AAP updates guidance on HIV testing and prophylaxis in youth

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Changed
Tue, 12/21/2021 - 08:54

Pediatricians should take a more proactive role in protecting children and adolescents from HIV infections, according to updated guidance from the American Academy of Pediatrics. The comprehensive new recommendations stress winning the trust and confidence of pediatric patients and reaffirm support for testing and treating adolescents without parental consent where state laws allow.

Dr. Natella Y. Rakhmanina

While the number of HIV-infected people in the United States remains high, most sexually active youth do not believe they are at risk and have never been tested, noted authors Katherine K. Hsu, MD, MPH, of the Massachusetts Department of Public Health and Boston University Medical Center, and Natella Yurievna Rakhmanina, MD, PhD, of Children’s National Hospital and George Washington University, both in Washington.

That is a knowledge gap that pediatricians are well situated to fill. “Pediatricians can play a key role in preventing and controlling HIV infection by promoting risk-reduction counseling and offering routine HIV testing and prophylaxis to adolescent and young adult (youth) patients,” they wrote on Dec. 20, 2021, in their study published in Pediatrics.

Key components of youth encounters, they stressed, is creating safe environments for obtaining an accurate sexual and reproductive health assessment and providing nonstigmatizing risk counseling.

According to Dr. Rakhmanina, major barriers to addressing preventive HIV counseling have included pediatricians’ lack of time, cultural differences, adolescents’ inaccurate responses, discomfort discussing sexual issues, and adolescents’ fear of parent or caregiver notification. Other concerns have been lack of adequate payment and insufficient training in how to talk to adolescents about sexual and reproductive issues.

According to the Centers for Disease Control and Prevention, at year end in 2018 an estimated 1,173,900 people age 13 or older were living with HIV infection in the United States, of whom 47,800 (4%) were adolescents and young adults 13-24 years of age.

These estimates include diagnosed and undiagnosed individuals. Between 2014 and 2018, new diagnoses of HIV infection accounted for 21% (7,817 of 37,515) of all new HIV diagnoses in the United States.

The new AAP clinical report updates policy statements from 2001 and again 2011 that encouraged HIV testing of all sexually active youth.

It reflects changes in epidemiology, advances in diagnostic testing with improved immunoassays, and updated recommendations for HIV testing and postexposure prophylaxis (PEP), as well as new guidance for pre-exposure prophylaxis (PrEP).

A 2017 study found that the 2011 HIV testing guidelines was associated with only a slight increase in HIV screening and a shift toward testing younger people and away from testing on the basis of risk.

Against this backdrop of persistent HIV infection and to-date modest uptake of earlier guidance, the 2021 statement made 14 main recommendations to pediatricians. Among these:
 

  • Foster open discussion of gender and sexual orientation and behavior, as well as reproductive health issues.
  • Recognize the clinical presentation of the acute retroviral syndrome, which can present as syndromes resembling infectious mononucleosis and influenza.
  • Consider including virologic testing in the diagnostic workup of sexually active youth.
  • Consider routine HIV screening for all youth 15 years or older at least once and rescreening high-risk youth. Those at higher risk should be rescreened at least annually, and potentially as frequently as every 3-6 months.
  • Youth at substantial risk should be routinely offered PrEP, while PEP with antiretroviral drugs is indicated after unsafe exposures such as unsafe sexual activity, unsafe needle use, or sexual violence. Survivors of sexual violence should have baseline HIV testing and sexually transmitted infection (STI) screening and treatment. They should also be offered mental health and other supportive counseling.
  • Test youth who request HIV screening at any time even in the absence of reported risk factors. Although parent or guardian involvement is preferable, in most legal settings the adolescent’s consent should suffice for testing and treatment.
  • For youth with a positive HIV test, facilitate and confirm prompt linkage to age-appropriate HIV specialty care.

Dr. Maria E. Trent

Will the current report’s recommendations be met with greater uptake than previous iterations? Yes, according to Maria E. Trent, MD, MPH, chief of the division of adolescent/young adult medicine at Johns Hopkins University, Baltimore, but a fundamental first step will be the establishment of honesty and confidentiality. “Pediatricians are essential stakeholders in HIV prevention and intervention efforts in the United States. Recent data, however, suggest that pediatricians often struggle to create the essential alone time with adolescents and young adults to conduct critical sexual health conversations that allow for adequate STI/HIV risk screening,” said Dr. Trent, who was not involved in the report. “Consistently creating that space will be the first task for ensuring adherence to these recommendations.”

Strategies to optimize risk screening for clinical decision support, such as confidential online previsit questionnaires that link to the electronic medical record, may facilitate discussions during the visit while maintaining clinician efficiency, she added.

Furthermore, while one-time general HIV screening during adolescence will be an easy goal, “integrating annual testing, biomedical intervention for PrEP/PEP, and ongoing follow-up and testing for those on biomedical intervention may present practical but not insurmountable challenges,” Dr. Trent said.

When pediatricians recognize that care is suboptimal in practice, ensuring that pediatricians have established linkages to adolescent-friendly services for free or low-cost HIV testing, PrEP/PEP, and HIV management will prevent gaps in care, Dr. Trent continued. “The most exciting development in health care is that telemedicine can now be used to work with young people, giving the practicing pediatrician more opportunities and flexibility to deliver and triage care.”

Will any of the guidelines such as an adolescent’s right to independent consent be considered unacceptable by parents? “While this part of the recommendations is not new, the thought that their adolescent can initiate and receive confidential care for HIV prevention or intervention without their knowledge or consent may initially be challenging to process,” Dr. Trent said. “Ultimately, what I’ve observed in practice is that parents are relieved and often proud of their young person for taking the initiative to engage in self-care to maintain their health and relieved to be involved as a critical support person.”

She added that pediatricians need to make their practice policies clear and have information available for parents on state laws related to confidential care. “They also need to carefully use the electronic health record to avoid errors in disclosures to proxies without patient consent.”

Dr. Rakhmanina agreed there will likely be greater adherence to this round of recommendations. “The culture of addressing sexual and reproductive health issues among adolescents in the U.S. is changing among pediatric providers, and we start seeing more champions of PrEP and HIV testing in our communities,” she said.

This study received no external funding. The authors had no financial relationships or potential conflicts of interest to disclose. Dr. Trent disclosed no competing interests relevant to her comments.

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Pediatricians should take a more proactive role in protecting children and adolescents from HIV infections, according to updated guidance from the American Academy of Pediatrics. The comprehensive new recommendations stress winning the trust and confidence of pediatric patients and reaffirm support for testing and treating adolescents without parental consent where state laws allow.

Dr. Natella Y. Rakhmanina

While the number of HIV-infected people in the United States remains high, most sexually active youth do not believe they are at risk and have never been tested, noted authors Katherine K. Hsu, MD, MPH, of the Massachusetts Department of Public Health and Boston University Medical Center, and Natella Yurievna Rakhmanina, MD, PhD, of Children’s National Hospital and George Washington University, both in Washington.

That is a knowledge gap that pediatricians are well situated to fill. “Pediatricians can play a key role in preventing and controlling HIV infection by promoting risk-reduction counseling and offering routine HIV testing and prophylaxis to adolescent and young adult (youth) patients,” they wrote on Dec. 20, 2021, in their study published in Pediatrics.

Key components of youth encounters, they stressed, is creating safe environments for obtaining an accurate sexual and reproductive health assessment and providing nonstigmatizing risk counseling.

According to Dr. Rakhmanina, major barriers to addressing preventive HIV counseling have included pediatricians’ lack of time, cultural differences, adolescents’ inaccurate responses, discomfort discussing sexual issues, and adolescents’ fear of parent or caregiver notification. Other concerns have been lack of adequate payment and insufficient training in how to talk to adolescents about sexual and reproductive issues.

According to the Centers for Disease Control and Prevention, at year end in 2018 an estimated 1,173,900 people age 13 or older were living with HIV infection in the United States, of whom 47,800 (4%) were adolescents and young adults 13-24 years of age.

These estimates include diagnosed and undiagnosed individuals. Between 2014 and 2018, new diagnoses of HIV infection accounted for 21% (7,817 of 37,515) of all new HIV diagnoses in the United States.

The new AAP clinical report updates policy statements from 2001 and again 2011 that encouraged HIV testing of all sexually active youth.

It reflects changes in epidemiology, advances in diagnostic testing with improved immunoassays, and updated recommendations for HIV testing and postexposure prophylaxis (PEP), as well as new guidance for pre-exposure prophylaxis (PrEP).

A 2017 study found that the 2011 HIV testing guidelines was associated with only a slight increase in HIV screening and a shift toward testing younger people and away from testing on the basis of risk.

Against this backdrop of persistent HIV infection and to-date modest uptake of earlier guidance, the 2021 statement made 14 main recommendations to pediatricians. Among these:
 

  • Foster open discussion of gender and sexual orientation and behavior, as well as reproductive health issues.
  • Recognize the clinical presentation of the acute retroviral syndrome, which can present as syndromes resembling infectious mononucleosis and influenza.
  • Consider including virologic testing in the diagnostic workup of sexually active youth.
  • Consider routine HIV screening for all youth 15 years or older at least once and rescreening high-risk youth. Those at higher risk should be rescreened at least annually, and potentially as frequently as every 3-6 months.
  • Youth at substantial risk should be routinely offered PrEP, while PEP with antiretroviral drugs is indicated after unsafe exposures such as unsafe sexual activity, unsafe needle use, or sexual violence. Survivors of sexual violence should have baseline HIV testing and sexually transmitted infection (STI) screening and treatment. They should also be offered mental health and other supportive counseling.
  • Test youth who request HIV screening at any time even in the absence of reported risk factors. Although parent or guardian involvement is preferable, in most legal settings the adolescent’s consent should suffice for testing and treatment.
  • For youth with a positive HIV test, facilitate and confirm prompt linkage to age-appropriate HIV specialty care.

Dr. Maria E. Trent

Will the current report’s recommendations be met with greater uptake than previous iterations? Yes, according to Maria E. Trent, MD, MPH, chief of the division of adolescent/young adult medicine at Johns Hopkins University, Baltimore, but a fundamental first step will be the establishment of honesty and confidentiality. “Pediatricians are essential stakeholders in HIV prevention and intervention efforts in the United States. Recent data, however, suggest that pediatricians often struggle to create the essential alone time with adolescents and young adults to conduct critical sexual health conversations that allow for adequate STI/HIV risk screening,” said Dr. Trent, who was not involved in the report. “Consistently creating that space will be the first task for ensuring adherence to these recommendations.”

Strategies to optimize risk screening for clinical decision support, such as confidential online previsit questionnaires that link to the electronic medical record, may facilitate discussions during the visit while maintaining clinician efficiency, she added.

Furthermore, while one-time general HIV screening during adolescence will be an easy goal, “integrating annual testing, biomedical intervention for PrEP/PEP, and ongoing follow-up and testing for those on biomedical intervention may present practical but not insurmountable challenges,” Dr. Trent said.

When pediatricians recognize that care is suboptimal in practice, ensuring that pediatricians have established linkages to adolescent-friendly services for free or low-cost HIV testing, PrEP/PEP, and HIV management will prevent gaps in care, Dr. Trent continued. “The most exciting development in health care is that telemedicine can now be used to work with young people, giving the practicing pediatrician more opportunities and flexibility to deliver and triage care.”

Will any of the guidelines such as an adolescent’s right to independent consent be considered unacceptable by parents? “While this part of the recommendations is not new, the thought that their adolescent can initiate and receive confidential care for HIV prevention or intervention without their knowledge or consent may initially be challenging to process,” Dr. Trent said. “Ultimately, what I’ve observed in practice is that parents are relieved and often proud of their young person for taking the initiative to engage in self-care to maintain their health and relieved to be involved as a critical support person.”

She added that pediatricians need to make their practice policies clear and have information available for parents on state laws related to confidential care. “They also need to carefully use the electronic health record to avoid errors in disclosures to proxies without patient consent.”

Dr. Rakhmanina agreed there will likely be greater adherence to this round of recommendations. “The culture of addressing sexual and reproductive health issues among adolescents in the U.S. is changing among pediatric providers, and we start seeing more champions of PrEP and HIV testing in our communities,” she said.

This study received no external funding. The authors had no financial relationships or potential conflicts of interest to disclose. Dr. Trent disclosed no competing interests relevant to her comments.

Pediatricians should take a more proactive role in protecting children and adolescents from HIV infections, according to updated guidance from the American Academy of Pediatrics. The comprehensive new recommendations stress winning the trust and confidence of pediatric patients and reaffirm support for testing and treating adolescents without parental consent where state laws allow.

Dr. Natella Y. Rakhmanina

While the number of HIV-infected people in the United States remains high, most sexually active youth do not believe they are at risk and have never been tested, noted authors Katherine K. Hsu, MD, MPH, of the Massachusetts Department of Public Health and Boston University Medical Center, and Natella Yurievna Rakhmanina, MD, PhD, of Children’s National Hospital and George Washington University, both in Washington.

That is a knowledge gap that pediatricians are well situated to fill. “Pediatricians can play a key role in preventing and controlling HIV infection by promoting risk-reduction counseling and offering routine HIV testing and prophylaxis to adolescent and young adult (youth) patients,” they wrote on Dec. 20, 2021, in their study published in Pediatrics.

Key components of youth encounters, they stressed, is creating safe environments for obtaining an accurate sexual and reproductive health assessment and providing nonstigmatizing risk counseling.

According to Dr. Rakhmanina, major barriers to addressing preventive HIV counseling have included pediatricians’ lack of time, cultural differences, adolescents’ inaccurate responses, discomfort discussing sexual issues, and adolescents’ fear of parent or caregiver notification. Other concerns have been lack of adequate payment and insufficient training in how to talk to adolescents about sexual and reproductive issues.

According to the Centers for Disease Control and Prevention, at year end in 2018 an estimated 1,173,900 people age 13 or older were living with HIV infection in the United States, of whom 47,800 (4%) were adolescents and young adults 13-24 years of age.

These estimates include diagnosed and undiagnosed individuals. Between 2014 and 2018, new diagnoses of HIV infection accounted for 21% (7,817 of 37,515) of all new HIV diagnoses in the United States.

The new AAP clinical report updates policy statements from 2001 and again 2011 that encouraged HIV testing of all sexually active youth.

It reflects changes in epidemiology, advances in diagnostic testing with improved immunoassays, and updated recommendations for HIV testing and postexposure prophylaxis (PEP), as well as new guidance for pre-exposure prophylaxis (PrEP).

A 2017 study found that the 2011 HIV testing guidelines was associated with only a slight increase in HIV screening and a shift toward testing younger people and away from testing on the basis of risk.

Against this backdrop of persistent HIV infection and to-date modest uptake of earlier guidance, the 2021 statement made 14 main recommendations to pediatricians. Among these:
 

  • Foster open discussion of gender and sexual orientation and behavior, as well as reproductive health issues.
  • Recognize the clinical presentation of the acute retroviral syndrome, which can present as syndromes resembling infectious mononucleosis and influenza.
  • Consider including virologic testing in the diagnostic workup of sexually active youth.
  • Consider routine HIV screening for all youth 15 years or older at least once and rescreening high-risk youth. Those at higher risk should be rescreened at least annually, and potentially as frequently as every 3-6 months.
  • Youth at substantial risk should be routinely offered PrEP, while PEP with antiretroviral drugs is indicated after unsafe exposures such as unsafe sexual activity, unsafe needle use, or sexual violence. Survivors of sexual violence should have baseline HIV testing and sexually transmitted infection (STI) screening and treatment. They should also be offered mental health and other supportive counseling.
  • Test youth who request HIV screening at any time even in the absence of reported risk factors. Although parent or guardian involvement is preferable, in most legal settings the adolescent’s consent should suffice for testing and treatment.
  • For youth with a positive HIV test, facilitate and confirm prompt linkage to age-appropriate HIV specialty care.

Dr. Maria E. Trent

Will the current report’s recommendations be met with greater uptake than previous iterations? Yes, according to Maria E. Trent, MD, MPH, chief of the division of adolescent/young adult medicine at Johns Hopkins University, Baltimore, but a fundamental first step will be the establishment of honesty and confidentiality. “Pediatricians are essential stakeholders in HIV prevention and intervention efforts in the United States. Recent data, however, suggest that pediatricians often struggle to create the essential alone time with adolescents and young adults to conduct critical sexual health conversations that allow for adequate STI/HIV risk screening,” said Dr. Trent, who was not involved in the report. “Consistently creating that space will be the first task for ensuring adherence to these recommendations.”

Strategies to optimize risk screening for clinical decision support, such as confidential online previsit questionnaires that link to the electronic medical record, may facilitate discussions during the visit while maintaining clinician efficiency, she added.

Furthermore, while one-time general HIV screening during adolescence will be an easy goal, “integrating annual testing, biomedical intervention for PrEP/PEP, and ongoing follow-up and testing for those on biomedical intervention may present practical but not insurmountable challenges,” Dr. Trent said.

When pediatricians recognize that care is suboptimal in practice, ensuring that pediatricians have established linkages to adolescent-friendly services for free or low-cost HIV testing, PrEP/PEP, and HIV management will prevent gaps in care, Dr. Trent continued. “The most exciting development in health care is that telemedicine can now be used to work with young people, giving the practicing pediatrician more opportunities and flexibility to deliver and triage care.”

Will any of the guidelines such as an adolescent’s right to independent consent be considered unacceptable by parents? “While this part of the recommendations is not new, the thought that their adolescent can initiate and receive confidential care for HIV prevention or intervention without their knowledge or consent may initially be challenging to process,” Dr. Trent said. “Ultimately, what I’ve observed in practice is that parents are relieved and often proud of their young person for taking the initiative to engage in self-care to maintain their health and relieved to be involved as a critical support person.”

She added that pediatricians need to make their practice policies clear and have information available for parents on state laws related to confidential care. “They also need to carefully use the electronic health record to avoid errors in disclosures to proxies without patient consent.”

Dr. Rakhmanina agreed there will likely be greater adherence to this round of recommendations. “The culture of addressing sexual and reproductive health issues among adolescents in the U.S. is changing among pediatric providers, and we start seeing more champions of PrEP and HIV testing in our communities,” she said.

This study received no external funding. The authors had no financial relationships or potential conflicts of interest to disclose. Dr. Trent disclosed no competing interests relevant to her comments.

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WPATH draft on gender dysphoria ‘skewed and misses urgent issues’

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Tue, 02/14/2023 - 12:59

New draft guidance from the World Professional Association for Transgender Health (WPATH) is raising serious concerns among professionals caring for people with gender dysphoria, prompting claims that WPATH is an organization “captured by activists.”

LemonTreeImages/Thinkstock

Experts in adolescent and child psychology, as well as pediatric health, have expressed dismay that the WPATH Standards of Care (SOC) 8 appear to miss some of the most urgent issues in the field of transgender medicine and are considered to express a radical and unreserved leaning towards “gender-affirmation.”

The WPATH SOC 8 document is available for view and comment until Dec. 16 until 11.59 PM EST, after which time revisions will be made and the final version published. 

Despite repeated attempts by this news organization to seek clarification on certain aspects of the guidance from members of the WPATH SOC 8 committee, requests were declined “until the guidance is finalized.”

According to the WPATH website, the SOC 8 aims to provide “clinical guidance for health professionals to assist transgender and gender diverse people with safe and effective pathways” to manage their gender dysphoria and potentially transition.

Such pathways may relate to primary care, gynecologic and urologic care, reproductive options, voice and communication therapy, mental health services, and hormonal or surgical treatments, among others.

WPATH adds that it was felt necessary to revise the existing SOC 7 (published in 2012) because of recent “globally unprecedented increase and visibility of transgender and gender-diverse people seeking support and gender-affirming medical treatment.”

Gender-affirming medical treatment means different things at different ages. In the case of kids with gender dysphoria who have not yet entered puberty associated with their birth sex, this might include prescribing so-called “puberty blockers” to delay natural puberty – gonadotrophin-releasing hormone analogs that are licensed for use in precocious puberty in children. Such agents have not been licensed for use in children with gender dysphoria, however, so any use for this purpose is off-label.

Following puberty blockade – or in cases where adolescents have already undergone natural puberty – the next step is to begin cross-sex hormones. So, for a female patient who wants to transition to male (FTM), that would be lifelong testosterone, and for a male who wants to be female (MTF), it involves lifelong estrogen. Again, use of such hormones in transgender individuals is entirely off-label.

Just last month, two of America’s leading experts on transgender medicine, both psychologists – including one who is transgender – told this news organization they were concerned that the quality of the evaluations of youth with gender dysphoria are being stifled by activists who are worried that open discussions will further stigmatize trans individuals.

They subsequently wrote an op-ed on the topic entitled, “The mental health establishment is failing trans kids,” which was finally published in the Washington Post on Nov. 24, after numerous other mainstream U.S. media outlets had rejected it.
 

New SOC 8 ‘is not evidence based,’ should not be new ‘gold standard’

One expert says the draft SOC 8 lacks balance and does not address certain issues, while paying undue attention to others that detract from real questions facing the field of transgender medicine, both in the United States and around the world.

Julia Mason, MD, is a pediatrician based in Gresham, Oregon, with a special interest in children and adolescents experiencing gender dysphoria. “The SOC 8 shows us that WPATH remains captured by activists,” she asserts. 

