In a huge win for patients, Medicare will begin covering colonoscopies after a positive noninvasive stool test starting in 2023. Medicare was previously the only insurer who did not cover this critical prevention procedure.

This change comes after a year of advocacy led by AGA – including multiple meetings with senior officials at HHS and legislative pressure by members across the country.

“Cost-sharing is a well-recognized barrier to screening and has resulted in disparities. Patients can now engage in CRC screening program and be confident that they will not face unexpected cost-sharing for colonoscopy after a positive noninvasive screening test,” said David Lieberman, MD, AGAF, who met with Centers for Medicare & Medicaid Services officials multiple times to push this policy forward. “AGA knows that increased participation in screening will further reduce the burden of colorectal cancer.”

“This is a win for all patients and should elevate our nation’s screening rates while lowering the overall cancer burden, saving lives. Importantly, the CMS proposed rule changes will lessen colorectal cancer disparities eliminating a financial burden for many patients,” said AGA president John Carethers, MD, AGAF, who met with CMS in early July to advocate for this change.

Thank you to everyone in the GI community who advocated for this important change!

CMS announced the coverage change as part of the 2023 Medicare proposed rule, which was released July 7, 2022. The rule must be finalized this fall before taking effect Jan. 2, 2023.










 

In a huge win for patients, Medicare will begin covering colonoscopies after a positive noninvasive stool test starting in 2023. Medicare was previously the only insurer who did not cover this critical prevention procedure.

This change comes after a year of advocacy led by AGA – including multiple meetings with senior officials at HHS and legislative pressure by members across the country.

“Cost-sharing is a well-recognized barrier to screening and has resulted in disparities. Patients can now engage in CRC screening program and be confident that they will not face unexpected cost-sharing for colonoscopy after a positive noninvasive screening test,” said David Lieberman, MD, AGAF, who met with Centers for Medicare & Medicaid Services officials multiple times to push this policy forward. “AGA knows that increased participation in screening will further reduce the burden of colorectal cancer.”

“This is a win for all patients and should elevate our nation’s screening rates while lowering the overall cancer burden, saving lives. Importantly, the CMS proposed rule changes will lessen colorectal cancer disparities eliminating a financial burden for many patients,” said AGA president John Carethers, MD, AGAF, who met with CMS in early July to advocate for this change.

Thank you to everyone in the GI community who advocated for this important change!

CMS announced the coverage change as part of the 2023 Medicare proposed rule, which was released July 7, 2022. The rule must be finalized this fall before taking effect Jan. 2, 2023.










 

In a huge win for patients, Medicare will begin covering colonoscopies after a positive noninvasive stool test starting in 2023. Medicare was previously the only insurer who did not cover this critical prevention procedure.

This change comes after a year of advocacy led by AGA – including multiple meetings with senior officials at HHS and legislative pressure by members across the country.

“Cost-sharing is a well-recognized barrier to screening and has resulted in disparities. Patients can now engage in CRC screening program and be confident that they will not face unexpected cost-sharing for colonoscopy after a positive noninvasive screening test,” said David Lieberman, MD, AGAF, who met with Centers for Medicare & Medicaid Services officials multiple times to push this policy forward. “AGA knows that increased participation in screening will further reduce the burden of colorectal cancer.”

“This is a win for all patients and should elevate our nation’s screening rates while lowering the overall cancer burden, saving lives. Importantly, the CMS proposed rule changes will lessen colorectal cancer disparities eliminating a financial burden for many patients,” said AGA president John Carethers, MD, AGAF, who met with CMS in early July to advocate for this change.

Thank you to everyone in the GI community who advocated for this important change!

CMS announced the coverage change as part of the 2023 Medicare proposed rule, which was released July 7, 2022. The rule must be finalized this fall before taking effect Jan. 2, 2023.










 

Join us at AGA Advocacy Day on Thursday, Sept. 22, 2022, to virtually meet with your members of Congress to urge them to rein in insurance policies like prior authorization and step therapy.

If GI providers don’t have a seat at the table and engage with lawmakers, these decisions will be influenced by payers and other parties that do not have your or your patients’ best interests at heart.

AGA Advocacy Day is held shortly before the end of the fiscal year – prime time to educate policymakers and their staff about your everyday challenges and the reality of GI patient care in your state. We will also discuss the need for robust federal funding for GI research and the devastating impact that Medicare cuts could have on your practice.

Register today and AGA will take care of the rest, including scheduling your meetings and providing comprehensive advocacy training. Now more than ever, your voice needs to be heard on Capitol Hill.

Join us at AGA Advocacy Day on Thursday, Sept. 22, 2022, to virtually meet with your members of Congress to urge them to rein in insurance policies like prior authorization and step therapy.

If GI providers don’t have a seat at the table and engage with lawmakers, these decisions will be influenced by payers and other parties that do not have your or your patients’ best interests at heart.

AGA Advocacy Day is held shortly before the end of the fiscal year – prime time to educate policymakers and their staff about your everyday challenges and the reality of GI patient care in your state. We will also discuss the need for robust federal funding for GI research and the devastating impact that Medicare cuts could have on your practice.

Register today and AGA will take care of the rest, including scheduling your meetings and providing comprehensive advocacy training. Now more than ever, your voice needs to be heard on Capitol Hill.

Join us at AGA Advocacy Day on Thursday, Sept. 22, 2022, to virtually meet with your members of Congress to urge them to rein in insurance policies like prior authorization and step therapy.

If GI providers don’t have a seat at the table and engage with lawmakers, these decisions will be influenced by payers and other parties that do not have your or your patients’ best interests at heart.

AGA Advocacy Day is held shortly before the end of the fiscal year – prime time to educate policymakers and their staff about your everyday challenges and the reality of GI patient care in your state. We will also discuss the need for robust federal funding for GI research and the devastating impact that Medicare cuts could have on your practice.

Register today and AGA will take care of the rest, including scheduling your meetings and providing comprehensive advocacy training. Now more than ever, your voice needs to be heard on Capitol Hill.

On July 7, the Centers for Medicare & Medicaid Services released the calendar year (CY) 2023 Medicare Physician Fee Schedule Proposed Rule and can now be found in the Federal Register.

Good news!

In a win for patients, and thanks to collective advocacy efforts from AGA and partner societies, CMS is proposing to expand the regulatory definition of “colorectal cancer screening tests” and waive cost sharing for a necessary follow-up colonoscopy after a positive stool-based screening test.

Looming cuts 

The rule proposes 4% cuts to Medicare physician reimbursement through required decreases in the conversion factor and expiration of temporary fixes passed by Congress. AGA will continue to work with a coalition of national and state medical societies in urging Congress to prevent these cuts before Jan. 1, 2023.

What to know

• CMS expands colorectal cancer screening in a proposal to waive cost sharing for a follow-up colonoscopy to a positive stool-based colorectal cancer screening test and to cover the service for individuals 45 years of age and above.
• Medicare payment cuts are looming with cuts to the proposed CY 2023 conversion factor.
• Split/shared visits policy delayed until CY 2024.
• Payment rates for new bariatric device codes proposed.

On July 7, the Centers for Medicare & Medicaid Services released the calendar year (CY) 2023 Medicare Physician Fee Schedule Proposed Rule and can now be found in the Federal Register.

Good news!

In a win for patients, and thanks to collective advocacy efforts from AGA and partner societies, CMS is proposing to expand the regulatory definition of “colorectal cancer screening tests” and waive cost sharing for a necessary follow-up colonoscopy after a positive stool-based screening test.

Looming cuts 

The rule proposes 4% cuts to Medicare physician reimbursement through required decreases in the conversion factor and expiration of temporary fixes passed by Congress. AGA will continue to work with a coalition of national and state medical societies in urging Congress to prevent these cuts before Jan. 1, 2023.

What to know

• CMS expands colorectal cancer screening in a proposal to waive cost sharing for a follow-up colonoscopy to a positive stool-based colorectal cancer screening test and to cover the service for individuals 45 years of age and above.
• Medicare payment cuts are looming with cuts to the proposed CY 2023 conversion factor.
• Split/shared visits policy delayed until CY 2024.
• Payment rates for new bariatric device codes proposed.

On July 7, the Centers for Medicare & Medicaid Services released the calendar year (CY) 2023 Medicare Physician Fee Schedule Proposed Rule and can now be found in the Federal Register.

Good news!

In a win for patients, and thanks to collective advocacy efforts from AGA and partner societies, CMS is proposing to expand the regulatory definition of “colorectal cancer screening tests” and waive cost sharing for a necessary follow-up colonoscopy after a positive stool-based screening test.

Looming cuts 

The rule proposes 4% cuts to Medicare physician reimbursement through required decreases in the conversion factor and expiration of temporary fixes passed by Congress. AGA will continue to work with a coalition of national and state medical societies in urging Congress to prevent these cuts before Jan. 1, 2023.

What to know

• CMS expands colorectal cancer screening in a proposal to waive cost sharing for a follow-up colonoscopy to a positive stool-based colorectal cancer screening test and to cover the service for individuals 45 years of age and above.
• Medicare payment cuts are looming with cuts to the proposed CY 2023 conversion factor.
• Split/shared visits policy delayed until CY 2024.
• Payment rates for new bariatric device codes proposed.

The American Gastroenterological Association Research Foundation is the charitable arm of the AGA and plays an important role in medical research by providing grants to young scientists at a critical time in their career.

“I am beyond excited to be able to continue my journey as a young physician-scientist with the funding support. I truly understand that my career would not be possible without those who generously support scientific research. I am humbled at the opportunity to contribute to something larger than myself. As such, I am extremely grateful to the AGA Research Foundation and its donors who continue to support this vision of a future where suffering related to digestive diseases has been eliminated,” said Brian A. Sullivan, MD, a 2021 AGA Research Scholar Award recipient, who is a physician-scientist who aspires to lead a collaborative research program and develop more effective strategies for colorectal cancer prevention.

In the past decade alone, we’ve witnessed seminal work in colorectal cancer genetics and a renaissance in the understanding of inflammatory bowel syndrome and the gut microbiome. However, continued progress in advancing the treatment and cure of digestive diseases is at risk because of cuts in government spending. Without help from other funding sources, young investigators are struggling to continue their research, build their research portfolio, and obtain federal funding.
 

Your contribution makes a difference 

With donations from AGA members, we can provide young researchers with a secure, ongoing stable source of funding that drives advancement in the diagnosis, treatment and cure of digestive diseases. Everyone benefits from GI research developed by dedicated investigators.

“I donated to the AGA Research Foundation to ensure the vitality of our specialty, and to fund the research of future generations of gastroenterologists. Funding from organizations like the AGA Research Foundation is crucial for young scientists and gastroenterologists to launch their careers. At the start of my career, I received two AGA research awards. As a grateful recipient of such funding, I felt it was my turn to support the mission of the organization that I regard as my academic home away from home institution,” said Michael Camilleri, MD, AGAF, chair of the AGA Research Foundation and AGA Past President.

Many breakthroughs have been achieved through gastroenterological and hepatological research over the past century, forming the basis of the modern medical practice. Join fellow AGA members by contributing to this tradition of discovery. 

Make a tax-deductible donation to the AGA Research Foundation at www.gastro.org/donate or by mail to 4930 Del Ray Avenue, Bethesda, MD 20814.

Learn more about the AGA Research Foundation at https://foundation.gastro.org. 

The American Gastroenterological Association Research Foundation is the charitable arm of the AGA and plays an important role in medical research by providing grants to young scientists at a critical time in their career.

“I am beyond excited to be able to continue my journey as a young physician-scientist with the funding support. I truly understand that my career would not be possible without those who generously support scientific research. I am humbled at the opportunity to contribute to something larger than myself. As such, I am extremely grateful to the AGA Research Foundation and its donors who continue to support this vision of a future where suffering related to digestive diseases has been eliminated,” said Brian A. Sullivan, MD, a 2021 AGA Research Scholar Award recipient, who is a physician-scientist who aspires to lead a collaborative research program and develop more effective strategies for colorectal cancer prevention.

In the past decade alone, we’ve witnessed seminal work in colorectal cancer genetics and a renaissance in the understanding of inflammatory bowel syndrome and the gut microbiome. However, continued progress in advancing the treatment and cure of digestive diseases is at risk because of cuts in government spending. Without help from other funding sources, young investigators are struggling to continue their research, build their research portfolio, and obtain federal funding.
 

Your contribution makes a difference 

With donations from AGA members, we can provide young researchers with a secure, ongoing stable source of funding that drives advancement in the diagnosis, treatment and cure of digestive diseases. Everyone benefits from GI research developed by dedicated investigators.

“I donated to the AGA Research Foundation to ensure the vitality of our specialty, and to fund the research of future generations of gastroenterologists. Funding from organizations like the AGA Research Foundation is crucial for young scientists and gastroenterologists to launch their careers. At the start of my career, I received two AGA research awards. As a grateful recipient of such funding, I felt it was my turn to support the mission of the organization that I regard as my academic home away from home institution,” said Michael Camilleri, MD, AGAF, chair of the AGA Research Foundation and AGA Past President.

Many breakthroughs have been achieved through gastroenterological and hepatological research over the past century, forming the basis of the modern medical practice. Join fellow AGA members by contributing to this tradition of discovery. 

Make a tax-deductible donation to the AGA Research Foundation at www.gastro.org/donate or by mail to 4930 Del Ray Avenue, Bethesda, MD 20814.

Learn more about the AGA Research Foundation at https://foundation.gastro.org. 

The American Gastroenterological Association Research Foundation is the charitable arm of the AGA and plays an important role in medical research by providing grants to young scientists at a critical time in their career.

“I am beyond excited to be able to continue my journey as a young physician-scientist with the funding support. I truly understand that my career would not be possible without those who generously support scientific research. I am humbled at the opportunity to contribute to something larger than myself. As such, I am extremely grateful to the AGA Research Foundation and its donors who continue to support this vision of a future where suffering related to digestive diseases has been eliminated,” said Brian A. Sullivan, MD, a 2021 AGA Research Scholar Award recipient, who is a physician-scientist who aspires to lead a collaborative research program and develop more effective strategies for colorectal cancer prevention.

