Eating disorders are a common comorbidity in bipolar disorder patients, especially those with type II, based on data from more than 2,000 individuals.

Previous research of bipolar disorder (BD) shows a high rate of comorbidities with other psychiatric disorders, including eating disorders (EDs), Valentin Flaudias, PhD, of Nantes (France) University and colleagues wrote.

Valentin Flaudias

“There is growing evidence that, compared with individuals with BD alone, individuals with both BD and EDs have a more severe clinical profile, including increased mood instability, alcohol use disorders, anxiety disorders, more depressive episodes, more rapid cycling, increased suicidality, and poorer response to medication,” but studies of BD type-specific ED prevalence have been inconsistent, they said.

In a study published in the Journal of Affective Disorders, the researchers reviewed data from 2,929 outpatients who underwent assessments for BD at 1 of 12 psychiatric centers in France. Of these, 1,505 met criteria for type I and 1,424 met criteria for type II. The post hoc analysis included identification of lifetime prevalence of ED. Diagnosis was based on the DSM-4-TR and the researchers considered three ED types: anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED). Subtypes of BD were type I and type II. DSM not otherwise specified diagnoses for BD and EDs were excluded. The mean age of the participants was 40.5 years, and 61% were women.

A total of 479 individuals met criteria for comorbid EDs (16.4%). ED prevalence was significantly higher in BD type II patients than in BD type I patients (20.6 % vs. 12.4 %, P < .001). The overall breakdown according to ED subtype was 30% for AN, 13% for BN, and 56% for BED. The researchers found no significant differences in patients with AN, BN, or BED according to BD subtype.

In a multivariate analysis, BD patients with ED were more likely than those without ED to be women (77% vs. 55%), especially those with AN (95% vs. 82%).

BD patients with ED also tended to be younger than those without ED (37 years vs. 41 years) and reported more frequent suicide attempts (50% vs. 35%). Younger age and more frequent suicide attempts were further significant among BD patients with AN, compared with those with BED, but BD patients with BED reported higher levels of childhood trauma.

BD patients with ED also reported higher levels of depressive symptoms than those without ED, although history of psychosis was less frequent among BD patients with AN and BED compared with BD patients without EDs.

Overall, “after controlling for other variables, the independent factors differentiating BD patients with versus without ED were primarily younger age, female gender, abnormal BMI, increased affective lability and higher comorbidity with anxiety disorders,” the researchers wrote. In addition, presence of EDs except for AN was associated with decreased current functioning.

The findings were limited by several factors including the cross-sectional design, lack of a control group of non-BD individuals, and the consideration of ED over a lifetime, and small number of BN cases, the researchers noted.

However, the results suggest a high prevalence of ED in BD patients and highlight the need to screen BD patients for ED and provide integrated care. More research is needed to explore the evolution of the two conditions as comorbidities and to examine subtypes and of both conditions and their interactions, they concluded.

The study was supported by the FondaMental Foundation, French National Institute for Health and Medical Research, Public Hospitals of Paris, and the French National Research Agency’s Investment for the Future program. The researchers had no financial conflicts to disclose.

Eating disorders are a common comorbidity in bipolar disorder patients, especially those with type II, based on data from more than 2,000 individuals.

Previous research of bipolar disorder (BD) shows a high rate of comorbidities with other psychiatric disorders, including eating disorders (EDs), Valentin Flaudias, PhD, of Nantes (France) University and colleagues wrote.

Valentin Flaudias

“There is growing evidence that, compared with individuals with BD alone, individuals with both BD and EDs have a more severe clinical profile, including increased mood instability, alcohol use disorders, anxiety disorders, more depressive episodes, more rapid cycling, increased suicidality, and poorer response to medication,” but studies of BD type-specific ED prevalence have been inconsistent, they said.

In a study published in the Journal of Affective Disorders, the researchers reviewed data from 2,929 outpatients who underwent assessments for BD at 1 of 12 psychiatric centers in France. Of these, 1,505 met criteria for type I and 1,424 met criteria for type II. The post hoc analysis included identification of lifetime prevalence of ED. Diagnosis was based on the DSM-4-TR and the researchers considered three ED types: anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED). Subtypes of BD were type I and type II. DSM not otherwise specified diagnoses for BD and EDs were excluded. The mean age of the participants was 40.5 years, and 61% were women.

A total of 479 individuals met criteria for comorbid EDs (16.4%). ED prevalence was significantly higher in BD type II patients than in BD type I patients (20.6 % vs. 12.4 %, P < .001). The overall breakdown according to ED subtype was 30% for AN, 13% for BN, and 56% for BED. The researchers found no significant differences in patients with AN, BN, or BED according to BD subtype.

In a multivariate analysis, BD patients with ED were more likely than those without ED to be women (77% vs. 55%), especially those with AN (95% vs. 82%).

BD patients with ED also tended to be younger than those without ED (37 years vs. 41 years) and reported more frequent suicide attempts (50% vs. 35%). Younger age and more frequent suicide attempts were further significant among BD patients with AN, compared with those with BED, but BD patients with BED reported higher levels of childhood trauma.

BD patients with ED also reported higher levels of depressive symptoms than those without ED, although history of psychosis was less frequent among BD patients with AN and BED compared with BD patients without EDs.

Overall, “after controlling for other variables, the independent factors differentiating BD patients with versus without ED were primarily younger age, female gender, abnormal BMI, increased affective lability and higher comorbidity with anxiety disorders,” the researchers wrote. In addition, presence of EDs except for AN was associated with decreased current functioning.

The findings were limited by several factors including the cross-sectional design, lack of a control group of non-BD individuals, and the consideration of ED over a lifetime, and small number of BN cases, the researchers noted.

However, the results suggest a high prevalence of ED in BD patients and highlight the need to screen BD patients for ED and provide integrated care. More research is needed to explore the evolution of the two conditions as comorbidities and to examine subtypes and of both conditions and their interactions, they concluded.

The study was supported by the FondaMental Foundation, French National Institute for Health and Medical Research, Public Hospitals of Paris, and the French National Research Agency’s Investment for the Future program. The researchers had no financial conflicts to disclose.

Eating disorders are a common comorbidity in bipolar disorder patients, especially those with type II, based on data from more than 2,000 individuals.

Previous research of bipolar disorder (BD) shows a high rate of comorbidities with other psychiatric disorders, including eating disorders (EDs), Valentin Flaudias, PhD, of Nantes (France) University and colleagues wrote.

Valentin Flaudias

“There is growing evidence that, compared with individuals with BD alone, individuals with both BD and EDs have a more severe clinical profile, including increased mood instability, alcohol use disorders, anxiety disorders, more depressive episodes, more rapid cycling, increased suicidality, and poorer response to medication,” but studies of BD type-specific ED prevalence have been inconsistent, they said.

In a study published in the Journal of Affective Disorders, the researchers reviewed data from 2,929 outpatients who underwent assessments for BD at 1 of 12 psychiatric centers in France. Of these, 1,505 met criteria for type I and 1,424 met criteria for type II. The post hoc analysis included identification of lifetime prevalence of ED. Diagnosis was based on the DSM-4-TR and the researchers considered three ED types: anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED). Subtypes of BD were type I and type II. DSM not otherwise specified diagnoses for BD and EDs were excluded. The mean age of the participants was 40.5 years, and 61% were women.

A total of 479 individuals met criteria for comorbid EDs (16.4%). ED prevalence was significantly higher in BD type II patients than in BD type I patients (20.6 % vs. 12.4 %, P < .001). The overall breakdown according to ED subtype was 30% for AN, 13% for BN, and 56% for BED. The researchers found no significant differences in patients with AN, BN, or BED according to BD subtype.

In a multivariate analysis, BD patients with ED were more likely than those without ED to be women (77% vs. 55%), especially those with AN (95% vs. 82%).

BD patients with ED also tended to be younger than those without ED (37 years vs. 41 years) and reported more frequent suicide attempts (50% vs. 35%). Younger age and more frequent suicide attempts were further significant among BD patients with AN, compared with those with BED, but BD patients with BED reported higher levels of childhood trauma.

BD patients with ED also reported higher levels of depressive symptoms than those without ED, although history of psychosis was less frequent among BD patients with AN and BED compared with BD patients without EDs.

Overall, “after controlling for other variables, the independent factors differentiating BD patients with versus without ED were primarily younger age, female gender, abnormal BMI, increased affective lability and higher comorbidity with anxiety disorders,” the researchers wrote. In addition, presence of EDs except for AN was associated with decreased current functioning.

The findings were limited by several factors including the cross-sectional design, lack of a control group of non-BD individuals, and the consideration of ED over a lifetime, and small number of BN cases, the researchers noted.

However, the results suggest a high prevalence of ED in BD patients and highlight the need to screen BD patients for ED and provide integrated care. More research is needed to explore the evolution of the two conditions as comorbidities and to examine subtypes and of both conditions and their interactions, they concluded.

The study was supported by the FondaMental Foundation, French National Institute for Health and Medical Research, Public Hospitals of Paris, and the French National Research Agency’s Investment for the Future program. The researchers had no financial conflicts to disclose.

Michael Victoroff, MD, described the phone call he received from an attorney asking a thorny ethics question involving a patient’s gift to another physician. Dr. Victoroff, a past member of the ethics committee of the American Academy of Family Physicians, had definite thoughts about it.

“The attorney was representing the daughters of an elderly gentleman who had moved from the East Coast to Colorado to be closer to them,” said Dr. Victoroff, who teaches bioethics in the MBA program at the University of Denver and also practices at the University of Colorado School of Medicine.

“The father visited his new primary care physician frequently because he had multiple health issues.”

The patient was happy with the doctor’s medical care and over time that they developed a friendship. Dr. Victoroff emphasized that no sexual or romantic impropriety ever took place between the patient and his physician.

“But the social relationship went beyond the ordinary doctor-patient boundaries. The patient ultimately named the doctor as his health care proxy in the event that he became unable to make decisions regarding his care. He also mentioned he was going to leave her $100,000 in his will,” says Dr. Victoroff.

The physician did accept the role of proxy, “which raises a whole host of ethical issues,” says Dr. Victoroff. As it happened, she was never called upon to exercise that decision-making authority, since the patient died suddenly and was mentally competent at the time.

After his death, his daughters became aware of the large sum of money he had bequeathed to his doctor. They felt it was unethical for her to accept such a substantial bequest from a patient, and they hired an attorney to contest the will.
 

No law against it

Dennis Hursh, attorney and managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, noted in an interview that, “the problem isn’t legal per se. Rather, the problem is an ethical one.”

Legally speaking, there’s no prohibition against receiving a bequest or other form of gift from a patient. “People are free to dispose of their estates in whatever way they see fit, and no law technically precludes a physician from accepting a bequest,” says Dr. Victoroff. “But this presupposes there is nothing improper going on, such as extortion, deception, coercion, or exercising undue influence.”

The issue of bequeathing money to their physician gained attention in a recent case that took place in Australia. Peter Alexakis, MD, received a whopping bequest of $24 million from a patient. The elderly patient had changed his will to name Dr. Alexakis as the sole beneficiary – after Dr. Alexakis had visited him at home 92 times during the preceding months. The original heirs filed a lawsuit in Australia’s Supreme Court against Dr. Alexakis, contesting the will.

The lawsuit was unsuccessful in court, but Dr. Alexakis was found guilty of malpractice by Australia’s Health Care Complaints Commission after being reported to the HCCC by the palliative care physicians who were treating the patient. They alleged that Dr. Alexakis had interfered with their care of the patient. The more serious allegation was that the doctor had engaged in a deliberate strategy to exploit the relationship for financial gain.

Dr. Alexakis was chastised by the HCCC for engaging in “obtuse” and “suspicious” behavior and for “blurring the boundaries of the doctor-patient relationship.”

There are three domains – legal, ethical, and practical – when it comes to accepting bequests or any gifts from patients, says Dr. Victoroff.

“[In] the legal domain, for example, if you receive a bequest from anyone, patient or otherwise, you have to know your local laws about estates and taxes and so forth and obey them,” he said.

Attorney Hursh pointed out that the Australian doctor wasn’t found guilty of wrongdoing in a court of law but rather of unethical conduct by the Australian medical licensing entity.

Patients giving gifts is often a part of a physician’s life

When Ian Schorr, MD, first started out in practice, he was surprised that patients began bringing him gifts of food to express gratitude for his care.

“I thought it was unethical to accept their gifts, so I turned them down and wouldn’t accept so much as a cookie,” Dr. Schorr, a now-retired ophthalmologist, told this news organization. “But that changed because my office staff told me that some patients were feeling disappointed and insulted. I realized that some people want to express appreciation in ways that go beyond a monetary payment.”

The next time he received a gift from a patient, he “accepted it gracefully.” And he wrote a thank you note, which he continued to do any time he received a gift from a patient.

Kenneth Prager, MD, professor of clinical medicine, director of clinical ethics and chairman of the Medical Ethics Committee at Columbia University Medical Center, New York, says, “I have literally received hundreds of gifts, the vast majority being tokens of patients’ appreciation,” he said. “I’ll get boxes of chocolate or cakes, or sometimes articles of clothing.”

Occasionally, Dr. Prager receives a “somewhat larger gift” – for example, two tickets to a baseball game. “To reject these gifts would be a slap in the face to the patient,” he says, but “where it gets more ethically cloudy is when a gift is very substantial.”

Dr. Prager has never been offered a “substantial” gift or bequest personally. “But a patient whose brother I cared for has indicated that she has left instructions in her will to endow an associate chair of ethics in my honor, and I didn’t decline that,” he said.

The AMA Code of Ethics confirms that accepting gifts offered “as an expression of gratitude or a reflection of the patient’s cultural tradition” can “enhance the patient-physician relationship.” But sometimes gifts “may signal psychological needs that require the physician’s attention.” Accepting such gifts is “likely to damage the patient-physician relationship.”

Potential damage to the therapeutic relationship applies to all physicians but especially for psychiatrists and mental health professionals. “There are more stringent ethical requirements when it comes to these disciplines, where gift-giving gets into the territory of transference or may have particular psychological meaning, and accepting the gift may muddy the therapeutic waters,” Dr. Victoroff said.
 

Impact on the patient’s family and on other patients

The AMA statement encourages physicians to be “sensitive to the gift’s value, relative to the patient’s or physician’s means.” Physicians should decline gifts that are “disproportionately or inappropriately large, or when the physician would be uncomfortable to have colleagues know the gift had been accepted.”

They should also decline a bequest from a patient if they have reason to believe that to accept it “would present an emotional or financial hardship to the patient’s family.”

“If Bill Gates were leaving $100,000 to his doctor, I imagine Melinda would be just fine,” Mr. Hursh said. “But under ordinary circumstances, if the patient’s family might feel the impact of the bequest, it would be unethical to accept it and could be grounds for revocation of the doctor’s license.”

The AMA statement also warns physicians that by offering a gift, some patients may be seeking to “secure or influence care or to secure preferential treatment,” which can “undermine physicians’ obligation to provide services fairly to all patients.”

For this reason, bequests are “sticky,” said Laurel Lyckholm, MD, professor of hematology and oncology at West Virginia University School of Medicine. In the case of institutions where patients or community members donate money, “we know whose names are on the plaques that hang on the hospital walls, so it’s a delicate balance. What if there’s only one bed or one ventilator? Will the wife of the donor get preferential treatment?”
 

