User login
Adding salt to food linked to higher risk of premature death
in a new study.
In the study of more than 500,000 people, compared with those who never or rarely added salt, those who always added salt to their food had a 28% increased risk of dying prematurely (defined as death before the age of 75 years).
Results also showed that adding salt to food was linked to a lower life expectancy. At the age of 50 years, life expectancy was reduced by 1.5 years in women and by 2.28 years in men who always added salt to their food, compared with those who never or rarely did.
However, these increased risks appeared to be attenuated with increasing intakes of high-potassium foods (vegetables and fruits).
The study was published online in the European Heart Journal.
“As far as we are aware, this is the first study to analyze adding salt to meals as a unique measurement for dietary sodium intake. Such a measure is less likely affected by other dietary components, especially potassium intake,” senior author Lu Qi, MD, Tulane University, New Orleans, told this news organization.
“Our study provides supportive evidence from a novel perspective to show the adverse effects of high sodium intake on human health, which is still a controversial topic. Our findings support the advice that reduction of salt intake by reducing the salt added to meals may benefit health and improve life expectancy. Our results also suggest that high intakes of fruits and vegetables are beneficial regarding lowering the adverse effects of salt,” he added.
Link between dietary salt and health is subject of longstanding debate
The researchers explained that the relationship between dietary salt intake and health remains a subject of longstanding debate, with previous studies on the association between sodium intake and mortality having shown conflicting results.
They attributed the inconsistent results to the low accuracy of sodium measurement, noting that sodium intake varies widely from day to day, but the majority of previous studies have largely relied on a single day’s urine collection or dietary survey for estimating the sodium intake, which is inadequate to assess an individual’s usual consumption levels.
They also pointed out that it is difficult to separate the contributions of intakes of sodium and potassium to health based on current methods for measuring dietary sodium and potassium, and this may confound the association between sodium intake and health outcomes.
They noted that the hypothesis that a high-potassium intake may attenuate the adverse association of high-sodium intake with health outcomes has been proposed for many years, but studies assessing the interaction between sodium intake and potassium intake on the risk of mortality are scarce.
Adding salt to food at the table is a common eating behavior directly related to an individual’s long-term preference for salty tasting foods and habitual salt intake, the authors said, adding that commonly used table salt contains 97%-99% sodium chloride, minimizing the potential confounding effects of other dietary factors including potassium. “Therefore, adding salt to foods provides a unique assessment to evaluate the association between habitual sodium intake and mortality.”
UK Biobank study
For the current study Dr. Qi and colleagues analyzed data from 501,379 people taking part in the UK Biobank study. When joining the study between 2006 and 2010, the participants were asked whether they added salt to their foods never/rarely, sometimes, usually or always. Participants were then followed for a median of 9 years.
After adjustment for sex, age, race, smoking, moderate drinking, body mass index, physical activity, Townsend deprivation index, high cholesterol, chronic kidney disease, diabetes, cardiovascular disease, and cancer, results showed an increasing risk of all-cause premature mortality rose with increasing frequency of adding salt to foods.
The adjusted hazard ratios, compared with those who never or rarely added salt, were 1.02 (95% CI, 0.99-1.06) for those who added salt sometimes, 1.07 (95% CI, 1.02-1.11) for those who usually added salt, and 1.28 (95% CI, 1.20-1.35) for those who always added salt.
The researchers also estimated the lower survival time caused by the high frequency of adding salt to foods. At age 50, women who always added salt to foods had an average 1.50 fewer years of life expectancy, and men who always added salt had an average 2.28 fewer years of life expectancy, as compared with their counterparts who never/rarely added salt to foods.
For cause-specific premature mortality, results showed that higher frequency of adding salt to foods was significantly associated with a higher risk of cardiovascular mortality and cancer mortality, but not for dementia mortality or respiratory mortality. For the subtypes of cardiovascular mortality, adding salt to foods was significantly associated with higher risk of stroke mortality but not coronary heart disease mortality.
Other analyses suggested that the association of adding salt to foods with an increased risk of premature mortality appeared to be attenuated with increasing intake of food high in potassium (fruits and vegetables).
The authors point out that the amounts of discretionary sodium intake (the salt used at the table or in home cooking) have been largely overlooked in previous studies, even though adding salt to foods accounts for a considerable proportion of total sodium intake (6%-20%) in Western diets.
“Our findings also support the notion that even a modest reduction in sodium intake is likely to result in substantial health benefits, especially when it is achieved in the general population,” they conclude.
Conflicting information from different studies
But the current findings seem to directly contradict those from another recent study by Messerli and colleagues showing higher sodium intake correlates with improved life expectancy.
Addressing these contradictory results, Dr. Qi commented: “The study of Messerli et al. is based on an ecological design, in which the analysis is performed on country average sodium intake, rather than at the individual level. This type of ecological study has several major limitations, such as the lack of individuals’ sodium intake, uncontrolled confounding, and the cross-sectional nature. Typically, ecological studies are not considered useful for testing hypothesis in epidemiological studies.”
Dr. Qi noted that, in contrast, his current study analyzes individuals’ exposure, and has a prospective design. “Our findings are supported by previous large-scale observational studies and clinical trials which show the high intake of sodium may adversely affect chronic diseases such as cardiovascular disease and hypertension.” =
Lead author of the ecological study, Franz Messerli, MD, Bern (Switzerland) University Hospital, however, was not convinced by the findings from Dr. Qi’s study.
“The difference in 24-hour sodium intake between those who never/rarely added salt and those who always did is a minuscule 0.17 g. It is highly unlikely that such negligible quantity has any impact on blood pressure, not to mention cardiovascular mortality or life expectancy,” he commented in an interview.
He also pointed out that, in Dr. Qi’s study, people who added salt more frequently also consumed more red meat and processed meat, as well as less fish and less fruit and vegetables. “I would suggest that the bad habit of adding salt at the table is simply a powerful marker for an unhealthy diet.”
“There is no question that an excessive salt intake is harmful in hypertensive patients and increases the risk of stroke. But 0.17 g is not going to make any difference,” Dr. Messerli added.
What is the optimum level?
In an editorial accompanying the study by Dr. Qi and colleagues in the European Heart Journal, Annika Rosengren, MD, PhD, Sahlgrenska University Hospital, Gothenburg, Sweden, noted that guidelines recommend a salt intake below 5 g, or about a teaspoon, per day. But few individuals meet this recommendation.
Because several recent studies show a U- or J-shaped association between salt and atherosclerotic cardiovascular disease, reducing salt intake across the whole population may not be universally beneficial, Dr. Rosengren said.
“So far, what the collective evidence about salt seems to indicate is that healthy people consuming what constitutes normal levels of ordinary salt need not worry too much about their salt intake,” she wrote.
Instead, she advised a diet rich in fruit and vegetables should be a priority to counterbalance potentially harmful effects of salt, and for many other reasons.
And she added that people at high risk, such as those with hypertension who have a high salt intake, are probably well advised to cut down, and not adding extra salt to already prepared foods is one way of achieving this. However, at the individual level, the optimal salt consumption range, or the “sweet spot” remains to be determined.
“Not adding extra salt to food is unlikely to be harmful and could contribute to strategies to lower population blood pressure levels,” Dr. Rosengren concluded.
A version of this article first appeared on Medscape.com.
in a new study.
In the study of more than 500,000 people, compared with those who never or rarely added salt, those who always added salt to their food had a 28% increased risk of dying prematurely (defined as death before the age of 75 years).
Results also showed that adding salt to food was linked to a lower life expectancy. At the age of 50 years, life expectancy was reduced by 1.5 years in women and by 2.28 years in men who always added salt to their food, compared with those who never or rarely did.
However, these increased risks appeared to be attenuated with increasing intakes of high-potassium foods (vegetables and fruits).
The study was published online in the European Heart Journal.
“As far as we are aware, this is the first study to analyze adding salt to meals as a unique measurement for dietary sodium intake. Such a measure is less likely affected by other dietary components, especially potassium intake,” senior author Lu Qi, MD, Tulane University, New Orleans, told this news organization.
“Our study provides supportive evidence from a novel perspective to show the adverse effects of high sodium intake on human health, which is still a controversial topic. Our findings support the advice that reduction of salt intake by reducing the salt added to meals may benefit health and improve life expectancy. Our results also suggest that high intakes of fruits and vegetables are beneficial regarding lowering the adverse effects of salt,” he added.
Link between dietary salt and health is subject of longstanding debate
The researchers explained that the relationship between dietary salt intake and health remains a subject of longstanding debate, with previous studies on the association between sodium intake and mortality having shown conflicting results.
They attributed the inconsistent results to the low accuracy of sodium measurement, noting that sodium intake varies widely from day to day, but the majority of previous studies have largely relied on a single day’s urine collection or dietary survey for estimating the sodium intake, which is inadequate to assess an individual’s usual consumption levels.
They also pointed out that it is difficult to separate the contributions of intakes of sodium and potassium to health based on current methods for measuring dietary sodium and potassium, and this may confound the association between sodium intake and health outcomes.
They noted that the hypothesis that a high-potassium intake may attenuate the adverse association of high-sodium intake with health outcomes has been proposed for many years, but studies assessing the interaction between sodium intake and potassium intake on the risk of mortality are scarce.
Adding salt to food at the table is a common eating behavior directly related to an individual’s long-term preference for salty tasting foods and habitual salt intake, the authors said, adding that commonly used table salt contains 97%-99% sodium chloride, minimizing the potential confounding effects of other dietary factors including potassium. “Therefore, adding salt to foods provides a unique assessment to evaluate the association between habitual sodium intake and mortality.”
UK Biobank study
For the current study Dr. Qi and colleagues analyzed data from 501,379 people taking part in the UK Biobank study. When joining the study between 2006 and 2010, the participants were asked whether they added salt to their foods never/rarely, sometimes, usually or always. Participants were then followed for a median of 9 years.
After adjustment for sex, age, race, smoking, moderate drinking, body mass index, physical activity, Townsend deprivation index, high cholesterol, chronic kidney disease, diabetes, cardiovascular disease, and cancer, results showed an increasing risk of all-cause premature mortality rose with increasing frequency of adding salt to foods.
The adjusted hazard ratios, compared with those who never or rarely added salt, were 1.02 (95% CI, 0.99-1.06) for those who added salt sometimes, 1.07 (95% CI, 1.02-1.11) for those who usually added salt, and 1.28 (95% CI, 1.20-1.35) for those who always added salt.
The researchers also estimated the lower survival time caused by the high frequency of adding salt to foods. At age 50, women who always added salt to foods had an average 1.50 fewer years of life expectancy, and men who always added salt had an average 2.28 fewer years of life expectancy, as compared with their counterparts who never/rarely added salt to foods.
For cause-specific premature mortality, results showed that higher frequency of adding salt to foods was significantly associated with a higher risk of cardiovascular mortality and cancer mortality, but not for dementia mortality or respiratory mortality. For the subtypes of cardiovascular mortality, adding salt to foods was significantly associated with higher risk of stroke mortality but not coronary heart disease mortality.
Other analyses suggested that the association of adding salt to foods with an increased risk of premature mortality appeared to be attenuated with increasing intake of food high in potassium (fruits and vegetables).
The authors point out that the amounts of discretionary sodium intake (the salt used at the table or in home cooking) have been largely overlooked in previous studies, even though adding salt to foods accounts for a considerable proportion of total sodium intake (6%-20%) in Western diets.
“Our findings also support the notion that even a modest reduction in sodium intake is likely to result in substantial health benefits, especially when it is achieved in the general population,” they conclude.
Conflicting information from different studies
But the current findings seem to directly contradict those from another recent study by Messerli and colleagues showing higher sodium intake correlates with improved life expectancy.
Addressing these contradictory results, Dr. Qi commented: “The study of Messerli et al. is based on an ecological design, in which the analysis is performed on country average sodium intake, rather than at the individual level. This type of ecological study has several major limitations, such as the lack of individuals’ sodium intake, uncontrolled confounding, and the cross-sectional nature. Typically, ecological studies are not considered useful for testing hypothesis in epidemiological studies.”
Dr. Qi noted that, in contrast, his current study analyzes individuals’ exposure, and has a prospective design. “Our findings are supported by previous large-scale observational studies and clinical trials which show the high intake of sodium may adversely affect chronic diseases such as cardiovascular disease and hypertension.” =
Lead author of the ecological study, Franz Messerli, MD, Bern (Switzerland) University Hospital, however, was not convinced by the findings from Dr. Qi’s study.
“The difference in 24-hour sodium intake between those who never/rarely added salt and those who always did is a minuscule 0.17 g. It is highly unlikely that such negligible quantity has any impact on blood pressure, not to mention cardiovascular mortality or life expectancy,” he commented in an interview.
He also pointed out that, in Dr. Qi’s study, people who added salt more frequently also consumed more red meat and processed meat, as well as less fish and less fruit and vegetables. “I would suggest that the bad habit of adding salt at the table is simply a powerful marker for an unhealthy diet.”
“There is no question that an excessive salt intake is harmful in hypertensive patients and increases the risk of stroke. But 0.17 g is not going to make any difference,” Dr. Messerli added.
What is the optimum level?
In an editorial accompanying the study by Dr. Qi and colleagues in the European Heart Journal, Annika Rosengren, MD, PhD, Sahlgrenska University Hospital, Gothenburg, Sweden, noted that guidelines recommend a salt intake below 5 g, or about a teaspoon, per day. But few individuals meet this recommendation.
Because several recent studies show a U- or J-shaped association between salt and atherosclerotic cardiovascular disease, reducing salt intake across the whole population may not be universally beneficial, Dr. Rosengren said.
“So far, what the collective evidence about salt seems to indicate is that healthy people consuming what constitutes normal levels of ordinary salt need not worry too much about their salt intake,” she wrote.
Instead, she advised a diet rich in fruit and vegetables should be a priority to counterbalance potentially harmful effects of salt, and for many other reasons.
And she added that people at high risk, such as those with hypertension who have a high salt intake, are probably well advised to cut down, and not adding extra salt to already prepared foods is one way of achieving this. However, at the individual level, the optimal salt consumption range, or the “sweet spot” remains to be determined.
“Not adding extra salt to food is unlikely to be harmful and could contribute to strategies to lower population blood pressure levels,” Dr. Rosengren concluded.
A version of this article first appeared on Medscape.com.
in a new study.
In the study of more than 500,000 people, compared with those who never or rarely added salt, those who always added salt to their food had a 28% increased risk of dying prematurely (defined as death before the age of 75 years).
Results also showed that adding salt to food was linked to a lower life expectancy. At the age of 50 years, life expectancy was reduced by 1.5 years in women and by 2.28 years in men who always added salt to their food, compared with those who never or rarely did.
However, these increased risks appeared to be attenuated with increasing intakes of high-potassium foods (vegetables and fruits).
The study was published online in the European Heart Journal.
“As far as we are aware, this is the first study to analyze adding salt to meals as a unique measurement for dietary sodium intake. Such a measure is less likely affected by other dietary components, especially potassium intake,” senior author Lu Qi, MD, Tulane University, New Orleans, told this news organization.
“Our study provides supportive evidence from a novel perspective to show the adverse effects of high sodium intake on human health, which is still a controversial topic. Our findings support the advice that reduction of salt intake by reducing the salt added to meals may benefit health and improve life expectancy. Our results also suggest that high intakes of fruits and vegetables are beneficial regarding lowering the adverse effects of salt,” he added.
Link between dietary salt and health is subject of longstanding debate
The researchers explained that the relationship between dietary salt intake and health remains a subject of longstanding debate, with previous studies on the association between sodium intake and mortality having shown conflicting results.
They attributed the inconsistent results to the low accuracy of sodium measurement, noting that sodium intake varies widely from day to day, but the majority of previous studies have largely relied on a single day’s urine collection or dietary survey for estimating the sodium intake, which is inadequate to assess an individual’s usual consumption levels.
They also pointed out that it is difficult to separate the contributions of intakes of sodium and potassium to health based on current methods for measuring dietary sodium and potassium, and this may confound the association between sodium intake and health outcomes.
They noted that the hypothesis that a high-potassium intake may attenuate the adverse association of high-sodium intake with health outcomes has been proposed for many years, but studies assessing the interaction between sodium intake and potassium intake on the risk of mortality are scarce.
Adding salt to food at the table is a common eating behavior directly related to an individual’s long-term preference for salty tasting foods and habitual salt intake, the authors said, adding that commonly used table salt contains 97%-99% sodium chloride, minimizing the potential confounding effects of other dietary factors including potassium. “Therefore, adding salt to foods provides a unique assessment to evaluate the association between habitual sodium intake and mortality.”
UK Biobank study
For the current study Dr. Qi and colleagues analyzed data from 501,379 people taking part in the UK Biobank study. When joining the study between 2006 and 2010, the participants were asked whether they added salt to their foods never/rarely, sometimes, usually or always. Participants were then followed for a median of 9 years.
After adjustment for sex, age, race, smoking, moderate drinking, body mass index, physical activity, Townsend deprivation index, high cholesterol, chronic kidney disease, diabetes, cardiovascular disease, and cancer, results showed an increasing risk of all-cause premature mortality rose with increasing frequency of adding salt to foods.
The adjusted hazard ratios, compared with those who never or rarely added salt, were 1.02 (95% CI, 0.99-1.06) for those who added salt sometimes, 1.07 (95% CI, 1.02-1.11) for those who usually added salt, and 1.28 (95% CI, 1.20-1.35) for those who always added salt.
The researchers also estimated the lower survival time caused by the high frequency of adding salt to foods. At age 50, women who always added salt to foods had an average 1.50 fewer years of life expectancy, and men who always added salt had an average 2.28 fewer years of life expectancy, as compared with their counterparts who never/rarely added salt to foods.
For cause-specific premature mortality, results showed that higher frequency of adding salt to foods was significantly associated with a higher risk of cardiovascular mortality and cancer mortality, but not for dementia mortality or respiratory mortality. For the subtypes of cardiovascular mortality, adding salt to foods was significantly associated with higher risk of stroke mortality but not coronary heart disease mortality.
Other analyses suggested that the association of adding salt to foods with an increased risk of premature mortality appeared to be attenuated with increasing intake of food high in potassium (fruits and vegetables).
The authors point out that the amounts of discretionary sodium intake (the salt used at the table or in home cooking) have been largely overlooked in previous studies, even though adding salt to foods accounts for a considerable proportion of total sodium intake (6%-20%) in Western diets.
“Our findings also support the notion that even a modest reduction in sodium intake is likely to result in substantial health benefits, especially when it is achieved in the general population,” they conclude.
Conflicting information from different studies
But the current findings seem to directly contradict those from another recent study by Messerli and colleagues showing higher sodium intake correlates with improved life expectancy.
Addressing these contradictory results, Dr. Qi commented: “The study of Messerli et al. is based on an ecological design, in which the analysis is performed on country average sodium intake, rather than at the individual level. This type of ecological study has several major limitations, such as the lack of individuals’ sodium intake, uncontrolled confounding, and the cross-sectional nature. Typically, ecological studies are not considered useful for testing hypothesis in epidemiological studies.”
Dr. Qi noted that, in contrast, his current study analyzes individuals’ exposure, and has a prospective design. “Our findings are supported by previous large-scale observational studies and clinical trials which show the high intake of sodium may adversely affect chronic diseases such as cardiovascular disease and hypertension.” =
Lead author of the ecological study, Franz Messerli, MD, Bern (Switzerland) University Hospital, however, was not convinced by the findings from Dr. Qi’s study.
“The difference in 24-hour sodium intake between those who never/rarely added salt and those who always did is a minuscule 0.17 g. It is highly unlikely that such negligible quantity has any impact on blood pressure, not to mention cardiovascular mortality or life expectancy,” he commented in an interview.
He also pointed out that, in Dr. Qi’s study, people who added salt more frequently also consumed more red meat and processed meat, as well as less fish and less fruit and vegetables. “I would suggest that the bad habit of adding salt at the table is simply a powerful marker for an unhealthy diet.”
“There is no question that an excessive salt intake is harmful in hypertensive patients and increases the risk of stroke. But 0.17 g is not going to make any difference,” Dr. Messerli added.
What is the optimum level?
In an editorial accompanying the study by Dr. Qi and colleagues in the European Heart Journal, Annika Rosengren, MD, PhD, Sahlgrenska University Hospital, Gothenburg, Sweden, noted that guidelines recommend a salt intake below 5 g, or about a teaspoon, per day. But few individuals meet this recommendation.
Because several recent studies show a U- or J-shaped association between salt and atherosclerotic cardiovascular disease, reducing salt intake across the whole population may not be universally beneficial, Dr. Rosengren said.
“So far, what the collective evidence about salt seems to indicate is that healthy people consuming what constitutes normal levels of ordinary salt need not worry too much about their salt intake,” she wrote.
