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Obesity boosts gestational diabetes risk in women with PCOS
In a population-based cohort study that included more than 1.2 million hospital live births, PCOS was associated with a 5% increase in risk for gestational diabetes. Almost 90% of this association was mediated by obesity.
“Women with PCOS are at higher risk, but it’s only 5% higher than the general population. However, that risk rises substantially with obesity,” senior author Maria P. Velez, MD, PhD, clinician-scientist and associate professor of obstetrics and gynecology at Queen’s University, Kingston, Ont., said in an interview. “Our study highlights the need for counseling our patients about the importance of weight optimization, ideally starting with lifestyle changes like diet and exercise.”The findings were published in the Journal of Obstetrics and Gynaecology Canada.
Major mediator
The estimated prevalence of PCOS is 8%-13%, and affected patients often present with anovulation, hyperandrogenism, obesity, metabolic syndrome, and infertility. Prepregnancy insulin resistance is common among women with PCOS and may play a major part in the pathogenesis of gestational diabetes. In addition, PCOS is often accompanied by excess weight gain; about 60% of women with PCOS are overweight or obese.
Previous research has shown that PCOS is a risk factor for gestational diabetes independent of obesity, while other research has shown that obesity has an important effect on this risk.
For the current study, the researchers used causal mediation analysis to elucidate more clearly the effect of obesity on the development of gestational diabetes among patients with PCOS. No previous study has used causal mediation analysis to examine this relationship.
Using data from linked universal health databases in Ontario, the researchers analyzed data on 1,268,901 births between 2006 and 2018. Of these births, 386,748 were associated with maternal PCOS.
The rate of gestational diabetes was higher among women with PCOS (60.2 per 1000 births), compared with women without PCOS (48.6 per 1,000 births). The finding resulted in an adjusted relative risk of 1.05. Obesity mediated 89.7% of this association.
“We hope that these data will inform preconception counseling and gestational diabetes screening in pregnant women with PCOS,” said Dr. Velez. “We have the data now to counsel our patients on the importance of weight management before pregnancy. But we need more resources, such as specialized clinics, to help these patients cope with managing their weight. We can tell our patients to work on their weight management, but they need much more support from the health care system.”
Results ‘not surprising’
Commenting on the study, Francine Hippolyte, MD, vice chair of obstetrics and gynecology at Long Island Jewish Medical Center, Katz Women’s Hospital, New Hyde Park, N.Y., said that the results are “not at all surprising.” Dr. Hippolyte was not involved in the research.
“We do know that PCOS is and should be treated as a metabolic syndrome. It’s a lot more than just infertility or changes or abnormalities with one’s menstrual cycle. It impacts a woman’s risk for diabetes, prediabetes, and abnormal lipid profile, regardless of whether or not she is obese,” said Dr. Hippolyte.
She agrees with the need for specialized clinics to help such vulnerable patients manage their weight.
“It would be great if insurances would cover things like nutritional counseling or have nutritionists on their roster so that patients can easily access that service. Many patients want to do right, especially preconceptually, but it is difficult without having access to resources. Unfortunately, as clinicians, we’re not as well versed in nutrition as we would like to be or should be, so we need a multidisciplinary approach. We need nutrition and weight loss clinics and proper services to really help these patients.”
The study was supported by the Canadian Institute of Health Research and ICES. Dr. Velez and Dr. Hippolyte reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a population-based cohort study that included more than 1.2 million hospital live births, PCOS was associated with a 5% increase in risk for gestational diabetes. Almost 90% of this association was mediated by obesity.
“Women with PCOS are at higher risk, but it’s only 5% higher than the general population. However, that risk rises substantially with obesity,” senior author Maria P. Velez, MD, PhD, clinician-scientist and associate professor of obstetrics and gynecology at Queen’s University, Kingston, Ont., said in an interview. “Our study highlights the need for counseling our patients about the importance of weight optimization, ideally starting with lifestyle changes like diet and exercise.”The findings were published in the Journal of Obstetrics and Gynaecology Canada.
Major mediator
The estimated prevalence of PCOS is 8%-13%, and affected patients often present with anovulation, hyperandrogenism, obesity, metabolic syndrome, and infertility. Prepregnancy insulin resistance is common among women with PCOS and may play a major part in the pathogenesis of gestational diabetes. In addition, PCOS is often accompanied by excess weight gain; about 60% of women with PCOS are overweight or obese.
Previous research has shown that PCOS is a risk factor for gestational diabetes independent of obesity, while other research has shown that obesity has an important effect on this risk.
For the current study, the researchers used causal mediation analysis to elucidate more clearly the effect of obesity on the development of gestational diabetes among patients with PCOS. No previous study has used causal mediation analysis to examine this relationship.
Using data from linked universal health databases in Ontario, the researchers analyzed data on 1,268,901 births between 2006 and 2018. Of these births, 386,748 were associated with maternal PCOS.
The rate of gestational diabetes was higher among women with PCOS (60.2 per 1000 births), compared with women without PCOS (48.6 per 1,000 births). The finding resulted in an adjusted relative risk of 1.05. Obesity mediated 89.7% of this association.
“We hope that these data will inform preconception counseling and gestational diabetes screening in pregnant women with PCOS,” said Dr. Velez. “We have the data now to counsel our patients on the importance of weight management before pregnancy. But we need more resources, such as specialized clinics, to help these patients cope with managing their weight. We can tell our patients to work on their weight management, but they need much more support from the health care system.”
Results ‘not surprising’
Commenting on the study, Francine Hippolyte, MD, vice chair of obstetrics and gynecology at Long Island Jewish Medical Center, Katz Women’s Hospital, New Hyde Park, N.Y., said that the results are “not at all surprising.” Dr. Hippolyte was not involved in the research.
“We do know that PCOS is and should be treated as a metabolic syndrome. It’s a lot more than just infertility or changes or abnormalities with one’s menstrual cycle. It impacts a woman’s risk for diabetes, prediabetes, and abnormal lipid profile, regardless of whether or not she is obese,” said Dr. Hippolyte.
She agrees with the need for specialized clinics to help such vulnerable patients manage their weight.
“It would be great if insurances would cover things like nutritional counseling or have nutritionists on their roster so that patients can easily access that service. Many patients want to do right, especially preconceptually, but it is difficult without having access to resources. Unfortunately, as clinicians, we’re not as well versed in nutrition as we would like to be or should be, so we need a multidisciplinary approach. We need nutrition and weight loss clinics and proper services to really help these patients.”
The study was supported by the Canadian Institute of Health Research and ICES. Dr. Velez and Dr. Hippolyte reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a population-based cohort study that included more than 1.2 million hospital live births, PCOS was associated with a 5% increase in risk for gestational diabetes. Almost 90% of this association was mediated by obesity.
“Women with PCOS are at higher risk, but it’s only 5% higher than the general population. However, that risk rises substantially with obesity,” senior author Maria P. Velez, MD, PhD, clinician-scientist and associate professor of obstetrics and gynecology at Queen’s University, Kingston, Ont., said in an interview. “Our study highlights the need for counseling our patients about the importance of weight optimization, ideally starting with lifestyle changes like diet and exercise.”The findings were published in the Journal of Obstetrics and Gynaecology Canada.
Major mediator
The estimated prevalence of PCOS is 8%-13%, and affected patients often present with anovulation, hyperandrogenism, obesity, metabolic syndrome, and infertility. Prepregnancy insulin resistance is common among women with PCOS and may play a major part in the pathogenesis of gestational diabetes. In addition, PCOS is often accompanied by excess weight gain; about 60% of women with PCOS are overweight or obese.
Previous research has shown that PCOS is a risk factor for gestational diabetes independent of obesity, while other research has shown that obesity has an important effect on this risk.
For the current study, the researchers used causal mediation analysis to elucidate more clearly the effect of obesity on the development of gestational diabetes among patients with PCOS. No previous study has used causal mediation analysis to examine this relationship.
Using data from linked universal health databases in Ontario, the researchers analyzed data on 1,268,901 births between 2006 and 2018. Of these births, 386,748 were associated with maternal PCOS.
The rate of gestational diabetes was higher among women with PCOS (60.2 per 1000 births), compared with women without PCOS (48.6 per 1,000 births). The finding resulted in an adjusted relative risk of 1.05. Obesity mediated 89.7% of this association.
“We hope that these data will inform preconception counseling and gestational diabetes screening in pregnant women with PCOS,” said Dr. Velez. “We have the data now to counsel our patients on the importance of weight management before pregnancy. But we need more resources, such as specialized clinics, to help these patients cope with managing their weight. We can tell our patients to work on their weight management, but they need much more support from the health care system.”
Results ‘not surprising’
Commenting on the study, Francine Hippolyte, MD, vice chair of obstetrics and gynecology at Long Island Jewish Medical Center, Katz Women’s Hospital, New Hyde Park, N.Y., said that the results are “not at all surprising.” Dr. Hippolyte was not involved in the research.
“We do know that PCOS is and should be treated as a metabolic syndrome. It’s a lot more than just infertility or changes or abnormalities with one’s menstrual cycle. It impacts a woman’s risk for diabetes, prediabetes, and abnormal lipid profile, regardless of whether or not she is obese,” said Dr. Hippolyte.
She agrees with the need for specialized clinics to help such vulnerable patients manage their weight.
“It would be great if insurances would cover things like nutritional counseling or have nutritionists on their roster so that patients can easily access that service. Many patients want to do right, especially preconceptually, but it is difficult without having access to resources. Unfortunately, as clinicians, we’re not as well versed in nutrition as we would like to be or should be, so we need a multidisciplinary approach. We need nutrition and weight loss clinics and proper services to really help these patients.”
The study was supported by the Canadian Institute of Health Research and ICES. Dr. Velez and Dr. Hippolyte reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JOURNAL OF OBSTETRICS AND GYNAECOLOGY CANADA
Adolescents’ acute care use for eating disorders has risen
In a repeated cross-sectional study that examined population-based data from January 2017 through August 2022, ED visits increased by 121% above expected levels, and hospital admissions increased by 54% above expected among patients aged 10-17 years during the pandemic.
“We are hoping this study continues to heighten awareness of the importance of eating disorders, and also to bolster support for eating disorder programs so that we can adequately care for patients and address the increasing demand for treatment and services,” lead author Alene Toulany, MD, adolescent medicine specialist and researcher at the Hospital for Sick Children in Toronto, told this news organization.
The study was published in the Canadian Medical Association Journal.
‘A pressing concern’
The researchers used linked health administrative databases that included all patients in Ontario who were eligible for the Ontario Health Insurance Plan, which is publicly funded. They compared observed and expected rates of ED visits and hospitalizations for eating disorders between a prepandemic period (Jan. 1, 2017, to Feb. 29, 2020) and a pandemic period (Mar. 1, 2020, to Aug. 31, 2022). The researchers examined the following four age categories: adolescents (aged 10-17 years), young adults (aged 18-26 years), adults (aged 27-40 years), and older adults (aged 41-105 years).
Among adolescents, the observed rate of ED visits during the 30 pandemic months studied was 7.38 per 100,000 population, compared with 3.33 per 100,000 before the pandemic (incidence rate ratio [IRR], 2.21).
The rate of ED visits among young adults increased by 13% above the expected rate. It reached 2.79 per 100,000, compared with 2.46 per 100,000 in the prepandemic period (IRR, 1.13).
Among older adults, ED visits increased from 0.11 per 100,000 in the prepandemic period to 0.14 per 100,000 in the pandemic period (IRR, 1.15). The rate of ED visits among adults remained approximately the same.
The rate of hospital admissions among adolescents increased by 54% above the expected rate during the pandemic. The observed rate of hospital admissions before the pandemic was 5.74 per 100,000, vs. 8.82 per 100,000 during the pandemic (IRR, 1.54). Hospital admissions remained stable or decreased for the other age groups.
“Eating disorders have increased globally in children and adolescents during COVID,” said Dr. Toulany. “There are a number of risk factors contributing to this pandemic rise, including isolation, more time on social media, decreased access to care (as many in-person services were not available due to the pandemic), as well as fear of getting infected. All of these could contribute to an increased risk of developing an eating disorder or of making an existing one worse.”
Regardless of the cause, more investment in eating disorders research and eating disorder programs for adolescents and adults is needed, she said.
“The pandemic served as a catalyst, because it started to shed light on the prevalence of eating disorders, especially in young people. But it’s very important that we recognize that this has been a long-standing issue and a pressing concern that has been consistently overlooked and underfunded,” said Dr. Toulany.
Surging eating disorders
Commenting on the findings, Victor Fornari, MD, director of child and adolescent psychiatry at Zucker Hillside Hospital/Northwell Health in Glen Oaks, N.Y., said, “Our experience in the United States parallels what is described in this Canadian paper. This was a surge of eating disorders the likes of which I had not experienced in my career.” Dr. Fornari did not participate in the current study.
“I’ve been here for over 40 years, and the average number of our inpatients in our eating disorder program has been three to five and about a dozen patients in our day clinic at any one time. But in the spring of 2020, we surged to 20 inpatients and over 20 day patients,” Dr. Fornari said.
“We can speculate as to the reasons for this,” he continued. “Kids were isolated. School was closed. They spent more time on social media and the Internet. Their sports activities were curtailed. There was anxiety because the guidance that we were all offered to prevent contagion was increasing people’s anxiety about safety and danger. So, I think we saw dramatic rises in eating disorders in the same way we saw dramatic rises in anxiety and depression in adolescents, as well.”
Dr. Fornari cited social media as an important contributing factor to eating disorders, especially among vulnerable teenagers. “Many of these vulnerable kids are looking at pictures of people who are very thin and comparing themselves, feeling inadequate, feeling sad. Social media is one of the reasons why the rates of psychopathology amongst teens has skyrocketed in the last decade. The surgeon general recently said we should delay access to social media until age 16 because the younger kids are impressionable and vulnerable. I think there is wisdom there, but it is very hard to actually put into practice.”
Worsening mental health
“I thought this was very relevant research and an important contribution to our understanding of eating disorders during pandemic times,” said Simon Sherry, PhD, professor of psychology and neuroscience at Dalhousie University in Halifax, Nova Scotia. “It also dovetails with my own experience as a practitioner.” Dr. Sherry was not involved in the research.
The pandemic has been difficult for people with disordered eating for many reasons, Dr. Sherry said. “There was a massive disruption or ‘loss of normal’ around food. Restaurants closed, grocery shopping was disrupted, scarcity of food occurred, hoarding of food occurred. That meant that eating was difficult for all of us, but especially for individuals who were rigid and controlling around the consumption of food. In this COVID era, you would need flexibility and acceptance around eating, but if you had a narrow range of preferred foods and preferred shopping locations, no doubt the pandemic made this a lot worse.”
Certain forms of disordered eating would be much more likely during the pandemic, Dr. Sherry noted. “For example, binge eating is often triggered by psychological, social, and environmental events,” and those triggers were abundant at the beginning of the pandemic. Boredom, anxiety, depression, stress, loneliness, confinement, and isolation are among the triggers. “COVID-19-related stress was and is very fertile ground for the growth of emotional eating, binge eating, or turning to food to cope. Eating disorders tend to fester amid silence and isolation and inactivity, and that was very much our experience during the lockdown phase of the pandemic,” he said.
Dr. Sherry agrees with the need for more funding for eating disorders research. “We know in Canada that eating disorders are a very important and deadly issue that is chronically underfunded. We are not funding disordered eating in proportion to its prevalence or in proportion to the amount of harm and destruction it creates for individuals, their family members, and our society at large. The authors are absolutely correct to advocate for care in proportion to the prevalence and the damage associated with eating disorders,” he said.
The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health, the Ministry of Long-Term Care, and the Canadian Institutes of Health Research (CIHR). Dr. Toulany, Dr. Fornari, and Dr. Sherry reported no relevant financial relationships. One study author reported receiving personal fees from the BMJ Group’s Archives of Diseases in Childhood and grants from CIHR, the Ontario Ministry of Health, the Centre for Addiction and Mental Health, and the Hospital for Sick Children. A second author reported funding from CIHR.
A version of this article first appeared on Medscape.com.
In a repeated cross-sectional study that examined population-based data from January 2017 through August 2022, ED visits increased by 121% above expected levels, and hospital admissions increased by 54% above expected among patients aged 10-17 years during the pandemic.
“We are hoping this study continues to heighten awareness of the importance of eating disorders, and also to bolster support for eating disorder programs so that we can adequately care for patients and address the increasing demand for treatment and services,” lead author Alene Toulany, MD, adolescent medicine specialist and researcher at the Hospital for Sick Children in Toronto, told this news organization.
