jennifer Lin, MD, a dermatologist at Brigham and Women’s Hospital and Dana-Farber Cancer Institute in Boston, who was at the meeting, commented on the onerous reporting process and the “low” enrollment. “It’s such an important initiative and with everyone over-logging e-mails, a 15-minute entry just is not going to cut it,” she told this news organization.
For providers, reporting AEs is stressful, she said. “As it is, it’s hard to voluntarily submit an adverse event,” Dr. Lin continued. “There’s a feeling of shame. Hospitals require it in order to monitor adverse events, but there’s no monitoring when you’re out in your own private practice.”
“The idea is excellent, but I think to facilitate better enrollment, the word has to get out at all these meetings” and make it easier to submit cases, Dr. Lin added. “It’s a good idea, but it needs a little help.”
Information on submitting AE reports to CAPER is available on the CAPER website.
Dr. Koza and Dr. Lin had no relevant relationships to disclose.
A version of this article first appeared on Medscape.com.
BALTIMORE — A relatively . But the process of reporting AEs to the registry needs to be made easier to attract more cases and provide a more complete picture of complications after dermatologic procedures, a researcher and observer said.
The Cutaneous Procedures Adverse Events Reporting Registry (CAPER) was established in 2021 to track AEs from dermatologic procedures. Since then, it has logged a total of 81 cases and 147 AEs from 27 unique procedures, Eric Koza, MD, a postdoctoral research fellow in the Department of Dermatology at Northwestern University, Chicago, reported at the annual conference of the American Society for Laser Medicine and Surgery.
“The takeaways from this project is that 20 laser and energy device treatments have been reported to the registry, half of which were nonablative laser treatments,” Dr. Koza said in presenting the results. “Of the adverse events reported, nonphysicians and non-dermatologic physicians were more likely to be associated with severe or persistent adverse events.”
The American Society for Dermatologic Surgery Association and the Northwestern University Department of Dermatology launched CAPER. Previously, Dr. Koza said, AEs were typically reported only through the Food and Drug Administration’s AE reporting system. He noted that CAPER is the only voluntary national reporting registry for AEs from dermatologic procedures.
What the Registry Shows So Far
The registry matched 72 of the 81 cases with type of provider, with dermatologist-conducted procedures (51, 70.8%) comprising the majority, followed by nonphysician-conducted procedures (14, 19.4%) and nondermatologist physician–conducted procedures (7, 9.7%).
Of the 81 total cases, the following reports were related to laser and energy device treatments: 12 (14.3%) from nonablative laser treatments, five (6%) from light treatments, and three (3.6%) from ablative laser treatments, Dr. Koza said.
Among nonablative laser treatments, the most common AE was blistering (six reports, 50%). Scar, pain, and hypopigmentation accounted for two cases each (16.67%). Dermatologists performed seven of these cases (58.3%); nonphysicians, four (33.3%); and a non-dermatologist physician, one (8.3%).
For intense pulsed-light treatments, burns were the most common AEs (three reports, 60%), with swelling and inflammation each accounting for one case (20%). Three of these cases (75%) were confirmed to have been performed by nonphysicians.
The ablative laser treatment AEs included one case each of hypopigmentation, scar, and erythema. Two of the three cases were confirmed to have been performed by dermatologists.
Dr. Koza acknowledged the low number of cases is a limitation of this analysis of registry reports. A future goal for CAPER is to publicize it more, he said. “The registry is only 3 years old,” he told this news organization. “Hopefully, we can get more data as time goes on. We’ve been getting more and more each year.” CAPER adapted data entry forms used in other registries.
Submitting a case to the registry takes about 15 minutes of the provider’s time, Dr. Koza said. “We can streamline that to make it easier for people to submit their adverse events,” he said in an interview.
Only registry staff have access to the reports, and when reported, the data “is de-identified and any identifying information pertaining to the patient or reporter is removed,” according to a statement on the CAPER website.
‘Needs a Little Help’
Jennifer Lin, MD, a dermatologist at Brigham and Women’s Hospital and Dana-Farber Cancer Institute in Boston, who was at the meeting, commented on the onerous reporting process and the “low” enrollment. “It’s such an important initiative and with everyone over-logging e-mails, a 15-minute entry just is not going to cut it,” she told this news organization.
For providers, reporting AEs is stressful, she said. “As it is, it’s hard to voluntarily submit an adverse event,” Dr. Lin continued. “There’s a feeling of shame. Hospitals require it in order to monitor adverse events, but there’s no monitoring when you’re out in your own private practice.”
“The idea is excellent, but I think to facilitate better enrollment, the word has to get out at all these meetings” and make it easier to submit cases, Dr. Lin added. “It’s a good idea, but it needs a little help.”
Information on submitting AE reports to CAPER is available on the CAPER website.
Dr. Koza and Dr. Lin had no relevant relationships to disclose.
A version of this article first appeared on Medscape.com.
FROM ASLMS 2024
Lentigines: Study Finds Less PIH With Modified Laser Treatment
BALTIMORE — Laser treatment for solar lentigines in individuals with darker skin types has long been associated with a higher risk of postinflammatory hyperpigmentation (PIH), but.
The study enrolled 27 patients with solar lentigines and Fitzpatrick skin types (FSTs) III-IV, Woraphong Manuskiatti, MD, professor of dermatology at Siriraj Hospital, Mahidol University, Bangkok, reported at the annual meeting of the American Society for Laser Medicine and Surgery. They received the fractional beam treatment on one side of the face and the full-beam on the other side. At 6 months, the incidence of PIH was about 81% lower on the fractional-beam side, Dr. Manuskiatti said.
“In the past, when we used laser to treat pigmented lesions, we used the so-called full-beam technique on the pigmented area,” Dr. Manuskiatti told this news organization. “From the study, we found that you don’t need to treat it at 100%. You can fractionally treat the pigmented lesion and get a really comparable treatment outcome and, at that reduced beam, less incidence of postinflammatory hyperpigmentation.”
