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Serious arrhythmias playing video games ‘extremely rare’
provided their condition is properly treated, say researchers based on their large, single-center study.
Among more than 3,000 patients in the study with such a genetic vulnerability, just 6 – or less than 0.2% – experienced an electronic gaming–associated cardiac event.
A previous study had concluded that e-gaming, particularly with war games, might trigger potentially fatal arrhythmias in some vulnerable children. That study “sparked controversy in the field, with both clinicians and patients wondering whether electronic gaming is safe for patients with GHDs,” Michael J. Ackerman, MD, PhD, of Mayo Clinic in Rochester, Minn., said in an interview.
Dr. Ackerman and colleagues conducted the current study, published online in the Journal of the American College of Cardiology, to determine just how often e-gaming triggered cardiac events (CE) in these patients – and who was most at risk.
‘Extremely low’ risk
The investigators looked at records from all patients evaluated and treated at the Mayo Clinic’s genetic heart rhythm clinic from 2000 to 2022. They identified those with a history of playing electronic games at the time of their CE, defined here as such an event occurring before diagnosis, or breakthrough cardiac event (BCE), meaning an event occurring after diagnosis.
A total of 3,370 patients with a GHD (55% female) were included in the analysis. More than half (52%) were diagnosed with long-QT syndrome (LQTS). The remainder had various GHDs including, among others, catecholaminergic polymorphic ventricular tachycardia (CPVT) or hypertrophic cardiomyopathy (HCM).
The mean age at first evaluation was 27; 14% of the participants were age 6 or younger, 33% were age 7-20, and 53% were 21 or older. Most patients in each of the three age groups were diagnosed with either LQTS or CPVT.
Of the 3,370 GHD patients, 1,079 (32%) had a CE before diagnosis.
Six patients (0.5%) had a CE in the setting of e-gaming, including five for whom it was the sentinel CE. Five also had CEs in settings not involving e-gaming. Their average age at the time of the CE was 13.
Three of the six patients were diagnosed with CPVT (including two CPVT1 and one CPVT2). Of the others, one was diagnosed with LQT1, one with ventricular fibrillation triggered by premature ventricular contractions, and one with catecholamine-sensitive right ventricular outflow tract ventricular tachycardia (RVOT-VT).
After appropriate treatment, none of the six experienced a BCE during follow-ups ranging from 7 months to 4 years.
Among the full cohort of 3370 patients with GHD, 431 (13%) experienced one or more BCE during follow-up. Of those, one with catecholamine-sensitive RVOT-VT experienced an e-gaming–associated BCE.
“Although anecdotal e-gaming–associated cardiac events, including [sudden cardiac death], have been reported, the absolute risk is extremely low,” the authors wrote.
“Although there are no clear health benefits associated with e-gaming,” Dr. Ackerman said, “the risk of sudden death should not be used as an argument in an effort to curtail the amount of time patients spend e-gaming.”
Furthermore, he added, e-gaming is important to some patients’ quality of life. If patients are “properly diagnosed, risk stratified, and treated, it is okay to engage in e-gaming.”
However, “given that e-gaming may pose some risks, especially when compounded with additional factors such as dehydration, sleep deprivation, and use of performance-enhancing substances such as energy drinks, patients need to be counseled on the potential adverse health consequences,” Dr. Ackerman said.
“To this end,” he added, “we are proponents of incorporating e-gaming status into the clinical evaluation and electronic health record.”
“We would continue to urge common sense and individual risk assessment, with shared decision-making, for those where this may be an issue,” Claire M. Lawley, MBBS, PhD, Children’s Hospital at Westmead (Australia), said in an interview.
“Additionally, syncope during electronic gaming should prompt medical review,” said Dr. Lawley, lead author of the study that prompted Ackerman and colleagues to investigate the issue further.
Buddy system
Maully J. Shah, MBBS, led a study published in 2020 focusing on two case reports of syncope and potentially life-threatening ventricular arrhythmias provoked by emotional surges during play with violent video games.
Nevertheless, “we do not restrict patients from participating in e-games,” Dr. Shah, a pediatric cardiac electrophysiologist at the Cardiac Center at Children’s Hospital of Philadelphia, said in an interview. “We inform them about the available data regarding the very rare but possible occurrence of an event from e-gaming so that they can make an informed decision.”
Dr. Shah agreed that, “even in children not known to have a cardiac condition, syncope associated with emotional responses during violent video games should prompt cardiac evaluation, similar to exercise-induced syncope.”
If a patient wishes to play e-games, clinicians should ensure medication compliance and recommend a “buddy” system. “Don’t be alone while playing,” she said.
“The present study and previous reports make one pause to think whether these CEs and catecholaminergic drives can occur with sports only. If we now consider electronic gaming as a potential risk, what other activities need to be included?” wrote the authors of an accompanying editorial, led by Shankar Baskar, MD, Cincinnati Children’s Medical Center.
“A catecholaminergic drive can occur in many settings with activities of daily living or activities not considered to be competitive,” the editorialists wrote. “Ultimately these events [are] rare, but they can have life-threatening consequences, and at the same time they might not be altogether preventable and, as in electronic gaming, might be an activity that improves quality of life, especially in those who might be restricted from other sports.”
Dr. Ackerman disclosed consulting for Abbott, Boston Scientific, Bristol-Myers Squibb, Daiichi Sankyo, Invitae, Medtronic, Tenaya Therapeutics, and UpToDate. Dr. Ackerman and the Mayo Clinic have license agreements with AliveCor, Anumana, ARMGO Pharma, Pfizer, and Thryv Therapeutics. The other coauthors reported no relevant relationships. Dr. Baskar and colleagues reported no relevant relationships. Dr. Shah disclosed she is a consultant to Medtronic.
A version of this article first appeared on Medscape.com.
provided their condition is properly treated, say researchers based on their large, single-center study.
Among more than 3,000 patients in the study with such a genetic vulnerability, just 6 – or less than 0.2% – experienced an electronic gaming–associated cardiac event.
A previous study had concluded that e-gaming, particularly with war games, might trigger potentially fatal arrhythmias in some vulnerable children. That study “sparked controversy in the field, with both clinicians and patients wondering whether electronic gaming is safe for patients with GHDs,” Michael J. Ackerman, MD, PhD, of Mayo Clinic in Rochester, Minn., said in an interview.
Dr. Ackerman and colleagues conducted the current study, published online in the Journal of the American College of Cardiology, to determine just how often e-gaming triggered cardiac events (CE) in these patients – and who was most at risk.
‘Extremely low’ risk
The investigators looked at records from all patients evaluated and treated at the Mayo Clinic’s genetic heart rhythm clinic from 2000 to 2022. They identified those with a history of playing electronic games at the time of their CE, defined here as such an event occurring before diagnosis, or breakthrough cardiac event (BCE), meaning an event occurring after diagnosis.
A total of 3,370 patients with a GHD (55% female) were included in the analysis. More than half (52%) were diagnosed with long-QT syndrome (LQTS). The remainder had various GHDs including, among others, catecholaminergic polymorphic ventricular tachycardia (CPVT) or hypertrophic cardiomyopathy (HCM).
The mean age at first evaluation was 27; 14% of the participants were age 6 or younger, 33% were age 7-20, and 53% were 21 or older. Most patients in each of the three age groups were diagnosed with either LQTS or CPVT.
Of the 3,370 GHD patients, 1,079 (32%) had a CE before diagnosis.
Six patients (0.5%) had a CE in the setting of e-gaming, including five for whom it was the sentinel CE. Five also had CEs in settings not involving e-gaming. Their average age at the time of the CE was 13.
Three of the six patients were diagnosed with CPVT (including two CPVT1 and one CPVT2). Of the others, one was diagnosed with LQT1, one with ventricular fibrillation triggered by premature ventricular contractions, and one with catecholamine-sensitive right ventricular outflow tract ventricular tachycardia (RVOT-VT).
After appropriate treatment, none of the six experienced a BCE during follow-ups ranging from 7 months to 4 years.
Among the full cohort of 3370 patients with GHD, 431 (13%) experienced one or more BCE during follow-up. Of those, one with catecholamine-sensitive RVOT-VT experienced an e-gaming–associated BCE.
“Although anecdotal e-gaming–associated cardiac events, including [sudden cardiac death], have been reported, the absolute risk is extremely low,” the authors wrote.
“Although there are no clear health benefits associated with e-gaming,” Dr. Ackerman said, “the risk of sudden death should not be used as an argument in an effort to curtail the amount of time patients spend e-gaming.”
Furthermore, he added, e-gaming is important to some patients’ quality of life. If patients are “properly diagnosed, risk stratified, and treated, it is okay to engage in e-gaming.”
However, “given that e-gaming may pose some risks, especially when compounded with additional factors such as dehydration, sleep deprivation, and use of performance-enhancing substances such as energy drinks, patients need to be counseled on the potential adverse health consequences,” Dr. Ackerman said.
“To this end,” he added, “we are proponents of incorporating e-gaming status into the clinical evaluation and electronic health record.”
“We would continue to urge common sense and individual risk assessment, with shared decision-making, for those where this may be an issue,” Claire M. Lawley, MBBS, PhD, Children’s Hospital at Westmead (Australia), said in an interview.
“Additionally, syncope during electronic gaming should prompt medical review,” said Dr. Lawley, lead author of the study that prompted Ackerman and colleagues to investigate the issue further.
Buddy system
Maully J. Shah, MBBS, led a study published in 2020 focusing on two case reports of syncope and potentially life-threatening ventricular arrhythmias provoked by emotional surges during play with violent video games.
Nevertheless, “we do not restrict patients from participating in e-games,” Dr. Shah, a pediatric cardiac electrophysiologist at the Cardiac Center at Children’s Hospital of Philadelphia, said in an interview. “We inform them about the available data regarding the very rare but possible occurrence of an event from e-gaming so that they can make an informed decision.”
Dr. Shah agreed that, “even in children not known to have a cardiac condition, syncope associated with emotional responses during violent video games should prompt cardiac evaluation, similar to exercise-induced syncope.”
If a patient wishes to play e-games, clinicians should ensure medication compliance and recommend a “buddy” system. “Don’t be alone while playing,” she said.
“The present study and previous reports make one pause to think whether these CEs and catecholaminergic drives can occur with sports only. If we now consider electronic gaming as a potential risk, what other activities need to be included?” wrote the authors of an accompanying editorial, led by Shankar Baskar, MD, Cincinnati Children’s Medical Center.
“A catecholaminergic drive can occur in many settings with activities of daily living or activities not considered to be competitive,” the editorialists wrote. “Ultimately these events [are] rare, but they can have life-threatening consequences, and at the same time they might not be altogether preventable and, as in electronic gaming, might be an activity that improves quality of life, especially in those who might be restricted from other sports.”
Dr. Ackerman disclosed consulting for Abbott, Boston Scientific, Bristol-Myers Squibb, Daiichi Sankyo, Invitae, Medtronic, Tenaya Therapeutics, and UpToDate. Dr. Ackerman and the Mayo Clinic have license agreements with AliveCor, Anumana, ARMGO Pharma, Pfizer, and Thryv Therapeutics. The other coauthors reported no relevant relationships. Dr. Baskar and colleagues reported no relevant relationships. Dr. Shah disclosed she is a consultant to Medtronic.
A version of this article first appeared on Medscape.com.
provided their condition is properly treated, say researchers based on their large, single-center study.
Among more than 3,000 patients in the study with such a genetic vulnerability, just 6 – or less than 0.2% – experienced an electronic gaming–associated cardiac event.
A previous study had concluded that e-gaming, particularly with war games, might trigger potentially fatal arrhythmias in some vulnerable children. That study “sparked controversy in the field, with both clinicians and patients wondering whether electronic gaming is safe for patients with GHDs,” Michael J. Ackerman, MD, PhD, of Mayo Clinic in Rochester, Minn., said in an interview.
Dr. Ackerman and colleagues conducted the current study, published online in the Journal of the American College of Cardiology, to determine just how often e-gaming triggered cardiac events (CE) in these patients – and who was most at risk.
‘Extremely low’ risk
The investigators looked at records from all patients evaluated and treated at the Mayo Clinic’s genetic heart rhythm clinic from 2000 to 2022. They identified those with a history of playing electronic games at the time of their CE, defined here as such an event occurring before diagnosis, or breakthrough cardiac event (BCE), meaning an event occurring after diagnosis.
A total of 3,370 patients with a GHD (55% female) were included in the analysis. More than half (52%) were diagnosed with long-QT syndrome (LQTS). The remainder had various GHDs including, among others, catecholaminergic polymorphic ventricular tachycardia (CPVT) or hypertrophic cardiomyopathy (HCM).
The mean age at first evaluation was 27; 14% of the participants were age 6 or younger, 33% were age 7-20, and 53% were 21 or older. Most patients in each of the three age groups were diagnosed with either LQTS or CPVT.
Of the 3,370 GHD patients, 1,079 (32%) had a CE before diagnosis.
Six patients (0.5%) had a CE in the setting of e-gaming, including five for whom it was the sentinel CE. Five also had CEs in settings not involving e-gaming. Their average age at the time of the CE was 13.
Three of the six patients were diagnosed with CPVT (including two CPVT1 and one CPVT2). Of the others, one was diagnosed with LQT1, one with ventricular fibrillation triggered by premature ventricular contractions, and one with catecholamine-sensitive right ventricular outflow tract ventricular tachycardia (RVOT-VT).
After appropriate treatment, none of the six experienced a BCE during follow-ups ranging from 7 months to 4 years.
Among the full cohort of 3370 patients with GHD, 431 (13%) experienced one or more BCE during follow-up. Of those, one with catecholamine-sensitive RVOT-VT experienced an e-gaming–associated BCE.
“Although anecdotal e-gaming–associated cardiac events, including [sudden cardiac death], have been reported, the absolute risk is extremely low,” the authors wrote.
“Although there are no clear health benefits associated with e-gaming,” Dr. Ackerman said, “the risk of sudden death should not be used as an argument in an effort to curtail the amount of time patients spend e-gaming.”
Furthermore, he added, e-gaming is important to some patients’ quality of life. If patients are “properly diagnosed, risk stratified, and treated, it is okay to engage in e-gaming.”
However, “given that e-gaming may pose some risks, especially when compounded with additional factors such as dehydration, sleep deprivation, and use of performance-enhancing substances such as energy drinks, patients need to be counseled on the potential adverse health consequences,” Dr. Ackerman said.
“To this end,” he added, “we are proponents of incorporating e-gaming status into the clinical evaluation and electronic health record.”
“We would continue to urge common sense and individual risk assessment, with shared decision-making, for those where this may be an issue,” Claire M. Lawley, MBBS, PhD, Children’s Hospital at Westmead (Australia), said in an interview.
“Additionally, syncope during electronic gaming should prompt medical review,” said Dr. Lawley, lead author of the study that prompted Ackerman and colleagues to investigate the issue further.
Buddy system
Maully J. Shah, MBBS, led a study published in 2020 focusing on two case reports of syncope and potentially life-threatening ventricular arrhythmias provoked by emotional surges during play with violent video games.
Nevertheless, “we do not restrict patients from participating in e-games,” Dr. Shah, a pediatric cardiac electrophysiologist at the Cardiac Center at Children’s Hospital of Philadelphia, said in an interview. “We inform them about the available data regarding the very rare but possible occurrence of an event from e-gaming so that they can make an informed decision.”
Dr. Shah agreed that, “even in children not known to have a cardiac condition, syncope associated with emotional responses during violent video games should prompt cardiac evaluation, similar to exercise-induced syncope.”
If a patient wishes to play e-games, clinicians should ensure medication compliance and recommend a “buddy” system. “Don’t be alone while playing,” she said.
