Clopidogrel Tops Aspirin Post-PCI, Even in High-Risk Cases

Article Type
Changed

TOPLINE:

The beneficial effect of clopidogrel monotherapy over aspirin monotherapy in patients who underwent percutaneous coronary intervention (PCI) and remained event free for 6-18 months on dual antiplatelet therapy (DAPT) is consistent, regardless of bleeding risk or PCI complexity, according to a post hoc analysis of the HOST-EXAM trial.

METHODOLOGY:

  • The HOST-EXAM Extended study conducted across 37 sites in South Korea included patients who underwent PCI with drug-eluting stents and remained free of clinical events for 6-18 months post-PCI, while receiving DAPT.
  • This post hoc analysis of the HOST-EXAM Extended study compared the effectiveness of long-term daily clopidogrel (75 mg) with that of aspirin monotherapy (100 mg) after PCI, according to bleeding risk and procedural complexity in 3974 patients (mean age, 63 years; 75% men) who were followed for up to 5.9 years.
  • High bleeding risk was reported in 866 patients, and 849 patients underwent complex PCI.
  • Patients were classified into four distinct risk groups: No bleeding risk and noncomplex PCI, no bleeding risk and complex PCI, high bleeding risk and noncomplex PCI, and high bleeding risk and complex PCI.
  • The co-primary endpoints were thrombotic composite events (cardiovascular death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and definite/probable stent thrombosis) and any bleeding event.

TAKEAWAY:

  • Thrombotic composite events (hazard ratio [HR], 2.15; P < .001) and any bleeding event (HR, 3.64; P < .001) were more frequent in patients with a high bleeding risk than in those without.
  • However, there was no difference in the risk for thrombotic composite events or any bleeding event by PCI complexity.
  • The long-term benefits of clopidogrel monotherapy over aspirin monotherapy were seen in all patients, regardless of bleeding risks (P for interaction = .38 for thrombotic composite events and P for interaction = .20 for any bleeding event) or PCI complexity (P for interaction = .12 for thrombotic composite events and P for interaction = .62 for any bleeding event).
  • The greatest risk reduction in thrombotic composite events with clopidogrel monotherapy occurred in patients with a high bleeding risk who underwent complex PCI (HR, 0.46; P = .03).

IN PRACTICE:

“[In this study], no significant interaction was found between treatment arms and risk groups, denoting that the beneficial impact of clopidogrel monotherapy was consistent regardless of HBR [high bleeding risk] or PCI complexity,” the authors wrote.

SOURCE:

This study was led by Jeehoon Kang, MD, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Republic of Korea. It was published online on November 27, 2024, in JAMA Cardiology.

LIMITATIONS:

As this study is a post hoc analysis, the findings should be considered primarily hypothesis generating. This study was conducted exclusively in an East Asian population and may not be generalizable to other ethnic groups. The definitions of high bleeding risk and complex PCI used in this analysis were not prespecified in the study protocol of the HOST-EXAM trial. Certain criteria defining high bleeding risk were not analyzed as they fell under the exclusion criteria of the HOST-EXAM trial or were not recorded in the study case report form.

DISCLOSURES:

This study was supported by grants from the Patient-Centered Clinical Research Coordinating Center and Seoul National University Hospital. One author reported receiving grants and personal fees from various pharmaceutical companies outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

TOPLINE:

The beneficial effect of clopidogrel monotherapy over aspirin monotherapy in patients who underwent percutaneous coronary intervention (PCI) and remained event free for 6-18 months on dual antiplatelet therapy (DAPT) is consistent, regardless of bleeding risk or PCI complexity, according to a post hoc analysis of the HOST-EXAM trial.

METHODOLOGY:

  • The HOST-EXAM Extended study conducted across 37 sites in South Korea included patients who underwent PCI with drug-eluting stents and remained free of clinical events for 6-18 months post-PCI, while receiving DAPT.
  • This post hoc analysis of the HOST-EXAM Extended study compared the effectiveness of long-term daily clopidogrel (75 mg) with that of aspirin monotherapy (100 mg) after PCI, according to bleeding risk and procedural complexity in 3974 patients (mean age, 63 years; 75% men) who were followed for up to 5.9 years.
  • High bleeding risk was reported in 866 patients, and 849 patients underwent complex PCI.
  • Patients were classified into four distinct risk groups: No bleeding risk and noncomplex PCI, no bleeding risk and complex PCI, high bleeding risk and noncomplex PCI, and high bleeding risk and complex PCI.
  • The co-primary endpoints were thrombotic composite events (cardiovascular death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and definite/probable stent thrombosis) and any bleeding event.

TAKEAWAY:

  • Thrombotic composite events (hazard ratio [HR], 2.15; P < .001) and any bleeding event (HR, 3.64; P < .001) were more frequent in patients with a high bleeding risk than in those without.
  • However, there was no difference in the risk for thrombotic composite events or any bleeding event by PCI complexity.
  • The long-term benefits of clopidogrel monotherapy over aspirin monotherapy were seen in all patients, regardless of bleeding risks (P for interaction = .38 for thrombotic composite events and P for interaction = .20 for any bleeding event) or PCI complexity (P for interaction = .12 for thrombotic composite events and P for interaction = .62 for any bleeding event).
  • The greatest risk reduction in thrombotic composite events with clopidogrel monotherapy occurred in patients with a high bleeding risk who underwent complex PCI (HR, 0.46; P = .03).

IN PRACTICE:

“[In this study], no significant interaction was found between treatment arms and risk groups, denoting that the beneficial impact of clopidogrel monotherapy was consistent regardless of HBR [high bleeding risk] or PCI complexity,” the authors wrote.

SOURCE:

This study was led by Jeehoon Kang, MD, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Republic of Korea. It was published online on November 27, 2024, in JAMA Cardiology.

LIMITATIONS:

As this study is a post hoc analysis, the findings should be considered primarily hypothesis generating. This study was conducted exclusively in an East Asian population and may not be generalizable to other ethnic groups. The definitions of high bleeding risk and complex PCI used in this analysis were not prespecified in the study protocol of the HOST-EXAM trial. Certain criteria defining high bleeding risk were not analyzed as they fell under the exclusion criteria of the HOST-EXAM trial or were not recorded in the study case report form.

DISCLOSURES:

This study was supported by grants from the Patient-Centered Clinical Research Coordinating Center and Seoul National University Hospital. One author reported receiving grants and personal fees from various pharmaceutical companies outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The beneficial effect of clopidogrel monotherapy over aspirin monotherapy in patients who underwent percutaneous coronary intervention (PCI) and remained event free for 6-18 months on dual antiplatelet therapy (DAPT) is consistent, regardless of bleeding risk or PCI complexity, according to a post hoc analysis of the HOST-EXAM trial.

METHODOLOGY:

  • The HOST-EXAM Extended study conducted across 37 sites in South Korea included patients who underwent PCI with drug-eluting stents and remained free of clinical events for 6-18 months post-PCI, while receiving DAPT.
  • This post hoc analysis of the HOST-EXAM Extended study compared the effectiveness of long-term daily clopidogrel (75 mg) with that of aspirin monotherapy (100 mg) after PCI, according to bleeding risk and procedural complexity in 3974 patients (mean age, 63 years; 75% men) who were followed for up to 5.9 years.
  • High bleeding risk was reported in 866 patients, and 849 patients underwent complex PCI.
  • Patients were classified into four distinct risk groups: No bleeding risk and noncomplex PCI, no bleeding risk and complex PCI, high bleeding risk and noncomplex PCI, and high bleeding risk and complex PCI.
  • The co-primary endpoints were thrombotic composite events (cardiovascular death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and definite/probable stent thrombosis) and any bleeding event.

TAKEAWAY:

  • Thrombotic composite events (hazard ratio [HR], 2.15; P < .001) and any bleeding event (HR, 3.64; P < .001) were more frequent in patients with a high bleeding risk than in those without.
  • However, there was no difference in the risk for thrombotic composite events or any bleeding event by PCI complexity.
  • The long-term benefits of clopidogrel monotherapy over aspirin monotherapy were seen in all patients, regardless of bleeding risks (P for interaction = .38 for thrombotic composite events and P for interaction = .20 for any bleeding event) or PCI complexity (P for interaction = .12 for thrombotic composite events and P for interaction = .62 for any bleeding event).
  • The greatest risk reduction in thrombotic composite events with clopidogrel monotherapy occurred in patients with a high bleeding risk who underwent complex PCI (HR, 0.46; P = .03).

IN PRACTICE:

“[In this study], no significant interaction was found between treatment arms and risk groups, denoting that the beneficial impact of clopidogrel monotherapy was consistent regardless of HBR [high bleeding risk] or PCI complexity,” the authors wrote.

SOURCE:

This study was led by Jeehoon Kang, MD, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Republic of Korea. It was published online on November 27, 2024, in JAMA Cardiology.

LIMITATIONS:

As this study is a post hoc analysis, the findings should be considered primarily hypothesis generating. This study was conducted exclusively in an East Asian population and may not be generalizable to other ethnic groups. The definitions of high bleeding risk and complex PCI used in this analysis were not prespecified in the study protocol of the HOST-EXAM trial. Certain criteria defining high bleeding risk were not analyzed as they fell under the exclusion criteria of the HOST-EXAM trial or were not recorded in the study case report form.

DISCLOSURES:

This study was supported by grants from the Patient-Centered Clinical Research Coordinating Center and Seoul National University Hospital. One author reported receiving grants and personal fees from various pharmaceutical companies outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Un-Gate On Date
Use ProPublica
CFC Schedule Remove Status
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date

High-Volume Burn Resuscitation Increases Neurologic Risk

Article Type
Changed

TOPLINE:

Patients receiving > 200 mL/kg of fluid resuscitation for burn injuries show higher rates of worsening neurologic findings on imaging, with follow-up scans showing deterioration in high-volume recipients compared with low-volume recipients.

METHODOLOGY:

  • Researchers conducted a single-center review of 5176 patients with burn injuries who were admitted to a verified American Burn Association center (2003-2017); 622 of them underwent head CT within 96 hours of admission, and 83 showed intracranial abnormalities.
  • Of 42 patients (mean age, 49.7 years; 80.5% men) who were admitted within 24 hours of burn, 30 patients received < 200 mL/kg and 11 received > 200 mL/kg of total resuscitation fluids, with a median total body surface area (TBSA) of 20.0.
  • The primary outcome assessed was the worsening of neurologic findings on imaging related to the volume of the resuscitation fluid administered; the secondary outcomes were the incidence of new or worsening intracranial abnormalities, including hemorrhage, edema, ischemia, or infarction.

TAKEAWAY:

  • Neurologic findings worsened in 47.6% patients receiving < 200 mL/kg of fluid resuscitation and 85.7% of those receiving > 200 mL/kg (P =.064).
  • Repeat imaging was performed in 21 (70.0%) patients receiving < 200 mL/kg and 7 (63.6%) patients receiving > 200 mL/kg of resuscitation who underwent follow-up imaging.
  • The median TBSA was 16.5 in the < 200 mL/kg group and 53.2 in the > 200 mL/kg group (P <.001).
  • Intracranial abnormalities were found in 31.3% patients with hemorrhage, 18.8% with worsening edema, and 43.8% with ischemia or infarction.

IN PRACTICE:

“Patients who received over 200 mL/kg of resuscitation had an increased progression of intracranial abnormalities when compared with patients receiving less volume resuscitation,” the authors wrote. “Neurologic changes prompting imaging in burn patients may be undetectable, and our study further highlights the need for routine evaluation with neurologic imaging when undergoing large-volume resuscitations.”

SOURCE:

The study was led by Connor L. Kenney, MD, Brooke Army Medical Center, San Antonio, and was published online on November 07, 2024, in the Journal of Surgical Research.

LIMITATIONS:

Study limitations included a small patient sample and unclear guidelines for obtaining head CT scans, making it difficult to distinguish between trauma-related brain changes and disease progression. Additionally, the study lacked data on hypotensive episodes and long-term neurologic outcomes.

DISCLOSURES:

This study did not receive any specific funding. The authors declared no conflicts of interest.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

TOPLINE:

Patients receiving > 200 mL/kg of fluid resuscitation for burn injuries show higher rates of worsening neurologic findings on imaging, with follow-up scans showing deterioration in high-volume recipients compared with low-volume recipients.

METHODOLOGY:

  • Researchers conducted a single-center review of 5176 patients with burn injuries who were admitted to a verified American Burn Association center (2003-2017); 622 of them underwent head CT within 96 hours of admission, and 83 showed intracranial abnormalities.
  • Of 42 patients (mean age, 49.7 years; 80.5% men) who were admitted within 24 hours of burn, 30 patients received < 200 mL/kg and 11 received > 200 mL/kg of total resuscitation fluids, with a median total body surface area (TBSA) of 20.0.
  • The primary outcome assessed was the worsening of neurologic findings on imaging related to the volume of the resuscitation fluid administered; the secondary outcomes were the incidence of new or worsening intracranial abnormalities, including hemorrhage, edema, ischemia, or infarction.

TAKEAWAY:

  • Neurologic findings worsened in 47.6% patients receiving < 200 mL/kg of fluid resuscitation and 85.7% of those receiving > 200 mL/kg (P =.064).
  • Repeat imaging was performed in 21 (70.0%) patients receiving < 200 mL/kg and 7 (63.6%) patients receiving > 200 mL/kg of resuscitation who underwent follow-up imaging.
  • The median TBSA was 16.5 in the < 200 mL/kg group and 53.2 in the > 200 mL/kg group (P <.001).
  • Intracranial abnormalities were found in 31.3% patients with hemorrhage, 18.8% with worsening edema, and 43.8% with ischemia or infarction.

IN PRACTICE:

“Patients who received over 200 mL/kg of resuscitation had an increased progression of intracranial abnormalities when compared with patients receiving less volume resuscitation,” the authors wrote. “Neurologic changes prompting imaging in burn patients may be undetectable, and our study further highlights the need for routine evaluation with neurologic imaging when undergoing large-volume resuscitations.”

SOURCE:

The study was led by Connor L. Kenney, MD, Brooke Army Medical Center, San Antonio, and was published online on November 07, 2024, in the Journal of Surgical Research.

LIMITATIONS:

Study limitations included a small patient sample and unclear guidelines for obtaining head CT scans, making it difficult to distinguish between trauma-related brain changes and disease progression. Additionally, the study lacked data on hypotensive episodes and long-term neurologic outcomes.

DISCLOSURES:

This study did not receive any specific funding. The authors declared no conflicts of interest.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Patients receiving > 200 mL/kg of fluid resuscitation for burn injuries show higher rates of worsening neurologic findings on imaging, with follow-up scans showing deterioration in high-volume recipients compared with low-volume recipients.

METHODOLOGY:

  • Researchers conducted a single-center review of 5176 patients with burn injuries who were admitted to a verified American Burn Association center (2003-2017); 622 of them underwent head CT within 96 hours of admission, and 83 showed intracranial abnormalities.
  • Of 42 patients (mean age, 49.7 years; 80.5% men) who were admitted within 24 hours of burn, 30 patients received < 200 mL/kg and 11 received > 200 mL/kg of total resuscitation fluids, with a median total body surface area (TBSA) of 20.0.
  • The primary outcome assessed was the worsening of neurologic findings on imaging related to the volume of the resuscitation fluid administered; the secondary outcomes were the incidence of new or worsening intracranial abnormalities, including hemorrhage, edema, ischemia, or infarction.

TAKEAWAY:

  • Neurologic findings worsened in 47.6% patients receiving < 200 mL/kg of fluid resuscitation and 85.7% of those receiving > 200 mL/kg (P =.064).
  • Repeat imaging was performed in 21 (70.0%) patients receiving < 200 mL/kg and 7 (63.6%) patients receiving > 200 mL/kg of resuscitation who underwent follow-up imaging.
  • The median TBSA was 16.5 in the < 200 mL/kg group and 53.2 in the > 200 mL/kg group (P <.001).
  • Intracranial abnormalities were found in 31.3% patients with hemorrhage, 18.8% with worsening edema, and 43.8% with ischemia or infarction.

IN PRACTICE:

“Patients who received over 200 mL/kg of resuscitation had an increased progression of intracranial abnormalities when compared with patients receiving less volume resuscitation,” the authors wrote. “Neurologic changes prompting imaging in burn patients may be undetectable, and our study further highlights the need for routine evaluation with neurologic imaging when undergoing large-volume resuscitations.”

SOURCE:

The study was led by Connor L. Kenney, MD, Brooke Army Medical Center, San Antonio, and was published online on November 07, 2024, in the Journal of Surgical Research.

LIMITATIONS:

Study limitations included a small patient sample and unclear guidelines for obtaining head CT scans, making it difficult to distinguish between trauma-related brain changes and disease progression. Additionally, the study lacked data on hypotensive episodes and long-term neurologic outcomes.

DISCLOSURES:

This study did not receive any specific funding. The authors declared no conflicts of interest.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Un-Gate On Date
Use ProPublica
CFC Schedule Remove Status
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date

Australia Registry Study: Melanoma-Related Deaths Increase at 0.8-mm Breslow Thickness

Article Type
Changed

TOPLINE:

The risk for melanoma-related death was higher in individuals with tumors with a Breslow thickness of 0.8-1.0 mm than in individuals with tumors smaller than 0.8 mm, in an Australian study that used registry data.

METHODOLOGY:

  • The study analyzed 144,447 individuals (median age, 56 years, 54% men) diagnosed with thin (T1) primary invasive melanomas (Breslow thickness, ≤ 1.0 mm) between 1982 and 2014 from all eight Australian state and territory population-based cancer registries.
  • The researchers evaluated the associations between Breslow thickness (< 0.8 mm vs 0.8-1.0 mm) and incidences of melanoma-related and nonmelanoma-related deaths.
  • The primary endpoint was time to death attributable to a melanoma-related cause, with death by a nonmelanoma-related cause as a competing event.

TAKEAWAY:

  • The 20-year cumulative incidence of melanoma-related deaths was 6.3% for the whole cohort. The incidence was higher for tumors with a thickness of 0.8-1.0 mm (11%) than for those with a thickness < 0.8 mm (5.6%).
  • The overall 20-year melanoma-specific survival rate was 95.9%, with rates of 94.2% for tumors < 0.8 mm and 87.8% for tumors measuring 0.8-1.0 mm in thickness. Each 0.1-mm increase in Breslow thickness was associated with worse prognosis.
  • A multivariable analysis revealed that a tumor thickness of 0.8-1.0 mm was associated with both a greater absolute risk for melanoma-related deaths (subdistribution hazard ratio, 2.92) and a higher rate of melanoma-related deaths (hazard ratio, 2.98) than a tumor thickness < 0.8 mm.
  • The 20-year incidence of death from nonmelanoma-related causes was 23.4%, but the risk for death from these causes showed no significant association with Breslow thickness categories.

