CAD & Atherosclerosis

A recent ISCHEMIA trial substudy is under scrutiny from surgeons for a data discrepancy, rekindling concerns about reliance on the landmark trial data in the latest coronary revascularization guidelines.

As previously reported, the main ISCHEMIA findings showed no significant benefit for an initial strategy of percutaneous coronary intervention (PCI) or coronary bypass graft surgery (CABG) over medical therapy in patients with stable moderate to severe ischemic heart disease.

The 2021 substudy by Reynolds et al. showed that coronary artery disease (CAD) severity, classified using the modified Duke Prognostic Index score, predicted 4-year mortality and myocardial infarction in the trial, whereas ischemia severity did not.

Cardiac surgeons Joseph F. Sabik III, MD, and Faisal Bakaeen, MD, however, spotted that only 40 patients are in the Duke category 6 group (three-vessel severe stenosis of at least 70% or two-vessel severe stenosis with a proximal left anterior descending lesion) in Supplemental tables 1 and 2, whereas 659 are in the main paper.

In addition, the Supplemental tables list the following:

• 659 patients in Duke group 5, not 894 as in the paper.
• 894 patients in Duke group 4, not 743 as in the paper.
• 743 patients in Duke group 3, not 179 as in the paper.

The surgeons penned a letter to Circulation early in April flagging the discrepancies, but say it was rejected April 15 because it was submitted outside the journal’s 6-week window for letters. They posted a public comment on the Remarq research platform, as advised by Circulation’s editorial office, and reached out directly to the authors and ISCHEMIA leadership.

“They just keep saying it’s a simple formatting error. Well, if it is a simple formatting error, then fix it,” Dr. Sabik, chair of surgery at University Hospitals Cleveland Medical Center, said in an interview. “But here we are now, a month later, and they still haven’t published our letter. Why? We’re the ones who identified the problem.”

Dr. Sabik said the accuracy of the data has important implications because the recent AHA/ACC/SCAI coronary revascularization guidelines used the ISCHEMIA data to downgrade the CABG recommendation for complex multivessel disease from class 1 to class 2B. Patients with a Duke 6 score are also typically the ones referred for CABG by today’s heart teams.

Several surgical societies have contested the guidelines, questioning whether the ISCHEMIA patients are truly reflective of those seen in clinical practice and questioning the decision to treat PCI and surgery as equivalent strategies to decrease ischemic events.

Dr. Bakaeen, from the Cleveland Clinic, told this news organization they don’t want a public battle over the data like the one that befell the EXCEL trial, and that it’s entirely possible the investigators might have inadvertently upgraded all the Duke score assignments by 1.

A systematic error, however, is more plausible than a formatting error, he said, because Supplemental tables 1 and 2 correspond exactly to the Duke 1 to Duke 7 sequence, suggesting the tables are correct and that the error might have occurred downstream, including in the manuscript.

The numbers should be consistent across all the ISCHEMIA manuscripts, Dr. Bakaeen added, but currently “don’t add up,” even after adjustment for different denominators, and especially for participants with left main disease.

They hope that publication of their letter, he said, will convince the authors to publicly share the data for patients in each of the seven modified Duke categories.

Lead author of the ISCHEMIA substudy, Harmony Reynolds, MD, New York (N.Y.) University Langone Health, told this news organization via email that as a result of a “formatting error in the transfer of data from the statistical output file to a Word document, data in Supplemental tables 1 and 2 were incorrect.”

She explained that they planned to present six, not seven, rows for the Duke score in the tables, collapsing the first two categories of nonobstructive disease (Duke 1-2), as they were in all other tables and figures. However, the Supplemental tables had incorrect row headings and because the Word program is designed to fill all available rows, it inserted the data from the output file into a seven-row table shell, duplicating the values for row 1 in the last row for left main disease of at least 50%.

“The data were correctly presented in the main manuscript tables and figures and in the remainder of the supplement, with a total of 659 patients in the subset with modified Duke prognostic index category 6 on coronary CT angiography,” Dr. Reynolds said.

She noted that Circulation will issue a correction. In addition, “we are in the process of preparing the data for public sharing soon. The data will include the Duke prognostic score at all levels.”

Circulation editor-in-chief Joseph A. Hill, MD, PhD, chief of cardiology at UT Southwestern Medical Center, Dallas, declined to be interviewed but confirmed via email that Dr. Bakaeen and Dr. Sabik’s letter and the correction will be published the week of May 16.

As for the delay, he said, “I received their reach-out just over 1 week ago, and per protocol, we conducted an internal evaluation of their allegations, which took a bit of time.”
 

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

A recent ISCHEMIA trial substudy is under scrutiny from surgeons for a data discrepancy, rekindling concerns about reliance on the landmark trial data in the latest coronary revascularization guidelines.

As previously reported, the main ISCHEMIA findings showed no significant benefit for an initial strategy of percutaneous coronary intervention (PCI) or coronary bypass graft surgery (CABG) over medical therapy in patients with stable moderate to severe ischemic heart disease.

The 2021 substudy by Reynolds et al. showed that coronary artery disease (CAD) severity, classified using the modified Duke Prognostic Index score, predicted 4-year mortality and myocardial infarction in the trial, whereas ischemia severity did not.

Cardiac surgeons Joseph F. Sabik III, MD, and Faisal Bakaeen, MD, however, spotted that only 40 patients are in the Duke category 6 group (three-vessel severe stenosis of at least 70% or two-vessel severe stenosis with a proximal left anterior descending lesion) in Supplemental tables 1 and 2, whereas 659 are in the main paper.

In addition, the Supplemental tables list the following:

• 659 patients in Duke group 5, not 894 as in the paper.
• 894 patients in Duke group 4, not 743 as in the paper.
• 743 patients in Duke group 3, not 179 as in the paper.

The surgeons penned a letter to Circulation early in April flagging the discrepancies, but say it was rejected April 15 because it was submitted outside the journal’s 6-week window for letters. They posted a public comment on the Remarq research platform, as advised by Circulation’s editorial office, and reached out directly to the authors and ISCHEMIA leadership.

“They just keep saying it’s a simple formatting error. Well, if it is a simple formatting error, then fix it,” Dr. Sabik, chair of surgery at University Hospitals Cleveland Medical Center, said in an interview. “But here we are now, a month later, and they still haven’t published our letter. Why? We’re the ones who identified the problem.”

Dr. Sabik said the accuracy of the data has important implications because the recent AHA/ACC/SCAI coronary revascularization guidelines used the ISCHEMIA data to downgrade the CABG recommendation for complex multivessel disease from class 1 to class 2B. Patients with a Duke 6 score are also typically the ones referred for CABG by today’s heart teams.

Several surgical societies have contested the guidelines, questioning whether the ISCHEMIA patients are truly reflective of those seen in clinical practice and questioning the decision to treat PCI and surgery as equivalent strategies to decrease ischemic events.

Dr. Bakaeen, from the Cleveland Clinic, told this news organization they don’t want a public battle over the data like the one that befell the EXCEL trial, and that it’s entirely possible the investigators might have inadvertently upgraded all the Duke score assignments by 1.

A systematic error, however, is more plausible than a formatting error, he said, because Supplemental tables 1 and 2 correspond exactly to the Duke 1 to Duke 7 sequence, suggesting the tables are correct and that the error might have occurred downstream, including in the manuscript.

The numbers should be consistent across all the ISCHEMIA manuscripts, Dr. Bakaeen added, but currently “don’t add up,” even after adjustment for different denominators, and especially for participants with left main disease.

They hope that publication of their letter, he said, will convince the authors to publicly share the data for patients in each of the seven modified Duke categories.

Lead author of the ISCHEMIA substudy, Harmony Reynolds, MD, New York (N.Y.) University Langone Health, told this news organization via email that as a result of a “formatting error in the transfer of data from the statistical output file to a Word document, data in Supplemental tables 1 and 2 were incorrect.”

She explained that they planned to present six, not seven, rows for the Duke score in the tables, collapsing the first two categories of nonobstructive disease (Duke 1-2), as they were in all other tables and figures. However, the Supplemental tables had incorrect row headings and because the Word program is designed to fill all available rows, it inserted the data from the output file into a seven-row table shell, duplicating the values for row 1 in the last row for left main disease of at least 50%.

“The data were correctly presented in the main manuscript tables and figures and in the remainder of the supplement, with a total of 659 patients in the subset with modified Duke prognostic index category 6 on coronary CT angiography,” Dr. Reynolds said.

She noted that Circulation will issue a correction. In addition, “we are in the process of preparing the data for public sharing soon. The data will include the Duke prognostic score at all levels.”

Circulation editor-in-chief Joseph A. Hill, MD, PhD, chief of cardiology at UT Southwestern Medical Center, Dallas, declined to be interviewed but confirmed via email that Dr. Bakaeen and Dr. Sabik’s letter and the correction will be published the week of May 16.

As for the delay, he said, “I received their reach-out just over 1 week ago, and per protocol, we conducted an internal evaluation of their allegations, which took a bit of time.”
 

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

A recent ISCHEMIA trial substudy is under scrutiny from surgeons for a data discrepancy, rekindling concerns about reliance on the landmark trial data in the latest coronary revascularization guidelines.

As previously reported, the main ISCHEMIA findings showed no significant benefit for an initial strategy of percutaneous coronary intervention (PCI) or coronary bypass graft surgery (CABG) over medical therapy in patients with stable moderate to severe ischemic heart disease.

The 2021 substudy by Reynolds et al. showed that coronary artery disease (CAD) severity, classified using the modified Duke Prognostic Index score, predicted 4-year mortality and myocardial infarction in the trial, whereas ischemia severity did not.

Cardiac surgeons Joseph F. Sabik III, MD, and Faisal Bakaeen, MD, however, spotted that only 40 patients are in the Duke category 6 group (three-vessel severe stenosis of at least 70% or two-vessel severe stenosis with a proximal left anterior descending lesion) in Supplemental tables 1 and 2, whereas 659 are in the main paper.

In addition, the Supplemental tables list the following:

• 659 patients in Duke group 5, not 894 as in the paper.
• 894 patients in Duke group 4, not 743 as in the paper.
• 743 patients in Duke group 3, not 179 as in the paper.

The surgeons penned a letter to Circulation early in April flagging the discrepancies, but say it was rejected April 15 because it was submitted outside the journal’s 6-week window for letters. They posted a public comment on the Remarq research platform, as advised by Circulation’s editorial office, and reached out directly to the authors and ISCHEMIA leadership.

“They just keep saying it’s a simple formatting error. Well, if it is a simple formatting error, then fix it,” Dr. Sabik, chair of surgery at University Hospitals Cleveland Medical Center, said in an interview. “But here we are now, a month later, and they still haven’t published our letter. Why? We’re the ones who identified the problem.”

Dr. Sabik said the accuracy of the data has important implications because the recent AHA/ACC/SCAI coronary revascularization guidelines used the ISCHEMIA data to downgrade the CABG recommendation for complex multivessel disease from class 1 to class 2B. Patients with a Duke 6 score are also typically the ones referred for CABG by today’s heart teams.

Several surgical societies have contested the guidelines, questioning whether the ISCHEMIA patients are truly reflective of those seen in clinical practice and questioning the decision to treat PCI and surgery as equivalent strategies to decrease ischemic events.

Dr. Bakaeen, from the Cleveland Clinic, told this news organization they don’t want a public battle over the data like the one that befell the EXCEL trial, and that it’s entirely possible the investigators might have inadvertently upgraded all the Duke score assignments by 1.

A systematic error, however, is more plausible than a formatting error, he said, because Supplemental tables 1 and 2 correspond exactly to the Duke 1 to Duke 7 sequence, suggesting the tables are correct and that the error might have occurred downstream, including in the manuscript.

The numbers should be consistent across all the ISCHEMIA manuscripts, Dr. Bakaeen added, but currently “don’t add up,” even after adjustment for different denominators, and especially for participants with left main disease.

They hope that publication of their letter, he said, will convince the authors to publicly share the data for patients in each of the seven modified Duke categories.

Lead author of the ISCHEMIA substudy, Harmony Reynolds, MD, New York (N.Y.) University Langone Health, told this news organization via email that as a result of a “formatting error in the transfer of data from the statistical output file to a Word document, data in Supplemental tables 1 and 2 were incorrect.”

She explained that they planned to present six, not seven, rows for the Duke score in the tables, collapsing the first two categories of nonobstructive disease (Duke 1-2), as they were in all other tables and figures. However, the Supplemental tables had incorrect row headings and because the Word program is designed to fill all available rows, it inserted the data from the output file into a seven-row table shell, duplicating the values for row 1 in the last row for left main disease of at least 50%.

“The data were correctly presented in the main manuscript tables and figures and in the remainder of the supplement, with a total of 659 patients in the subset with modified Duke prognostic index category 6 on coronary CT angiography,” Dr. Reynolds said.

She noted that Circulation will issue a correction. In addition, “we are in the process of preparing the data for public sharing soon. The data will include the Duke prognostic score at all levels.”

Circulation editor-in-chief Joseph A. Hill, MD, PhD, chief of cardiology at UT Southwestern Medical Center, Dallas, declined to be interviewed but confirmed via email that Dr. Bakaeen and Dr. Sabik’s letter and the correction will be published the week of May 16.

As for the delay, he said, “I received their reach-out just over 1 week ago, and per protocol, we conducted an internal evaluation of their allegations, which took a bit of time.”
 

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

The U.S. Food and Drug Administration has approved the Onyx Frontier drug-eluting stent (DES) to treat patients with coronary artery disease, the device manufacturer, Medtronic, announced today.

The Onyx Frontier shares the same stent platform and clinical indications as the previous-generation Resolute Onyx zotarolimus-eluting stent, including the most recent approval for patients at high risk of bleeding who may benefit from just 1 month dual-antiplatelet therapy.

“Meaningful design changes, including increased catheter flexibility, an innovative dual-layer balloon technology and a lower crossing profile led to a 16% improvement in deliverability with Onyx Frontier vs. the previous generation Resolute Onyx DES,” Medtronic said in a news release.

Onyx Frontier also offers a broad size matrix to treat more patients, and joins the Resolute Onyx as the only 2-mm DES available in the United States, the company noted. The stent is available in 4.5- to 5-mm sizes that can be expanded to 6 mm, specifically designed to support extra-large vessels.

The Onyx Frontier DES is pending CE Mark in Europe.

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

The U.S. Food and Drug Administration has approved the Onyx Frontier drug-eluting stent (DES) to treat patients with coronary artery disease, the device manufacturer, Medtronic, announced today.

The Onyx Frontier shares the same stent platform and clinical indications as the previous-generation Resolute Onyx zotarolimus-eluting stent, including the most recent approval for patients at high risk of bleeding who may benefit from just 1 month dual-antiplatelet therapy.

“Meaningful design changes, including increased catheter flexibility, an innovative dual-layer balloon technology and a lower crossing profile led to a 16% improvement in deliverability with Onyx Frontier vs. the previous generation Resolute Onyx DES,” Medtronic said in a news release.

Onyx Frontier also offers a broad size matrix to treat more patients, and joins the Resolute Onyx as the only 2-mm DES available in the United States, the company noted. The stent is available in 4.5- to 5-mm sizes that can be expanded to 6 mm, specifically designed to support extra-large vessels.

The Onyx Frontier DES is pending CE Mark in Europe.

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

The U.S. Food and Drug Administration has approved the Onyx Frontier drug-eluting stent (DES) to treat patients with coronary artery disease, the device manufacturer, Medtronic, announced today.

The Onyx Frontier shares the same stent platform and clinical indications as the previous-generation Resolute Onyx zotarolimus-eluting stent, including the most recent approval for patients at high risk of bleeding who may benefit from just 1 month dual-antiplatelet therapy.

“Meaningful design changes, including increased catheter flexibility, an innovative dual-layer balloon technology and a lower crossing profile led to a 16% improvement in deliverability with Onyx Frontier vs. the previous generation Resolute Onyx DES,” Medtronic said in a news release.

Onyx Frontier also offers a broad size matrix to treat more patients, and joins the Resolute Onyx as the only 2-mm DES available in the United States, the company noted. The stent is available in 4.5- to 5-mm sizes that can be expanded to 6 mm, specifically designed to support extra-large vessels.

The Onyx Frontier DES is pending CE Mark in Europe.

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

Reduced exercise capacity and peak ventilation were significant predictors of early mortality in adults with chronic obstructive pulmonary disease, based on data from 126 individuals.

Cardiopulmonary exercise testing (CPET) is a common assessment for cardiorespiratory disease patients, but its role as a predictor of clinically relevant outcomes in chronic obstructive pulmonary disease (COPD) has not been investigated, and data on changes in exercise capacity over time in COPD patients are limited, wrote Cassia da Luz Goulart, MD, of the Federal University of São Carlos, Brazil, and colleagues.

