Cardiology News

The introduction of hemoglobin A1c as an option for diagnosing type 2 diabetes over a decade ago may have resulted in underdiagnosis, new research indicates.

In 2011, the World Health Organization advised that A1c measurement, with a cutoff value of 6.5%, could be used to diagnose diabetes. The American Diabetes Association had issued similar guidance in 2010.

Prior to that time, the less-convenient 2-hour oral glucose tolerance test (OGTT) and fasting blood glucose (FBG) were the only recommended tests. While WHO made no recommendations for interpreting values below 6.5%, the ADA designated 5.7%-6.4% as prediabetes.

The new study, published online in The Lancet Regional Health–Europe, showed that the incidence of type 2 diabetes in Denmark had been increasing prior to the 2012 adoption of A1c as a diagnostic option but declined thereafter. And all-cause mortality among people with type 2 diabetes, which had been dropping, began to increase after that time.  

“Our findings suggest that fewer patients have been diagnosed with [type 2 diabetes] since A1c testing was introduced as a convenient diagnostic option. We may thus be missing a group with borderline increased A1c values that is still at high metabolic and cardiovascular risk,” Jakob S. Knudsen, MD, of the department of clinical epidemiology, Aarhus (Denmark) University Hospital, and colleagues wrote.

Therefore, Dr. Knudsen said in an interview, clinicians should “consider testing with FBG or OGTT when presented with borderline A1c values.”

The reason for the increase in mortality after incident type 2 diabetes diagnosis, he said, “is that the patients who would have reduced the average mortality are no longer diagnosed...This does not reflect that we are treating already diagnosed patients any worse, rather some patients are not diagnosed.”

But M. Sue Kirkman, MD, emeritus professor of medicine at the University of North Carolina at Chapel Hill, who was part of the writing group for the 2010 ADA guidelines, isn’t convinced.

“This is an interesting paper, but it is a bit hard to believe that a change in WHO recommendations would have such a large and almost immediate impact on incidence and mortality. It seems likely that ... factors [other] than just the changes in recommendations for the diagnostic test account for these findings,” she said.

Dr. Kirkman pointed to new data just out from the Centers for Disease Control and Prevention on Jan. 26 that don›t show evidence of a higher proportion of people in the United States who have undiagnosed diabetes, “which would be expected if more cases were being ‘missed’ by A1c.”

She added that the CDC incidence data “show a continuing steady rate of decline in incidence that began in 2008, before any organizations recommended using A1c to screen for or diagnose diabetes.” Moreover, “there is evidence that type 2 diabetes incidence has fallen or plateaued in many countries since 2006, well before the WHO recommendation, with most of the studies from developed countries.”

But Dr. Knudsen also cited other data, including a study that showed a drop or stabilization in diagnosed diabetes incidence in high-income countries since 2010.

“That study concluded that the reasons for the declines in the incidence of diagnosed diabetes warrant further investigation with appropriate data sources, which was a main objective of our study,” wrote Dr. Knudsen and coauthors.

Dr. Knudsen said in an interview: “We are not the first to make the point that this sudden change is related to A1c introduction...but we are the first to have the data to clearly show that is the case.”

Diabetes incidence dropped but mortality rose after 2010

The population-based longitudinal study used four Danish medical databases and included 415,553 patients treated for type 2 diabetes for the first time from 1995-2018 and 2,060,279 matched comparators not treated for diabetes.

From 1995 until the 2012 introduction of A1c as a diagnostic option, the annual standardized incidence rates of type 2 diabetes more than doubled, from 193 per 100,000 population to 396 per 100,000 population, at a rate of 4.1% per year.

But from 2011 to 2018, the annual standardized incidence rate declined by 36%, to 253 per 100,000 population, a 5.7% annualized decrease.

The increase prior to 2011 occurred in both men and women and in all age groups, while the subsequent decline was seen primarily in the older age groups. The all-cause mortality risk within the first year after diabetes diagnosis was higher than subsequent 1-year mortality risks and not different between men and women.

From the periods 1995-1997 to 2010-2012, the adjusted mortality rate among those with type 2 diabetes decreased by 44%, from 72 deaths per 1000 person-years to 40 deaths per 1000 person-years (adjusted mortality rate ratio, 0.55). After that low level in 2010-2012, mortality increased by 27% to 48 per 1000 person-years (adjusted mortality rate ratio 0.69, compared with 1995-1997).  

The reversed mortality trend after 2010-2012 was caused almost entirely by the increase in the first year after diabetes diagnosis, Dr. Knudsen and colleagues noted.

According to Dr. Kirkman, “A1c is strongly predictive of complications and mortality. That plus its ease of use and the fact that more people may be screened mean it’s still a good option. But for any of these tests, people who are slightly below the cut-point should not be considered normal or low risk.”

Indeed, Dr. Knudsen and colleagues said, “these findings may have implications for clinical practice and suggest that a more multifactorial view of metabolic risk is needed.”

Dr. Knudsen and Dr. Kirkman have reported no relevant financial relationships.

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

The introduction of hemoglobin A1c as an option for diagnosing type 2 diabetes over a decade ago may have resulted in underdiagnosis, new research indicates.

In 2011, the World Health Organization advised that A1c measurement, with a cutoff value of 6.5%, could be used to diagnose diabetes. The American Diabetes Association had issued similar guidance in 2010.

Prior to that time, the less-convenient 2-hour oral glucose tolerance test (OGTT) and fasting blood glucose (FBG) were the only recommended tests. While WHO made no recommendations for interpreting values below 6.5%, the ADA designated 5.7%-6.4% as prediabetes.

The new study, published online in The Lancet Regional Health–Europe, showed that the incidence of type 2 diabetes in Denmark had been increasing prior to the 2012 adoption of A1c as a diagnostic option but declined thereafter. And all-cause mortality among people with type 2 diabetes, which had been dropping, began to increase after that time.  

“Our findings suggest that fewer patients have been diagnosed with [type 2 diabetes] since A1c testing was introduced as a convenient diagnostic option. We may thus be missing a group with borderline increased A1c values that is still at high metabolic and cardiovascular risk,” Jakob S. Knudsen, MD, of the department of clinical epidemiology, Aarhus (Denmark) University Hospital, and colleagues wrote.

Therefore, Dr. Knudsen said in an interview, clinicians should “consider testing with FBG or OGTT when presented with borderline A1c values.”

The reason for the increase in mortality after incident type 2 diabetes diagnosis, he said, “is that the patients who would have reduced the average mortality are no longer diagnosed...This does not reflect that we are treating already diagnosed patients any worse, rather some patients are not diagnosed.”

But M. Sue Kirkman, MD, emeritus professor of medicine at the University of North Carolina at Chapel Hill, who was part of the writing group for the 2010 ADA guidelines, isn’t convinced.

“This is an interesting paper, but it is a bit hard to believe that a change in WHO recommendations would have such a large and almost immediate impact on incidence and mortality. It seems likely that ... factors [other] than just the changes in recommendations for the diagnostic test account for these findings,” she said.

Dr. Kirkman pointed to new data just out from the Centers for Disease Control and Prevention on Jan. 26 that don›t show evidence of a higher proportion of people in the United States who have undiagnosed diabetes, “which would be expected if more cases were being ‘missed’ by A1c.”

She added that the CDC incidence data “show a continuing steady rate of decline in incidence that began in 2008, before any organizations recommended using A1c to screen for or diagnose diabetes.” Moreover, “there is evidence that type 2 diabetes incidence has fallen or plateaued in many countries since 2006, well before the WHO recommendation, with most of the studies from developed countries.”

But Dr. Knudsen also cited other data, including a study that showed a drop or stabilization in diagnosed diabetes incidence in high-income countries since 2010.

“That study concluded that the reasons for the declines in the incidence of diagnosed diabetes warrant further investigation with appropriate data sources, which was a main objective of our study,” wrote Dr. Knudsen and coauthors.

Dr. Knudsen said in an interview: “We are not the first to make the point that this sudden change is related to A1c introduction...but we are the first to have the data to clearly show that is the case.”

Diabetes incidence dropped but mortality rose after 2010

The population-based longitudinal study used four Danish medical databases and included 415,553 patients treated for type 2 diabetes for the first time from 1995-2018 and 2,060,279 matched comparators not treated for diabetes.

From 1995 until the 2012 introduction of A1c as a diagnostic option, the annual standardized incidence rates of type 2 diabetes more than doubled, from 193 per 100,000 population to 396 per 100,000 population, at a rate of 4.1% per year.

But from 2011 to 2018, the annual standardized incidence rate declined by 36%, to 253 per 100,000 population, a 5.7% annualized decrease.

The increase prior to 2011 occurred in both men and women and in all age groups, while the subsequent decline was seen primarily in the older age groups. The all-cause mortality risk within the first year after diabetes diagnosis was higher than subsequent 1-year mortality risks and not different between men and women.

From the periods 1995-1997 to 2010-2012, the adjusted mortality rate among those with type 2 diabetes decreased by 44%, from 72 deaths per 1000 person-years to 40 deaths per 1000 person-years (adjusted mortality rate ratio, 0.55). After that low level in 2010-2012, mortality increased by 27% to 48 per 1000 person-years (adjusted mortality rate ratio 0.69, compared with 1995-1997).  

The reversed mortality trend after 2010-2012 was caused almost entirely by the increase in the first year after diabetes diagnosis, Dr. Knudsen and colleagues noted.

According to Dr. Kirkman, “A1c is strongly predictive of complications and mortality. That plus its ease of use and the fact that more people may be screened mean it’s still a good option. But for any of these tests, people who are slightly below the cut-point should not be considered normal or low risk.”

Indeed, Dr. Knudsen and colleagues said, “these findings may have implications for clinical practice and suggest that a more multifactorial view of metabolic risk is needed.”

Dr. Knudsen and Dr. Kirkman have reported no relevant financial relationships.

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

The introduction of hemoglobin A1c as an option for diagnosing type 2 diabetes over a decade ago may have resulted in underdiagnosis, new research indicates.

In 2011, the World Health Organization advised that A1c measurement, with a cutoff value of 6.5%, could be used to diagnose diabetes. The American Diabetes Association had issued similar guidance in 2010.

Prior to that time, the less-convenient 2-hour oral glucose tolerance test (OGTT) and fasting blood glucose (FBG) were the only recommended tests. While WHO made no recommendations for interpreting values below 6.5%, the ADA designated 5.7%-6.4% as prediabetes.

The new study, published online in The Lancet Regional Health–Europe, showed that the incidence of type 2 diabetes in Denmark had been increasing prior to the 2012 adoption of A1c as a diagnostic option but declined thereafter. And all-cause mortality among people with type 2 diabetes, which had been dropping, began to increase after that time.  

“Our findings suggest that fewer patients have been diagnosed with [type 2 diabetes] since A1c testing was introduced as a convenient diagnostic option. We may thus be missing a group with borderline increased A1c values that is still at high metabolic and cardiovascular risk,” Jakob S. Knudsen, MD, of the department of clinical epidemiology, Aarhus (Denmark) University Hospital, and colleagues wrote.

Therefore, Dr. Knudsen said in an interview, clinicians should “consider testing with FBG or OGTT when presented with borderline A1c values.”

The reason for the increase in mortality after incident type 2 diabetes diagnosis, he said, “is that the patients who would have reduced the average mortality are no longer diagnosed...This does not reflect that we are treating already diagnosed patients any worse, rather some patients are not diagnosed.”

But M. Sue Kirkman, MD, emeritus professor of medicine at the University of North Carolina at Chapel Hill, who was part of the writing group for the 2010 ADA guidelines, isn’t convinced.

“This is an interesting paper, but it is a bit hard to believe that a change in WHO recommendations would have such a large and almost immediate impact on incidence and mortality. It seems likely that ... factors [other] than just the changes in recommendations for the diagnostic test account for these findings,” she said.

Dr. Kirkman pointed to new data just out from the Centers for Disease Control and Prevention on Jan. 26 that don›t show evidence of a higher proportion of people in the United States who have undiagnosed diabetes, “which would be expected if more cases were being ‘missed’ by A1c.”

She added that the CDC incidence data “show a continuing steady rate of decline in incidence that began in 2008, before any organizations recommended using A1c to screen for or diagnose diabetes.” Moreover, “there is evidence that type 2 diabetes incidence has fallen or plateaued in many countries since 2006, well before the WHO recommendation, with most of the studies from developed countries.”

But Dr. Knudsen also cited other data, including a study that showed a drop or stabilization in diagnosed diabetes incidence in high-income countries since 2010.

“That study concluded that the reasons for the declines in the incidence of diagnosed diabetes warrant further investigation with appropriate data sources, which was a main objective of our study,” wrote Dr. Knudsen and coauthors.

Dr. Knudsen said in an interview: “We are not the first to make the point that this sudden change is related to A1c introduction...but we are the first to have the data to clearly show that is the case.”

Diabetes incidence dropped but mortality rose after 2010

The population-based longitudinal study used four Danish medical databases and included 415,553 patients treated for type 2 diabetes for the first time from 1995-2018 and 2,060,279 matched comparators not treated for diabetes.

From 1995 until the 2012 introduction of A1c as a diagnostic option, the annual standardized incidence rates of type 2 diabetes more than doubled, from 193 per 100,000 population to 396 per 100,000 population, at a rate of 4.1% per year.

But from 2011 to 2018, the annual standardized incidence rate declined by 36%, to 253 per 100,000 population, a 5.7% annualized decrease.

The increase prior to 2011 occurred in both men and women and in all age groups, while the subsequent decline was seen primarily in the older age groups. The all-cause mortality risk within the first year after diabetes diagnosis was higher than subsequent 1-year mortality risks and not different between men and women.

From the periods 1995-1997 to 2010-2012, the adjusted mortality rate among those with type 2 diabetes decreased by 44%, from 72 deaths per 1000 person-years to 40 deaths per 1000 person-years (adjusted mortality rate ratio, 0.55). After that low level in 2010-2012, mortality increased by 27% to 48 per 1000 person-years (adjusted mortality rate ratio 0.69, compared with 1995-1997).  

The reversed mortality trend after 2010-2012 was caused almost entirely by the increase in the first year after diabetes diagnosis, Dr. Knudsen and colleagues noted.

According to Dr. Kirkman, “A1c is strongly predictive of complications and mortality. That plus its ease of use and the fact that more people may be screened mean it’s still a good option. But for any of these tests, people who are slightly below the cut-point should not be considered normal or low risk.”

Indeed, Dr. Knudsen and colleagues said, “these findings may have implications for clinical practice and suggest that a more multifactorial view of metabolic risk is needed.”

Dr. Knudsen and Dr. Kirkman have reported no relevant financial relationships.

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

Right now, more than 106,600 people in the United States are on the national transplant waiting list, each hoping to hear soon that a lung, kidney, heart, or other vital organ has been found for them. It’s the promise not just of a new organ, but a new life.

Well before they are placed on that list, transplant candidates, as they’re known, are evaluated with a battery of tests and exams to be sure they are infection free, their other organs are healthy, and that all their vaccinations are up to date.

Now, COVID vaccinations – and some people’s resistance to them – have turned what used to be routine preparation controversial.

In January, a 31-year-old Boston father of two declined to get the COVID-19 vaccine, and Brigham and Women’s Hospital officials removed him from the heart transplant waiting list. And in North Carolina, a 38-year-old man in need of a kidney transplant said he, too, was denied the organ when he declined to get the vaccination.

Those are just two of the most recent cases. The decisions by the transplant centers to remove the candidates from the waiting list have set off a national debate among ethicists, family members, doctors, patients, and others.

On social media and in conversation, the question persists: Is removing them from the list unfair and cruel, or simply business as usual to keep the patient as healthy as possible and the transplant as successful as possible?

Two recent tweets sum up the debate.

“The people responsible for this should be charged with attempted homicide,” one Twitter user said, while another suggested that the more accurate way to headline the news about a transplant candidate refusing the COVID-19 vaccine would be: “Patient voluntarily forfeits donor organ.”

Doctors and ethics experts, as well as other patients on the waiting list, say it’s simply good medicine to require the COVID vaccine, along with a host of other pretransplant requirements.
 

Transplant protocols

“Transplant medicine has always been a strong promoter of vaccination,” said Silas Prescod Norman, MD, a clinical associate professor of nephrology and internal medicine at the University of Michigan, Ann Arbor. He is a kidney specialist who works in the university’s transplant clinic.

Requiring the COVID vaccine is in line with requirements to get numerous other vaccines, he said.“Promoting the COVID vaccine among our transplant candidates and recipients is just an extension of our usual practice.

“In transplantation, first and foremost is patient safety,” Dr. Norman said. “And we know that solid organ transplant patients are at substantially higher risk of contracting COVID than nontransplant patients.”

After the transplant, they are placed on immunosuppressant drugs, that weaken the immune system while also decreasing the body’s ability to reject the new organ.

“We know now, because there is good data about the vaccine to show that people who are on transplant medications are less likely to make detectable antibodies after vaccination,” said Dr. Norman, who’s also a medical adviser for the American Kidney Fund, a nonprofit that provides kidney health information and financial assistance for dialysis.

And this is not a surprise because of the immunosuppressive effects, he said. “So it only makes sense to get people vaccinated before transplantation.”

Researchers compared the cases of more than 17,000 people who had received organ transplants and were hospitalized from April to November 2020, either for COVID (1,682 of them) or other health issues. Those who had COVID were more likely to have complications and to die in the hospital than those who did not have it.
 

Vaccination guidelines, policies

Federal COVID-19 treatment guidelines from the National Institutes of Health state that transplant patients on immunosuppressant drugs used after the procedure should be considered at a higher risk of getting severe COVID if infected.

In a joint statement from the American Society of Transplant Surgeons, the American Society of Transplantation, and the International Society for Heart and Lung Transplantation, the organizations say they “strongly recommend that all eligible children and adult transplant candidates and recipients be vaccinated with a COVID-19 vaccine [and booster] that is approved or authorized in their jurisdiction. Whenever possible, vaccination should occur prior to transplantation.” Ideally, it should be completed at least 2 weeks before the transplant.

The organizations also “support the development of institutional policies regarding pretransplant vaccination. We believe that this is in the best interest of the transplant candidate, optimizing their chances of getting through the perioperative and posttransplant periods without severe COVID-19 disease, especially at times of greater infection prevalence.”

Officials at Brigham and Women’s Hospital, where the 31-year-old father was removed from the list, issued a statement that reads, in part: “Our Mass General Brigham health care system requires several [Centers for Disease Control and Prevention]-recommended vaccines, including the COVID-19 vaccine, and lifestyle behaviors for transplant candidates to create both the best chance for a successful operation and to optimize the patient’s survival after transplantation, given that their immune system is drastically suppressed. Patients are not active on the wait list without this.”
 

Ethics amid organ shortage

“Organs are scarce,” said Arthur L. Caplan, PhD, director of the division of medical ethics at New York University Langone Medical Center. That makes the goal of choosing the very best candidates for success even more crucial.

“You try to maximize the chance the organ will work,” he said. Pretransplant vaccination is one way.

The shortage is most severe for kidney transplants. In 2020, according to federal statistics, more than 91,000 kidney transplants were needed, but fewer than 23,000 were received. During 2021, 41,354 transplants were done, an increase of nearly 6% over the previous year. The total includes kidneys, hearts, lungs, and other organs, with kidneys accounting for more than 24,000 of the total.

Even with the rise in transplant numbers, supply does not meet demand. According to federal statistics, 17 people in the United States die each day waiting for an organ transplant. Every 9 minutes, someone is added to the waiting list.

“This isn’t and it shouldn’t be a fight about the COVID vaccine,” Dr. Caplan said. “This isn’t an issue about punishing non-COVID vaccinators. It’s deciding who is going to get a scarce organ.”

“A lot of people [opposed to removing the nonvaccinated from the list] think: ‘Oh, they are just killing those people who won’t take a COVID vaccine.’ That’s not what is going on.”

