Arrhythmias & EP

Patients who take the vitamin K antagonist warfarin to prevent thromboembolic events are significantly more likely to require knee or hip replacement surgery – a surrogate endpoint for end-stage osteoarthritis – than are patients who take direct oral anticoagulants (DOACs), results of a U.K.-based study showed.

In a nested case-control study, warfarin use was associated with a 1.5-fold risk for knee and hip replacement, compared with use of DOACs.

The findings provide additional evidence for the role of vitamin K and vitamin K–dependent proteins for limiting osteoarthritis progression, said lead author Priyanka Ballal, MD, a rheumatology fellow at Boston University.

“Given the prevalence and impact of osteoarthritis, our data, along with the existing literature, support the need for a well-powered, randomized, controlled trial for evaluating vitamin K supplementation in osteoarthritis. Our study also raises the consideration of using DOACs over warfarin when indicated in people with or at risk of osteoarthritis,“ she said in a plenary session at the virtual annual meeting of the American College of Rheumatology.

Warfarin targets vitamin K for its role in coagulation, but vitamin K is also an essential co-factor for vitamin K-dependent proteins in bone and cartilage, Dr. Ballal said,

Inadequate vitamin K levels are associated with abnormal joint tissue mineralization, and with increased incidence and prevalence of osteoarthritis. In a randomized, controlled trial, vitamin K supplementation was associated with trends toward less osteoarthritis progression among patients with vitamin K deficiency, she said.

To see whether warfarin therapy has biologic effects similar to that seen in patients with vitamin K deficiency, Dr. Ballal and colleagues conducted a nested, case-control study using data from The Health Improvement Network (THIN), an electronic medical record database of patients enrolled with general practitioners in the United Kingdom.

The sample included adults aged 40-80 years with atrial fibrillation who had received one or more prescriptions for warfarin or a DOAC beginning in 2009, a year after DOACs were first marketed in the United Kingdom, and within 1 year of the index date (date of joint replacement surgery). The researchers excluded patients with knee or hip replacements before 2014, severe comorbidities that would limit joint replacement, or who had used either warfarin or a DOAC prior to study entry. Each case was matched by age, gender, and index date with up to four control patients (those who did not have surgery).

A total of 913 cases and 3,652 controls were included. The groups had similar characteristics (sex, age, cancer, renal disease, chronic lung disease, hypertension, and incidence of venous thromboembolism [VTE]), except for somewhat higher rates of diabetes and heart failure among controls, and a higher rate of obesity among cases.

The investigators first looked at warfarin use among all knee and/or hip replacement cases and controls and calculated an odds ratio of 1.57 (95% confidence interval [CI], 1.30-1.89) for knee and hip replacement with warfarin after adjustment for body mass index, factors influencing choice of anticoagulant, comorbidities, other medications, general practitioner visits, and hospitalizations.

The association between warfarin and joint replacement held up in an analysis restricted to knee replacement only, with an adjusted OR of 1.48 (95% CI, 1.16-1.89).

There was also a clear association between duration of warfarin use and risk of knee and hip replacement.

“This abstract suggests the role of adequate vitamin K may be important in decreasing progression of osteoarthritis, which would then favor patients with OA who are on warfarin to consider changing to a DOAC; however, further studies are needed to confirm this finding and consider its impact on VTE and wound healing postop,” said Minna Kohler, MD, director of the rheumatology musculoskeletal ultrasound program at Massachusetts General Hospital in Boston. Dr. Kohler, who was not involved in the study, replied to an email request for comment.

The study was supported by grants from the National Institutes of Health. Dr. Ballal and Dr. Kohler reported having no conflicts of interest to disclose.

SOURCE: Ballal P et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 0934.

Patients who take the vitamin K antagonist warfarin to prevent thromboembolic events are significantly more likely to require knee or hip replacement surgery – a surrogate endpoint for end-stage osteoarthritis – than are patients who take direct oral anticoagulants (DOACs), results of a U.K.-based study showed.

In a nested case-control study, warfarin use was associated with a 1.5-fold risk for knee and hip replacement, compared with use of DOACs.

The findings provide additional evidence for the role of vitamin K and vitamin K–dependent proteins for limiting osteoarthritis progression, said lead author Priyanka Ballal, MD, a rheumatology fellow at Boston University.

“Given the prevalence and impact of osteoarthritis, our data, along with the existing literature, support the need for a well-powered, randomized, controlled trial for evaluating vitamin K supplementation in osteoarthritis. Our study also raises the consideration of using DOACs over warfarin when indicated in people with or at risk of osteoarthritis,“ she said in a plenary session at the virtual annual meeting of the American College of Rheumatology.

Warfarin targets vitamin K for its role in coagulation, but vitamin K is also an essential co-factor for vitamin K-dependent proteins in bone and cartilage, Dr. Ballal said,

Inadequate vitamin K levels are associated with abnormal joint tissue mineralization, and with increased incidence and prevalence of osteoarthritis. In a randomized, controlled trial, vitamin K supplementation was associated with trends toward less osteoarthritis progression among patients with vitamin K deficiency, she said.

To see whether warfarin therapy has biologic effects similar to that seen in patients with vitamin K deficiency, Dr. Ballal and colleagues conducted a nested, case-control study using data from The Health Improvement Network (THIN), an electronic medical record database of patients enrolled with general practitioners in the United Kingdom.

The sample included adults aged 40-80 years with atrial fibrillation who had received one or more prescriptions for warfarin or a DOAC beginning in 2009, a year after DOACs were first marketed in the United Kingdom, and within 1 year of the index date (date of joint replacement surgery). The researchers excluded patients with knee or hip replacements before 2014, severe comorbidities that would limit joint replacement, or who had used either warfarin or a DOAC prior to study entry. Each case was matched by age, gender, and index date with up to four control patients (those who did not have surgery).

A total of 913 cases and 3,652 controls were included. The groups had similar characteristics (sex, age, cancer, renal disease, chronic lung disease, hypertension, and incidence of venous thromboembolism [VTE]), except for somewhat higher rates of diabetes and heart failure among controls, and a higher rate of obesity among cases.

The investigators first looked at warfarin use among all knee and/or hip replacement cases and controls and calculated an odds ratio of 1.57 (95% confidence interval [CI], 1.30-1.89) for knee and hip replacement with warfarin after adjustment for body mass index, factors influencing choice of anticoagulant, comorbidities, other medications, general practitioner visits, and hospitalizations.

The association between warfarin and joint replacement held up in an analysis restricted to knee replacement only, with an adjusted OR of 1.48 (95% CI, 1.16-1.89).

There was also a clear association between duration of warfarin use and risk of knee and hip replacement.

“This abstract suggests the role of adequate vitamin K may be important in decreasing progression of osteoarthritis, which would then favor patients with OA who are on warfarin to consider changing to a DOAC; however, further studies are needed to confirm this finding and consider its impact on VTE and wound healing postop,” said Minna Kohler, MD, director of the rheumatology musculoskeletal ultrasound program at Massachusetts General Hospital in Boston. Dr. Kohler, who was not involved in the study, replied to an email request for comment.

The study was supported by grants from the National Institutes of Health. Dr. Ballal and Dr. Kohler reported having no conflicts of interest to disclose.

SOURCE: Ballal P et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 0934.

Patients who take the vitamin K antagonist warfarin to prevent thromboembolic events are significantly more likely to require knee or hip replacement surgery – a surrogate endpoint for end-stage osteoarthritis – than are patients who take direct oral anticoagulants (DOACs), results of a U.K.-based study showed.

In a nested case-control study, warfarin use was associated with a 1.5-fold risk for knee and hip replacement, compared with use of DOACs.

The findings provide additional evidence for the role of vitamin K and vitamin K–dependent proteins for limiting osteoarthritis progression, said lead author Priyanka Ballal, MD, a rheumatology fellow at Boston University.

“Given the prevalence and impact of osteoarthritis, our data, along with the existing literature, support the need for a well-powered, randomized, controlled trial for evaluating vitamin K supplementation in osteoarthritis. Our study also raises the consideration of using DOACs over warfarin when indicated in people with or at risk of osteoarthritis,“ she said in a plenary session at the virtual annual meeting of the American College of Rheumatology.

Warfarin targets vitamin K for its role in coagulation, but vitamin K is also an essential co-factor for vitamin K-dependent proteins in bone and cartilage, Dr. Ballal said,

Inadequate vitamin K levels are associated with abnormal joint tissue mineralization, and with increased incidence and prevalence of osteoarthritis. In a randomized, controlled trial, vitamin K supplementation was associated with trends toward less osteoarthritis progression among patients with vitamin K deficiency, she said.

To see whether warfarin therapy has biologic effects similar to that seen in patients with vitamin K deficiency, Dr. Ballal and colleagues conducted a nested, case-control study using data from The Health Improvement Network (THIN), an electronic medical record database of patients enrolled with general practitioners in the United Kingdom.

The sample included adults aged 40-80 years with atrial fibrillation who had received one or more prescriptions for warfarin or a DOAC beginning in 2009, a year after DOACs were first marketed in the United Kingdom, and within 1 year of the index date (date of joint replacement surgery). The researchers excluded patients with knee or hip replacements before 2014, severe comorbidities that would limit joint replacement, or who had used either warfarin or a DOAC prior to study entry. Each case was matched by age, gender, and index date with up to four control patients (those who did not have surgery).

A total of 913 cases and 3,652 controls were included. The groups had similar characteristics (sex, age, cancer, renal disease, chronic lung disease, hypertension, and incidence of venous thromboembolism [VTE]), except for somewhat higher rates of diabetes and heart failure among controls, and a higher rate of obesity among cases.

The investigators first looked at warfarin use among all knee and/or hip replacement cases and controls and calculated an odds ratio of 1.57 (95% confidence interval [CI], 1.30-1.89) for knee and hip replacement with warfarin after adjustment for body mass index, factors influencing choice of anticoagulant, comorbidities, other medications, general practitioner visits, and hospitalizations.

The association between warfarin and joint replacement held up in an analysis restricted to knee replacement only, with an adjusted OR of 1.48 (95% CI, 1.16-1.89).

There was also a clear association between duration of warfarin use and risk of knee and hip replacement.

“This abstract suggests the role of adequate vitamin K may be important in decreasing progression of osteoarthritis, which would then favor patients with OA who are on warfarin to consider changing to a DOAC; however, further studies are needed to confirm this finding and consider its impact on VTE and wound healing postop,” said Minna Kohler, MD, director of the rheumatology musculoskeletal ultrasound program at Massachusetts General Hospital in Boston. Dr. Kohler, who was not involved in the study, replied to an email request for comment.

The study was supported by grants from the National Institutes of Health. Dr. Ballal and Dr. Kohler reported having no conflicts of interest to disclose.

SOURCE: Ballal P et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 0934.

A smartphone app that combines passively collected physiologic data from wearable devices, such as fitness trackers, and self-reported symptoms can discriminate between COVID-19–positive and –negative individuals among those who report symptoms, new data suggest.

LDProd/Getty Images

After analyzing data from more than 30,000 participants, researchers from the Digital Engagement and Tracking for Early Control and Treatment (DETECT) study concluded that adding individual changes in sensor data improves models based on symptoms alone for differentiating symptomatic persons who are COVID-19 positive and symptomatic persons who are COVID-19 negative.

The combination can potentially identify infection clusters before wider community spread occurs, Giorgio Quer, PhD, and colleagues report in an article published online Oct. 29 in Nature Medicine. DETECT investigators note that marrying participant-reported symptoms with personal sensor data, such as deviation from normal sleep duration and resting heart rate, resulted in an area under the curve (AUC) of 0.80 (interquartile range [IQR], 0.73-0.86) for differentiating between symptomatic individuals who were positive and those who were negative for COVID-19.

“By better characterizing each individual’s unique baseline, you can then identify changes that may indicate that someone has a viral illness,” said Dr. Quer, director of artificial intelligence at Scripps Research Translational Institute in La Jolla, Calif. “In previous research, we found that the proportion of individuals with elevated resting heart rate and sleep duration compared with their normal could significantly improve real-time detection of influenza-like illness rates at the state level,” he said in an interview.

Thus, continuous passively captured data may be a useful adjunct to bricks-and-mortar site testing, which is generally a one-off or infrequent sampling assay and is not always easily accessible, he added. Furthermore, traditional screening with temperature and symptom reporting is inadequate. An elevation in temperature is not as common as frequently believed for people who test positive for COVID-19, Dr. Quer continued. “Early identification via sensor variables of those who are presymptomatic or even asymptomatic would be especially valuable, as people may potentially be infectious during this period, and early detection is the ultimate goal,” Dr. Quer said.

According to his group, adding these physiologic changes from baseline values significantly outperformed detection (P < .01) using a British model described in an earlier study by by Cristina Menni, PhD, and associates. That method, in which symptoms were considered alone, yielded an AUC of 0.71 (IQR, 0.63-0.79).

According to Dr. Quer, one in five Americans currently wear an electronic device. “If we could enroll even a small percentage of these individuals, we’d be able to potentially identify clusters before they have the opportunity to spread,” he said.
 

DETECT study details

During the period March 15 to June 7, 2020, the study enrolled 30,529 participants from all 50 states. They ranged in age from younger than 35 years (23.1%) to older than 65 years (12.8%); the majority (63.5%) were aged 35-65 years, and 62% were women. Sensor devices in use by the cohort included Fitbit activity trackers (78.4%) and Apple HealthKit (31.2%).

Participants downloaded an app called MyDataHelps, which collects smartwatch and activity tracker information, including self-reported symptoms and diagnostic testing results. The app also monitors changes from baseline in resting heart rate, sleep duration, and physical activity, as measured by steps.

Overall, 3,811 participants reported having at least one symptom of some kind (e.g., fatigue, cough, dyspnea, loss of taste or smell). Of these, 54 reported testing positive for COVID-19, and 279 reported testing negative.

Sleep and activity were significantly different for the positive and negative groups, with an AUC of 0.68 (IQR, 0.57-0.79) for the sleep metric and 0.69 (IQR, 0.61-0.77) for the activity metric, suggesting that these parameters were more affected in COVID-19–positive participants.

When the investigators combined resting heart rate, sleep, and activity into a single metric, predictive performance improved to an AUC of 0.72 (IQR, 0.64-0.80).

The next step, Dr. Quer said, is to include an alert to notify users of possible infection.
 

Alerting users to possible COVID-19 infection

In a similar study, an alert feature was already incorporated. The study, led by Michael P. Snyder, PhD, director of the Center for Genomics and Personalized Medicine at Stanford (Calif.) University, will soon be published online in Nature Biomedical Engineering. In that study, presymptomatic detection of COVID-19 was achieved in more than 80% of participants using resting heart rate.

“The median is 4 days prior to symptom formation,” Dr. Snyder said in an interview. “We have an alarm system to notify people when their heart rate is elevated. So a positive signal from a smartwatch can be used to follow up by polymerase chain reaction [testing].”

Dr. Snyder said these approaches offer a roadmap to containing widespread infections. “Public health authorities need to be open to these technologies and begin incorporating them into their tracking,” he said. “Right now, people do temperature checks, which are of limited value. Resting heart rate is much better information.”

Although the DETECT researchers have not yet received feedback on their results, they believe public health authorities could recommend the use of such apps. “These are devices that people routinely wear for tracking their fitness and sleep, so it would be relatively easy to use the data for viral illness tracking,” said co–lead author Jennifer Radin, PhD, an epidemiologist at Scripps. “Testing resources are still limited and don’t allow for routine serial testing of individuals who may be asymptomatic or presymptomatic. Wearables can offer a different way to routinely monitor and screen people for changes in their data that may indicate COVID-19.”

The marshaling of data through consumer digital platforms to fight the coronavirus is gaining ground. New York State and New Jersey are already embracing smartphone apps to alert individuals to possible exposure to the virus.

More than 710,000 New Yorkers have downloaded the COVID NY Alert app, launched in October to help protect individuals and communities from COVID-19 by sending alerts without compromising privacy or personal information. “Upon receiving a notification about a potential exposure, users are then able to self-quarantine, get tested, and reduce the potential exposure risk to family, friends, coworkers, and others,” Jonah Bruno, a spokesperson for the New York State Department of Health, said in an interview.

And recently the Mayo Clinic and Safe Health Systems launched a platform to store COVID-19 testing and vaccination data.

Both the Scripps and Stanford platforms are part of a global technologic response to the COVID-19 pandemic. Prospective studies, led by device manufacturers and academic institutions, allow individuals to voluntarily share sensor and clinical data to address the crisis. Similar approaches have been used to track COVID-19 in large populations in Germany via the Corona Data Donation app.

The study by Dr. Quer and colleagues was funded by a grant from the National Center for Advancing Translational Sciences at the National Institutes of Health. One coauthor reported grants from Janssen and personal fees from Otsuka and Livongo outside of the submitted work. The other authors have disclosed no relevant financial relationships. Dr. Snyder has ties to Personalis, Qbio, January, SensOmics, Protos, Mirvie, and Oralome.
 

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

A smartphone app that combines passively collected physiologic data from wearable devices, such as fitness trackers, and self-reported symptoms can discriminate between COVID-19–positive and –negative individuals among those who report symptoms, new data suggest.

LDProd/Getty Images

After analyzing data from more than 30,000 participants, researchers from the Digital Engagement and Tracking for Early Control and Treatment (DETECT) study concluded that adding individual changes in sensor data improves models based on symptoms alone for differentiating symptomatic persons who are COVID-19 positive and symptomatic persons who are COVID-19 negative.

The combination can potentially identify infection clusters before wider community spread occurs, Giorgio Quer, PhD, and colleagues report in an article published online Oct. 29 in Nature Medicine. DETECT investigators note that marrying participant-reported symptoms with personal sensor data, such as deviation from normal sleep duration and resting heart rate, resulted in an area under the curve (AUC) of 0.80 (interquartile range [IQR], 0.73-0.86) for differentiating between symptomatic individuals who were positive and those who were negative for COVID-19.

“By better characterizing each individual’s unique baseline, you can then identify changes that may indicate that someone has a viral illness,” said Dr. Quer, director of artificial intelligence at Scripps Research Translational Institute in La Jolla, Calif. “In previous research, we found that the proportion of individuals with elevated resting heart rate and sleep duration compared with their normal could significantly improve real-time detection of influenza-like illness rates at the state level,” he said in an interview.

Thus, continuous passively captured data may be a useful adjunct to bricks-and-mortar site testing, which is generally a one-off or infrequent sampling assay and is not always easily accessible, he added. Furthermore, traditional screening with temperature and symptom reporting is inadequate. An elevation in temperature is not as common as frequently believed for people who test positive for COVID-19, Dr. Quer continued. “Early identification via sensor variables of those who are presymptomatic or even asymptomatic would be especially valuable, as people may potentially be infectious during this period, and early detection is the ultimate goal,” Dr. Quer said.

According to his group, adding these physiologic changes from baseline values significantly outperformed detection (P < .01) using a British model described in an earlier study by by Cristina Menni, PhD, and associates. That method, in which symptoms were considered alone, yielded an AUC of 0.71 (IQR, 0.63-0.79).

According to Dr. Quer, one in five Americans currently wear an electronic device. “If we could enroll even a small percentage of these individuals, we’d be able to potentially identify clusters before they have the opportunity to spread,” he said.
 