The study was published in the Canadian Medical Association Journal.
‘A pressing concern’
The researchers used linked health administrative databases that included all patients in Ontario who were eligible for the Ontario Health Insurance Plan, which is publicly funded. They compared observed and expected rates of ED visits and hospitalizations for eating disorders between a prepandemic period (Jan. 1, 2017, to Feb. 29, 2020) and a pandemic period (Mar. 1, 2020, to Aug. 31, 2022). The researchers examined the following four age categories: adolescents (aged 10-17 years), young adults (aged 18-26 years), adults (aged 27-40 years), and older adults (aged 41-105 years).
Among adolescents, the observed rate of ED visits during the 30 pandemic months studied was 7.38 per 100,000 population, compared with 3.33 per 100,000 before the pandemic (incidence rate ratio [IRR], 2.21).
The rate of ED visits among young adults increased by 13% above the expected rate. It reached 2.79 per 100,000, compared with 2.46 per 100,000 in the prepandemic period (IRR, 1.13).
Among older adults, ED visits increased from 0.11 per 100,000 in the prepandemic period to 0.14 per 100,000 in the pandemic period (IRR, 1.15). The rate of ED visits among adults remained approximately the same.
The rate of hospital admissions among adolescents increased by 54% above the expected rate during the pandemic. The observed rate of hospital admissions before the pandemic was 5.74 per 100,000, vs. 8.82 per 100,000 during the pandemic (IRR, 1.54). Hospital admissions remained stable or decreased for the other age groups.
“Eating disorders have increased globally in children and adolescents during COVID,” said Dr. Toulany. “There are a number of risk factors contributing to this pandemic rise, including isolation, more time on social media, decreased access to care (as many in-person services were not available due to the pandemic), as well as fear of getting infected. All of these could contribute to an increased risk of developing an eating disorder or of making an existing one worse.”
Regardless of the cause, more investment in eating disorders research and eating disorder programs for adolescents and adults is needed, she said.
“The pandemic served as a catalyst, because it started to shed light on the prevalence of eating disorders, especially in young people. But it’s very important that we recognize that this has been a long-standing issue and a pressing concern that has been consistently overlooked and underfunded,” said Dr. Toulany.
Surging eating disorders
Commenting on the findings, Victor Fornari, MD, director of child and adolescent psychiatry at Zucker Hillside Hospital/Northwell Health in Glen Oaks, N.Y., said, “Our experience in the United States parallels what is described in this Canadian paper. This was a surge of eating disorders the likes of which I had not experienced in my career.” Dr. Fornari did not participate in the current study.
“I’ve been here for over 40 years, and the average number of our inpatients in our eating disorder program has been three to five and about a dozen patients in our day clinic at any one time. But in the spring of 2020, we surged to 20 inpatients and over 20 day patients,” Dr. Fornari said.
“We can speculate as to the reasons for this,” he continued. “Kids were isolated. School was closed. They spent more time on social media and the Internet. Their sports activities were curtailed. There was anxiety because the guidance that we were all offered to prevent contagion was increasing people’s anxiety about safety and danger. So, I think we saw dramatic rises in eating disorders in the same way we saw dramatic rises in anxiety and depression in adolescents, as well.”
Dr. Fornari cited social media as an important contributing factor to eating disorders, especially among vulnerable teenagers. “Many of these vulnerable kids are looking at pictures of people who are very thin and comparing themselves, feeling inadequate, feeling sad. Social media is one of the reasons why the rates of psychopathology amongst teens has skyrocketed in the last decade. The surgeon general recently said we should delay access to social media until age 16 because the younger kids are impressionable and vulnerable. I think there is wisdom there, but it is very hard to actually put into practice.”
Worsening mental health
“I thought this was very relevant research and an important contribution to our understanding of eating disorders during pandemic times,” said Simon Sherry, PhD, professor of psychology and neuroscience at Dalhousie University in Halifax, Nova Scotia. “It also dovetails with my own experience as a practitioner.” Dr. Sherry was not involved in the research.
The pandemic has been difficult for people with disordered eating for many reasons, Dr. Sherry said. “There was a massive disruption or ‘loss of normal’ around food. Restaurants closed, grocery shopping was disrupted, scarcity of food occurred, hoarding of food occurred. That meant that eating was difficult for all of us, but especially for individuals who were rigid and controlling around the consumption of food. In this COVID era, you would need flexibility and acceptance around eating, but if you had a narrow range of preferred foods and preferred shopping locations, no doubt the pandemic made this a lot worse.”
Certain forms of disordered eating would be much more likely during the pandemic, Dr. Sherry noted. “For example, binge eating is often triggered by psychological, social, and environmental events,” and those triggers were abundant at the beginning of the pandemic. Boredom, anxiety, depression, stress, loneliness, confinement, and isolation are among the triggers. “COVID-19-related stress was and is very fertile ground for the growth of emotional eating, binge eating, or turning to food to cope. Eating disorders tend to fester amid silence and isolation and inactivity, and that was very much our experience during the lockdown phase of the pandemic,” he said.
Dr. Sherry agrees with the need for more funding for eating disorders research. “We know in Canada that eating disorders are a very important and deadly issue that is chronically underfunded. We are not funding disordered eating in proportion to its prevalence or in proportion to the amount of harm and destruction it creates for individuals, their family members, and our society at large. The authors are absolutely correct to advocate for care in proportion to the prevalence and the damage associated with eating disorders,” he said.
The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health, the Ministry of Long-Term Care, and the Canadian Institutes of Health Research (CIHR). Dr. Toulany, Dr. Fornari, and Dr. Sherry reported no relevant financial relationships. One study author reported receiving personal fees from the BMJ Group’s Archives of Diseases in Childhood and grants from CIHR, the Ontario Ministry of Health, the Centre for Addiction and Mental Health, and the Hospital for Sick Children. A second author reported funding from CIHR.
A version of this article first appeared on Medscape.com.
In a repeated cross-sectional study that examined population-based data from January 2017 through August 2022, ED visits increased by 121% above expected levels, and hospital admissions increased by 54% above expected among patients aged 10-17 years during the pandemic.
“We are hoping this study continues to heighten awareness of the importance of eating disorders, and also to bolster support for eating disorder programs so that we can adequately care for patients and address the increasing demand for treatment and services,” lead author Alene Toulany, MD, adolescent medicine specialist and researcher at the Hospital for Sick Children in Toronto, told this news organization.
The study was published in the Canadian Medical Association Journal.
‘A pressing concern’
The researchers used linked health administrative databases that included all patients in Ontario who were eligible for the Ontario Health Insurance Plan, which is publicly funded. They compared observed and expected rates of ED visits and hospitalizations for eating disorders between a prepandemic period (Jan. 1, 2017, to Feb. 29, 2020) and a pandemic period (Mar. 1, 2020, to Aug. 31, 2022). The researchers examined the following four age categories: adolescents (aged 10-17 years), young adults (aged 18-26 years), adults (aged 27-40 years), and older adults (aged 41-105 years).
Among adolescents, the observed rate of ED visits during the 30 pandemic months studied was 7.38 per 100,000 population, compared with 3.33 per 100,000 before the pandemic (incidence rate ratio [IRR], 2.21).
The rate of ED visits among young adults increased by 13% above the expected rate. It reached 2.79 per 100,000, compared with 2.46 per 100,000 in the prepandemic period (IRR, 1.13).
Among older adults, ED visits increased from 0.11 per 100,000 in the prepandemic period to 0.14 per 100,000 in the pandemic period (IRR, 1.15). The rate of ED visits among adults remained approximately the same.
The rate of hospital admissions among adolescents increased by 54% above the expected rate during the pandemic. The observed rate of hospital admissions before the pandemic was 5.74 per 100,000, vs. 8.82 per 100,000 during the pandemic (IRR, 1.54). Hospital admissions remained stable or decreased for the other age groups.
“Eating disorders have increased globally in children and adolescents during COVID,” said Dr. Toulany. “There are a number of risk factors contributing to this pandemic rise, including isolation, more time on social media, decreased access to care (as many in-person services were not available due to the pandemic), as well as fear of getting infected. All of these could contribute to an increased risk of developing an eating disorder or of making an existing one worse.”
Regardless of the cause, more investment in eating disorders research and eating disorder programs for adolescents and adults is needed, she said.
“The pandemic served as a catalyst, because it started to shed light on the prevalence of eating disorders, especially in young people. But it’s very important that we recognize that this has been a long-standing issue and a pressing concern that has been consistently overlooked and underfunded,” said Dr. Toulany.
Surging eating disorders
Commenting on the findings, Victor Fornari, MD, director of child and adolescent psychiatry at Zucker Hillside Hospital/Northwell Health in Glen Oaks, N.Y., said, “Our experience in the United States parallels what is described in this Canadian paper. This was a surge of eating disorders the likes of which I had not experienced in my career.” Dr. Fornari did not participate in the current study.
“I’ve been here for over 40 years, and the average number of our inpatients in our eating disorder program has been three to five and about a dozen patients in our day clinic at any one time. But in the spring of 2020, we surged to 20 inpatients and over 20 day patients,” Dr. Fornari said.
“We can speculate as to the reasons for this,” he continued. “Kids were isolated. School was closed. They spent more time on social media and the Internet. Their sports activities were curtailed. There was anxiety because the guidance that we were all offered to prevent contagion was increasing people’s anxiety about safety and danger. So, I think we saw dramatic rises in eating disorders in the same way we saw dramatic rises in anxiety and depression in adolescents, as well.”
Dr. Fornari cited social media as an important contributing factor to eating disorders, especially among vulnerable teenagers. “Many of these vulnerable kids are looking at pictures of people who are very thin and comparing themselves, feeling inadequate, feeling sad. Social media is one of the reasons why the rates of psychopathology amongst teens has skyrocketed in the last decade. The surgeon general recently said we should delay access to social media until age 16 because the younger kids are impressionable and vulnerable. I think there is wisdom there, but it is very hard to actually put into practice.”
Worsening mental health
“I thought this was very relevant research and an important contribution to our understanding of eating disorders during pandemic times,” said Simon Sherry, PhD, professor of psychology and neuroscience at Dalhousie University in Halifax, Nova Scotia. “It also dovetails with my own experience as a practitioner.” Dr. Sherry was not involved in the research.
The pandemic has been difficult for people with disordered eating for many reasons, Dr. Sherry said. “There was a massive disruption or ‘loss of normal’ around food. Restaurants closed, grocery shopping was disrupted, scarcity of food occurred, hoarding of food occurred. That meant that eating was difficult for all of us, but especially for individuals who were rigid and controlling around the consumption of food. In this COVID era, you would need flexibility and acceptance around eating, but if you had a narrow range of preferred foods and preferred shopping locations, no doubt the pandemic made this a lot worse.”
Certain forms of disordered eating would be much more likely during the pandemic, Dr. Sherry noted. “For example, binge eating is often triggered by psychological, social, and environmental events,” and those triggers were abundant at the beginning of the pandemic. Boredom, anxiety, depression, stress, loneliness, confinement, and isolation are among the triggers. “COVID-19-related stress was and is very fertile ground for the growth of emotional eating, binge eating, or turning to food to cope. Eating disorders tend to fester amid silence and isolation and inactivity, and that was very much our experience during the lockdown phase of the pandemic,” he said.
Dr. Sherry agrees with the need for more funding for eating disorders research. “We know in Canada that eating disorders are a very important and deadly issue that is chronically underfunded. We are not funding disordered eating in proportion to its prevalence or in proportion to the amount of harm and destruction it creates for individuals, their family members, and our society at large. The authors are absolutely correct to advocate for care in proportion to the prevalence and the damage associated with eating disorders,” he said.
The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health, the Ministry of Long-Term Care, and the Canadian Institutes of Health Research (CIHR). Dr. Toulany, Dr. Fornari, and Dr. Sherry reported no relevant financial relationships. One study author reported receiving personal fees from the BMJ Group’s Archives of Diseases in Childhood and grants from CIHR, the Ontario Ministry of Health, the Centre for Addiction and Mental Health, and the Hospital for Sick Children. A second author reported funding from CIHR.
A version of this article first appeared on Medscape.com.
FROM THE CANADIAN MEDICAL ASSOCIATION JOURNAL
Does continuity of care affect outcomes after arthroplasty?
according to new research.
In a retrospective cohort study that included more than 45,000 surgeries, the likelihood of visiting the ED within 90 days was 40% lower for patients who had unbroken continuity of primary care before knee replacement and 35% lower for patients who had unbroken continuity of primary care before hip replacement, compared with those who had several primary care clinicians. Continuity of primary care was defined as having one primary care clinician in the 3 years before surgery.
The findings highlight the critical need for improved access to primary care in Canada, lead author Lynn Lethbridge, from the department of surgery at Dalhousie University, Halifax, N.S., said in an interview. “The primary care providers have been aware that continuity of care matters, but I’m not sure that surgeons are,” she said. “If they become aware, the surgical team could develop strategies to help prevent somebody from coming back to the ED by discussing primary care provisions during the presurgical consultation.”
The study was published online in the Canadian Journal of Surgery.
Discontinuity a disadvantage
“There’s been a lot of news for the last few years here in Nova Scotia and all across Canada on the difficulties of getting and keeping a regular primary care provider, and there has also been a lot of coverage about overcrowded emergency departments and efforts to reduce the need for emergency care,” said Ms. Lethbridge. “The number of joint replacement procedures is expected to rise in the coming years, and we wanted to know if there was an association between not having a regular primary care provider and the chance of returning to the ED after joint replacement, so we undertook the study.”
The researchers accessed data on all patients in Nova Scotia who underwent nonemergency hip and knee procedures from 2005 to 2020. The study outcome was any ED visit within 90 days after discharge.
The investigators looked at 3 years of primary care history before surgery and calculated the Modified Modified Continuity Index (MMCI), which represents the number of primary care clinicians adjusted for the total number of visits, for each patient. The maximum value of the MMCI is 1, meaning that the patient saw the same doctor throughout the period examined. Lower scores mean that the patient saw different health care providers during that period.
Of the patients who underwent the 28,574 knee procedures included in the analysis, 13.9% had an ED visit within 90 days. Of the patients who underwent the 16,767 hip procedures included in the analysis, 13.5% had an ED visit within 90 days.
For patients undergoing knee procedures, the mean MMCI was 0.868, and 10.7% of patients had a perfect MMCI score of 1. For patients undergoing hip replacement, the mean MMCI was 0.864, and 13.5% had an MMCI of 1.
After controlling for confounders such as age, comorbidities, distance to hospital, and neighborhood income, the researchers found a statistically significant negative association between greater continuity of care and the probability of an ED visit.
A knee replacement patient with an MMCI score of 1 had a 90-day ED visit probability of 12.8%. A patient who had visited multiple primary care clinicians before surgery had a probability of 15.2%.
‘Quarterbacks’ needed
Commenting on the findings, Harman Chaudhry, MD, MSc, an orthopedic surgeon at Sunnybrook Health Science Center, Toronto, said: “Their main message quantified what many of us in health care already sense is true: That patients do benefit when there’s somebody, specifically a primary care provider, to quarterback their health care, look over the entirety of their care, and really know the patient.
“These are elective procedures, and joint replacement is a very siloed and episodic instance of care where we, as surgeons in hospitals, think we can control a lot of the presurgical and postsurgical care and really optimize patients,” he added. “But it’s clear that despite that, patients are still benefiting from having somebody who has known them for a longer period of time.”
The longstanding shortage of family physicians in Canada has worsened, especially since the beginning of the pandemic. The shortage means that many people are denied access to a family doctor of their own, said Dr. Chaudhry, who was not involved in the research.
“In Canada, there’s a large chunk of the population that is having difficulty accessing a primary care physician, so those patients have created their own primary care experience, taking advantage of walk-in clinics, perhaps urgent care centers, EDs when they need emergency care, and locum [tenens] physicians that may come into the community once in a while. And so, they have created their own primary care experience, but there is not a single person or single medical home where they’ve been seen for a period of years,” he said.
“Many of the patients in this study who were in the ED had nobody that the surgeon could communicate with or send his notes to,” Dr. Chaudhry concluded.
No source of funding for this study was reported. Ms. Lethbridge and Dr. Chaudhry reported no relevant financial relationships. One coauthor received travel support from Stryker and DePuy Synthes, has stock or stock options in Stryker, and participated in a data safety monitoring board for Hip Innovation Technology.
A version of this article first appeared on Medscape.com.
according to new research.
In a retrospective cohort study that included more than 45,000 surgeries, the likelihood of visiting the ED within 90 days was 40% lower for patients who had unbroken continuity of primary care before knee replacement and 35% lower for patients who had unbroken continuity of primary care before hip replacement, compared with those who had several primary care clinicians. Continuity of primary care was defined as having one primary care clinician in the 3 years before surgery.
