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Pain 1 year after MI tied to all-cause mortality
, new research suggests.
In the analysis of post-MI health data for more than 18,300 Swedish adults, those with moderate pain were 35% more likely to die from any cause during follow-up, compared with those with no pain, and those with extreme pain were more than twice as likely to die.
Furthermore, pain was a stronger predictor of mortality than smoking.
“For a long time, pain has been regarded as merely a symptom of disease rather than a disease” in its own right, Linda Vixner, PT, PhD, of Dalarna University in Falun, Sweden, said in an interview.
Updated definitions of chronic pain in the ICD-11, as well as a recent study using data from the UK Biobank showing that chronic pain is associated with an increased risk of cardiovascular disease, prompted the current study, which looks at the effect of pain on long-term survival after an MI.
“We did not expect that pain would have such a strong impact on the risk of death, and it also surprised us that the risk was more pronounced than that of smoking,” Dr. Vixner said. “Clinicians should consider pain an important cardiovascular risk factor.”
The study was published online in the Journal of the American Heart Association.
‘Experienced pain’ prognostic
The investigators analyzed data from the SWEDEHEART registry of 18,376 patients who had an MI in 2004-2013. The mean age of patients was 62 years and 75% were men. Follow-up time was 8.5 years (median, 3.37).
Self-reported levels of experienced pain according to the EuroQol five-dimension instrument were recorded 12 months after hospital discharge.
Moderate pain was reported by 38.2% of patients and extreme pain by 4.5%.
In the extreme pain category, women were overrepresented (7.5% vs. 3.6% of men), as were current smokers, and patients with diabetes, previous MI, previous stroke, previous percutaneous coronary intervention, non-ST-segment–elevation MI, and any kind of chest pain. Patients classified as physically inactive also were overrepresented in this category.
In addition, those with extreme pain had a higher body mass index and waist circumference 12 months after hospital discharge.
Most (73%) of the 7,889 patients who reported no pain at the 2-month follow-up after MI were also pain-free at the 12-month follow-up, and 65% of those experiencing pain at 2 months were also experiencing pain at 12 months.
There were 1,067 deaths. The adjusted hazard ratio was 1.35 for moderate pain and 2.06 for extreme pain.
As noted, pain was a stronger mortality predictor than smoking: C-statistics for pain were 0.60, and for smoking, 0.55.
“Clinicians managing patients after MI should recognize the need to consider experienced pain as a prognostic factor comparable to persistent smoking and to address this when designing individually adjusted [cardiac rehabilitation] and secondary prevention treatments,” the authors write.
Pain should be assessed at follow-up after MI, they add, and, as Dr. Vixner suggested, it should be “acknowledged as an important risk factor.”
Managing risks
“These findings parallel prior studies and my own clinical experience,” American Heart Association volunteer expert Gregg C. Fonarow, MD, interim chief of the division of cardiology at the University of California, Los Angeles, and director, Ahmanson-UCLA Cardiomyopathy Center, told this news organization.
“There are many potential causes for patient-reported pain in the year after a heart attack,” he said, including a greater cardiovascular risk burden, more comorbid conditions, less physical activity, and chronic use of nonsteroidal anti-inflammatory medications or opioids for pain control – all of which can contribute to the increased risk of mortality.
Factors beyond those evaluated and adjusted for in the observational study may contribute to the observed associations, he added. “Socioeconomic factors were not accounted for [and] there was no information on the types, doses, and frequency of pain medication use.”
“Clinicians managing patients with prior MI should carefully assess experienced pain and utilize this information to optimize risk factor control recommendations, inform treatment decisions, and consider in terms of prognosis,” he advised.
Further studies should evaluate whether the associations hold true for other patient populations, Dr. Fonarow said. “In addition, intervention trials could evaluate if enhanced management strategies in these higher-risk patients with self-reported pain can successfully lower the mortality risk.”
Dr. Vixner sees a role for physical activity in lowering the mortality risk.
“One of the core treatments for chronic pain is physical activity,” she said. “It positively influences quality of life, activities of daily living, pain intensity, and overall physical function, and reduces the risk of social isolation” and cardiovascular diseases.
Her team recently developed the “eVISualisation of physical activity and pain” (eVIS) intervention, which aims to promote healthy physical activity levels in persons living with chronic pain. The intervention is currently being evaluated in an ongoing registry-based, randomized controlled trial.