Study Design and Results
Of the 27 patients in the study, 12 were FST III (44%), 14 were FST IV (52%), and one was FST V (4%). On the fractional-beam side, the laser was delivered through a 9-mm spot size with an average fluence of 0.47 J/cm² at a frequency of 2 Hz for a total of two passes without pulse overlapping. On the full-beam side, the laser was operated with a 4.5-mm handpiece, with fluence ranging from 0.3 to 0.7 J/cm² (using an endpoint of slight darkening of the pigmented lesion) at 2 Hz.
The patients received a single treatment and had a clinical evaluation and color reading assessments at 2 weeks, 1 month, 3 months, and 6 months after the treatment. Twenty-five patients completed the study.
The researchers found no statistically significant differences in lesional clearance between the two techniques at any of the follow-up assessments, Dr. Manuskiatti said. “This might be one of the alternative treatments of treating solar lentigines in dark-skinned patients,” he said when presenting the study results.
He reported the rates of PIH on the full-beam and fractional-beam sides, respectively, at the following intervals were: 64% and 8% at 2 weeks, 80% and 32% at 1 month, 96% and 36% at 3 months, and 88% and 16% at 6 months.
“The incidence of PIH on the full-beam side was statistically higher than that on the fractional-beam side throughout the follow-up period,” he said. Transient and mild hypopigmentation was observed in one patient (4%) on the fractional-beam side and in five (20%) on the full-beam side. Dr. Manuskiatti added that no other adverse effects were documented during the study.
“ Normally when you use laser to treat skin type I or II, you don’t have … PIH or darkening of the skin,” Dr. Manuskiatti told this news organization, “but when you have skin type III and above, you run into a really high incidence of postinflammatory hyperpigmentation — and treating that with fractional beam can lead to a reduced incidence of darkening of the skin afterward.”
A Lower-Cost Option
This study showed that the 532-nm picosecond laser with fractional beam MLA is a useful option for patients with darker skin types, Kelly Stankiewicz, MD, a dermatologist who practices in Park City, Utah, and moderated the session where these results were presented, told this news organization.
“The most challenging thing about treating lentigines in darker skin types is preventing potential side effects, mainly dyspigmentation,” she said after the meeting. “These side effects are, for the most part, temporary, but they can take 6-18 months to resolve, so it’s important to prevent them in the first place.”
She noted that the 532-nm and 1064-nm wavelengths are the most commonly available for picosecond lasers and that they’re easier to produce and less expensive. “There are picosecond lasers with middle wavelengths in the red light to near-infrared range (650-785 nm) that are better for darker skin types because they are more gentle yet still effective at targeting pigment, but these lasers are more expensive and less widely available,” Dr. Stankiewicz said.
“The microlens array, used in this study with the 532-nm wavelength, is an inexpensive piece that fits at the end of the laser,” she added. “So, to have an option that turns a 532-nm laser into a safer device for the treatment of lentigines in darker skin types is very helpful.”
Dr. Manuskiatti and Dr. Stankiewicz had no relevant disclosures to report.
A version of this article first appeared on Medscape.com.
BALTIMORE — Laser treatment for solar lentigines in individuals with darker skin types has long been associated with a higher risk of postinflammatory hyperpigmentation (PIH), but.
The study enrolled 27 patients with solar lentigines and Fitzpatrick skin types (FSTs) III-IV, Woraphong Manuskiatti, MD, professor of dermatology at Siriraj Hospital, Mahidol University, Bangkok, reported at the annual meeting of the American Society for Laser Medicine and Surgery. They received the fractional beam treatment on one side of the face and the full-beam on the other side. At 6 months, the incidence of PIH was about 81% lower on the fractional-beam side, Dr. Manuskiatti said.
“In the past, when we used laser to treat pigmented lesions, we used the so-called full-beam technique on the pigmented area,” Dr. Manuskiatti told this news organization. “From the study, we found that you don’t need to treat it at 100%. You can fractionally treat the pigmented lesion and get a really comparable treatment outcome and, at that reduced beam, less incidence of postinflammatory hyperpigmentation.”
Study Design and Results
Of the 27 patients in the study, 12 were FST III (44%), 14 were FST IV (52%), and one was FST V (4%). On the fractional-beam side, the laser was delivered through a 9-mm spot size with an average fluence of 0.47 J/cm² at a frequency of 2 Hz for a total of two passes without pulse overlapping. On the full-beam side, the laser was operated with a 4.5-mm handpiece, with fluence ranging from 0.3 to 0.7 J/cm² (using an endpoint of slight darkening of the pigmented lesion) at 2 Hz.
The patients received a single treatment and had a clinical evaluation and color reading assessments at 2 weeks, 1 month, 3 months, and 6 months after the treatment. Twenty-five patients completed the study.
The researchers found no statistically significant differences in lesional clearance between the two techniques at any of the follow-up assessments, Dr. Manuskiatti said. “This might be one of the alternative treatments of treating solar lentigines in dark-skinned patients,” he said when presenting the study results.
He reported the rates of PIH on the full-beam and fractional-beam sides, respectively, at the following intervals were: 64% and 8% at 2 weeks, 80% and 32% at 1 month, 96% and 36% at 3 months, and 88% and 16% at 6 months.
“The incidence of PIH on the full-beam side was statistically higher than that on the fractional-beam side throughout the follow-up period,” he said. Transient and mild hypopigmentation was observed in one patient (4%) on the fractional-beam side and in five (20%) on the full-beam side. Dr. Manuskiatti added that no other adverse effects were documented during the study.
“ Normally when you use laser to treat skin type I or II, you don’t have … PIH or darkening of the skin,” Dr. Manuskiatti told this news organization, “but when you have skin type III and above, you run into a really high incidence of postinflammatory hyperpigmentation — and treating that with fractional beam can lead to a reduced incidence of darkening of the skin afterward.”
A Lower-Cost Option
This study showed that the 532-nm picosecond laser with fractional beam MLA is a useful option for patients with darker skin types, Kelly Stankiewicz, MD, a dermatologist who practices in Park City, Utah, and moderated the session where these results were presented, told this news organization.