The researchers hypothesized that CPET threshold values could be used as predictors of mortality in COPD.

In a prospective study published in Respiratory Medicine, the researchers identified 126 adults with COPD who were followed for 42 months. At study entry, each patient completed a clinical evaluation, followed by a pulmonary function test and CPET. The average age of the patients was 65 years, and 73% were men. All patients were on optimal medical management for COPD.

The researchers recorded data on peak oxygen consumption (VO₂, mL/min), VCO₂ (mL/min), minute ventilation (VE, L/min), the oxygen uptake efficiency slope (OUES), and ventilatory efficiency (the VE/VCO₂ slope).

The participants performed CPET on a cycle ergometer, with breath-by-breath analysis measured throughout the test using a computer-based system.

A total of 48 patients (38%) died during the 42-month follow-up period. Overall, the significant predictors of mortality were VE/VCO₂ slope of 30 or higher, peak VE of 25.7 L/min, and peak VO₂ ≤ 13.8 mLO₂ kg^–1 min^–1 were strong predictors of mortality in COPD patients in a Cox regression analysis.

When comparing the 78 survivors to the 48 nonsurvivors, the researchers found that the nonsurvivors were significantly more likely to be women, with worse lung function, inspiratory muscle weakness, and poorer CPET responses (P < .050 for all).

“The VE peak response is directly related to the FEV₁ in COPD patients, factors such as dyspnea and increased leg discomfort negatively impact the VE response during exercise,” the researchers wrote in their discussion of the findings. In this context, our results may hold clinical utility in refining the prognostic accuracy when a patient with COPD has a VE peak ≤ 25.7 L/min,” they explained.

The study findings were limited by the inability to assess complete pulmonary function in the COPD patients, and the assessment only of three CPET measures, the researchers noted.

However, the results support the use of CPET as a clinical assessment tool for COPD patients, they said. “Moreover, therapeutic approaches, such as cardiopulmonary rehabilitation, may consider focusing on improving these metabolic and ventilatory markers as an indicator of clinical improvement and prognosis in patients with COPD,” they added.

The study was supported by the Fundação de Amparo a Pesquisa do Estado de São Paulo, Brazil, and by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-Brasil. The researchers had no financial conflicts to disclose.

Reduced exercise capacity and peak ventilation were significant predictors of early mortality in adults with chronic obstructive pulmonary disease, based on data from 126 individuals.

Cardiopulmonary exercise testing (CPET) is a common assessment for cardiorespiratory disease patients, but its role as a predictor of clinically relevant outcomes in chronic obstructive pulmonary disease (COPD) has not been investigated, and data on changes in exercise capacity over time in COPD patients are limited, wrote Cassia da Luz Goulart, MD, of the Federal University of São Carlos, Brazil, and colleagues.

The researchers hypothesized that CPET threshold values could be used as predictors of mortality in COPD.

In a prospective study published in Respiratory Medicine, the researchers identified 126 adults with COPD who were followed for 42 months. At study entry, each patient completed a clinical evaluation, followed by a pulmonary function test and CPET. The average age of the patients was 65 years, and 73% were men. All patients were on optimal medical management for COPD.

The researchers recorded data on peak oxygen consumption (VO₂, mL/min), VCO₂ (mL/min), minute ventilation (VE, L/min), the oxygen uptake efficiency slope (OUES), and ventilatory efficiency (the VE/VCO₂ slope).

The participants performed CPET on a cycle ergometer, with breath-by-breath analysis measured throughout the test using a computer-based system.

A total of 48 patients (38%) died during the 42-month follow-up period. Overall, the significant predictors of mortality were VE/VCO₂ slope of 30 or higher, peak VE of 25.7 L/min, and peak VO₂ ≤ 13.8 mLO₂ kg^–1 min^–1 were strong predictors of mortality in COPD patients in a Cox regression analysis.

When comparing the 78 survivors to the 48 nonsurvivors, the researchers found that the nonsurvivors were significantly more likely to be women, with worse lung function, inspiratory muscle weakness, and poorer CPET responses (P < .050 for all).

“The VE peak response is directly related to the FEV₁ in COPD patients, factors such as dyspnea and increased leg discomfort negatively impact the VE response during exercise,” the researchers wrote in their discussion of the findings. In this context, our results may hold clinical utility in refining the prognostic accuracy when a patient with COPD has a VE peak ≤ 25.7 L/min,” they explained.

The study findings were limited by the inability to assess complete pulmonary function in the COPD patients, and the assessment only of three CPET measures, the researchers noted.

However, the results support the use of CPET as a clinical assessment tool for COPD patients, they said. “Moreover, therapeutic approaches, such as cardiopulmonary rehabilitation, may consider focusing on improving these metabolic and ventilatory markers as an indicator of clinical improvement and prognosis in patients with COPD,” they added.

The study was supported by the Fundação de Amparo a Pesquisa do Estado de São Paulo, Brazil, and by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-Brasil. The researchers had no financial conflicts to disclose.

Reduced exercise capacity and peak ventilation were significant predictors of early mortality in adults with chronic obstructive pulmonary disease, based on data from 126 individuals.

Cardiopulmonary exercise testing (CPET) is a common assessment for cardiorespiratory disease patients, but its role as a predictor of clinically relevant outcomes in chronic obstructive pulmonary disease (COPD) has not been investigated, and data on changes in exercise capacity over time in COPD patients are limited, wrote Cassia da Luz Goulart, MD, of the Federal University of São Carlos, Brazil, and colleagues.

The researchers hypothesized that CPET threshold values could be used as predictors of mortality in COPD.

In a prospective study published in Respiratory Medicine, the researchers identified 126 adults with COPD who were followed for 42 months. At study entry, each patient completed a clinical evaluation, followed by a pulmonary function test and CPET. The average age of the patients was 65 years, and 73% were men. All patients were on optimal medical management for COPD.

The researchers recorded data on peak oxygen consumption (VO₂, mL/min), VCO₂ (mL/min), minute ventilation (VE, L/min), the oxygen uptake efficiency slope (OUES), and ventilatory efficiency (the VE/VCO₂ slope).

The participants performed CPET on a cycle ergometer, with breath-by-breath analysis measured throughout the test using a computer-based system.

A total of 48 patients (38%) died during the 42-month follow-up period. Overall, the significant predictors of mortality were VE/VCO₂ slope of 30 or higher, peak VE of 25.7 L/min, and peak VO₂ ≤ 13.8 mLO₂ kg^–1 min^–1 were strong predictors of mortality in COPD patients in a Cox regression analysis.

When comparing the 78 survivors to the 48 nonsurvivors, the researchers found that the nonsurvivors were significantly more likely to be women, with worse lung function, inspiratory muscle weakness, and poorer CPET responses (P < .050 for all).

“The VE peak response is directly related to the FEV₁ in COPD patients, factors such as dyspnea and increased leg discomfort negatively impact the VE response during exercise,” the researchers wrote in their discussion of the findings. In this context, our results may hold clinical utility in refining the prognostic accuracy when a patient with COPD has a VE peak ≤ 25.7 L/min,” they explained.

The study findings were limited by the inability to assess complete pulmonary function in the COPD patients, and the assessment only of three CPET measures, the researchers noted.

However, the results support the use of CPET as a clinical assessment tool for COPD patients, they said. “Moreover, therapeutic approaches, such as cardiopulmonary rehabilitation, may consider focusing on improving these metabolic and ventilatory markers as an indicator of clinical improvement and prognosis in patients with COPD,” they added.

The study was supported by the Fundação de Amparo a Pesquisa do Estado de São Paulo, Brazil, and by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-Brasil. The researchers had no financial conflicts to disclose.

Espresso consumption is associated with higher total cholesterol levels, a population-based, cross-sectional study suggests.

Elevations in serum total cholesterol level were significantly linked to espresso consumption, particularly in men, Åsne Lirhus Svatun, of the Arctic University of Norway, Tromsø, and colleagues reported.

Drinking boiled/plunger coffee was associated with significantly higher serum total cholesterol levels in women and men. There was a significant relationship between filtered coffee consumption and total cholesterol, but only among women, the researchers reported.

SorJongAng/Thinkstock.com

“Doctors could become mindful of asking about coffee consumption when taking up the history of patients with elevated serum cholesterol,” study author Maja-Lisa Løchen, MD, PhD, of the Arctic University of Norway, said in an interview.

“Guiding patients to change from plunger coffee or other unfiltered coffee types to filtered or instant coffee could be a part of a lifestyle intervention to lower serum cholesterol levels.”

The results were published online in the journal Open Heart.

Previous studies of the relationship between serum cholesterol and espresso have had varying outcomes, the researchers noted.

Given that coffee consumption is high worldwide, even slight health effects can have substantial health consequences, the researchers noted. “Coffee was included for the first time in the 2021 ESC [European Society of Cardiology] guidelines on cardiovascular disease prevention in clinical practice. Increased knowledge on espresso coffee’s association with serum cholesterol will improve the recommendations regarding coffee consumption.”

“I don’t think that the findings in this paper are necessarily enough to change any advice about coffee,” said David Kao, MD, an associate professor medicine at the University of Colorado at Denver, Aurora, in commenting on the findings. “This is partly because the most important thing at the end of the day is whether subsequent events like heart attack or stroke increased or decreased. This analysis was not designed to answer that question.”

“If one has to choose between this study, which would suggest to drink less coffee to maintain low cholesterol, and the others, which would suggest increasing coffee consumption might reduce risk of multiple kinds of CVD, one should choose the latter,” Dr. Kao concluded.

In the current study, the investigators assessed 21,083 participants in the Tromsø Study in Northern Norway. The mean age of the participants was 56.4 years. Using multivariable linear regression, the researchers compared the relationship between each level of coffee consumption with no coffee consumption as the reference point and serum total cholesterol as the dependent variable. They tested for sex differences and adjusted for relevant covariates.

The findings indicate that drinking three to five cups of espresso each day was significantly linked with greater serum total cholesterol by 0.16 mmol/L (95% confidence interval, 0.07-0.24) for men and by 0.09 mmol/L (95% CI, 0.01-0.17) for women in comparison with participants who did not drink espresso daily.

Compared with individuals who did not drink plunger/boiled coffee, consumption of six or more cups of plunger/boiled coffee each day was linked with elevated serum total cholesterol levels by 0.23 mmol/L (95% CI, 0.08-0.38) for men and 0.30 mmol/L (95% CI, 0.13-0.48) for women.

Notably, for women but not men, there was an increase in serum total cholesterol of 0.11 mmol/L (95% CI, 0.03-0.19) in association with drinking six or more cups of filtered coffee per day.

When excluding participants who did not drink instant coffee, drinking instant coffee yielded a significant linear pattern for both men and women, but there was not a dose-dependent association.

These data show that sex differences were significant for every coffee type except plunger/boiled coffee, the authors noted.

Limitations of the study include its cross-sectional design; lack of generalizability of the data, given that the cohort primarily consisted of elderly adults and middle-aged White persons; and the fact that the study did not adjust for all confounding variables, the researchers noted.

Also among the study’s limitations were that some data were self-reported, and the missing indicator approach was implemented to assess data, the authors added.

Future research efforts should focus on following this cohort over many years to determine how consumption of various types of coffee is linked with events such as heart failure, stroke, and myocardial infarction. This insight would be important in offering guidance on whether the style of coffee preparation matters, concluded Dr. Kao.

The study was supported by a number of sources, including the Arctic University of Norway and the Northern Norway Regional Health Authority. The study investigators reported no conflicts of interest.

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

Espresso consumption is associated with higher total cholesterol levels, a population-based, cross-sectional study suggests.

Elevations in serum total cholesterol level were significantly linked to espresso consumption, particularly in men, Åsne Lirhus Svatun, of the Arctic University of Norway, Tromsø, and colleagues reported.

Drinking boiled/plunger coffee was associated with significantly higher serum total cholesterol levels in women and men. There was a significant relationship between filtered coffee consumption and total cholesterol, but only among women, the researchers reported.

SorJongAng/Thinkstock.com

“Doctors could become mindful of asking about coffee consumption when taking up the history of patients with elevated serum cholesterol,” study author Maja-Lisa Løchen, MD, PhD, of the Arctic University of Norway, said in an interview.

“Guiding patients to change from plunger coffee or other unfiltered coffee types to filtered or instant coffee could be a part of a lifestyle intervention to lower serum cholesterol levels.”

The results were published online in the journal Open Heart.

Previous studies of the relationship between serum cholesterol and espresso have had varying outcomes, the researchers noted.

Given that coffee consumption is high worldwide, even slight health effects can have substantial health consequences, the researchers noted. “Coffee was included for the first time in the 2021 ESC [European Society of Cardiology] guidelines on cardiovascular disease prevention in clinical practice. Increased knowledge on espresso coffee’s association with serum cholesterol will improve the recommendations regarding coffee consumption.”

“I don’t think that the findings in this paper are necessarily enough to change any advice about coffee,” said David Kao, MD, an associate professor medicine at the University of Colorado at Denver, Aurora, in commenting on the findings. “This is partly because the most important thing at the end of the day is whether subsequent events like heart attack or stroke increased or decreased. This analysis was not designed to answer that question.”

“If one has to choose between this study, which would suggest to drink less coffee to maintain low cholesterol, and the others, which would suggest increasing coffee consumption might reduce risk of multiple kinds of CVD, one should choose the latter,” Dr. Kao concluded.

In the current study, the investigators assessed 21,083 participants in the Tromsø Study in Northern Norway. The mean age of the participants was 56.4 years. Using multivariable linear regression, the researchers compared the relationship between each level of coffee consumption with no coffee consumption as the reference point and serum total cholesterol as the dependent variable. They tested for sex differences and adjusted for relevant covariates.

The findings indicate that drinking three to five cups of espresso each day was significantly linked with greater serum total cholesterol by 0.16 mmol/L (95% confidence interval, 0.07-0.24) for men and by 0.09 mmol/L (95% CI, 0.01-0.17) for women in comparison with participants who did not drink espresso daily.

Compared with individuals who did not drink plunger/boiled coffee, consumption of six or more cups of plunger/boiled coffee each day was linked with elevated serum total cholesterol levels by 0.23 mmol/L (95% CI, 0.08-0.38) for men and 0.30 mmol/L (95% CI, 0.13-0.48) for women.

Notably, for women but not men, there was an increase in serum total cholesterol of 0.11 mmol/L (95% CI, 0.03-0.19) in association with drinking six or more cups of filtered coffee per day.

When excluding participants who did not drink instant coffee, drinking instant coffee yielded a significant linear pattern for both men and women, but there was not a dose-dependent association.

These data show that sex differences were significant for every coffee type except plunger/boiled coffee, the authors noted.

Limitations of the study include its cross-sectional design; lack of generalizability of the data, given that the cohort primarily consisted of elderly adults and middle-aged White persons; and the fact that the study did not adjust for all confounding variables, the researchers noted.

Also among the study’s limitations were that some data were self-reported, and the missing indicator approach was implemented to assess data, the authors added.

Future research efforts should focus on following this cohort over many years to determine how consumption of various types of coffee is linked with events such as heart failure, stroke, and myocardial infarction. This insight would be important in offering guidance on whether the style of coffee preparation matters, concluded Dr. Kao.

The study was supported by a number of sources, including the Arctic University of Norway and the Northern Norway Regional Health Authority. The study investigators reported no conflicts of interest.

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

Espresso consumption is associated with higher total cholesterol levels, a population-based, cross-sectional study suggests.

Elevations in serum total cholesterol level were significantly linked to espresso consumption, particularly in men, Åsne Lirhus Svatun, of the Arctic University of Norway, Tromsø, and colleagues reported.

Drinking boiled/plunger coffee was associated with significantly higher serum total cholesterol levels in women and men. There was a significant relationship between filtered coffee consumption and total cholesterol, but only among women, the researchers reported.

SorJongAng/Thinkstock.com

“Doctors could become mindful of asking about coffee consumption when taking up the history of patients with elevated serum cholesterol,” study author Maja-Lisa Løchen, MD, PhD, of the Arctic University of Norway, said in an interview.

“Guiding patients to change from plunger coffee or other unfiltered coffee types to filtered or instant coffee could be a part of a lifestyle intervention to lower serum cholesterol levels.”

The results were published online in the journal Open Heart.

Previous studies of the relationship between serum cholesterol and espresso have had varying outcomes, the researchers noted.

Given that coffee consumption is high worldwide, even slight health effects can have substantial health consequences, the researchers noted. “Coffee was included for the first time in the 2021 ESC [European Society of Cardiology] guidelines on cardiovascular disease prevention in clinical practice. Increased knowledge on espresso coffee’s association with serum cholesterol will improve the recommendations regarding coffee consumption.”

