MDedge Emergency Medicine

A new federal rule could force hospitals and doctors’ groups to boost health cybersecurity measures to better protect patients’ health information and prevent ransomware attacks. Some of the proposed requirements could be expensive for healthcare providers.

The proposed rule, issued by the US Department of Health & Human Services (HHS) and published on January 6 in the Federal Register, marks the first time in a decade that the federal government has updated regulations governing the security of private health information (PHI) that’s kept or shared online. Comments on the rule are due on March 6.

Because the risks for cyberattacks have increased exponentially, “there is a greater need to invest than ever before in both people and technologies to secure patient information,” Adam Greene, an attorney at Davis Wright Tremaine in Washington, DC, who advises healthcare clients on cybersecurity, said in an interview.

Bad actors continue to evolve and are often far ahead of their targets, added Mark Fox, privacy and research compliance officer for the American College of Cardiology.

In the proposed rule, HHS noted that breaches have risen by more than 50% since 2020. Damages from health data breaches are more expensive than in any other sector, averaging $10 million per incident, said HHS.

The damage can continue for years, as much of the data — such as date of birth — in PHI are “immutable,” unlike a credit card number, the agency said. A review of breach reports made to HHS’ Office for Civil Rights shows near-daily data breaches affecting hundreds to tens of thousands of patients. Since December 1 alone, healthcare providers reported breaches affecting nearly 3 million US patients, according to federal data.

Debi Carr, a Florida-based cybersecurity consultant for small physician and dental practices, welcomed the new proposal. “Many practices are clinging to doing things the way they have always done it, and hackers are taking full advantage of that mindset,” she said in an interview. “We have to change our mindset.”

Among the proposal’s recommendations:

• A shift away from making security specifications “addressable” to required. Fox said that many interpreted addressable to mean optional. The clarification is important. The government will require greater accountability, including a requirement to annually revise the risk analysis, to review policies and procedures and implementation, and to perform penetration testing, said Greene.
• Requiring multifactor authentication (MFA) and encryption of PHI at rest and in transit. “A reasonable person who does security will tell you that should be a requirement,” said Fox. Carr added that the February 2024 Change Healthcare ransomware attack happened because workers at the payment processing company were not using MFA.
• Requiring all entities to verify at least once a year that “business associates” have put into place the required safeguards; the associates would need to provide a written analysis of relevant electronic information systems by a subject matter expert and a written certification that the analysis has been performed and is accurate. In the past, the rule “only required that you sign a business associate agreement” with the associate, which could be a payer, a pharmacy, or another physician practice, said Fox. The rule would require all entities to get certification that the controls are in place.
• Requiring a detailed map of an electronic network. For a physician practice, that means creating an inventory of all the technology assets, including devices, applications, and anything that would touch electronic PHI, and then creating a map of how it comes into the office, flows through it, and departs, said Greene.
• Having a plan of action in the case of a breach. The rule will require written procedures to restore certain relevant systems and data within 72 hours and written incident response plans.

Some physician practices — especially those still relying on passwords instead of more sophisticated MFA or encryption — may have to invest significantly to strengthen their information security, said Greene. Smaller organizations, for example, may need to upgrade systems to ensure that user access is terminated within an hour after someone’s employment ends.

Carr said practices should not view the investments as a burden. The regulation “will force practices to implement best cybersecurity practices,” she said.

Implementing those best practices serves as insurance, said Fox. He suggests that anyone in doubt “talk to someone who’s actually lived through a breach and had to recover.”

Tampa General Hospital in Florida, for instance, recently settled a class action suit, agreeing to pay $6.8 million to patients whose PHI was compromised.

It is not certain whether or when the health cybersecurity rule will be made final.

The incoming Trump administration could cancel or delay the rulemaking process.

Even if it continues, “I would not expect a final rule in 2025,” said Greene. He estimates that the rule would not take effect until at least 2026; healthcare entities would have 180 days to comply. Still, those 180 days can go by fast.

“I would say don’t panic, but don’t ignore it either,” he said.

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

A new federal rule could force hospitals and doctors’ groups to boost health cybersecurity measures to better protect patients’ health information and prevent ransomware attacks. Some of the proposed requirements could be expensive for healthcare providers.

The proposed rule, issued by the US Department of Health & Human Services (HHS) and published on January 6 in the Federal Register, marks the first time in a decade that the federal government has updated regulations governing the security of private health information (PHI) that’s kept or shared online. Comments on the rule are due on March 6.

Because the risks for cyberattacks have increased exponentially, “there is a greater need to invest than ever before in both people and technologies to secure patient information,” Adam Greene, an attorney at Davis Wright Tremaine in Washington, DC, who advises healthcare clients on cybersecurity, said in an interview.

Bad actors continue to evolve and are often far ahead of their targets, added Mark Fox, privacy and research compliance officer for the American College of Cardiology.

In the proposed rule, HHS noted that breaches have risen by more than 50% since 2020. Damages from health data breaches are more expensive than in any other sector, averaging $10 million per incident, said HHS.

The damage can continue for years, as much of the data — such as date of birth — in PHI are “immutable,” unlike a credit card number, the agency said. A review of breach reports made to HHS’ Office for Civil Rights shows near-daily data breaches affecting hundreds to tens of thousands of patients. Since December 1 alone, healthcare providers reported breaches affecting nearly 3 million US patients, according to federal data.

Debi Carr, a Florida-based cybersecurity consultant for small physician and dental practices, welcomed the new proposal. “Many practices are clinging to doing things the way they have always done it, and hackers are taking full advantage of that mindset,” she said in an interview. “We have to change our mindset.”

Among the proposal’s recommendations:

• A shift away from making security specifications “addressable” to required. Fox said that many interpreted addressable to mean optional. The clarification is important. The government will require greater accountability, including a requirement to annually revise the risk analysis, to review policies and procedures and implementation, and to perform penetration testing, said Greene.
• Requiring multifactor authentication (MFA) and encryption of PHI at rest and in transit. “A reasonable person who does security will tell you that should be a requirement,” said Fox. Carr added that the February 2024 Change Healthcare ransomware attack happened because workers at the payment processing company were not using MFA.
• Requiring all entities to verify at least once a year that “business associates” have put into place the required safeguards; the associates would need to provide a written analysis of relevant electronic information systems by a subject matter expert and a written certification that the analysis has been performed and is accurate. In the past, the rule “only required that you sign a business associate agreement” with the associate, which could be a payer, a pharmacy, or another physician practice, said Fox. The rule would require all entities to get certification that the controls are in place.
• Requiring a detailed map of an electronic network. For a physician practice, that means creating an inventory of all the technology assets, including devices, applications, and anything that would touch electronic PHI, and then creating a map of how it comes into the office, flows through it, and departs, said Greene.
• Having a plan of action in the case of a breach. The rule will require written procedures to restore certain relevant systems and data within 72 hours and written incident response plans.

Some physician practices — especially those still relying on passwords instead of more sophisticated MFA or encryption — may have to invest significantly to strengthen their information security, said Greene. Smaller organizations, for example, may need to upgrade systems to ensure that user access is terminated within an hour after someone’s employment ends.

Carr said practices should not view the investments as a burden. The regulation “will force practices to implement best cybersecurity practices,” she said.

Implementing those best practices serves as insurance, said Fox. He suggests that anyone in doubt “talk to someone who’s actually lived through a breach and had to recover.”

Tampa General Hospital in Florida, for instance, recently settled a class action suit, agreeing to pay $6.8 million to patients whose PHI was compromised.

It is not certain whether or when the health cybersecurity rule will be made final.

The incoming Trump administration could cancel or delay the rulemaking process.

Even if it continues, “I would not expect a final rule in 2025,” said Greene. He estimates that the rule would not take effect until at least 2026; healthcare entities would have 180 days to comply. Still, those 180 days can go by fast.

“I would say don’t panic, but don’t ignore it either,” he said.

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

A new federal rule could force hospitals and doctors’ groups to boost health cybersecurity measures to better protect patients’ health information and prevent ransomware attacks. Some of the proposed requirements could be expensive for healthcare providers.

The proposed rule, issued by the US Department of Health & Human Services (HHS) and published on January 6 in the Federal Register, marks the first time in a decade that the federal government has updated regulations governing the security of private health information (PHI) that’s kept or shared online. Comments on the rule are due on March 6.

Because the risks for cyberattacks have increased exponentially, “there is a greater need to invest than ever before in both people and technologies to secure patient information,” Adam Greene, an attorney at Davis Wright Tremaine in Washington, DC, who advises healthcare clients on cybersecurity, said in an interview.

Bad actors continue to evolve and are often far ahead of their targets, added Mark Fox, privacy and research compliance officer for the American College of Cardiology.

In the proposed rule, HHS noted that breaches have risen by more than 50% since 2020. Damages from health data breaches are more expensive than in any other sector, averaging $10 million per incident, said HHS.

The damage can continue for years, as much of the data — such as date of birth — in PHI are “immutable,” unlike a credit card number, the agency said. A review of breach reports made to HHS’ Office for Civil Rights shows near-daily data breaches affecting hundreds to tens of thousands of patients. Since December 1 alone, healthcare providers reported breaches affecting nearly 3 million US patients, according to federal data.

Debi Carr, a Florida-based cybersecurity consultant for small physician and dental practices, welcomed the new proposal. “Many practices are clinging to doing things the way they have always done it, and hackers are taking full advantage of that mindset,” she said in an interview. “We have to change our mindset.”

Among the proposal’s recommendations:

• A shift away from making security specifications “addressable” to required. Fox said that many interpreted addressable to mean optional. The clarification is important. The government will require greater accountability, including a requirement to annually revise the risk analysis, to review policies and procedures and implementation, and to perform penetration testing, said Greene.
• Requiring multifactor authentication (MFA) and encryption of PHI at rest and in transit. “A reasonable person who does security will tell you that should be a requirement,” said Fox. Carr added that the February 2024 Change Healthcare ransomware attack happened because workers at the payment processing company were not using MFA.
• Requiring all entities to verify at least once a year that “business associates” have put into place the required safeguards; the associates would need to provide a written analysis of relevant electronic information systems by a subject matter expert and a written certification that the analysis has been performed and is accurate. In the past, the rule “only required that you sign a business associate agreement” with the associate, which could be a payer, a pharmacy, or another physician practice, said Fox. The rule would require all entities to get certification that the controls are in place.
• Requiring a detailed map of an electronic network. For a physician practice, that means creating an inventory of all the technology assets, including devices, applications, and anything that would touch electronic PHI, and then creating a map of how it comes into the office, flows through it, and departs, said Greene.
• Having a plan of action in the case of a breach. The rule will require written procedures to restore certain relevant systems and data within 72 hours and written incident response plans.

Some physician practices — especially those still relying on passwords instead of more sophisticated MFA or encryption — may have to invest significantly to strengthen their information security, said Greene. Smaller organizations, for example, may need to upgrade systems to ensure that user access is terminated within an hour after someone’s employment ends.

Carr said practices should not view the investments as a burden. The regulation “will force practices to implement best cybersecurity practices,” she said.

Implementing those best practices serves as insurance, said Fox. He suggests that anyone in doubt “talk to someone who’s actually lived through a breach and had to recover.”

Tampa General Hospital in Florida, for instance, recently settled a class action suit, agreeing to pay $6.8 million to patients whose PHI was compromised.

It is not certain whether or when the health cybersecurity rule will be made final.

The incoming Trump administration could cancel or delay the rulemaking process.

Even if it continues, “I would not expect a final rule in 2025,” said Greene. He estimates that the rule would not take effect until at least 2026; healthcare entities would have 180 days to comply. Still, those 180 days can go by fast.

“I would say don’t panic, but don’t ignore it either,” he said.

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

Higher rates of leaving the emergency department (ED) without being seen are linked to increased short-term mortality or hospitalization, according to a cohort study in Ontario, Canada.

“We found that after 2020, there was a 14% higher risk for death or hospitalization within 7 days” among patients who left without being seen (LWBS), Candace McNaughton, MD, PhD, associate professor of medicine at the University of Toronto and scientist at Sunnybrook Research Institute, both in Toronto, Ontario, Canada, told this news organization.

“When we looked at death by itself, there was a 46% higher risk after 2020,” she said. “Even 30 days after a LWBS ED visit, there was still a 5% increased risk for death/hospitalization and a 24% increased risk for death.”

The study was published in the Journal of the American College of Emergency Physicians Open.

 

LWBS Rates Increased 

Researchers used linked administrative data to analyze temporal trends in monthly rates of ED and LWBS visits for adults in Ontario from 2014 to 2023.

They compared the composite outcome of 7-day all-cause mortality or hospitalization following an LWBS ED visit in April 2022‒March 2023 (recent period) with that following an LWBS ED visit in April 2014‒March 2020 (baseline period), after adjustment for age, sex, and Charlson Comorbidity Index (CCI).

In the two periods, patient characteristics were similar across age, sex, neighborhood-level income quartile, history of being unhoused, rurality, CCI, day, time, and mode of arrival. The median age was 40 years for the baseline period and 42 years for the recent period.

Temporal trends showed sustained increases in monthly LWBS rates after 2020, despite fewer monthly ED visits. The rate of LWBS ED visits after April 1, 2020, exceeded the baseline period’s single-month LWBS maximum of 4% in 15 of 36 months.

The rate of 7-day all-cause mortality or hospitalization was 3.4% in the recent period vs 2.9% in the baseline period (adjusted risk ratio [aRR], 1.14), despite similar rates of post-ED outpatient visits (7-day recent and baseline, 38.9% and 39.7%, respectively).

Similar trends were seen at 30 days for all-cause mortality or hospitalization (6.2% in the recent period vs 5.8% at baseline; aRR, 1.05) despite similar rates of post-ED outpatient visits (59.4% and 59.7%, respectively).

After April 1, 2020, monthly ED visits and the proportion of patients who LWBS varied widely.

The proportion of LWBS visits categorized as emergent on the Canadian Triage and Acuity Scale was higher during the recent period (12.9% vs 9.2% in the baseline period), and fewer visits were categorized as semiurgent (22.6% vs 31.9%, respectively). This finding suggested a higher acuity of illness among patients who LWBS in the recent period.

 

LWBS Visits ‘Not Benign’

Results of a preplanned subgroup analysis examining the risk for all-cause mortality after an LWBS visit were “particularly notable,” the authors wrote, with a 46% higher adjusted risk for death at 7 days and 24% higher adjusted risk at 30 days.

The observational study had several limitations, however. The authors could not draw conclusions regarding direct causes of the increased risk for severe short-term adverse health outcomes after an LWBS ED visit, and residual confounding is possible. Cause-of-death information was not available to generate hypotheses for future studies of potential causes. Furthermore, the findings may not be generalizable to systems without universal access to healthcare.

Nevertheless, the findings are a “concerning signal [and] should prompt interventions to address system- and population-level causes,” the authors wrote.

“Unfortunately, because of politics, since 2020, ED closures in Ontario have become more and more common and seem to be affecting more and more Ontarians,” said McNaughton. “It would be surprising if ED closure didn’t play some role in our findings.”

She added, “It is important to note that people in our study were relatively young, with a median age in their 40s; this makes our findings all the more concerning. Clinicians should be aware that LWBS ED visits are not necessarily benign, particularly when rates of LWBS ED visits are high.”

 

Unanswered Questions

The study raised the following questions that the authors are or will be investigating, according to McNaughton: 

• Which patients are at greatest risk for bad outcomes if they leave the ED without being seen, and why?
• How much of the findings might be related to recent ED closures, longer ED wait times, or other factors? Are there geographic variations in risk?
• What can be done in the ED to prevent LWBS ED visits, and what can be changed outside the ED to prevent LWBS ED visits? For example, what can hospitals do to reduce boarding in the ED? If patients leave without being seen, should they be contacted to try to meet their health needs in other ways?
• What worked in terms of maintaining access to outpatient medical care, despite the considerable disruptions starting in 2020, and how can continued success be ensured?

To address the current situation, McNaughton said, “We need consistent, predictable, and sustained investment in our public healthcare system. We need long-term, consistent funding for primary care, ED care, as well as hospital and long-term care.”

“It takes years to recruit and train the teams of people necessary to provide the high-quality medical care that Canadians have a right to. There are no shortcuts,” she concluded.

 

‘Tragic Situation’

American College of Emergency Physicians (ACEP) spokesperson Jesse Pines, MD, chief of clinical innovation at US Acute Care Solutions; clinical professor of emergency medicine at George Washington University in Washington, DC; and professor of emergency medicine at Drexel University in Philadelphia, commented on the study for this news organization.

“Similar to what the authors found in their report, LWBS and other metrics — specifically boarding — have progressively increased in the United States, in particular, since the early part of 2021,” he said. “The primary factor in the US driving this, and one that ACEP is trying to address on a national scale, is the boarding of admitted patients.”

When the number of boarded patients increases, there is less space in the ED for new patients, and waits increase, Pines explained. Some patients leave without being seen, and a subset of those patients experience poor outcomes. “It’s a tragic situation that is worsening.”

“Emergency physicians like me always worry when patients leave without being seen,” he said. While some of those patients have self-limited conditions that will improve on their own, “some have critical life-threatening conditions that require care and hospitalization. The worry is that these patients experience poorer outcomes,” Pines said. “The authors showed that this is increasingly the case in Canada. The same is likely true in the US.”