IN PRACTICE:

“The findings of this large-scale population–based analysis suggest the separation of risk for patients with melanomas with a Breslow thickness above and below 0.8 mm,” the authors wrote, adding: “These results suggest that a change of the T1 threshold from 1.0 mm to 0.8 mm should be considered when the AJCC [American Joint Committee on Cancer] staging system is next reviewed.”

SOURCE:

The study was led by Serigne N. Lo, PhD, Melanoma Institute Australia, the University of Sydney. It was published online on December 11, 2024, in JAMA Dermatology.

LIMITATIONS:

The study was registry-based and did not capture details such as tumor characteristics and treatment modalities. Inaccuracies in reporting the cause of death may have led to an underestimation of melanoma-specific mortality risks across all thickness groups and an overestimation of nonmelanoma mortality risks.

DISCLOSURES:

The study received funding support from Melanoma Institute Australia and two grants from the Australian National Health and Medical Research Council (NHMRC). Several authors reported receiving grants or personal fees from or having ties with various sources, including NHMRC.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

TOPLINE:

The risk for melanoma-related death was higher in individuals with tumors with a Breslow thickness of 0.8-1.0 mm than in individuals with tumors smaller than 0.8 mm, in an Australian study that used registry data.

METHODOLOGY:

  • The study analyzed 144,447 individuals (median age, 56 years, 54% men) diagnosed with thin (T1) primary invasive melanomas (Breslow thickness, ≤ 1.0 mm) between 1982 and 2014 from all eight Australian state and territory population-based cancer registries.
  • The researchers evaluated the associations between Breslow thickness (< 0.8 mm vs 0.8-1.0 mm) and incidences of melanoma-related and nonmelanoma-related deaths.
  • The primary endpoint was time to death attributable to a melanoma-related cause, with death by a nonmelanoma-related cause as a competing event.

TAKEAWAY:

  • The 20-year cumulative incidence of melanoma-related deaths was 6.3% for the whole cohort. The incidence was higher for tumors with a thickness of 0.8-1.0 mm (11%) than for those with a thickness < 0.8 mm (5.6%).
  • The overall 20-year melanoma-specific survival rate was 95.9%, with rates of 94.2% for tumors < 0.8 mm and 87.8% for tumors measuring 0.8-1.0 mm in thickness. Each 0.1-mm increase in Breslow thickness was associated with worse prognosis.
  • A multivariable analysis revealed that a tumor thickness of 0.8-1.0 mm was associated with both a greater absolute risk for melanoma-related deaths (subdistribution hazard ratio, 2.92) and a higher rate of melanoma-related deaths (hazard ratio, 2.98) than a tumor thickness < 0.8 mm.
  • The 20-year incidence of death from nonmelanoma-related causes was 23.4%, but the risk for death from these causes showed no significant association with Breslow thickness categories.

IN PRACTICE:

“The findings of this large-scale population–based analysis suggest the separation of risk for patients with melanomas with a Breslow thickness above and below 0.8 mm,” the authors wrote, adding: “These results suggest that a change of the T1 threshold from 1.0 mm to 0.8 mm should be considered when the AJCC [American Joint Committee on Cancer] staging system is next reviewed.”

SOURCE:

The study was led by Serigne N. Lo, PhD, Melanoma Institute Australia, the University of Sydney. It was published online on December 11, 2024, in JAMA Dermatology.

LIMITATIONS:

The study was registry-based and did not capture details such as tumor characteristics and treatment modalities. Inaccuracies in reporting the cause of death may have led to an underestimation of melanoma-specific mortality risks across all thickness groups and an overestimation of nonmelanoma mortality risks.

DISCLOSURES:

The study received funding support from Melanoma Institute Australia and two grants from the Australian National Health and Medical Research Council (NHMRC). Several authors reported receiving grants or personal fees from or having ties with various sources, including NHMRC.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The risk for melanoma-related death was higher in individuals with tumors with a Breslow thickness of 0.8-1.0 mm than in individuals with tumors smaller than 0.8 mm, in an Australian study that used registry data.

METHODOLOGY:

  • The study analyzed 144,447 individuals (median age, 56 years, 54% men) diagnosed with thin (T1) primary invasive melanomas (Breslow thickness, ≤ 1.0 mm) between 1982 and 2014 from all eight Australian state and territory population-based cancer registries.
  • The researchers evaluated the associations between Breslow thickness (< 0.8 mm vs 0.8-1.0 mm) and incidences of melanoma-related and nonmelanoma-related deaths.
  • The primary endpoint was time to death attributable to a melanoma-related cause, with death by a nonmelanoma-related cause as a competing event.

TAKEAWAY:

  • The 20-year cumulative incidence of melanoma-related deaths was 6.3% for the whole cohort. The incidence was higher for tumors with a thickness of 0.8-1.0 mm (11%) than for those with a thickness < 0.8 mm (5.6%).
  • The overall 20-year melanoma-specific survival rate was 95.9%, with rates of 94.2% for tumors < 0.8 mm and 87.8% for tumors measuring 0.8-1.0 mm in thickness. Each 0.1-mm increase in Breslow thickness was associated with worse prognosis.
  • A multivariable analysis revealed that a tumor thickness of 0.8-1.0 mm was associated with both a greater absolute risk for melanoma-related deaths (subdistribution hazard ratio, 2.92) and a higher rate of melanoma-related deaths (hazard ratio, 2.98) than a tumor thickness < 0.8 mm.
  • The 20-year incidence of death from nonmelanoma-related causes was 23.4%, but the risk for death from these causes showed no significant association with Breslow thickness categories.

IN PRACTICE:

“The findings of this large-scale population–based analysis suggest the separation of risk for patients with melanomas with a Breslow thickness above and below 0.8 mm,” the authors wrote, adding: “These results suggest that a change of the T1 threshold from 1.0 mm to 0.8 mm should be considered when the AJCC [American Joint Committee on Cancer] staging system is next reviewed.”

SOURCE:

The study was led by Serigne N. Lo, PhD, Melanoma Institute Australia, the University of Sydney. It was published online on December 11, 2024, in JAMA Dermatology.

LIMITATIONS:

The study was registry-based and did not capture details such as tumor characteristics and treatment modalities. Inaccuracies in reporting the cause of death may have led to an underestimation of melanoma-specific mortality risks across all thickness groups and an overestimation of nonmelanoma mortality risks.

DISCLOSURES:

The study received funding support from Melanoma Institute Australia and two grants from the Australian National Health and Medical Research Council (NHMRC). Several authors reported receiving grants or personal fees from or having ties with various sources, including NHMRC.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Un-Gate On Date
Use ProPublica
CFC Schedule Remove Status
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date

Do GLP-1s Lower VTE Risk in People With Type 2 Diabetes?

Article Type
Changed

Glucagon-like peptide 1 (GLP-1) receptor agonists led to a significant reduction in the risk for venous thromboembolism (VTE) among individuals with type 2 diabetes, compared with dipeptidyl peptidase 4 (DPP-4) inhibitors, a recent analysis indicated.

Overall, GLP-1 agonist use was associated with a 20% reduction in VTE, compared with DPP-4 inhibitor use, in those with type 2 diabetes, and this benefit held regardless of people’s obesity status, said study investigator Cho-Han Chiang, MD, a medical resident at Mount Auburn Hospital, Cambridge, Massachusetts, who presented the findings at the American Society of Hematology (ASH) 2024 Annual Meeting.

The incidence of VTE has increased by 20% over the past 10 years, and obesity is a risk factor for VTE, Chiang explained. A growing body of evidence demonstrated that GLP-1s provide a variety of cardiovascular benefits in people with type 2 diabetes, but data on VTE benefits remain more limited.

In the retrospective study, the researchers combed electronic health records from the TriNetX global database, which includes more than 250 million patients, and identified adults with type 2 diabetes who were taking a GLP-1 agonist or a DPP-4 inhibitor.

After excluding anyone with prior VTE or atrial fibrillation as well as those treated with both drugs or with oral anticoagulants, patients on GLP-1s were matched with those on DPP-4 inhibitors based on predetermined variables, including age, sex, race, body mass index (BMI), hemoglobin A1c, use of other antidiabetic agents, and underlying comorbidities. VTE was a composite of pulmonary embolism and deep vein thrombosis.

The researchers also performed a subgroup analysis that stratified patients by obesity status, defined as a BMI ≥ 30.

Within 1 year of GLP-1 or DPP-4 prescription, VTE occurred at a rate of 6.5 cases/1000 person-years in the GLP-1 group vs 7.9 cases/1000 person years in the DPP-4 inhibitor group (hazard ratio [HR], 0.80; P < .001).

The 20% risk reduction in VTE held across various subgroups of BMI, including among those with obesity, Chiang reported.

Among patients with the highest BMI (≥ 40), VTE occurred at a rate of 7.2 cases/1000 person years in the GLP-1 group vs 9.6 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.74). Among patients with the next highest BMI (30-34.9), VTE occurred at a rate of 4.8 cases/1000 person years in the GLP-1 group vs 7.9 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.60). Among those with the lowest BMI (18.5-24.9), VTE occurred significantly less frequently among those in the GLP-1 group — 4.7 cases/1000 person years vs 7.4 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.61).

The lower risk for VTE associated with GLP-1s also held across the individual components of the composite VTE. Pulmonary embolism occurred at a rate of 3.1 cases/1000 person years in the GLP-1 group vs 3.9 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.78), and deep vein thrombosis occurred in 4.2 cases/1000 person years in the GLP-1 group vs 5.0 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.82).

Interestingly, the GLP-1 and DPP-4 curves started diverging within the first 30 days of the index prescription date, said Chiang.

Session moderator Ghadeer Dawwas, PhD, said in an interview that patients with type 2 diabetes are increasingly using GLP-1 agonists because of the cardiovascular benefits associated with the agents, which include lower risks for stroke and heart failure, but the antithrombotic benefits are still debated.

“The current study indicates that GLP-1 agonists may help lower the risk of VTE in patients with type 2 diabetes, irrespective of their baseline body weight,” said Dawwas, a pharmacoepidemiologist and assistant professor of medicine at Vanderbilt University Medical Center in Nashville, Tennessee. “However, given the current landscape of evidence and the existence of conflicting data on VTE risk, clinicians should proceed with caution and await further studies to validate these findings before making clinical decisions.”

This study was funded by the National Blood Clot Alliance and Conquer Cancer Foundation. Chiang and Dawwas had no disclosures.

A version of this article appeared on Medscape.com.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

Glucagon-like peptide 1 (GLP-1) receptor agonists led to a significant reduction in the risk for venous thromboembolism (VTE) among individuals with type 2 diabetes, compared with dipeptidyl peptidase 4 (DPP-4) inhibitors, a recent analysis indicated.

Overall, GLP-1 agonist use was associated with a 20% reduction in VTE, compared with DPP-4 inhibitor use, in those with type 2 diabetes, and this benefit held regardless of people’s obesity status, said study investigator Cho-Han Chiang, MD, a medical resident at Mount Auburn Hospital, Cambridge, Massachusetts, who presented the findings at the American Society of Hematology (ASH) 2024 Annual Meeting.

The incidence of VTE has increased by 20% over the past 10 years, and obesity is a risk factor for VTE, Chiang explained. A growing body of evidence demonstrated that GLP-1s provide a variety of cardiovascular benefits in people with type 2 diabetes, but data on VTE benefits remain more limited.

In the retrospective study, the researchers combed electronic health records from the TriNetX global database, which includes more than 250 million patients, and identified adults with type 2 diabetes who were taking a GLP-1 agonist or a DPP-4 inhibitor.

After excluding anyone with prior VTE or atrial fibrillation as well as those treated with both drugs or with oral anticoagulants, patients on GLP-1s were matched with those on DPP-4 inhibitors based on predetermined variables, including age, sex, race, body mass index (BMI), hemoglobin A1c, use of other antidiabetic agents, and underlying comorbidities. VTE was a composite of pulmonary embolism and deep vein thrombosis.

The researchers also performed a subgroup analysis that stratified patients by obesity status, defined as a BMI ≥ 30.

Within 1 year of GLP-1 or DPP-4 prescription, VTE occurred at a rate of 6.5 cases/1000 person-years in the GLP-1 group vs 7.9 cases/1000 person years in the DPP-4 inhibitor group (hazard ratio [HR], 0.80; P < .001).

The 20% risk reduction in VTE held across various subgroups of BMI, including among those with obesity, Chiang reported.

Among patients with the highest BMI (≥ 40), VTE occurred at a rate of 7.2 cases/1000 person years in the GLP-1 group vs 9.6 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.74). Among patients with the next highest BMI (30-34.9), VTE occurred at a rate of 4.8 cases/1000 person years in the GLP-1 group vs 7.9 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.60). Among those with the lowest BMI (18.5-24.9), VTE occurred significantly less frequently among those in the GLP-1 group — 4.7 cases/1000 person years vs 7.4 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.61).

The lower risk for VTE associated with GLP-1s also held across the individual components of the composite VTE. Pulmonary embolism occurred at a rate of 3.1 cases/1000 person years in the GLP-1 group vs 3.9 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.78), and deep vein thrombosis occurred in 4.2 cases/1000 person years in the GLP-1 group vs 5.0 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.82).

Interestingly, the GLP-1 and DPP-4 curves started diverging within the first 30 days of the index prescription date, said Chiang.

Session moderator Ghadeer Dawwas, PhD, said in an interview that patients with type 2 diabetes are increasingly using GLP-1 agonists because of the cardiovascular benefits associated with the agents, which include lower risks for stroke and heart failure, but the antithrombotic benefits are still debated.

“The current study indicates that GLP-1 agonists may help lower the risk of VTE in patients with type 2 diabetes, irrespective of their baseline body weight,” said Dawwas, a pharmacoepidemiologist and assistant professor of medicine at Vanderbilt University Medical Center in Nashville, Tennessee. “However, given the current landscape of evidence and the existence of conflicting data on VTE risk, clinicians should proceed with caution and await further studies to validate these findings before making clinical decisions.”

This study was funded by the National Blood Clot Alliance and Conquer Cancer Foundation. Chiang and Dawwas had no disclosures.

A version of this article appeared on Medscape.com.

Glucagon-like peptide 1 (GLP-1) receptor agonists led to a significant reduction in the risk for venous thromboembolism (VTE) among individuals with type 2 diabetes, compared with dipeptidyl peptidase 4 (DPP-4) inhibitors, a recent analysis indicated.

Overall, GLP-1 agonist use was associated with a 20% reduction in VTE, compared with DPP-4 inhibitor use, in those with type 2 diabetes, and this benefit held regardless of people’s obesity status, said study investigator Cho-Han Chiang, MD, a medical resident at Mount Auburn Hospital, Cambridge, Massachusetts, who presented the findings at the American Society of Hematology (ASH) 2024 Annual Meeting.

The incidence of VTE has increased by 20% over the past 10 years, and obesity is a risk factor for VTE, Chiang explained. A growing body of evidence demonstrated that GLP-1s provide a variety of cardiovascular benefits in people with type 2 diabetes, but data on VTE benefits remain more limited.

In the retrospective study, the researchers combed electronic health records from the TriNetX global database, which includes more than 250 million patients, and identified adults with type 2 diabetes who were taking a GLP-1 agonist or a DPP-4 inhibitor.

After excluding anyone with prior VTE or atrial fibrillation as well as those treated with both drugs or with oral anticoagulants, patients on GLP-1s were matched with those on DPP-4 inhibitors based on predetermined variables, including age, sex, race, body mass index (BMI), hemoglobin A1c, use of other antidiabetic agents, and underlying comorbidities. VTE was a composite of pulmonary embolism and deep vein thrombosis.

The researchers also performed a subgroup analysis that stratified patients by obesity status, defined as a BMI ≥ 30.

Within 1 year of GLP-1 or DPP-4 prescription, VTE occurred at a rate of 6.5 cases/1000 person-years in the GLP-1 group vs 7.9 cases/1000 person years in the DPP-4 inhibitor group (hazard ratio [HR], 0.80; P < .001).

The 20% risk reduction in VTE held across various subgroups of BMI, including among those with obesity, Chiang reported.

Among patients with the highest BMI (≥ 40), VTE occurred at a rate of 7.2 cases/1000 person years in the GLP-1 group vs 9.6 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.74). Among patients with the next highest BMI (30-34.9), VTE occurred at a rate of 4.8 cases/1000 person years in the GLP-1 group vs 7.9 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.60). Among those with the lowest BMI (18.5-24.9), VTE occurred significantly less frequently among those in the GLP-1 group — 4.7 cases/1000 person years vs 7.4 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.61).

The lower risk for VTE associated with GLP-1s also held across the individual components of the composite VTE. Pulmonary embolism occurred at a rate of 3.1 cases/1000 person years in the GLP-1 group vs 3.9 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.78), and deep vein thrombosis occurred in 4.2 cases/1000 person years in the GLP-1 group vs 5.0 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.82).

Interestingly, the GLP-1 and DPP-4 curves started diverging within the first 30 days of the index prescription date, said Chiang.

Session moderator Ghadeer Dawwas, PhD, said in an interview that patients with type 2 diabetes are increasingly using GLP-1 agonists because of the cardiovascular benefits associated with the agents, which include lower risks for stroke and heart failure, but the antithrombotic benefits are still debated.

“The current study indicates that GLP-1 agonists may help lower the risk of VTE in patients with type 2 diabetes, irrespective of their baseline body weight,” said Dawwas, a pharmacoepidemiologist and assistant professor of medicine at Vanderbilt University Medical Center in Nashville, Tennessee. “However, given the current landscape of evidence and the existence of conflicting data on VTE risk, clinicians should proceed with caution and await further studies to validate these findings before making clinical decisions.”

This study was funded by the National Blood Clot Alliance and Conquer Cancer Foundation. Chiang and Dawwas had no disclosures.

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM ASH 2024

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Un-Gate On Date
Use ProPublica
CFC Schedule Remove Status
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date

Vertebral Fractures and Myeloma: Link Is Questionable

Article Type
Changed

— Incidentally discovered vertebral fractures are common on scans in the general population, while the absolute risk for multiple myeloma (MM) in those with such fractures is “quite modest,” according to findings in a Danish cohort of more than 9000 patients.

The findings suggest that evaluation for underlying MM — as recommended in some clinical guidelines — may be unwarranted in the absence of symptoms or other clinical findings leading to suspicion of underlying MM, Rasmus Rønnemoes, MD, reported during a poster session at the annual American Society of Hematology conference.

“Some guidelines say to evaluate patients with vertebral fractures, including measuring serum M-protein and free light chains, and others say to evaluate only if there is an indication — but without specifying what an indication is,” Rønnemoes, of the Danish Red Blood Cell Center, Copenhagen University Hospital — Rigshospitalet, Denmark, said in an interview. 

To assess the association between vertebral fractures and MM, he and his colleagues studied 9065 individuals from the Danish general population, aged 33-94 years (median, 62 years) who were part of the Copenhagen General Population Study and who had attended a health examination and underwent a CT scan as part of the study. Overall, 1574 (17.4%) had one or more incidentally discovered vertebral fracture on the CT scan, and of those, 875 (9.7%) had a grade 1 fracture as the highest grade and 699 (7.7%) had grade 2-3 fractures.