Follow institutional policy

A “very small gift, such as a fruitcake, is fine,” says Dr. Lyckholm, author of an essay on accepting gifts from patients. She said there’s a dollar amount ($15) that her institution mandates, above which a gift – even food – is considered too expensive to accept. “I was a nurse before I became a physician, and people always tried to give us gifts because we were so close to the minute-by-minute care of the patients,” she said. “We were not allowed to accept money or anything lavish.”

But in the case of small gifts, “the risk-benefit analysis is that there’s much more risk not to take it and to hurt the patient’s feelings.”

Gifts above $15 are given to charity. “I explain to patients that I’m not allowed to take such a large gift, but I’d love to give it to the hospital’s Rosenbaum Family House that provides patients and their relatives with lodging, or to the homeless shelter in Morgantown.”

Dr. Lyckholm, who serves on the ethics committee at J.W. Ruby Memorial Hospital, once was offered expensive tickets and said to the patient, “This is so incredibly thoughtful and kind, but I can’t accept them. I would like to give the tickets to a charity that can auction them off.”

She advises physicians to find out their institution’s policies. Many institutions have policies about what gifts their staff – whether physicians, nurses, or other health care professionals – can accept.
 

Passing the ‘smell test’

Accepting a large gift from a patient could potentially make it look like you might have exercised undue influence.

“That concern brings us to the third domain, which is very practical and all about appearances and perceptions,” Dr. Victoroff said.

He noted that there is “an inherent power differential between a physician and a patient. The very nature of the relationship can create a risk of ‘undue influence’ on the doctor’s part, even if it’s not apparent to the doctor.” For this reason, it’s necessary to be utterly transparent about how the bequest came about.

He suggests that if a patient informs you that he or she would like to leave money to you, it might be wise to suggest a meeting with the patient’s family, thus establishing some transparency.

It may not be possible to meet with the patient’s family for logistical reasons or because the patient would prefer not to involve their family in their estate planning. But in any case, it’s advisable to document any conversation in the patient’s chart, Dr. Victoroff advised.

“You should make a contemporaneous note that the patient initiated the suggestion and that you counseled them about the implications, no differently than you would with an interaction of a clinical nature,” he suggests. That way, if money has been left to you and is disputed, there’s a clear record that you didn’t solicit it or use any undue influence to bring it about.

He also recommended getting advice from a trusted colleague or a member of your institution’s ethics committee. “Taking time to get a second opinion about an ethical question is a safeguard, like having a chaperone in the room during an examination.”

Ultimately, “there is no human relationship without potential conflicts of interest. Our job is to manage those as best as we can, and sunlight is the best antidote to bad appearances,” Dr. Victoroff said.

A version of this article appeared on Medscape.com.

Michael Victoroff, MD, described the phone call he received from an attorney asking a thorny ethics question involving a patient’s gift to another physician. Dr. Victoroff, a past member of the ethics committee of the American Academy of Family Physicians, had definite thoughts about it.

“The attorney was representing the daughters of an elderly gentleman who had moved from the East Coast to Colorado to be closer to them,” said Dr. Victoroff, who teaches bioethics in the MBA program at the University of Denver and also practices at the University of Colorado School of Medicine.

“The father visited his new primary care physician frequently because he had multiple health issues.”

The patient was happy with the doctor’s medical care and over time that they developed a friendship. Dr. Victoroff emphasized that no sexual or romantic impropriety ever took place between the patient and his physician.

“But the social relationship went beyond the ordinary doctor-patient boundaries. The patient ultimately named the doctor as his health care proxy in the event that he became unable to make decisions regarding his care. He also mentioned he was going to leave her $100,000 in his will,” says Dr. Victoroff.

The physician did accept the role of proxy, “which raises a whole host of ethical issues,” says Dr. Victoroff. As it happened, she was never called upon to exercise that decision-making authority, since the patient died suddenly and was mentally competent at the time.

After his death, his daughters became aware of the large sum of money he had bequeathed to his doctor. They felt it was unethical for her to accept such a substantial bequest from a patient, and they hired an attorney to contest the will.
 

No law against it

Dennis Hursh, attorney and managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, noted in an interview that, “the problem isn’t legal per se. Rather, the problem is an ethical one.”

Legally speaking, there’s no prohibition against receiving a bequest or other form of gift from a patient. “People are free to dispose of their estates in whatever way they see fit, and no law technically precludes a physician from accepting a bequest,” says Dr. Victoroff. “But this presupposes there is nothing improper going on, such as extortion, deception, coercion, or exercising undue influence.”

The issue of bequeathing money to their physician gained attention in a recent case that took place in Australia. Peter Alexakis, MD, received a whopping bequest of $24 million from a patient. The elderly patient had changed his will to name Dr. Alexakis as the sole beneficiary – after Dr. Alexakis had visited him at home 92 times during the preceding months. The original heirs filed a lawsuit in Australia’s Supreme Court against Dr. Alexakis, contesting the will.

The lawsuit was unsuccessful in court, but Dr. Alexakis was found guilty of malpractice by Australia’s Health Care Complaints Commission after being reported to the HCCC by the palliative care physicians who were treating the patient. They alleged that Dr. Alexakis had interfered with their care of the patient. The more serious allegation was that the doctor had engaged in a deliberate strategy to exploit the relationship for financial gain.

Dr. Alexakis was chastised by the HCCC for engaging in “obtuse” and “suspicious” behavior and for “blurring the boundaries of the doctor-patient relationship.”

There are three domains – legal, ethical, and practical – when it comes to accepting bequests or any gifts from patients, says Dr. Victoroff.

“[In] the legal domain, for example, if you receive a bequest from anyone, patient or otherwise, you have to know your local laws about estates and taxes and so forth and obey them,” he said.

Attorney Hursh pointed out that the Australian doctor wasn’t found guilty of wrongdoing in a court of law but rather of unethical conduct by the Australian medical licensing entity.

Patients giving gifts is often a part of a physician’s life

When Ian Schorr, MD, first started out in practice, he was surprised that patients began bringing him gifts of food to express gratitude for his care.

“I thought it was unethical to accept their gifts, so I turned them down and wouldn’t accept so much as a cookie,” Dr. Schorr, a now-retired ophthalmologist, told this news organization. “But that changed because my office staff told me that some patients were feeling disappointed and insulted. I realized that some people want to express appreciation in ways that go beyond a monetary payment.”

The next time he received a gift from a patient, he “accepted it gracefully.” And he wrote a thank you note, which he continued to do any time he received a gift from a patient.

Kenneth Prager, MD, professor of clinical medicine, director of clinical ethics and chairman of the Medical Ethics Committee at Columbia University Medical Center, New York, says, “I have literally received hundreds of gifts, the vast majority being tokens of patients’ appreciation,” he said. “I’ll get boxes of chocolate or cakes, or sometimes articles of clothing.”

Occasionally, Dr. Prager receives a “somewhat larger gift” – for example, two tickets to a baseball game. “To reject these gifts would be a slap in the face to the patient,” he says, but “where it gets more ethically cloudy is when a gift is very substantial.”

Dr. Prager has never been offered a “substantial” gift or bequest personally. “But a patient whose brother I cared for has indicated that she has left instructions in her will to endow an associate chair of ethics in my honor, and I didn’t decline that,” he said.

The AMA Code of Ethics confirms that accepting gifts offered “as an expression of gratitude or a reflection of the patient’s cultural tradition” can “enhance the patient-physician relationship.” But sometimes gifts “may signal psychological needs that require the physician’s attention.” Accepting such gifts is “likely to damage the patient-physician relationship.”

Potential damage to the therapeutic relationship applies to all physicians but especially for psychiatrists and mental health professionals. “There are more stringent ethical requirements when it comes to these disciplines, where gift-giving gets into the territory of transference or may have particular psychological meaning, and accepting the gift may muddy the therapeutic waters,” Dr. Victoroff said.
 

Impact on the patient’s family and on other patients

The AMA statement encourages physicians to be “sensitive to the gift’s value, relative to the patient’s or physician’s means.” Physicians should decline gifts that are “disproportionately or inappropriately large, or when the physician would be uncomfortable to have colleagues know the gift had been accepted.”

They should also decline a bequest from a patient if they have reason to believe that to accept it “would present an emotional or financial hardship to the patient’s family.”

“If Bill Gates were leaving $100,000 to his doctor, I imagine Melinda would be just fine,” Mr. Hursh said. “But under ordinary circumstances, if the patient’s family might feel the impact of the bequest, it would be unethical to accept it and could be grounds for revocation of the doctor’s license.”

The AMA statement also warns physicians that by offering a gift, some patients may be seeking to “secure or influence care or to secure preferential treatment,” which can “undermine physicians’ obligation to provide services fairly to all patients.”

For this reason, bequests are “sticky,” said Laurel Lyckholm, MD, professor of hematology and oncology at West Virginia University School of Medicine. In the case of institutions where patients or community members donate money, “we know whose names are on the plaques that hang on the hospital walls, so it’s a delicate balance. What if there’s only one bed or one ventilator? Will the wife of the donor get preferential treatment?”
 

Follow institutional policy

A “very small gift, such as a fruitcake, is fine,” says Dr. Lyckholm, author of an essay on accepting gifts from patients. She said there’s a dollar amount ($15) that her institution mandates, above which a gift – even food – is considered too expensive to accept. “I was a nurse before I became a physician, and people always tried to give us gifts because we were so close to the minute-by-minute care of the patients,” she said. “We were not allowed to accept money or anything lavish.”

But in the case of small gifts, “the risk-benefit analysis is that there’s much more risk not to take it and to hurt the patient’s feelings.”

Gifts above $15 are given to charity. “I explain to patients that I’m not allowed to take such a large gift, but I’d love to give it to the hospital’s Rosenbaum Family House that provides patients and their relatives with lodging, or to the homeless shelter in Morgantown.”

Dr. Lyckholm, who serves on the ethics committee at J.W. Ruby Memorial Hospital, once was offered expensive tickets and said to the patient, “This is so incredibly thoughtful and kind, but I can’t accept them. I would like to give the tickets to a charity that can auction them off.”

She advises physicians to find out their institution’s policies. Many institutions have policies about what gifts their staff – whether physicians, nurses, or other health care professionals – can accept.
 

Passing the ‘smell test’

Accepting a large gift from a patient could potentially make it look like you might have exercised undue influence.

“That concern brings us to the third domain, which is very practical and all about appearances and perceptions,” Dr. Victoroff said.

He noted that there is “an inherent power differential between a physician and a patient. The very nature of the relationship can create a risk of ‘undue influence’ on the doctor’s part, even if it’s not apparent to the doctor.” For this reason, it’s necessary to be utterly transparent about how the bequest came about.

He suggests that if a patient informs you that he or she would like to leave money to you, it might be wise to suggest a meeting with the patient’s family, thus establishing some transparency.

It may not be possible to meet with the patient’s family for logistical reasons or because the patient would prefer not to involve their family in their estate planning. But in any case, it’s advisable to document any conversation in the patient’s chart, Dr. Victoroff advised.

“You should make a contemporaneous note that the patient initiated the suggestion and that you counseled them about the implications, no differently than you would with an interaction of a clinical nature,” he suggests. That way, if money has been left to you and is disputed, there’s a clear record that you didn’t solicit it or use any undue influence to bring it about.

He also recommended getting advice from a trusted colleague or a member of your institution’s ethics committee. “Taking time to get a second opinion about an ethical question is a safeguard, like having a chaperone in the room during an examination.”

Ultimately, “there is no human relationship without potential conflicts of interest. Our job is to manage those as best as we can, and sunlight is the best antidote to bad appearances,” Dr. Victoroff said.

A version of this article appeared on Medscape.com.

Michael Victoroff, MD, described the phone call he received from an attorney asking a thorny ethics question involving a patient’s gift to another physician. Dr. Victoroff, a past member of the ethics committee of the American Academy of Family Physicians, had definite thoughts about it.

“The attorney was representing the daughters of an elderly gentleman who had moved from the East Coast to Colorado to be closer to them,” said Dr. Victoroff, who teaches bioethics in the MBA program at the University of Denver and also practices at the University of Colorado School of Medicine.

“The father visited his new primary care physician frequently because he had multiple health issues.”

The patient was happy with the doctor’s medical care and over time that they developed a friendship. Dr. Victoroff emphasized that no sexual or romantic impropriety ever took place between the patient and his physician.

“But the social relationship went beyond the ordinary doctor-patient boundaries. The patient ultimately named the doctor as his health care proxy in the event that he became unable to make decisions regarding his care. He also mentioned he was going to leave her $100,000 in his will,” says Dr. Victoroff.

The physician did accept the role of proxy, “which raises a whole host of ethical issues,” says Dr. Victoroff. As it happened, she was never called upon to exercise that decision-making authority, since the patient died suddenly and was mentally competent at the time.

After his death, his daughters became aware of the large sum of money he had bequeathed to his doctor. They felt it was unethical for her to accept such a substantial bequest from a patient, and they hired an attorney to contest the will.
 

No law against it

Dennis Hursh, attorney and managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, noted in an interview that, “the problem isn’t legal per se. Rather, the problem is an ethical one.”

Legally speaking, there’s no prohibition against receiving a bequest or other form of gift from a patient. “People are free to dispose of their estates in whatever way they see fit, and no law technically precludes a physician from accepting a bequest,” says Dr. Victoroff. “But this presupposes there is nothing improper going on, such as extortion, deception, coercion, or exercising undue influence.”

The issue of bequeathing money to their physician gained attention in a recent case that took place in Australia. Peter Alexakis, MD, received a whopping bequest of $24 million from a patient. The elderly patient had changed his will to name Dr. Alexakis as the sole beneficiary – after Dr. Alexakis had visited him at home 92 times during the preceding months. The original heirs filed a lawsuit in Australia’s Supreme Court against Dr. Alexakis, contesting the will.

The lawsuit was unsuccessful in court, but Dr. Alexakis was found guilty of malpractice by Australia’s Health Care Complaints Commission after being reported to the HCCC by the palliative care physicians who were treating the patient. They alleged that Dr. Alexakis had interfered with their care of the patient. The more serious allegation was that the doctor had engaged in a deliberate strategy to exploit the relationship for financial gain.

Dr. Alexakis was chastised by the HCCC for engaging in “obtuse” and “suspicious” behavior and for “blurring the boundaries of the doctor-patient relationship.”

There are three domains – legal, ethical, and practical – when it comes to accepting bequests or any gifts from patients, says Dr. Victoroff.

“[In] the legal domain, for example, if you receive a bequest from anyone, patient or otherwise, you have to know your local laws about estates and taxes and so forth and obey them,” he said.

Attorney Hursh pointed out that the Australian doctor wasn’t found guilty of wrongdoing in a court of law but rather of unethical conduct by the Australian medical licensing entity.

Patients giving gifts is often a part of a physician’s life

When Ian Schorr, MD, first started out in practice, he was surprised that patients began bringing him gifts of food to express gratitude for his care.

“I thought it was unethical to accept their gifts, so I turned them down and wouldn’t accept so much as a cookie,” Dr. Schorr, a now-retired ophthalmologist, told this news organization. “But that changed because my office staff told me that some patients were feeling disappointed and insulted. I realized that some people want to express appreciation in ways that go beyond a monetary payment.”