The study was funded by the Canadian Institutes of Health Research. McNaughton and Pines declared no relevant financial relationships.

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

Higher rates of leaving the emergency department (ED) without being seen are linked to increased short-term mortality or hospitalization, according to a cohort study in Ontario, Canada.

“We found that after 2020, there was a 14% higher risk for death or hospitalization within 7 days” among patients who left without being seen (LWBS), Candace McNaughton, MD, PhD, associate professor of medicine at the University of Toronto and scientist at Sunnybrook Research Institute, both in Toronto, Ontario, Canada, told this news organization.

“When we looked at death by itself, there was a 46% higher risk after 2020,” she said. “Even 30 days after a LWBS ED visit, there was still a 5% increased risk for death/hospitalization and a 24% increased risk for death.”

The study was published in the Journal of the American College of Emergency Physicians Open.

 

LWBS Rates Increased 

Researchers used linked administrative data to analyze temporal trends in monthly rates of ED and LWBS visits for adults in Ontario from 2014 to 2023.

They compared the composite outcome of 7-day all-cause mortality or hospitalization following an LWBS ED visit in April 2022‒March 2023 (recent period) with that following an LWBS ED visit in April 2014‒March 2020 (baseline period), after adjustment for age, sex, and Charlson Comorbidity Index (CCI).

In the two periods, patient characteristics were similar across age, sex, neighborhood-level income quartile, history of being unhoused, rurality, CCI, day, time, and mode of arrival. The median age was 40 years for the baseline period and 42 years for the recent period.

Temporal trends showed sustained increases in monthly LWBS rates after 2020, despite fewer monthly ED visits. The rate of LWBS ED visits after April 1, 2020, exceeded the baseline period’s single-month LWBS maximum of 4% in 15 of 36 months.

The rate of 7-day all-cause mortality or hospitalization was 3.4% in the recent period vs 2.9% in the baseline period (adjusted risk ratio [aRR], 1.14), despite similar rates of post-ED outpatient visits (7-day recent and baseline, 38.9% and 39.7%, respectively).

Similar trends were seen at 30 days for all-cause mortality or hospitalization (6.2% in the recent period vs 5.8% at baseline; aRR, 1.05) despite similar rates of post-ED outpatient visits (59.4% and 59.7%, respectively).

After April 1, 2020, monthly ED visits and the proportion of patients who LWBS varied widely.

The proportion of LWBS visits categorized as emergent on the Canadian Triage and Acuity Scale was higher during the recent period (12.9% vs 9.2% in the baseline period), and fewer visits were categorized as semiurgent (22.6% vs 31.9%, respectively). This finding suggested a higher acuity of illness among patients who LWBS in the recent period.

 

LWBS Visits ‘Not Benign’

Results of a preplanned subgroup analysis examining the risk for all-cause mortality after an LWBS visit were “particularly notable,” the authors wrote, with a 46% higher adjusted risk for death at 7 days and 24% higher adjusted risk at 30 days.

The observational study had several limitations, however. The authors could not draw conclusions regarding direct causes of the increased risk for severe short-term adverse health outcomes after an LWBS ED visit, and residual confounding is possible. Cause-of-death information was not available to generate hypotheses for future studies of potential causes. Furthermore, the findings may not be generalizable to systems without universal access to healthcare.

Nevertheless, the findings are a “concerning signal [and] should prompt interventions to address system- and population-level causes,” the authors wrote.

“Unfortunately, because of politics, since 2020, ED closures in Ontario have become more and more common and seem to be affecting more and more Ontarians,” said McNaughton. “It would be surprising if ED closure didn’t play some role in our findings.”

She added, “It is important to note that people in our study were relatively young, with a median age in their 40s; this makes our findings all the more concerning. Clinicians should be aware that LWBS ED visits are not necessarily benign, particularly when rates of LWBS ED visits are high.”

 

Unanswered Questions

The study raised the following questions that the authors are or will be investigating, according to McNaughton: 

• Which patients are at greatest risk for bad outcomes if they leave the ED without being seen, and why?
• How much of the findings might be related to recent ED closures, longer ED wait times, or other factors? Are there geographic variations in risk?
• What can be done in the ED to prevent LWBS ED visits, and what can be changed outside the ED to prevent LWBS ED visits? For example, what can hospitals do to reduce boarding in the ED? If patients leave without being seen, should they be contacted to try to meet their health needs in other ways?
• What worked in terms of maintaining access to outpatient medical care, despite the considerable disruptions starting in 2020, and how can continued success be ensured?

To address the current situation, McNaughton said, “We need consistent, predictable, and sustained investment in our public healthcare system. We need long-term, consistent funding for primary care, ED care, as well as hospital and long-term care.”

“It takes years to recruit and train the teams of people necessary to provide the high-quality medical care that Canadians have a right to. There are no shortcuts,” she concluded.

 

‘Tragic Situation’

American College of Emergency Physicians (ACEP) spokesperson Jesse Pines, MD, chief of clinical innovation at US Acute Care Solutions; clinical professor of emergency medicine at George Washington University in Washington, DC; and professor of emergency medicine at Drexel University in Philadelphia, commented on the study for this news organization.

“Similar to what the authors found in their report, LWBS and other metrics — specifically boarding — have progressively increased in the United States, in particular, since the early part of 2021,” he said. “The primary factor in the US driving this, and one that ACEP is trying to address on a national scale, is the boarding of admitted patients.”

When the number of boarded patients increases, there is less space in the ED for new patients, and waits increase, Pines explained. Some patients leave without being seen, and a subset of those patients experience poor outcomes. “It’s a tragic situation that is worsening.”

“Emergency physicians like me always worry when patients leave without being seen,” he said. While some of those patients have self-limited conditions that will improve on their own, “some have critical life-threatening conditions that require care and hospitalization. The worry is that these patients experience poorer outcomes,” Pines said. “The authors showed that this is increasingly the case in Canada. The same is likely true in the US.”

The study was funded by the Canadian Institutes of Health Research. McNaughton and Pines declared no relevant financial relationships.

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

Higher rates of leaving the emergency department (ED) without being seen are linked to increased short-term mortality or hospitalization, according to a cohort study in Ontario, Canada.

“We found that after 2020, there was a 14% higher risk for death or hospitalization within 7 days” among patients who left without being seen (LWBS), Candace McNaughton, MD, PhD, associate professor of medicine at the University of Toronto and scientist at Sunnybrook Research Institute, both in Toronto, Ontario, Canada, told this news organization.

“When we looked at death by itself, there was a 46% higher risk after 2020,” she said. “Even 30 days after a LWBS ED visit, there was still a 5% increased risk for death/hospitalization and a 24% increased risk for death.”

The study was published in the Journal of the American College of Emergency Physicians Open.

 

LWBS Rates Increased 

Researchers used linked administrative data to analyze temporal trends in monthly rates of ED and LWBS visits for adults in Ontario from 2014 to 2023.

They compared the composite outcome of 7-day all-cause mortality or hospitalization following an LWBS ED visit in April 2022‒March 2023 (recent period) with that following an LWBS ED visit in April 2014‒March 2020 (baseline period), after adjustment for age, sex, and Charlson Comorbidity Index (CCI).

In the two periods, patient characteristics were similar across age, sex, neighborhood-level income quartile, history of being unhoused, rurality, CCI, day, time, and mode of arrival. The median age was 40 years for the baseline period and 42 years for the recent period.

Temporal trends showed sustained increases in monthly LWBS rates after 2020, despite fewer monthly ED visits. The rate of LWBS ED visits after April 1, 2020, exceeded the baseline period’s single-month LWBS maximum of 4% in 15 of 36 months.

The rate of 7-day all-cause mortality or hospitalization was 3.4% in the recent period vs 2.9% in the baseline period (adjusted risk ratio [aRR], 1.14), despite similar rates of post-ED outpatient visits (7-day recent and baseline, 38.9% and 39.7%, respectively).

Similar trends were seen at 30 days for all-cause mortality or hospitalization (6.2% in the recent period vs 5.8% at baseline; aRR, 1.05) despite similar rates of post-ED outpatient visits (59.4% and 59.7%, respectively).

After April 1, 2020, monthly ED visits and the proportion of patients who LWBS varied widely.

The proportion of LWBS visits categorized as emergent on the Canadian Triage and Acuity Scale was higher during the recent period (12.9% vs 9.2% in the baseline period), and fewer visits were categorized as semiurgent (22.6% vs 31.9%, respectively). This finding suggested a higher acuity of illness among patients who LWBS in the recent period.

 

LWBS Visits ‘Not Benign’

Results of a preplanned subgroup analysis examining the risk for all-cause mortality after an LWBS visit were “particularly notable,” the authors wrote, with a 46% higher adjusted risk for death at 7 days and 24% higher adjusted risk at 30 days.

The observational study had several limitations, however. The authors could not draw conclusions regarding direct causes of the increased risk for severe short-term adverse health outcomes after an LWBS ED visit, and residual confounding is possible. Cause-of-death information was not available to generate hypotheses for future studies of potential causes. Furthermore, the findings may not be generalizable to systems without universal access to healthcare.

Nevertheless, the findings are a “concerning signal [and] should prompt interventions to address system- and population-level causes,” the authors wrote.

“Unfortunately, because of politics, since 2020, ED closures in Ontario have become more and more common and seem to be affecting more and more Ontarians,” said McNaughton. “It would be surprising if ED closure didn’t play some role in our findings.”

She added, “It is important to note that people in our study were relatively young, with a median age in their 40s; this makes our findings all the more concerning. Clinicians should be aware that LWBS ED visits are not necessarily benign, particularly when rates of LWBS ED visits are high.”

 

Unanswered Questions

The study raised the following questions that the authors are or will be investigating, according to McNaughton: 

• Which patients are at greatest risk for bad outcomes if they leave the ED without being seen, and why?
• How much of the findings might be related to recent ED closures, longer ED wait times, or other factors? Are there geographic variations in risk?
• What can be done in the ED to prevent LWBS ED visits, and what can be changed outside the ED to prevent LWBS ED visits? For example, what can hospitals do to reduce boarding in the ED? If patients leave without being seen, should they be contacted to try to meet their health needs in other ways?
• What worked in terms of maintaining access to outpatient medical care, despite the considerable disruptions starting in 2020, and how can continued success be ensured?

To address the current situation, McNaughton said, “We need consistent, predictable, and sustained investment in our public healthcare system. We need long-term, consistent funding for primary care, ED care, as well as hospital and long-term care.”

“It takes years to recruit and train the teams of people necessary to provide the high-quality medical care that Canadians have a right to. There are no shortcuts,” she concluded.

 

‘Tragic Situation’

American College of Emergency Physicians (ACEP) spokesperson Jesse Pines, MD, chief of clinical innovation at US Acute Care Solutions; clinical professor of emergency medicine at George Washington University in Washington, DC; and professor of emergency medicine at Drexel University in Philadelphia, commented on the study for this news organization.

“Similar to what the authors found in their report, LWBS and other metrics — specifically boarding — have progressively increased in the United States, in particular, since the early part of 2021,” he said. “The primary factor in the US driving this, and one that ACEP is trying to address on a national scale, is the boarding of admitted patients.”

When the number of boarded patients increases, there is less space in the ED for new patients, and waits increase, Pines explained. Some patients leave without being seen, and a subset of those patients experience poor outcomes. “It’s a tragic situation that is worsening.”

“Emergency physicians like me always worry when patients leave without being seen,” he said. While some of those patients have self-limited conditions that will improve on their own, “some have critical life-threatening conditions that require care and hospitalization. The worry is that these patients experience poorer outcomes,” Pines said. “The authors showed that this is increasingly the case in Canada. The same is likely true in the US.”

The study was funded by the Canadian Institutes of Health Research. McNaughton and Pines declared no relevant financial relationships.

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

TOPLINE: 

Among children with traumatic injury, those of Black ethnicity are more likely than those of White ethnicity to be suspected of experiencing child abuse. Young patients and those from low socioeconomic backgrounds also face an increased likelihood of suspicion for child abuse (SCA).

METHODOLOGY:

• Researchers analyzed data on pediatric patients admitted to hospitals after sustaining a traumatic injury between 2006 and 2016 using the Kids’ Inpatient Database (KID) to investigate racial and ethnic disparities in cases in which SCA codes from the 9th and 10th editions of the International Classification of Diseases were used.
• The analysis included a weighted total of 634,309 pediatric patients with complete data, comprising 13,579 patients in the SCA subgroup and 620,730 in the non-SCA subgroup.
• Patient demographics, injury severity, and hospitalization characteristics were classified by race and ethnicity.
• The primary outcome was differences in racial and ethnic composition between the SCA and non-SCA groups, as well as compared with the overall US population using 2010 US Census data.

TAKEAWAY:

• Black patients had 75% higher odds of having a SCA code, compared with White patients; the latter ethnicity was relatively underrepresented in the SCA subgroup, compared with the distribution reported by the US Census.
• Black patients had 10% higher odds of having a SCA code (odds ratio, 1.10; P =.004) than White patients, after socioeconomic factors such as insurance type, household income based on zip code, and injury severity were controlled for.
• Black patients in the SCA subgroup experienced a 26.5% (P < .001) longer hospital stay for mild to moderate injuries and a 40.1% (P < .001) longer stay for serious injuries compared with White patients.
• Patients in the SCA subgroup were significantly younger (mean, 1.70 years vs 9.70 years), were more likely to have Medicaid insurance (76.6% vs 42.0%), and had higher mortality rates (5.6% vs 1.0%) than those in the non-SCA subgroup; they were also more likely to come from lower socioeconomic backgrounds and present with more severe injuries.

IN PRACTICE:

“However, we can identify and appropriately respond to patients with potential child abuse in an equitable way by using clinical decision support tools, seeking clinical consultation of child abuse pediatricians, practicing cultural humility, and enhancing the education and training for health care professionals on child abuse recognition, response, and prevention,” Allison M. Jackson, MD, MPH, of the Child and Adolescent Protection Center at Children’s National Hospital, Washington, DC, wrote in an accompanying editorial.

SOURCE:

The study was led by Fereshteh Salimi-Jazi, MD, of Stanford University School of Medicine in California. It was published online on December 18, 2024, in JAMA Network Open.

LIMITATIONS: 

The study relied on data from KID, which has limitations such as potential coding errors and the inability to follow patients over time. The database combines race and ethnicity in a single field as well. The study only included hospitalized patients, which may not represent all clinician suspicions of SCA cases.

DISCLOSURES:

This study was supported by a grant from the National Center for Advancing Translational Sciences of the National Institutes of Health. The authors reported 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 appeared on Medscape.com.

TOPLINE: 

Among children with traumatic injury, those of Black ethnicity are more likely than those of White ethnicity to be suspected of experiencing child abuse. Young patients and those from low socioeconomic backgrounds also face an increased likelihood of suspicion for child abuse (SCA).

METHODOLOGY:

• Researchers analyzed data on pediatric patients admitted to hospitals after sustaining a traumatic injury between 2006 and 2016 using the Kids’ Inpatient Database (KID) to investigate racial and ethnic disparities in cases in which SCA codes from the 9th and 10th editions of the International Classification of Diseases were used.
• The analysis included a weighted total of 634,309 pediatric patients with complete data, comprising 13,579 patients in the SCA subgroup and 620,730 in the non-SCA subgroup.
• Patient demographics, injury severity, and hospitalization characteristics were classified by race and ethnicity.
• The primary outcome was differences in racial and ethnic composition between the SCA and non-SCA groups, as well as compared with the overall US population using 2010 US Census data.

TAKEAWAY:

• Black patients had 75% higher odds of having a SCA code, compared with White patients; the latter ethnicity was relatively underrepresented in the SCA subgroup, compared with the distribution reported by the US Census.
• Black patients had 10% higher odds of having a SCA code (odds ratio, 1.10; P =.004) than White patients, after socioeconomic factors such as insurance type, household income based on zip code, and injury severity were controlled for.
• Black patients in the SCA subgroup experienced a 26.5% (P < .001) longer hospital stay for mild to moderate injuries and a 40.1% (P < .001) longer stay for serious injuries compared with White patients.
• Patients in the SCA subgroup were significantly younger (mean, 1.70 years vs 9.70 years), were more likely to have Medicaid insurance (76.6% vs 42.0%), and had higher mortality rates (5.6% vs 1.0%) than those in the non-SCA subgroup; they were also more likely to come from lower socioeconomic backgrounds and present with more severe injuries.

IN PRACTICE:

“However, we can identify and appropriately respond to patients with potential child abuse in an equitable way by using clinical decision support tools, seeking clinical consultation of child abuse pediatricians, practicing cultural humility, and enhancing the education and training for health care professionals on child abuse recognition, response, and prevention,” Allison M. Jackson, MD, MPH, of the Child and Adolescent Protection Center at Children’s National Hospital, Washington, DC, wrote in an accompanying editorial.

SOURCE:

The study was led by Fereshteh Salimi-Jazi, MD, of Stanford University School of Medicine in California. It was published online on December 18, 2024, in JAMA Network Open.

LIMITATIONS: 

The study relied on data from KID, which has limitations such as potential coding errors and the inability to follow patients over time. The database combines race and ethnicity in a single field as well. The study only included hospitalized patients, which may not represent all clinician suspicions of SCA cases.