During a median prospective follow-up of 5.5 years after the scan, 13 were diagnosed with myeloma.

“We did find an increased relative risk of myeloma in these patients, which we thought was quite interesting, but the absolute risk was quite modest,” Rønnemoes said.

The absolute 5-year risk for MM was 0.07% and 0.10% in women and men without vertebral fractures, respectively, and the risk for those with fractures was 0.17% and 0.24% in women and men with grade 1 fractures, respectively, and 0.43% and 0.63% in women and men with grade 2-3 fractures, respectively.

A case-cohort study based on more than 56,000 individuals from the UK Biobank cohort who had undergone a dual-energy x-ray absorptiometry scan as part of that study validated the findings in the Danish population: At median follow-up of 4 years, 49 patients in the validation cohort were diagnosed with myeloma, and the absolute 5-year risk for myeloma was 0.06% and 0.12% in women and men with grade 1 fractures, respectively, and 0.14% and 0.26% in women and men with grade 2-3 fractures, respectively.

Given the apparently modest absolute risk for MM in patients with incidentally discovered fractures in the absence of strong indications or risk, treatment guidelines should consider the potential harms associated with additional work up and a monoclonal gammopathy of undetermined significance diagnosis, Rønnemoes said. 

Such a diagnosis can lead to psychological distress in individuals who may never develop malignant disease, he noted.

“We just hope to bring more value to the guidelines by identifying who should be evaluated,” he said, adding that additional study — perhaps looking more closely at whether only the more severe fractures should prompt additional evaluation — is warranted.

Rønnemoes reported no disclosures.

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

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

— Incidentally discovered vertebral fractures are common on scans in the general population, while the absolute risk for multiple myeloma (MM) in those with such fractures is “quite modest,” according to findings in a Danish cohort of more than 9000 patients.

The findings suggest that evaluation for underlying MM — as recommended in some clinical guidelines — may be unwarranted in the absence of symptoms or other clinical findings leading to suspicion of underlying MM, Rasmus Rønnemoes, MD, reported during a poster session at the annual American Society of Hematology conference.

“Some guidelines say to evaluate patients with vertebral fractures, including measuring serum M-protein and free light chains, and others say to evaluate only if there is an indication — but without specifying what an indication is,” Rønnemoes, of the Danish Red Blood Cell Center, Copenhagen University Hospital — Rigshospitalet, Denmark, said in an interview. 

To assess the association between vertebral fractures and MM, he and his colleagues studied 9065 individuals from the Danish general population, aged 33-94 years (median, 62 years) who were part of the Copenhagen General Population Study and who had attended a health examination and underwent a CT scan as part of the study. Overall, 1574 (17.4%) had one or more incidentally discovered vertebral fracture on the CT scan, and of those, 875 (9.7%) had a grade 1 fracture as the highest grade and 699 (7.7%) had grade 2-3 fractures.

During a median prospective follow-up of 5.5 years after the scan, 13 were diagnosed with myeloma.

“We did find an increased relative risk of myeloma in these patients, which we thought was quite interesting, but the absolute risk was quite modest,” Rønnemoes said.

The absolute 5-year risk for MM was 0.07% and 0.10% in women and men without vertebral fractures, respectively, and the risk for those with fractures was 0.17% and 0.24% in women and men with grade 1 fractures, respectively, and 0.43% and 0.63% in women and men with grade 2-3 fractures, respectively.

A case-cohort study based on more than 56,000 individuals from the UK Biobank cohort who had undergone a dual-energy x-ray absorptiometry scan as part of that study validated the findings in the Danish population: At median follow-up of 4 years, 49 patients in the validation cohort were diagnosed with myeloma, and the absolute 5-year risk for myeloma was 0.06% and 0.12% in women and men with grade 1 fractures, respectively, and 0.14% and 0.26% in women and men with grade 2-3 fractures, respectively.

Given the apparently modest absolute risk for MM in patients with incidentally discovered fractures in the absence of strong indications or risk, treatment guidelines should consider the potential harms associated with additional work up and a monoclonal gammopathy of undetermined significance diagnosis, Rønnemoes said. 

Such a diagnosis can lead to psychological distress in individuals who may never develop malignant disease, he noted.

“We just hope to bring more value to the guidelines by identifying who should be evaluated,” he said, adding that additional study — perhaps looking more closely at whether only the more severe fractures should prompt additional evaluation — is warranted.

Rønnemoes reported no disclosures.

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

— Incidentally discovered vertebral fractures are common on scans in the general population, while the absolute risk for multiple myeloma (MM) in those with such fractures is “quite modest,” according to findings in a Danish cohort of more than 9000 patients.

The findings suggest that evaluation for underlying MM — as recommended in some clinical guidelines — may be unwarranted in the absence of symptoms or other clinical findings leading to suspicion of underlying MM, Rasmus Rønnemoes, MD, reported during a poster session at the annual American Society of Hematology conference.

“Some guidelines say to evaluate patients with vertebral fractures, including measuring serum M-protein and free light chains, and others say to evaluate only if there is an indication — but without specifying what an indication is,” Rønnemoes, of the Danish Red Blood Cell Center, Copenhagen University Hospital — Rigshospitalet, Denmark, said in an interview. 

To assess the association between vertebral fractures and MM, he and his colleagues studied 9065 individuals from the Danish general population, aged 33-94 years (median, 62 years) who were part of the Copenhagen General Population Study and who had attended a health examination and underwent a CT scan as part of the study. Overall, 1574 (17.4%) had one or more incidentally discovered vertebral fracture on the CT scan, and of those, 875 (9.7%) had a grade 1 fracture as the highest grade and 699 (7.7%) had grade 2-3 fractures.

During a median prospective follow-up of 5.5 years after the scan, 13 were diagnosed with myeloma.

“We did find an increased relative risk of myeloma in these patients, which we thought was quite interesting, but the absolute risk was quite modest,” Rønnemoes said.

The absolute 5-year risk for MM was 0.07% and 0.10% in women and men without vertebral fractures, respectively, and the risk for those with fractures was 0.17% and 0.24% in women and men with grade 1 fractures, respectively, and 0.43% and 0.63% in women and men with grade 2-3 fractures, respectively.

A case-cohort study based on more than 56,000 individuals from the UK Biobank cohort who had undergone a dual-energy x-ray absorptiometry scan as part of that study validated the findings in the Danish population: At median follow-up of 4 years, 49 patients in the validation cohort were diagnosed with myeloma, and the absolute 5-year risk for myeloma was 0.06% and 0.12% in women and men with grade 1 fractures, respectively, and 0.14% and 0.26% in women and men with grade 2-3 fractures, respectively.

Given the apparently modest absolute risk for MM in patients with incidentally discovered fractures in the absence of strong indications or risk, treatment guidelines should consider the potential harms associated with additional work up and a monoclonal gammopathy of undetermined significance diagnosis, Rønnemoes said. 

Such a diagnosis can lead to psychological distress in individuals who may never develop malignant disease, he noted.

“We just hope to bring more value to the guidelines by identifying who should be evaluated,” he said, adding that additional study — perhaps looking more closely at whether only the more severe fractures should prompt additional evaluation — is warranted.

Rønnemoes reported no disclosures.

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

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM ASH 2024

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Un-Gate On Date
Use ProPublica
CFC Schedule Remove Status
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date

CGM Use, GLP-1s, Drinking Water Key of 2025 ADA Standards

Article Type
Changed

The American Diabetes Association (ADA)’s Standards of Care — 2025 offer new guidance on broader use of continuous glucose monitoring (CGM), use of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) beyond weight loss, management of metabolic dysfunction-associated liver disease (MAFLD), plus a strong endorsement for drinking water and much more. 

The Standards of Care — 2025 were published December 9 as a supplement to Diabetes Care. The standards “incorporate the latest information from clinical trial data and knowledge of diabetes management into a comprehensive guidelines document that will assist physicians in managing patients with diabetes in their practices,” said Mandeep Bajaj, MBBS, ADA’s President, Medicine & Science.

In an interview, Bajaj highlighted some of the most important of the clinical updates in 2024, including the following: 

  • Consideration of the use of continuous glucose monitoring devices in adults with type 2 diabetes (T2D) who don’t use insulin. Medicare and many other payers currently only cover CGM for people who use insulin or are otherwise at risk for hypoglycemia. However, some CGMs are now available over the counter, Bajaj pointed out.
  • Actions to be taken in the event of medication shortages. The ADA published guidance for this in the case of GLP-1 RAs on December 2. Essentially ADA advised substituting a different GLP-1 RA if possible. Nonapproved products aren’t recommended, but guidance is provided for people who choose to use them.
  • Use of GLP-1 RAs for heart and kidney health. Recommendations were revised to explicitly advise on choice of pharmacotherapy for individuals with T2D, based on new data on those with established or high risk for atherosclerotic cardiovascular disease, heart failure with preserved ejection fraction, and chronic kidney disease.
  • Treatment of MAFLD with moderate or advanced liver fibrosis. A new recommendation for use of a thyroid hormone receptor–beta agonist is based on trial data for resmetirom. Moreover, Bajaj noted, “we’ve adopted the new nomenclature, which was previously NAFLD and NASH, and now is MAFLD and MASH [metabolic-associated steatohepatitis].”
  • Advice to continue weight management therapy beyond achieving weight loss goals. This is based on a large amount of evidence that “stopping these therapies are associated with weight regain and increased cardiovascular risk,” Bajaj said, adding that this recommendation was made in collaboration with the Obesity Society.
  • Antibody-based screening for presymptomatic T1D in family members of people with T2D and others who may be at risk. “Individuals who test autoantibody positive should be provided with or referred for counseling about the risk of developing diabetes, diabetes symptoms, and [diabetic ketoacidosis] prevention and should be given consideration for referral to a specialized center for further evaluation and/or consideration of a clinical trial or approved therapy to potentially delay development of clinical diabetes,” the document says.
  • Screen for psychosocial issues. People with diabetes should be screened for concerns including diabetes distress, depression, anxiety, fear of hypoglycemia, and disordered eating behaviors. “People on insulin or sulfonylureas may have fear of hypoglycemia, but diabetes distress can happen to anyone with diabetes,” Bajaj pointed out. Caregivers and family members should be screened as well, the document advises.
  • Drink water, not soda. In the nutrition section, a new recommendation strongly advises drinking water instead of nutritive or nonnutritive sweetened beverages. “This is an important recommendation. So, when patients ask what’s the best thing to drink, our answer is drink water rather than Coca Cola or Diet Coke,” Bajaj said. But, what about people with diabetes who can’t quit their diet soda habit? “We’ve said that the nonnutritive sweetener is preferred over sugar sweetener, provided it’s in moderation and short term ... but the best is water.”

Bajaj has received grant support from ADA. He had no further disclosures.

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

Publications
Topics
Sections

The American Diabetes Association (ADA)’s Standards of Care — 2025 offer new guidance on broader use of continuous glucose monitoring (CGM), use of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) beyond weight loss, management of metabolic dysfunction-associated liver disease (MAFLD), plus a strong endorsement for drinking water and much more. 

The Standards of Care — 2025 were published December 9 as a supplement to Diabetes Care. The standards “incorporate the latest information from clinical trial data and knowledge of diabetes management into a comprehensive guidelines document that will assist physicians in managing patients with diabetes in their practices,” said Mandeep Bajaj, MBBS, ADA’s President, Medicine & Science.

In an interview, Bajaj highlighted some of the most important of the clinical updates in 2024, including the following: 

  • Consideration of the use of continuous glucose monitoring devices in adults with type 2 diabetes (T2D) who don’t use insulin. Medicare and many other payers currently only cover CGM for people who use insulin or are otherwise at risk for hypoglycemia. However, some CGMs are now available over the counter, Bajaj pointed out.
  • Actions to be taken in the event of medication shortages. The ADA published guidance for this in the case of GLP-1 RAs on December 2. Essentially ADA advised substituting a different GLP-1 RA if possible. Nonapproved products aren’t recommended, but guidance is provided for people who choose to use them.
  • Use of GLP-1 RAs for heart and kidney health. Recommendations were revised to explicitly advise on choice of pharmacotherapy for individuals with T2D, based on new data on those with established or high risk for atherosclerotic cardiovascular disease, heart failure with preserved ejection fraction, and chronic kidney disease.
  • Treatment of MAFLD with moderate or advanced liver fibrosis. A new recommendation for use of a thyroid hormone receptor–beta agonist is based on trial data for resmetirom. Moreover, Bajaj noted, “we’ve adopted the new nomenclature, which was previously NAFLD and NASH, and now is MAFLD and MASH [metabolic-associated steatohepatitis].”
  • Advice to continue weight management therapy beyond achieving weight loss goals. This is based on a large amount of evidence that “stopping these therapies are associated with weight regain and increased cardiovascular risk,” Bajaj said, adding that this recommendation was made in collaboration with the Obesity Society.
  • Antibody-based screening for presymptomatic T1D in family members of people with T2D and others who may be at risk. “Individuals who test autoantibody positive should be provided with or referred for counseling about the risk of developing diabetes, diabetes symptoms, and [diabetic ketoacidosis] prevention and should be given consideration for referral to a specialized center for further evaluation and/or consideration of a clinical trial or approved therapy to potentially delay development of clinical diabetes,” the document says.
  • Screen for psychosocial issues. People with diabetes should be screened for concerns including diabetes distress, depression, anxiety, fear of hypoglycemia, and disordered eating behaviors. “People on insulin or sulfonylureas may have fear of hypoglycemia, but diabetes distress can happen to anyone with diabetes,” Bajaj pointed out. Caregivers and family members should be screened as well, the document advises.
  • Drink water, not soda. In the nutrition section, a new recommendation strongly advises drinking water instead of nutritive or nonnutritive sweetened beverages. “This is an important recommendation. So, when patients ask what’s the best thing to drink, our answer is drink water rather than Coca Cola or Diet Coke,” Bajaj said. But, what about people with diabetes who can’t quit their diet soda habit? “We’ve said that the nonnutritive sweetener is preferred over sugar sweetener, provided it’s in moderation and short term ... but the best is water.”

Bajaj has received grant support from ADA. He had no further disclosures.

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

The American Diabetes Association (ADA)’s Standards of Care — 2025 offer new guidance on broader use of continuous glucose monitoring (CGM), use of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) beyond weight loss, management of metabolic dysfunction-associated liver disease (MAFLD), plus a strong endorsement for drinking water and much more. 

The Standards of Care — 2025 were published December 9 as a supplement to Diabetes Care. The standards “incorporate the latest information from clinical trial data and knowledge of diabetes management into a comprehensive guidelines document that will assist physicians in managing patients with diabetes in their practices,” said Mandeep Bajaj, MBBS, ADA’s President, Medicine & Science.

In an interview, Bajaj highlighted some of the most important of the clinical updates in 2024, including the following: 

  • Consideration of the use of continuous glucose monitoring devices in adults with type 2 diabetes (T2D) who don’t use insulin. Medicare and many other payers currently only cover CGM for people who use insulin or are otherwise at risk for hypoglycemia. However, some CGMs are now available over the counter, Bajaj pointed out.
  • Actions to be taken in the event of medication shortages. The ADA published guidance for this in the case of GLP-1 RAs on December 2. Essentially ADA advised substituting a different GLP-1 RA if possible. Nonapproved products aren’t recommended, but guidance is provided for people who choose to use them.
  • Use of GLP-1 RAs for heart and kidney health. Recommendations were revised to explicitly advise on choice of pharmacotherapy for individuals with T2D, based on new data on those with established or high risk for atherosclerotic cardiovascular disease, heart failure with preserved ejection fraction, and chronic kidney disease.
  • Treatment of MAFLD with moderate or advanced liver fibrosis. A new recommendation for use of a thyroid hormone receptor–beta agonist is based on trial data for resmetirom. Moreover, Bajaj noted, “we’ve adopted the new nomenclature, which was previously NAFLD and NASH, and now is MAFLD and MASH [metabolic-associated steatohepatitis].”
  • Advice to continue weight management therapy beyond achieving weight loss goals. This is based on a large amount of evidence that “stopping these therapies are associated with weight regain and increased cardiovascular risk,” Bajaj said, adding that this recommendation was made in collaboration with the Obesity Society.
  • Antibody-based screening for presymptomatic T1D in family members of people with T2D and others who may be at risk. “Individuals who test autoantibody positive should be provided with or referred for counseling about the risk of developing diabetes, diabetes symptoms, and [diabetic ketoacidosis] prevention and should be given consideration for referral to a specialized center for further evaluation and/or consideration of a clinical trial or approved therapy to potentially delay development of clinical diabetes,” the document says.
  • Screen for psychosocial issues. People with diabetes should be screened for concerns including diabetes distress, depression, anxiety, fear of hypoglycemia, and disordered eating behaviors. “People on insulin or sulfonylureas may have fear of hypoglycemia, but diabetes distress can happen to anyone with diabetes,” Bajaj pointed out. Caregivers and family members should be screened as well, the document advises.
  • Drink water, not soda. In the nutrition section, a new recommendation strongly advises drinking water instead of nutritive or nonnutritive sweetened beverages. “This is an important recommendation. So, when patients ask what’s the best thing to drink, our answer is drink water rather than Coca Cola or Diet Coke,” Bajaj said. But, what about people with diabetes who can’t quit their diet soda habit? “We’ve said that the nonnutritive sweetener is preferred over sugar sweetener, provided it’s in moderation and short term ... but the best is water.”

Bajaj has received grant support from ADA. He had no further disclosures.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Un-Gate On Date
Use ProPublica
CFC Schedule Remove Status
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date

Self-Care Can Elevate Quality of Life in Chronic Diseases

Article Type
Changed

TOPLINE:

Self-care preparedness is positively associated with improved health-related quality of life (HRQOL) in patients with chronic conditions over 36 months, and patients who enhance their self-care preparedness experience better QOL outcomes.

METHODOLOGY:

  • A secondary analysis of a randomized controlled trial conducted in Finland from 2017 to 2021 aimed to analyze the longitudinal associations between self-care preparedness and HRQOL over a 36-month follow-up period.
  • A total of 256 adults with hypertension, diabetes, or coronary artery disease who participated in a patient care planning process in primary healthcare and completed the self-care intervention were included.
  • The intervention comprised individualized care plans with a self-care form, including the self-care preparedness index (SCPI), which was initially mailed to the participants; the form explained self-care concepts and included assessments of health behaviors and willingness to change.
  • Self-care preparedness was measured using SCPI scores, which were divided into tertiles: Low (−5 to 0), moderate (1-3), and high (4-5) preparedness.
  • Outcome measures assessed at baseline and at 12 and 36 months included changes in the SCPI; HRQOL, assessed using 15D, which is a 15-dimensional measure; depressive symptoms; self-rated health; life satisfaction; and physical activity. The associations were analyzed using regression models.