The findings highlight the critical need for improved access to primary care in Canada, lead author Lynn Lethbridge, from the department of surgery at Dalhousie University, Halifax, N.S., said in an interview. “The primary care providers have been aware that continuity of care matters, but I’m not sure that surgeons are,” she said. “If they become aware, the surgical team could develop strategies to help prevent somebody from coming back to the ED by discussing primary care provisions during the presurgical consultation.”
The study was published online in the Canadian Journal of Surgery.
Discontinuity a disadvantage
“There’s been a lot of news for the last few years here in Nova Scotia and all across Canada on the difficulties of getting and keeping a regular primary care provider, and there has also been a lot of coverage about overcrowded emergency departments and efforts to reduce the need for emergency care,” said Ms. Lethbridge. “The number of joint replacement procedures is expected to rise in the coming years, and we wanted to know if there was an association between not having a regular primary care provider and the chance of returning to the ED after joint replacement, so we undertook the study.”
The researchers accessed data on all patients in Nova Scotia who underwent nonemergency hip and knee procedures from 2005 to 2020. The study outcome was any ED visit within 90 days after discharge.
The investigators looked at 3 years of primary care history before surgery and calculated the Modified Modified Continuity Index (MMCI), which represents the number of primary care clinicians adjusted for the total number of visits, for each patient. The maximum value of the MMCI is 1, meaning that the patient saw the same doctor throughout the period examined. Lower scores mean that the patient saw different health care providers during that period.
Of the patients who underwent the 28,574 knee procedures included in the analysis, 13.9% had an ED visit within 90 days. Of the patients who underwent the 16,767 hip procedures included in the analysis, 13.5% had an ED visit within 90 days.
For patients undergoing knee procedures, the mean MMCI was 0.868, and 10.7% of patients had a perfect MMCI score of 1. For patients undergoing hip replacement, the mean MMCI was 0.864, and 13.5% had an MMCI of 1.
After controlling for confounders such as age, comorbidities, distance to hospital, and neighborhood income, the researchers found a statistically significant negative association between greater continuity of care and the probability of an ED visit.
A knee replacement patient with an MMCI score of 1 had a 90-day ED visit probability of 12.8%. A patient who had visited multiple primary care clinicians before surgery had a probability of 15.2%.
‘Quarterbacks’ needed
Commenting on the findings, Harman Chaudhry, MD, MSc, an orthopedic surgeon at Sunnybrook Health Science Center, Toronto, said: “Their main message quantified what many of us in health care already sense is true: That patients do benefit when there’s somebody, specifically a primary care provider, to quarterback their health care, look over the entirety of their care, and really know the patient.
“These are elective procedures, and joint replacement is a very siloed and episodic instance of care where we, as surgeons in hospitals, think we can control a lot of the presurgical and postsurgical care and really optimize patients,” he added. “But it’s clear that despite that, patients are still benefiting from having somebody who has known them for a longer period of time.”
The longstanding shortage of family physicians in Canada has worsened, especially since the beginning of the pandemic. The shortage means that many people are denied access to a family doctor of their own, said Dr. Chaudhry, who was not involved in the research.
“In Canada, there’s a large chunk of the population that is having difficulty accessing a primary care physician, so those patients have created their own primary care experience, taking advantage of walk-in clinics, perhaps urgent care centers, EDs when they need emergency care, and locum [tenens] physicians that may come into the community once in a while. And so, they have created their own primary care experience, but there is not a single person or single medical home where they’ve been seen for a period of years,” he said.
“Many of the patients in this study who were in the ED had nobody that the surgeon could communicate with or send his notes to,” Dr. Chaudhry concluded.
No source of funding for this study was reported. Ms. Lethbridge and Dr. Chaudhry reported no relevant financial relationships. One coauthor received travel support from Stryker and DePuy Synthes, has stock or stock options in Stryker, and participated in a data safety monitoring board for Hip Innovation Technology.
A version of this article first appeared on Medscape.com.
according to new research.
In a retrospective cohort study that included more than 45,000 surgeries, the likelihood of visiting the ED within 90 days was 40% lower for patients who had unbroken continuity of primary care before knee replacement and 35% lower for patients who had unbroken continuity of primary care before hip replacement, compared with those who had several primary care clinicians. Continuity of primary care was defined as having one primary care clinician in the 3 years before surgery.
The findings highlight the critical need for improved access to primary care in Canada, lead author Lynn Lethbridge, from the department of surgery at Dalhousie University, Halifax, N.S., said in an interview. “The primary care providers have been aware that continuity of care matters, but I’m not sure that surgeons are,” she said. “If they become aware, the surgical team could develop strategies to help prevent somebody from coming back to the ED by discussing primary care provisions during the presurgical consultation.”
The study was published online in the Canadian Journal of Surgery.
Discontinuity a disadvantage
“There’s been a lot of news for the last few years here in Nova Scotia and all across Canada on the difficulties of getting and keeping a regular primary care provider, and there has also been a lot of coverage about overcrowded emergency departments and efforts to reduce the need for emergency care,” said Ms. Lethbridge. “The number of joint replacement procedures is expected to rise in the coming years, and we wanted to know if there was an association between not having a regular primary care provider and the chance of returning to the ED after joint replacement, so we undertook the study.”
The researchers accessed data on all patients in Nova Scotia who underwent nonemergency hip and knee procedures from 2005 to 2020. The study outcome was any ED visit within 90 days after discharge.
The investigators looked at 3 years of primary care history before surgery and calculated the Modified Modified Continuity Index (MMCI), which represents the number of primary care clinicians adjusted for the total number of visits, for each patient. The maximum value of the MMCI is 1, meaning that the patient saw the same doctor throughout the period examined. Lower scores mean that the patient saw different health care providers during that period.
Of the patients who underwent the 28,574 knee procedures included in the analysis, 13.9% had an ED visit within 90 days. Of the patients who underwent the 16,767 hip procedures included in the analysis, 13.5% had an ED visit within 90 days.
For patients undergoing knee procedures, the mean MMCI was 0.868, and 10.7% of patients had a perfect MMCI score of 1. For patients undergoing hip replacement, the mean MMCI was 0.864, and 13.5% had an MMCI of 1.
After controlling for confounders such as age, comorbidities, distance to hospital, and neighborhood income, the researchers found a statistically significant negative association between greater continuity of care and the probability of an ED visit.
A knee replacement patient with an MMCI score of 1 had a 90-day ED visit probability of 12.8%. A patient who had visited multiple primary care clinicians before surgery had a probability of 15.2%.
‘Quarterbacks’ needed
Commenting on the findings, Harman Chaudhry, MD, MSc, an orthopedic surgeon at Sunnybrook Health Science Center, Toronto, said: “Their main message quantified what many of us in health care already sense is true: That patients do benefit when there’s somebody, specifically a primary care provider, to quarterback their health care, look over the entirety of their care, and really know the patient.
“These are elective procedures, and joint replacement is a very siloed and episodic instance of care where we, as surgeons in hospitals, think we can control a lot of the presurgical and postsurgical care and really optimize patients,” he added. “But it’s clear that despite that, patients are still benefiting from having somebody who has known them for a longer period of time.”
The longstanding shortage of family physicians in Canada has worsened, especially since the beginning of the pandemic. The shortage means that many people are denied access to a family doctor of their own, said Dr. Chaudhry, who was not involved in the research.
“In Canada, there’s a large chunk of the population that is having difficulty accessing a primary care physician, so those patients have created their own primary care experience, taking advantage of walk-in clinics, perhaps urgent care centers, EDs when they need emergency care, and locum [tenens] physicians that may come into the community once in a while. And so, they have created their own primary care experience, but there is not a single person or single medical home where they’ve been seen for a period of years,” he said.
“Many of the patients in this study who were in the ED had nobody that the surgeon could communicate with or send his notes to,” Dr. Chaudhry concluded.
No source of funding for this study was reported. Ms. Lethbridge and Dr. Chaudhry reported no relevant financial relationships. One coauthor received travel support from Stryker and DePuy Synthes, has stock or stock options in Stryker, and participated in a data safety monitoring board for Hip Innovation Technology.
A version of this article first appeared on Medscape.com.
FROM THE CANADIAN JOURNAL OF SURGERY
Unique twin study sheds new light on TBI and risk of cognitive decline
The research, which included almost 9,000 individuals, showed that twins who had experienced a TBI were more likely to have lower cognitive function at age 70 versus their twin who did not experience a TBI, especially if they had lost consciousness or were older than age 24 at the time of injury. In addition, their cognitive decline occurred at a more rapid rate.
“We know that TBI increases the risk of developing Alzheimer’s disease and other dementias in later life, but we haven’t known about TBI’s effect on cognitive decline that does not quite meet the threshold for dementia,” study investigator Marianne Chanti-Ketterl, PhD, Duke University, Durham, N.C., said in an interview.
“We know that TBI increases the risk of dementia in later life, but we haven’t known if TBI affects cognitive function, causes cognitive decline that has not progressed to the point of severity with Alzheimer’s or dementia,” she added.
Being able to study the impact of TBI in monozygotic twins gives this study a unique strength, she noted.
“The important thing about this is that they are monozygotic twins, and we know they shared a lot of early life exposure, and almost 100% genetics,” Dr. Chanti-Ketterl said.
The study was published online in Neurology.
For the study, the investigators assessed 8,662 participants born between 1917 and 1927 who were part of the National Academy of Sciences National Research Council’s Twin Registry. The registry is composed of male veterans of World War II with a history of TBI, as reported by themselves or a caregiver.
The men were followed up for many years as part of the registry, but cognitive assessment only began in the 1990s. They were followed up at four different time points, at which time the Telephone Interview for Cognitive Status (TICS-m), an alternative to the Mini-Mental State Examination that must be given in person, was administered.
A total of 25% of participants had experienced concussion in their lifetime. Of this cohort, there were 589 pairs of monozygotic twins who were discordant (one twin had TBI and the other had not).
Among the monozygotic twin cohort, a history of any TBI and being older than age 24 at the time of TBI were associated with lower TICS-m scores.
A twin who experienced TBI after age 24 scored 0.59 points lower on the TICS-m at age 70 than his twin with no TBI, and cognitive function declined faster, by 0.05 points per year.
First study of its kind
Holly Elser, MD, PhD, MPH, an epidemiologist and resident physician in neurology at the University of Pennsylvania, Philadelphia, and coauthor of an accompanying editorial, said in an interview that the study’s twin design was a definite strength.
“There are lots of papers that have remarked on the apparent association between head injury and subsequent dementia or cognitive decline, but to my knowledge, this is one of the first, if not the first, to use a twin study design, which has the unique advantage of having better control over early life and genetic factors than would ever typically be possible in a dataset of unrelated adults,” said Dr. Elser.
She added that the study findings “strengthen our understanding of the relationship between TBI and later cognitive decline, so I think there is an etiologic value to the study.”
However, Dr. Elser noted that the composition of the study population may limit the extent to which the results apply to contemporary populations.
“This was a population of White male twins born between 1917 and 1927,” she noted. “However, does the experience of people who were in the military generalize to civilian populations? Are twins representative of the general population or are they unique in terms of their risk factors?”
It is always important to emphasize inclusivity in clinical research, and in dementia research in particular, Dr. Elser added.
“There are many examples of instances where racialized and otherwise economically marginalized groups have been excluded from analysis, which is problematic because there are already economically and socially marginalized groups who disproportionately bear the brunt of dementia.
“This is not a criticism of the authors’ work, that their data didn’t include a more diverse patient base, but I think it is an important reminder that we should always interpret study findings within the limitations of the data. It’s a reminder to be thoughtful about taking explicit steps to include more diverse groups in future research,” she said.
The study was funded by the National Institute on Aging/National Institutes of Health and the Department of Defense. Dr. Chanti-Ketterl and Dr. Elser have reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
The research, which included almost 9,000 individuals, showed that twins who had experienced a TBI were more likely to have lower cognitive function at age 70 versus their twin who did not experience a TBI, especially if they had lost consciousness or were older than age 24 at the time of injury. In addition, their cognitive decline occurred at a more rapid rate.
“We know that TBI increases the risk of developing Alzheimer’s disease and other dementias in later life, but we haven’t known about TBI’s effect on cognitive decline that does not quite meet the threshold for dementia,” study investigator Marianne Chanti-Ketterl, PhD, Duke University, Durham, N.C., said in an interview.
“We know that TBI increases the risk of dementia in later life, but we haven’t known if TBI affects cognitive function, causes cognitive decline that has not progressed to the point of severity with Alzheimer’s or dementia,” she added.
Being able to study the impact of TBI in monozygotic twins gives this study a unique strength, she noted.
“The important thing about this is that they are monozygotic twins, and we know they shared a lot of early life exposure, and almost 100% genetics,” Dr. Chanti-Ketterl said.
The study was published online in Neurology.
For the study, the investigators assessed 8,662 participants born between 1917 and 1927 who were part of the National Academy of Sciences National Research Council’s Twin Registry. The registry is composed of male veterans of World War II with a history of TBI, as reported by themselves or a caregiver.
The men were followed up for many years as part of the registry, but cognitive assessment only began in the 1990s. They were followed up at four different time points, at which time the Telephone Interview for Cognitive Status (TICS-m), an alternative to the Mini-Mental State Examination that must be given in person, was administered.
A total of 25% of participants had experienced concussion in their lifetime. Of this cohort, there were 589 pairs of monozygotic twins who were discordant (one twin had TBI and the other had not).
Among the monozygotic twin cohort, a history of any TBI and being older than age 24 at the time of TBI were associated with lower TICS-m scores.
A twin who experienced TBI after age 24 scored 0.59 points lower on the TICS-m at age 70 than his twin with no TBI, and cognitive function declined faster, by 0.05 points per year.
First study of its kind
Holly Elser, MD, PhD, MPH, an epidemiologist and resident physician in neurology at the University of Pennsylvania, Philadelphia, and coauthor of an accompanying editorial, said in an interview that the study’s twin design was a definite strength.
“There are lots of papers that have remarked on the apparent association between head injury and subsequent dementia or cognitive decline, but to my knowledge, this is one of the first, if not the first, to use a twin study design, which has the unique advantage of having better control over early life and genetic factors than would ever typically be possible in a dataset of unrelated adults,” said Dr. Elser.
She added that the study findings “strengthen our understanding of the relationship between TBI and later cognitive decline, so I think there is an etiologic value to the study.”
However, Dr. Elser noted that the composition of the study population may limit the extent to which the results apply to contemporary populations.
“This was a population of White male twins born between 1917 and 1927,” she noted. “However, does the experience of people who were in the military generalize to civilian populations? Are twins representative of the general population or are they unique in terms of their risk factors?”
It is always important to emphasize inclusivity in clinical research, and in dementia research in particular, Dr. Elser added.
“There are many examples of instances where racialized and otherwise economically marginalized groups have been excluded from analysis, which is problematic because there are already economically and socially marginalized groups who disproportionately bear the brunt of dementia.
“This is not a criticism of the authors’ work, that their data didn’t include a more diverse patient base, but I think it is an important reminder that we should always interpret study findings within the limitations of the data. It’s a reminder to be thoughtful about taking explicit steps to include more diverse groups in future research,” she said.
The study was funded by the National Institute on Aging/National Institutes of Health and the Department of Defense. Dr. Chanti-Ketterl and Dr. Elser have reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
The research, which included almost 9,000 individuals, showed that twins who had experienced a TBI were more likely to have lower cognitive function at age 70 versus their twin who did not experience a TBI, especially if they had lost consciousness or were older than age 24 at the time of injury. In addition, their cognitive decline occurred at a more rapid rate.
“We know that TBI increases the risk of developing Alzheimer’s disease and other dementias in later life, but we haven’t known about TBI’s effect on cognitive decline that does not quite meet the threshold for dementia,” study investigator Marianne Chanti-Ketterl, PhD, Duke University, Durham, N.C., said in an interview.
“We know that TBI increases the risk of dementia in later life, but we haven’t known if TBI affects cognitive function, causes cognitive decline that has not progressed to the point of severity with Alzheimer’s or dementia,” she added.
Being able to study the impact of TBI in monozygotic twins gives this study a unique strength, she noted.
“The important thing about this is that they are monozygotic twins, and we know they shared a lot of early life exposure, and almost 100% genetics,” Dr. Chanti-Ketterl said.
The study was published online in Neurology.
For the study, the investigators assessed 8,662 participants born between 1917 and 1927 who were part of the National Academy of Sciences National Research Council’s Twin Registry. The registry is composed of male veterans of World War II with a history of TBI, as reported by themselves or a caregiver.
