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Hyperbaric oxygen may improve heart function in long COVID
.
Patients with reduced left ventricular global longitudinal strain (GLS) at baseline who received HBOT had a significant increase in GLS, compared with those who received sham treatment.
GLS is a measure of systolic function that is thought to be a predictor of heart failure–related outcomes.
The study also showed that global work efficiency (GWE) and the global work index (GWI) increased in HBOT-treated patients, though not significantly.
“HBOT is an effective treatment for diabetic foot ulcers, decompression sickness in divers, and other conditions, such as cognitive impairment after stroke,” Marina Leitman, MD, of the Sackler School of Medicine, Tel Aviv, said in an interview. Her team also studied HBOT in asymptomatic older patients and found that the treatment seemed to improve left ventricular end systolic function.
“We should open our minds to thinking about this treatment for another indication,” she said. “That is the basis of precision medicine. We have this treatment and know it can be effective for cardiac pathology.
“Now we can say that post-COVID syndrome patients probably should be evaluated with echocardiography and GLS, which is the main parameter that showed improvement in our study,” she added. “If GLS is below normal values, these patients can benefit from HBOT, although additional research is needed to determine the optimal number of sessions.”
Dr. Leitman presented the study at the European Association of Cardiovascular Imaging 2023, a scientific congress of the European Society of Cardiology.
Biomarker changes
The study enrolled 60 hospitalized and nonhospitalized post-COVID syndrome patients with ongoing symptoms for at least 3 months after having mild to moderate symptomatic COVID-19.
Participants were randomized to receive HBOT or a sham procedure five times per week for 8 weeks, for a total of 40 sessions. They underwent echocardiography at baseline and 1-3 weeks after the final session to assess GLS.
The HBOT group received 100% oxygen through a mask at a pressure of two atmospheres for 90 minutes, with 5-minute air breaks every 20 minutes.
The sham group received 21% oxygen by mask at one atmosphere for 90 minutes.
At baseline, 29 participants (48%) had reduced GLS, despite having a normal ejection fraction, Dr. Leitman said. Of those, 16 (53%) were in the HBOT group and 13 (43%) were in the sham group.
The average GLS at baseline across all participants was –17.8%; a normal value is about –20%.
In the HBOT group, GLS increased significantly from –17.8% at baseline to –20.2% after HBOT. In the sham group, GLS was –17.8% at baseline and –19.1% at the end of the study, with no statistically significant difference between the two measurements.
In addition, GWE increased overall after HBOT from 96.3 to 97.1.
Dr. Leitman’s poster showed GLS and myocardial work indices before and after HBOT in a 45-year-old patient. Prior to treatment, GLS was –19%; GWE was 96%; and GWI was 1,833 mm Hg.
After HBOT treatment, GLS was –22%; GWE, 98%; and GWI, 1,911 mm Hg.
Clinical relevance unclear
Scott Gorenstein, MD, associate professor in the department of surgery and medical director of wound care and hyperbaric medicine at NYU Langone–Long Island, New York, commented on the study for this news organization.
“The approach certainly warrants studying, but the benefit is difficult to assess,” he said. “We still don’t understand the mechanism of long COVID, so it’s difficult to go from there to say that HBOT will be an effective therapy.”
That said, he added, “This is probably the best study I’ve seen in that it’s a randomized controlled trial, rather than a case series.”
Nevertheless, he noted, “We have no idea from this study whether the change in GLS is clinically relevant. As a clinician, I can’t now say that HBOT is going to improve heart failure secondary to long COVID. We don’t know whether the participants were New York heart failure class 3 or 4, for example, and all of a sudden went from really sick to really good.”
“There are many interventions that may change markers of cardiac function or inflammation,” he said. “But if they don’t make a difference in quantity or quality of life, is the treatment really valuable?”
Dr. Gorenstein said he would have no problem treating a patient with mild to moderate COVID-related heart failure with HBOT, since his own team’s study conducted near the outset of the pandemic showed it was safe. “But HBOT is an expensive treatment in the U.S. and there still are some risks and side effects, albeit very, very low.”
The study received no funding. Dr. Leitman and Dr. Gorenstein have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
.
Patients with reduced left ventricular global longitudinal strain (GLS) at baseline who received HBOT had a significant increase in GLS, compared with those who received sham treatment.
GLS is a measure of systolic function that is thought to be a predictor of heart failure–related outcomes.
The study also showed that global work efficiency (GWE) and the global work index (GWI) increased in HBOT-treated patients, though not significantly.
“HBOT is an effective treatment for diabetic foot ulcers, decompression sickness in divers, and other conditions, such as cognitive impairment after stroke,” Marina Leitman, MD, of the Sackler School of Medicine, Tel Aviv, said in an interview. Her team also studied HBOT in asymptomatic older patients and found that the treatment seemed to improve left ventricular end systolic function.
“We should open our minds to thinking about this treatment for another indication,” she said. “That is the basis of precision medicine. We have this treatment and know it can be effective for cardiac pathology.
“Now we can say that post-COVID syndrome patients probably should be evaluated with echocardiography and GLS, which is the main parameter that showed improvement in our study,” she added. “If GLS is below normal values, these patients can benefit from HBOT, although additional research is needed to determine the optimal number of sessions.”
Dr. Leitman presented the study at the European Association of Cardiovascular Imaging 2023, a scientific congress of the European Society of Cardiology.
Biomarker changes
The study enrolled 60 hospitalized and nonhospitalized post-COVID syndrome patients with ongoing symptoms for at least 3 months after having mild to moderate symptomatic COVID-19.
Participants were randomized to receive HBOT or a sham procedure five times per week for 8 weeks, for a total of 40 sessions. They underwent echocardiography at baseline and 1-3 weeks after the final session to assess GLS.
The HBOT group received 100% oxygen through a mask at a pressure of two atmospheres for 90 minutes, with 5-minute air breaks every 20 minutes.
The sham group received 21% oxygen by mask at one atmosphere for 90 minutes.
At baseline, 29 participants (48%) had reduced GLS, despite having a normal ejection fraction, Dr. Leitman said. Of those, 16 (53%) were in the HBOT group and 13 (43%) were in the sham group.
The average GLS at baseline across all participants was –17.8%; a normal value is about –20%.
In the HBOT group, GLS increased significantly from –17.8% at baseline to –20.2% after HBOT. In the sham group, GLS was –17.8% at baseline and –19.1% at the end of the study, with no statistically significant difference between the two measurements.
In addition, GWE increased overall after HBOT from 96.3 to 97.1.
Dr. Leitman’s poster showed GLS and myocardial work indices before and after HBOT in a 45-year-old patient. Prior to treatment, GLS was –19%; GWE was 96%; and GWI was 1,833 mm Hg.
After HBOT treatment, GLS was –22%; GWE, 98%; and GWI, 1,911 mm Hg.
Clinical relevance unclear
Scott Gorenstein, MD, associate professor in the department of surgery and medical director of wound care and hyperbaric medicine at NYU Langone–Long Island, New York, commented on the study for this news organization.
“The approach certainly warrants studying, but the benefit is difficult to assess,” he said. “We still don’t understand the mechanism of long COVID, so it’s difficult to go from there to say that HBOT will be an effective therapy.”
That said, he added, “This is probably the best study I’ve seen in that it’s a randomized controlled trial, rather than a case series.”
Nevertheless, he noted, “We have no idea from this study whether the change in GLS is clinically relevant. As a clinician, I can’t now say that HBOT is going to improve heart failure secondary to long COVID. We don’t know whether the participants were New York heart failure class 3 or 4, for example, and all of a sudden went from really sick to really good.”
“There are many interventions that may change markers of cardiac function or inflammation,” he said. “But if they don’t make a difference in quantity or quality of life, is the treatment really valuable?”
Dr. Gorenstein said he would have no problem treating a patient with mild to moderate COVID-related heart failure with HBOT, since his own team’s study conducted near the outset of the pandemic showed it was safe. “But HBOT is an expensive treatment in the U.S. and there still are some risks and side effects, albeit very, very low.”
The study received no funding. Dr. Leitman and Dr. Gorenstein have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
.
Patients with reduced left ventricular global longitudinal strain (GLS) at baseline who received HBOT had a significant increase in GLS, compared with those who received sham treatment.
GLS is a measure of systolic function that is thought to be a predictor of heart failure–related outcomes.
The study also showed that global work efficiency (GWE) and the global work index (GWI) increased in HBOT-treated patients, though not significantly.
“HBOT is an effective treatment for diabetic foot ulcers, decompression sickness in divers, and other conditions, such as cognitive impairment after stroke,” Marina Leitman, MD, of the Sackler School of Medicine, Tel Aviv, said in an interview. Her team also studied HBOT in asymptomatic older patients and found that the treatment seemed to improve left ventricular end systolic function.
“We should open our minds to thinking about this treatment for another indication,” she said. “That is the basis of precision medicine. We have this treatment and know it can be effective for cardiac pathology.
“Now we can say that post-COVID syndrome patients probably should be evaluated with echocardiography and GLS, which is the main parameter that showed improvement in our study,” she added. “If GLS is below normal values, these patients can benefit from HBOT, although additional research is needed to determine the optimal number of sessions.”
Dr. Leitman presented the study at the European Association of Cardiovascular Imaging 2023, a scientific congress of the European Society of Cardiology.
Biomarker changes
The study enrolled 60 hospitalized and nonhospitalized post-COVID syndrome patients with ongoing symptoms for at least 3 months after having mild to moderate symptomatic COVID-19.
Participants were randomized to receive HBOT or a sham procedure five times per week for 8 weeks, for a total of 40 sessions. They underwent echocardiography at baseline and 1-3 weeks after the final session to assess GLS.
The HBOT group received 100% oxygen through a mask at a pressure of two atmospheres for 90 minutes, with 5-minute air breaks every 20 minutes.
The sham group received 21% oxygen by mask at one atmosphere for 90 minutes.
At baseline, 29 participants (48%) had reduced GLS, despite having a normal ejection fraction, Dr. Leitman said. Of those, 16 (53%) were in the HBOT group and 13 (43%) were in the sham group.
The average GLS at baseline across all participants was –17.8%; a normal value is about –20%.
In the HBOT group, GLS increased significantly from –17.8% at baseline to –20.2% after HBOT. In the sham group, GLS was –17.8% at baseline and –19.1% at the end of the study, with no statistically significant difference between the two measurements.
In addition, GWE increased overall after HBOT from 96.3 to 97.1.
Dr. Leitman’s poster showed GLS and myocardial work indices before and after HBOT in a 45-year-old patient. Prior to treatment, GLS was –19%; GWE was 96%; and GWI was 1,833 mm Hg.
After HBOT treatment, GLS was –22%; GWE, 98%; and GWI, 1,911 mm Hg.
Clinical relevance unclear
Scott Gorenstein, MD, associate professor in the department of surgery and medical director of wound care and hyperbaric medicine at NYU Langone–Long Island, New York, commented on the study for this news organization.
“The approach certainly warrants studying, but the benefit is difficult to assess,” he said. “We still don’t understand the mechanism of long COVID, so it’s difficult to go from there to say that HBOT will be an effective therapy.”
That said, he added, “This is probably the best study I’ve seen in that it’s a randomized controlled trial, rather than a case series.”
Nevertheless, he noted, “We have no idea from this study whether the change in GLS is clinically relevant. As a clinician, I can’t now say that HBOT is going to improve heart failure secondary to long COVID. We don’t know whether the participants were New York heart failure class 3 or 4, for example, and all of a sudden went from really sick to really good.”
“There are many interventions that may change markers of cardiac function or inflammation,” he said. “But if they don’t make a difference in quantity or quality of life, is the treatment really valuable?”
Dr. Gorenstein said he would have no problem treating a patient with mild to moderate COVID-related heart failure with HBOT, since his own team’s study conducted near the outset of the pandemic showed it was safe. “But HBOT is an expensive treatment in the U.S. and there still are some risks and side effects, albeit very, very low.”
The study received no funding. Dr. Leitman and Dr. Gorenstein have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM EACVI 2023
Evolve your website
The past few years have seen major transformations in the way health care websites operate and interact with patients. .
