Guidelines

A new Clinical Practice Guideline from American Gastroenterological Association points to a stronger and better defined role for fecal and blood biomarkers in the management of Crohn’s disease, offering the most specific evidence-based recommendations yet for the use of fecal calprotectin (FCP) and serum C-reactive protein (CRP) in assessing disease activity.

Repeated monitoring with endoscopy allows for an objective assessment of inflammation and mucosal healing compared with symptoms alone. However, relying solely on endoscopy to guide management is an approach “limited by cost and resource utilization, invasiveness, and reduced patient acceptability,” wrote guideline authors on behalf of the AGA Clinical Guidelines Committee. The guideline was published online Nov. 17 in Gastroenterology.

“Use of biomarkers is no longer considered experimental and should be an integral part of IBD care and monitoring,” said Ashwin Ananthakrishnan, MBBS, MPH, a gastroenterologist with Massachusetts General Hospital in Boston and first author of the guideline. “We need further studies to define their optimal longitudinal use, but at a given time point, there is now abundant evidence that biomarkers provide significant incremental benefit over symptoms alone in assessing a patient’s status.”

Using evidence from randomized controlled trials and observational studies, and applying it to common clinical scenarios, there are conditional recommendations on the use of biomarkers in patients with established, diagnosed disease who were asymptomatic, symptomatic, or in surgically induced remission. Those recommendations, laid out in a detailed Clinical Decision Support Tool, include the following:

For asymptomatic patients: Check CRP and FCP every 6-12 months. Patients with normal levels, and who have endoscopically confirmed remission within the last 3 years without any subsequent change in symptoms or treatment, need not undergo endoscopy and can be followed with biomarker and clinical checks alone. If CRP or FCP are elevated (defined as CRP ≥ 5 mg/L, FCP ≥ 150 mcg/g), consider repeating biomarkers and/or performing endoscopic assessment of disease activity before adjusting treatment.

For mildly symptomatic patients: Role of biomarker testing may be limited and endoscopic or radiologic assessment may be required to assess active inflammation given the higher rate of false positive and false negative results with biomarkers in this population.

For patients with more severe symptoms: Elevated CRP or FCP can be used to guide treatment adjustment without endoscopic confirmation in certain situations. Normal levels may be false negative and should be confirmed by endoscopic assessment of disease activity.

For patients in surgically induced remission with a low likelihood of recurrence: FCP levels below 50 mcg/g can be used in lieu of routine endoscopic assessment within the first year after surgery. Higher FCP levels should prompt endoscopic assessment.

For patients in surgically induced remission with a high risk of recurrence: Do not rely on biomarkers. Perform endoscopic assessment.

All recommendations were deemed of low to moderate certainty based on results from randomized clinical trials and observational studies that utilized these biomarkers in patients with Crohn’s disease. Citing a dearth of quality evidence, the guideline authors determined they could not make recommendations on the use of a third proprietary biomarker — the endoscopic healing index (EHI).

Recent AGA Clinical Practice Guidelines on the role of biomarkers in ulcerative colitis, published in March, also support a strong role for fecal and blood biomarkers, determining when these can be used to avoid unneeded endoscopic assessments. However, in patients with Crohn’s disease, symptoms correlate less well with endoscopic activity.

As a result, “biomarker performance was acceptable only in asymptomatic individuals who had recently confirmed endoscopic remission; in those without recent endoscopic assessment, test performance was suboptimal.” In addition, the weaker correlation between symptoms and endoscopic activity in Crohn’s “reduced the utility of biomarker measurement to infer disease activity in those with mild symptoms.”

The guidelines were fully funded by the AGA Institute. The authors disclosed a number of potential conflicts of interest, including receiving research grants, as well as consulting and speaking fees, from pharmaceutical companies.

A new Clinical Practice Guideline from American Gastroenterological Association points to a stronger and better defined role for fecal and blood biomarkers in the management of Crohn’s disease, offering the most specific evidence-based recommendations yet for the use of fecal calprotectin (FCP) and serum C-reactive protein (CRP) in assessing disease activity.

Repeated monitoring with endoscopy allows for an objective assessment of inflammation and mucosal healing compared with symptoms alone. However, relying solely on endoscopy to guide management is an approach “limited by cost and resource utilization, invasiveness, and reduced patient acceptability,” wrote guideline authors on behalf of the AGA Clinical Guidelines Committee. The guideline was published online Nov. 17 in Gastroenterology.

“Use of biomarkers is no longer considered experimental and should be an integral part of IBD care and monitoring,” said Ashwin Ananthakrishnan, MBBS, MPH, a gastroenterologist with Massachusetts General Hospital in Boston and first author of the guideline. “We need further studies to define their optimal longitudinal use, but at a given time point, there is now abundant evidence that biomarkers provide significant incremental benefit over symptoms alone in assessing a patient’s status.”

Using evidence from randomized controlled trials and observational studies, and applying it to common clinical scenarios, there are conditional recommendations on the use of biomarkers in patients with established, diagnosed disease who were asymptomatic, symptomatic, or in surgically induced remission. Those recommendations, laid out in a detailed Clinical Decision Support Tool, include the following:

For asymptomatic patients: Check CRP and FCP every 6-12 months. Patients with normal levels, and who have endoscopically confirmed remission within the last 3 years without any subsequent change in symptoms or treatment, need not undergo endoscopy and can be followed with biomarker and clinical checks alone. If CRP or FCP are elevated (defined as CRP ≥ 5 mg/L, FCP ≥ 150 mcg/g), consider repeating biomarkers and/or performing endoscopic assessment of disease activity before adjusting treatment.

For mildly symptomatic patients: Role of biomarker testing may be limited and endoscopic or radiologic assessment may be required to assess active inflammation given the higher rate of false positive and false negative results with biomarkers in this population.

For patients with more severe symptoms: Elevated CRP or FCP can be used to guide treatment adjustment without endoscopic confirmation in certain situations. Normal levels may be false negative and should be confirmed by endoscopic assessment of disease activity.

For patients in surgically induced remission with a low likelihood of recurrence: FCP levels below 50 mcg/g can be used in lieu of routine endoscopic assessment within the first year after surgery. Higher FCP levels should prompt endoscopic assessment.

For patients in surgically induced remission with a high risk of recurrence: Do not rely on biomarkers. Perform endoscopic assessment.

All recommendations were deemed of low to moderate certainty based on results from randomized clinical trials and observational studies that utilized these biomarkers in patients with Crohn’s disease. Citing a dearth of quality evidence, the guideline authors determined they could not make recommendations on the use of a third proprietary biomarker — the endoscopic healing index (EHI).

Recent AGA Clinical Practice Guidelines on the role of biomarkers in ulcerative colitis, published in March, also support a strong role for fecal and blood biomarkers, determining when these can be used to avoid unneeded endoscopic assessments. However, in patients with Crohn’s disease, symptoms correlate less well with endoscopic activity.

As a result, “biomarker performance was acceptable only in asymptomatic individuals who had recently confirmed endoscopic remission; in those without recent endoscopic assessment, test performance was suboptimal.” In addition, the weaker correlation between symptoms and endoscopic activity in Crohn’s “reduced the utility of biomarker measurement to infer disease activity in those with mild symptoms.”

The guidelines were fully funded by the AGA Institute. The authors disclosed a number of potential conflicts of interest, including receiving research grants, as well as consulting and speaking fees, from pharmaceutical companies.

A new Clinical Practice Guideline from American Gastroenterological Association points to a stronger and better defined role for fecal and blood biomarkers in the management of Crohn’s disease, offering the most specific evidence-based recommendations yet for the use of fecal calprotectin (FCP) and serum C-reactive protein (CRP) in assessing disease activity.

Repeated monitoring with endoscopy allows for an objective assessment of inflammation and mucosal healing compared with symptoms alone. However, relying solely on endoscopy to guide management is an approach “limited by cost and resource utilization, invasiveness, and reduced patient acceptability,” wrote guideline authors on behalf of the AGA Clinical Guidelines Committee. The guideline was published online Nov. 17 in Gastroenterology.

“Use of biomarkers is no longer considered experimental and should be an integral part of IBD care and monitoring,” said Ashwin Ananthakrishnan, MBBS, MPH, a gastroenterologist with Massachusetts General Hospital in Boston and first author of the guideline. “We need further studies to define their optimal longitudinal use, but at a given time point, there is now abundant evidence that biomarkers provide significant incremental benefit over symptoms alone in assessing a patient’s status.”

Using evidence from randomized controlled trials and observational studies, and applying it to common clinical scenarios, there are conditional recommendations on the use of biomarkers in patients with established, diagnosed disease who were asymptomatic, symptomatic, or in surgically induced remission. Those recommendations, laid out in a detailed Clinical Decision Support Tool, include the following:

For asymptomatic patients: Check CRP and FCP every 6-12 months. Patients with normal levels, and who have endoscopically confirmed remission within the last 3 years without any subsequent change in symptoms or treatment, need not undergo endoscopy and can be followed with biomarker and clinical checks alone. If CRP or FCP are elevated (defined as CRP ≥ 5 mg/L, FCP ≥ 150 mcg/g), consider repeating biomarkers and/or performing endoscopic assessment of disease activity before adjusting treatment.

For mildly symptomatic patients: Role of biomarker testing may be limited and endoscopic or radiologic assessment may be required to assess active inflammation given the higher rate of false positive and false negative results with biomarkers in this population.

For patients with more severe symptoms: Elevated CRP or FCP can be used to guide treatment adjustment without endoscopic confirmation in certain situations. Normal levels may be false negative and should be confirmed by endoscopic assessment of disease activity.

For patients in surgically induced remission with a low likelihood of recurrence: FCP levels below 50 mcg/g can be used in lieu of routine endoscopic assessment within the first year after surgery. Higher FCP levels should prompt endoscopic assessment.

For patients in surgically induced remission with a high risk of recurrence: Do not rely on biomarkers. Perform endoscopic assessment.

All recommendations were deemed of low to moderate certainty based on results from randomized clinical trials and observational studies that utilized these biomarkers in patients with Crohn’s disease. Citing a dearth of quality evidence, the guideline authors determined they could not make recommendations on the use of a third proprietary biomarker — the endoscopic healing index (EHI).

Recent AGA Clinical Practice Guidelines on the role of biomarkers in ulcerative colitis, published in March, also support a strong role for fecal and blood biomarkers, determining when these can be used to avoid unneeded endoscopic assessments. However, in patients with Crohn’s disease, symptoms correlate less well with endoscopic activity.

As a result, “biomarker performance was acceptable only in asymptomatic individuals who had recently confirmed endoscopic remission; in those without recent endoscopic assessment, test performance was suboptimal.” In addition, the weaker correlation between symptoms and endoscopic activity in Crohn’s “reduced the utility of biomarker measurement to infer disease activity in those with mild symptoms.”

The guidelines were fully funded by the AGA Institute. The authors disclosed a number of potential conflicts of interest, including receiving research grants, as well as consulting and speaking fees, from pharmaceutical companies.

The American Society for Radiation Oncology (ASTRO) has issued an updated clinical practice guideline on partial breast irradiation for women with early-stage invasive breast cancer or ductal carcinoma in situ (DCIS). The 2023 guideline, which replaces the 2017 recommendations, factors in new clinical trial data that consistently show no significant differences in overall survival, cancer-free survival, and recurrence in the same breast among patients who receive partial breast irradiation compared with whole breast irradiation. The data also indicate similar or improved side effects with partial vs whole breast irradiation.

To develop the 2023 recommendations, the Agency for Healthcare Research and Quality (AHRQ) conducted a systematic review assessing the latest clinical trial evidence, and ASTRO assembled an expert task force to determine best practices for using partial breast irradiation.

“There have been more than 10,000 women included in these randomized controlled trials, with 10 years of follow-up showing equivalency in tumor control between partial breast and whole breast radiation for appropriately selected patients,” Simona Shaitelman, MD, vice chair of the guideline task force, said in a news release.

“These data should be driving a change in practice, and partial breast radiation should be a larger part of the dialogue when we consult with patients on decisions about how best to treat their early-stage breast cancer,” added Dr. Shaitelman, professor of breast radiation oncology at the University of Texas MD Anderson Cancer Center in Houston.

What’s in the New Guidelines?

For patients with early-stage, node-negative invasive breast cancer, the updated guideline strongly recommends partial breast irradiation instead of whole breast irradiation if the patient has favorable clinical features and tumor characteristics, including grade 1 or 2 disease, estrogen receptor (ER)-positive status, small tumor size, and age 40 or older.

In contrast, the 2017 guideline considered patients aged 50 and older suitable for partial breast irradiation and considered those in their 40s who met certain pathologic criteria “cautionary.”The updated guideline also conditionally recommends partial over whole breast irradiation if the patient has risk factors that indicate a higher likelihood of recurrence, such as grade 3 disease, ER-negative histology, or larger tumor size.

The task force does not recommend partial breast irradiation for patients with positive lymph nodes, positive surgical margins, or germline BRCA1/2 mutations or patients under 40.

Given the lack of robust data in patients with less favorable risk features, such as lymphovascular invasion or lobular histology, partial breast irradiation is conditionally not recommended for these patients.

For DCIS, the updated recommendations mirror those for early-stage breast cancer, with partial breast irradiation strongly recommended as an alternative to whole breast irradiation among patients with favorable clinical and tumor features, such as grade 1 or 2 disease and ER-positive status. Partial breast irradiation is conditionally recommended for higher grade disease or larger tumors, and not recommended for patients with positive surgical margins, BRCA mutations or those younger than 40.

In addition to relevant patient populations, the updated guidelines also address techniques and best practices for delivering partial breast irradiation.

Recommended partial breast irradiation techniques include 3-D conformal radiation therapy, intensity modulated radiation therapy, and multicatheter interstitial brachytherapy, given the evidence showing similar long-term rates of ipsilateral breast recurrence compared with whole breast irradiation.

Single-entry catheter brachytherapy is conditionally recommended, and intraoperative radiation therapy techniques are not recommended unless integrated into a prospective clinical trial or multi-institutional registry.

The guideline also outlines optimal dose, fractionation, target volume, and treatment modality with different partial breast irradiation techniques, taking toxicities and cosmesis into consideration.

“We hope that by laying out the evidence from these major trials and providing guidance on how to administer partial breast radiation, the guideline can help more oncologists feel comfortable offering this option to their patients as an alternative to whole breast radiation,” Janice Lyons, MD, of University Hospitals Seidman Cancer Center, Cleveland, Ohio, and chair of the guideline task force, said in the news release.

The guideline, developed in collaboration with the American Society of Clinical Oncology and the Society of Surgical Oncology, has been endorsed by the Canadian Association of Radiation Oncology, the European Society for Radiotherapy and Oncology, and the Royal Australian and New Zealand College of Radiologists. Guideline development was funded by ASTRO and the systematic evidence review was funded by the Patient-Centered Outcomes Research Institute. Disclosures for the task force are available with the original article.
 

A version of this article was first published on Medscape.com.

The American Society for Radiation Oncology (ASTRO) has issued an updated clinical practice guideline on partial breast irradiation for women with early-stage invasive breast cancer or ductal carcinoma in situ (DCIS). The 2023 guideline, which replaces the 2017 recommendations, factors in new clinical trial data that consistently show no significant differences in overall survival, cancer-free survival, and recurrence in the same breast among patients who receive partial breast irradiation compared with whole breast irradiation. The data also indicate similar or improved side effects with partial vs whole breast irradiation.

To develop the 2023 recommendations, the Agency for Healthcare Research and Quality (AHRQ) conducted a systematic review assessing the latest clinical trial evidence, and ASTRO assembled an expert task force to determine best practices for using partial breast irradiation.

“There have been more than 10,000 women included in these randomized controlled trials, with 10 years of follow-up showing equivalency in tumor control between partial breast and whole breast radiation for appropriately selected patients,” Simona Shaitelman, MD, vice chair of the guideline task force, said in a news release.

“These data should be driving a change in practice, and partial breast radiation should be a larger part of the dialogue when we consult with patients on decisions about how best to treat their early-stage breast cancer,” added Dr. Shaitelman, professor of breast radiation oncology at the University of Texas MD Anderson Cancer Center in Houston.

What’s in the New Guidelines?

For patients with early-stage, node-negative invasive breast cancer, the updated guideline strongly recommends partial breast irradiation instead of whole breast irradiation if the patient has favorable clinical features and tumor characteristics, including grade 1 or 2 disease, estrogen receptor (ER)-positive status, small tumor size, and age 40 or older.

In contrast, the 2017 guideline considered patients aged 50 and older suitable for partial breast irradiation and considered those in their 40s who met certain pathologic criteria “cautionary.”The updated guideline also conditionally recommends partial over whole breast irradiation if the patient has risk factors that indicate a higher likelihood of recurrence, such as grade 3 disease, ER-negative histology, or larger tumor size.