“The present study and previous reports make one pause to think whether these CEs and catecholaminergic drives can occur with sports only. If we now consider electronic gaming as a potential risk, what other activities need to be included?” wrote the authors of an accompanying editorial, led by Shankar Baskar, MD, Cincinnati Children’s Medical Center.
“A catecholaminergic drive can occur in many settings with activities of daily living or activities not considered to be competitive,” the editorialists wrote. “Ultimately these events [are] rare, but they can have life-threatening consequences, and at the same time they might not be altogether preventable and, as in electronic gaming, might be an activity that improves quality of life, especially in those who might be restricted from other sports.”
Dr. Ackerman disclosed consulting for Abbott, Boston Scientific, Bristol-Myers Squibb, Daiichi Sankyo, Invitae, Medtronic, Tenaya Therapeutics, and UpToDate. Dr. Ackerman and the Mayo Clinic have license agreements with AliveCor, Anumana, ARMGO Pharma, Pfizer, and Thryv Therapeutics. The other coauthors reported no relevant relationships. Dr. Baskar and colleagues reported no relevant relationships. Dr. Shah disclosed she is a consultant to Medtronic.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
One size doesn’t fit all in blood pressure measurement
As with porridge, so with blood pressure: Just right makes all the difference.
according to research published in JAMA Internal Medicine.
People whose mid-upper arm circumference exceeds 32 cm require larger cuffs than the standard size, but in many cases the regular-sized cuff is used on everyone. As a result, patients with larger arms may be falsely diagnosed with high blood pressure because of a too-small cuff, leading to overprescribing of medications that could make their health worse, according to the researchers.
“A person whose blood pressure is 120/80, which is normal – if they’re using the wrong cuff, they could get a measurement that says 140/90, let’s say,” said study author Tammy M. Brady, MD, PhD, vice chair for clinical research in the department of pediatrics at Johns Hopkins University, Baltimore. “They might think they not only have hypertension, but stage 2 hypertension. Providers might give one or even two medicines to lower this, which could lead to hypotension,” Dr. Brady said.
Conversely, someone with smaller arms whose cuff is too big may present with an artificially low blood pressure. The implications of using ill-fitting cuffs are well known. Dr. Brady, among others, has studied the topic extensively. Even so, she said the measurement errors in the latest study were larger than expected.
The Goldilocks test
People with an arm circumference of 20-25 cm should use a smaller cuff than the regular size, Dr. Brady and colleagues reported. Circumferences of 25.1-32 cm require a regular-sized cuff; large cuffs are for circumferences of 32.1-40 cm; and extra-large cuffs should be used at 40.1-55 cm.
The study included 195 residents of Baltimore (128 women, 67 men; 132 Black, 58 White, 5 Hispanic) with an average age of 54 years. The researchers measured every participant’s blood pressure using an automated device on four occasions, taking three measurements each time.
The first three sets of measurements used, respectively, an appropriate cuff size for each person’s arm circumference; a cuff that was too big; and a cuff that was too small. This study design ensured that a regular-sized cuff would be used during one of the three measurements – sometimes that cuff was too small, sometimes it was appropriate, and other times it was too big.
The final set of three measurements used the appropriate cuff size for a person’s arm every time. Dr. Brady and colleagues then compared people’s blood pressure measurements when using the right-sized cuff to measurements with a regular-sized cuff that was not suited for them.
They found that using a cuff that was too large for the patient’s arm (i.e., using a regular cuff when a small cuff was the right choice) led to understating systolic blood pressure by –3.6 mm Hg (95% confidence interval [CI], –5.6 to –1.7). A cuff that was one size too small – using regular instead of a large – overestimated systolic blood pressure by 4.8 (3.0-6.6) mm Hg. And a cuff that was two sizes too small – someone who should have received an extra-large cuff but received the regular size – overestimated systolic blood pressure by 19.5 (16.1-22.9) mm Hg. All differences were statistically significant, the researchers reported.
“To our knowledge, this is the first randomized cross-over trial to examine the effect of miscuffing on automated blood pressure readings,” Mathias Lalika, MD, MPH, of the Mayo Clinic in Rochester, Minn.; Stephen P. Juraschek, MD, PhD, of Beth Israel Deaconess Medical Center in Boston; and LaPrincess C. Brewer, MD, MPH, of the Mayo Clinic, wrote in an editorial accompanying the journal article.
“Interestingly, the degree of underestimation or overestimation increased as the appropriate cuff size progressed from the regular to extra-large BP cuff. More importantly, the effect of miscuffing did not vary with BP or obesity status,” they wrote.
“This was more of a pragmatic trial to see real world, all comers,” Dr. Brady said, when regular-sized cuffs are used whether or not that made sense.
“This study reaffirms findings of previous studies and highlights a major source of error in blood pressure measurement,” Raj Padwal, MD, director of the University of Alberta Hypertension Clinic, Edmonton, Alta., said in an interview. Dr. Padwal, who was not involved in the study, said the findings highlight the importance of ensuring that technicians who typically measure blood pressure understand the value of using the right-sized cuff.
Dr. Brady noted that measuring arm circumference takes about 15 seconds. He advised health organizations and clinics to carry multiple cuffs sizes to avoid a scramble to find a right-sized cuff. In the editorial, Dr. Lalika, Dr. Juraschek, and Dr. Brewer call for particular attention to providing the right-sized cuffs to facilities that work with underserved populations, such as federally qualified health centers.
Dr. Padwal added that even a perfectly measured blood pressure test at a clinic indicates pressure at a moment in time. Ten minutes later the story could be different. For this reason, he and other clinicians recommend frequent home blood pressure measurements rather than relying solely on the sparse number of readings collected in the clinic setting.
“A properly educated patient can give many readings that are separated in space and time and, when averaged, can give a much better picture of overall blood pressure and future risk,” Dr. Padwal said.
Dr. Brady agreed with the value of home readings but said home-based readings also can be erroneous if the patient uses a cuff that is the wrong size. She cochairs a committee for the American Medical Association that recommends validated home blood pressure measurement devices on a periodically updated website called Validate BP. The details for each device listing show the cuff sizes available per device. Many devices provide only the standard cuff, Dr. Brady noted, but some offer multiple cuff sizes.
“One of the things that would be great if it came out of this paper is if patients were empowered to ask physicians to measure their arm” and then use that information to select the appropriate cuff for their home device, she said.
Dr. Brady and Dr. Padwal reported no relevant financial relationships. This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill & Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation.
A version of this article appeared on Medscape.com.
As with porridge, so with blood pressure: Just right makes all the difference.
according to research published in JAMA Internal Medicine.
People whose mid-upper arm circumference exceeds 32 cm require larger cuffs than the standard size, but in many cases the regular-sized cuff is used on everyone. As a result, patients with larger arms may be falsely diagnosed with high blood pressure because of a too-small cuff, leading to overprescribing of medications that could make their health worse, according to the researchers.
“A person whose blood pressure is 120/80, which is normal – if they’re using the wrong cuff, they could get a measurement that says 140/90, let’s say,” said study author Tammy M. Brady, MD, PhD, vice chair for clinical research in the department of pediatrics at Johns Hopkins University, Baltimore. “They might think they not only have hypertension, but stage 2 hypertension. Providers might give one or even two medicines to lower this, which could lead to hypotension,” Dr. Brady said.
Conversely, someone with smaller arms whose cuff is too big may present with an artificially low blood pressure. The implications of using ill-fitting cuffs are well known. Dr. Brady, among others, has studied the topic extensively. Even so, she said the measurement errors in the latest study were larger than expected.
The Goldilocks test
People with an arm circumference of 20-25 cm should use a smaller cuff than the regular size, Dr. Brady and colleagues reported. Circumferences of 25.1-32 cm require a regular-sized cuff; large cuffs are for circumferences of 32.1-40 cm; and extra-large cuffs should be used at 40.1-55 cm.
The study included 195 residents of Baltimore (128 women, 67 men; 132 Black, 58 White, 5 Hispanic) with an average age of 54 years. The researchers measured every participant’s blood pressure using an automated device on four occasions, taking three measurements each time.
The first three sets of measurements used, respectively, an appropriate cuff size for each person’s arm circumference; a cuff that was too big; and a cuff that was too small. This study design ensured that a regular-sized cuff would be used during one of the three measurements – sometimes that cuff was too small, sometimes it was appropriate, and other times it was too big.
The final set of three measurements used the appropriate cuff size for a person’s arm every time. Dr. Brady and colleagues then compared people’s blood pressure measurements when using the right-sized cuff to measurements with a regular-sized cuff that was not suited for them.
They found that using a cuff that was too large for the patient’s arm (i.e., using a regular cuff when a small cuff was the right choice) led to understating systolic blood pressure by –3.6 mm Hg (95% confidence interval [CI], –5.6 to –1.7). A cuff that was one size too small – using regular instead of a large – overestimated systolic blood pressure by 4.8 (3.0-6.6) mm Hg. And a cuff that was two sizes too small – someone who should have received an extra-large cuff but received the regular size – overestimated systolic blood pressure by 19.5 (16.1-22.9) mm Hg. All differences were statistically significant, the researchers reported.
“To our knowledge, this is the first randomized cross-over trial to examine the effect of miscuffing on automated blood pressure readings,” Mathias Lalika, MD, MPH, of the Mayo Clinic in Rochester, Minn.; Stephen P. Juraschek, MD, PhD, of Beth Israel Deaconess Medical Center in Boston; and LaPrincess C. Brewer, MD, MPH, of the Mayo Clinic, wrote in an editorial accompanying the journal article.
“Interestingly, the degree of underestimation or overestimation increased as the appropriate cuff size progressed from the regular to extra-large BP cuff. More importantly, the effect of miscuffing did not vary with BP or obesity status,” they wrote.
“This was more of a pragmatic trial to see real world, all comers,” Dr. Brady said, when regular-sized cuffs are used whether or not that made sense.
“This study reaffirms findings of previous studies and highlights a major source of error in blood pressure measurement,” Raj Padwal, MD, director of the University of Alberta Hypertension Clinic, Edmonton, Alta., said in an interview. Dr. Padwal, who was not involved in the study, said the findings highlight the importance of ensuring that technicians who typically measure blood pressure understand the value of using the right-sized cuff.
Dr. Brady noted that measuring arm circumference takes about 15 seconds. He advised health organizations and clinics to carry multiple cuffs sizes to avoid a scramble to find a right-sized cuff. In the editorial, Dr. Lalika, Dr. Juraschek, and Dr. Brewer call for particular attention to providing the right-sized cuffs to facilities that work with underserved populations, such as federally qualified health centers.
Dr. Padwal added that even a perfectly measured blood pressure test at a clinic indicates pressure at a moment in time. Ten minutes later the story could be different. For this reason, he and other clinicians recommend frequent home blood pressure measurements rather than relying solely on the sparse number of readings collected in the clinic setting.
“A properly educated patient can give many readings that are separated in space and time and, when averaged, can give a much better picture of overall blood pressure and future risk,” Dr. Padwal said.
Dr. Brady agreed with the value of home readings but said home-based readings also can be erroneous if the patient uses a cuff that is the wrong size. She cochairs a committee for the American Medical Association that recommends validated home blood pressure measurement devices on a periodically updated website called Validate BP. The details for each device listing show the cuff sizes available per device. Many devices provide only the standard cuff, Dr. Brady noted, but some offer multiple cuff sizes.
“One of the things that would be great if it came out of this paper is if patients were empowered to ask physicians to measure their arm” and then use that information to select the appropriate cuff for their home device, she said.
Dr. Brady and Dr. Padwal reported no relevant financial relationships. This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill & Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation.
A version of this article appeared on Medscape.com.
As with porridge, so with blood pressure: Just right makes all the difference.
according to research published in JAMA Internal Medicine.
People whose mid-upper arm circumference exceeds 32 cm require larger cuffs than the standard size, but in many cases the regular-sized cuff is used on everyone. As a result, patients with larger arms may be falsely diagnosed with high blood pressure because of a too-small cuff, leading to overprescribing of medications that could make their health worse, according to the researchers.
“A person whose blood pressure is 120/80, which is normal – if they’re using the wrong cuff, they could get a measurement that says 140/90, let’s say,” said study author Tammy M. Brady, MD, PhD, vice chair for clinical research in the department of pediatrics at Johns Hopkins University, Baltimore. “They might think they not only have hypertension, but stage 2 hypertension. Providers might give one or even two medicines to lower this, which could lead to hypotension,” Dr. Brady said.
Conversely, someone with smaller arms whose cuff is too big may present with an artificially low blood pressure. The implications of using ill-fitting cuffs are well known. Dr. Brady, among others, has studied the topic extensively. Even so, she said the measurement errors in the latest study were larger than expected.
The Goldilocks test
People with an arm circumference of 20-25 cm should use a smaller cuff than the regular size, Dr. Brady and colleagues reported. Circumferences of 25.1-32 cm require a regular-sized cuff; large cuffs are for circumferences of 32.1-40 cm; and extra-large cuffs should be used at 40.1-55 cm.
The study included 195 residents of Baltimore (128 women, 67 men; 132 Black, 58 White, 5 Hispanic) with an average age of 54 years. The researchers measured every participant’s blood pressure using an automated device on four occasions, taking three measurements each time.
The first three sets of measurements used, respectively, an appropriate cuff size for each person’s arm circumference; a cuff that was too big; and a cuff that was too small. This study design ensured that a regular-sized cuff would be used during one of the three measurements – sometimes that cuff was too small, sometimes it was appropriate, and other times it was too big.
The final set of three measurements used the appropriate cuff size for a person’s arm every time. Dr. Brady and colleagues then compared people’s blood pressure measurements when using the right-sized cuff to measurements with a regular-sized cuff that was not suited for them.
They found that using a cuff that was too large for the patient’s arm (i.e., using a regular cuff when a small cuff was the right choice) led to understating systolic blood pressure by –3.6 mm Hg (95% confidence interval [CI], –5.6 to –1.7). A cuff that was one size too small – using regular instead of a large – overestimated systolic blood pressure by 4.8 (3.0-6.6) mm Hg. And a cuff that was two sizes too small – someone who should have received an extra-large cuff but received the regular size – overestimated systolic blood pressure by 19.5 (16.1-22.9) mm Hg. All differences were statistically significant, the researchers reported.
“To our knowledge, this is the first randomized cross-over trial to examine the effect of miscuffing on automated blood pressure readings,” Mathias Lalika, MD, MPH, of the Mayo Clinic in Rochester, Minn.; Stephen P. Juraschek, MD, PhD, of Beth Israel Deaconess Medical Center in Boston; and LaPrincess C. Brewer, MD, MPH, of the Mayo Clinic, wrote in an editorial accompanying the journal article.
“Interestingly, the degree of underestimation or overestimation increased as the appropriate cuff size progressed from the regular to extra-large BP cuff. More importantly, the effect of miscuffing did not vary with BP or obesity status,” they wrote.
“This was more of a pragmatic trial to see real world, all comers,” Dr. Brady said, when regular-sized cuffs are used whether or not that made sense.
“This study reaffirms findings of previous studies and highlights a major source of error in blood pressure measurement,” Raj Padwal, MD, director of the University of Alberta Hypertension Clinic, Edmonton, Alta., said in an interview. Dr. Padwal, who was not involved in the study, said the findings highlight the importance of ensuring that technicians who typically measure blood pressure understand the value of using the right-sized cuff.
Dr. Brady noted that measuring arm circumference takes about 15 seconds. He advised health organizations and clinics to carry multiple cuffs sizes to avoid a scramble to find a right-sized cuff. In the editorial, Dr. Lalika, Dr. Juraschek, and Dr. Brewer call for particular attention to providing the right-sized cuffs to facilities that work with underserved populations, such as federally qualified health centers.