The next time he received a gift from a patient, he “accepted it gracefully.” And he wrote a thank you note, which he continued to do any time he received a gift from a patient.

Kenneth Prager, MD, professor of clinical medicine, director of clinical ethics and chairman of the Medical Ethics Committee at Columbia University Medical Center, New York, says, “I have literally received hundreds of gifts, the vast majority being tokens of patients’ appreciation,” he said. “I’ll get boxes of chocolate or cakes, or sometimes articles of clothing.”

Occasionally, Dr. Prager receives a “somewhat larger gift” – for example, two tickets to a baseball game. “To reject these gifts would be a slap in the face to the patient,” he says, but “where it gets more ethically cloudy is when a gift is very substantial.”

Dr. Prager has never been offered a “substantial” gift or bequest personally. “But a patient whose brother I cared for has indicated that she has left instructions in her will to endow an associate chair of ethics in my honor, and I didn’t decline that,” he said.

The AMA Code of Ethics confirms that accepting gifts offered “as an expression of gratitude or a reflection of the patient’s cultural tradition” can “enhance the patient-physician relationship.” But sometimes gifts “may signal psychological needs that require the physician’s attention.” Accepting such gifts is “likely to damage the patient-physician relationship.”

Potential damage to the therapeutic relationship applies to all physicians but especially for psychiatrists and mental health professionals. “There are more stringent ethical requirements when it comes to these disciplines, where gift-giving gets into the territory of transference or may have particular psychological meaning, and accepting the gift may muddy the therapeutic waters,” Dr. Victoroff said.
 

Impact on the patient’s family and on other patients

The AMA statement encourages physicians to be “sensitive to the gift’s value, relative to the patient’s or physician’s means.” Physicians should decline gifts that are “disproportionately or inappropriately large, or when the physician would be uncomfortable to have colleagues know the gift had been accepted.”

They should also decline a bequest from a patient if they have reason to believe that to accept it “would present an emotional or financial hardship to the patient’s family.”

“If Bill Gates were leaving $100,000 to his doctor, I imagine Melinda would be just fine,” Mr. Hursh said. “But under ordinary circumstances, if the patient’s family might feel the impact of the bequest, it would be unethical to accept it and could be grounds for revocation of the doctor’s license.”

The AMA statement also warns physicians that by offering a gift, some patients may be seeking to “secure or influence care or to secure preferential treatment,” which can “undermine physicians’ obligation to provide services fairly to all patients.”

For this reason, bequests are “sticky,” said Laurel Lyckholm, MD, professor of hematology and oncology at West Virginia University School of Medicine. In the case of institutions where patients or community members donate money, “we know whose names are on the plaques that hang on the hospital walls, so it’s a delicate balance. What if there’s only one bed or one ventilator? Will the wife of the donor get preferential treatment?”
 

Follow institutional policy

A “very small gift, such as a fruitcake, is fine,” says Dr. Lyckholm, author of an essay on accepting gifts from patients. She said there’s a dollar amount ($15) that her institution mandates, above which a gift – even food – is considered too expensive to accept. “I was a nurse before I became a physician, and people always tried to give us gifts because we were so close to the minute-by-minute care of the patients,” she said. “We were not allowed to accept money or anything lavish.”

But in the case of small gifts, “the risk-benefit analysis is that there’s much more risk not to take it and to hurt the patient’s feelings.”

Gifts above $15 are given to charity. “I explain to patients that I’m not allowed to take such a large gift, but I’d love to give it to the hospital’s Rosenbaum Family House that provides patients and their relatives with lodging, or to the homeless shelter in Morgantown.”

Dr. Lyckholm, who serves on the ethics committee at J.W. Ruby Memorial Hospital, once was offered expensive tickets and said to the patient, “This is so incredibly thoughtful and kind, but I can’t accept them. I would like to give the tickets to a charity that can auction them off.”

She advises physicians to find out their institution’s policies. Many institutions have policies about what gifts their staff – whether physicians, nurses, or other health care professionals – can accept.
 

Passing the ‘smell test’

Accepting a large gift from a patient could potentially make it look like you might have exercised undue influence.

“That concern brings us to the third domain, which is very practical and all about appearances and perceptions,” Dr. Victoroff said.

He noted that there is “an inherent power differential between a physician and a patient. The very nature of the relationship can create a risk of ‘undue influence’ on the doctor’s part, even if it’s not apparent to the doctor.” For this reason, it’s necessary to be utterly transparent about how the bequest came about.

He suggests that if a patient informs you that he or she would like to leave money to you, it might be wise to suggest a meeting with the patient’s family, thus establishing some transparency.

It may not be possible to meet with the patient’s family for logistical reasons or because the patient would prefer not to involve their family in their estate planning. But in any case, it’s advisable to document any conversation in the patient’s chart, Dr. Victoroff advised.

“You should make a contemporaneous note that the patient initiated the suggestion and that you counseled them about the implications, no differently than you would with an interaction of a clinical nature,” he suggests. That way, if money has been left to you and is disputed, there’s a clear record that you didn’t solicit it or use any undue influence to bring it about.

He also recommended getting advice from a trusted colleague or a member of your institution’s ethics committee. “Taking time to get a second opinion about an ethical question is a safeguard, like having a chaperone in the room during an examination.”

Ultimately, “there is no human relationship without potential conflicts of interest. Our job is to manage those as best as we can, and sunlight is the best antidote to bad appearances,” Dr. Victoroff said.

A version of this article appeared on Medscape.com.

AMSTERDAM – Dropping aspirin and using low-dose prasugrel (Effient) alone in the initial month of treatment after percutaneous coronary intervention (PCI) failed to lower bleeding risk, compared with dual antiplatelet therapy (DAPT), and there was a signal of possible harm in terms of increased subacute stent thrombosis, in the STOPDAPT-3 trial.

“Therefore, dual antiplatelet therapy with aspirin and a P2Y12 inhibitor should still remain the standard strategy at least for 1 month after PCI,” said the trial’s lead investigator Masahiro Natsuaki, MD, Saga (Japan) University.

The STOPDAPT-3 trial was presented at the recent annual congress of the European Society of Cardiology.

Designated discussant Marco Valgimigli, MD, Cardiocentro Ticino Foundation, Lugano, Switzerland, explained that the current wisdom before this study was that aspirin withdrawal in the postacute phase after PCI (after 1 month of DAPT onwards) is associated with lower bleeding risk without affecting ischemic risk, but this STOPDAPT-3 trial is the first to look at the idea of not giving aspirin at all.

“This study is a well-designed, well-conducted trial, and the results are very clear: there is no benefit of dropping aspirin in this early period with respect to major bleeding, and at the same time there was some signal for possible harm,” Dr. Valgimigli said.

He pointed out that the possible harm was not related to the coprimary cardiovascular composite endpoint, which did fulfill noninferiority, although he acknowledged the “generous” noninferiority margin.

Rather, the possible harm was related to an increase in subacute stent thrombosis, which was three times higher in the nonaspirin group (0.58% vs. 0.17%). 

“While these absolute event rates are extremely low, they are unquestionably higher in the nonaspirin group,” he added.

In his presentation, Dr. Natsuaki explained that very short durations (1-3 months) of DAPT followed by P2Y12 inhibitor monotherapy has been shown to reduce bleeding events without increasing cardiovascular events, compared with longer durations of DAPT after PCI using drug-eluting stents.

However, the incidence of major bleeding events within the 1-month mandatory DAPT period after PCI remains high in clinical practice, particularly in patients with ACS or high bleeding risk.

In single-arm studies, use of prasugrel or ticagrelor (Brilinta) alone following new-generation drug-eluting stent implantation was not associated with any stent thrombosis in selected low-risk patients with or without ACS, and it is thought that removing aspirin from the DAPT regimen might reduce bleeding events early after PCI without compromising the risk of cardiovascular events. However, the efficacy and safety of this strategy has not been proven in randomized trials.
 

STOPDAPT-3 trial

STOPDAPT-3 investigated the efficacy and safety of prasugrel monotherapy compared with 1-month DAPT with aspirin and prasugrel in Japanese patients with ACS or high bleeding risk undergoing PCI with cobalt-chromium everolimus-eluting stents.

The study enrolled 6,002 patients with ACS or high bleeding risk who were randomly assigned to prasugrel monotherapy (3.75 mg/day; the licensed dose in Japan) or to DAPT with aspirin (81-100 mg/day) and prasugrel after a loading dose of prasugrel 20 mg in both groups.

There were two primary endpoints: major bleeding events (defined as BARC type 3 or 5) at 1 month for superiority and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) at 1 month for noninferiority.

The major secondary endpoint was a composite of the coprimary bleeding and cardiovascular endpoints (cardiovascular death, myocardial infarction, definite stent thrombosis, stroke, or major bleeding) at 1 month representing net clinical benefit.

Results showed that, at 1 month, the no-aspirin strategy was not superior to DAPT for the coprimary bleeding endpoint, with major bleeding events occurring in 4.47% of the prasugrel monotherapy group versus 4.71% of those on DAPT (hazard ratio, 0.95; 95% confidence interval, 0.75-1.20).

The prasugrel monotherapy strategy was noninferior to DAPT, although there was a relative 50% margin for the coprimary cardiovascular endpoint. Cardiovascular endpoints occurred in 4.12% of prasugrel monotherapy group versus 3.69% of the DAPT patients (HR, 1.12; 95% CI, 0.87-1.45; P for noninferiority = .01).

The major secondary net clinical benefit endpoint occurred in 7.14% patients in the prasugrel monotherapy group and 7.38% patients in the DAPT group, with no between-group difference, indicating a similar effect on net clinical benefit for both groups.

However, there was an excess of any coronary revascularization (1.15% vs. 0.57%) and definite or probable stent thrombosis (0.71% vs. 0.44%) in the prasugrel monotherapy group compared with the DAPT group, while definite stent thrombosis was not different between the two groups (0.47% vs. 0.37%).

In a subgroup analysis stratified by ACS and non-ACS, the excess risk for cardiovascular events in the no-aspirin group, compared with the DAPT group, was seen in patients with ACS, but not in those without ACS.
 

Future: Focus on dose and timing

In his discussion, Dr. Valgimigli said the implications of this trial for clinical practice were very clear: “Aspirin remains a cornerstone treatment in the periprocedural and acute phase of PCI in patients without indications for oral anticoagulation.” 

However, he added that the study opens several important points for subsequent discussion.

These include the role of type and dose of P2Y12 inhibitor therapy used; specifically, he questioned whether the 3.75-mg dose of prasugrel was enough.

Dr. Valgimigli also pointed out that this study did not include a purely high bleeding risk population, and he said there was still potential to investigate periprocedure versus postprocedure aspirin administration.

The STOPDAPT-3 trial was funded by Abbott Medical Japan. Dr. Natsuaki reported receiving honoraria from Abbott Medical Japan, Daiichi Sankyo, and Bayer.

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

AMSTERDAM – Dropping aspirin and using low-dose prasugrel (Effient) alone in the initial month of treatment after percutaneous coronary intervention (PCI) failed to lower bleeding risk, compared with dual antiplatelet therapy (DAPT), and there was a signal of possible harm in terms of increased subacute stent thrombosis, in the STOPDAPT-3 trial.

“Therefore, dual antiplatelet therapy with aspirin and a P2Y12 inhibitor should still remain the standard strategy at least for 1 month after PCI,” said the trial’s lead investigator Masahiro Natsuaki, MD, Saga (Japan) University.

The STOPDAPT-3 trial was presented at the recent annual congress of the European Society of Cardiology.

Designated discussant Marco Valgimigli, MD, Cardiocentro Ticino Foundation, Lugano, Switzerland, explained that the current wisdom before this study was that aspirin withdrawal in the postacute phase after PCI (after 1 month of DAPT onwards) is associated with lower bleeding risk without affecting ischemic risk, but this STOPDAPT-3 trial is the first to look at the idea of not giving aspirin at all.

“This study is a well-designed, well-conducted trial, and the results are very clear: there is no benefit of dropping aspirin in this early period with respect to major bleeding, and at the same time there was some signal for possible harm,” Dr. Valgimigli said.

He pointed out that the possible harm was not related to the coprimary cardiovascular composite endpoint, which did fulfill noninferiority, although he acknowledged the “generous” noninferiority margin.

Rather, the possible harm was related to an increase in subacute stent thrombosis, which was three times higher in the nonaspirin group (0.58% vs. 0.17%). 

“While these absolute event rates are extremely low, they are unquestionably higher in the nonaspirin group,” he added.

In his presentation, Dr. Natsuaki explained that very short durations (1-3 months) of DAPT followed by P2Y12 inhibitor monotherapy has been shown to reduce bleeding events without increasing cardiovascular events, compared with longer durations of DAPT after PCI using drug-eluting stents.

However, the incidence of major bleeding events within the 1-month mandatory DAPT period after PCI remains high in clinical practice, particularly in patients with ACS or high bleeding risk.

In single-arm studies, use of prasugrel or ticagrelor (Brilinta) alone following new-generation drug-eluting stent implantation was not associated with any stent thrombosis in selected low-risk patients with or without ACS, and it is thought that removing aspirin from the DAPT regimen might reduce bleeding events early after PCI without compromising the risk of cardiovascular events. However, the efficacy and safety of this strategy has not been proven in randomized trials.
 

STOPDAPT-3 trial

STOPDAPT-3 investigated the efficacy and safety of prasugrel monotherapy compared with 1-month DAPT with aspirin and prasugrel in Japanese patients with ACS or high bleeding risk undergoing PCI with cobalt-chromium everolimus-eluting stents.

The study enrolled 6,002 patients with ACS or high bleeding risk who were randomly assigned to prasugrel monotherapy (3.75 mg/day; the licensed dose in Japan) or to DAPT with aspirin (81-100 mg/day) and prasugrel after a loading dose of prasugrel 20 mg in both groups.

There were two primary endpoints: major bleeding events (defined as BARC type 3 or 5) at 1 month for superiority and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) at 1 month for noninferiority.

The major secondary endpoint was a composite of the coprimary bleeding and cardiovascular endpoints (cardiovascular death, myocardial infarction, definite stent thrombosis, stroke, or major bleeding) at 1 month representing net clinical benefit.

Results showed that, at 1 month, the no-aspirin strategy was not superior to DAPT for the coprimary bleeding endpoint, with major bleeding events occurring in 4.47% of the prasugrel monotherapy group versus 4.71% of those on DAPT (hazard ratio, 0.95; 95% confidence interval, 0.75-1.20).

The prasugrel monotherapy strategy was noninferior to DAPT, although there was a relative 50% margin for the coprimary cardiovascular endpoint. Cardiovascular endpoints occurred in 4.12% of prasugrel monotherapy group versus 3.69% of the DAPT patients (HR, 1.12; 95% CI, 0.87-1.45; P for noninferiority = .01).

The major secondary net clinical benefit endpoint occurred in 7.14% patients in the prasugrel monotherapy group and 7.38% patients in the DAPT group, with no between-group difference, indicating a similar effect on net clinical benefit for both groups.

However, there was an excess of any coronary revascularization (1.15% vs. 0.57%) and definite or probable stent thrombosis (0.71% vs. 0.44%) in the prasugrel monotherapy group compared with the DAPT group, while definite stent thrombosis was not different between the two groups (0.47% vs. 0.37%).

