News

The Society for Cardiovascular Angiography and Interventions has issued an updated expert consensus statement to provide clearer guidance on what percutaneous coronary angioplasty cases can be done in outpatient settings such as ambulatory surgery centers (ASCs) and office-based laboratories and which are best left to more traditional settings, such as hospitals with full cardiac support.

PCI has evolved quickly since SCAI issued its last update almost 9 years ago. The updated statement, published online in the Journal of the Society for Cardiovascular Angiography and Interventions, notes that the proportion of same-day PCI discharges has increased from 4.5% in 2009 to 28.6% in 2017.

The statement also notes that the Medicare facility fee for outpatient PCI in an ASC is about 40% less than the hospital fee: $6,111 versus $10,258 for the facility fee for 2022. The Centers for Medicare & Medicaid Services in 2020 extended coverage for PCIs in ASCs.
 

Rationale for update

Writing group chair Cindy Grines, MD, explained the rationale for updating the statement now. “The 2014 SCAI statement was very conservative, recommending only the simplest of cases be done without surgical backup,” Dr. Grines, chief scientific officer at Northside Hospital Cardiovascular Institute in Atlanta, said in an interview.

The statement drew on 12 global studies from 2015 to 2022 that evaluated more than 8 million PCIs at facilities with and without surgery on site. Dr. Grines noted those studies reported complication rates as low as 0.1% in PCI procedures in centers without surgical backup.

She also noted that the writing committee also received input that “by restricting the use of certain devices such as atherectomy, some patients who needed it as a bailout could be harmed.”

Another factor in prompting the statement update, Dr. Grines said: “Many hospitals have consolidated into heath systems, and these systems consolidated bypass surgery into one center. Therefore, centers with high volume, experienced operators, and excellent outcomes were now left with no surgery on site. It didn’t make sense to withdraw complex PCI from these centers who haven’t sent a patient for emergency bypass in several years.”
 

Statement guidance

The centerpiece of the update is an algorithm that covers the range of settings for PCI, from having a surgeon on site to ACS or office-based lab.

For example, indications for on-site surgical capability are PCI of the last remaining patent vessel or retrograde approach to epicardial chronic total occlusion (CTO), and when the patient is a candidate for surgery.

Indications for PCI in a hospital without on-site surgery but with percutaneous ventricular assist device or extracorporeal membrane oxygenation, calcium modification devices and high PCI volume are patients with decreased left ventricular ejection fraction, unprotected left main artery, CTO, or degenerated vein grafts.

For patients at high risk for transfusion, acute kidney injury or vascular complications, or who have high baseline respiratory risk, a hospital without on-site surgery but with respiratory care, blood bank, and vascular surgery services is indicated.

And for patients with none of the aforementioned characteristics or risks, ASC, office-based lab, or any hospital facility is acceptable.

The statement also provides guidance for operator experience. Those with less than 3 years’ experience, considered to have limited exposure to atherectomy devices and limited ST-segmented elevation MI (STEMI)/shock experience, should avoid doing PCIs in an ASC and performing atherectomy cases on their own, and have a colleague review case selection and assist in higher-risk cases. Experienced (3-10 years’ experience) and very experienced (more than 10 years’) should be able to perform in any setting and be competent with, if not highly experienced with, atherectomy and STEMI/shock.

Dr. Grines acknowledged the writing group didn’t want to set a specific operator volume requirement. “However, we recognize that lifetime operator experience is particularly important in more complex cases such as CTO, atherectomy, bifurcation stenoses, etc.,” she said. “In addition, performing these cases at a larger institution that has other operators that may assist in the event of a complication is very important. Specifically, we did not believe that recent fellow graduates with less than 3 years in practice or low-volume operators should attempt higher-risk cases in a no-SOS [surgeon-on-site] setting or perform cases in ASC or office-based labs where no colleagues are there to assist in case of a complication.”

In an interview, Gregory J. Dehmer, MD, professor of medicine at Virginia Tech University, Roanoke, reprised the theme of his accompanying editorial. “Things are evolving again, as Bob Dylan would say, ‘The Times They Are A-Changin’, so it’s very timely that the society in collaboration with other professional societies updated what are guidelines and rules of road if you’re going to do PCI in ASCs or office based laboratories,” said Dr. Dehmer, who chaired the writing committees of the 2007 and 2014 SCAI expert statements on PCI.

Having this statement is important for centers that don’t have on-site surgical backup, he said. “You couldn’t sustain a PCI operation at a rural hospital on just acute MIs alone. The key thing is that all of this built upon numerous studies both in the U.S. and abroad that showed the safety of doing elective cases – not only STEMIs, but elective PCI – at facilities without on-site surgery.”

CMS pushed the envelope when it decided to reimburse PCIs done in ASCs, Dr. Dehmer said. “That was not based on a lot of data. It was kind of a leap of faith. It’s logical that this should work, but in order for it to work and be safe for pats you have to follow the rules. That’s where SCAI stepped in at this point and said this is a whole new environment and we need to set some ground rules for physicians of who and who should not be having these procures in an office-based lab or an ambulatory surgery center.”

Dr. Grines and Dr. Dehmer have no relevant disclosures.
 

The Society for Cardiovascular Angiography and Interventions has issued an updated expert consensus statement to provide clearer guidance on what percutaneous coronary angioplasty cases can be done in outpatient settings such as ambulatory surgery centers (ASCs) and office-based laboratories and which are best left to more traditional settings, such as hospitals with full cardiac support.

PCI has evolved quickly since SCAI issued its last update almost 9 years ago. The updated statement, published online in the Journal of the Society for Cardiovascular Angiography and Interventions, notes that the proportion of same-day PCI discharges has increased from 4.5% in 2009 to 28.6% in 2017.

The statement also notes that the Medicare facility fee for outpatient PCI in an ASC is about 40% less than the hospital fee: $6,111 versus $10,258 for the facility fee for 2022. The Centers for Medicare & Medicaid Services in 2020 extended coverage for PCIs in ASCs.
 

Rationale for update

Writing group chair Cindy Grines, MD, explained the rationale for updating the statement now. “The 2014 SCAI statement was very conservative, recommending only the simplest of cases be done without surgical backup,” Dr. Grines, chief scientific officer at Northside Hospital Cardiovascular Institute in Atlanta, said in an interview.

The statement drew on 12 global studies from 2015 to 2022 that evaluated more than 8 million PCIs at facilities with and without surgery on site. Dr. Grines noted those studies reported complication rates as low as 0.1% in PCI procedures in centers without surgical backup.

She also noted that the writing committee also received input that “by restricting the use of certain devices such as atherectomy, some patients who needed it as a bailout could be harmed.”

Another factor in prompting the statement update, Dr. Grines said: “Many hospitals have consolidated into heath systems, and these systems consolidated bypass surgery into one center. Therefore, centers with high volume, experienced operators, and excellent outcomes were now left with no surgery on site. It didn’t make sense to withdraw complex PCI from these centers who haven’t sent a patient for emergency bypass in several years.”
 

Statement guidance

The centerpiece of the update is an algorithm that covers the range of settings for PCI, from having a surgeon on site to ACS or office-based lab.

For example, indications for on-site surgical capability are PCI of the last remaining patent vessel or retrograde approach to epicardial chronic total occlusion (CTO), and when the patient is a candidate for surgery.

Indications for PCI in a hospital without on-site surgery but with percutaneous ventricular assist device or extracorporeal membrane oxygenation, calcium modification devices and high PCI volume are patients with decreased left ventricular ejection fraction, unprotected left main artery, CTO, or degenerated vein grafts.

For patients at high risk for transfusion, acute kidney injury or vascular complications, or who have high baseline respiratory risk, a hospital without on-site surgery but with respiratory care, blood bank, and vascular surgery services is indicated.

And for patients with none of the aforementioned characteristics or risks, ASC, office-based lab, or any hospital facility is acceptable.

The statement also provides guidance for operator experience. Those with less than 3 years’ experience, considered to have limited exposure to atherectomy devices and limited ST-segmented elevation MI (STEMI)/shock experience, should avoid doing PCIs in an ASC and performing atherectomy cases on their own, and have a colleague review case selection and assist in higher-risk cases. Experienced (3-10 years’ experience) and very experienced (more than 10 years’) should be able to perform in any setting and be competent with, if not highly experienced with, atherectomy and STEMI/shock.

Dr. Grines acknowledged the writing group didn’t want to set a specific operator volume requirement. “However, we recognize that lifetime operator experience is particularly important in more complex cases such as CTO, atherectomy, bifurcation stenoses, etc.,” she said. “In addition, performing these cases at a larger institution that has other operators that may assist in the event of a complication is very important. Specifically, we did not believe that recent fellow graduates with less than 3 years in practice or low-volume operators should attempt higher-risk cases in a no-SOS [surgeon-on-site] setting or perform cases in ASC or office-based labs where no colleagues are there to assist in case of a complication.”

In an interview, Gregory J. Dehmer, MD, professor of medicine at Virginia Tech University, Roanoke, reprised the theme of his accompanying editorial. “Things are evolving again, as Bob Dylan would say, ‘The Times They Are A-Changin’, so it’s very timely that the society in collaboration with other professional societies updated what are guidelines and rules of road if you’re going to do PCI in ASCs or office based laboratories,” said Dr. Dehmer, who chaired the writing committees of the 2007 and 2014 SCAI expert statements on PCI.

Having this statement is important for centers that don’t have on-site surgical backup, he said. “You couldn’t sustain a PCI operation at a rural hospital on just acute MIs alone. The key thing is that all of this built upon numerous studies both in the U.S. and abroad that showed the safety of doing elective cases – not only STEMIs, but elective PCI – at facilities without on-site surgery.”

CMS pushed the envelope when it decided to reimburse PCIs done in ASCs, Dr. Dehmer said. “That was not based on a lot of data. It was kind of a leap of faith. It’s logical that this should work, but in order for it to work and be safe for pats you have to follow the rules. That’s where SCAI stepped in at this point and said this is a whole new environment and we need to set some ground rules for physicians of who and who should not be having these procures in an office-based lab or an ambulatory surgery center.”

Dr. Grines and Dr. Dehmer have no relevant disclosures.
 

The Society for Cardiovascular Angiography and Interventions has issued an updated expert consensus statement to provide clearer guidance on what percutaneous coronary angioplasty cases can be done in outpatient settings such as ambulatory surgery centers (ASCs) and office-based laboratories and which are best left to more traditional settings, such as hospitals with full cardiac support.

PCI has evolved quickly since SCAI issued its last update almost 9 years ago. The updated statement, published online in the Journal of the Society for Cardiovascular Angiography and Interventions, notes that the proportion of same-day PCI discharges has increased from 4.5% in 2009 to 28.6% in 2017.

The statement also notes that the Medicare facility fee for outpatient PCI in an ASC is about 40% less than the hospital fee: $6,111 versus $10,258 for the facility fee for 2022. The Centers for Medicare & Medicaid Services in 2020 extended coverage for PCIs in ASCs.
 

Rationale for update

Writing group chair Cindy Grines, MD, explained the rationale for updating the statement now. “The 2014 SCAI statement was very conservative, recommending only the simplest of cases be done without surgical backup,” Dr. Grines, chief scientific officer at Northside Hospital Cardiovascular Institute in Atlanta, said in an interview.

The statement drew on 12 global studies from 2015 to 2022 that evaluated more than 8 million PCIs at facilities with and without surgery on site. Dr. Grines noted those studies reported complication rates as low as 0.1% in PCI procedures in centers without surgical backup.

She also noted that the writing committee also received input that “by restricting the use of certain devices such as atherectomy, some patients who needed it as a bailout could be harmed.”

Another factor in prompting the statement update, Dr. Grines said: “Many hospitals have consolidated into heath systems, and these systems consolidated bypass surgery into one center. Therefore, centers with high volume, experienced operators, and excellent outcomes were now left with no surgery on site. It didn’t make sense to withdraw complex PCI from these centers who haven’t sent a patient for emergency bypass in several years.”
 

Statement guidance

The centerpiece of the update is an algorithm that covers the range of settings for PCI, from having a surgeon on site to ACS or office-based lab.

For example, indications for on-site surgical capability are PCI of the last remaining patent vessel or retrograde approach to epicardial chronic total occlusion (CTO), and when the patient is a candidate for surgery.

Indications for PCI in a hospital without on-site surgery but with percutaneous ventricular assist device or extracorporeal membrane oxygenation, calcium modification devices and high PCI volume are patients with decreased left ventricular ejection fraction, unprotected left main artery, CTO, or degenerated vein grafts.

For patients at high risk for transfusion, acute kidney injury or vascular complications, or who have high baseline respiratory risk, a hospital without on-site surgery but with respiratory care, blood bank, and vascular surgery services is indicated.

And for patients with none of the aforementioned characteristics or risks, ASC, office-based lab, or any hospital facility is acceptable.

The statement also provides guidance for operator experience. Those with less than 3 years’ experience, considered to have limited exposure to atherectomy devices and limited ST-segmented elevation MI (STEMI)/shock experience, should avoid doing PCIs in an ASC and performing atherectomy cases on their own, and have a colleague review case selection and assist in higher-risk cases. Experienced (3-10 years’ experience) and very experienced (more than 10 years’) should be able to perform in any setting and be competent with, if not highly experienced with, atherectomy and STEMI/shock.

Dr. Grines acknowledged the writing group didn’t want to set a specific operator volume requirement. “However, we recognize that lifetime operator experience is particularly important in more complex cases such as CTO, atherectomy, bifurcation stenoses, etc.,” she said. “In addition, performing these cases at a larger institution that has other operators that may assist in the event of a complication is very important. Specifically, we did not believe that recent fellow graduates with less than 3 years in practice or low-volume operators should attempt higher-risk cases in a no-SOS [surgeon-on-site] setting or perform cases in ASC or office-based labs where no colleagues are there to assist in case of a complication.”

In an interview, Gregory J. Dehmer, MD, professor of medicine at Virginia Tech University, Roanoke, reprised the theme of his accompanying editorial. “Things are evolving again, as Bob Dylan would say, ‘The Times They Are A-Changin’, so it’s very timely that the society in collaboration with other professional societies updated what are guidelines and rules of road if you’re going to do PCI in ASCs or office based laboratories,” said Dr. Dehmer, who chaired the writing committees of the 2007 and 2014 SCAI expert statements on PCI.

Having this statement is important for centers that don’t have on-site surgical backup, he said. “You couldn’t sustain a PCI operation at a rural hospital on just acute MIs alone. The key thing is that all of this built upon numerous studies both in the U.S. and abroad that showed the safety of doing elective cases – not only STEMIs, but elective PCI – at facilities without on-site surgery.”

CMS pushed the envelope when it decided to reimburse PCIs done in ASCs, Dr. Dehmer said. “That was not based on a lot of data. It was kind of a leap of faith. It’s logical that this should work, but in order for it to work and be safe for pats you have to follow the rules. That’s where SCAI stepped in at this point and said this is a whole new environment and we need to set some ground rules for physicians of who and who should not be having these procures in an office-based lab or an ambulatory surgery center.”

Dr. Grines and Dr. Dehmer have no relevant disclosures.
 