Instead, she advised a diet rich in fruit and vegetables should be a priority to counterbalance potentially harmful effects of salt, and for many other reasons.
And she added that people at high risk, such as those with hypertension who have a high salt intake, are probably well advised to cut down, and not adding extra salt to already prepared foods is one way of achieving this. However, at the individual level, the optimal salt consumption range, or the “sweet spot” remains to be determined.
“Not adding extra salt to food is unlikely to be harmful and could contribute to strategies to lower population blood pressure levels,” Dr. Rosengren concluded.
A version of this article first appeared on Medscape.com.
FROM THE EUROPEAN HEART JOURNAL
Access to certified stroke centers divided by race, income
Hospitals in low-income and rural areas of the United States are much less likely to adopt stroke certification than hospitals in high-income and urban communities, a new study shows.
Further, other results showed that, after adjustment for population and hospital size, access to stroke-certified hospitals is significantly lower in Black, racially segregated communities.
The study was published online in JAMA Neurology.
Noting that stroke-certified hospitals provide higher-quality stroke care, the authors, led by Yu-Chu Shen, PhD, Naval Postgraduate School, Monterey, Calif., conclude that: “Our findings suggest that structural inequities in stroke care may be an important consideration in eliminating stroke disparities for vulnerable populations.”
In an audio interview on the JAMA Neurology website, senior author Renee Y. Hsia, MD, University of California, San Francisco, said: “Our findings show there are clear disparities in which communities are getting access to stroke certified hospitals.”
She called for more help for hospitals in underserved areas to obtain stroke certification.
Dr. Hsia explained that hospitals can seek certification at their own expense and that although stroke care is expensive, it is also lucrative in terms of reimbursement. So it tends to be the private for-profit hospitals that seek these certifications. “If you are a county hospital on a really tight budget, you’re not going to have the extra cash on hand to be applying for stroke certification,” she commented.
This can result in an increase in hospitals with stroke certification – but not in the areas that need it the most.
Dr. Hsia points out that this has happened in cardiac care. One study showed a 44% increase in hospitals providing percutaneous coronary intervention over a 10-year period, but the percentage of the population that had better access increased by less than 1%.
“In general, in the United States we have a mentality that ‘more is better,’ and because there is no government regulation in health care, any time a hospital applies for these specialized services we just generally think that’s a good thing. But this might not always be the case,” Dr. Hsia noted. “We have a very market-based approach, and this doesn’t lead to equity. It leads to profit maximization, and that is not synonymous with what’s good for patients or populations.”
She suggested that in future the process of certification should include some consideration of how it will affect population-based equity.
“Rather than rubber stamping an application just because hospitals have certain resources, we need to ask what the benefit is of providing this service,” Dr. Hsia said. “Does this community really need it? If not, maybe we should invest these resources into helping a hospital in a community that needs it more.”
Dr. Hsia explained that she and her colleagues conducted their study to investigate whether there were structural issues that might be contributing to disparities in stroke care.
“We like to think emergency stroke care is equitable. Anyone can call 911 or go the emergency room. But, actually, there is a big disparity on who receives what type of care,” she said. “We know Black patients are less likely to receive thrombolytics and mechanical thrombectomy compared to White patents. And wealthy patients are more likely to receive thrombectomy compared to patients from the poorest zip codes.”
She said there is a tendency to think this is a result of some sort of bias on the part of health care professionals. “We wanted to look deep down in the system and whether the built environment of health care supply and geographic distribution of services contributed to access and treatment inequities.”
The study combined a dataset of hospital stroke certification from all general acute nonfederal hospitals in the continental United States from January 2009 to December 2019. National, hospital, and census data were used to identify historically underserved communities by racial and ethnic composition, income distribution, and rurality.
A total of 4,984 hospitals were assessed. Results showed that over the 11-year study period, the number of hospitals with stroke certification grew from 961 (19%) to 1,763 (36%).
Without controlling for population and hospital size, hospitals in predominantly Black, racially segregated areas were 1.67-fold more likely to adopt stroke care of any level than those in predominantly non-Black, racially segregated areas (hazard ratio, 1.67; 95% confidence interval, 1.41-1.97).
However, after adjustment for population and hospital size, the likelihood of adopting stroke care among hospitals serving Black, racially segregated communities was significantly lower than among those serving non-Black, racially segregated communities (HR, 0.74; 95% CI, 0.62-0.89).
“In other words, on a per-capita basis, a hospital serving a predominantly Black, racially segregated community was 26% less likely to adopt stroke certification of any level than a hospital in a predominantly non-Black, racially segregated community,” the authors state.
In terms of socioeconomic factors, hospitals serving low-income, economically integrated (HR, 0.23) and low-income, economically segregated (HR, 0.29) areas were far less likely to adopt any level of stroke care certification than hospitals serving high-income areas, regardless of income segregation.
Rural hospitals were also much less likely to adopt any level of stroke care than urban hospitals (HR, 0.10).
“Our results suggest that it might be necessary to incentivize hospitals operating in underserved communities to seek stroke certification or to entice hospitals with higher propensity to adopt stroke care to operate in such communities so access at the per-patient level becomes more equitable,” the authors say.
This project was supported by the Pilot Project Award from the National Bureau of Economic Research Center for Aging and Health Research, funded by the National Institute on Aging and by the National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Shen and Dr. Hsia have received grants from the National Institute of Aging and the National Heart, Lung, and Blood Institute.
A version of this article first appeared on Medscape.com.
Hospitals in low-income and rural areas of the United States are much less likely to adopt stroke certification than hospitals in high-income and urban communities, a new study shows.
Further, other results showed that, after adjustment for population and hospital size, access to stroke-certified hospitals is significantly lower in Black, racially segregated communities.
The study was published online in JAMA Neurology.
Noting that stroke-certified hospitals provide higher-quality stroke care, the authors, led by Yu-Chu Shen, PhD, Naval Postgraduate School, Monterey, Calif., conclude that: “Our findings suggest that structural inequities in stroke care may be an important consideration in eliminating stroke disparities for vulnerable populations.”
In an audio interview on the JAMA Neurology website, senior author Renee Y. Hsia, MD, University of California, San Francisco, said: “Our findings show there are clear disparities in which communities are getting access to stroke certified hospitals.”
She called for more help for hospitals in underserved areas to obtain stroke certification.
Dr. Hsia explained that hospitals can seek certification at their own expense and that although stroke care is expensive, it is also lucrative in terms of reimbursement. So it tends to be the private for-profit hospitals that seek these certifications. “If you are a county hospital on a really tight budget, you’re not going to have the extra cash on hand to be applying for stroke certification,” she commented.
This can result in an increase in hospitals with stroke certification – but not in the areas that need it the most.
Dr. Hsia points out that this has happened in cardiac care. One study showed a 44% increase in hospitals providing percutaneous coronary intervention over a 10-year period, but the percentage of the population that had better access increased by less than 1%.
“In general, in the United States we have a mentality that ‘more is better,’ and because there is no government regulation in health care, any time a hospital applies for these specialized services we just generally think that’s a good thing. But this might not always be the case,” Dr. Hsia noted. “We have a very market-based approach, and this doesn’t lead to equity. It leads to profit maximization, and that is not synonymous with what’s good for patients or populations.”
She suggested that in future the process of certification should include some consideration of how it will affect population-based equity.
“Rather than rubber stamping an application just because hospitals have certain resources, we need to ask what the benefit is of providing this service,” Dr. Hsia said. “Does this community really need it? If not, maybe we should invest these resources into helping a hospital in a community that needs it more.”
Dr. Hsia explained that she and her colleagues conducted their study to investigate whether there were structural issues that might be contributing to disparities in stroke care.
“We like to think emergency stroke care is equitable. Anyone can call 911 or go the emergency room. But, actually, there is a big disparity on who receives what type of care,” she said. “We know Black patients are less likely to receive thrombolytics and mechanical thrombectomy compared to White patents. And wealthy patients are more likely to receive thrombectomy compared to patients from the poorest zip codes.”
She said there is a tendency to think this is a result of some sort of bias on the part of health care professionals. “We wanted to look deep down in the system and whether the built environment of health care supply and geographic distribution of services contributed to access and treatment inequities.”
The study combined a dataset of hospital stroke certification from all general acute nonfederal hospitals in the continental United States from January 2009 to December 2019. National, hospital, and census data were used to identify historically underserved communities by racial and ethnic composition, income distribution, and rurality.
A total of 4,984 hospitals were assessed. Results showed that over the 11-year study period, the number of hospitals with stroke certification grew from 961 (19%) to 1,763 (36%).
Without controlling for population and hospital size, hospitals in predominantly Black, racially segregated areas were 1.67-fold more likely to adopt stroke care of any level than those in predominantly non-Black, racially segregated areas (hazard ratio, 1.67; 95% confidence interval, 1.41-1.97).
However, after adjustment for population and hospital size, the likelihood of adopting stroke care among hospitals serving Black, racially segregated communities was significantly lower than among those serving non-Black, racially segregated communities (HR, 0.74; 95% CI, 0.62-0.89).
“In other words, on a per-capita basis, a hospital serving a predominantly Black, racially segregated community was 26% less likely to adopt stroke certification of any level than a hospital in a predominantly non-Black, racially segregated community,” the authors state.
In terms of socioeconomic factors, hospitals serving low-income, economically integrated (HR, 0.23) and low-income, economically segregated (HR, 0.29) areas were far less likely to adopt any level of stroke care certification than hospitals serving high-income areas, regardless of income segregation.
Rural hospitals were also much less likely to adopt any level of stroke care than urban hospitals (HR, 0.10).
“Our results suggest that it might be necessary to incentivize hospitals operating in underserved communities to seek stroke certification or to entice hospitals with higher propensity to adopt stroke care to operate in such communities so access at the per-patient level becomes more equitable,” the authors say.
This project was supported by the Pilot Project Award from the National Bureau of Economic Research Center for Aging and Health Research, funded by the National Institute on Aging and by the National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Shen and Dr. Hsia have received grants from the National Institute of Aging and the National Heart, Lung, and Blood Institute.
A version of this article first appeared on Medscape.com.
Hospitals in low-income and rural areas of the United States are much less likely to adopt stroke certification than hospitals in high-income and urban communities, a new study shows.
Further, other results showed that, after adjustment for population and hospital size, access to stroke-certified hospitals is significantly lower in Black, racially segregated communities.
The study was published online in JAMA Neurology.
Noting that stroke-certified hospitals provide higher-quality stroke care, the authors, led by Yu-Chu Shen, PhD, Naval Postgraduate School, Monterey, Calif., conclude that: “Our findings suggest that structural inequities in stroke care may be an important consideration in eliminating stroke disparities for vulnerable populations.”
In an audio interview on the JAMA Neurology website, senior author Renee Y. Hsia, MD, University of California, San Francisco, said: “Our findings show there are clear disparities in which communities are getting access to stroke certified hospitals.”
She called for more help for hospitals in underserved areas to obtain stroke certification.
Dr. Hsia explained that hospitals can seek certification at their own expense and that although stroke care is expensive, it is also lucrative in terms of reimbursement. So it tends to be the private for-profit hospitals that seek these certifications. “If you are a county hospital on a really tight budget, you’re not going to have the extra cash on hand to be applying for stroke certification,” she commented.
This can result in an increase in hospitals with stroke certification – but not in the areas that need it the most.
Dr. Hsia points out that this has happened in cardiac care. One study showed a 44% increase in hospitals providing percutaneous coronary intervention over a 10-year period, but the percentage of the population that had better access increased by less than 1%.
“In general, in the United States we have a mentality that ‘more is better,’ and because there is no government regulation in health care, any time a hospital applies for these specialized services we just generally think that’s a good thing. But this might not always be the case,” Dr. Hsia noted. “We have a very market-based approach, and this doesn’t lead to equity. It leads to profit maximization, and that is not synonymous with what’s good for patients or populations.”
She suggested that in future the process of certification should include some consideration of how it will affect population-based equity.
“Rather than rubber stamping an application just because hospitals have certain resources, we need to ask what the benefit is of providing this service,” Dr. Hsia said. “Does this community really need it? If not, maybe we should invest these resources into helping a hospital in a community that needs it more.”
Dr. Hsia explained that she and her colleagues conducted their study to investigate whether there were structural issues that might be contributing to disparities in stroke care.
“We like to think emergency stroke care is equitable. Anyone can call 911 or go the emergency room. But, actually, there is a big disparity on who receives what type of care,” she said. “We know Black patients are less likely to receive thrombolytics and mechanical thrombectomy compared to White patents. And wealthy patients are more likely to receive thrombectomy compared to patients from the poorest zip codes.”
She said there is a tendency to think this is a result of some sort of bias on the part of health care professionals. “We wanted to look deep down in the system and whether the built environment of health care supply and geographic distribution of services contributed to access and treatment inequities.”
The study combined a dataset of hospital stroke certification from all general acute nonfederal hospitals in the continental United States from January 2009 to December 2019. National, hospital, and census data were used to identify historically underserved communities by racial and ethnic composition, income distribution, and rurality.
A total of 4,984 hospitals were assessed. Results showed that over the 11-year study period, the number of hospitals with stroke certification grew from 961 (19%) to 1,763 (36%).
Without controlling for population and hospital size, hospitals in predominantly Black, racially segregated areas were 1.67-fold more likely to adopt stroke care of any level than those in predominantly non-Black, racially segregated areas (hazard ratio, 1.67; 95% confidence interval, 1.41-1.97).
However, after adjustment for population and hospital size, the likelihood of adopting stroke care among hospitals serving Black, racially segregated communities was significantly lower than among those serving non-Black, racially segregated communities (HR, 0.74; 95% CI, 0.62-0.89).
“In other words, on a per-capita basis, a hospital serving a predominantly Black, racially segregated community was 26% less likely to adopt stroke certification of any level than a hospital in a predominantly non-Black, racially segregated community,” the authors state.
In terms of socioeconomic factors, hospitals serving low-income, economically integrated (HR, 0.23) and low-income, economically segregated (HR, 0.29) areas were far less likely to adopt any level of stroke care certification than hospitals serving high-income areas, regardless of income segregation.
Rural hospitals were also much less likely to adopt any level of stroke care than urban hospitals (HR, 0.10).
“Our results suggest that it might be necessary to incentivize hospitals operating in underserved communities to seek stroke certification or to entice hospitals with higher propensity to adopt stroke care to operate in such communities so access at the per-patient level becomes more equitable,” the authors say.
This project was supported by the Pilot Project Award from the National Bureau of Economic Research Center for Aging and Health Research, funded by the National Institute on Aging and by the National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Shen and Dr. Hsia have received grants from the National Institute of Aging and the National Heart, Lung, and Blood Institute.
A version of this article first appeared on Medscape.com.
Cardiologists concerned for patient safety after abortion ruling
Pregnancy termination for medical reasons had been part of the fabric of everyday health care in the United States since the Supreme Court’s 1973 Roe v. Wade decision, which the current high court overturned in a ruling announced on June 24.
That means many clinicians across specialties are entering uncharted territory with the country’s new patchwork of abortion legality. Some specialties, cardiology among them, may feel the impact more than others.
“We know that the rising maternal mortality rate is predominantly driven by cardiovascular disease, women having children at older ages, and ... risk factors like hypertension, diabetes, and obesity,” Jennifer H. Haythe, MD, told this news organization.
So the high court’s decision in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade and leaves the legality of abortion up to the 50 separate state legislatures, “is very relevant to cardiologists specifically,” said Dr. Haythe, who is director of cardiology in the cardio-obstetrics program at New York-Presbyterian/Columbia University Irving Medical Center, New York.
The ruling “is going to have a huge effect on women who may not be able to tolerate pregnancy,” she said. Whether to terminate a pregnancy “is a relatively common discussion I have with women with bad heart failure about their risk of further decompensation, death, or needing a heart transplant or heart pump after delivery, or the risk of death in women with pulmonary hypertension.”
The high court’s decision “is a direct attack on the practice of medicine and really the sanctity of the patient-clinician relationship,” Rachel M. Bond, MD, director of Women’s Heart Health Systems Dignity Health of Arizona, told this news organization.
Physicians take an oath “that we should do no harm to our patients, and once the law or governance impacts that, it places us in a very vulnerable situation,” Dr. Bond said. “As a cardiologist who focuses a lot on high-risk pregnancies, I am worried and hesitant to give guidance to many of these patients in the states that may not have access to something that is a medical right, which at times is an abortion.”
She has colleagues in obstetrics in states where abortion is newly illegal who “don’t know what to do,” Dr. Bond said. Many have sought guidance from their legal teams, she said, “and many of them are now trying to figure out what is the best path.”
Pregnancy is “a very significant cardiovascular stress test, and women who may tolerate certain conditions reasonably well outside of the setting of pregnancy may have severe issues, not just for the mother, but for the baby as well,” Ki Park, MD, University of Florida Health, Gainesville, said in an interview.
“As clinicians, none of us like recommending a medically indicated abortion. But it is health care, just like any other medication or treatment that we advise to our patients in cases where the risk of the mother is excessively high and mortality risk is elevated,” said Dr. Park, who is cochair of the American College of Cardiology Cardio-Obstetrics Work Group.
Some conditions, such as pulmonary hypertension and severe aortic valve stenosis, during pregnancy are well recognized as very high risk, and there are various scoring systems to help clinicians with risk stratification, she observed. “But there are also a lot of gray areas where patients don’t necessarily fit into these risk scores that we use.”
So physician-patient discussions in high-risk pregnancies “are already complicated,” Dr. Park said. “Patients want to have options, and they look to us as physicians for guidance with regard to their risks. And if abortion is not available as an option, then part of our toolbox is no longer available to help us care for the mother.”
In the new legal climate, clinicians in states where abortion is illegal may well want to put more emphasis on preconception counseling, so more of their patients with high-risk conditions are aware of the new barriers to pregnancy termination.
“Unfortunately,” Dr. Haythe said, “many of the states that are going to make or have made abortion illegal are not providing that kind of preconception counseling or good prenatal care to women.”
Cardiologists can provide such counseling to their female patients of childbearing age who have high-risk cardiac conditions, “but not everybody knows that they have a heart problem when they get pregnant, and not everybody is getting screened for heart problems when they’re of childbearing age,” Dr. Haythe said.
“Sometimes it’s not clear whether the problems could have been picked up until a woman is pregnant and has started to have symptoms.” For example, “a lot of women with poor access to health care have rheumatic heart disease. They may have no idea that they have severe aortic stenosis, and it’s not until their second trimester that they start to feel really short of breath.” Often that can be treated in the cath lab, “but again, that’s putting the woman and the baby at risk.”
Cardiologists in states where abortion is illegal will still present the option to their patients with high-risk pregnancies, noted Dr. Haythe. But the conversation may sound something like, “you are at very high risk, termination of the pregnancy takes that risk away, but you’ll have to find a state where it’s legal to do that.”
Dr. Park said such a situation, when abortion is recommended but locally unavailable, is much like any other in cardiology for which the patient may want a second opinion. If a center “doesn’t have the capability or the technology to offer a certain treatment, the patient can opt to seek another opinion at another center,” she said. “Patients will often travel out of state to get the care they need.”
A requirement for out-of-state travel to obtain abortions is likely to worsen socioeconomic disparities in health care, Dr. Bond observed, “because we know that those who are low-income won’t be able to afford that travel.”
Dr. Bond is cosignatory on a statement from the Association of Black Cardiologists (ABC) responding to the high court’s ruling in Dobbs v. Jackson. “This decision will isolate the poor, socioeconomically disadvantaged, and minority populations specifically, widening the already large gaps in health care for our most vulnerable communities,” it states.
“The loss of broad protections supporting the medical and often lifesaving procedure of abortions is likely to have a real impact on the maternal mortality rate, especially in those with congenital and/or acquired cardiovascular conditions where evidence-based guidelines advise at times on termination of such high-risk pregnancies.”
The ABC, it states, “believes that every woman, and every person, should be afforded the right to safe, accessible, legal, timely, patient-centered, equitable, and affordable health care.”
The American College of Cardiology (ACC) released a statement on the matter June 24, signed by its president, Edward T.A. Fry, MD, along with five former ACC presidents. “While the ACC has no official policy on abortion, clinical practice guidelines and other clinical guidance tools address the dangers of pregnancy in certain patient populations at higher risk of death or serious cardiac events.”
The college, it states, is “deeply concerned about the potential implications of the Supreme Court decision regarding Roe vs. Wade on the ability of patients and clinicians to engage in important shared discussions about maternal health, or to remove previously available health care options.”
Dr. Bond proposed that a “vocal stance” from medical societies involved in women’s health, “perhaps even a collective stance from our cardiovascular societies and our obstetrics societies,” would also perhaps reach “the masses of doctors in private practice who are dealing with these patients.”