The men were followed up for many years as part of the registry, but cognitive assessment only began in the 1990s. They were followed up at four different time points, at which time the Telephone Interview for Cognitive Status (TICS-m), an alternative to the Mini-Mental State Examination that must be given in person, was administered.
A total of 25% of participants had experienced concussion in their lifetime. Of this cohort, there were 589 pairs of monozygotic twins who were discordant (one twin had TBI and the other had not).
Among the monozygotic twin cohort, a history of any TBI and being older than age 24 at the time of TBI were associated with lower TICS-m scores.
A twin who experienced TBI after age 24 scored 0.59 points lower on the TICS-m at age 70 than his twin with no TBI, and cognitive function declined faster, by 0.05 points per year.
First study of its kind
Holly Elser, MD, PhD, MPH, an epidemiologist and resident physician in neurology at the University of Pennsylvania, Philadelphia, and coauthor of an accompanying editorial, said in an interview that the study’s twin design was a definite strength.
“There are lots of papers that have remarked on the apparent association between head injury and subsequent dementia or cognitive decline, but to my knowledge, this is one of the first, if not the first, to use a twin study design, which has the unique advantage of having better control over early life and genetic factors than would ever typically be possible in a dataset of unrelated adults,” said Dr. Elser.
She added that the study findings “strengthen our understanding of the relationship between TBI and later cognitive decline, so I think there is an etiologic value to the study.”
However, Dr. Elser noted that the composition of the study population may limit the extent to which the results apply to contemporary populations.
“This was a population of White male twins born between 1917 and 1927,” she noted. “However, does the experience of people who were in the military generalize to civilian populations? Are twins representative of the general population or are they unique in terms of their risk factors?”
It is always important to emphasize inclusivity in clinical research, and in dementia research in particular, Dr. Elser added.
“There are many examples of instances where racialized and otherwise economically marginalized groups have been excluded from analysis, which is problematic because there are already economically and socially marginalized groups who disproportionately bear the brunt of dementia.
“This is not a criticism of the authors’ work, that their data didn’t include a more diverse patient base, but I think it is an important reminder that we should always interpret study findings within the limitations of the data. It’s a reminder to be thoughtful about taking explicit steps to include more diverse groups in future research,” she said.
The study was funded by the National Institute on Aging/National Institutes of Health and the Department of Defense. Dr. Chanti-Ketterl and Dr. Elser have reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM NEUROLOGY
FDA panel split on efficacy of Spyral renal denervation system
The Food and Drug Administration’s Circulatory System Devices Panel unanimously agreed that the Symplicity Spyral Renal Denervation System (Medtronic) is safe, but the panel was split on its efficacy and whether the benefits outweighed the risks associated with its use.
The moderator’s tiebreaker vote went against the benefit-risk profile, for a final vote of 6 yes, 7 no, and 1 abstention.
The Symplicity Spyral system provides a catheter-based approach to denervate the renal arteries using radiofrequency energy. The proposed indication is for reduction of blood pressure in patients with uncontrolled hypertension despite their use of antihypertensive medications, or in patients who cannot tolerate antihypertensive medications.
The Spyral device received breakthrough device designation in March 2020. The FDA determined that the device met the criteria for inclusion in the program because it was a novel technology and had the potential to provide more effective treatment for patients with resistant or uncontrolled hypertension.
Medtronic presented data from two studies, the SPYRAL HTN-OFF and SPYRAL HTN-ON randomized trials.
HTN-OFF enrolled patients with hypertension whose medications could be discontinued at the start of the trial. The primary effectiveness endpoint was the mean difference in the baseline adjusted 24-hour ambulatory systolic blood pressure (ASBP) from baseline to 3 months post renal denervation or sham procedure. The study showed a statistically significant reduction of 3.9 mm Hg ASBP in patients who received the device compared with sham control patients.
HTN-ON evaluated patients with uncontrolled hypertension who continued taking their blood pressure medications during treatment with either the Spyral renal denervation device or a sham device. The primary endpoint was the mean difference in the baseline adjusted 24 hour ambulatory systolic blood pressure at 6 months. The study showed a nonsignificant 24-hour 0.03–mm Hg reduction in ambulatory systolic blood pressure in active-treatment patients compared with sham control patients.
Many on the panel agreed that the device was safe and effective. Randall Starling, MD, professor of medicine in the Heart, Vascular, and Thoracic Institute at Cleveland Clinic, said that he was comfortable with the data presented by Medtronic and that his affirmative vote reflected his recognition that hypertension is not effectively treated with current medications and that another tool in the armamentarium to treat patients is needed.
Matthew Corriere, MD, Frankel Professor of Cardiovascular Surgery at the University of Michigan, Ann Arbor, abstained from voting on whether the benefits of the system outweighed its risks. “I think there is potential benefit, but we don’t know which patients are most likely to have a benefit that outweighs any risks. More selective indications for this product could potentially tip the balance of the benefit outweighing the risks,” he said.
Robert Yeh, MD, director, Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, said he believed that the device was safe and effective and that its use resulted in a favorable risk-benefit ratio for patients. He pointed to the wide variability in effectiveness across the patient population and suggested that as the device becomes more widely used, experience will show which patients will benefit the most from its use.
Keith Allen, MD, director of surgical research at St. Luke’s Hospital of Kansas City, Kansas City, Mo., said the data presented by Medtronic reassured him that the device was safe, but he said he remained unconvinced that the device was effective. “I think that, while this is a safe procedure, the efficacy was mild at best, and that was only at 3 months,” he said.
Other panel members agreed.
“Yes as to safety, but no as to effectiveness,” said Mark Lockhart, MD, professor, department of radiology, University of Alabama, Birmingham. “There is too much uncertainty about there actually being a real benefit to outweigh even a small risk of an invasive procedure,” he said.
One of the statisticians on the panel, Benjamin Saville, PhD, director and senior statistical scientist, Berry Consultants, Austin, Texas, said he did not feel that effectiveness was adequately demonstrated in the trial data presented by Medtronic.
He agreed there is a small but potentially clinically meaningful benefit but voted no because he did not think benefit was demonstrated for those patients in the proposed indication. “For me, I think I would need additional randomized data to convince me that the benefits outweigh the risks.”
Julia Lewis, MD, professor of medicine at Vanderbilt University, Nashville, Tenn., voted against endorsing the device for efficacy. “We have one study that is negative and one that is minimally positive,” and there is no reason to think one of those results is more valid than the other, she said.
“So as far as I’m concerned, we still don’t know the efficacy of this, and if it gets on the market, the anecdotal, small sample size of each individual physician using this intervention will not allow them to select out the patients that will benefit from those who won’t benefit, and to not have a definitive study that better defines that it is efficacious and in whom is actually a disservice to the public,” she concluded.
After the panel meeting, Medtronic issued a statement on the result.
“We appreciate the robust conversation that occurred prior to the vote,” Jason Weidman, senior vice-president of the coronary and renal denervation business at Medtronic, said in the statement. “We will continue to collaborate with the FDA on bringing a new option to the millions of people living with high blood pressure.”
The lead investigator of the SPYRAL HTN-ON MED trial, David Kandzari, MD, chief at Piedmont Heart Institute and Cardiovascular Services, added, “The totality of the evidence demonstrated that there is a benefit with the SPYRAL RDN catheter, and there is no question about the safety of the procedure.”
A version of this article first appeared on Medscape.com.
The Food and Drug Administration’s Circulatory System Devices Panel unanimously agreed that the Symplicity Spyral Renal Denervation System (Medtronic) is safe, but the panel was split on its efficacy and whether the benefits outweighed the risks associated with its use.
The moderator’s tiebreaker vote went against the benefit-risk profile, for a final vote of 6 yes, 7 no, and 1 abstention.
The Symplicity Spyral system provides a catheter-based approach to denervate the renal arteries using radiofrequency energy. The proposed indication is for reduction of blood pressure in patients with uncontrolled hypertension despite their use of antihypertensive medications, or in patients who cannot tolerate antihypertensive medications.
The Spyral device received breakthrough device designation in March 2020. The FDA determined that the device met the criteria for inclusion in the program because it was a novel technology and had the potential to provide more effective treatment for patients with resistant or uncontrolled hypertension.
Medtronic presented data from two studies, the SPYRAL HTN-OFF and SPYRAL HTN-ON randomized trials.
HTN-OFF enrolled patients with hypertension whose medications could be discontinued at the start of the trial. The primary effectiveness endpoint was the mean difference in the baseline adjusted 24-hour ambulatory systolic blood pressure (ASBP) from baseline to 3 months post renal denervation or sham procedure. The study showed a statistically significant reduction of 3.9 mm Hg ASBP in patients who received the device compared with sham control patients.
HTN-ON evaluated patients with uncontrolled hypertension who continued taking their blood pressure medications during treatment with either the Spyral renal denervation device or a sham device. The primary endpoint was the mean difference in the baseline adjusted 24 hour ambulatory systolic blood pressure at 6 months. The study showed a nonsignificant 24-hour 0.03–mm Hg reduction in ambulatory systolic blood pressure in active-treatment patients compared with sham control patients.
Many on the panel agreed that the device was safe and effective. Randall Starling, MD, professor of medicine in the Heart, Vascular, and Thoracic Institute at Cleveland Clinic, said that he was comfortable with the data presented by Medtronic and that his affirmative vote reflected his recognition that hypertension is not effectively treated with current medications and that another tool in the armamentarium to treat patients is needed.
Matthew Corriere, MD, Frankel Professor of Cardiovascular Surgery at the University of Michigan, Ann Arbor, abstained from voting on whether the benefits of the system outweighed its risks. “I think there is potential benefit, but we don’t know which patients are most likely to have a benefit that outweighs any risks. More selective indications for this product could potentially tip the balance of the benefit outweighing the risks,” he said.
Robert Yeh, MD, director, Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, said he believed that the device was safe and effective and that its use resulted in a favorable risk-benefit ratio for patients. He pointed to the wide variability in effectiveness across the patient population and suggested that as the device becomes more widely used, experience will show which patients will benefit the most from its use.
Keith Allen, MD, director of surgical research at St. Luke’s Hospital of Kansas City, Kansas City, Mo., said the data presented by Medtronic reassured him that the device was safe, but he said he remained unconvinced that the device was effective. “I think that, while this is a safe procedure, the efficacy was mild at best, and that was only at 3 months,” he said.
Other panel members agreed.
“Yes as to safety, but no as to effectiveness,” said Mark Lockhart, MD, professor, department of radiology, University of Alabama, Birmingham. “There is too much uncertainty about there actually being a real benefit to outweigh even a small risk of an invasive procedure,” he said.
One of the statisticians on the panel, Benjamin Saville, PhD, director and senior statistical scientist, Berry Consultants, Austin, Texas, said he did not feel that effectiveness was adequately demonstrated in the trial data presented by Medtronic.
He agreed there is a small but potentially clinically meaningful benefit but voted no because he did not think benefit was demonstrated for those patients in the proposed indication. “For me, I think I would need additional randomized data to convince me that the benefits outweigh the risks.”
Julia Lewis, MD, professor of medicine at Vanderbilt University, Nashville, Tenn., voted against endorsing the device for efficacy. “We have one study that is negative and one that is minimally positive,” and there is no reason to think one of those results is more valid than the other, she said.
“So as far as I’m concerned, we still don’t know the efficacy of this, and if it gets on the market, the anecdotal, small sample size of each individual physician using this intervention will not allow them to select out the patients that will benefit from those who won’t benefit, and to not have a definitive study that better defines that it is efficacious and in whom is actually a disservice to the public,” she concluded.
After the panel meeting, Medtronic issued a statement on the result.
“We appreciate the robust conversation that occurred prior to the vote,” Jason Weidman, senior vice-president of the coronary and renal denervation business at Medtronic, said in the statement. “We will continue to collaborate with the FDA on bringing a new option to the millions of people living with high blood pressure.”
The lead investigator of the SPYRAL HTN-ON MED trial, David Kandzari, MD, chief at Piedmont Heart Institute and Cardiovascular Services, added, “The totality of the evidence demonstrated that there is a benefit with the SPYRAL RDN catheter, and there is no question about the safety of the procedure.”
A version of this article first appeared on Medscape.com.
The Food and Drug Administration’s Circulatory System Devices Panel unanimously agreed that the Symplicity Spyral Renal Denervation System (Medtronic) is safe, but the panel was split on its efficacy and whether the benefits outweighed the risks associated with its use.
The moderator’s tiebreaker vote went against the benefit-risk profile, for a final vote of 6 yes, 7 no, and 1 abstention.
The Symplicity Spyral system provides a catheter-based approach to denervate the renal arteries using radiofrequency energy. The proposed indication is for reduction of blood pressure in patients with uncontrolled hypertension despite their use of antihypertensive medications, or in patients who cannot tolerate antihypertensive medications.
The Spyral device received breakthrough device designation in March 2020. The FDA determined that the device met the criteria for inclusion in the program because it was a novel technology and had the potential to provide more effective treatment for patients with resistant or uncontrolled hypertension.
Medtronic presented data from two studies, the SPYRAL HTN-OFF and SPYRAL HTN-ON randomized trials.
HTN-OFF enrolled patients with hypertension whose medications could be discontinued at the start of the trial. The primary effectiveness endpoint was the mean difference in the baseline adjusted 24-hour ambulatory systolic blood pressure (ASBP) from baseline to 3 months post renal denervation or sham procedure. The study showed a statistically significant reduction of 3.9 mm Hg ASBP in patients who received the device compared with sham control patients.
HTN-ON evaluated patients with uncontrolled hypertension who continued taking their blood pressure medications during treatment with either the Spyral renal denervation device or a sham device. The primary endpoint was the mean difference in the baseline adjusted 24 hour ambulatory systolic blood pressure at 6 months. The study showed a nonsignificant 24-hour 0.03–mm Hg reduction in ambulatory systolic blood pressure in active-treatment patients compared with sham control patients.
Many on the panel agreed that the device was safe and effective. Randall Starling, MD, professor of medicine in the Heart, Vascular, and Thoracic Institute at Cleveland Clinic, said that he was comfortable with the data presented by Medtronic and that his affirmative vote reflected his recognition that hypertension is not effectively treated with current medications and that another tool in the armamentarium to treat patients is needed.
Matthew Corriere, MD, Frankel Professor of Cardiovascular Surgery at the University of Michigan, Ann Arbor, abstained from voting on whether the benefits of the system outweighed its risks. “I think there is potential benefit, but we don’t know which patients are most likely to have a benefit that outweighs any risks. More selective indications for this product could potentially tip the balance of the benefit outweighing the risks,” he said.
Robert Yeh, MD, director, Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, said he believed that the device was safe and effective and that its use resulted in a favorable risk-benefit ratio for patients. He pointed to the wide variability in effectiveness across the patient population and suggested that as the device becomes more widely used, experience will show which patients will benefit the most from its use.
Keith Allen, MD, director of surgical research at St. Luke’s Hospital of Kansas City, Kansas City, Mo., said the data presented by Medtronic reassured him that the device was safe, but he said he remained unconvinced that the device was effective. “I think that, while this is a safe procedure, the efficacy was mild at best, and that was only at 3 months,” he said.
Other panel members agreed.
“Yes as to safety, but no as to effectiveness,” said Mark Lockhart, MD, professor, department of radiology, University of Alabama, Birmingham. “There is too much uncertainty about there actually being a real benefit to outweigh even a small risk of an invasive procedure,” he said.
One of the statisticians on the panel, Benjamin Saville, PhD, director and senior statistical scientist, Berry Consultants, Austin, Texas, said he did not feel that effectiveness was adequately demonstrated in the trial data presented by Medtronic.
He agreed there is a small but potentially clinically meaningful benefit but voted no because he did not think benefit was demonstrated for those patients in the proposed indication. “For me, I think I would need additional randomized data to convince me that the benefits outweigh the risks.”
Julia Lewis, MD, professor of medicine at Vanderbilt University, Nashville, Tenn., voted against endorsing the device for efficacy. “We have one study that is negative and one that is minimally positive,” and there is no reason to think one of those results is more valid than the other, she said.
“So as far as I’m concerned, we still don’t know the efficacy of this, and if it gets on the market, the anecdotal, small sample size of each individual physician using this intervention will not allow them to select out the patients that will benefit from those who won’t benefit, and to not have a definitive study that better defines that it is efficacious and in whom is actually a disservice to the public,” she concluded.
After the panel meeting, Medtronic issued a statement on the result.