DETECT study details

During the period March 15 to June 7, 2020, the study enrolled 30,529 participants from all 50 states. They ranged in age from younger than 35 years (23.1%) to older than 65 years (12.8%); the majority (63.5%) were aged 35-65 years, and 62% were women. Sensor devices in use by the cohort included Fitbit activity trackers (78.4%) and Apple HealthKit (31.2%).

Participants downloaded an app called MyDataHelps, which collects smartwatch and activity tracker information, including self-reported symptoms and diagnostic testing results. The app also monitors changes from baseline in resting heart rate, sleep duration, and physical activity, as measured by steps.

Overall, 3,811 participants reported having at least one symptom of some kind (e.g., fatigue, cough, dyspnea, loss of taste or smell). Of these, 54 reported testing positive for COVID-19, and 279 reported testing negative.

Sleep and activity were significantly different for the positive and negative groups, with an AUC of 0.68 (IQR, 0.57-0.79) for the sleep metric and 0.69 (IQR, 0.61-0.77) for the activity metric, suggesting that these parameters were more affected in COVID-19–positive participants.

When the investigators combined resting heart rate, sleep, and activity into a single metric, predictive performance improved to an AUC of 0.72 (IQR, 0.64-0.80).

The next step, Dr. Quer said, is to include an alert to notify users of possible infection.
 

Alerting users to possible COVID-19 infection

In a similar study, an alert feature was already incorporated. The study, led by Michael P. Snyder, PhD, director of the Center for Genomics and Personalized Medicine at Stanford (Calif.) University, will soon be published online in Nature Biomedical Engineering. In that study, presymptomatic detection of COVID-19 was achieved in more than 80% of participants using resting heart rate.

“The median is 4 days prior to symptom formation,” Dr. Snyder said in an interview. “We have an alarm system to notify people when their heart rate is elevated. So a positive signal from a smartwatch can be used to follow up by polymerase chain reaction [testing].”

Dr. Snyder said these approaches offer a roadmap to containing widespread infections. “Public health authorities need to be open to these technologies and begin incorporating them into their tracking,” he said. “Right now, people do temperature checks, which are of limited value. Resting heart rate is much better information.”

Although the DETECT researchers have not yet received feedback on their results, they believe public health authorities could recommend the use of such apps. “These are devices that people routinely wear for tracking their fitness and sleep, so it would be relatively easy to use the data for viral illness tracking,” said co–lead author Jennifer Radin, PhD, an epidemiologist at Scripps. “Testing resources are still limited and don’t allow for routine serial testing of individuals who may be asymptomatic or presymptomatic. Wearables can offer a different way to routinely monitor and screen people for changes in their data that may indicate COVID-19.”

The marshaling of data through consumer digital platforms to fight the coronavirus is gaining ground. New York State and New Jersey are already embracing smartphone apps to alert individuals to possible exposure to the virus.

More than 710,000 New Yorkers have downloaded the COVID NY Alert app, launched in October to help protect individuals and communities from COVID-19 by sending alerts without compromising privacy or personal information. “Upon receiving a notification about a potential exposure, users are then able to self-quarantine, get tested, and reduce the potential exposure risk to family, friends, coworkers, and others,” Jonah Bruno, a spokesperson for the New York State Department of Health, said in an interview.

And recently the Mayo Clinic and Safe Health Systems launched a platform to store COVID-19 testing and vaccination data.

Both the Scripps and Stanford platforms are part of a global technologic response to the COVID-19 pandemic. Prospective studies, led by device manufacturers and academic institutions, allow individuals to voluntarily share sensor and clinical data to address the crisis. Similar approaches have been used to track COVID-19 in large populations in Germany via the Corona Data Donation app.

The study by Dr. Quer and colleagues was funded by a grant from the National Center for Advancing Translational Sciences at the National Institutes of Health. One coauthor reported grants from Janssen and personal fees from Otsuka and Livongo outside of the submitted work. The other authors have disclosed no relevant financial relationships. Dr. Snyder has ties to Personalis, Qbio, January, SensOmics, Protos, Mirvie, and Oralome.
 

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

A smartphone app that combines passively collected physiologic data from wearable devices, such as fitness trackers, and self-reported symptoms can discriminate between COVID-19–positive and –negative individuals among those who report symptoms, new data suggest.

LDProd/Getty Images

After analyzing data from more than 30,000 participants, researchers from the Digital Engagement and Tracking for Early Control and Treatment (DETECT) study concluded that adding individual changes in sensor data improves models based on symptoms alone for differentiating symptomatic persons who are COVID-19 positive and symptomatic persons who are COVID-19 negative.

The combination can potentially identify infection clusters before wider community spread occurs, Giorgio Quer, PhD, and colleagues report in an article published online Oct. 29 in Nature Medicine. DETECT investigators note that marrying participant-reported symptoms with personal sensor data, such as deviation from normal sleep duration and resting heart rate, resulted in an area under the curve (AUC) of 0.80 (interquartile range [IQR], 0.73-0.86) for differentiating between symptomatic individuals who were positive and those who were negative for COVID-19.

“By better characterizing each individual’s unique baseline, you can then identify changes that may indicate that someone has a viral illness,” said Dr. Quer, director of artificial intelligence at Scripps Research Translational Institute in La Jolla, Calif. “In previous research, we found that the proportion of individuals with elevated resting heart rate and sleep duration compared with their normal could significantly improve real-time detection of influenza-like illness rates at the state level,” he said in an interview.

Thus, continuous passively captured data may be a useful adjunct to bricks-and-mortar site testing, which is generally a one-off or infrequent sampling assay and is not always easily accessible, he added. Furthermore, traditional screening with temperature and symptom reporting is inadequate. An elevation in temperature is not as common as frequently believed for people who test positive for COVID-19, Dr. Quer continued. “Early identification via sensor variables of those who are presymptomatic or even asymptomatic would be especially valuable, as people may potentially be infectious during this period, and early detection is the ultimate goal,” Dr. Quer said.

According to his group, adding these physiologic changes from baseline values significantly outperformed detection (P < .01) using a British model described in an earlier study by by Cristina Menni, PhD, and associates. That method, in which symptoms were considered alone, yielded an AUC of 0.71 (IQR, 0.63-0.79).

According to Dr. Quer, one in five Americans currently wear an electronic device. “If we could enroll even a small percentage of these individuals, we’d be able to potentially identify clusters before they have the opportunity to spread,” he said.
 

DETECT study details

During the period March 15 to June 7, 2020, the study enrolled 30,529 participants from all 50 states. They ranged in age from younger than 35 years (23.1%) to older than 65 years (12.8%); the majority (63.5%) were aged 35-65 years, and 62% were women. Sensor devices in use by the cohort included Fitbit activity trackers (78.4%) and Apple HealthKit (31.2%).

Participants downloaded an app called MyDataHelps, which collects smartwatch and activity tracker information, including self-reported symptoms and diagnostic testing results. The app also monitors changes from baseline in resting heart rate, sleep duration, and physical activity, as measured by steps.

Overall, 3,811 participants reported having at least one symptom of some kind (e.g., fatigue, cough, dyspnea, loss of taste or smell). Of these, 54 reported testing positive for COVID-19, and 279 reported testing negative.

Sleep and activity were significantly different for the positive and negative groups, with an AUC of 0.68 (IQR, 0.57-0.79) for the sleep metric and 0.69 (IQR, 0.61-0.77) for the activity metric, suggesting that these parameters were more affected in COVID-19–positive participants.

When the investigators combined resting heart rate, sleep, and activity into a single metric, predictive performance improved to an AUC of 0.72 (IQR, 0.64-0.80).

The next step, Dr. Quer said, is to include an alert to notify users of possible infection.
 

Alerting users to possible COVID-19 infection

In a similar study, an alert feature was already incorporated. The study, led by Michael P. Snyder, PhD, director of the Center for Genomics and Personalized Medicine at Stanford (Calif.) University, will soon be published online in Nature Biomedical Engineering. In that study, presymptomatic detection of COVID-19 was achieved in more than 80% of participants using resting heart rate.

“The median is 4 days prior to symptom formation,” Dr. Snyder said in an interview. “We have an alarm system to notify people when their heart rate is elevated. So a positive signal from a smartwatch can be used to follow up by polymerase chain reaction [testing].”

Dr. Snyder said these approaches offer a roadmap to containing widespread infections. “Public health authorities need to be open to these technologies and begin incorporating them into their tracking,” he said. “Right now, people do temperature checks, which are of limited value. Resting heart rate is much better information.”

Although the DETECT researchers have not yet received feedback on their results, they believe public health authorities could recommend the use of such apps. “These are devices that people routinely wear for tracking their fitness and sleep, so it would be relatively easy to use the data for viral illness tracking,” said co–lead author Jennifer Radin, PhD, an epidemiologist at Scripps. “Testing resources are still limited and don’t allow for routine serial testing of individuals who may be asymptomatic or presymptomatic. Wearables can offer a different way to routinely monitor and screen people for changes in their data that may indicate COVID-19.”

The marshaling of data through consumer digital platforms to fight the coronavirus is gaining ground. New York State and New Jersey are already embracing smartphone apps to alert individuals to possible exposure to the virus.

More than 710,000 New Yorkers have downloaded the COVID NY Alert app, launched in October to help protect individuals and communities from COVID-19 by sending alerts without compromising privacy or personal information. “Upon receiving a notification about a potential exposure, users are then able to self-quarantine, get tested, and reduce the potential exposure risk to family, friends, coworkers, and others,” Jonah Bruno, a spokesperson for the New York State Department of Health, said in an interview.

And recently the Mayo Clinic and Safe Health Systems launched a platform to store COVID-19 testing and vaccination data.

Both the Scripps and Stanford platforms are part of a global technologic response to the COVID-19 pandemic. Prospective studies, led by device manufacturers and academic institutions, allow individuals to voluntarily share sensor and clinical data to address the crisis. Similar approaches have been used to track COVID-19 in large populations in Germany via the Corona Data Donation app.

The study by Dr. Quer and colleagues was funded by a grant from the National Center for Advancing Translational Sciences at the National Institutes of Health. One coauthor reported grants from Janssen and personal fees from Otsuka and Livongo outside of the submitted work. The other authors have disclosed no relevant financial relationships. Dr. Snyder has ties to Personalis, Qbio, January, SensOmics, Protos, Mirvie, and Oralome.
 

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

The American College of Cardiology (ACC) has released a new Expert Consensus Decision Pathway (ECDP) on the management of conduction disturbances after transcatheter aortic valve replacement (TAVR).

The document provides guidance to clinicians in identifying and managing this common complication of TAVR, covering the pre-TAVR, periprocedural and post-TAVR periods.

“Conduction disturbances after TAVR are common and there is currently heterogeneity in how they’re managed, ranging from a casual observational approach to invasive electrophysiological studies and preemptive pacemaker implantation,” said writing committee chair Scott Lilly, MD, PhD, from the Ohio State Wexner Medical Center in Columbus.

“We felt this kind of collaborative effort to review what little research there is on this topic and come to [an] expert consensus was long overdue,” he added.

The document was published online Oct. 21 in the Journal of the American College of Cardiology.

Dr. Lilly stressed in an interview that this effort is an ECDP and not a guideline “because there is not data out there to solidly stand on and say, ‘This is the way we should do things.’ “

His hope is that this document will generate more discussion on this topic and spur some (probably National Institutes of Health–sponsored) clinical trials to better guide practice.
 

Not uncommon and not decreasing

Complete heart block requiring permanent pacemaker (PPM) implantation is seen in about 15% of patients within 30 days after TAVR. While this is a clear indication for PPM, there is no consensus on the management of less severe conduction disturbances such as new bundle branch or transient complete atrioventricular (AV) heart block.

Unlike the rates of bleeding, vascular injury, and stroke, which have decreased over time, the rates of in-hospital PPM implantation after TAVR have not changed significantly since commercialization in 2012. This is a concern because TAVR is increasingly used in younger, lower-risk patients.

“The pacemaker rate really hasn’t improved at a clip we would like to see if it was going to be a durable technology,” Dr. Lilly said.

Consensus regarding a reasonable strategy to manage cardiac conduction disturbances after TAVR has been elusive. This is a result of several things: a dearth of adequately powered, randomized controlled trials; the often transient nature of the conduction disturbances; evolving technologies; and the interplay of cardiology subspecialties involved.

The 2013 European Society of Cardiology guidelines address pacing post-TAVR, but do not provide in-depth discussion on the topic. This is the first effort sponsored by a cardiovascular society in the United States to review the existing data and experience and propose evidence-based expert guidance.
 

Pre-TAVR assessment

Pre-TAVR assessment should consider the patient’s risk for postprocedure conduction disturbances, the authors said. Since bradyarrythmias and aortic stenosis may present similarly (fatigue, lightheadedness, and syncope being hallmarks of both), a careful history is needed to determine if bradyarrhythmia is present.

An electrocardiogram (ECG) or ambulatory rhythm monitoring may identify baseline conduction abnormalities and help predict the need for post-TAVR PPM.

“In this section, we underscored some of the literature that has raised awareness about the presence of preexisting arrhythmias in TAVR patients and suggest that monitoring in selected patients before the procedure is reasonable, particularly those presenting with syncope or lightheadedness,” said Dr. Lilly.
 

Intraprocedural management

On the day of the procedure, patients determined to have elevated risk for complete AV heart block require careful perioperative ECG and hemodynamic monitoring. Regardless of preexisting risk, said the authors that all patients should be monitored on a telemetry unit during the procedure with ability to do emergency pacing if necessary.

“In the periprocedural section, we address the role of electrophysiological studies for identifying patients at high-risk of subsequent heart block,” said Dr. Lilly. “That’s a practice that’s occurring at a number of centers, but the data out there is insufficient to establish it as a pacemaker indication. Routine EP testing for patients deemed at risk for conduction disturbances after TAVR is not guideline-based and more research is needed.”

The document also outlines the effects of medications and anesthesia on postprocedure conduction abnormalities.
 

Post-TAVR management

The authors define post-TAVR management as continuing through 30-days after discharge.

The ECDP carefully outlines which patients can be discharged without monitoring and those for whom outpatient monitoring can be considered.

“If I’m going to pick one thing from this section, it’s the monitoring piece. A lot of patients that have a conduction disturbance right after TAVR – but you’re not sure if it’s going to progress and require a pacemaker – might stay in the hospital for an extended time waiting to see if the heart holds up,” reported Dr. Lilly.

“But a number of centers are now discharging people at 1 or 2 days, which begs the question: What do you do with these folks? Our group has published data showing that 30-day monitoring in select patients is a safe approach,” said Dr. Lilly.

There are shortcomings, however, in existing data, and recommendations will likely change as more data are collected, he explained.

As well, there remains uncertainty in how conduction block should be managed after TAVR, and clinical judgment is “foundational” in this, wrote the authors.

“This document is meant to help programs deal with these situations right now, acknowledging full and well, that really good randomized clinical data is not available,” said Dr. Lilly.

Dr. Lilly has disclosed no relevant financial relationships. The work of the writing committee was supported exclusively by the American College of Cardiology without commercial support.
 

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

The American College of Cardiology (ACC) has released a new Expert Consensus Decision Pathway (ECDP) on the management of conduction disturbances after transcatheter aortic valve replacement (TAVR).

The document provides guidance to clinicians in identifying and managing this common complication of TAVR, covering the pre-TAVR, periprocedural and post-TAVR periods.

“Conduction disturbances after TAVR are common and there is currently heterogeneity in how they’re managed, ranging from a casual observational approach to invasive electrophysiological studies and preemptive pacemaker implantation,” said writing committee chair Scott Lilly, MD, PhD, from the Ohio State Wexner Medical Center in Columbus.

“We felt this kind of collaborative effort to review what little research there is on this topic and come to [an] expert consensus was long overdue,” he added.

The document was published online Oct. 21 in the Journal of the American College of Cardiology.

Dr. Lilly stressed in an interview that this effort is an ECDP and not a guideline “because there is not data out there to solidly stand on and say, ‘This is the way we should do things.’ “

His hope is that this document will generate more discussion on this topic and spur some (probably National Institutes of Health–sponsored) clinical trials to better guide practice.
 

Not uncommon and not decreasing

Complete heart block requiring permanent pacemaker (PPM) implantation is seen in about 15% of patients within 30 days after TAVR. While this is a clear indication for PPM, there is no consensus on the management of less severe conduction disturbances such as new bundle branch or transient complete atrioventricular (AV) heart block.

Unlike the rates of bleeding, vascular injury, and stroke, which have decreased over time, the rates of in-hospital PPM implantation after TAVR have not changed significantly since commercialization in 2012. This is a concern because TAVR is increasingly used in younger, lower-risk patients.

“The pacemaker rate really hasn’t improved at a clip we would like to see if it was going to be a durable technology,” Dr. Lilly said.

Consensus regarding a reasonable strategy to manage cardiac conduction disturbances after TAVR has been elusive. This is a result of several things: a dearth of adequately powered, randomized controlled trials; the often transient nature of the conduction disturbances; evolving technologies; and the interplay of cardiology subspecialties involved.

The 2013 European Society of Cardiology guidelines address pacing post-TAVR, but do not provide in-depth discussion on the topic. This is the first effort sponsored by a cardiovascular society in the United States to review the existing data and experience and propose evidence-based expert guidance.
 

Pre-TAVR assessment

Pre-TAVR assessment should consider the patient’s risk for postprocedure conduction disturbances, the authors said. Since bradyarrythmias and aortic stenosis may present similarly (fatigue, lightheadedness, and syncope being hallmarks of both), a careful history is needed to determine if bradyarrhythmia is present.

An electrocardiogram (ECG) or ambulatory rhythm monitoring may identify baseline conduction abnormalities and help predict the need for post-TAVR PPM.

“In this section, we underscored some of the literature that has raised awareness about the presence of preexisting arrhythmias in TAVR patients and suggest that monitoring in selected patients before the procedure is reasonable, particularly those presenting with syncope or lightheadedness,” said Dr. Lilly.
 

Intraprocedural management

On the day of the procedure, patients determined to have elevated risk for complete AV heart block require careful perioperative ECG and hemodynamic monitoring. Regardless of preexisting risk, said the authors that all patients should be monitored on a telemetry unit during the procedure with ability to do emergency pacing if necessary.

“In the periprocedural section, we address the role of electrophysiological studies for identifying patients at high-risk of subsequent heart block,” said Dr. Lilly. “That’s a practice that’s occurring at a number of centers, but the data out there is insufficient to establish it as a pacemaker indication. Routine EP testing for patients deemed at risk for conduction disturbances after TAVR is not guideline-based and more research is needed.”

The document also outlines the effects of medications and anesthesia on postprocedure conduction abnormalities.
 

Post-TAVR management

The authors define post-TAVR management as continuing through 30-days after discharge.

The ECDP carefully outlines which patients can be discharged without monitoring and those for whom outpatient monitoring can be considered.

“If I’m going to pick one thing from this section, it’s the monitoring piece. A lot of patients that have a conduction disturbance right after TAVR – but you’re not sure if it’s going to progress and require a pacemaker – might stay in the hospital for an extended time waiting to see if the heart holds up,” reported Dr. Lilly.

