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High cholesterol in seniors: Use statins for primary prevention?
LONG BEACH, CALIF. – For years, clinicians have debated whether prescribing statins to patients older than 75 for the prevention of cardiovascular events is appropriate.
In 2022, the U.S. Preventive Services Task Force concluded that scientific evidence was insufficient to assess the balance between the benefits and harms of the therapy for this older population.
At a session of the annual meeting of the American Geriatrics Society, experts laid out new preliminary recommendations of the AGS and the National Lipid Association on assessing risk and deciding on treatment.
The group concluded that LDL cholesterol levels are associated with incident arteriosclerotic cardiovascular disease (ASCVD), that the coronary artery calcium (CAC) score can be a valuable measure, and that statins may be reasonable to prescribe, even given the risks that have been linked to statins, such as that for muscle pain. Final recommendations are expected by fall 2023.
“This is still a work in progress,” said Daniel E. Forman, MD, professor of medicine and chair of geriatric cardiology at the University of Pittsburgh.
The AGS-NLA panel concluded that, for those aged 75 or older without established ASCVD, LDL cholesterol is associated with incident ASCVD, the only recommendation to be given a class I (strong) rating; others were classed as moderate or weak.
Dr. Forman reviewed the evidence for lowering LDL cholesterol to decrease ASCVD, citing a 2018 study that concluded, “Reverse causation may contribute to the association of lower TC with higher mortality in nonrandomized studies.”
However, research overall shows that, as LDL cholesterol levels increase, patients are more likely to experience a heart event.
Dr. Forman noted that the utility of equations for assessing 5- or 10-year risk of ASCVD is uncertain. However, he said, traditional risk factors, such as family history and ethnicity, still have value.
Assessing risk “has been enriched in the past few years by the introduction of the coronary artery calcium [CAC] score,” he said.
Lower scores predict lower rates of CVD events, Forman said. The AGS-NLA recommends measuring CAC if clinical uncertainty exists about the value of statins.
“It’s reasonable to measure CAC and to withhold statins when the CAC is zero,” Dr. Forman said. “When the CAC score is zero ... the risk of having a cardiovascular event is really next to nil. Patients are happy to know they have a CAC of zero.”
Likewise, patients appreciate knowing whether their score is high, which would indicate increased risk. He said the CAC score is underused by geriatric physicians.
The group also determined, after reviewing the research, that starting treatment is reasonable for patients with an LDL cholesterol level of 70-189 if they have no life-limiting illness and their life expectancy is over 5 years.
Other preliminary recommendations include the use of statins for those aged 75 and older, irrespective of risk for statin-associated muscle symptoms, type 2 diabetes, or impaired cognition. These associations are often weak, Dr. Forman added.
Focusing on person-centered decisions
Ariel Green, MD, MPH, PhD, associate professor of medicine at Johns Hopkins University, Baltimore, said statin therapy “should be individualized” to weigh benefits, noncardiac risks, and other considerations.
Clinicians can incorporate life expectancy into prevention decisions using tools such as ePrognosis, from the University of California, San Francisco, Dr. Green said.
If life expectancy is greater than the time to benefit, statin therapy may help. Dr. Green cited research that showed that 2.5 years of statin therapy was needed to prevent one major adverse cardiovascular event (MACE) per 100 patients in a population aged 50-75. Other data show reductions in MACE for those older than 75, but overall, the data are limited in this population.
The proposed recommendation is to use tools such as life tables that include comorbid conditions and functional status to guide clinical decisions.
“Another aspect of assessing net benefits of statin therapy is to consider competing health risks,” Dr. Green said.
The group recommends considering using competing risk-adjusted CVD models, though these are not widely used.
The group also recommends integrating screenings for frailty (Clinical Frailty Scale), dementia (Mini-Cog), and functional status (Vulnerable Elders Scale–13) into assessments.
“The presence of these syndromes should prompt elicitation of patient values and preferences related to prevention and medication use,” Dr. Green said.
Clinicians can use decision aids, but these are not always practical, owing to obstacles such as patients’ cognitive problems, Dr. Green said.
“Another approach is asking people to prioritize a set of universal health outcomes that apply across health conditions, such as maintaining independence, staying alive, reducing, or eliminating symptoms and focusing on comfort,” Dr. Green said.
She addressed the evidence about deprescribing statins, with a focus on those with a life expectancy of less than a year. Researchers have found an increase in quality of life and no increases in cardiovascular events or death when statins were deprescribed.
A welcome framework
Cory Krueger, MD, an internal medicine and geriatric physician in Cornville, Ariz., who attended the talk, said he welcomed the presentation, in which preliminary recommendations were explained.
“This has been a controversial area in geriatrics,” Dr. Krueger said. “At least this gave me a framework for discussing this with my patients in a reasonable way.”
Dr. Forman and Dr. Krueger disclosed no relevant financial relationships. Dr. Green receives funding from the National Institute of Aging and Impact Collaboratory.
A version of this article first appeared on Medscape.com.
LONG BEACH, CALIF. – For years, clinicians have debated whether prescribing statins to patients older than 75 for the prevention of cardiovascular events is appropriate.
In 2022, the U.S. Preventive Services Task Force concluded that scientific evidence was insufficient to assess the balance between the benefits and harms of the therapy for this older population.
At a session of the annual meeting of the American Geriatrics Society, experts laid out new preliminary recommendations of the AGS and the National Lipid Association on assessing risk and deciding on treatment.
The group concluded that LDL cholesterol levels are associated with incident arteriosclerotic cardiovascular disease (ASCVD), that the coronary artery calcium (CAC) score can be a valuable measure, and that statins may be reasonable to prescribe, even given the risks that have been linked to statins, such as that for muscle pain. Final recommendations are expected by fall 2023.
“This is still a work in progress,” said Daniel E. Forman, MD, professor of medicine and chair of geriatric cardiology at the University of Pittsburgh.
The AGS-NLA panel concluded that, for those aged 75 or older without established ASCVD, LDL cholesterol is associated with incident ASCVD, the only recommendation to be given a class I (strong) rating; others were classed as moderate or weak.
Dr. Forman reviewed the evidence for lowering LDL cholesterol to decrease ASCVD, citing a 2018 study that concluded, “Reverse causation may contribute to the association of lower TC with higher mortality in nonrandomized studies.”
However, research overall shows that, as LDL cholesterol levels increase, patients are more likely to experience a heart event.
Dr. Forman noted that the utility of equations for assessing 5- or 10-year risk of ASCVD is uncertain. However, he said, traditional risk factors, such as family history and ethnicity, still have value.
Assessing risk “has been enriched in the past few years by the introduction of the coronary artery calcium [CAC] score,” he said.
Lower scores predict lower rates of CVD events, Forman said. The AGS-NLA recommends measuring CAC if clinical uncertainty exists about the value of statins.
“It’s reasonable to measure CAC and to withhold statins when the CAC is zero,” Dr. Forman said. “When the CAC score is zero ... the risk of having a cardiovascular event is really next to nil. Patients are happy to know they have a CAC of zero.”
Likewise, patients appreciate knowing whether their score is high, which would indicate increased risk. He said the CAC score is underused by geriatric physicians.
The group also determined, after reviewing the research, that starting treatment is reasonable for patients with an LDL cholesterol level of 70-189 if they have no life-limiting illness and their life expectancy is over 5 years.
Other preliminary recommendations include the use of statins for those aged 75 and older, irrespective of risk for statin-associated muscle symptoms, type 2 diabetes, or impaired cognition. These associations are often weak, Dr. Forman added.
Focusing on person-centered decisions
Ariel Green, MD, MPH, PhD, associate professor of medicine at Johns Hopkins University, Baltimore, said statin therapy “should be individualized” to weigh benefits, noncardiac risks, and other considerations.
Clinicians can incorporate life expectancy into prevention decisions using tools such as ePrognosis, from the University of California, San Francisco, Dr. Green said.
If life expectancy is greater than the time to benefit, statin therapy may help. Dr. Green cited research that showed that 2.5 years of statin therapy was needed to prevent one major adverse cardiovascular event (MACE) per 100 patients in a population aged 50-75. Other data show reductions in MACE for those older than 75, but overall, the data are limited in this population.
The proposed recommendation is to use tools such as life tables that include comorbid conditions and functional status to guide clinical decisions.
“Another aspect of assessing net benefits of statin therapy is to consider competing health risks,” Dr. Green said.
The group recommends considering using competing risk-adjusted CVD models, though these are not widely used.
The group also recommends integrating screenings for frailty (Clinical Frailty Scale), dementia (Mini-Cog), and functional status (Vulnerable Elders Scale–13) into assessments.
“The presence of these syndromes should prompt elicitation of patient values and preferences related to prevention and medication use,” Dr. Green said.
Clinicians can use decision aids, but these are not always practical, owing to obstacles such as patients’ cognitive problems, Dr. Green said.
“Another approach is asking people to prioritize a set of universal health outcomes that apply across health conditions, such as maintaining independence, staying alive, reducing, or eliminating symptoms and focusing on comfort,” Dr. Green said.
She addressed the evidence about deprescribing statins, with a focus on those with a life expectancy of less than a year. Researchers have found an increase in quality of life and no increases in cardiovascular events or death when statins were deprescribed.
A welcome framework
Cory Krueger, MD, an internal medicine and geriatric physician in Cornville, Ariz., who attended the talk, said he welcomed the presentation, in which preliminary recommendations were explained.
“This has been a controversial area in geriatrics,” Dr. Krueger said. “At least this gave me a framework for discussing this with my patients in a reasonable way.”
Dr. Forman and Dr. Krueger disclosed no relevant financial relationships. Dr. Green receives funding from the National Institute of Aging and Impact Collaboratory.
A version of this article first appeared on Medscape.com.
LONG BEACH, CALIF. – For years, clinicians have debated whether prescribing statins to patients older than 75 for the prevention of cardiovascular events is appropriate.
In 2022, the U.S. Preventive Services Task Force concluded that scientific evidence was insufficient to assess the balance between the benefits and harms of the therapy for this older population.
At a session of the annual meeting of the American Geriatrics Society, experts laid out new preliminary recommendations of the AGS and the National Lipid Association on assessing risk and deciding on treatment.
The group concluded that LDL cholesterol levels are associated with incident arteriosclerotic cardiovascular disease (ASCVD), that the coronary artery calcium (CAC) score can be a valuable measure, and that statins may be reasonable to prescribe, even given the risks that have been linked to statins, such as that for muscle pain. Final recommendations are expected by fall 2023.
“This is still a work in progress,” said Daniel E. Forman, MD, professor of medicine and chair of geriatric cardiology at the University of Pittsburgh.
The AGS-NLA panel concluded that, for those aged 75 or older without established ASCVD, LDL cholesterol is associated with incident ASCVD, the only recommendation to be given a class I (strong) rating; others were classed as moderate or weak.
Dr. Forman reviewed the evidence for lowering LDL cholesterol to decrease ASCVD, citing a 2018 study that concluded, “Reverse causation may contribute to the association of lower TC with higher mortality in nonrandomized studies.”
However, research overall shows that, as LDL cholesterol levels increase, patients are more likely to experience a heart event.
Dr. Forman noted that the utility of equations for assessing 5- or 10-year risk of ASCVD is uncertain. However, he said, traditional risk factors, such as family history and ethnicity, still have value.
Assessing risk “has been enriched in the past few years by the introduction of the coronary artery calcium [CAC] score,” he said.
Lower scores predict lower rates of CVD events, Forman said. The AGS-NLA recommends measuring CAC if clinical uncertainty exists about the value of statins.
“It’s reasonable to measure CAC and to withhold statins when the CAC is zero,” Dr. Forman said. “When the CAC score is zero ... the risk of having a cardiovascular event is really next to nil. Patients are happy to know they have a CAC of zero.”
Likewise, patients appreciate knowing whether their score is high, which would indicate increased risk. He said the CAC score is underused by geriatric physicians.
The group also determined, after reviewing the research, that starting treatment is reasonable for patients with an LDL cholesterol level of 70-189 if they have no life-limiting illness and their life expectancy is over 5 years.
Other preliminary recommendations include the use of statins for those aged 75 and older, irrespective of risk for statin-associated muscle symptoms, type 2 diabetes, or impaired cognition. These associations are often weak, Dr. Forman added.
Focusing on person-centered decisions
Ariel Green, MD, MPH, PhD, associate professor of medicine at Johns Hopkins University, Baltimore, said statin therapy “should be individualized” to weigh benefits, noncardiac risks, and other considerations.
Clinicians can incorporate life expectancy into prevention decisions using tools such as ePrognosis, from the University of California, San Francisco, Dr. Green said.
If life expectancy is greater than the time to benefit, statin therapy may help. Dr. Green cited research that showed that 2.5 years of statin therapy was needed to prevent one major adverse cardiovascular event (MACE) per 100 patients in a population aged 50-75. Other data show reductions in MACE for those older than 75, but overall, the data are limited in this population.
The proposed recommendation is to use tools such as life tables that include comorbid conditions and functional status to guide clinical decisions.
“Another aspect of assessing net benefits of statin therapy is to consider competing health risks,” Dr. Green said.
The group recommends considering using competing risk-adjusted CVD models, though these are not widely used.
The group also recommends integrating screenings for frailty (Clinical Frailty Scale), dementia (Mini-Cog), and functional status (Vulnerable Elders Scale–13) into assessments.
“The presence of these syndromes should prompt elicitation of patient values and preferences related to prevention and medication use,” Dr. Green said.
Clinicians can use decision aids, but these are not always practical, owing to obstacles such as patients’ cognitive problems, Dr. Green said.
“Another approach is asking people to prioritize a set of universal health outcomes that apply across health conditions, such as maintaining independence, staying alive, reducing, or eliminating symptoms and focusing on comfort,” Dr. Green said.
She addressed the evidence about deprescribing statins, with a focus on those with a life expectancy of less than a year. Researchers have found an increase in quality of life and no increases in cardiovascular events or death when statins were deprescribed.
A welcome framework
Cory Krueger, MD, an internal medicine and geriatric physician in Cornville, Ariz., who attended the talk, said he welcomed the presentation, in which preliminary recommendations were explained.
“This has been a controversial area in geriatrics,” Dr. Krueger said. “At least this gave me a framework for discussing this with my patients in a reasonable way.”
Dr. Forman and Dr. Krueger disclosed no relevant financial relationships. Dr. Green receives funding from the National Institute of Aging and Impact Collaboratory.
A version of this article first appeared on Medscape.com.
AT AGS 2023
Can this tool forecast peanut allergies?
Pediatricians may have a new aid to better predict peanut allergies among infants with atopic dermatitis.
Their study of the implementation of the scorecard was presented at the Pediatric Academic Societies annual meeting.
Infants with atopic dermatitis or eczema are six times more likely to have an egg allergy and eleven times more likely to have a peanut allergy at age 12 months than are infants without atopic dermatitis.
The scorecard reflects recent directives from the National Institute of Allergy and Infectious Diseases to help combat the public health problem.
“When the NIAID prevention of peanut allergy guidelines first came out, it asked pediatricians to serve as frontline practitioners in implementing them by identifying children at risk for peanut allergy and guiding families on what to do next,” said Waheeda Samady, MD, professor of pediatrics at Northwestern University, Chicago. “The impetus for the study was to further support pediatricians in this role.”
Although pediatricians are trained to identify and even treat mild to moderate cases of atopic dermatitis, little emphasis has gone to categorizing the condition on the basis of severity and to correlating peanut allergy risk.
The predictive scorecard captures 14 images from one infant of mixed race, two White infants, two Black infants, and two Hispanic infants.
To create the card, two in-house pediatric dermatologists assessed 58 images from 13 children and categorized images from 0 (no signs of atopic dermatitis) to 4 (severe signs of atopic dermatitis). After a first pass on categorization, the doctors agreed on 84% of images.