Dr. Mason questions the integrity of WPATH based on what she has read in the draft SOC 8.

“We need a serious organization to take a sober look at the evidence, and that is why we have established the Society for Evidence-Based Gender Medicine [SEGM],” she noted. “This is what we do – we are looking at all of the evidence.”

Dr. Mason is a clinical advisor to SEGM, an organization set-up to evaluate current interventions and evidence on gender dysphoria.

The pediatrician has particular concerns regarding the child and adolescent chapters in the draft SOC 8. The adolescent chapter states: “Guidelines are meant to provide a gold standard based on the available evidence at this moment of time.”

Dr. Mason disputes this assertion. “This document should not be the new gold standard going forward, primarily because it is not evidence based.”

In an interview, Dr. Mason explained that WPATH say they used the “Delphi consensus process” to determine their recommendations, but “this process is designed for use with a panel of experts when evidence is lacking. I would say they didn’t have a panel of experts. They largely had a panel of activists, with a few experts.”

There is no mention, for example, of England’s National Institute for Health and Care Excellence (NICE) evidence reviews on puberty blockers and cross-sex hormones from earlier this year. These reviews determined that no studies have compared cross-sex hormones or puberty blockers with a control group and all follow-up periods for cross-sex hormones were relatively short.

This disappoints Dr. Mason: “These are significant; they are important documents.”

And much of the evidence quoted comes from the well-known and often-quoted “Dutch-protocol” study of 2011, in which the children studied were much younger at the time of their gender dysphoria, compared with the many adolescents who make up the current surge in presentation at gender clinics worldwide, she adds.
 

Rapid-onset GD: adolescents presenting late with little history

Dr. Mason also stresses that the SOC 8 does not address the most urgent issues in transgender medicine today, mainly because it does not address rapid-onset gender dysphoria (ROGD): “This is the dilemma of the 21st century; it’s new.”

ROGD – a term first coined in 2018 by researcher Lisa Littman, MD, MPH, now president of the Institute for Comprehensive Gender Dysphoria Research (ICGDR) – refers to the phenomena of adolescents expressing a desire to transition from their birth sex after little or no apparent previous indication.

However, the SOC 8 does make reference to aspects of adolescent development that might impact their decision-making processes around gender identity during teen years. The chapter on adolescents reads: “... adolescence is also often associated with increased risk-taking behaviors. Along with these notable changes ... individuation from parents ... [there is] often a heightened focus on peer relationships, which can be both positive and detrimental.” 

The guidance goes on to point out that “it is critical to understand how all of these aspects of development may impact the decision-making for a given young person within their specific cultural context.” 
 

 

 

Desistance and detransitioning not adequately addressed

Dr. Mason also says there is little mention “about detransitioning in this SOC [8], and ‘gender dysphoria’ and ‘trans’ are terms that are not defined.” 

Likewise, there is no mention of desistance, she highlights, which is when individuals naturally resolve their dysphoria around their birth sex as they grow older.

The most recent published data seen by this news organization relates to a study from March 2021 that showed nearly 88% of boys who struggled with gender identity in childhood (approximate mean age 8 years and follow-up at approximate mean age 20 years) desisted. It reads: “Of the 139 participants, 17 (12.2%) were classified as ‘persisters’ and the remaining 122 (87.8%) were classified as desisters.”

“Most children with gender dysphoria will desist and lose their concept of themselves as being the opposite gender,” Dr. Mason explains. “This is the safest path for a child – desistance.”

“Transition can turn a healthy young person into a lifelong medical patient and has significant health risks,” she emphasizes, stressing that transition has not been shown to decrease the probability of suicide, or attempts at suicide, despite myriad claims saying otherwise. 

“Before we were routinely transitioning kids at school, the vast majority of children grew out of their gender dysphoria. This history is not recognized at all in these SOC [8],” she maintains.

Ken Zucker, PhD, CPsych, an author of the study of desistance in boys, says the terms desistence and persistence of gender dysphoria have caused some consternation in certain circles.

An editor of the Archives of Sexual Behavior and professor in the department of psychiatry, University of Toronto, Dr. Zucker has published widely on the topic.

He told this news organization: “The terms persistence and desistance have become verboten among the WPATH cognoscenti. Perhaps the contributors to SOC 8 have come up with alternative descriptors.”  

“The term ‘desistance’ is particularly annoying to some of the gender-affirming clinicians, because they don’t believe that desistance is bona fide,” Dr. Zucker points out.

“The desistance resisters are like anti-vaxxers – nothing one can provide as evidence for the efficacy of vaccines is sufficient. There will always be a new objection.” 

Other mental health issues, in particular ADHD and autism

It is also widely acknowledged that there is a higher rate of neurodevelopmental and psychiatric diagnoses in individuals with gender dysphoria. For example, one 2020 study found that transgender people were three to six times as likely to be autistic as cisgender people (those whose gender is aligned with their birth sex). 

Statement one in the chapter on adolescents in draft WPATH SOC 8 does give a nod to this, pointing out that health professionals working with gender diverse adolescents “should receive training and develop expertise in autism spectrum disorders and other neurodiversity conditions.”

It also notes that in some cases “a more extended assessment process may be useful, such as for youth with more complex presentations (e.g., complicated mental health histories, co-occurring autism spectrum characteristics in particular) and an absence of experienced childhood gender incongruence.”

However, Dr. Mason stresses that underlying mental health issues are central to addressing how to manage a significant number of these patients.

“If a young person has ADHD or autism, they are not ready to make decisions about the rest of their life at age 18. Even a neurotypical young person is still developing their frontal cortex in their early 20s, and it takes longer for those with ADHD or on the autism spectrum.”

She firmly believes that the guidance does not give sufficient consideration to comorbidities in people over the age of 18.

According to their [SOC 8] guidelines, “once someone is 18 they are ready for anything,” says Dr. Mason.  

Offering some explanation for the increased prevalence of ADHD and autism in those with gender dysphoria, Dr. Mason notes that children can have “hyperfocus” and those with autism will fixate on a particular area of interest. “If a child is unhappy in their life, and this can be more likely if someone is neuro-atypical, then it is likely that the individual might go online and find this one solution [for example, a transgender identity] that seems to fix everything.” 

Perceptions of femininity and masculinity can also be extra challenging for a child with autism, Dr. Mason says. “It is relatively easy for an autistic girl to feel like she should be a boy because the rules of femininity are composed of nonverbal, subtle behaviors that can be difficult to pick up on,” she points out. “An autistic child who isn’t particularly good at nonverbal communication might not pick up on these and thus feel they are not very ‘female.’” 

“There’s a whole lot of grass-is-greener-type thinking. Girls think boys have an easier life, and boys think girls have an easier life. I know some detransitioners who have spoken eloquently about realizing their mistake on this,” she adds.

Other parts of the SOC 8 that Dr. Mason disagrees with include the recommendation in the adolescent chapter that 14-year-olds are mature enough to start cross-sex hormones, that is, giving testosterone to a female who wants to transition to male or estrogen to a male who wishes to transition to female. “I think that’s far too young,” she asserts.

And she points out that the document states 17-year-olds are ready for genital reassignment surgery. Again, she believes this is far too young.

“Also, the SOC 8 document does not clarify who is appropriate for surgery. Whenever surgery is discussed, it becomes very vague,” she said. 

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

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New draft guidance from the World Professional Association for Transgender Health (WPATH) is raising serious concerns among professionals caring for people with gender dysphoria, prompting claims that WPATH is an organization “captured by activists.”

LemonTreeImages/Thinkstock

Experts in adolescent and child psychology, as well as pediatric health, have expressed dismay that the WPATH Standards of Care (SOC) 8 appear to miss some of the most urgent issues in the field of transgender medicine and are considered to express a radical and unreserved leaning towards “gender-affirmation.”

The WPATH SOC 8 document is available for view and comment until Dec. 16 until 11.59 PM EST, after which time revisions will be made and the final version published. 

Despite repeated attempts by this news organization to seek clarification on certain aspects of the guidance from members of the WPATH SOC 8 committee, requests were declined “until the guidance is finalized.”

According to the WPATH website, the SOC 8 aims to provide “clinical guidance for health professionals to assist transgender and gender diverse people with safe and effective pathways” to manage their gender dysphoria and potentially transition.

Such pathways may relate to primary care, gynecologic and urologic care, reproductive options, voice and communication therapy, mental health services, and hormonal or surgical treatments, among others.

WPATH adds that it was felt necessary to revise the existing SOC 7 (published in 2012) because of recent “globally unprecedented increase and visibility of transgender and gender-diverse people seeking support and gender-affirming medical treatment.”

Gender-affirming medical treatment means different things at different ages. In the case of kids with gender dysphoria who have not yet entered puberty associated with their birth sex, this might include prescribing so-called “puberty blockers” to delay natural puberty – gonadotrophin-releasing hormone analogs that are licensed for use in precocious puberty in children. Such agents have not been licensed for use in children with gender dysphoria, however, so any use for this purpose is off-label.

Following puberty blockade – or in cases where adolescents have already undergone natural puberty – the next step is to begin cross-sex hormones. So, for a female patient who wants to transition to male (FTM), that would be lifelong testosterone, and for a male who wants to be female (MTF), it involves lifelong estrogen. Again, use of such hormones in transgender individuals is entirely off-label.

Just last month, two of America’s leading experts on transgender medicine, both psychologists – including one who is transgender – told this news organization they were concerned that the quality of the evaluations of youth with gender dysphoria are being stifled by activists who are worried that open discussions will further stigmatize trans individuals.

They subsequently wrote an op-ed on the topic entitled, “The mental health establishment is failing trans kids,” which was finally published in the Washington Post on Nov. 24, after numerous other mainstream U.S. media outlets had rejected it.
 

New SOC 8 ‘is not evidence based,’ should not be new ‘gold standard’

One expert says the draft SOC 8 lacks balance and does not address certain issues, while paying undue attention to others that detract from real questions facing the field of transgender medicine, both in the United States and around the world.

Julia Mason, MD, is a pediatrician based in Gresham, Oregon, with a special interest in children and adolescents experiencing gender dysphoria. “The SOC 8 shows us that WPATH remains captured by activists,” she asserts. 

Dr. Mason questions the integrity of WPATH based on what she has read in the draft SOC 8.

“We need a serious organization to take a sober look at the evidence, and that is why we have established the Society for Evidence-Based Gender Medicine [SEGM],” she noted. “This is what we do – we are looking at all of the evidence.”

Dr. Mason is a clinical advisor to SEGM, an organization set-up to evaluate current interventions and evidence on gender dysphoria.

The pediatrician has particular concerns regarding the child and adolescent chapters in the draft SOC 8. The adolescent chapter states: “Guidelines are meant to provide a gold standard based on the available evidence at this moment of time.”

Dr. Mason disputes this assertion. “This document should not be the new gold standard going forward, primarily because it is not evidence based.”

In an interview, Dr. Mason explained that WPATH say they used the “Delphi consensus process” to determine their recommendations, but “this process is designed for use with a panel of experts when evidence is lacking. I would say they didn’t have a panel of experts. They largely had a panel of activists, with a few experts.”

There is no mention, for example, of England’s National Institute for Health and Care Excellence (NICE) evidence reviews on puberty blockers and cross-sex hormones from earlier this year. These reviews determined that no studies have compared cross-sex hormones or puberty blockers with a control group and all follow-up periods for cross-sex hormones were relatively short.

This disappoints Dr. Mason: “These are significant; they are important documents.”

And much of the evidence quoted comes from the well-known and often-quoted “Dutch-protocol” study of 2011, in which the children studied were much younger at the time of their gender dysphoria, compared with the many adolescents who make up the current surge in presentation at gender clinics worldwide, she adds.
 

Rapid-onset GD: adolescents presenting late with little history

Dr. Mason also stresses that the SOC 8 does not address the most urgent issues in transgender medicine today, mainly because it does not address rapid-onset gender dysphoria (ROGD): “This is the dilemma of the 21st century; it’s new.”

ROGD – a term first coined in 2018 by researcher Lisa Littman, MD, MPH, now president of the Institute for Comprehensive Gender Dysphoria Research (ICGDR) – refers to the phenomena of adolescents expressing a desire to transition from their birth sex after little or no apparent previous indication.

However, the SOC 8 does make reference to aspects of adolescent development that might impact their decision-making processes around gender identity during teen years. The chapter on adolescents reads: “... adolescence is also often associated with increased risk-taking behaviors. Along with these notable changes ... individuation from parents ... [there is] often a heightened focus on peer relationships, which can be both positive and detrimental.” 

The guidance goes on to point out that “it is critical to understand how all of these aspects of development may impact the decision-making for a given young person within their specific cultural context.” 
 

 

 

Desistance and detransitioning not adequately addressed

Dr. Mason also says there is little mention “about detransitioning in this SOC [8], and ‘gender dysphoria’ and ‘trans’ are terms that are not defined.” 

Likewise, there is no mention of desistance, she highlights, which is when individuals naturally resolve their dysphoria around their birth sex as they grow older.

The most recent published data seen by this news organization relates to a study from March 2021 that showed nearly 88% of boys who struggled with gender identity in childhood (approximate mean age 8 years and follow-up at approximate mean age 20 years) desisted. It reads: “Of the 139 participants, 17 (12.2%) were classified as ‘persisters’ and the remaining 122 (87.8%) were classified as desisters.”

“Most children with gender dysphoria will desist and lose their concept of themselves as being the opposite gender,” Dr. Mason explains. “This is the safest path for a child – desistance.”

“Transition can turn a healthy young person into a lifelong medical patient and has significant health risks,” she emphasizes, stressing that transition has not been shown to decrease the probability of suicide, or attempts at suicide, despite myriad claims saying otherwise. 

“Before we were routinely transitioning kids at school, the vast majority of children grew out of their gender dysphoria. This history is not recognized at all in these SOC [8],” she maintains.

Ken Zucker, PhD, CPsych, an author of the study of desistance in boys, says the terms desistence and persistence of gender dysphoria have caused some consternation in certain circles.

An editor of the Archives of Sexual Behavior and professor in the department of psychiatry, University of Toronto, Dr. Zucker has published widely on the topic.

He told this news organization: “The terms persistence and desistance have become verboten among the WPATH cognoscenti. Perhaps the contributors to SOC 8 have come up with alternative descriptors.”  

“The term ‘desistance’ is particularly annoying to some of the gender-affirming clinicians, because they don’t believe that desistance is bona fide,” Dr. Zucker points out.

“The desistance resisters are like anti-vaxxers – nothing one can provide as evidence for the efficacy of vaccines is sufficient. There will always be a new objection.” 

Other mental health issues, in particular ADHD and autism

It is also widely acknowledged that there is a higher rate of neurodevelopmental and psychiatric diagnoses in individuals with gender dysphoria. For example, one 2020 study found that transgender people were three to six times as likely to be autistic as cisgender people (those whose gender is aligned with their birth sex). 

Statement one in the chapter on adolescents in draft WPATH SOC 8 does give a nod to this, pointing out that health professionals working with gender diverse adolescents “should receive training and develop expertise in autism spectrum disorders and other neurodiversity conditions.”

It also notes that in some cases “a more extended assessment process may be useful, such as for youth with more complex presentations (e.g., complicated mental health histories, co-occurring autism spectrum characteristics in particular) and an absence of experienced childhood gender incongruence.”

However, Dr. Mason stresses that underlying mental health issues are central to addressing how to manage a significant number of these patients.

“If a young person has ADHD or autism, they are not ready to make decisions about the rest of their life at age 18. Even a neurotypical young person is still developing their frontal cortex in their early 20s, and it takes longer for those with ADHD or on the autism spectrum.”

She firmly believes that the guidance does not give sufficient consideration to comorbidities in people over the age of 18.

According to their [SOC 8] guidelines, “once someone is 18 they are ready for anything,” says Dr. Mason.  

Offering some explanation for the increased prevalence of ADHD and autism in those with gender dysphoria, Dr. Mason notes that children can have “hyperfocus” and those with autism will fixate on a particular area of interest. “If a child is unhappy in their life, and this can be more likely if someone is neuro-atypical, then it is likely that the individual might go online and find this one solution [for example, a transgender identity] that seems to fix everything.” 

Perceptions of femininity and masculinity can also be extra challenging for a child with autism, Dr. Mason says. “It is relatively easy for an autistic girl to feel like she should be a boy because the rules of femininity are composed of nonverbal, subtle behaviors that can be difficult to pick up on,” she points out. “An autistic child who isn’t particularly good at nonverbal communication might not pick up on these and thus feel they are not very ‘female.’” 

“There’s a whole lot of grass-is-greener-type thinking. Girls think boys have an easier life, and boys think girls have an easier life. I know some detransitioners who have spoken eloquently about realizing their mistake on this,” she adds.

Other parts of the SOC 8 that Dr. Mason disagrees with include the recommendation in the adolescent chapter that 14-year-olds are mature enough to start cross-sex hormones, that is, giving testosterone to a female who wants to transition to male or estrogen to a male who wishes to transition to female. “I think that’s far too young,” she asserts.

And she points out that the document states 17-year-olds are ready for genital reassignment surgery. Again, she believes this is far too young.

“Also, the SOC 8 document does not clarify who is appropriate for surgery. Whenever surgery is discussed, it becomes very vague,” she said. 

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

New draft guidance from the World Professional Association for Transgender Health (WPATH) is raising serious concerns among professionals caring for people with gender dysphoria, prompting claims that WPATH is an organization “captured by activists.”

LemonTreeImages/Thinkstock

Experts in adolescent and child psychology, as well as pediatric health, have expressed dismay that the WPATH Standards of Care (SOC) 8 appear to miss some of the most urgent issues in the field of transgender medicine and are considered to express a radical and unreserved leaning towards “gender-affirmation.”

The WPATH SOC 8 document is available for view and comment until Dec. 16 until 11.59 PM EST, after which time revisions will be made and the final version published. 

Despite repeated attempts by this news organization to seek clarification on certain aspects of the guidance from members of the WPATH SOC 8 committee, requests were declined “until the guidance is finalized.”

According to the WPATH website, the SOC 8 aims to provide “clinical guidance for health professionals to assist transgender and gender diverse people with safe and effective pathways” to manage their gender dysphoria and potentially transition.

Such pathways may relate to primary care, gynecologic and urologic care, reproductive options, voice and communication therapy, mental health services, and hormonal or surgical treatments, among others.

WPATH adds that it was felt necessary to revise the existing SOC 7 (published in 2012) because of recent “globally unprecedented increase and visibility of transgender and gender-diverse people seeking support and gender-affirming medical treatment.”

Gender-affirming medical treatment means different things at different ages. In the case of kids with gender dysphoria who have not yet entered puberty associated with their birth sex, this might include prescribing so-called “puberty blockers” to delay natural puberty – gonadotrophin-releasing hormone analogs that are licensed for use in precocious puberty in children. Such agents have not been licensed for use in children with gender dysphoria, however, so any use for this purpose is off-label.

Following puberty blockade – or in cases where adolescents have already undergone natural puberty – the next step is to begin cross-sex hormones. So, for a female patient who wants to transition to male (FTM), that would be lifelong testosterone, and for a male who wants to be female (MTF), it involves lifelong estrogen. Again, use of such hormones in transgender individuals is entirely off-label.

Just last month, two of America’s leading experts on transgender medicine, both psychologists – including one who is transgender – told this news organization they were concerned that the quality of the evaluations of youth with gender dysphoria are being stifled by activists who are worried that open discussions will further stigmatize trans individuals.

They subsequently wrote an op-ed on the topic entitled, “The mental health establishment is failing trans kids,” which was finally published in the Washington Post on Nov. 24, after numerous other mainstream U.S. media outlets had rejected it.
 

New SOC 8 ‘is not evidence based,’ should not be new ‘gold standard’

One expert says the draft SOC 8 lacks balance and does not address certain issues, while paying undue attention to others that detract from real questions facing the field of transgender medicine, both in the United States and around the world.

Julia Mason, MD, is a pediatrician based in Gresham, Oregon, with a special interest in children and adolescents experiencing gender dysphoria. “The SOC 8 shows us that WPATH remains captured by activists,” she asserts. 

Dr. Mason questions the integrity of WPATH based on what she has read in the draft SOC 8.

“We need a serious organization to take a sober look at the evidence, and that is why we have established the Society for Evidence-Based Gender Medicine [SEGM],” she noted. “This is what we do – we are looking at all of the evidence.”

Dr. Mason is a clinical advisor to SEGM, an organization set-up to evaluate current interventions and evidence on gender dysphoria.

The pediatrician has particular concerns regarding the child and adolescent chapters in the draft SOC 8. The adolescent chapter states: “Guidelines are meant to provide a gold standard based on the available evidence at this moment of time.”

Dr. Mason disputes this assertion. “This document should not be the new gold standard going forward, primarily because it is not evidence based.”

In an interview, Dr. Mason explained that WPATH say they used the “Delphi consensus process” to determine their recommendations, but “this process is designed for use with a panel of experts when evidence is lacking. I would say they didn’t have a panel of experts. They largely had a panel of activists, with a few experts.”

