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

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

New Screening Option

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

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

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

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

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

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

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

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

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

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

Recommendations for Screening (Based on Grade A Evidence):

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

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

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

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

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

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

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

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

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

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

New Screening Option

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

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

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

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

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

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

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

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

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

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

Recommendations for Screening (Based on Grade A Evidence):

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

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

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

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

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

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

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

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

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

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

New Screening Option

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

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

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

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

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

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

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

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

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

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

Recommendations for Screening (Based on Grade A Evidence):

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

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

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

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

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

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

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

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

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

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

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

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

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

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

C. Consider prescribing a selective serotonin reuptake inhibitor

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

Dr. Vega’s Take

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

C. Consider prescribing a selective serotonin reuptake inhibitor

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

Dr. Vega’s Take

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

C. Consider prescribing a selective serotonin reuptake inhibitor

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

Dr. Vega’s Take

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

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

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

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

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

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

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

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

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

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.

More than a third of all patients with cancer die in hospitals, a figure that has increased slightly in recent years, while deaths at home have decreased. These findings come from a recent study published in Cancer Epidemiology, which analyzed data on the different places in Italy where end of life occurs.

“Place of death is relevant both for individuals and for the society. Home is universally considered the optimal place of death, while dying in a hospital may be a signal of inappropriate end-of-life care,” wrote the authors, led by Gianmauro Numico, MD, head of the Oncology Department at the Santa Croce e Carle General Hospital in Cuneo, Italy.

“Despite the general trend toward strengthening community-based networks and the increasing number of hospice and long-term care facilities, we oncologists are facing an opposite trend, with many patients spending their last days in the hospital,” Numico explained to Univadis Italy. This observation led to the questions that prompted the study: Is this only a perception among doctors, or is it a real phenomenon? If the latter, why is it happening? As the expert points out, it is a commonly held belief that people today should not die in the hospital, and numerous studies conducted on healthy individuals suggest that 70%-80% of the population would prefer to die at home.

 

What’s Preferable

For their analysis, Numico and colleagues relied on death certificates published by the Italian National Institute of Statistics from 2015 to 2019, excluding data from the pandemic years to avoid potential biases.

The analysis of data pertaining to cancer deaths revealed that approximately 35% of Italian patients with cancer die in hospitals, with a slight increase over the study period. Of the patients who die elsewhere, 40% die at home and 20% die in hospice or other long-term care facilities. Home deaths have decreased by 3.09%, while those in hospices and long-term care facilities have increased by 2.71%, and hospital deaths have risen by 0.3%.

The study also highlighted notable geographical differences: Hospital deaths are more frequent in the north, while in the south, home deaths remain predominant, although hospital admissions are on the rise. “These differences reflect not only access to facilities but also cultural and social variables,” explained Numico. “Some end-of-life issues with cancer patients are more straightforward, while others are difficult to manage outside the hospital,” he said, recalling that many family members and caregivers are afraid they won’t be able to care for their loved ones properly without the support of an appropriate facility and skilled personnel.

Social factors also contribute to the increased use of hospitals for end-of-life care: Without a social and family network, it is often impossible to manage the final stages of life at home. “We cannot guarantee that dying at home is better for everyone; in some cases, the home cannot provide the necessary care and emotional support,” Numico added.

 

Attitudes Need Change

Looking beyond Italy, it is clear that this trend exists in other countries as well. For example, in the Netherlands — where community-based care is highly developed and includes practices such as euthanasia — hospital death rates are higher than those in Italy. In the United States, the trend is different, but this is largely due to the structure of the US healthcare system, where patients bear much of the financial burden of hospital admissions.

“The basic requests of patients and families are clear: They want a safe place that is adequately staffed and where the patient won’t suffer,” said Numico, questioning whether the home is truly the best place to die. “In reality, this is not always the case, and it’s important to focus on the quality of care in the final days rather than just the place of care,” he added.

Ruling out hospitals a priori as a place to die is not a winning strategy, according to the expert. Instead of trying to reverse the trend, he suggests integrating the hospital into a care network that prioritizes the patient’s well-being, regardless of the setting. “Our goal should not be to eliminate hospital deaths — a common request from hospital administrations — but rather to ensure that end-of-life care in hospitals is a dignified experience that respects the needs of the dying and their loved ones,” Numico said. “We must ensure that, wherever the end-of-life process occurs, it should happen in the best way possible, and the hospital must be a part of this overall framework,” he concluded.

This story was translated from Univadis Italy 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.

More than a third of all patients with cancer die in hospitals, a figure that has increased slightly in recent years, while deaths at home have decreased. These findings come from a recent study published in Cancer Epidemiology, which analyzed data on the different places in Italy where end of life occurs.

“Place of death is relevant both for individuals and for the society. Home is universally considered the optimal place of death, while dying in a hospital may be a signal of inappropriate end-of-life care,” wrote the authors, led by Gianmauro Numico, MD, head of the Oncology Department at the Santa Croce e Carle General Hospital in Cuneo, Italy.

“Despite the general trend toward strengthening community-based networks and the increasing number of hospice and long-term care facilities, we oncologists are facing an opposite trend, with many patients spending their last days in the hospital,” Numico explained to Univadis Italy. This observation led to the questions that prompted the study: Is this only a perception among doctors, or is it a real phenomenon? If the latter, why is it happening? As the expert points out, it is a commonly held belief that people today should not die in the hospital, and numerous studies conducted on healthy individuals suggest that 70%-80% of the population would prefer to die at home.

 

What’s Preferable

For their analysis, Numico and colleagues relied on death certificates published by the Italian National Institute of Statistics from 2015 to 2019, excluding data from the pandemic years to avoid potential biases.

The analysis of data pertaining to cancer deaths revealed that approximately 35% of Italian patients with cancer die in hospitals, with a slight increase over the study period. Of the patients who die elsewhere, 40% die at home and 20% die in hospice or other long-term care facilities. Home deaths have decreased by 3.09%, while those in hospices and long-term care facilities have increased by 2.71%, and hospital deaths have risen by 0.3%.

The study also highlighted notable geographical differences: Hospital deaths are more frequent in the north, while in the south, home deaths remain predominant, although hospital admissions are on the rise. “These differences reflect not only access to facilities but also cultural and social variables,” explained Numico. “Some end-of-life issues with cancer patients are more straightforward, while others are difficult to manage outside the hospital,” he said, recalling that many family members and caregivers are afraid they won’t be able to care for their loved ones properly without the support of an appropriate facility and skilled personnel.

Social factors also contribute to the increased use of hospitals for end-of-life care: Without a social and family network, it is often impossible to manage the final stages of life at home. “We cannot guarantee that dying at home is better for everyone; in some cases, the home cannot provide the necessary care and emotional support,” Numico added.

 

Attitudes Need Change

Looking beyond Italy, it is clear that this trend exists in other countries as well. For example, in the Netherlands — where community-based care is highly developed and includes practices such as euthanasia — hospital death rates are higher than those in Italy. In the United States, the trend is different, but this is largely due to the structure of the US healthcare system, where patients bear much of the financial burden of hospital admissions.

“The basic requests of patients and families are clear: They want a safe place that is adequately staffed and where the patient won’t suffer,” said Numico, questioning whether the home is truly the best place to die. “In reality, this is not always the case, and it’s important to focus on the quality of care in the final days rather than just the place of care,” he added.

Ruling out hospitals a priori as a place to die is not a winning strategy, according to the expert. Instead of trying to reverse the trend, he suggests integrating the hospital into a care network that prioritizes the patient’s well-being, regardless of the setting. “Our goal should not be to eliminate hospital deaths — a common request from hospital administrations — but rather to ensure that end-of-life care in hospitals is a dignified experience that respects the needs of the dying and their loved ones,” Numico said. “We must ensure that, wherever the end-of-life process occurs, it should happen in the best way possible, and the hospital must be a part of this overall framework,” he concluded.

This story was translated from Univadis Italy 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.

More than a third of all patients with cancer die in hospitals, a figure that has increased slightly in recent years, while deaths at home have decreased. These findings come from a recent study published in Cancer Epidemiology, which analyzed data on the different places in Italy where end of life occurs.

“Place of death is relevant both for individuals and for the society. Home is universally considered the optimal place of death, while dying in a hospital may be a signal of inappropriate end-of-life care,” wrote the authors, led by Gianmauro Numico, MD, head of the Oncology Department at the Santa Croce e Carle General Hospital in Cuneo, Italy.

“Despite the general trend toward strengthening community-based networks and the increasing number of hospice and long-term care facilities, we oncologists are facing an opposite trend, with many patients spending their last days in the hospital,” Numico explained to Univadis Italy. This observation led to the questions that prompted the study: Is this only a perception among doctors, or is it a real phenomenon? If the latter, why is it happening? As the expert points out, it is a commonly held belief that people today should not die in the hospital, and numerous studies conducted on healthy individuals suggest that 70%-80% of the population would prefer to die at home.

 

What’s Preferable

For their analysis, Numico and colleagues relied on death certificates published by the Italian National Institute of Statistics from 2015 to 2019, excluding data from the pandemic years to avoid potential biases.

The analysis of data pertaining to cancer deaths revealed that approximately 35% of Italian patients with cancer die in hospitals, with a slight increase over the study period. Of the patients who die elsewhere, 40% die at home and 20% die in hospice or other long-term care facilities. Home deaths have decreased by 3.09%, while those in hospices and long-term care facilities have increased by 2.71%, and hospital deaths have risen by 0.3%.

The study also highlighted notable geographical differences: Hospital deaths are more frequent in the north, while in the south, home deaths remain predominant, although hospital admissions are on the rise. “These differences reflect not only access to facilities but also cultural and social variables,” explained Numico. “Some end-of-life issues with cancer patients are more straightforward, while others are difficult to manage outside the hospital,” he said, recalling that many family members and caregivers are afraid they won’t be able to care for their loved ones properly without the support of an appropriate facility and skilled personnel.

Social factors also contribute to the increased use of hospitals for end-of-life care: Without a social and family network, it is often impossible to manage the final stages of life at home. “We cannot guarantee that dying at home is better for everyone; in some cases, the home cannot provide the necessary care and emotional support,” Numico added.

 

Attitudes Need Change

Looking beyond Italy, it is clear that this trend exists in other countries as well. For example, in the Netherlands — where community-based care is highly developed and includes practices such as euthanasia — hospital death rates are higher than those in Italy. In the United States, the trend is different, but this is largely due to the structure of the US healthcare system, where patients bear much of the financial burden of hospital admissions.

“The basic requests of patients and families are clear: They want a safe place that is adequately staffed and where the patient won’t suffer,” said Numico, questioning whether the home is truly the best place to die. “In reality, this is not always the case, and it’s important to focus on the quality of care in the final days rather than just the place of care,” he added.

Ruling out hospitals a priori as a place to die is not a winning strategy, according to the expert. Instead of trying to reverse the trend, he suggests integrating the hospital into a care network that prioritizes the patient’s well-being, regardless of the setting. “Our goal should not be to eliminate hospital deaths — a common request from hospital administrations — but rather to ensure that end-of-life care in hospitals is a dignified experience that respects the needs of the dying and their loved ones,” Numico said. “We must ensure that, wherever the end-of-life process occurs, it should happen in the best way possible, and the hospital must be a part of this overall framework,” he concluded.

This story was translated from Univadis Italy 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.

Daniel C. Butler, MD, is associate professor of dermatology and director of the new Inflammatory and Aging Skin Research Program in the Division of Dermatology at the University of Arizona College of Medicine, Tucson, Arizona. Before returning to Arizona, where he had attended medical school, Butler practiced and was a researcher at the University of California, San Francisco, and its geriatric dermatology clinic. He is a co-founder and continues to co-lead the American Academy of Dermatology (AAD) Geriatric Dermatology Expert Resource Group (ERG).

Butler’s interest in geriatric dermatology is rooted in his experience growing up with four grandparents and witnessing their wisdom, relationships, moments with loved ones, and other unique and desirable parts of growing old. “When I looked later at how aging was perceived in dermatology, I found it was a lot about ‘antiaging,’” he told this news organization. “I thought there was a needed voice in dermatology for healthy aging, for all the desirable things that only growing old can provide, along with all the incredible ‘antiaging’ things we can do.”

In interviews, Butler spoke about research priorities in geriatric dermatology, how the “4M” model of geriatrics should be applied within dermatology, how dermatologists can best work with older complex patients, and more. The conversation was edited for clarity and length.

 

What is geriatric dermatology? It is described by the AAD’s Geriatric Dermatology ERG as “an emerging subspecialty.” Yet it’s also viewed more broadly. Please speak about its various identities and meanings and its importance for dermatology.

I’d describe geriatric dermatology as a “supra-specialty” in theory because it encapsulates a part of many practices. If you’re a general dermatologist, about 50% of your patients are over the age of 65. If you’re a Mohs surgeon, you’re seeing a strong majority of over 65 patients. And in various specialty clinics, such as inflammatory skin disease, geriatric dermatology pertains to you. In many ways, it can be viewed as a mindset.

From a framework standpoint, and as a field, geriatric dermatology is a basic science initiative, a clinical initiative, an educational initiative, and an advocacy initiative. The goal is to be able to influence, grow, and learn in each of these categories for our older patients. This is happening: Research in this field has progressed, and education has progressed, which has driven some progress in clinical care.

 

How has research progressed in the basic science of aging skin? What are key questions for dermatology?

There has been a lot of basic science research on aging skin and on how an aging immune system, for instance, is reflected in conditions such as bullous pemphigoid, atopic dermatitis (AD), and chronic itch. But aging involves more than immunosenescence. I think of aging skin as a three-headed monster that involves changes in the skin barrier and the microbiome as well. But is there a primary piece of aging in the skin? What comes first or influences the other? More research on these questions can potentially influence our treatments.

With respect to the immune system, what we’re finding in the skin is that age-related change is not a decline in the immune system per se, but rather aberrance in response. Parts of the system tend to become overactive, with a skew toward overexpression of type 2 inflammation. This can be problematic, driving conditions such as chronic itch.

With respect to the skin barrier, we lose essential fatty acids, and we lose a lot of our recovery ability and our ability to respond quickly to environmental stressors. But are barrier changes triggering the immune system? Or is it the other way around?