In the past decade alone, we’ve witnessed seminal work in colorectal cancer genetics and a renaissance in the understanding of inflammatory bowel syndrome and the gut microbiome. However, continued progress in advancing the treatment and cure of digestive diseases is at risk because of cuts in government spending. Without help from other funding sources, young investigators are struggling to continue their research, build their research portfolio, and obtain federal funding.
 

Your contribution makes a difference 

With donations from AGA members, we can provide young researchers with a secure, ongoing stable source of funding that drives advancement in the diagnosis, treatment and cure of digestive diseases. Everyone benefits from GI research developed by dedicated investigators.

“I donated to the AGA Research Foundation to ensure the vitality of our specialty, and to fund the research of future generations of gastroenterologists. Funding from organizations like the AGA Research Foundation is crucial for young scientists and gastroenterologists to launch their careers. At the start of my career, I received two AGA research awards. As a grateful recipient of such funding, I felt it was my turn to support the mission of the organization that I regard as my academic home away from home institution,” said Michael Camilleri, MD, AGAF, chair of the AGA Research Foundation and AGA Past President.

Many breakthroughs have been achieved through gastroenterological and hepatological research over the past century, forming the basis of the modern medical practice. Join fellow AGA members by contributing to this tradition of discovery. 

Make a tax-deductible donation to the AGA Research Foundation at www.gastro.org/donate or by mail to 4930 Del Ray Avenue, Bethesda, MD 20814.

Learn more about the AGA Research Foundation at https://foundation.gastro.org. 

Transgender children, even those as young as 9 or 10 years old, already show increased susceptibility to mental health problems compared with their cisgender peers, new research suggests.

Investigators assessed a sample of more than 7000 children aged 9-10 years in the general population and found those who reported being transgender scored considerably higher on all six subscales of the DSM-5-oriented Child Behavior Checklist (CBCL).

Transgender children had almost sixfold higher odds of suicidality and over twice the odds of depressive and anxiety problems, compared with cisgender children. Moreover, transgender children displayed higher levels of mental health problems compared with previous studies of transgender children recruited from specialist gender clinics.

“Our findings emphasize the vulnerability of transgender children, including those who may not yet have accessed specialist support,” senior author Kenneth C. Pang, MBBS, BMedSc, PhD, associate professor, Murdoch Children’s Research Institute, University of Melbourne, Royal Children’s Hospital, Australia, told this news organization.

“Clinicians providing general health care to transgender children should keep this vulnerability in mind and proactively address any mental health problems that exist,” he said.

The findings were published online as a research letter in JAMA Network Open.
 

Higher levels of support?

“We felt this study was important to conduct because previous studies regarding the mental health of transgender children have been drawn from children receiving specialist gender-related care,” Dr. Pang said.

“Transgender children receiving such care are likely to enjoy higher levels of support than those unable to access such services, and this might create differences in mental health,” he added.

To investigate this issue, the researchers turned to participants (n = 7,169; mean age, 10.3 years) in the Adolescent Brain Cognitive Development (ABCD) study.

“The ABCD study is a longitudinal study of over 11,000 children who were recruited to reflect the sociodemographic variation of the U.S. population,” lead author Douglas H. Russell, MSc, a PhD candidate at the University of Melbourne, told this news organization.

To be included in the current study, children had to understand and respond to the question “Are you transgender?”

The researchers compared mental health outcomes between transgender and cisgender children (n = 58 and n = 7,111, respectively) using the CBCL, which study participants had completed at baseline.
 

Key protective factor

The transgender children recorded higher mean T scores for all six subscales of the CBCL, although all children scored in the references range; and the standardized mean difference was “small.”

Suicidality was measured by summing the two suicide-related items in the parent-report CBCL assessing suicidal ideation and attempts.

“For the CBCL, T scores are calculated for measures that are scored on a continuous scale,” Dr. Pang noted. “Responses to the suicidality questions on the CBCL were assessed in a categorical manner (at risk of suicide vs. not), as previously described by others. So T scores were therefore not able to be calculated.”

When the investigators determined the proportion of cisgender and transgender children who scored in the “borderline” or “clinical” range (T score, 65), they found increased odds of transgender children scoring in that range in all six subscales, as well as suicidality.

The researchers note the results for attention-deficit/hyperactivity disorder and oppositional defiant problems were not statistically significant.

Previous studies that used clinical samples of young transgender children (aged 5 -11 years) reported lower rates of depression and anxiety than what was found in the current study.

“Transgender children in the general population displayed higher levels of mental health problems compared to previous studies of transgender children recruited from specialist gender clinics,” Mr. Russell said.

One reason for that may be children in specialist clinics “are likely to have support from their families (a key protective factor for the mental health of transgender young people); in comparison, many transgender children in the general population lack parental support for their gender,” the investigators wrote.

“Our findings suggest that by 9 to 10 years of age transgender children already show increased susceptibility to mental health problems compared with their cisgender peers, which has important public health implications,” they added.

The researchers noted that whether this susceptibility “is due to stigma, minority stress, discrimination, or gender dysphoria is unclear, but providing appropriate mental health supports to this vulnerable group is paramount.”
 

“Pathologizing and damaging”

Commenting for this news organiztion, Jack L. Turban, MD, incoming assistant professor of child and adolescent psychiatry, University of California, San Francisco, said that “sadly” the findings are “largely in line with past studies that have shown dramatic mental health disparities” for transgender and gender diverse youth.

“The dramatically elevated odds of suicidality warrants particular public health concern,” said Dr. Turban, who was not involved with the study.

He noted these results “come at a time when transgender youth are under legislative attack in many states throughout the country, and the national rhetoric around them has been pathologizing and damaging.”

Dr. Turban said that he worries “if our national discourse around trans youth doesn’t change soon, that these disparities will worsen.”

Funding was provided to individual investigators by the Hugh Williamson Foundation, the Royal Children’s Hospital foundation, the National Health and Medical Research Council, and the Australian Government Research Training Program Scholarship. Mr. Russell and Dr. Pang reported being members of the Australian Professional Association for Trans Health. Dr. Pang is a member of the World Professional Association for Transgender Health and a member of the editorial board of the journal Transgender Health. Dr. Turban reported textbook royalties from Springer Nature, being on the scientific advisory board of Panorama Global (UpSwing Fund), and payments as an expert witness for the American Civil Liberties Union, Lambda Legal, and Cooley LLP. He has received a pilot research award from AACAP and pharmaceutical partners (Arbor and Pfizer), a research fellowship from the Sorensen Foundation, and freelance payments from the New York Times, the Washington Post, and the Los Angeles Times.

A version of this article first appeared on Medscape.com.

Transgender children, even those as young as 9 or 10 years old, already show increased susceptibility to mental health problems compared with their cisgender peers, new research suggests.

Investigators assessed a sample of more than 7000 children aged 9-10 years in the general population and found those who reported being transgender scored considerably higher on all six subscales of the DSM-5-oriented Child Behavior Checklist (CBCL).

Transgender children had almost sixfold higher odds of suicidality and over twice the odds of depressive and anxiety problems, compared with cisgender children. Moreover, transgender children displayed higher levels of mental health problems compared with previous studies of transgender children recruited from specialist gender clinics.

“Our findings emphasize the vulnerability of transgender children, including those who may not yet have accessed specialist support,” senior author Kenneth C. Pang, MBBS, BMedSc, PhD, associate professor, Murdoch Children’s Research Institute, University of Melbourne, Royal Children’s Hospital, Australia, told this news organization.

“Clinicians providing general health care to transgender children should keep this vulnerability in mind and proactively address any mental health problems that exist,” he said.

The findings were published online as a research letter in JAMA Network Open.
 

Higher levels of support?

“We felt this study was important to conduct because previous studies regarding the mental health of transgender children have been drawn from children receiving specialist gender-related care,” Dr. Pang said.

“Transgender children receiving such care are likely to enjoy higher levels of support than those unable to access such services, and this might create differences in mental health,” he added.

To investigate this issue, the researchers turned to participants (n = 7,169; mean age, 10.3 years) in the Adolescent Brain Cognitive Development (ABCD) study.

“The ABCD study is a longitudinal study of over 11,000 children who were recruited to reflect the sociodemographic variation of the U.S. population,” lead author Douglas H. Russell, MSc, a PhD candidate at the University of Melbourne, told this news organization.

To be included in the current study, children had to understand and respond to the question “Are you transgender?”

The researchers compared mental health outcomes between transgender and cisgender children (n = 58 and n = 7,111, respectively) using the CBCL, which study participants had completed at baseline.
 

Key protective factor

The transgender children recorded higher mean T scores for all six subscales of the CBCL, although all children scored in the references range; and the standardized mean difference was “small.”

Suicidality was measured by summing the two suicide-related items in the parent-report CBCL assessing suicidal ideation and attempts.

“For the CBCL, T scores are calculated for measures that are scored on a continuous scale,” Dr. Pang noted. “Responses to the suicidality questions on the CBCL were assessed in a categorical manner (at risk of suicide vs. not), as previously described by others. So T scores were therefore not able to be calculated.”

When the investigators determined the proportion of cisgender and transgender children who scored in the “borderline” or “clinical” range (T score, 65), they found increased odds of transgender children scoring in that range in all six subscales, as well as suicidality.

The researchers note the results for attention-deficit/hyperactivity disorder and oppositional defiant problems were not statistically significant.

Previous studies that used clinical samples of young transgender children (aged 5 -11 years) reported lower rates of depression and anxiety than what was found in the current study.

“Transgender children in the general population displayed higher levels of mental health problems compared to previous studies of transgender children recruited from specialist gender clinics,” Mr. Russell said.

One reason for that may be children in specialist clinics “are likely to have support from their families (a key protective factor for the mental health of transgender young people); in comparison, many transgender children in the general population lack parental support for their gender,” the investigators wrote.

“Our findings suggest that by 9 to 10 years of age transgender children already show increased susceptibility to mental health problems compared with their cisgender peers, which has important public health implications,” they added.

The researchers noted that whether this susceptibility “is due to stigma, minority stress, discrimination, or gender dysphoria is unclear, but providing appropriate mental health supports to this vulnerable group is paramount.”
 

“Pathologizing and damaging”

Commenting for this news organiztion, Jack L. Turban, MD, incoming assistant professor of child and adolescent psychiatry, University of California, San Francisco, said that “sadly” the findings are “largely in line with past studies that have shown dramatic mental health disparities” for transgender and gender diverse youth.

“The dramatically elevated odds of suicidality warrants particular public health concern,” said Dr. Turban, who was not involved with the study.

He noted these results “come at a time when transgender youth are under legislative attack in many states throughout the country, and the national rhetoric around them has been pathologizing and damaging.”

Dr. Turban said that he worries “if our national discourse around trans youth doesn’t change soon, that these disparities will worsen.”

Funding was provided to individual investigators by the Hugh Williamson Foundation, the Royal Children’s Hospital foundation, the National Health and Medical Research Council, and the Australian Government Research Training Program Scholarship. Mr. Russell and Dr. Pang reported being members of the Australian Professional Association for Trans Health. Dr. Pang is a member of the World Professional Association for Transgender Health and a member of the editorial board of the journal Transgender Health. Dr. Turban reported textbook royalties from Springer Nature, being on the scientific advisory board of Panorama Global (UpSwing Fund), and payments as an expert witness for the American Civil Liberties Union, Lambda Legal, and Cooley LLP. He has received a pilot research award from AACAP and pharmaceutical partners (Arbor and Pfizer), a research fellowship from the Sorensen Foundation, and freelance payments from the New York Times, the Washington Post, and the Los Angeles Times.

A version of this article first appeared on Medscape.com.

Transgender children, even those as young as 9 or 10 years old, already show increased susceptibility to mental health problems compared with their cisgender peers, new research suggests.

Investigators assessed a sample of more than 7000 children aged 9-10 years in the general population and found those who reported being transgender scored considerably higher on all six subscales of the DSM-5-oriented Child Behavior Checklist (CBCL).

Transgender children had almost sixfold higher odds of suicidality and over twice the odds of depressive and anxiety problems, compared with cisgender children. Moreover, transgender children displayed higher levels of mental health problems compared with previous studies of transgender children recruited from specialist gender clinics.

“Our findings emphasize the vulnerability of transgender children, including those who may not yet have accessed specialist support,” senior author Kenneth C. Pang, MBBS, BMedSc, PhD, associate professor, Murdoch Children’s Research Institute, University of Melbourne, Royal Children’s Hospital, Australia, told this news organization.

“Clinicians providing general health care to transgender children should keep this vulnerability in mind and proactively address any mental health problems that exist,” he said.

The findings were published online as a research letter in JAMA Network Open.
 

Higher levels of support?

“We felt this study was important to conduct because previous studies regarding the mental health of transgender children have been drawn from children receiving specialist gender-related care,” Dr. Pang said.

“Transgender children receiving such care are likely to enjoy higher levels of support than those unable to access such services, and this might create differences in mental health,” he added.

To investigate this issue, the researchers turned to participants (n = 7,169; mean age, 10.3 years) in the Adolescent Brain Cognitive Development (ABCD) study.

“The ABCD study is a longitudinal study of over 11,000 children who were recruited to reflect the sociodemographic variation of the U.S. population,” lead author Douglas H. Russell, MSc, a PhD candidate at the University of Melbourne, told this news organization.

To be included in the current study, children had to understand and respond to the question “Are you transgender?”

The researchers compared mental health outcomes between transgender and cisgender children (n = 58 and n = 7,111, respectively) using the CBCL, which study participants had completed at baseline.
 

Key protective factor

The transgender children recorded higher mean T scores for all six subscales of the CBCL, although all children scored in the references range; and the standardized mean difference was “small.”

Suicidality was measured by summing the two suicide-related items in the parent-report CBCL assessing suicidal ideation and attempts.

“For the CBCL, T scores are calculated for measures that are scored on a continuous scale,” Dr. Pang noted. “Responses to the suicidality questions on the CBCL were assessed in a categorical manner (at risk of suicide vs. not), as previously described by others. So T scores were therefore not able to be calculated.”