The transplant candidate must be in the best possible shape overall, Dr. Caplan and doctors agreed. Someone who is smoking, drinking heavily, or abusing drugs isn’t going to the top of the list either. And for other procedures, such as bariatric surgery or knee surgery, some patients are told first to lose weight before a surgeon will operate.

The worry about side effects from the vaccine, which some patients have cited as a concern, is misplaced, Dr. Caplan said. What transplant candidates who refuse the COVID vaccine may not be thinking about is that they are facing a serious operation and will be on numerous anti-rejection drugs, with side effects, after the surgery.

“So to be worried about the side effects of a COVID vaccine is irrational,” he said.
 

Transplants: The process

The patients who were recently removed from the transplant list could seek care and a transplant at an alternate center, said Anne Paschke, a spokesperson for the United Network for Organ Sharing, a nonprofit group that is under contract with the federal government and operates the national Organ Procurement and Transplantation Network (OPTN).

“Transplant hospitals decide which patients to add to the wait list based on their own criteria and medical judgment to create the best chance for a positive transplant outcome,” she said. That’s done with the understanding that patients will help with their medical care.

So, if one program won’t accept a patient, another may. But, if a patient turned down at one center due to refusing to get the COVID vaccine tries another center, the requirements at that hospital may be the same, she said.

OPTN maintains a list of transplant centers. As of Jan. 28, there were 251 transplant centers, according to UNOS, which manages the waiting list, matches donors and recipients, and strives for equity, among other duties.
 

Pretransplant refusers not typical

“The cases we are seeing are outliers,” Dr. Caplan said of the handful of known candidates who have refused the vaccine. Most ask their doctor exactly what they need to do to live and follow those instructions.

Dr. Norman agreed. Most of the kidney patients he cares for who are hoping for a transplant have been on dialysis, “which they do not like. They are doing whatever they can to make sure they don’t go back on dialysis. As a group, they tend to be very adherent, very safety conscious because they understand their risk and they understand the gift they have received [or will receive] through transplantation. They want to do everything they can to respect and protect that gift.”

Not surprisingly, some on the transplant list who are vaccinated have strong opinions about those who refuse to get the vaccine. Dana J. Ufkes, 61, a Seattle realtor, has been on the kidney transplant list – this time – since 2003, hoping for her third transplant. When asked if potential recipients should be removed from the list if they refuse the COVID vaccine, her answer was immediate: “Absolutely.”

At age 17, Ms. Ufkes got a serious kidney infection that went undiagnosed and untreated. Her kidney health worsened, and she needed a transplant. She got her first one in 1986, then again in 1992.

“They last longer than they used to,” she said. But not forever. (According to the American Kidney Fund, transplants from a living kidney donor last about 15-20 years; from a deceased donor, 10-15.)

The decision to decline the vaccine is, of course, each person’s choice, Ms. Ufkes said. But “if they don’t want to be vaccinated [and still want to be on the list], I think that’s BS.”

Citing the lack of organs, “it’s not like they are handing these out like jellybeans.”

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

Right now, more than 106,600 people in the United States are on the national transplant waiting list, each hoping to hear soon that a lung, kidney, heart, or other vital organ has been found for them. It’s the promise not just of a new organ, but a new life.

Well before they are placed on that list, transplant candidates, as they’re known, are evaluated with a battery of tests and exams to be sure they are infection free, their other organs are healthy, and that all their vaccinations are up to date.

Now, COVID vaccinations – and some people’s resistance to them – have turned what used to be routine preparation controversial.

In January, a 31-year-old Boston father of two declined to get the COVID-19 vaccine, and Brigham and Women’s Hospital officials removed him from the heart transplant waiting list. And in North Carolina, a 38-year-old man in need of a kidney transplant said he, too, was denied the organ when he declined to get the vaccination.

Those are just two of the most recent cases. The decisions by the transplant centers to remove the candidates from the waiting list have set off a national debate among ethicists, family members, doctors, patients, and others.

On social media and in conversation, the question persists: Is removing them from the list unfair and cruel, or simply business as usual to keep the patient as healthy as possible and the transplant as successful as possible?

Two recent tweets sum up the debate.

“The people responsible for this should be charged with attempted homicide,” one Twitter user said, while another suggested that the more accurate way to headline the news about a transplant candidate refusing the COVID-19 vaccine would be: “Patient voluntarily forfeits donor organ.”

Doctors and ethics experts, as well as other patients on the waiting list, say it’s simply good medicine to require the COVID vaccine, along with a host of other pretransplant requirements.
 

Transplant protocols

“Transplant medicine has always been a strong promoter of vaccination,” said Silas Prescod Norman, MD, a clinical associate professor of nephrology and internal medicine at the University of Michigan, Ann Arbor. He is a kidney specialist who works in the university’s transplant clinic.

Requiring the COVID vaccine is in line with requirements to get numerous other vaccines, he said.“Promoting the COVID vaccine among our transplant candidates and recipients is just an extension of our usual practice.

“In transplantation, first and foremost is patient safety,” Dr. Norman said. “And we know that solid organ transplant patients are at substantially higher risk of contracting COVID than nontransplant patients.”

After the transplant, they are placed on immunosuppressant drugs, that weaken the immune system while also decreasing the body’s ability to reject the new organ.

“We know now, because there is good data about the vaccine to show that people who are on transplant medications are less likely to make detectable antibodies after vaccination,” said Dr. Norman, who’s also a medical adviser for the American Kidney Fund, a nonprofit that provides kidney health information and financial assistance for dialysis.

And this is not a surprise because of the immunosuppressive effects, he said. “So it only makes sense to get people vaccinated before transplantation.”

Researchers compared the cases of more than 17,000 people who had received organ transplants and were hospitalized from April to November 2020, either for COVID (1,682 of them) or other health issues. Those who had COVID were more likely to have complications and to die in the hospital than those who did not have it.
 

Vaccination guidelines, policies

Federal COVID-19 treatment guidelines from the National Institutes of Health state that transplant patients on immunosuppressant drugs used after the procedure should be considered at a higher risk of getting severe COVID if infected.

In a joint statement from the American Society of Transplant Surgeons, the American Society of Transplantation, and the International Society for Heart and Lung Transplantation, the organizations say they “strongly recommend that all eligible children and adult transplant candidates and recipients be vaccinated with a COVID-19 vaccine [and booster] that is approved or authorized in their jurisdiction. Whenever possible, vaccination should occur prior to transplantation.” Ideally, it should be completed at least 2 weeks before the transplant.

The organizations also “support the development of institutional policies regarding pretransplant vaccination. We believe that this is in the best interest of the transplant candidate, optimizing their chances of getting through the perioperative and posttransplant periods without severe COVID-19 disease, especially at times of greater infection prevalence.”

Officials at Brigham and Women’s Hospital, where the 31-year-old father was removed from the list, issued a statement that reads, in part: “Our Mass General Brigham health care system requires several [Centers for Disease Control and Prevention]-recommended vaccines, including the COVID-19 vaccine, and lifestyle behaviors for transplant candidates to create both the best chance for a successful operation and to optimize the patient’s survival after transplantation, given that their immune system is drastically suppressed. Patients are not active on the wait list without this.”
 

Ethics amid organ shortage

“Organs are scarce,” said Arthur L. Caplan, PhD, director of the division of medical ethics at New York University Langone Medical Center. That makes the goal of choosing the very best candidates for success even more crucial.

“You try to maximize the chance the organ will work,” he said. Pretransplant vaccination is one way.

The shortage is most severe for kidney transplants. In 2020, according to federal statistics, more than 91,000 kidney transplants were needed, but fewer than 23,000 were received. During 2021, 41,354 transplants were done, an increase of nearly 6% over the previous year. The total includes kidneys, hearts, lungs, and other organs, with kidneys accounting for more than 24,000 of the total.

Even with the rise in transplant numbers, supply does not meet demand. According to federal statistics, 17 people in the United States die each day waiting for an organ transplant. Every 9 minutes, someone is added to the waiting list.

“This isn’t and it shouldn’t be a fight about the COVID vaccine,” Dr. Caplan said. “This isn’t an issue about punishing non-COVID vaccinators. It’s deciding who is going to get a scarce organ.”

“A lot of people [opposed to removing the nonvaccinated from the list] think: ‘Oh, they are just killing those people who won’t take a COVID vaccine.’ That’s not what is going on.”

The transplant candidate must be in the best possible shape overall, Dr. Caplan and doctors agreed. Someone who is smoking, drinking heavily, or abusing drugs isn’t going to the top of the list either. And for other procedures, such as bariatric surgery or knee surgery, some patients are told first to lose weight before a surgeon will operate.

The worry about side effects from the vaccine, which some patients have cited as a concern, is misplaced, Dr. Caplan said. What transplant candidates who refuse the COVID vaccine may not be thinking about is that they are facing a serious operation and will be on numerous anti-rejection drugs, with side effects, after the surgery.

“So to be worried about the side effects of a COVID vaccine is irrational,” he said.
 

Transplants: The process

The patients who were recently removed from the transplant list could seek care and a transplant at an alternate center, said Anne Paschke, a spokesperson for the United Network for Organ Sharing, a nonprofit group that is under contract with the federal government and operates the national Organ Procurement and Transplantation Network (OPTN).

“Transplant hospitals decide which patients to add to the wait list based on their own criteria and medical judgment to create the best chance for a positive transplant outcome,” she said. That’s done with the understanding that patients will help with their medical care.

So, if one program won’t accept a patient, another may. But, if a patient turned down at one center due to refusing to get the COVID vaccine tries another center, the requirements at that hospital may be the same, she said.

OPTN maintains a list of transplant centers. As of Jan. 28, there were 251 transplant centers, according to UNOS, which manages the waiting list, matches donors and recipients, and strives for equity, among other duties.
 

Pretransplant refusers not typical

“The cases we are seeing are outliers,” Dr. Caplan said of the handful of known candidates who have refused the vaccine. Most ask their doctor exactly what they need to do to live and follow those instructions.

Dr. Norman agreed. Most of the kidney patients he cares for who are hoping for a transplant have been on dialysis, “which they do not like. They are doing whatever they can to make sure they don’t go back on dialysis. As a group, they tend to be very adherent, very safety conscious because they understand their risk and they understand the gift they have received [or will receive] through transplantation. They want to do everything they can to respect and protect that gift.”

Not surprisingly, some on the transplant list who are vaccinated have strong opinions about those who refuse to get the vaccine. Dana J. Ufkes, 61, a Seattle realtor, has been on the kidney transplant list – this time – since 2003, hoping for her third transplant. When asked if potential recipients should be removed from the list if they refuse the COVID vaccine, her answer was immediate: “Absolutely.”

At age 17, Ms. Ufkes got a serious kidney infection that went undiagnosed and untreated. Her kidney health worsened, and she needed a transplant. She got her first one in 1986, then again in 1992.

“They last longer than they used to,” she said. But not forever. (According to the American Kidney Fund, transplants from a living kidney donor last about 15-20 years; from a deceased donor, 10-15.)

The decision to decline the vaccine is, of course, each person’s choice, Ms. Ufkes said. But “if they don’t want to be vaccinated [and still want to be on the list], I think that’s BS.”

Citing the lack of organs, “it’s not like they are handing these out like jellybeans.”

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

Right now, more than 106,600 people in the United States are on the national transplant waiting list, each hoping to hear soon that a lung, kidney, heart, or other vital organ has been found for them. It’s the promise not just of a new organ, but a new life.

Well before they are placed on that list, transplant candidates, as they’re known, are evaluated with a battery of tests and exams to be sure they are infection free, their other organs are healthy, and that all their vaccinations are up to date.

Now, COVID vaccinations – and some people’s resistance to them – have turned what used to be routine preparation controversial.

In January, a 31-year-old Boston father of two declined to get the COVID-19 vaccine, and Brigham and Women’s Hospital officials removed him from the heart transplant waiting list. And in North Carolina, a 38-year-old man in need of a kidney transplant said he, too, was denied the organ when he declined to get the vaccination.

Those are just two of the most recent cases. The decisions by the transplant centers to remove the candidates from the waiting list have set off a national debate among ethicists, family members, doctors, patients, and others.

On social media and in conversation, the question persists: Is removing them from the list unfair and cruel, or simply business as usual to keep the patient as healthy as possible and the transplant as successful as possible?

Two recent tweets sum up the debate.

“The people responsible for this should be charged with attempted homicide,” one Twitter user said, while another suggested that the more accurate way to headline the news about a transplant candidate refusing the COVID-19 vaccine would be: “Patient voluntarily forfeits donor organ.”

Doctors and ethics experts, as well as other patients on the waiting list, say it’s simply good medicine to require the COVID vaccine, along with a host of other pretransplant requirements.
 

Transplant protocols

“Transplant medicine has always been a strong promoter of vaccination,” said Silas Prescod Norman, MD, a clinical associate professor of nephrology and internal medicine at the University of Michigan, Ann Arbor. He is a kidney specialist who works in the university’s transplant clinic.

Requiring the COVID vaccine is in line with requirements to get numerous other vaccines, he said.“Promoting the COVID vaccine among our transplant candidates and recipients is just an extension of our usual practice.

“In transplantation, first and foremost is patient safety,” Dr. Norman said. “And we know that solid organ transplant patients are at substantially higher risk of contracting COVID than nontransplant patients.”

After the transplant, they are placed on immunosuppressant drugs, that weaken the immune system while also decreasing the body’s ability to reject the new organ.

“We know now, because there is good data about the vaccine to show that people who are on transplant medications are less likely to make detectable antibodies after vaccination,” said Dr. Norman, who’s also a medical adviser for the American Kidney Fund, a nonprofit that provides kidney health information and financial assistance for dialysis.

And this is not a surprise because of the immunosuppressive effects, he said. “So it only makes sense to get people vaccinated before transplantation.”

Researchers compared the cases of more than 17,000 people who had received organ transplants and were hospitalized from April to November 2020, either for COVID (1,682 of them) or other health issues. Those who had COVID were more likely to have complications and to die in the hospital than those who did not have it.
 

Vaccination guidelines, policies

Federal COVID-19 treatment guidelines from the National Institutes of Health state that transplant patients on immunosuppressant drugs used after the procedure should be considered at a higher risk of getting severe COVID if infected.

In a joint statement from the American Society of Transplant Surgeons, the American Society of Transplantation, and the International Society for Heart and Lung Transplantation, the organizations say they “strongly recommend that all eligible children and adult transplant candidates and recipients be vaccinated with a COVID-19 vaccine [and booster] that is approved or authorized in their jurisdiction. Whenever possible, vaccination should occur prior to transplantation.” Ideally, it should be completed at least 2 weeks before the transplant.

The organizations also “support the development of institutional policies regarding pretransplant vaccination. We believe that this is in the best interest of the transplant candidate, optimizing their chances of getting through the perioperative and posttransplant periods without severe COVID-19 disease, especially at times of greater infection prevalence.”

Officials at Brigham and Women’s Hospital, where the 31-year-old father was removed from the list, issued a statement that reads, in part: “Our Mass General Brigham health care system requires several [Centers for Disease Control and Prevention]-recommended vaccines, including the COVID-19 vaccine, and lifestyle behaviors for transplant candidates to create both the best chance for a successful operation and to optimize the patient’s survival after transplantation, given that their immune system is drastically suppressed. Patients are not active on the wait list without this.”
 

Ethics amid organ shortage

“Organs are scarce,” said Arthur L. Caplan, PhD, director of the division of medical ethics at New York University Langone Medical Center. That makes the goal of choosing the very best candidates for success even more crucial.

“You try to maximize the chance the organ will work,” he said. Pretransplant vaccination is one way.

The shortage is most severe for kidney transplants. In 2020, according to federal statistics, more than 91,000 kidney transplants were needed, but fewer than 23,000 were received. During 2021, 41,354 transplants were done, an increase of nearly 6% over the previous year. The total includes kidneys, hearts, lungs, and other organs, with kidneys accounting for more than 24,000 of the total.

Even with the rise in transplant numbers, supply does not meet demand. According to federal statistics, 17 people in the United States die each day waiting for an organ transplant. Every 9 minutes, someone is added to the waiting list.

“This isn’t and it shouldn’t be a fight about the COVID vaccine,” Dr. Caplan said. “This isn’t an issue about punishing non-COVID vaccinators. It’s deciding who is going to get a scarce organ.”

“A lot of people [opposed to removing the nonvaccinated from the list] think: ‘Oh, they are just killing those people who won’t take a COVID vaccine.’ That’s not what is going on.”

The transplant candidate must be in the best possible shape overall, Dr. Caplan and doctors agreed. Someone who is smoking, drinking heavily, or abusing drugs isn’t going to the top of the list either. And for other procedures, such as bariatric surgery or knee surgery, some patients are told first to lose weight before a surgeon will operate.

The worry about side effects from the vaccine, which some patients have cited as a concern, is misplaced, Dr. Caplan said. What transplant candidates who refuse the COVID vaccine may not be thinking about is that they are facing a serious operation and will be on numerous anti-rejection drugs, with side effects, after the surgery.

“So to be worried about the side effects of a COVID vaccine is irrational,” he said.
 

Transplants: The process

The patients who were recently removed from the transplant list could seek care and a transplant at an alternate center, said Anne Paschke, a spokesperson for the United Network for Organ Sharing, a nonprofit group that is under contract with the federal government and operates the national Organ Procurement and Transplantation Network (OPTN).

“Transplant hospitals decide which patients to add to the wait list based on their own criteria and medical judgment to create the best chance for a positive transplant outcome,” she said. That’s done with the understanding that patients will help with their medical care.

So, if one program won’t accept a patient, another may. But, if a patient turned down at one center due to refusing to get the COVID vaccine tries another center, the requirements at that hospital may be the same, she said.

OPTN maintains a list of transplant centers. As of Jan. 28, there were 251 transplant centers, according to UNOS, which manages the waiting list, matches donors and recipients, and strives for equity, among other duties.
 

Pretransplant refusers not typical

“The cases we are seeing are outliers,” Dr. Caplan said of the handful of known candidates who have refused the vaccine. Most ask their doctor exactly what they need to do to live and follow those instructions.

Dr. Norman agreed. Most of the kidney patients he cares for who are hoping for a transplant have been on dialysis, “which they do not like. They are doing whatever they can to make sure they don’t go back on dialysis. As a group, they tend to be very adherent, very safety conscious because they understand their risk and they understand the gift they have received [or will receive] through transplantation. They want to do everything they can to respect and protect that gift.”

Not surprisingly, some on the transplant list who are vaccinated have strong opinions about those who refuse to get the vaccine. Dana J. Ufkes, 61, a Seattle realtor, has been on the kidney transplant list – this time – since 2003, hoping for her third transplant. When asked if potential recipients should be removed from the list if they refuse the COVID vaccine, her answer was immediate: “Absolutely.”

At age 17, Ms. Ufkes got a serious kidney infection that went undiagnosed and untreated. Her kidney health worsened, and she needed a transplant. She got her first one in 1986, then again in 1992.

“They last longer than they used to,” she said. But not forever. (According to the American Kidney Fund, transplants from a living kidney donor last about 15-20 years; from a deceased donor, 10-15.)

The decision to decline the vaccine is, of course, each person’s choice, Ms. Ufkes said. But “if they don’t want to be vaccinated [and still want to be on the list], I think that’s BS.”

Citing the lack of organs, “it’s not like they are handing these out like jellybeans.”

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

Among healthy middle-aged men, those who were more anxious were more likely to develop high levels of multiple biomarkers of cardiometabolic risk over a 40-year follow-up in a new study.

“By middle adulthood, higher anxiety levels are associated with stable differences” in biomarkers of risk for coronary artery disease (CAD), stroke, and type 2 diabetes, which “are maintained into older ages,” the researchers wrote.