There is no mention, for example, of England’s National Institute for Health and Care Excellence (NICE) evidence reviews on puberty blockers and cross-sex hormones from earlier this year. These reviews determined that no studies have compared cross-sex hormones or puberty blockers with a control group and all follow-up periods for cross-sex hormones were relatively short.

This disappoints Dr. Mason: “These are significant; they are important documents.”

And much of the evidence quoted comes from the well-known and often-quoted “Dutch-protocol” study of 2011, in which the children studied were much younger at the time of their gender dysphoria, compared with the many adolescents who make up the current surge in presentation at gender clinics worldwide, she adds.
 

Rapid-onset GD: adolescents presenting late with little history

Dr. Mason also stresses that the SOC 8 does not address the most urgent issues in transgender medicine today, mainly because it does not address rapid-onset gender dysphoria (ROGD): “This is the dilemma of the 21st century; it’s new.”

ROGD – a term first coined in 2018 by researcher Lisa Littman, MD, MPH, now president of the Institute for Comprehensive Gender Dysphoria Research (ICGDR) – refers to the phenomena of adolescents expressing a desire to transition from their birth sex after little or no apparent previous indication.

However, the SOC 8 does make reference to aspects of adolescent development that might impact their decision-making processes around gender identity during teen years. The chapter on adolescents reads: “... adolescence is also often associated with increased risk-taking behaviors. Along with these notable changes ... individuation from parents ... [there is] often a heightened focus on peer relationships, which can be both positive and detrimental.” 

The guidance goes on to point out that “it is critical to understand how all of these aspects of development may impact the decision-making for a given young person within their specific cultural context.” 
 

 

 

Desistance and detransitioning not adequately addressed

Dr. Mason also says there is little mention “about detransitioning in this SOC [8], and ‘gender dysphoria’ and ‘trans’ are terms that are not defined.” 

Likewise, there is no mention of desistance, she highlights, which is when individuals naturally resolve their dysphoria around their birth sex as they grow older.

The most recent published data seen by this news organization relates to a study from March 2021 that showed nearly 88% of boys who struggled with gender identity in childhood (approximate mean age 8 years and follow-up at approximate mean age 20 years) desisted. It reads: “Of the 139 participants, 17 (12.2%) were classified as ‘persisters’ and the remaining 122 (87.8%) were classified as desisters.”

“Most children with gender dysphoria will desist and lose their concept of themselves as being the opposite gender,” Dr. Mason explains. “This is the safest path for a child – desistance.”

“Transition can turn a healthy young person into a lifelong medical patient and has significant health risks,” she emphasizes, stressing that transition has not been shown to decrease the probability of suicide, or attempts at suicide, despite myriad claims saying otherwise. 

“Before we were routinely transitioning kids at school, the vast majority of children grew out of their gender dysphoria. This history is not recognized at all in these SOC [8],” she maintains.

Ken Zucker, PhD, CPsych, an author of the study of desistance in boys, says the terms desistence and persistence of gender dysphoria have caused some consternation in certain circles.

An editor of the Archives of Sexual Behavior and professor in the department of psychiatry, University of Toronto, Dr. Zucker has published widely on the topic.

He told this news organization: “The terms persistence and desistance have become verboten among the WPATH cognoscenti. Perhaps the contributors to SOC 8 have come up with alternative descriptors.”  

“The term ‘desistance’ is particularly annoying to some of the gender-affirming clinicians, because they don’t believe that desistance is bona fide,” Dr. Zucker points out.

“The desistance resisters are like anti-vaxxers – nothing one can provide as evidence for the efficacy of vaccines is sufficient. There will always be a new objection.” 

Other mental health issues, in particular ADHD and autism

It is also widely acknowledged that there is a higher rate of neurodevelopmental and psychiatric diagnoses in individuals with gender dysphoria. For example, one 2020 study found that transgender people were three to six times as likely to be autistic as cisgender people (those whose gender is aligned with their birth sex). 

Statement one in the chapter on adolescents in draft WPATH SOC 8 does give a nod to this, pointing out that health professionals working with gender diverse adolescents “should receive training and develop expertise in autism spectrum disorders and other neurodiversity conditions.”

It also notes that in some cases “a more extended assessment process may be useful, such as for youth with more complex presentations (e.g., complicated mental health histories, co-occurring autism spectrum characteristics in particular) and an absence of experienced childhood gender incongruence.”

However, Dr. Mason stresses that underlying mental health issues are central to addressing how to manage a significant number of these patients.

“If a young person has ADHD or autism, they are not ready to make decisions about the rest of their life at age 18. Even a neurotypical young person is still developing their frontal cortex in their early 20s, and it takes longer for those with ADHD or on the autism spectrum.”

She firmly believes that the guidance does not give sufficient consideration to comorbidities in people over the age of 18.

According to their [SOC 8] guidelines, “once someone is 18 they are ready for anything,” says Dr. Mason.  

Offering some explanation for the increased prevalence of ADHD and autism in those with gender dysphoria, Dr. Mason notes that children can have “hyperfocus” and those with autism will fixate on a particular area of interest. “If a child is unhappy in their life, and this can be more likely if someone is neuro-atypical, then it is likely that the individual might go online and find this one solution [for example, a transgender identity] that seems to fix everything.” 

Perceptions of femininity and masculinity can also be extra challenging for a child with autism, Dr. Mason says. “It is relatively easy for an autistic girl to feel like she should be a boy because the rules of femininity are composed of nonverbal, subtle behaviors that can be difficult to pick up on,” she points out. “An autistic child who isn’t particularly good at nonverbal communication might not pick up on these and thus feel they are not very ‘female.’” 

“There’s a whole lot of grass-is-greener-type thinking. Girls think boys have an easier life, and boys think girls have an easier life. I know some detransitioners who have spoken eloquently about realizing their mistake on this,” she adds.

Other parts of the SOC 8 that Dr. Mason disagrees with include the recommendation in the adolescent chapter that 14-year-olds are mature enough to start cross-sex hormones, that is, giving testosterone to a female who wants to transition to male or estrogen to a male who wishes to transition to female. “I think that’s far too young,” she asserts.

And she points out that the document states 17-year-olds are ready for genital reassignment surgery. Again, she believes this is far too young.

“Also, the SOC 8 document does not clarify who is appropriate for surgery. Whenever surgery is discussed, it becomes very vague,” she said. 

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

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ACC, AHA issue new coronary revascularization guideline

Article Type
Changed
Mon, 12/13/2021 - 11:22

Clinicians should approach decisions regarding coronary revascularization based on clinical indications without an eye toward sex, race, or ethnicity, advises a joint clinical practice guideline released Dec. 8 by the American Heart Association and American College of Cardiology.

Dr. Jennifer S. Lawton

The new class 1 recommendation leads off the 109-page document and reflects evidence demonstrating that revascularization is equally beneficial for all patients. Still, studies show that women and non-White patients are less likely to receive reperfusion therapy or revascularization.

“This was extremely important to all the committee members because of all of the disparities that have been documented not only in diagnosis but [in] the care provided to underrepresented minorities, women, and other ethnic groups,” said Jennifer S. Lawton, MD, chief of cardiac surgery at Johns Hopkins University, Baltimore, and guideline writing committee chair.  

“We wanted to make it clear right at the beginning of the document that these guidelines apply to everyone, and we want it to be known that care should be the same for everyone,” she said in an interview.

The guideline was simultaneously published Dec. 9, 2021, in the journal  Circulation  and the  Journal of the American College of Cardiology

It updates and consolidates the ACC/AHA 2011 coronary artery bypass surgery (CABG) guideline and the ACC/AHA/Society for Cardiovascular Angiography and Interventions 2011 and 2015 percutaneous coronary intervention (PCI) guidelines.

The new document emphasizes in a class 1 recommendation the importance of the multidisciplinary heart team in patients with coronary artery disease (CAD) where the best treatment strategy is unclear. But it also stresses that treatment decisions should be patient centered – taking into account patient preferences and goals, cultural beliefs, health literacy, and social determinants of cardiovascular health – and made in collaboration with the patient’s support system.

“Oftentimes we recommend a strategy of revascularization that may not be what the patient wants or hasn’t taken into account the patient’s preferences and also the family members,” Dr. Lawson said. “So we felt that was very important.”

Patients should also be provided with available evidence for various treatment options, including risks and benefits of each option, for informed consent. The two new class 1 recommendations are highlighted in a figure illustrating the shared decision-making algorithm that, by design, features a female clinician and Black patient.

“We spent 2 years debating the best revascularization strategies and we’re considered experts in the field – but when we talk to our patients, they really don’t know the benefits and risks,” she said. “In order to translate it to the layperson in basic terms, it’s important to say, ‘If you choose this option, you will likely live longer’ rather than using the jargon.”
 

DAPT, staged PCI, stable IHD

Among the top 10 take-home messages highlighted by the authors is a 2a recommendation that 1-3 months of dual antiplatelet therapy (DAPT) after PCI with a transition to P2Y12 inhibitor monotherapy is “reasonable” in selected patients to reduce the risk of bleeding events. Previous recommendations called for 6 or 12 months of DAPT.

enot-poloskun/Getty Images

“We really respect all of the clinical trials that came out showing that a shorter duration of DAPT is not inferior in terms of ischemic events but less bleeding, yet I don’t know how many clinicians are actually just using 3 months of DAPT followed by P2Y12 monotherapy,” guideline committee vice chair Jacqueline Tamis-Holland, MD, professor of medicine, Icahn School of Medicine at Mount Sinai, New York, said in an interview. “So while it’s not a big, glaring giant recommendation, I think it will change a lot of practice.”

Similarly, she suggested that practice may shift as a result of a class 1 recommendation for staged PCI of a significantly stenosed nonculprit artery to reduce the risk for death or MI in selected hemodynamically stable patients presenting with ST-segment elevation MI and multivessel disease. “When you survey physicians, 75% of them do staged PCI but I think there will probably be more of an approach to staged PCI, as opposed to doing multivessel PCI at the time of primary PCI.”

Newer evidence from meta-analyses and the landmark ISCHEMIA trial showing no advantage of CABG over medical therapy in stable ischemic heart disease is reflected in a new class 2b recommendation – downgraded from class 1 in 2011 – that CABG “may be reasonable” to improve survival in stable patients with triple-vessel CAD.

The writing committee concluded that the ability of PCI to improve survival, compared with medical therapy in multivessel CAD “remains uncertain.”

Other recommendations likely to be of interest are that the radial artery is preferred, after the left internal mammary artery, as a surgical revascularization conduit over use of a saphenous vein conduit. Benefits include superior patency, fewer adverse cardiac events, and improved survival, the committee noted.

The radial artery is also recommended (class 1) in patients undergoing PCI who have acute coronary syndromes or stable ischemic heart disease to reduce bleeding and vascular complications compared with a femoral approach.

“Having both new radial recommendations sort of makes a bit of tension because the interventionalist is going to want to use the radial artery, but also the surgeon is too,” observed Dr. Tamis-Holland. “We see that in our own practice, so we try to have a collaborative approach to the patient to say: ‘Maybe do the cardiac cath in the dominant radial and then we can use the nondominant radial for a bypass conduit,’ but using both for each revascularization strategy will benefit the patient.

“So, we just have to remember that we’re going to talk together as a heart team and try to make the best decisions for each patient.”

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

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Clinicians should approach decisions regarding coronary revascularization based on clinical indications without an eye toward sex, race, or ethnicity, advises a joint clinical practice guideline released Dec. 8 by the American Heart Association and American College of Cardiology.

Dr. Jennifer S. Lawton

The new class 1 recommendation leads off the 109-page document and reflects evidence demonstrating that revascularization is equally beneficial for all patients. Still, studies show that women and non-White patients are less likely to receive reperfusion therapy or revascularization.

“This was extremely important to all the committee members because of all of the disparities that have been documented not only in diagnosis but [in] the care provided to underrepresented minorities, women, and other ethnic groups,” said Jennifer S. Lawton, MD, chief of cardiac surgery at Johns Hopkins University, Baltimore, and guideline writing committee chair.  

“We wanted to make it clear right at the beginning of the document that these guidelines apply to everyone, and we want it to be known that care should be the same for everyone,” she said in an interview.

The guideline was simultaneously published Dec. 9, 2021, in the journal  Circulation  and the  Journal of the American College of Cardiology

It updates and consolidates the ACC/AHA 2011 coronary artery bypass surgery (CABG) guideline and the ACC/AHA/Society for Cardiovascular Angiography and Interventions 2011 and 2015 percutaneous coronary intervention (PCI) guidelines.

The new document emphasizes in a class 1 recommendation the importance of the multidisciplinary heart team in patients with coronary artery disease (CAD) where the best treatment strategy is unclear. But it also stresses that treatment decisions should be patient centered – taking into account patient preferences and goals, cultural beliefs, health literacy, and social determinants of cardiovascular health – and made in collaboration with the patient’s support system.

“Oftentimes we recommend a strategy of revascularization that may not be what the patient wants or hasn’t taken into account the patient’s preferences and also the family members,” Dr. Lawson said. “So we felt that was very important.”

Patients should also be provided with available evidence for various treatment options, including risks and benefits of each option, for informed consent. The two new class 1 recommendations are highlighted in a figure illustrating the shared decision-making algorithm that, by design, features a female clinician and Black patient.

“We spent 2 years debating the best revascularization strategies and we’re considered experts in the field – but when we talk to our patients, they really don’t know the benefits and risks,” she said. “In order to translate it to the layperson in basic terms, it’s important to say, ‘If you choose this option, you will likely live longer’ rather than using the jargon.”
 

DAPT, staged PCI, stable IHD

Among the top 10 take-home messages highlighted by the authors is a 2a recommendation that 1-3 months of dual antiplatelet therapy (DAPT) after PCI with a transition to P2Y12 inhibitor monotherapy is “reasonable” in selected patients to reduce the risk of bleeding events. Previous recommendations called for 6 or 12 months of DAPT.

enot-poloskun/Getty Images

“We really respect all of the clinical trials that came out showing that a shorter duration of DAPT is not inferior in terms of ischemic events but less bleeding, yet I don’t know how many clinicians are actually just using 3 months of DAPT followed by P2Y12 monotherapy,” guideline committee vice chair Jacqueline Tamis-Holland, MD, professor of medicine, Icahn School of Medicine at Mount Sinai, New York, said in an interview. “So while it’s not a big, glaring giant recommendation, I think it will change a lot of practice.”

Similarly, she suggested that practice may shift as a result of a class 1 recommendation for staged PCI of a significantly stenosed nonculprit artery to reduce the risk for death or MI in selected hemodynamically stable patients presenting with ST-segment elevation MI and multivessel disease. “When you survey physicians, 75% of them do staged PCI but I think there will probably be more of an approach to staged PCI, as opposed to doing multivessel PCI at the time of primary PCI.”

Newer evidence from meta-analyses and the landmark ISCHEMIA trial showing no advantage of CABG over medical therapy in stable ischemic heart disease is reflected in a new class 2b recommendation – downgraded from class 1 in 2011 – that CABG “may be reasonable” to improve survival in stable patients with triple-vessel CAD.

The writing committee concluded that the ability of PCI to improve survival, compared with medical therapy in multivessel CAD “remains uncertain.”

Other recommendations likely to be of interest are that the radial artery is preferred, after the left internal mammary artery, as a surgical revascularization conduit over use of a saphenous vein conduit. Benefits include superior patency, fewer adverse cardiac events, and improved survival, the committee noted.

The radial artery is also recommended (class 1) in patients undergoing PCI who have acute coronary syndromes or stable ischemic heart disease to reduce bleeding and vascular complications compared with a femoral approach.

“Having both new radial recommendations sort of makes a bit of tension because the interventionalist is going to want to use the radial artery, but also the surgeon is too,” observed Dr. Tamis-Holland. “We see that in our own practice, so we try to have a collaborative approach to the patient to say: ‘Maybe do the cardiac cath in the dominant radial and then we can use the nondominant radial for a bypass conduit,’ but using both for each revascularization strategy will benefit the patient.

“So, we just have to remember that we’re going to talk together as a heart team and try to make the best decisions for each patient.”

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

Clinicians should approach decisions regarding coronary revascularization based on clinical indications without an eye toward sex, race, or ethnicity, advises a joint clinical practice guideline released Dec. 8 by the American Heart Association and American College of Cardiology.

Dr. Jennifer S. Lawton

The new class 1 recommendation leads off the 109-page document and reflects evidence demonstrating that revascularization is equally beneficial for all patients. Still, studies show that women and non-White patients are less likely to receive reperfusion therapy or revascularization.

“This was extremely important to all the committee members because of all of the disparities that have been documented not only in diagnosis but [in] the care provided to underrepresented minorities, women, and other ethnic groups,” said Jennifer S. Lawton, MD, chief of cardiac surgery at Johns Hopkins University, Baltimore, and guideline writing committee chair.  

“We wanted to make it clear right at the beginning of the document that these guidelines apply to everyone, and we want it to be known that care should be the same for everyone,” she said in an interview.

The guideline was simultaneously published Dec. 9, 2021, in the journal  Circulation  and the  Journal of the American College of Cardiology

It updates and consolidates the ACC/AHA 2011 coronary artery bypass surgery (CABG) guideline and the ACC/AHA/Society for Cardiovascular Angiography and Interventions 2011 and 2015 percutaneous coronary intervention (PCI) guidelines.

The new document emphasizes in a class 1 recommendation the importance of the multidisciplinary heart team in patients with coronary artery disease (CAD) where the best treatment strategy is unclear. But it also stresses that treatment decisions should be patient centered – taking into account patient preferences and goals, cultural beliefs, health literacy, and social determinants of cardiovascular health – and made in collaboration with the patient’s support system.

“Oftentimes we recommend a strategy of revascularization that may not be what the patient wants or hasn’t taken into account the patient’s preferences and also the family members,” Dr. Lawson said. “So we felt that was very important.”

Patients should also be provided with available evidence for various treatment options, including risks and benefits of each option, for informed consent. The two new class 1 recommendations are highlighted in a figure illustrating the shared decision-making algorithm that, by design, features a female clinician and Black patient.

“We spent 2 years debating the best revascularization strategies and we’re considered experts in the field – but when we talk to our patients, they really don’t know the benefits and risks,” she said. “In order to translate it to the layperson in basic terms, it’s important to say, ‘If you choose this option, you will likely live longer’ rather than using the jargon.”
 

DAPT, staged PCI, stable IHD

Among the top 10 take-home messages highlighted by the authors is a 2a recommendation that 1-3 months of dual antiplatelet therapy (DAPT) after PCI with a transition to P2Y12 inhibitor monotherapy is “reasonable” in selected patients to reduce the risk of bleeding events. Previous recommendations called for 6 or 12 months of DAPT.

enot-poloskun/Getty Images

“We really respect all of the clinical trials that came out showing that a shorter duration of DAPT is not inferior in terms of ischemic events but less bleeding, yet I don’t know how many clinicians are actually just using 3 months of DAPT followed by P2Y12 monotherapy,” guideline committee vice chair Jacqueline Tamis-Holland, MD, professor of medicine, Icahn School of Medicine at Mount Sinai, New York, said in an interview. “So while it’s not a big, glaring giant recommendation, I think it will change a lot of practice.”

Similarly, she suggested that practice may shift as a result of a class 1 recommendation for staged PCI of a significantly stenosed nonculprit artery to reduce the risk for death or MI in selected hemodynamically stable patients presenting with ST-segment elevation MI and multivessel disease. “When you survey physicians, 75% of them do staged PCI but I think there will probably be more of an approach to staged PCI, as opposed to doing multivessel PCI at the time of primary PCI.”

Newer evidence from meta-analyses and the landmark ISCHEMIA trial showing no advantage of CABG over medical therapy in stable ischemic heart disease is reflected in a new class 2b recommendation – downgraded from class 1 in 2011 – that CABG “may be reasonable” to improve survival in stable patients with triple-vessel CAD.

The writing committee concluded that the ability of PCI to improve survival, compared with medical therapy in multivessel CAD “remains uncertain.”

Other recommendations likely to be of interest are that the radial artery is preferred, after the left internal mammary artery, as a surgical revascularization conduit over use of a saphenous vein conduit. Benefits include superior patency, fewer adverse cardiac events, and improved survival, the committee noted.

The radial artery is also recommended (class 1) in patients undergoing PCI who have acute coronary syndromes or stable ischemic heart disease to reduce bleeding and vascular complications compared with a femoral approach.

“Having both new radial recommendations sort of makes a bit of tension because the interventionalist is going to want to use the radial artery, but also the surgeon is too,” observed Dr. Tamis-Holland. “We see that in our own practice, so we try to have a collaborative approach to the patient to say: ‘Maybe do the cardiac cath in the dominant radial and then we can use the nondominant radial for a bypass conduit,’ but using both for each revascularization strategy will benefit the patient.

“So, we just have to remember that we’re going to talk together as a heart team and try to make the best decisions for each patient.”

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

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Updated ACG GERD guideline addresses increased scrutiny of PPI therapy

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For the first time since 2013, the American College of Gastroenterology has issued updated evidence-based recommendations and practical guidance on the evaluation and management of gastroesophageal reflux disease (GERD), including pharmacologic, lifestyle, surgical, and endoscopic management.