“We appreciate the robust conversation that occurred prior to the vote,” Jason Weidman, senior vice-president of the coronary and renal denervation business at Medtronic, said in the statement. “We will continue to collaborate with the FDA on bringing a new option to the millions of people living with high blood pressure.”
The lead investigator of the SPYRAL HTN-ON MED trial, David Kandzari, MD, chief at Piedmont Heart Institute and Cardiovascular Services, added, “The totality of the evidence demonstrated that there is a benefit with the SPYRAL RDN catheter, and there is no question about the safety of the procedure.”
A version of this article first appeared on Medscape.com.
ReCor renal denervation system safe, effective: FDA panel
in lowering blood pressure for adults with uncontrolled hypertension who may be inadequately responsive to, or who are intolerant of, antihypertensive medications.
The device is intended to be used in renal arteries with diameters of 3.0 to 8.0 mm.
After hearing data from three trials, RADIANCE-HTN SOLO, RADIANCE II, and RADIANCE-HTN TRIO, the 12-member panel unanimously agreed that there was “reasonable assurance” that the ReCor Paradise Ultrasound Renal Denervation System (ReCor Medical) was safe.
However, while most of the panel felt the device was effective, a few disagreed.
Keith Allen, MD, director of surgical research for the Mid-America Heart and Lung Surgeons, Kansas City, Mo., who was one of the three panel members who voted no regarding efficacy, stated that he had concerns about the duration and the degree of efficacy shown in the trials.
Mark Lockhart, MD, University of Alabama, Birmingham, also voted no. “I do think there was an effect for 2 months, but the duration of that positive effect appears to decline after that period of time.”
Benjamin Saville, PhD, echoed Dr. Lockhart’s concern: “The benefit is more short term, it is unclear what the long term benefit would be.”
Data from all three trials showed a significant drop in blood pressure with the device compared with pharmacologic therapy, but after 2 months of follow-up, that advantage disappeared.
The FDA highlighted data from the trials that showed that at 2 months, uRDN patients experienced significant reductions in systolic blood pressure compared with those treated with a sham device; however, by 6 months, there was a difference of only 1 mm Hg between the two groups.
“It seems when I look at 6 months and 12 months, the benefit is very tiny. We know the safety is fine, but a benefit of less than 1 mm Hg difference would not make me want to have an intervention,” said statistician Janet Wittes, PhD.
“I think the device is efficacious, even though there is not much difference between sham and treatment, but a big issue is the fact that half of our patients are not compliant. That will make the benefits over sham more clear,” noted Jim Blankenship, MD, professor of medicine and director of the division of cardiology at the University of New Mexico in Albuquerque.
John Hirshfeld Jr., MD, professor emeritus of medicine at the University of Pennsylvania, Philadelphia, said he voted yes on safety and efficacy but admitted he had some misgivings. “The sample size was small, but it is a novel tool to add to our tool box, and hopefully it will be used responsibly,” he said.
John Somberg, MD, professor emeritus of medicine, cardiology, and pharmacology, Rush University, Chicago, said the data on this procedure show “that antihypertensive medication works. Denervation is not superior to medications. It lowers blood pressure and is persistent, but when you can take the sham group to almost as good control as you get in the denervation group, that shows it can also be done with medicines.”
The panel wants to see results from additional studies in important subpopulations who are affected by hypertension, including Black people, women, the elderly, and people who already have cardiovascular risk factors, such as diabetes and heart failure.
Deneen Hesser, RN, the panel’s patient representative, called for any postmarketing studies that may be conducted by ReCor to include a good patient education program and also a way of documenting patient-reported outcomes.
“This would help us ascertain how happy people were if they were able to reduce their medication burden by, for example, one drug, or if they were willing to undergo a procedure to be able to stop taking so many antihypertensive medications,” she said.
The panel will meet again to review data on Medtronic’s Simplicity Spyral Renal Denervation System, which is also for patients with uncontrolled hypertension.
A version of this article appeared on Medscape.com.
in lowering blood pressure for adults with uncontrolled hypertension who may be inadequately responsive to, or who are intolerant of, antihypertensive medications.
The device is intended to be used in renal arteries with diameters of 3.0 to 8.0 mm.
After hearing data from three trials, RADIANCE-HTN SOLO, RADIANCE II, and RADIANCE-HTN TRIO, the 12-member panel unanimously agreed that there was “reasonable assurance” that the ReCor Paradise Ultrasound Renal Denervation System (ReCor Medical) was safe.
However, while most of the panel felt the device was effective, a few disagreed.
Keith Allen, MD, director of surgical research for the Mid-America Heart and Lung Surgeons, Kansas City, Mo., who was one of the three panel members who voted no regarding efficacy, stated that he had concerns about the duration and the degree of efficacy shown in the trials.
Mark Lockhart, MD, University of Alabama, Birmingham, also voted no. “I do think there was an effect for 2 months, but the duration of that positive effect appears to decline after that period of time.”
Benjamin Saville, PhD, echoed Dr. Lockhart’s concern: “The benefit is more short term, it is unclear what the long term benefit would be.”
Data from all three trials showed a significant drop in blood pressure with the device compared with pharmacologic therapy, but after 2 months of follow-up, that advantage disappeared.
The FDA highlighted data from the trials that showed that at 2 months, uRDN patients experienced significant reductions in systolic blood pressure compared with those treated with a sham device; however, by 6 months, there was a difference of only 1 mm Hg between the two groups.
“It seems when I look at 6 months and 12 months, the benefit is very tiny. We know the safety is fine, but a benefit of less than 1 mm Hg difference would not make me want to have an intervention,” said statistician Janet Wittes, PhD.
“I think the device is efficacious, even though there is not much difference between sham and treatment, but a big issue is the fact that half of our patients are not compliant. That will make the benefits over sham more clear,” noted Jim Blankenship, MD, professor of medicine and director of the division of cardiology at the University of New Mexico in Albuquerque.
John Hirshfeld Jr., MD, professor emeritus of medicine at the University of Pennsylvania, Philadelphia, said he voted yes on safety and efficacy but admitted he had some misgivings. “The sample size was small, but it is a novel tool to add to our tool box, and hopefully it will be used responsibly,” he said.
John Somberg, MD, professor emeritus of medicine, cardiology, and pharmacology, Rush University, Chicago, said the data on this procedure show “that antihypertensive medication works. Denervation is not superior to medications. It lowers blood pressure and is persistent, but when you can take the sham group to almost as good control as you get in the denervation group, that shows it can also be done with medicines.”
The panel wants to see results from additional studies in important subpopulations who are affected by hypertension, including Black people, women, the elderly, and people who already have cardiovascular risk factors, such as diabetes and heart failure.
Deneen Hesser, RN, the panel’s patient representative, called for any postmarketing studies that may be conducted by ReCor to include a good patient education program and also a way of documenting patient-reported outcomes.
“This would help us ascertain how happy people were if they were able to reduce their medication burden by, for example, one drug, or if they were willing to undergo a procedure to be able to stop taking so many antihypertensive medications,” she said.
The panel will meet again to review data on Medtronic’s Simplicity Spyral Renal Denervation System, which is also for patients with uncontrolled hypertension.
A version of this article appeared on Medscape.com.
in lowering blood pressure for adults with uncontrolled hypertension who may be inadequately responsive to, or who are intolerant of, antihypertensive medications.
The device is intended to be used in renal arteries with diameters of 3.0 to 8.0 mm.
After hearing data from three trials, RADIANCE-HTN SOLO, RADIANCE II, and RADIANCE-HTN TRIO, the 12-member panel unanimously agreed that there was “reasonable assurance” that the ReCor Paradise Ultrasound Renal Denervation System (ReCor Medical) was safe.
However, while most of the panel felt the device was effective, a few disagreed.
Keith Allen, MD, director of surgical research for the Mid-America Heart and Lung Surgeons, Kansas City, Mo., who was one of the three panel members who voted no regarding efficacy, stated that he had concerns about the duration and the degree of efficacy shown in the trials.
Mark Lockhart, MD, University of Alabama, Birmingham, also voted no. “I do think there was an effect for 2 months, but the duration of that positive effect appears to decline after that period of time.”
Benjamin Saville, PhD, echoed Dr. Lockhart’s concern: “The benefit is more short term, it is unclear what the long term benefit would be.”
Data from all three trials showed a significant drop in blood pressure with the device compared with pharmacologic therapy, but after 2 months of follow-up, that advantage disappeared.
The FDA highlighted data from the trials that showed that at 2 months, uRDN patients experienced significant reductions in systolic blood pressure compared with those treated with a sham device; however, by 6 months, there was a difference of only 1 mm Hg between the two groups.
“It seems when I look at 6 months and 12 months, the benefit is very tiny. We know the safety is fine, but a benefit of less than 1 mm Hg difference would not make me want to have an intervention,” said statistician Janet Wittes, PhD.
“I think the device is efficacious, even though there is not much difference between sham and treatment, but a big issue is the fact that half of our patients are not compliant. That will make the benefits over sham more clear,” noted Jim Blankenship, MD, professor of medicine and director of the division of cardiology at the University of New Mexico in Albuquerque.
John Hirshfeld Jr., MD, professor emeritus of medicine at the University of Pennsylvania, Philadelphia, said he voted yes on safety and efficacy but admitted he had some misgivings. “The sample size was small, but it is a novel tool to add to our tool box, and hopefully it will be used responsibly,” he said.
John Somberg, MD, professor emeritus of medicine, cardiology, and pharmacology, Rush University, Chicago, said the data on this procedure show “that antihypertensive medication works. Denervation is not superior to medications. It lowers blood pressure and is persistent, but when you can take the sham group to almost as good control as you get in the denervation group, that shows it can also be done with medicines.”
The panel wants to see results from additional studies in important subpopulations who are affected by hypertension, including Black people, women, the elderly, and people who already have cardiovascular risk factors, such as diabetes and heart failure.
Deneen Hesser, RN, the panel’s patient representative, called for any postmarketing studies that may be conducted by ReCor to include a good patient education program and also a way of documenting patient-reported outcomes.
“This would help us ascertain how happy people were if they were able to reduce their medication burden by, for example, one drug, or if they were willing to undergo a procedure to be able to stop taking so many antihypertensive medications,” she said.
The panel will meet again to review data on Medtronic’s Simplicity Spyral Renal Denervation System, which is also for patients with uncontrolled hypertension.
A version of this article appeared on Medscape.com.
Revised presentation of obesity may reduce internalized bias
a new study suggests.
In an online study, patients with obesity reported significantly less internalized weight bias and significantly enhanced perceptions of positive communication with their medical providers after watching a video of a doctor who framed obesity as a treatable medical condition, compared with a video of a doctor who emphasized willpower.
“Recent research has identified the dominant role that biology (both genetics as well as homeostatic, hedonic, and executive brain systems) and environment, rather than willpower, play in the development of obesity and the resistance to weight loss,” wrote study authors Sara English, a medical student, and Michael Vallis, MD, associate professor of family medicine, both at Dalhousie University, Halifax, N.S. “Yet the false narrative that ideal or goal weight can be achieved by eating less and moving more using willpower continues to dominate the public narrative.”
The findings were published in Clinical Obesity.
Medical complexity
The public discussion generally places all responsibility for the health outcomes of obesity on the patient. As a result, patients with obesity face bias and stigma from the public and the health care system, wrote the authors.
This stigmatization contributes to increased mortality and morbidity by promoting maladaptive eating behaviors and stress. It also causes mistrust of health care professionals, which, in turn, leads to worse health outcomes and increased health care costs.
The 2020 Canadian clinical practice guidelines for obesity management in adults emphasize that obesity is complex and that nonbehavioral factors strongly influence it. They recommend that treatment focus on improving patient-centered health outcomes and address the root causes of obesity, instead of focusing on weight loss alone.
In the present study, Ms. English and Dr. Vallis evaluated how presenting obesity as a treatable medical condition affected participants’ internalized weight bias and their perceived relationship with their health care provider. They asked 61 patients with obesity (average age, 49 years; average body mass index, 41 kg/m2) to watch two videos, the first showing a doctor endorsing the traditional “eat less, move more approach,” and the second showing a doctor describing obesity as a chronic, treatable medical condition.
Nearly half (49.5%) of participants reported that their health care provider rarely or never discusses weight loss, and almost two-thirds of participants (64%) reported feeling stigmatized by their health care provider because of their weight at least some of the time.
After having watched each video, participants were asked to imagine that they were being treated by the corresponding doctor and to complete two measures: the Weight Bias Internalization Scale (WBIS), which measures the degree to which a respondent believes the negative stereotypes about obese people, and the Patient-Health Care Provider Communication Scale (PHCPCS), which assesses the quality of patient–health care provider communication.
Virtually all participants preferred the care provider in the video with the revised presentation of obesity. Only one preferred the traditional video. The video with the revised presentation was associated with significant reductions in internalized weight bias. Participants’ WBIS total score decreased from 4.49 to 3.36 (P < .001). The revised narrative video also had a positive effect on patients’ perception of their health care providers. The PHCPCS total score increased from 2.65 to 4.20 (P < .001).
A chronic disease
In a comment, Yoni Freedhoff, MD, associate professor of family medicine at the University of Ottawa, said: “If you’re asking me if it is a good idea to treat obesity like a chronic disease, the answer would be yes, we absolutely should. It is a chronic disease, and it shouldn’t have a treatment paradigm different from the other chronic diseases.” Dr. Freedhoff did not participate in the study.
“We certainly don’t blame patients for having other chronic conditions,” Dr. Freedhoff added. “We don’t have a narrative that, in order for them to qualify for medication or other treatment options, they have to audition for them by failing lifestyle approaches first. And yet, I’d say at least 85% of chronic noncommunicable diseases have lifestyle factors, but obesity is the only one where we consider that there is a necessity for these lifestyle changes, as if there have been studies demonstrating durable and reproducible outcomes for lifestyle in obesity. There have not.”
Telling patients and doctors that obesity is a chronic disease driven by biology, not a failure of willpower, is going to reduce stigma, “which is what this study was able to demonstrate to some degree,” Dr. Freedhoff said.
“What is more stigmatizing? Being told that if you just try hard enough, you’ll succeed, and if you don’t succeed, the corollary, of course, is that you did not try hard enough? Versus, you’ve got a medical condition where you’ve got biological drivers beyond your locus of control, affecting behaviors that, in turn, contribute to your adiposity? I’m pretty sure the second statement will have far less impact on a person’s internalized weight bias than what we’ve unfortunately been doing up until now with the focus on willpower,” Dr. Freedhoff said.
No funding for the study was reported. Ms. English and Dr. Vallis reported no relevant financial relationships. Dr. Freedhoff reported receiving clinical grants from Novo Nordisk.
A version of this article first appeared on Medscape.com.
a new study suggests.
In an online study, patients with obesity reported significantly less internalized weight bias and significantly enhanced perceptions of positive communication with their medical providers after watching a video of a doctor who framed obesity as a treatable medical condition, compared with a video of a doctor who emphasized willpower.
“Recent research has identified the dominant role that biology (both genetics as well as homeostatic, hedonic, and executive brain systems) and environment, rather than willpower, play in the development of obesity and the resistance to weight loss,” wrote study authors Sara English, a medical student, and Michael Vallis, MD, associate professor of family medicine, both at Dalhousie University, Halifax, N.S. “Yet the false narrative that ideal or goal weight can be achieved by eating less and moving more using willpower continues to dominate the public narrative.”
The findings were published in Clinical Obesity.
Medical complexity
The public discussion generally places all responsibility for the health outcomes of obesity on the patient. As a result, patients with obesity face bias and stigma from the public and the health care system, wrote the authors.
This stigmatization contributes to increased mortality and morbidity by promoting maladaptive eating behaviors and stress. It also causes mistrust of health care professionals, which, in turn, leads to worse health outcomes and increased health care costs.
The 2020 Canadian clinical practice guidelines for obesity management in adults emphasize that obesity is complex and that nonbehavioral factors strongly influence it. They recommend that treatment focus on improving patient-centered health outcomes and address the root causes of obesity, instead of focusing on weight loss alone.
In the present study, Ms. English and Dr. Vallis evaluated how presenting obesity as a treatable medical condition affected participants’ internalized weight bias and their perceived relationship with their health care provider. They asked 61 patients with obesity (average age, 49 years; average body mass index, 41 kg/m2) to watch two videos, the first showing a doctor endorsing the traditional “eat less, move more approach,” and the second showing a doctor describing obesity as a chronic, treatable medical condition.
Nearly half (49.5%) of participants reported that their health care provider rarely or never discusses weight loss, and almost two-thirds of participants (64%) reported feeling stigmatized by their health care provider because of their weight at least some of the time.