The reproductive hormone kisspeptin may be a treatment option for low sexual desire in men and women, according to results from two small randomized controlled trials.

The data suggest that injections of kisspeptin can boost sexual desire in men and women and can increase penile rigidity in men.

Together, these two studies provide proof of concept for the development of kisspeptin-based therapeutics for men and women with distressing hypoactive sexual desire disorder (HSDD), study investigator Alexander Comninos, MD, PhD, Imperial College London, said in a news release.

One study was published online Feb. 3, 2022, in JAMA Network Open. The other was published in October 2022.
 

Unmet need

HSDD affects up to 10% of women and 8% of men worldwide and leads to psychological and social harm, the news release noted.

“There is a real unmet need to find new, safer, and more effective therapies for this distressing condition for both women and men seeking treatment,” Dr. Comninos said.

Kisspeptin is a naturally occurring reproductive hormone that serves as a crucial activator of the reproductive system. Emerging evidence from animal models shows that kisspeptin signaling has key roles in modulating reproductive behavior, including sexual motivation and erections.

In a double-blind, placebo-controlled, crossover study, the researchers enrolled 32 healthy heterosexual men (mean age, 37.9 years) who had HSDD.

At the first study visit, the men were given an infusion of kisspeptin-54 (1 nmol/kg per hour) or placebo (saline) over 75 minutes. The participants then crossed over to the other treatment at a second study visit at least 7 days later.

The active treatment significantly increased circulating kisspeptin levels. A steady state was reached after 30-75 minutes of infusion, the researchers reported.
 

Similar data in men, women

While the men viewed sexual videos, kisspeptin significantly modulated brain activity on fMRI in key structures of the sexual-processing network, compared with placebo (P = .003).

In addition, the treatment led to significant increases in penile tumescence in response to sexual stimuli (by up to 56% more than placebo; P = .02) and behavioral measures of sexual desire – most notably increased happiness about sex (P = .02).

Given the significant stimulatory effect of kisspeptin administration on penile rigidity, coupled with its demonstrated proerectile effect in rodents, future studies should examine the use of kisspeptin for patients with erectile dysfunction, the researchers wrote.

The second study included 32 women with HSDD and had the same design. Its results also showed that kisspeptin restored sexual and attraction brain processing without adverse effects.

“It is highly encouraging to see the same boosting effect in both women and men, although the precise brain pathways were slightly different, as might be expected,” coinvestigator Waljit Dhillo, PhD, Imperial College London, said in the news release.

“Collectively, the results suggest that kisspeptin may offer a safe and much-needed treatment for HSDD that affects millions of people around the world; and we look forward to taking this forward in future larger studies and in other patient groups,” Dr. Dhillo added.

The study was funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and the Medical Research Council, part of UK Research and Innovation. Dr. Comninos reported no relevant financial relationships. Dr. Dhillo reported receiving consulting fees from Myovant Sciences and KaNDy Therapeutics outside the submitted work.

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

The reproductive hormone kisspeptin may be a treatment option for low sexual desire in men and women, according to results from two small randomized controlled trials.

The data suggest that injections of kisspeptin can boost sexual desire in men and women and can increase penile rigidity in men.

Together, these two studies provide proof of concept for the development of kisspeptin-based therapeutics for men and women with distressing hypoactive sexual desire disorder (HSDD), study investigator Alexander Comninos, MD, PhD, Imperial College London, said in a news release.

One study was published online Feb. 3, 2022, in JAMA Network Open. The other was published in October 2022.
 

Unmet need

HSDD affects up to 10% of women and 8% of men worldwide and leads to psychological and social harm, the news release noted.

“There is a real unmet need to find new, safer, and more effective therapies for this distressing condition for both women and men seeking treatment,” Dr. Comninos said.

Kisspeptin is a naturally occurring reproductive hormone that serves as a crucial activator of the reproductive system. Emerging evidence from animal models shows that kisspeptin signaling has key roles in modulating reproductive behavior, including sexual motivation and erections.

In a double-blind, placebo-controlled, crossover study, the researchers enrolled 32 healthy heterosexual men (mean age, 37.9 years) who had HSDD.

At the first study visit, the men were given an infusion of kisspeptin-54 (1 nmol/kg per hour) or placebo (saline) over 75 minutes. The participants then crossed over to the other treatment at a second study visit at least 7 days later.

The active treatment significantly increased circulating kisspeptin levels. A steady state was reached after 30-75 minutes of infusion, the researchers reported.
 

Similar data in men, women

While the men viewed sexual videos, kisspeptin significantly modulated brain activity on fMRI in key structures of the sexual-processing network, compared with placebo (P = .003).

In addition, the treatment led to significant increases in penile tumescence in response to sexual stimuli (by up to 56% more than placebo; P = .02) and behavioral measures of sexual desire – most notably increased happiness about sex (P = .02).

Given the significant stimulatory effect of kisspeptin administration on penile rigidity, coupled with its demonstrated proerectile effect in rodents, future studies should examine the use of kisspeptin for patients with erectile dysfunction, the researchers wrote.

The second study included 32 women with HSDD and had the same design. Its results also showed that kisspeptin restored sexual and attraction brain processing without adverse effects.

“It is highly encouraging to see the same boosting effect in both women and men, although the precise brain pathways were slightly different, as might be expected,” coinvestigator Waljit Dhillo, PhD, Imperial College London, said in the news release.

“Collectively, the results suggest that kisspeptin may offer a safe and much-needed treatment for HSDD that affects millions of people around the world; and we look forward to taking this forward in future larger studies and in other patient groups,” Dr. Dhillo added.

The study was funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and the Medical Research Council, part of UK Research and Innovation. Dr. Comninos reported no relevant financial relationships. Dr. Dhillo reported receiving consulting fees from Myovant Sciences and KaNDy Therapeutics outside the submitted work.

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

The reproductive hormone kisspeptin may be a treatment option for low sexual desire in men and women, according to results from two small randomized controlled trials.

The data suggest that injections of kisspeptin can boost sexual desire in men and women and can increase penile rigidity in men.

Together, these two studies provide proof of concept for the development of kisspeptin-based therapeutics for men and women with distressing hypoactive sexual desire disorder (HSDD), study investigator Alexander Comninos, MD, PhD, Imperial College London, said in a news release.

One study was published online Feb. 3, 2022, in JAMA Network Open. The other was published in October 2022.
 

Unmet need

HSDD affects up to 10% of women and 8% of men worldwide and leads to psychological and social harm, the news release noted.

“There is a real unmet need to find new, safer, and more effective therapies for this distressing condition for both women and men seeking treatment,” Dr. Comninos said.

Kisspeptin is a naturally occurring reproductive hormone that serves as a crucial activator of the reproductive system. Emerging evidence from animal models shows that kisspeptin signaling has key roles in modulating reproductive behavior, including sexual motivation and erections.

In a double-blind, placebo-controlled, crossover study, the researchers enrolled 32 healthy heterosexual men (mean age, 37.9 years) who had HSDD.

At the first study visit, the men were given an infusion of kisspeptin-54 (1 nmol/kg per hour) or placebo (saline) over 75 minutes. The participants then crossed over to the other treatment at a second study visit at least 7 days later.

The active treatment significantly increased circulating kisspeptin levels. A steady state was reached after 30-75 minutes of infusion, the researchers reported.
 

Similar data in men, women

While the men viewed sexual videos, kisspeptin significantly modulated brain activity on fMRI in key structures of the sexual-processing network, compared with placebo (P = .003).

In addition, the treatment led to significant increases in penile tumescence in response to sexual stimuli (by up to 56% more than placebo; P = .02) and behavioral measures of sexual desire – most notably increased happiness about sex (P = .02).

Given the significant stimulatory effect of kisspeptin administration on penile rigidity, coupled with its demonstrated proerectile effect in rodents, future studies should examine the use of kisspeptin for patients with erectile dysfunction, the researchers wrote.

The second study included 32 women with HSDD and had the same design. Its results also showed that kisspeptin restored sexual and attraction brain processing without adverse effects.

“It is highly encouraging to see the same boosting effect in both women and men, although the precise brain pathways were slightly different, as might be expected,” coinvestigator Waljit Dhillo, PhD, Imperial College London, said in the news release.

“Collectively, the results suggest that kisspeptin may offer a safe and much-needed treatment for HSDD that affects millions of people around the world; and we look forward to taking this forward in future larger studies and in other patient groups,” Dr. Dhillo added.

The study was funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and the Medical Research Council, part of UK Research and Innovation. Dr. Comninos reported no relevant financial relationships. Dr. Dhillo reported receiving consulting fees from Myovant Sciences and KaNDy Therapeutics outside the submitted work.

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

A diet high in flavonoids, such as black tea, can help prevent abdominal aortic calcification (AAC) in women later in life, according to the Heart Foundation and researchers from Edith Cowan University, Perth, Australia.

What to know

• Elderly women who drank black tea on a regular basis or consumed a high level of flavonoids in their diet were found to be far less likely to develop extensive AAC.
• AAC is calcification of the large artery that supplies oxygenated blood from the heart to the abdominal organs and lower limbs. It is associated with cardiovascular disorders, such as heart attack and stroke, as well as late-life dementia.
• Flavonoids are naturally occurring substances that regulate cellular activity. They are found in many common foods and beverages, such as black tea, green tea, apples, nuts, citrus fruit, berries, red wine, dark chocolate, and others.
• Study participants who had a higher intake of total flavonoids, flavan-3-ols, and flavonols were almost 40% less likely to have extensive AAC, while those who drank two to six cups of black tea per day had up to 42% less chance of experiencing extensive AAC.
• People who do not drink tea can still benefit by including foods rich in flavonoids in their diet, which protects against extensive calcification of the arteries.
•  

This is a summary of the article, “Higher Habitual Dietary Flavonoid Intake Associates With Less Extensive Abdominal Aortic Calcification in a Cohort of Older Women,” published in Arteriosclerosis, Thrombosis, and Vascular Biology on Nov. 2, 2022. The full article can be found on ahajournals.org. A version of this article originally appeared on Medscape.com.

A diet high in flavonoids, such as black tea, can help prevent abdominal aortic calcification (AAC) in women later in life, according to the Heart Foundation and researchers from Edith Cowan University, Perth, Australia.

What to know

• Elderly women who drank black tea on a regular basis or consumed a high level of flavonoids in their diet were found to be far less likely to develop extensive AAC.
• AAC is calcification of the large artery that supplies oxygenated blood from the heart to the abdominal organs and lower limbs. It is associated with cardiovascular disorders, such as heart attack and stroke, as well as late-life dementia.
• Flavonoids are naturally occurring substances that regulate cellular activity. They are found in many common foods and beverages, such as black tea, green tea, apples, nuts, citrus fruit, berries, red wine, dark chocolate, and others.
• Study participants who had a higher intake of total flavonoids, flavan-3-ols, and flavonols were almost 40% less likely to have extensive AAC, while those who drank two to six cups of black tea per day had up to 42% less chance of experiencing extensive AAC.
• People who do not drink tea can still benefit by including foods rich in flavonoids in their diet, which protects against extensive calcification of the arteries.
•  

This is a summary of the article, “Higher Habitual Dietary Flavonoid Intake Associates With Less Extensive Abdominal Aortic Calcification in a Cohort of Older Women,” published in Arteriosclerosis, Thrombosis, and Vascular Biology on Nov. 2, 2022. The full article can be found on ahajournals.org. A version of this article originally appeared on Medscape.com.

A diet high in flavonoids, such as black tea, can help prevent abdominal aortic calcification (AAC) in women later in life, according to the Heart Foundation and researchers from Edith Cowan University, Perth, Australia.

What to know

• Elderly women who drank black tea on a regular basis or consumed a high level of flavonoids in their diet were found to be far less likely to develop extensive AAC.
• AAC is calcification of the large artery that supplies oxygenated blood from the heart to the abdominal organs and lower limbs. It is associated with cardiovascular disorders, such as heart attack and stroke, as well as late-life dementia.
• Flavonoids are naturally occurring substances that regulate cellular activity. They are found in many common foods and beverages, such as black tea, green tea, apples, nuts, citrus fruit, berries, red wine, dark chocolate, and others.
• Study participants who had a higher intake of total flavonoids, flavan-3-ols, and flavonols were almost 40% less likely to have extensive AAC, while those who drank two to six cups of black tea per day had up to 42% less chance of experiencing extensive AAC.
• People who do not drink tea can still benefit by including foods rich in flavonoids in their diet, which protects against extensive calcification of the arteries.
•  

This is a summary of the article, “Higher Habitual Dietary Flavonoid Intake Associates With Less Extensive Abdominal Aortic Calcification in a Cohort of Older Women,” published in Arteriosclerosis, Thrombosis, and Vascular Biology on Nov. 2, 2022. The full article can be found on ahajournals.org. A version of this article originally appeared on Medscape.com.

Men and women aged 35 and older with severe obesity who had bariatric surgery had improved survival up to 4 decades afterward compared with individuals of the same age, sex, and body mass index who did not undergo surgery.

Death from cardiovascular disease, cancer, and diabetes was 29%, 43%, and 72% lower, respectively, in the bariatric surgery patients versus nonsurgery peers, during a mean follow-up of 13 years (all P > .001).

However, the youngest group of bariatric surgery patients – who were 18-34 years old – had a fivefold increased risk of suicide during follow-up compared with their peers who did not undergo surgery (P = .001).  

These findings are from a retrospective study in Utah that matched close to 22,000 patients with severe obesity who underwent Roux-en-Y gastric bypass, gastric banding, sleeve gastrectomy, or duodenal switch from 1982 to 2018 with an equal number of nonsurgery individuals.  

The study, by Ted D. Adams, PhD, MPH, and colleagues, was published online in Obesity.
 

‘Impressive’ data, in men too, but psychological screening important 

The overall improved survival and decreased deaths from diabetes, heart disease, and cancer over this long follow-up are “impressive,” Dr. Adams, of Intermountain Surgical Specialties/Digestive Health Clinical Program, Salt Lake City, said in an interview.

Previous studies have not shown a survival benefit from bariatric surgery versus no surgery in men, he said. However, “because we had a fair number of male patients and because of the length of follow-up, we did show that the improved mortality was not only evident for the female patients but also for the male patients,” Dr. Adams stressed.

Finding increased suicide rates among bariatric surgical patients who underwent surgery at a younger age (18-34 years) shows that “we need to try and determine who is at risk for suicide,” according to Dr. Adams.  

Patients with severe obesity, especially younger ones, “may need more aggressive presurgical psychological screening and postsurgery follow-up,” wrote Dr. Adams and colleagues.

The findings may also “stimulate important research related to the discovery of physiologic and biomolecular mechanisms leading to nonsurgical treatment that results in weight loss and improved mortality similar to that achieved by bariatric surgery,” they suggested. 
 

Close to 1 in 10 Americans has severe obesity

The prevalence of severe obesity (BMI ≥ 40 kg/m²) in the United States has increased from 4.7% during 1999-2000 to 9.2% during 2017-2018, based on National Health and Nutrition Examination Survey (NHANES) data, the researchers noted.