In mid-2018, a major Google algorithm change, known to the IT community as the “Medic Update,” significantly changed search criteria for most health and wellness websites. Another big update went live in late 2021. Websites that have not evolved with these changes have dropped in search rankings and provide a poorer user experience all around.
Many potential patients are searching for your services online, so your website cannot be an afterthought. Not only does it need to be designed with your target audience in mind, but it is also important to consider the metrics Google and other search engines now use when assessing the quality of your website so that patients will find it in the first place.
Here are some features that you (or your website company) need to prioritize to keep your site current and atop search results in 2023 and beyond.
Begin with an understandable URL. Search engines use URLs to determine how well your site, or a portion of it, matches search criteria. URLs also need to make sense to searchers, especially when they link specific areas of expertise (more on that in a minute). For example, a URL like “jonesdermatology.com/?p=89021” is meaningless to anyone except programmers; but “jonesdermatology.com/psoriasistreatments” obviously leads to a page about psoriasis treatments. Search engines look for not only the most relevant, but also the most helpful and user-friendly answers to a user’s query.
Incidentally, if the URL for your site is not your own name, you should register your name as a separate domain name – even if you never use it – to be sure that a trickster or troll, or someone with the same name but a bad reputation, doesn’t get it.
Continue with a good meta description. That’s the grayish text that follows the title and URL in search results. Searchers will read it to confirm that your site is what they seek, so make sure it describes exactly what you do, including any areas of special expertise.
Make your practice approachable with photos. New patients are more comfortable when they know what you look like, so real photos of you and your staff are always more effective than stock photos of models. Photos or a video tour of your office will reassure prospective patients that they will be visiting a clean, modern, professional facility.
Describe your principal services in detail. You never know which specific service a prospective patient is searching for, so describe everything you offer. Don’t try to summarize everything on a single page; relevance is determined by how deeply a topic is covered, so each principal service should have a detailed description on its own page. Not only will your skills become more visible to search engines, but you can also use the space to enumerate your qualifications and expertise in each area. Whenever possible, write your descriptions in question-and-answer form. Searchers tend to ask questions (“what is the best ... ?”), particularly in voice searches. Search engines increasingly value sites that ask and answer common questions.
Make your site interactive. “Interactivity” is a major buzzword in modern search engine parlance. Once searchers make an appointment, they stop searching. If they have to wait until the next day to call your office, they may keep looking – and might find a competitor with online scheduling. HIPAA-compliant chatbots, secure messaging, and online patient portals to access medical records, lab results, and other important information will also set your site apart.
Testimonials are essential. Amazon.com taught us that candid reviews from customers go a long way toward building the trust necessary to buy products and services, and nowhere is that truer than for medical services. According to one study, when it comes to finding a doctor, 88% of people trust online reviews as much as a personal recommendation. Loyal patients will be happy to write you glowing reviews; feature them prominently.
How does your site look on small screens? More than half of all searches are now made on smartphones, so the more mobile-friendly your site is, the higher it will be ranked. Prospective patients who are forced to scroll forever, or zoom in to tap a link, are likely to become frustrated and move on. Mobile searchers prefer sites that provide the best experience for the least amount of effort, and rankings tend to reflect that preference. You can test how easily a visitor can use your website on a mobile device with Google’s free Mobile-Friendly Test..
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
The past few years have seen major transformations in the way health care websites operate and interact with patients. .
In mid-2018, a major Google algorithm change, known to the IT community as the “Medic Update,” significantly changed search criteria for most health and wellness websites. Another big update went live in late 2021. Websites that have not evolved with these changes have dropped in search rankings and provide a poorer user experience all around.
Many potential patients are searching for your services online, so your website cannot be an afterthought. Not only does it need to be designed with your target audience in mind, but it is also important to consider the metrics Google and other search engines now use when assessing the quality of your website so that patients will find it in the first place.
Here are some features that you (or your website company) need to prioritize to keep your site current and atop search results in 2023 and beyond.
Begin with an understandable URL. Search engines use URLs to determine how well your site, or a portion of it, matches search criteria. URLs also need to make sense to searchers, especially when they link specific areas of expertise (more on that in a minute). For example, a URL like “jonesdermatology.com/?p=89021” is meaningless to anyone except programmers; but “jonesdermatology.com/psoriasistreatments” obviously leads to a page about psoriasis treatments. Search engines look for not only the most relevant, but also the most helpful and user-friendly answers to a user’s query.
Incidentally, if the URL for your site is not your own name, you should register your name as a separate domain name – even if you never use it – to be sure that a trickster or troll, or someone with the same name but a bad reputation, doesn’t get it.
Continue with a good meta description. That’s the grayish text that follows the title and URL in search results. Searchers will read it to confirm that your site is what they seek, so make sure it describes exactly what you do, including any areas of special expertise.
Make your practice approachable with photos. New patients are more comfortable when they know what you look like, so real photos of you and your staff are always more effective than stock photos of models. Photos or a video tour of your office will reassure prospective patients that they will be visiting a clean, modern, professional facility.
Describe your principal services in detail. You never know which specific service a prospective patient is searching for, so describe everything you offer. Don’t try to summarize everything on a single page; relevance is determined by how deeply a topic is covered, so each principal service should have a detailed description on its own page. Not only will your skills become more visible to search engines, but you can also use the space to enumerate your qualifications and expertise in each area. Whenever possible, write your descriptions in question-and-answer form. Searchers tend to ask questions (“what is the best ... ?”), particularly in voice searches. Search engines increasingly value sites that ask and answer common questions.
Make your site interactive. “Interactivity” is a major buzzword in modern search engine parlance. Once searchers make an appointment, they stop searching. If they have to wait until the next day to call your office, they may keep looking – and might find a competitor with online scheduling. HIPAA-compliant chatbots, secure messaging, and online patient portals to access medical records, lab results, and other important information will also set your site apart.
Testimonials are essential. Amazon.com taught us that candid reviews from customers go a long way toward building the trust necessary to buy products and services, and nowhere is that truer than for medical services. According to one study, when it comes to finding a doctor, 88% of people trust online reviews as much as a personal recommendation. Loyal patients will be happy to write you glowing reviews; feature them prominently.
How does your site look on small screens? More than half of all searches are now made on smartphones, so the more mobile-friendly your site is, the higher it will be ranked. Prospective patients who are forced to scroll forever, or zoom in to tap a link, are likely to become frustrated and move on. Mobile searchers prefer sites that provide the best experience for the least amount of effort, and rankings tend to reflect that preference. You can test how easily a visitor can use your website on a mobile device with Google’s free Mobile-Friendly Test..
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
The past few years have seen major transformations in the way health care websites operate and interact with patients. .
In mid-2018, a major Google algorithm change, known to the IT community as the “Medic Update,” significantly changed search criteria for most health and wellness websites. Another big update went live in late 2021. Websites that have not evolved with these changes have dropped in search rankings and provide a poorer user experience all around.
Many potential patients are searching for your services online, so your website cannot be an afterthought. Not only does it need to be designed with your target audience in mind, but it is also important to consider the metrics Google and other search engines now use when assessing the quality of your website so that patients will find it in the first place.
Here are some features that you (or your website company) need to prioritize to keep your site current and atop search results in 2023 and beyond.
Begin with an understandable URL. Search engines use URLs to determine how well your site, or a portion of it, matches search criteria. URLs also need to make sense to searchers, especially when they link specific areas of expertise (more on that in a minute). For example, a URL like “jonesdermatology.com/?p=89021” is meaningless to anyone except programmers; but “jonesdermatology.com/psoriasistreatments” obviously leads to a page about psoriasis treatments. Search engines look for not only the most relevant, but also the most helpful and user-friendly answers to a user’s query.
Incidentally, if the URL for your site is not your own name, you should register your name as a separate domain name – even if you never use it – to be sure that a trickster or troll, or someone with the same name but a bad reputation, doesn’t get it.
Continue with a good meta description. That’s the grayish text that follows the title and URL in search results. Searchers will read it to confirm that your site is what they seek, so make sure it describes exactly what you do, including any areas of special expertise.
Make your practice approachable with photos. New patients are more comfortable when they know what you look like, so real photos of you and your staff are always more effective than stock photos of models. Photos or a video tour of your office will reassure prospective patients that they will be visiting a clean, modern, professional facility.
Describe your principal services in detail. You never know which specific service a prospective patient is searching for, so describe everything you offer. Don’t try to summarize everything on a single page; relevance is determined by how deeply a topic is covered, so each principal service should have a detailed description on its own page. Not only will your skills become more visible to search engines, but you can also use the space to enumerate your qualifications and expertise in each area. Whenever possible, write your descriptions in question-and-answer form. Searchers tend to ask questions (“what is the best ... ?”), particularly in voice searches. Search engines increasingly value sites that ask and answer common questions.
Make your site interactive. “Interactivity” is a major buzzword in modern search engine parlance. Once searchers make an appointment, they stop searching. If they have to wait until the next day to call your office, they may keep looking – and might find a competitor with online scheduling. HIPAA-compliant chatbots, secure messaging, and online patient portals to access medical records, lab results, and other important information will also set your site apart.
Testimonials are essential. Amazon.com taught us that candid reviews from customers go a long way toward building the trust necessary to buy products and services, and nowhere is that truer than for medical services. According to one study, when it comes to finding a doctor, 88% of people trust online reviews as much as a personal recommendation. Loyal patients will be happy to write you glowing reviews; feature them prominently.
How does your site look on small screens? More than half of all searches are now made on smartphones, so the more mobile-friendly your site is, the higher it will be ranked. Prospective patients who are forced to scroll forever, or zoom in to tap a link, are likely to become frustrated and move on. Mobile searchers prefer sites that provide the best experience for the least amount of effort, and rankings tend to reflect that preference. You can test how easily a visitor can use your website on a mobile device with Google’s free Mobile-Friendly Test..
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
CGM completes picture of A1c in type 2 diabetes
in a post hoc analysis of the SWITCH PRO clinical trial.
TIR was inversely related to A1c, with the strongest correlation following treatment intensification.
However, “there was a wide scatter of data, indicating that TIR (and other metrics) provides information about glycemic control that cannot be discerned from A1c alone, and which at least complements it,” Ronald M. Goldenberg, MD, from LMC Diabetes & Endocrinology in Thornhill, Ont., and colleagues write in their article published in Diabetes Therapy.
Other work has shown that more than a third of people with type 2 diabetes are not achieving the internationally recommended A1c target of < 7% to 8.5%, they note.
When used with A1c, CGM data – such as TIR, time below range (TBR), and time above range (TAR) – “provide a more complete picture of glucose levels throughout the day and night,” they write.
“This may help empower people with diabetes to better manage their condition, giving them practical insights into the factors driving daily fluctuations in glucose levels, such as diet, exercise, insulin dosage, and insulin timing,” they add. “These metrics may also be used to inform treatment decisions by health care professionals.”
“Ultimately,” the researchers conclude, “it is hoped that the use of these new metrics should lead to an improved quality of glycemic control and, in turn, to a reduction in the number of diabetes-related complications.”
‘Important study’
Invited to comment, Celeste C. Thomas, MD, who was not involved with the research, said: “This study is important because it is consistent with previous analyses that found a correlation between TIR and A1c.”
But, “I was surprised by the scatter plots which identified participants with TIR of 70% that also had A1c > 9%,” she added. “This highlights the importance of using multiple glycemic metrics to understand an individual’s risk for diabetes complications and to be aware of the limitations of the metrics.”
Dr. Thomas, from the University of Chicago, also noted that CGM is used in endocrinology clinics and increasingly in primary care clinics, “often to determine glycemic patterns to optimize therapeutic management but also to review TIR and, importantly, time below range to reduce the incidence of hypoglycemia.”
And people with type 2 diabetes are using CGM, Dr. Thomas noted, to understand their individual responses to medications, food choices, sleep quality and duration, exercise, and other day-to-day variables that affect glucose levels. “In my clinical practice, the information provided by personal CGM is empowering,” she said.