Over the past 8 years, understanding of the varied presentations of GERD, enhancements in diagnostic testing, and approach to patient management have evolved, and there has been closer scrutiny of proton pump inhibitor (PPI) therapy and its potential side effects, the guideline authors said.

While PPIs remain the “medical treatment of choice” for GERD, multiple studies have raised questions about adverse events, they noted.

“We now know a lot more about PPI adverse events in the sense that we have another 8 years of experience” since the 2013 guideline, first author Philip O. Katz, MD, professor of medicine and director of motility laboratories at Weill Cornell Medicine, New York, added in an interview.

This update emphasizes the importance of making an accurate diagnosis and recommends PPI therapy “when patients really have GERD and being careful to use the lowest effective dose,” Dr. Katz said.

The guideline was published online Nov. 22, 2021, in the American Journal of Gastroenterology.
 

Benefits outweigh risks

The guideline suggests telling patients that PPIs are the most effective medical treatment for GERD.

Some studies have identified an association between the long-term use of PPIs and the development of several adverse conditions, including intestinal infections, pneumonia, stomach cancer, osteoporosis-related bone fractures, chronic kidney disease, deficiencies of certain vitamins and minerals, heart attacks, strokes, dementia, and early death.

Clinicians should emphasize, however, that these studies have flaws, are not considered definitive, and do not establish a cause-and-effect relationship between PPIs and the adverse conditions.

They should also emphasize to patients that high-quality studies have found that PPIs do not significantly raise the risk of any of these conditions except intestinal infections.

Patients should be told that, for the treatment of GERD, “gastroenterologists generally agree that the well-established benefits of PPIs far outweigh their theoretical risks.”

“Everything in this guideline makes sense,” Scott Gabbard, MD, gastroenterologist and section head, Center for Neurogastroenterology and Motility, Cleveland Clinic, who wasn’t involved in the guideline development, said in an interview.

“A PPI trial for anyone with typical GERD symptoms and having those who respond taper to the lowest effective dose is still the first line for anyone with GERD,” Dr. Gabbard said.
 

Making the diagnosis

As there is currently no gold standard for the diagnosis of GERD, diagnosis is based on a combination of symptoms, endoscopic evaluation of esophageal mucosa, reflux monitoring, and response to therapeutic intervention, the guideline says.

For patients with classic symptoms of heartburn and regurgitation with no alarm symptoms, the authors recommend an 8-week trial of empiric once-daily PPIs before a meal. If the patient responds, the guideline recommends attempting to discontinue the medication.

The guideline recommends diagnostic endoscopy after PPIs are stopped for 2-4 weeks in patients whose classic symptoms fail to respond adequately to the 8-week empiric PPI trial or in those whose symptoms return when PPIs are discontinued.

For patients with chest pain but no heartburn who have undergone an adequate evaluation to exclude heart disease, the guideline advises objective testing for GERD (endoscopy and/or reflux monitoring).

The use of barium swallow solely as a diagnostic test for GERD is not recommended.

Endoscopy should be the first test for evaluating patients presenting with dysphagia or other alarm symptoms, such as weight loss and gastrointestinal bleeding, as well as for patients with risk factors for Barrett’s esophagus.

For patients in whom the diagnosis of GERD is suspected but unclear and endoscopy fails to show objective evidence of GERD, the guidelines advise reflux monitoring off therapy to establish the diagnosis.

The guideline recommends against reflux monitoring off therapy solely as a diagnostic test for GERD in patients with known endoscopic evidence of Los Angeles grade C or D reflux esophagitis or in patients with long-segment Barrett’s esophagus.

High-resolution manometry solely as a diagnostic test for GERD is also not recommended.
 

 

 

Medical management of GERD

Recommendations for medical management of GERD include weight loss in patients who are overweight or obese, avoidance of meals within 2-3 hours of bedtime, avoidance of tobacco products and “trigger foods,” and elevation of the head of the bed for nighttime symptoms.

Treatment with a PPI is recommended over histamine2-receptor antagonists for healing and maintenance of healing of eosinophilic esophagitis. Taking a PPI 30-60 minutes prior to a meal rather than at bedtime is recommended.

“Use of the lowest effective PPI dose is recommended and logical but must be individualized,” the guideline states.

There is “conceptual rationale” for a trial of switching PPIs for patients who don’t respond to one PPI. However, switching more than once to another PPI “cannot be supported,” the guideline says.

Dr. Gabbard said the advice about switching PPIs in nonresponders is particularly helpful.

“In clinical practice, I see patients who try one PPI, and if it doesn’t work, their doctor puts them on another PPI, then another and another, until they get through five PPIs and gotten nowhere,” he said in an interview.

“This new guideline is very helpful in saying, if a patient has GERD symptoms that do not respond to a PPI, you can do one switch. But, if that doesn’t work, have a low threshold to perform pH testing to determine if the patient truly has reflux or not,” Dr. Gabbard said.

“Some studies have suggested that up to 75% of PPI nonresponders actually don’t have reflux. They have functional heartburn, which is not reflux and is treated without PPIs,” he noted.

One area of controversy relates to abrupt PPI discontinuation and potential rebound acid hypersecretion, resulting in increased reflux symptoms. While this has been found in healthy control patients, strong evidence for an increase in symptoms after abrupt PPI withdrawal is lacking.

The guideline makes “no definitive recommendation as to whether weaning or stopping PPIs cold turkey is a better approach, due to a lack of evidence,” Dr. Katz said in an interview.

For patients with GERD without erosive esophagitis or Barrett’s esophagus and whose symptoms resolve with PPI therapy, the guideline says an attempt should be made to discontinue PPI therapy or to switch to on-demand therapy in which a PPI is taken only when symptoms occur and is stopped when they are relieved.

For patients with Los Angeles grade C or D esophagitis, the recommendation is for maintenance PPI therapy indefinitely or antireflux surgery.

Dr. Gabbard said it’s “nice to have in writing from the ACG that patients with erosive esophagitis or Barrett’s esophagus – those who truly need a PPI – should be on indefinite PPI therapy, because the benefit of a PPI far outweighs the theoretical risks.”

The research had no financial support. Dr. Katz has served as consultant for Phathom Pharma and Medtronic, has received research support from Diversatek and royalties from UpToDate, and serves on the Medscape Gastroenterology advisory board. Dr. Gabbard disclosed no relevant financial relationships.

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

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For the first time since 2013, the American College of Gastroenterology has issued updated evidence-based recommendations and practical guidance on the evaluation and management of gastroesophageal reflux disease (GERD), including pharmacologic, lifestyle, surgical, and endoscopic management.

Over the past 8 years, understanding of the varied presentations of GERD, enhancements in diagnostic testing, and approach to patient management have evolved, and there has been closer scrutiny of proton pump inhibitor (PPI) therapy and its potential side effects, the guideline authors said.

While PPIs remain the “medical treatment of choice” for GERD, multiple studies have raised questions about adverse events, they noted.

“We now know a lot more about PPI adverse events in the sense that we have another 8 years of experience” since the 2013 guideline, first author Philip O. Katz, MD, professor of medicine and director of motility laboratories at Weill Cornell Medicine, New York, added in an interview.

This update emphasizes the importance of making an accurate diagnosis and recommends PPI therapy “when patients really have GERD and being careful to use the lowest effective dose,” Dr. Katz said.

The guideline was published online Nov. 22, 2021, in the American Journal of Gastroenterology.
 

Benefits outweigh risks

The guideline suggests telling patients that PPIs are the most effective medical treatment for GERD.

Some studies have identified an association between the long-term use of PPIs and the development of several adverse conditions, including intestinal infections, pneumonia, stomach cancer, osteoporosis-related bone fractures, chronic kidney disease, deficiencies of certain vitamins and minerals, heart attacks, strokes, dementia, and early death.

Clinicians should emphasize, however, that these studies have flaws, are not considered definitive, and do not establish a cause-and-effect relationship between PPIs and the adverse conditions.

They should also emphasize to patients that high-quality studies have found that PPIs do not significantly raise the risk of any of these conditions except intestinal infections.

Patients should be told that, for the treatment of GERD, “gastroenterologists generally agree that the well-established benefits of PPIs far outweigh their theoretical risks.”

“Everything in this guideline makes sense,” Scott Gabbard, MD, gastroenterologist and section head, Center for Neurogastroenterology and Motility, Cleveland Clinic, who wasn’t involved in the guideline development, said in an interview.

“A PPI trial for anyone with typical GERD symptoms and having those who respond taper to the lowest effective dose is still the first line for anyone with GERD,” Dr. Gabbard said.
 

Making the diagnosis

As there is currently no gold standard for the diagnosis of GERD, diagnosis is based on a combination of symptoms, endoscopic evaluation of esophageal mucosa, reflux monitoring, and response to therapeutic intervention, the guideline says.

For patients with classic symptoms of heartburn and regurgitation with no alarm symptoms, the authors recommend an 8-week trial of empiric once-daily PPIs before a meal. If the patient responds, the guideline recommends attempting to discontinue the medication.

The guideline recommends diagnostic endoscopy after PPIs are stopped for 2-4 weeks in patients whose classic symptoms fail to respond adequately to the 8-week empiric PPI trial or in those whose symptoms return when PPIs are discontinued.

For patients with chest pain but no heartburn who have undergone an adequate evaluation to exclude heart disease, the guideline advises objective testing for GERD (endoscopy and/or reflux monitoring).

The use of barium swallow solely as a diagnostic test for GERD is not recommended.

Endoscopy should be the first test for evaluating patients presenting with dysphagia or other alarm symptoms, such as weight loss and gastrointestinal bleeding, as well as for patients with risk factors for Barrett’s esophagus.

For patients in whom the diagnosis of GERD is suspected but unclear and endoscopy fails to show objective evidence of GERD, the guidelines advise reflux monitoring off therapy to establish the diagnosis.

The guideline recommends against reflux monitoring off therapy solely as a diagnostic test for GERD in patients with known endoscopic evidence of Los Angeles grade C or D reflux esophagitis or in patients with long-segment Barrett’s esophagus.

High-resolution manometry solely as a diagnostic test for GERD is also not recommended.
 

 

 

Medical management of GERD

Recommendations for medical management of GERD include weight loss in patients who are overweight or obese, avoidance of meals within 2-3 hours of bedtime, avoidance of tobacco products and “trigger foods,” and elevation of the head of the bed for nighttime symptoms.

Treatment with a PPI is recommended over histamine2-receptor antagonists for healing and maintenance of healing of eosinophilic esophagitis. Taking a PPI 30-60 minutes prior to a meal rather than at bedtime is recommended.

“Use of the lowest effective PPI dose is recommended and logical but must be individualized,” the guideline states.

There is “conceptual rationale” for a trial of switching PPIs for patients who don’t respond to one PPI. However, switching more than once to another PPI “cannot be supported,” the guideline says.

Dr. Gabbard said the advice about switching PPIs in nonresponders is particularly helpful.

“In clinical practice, I see patients who try one PPI, and if it doesn’t work, their doctor puts them on another PPI, then another and another, until they get through five PPIs and gotten nowhere,” he said in an interview.

“This new guideline is very helpful in saying, if a patient has GERD symptoms that do not respond to a PPI, you can do one switch. But, if that doesn’t work, have a low threshold to perform pH testing to determine if the patient truly has reflux or not,” Dr. Gabbard said.

“Some studies have suggested that up to 75% of PPI nonresponders actually don’t have reflux. They have functional heartburn, which is not reflux and is treated without PPIs,” he noted.

One area of controversy relates to abrupt PPI discontinuation and potential rebound acid hypersecretion, resulting in increased reflux symptoms. While this has been found in healthy control patients, strong evidence for an increase in symptoms after abrupt PPI withdrawal is lacking.

The guideline makes “no definitive recommendation as to whether weaning or stopping PPIs cold turkey is a better approach, due to a lack of evidence,” Dr. Katz said in an interview.

For patients with GERD without erosive esophagitis or Barrett’s esophagus and whose symptoms resolve with PPI therapy, the guideline says an attempt should be made to discontinue PPI therapy or to switch to on-demand therapy in which a PPI is taken only when symptoms occur and is stopped when they are relieved.

For patients with Los Angeles grade C or D esophagitis, the recommendation is for maintenance PPI therapy indefinitely or antireflux surgery.

Dr. Gabbard said it’s “nice to have in writing from the ACG that patients with erosive esophagitis or Barrett’s esophagus – those who truly need a PPI – should be on indefinite PPI therapy, because the benefit of a PPI far outweighs the theoretical risks.”

The research had no financial support. Dr. Katz has served as consultant for Phathom Pharma and Medtronic, has received research support from Diversatek and royalties from UpToDate, and serves on the Medscape Gastroenterology advisory board. Dr. Gabbard disclosed no relevant financial relationships.

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

 

For the first time since 2013, the American College of Gastroenterology has issued updated evidence-based recommendations and practical guidance on the evaluation and management of gastroesophageal reflux disease (GERD), including pharmacologic, lifestyle, surgical, and endoscopic management.

Over the past 8 years, understanding of the varied presentations of GERD, enhancements in diagnostic testing, and approach to patient management have evolved, and there has been closer scrutiny of proton pump inhibitor (PPI) therapy and its potential side effects, the guideline authors said.

While PPIs remain the “medical treatment of choice” for GERD, multiple studies have raised questions about adverse events, they noted.

“We now know a lot more about PPI adverse events in the sense that we have another 8 years of experience” since the 2013 guideline, first author Philip O. Katz, MD, professor of medicine and director of motility laboratories at Weill Cornell Medicine, New York, added in an interview.

This update emphasizes the importance of making an accurate diagnosis and recommends PPI therapy “when patients really have GERD and being careful to use the lowest effective dose,” Dr. Katz said.

The guideline was published online Nov. 22, 2021, in the American Journal of Gastroenterology.
 

Benefits outweigh risks

The guideline suggests telling patients that PPIs are the most effective medical treatment for GERD.

Some studies have identified an association between the long-term use of PPIs and the development of several adverse conditions, including intestinal infections, pneumonia, stomach cancer, osteoporosis-related bone fractures, chronic kidney disease, deficiencies of certain vitamins and minerals, heart attacks, strokes, dementia, and early death.

Clinicians should emphasize, however, that these studies have flaws, are not considered definitive, and do not establish a cause-and-effect relationship between PPIs and the adverse conditions.

They should also emphasize to patients that high-quality studies have found that PPIs do not significantly raise the risk of any of these conditions except intestinal infections.

Patients should be told that, for the treatment of GERD, “gastroenterologists generally agree that the well-established benefits of PPIs far outweigh their theoretical risks.”

“Everything in this guideline makes sense,” Scott Gabbard, MD, gastroenterologist and section head, Center for Neurogastroenterology and Motility, Cleveland Clinic, who wasn’t involved in the guideline development, said in an interview.

“A PPI trial for anyone with typical GERD symptoms and having those who respond taper to the lowest effective dose is still the first line for anyone with GERD,” Dr. Gabbard said.
 

Making the diagnosis

As there is currently no gold standard for the diagnosis of GERD, diagnosis is based on a combination of symptoms, endoscopic evaluation of esophageal mucosa, reflux monitoring, and response to therapeutic intervention, the guideline says.

For patients with classic symptoms of heartburn and regurgitation with no alarm symptoms, the authors recommend an 8-week trial of empiric once-daily PPIs before a meal. If the patient responds, the guideline recommends attempting to discontinue the medication.

The guideline recommends diagnostic endoscopy after PPIs are stopped for 2-4 weeks in patients whose classic symptoms fail to respond adequately to the 8-week empiric PPI trial or in those whose symptoms return when PPIs are discontinued.

For patients with chest pain but no heartburn who have undergone an adequate evaluation to exclude heart disease, the guideline advises objective testing for GERD (endoscopy and/or reflux monitoring).

The use of barium swallow solely as a diagnostic test for GERD is not recommended.

Endoscopy should be the first test for evaluating patients presenting with dysphagia or other alarm symptoms, such as weight loss and gastrointestinal bleeding, as well as for patients with risk factors for Barrett’s esophagus.

For patients in whom the diagnosis of GERD is suspected but unclear and endoscopy fails to show objective evidence of GERD, the guidelines advise reflux monitoring off therapy to establish the diagnosis.

The guideline recommends against reflux monitoring off therapy solely as a diagnostic test for GERD in patients with known endoscopic evidence of Los Angeles grade C or D reflux esophagitis or in patients with long-segment Barrett’s esophagus.

High-resolution manometry solely as a diagnostic test for GERD is also not recommended.
 

 

 

Medical management of GERD

Recommendations for medical management of GERD include weight loss in patients who are overweight or obese, avoidance of meals within 2-3 hours of bedtime, avoidance of tobacco products and “trigger foods,” and elevation of the head of the bed for nighttime symptoms.

Treatment with a PPI is recommended over histamine2-receptor antagonists for healing and maintenance of healing of eosinophilic esophagitis. Taking a PPI 30-60 minutes prior to a meal rather than at bedtime is recommended.

“Use of the lowest effective PPI dose is recommended and logical but must be individualized,” the guideline states.

There is “conceptual rationale” for a trial of switching PPIs for patients who don’t respond to one PPI. However, switching more than once to another PPI “cannot be supported,” the guideline says.

Dr. Gabbard said the advice about switching PPIs in nonresponders is particularly helpful.

“In clinical practice, I see patients who try one PPI, and if it doesn’t work, their doctor puts them on another PPI, then another and another, until they get through five PPIs and gotten nowhere,” he said in an interview.

“This new guideline is very helpful in saying, if a patient has GERD symptoms that do not respond to a PPI, you can do one switch. But, if that doesn’t work, have a low threshold to perform pH testing to determine if the patient truly has reflux or not,” Dr. Gabbard said.

“Some studies have suggested that up to 75% of PPI nonresponders actually don’t have reflux. They have functional heartburn, which is not reflux and is treated without PPIs,” he noted.

One area of controversy relates to abrupt PPI discontinuation and potential rebound acid hypersecretion, resulting in increased reflux symptoms. While this has been found in healthy control patients, strong evidence for an increase in symptoms after abrupt PPI withdrawal is lacking.

The guideline makes “no definitive recommendation as to whether weaning or stopping PPIs cold turkey is a better approach, due to a lack of evidence,” Dr. Katz said in an interview.

For patients with GERD without erosive esophagitis or Barrett’s esophagus and whose symptoms resolve with PPI therapy, the guideline says an attempt should be made to discontinue PPI therapy or to switch to on-demand therapy in which a PPI is taken only when symptoms occur and is stopped when they are relieved.

For patients with Los Angeles grade C or D esophagitis, the recommendation is for maintenance PPI therapy indefinitely or antireflux surgery.

Dr. Gabbard said it’s “nice to have in writing from the ACG that patients with erosive esophagitis or Barrett’s esophagus – those who truly need a PPI – should be on indefinite PPI therapy, because the benefit of a PPI far outweighs the theoretical risks.”

The research had no financial support. Dr. Katz has served as consultant for Phathom Pharma and Medtronic, has received research support from Diversatek and royalties from UpToDate, and serves on the Medscape Gastroenterology advisory board. Dr. Gabbard disclosed no relevant financial relationships.

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

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FROM THE AMERICAN JOURNAL OF GASTROENTEROLOGY

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AGA Clinical Practice Update: Commentary on surveillance after ESD for dysplasia and early-stage GI cancer

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The American Gastroenterological Association recently published a Clinical Practice Update Commentary outlining surveillance strategies following endoscopic submucosal dissection (ESD) of dysplasia and early gastrointestinal cancer considered pathologically curative.

Dr. Andrew Y. Wang

The suggested practice advice, which was put together by Andrew Y. Wang, MD, of the University of Virginia, Charlottesville, and colleagues, offers timelines and modalities of surveillance based on neoplasia type and location, with accompanying summaries of relevant literature.

“Long-term U.S. data about ESD outcomes for early GI neoplasia are only beginning to emerge,” the authors wrote in Gastroenterology. “As such, the current clinical practice regarding endoscopic surveillance intervals and the need for other testing (such as radiographic imaging) after ESD considered curative by histopathology is extrapolated from data derived from Asia and other countries, from concepts learned from polypectomy and piecemeal endoscopic mucosal resection (EMR), and from guideline recommendations after local surgical resection.”

The authors went on to suggest that current recommendations for post-ESD surveillance, including international guidelines “are based more so on expert opinion than rigorous evidence.”

The present update was written to offer additional clarity in this area by providing “a reasonable framework for clinical care and launch points for future research to refine and standardize optimal post-ESD surveillance strategies.”

Foremost, Dr. Wang and colleagues suggested that post-ESD surveillance is necessary because of a lack of standardization concerning the definition of complete resection, along with variable standards of pathological assessment in Western countries, compared with Japan, where pathologists use 2-3 mm serial sectioning and special stains to detect lymphovascular invasion, “which is essential to accurate histopathologic diagnosis and determination of curative resection.”

According to the authors, surveillance endoscopy should be performed with a high-definition endoscope augmented with dye-based or electronic chromoendoscopy, and ideally with optimal magnification.

“Although no supporting data are available at this time, it is prudent and may be reasonable to obtain central and peripheral biopsies of the post-ESD scar,” the authors wrote, noting that relevant mucosa should be checked for metachronous lesions.
 