In a subgroup analysis stratified by ACS and non-ACS, the excess risk for cardiovascular events in the no-aspirin group, compared with the DAPT group, was seen in patients with ACS, but not in those without ACS.
 

Future: Focus on dose and timing

In his discussion, Dr. Valgimigli said the implications of this trial for clinical practice were very clear: “Aspirin remains a cornerstone treatment in the periprocedural and acute phase of PCI in patients without indications for oral anticoagulation.” 

However, he added that the study opens several important points for subsequent discussion.

These include the role of type and dose of P2Y12 inhibitor therapy used; specifically, he questioned whether the 3.75-mg dose of prasugrel was enough.

Dr. Valgimigli also pointed out that this study did not include a purely high bleeding risk population, and he said there was still potential to investigate periprocedure versus postprocedure aspirin administration.

The STOPDAPT-3 trial was funded by Abbott Medical Japan. Dr. Natsuaki reported receiving honoraria from Abbott Medical Japan, Daiichi Sankyo, and Bayer.

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

AMSTERDAM – Dropping aspirin and using low-dose prasugrel (Effient) alone in the initial month of treatment after percutaneous coronary intervention (PCI) failed to lower bleeding risk, compared with dual antiplatelet therapy (DAPT), and there was a signal of possible harm in terms of increased subacute stent thrombosis, in the STOPDAPT-3 trial.

“Therefore, dual antiplatelet therapy with aspirin and a P2Y12 inhibitor should still remain the standard strategy at least for 1 month after PCI,” said the trial’s lead investigator Masahiro Natsuaki, MD, Saga (Japan) University.

The STOPDAPT-3 trial was presented at the recent annual congress of the European Society of Cardiology.

Designated discussant Marco Valgimigli, MD, Cardiocentro Ticino Foundation, Lugano, Switzerland, explained that the current wisdom before this study was that aspirin withdrawal in the postacute phase after PCI (after 1 month of DAPT onwards) is associated with lower bleeding risk without affecting ischemic risk, but this STOPDAPT-3 trial is the first to look at the idea of not giving aspirin at all.

“This study is a well-designed, well-conducted trial, and the results are very clear: there is no benefit of dropping aspirin in this early period with respect to major bleeding, and at the same time there was some signal for possible harm,” Dr. Valgimigli said.

He pointed out that the possible harm was not related to the coprimary cardiovascular composite endpoint, which did fulfill noninferiority, although he acknowledged the “generous” noninferiority margin.

Rather, the possible harm was related to an increase in subacute stent thrombosis, which was three times higher in the nonaspirin group (0.58% vs. 0.17%). 

“While these absolute event rates are extremely low, they are unquestionably higher in the nonaspirin group,” he added.

In his presentation, Dr. Natsuaki explained that very short durations (1-3 months) of DAPT followed by P2Y12 inhibitor monotherapy has been shown to reduce bleeding events without increasing cardiovascular events, compared with longer durations of DAPT after PCI using drug-eluting stents.

However, the incidence of major bleeding events within the 1-month mandatory DAPT period after PCI remains high in clinical practice, particularly in patients with ACS or high bleeding risk.

In single-arm studies, use of prasugrel or ticagrelor (Brilinta) alone following new-generation drug-eluting stent implantation was not associated with any stent thrombosis in selected low-risk patients with or without ACS, and it is thought that removing aspirin from the DAPT regimen might reduce bleeding events early after PCI without compromising the risk of cardiovascular events. However, the efficacy and safety of this strategy has not been proven in randomized trials.
 

STOPDAPT-3 trial

STOPDAPT-3 investigated the efficacy and safety of prasugrel monotherapy compared with 1-month DAPT with aspirin and prasugrel in Japanese patients with ACS or high bleeding risk undergoing PCI with cobalt-chromium everolimus-eluting stents.

The study enrolled 6,002 patients with ACS or high bleeding risk who were randomly assigned to prasugrel monotherapy (3.75 mg/day; the licensed dose in Japan) or to DAPT with aspirin (81-100 mg/day) and prasugrel after a loading dose of prasugrel 20 mg in both groups.

There were two primary endpoints: major bleeding events (defined as BARC type 3 or 5) at 1 month for superiority and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) at 1 month for noninferiority.

The major secondary endpoint was a composite of the coprimary bleeding and cardiovascular endpoints (cardiovascular death, myocardial infarction, definite stent thrombosis, stroke, or major bleeding) at 1 month representing net clinical benefit.

Results showed that, at 1 month, the no-aspirin strategy was not superior to DAPT for the coprimary bleeding endpoint, with major bleeding events occurring in 4.47% of the prasugrel monotherapy group versus 4.71% of those on DAPT (hazard ratio, 0.95; 95% confidence interval, 0.75-1.20).

The prasugrel monotherapy strategy was noninferior to DAPT, although there was a relative 50% margin for the coprimary cardiovascular endpoint. Cardiovascular endpoints occurred in 4.12% of prasugrel monotherapy group versus 3.69% of the DAPT patients (HR, 1.12; 95% CI, 0.87-1.45; P for noninferiority = .01).

The major secondary net clinical benefit endpoint occurred in 7.14% patients in the prasugrel monotherapy group and 7.38% patients in the DAPT group, with no between-group difference, indicating a similar effect on net clinical benefit for both groups.

However, there was an excess of any coronary revascularization (1.15% vs. 0.57%) and definite or probable stent thrombosis (0.71% vs. 0.44%) in the prasugrel monotherapy group compared with the DAPT group, while definite stent thrombosis was not different between the two groups (0.47% vs. 0.37%).

In a subgroup analysis stratified by ACS and non-ACS, the excess risk for cardiovascular events in the no-aspirin group, compared with the DAPT group, was seen in patients with ACS, but not in those without ACS.
 

Future: Focus on dose and timing

In his discussion, Dr. Valgimigli said the implications of this trial for clinical practice were very clear: “Aspirin remains a cornerstone treatment in the periprocedural and acute phase of PCI in patients without indications for oral anticoagulation.” 

However, he added that the study opens several important points for subsequent discussion.

These include the role of type and dose of P2Y12 inhibitor therapy used; specifically, he questioned whether the 3.75-mg dose of prasugrel was enough.

Dr. Valgimigli also pointed out that this study did not include a purely high bleeding risk population, and he said there was still potential to investigate periprocedure versus postprocedure aspirin administration.

The STOPDAPT-3 trial was funded by Abbott Medical Japan. Dr. Natsuaki reported receiving honoraria from Abbott Medical Japan, Daiichi Sankyo, and Bayer.

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

Women tested for vaginitis using a nucleic amplification test were significantly more likely to be cotested for Chlamydia trachomatis and Neissaria gonorrhoeae than women who were diagnosed based on other test types, based on data from more than 1.3 million individuals.

Penn State University

Although the standard of care of diagnosing vaginitis is clinical evaluation, many practices do not perform accurate and comprehensive clinical examinations for a variety for reasons, and the Centers for Disease Control and Prevention currently recommends molecular testing, wrote Casey N. Pinto, PhD, of Penn State University, Hershey, and colleagues. The CDC also recommends testing women with vaginitis for Chlamydia trachomatis (CT) and Neissaria gonorrhoeae (NG) given the high rate of coinfections between vaginitis and these sexually transmitted infections, but data on cotesting in clinical practice are limited, they said.

In a study published in Sexually Transmitted Diseases, the researchers reviewed data from a commercial administrative claims database for 1,359,289 women aged 18-50 years who were diagnosed with vaginitis between 2012 and 2017.

The women were categorized into groups based on type of vaginitis diagnosis: nucleic amplification test (NAAT), DNA probe test, traditional lab test, and those diagnosed clinically at an index visit but with no CPT code for further testing.

Overall, nearly half of the women (49.2%) had no CPT code for further vaginitis testing beyond clinical diagnosis. Of those with CPT codes for testing, 50.9% underwent traditional point-of-care testing, wet mount, or culture, 23.5% had a DNA probe, and 20.6% had NAAT testing.

Approximately one-third (34%) of women were cotested for CT/NG. Testing rates varied widely across the type of vaginitis test, from 70.8% of women who received NAAT to 22.8% of women with no CPT code. In multivariate analysis including age, region, and the Charlson Comorbidity Index (CCI), those tested with NAAT were eight times more likely to be cotested for CT/NG than those with no CPT code (odds ratio, 8.77; P < .0001).

Women who received a traditional test or DNA probe test for vaginitis also were more likely to have CT/NG testing than women with no CPT code, but only 1.8-2.5 times as likely.

“Our data suggest that most clinicians are not engaging the standard of care for testing and diagnosing vaginitis, or not engaging in comprehensive care by cotesting for vaginitis and CT/NG when patients may be at risk, resulting in missed opportunities for accurate diagnosis and potential associated coinfections,” the researchers wrote in their discussion. The higher rates for CT/NG testing among women receiving either NAAT or DNA probe vaginitis testing could be attributed to bundled testing, they noted, and the lower rate of CT/NG testing for patients with no CPT code could stem from limited access to microscopy or clinician preference for clinical diagnosis only, they said.

The findings were limited by several factors, including the lack of data on testing and diagnoses prior to the study period and not billed to insurance, and by the inability to account for variables including race, ethnicity, and socioeconomic status, the researchers noted.

However, the results highlight the need for more comprehensive care in vaginitis testing to take advantage of opportunities to identify CT or NG in women diagnosed with vaginitis, they concluded.

The study was supported by Becton, Dickinson and Company. Lead author Dr. Pinto disclosed consulting for Becton, Dickinson and Company, and receiving an honorarium from Roche.

Women tested for vaginitis using a nucleic amplification test were significantly more likely to be cotested for Chlamydia trachomatis and Neissaria gonorrhoeae than women who were diagnosed based on other test types, based on data from more than 1.3 million individuals.

Penn State University

Although the standard of care of diagnosing vaginitis is clinical evaluation, many practices do not perform accurate and comprehensive clinical examinations for a variety for reasons, and the Centers for Disease Control and Prevention currently recommends molecular testing, wrote Casey N. Pinto, PhD, of Penn State University, Hershey, and colleagues. The CDC also recommends testing women with vaginitis for Chlamydia trachomatis (CT) and Neissaria gonorrhoeae (NG) given the high rate of coinfections between vaginitis and these sexually transmitted infections, but data on cotesting in clinical practice are limited, they said.

In a study published in Sexually Transmitted Diseases, the researchers reviewed data from a commercial administrative claims database for 1,359,289 women aged 18-50 years who were diagnosed with vaginitis between 2012 and 2017.

The women were categorized into groups based on type of vaginitis diagnosis: nucleic amplification test (NAAT), DNA probe test, traditional lab test, and those diagnosed clinically at an index visit but with no CPT code for further testing.

Overall, nearly half of the women (49.2%) had no CPT code for further vaginitis testing beyond clinical diagnosis. Of those with CPT codes for testing, 50.9% underwent traditional point-of-care testing, wet mount, or culture, 23.5% had a DNA probe, and 20.6% had NAAT testing.

Approximately one-third (34%) of women were cotested for CT/NG. Testing rates varied widely across the type of vaginitis test, from 70.8% of women who received NAAT to 22.8% of women with no CPT code. In multivariate analysis including age, region, and the Charlson Comorbidity Index (CCI), those tested with NAAT were eight times more likely to be cotested for CT/NG than those with no CPT code (odds ratio, 8.77; P < .0001).

Women who received a traditional test or DNA probe test for vaginitis also were more likely to have CT/NG testing than women with no CPT code, but only 1.8-2.5 times as likely.

“Our data suggest that most clinicians are not engaging the standard of care for testing and diagnosing vaginitis, or not engaging in comprehensive care by cotesting for vaginitis and CT/NG when patients may be at risk, resulting in missed opportunities for accurate diagnosis and potential associated coinfections,” the researchers wrote in their discussion. The higher rates for CT/NG testing among women receiving either NAAT or DNA probe vaginitis testing could be attributed to bundled testing, they noted, and the lower rate of CT/NG testing for patients with no CPT code could stem from limited access to microscopy or clinician preference for clinical diagnosis only, they said.

The findings were limited by several factors, including the lack of data on testing and diagnoses prior to the study period and not billed to insurance, and by the inability to account for variables including race, ethnicity, and socioeconomic status, the researchers noted.

However, the results highlight the need for more comprehensive care in vaginitis testing to take advantage of opportunities to identify CT or NG in women diagnosed with vaginitis, they concluded.

The study was supported by Becton, Dickinson and Company. Lead author Dr. Pinto disclosed consulting for Becton, Dickinson and Company, and receiving an honorarium from Roche.

Women tested for vaginitis using a nucleic amplification test were significantly more likely to be cotested for Chlamydia trachomatis and Neissaria gonorrhoeae than women who were diagnosed based on other test types, based on data from more than 1.3 million individuals.

Penn State University

Although the standard of care of diagnosing vaginitis is clinical evaluation, many practices do not perform accurate and comprehensive clinical examinations for a variety for reasons, and the Centers for Disease Control and Prevention currently recommends molecular testing, wrote Casey N. Pinto, PhD, of Penn State University, Hershey, and colleagues. The CDC also recommends testing women with vaginitis for Chlamydia trachomatis (CT) and Neissaria gonorrhoeae (NG) given the high rate of coinfections between vaginitis and these sexually transmitted infections, but data on cotesting in clinical practice are limited, they said.

In a study published in Sexually Transmitted Diseases, the researchers reviewed data from a commercial administrative claims database for 1,359,289 women aged 18-50 years who were diagnosed with vaginitis between 2012 and 2017.

The women were categorized into groups based on type of vaginitis diagnosis: nucleic amplification test (NAAT), DNA probe test, traditional lab test, and those diagnosed clinically at an index visit but with no CPT code for further testing.

Overall, nearly half of the women (49.2%) had no CPT code for further vaginitis testing beyond clinical diagnosis. Of those with CPT codes for testing, 50.9% underwent traditional point-of-care testing, wet mount, or culture, 23.5% had a DNA probe, and 20.6% had NAAT testing.

Approximately one-third (34%) of women were cotested for CT/NG. Testing rates varied widely across the type of vaginitis test, from 70.8% of women who received NAAT to 22.8% of women with no CPT code. In multivariate analysis including age, region, and the Charlson Comorbidity Index (CCI), those tested with NAAT were eight times more likely to be cotested for CT/NG than those with no CPT code (odds ratio, 8.77; P < .0001).

Women who received a traditional test or DNA probe test for vaginitis also were more likely to have CT/NG testing than women with no CPT code, but only 1.8-2.5 times as likely.

“Our data suggest that most clinicians are not engaging the standard of care for testing and diagnosing vaginitis, or not engaging in comprehensive care by cotesting for vaginitis and CT/NG when patients may be at risk, resulting in missed opportunities for accurate diagnosis and potential associated coinfections,” the researchers wrote in their discussion. The higher rates for CT/NG testing among women receiving either NAAT or DNA probe vaginitis testing could be attributed to bundled testing, they noted, and the lower rate of CT/NG testing for patients with no CPT code could stem from limited access to microscopy or clinician preference for clinical diagnosis only, they said.

The findings were limited by several factors, including the lack of data on testing and diagnoses prior to the study period and not billed to insurance, and by the inability to account for variables including race, ethnicity, and socioeconomic status, the researchers noted.