Anxious individuals “may experience deteriorations in cardiometabolic health earlier in life and remain on a stable trajectory of heightened risk into older ages,” they concluded.

The study, led by Lewina Lee, PhD, was published online Jan. 24, 2022, in the Journal of the American Heart Association.

“Men who had higher levels of anxiety at the beginning of the study had consistently higher biological risk for cardiometabolic disease than less anxious men from midlife into old age,” Dr. Lee, assistant professor of psychiatry, Boston University, summarized in an email.

Clinicians may not screen for heart disease and diabetes, and/or only discuss lifestyle modifications when patients are older or have the first signs of disease, she added.

However, the study findings “suggest that worries and anxiety are associated with preclinical pathophysiological processes that tend to culminate in cardiometabolic disease” and show “the importance of screening for mental health difficulties, such as worries and anxiety, in men as early as in their 30s and 40s,” she stressed.

Since most of the men were White (97%) and veterans (94%), “it would be important for future studies to evaluate if these associations exist among women, people from diverse racial and ethnic groups, and in more socioeconomically varying samples, and to consider how anxiety may relate to the development of cardiometabolic risk in much younger individuals than those in our study,” Dr. Lee said in a press release from the American Heart Association.

“This study adds to the growing body of research that link psychological health to cardiovascular risk,” Glenn N. Levine, MD, who was not involved with this research, told this news organization in an email.

“We know that factors such as depression and stress can increase cardiac risk; this study further supports that anxiety can as well,” added Dr. Levine, chief of cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston.

“Everyone experiences some anxiety in their life,” he added. However, “if a provider senses that a patient’s anxiety is far beyond the ‘normal’ that we all have from time to time, and it is seemingly adversely impacting both their psychological and physical health, it would be reasonable to suggest to the patient that it might be useful to speak with a mental health professional, and if the patient is receptive, to then make a formal consultation or referral,” said Dr. Levine, who was writing group chair of a recent AHA Scientific Statement on mind-heart-body connection.
 

Neuroticism and worry

Several studies have linked anxiety to a greater risk of cardiometabolic disease onset, Dr. Lee and colleagues wrote, but it is unclear if anxious individuals have a steadily worsening risk as they age, or if they have a higher risk in middle age, which stays the same in older age.

To investigate this, they analyzed data from 1561 men who were seen at the VA Boston outpatient clinic and did not have CAD, type 2 diabetes, stroke, or cancer when they enrolled in the Normative Aging Study.

The men had a mean age of 53 years (range, 33-84) in 1975 and were followed until 2015 or until dropout from the study or death.

At baseline, the study participants filled in the Eysenck Personality Inventory, which assesses neuroticism, and also responded to a scale indicating how much they worry about 20 issues (excluding health).

“Neuroticism,” the researchers explained, “is a tendency to perceive experiences as threatening, feel that challenges are uncontrollable, and experience frequent and disproportionately intense negative emotions,” such as fear, anxiety, sadness, and anger, “across many situations.”

“Worry refers to attempts to solve a problem where future outcome is uncertain and potentially positive or negative,” Dr. Lee noted. Although worry can be healthy and lead to constructive solutions, “it may be unhealthy, especially when it becomes uncontrollable and interferes with day-to-day functioning.”

Of note, in 1980, the American Psychiatric Association removed the term neurosis from its diagnostic manual. What was previously called neurosis is included as part of generalized anxiety disorder; GAD also encompasses excessive worry.
 

Cardiometabolic risk from midlife to old age

The men in the current study had on-site physical examinations every 3-5 years.

The researchers calculated the men’s cardiometabolic risk score (from 0 to 7) by assigning 1 point each for the following: systolic blood pressure greater than 130 mm Hg, diastolic blood pressure greater than 85 mm Hg, total cholesterol of at least 240 mg/dL, triglycerides of at least 150 mg/dL, body mass index of at least 30 kg/m2, glucose of at least 100 mg/dL, and erythrocyte sedimentation rate of at least 14 mm/hour.

Alternatively, patients were assigned a point each for taking medication that could affect these markers (except for body mass index).

Overall, on average, at baseline, the men had a cardiometabolic risk score of 2.9. From age 33-65, this score increased to 3.8, and then it did not increase as much later on.

That is, the cardiometabolic risk score increased by 0.8 per decade until age 65, followed by a slower increase of 0.5 per decade.

At all ages, men with higher levels of neuroticism or worry had a higher cardiometabolic risk score

Each additional standard deviation of neuroticism was associated with a 13% increased risk of having six or more of the seven cardiometabolic risk markers during follow-up, after adjusting for age, demographics, and family history of CAD, but the relationship was attenuated after also adjusting for health behaviors (for example, smoking, alcohol consumption, physical activity, and past-year physician visit at baseline).

Similarly, each additional standard deviation of worry was associated with a 10% increased risk of having six or more of the seven cardiometabolic risk markers during follow-up after the same adjustments, and was also no longer significantly different after the same further adjustments.

The research was supported by grants from the National Institutes of Health and a Senior Research Career Scientist Award from the Office of Research and Development, Department of Veterans Affairs. The Normative Aging Study is a research component of the Massachusetts Veterans Epidemiology Research and Information Center and is supported by the VA Cooperative Studies Program/Epidemiological Research Centers. The study authors and Dr. Levine disclosed no relevant financial relationships.

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

Among healthy middle-aged men, those who were more anxious were more likely to develop high levels of multiple biomarkers of cardiometabolic risk over a 40-year follow-up in a new study.

“By middle adulthood, higher anxiety levels are associated with stable differences” in biomarkers of risk for coronary artery disease (CAD), stroke, and type 2 diabetes, which “are maintained into older ages,” the researchers wrote.

Anxious individuals “may experience deteriorations in cardiometabolic health earlier in life and remain on a stable trajectory of heightened risk into older ages,” they concluded.

The study, led by Lewina Lee, PhD, was published online Jan. 24, 2022, in the Journal of the American Heart Association.

“Men who had higher levels of anxiety at the beginning of the study had consistently higher biological risk for cardiometabolic disease than less anxious men from midlife into old age,” Dr. Lee, assistant professor of psychiatry, Boston University, summarized in an email.

Clinicians may not screen for heart disease and diabetes, and/or only discuss lifestyle modifications when patients are older or have the first signs of disease, she added.

However, the study findings “suggest that worries and anxiety are associated with preclinical pathophysiological processes that tend to culminate in cardiometabolic disease” and show “the importance of screening for mental health difficulties, such as worries and anxiety, in men as early as in their 30s and 40s,” she stressed.

Since most of the men were White (97%) and veterans (94%), “it would be important for future studies to evaluate if these associations exist among women, people from diverse racial and ethnic groups, and in more socioeconomically varying samples, and to consider how anxiety may relate to the development of cardiometabolic risk in much younger individuals than those in our study,” Dr. Lee said in a press release from the American Heart Association.

“This study adds to the growing body of research that link psychological health to cardiovascular risk,” Glenn N. Levine, MD, who was not involved with this research, told this news organization in an email.

“We know that factors such as depression and stress can increase cardiac risk; this study further supports that anxiety can as well,” added Dr. Levine, chief of cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston.

“Everyone experiences some anxiety in their life,” he added. However, “if a provider senses that a patient’s anxiety is far beyond the ‘normal’ that we all have from time to time, and it is seemingly adversely impacting both their psychological and physical health, it would be reasonable to suggest to the patient that it might be useful to speak with a mental health professional, and if the patient is receptive, to then make a formal consultation or referral,” said Dr. Levine, who was writing group chair of a recent AHA Scientific Statement on mind-heart-body connection.
 

Neuroticism and worry

Several studies have linked anxiety to a greater risk of cardiometabolic disease onset, Dr. Lee and colleagues wrote, but it is unclear if anxious individuals have a steadily worsening risk as they age, or if they have a higher risk in middle age, which stays the same in older age.

To investigate this, they analyzed data from 1561 men who were seen at the VA Boston outpatient clinic and did not have CAD, type 2 diabetes, stroke, or cancer when they enrolled in the Normative Aging Study.

The men had a mean age of 53 years (range, 33-84) in 1975 and were followed until 2015 or until dropout from the study or death.

At baseline, the study participants filled in the Eysenck Personality Inventory, which assesses neuroticism, and also responded to a scale indicating how much they worry about 20 issues (excluding health).

“Neuroticism,” the researchers explained, “is a tendency to perceive experiences as threatening, feel that challenges are uncontrollable, and experience frequent and disproportionately intense negative emotions,” such as fear, anxiety, sadness, and anger, “across many situations.”

“Worry refers to attempts to solve a problem where future outcome is uncertain and potentially positive or negative,” Dr. Lee noted. Although worry can be healthy and lead to constructive solutions, “it may be unhealthy, especially when it becomes uncontrollable and interferes with day-to-day functioning.”

Of note, in 1980, the American Psychiatric Association removed the term neurosis from its diagnostic manual. What was previously called neurosis is included as part of generalized anxiety disorder; GAD also encompasses excessive worry.
 

Cardiometabolic risk from midlife to old age

The men in the current study had on-site physical examinations every 3-5 years.

The researchers calculated the men’s cardiometabolic risk score (from 0 to 7) by assigning 1 point each for the following: systolic blood pressure greater than 130 mm Hg, diastolic blood pressure greater than 85 mm Hg, total cholesterol of at least 240 mg/dL, triglycerides of at least 150 mg/dL, body mass index of at least 30 kg/m2, glucose of at least 100 mg/dL, and erythrocyte sedimentation rate of at least 14 mm/hour.

Alternatively, patients were assigned a point each for taking medication that could affect these markers (except for body mass index).

Overall, on average, at baseline, the men had a cardiometabolic risk score of 2.9. From age 33-65, this score increased to 3.8, and then it did not increase as much later on.

That is, the cardiometabolic risk score increased by 0.8 per decade until age 65, followed by a slower increase of 0.5 per decade.

At all ages, men with higher levels of neuroticism or worry had a higher cardiometabolic risk score

Each additional standard deviation of neuroticism was associated with a 13% increased risk of having six or more of the seven cardiometabolic risk markers during follow-up, after adjusting for age, demographics, and family history of CAD, but the relationship was attenuated after also adjusting for health behaviors (for example, smoking, alcohol consumption, physical activity, and past-year physician visit at baseline).

Similarly, each additional standard deviation of worry was associated with a 10% increased risk of having six or more of the seven cardiometabolic risk markers during follow-up after the same adjustments, and was also no longer significantly different after the same further adjustments.

The research was supported by grants from the National Institutes of Health and a Senior Research Career Scientist Award from the Office of Research and Development, Department of Veterans Affairs. The Normative Aging Study is a research component of the Massachusetts Veterans Epidemiology Research and Information Center and is supported by the VA Cooperative Studies Program/Epidemiological Research Centers. The study authors and Dr. Levine disclosed no relevant financial relationships.

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

Among healthy middle-aged men, those who were more anxious were more likely to develop high levels of multiple biomarkers of cardiometabolic risk over a 40-year follow-up in a new study.

“By middle adulthood, higher anxiety levels are associated with stable differences” in biomarkers of risk for coronary artery disease (CAD), stroke, and type 2 diabetes, which “are maintained into older ages,” the researchers wrote.

Anxious individuals “may experience deteriorations in cardiometabolic health earlier in life and remain on a stable trajectory of heightened risk into older ages,” they concluded.

The study, led by Lewina Lee, PhD, was published online Jan. 24, 2022, in the Journal of the American Heart Association.

“Men who had higher levels of anxiety at the beginning of the study had consistently higher biological risk for cardiometabolic disease than less anxious men from midlife into old age,” Dr. Lee, assistant professor of psychiatry, Boston University, summarized in an email.

Clinicians may not screen for heart disease and diabetes, and/or only discuss lifestyle modifications when patients are older or have the first signs of disease, she added.

However, the study findings “suggest that worries and anxiety are associated with preclinical pathophysiological processes that tend to culminate in cardiometabolic disease” and show “the importance of screening for mental health difficulties, such as worries and anxiety, in men as early as in their 30s and 40s,” she stressed.

Since most of the men were White (97%) and veterans (94%), “it would be important for future studies to evaluate if these associations exist among women, people from diverse racial and ethnic groups, and in more socioeconomically varying samples, and to consider how anxiety may relate to the development of cardiometabolic risk in much younger individuals than those in our study,” Dr. Lee said in a press release from the American Heart Association.

“This study adds to the growing body of research that link psychological health to cardiovascular risk,” Glenn N. Levine, MD, who was not involved with this research, told this news organization in an email.

“We know that factors such as depression and stress can increase cardiac risk; this study further supports that anxiety can as well,” added Dr. Levine, chief of cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston.

“Everyone experiences some anxiety in their life,” he added. However, “if a provider senses that a patient’s anxiety is far beyond the ‘normal’ that we all have from time to time, and it is seemingly adversely impacting both their psychological and physical health, it would be reasonable to suggest to the patient that it might be useful to speak with a mental health professional, and if the patient is receptive, to then make a formal consultation or referral,” said Dr. Levine, who was writing group chair of a recent AHA Scientific Statement on mind-heart-body connection.
 

Neuroticism and worry

Several studies have linked anxiety to a greater risk of cardiometabolic disease onset, Dr. Lee and colleagues wrote, but it is unclear if anxious individuals have a steadily worsening risk as they age, or if they have a higher risk in middle age, which stays the same in older age.

To investigate this, they analyzed data from 1561 men who were seen at the VA Boston outpatient clinic and did not have CAD, type 2 diabetes, stroke, or cancer when they enrolled in the Normative Aging Study.

The men had a mean age of 53 years (range, 33-84) in 1975 and were followed until 2015 or until dropout from the study or death.

At baseline, the study participants filled in the Eysenck Personality Inventory, which assesses neuroticism, and also responded to a scale indicating how much they worry about 20 issues (excluding health).

“Neuroticism,” the researchers explained, “is a tendency to perceive experiences as threatening, feel that challenges are uncontrollable, and experience frequent and disproportionately intense negative emotions,” such as fear, anxiety, sadness, and anger, “across many situations.”

“Worry refers to attempts to solve a problem where future outcome is uncertain and potentially positive or negative,” Dr. Lee noted. Although worry can be healthy and lead to constructive solutions, “it may be unhealthy, especially when it becomes uncontrollable and interferes with day-to-day functioning.”

Of note, in 1980, the American Psychiatric Association removed the term neurosis from its diagnostic manual. What was previously called neurosis is included as part of generalized anxiety disorder; GAD also encompasses excessive worry.
 

Cardiometabolic risk from midlife to old age

The men in the current study had on-site physical examinations every 3-5 years.

The researchers calculated the men’s cardiometabolic risk score (from 0 to 7) by assigning 1 point each for the following: systolic blood pressure greater than 130 mm Hg, diastolic blood pressure greater than 85 mm Hg, total cholesterol of at least 240 mg/dL, triglycerides of at least 150 mg/dL, body mass index of at least 30 kg/m2, glucose of at least 100 mg/dL, and erythrocyte sedimentation rate of at least 14 mm/hour.

Alternatively, patients were assigned a point each for taking medication that could affect these markers (except for body mass index).

Overall, on average, at baseline, the men had a cardiometabolic risk score of 2.9. From age 33-65, this score increased to 3.8, and then it did not increase as much later on.

That is, the cardiometabolic risk score increased by 0.8 per decade until age 65, followed by a slower increase of 0.5 per decade.

At all ages, men with higher levels of neuroticism or worry had a higher cardiometabolic risk score

Each additional standard deviation of neuroticism was associated with a 13% increased risk of having six or more of the seven cardiometabolic risk markers during follow-up, after adjusting for age, demographics, and family history of CAD, but the relationship was attenuated after also adjusting for health behaviors (for example, smoking, alcohol consumption, physical activity, and past-year physician visit at baseline).

Similarly, each additional standard deviation of worry was associated with a 10% increased risk of having six or more of the seven cardiometabolic risk markers during follow-up after the same adjustments, and was also no longer significantly different after the same further adjustments.

The research was supported by grants from the National Institutes of Health and a Senior Research Career Scientist Award from the Office of Research and Development, Department of Veterans Affairs. The Normative Aging Study is a research component of the Massachusetts Veterans Epidemiology Research and Information Center and is supported by the VA Cooperative Studies Program/Epidemiological Research Centers. The study authors and Dr. Levine disclosed no relevant financial relationships.

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

The American Heart Association (AHA) draws attention to the important bidirectional link between cardiovascular health and brain health in its annual statistical update on heart disease and stroke.

“For several years now, the AHA and the scientific community have increasingly recognized the connections between cardiovascular health and brain health, so it was time for us to cement this into its own chapter, which we highlight as the brain health chapter,” Connie W. Tsao, MD, MPH, chair of the statistical update writing group, with Harvard Medical School, Boston, said in an AHA podcast.

“The global rate of brain disease is quickly outpacing heart disease,” Mitchell S. V. Elkind, MD, immediate past president of the AHA, added in a news release.

“The rate of deaths from Alzheimer’s disease and other dementias rose more than twice as much in the past decade compared to the rate of deaths from heart disease, and that is something we must address,” said Dr. Elkind, with Columbia University Vagelos College of Physicians and Surgeons in New York.

“It’s becoming more evident that reducing vascular disease risk factors can make a real difference in helping people live longer, healthier lives, free of heart disease and brain disease,” Dr. Elkind added.

The AHA’s Heart Disease and Stroke Statistics – 2022 Update was published online January 26 in Circulation).

The report highlights some of the research connecting heart and brain health, including the following:

• A meta-analysis of 139 studies showed that people with midlife hypertension were five times more likely to experience impairment on global cognition and about twice as likely to experience reduced executive function, dementia, and Alzheimer’s disease.
• A meta-analysis of four longitudinal studies found that the risk for dementia associated with heart failure was increased nearly twofold.
• In the large prospective Atherosclerosis Risk in Communities (ARIC) Neurocognitive Study, atrial fibrillation was associated with greater cognitive decline and dementia over 20 years.
• A meta-analysis of 10 prospective studies (including 24,801 participants) showed that coronary heart disease (CHD) was associated with a 40% increased risk of poor cognitive outcomes, including dementia, cognitive impairment, or cognitive decline.

“This new chapter on brain health was a critical one to add,” Dr. Tsao said in the news release.

“The data we’ve collected brings to light the strong correlations between heart health and brain health and makes it an easy story to tell -- what’s good for the heart is good for the brain,” Dr. Tsao added.

Along with the new chapter on brain health, the 2022 statistical update provides the latest statistics and heart disease and stroke. Among the highlights:

• Cardiovascular disease (CVD) remains the leading cause of death worldwide. In the United States in 2019, CVD, listed as the underlying cause of death, accounted for 874,613 deaths, about 2,396 deaths each day. On average, someone dies of CVD every 36 seconds.
• CVD claims more lives each year in the United States than all forms of cancer and chronic lower respiratory disease combined.
• In 2019, CHD was the leading cause (41.3%) of deaths attributable to CVD, followed by other CVD (17.3%), stroke (17.2%), hypertension (11.7%), heart failure (9.9%), and diseases of the arteries (2.8%).
• In 2019, stroke accounted for roughly 1 in every 19 deaths in the United States. On average, someone in the United States has a stroke every 40 seconds and someone dies of stroke every 3 minutes 30 seconds. When considered separately from other CVD, stroke ranks number five among all causes of death in the United States.

While the annual statistics update aims to be a contemporary update of annual heart disease and stroke statistics over the past year, it also examines trends over time, Dr. Tsao explains in the podcast.

“One noteworthy point is that we saw a decline in the rate of cardiovascular mortality over the past three decades or so until about 2010. But over the past decade now, we’re also seeing a rise in these numbers,” she said.

This could be due to rising rates of obesity, diabetes, and poor hypertension control, as well as other lifestyle behaviors, Tsao said.
 