DISCLOSURES:

This study was supported by a grant from the National Center for Advancing Translational Sciences of the National Institutes of Health. The authors reported 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 appeared on Medscape.com.

TOPLINE: 

Among children with traumatic injury, those of Black ethnicity are more likely than those of White ethnicity to be suspected of experiencing child abuse. Young patients and those from low socioeconomic backgrounds also face an increased likelihood of suspicion for child abuse (SCA).

METHODOLOGY:

• Researchers analyzed data on pediatric patients admitted to hospitals after sustaining a traumatic injury between 2006 and 2016 using the Kids’ Inpatient Database (KID) to investigate racial and ethnic disparities in cases in which SCA codes from the 9th and 10th editions of the International Classification of Diseases were used.
• The analysis included a weighted total of 634,309 pediatric patients with complete data, comprising 13,579 patients in the SCA subgroup and 620,730 in the non-SCA subgroup.
• Patient demographics, injury severity, and hospitalization characteristics were classified by race and ethnicity.
• The primary outcome was differences in racial and ethnic composition between the SCA and non-SCA groups, as well as compared with the overall US population using 2010 US Census data.

TAKEAWAY:

• Black patients had 75% higher odds of having a SCA code, compared with White patients; the latter ethnicity was relatively underrepresented in the SCA subgroup, compared with the distribution reported by the US Census.
• Black patients had 10% higher odds of having a SCA code (odds ratio, 1.10; P =.004) than White patients, after socioeconomic factors such as insurance type, household income based on zip code, and injury severity were controlled for.
• Black patients in the SCA subgroup experienced a 26.5% (P < .001) longer hospital stay for mild to moderate injuries and a 40.1% (P < .001) longer stay for serious injuries compared with White patients.
• Patients in the SCA subgroup were significantly younger (mean, 1.70 years vs 9.70 years), were more likely to have Medicaid insurance (76.6% vs 42.0%), and had higher mortality rates (5.6% vs 1.0%) than those in the non-SCA subgroup; they were also more likely to come from lower socioeconomic backgrounds and present with more severe injuries.

IN PRACTICE:

“However, we can identify and appropriately respond to patients with potential child abuse in an equitable way by using clinical decision support tools, seeking clinical consultation of child abuse pediatricians, practicing cultural humility, and enhancing the education and training for health care professionals on child abuse recognition, response, and prevention,” Allison M. Jackson, MD, MPH, of the Child and Adolescent Protection Center at Children’s National Hospital, Washington, DC, wrote in an accompanying editorial.

SOURCE:

The study was led by Fereshteh Salimi-Jazi, MD, of Stanford University School of Medicine in California. It was published online on December 18, 2024, in JAMA Network Open.

LIMITATIONS: 

The study relied on data from KID, which has limitations such as potential coding errors and the inability to follow patients over time. The database combines race and ethnicity in a single field as well. The study only included hospitalized patients, which may not represent all clinician suspicions of SCA cases.

DISCLOSURES:

This study was supported by a grant from the National Center for Advancing Translational Sciences of the National Institutes of Health. The authors reported 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 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.

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.

This video transcript has been edited for clarity. 

Robert D. Glatter, MD: Hi and welcome. I’m Dr. Robert Glatter, medical adviser for Medscape Emergency Medicine. Joining me today to discuss a novel, plant-based approach to stopping moderate to severe bleeding is Joe Landolina, CEO and cofounder of Cresilon. Welcome, Joe. 

Joe Landolina, MS: Thank you so much for taking the time. It’s great to be here.

Educational Background and Inception of Cresilon

Glatter: It’s a pleasure to have you join me, and I want to congratulate you on your recent 510(k) FDA clearance for your novel product to save lives and stop bleeding. To begin with, can you explain how the idea for launching your company came about? 

Landolina: The way that Cresilon came about was a little bit unorthodox, because I was 17 years old when I invented the technology behind the product that eventually became Traumagel®. 

My grandfather was an ex-pharmaceutical executive, who later in life started a vineyard. I grew up on a vineyard with a winery chemistry lab across the street from my house and a grandfather who learned lab safety in the 60s. So, that meant that the day I learned how to walk, I was tossed into a lab and I fell head over heels in love with lab research.

That started experimentation and my academic pursuits. That led to discovering a blend of two plant-based polymers derived from algae that stop bleeding on contact, effectively creating a mechanical barrier and allowing anything from a gunshot wound to anything quite a bit more minor to stop in a matter of seconds.

Glatter: Your background is in biomedical engineering. How is it that you started tinkering and doing all this type of work? 

Landolina: That’s correct. I did my undergrad in chemical engineering, and my graduate studies were in biomedical engineering. For me, that was supposed to be a pathway into medical school. I always wanted to be a surgeon myself, and I love the field of medicine. 

As a freshman in college at NYU Engineering, I had this idea. I entered it into NYU’s business plan competition, and we won at the engineering school. That gave us just enough capital to start developing and researching Traumagel more, and Cresilon was born out of that research.

 

Techniques for Stopping Hemorrhage

Glatter: In terms of stopping hemorrhage, which takes so many lives in the United States and globally — certainly, uncontrolled hemorrhage — what are the techniques that you see, prior to the arrival of your product, as being effective? Can you elucidate some of these techniques? 

Landolina: In emergency medicine, the primary mode of controlling hemorrhage is passive. It’s what, in Brooklyn, we like to call “pressure and a prayer”, where you have a material that’s either gauze or an impregnated gauze in most cases, where the mode of action is absorbing blood, with the adjunct of pressure by the first responder or by the clinician who’s providing aid.

The idea is to stop the flow of blood to concentrate blood factors at the surface of the gauze product, and to promote either platelet activation or the production of fibrin to create a clot. 

These types of technologies are widespread. There are many versions of this technology carried by EMS agencies, trauma bays, US military soldiers, and soldiers across NATO countries. But these types of technologies tend to be relatively inefficient, meaning that they’re very difficult to get into wounds because of the gauze or the powder form of the devices, and it’s very hard to get them in contact with the form of bleeding.

On top of that, if the patient is clotting compromised or immunocompromised in some way, the ability to create a durable clot that will not be ripped off when you remove the product at the next level of care is also of concern. And so, this type of technology or the type of treatment of massive hemorrhage hasn’t changed in decades.

 

Current Applications and Potential Use

Glatter: I envision this product will be carried by paramedics, used on the battlefield at some point after your FDA clearance, and recently it went through.

Do you see any possibility that this could be an AED equivalent to Stop the Bleed? In other words, could the average lay person be trained to use your product if kits are available? 

Landolina: To be very clear, Traumagel today is only approved or cleared under a “prescription-only” indication, which means that it will not initially be available OTC. However, that is our goal. Our goal is to make this product available and usable by someone with no medical training whatsoever. 

The form factor of being a gel in a syringe lends itself well to that, meaning that we try to make it as easy as point and shoot to control hemorrhage, where there’s not as much technique to be learned in the application of a product like Traumagel as there is in current hemorrhage control techniques. 

 

Mechanism of Action and Physiology

Glatter: Once you apply Traumagel, can you explain what happens to the product after it’s applied and the bleeding has stopped? Does it get reabsorbed by the body? What’s the process here? 

Landolina: Under Traumagel’s indication, because it’s used in traumatic injury, it must be removed within 24 hours.

One of the big benefits of Traumagel is that when the patient produces a blood clot underneath Traumagel, it doesn’t become incorporated within the gel itself. To contrast that with the use of gauze, gauze is porous. The clot ends up wrapped around the fibers of the gauze, so if you peel the gauze away, it’s very likely that clot is coming off with it. The surgeon or the clinician at the next level of care is going to have to deal with the re-bleed. 

You can remove Traumagel cleanly and entirely without disturbing the underlying clot. That’s a major benefit, not only to the patient but also to the next level of care, to the next clinician or physician that is required to remove the product.

Glatter: How is it possible to remove the substance without disturbing the clot? Can you explain in more detail? 

Landolina: That’s one of the hallmarks of these plant-based polymers and the way that we design Traumagel itself. Traumagel is completely nonporous, and it has no fibrous nature to it. What that means is when the patient produces a blood clot or fibrin next to or on top of Traumagel, that fibrin ends up not incorporated within the polymers of Traumagel itself. 

Over time, because Traumagel is a hydrogel, meaning that by weight it’s mostly water, you end up having less adhesion to the clot over time. When it’s time to remove Traumagel from the injury, it has lost almost all of its adhesive capabilities, meaning that when you peel it away, that clot is going to stick better to tissue than it will to the gel itself. 

Glatter: Can you explain a little bit about the matrix that’s formed, the physiology, and how the polymers work to form this matrix? 

Landolina: Sure. Traumagel is made of two polysaccharides that are plant derived. One polysaccharide is polyanionic, and the other is polycationic, meaning one has negative charges and the other has positive charges, which together create almost a Lego block effect, where when the material comes in contact with tissue, it adheres strongly and allows for itself to effectively create a mechanical barrier against bleeding.

Courtesy of Cresilon

Landolina: Even in the face of major arterial blood flow, Traumagel will stay where it needs to stay, and it’s not going to get washed away. This means that it is much more easily appliable to these types of surfaces and will allow the patient to produce their own endogenous fibrin clot at that location.

Like I mentioned before, when that fibrin clot is formed, because the gel itself has no pores or fibers, it doesn’t become incorporated within the fibrin clot. You can take the gel away, leaving that clot behind without the chance of a rebleed.

 

Testing With Major Bleeds

Glatter: In terms of bleeding itself, have you tested your product with major aortic bleeds or carotid bleeds in preclinical work?

Landolina: We have used the US military’s model for lethal hemorrhage, and the idea there is to create a model that is just that — lethal. These are the worst types of bleeds that you can possibly imagine, where the patients are clotting compromised, and where you have, in most cases, a very strong arterial component, so something like a femoral artery bleed.

We’ve also tested in carotid artery, aortic applications, as well as combinations of venous and arterial bleeds. The idea here is to show the use of the product in the absolute worst-case scenario so that when this translates into the clinic, the models that we’ve used for evaluation, hopefully, are worse than what actually rolls into the trauma bay.

Glatter: Excellent. What’s the mean time to stop an arterial vs a venous bleed? Are we talking a matter of seconds?

Landolina: In the case of a healthy patient, meaning a patient without clotting compromise, you’re in a matter of seconds. It’s less than 10 seconds. 

In the case where you have clotting compromise, a deep, complicated wound geometry, we recommend holding a pressure bandage on for 3 minutes just because it increases the chance of Traumagel coming into contact with the bleed, especially when you can’t visualize the bleed in the bleed source. Because of that pressure time, that becomes the mean. But again, it’s highly dependent on the type of bleed and the style of application.

 

Failure Rates and Effectiveness

Glatter: As a segue to that, what is the failure rate based on your studies and internal research using Traumagel? Have there been cases where bleeding has not been able to be stopped? 

Landolina: It depends on the study, but the failure rates are incredibly low with Traumagel, assuming that it’s correctly used. That’s one of the benefits to this product, where with proper technique, with overwrap with gauze, you nearly always get control of hemorrhage with a product like this. 

Glatter: Is manual pressure required in that sense? From what you described earlier, manual pressure would not be required. 

Landolina: It depends on the injury. What we recommend is that, if you have a very deep wound where you cannot visualize the source of bleed, you use pressure to seat Traumagel into the source of bleeding, meaning that you’re following Committee on Tactical Combat Casualty Care (Co-TCCC) regulations or requirements, where you’re over wrapping with gauze, and you’re providing a pressure wrapping to ensure that the Traumagel is in contact with the bleed while it’s doing what it’s doing. 

In most cases, it doesn’t hurt to apply pressure on top of Traumagel as well. In more surface level bleeds, you don’t need pressure at all. 

 

Applications Beyond Trauma

Glatter: Interesting. In terms of further applications (eg, nose bleeds or GYN bleeding, which are life-threatening), do you see this coming as an application for the future? 

Landolina: That’s where we’re working. Traumagel is the successor to an animal health product called Vetigel. The formulations of the gel behind Vetigel and Traumagel are identical. Vetigel has a full surgical indication, and that’s everything from epistaxis to neuro and spine procedures, into cardiovascular and soft tissue surgeries, orthopedic medicine, and so on.

Cresilon’s goal is to eventually expand the indication of our technology to include surgical indications and other indications where we can help any patient that’s bleeding. 

Glatter: That’s important, because we use prehospital whole blood, low titer, specifically, when patients have life-threatening hemorrhage. With your product, that would reduce the amount of blood products that would need to be administered. This could be a real game changer. 

Landolina: Definitely, that’s the goal we’re working on. 

Infection Risks and Biocompatibility

Glatter: In terms of any risk for infection, has that been studied as well? Does Traumagel in any way lead to increased rates of infection?

Landolina: Traumagel is biocompatible. It’s a sterile product. We’ve done the full suite of biocompatibility testing as required by FDA. On top of that, remember that Vetigel, which is the same formulation, is an implantable product. As a result, that has even extended biocompatibility testing beyond what would be necessary for an external product.

In Vetigel’s use case, which has been used now in over 60,000 patients, primarily companion animals, dogs and cats, we haven’t seen instances of infection. There’s no reason to believe that we would see that clinically with Traumagel.

 

Research Collaborations and Future Applications

Glatter: In terms of other research that your company’s embarked on preclinically, I understand there were some studies done at Walter Reed Army Institute of Research. I was wondering if you could expand on these, specifically, in terms of traumatic brain injury (TBI) and hemorrhage related to that. For example, with shrapnel or even a gunshot wound. 

Landolina: The Walter Reed collaboration with Cresilon is something that I’m particularly excited about, because it marks Cresilon’s first project that’s outside the scope of just hemostasis. Walter Reed came to us with this proposal where there’s a big challenge in a subset of TBI called penetrating ballistic-like brain injury, where the brain has been penetrated by a bullet, shrapnel, or some other projectile, and there’s an injury that exposes the brain to the outside. 

Today, there is no standard of care to treat patients with those types of injuries. In many cases, mortality is caused through swelling of the brain, or collapse of the brain. What they came to us with was the potential of using our technology, not primarily as a hemostatic agent, but to be able to stabilize that patient enough to get to the next level of care to be treated by a neurosurgeon.

That study Walter Reed did was just a pilot that was done in small animals. In that pilot, they showed that over the period of treatment, there was no negative change in vital signs, no increase in edema or in swelling, or in any of the biomarkers that were being monitored at that time. 

At the very least, this is not full indication that this indication will work for Cresilon, but it shows that there’s promise. It’s something that we’re working on and hopefully we’ll be able to bring to market soon.

Glatter: Certainly, maintaining intracranial pressure and cerebral perfusion pressures are very critical. In the future, do you think this product would be able to be deployed endovascularly? Imagine this in terms of stopping bleeding from some source, whether it’s from a stroke or another intracranial source. 

Landolina: That’s been an area of interest for us. We have no evidence to prove that indication works at this point, but there’s also nothing to say that it wouldn’t be possible for our technology. At this point, we’ve only looked at a cursory level at those indications. 

Glatter: Does the use of Traumagel obviate the need for a more definitive repair (eg, with sutures) or something that’s more permanent?

Landolina: I always say that Traumagel — and Vetigel, for that matter — is not a replacement for good surgical technique. The surgeon always needs to make his or her best judgment when reviewing the patient. That doesn’t mean that there won’t need to be sutures or vascular repair in most of these cases, especially in major trauma.

Final Takeaways

Glatter: Do you have some bullet points or pearls you could give our audience as a takeaway? 

Landolina: When Cresilon looks at Traumagel — and for us, Traumagel is the next generation of hemostatic agent, especially in trauma care and in emergency medicine — it allows for a far-simplified application of the product and much faster control of hemorrhage with better patient outcomes.

As we roll this out through EMS agencies, trauma hospitals, military agencies, and eventually to the general public through a future indication, it’s something we’re very excited about. Personally, I started this business 14 years ago, and so it’s great to see our mission of saving lives transitioning to saving human lives.

Glatter: I look forward to seeing this product in the emergency department, but also in other settings, such as in the operating room where we can really help patients who are dying from hemorrhage, certainly on the battlefield, and the lay public. If someone were to come upon a patient who’s bleeding out, this could be certainly a game changer and a lifesaver. 

I want to thank you for your time. This is a really important product that’s transformed the lives of so many animals, but also people in the future.

Dr. Glatter is an assistant professor of emergency medicine at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. He reported no relevant conflicts of interest. Mr. Landolina is the CEO and co-founder of Cresilon, a biotechnology company specializing in plant-based solutions for emergency bleeding control.

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

This video transcript has been edited for clarity. 

Robert D. Glatter, MD: Hi and welcome. I’m Dr. Robert Glatter, medical adviser for Medscape Emergency Medicine. Joining me today to discuss a novel, plant-based approach to stopping moderate to severe bleeding is Joe Landolina, CEO and cofounder of Cresilon. Welcome, Joe. 

Joe Landolina, MS: Thank you so much for taking the time. It’s great to be here.

Educational Background and Inception of Cresilon

Glatter: It’s a pleasure to have you join me, and I want to congratulate you on your recent 510(k) FDA clearance for your novel product to save lives and stop bleeding. To begin with, can you explain how the idea for launching your company came about? 

Landolina: The way that Cresilon came about was a little bit unorthodox, because I was 17 years old when I invented the technology behind the product that eventually became Traumagel®. 