After having watched each video, participants were asked to imagine that they were being treated by the corresponding doctor and to complete two measures: the Weight Bias Internalization Scale (WBIS), which measures the degree to which a respondent believes the negative stereotypes about obese people, and the Patient-Health Care Provider Communication Scale (PHCPCS), which assesses the quality of patient–health care provider communication.
Virtually all participants preferred the care provider in the video with the revised presentation of obesity. Only one preferred the traditional video. The video with the revised presentation was associated with significant reductions in internalized weight bias. Participants’ WBIS total score decreased from 4.49 to 3.36 (P < .001). The revised narrative video also had a positive effect on patients’ perception of their health care providers. The PHCPCS total score increased from 2.65 to 4.20 (P < .001).
A chronic disease
In a comment, Yoni Freedhoff, MD, associate professor of family medicine at the University of Ottawa, said: “If you’re asking me if it is a good idea to treat obesity like a chronic disease, the answer would be yes, we absolutely should. It is a chronic disease, and it shouldn’t have a treatment paradigm different from the other chronic diseases.” Dr. Freedhoff did not participate in the study.
“We certainly don’t blame patients for having other chronic conditions,” Dr. Freedhoff added. “We don’t have a narrative that, in order for them to qualify for medication or other treatment options, they have to audition for them by failing lifestyle approaches first. And yet, I’d say at least 85% of chronic noncommunicable diseases have lifestyle factors, but obesity is the only one where we consider that there is a necessity for these lifestyle changes, as if there have been studies demonstrating durable and reproducible outcomes for lifestyle in obesity. There have not.”
Telling patients and doctors that obesity is a chronic disease driven by biology, not a failure of willpower, is going to reduce stigma, “which is what this study was able to demonstrate to some degree,” Dr. Freedhoff said.
“What is more stigmatizing? Being told that if you just try hard enough, you’ll succeed, and if you don’t succeed, the corollary, of course, is that you did not try hard enough? Versus, you’ve got a medical condition where you’ve got biological drivers beyond your locus of control, affecting behaviors that, in turn, contribute to your adiposity? I’m pretty sure the second statement will have far less impact on a person’s internalized weight bias than what we’ve unfortunately been doing up until now with the focus on willpower,” Dr. Freedhoff said.
No funding for the study was reported. Ms. English and Dr. Vallis reported no relevant financial relationships. Dr. Freedhoff reported receiving clinical grants from Novo Nordisk.
A version of this article first appeared on Medscape.com.
a new study suggests.
In an online study, patients with obesity reported significantly less internalized weight bias and significantly enhanced perceptions of positive communication with their medical providers after watching a video of a doctor who framed obesity as a treatable medical condition, compared with a video of a doctor who emphasized willpower.
“Recent research has identified the dominant role that biology (both genetics as well as homeostatic, hedonic, and executive brain systems) and environment, rather than willpower, play in the development of obesity and the resistance to weight loss,” wrote study authors Sara English, a medical student, and Michael Vallis, MD, associate professor of family medicine, both at Dalhousie University, Halifax, N.S. “Yet the false narrative that ideal or goal weight can be achieved by eating less and moving more using willpower continues to dominate the public narrative.”
The findings were published in Clinical Obesity.
Medical complexity
The public discussion generally places all responsibility for the health outcomes of obesity on the patient. As a result, patients with obesity face bias and stigma from the public and the health care system, wrote the authors.
This stigmatization contributes to increased mortality and morbidity by promoting maladaptive eating behaviors and stress. It also causes mistrust of health care professionals, which, in turn, leads to worse health outcomes and increased health care costs.
The 2020 Canadian clinical practice guidelines for obesity management in adults emphasize that obesity is complex and that nonbehavioral factors strongly influence it. They recommend that treatment focus on improving patient-centered health outcomes and address the root causes of obesity, instead of focusing on weight loss alone.
In the present study, Ms. English and Dr. Vallis evaluated how presenting obesity as a treatable medical condition affected participants’ internalized weight bias and their perceived relationship with their health care provider. They asked 61 patients with obesity (average age, 49 years; average body mass index, 41 kg/m2) to watch two videos, the first showing a doctor endorsing the traditional “eat less, move more approach,” and the second showing a doctor describing obesity as a chronic, treatable medical condition.
Nearly half (49.5%) of participants reported that their health care provider rarely or never discusses weight loss, and almost two-thirds of participants (64%) reported feeling stigmatized by their health care provider because of their weight at least some of the time.
After having watched each video, participants were asked to imagine that they were being treated by the corresponding doctor and to complete two measures: the Weight Bias Internalization Scale (WBIS), which measures the degree to which a respondent believes the negative stereotypes about obese people, and the Patient-Health Care Provider Communication Scale (PHCPCS), which assesses the quality of patient–health care provider communication.
Virtually all participants preferred the care provider in the video with the revised presentation of obesity. Only one preferred the traditional video. The video with the revised presentation was associated with significant reductions in internalized weight bias. Participants’ WBIS total score decreased from 4.49 to 3.36 (P < .001). The revised narrative video also had a positive effect on patients’ perception of their health care providers. The PHCPCS total score increased from 2.65 to 4.20 (P < .001).
A chronic disease
In a comment, Yoni Freedhoff, MD, associate professor of family medicine at the University of Ottawa, said: “If you’re asking me if it is a good idea to treat obesity like a chronic disease, the answer would be yes, we absolutely should. It is a chronic disease, and it shouldn’t have a treatment paradigm different from the other chronic diseases.” Dr. Freedhoff did not participate in the study.
“We certainly don’t blame patients for having other chronic conditions,” Dr. Freedhoff added. “We don’t have a narrative that, in order for them to qualify for medication or other treatment options, they have to audition for them by failing lifestyle approaches first. And yet, I’d say at least 85% of chronic noncommunicable diseases have lifestyle factors, but obesity is the only one where we consider that there is a necessity for these lifestyle changes, as if there have been studies demonstrating durable and reproducible outcomes for lifestyle in obesity. There have not.”
Telling patients and doctors that obesity is a chronic disease driven by biology, not a failure of willpower, is going to reduce stigma, “which is what this study was able to demonstrate to some degree,” Dr. Freedhoff said.
“What is more stigmatizing? Being told that if you just try hard enough, you’ll succeed, and if you don’t succeed, the corollary, of course, is that you did not try hard enough? Versus, you’ve got a medical condition where you’ve got biological drivers beyond your locus of control, affecting behaviors that, in turn, contribute to your adiposity? I’m pretty sure the second statement will have far less impact on a person’s internalized weight bias than what we’ve unfortunately been doing up until now with the focus on willpower,” Dr. Freedhoff said.
No funding for the study was reported. Ms. English and Dr. Vallis reported no relevant financial relationships. Dr. Freedhoff reported receiving clinical grants from Novo Nordisk.
A version of this article first appeared on Medscape.com.
FROM CLINICAL OBESITY
Obesity cardiomyopathy tied to sudden cardiac death
a new case-control study suggests.
Researchers who analyzed hearts taken at autopsy from people who had died from sudden cardiac death found that a number of the hearts obtained from obese decedents were heavier than those from normal-weight decedents and that the hazard ratio of unexplained cardiomegaly in this cohort was 5.3, compared with normal-weight individuals.
“Even when we ruled out any conditions that could potentially cause enlargement of the heart, including hypertension, heart valve problems, diabetes, and other cardiovascular risk factors, the association with obesity cardiomyopathy, or OCM, and sudden cardiac death remained,” lead author Joseph Westaby, PhD, from the Cardiac Risk in the Young (CRY) Cardiovascular Pathology Laboratories at St George’s University of London, said in an interview.
The study was published online in JACC: Advances.
Intrigued by this finding, Dr. Westaby and associates sought to characterize the clinical and pathological features of OCM associated with sudden cardiac death by comparing this population to two control groups: sudden cardiac death patients who were either obese or of normal weight, and had morphologically normal hearts.
Their group is uniquely positioned to do such research, Dr. Westaby explained.
“Here at St George’s University of London, we have a specialized cardiovascular pathology service. ... All hearts obtained at autopsy from individuals who have died from sudden cardiac death, or who were suspected to have had a cardiovascular cause of death, anywhere in the U.K., are referred to the CRY Centre for further analysis,” he said.
Patients were divided into two groups according to body mass index: an obesity group (BMI > 30 kg/m2) and a normal-weight group (BMI, 18.5-24.9).
An increased heart weight above 550 g in men and 450 g in women in the absence of coronary artery disease, hypertension, diabetes, or valvular disease was classified as unexplained cardiomegaly, and individuals with obesity and cardiomegaly were defined as obesity cardiomyopathy.
Age- and sex-matched controls with obesity (n = 106) were selected based on a BMI greater than 30, with a morphologically normal heart weighing less than 550 g in men and than 450 g in women.
Age- and sex-matched normal weight controls (n = 106) were selected based on a BMI of 18.5-24.9 and a morphologically normal heart weighing less than 550 g in men and less than 450 g in women.
The researchers identified 53 OCM cases from a cohort of more than 4,500 sudden cardiac death cases that had BMI measurements. In normal-weight patients, there were 14 cases of unexplained cardiomegaly.
The mean age at death of individuals with OCM was 42 years (range, 30-54 years). Most of the deaths occurred in men (n = 34; 64%), who also died younger than women (40 ± 13 years vs. 45 ± 10 years; P = .036).
The average heart weight in OCM patients was 598 ± 93 g. Risk of sudden cardiac death increased when BMI reached 35.
Compared with matched controls, there were increases in right and left ventricular wall thickness (all P < .05) in OCM cases. Right ventricular epicardial fat was increased in OCM cases, compared with normal-weight controls only.
Left ventricular fibrosis was identified in seven (13%) OCM cases.
Role of genetics to be explored
“This study highlights the need for further investigation into these individuals because, at the moment, we can’t be sure that the only contributing factor to this is the obesity,” said Dr. Westaby.
In the works are plans to see if there may be an underlying genetic predisposition in obese individuals that may have contributed to the development of an enlarged heart. The group also plans to study the families of the deceased individuals to determine if they are at risk of developing cardiomegaly, he said.
“This paper makes an important contribution to the literature that raises many important questions for future research,” Timothy P. Fitzgibbons, MD, PhD, from the University of Massachusetts, Worcester, wrote in an accompanying editorial.
Being able to access so many autopsy samples gives the current study considerable heft, Dr. Fitzgibbons said in an interview.
“A lot has been made of the obesity paradox and the perhaps benign nature of obesity but this paper suggests the opposite, that it is a very serious problem and can, in fact, in and of itself, cause heart abnormalities that could cause sudden death,” he noted.
The fact that only 13% of OCM cases had fibrosis on histology suggests that fibrosis was not the main cause of sudden cardiac death, he said.
“Often we will do MRIs to look for areas of fibrosis within the heart because those areas make patients prone to re-entry arrhythmias, in particular, ventricular tachycardia. But the authors suggest that the enlarged myocytes may themselves be predisposing to arrhythmias, rather than fibrosis,” Dr. Fitzgibbons said.
The study was supported by Cardiac Risk in the Young. Dr. Westaby and Dr. Fitzgibbons have reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
a new case-control study suggests.
Researchers who analyzed hearts taken at autopsy from people who had died from sudden cardiac death found that a number of the hearts obtained from obese decedents were heavier than those from normal-weight decedents and that the hazard ratio of unexplained cardiomegaly in this cohort was 5.3, compared with normal-weight individuals.
“Even when we ruled out any conditions that could potentially cause enlargement of the heart, including hypertension, heart valve problems, diabetes, and other cardiovascular risk factors, the association with obesity cardiomyopathy, or OCM, and sudden cardiac death remained,” lead author Joseph Westaby, PhD, from the Cardiac Risk in the Young (CRY) Cardiovascular Pathology Laboratories at St George’s University of London, said in an interview.
The study was published online in JACC: Advances.
Intrigued by this finding, Dr. Westaby and associates sought to characterize the clinical and pathological features of OCM associated with sudden cardiac death by comparing this population to two control groups: sudden cardiac death patients who were either obese or of normal weight, and had morphologically normal hearts.
Their group is uniquely positioned to do such research, Dr. Westaby explained.
“Here at St George’s University of London, we have a specialized cardiovascular pathology service. ... All hearts obtained at autopsy from individuals who have died from sudden cardiac death, or who were suspected to have had a cardiovascular cause of death, anywhere in the U.K., are referred to the CRY Centre for further analysis,” he said.
Patients were divided into two groups according to body mass index: an obesity group (BMI > 30 kg/m2) and a normal-weight group (BMI, 18.5-24.9).
An increased heart weight above 550 g in men and 450 g in women in the absence of coronary artery disease, hypertension, diabetes, or valvular disease was classified as unexplained cardiomegaly, and individuals with obesity and cardiomegaly were defined as obesity cardiomyopathy.
Age- and sex-matched controls with obesity (n = 106) were selected based on a BMI greater than 30, with a morphologically normal heart weighing less than 550 g in men and than 450 g in women.
Age- and sex-matched normal weight controls (n = 106) were selected based on a BMI of 18.5-24.9 and a morphologically normal heart weighing less than 550 g in men and less than 450 g in women.
The researchers identified 53 OCM cases from a cohort of more than 4,500 sudden cardiac death cases that had BMI measurements. In normal-weight patients, there were 14 cases of unexplained cardiomegaly.
The mean age at death of individuals with OCM was 42 years (range, 30-54 years). Most of the deaths occurred in men (n = 34; 64%), who also died younger than women (40 ± 13 years vs. 45 ± 10 years; P = .036).
The average heart weight in OCM patients was 598 ± 93 g. Risk of sudden cardiac death increased when BMI reached 35.
Compared with matched controls, there were increases in right and left ventricular wall thickness (all P < .05) in OCM cases. Right ventricular epicardial fat was increased in OCM cases, compared with normal-weight controls only.
Left ventricular fibrosis was identified in seven (13%) OCM cases.
Role of genetics to be explored
“This study highlights the need for further investigation into these individuals because, at the moment, we can’t be sure that the only contributing factor to this is the obesity,” said Dr. Westaby.
In the works are plans to see if there may be an underlying genetic predisposition in obese individuals that may have contributed to the development of an enlarged heart. The group also plans to study the families of the deceased individuals to determine if they are at risk of developing cardiomegaly, he said.
“This paper makes an important contribution to the literature that raises many important questions for future research,” Timothy P. Fitzgibbons, MD, PhD, from the University of Massachusetts, Worcester, wrote in an accompanying editorial.
Being able to access so many autopsy samples gives the current study considerable heft, Dr. Fitzgibbons said in an interview.
“A lot has been made of the obesity paradox and the perhaps benign nature of obesity but this paper suggests the opposite, that it is a very serious problem and can, in fact, in and of itself, cause heart abnormalities that could cause sudden death,” he noted.
The fact that only 13% of OCM cases had fibrosis on histology suggests that fibrosis was not the main cause of sudden cardiac death, he said.
“Often we will do MRIs to look for areas of fibrosis within the heart because those areas make patients prone to re-entry arrhythmias, in particular, ventricular tachycardia. But the authors suggest that the enlarged myocytes may themselves be predisposing to arrhythmias, rather than fibrosis,” Dr. Fitzgibbons said.
The study was supported by Cardiac Risk in the Young. Dr. Westaby and Dr. Fitzgibbons have reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
a new case-control study suggests.
Researchers who analyzed hearts taken at autopsy from people who had died from sudden cardiac death found that a number of the hearts obtained from obese decedents were heavier than those from normal-weight decedents and that the hazard ratio of unexplained cardiomegaly in this cohort was 5.3, compared with normal-weight individuals.
“Even when we ruled out any conditions that could potentially cause enlargement of the heart, including hypertension, heart valve problems, diabetes, and other cardiovascular risk factors, the association with obesity cardiomyopathy, or OCM, and sudden cardiac death remained,” lead author Joseph Westaby, PhD, from the Cardiac Risk in the Young (CRY) Cardiovascular Pathology Laboratories at St George’s University of London, said in an interview.
The study was published online in JACC: Advances.
Intrigued by this finding, Dr. Westaby and associates sought to characterize the clinical and pathological features of OCM associated with sudden cardiac death by comparing this population to two control groups: sudden cardiac death patients who were either obese or of normal weight, and had morphologically normal hearts.
Their group is uniquely positioned to do such research, Dr. Westaby explained.
“Here at St George’s University of London, we have a specialized cardiovascular pathology service. ... All hearts obtained at autopsy from individuals who have died from sudden cardiac death, or who were suspected to have had a cardiovascular cause of death, anywhere in the U.K., are referred to the CRY Centre for further analysis,” he said.