They previously published a study of long-term mortality in 7,925 patients who had gastric bypass surgery from 1984 to 2002 matched with patients with the same BMI who did not have bariatric surgery and were followed out to 2002.

The current study extends the follow-up through 2021, doubles the number of bypass patients, and includes three newer types of bariatric surgery.  

The researchers matched 21,873 patients aged 18-80 who had Roux-en-Y gastric bypass, gastric banding, sleeve gastrectomy, or duodenal switch during 1982-2018 in Utah (from the Utah Population Database) with people of the same BMI category, age category (18-34, 35-44, 45-54, and 55-80 years), and sex (from Utah driver license data).

Most patients were women (79%) and most were White (94% and 85%). They had a mean age of 42 years and a mean BMI of 46 kg/m².

Most patients had Roux-en-Y gastric bypass (69%), and the rest had sleeve gastrectomy (14%), gastric banding (12%), and duodenal switch (4.8%).

During follow-up, 13.5% of patients in the bariatric surgery group and 14.6% of people in the nonsurgery group died.

Overall, all-cause mortality was 16% lower in patients who had bariatric surgery versus matched nonsurgical participants; it was 14% lower in women and 21% lower in men (all P < .001).

All-cause mortality was significantly lower in patients who had bariatric surgery when they were 35-44, 45-54, and 55-80 years old compared with matched peers who did not have surgery.

However, the findings “should not imply patients necessarily postpone surgery until older age,” the researchers cautioned, “as postsurgical complications have been shown to increase with increasing age at surgery and surgical postponement may result in worsened clinical status related to certain conditions such as orthopedic joint health.”

The researchers found significantly improved all-cause mortality following either type of surgery (gastric bypass, gastric banding, and sleeve gastrectomy) compared with no surgery.

Along with fewer deaths from cardiovascular disease, cancer, and diabetes, deaths from lung disease were 39% lower in the surgery group than in the nonsurgery group.

However, in the youngest group (age 18-34), deaths from cirrhosis of the liver were significantly higher in the patients who had bariatric surgery, and rates of suicide were significantly greater for both females and males, compared with similar people who did not undergo surgery.  

The study was supported by grants from Ethicon Endo-Surgery (Johnson & Johnson); the National Institute of Diabetes and Digestive and Kidney Diseases, a division of the National Institutes of Health; U.S. Public Health Service; and Intermountain Research and Medical Foundation of Intermountain Healthcare. Dr. Adams disclosed ties to Ethicon Endo-Surgery and Intermountain Healthcare. A coauthor reported ties with Biomedical Research Program at Weill Cornell Medicine in Qatar, a program funded by the Qatar Foundation. The other authors have reported no relevant financial relationships.

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

Men and women aged 35 and older with severe obesity who had bariatric surgery had improved survival up to 4 decades afterward compared with individuals of the same age, sex, and body mass index who did not undergo surgery.

Death from cardiovascular disease, cancer, and diabetes was 29%, 43%, and 72% lower, respectively, in the bariatric surgery patients versus nonsurgery peers, during a mean follow-up of 13 years (all P > .001).

However, the youngest group of bariatric surgery patients – who were 18-34 years old – had a fivefold increased risk of suicide during follow-up compared with their peers who did not undergo surgery (P = .001).  

These findings are from a retrospective study in Utah that matched close to 22,000 patients with severe obesity who underwent Roux-en-Y gastric bypass, gastric banding, sleeve gastrectomy, or duodenal switch from 1982 to 2018 with an equal number of nonsurgery individuals.  

The study, by Ted D. Adams, PhD, MPH, and colleagues, was published online in Obesity.
 

‘Impressive’ data, in men too, but psychological screening important 

The overall improved survival and decreased deaths from diabetes, heart disease, and cancer over this long follow-up are “impressive,” Dr. Adams, of Intermountain Surgical Specialties/Digestive Health Clinical Program, Salt Lake City, said in an interview.

Previous studies have not shown a survival benefit from bariatric surgery versus no surgery in men, he said. However, “because we had a fair number of male patients and because of the length of follow-up, we did show that the improved mortality was not only evident for the female patients but also for the male patients,” Dr. Adams stressed.

Finding increased suicide rates among bariatric surgical patients who underwent surgery at a younger age (18-34 years) shows that “we need to try and determine who is at risk for suicide,” according to Dr. Adams.  

Patients with severe obesity, especially younger ones, “may need more aggressive presurgical psychological screening and postsurgery follow-up,” wrote Dr. Adams and colleagues.

The findings may also “stimulate important research related to the discovery of physiologic and biomolecular mechanisms leading to nonsurgical treatment that results in weight loss and improved mortality similar to that achieved by bariatric surgery,” they suggested. 
 

Close to 1 in 10 Americans has severe obesity

The prevalence of severe obesity (BMI ≥ 40 kg/m²) in the United States has increased from 4.7% during 1999-2000 to 9.2% during 2017-2018, based on National Health and Nutrition Examination Survey (NHANES) data, the researchers noted.

They previously published a study of long-term mortality in 7,925 patients who had gastric bypass surgery from 1984 to 2002 matched with patients with the same BMI who did not have bariatric surgery and were followed out to 2002.

The current study extends the follow-up through 2021, doubles the number of bypass patients, and includes three newer types of bariatric surgery.  

The researchers matched 21,873 patients aged 18-80 who had Roux-en-Y gastric bypass, gastric banding, sleeve gastrectomy, or duodenal switch during 1982-2018 in Utah (from the Utah Population Database) with people of the same BMI category, age category (18-34, 35-44, 45-54, and 55-80 years), and sex (from Utah driver license data).

Most patients were women (79%) and most were White (94% and 85%). They had a mean age of 42 years and a mean BMI of 46 kg/m².

Most patients had Roux-en-Y gastric bypass (69%), and the rest had sleeve gastrectomy (14%), gastric banding (12%), and duodenal switch (4.8%).

During follow-up, 13.5% of patients in the bariatric surgery group and 14.6% of people in the nonsurgery group died.

Overall, all-cause mortality was 16% lower in patients who had bariatric surgery versus matched nonsurgical participants; it was 14% lower in women and 21% lower in men (all P < .001).

All-cause mortality was significantly lower in patients who had bariatric surgery when they were 35-44, 45-54, and 55-80 years old compared with matched peers who did not have surgery.

However, the findings “should not imply patients necessarily postpone surgery until older age,” the researchers cautioned, “as postsurgical complications have been shown to increase with increasing age at surgery and surgical postponement may result in worsened clinical status related to certain conditions such as orthopedic joint health.”

The researchers found significantly improved all-cause mortality following either type of surgery (gastric bypass, gastric banding, and sleeve gastrectomy) compared with no surgery.

Along with fewer deaths from cardiovascular disease, cancer, and diabetes, deaths from lung disease were 39% lower in the surgery group than in the nonsurgery group.

However, in the youngest group (age 18-34), deaths from cirrhosis of the liver were significantly higher in the patients who had bariatric surgery, and rates of suicide were significantly greater for both females and males, compared with similar people who did not undergo surgery.  

The study was supported by grants from Ethicon Endo-Surgery (Johnson & Johnson); the National Institute of Diabetes and Digestive and Kidney Diseases, a division of the National Institutes of Health; U.S. Public Health Service; and Intermountain Research and Medical Foundation of Intermountain Healthcare. Dr. Adams disclosed ties to Ethicon Endo-Surgery and Intermountain Healthcare. A coauthor reported ties with Biomedical Research Program at Weill Cornell Medicine in Qatar, a program funded by the Qatar Foundation. The other authors have reported no relevant financial relationships.

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

Men and women aged 35 and older with severe obesity who had bariatric surgery had improved survival up to 4 decades afterward compared with individuals of the same age, sex, and body mass index who did not undergo surgery.

Death from cardiovascular disease, cancer, and diabetes was 29%, 43%, and 72% lower, respectively, in the bariatric surgery patients versus nonsurgery peers, during a mean follow-up of 13 years (all P > .001).

However, the youngest group of bariatric surgery patients – who were 18-34 years old – had a fivefold increased risk of suicide during follow-up compared with their peers who did not undergo surgery (P = .001).  

These findings are from a retrospective study in Utah that matched close to 22,000 patients with severe obesity who underwent Roux-en-Y gastric bypass, gastric banding, sleeve gastrectomy, or duodenal switch from 1982 to 2018 with an equal number of nonsurgery individuals.  

The study, by Ted D. Adams, PhD, MPH, and colleagues, was published online in Obesity.
 

‘Impressive’ data, in men too, but psychological screening important 

The overall improved survival and decreased deaths from diabetes, heart disease, and cancer over this long follow-up are “impressive,” Dr. Adams, of Intermountain Surgical Specialties/Digestive Health Clinical Program, Salt Lake City, said in an interview.

Previous studies have not shown a survival benefit from bariatric surgery versus no surgery in men, he said. However, “because we had a fair number of male patients and because of the length of follow-up, we did show that the improved mortality was not only evident for the female patients but also for the male patients,” Dr. Adams stressed.

Finding increased suicide rates among bariatric surgical patients who underwent surgery at a younger age (18-34 years) shows that “we need to try and determine who is at risk for suicide,” according to Dr. Adams.  

Patients with severe obesity, especially younger ones, “may need more aggressive presurgical psychological screening and postsurgery follow-up,” wrote Dr. Adams and colleagues.

The findings may also “stimulate important research related to the discovery of physiologic and biomolecular mechanisms leading to nonsurgical treatment that results in weight loss and improved mortality similar to that achieved by bariatric surgery,” they suggested. 
 

Close to 1 in 10 Americans has severe obesity

The prevalence of severe obesity (BMI ≥ 40 kg/m²) in the United States has increased from 4.7% during 1999-2000 to 9.2% during 2017-2018, based on National Health and Nutrition Examination Survey (NHANES) data, the researchers noted.

They previously published a study of long-term mortality in 7,925 patients who had gastric bypass surgery from 1984 to 2002 matched with patients with the same BMI who did not have bariatric surgery and were followed out to 2002.

The current study extends the follow-up through 2021, doubles the number of bypass patients, and includes three newer types of bariatric surgery.  

The researchers matched 21,873 patients aged 18-80 who had Roux-en-Y gastric bypass, gastric banding, sleeve gastrectomy, or duodenal switch during 1982-2018 in Utah (from the Utah Population Database) with people of the same BMI category, age category (18-34, 35-44, 45-54, and 55-80 years), and sex (from Utah driver license data).

Most patients were women (79%) and most were White (94% and 85%). They had a mean age of 42 years and a mean BMI of 46 kg/m².

Most patients had Roux-en-Y gastric bypass (69%), and the rest had sleeve gastrectomy (14%), gastric banding (12%), and duodenal switch (4.8%).

During follow-up, 13.5% of patients in the bariatric surgery group and 14.6% of people in the nonsurgery group died.

Overall, all-cause mortality was 16% lower in patients who had bariatric surgery versus matched nonsurgical participants; it was 14% lower in women and 21% lower in men (all P < .001).

All-cause mortality was significantly lower in patients who had bariatric surgery when they were 35-44, 45-54, and 55-80 years old compared with matched peers who did not have surgery.

However, the findings “should not imply patients necessarily postpone surgery until older age,” the researchers cautioned, “as postsurgical complications have been shown to increase with increasing age at surgery and surgical postponement may result in worsened clinical status related to certain conditions such as orthopedic joint health.”

The researchers found significantly improved all-cause mortality following either type of surgery (gastric bypass, gastric banding, and sleeve gastrectomy) compared with no surgery.

Along with fewer deaths from cardiovascular disease, cancer, and diabetes, deaths from lung disease were 39% lower in the surgery group than in the nonsurgery group.

However, in the youngest group (age 18-34), deaths from cirrhosis of the liver were significantly higher in the patients who had bariatric surgery, and rates of suicide were significantly greater for both females and males, compared with similar people who did not undergo surgery.  

The study was supported by grants from Ethicon Endo-Surgery (Johnson & Johnson); the National Institute of Diabetes and Digestive and Kidney Diseases, a division of the National Institutes of Health; U.S. Public Health Service; and Intermountain Research and Medical Foundation of Intermountain Healthcare. Dr. Adams disclosed ties to Ethicon Endo-Surgery and Intermountain Healthcare. A coauthor reported ties with Biomedical Research Program at Weill Cornell Medicine in Qatar, a program funded by the Qatar Foundation. The other authors have reported no relevant financial relationships.

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

All women, regardless of their risk profile, should consider prophylactic removal of the fallopian tubes at the same time as other pelvic surgery once they are finished having children, the Ovarian Cancer Research Alliance has advised.

The recommendation, announced Feb. 1, replaces the decades-old focus on symptom awareness and early detection and follows “sobering and deeply disappointing” results from a large U.K. study published 2 years ago, the organization said.

That was the UK Collaborative Trial of Ovarian Cancer Screening published in The Lancet in 2021, which followed more than 200,000 women for a median 16 years. It showed that screening average-risk women with a CA-125 blood test and ultrasound does not reduce deaths from the disease, as reported at the time by this news organization.

“We all hoped that the trial would show that early detection was effective in changing mortality rates. When the results came out, it was very hard to accept,” Audra Moran, OCRA president and CEO, said in an interview.

“We have an obligation to let people know that symptom awareness and early detection will not save lives” but considering opportunistic salpingectomy “absolutely will,” said Ms. Moran. Hence the renewed call for women to consider having their fallopian tubes removed.  

What sounds new about this call is that the group is directing fallopian tube removal to all women “who are undergoing pelvic surgeries for benign conditions,” irrespective of what perceived risk they have of developing ovarian cancer (for example, based on family history).

But this advice has been in place for years for women who are known to be at higher risk for the disease.

For instance, women at high risk for ovarian cancer based on Hereditary Breast and Ovarian Cancer Syndrome (HBOC) have long been recommended to undergo surgery to remove ovaries and fallopian tubes (risk-reducing bilateral salpingo-oophorectomy or RRBSO) once there is no longer a desire for pregnancy.

Approached for comment about the new messaging, Stephanie V. Blank, MD, president of the Society of Gynecologic Oncology, says that the new recommendation – that all women who are finished childbearing consider opportunistic salpingectomy at the time of other pelvic surgery for benign conditions – is “not aggressive.”

“It’s reasonable and makes sense,” Dr. Blank said in an interview.

And she pointed out that it’s actually not “new”; it is, however, getting “new attention” based on the disappointing U.K. screening study, said Dr. Blank, director of gynecologic oncology for the Mount Sinai Health System in New York and professor of gynecologic oncology at Icahn School of Medicine at Mount Sinai.

She noted that the procedure of opportunistic salpingectomy has been endorsed by SGO since 2013 and by the American College of Obstetricians and Gynecologists since 2015.

There is increasing evidence that most high-grade serous ovarian cancers arise from cells in the fallopian tubes, William Dahut, MD, chief scientific officer for the American Cancer Society, told this news organization.

“Indirect evidence suggests a fairly strong degree of risk reduction associated with opportunistic salpingectomy for the most prevalent type of ovarian cancer (serous), and some risk reduction of epithelial ovarian cancer. At this time, these discussions seem warranted,” Dr. Dahut said.