My grandfather was an ex-pharmaceutical executive, who later in life started a vineyard. I grew up on a vineyard with a winery chemistry lab across the street from my house and a grandfather who learned lab safety in the 60s. So, that meant that the day I learned how to walk, I was tossed into a lab and I fell head over heels in love with lab research.

That started experimentation and my academic pursuits. That led to discovering a blend of two plant-based polymers derived from algae that stop bleeding on contact, effectively creating a mechanical barrier and allowing anything from a gunshot wound to anything quite a bit more minor to stop in a matter of seconds.

Glatter: Your background is in biomedical engineering. How is it that you started tinkering and doing all this type of work? 

Landolina: That’s correct. I did my undergrad in chemical engineering, and my graduate studies were in biomedical engineering. For me, that was supposed to be a pathway into medical school. I always wanted to be a surgeon myself, and I love the field of medicine. 

As a freshman in college at NYU Engineering, I had this idea. I entered it into NYU’s business plan competition, and we won at the engineering school. That gave us just enough capital to start developing and researching Traumagel more, and Cresilon was born out of that research.

 

Techniques for Stopping Hemorrhage

Glatter: In terms of stopping hemorrhage, which takes so many lives in the United States and globally — certainly, uncontrolled hemorrhage — what are the techniques that you see, prior to the arrival of your product, as being effective? Can you elucidate some of these techniques? 

Landolina: In emergency medicine, the primary mode of controlling hemorrhage is passive. It’s what, in Brooklyn, we like to call “pressure and a prayer”, where you have a material that’s either gauze or an impregnated gauze in most cases, where the mode of action is absorbing blood, with the adjunct of pressure by the first responder or by the clinician who’s providing aid.

The idea is to stop the flow of blood to concentrate blood factors at the surface of the gauze product, and to promote either platelet activation or the production of fibrin to create a clot. 

These types of technologies are widespread. There are many versions of this technology carried by EMS agencies, trauma bays, US military soldiers, and soldiers across NATO countries. But these types of technologies tend to be relatively inefficient, meaning that they’re very difficult to get into wounds because of the gauze or the powder form of the devices, and it’s very hard to get them in contact with the form of bleeding.

On top of that, if the patient is clotting compromised or immunocompromised in some way, the ability to create a durable clot that will not be ripped off when you remove the product at the next level of care is also of concern. And so, this type of technology or the type of treatment of massive hemorrhage hasn’t changed in decades.

 

Current Applications and Potential Use

Glatter: I envision this product will be carried by paramedics, used on the battlefield at some point after your FDA clearance, and recently it went through.

Do you see any possibility that this could be an AED equivalent to Stop the Bleed? In other words, could the average lay person be trained to use your product if kits are available? 

Landolina: To be very clear, Traumagel today is only approved or cleared under a “prescription-only” indication, which means that it will not initially be available OTC. However, that is our goal. Our goal is to make this product available and usable by someone with no medical training whatsoever. 

The form factor of being a gel in a syringe lends itself well to that, meaning that we try to make it as easy as point and shoot to control hemorrhage, where there’s not as much technique to be learned in the application of a product like Traumagel as there is in current hemorrhage control techniques. 

 

Mechanism of Action and Physiology

Glatter: Once you apply Traumagel, can you explain what happens to the product after it’s applied and the bleeding has stopped? Does it get reabsorbed by the body? What’s the process here? 

Landolina: Under Traumagel’s indication, because it’s used in traumatic injury, it must be removed within 24 hours.

One of the big benefits of Traumagel is that when the patient produces a blood clot underneath Traumagel, it doesn’t become incorporated within the gel itself. To contrast that with the use of gauze, gauze is porous. The clot ends up wrapped around the fibers of the gauze, so if you peel the gauze away, it’s very likely that clot is coming off with it. The surgeon or the clinician at the next level of care is going to have to deal with the re-bleed. 

You can remove Traumagel cleanly and entirely without disturbing the underlying clot. That’s a major benefit, not only to the patient but also to the next level of care, to the next clinician or physician that is required to remove the product.

Glatter: How is it possible to remove the substance without disturbing the clot? Can you explain in more detail? 

Landolina: That’s one of the hallmarks of these plant-based polymers and the way that we design Traumagel itself. Traumagel is completely nonporous, and it has no fibrous nature to it. What that means is when the patient produces a blood clot or fibrin next to or on top of Traumagel, that fibrin ends up not incorporated within the polymers of Traumagel itself. 

Over time, because Traumagel is a hydrogel, meaning that by weight it’s mostly water, you end up having less adhesion to the clot over time. When it’s time to remove Traumagel from the injury, it has lost almost all of its adhesive capabilities, meaning that when you peel it away, that clot is going to stick better to tissue than it will to the gel itself. 

Glatter: Can you explain a little bit about the matrix that’s formed, the physiology, and how the polymers work to form this matrix? 

Landolina: Sure. Traumagel is made of two polysaccharides that are plant derived. One polysaccharide is polyanionic, and the other is polycationic, meaning one has negative charges and the other has positive charges, which together create almost a Lego block effect, where when the material comes in contact with tissue, it adheres strongly and allows for itself to effectively create a mechanical barrier against bleeding.

Courtesy of Cresilon

Landolina: Even in the face of major arterial blood flow, Traumagel will stay where it needs to stay, and it’s not going to get washed away. This means that it is much more easily appliable to these types of surfaces and will allow the patient to produce their own endogenous fibrin clot at that location.

Like I mentioned before, when that fibrin clot is formed, because the gel itself has no pores or fibers, it doesn’t become incorporated within the fibrin clot. You can take the gel away, leaving that clot behind without the chance of a rebleed.

 

Testing With Major Bleeds

Glatter: In terms of bleeding itself, have you tested your product with major aortic bleeds or carotid bleeds in preclinical work?

Landolina: We have used the US military’s model for lethal hemorrhage, and the idea there is to create a model that is just that — lethal. These are the worst types of bleeds that you can possibly imagine, where the patients are clotting compromised, and where you have, in most cases, a very strong arterial component, so something like a femoral artery bleed.

We’ve also tested in carotid artery, aortic applications, as well as combinations of venous and arterial bleeds. The idea here is to show the use of the product in the absolute worst-case scenario so that when this translates into the clinic, the models that we’ve used for evaluation, hopefully, are worse than what actually rolls into the trauma bay.

Glatter: Excellent. What’s the mean time to stop an arterial vs a venous bleed? Are we talking a matter of seconds?

Landolina: In the case of a healthy patient, meaning a patient without clotting compromise, you’re in a matter of seconds. It’s less than 10 seconds. 

In the case where you have clotting compromise, a deep, complicated wound geometry, we recommend holding a pressure bandage on for 3 minutes just because it increases the chance of Traumagel coming into contact with the bleed, especially when you can’t visualize the bleed in the bleed source. Because of that pressure time, that becomes the mean. But again, it’s highly dependent on the type of bleed and the style of application.

 

Failure Rates and Effectiveness

Glatter: As a segue to that, what is the failure rate based on your studies and internal research using Traumagel? Have there been cases where bleeding has not been able to be stopped? 

Landolina: It depends on the study, but the failure rates are incredibly low with Traumagel, assuming that it’s correctly used. That’s one of the benefits to this product, where with proper technique, with overwrap with gauze, you nearly always get control of hemorrhage with a product like this. 

Glatter: Is manual pressure required in that sense? From what you described earlier, manual pressure would not be required. 

Landolina: It depends on the injury. What we recommend is that, if you have a very deep wound where you cannot visualize the source of bleed, you use pressure to seat Traumagel into the source of bleeding, meaning that you’re following Committee on Tactical Combat Casualty Care (Co-TCCC) regulations or requirements, where you’re over wrapping with gauze, and you’re providing a pressure wrapping to ensure that the Traumagel is in contact with the bleed while it’s doing what it’s doing. 

In most cases, it doesn’t hurt to apply pressure on top of Traumagel as well. In more surface level bleeds, you don’t need pressure at all. 

 

Applications Beyond Trauma

Glatter: Interesting. In terms of further applications (eg, nose bleeds or GYN bleeding, which are life-threatening), do you see this coming as an application for the future? 

Landolina: That’s where we’re working. Traumagel is the successor to an animal health product called Vetigel. The formulations of the gel behind Vetigel and Traumagel are identical. Vetigel has a full surgical indication, and that’s everything from epistaxis to neuro and spine procedures, into cardiovascular and soft tissue surgeries, orthopedic medicine, and so on.

Cresilon’s goal is to eventually expand the indication of our technology to include surgical indications and other indications where we can help any patient that’s bleeding. 

Glatter: That’s important, because we use prehospital whole blood, low titer, specifically, when patients have life-threatening hemorrhage. With your product, that would reduce the amount of blood products that would need to be administered. This could be a real game changer. 

Landolina: Definitely, that’s the goal we’re working on. 

Infection Risks and Biocompatibility

Glatter: In terms of any risk for infection, has that been studied as well? Does Traumagel in any way lead to increased rates of infection?

Landolina: Traumagel is biocompatible. It’s a sterile product. We’ve done the full suite of biocompatibility testing as required by FDA. On top of that, remember that Vetigel, which is the same formulation, is an implantable product. As a result, that has even extended biocompatibility testing beyond what would be necessary for an external product.

In Vetigel’s use case, which has been used now in over 60,000 patients, primarily companion animals, dogs and cats, we haven’t seen instances of infection. There’s no reason to believe that we would see that clinically with Traumagel.

 

Research Collaborations and Future Applications

Glatter: In terms of other research that your company’s embarked on preclinically, I understand there were some studies done at Walter Reed Army Institute of Research. I was wondering if you could expand on these, specifically, in terms of traumatic brain injury (TBI) and hemorrhage related to that. For example, with shrapnel or even a gunshot wound. 

Landolina: The Walter Reed collaboration with Cresilon is something that I’m particularly excited about, because it marks Cresilon’s first project that’s outside the scope of just hemostasis. Walter Reed came to us with this proposal where there’s a big challenge in a subset of TBI called penetrating ballistic-like brain injury, where the brain has been penetrated by a bullet, shrapnel, or some other projectile, and there’s an injury that exposes the brain to the outside. 

Today, there is no standard of care to treat patients with those types of injuries. In many cases, mortality is caused through swelling of the brain, or collapse of the brain. What they came to us with was the potential of using our technology, not primarily as a hemostatic agent, but to be able to stabilize that patient enough to get to the next level of care to be treated by a neurosurgeon.

That study Walter Reed did was just a pilot that was done in small animals. In that pilot, they showed that over the period of treatment, there was no negative change in vital signs, no increase in edema or in swelling, or in any of the biomarkers that were being monitored at that time. 

At the very least, this is not full indication that this indication will work for Cresilon, but it shows that there’s promise. It’s something that we’re working on and hopefully we’ll be able to bring to market soon.

Glatter: Certainly, maintaining intracranial pressure and cerebral perfusion pressures are very critical. In the future, do you think this product would be able to be deployed endovascularly? Imagine this in terms of stopping bleeding from some source, whether it’s from a stroke or another intracranial source. 

Landolina: That’s been an area of interest for us. We have no evidence to prove that indication works at this point, but there’s also nothing to say that it wouldn’t be possible for our technology. At this point, we’ve only looked at a cursory level at those indications. 

Glatter: Does the use of Traumagel obviate the need for a more definitive repair (eg, with sutures) or something that’s more permanent?

Landolina: I always say that Traumagel — and Vetigel, for that matter — is not a replacement for good surgical technique. The surgeon always needs to make his or her best judgment when reviewing the patient. That doesn’t mean that there won’t need to be sutures or vascular repair in most of these cases, especially in major trauma.

Final Takeaways

Glatter: Do you have some bullet points or pearls you could give our audience as a takeaway? 

Landolina: When Cresilon looks at Traumagel — and for us, Traumagel is the next generation of hemostatic agent, especially in trauma care and in emergency medicine — it allows for a far-simplified application of the product and much faster control of hemorrhage with better patient outcomes.

As we roll this out through EMS agencies, trauma hospitals, military agencies, and eventually to the general public through a future indication, it’s something we’re very excited about. Personally, I started this business 14 years ago, and so it’s great to see our mission of saving lives transitioning to saving human lives.

Glatter: I look forward to seeing this product in the emergency department, but also in other settings, such as in the operating room where we can really help patients who are dying from hemorrhage, certainly on the battlefield, and the lay public. If someone were to come upon a patient who’s bleeding out, this could be certainly a game changer and a lifesaver. 

I want to thank you for your time. This is a really important product that’s transformed the lives of so many animals, but also people in the future.

Dr. Glatter is an assistant professor of emergency medicine at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. He reported no relevant conflicts of interest. Mr. Landolina is the CEO and co-founder of Cresilon, a biotechnology company specializing in plant-based solutions for emergency bleeding control.

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

This video transcript has been edited for clarity. 

Robert D. Glatter, MD: Hi and welcome. I’m Dr. Robert Glatter, medical adviser for Medscape Emergency Medicine. Joining me today to discuss a novel, plant-based approach to stopping moderate to severe bleeding is Joe Landolina, CEO and cofounder of Cresilon. Welcome, Joe. 

Joe Landolina, MS: Thank you so much for taking the time. It’s great to be here.

Educational Background and Inception of Cresilon

Glatter: It’s a pleasure to have you join me, and I want to congratulate you on your recent 510(k) FDA clearance for your novel product to save lives and stop bleeding. To begin with, can you explain how the idea for launching your company came about? 

Landolina: The way that Cresilon came about was a little bit unorthodox, because I was 17 years old when I invented the technology behind the product that eventually became Traumagel®. 

My grandfather was an ex-pharmaceutical executive, who later in life started a vineyard. I grew up on a vineyard with a winery chemistry lab across the street from my house and a grandfather who learned lab safety in the 60s. So, that meant that the day I learned how to walk, I was tossed into a lab and I fell head over heels in love with lab research.

That started experimentation and my academic pursuits. That led to discovering a blend of two plant-based polymers derived from algae that stop bleeding on contact, effectively creating a mechanical barrier and allowing anything from a gunshot wound to anything quite a bit more minor to stop in a matter of seconds.

Glatter: Your background is in biomedical engineering. How is it that you started tinkering and doing all this type of work? 

Landolina: That’s correct. I did my undergrad in chemical engineering, and my graduate studies were in biomedical engineering. For me, that was supposed to be a pathway into medical school. I always wanted to be a surgeon myself, and I love the field of medicine. 

As a freshman in college at NYU Engineering, I had this idea. I entered it into NYU’s business plan competition, and we won at the engineering school. That gave us just enough capital to start developing and researching Traumagel more, and Cresilon was born out of that research.

 

Techniques for Stopping Hemorrhage

Glatter: In terms of stopping hemorrhage, which takes so many lives in the United States and globally — certainly, uncontrolled hemorrhage — what are the techniques that you see, prior to the arrival of your product, as being effective? Can you elucidate some of these techniques? 

Landolina: In emergency medicine, the primary mode of controlling hemorrhage is passive. It’s what, in Brooklyn, we like to call “pressure and a prayer”, where you have a material that’s either gauze or an impregnated gauze in most cases, where the mode of action is absorbing blood, with the adjunct of pressure by the first responder or by the clinician who’s providing aid.

The idea is to stop the flow of blood to concentrate blood factors at the surface of the gauze product, and to promote either platelet activation or the production of fibrin to create a clot. 

These types of technologies are widespread. There are many versions of this technology carried by EMS agencies, trauma bays, US military soldiers, and soldiers across NATO countries. But these types of technologies tend to be relatively inefficient, meaning that they’re very difficult to get into wounds because of the gauze or the powder form of the devices, and it’s very hard to get them in contact with the form of bleeding.

On top of that, if the patient is clotting compromised or immunocompromised in some way, the ability to create a durable clot that will not be ripped off when you remove the product at the next level of care is also of concern. And so, this type of technology or the type of treatment of massive hemorrhage hasn’t changed in decades.

 

Current Applications and Potential Use

Glatter: I envision this product will be carried by paramedics, used on the battlefield at some point after your FDA clearance, and recently it went through.

Do you see any possibility that this could be an AED equivalent to Stop the Bleed? In other words, could the average lay person be trained to use your product if kits are available? 

Landolina: To be very clear, Traumagel today is only approved or cleared under a “prescription-only” indication, which means that it will not initially be available OTC. However, that is our goal. Our goal is to make this product available and usable by someone with no medical training whatsoever. 

The form factor of being a gel in a syringe lends itself well to that, meaning that we try to make it as easy as point and shoot to control hemorrhage, where there’s not as much technique to be learned in the application of a product like Traumagel as there is in current hemorrhage control techniques. 

 

Mechanism of Action and Physiology

Glatter: Once you apply Traumagel, can you explain what happens to the product after it’s applied and the bleeding has stopped? Does it get reabsorbed by the body? What’s the process here? 

Landolina: Under Traumagel’s indication, because it’s used in traumatic injury, it must be removed within 24 hours.

One of the big benefits of Traumagel is that when the patient produces a blood clot underneath Traumagel, it doesn’t become incorporated within the gel itself. To contrast that with the use of gauze, gauze is porous. The clot ends up wrapped around the fibers of the gauze, so if you peel the gauze away, it’s very likely that clot is coming off with it. The surgeon or the clinician at the next level of care is going to have to deal with the re-bleed. 