However, the results highlight the need for more comprehensive care in vaginitis testing to take advantage of opportunities to identify CT or NG in women diagnosed with vaginitis, they concluded.

The study was supported by Becton, Dickinson and Company. Lead author Dr. Pinto disclosed consulting for Becton, Dickinson and Company, and receiving an honorarium from Roche.

There is now an additional option for the prevention of respiratory syncytial virus (RSV), the most common cause of hospitalization among infants and children in the United States. In July, the US Food and Drug Administration (FDA) approved nirsevimab, an RSV preventive monoclonal antibody, for use in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to RSV during their second season.¹ The Advisory Committee on Immunization Practices (ACIP) subsequently made 2 recommendations regarding use of nirsevimab, which I’ll detail in a moment.²

First, a word about RSV. The Centers for Disease Control and Prevention estimates that each year in children younger than 5 years, RSV is responsible for 1.5 million outpatient clinic visits, 520,000 emergency department visits, 58,000 to 80,000 hospitalizations, and 100 to 200 deaths.² The risk for hospitalization from RSV is highest in the second and third months of life and decreases with increasing age.

There are some racial disparities in RSV severity, likely reflecting social drivers of health: ICU admission rates are 1.2 to 1.6 times higher among non-Hispanic Black infants younger than 6 months than among non-Hispanic White infants, and hospitalization rates are up to 5 times higher in American Indian and Alaska Native populations.²

What nirsevimab adds to the toolbox. Until recently, there was only 1 RSV preventive agent available: palivizumab, also a monoclonal antibody. The American Academy of Pediatrics has recommended palivizumab be used only for infants at high risk for RSV infection, due to its high cost and the need for monthly injections for the duration of an RSV season. In addition, the Academy has noted that palivizumab has limited effect on RSV hospitalizations on a population basis and does not appear to affect mortality.³

Nirsevimab has a longer half-life than palivizumab, and only 1 injection is needed for the RSV season. Early studies on nirsevimab demonstrate 79% effectiveness in preventing medical-attended lower respiratory tract infection, 80.6% effectiveness in preventing hospitalization, and 90% effectiveness in preventing ICU admission. The number needed to immunize with nirsevimab to prevent an outpatient visit is estimated to be 17; to prevent an ED visit, 48; and to prevent an inpatient admission, 128. Due to the low RSV death rate, the studies were not able to demonstrate reduced mortality.²

What the ACIP recommends. At a special meeting in July, the ACIP recommended 1 dose of nirsevimab for²:

• all infants younger than 8 months who are born during or entering their first RSV season
• children ages 8 to 19 months who are at increased risk for severe RSV disease and entering their second RSV season.

Those at risk include children with chronic lung disease of prematurity who required medical support any time during the 6-month period before the start of their second RSV season; those with severe immunocompromise; those with cystic fibrosis who have manifestations of severe lung disease or weight-for-length < 10th percentile; and American Indian and Alaska Native children.²

How to administer nirsevimab. The dose of nirsevimab is 50 mg IM for those weighing < 5 kg, 100 mg for those weighing ≥ 5 kg, and 200 mg for high-risk children entering their second RSV season.² Nirsevimab can be co-administered with other recommended vaccines; however, both nirsevimab and palivizumab should not be used in the same child in the same RSV season.

Nirsevimab should be administered in the first week of life for infants born shortly before or during RSV season, and shortly before the season for infants younger than 8 months and those ages 8 to 19 months who are at high risk.⁴ The months of highest RSV transmission in most locations are December through February, but this can vary. Local epidemiology and advice from state and local health departments are the best source of information about when RSV season starts and ends in your area.

On the horizon. Nirsevimab will be included in the Vaccines for Children program and covered by commercial health plans with no cost sharing.⁵ A maternal vaccine to prevent RSV in newborns is likely to be approved by the FDA in the near future.

There is now an additional option for the prevention of respiratory syncytial virus (RSV), the most common cause of hospitalization among infants and children in the United States. In July, the US Food and Drug Administration (FDA) approved nirsevimab, an RSV preventive monoclonal antibody, for use in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to RSV during their second season.¹ The Advisory Committee on Immunization Practices (ACIP) subsequently made 2 recommendations regarding use of nirsevimab, which I’ll detail in a moment.²

First, a word about RSV. The Centers for Disease Control and Prevention estimates that each year in children younger than 5 years, RSV is responsible for 1.5 million outpatient clinic visits, 520,000 emergency department visits, 58,000 to 80,000 hospitalizations, and 100 to 200 deaths.² The risk for hospitalization from RSV is highest in the second and third months of life and decreases with increasing age.

There are some racial disparities in RSV severity, likely reflecting social drivers of health: ICU admission rates are 1.2 to 1.6 times higher among non-Hispanic Black infants younger than 6 months than among non-Hispanic White infants, and hospitalization rates are up to 5 times higher in American Indian and Alaska Native populations.²

What nirsevimab adds to the toolbox. Until recently, there was only 1 RSV preventive agent available: palivizumab, also a monoclonal antibody. The American Academy of Pediatrics has recommended palivizumab be used only for infants at high risk for RSV infection, due to its high cost and the need for monthly injections for the duration of an RSV season. In addition, the Academy has noted that palivizumab has limited effect on RSV hospitalizations on a population basis and does not appear to affect mortality.³

Nirsevimab has a longer half-life than palivizumab, and only 1 injection is needed for the RSV season. Early studies on nirsevimab demonstrate 79% effectiveness in preventing medical-attended lower respiratory tract infection, 80.6% effectiveness in preventing hospitalization, and 90% effectiveness in preventing ICU admission. The number needed to immunize with nirsevimab to prevent an outpatient visit is estimated to be 17; to prevent an ED visit, 48; and to prevent an inpatient admission, 128. Due to the low RSV death rate, the studies were not able to demonstrate reduced mortality.²

What the ACIP recommends. At a special meeting in July, the ACIP recommended 1 dose of nirsevimab for²:

• all infants younger than 8 months who are born during or entering their first RSV season
• children ages 8 to 19 months who are at increased risk for severe RSV disease and entering their second RSV season.

Those at risk include children with chronic lung disease of prematurity who required medical support any time during the 6-month period before the start of their second RSV season; those with severe immunocompromise; those with cystic fibrosis who have manifestations of severe lung disease or weight-for-length < 10th percentile; and American Indian and Alaska Native children.²

How to administer nirsevimab. The dose of nirsevimab is 50 mg IM for those weighing < 5 kg, 100 mg for those weighing ≥ 5 kg, and 200 mg for high-risk children entering their second RSV season.² Nirsevimab can be co-administered with other recommended vaccines; however, both nirsevimab and palivizumab should not be used in the same child in the same RSV season.

Nirsevimab should be administered in the first week of life for infants born shortly before or during RSV season, and shortly before the season for infants younger than 8 months and those ages 8 to 19 months who are at high risk.⁴ The months of highest RSV transmission in most locations are December through February, but this can vary. Local epidemiology and advice from state and local health departments are the best source of information about when RSV season starts and ends in your area.

On the horizon. Nirsevimab will be included in the Vaccines for Children program and covered by commercial health plans with no cost sharing.⁵ A maternal vaccine to prevent RSV in newborns is likely to be approved by the FDA in the near future.

There is now an additional option for the prevention of respiratory syncytial virus (RSV), the most common cause of hospitalization among infants and children in the United States. In July, the US Food and Drug Administration (FDA) approved nirsevimab, an RSV preventive monoclonal antibody, for use in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to RSV during their second season.¹ The Advisory Committee on Immunization Practices (ACIP) subsequently made 2 recommendations regarding use of nirsevimab, which I’ll detail in a moment.²

First, a word about RSV. The Centers for Disease Control and Prevention estimates that each year in children younger than 5 years, RSV is responsible for 1.5 million outpatient clinic visits, 520,000 emergency department visits, 58,000 to 80,000 hospitalizations, and 100 to 200 deaths.² The risk for hospitalization from RSV is highest in the second and third months of life and decreases with increasing age.

There are some racial disparities in RSV severity, likely reflecting social drivers of health: ICU admission rates are 1.2 to 1.6 times higher among non-Hispanic Black infants younger than 6 months than among non-Hispanic White infants, and hospitalization rates are up to 5 times higher in American Indian and Alaska Native populations.²

What nirsevimab adds to the toolbox. Until recently, there was only 1 RSV preventive agent available: palivizumab, also a monoclonal antibody. The American Academy of Pediatrics has recommended palivizumab be used only for infants at high risk for RSV infection, due to its high cost and the need for monthly injections for the duration of an RSV season. In addition, the Academy has noted that palivizumab has limited effect on RSV hospitalizations on a population basis and does not appear to affect mortality.³

Nirsevimab has a longer half-life than palivizumab, and only 1 injection is needed for the RSV season. Early studies on nirsevimab demonstrate 79% effectiveness in preventing medical-attended lower respiratory tract infection, 80.6% effectiveness in preventing hospitalization, and 90% effectiveness in preventing ICU admission. The number needed to immunize with nirsevimab to prevent an outpatient visit is estimated to be 17; to prevent an ED visit, 48; and to prevent an inpatient admission, 128. Due to the low RSV death rate, the studies were not able to demonstrate reduced mortality.²

What the ACIP recommends. At a special meeting in July, the ACIP recommended 1 dose of nirsevimab for²:

• all infants younger than 8 months who are born during or entering their first RSV season
• children ages 8 to 19 months who are at increased risk for severe RSV disease and entering their second RSV season.

Those at risk include children with chronic lung disease of prematurity who required medical support any time during the 6-month period before the start of their second RSV season; those with severe immunocompromise; those with cystic fibrosis who have manifestations of severe lung disease or weight-for-length < 10th percentile; and American Indian and Alaska Native children.²

How to administer nirsevimab. The dose of nirsevimab is 50 mg IM for those weighing < 5 kg, 100 mg for those weighing ≥ 5 kg, and 200 mg for high-risk children entering their second RSV season.² Nirsevimab can be co-administered with other recommended vaccines; however, both nirsevimab and palivizumab should not be used in the same child in the same RSV season.

Nirsevimab should be administered in the first week of life for infants born shortly before or during RSV season, and shortly before the season for infants younger than 8 months and those ages 8 to 19 months who are at high risk.⁴ The months of highest RSV transmission in most locations are December through February, but this can vary. Local epidemiology and advice from state and local health departments are the best source of information about when RSV season starts and ends in your area.

On the horizon. Nirsevimab will be included in the Vaccines for Children program and covered by commercial health plans with no cost sharing.⁵ A maternal vaccine to prevent RSV in newborns is likely to be approved by the FDA in the near future.

The European Society of Cardiology has released new guidelines for cardiomyopathies, their first major comprehensive international guidelines to address diagnosis and treatment of the broad causes of heart muscle dysfunction.

The document was released in conjunction with the annual congress of the European Society of Cardiology and is also available online in the European Heart Journal.

“We have considered cardiomyopathies across the life course from pediatric to adult,” explained Elena Arbelo, MD, PhD, coordinator of the cardiac genetic diseases and sudden arrhythmic death unit, Hospital Clinic de Barcelona. Dr. Arbelo is first author and one of two chairpersons of the ESC task force that brought the guidelines forward.

Not an update, the ESC guidelines are the first to “include all cardiomyopathy subtypes, and the first time that specific recommendations are made for cardiomyopathies other than hypertrophic cardiomyopathy” (HCM), Dr. Arbelo said.
 

Guidelines organize cardiomyopathy phenotypes

Cardiomyopathy can present at any age. It can have multiple complex etiologies, including genetic predisposition, heart muscle injury caused by disease, or a mix of participating factors. The ESC task force employed several strategies in taking a comprehensive approach to the condition, said Juan Kaski, MD, PhD, professor of pediatric inherited cardiovascular medicine at the University College of London.

“From my point of view, the key innovations include a diagnostic workup that starts with a detailed phenotypic description, including the new phenotype of nondilated left ventricular cardiomyopathy, that then triggers a multiparametric, systematic evaluation,” said Dr. Kaski, cochair of the task force.

As explained in the introduction to the guideline and reiterated by both Dr. Arbelo and Dr. Kaski, the guidelines have been organized around the patient pathway, meaning that focus should be placed on recognizing the presenting phenotype as a critical first step in discerning the underlying etiology and its treatments.

“Central to this approach is not only the individual patient but also the family as a whole,” Dr. Arbelo said. “Clinical findings in relatives are essential for understanding what happens to the patient and vice versa.”
 

Genetic testing in children described

The new guidelines include specific recommendations about genetic testing of children. They also emphasize the value of cardiovascular magnetic resonance (CMR) imaging in the “diagnosis, screening, monitoring, and prognostication” for patients of all ages, according to Dr. Kaski.

“CMR is recommended at the initial evaluation for every patient with cardiomyopathy,” Dr. Arbelo said. It should be “considered” during follow-up and for many other applications, including the evaluation of “genotype-positive but phenotype-negative relatives.”

Etiologic prediction models have been incorporated into the guidelines, including genotyping for dilated cardiomyopathies and nondilated left ventricular cardiomyopathy, said both Dr. Arbelo and Dr. Kaski, interviewed separately. They both indicated that the task force did their best to make the guidelines user friendly.

Each of the recommendations in the guidelines is provided with an evidence-based classification. In order, these are class I (recommended), class IIa (should be considered), class IIb (may be considered), and class III (not recommended).
 

Many symptoms are cardiomyopathy related

Dr. Kaski and Dr. Arbelo both emphasized that the guidelines draw attention to the relationship of cardiomyopathy to common cardiovascular conditions, such as heart failure, arrhythmia, and chest pain. Dr. Kaski pointed out that these are the types of problems commonly encountered by general cardiologists and well as primary care physicians.

In 2014, the ESC published guidelines specific to HCM. The new broader guidelines do not overlook this subtype. According to Dr. Kaski, there have been several innovations in HCM since the previous guidelines, such as when to consider cardiac myosin inhibitors for symptomatic left ventricular outflow tract obstruction.

The ESC guidelines place an emphasis on a “coordinated, systematic, and individualized” care pathway based on a multidisciplinary approach, according to Dr. Arbelo. Although the composition of the interdisciplinary team depends on the individual case, the guidelines recognize a key role for general cardiologists in managing the majority of patients. Suggestions of when to refer challenging cases to expert centers are outlined.
 

32 key messages derived from guidelines

The guidelines include almost 90 pages of recommendations. The task force isolated 32 key messages from 13 sections ranging from descriptions of how the patient pathway is defined to what types of physical activity should be considered for different forms of cardiomyopathy. There is also a section devoted to important gaps in evidence and areas in which there is the most need for further studies.

The guidelines end with a comprehensive list of “what to do” and “what not to do” in the diagnosis and care of cardiomyopathy. These include most of the class I recommendations and summarize some important class III cautions.

“Most of the recommendations in the guideline are new,” the authors wrote in the introduction. Although they acknowledged that they did not attempt to provide detailed recommendations for every cardiomyopathy phenotype, they endeavored to cover general evaluation and management issues supported by relevant evidence.

Dr. Arbelo and Dr. Kaski disclosed no relevant financial relationships.

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

The European Society of Cardiology has released new guidelines for cardiomyopathies, their first major comprehensive international guidelines to address diagnosis and treatment of the broad causes of heart muscle dysfunction.