Dr. Padwal added that even a perfectly measured blood pressure test at a clinic indicates pressure at a moment in time. Ten minutes later the story could be different. For this reason, he and other clinicians recommend frequent home blood pressure measurements rather than relying solely on the sparse number of readings collected in the clinic setting.
“A properly educated patient can give many readings that are separated in space and time and, when averaged, can give a much better picture of overall blood pressure and future risk,” Dr. Padwal said.
Dr. Brady agreed with the value of home readings but said home-based readings also can be erroneous if the patient uses a cuff that is the wrong size. She cochairs a committee for the American Medical Association that recommends validated home blood pressure measurement devices on a periodically updated website called Validate BP. The details for each device listing show the cuff sizes available per device. Many devices provide only the standard cuff, Dr. Brady noted, but some offer multiple cuff sizes.
“One of the things that would be great if it came out of this paper is if patients were empowered to ask physicians to measure their arm” and then use that information to select the appropriate cuff for their home device, she said.
Dr. Brady and Dr. Padwal reported no relevant financial relationships. This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill & Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation.
A version of this article appeared on Medscape.com.
FROM JAMA INTERNAL MEDICINE
Low-dose steroids may not increase cardiovascular risk in rheumatoid arthritis
A daily prednisolone dose of 5 mg or higher is associated with increased risk for major adverse cardiovascular events (MACE) among patients with rheumatoid arthritis (RA), data suggest. Patients taking daily doses below this threshold did not appear to have an increased risk of MACE, compared with those not taking glucocorticoids (GCs).
Other studies of GCs and CV risk among RA patients have yielded conflicting results, especially for low-dose GCs. Findings from a 2020 study published in PLOS Medicine suggested that patients who had several immune-mediated inflammatory diseases – including RA – and who took less than a 5-mg prednisolone-equivalent dose daily had 74% higher risk for all-cause CVD, compared with nonusers. But results from a 2021 study published in Annals of the Rheumatic Diseases suggested that a daily prednisone dose of 4 mg or less did not increase cardiovascular events over a period of 6 months to 1 year.
These contradictory results were “primarily due to incomplete control of confounding variables, such as failure to adjust for C-reactive protein (CRP) levels,” Dr. Tam said. “Our study aimed to use a big data analytical approach to determine the effect of systemic GC dose and duration on the risk of major adverse cardiovascular events in patients with RA, while controlling for systemic inflammation, traditional CV risk factors, and other therapies.”
Is there a ‘safe’ dose for glucocorticoids?
To analyze this relationship, Dr. Lam and colleagues used the Hospital Authority Data Collaboration Laboratory, a citywide health care database. The investigators recruited patients with RA who had no history of MACE from 2006 to 2015 and followed them until the end of 2018. The primary outcome was the first occurrence of a MACE, defined as a composite of myocardial infarction (MI), unstable angina, ischemic or hemorrhagic cerebrovascular accident, transient ischemic attack, and CV death.
The study was published in Annals of the Rheumatic Diseases.
The analysis included 12,233 patients with RA and had over 105,826 person-years of follow-up. The average follow-up time was 8.7 years. During the study period, 860 patients had their first MACE. After controlling for confounding factors, a daily prednisolone dose of 5 mg or higher doubled the risk for MACE, compared with GC nonusers. MACE risk increased by 7% per month.
Long-term glucocorticoid use discouraged
Daily doses of less than 5 mg were not associated with higher MACE risk, but more research is necessary to understand whether these low doses are clinically efficacious, Dr. Tam said. “The study results suggest that a very-low-dose GC (less than 5 mg prednisolone daily) may be cardiovascular risk–neutral. However, further evaluation is needed to determine whether this dose is therapeutic. Other potential side effects, such as bone loss, increased infection risk, dyslipidemia, and hyperglycemia, should also be considered.”
Both the American College of Rheumatology and the European Alliance of Associations for Rheumatology acknowledge that short-term GCs may be necessary for some RA patients, but they emphasize using the smallest necessary dose for the shortest period possible because of the known toxicity of GCs.
“We recommend stopping GCs as soon as it is clinically feasible, in line with previous recommendations, until these issues are investigated further,” Dr. Tam added.
Dr. Bartels agreed that long-term use of GCs should be avoided if possible, even at lower doses, because although CV risk may be less of an issue, studies have shown an increased risk for infection even at GC doses of less than 5 mg a day.
How might risk increase with dose?
While the study showed a distinct difference in risk with doses of prednisolone higher and lower than 5 mg, more information on how risk increases with dose could be useful, said Beth Wallace, MD, an assistant professor in internal medicine at the University of Michigan, Ann Arbor, and a staff rheumatologist at the VA Ann Arbor Healthcare Center. She was also unaffiliated with the research. “If someone is on 5-10 mg ... how much better is that than being on 10-20 mg or being on 20-30 mg?” she asked. While these study findings are “very important,” she said, it would be useful to know the risk associated with 7.5 mg vs. a higher dose.
But even in this relatively healthy population in Hong Kong, “taking more than 5 mg of prednisolone doubles the risk of cardiovascular disease,” Dr. Wallace added. This is important for clinicians to know, especially if they are more cautious about prescribing steroids to older or sicker patients but are “using [the drugs] a little more indiscriminately in younger people and healthier people.”
The study did not receive outside funding. Dr. Tam and Dr. Bartels report no relevant financial relationships. Dr. Wallace has received a grant from the Department of Veterans Affairs Administration to study steroid tapering in RA.
A version of this article first appeared on Medscape.com.
A daily prednisolone dose of 5 mg or higher is associated with increased risk for major adverse cardiovascular events (MACE) among patients with rheumatoid arthritis (RA), data suggest. Patients taking daily doses below this threshold did not appear to have an increased risk of MACE, compared with those not taking glucocorticoids (GCs).
Other studies of GCs and CV risk among RA patients have yielded conflicting results, especially for low-dose GCs. Findings from a 2020 study published in PLOS Medicine suggested that patients who had several immune-mediated inflammatory diseases – including RA – and who took less than a 5-mg prednisolone-equivalent dose daily had 74% higher risk for all-cause CVD, compared with nonusers. But results from a 2021 study published in Annals of the Rheumatic Diseases suggested that a daily prednisone dose of 4 mg or less did not increase cardiovascular events over a period of 6 months to 1 year.
These contradictory results were “primarily due to incomplete control of confounding variables, such as failure to adjust for C-reactive protein (CRP) levels,” Dr. Tam said. “Our study aimed to use a big data analytical approach to determine the effect of systemic GC dose and duration on the risk of major adverse cardiovascular events in patients with RA, while controlling for systemic inflammation, traditional CV risk factors, and other therapies.”
Is there a ‘safe’ dose for glucocorticoids?
To analyze this relationship, Dr. Lam and colleagues used the Hospital Authority Data Collaboration Laboratory, a citywide health care database. The investigators recruited patients with RA who had no history of MACE from 2006 to 2015 and followed them until the end of 2018. The primary outcome was the first occurrence of a MACE, defined as a composite of myocardial infarction (MI), unstable angina, ischemic or hemorrhagic cerebrovascular accident, transient ischemic attack, and CV death.
The study was published in Annals of the Rheumatic Diseases.
The analysis included 12,233 patients with RA and had over 105,826 person-years of follow-up. The average follow-up time was 8.7 years. During the study period, 860 patients had their first MACE. After controlling for confounding factors, a daily prednisolone dose of 5 mg or higher doubled the risk for MACE, compared with GC nonusers. MACE risk increased by 7% per month.
Long-term glucocorticoid use discouraged
Daily doses of less than 5 mg were not associated with higher MACE risk, but more research is necessary to understand whether these low doses are clinically efficacious, Dr. Tam said. “The study results suggest that a very-low-dose GC (less than 5 mg prednisolone daily) may be cardiovascular risk–neutral. However, further evaluation is needed to determine whether this dose is therapeutic. Other potential side effects, such as bone loss, increased infection risk, dyslipidemia, and hyperglycemia, should also be considered.”
Both the American College of Rheumatology and the European Alliance of Associations for Rheumatology acknowledge that short-term GCs may be necessary for some RA patients, but they emphasize using the smallest necessary dose for the shortest period possible because of the known toxicity of GCs.
“We recommend stopping GCs as soon as it is clinically feasible, in line with previous recommendations, until these issues are investigated further,” Dr. Tam added.
Dr. Bartels agreed that long-term use of GCs should be avoided if possible, even at lower doses, because although CV risk may be less of an issue, studies have shown an increased risk for infection even at GC doses of less than 5 mg a day.
How might risk increase with dose?
While the study showed a distinct difference in risk with doses of prednisolone higher and lower than 5 mg, more information on how risk increases with dose could be useful, said Beth Wallace, MD, an assistant professor in internal medicine at the University of Michigan, Ann Arbor, and a staff rheumatologist at the VA Ann Arbor Healthcare Center. She was also unaffiliated with the research. “If someone is on 5-10 mg ... how much better is that than being on 10-20 mg or being on 20-30 mg?” she asked. While these study findings are “very important,” she said, it would be useful to know the risk associated with 7.5 mg vs. a higher dose.
But even in this relatively healthy population in Hong Kong, “taking more than 5 mg of prednisolone doubles the risk of cardiovascular disease,” Dr. Wallace added. This is important for clinicians to know, especially if they are more cautious about prescribing steroids to older or sicker patients but are “using [the drugs] a little more indiscriminately in younger people and healthier people.”
The study did not receive outside funding. Dr. Tam and Dr. Bartels report no relevant financial relationships. Dr. Wallace has received a grant from the Department of Veterans Affairs Administration to study steroid tapering in RA.
A version of this article first appeared on Medscape.com.
A daily prednisolone dose of 5 mg or higher is associated with increased risk for major adverse cardiovascular events (MACE) among patients with rheumatoid arthritis (RA), data suggest. Patients taking daily doses below this threshold did not appear to have an increased risk of MACE, compared with those not taking glucocorticoids (GCs).
Other studies of GCs and CV risk among RA patients have yielded conflicting results, especially for low-dose GCs. Findings from a 2020 study published in PLOS Medicine suggested that patients who had several immune-mediated inflammatory diseases – including RA – and who took less than a 5-mg prednisolone-equivalent dose daily had 74% higher risk for all-cause CVD, compared with nonusers. But results from a 2021 study published in Annals of the Rheumatic Diseases suggested that a daily prednisone dose of 4 mg or less did not increase cardiovascular events over a period of 6 months to 1 year.
These contradictory results were “primarily due to incomplete control of confounding variables, such as failure to adjust for C-reactive protein (CRP) levels,” Dr. Tam said. “Our study aimed to use a big data analytical approach to determine the effect of systemic GC dose and duration on the risk of major adverse cardiovascular events in patients with RA, while controlling for systemic inflammation, traditional CV risk factors, and other therapies.”
Is there a ‘safe’ dose for glucocorticoids?
To analyze this relationship, Dr. Lam and colleagues used the Hospital Authority Data Collaboration Laboratory, a citywide health care database. The investigators recruited patients with RA who had no history of MACE from 2006 to 2015 and followed them until the end of 2018. The primary outcome was the first occurrence of a MACE, defined as a composite of myocardial infarction (MI), unstable angina, ischemic or hemorrhagic cerebrovascular accident, transient ischemic attack, and CV death.
The study was published in Annals of the Rheumatic Diseases.
The analysis included 12,233 patients with RA and had over 105,826 person-years of follow-up. The average follow-up time was 8.7 years. During the study period, 860 patients had their first MACE. After controlling for confounding factors, a daily prednisolone dose of 5 mg or higher doubled the risk for MACE, compared with GC nonusers. MACE risk increased by 7% per month.
Long-term glucocorticoid use discouraged
Daily doses of less than 5 mg were not associated with higher MACE risk, but more research is necessary to understand whether these low doses are clinically efficacious, Dr. Tam said. “The study results suggest that a very-low-dose GC (less than 5 mg prednisolone daily) may be cardiovascular risk–neutral. However, further evaluation is needed to determine whether this dose is therapeutic. Other potential side effects, such as bone loss, increased infection risk, dyslipidemia, and hyperglycemia, should also be considered.”
Both the American College of Rheumatology and the European Alliance of Associations for Rheumatology acknowledge that short-term GCs may be necessary for some RA patients, but they emphasize using the smallest necessary dose for the shortest period possible because of the known toxicity of GCs.
“We recommend stopping GCs as soon as it is clinically feasible, in line with previous recommendations, until these issues are investigated further,” Dr. Tam added.
Dr. Bartels agreed that long-term use of GCs should be avoided if possible, even at lower doses, because although CV risk may be less of an issue, studies have shown an increased risk for infection even at GC doses of less than 5 mg a day.
How might risk increase with dose?
While the study showed a distinct difference in risk with doses of prednisolone higher and lower than 5 mg, more information on how risk increases with dose could be useful, said Beth Wallace, MD, an assistant professor in internal medicine at the University of Michigan, Ann Arbor, and a staff rheumatologist at the VA Ann Arbor Healthcare Center. She was also unaffiliated with the research. “If someone is on 5-10 mg ... how much better is that than being on 10-20 mg or being on 20-30 mg?” she asked. While these study findings are “very important,” she said, it would be useful to know the risk associated with 7.5 mg vs. a higher dose.
But even in this relatively healthy population in Hong Kong, “taking more than 5 mg of prednisolone doubles the risk of cardiovascular disease,” Dr. Wallace added. This is important for clinicians to know, especially if they are more cautious about prescribing steroids to older or sicker patients but are “using [the drugs] a little more indiscriminately in younger people and healthier people.”
The study did not receive outside funding. Dr. Tam and Dr. Bartels report no relevant financial relationships. Dr. Wallace has received a grant from the Department of Veterans Affairs Administration to study steroid tapering in RA.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF THE RHEUMATIC DISEASES
Obesity cardiomyopathy tied to sudden cardiac death
a new case-control study suggests.
Researchers who analyzed hearts taken at autopsy from people who had died from sudden cardiac death found that a number of the hearts obtained from obese decedents were heavier than those from normal-weight decedents and that the hazard ratio of unexplained cardiomegaly in this cohort was 5.3, compared with normal-weight individuals.
“Even when we ruled out any conditions that could potentially cause enlargement of the heart, including hypertension, heart valve problems, diabetes, and other cardiovascular risk factors, the association with obesity cardiomyopathy, or OCM, and sudden cardiac death remained,” lead author Joseph Westaby, PhD, from the Cardiac Risk in the Young (CRY) Cardiovascular Pathology Laboratories at St George’s University of London, said in an interview.
The study was published online in JACC: Advances.
Intrigued by this finding, Dr. Westaby and associates sought to characterize the clinical and pathological features of OCM associated with sudden cardiac death by comparing this population to two control groups: sudden cardiac death patients who were either obese or of normal weight, and had morphologically normal hearts.
Their group is uniquely positioned to do such research, Dr. Westaby explained.
“Here at St George’s University of London, we have a specialized cardiovascular pathology service. ... All hearts obtained at autopsy from individuals who have died from sudden cardiac death, or who were suspected to have had a cardiovascular cause of death, anywhere in the U.K., are referred to the CRY Centre for further analysis,” he said.
Patients were divided into two groups according to body mass index: an obesity group (BMI > 30 kg/m2) and a normal-weight group (BMI, 18.5-24.9).
An increased heart weight above 550 g in men and 450 g in women in the absence of coronary artery disease, hypertension, diabetes, or valvular disease was classified as unexplained cardiomegaly, and individuals with obesity and cardiomegaly were defined as obesity cardiomyopathy.
Age- and sex-matched controls with obesity (n = 106) were selected based on a BMI greater than 30, with a morphologically normal heart weighing less than 550 g in men and than 450 g in women.
