Cardiology

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.

For the past 2 decades, catheter ablation stole most of the excitement in electrophysiology. Cardiac pacing was seen as necessary but boring. His-bundle pacing earned only modest attention. 

But at the annual scientific sessions of the Heart Rhythm Society, cardiac pacing consolidated its comeback and entered the super-cool category.

Not one but three late-breaking clinical trials considered the role of pacing the heart’s conduction system for both preventive and therapeutic purposes. Conduction system pacing, or CSP as we call it, includes pacing the His bundle or the left bundle branch. Left bundle–branch pacing has now largely replaced His-bundle pacing.

Before I tell you about the studies, let’s review why CSP disrupts the status quo.

The core idea goes back to basic physiology: After the impulse leaves the atrioventricular node, the heart’s specialized conduction system allows rapid and synchronous conduction to both the right and left ventricles.

Standard cardiac pacing means fixing a pacing lead into the muscle of the right ventricle. From that spot, conduction spreads via slower muscle-to-muscle conduction, which leads to a wide QRS complex and the right ventricle contracts before the left ventricle.

While such dyssynchronous contraction is better than no contraction, this approach leads to a pacing-induced cardiomyopathy in a substantial number of cases. (The incidence reported in many studies varies widely.)

The most disruptive effect of conduction system pacing is that it is a form of cardiac resynchronization therapy (CRT). And that is nifty because, until recently, resynchronizing the ventricles required placing two ventricular leads: one in the right ventricle and the other in the coronary sinus to pace the left ventricle.
 

Left bundle-branch pacing vs. biventricular pacing

The first of the three HRS studies is the LBBP-RESYNC randomized controlled trial led by Jiangang Zou, MD, PhD, and performed in multiple centers in China. It compared the efficacy of left bundle–branch pacing (LBBP) with that of conventional biventricular pacing in 40 patients with heart failure who were eligible for CRT. The primary endpoint was the change in left ventricular ejection fraction (LVEF) from baseline to 6-month follow-up.

The results favored LBBP. Although both pacing techniques improved LVEF from baseline, the between-group difference in LVEF was greater in the LBBP arm than the biventricular pacing arm by a statistically significant 5.6% (95% confidence interval, 0.3%-10.9%). Secondary endpoints, such as reductions in left ventricular end-systolic volume, N-terminal of the prohormone brain natriuretic peptide, and QRS duration, also favored LBBP.
 

Conduction system pacing vs. biventricular pacing

A second late-breaking study, from the Geisinger group, led by Pugazhendhi Vijayaraman, MD, was simultaneously published in Heart Rhythm.

This nonrandomized observational study compared nearly 500 patients eligible for CRT treated at two health systems. One group favors conduction system pacing and the other does traditional biventricular pacing, which set up a two-armed comparison.

CSP was accomplished by LBBP (65%) and His-bundle pacing (35%).

The primary endpoint of death or first hospitalization for heart failure occurred in 28.3% of patients in the CSP arm versus 38.4% of the biventricular arm (hazard ratio, 1.52; 95% CI, 1.08-2.09). QRS duration and LVEF also improved from baseline in both groups.
 

LBB area pacing as a bailout for failed CRT

The Geisinger group also presented and published an international multicenter study that assessed the feasibility of LBBP as a bailout when standard biventricular pacing did not work – because of inadequate coronary sinus anatomy or CRT nonresponse, defined as lack of clinical or echocardiographic improvement.

This series included 212 patients in whom CRT failed and who underwent attempted LBBP pacing. The bailout was successful in 200 patients (91%). The primary endpoint was defined as an increase in LVEF above 5% on echocardiography.

During 12-month follow-up, 61% of patients had an improvement in LVEF above 5% and nearly 30% had a “super-response,” defined as a 20% or greater increase or normalization of LVEF. Similar to the previous studies, LBBP resulted in shorter QRS duration and improved echocardiography parameters.
 

Am I persuaded?

I was an early adopter of His-bundle pacing. When successful, it delivered both aesthetically pleasing QRS complexes and clinical efficacy. But there were many challenges: it is technically difficult, and capture thresholds are often high at implant and get higher over time, which leads to shorter battery life.

Pacing the left bundle branch mitigates these challenges. Here, the operator approaches from the right side and screws the lead a few millimeters into the septum, so the tip of the lead can capture the left bundle or one of its branches. This allows activation of the heart’s specialized conduction system and thus synchronizes right and left ventricle contraction.

Although there is a learning curve, LBBP is technically easier than His-bundle pacing and ultimately results in far better pacing and sensing parameters. What’s more, the preferred lead for LBBP has a stellar efficacy record – over years.

Chormail/Dreamstime.com

The barriers to getting more CSP trials

The challenge going forward will be funding new trials. CSP stands to prevent pacing-induced cardiomyopathy and offer less costly alternatives to standard biventricular pacing for CRT. This is great for patients, but it would mean that fewer higher-cost CRT devices will be sold.

Heart rhythm research is largely industry-funded because in most cases better therapies for patients mean more profits for industry. In the case of CSP, there is no such confluence of interests.

Conduction system pacing has come about because of the efforts of a few tireless champions who not only published extensively but were also skilled at using social media to spread the excitement. Trials have been small and often self-funded.

The data presented at HRS provides enough equipoise to support a large outcomes-based randomized controlled trial. Imagine if our CSP champions were able to find public-funding sources for such future trials.

Now that would be super cool.

Dr. Mandrola practices cardiac electrophysiology in Louisville, Ky., and is a writer and podcaster for Medscape. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

For the past 2 decades, catheter ablation stole most of the excitement in electrophysiology. Cardiac pacing was seen as necessary but boring. His-bundle pacing earned only modest attention. 

But at the annual scientific sessions of the Heart Rhythm Society, cardiac pacing consolidated its comeback and entered the super-cool category.

Not one but three late-breaking clinical trials considered the role of pacing the heart’s conduction system for both preventive and therapeutic purposes. Conduction system pacing, or CSP as we call it, includes pacing the His bundle or the left bundle branch. Left bundle–branch pacing has now largely replaced His-bundle pacing.

Before I tell you about the studies, let’s review why CSP disrupts the status quo.

The core idea goes back to basic physiology: After the impulse leaves the atrioventricular node, the heart’s specialized conduction system allows rapid and synchronous conduction to both the right and left ventricles.

Standard cardiac pacing means fixing a pacing lead into the muscle of the right ventricle. From that spot, conduction spreads via slower muscle-to-muscle conduction, which leads to a wide QRS complex and the right ventricle contracts before the left ventricle.

While such dyssynchronous contraction is better than no contraction, this approach leads to a pacing-induced cardiomyopathy in a substantial number of cases. (The incidence reported in many studies varies widely.)

The most disruptive effect of conduction system pacing is that it is a form of cardiac resynchronization therapy (CRT). And that is nifty because, until recently, resynchronizing the ventricles required placing two ventricular leads: one in the right ventricle and the other in the coronary sinus to pace the left ventricle.
 

Left bundle-branch pacing vs. biventricular pacing

The first of the three HRS studies is the LBBP-RESYNC randomized controlled trial led by Jiangang Zou, MD, PhD, and performed in multiple centers in China. It compared the efficacy of left bundle–branch pacing (LBBP) with that of conventional biventricular pacing in 40 patients with heart failure who were eligible for CRT. The primary endpoint was the change in left ventricular ejection fraction (LVEF) from baseline to 6-month follow-up.

The results favored LBBP. Although both pacing techniques improved LVEF from baseline, the between-group difference in LVEF was greater in the LBBP arm than the biventricular pacing arm by a statistically significant 5.6% (95% confidence interval, 0.3%-10.9%). Secondary endpoints, such as reductions in left ventricular end-systolic volume, N-terminal of the prohormone brain natriuretic peptide, and QRS duration, also favored LBBP.
 

Conduction system pacing vs. biventricular pacing

A second late-breaking study, from the Geisinger group, led by Pugazhendhi Vijayaraman, MD, was simultaneously published in Heart Rhythm.

This nonrandomized observational study compared nearly 500 patients eligible for CRT treated at two health systems. One group favors conduction system pacing and the other does traditional biventricular pacing, which set up a two-armed comparison.

CSP was accomplished by LBBP (65%) and His-bundle pacing (35%).

The primary endpoint of death or first hospitalization for heart failure occurred in 28.3% of patients in the CSP arm versus 38.4% of the biventricular arm (hazard ratio, 1.52; 95% CI, 1.08-2.09). QRS duration and LVEF also improved from baseline in both groups.
 

LBB area pacing as a bailout for failed CRT

The Geisinger group also presented and published an international multicenter study that assessed the feasibility of LBBP as a bailout when standard biventricular pacing did not work – because of inadequate coronary sinus anatomy or CRT nonresponse, defined as lack of clinical or echocardiographic improvement.

This series included 212 patients in whom CRT failed and who underwent attempted LBBP pacing. The bailout was successful in 200 patients (91%). The primary endpoint was defined as an increase in LVEF above 5% on echocardiography.

During 12-month follow-up, 61% of patients had an improvement in LVEF above 5% and nearly 30% had a “super-response,” defined as a 20% or greater increase or normalization of LVEF. Similar to the previous studies, LBBP resulted in shorter QRS duration and improved echocardiography parameters.
 

Am I persuaded?

I was an early adopter of His-bundle pacing. When successful, it delivered both aesthetically pleasing QRS complexes and clinical efficacy. But there were many challenges: it is technically difficult, and capture thresholds are often high at implant and get higher over time, which leads to shorter battery life.

Pacing the left bundle branch mitigates these challenges. Here, the operator approaches from the right side and screws the lead a few millimeters into the septum, so the tip of the lead can capture the left bundle or one of its branches. This allows activation of the heart’s specialized conduction system and thus synchronizes right and left ventricle contraction.

Although there is a learning curve, LBBP is technically easier than His-bundle pacing and ultimately results in far better pacing and sensing parameters. What’s more, the preferred lead for LBBP has a stellar efficacy record – over years.

Chormail/Dreamstime.com

The barriers to getting more CSP trials

The challenge going forward will be funding new trials. CSP stands to prevent pacing-induced cardiomyopathy and offer less costly alternatives to standard biventricular pacing for CRT. This is great for patients, but it would mean that fewer higher-cost CRT devices will be sold.

Heart rhythm research is largely industry-funded because in most cases better therapies for patients mean more profits for industry. In the case of CSP, there is no such confluence of interests.

Conduction system pacing has come about because of the efforts of a few tireless champions who not only published extensively but were also skilled at using social media to spread the excitement. Trials have been small and often self-funded.

The data presented at HRS provides enough equipoise to support a large outcomes-based randomized controlled trial. Imagine if our CSP champions were able to find public-funding sources for such future trials.

Now that would be super cool.

Dr. Mandrola practices cardiac electrophysiology in Louisville, Ky., and is a writer and podcaster for Medscape. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

For the past 2 decades, catheter ablation stole most of the excitement in electrophysiology. Cardiac pacing was seen as necessary but boring. His-bundle pacing earned only modest attention. 

But at the annual scientific sessions of the Heart Rhythm Society, cardiac pacing consolidated its comeback and entered the super-cool category.

Not one but three late-breaking clinical trials considered the role of pacing the heart’s conduction system for both preventive and therapeutic purposes. Conduction system pacing, or CSP as we call it, includes pacing the His bundle or the left bundle branch. Left bundle–branch pacing has now largely replaced His-bundle pacing.

Before I tell you about the studies, let’s review why CSP disrupts the status quo.

The core idea goes back to basic physiology: After the impulse leaves the atrioventricular node, the heart’s specialized conduction system allows rapid and synchronous conduction to both the right and left ventricles.

Standard cardiac pacing means fixing a pacing lead into the muscle of the right ventricle. From that spot, conduction spreads via slower muscle-to-muscle conduction, which leads to a wide QRS complex and the right ventricle contracts before the left ventricle.

While such dyssynchronous contraction is better than no contraction, this approach leads to a pacing-induced cardiomyopathy in a substantial number of cases. (The incidence reported in many studies varies widely.)

The most disruptive effect of conduction system pacing is that it is a form of cardiac resynchronization therapy (CRT). And that is nifty because, until recently, resynchronizing the ventricles required placing two ventricular leads: one in the right ventricle and the other in the coronary sinus to pace the left ventricle.
 

Left bundle-branch pacing vs. biventricular pacing

The first of the three HRS studies is the LBBP-RESYNC randomized controlled trial led by Jiangang Zou, MD, PhD, and performed in multiple centers in China. It compared the efficacy of left bundle–branch pacing (LBBP) with that of conventional biventricular pacing in 40 patients with heart failure who were eligible for CRT. The primary endpoint was the change in left ventricular ejection fraction (LVEF) from baseline to 6-month follow-up.

The results favored LBBP. Although both pacing techniques improved LVEF from baseline, the between-group difference in LVEF was greater in the LBBP arm than the biventricular pacing arm by a statistically significant 5.6% (95% confidence interval, 0.3%-10.9%). Secondary endpoints, such as reductions in left ventricular end-systolic volume, N-terminal of the prohormone brain natriuretic peptide, and QRS duration, also favored LBBP.
 

Conduction system pacing vs. biventricular pacing

A second late-breaking study, from the Geisinger group, led by Pugazhendhi Vijayaraman, MD, was simultaneously published in Heart Rhythm.

This nonrandomized observational study compared nearly 500 patients eligible for CRT treated at two health systems. One group favors conduction system pacing and the other does traditional biventricular pacing, which set up a two-armed comparison.

CSP was accomplished by LBBP (65%) and His-bundle pacing (35%).

The primary endpoint of death or first hospitalization for heart failure occurred in 28.3% of patients in the CSP arm versus 38.4% of the biventricular arm (hazard ratio, 1.52; 95% CI, 1.08-2.09). QRS duration and LVEF also improved from baseline in both groups.
 

LBB area pacing as a bailout for failed CRT

The Geisinger group also presented and published an international multicenter study that assessed the feasibility of LBBP as a bailout when standard biventricular pacing did not work – because of inadequate coronary sinus anatomy or CRT nonresponse, defined as lack of clinical or echocardiographic improvement.

This series included 212 patients in whom CRT failed and who underwent attempted LBBP pacing. The bailout was successful in 200 patients (91%). The primary endpoint was defined as an increase in LVEF above 5% on echocardiography.

During 12-month follow-up, 61% of patients had an improvement in LVEF above 5% and nearly 30% had a “super-response,” defined as a 20% or greater increase or normalization of LVEF. Similar to the previous studies, LBBP resulted in shorter QRS duration and improved echocardiography parameters.
 

Am I persuaded?

I was an early adopter of His-bundle pacing. When successful, it delivered both aesthetically pleasing QRS complexes and clinical efficacy. But there were many challenges: it is technically difficult, and capture thresholds are often high at implant and get higher over time, which leads to shorter battery life.

Pacing the left bundle branch mitigates these challenges. Here, the operator approaches from the right side and screws the lead a few millimeters into the septum, so the tip of the lead can capture the left bundle or one of its branches. This allows activation of the heart’s specialized conduction system and thus synchronizes right and left ventricle contraction.

Although there is a learning curve, LBBP is technically easier than His-bundle pacing and ultimately results in far better pacing and sensing parameters. What’s more, the preferred lead for LBBP has a stellar efficacy record – over years.

Chormail/Dreamstime.com

The barriers to getting more CSP trials

The challenge going forward will be funding new trials. CSP stands to prevent pacing-induced cardiomyopathy and offer less costly alternatives to standard biventricular pacing for CRT. This is great for patients, but it would mean that fewer higher-cost CRT devices will be sold.

Heart rhythm research is largely industry-funded because in most cases better therapies for patients mean more profits for industry. In the case of CSP, there is no such confluence of interests.

Conduction system pacing has come about because of the efforts of a few tireless champions who not only published extensively but were also skilled at using social media to spread the excitement. Trials have been small and often self-funded.

The data presented at HRS provides enough equipoise to support a large outcomes-based randomized controlled trial. Imagine if our CSP champions were able to find public-funding sources for such future trials.

Now that would be super cool.

Dr. Mandrola practices cardiac electrophysiology in Louisville, Ky., and is a writer and podcaster for Medscape. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

Heart failure (HF) is a costly and burdensome illness and is the top reason for hospital admissions for the US Department of Veterans Affairs (VA) and Medicare.¹ The cost of HF to the United States is estimated to grow to $3 billion annually by 2030.² People living with HF have a high symptom burden and poor quality of life.^3,4 Symptoms include shortness of breath, fatigue, depression, and decreases in psychosocial, existential, and spiritual well-being.^5-9

Veterans in the US are a unique cultural group with distinct contextual considerations around their experiences.¹⁰ Different groups of veterans require unique cultural considerations, such as the experiences of veterans who served during the Vietnam war and during Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF). The extent of unmet needs of people living with HF, the number of veterans living with this illness, and the unique contextual components related to living with HF among veterans require further exploration into this illness experience for this distinct population. Research should explore innovative ways of managing both the number of people living with the illness and the significant impact of HF in people’s lives due to the high symptom burden and poor quality of life.³

This study used the model of adjustment to illness to explore the psychosocial adjustment to illness and the experience of US veterans living with HF, with a focus on the domains of meaning creation, self-schema, and world schema.¹¹ The model of adjustment to illness describes how people learn to adjust to living with an illness, which can lead to positive health outcomes. Meaning creation is defined as the process in which people create meaning from their experience living with illness. Self-schema is how people living with illness see themselves, and world schema is how people living with chronic illness see their place in the world. These domains shift as part of the adjustment to living with an illness described in this model.¹¹ This foundation allowed the investigators to explore the experience of living with HF among veterans with a focus on these domains. Our study aimed to cocreate illness narratives among veterans living with HF and to explore components of psychosocial adjustment informed by the model.

Methods

This study used narrative inquiry with a focus on illness narratives.^12-17 Narrative inquiry as defined by Catherine Riessman involves the generation of socially constructed and cocreated meanings between the researcher and narrator. The researcher is an active participant in narrative creation as the narrator chooses which events to include in the stories based on the social, historical, and cultural context of both the narrator (study participant) and audience (researcher). Riessman describes the importance of contextual factors and meaning creation as an important aspect of narrative inquiry.^12-14,16,17 It is important in narrative inquiry to consider how cultural, social, and historical factors influence narrative creation, constriction, and/or elimination.

This study prospectively created and collected data at a single time point. Semi-structured interviews explored psychosocial adjustment for people living with HF using an opening question modified from previous illness narrative research: Why do you think you got heart failure?¹⁸ Probes included the domains of psychosocial adjustment informed by the model of adjustment to illness domains (Figure). Emergent probes were used to illicit additional data around psychosocial adjustment to illness. Data were created and collected in accordance with narrative inquiry during the cocreation of the illness narratives between the researcher and study participants. This interview guide was tested by the first author in preliminary work to prepare for this study.

Allowing for emergent probes and acknowledging the role of the researcher as audience is key to the cocreation of narratives using this methodological framework. Narrators shape their narrative with the audience in mind; they cocreate their narrative with their audience using this type of narrative inquiry.^12,16 What the narrator chooses to include and exclude from their story provides a window into how they see themselves and their world.¹⁹ Audio recordings were used to capture data, allowing for the researcher to take contemporaneous notes exploring contextual considerations to the narrative cocreation process and to be used later in analysis. Analytic notes were completed during the interviews as well as later in analysis as part of the contextual reflection.

Setting

Research was conducted in the Rocky Mountain Regional VA Medical Center, Aurora, Colorado. Participants were recruited through the outpatient cardiology clinic where the interviews also took place. This study was approved through the Colorado Institutional Review Board and Rocky Mountain Regional VA Medical Center (IRB: 19-1064). Participants were identified by the treating cardiologist who was a part of the study team. Interested veterans were introduced to the first author who was stationed in an empty clinic room. The study cardiologist screened to ensure all participants were ≥ 18 years of age and had a diagnosis of HF for > 1 year. Persons with an impairment that could interfere with their ability to construct a narrative were also excluded.

Recruitment took place from October 2019 to January 2020. Three veterans refused participation. Five study participants provided informed consent and were enrolled and interviewed. All interviews were completed in the clinic at the time of consent per participant preference. One-hour long semi-structured interviews were conducted and audio recorded. A demographic form was administered at the end of each interview to capture contextual data. The researcher also kept a reflexive journal and audit trail.

Narrative Analysis

Riessman described general steps to conduct narrative analysis, including transcription, narrative clean-up, consideration of contextual factors, exploration of thematic threads, consideration of larger social narratives, and positioning.¹² The first author read transcripts while listening to the audio recordings to ensure accuracy. With narrative clean-up each narrative was organized to cocreate overall meaning, changed to protect anonymity, and refined to only include the illness narrative. For example, if a narrator told a story about childhood and then later in the interview remembered another detail to add to their story, narrative clean-up reordered events to make cohesive sense of the story. Demographic, historical, cultural, and social contexts of both the narrator and audience were reflected on during analysis to explore how these components may have shaped and influenced cocreation. Context was also considered within the larger VA setting.

Emergent themes were explored for convergence, divergence, and points of tension within and across each narrative. Larger social narratives were also considered for their influence on possible inclusion/exclusion of experience, such as how gender identity may have influenced study participants’ descriptions of their roles in social systems. These themes and narratives were then shared with our team, and we worked through decision points during the analysis process and discussed interpretation of the data to reach consensus.

Results

Five veterans living with HF were recruited and consented to participate in the study. Demographics of the participants and first author are included in the Table. Five illness narratives were cocreated, entitled: Blame the Cheese: Frank’s Illness Narrative; Love is Love: Bob’s Illness Narrative; The Brighter Things in Life is My Family: George’s Illness Narrative; We Never Know When Our Time is Coming: Bill’s Illness Narrative; and A Dream Deferred: Henry’s Illness Narrative.

Each narrative was explored focusing on the domains of the model of adjustment to illness. An emergent theme was also identified with multiple subthemes: being a veteran is unique. Related subthemes included: financial benefits, intersectionality of government and health care, the intersectionality of masculinity and military service, and the dichotomy of military experience.

The search for meaning creation after the experience of chronic illness emerged across interviews. One example of meaning creation was in Frank's illness narrative. Frank was unsure why he got HF: “Probably because I ate too much cheese…I mean, that’s gotta be it. It can’t be anything else.” By tying HF to his diet, he found meaning through his health behaviors.

Model of Adjustment to Illness

The narratives illustrate components of the model of adjustment to illness and describe how each of the participants either shifted their self-schema and world schema or reinforced their previously established schemas. It also demonstrates how people use narratives to create meaning and illness understanding from their illness experience, reflecting, and emphasizing different parts creating meaning from their experience.

A commonality across the narratives was a shift in self-schema, including the shift from being a provider to being reliant on others. In accordance with the dominant social narrative around men as providers, each narrator talked about their identity as a provider for themselves and their families. Often keeping their provider identity required modifications of the definition, from physical abilities and employment to financial security and stability. George made all his health care decisions based on his goal of providing for his family and protecting them from having to care for him: “I’m always thinking about the future, always trying to figure out how my family, if something should happen to me, how my family would cope, and how my family would be able to support themselves.” Bob’s health care goals were to stay alive long enough for his wife to get financial benefits as a surviving spouse: “That’s why I’m trying to make everything for her, you know. I’m not worried about myself. I’m not. Her I am, you know. And love is love.” Both of their health care decisions are shaped by their identity as a provider shifting to financial support.

Veteran Status

Being a veteran in the Veterans Health Administration (VHA) system impacted how a narrative understanding of illness was created. Veterans are a unique cultural population with aspects of their illness experience that are important to understand.¹⁰ Institutions such as the VA also enable and constrain components of narrative creation.²⁰ The illness narratives in this study were cocreated within the institutional setting of the VA. Part of the analysis included exploring how the institutional setting impacted the narrative creation. Emergent subthemes of the uniqueness of the veteran experience include financial benefits, intersectionality of government and health care, intersectionality of masculinity and military service, and the dichotomy of military experience.