The task force does not recommend partial breast irradiation for patients with positive lymph nodes, positive surgical margins, or germline BRCA1/2 mutations or patients under 40.

Given the lack of robust data in patients with less favorable risk features, such as lymphovascular invasion or lobular histology, partial breast irradiation is conditionally not recommended for these patients.

For DCIS, the updated recommendations mirror those for early-stage breast cancer, with partial breast irradiation strongly recommended as an alternative to whole breast irradiation among patients with favorable clinical and tumor features, such as grade 1 or 2 disease and ER-positive status. Partial breast irradiation is conditionally recommended for higher grade disease or larger tumors, and not recommended for patients with positive surgical margins, BRCA mutations or those younger than 40.

In addition to relevant patient populations, the updated guidelines also address techniques and best practices for delivering partial breast irradiation.

Recommended partial breast irradiation techniques include 3-D conformal radiation therapy, intensity modulated radiation therapy, and multicatheter interstitial brachytherapy, given the evidence showing similar long-term rates of ipsilateral breast recurrence compared with whole breast irradiation.

Single-entry catheter brachytherapy is conditionally recommended, and intraoperative radiation therapy techniques are not recommended unless integrated into a prospective clinical trial or multi-institutional registry.

The guideline also outlines optimal dose, fractionation, target volume, and treatment modality with different partial breast irradiation techniques, taking toxicities and cosmesis into consideration.

“We hope that by laying out the evidence from these major trials and providing guidance on how to administer partial breast radiation, the guideline can help more oncologists feel comfortable offering this option to their patients as an alternative to whole breast radiation,” Janice Lyons, MD, of University Hospitals Seidman Cancer Center, Cleveland, Ohio, and chair of the guideline task force, said in the news release.

The guideline, developed in collaboration with the American Society of Clinical Oncology and the Society of Surgical Oncology, has been endorsed by the Canadian Association of Radiation Oncology, the European Society for Radiotherapy and Oncology, and the Royal Australian and New Zealand College of Radiologists. Guideline development was funded by ASTRO and the systematic evidence review was funded by the Patient-Centered Outcomes Research Institute. Disclosures for the task force are available with the original article.
 

A version of this article was first published on Medscape.com.

The American Society for Radiation Oncology (ASTRO) has issued an updated clinical practice guideline on partial breast irradiation for women with early-stage invasive breast cancer or ductal carcinoma in situ (DCIS). The 2023 guideline, which replaces the 2017 recommendations, factors in new clinical trial data that consistently show no significant differences in overall survival, cancer-free survival, and recurrence in the same breast among patients who receive partial breast irradiation compared with whole breast irradiation. The data also indicate similar or improved side effects with partial vs whole breast irradiation.

To develop the 2023 recommendations, the Agency for Healthcare Research and Quality (AHRQ) conducted a systematic review assessing the latest clinical trial evidence, and ASTRO assembled an expert task force to determine best practices for using partial breast irradiation.

“There have been more than 10,000 women included in these randomized controlled trials, with 10 years of follow-up showing equivalency in tumor control between partial breast and whole breast radiation for appropriately selected patients,” Simona Shaitelman, MD, vice chair of the guideline task force, said in a news release.

“These data should be driving a change in practice, and partial breast radiation should be a larger part of the dialogue when we consult with patients on decisions about how best to treat their early-stage breast cancer,” added Dr. Shaitelman, professor of breast radiation oncology at the University of Texas MD Anderson Cancer Center in Houston.

What’s in the New Guidelines?

For patients with early-stage, node-negative invasive breast cancer, the updated guideline strongly recommends partial breast irradiation instead of whole breast irradiation if the patient has favorable clinical features and tumor characteristics, including grade 1 or 2 disease, estrogen receptor (ER)-positive status, small tumor size, and age 40 or older.

In contrast, the 2017 guideline considered patients aged 50 and older suitable for partial breast irradiation and considered those in their 40s who met certain pathologic criteria “cautionary.”The updated guideline also conditionally recommends partial over whole breast irradiation if the patient has risk factors that indicate a higher likelihood of recurrence, such as grade 3 disease, ER-negative histology, or larger tumor size.

The task force does not recommend partial breast irradiation for patients with positive lymph nodes, positive surgical margins, or germline BRCA1/2 mutations or patients under 40.

Given the lack of robust data in patients with less favorable risk features, such as lymphovascular invasion or lobular histology, partial breast irradiation is conditionally not recommended for these patients.

For DCIS, the updated recommendations mirror those for early-stage breast cancer, with partial breast irradiation strongly recommended as an alternative to whole breast irradiation among patients with favorable clinical and tumor features, such as grade 1 or 2 disease and ER-positive status. Partial breast irradiation is conditionally recommended for higher grade disease or larger tumors, and not recommended for patients with positive surgical margins, BRCA mutations or those younger than 40.

In addition to relevant patient populations, the updated guidelines also address techniques and best practices for delivering partial breast irradiation.

Recommended partial breast irradiation techniques include 3-D conformal radiation therapy, intensity modulated radiation therapy, and multicatheter interstitial brachytherapy, given the evidence showing similar long-term rates of ipsilateral breast recurrence compared with whole breast irradiation.

Single-entry catheter brachytherapy is conditionally recommended, and intraoperative radiation therapy techniques are not recommended unless integrated into a prospective clinical trial or multi-institutional registry.

The guideline also outlines optimal dose, fractionation, target volume, and treatment modality with different partial breast irradiation techniques, taking toxicities and cosmesis into consideration.

“We hope that by laying out the evidence from these major trials and providing guidance on how to administer partial breast radiation, the guideline can help more oncologists feel comfortable offering this option to their patients as an alternative to whole breast radiation,” Janice Lyons, MD, of University Hospitals Seidman Cancer Center, Cleveland, Ohio, and chair of the guideline task force, said in the news release.

The guideline, developed in collaboration with the American Society of Clinical Oncology and the Society of Surgical Oncology, has been endorsed by the Canadian Association of Radiation Oncology, the European Society for Radiotherapy and Oncology, and the Royal Australian and New Zealand College of Radiologists. Guideline development was funded by ASTRO and the systematic evidence review was funded by the Patient-Centered Outcomes Research Institute. Disclosures for the task force are available with the original article.
 

A version of this article was first published on Medscape.com.

The American Heart Association (AHA) and American Academy of Pediatrics (AAP) have issued a focused update to the 2020 neonatal resuscitation guidelines.

The 2023 focused update was prompted by four systematic literature reviews by the International Liaison Committee on Resuscitation (ILCOR) Neonatal Life Support Task Force.

“Evidence evaluations by the ILCOR play a large role in the group’s process and timing of updates,” Henry Lee, MD, co-chair of the writing group, said in an interview.

He noted that updated recommendations do not change prior recommendations from the 2020 guidelines.

“However, they provide additional details to consider in neonatal resuscitation that could lead to changes in some practice in various settings,” said Dr. Lee, medical director of the University of California San Diego neonatal intensive care unit. 

The focused update was simultaneously published online November 16 in Circulation and in Pediatrics.

Dr. Lee noted that effective positive-pressure ventilation (PPV) is the priority in newborn infants who need support after birth.

And while the 2020 update provided some details on devices to be used for PPV, the 2023 focused update gives guidance on use of T-piece resuscitators for providing PPV, which may be particularly helpful for preterm infants, and the use of supraglottic airways as a primary interface to deliver PPV, he explained.

Specifically, the updated guidelines state that use of a T-piece resuscitator to deliver PPV is preferred to the use of a self-inflating bag.

Because both T-piece resuscitators and flow-inflating bags require a compressed gas source to function, a self-inflating bag should be available as a backup in the event of compressed gas failure when using either of these devices.

Use of a supraglottic airway may be considered as the primary interface to administer PPV instead of a face mask for newborn infants delivered at 34 0/7 weeks’ gestation or later.


 

Continued Emphasis on Delayed Cord Clamping

The updated guidelines “continue to emphasize delayed cord clamping for both term and preterm newborn infants when clinically possible. There is also a new recommendation for nonvigorous infants born 35-42 weeks’ gestational age to consider umbilical cord milking,” Dr. Lee said in an interview.

Specifically, the guidelines state: 

• For term and late preterm newborn infants ≥34 weeks’ gestation, and preterm newborn infants <34 weeks’ gestation, who do not require resuscitation, delayed cord clamping (≥30 seconds) can be beneficial compared with early cord clamping (<30 seconds).
• For term and late preterm newborn infants ≥34 weeks’ gestation who do not require resuscitation, intact cord milking is not known to be beneficial compared with delayed cord clamping (≥30 seconds).
• For preterm newborn infants between 28- and 34-weeks’ gestation who do not require resuscitation and in whom delayed cord clamping cannot be performed, intact cord milking may be reasonable.
• For preterm newborn infants <28 weeks’ gestation, intact cord milking is not recommended.
• For nonvigorous term and late preterm infants (35-42 weeks’ gestation), intact cord milking may be reasonable compared with early cord clamping (<30 seconds).

The guidelines also highlight the following knowledge gaps that require further research:

• Optimal management of the umbilical cord in term, late preterm, and preterm infants who require resuscitation at delivery
• Longer-term outcome data, such as anemia during infancy and neurodevelopmental outcomes, for all umbilical cord management strategies
• Cost-effectiveness of a T-piece resuscitator compared with a self-inflating bag
• The effect of a self-inflating bag with a positive end-expiratory pressure valve on outcomes in preterm newborn infants
• Comparison of either a T-piece resuscitator or a self-inflating bag with a flow-inflating bag for administering PPV
• Comparison of clinical outcomes by gestational age for any PPV device
• Comparison of supraglottic airway devices and face masks as the primary interface for PPV in high-resourced settings
• The amount and type of training required for successful supraglottic airway insertion and the potential for skill decay
• The utility of supraglottic airway devices for suctioning secretions from the airway
• The efficacy of a supraglottic airway during advanced neonatal resuscitation requiring chest compressions or the delivery of intratracheal medications

This research had no commercial funding. The authors report no relevant financial relationships.

A version of this article appeared on Medscape.com.

The American Heart Association (AHA) and American Academy of Pediatrics (AAP) have issued a focused update to the 2020 neonatal resuscitation guidelines.

The 2023 focused update was prompted by four systematic literature reviews by the International Liaison Committee on Resuscitation (ILCOR) Neonatal Life Support Task Force.

“Evidence evaluations by the ILCOR play a large role in the group’s process and timing of updates,” Henry Lee, MD, co-chair of the writing group, said in an interview.

He noted that updated recommendations do not change prior recommendations from the 2020 guidelines.

“However, they provide additional details to consider in neonatal resuscitation that could lead to changes in some practice in various settings,” said Dr. Lee, medical director of the University of California San Diego neonatal intensive care unit. 

The focused update was simultaneously published online November 16 in Circulation and in Pediatrics.

Dr. Lee noted that effective positive-pressure ventilation (PPV) is the priority in newborn infants who need support after birth.

And while the 2020 update provided some details on devices to be used for PPV, the 2023 focused update gives guidance on use of T-piece resuscitators for providing PPV, which may be particularly helpful for preterm infants, and the use of supraglottic airways as a primary interface to deliver PPV, he explained.

Specifically, the updated guidelines state that use of a T-piece resuscitator to deliver PPV is preferred to the use of a self-inflating bag.

Because both T-piece resuscitators and flow-inflating bags require a compressed gas source to function, a self-inflating bag should be available as a backup in the event of compressed gas failure when using either of these devices.

Use of a supraglottic airway may be considered as the primary interface to administer PPV instead of a face mask for newborn infants delivered at 34 0/7 weeks’ gestation or later.


 

Continued Emphasis on Delayed Cord Clamping

The updated guidelines “continue to emphasize delayed cord clamping for both term and preterm newborn infants when clinically possible. There is also a new recommendation for nonvigorous infants born 35-42 weeks’ gestational age to consider umbilical cord milking,” Dr. Lee said in an interview.

Specifically, the guidelines state: 

• For term and late preterm newborn infants ≥34 weeks’ gestation, and preterm newborn infants <34 weeks’ gestation, who do not require resuscitation, delayed cord clamping (≥30 seconds) can be beneficial compared with early cord clamping (<30 seconds).
• For term and late preterm newborn infants ≥34 weeks’ gestation who do not require resuscitation, intact cord milking is not known to be beneficial compared with delayed cord clamping (≥30 seconds).
• For preterm newborn infants between 28- and 34-weeks’ gestation who do not require resuscitation and in whom delayed cord clamping cannot be performed, intact cord milking may be reasonable.
• For preterm newborn infants <28 weeks’ gestation, intact cord milking is not recommended.
• For nonvigorous term and late preterm infants (35-42 weeks’ gestation), intact cord milking may be reasonable compared with early cord clamping (<30 seconds).

The guidelines also highlight the following knowledge gaps that require further research:

• Optimal management of the umbilical cord in term, late preterm, and preterm infants who require resuscitation at delivery
• Longer-term outcome data, such as anemia during infancy and neurodevelopmental outcomes, for all umbilical cord management strategies
• Cost-effectiveness of a T-piece resuscitator compared with a self-inflating bag
• The effect of a self-inflating bag with a positive end-expiratory pressure valve on outcomes in preterm newborn infants
• Comparison of either a T-piece resuscitator or a self-inflating bag with a flow-inflating bag for administering PPV
• Comparison of clinical outcomes by gestational age for any PPV device
• Comparison of supraglottic airway devices and face masks as the primary interface for PPV in high-resourced settings
• The amount and type of training required for successful supraglottic airway insertion and the potential for skill decay
• The utility of supraglottic airway devices for suctioning secretions from the airway
• The efficacy of a supraglottic airway during advanced neonatal resuscitation requiring chest compressions or the delivery of intratracheal medications

This research had no commercial funding. The authors report no relevant financial relationships.

A version of this article appeared on Medscape.com.

The American Heart Association (AHA) and American Academy of Pediatrics (AAP) have issued a focused update to the 2020 neonatal resuscitation guidelines.

The 2023 focused update was prompted by four systematic literature reviews by the International Liaison Committee on Resuscitation (ILCOR) Neonatal Life Support Task Force.

“Evidence evaluations by the ILCOR play a large role in the group’s process and timing of updates,” Henry Lee, MD, co-chair of the writing group, said in an interview.

He noted that updated recommendations do not change prior recommendations from the 2020 guidelines.

“However, they provide additional details to consider in neonatal resuscitation that could lead to changes in some practice in various settings,” said Dr. Lee, medical director of the University of California San Diego neonatal intensive care unit. 

The focused update was simultaneously published online November 16 in Circulation and in Pediatrics.

Dr. Lee noted that effective positive-pressure ventilation (PPV) is the priority in newborn infants who need support after birth.

And while the 2020 update provided some details on devices to be used for PPV, the 2023 focused update gives guidance on use of T-piece resuscitators for providing PPV, which may be particularly helpful for preterm infants, and the use of supraglottic airways as a primary interface to deliver PPV, he explained.

Specifically, the updated guidelines state that use of a T-piece resuscitator to deliver PPV is preferred to the use of a self-inflating bag.

Because both T-piece resuscitators and flow-inflating bags require a compressed gas source to function, a self-inflating bag should be available as a backup in the event of compressed gas failure when using either of these devices.

Use of a supraglottic airway may be considered as the primary interface to administer PPV instead of a face mask for newborn infants delivered at 34 0/7 weeks’ gestation or later.


 

Continued Emphasis on Delayed Cord Clamping

The updated guidelines “continue to emphasize delayed cord clamping for both term and preterm newborn infants when clinically possible. There is also a new recommendation for nonvigorous infants born 35-42 weeks’ gestational age to consider umbilical cord milking,” Dr. Lee said in an interview.

Specifically, the guidelines state: 

• For term and late preterm newborn infants ≥34 weeks’ gestation, and preterm newborn infants <34 weeks’ gestation, who do not require resuscitation, delayed cord clamping (≥30 seconds) can be beneficial compared with early cord clamping (<30 seconds).
• For term and late preterm newborn infants ≥34 weeks’ gestation who do not require resuscitation, intact cord milking is not known to be beneficial compared with delayed cord clamping (≥30 seconds).
• For preterm newborn infants between 28- and 34-weeks’ gestation who do not require resuscitation and in whom delayed cord clamping cannot be performed, intact cord milking may be reasonable.
• For preterm newborn infants <28 weeks’ gestation, intact cord milking is not recommended.
• For nonvigorous term and late preterm infants (35-42 weeks’ gestation), intact cord milking may be reasonable compared with early cord clamping (<30 seconds).