Age- and sex-matched normal weight controls (n = 106) were selected based on a BMI of 18.5-24.9 and a morphologically normal heart weighing less than 550 g in men and less than 450 g in women.
The researchers identified 53 OCM cases from a cohort of more than 4,500 sudden cardiac death cases that had BMI measurements. In normal-weight patients, there were 14 cases of unexplained cardiomegaly.
The mean age at death of individuals with OCM was 42 years (range, 30-54 years). Most of the deaths occurred in men (n = 34; 64%), who also died younger than women (40 ± 13 years vs. 45 ± 10 years; P = .036).
The average heart weight in OCM patients was 598 ± 93 g. Risk of sudden cardiac death increased when BMI reached 35.
Compared with matched controls, there were increases in right and left ventricular wall thickness (all P < .05) in OCM cases. Right ventricular epicardial fat was increased in OCM cases, compared with normal-weight controls only.
Left ventricular fibrosis was identified in seven (13%) OCM cases.
Role of genetics to be explored
“This study highlights the need for further investigation into these individuals because, at the moment, we can’t be sure that the only contributing factor to this is the obesity,” said Dr. Westaby.
In the works are plans to see if there may be an underlying genetic predisposition in obese individuals that may have contributed to the development of an enlarged heart. The group also plans to study the families of the deceased individuals to determine if they are at risk of developing cardiomegaly, he said.
“This paper makes an important contribution to the literature that raises many important questions for future research,” Timothy P. Fitzgibbons, MD, PhD, from the University of Massachusetts, Worcester, wrote in an accompanying editorial.
Being able to access so many autopsy samples gives the current study considerable heft, Dr. Fitzgibbons said in an interview.
“A lot has been made of the obesity paradox and the perhaps benign nature of obesity but this paper suggests the opposite, that it is a very serious problem and can, in fact, in and of itself, cause heart abnormalities that could cause sudden death,” he noted.
The fact that only 13% of OCM cases had fibrosis on histology suggests that fibrosis was not the main cause of sudden cardiac death, he said.
“Often we will do MRIs to look for areas of fibrosis within the heart because those areas make patients prone to re-entry arrhythmias, in particular, ventricular tachycardia. But the authors suggest that the enlarged myocytes may themselves be predisposing to arrhythmias, rather than fibrosis,” Dr. Fitzgibbons said.
The study was supported by Cardiac Risk in the Young. Dr. Westaby and Dr. Fitzgibbons have reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
a new case-control study suggests.
Researchers who analyzed hearts taken at autopsy from people who had died from sudden cardiac death found that a number of the hearts obtained from obese decedents were heavier than those from normal-weight decedents and that the hazard ratio of unexplained cardiomegaly in this cohort was 5.3, compared with normal-weight individuals.
“Even when we ruled out any conditions that could potentially cause enlargement of the heart, including hypertension, heart valve problems, diabetes, and other cardiovascular risk factors, the association with obesity cardiomyopathy, or OCM, and sudden cardiac death remained,” lead author Joseph Westaby, PhD, from the Cardiac Risk in the Young (CRY) Cardiovascular Pathology Laboratories at St George’s University of London, said in an interview.
The study was published online in JACC: Advances.
Intrigued by this finding, Dr. Westaby and associates sought to characterize the clinical and pathological features of OCM associated with sudden cardiac death by comparing this population to two control groups: sudden cardiac death patients who were either obese or of normal weight, and had morphologically normal hearts.
Their group is uniquely positioned to do such research, Dr. Westaby explained.
“Here at St George’s University of London, we have a specialized cardiovascular pathology service. ... All hearts obtained at autopsy from individuals who have died from sudden cardiac death, or who were suspected to have had a cardiovascular cause of death, anywhere in the U.K., are referred to the CRY Centre for further analysis,” he said.
Patients were divided into two groups according to body mass index: an obesity group (BMI > 30 kg/m2) and a normal-weight group (BMI, 18.5-24.9).
An increased heart weight above 550 g in men and 450 g in women in the absence of coronary artery disease, hypertension, diabetes, or valvular disease was classified as unexplained cardiomegaly, and individuals with obesity and cardiomegaly were defined as obesity cardiomyopathy.
Age- and sex-matched controls with obesity (n = 106) were selected based on a BMI greater than 30, with a morphologically normal heart weighing less than 550 g in men and than 450 g in women.
Age- and sex-matched normal weight controls (n = 106) were selected based on a BMI of 18.5-24.9 and a morphologically normal heart weighing less than 550 g in men and less than 450 g in women.
The researchers identified 53 OCM cases from a cohort of more than 4,500 sudden cardiac death cases that had BMI measurements. In normal-weight patients, there were 14 cases of unexplained cardiomegaly.
The mean age at death of individuals with OCM was 42 years (range, 30-54 years). Most of the deaths occurred in men (n = 34; 64%), who also died younger than women (40 ± 13 years vs. 45 ± 10 years; P = .036).
The average heart weight in OCM patients was 598 ± 93 g. Risk of sudden cardiac death increased when BMI reached 35.
Compared with matched controls, there were increases in right and left ventricular wall thickness (all P < .05) in OCM cases. Right ventricular epicardial fat was increased in OCM cases, compared with normal-weight controls only.
Left ventricular fibrosis was identified in seven (13%) OCM cases.
Role of genetics to be explored
“This study highlights the need for further investigation into these individuals because, at the moment, we can’t be sure that the only contributing factor to this is the obesity,” said Dr. Westaby.
In the works are plans to see if there may be an underlying genetic predisposition in obese individuals that may have contributed to the development of an enlarged heart. The group also plans to study the families of the deceased individuals to determine if they are at risk of developing cardiomegaly, he said.
“This paper makes an important contribution to the literature that raises many important questions for future research,” Timothy P. Fitzgibbons, MD, PhD, from the University of Massachusetts, Worcester, wrote in an accompanying editorial.
Being able to access so many autopsy samples gives the current study considerable heft, Dr. Fitzgibbons said in an interview.
“A lot has been made of the obesity paradox and the perhaps benign nature of obesity but this paper suggests the opposite, that it is a very serious problem and can, in fact, in and of itself, cause heart abnormalities that could cause sudden death,” he noted.
The fact that only 13% of OCM cases had fibrosis on histology suggests that fibrosis was not the main cause of sudden cardiac death, he said.
“Often we will do MRIs to look for areas of fibrosis within the heart because those areas make patients prone to re-entry arrhythmias, in particular, ventricular tachycardia. But the authors suggest that the enlarged myocytes may themselves be predisposing to arrhythmias, rather than fibrosis,” Dr. Fitzgibbons said.
The study was supported by Cardiac Risk in the Young. Dr. Westaby and Dr. Fitzgibbons have reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
a new case-control study suggests.
Researchers who analyzed hearts taken at autopsy from people who had died from sudden cardiac death found that a number of the hearts obtained from obese decedents were heavier than those from normal-weight decedents and that the hazard ratio of unexplained cardiomegaly in this cohort was 5.3, compared with normal-weight individuals.
“Even when we ruled out any conditions that could potentially cause enlargement of the heart, including hypertension, heart valve problems, diabetes, and other cardiovascular risk factors, the association with obesity cardiomyopathy, or OCM, and sudden cardiac death remained,” lead author Joseph Westaby, PhD, from the Cardiac Risk in the Young (CRY) Cardiovascular Pathology Laboratories at St George’s University of London, said in an interview.
The study was published online in JACC: Advances.
Intrigued by this finding, Dr. Westaby and associates sought to characterize the clinical and pathological features of OCM associated with sudden cardiac death by comparing this population to two control groups: sudden cardiac death patients who were either obese or of normal weight, and had morphologically normal hearts.
Their group is uniquely positioned to do such research, Dr. Westaby explained.
“Here at St George’s University of London, we have a specialized cardiovascular pathology service. ... All hearts obtained at autopsy from individuals who have died from sudden cardiac death, or who were suspected to have had a cardiovascular cause of death, anywhere in the U.K., are referred to the CRY Centre for further analysis,” he said.
Patients were divided into two groups according to body mass index: an obesity group (BMI > 30 kg/m2) and a normal-weight group (BMI, 18.5-24.9).
An increased heart weight above 550 g in men and 450 g in women in the absence of coronary artery disease, hypertension, diabetes, or valvular disease was classified as unexplained cardiomegaly, and individuals with obesity and cardiomegaly were defined as obesity cardiomyopathy.
Age- and sex-matched controls with obesity (n = 106) were selected based on a BMI greater than 30, with a morphologically normal heart weighing less than 550 g in men and than 450 g in women.
Age- and sex-matched normal weight controls (n = 106) were selected based on a BMI of 18.5-24.9 and a morphologically normal heart weighing less than 550 g in men and less than 450 g in women.
The researchers identified 53 OCM cases from a cohort of more than 4,500 sudden cardiac death cases that had BMI measurements. In normal-weight patients, there were 14 cases of unexplained cardiomegaly.
The mean age at death of individuals with OCM was 42 years (range, 30-54 years). Most of the deaths occurred in men (n = 34; 64%), who also died younger than women (40 ± 13 years vs. 45 ± 10 years; P = .036).
The average heart weight in OCM patients was 598 ± 93 g. Risk of sudden cardiac death increased when BMI reached 35.
Compared with matched controls, there were increases in right and left ventricular wall thickness (all P < .05) in OCM cases. Right ventricular epicardial fat was increased in OCM cases, compared with normal-weight controls only.
Left ventricular fibrosis was identified in seven (13%) OCM cases.
Role of genetics to be explored
“This study highlights the need for further investigation into these individuals because, at the moment, we can’t be sure that the only contributing factor to this is the obesity,” said Dr. Westaby.
In the works are plans to see if there may be an underlying genetic predisposition in obese individuals that may have contributed to the development of an enlarged heart. The group also plans to study the families of the deceased individuals to determine if they are at risk of developing cardiomegaly, he said.
“This paper makes an important contribution to the literature that raises many important questions for future research,” Timothy P. Fitzgibbons, MD, PhD, from the University of Massachusetts, Worcester, wrote in an accompanying editorial.
Being able to access so many autopsy samples gives the current study considerable heft, Dr. Fitzgibbons said in an interview.
“A lot has been made of the obesity paradox and the perhaps benign nature of obesity but this paper suggests the opposite, that it is a very serious problem and can, in fact, in and of itself, cause heart abnormalities that could cause sudden death,” he noted.
The fact that only 13% of OCM cases had fibrosis on histology suggests that fibrosis was not the main cause of sudden cardiac death, he said.
“Often we will do MRIs to look for areas of fibrosis within the heart because those areas make patients prone to re-entry arrhythmias, in particular, ventricular tachycardia. But the authors suggest that the enlarged myocytes may themselves be predisposing to arrhythmias, rather than fibrosis,” Dr. Fitzgibbons said.
The study was supported by Cardiac Risk in the Young. Dr. Westaby and Dr. Fitzgibbons have reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM JACC: ADVANCES
LAAO tied to fewer post-fall bleeds than DOACs in AF
Left atrial appendage occlusion (LAAO) is associated with fewer injuries and less bleeding from falls than anticoagulant medications in patients with atrial fibrillation (AF) and a previous stroke, a new cohort study suggests.
Investigators prospectively followed more than 1,250 patients with AF and a previous ischemic stroke. Approximately half underwent LAAO, while the other half were treated with direct oral anticoagulants (DOACs). Patients were followed for close to 2 years.
Slightly more than 20% of patients fell during that period in each group, and , who were not taking anticoagulants. The risk for a major bleed, including an intracranial bleed, was 70% lower in the LAAO group.
LAAO has previously been considered for people at risk of bleeding events – for example, those with gastrointestinal (GI) bleeds, bruising, or intracranial bleeding – but had not yet been studied in those at risk for falls, coauthor Moussa Mansour, MD, professor of medicine, Harvard Medical School, and director of the Atrial Fibrillation Program at Massachusetts General Hospital, Boston, said in an interview.
This is the first study to focus on LAAO specifically for those at risk for falling and demonstrated that the LAAO has utility in this population as well, which is important because the U.S. population is an aging population, and at advanced ages, “people’s balance becomes unsteady and they are at high risk of falling,” he said.
The findings were published online as a research letter in the Journal of the American College of Cardiology.
Multidisciplinary collaboration
“More than one in five of our neurology patients with AF fall – many with devastating consequences – making stroke prevention extremely challenging,” senior author MingMing Ning, MD, MMsc, associate professor of neurology, Harvard Medical School, and director of the Cardio-Neurology and the Clinical Proteomics Research Center at Massachusetts General Hospital, Boston, said in an interview.
“There is a dire need to tailor treatment to keep our patients safe while preventing future strokes,” she said.
Anticoagulants are effective in stroke prevention in these patients but are associated with a higher risk for major bleeding, especially after a fall.
The current prospective observational study recruited 1,266 stroke patients who were treated either with LAAO or DOACs (n = 570 and 696, respectively). Patients were followed for a median of 1.8 years (IQR: 0.9-3.0).
During the follow-up period, 22.6% of LAAO-treated patients and 22.7% of DOAC-treated patients sustained a fall (mean age 78.9 years, 57.4% male and 79.1 years, 52.5% male respectively).
Fall severity, evaluated via the Injury Severity Score, was less in the LAAO vs. the DOAC group, with ISS scores of 1 (IQR 1-4) vs. 4 (IQR 1.75-9).
LAAO was associated with significantly reduced severity of fall-related injuries (OR, –1.09, 95% confidence interval [CI], –1.52 to –0.66; P < .001) – a finding that remained statistically significant after adjustment for confounders such as age, sex, and comorbidities contributing to fall risk, such as hypertension, hyperlipidemia, and diabetes.
The incidence of major trauma (defined as ISS >15) was lower in the LAAO group, compared to the DOAC group (0.8% vs. 6.3%, respectively, P = .026), and LAAO-treated patients had a shorter length of hospital stay, with fewer LAAO patients compared with DOAC patients staying in the hospital for more than 3 days (17% vs. 29.1%, respectively, P = .018).
The risk for major post-fall bleeding was lower in the LAAO vs. the DOAC group (4.7% vs. 15.2%, AOR, 0.29; 95% CI, 0.11-0.73; P = .009) – a finding that included intracranial bleeding (3.1% vs. 9.5%; AOR, 0.29; 95% CI, 0.09-0.90; P = .033).
“Many people are living to advanced ages, where their balance becomes unsteady, and in addition, we have an increase in the prevalence of AF because people are living longer and it’s a disease of the elderly, because we have more hypertension, and we also have more tools to diagnose AF. It’s almost a ‘perfect storm’ situation, and we need effective interventions in this population,” said Dr. Mansour.
Before the study, people at risk for falling were not being considered for LAAO; but now, “we believe they should be considered,” he added. “And although people in the current study had all experienced an ischemic stroke, any patient at risk of a fall will potentially benefit.”
Beyond demonstrating the role of LAAO in reducing the risk of post-fall bleeding injuries, the study – which was conducted by specialists in neurology and cardiology among other fields – highlights the importance of multidisciplinary collaboration, which is “key” for effective stroke prevention, Dr. Ning said.
She emphasized that “we need to learn from our patients and tailor treatment to their needs. A patient’s risk of falling, lifestyle, and medication adherence are all important for individualizing care and improving quality of life.”
Better option
Commenting for this article, Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said the authors “should be commended for this prospective study on real-world patients that has yielded highly meaningful data from a clinical standpoint.”
Dr. Natale, who was not involved with the study, said it has “several strong points,” such as a fairly large sample size, exclusive population with a history of AF-related stroke, long follow-up duration, evaluation of fall incidents by blinded experts, and severity of fall assessed by a validated questionnaire.