The microbiome, which is a big focus of research, involves similar chicken-and-egg discussions. Is it the microbiome that changes and alters the barrier, which then entices the immune system? Which one happens first? We have a lot to learn, and there’s probably not one answer for every patient.

 

Please speak about research more broadly. What questions and issues need to be answered and addressed to improve the dermatologic care of older adults?

In general, research in dermatology is very disease-specific and not particularly conducive to looking at the larger demographic populations. We have a huge opportunity, therefore, to break the mold and grow geriatric dermatology as an area of population-based research — so that geriatric dermatology research encompasses not only the melanoma researcher who’s trying to understand how aging influences the melanocytes but also the epidemiologic researcher looking at how our diagnoses and coding and prescription practices are different in the 65-plus age group.

Clinically speaking, researchers want to better understand how aging influences the clinical presentations of our diseases. And there’s research to be done on best practices. For example, what are the best practices for treating basal cell carcinomas in patients with mild cognitive impairment? How should we consider the use of topicals in a patient who has severe arthritis or who lives alone? And then how should we teach practical approaches to help providers meet people where they are?

Looking at it from a healthcare system standpoint, there are many care delivery and access issues — practical pieces — to research, and we’re getting a lot better with this. We’re also advocating not only for more inclusion of older adults in clinical trials of treatments but also for the use of evaluations and outcomes that are relevant and important for older adults.

One piece of good news is that we’re seeing safer treatment options with tremendous efficacy that target known pathways for diseases like AD and chronic itch that affect older adults. Again, now we must find ways to improve access to these novel, safe options.

Our research program at the University of Arizona College of Medicine, which we’re just getting off the ground, aims to be dual-sided, looking both at the basic science of aging skin and at access and care delivery issues, such as how to ensure that patients on Medicare have access to medications that are at least on par with others with private insurance.

 

What are the most common dermatologic problems experienced by older adults?

Based on my experience and on research that we expect to be published soon, it’s absolutely nonmelanoma skin cancers, precancers like actinic keratoses — and on the inflammatory disease side, itch, AD, and psoriasis. Of course, also common are the age-related changes to the skin that we put in the benign category, such as solar lentigines.

How does age influence dermatologic diseases from a pathophysiological and clinical standpoint?

Diseases overall are very similar and respond to the same treatments, but age in and of itself does influence little pieces. For example, there is more crossover in the presentation of psoriasis and AD in older adults, leading to delays in the diagnosis of psoriasis.

With AD, we’ve found that itch is the predominant symptom for older adults rather than the red rash. We see higher or more severe itch scores in older adults with AD with less visual changes on the skin than in younger cohorts. And rash occurs in different locations than in young patients. Older adults typically present with it on their chest, back, and across the trunk, rather than in folded areas. They’re also more likely to get it on their legs in a nummular pattern as opposed to the more traditional flexural area presentation.

 

What unique considerations need to be made in treating older adults? How should the 4M model of geriatrics be applied to dermatologic care?

Our care model pushes us to be very algorithmic, but at the end of the day, what’s really important are the 4Ms: Mobility, medication, mentation, and “what matters most.” As you’re having your shared decision-making conversations with your patients and their families, these should be your priorities.

A patient with physical limitations, for instance, may not be able to apply a topical cream twice a day all over the body. They may have comorbidities and treatments for these comorbidities that may conflict with medications you’re considering.

And then mentation is so important. For a long time, we used antihistamines for older adults, but this has been proven to be bad for their mentation and risky in other ways. We need to be sure we’re prioritizing their ability to be clear mentally when we’re prescribing medications and even when we’re considering surgical approaches. Do they show capacity for that procedure or treatment, and how will they respond to that treatment later on?

Using the 4M model to drive conversations is a way to get all of us to connect to the patient and learn about what’s most important for them. In many ways, geriatrics is about taking a step back from your specialist skills and thinking about how you would want a family member treated.

We want to avoid treating just the lesion or the pathologic diagnosis. We want to avoid the “conveyor belt” from a biopsy to Mohs. I have 95-year-olds who say, “Heck yeah, if Mohs is the best treatment, that’s what I want.” And I have 70-year-olds who say, “I think I’ll go with another option,” and that’s the right decision for them. It’s having the conversation that matters.

 

In practice, given time constraints and other confines, how can dermatologists best work with more complex older patients? What are your practical tips?

People talk about having 45-minute “golden year” conversations with their older patients, but it doesn’t have to be this way. In pursuing geriatric dermatology, I decided early on that I wanted to make sure it was practical, so I’ve focused on maximizing shorter visits and on embracing the concept that relationships can be developed over time. Each time we meet with someone, we’re building equity to have bigger conversations later on.

I can have a 15-minute conversation about whether my patient may want to have Mohs surgery, for instance, or escalate treatment to a systemic agent for their chronic inflammatory disease. If that time isn’t enough, I can encourage further thought about treatment options, acknowledge that decisions aren’t necessarily easy, and schedule a follow-up or offer to call the patient after clinic to continue the conversation.

Sometimes, when I’m at an impasse and my patient is unsure how to proceed, I’ll use clear metrics relevant to older adults — sleep, activity level, and caregiver burden — to help my patient. If someone is not sleeping because of their lesion — if they’re so itchy or their inflammatory disease is uncontrolled, for instance — I’ll point out that the side effects of not sleeping are worse than the medications or surgery we’d pursue. If someone removes themselves from an activity due to their skin condition, that’s a red flag. And if the caregiver in the room is overwhelmed or frustrated by having to put cream on twice a day, I’ll use this to advance treatment.

 

What resources are available for dermatologists interested in improving their geriatric dermatology skills or advancing the area?

For those interested in investigating these issues or improving their practices, the AAD’s Geriatric Dermatology ERG is always welcoming of new members. The ERG will have an all-inclusive meeting at the 2025 annual AAD meeting in March.

The AAD also has educational modules on geriatric dermatology that were recently published as an initiative of our ERG. More information is available on the website. Also valuable is the ElderDerm conference hosted by the George Washington University School of Medicine and Health Sciences, Washington, DC; the second such conference takes place in May 2025.

Butler reported that he had no relevant financial disclosures.

 

A version of this article appeared on Medscape.com.

Daniel C. Butler, MD, is associate professor of dermatology and director of the new Inflammatory and Aging Skin Research Program in the Division of Dermatology at the University of Arizona College of Medicine, Tucson, Arizona. Before returning to Arizona, where he had attended medical school, Butler practiced and was a researcher at the University of California, San Francisco, and its geriatric dermatology clinic. He is a co-founder and continues to co-lead the American Academy of Dermatology (AAD) Geriatric Dermatology Expert Resource Group (ERG).

Butler’s interest in geriatric dermatology is rooted in his experience growing up with four grandparents and witnessing their wisdom, relationships, moments with loved ones, and other unique and desirable parts of growing old. “When I looked later at how aging was perceived in dermatology, I found it was a lot about ‘antiaging,’” he told this news organization. “I thought there was a needed voice in dermatology for healthy aging, for all the desirable things that only growing old can provide, along with all the incredible ‘antiaging’ things we can do.”

In interviews, Butler spoke about research priorities in geriatric dermatology, how the “4M” model of geriatrics should be applied within dermatology, how dermatologists can best work with older complex patients, and more. The conversation was edited for clarity and length.

 

What is geriatric dermatology? It is described by the AAD’s Geriatric Dermatology ERG as “an emerging subspecialty.” Yet it’s also viewed more broadly. Please speak about its various identities and meanings and its importance for dermatology.

I’d describe geriatric dermatology as a “supra-specialty” in theory because it encapsulates a part of many practices. If you’re a general dermatologist, about 50% of your patients are over the age of 65. If you’re a Mohs surgeon, you’re seeing a strong majority of over 65 patients. And in various specialty clinics, such as inflammatory skin disease, geriatric dermatology pertains to you. In many ways, it can be viewed as a mindset.

From a framework standpoint, and as a field, geriatric dermatology is a basic science initiative, a clinical initiative, an educational initiative, and an advocacy initiative. The goal is to be able to influence, grow, and learn in each of these categories for our older patients. This is happening: Research in this field has progressed, and education has progressed, which has driven some progress in clinical care.

 

How has research progressed in the basic science of aging skin? What are key questions for dermatology?

There has been a lot of basic science research on aging skin and on how an aging immune system, for instance, is reflected in conditions such as bullous pemphigoid, atopic dermatitis (AD), and chronic itch. But aging involves more than immunosenescence. I think of aging skin as a three-headed monster that involves changes in the skin barrier and the microbiome as well. But is there a primary piece of aging in the skin? What comes first or influences the other? More research on these questions can potentially influence our treatments.

With respect to the immune system, what we’re finding in the skin is that age-related change is not a decline in the immune system per se, but rather aberrance in response. Parts of the system tend to become overactive, with a skew toward overexpression of type 2 inflammation. This can be problematic, driving conditions such as chronic itch.

With respect to the skin barrier, we lose essential fatty acids, and we lose a lot of our recovery ability and our ability to respond quickly to environmental stressors. But are barrier changes triggering the immune system? Or is it the other way around?

The microbiome, which is a big focus of research, involves similar chicken-and-egg discussions. Is it the microbiome that changes and alters the barrier, which then entices the immune system? Which one happens first? We have a lot to learn, and there’s probably not one answer for every patient.

 

Please speak about research more broadly. What questions and issues need to be answered and addressed to improve the dermatologic care of older adults?

In general, research in dermatology is very disease-specific and not particularly conducive to looking at the larger demographic populations. We have a huge opportunity, therefore, to break the mold and grow geriatric dermatology as an area of population-based research — so that geriatric dermatology research encompasses not only the melanoma researcher who’s trying to understand how aging influences the melanocytes but also the epidemiologic researcher looking at how our diagnoses and coding and prescription practices are different in the 65-plus age group.

Clinically speaking, researchers want to better understand how aging influences the clinical presentations of our diseases. And there’s research to be done on best practices. For example, what are the best practices for treating basal cell carcinomas in patients with mild cognitive impairment? How should we consider the use of topicals in a patient who has severe arthritis or who lives alone? And then how should we teach practical approaches to help providers meet people where they are?

Looking at it from a healthcare system standpoint, there are many care delivery and access issues — practical pieces — to research, and we’re getting a lot better with this. We’re also advocating not only for more inclusion of older adults in clinical trials of treatments but also for the use of evaluations and outcomes that are relevant and important for older adults.

One piece of good news is that we’re seeing safer treatment options with tremendous efficacy that target known pathways for diseases like AD and chronic itch that affect older adults. Again, now we must find ways to improve access to these novel, safe options.

Our research program at the University of Arizona College of Medicine, which we’re just getting off the ground, aims to be dual-sided, looking both at the basic science of aging skin and at access and care delivery issues, such as how to ensure that patients on Medicare have access to medications that are at least on par with others with private insurance.

 

What are the most common dermatologic problems experienced by older adults?

Based on my experience and on research that we expect to be published soon, it’s absolutely nonmelanoma skin cancers, precancers like actinic keratoses — and on the inflammatory disease side, itch, AD, and psoriasis. Of course, also common are the age-related changes to the skin that we put in the benign category, such as solar lentigines.

How does age influence dermatologic diseases from a pathophysiological and clinical standpoint?

Diseases overall are very similar and respond to the same treatments, but age in and of itself does influence little pieces. For example, there is more crossover in the presentation of psoriasis and AD in older adults, leading to delays in the diagnosis of psoriasis.

With AD, we’ve found that itch is the predominant symptom for older adults rather than the red rash. We see higher or more severe itch scores in older adults with AD with less visual changes on the skin than in younger cohorts. And rash occurs in different locations than in young patients. Older adults typically present with it on their chest, back, and across the trunk, rather than in folded areas. They’re also more likely to get it on their legs in a nummular pattern as opposed to the more traditional flexural area presentation.

 

What unique considerations need to be made in treating older adults? How should the 4M model of geriatrics be applied to dermatologic care?

Our care model pushes us to be very algorithmic, but at the end of the day, what’s really important are the 4Ms: Mobility, medication, mentation, and “what matters most.” As you’re having your shared decision-making conversations with your patients and their families, these should be your priorities.

A patient with physical limitations, for instance, may not be able to apply a topical cream twice a day all over the body. They may have comorbidities and treatments for these comorbidities that may conflict with medications you’re considering.

And then mentation is so important. For a long time, we used antihistamines for older adults, but this has been proven to be bad for their mentation and risky in other ways. We need to be sure we’re prioritizing their ability to be clear mentally when we’re prescribing medications and even when we’re considering surgical approaches. Do they show capacity for that procedure or treatment, and how will they respond to that treatment later on?

Using the 4M model to drive conversations is a way to get all of us to connect to the patient and learn about what’s most important for them. In many ways, geriatrics is about taking a step back from your specialist skills and thinking about how you would want a family member treated.

We want to avoid treating just the lesion or the pathologic diagnosis. We want to avoid the “conveyor belt” from a biopsy to Mohs. I have 95-year-olds who say, “Heck yeah, if Mohs is the best treatment, that’s what I want.” And I have 70-year-olds who say, “I think I’ll go with another option,” and that’s the right decision for them. It’s having the conversation that matters.

 

In practice, given time constraints and other confines, how can dermatologists best work with more complex older patients? What are your practical tips?

People talk about having 45-minute “golden year” conversations with their older patients, but it doesn’t have to be this way. In pursuing geriatric dermatology, I decided early on that I wanted to make sure it was practical, so I’ve focused on maximizing shorter visits and on embracing the concept that relationships can be developed over time. Each time we meet with someone, we’re building equity to have bigger conversations later on.

I can have a 15-minute conversation about whether my patient may want to have Mohs surgery, for instance, or escalate treatment to a systemic agent for their chronic inflammatory disease. If that time isn’t enough, I can encourage further thought about treatment options, acknowledge that decisions aren’t necessarily easy, and schedule a follow-up or offer to call the patient after clinic to continue the conversation.

Sometimes, when I’m at an impasse and my patient is unsure how to proceed, I’ll use clear metrics relevant to older adults — sleep, activity level, and caregiver burden — to help my patient. If someone is not sleeping because of their lesion — if they’re so itchy or their inflammatory disease is uncontrolled, for instance — I’ll point out that the side effects of not sleeping are worse than the medications or surgery we’d pursue. If someone removes themselves from an activity due to their skin condition, that’s a red flag. And if the caregiver in the room is overwhelmed or frustrated by having to put cream on twice a day, I’ll use this to advance treatment.