The guidelines also highlight the following knowledge gaps that require further research:

• Optimal management of the umbilical cord in term, late preterm, and preterm infants who require resuscitation at delivery
• Longer-term outcome data, such as anemia during infancy and neurodevelopmental outcomes, for all umbilical cord management strategies
• Cost-effectiveness of a T-piece resuscitator compared with a self-inflating bag
• The effect of a self-inflating bag with a positive end-expiratory pressure valve on outcomes in preterm newborn infants
• Comparison of either a T-piece resuscitator or a self-inflating bag with a flow-inflating bag for administering PPV
• Comparison of clinical outcomes by gestational age for any PPV device
• Comparison of supraglottic airway devices and face masks as the primary interface for PPV in high-resourced settings
• The amount and type of training required for successful supraglottic airway insertion and the potential for skill decay
• The utility of supraglottic airway devices for suctioning secretions from the airway
• The efficacy of a supraglottic airway during advanced neonatal resuscitation requiring chest compressions or the delivery of intratracheal medications

This research had no commercial funding. The authors report no relevant financial relationships.

A version of this article appeared on Medscape.com.

The American College of Cardiology (ACC), the American Heart Association (AHA), the American College of Chest Physicians (ACCP), and the Heart Rhythm Society (HRS) have issued an updated guideline for preventing and optimally managing atrial fibrillation (AF).

The 2023 ACC/AHA/ACCP/HRS Guideline for Diagnosis and Management of Atrial Fibrillation was published online in the Journal of the American College of Cardiology and Circulation.

“The new guideline has important changes,” including a new way to classify AF, Jose Joglar, MD, professor of cardiac electrophysiology at UT Southwestern Medical Center in Dallas, Texas, and chair of the writing committee, said in an interview.

The previous classification was largely based only on arrhythmia duration and tended to emphasize specific therapeutic interventions rather than a more holistic and multidisciplinary management approach, Dr. Joglar explained.

The new proposed classification, using four stages, recognizes AF as a disease continuum that requires a variety of strategies at different stages, from prevention, lifestyle and risk factor modification, screening, and therapy.

Stage 1: At risk for AF due to the presence of risk factors

Stage 2: Pre-AF, with evidence of structural or electrical findings predisposing to AF

Stage 3: AF, including paroxysmal (3A), persistent (3B), long-standing persistent (3C), successful AF ablation (3D)

Stage 4: Permanent AF

The updated guideline recognizes lifestyle and risk factor modification as a “pillar” of AF management and offers “more prescriptive” recommendations, including management of obesity, weight loss, physical activity, smoking cessation, alcohol moderation, hypertension, and other comorbidities.

“We should not only be telling patients they need to be healthy, which doesn’t mean much to a patient, we need to tell them precisely what they need to do. For example, how much exercise to do or how much weight to lose to have a benefit,” Dr. Joglar said in an interview.

The good news for many people, he noted, is that coffee, which has had a “bad reputation,” is okay, as the latest data show it doesn’t seem to exacerbate AF.

The new guideline continues to endorse use of the CHA2DS2-VASc score as the predictor of choice to determine the risk of stroke, but it also allows for flexibility to use other calculators when uncertainty exists or when other risk factors, such as kidney disease, need to be included.

With the emergence of “new and consistent” evidence, the guideline also emphasizes the importance of early and continued management of patients with AF with a focus on maintaining sinus rhythm and minimizing AF burden.

Catheter ablation of AF is given a class 1 indication as first-line therapy in selected patients, including those with heart failure with reduced ejection fraction.

That’s based on recent randomized studies that have shown catheter ablation to be “superior to pharmacological therapy” for rhythm control in appropriately selected patients, Dr. Joglar told this news organization.

“There’s no need to try pharmacological therapies after a discussion between the patient and doctor and they decide that they want to proceed with the most effective intervention,” he added.

The new guideline also upgrades the class of recommendation for left atrial appendage occlusion devices to 2a, compared with the 2019 AF Focused Update, for use of these devices in patients with long-term contraindications to anticoagulation.

It also provides updated recommendations for AF detected via implantable devices and wearables as well as recommendations for patients with AF identified during medical illness or surgery.

Development of the guideline had no commercial funding. Disclosures for the writing group are available with the original articles.

A version of this article appeared on Medscape.com.

The American College of Cardiology (ACC), the American Heart Association (AHA), the American College of Chest Physicians (ACCP), and the Heart Rhythm Society (HRS) have issued an updated guideline for preventing and optimally managing atrial fibrillation (AF).

The 2023 ACC/AHA/ACCP/HRS Guideline for Diagnosis and Management of Atrial Fibrillation was published online in the Journal of the American College of Cardiology and Circulation.

“The new guideline has important changes,” including a new way to classify AF, Jose Joglar, MD, professor of cardiac electrophysiology at UT Southwestern Medical Center in Dallas, Texas, and chair of the writing committee, said in an interview.

The previous classification was largely based only on arrhythmia duration and tended to emphasize specific therapeutic interventions rather than a more holistic and multidisciplinary management approach, Dr. Joglar explained.

The new proposed classification, using four stages, recognizes AF as a disease continuum that requires a variety of strategies at different stages, from prevention, lifestyle and risk factor modification, screening, and therapy.

Stage 1: At risk for AF due to the presence of risk factors

Stage 2: Pre-AF, with evidence of structural or electrical findings predisposing to AF

Stage 3: AF, including paroxysmal (3A), persistent (3B), long-standing persistent (3C), successful AF ablation (3D)

Stage 4: Permanent AF

The updated guideline recognizes lifestyle and risk factor modification as a “pillar” of AF management and offers “more prescriptive” recommendations, including management of obesity, weight loss, physical activity, smoking cessation, alcohol moderation, hypertension, and other comorbidities.

“We should not only be telling patients they need to be healthy, which doesn’t mean much to a patient, we need to tell them precisely what they need to do. For example, how much exercise to do or how much weight to lose to have a benefit,” Dr. Joglar said in an interview.

The good news for many people, he noted, is that coffee, which has had a “bad reputation,” is okay, as the latest data show it doesn’t seem to exacerbate AF.

The new guideline continues to endorse use of the CHA2DS2-VASc score as the predictor of choice to determine the risk of stroke, but it also allows for flexibility to use other calculators when uncertainty exists or when other risk factors, such as kidney disease, need to be included.

With the emergence of “new and consistent” evidence, the guideline also emphasizes the importance of early and continued management of patients with AF with a focus on maintaining sinus rhythm and minimizing AF burden.

Catheter ablation of AF is given a class 1 indication as first-line therapy in selected patients, including those with heart failure with reduced ejection fraction.

That’s based on recent randomized studies that have shown catheter ablation to be “superior to pharmacological therapy” for rhythm control in appropriately selected patients, Dr. Joglar told this news organization.

“There’s no need to try pharmacological therapies after a discussion between the patient and doctor and they decide that they want to proceed with the most effective intervention,” he added.

The new guideline also upgrades the class of recommendation for left atrial appendage occlusion devices to 2a, compared with the 2019 AF Focused Update, for use of these devices in patients with long-term contraindications to anticoagulation.

It also provides updated recommendations for AF detected via implantable devices and wearables as well as recommendations for patients with AF identified during medical illness or surgery.

Development of the guideline had no commercial funding. Disclosures for the writing group are available with the original articles.

A version of this article appeared on Medscape.com.

The American College of Cardiology (ACC), the American Heart Association (AHA), the American College of Chest Physicians (ACCP), and the Heart Rhythm Society (HRS) have issued an updated guideline for preventing and optimally managing atrial fibrillation (AF).

The 2023 ACC/AHA/ACCP/HRS Guideline for Diagnosis and Management of Atrial Fibrillation was published online in the Journal of the American College of Cardiology and Circulation.

“The new guideline has important changes,” including a new way to classify AF, Jose Joglar, MD, professor of cardiac electrophysiology at UT Southwestern Medical Center in Dallas, Texas, and chair of the writing committee, said in an interview.

The previous classification was largely based only on arrhythmia duration and tended to emphasize specific therapeutic interventions rather than a more holistic and multidisciplinary management approach, Dr. Joglar explained.

The new proposed classification, using four stages, recognizes AF as a disease continuum that requires a variety of strategies at different stages, from prevention, lifestyle and risk factor modification, screening, and therapy.

Stage 1: At risk for AF due to the presence of risk factors

Stage 2: Pre-AF, with evidence of structural or electrical findings predisposing to AF

Stage 3: AF, including paroxysmal (3A), persistent (3B), long-standing persistent (3C), successful AF ablation (3D)

Stage 4: Permanent AF

The updated guideline recognizes lifestyle and risk factor modification as a “pillar” of AF management and offers “more prescriptive” recommendations, including management of obesity, weight loss, physical activity, smoking cessation, alcohol moderation, hypertension, and other comorbidities.

“We should not only be telling patients they need to be healthy, which doesn’t mean much to a patient, we need to tell them precisely what they need to do. For example, how much exercise to do or how much weight to lose to have a benefit,” Dr. Joglar said in an interview.

The good news for many people, he noted, is that coffee, which has had a “bad reputation,” is okay, as the latest data show it doesn’t seem to exacerbate AF.

The new guideline continues to endorse use of the CHA2DS2-VASc score as the predictor of choice to determine the risk of stroke, but it also allows for flexibility to use other calculators when uncertainty exists or when other risk factors, such as kidney disease, need to be included.

With the emergence of “new and consistent” evidence, the guideline also emphasizes the importance of early and continued management of patients with AF with a focus on maintaining sinus rhythm and minimizing AF burden.

Catheter ablation of AF is given a class 1 indication as first-line therapy in selected patients, including those with heart failure with reduced ejection fraction.

That’s based on recent randomized studies that have shown catheter ablation to be “superior to pharmacological therapy” for rhythm control in appropriately selected patients, Dr. Joglar told this news organization.

“There’s no need to try pharmacological therapies after a discussion between the patient and doctor and they decide that they want to proceed with the most effective intervention,” he added.

The new guideline also upgrades the class of recommendation for left atrial appendage occlusion devices to 2a, compared with the 2019 AF Focused Update, for use of these devices in patients with long-term contraindications to anticoagulation.

It also provides updated recommendations for AF detected via implantable devices and wearables as well as recommendations for patients with AF identified during medical illness or surgery.

Development of the guideline had no commercial funding. Disclosures for the writing group are available with the original articles.

A version of this article appeared on Medscape.com.

SAN DIEGO – In the spring of 2024, the American College of Rheumatology is expected to release guidelines to help inform the screening, monitoring, and treatment of interstitial lung disease (ILD) in people with systemic autoimmune rheumatic diseases (SARDs).

The guidelines, which were previewed during a session at the ACR’s annual meeting, will include 50 recommendations, 3 of which met criteria for a strong rating:

• For people with SARDs at increased risk of developing ILD, the authors strongly recommend against screening with surgical lung biopsy.
• For people with systemic sclerosis (SSc)-related ILD, the authors strongly recommend against glucocorticoids as a first-line ILD treatment.
• For people with SSc-related ILD progression despite an initial ILD treatment, the authors strongly recommend against using long-term glucocorticoids.

Elana J. Bernstein, MD, MSc, a rheumatologist who directs the Columbia/New York-Presbyterian Scleroderma Center, and Sindhu R. Johnson, MD, a rheumatologist who directs the Toronto Scleroderma Program at the University of Toronto, provided a sneak peek of the recommendations to attendees before anticipated publication in Arthritis & Rheumatology and Arthritis Care & Research. For now, guideline summaries for screening and monitoring and treatment are currently available, and three manuscripts are under peer review: one about screening and monitoring, one about treatment, and one about the patient panel that participated in the effort.

Pediatric patients with SARDs excluded

The guidelines’ population of interest was people 17 years of age and older who were diagnosed with SARDs with a high risk of ILD. Pediatric patients with SARDs were excluded from the endeavor, as were those with systemic lupus erythematosus, antineutrophil cytoplasmic antibody–associated vasculitis, sarcoidosis, ankylosing spondylitis, undifferentiated connective tissue disease, interstitial pneumonia with autoimmune features, and those with unclassifiable ILD.

In the realm of screening, the guideline authors conditionally recommend two screening tests for patients considered at increased risk of ILD: pulmonary function tests and high-resolution chest CT (HRCT). Pulmonary function tests should include spirometry, lung volumes, and diffusion capacity. “Office spirometry alone is insufficient,” said Dr. Johnson, who served as lead author of the guidelines. And while a HRCT scan is recommended, “some patients may present to the emergency room with acute onset shortness of breath, and they may receive a CT angiogram to screen for pulmonary embolism,” she said. “It’s important to note that CT angiograms are performed in incomplete inspiration to maximize pulmonary artery enhancement. This may produce atelectasis that may obscure or mimic ILD. As a result, CTA studies are often inadequate to screen for ILD.”

Once a patient is diagnosed with ILD, three tests are recommended for monitoring: pulmonary function testing (every 3-6 months the first year in patients with IIM and SSc, then less frequently once stable, and every 3-12 months in the first year in patients with RA, SjD, and MCTD, then less frequently once stable); ambulatory desaturation testing every 3-12 months; and HRCT as needed. Dr. Johnson noted that while that the screening of ILD lies within the realm of rheumatologists, “once a patient is diagnosed, we are encouraged to comanage these patients with pulmonologists,” she said. “Ambulatory desaturation testing is not an infrequent test in the hands of pulmonologists. This is where co-management can be helpful.” She characterized a 6-minute walk test with continuous oximetry as “insufficient and is not synonymous with ambulatory desaturation testing. Ambulatory desaturation testing includes up titration of oxygen if a patient desaturates.”

The guidelines conditionally recommend against using chest radiography, 6-minute walk test distance, ambulatory desaturation testing, and bronchoscopy for ILD screening, and there is a strong recommendation against surgical lung biopsy. “However, there are unique circumstances where these tests may be considered,” Dr. Johnson said. “For example, ambulatory desaturation testing may be helpful if a patient is unable to perform a pulmonary function test. Bronchoscopy may be used to rule out infection, sarcoidosis, lymphoma, or alveolar hemorrhage, and surgical lung biopsy may be considered if you’re trying to rule out a malignancy.”

Similarly, several tests are conditionally recommended against for the monitoring of ILD, including chest radiography, the 6-minute walk test distance, and bronchoscopy. “But there are unique circumstances where they may be considered,” she said. “The 6-minute walk test may be used if a patient is unable to perform a pulmonary function test or if they’re being assessed for lung transplantation. Bronchoscopy may be used to rule out infection or alveolar hemorrhage.”
 

Preferred treatment options described

First-line treatment recommendations for ILD were based on the best available published evidence, voting panel expertise, and patient preferences. For SSc, the preferred treatment options include mycophenolate (CellCept), tocilizumab (Actemra), or rituximab (Rituxan and biosimilars), while additional options include cyclophosphamide, nintedanib (Ofev), and azathioprine. For myositis, the preferred treatment options include mycophenolate, azathioprine, rituximab, or calcineurin inhibitors, while additional options include a Janus kinase (JAK) inhibitor or cyclophosphamide. For MCTD, the preferred treatment options include mycophenolate, azathioprine, or rituximab, while additional options include tocilizumab or cyclophosphamide. For RA and Sjögren’s, the preferred treatment options include mycophenolate, azathioprine, or rituximab, while additional options include cyclophosphamide. Dr. Johnson emphasized that there was low certainty evidence to recommend one treatment over another. “Many situations might lead a provider to choose a different option for ILD treatment, such as the presence of comorbidities or extra-pulmonary disease,” she said. “So, while our guidelines were focused on effectiveness for ILD, providers may choose therapies that will help ILD and other disease manifestations.”

The guidelines conditionally recommend a short course of glucocorticoids as a bridging therapy or for treatment of a flare of ILD in patients with myositis, MCTD, RA, and Sjögren’s. The panel strongly recommends against the use of glucocorticoids in patients with SSc due to the concern for inducing a scleroderma renal crisis. “While this may be common knowledge for rheumatologists, it may not be common knowledge for pulmonologists,” she said. “So here is an opportunity to educate our pulmonology colleagues in our consultation notes.”

The guidelines also include recommendations for progression of ILD, which was defined using the INBUILD trial criteria. Mycophenolate is conditionally recommended to be the first ILD treatment for all SARDs when progression occurs, if it wasn’t the first ILD treatment used. “If it was, then other medications that rheumatologists are used to can be considered as the next ILD treatment in the face of progression: rituximab, nintedanib, tocilizumab, and cyclophosphamide,” she said. The guidelines include a conditional recommendation against long-term glucocorticoid use in myositis, MCTD, RA, and Sjögren’s, plus a strong recommendation against long-term glucocorticoid use in SSc. Finally, there is a conditional recommendation of referral for lung transplant evaluation at the appropriate time at experienced centers.