In the US it is unique to the VA that the government both treats and assesses the severity of medical conditions to determine eligibility for health care and financial benefits. The VA’s financial benefits are intended to help compensate veterans who are experiencing illness as a result of their military experience.²¹ However, because the VA administers them the Veterans Benefits Administration and the VHA, veterans see both as interconnected. The perceived tie between illness severity and financial compensation could influence or bias how veterans understand their illness severity and experience. This may inadvertently encourage veterans to see their illness as being tied to their military service. This shaping of narratives should be considered as a contextual component as veterans obtain financial compensation and health insurance from the same larger organization that provides their health care and management.

George was a young man who during his service had chest pains and felt tired during physical training. He was surprised when his cardiologist explained his heart was enlarged. “All I know is when I initially joined the military, I was perfectly fine, you know, and when I was in the military, graduating, all that stuff, there was a glitch on the [electrocardiogram] they gave me after one day of doing [physical training] and then they’re like, oh, that’s fine. Come to find out it was mitral valve prolapse. And the doctors didn’t catch it then.” George feels the stress of the military caused his heart problems: “It wasn’t there before… so I’d have to say the strain from the military had to have caused it.” George’s medical history noted that he has a genetic connective tissue disorder that can lead to HF and likely was underlying cause of his illness. This example of how George pruned his narrative experience to highlight the cause as his military experience instead of a genetic disorder could have multiple financial and health benefits. The financial incentive for George to see his illness as caused by his military service could potentially bias his illness narrative to find his illness cause as tied to his service.

Government/Health Care Intersectionality

Veterans who may have experienced trust-breaking events with the government, like Agent Orange exposure or intergenerational racial trauma, may apply that experience to all government agencies. Bob felt the government had purposefully used him to create a military weapon. The army “knew I was angry and they used that for their advantage,” he said. Bob learned that he was exposed to Agent Orange in Vietnam, which is presumed to be associated with HF. Bob felt betrayed that the VHA had not figured out his health problems earlier. “I didn’t know anything about it until 6 months ago… Our government knew about it when they used it, and they didn’t care. They just wanted to win the war, and a whole lot of GIs like me suffered because of that, and I was like my government killed me? And I was fighting for them?”

Henry learned to distrust the government and the health care system because of a long history of systematic oppression and exploitation. These institutions’ erosion of trust has impact beyond the trust-breaking event itself but reverberates into how communities view organizations and institutions for generations. For Black Americans, who have historically been experimented on without consent by the US government and health care systems, this can make it especially hard to trust and build working relationships with those institutions. Health care professionals (HCPs) need to build collaborative partnerships with patients to provide effective care while understanding why some patients may have difficulty trusting health care systems, especially government-led systems.

The nature of HF as an illness can also make it difficult to predict and manage.²² This uncertainty and difficulty in managing HF can make it especially hard for people to establish trust with their HCPs whom they want to see as experts in their illness. HCPs in these narratives were often portrayed as incompetent or neglectful. The unpredictable nature of the illness itself was not reflected in the narrator’s experience.

Masculinity/Military Service Intersectionality

For the veteran narrators, tied into the identity of being a provider are social messages about masculinity. There is a unique intersectionality of being a man, the military culture, and living with chronic illnesses. Dominant social messages around being a man include being tough, not expressing emotion, self-reliance, and having power. This overlaps with social messages on military culture, including self-reliance, toughness, persistence in the face of adversity, limited expression of emotions, and the recognition of power and respect.²³

People who internalize these social messages on masculinity may be less likely to access mental health treatment.²³ This stigmatizing barrier to mental health treatment could impact how positive narratives are constructed around the experience of chronic illness for narrators who identify as masculine. Military and masculine identity could exclude or constrain stories about a veteran who did not “solider on” or who had to rely on others in a team to get things done. This shift can especially impact veterans experiencing chronic illnesses like HF, which often impact their physical abilities. Veterans may feel pressured to think of and portray themselves as being strong by limiting their expression of pain and other symptoms to remain in alignment with the dominant narrative. By not being open about the full experience of their illness both positive and negative, veterans may have unaddressed aspects of their illness experience or HCPs may not be able have all the information they need before the concern becomes a more serious health problem.

Dichotomy of Military Experience

Some narrators in this study talked about their military experience as both traumatic and beneficial. These dichotomous viewpoints can be difficult for veterans to construct a narrative understanding around. How can an inherently painful potentially traumatic experience, such as war, have benefits? This way of looking at the world may require a large narrative shift in their world and self-schemas to accept.

Bob hurt people in Vietnam as part of his job. “I did a lot of killing.” Bob met a village elder who stopped him from hurting people in the village and “in my spare time, I would go back to the village and he would teach me, how to be a better man,” Bob shared. “He taught me about life and everything, and he was awesome, just to this day, he’s like a father to me.” Bob tried to change his life and learned how to live a life full of love and care because of his experience in Vietnam. Though Bob hurt a lot of people in Vietnam, which still haunts him, he found meaning through his life lessons from the village elder. “I’m ashamed of what I did in Vietnam. I did some really bad stuff, but ever since then, I’ve always tried to do good to help people.”

Discussion

Exploring a person’s illness experience from a truly holistic pathway allows HCPs to see how the ripples of illness echo into the interconnection of surrounding systems and even across time. These stories suggest that veterans may experience their illness and construct their illness narratives based on the distinct contextual considerations of veteran culture.¹⁰ Research exploring how veterans see their illness and its potential impact on their health care access and choices could benefit from exploration into narrative understanding and meaning creation as a potentially contributing factor to health care decision making. As veterans are treated across health care systems, this has implications not only for VHA care, but community care as well.

These narratives also demonstrate how veterans create health care goals woven into their narrative understanding of their illness and its cause, lending insight into understanding health care decision making. This change in self-schema shapes how veterans see themselves and their role which shapes other aspects of their health care. These findings also contribute to our understanding of meaning creation. By exploring meaning making and narrative understanding, this work adds to our knowledge of the importance of spirituality as a component of the holistic experience of illness. There have been previous studies exploring the spiritual aspects of HF and the importance of meaning making.^24,25 Exploring meaning making as an aspect of illness narratives can have important implications. Future research could explore the connections between meaning creation and illness narratives.

Limitations

The sample of veterans who participated in this study and are not generalizable to all veteran populations. The sample also only reflects people who were willing to participate and may exclude experience of people who may not have felt comfortable talking to a VA employee about their experience. It is also important to note that the small sample size included primarily male and White participants. In narrative inquiry, the number of participants is not as essential as diving into the depth of the interviews with the participants.

It is also important to note the position of the interviewer. As a White cisgender, heterosexual, middle-aged, middle class female who was raised in rural Kansas in a predominantly Protestant community, the positionality of the interviewer as a cocreator of the data inherently shaped and influenced the narratives created during this study. This contextual understanding of narratives created within the research relationship is an essential component to narrative inquiry and understanding.

Conclusions

Exploring these veterans’ narrative understanding of their experience of illness has many potential implications for health care systems, HCPs, and our military and veteran populations described in this article. Thinking about how the impact of racism, the influence of incentives to remain ill, and the complex intersection of identity and health brings light to how these domains may influence how people see themselves and engage in health care. These domains from these stories of the heart may help millions of people living with chronic illnesses like HF to not only live with their illness but inform how their experience is shaped by the systems surrounding them, including health care, government, and systems of power and oppression.

Heart failure (HF) is a costly and burdensome illness and is the top reason for hospital admissions for the US Department of Veterans Affairs (VA) and Medicare.¹ The cost of HF to the United States is estimated to grow to $3 billion annually by 2030.² People living with HF have a high symptom burden and poor quality of life.^3,4 Symptoms include shortness of breath, fatigue, depression, and decreases in psychosocial, existential, and spiritual well-being.^5-9

Veterans in the US are a unique cultural group with distinct contextual considerations around their experiences.¹⁰ Different groups of veterans require unique cultural considerations, such as the experiences of veterans who served during the Vietnam war and during Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF). The extent of unmet needs of people living with HF, the number of veterans living with this illness, and the unique contextual components related to living with HF among veterans require further exploration into this illness experience for this distinct population. Research should explore innovative ways of managing both the number of people living with the illness and the significant impact of HF in people’s lives due to the high symptom burden and poor quality of life.³

This study used the model of adjustment to illness to explore the psychosocial adjustment to illness and the experience of US veterans living with HF, with a focus on the domains of meaning creation, self-schema, and world schema.¹¹ The model of adjustment to illness describes how people learn to adjust to living with an illness, which can lead to positive health outcomes. Meaning creation is defined as the process in which people create meaning from their experience living with illness. Self-schema is how people living with illness see themselves, and world schema is how people living with chronic illness see their place in the world. These domains shift as part of the adjustment to living with an illness described in this model.¹¹ This foundation allowed the investigators to explore the experience of living with HF among veterans with a focus on these domains. Our study aimed to cocreate illness narratives among veterans living with HF and to explore components of psychosocial adjustment informed by the model.

Methods

This study used narrative inquiry with a focus on illness narratives.^12-17 Narrative inquiry as defined by Catherine Riessman involves the generation of socially constructed and cocreated meanings between the researcher and narrator. The researcher is an active participant in narrative creation as the narrator chooses which events to include in the stories based on the social, historical, and cultural context of both the narrator (study participant) and audience (researcher). Riessman describes the importance of contextual factors and meaning creation as an important aspect of narrative inquiry.^12-14,16,17 It is important in narrative inquiry to consider how cultural, social, and historical factors influence narrative creation, constriction, and/or elimination.

This study prospectively created and collected data at a single time point. Semi-structured interviews explored psychosocial adjustment for people living with HF using an opening question modified from previous illness narrative research: Why do you think you got heart failure?¹⁸ Probes included the domains of psychosocial adjustment informed by the model of adjustment to illness domains (Figure). Emergent probes were used to illicit additional data around psychosocial adjustment to illness. Data were created and collected in accordance with narrative inquiry during the cocreation of the illness narratives between the researcher and study participants. This interview guide was tested by the first author in preliminary work to prepare for this study.

Allowing for emergent probes and acknowledging the role of the researcher as audience is key to the cocreation of narratives using this methodological framework. Narrators shape their narrative with the audience in mind; they cocreate their narrative with their audience using this type of narrative inquiry.^12,16 What the narrator chooses to include and exclude from their story provides a window into how they see themselves and their world.¹⁹ Audio recordings were used to capture data, allowing for the researcher to take contemporaneous notes exploring contextual considerations to the narrative cocreation process and to be used later in analysis. Analytic notes were completed during the interviews as well as later in analysis as part of the contextual reflection.

Setting

Research was conducted in the Rocky Mountain Regional VA Medical Center, Aurora, Colorado. Participants were recruited through the outpatient cardiology clinic where the interviews also took place. This study was approved through the Colorado Institutional Review Board and Rocky Mountain Regional VA Medical Center (IRB: 19-1064). Participants were identified by the treating cardiologist who was a part of the study team. Interested veterans were introduced to the first author who was stationed in an empty clinic room. The study cardiologist screened to ensure all participants were ≥ 18 years of age and had a diagnosis of HF for > 1 year. Persons with an impairment that could interfere with their ability to construct a narrative were also excluded.

Recruitment took place from October 2019 to January 2020. Three veterans refused participation. Five study participants provided informed consent and were enrolled and interviewed. All interviews were completed in the clinic at the time of consent per participant preference. One-hour long semi-structured interviews were conducted and audio recorded. A demographic form was administered at the end of each interview to capture contextual data. The researcher also kept a reflexive journal and audit trail.

Narrative Analysis

Riessman described general steps to conduct narrative analysis, including transcription, narrative clean-up, consideration of contextual factors, exploration of thematic threads, consideration of larger social narratives, and positioning.¹² The first author read transcripts while listening to the audio recordings to ensure accuracy. With narrative clean-up each narrative was organized to cocreate overall meaning, changed to protect anonymity, and refined to only include the illness narrative. For example, if a narrator told a story about childhood and then later in the interview remembered another detail to add to their story, narrative clean-up reordered events to make cohesive sense of the story. Demographic, historical, cultural, and social contexts of both the narrator and audience were reflected on during analysis to explore how these components may have shaped and influenced cocreation. Context was also considered within the larger VA setting.

Emergent themes were explored for convergence, divergence, and points of tension within and across each narrative. Larger social narratives were also considered for their influence on possible inclusion/exclusion of experience, such as how gender identity may have influenced study participants’ descriptions of their roles in social systems. These themes and narratives were then shared with our team, and we worked through decision points during the analysis process and discussed interpretation of the data to reach consensus.

Results

Five veterans living with HF were recruited and consented to participate in the study. Demographics of the participants and first author are included in the Table. Five illness narratives were cocreated, entitled: Blame the Cheese: Frank’s Illness Narrative; Love is Love: Bob’s Illness Narrative; The Brighter Things in Life is My Family: George’s Illness Narrative; We Never Know When Our Time is Coming: Bill’s Illness Narrative; and A Dream Deferred: Henry’s Illness Narrative.

Each narrative was explored focusing on the domains of the model of adjustment to illness. An emergent theme was also identified with multiple subthemes: being a veteran is unique. Related subthemes included: financial benefits, intersectionality of government and health care, the intersectionality of masculinity and military service, and the dichotomy of military experience.

The search for meaning creation after the experience of chronic illness emerged across interviews. One example of meaning creation was in Frank's illness narrative. Frank was unsure why he got HF: “Probably because I ate too much cheese…I mean, that’s gotta be it. It can’t be anything else.” By tying HF to his diet, he found meaning through his health behaviors.

Model of Adjustment to Illness

The narratives illustrate components of the model of adjustment to illness and describe how each of the participants either shifted their self-schema and world schema or reinforced their previously established schemas. It also demonstrates how people use narratives to create meaning and illness understanding from their illness experience, reflecting, and emphasizing different parts creating meaning from their experience.

A commonality across the narratives was a shift in self-schema, including the shift from being a provider to being reliant on others. In accordance with the dominant social narrative around men as providers, each narrator talked about their identity as a provider for themselves and their families. Often keeping their provider identity required modifications of the definition, from physical abilities and employment to financial security and stability. George made all his health care decisions based on his goal of providing for his family and protecting them from having to care for him: “I’m always thinking about the future, always trying to figure out how my family, if something should happen to me, how my family would cope, and how my family would be able to support themselves.” Bob’s health care goals were to stay alive long enough for his wife to get financial benefits as a surviving spouse: “That’s why I’m trying to make everything for her, you know. I’m not worried about myself. I’m not. Her I am, you know. And love is love.” Both of their health care decisions are shaped by their identity as a provider shifting to financial support.

Veteran Status

Being a veteran in the Veterans Health Administration (VHA) system impacted how a narrative understanding of illness was created. Veterans are a unique cultural population with aspects of their illness experience that are important to understand.¹⁰ Institutions such as the VA also enable and constrain components of narrative creation.²⁰ The illness narratives in this study were cocreated within the institutional setting of the VA. Part of the analysis included exploring how the institutional setting impacted the narrative creation. Emergent subthemes of the uniqueness of the veteran experience include financial benefits, intersectionality of government and health care, intersectionality of masculinity and military service, and the dichotomy of military experience.

In the US it is unique to the VA that the government both treats and assesses the severity of medical conditions to determine eligibility for health care and financial benefits. The VA’s financial benefits are intended to help compensate veterans who are experiencing illness as a result of their military experience.²¹ However, because the VA administers them the Veterans Benefits Administration and the VHA, veterans see both as interconnected. The perceived tie between illness severity and financial compensation could influence or bias how veterans understand their illness severity and experience. This may inadvertently encourage veterans to see their illness as being tied to their military service. This shaping of narratives should be considered as a contextual component as veterans obtain financial compensation and health insurance from the same larger organization that provides their health care and management.

George was a young man who during his service had chest pains and felt tired during physical training. He was surprised when his cardiologist explained his heart was enlarged. “All I know is when I initially joined the military, I was perfectly fine, you know, and when I was in the military, graduating, all that stuff, there was a glitch on the [electrocardiogram] they gave me after one day of doing [physical training] and then they’re like, oh, that’s fine. Come to find out it was mitral valve prolapse. And the doctors didn’t catch it then.” George feels the stress of the military caused his heart problems: “It wasn’t there before… so I’d have to say the strain from the military had to have caused it.” George’s medical history noted that he has a genetic connective tissue disorder that can lead to HF and likely was underlying cause of his illness. This example of how George pruned his narrative experience to highlight the cause as his military experience instead of a genetic disorder could have multiple financial and health benefits. The financial incentive for George to see his illness as caused by his military service could potentially bias his illness narrative to find his illness cause as tied to his service.

Government/Health Care Intersectionality

Veterans who may have experienced trust-breaking events with the government, like Agent Orange exposure or intergenerational racial trauma, may apply that experience to all government agencies. Bob felt the government had purposefully used him to create a military weapon. The army “knew I was angry and they used that for their advantage,” he said. Bob learned that he was exposed to Agent Orange in Vietnam, which is presumed to be associated with HF. Bob felt betrayed that the VHA had not figured out his health problems earlier. “I didn’t know anything about it until 6 months ago… Our government knew about it when they used it, and they didn’t care. They just wanted to win the war, and a whole lot of GIs like me suffered because of that, and I was like my government killed me? And I was fighting for them?”

Henry learned to distrust the government and the health care system because of a long history of systematic oppression and exploitation. These institutions’ erosion of trust has impact beyond the trust-breaking event itself but reverberates into how communities view organizations and institutions for generations. For Black Americans, who have historically been experimented on without consent by the US government and health care systems, this can make it especially hard to trust and build working relationships with those institutions. Health care professionals (HCPs) need to build collaborative partnerships with patients to provide effective care while understanding why some patients may have difficulty trusting health care systems, especially government-led systems.

The nature of HF as an illness can also make it difficult to predict and manage.²² This uncertainty and difficulty in managing HF can make it especially hard for people to establish trust with their HCPs whom they want to see as experts in their illness. HCPs in these narratives were often portrayed as incompetent or neglectful. The unpredictable nature of the illness itself was not reflected in the narrator’s experience.

Masculinity/Military Service Intersectionality

For the veteran narrators, tied into the identity of being a provider are social messages about masculinity. There is a unique intersectionality of being a man, the military culture, and living with chronic illnesses. Dominant social messages around being a man include being tough, not expressing emotion, self-reliance, and having power. This overlaps with social messages on military culture, including self-reliance, toughness, persistence in the face of adversity, limited expression of emotions, and the recognition of power and respect.²³

People who internalize these social messages on masculinity may be less likely to access mental health treatment.²³ This stigmatizing barrier to mental health treatment could impact how positive narratives are constructed around the experience of chronic illness for narrators who identify as masculine. Military and masculine identity could exclude or constrain stories about a veteran who did not “solider on” or who had to rely on others in a team to get things done. This shift can especially impact veterans experiencing chronic illnesses like HF, which often impact their physical abilities. Veterans may feel pressured to think of and portray themselves as being strong by limiting their expression of pain and other symptoms to remain in alignment with the dominant narrative. By not being open about the full experience of their illness both positive and negative, veterans may have unaddressed aspects of their illness experience or HCPs may not be able have all the information they need before the concern becomes a more serious health problem.

Dichotomy of Military Experience

Some narrators in this study talked about their military experience as both traumatic and beneficial. These dichotomous viewpoints can be difficult for veterans to construct a narrative understanding around. How can an inherently painful potentially traumatic experience, such as war, have benefits? This way of looking at the world may require a large narrative shift in their world and self-schemas to accept.

Bob hurt people in Vietnam as part of his job. “I did a lot of killing.” Bob met a village elder who stopped him from hurting people in the village and “in my spare time, I would go back to the village and he would teach me, how to be a better man,” Bob shared. “He taught me about life and everything, and he was awesome, just to this day, he’s like a father to me.” Bob tried to change his life and learned how to live a life full of love and care because of his experience in Vietnam. Though Bob hurt a lot of people in Vietnam, which still haunts him, he found meaning through his life lessons from the village elder. “I’m ashamed of what I did in Vietnam. I did some really bad stuff, but ever since then, I’ve always tried to do good to help people.”

Discussion

Exploring a person’s illness experience from a truly holistic pathway allows HCPs to see how the ripples of illness echo into the interconnection of surrounding systems and even across time. These stories suggest that veterans may experience their illness and construct their illness narratives based on the distinct contextual considerations of veteran culture.¹⁰ Research exploring how veterans see their illness and its potential impact on their health care access and choices could benefit from exploration into narrative understanding and meaning creation as a potentially contributing factor to health care decision making. As veterans are treated across health care systems, this has implications not only for VHA care, but community care as well.

These narratives also demonstrate how veterans create health care goals woven into their narrative understanding of their illness and its cause, lending insight into understanding health care decision making. This change in self-schema shapes how veterans see themselves and their role which shapes other aspects of their health care. These findings also contribute to our understanding of meaning creation. By exploring meaning making and narrative understanding, this work adds to our knowledge of the importance of spirituality as a component of the holistic experience of illness. There have been previous studies exploring the spiritual aspects of HF and the importance of meaning making.^24,25 Exploring meaning making as an aspect of illness narratives can have important implications. Future research could explore the connections between meaning creation and illness narratives.

Limitations

The sample of veterans who participated in this study and are not generalizable to all veteran populations. The sample also only reflects people who were willing to participate and may exclude experience of people who may not have felt comfortable talking to a VA employee about their experience. It is also important to note that the small sample size included primarily male and White participants. In narrative inquiry, the number of participants is not as essential as diving into the depth of the interviews with the participants.

It is also important to note the position of the interviewer. As a White cisgender, heterosexual, middle-aged, middle class female who was raised in rural Kansas in a predominantly Protestant community, the positionality of the interviewer as a cocreator of the data inherently shaped and influenced the narratives created during this study. This contextual understanding of narratives created within the research relationship is an essential component to narrative inquiry and understanding.

Conclusions

Exploring these veterans’ narrative understanding of their experience of illness has many potential implications for health care systems, HCPs, and our military and veteran populations described in this article. Thinking about how the impact of racism, the influence of incentives to remain ill, and the complex intersection of identity and health brings light to how these domains may influence how people see themselves and engage in health care. These domains from these stories of the heart may help millions of people living with chronic illnesses like HF to not only live with their illness but inform how their experience is shaped by the systems surrounding them, including health care, government, and systems of power and oppression.

Heart failure (HF) is a costly and burdensome illness and is the top reason for hospital admissions for the US Department of Veterans Affairs (VA) and Medicare.¹ The cost of HF to the United States is estimated to grow to $3 billion annually by 2030.² People living with HF have a high symptom burden and poor quality of life.^3,4 Symptoms include shortness of breath, fatigue, depression, and decreases in psychosocial, existential, and spiritual well-being.^5-9

Veterans in the US are a unique cultural group with distinct contextual considerations around their experiences.¹⁰ Different groups of veterans require unique cultural considerations, such as the experiences of veterans who served during the Vietnam war and during Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF). The extent of unmet needs of people living with HF, the number of veterans living with this illness, and the unique contextual components related to living with HF among veterans require further exploration into this illness experience for this distinct population. Research should explore innovative ways of managing both the number of people living with the illness and the significant impact of HF in people’s lives due to the high symptom burden and poor quality of life.³

This study used the model of adjustment to illness to explore the psychosocial adjustment to illness and the experience of US veterans living with HF, with a focus on the domains of meaning creation, self-schema, and world schema.¹¹ The model of adjustment to illness describes how people learn to adjust to living with an illness, which can lead to positive health outcomes. Meaning creation is defined as the process in which people create meaning from their experience living with illness. Self-schema is how people living with illness see themselves, and world schema is how people living with chronic illness see their place in the world. These domains shift as part of the adjustment to living with an illness described in this model.¹¹ This foundation allowed the investigators to explore the experience of living with HF among veterans with a focus on these domains. Our study aimed to cocreate illness narratives among veterans living with HF and to explore components of psychosocial adjustment informed by the model.

Methods

This study used narrative inquiry with a focus on illness narratives.^12-17 Narrative inquiry as defined by Catherine Riessman involves the generation of socially constructed and cocreated meanings between the researcher and narrator. The researcher is an active participant in narrative creation as the narrator chooses which events to include in the stories based on the social, historical, and cultural context of both the narrator (study participant) and audience (researcher). Riessman describes the importance of contextual factors and meaning creation as an important aspect of narrative inquiry.^12-14,16,17 It is important in narrative inquiry to consider how cultural, social, and historical factors influence narrative creation, constriction, and/or elimination.