“But a number of centers are now discharging people at 1 or 2 days, which begs the question: What do you do with these folks? Our group has published data showing that 30-day monitoring in select patients is a safe approach,” said Dr. Lilly.

There are shortcomings, however, in existing data, and recommendations will likely change as more data are collected, he explained.

As well, there remains uncertainty in how conduction block should be managed after TAVR, and clinical judgment is “foundational” in this, wrote the authors.

“This document is meant to help programs deal with these situations right now, acknowledging full and well, that really good randomized clinical data is not available,” said Dr. Lilly.

Dr. Lilly has disclosed no relevant financial relationships. The work of the writing committee was supported exclusively by the American College of Cardiology without commercial support.
 

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

The American College of Cardiology (ACC) has released a new Expert Consensus Decision Pathway (ECDP) on the management of conduction disturbances after transcatheter aortic valve replacement (TAVR).

The document provides guidance to clinicians in identifying and managing this common complication of TAVR, covering the pre-TAVR, periprocedural and post-TAVR periods.

“Conduction disturbances after TAVR are common and there is currently heterogeneity in how they’re managed, ranging from a casual observational approach to invasive electrophysiological studies and preemptive pacemaker implantation,” said writing committee chair Scott Lilly, MD, PhD, from the Ohio State Wexner Medical Center in Columbus.

“We felt this kind of collaborative effort to review what little research there is on this topic and come to [an] expert consensus was long overdue,” he added.

The document was published online Oct. 21 in the Journal of the American College of Cardiology.

Dr. Lilly stressed in an interview that this effort is an ECDP and not a guideline “because there is not data out there to solidly stand on and say, ‘This is the way we should do things.’ “

His hope is that this document will generate more discussion on this topic and spur some (probably National Institutes of Health–sponsored) clinical trials to better guide practice.
 

Not uncommon and not decreasing

Complete heart block requiring permanent pacemaker (PPM) implantation is seen in about 15% of patients within 30 days after TAVR. While this is a clear indication for PPM, there is no consensus on the management of less severe conduction disturbances such as new bundle branch or transient complete atrioventricular (AV) heart block.

Unlike the rates of bleeding, vascular injury, and stroke, which have decreased over time, the rates of in-hospital PPM implantation after TAVR have not changed significantly since commercialization in 2012. This is a concern because TAVR is increasingly used in younger, lower-risk patients.

“The pacemaker rate really hasn’t improved at a clip we would like to see if it was going to be a durable technology,” Dr. Lilly said.

Consensus regarding a reasonable strategy to manage cardiac conduction disturbances after TAVR has been elusive. This is a result of several things: a dearth of adequately powered, randomized controlled trials; the often transient nature of the conduction disturbances; evolving technologies; and the interplay of cardiology subspecialties involved.

The 2013 European Society of Cardiology guidelines address pacing post-TAVR, but do not provide in-depth discussion on the topic. This is the first effort sponsored by a cardiovascular society in the United States to review the existing data and experience and propose evidence-based expert guidance.
 

Pre-TAVR assessment

Pre-TAVR assessment should consider the patient’s risk for postprocedure conduction disturbances, the authors said. Since bradyarrythmias and aortic stenosis may present similarly (fatigue, lightheadedness, and syncope being hallmarks of both), a careful history is needed to determine if bradyarrhythmia is present.

An electrocardiogram (ECG) or ambulatory rhythm monitoring may identify baseline conduction abnormalities and help predict the need for post-TAVR PPM.

“In this section, we underscored some of the literature that has raised awareness about the presence of preexisting arrhythmias in TAVR patients and suggest that monitoring in selected patients before the procedure is reasonable, particularly those presenting with syncope or lightheadedness,” said Dr. Lilly.
 

Intraprocedural management

On the day of the procedure, patients determined to have elevated risk for complete AV heart block require careful perioperative ECG and hemodynamic monitoring. Regardless of preexisting risk, said the authors that all patients should be monitored on a telemetry unit during the procedure with ability to do emergency pacing if necessary.

“In the periprocedural section, we address the role of electrophysiological studies for identifying patients at high-risk of subsequent heart block,” said Dr. Lilly. “That’s a practice that’s occurring at a number of centers, but the data out there is insufficient to establish it as a pacemaker indication. Routine EP testing for patients deemed at risk for conduction disturbances after TAVR is not guideline-based and more research is needed.”

The document also outlines the effects of medications and anesthesia on postprocedure conduction abnormalities.
 

Post-TAVR management

The authors define post-TAVR management as continuing through 30-days after discharge.

The ECDP carefully outlines which patients can be discharged without monitoring and those for whom outpatient monitoring can be considered.

“If I’m going to pick one thing from this section, it’s the monitoring piece. A lot of patients that have a conduction disturbance right after TAVR – but you’re not sure if it’s going to progress and require a pacemaker – might stay in the hospital for an extended time waiting to see if the heart holds up,” reported Dr. Lilly.

“But a number of centers are now discharging people at 1 or 2 days, which begs the question: What do you do with these folks? Our group has published data showing that 30-day monitoring in select patients is a safe approach,” said Dr. Lilly.

There are shortcomings, however, in existing data, and recommendations will likely change as more data are collected, he explained.

As well, there remains uncertainty in how conduction block should be managed after TAVR, and clinical judgment is “foundational” in this, wrote the authors.

“This document is meant to help programs deal with these situations right now, acknowledging full and well, that really good randomized clinical data is not available,” said Dr. Lilly.

Dr. Lilly has disclosed no relevant financial relationships. The work of the writing committee was supported exclusively by the American College of Cardiology without commercial support.
 

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

Highlights of new updated guidelines for cardiopulmonary resuscitation and emergency cardiovascular care from the American Heart Association include management of opioid-related emergencies; discussion of health disparities; and a new emphasis on physical, social, and emotional recovery after resuscitation.

© American Heart Association, Inc.

The AHA is also exploring digital territory to improve CPR outcomes. The guidelines encourage use of mobile phone technology to summon trained laypeople to individuals requiring CPR, and an adaptive learning suite will be available online for personalized CPR instruction, with lessons catered to individual needs and knowledge levels.

These novel approaches reflect an ongoing effort by the AHA to ensure that the guidelines evolve rapidly with science and technology, reported Raina Merchant, MD, chair of the AHA Emergency Cardiovascular Care Committee and associate professor of emergency medicine at the University of Pennsylvania, Philadelphia, and colleagues. In 2015, the committee shifted from 5-year updates to a continuous online review process, citing a need for more immediate implementation of practice-altering data, they wrote in Circulation.

And new approaches do appear to save lives, at least in a hospital setting.

Since 2004, in-hospital cardiac arrest outcomes have been improving, but similar gains have yet to be realized for out-of-hospital cardiac arrest.

“Much of the variation in survival rates is thought to be due to the strength of the Chain of Survival, the [five] critical actions that must occur in rapid succession to maximize the chance of survival from cardiac arrest,” the committee wrote.
 

Update adds sixth link to Chains of Survival: Recovery

“Recovery expectations and survivorship plans that address treatment, surveillance, and rehabilitation need to be provided to cardiac arrest survivors and their caregivers at hospital discharge to address the sequelae of cardiac arrest and optimize transitions of care to independent physical, social, emotional, and role function,” the committee wrote.

Dr. Merchant and colleagues identified three “critically important” recommendations for both cardiac arrest survivors and caregivers during the recovery process: structured psychological assessment; multimodal rehabilitation assessment and treatment; and comprehensive, multidisciplinary discharge planning.

The recovery process is now part of all four Chains of Survival, which are specific to in-hospital and out-of-hospital arrest for adults and children.
 

New advice on opioid overdoses and bystander training

Among instances of out-of-hospital cardiac arrest, the committee noted that opioid overdoses are “sharply on the rise,” leading to new, scenario-specific recommendations. Among them, the committee encouraged lay rescuers and trained responders to activate emergency response systems immediately while awaiting improvements with naloxone and other interventions. They also suggested that, for individuals in known or suspected cardiac arrest, high-quality CPR, including compressions and ventilation, should be prioritized over naloxone administration.

In a broader discussion, the committee identified disparities in CPR training, which could explain lower rates of bystander CPR and poorer outcomes among certain demographics, such as black and Hispanic populations, as well as those with lower socioeconomic status.

“Targeting training efforts should consider barriers such as language, financial considerations, and poor access to information,” the committee wrote.

While low bystander CPR in these areas may be improved through mobile phone technology that alerts trained laypeople to individuals in need, the committee noted that this approach may be impacted by cultural and geographic factors. To date, use of mobile devices to improve bystander intervention rates has been demonstrated through “uniformly positive data,” but never in North America.

According to the guidelines, bystander intervention rates may also be improved through video-based learning, which is as effective as in-person, instructor-led training.

This led the AHA to create an online adaptive learning platform, which the organization describes as a “digital resuscitation portfolio” that connects programs and courses such as the Resuscitation Quality Improvement program and the HeartCode blended learning course.

“It will cover all of the guideline changes,” said Monica Sales, communications manager at the AHA. “It’s really groundbreaking because it’s the first time that we’re able to kind of close that gap between new science and new products.”

The online content also addresses CPR considerations for COVID-19, which were first addressed by interim CPR guidance published by the AHA in April.

According to Alexis Topjian, MD, coauthor of the present guidelines and pediatric critical care medicine physician at Children’s Hospital of Philadelphia, CPR awareness is more important now than ever.

“The major message [of the guidelines] is that high-quality CPR saves lives,” she said. “So push hard, and push fast. You have the power in your hands to make a difference, more so than ever during this pandemic.”

Concerning coronavirus precautions, Dr. Topjian noted that roughly 70% of out-of-hospital CPR events involve people who know each other, so most bystanders have already been exposed to the person in need, thereby reducing the concern of infection.

When asked about performing CPR on strangers, Dr. Topjian remained encouraging, though she noted that decision making may be informed by local coronavirus rates.

“It’s always a personal choice,” she said.
 

More for clinicians

For clinicians, Dr. Topjian highlighted several recommendations, including use of epinephrine as soon as possible during CPR, preferential use of a cuffed endotracheal tube, continuous EEG monitoring during and after cardiac arrest, and rapid intervention for clinical seizures and of nonconvulsive status epilepticus.

From a pediatric perspective, Dr. Topjian pointed out a change in breathing rate for infants and children who are receiving CPR or rescue breathing with a pulse, from 12-20 breaths/min to 20-30 breaths/min. While not a new recommendation, Dr. Topjian also pointed out the lifesaving benefit of early defibrillation among pediatric patients.

The guidelines were funded by the American Heart Association. The investigators disclosed additional relationships with BTG Pharmaceuticals, Zoll Foundation, the National Institutes of Health, and others.

SOURCE: American Heart Association. Circulation. 2020 Oct 20. Suppl 2.

Highlights of new updated guidelines for cardiopulmonary resuscitation and emergency cardiovascular care from the American Heart Association include management of opioid-related emergencies; discussion of health disparities; and a new emphasis on physical, social, and emotional recovery after resuscitation.

© American Heart Association, Inc.

The AHA is also exploring digital territory to improve CPR outcomes. The guidelines encourage use of mobile phone technology to summon trained laypeople to individuals requiring CPR, and an adaptive learning suite will be available online for personalized CPR instruction, with lessons catered to individual needs and knowledge levels.

These novel approaches reflect an ongoing effort by the AHA to ensure that the guidelines evolve rapidly with science and technology, reported Raina Merchant, MD, chair of the AHA Emergency Cardiovascular Care Committee and associate professor of emergency medicine at the University of Pennsylvania, Philadelphia, and colleagues. In 2015, the committee shifted from 5-year updates to a continuous online review process, citing a need for more immediate implementation of practice-altering data, they wrote in Circulation.

And new approaches do appear to save lives, at least in a hospital setting.

Since 2004, in-hospital cardiac arrest outcomes have been improving, but similar gains have yet to be realized for out-of-hospital cardiac arrest.

“Much of the variation in survival rates is thought to be due to the strength of the Chain of Survival, the [five] critical actions that must occur in rapid succession to maximize the chance of survival from cardiac arrest,” the committee wrote.
 

Update adds sixth link to Chains of Survival: Recovery

“Recovery expectations and survivorship plans that address treatment, surveillance, and rehabilitation need to be provided to cardiac arrest survivors and their caregivers at hospital discharge to address the sequelae of cardiac arrest and optimize transitions of care to independent physical, social, emotional, and role function,” the committee wrote.

Dr. Merchant and colleagues identified three “critically important” recommendations for both cardiac arrest survivors and caregivers during the recovery process: structured psychological assessment; multimodal rehabilitation assessment and treatment; and comprehensive, multidisciplinary discharge planning.

The recovery process is now part of all four Chains of Survival, which are specific to in-hospital and out-of-hospital arrest for adults and children.
 

New advice on opioid overdoses and bystander training

Among instances of out-of-hospital cardiac arrest, the committee noted that opioid overdoses are “sharply on the rise,” leading to new, scenario-specific recommendations. Among them, the committee encouraged lay rescuers and trained responders to activate emergency response systems immediately while awaiting improvements with naloxone and other interventions. They also suggested that, for individuals in known or suspected cardiac arrest, high-quality CPR, including compressions and ventilation, should be prioritized over naloxone administration.

In a broader discussion, the committee identified disparities in CPR training, which could explain lower rates of bystander CPR and poorer outcomes among certain demographics, such as black and Hispanic populations, as well as those with lower socioeconomic status.

“Targeting training efforts should consider barriers such as language, financial considerations, and poor access to information,” the committee wrote.

While low bystander CPR in these areas may be improved through mobile phone technology that alerts trained laypeople to individuals in need, the committee noted that this approach may be impacted by cultural and geographic factors. To date, use of mobile devices to improve bystander intervention rates has been demonstrated through “uniformly positive data,” but never in North America.

According to the guidelines, bystander intervention rates may also be improved through video-based learning, which is as effective as in-person, instructor-led training.

This led the AHA to create an online adaptive learning platform, which the organization describes as a “digital resuscitation portfolio” that connects programs and courses such as the Resuscitation Quality Improvement program and the HeartCode blended learning course.

“It will cover all of the guideline changes,” said Monica Sales, communications manager at the AHA. “It’s really groundbreaking because it’s the first time that we’re able to kind of close that gap between new science and new products.”

The online content also addresses CPR considerations for COVID-19, which were first addressed by interim CPR guidance published by the AHA in April.

According to Alexis Topjian, MD, coauthor of the present guidelines and pediatric critical care medicine physician at Children’s Hospital of Philadelphia, CPR awareness is more important now than ever.

“The major message [of the guidelines] is that high-quality CPR saves lives,” she said. “So push hard, and push fast. You have the power in your hands to make a difference, more so than ever during this pandemic.”

Concerning coronavirus precautions, Dr. Topjian noted that roughly 70% of out-of-hospital CPR events involve people who know each other, so most bystanders have already been exposed to the person in need, thereby reducing the concern of infection.

When asked about performing CPR on strangers, Dr. Topjian remained encouraging, though she noted that decision making may be informed by local coronavirus rates.

“It’s always a personal choice,” she said.
 

More for clinicians

For clinicians, Dr. Topjian highlighted several recommendations, including use of epinephrine as soon as possible during CPR, preferential use of a cuffed endotracheal tube, continuous EEG monitoring during and after cardiac arrest, and rapid intervention for clinical seizures and of nonconvulsive status epilepticus.

From a pediatric perspective, Dr. Topjian pointed out a change in breathing rate for infants and children who are receiving CPR or rescue breathing with a pulse, from 12-20 breaths/min to 20-30 breaths/min. While not a new recommendation, Dr. Topjian also pointed out the lifesaving benefit of early defibrillation among pediatric patients.

The guidelines were funded by the American Heart Association. The investigators disclosed additional relationships with BTG Pharmaceuticals, Zoll Foundation, the National Institutes of Health, and others.

SOURCE: American Heart Association. Circulation. 2020 Oct 20. Suppl 2.

Highlights of new updated guidelines for cardiopulmonary resuscitation and emergency cardiovascular care from the American Heart Association include management of opioid-related emergencies; discussion of health disparities; and a new emphasis on physical, social, and emotional recovery after resuscitation.

© American Heart Association, Inc.

The AHA is also exploring digital territory to improve CPR outcomes. The guidelines encourage use of mobile phone technology to summon trained laypeople to individuals requiring CPR, and an adaptive learning suite will be available online for personalized CPR instruction, with lessons catered to individual needs and knowledge levels.

These novel approaches reflect an ongoing effort by the AHA to ensure that the guidelines evolve rapidly with science and technology, reported Raina Merchant, MD, chair of the AHA Emergency Cardiovascular Care Committee and associate professor of emergency medicine at the University of Pennsylvania, Philadelphia, and colleagues. In 2015, the committee shifted from 5-year updates to a continuous online review process, citing a need for more immediate implementation of practice-altering data, they wrote in Circulation.

And new approaches do appear to save lives, at least in a hospital setting.

Since 2004, in-hospital cardiac arrest outcomes have been improving, but similar gains have yet to be realized for out-of-hospital cardiac arrest.

“Much of the variation in survival rates is thought to be due to the strength of the Chain of Survival, the [five] critical actions that must occur in rapid succession to maximize the chance of survival from cardiac arrest,” the committee wrote.
 

Update adds sixth link to Chains of Survival: Recovery

“Recovery expectations and survivorship plans that address treatment, surveillance, and rehabilitation need to be provided to cardiac arrest survivors and their caregivers at hospital discharge to address the sequelae of cardiac arrest and optimize transitions of care to independent physical, social, emotional, and role function,” the committee wrote.

Dr. Merchant and colleagues identified three “critically important” recommendations for both cardiac arrest survivors and caregivers during the recovery process: structured psychological assessment; multimodal rehabilitation assessment and treatment; and comprehensive, multidisciplinary discharge planning.

The recovery process is now part of all four Chains of Survival, which are specific to in-hospital and out-of-hospital arrest for adults and children.
 

New advice on opioid overdoses and bystander training

Among instances of out-of-hospital cardiac arrest, the committee noted that opioid overdoses are “sharply on the rise,” leading to new, scenario-specific recommendations. Among them, the committee encouraged lay rescuers and trained responders to activate emergency response systems immediately while awaiting improvements with naloxone and other interventions. They also suggested that, for individuals in known or suspected cardiac arrest, high-quality CPR, including compressions and ventilation, should be prioritized over naloxone administration.

In a broader discussion, the committee identified disparities in CPR training, which could explain lower rates of bystander CPR and poorer outcomes among certain demographics, such as black and Hispanic populations, as well as those with lower socioeconomic status.

“Targeting training efforts should consider barriers such as language, financial considerations, and poor access to information,” the committee wrote.

While low bystander CPR in these areas may be improved through mobile phone technology that alerts trained laypeople to individuals in need, the committee noted that this approach may be impacted by cultural and geographic factors. To date, use of mobile devices to improve bystander intervention rates has been demonstrated through “uniformly positive data,” but never in North America.

According to the guidelines, bystander intervention rates may also be improved through video-based learning, which is as effective as in-person, instructor-led training.

This led the AHA to create an online adaptive learning platform, which the organization describes as a “digital resuscitation portfolio” that connects programs and courses such as the Resuscitation Quality Improvement program and the HeartCode blended learning course.