“I don’t think that the findings in this paper are necessarily enough to change any advice about coffee,” said David Kao, MD, an associate professor medicine at the University of Colorado at Denver, Aurora, in commenting on the findings. “This is partly because the most important thing at the end of the day is whether subsequent events like heart attack or stroke increased or decreased. This analysis was not designed to answer that question.”

“If one has to choose between this study, which would suggest to drink less coffee to maintain low cholesterol, and the others, which would suggest increasing coffee consumption might reduce risk of multiple kinds of CVD, one should choose the latter,” Dr. Kao concluded.

In the current study, the investigators assessed 21,083 participants in the Tromsø Study in Northern Norway. The mean age of the participants was 56.4 years. Using multivariable linear regression, the researchers compared the relationship between each level of coffee consumption with no coffee consumption as the reference point and serum total cholesterol as the dependent variable. They tested for sex differences and adjusted for relevant covariates.

The findings indicate that drinking three to five cups of espresso each day was significantly linked with greater serum total cholesterol by 0.16 mmol/L (95% confidence interval, 0.07-0.24) for men and by 0.09 mmol/L (95% CI, 0.01-0.17) for women in comparison with participants who did not drink espresso daily.

Compared with individuals who did not drink plunger/boiled coffee, consumption of six or more cups of plunger/boiled coffee each day was linked with elevated serum total cholesterol levels by 0.23 mmol/L (95% CI, 0.08-0.38) for men and 0.30 mmol/L (95% CI, 0.13-0.48) for women.

Notably, for women but not men, there was an increase in serum total cholesterol of 0.11 mmol/L (95% CI, 0.03-0.19) in association with drinking six or more cups of filtered coffee per day.

When excluding participants who did not drink instant coffee, drinking instant coffee yielded a significant linear pattern for both men and women, but there was not a dose-dependent association.

These data show that sex differences were significant for every coffee type except plunger/boiled coffee, the authors noted.

Limitations of the study include its cross-sectional design; lack of generalizability of the data, given that the cohort primarily consisted of elderly adults and middle-aged White persons; and the fact that the study did not adjust for all confounding variables, the researchers noted.

Also among the study’s limitations were that some data were self-reported, and the missing indicator approach was implemented to assess data, the authors added.

Future research efforts should focus on following this cohort over many years to determine how consumption of various types of coffee is linked with events such as heart failure, stroke, and myocardial infarction. This insight would be important in offering guidance on whether the style of coffee preparation matters, concluded Dr. Kao.

The study was supported by a number of sources, including the Arctic University of Norway and the Northern Norway Regional Health Authority. The study investigators reported no conflicts of interest.

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

Signs of cardiometabolic damage in children who are overweight appear as early as 6-8 years of age, but were not evident in preschoolers, providing a window of opportunity for intervention, show the latest results from a long-running Danish study of childhood weight.

The proportion of children who were overweight (nearly 14% in 2015) was similar between the two groups – those of preschool age (2-5 years) and school age (6-8 years) – but only the latter showed significant signs of cardiometabolic abnormalities.

The results, published in Obesity Research & Clinical Practice, are the latest in a series of many findings from the HOLBAEK study (formerly known as The Danish Childhood Obesity Biobank) that have emerged since it began in 2007. They were presented, along with a meta-analysis of much of their work, at the European Congress on Obesity (ECO) 2022.

“When comparing children with and without overweight, there were only barely significant differences among the preschool children,” said investigator Christine Frithioff-Bøjsøe, MD, but in contrast, “the school children with overweight exhibited significantly higher systolic blood pressure, glucose, insulin, and higher HDL cholesterol,” among other markers, she noted.

“Detection needs to start as early as age 2-5 years because if you wait just a few years longer these children will show early signs of disease starting to take hold. This could provide a critical window to detect and manage overweight,” said Frithioff-Bøjsøe, PhD, of the Children’s Obesity Clinic, Copenhagen University, Hospital Holbaek, Denmark.

Asked to comment, Aaron S. Kelly, PhD, professor of pediatrics, codirector, University of Minnesota Center for Pediatric Obesity Medicine in Minneapolis, said: “Recent results from HOLBAEK highlight the critical importance of identifying obesity early in life, before its complications spring up.

“Ideally, we should be in the business of managing and reducing excess adiposity as soon as it surfaces with the goal of preventing the onset of cardiometabolic risk factors, not watchful waiting and hoping for the best.”
 

Routine dental visits checked overweight

In the newest study, the researchers trained dental assistants to measure weight and height and carried out body mass index assessments during routine appointments.

A total of 335 preschool and 657 school-age children were recruited for the study. Of these, 40% attended additional hospital-based examinations including blood pressure measurement and a blood sample. Children were reexamined approximately 1 year later.

Systolic blood pressure, for example, was significantly higher in 6- to 8-year-olds with overweight compared to those of normal weight (P = .001). There was no significant difference between systolic blood pressure of 2.5- to 5-year-olds without and with overweight.

Likewise, with insulin resistance, there was no significant difference between preschoolers with and without overweight. However, in schoolchildren, homoeostasis model of assessment–insulin resistance (HOMA-IR) was significantly higher in those with overweight, at 2.2, compared to those without, at 0.9 (P < .001).

Also, during follow-up (around a year later), the prevalence of overweight did not change in preschool children but increased from 13.7% to 17.0% in schoolchildren.

The researchers noted that, in Europe, it is the primary health care sector that has continuous contact with the pediatric population, with the potential for early evaluation of children at risk. Their decision to use dental health care assistants to assess weight in this particular study is novel, but feasible, they observed.
 

Danish model for treating overweight and obesity is ‘game-changing’

As part of the HOLBAEK initiative, clinical data and biological samples have been collected from children and adolescents receiving treatment at The Children’s Obesity Clinic, Holbaek Hospital, using a population-based cohort as a reference group. Data have been collected on about 8,000 children and adolescents so far.

Jens-Christian Holm, PhD, along with colleague and research assistant Maria Frauland, both from Copenhagen University, Hospital Holbaek, presented a review of the HOLBAEK studies (2007-2021) at ECO 2022. They said the results highlight the importance of taking an integrated approach to managing children and adolescents with obesity.

The review, which included 82 papers, found a wide variety of obesity-related complications already present at a young age in some of the cross-sectional studies, including dyslipidemia in 28% of children with obesity, hepatic steatosis in 31%, obstructive sleep apnea in 45%, and prehypertension or hypertension in 52%.

The family-based interventional weight management programs adopted by HOLBAEK showed a 75% reduction in the “degree of obesity,” which comprised a measure of dyslipidemia, hypertension, hepatic steatosis, sleep apnea, and parental obesity.

“The HOLBAEK method is a holistic approach where we integrate everything,” Dr. Holm told this news organization.

Ms. Frauland said: “The HOLBAEK study has provided important insights into childhood overweight. It has highlighted that obesity is a serious multisystem disease that can be managed and treated effectively, reducing the degree of overweight and improving overweight-related complications.”

Dr. Kelly, the U.S. pediatrician, applauded the HOLBAEK philosophy, which emphasizes that obesity is not the fault of the child or parent, but rather the manifestation of dysregulated energy metabolism. “The recognition that obesity is a biologically driven, chronic, refractory, and relapsing disease is interwoven into the approach, which shifts the responsibility to the care provider for ensuring positive outcomes of treatment.

“Highlighting this fact to the parents and child can be game-changing since it removes the blame and shame associated with obesity and unburdens the family by framing the problem in a different light,” Dr. Kelly stressed.

Dr. Frithioff-Bøjsøe has reported no relevant financial relationships. Dr. Holm has an obesity management company called Holm. Dr. Kelly serves as an unpaid consultant for Novo Nordisk, Vivus, Eli Lilly, and Boehringer Ingelheim and receives donated drug/placebo from Vivus for a clinical trial funded by the National Institutes of Health.

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

Signs of cardiometabolic damage in children who are overweight appear as early as 6-8 years of age, but were not evident in preschoolers, providing a window of opportunity for intervention, show the latest results from a long-running Danish study of childhood weight.

The proportion of children who were overweight (nearly 14% in 2015) was similar between the two groups – those of preschool age (2-5 years) and school age (6-8 years) – but only the latter showed significant signs of cardiometabolic abnormalities.

The results, published in Obesity Research & Clinical Practice, are the latest in a series of many findings from the HOLBAEK study (formerly known as The Danish Childhood Obesity Biobank) that have emerged since it began in 2007. They were presented, along with a meta-analysis of much of their work, at the European Congress on Obesity (ECO) 2022.

“When comparing children with and without overweight, there were only barely significant differences among the preschool children,” said investigator Christine Frithioff-Bøjsøe, MD, but in contrast, “the school children with overweight exhibited significantly higher systolic blood pressure, glucose, insulin, and higher HDL cholesterol,” among other markers, she noted.

“Detection needs to start as early as age 2-5 years because if you wait just a few years longer these children will show early signs of disease starting to take hold. This could provide a critical window to detect and manage overweight,” said Frithioff-Bøjsøe, PhD, of the Children’s Obesity Clinic, Copenhagen University, Hospital Holbaek, Denmark.

Asked to comment, Aaron S. Kelly, PhD, professor of pediatrics, codirector, University of Minnesota Center for Pediatric Obesity Medicine in Minneapolis, said: “Recent results from HOLBAEK highlight the critical importance of identifying obesity early in life, before its complications spring up.

“Ideally, we should be in the business of managing and reducing excess adiposity as soon as it surfaces with the goal of preventing the onset of cardiometabolic risk factors, not watchful waiting and hoping for the best.”
 

Routine dental visits checked overweight

In the newest study, the researchers trained dental assistants to measure weight and height and carried out body mass index assessments during routine appointments.

A total of 335 preschool and 657 school-age children were recruited for the study. Of these, 40% attended additional hospital-based examinations including blood pressure measurement and a blood sample. Children were reexamined approximately 1 year later.

Systolic blood pressure, for example, was significantly higher in 6- to 8-year-olds with overweight compared to those of normal weight (P = .001). There was no significant difference between systolic blood pressure of 2.5- to 5-year-olds without and with overweight.

Likewise, with insulin resistance, there was no significant difference between preschoolers with and without overweight. However, in schoolchildren, homoeostasis model of assessment–insulin resistance (HOMA-IR) was significantly higher in those with overweight, at 2.2, compared to those without, at 0.9 (P < .001).

Also, during follow-up (around a year later), the prevalence of overweight did not change in preschool children but increased from 13.7% to 17.0% in schoolchildren.

The researchers noted that, in Europe, it is the primary health care sector that has continuous contact with the pediatric population, with the potential for early evaluation of children at risk. Their decision to use dental health care assistants to assess weight in this particular study is novel, but feasible, they observed.
 

Danish model for treating overweight and obesity is ‘game-changing’

As part of the HOLBAEK initiative, clinical data and biological samples have been collected from children and adolescents receiving treatment at The Children’s Obesity Clinic, Holbaek Hospital, using a population-based cohort as a reference group. Data have been collected on about 8,000 children and adolescents so far.

Jens-Christian Holm, PhD, along with colleague and research assistant Maria Frauland, both from Copenhagen University, Hospital Holbaek, presented a review of the HOLBAEK studies (2007-2021) at ECO 2022. They said the results highlight the importance of taking an integrated approach to managing children and adolescents with obesity.

The review, which included 82 papers, found a wide variety of obesity-related complications already present at a young age in some of the cross-sectional studies, including dyslipidemia in 28% of children with obesity, hepatic steatosis in 31%, obstructive sleep apnea in 45%, and prehypertension or hypertension in 52%.

The family-based interventional weight management programs adopted by HOLBAEK showed a 75% reduction in the “degree of obesity,” which comprised a measure of dyslipidemia, hypertension, hepatic steatosis, sleep apnea, and parental obesity.

“The HOLBAEK method is a holistic approach where we integrate everything,” Dr. Holm told this news organization.

Ms. Frauland said: “The HOLBAEK study has provided important insights into childhood overweight. It has highlighted that obesity is a serious multisystem disease that can be managed and treated effectively, reducing the degree of overweight and improving overweight-related complications.”

Dr. Kelly, the U.S. pediatrician, applauded the HOLBAEK philosophy, which emphasizes that obesity is not the fault of the child or parent, but rather the manifestation of dysregulated energy metabolism. “The recognition that obesity is a biologically driven, chronic, refractory, and relapsing disease is interwoven into the approach, which shifts the responsibility to the care provider for ensuring positive outcomes of treatment.

“Highlighting this fact to the parents and child can be game-changing since it removes the blame and shame associated with obesity and unburdens the family by framing the problem in a different light,” Dr. Kelly stressed.

Dr. Frithioff-Bøjsøe has reported no relevant financial relationships. Dr. Holm has an obesity management company called Holm. Dr. Kelly serves as an unpaid consultant for Novo Nordisk, Vivus, Eli Lilly, and Boehringer Ingelheim and receives donated drug/placebo from Vivus for a clinical trial funded by the National Institutes of Health.

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

Signs of cardiometabolic damage in children who are overweight appear as early as 6-8 years of age, but were not evident in preschoolers, providing a window of opportunity for intervention, show the latest results from a long-running Danish study of childhood weight.

The proportion of children who were overweight (nearly 14% in 2015) was similar between the two groups – those of preschool age (2-5 years) and school age (6-8 years) – but only the latter showed significant signs of cardiometabolic abnormalities.

The results, published in Obesity Research & Clinical Practice, are the latest in a series of many findings from the HOLBAEK study (formerly known as The Danish Childhood Obesity Biobank) that have emerged since it began in 2007. They were presented, along with a meta-analysis of much of their work, at the European Congress on Obesity (ECO) 2022.

“When comparing children with and without overweight, there were only barely significant differences among the preschool children,” said investigator Christine Frithioff-Bøjsøe, MD, but in contrast, “the school children with overweight exhibited significantly higher systolic blood pressure, glucose, insulin, and higher HDL cholesterol,” among other markers, she noted.

“Detection needs to start as early as age 2-5 years because if you wait just a few years longer these children will show early signs of disease starting to take hold. This could provide a critical window to detect and manage overweight,” said Frithioff-Bøjsøe, PhD, of the Children’s Obesity Clinic, Copenhagen University, Hospital Holbaek, Denmark.

Asked to comment, Aaron S. Kelly, PhD, professor of pediatrics, codirector, University of Minnesota Center for Pediatric Obesity Medicine in Minneapolis, said: “Recent results from HOLBAEK highlight the critical importance of identifying obesity early in life, before its complications spring up.

“Ideally, we should be in the business of managing and reducing excess adiposity as soon as it surfaces with the goal of preventing the onset of cardiometabolic risk factors, not watchful waiting and hoping for the best.”
 

Routine dental visits checked overweight

In the newest study, the researchers trained dental assistants to measure weight and height and carried out body mass index assessments during routine appointments.

A total of 335 preschool and 657 school-age children were recruited for the study. Of these, 40% attended additional hospital-based examinations including blood pressure measurement and a blood sample. Children were reexamined approximately 1 year later.

Systolic blood pressure, for example, was significantly higher in 6- to 8-year-olds with overweight compared to those of normal weight (P = .001). There was no significant difference between systolic blood pressure of 2.5- to 5-year-olds without and with overweight.

Likewise, with insulin resistance, there was no significant difference between preschoolers with and without overweight. However, in schoolchildren, homoeostasis model of assessment–insulin resistance (HOMA-IR) was significantly higher in those with overweight, at 2.2, compared to those without, at 0.9 (P < .001).

Also, during follow-up (around a year later), the prevalence of overweight did not change in preschool children but increased from 13.7% to 17.0% in schoolchildren.

The researchers noted that, in Europe, it is the primary health care sector that has continuous contact with the pediatric population, with the potential for early evaluation of children at risk. Their decision to use dental health care assistants to assess weight in this particular study is novel, but feasible, they observed.
 

Danish model for treating overweight and obesity is ‘game-changing’

As part of the HOLBAEK initiative, clinical data and biological samples have been collected from children and adolescents receiving treatment at The Children’s Obesity Clinic, Holbaek Hospital, using a population-based cohort as a reference group. Data have been collected on about 8,000 children and adolescents so far.

Jens-Christian Holm, PhD, along with colleague and research assistant Maria Frauland, both from Copenhagen University, Hospital Holbaek, presented a review of the HOLBAEK studies (2007-2021) at ECO 2022. They said the results highlight the importance of taking an integrated approach to managing children and adolescents with obesity.

The review, which included 82 papers, found a wide variety of obesity-related complications already present at a young age in some of the cross-sectional studies, including dyslipidemia in 28% of children with obesity, hepatic steatosis in 31%, obstructive sleep apnea in 45%, and prehypertension or hypertension in 52%.