 

What resources are available for dermatologists interested in improving their geriatric dermatology skills or advancing the area?

For those interested in investigating these issues or improving their practices, the AAD’s Geriatric Dermatology ERG is always welcoming of new members. The ERG will have an all-inclusive meeting at the 2025 annual AAD meeting in March.

The AAD also has educational modules on geriatric dermatology that were recently published as an initiative of our ERG. More information is available on the website. Also valuable is the ElderDerm conference hosted by the George Washington University School of Medicine and Health Sciences, Washington, DC; the second such conference takes place in May 2025.

Butler reported that he had no relevant financial disclosures.

 

A version of this article appeared on Medscape.com.

Daniel C. Butler, MD, is associate professor of dermatology and director of the new Inflammatory and Aging Skin Research Program in the Division of Dermatology at the University of Arizona College of Medicine, Tucson, Arizona. Before returning to Arizona, where he had attended medical school, Butler practiced and was a researcher at the University of California, San Francisco, and its geriatric dermatology clinic. He is a co-founder and continues to co-lead the American Academy of Dermatology (AAD) Geriatric Dermatology Expert Resource Group (ERG).

Butler’s interest in geriatric dermatology is rooted in his experience growing up with four grandparents and witnessing their wisdom, relationships, moments with loved ones, and other unique and desirable parts of growing old. “When I looked later at how aging was perceived in dermatology, I found it was a lot about ‘antiaging,’” he told this news organization. “I thought there was a needed voice in dermatology for healthy aging, for all the desirable things that only growing old can provide, along with all the incredible ‘antiaging’ things we can do.”

In interviews, Butler spoke about research priorities in geriatric dermatology, how the “4M” model of geriatrics should be applied within dermatology, how dermatologists can best work with older complex patients, and more. The conversation was edited for clarity and length.

 

What is geriatric dermatology? It is described by the AAD’s Geriatric Dermatology ERG as “an emerging subspecialty.” Yet it’s also viewed more broadly. Please speak about its various identities and meanings and its importance for dermatology.

I’d describe geriatric dermatology as a “supra-specialty” in theory because it encapsulates a part of many practices. If you’re a general dermatologist, about 50% of your patients are over the age of 65. If you’re a Mohs surgeon, you’re seeing a strong majority of over 65 patients. And in various specialty clinics, such as inflammatory skin disease, geriatric dermatology pertains to you. In many ways, it can be viewed as a mindset.

From a framework standpoint, and as a field, geriatric dermatology is a basic science initiative, a clinical initiative, an educational initiative, and an advocacy initiative. The goal is to be able to influence, grow, and learn in each of these categories for our older patients. This is happening: Research in this field has progressed, and education has progressed, which has driven some progress in clinical care.

 

How has research progressed in the basic science of aging skin? What are key questions for dermatology?

There has been a lot of basic science research on aging skin and on how an aging immune system, for instance, is reflected in conditions such as bullous pemphigoid, atopic dermatitis (AD), and chronic itch. But aging involves more than immunosenescence. I think of aging skin as a three-headed monster that involves changes in the skin barrier and the microbiome as well. But is there a primary piece of aging in the skin? What comes first or influences the other? More research on these questions can potentially influence our treatments.

With respect to the immune system, what we’re finding in the skin is that age-related change is not a decline in the immune system per se, but rather aberrance in response. Parts of the system tend to become overactive, with a skew toward overexpression of type 2 inflammation. This can be problematic, driving conditions such as chronic itch.

With respect to the skin barrier, we lose essential fatty acids, and we lose a lot of our recovery ability and our ability to respond quickly to environmental stressors. But are barrier changes triggering the immune system? Or is it the other way around?

The microbiome, which is a big focus of research, involves similar chicken-and-egg discussions. Is it the microbiome that changes and alters the barrier, which then entices the immune system? Which one happens first? We have a lot to learn, and there’s probably not one answer for every patient.

 

Please speak about research more broadly. What questions and issues need to be answered and addressed to improve the dermatologic care of older adults?

In general, research in dermatology is very disease-specific and not particularly conducive to looking at the larger demographic populations. We have a huge opportunity, therefore, to break the mold and grow geriatric dermatology as an area of population-based research — so that geriatric dermatology research encompasses not only the melanoma researcher who’s trying to understand how aging influences the melanocytes but also the epidemiologic researcher looking at how our diagnoses and coding and prescription practices are different in the 65-plus age group.

Clinically speaking, researchers want to better understand how aging influences the clinical presentations of our diseases. And there’s research to be done on best practices. For example, what are the best practices for treating basal cell carcinomas in patients with mild cognitive impairment? How should we consider the use of topicals in a patient who has severe arthritis or who lives alone? And then how should we teach practical approaches to help providers meet people where they are?

Looking at it from a healthcare system standpoint, there are many care delivery and access issues — practical pieces — to research, and we’re getting a lot better with this. We’re also advocating not only for more inclusion of older adults in clinical trials of treatments but also for the use of evaluations and outcomes that are relevant and important for older adults.

One piece of good news is that we’re seeing safer treatment options with tremendous efficacy that target known pathways for diseases like AD and chronic itch that affect older adults. Again, now we must find ways to improve access to these novel, safe options.

Our research program at the University of Arizona College of Medicine, which we’re just getting off the ground, aims to be dual-sided, looking both at the basic science of aging skin and at access and care delivery issues, such as how to ensure that patients on Medicare have access to medications that are at least on par with others with private insurance.

 

What are the most common dermatologic problems experienced by older adults?

Based on my experience and on research that we expect to be published soon, it’s absolutely nonmelanoma skin cancers, precancers like actinic keratoses — and on the inflammatory disease side, itch, AD, and psoriasis. Of course, also common are the age-related changes to the skin that we put in the benign category, such as solar lentigines.

How does age influence dermatologic diseases from a pathophysiological and clinical standpoint?

Diseases overall are very similar and respond to the same treatments, but age in and of itself does influence little pieces. For example, there is more crossover in the presentation of psoriasis and AD in older adults, leading to delays in the diagnosis of psoriasis.

With AD, we’ve found that itch is the predominant symptom for older adults rather than the red rash. We see higher or more severe itch scores in older adults with AD with less visual changes on the skin than in younger cohorts. And rash occurs in different locations than in young patients. Older adults typically present with it on their chest, back, and across the trunk, rather than in folded areas. They’re also more likely to get it on their legs in a nummular pattern as opposed to the more traditional flexural area presentation.

 

What unique considerations need to be made in treating older adults? How should the 4M model of geriatrics be applied to dermatologic care?

Our care model pushes us to be very algorithmic, but at the end of the day, what’s really important are the 4Ms: Mobility, medication, mentation, and “what matters most.” As you’re having your shared decision-making conversations with your patients and their families, these should be your priorities.

A patient with physical limitations, for instance, may not be able to apply a topical cream twice a day all over the body. They may have comorbidities and treatments for these comorbidities that may conflict with medications you’re considering.

And then mentation is so important. For a long time, we used antihistamines for older adults, but this has been proven to be bad for their mentation and risky in other ways. We need to be sure we’re prioritizing their ability to be clear mentally when we’re prescribing medications and even when we’re considering surgical approaches. Do they show capacity for that procedure or treatment, and how will they respond to that treatment later on?

Using the 4M model to drive conversations is a way to get all of us to connect to the patient and learn about what’s most important for them. In many ways, geriatrics is about taking a step back from your specialist skills and thinking about how you would want a family member treated.

We want to avoid treating just the lesion or the pathologic diagnosis. We want to avoid the “conveyor belt” from a biopsy to Mohs. I have 95-year-olds who say, “Heck yeah, if Mohs is the best treatment, that’s what I want.” And I have 70-year-olds who say, “I think I’ll go with another option,” and that’s the right decision for them. It’s having the conversation that matters.

 

In practice, given time constraints and other confines, how can dermatologists best work with more complex older patients? What are your practical tips?

People talk about having 45-minute “golden year” conversations with their older patients, but it doesn’t have to be this way. In pursuing geriatric dermatology, I decided early on that I wanted to make sure it was practical, so I’ve focused on maximizing shorter visits and on embracing the concept that relationships can be developed over time. Each time we meet with someone, we’re building equity to have bigger conversations later on.

I can have a 15-minute conversation about whether my patient may want to have Mohs surgery, for instance, or escalate treatment to a systemic agent for their chronic inflammatory disease. If that time isn’t enough, I can encourage further thought about treatment options, acknowledge that decisions aren’t necessarily easy, and schedule a follow-up or offer to call the patient after clinic to continue the conversation.

Sometimes, when I’m at an impasse and my patient is unsure how to proceed, I’ll use clear metrics relevant to older adults — sleep, activity level, and caregiver burden — to help my patient. If someone is not sleeping because of their lesion — if they’re so itchy or their inflammatory disease is uncontrolled, for instance — I’ll point out that the side effects of not sleeping are worse than the medications or surgery we’d pursue. If someone removes themselves from an activity due to their skin condition, that’s a red flag. And if the caregiver in the room is overwhelmed or frustrated by having to put cream on twice a day, I’ll use this to advance treatment.

 

What resources are available for dermatologists interested in improving their geriatric dermatology skills or advancing the area?

For those interested in investigating these issues or improving their practices, the AAD’s Geriatric Dermatology ERG is always welcoming of new members. The ERG will have an all-inclusive meeting at the 2025 annual AAD meeting in March.

The AAD also has educational modules on geriatric dermatology that were recently published as an initiative of our ERG. More information is available on the website. Also valuable is the ElderDerm conference hosted by the George Washington University School of Medicine and Health Sciences, Washington, DC; the second such conference takes place in May 2025.

Butler reported that he had no relevant financial disclosures.

 

A version of this article appeared on Medscape.com.

SAN DIEGO — A new study linked longer duration and deeper intensity of tobacco smoking to more genetic mutations in myelodysplastic syndromes (MDSs), a group of bone marrow cancers that are similar to acute myeloid leukemia.

The prospective National MDS Natural History Study evaluated 1898 patients with recently diagnosed or suspected MDS. An adjusted analysis linked higher number of pack-years to more mutations (P = .006), with those at the 90th percentile with 3.5 times the number of mutations as nonsmokers, researchers reported at the American Society of Hematology (ASH) 2024 Annual Meeting.

The findings “suggest that smoking potentially contributes to the multistep molecular genetic pathogenesis that ultimately results in diagnosis of the cancer,” said corresponding author Mikkael A. Sekeres, MD, of the Sylvester Comprehensive Cancer Center, University of Miami Health System in Florida, at a news briefing. “The more you smoke, the more likely you are to acquire more mutations and even develop a higher risk of myelodysplastic syndromes. [More smoking] was also associated with progression and survival.”

While numbers are uncertain, an estimated 10,000 or more people in the United States each year are diagnosed with MDS, also known as preleukemia, according to the American Cancer Society. Median survival ranges from 1 to 10.6 years based on risk group, although the cancer society says the statistics are dated and mainly from Europe.

Multiple studies have linked smoking to MDS. The new study aims to understand the possible effects of smoking on genetic mutations.

The research analyzed 1898 patients enrolled from 2016 to 2023 (52% who had ever smoked; 18% current smokers; mean smoking years, 29.8 ± 16.9 years). The patients had diagnoses of MDSs, MDS/myeloproliferative neoplasm overlap, or precursor conditions such as clonal cytopenia of undetermined significance (CCUS).

Smokers were more likely than nonsmokers to be men (68% vs 54%; P < .001) and aged 70-79 years (45% vs 34%; P < .001).

After adjustment for confounders, smokers had more average mutations linked to MDS than nonsmokers (2.0 vs 1.4; P = .04). Those at the 75th percentile of pack-years had 1.8 times as many MDS-linked mutations as nonsmokers.

The 5-year cumulative incidence of disease progression was higher in long-term smokers than in nonsmokers and those with shorter smoking history (mean proportion progressed, 20+ years vs < 20 years smoking/nonsmoking, 27% [19%-36%] vs 18% [13%-24%]; P < .05, respectively).

Also, overall survival was lower in smokers than in nonsmokers for patients with CCUS (hazard ratio [HR], 1.91; 95% CI, 1.03-3.55; P = .04) but not for those with MDS (HR, 1.21; 95% CI, 0.53-1.30; P = .41).

“The data suggests that a patient with a new diagnosis of MDS who also smokes should be counseled to stop smoking,” Sekeres said.

This may seem counterintuitive to patients, he acknowledged. When Sekeres was a medical student, he counseled a female patient with advanced lung cancer to quit smoking. “The patient looked at me like I had three heads and she said: ‘Why should I stop smoking? The cats are already out of the bag. I have lung cancer.’ ”

But the new study points to a possible benefit from quitting smoking while sick. “It appears that smoking contributes to the acquisition of new genetic mutations that can lead to worsening of the myelodysplastic syndromes and even evolution of the cancer into acute myeloid leukemia,” Sekeres said.

He added: “One thing to understand about these cancers of the bone marrow is they can take years or decades to develop. They’re not one-hit wonders. Smoking caused very specific genetic mutations. The cool part of this is that they’re the same genetic mutations smoking has been shown to cause in cancers like lung cancer, so we’re seeing consistency across cancers.”

Sekeres said he himself will counsel patients with MDS or acute myeloid leukemia to stop smoking. “If there’s anything we can do to intervene to prevent myelodysplastic syndrome from evolving into acute leukemia, my word, I sure I’m going to try it.”

In an interview, Peter Greenberg, MD, professor of medicine at Stanford Cancer Center in California, who’s familiar with the study but didn’t take part in the research, said the study suggests that smoking in MDS isn’t just related to exposure to fumes “but appears to be a much more widespread problem” related to its impact on generating hematologic stem cell mutations.

Most clinicians don’t warn patients with MDS about the dangers of smoking because they’re not aware of tobacco’s connection to the disease, Greenberg said. But there’s another reason to bring up smoking, he said: It boosts the risk for cardiovascular disease, which may be partially responsible for decreased survival in smokers.

Sekeres disclosed ties with Kurome, Schrödinger, and Bristol-Myers Squibb. Other authors reported multiple and various relationships with industry. Greenberg had no disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — A new study linked longer duration and deeper intensity of tobacco smoking to more genetic mutations in myelodysplastic syndromes (MDSs), a group of bone marrow cancers that are similar to acute myeloid leukemia.