When the investigators determined the proportion of cisgender and transgender children who scored in the “borderline” or “clinical” range (T score, 65), they found increased odds of transgender children scoring in that range in all six subscales, as well as suicidality.

The researchers note the results for attention-deficit/hyperactivity disorder and oppositional defiant problems were not statistically significant.

Previous studies that used clinical samples of young transgender children (aged 5 -11 years) reported lower rates of depression and anxiety than what was found in the current study.

“Transgender children in the general population displayed higher levels of mental health problems compared to previous studies of transgender children recruited from specialist gender clinics,” Mr. Russell said.

One reason for that may be children in specialist clinics “are likely to have support from their families (a key protective factor for the mental health of transgender young people); in comparison, many transgender children in the general population lack parental support for their gender,” the investigators wrote.

“Our findings suggest that by 9 to 10 years of age transgender children already show increased susceptibility to mental health problems compared with their cisgender peers, which has important public health implications,” they added.

The researchers noted that whether this susceptibility “is due to stigma, minority stress, discrimination, or gender dysphoria is unclear, but providing appropriate mental health supports to this vulnerable group is paramount.”
 

“Pathologizing and damaging”

Commenting for this news organiztion, Jack L. Turban, MD, incoming assistant professor of child and adolescent psychiatry, University of California, San Francisco, said that “sadly” the findings are “largely in line with past studies that have shown dramatic mental health disparities” for transgender and gender diverse youth.

“The dramatically elevated odds of suicidality warrants particular public health concern,” said Dr. Turban, who was not involved with the study.

He noted these results “come at a time when transgender youth are under legislative attack in many states throughout the country, and the national rhetoric around them has been pathologizing and damaging.”

Dr. Turban said that he worries “if our national discourse around trans youth doesn’t change soon, that these disparities will worsen.”

Funding was provided to individual investigators by the Hugh Williamson Foundation, the Royal Children’s Hospital foundation, the National Health and Medical Research Council, and the Australian Government Research Training Program Scholarship. Mr. Russell and Dr. Pang reported being members of the Australian Professional Association for Trans Health. Dr. Pang is a member of the World Professional Association for Transgender Health and a member of the editorial board of the journal Transgender Health. Dr. Turban reported textbook royalties from Springer Nature, being on the scientific advisory board of Panorama Global (UpSwing Fund), and payments as an expert witness for the American Civil Liberties Union, Lambda Legal, and Cooley LLP. He has received a pilot research award from AACAP and pharmaceutical partners (Arbor and Pfizer), a research fellowship from the Sorensen Foundation, and freelance payments from the New York Times, the Washington Post, and the Los Angeles Times.

A version of this article first appeared on Medscape.com.

Transgender people who medically detransition – those who stop or switch gender-affirming hormone therapy or who undergo a reversal of a surgical reconstruction – report feeling stigmatized by clinicians and receiving inadequate professional support, researchers have found. As a result, such patients often avoid health care at the time they stop undergoing medical interventions, and many consider their overall care to be “suboptimal.”

“Clinicians providing gender-affirming care must be careful to avoid shaming patients who are pursuing hormonal cessation or switching or surgical reversals and instead strive to address current mental and physical health needs,” wrote the authors of the new study, which was published  in JAMA Network Open.

In a commentary accompanying the journal article, Jack L. Turban, MD, a psychiatrist at the University of California, San Francisco, argues that discontinuation of gender-affirming care is rare and is “woefully politicized”.

Dr. Turban wrote, “clinical protocols should be in place to support patients who have dynamic needs surrounding these interventions.” He added that “gender-affirming care should encompass the entirety of an individual’s embodiment goals, even when those goals may have pivoted over time.”

For the study, Kinnon R. MacKinnon, PhD, of York University, Toronto, and colleagues conducted video interviews with 28 Canadian individuals older than 18 years. All identified as “detransitioning, retransitioning, detrans, retrans, reidentifying, [experiencing] a shift in gender identity after initiating transition, or having stopped transition.”

Eighteen (64%) were assigned female sex at birth, and 10 (36%) were assigned male sex at birth. Twenty (71%) were aged 20-29; six were aged 30-39, and two were older than 40. Twenty-one were White. One participant who only socially transitioned was removed from the analysis of medical transitions. About half who medically transitioned did so between the ages of 18 and 24.

Reasons for stopping a medical transition included concerns about physical or mental health, surgical complications, postoperative pain, unsupportive parents or romantic partners, discrimination in the workplace, and difficulty accessing clinical care or gender-affirming surgery.

One participant, who had been assigned female sex at birth and who now identifies as female, said the transition did not help. The process was “a hot mess,” she said. Because she’d known people who had experienced improvements in mental and physical health as a result of transitioning, especially after initiating hormone therapy, she kept going. But, she said, “the farther I got into transition, the worse my [borderline personality disorder] symptoms and my presentation was.”
 

Lack of clinician support – going ‘cold turkey’

Many individuals reported that they stopped taking hormones “cold turkey,” without the support of a therapist or a clinician, because they did not trust health care providers or had had bad interactions with the medical system.

Most of those who had undergone gender-affirming surgical removal of testes or ovaries in their initial transition said the care they received when they decided to detransition was “bad.” Clinicians were judgmental or had inadequate knowledge about the process, the researchers reported. Some detransitioners said such encounters with clinicians added to their feelings of shame.

One participant who was born female and transitioned to male said she had good relationships with her clinicians and therapist, but she still felt “guilt and shame” about detransitioning back to female. She also worried that those clinicians would view her initial decision as a “mistake” or “through a lens of ‘regret,’ which was inauthentic to her feelings,” the researchers reported.

Another individual who had been assigned female sex at birth said that when she wanted to detransition, she consulted a physician about switching back to estrogen. “She wasn’t very tactful,” the person, who now identifies as female, recalled. “She made comments about how I should have thought about [my initial transition] harder.”

Participants said clinicians lacked sufficient information on detransitioning.

Dr. Turban noted that data are limited on the physiologic and psychological effects of discontinuing exogenous hormone therapy, “because it is such a rare occurrence.” He acknowledged that “more research is needed on the effects of discontinuation so that clinicians can better educate patients.”

The researchers found that most who sought to detransition consulted online forums and networks. The r/detrans discussion group on Reddit, for instance, now has 36,400 members.

Some reported regret that they had transitioned, while others – especially those who identify now as nonbinary or gender-fluid – said they were happy with their initial choice.

Eighteen of the 27 had no regrets and/or had positive feelings about the gender-affirming medications or procedures they had received in the past. Six (22%) had regret, and three were ambivalent. The rate of regret in the relatively small sample is higher than that observed in several other studies. Trans advocates also point out that detransitioning does not necessarily equate with regret.

When asked whether she regretted having undergone a double mastectomy, an individual who had been assigned female sex at birth and who now identifies as female said, “Some days I do, some days I don’t.” She also said she is not considering breast augmentation. “I’m just going to leave myself alone,” she said, adding that “it’s part of my journey.”

A participant who had been assigned female sex at birth and who now identifies as a cisgender woman said that she is mostly regarded by others as a trans person now, although she does not identify that way. But she said taking testosterone in the past was the right decision. “At the time, that was absolutely what I knew I had to do,” she said. “I’m actually not upset about any of the permanent changes it had on my body.”

The researchers noted that some participants said that “their parents or family circumstances explicitly forced, or implicitly encouraged detransition.”

Dr. Turban encouraged clinicians to consider how such external factors might “exacerbate internal factors,” such as internalized transphobia, which could lead to a discontinuation of gender-affirming care.

The study received funding from the Social Sciences and Humanities Research Council (SSHRC) Insight Development Program and a York University SSHRC Explore grant. Travis Salway, MD, a coauthor, has received grants from Canadian Institutes of Health Research, Michael Smith Health Research BC, BC SUPPORT Unit Fraser Centre, Simon Fraser University’s Community-Engaged Research Initiative, and the Social Sciences and Humanities Research Council outside the submitted work. The other authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

This article was been updated on 8/5/22 to include additional information about detransitioning.

Transgender people who medically detransition – those who stop or switch gender-affirming hormone therapy or who undergo a reversal of a surgical reconstruction – report feeling stigmatized by clinicians and receiving inadequate professional support, researchers have found. As a result, such patients often avoid health care at the time they stop undergoing medical interventions, and many consider their overall care to be “suboptimal.”

“Clinicians providing gender-affirming care must be careful to avoid shaming patients who are pursuing hormonal cessation or switching or surgical reversals and instead strive to address current mental and physical health needs,” wrote the authors of the new study, which was published  in JAMA Network Open.

In a commentary accompanying the journal article, Jack L. Turban, MD, a psychiatrist at the University of California, San Francisco, argues that discontinuation of gender-affirming care is rare and is “woefully politicized”.

Dr. Turban wrote, “clinical protocols should be in place to support patients who have dynamic needs surrounding these interventions.” He added that “gender-affirming care should encompass the entirety of an individual’s embodiment goals, even when those goals may have pivoted over time.”

For the study, Kinnon R. MacKinnon, PhD, of York University, Toronto, and colleagues conducted video interviews with 28 Canadian individuals older than 18 years. All identified as “detransitioning, retransitioning, detrans, retrans, reidentifying, [experiencing] a shift in gender identity after initiating transition, or having stopped transition.”

Eighteen (64%) were assigned female sex at birth, and 10 (36%) were assigned male sex at birth. Twenty (71%) were aged 20-29; six were aged 30-39, and two were older than 40. Twenty-one were White. One participant who only socially transitioned was removed from the analysis of medical transitions. About half who medically transitioned did so between the ages of 18 and 24.

Reasons for stopping a medical transition included concerns about physical or mental health, surgical complications, postoperative pain, unsupportive parents or romantic partners, discrimination in the workplace, and difficulty accessing clinical care or gender-affirming surgery.

One participant, who had been assigned female sex at birth and who now identifies as female, said the transition did not help. The process was “a hot mess,” she said. Because she’d known people who had experienced improvements in mental and physical health as a result of transitioning, especially after initiating hormone therapy, she kept going. But, she said, “the farther I got into transition, the worse my [borderline personality disorder] symptoms and my presentation was.”
 

Lack of clinician support – going ‘cold turkey’

Many individuals reported that they stopped taking hormones “cold turkey,” without the support of a therapist or a clinician, because they did not trust health care providers or had had bad interactions with the medical system.

Most of those who had undergone gender-affirming surgical removal of testes or ovaries in their initial transition said the care they received when they decided to detransition was “bad.” Clinicians were judgmental or had inadequate knowledge about the process, the researchers reported. Some detransitioners said such encounters with clinicians added to their feelings of shame.

One participant who was born female and transitioned to male said she had good relationships with her clinicians and therapist, but she still felt “guilt and shame” about detransitioning back to female. She also worried that those clinicians would view her initial decision as a “mistake” or “through a lens of ‘regret,’ which was inauthentic to her feelings,” the researchers reported.

Another individual who had been assigned female sex at birth said that when she wanted to detransition, she consulted a physician about switching back to estrogen. “She wasn’t very tactful,” the person, who now identifies as female, recalled. “She made comments about how I should have thought about [my initial transition] harder.”

Participants said clinicians lacked sufficient information on detransitioning.

Dr. Turban noted that data are limited on the physiologic and psychological effects of discontinuing exogenous hormone therapy, “because it is such a rare occurrence.” He acknowledged that “more research is needed on the effects of discontinuation so that clinicians can better educate patients.”

The researchers found that most who sought to detransition consulted online forums and networks. The r/detrans discussion group on Reddit, for instance, now has 36,400 members.

Some reported regret that they had transitioned, while others – especially those who identify now as nonbinary or gender-fluid – said they were happy with their initial choice.

Eighteen of the 27 had no regrets and/or had positive feelings about the gender-affirming medications or procedures they had received in the past. Six (22%) had regret, and three were ambivalent. The rate of regret in the relatively small sample is higher than that observed in several other studies. Trans advocates also point out that detransitioning does not necessarily equate with regret.

When asked whether she regretted having undergone a double mastectomy, an individual who had been assigned female sex at birth and who now identifies as female said, “Some days I do, some days I don’t.” She also said she is not considering breast augmentation. “I’m just going to leave myself alone,” she said, adding that “it’s part of my journey.”

A participant who had been assigned female sex at birth and who now identifies as a cisgender woman said that she is mostly regarded by others as a trans person now, although she does not identify that way. But she said taking testosterone in the past was the right decision. “At the time, that was absolutely what I knew I had to do,” she said. “I’m actually not upset about any of the permanent changes it had on my body.”

The researchers noted that some participants said that “their parents or family circumstances explicitly forced, or implicitly encouraged detransition.”

Dr. Turban encouraged clinicians to consider how such external factors might “exacerbate internal factors,” such as internalized transphobia, which could lead to a discontinuation of gender-affirming care.

The study received funding from the Social Sciences and Humanities Research Council (SSHRC) Insight Development Program and a York University SSHRC Explore grant. Travis Salway, MD, a coauthor, has received grants from Canadian Institutes of Health Research, Michael Smith Health Research BC, BC SUPPORT Unit Fraser Centre, Simon Fraser University’s Community-Engaged Research Initiative, and the Social Sciences and Humanities Research Council outside the submitted work. The other authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

This article was been updated on 8/5/22 to include additional information about detransitioning.

Transgender people who medically detransition – those who stop or switch gender-affirming hormone therapy or who undergo a reversal of a surgical reconstruction – report feeling stigmatized by clinicians and receiving inadequate professional support, researchers have found. As a result, such patients often avoid health care at the time they stop undergoing medical interventions, and many consider their overall care to be “suboptimal.”

“Clinicians providing gender-affirming care must be careful to avoid shaming patients who are pursuing hormonal cessation or switching or surgical reversals and instead strive to address current mental and physical health needs,” wrote the authors of the new study, which was published  in JAMA Network Open.