This study prospectively created and collected data at a single time point. Semi-structured interviews explored psychosocial adjustment for people living with HF using an opening question modified from previous illness narrative research: Why do you think you got heart failure?¹⁸ Probes included the domains of psychosocial adjustment informed by the model of adjustment to illness domains (Figure). Emergent probes were used to illicit additional data around psychosocial adjustment to illness. Data were created and collected in accordance with narrative inquiry during the cocreation of the illness narratives between the researcher and study participants. This interview guide was tested by the first author in preliminary work to prepare for this study.

Allowing for emergent probes and acknowledging the role of the researcher as audience is key to the cocreation of narratives using this methodological framework. Narrators shape their narrative with the audience in mind; they cocreate their narrative with their audience using this type of narrative inquiry.^12,16 What the narrator chooses to include and exclude from their story provides a window into how they see themselves and their world.¹⁹ Audio recordings were used to capture data, allowing for the researcher to take contemporaneous notes exploring contextual considerations to the narrative cocreation process and to be used later in analysis. Analytic notes were completed during the interviews as well as later in analysis as part of the contextual reflection.

Setting

Research was conducted in the Rocky Mountain Regional VA Medical Center, Aurora, Colorado. Participants were recruited through the outpatient cardiology clinic where the interviews also took place. This study was approved through the Colorado Institutional Review Board and Rocky Mountain Regional VA Medical Center (IRB: 19-1064). Participants were identified by the treating cardiologist who was a part of the study team. Interested veterans were introduced to the first author who was stationed in an empty clinic room. The study cardiologist screened to ensure all participants were ≥ 18 years of age and had a diagnosis of HF for > 1 year. Persons with an impairment that could interfere with their ability to construct a narrative were also excluded.

Recruitment took place from October 2019 to January 2020. Three veterans refused participation. Five study participants provided informed consent and were enrolled and interviewed. All interviews were completed in the clinic at the time of consent per participant preference. One-hour long semi-structured interviews were conducted and audio recorded. A demographic form was administered at the end of each interview to capture contextual data. The researcher also kept a reflexive journal and audit trail.

Narrative Analysis

Riessman described general steps to conduct narrative analysis, including transcription, narrative clean-up, consideration of contextual factors, exploration of thematic threads, consideration of larger social narratives, and positioning.¹² The first author read transcripts while listening to the audio recordings to ensure accuracy. With narrative clean-up each narrative was organized to cocreate overall meaning, changed to protect anonymity, and refined to only include the illness narrative. For example, if a narrator told a story about childhood and then later in the interview remembered another detail to add to their story, narrative clean-up reordered events to make cohesive sense of the story. Demographic, historical, cultural, and social contexts of both the narrator and audience were reflected on during analysis to explore how these components may have shaped and influenced cocreation. Context was also considered within the larger VA setting.

Emergent themes were explored for convergence, divergence, and points of tension within and across each narrative. Larger social narratives were also considered for their influence on possible inclusion/exclusion of experience, such as how gender identity may have influenced study participants’ descriptions of their roles in social systems. These themes and narratives were then shared with our team, and we worked through decision points during the analysis process and discussed interpretation of the data to reach consensus.

Results

Five veterans living with HF were recruited and consented to participate in the study. Demographics of the participants and first author are included in the Table. Five illness narratives were cocreated, entitled: Blame the Cheese: Frank’s Illness Narrative; Love is Love: Bob’s Illness Narrative; The Brighter Things in Life is My Family: George’s Illness Narrative; We Never Know When Our Time is Coming: Bill’s Illness Narrative; and A Dream Deferred: Henry’s Illness Narrative.

Each narrative was explored focusing on the domains of the model of adjustment to illness. An emergent theme was also identified with multiple subthemes: being a veteran is unique. Related subthemes included: financial benefits, intersectionality of government and health care, the intersectionality of masculinity and military service, and the dichotomy of military experience.

The search for meaning creation after the experience of chronic illness emerged across interviews. One example of meaning creation was in Frank's illness narrative. Frank was unsure why he got HF: “Probably because I ate too much cheese…I mean, that’s gotta be it. It can’t be anything else.” By tying HF to his diet, he found meaning through his health behaviors.

Model of Adjustment to Illness

The narratives illustrate components of the model of adjustment to illness and describe how each of the participants either shifted their self-schema and world schema or reinforced their previously established schemas. It also demonstrates how people use narratives to create meaning and illness understanding from their illness experience, reflecting, and emphasizing different parts creating meaning from their experience.

A commonality across the narratives was a shift in self-schema, including the shift from being a provider to being reliant on others. In accordance with the dominant social narrative around men as providers, each narrator talked about their identity as a provider for themselves and their families. Often keeping their provider identity required modifications of the definition, from physical abilities and employment to financial security and stability. George made all his health care decisions based on his goal of providing for his family and protecting them from having to care for him: “I’m always thinking about the future, always trying to figure out how my family, if something should happen to me, how my family would cope, and how my family would be able to support themselves.” Bob’s health care goals were to stay alive long enough for his wife to get financial benefits as a surviving spouse: “That’s why I’m trying to make everything for her, you know. I’m not worried about myself. I’m not. Her I am, you know. And love is love.” Both of their health care decisions are shaped by their identity as a provider shifting to financial support.

Veteran Status

Being a veteran in the Veterans Health Administration (VHA) system impacted how a narrative understanding of illness was created. Veterans are a unique cultural population with aspects of their illness experience that are important to understand.¹⁰ Institutions such as the VA also enable and constrain components of narrative creation.²⁰ The illness narratives in this study were cocreated within the institutional setting of the VA. Part of the analysis included exploring how the institutional setting impacted the narrative creation. Emergent subthemes of the uniqueness of the veteran experience include financial benefits, intersectionality of government and health care, intersectionality of masculinity and military service, and the dichotomy of military experience.

In the US it is unique to the VA that the government both treats and assesses the severity of medical conditions to determine eligibility for health care and financial benefits. The VA’s financial benefits are intended to help compensate veterans who are experiencing illness as a result of their military experience.²¹ However, because the VA administers them the Veterans Benefits Administration and the VHA, veterans see both as interconnected. The perceived tie between illness severity and financial compensation could influence or bias how veterans understand their illness severity and experience. This may inadvertently encourage veterans to see their illness as being tied to their military service. This shaping of narratives should be considered as a contextual component as veterans obtain financial compensation and health insurance from the same larger organization that provides their health care and management.

George was a young man who during his service had chest pains and felt tired during physical training. He was surprised when his cardiologist explained his heart was enlarged. “All I know is when I initially joined the military, I was perfectly fine, you know, and when I was in the military, graduating, all that stuff, there was a glitch on the [electrocardiogram] they gave me after one day of doing [physical training] and then they’re like, oh, that’s fine. Come to find out it was mitral valve prolapse. And the doctors didn’t catch it then.” George feels the stress of the military caused his heart problems: “It wasn’t there before… so I’d have to say the strain from the military had to have caused it.” George’s medical history noted that he has a genetic connective tissue disorder that can lead to HF and likely was underlying cause of his illness. This example of how George pruned his narrative experience to highlight the cause as his military experience instead of a genetic disorder could have multiple financial and health benefits. The financial incentive for George to see his illness as caused by his military service could potentially bias his illness narrative to find his illness cause as tied to his service.

Government/Health Care Intersectionality

Veterans who may have experienced trust-breaking events with the government, like Agent Orange exposure or intergenerational racial trauma, may apply that experience to all government agencies. Bob felt the government had purposefully used him to create a military weapon. The army “knew I was angry and they used that for their advantage,” he said. Bob learned that he was exposed to Agent Orange in Vietnam, which is presumed to be associated with HF. Bob felt betrayed that the VHA had not figured out his health problems earlier. “I didn’t know anything about it until 6 months ago… Our government knew about it when they used it, and they didn’t care. They just wanted to win the war, and a whole lot of GIs like me suffered because of that, and I was like my government killed me? And I was fighting for them?”

Henry learned to distrust the government and the health care system because of a long history of systematic oppression and exploitation. These institutions’ erosion of trust has impact beyond the trust-breaking event itself but reverberates into how communities view organizations and institutions for generations. For Black Americans, who have historically been experimented on without consent by the US government and health care systems, this can make it especially hard to trust and build working relationships with those institutions. Health care professionals (HCPs) need to build collaborative partnerships with patients to provide effective care while understanding why some patients may have difficulty trusting health care systems, especially government-led systems.

The nature of HF as an illness can also make it difficult to predict and manage.²² This uncertainty and difficulty in managing HF can make it especially hard for people to establish trust with their HCPs whom they want to see as experts in their illness. HCPs in these narratives were often portrayed as incompetent or neglectful. The unpredictable nature of the illness itself was not reflected in the narrator’s experience.

Masculinity/Military Service Intersectionality

For the veteran narrators, tied into the identity of being a provider are social messages about masculinity. There is a unique intersectionality of being a man, the military culture, and living with chronic illnesses. Dominant social messages around being a man include being tough, not expressing emotion, self-reliance, and having power. This overlaps with social messages on military culture, including self-reliance, toughness, persistence in the face of adversity, limited expression of emotions, and the recognition of power and respect.²³

People who internalize these social messages on masculinity may be less likely to access mental health treatment.²³ This stigmatizing barrier to mental health treatment could impact how positive narratives are constructed around the experience of chronic illness for narrators who identify as masculine. Military and masculine identity could exclude or constrain stories about a veteran who did not “solider on” or who had to rely on others in a team to get things done. This shift can especially impact veterans experiencing chronic illnesses like HF, which often impact their physical abilities. Veterans may feel pressured to think of and portray themselves as being strong by limiting their expression of pain and other symptoms to remain in alignment with the dominant narrative. By not being open about the full experience of their illness both positive and negative, veterans may have unaddressed aspects of their illness experience or HCPs may not be able have all the information they need before the concern becomes a more serious health problem.

Dichotomy of Military Experience

Some narrators in this study talked about their military experience as both traumatic and beneficial. These dichotomous viewpoints can be difficult for veterans to construct a narrative understanding around. How can an inherently painful potentially traumatic experience, such as war, have benefits? This way of looking at the world may require a large narrative shift in their world and self-schemas to accept.

Bob hurt people in Vietnam as part of his job. “I did a lot of killing.” Bob met a village elder who stopped him from hurting people in the village and “in my spare time, I would go back to the village and he would teach me, how to be a better man,” Bob shared. “He taught me about life and everything, and he was awesome, just to this day, he’s like a father to me.” Bob tried to change his life and learned how to live a life full of love and care because of his experience in Vietnam. Though Bob hurt a lot of people in Vietnam, which still haunts him, he found meaning through his life lessons from the village elder. “I’m ashamed of what I did in Vietnam. I did some really bad stuff, but ever since then, I’ve always tried to do good to help people.”

Discussion

Exploring a person’s illness experience from a truly holistic pathway allows HCPs to see how the ripples of illness echo into the interconnection of surrounding systems and even across time. These stories suggest that veterans may experience their illness and construct their illness narratives based on the distinct contextual considerations of veteran culture.¹⁰ Research exploring how veterans see their illness and its potential impact on their health care access and choices could benefit from exploration into narrative understanding and meaning creation as a potentially contributing factor to health care decision making. As veterans are treated across health care systems, this has implications not only for VHA care, but community care as well.

These narratives also demonstrate how veterans create health care goals woven into their narrative understanding of their illness and its cause, lending insight into understanding health care decision making. This change in self-schema shapes how veterans see themselves and their role which shapes other aspects of their health care. These findings also contribute to our understanding of meaning creation. By exploring meaning making and narrative understanding, this work adds to our knowledge of the importance of spirituality as a component of the holistic experience of illness. There have been previous studies exploring the spiritual aspects of HF and the importance of meaning making.^24,25 Exploring meaning making as an aspect of illness narratives can have important implications. Future research could explore the connections between meaning creation and illness narratives.

Limitations

The sample of veterans who participated in this study and are not generalizable to all veteran populations. The sample also only reflects people who were willing to participate and may exclude experience of people who may not have felt comfortable talking to a VA employee about their experience. It is also important to note that the small sample size included primarily male and White participants. In narrative inquiry, the number of participants is not as essential as diving into the depth of the interviews with the participants.

It is also important to note the position of the interviewer. As a White cisgender, heterosexual, middle-aged, middle class female who was raised in rural Kansas in a predominantly Protestant community, the positionality of the interviewer as a cocreator of the data inherently shaped and influenced the narratives created during this study. This contextual understanding of narratives created within the research relationship is an essential component to narrative inquiry and understanding.

Conclusions

Exploring these veterans’ narrative understanding of their experience of illness has many potential implications for health care systems, HCPs, and our military and veteran populations described in this article. Thinking about how the impact of racism, the influence of incentives to remain ill, and the complex intersection of identity and health brings light to how these domains may influence how people see themselves and engage in health care. These domains from these stories of the heart may help millions of people living with chronic illnesses like HF to not only live with their illness but inform how their experience is shaped by the systems surrounding them, including health care, government, and systems of power and oppression.

Madhu Manivannan, a third-year medical student at Emory University, Atlanta, is on the vanguard of a new approach to clinical education. Ms. Manivannan, copresident of Emory Medical Students for Climate Action, was in the first class of Emory’s medical students to experience the birth of a refined curriculum – lobbied for and partially created by students themselves. The new course of study addresses the myriad ways climate affects health: from air pollution and its effects on the lungs and cardiovascular system to heat-related kidney disease.

“We have known that climate has affected health for decades,” Ms. Manivannan said in a recent interview. “The narrative used to be that icebergs were melting and in 2050 polar bears would be extinct. The piece that’s different now is people are linking climate to increases in asthma and various diseases. We have a way to directly communicate that it’s not a far-off thing. It’s happening to your friends and family right now.”

Hospitals, medical schools, and public health programs are stepping up to educate the next generation of doctors as well as veteran medical workers on one of the most widespread, insidious health threats of our time – climate change – and specific ways it could affect their patients.

Although climate change may seem to many Americans like a distant threat, Marilyn Howarth, MD, a pediatrician in Philadelphia, is trying to make sure physicians are better prepared to treat a growing number of health problems associated with global warming.

“There isn’t a lot of education for pediatricians and internists on environmental health issues. It has not been a standard part of education in medical school or residency training,” Dr. Howarth, deputy director of the new Philadelphia Regional Center for Children’s Environmental Health, said. “With increasing attention on our climate, we really recognize there’s a real gap in physician knowledge, both in pediatric and adult care.”

Scientists have found that climate change can alter just about every system within the human body. Studies show that more extreme weather events, such as heat waves, thunderstorms, and floods, can worsen asthma and produce more pollen and mold, triggering debilitating respiratory problems.

According to the American Lung Association, ultrafine particles of air pollution can be inhaled and then travel throughout the bloodstream, wreaking havoc on organs and increasing risk of heart attack and stroke. Various types of air pollution also cause changes to the climate by trapping heat in the atmosphere, which leads to problems such as rising sea levels and extreme weather. Plus, in a new study published in Nature, scientists warn that warming climates are forcing animals to migrate to different areas, raising the risk that new infectious diseases will hop from animals – such as bats – to humans, a process called “zoonotic spillover” that many researchers believe is responsible for the COVID-19 pandemic.
 

The Philadelphia Regional Center for Children’s Environmental Health

One of the latest initiatives aimed at disseminating information about children’s health to health care providers is the Philadelphia Regional Center for Children’s Environmental Health, part of Children’s Hospital of Philadelphia and Penn Medicine. CHOP and Penn Medicine are jointly funding this center’s work, which will include educating health care providers on how to better screen for climate-caused health risks and treat related conditions, such as lead poisoning and asthma.

Outreach will focus on providers who treat patients with illnesses that researchers have linked to climate change, Dr. Howarth said. The center will offer clinicians access to seminars and webinars, along with online resources to help doctors treat environmental illnesses. For example, doctors at CHOP’s Poison Control Center are developing a toolkit for physicians to treat patients with elevated levels of lead in the blood. Scientists have linked extreme weather events related to climate change to flooding that pushes metals away from river banks where they were previously contained, allowing them to more easily contaminate homes, soils, and yards.

The initiative builds on CHOP’s Community Asthma Prevention Program (CAPP), which was launched in 1997 by Tyra Bryant-Stephens, MD, its current medical director. CAPP deploys community health workers into homes armed with supplies and tips for managing asthma. The new center will use similar tactics to provide education and resources to patients. The goal is to reach as many at-risk local children as possible.
 

Future generation of doctors fuel growth in climate change education

Lisa Doggett, MD, cofounder and president of the board of directors of Texas Physicians for Social Responsibility, announced in March that the University of Texas at Austin, Baylor College of Medicine, Houston, and the University of Texas Southwestern in Dallas have all decided to begin offering a course on environmental threats. Emory’s new curriculum has become more comprehensive every year since its start – thanks in part to the input of students like Ms. Manivannan. Faculty members tasked her with approving the new additions to the curriculum on how climate affects health, which in 2019 had consisted of a few slides about issues such as extreme heat exposure and air pollution and their effects on childbirth outcomes.

Material on climate change has now been woven into 13 courses. It is discussed at length in relation to pulmonology, cardiology, and gastropulmonology, for example, said Rebecca Philipsborn, MD, MPA, FAAP, faculty lead for the environmental and health curriculum at Emory.

The curriculum has only been incorporated into Emory’s program for the past 2 years. Dr. Philipsborn said the school plans to expand it to the clinical years to help trainees learn to treat conditions such as pediatric asthma.

“In the past few years, there has been so much momentum, and part of that is a testament to already seeing effects of climate change and how they affect delivery of health care,” she said.

At least one medical journal has recently ramped up its efforts to educate physicians on the links between health issues and climate change. Editors of Family Practice, from Oxford University Press, have announced that they plan to publish a special Climate Crisis and Primary Health Care issue in September.

Of course, not all climate initiatives in medicine are new. A select few have existed for decades.

But only now are physicians widely seeing the links between health and environment, according to Aaron Bernstein, MD, MPH, interim director of the Center for Climate, Health, and the Global Environment (C-CHANGE) at Harvard School of Public Health, Boston.

C-CHANGE, founded in 1996, was the first center in the world to focus on the health effects of environmental change.

“It’s taken 20 years, but what we’re seeing, I think, is the fruits of education,” Dr. Bernstein said. “There’s clearly a wave building here, and I think it really started with education and people younger than the people in charge calling them into account.”

Like the Philadelphia center, Harvard’s program conducts research on climate and health and educates people from high schoolers to health care veterans. Dr. Bernstein helps lead Climate MD, a program that aims to prepare health care workers for climate crises. The Climate MD team has published several articles in peer-reviewed journals on how to better treat patients struggling with environmental health problems. For example, an article on mapping patients in hurricane zones helped shed light on how systems can identify climate-vulnerable patients using public data.

They also developed a tool to help pediatricians provide “climate-informed primary care” – guidance on how to assess whether children are at risk of any harmful environmental exposures, a feature that is not part of standard pediatric visits.

Like the other programs, Climate MD uses community outreach to treat as many local patients as possible. Staff work with providers at more than 100 health clinics, particularly in areas where climate change disproportionately affects residents.

The next major step is to bring some of this into clinical practice, Dr. Bernstein said. In February 2020, C-CHANGE held its first symposium to address that issue.

“The key is to understand climate issues from a provider’s perspective,” he said. “Then those issues can really be brought to the bedside.”

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

Madhu Manivannan, a third-year medical student at Emory University, Atlanta, is on the vanguard of a new approach to clinical education. Ms. Manivannan, copresident of Emory Medical Students for Climate Action, was in the first class of Emory’s medical students to experience the birth of a refined curriculum – lobbied for and partially created by students themselves. The new course of study addresses the myriad ways climate affects health: from air pollution and its effects on the lungs and cardiovascular system to heat-related kidney disease.

“We have known that climate has affected health for decades,” Ms. Manivannan said in a recent interview. “The narrative used to be that icebergs were melting and in 2050 polar bears would be extinct. The piece that’s different now is people are linking climate to increases in asthma and various diseases. We have a way to directly communicate that it’s not a far-off thing. It’s happening to your friends and family right now.”

Hospitals, medical schools, and public health programs are stepping up to educate the next generation of doctors as well as veteran medical workers on one of the most widespread, insidious health threats of our time – climate change – and specific ways it could affect their patients.

Although climate change may seem to many Americans like a distant threat, Marilyn Howarth, MD, a pediatrician in Philadelphia, is trying to make sure physicians are better prepared to treat a growing number of health problems associated with global warming.

“There isn’t a lot of education for pediatricians and internists on environmental health issues. It has not been a standard part of education in medical school or residency training,” Dr. Howarth, deputy director of the new Philadelphia Regional Center for Children’s Environmental Health, said. “With increasing attention on our climate, we really recognize there’s a real gap in physician knowledge, both in pediatric and adult care.”

Scientists have found that climate change can alter just about every system within the human body. Studies show that more extreme weather events, such as heat waves, thunderstorms, and floods, can worsen asthma and produce more pollen and mold, triggering debilitating respiratory problems.

According to the American Lung Association, ultrafine particles of air pollution can be inhaled and then travel throughout the bloodstream, wreaking havoc on organs and increasing risk of heart attack and stroke. Various types of air pollution also cause changes to the climate by trapping heat in the atmosphere, which leads to problems such as rising sea levels and extreme weather. Plus, in a new study published in Nature, scientists warn that warming climates are forcing animals to migrate to different areas, raising the risk that new infectious diseases will hop from animals – such as bats – to humans, a process called “zoonotic spillover” that many researchers believe is responsible for the COVID-19 pandemic.
 

The Philadelphia Regional Center for Children’s Environmental Health

One of the latest initiatives aimed at disseminating information about children’s health to health care providers is the Philadelphia Regional Center for Children’s Environmental Health, part of Children’s Hospital of Philadelphia and Penn Medicine. CHOP and Penn Medicine are jointly funding this center’s work, which will include educating health care providers on how to better screen for climate-caused health risks and treat related conditions, such as lead poisoning and asthma.

Outreach will focus on providers who treat patients with illnesses that researchers have linked to climate change, Dr. Howarth said. The center will offer clinicians access to seminars and webinars, along with online resources to help doctors treat environmental illnesses. For example, doctors at CHOP’s Poison Control Center are developing a toolkit for physicians to treat patients with elevated levels of lead in the blood. Scientists have linked extreme weather events related to climate change to flooding that pushes metals away from river banks where they were previously contained, allowing them to more easily contaminate homes, soils, and yards.

The initiative builds on CHOP’s Community Asthma Prevention Program (CAPP), which was launched in 1997 by Tyra Bryant-Stephens, MD, its current medical director. CAPP deploys community health workers into homes armed with supplies and tips for managing asthma. The new center will use similar tactics to provide education and resources to patients. The goal is to reach as many at-risk local children as possible.
 

Future generation of doctors fuel growth in climate change education

Lisa Doggett, MD, cofounder and president of the board of directors of Texas Physicians for Social Responsibility, announced in March that the University of Texas at Austin, Baylor College of Medicine, Houston, and the University of Texas Southwestern in Dallas have all decided to begin offering a course on environmental threats. Emory’s new curriculum has become more comprehensive every year since its start – thanks in part to the input of students like Ms. Manivannan. Faculty members tasked her with approving the new additions to the curriculum on how climate affects health, which in 2019 had consisted of a few slides about issues such as extreme heat exposure and air pollution and their effects on childbirth outcomes.

Material on climate change has now been woven into 13 courses. It is discussed at length in relation to pulmonology, cardiology, and gastropulmonology, for example, said Rebecca Philipsborn, MD, MPA, FAAP, faculty lead for the environmental and health curriculum at Emory.

The curriculum has only been incorporated into Emory’s program for the past 2 years. Dr. Philipsborn said the school plans to expand it to the clinical years to help trainees learn to treat conditions such as pediatric asthma.

“In the past few years, there has been so much momentum, and part of that is a testament to already seeing effects of climate change and how they affect delivery of health care,” she said.

At least one medical journal has recently ramped up its efforts to educate physicians on the links between health issues and climate change. Editors of Family Practice, from Oxford University Press, have announced that they plan to publish a special Climate Crisis and Primary Health Care issue in September.