The study was supported by Svenska Försäkringsföreningen, Dalarna University, Region Dalarna. Dr. Vixner and coauthors have reported no relevant financial relationships. Dr. Fonarow has disclosed consulting for Abbott, Amgen, AstraZeneca, Bayer, Cytokinetics, Eli Lilly, Johnson & Johnson, Medtronic, Merck, Novartis, and Pfizer.
A version of this article first appeared on Medscape.com.
, new research suggests.
In the analysis of post-MI health data for more than 18,300 Swedish adults, those with moderate pain were 35% more likely to die from any cause during follow-up, compared with those with no pain, and those with extreme pain were more than twice as likely to die.
Furthermore, pain was a stronger predictor of mortality than smoking.
“For a long time, pain has been regarded as merely a symptom of disease rather than a disease” in its own right, Linda Vixner, PT, PhD, of Dalarna University in Falun, Sweden, said in an interview.
Updated definitions of chronic pain in the ICD-11, as well as a recent study using data from the UK Biobank showing that chronic pain is associated with an increased risk of cardiovascular disease, prompted the current study, which looks at the effect of pain on long-term survival after an MI.
“We did not expect that pain would have such a strong impact on the risk of death, and it also surprised us that the risk was more pronounced than that of smoking,” Dr. Vixner said. “Clinicians should consider pain an important cardiovascular risk factor.”
The study was published online in the Journal of the American Heart Association.
‘Experienced pain’ prognostic
The investigators analyzed data from the SWEDEHEART registry of 18,376 patients who had an MI in 2004-2013. The mean age of patients was 62 years and 75% were men. Follow-up time was 8.5 years (median, 3.37).
Self-reported levels of experienced pain according to the EuroQol five-dimension instrument were recorded 12 months after hospital discharge.
Moderate pain was reported by 38.2% of patients and extreme pain by 4.5%.
In the extreme pain category, women were overrepresented (7.5% vs. 3.6% of men), as were current smokers, and patients with diabetes, previous MI, previous stroke, previous percutaneous coronary intervention, non-ST-segment–elevation MI, and any kind of chest pain. Patients classified as physically inactive also were overrepresented in this category.
In addition, those with extreme pain had a higher body mass index and waist circumference 12 months after hospital discharge.
Most (73%) of the 7,889 patients who reported no pain at the 2-month follow-up after MI were also pain-free at the 12-month follow-up, and 65% of those experiencing pain at 2 months were also experiencing pain at 12 months.
There were 1,067 deaths. The adjusted hazard ratio was 1.35 for moderate pain and 2.06 for extreme pain.
As noted, pain was a stronger mortality predictor than smoking: C-statistics for pain were 0.60, and for smoking, 0.55.
“Clinicians managing patients after MI should recognize the need to consider experienced pain as a prognostic factor comparable to persistent smoking and to address this when designing individually adjusted [cardiac rehabilitation] and secondary prevention treatments,” the authors write.
Pain should be assessed at follow-up after MI, they add, and, as Dr. Vixner suggested, it should be “acknowledged as an important risk factor.”
Managing risks
“These findings parallel prior studies and my own clinical experience,” American Heart Association volunteer expert Gregg C. Fonarow, MD, interim chief of the division of cardiology at the University of California, Los Angeles, and director, Ahmanson-UCLA Cardiomyopathy Center, told this news organization.
“There are many potential causes for patient-reported pain in the year after a heart attack,” he said, including a greater cardiovascular risk burden, more comorbid conditions, less physical activity, and chronic use of nonsteroidal anti-inflammatory medications or opioids for pain control – all of which can contribute to the increased risk of mortality.
Factors beyond those evaluated and adjusted for in the observational study may contribute to the observed associations, he added. “Socioeconomic factors were not accounted for [and] there was no information on the types, doses, and frequency of pain medication use.”
“Clinicians managing patients with prior MI should carefully assess experienced pain and utilize this information to optimize risk factor control recommendations, inform treatment decisions, and consider in terms of prognosis,” he advised.
Further studies should evaluate whether the associations hold true for other patient populations, Dr. Fonarow said. “In addition, intervention trials could evaluate if enhanced management strategies in these higher-risk patients with self-reported pain can successfully lower the mortality risk.”
Dr. Vixner sees a role for physical activity in lowering the mortality risk.
“One of the core treatments for chronic pain is physical activity,” she said. “It positively influences quality of life, activities of daily living, pain intensity, and overall physical function, and reduces the risk of social isolation” and cardiovascular diseases.
Her team recently developed the “eVISualisation of physical activity and pain” (eVIS) intervention, which aims to promote healthy physical activity levels in persons living with chronic pain. The intervention is currently being evaluated in an ongoing registry-based, randomized controlled trial.