Key risk factor data

Each year, the statistical update gauges the cardiovascular health of Americans by tracking seven key health factors and behaviors that increase risk for heart disease and stroke. Below is a snapshot of the latest risk factor data.

Smoking

In 2019, smoking was the leading risk factor for years of life lost to premature death and the third leading risk factor for years of life lived with disability or injury.

According to the 2020 surgeon general’s report on smoking cessation, more than 480,000 Americans die as a result of cigarette smoking, and more than 41,000 die of secondhand smoke exposure each year (roughly 1 in 5 deaths annually).

One in 7 adults are current smokers, 1 in 6 female adults are current smokers, and 1 in 5 high school students use e-cigarettes.
 

Physical inactivity

In 2018, 25.4% of U.S. adults did not engage in leisure-time physical activity, and only 24.0% met the 2018 Physical Activity Guidelines for Americans for both aerobic and muscle strengthening.

Among U.S. high school students in 2019, only 44.1% were physically active for 60 minutes or more on at least 5 days of the week.
 

Nutrition

While there is some evidence that Americans are improving their diet, fewer than 10% of U.S. adults met guidelines for whole grain, whole fruit, and nonstarchy vegetable consumption each day in 2017–2018.

Overweight/obesity

The prevalence of obesity among adults increased from 1999–2000 through 2017–2018 from 30.5% to 42.4%. Overall prevalence of obesity and severe obesity in U.S. youth 2 to 19 years of age increased from 13.9% to 19.3% and 2.6% to 6.1% between 1999–2000 and 2017–2018.

Cholesterol

Close to 94 million (38.1%) U.S. adults have total cholesterol of 200 mg/dL or higher, according to 2015–2018 data; about 28.0 million (11.5%) have total cholesterol of 240 mg/dL or higher; and 27.8% have high levels of low-density lipoprotein cholesterol (130 mg/dL or higher).

Diabetes

In 2019, 87,647 U.S. deaths were attributed to diabetes; data show that 9.8 million U.S. adults have undiagnosed diabetes, 28.2 million have diagnosed diabetes, and 113.6 million have prediabetes.

Hypertension

A total of 121.5 million (47.3%) U.S. adults have hypertension, based on 2015–2018 data. In 2019, 102,072 U.S. deaths were primarily attributable to hypertension.

This statistical update was prepared by a volunteer writing group on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Disclosures for the writing committee are listed with the original article.



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

The American Heart Association (AHA) draws attention to the important bidirectional link between cardiovascular health and brain health in its annual statistical update on heart disease and stroke.

“For several years now, the AHA and the scientific community have increasingly recognized the connections between cardiovascular health and brain health, so it was time for us to cement this into its own chapter, which we highlight as the brain health chapter,” Connie W. Tsao, MD, MPH, chair of the statistical update writing group, with Harvard Medical School, Boston, said in an AHA podcast.

“The global rate of brain disease is quickly outpacing heart disease,” Mitchell S. V. Elkind, MD, immediate past president of the AHA, added in a news release.

“The rate of deaths from Alzheimer’s disease and other dementias rose more than twice as much in the past decade compared to the rate of deaths from heart disease, and that is something we must address,” said Dr. Elkind, with Columbia University Vagelos College of Physicians and Surgeons in New York.

“It’s becoming more evident that reducing vascular disease risk factors can make a real difference in helping people live longer, healthier lives, free of heart disease and brain disease,” Dr. Elkind added.

The AHA’s Heart Disease and Stroke Statistics – 2022 Update was published online January 26 in Circulation).

The report highlights some of the research connecting heart and brain health, including the following:

• A meta-analysis of 139 studies showed that people with midlife hypertension were five times more likely to experience impairment on global cognition and about twice as likely to experience reduced executive function, dementia, and Alzheimer’s disease.
• A meta-analysis of four longitudinal studies found that the risk for dementia associated with heart failure was increased nearly twofold.
• In the large prospective Atherosclerosis Risk in Communities (ARIC) Neurocognitive Study, atrial fibrillation was associated with greater cognitive decline and dementia over 20 years.
• A meta-analysis of 10 prospective studies (including 24,801 participants) showed that coronary heart disease (CHD) was associated with a 40% increased risk of poor cognitive outcomes, including dementia, cognitive impairment, or cognitive decline.

“This new chapter on brain health was a critical one to add,” Dr. Tsao said in the news release.

“The data we’ve collected brings to light the strong correlations between heart health and brain health and makes it an easy story to tell -- what’s good for the heart is good for the brain,” Dr. Tsao added.

Along with the new chapter on brain health, the 2022 statistical update provides the latest statistics and heart disease and stroke. Among the highlights:

• Cardiovascular disease (CVD) remains the leading cause of death worldwide. In the United States in 2019, CVD, listed as the underlying cause of death, accounted for 874,613 deaths, about 2,396 deaths each day. On average, someone dies of CVD every 36 seconds.
• CVD claims more lives each year in the United States than all forms of cancer and chronic lower respiratory disease combined.
• In 2019, CHD was the leading cause (41.3%) of deaths attributable to CVD, followed by other CVD (17.3%), stroke (17.2%), hypertension (11.7%), heart failure (9.9%), and diseases of the arteries (2.8%).
• In 2019, stroke accounted for roughly 1 in every 19 deaths in the United States. On average, someone in the United States has a stroke every 40 seconds and someone dies of stroke every 3 minutes 30 seconds. When considered separately from other CVD, stroke ranks number five among all causes of death in the United States.

While the annual statistics update aims to be a contemporary update of annual heart disease and stroke statistics over the past year, it also examines trends over time, Dr. Tsao explains in the podcast.

“One noteworthy point is that we saw a decline in the rate of cardiovascular mortality over the past three decades or so until about 2010. But over the past decade now, we’re also seeing a rise in these numbers,” she said.

This could be due to rising rates of obesity, diabetes, and poor hypertension control, as well as other lifestyle behaviors, Tsao said.
 

Key risk factor data

Each year, the statistical update gauges the cardiovascular health of Americans by tracking seven key health factors and behaviors that increase risk for heart disease and stroke. Below is a snapshot of the latest risk factor data.

Smoking

In 2019, smoking was the leading risk factor for years of life lost to premature death and the third leading risk factor for years of life lived with disability or injury.

According to the 2020 surgeon general’s report on smoking cessation, more than 480,000 Americans die as a result of cigarette smoking, and more than 41,000 die of secondhand smoke exposure each year (roughly 1 in 5 deaths annually).

One in 7 adults are current smokers, 1 in 6 female adults are current smokers, and 1 in 5 high school students use e-cigarettes.
 

Physical inactivity

In 2018, 25.4% of U.S. adults did not engage in leisure-time physical activity, and only 24.0% met the 2018 Physical Activity Guidelines for Americans for both aerobic and muscle strengthening.

Among U.S. high school students in 2019, only 44.1% were physically active for 60 minutes or more on at least 5 days of the week.
 

Nutrition

While there is some evidence that Americans are improving their diet, fewer than 10% of U.S. adults met guidelines for whole grain, whole fruit, and nonstarchy vegetable consumption each day in 2017–2018.

Overweight/obesity

The prevalence of obesity among adults increased from 1999–2000 through 2017–2018 from 30.5% to 42.4%. Overall prevalence of obesity and severe obesity in U.S. youth 2 to 19 years of age increased from 13.9% to 19.3% and 2.6% to 6.1% between 1999–2000 and 2017–2018.

Cholesterol

Close to 94 million (38.1%) U.S. adults have total cholesterol of 200 mg/dL or higher, according to 2015–2018 data; about 28.0 million (11.5%) have total cholesterol of 240 mg/dL or higher; and 27.8% have high levels of low-density lipoprotein cholesterol (130 mg/dL or higher).

Diabetes

In 2019, 87,647 U.S. deaths were attributed to diabetes; data show that 9.8 million U.S. adults have undiagnosed diabetes, 28.2 million have diagnosed diabetes, and 113.6 million have prediabetes.

Hypertension

A total of 121.5 million (47.3%) U.S. adults have hypertension, based on 2015–2018 data. In 2019, 102,072 U.S. deaths were primarily attributable to hypertension.

This statistical update was prepared by a volunteer writing group on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Disclosures for the writing committee are listed with the original article.



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

The American Heart Association (AHA) draws attention to the important bidirectional link between cardiovascular health and brain health in its annual statistical update on heart disease and stroke.

“For several years now, the AHA and the scientific community have increasingly recognized the connections between cardiovascular health and brain health, so it was time for us to cement this into its own chapter, which we highlight as the brain health chapter,” Connie W. Tsao, MD, MPH, chair of the statistical update writing group, with Harvard Medical School, Boston, said in an AHA podcast.

“The global rate of brain disease is quickly outpacing heart disease,” Mitchell S. V. Elkind, MD, immediate past president of the AHA, added in a news release.

“The rate of deaths from Alzheimer’s disease and other dementias rose more than twice as much in the past decade compared to the rate of deaths from heart disease, and that is something we must address,” said Dr. Elkind, with Columbia University Vagelos College of Physicians and Surgeons in New York.

“It’s becoming more evident that reducing vascular disease risk factors can make a real difference in helping people live longer, healthier lives, free of heart disease and brain disease,” Dr. Elkind added.

The AHA’s Heart Disease and Stroke Statistics – 2022 Update was published online January 26 in Circulation).

The report highlights some of the research connecting heart and brain health, including the following:

• A meta-analysis of 139 studies showed that people with midlife hypertension were five times more likely to experience impairment on global cognition and about twice as likely to experience reduced executive function, dementia, and Alzheimer’s disease.
• A meta-analysis of four longitudinal studies found that the risk for dementia associated with heart failure was increased nearly twofold.
• In the large prospective Atherosclerosis Risk in Communities (ARIC) Neurocognitive Study, atrial fibrillation was associated with greater cognitive decline and dementia over 20 years.
• A meta-analysis of 10 prospective studies (including 24,801 participants) showed that coronary heart disease (CHD) was associated with a 40% increased risk of poor cognitive outcomes, including dementia, cognitive impairment, or cognitive decline.

“This new chapter on brain health was a critical one to add,” Dr. Tsao said in the news release.

“The data we’ve collected brings to light the strong correlations between heart health and brain health and makes it an easy story to tell -- what’s good for the heart is good for the brain,” Dr. Tsao added.

Along with the new chapter on brain health, the 2022 statistical update provides the latest statistics and heart disease and stroke. Among the highlights:

• Cardiovascular disease (CVD) remains the leading cause of death worldwide. In the United States in 2019, CVD, listed as the underlying cause of death, accounted for 874,613 deaths, about 2,396 deaths each day. On average, someone dies of CVD every 36 seconds.
• CVD claims more lives each year in the United States than all forms of cancer and chronic lower respiratory disease combined.
• In 2019, CHD was the leading cause (41.3%) of deaths attributable to CVD, followed by other CVD (17.3%), stroke (17.2%), hypertension (11.7%), heart failure (9.9%), and diseases of the arteries (2.8%).
• In 2019, stroke accounted for roughly 1 in every 19 deaths in the United States. On average, someone in the United States has a stroke every 40 seconds and someone dies of stroke every 3 minutes 30 seconds. When considered separately from other CVD, stroke ranks number five among all causes of death in the United States.

While the annual statistics update aims to be a contemporary update of annual heart disease and stroke statistics over the past year, it also examines trends over time, Dr. Tsao explains in the podcast.

“One noteworthy point is that we saw a decline in the rate of cardiovascular mortality over the past three decades or so until about 2010. But over the past decade now, we’re also seeing a rise in these numbers,” she said.

This could be due to rising rates of obesity, diabetes, and poor hypertension control, as well as other lifestyle behaviors, Tsao said.
 

Key risk factor data

Each year, the statistical update gauges the cardiovascular health of Americans by tracking seven key health factors and behaviors that increase risk for heart disease and stroke. Below is a snapshot of the latest risk factor data.

Smoking

In 2019, smoking was the leading risk factor for years of life lost to premature death and the third leading risk factor for years of life lived with disability or injury.

According to the 2020 surgeon general’s report on smoking cessation, more than 480,000 Americans die as a result of cigarette smoking, and more than 41,000 die of secondhand smoke exposure each year (roughly 1 in 5 deaths annually).

One in 7 adults are current smokers, 1 in 6 female adults are current smokers, and 1 in 5 high school students use e-cigarettes.
 

Physical inactivity

In 2018, 25.4% of U.S. adults did not engage in leisure-time physical activity, and only 24.0% met the 2018 Physical Activity Guidelines for Americans for both aerobic and muscle strengthening.

Among U.S. high school students in 2019, only 44.1% were physically active for 60 minutes or more on at least 5 days of the week.
 

Nutrition

While there is some evidence that Americans are improving their diet, fewer than 10% of U.S. adults met guidelines for whole grain, whole fruit, and nonstarchy vegetable consumption each day in 2017–2018.

Overweight/obesity

The prevalence of obesity among adults increased from 1999–2000 through 2017–2018 from 30.5% to 42.4%. Overall prevalence of obesity and severe obesity in U.S. youth 2 to 19 years of age increased from 13.9% to 19.3% and 2.6% to 6.1% between 1999–2000 and 2017–2018.

Cholesterol

Close to 94 million (38.1%) U.S. adults have total cholesterol of 200 mg/dL or higher, according to 2015–2018 data; about 28.0 million (11.5%) have total cholesterol of 240 mg/dL or higher; and 27.8% have high levels of low-density lipoprotein cholesterol (130 mg/dL or higher).

Diabetes

In 2019, 87,647 U.S. deaths were attributed to diabetes; data show that 9.8 million U.S. adults have undiagnosed diabetes, 28.2 million have diagnosed diabetes, and 113.6 million have prediabetes.

Hypertension

A total of 121.5 million (47.3%) U.S. adults have hypertension, based on 2015–2018 data. In 2019, 102,072 U.S. deaths were primarily attributable to hypertension.

This statistical update was prepared by a volunteer writing group on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Disclosures for the writing committee are listed with the original article.



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

Americans who have received a COVID-19 booster shot are 97 times less likely to die from the coronavirus than those who aren’t vaccinated, according to a new update from the CDC.

In addition, fully vaccinated Americans — meaning those with up to two doses, but no booster — are 14 times less likely to die from COVID-19 than unvaccinated people.

“These data confirm that vaccination and boosting continues to protect against severe illness and hospitalization, even during the Omicron surge,” Rochelle Walensky, MD, director of the CDC, said during a briefing by the White House COVID-19 Response Team.

“If you are not up to date on your COVID-19 vaccinations, you have not optimized your protection against severe disease and death, and you should get vaccinated and boosted if you are eligible,” she said.

Dr. Walensky presented the latest numbers on Feb. 2 based on reports from 25 jurisdictions in early December. The number of average weekly deaths for those who were unvaccinated was 9.7 per 100,000 people, as compared with 0.7 of those who were vaccinated and 0.1 of those who had received a booster.

“The data are really stunningly obvious why a booster is really very important,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said during the briefing.

Dr. Fauci also encouraged vaccination for those who are pregnant and couples who may want to conceive in the near feature. He highlighted two recent studies that found vaccination in either partner didn’t affect fertility, including in vitro fertilization.

Meanwhile, fertility fell temporarily among men who were infected with the coronavirus. Couples were 18% less likely to conceive if the male partner had contracted the coronavirus within 60 days before a menstrual cycle.

“New data adds to previous studies that indicate that COVID-19 vaccination does not negatively impact fertility,” Dr. Fauci said. “Vaccination is recommended for people who are trying to get pregnant now or might become pregnant in the future, as well as their partners.”

About 80% of eligible Americans have received at least one vaccine dose, and 68% are fully vaccinated, according to the latest CDC data. About 51% of those who are eligible for a booster dose have received one.

The FDA could authorize the Pfizer vaccine for children under age 5 later this month. When that happens, about 18 million children will qualify for a shot, Jeff Zients, coordinator of the White House COVID-19 Response Team, said during the briefing. The Biden administration is already working on distribution plans for the shot for young kids, he added.

“We’ll be ready to start getting shots in arms soon after FDA and CDC make their decisions,” he said.

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

Americans who have received a COVID-19 booster shot are 97 times less likely to die from the coronavirus than those who aren’t vaccinated, according to a new update from the CDC.

In addition, fully vaccinated Americans — meaning those with up to two doses, but no booster — are 14 times less likely to die from COVID-19 than unvaccinated people.

“These data confirm that vaccination and boosting continues to protect against severe illness and hospitalization, even during the Omicron surge,” Rochelle Walensky, MD, director of the CDC, said during a briefing by the White House COVID-19 Response Team.

“If you are not up to date on your COVID-19 vaccinations, you have not optimized your protection against severe disease and death, and you should get vaccinated and boosted if you are eligible,” she said.

Dr. Walensky presented the latest numbers on Feb. 2 based on reports from 25 jurisdictions in early December. The number of average weekly deaths for those who were unvaccinated was 9.7 per 100,000 people, as compared with 0.7 of those who were vaccinated and 0.1 of those who had received a booster.

“The data are really stunningly obvious why a booster is really very important,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said during the briefing.

Dr. Fauci also encouraged vaccination for those who are pregnant and couples who may want to conceive in the near feature. He highlighted two recent studies that found vaccination in either partner didn’t affect fertility, including in vitro fertilization.

Meanwhile, fertility fell temporarily among men who were infected with the coronavirus. Couples were 18% less likely to conceive if the male partner had contracted the coronavirus within 60 days before a menstrual cycle.

“New data adds to previous studies that indicate that COVID-19 vaccination does not negatively impact fertility,” Dr. Fauci said. “Vaccination is recommended for people who are trying to get pregnant now or might become pregnant in the future, as well as their partners.”

About 80% of eligible Americans have received at least one vaccine dose, and 68% are fully vaccinated, according to the latest CDC data. About 51% of those who are eligible for a booster dose have received one.

The FDA could authorize the Pfizer vaccine for children under age 5 later this month. When that happens, about 18 million children will qualify for a shot, Jeff Zients, coordinator of the White House COVID-19 Response Team, said during the briefing. The Biden administration is already working on distribution plans for the shot for young kids, he added.

“We’ll be ready to start getting shots in arms soon after FDA and CDC make their decisions,” he said.

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

Americans who have received a COVID-19 booster shot are 97 times less likely to die from the coronavirus than those who aren’t vaccinated, according to a new update from the CDC.

In addition, fully vaccinated Americans — meaning those with up to two doses, but no booster — are 14 times less likely to die from COVID-19 than unvaccinated people.

“These data confirm that vaccination and boosting continues to protect against severe illness and hospitalization, even during the Omicron surge,” Rochelle Walensky, MD, director of the CDC, said during a briefing by the White House COVID-19 Response Team.

“If you are not up to date on your COVID-19 vaccinations, you have not optimized your protection against severe disease and death, and you should get vaccinated and boosted if you are eligible,” she said.

Dr. Walensky presented the latest numbers on Feb. 2 based on reports from 25 jurisdictions in early December. The number of average weekly deaths for those who were unvaccinated was 9.7 per 100,000 people, as compared with 0.7 of those who were vaccinated and 0.1 of those who had received a booster.

“The data are really stunningly obvious why a booster is really very important,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said during the briefing.

Dr. Fauci also encouraged vaccination for those who are pregnant and couples who may want to conceive in the near feature. He highlighted two recent studies that found vaccination in either partner didn’t affect fertility, including in vitro fertilization.

Meanwhile, fertility fell temporarily among men who were infected with the coronavirus. Couples were 18% less likely to conceive if the male partner had contracted the coronavirus within 60 days before a menstrual cycle.

“New data adds to previous studies that indicate that COVID-19 vaccination does not negatively impact fertility,” Dr. Fauci said. “Vaccination is recommended for people who are trying to get pregnant now or might become pregnant in the future, as well as their partners.”