TAKEAWAY:

  • At baseline, participants with a higher SCPI score showed higher physical activity, life satisfaction, self-rated health, and management of their overall health; however, body mass index and the presence of depressive symptoms had a negative relationship with SCPI.
  • Various dimensions of 15D, particularly usual activities, discomfort and symptoms, distress, depression, vitality, and sexual activity, showed a positive linear relationship with SCPI at baseline.
  • A lower SCPI score at baseline was associated with greater improvements in the measures of HRQOL.
  • A significant positive longitudinal association was observed between changes in SCPI and 15D from baseline to 36 months (beta coefficient, +0.19; P = .002), showing that QOL can improve if patients manage to improve their SCPI.

IN PRACTICE:

“SCPI could be used as an indicative index, keeping in mind that participants with lower SCPI have the potential to benefit and change their health behavior the most. The patient and the healthcare provider should consider which areas of self-care the patient needs support,” the authors wrote. “This study provides further knowledge of this tool for the purpose of aiding healthcare professionals in screening self-care preparedness in primary healthcare,” they added.

SOURCE:

The study was led by Ulla Mikkonen, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland. It was published online in Family Practice.

LIMITATIONS:

The relatively small sample size limited to a local area in Finland may have affected the generalizability of the findings. Additionally, variations in the implementation of the intervention in real-life settings could have influenced the results. The data on whether general practitioners used the SCPI to formulate care plans were lacking.

DISCLOSURES:

The study received funding from the Primary Health Care Unit of the Northern Savo Hospital District and Siilinjärvi Health Center. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

TOPLINE:

Self-care preparedness is positively associated with improved health-related quality of life (HRQOL) in patients with chronic conditions over 36 months, and patients who enhance their self-care preparedness experience better QOL outcomes.

METHODOLOGY:

  • A secondary analysis of a randomized controlled trial conducted in Finland from 2017 to 2021 aimed to analyze the longitudinal associations between self-care preparedness and HRQOL over a 36-month follow-up period.
  • A total of 256 adults with hypertension, diabetes, or coronary artery disease who participated in a patient care planning process in primary healthcare and completed the self-care intervention were included.
  • The intervention comprised individualized care plans with a self-care form, including the self-care preparedness index (SCPI), which was initially mailed to the participants; the form explained self-care concepts and included assessments of health behaviors and willingness to change.
  • Self-care preparedness was measured using SCPI scores, which were divided into tertiles: Low (−5 to 0), moderate (1-3), and high (4-5) preparedness.
  • Outcome measures assessed at baseline and at 12 and 36 months included changes in the SCPI; HRQOL, assessed using 15D, which is a 15-dimensional measure; depressive symptoms; self-rated health; life satisfaction; and physical activity. The associations were analyzed using regression models.

TAKEAWAY:

  • At baseline, participants with a higher SCPI score showed higher physical activity, life satisfaction, self-rated health, and management of their overall health; however, body mass index and the presence of depressive symptoms had a negative relationship with SCPI.
  • Various dimensions of 15D, particularly usual activities, discomfort and symptoms, distress, depression, vitality, and sexual activity, showed a positive linear relationship with SCPI at baseline.
  • A lower SCPI score at baseline was associated with greater improvements in the measures of HRQOL.
  • A significant positive longitudinal association was observed between changes in SCPI and 15D from baseline to 36 months (beta coefficient, +0.19; P = .002), showing that QOL can improve if patients manage to improve their SCPI.

IN PRACTICE:

“SCPI could be used as an indicative index, keeping in mind that participants with lower SCPI have the potential to benefit and change their health behavior the most. The patient and the healthcare provider should consider which areas of self-care the patient needs support,” the authors wrote. “This study provides further knowledge of this tool for the purpose of aiding healthcare professionals in screening self-care preparedness in primary healthcare,” they added.

SOURCE:

The study was led by Ulla Mikkonen, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland. It was published online in Family Practice.

LIMITATIONS:

The relatively small sample size limited to a local area in Finland may have affected the generalizability of the findings. Additionally, variations in the implementation of the intervention in real-life settings could have influenced the results. The data on whether general practitioners used the SCPI to formulate care plans were lacking.

DISCLOSURES:

The study received funding from the Primary Health Care Unit of the Northern Savo Hospital District and Siilinjärvi Health Center. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Self-care preparedness is positively associated with improved health-related quality of life (HRQOL) in patients with chronic conditions over 36 months, and patients who enhance their self-care preparedness experience better QOL outcomes.

METHODOLOGY:

  • A secondary analysis of a randomized controlled trial conducted in Finland from 2017 to 2021 aimed to analyze the longitudinal associations between self-care preparedness and HRQOL over a 36-month follow-up period.
  • A total of 256 adults with hypertension, diabetes, or coronary artery disease who participated in a patient care planning process in primary healthcare and completed the self-care intervention were included.
  • The intervention comprised individualized care plans with a self-care form, including the self-care preparedness index (SCPI), which was initially mailed to the participants; the form explained self-care concepts and included assessments of health behaviors and willingness to change.
  • Self-care preparedness was measured using SCPI scores, which were divided into tertiles: Low (−5 to 0), moderate (1-3), and high (4-5) preparedness.
  • Outcome measures assessed at baseline and at 12 and 36 months included changes in the SCPI; HRQOL, assessed using 15D, which is a 15-dimensional measure; depressive symptoms; self-rated health; life satisfaction; and physical activity. The associations were analyzed using regression models.

TAKEAWAY:

  • At baseline, participants with a higher SCPI score showed higher physical activity, life satisfaction, self-rated health, and management of their overall health; however, body mass index and the presence of depressive symptoms had a negative relationship with SCPI.
  • Various dimensions of 15D, particularly usual activities, discomfort and symptoms, distress, depression, vitality, and sexual activity, showed a positive linear relationship with SCPI at baseline.
  • A lower SCPI score at baseline was associated with greater improvements in the measures of HRQOL.
  • A significant positive longitudinal association was observed between changes in SCPI and 15D from baseline to 36 months (beta coefficient, +0.19; P = .002), showing that QOL can improve if patients manage to improve their SCPI.

IN PRACTICE:

“SCPI could be used as an indicative index, keeping in mind that participants with lower SCPI have the potential to benefit and change their health behavior the most. The patient and the healthcare provider should consider which areas of self-care the patient needs support,” the authors wrote. “This study provides further knowledge of this tool for the purpose of aiding healthcare professionals in screening self-care preparedness in primary healthcare,” they added.

SOURCE:

The study was led by Ulla Mikkonen, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland. It was published online in Family Practice.

LIMITATIONS:

The relatively small sample size limited to a local area in Finland may have affected the generalizability of the findings. Additionally, variations in the implementation of the intervention in real-life settings could have influenced the results. The data on whether general practitioners used the SCPI to formulate care plans were lacking.

DISCLOSURES:

The study received funding from the Primary Health Care Unit of the Northern Savo Hospital District and Siilinjärvi Health Center. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Un-Gate On Date
Use ProPublica
CFC Schedule Remove Status
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date

USPSTF Updates Recommendations on Cervical Cancer Screening

Article Type
Changed

The US Preventive Services Task Force (USPSTF) has posted a draft updated statement on cervical cancer screening. The statement is open for public comment until January 13, 2025, on the task force’s website. 

Nearly all cases of cervical cancer are caused by human papilloma virus (HPV) and most occur in women who have not been regularly screened or appropriately treated, the task force stressed.
 

New Screening Option

In 2024, there will be an estimated 13,820 new cases of cervical cancer and 4360 deaths.

“Evidence shows that screening saves lives, and all women aged 21-65 need to be screened,” task force member Esa Davis, MD, MPH, FAAFP, a professor of family and community medicine and associate vice president for community health at the University of Maryland, Baltimore, said in an interview. A new feature in the 2024 draft statement endorsing self-collection of cervical samples for HPV testing may facilitate broader screening. 

“We hope the new effective option of self-collecting will expand screening and allow even more women to get screened regularly,” Davis said. “Some may feel more comfortable collecting samples themselves, and the collection can be office-based or home-based, but it’s very important that it be done under the direction of a clinician.” 

In agreement is Diego Aviles, MD, an assistant professor and a gynecologic oncologist with UTHealth Houston. “Self-collection will absolutely expand screening. I think it’s an incredible advancement in medicine that patients are able to collect in the comfort of their own homes with no need to come into the office for an uncomfortable pelvic exam,” he said in an interview. “This empowers the patient and gives her a choice.”

As to concern about potential error, he added that while this is a concern on paper, “a lot of studies have shown that self-collection is just as effective doctor collection.” 

Largely consistent with the task force’s 2018 screening recommendations, the updated suggestions also align with those of other organizations such as the American College of Obstetricians and Gynecologists (ACOG), Davis said.

Christopher M. Zahn, MD, ACOG’s chief of clinical practice and health equity and quality, stressed the importance of cervical cancer screening and said his organization will be reviewing the USPSTF recommendations. He urges ACOG members to consider them and offer their comments on the public-input platform.

Drawing on the latest evidence, the task force is also highlighting for the first time that stand-alone HPV screening gives women aged 30-65 years the best balance of benefits and harms when it comes to finding and preventing cervical cancer, while continuing to reinforce that Pap testing and co-testing are also effective screening options for these women. 

The current draft statement applies to cisgender women and those assigned female sex at birth, including transgender men and nonbinary individuals. The recommendations do not apply to women at increased risk of cervical cancer such as those with HIV infection, a compromised immune system, or a history of treatment for precancerous lesions or cervical cancer. 

Based on a review of evidence on the benefits and harms of screening, the USPSTF’s independent panel of national experts proposed the following:
 

Recommendations for Screening (Based on Grade A Evidence):

  • Ages 21-65 years: All women should get screened regularly for this preventable disease.
  • Ages 21-29 years: All women in this age group should undergo a Pap test every 3 years but do not need HPV testing. “In this age group most HPV infections will go away on their own because young women have strong immune systems. Older women are likely to have HPV that lasts longer and so they need testing for the virus,” Davis said.
  • Ages 30-65 years: As noted, HPV screening gives women in this age category the best balance of benefits and harms in terms of preventing and finding cervical cancer. Pap testing or co-testing (Pap tests and HPV tests) are also effective screening options for this population. Ideally, these women should have an HPV test every 5 years or, alternatively, a Pap test every 3 years, or a combined HPV and Pap test every 5 years (co-testing).

Recommendations Against Screening (No Benefit or Benefit Outweighed by Harms — Grade D evidence):

  • Women aged less than 21 years: Screening is not necessary.
  • Other women not needing screening: Nor is screening necessary for those of any age who have had a total hysterectomy with removal of the cervix and those aged > 65 years who have had regular screenings with normal results. That means normal results from their last three Pap tests or their last two HPV tests, completed in the past 10 years, with at least one of the tests done in the past 5 years.
  • Women aged 65 or more: These women should continue screening only if they have not been screened regularly or have had abnormal results in the past decade such as a high-grade precancerous lesion (cervical intraepithelial neoplasia grade 2 or 3) or cervical cancer.

Davis noted that none of the current recommendations are likely to be controversial or to spark pushback. “But,” said Aviles, “any time I see recent change in medicine, there’s always a little bit of pushback and it may take some time for everyone to be comfortable with the self-collection option. The recommendations still give doctors the grace to use the screening test they feel comfortable with, but I think eventually everyone will get on board with self-collection.”

As for the future, he added, “Over the next few years we’ll have to look at women who are on immune-weakening medications like Skyrizi [risankizumab] for skin conditions like psoriasis. These are commonly used in young people and can increase the risk of cervical cancer. I haven’t seen a lot of conversation about this, but patients should be aware of this risk and recommendations for this group should be different than for the general population.”

The USPSTF also noted a need to assess the magnitude of the incremental benefit and harms of screening and the interval of multiple rounds of HPV-primary screening in HPV-vaccinated cohorts in US populations.

Davis, Aviles, and Zahn and had no relevant competing interests to disclose.
 

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

Publications
Topics
Sections

The US Preventive Services Task Force (USPSTF) has posted a draft updated statement on cervical cancer screening. The statement is open for public comment until January 13, 2025, on the task force’s website. 

Nearly all cases of cervical cancer are caused by human papilloma virus (HPV) and most occur in women who have not been regularly screened or appropriately treated, the task force stressed.
 

New Screening Option

In 2024, there will be an estimated 13,820 new cases of cervical cancer and 4360 deaths.

“Evidence shows that screening saves lives, and all women aged 21-65 need to be screened,” task force member Esa Davis, MD, MPH, FAAFP, a professor of family and community medicine and associate vice president for community health at the University of Maryland, Baltimore, said in an interview. A new feature in the 2024 draft statement endorsing self-collection of cervical samples for HPV testing may facilitate broader screening. 

“We hope the new effective option of self-collecting will expand screening and allow even more women to get screened regularly,” Davis said. “Some may feel more comfortable collecting samples themselves, and the collection can be office-based or home-based, but it’s very important that it be done under the direction of a clinician.” 

In agreement is Diego Aviles, MD, an assistant professor and a gynecologic oncologist with UTHealth Houston. “Self-collection will absolutely expand screening. I think it’s an incredible advancement in medicine that patients are able to collect in the comfort of their own homes with no need to come into the office for an uncomfortable pelvic exam,” he said in an interview. “This empowers the patient and gives her a choice.”

As to concern about potential error, he added that while this is a concern on paper, “a lot of studies have shown that self-collection is just as effective doctor collection.” 

Largely consistent with the task force’s 2018 screening recommendations, the updated suggestions also align with those of other organizations such as the American College of Obstetricians and Gynecologists (ACOG), Davis said.

Christopher M. Zahn, MD, ACOG’s chief of clinical practice and health equity and quality, stressed the importance of cervical cancer screening and said his organization will be reviewing the USPSTF recommendations. He urges ACOG members to consider them and offer their comments on the public-input platform.

Drawing on the latest evidence, the task force is also highlighting for the first time that stand-alone HPV screening gives women aged 30-65 years the best balance of benefits and harms when it comes to finding and preventing cervical cancer, while continuing to reinforce that Pap testing and co-testing are also effective screening options for these women. 

The current draft statement applies to cisgender women and those assigned female sex at birth, including transgender men and nonbinary individuals. The recommendations do not apply to women at increased risk of cervical cancer such as those with HIV infection, a compromised immune system, or a history of treatment for precancerous lesions or cervical cancer. 

Based on a review of evidence on the benefits and harms of screening, the USPSTF’s independent panel of national experts proposed the following:
 

Recommendations for Screening (Based on Grade A Evidence):

  • Ages 21-65 years: All women should get screened regularly for this preventable disease.
  • Ages 21-29 years: All women in this age group should undergo a Pap test every 3 years but do not need HPV testing. “In this age group most HPV infections will go away on their own because young women have strong immune systems. Older women are likely to have HPV that lasts longer and so they need testing for the virus,” Davis said.
  • Ages 30-65 years: As noted, HPV screening gives women in this age category the best balance of benefits and harms in terms of preventing and finding cervical cancer. Pap testing or co-testing (Pap tests and HPV tests) are also effective screening options for this population. Ideally, these women should have an HPV test every 5 years or, alternatively, a Pap test every 3 years, or a combined HPV and Pap test every 5 years (co-testing).

Recommendations Against Screening (No Benefit or Benefit Outweighed by Harms — Grade D evidence):

  • Women aged less than 21 years: Screening is not necessary.
  • Other women not needing screening: Nor is screening necessary for those of any age who have had a total hysterectomy with removal of the cervix and those aged > 65 years who have had regular screenings with normal results. That means normal results from their last three Pap tests or their last two HPV tests, completed in the past 10 years, with at least one of the tests done in the past 5 years.
  • Women aged 65 or more: These women should continue screening only if they have not been screened regularly or have had abnormal results in the past decade such as a high-grade precancerous lesion (cervical intraepithelial neoplasia grade 2 or 3) or cervical cancer.

Davis noted that none of the current recommendations are likely to be controversial or to spark pushback. “But,” said Aviles, “any time I see recent change in medicine, there’s always a little bit of pushback and it may take some time for everyone to be comfortable with the self-collection option. The recommendations still give doctors the grace to use the screening test they feel comfortable with, but I think eventually everyone will get on board with self-collection.”

As for the future, he added, “Over the next few years we’ll have to look at women who are on immune-weakening medications like Skyrizi [risankizumab] for skin conditions like psoriasis. These are commonly used in young people and can increase the risk of cervical cancer. I haven’t seen a lot of conversation about this, but patients should be aware of this risk and recommendations for this group should be different than for the general population.”

The USPSTF also noted a need to assess the magnitude of the incremental benefit and harms of screening and the interval of multiple rounds of HPV-primary screening in HPV-vaccinated cohorts in US populations.

Davis, Aviles, and Zahn and had no relevant competing interests to disclose.
 

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

The US Preventive Services Task Force (USPSTF) has posted a draft updated statement on cervical cancer screening. The statement is open for public comment until January 13, 2025, on the task force’s website. 

Nearly all cases of cervical cancer are caused by human papilloma virus (HPV) and most occur in women who have not been regularly screened or appropriately treated, the task force stressed.
 

New Screening Option

In 2024, there will be an estimated 13,820 new cases of cervical cancer and 4360 deaths.

“Evidence shows that screening saves lives, and all women aged 21-65 need to be screened,” task force member Esa Davis, MD, MPH, FAAFP, a professor of family and community medicine and associate vice president for community health at the University of Maryland, Baltimore, said in an interview. A new feature in the 2024 draft statement endorsing self-collection of cervical samples for HPV testing may facilitate broader screening. 

“We hope the new effective option of self-collecting will expand screening and allow even more women to get screened regularly,” Davis said. “Some may feel more comfortable collecting samples themselves, and the collection can be office-based or home-based, but it’s very important that it be done under the direction of a clinician.” 

In agreement is Diego Aviles, MD, an assistant professor and a gynecologic oncologist with UTHealth Houston. “Self-collection will absolutely expand screening. I think it’s an incredible advancement in medicine that patients are able to collect in the comfort of their own homes with no need to come into the office for an uncomfortable pelvic exam,” he said in an interview. “This empowers the patient and gives her a choice.”

As to concern about potential error, he added that while this is a concern on paper, “a lot of studies have shown that self-collection is just as effective doctor collection.” 

Largely consistent with the task force’s 2018 screening recommendations, the updated suggestions also align with those of other organizations such as the American College of Obstetricians and Gynecologists (ACOG), Davis said.

Christopher M. Zahn, MD, ACOG’s chief of clinical practice and health equity and quality, stressed the importance of cervical cancer screening and said his organization will be reviewing the USPSTF recommendations. He urges ACOG members to consider them and offer their comments on the public-input platform.

Drawing on the latest evidence, the task force is also highlighting for the first time that stand-alone HPV screening gives women aged 30-65 years the best balance of benefits and harms when it comes to finding and preventing cervical cancer, while continuing to reinforce that Pap testing and co-testing are also effective screening options for these women. 