Effective April 4, 2023, Medicare “allows for the coverage of CGM in patients [with type 2 diabetes] treated with one injection of insulin daily and those not taking insulin but with a history of hypoglycemia,” Dr. Thomas noted, whereas “previously, patients needed to be prescribed at least three injections of insulin daily. Other insurers will hopefully soon follow.”
“I foresee CGM and TIR being widely used in clinical practice for people living with type 2 diabetes,” she said, “especially those who have ever had an A1c over 8%, those with a history of hypoglycemia, and those treated with medications that are known to cause hypoglycemia.”
How does TIR compare with A1c?
Dr. Goldenberg and colleagues set out to better understand how the emerging TIR metric compares with the traditional A1c value.
They performed a post-hoc analysis of data from the phase 4 SWITCH PRO study of basal insulin–treated patients with type 2 diabetes with at least one risk factor for hypoglycemia.
The patients were treated with insulin degludec or glargine 100 during a 16-week titration and 2-week maintenance phase, and then crossed over to the other treatment for the same time periods.
Glycemic control was evaluated using a blinded professional CGM (Abbott Freestyle Libro Pro). The primary outcome was TIR, which was defined as the percentage of time spent in the blood glucose range of 70-180 mg/dL.
There were 419 participants in the full analysis. Patients were a mean age of 63 and 48% were men. They had a mean body mass index of 32 kg/m2 and had diabetes for a mean of 15 years.
There was a moderate inverse linear correlation between TIR and A1c at baseline, which became stronger following treatment intensification during the maintenance periods in the full cohort, and in a subgroup of patients with median A1c ≥ 7.5% (212 patients).
This correlation between TIR and A1c was poorer in the subgroup of patients with baseline median A1c < 7.5% (307 patients).
The data were widely scattered, “supporting the premise that A1c and TIR can be relatively crude surrogates of each other when it comes to individual patients,” Dr. Goldenberg and colleagues note.
Where individual patients have both low A1c and low TIR values, this might indicate frequent episodes of hypoglycemia.
A few individual patients had TIR > 70% but A1c approaching 9%. These patients may have different red blood cell physiology whereby A1c does not reflect average glycemic values, the researchers suggest.
The study was sponsored by Novo Nordisk and several authors are Novo Nordisk employees. The complete author disclosures are listed with the article. Dr. Thomas has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
in a post hoc analysis of the SWITCH PRO clinical trial.
TIR was inversely related to A1c, with the strongest correlation following treatment intensification.
However, “there was a wide scatter of data, indicating that TIR (and other metrics) provides information about glycemic control that cannot be discerned from A1c alone, and which at least complements it,” Ronald M. Goldenberg, MD, from LMC Diabetes & Endocrinology in Thornhill, Ont., and colleagues write in their article published in Diabetes Therapy.
Other work has shown that more than a third of people with type 2 diabetes are not achieving the internationally recommended A1c target of < 7% to 8.5%, they note.
When used with A1c, CGM data – such as TIR, time below range (TBR), and time above range (TAR) – “provide a more complete picture of glucose levels throughout the day and night,” they write.
“This may help empower people with diabetes to better manage their condition, giving them practical insights into the factors driving daily fluctuations in glucose levels, such as diet, exercise, insulin dosage, and insulin timing,” they add. “These metrics may also be used to inform treatment decisions by health care professionals.”
“Ultimately,” the researchers conclude, “it is hoped that the use of these new metrics should lead to an improved quality of glycemic control and, in turn, to a reduction in the number of diabetes-related complications.”
‘Important study’
Invited to comment, Celeste C. Thomas, MD, who was not involved with the research, said: “This study is important because it is consistent with previous analyses that found a correlation between TIR and A1c.”
But, “I was surprised by the scatter plots which identified participants with TIR of 70% that also had A1c > 9%,” she added. “This highlights the importance of using multiple glycemic metrics to understand an individual’s risk for diabetes complications and to be aware of the limitations of the metrics.”
Dr. Thomas, from the University of Chicago, also noted that CGM is used in endocrinology clinics and increasingly in primary care clinics, “often to determine glycemic patterns to optimize therapeutic management but also to review TIR and, importantly, time below range to reduce the incidence of hypoglycemia.”
And people with type 2 diabetes are using CGM, Dr. Thomas noted, to understand their individual responses to medications, food choices, sleep quality and duration, exercise, and other day-to-day variables that affect glucose levels. “In my clinical practice, the information provided by personal CGM is empowering,” she said.
Effective April 4, 2023, Medicare “allows for the coverage of CGM in patients [with type 2 diabetes] treated with one injection of insulin daily and those not taking insulin but with a history of hypoglycemia,” Dr. Thomas noted, whereas “previously, patients needed to be prescribed at least three injections of insulin daily. Other insurers will hopefully soon follow.”
“I foresee CGM and TIR being widely used in clinical practice for people living with type 2 diabetes,” she said, “especially those who have ever had an A1c over 8%, those with a history of hypoglycemia, and those treated with medications that are known to cause hypoglycemia.”
How does TIR compare with A1c?
Dr. Goldenberg and colleagues set out to better understand how the emerging TIR metric compares with the traditional A1c value.
They performed a post-hoc analysis of data from the phase 4 SWITCH PRO study of basal insulin–treated patients with type 2 diabetes with at least one risk factor for hypoglycemia.
The patients were treated with insulin degludec or glargine 100 during a 16-week titration and 2-week maintenance phase, and then crossed over to the other treatment for the same time periods.
Glycemic control was evaluated using a blinded professional CGM (Abbott Freestyle Libro Pro). The primary outcome was TIR, which was defined as the percentage of time spent in the blood glucose range of 70-180 mg/dL.
There were 419 participants in the full analysis. Patients were a mean age of 63 and 48% were men. They had a mean body mass index of 32 kg/m2 and had diabetes for a mean of 15 years.
There was a moderate inverse linear correlation between TIR and A1c at baseline, which became stronger following treatment intensification during the maintenance periods in the full cohort, and in a subgroup of patients with median A1c ≥ 7.5% (212 patients).
This correlation between TIR and A1c was poorer in the subgroup of patients with baseline median A1c < 7.5% (307 patients).
The data were widely scattered, “supporting the premise that A1c and TIR can be relatively crude surrogates of each other when it comes to individual patients,” Dr. Goldenberg and colleagues note.
Where individual patients have both low A1c and low TIR values, this might indicate frequent episodes of hypoglycemia.
A few individual patients had TIR > 70% but A1c approaching 9%. These patients may have different red blood cell physiology whereby A1c does not reflect average glycemic values, the researchers suggest.
The study was sponsored by Novo Nordisk and several authors are Novo Nordisk employees. The complete author disclosures are listed with the article. Dr. Thomas has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
in a post hoc analysis of the SWITCH PRO clinical trial.
TIR was inversely related to A1c, with the strongest correlation following treatment intensification.
However, “there was a wide scatter of data, indicating that TIR (and other metrics) provides information about glycemic control that cannot be discerned from A1c alone, and which at least complements it,” Ronald M. Goldenberg, MD, from LMC Diabetes & Endocrinology in Thornhill, Ont., and colleagues write in their article published in Diabetes Therapy.
Other work has shown that more than a third of people with type 2 diabetes are not achieving the internationally recommended A1c target of < 7% to 8.5%, they note.
When used with A1c, CGM data – such as TIR, time below range (TBR), and time above range (TAR) – “provide a more complete picture of glucose levels throughout the day and night,” they write.
“This may help empower people with diabetes to better manage their condition, giving them practical insights into the factors driving daily fluctuations in glucose levels, such as diet, exercise, insulin dosage, and insulin timing,” they add. “These metrics may also be used to inform treatment decisions by health care professionals.”
“Ultimately,” the researchers conclude, “it is hoped that the use of these new metrics should lead to an improved quality of glycemic control and, in turn, to a reduction in the number of diabetes-related complications.”
‘Important study’
Invited to comment, Celeste C. Thomas, MD, who was not involved with the research, said: “This study is important because it is consistent with previous analyses that found a correlation between TIR and A1c.”
But, “I was surprised by the scatter plots which identified participants with TIR of 70% that also had A1c > 9%,” she added. “This highlights the importance of using multiple glycemic metrics to understand an individual’s risk for diabetes complications and to be aware of the limitations of the metrics.”
Dr. Thomas, from the University of Chicago, also noted that CGM is used in endocrinology clinics and increasingly in primary care clinics, “often to determine glycemic patterns to optimize therapeutic management but also to review TIR and, importantly, time below range to reduce the incidence of hypoglycemia.”
And people with type 2 diabetes are using CGM, Dr. Thomas noted, to understand their individual responses to medications, food choices, sleep quality and duration, exercise, and other day-to-day variables that affect glucose levels. “In my clinical practice, the information provided by personal CGM is empowering,” she said.
Effective April 4, 2023, Medicare “allows for the coverage of CGM in patients [with type 2 diabetes] treated with one injection of insulin daily and those not taking insulin but with a history of hypoglycemia,” Dr. Thomas noted, whereas “previously, patients needed to be prescribed at least three injections of insulin daily. Other insurers will hopefully soon follow.”
“I foresee CGM and TIR being widely used in clinical practice for people living with type 2 diabetes,” she said, “especially those who have ever had an A1c over 8%, those with a history of hypoglycemia, and those treated with medications that are known to cause hypoglycemia.”
How does TIR compare with A1c?
Dr. Goldenberg and colleagues set out to better understand how the emerging TIR metric compares with the traditional A1c value.
They performed a post-hoc analysis of data from the phase 4 SWITCH PRO study of basal insulin–treated patients with type 2 diabetes with at least one risk factor for hypoglycemia.
The patients were treated with insulin degludec or glargine 100 during a 16-week titration and 2-week maintenance phase, and then crossed over to the other treatment for the same time periods.
Glycemic control was evaluated using a blinded professional CGM (Abbott Freestyle Libro Pro). The primary outcome was TIR, which was defined as the percentage of time spent in the blood glucose range of 70-180 mg/dL.
There were 419 participants in the full analysis. Patients were a mean age of 63 and 48% were men. They had a mean body mass index of 32 kg/m2 and had diabetes for a mean of 15 years.
There was a moderate inverse linear correlation between TIR and A1c at baseline, which became stronger following treatment intensification during the maintenance periods in the full cohort, and in a subgroup of patients with median A1c ≥ 7.5% (212 patients).
This correlation between TIR and A1c was poorer in the subgroup of patients with baseline median A1c < 7.5% (307 patients).
The data were widely scattered, “supporting the premise that A1c and TIR can be relatively crude surrogates of each other when it comes to individual patients,” Dr. Goldenberg and colleagues note.
Where individual patients have both low A1c and low TIR values, this might indicate frequent episodes of hypoglycemia.
A few individual patients had TIR > 70% but A1c approaching 9%. These patients may have different red blood cell physiology whereby A1c does not reflect average glycemic values, the researchers suggest.
The study was sponsored by Novo Nordisk and several authors are Novo Nordisk employees. The complete author disclosures are listed with the article. Dr. Thomas has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM DIABETES THERAPY
Endovascular approach best for below-knee limb-threatening ischemia?
in a new randomized trial.
In the Bypass Versus Angioplasty in Severe Ischaemia of the Leg (BASIL-2) trial, patients who received vein bypass as the first approach were more likely to require a major amputation or to die during follow-up than patients who were randomly assigned to the endovascular approach as first strategy.
“Our findings suggest that a best endovascular treatment first revascularization strategy is associated with a better amputation-free survival. This is mainly because the best endovascular treatment first revascularization strategy resulted in fewer deaths. Limb-related outcomes were similar between groups,” the authors stated.
“The BASIL-2 trial has produced a statistically robust and clinically meaningful result that is likely to have an influence on the management of chronic limb-threatening ischemia worldwide,” added the study’s chief investigator, Andrew Bradbury, MD, professor of vascular surgery at the University of Birmingham (England).
However, the results of the BASIL-2 trial conflict with those from two previous studies – BASIL-1 and BEST-CLI, which both suggested that a surgical approach for chronic limb-threatening ischemia may be most appropriate.
The BASIL-2 study was published online in The Lancet.