About 80% of eligible Americans have received at least one vaccine dose, and 68% are fully vaccinated, according to the latest CDC data. About 51% of those who are eligible for a booster dose have received one.

The FDA could authorize the Pfizer vaccine for children under age 5 later this month. When that happens, about 18 million children will qualify for a shot, Jeff Zients, coordinator of the White House COVID-19 Response Team, said during the briefing. The Biden administration is already working on distribution plans for the shot for young kids, he added.

“We’ll be ready to start getting shots in arms soon after FDA and CDC make their decisions,” he said.

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

A subcutaneous antibody combination of casirivimab and imdevimab given to asymptomatic people who tested positive for SARS-CoV-2 significantly lowered the incidence of symptomatic COVID-19 over 28 days, new research shows.

Results of the study by Meagan P. O’Brien, MD, from Regeneron Pharmaceuticals and one of the study’s funders, and coauthors were published online Jan. 14, 2022, in an original investigation in JAMA.

The results suggest new potential for monoclonal antibodies currently used for postexposure prophylaxis and treatment of symptomatic SARS-CoV-2. It has not been clear whether monoclonal antibodies can benefit people with asymptomatic SARS-CoV-2 infection.

The trial included 314 participants (mean age, 41 years; 51.6% women). Of the participants, 310 (99.7%) completed the efficacy assessment period, and 204 were asymptomatic and tested negative at baseline and were included in the primary efficacy analysis.

The subcutaneous combination of casirivimab and imdevimab, 1,200 mg (600 mg each), significantly prevented progression to symptomatic disease (29/100 [29.0%] vs. 44/104 [42.3%] with placebo; odds ratio, 0.54 [95% confidence interval, 0.30-0.97]; P = .04; absolute risk difference, −13.3% [95% CI, −26.3% to −0.3%]).

These results were part of a randomized, double-blind, placebo-controlled, phase 3 trial of close household contacts of a SARS-CoV-2–infected person at 112 sites in the United States, Romania, and Moldova. They were enrolled between July 13, 2020, and Jan. 28, 2021; follow-up ended March 11, 2021.

Asymptomatic people at least 12 years old were eligible if identified within 96 hours of index case positive test collection and were randomly assigned 1:1 to receive one dose of subcutaneous casirivimab and imdevimab (n = 158), or placebo (n = 156).

COVID-19 vaccination was prohibited before enrollment but was allowed after completing the 28-day efficacy assessment period.
 

Caution warranted

In an accompanying editorial, however, Jonathan Z. Li, MD, Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and Rajesh T. Gandhi, MD, Massachusetts General Hospital, Boston, and Harvard Medical School, urged caution in interpreting the results.

They wrote that, although monoclonal antibodies are generally used in individuals at high risk for severe COVID-19, this study population was less vulnerable, with an average age of 41, and 30% had no risk for the disease.

“Of the remainder, the most common risk factor was being overweight (which confers less risk than other factors),” the editorialists wrote.

They pointed out, as did the study authors, that enrollment came before the emergence of the Delta and Omicron variants, and that both casirivimab and imdevimab maintain their activity against Delta but not against Omicron.

“While prevention of symptomatic infection has benefits,” they wrote, “the primary goal of monoclonal antibody therapy is to prevent progression to severe disease; however, this trial was unable to assess this outcome because there were only three hospitalizations (all in the placebo group). Also, this study was conducted prior to widespread COVID-19 vaccination; whether monoclonal antibodies have the same benefit in people who have breakthrough infection after vaccination is not known.”

The editorialists highlighted the subcutaneous delivery in this study.

They wrote that Dr. O’Brien and coauthors provide evidence that subcutaneous administration is effective in infected individuals. “However, high serum monoclonal antibody levels are achieved more quickly after intravenous administration than following subcutaneous injection; it is unknown whether intravenous administration might have led to even greater efficacy for individuals with asymptomatic SARS-CoV-2 infection.”

The authors of the study also add that, despite efforts to recruit non-White participants, relatively few non-White people were enrolled. Additionally, few adolescents were enrolled.

The sample size was also relatively small, they acknowledge, because of a study design in which the infection status of asymptomatic participants was not confirmed at inclusion.

Several of the authors are employees/stockholders of Regeneron, and have a patent pending, which has been licensed and is receiving royalties. The study was supported by Regeneron and F. Hoffmann–La Roche. This trial was conducted jointly with the National Institute of Allergy and Infectious Diseases and the National Institutes of Health. The CoVPN (COVID-19 Prevention Network) is supported by cooperative agreement awards from the NIAID and NIH.

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

A subcutaneous antibody combination of casirivimab and imdevimab given to asymptomatic people who tested positive for SARS-CoV-2 significantly lowered the incidence of symptomatic COVID-19 over 28 days, new research shows.

Results of the study by Meagan P. O’Brien, MD, from Regeneron Pharmaceuticals and one of the study’s funders, and coauthors were published online Jan. 14, 2022, in an original investigation in JAMA.

The results suggest new potential for monoclonal antibodies currently used for postexposure prophylaxis and treatment of symptomatic SARS-CoV-2. It has not been clear whether monoclonal antibodies can benefit people with asymptomatic SARS-CoV-2 infection.

The trial included 314 participants (mean age, 41 years; 51.6% women). Of the participants, 310 (99.7%) completed the efficacy assessment period, and 204 were asymptomatic and tested negative at baseline and were included in the primary efficacy analysis.

The subcutaneous combination of casirivimab and imdevimab, 1,200 mg (600 mg each), significantly prevented progression to symptomatic disease (29/100 [29.0%] vs. 44/104 [42.3%] with placebo; odds ratio, 0.54 [95% confidence interval, 0.30-0.97]; P = .04; absolute risk difference, −13.3% [95% CI, −26.3% to −0.3%]).

These results were part of a randomized, double-blind, placebo-controlled, phase 3 trial of close household contacts of a SARS-CoV-2–infected person at 112 sites in the United States, Romania, and Moldova. They were enrolled between July 13, 2020, and Jan. 28, 2021; follow-up ended March 11, 2021.

Asymptomatic people at least 12 years old were eligible if identified within 96 hours of index case positive test collection and were randomly assigned 1:1 to receive one dose of subcutaneous casirivimab and imdevimab (n = 158), or placebo (n = 156).

COVID-19 vaccination was prohibited before enrollment but was allowed after completing the 28-day efficacy assessment period.
 

Caution warranted

In an accompanying editorial, however, Jonathan Z. Li, MD, Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and Rajesh T. Gandhi, MD, Massachusetts General Hospital, Boston, and Harvard Medical School, urged caution in interpreting the results.

They wrote that, although monoclonal antibodies are generally used in individuals at high risk for severe COVID-19, this study population was less vulnerable, with an average age of 41, and 30% had no risk for the disease.

“Of the remainder, the most common risk factor was being overweight (which confers less risk than other factors),” the editorialists wrote.

They pointed out, as did the study authors, that enrollment came before the emergence of the Delta and Omicron variants, and that both casirivimab and imdevimab maintain their activity against Delta but not against Omicron.

“While prevention of symptomatic infection has benefits,” they wrote, “the primary goal of monoclonal antibody therapy is to prevent progression to severe disease; however, this trial was unable to assess this outcome because there were only three hospitalizations (all in the placebo group). Also, this study was conducted prior to widespread COVID-19 vaccination; whether monoclonal antibodies have the same benefit in people who have breakthrough infection after vaccination is not known.”

The editorialists highlighted the subcutaneous delivery in this study.

They wrote that Dr. O’Brien and coauthors provide evidence that subcutaneous administration is effective in infected individuals. “However, high serum monoclonal antibody levels are achieved more quickly after intravenous administration than following subcutaneous injection; it is unknown whether intravenous administration might have led to even greater efficacy for individuals with asymptomatic SARS-CoV-2 infection.”

The authors of the study also add that, despite efforts to recruit non-White participants, relatively few non-White people were enrolled. Additionally, few adolescents were enrolled.

The sample size was also relatively small, they acknowledge, because of a study design in which the infection status of asymptomatic participants was not confirmed at inclusion.

Several of the authors are employees/stockholders of Regeneron, and have a patent pending, which has been licensed and is receiving royalties. The study was supported by Regeneron and F. Hoffmann–La Roche. This trial was conducted jointly with the National Institute of Allergy and Infectious Diseases and the National Institutes of Health. The CoVPN (COVID-19 Prevention Network) is supported by cooperative agreement awards from the NIAID and NIH.

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

A subcutaneous antibody combination of casirivimab and imdevimab given to asymptomatic people who tested positive for SARS-CoV-2 significantly lowered the incidence of symptomatic COVID-19 over 28 days, new research shows.

Results of the study by Meagan P. O’Brien, MD, from Regeneron Pharmaceuticals and one of the study’s funders, and coauthors were published online Jan. 14, 2022, in an original investigation in JAMA.

The results suggest new potential for monoclonal antibodies currently used for postexposure prophylaxis and treatment of symptomatic SARS-CoV-2. It has not been clear whether monoclonal antibodies can benefit people with asymptomatic SARS-CoV-2 infection.

The trial included 314 participants (mean age, 41 years; 51.6% women). Of the participants, 310 (99.7%) completed the efficacy assessment period, and 204 were asymptomatic and tested negative at baseline and were included in the primary efficacy analysis.

The subcutaneous combination of casirivimab and imdevimab, 1,200 mg (600 mg each), significantly prevented progression to symptomatic disease (29/100 [29.0%] vs. 44/104 [42.3%] with placebo; odds ratio, 0.54 [95% confidence interval, 0.30-0.97]; P = .04; absolute risk difference, −13.3% [95% CI, −26.3% to −0.3%]).

These results were part of a randomized, double-blind, placebo-controlled, phase 3 trial of close household contacts of a SARS-CoV-2–infected person at 112 sites in the United States, Romania, and Moldova. They were enrolled between July 13, 2020, and Jan. 28, 2021; follow-up ended March 11, 2021.

Asymptomatic people at least 12 years old were eligible if identified within 96 hours of index case positive test collection and were randomly assigned 1:1 to receive one dose of subcutaneous casirivimab and imdevimab (n = 158), or placebo (n = 156).

COVID-19 vaccination was prohibited before enrollment but was allowed after completing the 28-day efficacy assessment period.
 

Caution warranted

In an accompanying editorial, however, Jonathan Z. Li, MD, Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and Rajesh T. Gandhi, MD, Massachusetts General Hospital, Boston, and Harvard Medical School, urged caution in interpreting the results.

They wrote that, although monoclonal antibodies are generally used in individuals at high risk for severe COVID-19, this study population was less vulnerable, with an average age of 41, and 30% had no risk for the disease.

“Of the remainder, the most common risk factor was being overweight (which confers less risk than other factors),” the editorialists wrote.

They pointed out, as did the study authors, that enrollment came before the emergence of the Delta and Omicron variants, and that both casirivimab and imdevimab maintain their activity against Delta but not against Omicron.

“While prevention of symptomatic infection has benefits,” they wrote, “the primary goal of monoclonal antibody therapy is to prevent progression to severe disease; however, this trial was unable to assess this outcome because there were only three hospitalizations (all in the placebo group). Also, this study was conducted prior to widespread COVID-19 vaccination; whether monoclonal antibodies have the same benefit in people who have breakthrough infection after vaccination is not known.”

The editorialists highlighted the subcutaneous delivery in this study.

They wrote that Dr. O’Brien and coauthors provide evidence that subcutaneous administration is effective in infected individuals. “However, high serum monoclonal antibody levels are achieved more quickly after intravenous administration than following subcutaneous injection; it is unknown whether intravenous administration might have led to even greater efficacy for individuals with asymptomatic SARS-CoV-2 infection.”

The authors of the study also add that, despite efforts to recruit non-White participants, relatively few non-White people were enrolled. Additionally, few adolescents were enrolled.

The sample size was also relatively small, they acknowledge, because of a study design in which the infection status of asymptomatic participants was not confirmed at inclusion.

Several of the authors are employees/stockholders of Regeneron, and have a patent pending, which has been licensed and is receiving royalties. The study was supported by Regeneron and F. Hoffmann–La Roche. This trial was conducted jointly with the National Institute of Allergy and Infectious Diseases and the National Institutes of Health. The CoVPN (COVID-19 Prevention Network) is supported by cooperative agreement awards from the NIAID and NIH.

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

A new study offers early validation of the recently released Valve Academic Research Consortium 3 (VARC-3) definition of technical success after transcatheter aortic valve replacement (TAVR) and highlights its role in patient prognosis.

Results show that one in 10 patients (11.6%) undergoing TAVR with contemporary devices and techniques experiences technical failure, according to VARC-3.

At 30 days, patients with technical failure had significantly higher rates of the composite of cardiovascular (CV) death or stroke (11.5% vs. 3.5%), CV death (6.0% vs. 1.0%), and stroke (7.2% vs. 2.9%), compared with those with technical success.

Technical failure after TAVR was also independently associated with a twofold higher risk for CV death or stroke at 1 year (20.0% vs. 10.3%; hazard ratio, 2.01; 95% CI, 1.37-2.95).

Other independent predictors were history of peripheral artery disease (HR, 1.97), New York Heart Association III or IV disease (HR, 1.86), baseline moderate or greater mitral regurgitation (HR, 1.48), atrial fibrillation (HR, 1.40), and Society of Thoracic Surgeons predicted mortality risk (HR, 1.04).

“We were expecting that we were getting better over time with device iterations, with more experience, so we weren’t surprised by the result. But I think what is somewhat surprising is how much of an impact it has on the outcome,” senior study author Thomas Pilgrim, MD, Inselspital, University of Bern, Switzerland, told this news organization.

The VARC-3 document, introduced last year to some controversy, features a heavier focus on patient outcomes, as well as composite safety and efficacy endpoints. The definition of technical success after TAVR includes freedom from death; successful access, delivery of the device, and retrieval of the delivery system; correct positioning of a prosthetic heart valve into the proper anatomical location; and freedom from surgery or intervention related to the device or to an access-related or cardiac structural complication.

The composite endpoint is meant to replace the VARC-2 definition of “device success,” which also included freedom from death and correct valve positioning but required echocardiographic evaluation. With VARC-3, there is an “immediate measure” of success without having to wait for echocardiography, observed Dr. Pilgrim.

As reported in the Journal of the American College of Cardiology Cardiovascular Interventions, TAVR was a technical success in 1,435 of 1,624 (88.4%) patients. Technical failure occurred in 189 patients related to either vascular complications (8.6%) or procedural death or cardiac complications (3.0%).

The VARC-2 endpoint of device success was observed in 66.1% of patients. The high rate of device failure was largely attributed to a 28% incidence of prosthesis-patient mismatch.

“If you use the VARC-2 device success [definition], you include this patient–prosthesis mismatch, the [valve] gradients, [and] regurgitation and then device success is always lower,” Dr. Pilgrim said.

Asked whether the VARC-3 definition may be missing case failures, he replied: “At this stage, we don’t know how important these echocardiographic parameters are for hard clinical endpoints. Maybe the VARC-2 endpoint was too sensitive or the VARC-3 endpoint is not sensitive enough. This is something we just don’t know at this stage.”

Marco Barbanti, MD, an interventional cardiologist at Rodolico Polyclinic University Hospital-San Marco, Catania, Italy, and author of an accompanying editorial, said VARC-3 represents a more accurate indicator of immediate success of the procedure.

“It’s a more pertinent definition according to what really has an impact on prognosis, and, according to the results of this paper, actually, the calibration of this new definition is quite good,” Dr. Barbanti said in an interview.

Patients with VARC-3 technical failure were older, had a higher body mass index, and had more advanced heart failure symptoms than those with technical success. There were no significant differences between the two groups in echocardiographic or CT data, anesthetic strategy, valve type or size, or use of pre- or post-dilation.

All patients underwent TAVR with current balloon-expandable (Sapien 3/Sapien Ultra, Edwards Lifesciences) or self-expanding (Evolut R/PRO [Medtronic], Portico [Abbott], Symetis ACURATE/ACURATE neo [Boston Scientific]) devices between March 2012 and December 2019. A transfemoral approach was used in 92.5% of patients.

In a landmark analysis with the landmark set at 30 days, the effect of technical failure on adverse outcome was limited to the first 30 days (composite endpoint 0-30 days: HR, 3.42; P < .001; 30-360 days: HR, 1.36; P = .266; P for interaction = .002).

At 1 year, the composite of CV death and stroke endpoint occurred in 24.1% of patients with cardiac technical failure, in 18.8% of patients with vascular technical failure, and in 10.3% of patients with technical success.

In multivariate analyses, cardiac and vascular technical failures were independently associated with a 2.6-fold and 1.9-fold increased risk, respectively, for the composite of cardiovascular death and stroke at 1 year.

Female sex, larger device landing zone calcium volume, and earlier procedures (March 2012 to July 2016) were associated with a higher risk for cardiac technical failure, whereas, consistent with previous studies, higher body mass index and use of the Prostar/Manta versus the ProGlide closure device predicted vascular technical failure.

The findings “underscore that technical success is highly clinically relevant and may serve as one of the pivotal endpoints to evaluate the improvement of TAVR or for head-to-head comparisons of new devices in future clinical trials,” the authors conclude.

The findings reflect the experience of a single high-volume center with highly experienced operators in the prospective BERN TAVR registry, however, and may not be generalizable to other heart centers, they note. Although the registry has standardized follow-up, independent analysis of echocardiographic and CT, and independent event adjudication, vascular anatomy was not systematically assessed, and the potential exists for confounding from unmeasured variables.

Dr. Pilgrim reports research grants to the institution from Edwards Lifesciences, Boston Scientific, and Biotronik, personal fees from Biotronik and Boston Scientific, and other from HighLife SAS. Dr. Barbanti is a consultant for Edwards Lifesciences and Boston Scientific.

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

A new study offers early validation of the recently released Valve Academic Research Consortium 3 (VARC-3) definition of technical success after transcatheter aortic valve replacement (TAVR) and highlights its role in patient prognosis.

Results show that one in 10 patients (11.6%) undergoing TAVR with contemporary devices and techniques experiences technical failure, according to VARC-3.

At 30 days, patients with technical failure had significantly higher rates of the composite of cardiovascular (CV) death or stroke (11.5% vs. 3.5%), CV death (6.0% vs. 1.0%), and stroke (7.2% vs. 2.9%), compared with those with technical success.

Technical failure after TAVR was also independently associated with a twofold higher risk for CV death or stroke at 1 year (20.0% vs. 10.3%; hazard ratio, 2.01; 95% CI, 1.37-2.95).

Other independent predictors were history of peripheral artery disease (HR, 1.97), New York Heart Association III or IV disease (HR, 1.86), baseline moderate or greater mitral regurgitation (HR, 1.48), atrial fibrillation (HR, 1.40), and Society of Thoracic Surgeons predicted mortality risk (HR, 1.04).

“We were expecting that we were getting better over time with device iterations, with more experience, so we weren’t surprised by the result. But I think what is somewhat surprising is how much of an impact it has on the outcome,” senior study author Thomas Pilgrim, MD, Inselspital, University of Bern, Switzerland, told this news organization.

The VARC-3 document, introduced last year to some controversy, features a heavier focus on patient outcomes, as well as composite safety and efficacy endpoints. The definition of technical success after TAVR includes freedom from death; successful access, delivery of the device, and retrieval of the delivery system; correct positioning of a prosthetic heart valve into the proper anatomical location; and freedom from surgery or intervention related to the device or to an access-related or cardiac structural complication.

The composite endpoint is meant to replace the VARC-2 definition of “device success,” which also included freedom from death and correct valve positioning but required echocardiographic evaluation. With VARC-3, there is an “immediate measure” of success without having to wait for echocardiography, observed Dr. Pilgrim.

As reported in the Journal of the American College of Cardiology Cardiovascular Interventions, TAVR was a technical success in 1,435 of 1,624 (88.4%) patients. Technical failure occurred in 189 patients related to either vascular complications (8.6%) or procedural death or cardiac complications (3.0%).