“The most challenging thing about treating lentigines in darker skin types is preventing potential side effects, mainly dyspigmentation,” she said after the meeting. “These side effects are, for the most part, temporary, but they can take 6-18 months to resolve, so it’s important to prevent them in the first place.”
She noted that the 532-nm and 1064-nm wavelengths are the most commonly available for picosecond lasers and that they’re easier to produce and less expensive. “There are picosecond lasers with middle wavelengths in the red light to near-infrared range (650-785 nm) that are better for darker skin types because they are more gentle yet still effective at targeting pigment, but these lasers are more expensive and less widely available,” Dr. Stankiewicz said.
“The microlens array, used in this study with the 532-nm wavelength, is an inexpensive piece that fits at the end of the laser,” she added. “So, to have an option that turns a 532-nm laser into a safer device for the treatment of lentigines in darker skin types is very helpful.”
Dr. Manuskiatti and Dr. Stankiewicz had no relevant disclosures to report.
A version of this article first appeared on Medscape.com.
BALTIMORE — Laser treatment for solar lentigines in individuals with darker skin types has long been associated with a higher risk of postinflammatory hyperpigmentation (PIH), but.
The study enrolled 27 patients with solar lentigines and Fitzpatrick skin types (FSTs) III-IV, Woraphong Manuskiatti, MD, professor of dermatology at Siriraj Hospital, Mahidol University, Bangkok, reported at the annual meeting of the American Society for Laser Medicine and Surgery. They received the fractional beam treatment on one side of the face and the full-beam on the other side. At 6 months, the incidence of PIH was about 81% lower on the fractional-beam side, Dr. Manuskiatti said.
“In the past, when we used laser to treat pigmented lesions, we used the so-called full-beam technique on the pigmented area,” Dr. Manuskiatti told this news organization. “From the study, we found that you don’t need to treat it at 100%. You can fractionally treat the pigmented lesion and get a really comparable treatment outcome and, at that reduced beam, less incidence of postinflammatory hyperpigmentation.”
Study Design and Results
Of the 27 patients in the study, 12 were FST III (44%), 14 were FST IV (52%), and one was FST V (4%). On the fractional-beam side, the laser was delivered through a 9-mm spot size with an average fluence of 0.47 J/cm² at a frequency of 2 Hz for a total of two passes without pulse overlapping. On the full-beam side, the laser was operated with a 4.5-mm handpiece, with fluence ranging from 0.3 to 0.7 J/cm² (using an endpoint of slight darkening of the pigmented lesion) at 2 Hz.
The patients received a single treatment and had a clinical evaluation and color reading assessments at 2 weeks, 1 month, 3 months, and 6 months after the treatment. Twenty-five patients completed the study.
The researchers found no statistically significant differences in lesional clearance between the two techniques at any of the follow-up assessments, Dr. Manuskiatti said. “This might be one of the alternative treatments of treating solar lentigines in dark-skinned patients,” he said when presenting the study results.
He reported the rates of PIH on the full-beam and fractional-beam sides, respectively, at the following intervals were: 64% and 8% at 2 weeks, 80% and 32% at 1 month, 96% and 36% at 3 months, and 88% and 16% at 6 months.
“The incidence of PIH on the full-beam side was statistically higher than that on the fractional-beam side throughout the follow-up period,” he said. Transient and mild hypopigmentation was observed in one patient (4%) on the fractional-beam side and in five (20%) on the full-beam side. Dr. Manuskiatti added that no other adverse effects were documented during the study.
“ Normally when you use laser to treat skin type I or II, you don’t have … PIH or darkening of the skin,” Dr. Manuskiatti told this news organization, “but when you have skin type III and above, you run into a really high incidence of postinflammatory hyperpigmentation — and treating that with fractional beam can lead to a reduced incidence of darkening of the skin afterward.”
A Lower-Cost Option
This study showed that the 532-nm picosecond laser with fractional beam MLA is a useful option for patients with darker skin types, Kelly Stankiewicz, MD, a dermatologist who practices in Park City, Utah, and moderated the session where these results were presented, told this news organization.
“The most challenging thing about treating lentigines in darker skin types is preventing potential side effects, mainly dyspigmentation,” she said after the meeting. “These side effects are, for the most part, temporary, but they can take 6-18 months to resolve, so it’s important to prevent them in the first place.”
She noted that the 532-nm and 1064-nm wavelengths are the most commonly available for picosecond lasers and that they’re easier to produce and less expensive. “There are picosecond lasers with middle wavelengths in the red light to near-infrared range (650-785 nm) that are better for darker skin types because they are more gentle yet still effective at targeting pigment, but these lasers are more expensive and less widely available,” Dr. Stankiewicz said.
“The microlens array, used in this study with the 532-nm wavelength, is an inexpensive piece that fits at the end of the laser,” she added. “So, to have an option that turns a 532-nm laser into a safer device for the treatment of lentigines in darker skin types is very helpful.”
Dr. Manuskiatti and Dr. Stankiewicz had no relevant disclosures to report.
A version of this article first appeared on Medscape.com.
FROM ASLMS 2024
Survey Finds Mental Health Issues Increased After Cosmetic Procedure Complications
BALTIMORE — of patients with dermatology-related complications.
The study used an anonymous 40-question survey circulated to a Facebook cosmetic complication support group. Seventy-one of 100 individuals completed the questionnaire, reporting significantly higher rates of mental health issues after their complications than before. Results were presented at the annual conference of the American Society for Laser Medicine and Surgery (ASLMS). Almost all the survey respondents (99%) were female, with 61% aged 25-44 years and 34% aged 45-64 years.
“Cosmetic procedures have increased over the past decade, with procedures being increasingly performed by an evolving variety of providers,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, Cleveland, Ohio, told this news organization. “Appropriate patient assessment and counseling and proper procedure technique are important for obtaining safe and effective results. Complications may not only impact patients physically but can also be harmful to their mental health.”