The current draft statement applies to cisgender women and those assigned female sex at birth, including transgender men and nonbinary individuals. The recommendations do not apply to women at increased risk of cervical cancer such as those with HIV infection, a compromised immune system, or a history of treatment for precancerous lesions or cervical cancer. 

Based on a review of evidence on the benefits and harms of screening, the USPSTF’s independent panel of national experts proposed the following:
 

Recommendations for Screening (Based on Grade A Evidence):

  • Ages 21-65 years: All women should get screened regularly for this preventable disease.
  • Ages 21-29 years: All women in this age group should undergo a Pap test every 3 years but do not need HPV testing. “In this age group most HPV infections will go away on their own because young women have strong immune systems. Older women are likely to have HPV that lasts longer and so they need testing for the virus,” Davis said.
  • Ages 30-65 years: As noted, HPV screening gives women in this age category the best balance of benefits and harms in terms of preventing and finding cervical cancer. Pap testing or co-testing (Pap tests and HPV tests) are also effective screening options for this population. Ideally, these women should have an HPV test every 5 years or, alternatively, a Pap test every 3 years, or a combined HPV and Pap test every 5 years (co-testing).

Recommendations Against Screening (No Benefit or Benefit Outweighed by Harms — Grade D evidence):

  • Women aged less than 21 years: Screening is not necessary.
  • Other women not needing screening: Nor is screening necessary for those of any age who have had a total hysterectomy with removal of the cervix and those aged > 65 years who have had regular screenings with normal results. That means normal results from their last three Pap tests or their last two HPV tests, completed in the past 10 years, with at least one of the tests done in the past 5 years.
  • Women aged 65 or more: These women should continue screening only if they have not been screened regularly or have had abnormal results in the past decade such as a high-grade precancerous lesion (cervical intraepithelial neoplasia grade 2 or 3) or cervical cancer.

Davis noted that none of the current recommendations are likely to be controversial or to spark pushback. “But,” said Aviles, “any time I see recent change in medicine, there’s always a little bit of pushback and it may take some time for everyone to be comfortable with the self-collection option. The recommendations still give doctors the grace to use the screening test they feel comfortable with, but I think eventually everyone will get on board with self-collection.”

As for the future, he added, “Over the next few years we’ll have to look at women who are on immune-weakening medications like Skyrizi [risankizumab] for skin conditions like psoriasis. These are commonly used in young people and can increase the risk of cervical cancer. I haven’t seen a lot of conversation about this, but patients should be aware of this risk and recommendations for this group should be different than for the general population.”

The USPSTF also noted a need to assess the magnitude of the incremental benefit and harms of screening and the interval of multiple rounds of HPV-primary screening in HPV-vaccinated cohorts in US populations.

Davis, Aviles, and Zahn and had no relevant competing interests to disclose.
 

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Un-Gate On Date
Use ProPublica
CFC Schedule Remove Status
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date

Alcohol: How Much Is Too Much?

Article Type
Changed

A 40-year-old woman presents for a wellness visit. She says that she feels well but admits to high levels of stress and occasional fatigue. She works about 60 hours per week as an executive in a finance company. In addition, she is married and has two children, ages 12 and 10 years. She says that she has no time for herself and has noticed that she gets frustrated faster than she used to, but she does not think she has depression. Her score on a Patient Health Questionnaire 9 (PHQ-9) is 5, indicating a low level of depression symptoms.

Regarding health habits, she has never used nicotine products. She reports having one to two alcoholic drinks per day, either wine or a cocktail, and has four drinks per day on a couple of weekend days per month (such as on “date night” with her spouse). She says she does not use any other drugs, including cannabis, and is not taking any medications.

Her vital signs and physical examination are unremarkable. You note that she had an evaluation with a complete blood count, comprehensive metabolic panel, and thyroid-stimulating hormone level performed 7 months ago, with normal results.

What would be the best next step in caring for this patient?

A. Ask her to consider talk therapy to address her fatigue and stress

B. Have her complete a tool (such as the AUDIT-C) to identify hazardous drinking

C. Consider prescribing a selective serotonin reuptake inhibitor

D. Repeat her previous labs, adding vitamin B12 and vitamin D levels

Dr. Vega’s Take

Although all of the answer choices above could apply to this patient, a more formal screening for problem drinking is the most important intervention to make now.

This patient’s story is not unique, particularly in the wake of the COVID-19 pandemic. According to data from the National Institute on Alcohol Abuse and Alcoholism, 64% and 61% of males and females, respectively, at least 12 years of age, reported consuming alcohol in 2023, and 21.7% of these individuals reported binge drinking. 

Alcohol consumption is taking an increasing toll on public health. Between 2016 and 2021, the number of US deaths caused by excessive alcohol use increased by 29%, to a total of 47.6 cases per 100,000 population. The death rate increased faster among females vs males.

The US Preventive Services Task Force (USPSTF) recommends screening for alcohol misuse among adults at least 18 years of age, with no specific interval for repeat screening. USPSTF does recommend two specific screening instruments because of their ease of use and accuracy: the Alcohol Use Disorders Identification Test–Consumption (AUDIT-C) and Single Alcohol Screening Question (SASQ): How many times in the past year have you had more than four drinks (for women) or five drinks (for men) in a day? 

The AUDIT-C features three questions about alcohol use, the amount of alcohol consumed, and the frequency of heavy alcohol use. The instrument is scored from 0 to 12, with a higher score indicating a high risk for problem drinking. Generally, an AUDIT-C score is considered a positive screen at a score of 4 for men and 3 for women. The SASQ focuses on the number of heavy drinking days in the past year, with a current cutoff of five drinks for men and four drinks for women and anyone age 65 years or older.

Both the AUDIT-C and SASQ should be followed up with a more extensive history to make the diagnosis of alcohol use disorder (AUD). The USPSTF also recommends at least brief follow-up counseling for adults with possible AUD, noting that the most common form of counseling is personalized normative feedback, which compares a patient’s alcohol use pattern with that of others. 

What is your practice in screening for AUD, and what have you found effective in counseling patients? I look forward to hearing your thoughts.

Dr. Vega is Health Sciences Clinical Professor, Family Medicine, University of California, Irvine. He reported a conflict of interest with McNeil Pharmaceuticals.

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

Publications
Topics
Sections

A 40-year-old woman presents for a wellness visit. She says that she feels well but admits to high levels of stress and occasional fatigue. She works about 60 hours per week as an executive in a finance company. In addition, she is married and has two children, ages 12 and 10 years. She says that she has no time for herself and has noticed that she gets frustrated faster than she used to, but she does not think she has depression. Her score on a Patient Health Questionnaire 9 (PHQ-9) is 5, indicating a low level of depression symptoms.

Regarding health habits, she has never used nicotine products. She reports having one to two alcoholic drinks per day, either wine or a cocktail, and has four drinks per day on a couple of weekend days per month (such as on “date night” with her spouse). She says she does not use any other drugs, including cannabis, and is not taking any medications.

Her vital signs and physical examination are unremarkable. You note that she had an evaluation with a complete blood count, comprehensive metabolic panel, and thyroid-stimulating hormone level performed 7 months ago, with normal results.

What would be the best next step in caring for this patient?

A. Ask her to consider talk therapy to address her fatigue and stress

B. Have her complete a tool (such as the AUDIT-C) to identify hazardous drinking

C. Consider prescribing a selective serotonin reuptake inhibitor

D. Repeat her previous labs, adding vitamin B12 and vitamin D levels

Dr. Vega’s Take

Although all of the answer choices above could apply to this patient, a more formal screening for problem drinking is the most important intervention to make now.

This patient’s story is not unique, particularly in the wake of the COVID-19 pandemic. According to data from the National Institute on Alcohol Abuse and Alcoholism, 64% and 61% of males and females, respectively, at least 12 years of age, reported consuming alcohol in 2023, and 21.7% of these individuals reported binge drinking. 

Alcohol consumption is taking an increasing toll on public health. Between 2016 and 2021, the number of US deaths caused by excessive alcohol use increased by 29%, to a total of 47.6 cases per 100,000 population. The death rate increased faster among females vs males.

The US Preventive Services Task Force (USPSTF) recommends screening for alcohol misuse among adults at least 18 years of age, with no specific interval for repeat screening. USPSTF does recommend two specific screening instruments because of their ease of use and accuracy: the Alcohol Use Disorders Identification Test–Consumption (AUDIT-C) and Single Alcohol Screening Question (SASQ): How many times in the past year have you had more than four drinks (for women) or five drinks (for men) in a day? 

The AUDIT-C features three questions about alcohol use, the amount of alcohol consumed, and the frequency of heavy alcohol use. The instrument is scored from 0 to 12, with a higher score indicating a high risk for problem drinking. Generally, an AUDIT-C score is considered a positive screen at a score of 4 for men and 3 for women. The SASQ focuses on the number of heavy drinking days in the past year, with a current cutoff of five drinks for men and four drinks for women and anyone age 65 years or older.

Both the AUDIT-C and SASQ should be followed up with a more extensive history to make the diagnosis of alcohol use disorder (AUD). The USPSTF also recommends at least brief follow-up counseling for adults with possible AUD, noting that the most common form of counseling is personalized normative feedback, which compares a patient’s alcohol use pattern with that of others. 

What is your practice in screening for AUD, and what have you found effective in counseling patients? I look forward to hearing your thoughts.

Dr. Vega is Health Sciences Clinical Professor, Family Medicine, University of California, Irvine. He reported a conflict of interest with McNeil Pharmaceuticals.

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

A 40-year-old woman presents for a wellness visit. She says that she feels well but admits to high levels of stress and occasional fatigue. She works about 60 hours per week as an executive in a finance company. In addition, she is married and has two children, ages 12 and 10 years. She says that she has no time for herself and has noticed that she gets frustrated faster than she used to, but she does not think she has depression. Her score on a Patient Health Questionnaire 9 (PHQ-9) is 5, indicating a low level of depression symptoms.

Regarding health habits, she has never used nicotine products. She reports having one to two alcoholic drinks per day, either wine or a cocktail, and has four drinks per day on a couple of weekend days per month (such as on “date night” with her spouse). She says she does not use any other drugs, including cannabis, and is not taking any medications.

Her vital signs and physical examination are unremarkable. You note that she had an evaluation with a complete blood count, comprehensive metabolic panel, and thyroid-stimulating hormone level performed 7 months ago, with normal results.

What would be the best next step in caring for this patient?

A. Ask her to consider talk therapy to address her fatigue and stress

B. Have her complete a tool (such as the AUDIT-C) to identify hazardous drinking

C. Consider prescribing a selective serotonin reuptake inhibitor

D. Repeat her previous labs, adding vitamin B12 and vitamin D levels

Dr. Vega’s Take

Although all of the answer choices above could apply to this patient, a more formal screening for problem drinking is the most important intervention to make now.

This patient’s story is not unique, particularly in the wake of the COVID-19 pandemic. According to data from the National Institute on Alcohol Abuse and Alcoholism, 64% and 61% of males and females, respectively, at least 12 years of age, reported consuming alcohol in 2023, and 21.7% of these individuals reported binge drinking. 

Alcohol consumption is taking an increasing toll on public health. Between 2016 and 2021, the number of US deaths caused by excessive alcohol use increased by 29%, to a total of 47.6 cases per 100,000 population. The death rate increased faster among females vs males.

The US Preventive Services Task Force (USPSTF) recommends screening for alcohol misuse among adults at least 18 years of age, with no specific interval for repeat screening. USPSTF does recommend two specific screening instruments because of their ease of use and accuracy: the Alcohol Use Disorders Identification Test–Consumption (AUDIT-C) and Single Alcohol Screening Question (SASQ): How many times in the past year have you had more than four drinks (for women) or five drinks (for men) in a day? 

The AUDIT-C features three questions about alcohol use, the amount of alcohol consumed, and the frequency of heavy alcohol use. The instrument is scored from 0 to 12, with a higher score indicating a high risk for problem drinking. Generally, an AUDIT-C score is considered a positive screen at a score of 4 for men and 3 for women. The SASQ focuses on the number of heavy drinking days in the past year, with a current cutoff of five drinks for men and four drinks for women and anyone age 65 years or older.

Both the AUDIT-C and SASQ should be followed up with a more extensive history to make the diagnosis of alcohol use disorder (AUD). The USPSTF also recommends at least brief follow-up counseling for adults with possible AUD, noting that the most common form of counseling is personalized normative feedback, which compares a patient’s alcohol use pattern with that of others. 

What is your practice in screening for AUD, and what have you found effective in counseling patients? I look forward to hearing your thoughts.

Dr. Vega is Health Sciences Clinical Professor, Family Medicine, University of California, Irvine. He reported a conflict of interest with McNeil Pharmaceuticals.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Un-Gate On Date
Use ProPublica
CFC Schedule Remove Status
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date

Freezing the Pain: A New Way to Treat Rib Fractures

Article Type
Changed

This transcript has been edited for clarity. 

Robert D. Glatter, MD: Hi. I’m Dr. Robert Glatter, medical advisor for Medscape Emergency Medicine. Joining me today to discuss a novel way to treat pain related to conditions such as rib fractures and burns is Dr. Sergey Motov, an emergency physician with expertise in pain management and research director in the Department of Emergency Medicine at Maimonides Medical Center in Brooklyn, New York.

Also joining me is Dr. Gary Schwartz, vice chair of pain and anesthesiology at Maimonides Medical Center. Dr. Schwartz is board certified in anesthesiology and interventional pain management. 

Welcome, Sergey and Gary. 

Sergey M. Motov, MD: Thank you, Robert. 

Gary S. Schwartz, MD: Thank you, Robert. 

 

Traditional Approaches to Pain Relief

Glatter: It’s a pleasure to have you both. Sergey, we were chatting earlier this week and you had mentioned a novel approach to treating a common condition we encounter in the emergency department — rib fractures.

As we all know, they’re very painful and can lead to pulmonary complications, including atelectasis, pneumonia due to splinting and lack of proper pain management, along with the use of incentive spirometry.

Sergey and Gary, can you describe traditional approaches to alleviating the pain associated with rib fractures? What do we typically use? Then we’ll get to some novel treatments that we’re here to discuss.

Motov: I’m going to use the emergency medicine approach to rib fractures. As you pointed out, pain relief is of utmost importance.

With the advent and acquiring of the amazing technique of interventional pain management, physicians, for the most part, are very astute about providing nerve blocks to alleviate pain, at least in immediate need. I’m talking about the relatively short term, 1-5 hours, in the emergency department.

Primarily, we focus on fascial plane blocks such as serratus anterior plane block. Traditionally, ED physicians don’t use much of the intercostal blocks. At times, we can direct the spinal block to cover the lateral aspect of the chest wall. 

As part of the multimodal approach, we can use NSAIDs. If there’s a contraindication, we can use opioids. There are some data to support consideration of using topical formularies such as a lidocaine patch, but they are somewhat conflicting. 

The question becomes what you’re going to send a patient home with. Again, traditional teaching is either opioids, immediate release with a short course, plus or minus NSAIDs, plus or minus acetaminophen.

The issue with rib fractures is that, while we can manage immediate and super-acute pain presentation in the ED and then discharge up to 24-72 hours, what happens afterwards is very challenging. Acute intercostal neuralgia related to traumatic rib fractures is semi-manageable, but if it’s inappropriately treated, it has a great tendency to transform into chronic intercostal neuralgia. It contributes a great deal of disability and morbidity. 

Several years ago, I came across an entity called cryoneurolysis (cryo ─ cold temperature; neurolysis ─ freezing the nerve). I’m excited to be here today because Gary is the one who’s pioneering and championing this technique in our institution. 

 

Cryoneurolysis: Mechanisms of Action and Benefits

Glatter: Gary, what do you see as the main role for this procedure at this time? 

Schwartz: As Sergey alluded to, the traditional approach of opiates has side effects (ie, constipation, addiction, and tolerance). Unfortunately, many of these rib fractures occur in older patients. They come in anticoagulated, so they can’t have NSAIDs. 

Sergey and his team in the ER have been pioneers in giving short-acting local anesthetic blocks that could last anywhere from 12 to 24 hours. There are long-acting local anesthetics that we can get out to 72 hours.

Unfortunately, these rib fractures and the pain associated with them, in addition to the intercostal neuralgia, could take weeks to heal. That’s where cryoneurolysis comes in. We’re all used to ice or cold temperature. For example, if your child gets an ear piercing, they put some ice on their earlobe beforehand, it numbs it up, and they don’t feel pain. It allows them to get their ears pierced without pain, but it’s short-acting. 

What we have now are handheld devices with tips about as long as a pen, 3.5 inches, that allow you to go down precisely to these intercostal nerves that innervate the ribs and give a cold lesion that freezes these nerves. 

The benefit of it is it’s not permanent like cryoablation, like we’ve seen for tumor necrosis, which destroys outside tissues. It’s really a small lesion, about 16 mm x 8 mm, which is enough to engulf the nerve and pretty much stun it. 

It causes axonotmesis, but the epineurium, the endoneurium, and the perineurium — the inner workings of the nerve — stay intact, so it regrows. It just destroys the myelin sheath and the axon.

Glatter: You’re creating a scarring effect; is that what you’re saying? In other words, you’re doing a cold-temperature freeze and stunning the nerve. My question is, does it regrow? Is this a permanent type of injury? 

Schwartz: With Wallerian degeneration, nerves do regrow after injuries.

Unfortunately, as you two probably see in the ER for big traumas, where the nerve is transected, those unfortunately do not grow back. This is considered a grade 2 lesion, so the Wallerian degeneration recurs. The nerves grow, depending on the literature you look at, about 0.5-2 mm per day.

This intervention gives us at least 3 months of relief for the patient, which is in the time frame where the rib fracture will heal, hopefully with no damage to the nerve from the fracture, and they go on living their life without having to take opiates or having to stop their anticoagulation. 

Because prior to this, when I was a pain fellow, we used to put epidurals in many of these patients. The problem with that is patients can’t go home, and if they’re anticoagulated, you can’t place it because of the risk of a spinal hematoma. 

 

Potential Use in Ventilation Weaning

Glatter: This is something we encounter daily, and certainly for those patients who have more numerous rib fractures or flail chest, this could be even more devastating, as well as for those who get intubated.

Do you see any role, in terms of ventilator weaning, in using this technique specifically in the ICU setting? 

Schwartz: That’s an interesting concept. I’m not so sure about ventilator weaning, but we’ve used this in the hospital for rib fractures from traumas where patients had such severe fractures and had to go to the operating room for rib plating, and did necessitate an epidural. We’ve used this to discontinue their epidural and transition them to get the patient home. 

I think that is part of the care, not only in the ER but in the hospital as well. We need to treat the patients, but we also have to have a transition plan to get them out of the hospital. Not that we don’t want to treat our patients, but we have to have a plan to get them home. I’m guessing that might be an interesting stage of research in the future if it does help with weaning from a ventilator. 

Glatter: There are some studies out there suggesting that there can be some utility in terms of ventilator weaning using this technique. The ability of this to change how we manage pain is just incredible.