University of Toronto

A patient panel provided input

For the undertaking, a core team that included six rheumatologists; one pulmonologist; one thoracic radiologist; one expert on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology; and two literature review experts developed clinically relevant population, intervention, comparator, and outcomes (PICO) questions. The literature review team included 13 rheumatologists, 8 pulmonologists, and 3 methodologists. Finally, a 21-member patient panel was convened to share their values and preferences regarding screening, monitoring, and treatment of SARD-related ILD. Of these, Dr. Bernstein said that 4 were at risk for ILD and 17 had been diagnosed with ILD. Next, the literature review team conducted a systematic review and used the GRADE methodology to rate the available evidence as high, moderate, low, or very low. Then, a voting panel comprising 13 rheumatologists, 10 pulmonologists, 1 radiologist, and 3 patients from the patient panel cast votes for each PICO question and made final recommendations.

The review of evidence left the guidelines authors with 241 PICO questions, “which is a lot,” Dr. Bernstein said. “To put this in perspective, some guidelines address only 10 or 15 PICO questions. Fortunately, we had a dedicated group of experts who were up to the challenge.” Dr. Johnson emphasized that the forthcoming guidelines should not be used by insurers to mandate a specific order of prescribing. “Clinicians must retain the latitude to prescribe medications based on individual patient factors and preferences,” she said.

Dr. Bernstein disclosed that she is an adviser to, a consultant for, and has received grant or research support from Boehringer Ingelheim and has also received grant or research support from Kadmon and Pfizer. Dr. Johnson disclosed that she has received research support from the American College of Rheumatology to develop these guidelines. She has also been an investigator for trials sponsored by Bristol-Myers Squibb, Roche, and Boehringer Ingelheim and has mitigated these relevant conflicts of interest 1 year prior to the development of these guidelines, and will continue to do so for the foreseeable future.

SAN DIEGO – In the spring of 2024, the American College of Rheumatology is expected to release guidelines to help inform the screening, monitoring, and treatment of interstitial lung disease (ILD) in people with systemic autoimmune rheumatic diseases (SARDs).

The guidelines, which were previewed during a session at the ACR’s annual meeting, will include 50 recommendations, 3 of which met criteria for a strong rating:

• For people with SARDs at increased risk of developing ILD, the authors strongly recommend against screening with surgical lung biopsy.
• For people with systemic sclerosis (SSc)-related ILD, the authors strongly recommend against glucocorticoids as a first-line ILD treatment.
• For people with SSc-related ILD progression despite an initial ILD treatment, the authors strongly recommend against using long-term glucocorticoids.

Elana J. Bernstein, MD, MSc, a rheumatologist who directs the Columbia/New York-Presbyterian Scleroderma Center, and Sindhu R. Johnson, MD, a rheumatologist who directs the Toronto Scleroderma Program at the University of Toronto, provided a sneak peek of the recommendations to attendees before anticipated publication in Arthritis & Rheumatology and Arthritis Care & Research. For now, guideline summaries for screening and monitoring and treatment are currently available, and three manuscripts are under peer review: one about screening and monitoring, one about treatment, and one about the patient panel that participated in the effort.

Pediatric patients with SARDs excluded

The guidelines’ population of interest was people 17 years of age and older who were diagnosed with SARDs with a high risk of ILD. Pediatric patients with SARDs were excluded from the endeavor, as were those with systemic lupus erythematosus, antineutrophil cytoplasmic antibody–associated vasculitis, sarcoidosis, ankylosing spondylitis, undifferentiated connective tissue disease, interstitial pneumonia with autoimmune features, and those with unclassifiable ILD.

In the realm of screening, the guideline authors conditionally recommend two screening tests for patients considered at increased risk of ILD: pulmonary function tests and high-resolution chest CT (HRCT). Pulmonary function tests should include spirometry, lung volumes, and diffusion capacity. “Office spirometry alone is insufficient,” said Dr. Johnson, who served as lead author of the guidelines. And while a HRCT scan is recommended, “some patients may present to the emergency room with acute onset shortness of breath, and they may receive a CT angiogram to screen for pulmonary embolism,” she said. “It’s important to note that CT angiograms are performed in incomplete inspiration to maximize pulmonary artery enhancement. This may produce atelectasis that may obscure or mimic ILD. As a result, CTA studies are often inadequate to screen for ILD.”

Once a patient is diagnosed with ILD, three tests are recommended for monitoring: pulmonary function testing (every 3-6 months the first year in patients with IIM and SSc, then less frequently once stable, and every 3-12 months in the first year in patients with RA, SjD, and MCTD, then less frequently once stable); ambulatory desaturation testing every 3-12 months; and HRCT as needed. Dr. Johnson noted that while that the screening of ILD lies within the realm of rheumatologists, “once a patient is diagnosed, we are encouraged to comanage these patients with pulmonologists,” she said. “Ambulatory desaturation testing is not an infrequent test in the hands of pulmonologists. This is where co-management can be helpful.” She characterized a 6-minute walk test with continuous oximetry as “insufficient and is not synonymous with ambulatory desaturation testing. Ambulatory desaturation testing includes up titration of oxygen if a patient desaturates.”

The guidelines conditionally recommend against using chest radiography, 6-minute walk test distance, ambulatory desaturation testing, and bronchoscopy for ILD screening, and there is a strong recommendation against surgical lung biopsy. “However, there are unique circumstances where these tests may be considered,” Dr. Johnson said. “For example, ambulatory desaturation testing may be helpful if a patient is unable to perform a pulmonary function test. Bronchoscopy may be used to rule out infection, sarcoidosis, lymphoma, or alveolar hemorrhage, and surgical lung biopsy may be considered if you’re trying to rule out a malignancy.”

Similarly, several tests are conditionally recommended against for the monitoring of ILD, including chest radiography, the 6-minute walk test distance, and bronchoscopy. “But there are unique circumstances where they may be considered,” she said. “The 6-minute walk test may be used if a patient is unable to perform a pulmonary function test or if they’re being assessed for lung transplantation. Bronchoscopy may be used to rule out infection or alveolar hemorrhage.”
 

Preferred treatment options described

First-line treatment recommendations for ILD were based on the best available published evidence, voting panel expertise, and patient preferences. For SSc, the preferred treatment options include mycophenolate (CellCept), tocilizumab (Actemra), or rituximab (Rituxan and biosimilars), while additional options include cyclophosphamide, nintedanib (Ofev), and azathioprine. For myositis, the preferred treatment options include mycophenolate, azathioprine, rituximab, or calcineurin inhibitors, while additional options include a Janus kinase (JAK) inhibitor or cyclophosphamide. For MCTD, the preferred treatment options include mycophenolate, azathioprine, or rituximab, while additional options include tocilizumab or cyclophosphamide. For RA and Sjögren’s, the preferred treatment options include mycophenolate, azathioprine, or rituximab, while additional options include cyclophosphamide. Dr. Johnson emphasized that there was low certainty evidence to recommend one treatment over another. “Many situations might lead a provider to choose a different option for ILD treatment, such as the presence of comorbidities or extra-pulmonary disease,” she said. “So, while our guidelines were focused on effectiveness for ILD, providers may choose therapies that will help ILD and other disease manifestations.”

The guidelines conditionally recommend a short course of glucocorticoids as a bridging therapy or for treatment of a flare of ILD in patients with myositis, MCTD, RA, and Sjögren’s. The panel strongly recommends against the use of glucocorticoids in patients with SSc due to the concern for inducing a scleroderma renal crisis. “While this may be common knowledge for rheumatologists, it may not be common knowledge for pulmonologists,” she said. “So here is an opportunity to educate our pulmonology colleagues in our consultation notes.”

The guidelines also include recommendations for progression of ILD, which was defined using the INBUILD trial criteria. Mycophenolate is conditionally recommended to be the first ILD treatment for all SARDs when progression occurs, if it wasn’t the first ILD treatment used. “If it was, then other medications that rheumatologists are used to can be considered as the next ILD treatment in the face of progression: rituximab, nintedanib, tocilizumab, and cyclophosphamide,” she said. The guidelines include a conditional recommendation against long-term glucocorticoid use in myositis, MCTD, RA, and Sjögren’s, plus a strong recommendation against long-term glucocorticoid use in SSc. Finally, there is a conditional recommendation of referral for lung transplant evaluation at the appropriate time at experienced centers.

University of Toronto

A patient panel provided input

For the undertaking, a core team that included six rheumatologists; one pulmonologist; one thoracic radiologist; one expert on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology; and two literature review experts developed clinically relevant population, intervention, comparator, and outcomes (PICO) questions. The literature review team included 13 rheumatologists, 8 pulmonologists, and 3 methodologists. Finally, a 21-member patient panel was convened to share their values and preferences regarding screening, monitoring, and treatment of SARD-related ILD. Of these, Dr. Bernstein said that 4 were at risk for ILD and 17 had been diagnosed with ILD. Next, the literature review team conducted a systematic review and used the GRADE methodology to rate the available evidence as high, moderate, low, or very low. Then, a voting panel comprising 13 rheumatologists, 10 pulmonologists, 1 radiologist, and 3 patients from the patient panel cast votes for each PICO question and made final recommendations.

The review of evidence left the guidelines authors with 241 PICO questions, “which is a lot,” Dr. Bernstein said. “To put this in perspective, some guidelines address only 10 or 15 PICO questions. Fortunately, we had a dedicated group of experts who were up to the challenge.” Dr. Johnson emphasized that the forthcoming guidelines should not be used by insurers to mandate a specific order of prescribing. “Clinicians must retain the latitude to prescribe medications based on individual patient factors and preferences,” she said.

Dr. Bernstein disclosed that she is an adviser to, a consultant for, and has received grant or research support from Boehringer Ingelheim and has also received grant or research support from Kadmon and Pfizer. Dr. Johnson disclosed that she has received research support from the American College of Rheumatology to develop these guidelines. She has also been an investigator for trials sponsored by Bristol-Myers Squibb, Roche, and Boehringer Ingelheim and has mitigated these relevant conflicts of interest 1 year prior to the development of these guidelines, and will continue to do so for the foreseeable future.

SAN DIEGO – In the spring of 2024, the American College of Rheumatology is expected to release guidelines to help inform the screening, monitoring, and treatment of interstitial lung disease (ILD) in people with systemic autoimmune rheumatic diseases (SARDs).

The guidelines, which were previewed during a session at the ACR’s annual meeting, will include 50 recommendations, 3 of which met criteria for a strong rating:

• For people with SARDs at increased risk of developing ILD, the authors strongly recommend against screening with surgical lung biopsy.
• For people with systemic sclerosis (SSc)-related ILD, the authors strongly recommend against glucocorticoids as a first-line ILD treatment.
• For people with SSc-related ILD progression despite an initial ILD treatment, the authors strongly recommend against using long-term glucocorticoids.

Elana J. Bernstein, MD, MSc, a rheumatologist who directs the Columbia/New York-Presbyterian Scleroderma Center, and Sindhu R. Johnson, MD, a rheumatologist who directs the Toronto Scleroderma Program at the University of Toronto, provided a sneak peek of the recommendations to attendees before anticipated publication in Arthritis & Rheumatology and Arthritis Care & Research. For now, guideline summaries for screening and monitoring and treatment are currently available, and three manuscripts are under peer review: one about screening and monitoring, one about treatment, and one about the patient panel that participated in the effort.

Pediatric patients with SARDs excluded

The guidelines’ population of interest was people 17 years of age and older who were diagnosed with SARDs with a high risk of ILD. Pediatric patients with SARDs were excluded from the endeavor, as were those with systemic lupus erythematosus, antineutrophil cytoplasmic antibody–associated vasculitis, sarcoidosis, ankylosing spondylitis, undifferentiated connective tissue disease, interstitial pneumonia with autoimmune features, and those with unclassifiable ILD.

In the realm of screening, the guideline authors conditionally recommend two screening tests for patients considered at increased risk of ILD: pulmonary function tests and high-resolution chest CT (HRCT). Pulmonary function tests should include spirometry, lung volumes, and diffusion capacity. “Office spirometry alone is insufficient,” said Dr. Johnson, who served as lead author of the guidelines. And while a HRCT scan is recommended, “some patients may present to the emergency room with acute onset shortness of breath, and they may receive a CT angiogram to screen for pulmonary embolism,” she said. “It’s important to note that CT angiograms are performed in incomplete inspiration to maximize pulmonary artery enhancement. This may produce atelectasis that may obscure or mimic ILD. As a result, CTA studies are often inadequate to screen for ILD.”

Once a patient is diagnosed with ILD, three tests are recommended for monitoring: pulmonary function testing (every 3-6 months the first year in patients with IIM and SSc, then less frequently once stable, and every 3-12 months in the first year in patients with RA, SjD, and MCTD, then less frequently once stable); ambulatory desaturation testing every 3-12 months; and HRCT as needed. Dr. Johnson noted that while that the screening of ILD lies within the realm of rheumatologists, “once a patient is diagnosed, we are encouraged to comanage these patients with pulmonologists,” she said. “Ambulatory desaturation testing is not an infrequent test in the hands of pulmonologists. This is where co-management can be helpful.” She characterized a 6-minute walk test with continuous oximetry as “insufficient and is not synonymous with ambulatory desaturation testing. Ambulatory desaturation testing includes up titration of oxygen if a patient desaturates.”

The guidelines conditionally recommend against using chest radiography, 6-minute walk test distance, ambulatory desaturation testing, and bronchoscopy for ILD screening, and there is a strong recommendation against surgical lung biopsy. “However, there are unique circumstances where these tests may be considered,” Dr. Johnson said. “For example, ambulatory desaturation testing may be helpful if a patient is unable to perform a pulmonary function test. Bronchoscopy may be used to rule out infection, sarcoidosis, lymphoma, or alveolar hemorrhage, and surgical lung biopsy may be considered if you’re trying to rule out a malignancy.”

Similarly, several tests are conditionally recommended against for the monitoring of ILD, including chest radiography, the 6-minute walk test distance, and bronchoscopy. “But there are unique circumstances where they may be considered,” she said. “The 6-minute walk test may be used if a patient is unable to perform a pulmonary function test or if they’re being assessed for lung transplantation. Bronchoscopy may be used to rule out infection or alveolar hemorrhage.”
 

Preferred treatment options described

First-line treatment recommendations for ILD were based on the best available published evidence, voting panel expertise, and patient preferences. For SSc, the preferred treatment options include mycophenolate (CellCept), tocilizumab (Actemra), or rituximab (Rituxan and biosimilars), while additional options include cyclophosphamide, nintedanib (Ofev), and azathioprine. For myositis, the preferred treatment options include mycophenolate, azathioprine, rituximab, or calcineurin inhibitors, while additional options include a Janus kinase (JAK) inhibitor or cyclophosphamide. For MCTD, the preferred treatment options include mycophenolate, azathioprine, or rituximab, while additional options include tocilizumab or cyclophosphamide. For RA and Sjögren’s, the preferred treatment options include mycophenolate, azathioprine, or rituximab, while additional options include cyclophosphamide. Dr. Johnson emphasized that there was low certainty evidence to recommend one treatment over another. “Many situations might lead a provider to choose a different option for ILD treatment, such as the presence of comorbidities or extra-pulmonary disease,” she said. “So, while our guidelines were focused on effectiveness for ILD, providers may choose therapies that will help ILD and other disease manifestations.”

The guidelines conditionally recommend a short course of glucocorticoids as a bridging therapy or for treatment of a flare of ILD in patients with myositis, MCTD, RA, and Sjögren’s. The panel strongly recommends against the use of glucocorticoids in patients with SSc due to the concern for inducing a scleroderma renal crisis. “While this may be common knowledge for rheumatologists, it may not be common knowledge for pulmonologists,” she said. “So here is an opportunity to educate our pulmonology colleagues in our consultation notes.”

The guidelines also include recommendations for progression of ILD, which was defined using the INBUILD trial criteria. Mycophenolate is conditionally recommended to be the first ILD treatment for all SARDs when progression occurs, if it wasn’t the first ILD treatment used. “If it was, then other medications that rheumatologists are used to can be considered as the next ILD treatment in the face of progression: rituximab, nintedanib, tocilizumab, and cyclophosphamide,” she said. The guidelines include a conditional recommendation against long-term glucocorticoid use in myositis, MCTD, RA, and Sjögren’s, plus a strong recommendation against long-term glucocorticoid use in SSc. Finally, there is a conditional recommendation of referral for lung transplant evaluation at the appropriate time at experienced centers.

University of Toronto

A patient panel provided input

For the undertaking, a core team that included six rheumatologists; one pulmonologist; one thoracic radiologist; one expert on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology; and two literature review experts developed clinically relevant population, intervention, comparator, and outcomes (PICO) questions. The literature review team included 13 rheumatologists, 8 pulmonologists, and 3 methodologists. Finally, a 21-member patient panel was convened to share their values and preferences regarding screening, monitoring, and treatment of SARD-related ILD. Of these, Dr. Bernstein said that 4 were at risk for ILD and 17 had been diagnosed with ILD. Next, the literature review team conducted a systematic review and used the GRADE methodology to rate the available evidence as high, moderate, low, or very low. Then, a voting panel comprising 13 rheumatologists, 10 pulmonologists, 1 radiologist, and 3 patients from the patient panel cast votes for each PICO question and made final recommendations.