Of 189 pediatricians who used the card, fewer than half reported that they “sometimes,” “very often,” or “always” used the scorecard for atopic dermatitis evaluation. A little fewer than three-quarters reported that their ability to diagnose and categorize atopic dermatitis improved.
“Severity staging of atopic dermatitis is not something that the general pediatrician necessarily performs on a day-to-day basis,” said Kawaljit Brar, MD, professor of pediatrics in the division of allergy and immunology at Hassenfeld Children’s Hospital in New York.
Dr. Brar explained that children who are identified as being at high risk are often referred to specialists such as her, who then perform allergy screenings and can determine whether introduction of food at home is safe or whether office feedings supervised by an allergist are necessary. Researchers have found that early introduction to peanuts for children with moderate to severe atopic dermatitis could prevent peanut allergy.
“This represents a wonderful initiative to educate pediatricians so that they understand which patients require screening for peanut allergy and which patients don’t and can just get introduced to peanuts at home,” Dr. Brar said.
The atopic dermatitis scorecard reflects a growing recognition that varying skin tones show levels of severity incongruously.
“Many of us in clinical practice have recognized that our education has not always been inclusive of patients with varying skin tones,” Dr. Samady said. “When we looked for photos of patients with different skin tones, we simply could not find any that we thought were appropriate. So we decided to take some ourselves, and we’re currently continuing to take photos in order to improve the scorecard we currently have.”
The study was funded by the National Institute of Health and Food Allergy Research and Education. Dr. Samady and Dr. Brar reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pediatricians may have a new aid to better predict peanut allergies among infants with atopic dermatitis.
Their study of the implementation of the scorecard was presented at the Pediatric Academic Societies annual meeting.
Infants with atopic dermatitis or eczema are six times more likely to have an egg allergy and eleven times more likely to have a peanut allergy at age 12 months than are infants without atopic dermatitis.
The scorecard reflects recent directives from the National Institute of Allergy and Infectious Diseases to help combat the public health problem.
“When the NIAID prevention of peanut allergy guidelines first came out, it asked pediatricians to serve as frontline practitioners in implementing them by identifying children at risk for peanut allergy and guiding families on what to do next,” said Waheeda Samady, MD, professor of pediatrics at Northwestern University, Chicago. “The impetus for the study was to further support pediatricians in this role.”
Although pediatricians are trained to identify and even treat mild to moderate cases of atopic dermatitis, little emphasis has gone to categorizing the condition on the basis of severity and to correlating peanut allergy risk.
The predictive scorecard captures 14 images from one infant of mixed race, two White infants, two Black infants, and two Hispanic infants.
To create the card, two in-house pediatric dermatologists assessed 58 images from 13 children and categorized images from 0 (no signs of atopic dermatitis) to 4 (severe signs of atopic dermatitis). After a first pass on categorization, the doctors agreed on 84% of images.
Of 189 pediatricians who used the card, fewer than half reported that they “sometimes,” “very often,” or “always” used the scorecard for atopic dermatitis evaluation. A little fewer than three-quarters reported that their ability to diagnose and categorize atopic dermatitis improved.
“Severity staging of atopic dermatitis is not something that the general pediatrician necessarily performs on a day-to-day basis,” said Kawaljit Brar, MD, professor of pediatrics in the division of allergy and immunology at Hassenfeld Children’s Hospital in New York.
Dr. Brar explained that children who are identified as being at high risk are often referred to specialists such as her, who then perform allergy screenings and can determine whether introduction of food at home is safe or whether office feedings supervised by an allergist are necessary. Researchers have found that early introduction to peanuts for children with moderate to severe atopic dermatitis could prevent peanut allergy.
“This represents a wonderful initiative to educate pediatricians so that they understand which patients require screening for peanut allergy and which patients don’t and can just get introduced to peanuts at home,” Dr. Brar said.
The atopic dermatitis scorecard reflects a growing recognition that varying skin tones show levels of severity incongruously.
“Many of us in clinical practice have recognized that our education has not always been inclusive of patients with varying skin tones,” Dr. Samady said. “When we looked for photos of patients with different skin tones, we simply could not find any that we thought were appropriate. So we decided to take some ourselves, and we’re currently continuing to take photos in order to improve the scorecard we currently have.”
The study was funded by the National Institute of Health and Food Allergy Research and Education. Dr. Samady and Dr. Brar reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pediatricians may have a new aid to better predict peanut allergies among infants with atopic dermatitis.
Their study of the implementation of the scorecard was presented at the Pediatric Academic Societies annual meeting.
Infants with atopic dermatitis or eczema are six times more likely to have an egg allergy and eleven times more likely to have a peanut allergy at age 12 months than are infants without atopic dermatitis.
The scorecard reflects recent directives from the National Institute of Allergy and Infectious Diseases to help combat the public health problem.
“When the NIAID prevention of peanut allergy guidelines first came out, it asked pediatricians to serve as frontline practitioners in implementing them by identifying children at risk for peanut allergy and guiding families on what to do next,” said Waheeda Samady, MD, professor of pediatrics at Northwestern University, Chicago. “The impetus for the study was to further support pediatricians in this role.”
Although pediatricians are trained to identify and even treat mild to moderate cases of atopic dermatitis, little emphasis has gone to categorizing the condition on the basis of severity and to correlating peanut allergy risk.
The predictive scorecard captures 14 images from one infant of mixed race, two White infants, two Black infants, and two Hispanic infants.
To create the card, two in-house pediatric dermatologists assessed 58 images from 13 children and categorized images from 0 (no signs of atopic dermatitis) to 4 (severe signs of atopic dermatitis). After a first pass on categorization, the doctors agreed on 84% of images.
Of 189 pediatricians who used the card, fewer than half reported that they “sometimes,” “very often,” or “always” used the scorecard for atopic dermatitis evaluation. A little fewer than three-quarters reported that their ability to diagnose and categorize atopic dermatitis improved.
“Severity staging of atopic dermatitis is not something that the general pediatrician necessarily performs on a day-to-day basis,” said Kawaljit Brar, MD, professor of pediatrics in the division of allergy and immunology at Hassenfeld Children’s Hospital in New York.
Dr. Brar explained that children who are identified as being at high risk are often referred to specialists such as her, who then perform allergy screenings and can determine whether introduction of food at home is safe or whether office feedings supervised by an allergist are necessary. Researchers have found that early introduction to peanuts for children with moderate to severe atopic dermatitis could prevent peanut allergy.
“This represents a wonderful initiative to educate pediatricians so that they understand which patients require screening for peanut allergy and which patients don’t and can just get introduced to peanuts at home,” Dr. Brar said.
The atopic dermatitis scorecard reflects a growing recognition that varying skin tones show levels of severity incongruously.
“Many of us in clinical practice have recognized that our education has not always been inclusive of patients with varying skin tones,” Dr. Samady said. “When we looked for photos of patients with different skin tones, we simply could not find any that we thought were appropriate. So we decided to take some ourselves, and we’re currently continuing to take photos in order to improve the scorecard we currently have.”
The study was funded by the National Institute of Health and Food Allergy Research and Education. Dr. Samady and Dr. Brar reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM PAS 2023
Picosecond laser applications continue to expand
PHOENIX – Ever since PicoSure became the first picosecond laser cleared by the Food and Drug Administration for the treatment of unwanted tattoos and pigmented lesions in 2012, new uses for this technology continue to expand.
Now, These include PicoWay, PicoSure, Enlighten, PicoPlus, PiQo4, and Quanta Pico, among others.
“PicoWay technology has integrated nicely into my practice in Houston, the most ethnically diverse city in the country, with its ability to safely treat a number of various benign, congenital, and acquired epidermal and dermal pigmented lesions with ultrashort pulse duration and low thermal impact, which greatly reduces the risk of postinflammatory hyperpigmentation even in darker skin types,” Paul M. Friedman, MD, director of the Dermatology and Laser Surgery Center, Houston, said at the annual conference of the American Society for Laser Medicine and Surgery.
He emphasized the importance of therapeutic clinical endpoints, noting that with q-switched lasers, “you’re looking for immediate whitening, whereas with picosecond lasers, your endpoint is slight whitening or slight darkening depending on wavelength, indication, and skin type. The ability to fractionate picosecond pulses has also allowed us to utilize this technology for photoaging as well as acne scarring.”
The PicoWay system includes a 730-nm picosecond titanium sapphire handpiece, which is FDA cleared for treatment of benign pigmented lesions and blue and green tattoo removal. Dr. Friedman said that he has seen good clinical results using the handpiece for café-au-lait macules, particularly in skin of color.
In an abstract presented at the ASLMS meeting, he and his colleagues presented a retrospective review of 12 patients with café-au-lait macules with Fitzpatrick skin types III-VI who were treated with the PicoWay 730 nm handpiece between April 2021 and January 2023. Patients received a mean of 3.1 treatments at intervals that ranged from 5 to 40 weeks. Clinical photographs were graded by three board-certified dermatologists using a 5-point visual analogue scale.
Overall, patients were rated to have a mean improvement of 26%-50%. Two patients achieved 100% clearance after four to five treatment sessions. “Café-au-lait macules with smooth borders responded less well to laser treatment, confirming prior studies at our center,” he said. “We often educate parents that café-au-lait macules may recur over time, especially with repeated sun exposure.”
Treating melasma
Dr. Friedman’s go-to devices for melasma include the low-density, low-energy 1,927-nm fractional diode laser; the 1,064 nm picosecond Nd:YAG, the low-fluence 1,064 nm Q-switched Nd:YAG with a nanosecond pulse duration, and the 595-nm pulsed dye laser for lesions exhibiting underlying vascularity. He said that combining therapies that target pigment and vasculature may be ideal to prevent relapses. “Melasma is a multifactorial condition so by improving patient education and expectation alongside advances in laser treatment of melasma, we have ultimately improved our ability to treat this condition,” he said.
“We’re approaching it from all angles, with ultraviolet photography and spectrocolorimetry, behavioral modifications, topical skin-lightening agents, broad spectrum sunscreens with protection against visible light, and oral tranexamic acid in advanced cases. Then, we intervene with these energy-based modalities, and the bottom line is, less energy and density is more, with lengthened treatment intervals. In 2023, we’re better than we’ve ever been in terms of our ability to safely and effectively improve melasma.”
Novel lasers
Dr. Friedman also described the UltraClear, a novel ablative fractional 2,910-nm erbium-doped glass fiber laser that delivers a customized blend of ablation and coagulation based on the patient’s condition, skin type, and tolerability for down time. He provided an overview of the versatility of what he described as highly customizable technology for conditions such as photoaging and dyschromia in patients of various skin types, making it a very versatile platform in his practice.
The AVAVA MIRIA system is a “next generation” laser “where you’re able to use a focal point. Basically, you’re treating the skin from the inside out in a 3D manner and you’re able to focus intradermally up to 1 mm with high energy 1,064 nm or 1,550 nm,” he said. “It’s a unique conical geometry that spares the epidermis, combined with sapphire tip cooling and images the skin at the same time with the potential for personalized treatments of dyschromia and photoaging in all skin types. It’s truly remarkable where the technology is heading.”
Dr. Friedman disclosed that he has received consulting fees from Allergan, Galderma, Acclaro, Merz Aesthetics, Solta Medical, and Cytrellis. He has conducted contracted research for Sofwave and is a member of the speakers bureau for Solta Medical and Candela.
PHOENIX – Ever since PicoSure became the first picosecond laser cleared by the Food and Drug Administration for the treatment of unwanted tattoos and pigmented lesions in 2012, new uses for this technology continue to expand.
Now, These include PicoWay, PicoSure, Enlighten, PicoPlus, PiQo4, and Quanta Pico, among others.
“PicoWay technology has integrated nicely into my practice in Houston, the most ethnically diverse city in the country, with its ability to safely treat a number of various benign, congenital, and acquired epidermal and dermal pigmented lesions with ultrashort pulse duration and low thermal impact, which greatly reduces the risk of postinflammatory hyperpigmentation even in darker skin types,” Paul M. Friedman, MD, director of the Dermatology and Laser Surgery Center, Houston, said at the annual conference of the American Society for Laser Medicine and Surgery.
He emphasized the importance of therapeutic clinical endpoints, noting that with q-switched lasers, “you’re looking for immediate whitening, whereas with picosecond lasers, your endpoint is slight whitening or slight darkening depending on wavelength, indication, and skin type. The ability to fractionate picosecond pulses has also allowed us to utilize this technology for photoaging as well as acne scarring.”
The PicoWay system includes a 730-nm picosecond titanium sapphire handpiece, which is FDA cleared for treatment of benign pigmented lesions and blue and green tattoo removal. Dr. Friedman said that he has seen good clinical results using the handpiece for café-au-lait macules, particularly in skin of color.
In an abstract presented at the ASLMS meeting, he and his colleagues presented a retrospective review of 12 patients with café-au-lait macules with Fitzpatrick skin types III-VI who were treated with the PicoWay 730 nm handpiece between April 2021 and January 2023. Patients received a mean of 3.1 treatments at intervals that ranged from 5 to 40 weeks. Clinical photographs were graded by three board-certified dermatologists using a 5-point visual analogue scale.
Overall, patients were rated to have a mean improvement of 26%-50%. Two patients achieved 100% clearance after four to five treatment sessions. “Café-au-lait macules with smooth borders responded less well to laser treatment, confirming prior studies at our center,” he said. “We often educate parents that café-au-lait macules may recur over time, especially with repeated sun exposure.”
Treating melasma
Dr. Friedman’s go-to devices for melasma include the low-density, low-energy 1,927-nm fractional diode laser; the 1,064 nm picosecond Nd:YAG, the low-fluence 1,064 nm Q-switched Nd:YAG with a nanosecond pulse duration, and the 595-nm pulsed dye laser for lesions exhibiting underlying vascularity. He said that combining therapies that target pigment and vasculature may be ideal to prevent relapses. “Melasma is a multifactorial condition so by improving patient education and expectation alongside advances in laser treatment of melasma, we have ultimately improved our ability to treat this condition,” he said.
“We’re approaching it from all angles, with ultraviolet photography and spectrocolorimetry, behavioral modifications, topical skin-lightening agents, broad spectrum sunscreens with protection against visible light, and oral tranexamic acid in advanced cases. Then, we intervene with these energy-based modalities, and the bottom line is, less energy and density is more, with lengthened treatment intervals. In 2023, we’re better than we’ve ever been in terms of our ability to safely and effectively improve melasma.”
Novel lasers
Dr. Friedman also described the UltraClear, a novel ablative fractional 2,910-nm erbium-doped glass fiber laser that delivers a customized blend of ablation and coagulation based on the patient’s condition, skin type, and tolerability for down time. He provided an overview of the versatility of what he described as highly customizable technology for conditions such as photoaging and dyschromia in patients of various skin types, making it a very versatile platform in his practice.
The AVAVA MIRIA system is a “next generation” laser “where you’re able to use a focal point. Basically, you’re treating the skin from the inside out in a 3D manner and you’re able to focus intradermally up to 1 mm with high energy 1,064 nm or 1,550 nm,” he said. “It’s a unique conical geometry that spares the epidermis, combined with sapphire tip cooling and images the skin at the same time with the potential for personalized treatments of dyschromia and photoaging in all skin types. It’s truly remarkable where the technology is heading.”
Dr. Friedman disclosed that he has received consulting fees from Allergan, Galderma, Acclaro, Merz Aesthetics, Solta Medical, and Cytrellis. He has conducted contracted research for Sofwave and is a member of the speakers bureau for Solta Medical and Candela.
PHOENIX – Ever since PicoSure became the first picosecond laser cleared by the Food and Drug Administration for the treatment of unwanted tattoos and pigmented lesions in 2012, new uses for this technology continue to expand.