A version of this article first appeared on Medscape.com.
Pregnancy termination for medical reasons had been part of the fabric of everyday health care in the United States since the Supreme Court’s 1973 Roe v. Wade decision, which the current high court overturned in a ruling announced on June 24.
That means many clinicians across specialties are entering uncharted territory with the country’s new patchwork of abortion legality. Some specialties, cardiology among them, may feel the impact more than others.
“We know that the rising maternal mortality rate is predominantly driven by cardiovascular disease, women having children at older ages, and ... risk factors like hypertension, diabetes, and obesity,” Jennifer H. Haythe, MD, told this news organization.
So the high court’s decision in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade and leaves the legality of abortion up to the 50 separate state legislatures, “is very relevant to cardiologists specifically,” said Dr. Haythe, who is director of cardiology in the cardio-obstetrics program at New York-Presbyterian/Columbia University Irving Medical Center, New York.
The ruling “is going to have a huge effect on women who may not be able to tolerate pregnancy,” she said. Whether to terminate a pregnancy “is a relatively common discussion I have with women with bad heart failure about their risk of further decompensation, death, or needing a heart transplant or heart pump after delivery, or the risk of death in women with pulmonary hypertension.”
The high court’s decision “is a direct attack on the practice of medicine and really the sanctity of the patient-clinician relationship,” Rachel M. Bond, MD, director of Women’s Heart Health Systems Dignity Health of Arizona, told this news organization.
Physicians take an oath “that we should do no harm to our patients, and once the law or governance impacts that, it places us in a very vulnerable situation,” Dr. Bond said. “As a cardiologist who focuses a lot on high-risk pregnancies, I am worried and hesitant to give guidance to many of these patients in the states that may not have access to something that is a medical right, which at times is an abortion.”
She has colleagues in obstetrics in states where abortion is newly illegal who “don’t know what to do,” Dr. Bond said. Many have sought guidance from their legal teams, she said, “and many of them are now trying to figure out what is the best path.”
Pregnancy is “a very significant cardiovascular stress test, and women who may tolerate certain conditions reasonably well outside of the setting of pregnancy may have severe issues, not just for the mother, but for the baby as well,” Ki Park, MD, University of Florida Health, Gainesville, said in an interview.
“As clinicians, none of us like recommending a medically indicated abortion. But it is health care, just like any other medication or treatment that we advise to our patients in cases where the risk of the mother is excessively high and mortality risk is elevated,” said Dr. Park, who is cochair of the American College of Cardiology Cardio-Obstetrics Work Group.
Some conditions, such as pulmonary hypertension and severe aortic valve stenosis, during pregnancy are well recognized as very high risk, and there are various scoring systems to help clinicians with risk stratification, she observed. “But there are also a lot of gray areas where patients don’t necessarily fit into these risk scores that we use.”
So physician-patient discussions in high-risk pregnancies “are already complicated,” Dr. Park said. “Patients want to have options, and they look to us as physicians for guidance with regard to their risks. And if abortion is not available as an option, then part of our toolbox is no longer available to help us care for the mother.”
In the new legal climate, clinicians in states where abortion is illegal may well want to put more emphasis on preconception counseling, so more of their patients with high-risk conditions are aware of the new barriers to pregnancy termination.
“Unfortunately,” Dr. Haythe said, “many of the states that are going to make or have made abortion illegal are not providing that kind of preconception counseling or good prenatal care to women.”
Cardiologists can provide such counseling to their female patients of childbearing age who have high-risk cardiac conditions, “but not everybody knows that they have a heart problem when they get pregnant, and not everybody is getting screened for heart problems when they’re of childbearing age,” Dr. Haythe said.
“Sometimes it’s not clear whether the problems could have been picked up until a woman is pregnant and has started to have symptoms.” For example, “a lot of women with poor access to health care have rheumatic heart disease. They may have no idea that they have severe aortic stenosis, and it’s not until their second trimester that they start to feel really short of breath.” Often that can be treated in the cath lab, “but again, that’s putting the woman and the baby at risk.”
Cardiologists in states where abortion is illegal will still present the option to their patients with high-risk pregnancies, noted Dr. Haythe. But the conversation may sound something like, “you are at very high risk, termination of the pregnancy takes that risk away, but you’ll have to find a state where it’s legal to do that.”
Dr. Park said such a situation, when abortion is recommended but locally unavailable, is much like any other in cardiology for which the patient may want a second opinion. If a center “doesn’t have the capability or the technology to offer a certain treatment, the patient can opt to seek another opinion at another center,” she said. “Patients will often travel out of state to get the care they need.”
A requirement for out-of-state travel to obtain abortions is likely to worsen socioeconomic disparities in health care, Dr. Bond observed, “because we know that those who are low-income won’t be able to afford that travel.”
Dr. Bond is cosignatory on a statement from the Association of Black Cardiologists (ABC) responding to the high court’s ruling in Dobbs v. Jackson. “This decision will isolate the poor, socioeconomically disadvantaged, and minority populations specifically, widening the already large gaps in health care for our most vulnerable communities,” it states.
“The loss of broad protections supporting the medical and often lifesaving procedure of abortions is likely to have a real impact on the maternal mortality rate, especially in those with congenital and/or acquired cardiovascular conditions where evidence-based guidelines advise at times on termination of such high-risk pregnancies.”
The ABC, it states, “believes that every woman, and every person, should be afforded the right to safe, accessible, legal, timely, patient-centered, equitable, and affordable health care.”
The American College of Cardiology (ACC) released a statement on the matter June 24, signed by its president, Edward T.A. Fry, MD, along with five former ACC presidents. “While the ACC has no official policy on abortion, clinical practice guidelines and other clinical guidance tools address the dangers of pregnancy in certain patient populations at higher risk of death or serious cardiac events.”
The college, it states, is “deeply concerned about the potential implications of the Supreme Court decision regarding Roe vs. Wade on the ability of patients and clinicians to engage in important shared discussions about maternal health, or to remove previously available health care options.”
Dr. Bond proposed that a “vocal stance” from medical societies involved in women’s health, “perhaps even a collective stance from our cardiovascular societies and our obstetrics societies,” would also perhaps reach “the masses of doctors in private practice who are dealing with these patients.”
A version of this article first appeared on Medscape.com.
Pregnancy termination for medical reasons had been part of the fabric of everyday health care in the United States since the Supreme Court’s 1973 Roe v. Wade decision, which the current high court overturned in a ruling announced on June 24.
That means many clinicians across specialties are entering uncharted territory with the country’s new patchwork of abortion legality. Some specialties, cardiology among them, may feel the impact more than others.
“We know that the rising maternal mortality rate is predominantly driven by cardiovascular disease, women having children at older ages, and ... risk factors like hypertension, diabetes, and obesity,” Jennifer H. Haythe, MD, told this news organization.
So the high court’s decision in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade and leaves the legality of abortion up to the 50 separate state legislatures, “is very relevant to cardiologists specifically,” said Dr. Haythe, who is director of cardiology in the cardio-obstetrics program at New York-Presbyterian/Columbia University Irving Medical Center, New York.
The ruling “is going to have a huge effect on women who may not be able to tolerate pregnancy,” she said. Whether to terminate a pregnancy “is a relatively common discussion I have with women with bad heart failure about their risk of further decompensation, death, or needing a heart transplant or heart pump after delivery, or the risk of death in women with pulmonary hypertension.”
The high court’s decision “is a direct attack on the practice of medicine and really the sanctity of the patient-clinician relationship,” Rachel M. Bond, MD, director of Women’s Heart Health Systems Dignity Health of Arizona, told this news organization.
Physicians take an oath “that we should do no harm to our patients, and once the law or governance impacts that, it places us in a very vulnerable situation,” Dr. Bond said. “As a cardiologist who focuses a lot on high-risk pregnancies, I am worried and hesitant to give guidance to many of these patients in the states that may not have access to something that is a medical right, which at times is an abortion.”
She has colleagues in obstetrics in states where abortion is newly illegal who “don’t know what to do,” Dr. Bond said. Many have sought guidance from their legal teams, she said, “and many of them are now trying to figure out what is the best path.”
Pregnancy is “a very significant cardiovascular stress test, and women who may tolerate certain conditions reasonably well outside of the setting of pregnancy may have severe issues, not just for the mother, but for the baby as well,” Ki Park, MD, University of Florida Health, Gainesville, said in an interview.
“As clinicians, none of us like recommending a medically indicated abortion. But it is health care, just like any other medication or treatment that we advise to our patients in cases where the risk of the mother is excessively high and mortality risk is elevated,” said Dr. Park, who is cochair of the American College of Cardiology Cardio-Obstetrics Work Group.
Some conditions, such as pulmonary hypertension and severe aortic valve stenosis, during pregnancy are well recognized as very high risk, and there are various scoring systems to help clinicians with risk stratification, she observed. “But there are also a lot of gray areas where patients don’t necessarily fit into these risk scores that we use.”
So physician-patient discussions in high-risk pregnancies “are already complicated,” Dr. Park said. “Patients want to have options, and they look to us as physicians for guidance with regard to their risks. And if abortion is not available as an option, then part of our toolbox is no longer available to help us care for the mother.”
In the new legal climate, clinicians in states where abortion is illegal may well want to put more emphasis on preconception counseling, so more of their patients with high-risk conditions are aware of the new barriers to pregnancy termination.
“Unfortunately,” Dr. Haythe said, “many of the states that are going to make or have made abortion illegal are not providing that kind of preconception counseling or good prenatal care to women.”
Cardiologists can provide such counseling to their female patients of childbearing age who have high-risk cardiac conditions, “but not everybody knows that they have a heart problem when they get pregnant, and not everybody is getting screened for heart problems when they’re of childbearing age,” Dr. Haythe said.
“Sometimes it’s not clear whether the problems could have been picked up until a woman is pregnant and has started to have symptoms.” For example, “a lot of women with poor access to health care have rheumatic heart disease. They may have no idea that they have severe aortic stenosis, and it’s not until their second trimester that they start to feel really short of breath.” Often that can be treated in the cath lab, “but again, that’s putting the woman and the baby at risk.”
Cardiologists in states where abortion is illegal will still present the option to their patients with high-risk pregnancies, noted Dr. Haythe. But the conversation may sound something like, “you are at very high risk, termination of the pregnancy takes that risk away, but you’ll have to find a state where it’s legal to do that.”
Dr. Park said such a situation, when abortion is recommended but locally unavailable, is much like any other in cardiology for which the patient may want a second opinion. If a center “doesn’t have the capability or the technology to offer a certain treatment, the patient can opt to seek another opinion at another center,” she said. “Patients will often travel out of state to get the care they need.”
A requirement for out-of-state travel to obtain abortions is likely to worsen socioeconomic disparities in health care, Dr. Bond observed, “because we know that those who are low-income won’t be able to afford that travel.”
Dr. Bond is cosignatory on a statement from the Association of Black Cardiologists (ABC) responding to the high court’s ruling in Dobbs v. Jackson. “This decision will isolate the poor, socioeconomically disadvantaged, and minority populations specifically, widening the already large gaps in health care for our most vulnerable communities,” it states.
“The loss of broad protections supporting the medical and often lifesaving procedure of abortions is likely to have a real impact on the maternal mortality rate, especially in those with congenital and/or acquired cardiovascular conditions where evidence-based guidelines advise at times on termination of such high-risk pregnancies.”
The ABC, it states, “believes that every woman, and every person, should be afforded the right to safe, accessible, legal, timely, patient-centered, equitable, and affordable health care.”
The American College of Cardiology (ACC) released a statement on the matter June 24, signed by its president, Edward T.A. Fry, MD, along with five former ACC presidents. “While the ACC has no official policy on abortion, clinical practice guidelines and other clinical guidance tools address the dangers of pregnancy in certain patient populations at higher risk of death or serious cardiac events.”
The college, it states, is “deeply concerned about the potential implications of the Supreme Court decision regarding Roe vs. Wade on the ability of patients and clinicians to engage in important shared discussions about maternal health, or to remove previously available health care options.”
Dr. Bond proposed that a “vocal stance” from medical societies involved in women’s health, “perhaps even a collective stance from our cardiovascular societies and our obstetrics societies,” would also perhaps reach “the masses of doctors in private practice who are dealing with these patients.”
A version of this article first appeared on Medscape.com.
Stroke risk rises for women with history of infertility, miscarriage, stillbirth
Infertility, pregnancy loss, and stillbirth increased women’s later risk of both nonfatal and fatal stroke, based on data from more than 600,000 women.
“To date, multiple studies have generated an expanding body of evidence on the association between pregnancy complications (e.g., gestational diabetes and preeclampsia) and the long-term risk of stroke, but studies on associations with infertility, miscarriage, or stillbirth have produced mixed evidence,” Chen Liang, a PhD candidate at the University of Queensland, Brisbane, Australia, and colleagues wrote.
In a study published in the BMJ, the researchers reviewed data from eight observational cohort studies across seven countries (Australia, China, Japan, the Netherlands, Sweden, the United Kingdom, and the United States). The participants were part of the InterLACE (International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events) consortium established in 2021. Most observational studies included in the analysis began between 1990 and 2000.
The study population included 618,851 women aged 32-73 years at baseline for whom data on infertility, miscarriage, or stillbirth, were available. The primary outcome was the association of infertility, recurrent miscarriage, and stillbirth with risk of first fatal or nonfatal stroke, and the results were further stratified by subtype. Stroke was identified through self-reports, linked hospital data, national patient registers, or death registry data. Baseline was defined as the first incidence of infertility, miscarriage, or stillbirth. The exception was the National Survey of Health and Development, a British birth cohort started in 1946, that collected data retrospectively.
The median follow-up period was 13 years for nonfatal stroke and 9.4 years for fatal stroke.
Overall, 17.2%, 16.6%, and 4.6% of the women experienced infertility, miscarriage, and stillbirth, respectively.
Women with a history of infertility had a significantly higher nonfatal stroke risk, compared with those without infertility (hazard ratio, 1.14). Further analysis by stroke subtypes showed an increased association between miscarriage and ischemic stroke (HR, 1.15).
Those with a history of miscarriage also had an increased risk of nonfatal stroke, compared with those without miscarriages (HR, 1.11). In the miscarriage group, the risk of stroke increased with the number of miscarriages, with adjusted HRs of 1.07, 1.12, and 1.35 for women with one, two, and three or more miscarriages, respectively. When stratified by stroke subtype, women with three or more miscarriages were more likely than women with no miscarriages to experience ischemic and hemorrhagic nonfatal strokes.
Associations were similar between miscarriage history and fatal stroke risk. Women with one, two, and three or more miscarriages had increased risk of fatal stroke, compared with those with no miscarriages (aHR, 1.08, 1.26, and 1.82, respectively, and women with three or more miscarriages had a higher risk of ischemic and hemorrhagic stroke (aHR, 1.83 and 1.84, respectively).
Women with a history of stillbirth had an approximately 31% increased risk of nonfatal stroke, compared with those with no history of stillbirth, with aHRs similar for single and recurrent stillbirths (1.32 and 1.29, respectively). Ischemic nonfatal stroke risk was higher in women with any stillbirth, compared with those without stillbirth (aHR, 1.77). Fatal stroke risk also was higher in women with any stillbirth, compared with those without, and this risk increased with the number of stillbirths (HR, 0.97 and HR, 1.26 for those with one stillbirth and two or more, respectively).
“The increased risk of stroke associated with infertility or recurrent stillbirths was mainly driven by a single subtype of stroke (nonfatal ischemic stroke or fatal hemorrhagic stroke, respectively), whereas the risk of stroke associated with recurrent miscarriages was driven by both subtypes,” the researchers wrote.
The researchers cited endothelial dysfunction as a potential underlying mechanism for increased stroke risk associated with pregnancy complications. “Endothelial dysfunction might lead to pregnancy loss through placentation-related defects, persist after a complicated pregnancy, and contribute to the development of stroke through reduced vasodilation, proinflammatory status, and prothrombic properties,” and that history of recurrent pregnancy loss might be a female-specific risk factor for stroke.
To mitigate this risk, they advised early monitoring of women with a history of recurrent miscarriages and stillbirths for stroke risk factors such as high blood pressure, blood sugar levels, and lipid levels.
The study findings were limited by several factors including the use of questionnaires to collect information on infertility, miscarriage, and stillbirth, and the potential variation in definitions of infertility, miscarriage, and stillbirth across the included studies, and a lack of data on the effect of different causes or treatments based on reproductive histories, the researchers noted. Other limitations include incomplete data on stroke subtypes and inability to adjust for all covariates such as thyroid disorders and endometriosis. However, the results were strengthened by the large study size and geographically and racially diverse population, extend the current knowledge on associations between infertility, miscarriage, and stillbirth with stroke, and highlight the need for more research on underlying mechanisms.
Data support gender-specific stroke risk stratification
“Studies that seek to understand gender differences and disparities in adverse outcomes, such as stroke risk, are extremely important given that women historically were excluded from research studies,” Catherine M. Albright, MD, of the University of Washington, Seattle, said in an interview. “By doing these studies, we are able to better risk stratify people in order to better predict and modify risks,” added Dr. Albright, who was not involved in the current study.
“It is well known than adverse pregnancy outcomes such as hypertension in pregnancy, fetal growth restriction, and preterm birth, lead to increased risk of cardiovascular disease and stroke later in life, so the general findings of an association between other adverse reproductive and pregnancy outcomes leads to increased stroke risk are not surprising,” she said.
“The take-home message is that outcomes for pregnancy really do provide a window to future health,” said Dr. Albright. “For clinicians, especially non-ob.gyns., knowing a complete pregnancy history for any new patient is important and can help risk-stratify patients, especially as we continue to gain knowledge like what is shown in this study.”
However, “this study did not evaluate why individual patients may have had infertility, recurrent pregnancy loss, or stillbirth, so research to look further into this association to determine if there is an underlying medical condition that could be treated and therefore possibly reduce both pregnancy complications and future stroke risks would be important,” Dr. Albright noted.
The study was supported by the Australian National Health and Medical Research Council Centres of Research Excellence; one corresponding author was supported by an Australian National Health and Medical Research Council Investigator grant. The researchers had no financial conflicts to disclose. Dr. Albright had no financial conflicts to disclose.
Infertility, pregnancy loss, and stillbirth increased women’s later risk of both nonfatal and fatal stroke, based on data from more than 600,000 women.
“To date, multiple studies have generated an expanding body of evidence on the association between pregnancy complications (e.g., gestational diabetes and preeclampsia) and the long-term risk of stroke, but studies on associations with infertility, miscarriage, or stillbirth have produced mixed evidence,” Chen Liang, a PhD candidate at the University of Queensland, Brisbane, Australia, and colleagues wrote.
In a study published in the BMJ, the researchers reviewed data from eight observational cohort studies across seven countries (Australia, China, Japan, the Netherlands, Sweden, the United Kingdom, and the United States). The participants were part of the InterLACE (International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events) consortium established in 2021. Most observational studies included in the analysis began between 1990 and 2000.
The study population included 618,851 women aged 32-73 years at baseline for whom data on infertility, miscarriage, or stillbirth, were available. The primary outcome was the association of infertility, recurrent miscarriage, and stillbirth with risk of first fatal or nonfatal stroke, and the results were further stratified by subtype. Stroke was identified through self-reports, linked hospital data, national patient registers, or death registry data. Baseline was defined as the first incidence of infertility, miscarriage, or stillbirth. The exception was the National Survey of Health and Development, a British birth cohort started in 1946, that collected data retrospectively.
The median follow-up period was 13 years for nonfatal stroke and 9.4 years for fatal stroke.
Overall, 17.2%, 16.6%, and 4.6% of the women experienced infertility, miscarriage, and stillbirth, respectively.
Women with a history of infertility had a significantly higher nonfatal stroke risk, compared with those without infertility (hazard ratio, 1.14). Further analysis by stroke subtypes showed an increased association between miscarriage and ischemic stroke (HR, 1.15).
Those with a history of miscarriage also had an increased risk of nonfatal stroke, compared with those without miscarriages (HR, 1.11). In the miscarriage group, the risk of stroke increased with the number of miscarriages, with adjusted HRs of 1.07, 1.12, and 1.35 for women with one, two, and three or more miscarriages, respectively. When stratified by stroke subtype, women with three or more miscarriages were more likely than women with no miscarriages to experience ischemic and hemorrhagic nonfatal strokes.
Associations were similar between miscarriage history and fatal stroke risk. Women with one, two, and three or more miscarriages had increased risk of fatal stroke, compared with those with no miscarriages (aHR, 1.08, 1.26, and 1.82, respectively, and women with three or more miscarriages had a higher risk of ischemic and hemorrhagic stroke (aHR, 1.83 and 1.84, respectively).