Of course, not all climate initiatives in medicine are new. A select few have existed for decades.

But only now are physicians widely seeing the links between health and environment, according to Aaron Bernstein, MD, MPH, interim director of the Center for Climate, Health, and the Global Environment (C-CHANGE) at Harvard School of Public Health, Boston.

C-CHANGE, founded in 1996, was the first center in the world to focus on the health effects of environmental change.

“It’s taken 20 years, but what we’re seeing, I think, is the fruits of education,” Dr. Bernstein said. “There’s clearly a wave building here, and I think it really started with education and people younger than the people in charge calling them into account.”

Like the Philadelphia center, Harvard’s program conducts research on climate and health and educates people from high schoolers to health care veterans. Dr. Bernstein helps lead Climate MD, a program that aims to prepare health care workers for climate crises. The Climate MD team has published several articles in peer-reviewed journals on how to better treat patients struggling with environmental health problems. For example, an article on mapping patients in hurricane zones helped shed light on how systems can identify climate-vulnerable patients using public data.

They also developed a tool to help pediatricians provide “climate-informed primary care” – guidance on how to assess whether children are at risk of any harmful environmental exposures, a feature that is not part of standard pediatric visits.

Like the other programs, Climate MD uses community outreach to treat as many local patients as possible. Staff work with providers at more than 100 health clinics, particularly in areas where climate change disproportionately affects residents.

The next major step is to bring some of this into clinical practice, Dr. Bernstein said. In February 2020, C-CHANGE held its first symposium to address that issue.

“The key is to understand climate issues from a provider’s perspective,” he said. “Then those issues can really be brought to the bedside.”

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

Madhu Manivannan, a third-year medical student at Emory University, Atlanta, is on the vanguard of a new approach to clinical education. Ms. Manivannan, copresident of Emory Medical Students for Climate Action, was in the first class of Emory’s medical students to experience the birth of a refined curriculum – lobbied for and partially created by students themselves. The new course of study addresses the myriad ways climate affects health: from air pollution and its effects on the lungs and cardiovascular system to heat-related kidney disease.

“We have known that climate has affected health for decades,” Ms. Manivannan said in a recent interview. “The narrative used to be that icebergs were melting and in 2050 polar bears would be extinct. The piece that’s different now is people are linking climate to increases in asthma and various diseases. We have a way to directly communicate that it’s not a far-off thing. It’s happening to your friends and family right now.”

Hospitals, medical schools, and public health programs are stepping up to educate the next generation of doctors as well as veteran medical workers on one of the most widespread, insidious health threats of our time – climate change – and specific ways it could affect their patients.

Although climate change may seem to many Americans like a distant threat, Marilyn Howarth, MD, a pediatrician in Philadelphia, is trying to make sure physicians are better prepared to treat a growing number of health problems associated with global warming.

“There isn’t a lot of education for pediatricians and internists on environmental health issues. It has not been a standard part of education in medical school or residency training,” Dr. Howarth, deputy director of the new Philadelphia Regional Center for Children’s Environmental Health, said. “With increasing attention on our climate, we really recognize there’s a real gap in physician knowledge, both in pediatric and adult care.”

Scientists have found that climate change can alter just about every system within the human body. Studies show that more extreme weather events, such as heat waves, thunderstorms, and floods, can worsen asthma and produce more pollen and mold, triggering debilitating respiratory problems.

According to the American Lung Association, ultrafine particles of air pollution can be inhaled and then travel throughout the bloodstream, wreaking havoc on organs and increasing risk of heart attack and stroke. Various types of air pollution also cause changes to the climate by trapping heat in the atmosphere, which leads to problems such as rising sea levels and extreme weather. Plus, in a new study published in Nature, scientists warn that warming climates are forcing animals to migrate to different areas, raising the risk that new infectious diseases will hop from animals – such as bats – to humans, a process called “zoonotic spillover” that many researchers believe is responsible for the COVID-19 pandemic.
 

The Philadelphia Regional Center for Children’s Environmental Health

One of the latest initiatives aimed at disseminating information about children’s health to health care providers is the Philadelphia Regional Center for Children’s Environmental Health, part of Children’s Hospital of Philadelphia and Penn Medicine. CHOP and Penn Medicine are jointly funding this center’s work, which will include educating health care providers on how to better screen for climate-caused health risks and treat related conditions, such as lead poisoning and asthma.

Outreach will focus on providers who treat patients with illnesses that researchers have linked to climate change, Dr. Howarth said. The center will offer clinicians access to seminars and webinars, along with online resources to help doctors treat environmental illnesses. For example, doctors at CHOP’s Poison Control Center are developing a toolkit for physicians to treat patients with elevated levels of lead in the blood. Scientists have linked extreme weather events related to climate change to flooding that pushes metals away from river banks where they were previously contained, allowing them to more easily contaminate homes, soils, and yards.

The initiative builds on CHOP’s Community Asthma Prevention Program (CAPP), which was launched in 1997 by Tyra Bryant-Stephens, MD, its current medical director. CAPP deploys community health workers into homes armed with supplies and tips for managing asthma. The new center will use similar tactics to provide education and resources to patients. The goal is to reach as many at-risk local children as possible.
 

Future generation of doctors fuel growth in climate change education

Lisa Doggett, MD, cofounder and president of the board of directors of Texas Physicians for Social Responsibility, announced in March that the University of Texas at Austin, Baylor College of Medicine, Houston, and the University of Texas Southwestern in Dallas have all decided to begin offering a course on environmental threats. Emory’s new curriculum has become more comprehensive every year since its start – thanks in part to the input of students like Ms. Manivannan. Faculty members tasked her with approving the new additions to the curriculum on how climate affects health, which in 2019 had consisted of a few slides about issues such as extreme heat exposure and air pollution and their effects on childbirth outcomes.

Material on climate change has now been woven into 13 courses. It is discussed at length in relation to pulmonology, cardiology, and gastropulmonology, for example, said Rebecca Philipsborn, MD, MPA, FAAP, faculty lead for the environmental and health curriculum at Emory.

The curriculum has only been incorporated into Emory’s program for the past 2 years. Dr. Philipsborn said the school plans to expand it to the clinical years to help trainees learn to treat conditions such as pediatric asthma.

“In the past few years, there has been so much momentum, and part of that is a testament to already seeing effects of climate change and how they affect delivery of health care,” she said.

At least one medical journal has recently ramped up its efforts to educate physicians on the links between health issues and climate change. Editors of Family Practice, from Oxford University Press, have announced that they plan to publish a special Climate Crisis and Primary Health Care issue in September.

Of course, not all climate initiatives in medicine are new. A select few have existed for decades.

But only now are physicians widely seeing the links between health and environment, according to Aaron Bernstein, MD, MPH, interim director of the Center for Climate, Health, and the Global Environment (C-CHANGE) at Harvard School of Public Health, Boston.

C-CHANGE, founded in 1996, was the first center in the world to focus on the health effects of environmental change.

“It’s taken 20 years, but what we’re seeing, I think, is the fruits of education,” Dr. Bernstein said. “There’s clearly a wave building here, and I think it really started with education and people younger than the people in charge calling them into account.”

Like the Philadelphia center, Harvard’s program conducts research on climate and health and educates people from high schoolers to health care veterans. Dr. Bernstein helps lead Climate MD, a program that aims to prepare health care workers for climate crises. The Climate MD team has published several articles in peer-reviewed journals on how to better treat patients struggling with environmental health problems. For example, an article on mapping patients in hurricane zones helped shed light on how systems can identify climate-vulnerable patients using public data.

They also developed a tool to help pediatricians provide “climate-informed primary care” – guidance on how to assess whether children are at risk of any harmful environmental exposures, a feature that is not part of standard pediatric visits.

Like the other programs, Climate MD uses community outreach to treat as many local patients as possible. Staff work with providers at more than 100 health clinics, particularly in areas where climate change disproportionately affects residents.

The next major step is to bring some of this into clinical practice, Dr. Bernstein said. In February 2020, C-CHANGE held its first symposium to address that issue.

“The key is to understand climate issues from a provider’s perspective,” he said. “Then those issues can really be brought to the bedside.”

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

A 63-YEAR-OLD SOUTHEAST ASIAN WOMAN presented with early satiety, mild swelling of her lower extremities, and several months of progressive shortness of breath that had become severe (provoked by activities of daily living). She had a history of longstanding, rate-controlled atrial fibrillation on oral anticoagulation. She also had a history of mitral valve stenosis that was treated 30 years earlier with mechanical valve replacement. The patient had previously been treated out of state and prior records were not available.

Chest radiography (CXR) was performed as part of the initial work-up (FIGURE 1) and demonstrated a substantially enlarged cardiac silhouette spanning the entire width of the chest without significant pleural effusion or evidence of airspace disease. Suspecting a primary cardiac pathology in this patient, we explored clinical findings of heart failure with transthoracic echocardiography.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

 

 

Dx: Severe tricuspid valve regurgitation secondary to rheumatic heart disease

A transthoracic echocardiogram (FIGURE 2A) revealed cardiomegaly with massive right atrial enlargement; a color-flow Doppler (FIGURE 2B) revealed severe tricuspid regurgitation, reduced right ventricular systolic function, and preserved left ventricular systolic function. All of these findings pointed to the diagnosis of rheumatic heart disease (RHD), especially in the context of prior mitral valve stenosis.

RHD affects more than 33 million people annually and remains a significant problem globally.¹ It’s associated with a relatively poor prognosis, especially if heart failure is present (as it was in this case).^2,3 Although the mitral and aortic valves are most commonly affected, approximately 34% of patients will develop tricuspid regurgitation.⁴ Right-side cardiac manifestations of RHD may lead to clinical heart failure with chronic venous congestion and, ultimately, cirrhosis.

Suspect RHD when encountering a new murmur in a patient with prior history of acute rheumatic fever, especially if they are living in or are from a country where rheumatic disease is endemic (most of the developing world).

The diagnosis is confirmed when echocardiographic findings demonstrate characteristic pathologic valve changes (eg, thickening of the anterior mitral valve leaflet, especially the leaflet tips and subvalvular apparatus).

The differential for an enlarged cardiac silhouette

The differential diagnosis for an enlarged cardiac silhouette on CXR includes cardiomegaly (as in this case), pericardial effusion, or a thoracic mass (either mediastinal or pericardial). Imaging artifact from patient orientation may also yield the appearance of an enlarged cardiac silhouette. Distinguishing between these entities may be accomplished by incorporating the history with selection of more definitive imaging (eg, echocardiogram or computed tomography).

Continue to: Management depends on the severity and symptoms

 

 

Management depends on the severity and symptoms

Percutaneous or surgical intervention may be required with RHD, depending on the clinical scenario. If the patient also has atrial fibrillation, medical management includes oral anticoagulation (with a vitamin K antagonist). Additionally, secondary prophylaxis with long-term antibiotics (directed against recurrent group A Streptococcus infection) is recommended for RHD patients with mitral stenosis.⁵ If the patient in this case had engaged in more regular cardiology follow-up, the progression of her tricuspid regurgitation may have been mitigated by surgical intervention and aggressive medical management (although the progression of RHD can eclipse standard treatments).⁵

In this case, a liver biopsy was pursued for prognostication. Unfortunately, the biopsy demonstrated cirrhosis with perisinusoidal fibrosis suggesting an advanced, end-stage clinical state. This diagnosis precluded the patient’s eligibility for advanced therapies such as right ventricular assist device implantation or cardiac transplantation. Surgical intervention (repair or replacement) was also deemed likely to be futile due to right ventricular dilatation and systolic dysfunction in the context of antecedent left-side valve intervention.

The patient elected to pursue palliative care and died at home several months later. In the years since this case occurred, less invasive tricuspid valve interventions have been explored, offering promise of amelioration of such cases in the future.⁶

A 63-YEAR-OLD SOUTHEAST ASIAN WOMAN presented with early satiety, mild swelling of her lower extremities, and several months of progressive shortness of breath that had become severe (provoked by activities of daily living). She had a history of longstanding, rate-controlled atrial fibrillation on oral anticoagulation. She also had a history of mitral valve stenosis that was treated 30 years earlier with mechanical valve replacement. The patient had previously been treated out of state and prior records were not available.

Chest radiography (CXR) was performed as part of the initial work-up (FIGURE 1) and demonstrated a substantially enlarged cardiac silhouette spanning the entire width of the chest without significant pleural effusion or evidence of airspace disease. Suspecting a primary cardiac pathology in this patient, we explored clinical findings of heart failure with transthoracic echocardiography.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

 

 

Dx: Severe tricuspid valve regurgitation secondary to rheumatic heart disease

A transthoracic echocardiogram (FIGURE 2A) revealed cardiomegaly with massive right atrial enlargement; a color-flow Doppler (FIGURE 2B) revealed severe tricuspid regurgitation, reduced right ventricular systolic function, and preserved left ventricular systolic function. All of these findings pointed to the diagnosis of rheumatic heart disease (RHD), especially in the context of prior mitral valve stenosis.

RHD affects more than 33 million people annually and remains a significant problem globally.¹ It’s associated with a relatively poor prognosis, especially if heart failure is present (as it was in this case).^2,3 Although the mitral and aortic valves are most commonly affected, approximately 34% of patients will develop tricuspid regurgitation.⁴ Right-side cardiac manifestations of RHD may lead to clinical heart failure with chronic venous congestion and, ultimately, cirrhosis.

Suspect RHD when encountering a new murmur in a patient with prior history of acute rheumatic fever, especially if they are living in or are from a country where rheumatic disease is endemic (most of the developing world).

The diagnosis is confirmed when echocardiographic findings demonstrate characteristic pathologic valve changes (eg, thickening of the anterior mitral valve leaflet, especially the leaflet tips and subvalvular apparatus).

The differential for an enlarged cardiac silhouette

The differential diagnosis for an enlarged cardiac silhouette on CXR includes cardiomegaly (as in this case), pericardial effusion, or a thoracic mass (either mediastinal or pericardial). Imaging artifact from patient orientation may also yield the appearance of an enlarged cardiac silhouette. Distinguishing between these entities may be accomplished by incorporating the history with selection of more definitive imaging (eg, echocardiogram or computed tomography).

Continue to: Management depends on the severity and symptoms

 

 

Management depends on the severity and symptoms

Percutaneous or surgical intervention may be required with RHD, depending on the clinical scenario. If the patient also has atrial fibrillation, medical management includes oral anticoagulation (with a vitamin K antagonist). Additionally, secondary prophylaxis with long-term antibiotics (directed against recurrent group A Streptococcus infection) is recommended for RHD patients with mitral stenosis.⁵ If the patient in this case had engaged in more regular cardiology follow-up, the progression of her tricuspid regurgitation may have been mitigated by surgical intervention and aggressive medical management (although the progression of RHD can eclipse standard treatments).⁵

In this case, a liver biopsy was pursued for prognostication. Unfortunately, the biopsy demonstrated cirrhosis with perisinusoidal fibrosis suggesting an advanced, end-stage clinical state. This diagnosis precluded the patient’s eligibility for advanced therapies such as right ventricular assist device implantation or cardiac transplantation. Surgical intervention (repair or replacement) was also deemed likely to be futile due to right ventricular dilatation and systolic dysfunction in the context of antecedent left-side valve intervention.

The patient elected to pursue palliative care and died at home several months later. In the years since this case occurred, less invasive tricuspid valve interventions have been explored, offering promise of amelioration of such cases in the future.⁶

A 63-YEAR-OLD SOUTHEAST ASIAN WOMAN presented with early satiety, mild swelling of her lower extremities, and several months of progressive shortness of breath that had become severe (provoked by activities of daily living). She had a history of longstanding, rate-controlled atrial fibrillation on oral anticoagulation. She also had a history of mitral valve stenosis that was treated 30 years earlier with mechanical valve replacement. The patient had previously been treated out of state and prior records were not available.

Chest radiography (CXR) was performed as part of the initial work-up (FIGURE 1) and demonstrated a substantially enlarged cardiac silhouette spanning the entire width of the chest without significant pleural effusion or evidence of airspace disease. Suspecting a primary cardiac pathology in this patient, we explored clinical findings of heart failure with transthoracic echocardiography.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

 

 

Dx: Severe tricuspid valve regurgitation secondary to rheumatic heart disease

A transthoracic echocardiogram (FIGURE 2A) revealed cardiomegaly with massive right atrial enlargement; a color-flow Doppler (FIGURE 2B) revealed severe tricuspid regurgitation, reduced right ventricular systolic function, and preserved left ventricular systolic function. All of these findings pointed to the diagnosis of rheumatic heart disease (RHD), especially in the context of prior mitral valve stenosis.

RHD affects more than 33 million people annually and remains a significant problem globally.¹ It’s associated with a relatively poor prognosis, especially if heart failure is present (as it was in this case).^2,3 Although the mitral and aortic valves are most commonly affected, approximately 34% of patients will develop tricuspid regurgitation.⁴ Right-side cardiac manifestations of RHD may lead to clinical heart failure with chronic venous congestion and, ultimately, cirrhosis.

Suspect RHD when encountering a new murmur in a patient with prior history of acute rheumatic fever, especially if they are living in or are from a country where rheumatic disease is endemic (most of the developing world).

The diagnosis is confirmed when echocardiographic findings demonstrate characteristic pathologic valve changes (eg, thickening of the anterior mitral valve leaflet, especially the leaflet tips and subvalvular apparatus).

The differential for an enlarged cardiac silhouette

The differential diagnosis for an enlarged cardiac silhouette on CXR includes cardiomegaly (as in this case), pericardial effusion, or a thoracic mass (either mediastinal or pericardial). Imaging artifact from patient orientation may also yield the appearance of an enlarged cardiac silhouette. Distinguishing between these entities may be accomplished by incorporating the history with selection of more definitive imaging (eg, echocardiogram or computed tomography).

Continue to: Management depends on the severity and symptoms

 

 

Management depends on the severity and symptoms

Percutaneous or surgical intervention may be required with RHD, depending on the clinical scenario. If the patient also has atrial fibrillation, medical management includes oral anticoagulation (with a vitamin K antagonist). Additionally, secondary prophylaxis with long-term antibiotics (directed against recurrent group A Streptococcus infection) is recommended for RHD patients with mitral stenosis.⁵ If the patient in this case had engaged in more regular cardiology follow-up, the progression of her tricuspid regurgitation may have been mitigated by surgical intervention and aggressive medical management (although the progression of RHD can eclipse standard treatments).⁵

In this case, a liver biopsy was pursued for prognostication. Unfortunately, the biopsy demonstrated cirrhosis with perisinusoidal fibrosis suggesting an advanced, end-stage clinical state. This diagnosis precluded the patient’s eligibility for advanced therapies such as right ventricular assist device implantation or cardiac transplantation. Surgical intervention (repair or replacement) was also deemed likely to be futile due to right ventricular dilatation and systolic dysfunction in the context of antecedent left-side valve intervention.

The patient elected to pursue palliative care and died at home several months later. In the years since this case occurred, less invasive tricuspid valve interventions have been explored, offering promise of amelioration of such cases in the future.⁶

I believe that the most important recommendation from the American Heart Association in recent years is to confirm office blood pressure (BP) readings with repeated home BP measurements, for both diagnosis and management of hypertension. Office BPs are notoriously inaccurate, because it is exceedingly difficult to measure BP properly in a busy office setting. Even when measured correctly, the office BP does not accurately reflect a person’s BP throughout the day, which is the best predictor of cardiovascular damage from hypertension.

Office BPs are notoriously inaccurate, because it is exceedingly difficult to measure BP properly in a busy office setting.

Among the problems with relying on office BP readings:We would treat many people for hypertension who are not hypertensive, because 15% to 30% of those with elevated office BP readings have “white-coat” hypertension, which does not require medication.¹ White-coat hypertension can only be diagnosed with home BP readings or 24-hour ambulatory BP monitoring.

We would miss the diagnosis of hypertension in patients with “masked” hypertension—that is, people who have normal BP in the office but elevated ambulatory BP. It is estimated that 12% of US adults have masked hypertension.²

We would overtreat some patients who have hypertension and undertreat others, since office BP measurements can underestimate BP by an average of 24/14 mm Hg and overestimate BP by an average of 33/23 mm Hg.³

In this issue of JFP, Spaulding and colleagues⁴ provide an extensive summary of the research that supports the recommendation for home BP measurements. Here are 3 key takeaways:

1. Use an automated BP monitor to measure BP in the office. Automated BP monitors that take repeated BPs over the course of about 5 minutes and average the results provide a much better estimate of 24-hour BP. It is worth the extra time and may be the only basis for making decisions about medications if a patient is unwilling or unable to take home BP readings.
2. Provide training to patients who are willing to monitor their BP at home. Explain how to take their BP properly and instruct them to record at least 12 readings over the course of 3 days prior to office visits.
3. Recommend patients use a validated BP monitor that uses the brachial artery for measurement, not the wrist (visit www.stridebp.org/bp-monitors and choose “Home”).

I believe that the most important recommendation from the American Heart Association in recent years is to confirm office blood pressure (BP) readings with repeated home BP measurements, for both diagnosis and management of hypertension. Office BPs are notoriously inaccurate, because it is exceedingly difficult to measure BP properly in a busy office setting. Even when measured correctly, the office BP does not accurately reflect a person’s BP throughout the day, which is the best predictor of cardiovascular damage from hypertension.

Office BPs are notoriously inaccurate, because it is exceedingly difficult to measure BP properly in a busy office setting.

Among the problems with relying on office BP readings:We would treat many people for hypertension who are not hypertensive, because 15% to 30% of those with elevated office BP readings have “white-coat” hypertension, which does not require medication.¹ White-coat hypertension can only be diagnosed with home BP readings or 24-hour ambulatory BP monitoring.

We would miss the diagnosis of hypertension in patients with “masked” hypertension—that is, people who have normal BP in the office but elevated ambulatory BP. It is estimated that 12% of US adults have masked hypertension.²

We would overtreat some patients who have hypertension and undertreat others, since office BP measurements can underestimate BP by an average of 24/14 mm Hg and overestimate BP by an average of 33/23 mm Hg.³

In this issue of JFP, Spaulding and colleagues⁴ provide an extensive summary of the research that supports the recommendation for home BP measurements. Here are 3 key takeaways:

1. Use an automated BP monitor to measure BP in the office. Automated BP monitors that take repeated BPs over the course of about 5 minutes and average the results provide a much better estimate of 24-hour BP. It is worth the extra time and may be the only basis for making decisions about medications if a patient is unwilling or unable to take home BP readings.
2. Provide training to patients who are willing to monitor their BP at home. Explain how to take their BP properly and instruct them to record at least 12 readings over the course of 3 days prior to office visits.
3. Recommend patients use a validated BP monitor that uses the brachial artery for measurement, not the wrist (visit www.stridebp.org/bp-monitors and choose “Home”).

I believe that the most important recommendation from the American Heart Association in recent years is to confirm office blood pressure (BP) readings with repeated home BP measurements, for both diagnosis and management of hypertension. Office BPs are notoriously inaccurate, because it is exceedingly difficult to measure BP properly in a busy office setting. Even when measured correctly, the office BP does not accurately reflect a person’s BP throughout the day, which is the best predictor of cardiovascular damage from hypertension.

Office BPs are notoriously inaccurate, because it is exceedingly difficult to measure BP properly in a busy office setting.

Among the problems with relying on office BP readings:We would treat many people for hypertension who are not hypertensive, because 15% to 30% of those with elevated office BP readings have “white-coat” hypertension, which does not require medication.¹ White-coat hypertension can only be diagnosed with home BP readings or 24-hour ambulatory BP monitoring.

We would miss the diagnosis of hypertension in patients with “masked” hypertension—that is, people who have normal BP in the office but elevated ambulatory BP. It is estimated that 12% of US adults have masked hypertension.²

We would overtreat some patients who have hypertension and undertreat others, since office BP measurements can underestimate BP by an average of 24/14 mm Hg and overestimate BP by an average of 33/23 mm Hg.³

In this issue of JFP, Spaulding and colleagues⁴ provide an extensive summary of the research that supports the recommendation for home BP measurements. Here are 3 key takeaways:

1. Use an automated BP monitor to measure BP in the office. Automated BP monitors that take repeated BPs over the course of about 5 minutes and average the results provide a much better estimate of 24-hour BP. It is worth the extra time and may be the only basis for making decisions about medications if a patient is unwilling or unable to take home BP readings.
2. Provide training to patients who are willing to monitor their BP at home. Explain how to take their BP properly and instruct them to record at least 12 readings over the course of 3 days prior to office visits.
3. Recommend patients use a validated BP monitor that uses the brachial artery for measurement, not the wrist (visit www.stridebp.org/bp-monitors and choose “Home”).