The document was released in conjunction with the annual congress of the European Society of Cardiology and is also available online in the European Heart Journal.

“We have considered cardiomyopathies across the life course from pediatric to adult,” explained Elena Arbelo, MD, PhD, coordinator of the cardiac genetic diseases and sudden arrhythmic death unit, Hospital Clinic de Barcelona. Dr. Arbelo is first author and one of two chairpersons of the ESC task force that brought the guidelines forward.

Not an update, the ESC guidelines are the first to “include all cardiomyopathy subtypes, and the first time that specific recommendations are made for cardiomyopathies other than hypertrophic cardiomyopathy” (HCM), Dr. Arbelo said.
 

Guidelines organize cardiomyopathy phenotypes

Cardiomyopathy can present at any age. It can have multiple complex etiologies, including genetic predisposition, heart muscle injury caused by disease, or a mix of participating factors. The ESC task force employed several strategies in taking a comprehensive approach to the condition, said Juan Kaski, MD, PhD, professor of pediatric inherited cardiovascular medicine at the University College of London.

“From my point of view, the key innovations include a diagnostic workup that starts with a detailed phenotypic description, including the new phenotype of nondilated left ventricular cardiomyopathy, that then triggers a multiparametric, systematic evaluation,” said Dr. Kaski, cochair of the task force.

As explained in the introduction to the guideline and reiterated by both Dr. Arbelo and Dr. Kaski, the guidelines have been organized around the patient pathway, meaning that focus should be placed on recognizing the presenting phenotype as a critical first step in discerning the underlying etiology and its treatments.

“Central to this approach is not only the individual patient but also the family as a whole,” Dr. Arbelo said. “Clinical findings in relatives are essential for understanding what happens to the patient and vice versa.”
 

Genetic testing in children described

The new guidelines include specific recommendations about genetic testing of children. They also emphasize the value of cardiovascular magnetic resonance (CMR) imaging in the “diagnosis, screening, monitoring, and prognostication” for patients of all ages, according to Dr. Kaski.

“CMR is recommended at the initial evaluation for every patient with cardiomyopathy,” Dr. Arbelo said. It should be “considered” during follow-up and for many other applications, including the evaluation of “genotype-positive but phenotype-negative relatives.”

Etiologic prediction models have been incorporated into the guidelines, including genotyping for dilated cardiomyopathies and nondilated left ventricular cardiomyopathy, said both Dr. Arbelo and Dr. Kaski, interviewed separately. They both indicated that the task force did their best to make the guidelines user friendly.

Each of the recommendations in the guidelines is provided with an evidence-based classification. In order, these are class I (recommended), class IIa (should be considered), class IIb (may be considered), and class III (not recommended).
 

Many symptoms are cardiomyopathy related

Dr. Kaski and Dr. Arbelo both emphasized that the guidelines draw attention to the relationship of cardiomyopathy to common cardiovascular conditions, such as heart failure, arrhythmia, and chest pain. Dr. Kaski pointed out that these are the types of problems commonly encountered by general cardiologists and well as primary care physicians.

In 2014, the ESC published guidelines specific to HCM. The new broader guidelines do not overlook this subtype. According to Dr. Kaski, there have been several innovations in HCM since the previous guidelines, such as when to consider cardiac myosin inhibitors for symptomatic left ventricular outflow tract obstruction.

The ESC guidelines place an emphasis on a “coordinated, systematic, and individualized” care pathway based on a multidisciplinary approach, according to Dr. Arbelo. Although the composition of the interdisciplinary team depends on the individual case, the guidelines recognize a key role for general cardiologists in managing the majority of patients. Suggestions of when to refer challenging cases to expert centers are outlined.
 

32 key messages derived from guidelines

The guidelines include almost 90 pages of recommendations. The task force isolated 32 key messages from 13 sections ranging from descriptions of how the patient pathway is defined to what types of physical activity should be considered for different forms of cardiomyopathy. There is also a section devoted to important gaps in evidence and areas in which there is the most need for further studies.

The guidelines end with a comprehensive list of “what to do” and “what not to do” in the diagnosis and care of cardiomyopathy. These include most of the class I recommendations and summarize some important class III cautions.

“Most of the recommendations in the guideline are new,” the authors wrote in the introduction. Although they acknowledged that they did not attempt to provide detailed recommendations for every cardiomyopathy phenotype, they endeavored to cover general evaluation and management issues supported by relevant evidence.

Dr. Arbelo and Dr. Kaski disclosed no relevant financial relationships.

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

The European Society of Cardiology has released new guidelines for cardiomyopathies, their first major comprehensive international guidelines to address diagnosis and treatment of the broad causes of heart muscle dysfunction.

The document was released in conjunction with the annual congress of the European Society of Cardiology and is also available online in the European Heart Journal.

“We have considered cardiomyopathies across the life course from pediatric to adult,” explained Elena Arbelo, MD, PhD, coordinator of the cardiac genetic diseases and sudden arrhythmic death unit, Hospital Clinic de Barcelona. Dr. Arbelo is first author and one of two chairpersons of the ESC task force that brought the guidelines forward.

Not an update, the ESC guidelines are the first to “include all cardiomyopathy subtypes, and the first time that specific recommendations are made for cardiomyopathies other than hypertrophic cardiomyopathy” (HCM), Dr. Arbelo said.
 

Guidelines organize cardiomyopathy phenotypes

Cardiomyopathy can present at any age. It can have multiple complex etiologies, including genetic predisposition, heart muscle injury caused by disease, or a mix of participating factors. The ESC task force employed several strategies in taking a comprehensive approach to the condition, said Juan Kaski, MD, PhD, professor of pediatric inherited cardiovascular medicine at the University College of London.

“From my point of view, the key innovations include a diagnostic workup that starts with a detailed phenotypic description, including the new phenotype of nondilated left ventricular cardiomyopathy, that then triggers a multiparametric, systematic evaluation,” said Dr. Kaski, cochair of the task force.

As explained in the introduction to the guideline and reiterated by both Dr. Arbelo and Dr. Kaski, the guidelines have been organized around the patient pathway, meaning that focus should be placed on recognizing the presenting phenotype as a critical first step in discerning the underlying etiology and its treatments.

“Central to this approach is not only the individual patient but also the family as a whole,” Dr. Arbelo said. “Clinical findings in relatives are essential for understanding what happens to the patient and vice versa.”
 

Genetic testing in children described

The new guidelines include specific recommendations about genetic testing of children. They also emphasize the value of cardiovascular magnetic resonance (CMR) imaging in the “diagnosis, screening, monitoring, and prognostication” for patients of all ages, according to Dr. Kaski.

“CMR is recommended at the initial evaluation for every patient with cardiomyopathy,” Dr. Arbelo said. It should be “considered” during follow-up and for many other applications, including the evaluation of “genotype-positive but phenotype-negative relatives.”

Etiologic prediction models have been incorporated into the guidelines, including genotyping for dilated cardiomyopathies and nondilated left ventricular cardiomyopathy, said both Dr. Arbelo and Dr. Kaski, interviewed separately. They both indicated that the task force did their best to make the guidelines user friendly.

Each of the recommendations in the guidelines is provided with an evidence-based classification. In order, these are class I (recommended), class IIa (should be considered), class IIb (may be considered), and class III (not recommended).
 

Many symptoms are cardiomyopathy related

Dr. Kaski and Dr. Arbelo both emphasized that the guidelines draw attention to the relationship of cardiomyopathy to common cardiovascular conditions, such as heart failure, arrhythmia, and chest pain. Dr. Kaski pointed out that these are the types of problems commonly encountered by general cardiologists and well as primary care physicians.

In 2014, the ESC published guidelines specific to HCM. The new broader guidelines do not overlook this subtype. According to Dr. Kaski, there have been several innovations in HCM since the previous guidelines, such as when to consider cardiac myosin inhibitors for symptomatic left ventricular outflow tract obstruction.

The ESC guidelines place an emphasis on a “coordinated, systematic, and individualized” care pathway based on a multidisciplinary approach, according to Dr. Arbelo. Although the composition of the interdisciplinary team depends on the individual case, the guidelines recognize a key role for general cardiologists in managing the majority of patients. Suggestions of when to refer challenging cases to expert centers are outlined.
 

32 key messages derived from guidelines

The guidelines include almost 90 pages of recommendations. The task force isolated 32 key messages from 13 sections ranging from descriptions of how the patient pathway is defined to what types of physical activity should be considered for different forms of cardiomyopathy. There is also a section devoted to important gaps in evidence and areas in which there is the most need for further studies.

The guidelines end with a comprehensive list of “what to do” and “what not to do” in the diagnosis and care of cardiomyopathy. These include most of the class I recommendations and summarize some important class III cautions.

“Most of the recommendations in the guideline are new,” the authors wrote in the introduction. Although they acknowledged that they did not attempt to provide detailed recommendations for every cardiomyopathy phenotype, they endeavored to cover general evaluation and management issues supported by relevant evidence.

Dr. Arbelo and Dr. Kaski disclosed no relevant financial relationships.

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

TOPLINE:

Nearly 600 million people worldwide (7.6% of the world’s population) have osteoarthritis, and numbers are expected to rise starkly by 2050, especially knee/hip disease.

METHODOLOGY:

• Researchers estimated the prevalence of osteoarthritis in 204 countries and territories from 1990 to 2020 and projected prevalence levels for the year 2050.
• Population-based surveys offered data from 26 countries for knee osteoarthritis, 23 countries for hip osteoarthritis, and 42 countries for hand osteoarthritis. Researchers used U.S. insurance claims to estimate prevalence for other osteoarthritis types.
• Similar analyses were conducted in 2010 and 2017.

TAKEAWAY:

• Osteoarthritis cases worldwide have grown by an estimated 132.2% since 1990. Population growth and aging were identified as major contributing factors.
• In 2020, an estimated 595 million people had osteoarthritis. From 2020 to 2050, cases of osteoarthritis in the knee are expected to grow by 74.9%, in the hand by 48.6%, in the hip by 78.6%, and in other locations by 95.1%.  
• Years lived with disability (age-standardized rate) grew from an estimated 233 per 100,000 in 1990 to 255 per 100,000 in 2020, an increase of 9.5%.
• High body mass index contributed to 20.4% of cases.

IN PRACTICE:

In “a major challenge to health systems,” osteoarthritis may affect nearly 1 billion people in 2050.

SOURCE:

The Global Burden of Disease 2021 Osteoarthritis Collaborators, led by Jaimie D. Steinmetz, PhD, MSc, of the Institute for Health Metrics and Evaluation, Seattle, conducted the study, which was published in The Lancet Rheumatology.

LIMITATIONS:

Limited data, heavy reliance on U.S. insurance data, and other factors may have skewed the results.

DISCLOSURES:

The study was supported by the Bill & Melinda Gates Foundation, the Institute of Bone and Joint Research, and the Global Alliance for Musculoskeletal Health. Multiple authors reported numerous disclosures.

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

TOPLINE:

Nearly 600 million people worldwide (7.6% of the world’s population) have osteoarthritis, and numbers are expected to rise starkly by 2050, especially knee/hip disease.

METHODOLOGY:

• Researchers estimated the prevalence of osteoarthritis in 204 countries and territories from 1990 to 2020 and projected prevalence levels for the year 2050.
• Population-based surveys offered data from 26 countries for knee osteoarthritis, 23 countries for hip osteoarthritis, and 42 countries for hand osteoarthritis. Researchers used U.S. insurance claims to estimate prevalence for other osteoarthritis types.
• Similar analyses were conducted in 2010 and 2017.

TAKEAWAY:

• Osteoarthritis cases worldwide have grown by an estimated 132.2% since 1990. Population growth and aging were identified as major contributing factors.
• In 2020, an estimated 595 million people had osteoarthritis. From 2020 to 2050, cases of osteoarthritis in the knee are expected to grow by 74.9%, in the hand by 48.6%, in the hip by 78.6%, and in other locations by 95.1%.  
• Years lived with disability (age-standardized rate) grew from an estimated 233 per 100,000 in 1990 to 255 per 100,000 in 2020, an increase of 9.5%.
• High body mass index contributed to 20.4% of cases.

IN PRACTICE:

In “a major challenge to health systems,” osteoarthritis may affect nearly 1 billion people in 2050.

SOURCE:

The Global Burden of Disease 2021 Osteoarthritis Collaborators, led by Jaimie D. Steinmetz, PhD, MSc, of the Institute for Health Metrics and Evaluation, Seattle, conducted the study, which was published in The Lancet Rheumatology.

LIMITATIONS:

Limited data, heavy reliance on U.S. insurance data, and other factors may have skewed the results.

DISCLOSURES:

The study was supported by the Bill & Melinda Gates Foundation, the Institute of Bone and Joint Research, and the Global Alliance for Musculoskeletal Health. Multiple authors reported numerous disclosures.

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

TOPLINE:

Nearly 600 million people worldwide (7.6% of the world’s population) have osteoarthritis, and numbers are expected to rise starkly by 2050, especially knee/hip disease.

METHODOLOGY:

• Researchers estimated the prevalence of osteoarthritis in 204 countries and territories from 1990 to 2020 and projected prevalence levels for the year 2050.
• Population-based surveys offered data from 26 countries for knee osteoarthritis, 23 countries for hip osteoarthritis, and 42 countries for hand osteoarthritis. Researchers used U.S. insurance claims to estimate prevalence for other osteoarthritis types.
• Similar analyses were conducted in 2010 and 2017.

TAKEAWAY:

• Osteoarthritis cases worldwide have grown by an estimated 132.2% since 1990. Population growth and aging were identified as major contributing factors.
• In 2020, an estimated 595 million people had osteoarthritis. From 2020 to 2050, cases of osteoarthritis in the knee are expected to grow by 74.9%, in the hand by 48.6%, in the hip by 78.6%, and in other locations by 95.1%.  
• Years lived with disability (age-standardized rate) grew from an estimated 233 per 100,000 in 1990 to 255 per 100,000 in 2020, an increase of 9.5%.
• High body mass index contributed to 20.4% of cases.

IN PRACTICE:

In “a major challenge to health systems,” osteoarthritis may affect nearly 1 billion people in 2050.

SOURCE:

The Global Burden of Disease 2021 Osteoarthritis Collaborators, led by Jaimie D. Steinmetz, PhD, MSc, of the Institute for Health Metrics and Evaluation, Seattle, conducted the study, which was published in The Lancet Rheumatology.

LIMITATIONS:

Limited data, heavy reliance on U.S. insurance data, and other factors may have skewed the results.

DISCLOSURES:

The study was supported by the Bill & Melinda Gates Foundation, the Institute of Bone and Joint Research, and the Global Alliance for Musculoskeletal Health. Multiple authors reported numerous disclosures.

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

PURPOSE

To improve germline genetic testing among Veterans with high risk, very high risk and metastatic prostate cancer.

BACKGROUND

During our Commission on Cancer survey in 2021, it was noted that the Detroit VA’s referrals for germline genetic testing and counseling were extremely low. In 2020, only 1 Veteran was referred for prostate germline genetic testing and counseling and only 8 Veterans were referred in 2021. It was felt that the need to refer Veterans outside of the Detroit VA may have contributed to these low numbers. Our Cancer Committee chose prostate cancer as a disease to focus on. We chose a timeline of one year to implement our process.