Women with a history of stillbirth had an approximately 31% increased risk of nonfatal stroke, compared with those with no history of stillbirth, with aHRs similar for single and recurrent stillbirths (1.32 and 1.29, respectively). Ischemic nonfatal stroke risk was higher in women with any stillbirth, compared with those without stillbirth (aHR, 1.77). Fatal stroke risk also was higher in women with any stillbirth, compared with those without, and this risk increased with the number of stillbirths (HR, 0.97 and HR, 1.26 for those with one stillbirth and two or more, respectively).
“The increased risk of stroke associated with infertility or recurrent stillbirths was mainly driven by a single subtype of stroke (nonfatal ischemic stroke or fatal hemorrhagic stroke, respectively), whereas the risk of stroke associated with recurrent miscarriages was driven by both subtypes,” the researchers wrote.
The researchers cited endothelial dysfunction as a potential underlying mechanism for increased stroke risk associated with pregnancy complications. “Endothelial dysfunction might lead to pregnancy loss through placentation-related defects, persist after a complicated pregnancy, and contribute to the development of stroke through reduced vasodilation, proinflammatory status, and prothrombic properties,” and that history of recurrent pregnancy loss might be a female-specific risk factor for stroke.
To mitigate this risk, they advised early monitoring of women with a history of recurrent miscarriages and stillbirths for stroke risk factors such as high blood pressure, blood sugar levels, and lipid levels.
The study findings were limited by several factors including the use of questionnaires to collect information on infertility, miscarriage, and stillbirth, and the potential variation in definitions of infertility, miscarriage, and stillbirth across the included studies, and a lack of data on the effect of different causes or treatments based on reproductive histories, the researchers noted. Other limitations include incomplete data on stroke subtypes and inability to adjust for all covariates such as thyroid disorders and endometriosis. However, the results were strengthened by the large study size and geographically and racially diverse population, extend the current knowledge on associations between infertility, miscarriage, and stillbirth with stroke, and highlight the need for more research on underlying mechanisms.
Data support gender-specific stroke risk stratification
“Studies that seek to understand gender differences and disparities in adverse outcomes, such as stroke risk, are extremely important given that women historically were excluded from research studies,” Catherine M. Albright, MD, of the University of Washington, Seattle, said in an interview. “By doing these studies, we are able to better risk stratify people in order to better predict and modify risks,” added Dr. Albright, who was not involved in the current study.
“It is well known than adverse pregnancy outcomes such as hypertension in pregnancy, fetal growth restriction, and preterm birth, lead to increased risk of cardiovascular disease and stroke later in life, so the general findings of an association between other adverse reproductive and pregnancy outcomes leads to increased stroke risk are not surprising,” she said.
“The take-home message is that outcomes for pregnancy really do provide a window to future health,” said Dr. Albright. “For clinicians, especially non-ob.gyns., knowing a complete pregnancy history for any new patient is important and can help risk-stratify patients, especially as we continue to gain knowledge like what is shown in this study.”
However, “this study did not evaluate why individual patients may have had infertility, recurrent pregnancy loss, or stillbirth, so research to look further into this association to determine if there is an underlying medical condition that could be treated and therefore possibly reduce both pregnancy complications and future stroke risks would be important,” Dr. Albright noted.
The study was supported by the Australian National Health and Medical Research Council Centres of Research Excellence; one corresponding author was supported by an Australian National Health and Medical Research Council Investigator grant. The researchers had no financial conflicts to disclose. Dr. Albright had no financial conflicts to disclose.
Infertility, pregnancy loss, and stillbirth increased women’s later risk of both nonfatal and fatal stroke, based on data from more than 600,000 women.
“To date, multiple studies have generated an expanding body of evidence on the association between pregnancy complications (e.g., gestational diabetes and preeclampsia) and the long-term risk of stroke, but studies on associations with infertility, miscarriage, or stillbirth have produced mixed evidence,” Chen Liang, a PhD candidate at the University of Queensland, Brisbane, Australia, and colleagues wrote.
In a study published in the BMJ, the researchers reviewed data from eight observational cohort studies across seven countries (Australia, China, Japan, the Netherlands, Sweden, the United Kingdom, and the United States). The participants were part of the InterLACE (International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events) consortium established in 2021. Most observational studies included in the analysis began between 1990 and 2000.
The study population included 618,851 women aged 32-73 years at baseline for whom data on infertility, miscarriage, or stillbirth, were available. The primary outcome was the association of infertility, recurrent miscarriage, and stillbirth with risk of first fatal or nonfatal stroke, and the results were further stratified by subtype. Stroke was identified through self-reports, linked hospital data, national patient registers, or death registry data. Baseline was defined as the first incidence of infertility, miscarriage, or stillbirth. The exception was the National Survey of Health and Development, a British birth cohort started in 1946, that collected data retrospectively.
The median follow-up period was 13 years for nonfatal stroke and 9.4 years for fatal stroke.
Overall, 17.2%, 16.6%, and 4.6% of the women experienced infertility, miscarriage, and stillbirth, respectively.
Women with a history of infertility had a significantly higher nonfatal stroke risk, compared with those without infertility (hazard ratio, 1.14). Further analysis by stroke subtypes showed an increased association between miscarriage and ischemic stroke (HR, 1.15).
Those with a history of miscarriage also had an increased risk of nonfatal stroke, compared with those without miscarriages (HR, 1.11). In the miscarriage group, the risk of stroke increased with the number of miscarriages, with adjusted HRs of 1.07, 1.12, and 1.35 for women with one, two, and three or more miscarriages, respectively. When stratified by stroke subtype, women with three or more miscarriages were more likely than women with no miscarriages to experience ischemic and hemorrhagic nonfatal strokes.
Associations were similar between miscarriage history and fatal stroke risk. Women with one, two, and three or more miscarriages had increased risk of fatal stroke, compared with those with no miscarriages (aHR, 1.08, 1.26, and 1.82, respectively, and women with three or more miscarriages had a higher risk of ischemic and hemorrhagic stroke (aHR, 1.83 and 1.84, respectively).
Women with a history of stillbirth had an approximately 31% increased risk of nonfatal stroke, compared with those with no history of stillbirth, with aHRs similar for single and recurrent stillbirths (1.32 and 1.29, respectively). Ischemic nonfatal stroke risk was higher in women with any stillbirth, compared with those without stillbirth (aHR, 1.77). Fatal stroke risk also was higher in women with any stillbirth, compared with those without, and this risk increased with the number of stillbirths (HR, 0.97 and HR, 1.26 for those with one stillbirth and two or more, respectively).
“The increased risk of stroke associated with infertility or recurrent stillbirths was mainly driven by a single subtype of stroke (nonfatal ischemic stroke or fatal hemorrhagic stroke, respectively), whereas the risk of stroke associated with recurrent miscarriages was driven by both subtypes,” the researchers wrote.
The researchers cited endothelial dysfunction as a potential underlying mechanism for increased stroke risk associated with pregnancy complications. “Endothelial dysfunction might lead to pregnancy loss through placentation-related defects, persist after a complicated pregnancy, and contribute to the development of stroke through reduced vasodilation, proinflammatory status, and prothrombic properties,” and that history of recurrent pregnancy loss might be a female-specific risk factor for stroke.
To mitigate this risk, they advised early monitoring of women with a history of recurrent miscarriages and stillbirths for stroke risk factors such as high blood pressure, blood sugar levels, and lipid levels.
The study findings were limited by several factors including the use of questionnaires to collect information on infertility, miscarriage, and stillbirth, and the potential variation in definitions of infertility, miscarriage, and stillbirth across the included studies, and a lack of data on the effect of different causes or treatments based on reproductive histories, the researchers noted. Other limitations include incomplete data on stroke subtypes and inability to adjust for all covariates such as thyroid disorders and endometriosis. However, the results were strengthened by the large study size and geographically and racially diverse population, extend the current knowledge on associations between infertility, miscarriage, and stillbirth with stroke, and highlight the need for more research on underlying mechanisms.
Data support gender-specific stroke risk stratification
“Studies that seek to understand gender differences and disparities in adverse outcomes, such as stroke risk, are extremely important given that women historically were excluded from research studies,” Catherine M. Albright, MD, of the University of Washington, Seattle, said in an interview. “By doing these studies, we are able to better risk stratify people in order to better predict and modify risks,” added Dr. Albright, who was not involved in the current study.
“It is well known than adverse pregnancy outcomes such as hypertension in pregnancy, fetal growth restriction, and preterm birth, lead to increased risk of cardiovascular disease and stroke later in life, so the general findings of an association between other adverse reproductive and pregnancy outcomes leads to increased stroke risk are not surprising,” she said.
“The take-home message is that outcomes for pregnancy really do provide a window to future health,” said Dr. Albright. “For clinicians, especially non-ob.gyns., knowing a complete pregnancy history for any new patient is important and can help risk-stratify patients, especially as we continue to gain knowledge like what is shown in this study.”
However, “this study did not evaluate why individual patients may have had infertility, recurrent pregnancy loss, or stillbirth, so research to look further into this association to determine if there is an underlying medical condition that could be treated and therefore possibly reduce both pregnancy complications and future stroke risks would be important,” Dr. Albright noted.
The study was supported by the Australian National Health and Medical Research Council Centres of Research Excellence; one corresponding author was supported by an Australian National Health and Medical Research Council Investigator grant. The researchers had no financial conflicts to disclose. Dr. Albright had no financial conflicts to disclose.
FROM THE BMJ
Add AFib to noncardiac surgery risk evaluation: New support
Practice has gone back and forth on whether atrial fibrillation (AFib) should be considered in the preoperative cardiovascular risk (CV) evaluation of patients slated for noncardiac surgery, and the Revised Cardiac Risk Index (RCRI), currently widely used as an assessment tool, doesn’t include the arrhythmia.
But consideration of preexisting AFib along with the RCRI predicted 30-day mortality more sharply than the RCRI alone in an analysis of data covering several million patients slated for such procedures.
Indeed, AFib emerged as a significant, independent risk factor for a number of bad postoperative outcomes. Mortality within a month of the procedure climbed about 30% for patients with AFib before the noncardiac surgery. Their 30-day risks for stroke and for heart failure hospitalization went up similarly.
The addition of AFib to the RCRI significantly improved its ability to discriminate 30-day postoperative risk levels regardless of age, sex, and type of noncardiac surgery, Amgad Mentias, MD, Cleveland Clinic, told this news organization. And “it was able to correctly up-classify patients to high risk, if AFib was there, and it was able to down-classify some patients to lower risk if it wasn’t there.”
“I think [the findings] are convincing evidence that atrial fib should at least be part of the thought process for the surgical team and the medical team taking care of the patient,” said Dr. Mentias, who is senior author on the study published in the Journal of the American College of Cardiology, with lead author Sameer Prasada, MD, also of the Cleveland Clinic.
The results “call for incorporating AFib as a risk factor in perioperative risk scores for cardiovascular morbidity and mortality,” the published report states.
Supraventricular arrhythmias had been part of the Goldman Risk Index once widely used preoperatively to assess cardiac risk before practice adopted the RCRI in the past decade, observe Anne B. Curtis, MD, and Sai Krishna C. Korada, MD, University at Buffalo, New York, in an accompanying editorial.
The current findings “demonstrate improved prediction of adverse postsurgical outcomes” from supplementing the RCRI with AFib, they write. Given associations between preexisting AFib and serious cardiac events, “it is time to ‘re-revise’ the RCRI and acknowledge the importance of AFib in predicting adverse outcomes” after noncardiac surgery.
The new findings, however, aren’t all straightforward. In one result that remains a bit of a head-scratcher, postoperative risk of myocardial infarction (MI) in patients with preexisting AFib went in the opposite direction of risk for death and other CV outcomes, falling by almost 20%.
That is “hard to explain with the available data,” the report states, but “the use of anticoagulation, whether oral or parenteral (as a bridge therapy in the perioperative period), is a plausible explanation” given the frequent role of thrombosis in triggering MIs.
Consistent with such a mechanism, the group argues, the MI risk reduction was seen primarily among patients with AFib and a CHA2DS2-VASc score of 2 or higher – that is, those at highest risk for stroke and therefore most likely to be on oral anticoagulation. The MI risk reduction wasn’t seen in such patients with a CHA2DS2-VASc score of 0 or 1.
“I think that’s part of the explanation, that anticoagulation can reduce risk of MI. But it’s not the whole explanation,” Dr. Mentias said in an interview. If it were the sole mechanism, he said, then the same oral anticoagulation that protected against MI should have also cut the postoperative stroke risk. Yet that risk climbed 40% among patients with preexisting AFib.
The analysis started with 8.6 million Medicare patients with planned noncardiac surgery, seen from 2015 to 2019, of whom 16.4% had preexisting AFib. Propensity matching for demographics, urgency and type of surgery, CHA2DS2-VASc score, and RCRI index created two cohorts for comparison: 1.13 million patients with and 1.92 million without preexisting AFib.
Preexisting AFib was associated with a higher 30-day risk for death from any cause, the primary endpoint being 8.3% versus 5.8% for those without such AFib (P < .001), for an odds ratio of 1.31 (95% confidence interval, 1.30-1.32).
Corresponding 30-day ORs for other events, all significant at P < .001, were:
- 1.31 (95% CI, 1.30-1.33) for heart failure
- 1.40 (95% CI, 1.37-1.43) for stroke
- 1.59 (95% CI, 1.43-1.75) for systemic embolism
- 1.14 (95% CI, 1.13-1.16) for major bleeding
- 0.81 (95% CI, 0.79-0.82) for MI
Those with preexisting AFib also had longer hospitalizations at a median 5 days, compared with 4 days for those without such AFib (P < .001).
The study has the limitations of most any retrospective cohort analysis. Other limitations, the report notes, include lack of information on any antiarrhythmic meds given during hospitalization or type of AFib.
For example, AFib that is permanent – compared with paroxysmal or persistent – may be associated with more atrial fibrosis, greater atrial dilatation, “and probably higher pressures inside the heart,” Dr. Mentias observed.
“That’s not always the case, but that’s the notion. So presumably people with persistent or permanent atrial fib would have more advanced heart disease, and that could imply more risk. But we did not have that kind of data.”
Dr. Mentias and Dr. Prasada report no relevant financial relationships; disclosures for the other authors are in the report. Dr. Curtis discloses serving on advisory boards for Abbott, Janssen Pharmaceuticals, Sanofi, and Milestone Pharmaceuticals; receiving honoraria for speaking from Medtronic and Zoll; and serving on a data-monitoring board for Medtronic. Dr. Korada reports he has no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Practice has gone back and forth on whether atrial fibrillation (AFib) should be considered in the preoperative cardiovascular risk (CV) evaluation of patients slated for noncardiac surgery, and the Revised Cardiac Risk Index (RCRI), currently widely used as an assessment tool, doesn’t include the arrhythmia.
But consideration of preexisting AFib along with the RCRI predicted 30-day mortality more sharply than the RCRI alone in an analysis of data covering several million patients slated for such procedures.
Indeed, AFib emerged as a significant, independent risk factor for a number of bad postoperative outcomes. Mortality within a month of the procedure climbed about 30% for patients with AFib before the noncardiac surgery. Their 30-day risks for stroke and for heart failure hospitalization went up similarly.
The addition of AFib to the RCRI significantly improved its ability to discriminate 30-day postoperative risk levels regardless of age, sex, and type of noncardiac surgery, Amgad Mentias, MD, Cleveland Clinic, told this news organization. And “it was able to correctly up-classify patients to high risk, if AFib was there, and it was able to down-classify some patients to lower risk if it wasn’t there.”
“I think [the findings] are convincing evidence that atrial fib should at least be part of the thought process for the surgical team and the medical team taking care of the patient,” said Dr. Mentias, who is senior author on the study published in the Journal of the American College of Cardiology, with lead author Sameer Prasada, MD, also of the Cleveland Clinic.
The results “call for incorporating AFib as a risk factor in perioperative risk scores for cardiovascular morbidity and mortality,” the published report states.
Supraventricular arrhythmias had been part of the Goldman Risk Index once widely used preoperatively to assess cardiac risk before practice adopted the RCRI in the past decade, observe Anne B. Curtis, MD, and Sai Krishna C. Korada, MD, University at Buffalo, New York, in an accompanying editorial.
The current findings “demonstrate improved prediction of adverse postsurgical outcomes” from supplementing the RCRI with AFib, they write. Given associations between preexisting AFib and serious cardiac events, “it is time to ‘re-revise’ the RCRI and acknowledge the importance of AFib in predicting adverse outcomes” after noncardiac surgery.
The new findings, however, aren’t all straightforward. In one result that remains a bit of a head-scratcher, postoperative risk of myocardial infarction (MI) in patients with preexisting AFib went in the opposite direction of risk for death and other CV outcomes, falling by almost 20%.
That is “hard to explain with the available data,” the report states, but “the use of anticoagulation, whether oral or parenteral (as a bridge therapy in the perioperative period), is a plausible explanation” given the frequent role of thrombosis in triggering MIs.
Consistent with such a mechanism, the group argues, the MI risk reduction was seen primarily among patients with AFib and a CHA2DS2-VASc score of 2 or higher – that is, those at highest risk for stroke and therefore most likely to be on oral anticoagulation. The MI risk reduction wasn’t seen in such patients with a CHA2DS2-VASc score of 0 or 1.
“I think that’s part of the explanation, that anticoagulation can reduce risk of MI. But it’s not the whole explanation,” Dr. Mentias said in an interview. If it were the sole mechanism, he said, then the same oral anticoagulation that protected against MI should have also cut the postoperative stroke risk. Yet that risk climbed 40% among patients with preexisting AFib.
The analysis started with 8.6 million Medicare patients with planned noncardiac surgery, seen from 2015 to 2019, of whom 16.4% had preexisting AFib. Propensity matching for demographics, urgency and type of surgery, CHA2DS2-VASc score, and RCRI index created two cohorts for comparison: 1.13 million patients with and 1.92 million without preexisting AFib.
Preexisting AFib was associated with a higher 30-day risk for death from any cause, the primary endpoint being 8.3% versus 5.8% for those without such AFib (P < .001), for an odds ratio of 1.31 (95% confidence interval, 1.30-1.32).
Corresponding 30-day ORs for other events, all significant at P < .001, were:
- 1.31 (95% CI, 1.30-1.33) for heart failure
- 1.40 (95% CI, 1.37-1.43) for stroke
- 1.59 (95% CI, 1.43-1.75) for systemic embolism
- 1.14 (95% CI, 1.13-1.16) for major bleeding
- 0.81 (95% CI, 0.79-0.82) for MI
Those with preexisting AFib also had longer hospitalizations at a median 5 days, compared with 4 days for those without such AFib (P < .001).
The study has the limitations of most any retrospective cohort analysis. Other limitations, the report notes, include lack of information on any antiarrhythmic meds given during hospitalization or type of AFib.
For example, AFib that is permanent – compared with paroxysmal or persistent – may be associated with more atrial fibrosis, greater atrial dilatation, “and probably higher pressures inside the heart,” Dr. Mentias observed.
“That’s not always the case, but that’s the notion. So presumably people with persistent or permanent atrial fib would have more advanced heart disease, and that could imply more risk. But we did not have that kind of data.”
Dr. Mentias and Dr. Prasada report no relevant financial relationships; disclosures for the other authors are in the report. Dr. Curtis discloses serving on advisory boards for Abbott, Janssen Pharmaceuticals, Sanofi, and Milestone Pharmaceuticals; receiving honoraria for speaking from Medtronic and Zoll; and serving on a data-monitoring board for Medtronic. Dr. Korada reports he has no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Practice has gone back and forth on whether atrial fibrillation (AFib) should be considered in the preoperative cardiovascular risk (CV) evaluation of patients slated for noncardiac surgery, and the Revised Cardiac Risk Index (RCRI), currently widely used as an assessment tool, doesn’t include the arrhythmia.
But consideration of preexisting AFib along with the RCRI predicted 30-day mortality more sharply than the RCRI alone in an analysis of data covering several million patients slated for such procedures.
Indeed, AFib emerged as a significant, independent risk factor for a number of bad postoperative outcomes. Mortality within a month of the procedure climbed about 30% for patients with AFib before the noncardiac surgery. Their 30-day risks for stroke and for heart failure hospitalization went up similarly.
The addition of AFib to the RCRI significantly improved its ability to discriminate 30-day postoperative risk levels regardless of age, sex, and type of noncardiac surgery, Amgad Mentias, MD, Cleveland Clinic, told this news organization. And “it was able to correctly up-classify patients to high risk, if AFib was there, and it was able to down-classify some patients to lower risk if it wasn’t there.”
“I think [the findings] are convincing evidence that atrial fib should at least be part of the thought process for the surgical team and the medical team taking care of the patient,” said Dr. Mentias, who is senior author on the study published in the Journal of the American College of Cardiology, with lead author Sameer Prasada, MD, also of the Cleveland Clinic.