In 2021, the US Preventive Services Task Force (USPSTF) considered 13 topics and made a total of 23 recommendations. They reviewed only 1 new topic. The other 12 were updates of topics previously addressed; no changes were made in 9 of them. In 3, the recommended age of screening or the criteria for screening were expanded. This Practice Alert will review the recommendations made and highlight new recommendations and any changes to previous ones. All complete recommendation statements, rationales, clinical considerations, and evidence reports can be found on the USPSTF website at https://uspreventiveservicestaskforce.org/uspstf/home.¹

Dental caries in children

Dental caries affect about 23% of children between the ages of 2 and 5 years and are associated with multiple adverse social outcomes and medical conditions.² The best way to prevent tooth decay, other than regular brushing with fluoride toothpaste, is to drink water with recommended amounts of fluoride (≥ 0.6 parts fluoride per million parts water).² The USPSTF reaffirmed its recommendation from 2014 that stated when a local water supply lacks sufficient fluoride, primary care clinicians should prescribe oral supplementation for infants and children in the form of fluoride drops starting at age 6 months. The dosage of fluoride depends on patient age and fluoride concentration in the local water (TABLE 1³). The USPSTF also recommends applying topical fluoride as 5% sodium fluoride varnish, every 6 months, starting when the primary teeth erupt.²

BREAKING NEWS At press time, the USPSTF issued its final recommendation on the use of aspirin for primary prevention of cardiovascular disease; see https:// bit.ly/3vklQEe for details.

In addition to fluoride supplements and topical varnish, should clinicians perform screening examinations looking for dental caries? The USPSTF feels there is not enough evidence to assess this practice and gives it an “I” rating (insufficient evidence).

Preventive interventions in pregnancy 

In 2021, the USPSTF assessed 3 topics related to pregnancy and prenatal care.

Screening for gestational diabetes. The USPSTF gave a “B” recommendation for screening at 24 weeks of pregnancy or after, but an “I” statement for screening prior to 24 weeks.⁴ Screening can involve a 1-step or 2-step protocol.

The 2-step protocol is most commonly used in the United States. It involves first measuring serum glucose after a nonfasting 50-g oral glucose challenge; if the resulting level is high, the second step is a 75- or 100-g oral glucose tolerance test lasting 3 hours. The 1-step protocol involves measuring a fasting glucose level, followed by a 75-g oral glucose challenge with glucose levels measured at 1 and 2 hours.

Healthy weight gain in pregnancy. This was the only new topic the USPSTF assessed last year. The resulting recommendation is to offer pregnant women behavioral counseling to promote healthy weight gain and to prevent excessive weight gain in pregnancy. The recommended weight gain depends on the mother’s prepregnancy weight status: 28 to 40 lbs if the mother is underweight; 25 to 35 lbs if she is not under- or overweight; 15 to 25 lbs if she is overweight; and 11 to 20 lbs if she is obese.⁵ Healthy weight gain contributes to preventing gestational diabetes, emergency cesarean sections, and infant macrosomia.

Continue to: Low-dose aspirin

Low-dose aspirin. Reaffirming a recommendation from 2014, the USPSTF advises low-dose aspirin (81 mg/d) starting after 12 weeks’ gestation for all pregnant women who are at high risk for preeclampsia. TABLE 2⁶ lists high- and moderate-risk conditions for preeclampsia and the recommendation for the use of low-dose aspirin.

Sexually transmitted infections

Screening for both chlamydia and gonorrhea in sexually active females through age 24 years was given a “B” recommendation, reaffirming the 2014 recommendation.⁷ Screening for these 2 sexually transmitted infections (STIs) is also recommended for women 25 years and older who are at increased risk of STIs. Risk is defined as having a new sex partner, more than 1 sex partner, a sex partner who has other sex partners, or a sex partner who has an STI; not using condoms consistently; having a previous STI; exchanging sex for money or drugs; or having a history of incarceration.

Screen for both infections simultaneously using a nucleic acid amplification test, testing all sites of sexual exposure. Urine testing can replace cervical, vaginal, and urethral testing. Those found to be positive for either STI should be treated according to the most recent treatment guidelines from the Centers for Disease Control and Prevention (CDC). And sexual partners should be advised to undergo testing.^8,9

The USPSTF could not find evidence for the benefits and harms of screening for STIs in men. Remember that screening applies to those who are asymptomatic. Male sex partners of those found to be infected should be tested, as should those who show any signs or symptoms of an STI. A recent Practice Alert described the most current CDC guidance for diagnosing and treating STIs.⁹

Type 2 diabetes and prediabetes

Screening for type 2 diabetes (T2D) and prediabetes is now recommended for adults ages 35 to 70 years who are overweight or obese.¹⁰ The age to start screening has been lowered to 35 years from the previous recommendation in 2015, which recommended starting at age 40. In addition, the recommendation states that patients with prediabetes should be referred for preventive interventions. It is important that referral is included in the statement because the Affordable Care Act mandates that USPSTF “A” and “B” recommendations must be covered by commercial health insurance with no copay or deductible.

Continue to: Screening can be conducted...

Screening can be conducted using a fasting plasma glucose or A1C level, or with an oral glucose tolerance test. Interventions that can prevent or delay the onset of T2D in those with prediabetes include lifestyle interventions that focus on diet and physical activity, and the use of metformin (although metformin has not been approved for this by the US Food and Drug Administration).

Changes to cancer screening recommendations

In 2021, the USPSTF reviewed and modified its recommendations on screening for 2 types of cancer: colorectal and lung.

For colorectal cancer, the age at which to start screening was lowered from 50 years to 45 years.¹¹ Screening at this earlier age is a “B” recommendation, because, while there is benefit from screening, it is less than for older age groups. Screening individuals ages 50 to 75 years remains an “A” recommendation, and for those ages 76 to 85 years it remains a “C” recommendation. A “C” recommendation means that the overall benefits are small but some individuals might benefit based on their overall health and prior screening results. In its clinical considerations, the USPSTF recommends against screening in those ages 85 and older but, curiously, does not list it as a “D” recommendation. The screening methods and recommended screening intervals for each appear in TABLE 3.¹¹

For lung cancer, annual screening using low-dose computed tomography (CT) was first recommended by the USPSTF in 2013 for adults ages 55 to 80 years with a 30-pack-year smoking history. Screening could stop once 15 years had passed since smoking cessation. In 2021, the USPSTF lowered the age to initiate screening to 50 years, and the smoking history threshold to 20 pack-years.¹² If these recommendations are followed, a current smoker who does not quit smoking could possibly receive 30 annual CT scans. The recommendation does state that screening should stop once a person develops a health condition that significantly affects life expectancy or ability to have lung surgery.

For primary prevention of lung cancer and other chronic diseases through smoking cessation, the USPSTF also reassessed its 2015 recommendations. It reaffirmed the “A” recommendation to ask adults about tobacco use and, for tobacco users, to recommend cessation and provide behavioral therapy and approved pharmacotherapy.¹³ The recommendation differed for pregnant adults in that the USPSTF is unsure about the potential harms of pharmacotherapy in pregnancy and gives that an “I” statement.¹³ An additional “I” statement was made about the use of electronic cigarettes for smoking cessation; the USPSTF recommends using behavioral and pharmacotherapy interventions with proven effectiveness and safety instead.

Continue to: 4 additional recommendation updates with no changes

4 additional recommendation updates with no changes

Screening for high blood pressure in adults ages 18 years and older continues to receive an “A” recommendation.¹⁴ Importantly, the recommendation states that confirmation of high blood pressure should be made in an out-of-­office setting before initiating treatment. Screening for vitamin D deficiency in adults and hearing loss in older adults both continue with “I” statements,^15,16 and screening for asymptomatic carotid artery stenosis continues to receive a “D” recommendation.¹⁷ The implications of the vitamin D “I” statement were discussed in a previous Practice Alert.¹⁸

Continuing value of the USPSTF

The USPSTF continues to set the gold standard for assessment of preventive interventions, and its decisions affect first-dollar coverage by commercial health insurance. The reaffirmation of past recommendations demonstrates the value of adhering to rigorous evidence-based methods (if they are done correctly, they rarely must be markedly changed). And the updating of screening criteria shows the need to constantly review the evolving evidence for current recommendations. Once again, however, funding and staffing limitations allowed the USPSTF to assess only 1 new topic. A listing of all the 2021 recommendations is in TABLE 4.¹

In 2021, the US Preventive Services Task Force (USPSTF) considered 13 topics and made a total of 23 recommendations. They reviewed only 1 new topic. The other 12 were updates of topics previously addressed; no changes were made in 9 of them. In 3, the recommended age of screening or the criteria for screening were expanded. This Practice Alert will review the recommendations made and highlight new recommendations and any changes to previous ones. All complete recommendation statements, rationales, clinical considerations, and evidence reports can be found on the USPSTF website at https://uspreventiveservicestaskforce.org/uspstf/home.¹

Dental caries in children

Dental caries affect about 23% of children between the ages of 2 and 5 years and are associated with multiple adverse social outcomes and medical conditions.² The best way to prevent tooth decay, other than regular brushing with fluoride toothpaste, is to drink water with recommended amounts of fluoride (≥ 0.6 parts fluoride per million parts water).² The USPSTF reaffirmed its recommendation from 2014 that stated when a local water supply lacks sufficient fluoride, primary care clinicians should prescribe oral supplementation for infants and children in the form of fluoride drops starting at age 6 months. The dosage of fluoride depends on patient age and fluoride concentration in the local water (TABLE 1³). The USPSTF also recommends applying topical fluoride as 5% sodium fluoride varnish, every 6 months, starting when the primary teeth erupt.²

BREAKING NEWS At press time, the USPSTF issued its final recommendation on the use of aspirin for primary prevention of cardiovascular disease; see https:// bit.ly/3vklQEe for details.

In addition to fluoride supplements and topical varnish, should clinicians perform screening examinations looking for dental caries? The USPSTF feels there is not enough evidence to assess this practice and gives it an “I” rating (insufficient evidence).

Preventive interventions in pregnancy 

In 2021, the USPSTF assessed 3 topics related to pregnancy and prenatal care.

Screening for gestational diabetes. The USPSTF gave a “B” recommendation for screening at 24 weeks of pregnancy or after, but an “I” statement for screening prior to 24 weeks.⁴ Screening can involve a 1-step or 2-step protocol.

The 2-step protocol is most commonly used in the United States. It involves first measuring serum glucose after a nonfasting 50-g oral glucose challenge; if the resulting level is high, the second step is a 75- or 100-g oral glucose tolerance test lasting 3 hours. The 1-step protocol involves measuring a fasting glucose level, followed by a 75-g oral glucose challenge with glucose levels measured at 1 and 2 hours.

Healthy weight gain in pregnancy. This was the only new topic the USPSTF assessed last year. The resulting recommendation is to offer pregnant women behavioral counseling to promote healthy weight gain and to prevent excessive weight gain in pregnancy. The recommended weight gain depends on the mother’s prepregnancy weight status: 28 to 40 lbs if the mother is underweight; 25 to 35 lbs if she is not under- or overweight; 15 to 25 lbs if she is overweight; and 11 to 20 lbs if she is obese.⁵ Healthy weight gain contributes to preventing gestational diabetes, emergency cesarean sections, and infant macrosomia.

Continue to: Low-dose aspirin

Low-dose aspirin. Reaffirming a recommendation from 2014, the USPSTF advises low-dose aspirin (81 mg/d) starting after 12 weeks’ gestation for all pregnant women who are at high risk for preeclampsia. TABLE 2⁶ lists high- and moderate-risk conditions for preeclampsia and the recommendation for the use of low-dose aspirin.

Sexually transmitted infections

Screening for both chlamydia and gonorrhea in sexually active females through age 24 years was given a “B” recommendation, reaffirming the 2014 recommendation.⁷ Screening for these 2 sexually transmitted infections (STIs) is also recommended for women 25 years and older who are at increased risk of STIs. Risk is defined as having a new sex partner, more than 1 sex partner, a sex partner who has other sex partners, or a sex partner who has an STI; not using condoms consistently; having a previous STI; exchanging sex for money or drugs; or having a history of incarceration.

Screen for both infections simultaneously using a nucleic acid amplification test, testing all sites of sexual exposure. Urine testing can replace cervical, vaginal, and urethral testing. Those found to be positive for either STI should be treated according to the most recent treatment guidelines from the Centers for Disease Control and Prevention (CDC). And sexual partners should be advised to undergo testing.^8,9

The USPSTF could not find evidence for the benefits and harms of screening for STIs in men. Remember that screening applies to those who are asymptomatic. Male sex partners of those found to be infected should be tested, as should those who show any signs or symptoms of an STI. A recent Practice Alert described the most current CDC guidance for diagnosing and treating STIs.⁹

Type 2 diabetes and prediabetes

Screening for type 2 diabetes (T2D) and prediabetes is now recommended for adults ages 35 to 70 years who are overweight or obese.¹⁰ The age to start screening has been lowered to 35 years from the previous recommendation in 2015, which recommended starting at age 40. In addition, the recommendation states that patients with prediabetes should be referred for preventive interventions. It is important that referral is included in the statement because the Affordable Care Act mandates that USPSTF “A” and “B” recommendations must be covered by commercial health insurance with no copay or deductible.

Continue to: Screening can be conducted...

Screening can be conducted using a fasting plasma glucose or A1C level, or with an oral glucose tolerance test. Interventions that can prevent or delay the onset of T2D in those with prediabetes include lifestyle interventions that focus on diet and physical activity, and the use of metformin (although metformin has not been approved for this by the US Food and Drug Administration).

Changes to cancer screening recommendations

In 2021, the USPSTF reviewed and modified its recommendations on screening for 2 types of cancer: colorectal and lung.

For colorectal cancer, the age at which to start screening was lowered from 50 years to 45 years.¹¹ Screening at this earlier age is a “B” recommendation, because, while there is benefit from screening, it is less than for older age groups. Screening individuals ages 50 to 75 years remains an “A” recommendation, and for those ages 76 to 85 years it remains a “C” recommendation. A “C” recommendation means that the overall benefits are small but some individuals might benefit based on their overall health and prior screening results. In its clinical considerations, the USPSTF recommends against screening in those ages 85 and older but, curiously, does not list it as a “D” recommendation. The screening methods and recommended screening intervals for each appear in TABLE 3.¹¹

For lung cancer, annual screening using low-dose computed tomography (CT) was first recommended by the USPSTF in 2013 for adults ages 55 to 80 years with a 30-pack-year smoking history. Screening could stop once 15 years had passed since smoking cessation. In 2021, the USPSTF lowered the age to initiate screening to 50 years, and the smoking history threshold to 20 pack-years.¹² If these recommendations are followed, a current smoker who does not quit smoking could possibly receive 30 annual CT scans. The recommendation does state that screening should stop once a person develops a health condition that significantly affects life expectancy or ability to have lung surgery.

For primary prevention of lung cancer and other chronic diseases through smoking cessation, the USPSTF also reassessed its 2015 recommendations. It reaffirmed the “A” recommendation to ask adults about tobacco use and, for tobacco users, to recommend cessation and provide behavioral therapy and approved pharmacotherapy.¹³ The recommendation differed for pregnant adults in that the USPSTF is unsure about the potential harms of pharmacotherapy in pregnancy and gives that an “I” statement.¹³ An additional “I” statement was made about the use of electronic cigarettes for smoking cessation; the USPSTF recommends using behavioral and pharmacotherapy interventions with proven effectiveness and safety instead.

Continue to: 4 additional recommendation updates with no changes

4 additional recommendation updates with no changes

Screening for high blood pressure in adults ages 18 years and older continues to receive an “A” recommendation.¹⁴ Importantly, the recommendation states that confirmation of high blood pressure should be made in an out-of-­office setting before initiating treatment. Screening for vitamin D deficiency in adults and hearing loss in older adults both continue with “I” statements,^15,16 and screening for asymptomatic carotid artery stenosis continues to receive a “D” recommendation.¹⁷ The implications of the vitamin D “I” statement were discussed in a previous Practice Alert.¹⁸

Continuing value of the USPSTF

The USPSTF continues to set the gold standard for assessment of preventive interventions, and its decisions affect first-dollar coverage by commercial health insurance. The reaffirmation of past recommendations demonstrates the value of adhering to rigorous evidence-based methods (if they are done correctly, they rarely must be markedly changed). And the updating of screening criteria shows the need to constantly review the evolving evidence for current recommendations. Once again, however, funding and staffing limitations allowed the USPSTF to assess only 1 new topic. A listing of all the 2021 recommendations is in TABLE 4.¹

In 2021, the US Preventive Services Task Force (USPSTF) considered 13 topics and made a total of 23 recommendations. They reviewed only 1 new topic. The other 12 were updates of topics previously addressed; no changes were made in 9 of them. In 3, the recommended age of screening or the criteria for screening were expanded. This Practice Alert will review the recommendations made and highlight new recommendations and any changes to previous ones. All complete recommendation statements, rationales, clinical considerations, and evidence reports can be found on the USPSTF website at https://uspreventiveservicestaskforce.org/uspstf/home.¹

Dental caries in children

Dental caries affect about 23% of children between the ages of 2 and 5 years and are associated with multiple adverse social outcomes and medical conditions.² The best way to prevent tooth decay, other than regular brushing with fluoride toothpaste, is to drink water with recommended amounts of fluoride (≥ 0.6 parts fluoride per million parts water).² The USPSTF reaffirmed its recommendation from 2014 that stated when a local water supply lacks sufficient fluoride, primary care clinicians should prescribe oral supplementation for infants and children in the form of fluoride drops starting at age 6 months. The dosage of fluoride depends on patient age and fluoride concentration in the local water (TABLE 1³). The USPSTF also recommends applying topical fluoride as 5% sodium fluoride varnish, every 6 months, starting when the primary teeth erupt.²

BREAKING NEWS At press time, the USPSTF issued its final recommendation on the use of aspirin for primary prevention of cardiovascular disease; see https:// bit.ly/3vklQEe for details.

In addition to fluoride supplements and topical varnish, should clinicians perform screening examinations looking for dental caries? The USPSTF feels there is not enough evidence to assess this practice and gives it an “I” rating (insufficient evidence).

Preventive interventions in pregnancy 

In 2021, the USPSTF assessed 3 topics related to pregnancy and prenatal care.

Screening for gestational diabetes. The USPSTF gave a “B” recommendation for screening at 24 weeks of pregnancy or after, but an “I” statement for screening prior to 24 weeks.⁴ Screening can involve a 1-step or 2-step protocol.

The 2-step protocol is most commonly used in the United States. It involves first measuring serum glucose after a nonfasting 50-g oral glucose challenge; if the resulting level is high, the second step is a 75- or 100-g oral glucose tolerance test lasting 3 hours. The 1-step protocol involves measuring a fasting glucose level, followed by a 75-g oral glucose challenge with glucose levels measured at 1 and 2 hours.

Healthy weight gain in pregnancy. This was the only new topic the USPSTF assessed last year. The resulting recommendation is to offer pregnant women behavioral counseling to promote healthy weight gain and to prevent excessive weight gain in pregnancy. The recommended weight gain depends on the mother’s prepregnancy weight status: 28 to 40 lbs if the mother is underweight; 25 to 35 lbs if she is not under- or overweight; 15 to 25 lbs if she is overweight; and 11 to 20 lbs if she is obese.⁵ Healthy weight gain contributes to preventing gestational diabetes, emergency cesarean sections, and infant macrosomia.

Continue to: Low-dose aspirin

Low-dose aspirin. Reaffirming a recommendation from 2014, the USPSTF advises low-dose aspirin (81 mg/d) starting after 12 weeks’ gestation for all pregnant women who are at high risk for preeclampsia. TABLE 2⁶ lists high- and moderate-risk conditions for preeclampsia and the recommendation for the use of low-dose aspirin.

Sexually transmitted infections

Screening for both chlamydia and gonorrhea in sexually active females through age 24 years was given a “B” recommendation, reaffirming the 2014 recommendation.⁷ Screening for these 2 sexually transmitted infections (STIs) is also recommended for women 25 years and older who are at increased risk of STIs. Risk is defined as having a new sex partner, more than 1 sex partner, a sex partner who has other sex partners, or a sex partner who has an STI; not using condoms consistently; having a previous STI; exchanging sex for money or drugs; or having a history of incarceration.

Screen for both infections simultaneously using a nucleic acid amplification test, testing all sites of sexual exposure. Urine testing can replace cervical, vaginal, and urethral testing. Those found to be positive for either STI should be treated according to the most recent treatment guidelines from the Centers for Disease Control and Prevention (CDC). And sexual partners should be advised to undergo testing.^8,9

The USPSTF could not find evidence for the benefits and harms of screening for STIs in men. Remember that screening applies to those who are asymptomatic. Male sex partners of those found to be infected should be tested, as should those who show any signs or symptoms of an STI. A recent Practice Alert described the most current CDC guidance for diagnosing and treating STIs.⁹

Type 2 diabetes and prediabetes

Screening for type 2 diabetes (T2D) and prediabetes is now recommended for adults ages 35 to 70 years who are overweight or obese.¹⁰ The age to start screening has been lowered to 35 years from the previous recommendation in 2015, which recommended starting at age 40. In addition, the recommendation states that patients with prediabetes should be referred for preventive interventions. It is important that referral is included in the statement because the Affordable Care Act mandates that USPSTF “A” and “B” recommendations must be covered by commercial health insurance with no copay or deductible.

Continue to: Screening can be conducted...

Screening can be conducted using a fasting plasma glucose or A1C level, or with an oral glucose tolerance test. Interventions that can prevent or delay the onset of T2D in those with prediabetes include lifestyle interventions that focus on diet and physical activity, and the use of metformin (although metformin has not been approved for this by the US Food and Drug Administration).

Changes to cancer screening recommendations

In 2021, the USPSTF reviewed and modified its recommendations on screening for 2 types of cancer: colorectal and lung.

For colorectal cancer, the age at which to start screening was lowered from 50 years to 45 years.¹¹ Screening at this earlier age is a “B” recommendation, because, while there is benefit from screening, it is less than for older age groups. Screening individuals ages 50 to 75 years remains an “A” recommendation, and for those ages 76 to 85 years it remains a “C” recommendation. A “C” recommendation means that the overall benefits are small but some individuals might benefit based on their overall health and prior screening results. In its clinical considerations, the USPSTF recommends against screening in those ages 85 and older but, curiously, does not list it as a “D” recommendation. The screening methods and recommended screening intervals for each appear in TABLE 3.¹¹

For lung cancer, annual screening using low-dose computed tomography (CT) was first recommended by the USPSTF in 2013 for adults ages 55 to 80 years with a 30-pack-year smoking history. Screening could stop once 15 years had passed since smoking cessation. In 2021, the USPSTF lowered the age to initiate screening to 50 years, and the smoking history threshold to 20 pack-years.¹² If these recommendations are followed, a current smoker who does not quit smoking could possibly receive 30 annual CT scans. The recommendation does state that screening should stop once a person develops a health condition that significantly affects life expectancy or ability to have lung surgery.

For primary prevention of lung cancer and other chronic diseases through smoking cessation, the USPSTF also reassessed its 2015 recommendations. It reaffirmed the “A” recommendation to ask adults about tobacco use and, for tobacco users, to recommend cessation and provide behavioral therapy and approved pharmacotherapy.¹³ The recommendation differed for pregnant adults in that the USPSTF is unsure about the potential harms of pharmacotherapy in pregnancy and gives that an “I” statement.¹³ An additional “I” statement was made about the use of electronic cigarettes for smoking cessation; the USPSTF recommends using behavioral and pharmacotherapy interventions with proven effectiveness and safety instead.