The review of evidence left the guidelines authors with 241 PICO questions, “which is a lot,” Dr. Bernstein said. “To put this in perspective, some guidelines address only 10 or 15 PICO questions. Fortunately, we had a dedicated group of experts who were up to the challenge.” Dr. Johnson emphasized that the forthcoming guidelines should not be used by insurers to mandate a specific order of prescribing. “Clinicians must retain the latitude to prescribe medications based on individual patient factors and preferences,” she said.

Dr. Bernstein disclosed that she is an adviser to, a consultant for, and has received grant or research support from Boehringer Ingelheim and has also received grant or research support from Kadmon and Pfizer. Dr. Johnson disclosed that she has received research support from the American College of Rheumatology to develop these guidelines. She has also been an investigator for trials sponsored by Bristol-Myers Squibb, Roche, and Boehringer Ingelheim and has mitigated these relevant conflicts of interest 1 year prior to the development of these guidelines, and will continue to do so for the foreseeable future.

SAN DIEGO – The Spondyloarthritis Research and Treatment Network (SPARTAN) has created the first referral recommendations for axial spondyloarthritis (axSpA).

The draft recommendations use a points scoring system, with the goal that at least one in three patients referred would be diagnosed with axSpA, an inflammatory arthritis that affects the central skeleton and shares a genetic overlap with skin psoriasis, inflammatory bowel disease, and inflammatory eye disease.

Lucy Hicks/Medscape Medical News

Patients with axSpA can wait 10 years after symptom onset to be diagnosed with the condition. There are currently no guidelines to advise clinicians on when to refer to a rheumatologist, and with the rheumatology workforce shortage, “it is impossible for rheumatologists to evaluate the 20% of adults in the U.S. who have chronic back pain,” said Maureen Dubreuil, MD, a rheumatologist at Boston University. She presented the work at the annual meeting of the American College of Rheumatology. 

To address this issue, Dr. Dubreuil and colleagues conducted a literature review to determine how predictive different spondyloarthritis features were of eventual axSpA diagnosis. The interdisciplinary team identified 38 studies published before March 2022, and uncovered 28 individual potential features associated with axSpA, including pain sites, family history of axSpA and related conditions, blood markers of inflammation, genetic testing, and imaging findings.

Inflammatory back pain elements had the lower predictive values, with positive likelihood ratios (LR+) ranging from 1.15 to 2.32, while imaging findings were the most predictive (LR+s from 6.40 to 10.02).

Using a Delphi exercise and discrete choice experiments, members narrowed the checklist down to 10 features. These 10 features were assigned points, with a score of 3 points qualifying for a referral of adults 45 years or younger with chronic pain (3 or more months) in the back, hip, or buttock.

SAN DIEGO – The Spondyloarthritis Research and Treatment Network (SPARTAN) has created the first referral recommendations for axial spondyloarthritis (axSpA).

The draft recommendations use a points scoring system, with the goal that at least one in three patients referred would be diagnosed with axSpA, an inflammatory arthritis that affects the central skeleton and shares a genetic overlap with skin psoriasis, inflammatory bowel disease, and inflammatory eye disease.

Lucy Hicks/Medscape Medical News

Patients with axSpA can wait 10 years after symptom onset to be diagnosed with the condition. There are currently no guidelines to advise clinicians on when to refer to a rheumatologist, and with the rheumatology workforce shortage, “it is impossible for rheumatologists to evaluate the 20% of adults in the U.S. who have chronic back pain,” said Maureen Dubreuil, MD, a rheumatologist at Boston University. She presented the work at the annual meeting of the American College of Rheumatology. 

To address this issue, Dr. Dubreuil and colleagues conducted a literature review to determine how predictive different spondyloarthritis features were of eventual axSpA diagnosis. The interdisciplinary team identified 38 studies published before March 2022, and uncovered 28 individual potential features associated with axSpA, including pain sites, family history of axSpA and related conditions, blood markers of inflammation, genetic testing, and imaging findings.

Inflammatory back pain elements had the lower predictive values, with positive likelihood ratios (LR+) ranging from 1.15 to 2.32, while imaging findings were the most predictive (LR+s from 6.40 to 10.02).

Using a Delphi exercise and discrete choice experiments, members narrowed the checklist down to 10 features. These 10 features were assigned points, with a score of 3 points qualifying for a referral of adults 45 years or younger with chronic pain (3 or more months) in the back, hip, or buttock.

SAN DIEGO – The Spondyloarthritis Research and Treatment Network (SPARTAN) has created the first referral recommendations for axial spondyloarthritis (axSpA).

The draft recommendations use a points scoring system, with the goal that at least one in three patients referred would be diagnosed with axSpA, an inflammatory arthritis that affects the central skeleton and shares a genetic overlap with skin psoriasis, inflammatory bowel disease, and inflammatory eye disease.

Lucy Hicks/Medscape Medical News

Patients with axSpA can wait 10 years after symptom onset to be diagnosed with the condition. There are currently no guidelines to advise clinicians on when to refer to a rheumatologist, and with the rheumatology workforce shortage, “it is impossible for rheumatologists to evaluate the 20% of adults in the U.S. who have chronic back pain,” said Maureen Dubreuil, MD, a rheumatologist at Boston University. She presented the work at the annual meeting of the American College of Rheumatology. 

To address this issue, Dr. Dubreuil and colleagues conducted a literature review to determine how predictive different spondyloarthritis features were of eventual axSpA diagnosis. The interdisciplinary team identified 38 studies published before March 2022, and uncovered 28 individual potential features associated with axSpA, including pain sites, family history of axSpA and related conditions, blood markers of inflammation, genetic testing, and imaging findings.

Inflammatory back pain elements had the lower predictive values, with positive likelihood ratios (LR+) ranging from 1.15 to 2.32, while imaging findings were the most predictive (LR+s from 6.40 to 10.02).

Using a Delphi exercise and discrete choice experiments, members narrowed the checklist down to 10 features. These 10 features were assigned points, with a score of 3 points qualifying for a referral of adults 45 years or younger with chronic pain (3 or more months) in the back, hip, or buttock.

Popular new glucagon-like peptide 1 receptor agonists require some pre-procedure considerations but not necessarily discontinuation of the drugs to support the success of endoscopic procedures, according to a new Clinical Practice Update from the American Gastroenterological Association.

Use of glucagon-like peptide 1 (GLP-1) receptor agonists (GLP-1 RAs) has been associated with delayed gastric emptying, which raises a clinical concern about performing endoscopic procedures, especially upper endoscopies in patients using these medications, wrote Jana G. Al Hashash, MD, MSc, of the Mayo Clinic, Jacksonville, Fla., and colleagues.

The Clinical Practice Update (CPU), published in Clinical Gastroenterology and Hepatology, reviews the evidence and provides expert advice for clinicians on the evolving landscape of patients taking GLP-1 receptor agonists prior to endoscopic procedures. The CPU reflects on the most recent literature and the experience of the authors, all experts in bariatric medicine and/or endoscopy.

The American Society of Anesthesiologists (ASA) issued guidance that reflects concerns for the risk of aspiration in sedated patients because of delayed gastric motility from the use of GLP-1 RAs. The ASA advises patients on daily doses of GLP-1 RAs to refrain from taking the medications on the day of a procedure; those on weekly dosing should hold the drugs for a week prior to surgery.

However, the ASA suggestions do not differentiate based on the indication for the drug or for the type of procedure, and questions remain as to whether these changes are necessary and/or effective, the CPU authors said. The ASA’s guidance is based mainly on expert opinion, as not enough published evidence on this topic exists for a robust review and formal guideline, they added.

Recently, a multisociety statement from the AGA, AASLD, ACG, ASGE, and NASPGHAN noted that widespread implementation of the ASA guidance could be associated with unintended harms to patients.

Therefore, the AGA CPU suggests an individualized approach to managing patients on GLP-1 RAs in a pre-endoscopic setting.

For patients on GLP-1 RAs for diabetes management, discontinuing prior to endoscopic may not be worth the potential risk. Also, consider not only the dose and frequency of the GLP-1 RAs but also other comorbidities, medications, and potential gastrointestinal side effects.

“If patients taking GLP-1 RAs solely for weight loss can be identified beforehand, a dose of the medication could be withheld prior to endoscopy with likely little harm, though this should not be considered mandatory or evidence-based,” the CPU authors wrote.

However, withholding a single dose of medication may not be enough for an individual’s gastric motility to return to normal, the authors emphasized.

Additionally, the ASA’s suggestions for holding GLP-1 RAs add complexity to periprocedural medication management, which may strain resources and delay care.

The AGA CPU offers the following guidance for patients on GLP-1 RAs prior to endoscopy:

In general, patients using GLP-1 RAs who have followed the standard perioperative procedures, usually an 8-hour solid-food fast and 2-hour liquid fast, and who do not have symptoms such as ongoing nausea, vomiting, or abdominal distension should proceed with upper and/or lower endoscopy.

For symptomatic patients who may experience negative clinical consequences of endoscopy if delayed, consider rapid-sequence intubation, but the authors acknowledge that this option may not be possible in most ambulatory or office-based endoscopy settings.

Finally, consider placing patients on a liquid diet the day before a sedated procedure instead of stopping GLP-1 RAs; this strategy is “more consistent with the holistic approach to preprocedural management of other similar condi-tions,” the authors said.

The current CPU endorses the multi-society statement that puts patient safety first and encourages AGA members to follow best practices when performing endoscopies on patients who are using GLP-1 RAs, in the absence of actionable data, the authors concluded.

The Clinical Practice Update received no outside funding. Lead author Dr. Al Hashash had no financial conflicts to disclose.

Popular new glucagon-like peptide 1 receptor agonists require some pre-procedure considerations but not necessarily discontinuation of the drugs to support the success of endoscopic procedures, according to a new Clinical Practice Update from the American Gastroenterological Association.

Use of glucagon-like peptide 1 (GLP-1) receptor agonists (GLP-1 RAs) has been associated with delayed gastric emptying, which raises a clinical concern about performing endoscopic procedures, especially upper endoscopies in patients using these medications, wrote Jana G. Al Hashash, MD, MSc, of the Mayo Clinic, Jacksonville, Fla., and colleagues.

The Clinical Practice Update (CPU), published in Clinical Gastroenterology and Hepatology, reviews the evidence and provides expert advice for clinicians on the evolving landscape of patients taking GLP-1 receptor agonists prior to endoscopic procedures. The CPU reflects on the most recent literature and the experience of the authors, all experts in bariatric medicine and/or endoscopy.

The American Society of Anesthesiologists (ASA) issued guidance that reflects concerns for the risk of aspiration in sedated patients because of delayed gastric motility from the use of GLP-1 RAs. The ASA advises patients on daily doses of GLP-1 RAs to refrain from taking the medications on the day of a procedure; those on weekly dosing should hold the drugs for a week prior to surgery.

However, the ASA suggestions do not differentiate based on the indication for the drug or for the type of procedure, and questions remain as to whether these changes are necessary and/or effective, the CPU authors said. The ASA’s guidance is based mainly on expert opinion, as not enough published evidence on this topic exists for a robust review and formal guideline, they added.

Recently, a multisociety statement from the AGA, AASLD, ACG, ASGE, and NASPGHAN noted that widespread implementation of the ASA guidance could be associated with unintended harms to patients.

Therefore, the AGA CPU suggests an individualized approach to managing patients on GLP-1 RAs in a pre-endoscopic setting.

For patients on GLP-1 RAs for diabetes management, discontinuing prior to endoscopic may not be worth the potential risk. Also, consider not only the dose and frequency of the GLP-1 RAs but also other comorbidities, medications, and potential gastrointestinal side effects.

“If patients taking GLP-1 RAs solely for weight loss can be identified beforehand, a dose of the medication could be withheld prior to endoscopy with likely little harm, though this should not be considered mandatory or evidence-based,” the CPU authors wrote.

However, withholding a single dose of medication may not be enough for an individual’s gastric motility to return to normal, the authors emphasized.

Additionally, the ASA’s suggestions for holding GLP-1 RAs add complexity to periprocedural medication management, which may strain resources and delay care.

The AGA CPU offers the following guidance for patients on GLP-1 RAs prior to endoscopy:

In general, patients using GLP-1 RAs who have followed the standard perioperative procedures, usually an 8-hour solid-food fast and 2-hour liquid fast, and who do not have symptoms such as ongoing nausea, vomiting, or abdominal distension should proceed with upper and/or lower endoscopy.

For symptomatic patients who may experience negative clinical consequences of endoscopy if delayed, consider rapid-sequence intubation, but the authors acknowledge that this option may not be possible in most ambulatory or office-based endoscopy settings.

Finally, consider placing patients on a liquid diet the day before a sedated procedure instead of stopping GLP-1 RAs; this strategy is “more consistent with the holistic approach to preprocedural management of other similar condi-tions,” the authors said.

The current CPU endorses the multi-society statement that puts patient safety first and encourages AGA members to follow best practices when performing endoscopies on patients who are using GLP-1 RAs, in the absence of actionable data, the authors concluded.

The Clinical Practice Update received no outside funding. Lead author Dr. Al Hashash had no financial conflicts to disclose.

Popular new glucagon-like peptide 1 receptor agonists require some pre-procedure considerations but not necessarily discontinuation of the drugs to support the success of endoscopic procedures, according to a new Clinical Practice Update from the American Gastroenterological Association.

Use of glucagon-like peptide 1 (GLP-1) receptor agonists (GLP-1 RAs) has been associated with delayed gastric emptying, which raises a clinical concern about performing endoscopic procedures, especially upper endoscopies in patients using these medications, wrote Jana G. Al Hashash, MD, MSc, of the Mayo Clinic, Jacksonville, Fla., and colleagues.

The Clinical Practice Update (CPU), published in Clinical Gastroenterology and Hepatology, reviews the evidence and provides expert advice for clinicians on the evolving landscape of patients taking GLP-1 receptor agonists prior to endoscopic procedures. The CPU reflects on the most recent literature and the experience of the authors, all experts in bariatric medicine and/or endoscopy.

The American Society of Anesthesiologists (ASA) issued guidance that reflects concerns for the risk of aspiration in sedated patients because of delayed gastric motility from the use of GLP-1 RAs. The ASA advises patients on daily doses of GLP-1 RAs to refrain from taking the medications on the day of a procedure; those on weekly dosing should hold the drugs for a week prior to surgery.

However, the ASA suggestions do not differentiate based on the indication for the drug or for the type of procedure, and questions remain as to whether these changes are necessary and/or effective, the CPU authors said. The ASA’s guidance is based mainly on expert opinion, as not enough published evidence on this topic exists for a robust review and formal guideline, they added.

Recently, a multisociety statement from the AGA, AASLD, ACG, ASGE, and NASPGHAN noted that widespread implementation of the ASA guidance could be associated with unintended harms to patients.

Therefore, the AGA CPU suggests an individualized approach to managing patients on GLP-1 RAs in a pre-endoscopic setting.

For patients on GLP-1 RAs for diabetes management, discontinuing prior to endoscopic may not be worth the potential risk. Also, consider not only the dose and frequency of the GLP-1 RAs but also other comorbidities, medications, and potential gastrointestinal side effects.

“If patients taking GLP-1 RAs solely for weight loss can be identified beforehand, a dose of the medication could be withheld prior to endoscopy with likely little harm, though this should not be considered mandatory or evidence-based,” the CPU authors wrote.

However, withholding a single dose of medication may not be enough for an individual’s gastric motility to return to normal, the authors emphasized.

Additionally, the ASA’s suggestions for holding GLP-1 RAs add complexity to periprocedural medication management, which may strain resources and delay care.

The AGA CPU offers the following guidance for patients on GLP-1 RAs prior to endoscopy:

In general, patients using GLP-1 RAs who have followed the standard perioperative procedures, usually an 8-hour solid-food fast and 2-hour liquid fast, and who do not have symptoms such as ongoing nausea, vomiting, or abdominal distension should proceed with upper and/or lower endoscopy.

For symptomatic patients who may experience negative clinical consequences of endoscopy if delayed, consider rapid-sequence intubation, but the authors acknowledge that this option may not be possible in most ambulatory or office-based endoscopy settings.

Finally, consider placing patients on a liquid diet the day before a sedated procedure instead of stopping GLP-1 RAs; this strategy is “more consistent with the holistic approach to preprocedural management of other similar condi-tions,” the authors said.

The current CPU endorses the multi-society statement that puts patient safety first and encourages AGA members to follow best practices when performing endoscopies on patients who are using GLP-1 RAs, in the absence of actionable data, the authors concluded.

The Clinical Practice Update received no outside funding. Lead author Dr. Al Hashash had no financial conflicts to disclose.