The authors explained that chronic limb-threatening ischemia, previously known as critical limb ischemia and severe ischemia of the leg, is the most severe form of peripheral arterial disease caused by atherosclerosis. Patients present with ischemic rest pain and tissue loss (ulceration, gangrene, or both) that usually affects the foot.
Mainly because of tobacco smoking and the growing prevalence of type 2 diabetes, chronic limb-threatening ischemia represents a growing burden on health care and social care services around the world.
Unless the blood supply to the affected limb is restored, patients with chronic limb-threatening ischemia are at high risk for amputation or death. Although it is universally agreed that – in addition to best medical therapy – virtually all patients with chronic limb-threatening ischemia should at least be considered for revascularization, there is continuing debate as to whether conducting vein bypass surgery, preferably using a vein taken from the patient’s own leg, or endovascular treatment (balloon angioplasty with or without stents) is preferable.
“BASIL-2 is the only randomized trial to specifically compare a vein bypass first with best endovascular treatment first revascularisation strategy in patients with chronic limb-threatening ischemia who required an infrapopliteal (with or without an additional more proximal infrainguinal) revascularization procedure to restore limb perfusion,” the authors noted.
For the trial, which was conducted at 41 vascular surgery units in the United Kingdom, Sweden, and Denmark, 345 patients with chronic limb-threatening ischemia who required an infrapopliteal revascularization procedure to restore limb perfusion were randomly assigned to receive either vein bypass or best endovascular treatment as their first revascularization procedure.
Most vein bypasses used the great saphenous vein and originated from the common or superficial femoral arteries. Most endovascular interventions comprised plain balloon angioplasty with selective use of plain or drug-eluting stents. Participants were followed up for a minimum of 2 years.
The primary outcome was amputation-free survival, defined as time to first major (above the ankle) amputation or death from any cause measured in the intention-to-treat population.
Results showed that major amputation or death occurred in 63% of patients in the vein bypass group and in 53% of those in the best endovascular treatment group (adjusted hazard ratio, 1.35; P = .037).
The results were driven by a higher death rate in the vein bypass group (53% vs. 45%; aHR, 1.37).
In both groups, the most common causes of morbidity and death, including death occurring within 30 days of first revascularization, were cardiovascular and respiratory events.
The authors noted that outcomes for the patients in the BASIL-2 trial were poor (median amputation-free survival was 3.8 years, and half the patients died within 5 years).
They pointed out that severe, multilevel atherosclerotic disease that causes chronic limb-threatening ischemia develops over many years, but at baseline in this study, around 20% of patients said they were still smoking, and around 70% of patients had diabetes, of whom around 50% required insulin. In addition, around 90% of the participants often had quite extensive tissue loss.
“These baseline data suggest that there might still be missed opportunities in public health and primary care to prevent chronic limb-threatening ischemia through medical therapy and lifestyle interventions and missed opportunities to refer patients to secondary care earlier once chronic limb-threatening ischemia begins to develop,” they suggested.
“Better prevention and timely referral are important: the BASIL-2 trial shows that, by the time patients present to vascular and endovascular surgeons and interventional radiologists with established chronic limb-threatening ischemia, their prognosis is often poor regardless of what form of revascularization they are offered,” they added.
Conflicting results
In an accompanying comment, Ankur Kalra, MD, Franciscan Health, Lafayette, Ind., and Ashish Kumar, MD, Cleveland Clinic Akron (Ohio) General, noted that atherosclerotic lower-extremity peripheral artery disease affects more than 230 million people worldwide, and prevalence is increasing. Chronic limb-threatening ischemia is a severe form of peripheral artery disease that affects 11% of patients with peripheral artery disease and is associated with significant cardiovascular morbidity and death.
Furthermore, amputation rates of 10%-40% during a 6-month follow-up of patients with chronic limb-threatening ischemia who were unable to undergo revascularization have been reported, highlighting the severity of atherosclerotic burden and the need for improved treatment strategies.
Dr. Kalra and Dr. Kumar pointed out that two previous randomized clinical trials compared surgical vein graft bypass with endovascular treatment for patients with chronic limb-threatening ischemia – the BASIL-1 trial, and the BEST-CLI trial.
In the BASIL-1 trial, vein bypass was associated with improved overall survival and amputation-free survival for patients who survived at least 2 years. The BEST-CLI trial also reported a lower risk of a composite of major adverse limb events or death among patients undergoing a surgery-first strategy, compared with endovascular therapy, mostly in patients with suitable single segment of great saphenous vein.
Dr. Kalra and Dr. Kumar said the findings of the BASIL-2 trial should be put in context with these previous studies, which report a positive or equivocal effect of surgery. The results of the BEST-CLI trial were driven by fewer major reinterventions and above-ankle amputations in the surgical group, whereas the results of the BASIL-2 trial were driven by fewer deaths in the best endovascular treatment group, “which potentially points towards a difference in the characteristics of the patients randomly assigned in the two trials.”
They concluded: “Considering the results of the BASIL-2 trial and the BEST-CLI trial, choice of intervention should be based on shared decision making between interventional cardiology, vascular surgery, and the patient, until more evidence is accrued.”
The BASIL-2 trial was funded by the U.K. National Institute of Health Research.
A version of this article first appeared on Medscape.com.
in a new randomized trial.
In the Bypass Versus Angioplasty in Severe Ischaemia of the Leg (BASIL-2) trial, patients who received vein bypass as the first approach were more likely to require a major amputation or to die during follow-up than patients who were randomly assigned to the endovascular approach as first strategy.
“Our findings suggest that a best endovascular treatment first revascularization strategy is associated with a better amputation-free survival. This is mainly because the best endovascular treatment first revascularization strategy resulted in fewer deaths. Limb-related outcomes were similar between groups,” the authors stated.
“The BASIL-2 trial has produced a statistically robust and clinically meaningful result that is likely to have an influence on the management of chronic limb-threatening ischemia worldwide,” added the study’s chief investigator, Andrew Bradbury, MD, professor of vascular surgery at the University of Birmingham (England).
However, the results of the BASIL-2 trial conflict with those from two previous studies – BASIL-1 and BEST-CLI, which both suggested that a surgical approach for chronic limb-threatening ischemia may be most appropriate.
The BASIL-2 study was published online in The Lancet.
The authors explained that chronic limb-threatening ischemia, previously known as critical limb ischemia and severe ischemia of the leg, is the most severe form of peripheral arterial disease caused by atherosclerosis. Patients present with ischemic rest pain and tissue loss (ulceration, gangrene, or both) that usually affects the foot.
Mainly because of tobacco smoking and the growing prevalence of type 2 diabetes, chronic limb-threatening ischemia represents a growing burden on health care and social care services around the world.
Unless the blood supply to the affected limb is restored, patients with chronic limb-threatening ischemia are at high risk for amputation or death. Although it is universally agreed that – in addition to best medical therapy – virtually all patients with chronic limb-threatening ischemia should at least be considered for revascularization, there is continuing debate as to whether conducting vein bypass surgery, preferably using a vein taken from the patient’s own leg, or endovascular treatment (balloon angioplasty with or without stents) is preferable.
“BASIL-2 is the only randomized trial to specifically compare a vein bypass first with best endovascular treatment first revascularisation strategy in patients with chronic limb-threatening ischemia who required an infrapopliteal (with or without an additional more proximal infrainguinal) revascularization procedure to restore limb perfusion,” the authors noted.
For the trial, which was conducted at 41 vascular surgery units in the United Kingdom, Sweden, and Denmark, 345 patients with chronic limb-threatening ischemia who required an infrapopliteal revascularization procedure to restore limb perfusion were randomly assigned to receive either vein bypass or best endovascular treatment as their first revascularization procedure.
Most vein bypasses used the great saphenous vein and originated from the common or superficial femoral arteries. Most endovascular interventions comprised plain balloon angioplasty with selective use of plain or drug-eluting stents. Participants were followed up for a minimum of 2 years.
The primary outcome was amputation-free survival, defined as time to first major (above the ankle) amputation or death from any cause measured in the intention-to-treat population.
Results showed that major amputation or death occurred in 63% of patients in the vein bypass group and in 53% of those in the best endovascular treatment group (adjusted hazard ratio, 1.35; P = .037).
The results were driven by a higher death rate in the vein bypass group (53% vs. 45%; aHR, 1.37).
In both groups, the most common causes of morbidity and death, including death occurring within 30 days of first revascularization, were cardiovascular and respiratory events.
The authors noted that outcomes for the patients in the BASIL-2 trial were poor (median amputation-free survival was 3.8 years, and half the patients died within 5 years).
They pointed out that severe, multilevel atherosclerotic disease that causes chronic limb-threatening ischemia develops over many years, but at baseline in this study, around 20% of patients said they were still smoking, and around 70% of patients had diabetes, of whom around 50% required insulin. In addition, around 90% of the participants often had quite extensive tissue loss.
“These baseline data suggest that there might still be missed opportunities in public health and primary care to prevent chronic limb-threatening ischemia through medical therapy and lifestyle interventions and missed opportunities to refer patients to secondary care earlier once chronic limb-threatening ischemia begins to develop,” they suggested.
“Better prevention and timely referral are important: the BASIL-2 trial shows that, by the time patients present to vascular and endovascular surgeons and interventional radiologists with established chronic limb-threatening ischemia, their prognosis is often poor regardless of what form of revascularization they are offered,” they added.
Conflicting results
In an accompanying comment, Ankur Kalra, MD, Franciscan Health, Lafayette, Ind., and Ashish Kumar, MD, Cleveland Clinic Akron (Ohio) General, noted that atherosclerotic lower-extremity peripheral artery disease affects more than 230 million people worldwide, and prevalence is increasing. Chronic limb-threatening ischemia is a severe form of peripheral artery disease that affects 11% of patients with peripheral artery disease and is associated with significant cardiovascular morbidity and death.
Furthermore, amputation rates of 10%-40% during a 6-month follow-up of patients with chronic limb-threatening ischemia who were unable to undergo revascularization have been reported, highlighting the severity of atherosclerotic burden and the need for improved treatment strategies.
Dr. Kalra and Dr. Kumar pointed out that two previous randomized clinical trials compared surgical vein graft bypass with endovascular treatment for patients with chronic limb-threatening ischemia – the BASIL-1 trial, and the BEST-CLI trial.
In the BASIL-1 trial, vein bypass was associated with improved overall survival and amputation-free survival for patients who survived at least 2 years. The BEST-CLI trial also reported a lower risk of a composite of major adverse limb events or death among patients undergoing a surgery-first strategy, compared with endovascular therapy, mostly in patients with suitable single segment of great saphenous vein.
Dr. Kalra and Dr. Kumar said the findings of the BASIL-2 trial should be put in context with these previous studies, which report a positive or equivocal effect of surgery. The results of the BEST-CLI trial were driven by fewer major reinterventions and above-ankle amputations in the surgical group, whereas the results of the BASIL-2 trial were driven by fewer deaths in the best endovascular treatment group, “which potentially points towards a difference in the characteristics of the patients randomly assigned in the two trials.”
They concluded: “Considering the results of the BASIL-2 trial and the BEST-CLI trial, choice of intervention should be based on shared decision making between interventional cardiology, vascular surgery, and the patient, until more evidence is accrued.”
The BASIL-2 trial was funded by the U.K. National Institute of Health Research.
A version of this article first appeared on Medscape.com.
in a new randomized trial.
In the Bypass Versus Angioplasty in Severe Ischaemia of the Leg (BASIL-2) trial, patients who received vein bypass as the first approach were more likely to require a major amputation or to die during follow-up than patients who were randomly assigned to the endovascular approach as first strategy.
“Our findings suggest that a best endovascular treatment first revascularization strategy is associated with a better amputation-free survival. This is mainly because the best endovascular treatment first revascularization strategy resulted in fewer deaths. Limb-related outcomes were similar between groups,” the authors stated.
“The BASIL-2 trial has produced a statistically robust and clinically meaningful result that is likely to have an influence on the management of chronic limb-threatening ischemia worldwide,” added the study’s chief investigator, Andrew Bradbury, MD, professor of vascular surgery at the University of Birmingham (England).