Sergey, do you feel that this is something that you could implement in your ED with your patients in the near future? 

Motov: Definitely. I have personally been a very big proponent of it. I’m the theoreticist because I’ve covered a great deal of literature, and now having Gary and his team doing this in our institution, it’s a shame not to capitalize on it. I’m slowly moving toward figuring out the way of collaborative effort to have Gary and his team help my team and our colleagues, bring him on board, and maybe broaden the integration for pain management.

I believe, as Gary emphasized, that geriatric traumatic pain injuries are critically important due to the presence of comorbidities, potential drug interactions, and the challenges of managing these factors effectively.

There is one thing I want to bring up, and Gary, please support me on it. The procedure itself is fascinating because it provides long-term pain relief and reduces morbidity. I wouldn’t say mortality, just reduced morbidity. However, we need to be very conscious of the fact that this blockade, this ice-ball freezing of the nerve, can be detrimental to motor nerves. If your whole goal or idea of faster recovery after postoperative knee or hip replacements, or any traumatic lower- or upper-extremity surgery, includes blockade of motor nerves, it’s not going to be beneficial.

I believe the primary therapeutic application of this technology lies in targeting sensory nerves. For instance, intercostal nerves could be a focus in cases of rib fractures. Additionally, this approach shows promise for treating burns, particularly in the lower and upper extremities. Specifically, targeting nerves such as the lateral femoral cutaneous nerve or the anterior femoral cutaneous nerve could effectively neutralize pain and provide significant relief for weeks, if not months.

Based on additional predilection to what particular indications would be, maybe occipital headache with cervicalgia, occipital nerve block — it’s a sensory block — can benefit from it. Slowly but surely, there’s a slew of painful syndromes for which cryoneurolysis might have a great deal of use in the emergency department.

 

Cryoneurolysis for Other Pain Syndromes

Glatter: Gary, I’ll let you expand upon additional uses that you see. You did mention one on our chat earlier this week, which was postmastectomy pain syndrome with the intercostal brachial nerve. That’s a very compelling area of interest, certainly for the number of women that go through mastectomies or lumpectomies and that have axillary dissection or nerve injury.

Schwartz: Post-mastectomy is one way you could use this device and technology to attack painful syndromes, such as postmastectomy syndrome. Mastectomies are one of the most common surgeries performed in the United States, but I believe it’s a top three for post-op chronic pain, which we don’t normally think of. 

There was a great study by a team in San Diego where they did intercostal brachial and intercostal nerve blocks on multiple nerves, and they decreased pain up to 3 months after the surgery and decreased opiates. 

As Sergey alluded to, it’s approved for any peripheral nerve in the body. We’ve used it in our pain office for occipital neuralgia, postherpetic neuralgia, chronic rib pain after fractures, and surgery. Some of the most common uses are for superficial, sensory, genicular nerves, the lateral femoral cutaneous nerve, the anterior femoral cutaneous nerve, and the infrapatellar branch of the saphenous.

You could numb the skin preoperatively before a painful surgery, such as a total knee replacement — or as we like to call it, a total knee arthroplasty — to reduce opiates, improve function, and decrease length of stay. You could attack any sensory nerve.

We’ve utilized that already in our private practice. We’re trying to transition into the hospital to have everyone who gets a knee arthroplasty have this technology to decrease opiates, improve function, and recover faster. 

This is quite interesting and motivating for me because when I first started, we had a femoral catheter to block the motor femoral nerve or an epidural. Patients were in the hospital for 3-5 days with the CPM [continuous passive motion] machine, which is like a medieval torture device that you might see in Mad Max — where you’re kind of moving the patient’s knee back and forth after surgery, and they were miserable, taking patient-controlled analgesia and high-dose opiates. Now, we’re freezing these nerves beforehand, doing our nerve blocks in the operating room with long-acting local anesthetic, and patients are going home the same day with minimal or even no opiates sometimes.

 

Implications for Patient Mobility and DVT Risk

Glatter: You’re getting up to 3 months of relief in that setting, doing it as you described?

Schwartz: Yes, up to 3 months of relief, which is huge, because most patients recovering from a knee arthroplasty, at about the 6- to 8-week mark, have improved range of motion, they have their 110° flexion, they have their extension, and they’re getting back to their normal life.

You cover the whole postoperative rehab, where patients don’t have to get recurring refills, they can participate in physical therapy. As you both know, part of the recovery process is to be able to interact with family and friends without being sleepy, angry, and in pain all day, so they can get back to their normal function.

Glatter: In terms of this procedure, would there be any increase in deep vein thrombosis (DVT) in relation to this, by chance? 

Schwartz: Actually, there’s less of a risk of DVT because patients have less pain, so they can get up and move faster. Some of my surgical colleagues who have implemented this in their practice have gotten away from using the stronger anticoagulation like Xarelto (rivaroxaban) or Coumadin (warfarin), and they just give them baby aspirin postoperatively because their patients are going home the same day and walking. It’s probably safer for patients. There’s no research out there yet to show that, but we all know that the more you move and the more you’re not lying around, the lower the risk of having a DVT or a blood clot. 

There are studies showing that there’s no damage to blood vessels, other than if you stick it with the needle, because the nitrogen gas in this that allows the ice ball to form does not get injected into the body. It’s all resorbed in the machine. The only thing the body sees is this ice ball, which would melt if you hit a blood vessel because we should be 98 °F and the ice ball is -88 °F. There’s no gas injected into the body either, so there’s no risk of a gas embolism. 

 

Training and Implementation

Glatter: I was going to ask you about air emboli, and you perfectly led right into that. 

In terms of training requirements, currently, what do you envision as a way we can train residents and fellows to do this? Is this currently something being considered in curriculum? 

Schwartz: We are going to train our residents first. I’m training the attendings. Before you use this technology, you should have a basic understanding of ultrasound, how to use the device, the different settings, and what the risks are for each procedure you’re doing. 

Let’s say, as Sergey alluded to, with an intercostal nerve block, you could have a pneumothorax. You have to be able to identify the rib, where the nerve should lie, the innermost intercostal muscle you could see on the newer ultrasounds, and where the pleura lies. People should start with just basic ultrasound training and then advance to a typical intercostal nerve block.

Once you master that, the procedure with the device is not much different than an intercostal nerve block, except you have a handheld device and the needle is just as long as a pen, 3.5 inches.

If you could do a nerve block with a spinal needle, you could do the procedure. Once people have the technical ultrasound skills, then they can advance to needle-based procedures, and once you have that training, you could use this procedure safely and efficaciously. 

Glatter: Sergey, do you see this as requiring quite a bit of time and training in your program?

Motov: I mentioned earlier, before we started, that with the advent of ultrasound-guided nerve blocks, the vast majority of physicians are becoming very comfortable and fairly effective with maneuvering a needle and the ultrasound probe. The learning curve is essentially the same. The only difference is, as Gary pointed out, some of the nerves could be new to ED folks, but the technique, the understanding, the visualization, and the knowledge of anatomy are essentially the same. 

As he pointed out, if you can use it with a spinal needle and local anesthetic, the procedure becomes exactly the same. It’s a slightly different drug and a different needle, and instead of local anesthetic, you’re using a gas at cold temperatures, and that’s pretty much it. 

Glatter: Are there any other barriers to adoption in terms of cost, the device itself, or the companies that manufacture these handheld devices?

Schwartz: There’s always cost associated with the new device, needles, and the gas. Thankfully, they’re covered by Medicare, Medicaid, and most commercial insurances in the current framework, which I think is important. I think Congress is seeing the benefits of opiate sparing that Sergey helped lead in the ED.

At AABP Integrative Pain Care and Wellness and Maimonides, we’re doing this intraoperatively as well. I think the government is seeing that. There was a NOPAIN Act passed in 2023 that, starting January 1, 2025, will allow certain approved companies, devices, and medications to have to be repaid by CMS, Centers for Medicare & Medicaid Services, in the hospital setting and in the outpatient departments. In the inpatient surgical stays, we could have less opiates. I think that’s important. It is reimbursed now. Obviously, there is a cost associated. 

The other benefit of this procedure and these techniques is, as Sergey alluded to, it’s done under ultrasound. The way we all learn procedures, whether it be central lines or chest tubes, is the blind technique. There is no good way to practice. In my interventional pain practice, many of our original techniques were done under fluoroscopy, and we don’t want to get extra radiation during practice. 

The benefit of ultrasound and the advent of handheld ultrasound devices is that we can practice scanning and techniques on ourselves and on colleagues, without the fear of radiation. Other than the fact that we need to shower after the surgical lube is on from the scanning gel, you could practice your techniques in a safe way without harming a patient or yourself. 

 

Future Directions in Pain Management Techniques

Glatter: Absolutely. Do you see any role for possibly stellate ganglion blocks, which are a bit riskier and have greater depth?

Schwartz: People are looking at different studies because, again, it’s a needle-based technology. We do many stellate ganglion blocks. I have not done it for this procedure yet, but that’s the next step of what I try. Under ultrasound, we could see the longus colli muscle and we could see the carotid artery. Obviously, we don’t see the ganglion per se, but anatomically, we know where it lies. You could drop a couple of lesions on there and give a theoretic prolonged sympathetic block, which might help with symptoms of complex regional pain syndrome

I know there are some studies that have looked at stellate ganglion blocks for long-COVID symptoms. Unfortunately, it looks like we’re back in another wave right now. I think that’s the next step of the technology. 

Glatter: Getting back to the emergency department, burns are something we see commonly — such painful conditions. This is something that could really provide significant relief, especially with burns that involve the chest wall, not just extremity burns.

Motov: I agree with you. Burns would be a very good indication to utilize this technique. Just listening to you and Gary, another thing that pops into my head, which may have actually some science behind it, would be any traumatic amputations done in a civilian environment or even in the military in a combat situation.

A person who has either an upper or lower extremity that is partially or completely severed or amputated, and the pain — God knows how bad it is — if not properly treated, it is going to be a very long recovery. That’s, I believe, another percutaneous condition where cryoneurolysis will be very beneficial to freeze those nerves, allowing patients to recover through rehab acute care, acute phases, rehabilitation, and move on with their lives. 

Glatter: In the setting of a painful distal radius fracture, a femur fracture, and things of that nature, Gary, do you see this as a modality in conjunction with emergency medicine colleagues as being something that’s going to really become an important part of our armamentarium?

Schwartz: I do think it’s going to become more important in the future, as there are more studies to show what nerves you could block with cryoneurolysis in the longer term. I think you might see people start using these for fractures, especially for fractures that are not operable at the time or if a patient needs to be optimized prior to surgery.

As Sergey alluded to, it’s optimal in burns. People have been looking for relief of stump pain or postamputation pain. There’s a big researcher in Canada who’s been looking at pain with spasticity for people with cerebral palsy and poststroke issues, where they can’t move and they have pain moving an extremity after these conditions. We’re at just the tip of the iceberg as to where people are going to use this hand-held technology in the future. 

Glatter: We use long-acting nerve blocks for hip fractures already in the emergency department. Why not employ this technique, which would have longer effects and limit opiate use?

Schwartz: It might even help a certain subset of the population, at least in Brooklyn, where we have a large elderly population. I believe it’s one of the oldest boroughs in the country, and definitely in New York. 

There are some people that go on to surgery just because they might be bedbound, but it’s the pain that is dictating their surgical procedure, not that they’re ever going to walk again.

It’s maybe the next step to look for. If you could block this nerve for 3 months or longer, they’re still going to be bedbound, but maybe you could avoid a surgical procedure that carries its own morbidity and mortality, which I see a big interest in in the future. 

Glatter: Absolutely. The idea behind treating spasticity is very important from an occupational therapy standpoint — eating, activities of daily living — just the basics.

Getting someone’s fingers released, being able to move their legs again, and getting them out of contracture states, I think, has a huge role. 

Schwartz: Not only for the patient but also for the caregivers. For many of these patients, if they’re contracted fully and the pain from the spasticity is preventing their caregivers from moving them, it’s difficult to put on a shirt, pants, and so on.

One other point I’d like to make is that it’s reproducible. It’s not one-and-done. If the pain comes back from any of these conditions, you could treat again with another cryoneurolysis treatment. The current literature to date shows that it’s just as effective time and time again. I’ve seen clinically that you can repeat this procedure, whereas some of our other procedures that we do in medicine are not as reproducible, which is important for some of these chronic conditions.

Glatter: You had mentioned reimbursement earlier. Currently, this procedure is reimbursed under Medicare, Medicaid, and third-party payers, I assume? 

Schwartz: Not all, but many commercial insurers. Yes for Medicare. 

 

Final Takeaways

Glatter: Reimbursement has to be really universal because if this is shown to be more effective and limits opiate use, then there’s no question in my mind that this is such a groundbreaking procedure.

I’ll let you both give a few pearls for our audience to summarize our discussion.

Motov: I’d say it’s somewhat long overdue that this technique and pain-relieving modality should enter the emergency department, with the auspices and the beautiful collaborative effort between emergency department folks and interventional anesthesiologists, pain management specialists, collaborative training, and a collaborative goal of improving patients’ pain throughout the entire journey during the healthcare system.

That would be my only pearl. Just reach out to your colleagues within your respective institutions who you believe have aptitude, knowledge, and expertise. Reach out, get trained, and start passing down the knowledge to your faculty, and by virtue of extension, to your fellow residents and colleagues.

Schwartz: He took the words right out of my mouth. Communication and collaboration are the two most important things. There’s a shortage of physicians in this country. We can only each do so much, so we should each utilize and implement this technology to affect and help as many patients as possible.

We can decrease the amount of opiates, help our patients, help our family members in our community live with decreased pain, improve their function, and just get back to their lives and keep pushing the envelope of what’s the next step in treatment.

Again, like we went from giving opiates for this and that’s it — maybe an epidural, maybe a 5- to 6-hour intercostal nerve block — to fascial plane blocks like Sergey said, to more advanced procedures, to now we can give months of relief. 

I think the communication, the collaboration, and the camaraderie among our different specialties are important to push the envelope to help our patients. 

Glatter: That’s so well put. I completely agree. 

I want to thank both of you for a very lively discussion. It was very informative. Your expertise is greatly appreciated and will certainly benefit our audience. Thank you both again.

Dr. Glatter is an assistant professor of emergency medicine at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. Dr. Motov is professor of emergency medicine and director of research in the Department of Emergency Medicine at Maimonides Medical Center in Brooklyn, New York. Dr. Schwartz is co-owner and primary clinic director at AABP Integrative Pain Care in Brooklyn, New York. Schwartz currently serves as the co-director of AABP Integrative Pain Care and Wellness and the vice chair of pain and anesthesiology for Maimonides Medical Center. Dr. Schwartz reported conflicts of interest with Pacira Biosciences and Dorsal Health; neither Dr. Glatter nor Dr. Motov reported relevant conflicts of interest.

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

Publications
Topics
Sections

This transcript has been edited for clarity. 

Robert D. Glatter, MD: Hi. I’m Dr. Robert Glatter, medical advisor for Medscape Emergency Medicine. Joining me today to discuss a novel way to treat pain related to conditions such as rib fractures and burns is Dr. Sergey Motov, an emergency physician with expertise in pain management and research director in the Department of Emergency Medicine at Maimonides Medical Center in Brooklyn, New York.

Also joining me is Dr. Gary Schwartz, vice chair of pain and anesthesiology at Maimonides Medical Center. Dr. Schwartz is board certified in anesthesiology and interventional pain management. 

Welcome, Sergey and Gary. 

Sergey M. Motov, MD: Thank you, Robert. 

Gary S. Schwartz, MD: Thank you, Robert. 

 

Traditional Approaches to Pain Relief

Glatter: It’s a pleasure to have you both. Sergey, we were chatting earlier this week and you had mentioned a novel approach to treating a common condition we encounter in the emergency department — rib fractures.

As we all know, they’re very painful and can lead to pulmonary complications, including atelectasis, pneumonia due to splinting and lack of proper pain management, along with the use of incentive spirometry.

Sergey and Gary, can you describe traditional approaches to alleviating the pain associated with rib fractures? What do we typically use? Then we’ll get to some novel treatments that we’re here to discuss.

Motov: I’m going to use the emergency medicine approach to rib fractures. As you pointed out, pain relief is of utmost importance.

With the advent and acquiring of the amazing technique of interventional pain management, physicians, for the most part, are very astute about providing nerve blocks to alleviate pain, at least in immediate need. I’m talking about the relatively short term, 1-5 hours, in the emergency department.

Primarily, we focus on fascial plane blocks such as serratus anterior plane block. Traditionally, ED physicians don’t use much of the intercostal blocks. At times, we can direct the spinal block to cover the lateral aspect of the chest wall. 

As part of the multimodal approach, we can use NSAIDs. If there’s a contraindication, we can use opioids. There are some data to support consideration of using topical formularies such as a lidocaine patch, but they are somewhat conflicting. 

The question becomes what you’re going to send a patient home with. Again, traditional teaching is either opioids, immediate release with a short course, plus or minus NSAIDs, plus or minus acetaminophen.

The issue with rib fractures is that, while we can manage immediate and super-acute pain presentation in the ED and then discharge up to 24-72 hours, what happens afterwards is very challenging. Acute intercostal neuralgia related to traumatic rib fractures is semi-manageable, but if it’s inappropriately treated, it has a great tendency to transform into chronic intercostal neuralgia. It contributes a great deal of disability and morbidity. 

Several years ago, I came across an entity called cryoneurolysis (cryo ─ cold temperature; neurolysis ─ freezing the nerve). I’m excited to be here today because Gary is the one who’s pioneering and championing this technique in our institution. 

 

Cryoneurolysis: Mechanisms of Action and Benefits

Glatter: Gary, what do you see as the main role for this procedure at this time? 

Schwartz: As Sergey alluded to, the traditional approach of opiates has side effects (ie, constipation, addiction, and tolerance). Unfortunately, many of these rib fractures occur in older patients. They come in anticoagulated, so they can’t have NSAIDs. 

Sergey and his team in the ER have been pioneers in giving short-acting local anesthetic blocks that could last anywhere from 12 to 24 hours. There are long-acting local anesthetics that we can get out to 72 hours.

Unfortunately, these rib fractures and the pain associated with them, in addition to the intercostal neuralgia, could take weeks to heal. That’s where cryoneurolysis comes in. We’re all used to ice or cold temperature. For example, if your child gets an ear piercing, they put some ice on their earlobe beforehand, it numbs it up, and they don’t feel pain. It allows them to get their ears pierced without pain, but it’s short-acting. 

What we have now are handheld devices with tips about as long as a pen, 3.5 inches, that allow you to go down precisely to these intercostal nerves that innervate the ribs and give a cold lesion that freezes these nerves. 

The benefit of it is it’s not permanent like cryoablation, like we’ve seen for tumor necrosis, which destroys outside tissues. It’s really a small lesion, about 16 mm x 8 mm, which is enough to engulf the nerve and pretty much stun it. 