The prospective National MDS Natural History Study evaluated 1898 patients with recently diagnosed or suspected MDS. An adjusted analysis linked higher number of pack-years to more mutations (P = .006), with those at the 90th percentile with 3.5 times the number of mutations as nonsmokers, researchers reported at the American Society of Hematology (ASH) 2024 Annual Meeting.

The findings “suggest that smoking potentially contributes to the multistep molecular genetic pathogenesis that ultimately results in diagnosis of the cancer,” said corresponding author Mikkael A. Sekeres, MD, of the Sylvester Comprehensive Cancer Center, University of Miami Health System in Florida, at a news briefing. “The more you smoke, the more likely you are to acquire more mutations and even develop a higher risk of myelodysplastic syndromes. [More smoking] was also associated with progression and survival.”

While numbers are uncertain, an estimated 10,000 or more people in the United States each year are diagnosed with MDS, also known as preleukemia, according to the American Cancer Society. Median survival ranges from 1 to 10.6 years based on risk group, although the cancer society says the statistics are dated and mainly from Europe.

Multiple studies have linked smoking to MDS. The new study aims to understand the possible effects of smoking on genetic mutations.

The research analyzed 1898 patients enrolled from 2016 to 2023 (52% who had ever smoked; 18% current smokers; mean smoking years, 29.8 ± 16.9 years). The patients had diagnoses of MDSs, MDS/myeloproliferative neoplasm overlap, or precursor conditions such as clonal cytopenia of undetermined significance (CCUS).

Smokers were more likely than nonsmokers to be men (68% vs 54%; P < .001) and aged 70-79 years (45% vs 34%; P < .001).

After adjustment for confounders, smokers had more average mutations linked to MDS than nonsmokers (2.0 vs 1.4; P = .04). Those at the 75th percentile of pack-years had 1.8 times as many MDS-linked mutations as nonsmokers.

The 5-year cumulative incidence of disease progression was higher in long-term smokers than in nonsmokers and those with shorter smoking history (mean proportion progressed, 20+ years vs < 20 years smoking/nonsmoking, 27% [19%-36%] vs 18% [13%-24%]; P < .05, respectively).

Also, overall survival was lower in smokers than in nonsmokers for patients with CCUS (hazard ratio [HR], 1.91; 95% CI, 1.03-3.55; P = .04) but not for those with MDS (HR, 1.21; 95% CI, 0.53-1.30; P = .41).

“The data suggests that a patient with a new diagnosis of MDS who also smokes should be counseled to stop smoking,” Sekeres said.

This may seem counterintuitive to patients, he acknowledged. When Sekeres was a medical student, he counseled a female patient with advanced lung cancer to quit smoking. “The patient looked at me like I had three heads and she said: ‘Why should I stop smoking? The cats are already out of the bag. I have lung cancer.’ ”

But the new study points to a possible benefit from quitting smoking while sick. “It appears that smoking contributes to the acquisition of new genetic mutations that can lead to worsening of the myelodysplastic syndromes and even evolution of the cancer into acute myeloid leukemia,” Sekeres said.

He added: “One thing to understand about these cancers of the bone marrow is they can take years or decades to develop. They’re not one-hit wonders. Smoking caused very specific genetic mutations. The cool part of this is that they’re the same genetic mutations smoking has been shown to cause in cancers like lung cancer, so we’re seeing consistency across cancers.”

Sekeres said he himself will counsel patients with MDS or acute myeloid leukemia to stop smoking. “If there’s anything we can do to intervene to prevent myelodysplastic syndrome from evolving into acute leukemia, my word, I sure I’m going to try it.”

In an interview, Peter Greenberg, MD, professor of medicine at Stanford Cancer Center in California, who’s familiar with the study but didn’t take part in the research, said the study suggests that smoking in MDS isn’t just related to exposure to fumes “but appears to be a much more widespread problem” related to its impact on generating hematologic stem cell mutations.

Most clinicians don’t warn patients with MDS about the dangers of smoking because they’re not aware of tobacco’s connection to the disease, Greenberg said. But there’s another reason to bring up smoking, he said: It boosts the risk for cardiovascular disease, which may be partially responsible for decreased survival in smokers.

Sekeres disclosed ties with Kurome, Schrödinger, and Bristol-Myers Squibb. Other authors reported multiple and various relationships with industry. Greenberg had no disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — A new study linked longer duration and deeper intensity of tobacco smoking to more genetic mutations in myelodysplastic syndromes (MDSs), a group of bone marrow cancers that are similar to acute myeloid leukemia.

The prospective National MDS Natural History Study evaluated 1898 patients with recently diagnosed or suspected MDS. An adjusted analysis linked higher number of pack-years to more mutations (P = .006), with those at the 90th percentile with 3.5 times the number of mutations as nonsmokers, researchers reported at the American Society of Hematology (ASH) 2024 Annual Meeting.

The findings “suggest that smoking potentially contributes to the multistep molecular genetic pathogenesis that ultimately results in diagnosis of the cancer,” said corresponding author Mikkael A. Sekeres, MD, of the Sylvester Comprehensive Cancer Center, University of Miami Health System in Florida, at a news briefing. “The more you smoke, the more likely you are to acquire more mutations and even develop a higher risk of myelodysplastic syndromes. [More smoking] was also associated with progression and survival.”

While numbers are uncertain, an estimated 10,000 or more people in the United States each year are diagnosed with MDS, also known as preleukemia, according to the American Cancer Society. Median survival ranges from 1 to 10.6 years based on risk group, although the cancer society says the statistics are dated and mainly from Europe.

Multiple studies have linked smoking to MDS. The new study aims to understand the possible effects of smoking on genetic mutations.

The research analyzed 1898 patients enrolled from 2016 to 2023 (52% who had ever smoked; 18% current smokers; mean smoking years, 29.8 ± 16.9 years). The patients had diagnoses of MDSs, MDS/myeloproliferative neoplasm overlap, or precursor conditions such as clonal cytopenia of undetermined significance (CCUS).

Smokers were more likely than nonsmokers to be men (68% vs 54%; P < .001) and aged 70-79 years (45% vs 34%; P < .001).

After adjustment for confounders, smokers had more average mutations linked to MDS than nonsmokers (2.0 vs 1.4; P = .04). Those at the 75th percentile of pack-years had 1.8 times as many MDS-linked mutations as nonsmokers.

The 5-year cumulative incidence of disease progression was higher in long-term smokers than in nonsmokers and those with shorter smoking history (mean proportion progressed, 20+ years vs < 20 years smoking/nonsmoking, 27% [19%-36%] vs 18% [13%-24%]; P < .05, respectively).

Also, overall survival was lower in smokers than in nonsmokers for patients with CCUS (hazard ratio [HR], 1.91; 95% CI, 1.03-3.55; P = .04) but not for those with MDS (HR, 1.21; 95% CI, 0.53-1.30; P = .41).

“The data suggests that a patient with a new diagnosis of MDS who also smokes should be counseled to stop smoking,” Sekeres said.

This may seem counterintuitive to patients, he acknowledged. When Sekeres was a medical student, he counseled a female patient with advanced lung cancer to quit smoking. “The patient looked at me like I had three heads and she said: ‘Why should I stop smoking? The cats are already out of the bag. I have lung cancer.’ ”

But the new study points to a possible benefit from quitting smoking while sick. “It appears that smoking contributes to the acquisition of new genetic mutations that can lead to worsening of the myelodysplastic syndromes and even evolution of the cancer into acute myeloid leukemia,” Sekeres said.

He added: “One thing to understand about these cancers of the bone marrow is they can take years or decades to develop. They’re not one-hit wonders. Smoking caused very specific genetic mutations. The cool part of this is that they’re the same genetic mutations smoking has been shown to cause in cancers like lung cancer, so we’re seeing consistency across cancers.”

Sekeres said he himself will counsel patients with MDS or acute myeloid leukemia to stop smoking. “If there’s anything we can do to intervene to prevent myelodysplastic syndrome from evolving into acute leukemia, my word, I sure I’m going to try it.”

In an interview, Peter Greenberg, MD, professor of medicine at Stanford Cancer Center in California, who’s familiar with the study but didn’t take part in the research, said the study suggests that smoking in MDS isn’t just related to exposure to fumes “but appears to be a much more widespread problem” related to its impact on generating hematologic stem cell mutations.

Most clinicians don’t warn patients with MDS about the dangers of smoking because they’re not aware of tobacco’s connection to the disease, Greenberg said. But there’s another reason to bring up smoking, he said: It boosts the risk for cardiovascular disease, which may be partially responsible for decreased survival in smokers.

Sekeres disclosed ties with Kurome, Schrödinger, and Bristol-Myers Squibb. Other authors reported multiple and various relationships with industry. Greenberg had no disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — Significant complications were common in female patients with sickle cell disease (SCD) who underwent fertility preservation (FP) procedures, and 13% required multiple retrieval cycles, a five-center retrospective study found.

Of 46 patients with SCD, complications occurred in 25 of 55 controlled ovarian hyperstimulation cycles, including 29 vaso-occlusive episodes (VOEs), researchers reported at the American Society of Hematology (ASH) 2024 Annual Meeting.

Of 21 post-retrieval VOEs, 19 required emergency department care or hospitalization.

“Baseline sickle cell disease severity is most likely associated with a patient’s risk of complications from an egg retrieval cycle,” study co-author Sarah Cromack, MD, a reproductive endocrinology and infertility fellow at Northwestern University, Chicago, said in an interview.

“Both hematologists and reproductive endocrinologists can use this information to plan ahead and anticipate possible issues, check blood counts prior to and after egg retrieval to see if transfusion is needed, and plan close follow-up during stimulation and immediately after egg retrieval to evaluate and treat pain.”

 

SCD Accelerates Decline in Ovarian Reserve

Pediatric hematologist Lydia H. Pecker, MD, MS, of Johns Hopkins University School of Medicine, Baltimore, the study’s corresponding author, said in an interview that SCD is “a disease of accelerated aging” that leads to accelerated decline in ovarian reserve. “The common indication for fertility preservation in SCD is before bone marrow transplant or gene therapy,” she said, although FP can also be offered to other patients with SCD.

According to Cromack, researchers launched the study to expand information about SCD and FP in light of sparse data about outcomes.

All the 46 patients had hemoglobin SS (HbSS, 93%) and HbSβ0-thalassemia (7%) and a median age of 23.7 (18-28) years. Almost all (44 patients) underwent FP prior to curative treatments, and all had at least one SCD-related complication, mainly cerebrovascular disease (16), acute chest syndrome (23), and more than two VOEs per year (31).

Median anti-Mullerian hormone (AMH) level (2.1 ng/mL), a measurement of ovarian reserve, was lower than the expected level of 2.8-3.4 ng/mL among women in the age range of the patients, the researchers reported. “This is consistent with previous studies showing lower AMH for age in women with sickle cell disease,” Pecker said.

 

Complications in 45% of Retrieval Cycles

“In terms of success of oocyte cryopreservation, the median number of mature eggs frozen was 11,” said co-author and reproductive endocrinologist Jessica Walter, MD, of Northwestern University, in an interview. “Given the average age of 24 years in the cohort, this would give each patient about a 70% estimated probability of at least one live birth from their cohort of frozen eggs. Thus, patients hoping for more than one child may want to consider more than one cycle of egg freezing.”

The rate of complications was “fairly high” at 45% of all cycles, Walter said. “These were mostly complications from underlying sickle cell disease, including unplanned transfusions and admissions for vaso-occlusive crises. Surprisingly, there were very few cases of ovarian hyperstimulation syndrome in this young patient group, which may be due to a combination of underlying vascular disease, lower peak estradiol levels, and slightly less eggs retrieved then would be expected compared to an age-matched healthy controls.”

Any FP complication was associated with more than three VOEs in the year before controlled ovarian hyperstimulation (mean of three VOEs per patient without complications vs six per patient with complications; P = .036).

 

Higher Than Normal Need for Multiple Cycles

Reproductive endocrinologist H. Irene Su, MD, professor and co-director of the Center for OB/GYN Research Innovations at Moores Cancer Center, University of California San Diego, praised the study as “an important report” in an interview.

Su, who wasn’t involved in the research, said the percentage of patients requiring more than one cycle due to cancellation or low oocyte yield — 13% — is “higher than expected, given the young age of this cohort.”

This could reflect the hypothesis that “sickle cell crises and hypoxia adversely affect the finite number of oocytes in the ovary,” she said.

As for the study findings regarding complications, she said the rate “is very high compared to the general infertility or fertility preservation population. It would be good to learn predictors of these outcomes so that fertility and hematology clinicians can work together to stratify risk and supportive services around FP cycles. It would also be good to know if the post-retrieval VOE were unexpected given the patient’s disease activity prior to FP.”

 

Message: FP in SCD Is Feasible, Acceptable

A.D. Mishkin, MD, MPH, associate professor of psychiatry and liaison to the Blood and Marrow Transplantation Program at NewYork–Presbyterian/Columbia University Irving Medical Center, New York City, said in an interview that the study “establishes the feasibility and acceptability of oocyte harvest and preservation in a population of patients with active ongoing symptoms from SCD. It also indicates their interest in pursuing fertility preservation in the setting of frequent crises and the potential for management of ensuing complications.”

Mishkin, who didn’t take part in the research, highlighted the finding that half the patients got access to FP via public insurance or research funding. “Even in this population where most women had multiple complications in the year prior to FP, and even among patients who needed multiple retrievals, these patients wanted to go through that risk to preserve their fertility,” Mishkin said. “This is an important finding given the very limited access many individuals have to FP due to its high cost and limited insurance coverage, which is also largely state-dependent.”

There’s another factor to consider regarding SCD and FP: The potential danger of pregnancy.

Corresponding author Pecker noted that “pregnancy is high risk for people with sickle cell disease. There are very high rates of severe maternal mortality and morbidity even in high-income countries. However, some of this is modifiable with routine use of chronic transfusions during pregnancy and with high-quality and integrated expert SCD and expert maternal fetal medicine care during pregnancy.”

The National Institutes of Health supported the research. Pecker reported receiving research funding from Alexion, Novartis, and Aummune and consulting for Novo Nordisk. Other authors reported no disclosures. Su and Mishkin reported no disclosures.