Esophageal dysplasia and esophageal squamous cell carcinoma

Following curative resection of low-grade or high-grade esophageal squamous dysplasia, the authors suggested follow-up esophagogastroduodenoscopy (EGD) initially at intervals of 6-12 months, while advising against endoscopic ultrasonography and radiographic surveillance.

In contrast, Dr. Wang and colleagues suggested that superficial esophageal squamous cell carcinoma removed by ESD may benefit from a shorter interval of endoscopic surveillance, with a range of 3-6 months for first and second follow-up EGDs. Clinicians may also consider endoscopic ultrasonography with each EGD, plus an annual CT scan of the abdomen and chest, for 3-5 years.

“A limitation of ESD is that the at-risk esophagus is left in place, and there is a possibility of developing local recurrence or metachronous neoplasia,” the authors wrote. “Although local recurrence after ESD deemed pathologically curative of esophageal squamous cell carcinoma is infrequent, the development of metachronous lesions is not.”
 

Barrett’s dysplasia and esophageal adenocarcinoma

For all patients, curative removal of Barrett’s dysplasia or esophageal adenocarcinoma should be followed by endoscopy with mucosal ablative therapy at 2-3 months, with treatments every 2-3 months until complete eradication of intestinal metaplasia is achieved, according to Dr. Wang and colleagues.

After complete eradication, patients should be endoscopically screened from 3-12 months, depending on the degree of dysplasia or T-stage of adenocarcinoma, followed by screening procedures ranging from 6 months to 3 years, again depending on disease type.

“Endoscopic resection of visible Barrett’s neoplasia without treatment of Barrett’s esophagus has been associated with significant recurrence rates, so the objective of treatment should be endoscopic resection of visible or nodular dysplasia, followed by complete ablation of any remaining Barrett’s esophagus and associated (flat and/or invisible) dysplasia,” the authors wrote.
 

Gastric dysplasia and gastric adenocarcinoma

According to the update, after curative resection of gastric dysplasia, first follow-up endoscopy should be conducted at 6-12 months. Second follow-up should be conducted at 12 months for low-grade dysplasia versus 6-12 months for high-grade dysplasia, with annual exams thereafter.

For T1a early gastric cancer, the first two follow-up endoscopies should be performed at 6-month intervals, followed by annual exams. T1b Sm1 disease should be screened more aggressively, with 3-6 months intervals for first and second follow-up EGDs, plus CT scans of the abdomen and chest and/or endoscopic ultrasound every 6-12 months for 3-5 years.

“For lesions where a curative resection was achieved based on clinical criteria and histopathologic examination, surveillance is performed primarily to detect metachronous gastric cancers,” the authors wrote.
 

Colonic dysplasia and adenocarcinoma

According to the authors, adenomas with low-grade dysplasia or serrated sessile lesions without dysplasia removed by ESD should be rechecked by colonoscopy at 1 year and then 3 years, followed by adherence to U.S. Multi-Society Task Force recommendations.

For traditional serrated adenomas, serrated sessile lesions with dysplasia, adenomas with high-grade dysplasia, carcinoma in situ, intramucosal carcinoma, or dysplasia in the setting of inflammatory bowel disease, first follow-up colonoscopy should be conducted at 6-12 months, 1 year later, then 3 years after that, followed by reversion to USMSTF recommendations, although patients with IBD may benefit from annual colonoscopy.

Finally, patients with superficial T1 colonic adenocarcinoma should be screened more frequently, with colonoscopies at 3-6 months, 6 months, and 1 year, followed by adherence to USMSTF recommendations.

“The current Japanese guideline suggests that recurrence or metastasis after endoscopic resection of T1 (Sm) colonic carcinomas occurs mainly within 3-5 years,” the authors noted.
 

Rectal dysplasia and adenocarcinoma

Best practice advice suggestions for rectal dysplasia and adenocarcinoma are grouped similarly to the above advice for colonic lesions.

For lower-grade lesions, first follow-up with flexible sigmoidoscopy is suggested after 1 year, then 3 years, followed by reversion to USMSTF recommendations. Higher-grade dysplastic lesions should be checked after 6-12 months, 1 year, then 3 years, followed by adherence to USMSTF guidance, again excluding patients with IBD, who may benefit from annual exams.

Patients with superficial T1 rectal adenocarcinoma removed by ESD deemed pathologically curative should be checked with flexible sigmoidoscopy at 3-6 months, again at 3-6 months after first sigmoidoscopy, then every 6 months for a total of 5 years from the time of ESD, followed by adherence to USMSTF recommendations. At 1 year following ESD, patients should undergo colonoscopy, which can take the place of one of the follow-up flexible sigmoidoscopy exams; if an advanced adenoma is found, colonoscopy should be repeated after 1 year, versus 3 years if no advanced adenomas are found, followed by adherence to USMSTF recommendations. Patients with superficial T1 rectal adenocarcinoma should also undergo endoscopic ultrasound or pelvic MRI with contrast every 3-6 months for 2 years, followed by intervals of 6 months for a total of 5 years. Annual CT of the chest and abdomen may also be considered for a duration of 3-5 years.

Call for research

Dr. Wang and colleagues concluded their update with a call for research.

“We acknowledge that the level of evidence currently available to support much of our surveillance advice is generally low,” they wrote. “The intent of this clinical practice update was to propose surveillance strategies after potentially curative ESD for various GI neoplasms, which might also serve as reference points to stimulate research that will refine future clinical best practice advice.”

The article was supported by the AGA. The authors disclosed relationships with MicroTech, Olympus, Lumendi, U.S. Endoscopy, Boston Scientific, Steris and others.

This article was updated Dec. 15, 2021.

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The American Gastroenterological Association recently published a Clinical Practice Update Commentary outlining surveillance strategies following endoscopic submucosal dissection (ESD) of dysplasia and early gastrointestinal cancer considered pathologically curative.

Dr. Andrew Y. Wang

The suggested practice advice, which was put together by Andrew Y. Wang, MD, of the University of Virginia, Charlottesville, and colleagues, offers timelines and modalities of surveillance based on neoplasia type and location, with accompanying summaries of relevant literature.

“Long-term U.S. data about ESD outcomes for early GI neoplasia are only beginning to emerge,” the authors wrote in Gastroenterology. “As such, the current clinical practice regarding endoscopic surveillance intervals and the need for other testing (such as radiographic imaging) after ESD considered curative by histopathology is extrapolated from data derived from Asia and other countries, from concepts learned from polypectomy and piecemeal endoscopic mucosal resection (EMR), and from guideline recommendations after local surgical resection.”

The authors went on to suggest that current recommendations for post-ESD surveillance, including international guidelines “are based more so on expert opinion than rigorous evidence.”

The present update was written to offer additional clarity in this area by providing “a reasonable framework for clinical care and launch points for future research to refine and standardize optimal post-ESD surveillance strategies.”

Foremost, Dr. Wang and colleagues suggested that post-ESD surveillance is necessary because of a lack of standardization concerning the definition of complete resection, along with variable standards of pathological assessment in Western countries, compared with Japan, where pathologists use 2-3 mm serial sectioning and special stains to detect lymphovascular invasion, “which is essential to accurate histopathologic diagnosis and determination of curative resection.”

According to the authors, surveillance endoscopy should be performed with a high-definition endoscope augmented with dye-based or electronic chromoendoscopy, and ideally with optimal magnification.

“Although no supporting data are available at this time, it is prudent and may be reasonable to obtain central and peripheral biopsies of the post-ESD scar,” the authors wrote, noting that relevant mucosa should be checked for metachronous lesions.
 

Esophageal dysplasia and esophageal squamous cell carcinoma

Following curative resection of low-grade or high-grade esophageal squamous dysplasia, the authors suggested follow-up esophagogastroduodenoscopy (EGD) initially at intervals of 6-12 months, while advising against endoscopic ultrasonography and radiographic surveillance.

In contrast, Dr. Wang and colleagues suggested that superficial esophageal squamous cell carcinoma removed by ESD may benefit from a shorter interval of endoscopic surveillance, with a range of 3-6 months for first and second follow-up EGDs. Clinicians may also consider endoscopic ultrasonography with each EGD, plus an annual CT scan of the abdomen and chest, for 3-5 years.

“A limitation of ESD is that the at-risk esophagus is left in place, and there is a possibility of developing local recurrence or metachronous neoplasia,” the authors wrote. “Although local recurrence after ESD deemed pathologically curative of esophageal squamous cell carcinoma is infrequent, the development of metachronous lesions is not.”
 

Barrett’s dysplasia and esophageal adenocarcinoma

For all patients, curative removal of Barrett’s dysplasia or esophageal adenocarcinoma should be followed by endoscopy with mucosal ablative therapy at 2-3 months, with treatments every 2-3 months until complete eradication of intestinal metaplasia is achieved, according to Dr. Wang and colleagues.

After complete eradication, patients should be endoscopically screened from 3-12 months, depending on the degree of dysplasia or T-stage of adenocarcinoma, followed by screening procedures ranging from 6 months to 3 years, again depending on disease type.

“Endoscopic resection of visible Barrett’s neoplasia without treatment of Barrett’s esophagus has been associated with significant recurrence rates, so the objective of treatment should be endoscopic resection of visible or nodular dysplasia, followed by complete ablation of any remaining Barrett’s esophagus and associated (flat and/or invisible) dysplasia,” the authors wrote.
 

Gastric dysplasia and gastric adenocarcinoma

According to the update, after curative resection of gastric dysplasia, first follow-up endoscopy should be conducted at 6-12 months. Second follow-up should be conducted at 12 months for low-grade dysplasia versus 6-12 months for high-grade dysplasia, with annual exams thereafter.

For T1a early gastric cancer, the first two follow-up endoscopies should be performed at 6-month intervals, followed by annual exams. T1b Sm1 disease should be screened more aggressively, with 3-6 months intervals for first and second follow-up EGDs, plus CT scans of the abdomen and chest and/or endoscopic ultrasound every 6-12 months for 3-5 years.

“For lesions where a curative resection was achieved based on clinical criteria and histopathologic examination, surveillance is performed primarily to detect metachronous gastric cancers,” the authors wrote.
 

Colonic dysplasia and adenocarcinoma

According to the authors, adenomas with low-grade dysplasia or serrated sessile lesions without dysplasia removed by ESD should be rechecked by colonoscopy at 1 year and then 3 years, followed by adherence to U.S. Multi-Society Task Force recommendations.

For traditional serrated adenomas, serrated sessile lesions with dysplasia, adenomas with high-grade dysplasia, carcinoma in situ, intramucosal carcinoma, or dysplasia in the setting of inflammatory bowel disease, first follow-up colonoscopy should be conducted at 6-12 months, 1 year later, then 3 years after that, followed by reversion to USMSTF recommendations, although patients with IBD may benefit from annual colonoscopy.

Finally, patients with superficial T1 colonic adenocarcinoma should be screened more frequently, with colonoscopies at 3-6 months, 6 months, and 1 year, followed by adherence to USMSTF recommendations.

“The current Japanese guideline suggests that recurrence or metastasis after endoscopic resection of T1 (Sm) colonic carcinomas occurs mainly within 3-5 years,” the authors noted.
 

Rectal dysplasia and adenocarcinoma

Best practice advice suggestions for rectal dysplasia and adenocarcinoma are grouped similarly to the above advice for colonic lesions.

For lower-grade lesions, first follow-up with flexible sigmoidoscopy is suggested after 1 year, then 3 years, followed by reversion to USMSTF recommendations. Higher-grade dysplastic lesions should be checked after 6-12 months, 1 year, then 3 years, followed by adherence to USMSTF guidance, again excluding patients with IBD, who may benefit from annual exams.

Patients with superficial T1 rectal adenocarcinoma removed by ESD deemed pathologically curative should be checked with flexible sigmoidoscopy at 3-6 months, again at 3-6 months after first sigmoidoscopy, then every 6 months for a total of 5 years from the time of ESD, followed by adherence to USMSTF recommendations. At 1 year following ESD, patients should undergo colonoscopy, which can take the place of one of the follow-up flexible sigmoidoscopy exams; if an advanced adenoma is found, colonoscopy should be repeated after 1 year, versus 3 years if no advanced adenomas are found, followed by adherence to USMSTF recommendations. Patients with superficial T1 rectal adenocarcinoma should also undergo endoscopic ultrasound or pelvic MRI with contrast every 3-6 months for 2 years, followed by intervals of 6 months for a total of 5 years. Annual CT of the chest and abdomen may also be considered for a duration of 3-5 years.

Call for research

Dr. Wang and colleagues concluded their update with a call for research.

“We acknowledge that the level of evidence currently available to support much of our surveillance advice is generally low,” they wrote. “The intent of this clinical practice update was to propose surveillance strategies after potentially curative ESD for various GI neoplasms, which might also serve as reference points to stimulate research that will refine future clinical best practice advice.”

The article was supported by the AGA. The authors disclosed relationships with MicroTech, Olympus, Lumendi, U.S. Endoscopy, Boston Scientific, Steris and others.

This article was updated Dec. 15, 2021.

The American Gastroenterological Association recently published a Clinical Practice Update Commentary outlining surveillance strategies following endoscopic submucosal dissection (ESD) of dysplasia and early gastrointestinal cancer considered pathologically curative.

Dr. Andrew Y. Wang

The suggested practice advice, which was put together by Andrew Y. Wang, MD, of the University of Virginia, Charlottesville, and colleagues, offers timelines and modalities of surveillance based on neoplasia type and location, with accompanying summaries of relevant literature.

“Long-term U.S. data about ESD outcomes for early GI neoplasia are only beginning to emerge,” the authors wrote in Gastroenterology. “As such, the current clinical practice regarding endoscopic surveillance intervals and the need for other testing (such as radiographic imaging) after ESD considered curative by histopathology is extrapolated from data derived from Asia and other countries, from concepts learned from polypectomy and piecemeal endoscopic mucosal resection (EMR), and from guideline recommendations after local surgical resection.”

The authors went on to suggest that current recommendations for post-ESD surveillance, including international guidelines “are based more so on expert opinion than rigorous evidence.”

The present update was written to offer additional clarity in this area by providing “a reasonable framework for clinical care and launch points for future research to refine and standardize optimal post-ESD surveillance strategies.”

Foremost, Dr. Wang and colleagues suggested that post-ESD surveillance is necessary because of a lack of standardization concerning the definition of complete resection, along with variable standards of pathological assessment in Western countries, compared with Japan, where pathologists use 2-3 mm serial sectioning and special stains to detect lymphovascular invasion, “which is essential to accurate histopathologic diagnosis and determination of curative resection.”

According to the authors, surveillance endoscopy should be performed with a high-definition endoscope augmented with dye-based or electronic chromoendoscopy, and ideally with optimal magnification.

“Although no supporting data are available at this time, it is prudent and may be reasonable to obtain central and peripheral biopsies of the post-ESD scar,” the authors wrote, noting that relevant mucosa should be checked for metachronous lesions.
 

Esophageal dysplasia and esophageal squamous cell carcinoma

Following curative resection of low-grade or high-grade esophageal squamous dysplasia, the authors suggested follow-up esophagogastroduodenoscopy (EGD) initially at intervals of 6-12 months, while advising against endoscopic ultrasonography and radiographic surveillance.

In contrast, Dr. Wang and colleagues suggested that superficial esophageal squamous cell carcinoma removed by ESD may benefit from a shorter interval of endoscopic surveillance, with a range of 3-6 months for first and second follow-up EGDs. Clinicians may also consider endoscopic ultrasonography with each EGD, plus an annual CT scan of the abdomen and chest, for 3-5 years.

“A limitation of ESD is that the at-risk esophagus is left in place, and there is a possibility of developing local recurrence or metachronous neoplasia,” the authors wrote. “Although local recurrence after ESD deemed pathologically curative of esophageal squamous cell carcinoma is infrequent, the development of metachronous lesions is not.”
 

Barrett’s dysplasia and esophageal adenocarcinoma

For all patients, curative removal of Barrett’s dysplasia or esophageal adenocarcinoma should be followed by endoscopy with mucosal ablative therapy at 2-3 months, with treatments every 2-3 months until complete eradication of intestinal metaplasia is achieved, according to Dr. Wang and colleagues.

After complete eradication, patients should be endoscopically screened from 3-12 months, depending on the degree of dysplasia or T-stage of adenocarcinoma, followed by screening procedures ranging from 6 months to 3 years, again depending on disease type.

“Endoscopic resection of visible Barrett’s neoplasia without treatment of Barrett’s esophagus has been associated with significant recurrence rates, so the objective of treatment should be endoscopic resection of visible or nodular dysplasia, followed by complete ablation of any remaining Barrett’s esophagus and associated (flat and/or invisible) dysplasia,” the authors wrote.
 

Gastric dysplasia and gastric adenocarcinoma

According to the update, after curative resection of gastric dysplasia, first follow-up endoscopy should be conducted at 6-12 months. Second follow-up should be conducted at 12 months for low-grade dysplasia versus 6-12 months for high-grade dysplasia, with annual exams thereafter.

For T1a early gastric cancer, the first two follow-up endoscopies should be performed at 6-month intervals, followed by annual exams. T1b Sm1 disease should be screened more aggressively, with 3-6 months intervals for first and second follow-up EGDs, plus CT scans of the abdomen and chest and/or endoscopic ultrasound every 6-12 months for 3-5 years.

“For lesions where a curative resection was achieved based on clinical criteria and histopathologic examination, surveillance is performed primarily to detect metachronous gastric cancers,” the authors wrote.
 

Colonic dysplasia and adenocarcinoma

According to the authors, adenomas with low-grade dysplasia or serrated sessile lesions without dysplasia removed by ESD should be rechecked by colonoscopy at 1 year and then 3 years, followed by adherence to U.S. Multi-Society Task Force recommendations.

For traditional serrated adenomas, serrated sessile lesions with dysplasia, adenomas with high-grade dysplasia, carcinoma in situ, intramucosal carcinoma, or dysplasia in the setting of inflammatory bowel disease, first follow-up colonoscopy should be conducted at 6-12 months, 1 year later, then 3 years after that, followed by reversion to USMSTF recommendations, although patients with IBD may benefit from annual colonoscopy.

Finally, patients with superficial T1 colonic adenocarcinoma should be screened more frequently, with colonoscopies at 3-6 months, 6 months, and 1 year, followed by adherence to USMSTF recommendations.

“The current Japanese guideline suggests that recurrence or metastasis after endoscopic resection of T1 (Sm) colonic carcinomas occurs mainly within 3-5 years,” the authors noted.
 

Rectal dysplasia and adenocarcinoma

Best practice advice suggestions for rectal dysplasia and adenocarcinoma are grouped similarly to the above advice for colonic lesions.

For lower-grade lesions, first follow-up with flexible sigmoidoscopy is suggested after 1 year, then 3 years, followed by reversion to USMSTF recommendations. Higher-grade dysplastic lesions should be checked after 6-12 months, 1 year, then 3 years, followed by adherence to USMSTF guidance, again excluding patients with IBD, who may benefit from annual exams.

Patients with superficial T1 rectal adenocarcinoma removed by ESD deemed pathologically curative should be checked with flexible sigmoidoscopy at 3-6 months, again at 3-6 months after first sigmoidoscopy, then every 6 months for a total of 5 years from the time of ESD, followed by adherence to USMSTF recommendations. At 1 year following ESD, patients should undergo colonoscopy, which can take the place of one of the follow-up flexible sigmoidoscopy exams; if an advanced adenoma is found, colonoscopy should be repeated after 1 year, versus 3 years if no advanced adenomas are found, followed by adherence to USMSTF recommendations. Patients with superficial T1 rectal adenocarcinoma should also undergo endoscopic ultrasound or pelvic MRI with contrast every 3-6 months for 2 years, followed by intervals of 6 months for a total of 5 years. Annual CT of the chest and abdomen may also be considered for a duration of 3-5 years.

Call for research

Dr. Wang and colleagues concluded their update with a call for research.

“We acknowledge that the level of evidence currently available to support much of our surveillance advice is generally low,” they wrote. “The intent of this clinical practice update was to propose surveillance strategies after potentially curative ESD for various GI neoplasms, which might also serve as reference points to stimulate research that will refine future clinical best practice advice.”

The article was supported by the AGA. The authors disclosed relationships with MicroTech, Olympus, Lumendi, U.S. Endoscopy, Boston Scientific, Steris and others.

This article was updated Dec. 15, 2021.

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AHA statement on impact of major life events on physical activity

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Physical activity levels may decline during major life events, and it’s important for health care professionals to encourage patients to maintain regular physical activity during times of significant changes in their lives, the American Heart Association says in a new scientific statement.

With this statement, “We hope health care providers, public health workers, and individuals understand that a major life change can lead to decreases in physical activity or increases in sedentary behavior,” writing group chair Abbi D. Lane-Cordova, PhD, said in an interview.

The statement includes “tips for screening for physical activity and talking to people about their activity during these big life events and resources that can be used by health care providers to help people achieve healthy levels of physical activity,” said Dr. Lane-Cordova, assistant professor in exercise science, Arnold School of Public Health, University of South Carolina, Columbia.

The statement was published online Dec. 1 in the journal Circulation.