Now, These include PicoWay, PicoSure, Enlighten, PicoPlus, PiQo4, and Quanta Pico, among others.
“PicoWay technology has integrated nicely into my practice in Houston, the most ethnically diverse city in the country, with its ability to safely treat a number of various benign, congenital, and acquired epidermal and dermal pigmented lesions with ultrashort pulse duration and low thermal impact, which greatly reduces the risk of postinflammatory hyperpigmentation even in darker skin types,” Paul M. Friedman, MD, director of the Dermatology and Laser Surgery Center, Houston, said at the annual conference of the American Society for Laser Medicine and Surgery.
He emphasized the importance of therapeutic clinical endpoints, noting that with q-switched lasers, “you’re looking for immediate whitening, whereas with picosecond lasers, your endpoint is slight whitening or slight darkening depending on wavelength, indication, and skin type. The ability to fractionate picosecond pulses has also allowed us to utilize this technology for photoaging as well as acne scarring.”
The PicoWay system includes a 730-nm picosecond titanium sapphire handpiece, which is FDA cleared for treatment of benign pigmented lesions and blue and green tattoo removal. Dr. Friedman said that he has seen good clinical results using the handpiece for café-au-lait macules, particularly in skin of color.
In an abstract presented at the ASLMS meeting, he and his colleagues presented a retrospective review of 12 patients with café-au-lait macules with Fitzpatrick skin types III-VI who were treated with the PicoWay 730 nm handpiece between April 2021 and January 2023. Patients received a mean of 3.1 treatments at intervals that ranged from 5 to 40 weeks. Clinical photographs were graded by three board-certified dermatologists using a 5-point visual analogue scale.
Overall, patients were rated to have a mean improvement of 26%-50%. Two patients achieved 100% clearance after four to five treatment sessions. “Café-au-lait macules with smooth borders responded less well to laser treatment, confirming prior studies at our center,” he said. “We often educate parents that café-au-lait macules may recur over time, especially with repeated sun exposure.”
Treating melasma
Dr. Friedman’s go-to devices for melasma include the low-density, low-energy 1,927-nm fractional diode laser; the 1,064 nm picosecond Nd:YAG, the low-fluence 1,064 nm Q-switched Nd:YAG with a nanosecond pulse duration, and the 595-nm pulsed dye laser for lesions exhibiting underlying vascularity. He said that combining therapies that target pigment and vasculature may be ideal to prevent relapses. “Melasma is a multifactorial condition so by improving patient education and expectation alongside advances in laser treatment of melasma, we have ultimately improved our ability to treat this condition,” he said.
“We’re approaching it from all angles, with ultraviolet photography and spectrocolorimetry, behavioral modifications, topical skin-lightening agents, broad spectrum sunscreens with protection against visible light, and oral tranexamic acid in advanced cases. Then, we intervene with these energy-based modalities, and the bottom line is, less energy and density is more, with lengthened treatment intervals. In 2023, we’re better than we’ve ever been in terms of our ability to safely and effectively improve melasma.”
Novel lasers
Dr. Friedman also described the UltraClear, a novel ablative fractional 2,910-nm erbium-doped glass fiber laser that delivers a customized blend of ablation and coagulation based on the patient’s condition, skin type, and tolerability for down time. He provided an overview of the versatility of what he described as highly customizable technology for conditions such as photoaging and dyschromia in patients of various skin types, making it a very versatile platform in his practice.
The AVAVA MIRIA system is a “next generation” laser “where you’re able to use a focal point. Basically, you’re treating the skin from the inside out in a 3D manner and you’re able to focus intradermally up to 1 mm with high energy 1,064 nm or 1,550 nm,” he said. “It’s a unique conical geometry that spares the epidermis, combined with sapphire tip cooling and images the skin at the same time with the potential for personalized treatments of dyschromia and photoaging in all skin types. It’s truly remarkable where the technology is heading.”
Dr. Friedman disclosed that he has received consulting fees from Allergan, Galderma, Acclaro, Merz Aesthetics, Solta Medical, and Cytrellis. He has conducted contracted research for Sofwave and is a member of the speakers bureau for Solta Medical and Candela.
FROM ASLMS 2023
Bundled strategy increased preteen lipid screening
WASHINGTON – A bundled intervention combining point-of-care testing, electronic medical record support, and provider education significantly improved lipid screening rates in children aged 9-11 years, according to data from approximately 100 monthly visits over a 3-year period.
Guidelines from the National Heart, Lung, and Blood Institute currently recommend universal lipid screening for children aged 9-11 years, but screening rates in clinical practice remain low, according to Ruth E. Gardner, MD, of Penn State University, Hershey, and colleagues.
In a poster presented at the Pediatric Academic Societies annual meeting, Dr. Gardner and colleagues shared results of the implementation of a bundled testing protocol designed to improve screening.
The researchers reviewed data on lipid testing within 30 days for all 9- to 11-year-old well child visits at a single center between May 2019 and February 2022. The bundled intervention was introduced in May 2021.
The bundled protocol included in-office capillary testing and provider education. In addition, electronic medical record templates were modified to include prompts for lipid screening at relevant ages, and EMR orders were adjusted to include lipid testing. The researchers also collected targeted provider feedback on individualized screening rates in February 2022.
Screening rates were plotted monthly. For the period from May 2019 through May 2021, the rates averaged 6.5%. However, after the introduction of the bundled intervention, the rate increased to 29.9%. Following targeted provider feedback in February 2022, the researchers found an additional shift to 52.1% through March and April 2022.
The findings were limited by the use of data from a single center, and the researchers used an extended study period to account for disruptions to well-child care in the spring of 2020 related to the COVID-19 pandemic.
However, the results support the effectiveness of a bundled intervention for improving lipid screening rates in children aged 9-11 years, the researchers said, and targeted provider feedback and education could yield additional improvements, they concluded.
Preteen years are an optimal time for screening
“The current study is important because atherosclerosis begins in childhood, and screening at ages 9-11 is an optimal time to begin lifestyle changes to improve overall health and reduce risks of heart disease,” said Margaret Thew, DNP, FNP-BC, of the Medical College of Wisconsin, Milwaukee, in an interview.
Ms. Thew, who was not involved in the study, said, “The number of recommended and required screening items needed in pediatrics is vast, so many providers have to select which items to focus on for their health screenings with these ages.”
Overall, “I was impressed with the improvements that were made in this quality improvement study,” said Ms. Thew.
Barriers to lipid screening in this population include the reduced number of health screenings and immunizations recommended for this age group; the consequence is that access is limited to discuss preventive care opportunities, said Ms. Thew in an interview. Steps to overcome these barriers could include the use of many of the screening tools introduced in the current study, such as point-of-care testing in the office, use of the EMR to remind providers of testing, which can be done during well visits or school physicals, and educating providers about the current guidelines, she noted.
Other strategies to increase screening include moving the immunization series to provide more frequent appointments to children aged 9-11 years to offer education and preventive care, Ms. Thew added.
The study received no outside funding. The researchers had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose and serves on the Editorial Advisory Board of Pediatric News.
WASHINGTON – A bundled intervention combining point-of-care testing, electronic medical record support, and provider education significantly improved lipid screening rates in children aged 9-11 years, according to data from approximately 100 monthly visits over a 3-year period.
Guidelines from the National Heart, Lung, and Blood Institute currently recommend universal lipid screening for children aged 9-11 years, but screening rates in clinical practice remain low, according to Ruth E. Gardner, MD, of Penn State University, Hershey, and colleagues.
In a poster presented at the Pediatric Academic Societies annual meeting, Dr. Gardner and colleagues shared results of the implementation of a bundled testing protocol designed to improve screening.
The researchers reviewed data on lipid testing within 30 days for all 9- to 11-year-old well child visits at a single center between May 2019 and February 2022. The bundled intervention was introduced in May 2021.
The bundled protocol included in-office capillary testing and provider education. In addition, electronic medical record templates were modified to include prompts for lipid screening at relevant ages, and EMR orders were adjusted to include lipid testing. The researchers also collected targeted provider feedback on individualized screening rates in February 2022.
Screening rates were plotted monthly. For the period from May 2019 through May 2021, the rates averaged 6.5%. However, after the introduction of the bundled intervention, the rate increased to 29.9%. Following targeted provider feedback in February 2022, the researchers found an additional shift to 52.1% through March and April 2022.
The findings were limited by the use of data from a single center, and the researchers used an extended study period to account for disruptions to well-child care in the spring of 2020 related to the COVID-19 pandemic.
However, the results support the effectiveness of a bundled intervention for improving lipid screening rates in children aged 9-11 years, the researchers said, and targeted provider feedback and education could yield additional improvements, they concluded.
Preteen years are an optimal time for screening
“The current study is important because atherosclerosis begins in childhood, and screening at ages 9-11 is an optimal time to begin lifestyle changes to improve overall health and reduce risks of heart disease,” said Margaret Thew, DNP, FNP-BC, of the Medical College of Wisconsin, Milwaukee, in an interview.
Ms. Thew, who was not involved in the study, said, “The number of recommended and required screening items needed in pediatrics is vast, so many providers have to select which items to focus on for their health screenings with these ages.”
Overall, “I was impressed with the improvements that were made in this quality improvement study,” said Ms. Thew.
Barriers to lipid screening in this population include the reduced number of health screenings and immunizations recommended for this age group; the consequence is that access is limited to discuss preventive care opportunities, said Ms. Thew in an interview. Steps to overcome these barriers could include the use of many of the screening tools introduced in the current study, such as point-of-care testing in the office, use of the EMR to remind providers of testing, which can be done during well visits or school physicals, and educating providers about the current guidelines, she noted.
Other strategies to increase screening include moving the immunization series to provide more frequent appointments to children aged 9-11 years to offer education and preventive care, Ms. Thew added.
The study received no outside funding. The researchers had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose and serves on the Editorial Advisory Board of Pediatric News.
WASHINGTON – A bundled intervention combining point-of-care testing, electronic medical record support, and provider education significantly improved lipid screening rates in children aged 9-11 years, according to data from approximately 100 monthly visits over a 3-year period.
Guidelines from the National Heart, Lung, and Blood Institute currently recommend universal lipid screening for children aged 9-11 years, but screening rates in clinical practice remain low, according to Ruth E. Gardner, MD, of Penn State University, Hershey, and colleagues.
In a poster presented at the Pediatric Academic Societies annual meeting, Dr. Gardner and colleagues shared results of the implementation of a bundled testing protocol designed to improve screening.
The researchers reviewed data on lipid testing within 30 days for all 9- to 11-year-old well child visits at a single center between May 2019 and February 2022. The bundled intervention was introduced in May 2021.
The bundled protocol included in-office capillary testing and provider education. In addition, electronic medical record templates were modified to include prompts for lipid screening at relevant ages, and EMR orders were adjusted to include lipid testing. The researchers also collected targeted provider feedback on individualized screening rates in February 2022.
Screening rates were plotted monthly. For the period from May 2019 through May 2021, the rates averaged 6.5%. However, after the introduction of the bundled intervention, the rate increased to 29.9%. Following targeted provider feedback in February 2022, the researchers found an additional shift to 52.1% through March and April 2022.
The findings were limited by the use of data from a single center, and the researchers used an extended study period to account for disruptions to well-child care in the spring of 2020 related to the COVID-19 pandemic.
However, the results support the effectiveness of a bundled intervention for improving lipid screening rates in children aged 9-11 years, the researchers said, and targeted provider feedback and education could yield additional improvements, they concluded.
Preteen years are an optimal time for screening
“The current study is important because atherosclerosis begins in childhood, and screening at ages 9-11 is an optimal time to begin lifestyle changes to improve overall health and reduce risks of heart disease,” said Margaret Thew, DNP, FNP-BC, of the Medical College of Wisconsin, Milwaukee, in an interview.
Ms. Thew, who was not involved in the study, said, “The number of recommended and required screening items needed in pediatrics is vast, so many providers have to select which items to focus on for their health screenings with these ages.”
Overall, “I was impressed with the improvements that were made in this quality improvement study,” said Ms. Thew.
Barriers to lipid screening in this population include the reduced number of health screenings and immunizations recommended for this age group; the consequence is that access is limited to discuss preventive care opportunities, said Ms. Thew in an interview. Steps to overcome these barriers could include the use of many of the screening tools introduced in the current study, such as point-of-care testing in the office, use of the EMR to remind providers of testing, which can be done during well visits or school physicals, and educating providers about the current guidelines, she noted.
Other strategies to increase screening include moving the immunization series to provide more frequent appointments to children aged 9-11 years to offer education and preventive care, Ms. Thew added.
The study received no outside funding. The researchers had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose and serves on the Editorial Advisory Board of Pediatric News.
FROM PAS 2023
New protocol could cut fasting period to detect insulinomas
SEATTLE – , therefore yielding significant hospital cost savings, new data suggest.
Insulinomas are small, rare types of pancreatic tumors that are benign but secrete excess insulin, leading to hypoglycemia. More than 99% of people with insulinomas develop hypoglycemia within 72 hours, hence, the use of a 72-hour fast to detect these tumors.
But most people who are evaluated for hypoglycemia do not have an insulinoma and fasting in hospital for 3 days is burdensome and costly.
As part of a quality improvement project, Cleveland Clinic endocrinology fellow Michelle D. Lundholm, MD, and colleagues modified their hospital’s protocol to include measurement of beta-hydroxybutyrate (BHB), a marker of insulin suppression, every 12 hours with a cutoff of ≥ 2.7mmol/L for stopping the fast if hypoglycemia (venous glucose ≤ 45mg/dL) hasn’t occurred. This intervention cut in half the number of patients who needed to fast for the full 72 hours, without missing any insulinomas.
“We are excited to share how a relatively simple adjustment to our protocol allowed us to successfully reduce the burden of fasting on patients and more effectively utilize hospital resources. We hope that this encourages other centers to consider doing the same,” Dr. Lundholm said in an interview.
“These data support a 48-hour fast. The literature supports that’s sufficient to detect 95% of insulinomas. ... But, given our small insulinoma cohort, we are looking forward to learning from other studies,” she added.
Dr. Lundholm presented the late-breaking oral abstract at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
Asked to comment, session moderator Jenna Sarvaideo, MD, said: “We’re often steeped in tradition. That’s why this abstract and this quality improvement project is so exciting to me because it challenges the history. … and I think it’s ultimately helping patients.”
Dr. Sarvaideo, of Clement J. Zablocki VA Medical Center, Milwaukee, noted that, typically, although the fast will be stopped before 72 hours if the patient develops hypoglycemia, “often they don’t, so we keep going on and on. If we just paid more attention to the beta-hydroxybutyrate, I think that would be practice changing.”
She added that more data would be optimal, given that there were under 100 patients in the study, “but I do think that devising protocols is … very much still at the hands of the endocrinologists. I think that this work could make groups reevaluate their protocol and change it, maybe even with a small dataset and then move on from there and see what they see.”
Indeed, Dr. Lundholm pointed out that some institutions, such as the Mayo Clinic, already include 6-hour BHB measurements (along with glucose and insulin) in their protocols.
“For any institution that already draws regular BHB levels like this, it would be very easy to implement a new stopping criterion without adding any additional costs,” she said in an interview.
All insulinomas became apparent in less than 48 hours
The first report to look at the value of testing BHB at regular intervals was published by the Mayo Clinic in 2005 after they noticed patients without insulinoma were complaining of ketosis symptoms such as foul breath and digestive problems toward the end of the fast.
However, although BHB testing is used today as part of the evaluation, it’s typically only drawn at the start of the protocol and again at the time of hypoglycemia or at the end of 72 hours because more frequent values hadn’t been thought to be useful for guiding clinical management, Dr. Lundholm explained.