Rise in Mental Health Issues
The study found that before respondents had the treatment that led to their complications, 16% reported a history of generalized anxiety disorder, 15% a history of depression, and 1% a history of either BDD or PTSD. Following the complication, 50% reported a positive depression screening, 63% a positive BDD Questionnaire – Dermatology Version, and 63% a positive Primary Care PTSD screen, Dr. Murray said. “Almost half of respondents (46%) reported thinking about their complication for more than 3 hours a day,” she said in presenting the results.
Dr. Murray said the idea for the study grew out of her experience as a fellow working with Paul Friedman, MD, at the Dermatology and Laser Surgery Center at University of Texas Health in Houston.
“We were seeing a lot of complications,” Dr. Murray said in an interview. “Some of these were local. Some of these patients were flying in from out-of-state looking for help with the complication, and we could see what a mental and emotional burden this put on these patients. They were routinely in the office in tears saying it was interfering with their daily life, it was interfering with their job, saying they were going to lose their job, all because they were so distressed over what was happening to them.”
Yet, the research into psychological distress in patients with dermatologic complications is minimal, Dr. Murray added. “We think that body dysmorphic disorder is prevalent for patients seeking dermatology or plastic surgery services, but I don’t think either of the specialties do a great job in screening people for that when they come for treatment, so I think a lot of it goes undiagnosed. There’s been a trend looking at more at complications lately, but there’s been a gap in the literature.”
The treatments the patients in the survey had were microneedling with radiofrequency (29%), laser (24%), ultrasound for skin tightening (11%), radiofrequency for skin tightening (11%), microneedling (4%), chemical peel (3%), body contouring/sculpting (1%), and “other” (17%).
The study found that the largest share of procedures, 47%, were done by an esthetician/laser technician, followed by a nondermatologist physician (17%), a board-certified dermatologist (14%), an advanced practice provider (12%), and “other” (10%).
Self-reported complications included scarring (38%), hyperpigmentation (26%), erythema (24%), burn (23%), blisters (11%), and hypopigmentation (3%); 71% characterized their complications as “other,” and one respondent reported multiple complications.
“Respondents said they were satisfied with the previous cosmetic care they received,” Dr. Murray said during her presentation at the meeting. “And there was a consensus among the respondents that they did not feel adequately counseled on the risks of the procedure and that it did not meet their expectations and anticipated outcome.”
Take-Home Lesson
The lesson here is that practitioners who perform cosmetic procedures should be well-versed in the task and potential complications, Dr. Murray said in the interview. “If you’re going to be doing a procedure, make sure you know the proper techniques, the proper endpoints, and how to treat if you’re to have a complication,” she said. “If you don’t know how to treat a complication from the device, then you should think twice about using it.”
She also suggested screening patients for potentially undiagnosed mental health disorders. “It can play a role in the initial consultation and potentially any after-care they might need if there is a complication,” she said. “We may not have the adequate tools at this time to know how to best handle these patients and these scenarios, but hopefully my abstract will shed a little more light on it.”
She said she hopes her findings lead to more research in the future.
Asked to comment on the study, Jennifer Lin, MD, assistant professor of dermatology at Brigham and Women’s Hospital and Dana Farber Cancer Institute in Boston, Massachusetts, said one finding of the study stood out to her. “ I was very surprised from her dataset that patients think about it more than 3 hours a day,” she told this news organization. “That’s really significant. We talk about the side effects, but we don’t necessarily talk about the burden of how long the recovery will be or the psychological burden of potentially dealing with it.”
She noted that “there’s a bit of movement” toward developing guidelines for laser treatments, which would address the risk of complications. “That’s the goal: To have better guidelines to avoid these complications in the first place,” Dr. Lin said.
The study findings also point to a need for “premonitoring” individuals before procedures, she added. “We talked about patient selection and make sure someone doesn’t have body dysmorphic disorder, but we don’t formally screen for it,” she said. “We don’t our train our residents to screen for it. And I think doing more pre- and post-testing of how people are affected by laser treatment is going to become more important.”
Dr. Murray disclosed relationships with R2 Technologies. Dr. Lin had no relationships to disclose.
A version of this article appeared on Medscape.com.
BALTIMORE — of patients with dermatology-related complications.
The study used an anonymous 40-question survey circulated to a Facebook cosmetic complication support group. Seventy-one of 100 individuals completed the questionnaire, reporting significantly higher rates of mental health issues after their complications than before. Results were presented at the annual conference of the American Society for Laser Medicine and Surgery (ASLMS). Almost all the survey respondents (99%) were female, with 61% aged 25-44 years and 34% aged 45-64 years.
“Cosmetic procedures have increased over the past decade, with procedures being increasingly performed by an evolving variety of providers,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, Cleveland, Ohio, told this news organization. “Appropriate patient assessment and counseling and proper procedure technique are important for obtaining safe and effective results. Complications may not only impact patients physically but can also be harmful to their mental health.”
Rise in Mental Health Issues
The study found that before respondents had the treatment that led to their complications, 16% reported a history of generalized anxiety disorder, 15% a history of depression, and 1% a history of either BDD or PTSD. Following the complication, 50% reported a positive depression screening, 63% a positive BDD Questionnaire – Dermatology Version, and 63% a positive Primary Care PTSD screen, Dr. Murray said. “Almost half of respondents (46%) reported thinking about their complication for more than 3 hours a day,” she said in presenting the results.
Dr. Murray said the idea for the study grew out of her experience as a fellow working with Paul Friedman, MD, at the Dermatology and Laser Surgery Center at University of Texas Health in Houston.
“We were seeing a lot of complications,” Dr. Murray said in an interview. “Some of these were local. Some of these patients were flying in from out-of-state looking for help with the complication, and we could see what a mental and emotional burden this put on these patients. They were routinely in the office in tears saying it was interfering with their daily life, it was interfering with their job, saying they were going to lose their job, all because they were so distressed over what was happening to them.”