 

A version of this article appeared on Medscape.com.

SAN DIEGO — Significant complications were common in female patients with sickle cell disease (SCD) who underwent fertility preservation (FP) procedures, and 13% required multiple retrieval cycles, a five-center retrospective study found.

Of 46 patients with SCD, complications occurred in 25 of 55 controlled ovarian hyperstimulation cycles, including 29 vaso-occlusive episodes (VOEs), researchers reported at the American Society of Hematology (ASH) 2024 Annual Meeting.

Of 21 post-retrieval VOEs, 19 required emergency department care or hospitalization.

“Baseline sickle cell disease severity is most likely associated with a patient’s risk of complications from an egg retrieval cycle,” study co-author Sarah Cromack, MD, a reproductive endocrinology and infertility fellow at Northwestern University, Chicago, said in an interview.

“Both hematologists and reproductive endocrinologists can use this information to plan ahead and anticipate possible issues, check blood counts prior to and after egg retrieval to see if transfusion is needed, and plan close follow-up during stimulation and immediately after egg retrieval to evaluate and treat pain.”

 

SCD Accelerates Decline in Ovarian Reserve

Pediatric hematologist Lydia H. Pecker, MD, MS, of Johns Hopkins University School of Medicine, Baltimore, the study’s corresponding author, said in an interview that SCD is “a disease of accelerated aging” that leads to accelerated decline in ovarian reserve. “The common indication for fertility preservation in SCD is before bone marrow transplant or gene therapy,” she said, although FP can also be offered to other patients with SCD.

According to Cromack, researchers launched the study to expand information about SCD and FP in light of sparse data about outcomes.

All the 46 patients had hemoglobin SS (HbSS, 93%) and HbSβ0-thalassemia (7%) and a median age of 23.7 (18-28) years. Almost all (44 patients) underwent FP prior to curative treatments, and all had at least one SCD-related complication, mainly cerebrovascular disease (16), acute chest syndrome (23), and more than two VOEs per year (31).

Median anti-Mullerian hormone (AMH) level (2.1 ng/mL), a measurement of ovarian reserve, was lower than the expected level of 2.8-3.4 ng/mL among women in the age range of the patients, the researchers reported. “This is consistent with previous studies showing lower AMH for age in women with sickle cell disease,” Pecker said.

 

Complications in 45% of Retrieval Cycles

“In terms of success of oocyte cryopreservation, the median number of mature eggs frozen was 11,” said co-author and reproductive endocrinologist Jessica Walter, MD, of Northwestern University, in an interview. “Given the average age of 24 years in the cohort, this would give each patient about a 70% estimated probability of at least one live birth from their cohort of frozen eggs. Thus, patients hoping for more than one child may want to consider more than one cycle of egg freezing.”

The rate of complications was “fairly high” at 45% of all cycles, Walter said. “These were mostly complications from underlying sickle cell disease, including unplanned transfusions and admissions for vaso-occlusive crises. Surprisingly, there were very few cases of ovarian hyperstimulation syndrome in this young patient group, which may be due to a combination of underlying vascular disease, lower peak estradiol levels, and slightly less eggs retrieved then would be expected compared to an age-matched healthy controls.”

Any FP complication was associated with more than three VOEs in the year before controlled ovarian hyperstimulation (mean of three VOEs per patient without complications vs six per patient with complications; P = .036).

 

Higher Than Normal Need for Multiple Cycles

Reproductive endocrinologist H. Irene Su, MD, professor and co-director of the Center for OB/GYN Research Innovations at Moores Cancer Center, University of California San Diego, praised the study as “an important report” in an interview.

Su, who wasn’t involved in the research, said the percentage of patients requiring more than one cycle due to cancellation or low oocyte yield — 13% — is “higher than expected, given the young age of this cohort.”

This could reflect the hypothesis that “sickle cell crises and hypoxia adversely affect the finite number of oocytes in the ovary,” she said.

As for the study findings regarding complications, she said the rate “is very high compared to the general infertility or fertility preservation population. It would be good to learn predictors of these outcomes so that fertility and hematology clinicians can work together to stratify risk and supportive services around FP cycles. It would also be good to know if the post-retrieval VOE were unexpected given the patient’s disease activity prior to FP.”

 

Message: FP in SCD Is Feasible, Acceptable

A.D. Mishkin, MD, MPH, associate professor of psychiatry and liaison to the Blood and Marrow Transplantation Program at NewYork–Presbyterian/Columbia University Irving Medical Center, New York City, said in an interview that the study “establishes the feasibility and acceptability of oocyte harvest and preservation in a population of patients with active ongoing symptoms from SCD. It also indicates their interest in pursuing fertility preservation in the setting of frequent crises and the potential for management of ensuing complications.”

Mishkin, who didn’t take part in the research, highlighted the finding that half the patients got access to FP via public insurance or research funding. “Even in this population where most women had multiple complications in the year prior to FP, and even among patients who needed multiple retrievals, these patients wanted to go through that risk to preserve their fertility,” Mishkin said. “This is an important finding given the very limited access many individuals have to FP due to its high cost and limited insurance coverage, which is also largely state-dependent.”

There’s another factor to consider regarding SCD and FP: The potential danger of pregnancy.

Corresponding author Pecker noted that “pregnancy is high risk for people with sickle cell disease. There are very high rates of severe maternal mortality and morbidity even in high-income countries. However, some of this is modifiable with routine use of chronic transfusions during pregnancy and with high-quality and integrated expert SCD and expert maternal fetal medicine care during pregnancy.”

The National Institutes of Health supported the research. Pecker reported receiving research funding from Alexion, Novartis, and Aummune and consulting for Novo Nordisk. Other authors reported no disclosures. Su and Mishkin reported no disclosures.

 

A version of this article appeared on Medscape.com.

SAN DIEGO — Significant complications were common in female patients with sickle cell disease (SCD) who underwent fertility preservation (FP) procedures, and 13% required multiple retrieval cycles, a five-center retrospective study found.

Of 46 patients with SCD, complications occurred in 25 of 55 controlled ovarian hyperstimulation cycles, including 29 vaso-occlusive episodes (VOEs), researchers reported at the American Society of Hematology (ASH) 2024 Annual Meeting.

Of 21 post-retrieval VOEs, 19 required emergency department care or hospitalization.

“Baseline sickle cell disease severity is most likely associated with a patient’s risk of complications from an egg retrieval cycle,” study co-author Sarah Cromack, MD, a reproductive endocrinology and infertility fellow at Northwestern University, Chicago, said in an interview.

“Both hematologists and reproductive endocrinologists can use this information to plan ahead and anticipate possible issues, check blood counts prior to and after egg retrieval to see if transfusion is needed, and plan close follow-up during stimulation and immediately after egg retrieval to evaluate and treat pain.”

 

SCD Accelerates Decline in Ovarian Reserve

Pediatric hematologist Lydia H. Pecker, MD, MS, of Johns Hopkins University School of Medicine, Baltimore, the study’s corresponding author, said in an interview that SCD is “a disease of accelerated aging” that leads to accelerated decline in ovarian reserve. “The common indication for fertility preservation in SCD is before bone marrow transplant or gene therapy,” she said, although FP can also be offered to other patients with SCD.

According to Cromack, researchers launched the study to expand information about SCD and FP in light of sparse data about outcomes.

All the 46 patients had hemoglobin SS (HbSS, 93%) and HbSβ0-thalassemia (7%) and a median age of 23.7 (18-28) years. Almost all (44 patients) underwent FP prior to curative treatments, and all had at least one SCD-related complication, mainly cerebrovascular disease (16), acute chest syndrome (23), and more than two VOEs per year (31).

Median anti-Mullerian hormone (AMH) level (2.1 ng/mL), a measurement of ovarian reserve, was lower than the expected level of 2.8-3.4 ng/mL among women in the age range of the patients, the researchers reported. “This is consistent with previous studies showing lower AMH for age in women with sickle cell disease,” Pecker said.

 

Complications in 45% of Retrieval Cycles

“In terms of success of oocyte cryopreservation, the median number of mature eggs frozen was 11,” said co-author and reproductive endocrinologist Jessica Walter, MD, of Northwestern University, in an interview. “Given the average age of 24 years in the cohort, this would give each patient about a 70% estimated probability of at least one live birth from their cohort of frozen eggs. Thus, patients hoping for more than one child may want to consider more than one cycle of egg freezing.”

The rate of complications was “fairly high” at 45% of all cycles, Walter said. “These were mostly complications from underlying sickle cell disease, including unplanned transfusions and admissions for vaso-occlusive crises. Surprisingly, there were very few cases of ovarian hyperstimulation syndrome in this young patient group, which may be due to a combination of underlying vascular disease, lower peak estradiol levels, and slightly less eggs retrieved then would be expected compared to an age-matched healthy controls.”

Any FP complication was associated with more than three VOEs in the year before controlled ovarian hyperstimulation (mean of three VOEs per patient without complications vs six per patient with complications; P = .036).

 

Higher Than Normal Need for Multiple Cycles

Reproductive endocrinologist H. Irene Su, MD, professor and co-director of the Center for OB/GYN Research Innovations at Moores Cancer Center, University of California San Diego, praised the study as “an important report” in an interview.

Su, who wasn’t involved in the research, said the percentage of patients requiring more than one cycle due to cancellation or low oocyte yield — 13% — is “higher than expected, given the young age of this cohort.”

This could reflect the hypothesis that “sickle cell crises and hypoxia adversely affect the finite number of oocytes in the ovary,” she said.

As for the study findings regarding complications, she said the rate “is very high compared to the general infertility or fertility preservation population. It would be good to learn predictors of these outcomes so that fertility and hematology clinicians can work together to stratify risk and supportive services around FP cycles. It would also be good to know if the post-retrieval VOE were unexpected given the patient’s disease activity prior to FP.”

 

Message: FP in SCD Is Feasible, Acceptable

A.D. Mishkin, MD, MPH, associate professor of psychiatry and liaison to the Blood and Marrow Transplantation Program at NewYork–Presbyterian/Columbia University Irving Medical Center, New York City, said in an interview that the study “establishes the feasibility and acceptability of oocyte harvest and preservation in a population of patients with active ongoing symptoms from SCD. It also indicates their interest in pursuing fertility preservation in the setting of frequent crises and the potential for management of ensuing complications.”

Mishkin, who didn’t take part in the research, highlighted the finding that half the patients got access to FP via public insurance or research funding. “Even in this population where most women had multiple complications in the year prior to FP, and even among patients who needed multiple retrievals, these patients wanted to go through that risk to preserve their fertility,” Mishkin said. “This is an important finding given the very limited access many individuals have to FP due to its high cost and limited insurance coverage, which is also largely state-dependent.”

There’s another factor to consider regarding SCD and FP: The potential danger of pregnancy.

Corresponding author Pecker noted that “pregnancy is high risk for people with sickle cell disease. There are very high rates of severe maternal mortality and morbidity even in high-income countries. However, some of this is modifiable with routine use of chronic transfusions during pregnancy and with high-quality and integrated expert SCD and expert maternal fetal medicine care during pregnancy.”

The National Institutes of Health supported the research. Pecker reported receiving research funding from Alexion, Novartis, and Aummune and consulting for Novo Nordisk. Other authors reported no disclosures. Su and Mishkin reported no disclosures.

 

A version of this article appeared on Medscape.com.

For younger, fit patients with mantle cell lymphoma (MCL), adding the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib to standard induction therapy with bendamustine/rituximab followed by cytarabine/rituximab adds toxicity without improving efficacy, results of the phase 2 ECOG-ACRIN EA4181 trial indicate.

However, treating patients with bendamustine/rituximab plus acalabrutinib might be preferred to either option with cytarabine.

Although the results showed that the bendamustine/rituximab plus acalabrutinib regimen was not superior to standard induction therapy with or without acalabrutinib, it was the least toxic option. 

Standard induction therapy can be still be considered the standard for this patient population, but eliminating cytarabine represents “an appealing option to avoid high-dose cytarabine,” said study investigator Nina Wagner-Johnston, MD, from Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital, Baltimore, Maryland, during a presentation of the findings at the American Society of Hematology 2024 annual meeting. 

The bendamustine/rituximab plus acalabrutinib regimen, where acalabrutinib replaced high-dose cytarabine, is “the most intriguing arm of the study,” Marcus Messmer, MD, with the Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, said in an interview. 

“The results suggest that bendamustine/rituximab plus acalabrutinib may be equivalent in efficacy to [standard induction] with less toxicity,” said Messmer, who was not involved in the study. 

Unfortunately, the study was not designed to show noninferiority of bendamustine/rituximab plus acalabrutinib compared to standard induction therapy, and the bendamustine/rituximab plus acalabrutinib arm was stopped early because of a lack of a superiority signal, Messmer added.

 

Inside the Findings

MCL is a rare and aggressive B-cell lymphoma that poses unique treatment challenges, particularly in younger patients, for whom the treatment “landscape is shifting rapidly,” Wagner-Johnston explained.

Wagner-Johnston noted that the optimal induction regimen for fit, younger patients with MCL is unclear, although the mainstay of treatment is intensive chemoimmunotherapy with cytarabine.

The standard bendamustine/rituximab followed by cytarabine/rituximab induction regimen is associated with high complete remission and undetectable measurable residual disease, with evidence of improved progression-free survival, she noted. 

“And we know that BTK inhibitors, in combination with chemoimmunotherapy, are highly effective in MCL and that achieving molecular remission or undetectable measurable residual disease is an independent predictor of long-term outcomes in patients. All of these features were key when designing ECOG-ACRIN EA 4181,” Wagner-Johnston told attendees. 

The study enrolled 369 patients, 18-70 years old, with untreated MCL, ECOG performance score 0-2, and adequate organ and marrow function. Study participants were randomized 1:1:1 to the standard induction control arm or to one of two experimental arms. These included the control arm of induction therapy with three cycles of bendamustine/rituximab followed by three cycles of cytarabine/rituximab, the standard induction plus acalabrutinib across both cycles, or six cycles of bendamustine/rituximab with acalabrutinib.

In the standard induction plus acalabrutinib arm, acalabrutinib was dosed continuously at 100 mg twice daily during the initial cycles, and during weeks 1 and 3 of the latter cycles.