The VARC-2 endpoint of device success was observed in 66.1% of patients. The high rate of device failure was largely attributed to a 28% incidence of prosthesis-patient mismatch.

“If you use the VARC-2 device success [definition], you include this patient–prosthesis mismatch, the [valve] gradients, [and] regurgitation and then device success is always lower,” Dr. Pilgrim said.

Asked whether the VARC-3 definition may be missing case failures, he replied: “At this stage, we don’t know how important these echocardiographic parameters are for hard clinical endpoints. Maybe the VARC-2 endpoint was too sensitive or the VARC-3 endpoint is not sensitive enough. This is something we just don’t know at this stage.”

Marco Barbanti, MD, an interventional cardiologist at Rodolico Polyclinic University Hospital-San Marco, Catania, Italy, and author of an accompanying editorial, said VARC-3 represents a more accurate indicator of immediate success of the procedure.

“It’s a more pertinent definition according to what really has an impact on prognosis, and, according to the results of this paper, actually, the calibration of this new definition is quite good,” Dr. Barbanti said in an interview.

Patients with VARC-3 technical failure were older, had a higher body mass index, and had more advanced heart failure symptoms than those with technical success. There were no significant differences between the two groups in echocardiographic or CT data, anesthetic strategy, valve type or size, or use of pre- or post-dilation.

All patients underwent TAVR with current balloon-expandable (Sapien 3/Sapien Ultra, Edwards Lifesciences) or self-expanding (Evolut R/PRO [Medtronic], Portico [Abbott], Symetis ACURATE/ACURATE neo [Boston Scientific]) devices between March 2012 and December 2019. A transfemoral approach was used in 92.5% of patients.

In a landmark analysis with the landmark set at 30 days, the effect of technical failure on adverse outcome was limited to the first 30 days (composite endpoint 0-30 days: HR, 3.42; P < .001; 30-360 days: HR, 1.36; P = .266; P for interaction = .002).

At 1 year, the composite of CV death and stroke endpoint occurred in 24.1% of patients with cardiac technical failure, in 18.8% of patients with vascular technical failure, and in 10.3% of patients with technical success.

In multivariate analyses, cardiac and vascular technical failures were independently associated with a 2.6-fold and 1.9-fold increased risk, respectively, for the composite of cardiovascular death and stroke at 1 year.

Female sex, larger device landing zone calcium volume, and earlier procedures (March 2012 to July 2016) were associated with a higher risk for cardiac technical failure, whereas, consistent with previous studies, higher body mass index and use of the Prostar/Manta versus the ProGlide closure device predicted vascular technical failure.

The findings “underscore that technical success is highly clinically relevant and may serve as one of the pivotal endpoints to evaluate the improvement of TAVR or for head-to-head comparisons of new devices in future clinical trials,” the authors conclude.

The findings reflect the experience of a single high-volume center with highly experienced operators in the prospective BERN TAVR registry, however, and may not be generalizable to other heart centers, they note. Although the registry has standardized follow-up, independent analysis of echocardiographic and CT, and independent event adjudication, vascular anatomy was not systematically assessed, and the potential exists for confounding from unmeasured variables.

Dr. Pilgrim reports research grants to the institution from Edwards Lifesciences, Boston Scientific, and Biotronik, personal fees from Biotronik and Boston Scientific, and other from HighLife SAS. Dr. Barbanti is a consultant for Edwards Lifesciences and Boston Scientific.

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

A new study offers early validation of the recently released Valve Academic Research Consortium 3 (VARC-3) definition of technical success after transcatheter aortic valve replacement (TAVR) and highlights its role in patient prognosis.

Results show that one in 10 patients (11.6%) undergoing TAVR with contemporary devices and techniques experiences technical failure, according to VARC-3.

At 30 days, patients with technical failure had significantly higher rates of the composite of cardiovascular (CV) death or stroke (11.5% vs. 3.5%), CV death (6.0% vs. 1.0%), and stroke (7.2% vs. 2.9%), compared with those with technical success.

Technical failure after TAVR was also independently associated with a twofold higher risk for CV death or stroke at 1 year (20.0% vs. 10.3%; hazard ratio, 2.01; 95% CI, 1.37-2.95).

Other independent predictors were history of peripheral artery disease (HR, 1.97), New York Heart Association III or IV disease (HR, 1.86), baseline moderate or greater mitral regurgitation (HR, 1.48), atrial fibrillation (HR, 1.40), and Society of Thoracic Surgeons predicted mortality risk (HR, 1.04).

“We were expecting that we were getting better over time with device iterations, with more experience, so we weren’t surprised by the result. But I think what is somewhat surprising is how much of an impact it has on the outcome,” senior study author Thomas Pilgrim, MD, Inselspital, University of Bern, Switzerland, told this news organization.

The VARC-3 document, introduced last year to some controversy, features a heavier focus on patient outcomes, as well as composite safety and efficacy endpoints. The definition of technical success after TAVR includes freedom from death; successful access, delivery of the device, and retrieval of the delivery system; correct positioning of a prosthetic heart valve into the proper anatomical location; and freedom from surgery or intervention related to the device or to an access-related or cardiac structural complication.

The composite endpoint is meant to replace the VARC-2 definition of “device success,” which also included freedom from death and correct valve positioning but required echocardiographic evaluation. With VARC-3, there is an “immediate measure” of success without having to wait for echocardiography, observed Dr. Pilgrim.

As reported in the Journal of the American College of Cardiology Cardiovascular Interventions, TAVR was a technical success in 1,435 of 1,624 (88.4%) patients. Technical failure occurred in 189 patients related to either vascular complications (8.6%) or procedural death or cardiac complications (3.0%).

The VARC-2 endpoint of device success was observed in 66.1% of patients. The high rate of device failure was largely attributed to a 28% incidence of prosthesis-patient mismatch.

“If you use the VARC-2 device success [definition], you include this patient–prosthesis mismatch, the [valve] gradients, [and] regurgitation and then device success is always lower,” Dr. Pilgrim said.

Asked whether the VARC-3 definition may be missing case failures, he replied: “At this stage, we don’t know how important these echocardiographic parameters are for hard clinical endpoints. Maybe the VARC-2 endpoint was too sensitive or the VARC-3 endpoint is not sensitive enough. This is something we just don’t know at this stage.”

Marco Barbanti, MD, an interventional cardiologist at Rodolico Polyclinic University Hospital-San Marco, Catania, Italy, and author of an accompanying editorial, said VARC-3 represents a more accurate indicator of immediate success of the procedure.

“It’s a more pertinent definition according to what really has an impact on prognosis, and, according to the results of this paper, actually, the calibration of this new definition is quite good,” Dr. Barbanti said in an interview.

Patients with VARC-3 technical failure were older, had a higher body mass index, and had more advanced heart failure symptoms than those with technical success. There were no significant differences between the two groups in echocardiographic or CT data, anesthetic strategy, valve type or size, or use of pre- or post-dilation.

All patients underwent TAVR with current balloon-expandable (Sapien 3/Sapien Ultra, Edwards Lifesciences) or self-expanding (Evolut R/PRO [Medtronic], Portico [Abbott], Symetis ACURATE/ACURATE neo [Boston Scientific]) devices between March 2012 and December 2019. A transfemoral approach was used in 92.5% of patients.

In a landmark analysis with the landmark set at 30 days, the effect of technical failure on adverse outcome was limited to the first 30 days (composite endpoint 0-30 days: HR, 3.42; P < .001; 30-360 days: HR, 1.36; P = .266; P for interaction = .002).

At 1 year, the composite of CV death and stroke endpoint occurred in 24.1% of patients with cardiac technical failure, in 18.8% of patients with vascular technical failure, and in 10.3% of patients with technical success.

In multivariate analyses, cardiac and vascular technical failures were independently associated with a 2.6-fold and 1.9-fold increased risk, respectively, for the composite of cardiovascular death and stroke at 1 year.

Female sex, larger device landing zone calcium volume, and earlier procedures (March 2012 to July 2016) were associated with a higher risk for cardiac technical failure, whereas, consistent with previous studies, higher body mass index and use of the Prostar/Manta versus the ProGlide closure device predicted vascular technical failure.

The findings “underscore that technical success is highly clinically relevant and may serve as one of the pivotal endpoints to evaluate the improvement of TAVR or for head-to-head comparisons of new devices in future clinical trials,” the authors conclude.

The findings reflect the experience of a single high-volume center with highly experienced operators in the prospective BERN TAVR registry, however, and may not be generalizable to other heart centers, they note. Although the registry has standardized follow-up, independent analysis of echocardiographic and CT, and independent event adjudication, vascular anatomy was not systematically assessed, and the potential exists for confounding from unmeasured variables.

Dr. Pilgrim reports research grants to the institution from Edwards Lifesciences, Boston Scientific, and Biotronik, personal fees from Biotronik and Boston Scientific, and other from HighLife SAS. Dr. Barbanti is a consultant for Edwards Lifesciences and Boston Scientific.

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

The investigational, next-generation cardiac myosin inhibitor aficamten (previously CK-274, Cytokinetics) continues to show promise as a potential treatment for hypertrophic cardiomyopathy (HCM).

Today, the company announced positive topline results from cohort 3 of the REDWOOD-HCM phase 2 clinical trial, which included 13 patients with symptomatic obstructive HCM and a resting or post-Valsalva left ventricular outflow tract pressure gradient (LVOT-G) of 50 mm Hg or greater whose background therapy included disopyramide.

Treatment with aficamten led to substantial reductions in the average resting LVOT-G, as well as the post-Valsalva LVOT-G (defined as resting gradient less than 30 mm Hg and post-Valsalva gradient less than 50 mm Hg), the company reported.

These “clinically relevant” decreases in pressure gradients were achieved with only modest decreases in average left ventricular ejection fraction (LVEF), the company said. 

In no patient did LVEF fall below the prespecified safety threshold of 50%.

New York Heart Association (NYHA) functional class was improved in most patients.

The safety and tolerability of aficamten in cohort 3 were consistent with previous experience in the REDWOOD-HCM trial, with no treatment interruptions and no serious treatment-related adverse events.

The pharmacokinetic data from cohort 3 are similar to those observed in REDWOOD-HCM cohorts 1 and 2, which included HCM patients taking background medications exclusive of disopyramide, as reported previously by this news organization.

“We are encouraged by the clinically relevant reductions in the LVOT gradient observed in these medically refractory patients and are pleased with the safety profile of aficamten when administered in combination with disopyramide,” Fady Malik, MD, PhD, Cytokinetics’ executive vice president of research and development, said in a news release.

“These results represent the first report of patients with obstructive HCM treated with a combination of a cardiac myosin inhibitor and disopyramide and support our plan to include this patient population in SEQUOIA-HCM, our phase 3 trial, which is important, given these patients have exhausted other available medical therapies,” Dr. Malik said.

The results from cohort 3 of the REDWOOD-HCM trial will be presented at the upcoming American College of Cardiology Annual Meeting in April.

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

The investigational, next-generation cardiac myosin inhibitor aficamten (previously CK-274, Cytokinetics) continues to show promise as a potential treatment for hypertrophic cardiomyopathy (HCM).

Today, the company announced positive topline results from cohort 3 of the REDWOOD-HCM phase 2 clinical trial, which included 13 patients with symptomatic obstructive HCM and a resting or post-Valsalva left ventricular outflow tract pressure gradient (LVOT-G) of 50 mm Hg or greater whose background therapy included disopyramide.

Treatment with aficamten led to substantial reductions in the average resting LVOT-G, as well as the post-Valsalva LVOT-G (defined as resting gradient less than 30 mm Hg and post-Valsalva gradient less than 50 mm Hg), the company reported.

These “clinically relevant” decreases in pressure gradients were achieved with only modest decreases in average left ventricular ejection fraction (LVEF), the company said. 

In no patient did LVEF fall below the prespecified safety threshold of 50%.

New York Heart Association (NYHA) functional class was improved in most patients.

The safety and tolerability of aficamten in cohort 3 were consistent with previous experience in the REDWOOD-HCM trial, with no treatment interruptions and no serious treatment-related adverse events.

The pharmacokinetic data from cohort 3 are similar to those observed in REDWOOD-HCM cohorts 1 and 2, which included HCM patients taking background medications exclusive of disopyramide, as reported previously by this news organization.

“We are encouraged by the clinically relevant reductions in the LVOT gradient observed in these medically refractory patients and are pleased with the safety profile of aficamten when administered in combination with disopyramide,” Fady Malik, MD, PhD, Cytokinetics’ executive vice president of research and development, said in a news release.

“These results represent the first report of patients with obstructive HCM treated with a combination of a cardiac myosin inhibitor and disopyramide and support our plan to include this patient population in SEQUOIA-HCM, our phase 3 trial, which is important, given these patients have exhausted other available medical therapies,” Dr. Malik said.

The results from cohort 3 of the REDWOOD-HCM trial will be presented at the upcoming American College of Cardiology Annual Meeting in April.

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

The investigational, next-generation cardiac myosin inhibitor aficamten (previously CK-274, Cytokinetics) continues to show promise as a potential treatment for hypertrophic cardiomyopathy (HCM).

Today, the company announced positive topline results from cohort 3 of the REDWOOD-HCM phase 2 clinical trial, which included 13 patients with symptomatic obstructive HCM and a resting or post-Valsalva left ventricular outflow tract pressure gradient (LVOT-G) of 50 mm Hg or greater whose background therapy included disopyramide.

Treatment with aficamten led to substantial reductions in the average resting LVOT-G, as well as the post-Valsalva LVOT-G (defined as resting gradient less than 30 mm Hg and post-Valsalva gradient less than 50 mm Hg), the company reported.

These “clinically relevant” decreases in pressure gradients were achieved with only modest decreases in average left ventricular ejection fraction (LVEF), the company said. 

In no patient did LVEF fall below the prespecified safety threshold of 50%.

New York Heart Association (NYHA) functional class was improved in most patients.

The safety and tolerability of aficamten in cohort 3 were consistent with previous experience in the REDWOOD-HCM trial, with no treatment interruptions and no serious treatment-related adverse events.

The pharmacokinetic data from cohort 3 are similar to those observed in REDWOOD-HCM cohorts 1 and 2, which included HCM patients taking background medications exclusive of disopyramide, as reported previously by this news organization.

“We are encouraged by the clinically relevant reductions in the LVOT gradient observed in these medically refractory patients and are pleased with the safety profile of aficamten when administered in combination with disopyramide,” Fady Malik, MD, PhD, Cytokinetics’ executive vice president of research and development, said in a news release.

“These results represent the first report of patients with obstructive HCM treated with a combination of a cardiac myosin inhibitor and disopyramide and support our plan to include this patient population in SEQUOIA-HCM, our phase 3 trial, which is important, given these patients have exhausted other available medical therapies,” Dr. Malik said.

The results from cohort 3 of the REDWOOD-HCM trial will be presented at the upcoming American College of Cardiology Annual Meeting in April.

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

The world’s most valuable mouse

You’ve heard of Mighty Mouse. Now say hello to the world’s newest mouse superhero, Crypto-Mouse! After being bitten by a radioactive cryptocurrency investor, Crypto-Mouse can tap directly into the power of the blockchain itself, allowing it to perform incredible, death-defying feats of strength!

We’re going to stop right there before Crypto-Mouse gains entry into the Marvel cinematic universe. Let’s rewind to the beginning, because that’s precisely where this crazy scheme is at. In late January, a new decentralized autonomous organization, BitMouseDAO, launched to enormous … -ly little fanfare, according to Vice. Two investors as of Jan. 31. But what they lack in money they make up for in sheer ambition.

Clker-Free-Vector-Images/Pixabay

BitMouseDAO’s $100 million dollar idea is to genetically engineer mice to carry bitcoin, the first cryptocurrency and one of the most valuable. This isn’t as crazy an idea as it sounds since DNA can be modified to store information, potentially even bitcoin information. Their plan is to create a private bitcoin wallet, which will be stored in the mouse DNA, and purchase online bitcoin to store in this wallet.

BitMouseDAO, being a “collection of artists,” plans to partner with a lab to translate its private key into a specific DNA sequence to be encoded into the mice during fertilization; or, if that doesn’t work, inject them with a harmless virus that carries the key.

Since these are artists, their ultimate plan is to use their bitcoin mice to make NFTs (scratch that off your cryptocurrency bingo card) and auction them off to people. Or, as Vice put it, BitMouseDAO essentially plans to send preserved dead mice to people. Artistic dead mice! Artistic dead mice worth millions! Maybe. Even BitMouseDAO admits bitcoin could be worthless by the time the project gets off the ground.

If this all sounds completely insane, that’s because it is. But it also sounds crazy enough to work. Now, if you’ll excuse us, we’re off to write a screenplay about a scrappy group of high-tech thieves who steal a group of genetically altered bitcoin mice to sell for millions, only to keep them as their adorable pets. Trust us Hollywood, it’ll make millions!
 

Alcoholic monkeys vs. the future of feces

Which is more important, the journey or the destination? Science is all about the destination, yes? Solving the problem, saving a life, expanding horizons. That’s science. Or is it? The scientific method is a process, so does that make it a journey?

Amandad/Pixabay

For us, today’s journey begins at the University of Iowa, where investigators are trying to reduce alcohol consumption. A worthy goal, and they seem to have made some progress by targeting a liver hormone called fibroblast growth factor 21 (FGF21). But we’re more interested in the process right now, so bring on the alcoholic monkeys. And no, that’s not a death metal/reggae fusion band. Should be, though.

“The vervet monkey population is [composed] of alcohol avoiders, moderate alcohol drinkers, and a group of heavy drinkers,” Matthew Potthoff, PhD, and associates wrote in Cell Metabolism. When this particular bunch of heavy-drinking vervets were given FGF21, they consumed 50% less alcohol than did vehicle-treated controls, so mission accomplished.

Maybe it could be a breakfast cereal. Who wouldn’t enjoy a bowl of alcoholic monkeys in the morning?

And after breakfast, you might be ready for a digitized bowel movement, courtesy of researchers at University of California, San Diego. They’re studying ulcerative colitis (UC) by examining the gut microbiome, and their “most useful biological sample is patient stool,” according to a written statement from the university.

“Once we had all the technology to digitize the stool, the question was, is this going to tell us what’s happening in these patients? The answer turned out to be yes,” co-senior author Rob Knight, PhD, said in the statement. “Digitizing fecal material is the future.” The road to UC treatment, in other words, is paved with digital stool.

About 40% of the UC patients had elevated protease levels, and their high-protease feces were then transplanted into germ-free mice, which subsequently developed colitis and were successfully treated with protease inhibitors. And that is our final destination.

As our revered founder and mentor, Josephine Lotmevich, used to say, an alcoholic monkey in the hand is worth a number 2 in the bush.
 

Raise a glass to delinquency

You wouldn’t think that a glass of water could lead to a life of crime, but a recent study suggests just that.

PxHere

Children exposed to lead in their drinking water during their early years had a 21% higher risk of delinquency after the age of 14 years and a 38% higher risk of having a record for a serious complaint, Jackie MacDonald Gibson and associates said in a statement on Eurekalert.

Data for the study came from Wake County, N.C., which includes rural areas, wealthy exurban developments, and predominantly Black communities. The investigators compared the blood lead levels for children tested between 1998 and 2011 with juvenile delinquency reports of the same children from the N.C. Department of Public Safety.

The main culprit, they found, was well water. Blood lead levels were 11% higher in the children whose water came from private wells, compared with children using community water. About 13% of U.S. households rely on private wells, which are not regulated under the Safe Drinking Water Act, for their water supply.

The researchers said there is an urgent need for better drinking-water solutions in communities that rely on well water, whether it be through subsidized home filtration or infrastructure redevelopment.