Yet, the research into psychological distress in patients with dermatologic complications is minimal, Dr. Murray added. “We think that body dysmorphic disorder is prevalent for patients seeking dermatology or plastic surgery services, but I don’t think either of the specialties do a great job in screening people for that when they come for treatment, so I think a lot of it goes undiagnosed. There’s been a trend looking at more at complications lately, but there’s been a gap in the literature.”
The treatments the patients in the survey had were microneedling with radiofrequency (29%), laser (24%), ultrasound for skin tightening (11%), radiofrequency for skin tightening (11%), microneedling (4%), chemical peel (3%), body contouring/sculpting (1%), and “other” (17%).
The study found that the largest share of procedures, 47%, were done by an esthetician/laser technician, followed by a nondermatologist physician (17%), a board-certified dermatologist (14%), an advanced practice provider (12%), and “other” (10%).
Self-reported complications included scarring (38%), hyperpigmentation (26%), erythema (24%), burn (23%), blisters (11%), and hypopigmentation (3%); 71% characterized their complications as “other,” and one respondent reported multiple complications.
“Respondents said they were satisfied with the previous cosmetic care they received,” Dr. Murray said during her presentation at the meeting. “And there was a consensus among the respondents that they did not feel adequately counseled on the risks of the procedure and that it did not meet their expectations and anticipated outcome.”
Take-Home Lesson
The lesson here is that practitioners who perform cosmetic procedures should be well-versed in the task and potential complications, Dr. Murray said in the interview. “If you’re going to be doing a procedure, make sure you know the proper techniques, the proper endpoints, and how to treat if you’re to have a complication,” she said. “If you don’t know how to treat a complication from the device, then you should think twice about using it.”
She also suggested screening patients for potentially undiagnosed mental health disorders. “It can play a role in the initial consultation and potentially any after-care they might need if there is a complication,” she said. “We may not have the adequate tools at this time to know how to best handle these patients and these scenarios, but hopefully my abstract will shed a little more light on it.”
She said she hopes her findings lead to more research in the future.
Asked to comment on the study, Jennifer Lin, MD, assistant professor of dermatology at Brigham and Women’s Hospital and Dana Farber Cancer Institute in Boston, Massachusetts, said one finding of the study stood out to her. “ I was very surprised from her dataset that patients think about it more than 3 hours a day,” she told this news organization. “That’s really significant. We talk about the side effects, but we don’t necessarily talk about the burden of how long the recovery will be or the psychological burden of potentially dealing with it.”
She noted that “there’s a bit of movement” toward developing guidelines for laser treatments, which would address the risk of complications. “That’s the goal: To have better guidelines to avoid these complications in the first place,” Dr. Lin said.
The study findings also point to a need for “premonitoring” individuals before procedures, she added. “We talked about patient selection and make sure someone doesn’t have body dysmorphic disorder, but we don’t formally screen for it,” she said. “We don’t our train our residents to screen for it. And I think doing more pre- and post-testing of how people are affected by laser treatment is going to become more important.”
Dr. Murray disclosed relationships with R2 Technologies. Dr. Lin had no relationships to disclose.
A version of this article appeared on Medscape.com.
BALTIMORE — of patients with dermatology-related complications.
The study used an anonymous 40-question survey circulated to a Facebook cosmetic complication support group. Seventy-one of 100 individuals completed the questionnaire, reporting significantly higher rates of mental health issues after their complications than before. Results were presented at the annual conference of the American Society for Laser Medicine and Surgery (ASLMS). Almost all the survey respondents (99%) were female, with 61% aged 25-44 years and 34% aged 45-64 years.
“Cosmetic procedures have increased over the past decade, with procedures being increasingly performed by an evolving variety of providers,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, Cleveland, Ohio, told this news organization. “Appropriate patient assessment and counseling and proper procedure technique are important for obtaining safe and effective results. Complications may not only impact patients physically but can also be harmful to their mental health.”
Rise in Mental Health Issues
The study found that before respondents had the treatment that led to their complications, 16% reported a history of generalized anxiety disorder, 15% a history of depression, and 1% a history of either BDD or PTSD. Following the complication, 50% reported a positive depression screening, 63% a positive BDD Questionnaire – Dermatology Version, and 63% a positive Primary Care PTSD screen, Dr. Murray said. “Almost half of respondents (46%) reported thinking about their complication for more than 3 hours a day,” she said in presenting the results.
Dr. Murray said the idea for the study grew out of her experience as a fellow working with Paul Friedman, MD, at the Dermatology and Laser Surgery Center at University of Texas Health in Houston.
“We were seeing a lot of complications,” Dr. Murray said in an interview. “Some of these were local. Some of these patients were flying in from out-of-state looking for help with the complication, and we could see what a mental and emotional burden this put on these patients. They were routinely in the office in tears saying it was interfering with their daily life, it was interfering with their job, saying they were going to lose their job, all because they were so distressed over what was happening to them.”
Yet, the research into psychological distress in patients with dermatologic complications is minimal, Dr. Murray added. “We think that body dysmorphic disorder is prevalent for patients seeking dermatology or plastic surgery services, but I don’t think either of the specialties do a great job in screening people for that when they come for treatment, so I think a lot of it goes undiagnosed. There’s been a trend looking at more at complications lately, but there’s been a gap in the literature.”
The treatments the patients in the survey had were microneedling with radiofrequency (29%), laser (24%), ultrasound for skin tightening (11%), radiofrequency for skin tightening (11%), microneedling (4%), chemical peel (3%), body contouring/sculpting (1%), and “other” (17%).
The study found that the largest share of procedures, 47%, were done by an esthetician/laser technician, followed by a nondermatologist physician (17%), a board-certified dermatologist (14%), an advanced practice provider (12%), and “other” (10%).
Self-reported complications included scarring (38%), hyperpigmentation (26%), erythema (24%), burn (23%), blisters (11%), and hypopigmentation (3%); 71% characterized their complications as “other,” and one respondent reported multiple complications.
“Respondents said they were satisfied with the previous cosmetic care they received,” Dr. Murray said during her presentation at the meeting. “And there was a consensus among the respondents that they did not feel adequately counseled on the risks of the procedure and that it did not meet their expectations and anticipated outcome.”