New guidelines on determining brain death offer the first updated recommendations in more than a decade for adult and pediatric patients.

The consensus practice guideline on brain death, also known as death by neurologic criteria (BD/DNC), was developed by a panel of 20 experts from different specialties, institutions, and medical societies.

As with previous guidelines, the updated version stipulates that brain death should be declared when a patient with a known cause of catastrophic brain injury has permanent loss of function of the brain, including the brain stem, which results in coma, brain stem areflexia, and apnea in the setting of an adequate stimulus.

But the updated version also clarifies questions on neurological examinations and apnea testing and offers new guidance on pre-evaluation targets for blood pressure and body temperature and evaluating brain death in patients who are pregnant, are on extracorporeal membrane oxygenation, or have an injury to the base of the brain.

Also, for the first time, the guidance clarifies that clinicians don’t need to obtain consent before performing a brain death evaluation, unless institutional policy, state laws, or regulations stipulate otherwise.

“The 2023 guidelines will be considered the standard of care in the U.S.,” lead author David M. Greer, MD, chair and chief of neurology, Boston University, and chief of neurology, Boston Medical Center, said in an interview. “Each hospital in the U.S. is responsible for its own policy for BD/DNC determination, and our hope is that they will quickly revise their policies in accordance with this new national standard.”

The guidelines, which are accompanied by a three-page checklist and a free digital app, were published online in Neurology.
 

Four years in the making

Work on the 85 recommendations in the new report began more than 4 years ago as a collaborative effort by the American Academy of Neurology, the American Academy of Pediatrics, the Child Neurology Society, and the Society of Critical Care Medicine.

A lack of high-quality evidence on brain death determination led panelists to devise an evidence-informed formal consensus process to develop the guidelines, which involved three rounds of anonymous voting on each recommendation and the rationales behind them.

The strength of each recommendation was based on the level of consensus reached through voting, with Level A denoting a recommendation that “must” be followed, Level B one that “should” be followed, and Level C one that “may” be followed.

The majority of recommendations received an A or B rating. Only one recommendation, about whether a second clinical exam is needed in adults, garnered a C rating.

In children, the guidelines recommend that clinicians must perform two clinical examinations and two apnea tests 12 hours apart. In adults, only one exam is required. Both of those recommendations were rated Level A. A recommendation for a second exam in adults received the single Level C rating.
 

A uniform set of guidelines?

The new guidelines replace adult practice guidance published by AAN in 2010 and guideline for infants and children released in 2011 by AAP, CNS, and SCCM, and for the first time combine brain death guidelines for adult and pediatric patients into one document.

“It is important for clinicians to review the new guideline carefully and ensure their hospital brain death guidelines are updated to be consistent with the new guideline in order to prevent inaccurate determinations of death,” guidelines coauthor Ariane Lewis, MD, NYU Langone Health, New York, said in an interview.

The 1981 Uniform Determination of Death Act (UDDA) is the legal foundation for the declaration of BD/DNC in the United States, but it only stipulates that brain death determination must be made in accordance with accepted medical standards.

There is no single national standard, and states and hospitals are free to adopt their own, which many have done. One goal of the new guidelines was to create a uniform set of guidelines that all institutions follow.

“This is a step toward having a set of guidelines that are accepted by most of the societies and clinical specialties involved in this sort of diagnosis,” that could lead to a national-level policy, Fernando Goldenberg, MD, professor of neurology and director of neuroscience critical care, University of Chicago Medicine, said in an interview.

Dr. Goldenberg was not part of the panel that developed the updated guidelines, but was a coauthor of a consensus statement from the World Brain Death Project in 2020.

Developing a singular global guideline for brain death determination is unlikely, Dr. Goldenberg said. Policies vary widely across the world, and some countries don’t even recognize brain death.

“But this attempts to unify things at the U.S. level, which is very important,” he said.
 

Permanent vs. irreversible

Dr. Goldenberg said that combining adult and pediatric guidelines into one document will be very helpful for clinicians like him who treat patients from age 16 years and up.

The expanded guidance on apnea testing, recommendations on specific ancillary tests to use or avoid, and inclusion of language stipulating that prior consent is not needed to perform a brain death evaluation are also useful.

He also noted that the section on credentialing and training of clinicians who perform BD/DNC evaluations recognizes advanced practice providers, the first time he recalls seeing these professionals included in brain death guidelines.

However, the panel’s decision to use the term “permanent” to describe loss of brain function instead of “irreversible” gave Dr. Goldenberg pause.

The UDDA provides that an individual is declared legally dead when “circulatory and respiratory functions irreversibly stop; or all functions of the entire brain, including the brain stem, irreversibly stop.”

Earlier in October, the American College of Physicians released a position paper on cardiorespiratory death determination that called for a revision of the UDDA language.

The ACP suggested that “irreversibly” be replaced with “permanently” with regard to the cessation of circulatory and respiratory functions, but that “irreversible” be kept in the description of brain death.

“Permanent means that there is damage that is potentially reversible and irreversible means that the damage is so profound, it cannot be reversed even if an attempt to do so is performed,” Dr. Goldenberg said.

Even though the World Brain Death Project, on which he worked, also used “permanent” to describe brain function loss, Dr. Goldenberg said he aligns with ACP’s position.

“The understanding of brain death is that the damage is so profound, it is irreversible, even if you were to try,” he said. “Therefore, I think that the most appropriate term for brain death should be irreversible as opposed to permanent.”

The report was funded by the American Academy of Neurology. Dr. Greer has received travel funding from Boston University; serves as editor-in-chief for Seminars in Neurology; receives publishing royalties for 50 Studies Every Neurologist Should Know and Successful Leadership in Academic Medicine; has received honoraria from AAN; has received research funding from Becton, Dickinson, and Company; and has served as expert witness in legal proceedings. Dr. Lewis has received honoraria from AAN and Neurodiem, serves as Neurology deputy editor of disputes and debates, and serves as deputy editor of seminars in Neurology. Dr. Goldenberg reported no relevant financial relationships.

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

New guidelines on determining brain death offer the first updated recommendations in more than a decade for adult and pediatric patients.

The consensus practice guideline on brain death, also known as death by neurologic criteria (BD/DNC), was developed by a panel of 20 experts from different specialties, institutions, and medical societies.

As with previous guidelines, the updated version stipulates that brain death should be declared when a patient with a known cause of catastrophic brain injury has permanent loss of function of the brain, including the brain stem, which results in coma, brain stem areflexia, and apnea in the setting of an adequate stimulus.

But the updated version also clarifies questions on neurological examinations and apnea testing and offers new guidance on pre-evaluation targets for blood pressure and body temperature and evaluating brain death in patients who are pregnant, are on extracorporeal membrane oxygenation, or have an injury to the base of the brain.

Also, for the first time, the guidance clarifies that clinicians don’t need to obtain consent before performing a brain death evaluation, unless institutional policy, state laws, or regulations stipulate otherwise.

“The 2023 guidelines will be considered the standard of care in the U.S.,” lead author David M. Greer, MD, chair and chief of neurology, Boston University, and chief of neurology, Boston Medical Center, said in an interview. “Each hospital in the U.S. is responsible for its own policy for BD/DNC determination, and our hope is that they will quickly revise their policies in accordance with this new national standard.”

The guidelines, which are accompanied by a three-page checklist and a free digital app, were published online in Neurology.
 

Four years in the making

Work on the 85 recommendations in the new report began more than 4 years ago as a collaborative effort by the American Academy of Neurology, the American Academy of Pediatrics, the Child Neurology Society, and the Society of Critical Care Medicine.

A lack of high-quality evidence on brain death determination led panelists to devise an evidence-informed formal consensus process to develop the guidelines, which involved three rounds of anonymous voting on each recommendation and the rationales behind them.

The strength of each recommendation was based on the level of consensus reached through voting, with Level A denoting a recommendation that “must” be followed, Level B one that “should” be followed, and Level C one that “may” be followed.

The majority of recommendations received an A or B rating. Only one recommendation, about whether a second clinical exam is needed in adults, garnered a C rating.

In children, the guidelines recommend that clinicians must perform two clinical examinations and two apnea tests 12 hours apart. In adults, only one exam is required. Both of those recommendations were rated Level A. A recommendation for a second exam in adults received the single Level C rating.
 

A uniform set of guidelines?

The new guidelines replace adult practice guidance published by AAN in 2010 and guideline for infants and children released in 2011 by AAP, CNS, and SCCM, and for the first time combine brain death guidelines for adult and pediatric patients into one document.

“It is important for clinicians to review the new guideline carefully and ensure their hospital brain death guidelines are updated to be consistent with the new guideline in order to prevent inaccurate determinations of death,” guidelines coauthor Ariane Lewis, MD, NYU Langone Health, New York, said in an interview.

The 1981 Uniform Determination of Death Act (UDDA) is the legal foundation for the declaration of BD/DNC in the United States, but it only stipulates that brain death determination must be made in accordance with accepted medical standards.

There is no single national standard, and states and hospitals are free to adopt their own, which many have done. One goal of the new guidelines was to create a uniform set of guidelines that all institutions follow.

“This is a step toward having a set of guidelines that are accepted by most of the societies and clinical specialties involved in this sort of diagnosis,” that could lead to a national-level policy, Fernando Goldenberg, MD, professor of neurology and director of neuroscience critical care, University of Chicago Medicine, said in an interview.

Dr. Goldenberg was not part of the panel that developed the updated guidelines, but was a coauthor of a consensus statement from the World Brain Death Project in 2020.

Developing a singular global guideline for brain death determination is unlikely, Dr. Goldenberg said. Policies vary widely across the world, and some countries don’t even recognize brain death.

“But this attempts to unify things at the U.S. level, which is very important,” he said.
 

Permanent vs. irreversible

Dr. Goldenberg said that combining adult and pediatric guidelines into one document will be very helpful for clinicians like him who treat patients from age 16 years and up.

The expanded guidance on apnea testing, recommendations on specific ancillary tests to use or avoid, and inclusion of language stipulating that prior consent is not needed to perform a brain death evaluation are also useful.

He also noted that the section on credentialing and training of clinicians who perform BD/DNC evaluations recognizes advanced practice providers, the first time he recalls seeing these professionals included in brain death guidelines.

However, the panel’s decision to use the term “permanent” to describe loss of brain function instead of “irreversible” gave Dr. Goldenberg pause.

The UDDA provides that an individual is declared legally dead when “circulatory and respiratory functions irreversibly stop; or all functions of the entire brain, including the brain stem, irreversibly stop.”

Earlier in October, the American College of Physicians released a position paper on cardiorespiratory death determination that called for a revision of the UDDA language.

The ACP suggested that “irreversibly” be replaced with “permanently” with regard to the cessation of circulatory and respiratory functions, but that “irreversible” be kept in the description of brain death.

“Permanent means that there is damage that is potentially reversible and irreversible means that the damage is so profound, it cannot be reversed even if an attempt to do so is performed,” Dr. Goldenberg said.

Even though the World Brain Death Project, on which he worked, also used “permanent” to describe brain function loss, Dr. Goldenberg said he aligns with ACP’s position.

“The understanding of brain death is that the damage is so profound, it is irreversible, even if you were to try,” he said. “Therefore, I think that the most appropriate term for brain death should be irreversible as opposed to permanent.”

The report was funded by the American Academy of Neurology. Dr. Greer has received travel funding from Boston University; serves as editor-in-chief for Seminars in Neurology; receives publishing royalties for 50 Studies Every Neurologist Should Know and Successful Leadership in Academic Medicine; has received honoraria from AAN; has received research funding from Becton, Dickinson, and Company; and has served as expert witness in legal proceedings. Dr. Lewis has received honoraria from AAN and Neurodiem, serves as Neurology deputy editor of disputes and debates, and serves as deputy editor of seminars in Neurology. Dr. Goldenberg reported no relevant financial relationships.

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

New guidelines on determining brain death offer the first updated recommendations in more than a decade for adult and pediatric patients.

The consensus practice guideline on brain death, also known as death by neurologic criteria (BD/DNC), was developed by a panel of 20 experts from different specialties, institutions, and medical societies.

As with previous guidelines, the updated version stipulates that brain death should be declared when a patient with a known cause of catastrophic brain injury has permanent loss of function of the brain, including the brain stem, which results in coma, brain stem areflexia, and apnea in the setting of an adequate stimulus.

But the updated version also clarifies questions on neurological examinations and apnea testing and offers new guidance on pre-evaluation targets for blood pressure and body temperature and evaluating brain death in patients who are pregnant, are on extracorporeal membrane oxygenation, or have an injury to the base of the brain.

Also, for the first time, the guidance clarifies that clinicians don’t need to obtain consent before performing a brain death evaluation, unless institutional policy, state laws, or regulations stipulate otherwise.

“The 2023 guidelines will be considered the standard of care in the U.S.,” lead author David M. Greer, MD, chair and chief of neurology, Boston University, and chief of neurology, Boston Medical Center, said in an interview. “Each hospital in the U.S. is responsible for its own policy for BD/DNC determination, and our hope is that they will quickly revise their policies in accordance with this new national standard.”

The guidelines, which are accompanied by a three-page checklist and a free digital app, were published online in Neurology.
 

Four years in the making

Work on the 85 recommendations in the new report began more than 4 years ago as a collaborative effort by the American Academy of Neurology, the American Academy of Pediatrics, the Child Neurology Society, and the Society of Critical Care Medicine.

A lack of high-quality evidence on brain death determination led panelists to devise an evidence-informed formal consensus process to develop the guidelines, which involved three rounds of anonymous voting on each recommendation and the rationales behind them.

The strength of each recommendation was based on the level of consensus reached through voting, with Level A denoting a recommendation that “must” be followed, Level B one that “should” be followed, and Level C one that “may” be followed.

The majority of recommendations received an A or B rating. Only one recommendation, about whether a second clinical exam is needed in adults, garnered a C rating.

In children, the guidelines recommend that clinicians must perform two clinical examinations and two apnea tests 12 hours apart. In adults, only one exam is required. Both of those recommendations were rated Level A. A recommendation for a second exam in adults received the single Level C rating.
 

A uniform set of guidelines?

The new guidelines replace adult practice guidance published by AAN in 2010 and guideline for infants and children released in 2011 by AAP, CNS, and SCCM, and for the first time combine brain death guidelines for adult and pediatric patients into one document.

“It is important for clinicians to review the new guideline carefully and ensure their hospital brain death guidelines are updated to be consistent with the new guideline in order to prevent inaccurate determinations of death,” guidelines coauthor Ariane Lewis, MD, NYU Langone Health, New York, said in an interview.

The 1981 Uniform Determination of Death Act (UDDA) is the legal foundation for the declaration of BD/DNC in the United States, but it only stipulates that brain death determination must be made in accordance with accepted medical standards.

There is no single national standard, and states and hospitals are free to adopt their own, which many have done. One goal of the new guidelines was to create a uniform set of guidelines that all institutions follow.

“This is a step toward having a set of guidelines that are accepted by most of the societies and clinical specialties involved in this sort of diagnosis,” that could lead to a national-level policy, Fernando Goldenberg, MD, professor of neurology and director of neuroscience critical care, University of Chicago Medicine, said in an interview.

Dr. Goldenberg was not part of the panel that developed the updated guidelines, but was a coauthor of a consensus statement from the World Brain Death Project in 2020.

Developing a singular global guideline for brain death determination is unlikely, Dr. Goldenberg said. Policies vary widely across the world, and some countries don’t even recognize brain death.

“But this attempts to unify things at the U.S. level, which is very important,” he said.
 

Permanent vs. irreversible

Dr. Goldenberg said that combining adult and pediatric guidelines into one document will be very helpful for clinicians like him who treat patients from age 16 years and up.

The expanded guidance on apnea testing, recommendations on specific ancillary tests to use or avoid, and inclusion of language stipulating that prior consent is not needed to perform a brain death evaluation are also useful.

He also noted that the section on credentialing and training of clinicians who perform BD/DNC evaluations recognizes advanced practice providers, the first time he recalls seeing these professionals included in brain death guidelines.

However, the panel’s decision to use the term “permanent” to describe loss of brain function instead of “irreversible” gave Dr. Goldenberg pause.

The UDDA provides that an individual is declared legally dead when “circulatory and respiratory functions irreversibly stop; or all functions of the entire brain, including the brain stem, irreversibly stop.”

Earlier in October, the American College of Physicians released a position paper on cardiorespiratory death determination that called for a revision of the UDDA language.

The ACP suggested that “irreversibly” be replaced with “permanently” with regard to the cessation of circulatory and respiratory functions, but that “irreversible” be kept in the description of brain death.

“Permanent means that there is damage that is potentially reversible and irreversible means that the damage is so profound, it cannot be reversed even if an attempt to do so is performed,” Dr. Goldenberg said.

Even though the World Brain Death Project, on which he worked, also used “permanent” to describe brain function loss, Dr. Goldenberg said he aligns with ACP’s position.