An earlier study had estimated that preventing just one child from entering the adult criminal justice system would save $1.3 to $1.5 million in 1997 dollars. That’s about $2.2 to $2.5 million dollars today!

If you do the math, it’s not hard to see what’s cheaper (and healthier) in the long run.
 

A ‘dirty’ scam

Another one? This is just getting sad. You’ve probably heard of muds and clays being good for the skin and maybe you’ve gone to a spa and sat in a mud bath, but would you believe it if someone told you that mud can cure all your ailments? No? Neither would we. Senatorial candidate Beto O’Rourke was definitely someone who brought this strange treatment to light, but it seems like this is something that has been going on for years, even before the pandemic.

Nandan/Pixahive

A company called Black Oxygen Organics (BOO) was selling “magic dirt” for $110 per 4-ounce package. It claimed the dirt was high in fulvic acid and humic acid, which are good for many things. They were, however, literally getting this mud from bogs with landfills nearby, Mel magazine reported.

That doesn’t sound appealing at all, but wait, there’s more. People were eating, drinking, bathing, and feeding their families this sludge in hopes that they would be cured of their ailments. A lot of people jumped aboard the magic dirt train when the pandemic arose, but it quickly became clear that this mud was not as helpful as BOO claimed it to be.

“We began to receive inquiries and calls on our website with people having problems and issues. Ultimately, we sent the products out for independent testing, and then when that came back and showed that there were toxic heavy metals [lead, arsenic, and cadmium among them] at an unsafe level, that’s when we knew we had to act,” Atlanta-based attorney Matt Wetherington, who filed a federal lawsuit against BOO, told Mel.

After a very complicated series of events involving an expose by NBC, product recalls, extortion claims, and grassroots activism, BOO was shut down by both the Canadian and U.S. governments.

As always, please listen only to health care professionals when you wish to use natural remedies for illnesses and ailments.

The world’s most valuable mouse

You’ve heard of Mighty Mouse. Now say hello to the world’s newest mouse superhero, Crypto-Mouse! After being bitten by a radioactive cryptocurrency investor, Crypto-Mouse can tap directly into the power of the blockchain itself, allowing it to perform incredible, death-defying feats of strength!

We’re going to stop right there before Crypto-Mouse gains entry into the Marvel cinematic universe. Let’s rewind to the beginning, because that’s precisely where this crazy scheme is at. In late January, a new decentralized autonomous organization, BitMouseDAO, launched to enormous … -ly little fanfare, according to Vice. Two investors as of Jan. 31. But what they lack in money they make up for in sheer ambition.

Clker-Free-Vector-Images/Pixabay

BitMouseDAO’s $100 million dollar idea is to genetically engineer mice to carry bitcoin, the first cryptocurrency and one of the most valuable. This isn’t as crazy an idea as it sounds since DNA can be modified to store information, potentially even bitcoin information. Their plan is to create a private bitcoin wallet, which will be stored in the mouse DNA, and purchase online bitcoin to store in this wallet.

BitMouseDAO, being a “collection of artists,” plans to partner with a lab to translate its private key into a specific DNA sequence to be encoded into the mice during fertilization; or, if that doesn’t work, inject them with a harmless virus that carries the key.

Since these are artists, their ultimate plan is to use their bitcoin mice to make NFTs (scratch that off your cryptocurrency bingo card) and auction them off to people. Or, as Vice put it, BitMouseDAO essentially plans to send preserved dead mice to people. Artistic dead mice! Artistic dead mice worth millions! Maybe. Even BitMouseDAO admits bitcoin could be worthless by the time the project gets off the ground.

If this all sounds completely insane, that’s because it is. But it also sounds crazy enough to work. Now, if you’ll excuse us, we’re off to write a screenplay about a scrappy group of high-tech thieves who steal a group of genetically altered bitcoin mice to sell for millions, only to keep them as their adorable pets. Trust us Hollywood, it’ll make millions!
 

Alcoholic monkeys vs. the future of feces

Which is more important, the journey or the destination? Science is all about the destination, yes? Solving the problem, saving a life, expanding horizons. That’s science. Or is it? The scientific method is a process, so does that make it a journey?

Amandad/Pixabay

For us, today’s journey begins at the University of Iowa, where investigators are trying to reduce alcohol consumption. A worthy goal, and they seem to have made some progress by targeting a liver hormone called fibroblast growth factor 21 (FGF21). But we’re more interested in the process right now, so bring on the alcoholic monkeys. And no, that’s not a death metal/reggae fusion band. Should be, though.

“The vervet monkey population is [composed] of alcohol avoiders, moderate alcohol drinkers, and a group of heavy drinkers,” Matthew Potthoff, PhD, and associates wrote in Cell Metabolism. When this particular bunch of heavy-drinking vervets were given FGF21, they consumed 50% less alcohol than did vehicle-treated controls, so mission accomplished.

Maybe it could be a breakfast cereal. Who wouldn’t enjoy a bowl of alcoholic monkeys in the morning?

And after breakfast, you might be ready for a digitized bowel movement, courtesy of researchers at University of California, San Diego. They’re studying ulcerative colitis (UC) by examining the gut microbiome, and their “most useful biological sample is patient stool,” according to a written statement from the university.

“Once we had all the technology to digitize the stool, the question was, is this going to tell us what’s happening in these patients? The answer turned out to be yes,” co-senior author Rob Knight, PhD, said in the statement. “Digitizing fecal material is the future.” The road to UC treatment, in other words, is paved with digital stool.

About 40% of the UC patients had elevated protease levels, and their high-protease feces were then transplanted into germ-free mice, which subsequently developed colitis and were successfully treated with protease inhibitors. And that is our final destination.

As our revered founder and mentor, Josephine Lotmevich, used to say, an alcoholic monkey in the hand is worth a number 2 in the bush.
 

Raise a glass to delinquency

You wouldn’t think that a glass of water could lead to a life of crime, but a recent study suggests just that.

PxHere

Children exposed to lead in their drinking water during their early years had a 21% higher risk of delinquency after the age of 14 years and a 38% higher risk of having a record for a serious complaint, Jackie MacDonald Gibson and associates said in a statement on Eurekalert.

Data for the study came from Wake County, N.C., which includes rural areas, wealthy exurban developments, and predominantly Black communities. The investigators compared the blood lead levels for children tested between 1998 and 2011 with juvenile delinquency reports of the same children from the N.C. Department of Public Safety.

The main culprit, they found, was well water. Blood lead levels were 11% higher in the children whose water came from private wells, compared with children using community water. About 13% of U.S. households rely on private wells, which are not regulated under the Safe Drinking Water Act, for their water supply.

The researchers said there is an urgent need for better drinking-water solutions in communities that rely on well water, whether it be through subsidized home filtration or infrastructure redevelopment.

An earlier study had estimated that preventing just one child from entering the adult criminal justice system would save $1.3 to $1.5 million in 1997 dollars. That’s about $2.2 to $2.5 million dollars today!

If you do the math, it’s not hard to see what’s cheaper (and healthier) in the long run.
 

A ‘dirty’ scam

Another one? This is just getting sad. You’ve probably heard of muds and clays being good for the skin and maybe you’ve gone to a spa and sat in a mud bath, but would you believe it if someone told you that mud can cure all your ailments? No? Neither would we. Senatorial candidate Beto O’Rourke was definitely someone who brought this strange treatment to light, but it seems like this is something that has been going on for years, even before the pandemic.

Nandan/Pixahive

A company called Black Oxygen Organics (BOO) was selling “magic dirt” for $110 per 4-ounce package. It claimed the dirt was high in fulvic acid and humic acid, which are good for many things. They were, however, literally getting this mud from bogs with landfills nearby, Mel magazine reported.

That doesn’t sound appealing at all, but wait, there’s more. People were eating, drinking, bathing, and feeding their families this sludge in hopes that they would be cured of their ailments. A lot of people jumped aboard the magic dirt train when the pandemic arose, but it quickly became clear that this mud was not as helpful as BOO claimed it to be.

“We began to receive inquiries and calls on our website with people having problems and issues. Ultimately, we sent the products out for independent testing, and then when that came back and showed that there were toxic heavy metals [lead, arsenic, and cadmium among them] at an unsafe level, that’s when we knew we had to act,” Atlanta-based attorney Matt Wetherington, who filed a federal lawsuit against BOO, told Mel.

After a very complicated series of events involving an expose by NBC, product recalls, extortion claims, and grassroots activism, BOO was shut down by both the Canadian and U.S. governments.

As always, please listen only to health care professionals when you wish to use natural remedies for illnesses and ailments.

The world’s most valuable mouse

You’ve heard of Mighty Mouse. Now say hello to the world’s newest mouse superhero, Crypto-Mouse! After being bitten by a radioactive cryptocurrency investor, Crypto-Mouse can tap directly into the power of the blockchain itself, allowing it to perform incredible, death-defying feats of strength!

We’re going to stop right there before Crypto-Mouse gains entry into the Marvel cinematic universe. Let’s rewind to the beginning, because that’s precisely where this crazy scheme is at. In late January, a new decentralized autonomous organization, BitMouseDAO, launched to enormous … -ly little fanfare, according to Vice. Two investors as of Jan. 31. But what they lack in money they make up for in sheer ambition.

Clker-Free-Vector-Images/Pixabay

BitMouseDAO’s $100 million dollar idea is to genetically engineer mice to carry bitcoin, the first cryptocurrency and one of the most valuable. This isn’t as crazy an idea as it sounds since DNA can be modified to store information, potentially even bitcoin information. Their plan is to create a private bitcoin wallet, which will be stored in the mouse DNA, and purchase online bitcoin to store in this wallet.

BitMouseDAO, being a “collection of artists,” plans to partner with a lab to translate its private key into a specific DNA sequence to be encoded into the mice during fertilization; or, if that doesn’t work, inject them with a harmless virus that carries the key.

Since these are artists, their ultimate plan is to use their bitcoin mice to make NFTs (scratch that off your cryptocurrency bingo card) and auction them off to people. Or, as Vice put it, BitMouseDAO essentially plans to send preserved dead mice to people. Artistic dead mice! Artistic dead mice worth millions! Maybe. Even BitMouseDAO admits bitcoin could be worthless by the time the project gets off the ground.

If this all sounds completely insane, that’s because it is. But it also sounds crazy enough to work. Now, if you’ll excuse us, we’re off to write a screenplay about a scrappy group of high-tech thieves who steal a group of genetically altered bitcoin mice to sell for millions, only to keep them as their adorable pets. Trust us Hollywood, it’ll make millions!
 

Alcoholic monkeys vs. the future of feces

Which is more important, the journey or the destination? Science is all about the destination, yes? Solving the problem, saving a life, expanding horizons. That’s science. Or is it? The scientific method is a process, so does that make it a journey?

Amandad/Pixabay

For us, today’s journey begins at the University of Iowa, where investigators are trying to reduce alcohol consumption. A worthy goal, and they seem to have made some progress by targeting a liver hormone called fibroblast growth factor 21 (FGF21). But we’re more interested in the process right now, so bring on the alcoholic monkeys. And no, that’s not a death metal/reggae fusion band. Should be, though.

“The vervet monkey population is [composed] of alcohol avoiders, moderate alcohol drinkers, and a group of heavy drinkers,” Matthew Potthoff, PhD, and associates wrote in Cell Metabolism. When this particular bunch of heavy-drinking vervets were given FGF21, they consumed 50% less alcohol than did vehicle-treated controls, so mission accomplished.

Maybe it could be a breakfast cereal. Who wouldn’t enjoy a bowl of alcoholic monkeys in the morning?

And after breakfast, you might be ready for a digitized bowel movement, courtesy of researchers at University of California, San Diego. They’re studying ulcerative colitis (UC) by examining the gut microbiome, and their “most useful biological sample is patient stool,” according to a written statement from the university.

“Once we had all the technology to digitize the stool, the question was, is this going to tell us what’s happening in these patients? The answer turned out to be yes,” co-senior author Rob Knight, PhD, said in the statement. “Digitizing fecal material is the future.” The road to UC treatment, in other words, is paved with digital stool.

About 40% of the UC patients had elevated protease levels, and their high-protease feces were then transplanted into germ-free mice, which subsequently developed colitis and were successfully treated with protease inhibitors. And that is our final destination.

As our revered founder and mentor, Josephine Lotmevich, used to say, an alcoholic monkey in the hand is worth a number 2 in the bush.
 

Raise a glass to delinquency

You wouldn’t think that a glass of water could lead to a life of crime, but a recent study suggests just that.

PxHere

Children exposed to lead in their drinking water during their early years had a 21% higher risk of delinquency after the age of 14 years and a 38% higher risk of having a record for a serious complaint, Jackie MacDonald Gibson and associates said in a statement on Eurekalert.

Data for the study came from Wake County, N.C., which includes rural areas, wealthy exurban developments, and predominantly Black communities. The investigators compared the blood lead levels for children tested between 1998 and 2011 with juvenile delinquency reports of the same children from the N.C. Department of Public Safety.

The main culprit, they found, was well water. Blood lead levels were 11% higher in the children whose water came from private wells, compared with children using community water. About 13% of U.S. households rely on private wells, which are not regulated under the Safe Drinking Water Act, for their water supply.

The researchers said there is an urgent need for better drinking-water solutions in communities that rely on well water, whether it be through subsidized home filtration or infrastructure redevelopment.

An earlier study had estimated that preventing just one child from entering the adult criminal justice system would save $1.3 to $1.5 million in 1997 dollars. That’s about $2.2 to $2.5 million dollars today!

If you do the math, it’s not hard to see what’s cheaper (and healthier) in the long run.
 

A ‘dirty’ scam

Another one? This is just getting sad. You’ve probably heard of muds and clays being good for the skin and maybe you’ve gone to a spa and sat in a mud bath, but would you believe it if someone told you that mud can cure all your ailments? No? Neither would we. Senatorial candidate Beto O’Rourke was definitely someone who brought this strange treatment to light, but it seems like this is something that has been going on for years, even before the pandemic.

Nandan/Pixahive

A company called Black Oxygen Organics (BOO) was selling “magic dirt” for $110 per 4-ounce package. It claimed the dirt was high in fulvic acid and humic acid, which are good for many things. They were, however, literally getting this mud from bogs with landfills nearby, Mel magazine reported.

That doesn’t sound appealing at all, but wait, there’s more. People were eating, drinking, bathing, and feeding their families this sludge in hopes that they would be cured of their ailments. A lot of people jumped aboard the magic dirt train when the pandemic arose, but it quickly became clear that this mud was not as helpful as BOO claimed it to be.

“We began to receive inquiries and calls on our website with people having problems and issues. Ultimately, we sent the products out for independent testing, and then when that came back and showed that there were toxic heavy metals [lead, arsenic, and cadmium among them] at an unsafe level, that’s when we knew we had to act,” Atlanta-based attorney Matt Wetherington, who filed a federal lawsuit against BOO, told Mel.

After a very complicated series of events involving an expose by NBC, product recalls, extortion claims, and grassroots activism, BOO was shut down by both the Canadian and U.S. governments.

As always, please listen only to health care professionals when you wish to use natural remedies for illnesses and ailments.

A Florida doctor told his patient her test result would be available in 3-4 days. When the patient didn’t hear back, she called the practice several times, but she didn’t receive a return call. So she filed a complaint against the doctor with the medical board.

When the board investigator interviewed the doctor, the physician said he wasn’t aware the patient had called. But his staff said otherwise. Because the doctor had not been truthful, the board sent him a letter of guidance and required him to attend a training program in ethics.

Miami attorney William J. Spratt Jr., who supplied this anecdote about a former client, said that most complaints are dismissed with no action taken, but some complaints don’t go away because doctors mishandle them.

The following are some common mistakes that physicians make when dealing with a board complaint.
 

1. Not responding to the complaint

The complaint you get from the board – which often comes with a subpoena and a response deadline – usually asks for medical records pertinent to the case.

You can’t disregard the board’s letter, said Doug Brocker, an attorney handling board actions in Raleigh, N.C. “It’s amazing to me that some people just ignore a board complaint. Sometimes it’s because the doctor is just burnt out, which may have gotten the doctor into trouble in the first place.”

If you do not respond to a subpoena, “the board can file a court order holding you in contempt and start taking action on your license,” said Jeff Segal, MD, a neurosurgeon and attorney in Greensboro, N.C. Dr. Segal is CEO of Medical Justice Services, which protects physicians’ reputations associated with malpractice suits and board actions. “Not responding is not much different from agreeing to all of the charges.”
 

2. Not recognizing the seriousness of the complaint

“The biggest mistake is not taking a complaint seriously,” said Linda Stimmel, an attorney at Wilson Elser in Dallas. “Physicians who get a complaint often fire off a brief response stating that the complaint has no merit, without offering any evidence.”

According to Ms. Stimmel, “it’s really important to back up your assertions, such as using excerpts from the medical record, citations of peer-reviewed articles, or a letter of support from a colleague.”

“Weigh your answers carefully, because lack of accuracy will complicate your case,” Mr. Brocker said. “Consult the medical record rather than rely on your memory.”

“Present your version of events, in your own words, because that’s almost always better than the board’s version,” said Dr. Segal.

Even if there was a bad clinical outcome, Dr. Segal said you might point out that the patient was at high risk, or you could show that your clinical outcomes are better than the national average.
 

3. Thinking the board is on your side

You may be lulled into a false sense of security because the physicians on the medical board are your peers, but they can be as tough as any medical malpractice judge, said William P. Sullivan, DO, an emergency physician and attorney in Frankfort, Ill.

As per the National Practitioner Data Bank, physicians are three to four times more likely to incur an adverse board action than make a malpractice payout, Dr. Sullivan said.

Also, although a malpractice lawsuit rarely involves more than a monetary payment, a board action, like a monitoring plan, can restrict your ability to practice medicine. In fact, any kind of board action against you can make it harder to find employment.
 

4. Not being honest or forthcoming

“Lying to the board is the fastest way to turn what would have been a minor infraction into putting your license at risk,” Mr. Brocker said. This can happen when doctors update a medical record to support their version of events.

As per Dr. Sullivan, another way to put your license at risk is to withhold adverse information, which the board can detect by obtaining your application for hospital privileges or for licensure to another state, in which you revealed the adverse information.

Dr. Sullivan also advised against claiming you “always” take a certain precautionary measure. “In reality, we doctors don’t always do what we would like to have done. By saying you always do it when you didn’t, you appear less than truthful to the board, and boards have a hard time with that.”

Similarly, “when doctors don’t want to recognize that they could have handled things better, they tend to dance around the issue,” Mr. Brocker said. “This does not sit well with the board.” Insisting that you did everything right when it’s obvious that you didn’t can lead to harsher sanctions. “The board wants to make sure doctors recognize their mistakes and are willing to learn from them.”
 

5. Providing too much information

You may think that providing a great deal of information strengthens your case, but it can actually weaken it, Mr. Brocker said. Irrelevant information makes your response hard to follow, and it may contain evidence that could prompt another line of inquiry.

“Less is more,” Dr. Segal advised. “Present a coherent argument and keep to the most salient points.” Being concise is also good advice if your complaint proceeds to the board and you have to present your case.

Dr. Segal said the board will stop paying attention to long-winded presentations. He tells his clients to imagine the board is watching a movie. “If your presentation is tedious or hard to follow, you will lose them.”
 

6. Trying to contact the complainant

Complaints are kept anonymous, but in many cases, the doctor has an idea who the complainant was and may try to contact that person. “It’s natural to wonder why a patient would file a complaint against you,” Mr. Brocker said, but if you reach out to the patient to ask why, “it could look like you’re trying to persuade the patient to drop the complaint.”

Doctors who are involved in a practice breakup or a divorce can be victims of false and malicious complaints, but Beth Y. Collis, a partner at the law firm of Dinsmore & Shohl in Columbus, said boards are onto this tactic and usually reject these complaints.