The results “call for incorporating AFib as a risk factor in perioperative risk scores for cardiovascular morbidity and mortality,” the published report states.
Supraventricular arrhythmias had been part of the Goldman Risk Index once widely used preoperatively to assess cardiac risk before practice adopted the RCRI in the past decade, observe Anne B. Curtis, MD, and Sai Krishna C. Korada, MD, University at Buffalo, New York, in an accompanying editorial.
The current findings “demonstrate improved prediction of adverse postsurgical outcomes” from supplementing the RCRI with AFib, they write. Given associations between preexisting AFib and serious cardiac events, “it is time to ‘re-revise’ the RCRI and acknowledge the importance of AFib in predicting adverse outcomes” after noncardiac surgery.
The new findings, however, aren’t all straightforward. In one result that remains a bit of a head-scratcher, postoperative risk of myocardial infarction (MI) in patients with preexisting AFib went in the opposite direction of risk for death and other CV outcomes, falling by almost 20%.
That is “hard to explain with the available data,” the report states, but “the use of anticoagulation, whether oral or parenteral (as a bridge therapy in the perioperative period), is a plausible explanation” given the frequent role of thrombosis in triggering MIs.
Consistent with such a mechanism, the group argues, the MI risk reduction was seen primarily among patients with AFib and a CHA2DS2-VASc score of 2 or higher – that is, those at highest risk for stroke and therefore most likely to be on oral anticoagulation. The MI risk reduction wasn’t seen in such patients with a CHA2DS2-VASc score of 0 or 1.
“I think that’s part of the explanation, that anticoagulation can reduce risk of MI. But it’s not the whole explanation,” Dr. Mentias said in an interview. If it were the sole mechanism, he said, then the same oral anticoagulation that protected against MI should have also cut the postoperative stroke risk. Yet that risk climbed 40% among patients with preexisting AFib.
The analysis started with 8.6 million Medicare patients with planned noncardiac surgery, seen from 2015 to 2019, of whom 16.4% had preexisting AFib. Propensity matching for demographics, urgency and type of surgery, CHA2DS2-VASc score, and RCRI index created two cohorts for comparison: 1.13 million patients with and 1.92 million without preexisting AFib.
Preexisting AFib was associated with a higher 30-day risk for death from any cause, the primary endpoint being 8.3% versus 5.8% for those without such AFib (P < .001), for an odds ratio of 1.31 (95% confidence interval, 1.30-1.32).
Corresponding 30-day ORs for other events, all significant at P < .001, were:
- 1.31 (95% CI, 1.30-1.33) for heart failure
- 1.40 (95% CI, 1.37-1.43) for stroke
- 1.59 (95% CI, 1.43-1.75) for systemic embolism
- 1.14 (95% CI, 1.13-1.16) for major bleeding
- 0.81 (95% CI, 0.79-0.82) for MI
Those with preexisting AFib also had longer hospitalizations at a median 5 days, compared with 4 days for those without such AFib (P < .001).
The study has the limitations of most any retrospective cohort analysis. Other limitations, the report notes, include lack of information on any antiarrhythmic meds given during hospitalization or type of AFib.
For example, AFib that is permanent – compared with paroxysmal or persistent – may be associated with more atrial fibrosis, greater atrial dilatation, “and probably higher pressures inside the heart,” Dr. Mentias observed.
“That’s not always the case, but that’s the notion. So presumably people with persistent or permanent atrial fib would have more advanced heart disease, and that could imply more risk. But we did not have that kind of data.”
Dr. Mentias and Dr. Prasada report no relevant financial relationships; disclosures for the other authors are in the report. Dr. Curtis discloses serving on advisory boards for Abbott, Janssen Pharmaceuticals, Sanofi, and Milestone Pharmaceuticals; receiving honoraria for speaking from Medtronic and Zoll; and serving on a data-monitoring board for Medtronic. Dr. Korada reports he has no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Jury still out on cardiovascular safety of testosterone
Despite a new meta-analysis claiming to show that testosterone replacement therapy for men with hypogonadism does not increase the risk of cardiovascular outcomes such as myocardial infarction or stroke, experts say the jury is still out.
A more definitive answer for cardiovascular safety of testosterone therapy will come from the TRAVERSE dedicated cardiovascular outcome trial, sponsored by AbbVie, which will have up to 5 years of follow-up, with results expected later this year.
The current meta-analysis by Jemma Hudson of Aberdeen (Scotland) University and colleagues was published online in The Lancet Healthy Longevity. The work will also be presented June 13 at ENDO 2022, the Endocrine Society’s annual meeting in Atlanta, Georgia, by senior author Channa Y. Jayasena, MD, PhD.
In 2014, the U.S. Food and Drug Administration mandated a label on testosterone products warning of possible increased cardiovascular risks and to reserve the therapy for symptomatic hypogonadism only. In contrast, the European Medicines Agency concluded that when hypogonadism is properly diagnosed and managed, there is currently no clear, consistent evidence that testosterone therapy causes increased cardiovascular risk.
To address this uncertainty, Dr. Hudson and colleagues formed a global collaborative to obtain individual patient data on cardiovascular outcomes from randomized controlled trials of testosterone therapy for men with hypogonadism.
They pooled data from 35 trials published from 1992 to Aug. 27, 2018, including 17 trials (3,431 patients) for which the researchers obtained patient-level data. The individual trials were 3-12 months long, except for one 3-year trial.
During a mean follow-up of 9.5 months, there was no significant increase in cardiovascular outcomes in men randomized to testosterone therapy versus placebo (odds ratio, 1.07; P = .62), nor were there any significantly increased risks of death, stroke, or different types of cardiovascular outcome, although those numbers were small.
This is “the most comprehensive study to date investigating the safety of testosterone treatment of hypogonadism,” according to the researchers. “The current results provide some reassurance about the short-term to medium-term safety of testosterone to treat male hypogonadism,” they conclude.
However, they also acknowledge that “long-term data are needed to fully evaluate the safety of testosterone.”
Erin D. Michos, MD, coauthor of an accompanying editorial, told this news organization, “This study doesn’t say to me that low testosterone necessarily needs to be treated. It’s still not indicated in people just for a low number [for blood testosterone] with less-severe symptoms. It really comes down to each individual person, how symptomatic they are, and their cardiovascular risk.”
‘Trial is not definitive’
Dr. Michos is not the only person to be skeptical. Together with Steven Nissen, MD, an investigator for the TRAVERSE trial, she agrees that this new evidence is not yet decisive, largely because the individual trials in the meta-analysis were short and not designed as cardiovascular outcome trials.
Dr. Nissen, a cardiologist at Cleveland Clinic, added that the individual trials were heterogeneous, with “very few real cardiovascular events,” so the meta-analysis “is not definitive,” he said in an interview.
While this meta-analysis “that pooled together a lot of smaller studies is reassuring that there’s no signal of harm, it’s really inconclusive because the follow-up was really short – a mean of only 9.5 months – and you really need a larger study with longer follow up to be more conclusive,” Dr. Michos noted.
“We should have more data soon” from TRAVERSE, said Dr. Michos, from the division of cardiology, Johns Hopkins University, Baltimore, who is not involved with that study.
Meanwhile, “I don’t think [this analysis] changes the current recommendations,” she said.
“We should continue to use caution as indicated by the FDA label and only use testosterone therapy selectively in people who have true symptoms of hypogonadism,” and be cautious about using it particularly in men at higher cardiovascular risk because of family history or known personal heart disease.
On the other hand, the meta-analysis did not show harm, she noted, “so we don’t necessarily need to pull patients off therapy if they are already taking it. But I wouldn’t right now just start new patients on it unless they had a strong indication.”
“Certainly, great caution is advised regarding the use of testosterone replacement therapy in people with established atherosclerosis due to the findings of plaque progression in the testosterone trials and the excess cardiovascular events observed in the TOM trial, write Dr. Michos and fellow editorialist Matthew J. Budoff, MD, of University of California, Los Angeles, in their editorial.
Earlier data inconclusive
Testosterone concentrations progressively decline in men with advancing age, at about 2% per year, Dr. Michos and Dr. Budoff write. In addition, men with obesity or with diabetes have low levels of testosterone, Dr. Michos noted.
Low testosterone blood levels have been associated with insulin resistance, inflammation, dyslipidemia, and atherosclerosis. Testosterone replacement therapy has been used to increase libido, improve erectile dysfunction, and boost energy levels, mood, and muscle strength.
But it is well known that testosterone increases hematocrit, which has the potential to increase the risk of venous thromboembolism.
Two large observational studies have reported increased risks of myocardial infarction, stroke, and death in men taking testosterone, compared with nonusers, but the study designs have been widely criticized, Dr. Hudson and coauthors say in their article.
A placebo-controlled trial was stopped early by its data- and safety-monitoring board following increased cardiovascular events in men aged 65 and older who received 6 months of testosterone. Other controlled trials have not observed these effects, but none was sufficiently powered.
Meta-analysis results
Dr. Hudson and colleagues performed a meta-analysis of 35 trials in 5,601 men aged 18 years and older with low baseline testosterone (≤ 350 nmol/dL) who had been randomized to testosterone replacement therapy or placebo for at least 3 months, for which there were data on mortality, stroke, and cardiovascular outcomes.
The men were a mean age of 65, had a mean body mass index of 30 kg/m2, and most (88%) were White. A quarter had angina, 8% had a previous myocardial infarction, and 27% had diabetes.
Cardiovascular and cerebrovascular outcomes were not primary outcomes.
During a mean follow-up of 9.5 months, in the 13 trials that provided this information, the rate of cardiovascular events was similar in the men who received testosterone (120/1,601, 7.5%) compared with those who received placebo (110/1,519, 7.2%).
In the 14 trials that provided this information, fewer deaths were reported during testosterone treatment (6/1,621, 0.4%) than during placebo treatment (12/1,537, 0.8%), but these numbers were too small to establish whether testosterone reduced mortality risk.
The most common cardiovascular events were arrhythmia, followed by coronary heart disease, heart failure, and myocardial infarction.
Patient age, baseline testosterone, smoking status, or diabetes status were not associated with cardiovascular risk.
The only detected adverse effects were edema and a modest lowering of HDL cholesterol.
“Men who develop sexual dysfunction, unexplained anemia, or osteoporosis should be tested for low testosterone,” senior author of the meta-analysis Dr. Jayasena said in an email to this news organization.
However, Dr. Jayasena added, “Mass screening for testosterone has no benefit in asymptomatic men.”
“Older men may still benefit from testosterone, but only if they have the clinical features [of hypogonadism] and low testosterone levels,” he concluded.
The current study is supported by the Health Technology Assessment program of the National Institute for Health Research. The TRAVERSE trial is sponsored by AbbVie. Dr. Jayasena has reported receiving research grants from LogixX Pharma. Dr. Hudson has reported no relevant financial relationships. Disclosures for the other authors are listed in the article. Dr. Michos has reported receiving support from the Amato Fund in Women’s Cardiovascular Health at Johns Hopkins School of Medicine and serving on medical advisory boards for Novartis, Esperion, Amarin, and AstraZeneca outside the submitted work. Dr. Budoff has reported receiving grant support from General Electric.
A version of this article first appeared on Medscape.com.
Despite a new meta-analysis claiming to show that testosterone replacement therapy for men with hypogonadism does not increase the risk of cardiovascular outcomes such as myocardial infarction or stroke, experts say the jury is still out.
A more definitive answer for cardiovascular safety of testosterone therapy will come from the TRAVERSE dedicated cardiovascular outcome trial, sponsored by AbbVie, which will have up to 5 years of follow-up, with results expected later this year.
The current meta-analysis by Jemma Hudson of Aberdeen (Scotland) University and colleagues was published online in The Lancet Healthy Longevity. The work will also be presented June 13 at ENDO 2022, the Endocrine Society’s annual meeting in Atlanta, Georgia, by senior author Channa Y. Jayasena, MD, PhD.
In 2014, the U.S. Food and Drug Administration mandated a label on testosterone products warning of possible increased cardiovascular risks and to reserve the therapy for symptomatic hypogonadism only. In contrast, the European Medicines Agency concluded that when hypogonadism is properly diagnosed and managed, there is currently no clear, consistent evidence that testosterone therapy causes increased cardiovascular risk.
To address this uncertainty, Dr. Hudson and colleagues formed a global collaborative to obtain individual patient data on cardiovascular outcomes from randomized controlled trials of testosterone therapy for men with hypogonadism.
They pooled data from 35 trials published from 1992 to Aug. 27, 2018, including 17 trials (3,431 patients) for which the researchers obtained patient-level data. The individual trials were 3-12 months long, except for one 3-year trial.
During a mean follow-up of 9.5 months, there was no significant increase in cardiovascular outcomes in men randomized to testosterone therapy versus placebo (odds ratio, 1.07; P = .62), nor were there any significantly increased risks of death, stroke, or different types of cardiovascular outcome, although those numbers were small.
This is “the most comprehensive study to date investigating the safety of testosterone treatment of hypogonadism,” according to the researchers. “The current results provide some reassurance about the short-term to medium-term safety of testosterone to treat male hypogonadism,” they conclude.
However, they also acknowledge that “long-term data are needed to fully evaluate the safety of testosterone.”
Erin D. Michos, MD, coauthor of an accompanying editorial, told this news organization, “This study doesn’t say to me that low testosterone necessarily needs to be treated. It’s still not indicated in people just for a low number [for blood testosterone] with less-severe symptoms. It really comes down to each individual person, how symptomatic they are, and their cardiovascular risk.”
‘Trial is not definitive’
Dr. Michos is not the only person to be skeptical. Together with Steven Nissen, MD, an investigator for the TRAVERSE trial, she agrees that this new evidence is not yet decisive, largely because the individual trials in the meta-analysis were short and not designed as cardiovascular outcome trials.
Dr. Nissen, a cardiologist at Cleveland Clinic, added that the individual trials were heterogeneous, with “very few real cardiovascular events,” so the meta-analysis “is not definitive,” he said in an interview.
While this meta-analysis “that pooled together a lot of smaller studies is reassuring that there’s no signal of harm, it’s really inconclusive because the follow-up was really short – a mean of only 9.5 months – and you really need a larger study with longer follow up to be more conclusive,” Dr. Michos noted.
“We should have more data soon” from TRAVERSE, said Dr. Michos, from the division of cardiology, Johns Hopkins University, Baltimore, who is not involved with that study.
Meanwhile, “I don’t think [this analysis] changes the current recommendations,” she said.
“We should continue to use caution as indicated by the FDA label and only use testosterone therapy selectively in people who have true symptoms of hypogonadism,” and be cautious about using it particularly in men at higher cardiovascular risk because of family history or known personal heart disease.
On the other hand, the meta-analysis did not show harm, she noted, “so we don’t necessarily need to pull patients off therapy if they are already taking it. But I wouldn’t right now just start new patients on it unless they had a strong indication.”
“Certainly, great caution is advised regarding the use of testosterone replacement therapy in people with established atherosclerosis due to the findings of plaque progression in the testosterone trials and the excess cardiovascular events observed in the TOM trial, write Dr. Michos and fellow editorialist Matthew J. Budoff, MD, of University of California, Los Angeles, in their editorial.
Earlier data inconclusive
Testosterone concentrations progressively decline in men with advancing age, at about 2% per year, Dr. Michos and Dr. Budoff write. In addition, men with obesity or with diabetes have low levels of testosterone, Dr. Michos noted.
Low testosterone blood levels have been associated with insulin resistance, inflammation, dyslipidemia, and atherosclerosis. Testosterone replacement therapy has been used to increase libido, improve erectile dysfunction, and boost energy levels, mood, and muscle strength.
But it is well known that testosterone increases hematocrit, which has the potential to increase the risk of venous thromboembolism.
Two large observational studies have reported increased risks of myocardial infarction, stroke, and death in men taking testosterone, compared with nonusers, but the study designs have been widely criticized, Dr. Hudson and coauthors say in their article.
A placebo-controlled trial was stopped early by its data- and safety-monitoring board following increased cardiovascular events in men aged 65 and older who received 6 months of testosterone. Other controlled trials have not observed these effects, but none was sufficiently powered.
Meta-analysis results
Dr. Hudson and colleagues performed a meta-analysis of 35 trials in 5,601 men aged 18 years and older with low baseline testosterone (≤ 350 nmol/dL) who had been randomized to testosterone replacement therapy or placebo for at least 3 months, for which there were data on mortality, stroke, and cardiovascular outcomes.
The men were a mean age of 65, had a mean body mass index of 30 kg/m2, and most (88%) were White. A quarter had angina, 8% had a previous myocardial infarction, and 27% had diabetes.
Cardiovascular and cerebrovascular outcomes were not primary outcomes.
During a mean follow-up of 9.5 months, in the 13 trials that provided this information, the rate of cardiovascular events was similar in the men who received testosterone (120/1,601, 7.5%) compared with those who received placebo (110/1,519, 7.2%).
In the 14 trials that provided this information, fewer deaths were reported during testosterone treatment (6/1,621, 0.4%) than during placebo treatment (12/1,537, 0.8%), but these numbers were too small to establish whether testosterone reduced mortality risk.
The most common cardiovascular events were arrhythmia, followed by coronary heart disease, heart failure, and myocardial infarction.
Patient age, baseline testosterone, smoking status, or diabetes status were not associated with cardiovascular risk.
The only detected adverse effects were edema and a modest lowering of HDL cholesterol.
“Men who develop sexual dysfunction, unexplained anemia, or osteoporosis should be tested for low testosterone,” senior author of the meta-analysis Dr. Jayasena said in an email to this news organization.
However, Dr. Jayasena added, “Mass screening for testosterone has no benefit in asymptomatic men.”
“Older men may still benefit from testosterone, but only if they have the clinical features [of hypogonadism] and low testosterone levels,” he concluded.
The current study is supported by the Health Technology Assessment program of the National Institute for Health Research. The TRAVERSE trial is sponsored by AbbVie. Dr. Jayasena has reported receiving research grants from LogixX Pharma. Dr. Hudson has reported no relevant financial relationships. Disclosures for the other authors are listed in the article. Dr. Michos has reported receiving support from the Amato Fund in Women’s Cardiovascular Health at Johns Hopkins School of Medicine and serving on medical advisory boards for Novartis, Esperion, Amarin, and AstraZeneca outside the submitted work. Dr. Budoff has reported receiving grant support from General Electric.
A version of this article first appeared on Medscape.com.
Despite a new meta-analysis claiming to show that testosterone replacement therapy for men with hypogonadism does not increase the risk of cardiovascular outcomes such as myocardial infarction or stroke, experts say the jury is still out.
A more definitive answer for cardiovascular safety of testosterone therapy will come from the TRAVERSE dedicated cardiovascular outcome trial, sponsored by AbbVie, which will have up to 5 years of follow-up, with results expected later this year.
The current meta-analysis by Jemma Hudson of Aberdeen (Scotland) University and colleagues was published online in The Lancet Healthy Longevity. The work will also be presented June 13 at ENDO 2022, the Endocrine Society’s annual meeting in Atlanta, Georgia, by senior author Channa Y. Jayasena, MD, PhD.
In 2014, the U.S. Food and Drug Administration mandated a label on testosterone products warning of possible increased cardiovascular risks and to reserve the therapy for symptomatic hypogonadism only. In contrast, the European Medicines Agency concluded that when hypogonadism is properly diagnosed and managed, there is currently no clear, consistent evidence that testosterone therapy causes increased cardiovascular risk.
To address this uncertainty, Dr. Hudson and colleagues formed a global collaborative to obtain individual patient data on cardiovascular outcomes from randomized controlled trials of testosterone therapy for men with hypogonadism.
They pooled data from 35 trials published from 1992 to Aug. 27, 2018, including 17 trials (3,431 patients) for which the researchers obtained patient-level data. The individual trials were 3-12 months long, except for one 3-year trial.
During a mean follow-up of 9.5 months, there was no significant increase in cardiovascular outcomes in men randomized to testosterone therapy versus placebo (odds ratio, 1.07; P = .62), nor were there any significantly increased risks of death, stroke, or different types of cardiovascular outcome, although those numbers were small.
This is “the most comprehensive study to date investigating the safety of testosterone treatment of hypogonadism,” according to the researchers. “The current results provide some reassurance about the short-term to medium-term safety of testosterone to treat male hypogonadism,” they conclude.
However, they also acknowledge that “long-term data are needed to fully evaluate the safety of testosterone.”
Erin D. Michos, MD, coauthor of an accompanying editorial, told this news organization, “This study doesn’t say to me that low testosterone necessarily needs to be treated. It’s still not indicated in people just for a low number [for blood testosterone] with less-severe symptoms. It really comes down to each individual person, how symptomatic they are, and their cardiovascular risk.”