In a commentary accompanying the journal article, Jack L. Turban, MD, a psychiatrist at the University of California, San Francisco, argues that discontinuation of gender-affirming care is rare and is “woefully politicized”.

Dr. Turban wrote, “clinical protocols should be in place to support patients who have dynamic needs surrounding these interventions.” He added that “gender-affirming care should encompass the entirety of an individual’s embodiment goals, even when those goals may have pivoted over time.”

For the study, Kinnon R. MacKinnon, PhD, of York University, Toronto, and colleagues conducted video interviews with 28 Canadian individuals older than 18 years. All identified as “detransitioning, retransitioning, detrans, retrans, reidentifying, [experiencing] a shift in gender identity after initiating transition, or having stopped transition.”

Eighteen (64%) were assigned female sex at birth, and 10 (36%) were assigned male sex at birth. Twenty (71%) were aged 20-29; six were aged 30-39, and two were older than 40. Twenty-one were White. One participant who only socially transitioned was removed from the analysis of medical transitions. About half who medically transitioned did so between the ages of 18 and 24.

Reasons for stopping a medical transition included concerns about physical or mental health, surgical complications, postoperative pain, unsupportive parents or romantic partners, discrimination in the workplace, and difficulty accessing clinical care or gender-affirming surgery.

One participant, who had been assigned female sex at birth and who now identifies as female, said the transition did not help. The process was “a hot mess,” she said. Because she’d known people who had experienced improvements in mental and physical health as a result of transitioning, especially after initiating hormone therapy, she kept going. But, she said, “the farther I got into transition, the worse my [borderline personality disorder] symptoms and my presentation was.”
 

Lack of clinician support – going ‘cold turkey’

Many individuals reported that they stopped taking hormones “cold turkey,” without the support of a therapist or a clinician, because they did not trust health care providers or had had bad interactions with the medical system.

Most of those who had undergone gender-affirming surgical removal of testes or ovaries in their initial transition said the care they received when they decided to detransition was “bad.” Clinicians were judgmental or had inadequate knowledge about the process, the researchers reported. Some detransitioners said such encounters with clinicians added to their feelings of shame.

One participant who was born female and transitioned to male said she had good relationships with her clinicians and therapist, but she still felt “guilt and shame” about detransitioning back to female. She also worried that those clinicians would view her initial decision as a “mistake” or “through a lens of ‘regret,’ which was inauthentic to her feelings,” the researchers reported.

Another individual who had been assigned female sex at birth said that when she wanted to detransition, she consulted a physician about switching back to estrogen. “She wasn’t very tactful,” the person, who now identifies as female, recalled. “She made comments about how I should have thought about [my initial transition] harder.”

Participants said clinicians lacked sufficient information on detransitioning.

Dr. Turban noted that data are limited on the physiologic and psychological effects of discontinuing exogenous hormone therapy, “because it is such a rare occurrence.” He acknowledged that “more research is needed on the effects of discontinuation so that clinicians can better educate patients.”

The researchers found that most who sought to detransition consulted online forums and networks. The r/detrans discussion group on Reddit, for instance, now has 36,400 members.

Some reported regret that they had transitioned, while others – especially those who identify now as nonbinary or gender-fluid – said they were happy with their initial choice.

Eighteen of the 27 had no regrets and/or had positive feelings about the gender-affirming medications or procedures they had received in the past. Six (22%) had regret, and three were ambivalent. The rate of regret in the relatively small sample is higher than that observed in several other studies. Trans advocates also point out that detransitioning does not necessarily equate with regret.

When asked whether she regretted having undergone a double mastectomy, an individual who had been assigned female sex at birth and who now identifies as female said, “Some days I do, some days I don’t.” She also said she is not considering breast augmentation. “I’m just going to leave myself alone,” she said, adding that “it’s part of my journey.”

A participant who had been assigned female sex at birth and who now identifies as a cisgender woman said that she is mostly regarded by others as a trans person now, although she does not identify that way. But she said taking testosterone in the past was the right decision. “At the time, that was absolutely what I knew I had to do,” she said. “I’m actually not upset about any of the permanent changes it had on my body.”

The researchers noted that some participants said that “their parents or family circumstances explicitly forced, or implicitly encouraged detransition.”

Dr. Turban encouraged clinicians to consider how such external factors might “exacerbate internal factors,” such as internalized transphobia, which could lead to a discontinuation of gender-affirming care.

The study received funding from the Social Sciences and Humanities Research Council (SSHRC) Insight Development Program and a York University SSHRC Explore grant. Travis Salway, MD, a coauthor, has received grants from Canadian Institutes of Health Research, Michael Smith Health Research BC, BC SUPPORT Unit Fraser Centre, Simon Fraser University’s Community-Engaged Research Initiative, and the Social Sciences and Humanities Research Council outside the submitted work. The other authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

This article was been updated on 8/5/22 to include additional information about detransitioning.

Contemporary guidelines highly recommend patients with heart failure with reduced ejection fraction (HFrEF) be on all four drug classes that together have shown clinical clout, including improved survival, in major randomized trials.

Although many such patients don’t receive all four drug classes, the more that are prescribed to those with primary-prevention implantable defibrillators (ICD), the better their odds of survival, a new analysis suggests.

The cohort study of almost 5,000 patients with HFrEF and such devices saw their all-cause mortality risk improve stepwise with each additional prescription they were given toward the full quadruple drug combo at the core of modern HFrEF guideline-directed medical therapy (GDMT). The four classes are sodium-glucose cotransporter 2 inhibitors, beta-blockers, mineralocorticoid receptor antagonists (MRA), and renin-angiotensin system (RAS) inhibitors.

That inverse relation between risk and number of GDMT medications held whether patients had solo-ICD or defibrillating cardiac resynchronization therapy (CRT-D) implants, and were independent of device-implantation year and comorbidities, regardless of HFrEF etiology.

“If anybody had doubts about really pushing forward as much of these guideline-directed medical therapies as the patient tolerates, these data confirm that, by doing so, we definitely do better than with two medications or one medication,” Samir Saba, MD, University of Pittsburgh Medical Center, said in an interview.

The analysis begs an old and challenging question: Do primary-prevention ICDs confer clinically important survival gains over those provided by increasingly life-preserving recommended HFrEF medical therapy?

Given the study’s incremental survival bumps with each added GDMT med, “one ought to consider whether ICD therapy can still have an impact on overall survival in this population,” proposes a report published online in JACC Clinical Electrophysiology, with Dr. Saba as senior author.

In the adjusted analysis, the 2-year risk for death from any cause in HFrEF patients with primary-prevention devices fell 36% in those with ICDs and 30% in those with CRT-D devices for each added prescribed GDMT drug, from none up to either three or four such agents (P < .001 in both cases).

Only so much can be made of nonrandomized study results, Saba observed in an interview. But they are enough to justify asking whether primary-prevention ICDs are “still valuable” in HFrEF given current GDMT. One interpretation of the study, the published report noted, is that contemporary GDMT improves HFrEF survival so much that it eclipses any such benefit from a primary-prevention ICD.

Both defibrillators and the four core drug therapies boost survival in such cases, “so the fundamental question is, are they additive. Do we save more lives by having a defibrillator on top of the medications, or is it overlapping?” Dr. Saba asked. “We don’t know the answer.”

For now, at least, the findings could reassure clinicians as they consider whether to recommended a primary-prevention ICD when there might be reasons not to, as long there is full GDMT on board, “especially what we today define as quadruple guideline-directed medical therapy.”

Recently announced North American guidelines defining an HFrEF quadruple regimen prefer – beyond a beta-blocker, MRA, and SGLT2 inhibitor – that the selected RAS inhibitor be sacubitril/valsartan (Entresto, Novartis), with ACE inhibitors or angiotensin-receptor blockers (ARBs) as a substitute, if needed.  

Nearly identical European guidelines on HFrEF quad therapy, unveiled in 2021, include but do not necessarily prefer sacubitril/valsartan over ACE inhibitors as the RAS inhibitor of choice.
 

GDMT a moving target

Primary-prevention defibrillators entered practice at a time when expected background GDMT consisted of beta-blockers and either ACE inhibitors or ARBs, the current report notes. In practice, many patients receive the devices without both drug classes optimally on board. Moreover, many who otherwise meet guidelines for such ICDs won’t tolerate the kind of maximally tolerated GDMT used in the major primary-prevention device trials.

Yet current guidelines give such devices a class I recommendation, based on the highest level of evidence, in HFrEF patients who remain symptomatic despite quad GDMT, observed Gregg C. Fonarow, MD, University of California Los Angeles Medical Center.

The current analysis “further reinforces the importance of providing all four foundational GDMTs” to all eligible HFrEF patients without contraindications who can tolerate them, he said in an interview. Such quad therapy “is associated with incremental 1-year survival advantages” in patients with primary-prevention devices. And in the major trials, “there were reductions in sudden deaths, as well as progressive heart failure deaths.”

But the current study also suggests that in practice “very few patients can actually get to all four drugs on GDMT,” Roderick Tung, MD, University of Arizona, Phoenix, said in an interview. Optimized GDMT in randomized trials probably represents the best-case scenario. “There is a difference between randomized data and real-world data, which is why we need both.”

And it asserts that “the more GDMT you’re on, the better you do,” he said. “But does that obviate the need for an ICD? I think that’s not clear,” in part because of potential confounding in the analysis. For example, patients who can take all four agents tend to be less sick than those who cannot.

“The ones who can get up to four are preselected, because they’re healthier,” Dr. Tung said. “There are real limitations – such as metabolic disturbances, acute kidney injury and cardiorenal syndrome, and hypotension – that actually make it difficult to initiate and titrate these medications.”

Indeed, the major primary-prevention ICD trials usually excluded the sickest patients with the most comorbidities, Dr. Saba observed, which raises issues about their relevance to clinical practice. But his group’s study controlled for many potential confounders by adjusting for, among other things, Elixhauser comorbidity score, ejection fraction, type of cardiomyopathy, and year of device implantation.

“We tried to level the playing field that way, to see if – despite all of this adjustment – the incremental number of heart failure medicines stills make a difference,” Dr. Saba said. “And our results suggest that yes, they still do.”
 

GDMT coverage in the real world

The analysis of patients with HFrEF involved 3,210 with ICD-only implants and 1,762 with CRT-D devices for primary prevention at a major medical center from 2010 to 2021. Of the total, 5% had not been prescribed any of the four GDMT agents, 20% had been prescribed only one, 52% were prescribed two, and 23% were prescribed three or four. Only 113 patients had been prescribed SGLT2 inhibitors, which have only recently been indicated for HFrEF.

Adjusted hazard ratios for death from any cause at 2 years for each added GDMT drug (P < .001 in each case), were 0.64 (95% confidence interval, 0.56-0.74) for ICD recipients, 0.70 (95% CI, 0.58-0.86) for those with a CRT-D device, 0.70 (95% CI, 0.60-0.81) for those with ischemic cardiomyopathy, and 0.61 (95% CI, 0.51-0.73) for patients with nonischemic disease.

The results “raise questions rather than answers,” Dr. Saba said. “At some point, someone will need to take patients who are optimized on their heart failure medications and then randomize them to defibrillator versus no defibrillator to see whether there is still an additive impact.”

Current best evidence suggests that primary-prevention ICDs in patients with guideline-based indications confer benefits that far outweigh any risks. But if the major primary-prevention ICD trials were to be repeated in patients on contemporary quad-therapy GDMT, Dr. Tung said, “would the benefit of ICD be attenuated? I think most of us believe it likely would.”

Still, he said, a background of modern GDMT could potentially “optimize” such trials by attenuating mortality from heart failure progression and thereby expanding the proportion of deaths that are arrhythmic, “which the defibrillator can prevent.”

Dr. Saba discloses receiving research support from Boston Scientific and Abbott; and serving on advisory boards for Medtronic and Boston Scientific. The other authors reported no relevant relationships. Dr. Tung has disclosed receiving speaker fees from Abbott and Boston Scientific. Dr. Fonarow has reported receiving personal fees from Abbott, Amgen, AstraZeneca, Bayer, Cytokinetics, Edwards, Janssen, Medtronic, Merck, and Novartis.

A version of this article first appeared on Medscape.com.

Contemporary guidelines highly recommend patients with heart failure with reduced ejection fraction (HFrEF) be on all four drug classes that together have shown clinical clout, including improved survival, in major randomized trials.

Although many such patients don’t receive all four drug classes, the more that are prescribed to those with primary-prevention implantable defibrillators (ICD), the better their odds of survival, a new analysis suggests.

The cohort study of almost 5,000 patients with HFrEF and such devices saw their all-cause mortality risk improve stepwise with each additional prescription they were given toward the full quadruple drug combo at the core of modern HFrEF guideline-directed medical therapy (GDMT). The four classes are sodium-glucose cotransporter 2 inhibitors, beta-blockers, mineralocorticoid receptor antagonists (MRA), and renin-angiotensin system (RAS) inhibitors.

That inverse relation between risk and number of GDMT medications held whether patients had solo-ICD or defibrillating cardiac resynchronization therapy (CRT-D) implants, and were independent of device-implantation year and comorbidities, regardless of HFrEF etiology.

“If anybody had doubts about really pushing forward as much of these guideline-directed medical therapies as the patient tolerates, these data confirm that, by doing so, we definitely do better than with two medications or one medication,” Samir Saba, MD, University of Pittsburgh Medical Center, said in an interview.

The analysis begs an old and challenging question: Do primary-prevention ICDs confer clinically important survival gains over those provided by increasingly life-preserving recommended HFrEF medical therapy?

Given the study’s incremental survival bumps with each added GDMT med, “one ought to consider whether ICD therapy can still have an impact on overall survival in this population,” proposes a report published online in JACC Clinical Electrophysiology, with Dr. Saba as senior author.

In the adjusted analysis, the 2-year risk for death from any cause in HFrEF patients with primary-prevention devices fell 36% in those with ICDs and 30% in those with CRT-D devices for each added prescribed GDMT drug, from none up to either three or four such agents (P < .001 in both cases).