You can remove Traumagel cleanly and entirely without disturbing the underlying clot. That’s a major benefit, not only to the patient but also to the next level of care, to the next clinician or physician that is required to remove the product.

Glatter: How is it possible to remove the substance without disturbing the clot? Can you explain in more detail? 

Landolina: That’s one of the hallmarks of these plant-based polymers and the way that we design Traumagel itself. Traumagel is completely nonporous, and it has no fibrous nature to it. What that means is when the patient produces a blood clot or fibrin next to or on top of Traumagel, that fibrin ends up not incorporated within the polymers of Traumagel itself. 

Over time, because Traumagel is a hydrogel, meaning that by weight it’s mostly water, you end up having less adhesion to the clot over time. When it’s time to remove Traumagel from the injury, it has lost almost all of its adhesive capabilities, meaning that when you peel it away, that clot is going to stick better to tissue than it will to the gel itself. 

Glatter: Can you explain a little bit about the matrix that’s formed, the physiology, and how the polymers work to form this matrix? 

Landolina: Sure. Traumagel is made of two polysaccharides that are plant derived. One polysaccharide is polyanionic, and the other is polycationic, meaning one has negative charges and the other has positive charges, which together create almost a Lego block effect, where when the material comes in contact with tissue, it adheres strongly and allows for itself to effectively create a mechanical barrier against bleeding.

Courtesy of Cresilon

Landolina: Even in the face of major arterial blood flow, Traumagel will stay where it needs to stay, and it’s not going to get washed away. This means that it is much more easily appliable to these types of surfaces and will allow the patient to produce their own endogenous fibrin clot at that location.

Like I mentioned before, when that fibrin clot is formed, because the gel itself has no pores or fibers, it doesn’t become incorporated within the fibrin clot. You can take the gel away, leaving that clot behind without the chance of a rebleed.

 

Testing With Major Bleeds

Glatter: In terms of bleeding itself, have you tested your product with major aortic bleeds or carotid bleeds in preclinical work?

Landolina: We have used the US military’s model for lethal hemorrhage, and the idea there is to create a model that is just that — lethal. These are the worst types of bleeds that you can possibly imagine, where the patients are clotting compromised, and where you have, in most cases, a very strong arterial component, so something like a femoral artery bleed.

We’ve also tested in carotid artery, aortic applications, as well as combinations of venous and arterial bleeds. The idea here is to show the use of the product in the absolute worst-case scenario so that when this translates into the clinic, the models that we’ve used for evaluation, hopefully, are worse than what actually rolls into the trauma bay.

Glatter: Excellent. What’s the mean time to stop an arterial vs a venous bleed? Are we talking a matter of seconds?

Landolina: In the case of a healthy patient, meaning a patient without clotting compromise, you’re in a matter of seconds. It’s less than 10 seconds. 

In the case where you have clotting compromise, a deep, complicated wound geometry, we recommend holding a pressure bandage on for 3 minutes just because it increases the chance of Traumagel coming into contact with the bleed, especially when you can’t visualize the bleed in the bleed source. Because of that pressure time, that becomes the mean. But again, it’s highly dependent on the type of bleed and the style of application.

 

Failure Rates and Effectiveness

Glatter: As a segue to that, what is the failure rate based on your studies and internal research using Traumagel? Have there been cases where bleeding has not been able to be stopped? 

Landolina: It depends on the study, but the failure rates are incredibly low with Traumagel, assuming that it’s correctly used. That’s one of the benefits to this product, where with proper technique, with overwrap with gauze, you nearly always get control of hemorrhage with a product like this. 

Glatter: Is manual pressure required in that sense? From what you described earlier, manual pressure would not be required. 

Landolina: It depends on the injury. What we recommend is that, if you have a very deep wound where you cannot visualize the source of bleed, you use pressure to seat Traumagel into the source of bleeding, meaning that you’re following Committee on Tactical Combat Casualty Care (Co-TCCC) regulations or requirements, where you’re over wrapping with gauze, and you’re providing a pressure wrapping to ensure that the Traumagel is in contact with the bleed while it’s doing what it’s doing. 

In most cases, it doesn’t hurt to apply pressure on top of Traumagel as well. In more surface level bleeds, you don’t need pressure at all. 

 

Applications Beyond Trauma

Glatter: Interesting. In terms of further applications (eg, nose bleeds or GYN bleeding, which are life-threatening), do you see this coming as an application for the future? 

Landolina: That’s where we’re working. Traumagel is the successor to an animal health product called Vetigel. The formulations of the gel behind Vetigel and Traumagel are identical. Vetigel has a full surgical indication, and that’s everything from epistaxis to neuro and spine procedures, into cardiovascular and soft tissue surgeries, orthopedic medicine, and so on.

Cresilon’s goal is to eventually expand the indication of our technology to include surgical indications and other indications where we can help any patient that’s bleeding. 

Glatter: That’s important, because we use prehospital whole blood, low titer, specifically, when patients have life-threatening hemorrhage. With your product, that would reduce the amount of blood products that would need to be administered. This could be a real game changer. 

Landolina: Definitely, that’s the goal we’re working on. 

Infection Risks and Biocompatibility

Glatter: In terms of any risk for infection, has that been studied as well? Does Traumagel in any way lead to increased rates of infection?

Landolina: Traumagel is biocompatible. It’s a sterile product. We’ve done the full suite of biocompatibility testing as required by FDA. On top of that, remember that Vetigel, which is the same formulation, is an implantable product. As a result, that has even extended biocompatibility testing beyond what would be necessary for an external product.

In Vetigel’s use case, which has been used now in over 60,000 patients, primarily companion animals, dogs and cats, we haven’t seen instances of infection. There’s no reason to believe that we would see that clinically with Traumagel.

 

Research Collaborations and Future Applications

Glatter: In terms of other research that your company’s embarked on preclinically, I understand there were some studies done at Walter Reed Army Institute of Research. I was wondering if you could expand on these, specifically, in terms of traumatic brain injury (TBI) and hemorrhage related to that. For example, with shrapnel or even a gunshot wound. 

Landolina: The Walter Reed collaboration with Cresilon is something that I’m particularly excited about, because it marks Cresilon’s first project that’s outside the scope of just hemostasis. Walter Reed came to us with this proposal where there’s a big challenge in a subset of TBI called penetrating ballistic-like brain injury, where the brain has been penetrated by a bullet, shrapnel, or some other projectile, and there’s an injury that exposes the brain to the outside. 

Today, there is no standard of care to treat patients with those types of injuries. In many cases, mortality is caused through swelling of the brain, or collapse of the brain. What they came to us with was the potential of using our technology, not primarily as a hemostatic agent, but to be able to stabilize that patient enough to get to the next level of care to be treated by a neurosurgeon.

That study Walter Reed did was just a pilot that was done in small animals. In that pilot, they showed that over the period of treatment, there was no negative change in vital signs, no increase in edema or in swelling, or in any of the biomarkers that were being monitored at that time. 

At the very least, this is not full indication that this indication will work for Cresilon, but it shows that there’s promise. It’s something that we’re working on and hopefully we’ll be able to bring to market soon.

Glatter: Certainly, maintaining intracranial pressure and cerebral perfusion pressures are very critical. In the future, do you think this product would be able to be deployed endovascularly? Imagine this in terms of stopping bleeding from some source, whether it’s from a stroke or another intracranial source. 

Landolina: That’s been an area of interest for us. We have no evidence to prove that indication works at this point, but there’s also nothing to say that it wouldn’t be possible for our technology. At this point, we’ve only looked at a cursory level at those indications. 

Glatter: Does the use of Traumagel obviate the need for a more definitive repair (eg, with sutures) or something that’s more permanent?

Landolina: I always say that Traumagel — and Vetigel, for that matter — is not a replacement for good surgical technique. The surgeon always needs to make his or her best judgment when reviewing the patient. That doesn’t mean that there won’t need to be sutures or vascular repair in most of these cases, especially in major trauma.

Final Takeaways

Glatter: Do you have some bullet points or pearls you could give our audience as a takeaway? 

Landolina: When Cresilon looks at Traumagel — and for us, Traumagel is the next generation of hemostatic agent, especially in trauma care and in emergency medicine — it allows for a far-simplified application of the product and much faster control of hemorrhage with better patient outcomes.

As we roll this out through EMS agencies, trauma hospitals, military agencies, and eventually to the general public through a future indication, it’s something we’re very excited about. Personally, I started this business 14 years ago, and so it’s great to see our mission of saving lives transitioning to saving human lives.

Glatter: I look forward to seeing this product in the emergency department, but also in other settings, such as in the operating room where we can really help patients who are dying from hemorrhage, certainly on the battlefield, and the lay public. If someone were to come upon a patient who’s bleeding out, this could be certainly a game changer and a lifesaver. 

I want to thank you for your time. This is a really important product that’s transformed the lives of so many animals, but also people in the future.

Dr. Glatter is an assistant professor of emergency medicine at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. He reported no relevant conflicts of interest. Mr. Landolina is the CEO and co-founder of Cresilon, a biotechnology company specializing in plant-based solutions for emergency bleeding control.

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

Approximately 1 in 20 adults with outpatient respiratory syncytial virus (RSV) infections were readmitted to the hospital within 28 days, based on new data from more than 67,000 cases.

RSV remains a top cause of acute respiratory tract infections among adults in the United States, with an estimated 159,000 hospitalizations in those aged 65 years or older, wrote Suzanne N. Landi, MPH, PhD, of Pfizer in New York City, and colleagues in a study published in JAMA Network Open.

“Currently, limited estimates exist to determine the risk of hospitalization following outpatient RSV disease diagnoses in the United States,” said corresponding author Joshua T. Swan, PharmD, MPH, in an interview.

The current study was conducted to inform development of clinical trials, said Swan, senior director and category clinician in internal medicine and disease development at Pfizer, the sponsor of the study. These trials would assess the efficacy of an outpatient RSV antiviral treatment in preventing RSV-related hospitalization within 28 days among adults at a high risk for progression to severe illness, he said.

The authors reviewed data from 67,239 adults aged 18 years or older with medically attended RSV infections between October 1, 2016, and September 30, 2022. The data came from three databases: Optum (2771 patients), TriNetX (7442 patients), and Veradigm Network Electronic Health Record (VNEHR; 57,026 patients).

The primary outcome was all-cause hospitalization within 28 days of medically attended RSV.

Overall, the proportions of patients hospitalized within 28 days of infection were 6.2%, 6.0%, and 4.5% in Optum, TriNetX, and VNEHR databases, respectively.

Approximately two thirds of the patients (62%-67% across the three databases) were women, and 14.0%-54.5% were aged 65 years or older. The researchers also identified comorbidity prevalences of 20.0%-30.5% for chronic obstructive pulmonary disease (COPD), 14.6%-24.4% for heart failure (HF), and 14.6%-24.4% for asthma.

A majority of the patients (ranging from 74.5% to 90.6% across the three databases) fell into a high-risk subgroup, defined as age 65 years or older with asthma, COPD, and HF. In this high-risk group, the proportions of hospitalizations were 7.6%, 8.5%, and 6.5% for Optum, TriNetX, and VNEHR, respectively.

The findings were limited by several factors, including the use only of data from outpatient settings, which cannot be used to estimate the RSV burden in the general population, and the reliance only on diagnosis or procedure codes to identify comorbidities, the researchers noted.

However, “the absolute risk of hospitalization of 1 out of 20 patients observed in our study represents significant and meaningful risk for vulnerable adults, in a disease where much of the public’s attention has historically focused on risk of hospitalization for young children,” Swan said. “These results highlight the unmet medical need for outpatient interventions and preventive measures that can reduce hospitalizations.” 

 

Don’t Underestimate RSV Impact

The current study highlights the fact that RSV is a major cause of respiratory viral illness, said David R. Manoff, MD, associate professor of clinical thoracic medicine and surgery at Temple University, Philadelphia, in an interview.

“Historically, influenza, and, more recently, COVID-19 infection have generally been thought of as more likely to cause harm and, thus, have been more emphasized in terms of both vaccination and treatment,” said Manoff, who was not involved in the study.

The current study provides new evidence that infection with RSV can be far more serious than often recognized and a major potential source of both hospitalization and morbidity, Manoff said. In fact, data published in Morbidity and Mortality Weekly Report in 2023 showed that the risks of needing oxygen, intensive care unit (ICU) admission, intubation, and death were actually higher in patients hospitalized with RSV infections than in those hospitalized with influenza or COVID-19. “

Understanding which population is hospitalized in the first place is vital to targeting prevention measures,” he added.

The new data are consistent with previous studies showing that most patients with RSV infection have primarily upper respiratory tract infection–type symptoms, but that a minority will develop lower respiratory tract disease, Manoff noted.

The findings add to the argument for implementation of RSV vaccination, especially in high-risk individuals, and support the need for RSV testing when patients present for care, he said.

However, more research is needed to reflect recent numbers, Manoff said. The study timeframe of 2016-2022 not only precedes commercially available RSV vaccines but also includes the period of increased isolation and masking seen during the COVID-19 pandemic years of 2020-2021. “We need to see if the same trends continue in the post-pandemic era.” 

Additionally, the studies leading to approval of the RSV vaccine showed a reduction in hospitalization with RSV, and it is important to see how this reduction translates in real-world data and whether the RSV vaccines are reducing need for ICU admission, intubation, and death, Manoff said.

The study was funded by Pfizer, and Swan is a Pfizer employee. Manoff had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Approximately 1 in 20 adults with outpatient respiratory syncytial virus (RSV) infections were readmitted to the hospital within 28 days, based on new data from more than 67,000 cases.

RSV remains a top cause of acute respiratory tract infections among adults in the United States, with an estimated 159,000 hospitalizations in those aged 65 years or older, wrote Suzanne N. Landi, MPH, PhD, of Pfizer in New York City, and colleagues in a study published in JAMA Network Open.

“Currently, limited estimates exist to determine the risk of hospitalization following outpatient RSV disease diagnoses in the United States,” said corresponding author Joshua T. Swan, PharmD, MPH, in an interview.

The current study was conducted to inform development of clinical trials, said Swan, senior director and category clinician in internal medicine and disease development at Pfizer, the sponsor of the study. These trials would assess the efficacy of an outpatient RSV antiviral treatment in preventing RSV-related hospitalization within 28 days among adults at a high risk for progression to severe illness, he said.

The authors reviewed data from 67,239 adults aged 18 years or older with medically attended RSV infections between October 1, 2016, and September 30, 2022. The data came from three databases: Optum (2771 patients), TriNetX (7442 patients), and Veradigm Network Electronic Health Record (VNEHR; 57,026 patients).

The primary outcome was all-cause hospitalization within 28 days of medically attended RSV.

Overall, the proportions of patients hospitalized within 28 days of infection were 6.2%, 6.0%, and 4.5% in Optum, TriNetX, and VNEHR databases, respectively.

Approximately two thirds of the patients (62%-67% across the three databases) were women, and 14.0%-54.5% were aged 65 years or older. The researchers also identified comorbidity prevalences of 20.0%-30.5% for chronic obstructive pulmonary disease (COPD), 14.6%-24.4% for heart failure (HF), and 14.6%-24.4% for asthma.

A majority of the patients (ranging from 74.5% to 90.6% across the three databases) fell into a high-risk subgroup, defined as age 65 years or older with asthma, COPD, and HF. In this high-risk group, the proportions of hospitalizations were 7.6%, 8.5%, and 6.5% for Optum, TriNetX, and VNEHR, respectively.

The findings were limited by several factors, including the use only of data from outpatient settings, which cannot be used to estimate the RSV burden in the general population, and the reliance only on diagnosis or procedure codes to identify comorbidities, the researchers noted.

However, “the absolute risk of hospitalization of 1 out of 20 patients observed in our study represents significant and meaningful risk for vulnerable adults, in a disease where much of the public’s attention has historically focused on risk of hospitalization for young children,” Swan said. “These results highlight the unmet medical need for outpatient interventions and preventive measures that can reduce hospitalizations.” 

 

Don’t Underestimate RSV Impact

The current study highlights the fact that RSV is a major cause of respiratory viral illness, said David R. Manoff, MD, associate professor of clinical thoracic medicine and surgery at Temple University, Philadelphia, in an interview.

“Historically, influenza, and, more recently, COVID-19 infection have generally been thought of as more likely to cause harm and, thus, have been more emphasized in terms of both vaccination and treatment,” said Manoff, who was not involved in the study.

The current study provides new evidence that infection with RSV can be far more serious than often recognized and a major potential source of both hospitalization and morbidity, Manoff said. In fact, data published in Morbidity and Mortality Weekly Report in 2023 showed that the risks of needing oxygen, intensive care unit (ICU) admission, intubation, and death were actually higher in patients hospitalized with RSV infections than in those hospitalized with influenza or COVID-19. “

Understanding which population is hospitalized in the first place is vital to targeting prevention measures,” he added.

The new data are consistent with previous studies showing that most patients with RSV infection have primarily upper respiratory tract infection–type symptoms, but that a minority will develop lower respiratory tract disease, Manoff noted.

The findings add to the argument for implementation of RSV vaccination, especially in high-risk individuals, and support the need for RSV testing when patients present for care, he said.

However, more research is needed to reflect recent numbers, Manoff said. The study timeframe of 2016-2022 not only precedes commercially available RSV vaccines but also includes the period of increased isolation and masking seen during the COVID-19 pandemic years of 2020-2021. “We need to see if the same trends continue in the post-pandemic era.” 