METHODS

We made testing and counseling locally accessible to Veterans and encouraged medical oncology providers to make it part of the care of Veterans with high risk, very high risk and metastatic prostate cancer. We sought the assistance of the VA’s National Precision Oncology Program and were able to secure financial and logistical support to perform germline molecular prostate panel testing at the Detroit VA. We were also able to identify a cancer genetic specialist at the Ann Arbor VA that would perform genetic counseling among this group of patients based on their test results. Our medical oncology providers identified Veterans meeting the criteria for testing. Education regarding germline testing, its benefits and implications were conducted with Veterans, and performed after obtaining their informed consent in collaboration with our pathology department. The specimen is then sent to a VA central laboratory for processing. Detroit VA providers are alerted by the local laboratory once results are available. Veterans are then referred to the genetic counseling specialist based on the results. Some of these counseling visits are done virtually for the Veteran’s convenience.

DATA ANALYSIS

A retrospective chart analysis was used to collect the data.

RESULTS

After the implementation of our initiative, 97 Veterans with high risk, very high risk or metastatic prostate cancer were educated on the benefits of germline genetic testing, 87 of whom agreed to be tested. As of 4/2/23, 48 tests have already been performed. Pathogenic variants were recorded on 2 Veterans so far. One was for BRCA2 and KDM6A, and the other was for ATM. Data collection and recording is on-going.

IMPLICATIONS

Improving accessibility and incorporating genetic testing and counseling in cancer care can improve their utilization.

PURPOSE

To improve germline genetic testing among Veterans with high risk, very high risk and metastatic prostate cancer.

BACKGROUND

During our Commission on Cancer survey in 2021, it was noted that the Detroit VA’s referrals for germline genetic testing and counseling were extremely low. In 2020, only 1 Veteran was referred for prostate germline genetic testing and counseling and only 8 Veterans were referred in 2021. It was felt that the need to refer Veterans outside of the Detroit VA may have contributed to these low numbers. Our Cancer Committee chose prostate cancer as a disease to focus on. We chose a timeline of one year to implement our process.

METHODS

We made testing and counseling locally accessible to Veterans and encouraged medical oncology providers to make it part of the care of Veterans with high risk, very high risk and metastatic prostate cancer. We sought the assistance of the VA’s National Precision Oncology Program and were able to secure financial and logistical support to perform germline molecular prostate panel testing at the Detroit VA. We were also able to identify a cancer genetic specialist at the Ann Arbor VA that would perform genetic counseling among this group of patients based on their test results. Our medical oncology providers identified Veterans meeting the criteria for testing. Education regarding germline testing, its benefits and implications were conducted with Veterans, and performed after obtaining their informed consent in collaboration with our pathology department. The specimen is then sent to a VA central laboratory for processing. Detroit VA providers are alerted by the local laboratory once results are available. Veterans are then referred to the genetic counseling specialist based on the results. Some of these counseling visits are done virtually for the Veteran’s convenience.

DATA ANALYSIS

A retrospective chart analysis was used to collect the data.

RESULTS

After the implementation of our initiative, 97 Veterans with high risk, very high risk or metastatic prostate cancer were educated on the benefits of germline genetic testing, 87 of whom agreed to be tested. As of 4/2/23, 48 tests have already been performed. Pathogenic variants were recorded on 2 Veterans so far. One was for BRCA2 and KDM6A, and the other was for ATM. Data collection and recording is on-going.

IMPLICATIONS

Improving accessibility and incorporating genetic testing and counseling in cancer care can improve their utilization.

PURPOSE

To improve germline genetic testing among Veterans with high risk, very high risk and metastatic prostate cancer.

BACKGROUND

During our Commission on Cancer survey in 2021, it was noted that the Detroit VA’s referrals for germline genetic testing and counseling were extremely low. In 2020, only 1 Veteran was referred for prostate germline genetic testing and counseling and only 8 Veterans were referred in 2021. It was felt that the need to refer Veterans outside of the Detroit VA may have contributed to these low numbers. Our Cancer Committee chose prostate cancer as a disease to focus on. We chose a timeline of one year to implement our process.

METHODS

We made testing and counseling locally accessible to Veterans and encouraged medical oncology providers to make it part of the care of Veterans with high risk, very high risk and metastatic prostate cancer. We sought the assistance of the VA’s National Precision Oncology Program and were able to secure financial and logistical support to perform germline molecular prostate panel testing at the Detroit VA. We were also able to identify a cancer genetic specialist at the Ann Arbor VA that would perform genetic counseling among this group of patients based on their test results. Our medical oncology providers identified Veterans meeting the criteria for testing. Education regarding germline testing, its benefits and implications were conducted with Veterans, and performed after obtaining their informed consent in collaboration with our pathology department. The specimen is then sent to a VA central laboratory for processing. Detroit VA providers are alerted by the local laboratory once results are available. Veterans are then referred to the genetic counseling specialist based on the results. Some of these counseling visits are done virtually for the Veteran’s convenience.

DATA ANALYSIS

A retrospective chart analysis was used to collect the data.

RESULTS

After the implementation of our initiative, 97 Veterans with high risk, very high risk or metastatic prostate cancer were educated on the benefits of germline genetic testing, 87 of whom agreed to be tested. As of 4/2/23, 48 tests have already been performed. Pathogenic variants were recorded on 2 Veterans so far. One was for BRCA2 and KDM6A, and the other was for ATM. Data collection and recording is on-going.

IMPLICATIONS

Improving accessibility and incorporating genetic testing and counseling in cancer care can improve their utilization.

Minimizing atrial pacing does not alter the risk of atrial fibrillation (AF) associated with sinus node dysfunction (SND), suggest results of a trial that randomly assigned patients with SND who had received their first pacemaker implant to one of two pacing programs.

Over 2 years of follow-up with remote monitoring, there was no difference in the primary endpoint of time to first device-detected episode of AF lasting more than 6 minutes, reported Max Brix Kronborg, MD, PhD, department of cardiology, Aarhus University Hospital, Denmark.

The study, DANPACE II, excluded patients with permanent or persistent AF or persistent bradycardia prior to or at the time of enrollment.

The findings were presented at annual congress of the European Society of Cardiology and were published online simultaneously in the European Heart Journal.

The 539 participants in the trial were randomly assigned in a 1:1 ratio to a pacing program of 60 beats/minute with rate-adaptive pacing (DDR-60) or 40 beats/minute without rate-adaptive pacing (DDD-40). All patients were equipped with remote monitoring and were followed for 2 years. Tracings were adjudicated for atrial high-rate episodes by experienced device specialists, Dr. Kronborg said.
 

No difference seen in primary outcome

When graphed, curves for the primary outcome in the two groups were essentially superimposable. For the secondary outcomes of AF lasting more than 6 hours and AF lasting more than 24 hours, there was a modest but progressive separation in the lines favoring the DDR-60 group for both. However, the P value did not approach significance in the first of these endpoints (P = .35) and remained only a trend (P = .08) in the second.

There were no substantial differences in results when patients were stratified by age (> 73 years vs. younger), gender (women represented 50% of patients), PR interval (> 150 milliseconds vs. less), or history of AF prior to study entry; the latter group represented approximately 40% of the trial participants.

There was a between-group difference in the primary composite safety endpoint of syncope and presyncope. By 2 years, 13% of those in the DDR-60 group had experienced one of these safety events, vs. 22% (P = .01) of the DDD-40 group.

The study was not designed to determine a cause for these episodes, but Dr. Kronborg reported that bradycardia was suspected in the majority of cases.
 

Crossovers more common on minimal pacing

Crossovers were permitted, and 26% of patients did so at some point in the trial. Of these, about one-third were switched to the opposite arm in response to syncope. Almost all of the others crossed over because of chronotropic incompetence. The greater crossover rate in the DDD-40 group (23% vs. 3%; P < .001) was highly significant.

Quality of life was measured with the SF36 tool, and physical function was evaluated with the 6-minute walk distance test (6MWD). Results on these measures did not differ significantly between groups. For 6MWD, the mean gain from baseline was 8 m in both groups.

The results of this study are important because they challenge what has been a widely held perception among electrophysiologists, according to Cecilia Linde, MD, PhD, a professor of cardiology at the Karolinska Institute, Stockholm.

“I think many of us involved in pacing thought for many years that minimizing pacing would be beneficial, and this clearly shows it is not,” said Dr. Linde, who was the moderator of the scientific session in which these results were presented.
 

Results appear definitive

The ESC-invited discussant, Jose L. Merino, MD, PhD, director of arrhythmia and electrophysiology research, La Paz University Hospital, Madrid, concurred. He said these results are convincing.

On the basis of these findings, which not only failed to show a benefit but showed in the experimental arm a higher incidence of syncope and chronotropic incompetence, Dr. Merino concluded, “Programming intended to minimize atrial pacing should not be used as routine in unselected patients with SND.”

A trend for protection from DDR-60 over DDD-40 from the longest episodes of AF caught Dr. Merino’s attention, leading him to question whether the optimal rate of pacing might be even higher than 60 beats/minute in SND, but he said that is a separate issue. DANPACE was not powered to examine the effect in long duration episodes.

Ultimately, while Dr. Merino characterized the increased risk of syncope with minimized pacing as “an important finding” in regard to dissuading clinicians to pursue this strategy, he said that the underlying question of the DANPACE trial remains unanswered.

Pacing remains “a treatment of choice” in SND, but further investigation is needed “about the optimal pacing rate to minimize AF and syncope” in this population, he said.

Dr. Kronborg reports a financial relationship with Abbott. Dr. Linde reports financial relationships with Cardio 3, Medtronic, St. Jude, and Vifor. Dr. Merino reports financial relationships with Abbott, Medtronic, and Microport.

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

Minimizing atrial pacing does not alter the risk of atrial fibrillation (AF) associated with sinus node dysfunction (SND), suggest results of a trial that randomly assigned patients with SND who had received their first pacemaker implant to one of two pacing programs.

Over 2 years of follow-up with remote monitoring, there was no difference in the primary endpoint of time to first device-detected episode of AF lasting more than 6 minutes, reported Max Brix Kronborg, MD, PhD, department of cardiology, Aarhus University Hospital, Denmark.

The study, DANPACE II, excluded patients with permanent or persistent AF or persistent bradycardia prior to or at the time of enrollment.

The findings were presented at annual congress of the European Society of Cardiology and were published online simultaneously in the European Heart Journal.

The 539 participants in the trial were randomly assigned in a 1:1 ratio to a pacing program of 60 beats/minute with rate-adaptive pacing (DDR-60) or 40 beats/minute without rate-adaptive pacing (DDD-40). All patients were equipped with remote monitoring and were followed for 2 years. Tracings were adjudicated for atrial high-rate episodes by experienced device specialists, Dr. Kronborg said.
 

No difference seen in primary outcome

When graphed, curves for the primary outcome in the two groups were essentially superimposable. For the secondary outcomes of AF lasting more than 6 hours and AF lasting more than 24 hours, there was a modest but progressive separation in the lines favoring the DDR-60 group for both. However, the P value did not approach significance in the first of these endpoints (P = .35) and remained only a trend (P = .08) in the second.

There were no substantial differences in results when patients were stratified by age (> 73 years vs. younger), gender (women represented 50% of patients), PR interval (> 150 milliseconds vs. less), or history of AF prior to study entry; the latter group represented approximately 40% of the trial participants.

There was a between-group difference in the primary composite safety endpoint of syncope and presyncope. By 2 years, 13% of those in the DDR-60 group had experienced one of these safety events, vs. 22% (P = .01) of the DDD-40 group.

The study was not designed to determine a cause for these episodes, but Dr. Kronborg reported that bradycardia was suspected in the majority of cases.
 

Crossovers more common on minimal pacing

Crossovers were permitted, and 26% of patients did so at some point in the trial. Of these, about one-third were switched to the opposite arm in response to syncope. Almost all of the others crossed over because of chronotropic incompetence. The greater crossover rate in the DDD-40 group (23% vs. 3%; P < .001) was highly significant.

Quality of life was measured with the SF36 tool, and physical function was evaluated with the 6-minute walk distance test (6MWD). Results on these measures did not differ significantly between groups. For 6MWD, the mean gain from baseline was 8 m in both groups.

The results of this study are important because they challenge what has been a widely held perception among electrophysiologists, according to Cecilia Linde, MD, PhD, a professor of cardiology at the Karolinska Institute, Stockholm.

“I think many of us involved in pacing thought for many years that minimizing pacing would be beneficial, and this clearly shows it is not,” said Dr. Linde, who was the moderator of the scientific session in which these results were presented.
 

Results appear definitive

The ESC-invited discussant, Jose L. Merino, MD, PhD, director of arrhythmia and electrophysiology research, La Paz University Hospital, Madrid, concurred. He said these results are convincing.

On the basis of these findings, which not only failed to show a benefit but showed in the experimental arm a higher incidence of syncope and chronotropic incompetence, Dr. Merino concluded, “Programming intended to minimize atrial pacing should not be used as routine in unselected patients with SND.”

A trend for protection from DDR-60 over DDD-40 from the longest episodes of AF caught Dr. Merino’s attention, leading him to question whether the optimal rate of pacing might be even higher than 60 beats/minute in SND, but he said that is a separate issue. DANPACE was not powered to examine the effect in long duration episodes.

Ultimately, while Dr. Merino characterized the increased risk of syncope with minimized pacing as “an important finding” in regard to dissuading clinicians to pursue this strategy, he said that the underlying question of the DANPACE trial remains unanswered.

Pacing remains “a treatment of choice” in SND, but further investigation is needed “about the optimal pacing rate to minimize AF and syncope” in this population, he said.

Dr. Kronborg reports a financial relationship with Abbott. Dr. Linde reports financial relationships with Cardio 3, Medtronic, St. Jude, and Vifor. Dr. Merino reports financial relationships with Abbott, Medtronic, and Microport.

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

Minimizing atrial pacing does not alter the risk of atrial fibrillation (AF) associated with sinus node dysfunction (SND), suggest results of a trial that randomly assigned patients with SND who had received their first pacemaker implant to one of two pacing programs.

Over 2 years of follow-up with remote monitoring, there was no difference in the primary endpoint of time to first device-detected episode of AF lasting more than 6 minutes, reported Max Brix Kronborg, MD, PhD, department of cardiology, Aarhus University Hospital, Denmark.

The study, DANPACE II, excluded patients with permanent or persistent AF or persistent bradycardia prior to or at the time of enrollment.

The findings were presented at annual congress of the European Society of Cardiology and were published online simultaneously in the European Heart Journal.

The 539 participants in the trial were randomly assigned in a 1:1 ratio to a pacing program of 60 beats/minute with rate-adaptive pacing (DDR-60) or 40 beats/minute without rate-adaptive pacing (DDD-40). All patients were equipped with remote monitoring and were followed for 2 years. Tracings were adjudicated for atrial high-rate episodes by experienced device specialists, Dr. Kronborg said.
 

No difference seen in primary outcome

When graphed, curves for the primary outcome in the two groups were essentially superimposable. For the secondary outcomes of AF lasting more than 6 hours and AF lasting more than 24 hours, there was a modest but progressive separation in the lines favoring the DDR-60 group for both. However, the P value did not approach significance in the first of these endpoints (P = .35) and remained only a trend (P = .08) in the second.