“It will cover all of the guideline changes,” said Monica Sales, communications manager at the AHA. “It’s really groundbreaking because it’s the first time that we’re able to kind of close that gap between new science and new products.”

The online content also addresses CPR considerations for COVID-19, which were first addressed by interim CPR guidance published by the AHA in April.

According to Alexis Topjian, MD, coauthor of the present guidelines and pediatric critical care medicine physician at Children’s Hospital of Philadelphia, CPR awareness is more important now than ever.

“The major message [of the guidelines] is that high-quality CPR saves lives,” she said. “So push hard, and push fast. You have the power in your hands to make a difference, more so than ever during this pandemic.”

Concerning coronavirus precautions, Dr. Topjian noted that roughly 70% of out-of-hospital CPR events involve people who know each other, so most bystanders have already been exposed to the person in need, thereby reducing the concern of infection.

When asked about performing CPR on strangers, Dr. Topjian remained encouraging, though she noted that decision making may be informed by local coronavirus rates.

“It’s always a personal choice,” she said.
 

More for clinicians

For clinicians, Dr. Topjian highlighted several recommendations, including use of epinephrine as soon as possible during CPR, preferential use of a cuffed endotracheal tube, continuous EEG monitoring during and after cardiac arrest, and rapid intervention for clinical seizures and of nonconvulsive status epilepticus.

From a pediatric perspective, Dr. Topjian pointed out a change in breathing rate for infants and children who are receiving CPR or rescue breathing with a pulse, from 12-20 breaths/min to 20-30 breaths/min. While not a new recommendation, Dr. Topjian also pointed out the lifesaving benefit of early defibrillation among pediatric patients.

The guidelines were funded by the American Heart Association. The investigators disclosed additional relationships with BTG Pharmaceuticals, Zoll Foundation, the National Institutes of Health, and others.

SOURCE: American Heart Association. Circulation. 2020 Oct 20. Suppl 2.

Atrial fibrillation has been known to confer an increased risk for poor outcomes after transcatheter aortic valve replacement, but there’s been no evidence of how the etiology of AFib can influence post-TAVR outcomes.

enot-poloskun/Getty Images

Now, a group of researchers from Bern (Switzerland) University are reporting that valvular AFib almost triples the risk of death or debilitating stroke, compared with patients with no AFib, and significantly increases the risk over nonvalvular AFib.*

“The present findings may have implications for risk stratification in patients undergoing TAVR,” wrote Taishi Okuno, MD, and colleagues in what they said is the first study “to appreciate the combined effect” of AFib and mitral stenosis in TAVR. “The identification of valvular AFib may refine the estimated risk for adverse clinical outcomes in patients undergoing TAVR,” they wrote in JACC: Cardiovascular Interventions.

“The fact that valvular AFib seems to confer a higher risk is an interesting finding,” Fred Welt, MD, professor of cardiology at the University of Utah, Salt Lake City, said in an interview. “I think it helps to a certain extent in prognostication because we can say to patients who have concomitant mitral valve disease that they are at higher risk.” Dr. Welt is also chair of the American College of Cardiology Interventional Council.

The analysis included 1,472 patients with aortic stenosis who had TAVR at Bern University Hospital between August 2007 and June 2018, 32% of whom (465) had atrial fibrillation, subcategorized as nonvalvular (26%, 376) and valvular (6%, 89). The primary endpoint, a composite of cardiovascular death or disabling stroke 1 year after TAVR, occurred in 9.3% of patients with no AFib, 14.5% of those with nonvalvular AFib and 24.2% of patients with valvular AFib.

In terms of hazard ratios, patients with nonvalvular AFib had a 57% greater risk of poor outcomes (P = .009) and those with valvular AFib had a 275% greater risk (P < .001), compared with patients with no AFib. Patients with valvular AFib had a 77% higher rate of cardiovascular death or stroke than those with nonvalvular AFib (P = .027).**

In their analysis, Dr. Okuno and colleagues acknowledged that the definition of valvular AFib used in guidelines and clinical trials isn’t uniform. Valvular atrial fibrillation was defined as AFib with mitral stenosis or a mitral valve prosthesis.

To account for the varying definitions of valvular and nonvalvular AFib, the researchers performed a sensitivity analysis of AFib patients with significant valve disease other than mitral stenosis; 42% of patients in the nonvalvular group fit this definition. Patients with AFib and valvular disease other than mitral stenosis had almost twice the risk of cardiovascular death or disabling stroke at 1 year, compared with patients who had AFib but no significant disease of any valve (20.1% vs. 10.9%, P = .03).

Furthermore, when they excluded patients with mild mitral stenosis from the valvular AFib group, “the effect of an increased risk for cardiovascular death or disabling stroke was no longer statistically significant.”

When the researchers separated out the two elements of the composite endpoint, they found valvular AFib carried a significantly higher risk of cardiovascular death – 21.1% (P < .002) vs. 7% for no AFib and 12.3% (P = .003) for nonvalvular AFib. However, the incidence of cardiovascular events – disabling stroke, nondisabling stroke and transient ischemic attack – showed no significant difference across the three groups, Dr. Okuno and colleagues noted. Specifically, the rates of disabling stroke were 3.8%, 3.7% and 5.7% in the no-AFib, nonvalvular-AFib, and valvular-AFib groups, respectively

In an invited editorial, Bernard Iung, MD, and Vincent Algalarrondo, MD, PhD, noted the problems with the definitions for valvular and nonvalvular AFib. “The term valvular AFib now frequently refers to patients with AFib associated with moderate or severe mitral stenosis or a mechanical heart valve,” they wrote. The definition is justified, they noted, because there’s little evidence on the use of non–vitamin K antagonist oral anticoagulants (NOACs) in patients with mitral stenosis.

They noted the term nonvalvular is “ambiguous” because it doesn’t exclude valvular disease but rather only a subset defined by the restrictive use of a class of anticoagulants. Hence, the definition of valvular AFib “is subject to criticisms and remains not standardized.”

“The individualization of valvular AFib in patients undergoing TAVR is debatable, and the definition used in the present study also included mild mitral stenosis and bioprostheses, thereby highlighting again the lack of a clear and uniform definition of the concept of valvular AFib,” they wrote.

While Dr. Welt said the findings may help in stratifying risk in patients with valvular AFib, he’s not certain how that would influence treatment decisions. “In most cases when we’re considering TAVR in these patients it’s because they have severe symptomatic aortic stenosis,” he said.

Surgery as an alternative is fraught with consequences, he said. “Would it be because you would want to repair the mitral valve as well?” he said. “And once you get into that territory, you’re talking about double-valve surgery, which is a much riskier operation than isolated aortic valve replacement.”

The study raises important questions about patients with valvular AFib, Dr. Welt added. “Why are these patients dying at higher rate? Is it some other arrhythmia or some other hemodynamic problem? Are there other things we can learn about these patients that would help us to better treat patients?”

But exploring these findings further with a randomized clinical trial may not be practical, he added. “The number of patients in whom this is an issue is in the scheme of things rather low: 6%,” he said.

Dr. Okuno has no relevant financial disclosures. Dr. Iung is a consultant for Edwards Lifesciences. Dr. Algalarrondo has been a consultant for Pfizer and Alnylam. Dr. Welt disclosed a relationship with Medtronic.

SOURCE: Okuno T et al. JACC Cardiovasc Interv. 2020 Sep 21. doi: 10.1016/j.jcin.2020.05.049.

Corrections, 9/29/20: An earlier version of this article misstated the increase in risk of (*) death or debilitating stroke and of (**) a poor outcome in those with valvular Afib.

Atrial fibrillation has been known to confer an increased risk for poor outcomes after transcatheter aortic valve replacement, but there’s been no evidence of how the etiology of AFib can influence post-TAVR outcomes.

enot-poloskun/Getty Images

Now, a group of researchers from Bern (Switzerland) University are reporting that valvular AFib almost triples the risk of death or debilitating stroke, compared with patients with no AFib, and significantly increases the risk over nonvalvular AFib.*

“The present findings may have implications for risk stratification in patients undergoing TAVR,” wrote Taishi Okuno, MD, and colleagues in what they said is the first study “to appreciate the combined effect” of AFib and mitral stenosis in TAVR. “The identification of valvular AFib may refine the estimated risk for adverse clinical outcomes in patients undergoing TAVR,” they wrote in JACC: Cardiovascular Interventions.

“The fact that valvular AFib seems to confer a higher risk is an interesting finding,” Fred Welt, MD, professor of cardiology at the University of Utah, Salt Lake City, said in an interview. “I think it helps to a certain extent in prognostication because we can say to patients who have concomitant mitral valve disease that they are at higher risk.” Dr. Welt is also chair of the American College of Cardiology Interventional Council.

The analysis included 1,472 patients with aortic stenosis who had TAVR at Bern University Hospital between August 2007 and June 2018, 32% of whom (465) had atrial fibrillation, subcategorized as nonvalvular (26%, 376) and valvular (6%, 89). The primary endpoint, a composite of cardiovascular death or disabling stroke 1 year after TAVR, occurred in 9.3% of patients with no AFib, 14.5% of those with nonvalvular AFib and 24.2% of patients with valvular AFib.

In terms of hazard ratios, patients with nonvalvular AFib had a 57% greater risk of poor outcomes (P = .009) and those with valvular AFib had a 275% greater risk (P < .001), compared with patients with no AFib. Patients with valvular AFib had a 77% higher rate of cardiovascular death or stroke than those with nonvalvular AFib (P = .027).**

In their analysis, Dr. Okuno and colleagues acknowledged that the definition of valvular AFib used in guidelines and clinical trials isn’t uniform. Valvular atrial fibrillation was defined as AFib with mitral stenosis or a mitral valve prosthesis.

To account for the varying definitions of valvular and nonvalvular AFib, the researchers performed a sensitivity analysis of AFib patients with significant valve disease other than mitral stenosis; 42% of patients in the nonvalvular group fit this definition. Patients with AFib and valvular disease other than mitral stenosis had almost twice the risk of cardiovascular death or disabling stroke at 1 year, compared with patients who had AFib but no significant disease of any valve (20.1% vs. 10.9%, P = .03).

Furthermore, when they excluded patients with mild mitral stenosis from the valvular AFib group, “the effect of an increased risk for cardiovascular death or disabling stroke was no longer statistically significant.”

When the researchers separated out the two elements of the composite endpoint, they found valvular AFib carried a significantly higher risk of cardiovascular death – 21.1% (P < .002) vs. 7% for no AFib and 12.3% (P = .003) for nonvalvular AFib. However, the incidence of cardiovascular events – disabling stroke, nondisabling stroke and transient ischemic attack – showed no significant difference across the three groups, Dr. Okuno and colleagues noted. Specifically, the rates of disabling stroke were 3.8%, 3.7% and 5.7% in the no-AFib, nonvalvular-AFib, and valvular-AFib groups, respectively

In an invited editorial, Bernard Iung, MD, and Vincent Algalarrondo, MD, PhD, noted the problems with the definitions for valvular and nonvalvular AFib. “The term valvular AFib now frequently refers to patients with AFib associated with moderate or severe mitral stenosis or a mechanical heart valve,” they wrote. The definition is justified, they noted, because there’s little evidence on the use of non–vitamin K antagonist oral anticoagulants (NOACs) in patients with mitral stenosis.

They noted the term nonvalvular is “ambiguous” because it doesn’t exclude valvular disease but rather only a subset defined by the restrictive use of a class of anticoagulants. Hence, the definition of valvular AFib “is subject to criticisms and remains not standardized.”

“The individualization of valvular AFib in patients undergoing TAVR is debatable, and the definition used in the present study also included mild mitral stenosis and bioprostheses, thereby highlighting again the lack of a clear and uniform definition of the concept of valvular AFib,” they wrote.

While Dr. Welt said the findings may help in stratifying risk in patients with valvular AFib, he’s not certain how that would influence treatment decisions. “In most cases when we’re considering TAVR in these patients it’s because they have severe symptomatic aortic stenosis,” he said.

Surgery as an alternative is fraught with consequences, he said. “Would it be because you would want to repair the mitral valve as well?” he said. “And once you get into that territory, you’re talking about double-valve surgery, which is a much riskier operation than isolated aortic valve replacement.”

The study raises important questions about patients with valvular AFib, Dr. Welt added. “Why are these patients dying at higher rate? Is it some other arrhythmia or some other hemodynamic problem? Are there other things we can learn about these patients that would help us to better treat patients?”

But exploring these findings further with a randomized clinical trial may not be practical, he added. “The number of patients in whom this is an issue is in the scheme of things rather low: 6%,” he said.

Dr. Okuno has no relevant financial disclosures. Dr. Iung is a consultant for Edwards Lifesciences. Dr. Algalarrondo has been a consultant for Pfizer and Alnylam. Dr. Welt disclosed a relationship with Medtronic.

SOURCE: Okuno T et al. JACC Cardiovasc Interv. 2020 Sep 21. doi: 10.1016/j.jcin.2020.05.049.

Corrections, 9/29/20: An earlier version of this article misstated the increase in risk of (*) death or debilitating stroke and of (**) a poor outcome in those with valvular Afib.

Atrial fibrillation has been known to confer an increased risk for poor outcomes after transcatheter aortic valve replacement, but there’s been no evidence of how the etiology of AFib can influence post-TAVR outcomes.

enot-poloskun/Getty Images

Now, a group of researchers from Bern (Switzerland) University are reporting that valvular AFib almost triples the risk of death or debilitating stroke, compared with patients with no AFib, and significantly increases the risk over nonvalvular AFib.*

“The present findings may have implications for risk stratification in patients undergoing TAVR,” wrote Taishi Okuno, MD, and colleagues in what they said is the first study “to appreciate the combined effect” of AFib and mitral stenosis in TAVR. “The identification of valvular AFib may refine the estimated risk for adverse clinical outcomes in patients undergoing TAVR,” they wrote in JACC: Cardiovascular Interventions.

“The fact that valvular AFib seems to confer a higher risk is an interesting finding,” Fred Welt, MD, professor of cardiology at the University of Utah, Salt Lake City, said in an interview. “I think it helps to a certain extent in prognostication because we can say to patients who have concomitant mitral valve disease that they are at higher risk.” Dr. Welt is also chair of the American College of Cardiology Interventional Council.

The analysis included 1,472 patients with aortic stenosis who had TAVR at Bern University Hospital between August 2007 and June 2018, 32% of whom (465) had atrial fibrillation, subcategorized as nonvalvular (26%, 376) and valvular (6%, 89). The primary endpoint, a composite of cardiovascular death or disabling stroke 1 year after TAVR, occurred in 9.3% of patients with no AFib, 14.5% of those with nonvalvular AFib and 24.2% of patients with valvular AFib.

In terms of hazard ratios, patients with nonvalvular AFib had a 57% greater risk of poor outcomes (P = .009) and those with valvular AFib had a 275% greater risk (P < .001), compared with patients with no AFib. Patients with valvular AFib had a 77% higher rate of cardiovascular death or stroke than those with nonvalvular AFib (P = .027).**

In their analysis, Dr. Okuno and colleagues acknowledged that the definition of valvular AFib used in guidelines and clinical trials isn’t uniform. Valvular atrial fibrillation was defined as AFib with mitral stenosis or a mitral valve prosthesis.

To account for the varying definitions of valvular and nonvalvular AFib, the researchers performed a sensitivity analysis of AFib patients with significant valve disease other than mitral stenosis; 42% of patients in the nonvalvular group fit this definition. Patients with AFib and valvular disease other than mitral stenosis had almost twice the risk of cardiovascular death or disabling stroke at 1 year, compared with patients who had AFib but no significant disease of any valve (20.1% vs. 10.9%, P = .03).

Furthermore, when they excluded patients with mild mitral stenosis from the valvular AFib group, “the effect of an increased risk for cardiovascular death or disabling stroke was no longer statistically significant.”

When the researchers separated out the two elements of the composite endpoint, they found valvular AFib carried a significantly higher risk of cardiovascular death – 21.1% (P < .002) vs. 7% for no AFib and 12.3% (P = .003) for nonvalvular AFib. However, the incidence of cardiovascular events – disabling stroke, nondisabling stroke and transient ischemic attack – showed no significant difference across the three groups, Dr. Okuno and colleagues noted. Specifically, the rates of disabling stroke were 3.8%, 3.7% and 5.7% in the no-AFib, nonvalvular-AFib, and valvular-AFib groups, respectively

In an invited editorial, Bernard Iung, MD, and Vincent Algalarrondo, MD, PhD, noted the problems with the definitions for valvular and nonvalvular AFib. “The term valvular AFib now frequently refers to patients with AFib associated with moderate or severe mitral stenosis or a mechanical heart valve,” they wrote. The definition is justified, they noted, because there’s little evidence on the use of non–vitamin K antagonist oral anticoagulants (NOACs) in patients with mitral stenosis.

They noted the term nonvalvular is “ambiguous” because it doesn’t exclude valvular disease but rather only a subset defined by the restrictive use of a class of anticoagulants. Hence, the definition of valvular AFib “is subject to criticisms and remains not standardized.”

“The individualization of valvular AFib in patients undergoing TAVR is debatable, and the definition used in the present study also included mild mitral stenosis and bioprostheses, thereby highlighting again the lack of a clear and uniform definition of the concept of valvular AFib,” they wrote.

While Dr. Welt said the findings may help in stratifying risk in patients with valvular AFib, he’s not certain how that would influence treatment decisions. “In most cases when we’re considering TAVR in these patients it’s because they have severe symptomatic aortic stenosis,” he said.

Surgery as an alternative is fraught with consequences, he said. “Would it be because you would want to repair the mitral valve as well?” he said. “And once you get into that territory, you’re talking about double-valve surgery, which is a much riskier operation than isolated aortic valve replacement.”

The study raises important questions about patients with valvular AFib, Dr. Welt added. “Why are these patients dying at higher rate? Is it some other arrhythmia or some other hemodynamic problem? Are there other things we can learn about these patients that would help us to better treat patients?”

But exploring these findings further with a randomized clinical trial may not be practical, he added. “The number of patients in whom this is an issue is in the scheme of things rather low: 6%,” he said.

Dr. Okuno has no relevant financial disclosures. Dr. Iung is a consultant for Edwards Lifesciences. Dr. Algalarrondo has been a consultant for Pfizer and Alnylam. Dr. Welt disclosed a relationship with Medtronic.

SOURCE: Okuno T et al. JACC Cardiovasc Interv. 2020 Sep 21. doi: 10.1016/j.jcin.2020.05.049.

Corrections, 9/29/20: An earlier version of this article misstated the increase in risk of (*) death or debilitating stroke and of (**) a poor outcome in those with valvular Afib.

The risk for death goes up for patients with atrial fibrillation (AFib) who are put on direct oral anticoagulants (DOAC) at dosages other than those approved for stroke prevention, whether higher or lower than doses specified in the labeling, suggests a large registry study.

A quarter of more than 10,000 patients in the registry took the drugs at such nonrecommended higher or lower dosages. Overwhelmingly it was the latter, perhaps reflecting caution on the part of some practitioners looking to minimize the risk of bleeding complications.

The risk of major bleeding indeed dropped sharply for those taking DOACs at lower-than-recommended levels, but at the cost of a 25% jump in all-cause mortality over 2 years, report investigators from their analysis of patients in the GARFIELD-AF registry published Sept. 14 in the Journal of the American College of Cardiology.