The primary analysis focused on 260 patients with an end-of-treatment sample sent for measurable residual disease testing. Roughly 90% of patients completed study treatment, with no differences between treatment arms. 

The primary outcome was a composite of PET/CT complete molecular remission and peripheral blood undetectable measurable residual disease. In the control arm, 82% of patients achieved the primary outcome, as did 82% of patients in the standard induction plus acalabrutinib arm and 78% in the bendamustine/rituximab plus acalabrutinib arm. 

“Notably, neither of the experimental arms were superior to the standard-of-care arm across the board,” Wagner-Johnston said. Overall response rates were “quite high,” with complete response rates of more than 90%, with no differences between the arms. 

Similarly, no significant difference was seen in progression-free survival or overall survival between treatment arms. At a medium follow up of roughly 28 months, the 12-month progression-free survival rate was 90%-92% across the three groups.

The team also evaluated progression-free survival by measurable residual disease status, regardless of whether patients completed protocol therapy. “Not surprisingly,” said Wagner-Johnston, progression-free survival was superior for those with undetectable measurable residual disease, compared with those with detectable levels — but again there was no differences between treatment arms. 

Grades 3-5 treatment-related adverse events occurred in at least 5% of patients and were mostly hematologic. 

The bendamustine/rituximab plus acalabrutinib was associated with significantly less hematologic toxicity, with a febrile neutropenia rate of 4.0% vs 8.9% in the standard induction arm and 9.3% in the standard induction plus acalabrutinib arm. 

Grades 3-5 treatment-related anemia rates were much lower in the bendamustine/rituximab plus acalabrutinib arm (3.0% vs 18.5% for standard induction and 24.8% for standard plus cytarabine). Similarly, the bendamustine/rituximab plus acalabrutinib arm had lower rates of treatment-related grade 3 or higher thrombocytopenia (6.0% vs 44.4% and 51.2%, respectively). 

Across all three treatment groups, rates of neurotoxicity, renal toxicity, bleeding/hemorrhage, and cardiac toxicity were low.

Treatment discontinuations due to adverse events were also low (7%) across the arms, with five treatment-related deaths reported. 

“Standard high-dose cytarabine requires inpatient administration and carries risk of neurologic and hematologic toxicity, making it particularly difficult to give in a community setting,” Marcus said in an interview. “This study, along with updated results from the TRIANGLE study, suggests that we are moving away from high-dose cytotoxic therapy and toward targeted therapy in frontline management of mantle cell lymphoma.”

The study was supported by the National Cancer Institute. Wagner-Johnston has received research founding from Genentech, Merck, and AstraZenecca and consults for Beigene. Marcus had no relevant disclosures.

A version of this article appeared on Medscape.com.

For younger, fit patients with mantle cell lymphoma (MCL), adding the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib to standard induction therapy with bendamustine/rituximab followed by cytarabine/rituximab adds toxicity without improving efficacy, results of the phase 2 ECOG-ACRIN EA4181 trial indicate.

However, treating patients with bendamustine/rituximab plus acalabrutinib might be preferred to either option with cytarabine.

Although the results showed that the bendamustine/rituximab plus acalabrutinib regimen was not superior to standard induction therapy with or without acalabrutinib, it was the least toxic option. 

Standard induction therapy can be still be considered the standard for this patient population, but eliminating cytarabine represents “an appealing option to avoid high-dose cytarabine,” said study investigator Nina Wagner-Johnston, MD, from Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital, Baltimore, Maryland, during a presentation of the findings at the American Society of Hematology 2024 annual meeting. 

The bendamustine/rituximab plus acalabrutinib regimen, where acalabrutinib replaced high-dose cytarabine, is “the most intriguing arm of the study,” Marcus Messmer, MD, with the Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, said in an interview. 

“The results suggest that bendamustine/rituximab plus acalabrutinib may be equivalent in efficacy to [standard induction] with less toxicity,” said Messmer, who was not involved in the study. 

Unfortunately, the study was not designed to show noninferiority of bendamustine/rituximab plus acalabrutinib compared to standard induction therapy, and the bendamustine/rituximab plus acalabrutinib arm was stopped early because of a lack of a superiority signal, Messmer added.

 

Inside the Findings

MCL is a rare and aggressive B-cell lymphoma that poses unique treatment challenges, particularly in younger patients, for whom the treatment “landscape is shifting rapidly,” Wagner-Johnston explained.

Wagner-Johnston noted that the optimal induction regimen for fit, younger patients with MCL is unclear, although the mainstay of treatment is intensive chemoimmunotherapy with cytarabine.

The standard bendamustine/rituximab followed by cytarabine/rituximab induction regimen is associated with high complete remission and undetectable measurable residual disease, with evidence of improved progression-free survival, she noted. 

“And we know that BTK inhibitors, in combination with chemoimmunotherapy, are highly effective in MCL and that achieving molecular remission or undetectable measurable residual disease is an independent predictor of long-term outcomes in patients. All of these features were key when designing ECOG-ACRIN EA 4181,” Wagner-Johnston told attendees. 

The study enrolled 369 patients, 18-70 years old, with untreated MCL, ECOG performance score 0-2, and adequate organ and marrow function. Study participants were randomized 1:1:1 to the standard induction control arm or to one of two experimental arms. These included the control arm of induction therapy with three cycles of bendamustine/rituximab followed by three cycles of cytarabine/rituximab, the standard induction plus acalabrutinib across both cycles, or six cycles of bendamustine/rituximab with acalabrutinib.

In the standard induction plus acalabrutinib arm, acalabrutinib was dosed continuously at 100 mg twice daily during the initial cycles, and during weeks 1 and 3 of the latter cycles.

The primary analysis focused on 260 patients with an end-of-treatment sample sent for measurable residual disease testing. Roughly 90% of patients completed study treatment, with no differences between treatment arms. 

The primary outcome was a composite of PET/CT complete molecular remission and peripheral blood undetectable measurable residual disease. In the control arm, 82% of patients achieved the primary outcome, as did 82% of patients in the standard induction plus acalabrutinib arm and 78% in the bendamustine/rituximab plus acalabrutinib arm. 

“Notably, neither of the experimental arms were superior to the standard-of-care arm across the board,” Wagner-Johnston said. Overall response rates were “quite high,” with complete response rates of more than 90%, with no differences between the arms. 

Similarly, no significant difference was seen in progression-free survival or overall survival between treatment arms. At a medium follow up of roughly 28 months, the 12-month progression-free survival rate was 90%-92% across the three groups.

The team also evaluated progression-free survival by measurable residual disease status, regardless of whether patients completed protocol therapy. “Not surprisingly,” said Wagner-Johnston, progression-free survival was superior for those with undetectable measurable residual disease, compared with those with detectable levels — but again there was no differences between treatment arms. 

Grades 3-5 treatment-related adverse events occurred in at least 5% of patients and were mostly hematologic. 

The bendamustine/rituximab plus acalabrutinib was associated with significantly less hematologic toxicity, with a febrile neutropenia rate of 4.0% vs 8.9% in the standard induction arm and 9.3% in the standard induction plus acalabrutinib arm. 

Grades 3-5 treatment-related anemia rates were much lower in the bendamustine/rituximab plus acalabrutinib arm (3.0% vs 18.5% for standard induction and 24.8% for standard plus cytarabine). Similarly, the bendamustine/rituximab plus acalabrutinib arm had lower rates of treatment-related grade 3 or higher thrombocytopenia (6.0% vs 44.4% and 51.2%, respectively). 

Across all three treatment groups, rates of neurotoxicity, renal toxicity, bleeding/hemorrhage, and cardiac toxicity were low.

Treatment discontinuations due to adverse events were also low (7%) across the arms, with five treatment-related deaths reported. 

“Standard high-dose cytarabine requires inpatient administration and carries risk of neurologic and hematologic toxicity, making it particularly difficult to give in a community setting,” Marcus said in an interview. “This study, along with updated results from the TRIANGLE study, suggests that we are moving away from high-dose cytotoxic therapy and toward targeted therapy in frontline management of mantle cell lymphoma.”

The study was supported by the National Cancer Institute. Wagner-Johnston has received research founding from Genentech, Merck, and AstraZenecca and consults for Beigene. Marcus had no relevant disclosures.

A version of this article appeared on Medscape.com.

For younger, fit patients with mantle cell lymphoma (MCL), adding the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib to standard induction therapy with bendamustine/rituximab followed by cytarabine/rituximab adds toxicity without improving efficacy, results of the phase 2 ECOG-ACRIN EA4181 trial indicate.

However, treating patients with bendamustine/rituximab plus acalabrutinib might be preferred to either option with cytarabine.

Although the results showed that the bendamustine/rituximab plus acalabrutinib regimen was not superior to standard induction therapy with or without acalabrutinib, it was the least toxic option. 

Standard induction therapy can be still be considered the standard for this patient population, but eliminating cytarabine represents “an appealing option to avoid high-dose cytarabine,” said study investigator Nina Wagner-Johnston, MD, from Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital, Baltimore, Maryland, during a presentation of the findings at the American Society of Hematology 2024 annual meeting. 

The bendamustine/rituximab plus acalabrutinib regimen, where acalabrutinib replaced high-dose cytarabine, is “the most intriguing arm of the study,” Marcus Messmer, MD, with the Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, said in an interview. 

“The results suggest that bendamustine/rituximab plus acalabrutinib may be equivalent in efficacy to [standard induction] with less toxicity,” said Messmer, who was not involved in the study. 

Unfortunately, the study was not designed to show noninferiority of bendamustine/rituximab plus acalabrutinib compared to standard induction therapy, and the bendamustine/rituximab plus acalabrutinib arm was stopped early because of a lack of a superiority signal, Messmer added.

 

Inside the Findings

MCL is a rare and aggressive B-cell lymphoma that poses unique treatment challenges, particularly in younger patients, for whom the treatment “landscape is shifting rapidly,” Wagner-Johnston explained.

Wagner-Johnston noted that the optimal induction regimen for fit, younger patients with MCL is unclear, although the mainstay of treatment is intensive chemoimmunotherapy with cytarabine.

The standard bendamustine/rituximab followed by cytarabine/rituximab induction regimen is associated with high complete remission and undetectable measurable residual disease, with evidence of improved progression-free survival, she noted. 

“And we know that BTK inhibitors, in combination with chemoimmunotherapy, are highly effective in MCL and that achieving molecular remission or undetectable measurable residual disease is an independent predictor of long-term outcomes in patients. All of these features were key when designing ECOG-ACRIN EA 4181,” Wagner-Johnston told attendees. 

The study enrolled 369 patients, 18-70 years old, with untreated MCL, ECOG performance score 0-2, and adequate organ and marrow function. Study participants were randomized 1:1:1 to the standard induction control arm or to one of two experimental arms. These included the control arm of induction therapy with three cycles of bendamustine/rituximab followed by three cycles of cytarabine/rituximab, the standard induction plus acalabrutinib across both cycles, or six cycles of bendamustine/rituximab with acalabrutinib.

In the standard induction plus acalabrutinib arm, acalabrutinib was dosed continuously at 100 mg twice daily during the initial cycles, and during weeks 1 and 3 of the latter cycles.

The primary analysis focused on 260 patients with an end-of-treatment sample sent for measurable residual disease testing. Roughly 90% of patients completed study treatment, with no differences between treatment arms. 

The primary outcome was a composite of PET/CT complete molecular remission and peripheral blood undetectable measurable residual disease. In the control arm, 82% of patients achieved the primary outcome, as did 82% of patients in the standard induction plus acalabrutinib arm and 78% in the bendamustine/rituximab plus acalabrutinib arm. 

“Notably, neither of the experimental arms were superior to the standard-of-care arm across the board,” Wagner-Johnston said. Overall response rates were “quite high,” with complete response rates of more than 90%, with no differences between the arms. 

Similarly, no significant difference was seen in progression-free survival or overall survival between treatment arms. At a medium follow up of roughly 28 months, the 12-month progression-free survival rate was 90%-92% across the three groups.

The team also evaluated progression-free survival by measurable residual disease status, regardless of whether patients completed protocol therapy. “Not surprisingly,” said Wagner-Johnston, progression-free survival was superior for those with undetectable measurable residual disease, compared with those with detectable levels — but again there was no differences between treatment arms. 

Grades 3-5 treatment-related adverse events occurred in at least 5% of patients and were mostly hematologic. 

The bendamustine/rituximab plus acalabrutinib was associated with significantly less hematologic toxicity, with a febrile neutropenia rate of 4.0% vs 8.9% in the standard induction arm and 9.3% in the standard induction plus acalabrutinib arm. 

Grades 3-5 treatment-related anemia rates were much lower in the bendamustine/rituximab plus acalabrutinib arm (3.0% vs 18.5% for standard induction and 24.8% for standard plus cytarabine). Similarly, the bendamustine/rituximab plus acalabrutinib arm had lower rates of treatment-related grade 3 or higher thrombocytopenia (6.0% vs 44.4% and 51.2%, respectively). 

Across all three treatment groups, rates of neurotoxicity, renal toxicity, bleeding/hemorrhage, and cardiac toxicity were low.

Treatment discontinuations due to adverse events were also low (7%) across the arms, with five treatment-related deaths reported. 

“Standard high-dose cytarabine requires inpatient administration and carries risk of neurologic and hematologic toxicity, making it particularly difficult to give in a community setting,” Marcus said in an interview. “This study, along with updated results from the TRIANGLE study, suggests that we are moving away from high-dose cytotoxic therapy and toward targeted therapy in frontline management of mantle cell lymphoma.”

The study was supported by the National Cancer Institute. Wagner-Johnston has received research founding from Genentech, Merck, and AstraZenecca and consults for Beigene. Marcus had no relevant disclosures.

A version of this article appeared on Medscape.com.

Patients with diffuse large B-cell lymphoma (DLBCL) continue to show superior progression-free survival at 5 years with first-line pola-R-CHP, compared with the R-CHOP regimen, according to updated results of the phase 3 POLARIX study.

These findings “confirm pola-R-CHP as the standard of care for patients with previously untreated intermediate- or high-risk DLBCL,” said lead investigator Gilles Salles, MD, PhD, who presented the extended results at the American Society of Hematology (ASH) 2024 Annual Meeting.