It causes axonotmesis, but the epineurium, the endoneurium, and the perineurium — the inner workings of the nerve — stay intact, so it regrows. It just destroys the myelin sheath and the axon.

Glatter: You’re creating a scarring effect; is that what you’re saying? In other words, you’re doing a cold-temperature freeze and stunning the nerve. My question is, does it regrow? Is this a permanent type of injury? 

Schwartz: With Wallerian degeneration, nerves do regrow after injuries.

Unfortunately, as you two probably see in the ER for big traumas, where the nerve is transected, those unfortunately do not grow back. This is considered a grade 2 lesion, so the Wallerian degeneration recurs. The nerves grow, depending on the literature you look at, about 0.5-2 mm per day.

This intervention gives us at least 3 months of relief for the patient, which is in the time frame where the rib fracture will heal, hopefully with no damage to the nerve from the fracture, and they go on living their life without having to take opiates or having to stop their anticoagulation. 

Because prior to this, when I was a pain fellow, we used to put epidurals in many of these patients. The problem with that is patients can’t go home, and if they’re anticoagulated, you can’t place it because of the risk of a spinal hematoma. 

 

Potential Use in Ventilation Weaning

Glatter: This is something we encounter daily, and certainly for those patients who have more numerous rib fractures or flail chest, this could be even more devastating, as well as for those who get intubated.

Do you see any role, in terms of ventilator weaning, in using this technique specifically in the ICU setting? 

Schwartz: That’s an interesting concept. I’m not so sure about ventilator weaning, but we’ve used this in the hospital for rib fractures from traumas where patients had such severe fractures and had to go to the operating room for rib plating, and did necessitate an epidural. We’ve used this to discontinue their epidural and transition them to get the patient home. 

I think that is part of the care, not only in the ER but in the hospital as well. We need to treat the patients, but we also have to have a transition plan to get them out of the hospital. Not that we don’t want to treat our patients, but we have to have a plan to get them home. I’m guessing that might be an interesting stage of research in the future if it does help with weaning from a ventilator. 

Glatter: There are some studies out there suggesting that there can be some utility in terms of ventilator weaning using this technique. The ability of this to change how we manage pain is just incredible.

Sergey, do you feel that this is something that you could implement in your ED with your patients in the near future? 

Motov: Definitely. I have personally been a very big proponent of it. I’m the theoreticist because I’ve covered a great deal of literature, and now having Gary and his team doing this in our institution, it’s a shame not to capitalize on it. I’m slowly moving toward figuring out the way of collaborative effort to have Gary and his team help my team and our colleagues, bring him on board, and maybe broaden the integration for pain management.

I believe, as Gary emphasized, that geriatric traumatic pain injuries are critically important due to the presence of comorbidities, potential drug interactions, and the challenges of managing these factors effectively.

There is one thing I want to bring up, and Gary, please support me on it. The procedure itself is fascinating because it provides long-term pain relief and reduces morbidity. I wouldn’t say mortality, just reduced morbidity. However, we need to be very conscious of the fact that this blockade, this ice-ball freezing of the nerve, can be detrimental to motor nerves. If your whole goal or idea of faster recovery after postoperative knee or hip replacements, or any traumatic lower- or upper-extremity surgery, includes blockade of motor nerves, it’s not going to be beneficial.

I believe the primary therapeutic application of this technology lies in targeting sensory nerves. For instance, intercostal nerves could be a focus in cases of rib fractures. Additionally, this approach shows promise for treating burns, particularly in the lower and upper extremities. Specifically, targeting nerves such as the lateral femoral cutaneous nerve or the anterior femoral cutaneous nerve could effectively neutralize pain and provide significant relief for weeks, if not months.

Based on additional predilection to what particular indications would be, maybe occipital headache with cervicalgia, occipital nerve block — it’s a sensory block — can benefit from it. Slowly but surely, there’s a slew of painful syndromes for which cryoneurolysis might have a great deal of use in the emergency department.

 

Cryoneurolysis for Other Pain Syndromes

Glatter: Gary, I’ll let you expand upon additional uses that you see. You did mention one on our chat earlier this week, which was postmastectomy pain syndrome with the intercostal brachial nerve. That’s a very compelling area of interest, certainly for the number of women that go through mastectomies or lumpectomies and that have axillary dissection or nerve injury.

Schwartz: Post-mastectomy is one way you could use this device and technology to attack painful syndromes, such as postmastectomy syndrome. Mastectomies are one of the most common surgeries performed in the United States, but I believe it’s a top three for post-op chronic pain, which we don’t normally think of. 

There was a great study by a team in San Diego where they did intercostal brachial and intercostal nerve blocks on multiple nerves, and they decreased pain up to 3 months after the surgery and decreased opiates. 

As Sergey alluded to, it’s approved for any peripheral nerve in the body. We’ve used it in our pain office for occipital neuralgia, postherpetic neuralgia, chronic rib pain after fractures, and surgery. Some of the most common uses are for superficial, sensory, genicular nerves, the lateral femoral cutaneous nerve, the anterior femoral cutaneous nerve, and the infrapatellar branch of the saphenous.

You could numb the skin preoperatively before a painful surgery, such as a total knee replacement — or as we like to call it, a total knee arthroplasty — to reduce opiates, improve function, and decrease length of stay. You could attack any sensory nerve.

We’ve utilized that already in our private practice. We’re trying to transition into the hospital to have everyone who gets a knee arthroplasty have this technology to decrease opiates, improve function, and recover faster. 

This is quite interesting and motivating for me because when I first started, we had a femoral catheter to block the motor femoral nerve or an epidural. Patients were in the hospital for 3-5 days with the CPM [continuous passive motion] machine, which is like a medieval torture device that you might see in Mad Max — where you’re kind of moving the patient’s knee back and forth after surgery, and they were miserable, taking patient-controlled analgesia and high-dose opiates. Now, we’re freezing these nerves beforehand, doing our nerve blocks in the operating room with long-acting local anesthetic, and patients are going home the same day with minimal or even no opiates sometimes.

 

Implications for Patient Mobility and DVT Risk

Glatter: You’re getting up to 3 months of relief in that setting, doing it as you described?

Schwartz: Yes, up to 3 months of relief, which is huge, because most patients recovering from a knee arthroplasty, at about the 6- to 8-week mark, have improved range of motion, they have their 110° flexion, they have their extension, and they’re getting back to their normal life.

You cover the whole postoperative rehab, where patients don’t have to get recurring refills, they can participate in physical therapy. As you both know, part of the recovery process is to be able to interact with family and friends without being sleepy, angry, and in pain all day, so they can get back to their normal function.

Glatter: In terms of this procedure, would there be any increase in deep vein thrombosis (DVT) in relation to this, by chance? 

Schwartz: Actually, there’s less of a risk of DVT because patients have less pain, so they can get up and move faster. Some of my surgical colleagues who have implemented this in their practice have gotten away from using the stronger anticoagulation like Xarelto (rivaroxaban) or Coumadin (warfarin), and they just give them baby aspirin postoperatively because their patients are going home the same day and walking. It’s probably safer for patients. There’s no research out there yet to show that, but we all know that the more you move and the more you’re not lying around, the lower the risk of having a DVT or a blood clot. 

There are studies showing that there’s no damage to blood vessels, other than if you stick it with the needle, because the nitrogen gas in this that allows the ice ball to form does not get injected into the body. It’s all resorbed in the machine. The only thing the body sees is this ice ball, which would melt if you hit a blood vessel because we should be 98 °F and the ice ball is -88 °F. There’s no gas injected into the body either, so there’s no risk of a gas embolism. 

 

Training and Implementation

Glatter: I was going to ask you about air emboli, and you perfectly led right into that. 

In terms of training requirements, currently, what do you envision as a way we can train residents and fellows to do this? Is this currently something being considered in curriculum? 

Schwartz: We are going to train our residents first. I’m training the attendings. Before you use this technology, you should have a basic understanding of ultrasound, how to use the device, the different settings, and what the risks are for each procedure you’re doing. 

Let’s say, as Sergey alluded to, with an intercostal nerve block, you could have a pneumothorax. You have to be able to identify the rib, where the nerve should lie, the innermost intercostal muscle you could see on the newer ultrasounds, and where the pleura lies. People should start with just basic ultrasound training and then advance to a typical intercostal nerve block.

Once you master that, the procedure with the device is not much different than an intercostal nerve block, except you have a handheld device and the needle is just as long as a pen, 3.5 inches.

If you could do a nerve block with a spinal needle, you could do the procedure. Once people have the technical ultrasound skills, then they can advance to needle-based procedures, and once you have that training, you could use this procedure safely and efficaciously. 

Glatter: Sergey, do you see this as requiring quite a bit of time and training in your program?

Motov: I mentioned earlier, before we started, that with the advent of ultrasound-guided nerve blocks, the vast majority of physicians are becoming very comfortable and fairly effective with maneuvering a needle and the ultrasound probe. The learning curve is essentially the same. The only difference is, as Gary pointed out, some of the nerves could be new to ED folks, but the technique, the understanding, the visualization, and the knowledge of anatomy are essentially the same. 

As he pointed out, if you can use it with a spinal needle and local anesthetic, the procedure becomes exactly the same. It’s a slightly different drug and a different needle, and instead of local anesthetic, you’re using a gas at cold temperatures, and that’s pretty much it. 

Glatter: Are there any other barriers to adoption in terms of cost, the device itself, or the companies that manufacture these handheld devices?

Schwartz: There’s always cost associated with the new device, needles, and the gas. Thankfully, they’re covered by Medicare, Medicaid, and most commercial insurances in the current framework, which I think is important. I think Congress is seeing the benefits of opiate sparing that Sergey helped lead in the ED.

At AABP Integrative Pain Care and Wellness and Maimonides, we’re doing this intraoperatively as well. I think the government is seeing that. There was a NOPAIN Act passed in 2023 that, starting January 1, 2025, will allow certain approved companies, devices, and medications to have to be repaid by CMS, Centers for Medicare & Medicaid Services, in the hospital setting and in the outpatient departments. In the inpatient surgical stays, we could have less opiates. I think that’s important. It is reimbursed now. Obviously, there is a cost associated. 

The other benefit of this procedure and these techniques is, as Sergey alluded to, it’s done under ultrasound. The way we all learn procedures, whether it be central lines or chest tubes, is the blind technique. There is no good way to practice. In my interventional pain practice, many of our original techniques were done under fluoroscopy, and we don’t want to get extra radiation during practice. 

The benefit of ultrasound and the advent of handheld ultrasound devices is that we can practice scanning and techniques on ourselves and on colleagues, without the fear of radiation. Other than the fact that we need to shower after the surgical lube is on from the scanning gel, you could practice your techniques in a safe way without harming a patient or yourself. 

 

Future Directions in Pain Management Techniques

Glatter: Absolutely. Do you see any role for possibly stellate ganglion blocks, which are a bit riskier and have greater depth?

Schwartz: People are looking at different studies because, again, it’s a needle-based technology. We do many stellate ganglion blocks. I have not done it for this procedure yet, but that’s the next step of what I try. Under ultrasound, we could see the longus colli muscle and we could see the carotid artery. Obviously, we don’t see the ganglion per se, but anatomically, we know where it lies. You could drop a couple of lesions on there and give a theoretic prolonged sympathetic block, which might help with symptoms of complex regional pain syndrome

I know there are some studies that have looked at stellate ganglion blocks for long-COVID symptoms. Unfortunately, it looks like we’re back in another wave right now. I think that’s the next step of the technology. 

Glatter: Getting back to the emergency department, burns are something we see commonly — such painful conditions. This is something that could really provide significant relief, especially with burns that involve the chest wall, not just extremity burns.

Motov: I agree with you. Burns would be a very good indication to utilize this technique. Just listening to you and Gary, another thing that pops into my head, which may have actually some science behind it, would be any traumatic amputations done in a civilian environment or even in the military in a combat situation.

A person who has either an upper or lower extremity that is partially or completely severed or amputated, and the pain — God knows how bad it is — if not properly treated, it is going to be a very long recovery. That’s, I believe, another percutaneous condition where cryoneurolysis will be very beneficial to freeze those nerves, allowing patients to recover through rehab acute care, acute phases, rehabilitation, and move on with their lives. 

Glatter: In the setting of a painful distal radius fracture, a femur fracture, and things of that nature, Gary, do you see this as a modality in conjunction with emergency medicine colleagues as being something that’s going to really become an important part of our armamentarium?

Schwartz: I do think it’s going to become more important in the future, as there are more studies to show what nerves you could block with cryoneurolysis in the longer term. I think you might see people start using these for fractures, especially for fractures that are not operable at the time or if a patient needs to be optimized prior to surgery.

As Sergey alluded to, it’s optimal in burns. People have been looking for relief of stump pain or postamputation pain. There’s a big researcher in Canada who’s been looking at pain with spasticity for people with cerebral palsy and poststroke issues, where they can’t move and they have pain moving an extremity after these conditions. We’re at just the tip of the iceberg as to where people are going to use this hand-held technology in the future. 

Glatter: We use long-acting nerve blocks for hip fractures already in the emergency department. Why not employ this technique, which would have longer effects and limit opiate use?

Schwartz: It might even help a certain subset of the population, at least in Brooklyn, where we have a large elderly population. I believe it’s one of the oldest boroughs in the country, and definitely in New York. 

There are some people that go on to surgery just because they might be bedbound, but it’s the pain that is dictating their surgical procedure, not that they’re ever going to walk again.

It’s maybe the next step to look for. If you could block this nerve for 3 months or longer, they’re still going to be bedbound, but maybe you could avoid a surgical procedure that carries its own morbidity and mortality, which I see a big interest in in the future. 

Glatter: Absolutely. The idea behind treating spasticity is very important from an occupational therapy standpoint — eating, activities of daily living — just the basics.

Getting someone’s fingers released, being able to move their legs again, and getting them out of contracture states, I think, has a huge role. 

Schwartz: Not only for the patient but also for the caregivers. For many of these patients, if they’re contracted fully and the pain from the spasticity is preventing their caregivers from moving them, it’s difficult to put on a shirt, pants, and so on.

One other point I’d like to make is that it’s reproducible. It’s not one-and-done. If the pain comes back from any of these conditions, you could treat again with another cryoneurolysis treatment. The current literature to date shows that it’s just as effective time and time again. I’ve seen clinically that you can repeat this procedure, whereas some of our other procedures that we do in medicine are not as reproducible, which is important for some of these chronic conditions.

Glatter: You had mentioned reimbursement earlier. Currently, this procedure is reimbursed under Medicare, Medicaid, and third-party payers, I assume? 

Schwartz: Not all, but many commercial insurers. Yes for Medicare. 

 

Final Takeaways

Glatter: Reimbursement has to be really universal because if this is shown to be more effective and limits opiate use, then there’s no question in my mind that this is such a groundbreaking procedure.

I’ll let you both give a few pearls for our audience to summarize our discussion.

Motov: I’d say it’s somewhat long overdue that this technique and pain-relieving modality should enter the emergency department, with the auspices and the beautiful collaborative effort between emergency department folks and interventional anesthesiologists, pain management specialists, collaborative training, and a collaborative goal of improving patients’ pain throughout the entire journey during the healthcare system.

That would be my only pearl. Just reach out to your colleagues within your respective institutions who you believe have aptitude, knowledge, and expertise. Reach out, get trained, and start passing down the knowledge to your faculty, and by virtue of extension, to your fellow residents and colleagues.

Schwartz: He took the words right out of my mouth. Communication and collaboration are the two most important things. There’s a shortage of physicians in this country. We can only each do so much, so we should each utilize and implement this technology to affect and help as many patients as possible.

We can decrease the amount of opiates, help our patients, help our family members in our community live with decreased pain, improve their function, and just get back to their lives and keep pushing the envelope of what’s the next step in treatment.

Again, like we went from giving opiates for this and that’s it — maybe an epidural, maybe a 5- to 6-hour intercostal nerve block — to fascial plane blocks like Sergey said, to more advanced procedures, to now we can give months of relief. 

I think the communication, the collaboration, and the camaraderie among our different specialties are important to push the envelope to help our patients. 

Glatter: That’s so well put. I completely agree. 

I want to thank both of you for a very lively discussion. It was very informative. Your expertise is greatly appreciated and will certainly benefit our audience. Thank you both again.

Dr. Glatter is an assistant professor of emergency medicine at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. Dr. Motov is professor of emergency medicine and director of research in the Department of Emergency Medicine at Maimonides Medical Center in Brooklyn, New York. Dr. Schwartz is co-owner and primary clinic director at AABP Integrative Pain Care in Brooklyn, New York. Schwartz currently serves as the co-director of AABP Integrative Pain Care and Wellness and the vice chair of pain and anesthesiology for Maimonides Medical Center. Dr. Schwartz reported conflicts of interest with Pacira Biosciences and Dorsal Health; neither Dr. Glatter nor Dr. Motov reported relevant conflicts of interest.

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

This transcript has been edited for clarity. 

Robert D. Glatter, MD: Hi. I’m Dr. Robert Glatter, medical advisor for Medscape Emergency Medicine. Joining me today to discuss a novel way to treat pain related to conditions such as rib fractures and burns is Dr. Sergey Motov, an emergency physician with expertise in pain management and research director in the Department of Emergency Medicine at Maimonides Medical Center in Brooklyn, New York.

Also joining me is Dr. Gary Schwartz, vice chair of pain and anesthesiology at Maimonides Medical Center. Dr. Schwartz is board certified in anesthesiology and interventional pain management. 

Welcome, Sergey and Gary. 

Sergey M. Motov, MD: Thank you, Robert. 

Gary S. Schwartz, MD: Thank you, Robert. 

 

Traditional Approaches to Pain Relief

Glatter: It’s a pleasure to have you both. Sergey, we were chatting earlier this week and you had mentioned a novel approach to treating a common condition we encounter in the emergency department — rib fractures.

As we all know, they’re very painful and can lead to pulmonary complications, including atelectasis, pneumonia due to splinting and lack of proper pain management, along with the use of incentive spirometry.

Sergey and Gary, can you describe traditional approaches to alleviating the pain associated with rib fractures? What do we typically use? Then we’ll get to some novel treatments that we’re here to discuss.

Motov: I’m going to use the emergency medicine approach to rib fractures. As you pointed out, pain relief is of utmost importance.

With the advent and acquiring of the amazing technique of interventional pain management, physicians, for the most part, are very astute about providing nerve blocks to alleviate pain, at least in immediate need. I’m talking about the relatively short term, 1-5 hours, in the emergency department.

Primarily, we focus on fascial plane blocks such as serratus anterior plane block. Traditionally, ED physicians don’t use much of the intercostal blocks. At times, we can direct the spinal block to cover the lateral aspect of the chest wall. 

As part of the multimodal approach, we can use NSAIDs. If there’s a contraindication, we can use opioids. There are some data to support consideration of using topical formularies such as a lidocaine patch, but they are somewhat conflicting. 