The AHA Committee on Physical Activity, part of the organization’s Council on Lifestyle and Cardiometabolic Health, began discussing this topic back in 2019, Dr. Lane-Cordova explained.

“We spoke as a group about how much activity levels can change when something big happens in life, like becoming a parent or retiring. The change in activity behavior (physical activity or sedentary behavior) is important because these activity behaviors can influence heart health,” she said.

The group started work on the scientific statement in early 2020 – “and then the pandemic hit, and it seemed more important than ever to create awareness and a resource for people to help improve, or at least maintain, favorable activity behaviors when there’s a profound change or event in life,” Dr. Lane-Cordova said.
 

Some more vulnerable than others

The writing group examined data on 17 different life events or transitions and found evidence that physical activity levels may decline during nine events: beginning a new school (elementary, middle, high school, or college); a first job or career change; a marriage or civil union; pregnancy; parenting; retirement; or moving into a long-term care facility.

The authors also identified individuals who may be particularly susceptible to lower levels of physical activity in general and during important life events. They include those with lower levels of education; those who live alone; those who lack access to a safe outdoor space; Black Americans; some members of the LGBTQ+ community; and women who are pregnant and new parents.

They offer practical strategies for health care professionals to support routine physical activity levels during major life events and transitions. These include asking simple questions about how life transitions may be changing physical activity patterns and encouraging the use of wearable step trackers to monitor levels and changes.

“It’s important to maintain or improve physical activity when major life events happen, which is often a time when exercise is most needed,” Dr. Lane-Cordova said in a news release.

“Clinicians should express compassion as they ask about life transitions and initiate conversations about physical activity during life events and transitions,” the writing group advises.

The group also says its important “to look beyond the health care setting and engage organizations, communities, workplaces, faith-based communities, and assisted living facilities to promote physical activity.”

The statement provides a list of resources for individuals and health care professionals, many of which are free and online.

This research had no commercial funding. Members of the writing group have disclosed no relevant financial relationships.

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

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Physical activity levels may decline during major life events, and it’s important for health care professionals to encourage patients to maintain regular physical activity during times of significant changes in their lives, the American Heart Association says in a new scientific statement.

With this statement, “We hope health care providers, public health workers, and individuals understand that a major life change can lead to decreases in physical activity or increases in sedentary behavior,” writing group chair Abbi D. Lane-Cordova, PhD, said in an interview.

The statement includes “tips for screening for physical activity and talking to people about their activity during these big life events and resources that can be used by health care providers to help people achieve healthy levels of physical activity,” said Dr. Lane-Cordova, assistant professor in exercise science, Arnold School of Public Health, University of South Carolina, Columbia.

The statement was published online Dec. 1 in the journal Circulation.

The AHA Committee on Physical Activity, part of the organization’s Council on Lifestyle and Cardiometabolic Health, began discussing this topic back in 2019, Dr. Lane-Cordova explained.

“We spoke as a group about how much activity levels can change when something big happens in life, like becoming a parent or retiring. The change in activity behavior (physical activity or sedentary behavior) is important because these activity behaviors can influence heart health,” she said.

The group started work on the scientific statement in early 2020 – “and then the pandemic hit, and it seemed more important than ever to create awareness and a resource for people to help improve, or at least maintain, favorable activity behaviors when there’s a profound change or event in life,” Dr. Lane-Cordova said.
 

Some more vulnerable than others

The writing group examined data on 17 different life events or transitions and found evidence that physical activity levels may decline during nine events: beginning a new school (elementary, middle, high school, or college); a first job or career change; a marriage or civil union; pregnancy; parenting; retirement; or moving into a long-term care facility.

The authors also identified individuals who may be particularly susceptible to lower levels of physical activity in general and during important life events. They include those with lower levels of education; those who live alone; those who lack access to a safe outdoor space; Black Americans; some members of the LGBTQ+ community; and women who are pregnant and new parents.

They offer practical strategies for health care professionals to support routine physical activity levels during major life events and transitions. These include asking simple questions about how life transitions may be changing physical activity patterns and encouraging the use of wearable step trackers to monitor levels and changes.

“It’s important to maintain or improve physical activity when major life events happen, which is often a time when exercise is most needed,” Dr. Lane-Cordova said in a news release.

“Clinicians should express compassion as they ask about life transitions and initiate conversations about physical activity during life events and transitions,” the writing group advises.

The group also says its important “to look beyond the health care setting and engage organizations, communities, workplaces, faith-based communities, and assisted living facilities to promote physical activity.”

The statement provides a list of resources for individuals and health care professionals, many of which are free and online.

This research had no commercial funding. Members of the writing group have disclosed no relevant financial relationships.

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

Physical activity levels may decline during major life events, and it’s important for health care professionals to encourage patients to maintain regular physical activity during times of significant changes in their lives, the American Heart Association says in a new scientific statement.

With this statement, “We hope health care providers, public health workers, and individuals understand that a major life change can lead to decreases in physical activity or increases in sedentary behavior,” writing group chair Abbi D. Lane-Cordova, PhD, said in an interview.

The statement includes “tips for screening for physical activity and talking to people about their activity during these big life events and resources that can be used by health care providers to help people achieve healthy levels of physical activity,” said Dr. Lane-Cordova, assistant professor in exercise science, Arnold School of Public Health, University of South Carolina, Columbia.

The statement was published online Dec. 1 in the journal Circulation.

The AHA Committee on Physical Activity, part of the organization’s Council on Lifestyle and Cardiometabolic Health, began discussing this topic back in 2019, Dr. Lane-Cordova explained.

“We spoke as a group about how much activity levels can change when something big happens in life, like becoming a parent or retiring. The change in activity behavior (physical activity or sedentary behavior) is important because these activity behaviors can influence heart health,” she said.

The group started work on the scientific statement in early 2020 – “and then the pandemic hit, and it seemed more important than ever to create awareness and a resource for people to help improve, or at least maintain, favorable activity behaviors when there’s a profound change or event in life,” Dr. Lane-Cordova said.
 

Some more vulnerable than others

The writing group examined data on 17 different life events or transitions and found evidence that physical activity levels may decline during nine events: beginning a new school (elementary, middle, high school, or college); a first job or career change; a marriage or civil union; pregnancy; parenting; retirement; or moving into a long-term care facility.

The authors also identified individuals who may be particularly susceptible to lower levels of physical activity in general and during important life events. They include those with lower levels of education; those who live alone; those who lack access to a safe outdoor space; Black Americans; some members of the LGBTQ+ community; and women who are pregnant and new parents.

They offer practical strategies for health care professionals to support routine physical activity levels during major life events and transitions. These include asking simple questions about how life transitions may be changing physical activity patterns and encouraging the use of wearable step trackers to monitor levels and changes.

“It’s important to maintain or improve physical activity when major life events happen, which is often a time when exercise is most needed,” Dr. Lane-Cordova said in a news release.

“Clinicians should express compassion as they ask about life transitions and initiate conversations about physical activity during life events and transitions,” the writing group advises.

The group also says its important “to look beyond the health care setting and engage organizations, communities, workplaces, faith-based communities, and assisted living facilities to promote physical activity.”

The statement provides a list of resources for individuals and health care professionals, many of which are free and online.

This research had no commercial funding. Members of the writing group have disclosed no relevant financial relationships.

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

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AGA Clinical Care Pathway: Screening, diagnosis, and treatment of NAFLD and NASH

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The American Gastroenterological Association recently published a Clinical Care Pathway for screening, diagnosis, and treatment of patients with nonalcoholic fatty liver disease (NAFLD).

Recommendations are intended for a spectrum of clinical settings, including primary care, obesity medicine, gastroenterology, hepatology, and endocrinology practices, reported lead author Fasiha Kanwal, MD, of Baylor College of Medicine, Houston, and colleagues.

“Most patients with NAFLD and NASH [nonalcoholic steatohepatitis] are seen in primary care or endocrine clinics,” the authors wrote in Gastroenterology. “Although not all patients with NAFLD/NASH require secondary (i.e., hepatology) care, not knowing which patients might benefit from such care and when to refer them results in inconsistent care processes and possibly poor outcomes. Clinical Care Pathways, with careful explication of each step in screening, diagnosis, and treatment, have been shown to improve the quality of health care delivery in other areas of medicine, [and] are crucial to addressing the often inconsistent care processes characterizing current approaches to NAFLD/NASH.”

The guidance was drafted by a group of 15 multidisciplinary experts from around the world representing the AGA, the American Diabetes Association, the American Osteopathic Association, the Obesity Society, and the Endocrine Society. Recommendations were based on available literature and clinical experience.

The authors recommended a four-step screening process for NAFLD/NASH: Check for risk factors predicting clinically relevant fibrosis (stage F2 or higher), review history and perform relevant laboratory tests, conduct noninvasive liver fibrosis testing, and measure liver stiffness.

Patients at greatest risk for clinically significant fibrosis include those with two or more metabolic risk factors, those with type 2 diabetes, and those with incidentally detected steatosis and/or elevated aminotransferases.

“A recent retrospective cohort study found that patients with hepatic steatosis and elevated alanine aminotransferase had a significantly higher risk of progression to cirrhosis or hepatocellular carcinoma than patients with hepatic steatosis and persistently normal alanine aminotransferase,” the authors noted.

When any of the above risk factors are present, the authors recommended checking the patient’s history for excessive alcohol intake, conducting a complete blood count and liver function tests, and screening for other hepatic and biliary diseases, such as chronic hepatitis C virus infection and liver mass lesions.

If other liver diseases have been ruled out, the first step in liver fibrosis risk stratification involves noninvasive testing, with the authors favoring the Fibrosis-4 (FIB-4) score “because it has been shown to have the best diagnostic accuracy for advanced fibrosis, compared with other noninvasive markers of fibrosis in patients with NAFLD.”

The next step in risk stratification involves liver stiffness measurement (LSM) with FibroScan (vibration controlled transient elastography [VCTE]), or newer modalities, such as bidimensional shear wave elastography or point shear wave elastography, which offer “diagnostic performances at least as good as VCTE.”

According to the publication, patients with NAFLD at low risk of advanced fibrosis (FIB-4 less than 1.3 or LSM less than 8 kPa or liver biopsy F0-F1) can be managed by one provider, such as a primary care provider or endocrinologist, whereas indeterminate-risk patients (FIB-4 of 1.3-2.67 and/or LSM 8-12 kPa and liver biopsy unavailable) and high-risk patients (FIB-4 greater than 2.67 or LSM greater than 12 kPa or liver biopsy F2-F4) should be managed by a multidisciplinary team led by a hepatologist.

Lifestyle intervention, weight loss (if overweight or obese), and cardiovascular disease risk reduction are advised for patients of all risk categories.

“There are no large, long-term behavioral modification or pharmacotherapy studies regarding weight loss in individuals with NAFLD,” the authors wrote. “However, weight loss of any magnitude should be encouraged as beneficial.”

For patients with indeterminate and high risk, NASH pharmacotherapy is recommended, and if needed, diabetes care should involve medications with efficacy in NASH, such as pioglitazone.

“Although we recognize that knowledge is continuing to evolve and that recommendations may change accordingly over time, we believe this Pathway provides accessible, standardized, evidence-based, timely, and testable recommendations that will allow clinicians to care for a rapidly growing population of patients, most of whom are managed in primary care or endocrine clinics,” the authors concluded.

The article was supported by the American Gastroenterological Association, Intercept Pharmaceuticals, Pfizer, and others. The authors disclosed relationships with Novo Nordisk, Eli Lilly, Sanofi, and others.

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The American Gastroenterological Association recently published a Clinical Care Pathway for screening, diagnosis, and treatment of patients with nonalcoholic fatty liver disease (NAFLD).

Recommendations are intended for a spectrum of clinical settings, including primary care, obesity medicine, gastroenterology, hepatology, and endocrinology practices, reported lead author Fasiha Kanwal, MD, of Baylor College of Medicine, Houston, and colleagues.

“Most patients with NAFLD and NASH [nonalcoholic steatohepatitis] are seen in primary care or endocrine clinics,” the authors wrote in Gastroenterology. “Although not all patients with NAFLD/NASH require secondary (i.e., hepatology) care, not knowing which patients might benefit from such care and when to refer them results in inconsistent care processes and possibly poor outcomes. Clinical Care Pathways, with careful explication of each step in screening, diagnosis, and treatment, have been shown to improve the quality of health care delivery in other areas of medicine, [and] are crucial to addressing the often inconsistent care processes characterizing current approaches to NAFLD/NASH.”

The guidance was drafted by a group of 15 multidisciplinary experts from around the world representing the AGA, the American Diabetes Association, the American Osteopathic Association, the Obesity Society, and the Endocrine Society. Recommendations were based on available literature and clinical experience.

The authors recommended a four-step screening process for NAFLD/NASH: Check for risk factors predicting clinically relevant fibrosis (stage F2 or higher), review history and perform relevant laboratory tests, conduct noninvasive liver fibrosis testing, and measure liver stiffness.

Patients at greatest risk for clinically significant fibrosis include those with two or more metabolic risk factors, those with type 2 diabetes, and those with incidentally detected steatosis and/or elevated aminotransferases.

“A recent retrospective cohort study found that patients with hepatic steatosis and elevated alanine aminotransferase had a significantly higher risk of progression to cirrhosis or hepatocellular carcinoma than patients with hepatic steatosis and persistently normal alanine aminotransferase,” the authors noted.

When any of the above risk factors are present, the authors recommended checking the patient’s history for excessive alcohol intake, conducting a complete blood count and liver function tests, and screening for other hepatic and biliary diseases, such as chronic hepatitis C virus infection and liver mass lesions.

If other liver diseases have been ruled out, the first step in liver fibrosis risk stratification involves noninvasive testing, with the authors favoring the Fibrosis-4 (FIB-4) score “because it has been shown to have the best diagnostic accuracy for advanced fibrosis, compared with other noninvasive markers of fibrosis in patients with NAFLD.”

The next step in risk stratification involves liver stiffness measurement (LSM) with FibroScan (vibration controlled transient elastography [VCTE]), or newer modalities, such as bidimensional shear wave elastography or point shear wave elastography, which offer “diagnostic performances at least as good as VCTE.”

According to the publication, patients with NAFLD at low risk of advanced fibrosis (FIB-4 less than 1.3 or LSM less than 8 kPa or liver biopsy F0-F1) can be managed by one provider, such as a primary care provider or endocrinologist, whereas indeterminate-risk patients (FIB-4 of 1.3-2.67 and/or LSM 8-12 kPa and liver biopsy unavailable) and high-risk patients (FIB-4 greater than 2.67 or LSM greater than 12 kPa or liver biopsy F2-F4) should be managed by a multidisciplinary team led by a hepatologist.

Lifestyle intervention, weight loss (if overweight or obese), and cardiovascular disease risk reduction are advised for patients of all risk categories.

“There are no large, long-term behavioral modification or pharmacotherapy studies regarding weight loss in individuals with NAFLD,” the authors wrote. “However, weight loss of any magnitude should be encouraged as beneficial.”

For patients with indeterminate and high risk, NASH pharmacotherapy is recommended, and if needed, diabetes care should involve medications with efficacy in NASH, such as pioglitazone.

“Although we recognize that knowledge is continuing to evolve and that recommendations may change accordingly over time, we believe this Pathway provides accessible, standardized, evidence-based, timely, and testable recommendations that will allow clinicians to care for a rapidly growing population of patients, most of whom are managed in primary care or endocrine clinics,” the authors concluded.

The article was supported by the American Gastroenterological Association, Intercept Pharmaceuticals, Pfizer, and others. The authors disclosed relationships with Novo Nordisk, Eli Lilly, Sanofi, and others.

The American Gastroenterological Association recently published a Clinical Care Pathway for screening, diagnosis, and treatment of patients with nonalcoholic fatty liver disease (NAFLD).

Recommendations are intended for a spectrum of clinical settings, including primary care, obesity medicine, gastroenterology, hepatology, and endocrinology practices, reported lead author Fasiha Kanwal, MD, of Baylor College of Medicine, Houston, and colleagues.

“Most patients with NAFLD and NASH [nonalcoholic steatohepatitis] are seen in primary care or endocrine clinics,” the authors wrote in Gastroenterology. “Although not all patients with NAFLD/NASH require secondary (i.e., hepatology) care, not knowing which patients might benefit from such care and when to refer them results in inconsistent care processes and possibly poor outcomes. Clinical Care Pathways, with careful explication of each step in screening, diagnosis, and treatment, have been shown to improve the quality of health care delivery in other areas of medicine, [and] are crucial to addressing the often inconsistent care processes characterizing current approaches to NAFLD/NASH.”

The guidance was drafted by a group of 15 multidisciplinary experts from around the world representing the AGA, the American Diabetes Association, the American Osteopathic Association, the Obesity Society, and the Endocrine Society. Recommendations were based on available literature and clinical experience.

The authors recommended a four-step screening process for NAFLD/NASH: Check for risk factors predicting clinically relevant fibrosis (stage F2 or higher), review history and perform relevant laboratory tests, conduct noninvasive liver fibrosis testing, and measure liver stiffness.

Patients at greatest risk for clinically significant fibrosis include those with two or more metabolic risk factors, those with type 2 diabetes, and those with incidentally detected steatosis and/or elevated aminotransferases.

“A recent retrospective cohort study found that patients with hepatic steatosis and elevated alanine aminotransferase had a significantly higher risk of progression to cirrhosis or hepatocellular carcinoma than patients with hepatic steatosis and persistently normal alanine aminotransferase,” the authors noted.

When any of the above risk factors are present, the authors recommended checking the patient’s history for excessive alcohol intake, conducting a complete blood count and liver function tests, and screening for other hepatic and biliary diseases, such as chronic hepatitis C virus infection and liver mass lesions.

If other liver diseases have been ruled out, the first step in liver fibrosis risk stratification involves noninvasive testing, with the authors favoring the Fibrosis-4 (FIB-4) score “because it has been shown to have the best diagnostic accuracy for advanced fibrosis, compared with other noninvasive markers of fibrosis in patients with NAFLD.”

The next step in risk stratification involves liver stiffness measurement (LSM) with FibroScan (vibration controlled transient elastography [VCTE]), or newer modalities, such as bidimensional shear wave elastography or point shear wave elastography, which offer “diagnostic performances at least as good as VCTE.”

According to the publication, patients with NAFLD at low risk of advanced fibrosis (FIB-4 less than 1.3 or LSM less than 8 kPa or liver biopsy F0-F1) can be managed by one provider, such as a primary care provider or endocrinologist, whereas indeterminate-risk patients (FIB-4 of 1.3-2.67 and/or LSM 8-12 kPa and liver biopsy unavailable) and high-risk patients (FIB-4 greater than 2.67 or LSM greater than 12 kPa or liver biopsy F2-F4) should be managed by a multidisciplinary team led by a hepatologist.

Lifestyle intervention, weight loss (if overweight or obese), and cardiovascular disease risk reduction are advised for patients of all risk categories.

“There are no large, long-term behavioral modification or pharmacotherapy studies regarding weight loss in individuals with NAFLD,” the authors wrote. “However, weight loss of any magnitude should be encouraged as beneficial.”

For patients with indeterminate and high risk, NASH pharmacotherapy is recommended, and if needed, diabetes care should involve medications with efficacy in NASH, such as pioglitazone.

“Although we recognize that knowledge is continuing to evolve and that recommendations may change accordingly over time, we believe this Pathway provides accessible, standardized, evidence-based, timely, and testable recommendations that will allow clinicians to care for a rapidly growing population of patients, most of whom are managed in primary care or endocrine clinics,” the authors concluded.

The article was supported by the American Gastroenterological Association, Intercept Pharmaceuticals, Pfizer, and others. The authors disclosed relationships with Novo Nordisk, Eli Lilly, Sanofi, and others.

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AGA Clinical Practice Update: Managing pain in gut-brain interaction disorders

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Mon, 11/08/2021 - 16:13

An American Gastroenterological Association clinical practice update for gastrointestinal pain in disorders of gut-brain interaction (DGBI), published in Clinical Gastroenterology and Hepatology, emphasizes patient-physician collaboration and improvement of patient understanding of the pathways and mechanisms of pain sensations. It is aimed at management of patients in whom pain persists after first-line therapies fail to resolve visceral causes of pain.

DGBIs include irritable bowel syndrome, functional dyspepsia, and centrally mediated abdominal pain syndrome, according to Laurie Keefer, PhD, AGAF, of the division of gastroenterology at Icahn School of Medicine at Mount Sinai, New York, and colleagues. Initial treatment usually focuses on visceral triggers of pain such as food and bowel movements, but this approach is ineffective for many.

Cognitive, affective, and behavioral factors can impact the treatment of these patients, making it a complex clinical problem that calls for a collaborative approach between the patient and clinician. Opioids and other drugs that could be misused should be avoided, according to the authors. Both pharmacologic and nonpharmacologic approaches can be considered, but the update did not address use of marijuana or other complementary or alternative therapies.

Effective management requires empathy and collaboration. The patient has often seen various other clinicians with suboptimal results, which has left them dissatisfied with their care. Cultural sensitivity is crucial because the understanding and interpretation of pain, and preferred management approaches, vary across cultures.