However, the results of the BASIL-2 trial conflict with those from two previous studies – BASIL-1 and BEST-CLI, which both suggested that a surgical approach for chronic limb-threatening ischemia may be most appropriate.
The BASIL-2 study was published online in The Lancet.
The authors explained that chronic limb-threatening ischemia, previously known as critical limb ischemia and severe ischemia of the leg, is the most severe form of peripheral arterial disease caused by atherosclerosis. Patients present with ischemic rest pain and tissue loss (ulceration, gangrene, or both) that usually affects the foot.
Mainly because of tobacco smoking and the growing prevalence of type 2 diabetes, chronic limb-threatening ischemia represents a growing burden on health care and social care services around the world.
Unless the blood supply to the affected limb is restored, patients with chronic limb-threatening ischemia are at high risk for amputation or death. Although it is universally agreed that – in addition to best medical therapy – virtually all patients with chronic limb-threatening ischemia should at least be considered for revascularization, there is continuing debate as to whether conducting vein bypass surgery, preferably using a vein taken from the patient’s own leg, or endovascular treatment (balloon angioplasty with or without stents) is preferable.
“BASIL-2 is the only randomized trial to specifically compare a vein bypass first with best endovascular treatment first revascularisation strategy in patients with chronic limb-threatening ischemia who required an infrapopliteal (with or without an additional more proximal infrainguinal) revascularization procedure to restore limb perfusion,” the authors noted.
For the trial, which was conducted at 41 vascular surgery units in the United Kingdom, Sweden, and Denmark, 345 patients with chronic limb-threatening ischemia who required an infrapopliteal revascularization procedure to restore limb perfusion were randomly assigned to receive either vein bypass or best endovascular treatment as their first revascularization procedure.
Most vein bypasses used the great saphenous vein and originated from the common or superficial femoral arteries. Most endovascular interventions comprised plain balloon angioplasty with selective use of plain or drug-eluting stents. Participants were followed up for a minimum of 2 years.
The primary outcome was amputation-free survival, defined as time to first major (above the ankle) amputation or death from any cause measured in the intention-to-treat population.
Results showed that major amputation or death occurred in 63% of patients in the vein bypass group and in 53% of those in the best endovascular treatment group (adjusted hazard ratio, 1.35; P = .037).
The results were driven by a higher death rate in the vein bypass group (53% vs. 45%; aHR, 1.37).
In both groups, the most common causes of morbidity and death, including death occurring within 30 days of first revascularization, were cardiovascular and respiratory events.
The authors noted that outcomes for the patients in the BASIL-2 trial were poor (median amputation-free survival was 3.8 years, and half the patients died within 5 years).
They pointed out that severe, multilevel atherosclerotic disease that causes chronic limb-threatening ischemia develops over many years, but at baseline in this study, around 20% of patients said they were still smoking, and around 70% of patients had diabetes, of whom around 50% required insulin. In addition, around 90% of the participants often had quite extensive tissue loss.
“These baseline data suggest that there might still be missed opportunities in public health and primary care to prevent chronic limb-threatening ischemia through medical therapy and lifestyle interventions and missed opportunities to refer patients to secondary care earlier once chronic limb-threatening ischemia begins to develop,” they suggested.
“Better prevention and timely referral are important: the BASIL-2 trial shows that, by the time patients present to vascular and endovascular surgeons and interventional radiologists with established chronic limb-threatening ischemia, their prognosis is often poor regardless of what form of revascularization they are offered,” they added.
Conflicting results
In an accompanying comment, Ankur Kalra, MD, Franciscan Health, Lafayette, Ind., and Ashish Kumar, MD, Cleveland Clinic Akron (Ohio) General, noted that atherosclerotic lower-extremity peripheral artery disease affects more than 230 million people worldwide, and prevalence is increasing. Chronic limb-threatening ischemia is a severe form of peripheral artery disease that affects 11% of patients with peripheral artery disease and is associated with significant cardiovascular morbidity and death.
Furthermore, amputation rates of 10%-40% during a 6-month follow-up of patients with chronic limb-threatening ischemia who were unable to undergo revascularization have been reported, highlighting the severity of atherosclerotic burden and the need for improved treatment strategies.
Dr. Kalra and Dr. Kumar pointed out that two previous randomized clinical trials compared surgical vein graft bypass with endovascular treatment for patients with chronic limb-threatening ischemia – the BASIL-1 trial, and the BEST-CLI trial.
In the BASIL-1 trial, vein bypass was associated with improved overall survival and amputation-free survival for patients who survived at least 2 years. The BEST-CLI trial also reported a lower risk of a composite of major adverse limb events or death among patients undergoing a surgery-first strategy, compared with endovascular therapy, mostly in patients with suitable single segment of great saphenous vein.
Dr. Kalra and Dr. Kumar said the findings of the BASIL-2 trial should be put in context with these previous studies, which report a positive or equivocal effect of surgery. The results of the BEST-CLI trial were driven by fewer major reinterventions and above-ankle amputations in the surgical group, whereas the results of the BASIL-2 trial were driven by fewer deaths in the best endovascular treatment group, “which potentially points towards a difference in the characteristics of the patients randomly assigned in the two trials.”
They concluded: “Considering the results of the BASIL-2 trial and the BEST-CLI trial, choice of intervention should be based on shared decision making between interventional cardiology, vascular surgery, and the patient, until more evidence is accrued.”
The BASIL-2 trial was funded by the U.K. National Institute of Health Research.
A version of this article first appeared on Medscape.com.
FROM THE LANCET
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
Medical students gain momentum in effort to ban legacy admissions
, which they say offer preferential treatment to applicants based on their association with donors or alumni.
While an estimated 25% of public colleges and universities still use legacy admissions, a growing list of top medical schools have moved away from the practice over the last decade, including Johns Hopkins University, Baltimore, and Tufts University, Medford, Mass.
Legacy admissions contradict schools’ more inclusive policies, Senila Yasmin, MPH, a second-year medical student at Tufts University, said in an interview. While Tufts maintains legacy admissions for its undergraduate applicants, the medical school stopped the practice in 2021, said Ms. Yasmin, a member of a student group that lobbied against the school’s legacy preferences.
Describing herself as a low-income, first-generation Muslim-Pakistani American, Ms. Yasmin wants to use her experience at Tufts to improve accessibility for students like herself.
As a member of the American Medical Association (AMA) Medical Student Section, she coauthored a resolution stating that legacy admissions go against the AMA’s strategic plan to advance racial justice and health equity. The Student Section passed the resolution in November, and in June, the AMA House of Delegates will vote on whether to adopt the policy.
Along with a Supreme Court decision that could strike down race-conscious college admissions, an AMA policy could convince medical schools to rethink legacy admissions and how to maintain diverse student bodies. In June, the court is expected to issue a decision in the Students for Fair Admissions lawsuit against Harvard University, Cambridge, Mass., and the University of North Carolina, Chapel Hill, which alleges that considering race in holistic admissions constitutes racial discrimination and violates the Equal Protection Clause.
Opponents of legacy admissions, like Ms. Yasmin, say it penalizes students from racial minorities and lower socioeconomic backgrounds, hampering a fair and equitable admissions process that attracts diverse medical school admissions.
Diversity of medical applicants
Diversity in medical schools continued to increase last year with more Black, Hispanic, and female students applying and enrolling, according to a recent report by the Association of American Medical Colleges (AAMC). However, universities often include nonacademic criteria in their admission assessments to improve educational access for underrepresented minorities.
Medical schools carefully consider each applicant’s background “to yield a diverse class of students,” Geoffrey Young, PhD, AAMC’s senior director of transforming the health care workforce, told this news organization.
Some schools, such as Morehouse School of Medicine, Atlanta, the University of Virginia School of Medicine, Charlottesville, and the University of Arizona College of Medicine, Tucson, perform a thorough review of candidates while offering admissions practices designed specifically for legacy applicants. The schools assert that legacy designation doesn’t factor into the student’s likelihood of acceptance.
The arrangement may show that schools want to commit to equity and fairness but have trouble moving away from entrenched traditions, two professors from Penn State College of Medicine, Hershey, Pa., who sit on separate medical admissions subcommittees, wrote last year in Bioethics Today.
Legislation may hasten legacies’ end
In December, Ms. Yasmin and a group of Massachusetts Medical Society student-members presented another resolution to the state medical society, which adopted it.
The society’s new policy opposes the use of legacy status in medical school admissions and supports mechanisms to eliminate its inclusion from the application process, Theodore Calianos II, MD, FACS, president of the Massachusetts Medical Society, said in an interview.
“Legacy preferences limit racial and socioeconomic diversity on campuses, so we asked, ‘What can we do so that everyone has equal access to medical education?’ It is exciting to see the students and young physicians – the future of medicine – become involved in policymaking.”
Proposed laws may also hasten the end of legacy admissions. Last year, the U.S. Senate began considering a bill prohibiting colleges receiving federal financial aid from giving preferential treatment to students based on their relations to donors or alumni. However, the bill allows the Department of Education to make exceptions for institutions serving historically underrepresented groups.
The New York State Senate and the New York State Assembly also are reviewing bills that ban legacy and early admissions policies at public and private universities. Connecticut announced similar legislation last year. Massachusetts legislators are considering two bills: one that would ban the practice at the state’s public universities and another that would require all schools using legacy status to pay a “public service fee” equal to a percentage of its endowment. Colleges with endowment assets exceeding $2 billion must pay at least $2 million, according to the bill’s text.
At schools like Harvard, whose endowment surpasses $50 billion, the option to pay the penalty will make the law moot, Michael Walls, DO, MPH, president of the American Medical Student Association (AMSA), said in an interview. “Smaller schools wouldn’t be able to afford the fine and are less likely to be doing [legacy admissions] anyway,” he said. “The schools that want to continue doing it could just pay the fine.”
Dr. Walls said AMSA supports race-conscious admissions processes and anything that increases fairness for medical school applicants. “Whatever [fair] means is up for interpretation, but it would be great to eliminate legacy admissions,” he said.
A version of this article originally appeared on Medscape.com.
, which they say offer preferential treatment to applicants based on their association with donors or alumni.
While an estimated 25% of public colleges and universities still use legacy admissions, a growing list of top medical schools have moved away from the practice over the last decade, including Johns Hopkins University, Baltimore, and Tufts University, Medford, Mass.
Legacy admissions contradict schools’ more inclusive policies, Senila Yasmin, MPH, a second-year medical student at Tufts University, said in an interview. While Tufts maintains legacy admissions for its undergraduate applicants, the medical school stopped the practice in 2021, said Ms. Yasmin, a member of a student group that lobbied against the school’s legacy preferences.
Describing herself as a low-income, first-generation Muslim-Pakistani American, Ms. Yasmin wants to use her experience at Tufts to improve accessibility for students like herself.
As a member of the American Medical Association (AMA) Medical Student Section, she coauthored a resolution stating that legacy admissions go against the AMA’s strategic plan to advance racial justice and health equity. The Student Section passed the resolution in November, and in June, the AMA House of Delegates will vote on whether to adopt the policy.
Along with a Supreme Court decision that could strike down race-conscious college admissions, an AMA policy could convince medical schools to rethink legacy admissions and how to maintain diverse student bodies. In June, the court is expected to issue a decision in the Students for Fair Admissions lawsuit against Harvard University, Cambridge, Mass., and the University of North Carolina, Chapel Hill, which alleges that considering race in holistic admissions constitutes racial discrimination and violates the Equal Protection Clause.
Opponents of legacy admissions, like Ms. Yasmin, say it penalizes students from racial minorities and lower socioeconomic backgrounds, hampering a fair and equitable admissions process that attracts diverse medical school admissions.
Diversity of medical applicants
Diversity in medical schools continued to increase last year with more Black, Hispanic, and female students applying and enrolling, according to a recent report by the Association of American Medical Colleges (AAMC). However, universities often include nonacademic criteria in their admission assessments to improve educational access for underrepresented minorities.
Medical schools carefully consider each applicant’s background “to yield a diverse class of students,” Geoffrey Young, PhD, AAMC’s senior director of transforming the health care workforce, told this news organization.