‘Trial is not definitive’
Dr. Michos is not the only person to be skeptical. Together with Steven Nissen, MD, an investigator for the TRAVERSE trial, she agrees that this new evidence is not yet decisive, largely because the individual trials in the meta-analysis were short and not designed as cardiovascular outcome trials.
Dr. Nissen, a cardiologist at Cleveland Clinic, added that the individual trials were heterogeneous, with “very few real cardiovascular events,” so the meta-analysis “is not definitive,” he said in an interview.
While this meta-analysis “that pooled together a lot of smaller studies is reassuring that there’s no signal of harm, it’s really inconclusive because the follow-up was really short – a mean of only 9.5 months – and you really need a larger study with longer follow up to be more conclusive,” Dr. Michos noted.
“We should have more data soon” from TRAVERSE, said Dr. Michos, from the division of cardiology, Johns Hopkins University, Baltimore, who is not involved with that study.
Meanwhile, “I don’t think [this analysis] changes the current recommendations,” she said.
“We should continue to use caution as indicated by the FDA label and only use testosterone therapy selectively in people who have true symptoms of hypogonadism,” and be cautious about using it particularly in men at higher cardiovascular risk because of family history or known personal heart disease.
On the other hand, the meta-analysis did not show harm, she noted, “so we don’t necessarily need to pull patients off therapy if they are already taking it. But I wouldn’t right now just start new patients on it unless they had a strong indication.”
“Certainly, great caution is advised regarding the use of testosterone replacement therapy in people with established atherosclerosis due to the findings of plaque progression in the testosterone trials and the excess cardiovascular events observed in the TOM trial, write Dr. Michos and fellow editorialist Matthew J. Budoff, MD, of University of California, Los Angeles, in their editorial.
Earlier data inconclusive
Testosterone concentrations progressively decline in men with advancing age, at about 2% per year, Dr. Michos and Dr. Budoff write. In addition, men with obesity or with diabetes have low levels of testosterone, Dr. Michos noted.
Low testosterone blood levels have been associated with insulin resistance, inflammation, dyslipidemia, and atherosclerosis. Testosterone replacement therapy has been used to increase libido, improve erectile dysfunction, and boost energy levels, mood, and muscle strength.
But it is well known that testosterone increases hematocrit, which has the potential to increase the risk of venous thromboembolism.
Two large observational studies have reported increased risks of myocardial infarction, stroke, and death in men taking testosterone, compared with nonusers, but the study designs have been widely criticized, Dr. Hudson and coauthors say in their article.
A placebo-controlled trial was stopped early by its data- and safety-monitoring board following increased cardiovascular events in men aged 65 and older who received 6 months of testosterone. Other controlled trials have not observed these effects, but none was sufficiently powered.
Meta-analysis results
Dr. Hudson and colleagues performed a meta-analysis of 35 trials in 5,601 men aged 18 years and older with low baseline testosterone (≤ 350 nmol/dL) who had been randomized to testosterone replacement therapy or placebo for at least 3 months, for which there were data on mortality, stroke, and cardiovascular outcomes.
The men were a mean age of 65, had a mean body mass index of 30 kg/m2, and most (88%) were White. A quarter had angina, 8% had a previous myocardial infarction, and 27% had diabetes.
Cardiovascular and cerebrovascular outcomes were not primary outcomes.
During a mean follow-up of 9.5 months, in the 13 trials that provided this information, the rate of cardiovascular events was similar in the men who received testosterone (120/1,601, 7.5%) compared with those who received placebo (110/1,519, 7.2%).
In the 14 trials that provided this information, fewer deaths were reported during testosterone treatment (6/1,621, 0.4%) than during placebo treatment (12/1,537, 0.8%), but these numbers were too small to establish whether testosterone reduced mortality risk.
The most common cardiovascular events were arrhythmia, followed by coronary heart disease, heart failure, and myocardial infarction.
Patient age, baseline testosterone, smoking status, or diabetes status were not associated with cardiovascular risk.
The only detected adverse effects were edema and a modest lowering of HDL cholesterol.
“Men who develop sexual dysfunction, unexplained anemia, or osteoporosis should be tested for low testosterone,” senior author of the meta-analysis Dr. Jayasena said in an email to this news organization.
However, Dr. Jayasena added, “Mass screening for testosterone has no benefit in asymptomatic men.”
“Older men may still benefit from testosterone, but only if they have the clinical features [of hypogonadism] and low testosterone levels,” he concluded.
The current study is supported by the Health Technology Assessment program of the National Institute for Health Research. The TRAVERSE trial is sponsored by AbbVie. Dr. Jayasena has reported receiving research grants from LogixX Pharma. Dr. Hudson has reported no relevant financial relationships. Disclosures for the other authors are listed in the article. Dr. Michos has reported receiving support from the Amato Fund in Women’s Cardiovascular Health at Johns Hopkins School of Medicine and serving on medical advisory boards for Novartis, Esperion, Amarin, and AstraZeneca outside the submitted work. Dr. Budoff has reported receiving grant support from General Electric.
A version of this article first appeared on Medscape.com.
FROM THE LANCET HEALTHY LONGEVITY
‘Sit less, move more’ to reduce stroke risk
in a population-based study of middle aged and older adults.
The study also found relatively short periods of moderate to vigorous exercise were associated with reduced stroke risk.
“Our results suggest there are a number of ways to reduce stroke risk simply by moving about,” said lead author Steven P. Hooker, PhD, San Diego State University. “This could be with short periods of moderate to vigorous activity each day, longer periods of light activity, or just sedentary for shorter periods of time. All these things can make a difference.”
Dr. Hooker explained that, while it has been found previously that moderate to vigorous exercise reduces stroke risk, this study gives more information on light-intensity activities and sedentary behavior and the risk of stroke.
“Our results suggest that you don’t have to be a chronic exerciser to reduce stroke risk. Replacing sedentary time with light-intensity activity will be beneficial. Just go for a short walk, get up from your desk and move around the house at regular intervals. That can help to reduce stroke risk,” Dr. Hooker said.
“Our message is basically to sit less and move more,” he added.
The study was published online in JAMA Network Open.
The study involved 7,607 U.S. individuals without a history of stroke, with oversampling from the southeastern “Stroke Belt,” who were participating in the REGARDS cohort study.
The participants wore an accelerometer to measure physical activity and sedentary behavior for 7 consecutive days. The mean age of the individuals was 63 years; 54% were female, 32% were Black.
Over a mean follow-up of 7.4 years, 286 incident stroke cases occurred.
Results showed that increased levels of physical activity were associated with reduced risk of stroke.
For moderate to vigorous activity, compared with participants in the lowest tertile, those in the highest tertile of total daily time in moderate to vigorous activity had a 43% lower risk of stroke.
In the current study, the amount of moderate to vigorous activity associated with a significant reduction in stroke risk was approximately 25 minutes per day (3 hours per week).
Dr. Hooker noted that moderate to vigorous activity included things such as brisk walking, jogging, bike riding, swimming, or playing tennis or soccer. “Doing such activities for just 25 minutes per day reduced risk of stroke by 43%. This is very doable. Just commuting to work by bicycle would cover you here,” he said.
In terms of light-intensity activity, individuals who did 4-5 hours of light activities each day had a 26% reduced risk for first stroke, compared with those doing less than 3 hours of such light activities.
Dr. Hooker explained that examples of light activity included household chores, such as vacuuming, washing dishes, or going for a gentle stroll. “These activities do not require heaving breathing, increased heart rate or breaking into a sweat. They are activities of daily living and relatively easy to engage in.”
But he pointed out that the 4-5 hours of light activity every day linked to a reduction in stroke risk may be more difficult to achieve than the 25 minutes of moderate to vigorous activity, saying: “You have to have some intentionality here.”
Long bouts of sedentary time are harmful
The study also showed that sedentary time was associated with a higher risk for stroke.
The authors noted that time spent in sedentary behavior is of interest because most adults spend most of their awake time being physically inactive.
They report that participants in the highest tertile of sedentary time (more than 13 hours/day) exhibited a 44% increase in risk of stroke, compared with those in the lowest tertile (less than 11 hours/day), and the association remained significant when adjusted for several covariates, including moderate to vigorous activity.
“Even when controlling for the amount of other physical activity, sedentary behavior is still highly associated with risk of stroke. So even if you are active, long bouts of sedentary behavior are harmful,” Dr. Hooker commented.
They also found that longer bouts of sedentary time (more than 17 minutes at a time) were associated with a 54% higher risk of stroke than shorter bouts (less than 8 minutes).
“This suggests that breaking up periods of sedentary behavior into shorter bouts would be beneficial,” Dr. Hooker said.
“If you are going to spend the evening on the couch watching television, try to stand up and walk around every few minutes. Same for if you are sitting at a computer all day – try having a standing workstation, or at least take regular breaks to walk around,” he added.
This research was supported by grants from the National Institute of Neurological Disorders and Stroke and the National Institute on Aging. Additional funding was provided by an unrestricted grant from the Coca-Cola Company. The authors report no disclosures.
A version of this article first appeared on Medscape.com.
in a population-based study of middle aged and older adults.
The study also found relatively short periods of moderate to vigorous exercise were associated with reduced stroke risk.
“Our results suggest there are a number of ways to reduce stroke risk simply by moving about,” said lead author Steven P. Hooker, PhD, San Diego State University. “This could be with short periods of moderate to vigorous activity each day, longer periods of light activity, or just sedentary for shorter periods of time. All these things can make a difference.”
Dr. Hooker explained that, while it has been found previously that moderate to vigorous exercise reduces stroke risk, this study gives more information on light-intensity activities and sedentary behavior and the risk of stroke.
“Our results suggest that you don’t have to be a chronic exerciser to reduce stroke risk. Replacing sedentary time with light-intensity activity will be beneficial. Just go for a short walk, get up from your desk and move around the house at regular intervals. That can help to reduce stroke risk,” Dr. Hooker said.
“Our message is basically to sit less and move more,” he added.
The study was published online in JAMA Network Open.
The study involved 7,607 U.S. individuals without a history of stroke, with oversampling from the southeastern “Stroke Belt,” who were participating in the REGARDS cohort study.
The participants wore an accelerometer to measure physical activity and sedentary behavior for 7 consecutive days. The mean age of the individuals was 63 years; 54% were female, 32% were Black.
Over a mean follow-up of 7.4 years, 286 incident stroke cases occurred.
Results showed that increased levels of physical activity were associated with reduced risk of stroke.
For moderate to vigorous activity, compared with participants in the lowest tertile, those in the highest tertile of total daily time in moderate to vigorous activity had a 43% lower risk of stroke.
In the current study, the amount of moderate to vigorous activity associated with a significant reduction in stroke risk was approximately 25 minutes per day (3 hours per week).
Dr. Hooker noted that moderate to vigorous activity included things such as brisk walking, jogging, bike riding, swimming, or playing tennis or soccer. “Doing such activities for just 25 minutes per day reduced risk of stroke by 43%. This is very doable. Just commuting to work by bicycle would cover you here,” he said.
In terms of light-intensity activity, individuals who did 4-5 hours of light activities each day had a 26% reduced risk for first stroke, compared with those doing less than 3 hours of such light activities.
Dr. Hooker explained that examples of light activity included household chores, such as vacuuming, washing dishes, or going for a gentle stroll. “These activities do not require heaving breathing, increased heart rate or breaking into a sweat. They are activities of daily living and relatively easy to engage in.”
But he pointed out that the 4-5 hours of light activity every day linked to a reduction in stroke risk may be more difficult to achieve than the 25 minutes of moderate to vigorous activity, saying: “You have to have some intentionality here.”
Long bouts of sedentary time are harmful
The study also showed that sedentary time was associated with a higher risk for stroke.
The authors noted that time spent in sedentary behavior is of interest because most adults spend most of their awake time being physically inactive.
They report that participants in the highest tertile of sedentary time (more than 13 hours/day) exhibited a 44% increase in risk of stroke, compared with those in the lowest tertile (less than 11 hours/day), and the association remained significant when adjusted for several covariates, including moderate to vigorous activity.
“Even when controlling for the amount of other physical activity, sedentary behavior is still highly associated with risk of stroke. So even if you are active, long bouts of sedentary behavior are harmful,” Dr. Hooker commented.
They also found that longer bouts of sedentary time (more than 17 minutes at a time) were associated with a 54% higher risk of stroke than shorter bouts (less than 8 minutes).
“This suggests that breaking up periods of sedentary behavior into shorter bouts would be beneficial,” Dr. Hooker said.
“If you are going to spend the evening on the couch watching television, try to stand up and walk around every few minutes. Same for if you are sitting at a computer all day – try having a standing workstation, or at least take regular breaks to walk around,” he added.
This research was supported by grants from the National Institute of Neurological Disorders and Stroke and the National Institute on Aging. Additional funding was provided by an unrestricted grant from the Coca-Cola Company. The authors report no disclosures.
A version of this article first appeared on Medscape.com.
in a population-based study of middle aged and older adults.
The study also found relatively short periods of moderate to vigorous exercise were associated with reduced stroke risk.
“Our results suggest there are a number of ways to reduce stroke risk simply by moving about,” said lead author Steven P. Hooker, PhD, San Diego State University. “This could be with short periods of moderate to vigorous activity each day, longer periods of light activity, or just sedentary for shorter periods of time. All these things can make a difference.”
Dr. Hooker explained that, while it has been found previously that moderate to vigorous exercise reduces stroke risk, this study gives more information on light-intensity activities and sedentary behavior and the risk of stroke.
“Our results suggest that you don’t have to be a chronic exerciser to reduce stroke risk. Replacing sedentary time with light-intensity activity will be beneficial. Just go for a short walk, get up from your desk and move around the house at regular intervals. That can help to reduce stroke risk,” Dr. Hooker said.
“Our message is basically to sit less and move more,” he added.
The study was published online in JAMA Network Open.
The study involved 7,607 U.S. individuals without a history of stroke, with oversampling from the southeastern “Stroke Belt,” who were participating in the REGARDS cohort study.
The participants wore an accelerometer to measure physical activity and sedentary behavior for 7 consecutive days. The mean age of the individuals was 63 years; 54% were female, 32% were Black.
Over a mean follow-up of 7.4 years, 286 incident stroke cases occurred.
Results showed that increased levels of physical activity were associated with reduced risk of stroke.
For moderate to vigorous activity, compared with participants in the lowest tertile, those in the highest tertile of total daily time in moderate to vigorous activity had a 43% lower risk of stroke.
In the current study, the amount of moderate to vigorous activity associated with a significant reduction in stroke risk was approximately 25 minutes per day (3 hours per week).
Dr. Hooker noted that moderate to vigorous activity included things such as brisk walking, jogging, bike riding, swimming, or playing tennis or soccer. “Doing such activities for just 25 minutes per day reduced risk of stroke by 43%. This is very doable. Just commuting to work by bicycle would cover you here,” he said.
In terms of light-intensity activity, individuals who did 4-5 hours of light activities each day had a 26% reduced risk for first stroke, compared with those doing less than 3 hours of such light activities.
Dr. Hooker explained that examples of light activity included household chores, such as vacuuming, washing dishes, or going for a gentle stroll. “These activities do not require heaving breathing, increased heart rate or breaking into a sweat. They are activities of daily living and relatively easy to engage in.”
But he pointed out that the 4-5 hours of light activity every day linked to a reduction in stroke risk may be more difficult to achieve than the 25 minutes of moderate to vigorous activity, saying: “You have to have some intentionality here.”
Long bouts of sedentary time are harmful
The study also showed that sedentary time was associated with a higher risk for stroke.
The authors noted that time spent in sedentary behavior is of interest because most adults spend most of their awake time being physically inactive.
They report that participants in the highest tertile of sedentary time (more than 13 hours/day) exhibited a 44% increase in risk of stroke, compared with those in the lowest tertile (less than 11 hours/day), and the association remained significant when adjusted for several covariates, including moderate to vigorous activity.
“Even when controlling for the amount of other physical activity, sedentary behavior is still highly associated with risk of stroke. So even if you are active, long bouts of sedentary behavior are harmful,” Dr. Hooker commented.
They also found that longer bouts of sedentary time (more than 17 minutes at a time) were associated with a 54% higher risk of stroke than shorter bouts (less than 8 minutes).
“This suggests that breaking up periods of sedentary behavior into shorter bouts would be beneficial,” Dr. Hooker said.
“If you are going to spend the evening on the couch watching television, try to stand up and walk around every few minutes. Same for if you are sitting at a computer all day – try having a standing workstation, or at least take regular breaks to walk around,” he added.
This research was supported by grants from the National Institute of Neurological Disorders and Stroke and the National Institute on Aging. Additional funding was provided by an unrestricted grant from the Coca-Cola Company. The authors report no disclosures.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Thrombolysis is safe in stroke patients on oral anticoagulants
, a new observational study suggests, prompting researchers to ask whether guidelines that restrict its use should be updated.
Researchers found that DOAC users were significantly less likely to develop symptomatic intracerebral hemorrhage (sICH) after IVT, and there was no difference in functional independence at 3 months, compared with patients who received IVT but who did not receive DOAC.
“At the moment, the guidelines really pose a barrier and stop sign in front of the most important medical reperfusion therapy, which is thrombolysis,” said principal investigator Jan Purrucker, MD, professor of neurology at Heidelberg University Hospital.
“The main question we have to answer is, is IVT safe in patients with acute ischemic stroke who were pretreated with direct oral anticoagulants or not?”
The findings were presented at the European Stroke Organisation Conference (ESOC) 2022, Lyon, France.
A ‘daily clinical problem’
As many as 20% of patients with atrial fibrillation experience ischemic stroke while receiving DOAC therapy. Reperfusion therapy with intravenous alteplase is considered standard of care for acute ischemic stroke, but current guidelines recommend against the use of IVT for patients who have recently received a DOAC, owing to safety concerns that researchers say are not backed by strong clinical evidence.
A recent study found no significant difference in sICH among patients who received IV alteplase for acute ischemic stroke within 7 days of receiving therapy with non–vitamin K antagonist oral anticoagulants.
“In our daily clinical practice, we face a lot of patients who have received oral anticoagulation, many with atrial fibrillation, but a lot of other indicators as well, and they suffer from ischemic stroke,” Dr. Purrucker said. “They usually are ineligible for medical reperfusion therapy because of quite strict guideline recommendations at the moment. This is a daily clinical problem.”
Dr. Purrucker and colleagues in New Zealand and Switzerland launched an international, observational, multicenter cohort study to examine the issue.
Researchers collected data on patients with ischemic stroke who had last received DOAC therapy 48 hours or less before the event or whose last intake was unknown and who had received IVT. They included 20,448 patients, 830 of whom were receiving DOAC therapy at the time of stroke onset.
Among the DOAC users, 30% received DOAC reversal prior to IVT, 27% had their DOAC level measured, and 42% received IVT without reversal treatment or knowledge of DOAC levels.
Overall, 4.5% of patients developed sICH. Compared with the control group, DOAC users were half as likely to develop sICH (adjusted odds ratio, 0.47; P = .003).
There was no significant difference between groups in independent outcome at 3 months, defined as a Modified Rankin Scale score of 1 to 3 (aOR, 1.21; 95% confidence interval, 0.99-1.49).
This finding held across patient subgroups, including patients for whom selection methods differed and patients with very recent intake of less than 12 hours.
“The question is whether we are so confident in these data that we would change our clinical practice now,” Dr. Purrucker said.
Infrastructure needed
While the findings are promising, more data are needed to strengthen the argument for revising current IVT guidelines, said Ho-Yan Yvonne Chun, PhD, honorary senior clinical lecturer with the Centre for Clinical Brain Sciences at the University of Edinburgh and a consultant in stroke medicine for NHS Lothian and Borders General Hospital, who commented on the findings.
“The study sample are a highly selected group of patients from selected centers that have the infrastructure to offer DOAC level checking and DOAC reversal,” Dr. Chun said. “The selected centers are not representative of the majority of hospitals that offer IVT to stroke patients with acute stroke.”
Most hospitals lack the equipment necessary to test DOAC levels and don’t have immediate access to DOAC reversal agents, Dr. Chun said. In those centers, she added, the administration of IVT could be delayed, which might affect clinical outcomes.
“Infrastructure needs to be in place to ensure timely delivery of IVT to these patients,” Dr. Chun added. “This means that in real-world practice, hospitals need to have right logistical pathway in place in order to provide timely DOAC level checking and DOAC reversal agents.”
Dr. Chun added that “large pragmatic clinical trials, preferably multicentered, are needed to provide the definitive evidence on the safety and effectiveness of using these approaches to select patients with prior DOAC use for IVT.”