Between January 2018 and June 2020, Dr. Lundholm and colleagues followed 34 Cleveland Clinic patients who completed the usual 72-hour fast protocol. Overall, 71% were female, and 26% had undergone prior bariatric surgery procedures. Eleven (32%) developed hypoglycemia and stopped fasting. The other 23 (68%) fasted for the full 72 hours.
Dr. Lundholm and colleagues determined that the fast could have ended earlier in 35% of patients based on an elevated BHB without missing any insulinomas.
And so, in June 2020 the group revised their protocol to include the BHB ≥ 2.7mmol/L stopping criterion. Of the 30 patients evaluated from June 2020 to January 2023, 87% were female and 17% had undergone a bariatric procedure.
Here, 15 (50%) reached a BHB ≥ 2.7mmol/L and ended their fast at an average of 43.8 hours. Another seven (23%) ended the fast after developing hypoglycemia. Just eight patients (27%) fasted for the full 72 hours.
Overall, this resulted in approximately 376 fewer cumulative hours of inpatient admission than if patients had fasted for the full time.
Of the 64 patients who have completed the fasting protocol since 2018, seven (11%) who did have an insulinoma developed hypoglycemia within 48 hours and with a BHB < 2.7 mmol/L (median, 0.15).
Advantages: cost, adherence
A day in a general medicine bed at Cleveland Clinic was quoted as costing $2,420, based on publicly available information as of Jan. 1, 2023. “If half of patients leave 1 day earlier, this equates to about $1,210 per patient in savings from bed costs alone,” Dr. Lundholm told this news organization.
The revised protocol required an additional two to four blood draws, depending on the length of the fast. “The cost of these extra blood tests varies by lab and by count, but even at its highest does not exceed the amount of savings from bed costs,” she noted.
Patient adherence is another potential benefit of the revised protocol.
“Any study that requires 72 hours of patient cooperation is a challenge, particularly in an uncomfortable position like fasting. When we looked at these adherence numbers, we found that the percentage of patients who prematurely ended their fast decreased from 35% to 17% with the updated protocol,” Dr. Lundholm continued.
“This translates to fewer inconclusive results and fewer readmissions for repeat 72-hour fasting. While this was not our primary outcome, it was another noted benefit of our change,” she said.
Dr. Lundholm and Dr. Sarvaideo have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
SEATTLE – , therefore yielding significant hospital cost savings, new data suggest.
Insulinomas are small, rare types of pancreatic tumors that are benign but secrete excess insulin, leading to hypoglycemia. More than 99% of people with insulinomas develop hypoglycemia within 72 hours, hence, the use of a 72-hour fast to detect these tumors.
But most people who are evaluated for hypoglycemia do not have an insulinoma and fasting in hospital for 3 days is burdensome and costly.
As part of a quality improvement project, Cleveland Clinic endocrinology fellow Michelle D. Lundholm, MD, and colleagues modified their hospital’s protocol to include measurement of beta-hydroxybutyrate (BHB), a marker of insulin suppression, every 12 hours with a cutoff of ≥ 2.7mmol/L for stopping the fast if hypoglycemia (venous glucose ≤ 45mg/dL) hasn’t occurred. This intervention cut in half the number of patients who needed to fast for the full 72 hours, without missing any insulinomas.
“We are excited to share how a relatively simple adjustment to our protocol allowed us to successfully reduce the burden of fasting on patients and more effectively utilize hospital resources. We hope that this encourages other centers to consider doing the same,” Dr. Lundholm said in an interview.
“These data support a 48-hour fast. The literature supports that’s sufficient to detect 95% of insulinomas. ... But, given our small insulinoma cohort, we are looking forward to learning from other studies,” she added.
Dr. Lundholm presented the late-breaking oral abstract at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
Asked to comment, session moderator Jenna Sarvaideo, MD, said: “We’re often steeped in tradition. That’s why this abstract and this quality improvement project is so exciting to me because it challenges the history. … and I think it’s ultimately helping patients.”
Dr. Sarvaideo, of Clement J. Zablocki VA Medical Center, Milwaukee, noted that, typically, although the fast will be stopped before 72 hours if the patient develops hypoglycemia, “often they don’t, so we keep going on and on. If we just paid more attention to the beta-hydroxybutyrate, I think that would be practice changing.”
She added that more data would be optimal, given that there were under 100 patients in the study, “but I do think that devising protocols is … very much still at the hands of the endocrinologists. I think that this work could make groups reevaluate their protocol and change it, maybe even with a small dataset and then move on from there and see what they see.”
Indeed, Dr. Lundholm pointed out that some institutions, such as the Mayo Clinic, already include 6-hour BHB measurements (along with glucose and insulin) in their protocols.
“For any institution that already draws regular BHB levels like this, it would be very easy to implement a new stopping criterion without adding any additional costs,” she said in an interview.
All insulinomas became apparent in less than 48 hours
The first report to look at the value of testing BHB at regular intervals was published by the Mayo Clinic in 2005 after they noticed patients without insulinoma were complaining of ketosis symptoms such as foul breath and digestive problems toward the end of the fast.
However, although BHB testing is used today as part of the evaluation, it’s typically only drawn at the start of the protocol and again at the time of hypoglycemia or at the end of 72 hours because more frequent values hadn’t been thought to be useful for guiding clinical management, Dr. Lundholm explained.
Between January 2018 and June 2020, Dr. Lundholm and colleagues followed 34 Cleveland Clinic patients who completed the usual 72-hour fast protocol. Overall, 71% were female, and 26% had undergone prior bariatric surgery procedures. Eleven (32%) developed hypoglycemia and stopped fasting. The other 23 (68%) fasted for the full 72 hours.
Dr. Lundholm and colleagues determined that the fast could have ended earlier in 35% of patients based on an elevated BHB without missing any insulinomas.
And so, in June 2020 the group revised their protocol to include the BHB ≥ 2.7mmol/L stopping criterion. Of the 30 patients evaluated from June 2020 to January 2023, 87% were female and 17% had undergone a bariatric procedure.
Here, 15 (50%) reached a BHB ≥ 2.7mmol/L and ended their fast at an average of 43.8 hours. Another seven (23%) ended the fast after developing hypoglycemia. Just eight patients (27%) fasted for the full 72 hours.
Overall, this resulted in approximately 376 fewer cumulative hours of inpatient admission than if patients had fasted for the full time.
Of the 64 patients who have completed the fasting protocol since 2018, seven (11%) who did have an insulinoma developed hypoglycemia within 48 hours and with a BHB < 2.7 mmol/L (median, 0.15).
Advantages: cost, adherence
A day in a general medicine bed at Cleveland Clinic was quoted as costing $2,420, based on publicly available information as of Jan. 1, 2023. “If half of patients leave 1 day earlier, this equates to about $1,210 per patient in savings from bed costs alone,” Dr. Lundholm told this news organization.
The revised protocol required an additional two to four blood draws, depending on the length of the fast. “The cost of these extra blood tests varies by lab and by count, but even at its highest does not exceed the amount of savings from bed costs,” she noted.
Patient adherence is another potential benefit of the revised protocol.
“Any study that requires 72 hours of patient cooperation is a challenge, particularly in an uncomfortable position like fasting. When we looked at these adherence numbers, we found that the percentage of patients who prematurely ended their fast decreased from 35% to 17% with the updated protocol,” Dr. Lundholm continued.
“This translates to fewer inconclusive results and fewer readmissions for repeat 72-hour fasting. While this was not our primary outcome, it was another noted benefit of our change,” she said.
Dr. Lundholm and Dr. Sarvaideo have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
SEATTLE – , therefore yielding significant hospital cost savings, new data suggest.
Insulinomas are small, rare types of pancreatic tumors that are benign but secrete excess insulin, leading to hypoglycemia. More than 99% of people with insulinomas develop hypoglycemia within 72 hours, hence, the use of a 72-hour fast to detect these tumors.
But most people who are evaluated for hypoglycemia do not have an insulinoma and fasting in hospital for 3 days is burdensome and costly.
As part of a quality improvement project, Cleveland Clinic endocrinology fellow Michelle D. Lundholm, MD, and colleagues modified their hospital’s protocol to include measurement of beta-hydroxybutyrate (BHB), a marker of insulin suppression, every 12 hours with a cutoff of ≥ 2.7mmol/L for stopping the fast if hypoglycemia (venous glucose ≤ 45mg/dL) hasn’t occurred. This intervention cut in half the number of patients who needed to fast for the full 72 hours, without missing any insulinomas.
“We are excited to share how a relatively simple adjustment to our protocol allowed us to successfully reduce the burden of fasting on patients and more effectively utilize hospital resources. We hope that this encourages other centers to consider doing the same,” Dr. Lundholm said in an interview.
“These data support a 48-hour fast. The literature supports that’s sufficient to detect 95% of insulinomas. ... But, given our small insulinoma cohort, we are looking forward to learning from other studies,” she added.
Dr. Lundholm presented the late-breaking oral abstract at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
Asked to comment, session moderator Jenna Sarvaideo, MD, said: “We’re often steeped in tradition. That’s why this abstract and this quality improvement project is so exciting to me because it challenges the history. … and I think it’s ultimately helping patients.”
Dr. Sarvaideo, of Clement J. Zablocki VA Medical Center, Milwaukee, noted that, typically, although the fast will be stopped before 72 hours if the patient develops hypoglycemia, “often they don’t, so we keep going on and on. If we just paid more attention to the beta-hydroxybutyrate, I think that would be practice changing.”
She added that more data would be optimal, given that there were under 100 patients in the study, “but I do think that devising protocols is … very much still at the hands of the endocrinologists. I think that this work could make groups reevaluate their protocol and change it, maybe even with a small dataset and then move on from there and see what they see.”
Indeed, Dr. Lundholm pointed out that some institutions, such as the Mayo Clinic, already include 6-hour BHB measurements (along with glucose and insulin) in their protocols.
“For any institution that already draws regular BHB levels like this, it would be very easy to implement a new stopping criterion without adding any additional costs,” she said in an interview.
All insulinomas became apparent in less than 48 hours
The first report to look at the value of testing BHB at regular intervals was published by the Mayo Clinic in 2005 after they noticed patients without insulinoma were complaining of ketosis symptoms such as foul breath and digestive problems toward the end of the fast.
However, although BHB testing is used today as part of the evaluation, it’s typically only drawn at the start of the protocol and again at the time of hypoglycemia or at the end of 72 hours because more frequent values hadn’t been thought to be useful for guiding clinical management, Dr. Lundholm explained.
Between January 2018 and June 2020, Dr. Lundholm and colleagues followed 34 Cleveland Clinic patients who completed the usual 72-hour fast protocol. Overall, 71% were female, and 26% had undergone prior bariatric surgery procedures. Eleven (32%) developed hypoglycemia and stopped fasting. The other 23 (68%) fasted for the full 72 hours.
Dr. Lundholm and colleagues determined that the fast could have ended earlier in 35% of patients based on an elevated BHB without missing any insulinomas.
And so, in June 2020 the group revised their protocol to include the BHB ≥ 2.7mmol/L stopping criterion. Of the 30 patients evaluated from June 2020 to January 2023, 87% were female and 17% had undergone a bariatric procedure.
Here, 15 (50%) reached a BHB ≥ 2.7mmol/L and ended their fast at an average of 43.8 hours. Another seven (23%) ended the fast after developing hypoglycemia. Just eight patients (27%) fasted for the full 72 hours.
Overall, this resulted in approximately 376 fewer cumulative hours of inpatient admission than if patients had fasted for the full time.
Of the 64 patients who have completed the fasting protocol since 2018, seven (11%) who did have an insulinoma developed hypoglycemia within 48 hours and with a BHB < 2.7 mmol/L (median, 0.15).
Advantages: cost, adherence
A day in a general medicine bed at Cleveland Clinic was quoted as costing $2,420, based on publicly available information as of Jan. 1, 2023. “If half of patients leave 1 day earlier, this equates to about $1,210 per patient in savings from bed costs alone,” Dr. Lundholm told this news organization.
The revised protocol required an additional two to four blood draws, depending on the length of the fast. “The cost of these extra blood tests varies by lab and by count, but even at its highest does not exceed the amount of savings from bed costs,” she noted.
Patient adherence is another potential benefit of the revised protocol.
“Any study that requires 72 hours of patient cooperation is a challenge, particularly in an uncomfortable position like fasting. When we looked at these adherence numbers, we found that the percentage of patients who prematurely ended their fast decreased from 35% to 17% with the updated protocol,” Dr. Lundholm continued.
“This translates to fewer inconclusive results and fewer readmissions for repeat 72-hour fasting. While this was not our primary outcome, it was another noted benefit of our change,” she said.
Dr. Lundholm and Dr. Sarvaideo have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
AT AACE 2023
Low disease state for childhood lupus approaches validation
MANCHESTER, ENGLAND – An age-appropriate version of the Lupus Low Disease Activity State (LLDAS) has been developed by an international task force that will hopefully enable childhood-onset systemic lupus erythematosus (cSLE) to be treated to target in the near future.
The new childhood LLDAS (cLLDAS) has been purposefully developed to align with that already used for adults, Eve Smith, MBChB, PhD, explained at the annual meeting of the British Society for Rheumatology.
“There’s a lot of compelling data that’s accumulating from adult lupus and increasingly from childhood lupus that [treat to target] might be a good idea,” said Dr. Smith, who is a senior clinical fellow and honorary consultant at the University of Liverpool (England) and Alder Hey Children’s NHS Foundation Trust Hospital, also in Liverpool.
Urgent need to improve childhood lupus outcomes
“We urgently need to do something to try and improve outcomes for children,” Dr. Smith said.
“We know that childhood lupus patients have got higher disease activity as compared to adults; they have a greater medication burden, particularly steroids; and they tend to have more severe organ manifestations,” she added.
Moreover, data show that one-fifth of pediatric patients with lupus have already accrued early damage, and there is much higher mortality associated with childhood lupus than there is with adult lupus.
“So, really we want to use treat to target as a way to try and improve on these aspects,” Dr. Smith said.
The treat-to-target (T2T) approach is not a new idea in lupus, with a lot of work already done in adult patients. One large study of more than 3,300 patients conducted in 13 countries has shown that patients who never achieve LLDAS are more likely to have high levels of damage, greater glucocorticoid use, worse quality of life, and higher mortality than are those who do.
Conversely, data have also shown that achieving a LLDAS is associated with a reduction in the risk for new damage, flares, and hospitalization, as well as reducing health care costs and improving patients’ overall health-related quality of life.
T2T is a recognized approach in European adult SLE guidelines, Dr. Smith said, although the approach has not really been fully realized as of yet, even in adult practice.
The cSLE T2T international task force and cLLDAS definition
With evidence accumulating on the benefits of getting children with SLE to a low disease activity state, Dr. Smith and colleague Michael Beresford, MBChB, PhD, Brough Chair, Professor of Child Health at the University of Liverpool, put out a call to develop a task force to look into the feasibility of a T2T approach.
“We had a really enthusiastic response internationally, which we were really encouraged by,” Dr. Smith said, “and we now lead a task force of 20 experts from across all five continents, and we have really strong patient involvement.”
Through a consensus process, an international cSLE T2T Task Force agreed on overarching principles and points to consider that will “lay the foundation for future T2T approaches in cSLE,” according to the recommendations statement, which was endorsed by the Paediatric Rheumatology European Society.
Next, they looked to develop an age-appropriate definition for low disease activity.
“We’re deliberately wanting to maintain sufficient unity with the adult definition, so that we could facilitate life-course studies,” said Dr. Smith, who presented the results of a literature review and series of Delphi surveys at the meeting.
The conceptual definition of cLLDAS is similar to adults in describing it as a sustained state that is associated with a low likelihood of adverse outcome, Dr. Smith said, but with the added wording of “considering disease activity, damage, and medication toxicity.”