Risks of major bleeding and of stroke or systemic embolism didn’t climb significantly for patients either under- or overdosed.

In general, “physicians are worried about giving too much anticoagulant, and they tend to favor erring on the low-dose side,” lead author A. John Camm, MD, St. George’s University of London, said in an interview. That’s how it was when an oral anticoagulation meant a vitamin K antagonist (VKA) and underdosing was frequent; and it remains an issue in the DOAC era. “It’s not just a little problem. It’s a very big problem.”

Today, clinicians may prescribe DOACs similar to how they prescribed VKAs, by cautiously choosing a lower dosage for selected patients based on their risk profile, Dr. Camm observed. But in contrast to the VKAs, the DOACs “were studied with different dose-reduction strategies, and their labeling requires them to be prescribed according to different parameters.”

They variously base dosage reductions on age, body weight, renal function, or drug-drug interactions, for example, but some clinicians “tend to think that all of those factors should be applied in every instance, with every drug,” he said.

“So I think there’s some confusion and a lot of caution that physicians use with anticoagulants, and they often forget that the purpose of the anticoagulant is to prevent strokes and adverse outcomes such as mortality,” Dr. Camm said. “But by reducing the dose, they expose their patients to these other major cardiovascular events.”

Numerically, the excess mortality among underdosed patients appeared to be driven by death from heart failure or myocardial infarction. There was little or no contribution from sudden death, fatal strokes, or noncardiovascular death.

The findings “remind clinicians to dose DOACs properly and that there are consequences of dosing errors,” observes Gerald V. Naccarelli, MD, of Penn State University and the Milton S. Hershey Medical Center, Hershey, in an accompanying editorial.

Based on the major clinical trials that established the drugs as mainstream stroke-preventive therapy in AFib, as well as extensive regulatory review, each DOAC’s label-recommended dosing “is a guidance of the truth to achieve the highest efficacy and most safety in our patients,” Dr. Naccarelli wrote. “As clinicians are risk adverse, underdosing might result in lower major bleeding rates, and physicians are blamed for bleeding but not necessarily for allowing embolic strokes to occur. These data raise the issue that underdosing is associated with worse patient outcomes.”

The GARFIELD-AF analysis covered 10,426 adults with nonvalvular AFib in 35 countries who initiated a DOAC from 2013 to 2016. The drugs were prescribed at dosages consistent with recommendations in each respective country’s labeling for stroke prevention in AFib in 72.9% of the cohort. Most full and adjusted dose levels approved by the European Medicines Agency, Food and Drug Administration, and regulators in Japan were the same or similar.

But there were a few exceptions. All dosing criteria across the three regulatory domains were the same for apixaban (Eliquis). But variations included lower dosage options for rivaroxaban (Xarelto) and edoxaban (Savaysa, Lixiana) in Japan, and a uniquely low dabigatran (Pradaxa) dosage option in the United States.

The DOAC used least often was the one most frequently underdosed. More than half of patients prescribed edoxaban were given it at a lower-than-recommended dosage.

The adjusted hazard ratio for all-cause mortality at 2 years for DOAC under- or overdosing, compared with dosing at recommended levels, was 1.24 (95% confidence interval, 1.04-1.48). The difference was driven by underdosing, for which the HR was 1.25 (95% CI, 1.04-1.50). The HR for over-dosing was only 1.19 (95% CI, 0.83-1.71).

Multivariate adjustment accounted for age, sex, and ethnicity; type of AFib; diabetes; hypertension; history of bleeding; prior stroke, transient ischemic attack, or systemic embolism; heart failure; vascular disease; smoking; and heavy alcohol consumption.

The risk of stroke or systemic embolism didn’t go up or down significantly for either overdosed or underdosed patients. Neither group showed an increased risk for major bleeding; however, the HR for major bleeding in underdosed patients fell to 0.50 (95% CI, 0.28-0.88).

Underdosing was more common in some world regions than others. The rate exceeded 30% in all Latin American countries except Argentina, the report stated, and in all Asian countries except Singapore.

Japanese patients have long received oral anticoagulation at lower dosages than are used in the West, Dr. Camm observed. When VKAs were the only choice, for example, international normalized ratio targets were consistently a bit lower in Japan than in, for example, North America or Europe.

“And when [novel] OACs were developed, again, the Japanese took the view that their patients are more vulnerable to bleeding, and therefore a lower dose would be appropriate. In some instances, lower-dose regimens have been specifically studied in the Japanese,” Dr. Camm said. “Having said that, this concept of bleeding being more problematic in Asian patients has expanded well beyond Japan, and therefore in many Asian communities, lower doses of [novel] OACs are chosen.”

Many other factors may contribute to DOAC underdosing, including differences in dosing strategies between primary care practitioners and specialists, or between hospital-based and office-based clinicians, for example.

“It might also be argued that a physician who fails to treat a patient adequately in one arena may also be failing to treat the patient well in other aspects of their care,” Dr. Camm proposed. “Therefore you could have increased mortality due to other cardiovascular causes, or even noncardiovascular events, through absence of good quality care. Our study did not address that specifically. But it might be the case, speculatively.”

The study was supported by a grant from Bayer to the Thrombosis Research Institute, “which sponsors the GARFIELD-AF registry.” Dr. Camm discloses receiving grants and personal fees from Bayer, Boehringer Ingelheim, Pfizer/Bristol-Myers Squibb, and Daiichi Sankyo. Disclosures for the other authors are in the report. Dr. Naccarelli disclosed consulting and participating in research for Janssen and serving as a consultant for Milestone, Sanofi, Omeicos, and Acesion Pharma.

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

The risk for death goes up for patients with atrial fibrillation (AFib) who are put on direct oral anticoagulants (DOAC) at dosages other than those approved for stroke prevention, whether higher or lower than doses specified in the labeling, suggests a large registry study.

A quarter of more than 10,000 patients in the registry took the drugs at such nonrecommended higher or lower dosages. Overwhelmingly it was the latter, perhaps reflecting caution on the part of some practitioners looking to minimize the risk of bleeding complications.

The risk of major bleeding indeed dropped sharply for those taking DOACs at lower-than-recommended levels, but at the cost of a 25% jump in all-cause mortality over 2 years, report investigators from their analysis of patients in the GARFIELD-AF registry published Sept. 14 in the Journal of the American College of Cardiology.

Risks of major bleeding and of stroke or systemic embolism didn’t climb significantly for patients either under- or overdosed.

In general, “physicians are worried about giving too much anticoagulant, and they tend to favor erring on the low-dose side,” lead author A. John Camm, MD, St. George’s University of London, said in an interview. That’s how it was when an oral anticoagulation meant a vitamin K antagonist (VKA) and underdosing was frequent; and it remains an issue in the DOAC era. “It’s not just a little problem. It’s a very big problem.”

Today, clinicians may prescribe DOACs similar to how they prescribed VKAs, by cautiously choosing a lower dosage for selected patients based on their risk profile, Dr. Camm observed. But in contrast to the VKAs, the DOACs “were studied with different dose-reduction strategies, and their labeling requires them to be prescribed according to different parameters.”

They variously base dosage reductions on age, body weight, renal function, or drug-drug interactions, for example, but some clinicians “tend to think that all of those factors should be applied in every instance, with every drug,” he said.

“So I think there’s some confusion and a lot of caution that physicians use with anticoagulants, and they often forget that the purpose of the anticoagulant is to prevent strokes and adverse outcomes such as mortality,” Dr. Camm said. “But by reducing the dose, they expose their patients to these other major cardiovascular events.”

Numerically, the excess mortality among underdosed patients appeared to be driven by death from heart failure or myocardial infarction. There was little or no contribution from sudden death, fatal strokes, or noncardiovascular death.

The findings “remind clinicians to dose DOACs properly and that there are consequences of dosing errors,” observes Gerald V. Naccarelli, MD, of Penn State University and the Milton S. Hershey Medical Center, Hershey, in an accompanying editorial.

Based on the major clinical trials that established the drugs as mainstream stroke-preventive therapy in AFib, as well as extensive regulatory review, each DOAC’s label-recommended dosing “is a guidance of the truth to achieve the highest efficacy and most safety in our patients,” Dr. Naccarelli wrote. “As clinicians are risk adverse, underdosing might result in lower major bleeding rates, and physicians are blamed for bleeding but not necessarily for allowing embolic strokes to occur. These data raise the issue that underdosing is associated with worse patient outcomes.”

The GARFIELD-AF analysis covered 10,426 adults with nonvalvular AFib in 35 countries who initiated a DOAC from 2013 to 2016. The drugs were prescribed at dosages consistent with recommendations in each respective country’s labeling for stroke prevention in AFib in 72.9% of the cohort. Most full and adjusted dose levels approved by the European Medicines Agency, Food and Drug Administration, and regulators in Japan were the same or similar.

But there were a few exceptions. All dosing criteria across the three regulatory domains were the same for apixaban (Eliquis). But variations included lower dosage options for rivaroxaban (Xarelto) and edoxaban (Savaysa, Lixiana) in Japan, and a uniquely low dabigatran (Pradaxa) dosage option in the United States.

The DOAC used least often was the one most frequently underdosed. More than half of patients prescribed edoxaban were given it at a lower-than-recommended dosage.

The adjusted hazard ratio for all-cause mortality at 2 years for DOAC under- or overdosing, compared with dosing at recommended levels, was 1.24 (95% confidence interval, 1.04-1.48). The difference was driven by underdosing, for which the HR was 1.25 (95% CI, 1.04-1.50). The HR for over-dosing was only 1.19 (95% CI, 0.83-1.71).

Multivariate adjustment accounted for age, sex, and ethnicity; type of AFib; diabetes; hypertension; history of bleeding; prior stroke, transient ischemic attack, or systemic embolism; heart failure; vascular disease; smoking; and heavy alcohol consumption.

The risk of stroke or systemic embolism didn’t go up or down significantly for either overdosed or underdosed patients. Neither group showed an increased risk for major bleeding; however, the HR for major bleeding in underdosed patients fell to 0.50 (95% CI, 0.28-0.88).

Underdosing was more common in some world regions than others. The rate exceeded 30% in all Latin American countries except Argentina, the report stated, and in all Asian countries except Singapore.

Japanese patients have long received oral anticoagulation at lower dosages than are used in the West, Dr. Camm observed. When VKAs were the only choice, for example, international normalized ratio targets were consistently a bit lower in Japan than in, for example, North America or Europe.

“And when [novel] OACs were developed, again, the Japanese took the view that their patients are more vulnerable to bleeding, and therefore a lower dose would be appropriate. In some instances, lower-dose regimens have been specifically studied in the Japanese,” Dr. Camm said. “Having said that, this concept of bleeding being more problematic in Asian patients has expanded well beyond Japan, and therefore in many Asian communities, lower doses of [novel] OACs are chosen.”

Many other factors may contribute to DOAC underdosing, including differences in dosing strategies between primary care practitioners and specialists, or between hospital-based and office-based clinicians, for example.

“It might also be argued that a physician who fails to treat a patient adequately in one arena may also be failing to treat the patient well in other aspects of their care,” Dr. Camm proposed. “Therefore you could have increased mortality due to other cardiovascular causes, or even noncardiovascular events, through absence of good quality care. Our study did not address that specifically. But it might be the case, speculatively.”

The study was supported by a grant from Bayer to the Thrombosis Research Institute, “which sponsors the GARFIELD-AF registry.” Dr. Camm discloses receiving grants and personal fees from Bayer, Boehringer Ingelheim, Pfizer/Bristol-Myers Squibb, and Daiichi Sankyo. Disclosures for the other authors are in the report. Dr. Naccarelli disclosed consulting and participating in research for Janssen and serving as a consultant for Milestone, Sanofi, Omeicos, and Acesion Pharma.

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

The risk for death goes up for patients with atrial fibrillation (AFib) who are put on direct oral anticoagulants (DOAC) at dosages other than those approved for stroke prevention, whether higher or lower than doses specified in the labeling, suggests a large registry study.

A quarter of more than 10,000 patients in the registry took the drugs at such nonrecommended higher or lower dosages. Overwhelmingly it was the latter, perhaps reflecting caution on the part of some practitioners looking to minimize the risk of bleeding complications.

The risk of major bleeding indeed dropped sharply for those taking DOACs at lower-than-recommended levels, but at the cost of a 25% jump in all-cause mortality over 2 years, report investigators from their analysis of patients in the GARFIELD-AF registry published Sept. 14 in the Journal of the American College of Cardiology.

Risks of major bleeding and of stroke or systemic embolism didn’t climb significantly for patients either under- or overdosed.

In general, “physicians are worried about giving too much anticoagulant, and they tend to favor erring on the low-dose side,” lead author A. John Camm, MD, St. George’s University of London, said in an interview. That’s how it was when an oral anticoagulation meant a vitamin K antagonist (VKA) and underdosing was frequent; and it remains an issue in the DOAC era. “It’s not just a little problem. It’s a very big problem.”

Today, clinicians may prescribe DOACs similar to how they prescribed VKAs, by cautiously choosing a lower dosage for selected patients based on their risk profile, Dr. Camm observed. But in contrast to the VKAs, the DOACs “were studied with different dose-reduction strategies, and their labeling requires them to be prescribed according to different parameters.”

They variously base dosage reductions on age, body weight, renal function, or drug-drug interactions, for example, but some clinicians “tend to think that all of those factors should be applied in every instance, with every drug,” he said.

“So I think there’s some confusion and a lot of caution that physicians use with anticoagulants, and they often forget that the purpose of the anticoagulant is to prevent strokes and adverse outcomes such as mortality,” Dr. Camm said. “But by reducing the dose, they expose their patients to these other major cardiovascular events.”

Numerically, the excess mortality among underdosed patients appeared to be driven by death from heart failure or myocardial infarction. There was little or no contribution from sudden death, fatal strokes, or noncardiovascular death.

The findings “remind clinicians to dose DOACs properly and that there are consequences of dosing errors,” observes Gerald V. Naccarelli, MD, of Penn State University and the Milton S. Hershey Medical Center, Hershey, in an accompanying editorial.

Based on the major clinical trials that established the drugs as mainstream stroke-preventive therapy in AFib, as well as extensive regulatory review, each DOAC’s label-recommended dosing “is a guidance of the truth to achieve the highest efficacy and most safety in our patients,” Dr. Naccarelli wrote. “As clinicians are risk adverse, underdosing might result in lower major bleeding rates, and physicians are blamed for bleeding but not necessarily for allowing embolic strokes to occur. These data raise the issue that underdosing is associated with worse patient outcomes.”

The GARFIELD-AF analysis covered 10,426 adults with nonvalvular AFib in 35 countries who initiated a DOAC from 2013 to 2016. The drugs were prescribed at dosages consistent with recommendations in each respective country’s labeling for stroke prevention in AFib in 72.9% of the cohort. Most full and adjusted dose levels approved by the European Medicines Agency, Food and Drug Administration, and regulators in Japan were the same or similar.

But there were a few exceptions. All dosing criteria across the three regulatory domains were the same for apixaban (Eliquis). But variations included lower dosage options for rivaroxaban (Xarelto) and edoxaban (Savaysa, Lixiana) in Japan, and a uniquely low dabigatran (Pradaxa) dosage option in the United States.

The DOAC used least often was the one most frequently underdosed. More than half of patients prescribed edoxaban were given it at a lower-than-recommended dosage.

The adjusted hazard ratio for all-cause mortality at 2 years for DOAC under- or overdosing, compared with dosing at recommended levels, was 1.24 (95% confidence interval, 1.04-1.48). The difference was driven by underdosing, for which the HR was 1.25 (95% CI, 1.04-1.50). The HR for over-dosing was only 1.19 (95% CI, 0.83-1.71).

Multivariate adjustment accounted for age, sex, and ethnicity; type of AFib; diabetes; hypertension; history of bleeding; prior stroke, transient ischemic attack, or systemic embolism; heart failure; vascular disease; smoking; and heavy alcohol consumption.

The risk of stroke or systemic embolism didn’t go up or down significantly for either overdosed or underdosed patients. Neither group showed an increased risk for major bleeding; however, the HR for major bleeding in underdosed patients fell to 0.50 (95% CI, 0.28-0.88).

Underdosing was more common in some world regions than others. The rate exceeded 30% in all Latin American countries except Argentina, the report stated, and in all Asian countries except Singapore.

Japanese patients have long received oral anticoagulation at lower dosages than are used in the West, Dr. Camm observed. When VKAs were the only choice, for example, international normalized ratio targets were consistently a bit lower in Japan than in, for example, North America or Europe.

“And when [novel] OACs were developed, again, the Japanese took the view that their patients are more vulnerable to bleeding, and therefore a lower dose would be appropriate. In some instances, lower-dose regimens have been specifically studied in the Japanese,” Dr. Camm said. “Having said that, this concept of bleeding being more problematic in Asian patients has expanded well beyond Japan, and therefore in many Asian communities, lower doses of [novel] OACs are chosen.”

Many other factors may contribute to DOAC underdosing, including differences in dosing strategies between primary care practitioners and specialists, or between hospital-based and office-based clinicians, for example.

“It might also be argued that a physician who fails to treat a patient adequately in one arena may also be failing to treat the patient well in other aspects of their care,” Dr. Camm proposed. “Therefore you could have increased mortality due to other cardiovascular causes, or even noncardiovascular events, through absence of good quality care. Our study did not address that specifically. But it might be the case, speculatively.”

The study was supported by a grant from Bayer to the Thrombosis Research Institute, “which sponsors the GARFIELD-AF registry.” Dr. Camm discloses receiving grants and personal fees from Bayer, Boehringer Ingelheim, Pfizer/Bristol-Myers Squibb, and Daiichi Sankyo. Disclosures for the other authors are in the report. Dr. Naccarelli disclosed consulting and participating in research for Janssen and serving as a consultant for Milestone, Sanofi, Omeicos, and Acesion Pharma.

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

New guidelines on sports cardiology from the European Society of Cardiology break fresh ground by green-lighting participation in vigorous competitive sports by selected patients with stable coronary artery disease, heart failure, or mild arrhythmias.

These liberalized guidelines, released at the virtual annual congress of the European Society of Cardiology, thus move well beyond the standard exercise advice to engage in about 150 minutes per week of moderate physical activity, typically defined as brisk walking or its equivalent.

The guidelines reflect a conviction that exercise is powerful medicine for patients with cardiovascular disease and also affords a means to help curb the epidemics of diabetes and obesity that drive cardiovascular risk, according to Antonio Pelliccia, MD, who cochaired the 24-member task force of European and American experts that developed the guidelines.

In a session highlighting the new sports cardiology guidelines, Mats Borjesson, MD, head of the Center for Health and Performance at Gothenburg (Sweden) University, summarized the section devoted to patients with stable coronary artery disease: “If you have established CAD and a low risk of adverse events during exercise, you are eligible for high-intensity exercise and competitive sports. But if you have persistent ischemia despite medical treatment, or symptoms, then you’re only eligible for leisure-time subthreshold activity.”

Dr. Pelliccia put this new recommendation into context.