Only so much can be made of nonrandomized study results, Saba observed in an interview. But they are enough to justify asking whether primary-prevention ICDs are “still valuable” in HFrEF given current GDMT. One interpretation of the study, the published report noted, is that contemporary GDMT improves HFrEF survival so much that it eclipses any such benefit from a primary-prevention ICD.

Both defibrillators and the four core drug therapies boost survival in such cases, “so the fundamental question is, are they additive. Do we save more lives by having a defibrillator on top of the medications, or is it overlapping?” Dr. Saba asked. “We don’t know the answer.”

For now, at least, the findings could reassure clinicians as they consider whether to recommended a primary-prevention ICD when there might be reasons not to, as long there is full GDMT on board, “especially what we today define as quadruple guideline-directed medical therapy.”

Recently announced North American guidelines defining an HFrEF quadruple regimen prefer – beyond a beta-blocker, MRA, and SGLT2 inhibitor – that the selected RAS inhibitor be sacubitril/valsartan (Entresto, Novartis), with ACE inhibitors or angiotensin-receptor blockers (ARBs) as a substitute, if needed.  

Nearly identical European guidelines on HFrEF quad therapy, unveiled in 2021, include but do not necessarily prefer sacubitril/valsartan over ACE inhibitors as the RAS inhibitor of choice.
 

GDMT a moving target

Primary-prevention defibrillators entered practice at a time when expected background GDMT consisted of beta-blockers and either ACE inhibitors or ARBs, the current report notes. In practice, many patients receive the devices without both drug classes optimally on board. Moreover, many who otherwise meet guidelines for such ICDs won’t tolerate the kind of maximally tolerated GDMT used in the major primary-prevention device trials.

Yet current guidelines give such devices a class I recommendation, based on the highest level of evidence, in HFrEF patients who remain symptomatic despite quad GDMT, observed Gregg C. Fonarow, MD, University of California Los Angeles Medical Center.

The current analysis “further reinforces the importance of providing all four foundational GDMTs” to all eligible HFrEF patients without contraindications who can tolerate them, he said in an interview. Such quad therapy “is associated with incremental 1-year survival advantages” in patients with primary-prevention devices. And in the major trials, “there were reductions in sudden deaths, as well as progressive heart failure deaths.”

But the current study also suggests that in practice “very few patients can actually get to all four drugs on GDMT,” Roderick Tung, MD, University of Arizona, Phoenix, said in an interview. Optimized GDMT in randomized trials probably represents the best-case scenario. “There is a difference between randomized data and real-world data, which is why we need both.”

And it asserts that “the more GDMT you’re on, the better you do,” he said. “But does that obviate the need for an ICD? I think that’s not clear,” in part because of potential confounding in the analysis. For example, patients who can take all four agents tend to be less sick than those who cannot.

“The ones who can get up to four are preselected, because they’re healthier,” Dr. Tung said. “There are real limitations – such as metabolic disturbances, acute kidney injury and cardiorenal syndrome, and hypotension – that actually make it difficult to initiate and titrate these medications.”

Indeed, the major primary-prevention ICD trials usually excluded the sickest patients with the most comorbidities, Dr. Saba observed, which raises issues about their relevance to clinical practice. But his group’s study controlled for many potential confounders by adjusting for, among other things, Elixhauser comorbidity score, ejection fraction, type of cardiomyopathy, and year of device implantation.

“We tried to level the playing field that way, to see if – despite all of this adjustment – the incremental number of heart failure medicines stills make a difference,” Dr. Saba said. “And our results suggest that yes, they still do.”
 

GDMT coverage in the real world

The analysis of patients with HFrEF involved 3,210 with ICD-only implants and 1,762 with CRT-D devices for primary prevention at a major medical center from 2010 to 2021. Of the total, 5% had not been prescribed any of the four GDMT agents, 20% had been prescribed only one, 52% were prescribed two, and 23% were prescribed three or four. Only 113 patients had been prescribed SGLT2 inhibitors, which have only recently been indicated for HFrEF.

Adjusted hazard ratios for death from any cause at 2 years for each added GDMT drug (P < .001 in each case), were 0.64 (95% confidence interval, 0.56-0.74) for ICD recipients, 0.70 (95% CI, 0.58-0.86) for those with a CRT-D device, 0.70 (95% CI, 0.60-0.81) for those with ischemic cardiomyopathy, and 0.61 (95% CI, 0.51-0.73) for patients with nonischemic disease.

The results “raise questions rather than answers,” Dr. Saba said. “At some point, someone will need to take patients who are optimized on their heart failure medications and then randomize them to defibrillator versus no defibrillator to see whether there is still an additive impact.”

Current best evidence suggests that primary-prevention ICDs in patients with guideline-based indications confer benefits that far outweigh any risks. But if the major primary-prevention ICD trials were to be repeated in patients on contemporary quad-therapy GDMT, Dr. Tung said, “would the benefit of ICD be attenuated? I think most of us believe it likely would.”

Still, he said, a background of modern GDMT could potentially “optimize” such trials by attenuating mortality from heart failure progression and thereby expanding the proportion of deaths that are arrhythmic, “which the defibrillator can prevent.”

Dr. Saba discloses receiving research support from Boston Scientific and Abbott; and serving on advisory boards for Medtronic and Boston Scientific. The other authors reported no relevant relationships. Dr. Tung has disclosed receiving speaker fees from Abbott and Boston Scientific. Dr. Fonarow has reported receiving personal fees from Abbott, Amgen, AstraZeneca, Bayer, Cytokinetics, Edwards, Janssen, Medtronic, Merck, and Novartis.

A version of this article first appeared on Medscape.com.

Contemporary guidelines highly recommend patients with heart failure with reduced ejection fraction (HFrEF) be on all four drug classes that together have shown clinical clout, including improved survival, in major randomized trials.

Although many such patients don’t receive all four drug classes, the more that are prescribed to those with primary-prevention implantable defibrillators (ICD), the better their odds of survival, a new analysis suggests.

The cohort study of almost 5,000 patients with HFrEF and such devices saw their all-cause mortality risk improve stepwise with each additional prescription they were given toward the full quadruple drug combo at the core of modern HFrEF guideline-directed medical therapy (GDMT). The four classes are sodium-glucose cotransporter 2 inhibitors, beta-blockers, mineralocorticoid receptor antagonists (MRA), and renin-angiotensin system (RAS) inhibitors.

That inverse relation between risk and number of GDMT medications held whether patients had solo-ICD or defibrillating cardiac resynchronization therapy (CRT-D) implants, and were independent of device-implantation year and comorbidities, regardless of HFrEF etiology.

“If anybody had doubts about really pushing forward as much of these guideline-directed medical therapies as the patient tolerates, these data confirm that, by doing so, we definitely do better than with two medications or one medication,” Samir Saba, MD, University of Pittsburgh Medical Center, said in an interview.

The analysis begs an old and challenging question: Do primary-prevention ICDs confer clinically important survival gains over those provided by increasingly life-preserving recommended HFrEF medical therapy?

Given the study’s incremental survival bumps with each added GDMT med, “one ought to consider whether ICD therapy can still have an impact on overall survival in this population,” proposes a report published online in JACC Clinical Electrophysiology, with Dr. Saba as senior author.

In the adjusted analysis, the 2-year risk for death from any cause in HFrEF patients with primary-prevention devices fell 36% in those with ICDs and 30% in those with CRT-D devices for each added prescribed GDMT drug, from none up to either three or four such agents (P < .001 in both cases).

Only so much can be made of nonrandomized study results, Saba observed in an interview. But they are enough to justify asking whether primary-prevention ICDs are “still valuable” in HFrEF given current GDMT. One interpretation of the study, the published report noted, is that contemporary GDMT improves HFrEF survival so much that it eclipses any such benefit from a primary-prevention ICD.

Both defibrillators and the four core drug therapies boost survival in such cases, “so the fundamental question is, are they additive. Do we save more lives by having a defibrillator on top of the medications, or is it overlapping?” Dr. Saba asked. “We don’t know the answer.”

For now, at least, the findings could reassure clinicians as they consider whether to recommended a primary-prevention ICD when there might be reasons not to, as long there is full GDMT on board, “especially what we today define as quadruple guideline-directed medical therapy.”

Recently announced North American guidelines defining an HFrEF quadruple regimen prefer – beyond a beta-blocker, MRA, and SGLT2 inhibitor – that the selected RAS inhibitor be sacubitril/valsartan (Entresto, Novartis), with ACE inhibitors or angiotensin-receptor blockers (ARBs) as a substitute, if needed.  

Nearly identical European guidelines on HFrEF quad therapy, unveiled in 2021, include but do not necessarily prefer sacubitril/valsartan over ACE inhibitors as the RAS inhibitor of choice.
 

GDMT a moving target

Primary-prevention defibrillators entered practice at a time when expected background GDMT consisted of beta-blockers and either ACE inhibitors or ARBs, the current report notes. In practice, many patients receive the devices without both drug classes optimally on board. Moreover, many who otherwise meet guidelines for such ICDs won’t tolerate the kind of maximally tolerated GDMT used in the major primary-prevention device trials.

Yet current guidelines give such devices a class I recommendation, based on the highest level of evidence, in HFrEF patients who remain symptomatic despite quad GDMT, observed Gregg C. Fonarow, MD, University of California Los Angeles Medical Center.

The current analysis “further reinforces the importance of providing all four foundational GDMTs” to all eligible HFrEF patients without contraindications who can tolerate them, he said in an interview. Such quad therapy “is associated with incremental 1-year survival advantages” in patients with primary-prevention devices. And in the major trials, “there were reductions in sudden deaths, as well as progressive heart failure deaths.”

But the current study also suggests that in practice “very few patients can actually get to all four drugs on GDMT,” Roderick Tung, MD, University of Arizona, Phoenix, said in an interview. Optimized GDMT in randomized trials probably represents the best-case scenario. “There is a difference between randomized data and real-world data, which is why we need both.”

And it asserts that “the more GDMT you’re on, the better you do,” he said. “But does that obviate the need for an ICD? I think that’s not clear,” in part because of potential confounding in the analysis. For example, patients who can take all four agents tend to be less sick than those who cannot.

“The ones who can get up to four are preselected, because they’re healthier,” Dr. Tung said. “There are real limitations – such as metabolic disturbances, acute kidney injury and cardiorenal syndrome, and hypotension – that actually make it difficult to initiate and titrate these medications.”

Indeed, the major primary-prevention ICD trials usually excluded the sickest patients with the most comorbidities, Dr. Saba observed, which raises issues about their relevance to clinical practice. But his group’s study controlled for many potential confounders by adjusting for, among other things, Elixhauser comorbidity score, ejection fraction, type of cardiomyopathy, and year of device implantation.

“We tried to level the playing field that way, to see if – despite all of this adjustment – the incremental number of heart failure medicines stills make a difference,” Dr. Saba said. “And our results suggest that yes, they still do.”
 

GDMT coverage in the real world

The analysis of patients with HFrEF involved 3,210 with ICD-only implants and 1,762 with CRT-D devices for primary prevention at a major medical center from 2010 to 2021. Of the total, 5% had not been prescribed any of the four GDMT agents, 20% had been prescribed only one, 52% were prescribed two, and 23% were prescribed three or four. Only 113 patients had been prescribed SGLT2 inhibitors, which have only recently been indicated for HFrEF.

Adjusted hazard ratios for death from any cause at 2 years for each added GDMT drug (P < .001 in each case), were 0.64 (95% confidence interval, 0.56-0.74) for ICD recipients, 0.70 (95% CI, 0.58-0.86) for those with a CRT-D device, 0.70 (95% CI, 0.60-0.81) for those with ischemic cardiomyopathy, and 0.61 (95% CI, 0.51-0.73) for patients with nonischemic disease.

The results “raise questions rather than answers,” Dr. Saba said. “At some point, someone will need to take patients who are optimized on their heart failure medications and then randomize them to defibrillator versus no defibrillator to see whether there is still an additive impact.”

Current best evidence suggests that primary-prevention ICDs in patients with guideline-based indications confer benefits that far outweigh any risks. But if the major primary-prevention ICD trials were to be repeated in patients on contemporary quad-therapy GDMT, Dr. Tung said, “would the benefit of ICD be attenuated? I think most of us believe it likely would.”

Still, he said, a background of modern GDMT could potentially “optimize” such trials by attenuating mortality from heart failure progression and thereby expanding the proportion of deaths that are arrhythmic, “which the defibrillator can prevent.”

Dr. Saba discloses receiving research support from Boston Scientific and Abbott; and serving on advisory boards for Medtronic and Boston Scientific. The other authors reported no relevant relationships. Dr. Tung has disclosed receiving speaker fees from Abbott and Boston Scientific. Dr. Fonarow has reported receiving personal fees from Abbott, Amgen, AstraZeneca, Bayer, Cytokinetics, Edwards, Janssen, Medtronic, Merck, and Novartis.

A version of this article first appeared on Medscape.com.

For people with peripheral artery disease (PAD), even short walks can be exercises in excruciation.

But a new study published  in the Journal of the American Heart Association has found that patients who can push through the pain appear to reap significant benefits in ambulation, balance, and leg strength, which have been linked to increased longevity.

“You have to push yourself and get those uncomfortable symptoms, or else you probably won’t get gains,” said Mary McDermott, MD, professor of medicine at Northwestern University, Chicago, and the senior author of the study.

M. Alexander Otto/MDedge News

Walking for exercise is critical for people with lower-extremity PAD, Dr. McDermott said, but leg pain dissuades many people with the condition from doing so. She said her group hopes that showing the payoff of the “no pain, no gain” approach gives people with PAD the resolve to walk regularly, even when it’s hard.

The new study, a post hoc analysis of the LITE (Low-Intensity Exercise Intervention in PAD) trial, found that low-intensity exercise did not improve the symptoms of PAD but high-intensity exercise did.

Dr. McDermott and her colleagues compared 109 people with PAD who walked fast enough to cause discomfort versus 101 people who walked at a comfortable pace and 54 people who did not exercise at all. The average age was 69 years, 48% of participants were women, and 61% were Black.