The study was supported by Svenska Försäkringsföreningen, Dalarna University, Region Dalarna. Dr. Vixner and coauthors have reported no relevant financial relationships. Dr. Fonarow has disclosed consulting for Abbott, Amgen, AstraZeneca, Bayer, Cytokinetics, Eli Lilly, Johnson & Johnson, Medtronic, Merck, Novartis, and Pfizer.
A version of this article first appeared on Medscape.com.
, new research suggests.
In the analysis of post-MI health data for more than 18,300 Swedish adults, those with moderate pain were 35% more likely to die from any cause during follow-up, compared with those with no pain, and those with extreme pain were more than twice as likely to die.
Furthermore, pain was a stronger predictor of mortality than smoking.
“For a long time, pain has been regarded as merely a symptom of disease rather than a disease” in its own right, Linda Vixner, PT, PhD, of Dalarna University in Falun, Sweden, said in an interview.
Updated definitions of chronic pain in the ICD-11, as well as a recent study using data from the UK Biobank showing that chronic pain is associated with an increased risk of cardiovascular disease, prompted the current study, which looks at the effect of pain on long-term survival after an MI.
“We did not expect that pain would have such a strong impact on the risk of death, and it also surprised us that the risk was more pronounced than that of smoking,” Dr. Vixner said. “Clinicians should consider pain an important cardiovascular risk factor.”
The study was published online in the Journal of the American Heart Association.
‘Experienced pain’ prognostic
The investigators analyzed data from the SWEDEHEART registry of 18,376 patients who had an MI in 2004-2013. The mean age of patients was 62 years and 75% were men. Follow-up time was 8.5 years (median, 3.37).
Self-reported levels of experienced pain according to the EuroQol five-dimension instrument were recorded 12 months after hospital discharge.
Moderate pain was reported by 38.2% of patients and extreme pain by 4.5%.
In the extreme pain category, women were overrepresented (7.5% vs. 3.6% of men), as were current smokers, and patients with diabetes, previous MI, previous stroke, previous percutaneous coronary intervention, non-ST-segment–elevation MI, and any kind of chest pain. Patients classified as physically inactive also were overrepresented in this category.
In addition, those with extreme pain had a higher body mass index and waist circumference 12 months after hospital discharge.
Most (73%) of the 7,889 patients who reported no pain at the 2-month follow-up after MI were also pain-free at the 12-month follow-up, and 65% of those experiencing pain at 2 months were also experiencing pain at 12 months.
There were 1,067 deaths. The adjusted hazard ratio was 1.35 for moderate pain and 2.06 for extreme pain.
As noted, pain was a stronger mortality predictor than smoking: C-statistics for pain were 0.60, and for smoking, 0.55.
“Clinicians managing patients after MI should recognize the need to consider experienced pain as a prognostic factor comparable to persistent smoking and to address this when designing individually adjusted [cardiac rehabilitation] and secondary prevention treatments,” the authors write.
Pain should be assessed at follow-up after MI, they add, and, as Dr. Vixner suggested, it should be “acknowledged as an important risk factor.”
Managing risks
“These findings parallel prior studies and my own clinical experience,” American Heart Association volunteer expert Gregg C. Fonarow, MD, interim chief of the division of cardiology at the University of California, Los Angeles, and director, Ahmanson-UCLA Cardiomyopathy Center, told this news organization.
“There are many potential causes for patient-reported pain in the year after a heart attack,” he said, including a greater cardiovascular risk burden, more comorbid conditions, less physical activity, and chronic use of nonsteroidal anti-inflammatory medications or opioids for pain control – all of which can contribute to the increased risk of mortality.
Factors beyond those evaluated and adjusted for in the observational study may contribute to the observed associations, he added. “Socioeconomic factors were not accounted for [and] there was no information on the types, doses, and frequency of pain medication use.”
“Clinicians managing patients with prior MI should carefully assess experienced pain and utilize this information to optimize risk factor control recommendations, inform treatment decisions, and consider in terms of prognosis,” he advised.
Further studies should evaluate whether the associations hold true for other patient populations, Dr. Fonarow said. “In addition, intervention trials could evaluate if enhanced management strategies in these higher-risk patients with self-reported pain can successfully lower the mortality risk.”
Dr. Vixner sees a role for physical activity in lowering the mortality risk.
“One of the core treatments for chronic pain is physical activity,” she said. “It positively influences quality of life, activities of daily living, pain intensity, and overall physical function, and reduces the risk of social isolation” and cardiovascular diseases.