Some schools, such as Morehouse School of Medicine, Atlanta, the University of Virginia School of Medicine, Charlottesville, and the University of Arizona College of Medicine, Tucson, perform a thorough review of candidates while offering admissions practices designed specifically for legacy applicants. The schools assert that legacy designation doesn’t factor into the student’s likelihood of acceptance.
The arrangement may show that schools want to commit to equity and fairness but have trouble moving away from entrenched traditions, two professors from Penn State College of Medicine, Hershey, Pa., who sit on separate medical admissions subcommittees, wrote last year in Bioethics Today.
Legislation may hasten legacies’ end
In December, Ms. Yasmin and a group of Massachusetts Medical Society student-members presented another resolution to the state medical society, which adopted it.
The society’s new policy opposes the use of legacy status in medical school admissions and supports mechanisms to eliminate its inclusion from the application process, Theodore Calianos II, MD, FACS, president of the Massachusetts Medical Society, said in an interview.
“Legacy preferences limit racial and socioeconomic diversity on campuses, so we asked, ‘What can we do so that everyone has equal access to medical education?’ It is exciting to see the students and young physicians – the future of medicine – become involved in policymaking.”
Proposed laws may also hasten the end of legacy admissions. Last year, the U.S. Senate began considering a bill prohibiting colleges receiving federal financial aid from giving preferential treatment to students based on their relations to donors or alumni. However, the bill allows the Department of Education to make exceptions for institutions serving historically underrepresented groups.
The New York State Senate and the New York State Assembly also are reviewing bills that ban legacy and early admissions policies at public and private universities. Connecticut announced similar legislation last year. Massachusetts legislators are considering two bills: one that would ban the practice at the state’s public universities and another that would require all schools using legacy status to pay a “public service fee” equal to a percentage of its endowment. Colleges with endowment assets exceeding $2 billion must pay at least $2 million, according to the bill’s text.
At schools like Harvard, whose endowment surpasses $50 billion, the option to pay the penalty will make the law moot, Michael Walls, DO, MPH, president of the American Medical Student Association (AMSA), said in an interview. “Smaller schools wouldn’t be able to afford the fine and are less likely to be doing [legacy admissions] anyway,” he said. “The schools that want to continue doing it could just pay the fine.”
Dr. Walls said AMSA supports race-conscious admissions processes and anything that increases fairness for medical school applicants. “Whatever [fair] means is up for interpretation, but it would be great to eliminate legacy admissions,” he said.
A version of this article originally appeared on Medscape.com.
, which they say offer preferential treatment to applicants based on their association with donors or alumni.
While an estimated 25% of public colleges and universities still use legacy admissions, a growing list of top medical schools have moved away from the practice over the last decade, including Johns Hopkins University, Baltimore, and Tufts University, Medford, Mass.
Legacy admissions contradict schools’ more inclusive policies, Senila Yasmin, MPH, a second-year medical student at Tufts University, said in an interview. While Tufts maintains legacy admissions for its undergraduate applicants, the medical school stopped the practice in 2021, said Ms. Yasmin, a member of a student group that lobbied against the school’s legacy preferences.
Describing herself as a low-income, first-generation Muslim-Pakistani American, Ms. Yasmin wants to use her experience at Tufts to improve accessibility for students like herself.
As a member of the American Medical Association (AMA) Medical Student Section, she coauthored a resolution stating that legacy admissions go against the AMA’s strategic plan to advance racial justice and health equity. The Student Section passed the resolution in November, and in June, the AMA House of Delegates will vote on whether to adopt the policy.
Along with a Supreme Court decision that could strike down race-conscious college admissions, an AMA policy could convince medical schools to rethink legacy admissions and how to maintain diverse student bodies. In June, the court is expected to issue a decision in the Students for Fair Admissions lawsuit against Harvard University, Cambridge, Mass., and the University of North Carolina, Chapel Hill, which alleges that considering race in holistic admissions constitutes racial discrimination and violates the Equal Protection Clause.
Opponents of legacy admissions, like Ms. Yasmin, say it penalizes students from racial minorities and lower socioeconomic backgrounds, hampering a fair and equitable admissions process that attracts diverse medical school admissions.
Diversity of medical applicants
Diversity in medical schools continued to increase last year with more Black, Hispanic, and female students applying and enrolling, according to a recent report by the Association of American Medical Colleges (AAMC). However, universities often include nonacademic criteria in their admission assessments to improve educational access for underrepresented minorities.
Medical schools carefully consider each applicant’s background “to yield a diverse class of students,” Geoffrey Young, PhD, AAMC’s senior director of transforming the health care workforce, told this news organization.
Some schools, such as Morehouse School of Medicine, Atlanta, the University of Virginia School of Medicine, Charlottesville, and the University of Arizona College of Medicine, Tucson, perform a thorough review of candidates while offering admissions practices designed specifically for legacy applicants. The schools assert that legacy designation doesn’t factor into the student’s likelihood of acceptance.
The arrangement may show that schools want to commit to equity and fairness but have trouble moving away from entrenched traditions, two professors from Penn State College of Medicine, Hershey, Pa., who sit on separate medical admissions subcommittees, wrote last year in Bioethics Today.
Legislation may hasten legacies’ end
In December, Ms. Yasmin and a group of Massachusetts Medical Society student-members presented another resolution to the state medical society, which adopted it.
The society’s new policy opposes the use of legacy status in medical school admissions and supports mechanisms to eliminate its inclusion from the application process, Theodore Calianos II, MD, FACS, president of the Massachusetts Medical Society, said in an interview.
“Legacy preferences limit racial and socioeconomic diversity on campuses, so we asked, ‘What can we do so that everyone has equal access to medical education?’ It is exciting to see the students and young physicians – the future of medicine – become involved in policymaking.”
Proposed laws may also hasten the end of legacy admissions. Last year, the U.S. Senate began considering a bill prohibiting colleges receiving federal financial aid from giving preferential treatment to students based on their relations to donors or alumni. However, the bill allows the Department of Education to make exceptions for institutions serving historically underrepresented groups.
The New York State Senate and the New York State Assembly also are reviewing bills that ban legacy and early admissions policies at public and private universities. Connecticut announced similar legislation last year. Massachusetts legislators are considering two bills: one that would ban the practice at the state’s public universities and another that would require all schools using legacy status to pay a “public service fee” equal to a percentage of its endowment. Colleges with endowment assets exceeding $2 billion must pay at least $2 million, according to the bill’s text.
At schools like Harvard, whose endowment surpasses $50 billion, the option to pay the penalty will make the law moot, Michael Walls, DO, MPH, president of the American Medical Student Association (AMSA), said in an interview. “Smaller schools wouldn’t be able to afford the fine and are less likely to be doing [legacy admissions] anyway,” he said. “The schools that want to continue doing it could just pay the fine.”
Dr. Walls said AMSA supports race-conscious admissions processes and anything that increases fairness for medical school applicants. “Whatever [fair] means is up for interpretation, but it would be great to eliminate legacy admissions,” he said.
A version of this article originally appeared on Medscape.com.
Five ways docs may qualify for discounts on medical malpractice premiums
Getting a better deal might simply mean taking advantage of incentives and discounts your insurer may already offer. These include claims-free, new-to-practice, and working part-time discounts.
However, if you decide to shop around, keep in mind that discounts are just one factor that can affect your premium price – insurers look at your specialty, location, and claims history.
One of the most common ways physicians can earn discounts is by participating in risk management programs. With this type of program, physicians evaluate elements of their practice and documentation practices and identify areas that might leave them at risk for a lawsuit. While they save money, physician risk management programs also are designed to reduce malpractice claims, which ultimately minimizes the potential for bigger financial losses, insurance experts say.
“It’s a win-win situation when liability insurers and physicians work together to minimize risk, and it’s a win for patients,” said Gary Price, MD, president of The Physicians Foundation.
Doctors in private practice or employed by small hospitals that are not self-insured can qualify for these discounts, said David Zetter, president of Zetter HealthCare Management Consultants.
“I do a lot of work with medical malpractice companies trying to find clients policies. All the carriers are transparent about what physicians have to do to lower their premiums. Physicians can receive the discounts if they follow through and meet the insurer’s requirements,” said Mr. Zetter.
State insurance departments regulate medical malpractice insurance, including the premium credits insurers offer. Most states cap discounts at 25%, but some go as high as 70%, according to The Doctors Company, a national physician-owned medical malpractice insurer.
Insurers typically offer doctors several ways to earn discounts. The size of the discount also can depend on whether a doctor is new to a practice, remains claims free, or takes risk management courses.
In addition to the premium discount, some online risk management classes and webinars are eligible for CME credits.
“The credits can add up and they can be used for recertification or relicensure,” said Susan Boisvert, senior patient safety risk manager at The Doctors Company.
Here are five ways you may qualify for discounts with your insurer.
1. Make use of discounts available to new doctors
Doctors can earn hefty discounts on their premiums when they are no longer interns or residents and start practicing medicine. The Doctors Company usually gives a 50% discount on member premiums the first year they’re in practice and a 25% discount credit in their second year. The discounts end after that.
Other insurance carriers offer similar discounts to doctors starting to practice medicine. The deepest one is offered in the first year (at least 50%) and a smaller one (20%-25%) the second year, according to medical malpractice brokers.
“The new-to-practice discount is based solely on when the physician left their formal training to begin their practice for the first time; it is not based on claim-free history,” explained Mr. Zetter.
This is a very common discount used by different insurer carriers, said Dr. Price. “New physicians don’t have the same amount of risk of a lawsuit when they’re starting out. It’s unlikely they will have a claim and most liability actions have a 2-year time limit from the date of injury to be filed.”
2. Take advantage of being claims free
If you’ve been claims free for at least a few years, you may be eligible for a large discount.
“Doctors without claims are a better risk. Once a doctor has one claim, they’re likely to have a second, which the research shows,” said Mr. Zetter.
The most common credit The Doctors Company offers is 3 years of being claim free – this earns doctors up to 25%, he said. Mr. Zetter explained that the criteria and size of The Doctors Company credit may depend on the state where physicians practice.
“We allowed insurance carriers that we acquired to continue with their own claim-free discount program such as Florida’s First Professionals Insurance Company we acquired in 2011,” he said.
Doctors with other medical malpractice insurers may also be eligible for a credit up to 25%. In some instances, they may have to be claims free for 5 or 10 years, say insurance experts.
It pays to shop around before purchasing insurance.
3. If you work part time, make sure your premium reflects that
Physicians who see patients part time can receive up to a 75% discount on their medical liability insurance premiums.
The discounts are based on the hours the physician works per week. The fewer hours worked, the larger the discount. This type of discount does not vary by specialty.
According to The Doctors Company, working 10 hours or less per week may entitle doctors to a 75% discount; working 11-20 hours per week may entitle them to a 50% discount, and working 21-30 hours per week may entitle them to a 25% discount. If you are in this situation, it pays to ask your insurer if there is a discount available to you.
4. Look into your professional medical society insurance company
“I would look at your state medical association [or] state specialty society and talk to your colleagues to learn what premiums they’re paying and about any discounts they’re getting,” advised Mr. Zetter.
Some state medical societies have formed their own liability companies and offer lower premiums to their members because “they’re organized and managed by doctors, which makes their premiums more competitive,” Dr. Price said.
Other state medical societies endorse specific insurance carriers and offer their members a 5% discount for enrolling with them.
5. Enroll in a risk management program
Most insurers offer online educational activities designed to improve patient safety and reduce the risk of a lawsuit. Physicians may be eligible for both premium discounts and CME credits.
Medical Liability Mutual Insurance Company, owned by Berkshire Hathaway, operates in New York and offers physicians a premium discount of up to 5%, CME credit, and maintenance of certification credit for successfully completing its risk management program every other year.
ProAssurance members nationwide can earn 5% in premium discounts if they complete a 2-hour video series called “Back to Basics: Loss Prevention and Navigating Everyday Risks: Using Data to Drive Change.”