Everyone in the exercise groups walked at home, with visits to a medical center early in the study to get exercise tips and then phone support from exercise coaches throughout the remainder of the study. Researchers encouraged those in the discomfort group to walk fast enough to cause significant pain in their legs, for up to 10 minutes or as long as they could. They then rested before walking again, ideally up to five times per day for 5 days per week.

At 6 months, people in the discomfort group were walking 0.056 m/sec faster than those in the comfort group during a 4-meter walking test (95% confidence interval [CI], 0.19-0.094 m/sec; P < .01), a gap that had grown by 12 months to 0.084 m/sec (95% CI, 0.049-0.120 m/sec; P <.01), according to the researchers. A statistically significant gap also emerged between the discomfort and nonexercising group at 6 months, but it eventually closed.

“It’s a question that people have asked for some time: Is it necessary to get that ischemic pain when you walk?” Dr. McDermott said. “This is the first well-powered clinical trial to provide a definitive answer on that, and the answer is that you do need that discomfort. It wasn’t even close.” Indeed, Dr. McDermott said, it’s possible that walking merely to the point of comfort and never pushing beyond it may harm people with PAD.

At the 6-month mark, the researchers found no statistical difference between the discomfort and comfort groups on a cumulative scale of usual walking speed, ability to rise from a chair, and ability to maintain balance in several positions. By 12 months, the two groups had diverged, with the discomfort group improving by almost 1 point on the scale, whereas the performance of the comfort group declined. No significant differences emerged between the discomfort and nonexercising groups, the researchers reported.

The investigators found, counterintuitively, that some people in the study who did not record exercising did as well as those in the discomfort group,

Dr. McDermott noted that the nonexercise group was smaller than the discomfort group, making firm comparisons between the two challenging to draw. In addition, people whose exercise was not recorded were not asked to take it easy whenever they walked, unlike those in the comfort group. As a result, she said, some people in this group may have walked vigorously.

Dr. McDermott emphasized that these benefits occurred at home rather than at medical centers that can be difficult for some people to visit regularly.

“It’s always good to have this kind of information for patients, to show them that it’s possible for them to continue to improve,” said Jonathan Ehrman, PhD, associate director of preventive cardiology at Henry Ford Medical Center, Detroit. Dr. Ehrman was not involved in this study but said that he is contemplating running a similar home-based study that would use video rather than telephone support for patients.

“There’s emerging data about walking speed being related to longevity and predicting better outcomes in cardiac surgeries,” Dr. Ehrman said. “It seems to be, if you can get people walking faster or they have a better walking pace, related to better health outcomes.”

Dr. McDermott reported relationships with Regeneron, Helixmith, Mars, ArtAssist, ReserveAge, and Hershey. Dr. Ehrman reported no relevant financial conflicts of interest.

A version of this article first appeared on Medscape.com.

For people with peripheral artery disease (PAD), even short walks can be exercises in excruciation.

But a new study published  in the Journal of the American Heart Association has found that patients who can push through the pain appear to reap significant benefits in ambulation, balance, and leg strength, which have been linked to increased longevity.

“You have to push yourself and get those uncomfortable symptoms, or else you probably won’t get gains,” said Mary McDermott, MD, professor of medicine at Northwestern University, Chicago, and the senior author of the study.

M. Alexander Otto/MDedge News

Walking for exercise is critical for people with lower-extremity PAD, Dr. McDermott said, but leg pain dissuades many people with the condition from doing so. She said her group hopes that showing the payoff of the “no pain, no gain” approach gives people with PAD the resolve to walk regularly, even when it’s hard.

The new study, a post hoc analysis of the LITE (Low-Intensity Exercise Intervention in PAD) trial, found that low-intensity exercise did not improve the symptoms of PAD but high-intensity exercise did.

Dr. McDermott and her colleagues compared 109 people with PAD who walked fast enough to cause discomfort versus 101 people who walked at a comfortable pace and 54 people who did not exercise at all. The average age was 69 years, 48% of participants were women, and 61% were Black.

Everyone in the exercise groups walked at home, with visits to a medical center early in the study to get exercise tips and then phone support from exercise coaches throughout the remainder of the study. Researchers encouraged those in the discomfort group to walk fast enough to cause significant pain in their legs, for up to 10 minutes or as long as they could. They then rested before walking again, ideally up to five times per day for 5 days per week.

At 6 months, people in the discomfort group were walking 0.056 m/sec faster than those in the comfort group during a 4-meter walking test (95% confidence interval [CI], 0.19-0.094 m/sec; P < .01), a gap that had grown by 12 months to 0.084 m/sec (95% CI, 0.049-0.120 m/sec; P <.01), according to the researchers. A statistically significant gap also emerged between the discomfort and nonexercising group at 6 months, but it eventually closed.

“It’s a question that people have asked for some time: Is it necessary to get that ischemic pain when you walk?” Dr. McDermott said. “This is the first well-powered clinical trial to provide a definitive answer on that, and the answer is that you do need that discomfort. It wasn’t even close.” Indeed, Dr. McDermott said, it’s possible that walking merely to the point of comfort and never pushing beyond it may harm people with PAD.

At the 6-month mark, the researchers found no statistical difference between the discomfort and comfort groups on a cumulative scale of usual walking speed, ability to rise from a chair, and ability to maintain balance in several positions. By 12 months, the two groups had diverged, with the discomfort group improving by almost 1 point on the scale, whereas the performance of the comfort group declined. No significant differences emerged between the discomfort and nonexercising groups, the researchers reported.

The investigators found, counterintuitively, that some people in the study who did not record exercising did as well as those in the discomfort group,

Dr. McDermott noted that the nonexercise group was smaller than the discomfort group, making firm comparisons between the two challenging to draw. In addition, people whose exercise was not recorded were not asked to take it easy whenever they walked, unlike those in the comfort group. As a result, she said, some people in this group may have walked vigorously.

Dr. McDermott emphasized that these benefits occurred at home rather than at medical centers that can be difficult for some people to visit regularly.

“It’s always good to have this kind of information for patients, to show them that it’s possible for them to continue to improve,” said Jonathan Ehrman, PhD, associate director of preventive cardiology at Henry Ford Medical Center, Detroit. Dr. Ehrman was not involved in this study but said that he is contemplating running a similar home-based study that would use video rather than telephone support for patients.

“There’s emerging data about walking speed being related to longevity and predicting better outcomes in cardiac surgeries,” Dr. Ehrman said. “It seems to be, if you can get people walking faster or they have a better walking pace, related to better health outcomes.”

Dr. McDermott reported relationships with Regeneron, Helixmith, Mars, ArtAssist, ReserveAge, and Hershey. Dr. Ehrman reported no relevant financial conflicts of interest.

A version of this article first appeared on Medscape.com.

For people with peripheral artery disease (PAD), even short walks can be exercises in excruciation.

But a new study published  in the Journal of the American Heart Association has found that patients who can push through the pain appear to reap significant benefits in ambulation, balance, and leg strength, which have been linked to increased longevity.

“You have to push yourself and get those uncomfortable symptoms, or else you probably won’t get gains,” said Mary McDermott, MD, professor of medicine at Northwestern University, Chicago, and the senior author of the study.

M. Alexander Otto/MDedge News

Walking for exercise is critical for people with lower-extremity PAD, Dr. McDermott said, but leg pain dissuades many people with the condition from doing so. She said her group hopes that showing the payoff of the “no pain, no gain” approach gives people with PAD the resolve to walk regularly, even when it’s hard.

The new study, a post hoc analysis of the LITE (Low-Intensity Exercise Intervention in PAD) trial, found that low-intensity exercise did not improve the symptoms of PAD but high-intensity exercise did.

Dr. McDermott and her colleagues compared 109 people with PAD who walked fast enough to cause discomfort versus 101 people who walked at a comfortable pace and 54 people who did not exercise at all. The average age was 69 years, 48% of participants were women, and 61% were Black.

Everyone in the exercise groups walked at home, with visits to a medical center early in the study to get exercise tips and then phone support from exercise coaches throughout the remainder of the study. Researchers encouraged those in the discomfort group to walk fast enough to cause significant pain in their legs, for up to 10 minutes or as long as they could. They then rested before walking again, ideally up to five times per day for 5 days per week.

At 6 months, people in the discomfort group were walking 0.056 m/sec faster than those in the comfort group during a 4-meter walking test (95% confidence interval [CI], 0.19-0.094 m/sec; P < .01), a gap that had grown by 12 months to 0.084 m/sec (95% CI, 0.049-0.120 m/sec; P <.01), according to the researchers. A statistically significant gap also emerged between the discomfort and nonexercising group at 6 months, but it eventually closed.

“It’s a question that people have asked for some time: Is it necessary to get that ischemic pain when you walk?” Dr. McDermott said. “This is the first well-powered clinical trial to provide a definitive answer on that, and the answer is that you do need that discomfort. It wasn’t even close.” Indeed, Dr. McDermott said, it’s possible that walking merely to the point of comfort and never pushing beyond it may harm people with PAD.

At the 6-month mark, the researchers found no statistical difference between the discomfort and comfort groups on a cumulative scale of usual walking speed, ability to rise from a chair, and ability to maintain balance in several positions. By 12 months, the two groups had diverged, with the discomfort group improving by almost 1 point on the scale, whereas the performance of the comfort group declined. No significant differences emerged between the discomfort and nonexercising groups, the researchers reported.

The investigators found, counterintuitively, that some people in the study who did not record exercising did as well as those in the discomfort group,

Dr. McDermott noted that the nonexercise group was smaller than the discomfort group, making firm comparisons between the two challenging to draw. In addition, people whose exercise was not recorded were not asked to take it easy whenever they walked, unlike those in the comfort group. As a result, she said, some people in this group may have walked vigorously.

Dr. McDermott emphasized that these benefits occurred at home rather than at medical centers that can be difficult for some people to visit regularly.

“It’s always good to have this kind of information for patients, to show them that it’s possible for them to continue to improve,” said Jonathan Ehrman, PhD, associate director of preventive cardiology at Henry Ford Medical Center, Detroit. Dr. Ehrman was not involved in this study but said that he is contemplating running a similar home-based study that would use video rather than telephone support for patients.

“There’s emerging data about walking speed being related to longevity and predicting better outcomes in cardiac surgeries,” Dr. Ehrman said. “It seems to be, if you can get people walking faster or they have a better walking pace, related to better health outcomes.”

Dr. McDermott reported relationships with Regeneron, Helixmith, Mars, ArtAssist, ReserveAge, and Hershey. Dr. Ehrman reported no relevant financial conflicts of interest.

A version of this article first appeared on Medscape.com.

INDIANAPOLIS – If there’s one truth that David R. Stukus, MD, has come to realize from his 2 years as director of a food allergy treatment center, it’s that food allergies in children and adolescents are grossly overdiagnosed and misdiagnosed.

“When they’re given a diagnosis of food allergy, many families do not receive proper education to help them understand the risk as well as self-management and prognosis,” he said at the annual meeting of the Society for Pediatric Dermatology. “They are left to fend for themselves, which leads to increased anxiety. If they don’t understand what it means to manage their child’s food allergy, they’re going to think that they’re a ticking time bomb,” said Dr. Stukus, director of the Food Allergy Treatment Center and professor of pediatrics in the division of allergy and immunology at Nationwide Children’s Hospital in Columbus, Ohio.

During his presentation, he toured clinicians through best practices to diagnose and treat food allergies and shared cautionary tales of unsupported claims, unnecessary testing, and potential harm to misdiagnosed patients.

While food allergies can be serious and life-threatening, they are also manageable, he continued. It doesn’t mean that children with food allergies can’t go to school, attend baseball games, or participate in activities that any other child would. “Telling someone to adopt a restricted diet is not a benign recommendation,” he said. “That can cause real harm.”

Dr. Stukus defined food allergy as an immunologic response to an allergen that results in reproducible symptoms with every exposure. “Most commonly we’re going to see IgE-mediated food allergies, which often occur within minutes of eating certain foods,” he said.

Food intolerance, on the other hand, is a nonimmunologic response to a food that causes gastrointestinal symptoms with exposure. “This can come and go over time,” he said. “The most common example is lactose intolerance.”

Then there’s food sensitivity, which Dr. Stukus said is not a medical term but a marketing term often applied to a variety of symptoms without evidence to support its use.

“On the Internet you will find many companies marketing food sensitivity tests,” he said. “Gluten-free foods are now a billion-dollar industry. There are no validated tests to diagnose food sensitivity. All the blood tests measure IgG, which is memory antibody. If you eat a food, it is a normal response to produce IgG to it, but these companies will test all these things and when it comes back elevated, they say ‘Aha! This is your food sensitivity and this is why you’re not sleeping well at night.’ ” To illustrate the harm that can come from food allergy tests he discussed a 6-year-old girl who presented to his clinic several years ago with typical symptoms of allergic rhinitis. The parent reported a history of sneezing around dogs, itchy, watery eyes in the spring, recurrent cough, and frequent upper respiratory infections.

The referring physician had ordered an allergy panel, which flagged a long list of foods that the girl was supposedly allergic to, including banana, egg white, cod, and peanut. “This family was told to take all of these foods out of her diet,” Dr. Stukus said. “Interestingly, she had been seen by this physician for evaluation of environmental allergies, but the only ones included in the test were cat, cockroach, dog, and dust mite. They didn’t even include the spring pollen allergies. You want to avoid tests like this.”

Food sensitization is not the same as food allergy, he continued, noting that about 30% of all children will have detectable IgE toward peanuts, milk, egg, and shrimp, but that only about 5% are truly allergic to those foods.

“If we go by IgE testing alone, we’re going to overdiagnose the vast majority of people with food allergies that they don’t actually have,” he said. “Food allergy is diagnosed by the history and then confirmed by testing. With IgE-mediated food allergies we know that milk, egg, wheat, soy, finned fish, shellfish, and peanuts account for more than 90% of all food allergy reactions. Can any food potentially cause a food allergy? Yes, potentially, but we know that most fruits and vegetables and grains are very unlikely to cause an allergy.”