Pola-R-CHP is a modified version of the R-CHOP regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in which vincristine is replaced with polatuzumab vedotin. The modified regimen was approved by the Food and Drug Administration in April 2023 on the basis of 2-year results from the same study.

In POLARIX, researchers randomized 879 previously untreated adult patients with CD20-positive DLBCL (median age, 66 years) to six to eight 21-day cycles of treatment with either pola-R-CHP or R-CHOP. The primary endpoint was progression-free survival, and secondary endpoints included complete remission and overall survival.

The initial 2-year results — progression-free survival of 76.7% for pola-R-CHP vs 70.2% for R-CHOP — “were the first in 20 years” showing benefits for patients with DLBCL, said Salles, from Memorial Sloan Kettering Cancer Center, New York City.

In the current analysis, there were 879 patients in the global intention-to-treat population — 440 who received pola-R-CHP and 439 who received R-CHOP — and 873 in the safety analysis.

At the 5-year follow-up, Salles and colleagues observed a sustained and significant progression-free survival benefit in patients treated with pola-R-CHP, compared with those who received R-CHOP (64.9% vs 59.1%; hazard ratio [HR], 0.77).

Patients receiving the modified regimen also demonstrated significantly higher rates of complete remission at 5 years (71.8% vs 66.5%; HR, 0.75). These data tell us that for patients who reach complete remission at the end of treatment, the vast majority are still in remission at 5 years, said Salles.

For patients who did progress, those treated with pola-R-CHP had fewer subsequent therapies than those treated with R-CHOP. This included radiotherapy (9.5% vs 14.1%), systemic therapy (20.0% vs 28.2%), platinum-based therapy (9.8% vs 15.5%), stem cell transplant (5.0% vs 8.4%), chimeric antigen receptor T-cell therapy (2.3% vs 4.1%), and bispecifics (1.4% vs 2.1%).

The 5-year overall survival, a secondary endpoint, was numerically better but not significantly so among patients treated with pola-R-CHP (82.3% vs 79.5%; HR, 0.85).

In a competing risk analysis, the cumulative incidence of lymphoma-related deaths at 5 years was 9.1% with pola-R-CHP vs 12.2% with R-CHOP. The probability of non-lymphoma–related deaths, including death due to study treatment, was similar between the two groups at 5 years — 8.56% with pola-R-CHP vs 8.93% with R-CHOP.

An exploratory analysis of progression-free survival and overall survival in subgroups of the patient population, including those with high-risk disease, showed a trend in favor of pola-R-CHP in almost all cases, but Salles warned that the analysis was underpowered.

“I think that interpreting this data to decide the care of the patient should be done very cautiously,” he said.

The researchers did not observe any new safety signals, with pola-R-CHP continuing to show a favorable benefit-risk profile. Looking at adverse events of all grades, Salles noted slightly less peripheral neuropathy with pola-R-CHP (50.3% vs 52.4%), slightly more infection (47.9% vs 44.0%), as well as a favorable trend for pola-R-CHP regarding cardiac arrhythmia (3.6% vs 5.2%) and carcinogenicity (1.0% vs 2.4%), and “very slight and tiny differences” in neutropenia (48.5% vs 45.8%), anemia (33.3% vs 30.1%), and thrombocytopenia (18.0% vs 17.3%).

While the researchers concluded that the study findings confirm pola-R-CHP as the standard of care for patients with previously untreated intermediate- or high-risk DLBCL, Ajay Major, MD, had some reservations.

The results confirm “a small but significant benefit” in progression-free survival and no significant difference in overall survival, but there is some question as to whether pola-R-CHP is appropriate for all-comers with intermediate- or high-risk DLBCL, noted Major, a lymphoma specialist and assistant professor of medicine at the University of Colorado School of Medicine, Aurora, who was not involved in this analysis.

“The subgroup analysis in POLARIX for efficacy of pola-R-CHP based on cell of origin is not adequately powered, and further dedicated on this question studies are needed,” Major said in an interview.

One study presented at the meeting by Major’s group concluded that cell of origin is a strong predictor of the activity of pola-containing therapy in patients with relapsed/refractory large B-cell lymphoma, while another analysis of POLARIX showed progression-free survival and overall survival benefits of pola-R-CHP over R-CHOP in patients with the activated B-cell subtype of DLBCL but not those with the germinal center B-cell subtype, Major noted.

“I think many oncologists will extrapolate from these other data sources and preferentially use pola-R-CHP in patients with activated B-cell or non-germinal center DLBCL,” he predicted.

The study was funded by F. Hoffmann–La Roche/Genentech. Salles reported disclosures with the following companies: BeiGene (consultancy), AbbVie (consultancy, research funding), Genentech/Roche (consultancy, research funding), Incyte (consultancy), and BMS/Celgene (consultancy), among others. Major reported conflicts of interest with Roche/Genentech (consultancy), GSK (research funding), and Incyte (research funding).

A version of this article appeared on Medscape.com.

Patients with diffuse large B-cell lymphoma (DLBCL) continue to show superior progression-free survival at 5 years with first-line pola-R-CHP, compared with the R-CHOP regimen, according to updated results of the phase 3 POLARIX study.

These findings “confirm pola-R-CHP as the standard of care for patients with previously untreated intermediate- or high-risk DLBCL,” said lead investigator Gilles Salles, MD, PhD, who presented the extended results at the American Society of Hematology (ASH) 2024 Annual Meeting.

Pola-R-CHP is a modified version of the R-CHOP regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in which vincristine is replaced with polatuzumab vedotin. The modified regimen was approved by the Food and Drug Administration in April 2023 on the basis of 2-year results from the same study.

In POLARIX, researchers randomized 879 previously untreated adult patients with CD20-positive DLBCL (median age, 66 years) to six to eight 21-day cycles of treatment with either pola-R-CHP or R-CHOP. The primary endpoint was progression-free survival, and secondary endpoints included complete remission and overall survival.

The initial 2-year results — progression-free survival of 76.7% for pola-R-CHP vs 70.2% for R-CHOP — “were the first in 20 years” showing benefits for patients with DLBCL, said Salles, from Memorial Sloan Kettering Cancer Center, New York City.

In the current analysis, there were 879 patients in the global intention-to-treat population — 440 who received pola-R-CHP and 439 who received R-CHOP — and 873 in the safety analysis.

At the 5-year follow-up, Salles and colleagues observed a sustained and significant progression-free survival benefit in patients treated with pola-R-CHP, compared with those who received R-CHOP (64.9% vs 59.1%; hazard ratio [HR], 0.77).

Patients receiving the modified regimen also demonstrated significantly higher rates of complete remission at 5 years (71.8% vs 66.5%; HR, 0.75). These data tell us that for patients who reach complete remission at the end of treatment, the vast majority are still in remission at 5 years, said Salles.

For patients who did progress, those treated with pola-R-CHP had fewer subsequent therapies than those treated with R-CHOP. This included radiotherapy (9.5% vs 14.1%), systemic therapy (20.0% vs 28.2%), platinum-based therapy (9.8% vs 15.5%), stem cell transplant (5.0% vs 8.4%), chimeric antigen receptor T-cell therapy (2.3% vs 4.1%), and bispecifics (1.4% vs 2.1%).

The 5-year overall survival, a secondary endpoint, was numerically better but not significantly so among patients treated with pola-R-CHP (82.3% vs 79.5%; HR, 0.85).

In a competing risk analysis, the cumulative incidence of lymphoma-related deaths at 5 years was 9.1% with pola-R-CHP vs 12.2% with R-CHOP. The probability of non-lymphoma–related deaths, including death due to study treatment, was similar between the two groups at 5 years — 8.56% with pola-R-CHP vs 8.93% with R-CHOP.

An exploratory analysis of progression-free survival and overall survival in subgroups of the patient population, including those with high-risk disease, showed a trend in favor of pola-R-CHP in almost all cases, but Salles warned that the analysis was underpowered.

“I think that interpreting this data to decide the care of the patient should be done very cautiously,” he said.

The researchers did not observe any new safety signals, with pola-R-CHP continuing to show a favorable benefit-risk profile. Looking at adverse events of all grades, Salles noted slightly less peripheral neuropathy with pola-R-CHP (50.3% vs 52.4%), slightly more infection (47.9% vs 44.0%), as well as a favorable trend for pola-R-CHP regarding cardiac arrhythmia (3.6% vs 5.2%) and carcinogenicity (1.0% vs 2.4%), and “very slight and tiny differences” in neutropenia (48.5% vs 45.8%), anemia (33.3% vs 30.1%), and thrombocytopenia (18.0% vs 17.3%).

While the researchers concluded that the study findings confirm pola-R-CHP as the standard of care for patients with previously untreated intermediate- or high-risk DLBCL, Ajay Major, MD, had some reservations.

The results confirm “a small but significant benefit” in progression-free survival and no significant difference in overall survival, but there is some question as to whether pola-R-CHP is appropriate for all-comers with intermediate- or high-risk DLBCL, noted Major, a lymphoma specialist and assistant professor of medicine at the University of Colorado School of Medicine, Aurora, who was not involved in this analysis.

“The subgroup analysis in POLARIX for efficacy of pola-R-CHP based on cell of origin is not adequately powered, and further dedicated on this question studies are needed,” Major said in an interview.

One study presented at the meeting by Major’s group concluded that cell of origin is a strong predictor of the activity of pola-containing therapy in patients with relapsed/refractory large B-cell lymphoma, while another analysis of POLARIX showed progression-free survival and overall survival benefits of pola-R-CHP over R-CHOP in patients with the activated B-cell subtype of DLBCL but not those with the germinal center B-cell subtype, Major noted.

“I think many oncologists will extrapolate from these other data sources and preferentially use pola-R-CHP in patients with activated B-cell or non-germinal center DLBCL,” he predicted.

The study was funded by F. Hoffmann–La Roche/Genentech. Salles reported disclosures with the following companies: BeiGene (consultancy), AbbVie (consultancy, research funding), Genentech/Roche (consultancy, research funding), Incyte (consultancy), and BMS/Celgene (consultancy), among others. Major reported conflicts of interest with Roche/Genentech (consultancy), GSK (research funding), and Incyte (research funding).

A version of this article appeared on Medscape.com.

Patients with diffuse large B-cell lymphoma (DLBCL) continue to show superior progression-free survival at 5 years with first-line pola-R-CHP, compared with the R-CHOP regimen, according to updated results of the phase 3 POLARIX study.

These findings “confirm pola-R-CHP as the standard of care for patients with previously untreated intermediate- or high-risk DLBCL,” said lead investigator Gilles Salles, MD, PhD, who presented the extended results at the American Society of Hematology (ASH) 2024 Annual Meeting.

Pola-R-CHP is a modified version of the R-CHOP regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in which vincristine is replaced with polatuzumab vedotin. The modified regimen was approved by the Food and Drug Administration in April 2023 on the basis of 2-year results from the same study.

In POLARIX, researchers randomized 879 previously untreated adult patients with CD20-positive DLBCL (median age, 66 years) to six to eight 21-day cycles of treatment with either pola-R-CHP or R-CHOP. The primary endpoint was progression-free survival, and secondary endpoints included complete remission and overall survival.

The initial 2-year results — progression-free survival of 76.7% for pola-R-CHP vs 70.2% for R-CHOP — “were the first in 20 years” showing benefits for patients with DLBCL, said Salles, from Memorial Sloan Kettering Cancer Center, New York City.

In the current analysis, there were 879 patients in the global intention-to-treat population — 440 who received pola-R-CHP and 439 who received R-CHOP — and 873 in the safety analysis.

At the 5-year follow-up, Salles and colleagues observed a sustained and significant progression-free survival benefit in patients treated with pola-R-CHP, compared with those who received R-CHOP (64.9% vs 59.1%; hazard ratio [HR], 0.77).

Patients receiving the modified regimen also demonstrated significantly higher rates of complete remission at 5 years (71.8% vs 66.5%; HR, 0.75). These data tell us that for patients who reach complete remission at the end of treatment, the vast majority are still in remission at 5 years, said Salles.

For patients who did progress, those treated with pola-R-CHP had fewer subsequent therapies than those treated with R-CHOP. This included radiotherapy (9.5% vs 14.1%), systemic therapy (20.0% vs 28.2%), platinum-based therapy (9.8% vs 15.5%), stem cell transplant (5.0% vs 8.4%), chimeric antigen receptor T-cell therapy (2.3% vs 4.1%), and bispecifics (1.4% vs 2.1%).

The 5-year overall survival, a secondary endpoint, was numerically better but not significantly so among patients treated with pola-R-CHP (82.3% vs 79.5%; HR, 0.85).

In a competing risk analysis, the cumulative incidence of lymphoma-related deaths at 5 years was 9.1% with pola-R-CHP vs 12.2% with R-CHOP. The probability of non-lymphoma–related deaths, including death due to study treatment, was similar between the two groups at 5 years — 8.56% with pola-R-CHP vs 8.93% with R-CHOP.

An exploratory analysis of progression-free survival and overall survival in subgroups of the patient population, including those with high-risk disease, showed a trend in favor of pola-R-CHP in almost all cases, but Salles warned that the analysis was underpowered.

“I think that interpreting this data to decide the care of the patient should be done very cautiously,” he said.

The researchers did not observe any new safety signals, with pola-R-CHP continuing to show a favorable benefit-risk profile. Looking at adverse events of all grades, Salles noted slightly less peripheral neuropathy with pola-R-CHP (50.3% vs 52.4%), slightly more infection (47.9% vs 44.0%), as well as a favorable trend for pola-R-CHP regarding cardiac arrhythmia (3.6% vs 5.2%) and carcinogenicity (1.0% vs 2.4%), and “very slight and tiny differences” in neutropenia (48.5% vs 45.8%), anemia (33.3% vs 30.1%), and thrombocytopenia (18.0% vs 17.3%).

While the researchers concluded that the study findings confirm pola-R-CHP as the standard of care for patients with previously untreated intermediate- or high-risk DLBCL, Ajay Major, MD, had some reservations.

The results confirm “a small but significant benefit” in progression-free survival and no significant difference in overall survival, but there is some question as to whether pola-R-CHP is appropriate for all-comers with intermediate- or high-risk DLBCL, noted Major, a lymphoma specialist and assistant professor of medicine at the University of Colorado School of Medicine, Aurora, who was not involved in this analysis.