They can earn one credit for completing each webinar on topics such as “Medication Management: Minimizing Errors and Improving Safety” and “Opioid Prescribing: Keeping Patients Safe.”
MagMutual offers its insured physicians 1 CME credit for completing their specialty’s risk assessment and courses, which may be applied toward their premium discounts.
The Doctors Company offers its members a 5% premium discount if they complete 4 CME credits. One of its most popular courses is “How To Get Rid of a Difficult Patient.”
“Busy residents like the shorter case studies worth one-quarter credit that they can complete in 15 minutes,” said Ms. Boisvert.
“This is a good bargain from the physician’s standpoint and the fact that risk management education is offered online makes it a lot easier than going to a seminar in person,” said Dr. Price.
A version of this article first appeared on Medscape.com.
Getting a better deal might simply mean taking advantage of incentives and discounts your insurer may already offer. These include claims-free, new-to-practice, and working part-time discounts.
However, if you decide to shop around, keep in mind that discounts are just one factor that can affect your premium price – insurers look at your specialty, location, and claims history.
One of the most common ways physicians can earn discounts is by participating in risk management programs. With this type of program, physicians evaluate elements of their practice and documentation practices and identify areas that might leave them at risk for a lawsuit. While they save money, physician risk management programs also are designed to reduce malpractice claims, which ultimately minimizes the potential for bigger financial losses, insurance experts say.
“It’s a win-win situation when liability insurers and physicians work together to minimize risk, and it’s a win for patients,” said Gary Price, MD, president of The Physicians Foundation.
Doctors in private practice or employed by small hospitals that are not self-insured can qualify for these discounts, said David Zetter, president of Zetter HealthCare Management Consultants.
“I do a lot of work with medical malpractice companies trying to find clients policies. All the carriers are transparent about what physicians have to do to lower their premiums. Physicians can receive the discounts if they follow through and meet the insurer’s requirements,” said Mr. Zetter.
State insurance departments regulate medical malpractice insurance, including the premium credits insurers offer. Most states cap discounts at 25%, but some go as high as 70%, according to The Doctors Company, a national physician-owned medical malpractice insurer.
Insurers typically offer doctors several ways to earn discounts. The size of the discount also can depend on whether a doctor is new to a practice, remains claims free, or takes risk management courses.
In addition to the premium discount, some online risk management classes and webinars are eligible for CME credits.
“The credits can add up and they can be used for recertification or relicensure,” said Susan Boisvert, senior patient safety risk manager at The Doctors Company.
Here are five ways you may qualify for discounts with your insurer.
1. Make use of discounts available to new doctors
Doctors can earn hefty discounts on their premiums when they are no longer interns or residents and start practicing medicine. The Doctors Company usually gives a 50% discount on member premiums the first year they’re in practice and a 25% discount credit in their second year. The discounts end after that.
Other insurance carriers offer similar discounts to doctors starting to practice medicine. The deepest one is offered in the first year (at least 50%) and a smaller one (20%-25%) the second year, according to medical malpractice brokers.
“The new-to-practice discount is based solely on when the physician left their formal training to begin their practice for the first time; it is not based on claim-free history,” explained Mr. Zetter.
This is a very common discount used by different insurer carriers, said Dr. Price. “New physicians don’t have the same amount of risk of a lawsuit when they’re starting out. It’s unlikely they will have a claim and most liability actions have a 2-year time limit from the date of injury to be filed.”
2. Take advantage of being claims free
If you’ve been claims free for at least a few years, you may be eligible for a large discount.
“Doctors without claims are a better risk. Once a doctor has one claim, they’re likely to have a second, which the research shows,” said Mr. Zetter.
The most common credit The Doctors Company offers is 3 years of being claim free – this earns doctors up to 25%, he said. Mr. Zetter explained that the criteria and size of The Doctors Company credit may depend on the state where physicians practice.
“We allowed insurance carriers that we acquired to continue with their own claim-free discount program such as Florida’s First Professionals Insurance Company we acquired in 2011,” he said.
Doctors with other medical malpractice insurers may also be eligible for a credit up to 25%. In some instances, they may have to be claims free for 5 or 10 years, say insurance experts.
It pays to shop around before purchasing insurance.
3. If you work part time, make sure your premium reflects that
Physicians who see patients part time can receive up to a 75% discount on their medical liability insurance premiums.
The discounts are based on the hours the physician works per week. The fewer hours worked, the larger the discount. This type of discount does not vary by specialty.
According to The Doctors Company, working 10 hours or less per week may entitle doctors to a 75% discount; working 11-20 hours per week may entitle them to a 50% discount, and working 21-30 hours per week may entitle them to a 25% discount. If you are in this situation, it pays to ask your insurer if there is a discount available to you.
4. Look into your professional medical society insurance company
“I would look at your state medical association [or] state specialty society and talk to your colleagues to learn what premiums they’re paying and about any discounts they’re getting,” advised Mr. Zetter.
Some state medical societies have formed their own liability companies and offer lower premiums to their members because “they’re organized and managed by doctors, which makes their premiums more competitive,” Dr. Price said.
Other state medical societies endorse specific insurance carriers and offer their members a 5% discount for enrolling with them.
5. Enroll in a risk management program
Most insurers offer online educational activities designed to improve patient safety and reduce the risk of a lawsuit. Physicians may be eligible for both premium discounts and CME credits.
Medical Liability Mutual Insurance Company, owned by Berkshire Hathaway, operates in New York and offers physicians a premium discount of up to 5%, CME credit, and maintenance of certification credit for successfully completing its risk management program every other year.
ProAssurance members nationwide can earn 5% in premium discounts if they complete a 2-hour video series called “Back to Basics: Loss Prevention and Navigating Everyday Risks: Using Data to Drive Change.”
They can earn one credit for completing each webinar on topics such as “Medication Management: Minimizing Errors and Improving Safety” and “Opioid Prescribing: Keeping Patients Safe.”
MagMutual offers its insured physicians 1 CME credit for completing their specialty’s risk assessment and courses, which may be applied toward their premium discounts.
The Doctors Company offers its members a 5% premium discount if they complete 4 CME credits. One of its most popular courses is “How To Get Rid of a Difficult Patient.”
“Busy residents like the shorter case studies worth one-quarter credit that they can complete in 15 minutes,” said Ms. Boisvert.
“This is a good bargain from the physician’s standpoint and the fact that risk management education is offered online makes it a lot easier than going to a seminar in person,” said Dr. Price.
A version of this article first appeared on Medscape.com.
Getting a better deal might simply mean taking advantage of incentives and discounts your insurer may already offer. These include claims-free, new-to-practice, and working part-time discounts.
However, if you decide to shop around, keep in mind that discounts are just one factor that can affect your premium price – insurers look at your specialty, location, and claims history.
One of the most common ways physicians can earn discounts is by participating in risk management programs. With this type of program, physicians evaluate elements of their practice and documentation practices and identify areas that might leave them at risk for a lawsuit. While they save money, physician risk management programs also are designed to reduce malpractice claims, which ultimately minimizes the potential for bigger financial losses, insurance experts say.
“It’s a win-win situation when liability insurers and physicians work together to minimize risk, and it’s a win for patients,” said Gary Price, MD, president of The Physicians Foundation.
Doctors in private practice or employed by small hospitals that are not self-insured can qualify for these discounts, said David Zetter, president of Zetter HealthCare Management Consultants.
“I do a lot of work with medical malpractice companies trying to find clients policies. All the carriers are transparent about what physicians have to do to lower their premiums. Physicians can receive the discounts if they follow through and meet the insurer’s requirements,” said Mr. Zetter.
State insurance departments regulate medical malpractice insurance, including the premium credits insurers offer. Most states cap discounts at 25%, but some go as high as 70%, according to The Doctors Company, a national physician-owned medical malpractice insurer.
Insurers typically offer doctors several ways to earn discounts. The size of the discount also can depend on whether a doctor is new to a practice, remains claims free, or takes risk management courses.
In addition to the premium discount, some online risk management classes and webinars are eligible for CME credits.
“The credits can add up and they can be used for recertification or relicensure,” said Susan Boisvert, senior patient safety risk manager at The Doctors Company.
Here are five ways you may qualify for discounts with your insurer.
1. Make use of discounts available to new doctors
Doctors can earn hefty discounts on their premiums when they are no longer interns or residents and start practicing medicine. The Doctors Company usually gives a 50% discount on member premiums the first year they’re in practice and a 25% discount credit in their second year. The discounts end after that.
Other insurance carriers offer similar discounts to doctors starting to practice medicine. The deepest one is offered in the first year (at least 50%) and a smaller one (20%-25%) the second year, according to medical malpractice brokers.
“The new-to-practice discount is based solely on when the physician left their formal training to begin their practice for the first time; it is not based on claim-free history,” explained Mr. Zetter.
This is a very common discount used by different insurer carriers, said Dr. Price. “New physicians don’t have the same amount of risk of a lawsuit when they’re starting out. It’s unlikely they will have a claim and most liability actions have a 2-year time limit from the date of injury to be filed.”
2. Take advantage of being claims free
If you’ve been claims free for at least a few years, you may be eligible for a large discount.
“Doctors without claims are a better risk. Once a doctor has one claim, they’re likely to have a second, which the research shows,” said Mr. Zetter.
The most common credit The Doctors Company offers is 3 years of being claim free – this earns doctors up to 25%, he said. Mr. Zetter explained that the criteria and size of The Doctors Company credit may depend on the state where physicians practice.
“We allowed insurance carriers that we acquired to continue with their own claim-free discount program such as Florida’s First Professionals Insurance Company we acquired in 2011,” he said.
Doctors with other medical malpractice insurers may also be eligible for a credit up to 25%. In some instances, they may have to be claims free for 5 or 10 years, say insurance experts.
It pays to shop around before purchasing insurance.
3. If you work part time, make sure your premium reflects that
Physicians who see patients part time can receive up to a 75% discount on their medical liability insurance premiums.
The discounts are based on the hours the physician works per week. The fewer hours worked, the larger the discount. This type of discount does not vary by specialty.
According to The Doctors Company, working 10 hours or less per week may entitle doctors to a 75% discount; working 11-20 hours per week may entitle them to a 50% discount, and working 21-30 hours per week may entitle them to a 25% discount. If you are in this situation, it pays to ask your insurer if there is a discount available to you.
4. Look into your professional medical society insurance company
“I would look at your state medical association [or] state specialty society and talk to your colleagues to learn what premiums they’re paying and about any discounts they’re getting,” advised Mr. Zetter.
Some state medical societies have formed their own liability companies and offer lower premiums to their members because “they’re organized and managed by doctors, which makes their premiums more competitive,” Dr. Price said.
Other state medical societies endorse specific insurance carriers and offer their members a 5% discount for enrolling with them.
5. Enroll in a risk management program
Most insurers offer online educational activities designed to improve patient safety and reduce the risk of a lawsuit. Physicians may be eligible for both premium discounts and CME credits.
Medical Liability Mutual Insurance Company, owned by Berkshire Hathaway, operates in New York and offers physicians a premium discount of up to 5%, CME credit, and maintenance of certification credit for successfully completing its risk management program every other year.
ProAssurance members nationwide can earn 5% in premium discounts if they complete a 2-hour video series called “Back to Basics: Loss Prevention and Navigating Everyday Risks: Using Data to Drive Change.”
They can earn one credit for completing each webinar on topics such as “Medication Management: Minimizing Errors and Improving Safety” and “Opioid Prescribing: Keeping Patients Safe.”
MagMutual offers its insured physicians 1 CME credit for completing their specialty’s risk assessment and courses, which may be applied toward their premium discounts.
The Doctors Company offers its members a 5% premium discount if they complete 4 CME credits. One of its most popular courses is “How To Get Rid of a Difficult Patient.”
“Busy residents like the shorter case studies worth one-quarter credit that they can complete in 15 minutes,” said Ms. Boisvert.
“This is a good bargain from the physician’s standpoint and the fact that risk management education is offered online makes it a lot easier than going to a seminar in person,” said Dr. Price.
A version of this article first appeared on Medscape.com.
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
Boys may carry the weight, or overweight, of adults’ infertility
Overweight boy, infertile man?