The question becomes what you’re going to send a patient home with. Again, traditional teaching is either opioids, immediate release with a short course, plus or minus NSAIDs, plus or minus acetaminophen.

The issue with rib fractures is that, while we can manage immediate and super-acute pain presentation in the ED and then discharge up to 24-72 hours, what happens afterwards is very challenging. Acute intercostal neuralgia related to traumatic rib fractures is semi-manageable, but if it’s inappropriately treated, it has a great tendency to transform into chronic intercostal neuralgia. It contributes a great deal of disability and morbidity. 

Several years ago, I came across an entity called cryoneurolysis (cryo ─ cold temperature; neurolysis ─ freezing the nerve). I’m excited to be here today because Gary is the one who’s pioneering and championing this technique in our institution. 

 

Cryoneurolysis: Mechanisms of Action and Benefits

Glatter: Gary, what do you see as the main role for this procedure at this time? 

Schwartz: As Sergey alluded to, the traditional approach of opiates has side effects (ie, constipation, addiction, and tolerance). Unfortunately, many of these rib fractures occur in older patients. They come in anticoagulated, so they can’t have NSAIDs. 

Sergey and his team in the ER have been pioneers in giving short-acting local anesthetic blocks that could last anywhere from 12 to 24 hours. There are long-acting local anesthetics that we can get out to 72 hours.

Unfortunately, these rib fractures and the pain associated with them, in addition to the intercostal neuralgia, could take weeks to heal. That’s where cryoneurolysis comes in. We’re all used to ice or cold temperature. For example, if your child gets an ear piercing, they put some ice on their earlobe beforehand, it numbs it up, and they don’t feel pain. It allows them to get their ears pierced without pain, but it’s short-acting. 

What we have now are handheld devices with tips about as long as a pen, 3.5 inches, that allow you to go down precisely to these intercostal nerves that innervate the ribs and give a cold lesion that freezes these nerves. 

The benefit of it is it’s not permanent like cryoablation, like we’ve seen for tumor necrosis, which destroys outside tissues. It’s really a small lesion, about 16 mm x 8 mm, which is enough to engulf the nerve and pretty much stun it. 

It causes axonotmesis, but the epineurium, the endoneurium, and the perineurium — the inner workings of the nerve — stay intact, so it regrows. It just destroys the myelin sheath and the axon.

Glatter: You’re creating a scarring effect; is that what you’re saying? In other words, you’re doing a cold-temperature freeze and stunning the nerve. My question is, does it regrow? Is this a permanent type of injury? 

Schwartz: With Wallerian degeneration, nerves do regrow after injuries.

Unfortunately, as you two probably see in the ER for big traumas, where the nerve is transected, those unfortunately do not grow back. This is considered a grade 2 lesion, so the Wallerian degeneration recurs. The nerves grow, depending on the literature you look at, about 0.5-2 mm per day.

This intervention gives us at least 3 months of relief for the patient, which is in the time frame where the rib fracture will heal, hopefully with no damage to the nerve from the fracture, and they go on living their life without having to take opiates or having to stop their anticoagulation. 

Because prior to this, when I was a pain fellow, we used to put epidurals in many of these patients. The problem with that is patients can’t go home, and if they’re anticoagulated, you can’t place it because of the risk of a spinal hematoma. 

 

Potential Use in Ventilation Weaning

Glatter: This is something we encounter daily, and certainly for those patients who have more numerous rib fractures or flail chest, this could be even more devastating, as well as for those who get intubated.

Do you see any role, in terms of ventilator weaning, in using this technique specifically in the ICU setting? 

Schwartz: That’s an interesting concept. I’m not so sure about ventilator weaning, but we’ve used this in the hospital for rib fractures from traumas where patients had such severe fractures and had to go to the operating room for rib plating, and did necessitate an epidural. We’ve used this to discontinue their epidural and transition them to get the patient home. 

I think that is part of the care, not only in the ER but in the hospital as well. We need to treat the patients, but we also have to have a transition plan to get them out of the hospital. Not that we don’t want to treat our patients, but we have to have a plan to get them home. I’m guessing that might be an interesting stage of research in the future if it does help with weaning from a ventilator. 

Glatter: There are some studies out there suggesting that there can be some utility in terms of ventilator weaning using this technique. The ability of this to change how we manage pain is just incredible.

Sergey, do you feel that this is something that you could implement in your ED with your patients in the near future? 

Motov: Definitely. I have personally been a very big proponent of it. I’m the theoreticist because I’ve covered a great deal of literature, and now having Gary and his team doing this in our institution, it’s a shame not to capitalize on it. I’m slowly moving toward figuring out the way of collaborative effort to have Gary and his team help my team and our colleagues, bring him on board, and maybe broaden the integration for pain management.

I believe, as Gary emphasized, that geriatric traumatic pain injuries are critically important due to the presence of comorbidities, potential drug interactions, and the challenges of managing these factors effectively.

There is one thing I want to bring up, and Gary, please support me on it. The procedure itself is fascinating because it provides long-term pain relief and reduces morbidity. I wouldn’t say mortality, just reduced morbidity. However, we need to be very conscious of the fact that this blockade, this ice-ball freezing of the nerve, can be detrimental to motor nerves. If your whole goal or idea of faster recovery after postoperative knee or hip replacements, or any traumatic lower- or upper-extremity surgery, includes blockade of motor nerves, it’s not going to be beneficial.

I believe the primary therapeutic application of this technology lies in targeting sensory nerves. For instance, intercostal nerves could be a focus in cases of rib fractures. Additionally, this approach shows promise for treating burns, particularly in the lower and upper extremities. Specifically, targeting nerves such as the lateral femoral cutaneous nerve or the anterior femoral cutaneous nerve could effectively neutralize pain and provide significant relief for weeks, if not months.

Based on additional predilection to what particular indications would be, maybe occipital headache with cervicalgia, occipital nerve block — it’s a sensory block — can benefit from it. Slowly but surely, there’s a slew of painful syndromes for which cryoneurolysis might have a great deal of use in the emergency department.

 

Cryoneurolysis for Other Pain Syndromes

Glatter: Gary, I’ll let you expand upon additional uses that you see. You did mention one on our chat earlier this week, which was postmastectomy pain syndrome with the intercostal brachial nerve. That’s a very compelling area of interest, certainly for the number of women that go through mastectomies or lumpectomies and that have axillary dissection or nerve injury.

Schwartz: Post-mastectomy is one way you could use this device and technology to attack painful syndromes, such as postmastectomy syndrome. Mastectomies are one of the most common surgeries performed in the United States, but I believe it’s a top three for post-op chronic pain, which we don’t normally think of. 

There was a great study by a team in San Diego where they did intercostal brachial and intercostal nerve blocks on multiple nerves, and they decreased pain up to 3 months after the surgery and decreased opiates. 

As Sergey alluded to, it’s approved for any peripheral nerve in the body. We’ve used it in our pain office for occipital neuralgia, postherpetic neuralgia, chronic rib pain after fractures, and surgery. Some of the most common uses are for superficial, sensory, genicular nerves, the lateral femoral cutaneous nerve, the anterior femoral cutaneous nerve, and the infrapatellar branch of the saphenous.

You could numb the skin preoperatively before a painful surgery, such as a total knee replacement — or as we like to call it, a total knee arthroplasty — to reduce opiates, improve function, and decrease length of stay. You could attack any sensory nerve.

We’ve utilized that already in our private practice. We’re trying to transition into the hospital to have everyone who gets a knee arthroplasty have this technology to decrease opiates, improve function, and recover faster. 

This is quite interesting and motivating for me because when I first started, we had a femoral catheter to block the motor femoral nerve or an epidural. Patients were in the hospital for 3-5 days with the CPM [continuous passive motion] machine, which is like a medieval torture device that you might see in Mad Max — where you’re kind of moving the patient’s knee back and forth after surgery, and they were miserable, taking patient-controlled analgesia and high-dose opiates. Now, we’re freezing these nerves beforehand, doing our nerve blocks in the operating room with long-acting local anesthetic, and patients are going home the same day with minimal or even no opiates sometimes.

 

Implications for Patient Mobility and DVT Risk

Glatter: You’re getting up to 3 months of relief in that setting, doing it as you described?

Schwartz: Yes, up to 3 months of relief, which is huge, because most patients recovering from a knee arthroplasty, at about the 6- to 8-week mark, have improved range of motion, they have their 110° flexion, they have their extension, and they’re getting back to their normal life.

You cover the whole postoperative rehab, where patients don’t have to get recurring refills, they can participate in physical therapy. As you both know, part of the recovery process is to be able to interact with family and friends without being sleepy, angry, and in pain all day, so they can get back to their normal function.

Glatter: In terms of this procedure, would there be any increase in deep vein thrombosis (DVT) in relation to this, by chance? 

Schwartz: Actually, there’s less of a risk of DVT because patients have less pain, so they can get up and move faster. Some of my surgical colleagues who have implemented this in their practice have gotten away from using the stronger anticoagulation like Xarelto (rivaroxaban) or Coumadin (warfarin), and they just give them baby aspirin postoperatively because their patients are going home the same day and walking. It’s probably safer for patients. There’s no research out there yet to show that, but we all know that the more you move and the more you’re not lying around, the lower the risk of having a DVT or a blood clot. 

There are studies showing that there’s no damage to blood vessels, other than if you stick it with the needle, because the nitrogen gas in this that allows the ice ball to form does not get injected into the body. It’s all resorbed in the machine. The only thing the body sees is this ice ball, which would melt if you hit a blood vessel because we should be 98 °F and the ice ball is -88 °F. There’s no gas injected into the body either, so there’s no risk of a gas embolism. 

 

Training and Implementation

Glatter: I was going to ask you about air emboli, and you perfectly led right into that. 

In terms of training requirements, currently, what do you envision as a way we can train residents and fellows to do this? Is this currently something being considered in curriculum? 

Schwartz: We are going to train our residents first. I’m training the attendings. Before you use this technology, you should have a basic understanding of ultrasound, how to use the device, the different settings, and what the risks are for each procedure you’re doing. 

Let’s say, as Sergey alluded to, with an intercostal nerve block, you could have a pneumothorax. You have to be able to identify the rib, where the nerve should lie, the innermost intercostal muscle you could see on the newer ultrasounds, and where the pleura lies. People should start with just basic ultrasound training and then advance to a typical intercostal nerve block.

Once you master that, the procedure with the device is not much different than an intercostal nerve block, except you have a handheld device and the needle is just as long as a pen, 3.5 inches.

If you could do a nerve block with a spinal needle, you could do the procedure. Once people have the technical ultrasound skills, then they can advance to needle-based procedures, and once you have that training, you could use this procedure safely and efficaciously. 

Glatter: Sergey, do you see this as requiring quite a bit of time and training in your program?

Motov: I mentioned earlier, before we started, that with the advent of ultrasound-guided nerve blocks, the vast majority of physicians are becoming very comfortable and fairly effective with maneuvering a needle and the ultrasound probe. The learning curve is essentially the same. The only difference is, as Gary pointed out, some of the nerves could be new to ED folks, but the technique, the understanding, the visualization, and the knowledge of anatomy are essentially the same. 

As he pointed out, if you can use it with a spinal needle and local anesthetic, the procedure becomes exactly the same. It’s a slightly different drug and a different needle, and instead of local anesthetic, you’re using a gas at cold temperatures, and that’s pretty much it. 

Glatter: Are there any other barriers to adoption in terms of cost, the device itself, or the companies that manufacture these handheld devices?

Schwartz: There’s always cost associated with the new device, needles, and the gas. Thankfully, they’re covered by Medicare, Medicaid, and most commercial insurances in the current framework, which I think is important. I think Congress is seeing the benefits of opiate sparing that Sergey helped lead in the ED.

At AABP Integrative Pain Care and Wellness and Maimonides, we’re doing this intraoperatively as well. I think the government is seeing that. There was a NOPAIN Act passed in 2023 that, starting January 1, 2025, will allow certain approved companies, devices, and medications to have to be repaid by CMS, Centers for Medicare & Medicaid Services, in the hospital setting and in the outpatient departments. In the inpatient surgical stays, we could have less opiates. I think that’s important. It is reimbursed now. Obviously, there is a cost associated. 

The other benefit of this procedure and these techniques is, as Sergey alluded to, it’s done under ultrasound. The way we all learn procedures, whether it be central lines or chest tubes, is the blind technique. There is no good way to practice. In my interventional pain practice, many of our original techniques were done under fluoroscopy, and we don’t want to get extra radiation during practice. 

The benefit of ultrasound and the advent of handheld ultrasound devices is that we can practice scanning and techniques on ourselves and on colleagues, without the fear of radiation. Other than the fact that we need to shower after the surgical lube is on from the scanning gel, you could practice your techniques in a safe way without harming a patient or yourself. 

 

Future Directions in Pain Management Techniques

Glatter: Absolutely. Do you see any role for possibly stellate ganglion blocks, which are a bit riskier and have greater depth?

Schwartz: People are looking at different studies because, again, it’s a needle-based technology. We do many stellate ganglion blocks. I have not done it for this procedure yet, but that’s the next step of what I try. Under ultrasound, we could see the longus colli muscle and we could see the carotid artery. Obviously, we don’t see the ganglion per se, but anatomically, we know where it lies. You could drop a couple of lesions on there and give a theoretic prolonged sympathetic block, which might help with symptoms of complex regional pain syndrome

I know there are some studies that have looked at stellate ganglion blocks for long-COVID symptoms. Unfortunately, it looks like we’re back in another wave right now. I think that’s the next step of the technology. 

Glatter: Getting back to the emergency department, burns are something we see commonly — such painful conditions. This is something that could really provide significant relief, especially with burns that involve the chest wall, not just extremity burns.

Motov: I agree with you. Burns would be a very good indication to utilize this technique. Just listening to you and Gary, another thing that pops into my head, which may have actually some science behind it, would be any traumatic amputations done in a civilian environment or even in the military in a combat situation.

A person who has either an upper or lower extremity that is partially or completely severed or amputated, and the pain — God knows how bad it is — if not properly treated, it is going to be a very long recovery. That’s, I believe, another percutaneous condition where cryoneurolysis will be very beneficial to freeze those nerves, allowing patients to recover through rehab acute care, acute phases, rehabilitation, and move on with their lives. 

Glatter: In the setting of a painful distal radius fracture, a femur fracture, and things of that nature, Gary, do you see this as a modality in conjunction with emergency medicine colleagues as being something that’s going to really become an important part of our armamentarium?

Schwartz: I do think it’s going to become more important in the future, as there are more studies to show what nerves you could block with cryoneurolysis in the longer term. I think you might see people start using these for fractures, especially for fractures that are not operable at the time or if a patient needs to be optimized prior to surgery.

As Sergey alluded to, it’s optimal in burns. People have been looking for relief of stump pain or postamputation pain. There’s a big researcher in Canada who’s been looking at pain with spasticity for people with cerebral palsy and poststroke issues, where they can’t move and they have pain moving an extremity after these conditions. We’re at just the tip of the iceberg as to where people are going to use this hand-held technology in the future. 

Glatter: We use long-acting nerve blocks for hip fractures already in the emergency department. Why not employ this technique, which would have longer effects and limit opiate use?

Schwartz: It might even help a certain subset of the population, at least in Brooklyn, where we have a large elderly population. I believe it’s one of the oldest boroughs in the country, and definitely in New York. 

There are some people that go on to surgery just because they might be bedbound, but it’s the pain that is dictating their surgical procedure, not that they’re ever going to walk again.

It’s maybe the next step to look for. If you could block this nerve for 3 months or longer, they’re still going to be bedbound, but maybe you could avoid a surgical procedure that carries its own morbidity and mortality, which I see a big interest in in the future. 

Glatter: Absolutely. The idea behind treating spasticity is very important from an occupational therapy standpoint — eating, activities of daily living — just the basics.

Getting someone’s fingers released, being able to move their legs again, and getting them out of contracture states, I think, has a huge role. 

Schwartz: Not only for the patient but also for the caregivers. For many of these patients, if they’re contracted fully and the pain from the spasticity is preventing their caregivers from moving them, it’s difficult to put on a shirt, pants, and so on.

One other point I’d like to make is that it’s reproducible. It’s not one-and-done. If the pain comes back from any of these conditions, you could treat again with another cryoneurolysis treatment. The current literature to date shows that it’s just as effective time and time again. I’ve seen clinically that you can repeat this procedure, whereas some of our other procedures that we do in medicine are not as reproducible, which is important for some of these chronic conditions.

Glatter: You had mentioned reimbursement earlier. Currently, this procedure is reimbursed under Medicare, Medicaid, and third-party payers, I assume? 

Schwartz: Not all, but many commercial insurers. Yes for Medicare. 

 

Final Takeaways

Glatter: Reimbursement has to be really universal because if this is shown to be more effective and limits opiate use, then there’s no question in my mind that this is such a groundbreaking procedure.

I’ll let you both give a few pearls for our audience to summarize our discussion.

Motov: I’d say it’s somewhat long overdue that this technique and pain-relieving modality should enter the emergency department, with the auspices and the beautiful collaborative effort between emergency department folks and interventional anesthesiologists, pain management specialists, collaborative training, and a collaborative goal of improving patients’ pain throughout the entire journey during the healthcare system.

That would be my only pearl. Just reach out to your colleagues within your respective institutions who you believe have aptitude, knowledge, and expertise. Reach out, get trained, and start passing down the knowledge to your faculty, and by virtue of extension, to your fellow residents and colleagues.

Schwartz: He took the words right out of my mouth. Communication and collaboration are the two most important things. There’s a shortage of physicians in this country. We can only each do so much, so we should each utilize and implement this technology to affect and help as many patients as possible.

We can decrease the amount of opiates, help our patients, help our family members in our community live with decreased pain, improve their function, and just get back to their lives and keep pushing the envelope of what’s the next step in treatment.

Again, like we went from giving opiates for this and that’s it — maybe an epidural, maybe a 5- to 6-hour intercostal nerve block — to fascial plane blocks like Sergey said, to more advanced procedures, to now we can give months of relief. 

I think the communication, the collaboration, and the camaraderie among our different specialties are important to push the envelope to help our patients. 

Glatter: That’s so well put. I completely agree. 

I want to thank both of you for a very lively discussion. It was very informative. Your expertise is greatly appreciated and will certainly benefit our audience. Thank you both again.

Dr. Glatter is an assistant professor of emergency medicine at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. Dr. Motov is professor of emergency medicine and director of research in the Department of Emergency Medicine at Maimonides Medical Center in Brooklyn, New York. Dr. Schwartz is co-owner and primary clinic director at AABP Integrative Pain Care in Brooklyn, New York. Schwartz currently serves as the co-director of AABP Integrative Pain Care and Wellness and the vice chair of pain and anesthesiology for Maimonides Medical Center. Dr. Schwartz reported conflicts of interest with Pacira Biosciences and Dorsal Health; neither Dr. Glatter nor Dr. Motov reported relevant conflicts of interest.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Un-Gate On Date
Use ProPublica
CFC Schedule Remove Status
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date