IgE-mediated food allergies are objective, immediate onset, and reproducible with every exposure to the offending food, no matter what form. Typical symptoms include hives, swelling, vomiting, runny nose/congestion, wheezing, hypotension, and anaphylaxis.

“We can also accurately identify infants that are more at risk to develop food allergies,” Dr. Stukus said. Infants with refractory atopic dermatitis often progress from eczema to food allergies to allergic rhinitis and asthma, the so-called “allergic march.” “Family history does have a role as well, but it’s not as significant,” he said. As for diagnostic tools, skin prick testing detects the presence of specific IgE bound to cutaneous mast cells and has a high negative predictive value and a low positive predictive value (around 50%).

With serum-specific IgE testing, levels of IgE for food and/or inhalant allergen can be obtained conveniently through routine venipuncture. Results are reported in ranges from 0.1 kU/L to 100 kU/L, and some are reported as arbitrary classes in levels of severity from 1 to 5.

“I highly discourage anybody from paying attention to arbitrary classes [on these reports],” Dr. Stukus said. “Those are meaningless. The absolute value is all that matters.”

He added that both skin and blood testing have high rates of false positive results. “We really need to use the history to help guide what tests we do; they were never designed to be used as screening tests, yet they’re used as screening tests on a regular basis,” he said. “There is also no indication to do shotgun testing. The reason why is because we see lots of cross reactivity on testing. If we have someone with peanut allergy and we start doing specific IgE testing for all legumes, more often than not we’re going to find detectable IgE, but it’s much less likely that they actually have clinical reactivity to foods like soy and beans.”

Dr. Stukus advises clinicians to consider certain questions before they order an allergen panel, the first being: Do I have the knowledge and experience to properly interpret the results?

“If you don’t know how to interpret the test, you probably shouldn’t order it in the first place,” he said. “If you do have the knowledge to interpret the results, will the results help to determine the diagnosis or change management? If not, why are you testing just to test? There is zero clinical indication to order a food allergy panel.” Dr. Stukus recommended a review of unproven tests for adverse reactions to foods published in 2018 in The Journal of Allergy and Clinical Immunology.

According to Dr. Stukus, potential harms from unproven food allergy tests include cost, unnecessary dietary avoidance, and a delay in diagnosis for the underlying condition. During the COVID-19 pandemic, he observed an increase in the number of patients with orthorexia, which he described as an eating disorder characterized by having an unsafe obsession with healthy food that becomes deeply rooted in the individual’s way of thinking to the point that it interferes with daily life.

“If you take someone who has anxiety at baseline, and then you give them a list of foods that they allegedly can’t eat, that’s going to cause worse anxiety,” he added. “We’re seeing that from the results of these tests.”

Dr. Stukus disclosed that he is a consultant for Before Brands, Kaleo, and Novartis. He is also associate editor of the Annals of Allergy, Asthma and Immunology.

INDIANAPOLIS – If there’s one truth that David R. Stukus, MD, has come to realize from his 2 years as director of a food allergy treatment center, it’s that food allergies in children and adolescents are grossly overdiagnosed and misdiagnosed.

“When they’re given a diagnosis of food allergy, many families do not receive proper education to help them understand the risk as well as self-management and prognosis,” he said at the annual meeting of the Society for Pediatric Dermatology. “They are left to fend for themselves, which leads to increased anxiety. If they don’t understand what it means to manage their child’s food allergy, they’re going to think that they’re a ticking time bomb,” said Dr. Stukus, director of the Food Allergy Treatment Center and professor of pediatrics in the division of allergy and immunology at Nationwide Children’s Hospital in Columbus, Ohio.

During his presentation, he toured clinicians through best practices to diagnose and treat food allergies and shared cautionary tales of unsupported claims, unnecessary testing, and potential harm to misdiagnosed patients.

While food allergies can be serious and life-threatening, they are also manageable, he continued. It doesn’t mean that children with food allergies can’t go to school, attend baseball games, or participate in activities that any other child would. “Telling someone to adopt a restricted diet is not a benign recommendation,” he said. “That can cause real harm.”

Dr. Stukus defined food allergy as an immunologic response to an allergen that results in reproducible symptoms with every exposure. “Most commonly we’re going to see IgE-mediated food allergies, which often occur within minutes of eating certain foods,” he said.

Food intolerance, on the other hand, is a nonimmunologic response to a food that causes gastrointestinal symptoms with exposure. “This can come and go over time,” he said. “The most common example is lactose intolerance.”

Then there’s food sensitivity, which Dr. Stukus said is not a medical term but a marketing term often applied to a variety of symptoms without evidence to support its use.

“On the Internet you will find many companies marketing food sensitivity tests,” he said. “Gluten-free foods are now a billion-dollar industry. There are no validated tests to diagnose food sensitivity. All the blood tests measure IgG, which is memory antibody. If you eat a food, it is a normal response to produce IgG to it, but these companies will test all these things and when it comes back elevated, they say ‘Aha! This is your food sensitivity and this is why you’re not sleeping well at night.’ ” To illustrate the harm that can come from food allergy tests he discussed a 6-year-old girl who presented to his clinic several years ago with typical symptoms of allergic rhinitis. The parent reported a history of sneezing around dogs, itchy, watery eyes in the spring, recurrent cough, and frequent upper respiratory infections.

The referring physician had ordered an allergy panel, which flagged a long list of foods that the girl was supposedly allergic to, including banana, egg white, cod, and peanut. “This family was told to take all of these foods out of her diet,” Dr. Stukus said. “Interestingly, she had been seen by this physician for evaluation of environmental allergies, but the only ones included in the test were cat, cockroach, dog, and dust mite. They didn’t even include the spring pollen allergies. You want to avoid tests like this.”

Food sensitization is not the same as food allergy, he continued, noting that about 30% of all children will have detectable IgE toward peanuts, milk, egg, and shrimp, but that only about 5% are truly allergic to those foods.

“If we go by IgE testing alone, we’re going to overdiagnose the vast majority of people with food allergies that they don’t actually have,” he said. “Food allergy is diagnosed by the history and then confirmed by testing. With IgE-mediated food allergies we know that milk, egg, wheat, soy, finned fish, shellfish, and peanuts account for more than 90% of all food allergy reactions. Can any food potentially cause a food allergy? Yes, potentially, but we know that most fruits and vegetables and grains are very unlikely to cause an allergy.”

IgE-mediated food allergies are objective, immediate onset, and reproducible with every exposure to the offending food, no matter what form. Typical symptoms include hives, swelling, vomiting, runny nose/congestion, wheezing, hypotension, and anaphylaxis.

“We can also accurately identify infants that are more at risk to develop food allergies,” Dr. Stukus said. Infants with refractory atopic dermatitis often progress from eczema to food allergies to allergic rhinitis and asthma, the so-called “allergic march.” “Family history does have a role as well, but it’s not as significant,” he said. As for diagnostic tools, skin prick testing detects the presence of specific IgE bound to cutaneous mast cells and has a high negative predictive value and a low positive predictive value (around 50%).

With serum-specific IgE testing, levels of IgE for food and/or inhalant allergen can be obtained conveniently through routine venipuncture. Results are reported in ranges from 0.1 kU/L to 100 kU/L, and some are reported as arbitrary classes in levels of severity from 1 to 5.

“I highly discourage anybody from paying attention to arbitrary classes [on these reports],” Dr. Stukus said. “Those are meaningless. The absolute value is all that matters.”

He added that both skin and blood testing have high rates of false positive results. “We really need to use the history to help guide what tests we do; they were never designed to be used as screening tests, yet they’re used as screening tests on a regular basis,” he said. “There is also no indication to do shotgun testing. The reason why is because we see lots of cross reactivity on testing. If we have someone with peanut allergy and we start doing specific IgE testing for all legumes, more often than not we’re going to find detectable IgE, but it’s much less likely that they actually have clinical reactivity to foods like soy and beans.”

Dr. Stukus advises clinicians to consider certain questions before they order an allergen panel, the first being: Do I have the knowledge and experience to properly interpret the results?

“If you don’t know how to interpret the test, you probably shouldn’t order it in the first place,” he said. “If you do have the knowledge to interpret the results, will the results help to determine the diagnosis or change management? If not, why are you testing just to test? There is zero clinical indication to order a food allergy panel.” Dr. Stukus recommended a review of unproven tests for adverse reactions to foods published in 2018 in The Journal of Allergy and Clinical Immunology.

According to Dr. Stukus, potential harms from unproven food allergy tests include cost, unnecessary dietary avoidance, and a delay in diagnosis for the underlying condition. During the COVID-19 pandemic, he observed an increase in the number of patients with orthorexia, which he described as an eating disorder characterized by having an unsafe obsession with healthy food that becomes deeply rooted in the individual’s way of thinking to the point that it interferes with daily life.

“If you take someone who has anxiety at baseline, and then you give them a list of foods that they allegedly can’t eat, that’s going to cause worse anxiety,” he added. “We’re seeing that from the results of these tests.”

Dr. Stukus disclosed that he is a consultant for Before Brands, Kaleo, and Novartis. He is also associate editor of the Annals of Allergy, Asthma and Immunology.

INDIANAPOLIS – If there’s one truth that David R. Stukus, MD, has come to realize from his 2 years as director of a food allergy treatment center, it’s that food allergies in children and adolescents are grossly overdiagnosed and misdiagnosed.

“When they’re given a diagnosis of food allergy, many families do not receive proper education to help them understand the risk as well as self-management and prognosis,” he said at the annual meeting of the Society for Pediatric Dermatology. “They are left to fend for themselves, which leads to increased anxiety. If they don’t understand what it means to manage their child’s food allergy, they’re going to think that they’re a ticking time bomb,” said Dr. Stukus, director of the Food Allergy Treatment Center and professor of pediatrics in the division of allergy and immunology at Nationwide Children’s Hospital in Columbus, Ohio.

During his presentation, he toured clinicians through best practices to diagnose and treat food allergies and shared cautionary tales of unsupported claims, unnecessary testing, and potential harm to misdiagnosed patients.

While food allergies can be serious and life-threatening, they are also manageable, he continued. It doesn’t mean that children with food allergies can’t go to school, attend baseball games, or participate in activities that any other child would. “Telling someone to adopt a restricted diet is not a benign recommendation,” he said. “That can cause real harm.”

Dr. Stukus defined food allergy as an immunologic response to an allergen that results in reproducible symptoms with every exposure. “Most commonly we’re going to see IgE-mediated food allergies, which often occur within minutes of eating certain foods,” he said.

Food intolerance, on the other hand, is a nonimmunologic response to a food that causes gastrointestinal symptoms with exposure. “This can come and go over time,” he said. “The most common example is lactose intolerance.”

Then there’s food sensitivity, which Dr. Stukus said is not a medical term but a marketing term often applied to a variety of symptoms without evidence to support its use.

“On the Internet you will find many companies marketing food sensitivity tests,” he said. “Gluten-free foods are now a billion-dollar industry. There are no validated tests to diagnose food sensitivity. All the blood tests measure IgG, which is memory antibody. If you eat a food, it is a normal response to produce IgG to it, but these companies will test all these things and when it comes back elevated, they say ‘Aha! This is your food sensitivity and this is why you’re not sleeping well at night.’ ” To illustrate the harm that can come from food allergy tests he discussed a 6-year-old girl who presented to his clinic several years ago with typical symptoms of allergic rhinitis. The parent reported a history of sneezing around dogs, itchy, watery eyes in the spring, recurrent cough, and frequent upper respiratory infections.

The referring physician had ordered an allergy panel, which flagged a long list of foods that the girl was supposedly allergic to, including banana, egg white, cod, and peanut. “This family was told to take all of these foods out of her diet,” Dr. Stukus said. “Interestingly, she had been seen by this physician for evaluation of environmental allergies, but the only ones included in the test were cat, cockroach, dog, and dust mite. They didn’t even include the spring pollen allergies. You want to avoid tests like this.”

Food sensitization is not the same as food allergy, he continued, noting that about 30% of all children will have detectable IgE toward peanuts, milk, egg, and shrimp, but that only about 5% are truly allergic to those foods.

“If we go by IgE testing alone, we’re going to overdiagnose the vast majority of people with food allergies that they don’t actually have,” he said. “Food allergy is diagnosed by the history and then confirmed by testing. With IgE-mediated food allergies we know that milk, egg, wheat, soy, finned fish, shellfish, and peanuts account for more than 90% of all food allergy reactions. Can any food potentially cause a food allergy? Yes, potentially, but we know that most fruits and vegetables and grains are very unlikely to cause an allergy.”

IgE-mediated food allergies are objective, immediate onset, and reproducible with every exposure to the offending food, no matter what form. Typical symptoms include hives, swelling, vomiting, runny nose/congestion, wheezing, hypotension, and anaphylaxis.

“We can also accurately identify infants that are more at risk to develop food allergies,” Dr. Stukus said. Infants with refractory atopic dermatitis often progress from eczema to food allergies to allergic rhinitis and asthma, the so-called “allergic march.” “Family history does have a role as well, but it’s not as significant,” he said. As for diagnostic tools, skin prick testing detects the presence of specific IgE bound to cutaneous mast cells and has a high negative predictive value and a low positive predictive value (around 50%).

With serum-specific IgE testing, levels of IgE for food and/or inhalant allergen can be obtained conveniently through routine venipuncture. Results are reported in ranges from 0.1 kU/L to 100 kU/L, and some are reported as arbitrary classes in levels of severity from 1 to 5.

“I highly discourage anybody from paying attention to arbitrary classes [on these reports],” Dr. Stukus said. “Those are meaningless. The absolute value is all that matters.”

He added that both skin and blood testing have high rates of false positive results. “We really need to use the history to help guide what tests we do; they were never designed to be used as screening tests, yet they’re used as screening tests on a regular basis,” he said. “There is also no indication to do shotgun testing. The reason why is because we see lots of cross reactivity on testing. If we have someone with peanut allergy and we start doing specific IgE testing for all legumes, more often than not we’re going to find detectable IgE, but it’s much less likely that they actually have clinical reactivity to foods like soy and beans.”