“This is the first study that directly compared the outcomes of traumatic fall in patients receiving LAAO vs. DOAC,” he said. “Given that history of fall is an independent predictor of bleeding and death, the study findings by Deng et al. offer the hope for a safer life with the LAAO option in the aging, fall-prone AF population.”
The take-home message is that, in patients with history of stroke, LAAO “is a better option, in terms of significantly reduced injury severity and shortened hospital length of stay after traumatic falls,” Dr. Natale said.
This study was supported in part by research grants from Boston Scientific, the Leducq Foundation, and the National Institutes of Health. The authors reported no relevant financial relationships. Dr. Natale is a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic.
A version of this article appeared on Medscape.com.
Left atrial appendage occlusion (LAAO) is associated with fewer injuries and less bleeding from falls than anticoagulant medications in patients with atrial fibrillation (AF) and a previous stroke, a new cohort study suggests.
Investigators prospectively followed more than 1,250 patients with AF and a previous ischemic stroke. Approximately half underwent LAAO, while the other half were treated with direct oral anticoagulants (DOACs). Patients were followed for close to 2 years.
Slightly more than 20% of patients fell during that period in each group, and , who were not taking anticoagulants. The risk for a major bleed, including an intracranial bleed, was 70% lower in the LAAO group.
LAAO has previously been considered for people at risk of bleeding events – for example, those with gastrointestinal (GI) bleeds, bruising, or intracranial bleeding – but had not yet been studied in those at risk for falls, coauthor Moussa Mansour, MD, professor of medicine, Harvard Medical School, and director of the Atrial Fibrillation Program at Massachusetts General Hospital, Boston, said in an interview.
This is the first study to focus on LAAO specifically for those at risk for falling and demonstrated that the LAAO has utility in this population as well, which is important because the U.S. population is an aging population, and at advanced ages, “people’s balance becomes unsteady and they are at high risk of falling,” he said.
The findings were published online as a research letter in the Journal of the American College of Cardiology.
Multidisciplinary collaboration
“More than one in five of our neurology patients with AF fall – many with devastating consequences – making stroke prevention extremely challenging,” senior author MingMing Ning, MD, MMsc, associate professor of neurology, Harvard Medical School, and director of the Cardio-Neurology and the Clinical Proteomics Research Center at Massachusetts General Hospital, Boston, said in an interview.
“There is a dire need to tailor treatment to keep our patients safe while preventing future strokes,” she said.
Anticoagulants are effective in stroke prevention in these patients but are associated with a higher risk for major bleeding, especially after a fall.
The current prospective observational study recruited 1,266 stroke patients who were treated either with LAAO or DOACs (n = 570 and 696, respectively). Patients were followed for a median of 1.8 years (IQR: 0.9-3.0).
During the follow-up period, 22.6% of LAAO-treated patients and 22.7% of DOAC-treated patients sustained a fall (mean age 78.9 years, 57.4% male and 79.1 years, 52.5% male respectively).
Fall severity, evaluated via the Injury Severity Score, was less in the LAAO vs. the DOAC group, with ISS scores of 1 (IQR 1-4) vs. 4 (IQR 1.75-9).
LAAO was associated with significantly reduced severity of fall-related injuries (OR, –1.09, 95% confidence interval [CI], –1.52 to –0.66; P < .001) – a finding that remained statistically significant after adjustment for confounders such as age, sex, and comorbidities contributing to fall risk, such as hypertension, hyperlipidemia, and diabetes.
The incidence of major trauma (defined as ISS >15) was lower in the LAAO group, compared to the DOAC group (0.8% vs. 6.3%, respectively, P = .026), and LAAO-treated patients had a shorter length of hospital stay, with fewer LAAO patients compared with DOAC patients staying in the hospital for more than 3 days (17% vs. 29.1%, respectively, P = .018).
The risk for major post-fall bleeding was lower in the LAAO vs. the DOAC group (4.7% vs. 15.2%, AOR, 0.29; 95% CI, 0.11-0.73; P = .009) – a finding that included intracranial bleeding (3.1% vs. 9.5%; AOR, 0.29; 95% CI, 0.09-0.90; P = .033).
“Many people are living to advanced ages, where their balance becomes unsteady, and in addition, we have an increase in the prevalence of AF because people are living longer and it’s a disease of the elderly, because we have more hypertension, and we also have more tools to diagnose AF. It’s almost a ‘perfect storm’ situation, and we need effective interventions in this population,” said Dr. Mansour.
Before the study, people at risk for falling were not being considered for LAAO; but now, “we believe they should be considered,” he added. “And although people in the current study had all experienced an ischemic stroke, any patient at risk of a fall will potentially benefit.”
Beyond demonstrating the role of LAAO in reducing the risk of post-fall bleeding injuries, the study – which was conducted by specialists in neurology and cardiology among other fields – highlights the importance of multidisciplinary collaboration, which is “key” for effective stroke prevention, Dr. Ning said.
She emphasized that “we need to learn from our patients and tailor treatment to their needs. A patient’s risk of falling, lifestyle, and medication adherence are all important for individualizing care and improving quality of life.”
Better option
Commenting for this article, Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said the authors “should be commended for this prospective study on real-world patients that has yielded highly meaningful data from a clinical standpoint.”
Dr. Natale, who was not involved with the study, said it has “several strong points,” such as a fairly large sample size, exclusive population with a history of AF-related stroke, long follow-up duration, evaluation of fall incidents by blinded experts, and severity of fall assessed by a validated questionnaire.
“This is the first study that directly compared the outcomes of traumatic fall in patients receiving LAAO vs. DOAC,” he said. “Given that history of fall is an independent predictor of bleeding and death, the study findings by Deng et al. offer the hope for a safer life with the LAAO option in the aging, fall-prone AF population.”
The take-home message is that, in patients with history of stroke, LAAO “is a better option, in terms of significantly reduced injury severity and shortened hospital length of stay after traumatic falls,” Dr. Natale said.
This study was supported in part by research grants from Boston Scientific, the Leducq Foundation, and the National Institutes of Health. The authors reported no relevant financial relationships. Dr. Natale is a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic.
A version of this article appeared on Medscape.com.
Left atrial appendage occlusion (LAAO) is associated with fewer injuries and less bleeding from falls than anticoagulant medications in patients with atrial fibrillation (AF) and a previous stroke, a new cohort study suggests.
Investigators prospectively followed more than 1,250 patients with AF and a previous ischemic stroke. Approximately half underwent LAAO, while the other half were treated with direct oral anticoagulants (DOACs). Patients were followed for close to 2 years.
Slightly more than 20% of patients fell during that period in each group, and , who were not taking anticoagulants. The risk for a major bleed, including an intracranial bleed, was 70% lower in the LAAO group.
LAAO has previously been considered for people at risk of bleeding events – for example, those with gastrointestinal (GI) bleeds, bruising, or intracranial bleeding – but had not yet been studied in those at risk for falls, coauthor Moussa Mansour, MD, professor of medicine, Harvard Medical School, and director of the Atrial Fibrillation Program at Massachusetts General Hospital, Boston, said in an interview.
This is the first study to focus on LAAO specifically for those at risk for falling and demonstrated that the LAAO has utility in this population as well, which is important because the U.S. population is an aging population, and at advanced ages, “people’s balance becomes unsteady and they are at high risk of falling,” he said.
The findings were published online as a research letter in the Journal of the American College of Cardiology.
Multidisciplinary collaboration
“More than one in five of our neurology patients with AF fall – many with devastating consequences – making stroke prevention extremely challenging,” senior author MingMing Ning, MD, MMsc, associate professor of neurology, Harvard Medical School, and director of the Cardio-Neurology and the Clinical Proteomics Research Center at Massachusetts General Hospital, Boston, said in an interview.
“There is a dire need to tailor treatment to keep our patients safe while preventing future strokes,” she said.
Anticoagulants are effective in stroke prevention in these patients but are associated with a higher risk for major bleeding, especially after a fall.
The current prospective observational study recruited 1,266 stroke patients who were treated either with LAAO or DOACs (n = 570 and 696, respectively). Patients were followed for a median of 1.8 years (IQR: 0.9-3.0).
During the follow-up period, 22.6% of LAAO-treated patients and 22.7% of DOAC-treated patients sustained a fall (mean age 78.9 years, 57.4% male and 79.1 years, 52.5% male respectively).
Fall severity, evaluated via the Injury Severity Score, was less in the LAAO vs. the DOAC group, with ISS scores of 1 (IQR 1-4) vs. 4 (IQR 1.75-9).
LAAO was associated with significantly reduced severity of fall-related injuries (OR, –1.09, 95% confidence interval [CI], –1.52 to –0.66; P < .001) – a finding that remained statistically significant after adjustment for confounders such as age, sex, and comorbidities contributing to fall risk, such as hypertension, hyperlipidemia, and diabetes.
The incidence of major trauma (defined as ISS >15) was lower in the LAAO group, compared to the DOAC group (0.8% vs. 6.3%, respectively, P = .026), and LAAO-treated patients had a shorter length of hospital stay, with fewer LAAO patients compared with DOAC patients staying in the hospital for more than 3 days (17% vs. 29.1%, respectively, P = .018).
The risk for major post-fall bleeding was lower in the LAAO vs. the DOAC group (4.7% vs. 15.2%, AOR, 0.29; 95% CI, 0.11-0.73; P = .009) – a finding that included intracranial bleeding (3.1% vs. 9.5%; AOR, 0.29; 95% CI, 0.09-0.90; P = .033).
“Many people are living to advanced ages, where their balance becomes unsteady, and in addition, we have an increase in the prevalence of AF because people are living longer and it’s a disease of the elderly, because we have more hypertension, and we also have more tools to diagnose AF. It’s almost a ‘perfect storm’ situation, and we need effective interventions in this population,” said Dr. Mansour.
Before the study, people at risk for falling were not being considered for LAAO; but now, “we believe they should be considered,” he added. “And although people in the current study had all experienced an ischemic stroke, any patient at risk of a fall will potentially benefit.”
Beyond demonstrating the role of LAAO in reducing the risk of post-fall bleeding injuries, the study – which was conducted by specialists in neurology and cardiology among other fields – highlights the importance of multidisciplinary collaboration, which is “key” for effective stroke prevention, Dr. Ning said.
She emphasized that “we need to learn from our patients and tailor treatment to their needs. A patient’s risk of falling, lifestyle, and medication adherence are all important for individualizing care and improving quality of life.”
Better option
Commenting for this article, Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said the authors “should be commended for this prospective study on real-world patients that has yielded highly meaningful data from a clinical standpoint.”
Dr. Natale, who was not involved with the study, said it has “several strong points,” such as a fairly large sample size, exclusive population with a history of AF-related stroke, long follow-up duration, evaluation of fall incidents by blinded experts, and severity of fall assessed by a validated questionnaire.
“This is the first study that directly compared the outcomes of traumatic fall in patients receiving LAAO vs. DOAC,” he said. “Given that history of fall is an independent predictor of bleeding and death, the study findings by Deng et al. offer the hope for a safer life with the LAAO option in the aging, fall-prone AF population.”
The take-home message is that, in patients with history of stroke, LAAO “is a better option, in terms of significantly reduced injury severity and shortened hospital length of stay after traumatic falls,” Dr. Natale said.
This study was supported in part by research grants from Boston Scientific, the Leducq Foundation, and the National Institutes of Health. The authors reported no relevant financial relationships. Dr. Natale is a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic.
A version of this article appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Even one drink a day tied to increased BP in healthy adults
“A vexing question has been whether usual intake of small amounts of alcohol is associated with a higher level of BP. We identified a continuous, more or less linear association, with no evidence of a threshold for the association,” study coauthor Paul Whelton, MD, of Tulane University School of Public Health and Tropical Medicine, New Orleans, said in an interview.
For systolic BP (SBP), “the most important BP risk indicator for CVD [cardiovascular disease], the association was robust, being present in both men and women and in both North America as well as Asia,” Dr. Whelton noted.
Based on the results, “the lower the better, and no consumption even better, as we did not find any indication that human health may benefit from consumption of very small amounts of alcohol,” senior author Marco Vinceti, MD, PhD, of University of Modena and Reggio Emilia University in Italy, told this news organization.
“Clearly, alcohol is not the only or necessarily the main determinant of high blood pressure, and the effects of small intakes of alcohol emerging from our pooled analysis were certainly not biologically as relevant and meaningful as those induced by high intakes,” Dr. Vinceti added.
The study was published online in Hypertension.
The researchers analyzed data from seven large, observational studies conducted in the United States, Korea, and Japan involving 19,548 adults (65% men).
Participants ranged in age from 20 years to the early 70s at baseline and were followed for a median of 5.3 years (range, 4-12 years). None of the participants had previously been diagnosed with hypertension or other CVD, diabetes, liver disease, alcoholism, or binge drinking.
Compared with nondrinkers, SBP was 1.25 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 4.90 mm Hg in adults consuming an average of 48 grams of alcohol per day.
For reference, in the United States, 12 ounces of regular beer, 5 ounces of wine, or a 1.5-ounce shot of distilled spirits contains about 14 grams of alcohol.
Diastolic BP (DBP) was 1.14 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 3.10 mm Hg in those who consumed an average of 48 grams of alcohol per day.
Subgroup analyses by gender showed an almost linear association between baseline alcohol intake and SBP changes in men and women and for DBP in men, while in women, there was an inverted U-shaped association.
No safe level
“From a BP perspective, it’s best to avoid alcohol intake. This is what the WHO [World Health Organization] recommends,” Dr. Whelton said.
“If someone is already drinking alcohol and does not want to stop doing so, minimizing alcohol consumption is desirable; many guidelines recommend not starting to drink alcohol but in those already drinking alcohol, consumption of two or less standard drinks per day for men and one or less standard drinks of alcohol per day for women,” Dr. Whelton noted.
Commenting on the study for this article, Alberto Ascherio, MD, of Harvard T. H. Chan School of Public Health, Boston, said it’s been known for more than 30 years that alcohol intake is associated with increased systolic and diastolic BP. The added value of this new study is a “refinement of the estimate of the dose response.”
Dr. Ascherio noted that “moderate alcohol consumption is associated with a modest increase in risk of cancer, but, in spite of the adverse association with BP, with a potentially beneficial effect on cardiovascular disease.” However, “the causality of the latter association has been questioned, but there is no consensus on this.”
Also weighing in, Timothy Brennan, MD, MPH, chief of clinical services for the Addiction Institute of Mount Sinai Health System in New York City, said this new study represents “yet another piece of evidence suggesting that there simply is no ‘healthy’ amount of alcohol use in humans.
“Even small amounts of alcohol intake can have negative health effects, as demonstrated in this study,” Dr. Brennan said. “There is still a widely held belief among people that drinking in moderation is good for you. It is becoming more and more clear that this is simply not the case. As health authorities grapple with drinking ‘recommendations,’ additional datasets like these will be helpful.”
The study had no specific funding. Dr. Whelton, Dr. Vinceti, Dr. Ascherio, and Dr. Brennan have no relevant disclosures.
A version of this article first appeared on Medscape.com.
“A vexing question has been whether usual intake of small amounts of alcohol is associated with a higher level of BP. We identified a continuous, more or less linear association, with no evidence of a threshold for the association,” study coauthor Paul Whelton, MD, of Tulane University School of Public Health and Tropical Medicine, New Orleans, said in an interview.
For systolic BP (SBP), “the most important BP risk indicator for CVD [cardiovascular disease], the association was robust, being present in both men and women and in both North America as well as Asia,” Dr. Whelton noted.
Based on the results, “the lower the better, and no consumption even better, as we did not find any indication that human health may benefit from consumption of very small amounts of alcohol,” senior author Marco Vinceti, MD, PhD, of University of Modena and Reggio Emilia University in Italy, told this news organization.