The first step is a nonjudgmental patient history using open-ended questions. Examples include: “How do your symptoms interfere with your ability to do what you want in your daily life?” or “How are these symptoms impacting your life the most?” These types of questions may identify patients who could benefit from behavioral health interventions.

Questions about symptom-related anxiety can improve understanding of patient concerns and offer an opportunity to address fears. Additional understanding of the patient’s perspective can come from questions like: “What do you think is causing your symptoms,” “Why are you coming to see me now?” and “What are you most concerned about with your symptoms?”

The initial assessment should ideally result in shared goals and expectations for pain management.

Providers should educate the patient about the pathogenesis of pain and how it can be modified. Pain signals can result from innocuous signals from the gut that are misinterpreted by the vigilant brain as it scans for injury or illness. That model might explain why some patients with similar diagnoses have widely differing pain experiences, and offers hope that a change in how one approaches pain might lead to improvements. Patients should be encouraged to avoid too much focus on the cause or a solution to pain, because it can interfere with acceptance of pain or, when needed, treatment.

Opioids should not be prescribed for these patients, and if they are already taking them on referral, it’s important to manage them within a multidisciplinary framework until the opioids can be discontinued. Long-term use of opioids can lead to narcotic bowel syndrome, which results in chronic and often heightened abdominal pain even with escalating opioid doses. Opioid stoppage often must be accompanied by behavioral and psychiatric therapies to ensure success.

Nonpharmacological therapies such as brain-gut psychotherapies should be brought up as potential options early in treatment, even though many patients won’t require this type of care. Early mention is likely to keep the patient more open to trying them because they’re less likely to think of it as a sign of failure or a “last-ditch” approach. Cognitive-behavioral therapy works to improve pain management skills and bolster skill deficits, with attention to pain catastrophizing, pain hypervigilance, and visceral anxiety through different techniques.

Gut-directed hypnotherapy deals with somatic awareness and the use of imagery and suggestion to reduce pain sensations. Mindfulness-based stress reduction has been shown to be effective in inflammatory bowel disease and musculoskeletal pain syndromes. The provider should be familiar with these available methods, but should leave choice of interventions to partner mental health providers.

It’s important to distinguish between gastrointestinal pain with visceral causes and centrally mediated pain. Central sensitization can cause intermittent pain to become persistent even in the absence of ongoing peripheral causes of pain.

Peripheral acting agents affect gastrointestinal pain, and a network meta-analysis identified the top three drugs for pain relief in irritable bowel syndrome as tricyclic antidepressants, antispasmodics, and peppermint oil.

Neuromodulator drugs are an option for DGBI pain because the gut nervous system shares embryonic developmental pathways with the brain and spinal cord, which helps explains some of the benefits of low-dose antidepressants, now termed gut-brain neuromodulators. These drugs should be started at a low dose and gradually titrated according to symptom response and tolerability.

The authors have financial relationships with various pharmaceutical companies.

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An American Gastroenterological Association clinical practice update for gastrointestinal pain in disorders of gut-brain interaction (DGBI), published in Clinical Gastroenterology and Hepatology, emphasizes patient-physician collaboration and improvement of patient understanding of the pathways and mechanisms of pain sensations. It is aimed at management of patients in whom pain persists after first-line therapies fail to resolve visceral causes of pain.

DGBIs include irritable bowel syndrome, functional dyspepsia, and centrally mediated abdominal pain syndrome, according to Laurie Keefer, PhD, AGAF, of the division of gastroenterology at Icahn School of Medicine at Mount Sinai, New York, and colleagues. Initial treatment usually focuses on visceral triggers of pain such as food and bowel movements, but this approach is ineffective for many.

Cognitive, affective, and behavioral factors can impact the treatment of these patients, making it a complex clinical problem that calls for a collaborative approach between the patient and clinician. Opioids and other drugs that could be misused should be avoided, according to the authors. Both pharmacologic and nonpharmacologic approaches can be considered, but the update did not address use of marijuana or other complementary or alternative therapies.

Effective management requires empathy and collaboration. The patient has often seen various other clinicians with suboptimal results, which has left them dissatisfied with their care. Cultural sensitivity is crucial because the understanding and interpretation of pain, and preferred management approaches, vary across cultures.

The first step is a nonjudgmental patient history using open-ended questions. Examples include: “How do your symptoms interfere with your ability to do what you want in your daily life?” or “How are these symptoms impacting your life the most?” These types of questions may identify patients who could benefit from behavioral health interventions.

Questions about symptom-related anxiety can improve understanding of patient concerns and offer an opportunity to address fears. Additional understanding of the patient’s perspective can come from questions like: “What do you think is causing your symptoms,” “Why are you coming to see me now?” and “What are you most concerned about with your symptoms?”

The initial assessment should ideally result in shared goals and expectations for pain management.

Providers should educate the patient about the pathogenesis of pain and how it can be modified. Pain signals can result from innocuous signals from the gut that are misinterpreted by the vigilant brain as it scans for injury or illness. That model might explain why some patients with similar diagnoses have widely differing pain experiences, and offers hope that a change in how one approaches pain might lead to improvements. Patients should be encouraged to avoid too much focus on the cause or a solution to pain, because it can interfere with acceptance of pain or, when needed, treatment.

Opioids should not be prescribed for these patients, and if they are already taking them on referral, it’s important to manage them within a multidisciplinary framework until the opioids can be discontinued. Long-term use of opioids can lead to narcotic bowel syndrome, which results in chronic and often heightened abdominal pain even with escalating opioid doses. Opioid stoppage often must be accompanied by behavioral and psychiatric therapies to ensure success.

Nonpharmacological therapies such as brain-gut psychotherapies should be brought up as potential options early in treatment, even though many patients won’t require this type of care. Early mention is likely to keep the patient more open to trying them because they’re less likely to think of it as a sign of failure or a “last-ditch” approach. Cognitive-behavioral therapy works to improve pain management skills and bolster skill deficits, with attention to pain catastrophizing, pain hypervigilance, and visceral anxiety through different techniques.

Gut-directed hypnotherapy deals with somatic awareness and the use of imagery and suggestion to reduce pain sensations. Mindfulness-based stress reduction has been shown to be effective in inflammatory bowel disease and musculoskeletal pain syndromes. The provider should be familiar with these available methods, but should leave choice of interventions to partner mental health providers.

It’s important to distinguish between gastrointestinal pain with visceral causes and centrally mediated pain. Central sensitization can cause intermittent pain to become persistent even in the absence of ongoing peripheral causes of pain.

Peripheral acting agents affect gastrointestinal pain, and a network meta-analysis identified the top three drugs for pain relief in irritable bowel syndrome as tricyclic antidepressants, antispasmodics, and peppermint oil.

Neuromodulator drugs are an option for DGBI pain because the gut nervous system shares embryonic developmental pathways with the brain and spinal cord, which helps explains some of the benefits of low-dose antidepressants, now termed gut-brain neuromodulators. These drugs should be started at a low dose and gradually titrated according to symptom response and tolerability.

The authors have financial relationships with various pharmaceutical companies.

An American Gastroenterological Association clinical practice update for gastrointestinal pain in disorders of gut-brain interaction (DGBI), published in Clinical Gastroenterology and Hepatology, emphasizes patient-physician collaboration and improvement of patient understanding of the pathways and mechanisms of pain sensations. It is aimed at management of patients in whom pain persists after first-line therapies fail to resolve visceral causes of pain.

DGBIs include irritable bowel syndrome, functional dyspepsia, and centrally mediated abdominal pain syndrome, according to Laurie Keefer, PhD, AGAF, of the division of gastroenterology at Icahn School of Medicine at Mount Sinai, New York, and colleagues. Initial treatment usually focuses on visceral triggers of pain such as food and bowel movements, but this approach is ineffective for many.

Cognitive, affective, and behavioral factors can impact the treatment of these patients, making it a complex clinical problem that calls for a collaborative approach between the patient and clinician. Opioids and other drugs that could be misused should be avoided, according to the authors. Both pharmacologic and nonpharmacologic approaches can be considered, but the update did not address use of marijuana or other complementary or alternative therapies.

Effective management requires empathy and collaboration. The patient has often seen various other clinicians with suboptimal results, which has left them dissatisfied with their care. Cultural sensitivity is crucial because the understanding and interpretation of pain, and preferred management approaches, vary across cultures.

The first step is a nonjudgmental patient history using open-ended questions. Examples include: “How do your symptoms interfere with your ability to do what you want in your daily life?” or “How are these symptoms impacting your life the most?” These types of questions may identify patients who could benefit from behavioral health interventions.

Questions about symptom-related anxiety can improve understanding of patient concerns and offer an opportunity to address fears. Additional understanding of the patient’s perspective can come from questions like: “What do you think is causing your symptoms,” “Why are you coming to see me now?” and “What are you most concerned about with your symptoms?”

The initial assessment should ideally result in shared goals and expectations for pain management.

Providers should educate the patient about the pathogenesis of pain and how it can be modified. Pain signals can result from innocuous signals from the gut that are misinterpreted by the vigilant brain as it scans for injury or illness. That model might explain why some patients with similar diagnoses have widely differing pain experiences, and offers hope that a change in how one approaches pain might lead to improvements. Patients should be encouraged to avoid too much focus on the cause or a solution to pain, because it can interfere with acceptance of pain or, when needed, treatment.

Opioids should not be prescribed for these patients, and if they are already taking them on referral, it’s important to manage them within a multidisciplinary framework until the opioids can be discontinued. Long-term use of opioids can lead to narcotic bowel syndrome, which results in chronic and often heightened abdominal pain even with escalating opioid doses. Opioid stoppage often must be accompanied by behavioral and psychiatric therapies to ensure success.

Nonpharmacological therapies such as brain-gut psychotherapies should be brought up as potential options early in treatment, even though many patients won’t require this type of care. Early mention is likely to keep the patient more open to trying them because they’re less likely to think of it as a sign of failure or a “last-ditch” approach. Cognitive-behavioral therapy works to improve pain management skills and bolster skill deficits, with attention to pain catastrophizing, pain hypervigilance, and visceral anxiety through different techniques.

Gut-directed hypnotherapy deals with somatic awareness and the use of imagery and suggestion to reduce pain sensations. Mindfulness-based stress reduction has been shown to be effective in inflammatory bowel disease and musculoskeletal pain syndromes. The provider should be familiar with these available methods, but should leave choice of interventions to partner mental health providers.

It’s important to distinguish between gastrointestinal pain with visceral causes and centrally mediated pain. Central sensitization can cause intermittent pain to become persistent even in the absence of ongoing peripheral causes of pain.

Peripheral acting agents affect gastrointestinal pain, and a network meta-analysis identified the top three drugs for pain relief in irritable bowel syndrome as tricyclic antidepressants, antispasmodics, and peppermint oil.

Neuromodulator drugs are an option for DGBI pain because the gut nervous system shares embryonic developmental pathways with the brain and spinal cord, which helps explains some of the benefits of low-dose antidepressants, now termed gut-brain neuromodulators. These drugs should be started at a low dose and gradually titrated according to symptom response and tolerability.

The authors have financial relationships with various pharmaceutical companies.

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AHA dietary guidance cites structural challenges to heart-healthy patterns

Article Type
Changed
Tue, 05/03/2022 - 15:03

In a new scientific statement on diet and lifestyle recommendations, the American Heart Association is highlighting, for the first time, structural challenges that impede the adoption of heart-healthy dietary patterns.

American Heart Association

This is in addition to stressing aspects of diet that improve cardiovascular health and reduce cardiovascular risk, with an emphasis on dietary patterns and food-based guidance beyond naming individual foods or nutrients.

The 2021 Dietary Guidance to Improve Cardiovascular Health scientific statement, developed under Alice H. Lichtenstein, DSc, chair of the AHA writing group, provides 10 evidence-based guidance recommendations to promote cardiometabolic health.

“The way to make heart-healthy choices every day,” said Dr. Lichtenstein, of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University in Boston, in a statement, “is to step back, look at the environment in which you eat, whether it be at home, at work, during social interaction, and then identify what the best choices are. And if there are no good choices, then think about how you can modify your environment so that there are good choices.”

The statement, published in Circulation, underscores growing evidence that nutrition-related chronic diseases have maternal-nutritional origins, and that prevention of pediatric obesity is a key to preserving and prolonging ideal cardiovascular health.

The features are as follows:

  • Adjust energy intake and expenditure to achieve and maintain a healthy body weight. To counter the shift toward higher energy intake and more sedentary lifestyles over the past 3 decades, the statement recommends at least 150 minutes of moderate physical activity per week, adjusted for individual’s age, activity level, sex, and size.
  • Eat plenty of fruits and vegetables; choose a wide variety. Observational and intervention studies document that dietary patterns rich in varied fruits and vegetables, with the exception of white potatoes, are linked to a lower risk of cardiovascular disease (CVD). Also, whole fruits and vegetables, which more readily provide fiber and satiety, are preferred over juices.
  • Choose whole grain foods and products made mostly with whole grains rather than refined grains. Evidence from observational, interventional, and clinical studies confirm the benefits of frequent consumption of whole grains over infrequent consumption or over refined grains in terms of CVD risk, coronary heart disease (CHD), stroke, metabolic syndrome, cardiometabolic risk factors, laxation, and gut microbiota.
  • Choose healthy sources of protein, mostly from plants (legumes and nuts).
  • Higher intake of legumes, which are rich in protein and fiber, is associated with lower CVD risk, while higher nut intake is associated with lower risks of CVD, CHD, and stroke mortality/incidence. Replacing animal-source foods with plant-source whole foods, beyond health benefits, lowers the diet’s carbon footprint. Meat alternatives are often ultraprocessed and evidence on their short- and long-term health effects is limited. Unsaturated fats are preferred, as are lean, nonprocessed meats.
  • Use liquid plant oils rather than tropical oils (coconut, palm, and palm kernel), animal fats (butter and lard), and partially hydrogenated fats. Saturated and trans fats (animal and dairy fats, and partially hydrogenated fat) should be replaced with nontropical liquid plant oils. Evidence supports cardiovascular benefits of dietary unsaturated fats, especially polyunsaturated fats primarily from plant oils (e.g. soybean, corn, safflower and sunflower oils, walnuts, and flax seeds).
  • Choose minimally processed foods instead of ultraprocessed foods. Because of their proven association with adverse health outcomes, including overweight and obesity, cardiometabolic disorders (type 2 diabetes, CVD), and all-cause mortality, the consumption of many ultraprocessed foods is of concern. Ultraprocessed foods include artificial colors and flavors and preservatives that promote shelf stability, preserve texture, and increase palatability. A general principle is to emphasize unprocessed or minimally processed foods.
  • Minimize intake of beverages and foods with added sugars. Added sugars (commonly glucose, dextrose, sucrose, corn syrup, honey, maple syrup, and concentrated fruit juice) are tied to elevated risk for type 2 diabetes, high cholesterol, and excess body weight. Findings from meta-analyses on body weight and metabolic outcomes for replacing added sugars with low-energy sweeteners are mixed, and the possibility of reverse causality has been raised.
  • Choose and prepare foods with little or no salt. In general, the effects of sodium reduction on blood pressure tend to be higher in Black people, middle-aged and older people, and those with hypertension. In the United States, the main combined sources of sodium intake are processed foods, those prepared outside the home, packaged foods, and restaurant foods. Potassium-enriched salts are a promising alternative.
  • If you don’t drink alcohol, don’t start; if you choose to drink, limit intake.
  • While relationships between alcohol intake and cardiovascular outcomes are complex, the 2020 Dietary Guidelines Advisory Committee recently concluded that those who do drink should consume no more than one drink per day and should not drink alcohol in binges; the 2020 Dietary Guidelines for Americans con­tinues to recommend no more than one drink per day for women and two drinks per day for men.
  • Adhere to the guidance regardless in all settings. Food-based dietary guidance applies to all foods and beverages, regardless of where prepared, procured, and consumed. Policies should be enacted that encourage healthier default options (for example, whole grains, minimized sodium and sugar content).
 

 

Recognizing impediments

The AHA/ASA scientific statement closes with the declaration: “Creating an environment that facilitates, rather than impedes, adherence to heart-healthy dietary patterns among all individuals is a public health imperative.” It points to the National Institutes of Health’s 2020-2030 Strategic Plan for National Institutes of Health Nutrition Research, which focuses on precision nutrition as a means “to determine the impact on health of not only what individuals eat, but also of why, when, and how they eat throughout the life course.”

Dr. Alice H. Lichtenstein

Ultimately, precision nutrition may provide personalized diets for CVD prevention. But the “food environment,” often conditioned by “rampant nutrition misinformation” through local, state, and federal practices and policies, may impede the adoption of heart-healthy dietary patterns. Factors such as targeted food marketing (for example, of processed food and beverages in minority neighborhoods), structural racism, neighborhood segregation, unhealthy built environments, and food insecurity create environments in which unhealthy foods are the default option.”

These factors compound adverse dietary and health effects, and underscore a need to “directly combat nutrition misinformation among the public and health care professionals.” They also explain why, despite widespread knowledge of heart-healthy dietary pattern components, little progress has been made in achieving dietary goals in the United States.

Dr. Lichtenstein’s office, in response to a request regarding AHA advocacy and consumer programs, provided the following links: Voices for Healthy Kids initiative site and choosing healthier processed foods and one on fresh, frozen, and canned fruits and vegetables.

Dr. Lichtenstein had no disclosures. Disclosures for the writing group members are included in the statement.

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In a new scientific statement on diet and lifestyle recommendations, the American Heart Association is highlighting, for the first time, structural challenges that impede the adoption of heart-healthy dietary patterns.

American Heart Association

This is in addition to stressing aspects of diet that improve cardiovascular health and reduce cardiovascular risk, with an emphasis on dietary patterns and food-based guidance beyond naming individual foods or nutrients.

The 2021 Dietary Guidance to Improve Cardiovascular Health scientific statement, developed under Alice H. Lichtenstein, DSc, chair of the AHA writing group, provides 10 evidence-based guidance recommendations to promote cardiometabolic health.

“The way to make heart-healthy choices every day,” said Dr. Lichtenstein, of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University in Boston, in a statement, “is to step back, look at the environment in which you eat, whether it be at home, at work, during social interaction, and then identify what the best choices are. And if there are no good choices, then think about how you can modify your environment so that there are good choices.”

The statement, published in Circulation, underscores growing evidence that nutrition-related chronic diseases have maternal-nutritional origins, and that prevention of pediatric obesity is a key to preserving and prolonging ideal cardiovascular health.

The features are as follows:

  • Adjust energy intake and expenditure to achieve and maintain a healthy body weight. To counter the shift toward higher energy intake and more sedentary lifestyles over the past 3 decades, the statement recommends at least 150 minutes of moderate physical activity per week, adjusted for individual’s age, activity level, sex, and size.
  • Eat plenty of fruits and vegetables; choose a wide variety. Observational and intervention studies document that dietary patterns rich in varied fruits and vegetables, with the exception of white potatoes, are linked to a lower risk of cardiovascular disease (CVD). Also, whole fruits and vegetables, which more readily provide fiber and satiety, are preferred over juices.
  • Choose whole grain foods and products made mostly with whole grains rather than refined grains. Evidence from observational, interventional, and clinical studies confirm the benefits of frequent consumption of whole grains over infrequent consumption or over refined grains in terms of CVD risk, coronary heart disease (CHD), stroke, metabolic syndrome, cardiometabolic risk factors, laxation, and gut microbiota.
  • Choose healthy sources of protein, mostly from plants (legumes and nuts).
  • Higher intake of legumes, which are rich in protein and fiber, is associated with lower CVD risk, while higher nut intake is associated with lower risks of CVD, CHD, and stroke mortality/incidence. Replacing animal-source foods with plant-source whole foods, beyond health benefits, lowers the diet’s carbon footprint. Meat alternatives are often ultraprocessed and evidence on their short- and long-term health effects is limited. Unsaturated fats are preferred, as are lean, nonprocessed meats.
  • Use liquid plant oils rather than tropical oils (coconut, palm, and palm kernel), animal fats (butter and lard), and partially hydrogenated fats. Saturated and trans fats (animal and dairy fats, and partially hydrogenated fat) should be replaced with nontropical liquid plant oils. Evidence supports cardiovascular benefits of dietary unsaturated fats, especially polyunsaturated fats primarily from plant oils (e.g. soybean, corn, safflower and sunflower oils, walnuts, and flax seeds).
  • Choose minimally processed foods instead of ultraprocessed foods. Because of their proven association with adverse health outcomes, including overweight and obesity, cardiometabolic disorders (type 2 diabetes, CVD), and all-cause mortality, the consumption of many ultraprocessed foods is of concern. Ultraprocessed foods include artificial colors and flavors and preservatives that promote shelf stability, preserve texture, and increase palatability. A general principle is to emphasize unprocessed or minimally processed foods.
  • Minimize intake of beverages and foods with added sugars. Added sugars (commonly glucose, dextrose, sucrose, corn syrup, honey, maple syrup, and concentrated fruit juice) are tied to elevated risk for type 2 diabetes, high cholesterol, and excess body weight. Findings from meta-analyses on body weight and metabolic outcomes for replacing added sugars with low-energy sweeteners are mixed, and the possibility of reverse causality has been raised.
  • Choose and prepare foods with little or no salt. In general, the effects of sodium reduction on blood pressure tend to be higher in Black people, middle-aged and older people, and those with hypertension. In the United States, the main combined sources of sodium intake are processed foods, those prepared outside the home, packaged foods, and restaurant foods. Potassium-enriched salts are a promising alternative.
  • If you don’t drink alcohol, don’t start; if you choose to drink, limit intake.
  • While relationships between alcohol intake and cardiovascular outcomes are complex, the 2020 Dietary Guidelines Advisory Committee recently concluded that those who do drink should consume no more than one drink per day and should not drink alcohol in binges; the 2020 Dietary Guidelines for Americans con­tinues to recommend no more than one drink per day for women and two drinks per day for men.
  • Adhere to the guidance regardless in all settings. Food-based dietary guidance applies to all foods and beverages, regardless of where prepared, procured, and consumed. Policies should be enacted that encourage healthier default options (for example, whole grains, minimized sodium and sugar content).
 