Take-Home Lesson
The lesson here is that practitioners who perform cosmetic procedures should be well-versed in the task and potential complications, Dr. Murray said in the interview. “If you’re going to be doing a procedure, make sure you know the proper techniques, the proper endpoints, and how to treat if you’re to have a complication,” she said. “If you don’t know how to treat a complication from the device, then you should think twice about using it.”
She also suggested screening patients for potentially undiagnosed mental health disorders. “It can play a role in the initial consultation and potentially any after-care they might need if there is a complication,” she said. “We may not have the adequate tools at this time to know how to best handle these patients and these scenarios, but hopefully my abstract will shed a little more light on it.”
She said she hopes her findings lead to more research in the future.
Asked to comment on the study, Jennifer Lin, MD, assistant professor of dermatology at Brigham and Women’s Hospital and Dana Farber Cancer Institute in Boston, Massachusetts, said one finding of the study stood out to her. “ I was very surprised from her dataset that patients think about it more than 3 hours a day,” she told this news organization. “That’s really significant. We talk about the side effects, but we don’t necessarily talk about the burden of how long the recovery will be or the psychological burden of potentially dealing with it.”
She noted that “there’s a bit of movement” toward developing guidelines for laser treatments, which would address the risk of complications. “That’s the goal: To have better guidelines to avoid these complications in the first place,” Dr. Lin said.
The study findings also point to a need for “premonitoring” individuals before procedures, she added. “We talked about patient selection and make sure someone doesn’t have body dysmorphic disorder, but we don’t formally screen for it,” she said. “We don’t our train our residents to screen for it. And I think doing more pre- and post-testing of how people are affected by laser treatment is going to become more important.”
Dr. Murray disclosed relationships with R2 Technologies. Dr. Lin had no relationships to disclose.
A version of this article appeared on Medscape.com.
FROM ASLMS 2024
Telemedicine Reduces Rehospitalization, Revascularization in Post-PCI ACS Patients
ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.
The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.
“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.”
The study findings were published online simultaneously in the Journal of the American College of Cardiology.
Telemedicine Protocol
The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead electrocardiogram belt, an automated blood-pressure monitor, and a pulse oximeter.
Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of cardiovascular risk factors.” Average age was 58.1 years.
If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.
Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.
Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, P < .001), unplanned coronary revascularizations (3% vs 9%, P < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, P < .01).
MACE rates were similar between the two groups.
At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.
The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (P < .001 for both).
Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.
Human Element Key
In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.
However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”
Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology.
“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”
While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”
The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.
A version of this article first appeared on Medscape.com.
ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.
The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.
“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.”
The study findings were published online simultaneously in the Journal of the American College of Cardiology.
Telemedicine Protocol
The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead electrocardiogram belt, an automated blood-pressure monitor, and a pulse oximeter.
Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of cardiovascular risk factors.” Average age was 58.1 years.
If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.
Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.
Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, P < .001), unplanned coronary revascularizations (3% vs 9%, P < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, P < .01).
MACE rates were similar between the two groups.
At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.
The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (P < .001 for both).
Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.
Human Element Key
In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.
However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”
Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology.
“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”
While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”
The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.
A version of this article first appeared on Medscape.com.
ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.
The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.
“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.”
The study findings were published online simultaneously in the Journal of the American College of Cardiology.
Telemedicine Protocol
The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead electrocardiogram belt, an automated blood-pressure monitor, and a pulse oximeter.
Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of cardiovascular risk factors.” Average age was 58.1 years.
If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.
Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.
Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, P < .001), unplanned coronary revascularizations (3% vs 9%, P < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, P < .01).
MACE rates were similar between the two groups.
At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.
The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (P < .001 for both).
Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.
Human Element Key
In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.
However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”
Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology.
“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”
While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”
The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Overlord or Underachiever: AI Poised to Disrupt Eye Care
You can’t spell “ophthalmologist” without artificial intelligence (AI) — a fact that might have many eye specialists looking warily over their shoulders. But should they be concerned, or is it time to embrace the new technology?
Ophthalmologists, like most other medical specialists, might be looking warily over their shoulders as AI continues to evolve. But should they be concerned, or is it time to embrace the new technology?
Two recent studies have demonstrated the ability of AI to match ophthalmologists’ answers to patients’ questions about eye disease, and the technology is poised to assist ophthalmologists in managing patient workflow and overcome shortages in the ophthalmic workforce, attendees at the American Glaucoma Society meeting presented on March 2, 2024, in Huntington Beach, California, were told.
A study at the Icahn School of Medicine at Mount Sinai in New York City found chatbots matched the proficiency of fellowship-trained ophthalmologists in diagnostic accuracy and completeness in handling questions about eye disease and real patient cases. Another study found a similar result in handling 200 eye care questions from an online chat forum, Robert Chang, MD, co-author of the second study and a glaucoma specialist and associate professor of ophthalmology at Stanford University in Stanford, California, reported.
“Using prompt engineering of ChatGPT, replies to patient online forum questions are becoming so realistic that specialist physicians are having difficulty telling the difference between human- and machine-generated responses,” Dr. Chang said.
The study used questions patients submitted to an online medical forum that received responses from ophthalmologists, then presented those responses plus answers generated by ChatGPT to a panel of eight ophthalmologists and asked them to distinguish between the two. “The accuracy of judging whether you could tell if it was written by AI or a human was about 61%,” Dr. Chang reported. “So most of the time you could not tell the difference.”
The study reported that of 800 evaluations of chatbot-written answers, ophthalmologists rated 21% of them as human-written, while they marked 64.6% of human-written answers as AI-written. The study also found that the likelihood of chatbot answers containing incorrect or inappropriate material was comparable with human answers: Less than 1% for both.