Her team recently developed the “eVISualisation of physical activity and pain” (eVIS) intervention, which aims to promote healthy physical activity levels in persons living with chronic pain. The intervention is currently being evaluated in an ongoing registry-based, randomized controlled trial.
The study was supported by Svenska Försäkringsföreningen, Dalarna University, Region Dalarna. Dr. Vixner and coauthors have reported no relevant financial relationships. Dr. Fonarow has disclosed consulting for Abbott, Amgen, AstraZeneca, Bayer, Cytokinetics, Eli Lilly, Johnson & Johnson, Medtronic, Merck, Novartis, and Pfizer.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN HEART ASSOCIATION
Step counts under 5,000 still tied to lower mortality risk
in a new meta-analysis.
More steps were better – additional benefit was seen with increasing increments of 500 or 1,000 steps.
“One of our main aims was to overcome all the inconsistencies in previous studies, where the optimal number of daily steps for health benefits was usually between 6,000 and 10,000,” Maciej Banach, MD, PhD, of the Medical University of Lodz (Poland), said in an interview.
“As a preventive cardiologist, I saw that many of my patients were discouraged and said it’s impossible when I told them that making lifestyle changes included taking at least 7,000 daily steps,” he said.
“But our study in relatively healthy individuals, not patients, showed even a lower number – for example, around 4,000 – may be associated with a significant reduction of mortality.
“I tell people to start early, be regular, and don’t worry about the initial baseline number, because it’s important to start and it’s important to improve,” he said. “Our study showed that if we increase the number of steps per day, every 500- to 1,000-step increase might still be associated with an additional mortality reduction of 7%-15%.”
The study was published online in the European Journal of Preventive Cardiology.
Every move counts
The investigators searched the literature through June 2022 and selected 17 cohort studies with 226,889 participants and a median follow-up of 7.1 years for inclusion in the analysis: 10 studies reported all-cause mortality, 4 reported CV mortality, and 3 reported both outcomes.
The mean age of the participants was 64.4 years, and half were women. Daily step counts in the included studies were objectively measured for at least 7 consecutive days.
As noted, a 1,000-step increment was associated with a 15% decrease in risk of all-cause mortality (hazard ratio, 0.85); a 500-step increment was associated with a 7% decrease in CV mortality (HR, 0.93).
Compared with the reference quartile (median steps/day, 3,967), quartile 1 (median steps, 5,537) was associated with a 48% lower risk of all-cause mortality; quartile 2 (median steps, 7,370), with a 55% lower risk; and quartile 3 (median steps, 11,529), with a 67% risk reduction.
Similarly, compared with the lowest quartile of steps per day used as reference (median steps, 2,337), higher quartiles of steps per day (Q1, 3,982; Q2, 6,661; and Q3, 10,413) were linearly associated with a reduced risk of CV mortality (16%, 49%, and 77%, respectively).
In a restricted cubic splines model, a nonlinear dose-response association was observed between step count and all-cause and CV mortality, with a progressively lower risk of mortality with an increase in step count.
Dose-response curves were similar for men and women. However, there was a difference by age: Among people aged 60 years or older, the size of the risk reduction was smaller. Among the older adults, there was a 42% risk reduction for those who walked between 6000 and 10,000 steps daily, compared with a 49% reduction in risk among younger adults who walked between 7,000 and 13,000 steps a day.
For both groups, daily step counts higher than 5,000 resulted in a “dramatically” lower risk of all-cause mortality.
An analysis that compared the impact of climate regions on the associations showed no significant effect on all-cause mortality. People in all climate zones benefited when the daily step count exceeded approximately 5,500.
Even given the encouraging study results, “we know very well that every kind of exercise is critically important,” Dr. Banach said. It is easier to focus on step counts because the counts can be monitored and calculated with smartwatches, pedometers, and other tools. That also makes it easier to check associations and outcomes for large groups of patients.
“But in fact, we should not be focusing on one type of exercise, such as walking or running,” he said. “We can dance, ride bicycles, and do many other different exercises that mobilize our hearts.
“We also know that in all these activities, including steps, people have different capabilities – for example, some can walk more slowly, others faster and with more intensity.”
Dr. Banach recommended following the European and U.S. physical activity guidelines that advise, in addition to muscle-strengthening activities, 150 minutes of moderate-intensity aerobic training weekly, or 75 minutes of vigorous-intensity aerobic activity, or an equivalent combination of moderate- and vigorous-intensity aerobic activity.