The doctor may be tempted to sue the complainant, but Mr. Brocker said this won’t stop the complaint and could strengthen it. “Most statements to the medical board are protected from defamation lawsuits, and any lawsuit could appear to be intimidation.”
 

7. Simply signing a consent agreement

A small minority of complaints may result in the board taking action against the doctor. Typically, this involves getting the doctor to sign a consent agreement stating that he or she agrees with the board’s decision and its remedy, such as continuing education, a fine, or being placed under another doctor’s supervision.

“When the board sends you a consent agreement, it’s usually about something fairly minor,” Ms. Collis said. “You can make a counteroffer and see if they accept that. But once you enter into the agreement, you waive any right to appeal the board’s decision.”
 

8. Not hiring an attorney

Although some doctors manage to deal with a board complaint on their own, many will need to get an attorney, Mr. Brocker said. “An experienced attorney can help you navigate the board’s process.”

Clients often look for attorneys at the end of the process, when formal charges have already been filed, Mr. Brocker said. At that point, “it’s harder to get things moving in the right direction. You can’t unring the bell.”

Even if you don’t think you need an attorney throughout the case, “it helps to get advice from an attorney at the beginning,” Dr. Segal said. Doctors may think they can’t afford an attorney, but many malpractice carriers pay attorneys’ fees in medical board investigations.

Mr. Brocker advised finding an attorney who is familiar with licensing boards. “Malpractice attorneys may think they can deal with medical boards, but boards are quite different.” For example, “malpractice cases involve an adversarial approach, but licensing boards normally require working collaboratively.”
 

9. Not requesting a hearing

When the board takes action against you, it can be tempting to just accept the allegations and move on with your life, but it may be possible to undo the action, Dr. Sullivan said. “The board still has to prove its allegations, and it may not have a strong case against you.”

In some states, the medical board has to meet a very high standard of proof, Dr. Sullivan said. In Illinois, for example, the board must show “clear and convincing evidence,” while a malpractice plaintiff must only prove that it’s “more likely than not” that a physician violated the standard of care.

A hearing can especially help doctors facing harsh sanctions for minor offenses. For example, in a case handled by the law firm of Ray & Bishop in Newport Beach, Calif., a doctor who was stopped by police while driving home after having wine at a family gathering was found to have a blood alcohol level of 0.11%. Noting that the physician was on call at the time, the Medical Board of California decided to give him 5 years of probation.

Ray & Bishop asked for a judicial hearing to contest the decision. At the hearing, the physician noted that other physicians were also available to take call that night, and an expert stated that the doctor was not an alcohol abuser. The judge ruled that the board’s action was unduly harsh, and the physician received a public reprimand with no further penalties.
 

10. Getting upset with board officials

A board investigator may show up at your office uninvited and ask you to answer some questions, but you aren’t required to answer then and there, said Ms. Collis.

In fact, she noted, it’s never a good idea to let investigators into your office. “They can walk around, look through your records, and find more things to investigate.” For this reason, Ms. Collis makes it a point to schedule meetings with investigators at her office.

When you have to interact with board officials, such as during hearings, expressing anger is a mistake. “Some board members may raise their voices and make untrue assertions about your medical care,” Dr. Sullivan said. “You may wish you could respond in kind, but that will not help you.” Instead, calmly provide studies or guidelines supporting the care you provided.

Taking board investigators to task is also a mistake, Mr. Brocker pointed out. In his words, “investigators have to follow the rules. Getting mad at them will only make your case more difficult. Even if you believe the complaint against you is totally without merit, the process needs to run its course.”

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

A Florida doctor told his patient her test result would be available in 3-4 days. When the patient didn’t hear back, she called the practice several times, but she didn’t receive a return call. So she filed a complaint against the doctor with the medical board.

When the board investigator interviewed the doctor, the physician said he wasn’t aware the patient had called. But his staff said otherwise. Because the doctor had not been truthful, the board sent him a letter of guidance and required him to attend a training program in ethics.

Miami attorney William J. Spratt Jr., who supplied this anecdote about a former client, said that most complaints are dismissed with no action taken, but some complaints don’t go away because doctors mishandle them.

The following are some common mistakes that physicians make when dealing with a board complaint.
 

1. Not responding to the complaint

The complaint you get from the board – which often comes with a subpoena and a response deadline – usually asks for medical records pertinent to the case.

You can’t disregard the board’s letter, said Doug Brocker, an attorney handling board actions in Raleigh, N.C. “It’s amazing to me that some people just ignore a board complaint. Sometimes it’s because the doctor is just burnt out, which may have gotten the doctor into trouble in the first place.”

If you do not respond to a subpoena, “the board can file a court order holding you in contempt and start taking action on your license,” said Jeff Segal, MD, a neurosurgeon and attorney in Greensboro, N.C. Dr. Segal is CEO of Medical Justice Services, which protects physicians’ reputations associated with malpractice suits and board actions. “Not responding is not much different from agreeing to all of the charges.”
 

2. Not recognizing the seriousness of the complaint

“The biggest mistake is not taking a complaint seriously,” said Linda Stimmel, an attorney at Wilson Elser in Dallas. “Physicians who get a complaint often fire off a brief response stating that the complaint has no merit, without offering any evidence.”

According to Ms. Stimmel, “it’s really important to back up your assertions, such as using excerpts from the medical record, citations of peer-reviewed articles, or a letter of support from a colleague.”

“Weigh your answers carefully, because lack of accuracy will complicate your case,” Mr. Brocker said. “Consult the medical record rather than rely on your memory.”

“Present your version of events, in your own words, because that’s almost always better than the board’s version,” said Dr. Segal.

Even if there was a bad clinical outcome, Dr. Segal said you might point out that the patient was at high risk, or you could show that your clinical outcomes are better than the national average.
 

3. Thinking the board is on your side

You may be lulled into a false sense of security because the physicians on the medical board are your peers, but they can be as tough as any medical malpractice judge, said William P. Sullivan, DO, an emergency physician and attorney in Frankfort, Ill.

As per the National Practitioner Data Bank, physicians are three to four times more likely to incur an adverse board action than make a malpractice payout, Dr. Sullivan said.

Also, although a malpractice lawsuit rarely involves more than a monetary payment, a board action, like a monitoring plan, can restrict your ability to practice medicine. In fact, any kind of board action against you can make it harder to find employment.
 

4. Not being honest or forthcoming

“Lying to the board is the fastest way to turn what would have been a minor infraction into putting your license at risk,” Mr. Brocker said. This can happen when doctors update a medical record to support their version of events.

As per Dr. Sullivan, another way to put your license at risk is to withhold adverse information, which the board can detect by obtaining your application for hospital privileges or for licensure to another state, in which you revealed the adverse information.

Dr. Sullivan also advised against claiming you “always” take a certain precautionary measure. “In reality, we doctors don’t always do what we would like to have done. By saying you always do it when you didn’t, you appear less than truthful to the board, and boards have a hard time with that.”

Similarly, “when doctors don’t want to recognize that they could have handled things better, they tend to dance around the issue,” Mr. Brocker said. “This does not sit well with the board.” Insisting that you did everything right when it’s obvious that you didn’t can lead to harsher sanctions. “The board wants to make sure doctors recognize their mistakes and are willing to learn from them.”
 

5. Providing too much information

You may think that providing a great deal of information strengthens your case, but it can actually weaken it, Mr. Brocker said. Irrelevant information makes your response hard to follow, and it may contain evidence that could prompt another line of inquiry.

“Less is more,” Dr. Segal advised. “Present a coherent argument and keep to the most salient points.” Being concise is also good advice if your complaint proceeds to the board and you have to present your case.

Dr. Segal said the board will stop paying attention to long-winded presentations. He tells his clients to imagine the board is watching a movie. “If your presentation is tedious or hard to follow, you will lose them.”
 

6. Trying to contact the complainant

Complaints are kept anonymous, but in many cases, the doctor has an idea who the complainant was and may try to contact that person. “It’s natural to wonder why a patient would file a complaint against you,” Mr. Brocker said, but if you reach out to the patient to ask why, “it could look like you’re trying to persuade the patient to drop the complaint.”

Doctors who are involved in a practice breakup or a divorce can be victims of false and malicious complaints, but Beth Y. Collis, a partner at the law firm of Dinsmore & Shohl in Columbus, said boards are onto this tactic and usually reject these complaints.

The doctor may be tempted to sue the complainant, but Mr. Brocker said this won’t stop the complaint and could strengthen it. “Most statements to the medical board are protected from defamation lawsuits, and any lawsuit could appear to be intimidation.”
 

7. Simply signing a consent agreement

A small minority of complaints may result in the board taking action against the doctor. Typically, this involves getting the doctor to sign a consent agreement stating that he or she agrees with the board’s decision and its remedy, such as continuing education, a fine, or being placed under another doctor’s supervision.

“When the board sends you a consent agreement, it’s usually about something fairly minor,” Ms. Collis said. “You can make a counteroffer and see if they accept that. But once you enter into the agreement, you waive any right to appeal the board’s decision.”
 

8. Not hiring an attorney

Although some doctors manage to deal with a board complaint on their own, many will need to get an attorney, Mr. Brocker said. “An experienced attorney can help you navigate the board’s process.”

Clients often look for attorneys at the end of the process, when formal charges have already been filed, Mr. Brocker said. At that point, “it’s harder to get things moving in the right direction. You can’t unring the bell.”

Even if you don’t think you need an attorney throughout the case, “it helps to get advice from an attorney at the beginning,” Dr. Segal said. Doctors may think they can’t afford an attorney, but many malpractice carriers pay attorneys’ fees in medical board investigations.

Mr. Brocker advised finding an attorney who is familiar with licensing boards. “Malpractice attorneys may think they can deal with medical boards, but boards are quite different.” For example, “malpractice cases involve an adversarial approach, but licensing boards normally require working collaboratively.”
 

9. Not requesting a hearing

When the board takes action against you, it can be tempting to just accept the allegations and move on with your life, but it may be possible to undo the action, Dr. Sullivan said. “The board still has to prove its allegations, and it may not have a strong case against you.”

In some states, the medical board has to meet a very high standard of proof, Dr. Sullivan said. In Illinois, for example, the board must show “clear and convincing evidence,” while a malpractice plaintiff must only prove that it’s “more likely than not” that a physician violated the standard of care.

A hearing can especially help doctors facing harsh sanctions for minor offenses. For example, in a case handled by the law firm of Ray & Bishop in Newport Beach, Calif., a doctor who was stopped by police while driving home after having wine at a family gathering was found to have a blood alcohol level of 0.11%. Noting that the physician was on call at the time, the Medical Board of California decided to give him 5 years of probation.

Ray & Bishop asked for a judicial hearing to contest the decision. At the hearing, the physician noted that other physicians were also available to take call that night, and an expert stated that the doctor was not an alcohol abuser. The judge ruled that the board’s action was unduly harsh, and the physician received a public reprimand with no further penalties.
 

10. Getting upset with board officials

A board investigator may show up at your office uninvited and ask you to answer some questions, but you aren’t required to answer then and there, said Ms. Collis.

In fact, she noted, it’s never a good idea to let investigators into your office. “They can walk around, look through your records, and find more things to investigate.” For this reason, Ms. Collis makes it a point to schedule meetings with investigators at her office.

When you have to interact with board officials, such as during hearings, expressing anger is a mistake. “Some board members may raise their voices and make untrue assertions about your medical care,” Dr. Sullivan said. “You may wish you could respond in kind, but that will not help you.” Instead, calmly provide studies or guidelines supporting the care you provided.

Taking board investigators to task is also a mistake, Mr. Brocker pointed out. In his words, “investigators have to follow the rules. Getting mad at them will only make your case more difficult. Even if you believe the complaint against you is totally without merit, the process needs to run its course.”

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

A Florida doctor told his patient her test result would be available in 3-4 days. When the patient didn’t hear back, she called the practice several times, but she didn’t receive a return call. So she filed a complaint against the doctor with the medical board.

When the board investigator interviewed the doctor, the physician said he wasn’t aware the patient had called. But his staff said otherwise. Because the doctor had not been truthful, the board sent him a letter of guidance and required him to attend a training program in ethics.

Miami attorney William J. Spratt Jr., who supplied this anecdote about a former client, said that most complaints are dismissed with no action taken, but some complaints don’t go away because doctors mishandle them.

The following are some common mistakes that physicians make when dealing with a board complaint.
 

1. Not responding to the complaint

The complaint you get from the board – which often comes with a subpoena and a response deadline – usually asks for medical records pertinent to the case.

You can’t disregard the board’s letter, said Doug Brocker, an attorney handling board actions in Raleigh, N.C. “It’s amazing to me that some people just ignore a board complaint. Sometimes it’s because the doctor is just burnt out, which may have gotten the doctor into trouble in the first place.”

If you do not respond to a subpoena, “the board can file a court order holding you in contempt and start taking action on your license,” said Jeff Segal, MD, a neurosurgeon and attorney in Greensboro, N.C. Dr. Segal is CEO of Medical Justice Services, which protects physicians’ reputations associated with malpractice suits and board actions. “Not responding is not much different from agreeing to all of the charges.”
 

2. Not recognizing the seriousness of the complaint

“The biggest mistake is not taking a complaint seriously,” said Linda Stimmel, an attorney at Wilson Elser in Dallas. “Physicians who get a complaint often fire off a brief response stating that the complaint has no merit, without offering any evidence.”

According to Ms. Stimmel, “it’s really important to back up your assertions, such as using excerpts from the medical record, citations of peer-reviewed articles, or a letter of support from a colleague.”

“Weigh your answers carefully, because lack of accuracy will complicate your case,” Mr. Brocker said. “Consult the medical record rather than rely on your memory.”

“Present your version of events, in your own words, because that’s almost always better than the board’s version,” said Dr. Segal.

Even if there was a bad clinical outcome, Dr. Segal said you might point out that the patient was at high risk, or you could show that your clinical outcomes are better than the national average.
 

3. Thinking the board is on your side

You may be lulled into a false sense of security because the physicians on the medical board are your peers, but they can be as tough as any medical malpractice judge, said William P. Sullivan, DO, an emergency physician and attorney in Frankfort, Ill.

As per the National Practitioner Data Bank, physicians are three to four times more likely to incur an adverse board action than make a malpractice payout, Dr. Sullivan said.

Also, although a malpractice lawsuit rarely involves more than a monetary payment, a board action, like a monitoring plan, can restrict your ability to practice medicine. In fact, any kind of board action against you can make it harder to find employment.
 

4. Not being honest or forthcoming

“Lying to the board is the fastest way to turn what would have been a minor infraction into putting your license at risk,” Mr. Brocker said. This can happen when doctors update a medical record to support their version of events.

As per Dr. Sullivan, another way to put your license at risk is to withhold adverse information, which the board can detect by obtaining your application for hospital privileges or for licensure to another state, in which you revealed the adverse information.

Dr. Sullivan also advised against claiming you “always” take a certain precautionary measure. “In reality, we doctors don’t always do what we would like to have done. By saying you always do it when you didn’t, you appear less than truthful to the board, and boards have a hard time with that.”

Similarly, “when doctors don’t want to recognize that they could have handled things better, they tend to dance around the issue,” Mr. Brocker said. “This does not sit well with the board.” Insisting that you did everything right when it’s obvious that you didn’t can lead to harsher sanctions. “The board wants to make sure doctors recognize their mistakes and are willing to learn from them.”
 

5. Providing too much information

You may think that providing a great deal of information strengthens your case, but it can actually weaken it, Mr. Brocker said. Irrelevant information makes your response hard to follow, and it may contain evidence that could prompt another line of inquiry.

“Less is more,” Dr. Segal advised. “Present a coherent argument and keep to the most salient points.” Being concise is also good advice if your complaint proceeds to the board and you have to present your case.

Dr. Segal said the board will stop paying attention to long-winded presentations. He tells his clients to imagine the board is watching a movie. “If your presentation is tedious or hard to follow, you will lose them.”
 

6. Trying to contact the complainant

Complaints are kept anonymous, but in many cases, the doctor has an idea who the complainant was and may try to contact that person. “It’s natural to wonder why a patient would file a complaint against you,” Mr. Brocker said, but if you reach out to the patient to ask why, “it could look like you’re trying to persuade the patient to drop the complaint.”

Doctors who are involved in a practice breakup or a divorce can be victims of false and malicious complaints, but Beth Y. Collis, a partner at the law firm of Dinsmore & Shohl in Columbus, said boards are onto this tactic and usually reject these complaints.

The doctor may be tempted to sue the complainant, but Mr. Brocker said this won’t stop the complaint and could strengthen it. “Most statements to the medical board are protected from defamation lawsuits, and any lawsuit could appear to be intimidation.”
 

7. Simply signing a consent agreement

A small minority of complaints may result in the board taking action against the doctor. Typically, this involves getting the doctor to sign a consent agreement stating that he or she agrees with the board’s decision and its remedy, such as continuing education, a fine, or being placed under another doctor’s supervision.

“When the board sends you a consent agreement, it’s usually about something fairly minor,” Ms. Collis said. “You can make a counteroffer and see if they accept that. But once you enter into the agreement, you waive any right to appeal the board’s decision.”
 

8. Not hiring an attorney

Although some doctors manage to deal with a board complaint on their own, many will need to get an attorney, Mr. Brocker said. “An experienced attorney can help you navigate the board’s process.”

Clients often look for attorneys at the end of the process, when formal charges have already been filed, Mr. Brocker said. At that point, “it’s harder to get things moving in the right direction. You can’t unring the bell.”

Even if you don’t think you need an attorney throughout the case, “it helps to get advice from an attorney at the beginning,” Dr. Segal said. Doctors may think they can’t afford an attorney, but many malpractice carriers pay attorneys’ fees in medical board investigations.

Mr. Brocker advised finding an attorney who is familiar with licensing boards. “Malpractice attorneys may think they can deal with medical boards, but boards are quite different.” For example, “malpractice cases involve an adversarial approach, but licensing boards normally require working collaboratively.”
 

9. Not requesting a hearing

When the board takes action against you, it can be tempting to just accept the allegations and move on with your life, but it may be possible to undo the action, Dr. Sullivan said. “The board still has to prove its allegations, and it may not have a strong case against you.”

In some states, the medical board has to meet a very high standard of proof, Dr. Sullivan said. In Illinois, for example, the board must show “clear and convincing evidence,” while a malpractice plaintiff must only prove that it’s “more likely than not” that a physician violated the standard of care.

A hearing can especially help doctors facing harsh sanctions for minor offenses. For example, in a case handled by the law firm of Ray & Bishop in Newport Beach, Calif., a doctor who was stopped by police while driving home after having wine at a family gathering was found to have a blood alcohol level of 0.11%. Noting that the physician was on call at the time, the Medical Board of California decided to give him 5 years of probation.

Ray & Bishop asked for a judicial hearing to contest the decision. At the hearing, the physician noted that other physicians were also available to take call that night, and an expert stated that the doctor was not an alcohol abuser. The judge ruled that the board’s action was unduly harsh, and the physician received a public reprimand with no further penalties.
 

10. Getting upset with board officials

A board investigator may show up at your office uninvited and ask you to answer some questions, but you aren’t required to answer then and there, said Ms. Collis.

In fact, she noted, it’s never a good idea to let investigators into your office. “They can walk around, look through your records, and find more things to investigate.” For this reason, Ms. Collis makes it a point to schedule meetings with investigators at her office.

When you have to interact with board officials, such as during hearings, expressing anger is a mistake. “Some board members may raise their voices and make untrue assertions about your medical care,” Dr. Sullivan said. “You may wish you could respond in kind, but that will not help you.” Instead, calmly provide studies or guidelines supporting the care you provided.

Taking board investigators to task is also a mistake, Mr. Brocker pointed out. In his words, “investigators have to follow the rules. Getting mad at them will only make your case more difficult. Even if you believe the complaint against you is totally without merit, the process needs to run its course.”

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