Dr. Chang also referenced a similar, more recent study from the Icahn School of Medicine in which 15 clinicians reviewed answers to patient questions by fellowship-trained glaucoma and retina specialists and those generated by ChatGPT-4, the chatbot model released by OpenAI in the spring of 2023. The study used a statistical tool to evaluate the combined question-case mean rank for accuracy, which was 506.2 for ChatGPT and 403.4 for glaucoma specialists based on 831 question cases. The mean rank for completeness was 528.3 and 398.7, respectively, based on 828 question cases (P < .001).
“The specialists themselves didn’t rate their answers as good as they rated the chatbot answers,” Dr. Chang said. “So it’s really showing that what we can come up with generative AI so human-like that it’s difficult for us to tell the difference on accuracy and completeness.”
‘Getting Close’
However, he noted that chatbots still have some kinks to work out with factual errors, difficulty referencing reliable sources, and hallucinations — fabricated material that may not be accurate. “We’re not quite there yet, but it’s getting close,” Dr. Chang added.
Dr. Chang noted that his clinic at Stanford is testing an AI platform to perform virtual scribing of patient encounters in real time. “That can save a lot of time on documentation,” he said. “I think this is a direction moving forward to increase our productivity because as we know, we all have workforce problems whether it’s the doctors or having enough technicians.”
Chatbots also are being tested for scheduling and generating letters. “Because of the unique needs of each ophthalmologist, AI agents that augment the existing workforce on specific administrative tasks will be the most likely early use case rather than autonomous disease screening or clinical decision support tools, which will take longer to validate prospectively in specific cohorts,” he said.
“Any AI today still has a long way to go before it can ingest and verify all the data for independent decision-making and be validated for fairness and generalizability,” Dr. Chang added. “It is much easier to have ‘low-level thinking’, repetitive tasks be taken care of by algorithms first.”
Dr. Chang “made a convincing case for embracing currently feasible applications of AI, highlighting the potential benefits of leveraging LLMs such as ChatGPT to enhance clinical productivity,” said Thasarat Vajaranant, MD, MHA, director of the glaucoma service and of data sourcing and strategy for the AI Ophthalmology Center at Illinois Eye and Ear Infirmary and the University of Illinois Chicago.
“With the growing demands of an aging population and workforce shortages in ophthalmology, AI-driven solutions offer promise in various areas, including telemedicine triage, organizing clinical notes, assisting in assessments and treatment planning, and virtual scribing,” Dr. Vajaranant said. “Rather than fearing this technology, we should approach its integration with caution.”
Dr. Chang disclosed relationships with Alcon, Genentech/Roche, Itnalight, Verana Health, Sight Sciences, Ocular Therapeutix, Glaukos, Carl Zeiss Meditec, and Apple. Dr. Vajaranant had no relevant disclosures.
A version of this article first appeared on Medscape.com.
You can’t spell “ophthalmologist” without artificial intelligence (AI) — a fact that might have many eye specialists looking warily over their shoulders. But should they be concerned, or is it time to embrace the new technology?
Ophthalmologists, like most other medical specialists, might be looking warily over their shoulders as AI continues to evolve. But should they be concerned, or is it time to embrace the new technology?
Two recent studies have demonstrated the ability of AI to match ophthalmologists’ answers to patients’ questions about eye disease, and the technology is poised to assist ophthalmologists in managing patient workflow and overcome shortages in the ophthalmic workforce, attendees at the American Glaucoma Society meeting presented on March 2, 2024, in Huntington Beach, California, were told.
A study at the Icahn School of Medicine at Mount Sinai in New York City found chatbots matched the proficiency of fellowship-trained ophthalmologists in diagnostic accuracy and completeness in handling questions about eye disease and real patient cases. Another study found a similar result in handling 200 eye care questions from an online chat forum, Robert Chang, MD, co-author of the second study and a glaucoma specialist and associate professor of ophthalmology at Stanford University in Stanford, California, reported.
“Using prompt engineering of ChatGPT, replies to patient online forum questions are becoming so realistic that specialist physicians are having difficulty telling the difference between human- and machine-generated responses,” Dr. Chang said.
The study used questions patients submitted to an online medical forum that received responses from ophthalmologists, then presented those responses plus answers generated by ChatGPT to a panel of eight ophthalmologists and asked them to distinguish between the two. “The accuracy of judging whether you could tell if it was written by AI or a human was about 61%,” Dr. Chang reported. “So most of the time you could not tell the difference.”
The study reported that of 800 evaluations of chatbot-written answers, ophthalmologists rated 21% of them as human-written, while they marked 64.6% of human-written answers as AI-written. The study also found that the likelihood of chatbot answers containing incorrect or inappropriate material was comparable with human answers: Less than 1% for both.
Dr. Chang also referenced a similar, more recent study from the Icahn School of Medicine in which 15 clinicians reviewed answers to patient questions by fellowship-trained glaucoma and retina specialists and those generated by ChatGPT-4, the chatbot model released by OpenAI in the spring of 2023. The study used a statistical tool to evaluate the combined question-case mean rank for accuracy, which was 506.2 for ChatGPT and 403.4 for glaucoma specialists based on 831 question cases. The mean rank for completeness was 528.3 and 398.7, respectively, based on 828 question cases (P < .001).
“The specialists themselves didn’t rate their answers as good as they rated the chatbot answers,” Dr. Chang said. “So it’s really showing that what we can come up with generative AI so human-like that it’s difficult for us to tell the difference on accuracy and completeness.”
‘Getting Close’
However, he noted that chatbots still have some kinks to work out with factual errors, difficulty referencing reliable sources, and hallucinations — fabricated material that may not be accurate. “We’re not quite there yet, but it’s getting close,” Dr. Chang added.
Dr. Chang noted that his clinic at Stanford is testing an AI platform to perform virtual scribing of patient encounters in real time. “That can save a lot of time on documentation,” he said. “I think this is a direction moving forward to increase our productivity because as we know, we all have workforce problems whether it’s the doctors or having enough technicians.”
Chatbots also are being tested for scheduling and generating letters. “Because of the unique needs of each ophthalmologist, AI agents that augment the existing workforce on specific administrative tasks will be the most likely early use case rather than autonomous disease screening or clinical decision support tools, which will take longer to validate prospectively in specific cohorts,” he said.