From the results he sees in patients, he believes the combination approach is probably best for the heart.
Furthermore, it’s important to exercise regularly, something that’s easier if individuals enjoy what they’re doing. “The type of training or whether you are completely inactive or very active at the start doesn’t matter, because any improvement, any addition to the to the baseline values will have health benefits,” he concluded.
Higher goals helpful
Three experts commented on the study; all noted that the results are in line with previous studies, that the observational nature of the study is a limitation, and that additional randomized, controlled trials are needed to confirm the findings.
Evan Brittain, MD, an associate professor of medicine at Vanderbilt University Medical Center, Nashville, Tenn., expressed some additional concerns.
Dr. Brittain was principal investigator of a recent study that found that the relationship between steps per day and incident disease was inverse and linear for obesity, sleep apnea, gastroesophageal reflux disease, and major depressive disorder. Daily step counts above 8,200 were associated with protection from incident disease.
He noted that, in the current study, “the authors chose to make the least active quartile (25%) the reference group (only 3,967 steps/day for all-cause mortality and only 2,337 steps/day for CV mortality analysis), which somewhat lowers the bar for finding a significant benefit at higher step counts.
“Moreover, in the spline analyses, zero steps per day is used as the comparison, which is not a practical, real-world comparison,” he said. “As a result, those data are very hard to interpret, and I think are overstated.”
Like Dr. Banach, Dr. Brittain said he would continue to advise following guideline recommendations to get 150 minutes per week of moderate-intensity activity. However, he added that although it is reasonable to advise patients that benefits do accrue with daily step counts of less than 10,000, “I would not want patients to misconstrue from this study that getting more than only 2,330 steps per day is a beneficial goal.”
Martin Halle, MD, a professor in the department of prevention and sports medicine at the Technical University of Munich (Germany), said: “From a clinical, medical, and health perspective, the general population should aim for 5,000 steps, which is about 3-4 kilometers [about 2 miles] of walking, and intensity counts – the faster you walk, the better.
“I recommend doing 100 steps fast and 100 steps slow and then 100 steps fast and 100 steps slow,” said Dr. Halle, who is past president of the European Association of Preventive Cardiology. This approach not only motivates people, “but they improve their exercise capacity substantially and very quickly, just within weeks.”
European Society of Cardiology vice president and European Journal of Preventive Cardiology editor-in-chief Massimo Piepoli, MD, PhD, agreed that “little is better than nothing and more is even better. This applies to healthy subjects, as well as patients with chronic diseases.
“Five hundred steps is a very short distance (such as walking two blocks or walking the dog for about 10-15 minutes every day),” he said. Yet, increasing step counts in increments of 500 “is associated with a significant reduction in cardiovascular mortality both in men and women, particularly in older individuals.
“We do not need to depend on expensive gym facilities,” he added. “But at the same time, we need to live in and to promote the building of neighborhoods where it is possible to walk in a safe and healthy environment.”
The research received no external funding. Dr. Banach has reported financial relationships with Amgen, Daiichi Sankyo, Esperion, Freia Pharmaceuticals, Kogen, KRKA, Polpharma, NewAmsterdam, Novartis, Novo Nordisk, Polfarmex, Sanofi Aventis, Teva, Valeant, Viatris, and Zentiva, and is chief marketing and development officer at Longevity Group and chief marketing officer at Nomi Biotech.
A version of this article first appeared on Medscape.com.
in a new meta-analysis.
More steps were better – additional benefit was seen with increasing increments of 500 or 1,000 steps.
“One of our main aims was to overcome all the inconsistencies in previous studies, where the optimal number of daily steps for health benefits was usually between 6,000 and 10,000,” Maciej Banach, MD, PhD, of the Medical University of Lodz (Poland), said in an interview.
“As a preventive cardiologist, I saw that many of my patients were discouraged and said it’s impossible when I told them that making lifestyle changes included taking at least 7,000 daily steps,” he said.
“But our study in relatively healthy individuals, not patients, showed even a lower number – for example, around 4,000 – may be associated with a significant reduction of mortality.
“I tell people to start early, be regular, and don’t worry about the initial baseline number, because it’s important to start and it’s important to improve,” he said. “Our study showed that if we increase the number of steps per day, every 500- to 1,000-step increase might still be associated with an additional mortality reduction of 7%-15%.”
The study was published online in the European Journal of Preventive Cardiology.
Every move counts
The investigators searched the literature through June 2022 and selected 17 cohort studies with 226,889 participants and a median follow-up of 7.1 years for inclusion in the analysis: 10 studies reported all-cause mortality, 4 reported CV mortality, and 3 reported both outcomes.