Patients were divided into two groups according to body mass index: an obesity group (BMI > 30 kg/m2) and a normal-weight group (BMI, 18.5-24.9).
An increased heart weight above 550 g in men and 450 g in women in the absence of coronary artery disease, hypertension, diabetes, or valvular disease was classified as unexplained cardiomegaly, and individuals with obesity and cardiomegaly were defined as obesity cardiomyopathy.
Age- and sex-matched controls with obesity (n = 106) were selected based on a BMI greater than 30, with a morphologically normal heart weighing less than 550 g in men and than 450 g in women.
Age- and sex-matched normal weight controls (n = 106) were selected based on a BMI of 18.5-24.9 and a morphologically normal heart weighing less than 550 g in men and less than 450 g in women.
The researchers identified 53 OCM cases from a cohort of more than 4,500 sudden cardiac death cases that had BMI measurements. In normal-weight patients, there were 14 cases of unexplained cardiomegaly.
The mean age at death of individuals with OCM was 42 years (range, 30-54 years). Most of the deaths occurred in men (n = 34; 64%), who also died younger than women (40 ± 13 years vs. 45 ± 10 years; P = .036).
The average heart weight in OCM patients was 598 ± 93 g. Risk of sudden cardiac death increased when BMI reached 35.
Compared with matched controls, there were increases in right and left ventricular wall thickness (all P < .05) in OCM cases. Right ventricular epicardial fat was increased in OCM cases, compared with normal-weight controls only.
Left ventricular fibrosis was identified in seven (13%) OCM cases.
Role of genetics to be explored
“This study highlights the need for further investigation into these individuals because, at the moment, we can’t be sure that the only contributing factor to this is the obesity,” said Dr. Westaby.
In the works are plans to see if there may be an underlying genetic predisposition in obese individuals that may have contributed to the development of an enlarged heart. The group also plans to study the families of the deceased individuals to determine if they are at risk of developing cardiomegaly, he said.
“This paper makes an important contribution to the literature that raises many important questions for future research,” Timothy P. Fitzgibbons, MD, PhD, from the University of Massachusetts, Worcester, wrote in an accompanying editorial.
Being able to access so many autopsy samples gives the current study considerable heft, Dr. Fitzgibbons said in an interview.
“A lot has been made of the obesity paradox and the perhaps benign nature of obesity but this paper suggests the opposite, that it is a very serious problem and can, in fact, in and of itself, cause heart abnormalities that could cause sudden death,” he noted.
The fact that only 13% of OCM cases had fibrosis on histology suggests that fibrosis was not the main cause of sudden cardiac death, he said.
“Often we will do MRIs to look for areas of fibrosis within the heart because those areas make patients prone to re-entry arrhythmias, in particular, ventricular tachycardia. But the authors suggest that the enlarged myocytes may themselves be predisposing to arrhythmias, rather than fibrosis,” Dr. Fitzgibbons said.
The study was supported by Cardiac Risk in the Young. Dr. Westaby and Dr. Fitzgibbons have reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM JACC: ADVANCES
Statins post PCI: Moderate intensity plus ezetimibe may be preferable
, suggests a “real-world” cohort study that is consistent with trial evidence.
In the observational study with more than 273,000 patients who received percutaneous coronary intervention (PCI) with drug-eluting stents (DES), risk for a broad composite clinical primary endpoint fell by one-fourth (P < .001) among those put on the two-drug regimen with a moderate-intensity statin, compared with those getting a high-intensity statin alone.
The dual-agent approach was also associated with a 15% drop in statin discontinuation and a 20% reduced risk for new-onset diabetes requiring medication (P < .001 for both benefits), reported investigators in the Journal of the American College of Cardiology.
The study’s primary endpoint – a composite of cardiovascular (CV) death, myocardial infarction (MI), coronary revascularization, heart failure (HF) hospitalization, or nonfatal stroke at 3 years – replicated that of the randomized RACING trial conducted by many of the same researchers and published about a year ago in The Lancet.
RACING demonstrated that ezetimibe plus a moderate-intensity statin could be as effective as a high-intensity statin in patients with CV disease, “but have fewer side effects and better compliance,” Myeong-Ki Hong, MD, PhD, Severance Hospital, Yonsei University, Seoul, South Korea, said in an interview.
Dr. Hong is senior author on the current observational study based on the CONNECT-DES registry, which compared rosuvastatin 10 mg/day plus ezetimibe 10 mg/day – used in RACING – with rosuvastatin 20 mg/day in a nationwide cohort of 72,050 patients.
“As we know, populations who are enrolled in randomized studies do not sufficiently represent real patients in practice,” he observed, “so we wanted to evaluate the generalizability of the RACING results in daily clinical practice.”
Deepak L. Bhatt, MD, said he likes studies that look at whether clinical trial results “play out in the real world,” as this one did. “They have largely replicated the results of the RACING trial,” suggesting the approach using a moderate-intensity statin “is the way to go,” Dr. Bhatt of Mount Sinai Health System, New York, who was not affiliated with the current report, said in an interview. “In fact, the moderate-intensity combination regimen was actually better in this study.”
He said the observed reduction in new-onset diabetes with the moderate-intensity statin approach is also important. “There is a link between high-dose statins and diabetes. So, if given the choice, if you can get the benefits from a cardiovascular perspective with a lower risk of diabetes, it makes sense to use the combination therapy.”
Dr. Bhatt said he had been using high-intensity statin monotherapy in his high-risk patients, but RACING made him reconsider the value of moderate-dose statin combination therapy. “Going with lower doses of two drugs instead of high doses of one drug minimizes side effects and, in some cases, can even enhance efficacy – so this is not an unreasonable paradigm.”
In the current cohort study of patients prescribed rosuvastatin after DES implantation, 10,794 received rosuvastatin 10 mg/day plus ezetimibe 10 mg/day, and 61,256 were put on rosuvastatin 20 mg/day.
Hazard ratio risk reductions with the dual-agent lipid-lowering therapy approach, compared with high-intensity statin monotherapy, were more favorable for the primary composite clinical endpoint and important secondary events:
- HR, 0.75; 95% confidence interval, 0.70-0.79; P < .001) for CV death, MI, coronary artery revascularization, HF, or stroke at 3 years.
- HR, 0.85; 95% CI, 0.78-0.94; P = .001) for statin discontinuation.
- HR, 0.80; 95% CI, 0.72-0.88; P < .001) for new-onset diabetes requiring medication.
But HRs for rhabdomyolysis, cholecystectomy, or a new cancer diagnosis did not indicate significant differences between the two groups.
“Now that there is evidence to support the favorable clinical outcomes of combination lipid-lowering therapy with moderate-intensity statin plus ezetimibe” for secondary prevention from both RACING and a study reflecting daily clinical practice, Dr. Hong said, “physicians may feel more comfortable with this approach.”
The registry analysis “is remarkable not only for validating the results of the RACING trial in routine clinical practice in a high-risk secondary prevention population, but also for its innovative methodology,” states an accompanying editorial by Ori Ben-Yehuda, MD, Sulpizio Cardiovascular Center, University of California, San Diego.
Use of such a large single-payer database in their study “affords even greater external validity to the findings, complementing the internal validity of the randomized RACING trial,” Dr. Ben-Yehuda writes.
The rationale for combination therapy is strong, but additional data would be helpful, particularly for informing guidelines, he continues. “A pragmatic trial randomizing a broad racial and ethnic group of patients to low-dose statin,” such as a starting dose of 10 mg/day atorvastatin or 5 mg/day rosuvastatin “plus ezetimibe vs. high-intensity statin alone would provide much needed data to help guide lipid-lowering therapy for millions of patients and hopefully increase persistence on therapy.”
The study was supported by the Cardiovascular Research Center, Seoul, South Korea. Dr. Hong and Dr. Ben-Yehuda have disclosed no relevant financial relationships. Dr. Bhatt has previously disclosed grants and/or personal fees from many companies; personal fees from WebMD and other publications or organizations; and having other relationships with Medscape Cardiology and other publications or organizations.
A version of this article appeared on Medscape.com.
, suggests a “real-world” cohort study that is consistent with trial evidence.
In the observational study with more than 273,000 patients who received percutaneous coronary intervention (PCI) with drug-eluting stents (DES), risk for a broad composite clinical primary endpoint fell by one-fourth (P < .001) among those put on the two-drug regimen with a moderate-intensity statin, compared with those getting a high-intensity statin alone.
The dual-agent approach was also associated with a 15% drop in statin discontinuation and a 20% reduced risk for new-onset diabetes requiring medication (P < .001 for both benefits), reported investigators in the Journal of the American College of Cardiology.
The study’s primary endpoint – a composite of cardiovascular (CV) death, myocardial infarction (MI), coronary revascularization, heart failure (HF) hospitalization, or nonfatal stroke at 3 years – replicated that of the randomized RACING trial conducted by many of the same researchers and published about a year ago in The Lancet.
RACING demonstrated that ezetimibe plus a moderate-intensity statin could be as effective as a high-intensity statin in patients with CV disease, “but have fewer side effects and better compliance,” Myeong-Ki Hong, MD, PhD, Severance Hospital, Yonsei University, Seoul, South Korea, said in an interview.
Dr. Hong is senior author on the current observational study based on the CONNECT-DES registry, which compared rosuvastatin 10 mg/day plus ezetimibe 10 mg/day – used in RACING – with rosuvastatin 20 mg/day in a nationwide cohort of 72,050 patients.
“As we know, populations who are enrolled in randomized studies do not sufficiently represent real patients in practice,” he observed, “so we wanted to evaluate the generalizability of the RACING results in daily clinical practice.”
Deepak L. Bhatt, MD, said he likes studies that look at whether clinical trial results “play out in the real world,” as this one did. “They have largely replicated the results of the RACING trial,” suggesting the approach using a moderate-intensity statin “is the way to go,” Dr. Bhatt of Mount Sinai Health System, New York, who was not affiliated with the current report, said in an interview. “In fact, the moderate-intensity combination regimen was actually better in this study.”
He said the observed reduction in new-onset diabetes with the moderate-intensity statin approach is also important. “There is a link between high-dose statins and diabetes. So, if given the choice, if you can get the benefits from a cardiovascular perspective with a lower risk of diabetes, it makes sense to use the combination therapy.”
Dr. Bhatt said he had been using high-intensity statin monotherapy in his high-risk patients, but RACING made him reconsider the value of moderate-dose statin combination therapy. “Going with lower doses of two drugs instead of high doses of one drug minimizes side effects and, in some cases, can even enhance efficacy – so this is not an unreasonable paradigm.”
In the current cohort study of patients prescribed rosuvastatin after DES implantation, 10,794 received rosuvastatin 10 mg/day plus ezetimibe 10 mg/day, and 61,256 were put on rosuvastatin 20 mg/day.
Hazard ratio risk reductions with the dual-agent lipid-lowering therapy approach, compared with high-intensity statin monotherapy, were more favorable for the primary composite clinical endpoint and important secondary events:
- HR, 0.75; 95% confidence interval, 0.70-0.79; P < .001) for CV death, MI, coronary artery revascularization, HF, or stroke at 3 years.
- HR, 0.85; 95% CI, 0.78-0.94; P = .001) for statin discontinuation.
- HR, 0.80; 95% CI, 0.72-0.88; P < .001) for new-onset diabetes requiring medication.
But HRs for rhabdomyolysis, cholecystectomy, or a new cancer diagnosis did not indicate significant differences between the two groups.
“Now that there is evidence to support the favorable clinical outcomes of combination lipid-lowering therapy with moderate-intensity statin plus ezetimibe” for secondary prevention from both RACING and a study reflecting daily clinical practice, Dr. Hong said, “physicians may feel more comfortable with this approach.”
The registry analysis “is remarkable not only for validating the results of the RACING trial in routine clinical practice in a high-risk secondary prevention population, but also for its innovative methodology,” states an accompanying editorial by Ori Ben-Yehuda, MD, Sulpizio Cardiovascular Center, University of California, San Diego.
Use of such a large single-payer database in their study “affords even greater external validity to the findings, complementing the internal validity of the randomized RACING trial,” Dr. Ben-Yehuda writes.
The rationale for combination therapy is strong, but additional data would be helpful, particularly for informing guidelines, he continues. “A pragmatic trial randomizing a broad racial and ethnic group of patients to low-dose statin,” such as a starting dose of 10 mg/day atorvastatin or 5 mg/day rosuvastatin “plus ezetimibe vs. high-intensity statin alone would provide much needed data to help guide lipid-lowering therapy for millions of patients and hopefully increase persistence on therapy.”
The study was supported by the Cardiovascular Research Center, Seoul, South Korea. Dr. Hong and Dr. Ben-Yehuda have disclosed no relevant financial relationships. Dr. Bhatt has previously disclosed grants and/or personal fees from many companies; personal fees from WebMD and other publications or organizations; and having other relationships with Medscape Cardiology and other publications or organizations.
A version of this article appeared on Medscape.com.
, suggests a “real-world” cohort study that is consistent with trial evidence.
In the observational study with more than 273,000 patients who received percutaneous coronary intervention (PCI) with drug-eluting stents (DES), risk for a broad composite clinical primary endpoint fell by one-fourth (P < .001) among those put on the two-drug regimen with a moderate-intensity statin, compared with those getting a high-intensity statin alone.
The dual-agent approach was also associated with a 15% drop in statin discontinuation and a 20% reduced risk for new-onset diabetes requiring medication (P < .001 for both benefits), reported investigators in the Journal of the American College of Cardiology.
The study’s primary endpoint – a composite of cardiovascular (CV) death, myocardial infarction (MI), coronary revascularization, heart failure (HF) hospitalization, or nonfatal stroke at 3 years – replicated that of the randomized RACING trial conducted by many of the same researchers and published about a year ago in The Lancet.
RACING demonstrated that ezetimibe plus a moderate-intensity statin could be as effective as a high-intensity statin in patients with CV disease, “but have fewer side effects and better compliance,” Myeong-Ki Hong, MD, PhD, Severance Hospital, Yonsei University, Seoul, South Korea, said in an interview.
Dr. Hong is senior author on the current observational study based on the CONNECT-DES registry, which compared rosuvastatin 10 mg/day plus ezetimibe 10 mg/day – used in RACING – with rosuvastatin 20 mg/day in a nationwide cohort of 72,050 patients.
“As we know, populations who are enrolled in randomized studies do not sufficiently represent real patients in practice,” he observed, “so we wanted to evaluate the generalizability of the RACING results in daily clinical practice.”
Deepak L. Bhatt, MD, said he likes studies that look at whether clinical trial results “play out in the real world,” as this one did. “They have largely replicated the results of the RACING trial,” suggesting the approach using a moderate-intensity statin “is the way to go,” Dr. Bhatt of Mount Sinai Health System, New York, who was not affiliated with the current report, said in an interview. “In fact, the moderate-intensity combination regimen was actually better in this study.”
He said the observed reduction in new-onset diabetes with the moderate-intensity statin approach is also important. “There is a link between high-dose statins and diabetes. So, if given the choice, if you can get the benefits from a cardiovascular perspective with a lower risk of diabetes, it makes sense to use the combination therapy.”
Dr. Bhatt said he had been using high-intensity statin monotherapy in his high-risk patients, but RACING made him reconsider the value of moderate-dose statin combination therapy. “Going with lower doses of two drugs instead of high doses of one drug minimizes side effects and, in some cases, can even enhance efficacy – so this is not an unreasonable paradigm.”
In the current cohort study of patients prescribed rosuvastatin after DES implantation, 10,794 received rosuvastatin 10 mg/day plus ezetimibe 10 mg/day, and 61,256 were put on rosuvastatin 20 mg/day.
Hazard ratio risk reductions with the dual-agent lipid-lowering therapy approach, compared with high-intensity statin monotherapy, were more favorable for the primary composite clinical endpoint and important secondary events:
- HR, 0.75; 95% confidence interval, 0.70-0.79; P < .001) for CV death, MI, coronary artery revascularization, HF, or stroke at 3 years.
- HR, 0.85; 95% CI, 0.78-0.94; P = .001) for statin discontinuation.
- HR, 0.80; 95% CI, 0.72-0.88; P < .001) for new-onset diabetes requiring medication.
But HRs for rhabdomyolysis, cholecystectomy, or a new cancer diagnosis did not indicate significant differences between the two groups.
“Now that there is evidence to support the favorable clinical outcomes of combination lipid-lowering therapy with moderate-intensity statin plus ezetimibe” for secondary prevention from both RACING and a study reflecting daily clinical practice, Dr. Hong said, “physicians may feel more comfortable with this approach.”