“Any AI today still has a long way to go before it can ingest and verify all the data for independent decision-making and be validated for fairness and generalizability,” Dr. Chang added. “It is much easier to have ‘low-level thinking’, repetitive tasks be taken care of by algorithms first.”
Dr. Chang “made a convincing case for embracing currently feasible applications of AI, highlighting the potential benefits of leveraging LLMs such as ChatGPT to enhance clinical productivity,” said Thasarat Vajaranant, MD, MHA, director of the glaucoma service and of data sourcing and strategy for the AI Ophthalmology Center at Illinois Eye and Ear Infirmary and the University of Illinois Chicago.
“With the growing demands of an aging population and workforce shortages in ophthalmology, AI-driven solutions offer promise in various areas, including telemedicine triage, organizing clinical notes, assisting in assessments and treatment planning, and virtual scribing,” Dr. Vajaranant said. “Rather than fearing this technology, we should approach its integration with caution.”
Dr. Chang disclosed relationships with Alcon, Genentech/Roche, Itnalight, Verana Health, Sight Sciences, Ocular Therapeutix, Glaukos, Carl Zeiss Meditec, and Apple. Dr. Vajaranant had no relevant disclosures.
A version of this article first appeared on Medscape.com.
You can’t spell “ophthalmologist” without artificial intelligence (AI) — a fact that might have many eye specialists looking warily over their shoulders. But should they be concerned, or is it time to embrace the new technology?
Ophthalmologists, like most other medical specialists, might be looking warily over their shoulders as AI continues to evolve. But should they be concerned, or is it time to embrace the new technology?
Two recent studies have demonstrated the ability of AI to match ophthalmologists’ answers to patients’ questions about eye disease, and the technology is poised to assist ophthalmologists in managing patient workflow and overcome shortages in the ophthalmic workforce, attendees at the American Glaucoma Society meeting presented on March 2, 2024, in Huntington Beach, California, were told.
A study at the Icahn School of Medicine at Mount Sinai in New York City found chatbots matched the proficiency of fellowship-trained ophthalmologists in diagnostic accuracy and completeness in handling questions about eye disease and real patient cases. Another study found a similar result in handling 200 eye care questions from an online chat forum, Robert Chang, MD, co-author of the second study and a glaucoma specialist and associate professor of ophthalmology at Stanford University in Stanford, California, reported.
“Using prompt engineering of ChatGPT, replies to patient online forum questions are becoming so realistic that specialist physicians are having difficulty telling the difference between human- and machine-generated responses,” Dr. Chang said.
The study used questions patients submitted to an online medical forum that received responses from ophthalmologists, then presented those responses plus answers generated by ChatGPT to a panel of eight ophthalmologists and asked them to distinguish between the two. “The accuracy of judging whether you could tell if it was written by AI or a human was about 61%,” Dr. Chang reported. “So most of the time you could not tell the difference.”
The study reported that of 800 evaluations of chatbot-written answers, ophthalmologists rated 21% of them as human-written, while they marked 64.6% of human-written answers as AI-written. The study also found that the likelihood of chatbot answers containing incorrect or inappropriate material was comparable with human answers: Less than 1% for both.
Dr. Chang also referenced a similar, more recent study from the Icahn School of Medicine in which 15 clinicians reviewed answers to patient questions by fellowship-trained glaucoma and retina specialists and those generated by ChatGPT-4, the chatbot model released by OpenAI in the spring of 2023. The study used a statistical tool to evaluate the combined question-case mean rank for accuracy, which was 506.2 for ChatGPT and 403.4 for glaucoma specialists based on 831 question cases. The mean rank for completeness was 528.3 and 398.7, respectively, based on 828 question cases (P < .001).
“The specialists themselves didn’t rate their answers as good as they rated the chatbot answers,” Dr. Chang said. “So it’s really showing that what we can come up with generative AI so human-like that it’s difficult for us to tell the difference on accuracy and completeness.”
‘Getting Close’
However, he noted that chatbots still have some kinks to work out with factual errors, difficulty referencing reliable sources, and hallucinations — fabricated material that may not be accurate. “We’re not quite there yet, but it’s getting close,” Dr. Chang added.
Dr. Chang noted that his clinic at Stanford is testing an AI platform to perform virtual scribing of patient encounters in real time. “That can save a lot of time on documentation,” he said. “I think this is a direction moving forward to increase our productivity because as we know, we all have workforce problems whether it’s the doctors or having enough technicians.”
Chatbots also are being tested for scheduling and generating letters. “Because of the unique needs of each ophthalmologist, AI agents that augment the existing workforce on specific administrative tasks will be the most likely early use case rather than autonomous disease screening or clinical decision support tools, which will take longer to validate prospectively in specific cohorts,” he said.
“Any AI today still has a long way to go before it can ingest and verify all the data for independent decision-making and be validated for fairness and generalizability,” Dr. Chang added. “It is much easier to have ‘low-level thinking’, repetitive tasks be taken care of by algorithms first.”
Dr. Chang “made a convincing case for embracing currently feasible applications of AI, highlighting the potential benefits of leveraging LLMs such as ChatGPT to enhance clinical productivity,” said Thasarat Vajaranant, MD, MHA, director of the glaucoma service and of data sourcing and strategy for the AI Ophthalmology Center at Illinois Eye and Ear Infirmary and the University of Illinois Chicago.
“With the growing demands of an aging population and workforce shortages in ophthalmology, AI-driven solutions offer promise in various areas, including telemedicine triage, organizing clinical notes, assisting in assessments and treatment planning, and virtual scribing,” Dr. Vajaranant said. “Rather than fearing this technology, we should approach its integration with caution.”
Dr. Chang disclosed relationships with Alcon, Genentech/Roche, Itnalight, Verana Health, Sight Sciences, Ocular Therapeutix, Glaukos, Carl Zeiss Meditec, and Apple. Dr. Vajaranant had no relevant disclosures.
A version of this article first appeared on Medscape.com.