The mean age of the participants was 64.4 years, and half were women. Daily step counts in the included studies were objectively measured for at least 7 consecutive days.
As noted, a 1,000-step increment was associated with a 15% decrease in risk of all-cause mortality (hazard ratio, 0.85); a 500-step increment was associated with a 7% decrease in CV mortality (HR, 0.93).
Compared with the reference quartile (median steps/day, 3,967), quartile 1 (median steps, 5,537) was associated with a 48% lower risk of all-cause mortality; quartile 2 (median steps, 7,370), with a 55% lower risk; and quartile 3 (median steps, 11,529), with a 67% risk reduction.
Similarly, compared with the lowest quartile of steps per day used as reference (median steps, 2,337), higher quartiles of steps per day (Q1, 3,982; Q2, 6,661; and Q3, 10,413) were linearly associated with a reduced risk of CV mortality (16%, 49%, and 77%, respectively).
In a restricted cubic splines model, a nonlinear dose-response association was observed between step count and all-cause and CV mortality, with a progressively lower risk of mortality with an increase in step count.
Dose-response curves were similar for men and women. However, there was a difference by age: Among people aged 60 years or older, the size of the risk reduction was smaller. Among the older adults, there was a 42% risk reduction for those who walked between 6000 and 10,000 steps daily, compared with a 49% reduction in risk among younger adults who walked between 7,000 and 13,000 steps a day.
For both groups, daily step counts higher than 5,000 resulted in a “dramatically” lower risk of all-cause mortality.
An analysis that compared the impact of climate regions on the associations showed no significant effect on all-cause mortality. People in all climate zones benefited when the daily step count exceeded approximately 5,500.
Even given the encouraging study results, “we know very well that every kind of exercise is critically important,” Dr. Banach said. It is easier to focus on step counts because the counts can be monitored and calculated with smartwatches, pedometers, and other tools. That also makes it easier to check associations and outcomes for large groups of patients.
“But in fact, we should not be focusing on one type of exercise, such as walking or running,” he said. “We can dance, ride bicycles, and do many other different exercises that mobilize our hearts.
“We also know that in all these activities, including steps, people have different capabilities – for example, some can walk more slowly, others faster and with more intensity.”
Dr. Banach recommended following the European and U.S. physical activity guidelines that advise, in addition to muscle-strengthening activities, 150 minutes of moderate-intensity aerobic training weekly, or 75 minutes of vigorous-intensity aerobic activity, or an equivalent combination of moderate- and vigorous-intensity aerobic activity.
From the results he sees in patients, he believes the combination approach is probably best for the heart.
Furthermore, it’s important to exercise regularly, something that’s easier if individuals enjoy what they’re doing. “The type of training or whether you are completely inactive or very active at the start doesn’t matter, because any improvement, any addition to the to the baseline values will have health benefits,” he concluded.
Higher goals helpful
Three experts commented on the study; all noted that the results are in line with previous studies, that the observational nature of the study is a limitation, and that additional randomized, controlled trials are needed to confirm the findings.
Evan Brittain, MD, an associate professor of medicine at Vanderbilt University Medical Center, Nashville, Tenn., expressed some additional concerns.
Dr. Brittain was principal investigator of a recent study that found that the relationship between steps per day and incident disease was inverse and linear for obesity, sleep apnea, gastroesophageal reflux disease, and major depressive disorder. Daily step counts above 8,200 were associated with protection from incident disease.
He noted that, in the current study, “the authors chose to make the least active quartile (25%) the reference group (only 3,967 steps/day for all-cause mortality and only 2,337 steps/day for CV mortality analysis), which somewhat lowers the bar for finding a significant benefit at higher step counts.
“Moreover, in the spline analyses, zero steps per day is used as the comparison, which is not a practical, real-world comparison,” he said. “As a result, those data are very hard to interpret, and I think are overstated.”
Like Dr. Banach, Dr. Brittain said he would continue to advise following guideline recommendations to get 150 minutes per week of moderate-intensity activity. However, he added that although it is reasonable to advise patients that benefits do accrue with daily step counts of less than 10,000, “I would not want patients to misconstrue from this study that getting more than only 2,330 steps per day is a beneficial goal.”
Martin Halle, MD, a professor in the department of prevention and sports medicine at the Technical University of Munich (Germany), said: “From a clinical, medical, and health perspective, the general population should aim for 5,000 steps, which is about 3-4 kilometers [about 2 miles] of walking, and intensity counts – the faster you walk, the better.