The family-based interventional weight management programs adopted by HOLBAEK showed a 75% reduction in the “degree of obesity,” which comprised a measure of dyslipidemia, hypertension, hepatic steatosis, sleep apnea, and parental obesity.

“The HOLBAEK method is a holistic approach where we integrate everything,” Dr. Holm told this news organization.

Ms. Frauland said: “The HOLBAEK study has provided important insights into childhood overweight. It has highlighted that obesity is a serious multisystem disease that can be managed and treated effectively, reducing the degree of overweight and improving overweight-related complications.”

Dr. Kelly, the U.S. pediatrician, applauded the HOLBAEK philosophy, which emphasizes that obesity is not the fault of the child or parent, but rather the manifestation of dysregulated energy metabolism. “The recognition that obesity is a biologically driven, chronic, refractory, and relapsing disease is interwoven into the approach, which shifts the responsibility to the care provider for ensuring positive outcomes of treatment.

“Highlighting this fact to the parents and child can be game-changing since it removes the blame and shame associated with obesity and unburdens the family by framing the problem in a different light,” Dr. Kelly stressed.

Dr. Frithioff-Bøjsøe has reported no relevant financial relationships. Dr. Holm has an obesity management company called Holm. Dr. Kelly serves as an unpaid consultant for Novo Nordisk, Vivus, Eli Lilly, and Boehringer Ingelheim and receives donated drug/placebo from Vivus for a clinical trial funded by the National Institutes of Health.

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

New research suggests physicians face a Herculean task to get Americans with atherosclerotic cardiovascular disease (ASCVD) to take high-intensity statins, despite multiple professional guidelines giving the therapy their highest level recommendation.

Results from more 600,000 commercially insured patients with established ASCVD showed:

• Only one in five patients (22.5%) were taking a high-intensity statin.
• 27.6% were taking a low- or moderate-intensity statin.
• One-half (49.9%) were not taking any statin.

“It’s embarrassing,” senior author Christopher B. Granger, MD, Duke Clinical Research Institute, Durham, N.C., told this news organization. “It should be embarrassing for anybody in health care that we do such a terrible job with something so simple and effective.”

The results were published in the Journal of the American College of Cardiology.

Statins have been shown to reduce the risk for ASCVD events by about 30%, with an added 15% reduction with a high-intensity formulation. The class I recommendation for high-intensity statin use in ASCVD patients younger than 75 years in the 2013 American College of Cardiology/American Heart Association cholesterol guidelines prompted a jump in prescriptions that plateaued by 2017.

A class II recommendation was added to the 2018 guideline update for high-intensity statins in adults older than 75 years with ASCVD. But underuse persists, despite falling prices with generic availability and initiatives to improve statin adoption, the authors noted.

“There are a lot of barriers for patients to statin use, including the misinformation on the Internet and elsewhere that statins have all kinds of side effects,” Dr. Granger said. “They have uncommon side effects, but when we look at it carefully, only about 10% of patients, even with statin intolerance, have true intolerance.”

Efforts are needed to better understand and address these barriers, particularly for younger and female patients, he noted.

In multivariate analyses, patients who were middle-aged (odds ratio, 2.66) or at least 75 years of age (OR, 2.09) were more than twice as likely as patients younger than 45 years to be on any statin.

Not surprisingly, women were 30% less likely than men to receive a statin (OR, 0.70), Dr. Granger said. A high Charlson comorbidity score (OR, 0.72) and peripheral artery disease (OR, 0.55) also reduced the odds of a statin prescription.

Among statin users, middle-aged (OR, 0.83) and older (OR, 0.44) patients were less likely to be on a high-intensity statin, as were women (OR, 0.68) and patients with peripheral artery disease (OR, 0.43).

Visiting a cardiologist in the previous 12 months, however, increased the odds a patient was on a high-intensity statin (OR, 1.21), as did the use of other LDL-cholesterol-lowering drugs (OR, 1.44).

“With no evidence of heterogeneity in efficacy by sex, ongoing work must not only address misperceptions and barriers to the prescription of high-intensity statins in women, but also further understand (and address) differences in tolerability, which may be related to sex-based variation in statin metabolism,” wrote the authors, led by Adam J. Nelson, MBBS, MBA, MPH, also from Duke.

The study involved 601,934 patients (mean age, 67.5 years) who had a diagnosis of ASCVD between Jan. 31, 2018, and an index date of Jan. 31, 2019, and were enrolled in the HealthCore Integrated Research Environment database.

Two-thirds (70.9%) of patients visited a cardiologist in the 12 months prior to the index date, and three-fourths (81.3%) visited a primary care provider.

Pharmacy claims for the 12 months after the index date showed 82.8% of high-intensity users at index achieved coverage for at least 75% of days. Those with the least adherence (< 50% of days covered) included younger patients, as well as those with chronic kidney disease or depression.

“We need implementation research. What are the tools and the methods that we can use to improve the proportion of patients who are having the life-saving benefits from statins?” Dr. Granger said.

He noted that the team has submitted a National Institutes of Health grant to try to use pharmacists, as a mechanism within the context of health systems and payer systems, to improve the appropriate use of statins in a randomized trial. “I think that’s a win.”

Salim S. Virani, MD, PhD, Baylor College of Medicine, and Michael DeBakey VA Medical Center, Houston, and colleagues point out in a related editorial that the rates of statin usage in the study are “considerably lower” than in other contemporary studies, where about 80% and 50% of ASCVD patients are receiving statins and high-intensity statins, respectively.

Possible explanations are the use of rule-out codes, a short medication fill window from the index date, or issues with medication capture, they said. “Nevertheless, the findings are largely consistent with other work highlighting low use of statin therapy.”

The editorialists said social media, statin-related adverse effects, and therapeutic inertia are key drivers of non–guideline-concordant statin use. Possible solutions include improving guideline dissemination, leveraging team-based care, using smart clinical decision-support tools at the point of care, and identifying trustworthy and easily understood sources of information for patients.

“We can only hope that the fate of statin therapy is not repeated with sodium-glucose cotranspoerter-2 inhibitors or glucagon-like peptide-1 receptor agonists in another 30 years, or worse yet, that continued gaps in statin therapy use in patients with ASCVD persist 30 years from now,” Dr. Virani and colleagues concluded.

A sliver of optimism?

A research letter by Colantonio et al. in the same issue of JACC points to some positive steps, at least among patients having a myocardial infarction (MI). It reported that the percentage of patients who received a high-intensity statin as their first statin prescription 30 days after MI jumped from 30.7% in the first quarter of 2011 to 78.6% in the fourth quarter of 2019.

Similar increases were reported by race/ethnicity, despite statin use previously shown to be lower among non-Hispanic Black patients with ASCVD. In each calendar year, however, high-intensity statin therapy was lower among patients older than 75 years and among women.

Dr. Granger disclosed ties with Boehringer Ingelheim, Bristol Myers Squibb, Janssen Pharmaceuticals, Pfizer, AKROS, Apple, AstraZeneca, Daiichi Sankyo, Food and Drug Administration, GlaxoSmithKline, Medtronic Foundation, Novartis Pharmaceuticals, AbbVie, Bayer, Boston Scientific, CeleCor Therapeutics, Correvio, Espero BioPharma, Medscape, Medtronic, Merck, National Institutes of Health, Novo Nordisk, Rhoshan Pharmaceuticals, and Roche Diagnostics. Dr. Virani disclosed ties with the Department of Veterans Affairs, the National Institutes of Health, the World Heart Federation, and the Jooma and Tahir Family, and the American College of Cardiology.

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

New research suggests physicians face a Herculean task to get Americans with atherosclerotic cardiovascular disease (ASCVD) to take high-intensity statins, despite multiple professional guidelines giving the therapy their highest level recommendation.

Results from more 600,000 commercially insured patients with established ASCVD showed:

• Only one in five patients (22.5%) were taking a high-intensity statin.
• 27.6% were taking a low- or moderate-intensity statin.
• One-half (49.9%) were not taking any statin.

“It’s embarrassing,” senior author Christopher B. Granger, MD, Duke Clinical Research Institute, Durham, N.C., told this news organization. “It should be embarrassing for anybody in health care that we do such a terrible job with something so simple and effective.”

The results were published in the Journal of the American College of Cardiology.

Statins have been shown to reduce the risk for ASCVD events by about 30%, with an added 15% reduction with a high-intensity formulation. The class I recommendation for high-intensity statin use in ASCVD patients younger than 75 years in the 2013 American College of Cardiology/American Heart Association cholesterol guidelines prompted a jump in prescriptions that plateaued by 2017.

A class II recommendation was added to the 2018 guideline update for high-intensity statins in adults older than 75 years with ASCVD. But underuse persists, despite falling prices with generic availability and initiatives to improve statin adoption, the authors noted.

“There are a lot of barriers for patients to statin use, including the misinformation on the Internet and elsewhere that statins have all kinds of side effects,” Dr. Granger said. “They have uncommon side effects, but when we look at it carefully, only about 10% of patients, even with statin intolerance, have true intolerance.”

Efforts are needed to better understand and address these barriers, particularly for younger and female patients, he noted.

In multivariate analyses, patients who were middle-aged (odds ratio, 2.66) or at least 75 years of age (OR, 2.09) were more than twice as likely as patients younger than 45 years to be on any statin.

Not surprisingly, women were 30% less likely than men to receive a statin (OR, 0.70), Dr. Granger said. A high Charlson comorbidity score (OR, 0.72) and peripheral artery disease (OR, 0.55) also reduced the odds of a statin prescription.

Among statin users, middle-aged (OR, 0.83) and older (OR, 0.44) patients were less likely to be on a high-intensity statin, as were women (OR, 0.68) and patients with peripheral artery disease (OR, 0.43).

Visiting a cardiologist in the previous 12 months, however, increased the odds a patient was on a high-intensity statin (OR, 1.21), as did the use of other LDL-cholesterol-lowering drugs (OR, 1.44).

“With no evidence of heterogeneity in efficacy by sex, ongoing work must not only address misperceptions and barriers to the prescription of high-intensity statins in women, but also further understand (and address) differences in tolerability, which may be related to sex-based variation in statin metabolism,” wrote the authors, led by Adam J. Nelson, MBBS, MBA, MPH, also from Duke.

The study involved 601,934 patients (mean age, 67.5 years) who had a diagnosis of ASCVD between Jan. 31, 2018, and an index date of Jan. 31, 2019, and were enrolled in the HealthCore Integrated Research Environment database.

Two-thirds (70.9%) of patients visited a cardiologist in the 12 months prior to the index date, and three-fourths (81.3%) visited a primary care provider.

Pharmacy claims for the 12 months after the index date showed 82.8% of high-intensity users at index achieved coverage for at least 75% of days. Those with the least adherence (< 50% of days covered) included younger patients, as well as those with chronic kidney disease or depression.

“We need implementation research. What are the tools and the methods that we can use to improve the proportion of patients who are having the life-saving benefits from statins?” Dr. Granger said.

He noted that the team has submitted a National Institutes of Health grant to try to use pharmacists, as a mechanism within the context of health systems and payer systems, to improve the appropriate use of statins in a randomized trial. “I think that’s a win.”

Salim S. Virani, MD, PhD, Baylor College of Medicine, and Michael DeBakey VA Medical Center, Houston, and colleagues point out in a related editorial that the rates of statin usage in the study are “considerably lower” than in other contemporary studies, where about 80% and 50% of ASCVD patients are receiving statins and high-intensity statins, respectively.

Possible explanations are the use of rule-out codes, a short medication fill window from the index date, or issues with medication capture, they said. “Nevertheless, the findings are largely consistent with other work highlighting low use of statin therapy.”

The editorialists said social media, statin-related adverse effects, and therapeutic inertia are key drivers of non–guideline-concordant statin use. Possible solutions include improving guideline dissemination, leveraging team-based care, using smart clinical decision-support tools at the point of care, and identifying trustworthy and easily understood sources of information for patients.

“We can only hope that the fate of statin therapy is not repeated with sodium-glucose cotranspoerter-2 inhibitors or glucagon-like peptide-1 receptor agonists in another 30 years, or worse yet, that continued gaps in statin therapy use in patients with ASCVD persist 30 years from now,” Dr. Virani and colleagues concluded.

A sliver of optimism?

A research letter by Colantonio et al. in the same issue of JACC points to some positive steps, at least among patients having a myocardial infarction (MI). It reported that the percentage of patients who received a high-intensity statin as their first statin prescription 30 days after MI jumped from 30.7% in the first quarter of 2011 to 78.6% in the fourth quarter of 2019.

Similar increases were reported by race/ethnicity, despite statin use previously shown to be lower among non-Hispanic Black patients with ASCVD. In each calendar year, however, high-intensity statin therapy was lower among patients older than 75 years and among women.

Dr. Granger disclosed ties with Boehringer Ingelheim, Bristol Myers Squibb, Janssen Pharmaceuticals, Pfizer, AKROS, Apple, AstraZeneca, Daiichi Sankyo, Food and Drug Administration, GlaxoSmithKline, Medtronic Foundation, Novartis Pharmaceuticals, AbbVie, Bayer, Boston Scientific, CeleCor Therapeutics, Correvio, Espero BioPharma, Medscape, Medtronic, Merck, National Institutes of Health, Novo Nordisk, Rhoshan Pharmaceuticals, and Roche Diagnostics. Dr. Virani disclosed ties with the Department of Veterans Affairs, the National Institutes of Health, the World Heart Federation, and the Jooma and Tahir Family, and the American College of Cardiology.

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

New research suggests physicians face a Herculean task to get Americans with atherosclerotic cardiovascular disease (ASCVD) to take high-intensity statins, despite multiple professional guidelines giving the therapy their highest level recommendation.

Results from more 600,000 commercially insured patients with established ASCVD showed:

• Only one in five patients (22.5%) were taking a high-intensity statin.
• 27.6% were taking a low- or moderate-intensity statin.
• One-half (49.9%) were not taking any statin.

“It’s embarrassing,” senior author Christopher B. Granger, MD, Duke Clinical Research Institute, Durham, N.C., told this news organization. “It should be embarrassing for anybody in health care that we do such a terrible job with something so simple and effective.”

The results were published in the Journal of the American College of Cardiology.

Statins have been shown to reduce the risk for ASCVD events by about 30%, with an added 15% reduction with a high-intensity formulation. The class I recommendation for high-intensity statin use in ASCVD patients younger than 75 years in the 2013 American College of Cardiology/American Heart Association cholesterol guidelines prompted a jump in prescriptions that plateaued by 2017.

A class II recommendation was added to the 2018 guideline update for high-intensity statins in adults older than 75 years with ASCVD. But underuse persists, despite falling prices with generic availability and initiatives to improve statin adoption, the authors noted.

“There are a lot of barriers for patients to statin use, including the misinformation on the Internet and elsewhere that statins have all kinds of side effects,” Dr. Granger said. “They have uncommon side effects, but when we look at it carefully, only about 10% of patients, even with statin intolerance, have true intolerance.”

Efforts are needed to better understand and address these barriers, particularly for younger and female patients, he noted.

In multivariate analyses, patients who were middle-aged (odds ratio, 2.66) or at least 75 years of age (OR, 2.09) were more than twice as likely as patients younger than 45 years to be on any statin.

Not surprisingly, women were 30% less likely than men to receive a statin (OR, 0.70), Dr. Granger said. A high Charlson comorbidity score (OR, 0.72) and peripheral artery disease (OR, 0.55) also reduced the odds of a statin prescription.

Among statin users, middle-aged (OR, 0.83) and older (OR, 0.44) patients were less likely to be on a high-intensity statin, as were women (OR, 0.68) and patients with peripheral artery disease (OR, 0.43).

Visiting a cardiologist in the previous 12 months, however, increased the odds a patient was on a high-intensity statin (OR, 1.21), as did the use of other LDL-cholesterol-lowering drugs (OR, 1.44).

“With no evidence of heterogeneity in efficacy by sex, ongoing work must not only address misperceptions and barriers to the prescription of high-intensity statins in women, but also further understand (and address) differences in tolerability, which may be related to sex-based variation in statin metabolism,” wrote the authors, led by Adam J. Nelson, MBBS, MBA, MPH, also from Duke.

The study involved 601,934 patients (mean age, 67.5 years) who had a diagnosis of ASCVD between Jan. 31, 2018, and an index date of Jan. 31, 2019, and were enrolled in the HealthCore Integrated Research Environment database.

Two-thirds (70.9%) of patients visited a cardiologist in the 12 months prior to the index date, and three-fourths (81.3%) visited a primary care provider.

Pharmacy claims for the 12 months after the index date showed 82.8% of high-intensity users at index achieved coverage for at least 75% of days. Those with the least adherence (< 50% of days covered) included younger patients, as well as those with chronic kidney disease or depression.