But such a study may not be feasible, Dr. Purrucker said. Among the hurdles he noted are the large sample size needed for such a trial, uncertainty regarding funding, and patient selection bias, resulting from the fact that such studies would likely exclude patients eligible for mechanical thrombectomy or those eligible for reversal treatment.
In light of earlier studies, including preclinical data that support the safety of DOACs in IVT, and these new data, Dr. Purrucker said he hopes a change in guidelines might be taken up in the future.
“But it should be good academic practice to first let the results be externally evaluated, for example, during the manuscript submission process,” he said. “But once published, guideline working groups will have to evaluate the recent and new evidence and might reconsider previous recommendations.”
The study received no commercial funding. Dr. Purrucker and Dr. Chun reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, a new observational study suggests, prompting researchers to ask whether guidelines that restrict its use should be updated.
Researchers found that DOAC users were significantly less likely to develop symptomatic intracerebral hemorrhage (sICH) after IVT, and there was no difference in functional independence at 3 months, compared with patients who received IVT but who did not receive DOAC.
“At the moment, the guidelines really pose a barrier and stop sign in front of the most important medical reperfusion therapy, which is thrombolysis,” said principal investigator Jan Purrucker, MD, professor of neurology at Heidelberg University Hospital.
“The main question we have to answer is, is IVT safe in patients with acute ischemic stroke who were pretreated with direct oral anticoagulants or not?”
The findings were presented at the European Stroke Organisation Conference (ESOC) 2022, Lyon, France.
A ‘daily clinical problem’
As many as 20% of patients with atrial fibrillation experience ischemic stroke while receiving DOAC therapy. Reperfusion therapy with intravenous alteplase is considered standard of care for acute ischemic stroke, but current guidelines recommend against the use of IVT for patients who have recently received a DOAC, owing to safety concerns that researchers say are not backed by strong clinical evidence.
A recent study found no significant difference in sICH among patients who received IV alteplase for acute ischemic stroke within 7 days of receiving therapy with non–vitamin K antagonist oral anticoagulants.
“In our daily clinical practice, we face a lot of patients who have received oral anticoagulation, many with atrial fibrillation, but a lot of other indicators as well, and they suffer from ischemic stroke,” Dr. Purrucker said. “They usually are ineligible for medical reperfusion therapy because of quite strict guideline recommendations at the moment. This is a daily clinical problem.”
Dr. Purrucker and colleagues in New Zealand and Switzerland launched an international, observational, multicenter cohort study to examine the issue.
Researchers collected data on patients with ischemic stroke who had last received DOAC therapy 48 hours or less before the event or whose last intake was unknown and who had received IVT. They included 20,448 patients, 830 of whom were receiving DOAC therapy at the time of stroke onset.
Among the DOAC users, 30% received DOAC reversal prior to IVT, 27% had their DOAC level measured, and 42% received IVT without reversal treatment or knowledge of DOAC levels.
Overall, 4.5% of patients developed sICH. Compared with the control group, DOAC users were half as likely to develop sICH (adjusted odds ratio, 0.47; P = .003).
There was no significant difference between groups in independent outcome at 3 months, defined as a Modified Rankin Scale score of 1 to 3 (aOR, 1.21; 95% confidence interval, 0.99-1.49).
This finding held across patient subgroups, including patients for whom selection methods differed and patients with very recent intake of less than 12 hours.
“The question is whether we are so confident in these data that we would change our clinical practice now,” Dr. Purrucker said.
Infrastructure needed
While the findings are promising, more data are needed to strengthen the argument for revising current IVT guidelines, said Ho-Yan Yvonne Chun, PhD, honorary senior clinical lecturer with the Centre for Clinical Brain Sciences at the University of Edinburgh and a consultant in stroke medicine for NHS Lothian and Borders General Hospital, who commented on the findings.
“The study sample are a highly selected group of patients from selected centers that have the infrastructure to offer DOAC level checking and DOAC reversal,” Dr. Chun said. “The selected centers are not representative of the majority of hospitals that offer IVT to stroke patients with acute stroke.”
Most hospitals lack the equipment necessary to test DOAC levels and don’t have immediate access to DOAC reversal agents, Dr. Chun said. In those centers, she added, the administration of IVT could be delayed, which might affect clinical outcomes.
“Infrastructure needs to be in place to ensure timely delivery of IVT to these patients,” Dr. Chun added. “This means that in real-world practice, hospitals need to have right logistical pathway in place in order to provide timely DOAC level checking and DOAC reversal agents.”
Dr. Chun added that “large pragmatic clinical trials, preferably multicentered, are needed to provide the definitive evidence on the safety and effectiveness of using these approaches to select patients with prior DOAC use for IVT.”
But such a study may not be feasible, Dr. Purrucker said. Among the hurdles he noted are the large sample size needed for such a trial, uncertainty regarding funding, and patient selection bias, resulting from the fact that such studies would likely exclude patients eligible for mechanical thrombectomy or those eligible for reversal treatment.
In light of earlier studies, including preclinical data that support the safety of DOACs in IVT, and these new data, Dr. Purrucker said he hopes a change in guidelines might be taken up in the future.
“But it should be good academic practice to first let the results be externally evaluated, for example, during the manuscript submission process,” he said. “But once published, guideline working groups will have to evaluate the recent and new evidence and might reconsider previous recommendations.”
The study received no commercial funding. Dr. Purrucker and Dr. Chun reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, a new observational study suggests, prompting researchers to ask whether guidelines that restrict its use should be updated.
Researchers found that DOAC users were significantly less likely to develop symptomatic intracerebral hemorrhage (sICH) after IVT, and there was no difference in functional independence at 3 months, compared with patients who received IVT but who did not receive DOAC.
“At the moment, the guidelines really pose a barrier and stop sign in front of the most important medical reperfusion therapy, which is thrombolysis,” said principal investigator Jan Purrucker, MD, professor of neurology at Heidelberg University Hospital.
“The main question we have to answer is, is IVT safe in patients with acute ischemic stroke who were pretreated with direct oral anticoagulants or not?”
The findings were presented at the European Stroke Organisation Conference (ESOC) 2022, Lyon, France.
A ‘daily clinical problem’
As many as 20% of patients with atrial fibrillation experience ischemic stroke while receiving DOAC therapy. Reperfusion therapy with intravenous alteplase is considered standard of care for acute ischemic stroke, but current guidelines recommend against the use of IVT for patients who have recently received a DOAC, owing to safety concerns that researchers say are not backed by strong clinical evidence.
A recent study found no significant difference in sICH among patients who received IV alteplase for acute ischemic stroke within 7 days of receiving therapy with non–vitamin K antagonist oral anticoagulants.
“In our daily clinical practice, we face a lot of patients who have received oral anticoagulation, many with atrial fibrillation, but a lot of other indicators as well, and they suffer from ischemic stroke,” Dr. Purrucker said. “They usually are ineligible for medical reperfusion therapy because of quite strict guideline recommendations at the moment. This is a daily clinical problem.”
Dr. Purrucker and colleagues in New Zealand and Switzerland launched an international, observational, multicenter cohort study to examine the issue.
Researchers collected data on patients with ischemic stroke who had last received DOAC therapy 48 hours or less before the event or whose last intake was unknown and who had received IVT. They included 20,448 patients, 830 of whom were receiving DOAC therapy at the time of stroke onset.
Among the DOAC users, 30% received DOAC reversal prior to IVT, 27% had their DOAC level measured, and 42% received IVT without reversal treatment or knowledge of DOAC levels.
Overall, 4.5% of patients developed sICH. Compared with the control group, DOAC users were half as likely to develop sICH (adjusted odds ratio, 0.47; P = .003).
There was no significant difference between groups in independent outcome at 3 months, defined as a Modified Rankin Scale score of 1 to 3 (aOR, 1.21; 95% confidence interval, 0.99-1.49).
This finding held across patient subgroups, including patients for whom selection methods differed and patients with very recent intake of less than 12 hours.
“The question is whether we are so confident in these data that we would change our clinical practice now,” Dr. Purrucker said.
Infrastructure needed
While the findings are promising, more data are needed to strengthen the argument for revising current IVT guidelines, said Ho-Yan Yvonne Chun, PhD, honorary senior clinical lecturer with the Centre for Clinical Brain Sciences at the University of Edinburgh and a consultant in stroke medicine for NHS Lothian and Borders General Hospital, who commented on the findings.
“The study sample are a highly selected group of patients from selected centers that have the infrastructure to offer DOAC level checking and DOAC reversal,” Dr. Chun said. “The selected centers are not representative of the majority of hospitals that offer IVT to stroke patients with acute stroke.”
Most hospitals lack the equipment necessary to test DOAC levels and don’t have immediate access to DOAC reversal agents, Dr. Chun said. In those centers, she added, the administration of IVT could be delayed, which might affect clinical outcomes.
“Infrastructure needs to be in place to ensure timely delivery of IVT to these patients,” Dr. Chun added. “This means that in real-world practice, hospitals need to have right logistical pathway in place in order to provide timely DOAC level checking and DOAC reversal agents.”
Dr. Chun added that “large pragmatic clinical trials, preferably multicentered, are needed to provide the definitive evidence on the safety and effectiveness of using these approaches to select patients with prior DOAC use for IVT.”
But such a study may not be feasible, Dr. Purrucker said. Among the hurdles he noted are the large sample size needed for such a trial, uncertainty regarding funding, and patient selection bias, resulting from the fact that such studies would likely exclude patients eligible for mechanical thrombectomy or those eligible for reversal treatment.
In light of earlier studies, including preclinical data that support the safety of DOACs in IVT, and these new data, Dr. Purrucker said he hopes a change in guidelines might be taken up in the future.
“But it should be good academic practice to first let the results be externally evaluated, for example, during the manuscript submission process,” he said. “But once published, guideline working groups will have to evaluate the recent and new evidence and might reconsider previous recommendations.”
The study received no commercial funding. Dr. Purrucker and Dr. Chun reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ESOC 2022
SCAI issues guidelines for PFO management, makes case for expansion
The first-ever guidelines for interventional cardiologists using percutaneous patent foramen ovale closure recommend expanding the use of the procedure beyond the Food and Drug Administration–approved indication following PFO-associated ischemic stroke, adding clarification about the use of PFO with anticoagulation and hedging against abuse and overuse of the procedure, said the chair of the guideline writing committee.
“The most important things surrounding these guidelines are to help clinicians and policymakers – third-party payers – to address PFO in patient subsets that were not included in the large randomized clinical trials that led to FDA approval,” said writing group chair Clifford J. Kavinsky, MD, PhD, chief of structural and interventional cardiology at Rush University Medical Center, Chicago.
The Society for Cardiovascular Angiography & Interventions issued the guidelines at its annual scientific sessions meeting in Atlanta and published them simultaneously in the society’s journal.
The guidelines issue strong and conditional recommendations. The former means clinicians should order the intervention for most patients; the latter means decisionmaking is more nuanced and should consider contributing factors.
The guidelines clarify patient selection for PFO closure outside the “pretty narrow” indication the FDA approved, Dr. Kavinsky said, which is for PFO-associated ischemic stroke in patients aged 18-60 years.
“So what about patients who are older than 60? What about patients who had their stroke 10 years ago?” Dr. Kavinsky asked. “Those are issues that were unanswered in the randomized clinical trials.”
The guidelines also refine recommendations about anticoagulation in these patients, including its use after PFO closure in selected patients, Dr. Kavinsky noted. “It’s the opinion of the panel that although anticoagulants may be effective, because of issues of noncompliance, because of issues of interruption of therapy by physicians for a variety of reasons, including surgery or noncompliance, that it is preferable to do a PFO device closure to giving anticoagulant therapy.”
Many of the recommendations cover PFO closure alongside antiplatelet or anticoagulation therapy. Key conditional recommendations for patients who haven’t had a PFO-related stroke are:
- Avoiding its routine use in patients with chronic migraines, prior decompression illness (DCI), thrombophilia, atrial septal aneurysm, transient ischemic attack (TIA), or deep vein thrombosis (DVT).
- Considering PFO closure in patients with platypnea-orthodeoxia syndrome (POS) with no other discernible cause of hypoxia or systemic embolism in whom other embolic causes have been ruled out.
In patients who’ve had a PFO-related stroke, the guidelines strongly recommend PFO closure versus antiplatelet therapy alone, but conditionally, not in patients with atrial fibrillation who’ve had an ischemic stroke. They also conditionally suggest PFO closure rather than long-term antiplatelet therapy alone in PFO stroke patients aged 60 and older, as well as those with thrombophilia already on antiplatelet therapy but not anticoagulation. However, the guidelines make no recommendation on PFO closure based on how much time has passed since the previous stroke.
“Furthermore,” Dr. Kavinsky said, “in patients who require lifelong anticoagulation because of recurrent DVT or recurrent pulmonary emboli or thrombopenia, if they’ve had a PFO-mediated stroke, then it’s our opinion that they should have their PFO closed in addition to taking lifelong anticoagulation because of the same issues of noncompliance and interruption of therapy.” Those are conditional recommendations.
The guideline also checks a box in the FDA labeling that mandated agreement between cardiology and neurology in patient selection. The American Academy of Neurology (AAN) issued its own guideline in 2020 for patients with stroke and PFO. In Europe, the European Society of Cardiology issued two position papers on expanded applications of PFO closure.
The recommendations on when PFO closure shouldn’t be done are noteworthy, Dr. Kavinsky said. “PFOs are present in 25% of the adult population, so the number of patients with PFO is huge and the indication for the FDA is really narrow: to reduce the risk of recurrent stroke in patients with PFO-mediated stroke. So, there’s the tremendous potential for abuse out there, of excessive procedures, of doing unnecessary procedures.”
The guidelines are a follow-up to the operator institutional requirements document SCAI issued in 2019 that set requirements for hospital offering and physicians performing PFO closure, Dr. Kavinsky added.
In an editorial accompanying the published guideline, Robert J. Sommer, MD, and Jamil A. Aboulhosn, MD, wrote that they support the recommendations “which help spotlight and clarify the growing list of potential indications for PFO closure.” They noted that the guidelines panel’s “strong” recommendations were for indications validated by randomized trials and that “conditional” recommendations were based on panelists’ experience and observational data.
“It is critical to recognize that most of these guidelines represent consensus opinion only,” wrote Dr. Sommer, who specializes in adult congenital and pediatric cardiology at Columbia University Irving Medical Center, New York, and Dr. Aboulhosn, an interventional cardiologist at Ronald Reagan University of California, Los Angeles, Medical Center. They emphasized the guidelines’ “heavy emphasis” on shared decisionmaking with patients.
Dr. Kavinsky is a principal investigator for Edwards Lifesciences, W.L. Gore and Associates, Medtronic, and Abbott. Dr. Sommer is a principal investigator and investigator in studies sponsored by W.L. Gore & Associates. Dr. Aboulhosn is a consultant to Abbott Medical.
The first-ever guidelines for interventional cardiologists using percutaneous patent foramen ovale closure recommend expanding the use of the procedure beyond the Food and Drug Administration–approved indication following PFO-associated ischemic stroke, adding clarification about the use of PFO with anticoagulation and hedging against abuse and overuse of the procedure, said the chair of the guideline writing committee.
“The most important things surrounding these guidelines are to help clinicians and policymakers – third-party payers – to address PFO in patient subsets that were not included in the large randomized clinical trials that led to FDA approval,” said writing group chair Clifford J. Kavinsky, MD, PhD, chief of structural and interventional cardiology at Rush University Medical Center, Chicago.
The Society for Cardiovascular Angiography & Interventions issued the guidelines at its annual scientific sessions meeting in Atlanta and published them simultaneously in the society’s journal.
The guidelines issue strong and conditional recommendations. The former means clinicians should order the intervention for most patients; the latter means decisionmaking is more nuanced and should consider contributing factors.
The guidelines clarify patient selection for PFO closure outside the “pretty narrow” indication the FDA approved, Dr. Kavinsky said, which is for PFO-associated ischemic stroke in patients aged 18-60 years.
“So what about patients who are older than 60? What about patients who had their stroke 10 years ago?” Dr. Kavinsky asked. “Those are issues that were unanswered in the randomized clinical trials.”
The guidelines also refine recommendations about anticoagulation in these patients, including its use after PFO closure in selected patients, Dr. Kavinsky noted. “It’s the opinion of the panel that although anticoagulants may be effective, because of issues of noncompliance, because of issues of interruption of therapy by physicians for a variety of reasons, including surgery or noncompliance, that it is preferable to do a PFO device closure to giving anticoagulant therapy.”
Many of the recommendations cover PFO closure alongside antiplatelet or anticoagulation therapy. Key conditional recommendations for patients who haven’t had a PFO-related stroke are:
- Avoiding its routine use in patients with chronic migraines, prior decompression illness (DCI), thrombophilia, atrial septal aneurysm, transient ischemic attack (TIA), or deep vein thrombosis (DVT).
- Considering PFO closure in patients with platypnea-orthodeoxia syndrome (POS) with no other discernible cause of hypoxia or systemic embolism in whom other embolic causes have been ruled out.
In patients who’ve had a PFO-related stroke, the guidelines strongly recommend PFO closure versus antiplatelet therapy alone, but conditionally, not in patients with atrial fibrillation who’ve had an ischemic stroke. They also conditionally suggest PFO closure rather than long-term antiplatelet therapy alone in PFO stroke patients aged 60 and older, as well as those with thrombophilia already on antiplatelet therapy but not anticoagulation. However, the guidelines make no recommendation on PFO closure based on how much time has passed since the previous stroke.
“Furthermore,” Dr. Kavinsky said, “in patients who require lifelong anticoagulation because of recurrent DVT or recurrent pulmonary emboli or thrombopenia, if they’ve had a PFO-mediated stroke, then it’s our opinion that they should have their PFO closed in addition to taking lifelong anticoagulation because of the same issues of noncompliance and interruption of therapy.” Those are conditional recommendations.
The guideline also checks a box in the FDA labeling that mandated agreement between cardiology and neurology in patient selection. The American Academy of Neurology (AAN) issued its own guideline in 2020 for patients with stroke and PFO. In Europe, the European Society of Cardiology issued two position papers on expanded applications of PFO closure.
The recommendations on when PFO closure shouldn’t be done are noteworthy, Dr. Kavinsky said. “PFOs are present in 25% of the adult population, so the number of patients with PFO is huge and the indication for the FDA is really narrow: to reduce the risk of recurrent stroke in patients with PFO-mediated stroke. So, there’s the tremendous potential for abuse out there, of excessive procedures, of doing unnecessary procedures.”
The guidelines are a follow-up to the operator institutional requirements document SCAI issued in 2019 that set requirements for hospital offering and physicians performing PFO closure, Dr. Kavinsky added.
In an editorial accompanying the published guideline, Robert J. Sommer, MD, and Jamil A. Aboulhosn, MD, wrote that they support the recommendations “which help spotlight and clarify the growing list of potential indications for PFO closure.” They noted that the guidelines panel’s “strong” recommendations were for indications validated by randomized trials and that “conditional” recommendations were based on panelists’ experience and observational data.
“It is critical to recognize that most of these guidelines represent consensus opinion only,” wrote Dr. Sommer, who specializes in adult congenital and pediatric cardiology at Columbia University Irving Medical Center, New York, and Dr. Aboulhosn, an interventional cardiologist at Ronald Reagan University of California, Los Angeles, Medical Center. They emphasized the guidelines’ “heavy emphasis” on shared decisionmaking with patients.
Dr. Kavinsky is a principal investigator for Edwards Lifesciences, W.L. Gore and Associates, Medtronic, and Abbott. Dr. Sommer is a principal investigator and investigator in studies sponsored by W.L. Gore & Associates. Dr. Aboulhosn is a consultant to Abbott Medical.
The first-ever guidelines for interventional cardiologists using percutaneous patent foramen ovale closure recommend expanding the use of the procedure beyond the Food and Drug Administration–approved indication following PFO-associated ischemic stroke, adding clarification about the use of PFO with anticoagulation and hedging against abuse and overuse of the procedure, said the chair of the guideline writing committee.
“The most important things surrounding these guidelines are to help clinicians and policymakers – third-party payers – to address PFO in patient subsets that were not included in the large randomized clinical trials that led to FDA approval,” said writing group chair Clifford J. Kavinsky, MD, PhD, chief of structural and interventional cardiology at Rush University Medical Center, Chicago.
The Society for Cardiovascular Angiography & Interventions issued the guidelines at its annual scientific sessions meeting in Atlanta and published them simultaneously in the society’s journal.
The guidelines issue strong and conditional recommendations. The former means clinicians should order the intervention for most patients; the latter means decisionmaking is more nuanced and should consider contributing factors.
The guidelines clarify patient selection for PFO closure outside the “pretty narrow” indication the FDA approved, Dr. Kavinsky said, which is for PFO-associated ischemic stroke in patients aged 18-60 years.