Continue to: 4 additional recommendation updates with no changes

4 additional recommendation updates with no changes

Screening for high blood pressure in adults ages 18 years and older continues to receive an “A” recommendation.¹⁴ Importantly, the recommendation states that confirmation of high blood pressure should be made in an out-of-­office setting before initiating treatment. Screening for vitamin D deficiency in adults and hearing loss in older adults both continue with “I” statements,^15,16 and screening for asymptomatic carotid artery stenosis continues to receive a “D” recommendation.¹⁷ The implications of the vitamin D “I” statement were discussed in a previous Practice Alert.¹⁸

Continuing value of the USPSTF

The USPSTF continues to set the gold standard for assessment of preventive interventions, and its decisions affect first-dollar coverage by commercial health insurance. The reaffirmation of past recommendations demonstrates the value of adhering to rigorous evidence-based methods (if they are done correctly, they rarely must be markedly changed). And the updating of screening criteria shows the need to constantly review the evolving evidence for current recommendations. Once again, however, funding and staffing limitations allowed the USPSTF to assess only 1 new topic. A listing of all the 2021 recommendations is in TABLE 4.¹

Normal blood pressure (BP) is defined as systolic BP (SBP) < 120 mm Hg and diastolic BP (DBP) < 80 mm Hg.¹ The thresholds for hypertension (HTN) are shown in TABLE 1.¹ These thresholds must be met on at least 2 separate occasions to merit a diagnosis of HTN.¹

Given the high prevalence of HTN and its associated comorbidities, the US Preventive Services Task Force (USPSTF) recently reaffirmed its recommendation that every adult be screened for HTN, regardless of risk factors.² Patients 40 years of age and older and those with risk factors (obesity, family history of HTN, diabetes) should have their BP checked at least annually. Individuals ages 18 to 39 years without risk factors who are initially normotensive should be rescreened within 3 to 5 years.²

Patients are most commonly screened for HTN in the outpatient setting. However, office BP measurements may be inaccurate and are of limited diagnostic utility when taken as a single reading.^1,3,4 As will be described later, office BP measurements are subject to multiple sources of error that can result in a mean underestimation of 24  mm Hg to a mean overestimation of 33 mm Hg for SBP, and a mean underestimation of 14  mm Hg to a mean overestimation of 23 mm Hg for DBP.⁴

Differences to this degree between true BP and measured BP can have important implications for the diagnosis, surveillance, and management of HTN. To diminish this potential for error, the American Heart Association HTN guideline and USPSTF recommendation advise clinicians to obtain out-of-office BP measurements to confirm a diagnosis of HTN before initiating treatment.^1,2 The preferred methods for out-of-office BP assessment are home BP monitoring (HBPM) and 24-hour ambulatory BP monitoring (ABPM).

Limitations of office BP measurement

Multiple sources of error can lead to wide variability in the measurement of office BP, whether taken via the traditional sphygmomanometer auscultatory approach or with an oscillometric monitor.^1,4 Measurement error can be patient related (eg, talking during the reading, or eating or using tobacco prior to measurement), device related (eg, device has not been calibrated or validated), or procedure related (eg, miscuffing, improper patient positioning).

Although use of validated oscillometric monitors eliminates some sources of error such as terminal digit bias, rapid cuff deflation, and missed Korotkoff sounds, their use does not eliminate other sources of error. For example, a patient’s use of tobacco 30 to 60 minutes prior to measurement can raise SBP by 2.8 to 25 mm Hg and DBP 2 to 18 mm Hg.⁴ Having a full bladder can elevate SBP by 4.2 to 33 mm Hg and DBP by 2.8 to 18.5 mm Hg.⁴ If the patient is talking during measurement, is crossing one leg over the opposite knee, or has an unsupported arm below the level of the heart, SBP and DBP can rise, respectively, by an estimated mean 2 to 23 mm Hg and 2 to 14 mm Hg.⁴

Although many sources of BP measurement error can be reduced or eliminated through standardization of technique across office staff, some sources of inaccuracy will persist. Even if all variables are optimized, relying solely on office BP monitoring will still misclassify BP phenotypes, which require out-of-office BP assessments.^1,3FIGURE 1 reviews key tips for maximizing the accuracy of BP measurement, regardless of where the measurement is done.

Continue to: Automated office BP

Automated office BP (AOBP) lessens some of the limitations inherent with the traditional sphygmomanometer auscultatory and single-measurement oscillometric devices. AOBP combines oscillometric technology with the capacity to record multiple BP readings within a single activation, thereby providing an average of these readings.¹ The total time required for AOBP is 4 to 6 minutes, including a brief rest period before the measurement starts. Studies have reported comparable readings between staff-attended and unattended AOBP, which is an encouraging way to eliminate some measurement error (eg, talking with the patient) and to improve efficiency.^5,6

Waiting several minutes per patient to record BP may not be practical in a busy office setting and may require an alteration of workflow. There is a paucity of literature evaluating practice realities, which makes it difficult to know how many patients are getting their BP checked in this manner. Several studies have shown that BP measured with AOBP is closer to awake out-of-office BP as measured with ABPM (discussed in a bit),^5-8 largely through mitigation of white-coat effect. Canada now recommends AOBP as the preferred method for diagnosing HTN and monitoring BP.⁹

Home blood pressure monitoring

HBPM refers to individuals measuring their own BP at home. It is important to remember this definition, as the term is sometimes applied to a patient’s BP measured at home by an observer or to an individual taking their own BP outside of the home (kiosk, pharmacy, at work). The short-term reproducibility of mean BP with HBPM is high. The test-retest correlations of HBPM range from 0.70 to 0.84 mm Hg for mean SBP, and from 0.57 to 0.83 mm Hg for mean DBP.^10-13 In contrast to 24-hour ABPM, HBPM is better tolerated, cheaper, and more widely available.^14,15

There is strong evidence that HBPM adds value over and above office measurements in predicting end-organ damage and cardiovascular disease (CVD) outcomes, and it has a stronger relationship with CVD risk than office BP.¹ Compared with office BP measurement, HBPM is a better predictor of echocardiographic left ventricular mass index, urinary albumin-to-creatinine ratio, proteinuria, silent cerebrovascular disease, nonfatal cardiovascular outcomes, cardiovascular mortality, and all-cause mortality.^15,16 There is no strong evidence demonstrating the superiority of HBPM over ABPM, or vice versa, for predicting CVD events or mortality.¹⁷ Both ABPM and HBPM have important roles in out-of-office monitoring (FIGURE 2³).

Clinical indications for HBPM

HBPM can facilitate diagnosis of white-coat HTN or effect (if already on BP-lowering medication) as well as masked uncontrolled HTN and masked HTN. Importantly, masked HTN is associated with nearly the same risk of target organ damage and cardiovascular events as sustained HTN. In one meta-analysis the overall adjusted hazard ratio for CVD events was 2.00 (95% CI, 1.58-2.52) for masked HTN and 2.28 (95% CI, 1.87-2.78) for sustained HTN, compared with normotensive individuals.¹⁸ Other studies support these results, demonstrating that masked HTN confers risk similar to sustained HTN.^19,20

Even treated subjects with masked uncontrolled HTN (normal office and high home BP) have higher CVD risk, likely due to undertreatment given lower BP in the office setting. Among 1451 treated patients in a large cohort study who were followed for a median of 8.3 years, CVD was higher in those with masked uncontrolled HTN (adjusted hazard ratio = 1.76; 95% CI, 1.23-2.53) compared to treated controlled patients (normal office and home BP).²¹

Home BP monitoring can reveal masked hypertension, which confers risk for endorgan damage similar to that of sustained hypertension.

HBPM also can be used to monitor BP levels over time, to increase patient involvement in chronic disease management, and to improve adherence with medications. Since 2008, several meta-analyses have been published showing improved BP control when HBPM is combined with other interventions and patient education.^22-25 Particularly relevant in the age of increased telehealth, several meta-analyses demonstrate improvement in BP control when HBPM is combined with web- or phone-based support, systematic medication titration, patient education, and provider counseling.^22-25 A comprehensive systematic review found HBPM with this kind of ongoing support (compared with usual care) led to clinic SBP reductions of 3.2 mm Hg (95% CI, 1.6-4.9) at 12 months.²²

Continue to: HBPM nuts and bolts

 

 

HBPM nuts and bolts

When using HBPM to obtain a BP average either for confirming a diagnosis or assessing HTN control, patients should be instructed to record their BP measurements twice in the morning and twice at night for a minimum of 3 days (ie, 12 readings).^26,27 For each monitoring period, both SBP and DBP readings should be recorded, although protocols differ as to whether to discard the initial reading of each day, or the entire first day of readings.^26-29 Consecutive days of monitoring are preferred, although nonconsecutive days also are likely to provide valid data. Once BP stabilizes, monitoring 1 to 3 days a week is likely sufficient.

Most guidelines cite a mean BP of ≥ 135/85 mm Hg as the indication of high BP on HBPM.^1,28,29 This value corresponds to an office BP average of 140/90 mm Hg. TABLE 2¹ shows the comparison of home, ambulatory, and office BP thresholds.

Device selection and validation

As with any BP device, validation and proper technique are important. Recommend only upper-arm cuff devices that have passed validation protocols.³⁰ To eliminate the burden on patients to accurately record and store their BP readings, and to eliminate this step as a source of bias, additionally recommend devices with built-in memory. Although easy-to-use wrist and finger monitors have become popular, there are important limitations in terms of accurate positioning and a lack of validated protocols.^31,32

The brachial artery is still the recommended measurement location, unless otherwise precluded due to arm size (the largest size for most validated upper-arm cuffs is 42 cm), patient discomfort, medical contraindication (eg, lymphedema), or immobility (eg, due to injury). Arm size limitation is particularly important as obesity rates continue to rise. Data from the National Health and Nutrition Examination Survey indicate that 52% of men and 38% of women with HTN need a different cuff size than the US standard.³³ If the brachial artery is not an option, there are no definitive data to recommend finger over wrist devices, as both are limited by lack of validated protocols.

The website www.stridebp.org maintains a current list of validated and preferred BP devices, and is supported by the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League. There are more than 4000 devices on the global market, but only 8% have been validated according to StrideBP.

Advances in HBPM that offset previous limitations

The usefulness of HBPM depends on patient factors such as a commitment to monitoring, applying standardized technique, and accurately recording measurements. Discuss these matters with patients before recommending HBPM. Until recently, HBPM devices could not measure BP during sleep. However, a device that assesses BP during sleep has now come on the US market, with preliminary data suggesting the BP measurements are similar to those obtained with ABPM.³⁴ Advances in device memory and data storage and increased availability of electronic health record connection continue to improve the standardization and reliability of HBPM. In fact, there is a growing list of electronic health portals that can be synced with apps for direct transfer of HBPM data.

Ambulatory blood pressure monitoring

ABPM involves wearing a small device connected to an arm BP cuff that measures BP at pre-programmed intervals over a 24-hour period, during sleep and wakefulness. ABPM is the standard against which HBPM and office BP are compared.^1-3

Continue to: Clinical indications for ABPM

 

 

Clinical indications for ABPM

Compared with office-based BP measurements, ABPM has a stronger positive correlation with clinical CVD outcomes and HTN-related organ damage.¹ ABPM has the advantage of being able to provide a large number of measurements over the course of a patient’s daily activities, including sleep. It is useful to evaluate for a wide spectrum of hypertensive or hypotensive patterns, including nocturnal, postprandial, and drug-related patterns. ABPM also is used to assess for white-coat HTN and masked HTN.¹

Among these BP phenotypes, an estimated 15% to 30% of adults in the United States exhibit white-coat HTN.¹ Most evidence suggests that white-coat HTN confers similar cardiovascular risk as normotension, and it therefore does not require treatment.³⁵ Confirming this diagnosis saves the individual and the health care system the cost of unnecessary diagnosis and treatment.

A home monitor that assesses sleep BP is available in some US markets, with data showing its sleep measurements are similar to those obtained with ambulatory BP monitoring.

One cost-effectiveness study using ABPM for annual screening with subsequent treatment for those confirmed to be hypertensive found that ABPM reduced treatment-years by correctly identifying white-coat HTN, and also delayed treatment for those who would eventually develop HTN with advancing age.³⁶ The estimates in savings were 3% to 14% for total cost of care for hypertension and 10% to 23% reduction in treatment days.³⁶ An Australian study showed similar cost reductions.³⁷ A more recent analysis demonstrated that compared with clinic BP measurement alone, incorporation of ABPM is associated with lifetime cost-savings ranging from $77 to $5013, depending on the age and sex of the patients modeled.³⁸

ABPM can also be used to rule out white-coat effect in patients being evaluated for resistant HTN. Several studies demonstrate that among patients with apparent resistant HTN, approximately one-third have controlled BP when assessed by ABPM.^39-41 Thus, it is recommended to conduct an out-of-office BP assessment in patients with apparent resistant HTN prior to adding another medication.⁴¹Twelve percent of US adults have masked HTN.⁴² As described earlier, these patients, unrecognized without out-of-office BP assessment, are twice as likely to experience a CVD event compared with normotensive patients.^1,42,43

ABPM nuts and bolts

ABPM devices are typically worn for 24 hours and with little interruption to daily routines. Prior to BP capture, the device will alert the patient to ensure the patient’s arm can be held still while the BP measurement is being captured.⁴⁴ At the completion of 24 hours, specific software uses the stored data to calculate the BP and heart rate averages, as well as minimums and maximums throughout the monitoring period. Clinical decision-making should be driven by the average BP measurements during times of sleep and wakefulness.^1,14,44FIGURE 3 is an example of output from an ABPM session. TABLE 3^1,44 offers a comparison of HBPM and ABPM.

Limitations of ABPM

While ABPM has been designed to be almost effortless to use, some may find it inconvenient to wear. The repeated cuff inflations can cause discomfort or bruising, and the device can interfere with sleep.⁴⁵ Inconsistent or incorrect wear of ABPM can diminish the quality of BP measurements, which can potentially affect interpretation and subsequent clinical decision-making. Therefore, consider the likelihood of correct and complete usage before ordering ABPM for your patient. Such deliberation is particularly relevant when there is concern for BP phenotypes such as nocturnal nondipping (failure of BP to fall appropriately during sleep) and postprandial HTN and hypotension.

Conduct out-of-office BP assessment of apparent resistant hypertension before adding another medication.

Trained personnel are needed to oversee coordination of the ABPM service within the clinic and to educate patients about proper wear. Additionally, ABPM has not been widely used in US clinical practices to date, in part because this diagnostic strategy is not favorably reimbursed. Based on geographic region, Medicare currently pays between $56 and $122 per 24-hour ABPM session, and only for suspected white-coat HTN.³⁸ Discrepancies remain between commercial and Medicaid/Medicare coverage.⁴⁴

Continue to: Other modes of monitoring BP

Other modes of monitoring BP

The COVID pandemic has changed health care in many ways, including the frequency of in-person visits. As clinics come to rely more on virtual visits and telehealth, accurate monitoring of out-of-office BP has become more important. Kiosks and smart technology offer the opportunity to supplement traditional in-office BP readings. Kiosks are commonly found in pharmacies and grocery stores. These stations facilitate BP monitoring, as long as the device is appropriately validated and calibrated. Unfortunately, most kiosks have only one cuff size that is too small for many US adults, and some do not have a back support.^46,47 Additionally, despite US Food and Drug Administration clearance, many kiosks do not have validated protocols, and the reproducibility of kiosk-measured BP is questionable.^46,47

Mobile health technology is increasingly being examined as an effective means of providing health information, support, and management in chronic disease. Smartphone technology, wearable sensors, and cuffless BP monitors offer promise for providing BP data in more convenient ways. However, as with kiosk devices, very few of these have been validated, and several have been shown to have poor accuracy compared with oscillometric devices.^48-50 For these reasons, kiosk and smart technology for BP monitoring are not recommended at this time, unless no alternatives are available to the patient.

CORRESPONDENCE
Anthony J. Viera, MD, Department of Family Medicine and Community Health, Duke University School of Medicine, 2200 West Main Street, Suite 400, Durham, NC 27705; ajv18@duke.edu

Normal blood pressure (BP) is defined as systolic BP (SBP) < 120 mm Hg and diastolic BP (DBP) < 80 mm Hg.¹ The thresholds for hypertension (HTN) are shown in TABLE 1.¹ These thresholds must be met on at least 2 separate occasions to merit a diagnosis of HTN.¹

Given the high prevalence of HTN and its associated comorbidities, the US Preventive Services Task Force (USPSTF) recently reaffirmed its recommendation that every adult be screened for HTN, regardless of risk factors.² Patients 40 years of age and older and those with risk factors (obesity, family history of HTN, diabetes) should have their BP checked at least annually. Individuals ages 18 to 39 years without risk factors who are initially normotensive should be rescreened within 3 to 5 years.²

Patients are most commonly screened for HTN in the outpatient setting. However, office BP measurements may be inaccurate and are of limited diagnostic utility when taken as a single reading.^1,3,4 As will be described later, office BP measurements are subject to multiple sources of error that can result in a mean underestimation of 24  mm Hg to a mean overestimation of 33 mm Hg for SBP, and a mean underestimation of 14  mm Hg to a mean overestimation of 23 mm Hg for DBP.⁴

Differences to this degree between true BP and measured BP can have important implications for the diagnosis, surveillance, and management of HTN. To diminish this potential for error, the American Heart Association HTN guideline and USPSTF recommendation advise clinicians to obtain out-of-office BP measurements to confirm a diagnosis of HTN before initiating treatment.^1,2 The preferred methods for out-of-office BP assessment are home BP monitoring (HBPM) and 24-hour ambulatory BP monitoring (ABPM).

Limitations of office BP measurement

Multiple sources of error can lead to wide variability in the measurement of office BP, whether taken via the traditional sphygmomanometer auscultatory approach or with an oscillometric monitor.^1,4 Measurement error can be patient related (eg, talking during the reading, or eating or using tobacco prior to measurement), device related (eg, device has not been calibrated or validated), or procedure related (eg, miscuffing, improper patient positioning).

Although use of validated oscillometric monitors eliminates some sources of error such as terminal digit bias, rapid cuff deflation, and missed Korotkoff sounds, their use does not eliminate other sources of error. For example, a patient’s use of tobacco 30 to 60 minutes prior to measurement can raise SBP by 2.8 to 25 mm Hg and DBP 2 to 18 mm Hg.⁴ Having a full bladder can elevate SBP by 4.2 to 33 mm Hg and DBP by 2.8 to 18.5 mm Hg.⁴ If the patient is talking during measurement, is crossing one leg over the opposite knee, or has an unsupported arm below the level of the heart, SBP and DBP can rise, respectively, by an estimated mean 2 to 23 mm Hg and 2 to 14 mm Hg.⁴

Although many sources of BP measurement error can be reduced or eliminated through standardization of technique across office staff, some sources of inaccuracy will persist. Even if all variables are optimized, relying solely on office BP monitoring will still misclassify BP phenotypes, which require out-of-office BP assessments.^1,3FIGURE 1 reviews key tips for maximizing the accuracy of BP measurement, regardless of where the measurement is done.

Continue to: Automated office BP

Automated office BP (AOBP) lessens some of the limitations inherent with the traditional sphygmomanometer auscultatory and single-measurement oscillometric devices. AOBP combines oscillometric technology with the capacity to record multiple BP readings within a single activation, thereby providing an average of these readings.¹ The total time required for AOBP is 4 to 6 minutes, including a brief rest period before the measurement starts. Studies have reported comparable readings between staff-attended and unattended AOBP, which is an encouraging way to eliminate some measurement error (eg, talking with the patient) and to improve efficiency.^5,6

Waiting several minutes per patient to record BP may not be practical in a busy office setting and may require an alteration of workflow. There is a paucity of literature evaluating practice realities, which makes it difficult to know how many patients are getting their BP checked in this manner. Several studies have shown that BP measured with AOBP is closer to awake out-of-office BP as measured with ABPM (discussed in a bit),^5-8 largely through mitigation of white-coat effect. Canada now recommends AOBP as the preferred method for diagnosing HTN and monitoring BP.⁹

Home blood pressure monitoring

HBPM refers to individuals measuring their own BP at home. It is important to remember this definition, as the term is sometimes applied to a patient’s BP measured at home by an observer or to an individual taking their own BP outside of the home (kiosk, pharmacy, at work). The short-term reproducibility of mean BP with HBPM is high. The test-retest correlations of HBPM range from 0.70 to 0.84 mm Hg for mean SBP, and from 0.57 to 0.83 mm Hg for mean DBP.^10-13 In contrast to 24-hour ABPM, HBPM is better tolerated, cheaper, and more widely available.^14,15

There is strong evidence that HBPM adds value over and above office measurements in predicting end-organ damage and cardiovascular disease (CVD) outcomes, and it has a stronger relationship with CVD risk than office BP.¹ Compared with office BP measurement, HBPM is a better predictor of echocardiographic left ventricular mass index, urinary albumin-to-creatinine ratio, proteinuria, silent cerebrovascular disease, nonfatal cardiovascular outcomes, cardiovascular mortality, and all-cause mortality.^15,16 There is no strong evidence demonstrating the superiority of HBPM over ABPM, or vice versa, for predicting CVD events or mortality.¹⁷ Both ABPM and HBPM have important roles in out-of-office monitoring (FIGURE 2³).

Clinical indications for HBPM

HBPM can facilitate diagnosis of white-coat HTN or effect (if already on BP-lowering medication) as well as masked uncontrolled HTN and masked HTN. Importantly, masked HTN is associated with nearly the same risk of target organ damage and cardiovascular events as sustained HTN. In one meta-analysis the overall adjusted hazard ratio for CVD events was 2.00 (95% CI, 1.58-2.52) for masked HTN and 2.28 (95% CI, 1.87-2.78) for sustained HTN, compared with normotensive individuals.¹⁸ Other studies support these results, demonstrating that masked HTN confers risk similar to sustained HTN.^19,20

Even treated subjects with masked uncontrolled HTN (normal office and high home BP) have higher CVD risk, likely due to undertreatment given lower BP in the office setting. Among 1451 treated patients in a large cohort study who were followed for a median of 8.3 years, CVD was higher in those with masked uncontrolled HTN (adjusted hazard ratio = 1.76; 95% CI, 1.23-2.53) compared to treated controlled patients (normal office and home BP).²¹

Home BP monitoring can reveal masked hypertension, which confers risk for endorgan damage similar to that of sustained hypertension.

HBPM also can be used to monitor BP levels over time, to increase patient involvement in chronic disease management, and to improve adherence with medications. Since 2008, several meta-analyses have been published showing improved BP control when HBPM is combined with other interventions and patient education.^22-25 Particularly relevant in the age of increased telehealth, several meta-analyses demonstrate improvement in BP control when HBPM is combined with web- or phone-based support, systematic medication titration, patient education, and provider counseling.^22-25 A comprehensive systematic review found HBPM with this kind of ongoing support (compared with usual care) led to clinic SBP reductions of 3.2 mm Hg (95% CI, 1.6-4.9) at 12 months.²²

Continue to: HBPM nuts and bolts

 

 

HBPM nuts and bolts

When using HBPM to obtain a BP average either for confirming a diagnosis or assessing HTN control, patients should be instructed to record their BP measurements twice in the morning and twice at night for a minimum of 3 days (ie, 12 readings).^26,27 For each monitoring period, both SBP and DBP readings should be recorded, although protocols differ as to whether to discard the initial reading of each day, or the entire first day of readings.^26-29 Consecutive days of monitoring are preferred, although nonconsecutive days also are likely to provide valid data. Once BP stabilizes, monitoring 1 to 3 days a week is likely sufficient.

Most guidelines cite a mean BP of ≥ 135/85 mm Hg as the indication of high BP on HBPM.^1,28,29 This value corresponds to an office BP average of 140/90 mm Hg. TABLE 2¹ shows the comparison of home, ambulatory, and office BP thresholds.