“The subgroup analysis in POLARIX for efficacy of pola-R-CHP based on cell of origin is not adequately powered, and further dedicated on this question studies are needed,” Major said in an interview.

One study presented at the meeting by Major’s group concluded that cell of origin is a strong predictor of the activity of pola-containing therapy in patients with relapsed/refractory large B-cell lymphoma, while another analysis of POLARIX showed progression-free survival and overall survival benefits of pola-R-CHP over R-CHOP in patients with the activated B-cell subtype of DLBCL but not those with the germinal center B-cell subtype, Major noted.

“I think many oncologists will extrapolate from these other data sources and preferentially use pola-R-CHP in patients with activated B-cell or non-germinal center DLBCL,” he predicted.

The study was funded by F. Hoffmann–La Roche/Genentech. Salles reported disclosures with the following companies: BeiGene (consultancy), AbbVie (consultancy, research funding), Genentech/Roche (consultancy, research funding), Incyte (consultancy), and BMS/Celgene (consultancy), among others. Major reported conflicts of interest with Roche/Genentech (consultancy), GSK (research funding), and Incyte (research funding).

A version of this article appeared on Medscape.com.

LOS ANGELES — A mattress designed to detect seizures in individuals with epilepsy who are lying face down and quickly reposition them onto their side could significantly reduce the risk for sudden unexpected death in epilepsy (SUDEP), says one of the experts involved in its development.

When used along with a seizure detection device, Jong Woo Lee, MD, PhD, associate professor of neurology, Harvard Medical School, and Brigham and Women’s Hospital, both in Boston, Massachusetts, estimates the smart mattress could cut SUDEP by more than 50%.

In addition, early results from an observational study are backing this up, he said.

The findings were presented at the American Epilepsy Society (AES) 78th Annual Meeting 2024.

 

Most SUDEP Cases Found Face Down

SUDEP is the leading cause of death in children with epilepsy and in otherwise healthy adult patients with epilepsy. When his fifth patient died of SUDEP, Lee decided it was time to try to tackle the high mortality rate associated with these unexpected deaths. “I desperately wanted to help, ” he said.

About 70% of SUDEP occurs during sleep, and victims are found face down, or in the prone position, 90% of the time, said Lee.

“Of course, the best way to prevent SUDEP is not to have a seizure, but once you have a seizure and once you’re face down, your risk for death goes up by somewhere between 30 and 100 times,” he explained.

Lee was convinced SUDEP could be prevented by simple interventions that stimulate the patient and turn them over. He noted the incidence of sudden infant death syndrome, “which has similar characteristics” to SUDEP, has been reduced by up to 75% through campaigns that simply advise placing babies on their backs.

“Most of SUDEP happens because your arousal system is knocked out and you just don’t take the breath that you’re supposed to. Just the act of turning people over and vibrating the bed will stimulate them,” he said.

However, it’s crucial that this be done quickly, said Lee. “When you look at patients who died on video and see the EEGs, everybody took their last breath within 3 minutes.”

Because the window of opportunity is so short, “we think that seizure detection devices alone are not going to really be effective because you just can’t get there or react within those 3 minutes.”

There are currently no products that detect the prone position or have the ability to reposition a patient quickly into the recovery sideways position.

Lee and his colleagues developed a smart system that can be embedded in a mattress that detects when someone is having a seizure, determines if that person is face down, and if so, safely stimulates and repositions them.

The mattress is made up of a series of programmable inflatable blocks or “cells” that have pressure, vibration, temperature, and humidity sensors embedded within. “Based on the pressure readings, we can figure out whether the patient is right side up, on their right side, on their left side, or face down,” said Lee.

If the person is face down, he or she can be repositioned within a matter of seconds. “Each of the cells can lift 1000 pounds,” he said. The mattress is “very comfortable,” said Lee, who has tried it out himself.

Eighteen normative control participants have been enrolled for development and training purposes. To date, 10 of these individuals, aged 18-53 years, weighing 100-182 lb, and with a height of 5 ft 2 in to 6 ft 1 in, underwent extensive formal testing on the prototype bed.

Researchers found the mattress responded quickly to different body positions and weights. “We were able to reposition everybody in around 20 seconds,” said Lee.

The overall accuracy of detecting the prone position was 96.8%. There were no cases of a supine or prone position being mistaken for each other.

Researchers are refining the algorithm to improve the accuracy for detecting the prone position and expect to have a completely functional prototype within a few years.

 

Big Step Forward

Commenting on the research, Daniel M. Goldenholz, MD, PhD, assistant professor, Division of Epilepsy, Harvard Beth Israel Deaconess Medical Center, Boston, said the study “is a big step forward in the race to provide an actionable tool to prevent SUDEP.”

The technology “appears to mostly be doing what it’s intended to do, with relatively minor technical errors being made,” he said.

However, it is not clear if this technology can truly save lives, said Goldenholz. “The data we have suggests that lying face down in bed after a seizure is correlated with SUDEP, but that does not mean that if we can simply flip people over, they for sure won’t die.”

Even if the new technology “works perfectly,” it’s still an open question, said Goldenholz. If it does save lives, “this will be a major breakthrough, and one that has been needed for a long time.”

However, even if it does not, he congratulates the team for trying to determine if reducing the prone position can help prevent SUDEP. He would like to see more “high-risk, high-reward” studies in the epilepsy field. “We are in so much need of new innovations.”

He said he was “personally very inspired” by this work. “People are dying from this terrible disease, and this team is building what they hope might save lives.”

The study was funded by the National Institutes of Health. The mattress is being developed by Soterya. Lee reported no equity in Soterya. Goldenholz reported no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

LOS ANGELES — A mattress designed to detect seizures in individuals with epilepsy who are lying face down and quickly reposition them onto their side could significantly reduce the risk for sudden unexpected death in epilepsy (SUDEP), says one of the experts involved in its development.

When used along with a seizure detection device, Jong Woo Lee, MD, PhD, associate professor of neurology, Harvard Medical School, and Brigham and Women’s Hospital, both in Boston, Massachusetts, estimates the smart mattress could cut SUDEP by more than 50%.

In addition, early results from an observational study are backing this up, he said.

The findings were presented at the American Epilepsy Society (AES) 78th Annual Meeting 2024.

 

Most SUDEP Cases Found Face Down

SUDEP is the leading cause of death in children with epilepsy and in otherwise healthy adult patients with epilepsy. When his fifth patient died of SUDEP, Lee decided it was time to try to tackle the high mortality rate associated with these unexpected deaths. “I desperately wanted to help, ” he said.

About 70% of SUDEP occurs during sleep, and victims are found face down, or in the prone position, 90% of the time, said Lee.

“Of course, the best way to prevent SUDEP is not to have a seizure, but once you have a seizure and once you’re face down, your risk for death goes up by somewhere between 30 and 100 times,” he explained.

Lee was convinced SUDEP could be prevented by simple interventions that stimulate the patient and turn them over. He noted the incidence of sudden infant death syndrome, “which has similar characteristics” to SUDEP, has been reduced by up to 75% through campaigns that simply advise placing babies on their backs.

“Most of SUDEP happens because your arousal system is knocked out and you just don’t take the breath that you’re supposed to. Just the act of turning people over and vibrating the bed will stimulate them,” he said.

However, it’s crucial that this be done quickly, said Lee. “When you look at patients who died on video and see the EEGs, everybody took their last breath within 3 minutes.”

Because the window of opportunity is so short, “we think that seizure detection devices alone are not going to really be effective because you just can’t get there or react within those 3 minutes.”

There are currently no products that detect the prone position or have the ability to reposition a patient quickly into the recovery sideways position.

Lee and his colleagues developed a smart system that can be embedded in a mattress that detects when someone is having a seizure, determines if that person is face down, and if so, safely stimulates and repositions them.

The mattress is made up of a series of programmable inflatable blocks or “cells” that have pressure, vibration, temperature, and humidity sensors embedded within. “Based on the pressure readings, we can figure out whether the patient is right side up, on their right side, on their left side, or face down,” said Lee.

If the person is face down, he or she can be repositioned within a matter of seconds. “Each of the cells can lift 1000 pounds,” he said. The mattress is “very comfortable,” said Lee, who has tried it out himself.

Eighteen normative control participants have been enrolled for development and training purposes. To date, 10 of these individuals, aged 18-53 years, weighing 100-182 lb, and with a height of 5 ft 2 in to 6 ft 1 in, underwent extensive formal testing on the prototype bed.

Researchers found the mattress responded quickly to different body positions and weights. “We were able to reposition everybody in around 20 seconds,” said Lee.

The overall accuracy of detecting the prone position was 96.8%. There were no cases of a supine or prone position being mistaken for each other.

Researchers are refining the algorithm to improve the accuracy for detecting the prone position and expect to have a completely functional prototype within a few years.

 

Big Step Forward

Commenting on the research, Daniel M. Goldenholz, MD, PhD, assistant professor, Division of Epilepsy, Harvard Beth Israel Deaconess Medical Center, Boston, said the study “is a big step forward in the race to provide an actionable tool to prevent SUDEP.”

The technology “appears to mostly be doing what it’s intended to do, with relatively minor technical errors being made,” he said.

However, it is not clear if this technology can truly save lives, said Goldenholz. “The data we have suggests that lying face down in bed after a seizure is correlated with SUDEP, but that does not mean that if we can simply flip people over, they for sure won’t die.”

Even if the new technology “works perfectly,” it’s still an open question, said Goldenholz. If it does save lives, “this will be a major breakthrough, and one that has been needed for a long time.”

However, even if it does not, he congratulates the team for trying to determine if reducing the prone position can help prevent SUDEP. He would like to see more “high-risk, high-reward” studies in the epilepsy field. “We are in so much need of new innovations.”

He said he was “personally very inspired” by this work. “People are dying from this terrible disease, and this team is building what they hope might save lives.”

The study was funded by the National Institutes of Health. The mattress is being developed by Soterya. Lee reported no equity in Soterya. Goldenholz reported no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

LOS ANGELES — A mattress designed to detect seizures in individuals with epilepsy who are lying face down and quickly reposition them onto their side could significantly reduce the risk for sudden unexpected death in epilepsy (SUDEP), says one of the experts involved in its development.

When used along with a seizure detection device, Jong Woo Lee, MD, PhD, associate professor of neurology, Harvard Medical School, and Brigham and Women’s Hospital, both in Boston, Massachusetts, estimates the smart mattress could cut SUDEP by more than 50%.

In addition, early results from an observational study are backing this up, he said.

The findings were presented at the American Epilepsy Society (AES) 78th Annual Meeting 2024.

 

Most SUDEP Cases Found Face Down

SUDEP is the leading cause of death in children with epilepsy and in otherwise healthy adult patients with epilepsy. When his fifth patient died of SUDEP, Lee decided it was time to try to tackle the high mortality rate associated with these unexpected deaths. “I desperately wanted to help, ” he said.

About 70% of SUDEP occurs during sleep, and victims are found face down, or in the prone position, 90% of the time, said Lee.

“Of course, the best way to prevent SUDEP is not to have a seizure, but once you have a seizure and once you’re face down, your risk for death goes up by somewhere between 30 and 100 times,” he explained.

Lee was convinced SUDEP could be prevented by simple interventions that stimulate the patient and turn them over. He noted the incidence of sudden infant death syndrome, “which has similar characteristics” to SUDEP, has been reduced by up to 75% through campaigns that simply advise placing babies on their backs.

“Most of SUDEP happens because your arousal system is knocked out and you just don’t take the breath that you’re supposed to. Just the act of turning people over and vibrating the bed will stimulate them,” he said.

However, it’s crucial that this be done quickly, said Lee. “When you look at patients who died on video and see the EEGs, everybody took their last breath within 3 minutes.”

Because the window of opportunity is so short, “we think that seizure detection devices alone are not going to really be effective because you just can’t get there or react within those 3 minutes.”

There are currently no products that detect the prone position or have the ability to reposition a patient quickly into the recovery sideways position.

Lee and his colleagues developed a smart system that can be embedded in a mattress that detects when someone is having a seizure, determines if that person is face down, and if so, safely stimulates and repositions them.

The mattress is made up of a series of programmable inflatable blocks or “cells” that have pressure, vibration, temperature, and humidity sensors embedded within. “Based on the pressure readings, we can figure out whether the patient is right side up, on their right side, on their left side, or face down,” said Lee.

If the person is face down, he or she can be repositioned within a matter of seconds. “Each of the cells can lift 1000 pounds,” he said. The mattress is “very comfortable,” said Lee, who has tried it out himself.

Eighteen normative control participants have been enrolled for development and training purposes. To date, 10 of these individuals, aged 18-53 years, weighing 100-182 lb, and with a height of 5 ft 2 in to 6 ft 1 in, underwent extensive formal testing on the prototype bed.

Researchers found the mattress responded quickly to different body positions and weights. “We were able to reposition everybody in around 20 seconds,” said Lee.

The overall accuracy of detecting the prone position was 96.8%. There were no cases of a supine or prone position being mistaken for each other.

Researchers are refining the algorithm to improve the accuracy for detecting the prone position and expect to have a completely functional prototype within a few years.

 

Big Step Forward

Commenting on the research, Daniel M. Goldenholz, MD, PhD, assistant professor, Division of Epilepsy, Harvard Beth Israel Deaconess Medical Center, Boston, said the study “is a big step forward in the race to provide an actionable tool to prevent SUDEP.”

The technology “appears to mostly be doing what it’s intended to do, with relatively minor technical errors being made,” he said.

However, it is not clear if this technology can truly save lives, said Goldenholz. “The data we have suggests that lying face down in bed after a seizure is correlated with SUDEP, but that does not mean that if we can simply flip people over, they for sure won’t die.”

Even if the new technology “works perfectly,” it’s still an open question, said Goldenholz. If it does save lives, “this will be a major breakthrough, and one that has been needed for a long time.”

However, even if it does not, he congratulates the team for trying to determine if reducing the prone position can help prevent SUDEP. He would like to see more “high-risk, high-reward” studies in the epilepsy field. “We are in so much need of new innovations.”

He said he was “personally very inspired” by this work. “People are dying from this terrible disease, and this team is building what they hope might save lives.”

The study was funded by the National Institutes of Health. The mattress is being developed by Soterya. Lee reported no equity in Soterya. Goldenholz reported no relevant conflicts of interest.

A version of this article appeared on Medscape.com.