“So what about patients who are older than 60? What about patients who had their stroke 10 years ago?” Dr. Kavinsky asked. “Those are issues that were unanswered in the randomized clinical trials.”
The guidelines also refine recommendations about anticoagulation in these patients, including its use after PFO closure in selected patients, Dr. Kavinsky noted. “It’s the opinion of the panel that although anticoagulants may be effective, because of issues of noncompliance, because of issues of interruption of therapy by physicians for a variety of reasons, including surgery or noncompliance, that it is preferable to do a PFO device closure to giving anticoagulant therapy.”
Many of the recommendations cover PFO closure alongside antiplatelet or anticoagulation therapy. Key conditional recommendations for patients who haven’t had a PFO-related stroke are:
- Avoiding its routine use in patients with chronic migraines, prior decompression illness (DCI), thrombophilia, atrial septal aneurysm, transient ischemic attack (TIA), or deep vein thrombosis (DVT).
- Considering PFO closure in patients with platypnea-orthodeoxia syndrome (POS) with no other discernible cause of hypoxia or systemic embolism in whom other embolic causes have been ruled out.
In patients who’ve had a PFO-related stroke, the guidelines strongly recommend PFO closure versus antiplatelet therapy alone, but conditionally, not in patients with atrial fibrillation who’ve had an ischemic stroke. They also conditionally suggest PFO closure rather than long-term antiplatelet therapy alone in PFO stroke patients aged 60 and older, as well as those with thrombophilia already on antiplatelet therapy but not anticoagulation. However, the guidelines make no recommendation on PFO closure based on how much time has passed since the previous stroke.
“Furthermore,” Dr. Kavinsky said, “in patients who require lifelong anticoagulation because of recurrent DVT or recurrent pulmonary emboli or thrombopenia, if they’ve had a PFO-mediated stroke, then it’s our opinion that they should have their PFO closed in addition to taking lifelong anticoagulation because of the same issues of noncompliance and interruption of therapy.” Those are conditional recommendations.
The guideline also checks a box in the FDA labeling that mandated agreement between cardiology and neurology in patient selection. The American Academy of Neurology (AAN) issued its own guideline in 2020 for patients with stroke and PFO. In Europe, the European Society of Cardiology issued two position papers on expanded applications of PFO closure.
The recommendations on when PFO closure shouldn’t be done are noteworthy, Dr. Kavinsky said. “PFOs are present in 25% of the adult population, so the number of patients with PFO is huge and the indication for the FDA is really narrow: to reduce the risk of recurrent stroke in patients with PFO-mediated stroke. So, there’s the tremendous potential for abuse out there, of excessive procedures, of doing unnecessary procedures.”
The guidelines are a follow-up to the operator institutional requirements document SCAI issued in 2019 that set requirements for hospital offering and physicians performing PFO closure, Dr. Kavinsky added.
In an editorial accompanying the published guideline, Robert J. Sommer, MD, and Jamil A. Aboulhosn, MD, wrote that they support the recommendations “which help spotlight and clarify the growing list of potential indications for PFO closure.” They noted that the guidelines panel’s “strong” recommendations were for indications validated by randomized trials and that “conditional” recommendations were based on panelists’ experience and observational data.
“It is critical to recognize that most of these guidelines represent consensus opinion only,” wrote Dr. Sommer, who specializes in adult congenital and pediatric cardiology at Columbia University Irving Medical Center, New York, and Dr. Aboulhosn, an interventional cardiologist at Ronald Reagan University of California, Los Angeles, Medical Center. They emphasized the guidelines’ “heavy emphasis” on shared decisionmaking with patients.
Dr. Kavinsky is a principal investigator for Edwards Lifesciences, W.L. Gore and Associates, Medtronic, and Abbott. Dr. Sommer is a principal investigator and investigator in studies sponsored by W.L. Gore & Associates. Dr. Aboulhosn is a consultant to Abbott Medical.
FROM SCAI 2022
Updated AHA/ASA guideline changes care for spontaneous intracerebral hemorrhage
Many strategies widely considered “standard care” for managing spontaneous intracerebral hemorrhage (ICH) are not as effective as previously thought and are no longer recommended in updated guidelines from the American Heart Association/American Stroke Association (ASA).
Compression stockings, antiseizure medication, and steroid treatment are among the treatments with uncertain effectiveness, the writing group says.
The 2022 Guideline for the Management of Patients With Spontaneous ICH was published online in Stroke. The 80-page document contains major changes and refinements to the 2015 guideline on ICH management.
“Advances have been made in an array of fields related to ICH, including the organization of regional health care systems, reversal of the negative effects of blood thinners, minimally invasive surgical procedures, and the underlying disease in small blood vessels,” Steven M. Greenberg, MD, PhD, chair of the guideline writing group with Harvard Medical School and Massachusetts General Hospital, both in Boston, said in a news release.
“We’ve updated sections across the board. There’s probably no area that went untouched with some tweaking and new evidence added that led to some changes in level of evidence or strength of a recommendation,” Dr. Greenberg added in an interview with this news organization.
“Each section comes with knowledge gaps, and it wasn’t hard to come up with knowledge gaps in every section,” Dr. Greenberg acknowledged.
Time-honored treatments no more?
Among the key updates are changes to some “time-honored” treatments that continue to be used with some “regularity” for patients with ICH, yet appear to confer either no benefit or harm, Dr. Greenberg said.
For example, for emergency or critical care treatment of ICH, prophylactic corticosteroids or continuous hyperosmolar therapy is not recommended, because it appears to have no benefit for outcome, while use of platelet transfusions outside the setting of emergency surgery or severe thrombocytopenia appears to worsen outcome, the authors say.
Use of graduated knee- or thigh-high compression stockings alone is not an effective prophylactic therapy for prevention of deep vein thrombosis (DVT). Instead, intermittent pneumatic compression (IPC) starting on the day of diagnosis is now recommended for DVT prophylaxis.
“This is an area where we still have a lot of exploration to do. It is unclear whether even specialized compression devices reduce the risks of deep vein thrombosis or improve the overall health of people with a brain bleed,” Dr. Greenberg said in the release.
The new guidance advises against use of antiseizure or antidepressant medications for ICH patients in whom there is no evidence of seizures or depression.
In clinical trials, antiseizure medication did not contribute to improvements in functionality or long-term seizure control, and the use of antidepressants increased the chance of bone fractures, the authors say.
The guideline also provides updated recommendations for acute reversal of anticoagulation after ICH. It highlights the use of protein complex concentrate for reversal of vitamin K antagonists, such as warfarin; idarucizumab for reversal of the thrombin inhibitor dabigatran; and andexanet alfa for reversal of factor Xa inhibitors, such as rivaroxaban, apixaban, and edoxaban.
For acute blood pressure lowering after mild to moderate ICH, treatment regimens that limit blood pressure variability and achieve smooth, sustained blood pressure control appear to reduce hematoma expansion and yield better functional outcome, the guideline says.
It also notes that minimally invasive approaches for hematoma evacuation, compared with medical management alone‚ have been shown to reduce mortality.
For patients with cerebellar hemorrhage, indications for immediate surgical evacuation with or without an external ventricular drain to reduce mortality now include larger volume (> 15 mL) in addition to previously recommended indications of neurologic deterioration, brainstem compression, and hydrocephalus, the authors note.
However, a “major knowledge gap is whether we can improve functional outcome with hematoma evacuation,” Dr. Greenberg said.
Multidisciplinary care
For rehabilitation after ICH, the guideline reinforces the importance of having a multidisciplinary team to develop a comprehensive plan for recovery.
Starting rehabilitation activities such as stretching and functional task training may be considered 24 to 48 hours following mild or moderate ICH. However, early aggressive mobilization within the first 24 hours has been linked to an increased risk of death within 14 days after an ICH, the guideline says.
Knowledge gaps include how soon it’s safe to return to work, drive, and participate in other social engagements. Recommendations on sexual activity and exercise levels that are safe after a stroke are also needed.
“People need additional help with these lifestyle changes, whether it’s moving around more, curbing their alcohol use, or eating healthier foods. This all happens after they leave the hospital, and we need to be sure we are empowering families with the information they may need to be properly supportive,” Dr. Greenberg says in the release.
The guideline points to the patient’s home caregiver as a “key and sometimes overlooked” member of the care team. It recommends psychosocial education, practical support, and training for the caregiver to improve the patient’s balance, activity level, and overall quality of life.
Opportunity for prevention?
The guideline also suggests there may be an opportunity to prevent ICH in some people through neuroimaging markers.
While neuroimaging is not routinely performed as a part of risk stratification for primary ICH risk, damage to small blood vessels that is associated with ICH may be evident on MRI that could signal future ICH risk, the guideline says.
“We added to the guidelines for the first time a section on mostly imaging markers of risk for having a first-ever hemorrhage,” Dr. Greenberg said in an interview.
“We don’t make any recommendations as to how to act on these markers because there is a knowledge gap. The hope is that we’ll see growth in our ability to predict first-ever hemorrhage and be able to do things to prevent first-ever hemorrhage,” he said.
“We believe the wide range of knowledge set forth in the new guideline will translate into meaningful improvements in ICH care,” Dr. Greenberg adds in the release.
The updated guideline has been endorsed by the American Association of Neurological Surgeons and Congress of Neurological Surgeons, the Society of Vascular and Interventional Neurology, and the Neurocritical Care Society. The American Academy of Neurology has affirmed the value of this statement as an educational tool for neurologists.
This research had no commercial funding. Dr. Greenberg has disclosed no relevant financial relationships. A complete list of disclosures for the guideline group is available with the original article.
A version of this article first appeared on Medscape.com.
Many strategies widely considered “standard care” for managing spontaneous intracerebral hemorrhage (ICH) are not as effective as previously thought and are no longer recommended in updated guidelines from the American Heart Association/American Stroke Association (ASA).
Compression stockings, antiseizure medication, and steroid treatment are among the treatments with uncertain effectiveness, the writing group says.
The 2022 Guideline for the Management of Patients With Spontaneous ICH was published online in Stroke. The 80-page document contains major changes and refinements to the 2015 guideline on ICH management.
“Advances have been made in an array of fields related to ICH, including the organization of regional health care systems, reversal of the negative effects of blood thinners, minimally invasive surgical procedures, and the underlying disease in small blood vessels,” Steven M. Greenberg, MD, PhD, chair of the guideline writing group with Harvard Medical School and Massachusetts General Hospital, both in Boston, said in a news release.
“We’ve updated sections across the board. There’s probably no area that went untouched with some tweaking and new evidence added that led to some changes in level of evidence or strength of a recommendation,” Dr. Greenberg added in an interview with this news organization.
“Each section comes with knowledge gaps, and it wasn’t hard to come up with knowledge gaps in every section,” Dr. Greenberg acknowledged.
Time-honored treatments no more?
Among the key updates are changes to some “time-honored” treatments that continue to be used with some “regularity” for patients with ICH, yet appear to confer either no benefit or harm, Dr. Greenberg said.
For example, for emergency or critical care treatment of ICH, prophylactic corticosteroids or continuous hyperosmolar therapy is not recommended, because it appears to have no benefit for outcome, while use of platelet transfusions outside the setting of emergency surgery or severe thrombocytopenia appears to worsen outcome, the authors say.
Use of graduated knee- or thigh-high compression stockings alone is not an effective prophylactic therapy for prevention of deep vein thrombosis (DVT). Instead, intermittent pneumatic compression (IPC) starting on the day of diagnosis is now recommended for DVT prophylaxis.
“This is an area where we still have a lot of exploration to do. It is unclear whether even specialized compression devices reduce the risks of deep vein thrombosis or improve the overall health of people with a brain bleed,” Dr. Greenberg said in the release.
The new guidance advises against use of antiseizure or antidepressant medications for ICH patients in whom there is no evidence of seizures or depression.
In clinical trials, antiseizure medication did not contribute to improvements in functionality or long-term seizure control, and the use of antidepressants increased the chance of bone fractures, the authors say.
The guideline also provides updated recommendations for acute reversal of anticoagulation after ICH. It highlights the use of protein complex concentrate for reversal of vitamin K antagonists, such as warfarin; idarucizumab for reversal of the thrombin inhibitor dabigatran; and andexanet alfa for reversal of factor Xa inhibitors, such as rivaroxaban, apixaban, and edoxaban.
For acute blood pressure lowering after mild to moderate ICH, treatment regimens that limit blood pressure variability and achieve smooth, sustained blood pressure control appear to reduce hematoma expansion and yield better functional outcome, the guideline says.
It also notes that minimally invasive approaches for hematoma evacuation, compared with medical management alone‚ have been shown to reduce mortality.
For patients with cerebellar hemorrhage, indications for immediate surgical evacuation with or without an external ventricular drain to reduce mortality now include larger volume (> 15 mL) in addition to previously recommended indications of neurologic deterioration, brainstem compression, and hydrocephalus, the authors note.
However, a “major knowledge gap is whether we can improve functional outcome with hematoma evacuation,” Dr. Greenberg said.
Multidisciplinary care
For rehabilitation after ICH, the guideline reinforces the importance of having a multidisciplinary team to develop a comprehensive plan for recovery.
Starting rehabilitation activities such as stretching and functional task training may be considered 24 to 48 hours following mild or moderate ICH. However, early aggressive mobilization within the first 24 hours has been linked to an increased risk of death within 14 days after an ICH, the guideline says.
Knowledge gaps include how soon it’s safe to return to work, drive, and participate in other social engagements. Recommendations on sexual activity and exercise levels that are safe after a stroke are also needed.
“People need additional help with these lifestyle changes, whether it’s moving around more, curbing their alcohol use, or eating healthier foods. This all happens after they leave the hospital, and we need to be sure we are empowering families with the information they may need to be properly supportive,” Dr. Greenberg says in the release.
The guideline points to the patient’s home caregiver as a “key and sometimes overlooked” member of the care team. It recommends psychosocial education, practical support, and training for the caregiver to improve the patient’s balance, activity level, and overall quality of life.
Opportunity for prevention?
The guideline also suggests there may be an opportunity to prevent ICH in some people through neuroimaging markers.
While neuroimaging is not routinely performed as a part of risk stratification for primary ICH risk, damage to small blood vessels that is associated with ICH may be evident on MRI that could signal future ICH risk, the guideline says.
“We added to the guidelines for the first time a section on mostly imaging markers of risk for having a first-ever hemorrhage,” Dr. Greenberg said in an interview.
“We don’t make any recommendations as to how to act on these markers because there is a knowledge gap. The hope is that we’ll see growth in our ability to predict first-ever hemorrhage and be able to do things to prevent first-ever hemorrhage,” he said.
“We believe the wide range of knowledge set forth in the new guideline will translate into meaningful improvements in ICH care,” Dr. Greenberg adds in the release.
The updated guideline has been endorsed by the American Association of Neurological Surgeons and Congress of Neurological Surgeons, the Society of Vascular and Interventional Neurology, and the Neurocritical Care Society. The American Academy of Neurology has affirmed the value of this statement as an educational tool for neurologists.
This research had no commercial funding. Dr. Greenberg has disclosed no relevant financial relationships. A complete list of disclosures for the guideline group is available with the original article.
A version of this article first appeared on Medscape.com.
Many strategies widely considered “standard care” for managing spontaneous intracerebral hemorrhage (ICH) are not as effective as previously thought and are no longer recommended in updated guidelines from the American Heart Association/American Stroke Association (ASA).
Compression stockings, antiseizure medication, and steroid treatment are among the treatments with uncertain effectiveness, the writing group says.
The 2022 Guideline for the Management of Patients With Spontaneous ICH was published online in Stroke. The 80-page document contains major changes and refinements to the 2015 guideline on ICH management.
“Advances have been made in an array of fields related to ICH, including the organization of regional health care systems, reversal of the negative effects of blood thinners, minimally invasive surgical procedures, and the underlying disease in small blood vessels,” Steven M. Greenberg, MD, PhD, chair of the guideline writing group with Harvard Medical School and Massachusetts General Hospital, both in Boston, said in a news release.
“We’ve updated sections across the board. There’s probably no area that went untouched with some tweaking and new evidence added that led to some changes in level of evidence or strength of a recommendation,” Dr. Greenberg added in an interview with this news organization.
“Each section comes with knowledge gaps, and it wasn’t hard to come up with knowledge gaps in every section,” Dr. Greenberg acknowledged.
Time-honored treatments no more?
Among the key updates are changes to some “time-honored” treatments that continue to be used with some “regularity” for patients with ICH, yet appear to confer either no benefit or harm, Dr. Greenberg said.
For example, for emergency or critical care treatment of ICH, prophylactic corticosteroids or continuous hyperosmolar therapy is not recommended, because it appears to have no benefit for outcome, while use of platelet transfusions outside the setting of emergency surgery or severe thrombocytopenia appears to worsen outcome, the authors say.
Use of graduated knee- or thigh-high compression stockings alone is not an effective prophylactic therapy for prevention of deep vein thrombosis (DVT). Instead, intermittent pneumatic compression (IPC) starting on the day of diagnosis is now recommended for DVT prophylaxis.
“This is an area where we still have a lot of exploration to do. It is unclear whether even specialized compression devices reduce the risks of deep vein thrombosis or improve the overall health of people with a brain bleed,” Dr. Greenberg said in the release.
The new guidance advises against use of antiseizure or antidepressant medications for ICH patients in whom there is no evidence of seizures or depression.
In clinical trials, antiseizure medication did not contribute to improvements in functionality or long-term seizure control, and the use of antidepressants increased the chance of bone fractures, the authors say.
The guideline also provides updated recommendations for acute reversal of anticoagulation after ICH. It highlights the use of protein complex concentrate for reversal of vitamin K antagonists, such as warfarin; idarucizumab for reversal of the thrombin inhibitor dabigatran; and andexanet alfa for reversal of factor Xa inhibitors, such as rivaroxaban, apixaban, and edoxaban.
For acute blood pressure lowering after mild to moderate ICH, treatment regimens that limit blood pressure variability and achieve smooth, sustained blood pressure control appear to reduce hematoma expansion and yield better functional outcome, the guideline says.
It also notes that minimally invasive approaches for hematoma evacuation, compared with medical management alone‚ have been shown to reduce mortality.
For patients with cerebellar hemorrhage, indications for immediate surgical evacuation with or without an external ventricular drain to reduce mortality now include larger volume (> 15 mL) in addition to previously recommended indications of neurologic deterioration, brainstem compression, and hydrocephalus, the authors note.
However, a “major knowledge gap is whether we can improve functional outcome with hematoma evacuation,” Dr. Greenberg said.
Multidisciplinary care
For rehabilitation after ICH, the guideline reinforces the importance of having a multidisciplinary team to develop a comprehensive plan for recovery.
Starting rehabilitation activities such as stretching and functional task training may be considered 24 to 48 hours following mild or moderate ICH. However, early aggressive mobilization within the first 24 hours has been linked to an increased risk of death within 14 days after an ICH, the guideline says.
Knowledge gaps include how soon it’s safe to return to work, drive, and participate in other social engagements. Recommendations on sexual activity and exercise levels that are safe after a stroke are also needed.
“People need additional help with these lifestyle changes, whether it’s moving around more, curbing their alcohol use, or eating healthier foods. This all happens after they leave the hospital, and we need to be sure we are empowering families with the information they may need to be properly supportive,” Dr. Greenberg says in the release.
The guideline points to the patient’s home caregiver as a “key and sometimes overlooked” member of the care team. It recommends psychosocial education, practical support, and training for the caregiver to improve the patient’s balance, activity level, and overall quality of life.
Opportunity for prevention?
The guideline also suggests there may be an opportunity to prevent ICH in some people through neuroimaging markers.
While neuroimaging is not routinely performed as a part of risk stratification for primary ICH risk, damage to small blood vessels that is associated with ICH may be evident on MRI that could signal future ICH risk, the guideline says.
“We added to the guidelines for the first time a section on mostly imaging markers of risk for having a first-ever hemorrhage,” Dr. Greenberg said in an interview.
“We don’t make any recommendations as to how to act on these markers because there is a knowledge gap. The hope is that we’ll see growth in our ability to predict first-ever hemorrhage and be able to do things to prevent first-ever hemorrhage,” he said.
“We believe the wide range of knowledge set forth in the new guideline will translate into meaningful improvements in ICH care,” Dr. Greenberg adds in the release.
The updated guideline has been endorsed by the American Association of Neurological Surgeons and Congress of Neurological Surgeons, the Society of Vascular and Interventional Neurology, and the Neurocritical Care Society. The American Academy of Neurology has affirmed the value of this statement as an educational tool for neurologists.
This research had no commercial funding. Dr. Greenberg has disclosed no relevant financial relationships. A complete list of disclosures for the guideline group is available with the original article.
A version of this article first appeared on Medscape.com.