Device selection and validation

As with any BP device, validation and proper technique are important. Recommend only upper-arm cuff devices that have passed validation protocols.³⁰ To eliminate the burden on patients to accurately record and store their BP readings, and to eliminate this step as a source of bias, additionally recommend devices with built-in memory. Although easy-to-use wrist and finger monitors have become popular, there are important limitations in terms of accurate positioning and a lack of validated protocols.^31,32

The brachial artery is still the recommended measurement location, unless otherwise precluded due to arm size (the largest size for most validated upper-arm cuffs is 42 cm), patient discomfort, medical contraindication (eg, lymphedema), or immobility (eg, due to injury). Arm size limitation is particularly important as obesity rates continue to rise. Data from the National Health and Nutrition Examination Survey indicate that 52% of men and 38% of women with HTN need a different cuff size than the US standard.³³ If the brachial artery is not an option, there are no definitive data to recommend finger over wrist devices, as both are limited by lack of validated protocols.

The website www.stridebp.org maintains a current list of validated and preferred BP devices, and is supported by the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League. There are more than 4000 devices on the global market, but only 8% have been validated according to StrideBP.

Advances in HBPM that offset previous limitations

The usefulness of HBPM depends on patient factors such as a commitment to monitoring, applying standardized technique, and accurately recording measurements. Discuss these matters with patients before recommending HBPM. Until recently, HBPM devices could not measure BP during sleep. However, a device that assesses BP during sleep has now come on the US market, with preliminary data suggesting the BP measurements are similar to those obtained with ABPM.³⁴ Advances in device memory and data storage and increased availability of electronic health record connection continue to improve the standardization and reliability of HBPM. In fact, there is a growing list of electronic health portals that can be synced with apps for direct transfer of HBPM data.

Ambulatory blood pressure monitoring

ABPM involves wearing a small device connected to an arm BP cuff that measures BP at pre-programmed intervals over a 24-hour period, during sleep and wakefulness. ABPM is the standard against which HBPM and office BP are compared.^1-3

Continue to: Clinical indications for ABPM

 

 

Clinical indications for ABPM

Compared with office-based BP measurements, ABPM has a stronger positive correlation with clinical CVD outcomes and HTN-related organ damage.¹ ABPM has the advantage of being able to provide a large number of measurements over the course of a patient’s daily activities, including sleep. It is useful to evaluate for a wide spectrum of hypertensive or hypotensive patterns, including nocturnal, postprandial, and drug-related patterns. ABPM also is used to assess for white-coat HTN and masked HTN.¹

Among these BP phenotypes, an estimated 15% to 30% of adults in the United States exhibit white-coat HTN.¹ Most evidence suggests that white-coat HTN confers similar cardiovascular risk as normotension, and it therefore does not require treatment.³⁵ Confirming this diagnosis saves the individual and the health care system the cost of unnecessary diagnosis and treatment.

A home monitor that assesses sleep BP is available in some US markets, with data showing its sleep measurements are similar to those obtained with ambulatory BP monitoring.

One cost-effectiveness study using ABPM for annual screening with subsequent treatment for those confirmed to be hypertensive found that ABPM reduced treatment-years by correctly identifying white-coat HTN, and also delayed treatment for those who would eventually develop HTN with advancing age.³⁶ The estimates in savings were 3% to 14% for total cost of care for hypertension and 10% to 23% reduction in treatment days.³⁶ An Australian study showed similar cost reductions.³⁷ A more recent analysis demonstrated that compared with clinic BP measurement alone, incorporation of ABPM is associated with lifetime cost-savings ranging from $77 to $5013, depending on the age and sex of the patients modeled.³⁸

ABPM can also be used to rule out white-coat effect in patients being evaluated for resistant HTN. Several studies demonstrate that among patients with apparent resistant HTN, approximately one-third have controlled BP when assessed by ABPM.^39-41 Thus, it is recommended to conduct an out-of-office BP assessment in patients with apparent resistant HTN prior to adding another medication.⁴¹Twelve percent of US adults have masked HTN.⁴² As described earlier, these patients, unrecognized without out-of-office BP assessment, are twice as likely to experience a CVD event compared with normotensive patients.^1,42,43

ABPM nuts and bolts

ABPM devices are typically worn for 24 hours and with little interruption to daily routines. Prior to BP capture, the device will alert the patient to ensure the patient’s arm can be held still while the BP measurement is being captured.⁴⁴ At the completion of 24 hours, specific software uses the stored data to calculate the BP and heart rate averages, as well as minimums and maximums throughout the monitoring period. Clinical decision-making should be driven by the average BP measurements during times of sleep and wakefulness.^1,14,44FIGURE 3 is an example of output from an ABPM session. TABLE 3^1,44 offers a comparison of HBPM and ABPM.

Limitations of ABPM

While ABPM has been designed to be almost effortless to use, some may find it inconvenient to wear. The repeated cuff inflations can cause discomfort or bruising, and the device can interfere with sleep.⁴⁵ Inconsistent or incorrect wear of ABPM can diminish the quality of BP measurements, which can potentially affect interpretation and subsequent clinical decision-making. Therefore, consider the likelihood of correct and complete usage before ordering ABPM for your patient. Such deliberation is particularly relevant when there is concern for BP phenotypes such as nocturnal nondipping (failure of BP to fall appropriately during sleep) and postprandial HTN and hypotension.

Conduct out-of-office BP assessment of apparent resistant hypertension before adding another medication.

Trained personnel are needed to oversee coordination of the ABPM service within the clinic and to educate patients about proper wear. Additionally, ABPM has not been widely used in US clinical practices to date, in part because this diagnostic strategy is not favorably reimbursed. Based on geographic region, Medicare currently pays between $56 and $122 per 24-hour ABPM session, and only for suspected white-coat HTN.³⁸ Discrepancies remain between commercial and Medicaid/Medicare coverage.⁴⁴

Continue to: Other modes of monitoring BP

Other modes of monitoring BP

The COVID pandemic has changed health care in many ways, including the frequency of in-person visits. As clinics come to rely more on virtual visits and telehealth, accurate monitoring of out-of-office BP has become more important. Kiosks and smart technology offer the opportunity to supplement traditional in-office BP readings. Kiosks are commonly found in pharmacies and grocery stores. These stations facilitate BP monitoring, as long as the device is appropriately validated and calibrated. Unfortunately, most kiosks have only one cuff size that is too small for many US adults, and some do not have a back support.^46,47 Additionally, despite US Food and Drug Administration clearance, many kiosks do not have validated protocols, and the reproducibility of kiosk-measured BP is questionable.^46,47

Mobile health technology is increasingly being examined as an effective means of providing health information, support, and management in chronic disease. Smartphone technology, wearable sensors, and cuffless BP monitors offer promise for providing BP data in more convenient ways. However, as with kiosk devices, very few of these have been validated, and several have been shown to have poor accuracy compared with oscillometric devices.^48-50 For these reasons, kiosk and smart technology for BP monitoring are not recommended at this time, unless no alternatives are available to the patient.

CORRESPONDENCE
Anthony J. Viera, MD, Department of Family Medicine and Community Health, Duke University School of Medicine, 2200 West Main Street, Suite 400, Durham, NC 27705; ajv18@duke.edu

Normal blood pressure (BP) is defined as systolic BP (SBP) < 120 mm Hg and diastolic BP (DBP) < 80 mm Hg.¹ The thresholds for hypertension (HTN) are shown in TABLE 1.¹ These thresholds must be met on at least 2 separate occasions to merit a diagnosis of HTN.¹

Given the high prevalence of HTN and its associated comorbidities, the US Preventive Services Task Force (USPSTF) recently reaffirmed its recommendation that every adult be screened for HTN, regardless of risk factors.² Patients 40 years of age and older and those with risk factors (obesity, family history of HTN, diabetes) should have their BP checked at least annually. Individuals ages 18 to 39 years without risk factors who are initially normotensive should be rescreened within 3 to 5 years.²

Patients are most commonly screened for HTN in the outpatient setting. However, office BP measurements may be inaccurate and are of limited diagnostic utility when taken as a single reading.^1,3,4 As will be described later, office BP measurements are subject to multiple sources of error that can result in a mean underestimation of 24  mm Hg to a mean overestimation of 33 mm Hg for SBP, and a mean underestimation of 14  mm Hg to a mean overestimation of 23 mm Hg for DBP.⁴

Differences to this degree between true BP and measured BP can have important implications for the diagnosis, surveillance, and management of HTN. To diminish this potential for error, the American Heart Association HTN guideline and USPSTF recommendation advise clinicians to obtain out-of-office BP measurements to confirm a diagnosis of HTN before initiating treatment.^1,2 The preferred methods for out-of-office BP assessment are home BP monitoring (HBPM) and 24-hour ambulatory BP monitoring (ABPM).

Limitations of office BP measurement

Multiple sources of error can lead to wide variability in the measurement of office BP, whether taken via the traditional sphygmomanometer auscultatory approach or with an oscillometric monitor.^1,4 Measurement error can be patient related (eg, talking during the reading, or eating or using tobacco prior to measurement), device related (eg, device has not been calibrated or validated), or procedure related (eg, miscuffing, improper patient positioning).

Although use of validated oscillometric monitors eliminates some sources of error such as terminal digit bias, rapid cuff deflation, and missed Korotkoff sounds, their use does not eliminate other sources of error. For example, a patient’s use of tobacco 30 to 60 minutes prior to measurement can raise SBP by 2.8 to 25 mm Hg and DBP 2 to 18 mm Hg.⁴ Having a full bladder can elevate SBP by 4.2 to 33 mm Hg and DBP by 2.8 to 18.5 mm Hg.⁴ If the patient is talking during measurement, is crossing one leg over the opposite knee, or has an unsupported arm below the level of the heart, SBP and DBP can rise, respectively, by an estimated mean 2 to 23 mm Hg and 2 to 14 mm Hg.⁴

Although many sources of BP measurement error can be reduced or eliminated through standardization of technique across office staff, some sources of inaccuracy will persist. Even if all variables are optimized, relying solely on office BP monitoring will still misclassify BP phenotypes, which require out-of-office BP assessments.^1,3FIGURE 1 reviews key tips for maximizing the accuracy of BP measurement, regardless of where the measurement is done.

Continue to: Automated office BP

Automated office BP (AOBP) lessens some of the limitations inherent with the traditional sphygmomanometer auscultatory and single-measurement oscillometric devices. AOBP combines oscillometric technology with the capacity to record multiple BP readings within a single activation, thereby providing an average of these readings.¹ The total time required for AOBP is 4 to 6 minutes, including a brief rest period before the measurement starts. Studies have reported comparable readings between staff-attended and unattended AOBP, which is an encouraging way to eliminate some measurement error (eg, talking with the patient) and to improve efficiency.^5,6

Waiting several minutes per patient to record BP may not be practical in a busy office setting and may require an alteration of workflow. There is a paucity of literature evaluating practice realities, which makes it difficult to know how many patients are getting their BP checked in this manner. Several studies have shown that BP measured with AOBP is closer to awake out-of-office BP as measured with ABPM (discussed in a bit),^5-8 largely through mitigation of white-coat effect. Canada now recommends AOBP as the preferred method for diagnosing HTN and monitoring BP.⁹

Home blood pressure monitoring

HBPM refers to individuals measuring their own BP at home. It is important to remember this definition, as the term is sometimes applied to a patient’s BP measured at home by an observer or to an individual taking their own BP outside of the home (kiosk, pharmacy, at work). The short-term reproducibility of mean BP with HBPM is high. The test-retest correlations of HBPM range from 0.70 to 0.84 mm Hg for mean SBP, and from 0.57 to 0.83 mm Hg for mean DBP.^10-13 In contrast to 24-hour ABPM, HBPM is better tolerated, cheaper, and more widely available.^14,15

There is strong evidence that HBPM adds value over and above office measurements in predicting end-organ damage and cardiovascular disease (CVD) outcomes, and it has a stronger relationship with CVD risk than office BP.¹ Compared with office BP measurement, HBPM is a better predictor of echocardiographic left ventricular mass index, urinary albumin-to-creatinine ratio, proteinuria, silent cerebrovascular disease, nonfatal cardiovascular outcomes, cardiovascular mortality, and all-cause mortality.^15,16 There is no strong evidence demonstrating the superiority of HBPM over ABPM, or vice versa, for predicting CVD events or mortality.¹⁷ Both ABPM and HBPM have important roles in out-of-office monitoring (FIGURE 2³).

Clinical indications for HBPM

HBPM can facilitate diagnosis of white-coat HTN or effect (if already on BP-lowering medication) as well as masked uncontrolled HTN and masked HTN. Importantly, masked HTN is associated with nearly the same risk of target organ damage and cardiovascular events as sustained HTN. In one meta-analysis the overall adjusted hazard ratio for CVD events was 2.00 (95% CI, 1.58-2.52) for masked HTN and 2.28 (95% CI, 1.87-2.78) for sustained HTN, compared with normotensive individuals.¹⁸ Other studies support these results, demonstrating that masked HTN confers risk similar to sustained HTN.^19,20

Even treated subjects with masked uncontrolled HTN (normal office and high home BP) have higher CVD risk, likely due to undertreatment given lower BP in the office setting. Among 1451 treated patients in a large cohort study who were followed for a median of 8.3 years, CVD was higher in those with masked uncontrolled HTN (adjusted hazard ratio = 1.76; 95% CI, 1.23-2.53) compared to treated controlled patients (normal office and home BP).²¹

Home BP monitoring can reveal masked hypertension, which confers risk for endorgan damage similar to that of sustained hypertension.

HBPM also can be used to monitor BP levels over time, to increase patient involvement in chronic disease management, and to improve adherence with medications. Since 2008, several meta-analyses have been published showing improved BP control when HBPM is combined with other interventions and patient education.^22-25 Particularly relevant in the age of increased telehealth, several meta-analyses demonstrate improvement in BP control when HBPM is combined with web- or phone-based support, systematic medication titration, patient education, and provider counseling.^22-25 A comprehensive systematic review found HBPM with this kind of ongoing support (compared with usual care) led to clinic SBP reductions of 3.2 mm Hg (95% CI, 1.6-4.9) at 12 months.²²

Continue to: HBPM nuts and bolts

 

 

HBPM nuts and bolts

When using HBPM to obtain a BP average either for confirming a diagnosis or assessing HTN control, patients should be instructed to record their BP measurements twice in the morning and twice at night for a minimum of 3 days (ie, 12 readings).^26,27 For each monitoring period, both SBP and DBP readings should be recorded, although protocols differ as to whether to discard the initial reading of each day, or the entire first day of readings.^26-29 Consecutive days of monitoring are preferred, although nonconsecutive days also are likely to provide valid data. Once BP stabilizes, monitoring 1 to 3 days a week is likely sufficient.

Most guidelines cite a mean BP of ≥ 135/85 mm Hg as the indication of high BP on HBPM.^1,28,29 This value corresponds to an office BP average of 140/90 mm Hg. TABLE 2¹ shows the comparison of home, ambulatory, and office BP thresholds.

Device selection and validation

As with any BP device, validation and proper technique are important. Recommend only upper-arm cuff devices that have passed validation protocols.³⁰ To eliminate the burden on patients to accurately record and store their BP readings, and to eliminate this step as a source of bias, additionally recommend devices with built-in memory. Although easy-to-use wrist and finger monitors have become popular, there are important limitations in terms of accurate positioning and a lack of validated protocols.^31,32

The brachial artery is still the recommended measurement location, unless otherwise precluded due to arm size (the largest size for most validated upper-arm cuffs is 42 cm), patient discomfort, medical contraindication (eg, lymphedema), or immobility (eg, due to injury). Arm size limitation is particularly important as obesity rates continue to rise. Data from the National Health and Nutrition Examination Survey indicate that 52% of men and 38% of women with HTN need a different cuff size than the US standard.³³ If the brachial artery is not an option, there are no definitive data to recommend finger over wrist devices, as both are limited by lack of validated protocols.

The website www.stridebp.org maintains a current list of validated and preferred BP devices, and is supported by the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League. There are more than 4000 devices on the global market, but only 8% have been validated according to StrideBP.

Advances in HBPM that offset previous limitations

The usefulness of HBPM depends on patient factors such as a commitment to monitoring, applying standardized technique, and accurately recording measurements. Discuss these matters with patients before recommending HBPM. Until recently, HBPM devices could not measure BP during sleep. However, a device that assesses BP during sleep has now come on the US market, with preliminary data suggesting the BP measurements are similar to those obtained with ABPM.³⁴ Advances in device memory and data storage and increased availability of electronic health record connection continue to improve the standardization and reliability of HBPM. In fact, there is a growing list of electronic health portals that can be synced with apps for direct transfer of HBPM data.

Ambulatory blood pressure monitoring

ABPM involves wearing a small device connected to an arm BP cuff that measures BP at pre-programmed intervals over a 24-hour period, during sleep and wakefulness. ABPM is the standard against which HBPM and office BP are compared.^1-3

Continue to: Clinical indications for ABPM

 

 

Clinical indications for ABPM

Compared with office-based BP measurements, ABPM has a stronger positive correlation with clinical CVD outcomes and HTN-related organ damage.¹ ABPM has the advantage of being able to provide a large number of measurements over the course of a patient’s daily activities, including sleep. It is useful to evaluate for a wide spectrum of hypertensive or hypotensive patterns, including nocturnal, postprandial, and drug-related patterns. ABPM also is used to assess for white-coat HTN and masked HTN.¹

Among these BP phenotypes, an estimated 15% to 30% of adults in the United States exhibit white-coat HTN.¹ Most evidence suggests that white-coat HTN confers similar cardiovascular risk as normotension, and it therefore does not require treatment.³⁵ Confirming this diagnosis saves the individual and the health care system the cost of unnecessary diagnosis and treatment.

A home monitor that assesses sleep BP is available in some US markets, with data showing its sleep measurements are similar to those obtained with ambulatory BP monitoring.

One cost-effectiveness study using ABPM for annual screening with subsequent treatment for those confirmed to be hypertensive found that ABPM reduced treatment-years by correctly identifying white-coat HTN, and also delayed treatment for those who would eventually develop HTN with advancing age.³⁶ The estimates in savings were 3% to 14% for total cost of care for hypertension and 10% to 23% reduction in treatment days.³⁶ An Australian study showed similar cost reductions.³⁷ A more recent analysis demonstrated that compared with clinic BP measurement alone, incorporation of ABPM is associated with lifetime cost-savings ranging from $77 to $5013, depending on the age and sex of the patients modeled.³⁸

ABPM can also be used to rule out white-coat effect in patients being evaluated for resistant HTN. Several studies demonstrate that among patients with apparent resistant HTN, approximately one-third have controlled BP when assessed by ABPM.^39-41 Thus, it is recommended to conduct an out-of-office BP assessment in patients with apparent resistant HTN prior to adding another medication.⁴¹Twelve percent of US adults have masked HTN.⁴² As described earlier, these patients, unrecognized without out-of-office BP assessment, are twice as likely to experience a CVD event compared with normotensive patients.^1,42,43

ABPM nuts and bolts

ABPM devices are typically worn for 24 hours and with little interruption to daily routines. Prior to BP capture, the device will alert the patient to ensure the patient’s arm can be held still while the BP measurement is being captured.⁴⁴ At the completion of 24 hours, specific software uses the stored data to calculate the BP and heart rate averages, as well as minimums and maximums throughout the monitoring period. Clinical decision-making should be driven by the average BP measurements during times of sleep and wakefulness.^1,14,44FIGURE 3 is an example of output from an ABPM session. TABLE 3^1,44 offers a comparison of HBPM and ABPM.

Limitations of ABPM

While ABPM has been designed to be almost effortless to use, some may find it inconvenient to wear. The repeated cuff inflations can cause discomfort or bruising, and the device can interfere with sleep.⁴⁵ Inconsistent or incorrect wear of ABPM can diminish the quality of BP measurements, which can potentially affect interpretation and subsequent clinical decision-making. Therefore, consider the likelihood of correct and complete usage before ordering ABPM for your patient. Such deliberation is particularly relevant when there is concern for BP phenotypes such as nocturnal nondipping (failure of BP to fall appropriately during sleep) and postprandial HTN and hypotension.

Conduct out-of-office BP assessment of apparent resistant hypertension before adding another medication.

Trained personnel are needed to oversee coordination of the ABPM service within the clinic and to educate patients about proper wear. Additionally, ABPM has not been widely used in US clinical practices to date, in part because this diagnostic strategy is not favorably reimbursed. Based on geographic region, Medicare currently pays between $56 and $122 per 24-hour ABPM session, and only for suspected white-coat HTN.³⁸ Discrepancies remain between commercial and Medicaid/Medicare coverage.⁴⁴

Continue to: Other modes of monitoring BP

Other modes of monitoring BP

The COVID pandemic has changed health care in many ways, including the frequency of in-person visits. As clinics come to rely more on virtual visits and telehealth, accurate monitoring of out-of-office BP has become more important. Kiosks and smart technology offer the opportunity to supplement traditional in-office BP readings. Kiosks are commonly found in pharmacies and grocery stores. These stations facilitate BP monitoring, as long as the device is appropriately validated and calibrated. Unfortunately, most kiosks have only one cuff size that is too small for many US adults, and some do not have a back support.^46,47 Additionally, despite US Food and Drug Administration clearance, many kiosks do not have validated protocols, and the reproducibility of kiosk-measured BP is questionable.^46,47

Mobile health technology is increasingly being examined as an effective means of providing health information, support, and management in chronic disease. Smartphone technology, wearable sensors, and cuffless BP monitors offer promise for providing BP data in more convenient ways. However, as with kiosk devices, very few of these have been validated, and several have been shown to have poor accuracy compared with oscillometric devices.^48-50 For these reasons, kiosk and smart technology for BP monitoring are not recommended at this time, unless no alternatives are available to the patient.

CORRESPONDENCE
Anthony J. Viera, MD, Department of Family Medicine and Community Health, Duke University School of Medicine, 2200 West Main Street, Suite 400, Durham, NC 27705; ajv18@duke.edu

The benefit of endovascular therapy in the treatment of stroke caused by an occlusion of the basilar artery has finally been confirmed in the ATTENTION randomized trial.

The study, conducted in China, showed that endovascular therapy for basilar artery occlusion is associated with higher rates of favorable and independent outcomes, as well as lower overall disability and lower mortality at 90 days, than best medical management alone.

The results were presented by Raul Nogueira, MD, professor of neurology at the University of Pittsburgh School of Medicine, at the European Stroke Organisation Conference (ESOC) 2022, where they were greeted with applause from the audience.

The number needed to treat was just four.

“There were no surprises with secondary endpoints; everything was highly statistically significant,” Dr. Nogueira said.

Specifically, there was a lower rate of overall disability in the shift analysis, with a common odds ratio of 2.8 favoring the intervention.  

Safety results showed an increased risk for symptomatic ICH in the endovascular group (5.3% vs. 0.0%) but, despite that, 90-day mortality was significantly lower in the endovascular group (36.7% vs. 55.3%).

Dr. Nogueira noted a limitation of the study was that it was conducted in China.

“This was a Chinese study and, as Asians are known to have higher rates of intracranial atherosclerotic disease, the overall degree of generalizability of our findings to Western countries needs to be considered,” he commented.

However, subgroup analysis showed no treatment effect modification based on the presence of intracranial atherosclerotic disease, he noted.

Also, the proportion of comorbidities in the ATTENTION trial was similar to that in the BASICS trial, with the same degree of diabetes and atrial fibrillation.

Dr. Nogueira concluded that, in contrast to previous randomized trials of endovascular treatment for basilar artery occlusion, the ATTENTION trial was able to reinforce consecutive enrollment, resulting in a fast recruitment while minimizing crossovers. 

Furthermore, he pointed out that the overall results are consistent with modern era observational studies, large registries, and meta-analysis.

Commenting on the study, Joanna Wardlaw, MD, professor of applied neuroimaging at the University of Edinburgh (Scotland), and chair of the ESOC Planning Group, said: “This is a very important result, since it provides confirmation beyond doubt the benefit of thrombectomy versus medical therapy for basilar artery occlusion stroke up to 12 hours after onset.”

Dr. Wardlaw added: “The trial was large enough to provide clear results and to enable subgroup analyses; no subgroup did not benefit from thrombectomy.”

In a discussion after the presentation, Urs Fischer, MD, chair of the department of neurology at the University Hospital Basel, Switzerland, said he was not surprised by the results of the ATTENTION trial.