At this point, however, the fact that leading organizations advise “consideration” means that the evidence base has “not been judged to be sufficiently strong (in terms of what we can say about benefits and harms) to advise a direct recommendation for opportunistic salpingectomy,” Dr. Dahut added.

There is no current recommendation to have fallopian tubes removed as a stand-alone procedure, he pointed out. However, he commented that “the occasion of scheduled gynecologic surgery presents an opportunity to possibly reduce the risk of ovarian cancer without known adverse effects in women who have completed childbearing. Having the discussion seems to be justified by the current evidence,” Dr. Dahut said.

Deanna Gerber, MD, a gynecologic oncologist at NYU Langone Perlmutter Cancer Center-Long Island, agrees. “In women who are scheduled to have a gynecologic or pelvic procedure, clinicians should discuss the possibility of removing the fallopian tubes at that time. A salpingectomy is a relatively low-risk procedure and adds little time to the surgery,” Dr. Gerber said in an interview.

“Women should understand that there is still ongoing research on this topic, but this low-risk procedure may reduce their risk of developing an ovarian or fallopian tube cancer,” Dr. Gerber said.

OCRA also encourages all women (or anyone born with ovaries) to know their risk for ovarian cancer. To that end, the organization has launched a pilot program offering free, at-home genetic testing kits to people with a personal or family history of breast, ovarian, uterine, or colorectal cancer.

Ms. Moran, Dr. Blank, Dr. Dahut, and Dr. Gerber report no relevant financial relationships.

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

All women, regardless of their risk profile, should consider prophylactic removal of the fallopian tubes at the same time as other pelvic surgery once they are finished having children, the Ovarian Cancer Research Alliance has advised.

The recommendation, announced Feb. 1, replaces the decades-old focus on symptom awareness and early detection and follows “sobering and deeply disappointing” results from a large U.K. study published 2 years ago, the organization said.

That was the UK Collaborative Trial of Ovarian Cancer Screening published in The Lancet in 2021, which followed more than 200,000 women for a median 16 years. It showed that screening average-risk women with a CA-125 blood test and ultrasound does not reduce deaths from the disease, as reported at the time by this news organization.

“We all hoped that the trial would show that early detection was effective in changing mortality rates. When the results came out, it was very hard to accept,” Audra Moran, OCRA president and CEO, said in an interview.

“We have an obligation to let people know that symptom awareness and early detection will not save lives” but considering opportunistic salpingectomy “absolutely will,” said Ms. Moran. Hence the renewed call for women to consider having their fallopian tubes removed.  

What sounds new about this call is that the group is directing fallopian tube removal to all women “who are undergoing pelvic surgeries for benign conditions,” irrespective of what perceived risk they have of developing ovarian cancer (for example, based on family history).

But this advice has been in place for years for women who are known to be at higher risk for the disease.

For instance, women at high risk for ovarian cancer based on Hereditary Breast and Ovarian Cancer Syndrome (HBOC) have long been recommended to undergo surgery to remove ovaries and fallopian tubes (risk-reducing bilateral salpingo-oophorectomy or RRBSO) once there is no longer a desire for pregnancy.

Approached for comment about the new messaging, Stephanie V. Blank, MD, president of the Society of Gynecologic Oncology, says that the new recommendation – that all women who are finished childbearing consider opportunistic salpingectomy at the time of other pelvic surgery for benign conditions – is “not aggressive.”

“It’s reasonable and makes sense,” Dr. Blank said in an interview.

And she pointed out that it’s actually not “new”; it is, however, getting “new attention” based on the disappointing U.K. screening study, said Dr. Blank, director of gynecologic oncology for the Mount Sinai Health System in New York and professor of gynecologic oncology at Icahn School of Medicine at Mount Sinai.

She noted that the procedure of opportunistic salpingectomy has been endorsed by SGO since 2013 and by the American College of Obstetricians and Gynecologists since 2015.

There is increasing evidence that most high-grade serous ovarian cancers arise from cells in the fallopian tubes, William Dahut, MD, chief scientific officer for the American Cancer Society, told this news organization.

“Indirect evidence suggests a fairly strong degree of risk reduction associated with opportunistic salpingectomy for the most prevalent type of ovarian cancer (serous), and some risk reduction of epithelial ovarian cancer. At this time, these discussions seem warranted,” Dr. Dahut said.

At this point, however, the fact that leading organizations advise “consideration” means that the evidence base has “not been judged to be sufficiently strong (in terms of what we can say about benefits and harms) to advise a direct recommendation for opportunistic salpingectomy,” Dr. Dahut added.

There is no current recommendation to have fallopian tubes removed as a stand-alone procedure, he pointed out. However, he commented that “the occasion of scheduled gynecologic surgery presents an opportunity to possibly reduce the risk of ovarian cancer without known adverse effects in women who have completed childbearing. Having the discussion seems to be justified by the current evidence,” Dr. Dahut said.

Deanna Gerber, MD, a gynecologic oncologist at NYU Langone Perlmutter Cancer Center-Long Island, agrees. “In women who are scheduled to have a gynecologic or pelvic procedure, clinicians should discuss the possibility of removing the fallopian tubes at that time. A salpingectomy is a relatively low-risk procedure and adds little time to the surgery,” Dr. Gerber said in an interview.

“Women should understand that there is still ongoing research on this topic, but this low-risk procedure may reduce their risk of developing an ovarian or fallopian tube cancer,” Dr. Gerber said.

OCRA also encourages all women (or anyone born with ovaries) to know their risk for ovarian cancer. To that end, the organization has launched a pilot program offering free, at-home genetic testing kits to people with a personal or family history of breast, ovarian, uterine, or colorectal cancer.

Ms. Moran, Dr. Blank, Dr. Dahut, and Dr. Gerber report no relevant financial relationships.

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

All women, regardless of their risk profile, should consider prophylactic removal of the fallopian tubes at the same time as other pelvic surgery once they are finished having children, the Ovarian Cancer Research Alliance has advised.

The recommendation, announced Feb. 1, replaces the decades-old focus on symptom awareness and early detection and follows “sobering and deeply disappointing” results from a large U.K. study published 2 years ago, the organization said.

That was the UK Collaborative Trial of Ovarian Cancer Screening published in The Lancet in 2021, which followed more than 200,000 women for a median 16 years. It showed that screening average-risk women with a CA-125 blood test and ultrasound does not reduce deaths from the disease, as reported at the time by this news organization.

“We all hoped that the trial would show that early detection was effective in changing mortality rates. When the results came out, it was very hard to accept,” Audra Moran, OCRA president and CEO, said in an interview.

“We have an obligation to let people know that symptom awareness and early detection will not save lives” but considering opportunistic salpingectomy “absolutely will,” said Ms. Moran. Hence the renewed call for women to consider having their fallopian tubes removed.  

What sounds new about this call is that the group is directing fallopian tube removal to all women “who are undergoing pelvic surgeries for benign conditions,” irrespective of what perceived risk they have of developing ovarian cancer (for example, based on family history).

But this advice has been in place for years for women who are known to be at higher risk for the disease.

For instance, women at high risk for ovarian cancer based on Hereditary Breast and Ovarian Cancer Syndrome (HBOC) have long been recommended to undergo surgery to remove ovaries and fallopian tubes (risk-reducing bilateral salpingo-oophorectomy or RRBSO) once there is no longer a desire for pregnancy.

Approached for comment about the new messaging, Stephanie V. Blank, MD, president of the Society of Gynecologic Oncology, says that the new recommendation – that all women who are finished childbearing consider opportunistic salpingectomy at the time of other pelvic surgery for benign conditions – is “not aggressive.”

“It’s reasonable and makes sense,” Dr. Blank said in an interview.

And she pointed out that it’s actually not “new”; it is, however, getting “new attention” based on the disappointing U.K. screening study, said Dr. Blank, director of gynecologic oncology for the Mount Sinai Health System in New York and professor of gynecologic oncology at Icahn School of Medicine at Mount Sinai.

She noted that the procedure of opportunistic salpingectomy has been endorsed by SGO since 2013 and by the American College of Obstetricians and Gynecologists since 2015.

There is increasing evidence that most high-grade serous ovarian cancers arise from cells in the fallopian tubes, William Dahut, MD, chief scientific officer for the American Cancer Society, told this news organization.

“Indirect evidence suggests a fairly strong degree of risk reduction associated with opportunistic salpingectomy for the most prevalent type of ovarian cancer (serous), and some risk reduction of epithelial ovarian cancer. At this time, these discussions seem warranted,” Dr. Dahut said.

At this point, however, the fact that leading organizations advise “consideration” means that the evidence base has “not been judged to be sufficiently strong (in terms of what we can say about benefits and harms) to advise a direct recommendation for opportunistic salpingectomy,” Dr. Dahut added.

There is no current recommendation to have fallopian tubes removed as a stand-alone procedure, he pointed out. However, he commented that “the occasion of scheduled gynecologic surgery presents an opportunity to possibly reduce the risk of ovarian cancer without known adverse effects in women who have completed childbearing. Having the discussion seems to be justified by the current evidence,” Dr. Dahut said.

Deanna Gerber, MD, a gynecologic oncologist at NYU Langone Perlmutter Cancer Center-Long Island, agrees. “In women who are scheduled to have a gynecologic or pelvic procedure, clinicians should discuss the possibility of removing the fallopian tubes at that time. A salpingectomy is a relatively low-risk procedure and adds little time to the surgery,” Dr. Gerber said in an interview.

“Women should understand that there is still ongoing research on this topic, but this low-risk procedure may reduce their risk of developing an ovarian or fallopian tube cancer,” Dr. Gerber said.

OCRA also encourages all women (or anyone born with ovaries) to know their risk for ovarian cancer. To that end, the organization has launched a pilot program offering free, at-home genetic testing kits to people with a personal or family history of breast, ovarian, uterine, or colorectal cancer.

Ms. Moran, Dr. Blank, Dr. Dahut, and Dr. Gerber report no relevant financial relationships.

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

Measures enacted in the early days of the COVID-19 pandemic to increase access to buprenorphine did not lead to an increase in the proportion of overdose deaths involving the drug, new research suggests.

Researchers say the data add weight to the argument for permanently adopting the pandemic-era prescribing regulations for buprenorphine, a treatment for opioid use disorder.

“We saw no evidence that increased availability of buprenorphine through the loosening of rules around prescribing and dispensing of buprenorphine during the pandemic increased overdose deaths,” investigator Wilson Compton, MD, deputy director of the National Institute on Drug Abuse, told this news organization.

“This is reassuring that, even when we opened up the doors to easier access to buprenorphine, we didn’t see that most serious consequence,” Dr. Compton said.

The findings were published online in JAMA Network Open .
 

Cause and effect

Federal agencies relaxed prescribing regulations for buprenorphine in March 2020 to make it easier for clinicians to prescribe the drug via telemedicine and for patients to take the medication at home.

The number of buprenorphine prescriptions has increased since that change, with more than 1 million people receiving the medication in 2021 from retail pharmacies in the United States.

However, questions remained about whether increased access would lead to an increase in buprenorphine-involved overdose.

Researchers with NIDA and the Centers for Disease Control and Prevention analyzed data from the State Unintentional Drug Overdose Reporting System, a CDC database that combines medical examiner and coroner reports and postmortem toxicology testing.

The study included information about overdose deaths from July 2019 to June 2021 in 46 states and the District of Columbia.

Between July 2019 and June 2021, there were 1,955 buprenorphine-involved overdose deaths, which accounted for 2.2% of all drug overdose deaths and 2.6% of opioid-involved overdose deaths.

However, researchers went beyond overall numbers and evaluated details from coroner’s and medical examiner reports, something they had not done before.

“For the first time we looked at the characteristics of decedents from buprenorphine because this has not been studied in this type of detail with a near-national sample,” Dr. Compton said.

“That allowed us to look at patterns of use of other substances as well as the circumstances that are recorded at the death scene that are in the data set,” he added.
 

Important insights

Reports from nearly all buprenorphine-involved deaths included the presence of at least one other drug, compared with opioid overdose deaths that typically involved only one drug.

“This is consistent with the pharmacology of buprenorphine being a partial agonist, so it may not be as fatal all by itself as some of the other opioids,” Dr. Compton said.

Deaths involving buprenorphine were less likely to include illicitly manufactured fentanyls, and other prescription medications were more often found on the scene, such as antidepressants.

Compared with opioid decedents, buprenorphine decedents were more likely to be women, age 35-44, White, and receiving treatment for mental health conditions, including for substance use disorder (SUD).

These kinds of characteristics provide important insights about potential ways to improve safety and clinical outcomes, Dr. Compton noted.

“When we see things like a little higher rate of SUD treatment and this evidence of other prescription drugs on the scene, and some higher rates of antidepressants in these decedents than I might have expected, I’m very curious about their use of other medical services outside of substance use treatment, because that might be a place where some interventions could be implemented,” he said.

A similar study showed pandemic-era policy changes that allowed methadone to be taken at home was followed by a decrease in methadone-related overdose deaths.

The new findings are consistent with those results, Dr. Compton said.
 

‘Chipping away’ at stigma

Commenting on the study, O. Trent Hall, DO, assistant professor of addiction medicine, Department of Psychiatry and Behavioral Health, Ohio State University Wexner Medical Center, Columbus, said that, although he welcomed the findings, they aren’t unexpected.

“Buprenorphine is well established as a safe and effective medication for opioid use disorder and as a physician who routinely cares for patients in the hospital after opioid overdose, I am not at all surprised by these results,” said Dr. Hall, who was not involved with the research.

“When my patients leave the hospital with a buprenorphine prescription, they are much less likely to return with another overdose or serious opioid-related medical problem,” he added.

U.S. drug overdose deaths topped 100,000 for the first time in 2021, and most were opioid-related. Although the latest data from the CDC shows drug overdose deaths have been declining slowly since early 2022, the numbers remain high.

Buprenorphine is one of only two drugs known to reduce the risk of opioid overdose. While prescriptions have increased since 2020, the medication remains underutilized, despite its known effectiveness in treating opioid use disorder.

Dr. Hall noted that research such as the new study could help increase buprenorphine’s use.

“Studies like this one chip away at the stigma that has been misapplied to buprenorphine,” he said. “I hope this article will encourage more providers to offer buprenorphine to patients with opioid use disorder.”

The study was funded internally by NIDA and the CDC. Dr. Compton reported owning stock in General Electric, 3M, and Pfizer outside the submitted work. Dr. Hall has disclosed no relevant financial relationships.

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

Measures enacted in the early days of the COVID-19 pandemic to increase access to buprenorphine did not lead to an increase in the proportion of overdose deaths involving the drug, new research suggests.

Researchers say the data add weight to the argument for permanently adopting the pandemic-era prescribing regulations for buprenorphine, a treatment for opioid use disorder.

“We saw no evidence that increased availability of buprenorphine through the loosening of rules around prescribing and dispensing of buprenorphine during the pandemic increased overdose deaths,” investigator Wilson Compton, MD, deputy director of the National Institute on Drug Abuse, told this news organization.

“This is reassuring that, even when we opened up the doors to easier access to buprenorphine, we didn’t see that most serious consequence,” Dr. Compton said.