“Clearly, alcohol is not the only or necessarily the main determinant of high blood pressure, and the effects of small intakes of alcohol emerging from our pooled analysis were certainly not biologically as relevant and meaningful as those induced by high intakes,” Dr. Vinceti added.
The study was published online in Hypertension.
The researchers analyzed data from seven large, observational studies conducted in the United States, Korea, and Japan involving 19,548 adults (65% men).
Participants ranged in age from 20 years to the early 70s at baseline and were followed for a median of 5.3 years (range, 4-12 years). None of the participants had previously been diagnosed with hypertension or other CVD, diabetes, liver disease, alcoholism, or binge drinking.
Compared with nondrinkers, SBP was 1.25 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 4.90 mm Hg in adults consuming an average of 48 grams of alcohol per day.
For reference, in the United States, 12 ounces of regular beer, 5 ounces of wine, or a 1.5-ounce shot of distilled spirits contains about 14 grams of alcohol.
Diastolic BP (DBP) was 1.14 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 3.10 mm Hg in those who consumed an average of 48 grams of alcohol per day.
Subgroup analyses by gender showed an almost linear association between baseline alcohol intake and SBP changes in men and women and for DBP in men, while in women, there was an inverted U-shaped association.
No safe level
“From a BP perspective, it’s best to avoid alcohol intake. This is what the WHO [World Health Organization] recommends,” Dr. Whelton said.
“If someone is already drinking alcohol and does not want to stop doing so, minimizing alcohol consumption is desirable; many guidelines recommend not starting to drink alcohol but in those already drinking alcohol, consumption of two or less standard drinks per day for men and one or less standard drinks of alcohol per day for women,” Dr. Whelton noted.
Commenting on the study for this article, Alberto Ascherio, MD, of Harvard T. H. Chan School of Public Health, Boston, said it’s been known for more than 30 years that alcohol intake is associated with increased systolic and diastolic BP. The added value of this new study is a “refinement of the estimate of the dose response.”
Dr. Ascherio noted that “moderate alcohol consumption is associated with a modest increase in risk of cancer, but, in spite of the adverse association with BP, with a potentially beneficial effect on cardiovascular disease.” However, “the causality of the latter association has been questioned, but there is no consensus on this.”
Also weighing in, Timothy Brennan, MD, MPH, chief of clinical services for the Addiction Institute of Mount Sinai Health System in New York City, said this new study represents “yet another piece of evidence suggesting that there simply is no ‘healthy’ amount of alcohol use in humans.
“Even small amounts of alcohol intake can have negative health effects, as demonstrated in this study,” Dr. Brennan said. “There is still a widely held belief among people that drinking in moderation is good for you. It is becoming more and more clear that this is simply not the case. As health authorities grapple with drinking ‘recommendations,’ additional datasets like these will be helpful.”
The study had no specific funding. Dr. Whelton, Dr. Vinceti, Dr. Ascherio, and Dr. Brennan have no relevant disclosures.
A version of this article first appeared on Medscape.com.
“A vexing question has been whether usual intake of small amounts of alcohol is associated with a higher level of BP. We identified a continuous, more or less linear association, with no evidence of a threshold for the association,” study coauthor Paul Whelton, MD, of Tulane University School of Public Health and Tropical Medicine, New Orleans, said in an interview.
For systolic BP (SBP), “the most important BP risk indicator for CVD [cardiovascular disease], the association was robust, being present in both men and women and in both North America as well as Asia,” Dr. Whelton noted.
Based on the results, “the lower the better, and no consumption even better, as we did not find any indication that human health may benefit from consumption of very small amounts of alcohol,” senior author Marco Vinceti, MD, PhD, of University of Modena and Reggio Emilia University in Italy, told this news organization.
“Clearly, alcohol is not the only or necessarily the main determinant of high blood pressure, and the effects of small intakes of alcohol emerging from our pooled analysis were certainly not biologically as relevant and meaningful as those induced by high intakes,” Dr. Vinceti added.
The study was published online in Hypertension.
The researchers analyzed data from seven large, observational studies conducted in the United States, Korea, and Japan involving 19,548 adults (65% men).
Participants ranged in age from 20 years to the early 70s at baseline and were followed for a median of 5.3 years (range, 4-12 years). None of the participants had previously been diagnosed with hypertension or other CVD, diabetes, liver disease, alcoholism, or binge drinking.
Compared with nondrinkers, SBP was 1.25 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 4.90 mm Hg in adults consuming an average of 48 grams of alcohol per day.
For reference, in the United States, 12 ounces of regular beer, 5 ounces of wine, or a 1.5-ounce shot of distilled spirits contains about 14 grams of alcohol.
Diastolic BP (DBP) was 1.14 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 3.10 mm Hg in those who consumed an average of 48 grams of alcohol per day.
Subgroup analyses by gender showed an almost linear association between baseline alcohol intake and SBP changes in men and women and for DBP in men, while in women, there was an inverted U-shaped association.
No safe level
“From a BP perspective, it’s best to avoid alcohol intake. This is what the WHO [World Health Organization] recommends,” Dr. Whelton said.
“If someone is already drinking alcohol and does not want to stop doing so, minimizing alcohol consumption is desirable; many guidelines recommend not starting to drink alcohol but in those already drinking alcohol, consumption of two or less standard drinks per day for men and one or less standard drinks of alcohol per day for women,” Dr. Whelton noted.
Commenting on the study for this article, Alberto Ascherio, MD, of Harvard T. H. Chan School of Public Health, Boston, said it’s been known for more than 30 years that alcohol intake is associated with increased systolic and diastolic BP. The added value of this new study is a “refinement of the estimate of the dose response.”
Dr. Ascherio noted that “moderate alcohol consumption is associated with a modest increase in risk of cancer, but, in spite of the adverse association with BP, with a potentially beneficial effect on cardiovascular disease.” However, “the causality of the latter association has been questioned, but there is no consensus on this.”
Also weighing in, Timothy Brennan, MD, MPH, chief of clinical services for the Addiction Institute of Mount Sinai Health System in New York City, said this new study represents “yet another piece of evidence suggesting that there simply is no ‘healthy’ amount of alcohol use in humans.
“Even small amounts of alcohol intake can have negative health effects, as demonstrated in this study,” Dr. Brennan said. “There is still a widely held belief among people that drinking in moderation is good for you. It is becoming more and more clear that this is simply not the case. As health authorities grapple with drinking ‘recommendations,’ additional datasets like these will be helpful.”
The study had no specific funding. Dr. Whelton, Dr. Vinceti, Dr. Ascherio, and Dr. Brennan have no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM HYPERTENSION
Heat waves plus air pollution tied to doubling of fatal MI
, a study from China suggests.
The researchers estimate that up to 3% of all deaths due to MI could be attributed to the combination of extreme temperatures and high levels of ambient fine particulate matter (PM2.5).
“Our findings provide evidence that reducing exposure to both extreme temperatures and fine particulate pollution may be useful to prevent premature deaths from heart attack,” senior author Yuewei Liu, MD, PhD, with Sun Yat-sen University in Guangzhou, China, said in a statement.
There is “long-standing evidence” of the harmful cardiovascular effects of air pollution, Jonathan Newman, MD, MPH, cardiologist at NYU Langone Heart in New York, who wasn’t involved in the study, said in an interview.
The added value of this study was finding an interaction between extreme hot temperatures and air pollution, “which is worrisome with global warming,” said Dr. Newman, assistant professor, department of medicine, the Leon H. Charney Division of Cardiology at NYU Langone Health.
The study was published online in Circulation.
Intensity and duration matter
The researchers analyzed data on 202,678 adults (mean age, 77.6 years; 52% male) who suffered fatal MI between 2015 and 2020 in Jiangsu province, a region with four distinct seasons and a wide range of temperatures and ambient PM2.5.
They evaluated the association of exposure to extreme temperature events, including both hot and cold spells, and PM2.5 with MI mortality, and their interactive effects.
Among the key findings:
- The risk of fatal MI was 18% higher during 2-day heat waves with heat indexes at or above the 90th percentile (ranging from 82.6° to 97.9° F) and 74% higher during 4-day heat waves with heat indexes at or above the 97.5th percentile (ranging from 94.8° to 109.4° F), compared with control days.
- The risk of fatal MI was 4% higher during 2-day cold snaps with temperatures at or below the 10th percentile (ranging from 33.3° to 40.5° F) and 12% higher during 3-day cold snaps with temperatures at or below the 2.5th percentile (ranging from 27.0° to 37.2° F).
- The risk of fatal MI was twice as high during 4-day heat waves that had PM2.5 above 37.5 mcg/m3. Days with high levels of PM2.5 during cold snaps did not have an equivalent increase in the risk of fatal MI.
- Up to 2.8% of MI deaths during the 5-year study period may be attributable to the combination of extreme temperature exposure and PM2.5 at levels exceeding World Health Organization air quality guidelines (37.5 mcg/m3).
- The risk of fatal MI was generally higher among women than men during heat waves and was higher among adults 80 years old and older than in younger adults during heat waves, cold snaps, or days with high levels of PM2.5.
The finding that adults over age 80 are particularly susceptible to the effects of heat and air pollution and the interaction of the two is “notable and particularly relevant given the aging of the population,” Dr. Newman told this news organization.
Mitigating both extreme temperature events and PM2.5 exposures “may bring health cobenefits in preventing premature deaths from MI,” the researchers write.
“To improve public health, it is important to take fine particulate pollution into consideration when providing extreme temperature warnings to the public,” Dr. Liu adds in the statement.
In an earlier study, Dr. Liu and colleagues showed that exposure to both large and small particulate matter, as well as nitrogen dioxide, was significantly associated with increased odds of death from MI.
This study was funded by China’s Ministry of Science and Technology. The authors and Dr. Newman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, a study from China suggests.
The researchers estimate that up to 3% of all deaths due to MI could be attributed to the combination of extreme temperatures and high levels of ambient fine particulate matter (PM2.5).
“Our findings provide evidence that reducing exposure to both extreme temperatures and fine particulate pollution may be useful to prevent premature deaths from heart attack,” senior author Yuewei Liu, MD, PhD, with Sun Yat-sen University in Guangzhou, China, said in a statement.
There is “long-standing evidence” of the harmful cardiovascular effects of air pollution, Jonathan Newman, MD, MPH, cardiologist at NYU Langone Heart in New York, who wasn’t involved in the study, said in an interview.
The added value of this study was finding an interaction between extreme hot temperatures and air pollution, “which is worrisome with global warming,” said Dr. Newman, assistant professor, department of medicine, the Leon H. Charney Division of Cardiology at NYU Langone Health.
The study was published online in Circulation.
Intensity and duration matter
The researchers analyzed data on 202,678 adults (mean age, 77.6 years; 52% male) who suffered fatal MI between 2015 and 2020 in Jiangsu province, a region with four distinct seasons and a wide range of temperatures and ambient PM2.5.
They evaluated the association of exposure to extreme temperature events, including both hot and cold spells, and PM2.5 with MI mortality, and their interactive effects.
Among the key findings:
- The risk of fatal MI was 18% higher during 2-day heat waves with heat indexes at or above the 90th percentile (ranging from 82.6° to 97.9° F) and 74% higher during 4-day heat waves with heat indexes at or above the 97.5th percentile (ranging from 94.8° to 109.4° F), compared with control days.
- The risk of fatal MI was 4% higher during 2-day cold snaps with temperatures at or below the 10th percentile (ranging from 33.3° to 40.5° F) and 12% higher during 3-day cold snaps with temperatures at or below the 2.5th percentile (ranging from 27.0° to 37.2° F).
- The risk of fatal MI was twice as high during 4-day heat waves that had PM2.5 above 37.5 mcg/m3. Days with high levels of PM2.5 during cold snaps did not have an equivalent increase in the risk of fatal MI.
- Up to 2.8% of MI deaths during the 5-year study period may be attributable to the combination of extreme temperature exposure and PM2.5 at levels exceeding World Health Organization air quality guidelines (37.5 mcg/m3).
- The risk of fatal MI was generally higher among women than men during heat waves and was higher among adults 80 years old and older than in younger adults during heat waves, cold snaps, or days with high levels of PM2.5.
The finding that adults over age 80 are particularly susceptible to the effects of heat and air pollution and the interaction of the two is “notable and particularly relevant given the aging of the population,” Dr. Newman told this news organization.
Mitigating both extreme temperature events and PM2.5 exposures “may bring health cobenefits in preventing premature deaths from MI,” the researchers write.
“To improve public health, it is important to take fine particulate pollution into consideration when providing extreme temperature warnings to the public,” Dr. Liu adds in the statement.
In an earlier study, Dr. Liu and colleagues showed that exposure to both large and small particulate matter, as well as nitrogen dioxide, was significantly associated with increased odds of death from MI.
This study was funded by China’s Ministry of Science and Technology. The authors and Dr. Newman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, a study from China suggests.
The researchers estimate that up to 3% of all deaths due to MI could be attributed to the combination of extreme temperatures and high levels of ambient fine particulate matter (PM2.5).
“Our findings provide evidence that reducing exposure to both extreme temperatures and fine particulate pollution may be useful to prevent premature deaths from heart attack,” senior author Yuewei Liu, MD, PhD, with Sun Yat-sen University in Guangzhou, China, said in a statement.
There is “long-standing evidence” of the harmful cardiovascular effects of air pollution, Jonathan Newman, MD, MPH, cardiologist at NYU Langone Heart in New York, who wasn’t involved in the study, said in an interview.
The added value of this study was finding an interaction between extreme hot temperatures and air pollution, “which is worrisome with global warming,” said Dr. Newman, assistant professor, department of medicine, the Leon H. Charney Division of Cardiology at NYU Langone Health.
The study was published online in Circulation.
Intensity and duration matter
The researchers analyzed data on 202,678 adults (mean age, 77.6 years; 52% male) who suffered fatal MI between 2015 and 2020 in Jiangsu province, a region with four distinct seasons and a wide range of temperatures and ambient PM2.5.
They evaluated the association of exposure to extreme temperature events, including both hot and cold spells, and PM2.5 with MI mortality, and their interactive effects.
Among the key findings:
- The risk of fatal MI was 18% higher during 2-day heat waves with heat indexes at or above the 90th percentile (ranging from 82.6° to 97.9° F) and 74% higher during 4-day heat waves with heat indexes at or above the 97.5th percentile (ranging from 94.8° to 109.4° F), compared with control days.
- The risk of fatal MI was 4% higher during 2-day cold snaps with temperatures at or below the 10th percentile (ranging from 33.3° to 40.5° F) and 12% higher during 3-day cold snaps with temperatures at or below the 2.5th percentile (ranging from 27.0° to 37.2° F).
- The risk of fatal MI was twice as high during 4-day heat waves that had PM2.5 above 37.5 mcg/m3. Days with high levels of PM2.5 during cold snaps did not have an equivalent increase in the risk of fatal MI.
- Up to 2.8% of MI deaths during the 5-year study period may be attributable to the combination of extreme temperature exposure and PM2.5 at levels exceeding World Health Organization air quality guidelines (37.5 mcg/m3).
- The risk of fatal MI was generally higher among women than men during heat waves and was higher among adults 80 years old and older than in younger adults during heat waves, cold snaps, or days with high levels of PM2.5.
The finding that adults over age 80 are particularly susceptible to the effects of heat and air pollution and the interaction of the two is “notable and particularly relevant given the aging of the population,” Dr. Newman told this news organization.
Mitigating both extreme temperature events and PM2.5 exposures “may bring health cobenefits in preventing premature deaths from MI,” the researchers write.