The definition is achieved when the SLE Disease Activity Index-2K is ≤ 4 and there is no activity in major organ systems; there are no new features of lupus disease activity since the last assessment; there is a score of ≤ 1 on Physician Global Assessment; steroid doses are ≤ 0.15 mg/kg/day or a maximum of 7.5 mg/day (whichever is lower); and immunosuppressive treatment is stable, with any changes to medication only because of side effects, adherence, changes in weight, or when in the process of reaching a target dose.
“It’s all very well having a definition, but you need to think about how that will work in practice,” Dr. Smith said. This is something that the task force is thinking about very carefully.
The task force next aims to validate the cLLDAS definition, form an extensive research agenda to inform the T2T methods, and develop innovative methods to apply the approach in practice.
The work is supported by the Wellcome Trust, National Institutes for Health Research, Versus Arthritis, and the University of Liverpool, Alder Hey Children’s NHS Foundation Trust and the Alder Hey Charity. Dr. Smith reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
MANCHESTER, ENGLAND – An age-appropriate version of the Lupus Low Disease Activity State (LLDAS) has been developed by an international task force that will hopefully enable childhood-onset systemic lupus erythematosus (cSLE) to be treated to target in the near future.
The new childhood LLDAS (cLLDAS) has been purposefully developed to align with that already used for adults, Eve Smith, MBChB, PhD, explained at the annual meeting of the British Society for Rheumatology.
“There’s a lot of compelling data that’s accumulating from adult lupus and increasingly from childhood lupus that [treat to target] might be a good idea,” said Dr. Smith, who is a senior clinical fellow and honorary consultant at the University of Liverpool (England) and Alder Hey Children’s NHS Foundation Trust Hospital, also in Liverpool.
Urgent need to improve childhood lupus outcomes
“We urgently need to do something to try and improve outcomes for children,” Dr. Smith said.
“We know that childhood lupus patients have got higher disease activity as compared to adults; they have a greater medication burden, particularly steroids; and they tend to have more severe organ manifestations,” she added.
Moreover, data show that one-fifth of pediatric patients with lupus have already accrued early damage, and there is much higher mortality associated with childhood lupus than there is with adult lupus.
“So, really we want to use treat to target as a way to try and improve on these aspects,” Dr. Smith said.
The treat-to-target (T2T) approach is not a new idea in lupus, with a lot of work already done in adult patients. One large study of more than 3,300 patients conducted in 13 countries has shown that patients who never achieve LLDAS are more likely to have high levels of damage, greater glucocorticoid use, worse quality of life, and higher mortality than are those who do.
Conversely, data have also shown that achieving a LLDAS is associated with a reduction in the risk for new damage, flares, and hospitalization, as well as reducing health care costs and improving patients’ overall health-related quality of life.
T2T is a recognized approach in European adult SLE guidelines, Dr. Smith said, although the approach has not really been fully realized as of yet, even in adult practice.
The cSLE T2T international task force and cLLDAS definition
With evidence accumulating on the benefits of getting children with SLE to a low disease activity state, Dr. Smith and colleague Michael Beresford, MBChB, PhD, Brough Chair, Professor of Child Health at the University of Liverpool, put out a call to develop a task force to look into the feasibility of a T2T approach.
“We had a really enthusiastic response internationally, which we were really encouraged by,” Dr. Smith said, “and we now lead a task force of 20 experts from across all five continents, and we have really strong patient involvement.”
Through a consensus process, an international cSLE T2T Task Force agreed on overarching principles and points to consider that will “lay the foundation for future T2T approaches in cSLE,” according to the recommendations statement, which was endorsed by the Paediatric Rheumatology European Society.
Next, they looked to develop an age-appropriate definition for low disease activity.
“We’re deliberately wanting to maintain sufficient unity with the adult definition, so that we could facilitate life-course studies,” said Dr. Smith, who presented the results of a literature review and series of Delphi surveys at the meeting.
The conceptual definition of cLLDAS is similar to adults in describing it as a sustained state that is associated with a low likelihood of adverse outcome, Dr. Smith said, but with the added wording of “considering disease activity, damage, and medication toxicity.”
The definition is achieved when the SLE Disease Activity Index-2K is ≤ 4 and there is no activity in major organ systems; there are no new features of lupus disease activity since the last assessment; there is a score of ≤ 1 on Physician Global Assessment; steroid doses are ≤ 0.15 mg/kg/day or a maximum of 7.5 mg/day (whichever is lower); and immunosuppressive treatment is stable, with any changes to medication only because of side effects, adherence, changes in weight, or when in the process of reaching a target dose.
“It’s all very well having a definition, but you need to think about how that will work in practice,” Dr. Smith said. This is something that the task force is thinking about very carefully.
The task force next aims to validate the cLLDAS definition, form an extensive research agenda to inform the T2T methods, and develop innovative methods to apply the approach in practice.
The work is supported by the Wellcome Trust, National Institutes for Health Research, Versus Arthritis, and the University of Liverpool, Alder Hey Children’s NHS Foundation Trust and the Alder Hey Charity. Dr. Smith reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
MANCHESTER, ENGLAND – An age-appropriate version of the Lupus Low Disease Activity State (LLDAS) has been developed by an international task force that will hopefully enable childhood-onset systemic lupus erythematosus (cSLE) to be treated to target in the near future.
The new childhood LLDAS (cLLDAS) has been purposefully developed to align with that already used for adults, Eve Smith, MBChB, PhD, explained at the annual meeting of the British Society for Rheumatology.
“There’s a lot of compelling data that’s accumulating from adult lupus and increasingly from childhood lupus that [treat to target] might be a good idea,” said Dr. Smith, who is a senior clinical fellow and honorary consultant at the University of Liverpool (England) and Alder Hey Children’s NHS Foundation Trust Hospital, also in Liverpool.
Urgent need to improve childhood lupus outcomes
“We urgently need to do something to try and improve outcomes for children,” Dr. Smith said.
“We know that childhood lupus patients have got higher disease activity as compared to adults; they have a greater medication burden, particularly steroids; and they tend to have more severe organ manifestations,” she added.
Moreover, data show that one-fifth of pediatric patients with lupus have already accrued early damage, and there is much higher mortality associated with childhood lupus than there is with adult lupus.
“So, really we want to use treat to target as a way to try and improve on these aspects,” Dr. Smith said.
The treat-to-target (T2T) approach is not a new idea in lupus, with a lot of work already done in adult patients. One large study of more than 3,300 patients conducted in 13 countries has shown that patients who never achieve LLDAS are more likely to have high levels of damage, greater glucocorticoid use, worse quality of life, and higher mortality than are those who do.
Conversely, data have also shown that achieving a LLDAS is associated with a reduction in the risk for new damage, flares, and hospitalization, as well as reducing health care costs and improving patients’ overall health-related quality of life.
T2T is a recognized approach in European adult SLE guidelines, Dr. Smith said, although the approach has not really been fully realized as of yet, even in adult practice.
The cSLE T2T international task force and cLLDAS definition
With evidence accumulating on the benefits of getting children with SLE to a low disease activity state, Dr. Smith and colleague Michael Beresford, MBChB, PhD, Brough Chair, Professor of Child Health at the University of Liverpool, put out a call to develop a task force to look into the feasibility of a T2T approach.
“We had a really enthusiastic response internationally, which we were really encouraged by,” Dr. Smith said, “and we now lead a task force of 20 experts from across all five continents, and we have really strong patient involvement.”
Through a consensus process, an international cSLE T2T Task Force agreed on overarching principles and points to consider that will “lay the foundation for future T2T approaches in cSLE,” according to the recommendations statement, which was endorsed by the Paediatric Rheumatology European Society.
Next, they looked to develop an age-appropriate definition for low disease activity.
“We’re deliberately wanting to maintain sufficient unity with the adult definition, so that we could facilitate life-course studies,” said Dr. Smith, who presented the results of a literature review and series of Delphi surveys at the meeting.
The conceptual definition of cLLDAS is similar to adults in describing it as a sustained state that is associated with a low likelihood of adverse outcome, Dr. Smith said, but with the added wording of “considering disease activity, damage, and medication toxicity.”
The definition is achieved when the SLE Disease Activity Index-2K is ≤ 4 and there is no activity in major organ systems; there are no new features of lupus disease activity since the last assessment; there is a score of ≤ 1 on Physician Global Assessment; steroid doses are ≤ 0.15 mg/kg/day or a maximum of 7.5 mg/day (whichever is lower); and immunosuppressive treatment is stable, with any changes to medication only because of side effects, adherence, changes in weight, or when in the process of reaching a target dose.
“It’s all very well having a definition, but you need to think about how that will work in practice,” Dr. Smith said. This is something that the task force is thinking about very carefully.
The task force next aims to validate the cLLDAS definition, form an extensive research agenda to inform the T2T methods, and develop innovative methods to apply the approach in practice.
The work is supported by the Wellcome Trust, National Institutes for Health Research, Versus Arthritis, and the University of Liverpool, Alder Hey Children’s NHS Foundation Trust and the Alder Hey Charity. Dr. Smith reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT BSR 2023
Mohs surgery improves survival in early-stage Merkel cell carcinoma
SEATTLE – The use of
Compared with conventional wide local excision, survival was significantly improved among patients treated with Mohs, and a subgroup analysis showed that the survival benefit remained for patients with risk factors.
“At 10 years, overall survival was about 21% higher for those treated with Mohs surgery versus those treated with conventional surgery,” said lead author Shayan Cheraghlou, MD, a dermatology resident at the New York University School of Medicine. “On multivariable analysis, which controlled for tumor and patient factors, Mohs was associated with an over 40% reduction in the hazard for death.”
The findings were presented at the annual meeting of the American College of Mohs Surgery.
MCC is a rare, aggressive, neuroendocrine cutaneous malignancy that carries a high mortality rate. The estimated 5-year survival for patients with localized disease is about 50%, Dr. Cheraghlou noted. “That extrapolates to about 55% for T1 tumors and down to about 30% for T4 tumors.”
Although it’s considered to be a rare cancer, the incidence of MCC has been rapidly rising, and in fact it doubled during the period from the 1990s to the 2010s.
Most commonly treated with wide local excision with or without adjuvant radiation therapy, Mohs as monotherapy may offer an alternative treatment option for patients with MCC. It is generally accepted that the optimal treatment for tumors without regional lymph node involvement is surgical, but the data regarding the optimal surgical approach are mixed. Current National Comprehensive Cancer Network guidelines state that either Mohs surgery or wide local excision can be used.
“However, these guidelines do not indicate a preference for one modality over the other,” said Dr. Cheraghlou, “and present them as interchangeable treatment options.”
A growing body of literature supports Mohs surgery for many types of rare tumors, including MCC. For example, as previously reported at the 2021 ACMS meeting, one study found that Mohs surgery compared favorably with the standard treatment approach when it came to recurrence rates for patients with MCC. The 5-year disease-specific survival rate was 91.2% for patients with stage I disease and 68.6% for patients with stage IIa. These rates were comparable with rates for historical control patients who were treated with wide local excision, with or without radiation (81%-87% for stage I disease, and 63%-67% for stage II).
Study details
In the current study, Dr. Cheraghlou and colleagues sought to evaluate the association of the type of surgical approach with patient survival after excision of early-stage MCC. They conducted a retrospective cohort study using the National Cancer Database to identify cases of MCC with T1/T2 tumors. A total of 2,313 patients who were diagnosed from 2004 to 2018 with pathologically confirmed negative lymph node involvement and who were treated with Mohs surgery or wide lesion excision were included in the analysis.
“About 90% were T1 tumors, about 40% were located on the head and neck, and the vast majority – about 60% – were treated with wide local excision,” he explained. “Only about 5% received Mohs surgery for treatment of the primary tumor.”
But when the researchers assessed survival outcomes, they found that treatment with Mohs surgery was associated with significantly improved overall survival.
The unadjusted 3-, 5-, and 10-year survival rates for patients treated with Mohs was 87.4% (SE: 3.4%), 84.5% (SE: 3.9%), and 81.8% (SE: 4.6%), respectively, while for wide lesion excision, the rates were 86.1% (SE: 0.9%), 76.9% (SE: 1.2%), and 60.9% (SE: 2.0%), respectively.
For patients who underwent treatment with narrow margin excision, survival rates were similar as for those treated with wide lesion excision, with 3-, 5-, and 10-year survival rates of 84.8% (SE: 1.4%), 78.3% (SE: 1.7%), and 60.8% (SE: 3.6%), respectively.
On multivariable survival analysis, Mohs surgery was associated with significantly improved survival, compared with wide lesion excision (hazard ratio, 0.594; P = .038). This was also true after multivariable analysis for patients who had one or more NCCN risk factors, for whom improved survival was also seen with Mohs (HR, 0.530; P = .026).
The results did not differ after a sensitivity analysis that included T3 and T4 tumors.
Given that the use of Mohs was so infrequent, compared with standard surgery, the researchers investigated the factors that were associated with the use of Mohs. High-volume MCC centers were significantly more likely to utilize Mohs than wide lesion excision (odds ratio, 1.993; P < .001), compared with other facilities.
“This study has important implications going forward,” Dr. Cheraghlou concluded. “We think it’s important how few patients were treated with Mohs for Merkel cell, and it was slightly more likely to happen in a high-volume center.”
The reasoning for that may be that high-volume centers are more likely to have a surgeon trained to perform Mohs surgery for MCC. “Or perhaps they are more attuned to the benefits of this procedure,” he said. “We can’t tell that from our data, but its notable that it’s such a small proportion of patients – especially when we consider that it is associated with improved survival for the patients who receive it.”
He added that efforts to increase the utilization of Mohs may yield improved local control and overall survival for these patients. “And perhaps with more data, future versions of guidelines may indicate a preference for Mohs over conventional incisions.”
No changes to current practice
Asked to comment on the study, Anthony J. Olszanski, RPh, MD, associate professor, department of hematology/oncology, Fox Chase Cancer Center, Philadelphia, noted that while the results are intriguing, they must be interpreted with caution.
“This study was retrospective in nature, and unrecognized biases can influence results,” he said. “Additionally, given the relative rarity of Merkel cell carcinoma, the sample size is expectantly small.”
But importantly, Dr. Olszanski emphasized, Mohs may more often have been recommended for patients with lesions that appear less aggressive. “Many patients undergoing wide lesion excision may have been referred by Mohs surgeons secondary to features or characteristics of lesions which were worrisome,” he explained. “The results of this study do not opine on why Mohs would impact overall survival over wide lesion excision, a point worthy of consideration. Presently, both modalities can be considered for patients with T1/T2 MCC. The results of this study should not change current practice and would lend themselves to a more robust study.”
No external funding of the study was reported. Dr. Cheraghlou has disclosed no relevant financial relationships. Dr. Olszanski has received financial support from Merck and BMS for participated on advisory boards.
A version of this article originally appeared on Medscape.com.
SEATTLE – The use of
Compared with conventional wide local excision, survival was significantly improved among patients treated with Mohs, and a subgroup analysis showed that the survival benefit remained for patients with risk factors.
“At 10 years, overall survival was about 21% higher for those treated with Mohs surgery versus those treated with conventional surgery,” said lead author Shayan Cheraghlou, MD, a dermatology resident at the New York University School of Medicine. “On multivariable analysis, which controlled for tumor and patient factors, Mohs was associated with an over 40% reduction in the hazard for death.”
The findings were presented at the annual meeting of the American College of Mohs Surgery.
MCC is a rare, aggressive, neuroendocrine cutaneous malignancy that carries a high mortality rate. The estimated 5-year survival for patients with localized disease is about 50%, Dr. Cheraghlou noted. “That extrapolates to about 55% for T1 tumors and down to about 30% for T4 tumors.”
Although it’s considered to be a rare cancer, the incidence of MCC has been rapidly rising, and in fact it doubled during the period from the 1990s to the 2010s.