The findings were published online in JAMA Network Open .
 

Cause and effect

Federal agencies relaxed prescribing regulations for buprenorphine in March 2020 to make it easier for clinicians to prescribe the drug via telemedicine and for patients to take the medication at home.

The number of buprenorphine prescriptions has increased since that change, with more than 1 million people receiving the medication in 2021 from retail pharmacies in the United States.

However, questions remained about whether increased access would lead to an increase in buprenorphine-involved overdose.

Researchers with NIDA and the Centers for Disease Control and Prevention analyzed data from the State Unintentional Drug Overdose Reporting System, a CDC database that combines medical examiner and coroner reports and postmortem toxicology testing.

The study included information about overdose deaths from July 2019 to June 2021 in 46 states and the District of Columbia.

Between July 2019 and June 2021, there were 1,955 buprenorphine-involved overdose deaths, which accounted for 2.2% of all drug overdose deaths and 2.6% of opioid-involved overdose deaths.

However, researchers went beyond overall numbers and evaluated details from coroner’s and medical examiner reports, something they had not done before.

“For the first time we looked at the characteristics of decedents from buprenorphine because this has not been studied in this type of detail with a near-national sample,” Dr. Compton said.

“That allowed us to look at patterns of use of other substances as well as the circumstances that are recorded at the death scene that are in the data set,” he added.
 

Important insights

Reports from nearly all buprenorphine-involved deaths included the presence of at least one other drug, compared with opioid overdose deaths that typically involved only one drug.

“This is consistent with the pharmacology of buprenorphine being a partial agonist, so it may not be as fatal all by itself as some of the other opioids,” Dr. Compton said.

Deaths involving buprenorphine were less likely to include illicitly manufactured fentanyls, and other prescription medications were more often found on the scene, such as antidepressants.

Compared with opioid decedents, buprenorphine decedents were more likely to be women, age 35-44, White, and receiving treatment for mental health conditions, including for substance use disorder (SUD).

These kinds of characteristics provide important insights about potential ways to improve safety and clinical outcomes, Dr. Compton noted.

“When we see things like a little higher rate of SUD treatment and this evidence of other prescription drugs on the scene, and some higher rates of antidepressants in these decedents than I might have expected, I’m very curious about their use of other medical services outside of substance use treatment, because that might be a place where some interventions could be implemented,” he said.

A similar study showed pandemic-era policy changes that allowed methadone to be taken at home was followed by a decrease in methadone-related overdose deaths.

The new findings are consistent with those results, Dr. Compton said.
 

‘Chipping away’ at stigma

Commenting on the study, O. Trent Hall, DO, assistant professor of addiction medicine, Department of Psychiatry and Behavioral Health, Ohio State University Wexner Medical Center, Columbus, said that, although he welcomed the findings, they aren’t unexpected.

“Buprenorphine is well established as a safe and effective medication for opioid use disorder and as a physician who routinely cares for patients in the hospital after opioid overdose, I am not at all surprised by these results,” said Dr. Hall, who was not involved with the research.

“When my patients leave the hospital with a buprenorphine prescription, they are much less likely to return with another overdose or serious opioid-related medical problem,” he added.

U.S. drug overdose deaths topped 100,000 for the first time in 2021, and most were opioid-related. Although the latest data from the CDC shows drug overdose deaths have been declining slowly since early 2022, the numbers remain high.

Buprenorphine is one of only two drugs known to reduce the risk of opioid overdose. While prescriptions have increased since 2020, the medication remains underutilized, despite its known effectiveness in treating opioid use disorder.

Dr. Hall noted that research such as the new study could help increase buprenorphine’s use.

“Studies like this one chip away at the stigma that has been misapplied to buprenorphine,” he said. “I hope this article will encourage more providers to offer buprenorphine to patients with opioid use disorder.”

The study was funded internally by NIDA and the CDC. Dr. Compton reported owning stock in General Electric, 3M, and Pfizer outside the submitted work. Dr. Hall has disclosed no relevant financial relationships.

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

Measures enacted in the early days of the COVID-19 pandemic to increase access to buprenorphine did not lead to an increase in the proportion of overdose deaths involving the drug, new research suggests.

Researchers say the data add weight to the argument for permanently adopting the pandemic-era prescribing regulations for buprenorphine, a treatment for opioid use disorder.

“We saw no evidence that increased availability of buprenorphine through the loosening of rules around prescribing and dispensing of buprenorphine during the pandemic increased overdose deaths,” investigator Wilson Compton, MD, deputy director of the National Institute on Drug Abuse, told this news organization.

“This is reassuring that, even when we opened up the doors to easier access to buprenorphine, we didn’t see that most serious consequence,” Dr. Compton said.

The findings were published online in JAMA Network Open .
 

Cause and effect

Federal agencies relaxed prescribing regulations for buprenorphine in March 2020 to make it easier for clinicians to prescribe the drug via telemedicine and for patients to take the medication at home.

The number of buprenorphine prescriptions has increased since that change, with more than 1 million people receiving the medication in 2021 from retail pharmacies in the United States.

However, questions remained about whether increased access would lead to an increase in buprenorphine-involved overdose.

Researchers with NIDA and the Centers for Disease Control and Prevention analyzed data from the State Unintentional Drug Overdose Reporting System, a CDC database that combines medical examiner and coroner reports and postmortem toxicology testing.

The study included information about overdose deaths from July 2019 to June 2021 in 46 states and the District of Columbia.

Between July 2019 and June 2021, there were 1,955 buprenorphine-involved overdose deaths, which accounted for 2.2% of all drug overdose deaths and 2.6% of opioid-involved overdose deaths.

However, researchers went beyond overall numbers and evaluated details from coroner’s and medical examiner reports, something they had not done before.

“For the first time we looked at the characteristics of decedents from buprenorphine because this has not been studied in this type of detail with a near-national sample,” Dr. Compton said.

“That allowed us to look at patterns of use of other substances as well as the circumstances that are recorded at the death scene that are in the data set,” he added.
 

Important insights

Reports from nearly all buprenorphine-involved deaths included the presence of at least one other drug, compared with opioid overdose deaths that typically involved only one drug.

“This is consistent with the pharmacology of buprenorphine being a partial agonist, so it may not be as fatal all by itself as some of the other opioids,” Dr. Compton said.

Deaths involving buprenorphine were less likely to include illicitly manufactured fentanyls, and other prescription medications were more often found on the scene, such as antidepressants.

Compared with opioid decedents, buprenorphine decedents were more likely to be women, age 35-44, White, and receiving treatment for mental health conditions, including for substance use disorder (SUD).

These kinds of characteristics provide important insights about potential ways to improve safety and clinical outcomes, Dr. Compton noted.

“When we see things like a little higher rate of SUD treatment and this evidence of other prescription drugs on the scene, and some higher rates of antidepressants in these decedents than I might have expected, I’m very curious about their use of other medical services outside of substance use treatment, because that might be a place where some interventions could be implemented,” he said.

A similar study showed pandemic-era policy changes that allowed methadone to be taken at home was followed by a decrease in methadone-related overdose deaths.

The new findings are consistent with those results, Dr. Compton said.
 

‘Chipping away’ at stigma

Commenting on the study, O. Trent Hall, DO, assistant professor of addiction medicine, Department of Psychiatry and Behavioral Health, Ohio State University Wexner Medical Center, Columbus, said that, although he welcomed the findings, they aren’t unexpected.

“Buprenorphine is well established as a safe and effective medication for opioid use disorder and as a physician who routinely cares for patients in the hospital after opioid overdose, I am not at all surprised by these results,” said Dr. Hall, who was not involved with the research.

“When my patients leave the hospital with a buprenorphine prescription, they are much less likely to return with another overdose or serious opioid-related medical problem,” he added.

U.S. drug overdose deaths topped 100,000 for the first time in 2021, and most were opioid-related. Although the latest data from the CDC shows drug overdose deaths have been declining slowly since early 2022, the numbers remain high.

Buprenorphine is one of only two drugs known to reduce the risk of opioid overdose. While prescriptions have increased since 2020, the medication remains underutilized, despite its known effectiveness in treating opioid use disorder.

Dr. Hall noted that research such as the new study could help increase buprenorphine’s use.

“Studies like this one chip away at the stigma that has been misapplied to buprenorphine,” he said. “I hope this article will encourage more providers to offer buprenorphine to patients with opioid use disorder.”

The study was funded internally by NIDA and the CDC. Dr. Compton reported owning stock in General Electric, 3M, and Pfizer outside the submitted work. Dr. Hall has disclosed no relevant financial relationships.

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

Transcranial magnetic stimulation (TMS) is associated with both anxiolytic and antidepressant effects in patients with anxious depression, new research suggests.

In an analysis of data from more than 1,800 patients with a diagnosis of major depressive disorder (MDD), more than 75% also had anxiety. Following TMS, those with anxious depression showed reductions from baseline of at least 50% on anxiety and depression scores.

In addition, the anxious and nonanxious groups had equivalent absolute improvement in scores measuring depression.

“The ultimate message is that TMS is quite effective in the more difficult-to-treat and more disabled group of anxious depressives,” coinvestigator Scott Aaronson, MD, chief science officer, Institute for Advanced Diagnostics and Therapeutics, and director of the Psychedelic Center of Excellence, Sheppard Pratt, Towson, Md., told this news organization.

The findings were published online in the Journal of Clinical Psychiatry.
 

Large cohort

Dr. Aaronson noted that between 50% and 75% of patients with depression also have significant anxiety symptoms.

“The presence of significant anxiety in a depressed person significantly increases depression symptom severity, functional impairment, chronicity, and suicidality,” he said.

In general, “when patients with anxious depression are identified in a treatment study, they are less likely to respond to the index treatment and are frequently excluded from some treatment trials,” he added.

Dr. Aaronson noted that previously reported outcomes from TMS for anxious depression have been “suggestive of efficacy but have not been well studied within a large cohort.” 

To investigate these issues, the current investigators turned to the NeuroStar Advanced Therapy System Clinical Outcomes Registry. It is the largest database of patients with difficult-to-treat depression, all of whom had undergone TMS.

This “extraordinary” database was able to provide previous insight into how often TMS works, whether some of the treatment parameters can be altered while still preserving efficacy, and whether bilateral TMS works better than unilateral TMS in patients with MDD, Dr. Aaronson said.

In the current study, researchers retrospectively analyzed data on 1,820 patients with MDD. All had completed the Patient Health Questinonaire–9 (PHQ-9) and the Generalized Anxiety Disorder–7 (GAD-7) at baseline and following at least one TMS intervention.

Most patients (n = 1,514) had anxious depression, defined as a baseline GAD-7 score of 10 or higher, and 306 had nonanxious depression, defined as a GAD-7 score below that threshold.

The investigators assessed the total sample of these patients who had been treated with any TMS protocol, as well as a subsample of patients (n = 625) who had been treated only with high-frequency left dorsolateral prefrontal cortex (HF-LUL) stimulation.

Patients were also subdivided into intent-to-treat and Completer samples (n = 1,820 and 1,429, respectively).
 

Consistent effects

There was no difference in gender distribution between the anxious and nonanxious group.

However, the anxious group was significantly younger (by about 5 years), compared with the nonanxious group. They also reported higher severity of depressive symptoms at baseline, with PHQ-9 scores approximately 2.5 points higher.

This was a “notable finding, since the PHQ-9 does not contain items directly assessing anxiety,” the researchers wrote.

There were also differences between the groups in the type of TMS protocol they received, with exclusive HF-LUL more common in the nonanxious depression group compared with other types of TMS protocols or unclassified protocols in the anxious depression group.

“Anxiolytic and antidepressant effects were consistent across the [intent-to-treat] and completed samples and patients who received any TMS protocol or only HF-LUL TMS,” the investigators reported.

GAD-7 scores “decreased markedly” in the anxious depression group. GAD-7 response rates ranged from 47.8% to 60.6% and GAD-7 remission rates ranged from 26.4% to 38.0% (P < .0001 for both).

There were no between-group differences in PHQ-9 scores in the magnitude of change pre- to post treatment. The anxious group scored about 2.5 points higher both pre- and post treatment, compared with the anxious group – with an effect size for change ranging from 1.46 to 1.74 in the anxious group and from 1.66 to 1.95 in the nonanxious group.
 

Response, remission rates

Notably, the anxious and nonanxious groups both showed “marked antidepressant effects,” with response and remission rates in the anxious group ranging from 55.2% to 66.8% and from 24.0% to 33.2%, respectively.

However, response and remission rates were significantly higher in the nonanxious versus the anxious group.

“Thus, despite manifesting the same degree of change in the PHQ-9 scores, the higher baseline and post-TMS scores in the anxious group resulted in significantly lower response and remission rates,” the investigators wrote.

They noted that the difference in post-TMS adjusted means was “small” and the groups also “did not differ in the absolute extent of symptoms improvement after multivariate adjustment.”

The relationship changes in the GAD-7 and the PHQ-9 scores “covaried” for the total IT sample (r1818 = 0.69, P < .001), although the relation was more “robust” in the anxious depression group versus the nonanxious depression group (r1512 = .75 vs. r304 = 0.50; P < .001 for both).

“The anxious depressed folks were sicker and had higher scores on scales capturing the severity of their illness,” Dr. Aaronson said. However, their “outcomes were similar, taking into account the higher baseline scores which had the effect of lowering the percent of anxious participants who met response and remission criteria.”

He reported that the average decline in depression rating scale scores was not significantly different between the groups, and the decline in depression scores tracked similarly to the decline in anxiety scores, “meaning they strongly covaried.”

The authors noted that a limitation was that, although the data was prospectively gathered, the analyses were retrospective.
 

Settles the debate?

Commenting on the study, Shan Siddiqi, MD, assistant professor of psychiatry at Harvard Medical School, Boston, said clinicians know that patients with comorbid anxiety are less likely to be referred for TMS, “probably because of the longstanding perception that TMS doesn’t work as well for them.”

courtesy Brigham and Women’s Medical Center

This perception “has persisted, despite several small studies to the contrary, perhaps because we know that these patients are less responsive to other treatments,” said Dr. Siddiqi, who is also director of psychiatric neuromodulation research at Brigham and Women’s Center for Brain Circuit Therapeutics in Boston. He was not involved with the current research.

“This new study will hopefully settle that debate and let us move on to a new question: How do we optimize the treatment for this important patient population that has largely been excluded from many of our prior studies?”  

The NeuroStar Advanced Therapy System Clinical Outcomes Registry, analysis of the registry data, and the drafting of this manuscript were supported by Neuronetics Inc. Dr. Aaronson serves as a scientific adviser to Genomind, LivaNova, Neuronetics, Janssen Pharmaceuticals, and Sage Therapeutics; and has received research support from Compass Pathways and Neuronetics. Dr. Siddiqi is a scientific consultant for Magnus Medical; a clinical consultant for Acacia Mental Health, Kaizen Brain Center, and Boston Precision Neurotherapeutics; and has received investigator-initiated research funding from Neuronetics and BrainsWay. He has also served as a speaker for BrainsWay and PsychU.org, owns stock in BrainsWay and Magnus Medical, and owns intellectual property involving the use of functional connectivity to target TMS.