“I recommend doing 100 steps fast and 100 steps slow and then 100 steps fast and 100 steps slow,” said Dr. Halle, who is past president of the European Association of Preventive Cardiology. This approach not only motivates people, “but they improve their exercise capacity substantially and very quickly, just within weeks.”
European Society of Cardiology vice president and European Journal of Preventive Cardiology editor-in-chief Massimo Piepoli, MD, PhD, agreed that “little is better than nothing and more is even better. This applies to healthy subjects, as well as patients with chronic diseases.
“Five hundred steps is a very short distance (such as walking two blocks or walking the dog for about 10-15 minutes every day),” he said. Yet, increasing step counts in increments of 500 “is associated with a significant reduction in cardiovascular mortality both in men and women, particularly in older individuals.
“We do not need to depend on expensive gym facilities,” he added. “But at the same time, we need to live in and to promote the building of neighborhoods where it is possible to walk in a safe and healthy environment.”
The research received no external funding. Dr. Banach has reported financial relationships with Amgen, Daiichi Sankyo, Esperion, Freia Pharmaceuticals, Kogen, KRKA, Polpharma, NewAmsterdam, Novartis, Novo Nordisk, Polfarmex, Sanofi Aventis, Teva, Valeant, Viatris, and Zentiva, and is chief marketing and development officer at Longevity Group and chief marketing officer at Nomi Biotech.
A version of this article first appeared on Medscape.com.
in a new meta-analysis.
More steps were better – additional benefit was seen with increasing increments of 500 or 1,000 steps.
“One of our main aims was to overcome all the inconsistencies in previous studies, where the optimal number of daily steps for health benefits was usually between 6,000 and 10,000,” Maciej Banach, MD, PhD, of the Medical University of Lodz (Poland), said in an interview.
“As a preventive cardiologist, I saw that many of my patients were discouraged and said it’s impossible when I told them that making lifestyle changes included taking at least 7,000 daily steps,” he said.
“But our study in relatively healthy individuals, not patients, showed even a lower number – for example, around 4,000 – may be associated with a significant reduction of mortality.
“I tell people to start early, be regular, and don’t worry about the initial baseline number, because it’s important to start and it’s important to improve,” he said. “Our study showed that if we increase the number of steps per day, every 500- to 1,000-step increase might still be associated with an additional mortality reduction of 7%-15%.”
The study was published online in the European Journal of Preventive Cardiology.
Every move counts
The investigators searched the literature through June 2022 and selected 17 cohort studies with 226,889 participants and a median follow-up of 7.1 years for inclusion in the analysis: 10 studies reported all-cause mortality, 4 reported CV mortality, and 3 reported both outcomes.
The mean age of the participants was 64.4 years, and half were women. Daily step counts in the included studies were objectively measured for at least 7 consecutive days.
As noted, a 1,000-step increment was associated with a 15% decrease in risk of all-cause mortality (hazard ratio, 0.85); a 500-step increment was associated with a 7% decrease in CV mortality (HR, 0.93).
Compared with the reference quartile (median steps/day, 3,967), quartile 1 (median steps, 5,537) was associated with a 48% lower risk of all-cause mortality; quartile 2 (median steps, 7,370), with a 55% lower risk; and quartile 3 (median steps, 11,529), with a 67% risk reduction.
Similarly, compared with the lowest quartile of steps per day used as reference (median steps, 2,337), higher quartiles of steps per day (Q1, 3,982; Q2, 6,661; and Q3, 10,413) were linearly associated with a reduced risk of CV mortality (16%, 49%, and 77%, respectively).
In a restricted cubic splines model, a nonlinear dose-response association was observed between step count and all-cause and CV mortality, with a progressively lower risk of mortality with an increase in step count.
Dose-response curves were similar for men and women. However, there was a difference by age: Among people aged 60 years or older, the size of the risk reduction was smaller. Among the older adults, there was a 42% risk reduction for those who walked between 6000 and 10,000 steps daily, compared with a 49% reduction in risk among younger adults who walked between 7,000 and 13,000 steps a day.
For both groups, daily step counts higher than 5,000 resulted in a “dramatically” lower risk of all-cause mortality.
An analysis that compared the impact of climate regions on the associations showed no significant effect on all-cause mortality. People in all climate zones benefited when the daily step count exceeded approximately 5,500.
Even given the encouraging study results, “we know very well that every kind of exercise is critically important,” Dr. Banach said. It is easier to focus on step counts because the counts can be monitored and calculated with smartwatches, pedometers, and other tools. That also makes it easier to check associations and outcomes for large groups of patients.