Most commonly treated with wide local excision with or without adjuvant radiation therapy, Mohs as monotherapy may offer an alternative treatment option for patients with MCC. It is generally accepted that the optimal treatment for tumors without regional lymph node involvement is surgical, but the data regarding the optimal surgical approach are mixed. Current National Comprehensive Cancer Network guidelines state that either Mohs surgery or wide local excision can be used.
“However, these guidelines do not indicate a preference for one modality over the other,” said Dr. Cheraghlou, “and present them as interchangeable treatment options.”
A growing body of literature supports Mohs surgery for many types of rare tumors, including MCC. For example, as previously reported at the 2021 ACMS meeting, one study found that Mohs surgery compared favorably with the standard treatment approach when it came to recurrence rates for patients with MCC. The 5-year disease-specific survival rate was 91.2% for patients with stage I disease and 68.6% for patients with stage IIa. These rates were comparable with rates for historical control patients who were treated with wide local excision, with or without radiation (81%-87% for stage I disease, and 63%-67% for stage II).
Study details
In the current study, Dr. Cheraghlou and colleagues sought to evaluate the association of the type of surgical approach with patient survival after excision of early-stage MCC. They conducted a retrospective cohort study using the National Cancer Database to identify cases of MCC with T1/T2 tumors. A total of 2,313 patients who were diagnosed from 2004 to 2018 with pathologically confirmed negative lymph node involvement and who were treated with Mohs surgery or wide lesion excision were included in the analysis.
“About 90% were T1 tumors, about 40% were located on the head and neck, and the vast majority – about 60% – were treated with wide local excision,” he explained. “Only about 5% received Mohs surgery for treatment of the primary tumor.”
But when the researchers assessed survival outcomes, they found that treatment with Mohs surgery was associated with significantly improved overall survival.
The unadjusted 3-, 5-, and 10-year survival rates for patients treated with Mohs was 87.4% (SE: 3.4%), 84.5% (SE: 3.9%), and 81.8% (SE: 4.6%), respectively, while for wide lesion excision, the rates were 86.1% (SE: 0.9%), 76.9% (SE: 1.2%), and 60.9% (SE: 2.0%), respectively.
For patients who underwent treatment with narrow margin excision, survival rates were similar as for those treated with wide lesion excision, with 3-, 5-, and 10-year survival rates of 84.8% (SE: 1.4%), 78.3% (SE: 1.7%), and 60.8% (SE: 3.6%), respectively.
On multivariable survival analysis, Mohs surgery was associated with significantly improved survival, compared with wide lesion excision (hazard ratio, 0.594; P = .038). This was also true after multivariable analysis for patients who had one or more NCCN risk factors, for whom improved survival was also seen with Mohs (HR, 0.530; P = .026).
The results did not differ after a sensitivity analysis that included T3 and T4 tumors.
Given that the use of Mohs was so infrequent, compared with standard surgery, the researchers investigated the factors that were associated with the use of Mohs. High-volume MCC centers were significantly more likely to utilize Mohs than wide lesion excision (odds ratio, 1.993; P < .001), compared with other facilities.
“This study has important implications going forward,” Dr. Cheraghlou concluded. “We think it’s important how few patients were treated with Mohs for Merkel cell, and it was slightly more likely to happen in a high-volume center.”
The reasoning for that may be that high-volume centers are more likely to have a surgeon trained to perform Mohs surgery for MCC. “Or perhaps they are more attuned to the benefits of this procedure,” he said. “We can’t tell that from our data, but its notable that it’s such a small proportion of patients – especially when we consider that it is associated with improved survival for the patients who receive it.”
He added that efforts to increase the utilization of Mohs may yield improved local control and overall survival for these patients. “And perhaps with more data, future versions of guidelines may indicate a preference for Mohs over conventional incisions.”
No changes to current practice
Asked to comment on the study, Anthony J. Olszanski, RPh, MD, associate professor, department of hematology/oncology, Fox Chase Cancer Center, Philadelphia, noted that while the results are intriguing, they must be interpreted with caution.
“This study was retrospective in nature, and unrecognized biases can influence results,” he said. “Additionally, given the relative rarity of Merkel cell carcinoma, the sample size is expectantly small.”
But importantly, Dr. Olszanski emphasized, Mohs may more often have been recommended for patients with lesions that appear less aggressive. “Many patients undergoing wide lesion excision may have been referred by Mohs surgeons secondary to features or characteristics of lesions which were worrisome,” he explained. “The results of this study do not opine on why Mohs would impact overall survival over wide lesion excision, a point worthy of consideration. Presently, both modalities can be considered for patients with T1/T2 MCC. The results of this study should not change current practice and would lend themselves to a more robust study.”
No external funding of the study was reported. Dr. Cheraghlou has disclosed no relevant financial relationships. Dr. Olszanski has received financial support from Merck and BMS for participated on advisory boards.
A version of this article originally appeared on Medscape.com.
SEATTLE – The use of
Compared with conventional wide local excision, survival was significantly improved among patients treated with Mohs, and a subgroup analysis showed that the survival benefit remained for patients with risk factors.
“At 10 years, overall survival was about 21% higher for those treated with Mohs surgery versus those treated with conventional surgery,” said lead author Shayan Cheraghlou, MD, a dermatology resident at the New York University School of Medicine. “On multivariable analysis, which controlled for tumor and patient factors, Mohs was associated with an over 40% reduction in the hazard for death.”
The findings were presented at the annual meeting of the American College of Mohs Surgery.
MCC is a rare, aggressive, neuroendocrine cutaneous malignancy that carries a high mortality rate. The estimated 5-year survival for patients with localized disease is about 50%, Dr. Cheraghlou noted. “That extrapolates to about 55% for T1 tumors and down to about 30% for T4 tumors.”
Although it’s considered to be a rare cancer, the incidence of MCC has been rapidly rising, and in fact it doubled during the period from the 1990s to the 2010s.
Most commonly treated with wide local excision with or without adjuvant radiation therapy, Mohs as monotherapy may offer an alternative treatment option for patients with MCC. It is generally accepted that the optimal treatment for tumors without regional lymph node involvement is surgical, but the data regarding the optimal surgical approach are mixed. Current National Comprehensive Cancer Network guidelines state that either Mohs surgery or wide local excision can be used.
“However, these guidelines do not indicate a preference for one modality over the other,” said Dr. Cheraghlou, “and present them as interchangeable treatment options.”
A growing body of literature supports Mohs surgery for many types of rare tumors, including MCC. For example, as previously reported at the 2021 ACMS meeting, one study found that Mohs surgery compared favorably with the standard treatment approach when it came to recurrence rates for patients with MCC. The 5-year disease-specific survival rate was 91.2% for patients with stage I disease and 68.6% for patients with stage IIa. These rates were comparable with rates for historical control patients who were treated with wide local excision, with or without radiation (81%-87% for stage I disease, and 63%-67% for stage II).
Study details
In the current study, Dr. Cheraghlou and colleagues sought to evaluate the association of the type of surgical approach with patient survival after excision of early-stage MCC. They conducted a retrospective cohort study using the National Cancer Database to identify cases of MCC with T1/T2 tumors. A total of 2,313 patients who were diagnosed from 2004 to 2018 with pathologically confirmed negative lymph node involvement and who were treated with Mohs surgery or wide lesion excision were included in the analysis.
“About 90% were T1 tumors, about 40% were located on the head and neck, and the vast majority – about 60% – were treated with wide local excision,” he explained. “Only about 5% received Mohs surgery for treatment of the primary tumor.”
But when the researchers assessed survival outcomes, they found that treatment with Mohs surgery was associated with significantly improved overall survival.
The unadjusted 3-, 5-, and 10-year survival rates for patients treated with Mohs was 87.4% (SE: 3.4%), 84.5% (SE: 3.9%), and 81.8% (SE: 4.6%), respectively, while for wide lesion excision, the rates were 86.1% (SE: 0.9%), 76.9% (SE: 1.2%), and 60.9% (SE: 2.0%), respectively.
For patients who underwent treatment with narrow margin excision, survival rates were similar as for those treated with wide lesion excision, with 3-, 5-, and 10-year survival rates of 84.8% (SE: 1.4%), 78.3% (SE: 1.7%), and 60.8% (SE: 3.6%), respectively.
On multivariable survival analysis, Mohs surgery was associated with significantly improved survival, compared with wide lesion excision (hazard ratio, 0.594; P = .038). This was also true after multivariable analysis for patients who had one or more NCCN risk factors, for whom improved survival was also seen with Mohs (HR, 0.530; P = .026).
The results did not differ after a sensitivity analysis that included T3 and T4 tumors.
Given that the use of Mohs was so infrequent, compared with standard surgery, the researchers investigated the factors that were associated with the use of Mohs. High-volume MCC centers were significantly more likely to utilize Mohs than wide lesion excision (odds ratio, 1.993; P < .001), compared with other facilities.
“This study has important implications going forward,” Dr. Cheraghlou concluded. “We think it’s important how few patients were treated with Mohs for Merkel cell, and it was slightly more likely to happen in a high-volume center.”
The reasoning for that may be that high-volume centers are more likely to have a surgeon trained to perform Mohs surgery for MCC. “Or perhaps they are more attuned to the benefits of this procedure,” he said. “We can’t tell that from our data, but its notable that it’s such a small proportion of patients – especially when we consider that it is associated with improved survival for the patients who receive it.”
He added that efforts to increase the utilization of Mohs may yield improved local control and overall survival for these patients. “And perhaps with more data, future versions of guidelines may indicate a preference for Mohs over conventional incisions.”
No changes to current practice
Asked to comment on the study, Anthony J. Olszanski, RPh, MD, associate professor, department of hematology/oncology, Fox Chase Cancer Center, Philadelphia, noted that while the results are intriguing, they must be interpreted with caution.
“This study was retrospective in nature, and unrecognized biases can influence results,” he said. “Additionally, given the relative rarity of Merkel cell carcinoma, the sample size is expectantly small.”
But importantly, Dr. Olszanski emphasized, Mohs may more often have been recommended for patients with lesions that appear less aggressive. “Many patients undergoing wide lesion excision may have been referred by Mohs surgeons secondary to features or characteristics of lesions which were worrisome,” he explained. “The results of this study do not opine on why Mohs would impact overall survival over wide lesion excision, a point worthy of consideration. Presently, both modalities can be considered for patients with T1/T2 MCC. The results of this study should not change current practice and would lend themselves to a more robust study.”
No external funding of the study was reported. Dr. Cheraghlou has disclosed no relevant financial relationships. Dr. Olszanski has received financial support from Merck and BMS for participated on advisory boards.
A version of this article originally appeared on Medscape.com.
AT ACMS 2023
Surprisingly more nonsustained VT shown in HCM using extended ECG monitoring
BARCELONA – , suggests a study that questions current risk stratification practices in HCM.
In the registry study, such arrythmias were observed in about six times as many HCM patients during 30 days of ambulatory electrocardiographic monitoring as would have been identified based on the first 24 hours of the monitoring period: 65% vs. 11% of the cohort.
Also, about 62% of the patients showed NSVT at “extended” 30-day monitoring, compared with an 8% prevalence of the arrhythmia based on the more conventional ECG monitoring period of 24 hours.
Nonsustained ventricular tachycardia, an important arrhythmia used every day in clinical practice to make decisions, is “much, much more prevalent than we thought” in patients with HCM, Juan Caro Codón, MD, the study’s principal investigator, said in an interview. “We should invest in further research regarding extended ECG monitoring in these patients.”
Dr. Caro Codón, of La Paz University Hospital, Madrid, presented the findings from the TEMPO-HCM study at the European Heart Rhythm Association 2023 Congress, held in Barcelona and virtually.
Its results, he said, have implications for stratifying HCM patients according to their risk for sudden cardiac death in deciding who should be offered an implantable cardioverter-defibrillator (ICD).
The life-incidence of atrial fibrillation (AF) in patients like those in the current analysis has previously been found to be about 20%, and the life-prevalence of NSVT about 20%-30%, using traditional 24- or 48-hour Holter monitoring, Dr. Caro Codón said.
“These arrhythmias are clinically relevant events because they are linked to very meaningful clinical endpoints,” including stroke and thromboembolism, he said, “but also for sudden cardiac death.”
Extended ECG monitoring has been shown useful in the setting of cryptogenic stroke and after AF ablation, but similar findings have been scarce in HCM. Patients using personal wearable monitors such as smart watches, Dr. Caro Codón said, have come to his clinic with concerns that the devices may have signaled a problem. But the lack of relevant data leaves them without a sufficient answer.
In other findings, invited discussant Isabelle van Gelder, MD, PhD, observed after Dr. Caro Codón’s presentation that the number of patients with AF almost doubled based on extended monitoring, compared with the first 24 hours of monitoring.
Based on European Society of Cardiology guidelines from 2020, “Once clinical AF has been documented, there is a class IIA recommendation to start anticoagulation,” said Dr. van Gelder, University of Groningen, the Netherlands. “Therefore, your data really are a call for more data on screening for AF in hypertrophic cardiomyopathy patients.”
Prospective multicenter registry
The TEMPO-HCM registry includes patients with HCM and a clinical indication for standard Holter monitoring at five hospitals in Spain. It excludes patients with an HCM-like phenotype but who lack the telltale genotype, as well as those already implanted with an ICD.
Those in the current analysis underwent 30-day ECG monitoring with a small, wearable device that Dr. Caro Codón described as about 7 cm long, worn in what is essentially a T-shirt with a pocket. Patients could remove the shirt and device to bathe or go swimming, for example, and still be monitored for most of the day.
The analysis included the registry’s first 100 patients (mean age, 57 years; 78% male). Hypertension was present in 47%, 58% were on beta-blockers, 16% had prior AF or atrial flutter, and 19% were taking anticoagulants. Only 8% were on antiarrhythmic drugs, Dr. Caro Codón reported.
The patients had good functional status (68% and 29% were in NYHA class 1 and 2, respectively) and their left ventricular ejection fraction averaged 66%. Of the 71 patients who underwent MRI, 28.2% showed late gadolinium enhancement suggesting myocardial scarring.
More arrhythmias on 30-day monitoring
The primary endpoint of clinically relevant arrhythmia (AF, atrial flutter, or NSVT) was identified during the first 24 hours of monitoring in 11% of patients. The prevalence rose to 65% (P < .001) based on 30-day monitoring.
Similarly, prevalences of the composite primary endpoint components grew on extended monitoring, but the increases reached statistical significance only for NSVT; its prevalence went from 8% to 62% (P < .001). Prevalences rose nonsignificantly from 6% to 10% for AF and 0% to 1% for sustained ventricular tachycardia.
The incidence of NSVT during monitoring climbed fastest from day 0 through about day 19 and then rose more slowly through day 30, Dr. Caro Codón said. “It actually didn’t reach a plateau during this time period, so there is the possibility that if we had continued monitoring patients, the difference between both periods may have been even higher.”
Three variables predicted the incidence of nonsustained VT during monitoring, he said: age, atrial wall thickness, and whether there was late gadolinium enhancement at MRI.
An exploratory analysis looked at the 5-year risk of sudden cardiac death using the European Society of Cardiology HCM-SCD risk calculator recommended in guidelines. Risk assessment based on the 30-day extended monitoring period, compared with the first 24 hours of monitoring alone, predicted a significantly higher 5-year risk of sudden death, Dr. Caro Codón said.
“Even more importantly,” he added, “over 20%” of patients would have been reclassified into a higher-risk group and possibly considered for an ICD based on extended monitoring, compared to 24-hour monitoring.
However, given that more than 50% of patients were found to have NSVT during extended monitoring, Dr. Caro Codón proposed that decisions on whether to implant an ICD should not be so “binary” based on the presence or absence of symptoms, and proposed further investigations be conducted into the complete phenotype of these arrhythmias.