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

Transcranial magnetic stimulation (TMS) is associated with both anxiolytic and antidepressant effects in patients with anxious depression, new research suggests.

In an analysis of data from more than 1,800 patients with a diagnosis of major depressive disorder (MDD), more than 75% also had anxiety. Following TMS, those with anxious depression showed reductions from baseline of at least 50% on anxiety and depression scores.

In addition, the anxious and nonanxious groups had equivalent absolute improvement in scores measuring depression.

“The ultimate message is that TMS is quite effective in the more difficult-to-treat and more disabled group of anxious depressives,” coinvestigator Scott Aaronson, MD, chief science officer, Institute for Advanced Diagnostics and Therapeutics, and director of the Psychedelic Center of Excellence, Sheppard Pratt, Towson, Md., told this news organization.

The findings were published online in the Journal of Clinical Psychiatry.
 

Large cohort

Dr. Aaronson noted that between 50% and 75% of patients with depression also have significant anxiety symptoms.

“The presence of significant anxiety in a depressed person significantly increases depression symptom severity, functional impairment, chronicity, and suicidality,” he said.

In general, “when patients with anxious depression are identified in a treatment study, they are less likely to respond to the index treatment and are frequently excluded from some treatment trials,” he added.

Dr. Aaronson noted that previously reported outcomes from TMS for anxious depression have been “suggestive of efficacy but have not been well studied within a large cohort.” 

To investigate these issues, the current investigators turned to the NeuroStar Advanced Therapy System Clinical Outcomes Registry. It is the largest database of patients with difficult-to-treat depression, all of whom had undergone TMS.

This “extraordinary” database was able to provide previous insight into how often TMS works, whether some of the treatment parameters can be altered while still preserving efficacy, and whether bilateral TMS works better than unilateral TMS in patients with MDD, Dr. Aaronson said.

In the current study, researchers retrospectively analyzed data on 1,820 patients with MDD. All had completed the Patient Health Questinonaire–9 (PHQ-9) and the Generalized Anxiety Disorder–7 (GAD-7) at baseline and following at least one TMS intervention.

Most patients (n = 1,514) had anxious depression, defined as a baseline GAD-7 score of 10 or higher, and 306 had nonanxious depression, defined as a GAD-7 score below that threshold.

The investigators assessed the total sample of these patients who had been treated with any TMS protocol, as well as a subsample of patients (n = 625) who had been treated only with high-frequency left dorsolateral prefrontal cortex (HF-LUL) stimulation.

Patients were also subdivided into intent-to-treat and Completer samples (n = 1,820 and 1,429, respectively).
 

Consistent effects

There was no difference in gender distribution between the anxious and nonanxious group.

However, the anxious group was significantly younger (by about 5 years), compared with the nonanxious group. They also reported higher severity of depressive symptoms at baseline, with PHQ-9 scores approximately 2.5 points higher.

This was a “notable finding, since the PHQ-9 does not contain items directly assessing anxiety,” the researchers wrote.

There were also differences between the groups in the type of TMS protocol they received, with exclusive HF-LUL more common in the nonanxious depression group compared with other types of TMS protocols or unclassified protocols in the anxious depression group.

“Anxiolytic and antidepressant effects were consistent across the [intent-to-treat] and completed samples and patients who received any TMS protocol or only HF-LUL TMS,” the investigators reported.

GAD-7 scores “decreased markedly” in the anxious depression group. GAD-7 response rates ranged from 47.8% to 60.6% and GAD-7 remission rates ranged from 26.4% to 38.0% (P < .0001 for both).

There were no between-group differences in PHQ-9 scores in the magnitude of change pre- to post treatment. The anxious group scored about 2.5 points higher both pre- and post treatment, compared with the anxious group – with an effect size for change ranging from 1.46 to 1.74 in the anxious group and from 1.66 to 1.95 in the nonanxious group.
 

Response, remission rates

Notably, the anxious and nonanxious groups both showed “marked antidepressant effects,” with response and remission rates in the anxious group ranging from 55.2% to 66.8% and from 24.0% to 33.2%, respectively.

However, response and remission rates were significantly higher in the nonanxious versus the anxious group.

“Thus, despite manifesting the same degree of change in the PHQ-9 scores, the higher baseline and post-TMS scores in the anxious group resulted in significantly lower response and remission rates,” the investigators wrote.

They noted that the difference in post-TMS adjusted means was “small” and the groups also “did not differ in the absolute extent of symptoms improvement after multivariate adjustment.”

The relationship changes in the GAD-7 and the PHQ-9 scores “covaried” for the total IT sample (r1818 = 0.69, P < .001), although the relation was more “robust” in the anxious depression group versus the nonanxious depression group (r1512 = .75 vs. r304 = 0.50; P < .001 for both).

“The anxious depressed folks were sicker and had higher scores on scales capturing the severity of their illness,” Dr. Aaronson said. However, their “outcomes were similar, taking into account the higher baseline scores which had the effect of lowering the percent of anxious participants who met response and remission criteria.”

He reported that the average decline in depression rating scale scores was not significantly different between the groups, and the decline in depression scores tracked similarly to the decline in anxiety scores, “meaning they strongly covaried.”

The authors noted that a limitation was that, although the data was prospectively gathered, the analyses were retrospective.
 

Settles the debate?

Commenting on the study, Shan Siddiqi, MD, assistant professor of psychiatry at Harvard Medical School, Boston, said clinicians know that patients with comorbid anxiety are less likely to be referred for TMS, “probably because of the longstanding perception that TMS doesn’t work as well for them.”

courtesy Brigham and Women’s Medical Center

This perception “has persisted, despite several small studies to the contrary, perhaps because we know that these patients are less responsive to other treatments,” said Dr. Siddiqi, who is also director of psychiatric neuromodulation research at Brigham and Women’s Center for Brain Circuit Therapeutics in Boston. He was not involved with the current research.

“This new study will hopefully settle that debate and let us move on to a new question: How do we optimize the treatment for this important patient population that has largely been excluded from many of our prior studies?”  

The NeuroStar Advanced Therapy System Clinical Outcomes Registry, analysis of the registry data, and the drafting of this manuscript were supported by Neuronetics Inc. Dr. Aaronson serves as a scientific adviser to Genomind, LivaNova, Neuronetics, Janssen Pharmaceuticals, and Sage Therapeutics; and has received research support from Compass Pathways and Neuronetics. Dr. Siddiqi is a scientific consultant for Magnus Medical; a clinical consultant for Acacia Mental Health, Kaizen Brain Center, and Boston Precision Neurotherapeutics; and has received investigator-initiated research funding from Neuronetics and BrainsWay. He has also served as a speaker for BrainsWay and PsychU.org, owns stock in BrainsWay and Magnus Medical, and owns intellectual property involving the use of functional connectivity to target TMS.

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

Transcranial magnetic stimulation (TMS) is associated with both anxiolytic and antidepressant effects in patients with anxious depression, new research suggests.

In an analysis of data from more than 1,800 patients with a diagnosis of major depressive disorder (MDD), more than 75% also had anxiety. Following TMS, those with anxious depression showed reductions from baseline of at least 50% on anxiety and depression scores.

In addition, the anxious and nonanxious groups had equivalent absolute improvement in scores measuring depression.

“The ultimate message is that TMS is quite effective in the more difficult-to-treat and more disabled group of anxious depressives,” coinvestigator Scott Aaronson, MD, chief science officer, Institute for Advanced Diagnostics and Therapeutics, and director of the Psychedelic Center of Excellence, Sheppard Pratt, Towson, Md., told this news organization.

The findings were published online in the Journal of Clinical Psychiatry.
 

Large cohort

Dr. Aaronson noted that between 50% and 75% of patients with depression also have significant anxiety symptoms.

“The presence of significant anxiety in a depressed person significantly increases depression symptom severity, functional impairment, chronicity, and suicidality,” he said.

In general, “when patients with anxious depression are identified in a treatment study, they are less likely to respond to the index treatment and are frequently excluded from some treatment trials,” he added.

Dr. Aaronson noted that previously reported outcomes from TMS for anxious depression have been “suggestive of efficacy but have not been well studied within a large cohort.” 

To investigate these issues, the current investigators turned to the NeuroStar Advanced Therapy System Clinical Outcomes Registry. It is the largest database of patients with difficult-to-treat depression, all of whom had undergone TMS.

This “extraordinary” database was able to provide previous insight into how often TMS works, whether some of the treatment parameters can be altered while still preserving efficacy, and whether bilateral TMS works better than unilateral TMS in patients with MDD, Dr. Aaronson said.

In the current study, researchers retrospectively analyzed data on 1,820 patients with MDD. All had completed the Patient Health Questinonaire–9 (PHQ-9) and the Generalized Anxiety Disorder–7 (GAD-7) at baseline and following at least one TMS intervention.

Most patients (n = 1,514) had anxious depression, defined as a baseline GAD-7 score of 10 or higher, and 306 had nonanxious depression, defined as a GAD-7 score below that threshold.

The investigators assessed the total sample of these patients who had been treated with any TMS protocol, as well as a subsample of patients (n = 625) who had been treated only with high-frequency left dorsolateral prefrontal cortex (HF-LUL) stimulation.

Patients were also subdivided into intent-to-treat and Completer samples (n = 1,820 and 1,429, respectively).
 

Consistent effects

There was no difference in gender distribution between the anxious and nonanxious group.

However, the anxious group was significantly younger (by about 5 years), compared with the nonanxious group. They also reported higher severity of depressive symptoms at baseline, with PHQ-9 scores approximately 2.5 points higher.

This was a “notable finding, since the PHQ-9 does not contain items directly assessing anxiety,” the researchers wrote.

There were also differences between the groups in the type of TMS protocol they received, with exclusive HF-LUL more common in the nonanxious depression group compared with other types of TMS protocols or unclassified protocols in the anxious depression group.

“Anxiolytic and antidepressant effects were consistent across the [intent-to-treat] and completed samples and patients who received any TMS protocol or only HF-LUL TMS,” the investigators reported.

GAD-7 scores “decreased markedly” in the anxious depression group. GAD-7 response rates ranged from 47.8% to 60.6% and GAD-7 remission rates ranged from 26.4% to 38.0% (P < .0001 for both).

There were no between-group differences in PHQ-9 scores in the magnitude of change pre- to post treatment. The anxious group scored about 2.5 points higher both pre- and post treatment, compared with the anxious group – with an effect size for change ranging from 1.46 to 1.74 in the anxious group and from 1.66 to 1.95 in the nonanxious group.
 

Response, remission rates

Notably, the anxious and nonanxious groups both showed “marked antidepressant effects,” with response and remission rates in the anxious group ranging from 55.2% to 66.8% and from 24.0% to 33.2%, respectively.

However, response and remission rates were significantly higher in the nonanxious versus the anxious group.

“Thus, despite manifesting the same degree of change in the PHQ-9 scores, the higher baseline and post-TMS scores in the anxious group resulted in significantly lower response and remission rates,” the investigators wrote.

They noted that the difference in post-TMS adjusted means was “small” and the groups also “did not differ in the absolute extent of symptoms improvement after multivariate adjustment.”

The relationship changes in the GAD-7 and the PHQ-9 scores “covaried” for the total IT sample (r1818 = 0.69, P < .001), although the relation was more “robust” in the anxious depression group versus the nonanxious depression group (r1512 = .75 vs. r304 = 0.50; P < .001 for both).

“The anxious depressed folks were sicker and had higher scores on scales capturing the severity of their illness,” Dr. Aaronson said. However, their “outcomes were similar, taking into account the higher baseline scores which had the effect of lowering the percent of anxious participants who met response and remission criteria.”

He reported that the average decline in depression rating scale scores was not significantly different between the groups, and the decline in depression scores tracked similarly to the decline in anxiety scores, “meaning they strongly covaried.”

The authors noted that a limitation was that, although the data was prospectively gathered, the analyses were retrospective.
 

Settles the debate?

Commenting on the study, Shan Siddiqi, MD, assistant professor of psychiatry at Harvard Medical School, Boston, said clinicians know that patients with comorbid anxiety are less likely to be referred for TMS, “probably because of the longstanding perception that TMS doesn’t work as well for them.”

courtesy Brigham and Women’s Medical Center

This perception “has persisted, despite several small studies to the contrary, perhaps because we know that these patients are less responsive to other treatments,” said Dr. Siddiqi, who is also director of psychiatric neuromodulation research at Brigham and Women’s Center for Brain Circuit Therapeutics in Boston. He was not involved with the current research.

“This new study will hopefully settle that debate and let us move on to a new question: How do we optimize the treatment for this important patient population that has largely been excluded from many of our prior studies?”  

The NeuroStar Advanced Therapy System Clinical Outcomes Registry, analysis of the registry data, and the drafting of this manuscript were supported by Neuronetics Inc. Dr. Aaronson serves as a scientific adviser to Genomind, LivaNova, Neuronetics, Janssen Pharmaceuticals, and Sage Therapeutics; and has received research support from Compass Pathways and Neuronetics. Dr. Siddiqi is a scientific consultant for Magnus Medical; a clinical consultant for Acacia Mental Health, Kaizen Brain Center, and Boston Precision Neurotherapeutics; and has received investigator-initiated research funding from Neuronetics and BrainsWay. He has also served as a speaker for BrainsWay and PsychU.org, owns stock in BrainsWay and Magnus Medical, and owns intellectual property involving the use of functional connectivity to target TMS.

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

Eight Navy sailors have died by suicide in less than a year. The most recent death was on January 23. Three sailors who died in the past 2 months have more than suicide in common: They were all stationed aboard Navy aircraft carriers undergoing refits: the USS George Washington and the USS Theodore Roosevelt. 

These deaths come only a month after the Navy released a report on 3 deaths by suicide on the George Washington, all of which happened in a single week last April. Military.com reported that the ship’s commander, Capt. Brent Gaut, had said 10 sailors had died by suicide in under a year. 

In November and December 2022, at least 4 sailors assigned to the Mid-Atlantic Regional Maintenance Center (MARMC) in Virginia died by suicide, multiplying concerns about a fleetwide mental health crisis. “I was inundated with the amount of hopelessness at that command,” Kayla Arestivo, a counselor brought in to help, told nbcnews.com. Sailors spoke of being overworked, undervalued, and not getting the mental health help they needed. “Part of it is toxic leadership. The sailors immediately pointed that out,” Arestivo said. 

She noted that many of the people assigned to MARMC are on limited duty due to mental or physical disabilities or have personal stressors that prevent them from full unrestricted duty. Electronics technician Kody Lee Decker, for instance, was on limited duty due to mental health issues when he died by suicide on October 29, 2022, according to a friend. Those people, Arestivo suggested, should have been provided help earlier.

Disabilities are not the only potential risk factors, though. Sailors living aboard the George Washington from April 2021 until April 2022 reported difficult and noisy living conditions with shortages of power, running water, and heat, and poor ventilation. Sailors would sleep in their cars or rent rooms in town rather than stay on board. 