Additionally, the studies leading to approval of the RSV vaccine showed a reduction in hospitalization with RSV, and it is important to see how this reduction translates in real-world data and whether the RSV vaccines are reducing need for ICU admission, intubation, and death, Manoff said.

The study was funded by Pfizer, and Swan is a Pfizer employee. Manoff had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Approximately 1 in 20 adults with outpatient respiratory syncytial virus (RSV) infections were readmitted to the hospital within 28 days, based on new data from more than 67,000 cases.

RSV remains a top cause of acute respiratory tract infections among adults in the United States, with an estimated 159,000 hospitalizations in those aged 65 years or older, wrote Suzanne N. Landi, MPH, PhD, of Pfizer in New York City, and colleagues in a study published in JAMA Network Open.

“Currently, limited estimates exist to determine the risk of hospitalization following outpatient RSV disease diagnoses in the United States,” said corresponding author Joshua T. Swan, PharmD, MPH, in an interview.

The current study was conducted to inform development of clinical trials, said Swan, senior director and category clinician in internal medicine and disease development at Pfizer, the sponsor of the study. These trials would assess the efficacy of an outpatient RSV antiviral treatment in preventing RSV-related hospitalization within 28 days among adults at a high risk for progression to severe illness, he said.

The authors reviewed data from 67,239 adults aged 18 years or older with medically attended RSV infections between October 1, 2016, and September 30, 2022. The data came from three databases: Optum (2771 patients), TriNetX (7442 patients), and Veradigm Network Electronic Health Record (VNEHR; 57,026 patients).

The primary outcome was all-cause hospitalization within 28 days of medically attended RSV.

Overall, the proportions of patients hospitalized within 28 days of infection were 6.2%, 6.0%, and 4.5% in Optum, TriNetX, and VNEHR databases, respectively.

Approximately two thirds of the patients (62%-67% across the three databases) were women, and 14.0%-54.5% were aged 65 years or older. The researchers also identified comorbidity prevalences of 20.0%-30.5% for chronic obstructive pulmonary disease (COPD), 14.6%-24.4% for heart failure (HF), and 14.6%-24.4% for asthma.

A majority of the patients (ranging from 74.5% to 90.6% across the three databases) fell into a high-risk subgroup, defined as age 65 years or older with asthma, COPD, and HF. In this high-risk group, the proportions of hospitalizations were 7.6%, 8.5%, and 6.5% for Optum, TriNetX, and VNEHR, respectively.

The findings were limited by several factors, including the use only of data from outpatient settings, which cannot be used to estimate the RSV burden in the general population, and the reliance only on diagnosis or procedure codes to identify comorbidities, the researchers noted.

However, “the absolute risk of hospitalization of 1 out of 20 patients observed in our study represents significant and meaningful risk for vulnerable adults, in a disease where much of the public’s attention has historically focused on risk of hospitalization for young children,” Swan said. “These results highlight the unmet medical need for outpatient interventions and preventive measures that can reduce hospitalizations.” 

 

Don’t Underestimate RSV Impact

The current study highlights the fact that RSV is a major cause of respiratory viral illness, said David R. Manoff, MD, associate professor of clinical thoracic medicine and surgery at Temple University, Philadelphia, in an interview.

“Historically, influenza, and, more recently, COVID-19 infection have generally been thought of as more likely to cause harm and, thus, have been more emphasized in terms of both vaccination and treatment,” said Manoff, who was not involved in the study.

The current study provides new evidence that infection with RSV can be far more serious than often recognized and a major potential source of both hospitalization and morbidity, Manoff said. In fact, data published in Morbidity and Mortality Weekly Report in 2023 showed that the risks of needing oxygen, intensive care unit (ICU) admission, intubation, and death were actually higher in patients hospitalized with RSV infections than in those hospitalized with influenza or COVID-19. “

Understanding which population is hospitalized in the first place is vital to targeting prevention measures,” he added.

The new data are consistent with previous studies showing that most patients with RSV infection have primarily upper respiratory tract infection–type symptoms, but that a minority will develop lower respiratory tract disease, Manoff noted.

The findings add to the argument for implementation of RSV vaccination, especially in high-risk individuals, and support the need for RSV testing when patients present for care, he said.

However, more research is needed to reflect recent numbers, Manoff said. The study timeframe of 2016-2022 not only precedes commercially available RSV vaccines but also includes the period of increased isolation and masking seen during the COVID-19 pandemic years of 2020-2021. “We need to see if the same trends continue in the post-pandemic era.” 

Additionally, the studies leading to approval of the RSV vaccine showed a reduction in hospitalization with RSV, and it is important to see how this reduction translates in real-world data and whether the RSV vaccines are reducing need for ICU admission, intubation, and death, Manoff said.

The study was funded by Pfizer, and Swan is a Pfizer employee. Manoff had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

A report published in July 2024 by the US Senate Special Committee on Aging is calling for a national coordinated response to what the authors claim may be an emerging hoarding disorder (HD) crisis.

While millions of US adults are estimated to have HD, it is the disorder’s prevalence and severity among older adults that sounded the alarm for the Committee Chair Sen. Bob Casey (D-PA).

HD affects roughly 2% of the overall population but up to 6% of all people older than 70 years, the report stated. Older adults made up about 16% of the US population in 2019. By 2060, that proportion is projected to soar to 25%.

The country’s aging population alone “could fuel a rise in hoarding in the coming decades,” the report authors noted.

These findings underscore the pressing need for a deeper understanding of HD, particularly as reports of its impact continue to rise. The Senate report also raises critical questions about the nature of HD: What is known about the condition? What evidence-based treatments are currently available, and are there national strategies that will prevent it from becoming a systemic crisis?

 

Why the Urgency?

An increase in anecdotal reports of HD in his home state prompted Casey, chair of the Senate Committee on Aging, to launch the investigation into the incidence and consequences of HD. Soon after the committee began its work, it became evident that the problem was not unique to communities in Pennsylvania. It was a nationwide issue.

“Communities throughout the United States are already grappling with HD,” the report noted.

HD is characterized by persistent difficulty discarding possessions, regardless of their monetary value. For individuals with HD, such items frequently hold meaningful reminders of past events and provide a sense of security. Difficulties with emotional regulation, executive functioning, and impulse control all contribute to the excessive buildup of clutter. Problems with attention, organization, and problem-solving are also common.

As individuals with HD age, physical limitations or disabilities may hinder their ability to discard clutter. As the accumulation increases, it can pose serious risks not only to their safety but also to public health.

Dozens of statements submitted to the Senate committee by those with HD, clinicians and social workers, first responders, social service organizations, state and federal agencies, and professional societies paint a concerning picture about the impact of hoarding on emergency and community services.

Data from the National Fire Incident Reporting System show the number of hoarding-related residential structural fires increased 26% between 2014 and 2022. Some 5242 residential fires connected to cluttered environments during that time resulted in 1367 fire service injuries, 1119 civilian injuries, and over $396 million in damages.

“For older adults, those consequences include health and safety risks, social isolation, eviction, and homelessness,” the report authors noted. “For communities, those consequences include public health concerns, increased risk of fire, and dangers to emergency responders.”

 

What Causes HD?

HD was once classified as a symptom of obsessive-compulsive personality disorder, with extreme causes meeting the diagnostic criteria for obsessive-compulsive disorder. That changed in 2010 when a working group recommended that HD be added to the Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition, as a stand-alone disorder. That recommendation was approved in 2012.

However, a decade later, much about HD’s etiology remains unknown.

Often beginning in early adolescence, HD is a chronic and progressive condition, with genetics and trauma playing a role in its onset and course, Sanjaya Saxena, MD, director of Clinical and Research Affairs at the International OCD Foundation, said in an interview.

Between 50% and 85% of people with HD symptoms have family members with similar behavior. HD is often comorbid with other psychiatric and medical disorders, which can complicate treatment.

Results of a 2022 study showed that, compared with healthy control individuals, people with HD had widespread abnormalities in the prefrontal white matter tract which connects cortical regions involved in executive functioning, including working memory, attention, reward processing, and decision-making.

Some research also suggests that dysregulation of serotonin transmission may contribute to compulsive behaviors and the difficulty in letting go of possessions.

“We do know that there are factors that contribute to worsening of hoarding symptoms, but that’s not the same thing as what really causes it. So unfortunately, it’s still very understudied, and we don’t have great knowledge of what causes it,” Saxena said.

 

What Treatments Are Available?

There are currently no Food and Drug Administration–approved medications to treat HD, although some research has shown antidepressants paroxetine and venlafaxine may have some benefit. Methylphenidate and atomoxetine are also under study for HD.

Nonpharmacological therapies have shown more promising results. Among the first was a specialized cognitive-behavioral therapy (CBT) program developed by Randy Frost, PhD, professor emeritus of psychology at Smith College in Northampton, Massachusetts, and Gail Steketee, PhD, dean emerita and professor emerita of social work at Boston University in Massachusetts.

First published in 2007 and the subject of many clinical trials and studies since, the 26-session program has served as a model for psychosocial treatments for HD. The evidence-based therapy addresses various symptoms, including impulse control. One module encourages participants to develop a set of questions to consider before acquiring new items, gradually helping them build resistance to the urge to accumulate more possessions, said Frost, whose early work on HD was cited by those who supported adding the condition to the DSM in 2012.

“There are several features that I think are important including exercises in resisting acquiring and processing information when making decisions about discarding,” Frost said in an interview.

A number of studies have demonstrated the efficacy of CBT for HD, including a 2015 meta-analysis coauthored by Frost. The research showed symptom severity decreased significantly following CBT, with the largest gains in difficulty discarding and moderate improvements in clutter and acquiring.

Responses were better among women and younger patients, and although symptoms improved, posttreatment scores remained closer to the clinical range, researchers noted. It’s possible that more intervention beyond what is usually included in clinical trials — such as more sessions or adding home decluttering visits — could improve treatment response, they added.

A workshop based on the specialized CBT program has expanded the reach of the treatment. The group therapy project, Buried in Treasures (BiT), was developed by Frost, Steketee, and David Tolin, PhD, founder and director of the Anxiety Disorders Center at the Institute of Living, Hartford, and an adjunct professor of psychiatry at Yale School of Medicine, New Haven, Connecticut. The workshop is designed as a facilitated treatment that can be delivered by clinicians or trained nonclinician facilitators.

A study published in May found that more than half the participants with HD responded to the treatment, and of those, 39% reported significant reductions in HD symptoms. BiT sessions were led by trained facilitators, and the study included in-home decluttering sessions, also led by trained volunteers. Researchers said adding the home intervention could increase engagement with the group therapy.

Another study of a modified version of BiT found a 32% decrease in HD symptoms after 15 weeks of treatment delivered via video teleconference.

“The BiT workshop has been expanding around the world and has the advantage of being relatively inexpensive,” Frost said. Another advantage is that it can be run by nonclinicians, which expands treatment options in areas where mental health professionals trained to treat HD are in short supply.

However, the workshop “is not perfect, and clients usually still have symptoms at the end of the workshop,” Frost noted.

“The point is that the BiT workshop is the first step in changing a lifestyle related to possessions,” he continued. “We do certainly need to train more people in how to treat hoarding, and we need to facilitate research to make our treatments more effective.”

 

What’s New in the Field?

One novel program currently under study combines CBT with a cognitive rehabilitation protocol. Called Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST), the program has been shown to help older adults with HD who don’t respond to traditional CBT for HD.

The program, led by Catherine Ayers, PhD, professor of clinical psychiatry at University of California, San Diego, involves memory training and problem-solving combined with exposure therapy to help participants learn how to tolerate distress associated with discarding their possessions.

Early findings pointed to symptom improvement in older adults following 24 sessions with CREST. The program fared better than geriatric case management in a 2018 study — the first randomized controlled trial of a treatment for HD in older adults — and offered additional benefits compared with exposure therapy in a study published in February 2024.

Virtual reality is also helping people with HD. A program developed at Stanford University in California, allows people with HD to work with a therapist as they practice decluttering in a three-dimensional virtual environment created using photographs and videos of actual hoarded objects and cluttered rooms in patients’ homes.

In a small pilot study, nine people older than 55 years with HD attended 16 weeks of online facilitated therapy where they learned to better understand their attachment to those items. They practiced decluttering by selecting virtual items for recycling, donation, or trash. A virtual garbage truck even hauled away the items they had placed in the trash.

Participants were then asked to discard the actual items at home. Most participants reported a decrease in hoarding symptoms, which was confirmed following a home assessment by a clinician.

“When you pick up an object from a loved one, it still maybe has the scent of the loved one. It has these tactile cues, colors. But in the virtual world, you can take a little bit of a step back,” lead researchers Carolyn Rodriguez, MD, PhD, director of Stanford’s Hoarding Disorders Research Program, said in an interview.

“It’s a little ramp to help people practice these skills. And then what we find is that it actually translated really well. They were able to go home and actually do the real uncluttering,” Rodriguez added.

 

What Else Can Be Done?

While researchers like Rodriguez continue studies of new and existing treatments, the Senate report draws attention to other responses that could aid people with HD. Because of its significant impact on emergency responders, adult protective services, aging services, and housing providers, the report recommends a nationwide response to older adults with HD.

Currently, federal agencies in charge of mental and community health are not doing enough to address HD, the report’s authors noted.

The report demonstrates “the scope and severity of these challenges and offers a path forward for how we can help people, communities, and local governments contend with this condition,” Casey said.

Specifically, the document cites a lack of HD services and tracking by the Substance Abuse and Mental Health Services Administration, the Administration for Community Living, and the Centers for Disease Control and Prevention.

The committee recommended these agencies collaborate to improve HD data collection, which will be critical to managing a potential spike in cases as the population ages. The committee also suggested awareness and training campaigns to better educate clinicians, social service providers, court officials, and first responders about HD.

Further, the report’s authors called for the Department of Housing and Urban Development to provide guidance and technical assistance on HD for landlords and housing assistance programs and urged Congress to collaborate with the Centers for Medicare & Medicaid Services to expand coverage for hoarding treatments.

Finally, the committee encouraged policymakers to engage directly with individuals affected by HD and their families to better understand the impact of the disorder and inform policy development.

“I think the Senate report focuses on education, not just for therapists, but other stakeholders too,” Frost said. “There are lots of other professionals who have a stake in this process, housing specialists, elder service folks, health and human services. Awareness of this problem is something that’s important for them as well.”

Rodriguez characterized the report’s recommendations as “potentially lifesaving” for individuals with HD. She added that it represents the first step in an ongoing effort to address an impending public health crisis related to HD in older adults and its broader impact on communities.

A spokesperson with Casey’s office said it’s unclear whether any federal agencies have acted on the report recommendations since it was released in June. It’s also unknown whether the Senate Committee on Aging will pursue any additional work on HD when new committee leaders are appointed in 2025.

“Although some federal agencies have taken steps to address HD, those steps are frequently limited. Other relevant agencies have not addressed HD at all in recent years,” report authors wrote. “The federal government can, and should, do more to bolster the response to HD.”

Frost agreed.

“I think federal agencies can have a positive effect by promoting, supporting, and tracking local efforts in dealing with this problem,” he said.

With reporting from Eve Bender.

A version of this article appeared on Medscape.com.

A report published in July 2024 by the US Senate Special Committee on Aging is calling for a national coordinated response to what the authors claim may be an emerging hoarding disorder (HD) crisis.

While millions of US adults are estimated to have HD, it is the disorder’s prevalence and severity among older adults that sounded the alarm for the Committee Chair Sen. Bob Casey (D-PA).

HD affects roughly 2% of the overall population but up to 6% of all people older than 70 years, the report stated. Older adults made up about 16% of the US population in 2019. By 2060, that proportion is projected to soar to 25%.

The country’s aging population alone “could fuel a rise in hoarding in the coming decades,” the report authors noted.

These findings underscore the pressing need for a deeper understanding of HD, particularly as reports of its impact continue to rise. The Senate report also raises critical questions about the nature of HD: What is known about the condition? What evidence-based treatments are currently available, and are there national strategies that will prevent it from becoming a systemic crisis?

 

Why the Urgency?

An increase in anecdotal reports of HD in his home state prompted Casey, chair of the Senate Committee on Aging, to launch the investigation into the incidence and consequences of HD. Soon after the committee began its work, it became evident that the problem was not unique to communities in Pennsylvania. It was a nationwide issue.

“Communities throughout the United States are already grappling with HD,” the report noted.

HD is characterized by persistent difficulty discarding possessions, regardless of their monetary value. For individuals with HD, such items frequently hold meaningful reminders of past events and provide a sense of security. Difficulties with emotional regulation, executive functioning, and impulse control all contribute to the excessive buildup of clutter. Problems with attention, organization, and problem-solving are also common.

As individuals with HD age, physical limitations or disabilities may hinder their ability to discard clutter. As the accumulation increases, it can pose serious risks not only to their safety but also to public health.

Dozens of statements submitted to the Senate committee by those with HD, clinicians and social workers, first responders, social service organizations, state and federal agencies, and professional societies paint a concerning picture about the impact of hoarding on emergency and community services.

Data from the National Fire Incident Reporting System show the number of hoarding-related residential structural fires increased 26% between 2014 and 2022. Some 5242 residential fires connected to cluttered environments during that time resulted in 1367 fire service injuries, 1119 civilian injuries, and over $396 million in damages.