“We need implementation research. What are the tools and the methods that we can use to improve the proportion of patients who are having the life-saving benefits from statins?” Dr. Granger said.

He noted that the team has submitted a National Institutes of Health grant to try to use pharmacists, as a mechanism within the context of health systems and payer systems, to improve the appropriate use of statins in a randomized trial. “I think that’s a win.”

Salim S. Virani, MD, PhD, Baylor College of Medicine, and Michael DeBakey VA Medical Center, Houston, and colleagues point out in a related editorial that the rates of statin usage in the study are “considerably lower” than in other contemporary studies, where about 80% and 50% of ASCVD patients are receiving statins and high-intensity statins, respectively.

Possible explanations are the use of rule-out codes, a short medication fill window from the index date, or issues with medication capture, they said. “Nevertheless, the findings are largely consistent with other work highlighting low use of statin therapy.”

The editorialists said social media, statin-related adverse effects, and therapeutic inertia are key drivers of non–guideline-concordant statin use. Possible solutions include improving guideline dissemination, leveraging team-based care, using smart clinical decision-support tools at the point of care, and identifying trustworthy and easily understood sources of information for patients.

“We can only hope that the fate of statin therapy is not repeated with sodium-glucose cotranspoerter-2 inhibitors or glucagon-like peptide-1 receptor agonists in another 30 years, or worse yet, that continued gaps in statin therapy use in patients with ASCVD persist 30 years from now,” Dr. Virani and colleagues concluded.

A sliver of optimism?

A research letter by Colantonio et al. in the same issue of JACC points to some positive steps, at least among patients having a myocardial infarction (MI). It reported that the percentage of patients who received a high-intensity statin as their first statin prescription 30 days after MI jumped from 30.7% in the first quarter of 2011 to 78.6% in the fourth quarter of 2019.

Similar increases were reported by race/ethnicity, despite statin use previously shown to be lower among non-Hispanic Black patients with ASCVD. In each calendar year, however, high-intensity statin therapy was lower among patients older than 75 years and among women.

Dr. Granger disclosed ties with Boehringer Ingelheim, Bristol Myers Squibb, Janssen Pharmaceuticals, Pfizer, AKROS, Apple, AstraZeneca, Daiichi Sankyo, Food and Drug Administration, GlaxoSmithKline, Medtronic Foundation, Novartis Pharmaceuticals, AbbVie, Bayer, Boston Scientific, CeleCor Therapeutics, Correvio, Espero BioPharma, Medscape, Medtronic, Merck, National Institutes of Health, Novo Nordisk, Rhoshan Pharmaceuticals, and Roche Diagnostics. Dr. Virani disclosed ties with the Department of Veterans Affairs, the National Institutes of Health, the World Heart Federation, and the Jooma and Tahir Family, and the American College of Cardiology.

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

The Sedentary Behavior Research Network has published new guidelines “to provide guidance to parents, educators, policy makers, researchers, and health care providers” on means to reduce school-related sedentary behavior.

The recommendations, published in the International Journal of Behavioral Nutrition and Physical Activity were written by researchers led by Travis J. Saunders, PhD, associate professor of applied human sciences at the University of Prince Edward Island, Charlottetown. Based on work carried out by a panel of international experts and informed by the best available evidence and stakeholder consultation, “these recommendations will be useful in supporting the physical and mental health, well-being, and academic success of school-age children and youth,” according to the authors.

The key strength of their work, they wrote, is that it is based on robust scientific data and specifically refers to school-related sedentary behaviors, whether these occur during lessons in the classroom or while completing assignments at home. “Existing sedentary behavior guidelines for children and youth target overall sedentary behavior and recreational screen time, without any specific recommendations regarding school-related sedentary behaviors.” The article also mentions the impact of the COVID-19 pandemic. Lack of movement was already a problem in these age groups; social distancing and distance learning over such an extended period only made things worse.
 

Risks and benefits

Dr. Saunders and colleagues wrote: “The relationships between sedentary behaviors and student health and academic outcomes are complex and likely differ for specific sedentary behaviors.”

While on one hand sedentary behavior may have a significant negative impact on metabolic outcomes, there is evidence that higher durations of homework and reading are associated with better academic achievement among school-aged children.

Another example of this complexity is that screen-based sedentary behaviors (spending time in front of computer screens, TVs, tablets, smartphones) often demonstrate deleterious associations with a range of health outcomes among school-aged children and youth aged 5-18 years, including body composition, cardiometabolic risk, and self-esteem. Yet screen-based devices may offer opportunities for novel pedagogic approaches and student engagement and may increase access to education for some students, especially during the COVID-19 pandemic.

The researchers noted that “many common sedentary activities ... do not have to be sedentary in nature. These behaviors are only considered to be sedentary when combined with both low energy expenditure and a sitting, reclining, or lying posture.” As an example, they pointed out that “active video gaming, or paper-based work at a standing desk, are both ways that common sedentary behaviors can be made nonsedentary.”

One thing’s for sure: Children and teenagers don’t move around all that much.

Data from the 2019 Eye on Health survey found that one of five children (20.3%) had not engaged in any physical activity the day before the survey, almost half (43.5%) had a TV in their bedroom, and about the same number (44.5%) spent more than 2 hours a day in front of a screen.

As for schools, the survey showed that, while 93% had initiatives to promote physical activity, fewer than 30% of these programs involved parents. It should be kept in mind that these are prepandemic numbers.
 

‘A healthy school day’

The authors recommend the following for reducing school-related sedentary behavior:

• Break up periods of extended sedentary behavior with both scheduled and unscheduled movement breaks: at least once every 30 minutes for ages 5-11 years and at least once every hour for ages 12-18 years. Consider activities that vary in intensity and duration (for example, standing, stretching breaks, moving to another classroom, active lessons, active breaks).
• Incorporate different types of movement into homework whenever possible, and limit sedentary homework to no more than 10 minutes per day per grade level (for example, no more than 10 minutes per day in grade 1, or 60 minutes per day in grade 6).
• Regardless of the location, school-related screen time should be meaningful, mentally or physically active, and serve a specific pedagogic purpose that enhances learning, compared with alternative methods. When school-related screen time is warranted, the following are recommended: limit time on devices, especially for students age 5-11 years; take a device break at least once every 30 minutes; discourage media multitasking in the classroom and while doing homework; and avoid screen-based homework within an hour of bedtime.
• Replace sedentary learning activities with movement-based learning activities (including standing) and replacing screen-based learning activities with non–screen-based learning activities (for example, outdoor lessons) can further support students’ health and well-being.

“Given the important role that schools can play in the promotion of healthy behaviors,” Dr. Saunders and associates wrote, “we encourage national and international public health agencies to consider inclusion of specific recommendations related to the school environment in future sedentary behavior guidelines.”

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

The Sedentary Behavior Research Network has published new guidelines “to provide guidance to parents, educators, policy makers, researchers, and health care providers” on means to reduce school-related sedentary behavior.

The recommendations, published in the International Journal of Behavioral Nutrition and Physical Activity were written by researchers led by Travis J. Saunders, PhD, associate professor of applied human sciences at the University of Prince Edward Island, Charlottetown. Based on work carried out by a panel of international experts and informed by the best available evidence and stakeholder consultation, “these recommendations will be useful in supporting the physical and mental health, well-being, and academic success of school-age children and youth,” according to the authors.

The key strength of their work, they wrote, is that it is based on robust scientific data and specifically refers to school-related sedentary behaviors, whether these occur during lessons in the classroom or while completing assignments at home. “Existing sedentary behavior guidelines for children and youth target overall sedentary behavior and recreational screen time, without any specific recommendations regarding school-related sedentary behaviors.” The article also mentions the impact of the COVID-19 pandemic. Lack of movement was already a problem in these age groups; social distancing and distance learning over such an extended period only made things worse.
 

Risks and benefits

Dr. Saunders and colleagues wrote: “The relationships between sedentary behaviors and student health and academic outcomes are complex and likely differ for specific sedentary behaviors.”

While on one hand sedentary behavior may have a significant negative impact on metabolic outcomes, there is evidence that higher durations of homework and reading are associated with better academic achievement among school-aged children.

Another example of this complexity is that screen-based sedentary behaviors (spending time in front of computer screens, TVs, tablets, smartphones) often demonstrate deleterious associations with a range of health outcomes among school-aged children and youth aged 5-18 years, including body composition, cardiometabolic risk, and self-esteem. Yet screen-based devices may offer opportunities for novel pedagogic approaches and student engagement and may increase access to education for some students, especially during the COVID-19 pandemic.

The researchers noted that “many common sedentary activities ... do not have to be sedentary in nature. These behaviors are only considered to be sedentary when combined with both low energy expenditure and a sitting, reclining, or lying posture.” As an example, they pointed out that “active video gaming, or paper-based work at a standing desk, are both ways that common sedentary behaviors can be made nonsedentary.”

One thing’s for sure: Children and teenagers don’t move around all that much.

Data from the 2019 Eye on Health survey found that one of five children (20.3%) had not engaged in any physical activity the day before the survey, almost half (43.5%) had a TV in their bedroom, and about the same number (44.5%) spent more than 2 hours a day in front of a screen.

As for schools, the survey showed that, while 93% had initiatives to promote physical activity, fewer than 30% of these programs involved parents. It should be kept in mind that these are prepandemic numbers.
 

‘A healthy school day’

The authors recommend the following for reducing school-related sedentary behavior:

• Break up periods of extended sedentary behavior with both scheduled and unscheduled movement breaks: at least once every 30 minutes for ages 5-11 years and at least once every hour for ages 12-18 years. Consider activities that vary in intensity and duration (for example, standing, stretching breaks, moving to another classroom, active lessons, active breaks).
• Incorporate different types of movement into homework whenever possible, and limit sedentary homework to no more than 10 minutes per day per grade level (for example, no more than 10 minutes per day in grade 1, or 60 minutes per day in grade 6).
• Regardless of the location, school-related screen time should be meaningful, mentally or physically active, and serve a specific pedagogic purpose that enhances learning, compared with alternative methods. When school-related screen time is warranted, the following are recommended: limit time on devices, especially for students age 5-11 years; take a device break at least once every 30 minutes; discourage media multitasking in the classroom and while doing homework; and avoid screen-based homework within an hour of bedtime.
• Replace sedentary learning activities with movement-based learning activities (including standing) and replacing screen-based learning activities with non–screen-based learning activities (for example, outdoor lessons) can further support students’ health and well-being.

“Given the important role that schools can play in the promotion of healthy behaviors,” Dr. Saunders and associates wrote, “we encourage national and international public health agencies to consider inclusion of specific recommendations related to the school environment in future sedentary behavior guidelines.”

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

The Sedentary Behavior Research Network has published new guidelines “to provide guidance to parents, educators, policy makers, researchers, and health care providers” on means to reduce school-related sedentary behavior.

The recommendations, published in the International Journal of Behavioral Nutrition and Physical Activity were written by researchers led by Travis J. Saunders, PhD, associate professor of applied human sciences at the University of Prince Edward Island, Charlottetown. Based on work carried out by a panel of international experts and informed by the best available evidence and stakeholder consultation, “these recommendations will be useful in supporting the physical and mental health, well-being, and academic success of school-age children and youth,” according to the authors.

The key strength of their work, they wrote, is that it is based on robust scientific data and specifically refers to school-related sedentary behaviors, whether these occur during lessons in the classroom or while completing assignments at home. “Existing sedentary behavior guidelines for children and youth target overall sedentary behavior and recreational screen time, without any specific recommendations regarding school-related sedentary behaviors.” The article also mentions the impact of the COVID-19 pandemic. Lack of movement was already a problem in these age groups; social distancing and distance learning over such an extended period only made things worse.
 

Risks and benefits

Dr. Saunders and colleagues wrote: “The relationships between sedentary behaviors and student health and academic outcomes are complex and likely differ for specific sedentary behaviors.”

While on one hand sedentary behavior may have a significant negative impact on metabolic outcomes, there is evidence that higher durations of homework and reading are associated with better academic achievement among school-aged children.

Another example of this complexity is that screen-based sedentary behaviors (spending time in front of computer screens, TVs, tablets, smartphones) often demonstrate deleterious associations with a range of health outcomes among school-aged children and youth aged 5-18 years, including body composition, cardiometabolic risk, and self-esteem. Yet screen-based devices may offer opportunities for novel pedagogic approaches and student engagement and may increase access to education for some students, especially during the COVID-19 pandemic.

The researchers noted that “many common sedentary activities ... do not have to be sedentary in nature. These behaviors are only considered to be sedentary when combined with both low energy expenditure and a sitting, reclining, or lying posture.” As an example, they pointed out that “active video gaming, or paper-based work at a standing desk, are both ways that common sedentary behaviors can be made nonsedentary.”

One thing’s for sure: Children and teenagers don’t move around all that much.

Data from the 2019 Eye on Health survey found that one of five children (20.3%) had not engaged in any physical activity the day before the survey, almost half (43.5%) had a TV in their bedroom, and about the same number (44.5%) spent more than 2 hours a day in front of a screen.

As for schools, the survey showed that, while 93% had initiatives to promote physical activity, fewer than 30% of these programs involved parents. It should be kept in mind that these are prepandemic numbers.
 

‘A healthy school day’

The authors recommend the following for reducing school-related sedentary behavior:

• Break up periods of extended sedentary behavior with both scheduled and unscheduled movement breaks: at least once every 30 minutes for ages 5-11 years and at least once every hour for ages 12-18 years. Consider activities that vary in intensity and duration (for example, standing, stretching breaks, moving to another classroom, active lessons, active breaks).
• Incorporate different types of movement into homework whenever possible, and limit sedentary homework to no more than 10 minutes per day per grade level (for example, no more than 10 minutes per day in grade 1, or 60 minutes per day in grade 6).
• Regardless of the location, school-related screen time should be meaningful, mentally or physically active, and serve a specific pedagogic purpose that enhances learning, compared with alternative methods. When school-related screen time is warranted, the following are recommended: limit time on devices, especially for students age 5-11 years; take a device break at least once every 30 minutes; discourage media multitasking in the classroom and while doing homework; and avoid screen-based homework within an hour of bedtime.
• Replace sedentary learning activities with movement-based learning activities (including standing) and replacing screen-based learning activities with non–screen-based learning activities (for example, outdoor lessons) can further support students’ health and well-being.

“Given the important role that schools can play in the promotion of healthy behaviors,” Dr. Saunders and associates wrote, “we encourage national and international public health agencies to consider inclusion of specific recommendations related to the school environment in future sedentary behavior guidelines.”

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

Mild traumatic brain injury (TBI) is linked to a significantly increased risk for a host of subsequent cardiovascular, endocrine, neurologic, and psychiatric disorders, new research shows.

Incidence of hypertension, coronary heart disease, diabetes, stroke, depression, and dementia all began to increase soon after the brain injury and persisted over a decade in both mild and moderate to severe TBI.

Researchers found the multisystem comorbidities in all age groups, including in patients as young as 18. They also found that patients who developed multiple postinjury problems had higher mortality during the decade-long follow-up.

The findings suggest patients with TBI may require longer follow-up and proactive screening for multisystem disease, regardless of age or injury severity.

“The fact that both patients with mild and moderate to severe injuries both had long-term ongoing associations with comorbidities that continued over time and that they are cardiovascular, endocrine, neurologic, and behavioral health oriented was pretty striking,” study author Ross Zafonte, DO, PhD, president of Spaulding Rehab Hospital and professor and chair of physical medicine and rehab at Harvard Medical School, both in Boston, told this news organization.

The study was published online in JAMA Network Open.
 

Injury severity not a factor

An estimated 2.8 million individuals in the United States experience TBI every year. Worldwide, the figure may be as high as 74 million.

Studies have long suggested a link between brain injury and subsequent neurologic disorders, but research suggesting a possible link to cardiovascular and endocrine problems has recently gained attention.

Building on a 2021 study that showed increased incidence of cardiovascular issues following a concussion, the researchers examined medical records of previously healthy patients treated for TBI between 2000 and 2015 who also had at least 1 follow-up visit between 6 months and 10 years after the initial injury.

Researchers analyzed data from 13,053 individuals – 4,351 with mild injury (mTBI), 4351 with moderate to severe injury (msTBI), and 4351 with no TBI. The most common cause of injury was a fall. Patients with sports-related injuries were excluded.

Incidence of hypertension was significantly higher among patients with mTBI (hazard ratio, 2.5; 95% confidence interval, 2.1-2.9) and msTBI (HR, 2.4; 95% CI, 2.0-2.9), compared with the unaffected group. Risk for other cardiovascular problems, including hyperlipidemia, obesity, and coronary artery disease, were also higher in the affected groups.