The George Washington has been docked at Newport News [Virginia] Shipbuilding for a major overhaul and repairs since 2017 (expected to extend into 2023, nearly 2 years later than the original deadline). The Navy investigation acknowledged “overwhelming” stress and noted that the living conditions created by an “intense and complex” maintenance process were posing hardships for the sailors, including sleep deprivation. (The Theodore Roosevelt has been at the Puget Sound shipyard since August 2021, although none of the sailors live onboard.)

However, the Navy investigation concluded that the 3 April suicide deaths were not directly connected to living conditions. According to the US Fleet Forces Command, “each Sailor was experiencing unique and individualized life stressors, which were contributing factors leading to their deaths.” The 3 suicide deaths were deemed independent events, with no direct correlation among them.

But the report also charged that leaders were oblivious to the problems, and the mental health care the Navy offered was insufficient: “Multiple command members knew or should have known that MASR Mitchell-Sandor [who died by suicide] was experiencing displeasure with Navy life and could have intervened to help him better cope or seek out available support services.”

In the official response to the Navy report, Rear Adm. John Meier, Commander, Naval Air Force Atlantic, noted that he had convened a “second and broader investigation” to assess quality of life issues and other systemic issues for aircraft carriers undergoing extensive maintenance or construction in the Newport News shipyard. “It is safe to say,” he wrote, that “generations of Navy leaders had become accustomed to the reduced quality of life in the shipyard, and accepted the status quo as par for the course…” 

He agreed that the general stress of the environment was not the root cause of the deaths but was “certainly a contributing factor” in at least one case. The report, he said, placed too much emphasis on the sailor’s personal decisions to not improve his own living conditions (he was offered the opportunity to change berthing) and thus placed “too much burden on him for his situation.” Senior enlisted leadership knew that the sailor was sleeping in his car and counseled him, but Meier found no evidence of follow-through. More senior sailors or an assigned mentor should have been there to support the sailor, Meier said, and help him make decisions that were in his best interests. “This was a time for intrusive leadership.”

Adm. Daryl Caudle, Commander, US Fleet Forces Command, advised revising the wording in the report to say “No one at the command knew, or had a reason to know, of MASR [Xavier] Mitchell-Sandor’s previous suicidal ideations.” He also advised modifying the wording with: “Had the Navy been aware of MASR Mitchell-Sandor’s previous suicidal ideations, existing programs and procedures were in place that make it likely that he would have been placed in a ‘do not arm’ status and received necessary care.”

Vice Admiral Kenneth Whitesell, Commander, Naval Air Force, US Pacific Fleet, also endorsed the report findings with some revisions, saying, “We cannot assume these issues are isolated to a single ship, or to shipyards alone. Rather, these 3 tragic losses brought to light the ultimate need to remain laser-focused on providing care and guidance to our sailors.”

The Navy is providing mental health support to sailors, including an embedded mental health team and 2 civilian resiliency counselors who work on the George Washington. According to an action update in the report, Commander, Naval Air Force directed all CVNs and Naval Aviation Units to have a minimum of 1 safeTALK (Suicide Alertness For Everyone; Tell, Ask, Listen and KeepSafe) trained member onboard, and 2 to 3 safeTALK trained personnel in each division no later than December 31, 2022. 

At MARMC, Arestivo was brought in for several mandatory suicide prevention sessions but without systemic changes, she said, “We’re putting Band-Aids on bullet holes.”

She said she told MARMC’s commanding officer, “You will have another one.” The fourth sailor died by suicide 10 days later.

If you or someone you know is having thoughts of suicide, call or text 988 to reach the National Suicide Prevention Lifeline or contact the Veterans Crisis Line. 

Eight Navy sailors have died by suicide in less than a year. The most recent death was on January 23. Three sailors who died in the past 2 months have more than suicide in common: They were all stationed aboard Navy aircraft carriers undergoing refits: the USS George Washington and the USS Theodore Roosevelt. 

These deaths come only a month after the Navy released a report on 3 deaths by suicide on the George Washington, all of which happened in a single week last April. Military.com reported that the ship’s commander, Capt. Brent Gaut, had said 10 sailors had died by suicide in under a year. 

In November and December 2022, at least 4 sailors assigned to the Mid-Atlantic Regional Maintenance Center (MARMC) in Virginia died by suicide, multiplying concerns about a fleetwide mental health crisis. “I was inundated with the amount of hopelessness at that command,” Kayla Arestivo, a counselor brought in to help, told nbcnews.com. Sailors spoke of being overworked, undervalued, and not getting the mental health help they needed. “Part of it is toxic leadership. The sailors immediately pointed that out,” Arestivo said. 

She noted that many of the people assigned to MARMC are on limited duty due to mental or physical disabilities or have personal stressors that prevent them from full unrestricted duty. Electronics technician Kody Lee Decker, for instance, was on limited duty due to mental health issues when he died by suicide on October 29, 2022, according to a friend. Those people, Arestivo suggested, should have been provided help earlier.

Disabilities are not the only potential risk factors, though. Sailors living aboard the George Washington from April 2021 until April 2022 reported difficult and noisy living conditions with shortages of power, running water, and heat, and poor ventilation. Sailors would sleep in their cars or rent rooms in town rather than stay on board. 

The George Washington has been docked at Newport News [Virginia] Shipbuilding for a major overhaul and repairs since 2017 (expected to extend into 2023, nearly 2 years later than the original deadline). The Navy investigation acknowledged “overwhelming” stress and noted that the living conditions created by an “intense and complex” maintenance process were posing hardships for the sailors, including sleep deprivation. (The Theodore Roosevelt has been at the Puget Sound shipyard since August 2021, although none of the sailors live onboard.)

However, the Navy investigation concluded that the 3 April suicide deaths were not directly connected to living conditions. According to the US Fleet Forces Command, “each Sailor was experiencing unique and individualized life stressors, which were contributing factors leading to their deaths.” The 3 suicide deaths were deemed independent events, with no direct correlation among them.

But the report also charged that leaders were oblivious to the problems, and the mental health care the Navy offered was insufficient: “Multiple command members knew or should have known that MASR Mitchell-Sandor [who died by suicide] was experiencing displeasure with Navy life and could have intervened to help him better cope or seek out available support services.”

In the official response to the Navy report, Rear Adm. John Meier, Commander, Naval Air Force Atlantic, noted that he had convened a “second and broader investigation” to assess quality of life issues and other systemic issues for aircraft carriers undergoing extensive maintenance or construction in the Newport News shipyard. “It is safe to say,” he wrote, that “generations of Navy leaders had become accustomed to the reduced quality of life in the shipyard, and accepted the status quo as par for the course…” 

He agreed that the general stress of the environment was not the root cause of the deaths but was “certainly a contributing factor” in at least one case. The report, he said, placed too much emphasis on the sailor’s personal decisions to not improve his own living conditions (he was offered the opportunity to change berthing) and thus placed “too much burden on him for his situation.” Senior enlisted leadership knew that the sailor was sleeping in his car and counseled him, but Meier found no evidence of follow-through. More senior sailors or an assigned mentor should have been there to support the sailor, Meier said, and help him make decisions that were in his best interests. “This was a time for intrusive leadership.”

Adm. Daryl Caudle, Commander, US Fleet Forces Command, advised revising the wording in the report to say “No one at the command knew, or had a reason to know, of MASR [Xavier] Mitchell-Sandor’s previous suicidal ideations.” He also advised modifying the wording with: “Had the Navy been aware of MASR Mitchell-Sandor’s previous suicidal ideations, existing programs and procedures were in place that make it likely that he would have been placed in a ‘do not arm’ status and received necessary care.”

Vice Admiral Kenneth Whitesell, Commander, Naval Air Force, US Pacific Fleet, also endorsed the report findings with some revisions, saying, “We cannot assume these issues are isolated to a single ship, or to shipyards alone. Rather, these 3 tragic losses brought to light the ultimate need to remain laser-focused on providing care and guidance to our sailors.”

The Navy is providing mental health support to sailors, including an embedded mental health team and 2 civilian resiliency counselors who work on the George Washington. According to an action update in the report, Commander, Naval Air Force directed all CVNs and Naval Aviation Units to have a minimum of 1 safeTALK (Suicide Alertness For Everyone; Tell, Ask, Listen and KeepSafe) trained member onboard, and 2 to 3 safeTALK trained personnel in each division no later than December 31, 2022. 

At MARMC, Arestivo was brought in for several mandatory suicide prevention sessions but without systemic changes, she said, “We’re putting Band-Aids on bullet holes.”

She said she told MARMC’s commanding officer, “You will have another one.” The fourth sailor died by suicide 10 days later.

If you or someone you know is having thoughts of suicide, call or text 988 to reach the National Suicide Prevention Lifeline or contact the Veterans Crisis Line. 

Eight Navy sailors have died by suicide in less than a year. The most recent death was on January 23. Three sailors who died in the past 2 months have more than suicide in common: They were all stationed aboard Navy aircraft carriers undergoing refits: the USS George Washington and the USS Theodore Roosevelt. 

These deaths come only a month after the Navy released a report on 3 deaths by suicide on the George Washington, all of which happened in a single week last April. Military.com reported that the ship’s commander, Capt. Brent Gaut, had said 10 sailors had died by suicide in under a year. 

In November and December 2022, at least 4 sailors assigned to the Mid-Atlantic Regional Maintenance Center (MARMC) in Virginia died by suicide, multiplying concerns about a fleetwide mental health crisis. “I was inundated with the amount of hopelessness at that command,” Kayla Arestivo, a counselor brought in to help, told nbcnews.com. Sailors spoke of being overworked, undervalued, and not getting the mental health help they needed. “Part of it is toxic leadership. The sailors immediately pointed that out,” Arestivo said. 

She noted that many of the people assigned to MARMC are on limited duty due to mental or physical disabilities or have personal stressors that prevent them from full unrestricted duty. Electronics technician Kody Lee Decker, for instance, was on limited duty due to mental health issues when he died by suicide on October 29, 2022, according to a friend. Those people, Arestivo suggested, should have been provided help earlier.

Disabilities are not the only potential risk factors, though. Sailors living aboard the George Washington from April 2021 until April 2022 reported difficult and noisy living conditions with shortages of power, running water, and heat, and poor ventilation. Sailors would sleep in their cars or rent rooms in town rather than stay on board. 

The George Washington has been docked at Newport News [Virginia] Shipbuilding for a major overhaul and repairs since 2017 (expected to extend into 2023, nearly 2 years later than the original deadline). The Navy investigation acknowledged “overwhelming” stress and noted that the living conditions created by an “intense and complex” maintenance process were posing hardships for the sailors, including sleep deprivation. (The Theodore Roosevelt has been at the Puget Sound shipyard since August 2021, although none of the sailors live onboard.)

However, the Navy investigation concluded that the 3 April suicide deaths were not directly connected to living conditions. According to the US Fleet Forces Command, “each Sailor was experiencing unique and individualized life stressors, which were contributing factors leading to their deaths.” The 3 suicide deaths were deemed independent events, with no direct correlation among them.

But the report also charged that leaders were oblivious to the problems, and the mental health care the Navy offered was insufficient: “Multiple command members knew or should have known that MASR Mitchell-Sandor [who died by suicide] was experiencing displeasure with Navy life and could have intervened to help him better cope or seek out available support services.”

In the official response to the Navy report, Rear Adm. John Meier, Commander, Naval Air Force Atlantic, noted that he had convened a “second and broader investigation” to assess quality of life issues and other systemic issues for aircraft carriers undergoing extensive maintenance or construction in the Newport News shipyard. “It is safe to say,” he wrote, that “generations of Navy leaders had become accustomed to the reduced quality of life in the shipyard, and accepted the status quo as par for the course…” 

He agreed that the general stress of the environment was not the root cause of the deaths but was “certainly a contributing factor” in at least one case. The report, he said, placed too much emphasis on the sailor’s personal decisions to not improve his own living conditions (he was offered the opportunity to change berthing) and thus placed “too much burden on him for his situation.” Senior enlisted leadership knew that the sailor was sleeping in his car and counseled him, but Meier found no evidence of follow-through. More senior sailors or an assigned mentor should have been there to support the sailor, Meier said, and help him make decisions that were in his best interests. “This was a time for intrusive leadership.”

Adm. Daryl Caudle, Commander, US Fleet Forces Command, advised revising the wording in the report to say “No one at the command knew, or had a reason to know, of MASR [Xavier] Mitchell-Sandor’s previous suicidal ideations.” He also advised modifying the wording with: “Had the Navy been aware of MASR Mitchell-Sandor’s previous suicidal ideations, existing programs and procedures were in place that make it likely that he would have been placed in a ‘do not arm’ status and received necessary care.”

Vice Admiral Kenneth Whitesell, Commander, Naval Air Force, US Pacific Fleet, also endorsed the report findings with some revisions, saying, “We cannot assume these issues are isolated to a single ship, or to shipyards alone. Rather, these 3 tragic losses brought to light the ultimate need to remain laser-focused on providing care and guidance to our sailors.”

The Navy is providing mental health support to sailors, including an embedded mental health team and 2 civilian resiliency counselors who work on the George Washington. According to an action update in the report, Commander, Naval Air Force directed all CVNs and Naval Aviation Units to have a minimum of 1 safeTALK (Suicide Alertness For Everyone; Tell, Ask, Listen and KeepSafe) trained member onboard, and 2 to 3 safeTALK trained personnel in each division no later than December 31, 2022. 

At MARMC, Arestivo was brought in for several mandatory suicide prevention sessions but without systemic changes, she said, “We’re putting Band-Aids on bullet holes.”

She said she told MARMC’s commanding officer, “You will have another one.” The fourth sailor died by suicide 10 days later.

If you or someone you know is having thoughts of suicide, call or text 988 to reach the National Suicide Prevention Lifeline or contact the Veterans Crisis Line. 

Cases of nonventilator-associated hospital-acquired pneumonia (NV-HAP) declined by 32% between 2015 and 2020. Then, of course, COVID-19 changed the trajectory and rates began to rise. After February 2020, the incidence rate rose by 25% among veterans without COVID-19—but by 108% among those who had COVID-19. 

Those are findings from a study by researchers at Rocky Mountain Regional VA Medical Center, Aurora, Colorado. They studied data on 1,567,275 veterans admitted to 135 VA facilities in acute care settings between October 2015 and March 2021, with a stay of at least 48 hours.

They say, to their knowledge, this is the first published report of changes in NV-HAP risk associated with the onset of COVID-19 among all hospitalized veterans in a national health care system.

The questions for the researchers were: What drove the increase in NV-HAP rates? Was it the elevated risk among veterans with COVID-19, reduced NV-HAP prevention measures during the extreme pandemic-related stress on the system, and/or increased patient acuity among hospitalized veterans? 

They concluded that the observed increase in NV-HAP risk among all patients during the COVID-19 pandemic is “likely multifactorial.” The stresses on clinical workload may have hampered fundamental preventive nursing care, such as early mobility programs, consistent oral care, and aspiration precautions. The researchers also cite barriers including wearing personal protective equipment, which affected communication and the ability to get needed supplies to the bedside without cross-contamination.

Among patients with COVID-19 infections, the greater NV-HAP risk could be due to changes in the lower respiratory tract microbiome, disruption of the immune response, and synergism seen with COVID-19 infection. Moreover, they note, placing patients in a prone position to improve oxygenation might have raised the risk of NV-HAP.