“For older adults, those consequences include health and safety risks, social isolation, eviction, and homelessness,” the report authors noted. “For communities, those consequences include public health concerns, increased risk of fire, and dangers to emergency responders.”

 

What Causes HD?

HD was once classified as a symptom of obsessive-compulsive personality disorder, with extreme causes meeting the diagnostic criteria for obsessive-compulsive disorder. That changed in 2010 when a working group recommended that HD be added to the Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition, as a stand-alone disorder. That recommendation was approved in 2012.

However, a decade later, much about HD’s etiology remains unknown.

Often beginning in early adolescence, HD is a chronic and progressive condition, with genetics and trauma playing a role in its onset and course, Sanjaya Saxena, MD, director of Clinical and Research Affairs at the International OCD Foundation, said in an interview.

Between 50% and 85% of people with HD symptoms have family members with similar behavior. HD is often comorbid with other psychiatric and medical disorders, which can complicate treatment.

Results of a 2022 study showed that, compared with healthy control individuals, people with HD had widespread abnormalities in the prefrontal white matter tract which connects cortical regions involved in executive functioning, including working memory, attention, reward processing, and decision-making.

Some research also suggests that dysregulation of serotonin transmission may contribute to compulsive behaviors and the difficulty in letting go of possessions.

“We do know that there are factors that contribute to worsening of hoarding symptoms, but that’s not the same thing as what really causes it. So unfortunately, it’s still very understudied, and we don’t have great knowledge of what causes it,” Saxena said.

 

What Treatments Are Available?

There are currently no Food and Drug Administration–approved medications to treat HD, although some research has shown antidepressants paroxetine and venlafaxine may have some benefit. Methylphenidate and atomoxetine are also under study for HD.

Nonpharmacological therapies have shown more promising results. Among the first was a specialized cognitive-behavioral therapy (CBT) program developed by Randy Frost, PhD, professor emeritus of psychology at Smith College in Northampton, Massachusetts, and Gail Steketee, PhD, dean emerita and professor emerita of social work at Boston University in Massachusetts.

First published in 2007 and the subject of many clinical trials and studies since, the 26-session program has served as a model for psychosocial treatments for HD. The evidence-based therapy addresses various symptoms, including impulse control. One module encourages participants to develop a set of questions to consider before acquiring new items, gradually helping them build resistance to the urge to accumulate more possessions, said Frost, whose early work on HD was cited by those who supported adding the condition to the DSM in 2012.

“There are several features that I think are important including exercises in resisting acquiring and processing information when making decisions about discarding,” Frost said in an interview.

A number of studies have demonstrated the efficacy of CBT for HD, including a 2015 meta-analysis coauthored by Frost. The research showed symptom severity decreased significantly following CBT, with the largest gains in difficulty discarding and moderate improvements in clutter and acquiring.

Responses were better among women and younger patients, and although symptoms improved, posttreatment scores remained closer to the clinical range, researchers noted. It’s possible that more intervention beyond what is usually included in clinical trials — such as more sessions or adding home decluttering visits — could improve treatment response, they added.

A workshop based on the specialized CBT program has expanded the reach of the treatment. The group therapy project, Buried in Treasures (BiT), was developed by Frost, Steketee, and David Tolin, PhD, founder and director of the Anxiety Disorders Center at the Institute of Living, Hartford, and an adjunct professor of psychiatry at Yale School of Medicine, New Haven, Connecticut. The workshop is designed as a facilitated treatment that can be delivered by clinicians or trained nonclinician facilitators.

A study published in May found that more than half the participants with HD responded to the treatment, and of those, 39% reported significant reductions in HD symptoms. BiT sessions were led by trained facilitators, and the study included in-home decluttering sessions, also led by trained volunteers. Researchers said adding the home intervention could increase engagement with the group therapy.

Another study of a modified version of BiT found a 32% decrease in HD symptoms after 15 weeks of treatment delivered via video teleconference.

“The BiT workshop has been expanding around the world and has the advantage of being relatively inexpensive,” Frost said. Another advantage is that it can be run by nonclinicians, which expands treatment options in areas where mental health professionals trained to treat HD are in short supply.

However, the workshop “is not perfect, and clients usually still have symptoms at the end of the workshop,” Frost noted.

“The point is that the BiT workshop is the first step in changing a lifestyle related to possessions,” he continued. “We do certainly need to train more people in how to treat hoarding, and we need to facilitate research to make our treatments more effective.”

 

What’s New in the Field?

One novel program currently under study combines CBT with a cognitive rehabilitation protocol. Called Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST), the program has been shown to help older adults with HD who don’t respond to traditional CBT for HD.

The program, led by Catherine Ayers, PhD, professor of clinical psychiatry at University of California, San Diego, involves memory training and problem-solving combined with exposure therapy to help participants learn how to tolerate distress associated with discarding their possessions.

Early findings pointed to symptom improvement in older adults following 24 sessions with CREST. The program fared better than geriatric case management in a 2018 study — the first randomized controlled trial of a treatment for HD in older adults — and offered additional benefits compared with exposure therapy in a study published in February 2024.

Virtual reality is also helping people with HD. A program developed at Stanford University in California, allows people with HD to work with a therapist as they practice decluttering in a three-dimensional virtual environment created using photographs and videos of actual hoarded objects and cluttered rooms in patients’ homes.

In a small pilot study, nine people older than 55 years with HD attended 16 weeks of online facilitated therapy where they learned to better understand their attachment to those items. They practiced decluttering by selecting virtual items for recycling, donation, or trash. A virtual garbage truck even hauled away the items they had placed in the trash.

Participants were then asked to discard the actual items at home. Most participants reported a decrease in hoarding symptoms, which was confirmed following a home assessment by a clinician.

“When you pick up an object from a loved one, it still maybe has the scent of the loved one. It has these tactile cues, colors. But in the virtual world, you can take a little bit of a step back,” lead researchers Carolyn Rodriguez, MD, PhD, director of Stanford’s Hoarding Disorders Research Program, said in an interview.

“It’s a little ramp to help people practice these skills. And then what we find is that it actually translated really well. They were able to go home and actually do the real uncluttering,” Rodriguez added.

 

What Else Can Be Done?

While researchers like Rodriguez continue studies of new and existing treatments, the Senate report draws attention to other responses that could aid people with HD. Because of its significant impact on emergency responders, adult protective services, aging services, and housing providers, the report recommends a nationwide response to older adults with HD.

Currently, federal agencies in charge of mental and community health are not doing enough to address HD, the report’s authors noted.

The report demonstrates “the scope and severity of these challenges and offers a path forward for how we can help people, communities, and local governments contend with this condition,” Casey said.

Specifically, the document cites a lack of HD services and tracking by the Substance Abuse and Mental Health Services Administration, the Administration for Community Living, and the Centers for Disease Control and Prevention.

The committee recommended these agencies collaborate to improve HD data collection, which will be critical to managing a potential spike in cases as the population ages. The committee also suggested awareness and training campaigns to better educate clinicians, social service providers, court officials, and first responders about HD.

Further, the report’s authors called for the Department of Housing and Urban Development to provide guidance and technical assistance on HD for landlords and housing assistance programs and urged Congress to collaborate with the Centers for Medicare & Medicaid Services to expand coverage for hoarding treatments.

Finally, the committee encouraged policymakers to engage directly with individuals affected by HD and their families to better understand the impact of the disorder and inform policy development.

“I think the Senate report focuses on education, not just for therapists, but other stakeholders too,” Frost said. “There are lots of other professionals who have a stake in this process, housing specialists, elder service folks, health and human services. Awareness of this problem is something that’s important for them as well.”

Rodriguez characterized the report’s recommendations as “potentially lifesaving” for individuals with HD. She added that it represents the first step in an ongoing effort to address an impending public health crisis related to HD in older adults and its broader impact on communities.

A spokesperson with Casey’s office said it’s unclear whether any federal agencies have acted on the report recommendations since it was released in June. It’s also unknown whether the Senate Committee on Aging will pursue any additional work on HD when new committee leaders are appointed in 2025.

“Although some federal agencies have taken steps to address HD, those steps are frequently limited. Other relevant agencies have not addressed HD at all in recent years,” report authors wrote. “The federal government can, and should, do more to bolster the response to HD.”

Frost agreed.

“I think federal agencies can have a positive effect by promoting, supporting, and tracking local efforts in dealing with this problem,” he said.

With reporting from Eve Bender.

A version of this article appeared on Medscape.com.

A report published in July 2024 by the US Senate Special Committee on Aging is calling for a national coordinated response to what the authors claim may be an emerging hoarding disorder (HD) crisis.

While millions of US adults are estimated to have HD, it is the disorder’s prevalence and severity among older adults that sounded the alarm for the Committee Chair Sen. Bob Casey (D-PA).

HD affects roughly 2% of the overall population but up to 6% of all people older than 70 years, the report stated. Older adults made up about 16% of the US population in 2019. By 2060, that proportion is projected to soar to 25%.

The country’s aging population alone “could fuel a rise in hoarding in the coming decades,” the report authors noted.

These findings underscore the pressing need for a deeper understanding of HD, particularly as reports of its impact continue to rise. The Senate report also raises critical questions about the nature of HD: What is known about the condition? What evidence-based treatments are currently available, and are there national strategies that will prevent it from becoming a systemic crisis?

 

Why the Urgency?

An increase in anecdotal reports of HD in his home state prompted Casey, chair of the Senate Committee on Aging, to launch the investigation into the incidence and consequences of HD. Soon after the committee began its work, it became evident that the problem was not unique to communities in Pennsylvania. It was a nationwide issue.

“Communities throughout the United States are already grappling with HD,” the report noted.

HD is characterized by persistent difficulty discarding possessions, regardless of their monetary value. For individuals with HD, such items frequently hold meaningful reminders of past events and provide a sense of security. Difficulties with emotional regulation, executive functioning, and impulse control all contribute to the excessive buildup of clutter. Problems with attention, organization, and problem-solving are also common.

As individuals with HD age, physical limitations or disabilities may hinder their ability to discard clutter. As the accumulation increases, it can pose serious risks not only to their safety but also to public health.

Dozens of statements submitted to the Senate committee by those with HD, clinicians and social workers, first responders, social service organizations, state and federal agencies, and professional societies paint a concerning picture about the impact of hoarding on emergency and community services.

Data from the National Fire Incident Reporting System show the number of hoarding-related residential structural fires increased 26% between 2014 and 2022. Some 5242 residential fires connected to cluttered environments during that time resulted in 1367 fire service injuries, 1119 civilian injuries, and over $396 million in damages.

“For older adults, those consequences include health and safety risks, social isolation, eviction, and homelessness,” the report authors noted. “For communities, those consequences include public health concerns, increased risk of fire, and dangers to emergency responders.”

 

What Causes HD?

HD was once classified as a symptom of obsessive-compulsive personality disorder, with extreme causes meeting the diagnostic criteria for obsessive-compulsive disorder. That changed in 2010 when a working group recommended that HD be added to the Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition, as a stand-alone disorder. That recommendation was approved in 2012.

However, a decade later, much about HD’s etiology remains unknown.

Often beginning in early adolescence, HD is a chronic and progressive condition, with genetics and trauma playing a role in its onset and course, Sanjaya Saxena, MD, director of Clinical and Research Affairs at the International OCD Foundation, said in an interview.

Between 50% and 85% of people with HD symptoms have family members with similar behavior. HD is often comorbid with other psychiatric and medical disorders, which can complicate treatment.

Results of a 2022 study showed that, compared with healthy control individuals, people with HD had widespread abnormalities in the prefrontal white matter tract which connects cortical regions involved in executive functioning, including working memory, attention, reward processing, and decision-making.

Some research also suggests that dysregulation of serotonin transmission may contribute to compulsive behaviors and the difficulty in letting go of possessions.

“We do know that there are factors that contribute to worsening of hoarding symptoms, but that’s not the same thing as what really causes it. So unfortunately, it’s still very understudied, and we don’t have great knowledge of what causes it,” Saxena said.

 

What Treatments Are Available?

There are currently no Food and Drug Administration–approved medications to treat HD, although some research has shown antidepressants paroxetine and venlafaxine may have some benefit. Methylphenidate and atomoxetine are also under study for HD.

Nonpharmacological therapies have shown more promising results. Among the first was a specialized cognitive-behavioral therapy (CBT) program developed by Randy Frost, PhD, professor emeritus of psychology at Smith College in Northampton, Massachusetts, and Gail Steketee, PhD, dean emerita and professor emerita of social work at Boston University in Massachusetts.

First published in 2007 and the subject of many clinical trials and studies since, the 26-session program has served as a model for psychosocial treatments for HD. The evidence-based therapy addresses various symptoms, including impulse control. One module encourages participants to develop a set of questions to consider before acquiring new items, gradually helping them build resistance to the urge to accumulate more possessions, said Frost, whose early work on HD was cited by those who supported adding the condition to the DSM in 2012.

“There are several features that I think are important including exercises in resisting acquiring and processing information when making decisions about discarding,” Frost said in an interview.

A number of studies have demonstrated the efficacy of CBT for HD, including a 2015 meta-analysis coauthored by Frost. The research showed symptom severity decreased significantly following CBT, with the largest gains in difficulty discarding and moderate improvements in clutter and acquiring.

Responses were better among women and younger patients, and although symptoms improved, posttreatment scores remained closer to the clinical range, researchers noted. It’s possible that more intervention beyond what is usually included in clinical trials — such as more sessions or adding home decluttering visits — could improve treatment response, they added.

A workshop based on the specialized CBT program has expanded the reach of the treatment. The group therapy project, Buried in Treasures (BiT), was developed by Frost, Steketee, and David Tolin, PhD, founder and director of the Anxiety Disorders Center at the Institute of Living, Hartford, and an adjunct professor of psychiatry at Yale School of Medicine, New Haven, Connecticut. The workshop is designed as a facilitated treatment that can be delivered by clinicians or trained nonclinician facilitators.

A study published in May found that more than half the participants with HD responded to the treatment, and of those, 39% reported significant reductions in HD symptoms. BiT sessions were led by trained facilitators, and the study included in-home decluttering sessions, also led by trained volunteers. Researchers said adding the home intervention could increase engagement with the group therapy.

Another study of a modified version of BiT found a 32% decrease in HD symptoms after 15 weeks of treatment delivered via video teleconference.

“The BiT workshop has been expanding around the world and has the advantage of being relatively inexpensive,” Frost said. Another advantage is that it can be run by nonclinicians, which expands treatment options in areas where mental health professionals trained to treat HD are in short supply.

However, the workshop “is not perfect, and clients usually still have symptoms at the end of the workshop,” Frost noted.

“The point is that the BiT workshop is the first step in changing a lifestyle related to possessions,” he continued. “We do certainly need to train more people in how to treat hoarding, and we need to facilitate research to make our treatments more effective.”

 

What’s New in the Field?

One novel program currently under study combines CBT with a cognitive rehabilitation protocol. Called Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST), the program has been shown to help older adults with HD who don’t respond to traditional CBT for HD.

The program, led by Catherine Ayers, PhD, professor of clinical psychiatry at University of California, San Diego, involves memory training and problem-solving combined with exposure therapy to help participants learn how to tolerate distress associated with discarding their possessions.

Early findings pointed to symptom improvement in older adults following 24 sessions with CREST. The program fared better than geriatric case management in a 2018 study — the first randomized controlled trial of a treatment for HD in older adults — and offered additional benefits compared with exposure therapy in a study published in February 2024.

Virtual reality is also helping people with HD. A program developed at Stanford University in California, allows people with HD to work with a therapist as they practice decluttering in a three-dimensional virtual environment created using photographs and videos of actual hoarded objects and cluttered rooms in patients’ homes.

In a small pilot study, nine people older than 55 years with HD attended 16 weeks of online facilitated therapy where they learned to better understand their attachment to those items. They practiced decluttering by selecting virtual items for recycling, donation, or trash. A virtual garbage truck even hauled away the items they had placed in the trash.

Participants were then asked to discard the actual items at home. Most participants reported a decrease in hoarding symptoms, which was confirmed following a home assessment by a clinician.

“When you pick up an object from a loved one, it still maybe has the scent of the loved one. It has these tactile cues, colors. But in the virtual world, you can take a little bit of a step back,” lead researchers Carolyn Rodriguez, MD, PhD, director of Stanford’s Hoarding Disorders Research Program, said in an interview.

“It’s a little ramp to help people practice these skills. And then what we find is that it actually translated really well. They were able to go home and actually do the real uncluttering,” Rodriguez added.

 

What Else Can Be Done?

While researchers like Rodriguez continue studies of new and existing treatments, the Senate report draws attention to other responses that could aid people with HD. Because of its significant impact on emergency responders, adult protective services, aging services, and housing providers, the report recommends a nationwide response to older adults with HD.

Currently, federal agencies in charge of mental and community health are not doing enough to address HD, the report’s authors noted.

The report demonstrates “the scope and severity of these challenges and offers a path forward for how we can help people, communities, and local governments contend with this condition,” Casey said.

Specifically, the document cites a lack of HD services and tracking by the Substance Abuse and Mental Health Services Administration, the Administration for Community Living, and the Centers for Disease Control and Prevention.