TBI patients also reported higher incidence of endocrine diseases, including diabetes (mTBI: HR, 1.9; 95% CI, 1.4-2.7; msTBI: HR, 1.9; 95% CI, 1.4-2.6). Elevated risk for ischemic stroke or transient ischemic attack was also increased (mTBI: HR, 2.2; 95% CI, 1.4-3.3; msTBI: HR, 3.6; 95% CI, 2.4-5.3).

Regardless of injury severity, patients with TBI had a higher risk for neurologic and psychiatric diseases, particularly depression, dementia, and psychotic disorders. “This tells us that mild TBI is not clean of events,” Dr. Zafonte said.

Surprising rate of comorbidity in youth

Investigators found increased risk for posttrauma comorbidities in all age groups, but researchers were struck by the high rates in younger patients, aged 18-40. Compared with age-matched individuals with no TBI history, hypertension risk was nearly six times higher in those with mTBI (HR, 5.9; 95% CI, 3.9-9.1) and nearly four times higher in patients with msTBI (HR, 3.9; 95% CI, 2.5-6.1).

Rates of hyperlipidemia and diabetes were also higher in younger patients in the mTBI group and posttraumatic seizures and psychiatric disorders were elevated regardless of TBI severity.

Overall, patients with msTBI, but not those with mTBI, were at higher risk for mortality, compared with the unexposed group (432 deaths [9.9%] vs. 250 deaths [5.7%]; P < .001).

“It’s clear that what we may be dealing with is that it holds up even for the younger people,” Dr. Zafonte said. “We used to think brain injury risk is worse in the severe cases, which it is, and it’s worse later on among those who are older, which it is. But our younger folks don’t get away either.”

While the study offers associations between TBI and multisystem health problems, Dr. Zafonte said it’s impossible to say at this point whether the brain injury caused the increased risk for cardiovascular or endocrine problems. Other organ injuries sustained in the trauma may be a contributing factor.

“Further data is needed to elucidate the mechanism and the causative relationships, which we do not have here,” he said.

Many of the postinjury comorbidities emerged a median of 3.5 years after TBI, regardless of severity. But some of the cardiovascular and psychiatric conditions emerged far sooner than that.

That’s important because research suggests less than half of patients with TBI receive follow-up care.

“It does make sense for folks who are interacting with people who’ve had a TBI to be suspicious of medical comorbidities relatively early on, within the first couple of years,” Dr. Zafonte said.

In an invited commentary, Vijay Krishnamoorthy, MD, MPH, PhD, Duke University, Durham, N.C., and Monica S. Vavilala, MD, University of Washington, Seattle, highlight some of the study’s limitations, including a lack of information on comorbidity severity and the lack of a matched group of patients who experienced non-head trauma.

Despite those limitations, the study offers important information on how TBI may affect organs beyond the brain, they noted.

“These observations, if replicated in future studies, raise intriguing implications in the future care of patients with TBI, including heightened chronic disease-screening measures and possibly enhanced guidelines for chronic extracranial organ system care for patients who experience TBI,” Dr. Krishnamoorthy and Dr. Vavilala wrote.

The study received no specific funding. Dr. Zafonte reported having received personal fees from Springer/Demos, serving on scientific advisory boards for Myomo and OnCare and has received funding from the Football Players Health Study at Harvard, funded in part by the National Football League Players Association. Dr. Krishnamoorthy and Dr. Vavilala disclosed no relevant financial relationships.

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

Mild traumatic brain injury (TBI) is linked to a significantly increased risk for a host of subsequent cardiovascular, endocrine, neurologic, and psychiatric disorders, new research shows.

Incidence of hypertension, coronary heart disease, diabetes, stroke, depression, and dementia all began to increase soon after the brain injury and persisted over a decade in both mild and moderate to severe TBI.

Researchers found the multisystem comorbidities in all age groups, including in patients as young as 18. They also found that patients who developed multiple postinjury problems had higher mortality during the decade-long follow-up.

The findings suggest patients with TBI may require longer follow-up and proactive screening for multisystem disease, regardless of age or injury severity.

“The fact that both patients with mild and moderate to severe injuries both had long-term ongoing associations with comorbidities that continued over time and that they are cardiovascular, endocrine, neurologic, and behavioral health oriented was pretty striking,” study author Ross Zafonte, DO, PhD, president of Spaulding Rehab Hospital and professor and chair of physical medicine and rehab at Harvard Medical School, both in Boston, told this news organization.

The study was published online in JAMA Network Open.
 

Injury severity not a factor

An estimated 2.8 million individuals in the United States experience TBI every year. Worldwide, the figure may be as high as 74 million.

Studies have long suggested a link between brain injury and subsequent neurologic disorders, but research suggesting a possible link to cardiovascular and endocrine problems has recently gained attention.

Building on a 2021 study that showed increased incidence of cardiovascular issues following a concussion, the researchers examined medical records of previously healthy patients treated for TBI between 2000 and 2015 who also had at least 1 follow-up visit between 6 months and 10 years after the initial injury.

Researchers analyzed data from 13,053 individuals – 4,351 with mild injury (mTBI), 4351 with moderate to severe injury (msTBI), and 4351 with no TBI. The most common cause of injury was a fall. Patients with sports-related injuries were excluded.

Incidence of hypertension was significantly higher among patients with mTBI (hazard ratio, 2.5; 95% confidence interval, 2.1-2.9) and msTBI (HR, 2.4; 95% CI, 2.0-2.9), compared with the unaffected group. Risk for other cardiovascular problems, including hyperlipidemia, obesity, and coronary artery disease, were also higher in the affected groups.

TBI patients also reported higher incidence of endocrine diseases, including diabetes (mTBI: HR, 1.9; 95% CI, 1.4-2.7; msTBI: HR, 1.9; 95% CI, 1.4-2.6). Elevated risk for ischemic stroke or transient ischemic attack was also increased (mTBI: HR, 2.2; 95% CI, 1.4-3.3; msTBI: HR, 3.6; 95% CI, 2.4-5.3).

Regardless of injury severity, patients with TBI had a higher risk for neurologic and psychiatric diseases, particularly depression, dementia, and psychotic disorders. “This tells us that mild TBI is not clean of events,” Dr. Zafonte said.

Surprising rate of comorbidity in youth

Investigators found increased risk for posttrauma comorbidities in all age groups, but researchers were struck by the high rates in younger patients, aged 18-40. Compared with age-matched individuals with no TBI history, hypertension risk was nearly six times higher in those with mTBI (HR, 5.9; 95% CI, 3.9-9.1) and nearly four times higher in patients with msTBI (HR, 3.9; 95% CI, 2.5-6.1).

Rates of hyperlipidemia and diabetes were also higher in younger patients in the mTBI group and posttraumatic seizures and psychiatric disorders were elevated regardless of TBI severity.

Overall, patients with msTBI, but not those with mTBI, were at higher risk for mortality, compared with the unexposed group (432 deaths [9.9%] vs. 250 deaths [5.7%]; P < .001).

“It’s clear that what we may be dealing with is that it holds up even for the younger people,” Dr. Zafonte said. “We used to think brain injury risk is worse in the severe cases, which it is, and it’s worse later on among those who are older, which it is. But our younger folks don’t get away either.”

While the study offers associations between TBI and multisystem health problems, Dr. Zafonte said it’s impossible to say at this point whether the brain injury caused the increased risk for cardiovascular or endocrine problems. Other organ injuries sustained in the trauma may be a contributing factor.

“Further data is needed to elucidate the mechanism and the causative relationships, which we do not have here,” he said.

Many of the postinjury comorbidities emerged a median of 3.5 years after TBI, regardless of severity. But some of the cardiovascular and psychiatric conditions emerged far sooner than that.

That’s important because research suggests less than half of patients with TBI receive follow-up care.

“It does make sense for folks who are interacting with people who’ve had a TBI to be suspicious of medical comorbidities relatively early on, within the first couple of years,” Dr. Zafonte said.

In an invited commentary, Vijay Krishnamoorthy, MD, MPH, PhD, Duke University, Durham, N.C., and Monica S. Vavilala, MD, University of Washington, Seattle, highlight some of the study’s limitations, including a lack of information on comorbidity severity and the lack of a matched group of patients who experienced non-head trauma.

Despite those limitations, the study offers important information on how TBI may affect organs beyond the brain, they noted.

“These observations, if replicated in future studies, raise intriguing implications in the future care of patients with TBI, including heightened chronic disease-screening measures and possibly enhanced guidelines for chronic extracranial organ system care for patients who experience TBI,” Dr. Krishnamoorthy and Dr. Vavilala wrote.

The study received no specific funding. Dr. Zafonte reported having received personal fees from Springer/Demos, serving on scientific advisory boards for Myomo and OnCare and has received funding from the Football Players Health Study at Harvard, funded in part by the National Football League Players Association. Dr. Krishnamoorthy and Dr. Vavilala disclosed no relevant financial relationships.

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

Mild traumatic brain injury (TBI) is linked to a significantly increased risk for a host of subsequent cardiovascular, endocrine, neurologic, and psychiatric disorders, new research shows.

Incidence of hypertension, coronary heart disease, diabetes, stroke, depression, and dementia all began to increase soon after the brain injury and persisted over a decade in both mild and moderate to severe TBI.

Researchers found the multisystem comorbidities in all age groups, including in patients as young as 18. They also found that patients who developed multiple postinjury problems had higher mortality during the decade-long follow-up.

The findings suggest patients with TBI may require longer follow-up and proactive screening for multisystem disease, regardless of age or injury severity.

“The fact that both patients with mild and moderate to severe injuries both had long-term ongoing associations with comorbidities that continued over time and that they are cardiovascular, endocrine, neurologic, and behavioral health oriented was pretty striking,” study author Ross Zafonte, DO, PhD, president of Spaulding Rehab Hospital and professor and chair of physical medicine and rehab at Harvard Medical School, both in Boston, told this news organization.

The study was published online in JAMA Network Open.
 

Injury severity not a factor

An estimated 2.8 million individuals in the United States experience TBI every year. Worldwide, the figure may be as high as 74 million.

Studies have long suggested a link between brain injury and subsequent neurologic disorders, but research suggesting a possible link to cardiovascular and endocrine problems has recently gained attention.

Building on a 2021 study that showed increased incidence of cardiovascular issues following a concussion, the researchers examined medical records of previously healthy patients treated for TBI between 2000 and 2015 who also had at least 1 follow-up visit between 6 months and 10 years after the initial injury.

Researchers analyzed data from 13,053 individuals – 4,351 with mild injury (mTBI), 4351 with moderate to severe injury (msTBI), and 4351 with no TBI. The most common cause of injury was a fall. Patients with sports-related injuries were excluded.

Incidence of hypertension was significantly higher among patients with mTBI (hazard ratio, 2.5; 95% confidence interval, 2.1-2.9) and msTBI (HR, 2.4; 95% CI, 2.0-2.9), compared with the unaffected group. Risk for other cardiovascular problems, including hyperlipidemia, obesity, and coronary artery disease, were also higher in the affected groups.

TBI patients also reported higher incidence of endocrine diseases, including diabetes (mTBI: HR, 1.9; 95% CI, 1.4-2.7; msTBI: HR, 1.9; 95% CI, 1.4-2.6). Elevated risk for ischemic stroke or transient ischemic attack was also increased (mTBI: HR, 2.2; 95% CI, 1.4-3.3; msTBI: HR, 3.6; 95% CI, 2.4-5.3).

Regardless of injury severity, patients with TBI had a higher risk for neurologic and psychiatric diseases, particularly depression, dementia, and psychotic disorders. “This tells us that mild TBI is not clean of events,” Dr. Zafonte said.

Surprising rate of comorbidity in youth

Investigators found increased risk for posttrauma comorbidities in all age groups, but researchers were struck by the high rates in younger patients, aged 18-40. Compared with age-matched individuals with no TBI history, hypertension risk was nearly six times higher in those with mTBI (HR, 5.9; 95% CI, 3.9-9.1) and nearly four times higher in patients with msTBI (HR, 3.9; 95% CI, 2.5-6.1).

Rates of hyperlipidemia and diabetes were also higher in younger patients in the mTBI group and posttraumatic seizures and psychiatric disorders were elevated regardless of TBI severity.

Overall, patients with msTBI, but not those with mTBI, were at higher risk for mortality, compared with the unexposed group (432 deaths [9.9%] vs. 250 deaths [5.7%]; P < .001).

“It’s clear that what we may be dealing with is that it holds up even for the younger people,” Dr. Zafonte said. “We used to think brain injury risk is worse in the severe cases, which it is, and it’s worse later on among those who are older, which it is. But our younger folks don’t get away either.”

While the study offers associations between TBI and multisystem health problems, Dr. Zafonte said it’s impossible to say at this point whether the brain injury caused the increased risk for cardiovascular or endocrine problems. Other organ injuries sustained in the trauma may be a contributing factor.

“Further data is needed to elucidate the mechanism and the causative relationships, which we do not have here,” he said.

Many of the postinjury comorbidities emerged a median of 3.5 years after TBI, regardless of severity. But some of the cardiovascular and psychiatric conditions emerged far sooner than that.

That’s important because research suggests less than half of patients with TBI receive follow-up care.

“It does make sense for folks who are interacting with people who’ve had a TBI to be suspicious of medical comorbidities relatively early on, within the first couple of years,” Dr. Zafonte said.

In an invited commentary, Vijay Krishnamoorthy, MD, MPH, PhD, Duke University, Durham, N.C., and Monica S. Vavilala, MD, University of Washington, Seattle, highlight some of the study’s limitations, including a lack of information on comorbidity severity and the lack of a matched group of patients who experienced non-head trauma.

Despite those limitations, the study offers important information on how TBI may affect organs beyond the brain, they noted.

“These observations, if replicated in future studies, raise intriguing implications in the future care of patients with TBI, including heightened chronic disease-screening measures and possibly enhanced guidelines for chronic extracranial organ system care for patients who experience TBI,” Dr. Krishnamoorthy and Dr. Vavilala wrote.

The study received no specific funding. Dr. Zafonte reported having received personal fees from Springer/Demos, serving on scientific advisory boards for Myomo and OnCare and has received funding from the Football Players Health Study at Harvard, funded in part by the National Football League Players Association. Dr. Krishnamoorthy and Dr. Vavilala disclosed no relevant financial relationships.

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

The Society for Cardiovascular Angiography and Interventions (SCAI) has issued the first statement on best practices for percutaneous axillary arterial access and training.

The position statement helps fill a gap amid increasing use of transaxillary access as an alternative to the femoral route for large-bore transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR), and mechanical circulatory support.

“The need for alternative access has increased as we are using more and more TAVR for our elderly population, and EVAR has also increased,” writing committee chair Arnold H. Seto, MD, Long Beach VA Health Care System (California) said in an interview. “There’s also a set of patients who require balloon pumps for a prolonged period, and people were using balloon pumps from the axillary approach, which were not custom-designed for that purpose.”

He noted that the evidence base leans heavily on case reports and case series, and that they were approached for guidance by a vendor developing a balloon pump specific to axillary access. “So that helped spur all of us to get together and decide to write up something on this topic, which was developing, but was certainly picking up steam rapidly.”

The statement was published in the Journal of the Society for Cardiovascular Angiography and Interventions, and it reflects the consensus of experts in heart failure, interventional cardiology and radiology, and cardiothoracic and vascular surgery. It reviews anatomic considerations and risks for percutaneous axillary access and suggests techniques for insertion, closure, and complication management.

Although the femoral artery is the most frequent access site for percutaneous large-bore procedures, the document notes that this approach may be limited in 13%-20% of patients because of prior surgeries or severe aortoiliac and/or iliofemoral atherosclerotic disease, tortuosity, or calcification.

“Absolutely, the femoral should be the predominant access site,” Dr. Seto said. Whenever there is a compromised femoral artery, “the axillary artery, which is rarely involved with atherosclerosis, makes for the most optimal alternative access. Other forms of alternative access, including transcaval and transcarotid, are possible but have their own issues and difficulties.”

Axillary access has traditionally been done through an open surgical approach, which allows for direct puncture, primary arterial repair, or placement of a sidearm conduit. Percutaneous transaxillary access avoids a surgical incision and general anesthesia and, theoretically, reduces the risk of infection, he said. It also allows for better mobility for patients, for example, who may have a balloon pump in place for weeks or even a month when waiting for a bridge to transplant.