“To improve public health, it is important to take fine particulate pollution into consideration when providing extreme temperature warnings to the public,” Dr. Liu adds in the statement.
In an earlier study, Dr. Liu and colleagues showed that exposure to both large and small particulate matter, as well as nitrogen dioxide, was significantly associated with increased odds of death from MI.
This study was funded by China’s Ministry of Science and Technology. The authors and Dr. Newman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CIRCULATION
Daily aspirin for stroke prevention in healthy elderly should be avoided
according to results from a large randomized trial.
The findings, published in JAMA Network Open, bolster recommendations published in 2022 by the U.S. Preventive Services Task Force against daily aspirin for primary prevention of stroke in older adults and add to a mounting consensus that it should be avoided in the healthy elderly, for whom bleeding risks outweigh potential benefits.
Stroke was a preplanned secondary outcome of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which randomized 19,114 community-living people in Australia and the United States (56% women, 91% White) to 100 mg. daily aspirin or placebo. Participants were aged 70 and older, with the exception of U.S. Black and Hispanic individuals, who could be as young as 65. Participants did not have disability or known cardiovascular disease at baseline, and blood pressure was adequately controlled.
ASPEE findings
In 2018 the ASPREE authors, led by John McNeil, PhD, of Monash University, Melbourne, published their findings that aspirin did not reduce mortality or cardiovascular events (including stroke) in the same large cohort.
The new analysis, led by Geoffrey Cloud, MB, BS, of Monash University, focuses on stroke and intracranial bleeding outcomes. At 5 years’ follow up, the ASPREE investigators saw no significant reduction in ischemic stroke incidence associated with aspirin (hazard ratio, 0.89; 95% confidence interval, 0.71-1.11), while incidence of all types of intracranial bleeding, including hemorrhagic stroke, was significantly increased (HR, 1.38; 95% CI, 1.03-1.84).
Altogether 108 of participants taking aspirin (1.1%) experienced some form of intracranial bleeding (subdural, extradural, and/or subarachnoid), compared with 79 (0.8%) in the placebo group. Aspirin-treated patients also saw more hemorrhagic stroke (0.5% vs. 0.4%). As the ASPREE investigators had reported in an earlier paper, upper gastrointestinal bleeding occurred in significantly more aspirin-treated patients than those on placebo (HR, 1.87; 95% CI, 1.32-2.66).
“These outcomes may alter the balance of risks and benefits of an antiplatelet drug, especially if given to individuals at low risk in a primary prevention setting. This concern is relevant given the high stroke risk in older individuals, worldwide increases in populations of older individuals, and the importance of evaluating preventive strategies in this age group,” the investigators wrote.
The investigators cited the study’s large size as a strength while noting among its weaknesses that fewer stroke and bleeding events occurred during follow-up than expected, and that not all ischemic stroke events among older participants were thoroughly investigated.
Patients need to know their risk
In an interview, Shlee Song, MD, director of the stroke center at Cedars-Sinai, Los Angeles, said that the new ASPREE findings underscore the importance of careful communication with patients and their families, who may be confused about which risk group they belong to and either cease taking aspirin when it is in fact indicated, or take it when it could harm them.
“We need to be clear for our patients whether these results are relevant to them or not,” Dr. Song said. “People with a history of ischemic stroke need to know aspirin therapy is helpful in reducing risk of another stroke.”
Some patients may come to believe that because their stroke occurred a long time ago, they are in a lower-risk group. “But people need to understand that with a history of a heart attack or stroke, you’re always a separate group,” Dr. Song said. “Our job is also surveillance screening – have you had a fall this past year? Have you had a change in bowel movements? The bleeding events seen in ASPREE include bleeding in the head and bleeding in the gut.”
A key issue to stress with patients, Dr. Song said, is blood pressure management. “Patients might take aspirin because a family member had a stroke, without controlling blood pressure first. That could be the perfect storm for a head bleed: uncontrolled hypertension and an antiplatelet agent.”
The ASPREE study was funded by the National Institutes of Health in the United States and Monash University and the Victorian Cancer Agency in Australia. Three coauthors reported receiving funding or fees from drug manufacturers. Dr. Song disclosed no financial conflicts related to her comments.
according to results from a large randomized trial.
The findings, published in JAMA Network Open, bolster recommendations published in 2022 by the U.S. Preventive Services Task Force against daily aspirin for primary prevention of stroke in older adults and add to a mounting consensus that it should be avoided in the healthy elderly, for whom bleeding risks outweigh potential benefits.
Stroke was a preplanned secondary outcome of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which randomized 19,114 community-living people in Australia and the United States (56% women, 91% White) to 100 mg. daily aspirin or placebo. Participants were aged 70 and older, with the exception of U.S. Black and Hispanic individuals, who could be as young as 65. Participants did not have disability or known cardiovascular disease at baseline, and blood pressure was adequately controlled.
ASPEE findings
In 2018 the ASPREE authors, led by John McNeil, PhD, of Monash University, Melbourne, published their findings that aspirin did not reduce mortality or cardiovascular events (including stroke) in the same large cohort.
The new analysis, led by Geoffrey Cloud, MB, BS, of Monash University, focuses on stroke and intracranial bleeding outcomes. At 5 years’ follow up, the ASPREE investigators saw no significant reduction in ischemic stroke incidence associated with aspirin (hazard ratio, 0.89; 95% confidence interval, 0.71-1.11), while incidence of all types of intracranial bleeding, including hemorrhagic stroke, was significantly increased (HR, 1.38; 95% CI, 1.03-1.84).
Altogether 108 of participants taking aspirin (1.1%) experienced some form of intracranial bleeding (subdural, extradural, and/or subarachnoid), compared with 79 (0.8%) in the placebo group. Aspirin-treated patients also saw more hemorrhagic stroke (0.5% vs. 0.4%). As the ASPREE investigators had reported in an earlier paper, upper gastrointestinal bleeding occurred in significantly more aspirin-treated patients than those on placebo (HR, 1.87; 95% CI, 1.32-2.66).
“These outcomes may alter the balance of risks and benefits of an antiplatelet drug, especially if given to individuals at low risk in a primary prevention setting. This concern is relevant given the high stroke risk in older individuals, worldwide increases in populations of older individuals, and the importance of evaluating preventive strategies in this age group,” the investigators wrote.
The investigators cited the study’s large size as a strength while noting among its weaknesses that fewer stroke and bleeding events occurred during follow-up than expected, and that not all ischemic stroke events among older participants were thoroughly investigated.
Patients need to know their risk
In an interview, Shlee Song, MD, director of the stroke center at Cedars-Sinai, Los Angeles, said that the new ASPREE findings underscore the importance of careful communication with patients and their families, who may be confused about which risk group they belong to and either cease taking aspirin when it is in fact indicated, or take it when it could harm them.
“We need to be clear for our patients whether these results are relevant to them or not,” Dr. Song said. “People with a history of ischemic stroke need to know aspirin therapy is helpful in reducing risk of another stroke.”
Some patients may come to believe that because their stroke occurred a long time ago, they are in a lower-risk group. “But people need to understand that with a history of a heart attack or stroke, you’re always a separate group,” Dr. Song said. “Our job is also surveillance screening – have you had a fall this past year? Have you had a change in bowel movements? The bleeding events seen in ASPREE include bleeding in the head and bleeding in the gut.”
A key issue to stress with patients, Dr. Song said, is blood pressure management. “Patients might take aspirin because a family member had a stroke, without controlling blood pressure first. That could be the perfect storm for a head bleed: uncontrolled hypertension and an antiplatelet agent.”
The ASPREE study was funded by the National Institutes of Health in the United States and Monash University and the Victorian Cancer Agency in Australia. Three coauthors reported receiving funding or fees from drug manufacturers. Dr. Song disclosed no financial conflicts related to her comments.
according to results from a large randomized trial.
The findings, published in JAMA Network Open, bolster recommendations published in 2022 by the U.S. Preventive Services Task Force against daily aspirin for primary prevention of stroke in older adults and add to a mounting consensus that it should be avoided in the healthy elderly, for whom bleeding risks outweigh potential benefits.
Stroke was a preplanned secondary outcome of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which randomized 19,114 community-living people in Australia and the United States (56% women, 91% White) to 100 mg. daily aspirin or placebo. Participants were aged 70 and older, with the exception of U.S. Black and Hispanic individuals, who could be as young as 65. Participants did not have disability or known cardiovascular disease at baseline, and blood pressure was adequately controlled.
ASPEE findings
In 2018 the ASPREE authors, led by John McNeil, PhD, of Monash University, Melbourne, published their findings that aspirin did not reduce mortality or cardiovascular events (including stroke) in the same large cohort.
The new analysis, led by Geoffrey Cloud, MB, BS, of Monash University, focuses on stroke and intracranial bleeding outcomes. At 5 years’ follow up, the ASPREE investigators saw no significant reduction in ischemic stroke incidence associated with aspirin (hazard ratio, 0.89; 95% confidence interval, 0.71-1.11), while incidence of all types of intracranial bleeding, including hemorrhagic stroke, was significantly increased (HR, 1.38; 95% CI, 1.03-1.84).
Altogether 108 of participants taking aspirin (1.1%) experienced some form of intracranial bleeding (subdural, extradural, and/or subarachnoid), compared with 79 (0.8%) in the placebo group. Aspirin-treated patients also saw more hemorrhagic stroke (0.5% vs. 0.4%). As the ASPREE investigators had reported in an earlier paper, upper gastrointestinal bleeding occurred in significantly more aspirin-treated patients than those on placebo (HR, 1.87; 95% CI, 1.32-2.66).
“These outcomes may alter the balance of risks and benefits of an antiplatelet drug, especially if given to individuals at low risk in a primary prevention setting. This concern is relevant given the high stroke risk in older individuals, worldwide increases in populations of older individuals, and the importance of evaluating preventive strategies in this age group,” the investigators wrote.
The investigators cited the study’s large size as a strength while noting among its weaknesses that fewer stroke and bleeding events occurred during follow-up than expected, and that not all ischemic stroke events among older participants were thoroughly investigated.
Patients need to know their risk
In an interview, Shlee Song, MD, director of the stroke center at Cedars-Sinai, Los Angeles, said that the new ASPREE findings underscore the importance of careful communication with patients and their families, who may be confused about which risk group they belong to and either cease taking aspirin when it is in fact indicated, or take it when it could harm them.
“We need to be clear for our patients whether these results are relevant to them or not,” Dr. Song said. “People with a history of ischemic stroke need to know aspirin therapy is helpful in reducing risk of another stroke.”
Some patients may come to believe that because their stroke occurred a long time ago, they are in a lower-risk group. “But people need to understand that with a history of a heart attack or stroke, you’re always a separate group,” Dr. Song said. “Our job is also surveillance screening – have you had a fall this past year? Have you had a change in bowel movements? The bleeding events seen in ASPREE include bleeding in the head and bleeding in the gut.”
A key issue to stress with patients, Dr. Song said, is blood pressure management. “Patients might take aspirin because a family member had a stroke, without controlling blood pressure first. That could be the perfect storm for a head bleed: uncontrolled hypertension and an antiplatelet agent.”
The ASPREE study was funded by the National Institutes of Health in the United States and Monash University and the Victorian Cancer Agency in Australia. Three coauthors reported receiving funding or fees from drug manufacturers. Dr. Song disclosed no financial conflicts related to her comments.
FROM JAMA NETWORK OPEN
Class I recall of GE Healthcare TruSignal SpO2 sensors
The Food and Drug Administration has identified this as a class I recall, the most serious type. The company has not received any reports of patient injury or deaths as a result of these issues.*
The recall includes the TruSignal Adult Pediatric Sensor, TruSignal AllFit Sensor, TruSignal Sensitive Skin Sensor, TruSignal Wrap Sensor, TruSignal Ear Sensor, TruSignal Integrated Ear Sensor with GE Connector, TruSignal Integrated Ear Sensor With Datex Connector, TruSignal Integrated Ear Sensor With Datex Connector, and TruSignal Integrated Ear Sensor With Ohmeda Connector.
The sensors were distributed in the United States from Jan. 1, 2021, to March 4, 2023.
According to the recall notice, the malfunctioning sensors “may reduce the amount of energy sent to the heart during defibrillation without any notification to the care provider, which could prevent delivery of lifesaving therapy in a critical situation.
“This issue is most hazardous to hospitalized patients who may need defibrillation for cardiac arrest. Affected sensors may also unintentionally expose patients to electrical currents from other sources or may provide inaccurate measurements of SpO2, which can impact treatment decisions,” the notice warns.
In an urgent device correction letter sent to health care professionals in May, GE HealthCare recommends that health care professionals do the following:
- Use an alternate method for SpO2 monitoring, including TruSignal sensors not impacted or an alternate SpO2 device.
- If alternate methods are not available, use affected TruSignal SpO2 sensors as long as they have not been saturated with fluids.
- If defibrillation is necessary when affected TruSignal SpO2 sensors are being used, remove the affected TruSignal SpO2 sensor, defibrillate per hospital protocol, and reattach the affected TruSignal SpO2 sensor after defibrillation is no longer needed.
- For Adult/Pediatric SpO2 sensors, confirm that material does not cover the emitter or detector before using.
- Discard the sensor and use another sensor if any additional material is present.
- Make sure all potential users are made aware of this safety notification and the recommended actions, and retain this notice.
Customers are also asked to complete and return the acknowledgment form attached to the notice to [email protected].
For questions or concerns about this recall, contact GE HealthCare Service at 1-800-437-1171 or a local service representative.
Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
*Correction, 8/3/23: An earlier version of this article mischaracterized the reports received by the company.
The Food and Drug Administration has identified this as a class I recall, the most serious type. The company has not received any reports of patient injury or deaths as a result of these issues.*
The recall includes the TruSignal Adult Pediatric Sensor, TruSignal AllFit Sensor, TruSignal Sensitive Skin Sensor, TruSignal Wrap Sensor, TruSignal Ear Sensor, TruSignal Integrated Ear Sensor with GE Connector, TruSignal Integrated Ear Sensor With Datex Connector, TruSignal Integrated Ear Sensor With Datex Connector, and TruSignal Integrated Ear Sensor With Ohmeda Connector.
The sensors were distributed in the United States from Jan. 1, 2021, to March 4, 2023.
According to the recall notice, the malfunctioning sensors “may reduce the amount of energy sent to the heart during defibrillation without any notification to the care provider, which could prevent delivery of lifesaving therapy in a critical situation.
“This issue is most hazardous to hospitalized patients who may need defibrillation for cardiac arrest. Affected sensors may also unintentionally expose patients to electrical currents from other sources or may provide inaccurate measurements of SpO2, which can impact treatment decisions,” the notice warns.
In an urgent device correction letter sent to health care professionals in May, GE HealthCare recommends that health care professionals do the following:
- Use an alternate method for SpO2 monitoring, including TruSignal sensors not impacted or an alternate SpO2 device.
- If alternate methods are not available, use affected TruSignal SpO2 sensors as long as they have not been saturated with fluids.
- If defibrillation is necessary when affected TruSignal SpO2 sensors are being used, remove the affected TruSignal SpO2 sensor, defibrillate per hospital protocol, and reattach the affected TruSignal SpO2 sensor after defibrillation is no longer needed.
- For Adult/Pediatric SpO2 sensors, confirm that material does not cover the emitter or detector before using.
- Discard the sensor and use another sensor if any additional material is present.
- Make sure all potential users are made aware of this safety notification and the recommended actions, and retain this notice.
Customers are also asked to complete and return the acknowledgment form attached to the notice to [email protected].
For questions or concerns about this recall, contact GE HealthCare Service at 1-800-437-1171 or a local service representative.
Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
*Correction, 8/3/23: An earlier version of this article mischaracterized the reports received by the company.