“We are not talking anymore in this particular disease just about cardiac rehabilitation or leisure-time activity, but we are also opening the border and talking about competitive sports activity in selected patients where you have the evidence for low risk of exercise-induced adverse events. This is a major achievement now for what is the major disease in our adult population,” said Dr. Pelliccia, chief of cardiology at the Institute of Sports Medicine and Science at the Italian National Olympic Committee and professor of sports cardiology at La Sapienza University of Rome.

The recommendation for individualized consideration of all types of exercise, even including vigorous competitive sports, in low-risk patients with CAD gets a class IIa, level of evidence (LOE) C recommendation in the new guidelines. That’s a big step down from a ringing class Ia endorsement, but since sports cardiology is a relatively young field with little evidence that’s based on randomized trials, the guidelines are rife with many other class IIa, LOE C recommendations as well.

“The level of evidence is rather low, so these guidelines are very much the personal perspective of the expert panel,” explained Martin Halle, MD, professor and head of the department of prevention, rehabilitation, and sports cardiology at Technical University of Munich.

The high-risk features for exercise-induced cardiac adverse events in patients with longstanding stable CAD, as cited in the guidelines, include a critical coronary stenosis, defined as a more than 70% lesion in a major coronary artery or a greater than 50% stenosis in the left main, and/or a fractional flow reserve score of less than 0.8; a left ventricular ejection fraction of 50% or less with wall-motion abnormalities; inducible myocardial ischemia on maximal exercise testing; nonsustained ventricular tachycardia; polymorphic or very frequent ventricular premature beats at rest and during maximum stress; and a recent acute coronary syndrome (ACS). These features call for an exercise prescription tailored to remain below the patient’s angina and ischemia thresholds.

“It’s important for cardiologists out there to understand that we definitely need a maximal exercise test. In somebody who is running and has an ACS and then wants to start running again, 200 watts on an ergometer is too low. We have to push them up to the end, and then if everything is okay – left ventricular function is okay, no ischemia, no arrhythmias under exercise testing – then it’s fine,” Dr. Halle said.

Dr. Pelliccia added that close follow-up is needed, because this is an evolving disease.”
 

Exercise and heart failure

Massimo F. Piepoli, MD, PhD, noted that the guidelines give a class IIb, LOE C recommendation for consideration of high-intensity recreational endurance and power sports in patients with heart failure with either midrange or preserved ejection fraction, provided they are stable, asymptomatic, on optimal guideline-directed medical therapy, and without abnormalities on a maximal exercise stress test.

European Society of Cardiology

However, such intense physical activity is not recommended in patients with heart failure with reduced ejection fraction, regardless of their symptom status, added Dr. Piepoli of Guglielmo da Saliceto Hospital in Placenza, Italy.

“We’re talking here, I think for the first time, about possible competitive sports participation in individuals with heart failure, depending on their clinical condition. We are really opening the barriers to sports participation, even in these patients in whom we never thought of it before,” Dr. Pelliccia observed.

Valvular heart disease and exercise

Guidelines panelist Sabiha Gati, MRCP, PhD, said asymptomatic individuals with mild valvular abnormalities can participate in all recreational and competitive sports; that’s a class I, LOE C recommendation.

European Society of Cardiology

“Moderate regurgitant lesions are better tolerated than stenotic lesions, and those with preserved systolic function, good functional capacity, without any exercise-induced arrhythmias or ischemia or abnormal hemodynamic response are considered to be low risk and can participate in all sports,” added Dr. Gati, a cardiologist at Royal Brompton Hospital, London.

The two most common valvular abnormalities encountered in clinical practice are bicuspid aortic valve and mitral valve prolapse. Dr. Gati noted that, while mitral valve prolapse has a benign prognosis in the great majority of affected individuals, the presence of specific features indicative of increased risk for sudden cardiac death precludes participation in strenuous exercise. These include T-wave inversion in the inferior leads on a 12-lead ECG, long QT, bileaflet mitral valve prolapse, basal inferolateral wall fibrosis, severe mitral regurgitation, or a family history of sudden cardiac death.

Bicuspid aortic valve has a prevalence of 1%-2% in the general population. It can be associated with aortic stenosis, aortic regurgitation, and increased risk of ascending aortic aneurysm and dissection. Since it remains unclear whether intensive exercise accelerates aortic dilatation, a cautious approach to sports participation is recommended in patients with an ascending aorta above the normal limit of 40 mm, she said.

The 80-page ESC sports cardiology guidelines, published online simultaneously with their presentation, cover a broad range of additional topics, including exercise recommendations for the general public, for the elderly, as well as for patients with cardiomyopathies, adult congenital heart disease, arrhythmias, and channelopathies. Gaps in evidence are also highlighted.

[email protected]

SOURCE: Pelliccia A. ESC 2020 and Eur Heart J. 2020 Aug 29. doi: 10.1093/eurheartj/ehaa605.

New guidelines on sports cardiology from the European Society of Cardiology break fresh ground by green-lighting participation in vigorous competitive sports by selected patients with stable coronary artery disease, heart failure, or mild arrhythmias.

These liberalized guidelines, released at the virtual annual congress of the European Society of Cardiology, thus move well beyond the standard exercise advice to engage in about 150 minutes per week of moderate physical activity, typically defined as brisk walking or its equivalent.

The guidelines reflect a conviction that exercise is powerful medicine for patients with cardiovascular disease and also affords a means to help curb the epidemics of diabetes and obesity that drive cardiovascular risk, according to Antonio Pelliccia, MD, who cochaired the 24-member task force of European and American experts that developed the guidelines.

In a session highlighting the new sports cardiology guidelines, Mats Borjesson, MD, head of the Center for Health and Performance at Gothenburg (Sweden) University, summarized the section devoted to patients with stable coronary artery disease: “If you have established CAD and a low risk of adverse events during exercise, you are eligible for high-intensity exercise and competitive sports. But if you have persistent ischemia despite medical treatment, or symptoms, then you’re only eligible for leisure-time subthreshold activity.”

Dr. Pelliccia put this new recommendation into context.

“We are not talking anymore in this particular disease just about cardiac rehabilitation or leisure-time activity, but we are also opening the border and talking about competitive sports activity in selected patients where you have the evidence for low risk of exercise-induced adverse events. This is a major achievement now for what is the major disease in our adult population,” said Dr. Pelliccia, chief of cardiology at the Institute of Sports Medicine and Science at the Italian National Olympic Committee and professor of sports cardiology at La Sapienza University of Rome.

The recommendation for individualized consideration of all types of exercise, even including vigorous competitive sports, in low-risk patients with CAD gets a class IIa, level of evidence (LOE) C recommendation in the new guidelines. That’s a big step down from a ringing class Ia endorsement, but since sports cardiology is a relatively young field with little evidence that’s based on randomized trials, the guidelines are rife with many other class IIa, LOE C recommendations as well.

“The level of evidence is rather low, so these guidelines are very much the personal perspective of the expert panel,” explained Martin Halle, MD, professor and head of the department of prevention, rehabilitation, and sports cardiology at Technical University of Munich.

The high-risk features for exercise-induced cardiac adverse events in patients with longstanding stable CAD, as cited in the guidelines, include a critical coronary stenosis, defined as a more than 70% lesion in a major coronary artery or a greater than 50% stenosis in the left main, and/or a fractional flow reserve score of less than 0.8; a left ventricular ejection fraction of 50% or less with wall-motion abnormalities; inducible myocardial ischemia on maximal exercise testing; nonsustained ventricular tachycardia; polymorphic or very frequent ventricular premature beats at rest and during maximum stress; and a recent acute coronary syndrome (ACS). These features call for an exercise prescription tailored to remain below the patient’s angina and ischemia thresholds.

“It’s important for cardiologists out there to understand that we definitely need a maximal exercise test. In somebody who is running and has an ACS and then wants to start running again, 200 watts on an ergometer is too low. We have to push them up to the end, and then if everything is okay – left ventricular function is okay, no ischemia, no arrhythmias under exercise testing – then it’s fine,” Dr. Halle said.

Dr. Pelliccia added that close follow-up is needed, because this is an evolving disease.”
 

Exercise and heart failure

Massimo F. Piepoli, MD, PhD, noted that the guidelines give a class IIb, LOE C recommendation for consideration of high-intensity recreational endurance and power sports in patients with heart failure with either midrange or preserved ejection fraction, provided they are stable, asymptomatic, on optimal guideline-directed medical therapy, and without abnormalities on a maximal exercise stress test.

European Society of Cardiology

However, such intense physical activity is not recommended in patients with heart failure with reduced ejection fraction, regardless of their symptom status, added Dr. Piepoli of Guglielmo da Saliceto Hospital in Placenza, Italy.

“We’re talking here, I think for the first time, about possible competitive sports participation in individuals with heart failure, depending on their clinical condition. We are really opening the barriers to sports participation, even in these patients in whom we never thought of it before,” Dr. Pelliccia observed.

Valvular heart disease and exercise

Guidelines panelist Sabiha Gati, MRCP, PhD, said asymptomatic individuals with mild valvular abnormalities can participate in all recreational and competitive sports; that’s a class I, LOE C recommendation.

European Society of Cardiology

“Moderate regurgitant lesions are better tolerated than stenotic lesions, and those with preserved systolic function, good functional capacity, without any exercise-induced arrhythmias or ischemia or abnormal hemodynamic response are considered to be low risk and can participate in all sports,” added Dr. Gati, a cardiologist at Royal Brompton Hospital, London.

The two most common valvular abnormalities encountered in clinical practice are bicuspid aortic valve and mitral valve prolapse. Dr. Gati noted that, while mitral valve prolapse has a benign prognosis in the great majority of affected individuals, the presence of specific features indicative of increased risk for sudden cardiac death precludes participation in strenuous exercise. These include T-wave inversion in the inferior leads on a 12-lead ECG, long QT, bileaflet mitral valve prolapse, basal inferolateral wall fibrosis, severe mitral regurgitation, or a family history of sudden cardiac death.

Bicuspid aortic valve has a prevalence of 1%-2% in the general population. It can be associated with aortic stenosis, aortic regurgitation, and increased risk of ascending aortic aneurysm and dissection. Since it remains unclear whether intensive exercise accelerates aortic dilatation, a cautious approach to sports participation is recommended in patients with an ascending aorta above the normal limit of 40 mm, she said.

The 80-page ESC sports cardiology guidelines, published online simultaneously with their presentation, cover a broad range of additional topics, including exercise recommendations for the general public, for the elderly, as well as for patients with cardiomyopathies, adult congenital heart disease, arrhythmias, and channelopathies. Gaps in evidence are also highlighted.

[email protected]

SOURCE: Pelliccia A. ESC 2020 and Eur Heart J. 2020 Aug 29. doi: 10.1093/eurheartj/ehaa605.

New guidelines on sports cardiology from the European Society of Cardiology break fresh ground by green-lighting participation in vigorous competitive sports by selected patients with stable coronary artery disease, heart failure, or mild arrhythmias.

These liberalized guidelines, released at the virtual annual congress of the European Society of Cardiology, thus move well beyond the standard exercise advice to engage in about 150 minutes per week of moderate physical activity, typically defined as brisk walking or its equivalent.

The guidelines reflect a conviction that exercise is powerful medicine for patients with cardiovascular disease and also affords a means to help curb the epidemics of diabetes and obesity that drive cardiovascular risk, according to Antonio Pelliccia, MD, who cochaired the 24-member task force of European and American experts that developed the guidelines.

In a session highlighting the new sports cardiology guidelines, Mats Borjesson, MD, head of the Center for Health and Performance at Gothenburg (Sweden) University, summarized the section devoted to patients with stable coronary artery disease: “If you have established CAD and a low risk of adverse events during exercise, you are eligible for high-intensity exercise and competitive sports. But if you have persistent ischemia despite medical treatment, or symptoms, then you’re only eligible for leisure-time subthreshold activity.”

Dr. Pelliccia put this new recommendation into context.

“We are not talking anymore in this particular disease just about cardiac rehabilitation or leisure-time activity, but we are also opening the border and talking about competitive sports activity in selected patients where you have the evidence for low risk of exercise-induced adverse events. This is a major achievement now for what is the major disease in our adult population,” said Dr. Pelliccia, chief of cardiology at the Institute of Sports Medicine and Science at the Italian National Olympic Committee and professor of sports cardiology at La Sapienza University of Rome.

The recommendation for individualized consideration of all types of exercise, even including vigorous competitive sports, in low-risk patients with CAD gets a class IIa, level of evidence (LOE) C recommendation in the new guidelines. That’s a big step down from a ringing class Ia endorsement, but since sports cardiology is a relatively young field with little evidence that’s based on randomized trials, the guidelines are rife with many other class IIa, LOE C recommendations as well.

“The level of evidence is rather low, so these guidelines are very much the personal perspective of the expert panel,” explained Martin Halle, MD, professor and head of the department of prevention, rehabilitation, and sports cardiology at Technical University of Munich.

The high-risk features for exercise-induced cardiac adverse events in patients with longstanding stable CAD, as cited in the guidelines, include a critical coronary stenosis, defined as a more than 70% lesion in a major coronary artery or a greater than 50% stenosis in the left main, and/or a fractional flow reserve score of less than 0.8; a left ventricular ejection fraction of 50% or less with wall-motion abnormalities; inducible myocardial ischemia on maximal exercise testing; nonsustained ventricular tachycardia; polymorphic or very frequent ventricular premature beats at rest and during maximum stress; and a recent acute coronary syndrome (ACS). These features call for an exercise prescription tailored to remain below the patient’s angina and ischemia thresholds.

“It’s important for cardiologists out there to understand that we definitely need a maximal exercise test. In somebody who is running and has an ACS and then wants to start running again, 200 watts on an ergometer is too low. We have to push them up to the end, and then if everything is okay – left ventricular function is okay, no ischemia, no arrhythmias under exercise testing – then it’s fine,” Dr. Halle said.

Dr. Pelliccia added that close follow-up is needed, because this is an evolving disease.”
 

Exercise and heart failure

Massimo F. Piepoli, MD, PhD, noted that the guidelines give a class IIb, LOE C recommendation for consideration of high-intensity recreational endurance and power sports in patients with heart failure with either midrange or preserved ejection fraction, provided they are stable, asymptomatic, on optimal guideline-directed medical therapy, and without abnormalities on a maximal exercise stress test.

European Society of Cardiology

However, such intense physical activity is not recommended in patients with heart failure with reduced ejection fraction, regardless of their symptom status, added Dr. Piepoli of Guglielmo da Saliceto Hospital in Placenza, Italy.

“We’re talking here, I think for the first time, about possible competitive sports participation in individuals with heart failure, depending on their clinical condition. We are really opening the barriers to sports participation, even in these patients in whom we never thought of it before,” Dr. Pelliccia observed.

Valvular heart disease and exercise

Guidelines panelist Sabiha Gati, MRCP, PhD, said asymptomatic individuals with mild valvular abnormalities can participate in all recreational and competitive sports; that’s a class I, LOE C recommendation.

European Society of Cardiology

“Moderate regurgitant lesions are better tolerated than stenotic lesions, and those with preserved systolic function, good functional capacity, without any exercise-induced arrhythmias or ischemia or abnormal hemodynamic response are considered to be low risk and can participate in all sports,” added Dr. Gati, a cardiologist at Royal Brompton Hospital, London.

The two most common valvular abnormalities encountered in clinical practice are bicuspid aortic valve and mitral valve prolapse. Dr. Gati noted that, while mitral valve prolapse has a benign prognosis in the great majority of affected individuals, the presence of specific features indicative of increased risk for sudden cardiac death precludes participation in strenuous exercise. These include T-wave inversion in the inferior leads on a 12-lead ECG, long QT, bileaflet mitral valve prolapse, basal inferolateral wall fibrosis, severe mitral regurgitation, or a family history of sudden cardiac death.

Bicuspid aortic valve has a prevalence of 1%-2% in the general population. It can be associated with aortic stenosis, aortic regurgitation, and increased risk of ascending aortic aneurysm and dissection. Since it remains unclear whether intensive exercise accelerates aortic dilatation, a cautious approach to sports participation is recommended in patients with an ascending aorta above the normal limit of 40 mm, she said.

The 80-page ESC sports cardiology guidelines, published online simultaneously with their presentation, cover a broad range of additional topics, including exercise recommendations for the general public, for the elderly, as well as for patients with cardiomyopathies, adult congenital heart disease, arrhythmias, and channelopathies. Gaps in evidence are also highlighted.

[email protected]

SOURCE: Pelliccia A. ESC 2020 and Eur Heart J. 2020 Aug 29. doi: 10.1093/eurheartj/ehaa605.

A single educational mailing sent by several U.S. health plans to their patients with atrial fibrillation who were candidates for oral anticoagulation, but had not yet started a regimen, failed to boost them over their prescription hurdle and facilitate starting an antithrombotic regimen.

By 1 year following the intervention, a mere 10% of patients in both the intervention and a control arm of the randomized trial had begun treatment, with no signal of incremental uptake because of the mailing, Sean D. Pokorney, MD, said at the virtual annual congress of the European Society of Cardiology. Included in the mailing was an educational letter citing the patient’s atrial fibrillation (AFib) diagnosis, a statement regarding their suitability for oral anticoagulation, some information about the treatment, and a suggestion that recipients discuss this with their personal physician.

Dr. Pokorney acknowledged that the single mailing to patients may not have been adequate to capture patients’ attention and trigger an action, and that repeated messaging via multiple platforms and in coordination with interventions aimed at their health care providers may be what’s needed.

“It will take repeated interventions and engagements. We will need different methods to move the needle,” said Dr. Pokorney, a cardiac electrophysiologist at Duke University in Durham, N.C. The goal is to “empower patients to talk with their health care providers, and to become agents of change” in their care, he explained, but the single, mailed prod wasn’t enough.

An earlier study run by Dr. Pokorney and several of his colleagues used a broader panel of interventions aimed at both patients and clinicians to encourage increased prescribing of oral anticoagulants in five middle income countries, and documented successfully increasing the uptake rate by threefold compared with control patients (Lancet. 2017 Oct 14;390[10104]:1737-46). The current study tested the efficacy of a “much lower-impact intervention,” he admitted.

“The data are “sobering and eye-opening,” said Kalyanam Shivkumar, MD, a cardiac electrophysiologist and professor of medicine at the University of California, Los Angeles. “We’re stuck with this big challenge,” the gap between “what medicine can do and what it actually does” when evidence-based interventions fail to gain traction in everyday practice, he said in an interview.

The numbers collected during the new study highlighted the treatment gap. The IMPACT-AFib study randomized 23,546 patients with AFib and a CHA2DS2-VASc score of at least 2, denoting a stroke risk that warrants oral anticoagulation, to the intervention group, and 23,787 patients to the control arm. The patient selection process began with nearly 200,000 patients who met these criteria, but the researchers excluded 67% because they were already on an oral anticoagulant regimen, an uptake level that roughly matched the 50%-60% level usually seen among U.S. patients, Dr. Pokorney noted. That number coupled with the incremental uptake rate of only 10% of the enrolled patients during the trial, despite their uniform suitability for treatment, underscored how low uptake rates tend to remain stuck over time.

Enrolled patients averaged 78 years of age, with nearly two-thirds at least 75 years old, and with an average CHA2DS2-VASc score of 4.5.