“We have been doing thrombectomy in patients with basilar artery occlusion now for 20 years, although trials are extremely important to answer these questions, so now we have some clear evidence,” Dr. Fischer said. “Nevertheless, there are some caveats, as this is an Asian population, but this is a proof of concept, and it is going in the right direction.”

The ATTENTION trial was sponsored by the First Affiliated Hospital of University of Science and Technology of China.

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

The benefit of endovascular therapy in the treatment of stroke caused by an occlusion of the basilar artery has finally been confirmed in the ATTENTION randomized trial.

The study, conducted in China, showed that endovascular therapy for basilar artery occlusion is associated with higher rates of favorable and independent outcomes, as well as lower overall disability and lower mortality at 90 days, than best medical management alone.

The results were presented by Raul Nogueira, MD, professor of neurology at the University of Pittsburgh School of Medicine, at the European Stroke Organisation Conference (ESOC) 2022, where they were greeted with applause from the audience.

The number needed to treat was just four.

“There were no surprises with secondary endpoints; everything was highly statistically significant,” Dr. Nogueira said.

Specifically, there was a lower rate of overall disability in the shift analysis, with a common odds ratio of 2.8 favoring the intervention.  

Safety results showed an increased risk for symptomatic ICH in the endovascular group (5.3% vs. 0.0%) but, despite that, 90-day mortality was significantly lower in the endovascular group (36.7% vs. 55.3%).

Dr. Nogueira noted a limitation of the study was that it was conducted in China.

“This was a Chinese study and, as Asians are known to have higher rates of intracranial atherosclerotic disease, the overall degree of generalizability of our findings to Western countries needs to be considered,” he commented.

However, subgroup analysis showed no treatment effect modification based on the presence of intracranial atherosclerotic disease, he noted.

Also, the proportion of comorbidities in the ATTENTION trial was similar to that in the BASICS trial, with the same degree of diabetes and atrial fibrillation.

Dr. Nogueira concluded that, in contrast to previous randomized trials of endovascular treatment for basilar artery occlusion, the ATTENTION trial was able to reinforce consecutive enrollment, resulting in a fast recruitment while minimizing crossovers. 

Furthermore, he pointed out that the overall results are consistent with modern era observational studies, large registries, and meta-analysis.

Commenting on the study, Joanna Wardlaw, MD, professor of applied neuroimaging at the University of Edinburgh (Scotland), and chair of the ESOC Planning Group, said: “This is a very important result, since it provides confirmation beyond doubt the benefit of thrombectomy versus medical therapy for basilar artery occlusion stroke up to 12 hours after onset.”

Dr. Wardlaw added: “The trial was large enough to provide clear results and to enable subgroup analyses; no subgroup did not benefit from thrombectomy.”

In a discussion after the presentation, Urs Fischer, MD, chair of the department of neurology at the University Hospital Basel, Switzerland, said he was not surprised by the results of the ATTENTION trial.

“We have been doing thrombectomy in patients with basilar artery occlusion now for 20 years, although trials are extremely important to answer these questions, so now we have some clear evidence,” Dr. Fischer said. “Nevertheless, there are some caveats, as this is an Asian population, but this is a proof of concept, and it is going in the right direction.”

The ATTENTION trial was sponsored by the First Affiliated Hospital of University of Science and Technology of China.

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

The benefit of endovascular therapy in the treatment of stroke caused by an occlusion of the basilar artery has finally been confirmed in the ATTENTION randomized trial.

The study, conducted in China, showed that endovascular therapy for basilar artery occlusion is associated with higher rates of favorable and independent outcomes, as well as lower overall disability and lower mortality at 90 days, than best medical management alone.

The results were presented by Raul Nogueira, MD, professor of neurology at the University of Pittsburgh School of Medicine, at the European Stroke Organisation Conference (ESOC) 2022, where they were greeted with applause from the audience.

The number needed to treat was just four.

“There were no surprises with secondary endpoints; everything was highly statistically significant,” Dr. Nogueira said.

Specifically, there was a lower rate of overall disability in the shift analysis, with a common odds ratio of 2.8 favoring the intervention.  

Safety results showed an increased risk for symptomatic ICH in the endovascular group (5.3% vs. 0.0%) but, despite that, 90-day mortality was significantly lower in the endovascular group (36.7% vs. 55.3%).

Dr. Nogueira noted a limitation of the study was that it was conducted in China.

“This was a Chinese study and, as Asians are known to have higher rates of intracranial atherosclerotic disease, the overall degree of generalizability of our findings to Western countries needs to be considered,” he commented.

However, subgroup analysis showed no treatment effect modification based on the presence of intracranial atherosclerotic disease, he noted.

Also, the proportion of comorbidities in the ATTENTION trial was similar to that in the BASICS trial, with the same degree of diabetes and atrial fibrillation.

Dr. Nogueira concluded that, in contrast to previous randomized trials of endovascular treatment for basilar artery occlusion, the ATTENTION trial was able to reinforce consecutive enrollment, resulting in a fast recruitment while minimizing crossovers. 

Furthermore, he pointed out that the overall results are consistent with modern era observational studies, large registries, and meta-analysis.

Commenting on the study, Joanna Wardlaw, MD, professor of applied neuroimaging at the University of Edinburgh (Scotland), and chair of the ESOC Planning Group, said: “This is a very important result, since it provides confirmation beyond doubt the benefit of thrombectomy versus medical therapy for basilar artery occlusion stroke up to 12 hours after onset.”

Dr. Wardlaw added: “The trial was large enough to provide clear results and to enable subgroup analyses; no subgroup did not benefit from thrombectomy.”

In a discussion after the presentation, Urs Fischer, MD, chair of the department of neurology at the University Hospital Basel, Switzerland, said he was not surprised by the results of the ATTENTION trial.

“We have been doing thrombectomy in patients with basilar artery occlusion now for 20 years, although trials are extremely important to answer these questions, so now we have some clear evidence,” Dr. Fischer said. “Nevertheless, there are some caveats, as this is an Asian population, but this is a proof of concept, and it is going in the right direction.”

The ATTENTION trial was sponsored by the First Affiliated Hospital of University of Science and Technology of China.

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

A new study finds clinicians are shifting away from the U.S. Food and Drug Administration–approved combination of warfarin and aspirin after left atrial appendage occlusion (LAAO) with the Watchman device and that adverse events, particularly bleeding, are lower when aspirin is dropped.

Of 31,994 patients successfully implanted with the Watchman 2.5 device in the 3 years after its March 2015 approval, only 1 in 10 received the full postprocedure protocol studied in pivotal trials and codified into the FDA-device approval.

The protocol consisted of aspirin (81-325 mg) indefinitely and warfarin for 45 days. Following transesophageal echocardiography, patients were then maintained on warfarin and aspirin if there was a peridevice leak greater than 5 mm or switched to clopidogrel 75 mg for 6 months if a peridevice leak was ruled out or was 5 mm or less.

Based on the results, drawn from the National Cardiovascular Data Registry (NCDR) LAAO Registry, the most common discharge medications were warfarin and aspirin in 36.9% of patients, followed by a direct oral anticoagulant (DOAC) and aspirin (20.8%), warfarin alone (13.5%), DOAC only (12.3%), and dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor (5%).

“There’s a little bit of practice leading the science in this space,” lead author James V. Freeman, MD, MPH, Yale School of Medicine, New Haven, Conn., told this news organization.

Patients who couldn’t tolerate long-term anticoagulation were excluded from the pivotal trials but are now the patients in whom the device is most often used, because of the Centers for Medicare & Medicaid reimbursement mandate for a relative or absolute contraindication to long-term anticoagulation, he noted.

Not surprisingly, 70% of patients in the registry had history of clinically relevant bleeding, the mean CHA2DS2-VASc score was 4.6, and mean HAS-BLED score was 3. At an average age of 76, they were also older, by years, than those in the clinical trials.

Secular trends at the time also saw the ascendancy of the DOACs relative to warfarin, observed Dr. Freeman. “So I think it’s pretty reasonable for physicians to be considering DOACs rather than warfarin in this context.”
 

Aspirin takes another hit

Results, published May 2 in the Journal of the American College of Cardiology, showed that any adverse event occurred at 45 days in 5.7% of patients discharged on warfarin and aspirin, 4% on warfarin alone, 5.2% on DOAC and aspirin, 3.8% on DOAC only, and 5.5% on DAPT.

Rates of any major adverse event were 4.4%, 3.3%, 4.3%, 3.1%, and 4.2% respectively, and for major bleeding were 3%, 1.8%, 2.8%, 1.7%, and 2.2% respectively. Although patients were similar across treatment groups, those treated with DAPT were slightly older and had more comorbidities, Dr. Freeman said.

In Cox frailty regression, the adjusted risk of any adverse event at 45 days was significantly lower when patients were discharged on warfarin alone (hazard ratio, 0.692; 95% confidence interval, 0.56-0.84) and a DOAC alone (HR, 0.731; 95% CI, 0.57-0.93), compared with warfarin and aspirin. There were no differences among the other groups.

The risk of any major adverse event was also significantly lower with warfarin alone (HR, 0.658; 95% CI, 0.53-0.80) and DOAC alone (HR, 0.767; 95% CI, 0.59-0.98).

At 6 months, rates of any adverse event (HR, 0.814; 95% CI, 0.72-0.93) and any major adverse event (HR, 0.840; 95% CI, 0.73-0.95) were significantly lower only in patients treated with warfarin alone.

“I think if there’s a take-home [message] here, it’s that for a lot of patients there’s good data now to suggest getting rid of the aspirin is a very reasonable thing to do,” Dr. Freeman said.

Further studies are needed in the space, but the results are consistent with those from transcatheter aortic valve replacement studies showing discharge on warfarin or DOAC anticoagulation alone reduces major adverse events without increasing thrombotic events, he said.

“I do think if there’s a strong indication for aspirin – someone has terrible coronary disease – there may be a role for using it,” Dr. Freeman said. But for a lot of these patients, anticoagulation alone without aspirin “may present a big opportunity to mitigate morbidity associated with this procedure.”

Dr. Freeman said he doesn’t expect the findings would be dramatically different with the second-generation Watchman FLX device but noted that randomized data will be forthcoming, as Boston Scientific changed the CHAMPION-AF trial protocol to include DOAC alone without aspirin.

Commenting for this news organization, Domenico Della Rocca, MD, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said the study is a useful overview of post-LAAO therapies in a large population – but not surprising.

“Practice has changed over the years. More and more we are adopting and trusting the DOACs,” he said. “And, we are realizing that dual antiplatelet therapy is so aggressive and antiplatelet therapy alone maybe is not the best choice based on data on activation of coagulation.”

Commenting further, he said “I think it’s too early to suggest being too keen to completely drop aspirin,” noting that 20%-25% of patients have clopidogrel resistance and that the combination of two antiplatelets may be too aggressive a strategy for others.

Dr. Della Rocca and colleagues recently reported favorable long-term results with half-dose DOAC therapy after Watchman implantation and said the team is launching a randomized trial in more than 500 LAAO patients in the United States and Europe later this year. The trial will be comparing a DOAC-based strategy with low-dose apixaban long-term versus clopidogrel and aspirin initially and then switching to 100 mg aspirin long-term.

“We hope that in the next 2-3 years we will have some better answers, but at this point I would say that clopidogrel is kind of an obsolete strategy for appendage closure,” Dr. Della Rocca said.

In an accompanying editorial, David R. Holmes Jr., MD, Mayo Clinic, Rochester, Minn., says “the cornucopia of these specific strategies can be expected to change as practices evolve, as instructions for use broaden and, hopefully, with the results of well-done, scientifically performed trials. This current LAAO Registry report, however, serves as a useful benchmark.”

He cautioned that this is an observational cohort study and that unmeasured imbalances still may affect the ability to identify an unbiased treatment signal. The use of DAPT was also infrequent during the study and “conclusions based on this information are soft.”

The study was funded by the American College of Cardiology National Cardiovascular Data Registry (NCDR), and the National Heart, Lung, and Blood Institute (NHLBI) grants. Dr. Freeman has received salary support from the ACC NCDR and the NHLBI and has received consulting/advisory board fees from Boston Scientific, Medtronic, Janssen Pharmaceuticals, and Biosense Webster.

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

A new study finds clinicians are shifting away from the U.S. Food and Drug Administration–approved combination of warfarin and aspirin after left atrial appendage occlusion (LAAO) with the Watchman device and that adverse events, particularly bleeding, are lower when aspirin is dropped.

Of 31,994 patients successfully implanted with the Watchman 2.5 device in the 3 years after its March 2015 approval, only 1 in 10 received the full postprocedure protocol studied in pivotal trials and codified into the FDA-device approval.

The protocol consisted of aspirin (81-325 mg) indefinitely and warfarin for 45 days. Following transesophageal echocardiography, patients were then maintained on warfarin and aspirin if there was a peridevice leak greater than 5 mm or switched to clopidogrel 75 mg for 6 months if a peridevice leak was ruled out or was 5 mm or less.

Based on the results, drawn from the National Cardiovascular Data Registry (NCDR) LAAO Registry, the most common discharge medications were warfarin and aspirin in 36.9% of patients, followed by a direct oral anticoagulant (DOAC) and aspirin (20.8%), warfarin alone (13.5%), DOAC only (12.3%), and dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor (5%).

“There’s a little bit of practice leading the science in this space,” lead author James V. Freeman, MD, MPH, Yale School of Medicine, New Haven, Conn., told this news organization.

Patients who couldn’t tolerate long-term anticoagulation were excluded from the pivotal trials but are now the patients in whom the device is most often used, because of the Centers for Medicare & Medicaid reimbursement mandate for a relative or absolute contraindication to long-term anticoagulation, he noted.

Not surprisingly, 70% of patients in the registry had history of clinically relevant bleeding, the mean CHA2DS2-VASc score was 4.6, and mean HAS-BLED score was 3. At an average age of 76, they were also older, by years, than those in the clinical trials.

Secular trends at the time also saw the ascendancy of the DOACs relative to warfarin, observed Dr. Freeman. “So I think it’s pretty reasonable for physicians to be considering DOACs rather than warfarin in this context.”
 

Aspirin takes another hit

Results, published May 2 in the Journal of the American College of Cardiology, showed that any adverse event occurred at 45 days in 5.7% of patients discharged on warfarin and aspirin, 4% on warfarin alone, 5.2% on DOAC and aspirin, 3.8% on DOAC only, and 5.5% on DAPT.

Rates of any major adverse event were 4.4%, 3.3%, 4.3%, 3.1%, and 4.2% respectively, and for major bleeding were 3%, 1.8%, 2.8%, 1.7%, and 2.2% respectively. Although patients were similar across treatment groups, those treated with DAPT were slightly older and had more comorbidities, Dr. Freeman said.

In Cox frailty regression, the adjusted risk of any adverse event at 45 days was significantly lower when patients were discharged on warfarin alone (hazard ratio, 0.692; 95% confidence interval, 0.56-0.84) and a DOAC alone (HR, 0.731; 95% CI, 0.57-0.93), compared with warfarin and aspirin. There were no differences among the other groups.

The risk of any major adverse event was also significantly lower with warfarin alone (HR, 0.658; 95% CI, 0.53-0.80) and DOAC alone (HR, 0.767; 95% CI, 0.59-0.98).

At 6 months, rates of any adverse event (HR, 0.814; 95% CI, 0.72-0.93) and any major adverse event (HR, 0.840; 95% CI, 0.73-0.95) were significantly lower only in patients treated with warfarin alone.

“I think if there’s a take-home [message] here, it’s that for a lot of patients there’s good data now to suggest getting rid of the aspirin is a very reasonable thing to do,” Dr. Freeman said.

Further studies are needed in the space, but the results are consistent with those from transcatheter aortic valve replacement studies showing discharge on warfarin or DOAC anticoagulation alone reduces major adverse events without increasing thrombotic events, he said.

“I do think if there’s a strong indication for aspirin – someone has terrible coronary disease – there may be a role for using it,” Dr. Freeman said. But for a lot of these patients, anticoagulation alone without aspirin “may present a big opportunity to mitigate morbidity associated with this procedure.”

Dr. Freeman said he doesn’t expect the findings would be dramatically different with the second-generation Watchman FLX device but noted that randomized data will be forthcoming, as Boston Scientific changed the CHAMPION-AF trial protocol to include DOAC alone without aspirin.

Commenting for this news organization, Domenico Della Rocca, MD, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said the study is a useful overview of post-LAAO therapies in a large population – but not surprising.

“Practice has changed over the years. More and more we are adopting and trusting the DOACs,” he said. “And, we are realizing that dual antiplatelet therapy is so aggressive and antiplatelet therapy alone maybe is not the best choice based on data on activation of coagulation.”

Commenting further, he said “I think it’s too early to suggest being too keen to completely drop aspirin,” noting that 20%-25% of patients have clopidogrel resistance and that the combination of two antiplatelets may be too aggressive a strategy for others.

Dr. Della Rocca and colleagues recently reported favorable long-term results with half-dose DOAC therapy after Watchman implantation and said the team is launching a randomized trial in more than 500 LAAO patients in the United States and Europe later this year. The trial will be comparing a DOAC-based strategy with low-dose apixaban long-term versus clopidogrel and aspirin initially and then switching to 100 mg aspirin long-term.

“We hope that in the next 2-3 years we will have some better answers, but at this point I would say that clopidogrel is kind of an obsolete strategy for appendage closure,” Dr. Della Rocca said.

In an accompanying editorial, David R. Holmes Jr., MD, Mayo Clinic, Rochester, Minn., says “the cornucopia of these specific strategies can be expected to change as practices evolve, as instructions for use broaden and, hopefully, with the results of well-done, scientifically performed trials. This current LAAO Registry report, however, serves as a useful benchmark.”

He cautioned that this is an observational cohort study and that unmeasured imbalances still may affect the ability to identify an unbiased treatment signal. The use of DAPT was also infrequent during the study and “conclusions based on this information are soft.”

The study was funded by the American College of Cardiology National Cardiovascular Data Registry (NCDR), and the National Heart, Lung, and Blood Institute (NHLBI) grants. Dr. Freeman has received salary support from the ACC NCDR and the NHLBI and has received consulting/advisory board fees from Boston Scientific, Medtronic, Janssen Pharmaceuticals, and Biosense Webster.

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

A new study finds clinicians are shifting away from the U.S. Food and Drug Administration–approved combination of warfarin and aspirin after left atrial appendage occlusion (LAAO) with the Watchman device and that adverse events, particularly bleeding, are lower when aspirin is dropped.

Of 31,994 patients successfully implanted with the Watchman 2.5 device in the 3 years after its March 2015 approval, only 1 in 10 received the full postprocedure protocol studied in pivotal trials and codified into the FDA-device approval.

The protocol consisted of aspirin (81-325 mg) indefinitely and warfarin for 45 days. Following transesophageal echocardiography, patients were then maintained on warfarin and aspirin if there was a peridevice leak greater than 5 mm or switched to clopidogrel 75 mg for 6 months if a peridevice leak was ruled out or was 5 mm or less.

Based on the results, drawn from the National Cardiovascular Data Registry (NCDR) LAAO Registry, the most common discharge medications were warfarin and aspirin in 36.9% of patients, followed by a direct oral anticoagulant (DOAC) and aspirin (20.8%), warfarin alone (13.5%), DOAC only (12.3%), and dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor (5%).

“There’s a little bit of practice leading the science in this space,” lead author James V. Freeman, MD, MPH, Yale School of Medicine, New Haven, Conn., told this news organization.

Patients who couldn’t tolerate long-term anticoagulation were excluded from the pivotal trials but are now the patients in whom the device is most often used, because of the Centers for Medicare & Medicaid reimbursement mandate for a relative or absolute contraindication to long-term anticoagulation, he noted.

Not surprisingly, 70% of patients in the registry had history of clinically relevant bleeding, the mean CHA2DS2-VASc score was 4.6, and mean HAS-BLED score was 3. At an average age of 76, they were also older, by years, than those in the clinical trials.

Secular trends at the time also saw the ascendancy of the DOACs relative to warfarin, observed Dr. Freeman. “So I think it’s pretty reasonable for physicians to be considering DOACs rather than warfarin in this context.”
 

Aspirin takes another hit

Results, published May 2 in the Journal of the American College of Cardiology, showed that any adverse event occurred at 45 days in 5.7% of patients discharged on warfarin and aspirin, 4% on warfarin alone, 5.2% on DOAC and aspirin, 3.8% on DOAC only, and 5.5% on DAPT.

Rates of any major adverse event were 4.4%, 3.3%, 4.3%, 3.1%, and 4.2% respectively, and for major bleeding were 3%, 1.8%, 2.8%, 1.7%, and 2.2% respectively. Although patients were similar across treatment groups, those treated with DAPT were slightly older and had more comorbidities, Dr. Freeman said.

In Cox frailty regression, the adjusted risk of any adverse event at 45 days was significantly lower when patients were discharged on warfarin alone (hazard ratio, 0.692; 95% confidence interval, 0.56-0.84) and a DOAC alone (HR, 0.731; 95% CI, 0.57-0.93), compared with warfarin and aspirin. There were no differences among the other groups.

The risk of any major adverse event was also significantly lower with warfarin alone (HR, 0.658; 95% CI, 0.53-0.80) and DOAC alone (HR, 0.767; 95% CI, 0.59-0.98).

At 6 months, rates of any adverse event (HR, 0.814; 95% CI, 0.72-0.93) and any major adverse event (HR, 0.840; 95% CI, 0.73-0.95) were significantly lower only in patients treated with warfarin alone.

“I think if there’s a take-home [message] here, it’s that for a lot of patients there’s good data now to suggest getting rid of the aspirin is a very reasonable thing to do,” Dr. Freeman said.

Further studies are needed in the space, but the results are consistent with those from transcatheter aortic valve replacement studies showing discharge on warfarin or DOAC anticoagulation alone reduces major adverse events without increasing thrombotic events, he said.

“I do think if there’s a strong indication for aspirin – someone has terrible coronary disease – there may be a role for using it,” Dr. Freeman said. But for a lot of these patients, anticoagulation alone without aspirin “may present a big opportunity to mitigate morbidity associated with this procedure.”

Dr. Freeman said he doesn’t expect the findings would be dramatically different with the second-generation Watchman FLX device but noted that randomized data will be forthcoming, as Boston Scientific changed the CHAMPION-AF trial protocol to include DOAC alone without aspirin.

Commenting for this news organization, Domenico Della Rocca, MD, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said the study is a useful overview of post-LAAO therapies in a large population – but not surprising.

“Practice has changed over the years. More and more we are adopting and trusting the DOACs,” he said. “And, we are realizing that dual antiplatelet therapy is so aggressive and antiplatelet therapy alone maybe is not the best choice based on data on activation of coagulation.”

Commenting further, he said “I think it’s too early to suggest being too keen to completely drop aspirin,” noting that 20%-25% of patients have clopidogrel resistance and that the combination of two antiplatelets may be too aggressive a strategy for others.

Dr. Della Rocca and colleagues recently reported favorable long-term results with half-dose DOAC therapy after Watchman implantation and said the team is launching a randomized trial in more than 500 LAAO patients in the United States and Europe later this year. The trial will be comparing a DOAC-based strategy with low-dose apixaban long-term versus clopidogrel and aspirin initially and then switching to 100 mg aspirin long-term.

“We hope that in the next 2-3 years we will have some better answers, but at this point I would say that clopidogrel is kind of an obsolete strategy for appendage closure,” Dr. Della Rocca said.

In an accompanying editorial, David R. Holmes Jr., MD, Mayo Clinic, Rochester, Minn., says “the cornucopia of these specific strategies can be expected to change as practices evolve, as instructions for use broaden and, hopefully, with the results of well-done, scientifically performed trials. This current LAAO Registry report, however, serves as a useful benchmark.”

He cautioned that this is an observational cohort study and that unmeasured imbalances still may affect the ability to identify an unbiased treatment signal. The use of DAPT was also infrequent during the study and “conclusions based on this information are soft.”

The study was funded by the American College of Cardiology National Cardiovascular Data Registry (NCDR), and the National Heart, Lung, and Blood Institute (NHLBI) grants. Dr. Freeman has received salary support from the ACC NCDR and the NHLBI and has received consulting/advisory board fees from Boston Scientific, Medtronic, Janssen Pharmaceuticals, and Biosense Webster.

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