In terms of technique, key recommendations include:

• Gaining access preferably through the left axillary
• Inserting the needle directly through the pectoralis minor into the second segment of the axillary artery
• Using a shallow-needle angle of 25-30 degrees to improve access success and decrease sheath malformation, kinking, bleeding, or vessel perforation
• Using micropuncture needles to minimize trauma to adjacent tissues
• Abducting the patient’s arm to 45-90 degrees to reduce tortuosity
• Using angiographic and ultrasound techniques to optimize vascular access

The latter point was the one area of debate among the writing committee, Dr. Seto observed. “That is one of the controversies: Should we make ultrasound mandatory? ... Everybody agreed that it can be quite useful and was likely to be useful because of its success in every other access area,” he said. “But in the absence of randomized evidence, we couldn’t make it mandatory or a strong recommendation. We just had to make it one of several options for the operator.”

The document highlights the need for familiarity with potential axillary artery complications and their management, noting that the axillary is more fragile than the femoral artery and, thus, potentially more prone to complications during instrumentation.

Data from the ARMS study in 102 patients undergoing transaxillary access for mechanical hemodynamic support reported 17 procedural complications, including 10 minor access site bleeding events, one stroke, and one pseudoaneurysm. A small study of 25 complex EVAR procedures reported a perioperative access complication rate of 8%, including one axillary artery dissection and one stenosis.

“Despite the brachial plexus being around there, there’s actually rare reports of neurologic injury and certainly none that have been permanent,” Dr. Seto said. “Also, stroke risk is probably more related to your device size and type of device rather than the approach itself.”

A significant amount of the paper is also devoted to training and privileging suggestions with an emphasis on a multidisciplinary team. The writing group recommends graduate medical education programs develop training curricula in percutaneous axillary artery access.

Those already in practice should participate in a formal training program that focuses on axillary artery anatomy, training in large bore access and closure devices, and didactic training in imaging modalities as applied to the axillary artery. Training can occur hands-on or using online simulations.

They also recommend outlining the potential need or role for proctoring and call for ongoing formal professional monitoring programs to evaluate operator outcomes using local or registry data.

“From a privileging standpoint, it was important for hospitals to be equally fair, regardless of the specialty that a requesting practitioner came from,” Dr. Seto said. “In other words, treat the vascular surgeons and interventional cardiologists and radiologists equally in terms of who has the privilege to do transaxillary access.”

The SCAI position statement has been endorsed by the American College of Cardiology, the Heart Failure Society of America, the Society of Interventional Radiology, and the Vascular & Endovascular Surgery Society.

Dr. Seto reported receiving honoraria from Getinge prior to initiation of the document. Disclosures for the rest of the writing group are available with the original article.

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

The Society for Cardiovascular Angiography and Interventions (SCAI) has issued the first statement on best practices for percutaneous axillary arterial access and training.

The position statement helps fill a gap amid increasing use of transaxillary access as an alternative to the femoral route for large-bore transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR), and mechanical circulatory support.

“The need for alternative access has increased as we are using more and more TAVR for our elderly population, and EVAR has also increased,” writing committee chair Arnold H. Seto, MD, Long Beach VA Health Care System (California) said in an interview. “There’s also a set of patients who require balloon pumps for a prolonged period, and people were using balloon pumps from the axillary approach, which were not custom-designed for that purpose.”

He noted that the evidence base leans heavily on case reports and case series, and that they were approached for guidance by a vendor developing a balloon pump specific to axillary access. “So that helped spur all of us to get together and decide to write up something on this topic, which was developing, but was certainly picking up steam rapidly.”

The statement was published in the Journal of the Society for Cardiovascular Angiography and Interventions, and it reflects the consensus of experts in heart failure, interventional cardiology and radiology, and cardiothoracic and vascular surgery. It reviews anatomic considerations and risks for percutaneous axillary access and suggests techniques for insertion, closure, and complication management.

Although the femoral artery is the most frequent access site for percutaneous large-bore procedures, the document notes that this approach may be limited in 13%-20% of patients because of prior surgeries or severe aortoiliac and/or iliofemoral atherosclerotic disease, tortuosity, or calcification.

“Absolutely, the femoral should be the predominant access site,” Dr. Seto said. Whenever there is a compromised femoral artery, “the axillary artery, which is rarely involved with atherosclerosis, makes for the most optimal alternative access. Other forms of alternative access, including transcaval and transcarotid, are possible but have their own issues and difficulties.”

Axillary access has traditionally been done through an open surgical approach, which allows for direct puncture, primary arterial repair, or placement of a sidearm conduit. Percutaneous transaxillary access avoids a surgical incision and general anesthesia and, theoretically, reduces the risk of infection, he said. It also allows for better mobility for patients, for example, who may have a balloon pump in place for weeks or even a month when waiting for a bridge to transplant.

In terms of technique, key recommendations include:

• Gaining access preferably through the left axillary
• Inserting the needle directly through the pectoralis minor into the second segment of the axillary artery
• Using a shallow-needle angle of 25-30 degrees to improve access success and decrease sheath malformation, kinking, bleeding, or vessel perforation
• Using micropuncture needles to minimize trauma to adjacent tissues
• Abducting the patient’s arm to 45-90 degrees to reduce tortuosity
• Using angiographic and ultrasound techniques to optimize vascular access

The latter point was the one area of debate among the writing committee, Dr. Seto observed. “That is one of the controversies: Should we make ultrasound mandatory? ... Everybody agreed that it can be quite useful and was likely to be useful because of its success in every other access area,” he said. “But in the absence of randomized evidence, we couldn’t make it mandatory or a strong recommendation. We just had to make it one of several options for the operator.”

The document highlights the need for familiarity with potential axillary artery complications and their management, noting that the axillary is more fragile than the femoral artery and, thus, potentially more prone to complications during instrumentation.

Data from the ARMS study in 102 patients undergoing transaxillary access for mechanical hemodynamic support reported 17 procedural complications, including 10 minor access site bleeding events, one stroke, and one pseudoaneurysm. A small study of 25 complex EVAR procedures reported a perioperative access complication rate of 8%, including one axillary artery dissection and one stenosis.

“Despite the brachial plexus being around there, there’s actually rare reports of neurologic injury and certainly none that have been permanent,” Dr. Seto said. “Also, stroke risk is probably more related to your device size and type of device rather than the approach itself.”

A significant amount of the paper is also devoted to training and privileging suggestions with an emphasis on a multidisciplinary team. The writing group recommends graduate medical education programs develop training curricula in percutaneous axillary artery access.

Those already in practice should participate in a formal training program that focuses on axillary artery anatomy, training in large bore access and closure devices, and didactic training in imaging modalities as applied to the axillary artery. Training can occur hands-on or using online simulations.

They also recommend outlining the potential need or role for proctoring and call for ongoing formal professional monitoring programs to evaluate operator outcomes using local or registry data.

“From a privileging standpoint, it was important for hospitals to be equally fair, regardless of the specialty that a requesting practitioner came from,” Dr. Seto said. “In other words, treat the vascular surgeons and interventional cardiologists and radiologists equally in terms of who has the privilege to do transaxillary access.”

The SCAI position statement has been endorsed by the American College of Cardiology, the Heart Failure Society of America, the Society of Interventional Radiology, and the Vascular & Endovascular Surgery Society.

Dr. Seto reported receiving honoraria from Getinge prior to initiation of the document. Disclosures for the rest of the writing group are available with the original article.

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

The Society for Cardiovascular Angiography and Interventions (SCAI) has issued the first statement on best practices for percutaneous axillary arterial access and training.

The position statement helps fill a gap amid increasing use of transaxillary access as an alternative to the femoral route for large-bore transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR), and mechanical circulatory support.

“The need for alternative access has increased as we are using more and more TAVR for our elderly population, and EVAR has also increased,” writing committee chair Arnold H. Seto, MD, Long Beach VA Health Care System (California) said in an interview. “There’s also a set of patients who require balloon pumps for a prolonged period, and people were using balloon pumps from the axillary approach, which were not custom-designed for that purpose.”

He noted that the evidence base leans heavily on case reports and case series, and that they were approached for guidance by a vendor developing a balloon pump specific to axillary access. “So that helped spur all of us to get together and decide to write up something on this topic, which was developing, but was certainly picking up steam rapidly.”

The statement was published in the Journal of the Society for Cardiovascular Angiography and Interventions, and it reflects the consensus of experts in heart failure, interventional cardiology and radiology, and cardiothoracic and vascular surgery. It reviews anatomic considerations and risks for percutaneous axillary access and suggests techniques for insertion, closure, and complication management.

Although the femoral artery is the most frequent access site for percutaneous large-bore procedures, the document notes that this approach may be limited in 13%-20% of patients because of prior surgeries or severe aortoiliac and/or iliofemoral atherosclerotic disease, tortuosity, or calcification.

“Absolutely, the femoral should be the predominant access site,” Dr. Seto said. Whenever there is a compromised femoral artery, “the axillary artery, which is rarely involved with atherosclerosis, makes for the most optimal alternative access. Other forms of alternative access, including transcaval and transcarotid, are possible but have their own issues and difficulties.”

Axillary access has traditionally been done through an open surgical approach, which allows for direct puncture, primary arterial repair, or placement of a sidearm conduit. Percutaneous transaxillary access avoids a surgical incision and general anesthesia and, theoretically, reduces the risk of infection, he said. It also allows for better mobility for patients, for example, who may have a balloon pump in place for weeks or even a month when waiting for a bridge to transplant.

In terms of technique, key recommendations include:

• Gaining access preferably through the left axillary
• Inserting the needle directly through the pectoralis minor into the second segment of the axillary artery
• Using a shallow-needle angle of 25-30 degrees to improve access success and decrease sheath malformation, kinking, bleeding, or vessel perforation
• Using micropuncture needles to minimize trauma to adjacent tissues
• Abducting the patient’s arm to 45-90 degrees to reduce tortuosity
• Using angiographic and ultrasound techniques to optimize vascular access

The latter point was the one area of debate among the writing committee, Dr. Seto observed. “That is one of the controversies: Should we make ultrasound mandatory? ... Everybody agreed that it can be quite useful and was likely to be useful because of its success in every other access area,” he said. “But in the absence of randomized evidence, we couldn’t make it mandatory or a strong recommendation. We just had to make it one of several options for the operator.”

The document highlights the need for familiarity with potential axillary artery complications and their management, noting that the axillary is more fragile than the femoral artery and, thus, potentially more prone to complications during instrumentation.

Data from the ARMS study in 102 patients undergoing transaxillary access for mechanical hemodynamic support reported 17 procedural complications, including 10 minor access site bleeding events, one stroke, and one pseudoaneurysm. A small study of 25 complex EVAR procedures reported a perioperative access complication rate of 8%, including one axillary artery dissection and one stenosis.

“Despite the brachial plexus being around there, there’s actually rare reports of neurologic injury and certainly none that have been permanent,” Dr. Seto said. “Also, stroke risk is probably more related to your device size and type of device rather than the approach itself.”

A significant amount of the paper is also devoted to training and privileging suggestions with an emphasis on a multidisciplinary team. The writing group recommends graduate medical education programs develop training curricula in percutaneous axillary artery access.

Those already in practice should participate in a formal training program that focuses on axillary artery anatomy, training in large bore access and closure devices, and didactic training in imaging modalities as applied to the axillary artery. Training can occur hands-on or using online simulations.

They also recommend outlining the potential need or role for proctoring and call for ongoing formal professional monitoring programs to evaluate operator outcomes using local or registry data.

“From a privileging standpoint, it was important for hospitals to be equally fair, regardless of the specialty that a requesting practitioner came from,” Dr. Seto said. “In other words, treat the vascular surgeons and interventional cardiologists and radiologists equally in terms of who has the privilege to do transaxillary access.”

The SCAI position statement has been endorsed by the American College of Cardiology, the Heart Failure Society of America, the Society of Interventional Radiology, and the Vascular & Endovascular Surgery Society.

Dr. Seto reported receiving honoraria from Getinge prior to initiation of the document. Disclosures for the rest of the writing group are available with the original article.

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

The U.S. Preventive Services Task Force has published a final recommendation statement on aspirin use to prevent cardiovascular disease.

The statement advises against starting aspirin for the primary prevention of cardiovascular disease in individuals aged 60 years or older.

For people aged 40-59 years, the USPSTF suggests that aspirin could be considered in those at increased risk of cardiovascular disease (10-year risk of 10% or greater) but that the decision should be individualized.

It notes that in the 40-59 age group, evidence indicates that the net benefit of aspirin use is small, and that persons who are not at increased risk for bleeding are more likely to benefit.

It adds that these recommendations apply only to people who do not have a history of cardiovascular disease and are not already taking daily aspirin.

The USPSTF statement was published online in the Journal of the American Medical Association. It is accompanied by an evidence review, a modeling study, a patient page, and an editorial.

A draft version of the recommendation statement, evidence review, and modeling report were previously available for public comment. The final recommendation statement is consistent with the draft version.

The task force concludes that there is adequate evidence that low-dose aspirin has a small benefit to reduce risk for cardiovascular events (nonfatal myocardial infarction and stroke) in adults 40 years or older who have no history of cardiovascular disease but are at increased cardiovascular risk.

Evidence shows that the absolute magnitude of benefit increases with increasing 10-year cardiovascular risk and that the magnitude of the lifetime benefits is greater when aspirin is initiated at a younger age.

But it adds that there is also adequate evidence that aspirin use in adults increases the risk for gastrointestinal bleeding, intracranial bleeding, and hemorrhagic stroke. The USPSTF determined that the magnitude of the harms is small overall but increases in older age groups, particularly in adults older than 60 years.

For patients who are eligible and choose to start taking aspirin, the benefits become smaller with advancing age, and data suggest that clinicians and patients should consider stopping aspirin use around age 75 years, the statement advises.

It also says that evidence is unclear whether aspirin use reduces the risk of colorectal cancer incidence or mortality.

USPSTF vice chair Michael Barry, MD, director of the Informed Medical Decisions Program in the Health Decision Sciences Center at Massachusetts General Hospital, Boston, told this news organization that these recommendations apply only to patients not taking aspirin already and who have no evidence of existing cardiovascular disease.

“In adults aged 60 or over we do not recommend starting aspirin for primary prevention. That is because in this age group the risk of bleeding outweighs the cardiovascular benefit,” he said.

“For adults aged 40-59 years with a greater than 10% predicted risk of cardiovascular disease, there appears to be a net benefit from taking aspirin, but this net benefit is relatively small and will vary with other factors such as magnitude of cardiovascular and bleeding risk. People should talk to their physician about these factors and whether to take aspirin or not,” he added.      

Dr. Barry noted that these recommendations do not apply to people who are already taking aspirin for primary prevention. “These people need to talk to their physicians about whether they should continue. They need to review the reasons why they started aspirin in the first place, and they need to have their bleeding risk evaluated. Someone who has taken aspirin long term without any bleeding complications has a lower risk of future bleeding complications,” he said.

The task force recommends an aspirin dose of 81 mg daily for those people deciding to take aspirin for primary prevention.    

“There is an abundance of evidence that less than 100 mg a day is enough. The lower the dose the lower the bleeding risk. So, the most convenient dose is the widely available 81-mg baby aspirin tablet,” Dr. Barry noted. “While enteric coated products are meant to reduce gastric irritation, the data do not show any difference in bleeding risk between various aspirin formulations,” he added.

Dr. Barry pointed out that aspirin is just one tool for reducing cardiovascular risk.

“People can reduce their risk significantly in many other ways including taking regular exercise, eating a healthy diet, controlling blood pressure and diabetes, and taking statins if they are at increased cardiovascular risk.”

He noted that recent trials have suggested that aspirin has only a marginal value over and above all these other factors. And the risk reduction with aspirin is smaller than with some other interventions.

“For example, aspirin is associated with a 12% reduction in MI whereas statins are associated with a 25%-30% reduction. Statins are a more powerful tool in reducing cardiovascular risk than aspirin, so perhaps people should consider taking statins first. The benefit of aspirin may be smaller in individuals already taking a statin, and clinicians need to think about the big picture,” Dr. Barry said.

He explained that physicians need to evaluate the cardiovascular and bleeding risk in each individual patient. “While there are widely available tools to estimate cardiovascular risk, there are no easy tools yet available to evaluate bleeding risk, so physicians need to consider clinical factors such as history of peptic ulcers.”

He suggests for the many people who have an average bleeding risk, then personal preference may come into play. “In the 40-59 age group, the benefits and harms of aspirin are pretty well-balanced. For the average person we think there may be a small net benefit, but this is small enough for personal preference to be considered as well.”
 

Pendulum swinging away from aspirin use

In an editorial accompanying publication of the task force statement in JAMA, Allan S. Brett, MD, clinical professor of internal medicine at the University of Colorado at Denver, Aurora, explains that the USPSTF recommendations on aspirin use for primary prevention of cardiovascular disease have changed numerous times over the past 30 years, with the last update in 2016 narrowing the eligible population.