The trial featured a novel design as the first clinical trial to take advantage of the Sentinel program for phase 4 data collection and study devised by the Food and Drug Administration, said Dr. Pokorney. The Sentinel program relies on data partners to provide information; for the IMPACT-AFib study, data came from five large U.S. health systems: Aetna, HealthCore, Humana, Harvard Pilgrim Healthcare, and Optum. Each of these systems sent the mailing to their targeted member patients.

In addition to sending just a single, mailed intervention, the study may have also been limited by the mailing’s content. The educational text, presented by Dr. Pokorney during his talk, focused largely on the potential risks of oral anticoagulation, the limited availability of antidote agents, potential drug and food interactions, and a brief entry about the risk for stroke associated with AFib along with a chart that a patient could use to hand calculate their CHA₂DS₂-VASc score. What the mailing lacked was discussion of the benefits of oral anticoagulation, noted study discussant Christophe LeClercq, MD, a cardiac electrophysiologist and professor of cardiology at the University of Rennes, France.

IMPACT-AFib received no commercial funding, and Dr. Pokorney and Dr. Shivkumar had no disclosures. Dr. Leclercq has received honoraria from Abbott, Biotronik, Boston Scientific, Livanova, and Medtronic.

[email protected]

A single educational mailing sent by several U.S. health plans to their patients with atrial fibrillation who were candidates for oral anticoagulation, but had not yet started a regimen, failed to boost them over their prescription hurdle and facilitate starting an antithrombotic regimen.

By 1 year following the intervention, a mere 10% of patients in both the intervention and a control arm of the randomized trial had begun treatment, with no signal of incremental uptake because of the mailing, Sean D. Pokorney, MD, said at the virtual annual congress of the European Society of Cardiology. Included in the mailing was an educational letter citing the patient’s atrial fibrillation (AFib) diagnosis, a statement regarding their suitability for oral anticoagulation, some information about the treatment, and a suggestion that recipients discuss this with their personal physician.

Dr. Pokorney acknowledged that the single mailing to patients may not have been adequate to capture patients’ attention and trigger an action, and that repeated messaging via multiple platforms and in coordination with interventions aimed at their health care providers may be what’s needed.

“It will take repeated interventions and engagements. We will need different methods to move the needle,” said Dr. Pokorney, a cardiac electrophysiologist at Duke University in Durham, N.C. The goal is to “empower patients to talk with their health care providers, and to become agents of change” in their care, he explained, but the single, mailed prod wasn’t enough.

An earlier study run by Dr. Pokorney and several of his colleagues used a broader panel of interventions aimed at both patients and clinicians to encourage increased prescribing of oral anticoagulants in five middle income countries, and documented successfully increasing the uptake rate by threefold compared with control patients (Lancet. 2017 Oct 14;390[10104]:1737-46). The current study tested the efficacy of a “much lower-impact intervention,” he admitted.

“The data are “sobering and eye-opening,” said Kalyanam Shivkumar, MD, a cardiac electrophysiologist and professor of medicine at the University of California, Los Angeles. “We’re stuck with this big challenge,” the gap between “what medicine can do and what it actually does” when evidence-based interventions fail to gain traction in everyday practice, he said in an interview.

The numbers collected during the new study highlighted the treatment gap. The IMPACT-AFib study randomized 23,546 patients with AFib and a CHA2DS2-VASc score of at least 2, denoting a stroke risk that warrants oral anticoagulation, to the intervention group, and 23,787 patients to the control arm. The patient selection process began with nearly 200,000 patients who met these criteria, but the researchers excluded 67% because they were already on an oral anticoagulant regimen, an uptake level that roughly matched the 50%-60% level usually seen among U.S. patients, Dr. Pokorney noted. That number coupled with the incremental uptake rate of only 10% of the enrolled patients during the trial, despite their uniform suitability for treatment, underscored how low uptake rates tend to remain stuck over time.

Enrolled patients averaged 78 years of age, with nearly two-thirds at least 75 years old, and with an average CHA2DS2-VASc score of 4.5.

The trial featured a novel design as the first clinical trial to take advantage of the Sentinel program for phase 4 data collection and study devised by the Food and Drug Administration, said Dr. Pokorney. The Sentinel program relies on data partners to provide information; for the IMPACT-AFib study, data came from five large U.S. health systems: Aetna, HealthCore, Humana, Harvard Pilgrim Healthcare, and Optum. Each of these systems sent the mailing to their targeted member patients.

In addition to sending just a single, mailed intervention, the study may have also been limited by the mailing’s content. The educational text, presented by Dr. Pokorney during his talk, focused largely on the potential risks of oral anticoagulation, the limited availability of antidote agents, potential drug and food interactions, and a brief entry about the risk for stroke associated with AFib along with a chart that a patient could use to hand calculate their CHA₂DS₂-VASc score. What the mailing lacked was discussion of the benefits of oral anticoagulation, noted study discussant Christophe LeClercq, MD, a cardiac electrophysiologist and professor of cardiology at the University of Rennes, France.

IMPACT-AFib received no commercial funding, and Dr. Pokorney and Dr. Shivkumar had no disclosures. Dr. Leclercq has received honoraria from Abbott, Biotronik, Boston Scientific, Livanova, and Medtronic.

[email protected]

A single educational mailing sent by several U.S. health plans to their patients with atrial fibrillation who were candidates for oral anticoagulation, but had not yet started a regimen, failed to boost them over their prescription hurdle and facilitate starting an antithrombotic regimen.

By 1 year following the intervention, a mere 10% of patients in both the intervention and a control arm of the randomized trial had begun treatment, with no signal of incremental uptake because of the mailing, Sean D. Pokorney, MD, said at the virtual annual congress of the European Society of Cardiology. Included in the mailing was an educational letter citing the patient’s atrial fibrillation (AFib) diagnosis, a statement regarding their suitability for oral anticoagulation, some information about the treatment, and a suggestion that recipients discuss this with their personal physician.

Dr. Pokorney acknowledged that the single mailing to patients may not have been adequate to capture patients’ attention and trigger an action, and that repeated messaging via multiple platforms and in coordination with interventions aimed at their health care providers may be what’s needed.

“It will take repeated interventions and engagements. We will need different methods to move the needle,” said Dr. Pokorney, a cardiac electrophysiologist at Duke University in Durham, N.C. The goal is to “empower patients to talk with their health care providers, and to become agents of change” in their care, he explained, but the single, mailed prod wasn’t enough.

An earlier study run by Dr. Pokorney and several of his colleagues used a broader panel of interventions aimed at both patients and clinicians to encourage increased prescribing of oral anticoagulants in five middle income countries, and documented successfully increasing the uptake rate by threefold compared with control patients (Lancet. 2017 Oct 14;390[10104]:1737-46). The current study tested the efficacy of a “much lower-impact intervention,” he admitted.

“The data are “sobering and eye-opening,” said Kalyanam Shivkumar, MD, a cardiac electrophysiologist and professor of medicine at the University of California, Los Angeles. “We’re stuck with this big challenge,” the gap between “what medicine can do and what it actually does” when evidence-based interventions fail to gain traction in everyday practice, he said in an interview.

The numbers collected during the new study highlighted the treatment gap. The IMPACT-AFib study randomized 23,546 patients with AFib and a CHA2DS2-VASc score of at least 2, denoting a stroke risk that warrants oral anticoagulation, to the intervention group, and 23,787 patients to the control arm. The patient selection process began with nearly 200,000 patients who met these criteria, but the researchers excluded 67% because they were already on an oral anticoagulant regimen, an uptake level that roughly matched the 50%-60% level usually seen among U.S. patients, Dr. Pokorney noted. That number coupled with the incremental uptake rate of only 10% of the enrolled patients during the trial, despite their uniform suitability for treatment, underscored how low uptake rates tend to remain stuck over time.

Enrolled patients averaged 78 years of age, with nearly two-thirds at least 75 years old, and with an average CHA2DS2-VASc score of 4.5.

The trial featured a novel design as the first clinical trial to take advantage of the Sentinel program for phase 4 data collection and study devised by the Food and Drug Administration, said Dr. Pokorney. The Sentinel program relies on data partners to provide information; for the IMPACT-AFib study, data came from five large U.S. health systems: Aetna, HealthCore, Humana, Harvard Pilgrim Healthcare, and Optum. Each of these systems sent the mailing to their targeted member patients.

In addition to sending just a single, mailed intervention, the study may have also been limited by the mailing’s content. The educational text, presented by Dr. Pokorney during his talk, focused largely on the potential risks of oral anticoagulation, the limited availability of antidote agents, potential drug and food interactions, and a brief entry about the risk for stroke associated with AFib along with a chart that a patient could use to hand calculate their CHA₂DS₂-VASc score. What the mailing lacked was discussion of the benefits of oral anticoagulation, noted study discussant Christophe LeClercq, MD, a cardiac electrophysiologist and professor of cardiology at the University of Rennes, France.

IMPACT-AFib received no commercial funding, and Dr. Pokorney and Dr. Shivkumar had no disclosures. Dr. Leclercq has received honoraria from Abbott, Biotronik, Boston Scientific, Livanova, and Medtronic.

[email protected]

The pragmatic Hestia criteria proved as safe as the more structured, points-based simplified Pulmonary Embolism Severity Index (sPESI) score for selection of patients with acute pulmonary embolism for outpatient care in the large, randomized HOME-PE trial presented at the virtual annual congress of the European Society of Cardiology.

Courtesy Wikimedia Commons/Walter Serra, Giuseppe De Iaco, Claudio Reverberi, and Tiziano Gherli/Creative Commons License

“These results support outpatient management of acute pulmonary embolism patients using either the Hestia method or the sPESI score with the option for the physician-in-charge to override the decision. In hospitals organized for outpatient management, both triaging strategies enable more than a third of pulmonary embolism patients to be managed at home with a low rate of complications,” Pierre-Marie Roy, MD, said in presenting the HOME-PE findings.

The study clarifies a transatlantic controversy regarding how best to triage patients with acute pulmonary embolism (PE) for outpatient care. The answer? It’s basically a tie between the points-based sPESI score recommended in the current ESC guidelines (Eur Respir J. 2019 Oct 9;54[3]:1901647) and the Hestia method endorsed in the American College of Chest Physician guidelines (Chest. 2016 Feb;149[2]:315-52).

The sPESI is a validated tool that grants 1 point each for age over 80 years, background cardiopulmonary disease, a systolic blood pressure below 100 mm Hg, cancer, a heart rate of 110 bpm or more, and an oxygen saturation level below 90%. A patient needs a score of zero to be eligible for outpatient management. In contrast, the Hestia method relies upon 11 simple bedside criteria rather than a points system, explained Dr. Roy of University Hospital of Angers, France (J Thromb Haemost. 2011 Aug;9[8]:1500-7).

HOME-PE was a randomized, open-label, noninferiority trial conducted at 26 hospitals in France, Belgium, Switzerland, and the Netherlands. The study included 1,974 patients presenting to the emergency department with non–high-risk acute PE as defined by hemodynamic stability. About 39% of patients in the Hestia group were eligible for outpatient care on the basis of ‘no’ answers regarding all 11 criteria, while 48% of patients had an sPESI score of 0 and were thus initially considered appropriate for outpatient management.

However, the investigators recognized that no scoring system for acute PE is perfect, and that the judgment of a physician with extensive experience in managing this life-threatening condition counts for a lot. So they stipulated that a patient’s physician-in-charge could overrule a decision for early discharge. This happened 29% of the time in patients with a sPESI score of 0, as compared with a 3% overrule rate with the Hestia rule. The physician-in-charge also moved small numbers of patients who were Hestia or sPESI positive into the outpatient care group. As a result, a similar proportion of patients in both groups were discharged home within 24 hours for outpatient treatment: 38% of the total Hestia group and 37% in the sPESI arm.

Major adverse event rates were reassuringly low in both groups managed on an outpatient basis. The composite of recurrent venous thromboembolism, bleeding, or death within 30 days occurred in 1.3% of Hestia outpatients and 1.1% of sPESI outpatients. Among patients managed in the hospital, these rates were 5.6% in the Hestia group and 4.7% in the sPESI group.

Discussant Stavros V. Konstantinides, MD, who chaired the ESC guideline committee, asked rhetorically, “who’s happy with the HOME-PE trial? I think everybody.”

“The Hestia criteria integrate the feasibility of family support of the individual patient. This is a good thing. And eligibility based on the Hestia criteria, unlike sPESI, does not require age younger than 80 years or no cancer, and it appears from the HOME-PE study that this is okay,” observed Dr. Konstantinides of the Center for Thrombosis and Hemostasis at the University of Mainz (Germany).

In an interview, Hadley Wilson, MD, called the HOME-PE trial “transformative” and predicted it will change clinical practice. He was particularly impressed with the high quality of the trial, noting that 87% of participants managed as outpatients received a direct oral anticoagulant.

The Hestia rule is simpler and more user-friendly. And greater use of this triaging strategy might have advantages in terms of economics and health care utilization by potentially encouraging movement of decision-making regarding outpatient management of acute PE out of the hospital wards and into emergency departments, said Dr. Wilson, executive vice chair of the Sanger Heart and Vascular Institute and a cardiologist at the University of North Carolina at Chapel Hill.

Dr. Roy reported receiving research grants to conduct HOME-PE from the French Ministry of Health, the study sponsor. In addition, he is on scientific advisory boards and/or speakers’ panels for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Aspen, Daiichi Sankyo, and Sanofi Aventis.
 

[email protected]

The pragmatic Hestia criteria proved as safe as the more structured, points-based simplified Pulmonary Embolism Severity Index (sPESI) score for selection of patients with acute pulmonary embolism for outpatient care in the large, randomized HOME-PE trial presented at the virtual annual congress of the European Society of Cardiology.

Courtesy Wikimedia Commons/Walter Serra, Giuseppe De Iaco, Claudio Reverberi, and Tiziano Gherli/Creative Commons License

“These results support outpatient management of acute pulmonary embolism patients using either the Hestia method or the sPESI score with the option for the physician-in-charge to override the decision. In hospitals organized for outpatient management, both triaging strategies enable more than a third of pulmonary embolism patients to be managed at home with a low rate of complications,” Pierre-Marie Roy, MD, said in presenting the HOME-PE findings.

The study clarifies a transatlantic controversy regarding how best to triage patients with acute pulmonary embolism (PE) for outpatient care. The answer? It’s basically a tie between the points-based sPESI score recommended in the current ESC guidelines (Eur Respir J. 2019 Oct 9;54[3]:1901647) and the Hestia method endorsed in the American College of Chest Physician guidelines (Chest. 2016 Feb;149[2]:315-52).

The sPESI is a validated tool that grants 1 point each for age over 80 years, background cardiopulmonary disease, a systolic blood pressure below 100 mm Hg, cancer, a heart rate of 110 bpm or more, and an oxygen saturation level below 90%. A patient needs a score of zero to be eligible for outpatient management. In contrast, the Hestia method relies upon 11 simple bedside criteria rather than a points system, explained Dr. Roy of University Hospital of Angers, France (J Thromb Haemost. 2011 Aug;9[8]:1500-7).

HOME-PE was a randomized, open-label, noninferiority trial conducted at 26 hospitals in France, Belgium, Switzerland, and the Netherlands. The study included 1,974 patients presenting to the emergency department with non–high-risk acute PE as defined by hemodynamic stability. About 39% of patients in the Hestia group were eligible for outpatient care on the basis of ‘no’ answers regarding all 11 criteria, while 48% of patients had an sPESI score of 0 and were thus initially considered appropriate for outpatient management.

However, the investigators recognized that no scoring system for acute PE is perfect, and that the judgment of a physician with extensive experience in managing this life-threatening condition counts for a lot. So they stipulated that a patient’s physician-in-charge could overrule a decision for early discharge. This happened 29% of the time in patients with a sPESI score of 0, as compared with a 3% overrule rate with the Hestia rule. The physician-in-charge also moved small numbers of patients who were Hestia or sPESI positive into the outpatient care group. As a result, a similar proportion of patients in both groups were discharged home within 24 hours for outpatient treatment: 38% of the total Hestia group and 37% in the sPESI arm.

Major adverse event rates were reassuringly low in both groups managed on an outpatient basis. The composite of recurrent venous thromboembolism, bleeding, or death within 30 days occurred in 1.3% of Hestia outpatients and 1.1% of sPESI outpatients. Among patients managed in the hospital, these rates were 5.6% in the Hestia group and 4.7% in the sPESI group.

Discussant Stavros V. Konstantinides, MD, who chaired the ESC guideline committee, asked rhetorically, “who’s happy with the HOME-PE trial? I think everybody.”

“The Hestia criteria integrate the feasibility of family support of the individual patient. This is a good thing. And eligibility based on the Hestia criteria, unlike sPESI, does not require age younger than 80 years or no cancer, and it appears from the HOME-PE study that this is okay,” observed Dr. Konstantinides of the Center for Thrombosis and Hemostasis at the University of Mainz (Germany).

In an interview, Hadley Wilson, MD, called the HOME-PE trial “transformative” and predicted it will change clinical practice. He was particularly impressed with the high quality of the trial, noting that 87% of participants managed as outpatients received a direct oral anticoagulant.

The Hestia rule is simpler and more user-friendly. And greater use of this triaging strategy might have advantages in terms of economics and health care utilization by potentially encouraging movement of decision-making regarding outpatient management of acute PE out of the hospital wards and into emergency departments, said Dr. Wilson, executive vice chair of the Sanger Heart and Vascular Institute and a cardiologist at the University of North Carolina at Chapel Hill.

Dr. Roy reported receiving research grants to conduct HOME-PE from the French Ministry of Health, the study sponsor. In addition, he is on scientific advisory boards and/or speakers’ panels for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Aspen, Daiichi Sankyo, and Sanofi Aventis.
 

[email protected]

The pragmatic Hestia criteria proved as safe as the more structured, points-based simplified Pulmonary Embolism Severity Index (sPESI) score for selection of patients with acute pulmonary embolism for outpatient care in the large, randomized HOME-PE trial presented at the virtual annual congress of the European Society of Cardiology.

Courtesy Wikimedia Commons/Walter Serra, Giuseppe De Iaco, Claudio Reverberi, and Tiziano Gherli/Creative Commons License

“These results support outpatient management of acute pulmonary embolism patients using either the Hestia method or the sPESI score with the option for the physician-in-charge to override the decision. In hospitals organized for outpatient management, both triaging strategies enable more than a third of pulmonary embolism patients to be managed at home with a low rate of complications,” Pierre-Marie Roy, MD, said in presenting the HOME-PE findings.

The study clarifies a transatlantic controversy regarding how best to triage patients with acute pulmonary embolism (PE) for outpatient care. The answer? It’s basically a tie between the points-based sPESI score recommended in the current ESC guidelines (Eur Respir J. 2019 Oct 9;54[3]:1901647) and the Hestia method endorsed in the American College of Chest Physician guidelines (Chest. 2016 Feb;149[2]:315-52).

The sPESI is a validated tool that grants 1 point each for age over 80 years, background cardiopulmonary disease, a systolic blood pressure below 100 mm Hg, cancer, a heart rate of 110 bpm or more, and an oxygen saturation level below 90%. A patient needs a score of zero to be eligible for outpatient management. In contrast, the Hestia method relies upon 11 simple bedside criteria rather than a points system, explained Dr. Roy of University Hospital of Angers, France (J Thromb Haemost. 2011 Aug;9[8]:1500-7).