“The understanding of brain death is that the damage is so profound, it is irreversible, even if you were to try,” he said. “Therefore, I think that the most appropriate term for brain death should be irreversible as opposed to permanent.”

The report was funded by the American Academy of Neurology. Dr. Greer has received travel funding from Boston University; serves as editor-in-chief for Seminars in Neurology; receives publishing royalties for 50 Studies Every Neurologist Should Know and Successful Leadership in Academic Medicine; has received honoraria from AAN; has received research funding from Becton, Dickinson, and Company; and has served as expert witness in legal proceedings. Dr. Lewis has received honoraria from AAN and Neurodiem, serves as Neurology deputy editor of disputes and debates, and serves as deputy editor of seminars in Neurology. Dr. Goldenberg reported no relevant financial relationships.

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

The American Heart Association has released a focused update on managing patients with cardiac arrest or life-threatening toxicity due to poisoning.

The update reflects treatment advances and new knowledge, including the use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) for patients whose condition is refractory to poison antidotes and other therapies.

The new guidelines are designed primarily for North American health care professionals who treat adults and children who are critically ill because of poisoning, including intentional and unintentional drug overdose, chemical exposure, and drug-drug interactions, the authors note.

Published online in Circulation, the update was endorsed by the American Academy of Pediatrics.
 

‘Nearly miraculous’

“It’s been 13 years since the poisoning treatment guidelines had a comprehensive update,” lead author Eric J. Lavonas, MD, professor of emergency medicine at Denver Health and the Rocky Mountain Poison and Drug Center, Colo., told this news organization. “In that time, we’ve learned a lot about how to best use antidotes and other treatments to save the most critically poisoned patients.”

Highlighting a few key points from the update, he said, “For those rare situations when antidotes aren’t enough, the new guidelines include the use of heart-lung machines (VA-ECMO) for patients with beta-blocker, calcium channel blocker, or sodium channel blocker poisoning causing cardiogenic shock.”

Furthermore, he said, “High-dose insulin treatment for patients with beta-blocker and calcium channel blocker poisoning [also recommended in the update] has really become mainstream. The doses are up to 10 times higher than the amount used to treat diabetic emergencies.

“Some excellent science has shown that giving IV lipid emulsion can save the life of someone with an accidental overdose of local anesthetic medications, particularly bupivacaine,” he added. “The result is sometimes nearly miraculous.

“But when this treatment is extended to poisoning from other medications, it often doesn’t work as well, and in some situations may make things worse,” he said. “The issue may be that giving lipids increases absorption of drug from the stomach and intestines, which can be dangerous when the patient took an overdose of pills.”
 

Low level of evidence

The guidelines were compiled by the Critical Poisoning Writing Group, which includes experts from emergency medicine, pediatrics, medical toxicology, pharmacology, critical care, emergency medical services, education, research, and nursing. Group members were appointed by the AHA Emergency Cardiovascular Care Science Subcommittee and were approved by the AHA Manuscript Oversight Committee.

First and foremost, the group recommends timely consultation with a medical toxicologist, a clinical toxicologist, or a regional poison center to facilitate rapid, effective therapy, because treatment of cardiac arrest and toxicity from poisoning often requires treatments that most clinicians don’t use frequently.

Other key points include the following:

• Naloxone administration may reverse respiratory arrest due to opioid overdose, preventing progression to cardiac arrest.
• Give high-dose insulin therapy early in the treatment of patients with beta-blocker and calcium channel blocker poisoning, Dr. Lavonas noted.
• Standard advanced life support plus sodium bicarbonate is appropriate for life-threatening dysrhythmias caused by cocaine or other sodium channel blockers.
• If cyanide poisoning is suspected, clinicians should not wait for confirmatory testing; treatment should begin immediately with hydroxocobalamin (preferred) or sodium nitrite plus sodium thiosulfate.
• Digoxin-specific immune antibody fragments can reverse life-threatening dysrhythmias from digoxin poisoning.
• Use of 20% intravenous lipid emulsion can be efficacious in the resuscitation of life-threatening local anesthetic toxicity, especially from bupivacaine, Dr. Lavonas indicated.
• Sedation is recommended for patients with severe agitation from sympathomimetic poisoning to manage hyperthermia and acidosis, prevent rhabdomyolysis and injury, and allow evaluation for other life-threatening conditions.
• Although flumazenil reverses central nervous system and respiratory depression from benzodiazepine poisoning, risks and contraindications, provided in the guidelines, limit its use.
• VA-ECMO can be lifesaving for patients with cardiogenic shock or dysrhythmias that are refractory to other treatments.

“Unfortunately, despite improvements in the design and funding support for resuscitation research, the overall certainty of the evidence base for resuscitation science and management of critical poisoning is low,” the group acknowledges.

Of the 73 guideline recommendations, only 2 are supported by level A evidence; 3 are supported by level B-randomized evidence, 12 by level B-nonrandomized evidence, and the rest by level C evidence.

“Accordingly, the strength of recommendations is weaker than optimal,” they write. “Clinical trials in resuscitation and the management of critical poisoning are sorely needed.”
 

‘Don’t go it alone!’

“Most critical poisonings are pretty uncommon, and each patient is different,” Dr. Lavonas said. “Even in the emergency department or ICU, most physicians will treat a patient who is critically ill with any given poison less than once a year. The antidotes and medication doses needed to effectively treat these patients are often very different than everyday medical practice.

“Don’t try to go it alone!” he urges. “Poisoning cases are complex, and the treatments work best when they are implemented quickly and assertively. A toxicologist can help sort through complex situations and get effective treatment started without delay.”

Every certified poison center has a medical toxicologist or clinical toxicologist on call 24/7 to give advice to physicians and hospitals about patients who are critically ill after being poisoned, he added. “Everyone in the U.S. has access to a poison center by calling one number: 1-800-222-1222.”

Dr. Lavonas has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

The American Heart Association has released a focused update on managing patients with cardiac arrest or life-threatening toxicity due to poisoning.

The update reflects treatment advances and new knowledge, including the use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) for patients whose condition is refractory to poison antidotes and other therapies.

The new guidelines are designed primarily for North American health care professionals who treat adults and children who are critically ill because of poisoning, including intentional and unintentional drug overdose, chemical exposure, and drug-drug interactions, the authors note.

Published online in Circulation, the update was endorsed by the American Academy of Pediatrics.
 

‘Nearly miraculous’

“It’s been 13 years since the poisoning treatment guidelines had a comprehensive update,” lead author Eric J. Lavonas, MD, professor of emergency medicine at Denver Health and the Rocky Mountain Poison and Drug Center, Colo., told this news organization. “In that time, we’ve learned a lot about how to best use antidotes and other treatments to save the most critically poisoned patients.”

Highlighting a few key points from the update, he said, “For those rare situations when antidotes aren’t enough, the new guidelines include the use of heart-lung machines (VA-ECMO) for patients with beta-blocker, calcium channel blocker, or sodium channel blocker poisoning causing cardiogenic shock.”

Furthermore, he said, “High-dose insulin treatment for patients with beta-blocker and calcium channel blocker poisoning [also recommended in the update] has really become mainstream. The doses are up to 10 times higher than the amount used to treat diabetic emergencies.

“Some excellent science has shown that giving IV lipid emulsion can save the life of someone with an accidental overdose of local anesthetic medications, particularly bupivacaine,” he added. “The result is sometimes nearly miraculous.

“But when this treatment is extended to poisoning from other medications, it often doesn’t work as well, and in some situations may make things worse,” he said. “The issue may be that giving lipids increases absorption of drug from the stomach and intestines, which can be dangerous when the patient took an overdose of pills.”
 

Low level of evidence

The guidelines were compiled by the Critical Poisoning Writing Group, which includes experts from emergency medicine, pediatrics, medical toxicology, pharmacology, critical care, emergency medical services, education, research, and nursing. Group members were appointed by the AHA Emergency Cardiovascular Care Science Subcommittee and were approved by the AHA Manuscript Oversight Committee.

First and foremost, the group recommends timely consultation with a medical toxicologist, a clinical toxicologist, or a regional poison center to facilitate rapid, effective therapy, because treatment of cardiac arrest and toxicity from poisoning often requires treatments that most clinicians don’t use frequently.

Other key points include the following:

• Naloxone administration may reverse respiratory arrest due to opioid overdose, preventing progression to cardiac arrest.
• Give high-dose insulin therapy early in the treatment of patients with beta-blocker and calcium channel blocker poisoning, Dr. Lavonas noted.
• Standard advanced life support plus sodium bicarbonate is appropriate for life-threatening dysrhythmias caused by cocaine or other sodium channel blockers.
• If cyanide poisoning is suspected, clinicians should not wait for confirmatory testing; treatment should begin immediately with hydroxocobalamin (preferred) or sodium nitrite plus sodium thiosulfate.
• Digoxin-specific immune antibody fragments can reverse life-threatening dysrhythmias from digoxin poisoning.
• Use of 20% intravenous lipid emulsion can be efficacious in the resuscitation of life-threatening local anesthetic toxicity, especially from bupivacaine, Dr. Lavonas indicated.
• Sedation is recommended for patients with severe agitation from sympathomimetic poisoning to manage hyperthermia and acidosis, prevent rhabdomyolysis and injury, and allow evaluation for other life-threatening conditions.
• Although flumazenil reverses central nervous system and respiratory depression from benzodiazepine poisoning, risks and contraindications, provided in the guidelines, limit its use.
• VA-ECMO can be lifesaving for patients with cardiogenic shock or dysrhythmias that are refractory to other treatments.

“Unfortunately, despite improvements in the design and funding support for resuscitation research, the overall certainty of the evidence base for resuscitation science and management of critical poisoning is low,” the group acknowledges.

Of the 73 guideline recommendations, only 2 are supported by level A evidence; 3 are supported by level B-randomized evidence, 12 by level B-nonrandomized evidence, and the rest by level C evidence.

“Accordingly, the strength of recommendations is weaker than optimal,” they write. “Clinical trials in resuscitation and the management of critical poisoning are sorely needed.”
 

‘Don’t go it alone!’

“Most critical poisonings are pretty uncommon, and each patient is different,” Dr. Lavonas said. “Even in the emergency department or ICU, most physicians will treat a patient who is critically ill with any given poison less than once a year. The antidotes and medication doses needed to effectively treat these patients are often very different than everyday medical practice.

“Don’t try to go it alone!” he urges. “Poisoning cases are complex, and the treatments work best when they are implemented quickly and assertively. A toxicologist can help sort through complex situations and get effective treatment started without delay.”

Every certified poison center has a medical toxicologist or clinical toxicologist on call 24/7 to give advice to physicians and hospitals about patients who are critically ill after being poisoned, he added. “Everyone in the U.S. has access to a poison center by calling one number: 1-800-222-1222.”

Dr. Lavonas has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

The American Heart Association has released a focused update on managing patients with cardiac arrest or life-threatening toxicity due to poisoning.

The update reflects treatment advances and new knowledge, including the use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) for patients whose condition is refractory to poison antidotes and other therapies.

The new guidelines are designed primarily for North American health care professionals who treat adults and children who are critically ill because of poisoning, including intentional and unintentional drug overdose, chemical exposure, and drug-drug interactions, the authors note.

Published online in Circulation, the update was endorsed by the American Academy of Pediatrics.
 

‘Nearly miraculous’

“It’s been 13 years since the poisoning treatment guidelines had a comprehensive update,” lead author Eric J. Lavonas, MD, professor of emergency medicine at Denver Health and the Rocky Mountain Poison and Drug Center, Colo., told this news organization. “In that time, we’ve learned a lot about how to best use antidotes and other treatments to save the most critically poisoned patients.”

Highlighting a few key points from the update, he said, “For those rare situations when antidotes aren’t enough, the new guidelines include the use of heart-lung machines (VA-ECMO) for patients with beta-blocker, calcium channel blocker, or sodium channel blocker poisoning causing cardiogenic shock.”

Furthermore, he said, “High-dose insulin treatment for patients with beta-blocker and calcium channel blocker poisoning [also recommended in the update] has really become mainstream. The doses are up to 10 times higher than the amount used to treat diabetic emergencies.

“Some excellent science has shown that giving IV lipid emulsion can save the life of someone with an accidental overdose of local anesthetic medications, particularly bupivacaine,” he added. “The result is sometimes nearly miraculous.

“But when this treatment is extended to poisoning from other medications, it often doesn’t work as well, and in some situations may make things worse,” he said. “The issue may be that giving lipids increases absorption of drug from the stomach and intestines, which can be dangerous when the patient took an overdose of pills.”
 

Low level of evidence

The guidelines were compiled by the Critical Poisoning Writing Group, which includes experts from emergency medicine, pediatrics, medical toxicology, pharmacology, critical care, emergency medical services, education, research, and nursing. Group members were appointed by the AHA Emergency Cardiovascular Care Science Subcommittee and were approved by the AHA Manuscript Oversight Committee.

First and foremost, the group recommends timely consultation with a medical toxicologist, a clinical toxicologist, or a regional poison center to facilitate rapid, effective therapy, because treatment of cardiac arrest and toxicity from poisoning often requires treatments that most clinicians don’t use frequently.

Other key points include the following:

• Naloxone administration may reverse respiratory arrest due to opioid overdose, preventing progression to cardiac arrest.
• Give high-dose insulin therapy early in the treatment of patients with beta-blocker and calcium channel blocker poisoning, Dr. Lavonas noted.
• Standard advanced life support plus sodium bicarbonate is appropriate for life-threatening dysrhythmias caused by cocaine or other sodium channel blockers.
• If cyanide poisoning is suspected, clinicians should not wait for confirmatory testing; treatment should begin immediately with hydroxocobalamin (preferred) or sodium nitrite plus sodium thiosulfate.
• Digoxin-specific immune antibody fragments can reverse life-threatening dysrhythmias from digoxin poisoning.
• Use of 20% intravenous lipid emulsion can be efficacious in the resuscitation of life-threatening local anesthetic toxicity, especially from bupivacaine, Dr. Lavonas indicated.
• Sedation is recommended for patients with severe agitation from sympathomimetic poisoning to manage hyperthermia and acidosis, prevent rhabdomyolysis and injury, and allow evaluation for other life-threatening conditions.
• Although flumazenil reverses central nervous system and respiratory depression from benzodiazepine poisoning, risks and contraindications, provided in the guidelines, limit its use.
• VA-ECMO can be lifesaving for patients with cardiogenic shock or dysrhythmias that are refractory to other treatments.

“Unfortunately, despite improvements in the design and funding support for resuscitation research, the overall certainty of the evidence base for resuscitation science and management of critical poisoning is low,” the group acknowledges.

Of the 73 guideline recommendations, only 2 are supported by level A evidence; 3 are supported by level B-randomized evidence, 12 by level B-nonrandomized evidence, and the rest by level C evidence.

“Accordingly, the strength of recommendations is weaker than optimal,” they write. “Clinical trials in resuscitation and the management of critical poisoning are sorely needed.”
 

‘Don’t go it alone!’

“Most critical poisonings are pretty uncommon, and each patient is different,” Dr. Lavonas said. “Even in the emergency department or ICU, most physicians will treat a patient who is critically ill with any given poison less than once a year. The antidotes and medication doses needed to effectively treat these patients are often very different than everyday medical practice.

“Don’t try to go it alone!” he urges. “Poisoning cases are complex, and the treatments work best when they are implemented quickly and assertively. A toxicologist can help sort through complex situations and get effective treatment started without delay.”

Every certified poison center has a medical toxicologist or clinical toxicologist on call 24/7 to give advice to physicians and hospitals about patients who are critically ill after being poisoned, he added. “Everyone in the U.S. has access to a poison center by calling one number: 1-800-222-1222.”

Dr. Lavonas has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

With ever-expanding treatment options for the ablation of benign thyroid nodules, the American Thyroid Association has issued an expert consensus statement that addresses the safe implementation and utilization of the techniques.

“There are no documents to date in the United States focusing primarily on the safe adoption and implementation of ablation techniques, including learning curve considerations and necessary pre-procedural skillsets,” reports the ATA task force in the consensus statement, which was published in Thyroid.

“Although these emerging technologies hold great promise, they are not without risk and require development of a unique skill set and environment for optimal, safe performance and consistent outcomes,” task force co-author Catherine F. Sinclair, MD, an associate professor at the Icahn School of Medicine at Mount Sinai, New York, said in an interview.

Chemical ablation has long been utilized as a nonsurgical option for benign thyroid nodule ablation. However, the current array of treatment options has expanded with thermal ablation. Techniques such as radiofrequency ablation (RFA), laser ablation, microwave ablation, and high-intensity focused ultrasound have gained favor as minimally invasive alternatives to surgery.

Much has been published on indications and outcomes with the use of the techniques. The multidisciplinary global task force was convened to address key issues regarding safety and utilization. The report is directed toward specialists, including surgeons, endocrinologists, and interventional radiologists.