Dr. Stukus advises clinicians to consider certain questions before they order an allergen panel, the first being: Do I have the knowledge and experience to properly interpret the results?

“If you don’t know how to interpret the test, you probably shouldn’t order it in the first place,” he said. “If you do have the knowledge to interpret the results, will the results help to determine the diagnosis or change management? If not, why are you testing just to test? There is zero clinical indication to order a food allergy panel.” Dr. Stukus recommended a review of unproven tests for adverse reactions to foods published in 2018 in The Journal of Allergy and Clinical Immunology.

According to Dr. Stukus, potential harms from unproven food allergy tests include cost, unnecessary dietary avoidance, and a delay in diagnosis for the underlying condition. During the COVID-19 pandemic, he observed an increase in the number of patients with orthorexia, which he described as an eating disorder characterized by having an unsafe obsession with healthy food that becomes deeply rooted in the individual’s way of thinking to the point that it interferes with daily life.

“If you take someone who has anxiety at baseline, and then you give them a list of foods that they allegedly can’t eat, that’s going to cause worse anxiety,” he added. “We’re seeing that from the results of these tests.”

Dr. Stukus disclosed that he is a consultant for Before Brands, Kaleo, and Novartis. He is also associate editor of the Annals of Allergy, Asthma and Immunology.

Cardiovascular disease (CVD) mortality rose significantly during the COVID-19 pandemic and persists more than 2 years on and, once again, Blacks and African Americans have been disproportionately affected, an analysis of death certificates shows.

The findings “suggest that the pandemic may reverse years or decades of work aimed at reducing gaps in cardiovascular outcomes,” Sadeer G. Al-Kindi, MD, Case Western Reserve University, Cleveland, said in an interview.

Although the disparities are in line with previous research, he said, “what was surprising is the persistence of excess cardiovascular mortality approximately 2 years after the pandemic started, even during a period of low COVID-19 mortality.”

“This suggests that the pandemic resulted in a disruption of health care access and, along with disparities in COVID-19 infection and its complications, he said, “may have a long-lasting effect on health care disparities, especially among vulnerable populations.”

The study was published online in Mayo Clinic Proceedings with lead author Scott E. Janus, MD, also of Case Western Reserve University.
 

Impact consistently greater for Blacks

Dr. Al-Kindi and colleagues used 3,598,352 U.S. death files to investigate trends in deaths caused specifically by CVD as well as its subtypes myocardial infarction, stroke, and heart failure (HF) in 2018 and 2019 (prepandemic) and the pandemic years 2020 and 2021. Baseline demographics showed a higher percentage of older, female, and Black individuals among the CVD subtypes of interest.

Overall, there was an excess CVD mortality of 6.7% during the pandemic, compared with prepandemic years, including a 2.5% rise in MI deaths and an 8.5% rise in stroke deaths. HF mortality remained relatively steady, rising only 0.1%.

Subgroup analyses revealed “striking differences” in excess mortality between Blacks and Whites, the authors noted. Blacks had an overall excess mortality of 13.8% versus 5.1% for Whites, compared with the prepandemic years. The differences were consistent across subtypes: MI (9.6% vs. 1.0%); stroke (14.5% vs. 6.9%); and HF (5.1% vs. –1.2%; P value for all < .001).

When the investigators looked at deaths on a yearly basis with 2018 as the baseline, they found CVD deaths increased by 1.5% in 2019, 15.8% in 2020, and 13.5% in 2021 among Black Americans, compared with 0.5%, 5.1%, and 5.7%, respectively, among White Americans.

Excess deaths from MI rose by 9.5% in 2020 and by 6.7% in 2021 among Blacks but fell by 1.2% in 2020 and by 1.0% in 2021 among Whites.

Disparities in excess HF mortality were similar, rising 9.1% and 4.1% in 2020 and 2021 among Blacks, while dipping 0.1% and 0.8% in 2020 and 2021 among Whites.

The “most striking difference” was in excess stroke mortality, which doubled among Blacks compared with whites in 2020 (14.9% vs. 6.7%) and in 2021 (17.5% vs. 8.1%), according to the authors.
 

Awareness urged

Although the disparities were expected, “there is clear value in documenting and quantifying the magnitude of these disparities,” Amil M. Shah, MD, MPH, of Harvard Medical School and Brigham and Women’s Hospital, both in Boston, said in an interview.

In addition to being observational, the main limitation of the study, he noted, is the quality and resolution of the death certificate data, which may limit the accuracy of the cause of death ascertainment and classification of race or ethnicity. “However, I think these potential inaccuracies are unlikely to materially impact the overall study findings.”

Dr. Shah, who was not involved in the study, said he would like to see additional research into the diversity and heterogeneity in risk among Black communities. “Understanding the environmental, social, and health care factors – both harmful and protective – that influence risk for CVD morbidity and mortality among Black individuals and communities offers the promise to provide actionable insights to mitigate these disparities.”

“Intervention studies testing approaches to mitigate disparities based on race/ethnicity” are also needed, he added. These may be at the policy, community, health system, or individual level, and community involvement in phases will be essential.”

Meanwhile, both Dr. Al-Kindi and Dr. Shah urged clinicians to be aware of the disparities and the need to improve access to care and address social determinants of health in vulnerable populations.

These disparities “are driven by structural factors, and are reinforced by individual behaviors. In this context, implicit bias training is important to help clinicians recognize and mitigate bias in their own practice,” Dr. Shah said. “Supporting diversity, equity, and inclusion efforts, and advocating for anti-racist policies and practices in their health systems” can also help.

Dr. Al-Kindi and Dr. Shah disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Cardiovascular disease (CVD) mortality rose significantly during the COVID-19 pandemic and persists more than 2 years on and, once again, Blacks and African Americans have been disproportionately affected, an analysis of death certificates shows.

The findings “suggest that the pandemic may reverse years or decades of work aimed at reducing gaps in cardiovascular outcomes,” Sadeer G. Al-Kindi, MD, Case Western Reserve University, Cleveland, said in an interview.

Although the disparities are in line with previous research, he said, “what was surprising is the persistence of excess cardiovascular mortality approximately 2 years after the pandemic started, even during a period of low COVID-19 mortality.”

“This suggests that the pandemic resulted in a disruption of health care access and, along with disparities in COVID-19 infection and its complications, he said, “may have a long-lasting effect on health care disparities, especially among vulnerable populations.”

The study was published online in Mayo Clinic Proceedings with lead author Scott E. Janus, MD, also of Case Western Reserve University.
 

Impact consistently greater for Blacks

Dr. Al-Kindi and colleagues used 3,598,352 U.S. death files to investigate trends in deaths caused specifically by CVD as well as its subtypes myocardial infarction, stroke, and heart failure (HF) in 2018 and 2019 (prepandemic) and the pandemic years 2020 and 2021. Baseline demographics showed a higher percentage of older, female, and Black individuals among the CVD subtypes of interest.

Overall, there was an excess CVD mortality of 6.7% during the pandemic, compared with prepandemic years, including a 2.5% rise in MI deaths and an 8.5% rise in stroke deaths. HF mortality remained relatively steady, rising only 0.1%.

Subgroup analyses revealed “striking differences” in excess mortality between Blacks and Whites, the authors noted. Blacks had an overall excess mortality of 13.8% versus 5.1% for Whites, compared with the prepandemic years. The differences were consistent across subtypes: MI (9.6% vs. 1.0%); stroke (14.5% vs. 6.9%); and HF (5.1% vs. –1.2%; P value for all < .001).

When the investigators looked at deaths on a yearly basis with 2018 as the baseline, they found CVD deaths increased by 1.5% in 2019, 15.8% in 2020, and 13.5% in 2021 among Black Americans, compared with 0.5%, 5.1%, and 5.7%, respectively, among White Americans.

Excess deaths from MI rose by 9.5% in 2020 and by 6.7% in 2021 among Blacks but fell by 1.2% in 2020 and by 1.0% in 2021 among Whites.

Disparities in excess HF mortality were similar, rising 9.1% and 4.1% in 2020 and 2021 among Blacks, while dipping 0.1% and 0.8% in 2020 and 2021 among Whites.

The “most striking difference” was in excess stroke mortality, which doubled among Blacks compared with whites in 2020 (14.9% vs. 6.7%) and in 2021 (17.5% vs. 8.1%), according to the authors.
 

Awareness urged

Although the disparities were expected, “there is clear value in documenting and quantifying the magnitude of these disparities,” Amil M. Shah, MD, MPH, of Harvard Medical School and Brigham and Women’s Hospital, both in Boston, said in an interview.

In addition to being observational, the main limitation of the study, he noted, is the quality and resolution of the death certificate data, which may limit the accuracy of the cause of death ascertainment and classification of race or ethnicity. “However, I think these potential inaccuracies are unlikely to materially impact the overall study findings.”

Dr. Shah, who was not involved in the study, said he would like to see additional research into the diversity and heterogeneity in risk among Black communities. “Understanding the environmental, social, and health care factors – both harmful and protective – that influence risk for CVD morbidity and mortality among Black individuals and communities offers the promise to provide actionable insights to mitigate these disparities.”

“Intervention studies testing approaches to mitigate disparities based on race/ethnicity” are also needed, he added. These may be at the policy, community, health system, or individual level, and community involvement in phases will be essential.”

Meanwhile, both Dr. Al-Kindi and Dr. Shah urged clinicians to be aware of the disparities and the need to improve access to care and address social determinants of health in vulnerable populations.

These disparities “are driven by structural factors, and are reinforced by individual behaviors. In this context, implicit bias training is important to help clinicians recognize and mitigate bias in their own practice,” Dr. Shah said. “Supporting diversity, equity, and inclusion efforts, and advocating for anti-racist policies and practices in their health systems” can also help.

Dr. Al-Kindi and Dr. Shah disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Cardiovascular disease (CVD) mortality rose significantly during the COVID-19 pandemic and persists more than 2 years on and, once again, Blacks and African Americans have been disproportionately affected, an analysis of death certificates shows.

The findings “suggest that the pandemic may reverse years or decades of work aimed at reducing gaps in cardiovascular outcomes,” Sadeer G. Al-Kindi, MD, Case Western Reserve University, Cleveland, said in an interview.

Although the disparities are in line with previous research, he said, “what was surprising is the persistence of excess cardiovascular mortality approximately 2 years after the pandemic started, even during a period of low COVID-19 mortality.”

“This suggests that the pandemic resulted in a disruption of health care access and, along with disparities in COVID-19 infection and its complications, he said, “may have a long-lasting effect on health care disparities, especially among vulnerable populations.”

The study was published online in Mayo Clinic Proceedings with lead author Scott E. Janus, MD, also of Case Western Reserve University.
 

Impact consistently greater for Blacks

Dr. Al-Kindi and colleagues used 3,598,352 U.S. death files to investigate trends in deaths caused specifically by CVD as well as its subtypes myocardial infarction, stroke, and heart failure (HF) in 2018 and 2019 (prepandemic) and the pandemic years 2020 and 2021. Baseline demographics showed a higher percentage of older, female, and Black individuals among the CVD subtypes of interest.

Overall, there was an excess CVD mortality of 6.7% during the pandemic, compared with prepandemic years, including a 2.5% rise in MI deaths and an 8.5% rise in stroke deaths. HF mortality remained relatively steady, rising only 0.1%.

Subgroup analyses revealed “striking differences” in excess mortality between Blacks and Whites, the authors noted. Blacks had an overall excess mortality of 13.8% versus 5.1% for Whites, compared with the prepandemic years. The differences were consistent across subtypes: MI (9.6% vs. 1.0%); stroke (14.5% vs. 6.9%); and HF (5.1% vs. –1.2%; P value for all < .001).

When the investigators looked at deaths on a yearly basis with 2018 as the baseline, they found CVD deaths increased by 1.5% in 2019, 15.8% in 2020, and 13.5% in 2021 among Black Americans, compared with 0.5%, 5.1%, and 5.7%, respectively, among White Americans.

Excess deaths from MI rose by 9.5% in 2020 and by 6.7% in 2021 among Blacks but fell by 1.2% in 2020 and by 1.0% in 2021 among Whites.

Disparities in excess HF mortality were similar, rising 9.1% and 4.1% in 2020 and 2021 among Blacks, while dipping 0.1% and 0.8% in 2020 and 2021 among Whites.

The “most striking difference” was in excess stroke mortality, which doubled among Blacks compared with whites in 2020 (14.9% vs. 6.7%) and in 2021 (17.5% vs. 8.1%), according to the authors.
 

Awareness urged

Although the disparities were expected, “there is clear value in documenting and quantifying the magnitude of these disparities,” Amil M. Shah, MD, MPH, of Harvard Medical School and Brigham and Women’s Hospital, both in Boston, said in an interview.

In addition to being observational, the main limitation of the study, he noted, is the quality and resolution of the death certificate data, which may limit the accuracy of the cause of death ascertainment and classification of race or ethnicity. “However, I think these potential inaccuracies are unlikely to materially impact the overall study findings.”

Dr. Shah, who was not involved in the study, said he would like to see additional research into the diversity and heterogeneity in risk among Black communities. “Understanding the environmental, social, and health care factors – both harmful and protective – that influence risk for CVD morbidity and mortality among Black individuals and communities offers the promise to provide actionable insights to mitigate these disparities.”

“Intervention studies testing approaches to mitigate disparities based on race/ethnicity” are also needed, he added. These may be at the policy, community, health system, or individual level, and community involvement in phases will be essential.”

Meanwhile, both Dr. Al-Kindi and Dr. Shah urged clinicians to be aware of the disparities and the need to improve access to care and address social determinants of health in vulnerable populations.

These disparities “are driven by structural factors, and are reinforced by individual behaviors. In this context, implicit bias training is important to help clinicians recognize and mitigate bias in their own practice,” Dr. Shah said. “Supporting diversity, equity, and inclusion efforts, and advocating for anti-racist policies and practices in their health systems” can also help.

Dr. Al-Kindi and Dr. Shah disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.