The study has limitations, he observed, including a relatively small size; but it was able to detect important differences between 24-hour and 30-day monitoring outcomes even with only 100 patients. It was also limited by a lack of clinical follow-up for information on endpoints like stroke, thromboembolism, and sudden cardiac death.
Extended monitoring detected more cases of NSVT in the study’s relatively low-risk HCM patients who would not generally have an indication for ICD implantation, observed Dr. van Gelder. Also, at present the prognostic value of NSVT for SCD “seems to be more important at younger age” – that is, younger than 30 years – in patients with HCM.
Dr. van Gelder echoed Dr. Caro Codón’s call for more data from prolonged monitoring to help stratify patients according to risk; she proposed NSVT frequency, duration, and rate as possible targets.
The study was supported by an unrestricted grant from Nuubo, which provided the ECG monitoring systems. Dr. Caro Codón and Dr. van Gelder reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BARCELONA – , suggests a study that questions current risk stratification practices in HCM.
In the registry study, such arrythmias were observed in about six times as many HCM patients during 30 days of ambulatory electrocardiographic monitoring as would have been identified based on the first 24 hours of the monitoring period: 65% vs. 11% of the cohort.
Also, about 62% of the patients showed NSVT at “extended” 30-day monitoring, compared with an 8% prevalence of the arrhythmia based on the more conventional ECG monitoring period of 24 hours.
Nonsustained ventricular tachycardia, an important arrhythmia used every day in clinical practice to make decisions, is “much, much more prevalent than we thought” in patients with HCM, Juan Caro Codón, MD, the study’s principal investigator, said in an interview. “We should invest in further research regarding extended ECG monitoring in these patients.”
Dr. Caro Codón, of La Paz University Hospital, Madrid, presented the findings from the TEMPO-HCM study at the European Heart Rhythm Association 2023 Congress, held in Barcelona and virtually.
Its results, he said, have implications for stratifying HCM patients according to their risk for sudden cardiac death in deciding who should be offered an implantable cardioverter-defibrillator (ICD).
The life-incidence of atrial fibrillation (AF) in patients like those in the current analysis has previously been found to be about 20%, and the life-prevalence of NSVT about 20%-30%, using traditional 24- or 48-hour Holter monitoring, Dr. Caro Codón said.
“These arrhythmias are clinically relevant events because they are linked to very meaningful clinical endpoints,” including stroke and thromboembolism, he said, “but also for sudden cardiac death.”
Extended ECG monitoring has been shown useful in the setting of cryptogenic stroke and after AF ablation, but similar findings have been scarce in HCM. Patients using personal wearable monitors such as smart watches, Dr. Caro Codón said, have come to his clinic with concerns that the devices may have signaled a problem. But the lack of relevant data leaves them without a sufficient answer.
In other findings, invited discussant Isabelle van Gelder, MD, PhD, observed after Dr. Caro Codón’s presentation that the number of patients with AF almost doubled based on extended monitoring, compared with the first 24 hours of monitoring.
Based on European Society of Cardiology guidelines from 2020, “Once clinical AF has been documented, there is a class IIA recommendation to start anticoagulation,” said Dr. van Gelder, University of Groningen, the Netherlands. “Therefore, your data really are a call for more data on screening for AF in hypertrophic cardiomyopathy patients.”
Prospective multicenter registry
The TEMPO-HCM registry includes patients with HCM and a clinical indication for standard Holter monitoring at five hospitals in Spain. It excludes patients with an HCM-like phenotype but who lack the telltale genotype, as well as those already implanted with an ICD.
Those in the current analysis underwent 30-day ECG monitoring with a small, wearable device that Dr. Caro Codón described as about 7 cm long, worn in what is essentially a T-shirt with a pocket. Patients could remove the shirt and device to bathe or go swimming, for example, and still be monitored for most of the day.
The analysis included the registry’s first 100 patients (mean age, 57 years; 78% male). Hypertension was present in 47%, 58% were on beta-blockers, 16% had prior AF or atrial flutter, and 19% were taking anticoagulants. Only 8% were on antiarrhythmic drugs, Dr. Caro Codón reported.
The patients had good functional status (68% and 29% were in NYHA class 1 and 2, respectively) and their left ventricular ejection fraction averaged 66%. Of the 71 patients who underwent MRI, 28.2% showed late gadolinium enhancement suggesting myocardial scarring.
More arrhythmias on 30-day monitoring
The primary endpoint of clinically relevant arrhythmia (AF, atrial flutter, or NSVT) was identified during the first 24 hours of monitoring in 11% of patients. The prevalence rose to 65% (P < .001) based on 30-day monitoring.
Similarly, prevalences of the composite primary endpoint components grew on extended monitoring, but the increases reached statistical significance only for NSVT; its prevalence went from 8% to 62% (P < .001). Prevalences rose nonsignificantly from 6% to 10% for AF and 0% to 1% for sustained ventricular tachycardia.
The incidence of NSVT during monitoring climbed fastest from day 0 through about day 19 and then rose more slowly through day 30, Dr. Caro Codón said. “It actually didn’t reach a plateau during this time period, so there is the possibility that if we had continued monitoring patients, the difference between both periods may have been even higher.”
Three variables predicted the incidence of nonsustained VT during monitoring, he said: age, atrial wall thickness, and whether there was late gadolinium enhancement at MRI.
An exploratory analysis looked at the 5-year risk of sudden cardiac death using the European Society of Cardiology HCM-SCD risk calculator recommended in guidelines. Risk assessment based on the 30-day extended monitoring period, compared with the first 24 hours of monitoring alone, predicted a significantly higher 5-year risk of sudden death, Dr. Caro Codón said.
“Even more importantly,” he added, “over 20%” of patients would have been reclassified into a higher-risk group and possibly considered for an ICD based on extended monitoring, compared to 24-hour monitoring.
However, given that more than 50% of patients were found to have NSVT during extended monitoring, Dr. Caro Codón proposed that decisions on whether to implant an ICD should not be so “binary” based on the presence or absence of symptoms, and proposed further investigations be conducted into the complete phenotype of these arrhythmias.
The study has limitations, he observed, including a relatively small size; but it was able to detect important differences between 24-hour and 30-day monitoring outcomes even with only 100 patients. It was also limited by a lack of clinical follow-up for information on endpoints like stroke, thromboembolism, and sudden cardiac death.
Extended monitoring detected more cases of NSVT in the study’s relatively low-risk HCM patients who would not generally have an indication for ICD implantation, observed Dr. van Gelder. Also, at present the prognostic value of NSVT for SCD “seems to be more important at younger age” – that is, younger than 30 years – in patients with HCM.
Dr. van Gelder echoed Dr. Caro Codón’s call for more data from prolonged monitoring to help stratify patients according to risk; she proposed NSVT frequency, duration, and rate as possible targets.
The study was supported by an unrestricted grant from Nuubo, which provided the ECG monitoring systems. Dr. Caro Codón and Dr. van Gelder reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BARCELONA – , suggests a study that questions current risk stratification practices in HCM.
In the registry study, such arrythmias were observed in about six times as many HCM patients during 30 days of ambulatory electrocardiographic monitoring as would have been identified based on the first 24 hours of the monitoring period: 65% vs. 11% of the cohort.
Also, about 62% of the patients showed NSVT at “extended” 30-day monitoring, compared with an 8% prevalence of the arrhythmia based on the more conventional ECG monitoring period of 24 hours.
Nonsustained ventricular tachycardia, an important arrhythmia used every day in clinical practice to make decisions, is “much, much more prevalent than we thought” in patients with HCM, Juan Caro Codón, MD, the study’s principal investigator, said in an interview. “We should invest in further research regarding extended ECG monitoring in these patients.”
Dr. Caro Codón, of La Paz University Hospital, Madrid, presented the findings from the TEMPO-HCM study at the European Heart Rhythm Association 2023 Congress, held in Barcelona and virtually.
Its results, he said, have implications for stratifying HCM patients according to their risk for sudden cardiac death in deciding who should be offered an implantable cardioverter-defibrillator (ICD).
The life-incidence of atrial fibrillation (AF) in patients like those in the current analysis has previously been found to be about 20%, and the life-prevalence of NSVT about 20%-30%, using traditional 24- or 48-hour Holter monitoring, Dr. Caro Codón said.
“These arrhythmias are clinically relevant events because they are linked to very meaningful clinical endpoints,” including stroke and thromboembolism, he said, “but also for sudden cardiac death.”
Extended ECG monitoring has been shown useful in the setting of cryptogenic stroke and after AF ablation, but similar findings have been scarce in HCM. Patients using personal wearable monitors such as smart watches, Dr. Caro Codón said, have come to his clinic with concerns that the devices may have signaled a problem. But the lack of relevant data leaves them without a sufficient answer.
In other findings, invited discussant Isabelle van Gelder, MD, PhD, observed after Dr. Caro Codón’s presentation that the number of patients with AF almost doubled based on extended monitoring, compared with the first 24 hours of monitoring.
Based on European Society of Cardiology guidelines from 2020, “Once clinical AF has been documented, there is a class IIA recommendation to start anticoagulation,” said Dr. van Gelder, University of Groningen, the Netherlands. “Therefore, your data really are a call for more data on screening for AF in hypertrophic cardiomyopathy patients.”
Prospective multicenter registry
The TEMPO-HCM registry includes patients with HCM and a clinical indication for standard Holter monitoring at five hospitals in Spain. It excludes patients with an HCM-like phenotype but who lack the telltale genotype, as well as those already implanted with an ICD.
Those in the current analysis underwent 30-day ECG monitoring with a small, wearable device that Dr. Caro Codón described as about 7 cm long, worn in what is essentially a T-shirt with a pocket. Patients could remove the shirt and device to bathe or go swimming, for example, and still be monitored for most of the day.
The analysis included the registry’s first 100 patients (mean age, 57 years; 78% male). Hypertension was present in 47%, 58% were on beta-blockers, 16% had prior AF or atrial flutter, and 19% were taking anticoagulants. Only 8% were on antiarrhythmic drugs, Dr. Caro Codón reported.
The patients had good functional status (68% and 29% were in NYHA class 1 and 2, respectively) and their left ventricular ejection fraction averaged 66%. Of the 71 patients who underwent MRI, 28.2% showed late gadolinium enhancement suggesting myocardial scarring.
More arrhythmias on 30-day monitoring
The primary endpoint of clinically relevant arrhythmia (AF, atrial flutter, or NSVT) was identified during the first 24 hours of monitoring in 11% of patients. The prevalence rose to 65% (P < .001) based on 30-day monitoring.
Similarly, prevalences of the composite primary endpoint components grew on extended monitoring, but the increases reached statistical significance only for NSVT; its prevalence went from 8% to 62% (P < .001). Prevalences rose nonsignificantly from 6% to 10% for AF and 0% to 1% for sustained ventricular tachycardia.
The incidence of NSVT during monitoring climbed fastest from day 0 through about day 19 and then rose more slowly through day 30, Dr. Caro Codón said. “It actually didn’t reach a plateau during this time period, so there is the possibility that if we had continued monitoring patients, the difference between both periods may have been even higher.”
Three variables predicted the incidence of nonsustained VT during monitoring, he said: age, atrial wall thickness, and whether there was late gadolinium enhancement at MRI.
An exploratory analysis looked at the 5-year risk of sudden cardiac death using the European Society of Cardiology HCM-SCD risk calculator recommended in guidelines. Risk assessment based on the 30-day extended monitoring period, compared with the first 24 hours of monitoring alone, predicted a significantly higher 5-year risk of sudden death, Dr. Caro Codón said.
“Even more importantly,” he added, “over 20%” of patients would have been reclassified into a higher-risk group and possibly considered for an ICD based on extended monitoring, compared to 24-hour monitoring.
However, given that more than 50% of patients were found to have NSVT during extended monitoring, Dr. Caro Codón proposed that decisions on whether to implant an ICD should not be so “binary” based on the presence or absence of symptoms, and proposed further investigations be conducted into the complete phenotype of these arrhythmias.
The study has limitations, he observed, including a relatively small size; but it was able to detect important differences between 24-hour and 30-day monitoring outcomes even with only 100 patients. It was also limited by a lack of clinical follow-up for information on endpoints like stroke, thromboembolism, and sudden cardiac death.
Extended monitoring detected more cases of NSVT in the study’s relatively low-risk HCM patients who would not generally have an indication for ICD implantation, observed Dr. van Gelder. Also, at present the prognostic value of NSVT for SCD “seems to be more important at younger age” – that is, younger than 30 years – in patients with HCM.
Dr. van Gelder echoed Dr. Caro Codón’s call for more data from prolonged monitoring to help stratify patients according to risk; she proposed NSVT frequency, duration, and rate as possible targets.
The study was supported by an unrestricted grant from Nuubo, which provided the ECG monitoring systems. Dr. Caro Codón and Dr. van Gelder reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM EHRA
Watching feasible for asymptomatic kidney stones
Many patients with asymptomatic renal stones can qualify for an active surveillance program, Swiss researchers report at the American Urological Association 2023 Annual Meeting.
Kevin Stritt, MD, chief resident in the urology department at Lausanne University Hospital, said kidney stones often pass without symptoms. But until now, data on the frequency of asymptomatic, spontaneous passage of stones have been lacking.
The new data come from the NOSTONE trial, a prospective, multicenter, double-blind, placebo-controlled randomized trial to assess the efficacy of hydrochlorothiazide in the prevention of recurrence in patients with recurrent calcium-containing kidney stones.
Dr. Stritt and colleagues evaluated the natural history of asymptomatic renal stones during a median follow-up of 35 months. “We found for the first time that a relevant number of kidney stone passages [39%] were asymptomatic, spontaneous stone passages,” Dr. Stritt told this news organization.
All asymptomatic spontaneous stone passages were analyzed in a comparison of the total number of kidney stones on low-dose, nonintravenous contrast CT imaging at the beginning and end of the 3-year follow-up.
Of the 403 stones passed spontaneously, 61% (245) were symptomatic stone passages and 39% (158) were asymptomatic stone passages, Dr. Stritt told this news organization.
Asymptomatic stones were a median size of 2.4 mm, and symptomatic stones were 2.15 mm, which was not significantly different (P = .366), according to the researchers. Dr. Stritt said the spontaneous passage of asymptomatic stones was largely influenced by a higher number of stones on CT imaging at randomization (P = .001) and a lower total stone volume (P = .001).
Ephrem Olweny, MD, an assistant professor of urology and section chief of endourology at Rush University Medical Center in Chicago, said previous studies have found that the rate of spontaneous passage of kidney stones ranges from 3% to 29%.
“But this secondary analysis of data from a prior multicenter prospective randomized trial offers higher-quality data that will be of value in guiding patient counseling,” Dr. Olweny said.
“Observation should be initially offered to these patients. However, patients should be informed that 52% are likely to develop symptoms, and some may indeed opt for preemptive surgical removal,” he added.
David Schulsinger, MD, an associate professor in the department of urology at Stony Brook (N.Y.) University Hospital, said the incidence of kidney stones has been increasing worldwide, affecting approximately 12% of men and 6% of women. Dehydration and diets high in sodium and calcium are major factors, he said.
Patients with a history of stones have a 50% risk of recurrence in the next 5 years, and an 80% risk in their lifetime, he added.
Dr. Schulsinger said the message from the Swiss study is that urologists can be “comfortable” watching small stones, those averaging 2.4 mm or less in size. “But if a patient has a 7- or 8-mm stone, you might be more inclined to manage that patient a little bit more aggressively.”
Roughly half of patients with stones less than 2 mm will pass it in about 8 days, he said.
Dr. Olweny noted that the study was a secondary analysis of data from a randomized controlled trial that evaluated the efficacy of thiazides in preventing the recurrence of calcium stones. “The original study was not specifically designed to look at asymptomatic stone passage rates for small renal stones, and therefore, the observed rates may not reflect the most precise estimates,” he said.