The hospitalized veterans in the study also had a high burden of clinical comorbidities. Those with COVID-19 were more likely to have documented diagnosis of dementia in the previous year, compared with COVID-19-negative veterans or those hospitalized before the pandemic began. The researchers point out that dementia increased the risk of microaspiration, which can lead to secondary bacterial pneumonia.

In addition to reinforcing prevention efforts, the researchers suggest that NV-HAP monitoring via automated electronic surveillance could “serve as a cornerstone of a strong infection prevention program.” A system like that, installed before the pandemic, they say, might have identified the NV-HAP risk sooner. 

Most importantly, they add, strategies to reduce NV-HAP risk “should be designed with resilience to significant system stress such as the COVID-19 pandemic.” 

Cases of nonventilator-associated hospital-acquired pneumonia (NV-HAP) declined by 32% between 2015 and 2020. Then, of course, COVID-19 changed the trajectory and rates began to rise. After February 2020, the incidence rate rose by 25% among veterans without COVID-19—but by 108% among those who had COVID-19. 

Those are findings from a study by researchers at Rocky Mountain Regional VA Medical Center, Aurora, Colorado. They studied data on 1,567,275 veterans admitted to 135 VA facilities in acute care settings between October 2015 and March 2021, with a stay of at least 48 hours.

They say, to their knowledge, this is the first published report of changes in NV-HAP risk associated with the onset of COVID-19 among all hospitalized veterans in a national health care system.

The questions for the researchers were: What drove the increase in NV-HAP rates? Was it the elevated risk among veterans with COVID-19, reduced NV-HAP prevention measures during the extreme pandemic-related stress on the system, and/or increased patient acuity among hospitalized veterans? 

They concluded that the observed increase in NV-HAP risk among all patients during the COVID-19 pandemic is “likely multifactorial.” The stresses on clinical workload may have hampered fundamental preventive nursing care, such as early mobility programs, consistent oral care, and aspiration precautions. The researchers also cite barriers including wearing personal protective equipment, which affected communication and the ability to get needed supplies to the bedside without cross-contamination.

Among patients with COVID-19 infections, the greater NV-HAP risk could be due to changes in the lower respiratory tract microbiome, disruption of the immune response, and synergism seen with COVID-19 infection. Moreover, they note, placing patients in a prone position to improve oxygenation might have raised the risk of NV-HAP.

The hospitalized veterans in the study also had a high burden of clinical comorbidities. Those with COVID-19 were more likely to have documented diagnosis of dementia in the previous year, compared with COVID-19-negative veterans or those hospitalized before the pandemic began. The researchers point out that dementia increased the risk of microaspiration, which can lead to secondary bacterial pneumonia.

In addition to reinforcing prevention efforts, the researchers suggest that NV-HAP monitoring via automated electronic surveillance could “serve as a cornerstone of a strong infection prevention program.” A system like that, installed before the pandemic, they say, might have identified the NV-HAP risk sooner. 

Most importantly, they add, strategies to reduce NV-HAP risk “should be designed with resilience to significant system stress such as the COVID-19 pandemic.” 

Cases of nonventilator-associated hospital-acquired pneumonia (NV-HAP) declined by 32% between 2015 and 2020. Then, of course, COVID-19 changed the trajectory and rates began to rise. After February 2020, the incidence rate rose by 25% among veterans without COVID-19—but by 108% among those who had COVID-19. 

Those are findings from a study by researchers at Rocky Mountain Regional VA Medical Center, Aurora, Colorado. They studied data on 1,567,275 veterans admitted to 135 VA facilities in acute care settings between October 2015 and March 2021, with a stay of at least 48 hours.

They say, to their knowledge, this is the first published report of changes in NV-HAP risk associated with the onset of COVID-19 among all hospitalized veterans in a national health care system.

The questions for the researchers were: What drove the increase in NV-HAP rates? Was it the elevated risk among veterans with COVID-19, reduced NV-HAP prevention measures during the extreme pandemic-related stress on the system, and/or increased patient acuity among hospitalized veterans? 

They concluded that the observed increase in NV-HAP risk among all patients during the COVID-19 pandemic is “likely multifactorial.” The stresses on clinical workload may have hampered fundamental preventive nursing care, such as early mobility programs, consistent oral care, and aspiration precautions. The researchers also cite barriers including wearing personal protective equipment, which affected communication and the ability to get needed supplies to the bedside without cross-contamination.

Among patients with COVID-19 infections, the greater NV-HAP risk could be due to changes in the lower respiratory tract microbiome, disruption of the immune response, and synergism seen with COVID-19 infection. Moreover, they note, placing patients in a prone position to improve oxygenation might have raised the risk of NV-HAP.

The hospitalized veterans in the study also had a high burden of clinical comorbidities. Those with COVID-19 were more likely to have documented diagnosis of dementia in the previous year, compared with COVID-19-negative veterans or those hospitalized before the pandemic began. The researchers point out that dementia increased the risk of microaspiration, which can lead to secondary bacterial pneumonia.

In addition to reinforcing prevention efforts, the researchers suggest that NV-HAP monitoring via automated electronic surveillance could “serve as a cornerstone of a strong infection prevention program.” A system like that, installed before the pandemic, they say, might have identified the NV-HAP risk sooner. 

Most importantly, they add, strategies to reduce NV-HAP risk “should be designed with resilience to significant system stress such as the COVID-19 pandemic.” 

A 27-gene immuno-oncology assay appears to provide useful information about whether patients with advanced non–small cell lung cancer (NSCLC) could benefit from immune checkpoint inhibitor (ICI) therapy despite their poor status, researchers reported.

Positive findings on the test, known as DetermaIO, were “associated with efficacy of response to ICI therapy in advanced NSCLC patients,” Matthew G. Varga, PhD, manager of scientific affairs at Oncocyte, said in an interview. “These data suggest that DetermaIO warrants further study in poor performance status patients as it has the potential to identify likely responders to ICI therapy.”

Oncocyte, which is developing the test, presented the findings in a poster at the annual meeting of the Society for Immunotherapy of Cancer.

According to Dr. Varga, “DetermaIO is an RT-qPCR test that can be applied to FFPE [formalin-fixed, paraffin-embedded] tissue specimens to quantify the relative gene expression of 27 genes and subsequently applies our proprietary algorithm to generate an IO score based on the gene expression profile. The DetermaIO score is a binary IO+ or IO– score, representing likely responder or nonresponder, respectively.”

The test was originally developed for triple negative breast cancer, Dr. Varga said, and it’s been validated in non–small cell lung cancer, metastatic urothelial carcinoma, and metastatic colorectal carcinoma.

For the study, the researchers retrospectively tracked associations between DetermaIO score and either progression-free survival (PFS) or overall survival (OS) in 147 patients in Canada with NSCLC who were treated with ICI monotherapy. All had programmed death-ligand 1 (PD-L1) ≥ 50%.

Overall, outcomes were poor: The median survival was 12.7 months, and median PFS was 7.0 months. These outcomes were even worse in those who underwent therapy as a second- line treatment: The median survival was 9.7 months, and median PFS was 4.4 months.

“DetermaIO was significantly associated with PFS at hazard ratio [HR] = 0.55, 95% [confidence interval] CI, 0.32-0.94, P = .028. In our analyses, a hazard ratio less than 1 suggests lower risk – i.e, that DetermaIO+ patients have lower risk of an event – death or progression – compared to a DetermaIO– patient,” Dr. Varga said. “The association for overall survival was not statistically significant, but it was suggestive of clinically meaningful benefit.”

He added that “we could identify likely responders from nonresponders, suggesting that the DetermaIO score adds both independent and incremental data to the existing gold standard biomarker. The objective response rate for all first-line patients – n = 78 – was 44.9%. Twenty-two DetermaIO– tumors had a 23% response rate (5 partial responses) whereas of the 56 DetermaIO+ patients, the response rate was 54% (2 complete response and 28 partial responses).”

A score on the test, he said, was not associated with OS or PFS in patients who received second-line or later treatment.

The study was not designed to evaluate the predictive power of the test. “For a biomarker to be defined as predictive requires a formal test of interaction between a treatment group (ICI monotherapy, for example) vs. a control group (chemo-only or other regimen),” Dr. Varga explained. “In our analysis, there was no group of patients who did not receive ICI monotherapy. Thus a test for interaction and a predictive claim cannot be made.”

The test is available for at no cost via an early access program, Dr. Varga said, and Oncocyte is getting ready to seek Medicare coverage. The ultimate cost of the test, he said, is unknown.

Oncocyte funded this study. Dr. Varga and several other study authors are Oncocyte employees, and another author is a paid consultant to the company.

A 27-gene immuno-oncology assay appears to provide useful information about whether patients with advanced non–small cell lung cancer (NSCLC) could benefit from immune checkpoint inhibitor (ICI) therapy despite their poor status, researchers reported.

Positive findings on the test, known as DetermaIO, were “associated with efficacy of response to ICI therapy in advanced NSCLC patients,” Matthew G. Varga, PhD, manager of scientific affairs at Oncocyte, said in an interview. “These data suggest that DetermaIO warrants further study in poor performance status patients as it has the potential to identify likely responders to ICI therapy.”

Oncocyte, which is developing the test, presented the findings in a poster at the annual meeting of the Society for Immunotherapy of Cancer.

According to Dr. Varga, “DetermaIO is an RT-qPCR test that can be applied to FFPE [formalin-fixed, paraffin-embedded] tissue specimens to quantify the relative gene expression of 27 genes and subsequently applies our proprietary algorithm to generate an IO score based on the gene expression profile. The DetermaIO score is a binary IO+ or IO– score, representing likely responder or nonresponder, respectively.”

The test was originally developed for triple negative breast cancer, Dr. Varga said, and it’s been validated in non–small cell lung cancer, metastatic urothelial carcinoma, and metastatic colorectal carcinoma.

For the study, the researchers retrospectively tracked associations between DetermaIO score and either progression-free survival (PFS) or overall survival (OS) in 147 patients in Canada with NSCLC who were treated with ICI monotherapy. All had programmed death-ligand 1 (PD-L1) ≥ 50%.

Overall, outcomes were poor: The median survival was 12.7 months, and median PFS was 7.0 months. These outcomes were even worse in those who underwent therapy as a second- line treatment: The median survival was 9.7 months, and median PFS was 4.4 months.

“DetermaIO was significantly associated with PFS at hazard ratio [HR] = 0.55, 95% [confidence interval] CI, 0.32-0.94, P = .028. In our analyses, a hazard ratio less than 1 suggests lower risk – i.e, that DetermaIO+ patients have lower risk of an event – death or progression – compared to a DetermaIO– patient,” Dr. Varga said. “The association for overall survival was not statistically significant, but it was suggestive of clinically meaningful benefit.”

He added that “we could identify likely responders from nonresponders, suggesting that the DetermaIO score adds both independent and incremental data to the existing gold standard biomarker. The objective response rate for all first-line patients – n = 78 – was 44.9%. Twenty-two DetermaIO– tumors had a 23% response rate (5 partial responses) whereas of the 56 DetermaIO+ patients, the response rate was 54% (2 complete response and 28 partial responses).”

A score on the test, he said, was not associated with OS or PFS in patients who received second-line or later treatment.

The study was not designed to evaluate the predictive power of the test. “For a biomarker to be defined as predictive requires a formal test of interaction between a treatment group (ICI monotherapy, for example) vs. a control group (chemo-only or other regimen),” Dr. Varga explained. “In our analysis, there was no group of patients who did not receive ICI monotherapy. Thus a test for interaction and a predictive claim cannot be made.”

The test is available for at no cost via an early access program, Dr. Varga said, and Oncocyte is getting ready to seek Medicare coverage. The ultimate cost of the test, he said, is unknown.

Oncocyte funded this study. Dr. Varga and several other study authors are Oncocyte employees, and another author is a paid consultant to the company.

A 27-gene immuno-oncology assay appears to provide useful information about whether patients with advanced non–small cell lung cancer (NSCLC) could benefit from immune checkpoint inhibitor (ICI) therapy despite their poor status, researchers reported.

Positive findings on the test, known as DetermaIO, were “associated with efficacy of response to ICI therapy in advanced NSCLC patients,” Matthew G. Varga, PhD, manager of scientific affairs at Oncocyte, said in an interview. “These data suggest that DetermaIO warrants further study in poor performance status patients as it has the potential to identify likely responders to ICI therapy.”

Oncocyte, which is developing the test, presented the findings in a poster at the annual meeting of the Society for Immunotherapy of Cancer.

According to Dr. Varga, “DetermaIO is an RT-qPCR test that can be applied to FFPE [formalin-fixed, paraffin-embedded] tissue specimens to quantify the relative gene expression of 27 genes and subsequently applies our proprietary algorithm to generate an IO score based on the gene expression profile. The DetermaIO score is a binary IO+ or IO– score, representing likely responder or nonresponder, respectively.”

The test was originally developed for triple negative breast cancer, Dr. Varga said, and it’s been validated in non–small cell lung cancer, metastatic urothelial carcinoma, and metastatic colorectal carcinoma.

For the study, the researchers retrospectively tracked associations between DetermaIO score and either progression-free survival (PFS) or overall survival (OS) in 147 patients in Canada with NSCLC who were treated with ICI monotherapy. All had programmed death-ligand 1 (PD-L1) ≥ 50%.

Overall, outcomes were poor: The median survival was 12.7 months, and median PFS was 7.0 months. These outcomes were even worse in those who underwent therapy as a second- line treatment: The median survival was 9.7 months, and median PFS was 4.4 months.

“DetermaIO was significantly associated with PFS at hazard ratio [HR] = 0.55, 95% [confidence interval] CI, 0.32-0.94, P = .028. In our analyses, a hazard ratio less than 1 suggests lower risk – i.e, that DetermaIO+ patients have lower risk of an event – death or progression – compared to a DetermaIO– patient,” Dr. Varga said. “The association for overall survival was not statistically significant, but it was suggestive of clinically meaningful benefit.”

He added that “we could identify likely responders from nonresponders, suggesting that the DetermaIO score adds both independent and incremental data to the existing gold standard biomarker. The objective response rate for all first-line patients – n = 78 – was 44.9%. Twenty-two DetermaIO– tumors had a 23% response rate (5 partial responses) whereas of the 56 DetermaIO+ patients, the response rate was 54% (2 complete response and 28 partial responses).”

A score on the test, he said, was not associated with OS or PFS in patients who received second-line or later treatment.

The study was not designed to evaluate the predictive power of the test. “For a biomarker to be defined as predictive requires a formal test of interaction between a treatment group (ICI monotherapy, for example) vs. a control group (chemo-only or other regimen),” Dr. Varga explained. “In our analysis, there was no group of patients who did not receive ICI monotherapy. Thus a test for interaction and a predictive claim cannot be made.”

The test is available for at no cost via an early access program, Dr. Varga said, and Oncocyte is getting ready to seek Medicare coverage. The ultimate cost of the test, he said, is unknown.

Oncocyte funded this study. Dr. Varga and several other study authors are Oncocyte employees, and another author is a paid consultant to the company.