 

Recognizing impediments

The AHA/ASA scientific statement closes with the declaration: “Creating an environment that facilitates, rather than impedes, adherence to heart-healthy dietary patterns among all individuals is a public health imperative.” It points to the National Institutes of Health’s 2020-2030 Strategic Plan for National Institutes of Health Nutrition Research, which focuses on precision nutrition as a means “to determine the impact on health of not only what individuals eat, but also of why, when, and how they eat throughout the life course.”

Dr. Alice H. Lichtenstein

Ultimately, precision nutrition may provide personalized diets for CVD prevention. But the “food environment,” often conditioned by “rampant nutrition misinformation” through local, state, and federal practices and policies, may impede the adoption of heart-healthy dietary patterns. Factors such as targeted food marketing (for example, of processed food and beverages in minority neighborhoods), structural racism, neighborhood segregation, unhealthy built environments, and food insecurity create environments in which unhealthy foods are the default option.”

These factors compound adverse dietary and health effects, and underscore a need to “directly combat nutrition misinformation among the public and health care professionals.” They also explain why, despite widespread knowledge of heart-healthy dietary pattern components, little progress has been made in achieving dietary goals in the United States.

Dr. Lichtenstein’s office, in response to a request regarding AHA advocacy and consumer programs, provided the following links: Voices for Healthy Kids initiative site and choosing healthier processed foods and one on fresh, frozen, and canned fruits and vegetables.

Dr. Lichtenstein had no disclosures. Disclosures for the writing group members are included in the statement.

In a new scientific statement on diet and lifestyle recommendations, the American Heart Association is highlighting, for the first time, structural challenges that impede the adoption of heart-healthy dietary patterns.

American Heart Association

This is in addition to stressing aspects of diet that improve cardiovascular health and reduce cardiovascular risk, with an emphasis on dietary patterns and food-based guidance beyond naming individual foods or nutrients.

The 2021 Dietary Guidance to Improve Cardiovascular Health scientific statement, developed under Alice H. Lichtenstein, DSc, chair of the AHA writing group, provides 10 evidence-based guidance recommendations to promote cardiometabolic health.

“The way to make heart-healthy choices every day,” said Dr. Lichtenstein, of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University in Boston, in a statement, “is to step back, look at the environment in which you eat, whether it be at home, at work, during social interaction, and then identify what the best choices are. And if there are no good choices, then think about how you can modify your environment so that there are good choices.”

The statement, published in Circulation, underscores growing evidence that nutrition-related chronic diseases have maternal-nutritional origins, and that prevention of pediatric obesity is a key to preserving and prolonging ideal cardiovascular health.

The features are as follows:

  • Adjust energy intake and expenditure to achieve and maintain a healthy body weight. To counter the shift toward higher energy intake and more sedentary lifestyles over the past 3 decades, the statement recommends at least 150 minutes of moderate physical activity per week, adjusted for individual’s age, activity level, sex, and size.
  • Eat plenty of fruits and vegetables; choose a wide variety. Observational and intervention studies document that dietary patterns rich in varied fruits and vegetables, with the exception of white potatoes, are linked to a lower risk of cardiovascular disease (CVD). Also, whole fruits and vegetables, which more readily provide fiber and satiety, are preferred over juices.
  • Choose whole grain foods and products made mostly with whole grains rather than refined grains. Evidence from observational, interventional, and clinical studies confirm the benefits of frequent consumption of whole grains over infrequent consumption or over refined grains in terms of CVD risk, coronary heart disease (CHD), stroke, metabolic syndrome, cardiometabolic risk factors, laxation, and gut microbiota.
  • Choose healthy sources of protein, mostly from plants (legumes and nuts).
  • Higher intake of legumes, which are rich in protein and fiber, is associated with lower CVD risk, while higher nut intake is associated with lower risks of CVD, CHD, and stroke mortality/incidence. Replacing animal-source foods with plant-source whole foods, beyond health benefits, lowers the diet’s carbon footprint. Meat alternatives are often ultraprocessed and evidence on their short- and long-term health effects is limited. Unsaturated fats are preferred, as are lean, nonprocessed meats.
  • Use liquid plant oils rather than tropical oils (coconut, palm, and palm kernel), animal fats (butter and lard), and partially hydrogenated fats. Saturated and trans fats (animal and dairy fats, and partially hydrogenated fat) should be replaced with nontropical liquid plant oils. Evidence supports cardiovascular benefits of dietary unsaturated fats, especially polyunsaturated fats primarily from plant oils (e.g. soybean, corn, safflower and sunflower oils, walnuts, and flax seeds).
  • Choose minimally processed foods instead of ultraprocessed foods. Because of their proven association with adverse health outcomes, including overweight and obesity, cardiometabolic disorders (type 2 diabetes, CVD), and all-cause mortality, the consumption of many ultraprocessed foods is of concern. Ultraprocessed foods include artificial colors and flavors and preservatives that promote shelf stability, preserve texture, and increase palatability. A general principle is to emphasize unprocessed or minimally processed foods.
  • Minimize intake of beverages and foods with added sugars. Added sugars (commonly glucose, dextrose, sucrose, corn syrup, honey, maple syrup, and concentrated fruit juice) are tied to elevated risk for type 2 diabetes, high cholesterol, and excess body weight. Findings from meta-analyses on body weight and metabolic outcomes for replacing added sugars with low-energy sweeteners are mixed, and the possibility of reverse causality has been raised.
  • Choose and prepare foods with little or no salt. In general, the effects of sodium reduction on blood pressure tend to be higher in Black people, middle-aged and older people, and those with hypertension. In the United States, the main combined sources of sodium intake are processed foods, those prepared outside the home, packaged foods, and restaurant foods. Potassium-enriched salts are a promising alternative.
  • If you don’t drink alcohol, don’t start; if you choose to drink, limit intake.
  • While relationships between alcohol intake and cardiovascular outcomes are complex, the 2020 Dietary Guidelines Advisory Committee recently concluded that those who do drink should consume no more than one drink per day and should not drink alcohol in binges; the 2020 Dietary Guidelines for Americans con­tinues to recommend no more than one drink per day for women and two drinks per day for men.
  • Adhere to the guidance regardless in all settings. Food-based dietary guidance applies to all foods and beverages, regardless of where prepared, procured, and consumed. Policies should be enacted that encourage healthier default options (for example, whole grains, minimized sodium and sugar content).
 

 

Recognizing impediments

The AHA/ASA scientific statement closes with the declaration: “Creating an environment that facilitates, rather than impedes, adherence to heart-healthy dietary patterns among all individuals is a public health imperative.” It points to the National Institutes of Health’s 2020-2030 Strategic Plan for National Institutes of Health Nutrition Research, which focuses on precision nutrition as a means “to determine the impact on health of not only what individuals eat, but also of why, when, and how they eat throughout the life course.”

Dr. Alice H. Lichtenstein

Ultimately, precision nutrition may provide personalized diets for CVD prevention. But the “food environment,” often conditioned by “rampant nutrition misinformation” through local, state, and federal practices and policies, may impede the adoption of heart-healthy dietary patterns. Factors such as targeted food marketing (for example, of processed food and beverages in minority neighborhoods), structural racism, neighborhood segregation, unhealthy built environments, and food insecurity create environments in which unhealthy foods are the default option.”

These factors compound adverse dietary and health effects, and underscore a need to “directly combat nutrition misinformation among the public and health care professionals.” They also explain why, despite widespread knowledge of heart-healthy dietary pattern components, little progress has been made in achieving dietary goals in the United States.

Dr. Lichtenstein’s office, in response to a request regarding AHA advocacy and consumer programs, provided the following links: Voices for Healthy Kids initiative site and choosing healthier processed foods and one on fresh, frozen, and canned fruits and vegetables.

Dr. Lichtenstein had no disclosures. Disclosures for the writing group members are included in the statement.

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AGA Clinical Practice Guideline: Coagulation in cirrhosis

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Mon, 11/08/2021 - 11:54

A clinical update from the American Gastroenterological Association focuses on bleeding and thrombosis-related questions in patients with cirrhosis. It provides guidance on test strategies for bleeding risk, preprocedure management of bleeding risk, venous thromboembolism (VTE) prophylaxis, screening for portal vein thrombosis (PVT), and anticoagulation therapies. It is aimed at primary care providers, gastroenterologists, and hepatologists, among other health care providers.

In cirrhosis, there are often changes to platelet (PLT) counts and prothrombin time/international normalized ratio (PT/INR), among other parameters, and historically these changes led to concerns that patients were at greater risk of bleeding or thrombosis. More recent evidence has led to a nuanced view. Neither factor necessarily suggests increased bleeding risk, and the severity of coagulopathy predicted by them does not predict the risk of bleeding complications.

Patients with cirrhosis are at greater risk of thrombosis, but clinicians may be hesitant to prescribe anticoagulants because of uncertain risk profiles, and test strategies employing PT/INR to estimate bleeding risk and track treatment endpoints in patients receiving vitamin K antagonists may not work in cirrhosis patients with alterations in procoagulant and anticoagulant measures. Recent efforts to address this led to testing of fibrin clot formation and lysis to better gauge the variety of abnormalities in cirrhosis patients.

The guideline, published in Gastroenterology, was informed by a technical review that focused on both bleeding-related and thrombosis-related questions. Bleeding-related questions included testing strategies and preprocedure prophylaxis to reduce bleeding risk. Thrombosis-related questions included whether VTE prophylaxis may be useful in hospitalized patients with cirrhosis, whether patients should be screened for PVT, potential therapies for nontumoral PVT, and whether or not anticoagulation is safe and effective when atrial fibrillation is present alongside cirrhosis.

Because of a lack of evidence, the guideline provides no recommendations on visco-elastic testing for bleeding risk in advance of common gastrointestinal procedures for patients with stable cirrhosis. It recommends against use of extensive preprocedural testing, such as repeated PT/INR or PLT count testing.

The guideline also looked at whether preprocedural efforts to correct coagulation parameters could reduce bleeding risk in patients with cirrhosis. It recommends against giving blood products ahead of the procedure for patients with stable cirrhosis without severe thrombocytopenia or severe coagulopathy. Such interventions can be considered for patients in the latter categories who are undergoing procedures with high bleeding risk after consideration of risks and benefits, and consultation with a hematologist.

Thrombopoietin receptor agonists (TPO-RAs) are also not recommended in patients with thrombocytopenia and stable cirrhosis undergoing common procedures, but they can be considered for patients who are more concerned about reduction of bleeding events and less concerned about the risk of PVT.

Patients who are hospitalized and meet the requirements should receive VTE prophylaxis. Although there is little available evidence about the effects of thromboprophylaxis in patients with cirrhosis, there is strong evidence of benefit in acutely ill hospitalized patients, and patients with cirrhosis are believed to be at a similar risk of VTE. There is evidence of increased bleed risk, but this is of very low certainty.

PVT should not be routinely tested for, but such testing can be offered to patients with a high level of concern over PVT and are not as worried about potential harms of treatment. This recommendation does not apply to patients waiting for a liver transplant.

Patients with non-umoral PVT should receive anticoagulation therapy, but patients who have high levels of concern about bleeding risk from anticoagulation and put a lower value on possible benefits of anticoagulation may choose not to receive it.

The guideline recommends anticoagulation for patients with atrial fibrillation and cirrhosis who are indicated for it. Patients with more concern about the bleeding risk of anticoagulation and place lower value on the reduction in stroke risk may choose to not receive anticoagulation. This is particularly true for those with more advanced cirrhosis (Child-Turcotte-Pugh Class C) and/or low CHA2DS2-VASC scores.

Nearly all of the recommendations in the guideline are conditional, reflecting a lack of data and a range of knowledge gaps that need filling. The authors call for additional research to identify specific patients who are at high risk for bleeding or thrombosis “to appropriately provide prophylaxis using blood product transfusion or TPO-RAs in patients at risk for clinically significant bleeding, to screen for and treat PVT, and to prevent clinically significant thromboembolic events.”

The development of the guideline was funded fully by the AGA. Members of the panel submitted conflict of interest information, and these statements are maintained at AGA headquarters.

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A clinical update from the American Gastroenterological Association focuses on bleeding and thrombosis-related questions in patients with cirrhosis. It provides guidance on test strategies for bleeding risk, preprocedure management of bleeding risk, venous thromboembolism (VTE) prophylaxis, screening for portal vein thrombosis (PVT), and anticoagulation therapies. It is aimed at primary care providers, gastroenterologists, and hepatologists, among other health care providers.

In cirrhosis, there are often changes to platelet (PLT) counts and prothrombin time/international normalized ratio (PT/INR), among other parameters, and historically these changes led to concerns that patients were at greater risk of bleeding or thrombosis. More recent evidence has led to a nuanced view. Neither factor necessarily suggests increased bleeding risk, and the severity of coagulopathy predicted by them does not predict the risk of bleeding complications.

Patients with cirrhosis are at greater risk of thrombosis, but clinicians may be hesitant to prescribe anticoagulants because of uncertain risk profiles, and test strategies employing PT/INR to estimate bleeding risk and track treatment endpoints in patients receiving vitamin K antagonists may not work in cirrhosis patients with alterations in procoagulant and anticoagulant measures. Recent efforts to address this led to testing of fibrin clot formation and lysis to better gauge the variety of abnormalities in cirrhosis patients.

The guideline, published in Gastroenterology, was informed by a technical review that focused on both bleeding-related and thrombosis-related questions. Bleeding-related questions included testing strategies and preprocedure prophylaxis to reduce bleeding risk. Thrombosis-related questions included whether VTE prophylaxis may be useful in hospitalized patients with cirrhosis, whether patients should be screened for PVT, potential therapies for nontumoral PVT, and whether or not anticoagulation is safe and effective when atrial fibrillation is present alongside cirrhosis.

Because of a lack of evidence, the guideline provides no recommendations on visco-elastic testing for bleeding risk in advance of common gastrointestinal procedures for patients with stable cirrhosis. It recommends against use of extensive preprocedural testing, such as repeated PT/INR or PLT count testing.

The guideline also looked at whether preprocedural efforts to correct coagulation parameters could reduce bleeding risk in patients with cirrhosis. It recommends against giving blood products ahead of the procedure for patients with stable cirrhosis without severe thrombocytopenia or severe coagulopathy. Such interventions can be considered for patients in the latter categories who are undergoing procedures with high bleeding risk after consideration of risks and benefits, and consultation with a hematologist.

Thrombopoietin receptor agonists (TPO-RAs) are also not recommended in patients with thrombocytopenia and stable cirrhosis undergoing common procedures, but they can be considered for patients who are more concerned about reduction of bleeding events and less concerned about the risk of PVT.

Patients who are hospitalized and meet the requirements should receive VTE prophylaxis. Although there is little available evidence about the effects of thromboprophylaxis in patients with cirrhosis, there is strong evidence of benefit in acutely ill hospitalized patients, and patients with cirrhosis are believed to be at a similar risk of VTE. There is evidence of increased bleed risk, but this is of very low certainty.

PVT should not be routinely tested for, but such testing can be offered to patients with a high level of concern over PVT and are not as worried about potential harms of treatment. This recommendation does not apply to patients waiting for a liver transplant.

Patients with non-umoral PVT should receive anticoagulation therapy, but patients who have high levels of concern about bleeding risk from anticoagulation and put a lower value on possible benefits of anticoagulation may choose not to receive it.

The guideline recommends anticoagulation for patients with atrial fibrillation and cirrhosis who are indicated for it. Patients with more concern about the bleeding risk of anticoagulation and place lower value on the reduction in stroke risk may choose to not receive anticoagulation. This is particularly true for those with more advanced cirrhosis (Child-Turcotte-Pugh Class C) and/or low CHA2DS2-VASC scores.

Nearly all of the recommendations in the guideline are conditional, reflecting a lack of data and a range of knowledge gaps that need filling. The authors call for additional research to identify specific patients who are at high risk for bleeding or thrombosis “to appropriately provide prophylaxis using blood product transfusion or TPO-RAs in patients at risk for clinically significant bleeding, to screen for and treat PVT, and to prevent clinically significant thromboembolic events.”

The development of the guideline was funded fully by the AGA. Members of the panel submitted conflict of interest information, and these statements are maintained at AGA headquarters.

A clinical update from the American Gastroenterological Association focuses on bleeding and thrombosis-related questions in patients with cirrhosis. It provides guidance on test strategies for bleeding risk, preprocedure management of bleeding risk, venous thromboembolism (VTE) prophylaxis, screening for portal vein thrombosis (PVT), and anticoagulation therapies. It is aimed at primary care providers, gastroenterologists, and hepatologists, among other health care providers.

In cirrhosis, there are often changes to platelet (PLT) counts and prothrombin time/international normalized ratio (PT/INR), among other parameters, and historically these changes led to concerns that patients were at greater risk of bleeding or thrombosis. More recent evidence has led to a nuanced view. Neither factor necessarily suggests increased bleeding risk, and the severity of coagulopathy predicted by them does not predict the risk of bleeding complications.

Patients with cirrhosis are at greater risk of thrombosis, but clinicians may be hesitant to prescribe anticoagulants because of uncertain risk profiles, and test strategies employing PT/INR to estimate bleeding risk and track treatment endpoints in patients receiving vitamin K antagonists may not work in cirrhosis patients with alterations in procoagulant and anticoagulant measures. Recent efforts to address this led to testing of fibrin clot formation and lysis to better gauge the variety of abnormalities in cirrhosis patients.

The guideline, published in Gastroenterology, was informed by a technical review that focused on both bleeding-related and thrombosis-related questions. Bleeding-related questions included testing strategies and preprocedure prophylaxis to reduce bleeding risk. Thrombosis-related questions included whether VTE prophylaxis may be useful in hospitalized patients with cirrhosis, whether patients should be screened for PVT, potential therapies for nontumoral PVT, and whether or not anticoagulation is safe and effective when atrial fibrillation is present alongside cirrhosis.

Because of a lack of evidence, the guideline provides no recommendations on visco-elastic testing for bleeding risk in advance of common gastrointestinal procedures for patients with stable cirrhosis. It recommends against use of extensive preprocedural testing, such as repeated PT/INR or PLT count testing.

The guideline also looked at whether preprocedural efforts to correct coagulation parameters could reduce bleeding risk in patients with cirrhosis. It recommends against giving blood products ahead of the procedure for patients with stable cirrhosis without severe thrombocytopenia or severe coagulopathy. Such interventions can be considered for patients in the latter categories who are undergoing procedures with high bleeding risk after consideration of risks and benefits, and consultation with a hematologist.

Thrombopoietin receptor agonists (TPO-RAs) are also not recommended in patients with thrombocytopenia and stable cirrhosis undergoing common procedures, but they can be considered for patients who are more concerned about reduction of bleeding events and less concerned about the risk of PVT.

Patients who are hospitalized and meet the requirements should receive VTE prophylaxis. Although there is little available evidence about the effects of thromboprophylaxis in patients with cirrhosis, there is strong evidence of benefit in acutely ill hospitalized patients, and patients with cirrhosis are believed to be at a similar risk of VTE. There is evidence of increased bleed risk, but this is of very low certainty.

PVT should not be routinely tested for, but such testing can be offered to patients with a high level of concern over PVT and are not as worried about potential harms of treatment. This recommendation does not apply to patients waiting for a liver transplant.

Patients with non-umoral PVT should receive anticoagulation therapy, but patients who have high levels of concern about bleeding risk from anticoagulation and put a lower value on possible benefits of anticoagulation may choose not to receive it.

The guideline recommends anticoagulation for patients with atrial fibrillation and cirrhosis who are indicated for it. Patients with more concern about the bleeding risk of anticoagulation and place lower value on the reduction in stroke risk may choose to not receive anticoagulation. This is particularly true for those with more advanced cirrhosis (Child-Turcotte-Pugh Class C) and/or low CHA2DS2-VASC scores.

Nearly all of the recommendations in the guideline are conditional, reflecting a lack of data and a range of knowledge gaps that need filling. The authors call for additional research to identify specific patients who are at high risk for bleeding or thrombosis “to appropriately provide prophylaxis using blood product transfusion or TPO-RAs in patients at risk for clinically significant bleeding, to screen for and treat PVT, and to prevent clinically significant thromboembolic events.”

The development of the guideline was funded fully by the AGA. Members of the panel submitted conflict of interest information, and these statements are maintained at AGA headquarters.

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