Dr. Stritt said his group has not studied the size limit of stones that pass spontaneously without symptoms. “This study could serve to construct recurrence prediction models based on medical history and stone burden on CT imaging. More well-designed research on this topic is urgently needed,” he said. “These results should encourage urologists to counsel patients about the possibility of an active surveillance strategy when smaller kidney stones are present.”
The author and independent commentators have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Many patients with asymptomatic renal stones can qualify for an active surveillance program, Swiss researchers report at the American Urological Association 2023 Annual Meeting.
Kevin Stritt, MD, chief resident in the urology department at Lausanne University Hospital, said kidney stones often pass without symptoms. But until now, data on the frequency of asymptomatic, spontaneous passage of stones have been lacking.
The new data come from the NOSTONE trial, a prospective, multicenter, double-blind, placebo-controlled randomized trial to assess the efficacy of hydrochlorothiazide in the prevention of recurrence in patients with recurrent calcium-containing kidney stones.
Dr. Stritt and colleagues evaluated the natural history of asymptomatic renal stones during a median follow-up of 35 months. “We found for the first time that a relevant number of kidney stone passages [39%] were asymptomatic, spontaneous stone passages,” Dr. Stritt told this news organization.
All asymptomatic spontaneous stone passages were analyzed in a comparison of the total number of kidney stones on low-dose, nonintravenous contrast CT imaging at the beginning and end of the 3-year follow-up.
Of the 403 stones passed spontaneously, 61% (245) were symptomatic stone passages and 39% (158) were asymptomatic stone passages, Dr. Stritt told this news organization.
Asymptomatic stones were a median size of 2.4 mm, and symptomatic stones were 2.15 mm, which was not significantly different (P = .366), according to the researchers. Dr. Stritt said the spontaneous passage of asymptomatic stones was largely influenced by a higher number of stones on CT imaging at randomization (P = .001) and a lower total stone volume (P = .001).
Ephrem Olweny, MD, an assistant professor of urology and section chief of endourology at Rush University Medical Center in Chicago, said previous studies have found that the rate of spontaneous passage of kidney stones ranges from 3% to 29%.
“But this secondary analysis of data from a prior multicenter prospective randomized trial offers higher-quality data that will be of value in guiding patient counseling,” Dr. Olweny said.
“Observation should be initially offered to these patients. However, patients should be informed that 52% are likely to develop symptoms, and some may indeed opt for preemptive surgical removal,” he added.
David Schulsinger, MD, an associate professor in the department of urology at Stony Brook (N.Y.) University Hospital, said the incidence of kidney stones has been increasing worldwide, affecting approximately 12% of men and 6% of women. Dehydration and diets high in sodium and calcium are major factors, he said.
Patients with a history of stones have a 50% risk of recurrence in the next 5 years, and an 80% risk in their lifetime, he added.
Dr. Schulsinger said the message from the Swiss study is that urologists can be “comfortable” watching small stones, those averaging 2.4 mm or less in size. “But if a patient has a 7- or 8-mm stone, you might be more inclined to manage that patient a little bit more aggressively.”
Roughly half of patients with stones less than 2 mm will pass it in about 8 days, he said.
Dr. Olweny noted that the study was a secondary analysis of data from a randomized controlled trial that evaluated the efficacy of thiazides in preventing the recurrence of calcium stones. “The original study was not specifically designed to look at asymptomatic stone passage rates for small renal stones, and therefore, the observed rates may not reflect the most precise estimates,” he said.
Dr. Stritt said his group has not studied the size limit of stones that pass spontaneously without symptoms. “This study could serve to construct recurrence prediction models based on medical history and stone burden on CT imaging. More well-designed research on this topic is urgently needed,” he said. “These results should encourage urologists to counsel patients about the possibility of an active surveillance strategy when smaller kidney stones are present.”
The author and independent commentators have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Many patients with asymptomatic renal stones can qualify for an active surveillance program, Swiss researchers report at the American Urological Association 2023 Annual Meeting.
Kevin Stritt, MD, chief resident in the urology department at Lausanne University Hospital, said kidney stones often pass without symptoms. But until now, data on the frequency of asymptomatic, spontaneous passage of stones have been lacking.
The new data come from the NOSTONE trial, a prospective, multicenter, double-blind, placebo-controlled randomized trial to assess the efficacy of hydrochlorothiazide in the prevention of recurrence in patients with recurrent calcium-containing kidney stones.
Dr. Stritt and colleagues evaluated the natural history of asymptomatic renal stones during a median follow-up of 35 months. “We found for the first time that a relevant number of kidney stone passages [39%] were asymptomatic, spontaneous stone passages,” Dr. Stritt told this news organization.
All asymptomatic spontaneous stone passages were analyzed in a comparison of the total number of kidney stones on low-dose, nonintravenous contrast CT imaging at the beginning and end of the 3-year follow-up.
Of the 403 stones passed spontaneously, 61% (245) were symptomatic stone passages and 39% (158) were asymptomatic stone passages, Dr. Stritt told this news organization.
Asymptomatic stones were a median size of 2.4 mm, and symptomatic stones were 2.15 mm, which was not significantly different (P = .366), according to the researchers. Dr. Stritt said the spontaneous passage of asymptomatic stones was largely influenced by a higher number of stones on CT imaging at randomization (P = .001) and a lower total stone volume (P = .001).
Ephrem Olweny, MD, an assistant professor of urology and section chief of endourology at Rush University Medical Center in Chicago, said previous studies have found that the rate of spontaneous passage of kidney stones ranges from 3% to 29%.
“But this secondary analysis of data from a prior multicenter prospective randomized trial offers higher-quality data that will be of value in guiding patient counseling,” Dr. Olweny said.
“Observation should be initially offered to these patients. However, patients should be informed that 52% are likely to develop symptoms, and some may indeed opt for preemptive surgical removal,” he added.
David Schulsinger, MD, an associate professor in the department of urology at Stony Brook (N.Y.) University Hospital, said the incidence of kidney stones has been increasing worldwide, affecting approximately 12% of men and 6% of women. Dehydration and diets high in sodium and calcium are major factors, he said.
Patients with a history of stones have a 50% risk of recurrence in the next 5 years, and an 80% risk in their lifetime, he added.
Dr. Schulsinger said the message from the Swiss study is that urologists can be “comfortable” watching small stones, those averaging 2.4 mm or less in size. “But if a patient has a 7- or 8-mm stone, you might be more inclined to manage that patient a little bit more aggressively.”
Roughly half of patients with stones less than 2 mm will pass it in about 8 days, he said.
Dr. Olweny noted that the study was a secondary analysis of data from a randomized controlled trial that evaluated the efficacy of thiazides in preventing the recurrence of calcium stones. “The original study was not specifically designed to look at asymptomatic stone passage rates for small renal stones, and therefore, the observed rates may not reflect the most precise estimates,” he said.
Dr. Stritt said his group has not studied the size limit of stones that pass spontaneously without symptoms. “This study could serve to construct recurrence prediction models based on medical history and stone burden on CT imaging. More well-designed research on this topic is urgently needed,” he said. “These results should encourage urologists to counsel patients about the possibility of an active surveillance strategy when smaller kidney stones are present.”
The author and independent commentators have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A nod to the future of AGA
CHICAGO – It’s been 125 years since the founding of the American Gastroenterological Association (AGA). It’s gone from a small organization in which gastroenterology wasn’t even a known medical specialty, to an organization that grants millions of dollars in research funding each year.
He spoke with optimism about gastroenterology’s future during his presidential address on May 8 at the annual Digestive Disease Week® (DDW) meeting in Chicago.
“I congratulate the AGA on its quasquicentennial, or 125th anniversary,” said Dr. Carethers, who is distinguished professor of medicine and vice chancellor for health sciences at the University of California, San Diego.
The AGA was founded in 1897 by Detroit-based physician Charles Aaron, MD. His passion was gastroenterology, but at that point, it wasn’t an established medical discipline. Dr. Aaron, Max Einhorn, MD, and 8 other colleagues formed the American Gastroenterological Association. Today, with nearly 16,000 members, the organization has become a driving force in improving the care of patients with gastrointestinal conditions.
Among AGA’s accomplishments since its founding: In 1940, the American Board of Internal Medicine certified gastroenterology as a subspecialty. Three years later, the first issue of Gastroenterology, the AGA’s flagship journal, was published. And, in 1971, the very first Digestive Disease Week® meeting took place.
In terms of medical advances that have been made since those early years, the list is vast: From the description of ileitis in 1932 by Burril B. Crohn, MD, in 1932 to the discovery of the hepatitis B surface antigen in 1965 and the more recent discovery of germline mutations in DNA mismatch repair genes as a cause of Lynch syndrome.
Dr. Carethers outlined goals for the future, including building a leadership team that is “reflective of our practice here in the United States,” Dr. Carethers said. Creating a culturally and gender diverse leadership team will only strengthen the organization and the practice of gastroenterology. The AGA’s first female president, Sarah Jordan, MD, was named in 1942, and since then, the AGA has been led by women and men from different ethnic backgrounds, including himself, who is AGA’s first president of African American heritage.
The AGA has committed to a number of diversity and equity objectives, including the AGA Equity Project, an initiative launched in 2020 whose goal is to achieve equity and eradicate disparities in digestive diseases with a focus on justice and equity, research and funding, workforce and leadership, recognition of the achievements of people of color, unconscious bias, and engagement with early career members.
“I am not only excited about the diversity and equity objectives within our specialty ... but also the innovation and things to come for our specialty,” Dr. Carethers said.
Securing funding for early-stage innovations in medicine can be difficult across medical disciplines, including gastroenterology. So, last year, the AGA, with Varia Ventures, launched the GI Opportunity Fund 1 to support early-stage GI-based companies. The goal is to raise $25 million for the initial fund. Through the AGA’s Center for GI Innovation and Technology and the AGA Tech Summit, early-stage companies may have new funding opportunities.
And, through the AGA Research Foundation, the organization will continue to support clinical research. Last year, $2.6 million in grants were awarded to investigators.
Dr. Carethers is a board director at Avantor, a life sciences supply company.
The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.
CHICAGO – It’s been 125 years since the founding of the American Gastroenterological Association (AGA). It’s gone from a small organization in which gastroenterology wasn’t even a known medical specialty, to an organization that grants millions of dollars in research funding each year.
He spoke with optimism about gastroenterology’s future during his presidential address on May 8 at the annual Digestive Disease Week® (DDW) meeting in Chicago.
“I congratulate the AGA on its quasquicentennial, or 125th anniversary,” said Dr. Carethers, who is distinguished professor of medicine and vice chancellor for health sciences at the University of California, San Diego.
The AGA was founded in 1897 by Detroit-based physician Charles Aaron, MD. His passion was gastroenterology, but at that point, it wasn’t an established medical discipline. Dr. Aaron, Max Einhorn, MD, and 8 other colleagues formed the American Gastroenterological Association. Today, with nearly 16,000 members, the organization has become a driving force in improving the care of patients with gastrointestinal conditions.
Among AGA’s accomplishments since its founding: In 1940, the American Board of Internal Medicine certified gastroenterology as a subspecialty. Three years later, the first issue of Gastroenterology, the AGA’s flagship journal, was published. And, in 1971, the very first Digestive Disease Week® meeting took place.
In terms of medical advances that have been made since those early years, the list is vast: From the description of ileitis in 1932 by Burril B. Crohn, MD, in 1932 to the discovery of the hepatitis B surface antigen in 1965 and the more recent discovery of germline mutations in DNA mismatch repair genes as a cause of Lynch syndrome.
Dr. Carethers outlined goals for the future, including building a leadership team that is “reflective of our practice here in the United States,” Dr. Carethers said. Creating a culturally and gender diverse leadership team will only strengthen the organization and the practice of gastroenterology. The AGA’s first female president, Sarah Jordan, MD, was named in 1942, and since then, the AGA has been led by women and men from different ethnic backgrounds, including himself, who is AGA’s first president of African American heritage.
The AGA has committed to a number of diversity and equity objectives, including the AGA Equity Project, an initiative launched in 2020 whose goal is to achieve equity and eradicate disparities in digestive diseases with a focus on justice and equity, research and funding, workforce and leadership, recognition of the achievements of people of color, unconscious bias, and engagement with early career members.
“I am not only excited about the diversity and equity objectives within our specialty ... but also the innovation and things to come for our specialty,” Dr. Carethers said.
Securing funding for early-stage innovations in medicine can be difficult across medical disciplines, including gastroenterology. So, last year, the AGA, with Varia Ventures, launched the GI Opportunity Fund 1 to support early-stage GI-based companies. The goal is to raise $25 million for the initial fund. Through the AGA’s Center for GI Innovation and Technology and the AGA Tech Summit, early-stage companies may have new funding opportunities.
And, through the AGA Research Foundation, the organization will continue to support clinical research. Last year, $2.6 million in grants were awarded to investigators.
Dr. Carethers is a board director at Avantor, a life sciences supply company.
The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.
CHICAGO – It’s been 125 years since the founding of the American Gastroenterological Association (AGA). It’s gone from a small organization in which gastroenterology wasn’t even a known medical specialty, to an organization that grants millions of dollars in research funding each year.
He spoke with optimism about gastroenterology’s future during his presidential address on May 8 at the annual Digestive Disease Week® (DDW) meeting in Chicago.
“I congratulate the AGA on its quasquicentennial, or 125th anniversary,” said Dr. Carethers, who is distinguished professor of medicine and vice chancellor for health sciences at the University of California, San Diego.
The AGA was founded in 1897 by Detroit-based physician Charles Aaron, MD. His passion was gastroenterology, but at that point, it wasn’t an established medical discipline. Dr. Aaron, Max Einhorn, MD, and 8 other colleagues formed the American Gastroenterological Association. Today, with nearly 16,000 members, the organization has become a driving force in improving the care of patients with gastrointestinal conditions.
Among AGA’s accomplishments since its founding: In 1940, the American Board of Internal Medicine certified gastroenterology as a subspecialty. Three years later, the first issue of Gastroenterology, the AGA’s flagship journal, was published. And, in 1971, the very first Digestive Disease Week® meeting took place.
In terms of medical advances that have been made since those early years, the list is vast: From the description of ileitis in 1932 by Burril B. Crohn, MD, in 1932 to the discovery of the hepatitis B surface antigen in 1965 and the more recent discovery of germline mutations in DNA mismatch repair genes as a cause of Lynch syndrome.
Dr. Carethers outlined goals for the future, including building a leadership team that is “reflective of our practice here in the United States,” Dr. Carethers said. Creating a culturally and gender diverse leadership team will only strengthen the organization and the practice of gastroenterology. The AGA’s first female president, Sarah Jordan, MD, was named in 1942, and since then, the AGA has been led by women and men from different ethnic backgrounds, including himself, who is AGA’s first president of African American heritage.
The AGA has committed to a number of diversity and equity objectives, including the AGA Equity Project, an initiative launched in 2020 whose goal is to achieve equity and eradicate disparities in digestive diseases with a focus on justice and equity, research and funding, workforce and leadership, recognition of the achievements of people of color, unconscious bias, and engagement with early career members.
“I am not only excited about the diversity and equity objectives within our specialty ... but also the innovation and things to come for our specialty,” Dr. Carethers said.
Securing funding for early-stage innovations in medicine can be difficult across medical disciplines, including gastroenterology. So, last year, the AGA, with Varia Ventures, launched the GI Opportunity Fund 1 to support early-stage GI-based companies. The goal is to raise $25 million for the initial fund. Through the AGA’s Center for GI Innovation and Technology and the AGA Tech Summit, early-stage companies may have new funding opportunities.
And, through the AGA Research Foundation, the organization will continue to support clinical research. Last year, $2.6 million in grants were awarded to investigators.
Dr. Carethers is a board director at Avantor, a life sciences supply company.
The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.
AT DDW 2023