The recommendations cover three broad categories: safety considerations spanning preprocedural to postprocedural periods; necessary skill sets for optimal, safe performance with the approaches; and the expectations for success in the context of risks and benefits.
 

Ablation methods can depend on nodule type

Among key issues addressed are which ablation methods are most appropriate for which types of nodules. Recommendations include chemical ablation, typically involving the injection of dehydrated ethanol in a target nodule. In solid nodules, diffusion with chemical ablation can be unpredictable, which makes it more appropriate for cystic nodules.

Thermal ablation is considered best suited for patients with compressive and/or cosmetic complaints that clearly involve a single or dominant nodule, as well as for autonomously functioning thyroid nodules that cause subclinical or overt hyperthyroidism.

While ethanol ablation is recommended as a first-line treatment for benign cystic thyroid nodules, its efficacy decreases when there is an increase of more than 20% of the solid component. In such cases, RFA or a combination of ethanol ablation and RFA may be considered, the task force recommends.
 

Patient counseling – managing expectations

Another key consideration in treatment with thyroid nodule ablation is managing patients’ expectations.

Patients should be advised of benefits, such as the avoidance of surgery and general anesthesia and less recovery time. Risks can include thermal or chemical injury to the recurrent laryngeal nerve and other vital structures. The task force underscores discussion of alternative options with patients.

Alternative management options to ablation, including observation, radioactive iodine for functioning nodules, and surgery should also be discussed, and “their relative advantages and disadvantages should be presented without bias such that the patient can make an informed, individual treatment decision,” the task force recommends.

Patients should be informed that, in contrast to surgical management, the benefits of ablation are not immediate; rather, they accrue over the course of months. Reduction in nodule size within the first month is often limited.

Pain, soreness, and some swelling of the nodule and surrounding tissues are common in the first week. These symptoms usually peak in the first 3-5 days after the procedure. Importantly, patients rarely require opioid medications, and their use should be avoided, the task force recommends.

Patients should also be informed about the possibilities of nodule regrowth following ablation and the possible need for more than one ablation procedure.

“Although regrowth definitions in the literature vary, risk of regrowth after thermal ablation is 5%-40% and increases the larger the baseline nodule volume,” the task force notes.

Of note, most studies on ablation to date have shown that thermal ablation complication rates are low. Twelve months post procedure, volume reductions are typically greater than 50%.
 

Follow-up

For long-term monitoring following ablation, follow-up neck ultrasound is typically recommended at 1-3 months and at 6 and 12 months post ablation to assess volume reduction, nodule appearance, nodule vascularity, and areas at risk for regrowth, the authors note.

Prolonged serial biochemical evaluation of thyroid function is only recommended in cases of hyperfunctioning thyroid nodules.

Key considerations for additional ablative sessions for nodules greater than 20-30 mL in volume should include a failure to achieve adequate reduction in volume, nodule regrowth in previously untreated peripheral areas, and/or persistent or new compressive symptoms.
 

Learning curve

Dr. Sinclair underscored that successful thyroid nodule ablation requires skill – and experience.

“Probably the greatest concern shared by the writing group on this statement was the potential for clinicians to start ablation practices without having an appropriate prior skill set,” she said.

“Ablation is an advanced, ultrasound-guided procedure, and clinicians need to be experienced in performing neck ultrasounds and biopsies,” she added. “To consider performing ablations without this skill set is both unrealistic and dangerous.”

RFA, currently the most commonly used thermal ablation method for benign thyroid nodule ablation in the U.S., “has a good safety profile but can have a steep learning curve initially,” she said.

Among the most important recommendations is that for their first 20-60 ablation procedures, clinicians should consider limiting treatment to small- to medium-sized benign nodules rather than large-volume disease, Dr. Sinclair added.

“In addition, prior to starting thyroid ablation practices, clinicians should be proficient in ultrasound imaging and fine-needle biopsies and can gain valuable experience by practicing on phantoms and having expert proctoring for the first few cases,” she said.

For initial ablative cases, the task force recommends that clinicians select moderate-size (< 20-30 mL), nonvascular nodules with favorable characteristics and location. The final volume reduction should be based not only on baseline nodule characteristics, such as volume and vascularity, but also on the practitioner’s skill.

Clinicians furthermore should be board certified or eligible in an appropriate medical specialty, have extensive background knowledge, and “should have clinical experience in the clinical diagnosis and treatment of thyroid nodules; neck imaging anatomy; thyroid ultrasound imaging and fine needle aspiration biopsy procedures; and ultrasound risk stratification for benign and malignant thyroid tumors,” the group recommends.

Importantly, the statement is designed to reflect a consensus opinion of the panel of experts but is not meant to serve as a formal guideline or a standard of care for the clinical practice of thermal ablation, Dr. Sinclair added.

“It is not the intent of the statement to replace individual decision-making, the wishes of the patient or family, or clinical judgment.”

The authors’ disclosures are detailed in the published report.

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

With ever-expanding treatment options for the ablation of benign thyroid nodules, the American Thyroid Association has issued an expert consensus statement that addresses the safe implementation and utilization of the techniques.

“There are no documents to date in the United States focusing primarily on the safe adoption and implementation of ablation techniques, including learning curve considerations and necessary pre-procedural skillsets,” reports the ATA task force in the consensus statement, which was published in Thyroid.

“Although these emerging technologies hold great promise, they are not without risk and require development of a unique skill set and environment for optimal, safe performance and consistent outcomes,” task force co-author Catherine F. Sinclair, MD, an associate professor at the Icahn School of Medicine at Mount Sinai, New York, said in an interview.

Chemical ablation has long been utilized as a nonsurgical option for benign thyroid nodule ablation. However, the current array of treatment options has expanded with thermal ablation. Techniques such as radiofrequency ablation (RFA), laser ablation, microwave ablation, and high-intensity focused ultrasound have gained favor as minimally invasive alternatives to surgery.

Much has been published on indications and outcomes with the use of the techniques. The multidisciplinary global task force was convened to address key issues regarding safety and utilization. The report is directed toward specialists, including surgeons, endocrinologists, and interventional radiologists.

The recommendations cover three broad categories: safety considerations spanning preprocedural to postprocedural periods; necessary skill sets for optimal, safe performance with the approaches; and the expectations for success in the context of risks and benefits.
 

Ablation methods can depend on nodule type

Among key issues addressed are which ablation methods are most appropriate for which types of nodules. Recommendations include chemical ablation, typically involving the injection of dehydrated ethanol in a target nodule. In solid nodules, diffusion with chemical ablation can be unpredictable, which makes it more appropriate for cystic nodules.

Thermal ablation is considered best suited for patients with compressive and/or cosmetic complaints that clearly involve a single or dominant nodule, as well as for autonomously functioning thyroid nodules that cause subclinical or overt hyperthyroidism.

While ethanol ablation is recommended as a first-line treatment for benign cystic thyroid nodules, its efficacy decreases when there is an increase of more than 20% of the solid component. In such cases, RFA or a combination of ethanol ablation and RFA may be considered, the task force recommends.
 

Patient counseling – managing expectations

Another key consideration in treatment with thyroid nodule ablation is managing patients’ expectations.

Patients should be advised of benefits, such as the avoidance of surgery and general anesthesia and less recovery time. Risks can include thermal or chemical injury to the recurrent laryngeal nerve and other vital structures. The task force underscores discussion of alternative options with patients.

Alternative management options to ablation, including observation, radioactive iodine for functioning nodules, and surgery should also be discussed, and “their relative advantages and disadvantages should be presented without bias such that the patient can make an informed, individual treatment decision,” the task force recommends.

Patients should be informed that, in contrast to surgical management, the benefits of ablation are not immediate; rather, they accrue over the course of months. Reduction in nodule size within the first month is often limited.

Pain, soreness, and some swelling of the nodule and surrounding tissues are common in the first week. These symptoms usually peak in the first 3-5 days after the procedure. Importantly, patients rarely require opioid medications, and their use should be avoided, the task force recommends.

Patients should also be informed about the possibilities of nodule regrowth following ablation and the possible need for more than one ablation procedure.

“Although regrowth definitions in the literature vary, risk of regrowth after thermal ablation is 5%-40% and increases the larger the baseline nodule volume,” the task force notes.

Of note, most studies on ablation to date have shown that thermal ablation complication rates are low. Twelve months post procedure, volume reductions are typically greater than 50%.
 

Follow-up

For long-term monitoring following ablation, follow-up neck ultrasound is typically recommended at 1-3 months and at 6 and 12 months post ablation to assess volume reduction, nodule appearance, nodule vascularity, and areas at risk for regrowth, the authors note.

Prolonged serial biochemical evaluation of thyroid function is only recommended in cases of hyperfunctioning thyroid nodules.

Key considerations for additional ablative sessions for nodules greater than 20-30 mL in volume should include a failure to achieve adequate reduction in volume, nodule regrowth in previously untreated peripheral areas, and/or persistent or new compressive symptoms.
 

Learning curve

Dr. Sinclair underscored that successful thyroid nodule ablation requires skill – and experience.

“Probably the greatest concern shared by the writing group on this statement was the potential for clinicians to start ablation practices without having an appropriate prior skill set,” she said.

“Ablation is an advanced, ultrasound-guided procedure, and clinicians need to be experienced in performing neck ultrasounds and biopsies,” she added. “To consider performing ablations without this skill set is both unrealistic and dangerous.”

RFA, currently the most commonly used thermal ablation method for benign thyroid nodule ablation in the U.S., “has a good safety profile but can have a steep learning curve initially,” she said.

Among the most important recommendations is that for their first 20-60 ablation procedures, clinicians should consider limiting treatment to small- to medium-sized benign nodules rather than large-volume disease, Dr. Sinclair added.

“In addition, prior to starting thyroid ablation practices, clinicians should be proficient in ultrasound imaging and fine-needle biopsies and can gain valuable experience by practicing on phantoms and having expert proctoring for the first few cases,” she said.

For initial ablative cases, the task force recommends that clinicians select moderate-size (< 20-30 mL), nonvascular nodules with favorable characteristics and location. The final volume reduction should be based not only on baseline nodule characteristics, such as volume and vascularity, but also on the practitioner’s skill.

Clinicians furthermore should be board certified or eligible in an appropriate medical specialty, have extensive background knowledge, and “should have clinical experience in the clinical diagnosis and treatment of thyroid nodules; neck imaging anatomy; thyroid ultrasound imaging and fine needle aspiration biopsy procedures; and ultrasound risk stratification for benign and malignant thyroid tumors,” the group recommends.

Importantly, the statement is designed to reflect a consensus opinion of the panel of experts but is not meant to serve as a formal guideline or a standard of care for the clinical practice of thermal ablation, Dr. Sinclair added.

“It is not the intent of the statement to replace individual decision-making, the wishes of the patient or family, or clinical judgment.”

The authors’ disclosures are detailed in the published report.

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

With ever-expanding treatment options for the ablation of benign thyroid nodules, the American Thyroid Association has issued an expert consensus statement that addresses the safe implementation and utilization of the techniques.

“There are no documents to date in the United States focusing primarily on the safe adoption and implementation of ablation techniques, including learning curve considerations and necessary pre-procedural skillsets,” reports the ATA task force in the consensus statement, which was published in Thyroid.

“Although these emerging technologies hold great promise, they are not without risk and require development of a unique skill set and environment for optimal, safe performance and consistent outcomes,” task force co-author Catherine F. Sinclair, MD, an associate professor at the Icahn School of Medicine at Mount Sinai, New York, said in an interview.

Chemical ablation has long been utilized as a nonsurgical option for benign thyroid nodule ablation. However, the current array of treatment options has expanded with thermal ablation. Techniques such as radiofrequency ablation (RFA), laser ablation, microwave ablation, and high-intensity focused ultrasound have gained favor as minimally invasive alternatives to surgery.

Much has been published on indications and outcomes with the use of the techniques. The multidisciplinary global task force was convened to address key issues regarding safety and utilization. The report is directed toward specialists, including surgeons, endocrinologists, and interventional radiologists.

The recommendations cover three broad categories: safety considerations spanning preprocedural to postprocedural periods; necessary skill sets for optimal, safe performance with the approaches; and the expectations for success in the context of risks and benefits.
 

Ablation methods can depend on nodule type

Among key issues addressed are which ablation methods are most appropriate for which types of nodules. Recommendations include chemical ablation, typically involving the injection of dehydrated ethanol in a target nodule. In solid nodules, diffusion with chemical ablation can be unpredictable, which makes it more appropriate for cystic nodules.

Thermal ablation is considered best suited for patients with compressive and/or cosmetic complaints that clearly involve a single or dominant nodule, as well as for autonomously functioning thyroid nodules that cause subclinical or overt hyperthyroidism.

While ethanol ablation is recommended as a first-line treatment for benign cystic thyroid nodules, its efficacy decreases when there is an increase of more than 20% of the solid component. In such cases, RFA or a combination of ethanol ablation and RFA may be considered, the task force recommends.
 

Patient counseling – managing expectations

Another key consideration in treatment with thyroid nodule ablation is managing patients’ expectations.

Patients should be advised of benefits, such as the avoidance of surgery and general anesthesia and less recovery time. Risks can include thermal or chemical injury to the recurrent laryngeal nerve and other vital structures. The task force underscores discussion of alternative options with patients.

Alternative management options to ablation, including observation, radioactive iodine for functioning nodules, and surgery should also be discussed, and “their relative advantages and disadvantages should be presented without bias such that the patient can make an informed, individual treatment decision,” the task force recommends.

Patients should be informed that, in contrast to surgical management, the benefits of ablation are not immediate; rather, they accrue over the course of months. Reduction in nodule size within the first month is often limited.

Pain, soreness, and some swelling of the nodule and surrounding tissues are common in the first week. These symptoms usually peak in the first 3-5 days after the procedure. Importantly, patients rarely require opioid medications, and their use should be avoided, the task force recommends.

Patients should also be informed about the possibilities of nodule regrowth following ablation and the possible need for more than one ablation procedure.

“Although regrowth definitions in the literature vary, risk of regrowth after thermal ablation is 5%-40% and increases the larger the baseline nodule volume,” the task force notes.

Of note, most studies on ablation to date have shown that thermal ablation complication rates are low. Twelve months post procedure, volume reductions are typically greater than 50%.
 

Follow-up

For long-term monitoring following ablation, follow-up neck ultrasound is typically recommended at 1-3 months and at 6 and 12 months post ablation to assess volume reduction, nodule appearance, nodule vascularity, and areas at risk for regrowth, the authors note.

Prolonged serial biochemical evaluation of thyroid function is only recommended in cases of hyperfunctioning thyroid nodules.

Key considerations for additional ablative sessions for nodules greater than 20-30 mL in volume should include a failure to achieve adequate reduction in volume, nodule regrowth in previously untreated peripheral areas, and/or persistent or new compressive symptoms.
 

Learning curve

Dr. Sinclair underscored that successful thyroid nodule ablation requires skill – and experience.

“Probably the greatest concern shared by the writing group on this statement was the potential for clinicians to start ablation practices without having an appropriate prior skill set,” she said.

“Ablation is an advanced, ultrasound-guided procedure, and clinicians need to be experienced in performing neck ultrasounds and biopsies,” she added. “To consider performing ablations without this skill set is both unrealistic and dangerous.”

RFA, currently the most commonly used thermal ablation method for benign thyroid nodule ablation in the U.S., “has a good safety profile but can have a steep learning curve initially,” she said.

Among the most important recommendations is that for their first 20-60 ablation procedures, clinicians should consider limiting treatment to small- to medium-sized benign nodules rather than large-volume disease, Dr. Sinclair added.

“In addition, prior to starting thyroid ablation practices, clinicians should be proficient in ultrasound imaging and fine-needle biopsies and can gain valuable experience by practicing on phantoms and having expert proctoring for the first few cases,” she said.

For initial ablative cases, the task force recommends that clinicians select moderate-size (< 20-30 mL), nonvascular nodules with favorable characteristics and location. The final volume reduction should be based not only on baseline nodule characteristics, such as volume and vascularity, but also on the practitioner’s skill.

Clinicians furthermore should be board certified or eligible in an appropriate medical specialty, have extensive background knowledge, and “should have clinical experience in the clinical diagnosis and treatment of thyroid nodules; neck imaging anatomy; thyroid ultrasound imaging and fine needle aspiration biopsy procedures; and ultrasound risk stratification for benign and malignant thyroid tumors,” the group recommends.

Importantly, the statement is designed to reflect a consensus opinion of the panel of experts but is not meant to serve as a formal guideline or a standard of care for the clinical practice of thermal ablation, Dr. Sinclair added.

“It is not the intent of the statement to replace individual decision-making, the wishes of the patient or family, or clinical judgment.”

The authors’ disclosures are detailed in the published report.

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