HOME-PE was a randomized, open-label, noninferiority trial conducted at 26 hospitals in France, Belgium, Switzerland, and the Netherlands. The study included 1,974 patients presenting to the emergency department with non–high-risk acute PE as defined by hemodynamic stability. About 39% of patients in the Hestia group were eligible for outpatient care on the basis of ‘no’ answers regarding all 11 criteria, while 48% of patients had an sPESI score of 0 and were thus initially considered appropriate for outpatient management.

However, the investigators recognized that no scoring system for acute PE is perfect, and that the judgment of a physician with extensive experience in managing this life-threatening condition counts for a lot. So they stipulated that a patient’s physician-in-charge could overrule a decision for early discharge. This happened 29% of the time in patients with a sPESI score of 0, as compared with a 3% overrule rate with the Hestia rule. The physician-in-charge also moved small numbers of patients who were Hestia or sPESI positive into the outpatient care group. As a result, a similar proportion of patients in both groups were discharged home within 24 hours for outpatient treatment: 38% of the total Hestia group and 37% in the sPESI arm.

Major adverse event rates were reassuringly low in both groups managed on an outpatient basis. The composite of recurrent venous thromboembolism, bleeding, or death within 30 days occurred in 1.3% of Hestia outpatients and 1.1% of sPESI outpatients. Among patients managed in the hospital, these rates were 5.6% in the Hestia group and 4.7% in the sPESI group.

Discussant Stavros V. Konstantinides, MD, who chaired the ESC guideline committee, asked rhetorically, “who’s happy with the HOME-PE trial? I think everybody.”

“The Hestia criteria integrate the feasibility of family support of the individual patient. This is a good thing. And eligibility based on the Hestia criteria, unlike sPESI, does not require age younger than 80 years or no cancer, and it appears from the HOME-PE study that this is okay,” observed Dr. Konstantinides of the Center for Thrombosis and Hemostasis at the University of Mainz (Germany).

In an interview, Hadley Wilson, MD, called the HOME-PE trial “transformative” and predicted it will change clinical practice. He was particularly impressed with the high quality of the trial, noting that 87% of participants managed as outpatients received a direct oral anticoagulant.

The Hestia rule is simpler and more user-friendly. And greater use of this triaging strategy might have advantages in terms of economics and health care utilization by potentially encouraging movement of decision-making regarding outpatient management of acute PE out of the hospital wards and into emergency departments, said Dr. Wilson, executive vice chair of the Sanger Heart and Vascular Institute and a cardiologist at the University of North Carolina at Chapel Hill.

Dr. Roy reported receiving research grants to conduct HOME-PE from the French Ministry of Health, the study sponsor. In addition, he is on scientific advisory boards and/or speakers’ panels for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Aspen, Daiichi Sankyo, and Sanofi Aventis.
 

[email protected]

Digoxin now deserves to be considered first-line therapy for long-term heart rate control in older patients with permanent atrial fibrillation and symptoms of heart failure, Dipak Kotecha, MBChB, PhD, MSc, declared at the virtual annual congress of the European Society of Cardiology.

He presented the 12-month results of RATE-AF (Rate Control Therapy Evaluation in Permanent Atrial Fibrillation), in which 160 seniors (mean age, 76 years) with moderate or severe symptoms caused by permanent atrial fibrillation (AFib) as well as heart failure symptoms were randomized to low-dose digoxin or the beta-blocker bisoprolol for rate control.

The open-label trial was designed to address a centuries-old unmet need: “Although digoxin has been in use since 1785, we have no longer-term clinical trials of digoxin in patients with AFib or AFib with heart failure,” noted Dr. Kotecha, professor of cardiology at the University of Birmingham (England).

Not only is digoxin greatly understudied in AFib, but permanent AFib – the most common form of the arrhythmia – has received only a tiny fraction of the research attention that’s been devoted to paroxysmal or persistent AFib, he added.

In RATE-AF, digoxin and bisoprolol proved similarly effective at reducing heart rate, from about 100 bpm at baseline to the mid-70s at 6 and 12 months. Notably, only a handful of study participants required an additional rate control drug during the 12-month study. Nor did the two drugs differ in terms of their impact on patient-reported quality of life at 6 months as reflected by their Short Form–36 physical component score, the primary study endpoint. And both drugs were well tolerated, with 96% of patients in the digoxin group still on the drug at a mean of 161 mcg/day at 6 months, and 89% still on their beta-blocker.

But that’s pretty much where the similarities in outcomes ended.

For example, at 12 months, the digoxin group scored significantly higher than the beta-blocker group on several domains of the Short Form–36 physical component score, including vitality, physical function, and global health. More than half of the digoxin group had a two-class improvement in modified European Heart Rhythm Association AFib-related symptoms at 6 months, compared with 10% of the beta-blocker group. At 12 months, nearly 70% of the digoxin group had a two-class improvement, as did 30% on bisoprolol.

Heart failure symptoms in the digoxin group improved from a mean baseline New York Heart Association class of 2.4 to 1.5 at both 6 and 12 months; the improvement was more modest in the beta-blocker group, going from NYHA 2.4 at baseline to 2.0 at both 6 and 12 months. And while N-terminal of the prohormone brain natriuretic peptide levels improved in the digoxin group from a baseline of 1,095 pg/mL to 1,058 at 6 months and 960 at 12 months, NT-proBNP actually went up in the beta-blocker group, from 1,041 to 1,209-1,250 pg/mL at 12 months.

Moreover, Dr. Kotecha continued, while RATE-AF was underpowered to assess clinical events, it’s nevertheless noteworthy that a total of 29 adverse events occurred in 12 months in the digoxin group, compared with 142 with beta-blocker therapy. There were 12 unplanned hospital admissions in the digoxin group and 28 in the beta-blocker group, and 22 primary care visits for either AFib or cardiovascular symptoms in patients on digoxin versus 64 in the beta-blocker group.

“Our results suggest a wider use of digoxin for stable patients with permanent AFib,” Dr. Kotecha concluded. However, in an interview, Jonathan Piccini, MD, had a different take on the study results.

“I don’t think this study should widely impact clinical practice in the U.S.,” according to Dr. Piccini, director of cardiac electrophysiology at Duke University, Durham, N.C.

His reservations included RATE-AF’s modest sample size as well as uncertainty as to the trial’s generalizability, given that bisoprolol isn’t much used in the United States. Also, these were elderly patients with shortness of breath, and it’s unclear how effective digoxin would be for rate control in patients with permanent AFib who are more active.

“The classic teaching is that digoxin is great for rate control at rest, but when people are active it’s not nearly as good as beta-blockers or calcium-channel blockers,” the cardiologist said.

“A beta-blocker is still going to be my first-line rate control agent. But the results of RATE-AF do open my mind that for an older sedentary patient I may very well think twice now about using digoxin, because in that situation it looks like it achieves similar goals as a beta-blocker,” Dr. Piccini added.

On the plus side for RATE-AF: “I am very pleased to see that we have a randomized controlled trial focused on rate control in permanent AFib. It also tickles me pink to see a randomized, controlled study of digoxin. And I’m really excited to see a clinical trial that focuses on quality of life. It should give some confidence to know that from a quality of life perspective clinicians can consider using either digoxin or a beta-blocker for rate control,” he said.

American College of Cardiology vice president Dipti Itchhaporia, MD, said she’d need to see a much larger randomized trial including a calcium-channel blocker as a third-rate control arm before she’d consider digoxin as first-line rate control therapy in patients with AFib with or without heart failure. Also, she has reservations about drawing definitive conclusions from an open, unblinded study in which patient-reported outcomes are the primary endpoint.

“I think these were surprising findings given what we all think about digoxin in this country. In general, digoxin fell out of favor for rate control, mainly because of observational studies showing increased mortality. So most of us choose a beta-blocker,” she observed in an interview.

But of course, a randomized trial, even a 160-patient randomized trial, constitutes a higher level of evidence.

“I don’t think I’m going to convert tomorrow and make digoxin my first-line rate control therapy without more data. But RATE-AF does makes me stop and think about using it more than I did before in some of my permanent AFib patients,” said Dr. Itchhaporia, director of disease management at Hoag Memorial Hospital in Newport Beach, Calif.

Dr. Kotecha reported having no financial conflicts regarding the study, which was funded by the U.K. National Institute for Health Research, the British Heart Foundation, and the European Union.

[email protected]

Digoxin now deserves to be considered first-line therapy for long-term heart rate control in older patients with permanent atrial fibrillation and symptoms of heart failure, Dipak Kotecha, MBChB, PhD, MSc, declared at the virtual annual congress of the European Society of Cardiology.

He presented the 12-month results of RATE-AF (Rate Control Therapy Evaluation in Permanent Atrial Fibrillation), in which 160 seniors (mean age, 76 years) with moderate or severe symptoms caused by permanent atrial fibrillation (AFib) as well as heart failure symptoms were randomized to low-dose digoxin or the beta-blocker bisoprolol for rate control.

The open-label trial was designed to address a centuries-old unmet need: “Although digoxin has been in use since 1785, we have no longer-term clinical trials of digoxin in patients with AFib or AFib with heart failure,” noted Dr. Kotecha, professor of cardiology at the University of Birmingham (England).

Not only is digoxin greatly understudied in AFib, but permanent AFib – the most common form of the arrhythmia – has received only a tiny fraction of the research attention that’s been devoted to paroxysmal or persistent AFib, he added.

In RATE-AF, digoxin and bisoprolol proved similarly effective at reducing heart rate, from about 100 bpm at baseline to the mid-70s at 6 and 12 months. Notably, only a handful of study participants required an additional rate control drug during the 12-month study. Nor did the two drugs differ in terms of their impact on patient-reported quality of life at 6 months as reflected by their Short Form–36 physical component score, the primary study endpoint. And both drugs were well tolerated, with 96% of patients in the digoxin group still on the drug at a mean of 161 mcg/day at 6 months, and 89% still on their beta-blocker.

But that’s pretty much where the similarities in outcomes ended.

For example, at 12 months, the digoxin group scored significantly higher than the beta-blocker group on several domains of the Short Form–36 physical component score, including vitality, physical function, and global health. More than half of the digoxin group had a two-class improvement in modified European Heart Rhythm Association AFib-related symptoms at 6 months, compared with 10% of the beta-blocker group. At 12 months, nearly 70% of the digoxin group had a two-class improvement, as did 30% on bisoprolol.

Heart failure symptoms in the digoxin group improved from a mean baseline New York Heart Association class of 2.4 to 1.5 at both 6 and 12 months; the improvement was more modest in the beta-blocker group, going from NYHA 2.4 at baseline to 2.0 at both 6 and 12 months. And while N-terminal of the prohormone brain natriuretic peptide levels improved in the digoxin group from a baseline of 1,095 pg/mL to 1,058 at 6 months and 960 at 12 months, NT-proBNP actually went up in the beta-blocker group, from 1,041 to 1,209-1,250 pg/mL at 12 months.

Moreover, Dr. Kotecha continued, while RATE-AF was underpowered to assess clinical events, it’s nevertheless noteworthy that a total of 29 adverse events occurred in 12 months in the digoxin group, compared with 142 with beta-blocker therapy. There were 12 unplanned hospital admissions in the digoxin group and 28 in the beta-blocker group, and 22 primary care visits for either AFib or cardiovascular symptoms in patients on digoxin versus 64 in the beta-blocker group.

“Our results suggest a wider use of digoxin for stable patients with permanent AFib,” Dr. Kotecha concluded. However, in an interview, Jonathan Piccini, MD, had a different take on the study results.

“I don’t think this study should widely impact clinical practice in the U.S.,” according to Dr. Piccini, director of cardiac electrophysiology at Duke University, Durham, N.C.

His reservations included RATE-AF’s modest sample size as well as uncertainty as to the trial’s generalizability, given that bisoprolol isn’t much used in the United States. Also, these were elderly patients with shortness of breath, and it’s unclear how effective digoxin would be for rate control in patients with permanent AFib who are more active.

“The classic teaching is that digoxin is great for rate control at rest, but when people are active it’s not nearly as good as beta-blockers or calcium-channel blockers,” the cardiologist said.

“A beta-blocker is still going to be my first-line rate control agent. But the results of RATE-AF do open my mind that for an older sedentary patient I may very well think twice now about using digoxin, because in that situation it looks like it achieves similar goals as a beta-blocker,” Dr. Piccini added.

On the plus side for RATE-AF: “I am very pleased to see that we have a randomized controlled trial focused on rate control in permanent AFib. It also tickles me pink to see a randomized, controlled study of digoxin. And I’m really excited to see a clinical trial that focuses on quality of life. It should give some confidence to know that from a quality of life perspective clinicians can consider using either digoxin or a beta-blocker for rate control,” he said.

American College of Cardiology vice president Dipti Itchhaporia, MD, said she’d need to see a much larger randomized trial including a calcium-channel blocker as a third-rate control arm before she’d consider digoxin as first-line rate control therapy in patients with AFib with or without heart failure. Also, she has reservations about drawing definitive conclusions from an open, unblinded study in which patient-reported outcomes are the primary endpoint.

“I think these were surprising findings given what we all think about digoxin in this country. In general, digoxin fell out of favor for rate control, mainly because of observational studies showing increased mortality. So most of us choose a beta-blocker,” she observed in an interview.

But of course, a randomized trial, even a 160-patient randomized trial, constitutes a higher level of evidence.

“I don’t think I’m going to convert tomorrow and make digoxin my first-line rate control therapy without more data. But RATE-AF does makes me stop and think about using it more than I did before in some of my permanent AFib patients,” said Dr. Itchhaporia, director of disease management at Hoag Memorial Hospital in Newport Beach, Calif.

Dr. Kotecha reported having no financial conflicts regarding the study, which was funded by the U.K. National Institute for Health Research, the British Heart Foundation, and the European Union.

[email protected]

Digoxin now deserves to be considered first-line therapy for long-term heart rate control in older patients with permanent atrial fibrillation and symptoms of heart failure, Dipak Kotecha, MBChB, PhD, MSc, declared at the virtual annual congress of the European Society of Cardiology.

He presented the 12-month results of RATE-AF (Rate Control Therapy Evaluation in Permanent Atrial Fibrillation), in which 160 seniors (mean age, 76 years) with moderate or severe symptoms caused by permanent atrial fibrillation (AFib) as well as heart failure symptoms were randomized to low-dose digoxin or the beta-blocker bisoprolol for rate control.

The open-label trial was designed to address a centuries-old unmet need: “Although digoxin has been in use since 1785, we have no longer-term clinical trials of digoxin in patients with AFib or AFib with heart failure,” noted Dr. Kotecha, professor of cardiology at the University of Birmingham (England).

Not only is digoxin greatly understudied in AFib, but permanent AFib – the most common form of the arrhythmia – has received only a tiny fraction of the research attention that’s been devoted to paroxysmal or persistent AFib, he added.

In RATE-AF, digoxin and bisoprolol proved similarly effective at reducing heart rate, from about 100 bpm at baseline to the mid-70s at 6 and 12 months. Notably, only a handful of study participants required an additional rate control drug during the 12-month study. Nor did the two drugs differ in terms of their impact on patient-reported quality of life at 6 months as reflected by their Short Form–36 physical component score, the primary study endpoint. And both drugs were well tolerated, with 96% of patients in the digoxin group still on the drug at a mean of 161 mcg/day at 6 months, and 89% still on their beta-blocker.

But that’s pretty much where the similarities in outcomes ended.

For example, at 12 months, the digoxin group scored significantly higher than the beta-blocker group on several domains of the Short Form–36 physical component score, including vitality, physical function, and global health. More than half of the digoxin group had a two-class improvement in modified European Heart Rhythm Association AFib-related symptoms at 6 months, compared with 10% of the beta-blocker group. At 12 months, nearly 70% of the digoxin group had a two-class improvement, as did 30% on bisoprolol.

Heart failure symptoms in the digoxin group improved from a mean baseline New York Heart Association class of 2.4 to 1.5 at both 6 and 12 months; the improvement was more modest in the beta-blocker group, going from NYHA 2.4 at baseline to 2.0 at both 6 and 12 months. And while N-terminal of the prohormone brain natriuretic peptide levels improved in the digoxin group from a baseline of 1,095 pg/mL to 1,058 at 6 months and 960 at 12 months, NT-proBNP actually went up in the beta-blocker group, from 1,041 to 1,209-1,250 pg/mL at 12 months.

Moreover, Dr. Kotecha continued, while RATE-AF was underpowered to assess clinical events, it’s nevertheless noteworthy that a total of 29 adverse events occurred in 12 months in the digoxin group, compared with 142 with beta-blocker therapy. There were 12 unplanned hospital admissions in the digoxin group and 28 in the beta-blocker group, and 22 primary care visits for either AFib or cardiovascular symptoms in patients on digoxin versus 64 in the beta-blocker group.

“Our results suggest a wider use of digoxin for stable patients with permanent AFib,” Dr. Kotecha concluded. However, in an interview, Jonathan Piccini, MD, had a different take on the study results.

“I don’t think this study should widely impact clinical practice in the U.S.,” according to Dr. Piccini, director of cardiac electrophysiology at Duke University, Durham, N.C.

His reservations included RATE-AF’s modest sample size as well as uncertainty as to the trial’s generalizability, given that bisoprolol isn’t much used in the United States. Also, these were elderly patients with shortness of breath, and it’s unclear how effective digoxin would be for rate control in patients with permanent AFib who are more active.

“The classic teaching is that digoxin is great for rate control at rest, but when people are active it’s not nearly as good as beta-blockers or calcium-channel blockers,” the cardiologist said.

“A beta-blocker is still going to be my first-line rate control agent. But the results of RATE-AF do open my mind that for an older sedentary patient I may very well think twice now about using digoxin, because in that situation it looks like it achieves similar goals as a beta-blocker,” Dr. Piccini added.

On the plus side for RATE-AF: “I am very pleased to see that we have a randomized controlled trial focused on rate control in permanent AFib. It also tickles me pink to see a randomized, controlled study of digoxin. And I’m really excited to see a clinical trial that focuses on quality of life. It should give some confidence to know that from a quality of life perspective clinicians can consider using either digoxin or a beta-blocker for rate control,” he said.

American College of Cardiology vice president Dipti Itchhaporia, MD, said she’d need to see a much larger randomized trial including a calcium-channel blocker as a third-rate control arm before she’d consider digoxin as first-line rate control therapy in patients with AFib with or without heart failure. Also, she has reservations about drawing definitive conclusions from an open, unblinded study in which patient-reported outcomes are the primary endpoint.

“I think these were surprising findings given what we all think about digoxin in this country. In general, digoxin fell out of favor for rate control, mainly because of observational studies showing increased mortality. So most of us choose a beta-blocker,” she observed in an interview.

But of course, a randomized trial, even a 160-patient randomized trial, constitutes a higher level of evidence.

“I don’t think I’m going to convert tomorrow and make digoxin my first-line rate control therapy without more data. But RATE-AF does makes me stop and think about using it more than I did before in some of my permanent AFib patients,” said Dr. Itchhaporia, director of disease management at Hoag Memorial Hospital in Newport Beach, Calif.

Dr. Kotecha reported having no financial conflicts regarding the study, which was funded by the U.K. National Institute for Health Research, the British Heart Foundation, and the European Union.

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