When it comes to causes of infertility, history and science have generally focused on women. A lot of the research overlooks men, but some previous studies have suggested that male infertility contributes to about half of the cases of couple infertility. The reason for much of that male infertility, however, has been a mystery. Until now.
A group of Italian investigators looked at the declining trend in sperm counts over the past 40 years and the increase of childhood obesity. Is there a correlation? The researchers think so. Childhood obesity can be linked to multiple causes, but the researchers zeroed in on the effect that obesity has on metabolic rates and, therefore, testicular growth.
Collecting data on testicular volume, body mass index (BMI), and insulin resistance from 268 boys aged 2-18 years, the researchers discovered that those with normal weight and normal insulin levels had testicular volumes 1.5 times higher than their overweight counterparts and 1.5-2 times higher than those with hyperinsulinemia, building a case for obesity being a factor for infertility later in life.
Since low testicular volume is associated with lower sperm count and production as an adult, putting two and two together makes a compelling argument for childhood obesity being a major male infertility culprit. It also creates even more urgency for the health care industry and community decision makers to focus on childhood obesity.
It sure would be nice to be able to take one of the many risk factors for future human survival off the table. Maybe by taking something, like cake, off the table.
Fecal transplantation moves to the kitchen
Fecal microbiota transplantation is an effective way to treat Clostridioides difficile infection, but, in the end, it’s still a transplantation procedure involving a nasogastric or colorectal tube or rather large oral capsules with a demanding (30-40 capsules over 2 days) dosage. Please, Science, tell us there’s a better way.
Science, in the form of investigators at the University of Geneva and Lausanne University Hospital in Switzerland, has spoken, and there may be a better way. Presenting fecal beads: All the bacterial goodness of donor stool without the tubal insertions or massive quantities of giant capsules.
We know you’re scoffing out there, but it’s true. All you need is a little alginate, which is a “biocompatible polysaccharide isolated from brown algae” of the Phaeophyceae family. The donor feces is microencapsulated by mixing it with the alginate, dropping that mixture into water containing calcium chloride, turning it into a gel, and then freeze-drying the gel into small (just 2 mm), solid beads.
Sounds plausible enough, but what do you do with them? “These brownish beads can be easily dispersed in a liquid or food that is pleasant to eat. They also have no taste,” senior author Eric Allémann, PhD, said in a statement released by the University of Geneva.
Pleasant to eat? No taste? So which is it? If you really want to know, watch fecal beads week on the new season of “The Great British Baking Show,” when Paul and Prue judge poop baked into crumpets, crepes, and crostatas. Yum.
We’re on the low-oxygen diet
Nine out of ten doctors agree: Oxygen is more important to your continued well-being than food. After all, a human can go weeks without food, but just minutes without oxygen. However, ten out of ten doctors agree that the United States has an obesity problem. They all also agree that previous research has shown soldiers who train at high altitudes lose more weight than those training at lower altitudes.
So, on the one hand, we have a country full of overweight people, and on the other, we have low oxygen levels causing weight loss. The solution, then, is obvious: Stop breathing.
More specifically (and somewhat less facetiously), researchers from Louisiana have launched the Low Oxygen and Weight Status trial and are currently recruiting individuals with BMIs of 30-40 to, uh, suffocate themselves. No, no, it’s okay, it’s just when they’re sleeping.
Fine, straight face. Participants in the LOWS trial will undergo an 8-week period when they will consume a controlled weight-loss diet and spend their nights in a hypoxic sealed tent, where they will sleep in an environment with an oxygen level equivalent to 8,500 feet above sea level (roughly equivalent to Aspen, Colo.). They will be compared with people on the same diet who sleep in a normal, sea-level oxygen environment.
The study’s goal is to determine whether or not spending time in a low-oxygen environment will suppress appetite, increase energy expenditure, and improve weight loss and insulin sensitivity. Excessive weight loss in high-altitude environments isn’t a good thing for soldiers – they kind of need their muscles and body weight to do the whole soldiering thing – but it could be great for people struggling to lose those last few pounds. And it also may prove LOTME’s previous thesis: Air is not good.
Overweight boy, infertile man?
When it comes to causes of infertility, history and science have generally focused on women. A lot of the research overlooks men, but some previous studies have suggested that male infertility contributes to about half of the cases of couple infertility. The reason for much of that male infertility, however, has been a mystery. Until now.
A group of Italian investigators looked at the declining trend in sperm counts over the past 40 years and the increase of childhood obesity. Is there a correlation? The researchers think so. Childhood obesity can be linked to multiple causes, but the researchers zeroed in on the effect that obesity has on metabolic rates and, therefore, testicular growth.
Collecting data on testicular volume, body mass index (BMI), and insulin resistance from 268 boys aged 2-18 years, the researchers discovered that those with normal weight and normal insulin levels had testicular volumes 1.5 times higher than their overweight counterparts and 1.5-2 times higher than those with hyperinsulinemia, building a case for obesity being a factor for infertility later in life.
Since low testicular volume is associated with lower sperm count and production as an adult, putting two and two together makes a compelling argument for childhood obesity being a major male infertility culprit. It also creates even more urgency for the health care industry and community decision makers to focus on childhood obesity.
It sure would be nice to be able to take one of the many risk factors for future human survival off the table. Maybe by taking something, like cake, off the table.
Fecal transplantation moves to the kitchen
Fecal microbiota transplantation is an effective way to treat Clostridioides difficile infection, but, in the end, it’s still a transplantation procedure involving a nasogastric or colorectal tube or rather large oral capsules with a demanding (30-40 capsules over 2 days) dosage. Please, Science, tell us there’s a better way.
Science, in the form of investigators at the University of Geneva and Lausanne University Hospital in Switzerland, has spoken, and there may be a better way. Presenting fecal beads: All the bacterial goodness of donor stool without the tubal insertions or massive quantities of giant capsules.
We know you’re scoffing out there, but it’s true. All you need is a little alginate, which is a “biocompatible polysaccharide isolated from brown algae” of the Phaeophyceae family. The donor feces is microencapsulated by mixing it with the alginate, dropping that mixture into water containing calcium chloride, turning it into a gel, and then freeze-drying the gel into small (just 2 mm), solid beads.
Sounds plausible enough, but what do you do with them? “These brownish beads can be easily dispersed in a liquid or food that is pleasant to eat. They also have no taste,” senior author Eric Allémann, PhD, said in a statement released by the University of Geneva.
Pleasant to eat? No taste? So which is it? If you really want to know, watch fecal beads week on the new season of “The Great British Baking Show,” when Paul and Prue judge poop baked into crumpets, crepes, and crostatas. Yum.
We’re on the low-oxygen diet
Nine out of ten doctors agree: Oxygen is more important to your continued well-being than food. After all, a human can go weeks without food, but just minutes without oxygen. However, ten out of ten doctors agree that the United States has an obesity problem. They all also agree that previous research has shown soldiers who train at high altitudes lose more weight than those training at lower altitudes.
So, on the one hand, we have a country full of overweight people, and on the other, we have low oxygen levels causing weight loss. The solution, then, is obvious: Stop breathing.
More specifically (and somewhat less facetiously), researchers from Louisiana have launched the Low Oxygen and Weight Status trial and are currently recruiting individuals with BMIs of 30-40 to, uh, suffocate themselves. No, no, it’s okay, it’s just when they’re sleeping.
Fine, straight face. Participants in the LOWS trial will undergo an 8-week period when they will consume a controlled weight-loss diet and spend their nights in a hypoxic sealed tent, where they will sleep in an environment with an oxygen level equivalent to 8,500 feet above sea level (roughly equivalent to Aspen, Colo.). They will be compared with people on the same diet who sleep in a normal, sea-level oxygen environment.
The study’s goal is to determine whether or not spending time in a low-oxygen environment will suppress appetite, increase energy expenditure, and improve weight loss and insulin sensitivity. Excessive weight loss in high-altitude environments isn’t a good thing for soldiers – they kind of need their muscles and body weight to do the whole soldiering thing – but it could be great for people struggling to lose those last few pounds. And it also may prove LOTME’s previous thesis: Air is not good.
Overweight boy, infertile man?
When it comes to causes of infertility, history and science have generally focused on women. A lot of the research overlooks men, but some previous studies have suggested that male infertility contributes to about half of the cases of couple infertility. The reason for much of that male infertility, however, has been a mystery. Until now.
A group of Italian investigators looked at the declining trend in sperm counts over the past 40 years and the increase of childhood obesity. Is there a correlation? The researchers think so. Childhood obesity can be linked to multiple causes, but the researchers zeroed in on the effect that obesity has on metabolic rates and, therefore, testicular growth.
Collecting data on testicular volume, body mass index (BMI), and insulin resistance from 268 boys aged 2-18 years, the researchers discovered that those with normal weight and normal insulin levels had testicular volumes 1.5 times higher than their overweight counterparts and 1.5-2 times higher than those with hyperinsulinemia, building a case for obesity being a factor for infertility later in life.
Since low testicular volume is associated with lower sperm count and production as an adult, putting two and two together makes a compelling argument for childhood obesity being a major male infertility culprit. It also creates even more urgency for the health care industry and community decision makers to focus on childhood obesity.
It sure would be nice to be able to take one of the many risk factors for future human survival off the table. Maybe by taking something, like cake, off the table.
Fecal transplantation moves to the kitchen
Fecal microbiota transplantation is an effective way to treat Clostridioides difficile infection, but, in the end, it’s still a transplantation procedure involving a nasogastric or colorectal tube or rather large oral capsules with a demanding (30-40 capsules over 2 days) dosage. Please, Science, tell us there’s a better way.
Science, in the form of investigators at the University of Geneva and Lausanne University Hospital in Switzerland, has spoken, and there may be a better way. Presenting fecal beads: All the bacterial goodness of donor stool without the tubal insertions or massive quantities of giant capsules.
We know you’re scoffing out there, but it’s true. All you need is a little alginate, which is a “biocompatible polysaccharide isolated from brown algae” of the Phaeophyceae family. The donor feces is microencapsulated by mixing it with the alginate, dropping that mixture into water containing calcium chloride, turning it into a gel, and then freeze-drying the gel into small (just 2 mm), solid beads.
Sounds plausible enough, but what do you do with them? “These brownish beads can be easily dispersed in a liquid or food that is pleasant to eat. They also have no taste,” senior author Eric Allémann, PhD, said in a statement released by the University of Geneva.
Pleasant to eat? No taste? So which is it? If you really want to know, watch fecal beads week on the new season of “The Great British Baking Show,” when Paul and Prue judge poop baked into crumpets, crepes, and crostatas. Yum.
We’re on the low-oxygen diet
Nine out of ten doctors agree: Oxygen is more important to your continued well-being than food. After all, a human can go weeks without food, but just minutes without oxygen. However, ten out of ten doctors agree that the United States has an obesity problem. They all also agree that previous research has shown soldiers who train at high altitudes lose more weight than those training at lower altitudes.
So, on the one hand, we have a country full of overweight people, and on the other, we have low oxygen levels causing weight loss. The solution, then, is obvious: Stop breathing.
More specifically (and somewhat less facetiously), researchers from Louisiana have launched the Low Oxygen and Weight Status trial and are currently recruiting individuals with BMIs of 30-40 to, uh, suffocate themselves. No, no, it’s okay, it’s just when they’re sleeping.
Fine, straight face. Participants in the LOWS trial will undergo an 8-week period when they will consume a controlled weight-loss diet and spend their nights in a hypoxic sealed tent, where they will sleep in an environment with an oxygen level equivalent to 8,500 feet above sea level (roughly equivalent to Aspen, Colo.). They will be compared with people on the same diet who sleep in a normal, sea-level oxygen environment.
The study’s goal is to determine whether or not spending time in a low-oxygen environment will suppress appetite, increase energy expenditure, and improve weight loss and insulin sensitivity. Excessive weight loss in high-altitude environments isn’t a good thing for soldiers – they kind of need their muscles and body weight to do the whole soldiering thing – but it could be great for people struggling to lose those last few pounds. And it also may prove LOTME’s previous thesis: Air is not good.
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