The committee recommended these agencies collaborate to improve HD data collection, which will be critical to managing a potential spike in cases as the population ages. The committee also suggested awareness and training campaigns to better educate clinicians, social service providers, court officials, and first responders about HD.

Further, the report’s authors called for the Department of Housing and Urban Development to provide guidance and technical assistance on HD for landlords and housing assistance programs and urged Congress to collaborate with the Centers for Medicare & Medicaid Services to expand coverage for hoarding treatments.

Finally, the committee encouraged policymakers to engage directly with individuals affected by HD and their families to better understand the impact of the disorder and inform policy development.

“I think the Senate report focuses on education, not just for therapists, but other stakeholders too,” Frost said. “There are lots of other professionals who have a stake in this process, housing specialists, elder service folks, health and human services. Awareness of this problem is something that’s important for them as well.”

Rodriguez characterized the report’s recommendations as “potentially lifesaving” for individuals with HD. She added that it represents the first step in an ongoing effort to address an impending public health crisis related to HD in older adults and its broader impact on communities.

A spokesperson with Casey’s office said it’s unclear whether any federal agencies have acted on the report recommendations since it was released in June. It’s also unknown whether the Senate Committee on Aging will pursue any additional work on HD when new committee leaders are appointed in 2025.

“Although some federal agencies have taken steps to address HD, those steps are frequently limited. Other relevant agencies have not addressed HD at all in recent years,” report authors wrote. “The federal government can, and should, do more to bolster the response to HD.”

Frost agreed.

“I think federal agencies can have a positive effect by promoting, supporting, and tracking local efforts in dealing with this problem,” he said.

With reporting from Eve Bender.

A version of this article appeared on Medscape.com.

Despite 4 years of med school and 3-7 years in residency, when you enter the workforce as a doctor, you still have much to learn. There is only so much your professors and attending physicians can pack in. Going forward, you’ll continue to learn on the job and via continuing education.

Some of that lifelong learning will involve soft skills — how to compassionately work with your patients and their families, for instance. Other lessons will get down to the business of medicine — the paperwork, the work/life balance, and the moral dilemmas you never saw coming. And still others will involve learning how to take care of yourself in the middle of seemingly endless hours on the job.

“We all have things we wish we had known upon starting our careers,” said Daniel Opris, MD, a primary care physician at Ohio-based Executive Medical Centers.

We tapped several veteran physicians and an educator to learn what they wish med students knew as they enter the workforce. We’ve compiled them here to give you a head start on the lessons ahead. 

 

You Won’t Know Everything, and That’s Okay

When you go through your medical training, it can feel overwhelming to absorb all the knowledge your professors and attendings impart. The bottom line, said Shoshana Ungerleider, MD, an internal medicine specialist, is that you shouldn’t worry about it.

“No one expects you to know it all,” she explained. “What’s important is to cultivate curiosity and a willingness to ask for help when needed.” 

David Lenihan, PhD, CEO at Ponce Health Sciences University, agrees. “What we’ve lost in recent years, is the ability to apply your skill set and say, ‘let me take a day and get back to you,’” he said. “Doctors love it when you do that because it shows you can pitch in and work as part of a team.”

Medicine is a collaborative field, said Ungerleider, and learning from others, whether peers, nurses, or specialists, is “not a weakness.” She recommends embracing uncertainty and getting comfortable with the unknown.

 

You’ll Take Your Work Home With You

Doctors enter the field because they care about their patients and want to help. Successful outcomes are never guaranteed, however, no matter how much you try. The result? Some days you’ll bring home those upsetting and haunting cases, said Lenihan. 

“We often believe that we should leave our work at the office, but sometimes you need to bring it home and think it through,” he said. “It can’t overwhelm you, but you should digest what happened.”

When you do, said Lenihan, you’ll come out the other end more empathetic and that helps the healthcare system in the long run. “The more you reflect on your day, the better you’ll get at reading the room and treating your patients.”

Drew Remignanti, MD, a retired emergency medicine physician from New Hampshire, agrees, but puts a different spin on bringing work home. 

“We revisit the patient care decisions we made, second-guess ourselves, and worry about our patients’ welfare and outcomes,” he said. “I think it can only lead to better outcomes down the road, however, if you learn from that bad decision, preventing you from committing a similar mistake.”

 

Burnout Is Real — Make Self-Care a Priority 

As a retired physician who spent 40 years practicing medicine, Remignanti experienced the evolution of healthcare as it has become what he calls a “consumer-provider” model. “Productivity didn’t use to be part of the equation, but now it’s the focus,” he said. 

The result is burnout, a very real threat to incoming physicians. Remignanti holds that if you are aware of the risk, you can resist it. Part of avoiding burnout is self-care, according to Ungerleider. “The sooner you prioritize your mental, emotional, and physical well-being, the better,” she said. “Balancing work and life may feel impossible at times but taking care of yourself is essential to being a better physician in the long run.”

That means carving out time for exercise, hobbies, and connections outside of the medical field. It also means making sleep and nutrition a priority, even when that feels hard to accomplish. “If you don’t take care of yourself, you can’t take care of others,” added Opris. “It’s so common to lose yourself in your career, but you need to hold onto your physical, emotional, and spiritual self.”

 

Avoid Relying Too Heavily on Tech

Technology is invading every aspect of our lives — often for the greater good — but in medicine, it’s important to always return to your core knowledge above all else. Case in point, said Opris, the UpToDate app. While it can be a useful tool, it’s important not to become too reliant on it. “UpToDate is expert opinion-based guidance, and it’s a fantastic resource,” he said. “But you need to use your references and knowledge in every case.”

It’s key to remember that every patient is different, and their case may not line up perfectly with the guidance presented in UpToDate or other technology source. Piggybacking on that, Ungerleider added that it’s important to remember medicine is about people, not just conditions.

“It’s easy to focus on mastering the science, but the real art of medicine comes from seeing the whole person in front of you,” she said. “Your patients are more than their diagnoses — they come with complex emotions, life stories, and needs.” Being compassionate, listening carefully, and building trust should match up to your clinical skills.

 

Partner With Your Patients, Even When It’s Difficult

Perhaps the most difficult lesson of all is remembering that your patients may not always agree with your recommendations and choose to ignore them. After all your years spent learning, there may be times when it feels your education is going to waste.

“Remember that the landscape today is so varied, and that bleeds into medicine,” said Opris. “We go into cases with our own biases, and it’s important to take a step back to reset, every time.”

Opris reminds himself of Sir William Osler’s famous essay, “Aequanimitas,” in which he tells graduating medical students to practice with “coolness and presence of mind under all circumstances.”

Remignanti offers this advice: “Physicians need to be able to partner with their patients and jointly decide which courses of action are most effective,” he said. “Cling to the idea that you are forming a partnership with your patients — what can we together determine is the best course?”

At the same time, the path the patient chooses may not be what’s best for them — potentially even leading to a poor outcome.

“You may not always understand their choices,” said Opris. “But they do have a choice. Think of yourself almost like a consultant.”

 

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

Despite 4 years of med school and 3-7 years in residency, when you enter the workforce as a doctor, you still have much to learn. There is only so much your professors and attending physicians can pack in. Going forward, you’ll continue to learn on the job and via continuing education.

Some of that lifelong learning will involve soft skills — how to compassionately work with your patients and their families, for instance. Other lessons will get down to the business of medicine — the paperwork, the work/life balance, and the moral dilemmas you never saw coming. And still others will involve learning how to take care of yourself in the middle of seemingly endless hours on the job.

“We all have things we wish we had known upon starting our careers,” said Daniel Opris, MD, a primary care physician at Ohio-based Executive Medical Centers.

We tapped several veteran physicians and an educator to learn what they wish med students knew as they enter the workforce. We’ve compiled them here to give you a head start on the lessons ahead. 

 

You Won’t Know Everything, and That’s Okay

When you go through your medical training, it can feel overwhelming to absorb all the knowledge your professors and attendings impart. The bottom line, said Shoshana Ungerleider, MD, an internal medicine specialist, is that you shouldn’t worry about it.

“No one expects you to know it all,” she explained. “What’s important is to cultivate curiosity and a willingness to ask for help when needed.” 

David Lenihan, PhD, CEO at Ponce Health Sciences University, agrees. “What we’ve lost in recent years, is the ability to apply your skill set and say, ‘let me take a day and get back to you,’” he said. “Doctors love it when you do that because it shows you can pitch in and work as part of a team.”

Medicine is a collaborative field, said Ungerleider, and learning from others, whether peers, nurses, or specialists, is “not a weakness.” She recommends embracing uncertainty and getting comfortable with the unknown.

 

You’ll Take Your Work Home With You

Doctors enter the field because they care about their patients and want to help. Successful outcomes are never guaranteed, however, no matter how much you try. The result? Some days you’ll bring home those upsetting and haunting cases, said Lenihan. 

“We often believe that we should leave our work at the office, but sometimes you need to bring it home and think it through,” he said. “It can’t overwhelm you, but you should digest what happened.”

When you do, said Lenihan, you’ll come out the other end more empathetic and that helps the healthcare system in the long run. “The more you reflect on your day, the better you’ll get at reading the room and treating your patients.”

Drew Remignanti, MD, a retired emergency medicine physician from New Hampshire, agrees, but puts a different spin on bringing work home. 

“We revisit the patient care decisions we made, second-guess ourselves, and worry about our patients’ welfare and outcomes,” he said. “I think it can only lead to better outcomes down the road, however, if you learn from that bad decision, preventing you from committing a similar mistake.”

 

Burnout Is Real — Make Self-Care a Priority 

As a retired physician who spent 40 years practicing medicine, Remignanti experienced the evolution of healthcare as it has become what he calls a “consumer-provider” model. “Productivity didn’t use to be part of the equation, but now it’s the focus,” he said. 

The result is burnout, a very real threat to incoming physicians. Remignanti holds that if you are aware of the risk, you can resist it. Part of avoiding burnout is self-care, according to Ungerleider. “The sooner you prioritize your mental, emotional, and physical well-being, the better,” she said. “Balancing work and life may feel impossible at times but taking care of yourself is essential to being a better physician in the long run.”

That means carving out time for exercise, hobbies, and connections outside of the medical field. It also means making sleep and nutrition a priority, even when that feels hard to accomplish. “If you don’t take care of yourself, you can’t take care of others,” added Opris. “It’s so common to lose yourself in your career, but you need to hold onto your physical, emotional, and spiritual self.”

 

Avoid Relying Too Heavily on Tech

Technology is invading every aspect of our lives — often for the greater good — but in medicine, it’s important to always return to your core knowledge above all else. Case in point, said Opris, the UpToDate app. While it can be a useful tool, it’s important not to become too reliant on it. “UpToDate is expert opinion-based guidance, and it’s a fantastic resource,” he said. “But you need to use your references and knowledge in every case.”

It’s key to remember that every patient is different, and their case may not line up perfectly with the guidance presented in UpToDate or other technology source. Piggybacking on that, Ungerleider added that it’s important to remember medicine is about people, not just conditions.

“It’s easy to focus on mastering the science, but the real art of medicine comes from seeing the whole person in front of you,” she said. “Your patients are more than their diagnoses — they come with complex emotions, life stories, and needs.” Being compassionate, listening carefully, and building trust should match up to your clinical skills.

 

Partner With Your Patients, Even When It’s Difficult

Perhaps the most difficult lesson of all is remembering that your patients may not always agree with your recommendations and choose to ignore them. After all your years spent learning, there may be times when it feels your education is going to waste.

“Remember that the landscape today is so varied, and that bleeds into medicine,” said Opris. “We go into cases with our own biases, and it’s important to take a step back to reset, every time.”

Opris reminds himself of Sir William Osler’s famous essay, “Aequanimitas,” in which he tells graduating medical students to practice with “coolness and presence of mind under all circumstances.”

Remignanti offers this advice: “Physicians need to be able to partner with their patients and jointly decide which courses of action are most effective,” he said. “Cling to the idea that you are forming a partnership with your patients — what can we together determine is the best course?”

At the same time, the path the patient chooses may not be what’s best for them — potentially even leading to a poor outcome.

“You may not always understand their choices,” said Opris. “But they do have a choice. Think of yourself almost like a consultant.”

 

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

Despite 4 years of med school and 3-7 years in residency, when you enter the workforce as a doctor, you still have much to learn. There is only so much your professors and attending physicians can pack in. Going forward, you’ll continue to learn on the job and via continuing education.

Some of that lifelong learning will involve soft skills — how to compassionately work with your patients and their families, for instance. Other lessons will get down to the business of medicine — the paperwork, the work/life balance, and the moral dilemmas you never saw coming. And still others will involve learning how to take care of yourself in the middle of seemingly endless hours on the job.

“We all have things we wish we had known upon starting our careers,” said Daniel Opris, MD, a primary care physician at Ohio-based Executive Medical Centers.

We tapped several veteran physicians and an educator to learn what they wish med students knew as they enter the workforce. We’ve compiled them here to give you a head start on the lessons ahead. 

 

You Won’t Know Everything, and That’s Okay

When you go through your medical training, it can feel overwhelming to absorb all the knowledge your professors and attendings impart. The bottom line, said Shoshana Ungerleider, MD, an internal medicine specialist, is that you shouldn’t worry about it.

“No one expects you to know it all,” she explained. “What’s important is to cultivate curiosity and a willingness to ask for help when needed.” 

David Lenihan, PhD, CEO at Ponce Health Sciences University, agrees. “What we’ve lost in recent years, is the ability to apply your skill set and say, ‘let me take a day and get back to you,’” he said. “Doctors love it when you do that because it shows you can pitch in and work as part of a team.”

Medicine is a collaborative field, said Ungerleider, and learning from others, whether peers, nurses, or specialists, is “not a weakness.” She recommends embracing uncertainty and getting comfortable with the unknown.

 

You’ll Take Your Work Home With You

Doctors enter the field because they care about their patients and want to help. Successful outcomes are never guaranteed, however, no matter how much you try. The result? Some days you’ll bring home those upsetting and haunting cases, said Lenihan. 

“We often believe that we should leave our work at the office, but sometimes you need to bring it home and think it through,” he said. “It can’t overwhelm you, but you should digest what happened.”

When you do, said Lenihan, you’ll come out the other end more empathetic and that helps the healthcare system in the long run. “The more you reflect on your day, the better you’ll get at reading the room and treating your patients.”

Drew Remignanti, MD, a retired emergency medicine physician from New Hampshire, agrees, but puts a different spin on bringing work home. 

“We revisit the patient care decisions we made, second-guess ourselves, and worry about our patients’ welfare and outcomes,” he said. “I think it can only lead to better outcomes down the road, however, if you learn from that bad decision, preventing you from committing a similar mistake.”

 

Burnout Is Real — Make Self-Care a Priority 

As a retired physician who spent 40 years practicing medicine, Remignanti experienced the evolution of healthcare as it has become what he calls a “consumer-provider” model. “Productivity didn’t use to be part of the equation, but now it’s the focus,” he said. 

The result is burnout, a very real threat to incoming physicians. Remignanti holds that if you are aware of the risk, you can resist it. Part of avoiding burnout is self-care, according to Ungerleider. “The sooner you prioritize your mental, emotional, and physical well-being, the better,” she said. “Balancing work and life may feel impossible at times but taking care of yourself is essential to being a better physician in the long run.”

That means carving out time for exercise, hobbies, and connections outside of the medical field. It also means making sleep and nutrition a priority, even when that feels hard to accomplish. “If you don’t take care of yourself, you can’t take care of others,” added Opris. “It’s so common to lose yourself in your career, but you need to hold onto your physical, emotional, and spiritual self.”

 

Avoid Relying Too Heavily on Tech

Technology is invading every aspect of our lives — often for the greater good — but in medicine, it’s important to always return to your core knowledge above all else. Case in point, said Opris, the UpToDate app. While it can be a useful tool, it’s important not to become too reliant on it. “UpToDate is expert opinion-based guidance, and it’s a fantastic resource,” he said. “But you need to use your references and knowledge in every case.”

It’s key to remember that every patient is different, and their case may not line up perfectly with the guidance presented in UpToDate or other technology source. Piggybacking on that, Ungerleider added that it’s important to remember medicine is about people, not just conditions.

“It’s easy to focus on mastering the science, but the real art of medicine comes from seeing the whole person in front of you,” she said. “Your patients are more than their diagnoses — they come with complex emotions, life stories, and needs.” Being compassionate, listening carefully, and building trust should match up to your clinical skills.

 

Partner With Your Patients, Even When It’s Difficult

Perhaps the most difficult lesson of all is remembering that your patients may not always agree with your recommendations and choose to ignore them. After all your years spent learning, there may be times when it feels your education is going to waste.

“Remember that the landscape today is so varied, and that bleeds into medicine,” said Opris. “We go into cases with our own biases, and it’s important to take a step back to reset, every time.”

Opris reminds himself of Sir William Osler’s famous essay, “Aequanimitas,” in which he tells graduating medical students to practice with “coolness and presence of mind under all circumstances.”

Remignanti offers this advice: “Physicians need to be able to partner with their patients and jointly decide which courses of action are most effective,” he said. “Cling to the idea that you are forming a partnership with your patients — what can we together determine is the best course?”

At the same time, the path the patient chooses may not be what’s best for them — potentially even leading to a poor outcome.

“You may not always understand their choices,” said Opris. “But they do have a choice. Think of yourself almost like a consultant.”

 

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