There were no substantial differences in results when patients were stratified by age (> 73 years vs. younger), gender (women represented 50% of patients), PR interval (> 150 milliseconds vs. less), or history of AF prior to study entry; the latter group represented approximately 40% of the trial participants.

There was a between-group difference in the primary composite safety endpoint of syncope and presyncope. By 2 years, 13% of those in the DDR-60 group had experienced one of these safety events, vs. 22% (P = .01) of the DDD-40 group.

The study was not designed to determine a cause for these episodes, but Dr. Kronborg reported that bradycardia was suspected in the majority of cases.
 

Crossovers more common on minimal pacing

Crossovers were permitted, and 26% of patients did so at some point in the trial. Of these, about one-third were switched to the opposite arm in response to syncope. Almost all of the others crossed over because of chronotropic incompetence. The greater crossover rate in the DDD-40 group (23% vs. 3%; P < .001) was highly significant.

Quality of life was measured with the SF36 tool, and physical function was evaluated with the 6-minute walk distance test (6MWD). Results on these measures did not differ significantly between groups. For 6MWD, the mean gain from baseline was 8 m in both groups.

The results of this study are important because they challenge what has been a widely held perception among electrophysiologists, according to Cecilia Linde, MD, PhD, a professor of cardiology at the Karolinska Institute, Stockholm.

“I think many of us involved in pacing thought for many years that minimizing pacing would be beneficial, and this clearly shows it is not,” said Dr. Linde, who was the moderator of the scientific session in which these results were presented.
 

Results appear definitive

The ESC-invited discussant, Jose L. Merino, MD, PhD, director of arrhythmia and electrophysiology research, La Paz University Hospital, Madrid, concurred. He said these results are convincing.

On the basis of these findings, which not only failed to show a benefit but showed in the experimental arm a higher incidence of syncope and chronotropic incompetence, Dr. Merino concluded, “Programming intended to minimize atrial pacing should not be used as routine in unselected patients with SND.”

A trend for protection from DDR-60 over DDD-40 from the longest episodes of AF caught Dr. Merino’s attention, leading him to question whether the optimal rate of pacing might be even higher than 60 beats/minute in SND, but he said that is a separate issue. DANPACE was not powered to examine the effect in long duration episodes.

Ultimately, while Dr. Merino characterized the increased risk of syncope with minimized pacing as “an important finding” in regard to dissuading clinicians to pursue this strategy, he said that the underlying question of the DANPACE trial remains unanswered.

Pacing remains “a treatment of choice” in SND, but further investigation is needed “about the optimal pacing rate to minimize AF and syncope” in this population, he said.

Dr. Kronborg reports a financial relationship with Abbott. Dr. Linde reports financial relationships with Cardio 3, Medtronic, St. Jude, and Vifor. Dr. Merino reports financial relationships with Abbott, Medtronic, and Microport.

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

New research provides strong evidence of an association between abdominal fat and reduced brain volumes, particularly those involved with cognitive function.

In a large study of healthy middle-aged adults, greater visceral and subcutaneous abdominal fat on abdominal MRI predicted brain atrophy on imaging, especially in women.

“The study shows that excess fat is bad for the brain and worse in women, including in Alzheimer’s disease risk regions,” lead author Cyrus Raji, MD, PhD, with the Mallinckrodt Institute of Radiology, Washington University, St. Louis, Mo., said in an interview.

The study was published online in the journal Aging and Disease
 

Modifiable risk factor

Multiple studies have suggested a connection between body fat accumulation and increased dementia risk. But few have examined the relationship between types of fat (visceral and subcutaneous) and brain volume.

For the new study, 10,000 healthy adults aged 20-80 years (mean age, 52.9 years; 53% men) underwent a short whole-body MRI protocol. Regression analyses of abdominal fat types and normalized brain volumes were evaluated, controlling for age and sex.

The research team found that higher amounts of both visceral and subcutaneous abdominal fat predicted lower total gray and white matter volume, as well as lower volume in the hippocampus, frontal cortex, and temporal, parietal, and occipital lobes.

“The findings are quite dramatic,” Dr. Raji told this news organization. “Overall, we found that both subcutaneous and visceral fat has similar levels of negative relationships with brain volumes.”

Women had a higher burden of brain atrophy with increased visceral fat than men. However, it’s difficult to place the sex differences in context because of the lack of prior work specifically investigating visceral fat, brain volume loss, and sex differences, the researchers caution.

They also note that while statistically significant relationships were observed between visceral fat levels and gray matter volume changes, their effect sizes were generally small. 

“Thus, the statistical significance of this work is influenced by the large sample size and less so by large effect size in any given set of regions,” the investigators write.

Other limitations include the cross-sectional nature of the study, which precludes conclusions about causality. The analysis also did not account for other lifestyle factors such as physical activity, diet, and genetic variables.

The researchers call for further investigation “to better elucidate underlying mechanisms and discover possible interventions targeting abdominal fat reduction as a strategy to maintain brain health.”
 

‘Helpful addition to the literature’

In a comment, Claire Sexton, DPhil, Alzheimer’s Association senior director of scientific programs and outreach, noted that “previous studies have linked obesity with cognitive decline and increased risk of dementia. Rather than using BMI as a proxy for body fat, the current study examined visceral and subcutaneous fat directly using imaging techniques.”

Dr. Sexton, who was not associated with this study, said the finding that increased body fat was associated with reduced brain volumes suggests “a possible mechanism to explain the previously reported associations between obesity and cognition.”

“Though some degree of atrophy and brain shrinkage is common with old age, awareness of this association is important because reduced brain volume may be associated with problems with thinking, memory, and performing everyday tasks, and because rates of obesity continue to rise in the United States, along with obesity-related conditions including heart disease, stroke, type 2 diabetes and certain types of cancer,” she added.

“While a helpful addition to the literature, the study does have important limitations. As an observational study, it cannot establish whether higher levels of body fat directly causes reduced brain volumes,” Dr. Sexton cautioned.

In addition, the study did not take into account important related factors like physical activity and diet, which may influence any relationship between body fat and brain volumes, she noted. “Overall, it is not just one factor that is important to consider when considering risk for cognitive decline and dementia, but multiple factors.

“Obesity and the location of body fat must be considered in combination with one’s total lived experience and habits, including physical activity, education, head injury, sleep, mental health, and the health of your heart/cardiovascular system and other key bodily systems,” Dr. Sexton said.

The Alzheimer’s Association is leading a 2-year clinical trial known as U.S. POINTER to see whether combining physical activity, healthy nutrition, social and intellectual challenges, and improved self-management of medical conditions can protect cognitive function in older adults who are at increased risk for cognitive decline.

This work was supported in part by Providence St. Joseph Health in Seattle; Saint John’s Health Center Foundation; Pacific Neuroscience Institute and Foundation; Will and Cary Singleton; and the McLoughlin family. Dr. Raji is a consultant for Brainreader, Apollo Health, Voxelwise, Neurevolution, Pacific Neuroscience Institute Foundation, and Icometrix. Dr. Sexton reports no relevant financial relationships.

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

New research provides strong evidence of an association between abdominal fat and reduced brain volumes, particularly those involved with cognitive function.

In a large study of healthy middle-aged adults, greater visceral and subcutaneous abdominal fat on abdominal MRI predicted brain atrophy on imaging, especially in women.

“The study shows that excess fat is bad for the brain and worse in women, including in Alzheimer’s disease risk regions,” lead author Cyrus Raji, MD, PhD, with the Mallinckrodt Institute of Radiology, Washington University, St. Louis, Mo., said in an interview.

The study was published online in the journal Aging and Disease
 

Modifiable risk factor

Multiple studies have suggested a connection between body fat accumulation and increased dementia risk. But few have examined the relationship between types of fat (visceral and subcutaneous) and brain volume.

For the new study, 10,000 healthy adults aged 20-80 years (mean age, 52.9 years; 53% men) underwent a short whole-body MRI protocol. Regression analyses of abdominal fat types and normalized brain volumes were evaluated, controlling for age and sex.

The research team found that higher amounts of both visceral and subcutaneous abdominal fat predicted lower total gray and white matter volume, as well as lower volume in the hippocampus, frontal cortex, and temporal, parietal, and occipital lobes.

“The findings are quite dramatic,” Dr. Raji told this news organization. “Overall, we found that both subcutaneous and visceral fat has similar levels of negative relationships with brain volumes.”

Women had a higher burden of brain atrophy with increased visceral fat than men. However, it’s difficult to place the sex differences in context because of the lack of prior work specifically investigating visceral fat, brain volume loss, and sex differences, the researchers caution.

They also note that while statistically significant relationships were observed between visceral fat levels and gray matter volume changes, their effect sizes were generally small. 

“Thus, the statistical significance of this work is influenced by the large sample size and less so by large effect size in any given set of regions,” the investigators write.

Other limitations include the cross-sectional nature of the study, which precludes conclusions about causality. The analysis also did not account for other lifestyle factors such as physical activity, diet, and genetic variables.

The researchers call for further investigation “to better elucidate underlying mechanisms and discover possible interventions targeting abdominal fat reduction as a strategy to maintain brain health.”
 

‘Helpful addition to the literature’

In a comment, Claire Sexton, DPhil, Alzheimer’s Association senior director of scientific programs and outreach, noted that “previous studies have linked obesity with cognitive decline and increased risk of dementia. Rather than using BMI as a proxy for body fat, the current study examined visceral and subcutaneous fat directly using imaging techniques.”

Dr. Sexton, who was not associated with this study, said the finding that increased body fat was associated with reduced brain volumes suggests “a possible mechanism to explain the previously reported associations between obesity and cognition.”

“Though some degree of atrophy and brain shrinkage is common with old age, awareness of this association is important because reduced brain volume may be associated with problems with thinking, memory, and performing everyday tasks, and because rates of obesity continue to rise in the United States, along with obesity-related conditions including heart disease, stroke, type 2 diabetes and certain types of cancer,” she added.

“While a helpful addition to the literature, the study does have important limitations. As an observational study, it cannot establish whether higher levels of body fat directly causes reduced brain volumes,” Dr. Sexton cautioned.

In addition, the study did not take into account important related factors like physical activity and diet, which may influence any relationship between body fat and brain volumes, she noted. “Overall, it is not just one factor that is important to consider when considering risk for cognitive decline and dementia, but multiple factors.

“Obesity and the location of body fat must be considered in combination with one’s total lived experience and habits, including physical activity, education, head injury, sleep, mental health, and the health of your heart/cardiovascular system and other key bodily systems,” Dr. Sexton said.

The Alzheimer’s Association is leading a 2-year clinical trial known as U.S. POINTER to see whether combining physical activity, healthy nutrition, social and intellectual challenges, and improved self-management of medical conditions can protect cognitive function in older adults who are at increased risk for cognitive decline.

This work was supported in part by Providence St. Joseph Health in Seattle; Saint John’s Health Center Foundation; Pacific Neuroscience Institute and Foundation; Will and Cary Singleton; and the McLoughlin family. Dr. Raji is a consultant for Brainreader, Apollo Health, Voxelwise, Neurevolution, Pacific Neuroscience Institute Foundation, and Icometrix. Dr. Sexton reports no relevant financial relationships.

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

New research provides strong evidence of an association between abdominal fat and reduced brain volumes, particularly those involved with cognitive function.

In a large study of healthy middle-aged adults, greater visceral and subcutaneous abdominal fat on abdominal MRI predicted brain atrophy on imaging, especially in women.

“The study shows that excess fat is bad for the brain and worse in women, including in Alzheimer’s disease risk regions,” lead author Cyrus Raji, MD, PhD, with the Mallinckrodt Institute of Radiology, Washington University, St. Louis, Mo., said in an interview.

The study was published online in the journal Aging and Disease
 

Modifiable risk factor

Multiple studies have suggested a connection between body fat accumulation and increased dementia risk. But few have examined the relationship between types of fat (visceral and subcutaneous) and brain volume.

For the new study, 10,000 healthy adults aged 20-80 years (mean age, 52.9 years; 53% men) underwent a short whole-body MRI protocol. Regression analyses of abdominal fat types and normalized brain volumes were evaluated, controlling for age and sex.

The research team found that higher amounts of both visceral and subcutaneous abdominal fat predicted lower total gray and white matter volume, as well as lower volume in the hippocampus, frontal cortex, and temporal, parietal, and occipital lobes.

“The findings are quite dramatic,” Dr. Raji told this news organization. “Overall, we found that both subcutaneous and visceral fat has similar levels of negative relationships with brain volumes.”

Women had a higher burden of brain atrophy with increased visceral fat than men. However, it’s difficult to place the sex differences in context because of the lack of prior work specifically investigating visceral fat, brain volume loss, and sex differences, the researchers caution.

They also note that while statistically significant relationships were observed between visceral fat levels and gray matter volume changes, their effect sizes were generally small. 

“Thus, the statistical significance of this work is influenced by the large sample size and less so by large effect size in any given set of regions,” the investigators write.

Other limitations include the cross-sectional nature of the study, which precludes conclusions about causality. The analysis also did not account for other lifestyle factors such as physical activity, diet, and genetic variables.

The researchers call for further investigation “to better elucidate underlying mechanisms and discover possible interventions targeting abdominal fat reduction as a strategy to maintain brain health.”
 

‘Helpful addition to the literature’

In a comment, Claire Sexton, DPhil, Alzheimer’s Association senior director of scientific programs and outreach, noted that “previous studies have linked obesity with cognitive decline and increased risk of dementia. Rather than using BMI as a proxy for body fat, the current study examined visceral and subcutaneous fat directly using imaging techniques.”

Dr. Sexton, who was not associated with this study, said the finding that increased body fat was associated with reduced brain volumes suggests “a possible mechanism to explain the previously reported associations between obesity and cognition.”

“Though some degree of atrophy and brain shrinkage is common with old age, awareness of this association is important because reduced brain volume may be associated with problems with thinking, memory, and performing everyday tasks, and because rates of obesity continue to rise in the United States, along with obesity-related conditions including heart disease, stroke, type 2 diabetes and certain types of cancer,” she added.

“While a helpful addition to the literature, the study does have important limitations. As an observational study, it cannot establish whether higher levels of body fat directly causes reduced brain volumes,” Dr. Sexton cautioned.

In addition, the study did not take into account important related factors like physical activity and diet, which may influence any relationship between body fat and brain volumes, she noted. “Overall, it is not just one factor that is important to consider when considering risk for cognitive decline and dementia, but multiple factors.

“Obesity and the location of body fat must be considered in combination with one’s total lived experience and habits, including physical activity, education, head injury, sleep, mental health, and the health of your heart/cardiovascular system and other key bodily systems,” Dr. Sexton said.

The Alzheimer’s Association is leading a 2-year clinical trial known as U.S. POINTER to see whether combining physical activity, healthy nutrition, social and intellectual challenges, and improved self-management of medical conditions can protect cognitive function in older adults who are at increased risk for cognitive decline.

This work was supported in part by Providence St. Joseph Health in Seattle; Saint John’s Health Center Foundation; Pacific Neuroscience Institute and Foundation; Will and Cary Singleton; and the McLoughlin family. Dr. Raji is a consultant for Brainreader, Apollo Health, Voxelwise, Neurevolution, Pacific Neuroscience Institute Foundation, and Icometrix. Dr. Sexton reports no relevant financial relationships.

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