The Food and Drug Administration has identified this as a class I recall, the most serious type. The company has not received any reports of patient injury or deaths as a result of these issues.*
The recall includes the TruSignal Adult Pediatric Sensor, TruSignal AllFit Sensor, TruSignal Sensitive Skin Sensor, TruSignal Wrap Sensor, TruSignal Ear Sensor, TruSignal Integrated Ear Sensor with GE Connector, TruSignal Integrated Ear Sensor With Datex Connector, TruSignal Integrated Ear Sensor With Datex Connector, and TruSignal Integrated Ear Sensor With Ohmeda Connector.
The sensors were distributed in the United States from Jan. 1, 2021, to March 4, 2023.
According to the recall notice, the malfunctioning sensors “may reduce the amount of energy sent to the heart during defibrillation without any notification to the care provider, which could prevent delivery of lifesaving therapy in a critical situation.
“This issue is most hazardous to hospitalized patients who may need defibrillation for cardiac arrest. Affected sensors may also unintentionally expose patients to electrical currents from other sources or may provide inaccurate measurements of SpO2, which can impact treatment decisions,” the notice warns.
In an urgent device correction letter sent to health care professionals in May, GE HealthCare recommends that health care professionals do the following:
- Use an alternate method for SpO2 monitoring, including TruSignal sensors not impacted or an alternate SpO2 device.
- If alternate methods are not available, use affected TruSignal SpO2 sensors as long as they have not been saturated with fluids.
- If defibrillation is necessary when affected TruSignal SpO2 sensors are being used, remove the affected TruSignal SpO2 sensor, defibrillate per hospital protocol, and reattach the affected TruSignal SpO2 sensor after defibrillation is no longer needed.
- For Adult/Pediatric SpO2 sensors, confirm that material does not cover the emitter or detector before using.
- Discard the sensor and use another sensor if any additional material is present.
- Make sure all potential users are made aware of this safety notification and the recommended actions, and retain this notice.
Customers are also asked to complete and return the acknowledgment form attached to the notice to [email protected].
For questions or concerns about this recall, contact GE HealthCare Service at 1-800-437-1171 or a local service representative.
Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
*Correction, 8/3/23: An earlier version of this article mischaracterized the reports received by the company.
Higher step counts tied to fewer symptoms in HF
Daily step counts between 1,000 and 5,000 were significantly associated with symptoms and physical limitations, as reflected in Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom (TS) and physical limitation (PL) scores.
Participants whose step counts increased by 2,000 steps per day demonstrated a 5.2-point increase in their KCCQ-TS scores and a 5.33-point increase in their KCCQ-PL scores, with higher scores reflecting improvement.
However, declines in step counts were not associated with significant declines in KCCQ-PL scores.
The findings are not yet ready to be implemented into practice, first author Jessica R. Golbus, MD, of the University of Michigan, Ann Arbor, said in an interview. However, she said, they “suggest that clinicians should interpret improvements in step counts as indicative of improving health status, though they should not necessarily be as concerned with reductions in step count.
“I would certainly, however, still encourage clinicians to discuss decrementing physical activity levels with their patients, though an intervention may not necessarily be warranted,” she added.
The study was published online in JACC: Heart Failure.
Nonlinear relationship
The investigators analyzed data from the Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF) trial, a randomized, controlled trial that enrolled participants with heart failure who had a smartphone.
Participants were given a Fitbit Versa 2 and completed serial KCCQs via the smartphone app.
The researchers assessed the relationship between daily step count and KCCQ-TS and KCCQ-PL scores at baseline, as well as changes in the scores between 2 and 12 weeks.
The study included 425 patients. The mean age was 63.5 years, 44.5% were women, and 83.3% were White; 40.9% had reduced ejection fraction, 59.1% had preserved ejection fraction, and 27.5% had type 2 diabetes.
At 2 weeks, the mean KCCQ-TS score was 62.7, and the mean KCCQ-PL score was 55.7.
KCCQ-TS scores increased by 2.5 points on average, and KCCQ-PL scores by 4 points through 12 weeks.
When categorized by 25-point ranges, the step count increased with increasing scores for both KCCQ-TS and KCCQ-PL. Those with KCCQ-TS scores of 0-24 averaged 2,437.6 steps daily, and those with scores of 75-100 averaged 4,870.9 steps daily.
Similarly, participants with KCCQ-PL scores of 0-24 averaged 2301.5 steps daily, and those with scores of 75-100 averaged 5,351.9. The relationship remained significant after adjustment.
There were nonlinear relationships between activity and KCCQ scores: Daily step counts below 5,000 steps were associated with KCCQ scores, but there was little association with counts above 5,000 steps.
Compared with participants who walked 2,000 steps per day, those who walked 1,000 had KCCQ-TS scores that were 3.11 points lower; participants who walked 3,000 had KCCQ-TS scores that were 2.89 points higher.
Similarly, participants who walked 1,000 steps per day had KCCQ-PL scores that were 5.36 points lower than those who walked 2,000 steps, and those who walked 3,000 steps had KCCQ-PL scores that were 4.97 points higher.
After adjustment, change in daily step counts was significantly associated with a change in KCCQ-PL scores from baseline through 12 weeks; for example, participants whose step counts increased by 2,000 steps per day experienced a 5.33 increase in their KCCQ-PL scores relative to participants whose step counts did not change.
‘New kid on the block’
Frederick Ho, PhD, a lecturer in public health at the University of Glasgow (Scotland), who is a volunteer spokesperson for the American Heart Association, called the study “promising.”
“The study follow-up is relatively short, so it is not known whether the association is valid longer term,” he said in an interview. “It is also possible that patients with more severe symptoms became physically less active, and at the same time had worse outcomes.
“A study with longer follow-up among patients from a broader background would provide confidence on the generalizability of the findings,” said Dr. Ho, who led a recent study that showed accelerometer-measured physical activity was associated with a lower risk of heart failure. “It’d also be interesting to validate the findings using different types of wearable devices.”
Previous studies have shown that wrist-worn wearables might overestimate light-intensity activities, compared with hip-worn devices, he noted. “I’d imagine that the findings would be slightly different due to different types of devices, but the overall premise should remain.”
In a related editorial, Mitchell Psotka, MD, PhD, writes that Dr. Golbus and colleagues “have thankfully moved our understanding of actigraphy forward, although it is still the new kid on the block and will require substantial further testing and validation before widespread reliable clinical and research use.”
Terminology and reporting features need to be standardized, and preferred methods of implementation need to be established, including how to wear the devices, he suggests.
Further research is needed to validate that “accelerometers and their digitally processed movement ‘counts’ actually measure activity and that this measured activity has clinical relevance.”
The study did not receive commercial funding. Dr. Golbus, Dr. Ho, and Dr. Psotka report no relevant relationships.
A version of this article first appeared on Medscape.com.
Daily step counts between 1,000 and 5,000 were significantly associated with symptoms and physical limitations, as reflected in Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom (TS) and physical limitation (PL) scores.
Participants whose step counts increased by 2,000 steps per day demonstrated a 5.2-point increase in their KCCQ-TS scores and a 5.33-point increase in their KCCQ-PL scores, with higher scores reflecting improvement.
However, declines in step counts were not associated with significant declines in KCCQ-PL scores.
The findings are not yet ready to be implemented into practice, first author Jessica R. Golbus, MD, of the University of Michigan, Ann Arbor, said in an interview. However, she said, they “suggest that clinicians should interpret improvements in step counts as indicative of improving health status, though they should not necessarily be as concerned with reductions in step count.
“I would certainly, however, still encourage clinicians to discuss decrementing physical activity levels with their patients, though an intervention may not necessarily be warranted,” she added.
The study was published online in JACC: Heart Failure.
Nonlinear relationship
The investigators analyzed data from the Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF) trial, a randomized, controlled trial that enrolled participants with heart failure who had a smartphone.
Participants were given a Fitbit Versa 2 and completed serial KCCQs via the smartphone app.
The researchers assessed the relationship between daily step count and KCCQ-TS and KCCQ-PL scores at baseline, as well as changes in the scores between 2 and 12 weeks.
The study included 425 patients. The mean age was 63.5 years, 44.5% were women, and 83.3% were White; 40.9% had reduced ejection fraction, 59.1% had preserved ejection fraction, and 27.5% had type 2 diabetes.
At 2 weeks, the mean KCCQ-TS score was 62.7, and the mean KCCQ-PL score was 55.7.
KCCQ-TS scores increased by 2.5 points on average, and KCCQ-PL scores by 4 points through 12 weeks.
When categorized by 25-point ranges, the step count increased with increasing scores for both KCCQ-TS and KCCQ-PL. Those with KCCQ-TS scores of 0-24 averaged 2,437.6 steps daily, and those with scores of 75-100 averaged 4,870.9 steps daily.
Similarly, participants with KCCQ-PL scores of 0-24 averaged 2301.5 steps daily, and those with scores of 75-100 averaged 5,351.9. The relationship remained significant after adjustment.
There were nonlinear relationships between activity and KCCQ scores: Daily step counts below 5,000 steps were associated with KCCQ scores, but there was little association with counts above 5,000 steps.
Compared with participants who walked 2,000 steps per day, those who walked 1,000 had KCCQ-TS scores that were 3.11 points lower; participants who walked 3,000 had KCCQ-TS scores that were 2.89 points higher.
Similarly, participants who walked 1,000 steps per day had KCCQ-PL scores that were 5.36 points lower than those who walked 2,000 steps, and those who walked 3,000 steps had KCCQ-PL scores that were 4.97 points higher.
After adjustment, change in daily step counts was significantly associated with a change in KCCQ-PL scores from baseline through 12 weeks; for example, participants whose step counts increased by 2,000 steps per day experienced a 5.33 increase in their KCCQ-PL scores relative to participants whose step counts did not change.
‘New kid on the block’
Frederick Ho, PhD, a lecturer in public health at the University of Glasgow (Scotland), who is a volunteer spokesperson for the American Heart Association, called the study “promising.”
“The study follow-up is relatively short, so it is not known whether the association is valid longer term,” he said in an interview. “It is also possible that patients with more severe symptoms became physically less active, and at the same time had worse outcomes.
“A study with longer follow-up among patients from a broader background would provide confidence on the generalizability of the findings,” said Dr. Ho, who led a recent study that showed accelerometer-measured physical activity was associated with a lower risk of heart failure. “It’d also be interesting to validate the findings using different types of wearable devices.”
Previous studies have shown that wrist-worn wearables might overestimate light-intensity activities, compared with hip-worn devices, he noted. “I’d imagine that the findings would be slightly different due to different types of devices, but the overall premise should remain.”
In a related editorial, Mitchell Psotka, MD, PhD, writes that Dr. Golbus and colleagues “have thankfully moved our understanding of actigraphy forward, although it is still the new kid on the block and will require substantial further testing and validation before widespread reliable clinical and research use.”
Terminology and reporting features need to be standardized, and preferred methods of implementation need to be established, including how to wear the devices, he suggests.
Further research is needed to validate that “accelerometers and their digitally processed movement ‘counts’ actually measure activity and that this measured activity has clinical relevance.”
The study did not receive commercial funding. Dr. Golbus, Dr. Ho, and Dr. Psotka report no relevant relationships.
A version of this article first appeared on Medscape.com.
Daily step counts between 1,000 and 5,000 were significantly associated with symptoms and physical limitations, as reflected in Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom (TS) and physical limitation (PL) scores.
Participants whose step counts increased by 2,000 steps per day demonstrated a 5.2-point increase in their KCCQ-TS scores and a 5.33-point increase in their KCCQ-PL scores, with higher scores reflecting improvement.
However, declines in step counts were not associated with significant declines in KCCQ-PL scores.
The findings are not yet ready to be implemented into practice, first author Jessica R. Golbus, MD, of the University of Michigan, Ann Arbor, said in an interview. However, she said, they “suggest that clinicians should interpret improvements in step counts as indicative of improving health status, though they should not necessarily be as concerned with reductions in step count.
“I would certainly, however, still encourage clinicians to discuss decrementing physical activity levels with their patients, though an intervention may not necessarily be warranted,” she added.
The study was published online in JACC: Heart Failure.
Nonlinear relationship
The investigators analyzed data from the Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF) trial, a randomized, controlled trial that enrolled participants with heart failure who had a smartphone.
Participants were given a Fitbit Versa 2 and completed serial KCCQs via the smartphone app.
The researchers assessed the relationship between daily step count and KCCQ-TS and KCCQ-PL scores at baseline, as well as changes in the scores between 2 and 12 weeks.
The study included 425 patients. The mean age was 63.5 years, 44.5% were women, and 83.3% were White; 40.9% had reduced ejection fraction, 59.1% had preserved ejection fraction, and 27.5% had type 2 diabetes.
At 2 weeks, the mean KCCQ-TS score was 62.7, and the mean KCCQ-PL score was 55.7.
KCCQ-TS scores increased by 2.5 points on average, and KCCQ-PL scores by 4 points through 12 weeks.
When categorized by 25-point ranges, the step count increased with increasing scores for both KCCQ-TS and KCCQ-PL. Those with KCCQ-TS scores of 0-24 averaged 2,437.6 steps daily, and those with scores of 75-100 averaged 4,870.9 steps daily.
Similarly, participants with KCCQ-PL scores of 0-24 averaged 2301.5 steps daily, and those with scores of 75-100 averaged 5,351.9. The relationship remained significant after adjustment.
There were nonlinear relationships between activity and KCCQ scores: Daily step counts below 5,000 steps were associated with KCCQ scores, but there was little association with counts above 5,000 steps.
Compared with participants who walked 2,000 steps per day, those who walked 1,000 had KCCQ-TS scores that were 3.11 points lower; participants who walked 3,000 had KCCQ-TS scores that were 2.89 points higher.
Similarly, participants who walked 1,000 steps per day had KCCQ-PL scores that were 5.36 points lower than those who walked 2,000 steps, and those who walked 3,000 steps had KCCQ-PL scores that were 4.97 points higher.
After adjustment, change in daily step counts was significantly associated with a change in KCCQ-PL scores from baseline through 12 weeks; for example, participants whose step counts increased by 2,000 steps per day experienced a 5.33 increase in their KCCQ-PL scores relative to participants whose step counts did not change.
‘New kid on the block’
Frederick Ho, PhD, a lecturer in public health at the University of Glasgow (Scotland), who is a volunteer spokesperson for the American Heart Association, called the study “promising.”
“The study follow-up is relatively short, so it is not known whether the association is valid longer term,” he said in an interview. “It is also possible that patients with more severe symptoms became physically less active, and at the same time had worse outcomes.
“A study with longer follow-up among patients from a broader background would provide confidence on the generalizability of the findings,” said Dr. Ho, who led a recent study that showed accelerometer-measured physical activity was associated with a lower risk of heart failure. “It’d also be interesting to validate the findings using different types of wearable devices.”
Previous studies have shown that wrist-worn wearables might overestimate light-intensity activities, compared with hip-worn devices, he noted. “I’d imagine that the findings would be slightly different due to different types of devices, but the overall premise should remain.”
In a related editorial, Mitchell Psotka, MD, PhD, writes that Dr. Golbus and colleagues “have thankfully moved our understanding of actigraphy forward, although it is still the new kid on the block and will require substantial further testing and validation before widespread reliable clinical and research use.”
Terminology and reporting features need to be standardized, and preferred methods of implementation need to be established, including how to wear the devices, he suggests.
Further research is needed to validate that “accelerometers and their digitally processed movement ‘counts’ actually measure activity and that this measured activity has clinical relevance.”
The study did not receive commercial funding. Dr. Golbus, Dr. Ho, and Dr. Psotka report no relevant relationships.
A version of this article first appeared on Medscape.com.
FROM JACC: HEART FAILURE