In the new recommendation statement, “the pendulum has swung further away from aspirin prophylaxis for primary prevention: The guideline does not recommend routine preventive aspirin for anyone,” Dr. Brett notes.

He points out that an important development between the 2016 and current version was the publication in 2018 of three large placebo-controlled randomized clinical trials of primary prevention with aspirin – ARRIVE, ASPREE and ASCEND – which taken together “cast doubt about net benefit for aspirin prophylaxis in current practice.”

Asked how physicians should go about “individualizing” the decision on the use of aspirin in the 40-59 age group at increased cardiovascular risk, Dr. Brett suggests that some patents will have a general philosophy of medical care of “don’t prescribe medication for me unless there is strong evidence to support it,” while others may favor preventive interventions even in borderline cases.

But he notes that many patients have no strong general preferences and often ask a trusted clinician to decide for them. “For such patients, the best approach is for clinicians to be knowledgeable about the data on primary prevention with aspirin. Close reading of the new USPSTF guideline and its companion evidence review, and becoming familiar with the three more recent aspirin trials, is a good way to prepare for these clinical encounters,” he concludes.
 

A cardiologist’s view

Commenting on the task force statement for this news organization, Andrew Freeman, MD, a cardiologist at National Jewish Health, Denver, noted that cardiology societies are already making similar recommendations on aspirin use in primary prevention. “The American College of Cardiology prevention guidelines have been giving similar advice for a couple of years now. It takes a few years for professional societies to catch up with each other,” he said.

“Over the last few years, it has become obvious that the benefit of aspirin is not really very positive until a patient has had a cardiovascular event. In primary prevention, it doesn’t become beneficial unless they are at quite a high risk of having an event,” Dr. Freeman noted.

“In general, most cardiologists are now telling people that, despite what they may have been told in the past, they don’t need to be on aspirin unless they have had a cardiovascular event,” he added. “Our understanding has changed over the years and the weight of evidence has now become clear that the risk of bleeding is not insignificant.”

Dr. Freeman agreed with the shared decision-making advocated for patients in the 40-59 age group. “If a patient is particularly worried about a family history of heart disease, taking aspirin may make some sense, but for most people who have not had a cardiovascular event, the net benefit is very low and gets lower with age as the bleeding risk increases,” he said.  

The USPSTF is an independent, voluntary body. The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF.

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

The U.S. Preventive Services Task Force has published a final recommendation statement on aspirin use to prevent cardiovascular disease.

The statement advises against starting aspirin for the primary prevention of cardiovascular disease in individuals aged 60 years or older.

For people aged 40-59 years, the USPSTF suggests that aspirin could be considered in those at increased risk of cardiovascular disease (10-year risk of 10% or greater) but that the decision should be individualized.

It notes that in the 40-59 age group, evidence indicates that the net benefit of aspirin use is small, and that persons who are not at increased risk for bleeding are more likely to benefit.

It adds that these recommendations apply only to people who do not have a history of cardiovascular disease and are not already taking daily aspirin.

The USPSTF statement was published online in the Journal of the American Medical Association. It is accompanied by an evidence review, a modeling study, a patient page, and an editorial.

A draft version of the recommendation statement, evidence review, and modeling report were previously available for public comment. The final recommendation statement is consistent with the draft version.

The task force concludes that there is adequate evidence that low-dose aspirin has a small benefit to reduce risk for cardiovascular events (nonfatal myocardial infarction and stroke) in adults 40 years or older who have no history of cardiovascular disease but are at increased cardiovascular risk.

Evidence shows that the absolute magnitude of benefit increases with increasing 10-year cardiovascular risk and that the magnitude of the lifetime benefits is greater when aspirin is initiated at a younger age.

But it adds that there is also adequate evidence that aspirin use in adults increases the risk for gastrointestinal bleeding, intracranial bleeding, and hemorrhagic stroke. The USPSTF determined that the magnitude of the harms is small overall but increases in older age groups, particularly in adults older than 60 years.

For patients who are eligible and choose to start taking aspirin, the benefits become smaller with advancing age, and data suggest that clinicians and patients should consider stopping aspirin use around age 75 years, the statement advises.

It also says that evidence is unclear whether aspirin use reduces the risk of colorectal cancer incidence or mortality.

USPSTF vice chair Michael Barry, MD, director of the Informed Medical Decisions Program in the Health Decision Sciences Center at Massachusetts General Hospital, Boston, told this news organization that these recommendations apply only to patients not taking aspirin already and who have no evidence of existing cardiovascular disease.

“In adults aged 60 or over we do not recommend starting aspirin for primary prevention. That is because in this age group the risk of bleeding outweighs the cardiovascular benefit,” he said.

“For adults aged 40-59 years with a greater than 10% predicted risk of cardiovascular disease, there appears to be a net benefit from taking aspirin, but this net benefit is relatively small and will vary with other factors such as magnitude of cardiovascular and bleeding risk. People should talk to their physician about these factors and whether to take aspirin or not,” he added.      

Dr. Barry noted that these recommendations do not apply to people who are already taking aspirin for primary prevention. “These people need to talk to their physicians about whether they should continue. They need to review the reasons why they started aspirin in the first place, and they need to have their bleeding risk evaluated. Someone who has taken aspirin long term without any bleeding complications has a lower risk of future bleeding complications,” he said.

The task force recommends an aspirin dose of 81 mg daily for those people deciding to take aspirin for primary prevention.    

“There is an abundance of evidence that less than 100 mg a day is enough. The lower the dose the lower the bleeding risk. So, the most convenient dose is the widely available 81-mg baby aspirin tablet,” Dr. Barry noted. “While enteric coated products are meant to reduce gastric irritation, the data do not show any difference in bleeding risk between various aspirin formulations,” he added.

Dr. Barry pointed out that aspirin is just one tool for reducing cardiovascular risk.

“People can reduce their risk significantly in many other ways including taking regular exercise, eating a healthy diet, controlling blood pressure and diabetes, and taking statins if they are at increased cardiovascular risk.”

He noted that recent trials have suggested that aspirin has only a marginal value over and above all these other factors. And the risk reduction with aspirin is smaller than with some other interventions.

“For example, aspirin is associated with a 12% reduction in MI whereas statins are associated with a 25%-30% reduction. Statins are a more powerful tool in reducing cardiovascular risk than aspirin, so perhaps people should consider taking statins first. The benefit of aspirin may be smaller in individuals already taking a statin, and clinicians need to think about the big picture,” Dr. Barry said.

He explained that physicians need to evaluate the cardiovascular and bleeding risk in each individual patient. “While there are widely available tools to estimate cardiovascular risk, there are no easy tools yet available to evaluate bleeding risk, so physicians need to consider clinical factors such as history of peptic ulcers.”

He suggests for the many people who have an average bleeding risk, then personal preference may come into play. “In the 40-59 age group, the benefits and harms of aspirin are pretty well-balanced. For the average person we think there may be a small net benefit, but this is small enough for personal preference to be considered as well.”
 

Pendulum swinging away from aspirin use

In an editorial accompanying publication of the task force statement in JAMA, Allan S. Brett, MD, clinical professor of internal medicine at the University of Colorado at Denver, Aurora, explains that the USPSTF recommendations on aspirin use for primary prevention of cardiovascular disease have changed numerous times over the past 30 years, with the last update in 2016 narrowing the eligible population.

In the new recommendation statement, “the pendulum has swung further away from aspirin prophylaxis for primary prevention: The guideline does not recommend routine preventive aspirin for anyone,” Dr. Brett notes.

He points out that an important development between the 2016 and current version was the publication in 2018 of three large placebo-controlled randomized clinical trials of primary prevention with aspirin – ARRIVE, ASPREE and ASCEND – which taken together “cast doubt about net benefit for aspirin prophylaxis in current practice.”

Asked how physicians should go about “individualizing” the decision on the use of aspirin in the 40-59 age group at increased cardiovascular risk, Dr. Brett suggests that some patents will have a general philosophy of medical care of “don’t prescribe medication for me unless there is strong evidence to support it,” while others may favor preventive interventions even in borderline cases.

But he notes that many patients have no strong general preferences and often ask a trusted clinician to decide for them. “For such patients, the best approach is for clinicians to be knowledgeable about the data on primary prevention with aspirin. Close reading of the new USPSTF guideline and its companion evidence review, and becoming familiar with the three more recent aspirin trials, is a good way to prepare for these clinical encounters,” he concludes.
 

A cardiologist’s view

Commenting on the task force statement for this news organization, Andrew Freeman, MD, a cardiologist at National Jewish Health, Denver, noted that cardiology societies are already making similar recommendations on aspirin use in primary prevention. “The American College of Cardiology prevention guidelines have been giving similar advice for a couple of years now. It takes a few years for professional societies to catch up with each other,” he said.

“Over the last few years, it has become obvious that the benefit of aspirin is not really very positive until a patient has had a cardiovascular event. In primary prevention, it doesn’t become beneficial unless they are at quite a high risk of having an event,” Dr. Freeman noted.

“In general, most cardiologists are now telling people that, despite what they may have been told in the past, they don’t need to be on aspirin unless they have had a cardiovascular event,” he added. “Our understanding has changed over the years and the weight of evidence has now become clear that the risk of bleeding is not insignificant.”

Dr. Freeman agreed with the shared decision-making advocated for patients in the 40-59 age group. “If a patient is particularly worried about a family history of heart disease, taking aspirin may make some sense, but for most people who have not had a cardiovascular event, the net benefit is very low and gets lower with age as the bleeding risk increases,” he said.  

The USPSTF is an independent, voluntary body. The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF.

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

The U.S. Preventive Services Task Force has published a final recommendation statement on aspirin use to prevent cardiovascular disease.

The statement advises against starting aspirin for the primary prevention of cardiovascular disease in individuals aged 60 years or older.

For people aged 40-59 years, the USPSTF suggests that aspirin could be considered in those at increased risk of cardiovascular disease (10-year risk of 10% or greater) but that the decision should be individualized.

It notes that in the 40-59 age group, evidence indicates that the net benefit of aspirin use is small, and that persons who are not at increased risk for bleeding are more likely to benefit.

It adds that these recommendations apply only to people who do not have a history of cardiovascular disease and are not already taking daily aspirin.

The USPSTF statement was published online in the Journal of the American Medical Association. It is accompanied by an evidence review, a modeling study, a patient page, and an editorial.

A draft version of the recommendation statement, evidence review, and modeling report were previously available for public comment. The final recommendation statement is consistent with the draft version.

The task force concludes that there is adequate evidence that low-dose aspirin has a small benefit to reduce risk for cardiovascular events (nonfatal myocardial infarction and stroke) in adults 40 years or older who have no history of cardiovascular disease but are at increased cardiovascular risk.

Evidence shows that the absolute magnitude of benefit increases with increasing 10-year cardiovascular risk and that the magnitude of the lifetime benefits is greater when aspirin is initiated at a younger age.

But it adds that there is also adequate evidence that aspirin use in adults increases the risk for gastrointestinal bleeding, intracranial bleeding, and hemorrhagic stroke. The USPSTF determined that the magnitude of the harms is small overall but increases in older age groups, particularly in adults older than 60 years.

For patients who are eligible and choose to start taking aspirin, the benefits become smaller with advancing age, and data suggest that clinicians and patients should consider stopping aspirin use around age 75 years, the statement advises.

It also says that evidence is unclear whether aspirin use reduces the risk of colorectal cancer incidence or mortality.

USPSTF vice chair Michael Barry, MD, director of the Informed Medical Decisions Program in the Health Decision Sciences Center at Massachusetts General Hospital, Boston, told this news organization that these recommendations apply only to patients not taking aspirin already and who have no evidence of existing cardiovascular disease.

“In adults aged 60 or over we do not recommend starting aspirin for primary prevention. That is because in this age group the risk of bleeding outweighs the cardiovascular benefit,” he said.

“For adults aged 40-59 years with a greater than 10% predicted risk of cardiovascular disease, there appears to be a net benefit from taking aspirin, but this net benefit is relatively small and will vary with other factors such as magnitude of cardiovascular and bleeding risk. People should talk to their physician about these factors and whether to take aspirin or not,” he added.      

Dr. Barry noted that these recommendations do not apply to people who are already taking aspirin for primary prevention. “These people need to talk to their physicians about whether they should continue. They need to review the reasons why they started aspirin in the first place, and they need to have their bleeding risk evaluated. Someone who has taken aspirin long term without any bleeding complications has a lower risk of future bleeding complications,” he said.

The task force recommends an aspirin dose of 81 mg daily for those people deciding to take aspirin for primary prevention.    

“There is an abundance of evidence that less than 100 mg a day is enough. The lower the dose the lower the bleeding risk. So, the most convenient dose is the widely available 81-mg baby aspirin tablet,” Dr. Barry noted. “While enteric coated products are meant to reduce gastric irritation, the data do not show any difference in bleeding risk between various aspirin formulations,” he added.

Dr. Barry pointed out that aspirin is just one tool for reducing cardiovascular risk.

“People can reduce their risk significantly in many other ways including taking regular exercise, eating a healthy diet, controlling blood pressure and diabetes, and taking statins if they are at increased cardiovascular risk.”

He noted that recent trials have suggested that aspirin has only a marginal value over and above all these other factors. And the risk reduction with aspirin is smaller than with some other interventions.

“For example, aspirin is associated with a 12% reduction in MI whereas statins are associated with a 25%-30% reduction. Statins are a more powerful tool in reducing cardiovascular risk than aspirin, so perhaps people should consider taking statins first. The benefit of aspirin may be smaller in individuals already taking a statin, and clinicians need to think about the big picture,” Dr. Barry said.

He explained that physicians need to evaluate the cardiovascular and bleeding risk in each individual patient. “While there are widely available tools to estimate cardiovascular risk, there are no easy tools yet available to evaluate bleeding risk, so physicians need to consider clinical factors such as history of peptic ulcers.”

He suggests for the many people who have an average bleeding risk, then personal preference may come into play. “In the 40-59 age group, the benefits and harms of aspirin are pretty well-balanced. For the average person we think there may be a small net benefit, but this is small enough for personal preference to be considered as well.”
 

Pendulum swinging away from aspirin use

In an editorial accompanying publication of the task force statement in JAMA, Allan S. Brett, MD, clinical professor of internal medicine at the University of Colorado at Denver, Aurora, explains that the USPSTF recommendations on aspirin use for primary prevention of cardiovascular disease have changed numerous times over the past 30 years, with the last update in 2016 narrowing the eligible population.

In the new recommendation statement, “the pendulum has swung further away from aspirin prophylaxis for primary prevention: The guideline does not recommend routine preventive aspirin for anyone,” Dr. Brett notes.

He points out that an important development between the 2016 and current version was the publication in 2018 of three large placebo-controlled randomized clinical trials of primary prevention with aspirin – ARRIVE, ASPREE and ASCEND – which taken together “cast doubt about net benefit for aspirin prophylaxis in current practice.”

Asked how physicians should go about “individualizing” the decision on the use of aspirin in the 40-59 age group at increased cardiovascular risk, Dr. Brett suggests that some patents will have a general philosophy of medical care of “don’t prescribe medication for me unless there is strong evidence to support it,” while others may favor preventive interventions even in borderline cases.

But he notes that many patients have no strong general preferences and often ask a trusted clinician to decide for them. “For such patients, the best approach is for clinicians to be knowledgeable about the data on primary prevention with aspirin. Close reading of the new USPSTF guideline and its companion evidence review, and becoming familiar with the three more recent aspirin trials, is a good way to prepare for these clinical encounters,” he concludes.
 

A cardiologist’s view

Commenting on the task force statement for this news organization, Andrew Freeman, MD, a cardiologist at National Jewish Health, Denver, noted that cardiology societies are already making similar recommendations on aspirin use in primary prevention. “The American College of Cardiology prevention guidelines have been giving similar advice for a couple of years now. It takes a few years for professional societies to catch up with each other,” he said.

“Over the last few years, it has become obvious that the benefit of aspirin is not really very positive until a patient has had a cardiovascular event. In primary prevention, it doesn’t become beneficial unless they are at quite a high risk of having an event,” Dr. Freeman noted.

“In general, most cardiologists are now telling people that, despite what they may have been told in the past, they don’t need to be on aspirin unless they have had a cardiovascular event,” he added. “Our understanding has changed over the years and the weight of evidence has now become clear that the risk of bleeding is not insignificant.”

Dr. Freeman agreed with the shared decision-making advocated for patients in the 40-59 age group. “If a patient is particularly worried about a family history of heart disease, taking aspirin may make some sense, but for most people who have not had a cardiovascular event, the net benefit is very low and gets lower with age as the bleeding risk increases,” he said.  

The USPSTF is an independent, voluntary body. The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF.

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