The registry analysis “is remarkable not only for validating the results of the RACING trial in routine clinical practice in a high-risk secondary prevention population, but also for its innovative methodology,” states an accompanying editorial by Ori Ben-Yehuda, MD, Sulpizio Cardiovascular Center, University of California, San Diego.
Use of such a large single-payer database in their study “affords even greater external validity to the findings, complementing the internal validity of the randomized RACING trial,” Dr. Ben-Yehuda writes.
The rationale for combination therapy is strong, but additional data would be helpful, particularly for informing guidelines, he continues. “A pragmatic trial randomizing a broad racial and ethnic group of patients to low-dose statin,” such as a starting dose of 10 mg/day atorvastatin or 5 mg/day rosuvastatin “plus ezetimibe vs. high-intensity statin alone would provide much needed data to help guide lipid-lowering therapy for millions of patients and hopefully increase persistence on therapy.”
The study was supported by the Cardiovascular Research Center, Seoul, South Korea. Dr. Hong and Dr. Ben-Yehuda have disclosed no relevant financial relationships. Dr. Bhatt has previously disclosed grants and/or personal fees from many companies; personal fees from WebMD and other publications or organizations; and having other relationships with Medscape Cardiology and other publications or organizations.
A version of this article appeared on Medscape.com.
FROM JACC
Invasive test may cut health care costs related to angina without obstructive CAD
Performing coronary reactivity (CR) testing during angiography in patients with angina without obstructive coronary disease (ANOCA) adds complexity and cost to the procedure but may, in the end, turn out to be a bargain.
probably by helping to limit downstream procedures and other use of health care resources.
In the retrospective study, CR testing included both adenosine and acetylcholine challenges to differentiate endothelium-dependent from endothelium-independent coronary reactivity as the physiological cause of ANOCA in individuals. Clarifying the cause at this stage of the patient’s clinical journey seemed to sharpen subsequent testing and management decisions, the researchers said.
Of the 414 patients with ANOCA who underwent invasive diagnostic angiography, 207 also received CR testing during the procedure. The difference in total healthcare costs between the two groups over 2 years averaged about $20,000, largely because of the CR-testing group’s reduced use of downstream imaging, interventional procedures, and other tests, notes a report on the study published in Circulation: Cardiovascular Interventions.
For such patients referred for coronary angiography found to be without obstructive disease, “the right thing to do is a vascular reactivity test to assess if there is any abnormality that can contribute to this patient’s symptoms and events,” senior author Amir Lerman, MD, Mayo Clinic, Rochester, Minn., said in an interview. Coronary reactivity testing “is expensive to set up initially, but it actually saves money by reducing the need for additional unnecessary testing and hospitalizations in these patients.”
The financial burden linked to the diagnosis and treatment of patients with chest pain is considerable, Dr. Lerman observed. It can involve a series of tests and culminate in a coronary angiogram. However, symptoms may continue if therapy does not correctly target one or more of several different potential mechanisms, including microvascular dysfunction and vasospastic disorders.
“This paper says that if you establish a program of coronary reactivity testing you will ultimately reduce health care costs, because patients stop coming back to the hospital, or their physician stops ordering more tests or repeat angiograms because the patient has a true diagnosis,” observed Morton J. Kern, MD, University of California, Irvine, and VA Long Beach (Calif.) Health Care.
“That elimination of uncertainty and reduction of testing has a good payoff,” Dr. Kern said in an interview. “The concept is good; the only challenge is that this is a complicated set of manipulations in the cath lab to get to the results.”
A minority of cardiac cath labs in the United States perform CR testing, despite its inclusion for ANOCA in guidelines from both the European Society of Cardiology and the American Heart Association/American College of Cardiology, the authors noted. Cost and its requirement for specialized expertise may contribute to its poor uptake in practice.
In an editorial accompanying the report, Dr. Kern and David J. Cohen, MD, Cardiovascular Research Foundation, New York, and St. Francis Hospital and Heart Center, Roslyn, N.Y., said they agree with the authors’ recommendation for more widespread use of CR testing.
However, the initiation of a CR testing program is no small task. “In addition to motivated practitioners, operators with specific procedural expertise must have formalized technical training to produce valid results and to limit the procedural risks,” they wrote.
Moreover, expenses for a CR testing program “will likely be incurred without balanced reimbursement, but the health care system will benefit in the long run.”
The total health-related costs for the two groups of 207 in the analysis were tracked for 2 years after the procedure and found to be significantly higher (P < .001) in the group that had received coronary angiography without CR testing. Their average annual cost was $37,804 (range, $26,933-$48,674), compared with $13,679 (range, $9,447-$17,910) for those that had undergone CR testing.
The angiography-only group’s costs for procedures (including surgical or percutaneous intervention, endoscopy, and bronchoscopy) averaged $5,872 (range, $3,798-$7,946), compared with $2,104 (range, $1,202-$3,006) in the CR testing group (P = .001).
Similarly, costs for any type of imaging, including at cardiac catheterization, averaged $2,639 (range, $2,093 to $3,185) and $1,426 (range, $1,090 to $1,761), respectively (P < .001).
Annual total hospital services costs were also higher in the angiography-only group at $21,820 versus $6,409 (P < .001) for the group that underwent CR testing.
Caution is required when interpreting these results, Matthew Tomey, MD, Mount Sinai Morningside Hospital and Icahn School of Medicine at Mount Sinai, New York, said in an interview.
“The observed cost differences are interesting and hypothesis generating but they fall short of providing strong evidence that [CR testing] saves money or that [it] should be incorporated into routine practice,” Dr. Tomey said. “Multiple biases can skew findings of retrospective observational studies. A prospective, randomized study would be needed to draw stronger conclusions.”
Still, it’s true that “there is substantial opportunity to do better in diagnosing chest pain in our patients with no apparent, explanatory obstructive coronary atherosclerosis,” he said. “There are emerging invasive and noninvasive ways to do so. Helping our patients get to the right diagnosis is the right thing to do. It will lead to better treatment recommendations, improved patient symptoms, improved patient confidence, and – it stands to reason – cost benefits in the long term.”
The study was funded by a grant from Philips. Dr. Lerman reported receiving honoraria from Philips Volcano. Dr. Kern disclosed speaking for Abbott Vascular, Boston Scientific, Acist, Opsens, and Zoll. Dr. Cohen disclosed receiving institutional grant support from Abbott Vascular, Boston Scientific, CathWorks, and Philips; and consulting income from Abbott, Boston Scientific, and Medtronic. Dr. Tomey reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Performing coronary reactivity (CR) testing during angiography in patients with angina without obstructive coronary disease (ANOCA) adds complexity and cost to the procedure but may, in the end, turn out to be a bargain.
probably by helping to limit downstream procedures and other use of health care resources.
In the retrospective study, CR testing included both adenosine and acetylcholine challenges to differentiate endothelium-dependent from endothelium-independent coronary reactivity as the physiological cause of ANOCA in individuals. Clarifying the cause at this stage of the patient’s clinical journey seemed to sharpen subsequent testing and management decisions, the researchers said.
Of the 414 patients with ANOCA who underwent invasive diagnostic angiography, 207 also received CR testing during the procedure. The difference in total healthcare costs between the two groups over 2 years averaged about $20,000, largely because of the CR-testing group’s reduced use of downstream imaging, interventional procedures, and other tests, notes a report on the study published in Circulation: Cardiovascular Interventions.
For such patients referred for coronary angiography found to be without obstructive disease, “the right thing to do is a vascular reactivity test to assess if there is any abnormality that can contribute to this patient’s symptoms and events,” senior author Amir Lerman, MD, Mayo Clinic, Rochester, Minn., said in an interview. Coronary reactivity testing “is expensive to set up initially, but it actually saves money by reducing the need for additional unnecessary testing and hospitalizations in these patients.”
The financial burden linked to the diagnosis and treatment of patients with chest pain is considerable, Dr. Lerman observed. It can involve a series of tests and culminate in a coronary angiogram. However, symptoms may continue if therapy does not correctly target one or more of several different potential mechanisms, including microvascular dysfunction and vasospastic disorders.
“This paper says that if you establish a program of coronary reactivity testing you will ultimately reduce health care costs, because patients stop coming back to the hospital, or their physician stops ordering more tests or repeat angiograms because the patient has a true diagnosis,” observed Morton J. Kern, MD, University of California, Irvine, and VA Long Beach (Calif.) Health Care.
“That elimination of uncertainty and reduction of testing has a good payoff,” Dr. Kern said in an interview. “The concept is good; the only challenge is that this is a complicated set of manipulations in the cath lab to get to the results.”
A minority of cardiac cath labs in the United States perform CR testing, despite its inclusion for ANOCA in guidelines from both the European Society of Cardiology and the American Heart Association/American College of Cardiology, the authors noted. Cost and its requirement for specialized expertise may contribute to its poor uptake in practice.
In an editorial accompanying the report, Dr. Kern and David J. Cohen, MD, Cardiovascular Research Foundation, New York, and St. Francis Hospital and Heart Center, Roslyn, N.Y., said they agree with the authors’ recommendation for more widespread use of CR testing.
However, the initiation of a CR testing program is no small task. “In addition to motivated practitioners, operators with specific procedural expertise must have formalized technical training to produce valid results and to limit the procedural risks,” they wrote.
Moreover, expenses for a CR testing program “will likely be incurred without balanced reimbursement, but the health care system will benefit in the long run.”
The total health-related costs for the two groups of 207 in the analysis were tracked for 2 years after the procedure and found to be significantly higher (P < .001) in the group that had received coronary angiography without CR testing. Their average annual cost was $37,804 (range, $26,933-$48,674), compared with $13,679 (range, $9,447-$17,910) for those that had undergone CR testing.
The angiography-only group’s costs for procedures (including surgical or percutaneous intervention, endoscopy, and bronchoscopy) averaged $5,872 (range, $3,798-$7,946), compared with $2,104 (range, $1,202-$3,006) in the CR testing group (P = .001).
Similarly, costs for any type of imaging, including at cardiac catheterization, averaged $2,639 (range, $2,093 to $3,185) and $1,426 (range, $1,090 to $1,761), respectively (P < .001).
Annual total hospital services costs were also higher in the angiography-only group at $21,820 versus $6,409 (P < .001) for the group that underwent CR testing.
Caution is required when interpreting these results, Matthew Tomey, MD, Mount Sinai Morningside Hospital and Icahn School of Medicine at Mount Sinai, New York, said in an interview.
“The observed cost differences are interesting and hypothesis generating but they fall short of providing strong evidence that [CR testing] saves money or that [it] should be incorporated into routine practice,” Dr. Tomey said. “Multiple biases can skew findings of retrospective observational studies. A prospective, randomized study would be needed to draw stronger conclusions.”
Still, it’s true that “there is substantial opportunity to do better in diagnosing chest pain in our patients with no apparent, explanatory obstructive coronary atherosclerosis,” he said. “There are emerging invasive and noninvasive ways to do so. Helping our patients get to the right diagnosis is the right thing to do. It will lead to better treatment recommendations, improved patient symptoms, improved patient confidence, and – it stands to reason – cost benefits in the long term.”
The study was funded by a grant from Philips. Dr. Lerman reported receiving honoraria from Philips Volcano. Dr. Kern disclosed speaking for Abbott Vascular, Boston Scientific, Acist, Opsens, and Zoll. Dr. Cohen disclosed receiving institutional grant support from Abbott Vascular, Boston Scientific, CathWorks, and Philips; and consulting income from Abbott, Boston Scientific, and Medtronic. Dr. Tomey reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Performing coronary reactivity (CR) testing during angiography in patients with angina without obstructive coronary disease (ANOCA) adds complexity and cost to the procedure but may, in the end, turn out to be a bargain.
probably by helping to limit downstream procedures and other use of health care resources.
In the retrospective study, CR testing included both adenosine and acetylcholine challenges to differentiate endothelium-dependent from endothelium-independent coronary reactivity as the physiological cause of ANOCA in individuals. Clarifying the cause at this stage of the patient’s clinical journey seemed to sharpen subsequent testing and management decisions, the researchers said.
Of the 414 patients with ANOCA who underwent invasive diagnostic angiography, 207 also received CR testing during the procedure. The difference in total healthcare costs between the two groups over 2 years averaged about $20,000, largely because of the CR-testing group’s reduced use of downstream imaging, interventional procedures, and other tests, notes a report on the study published in Circulation: Cardiovascular Interventions.
For such patients referred for coronary angiography found to be without obstructive disease, “the right thing to do is a vascular reactivity test to assess if there is any abnormality that can contribute to this patient’s symptoms and events,” senior author Amir Lerman, MD, Mayo Clinic, Rochester, Minn., said in an interview. Coronary reactivity testing “is expensive to set up initially, but it actually saves money by reducing the need for additional unnecessary testing and hospitalizations in these patients.”
The financial burden linked to the diagnosis and treatment of patients with chest pain is considerable, Dr. Lerman observed. It can involve a series of tests and culminate in a coronary angiogram. However, symptoms may continue if therapy does not correctly target one or more of several different potential mechanisms, including microvascular dysfunction and vasospastic disorders.
“This paper says that if you establish a program of coronary reactivity testing you will ultimately reduce health care costs, because patients stop coming back to the hospital, or their physician stops ordering more tests or repeat angiograms because the patient has a true diagnosis,” observed Morton J. Kern, MD, University of California, Irvine, and VA Long Beach (Calif.) Health Care.
“That elimination of uncertainty and reduction of testing has a good payoff,” Dr. Kern said in an interview. “The concept is good; the only challenge is that this is a complicated set of manipulations in the cath lab to get to the results.”
A minority of cardiac cath labs in the United States perform CR testing, despite its inclusion for ANOCA in guidelines from both the European Society of Cardiology and the American Heart Association/American College of Cardiology, the authors noted. Cost and its requirement for specialized expertise may contribute to its poor uptake in practice.
In an editorial accompanying the report, Dr. Kern and David J. Cohen, MD, Cardiovascular Research Foundation, New York, and St. Francis Hospital and Heart Center, Roslyn, N.Y., said they agree with the authors’ recommendation for more widespread use of CR testing.
However, the initiation of a CR testing program is no small task. “In addition to motivated practitioners, operators with specific procedural expertise must have formalized technical training to produce valid results and to limit the procedural risks,” they wrote.
Moreover, expenses for a CR testing program “will likely be incurred without balanced reimbursement, but the health care system will benefit in the long run.”
The total health-related costs for the two groups of 207 in the analysis were tracked for 2 years after the procedure and found to be significantly higher (P < .001) in the group that had received coronary angiography without CR testing. Their average annual cost was $37,804 (range, $26,933-$48,674), compared with $13,679 (range, $9,447-$17,910) for those that had undergone CR testing.
The angiography-only group’s costs for procedures (including surgical or percutaneous intervention, endoscopy, and bronchoscopy) averaged $5,872 (range, $3,798-$7,946), compared with $2,104 (range, $1,202-$3,006) in the CR testing group (P = .001).
Similarly, costs for any type of imaging, including at cardiac catheterization, averaged $2,639 (range, $2,093 to $3,185) and $1,426 (range, $1,090 to $1,761), respectively (P < .001).
Annual total hospital services costs were also higher in the angiography-only group at $21,820 versus $6,409 (P < .001) for the group that underwent CR testing.
Caution is required when interpreting these results, Matthew Tomey, MD, Mount Sinai Morningside Hospital and Icahn School of Medicine at Mount Sinai, New York, said in an interview.
“The observed cost differences are interesting and hypothesis generating but they fall short of providing strong evidence that [CR testing] saves money or that [it] should be incorporated into routine practice,” Dr. Tomey said. “Multiple biases can skew findings of retrospective observational studies. A prospective, randomized study would be needed to draw stronger conclusions.”
Still, it’s true that “there is substantial opportunity to do better in diagnosing chest pain in our patients with no apparent, explanatory obstructive coronary atherosclerosis,” he said. “There are emerging invasive and noninvasive ways to do so. Helping our patients get to the right diagnosis is the right thing to do. It will lead to better treatment recommendations, improved patient symptoms, improved patient confidence, and – it stands to reason – cost benefits in the long term.”
The study was funded by a grant from Philips. Dr. Lerman reported receiving honoraria from Philips Volcano. Dr. Kern disclosed speaking for Abbott Vascular, Boston Scientific, Acist, Opsens, and Zoll. Dr. Cohen disclosed receiving institutional grant support from Abbott Vascular, Boston Scientific, CathWorks, and Philips; and consulting income from Abbott, Boston Scientific, and Medtronic. Dr. Tomey reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CIRCULATION: CARDIOVASCULAR INTERVENTIONS