“But in fact, we should not be focusing on one type of exercise, such as walking or running,” he said. “We can dance, ride bicycles, and do many other different exercises that mobilize our hearts.
“We also know that in all these activities, including steps, people have different capabilities – for example, some can walk more slowly, others faster and with more intensity.”
Dr. Banach recommended following the European and U.S. physical activity guidelines that advise, in addition to muscle-strengthening activities, 150 minutes of moderate-intensity aerobic training weekly, or 75 minutes of vigorous-intensity aerobic activity, or an equivalent combination of moderate- and vigorous-intensity aerobic activity.
From the results he sees in patients, he believes the combination approach is probably best for the heart.
Furthermore, it’s important to exercise regularly, something that’s easier if individuals enjoy what they’re doing. “The type of training or whether you are completely inactive or very active at the start doesn’t matter, because any improvement, any addition to the to the baseline values will have health benefits,” he concluded.
Higher goals helpful
Three experts commented on the study; all noted that the results are in line with previous studies, that the observational nature of the study is a limitation, and that additional randomized, controlled trials are needed to confirm the findings.
Evan Brittain, MD, an associate professor of medicine at Vanderbilt University Medical Center, Nashville, Tenn., expressed some additional concerns.
Dr. Brittain was principal investigator of a recent study that found that the relationship between steps per day and incident disease was inverse and linear for obesity, sleep apnea, gastroesophageal reflux disease, and major depressive disorder. Daily step counts above 8,200 were associated with protection from incident disease.
He noted that, in the current study, “the authors chose to make the least active quartile (25%) the reference group (only 3,967 steps/day for all-cause mortality and only 2,337 steps/day for CV mortality analysis), which somewhat lowers the bar for finding a significant benefit at higher step counts.
“Moreover, in the spline analyses, zero steps per day is used as the comparison, which is not a practical, real-world comparison,” he said. “As a result, those data are very hard to interpret, and I think are overstated.”
Like Dr. Banach, Dr. Brittain said he would continue to advise following guideline recommendations to get 150 minutes per week of moderate-intensity activity. However, he added that although it is reasonable to advise patients that benefits do accrue with daily step counts of less than 10,000, “I would not want patients to misconstrue from this study that getting more than only 2,330 steps per day is a beneficial goal.”
Martin Halle, MD, a professor in the department of prevention and sports medicine at the Technical University of Munich (Germany), said: “From a clinical, medical, and health perspective, the general population should aim for 5,000 steps, which is about 3-4 kilometers [about 2 miles] of walking, and intensity counts – the faster you walk, the better.
“I recommend doing 100 steps fast and 100 steps slow and then 100 steps fast and 100 steps slow,” said Dr. Halle, who is past president of the European Association of Preventive Cardiology. This approach not only motivates people, “but they improve their exercise capacity substantially and very quickly, just within weeks.”
European Society of Cardiology vice president and European Journal of Preventive Cardiology editor-in-chief Massimo Piepoli, MD, PhD, agreed that “little is better than nothing and more is even better. This applies to healthy subjects, as well as patients with chronic diseases.
“Five hundred steps is a very short distance (such as walking two blocks or walking the dog for about 10-15 minutes every day),” he said. Yet, increasing step counts in increments of 500 “is associated with a significant reduction in cardiovascular mortality both in men and women, particularly in older individuals.
“We do not need to depend on expensive gym facilities,” he added. “But at the same time, we need to live in and to promote the building of neighborhoods where it is possible to walk in a safe and healthy environment.”
The research received no external funding. Dr. Banach has reported financial relationships with Amgen, Daiichi Sankyo, Esperion, Freia Pharmaceuticals, Kogen, KRKA, Polpharma, NewAmsterdam, Novartis, Novo Nordisk, Polfarmex, Sanofi Aventis, Teva, Valeant, Viatris, and Zentiva, and is chief marketing and development officer at Longevity Group and chief marketing officer at Nomi Biotech.
A version of this article first appeared on Medscape.com.
FROM THE EUROPEAN JOURNAL OF PREVENTIVE CARDIOLOGY
Isometric exercise found optimal for lowering blood pressure?
The findings support the development of new exercise guidelines for blood pressure control, the authors said.
Previous research, based on older data that excluded high-intensity interval training (HIIT) and isometric exercise training (IET), led to aerobic exercise training (AET) being recommended for managing blood pressure, according to the authors.
Although AET, HIIT, dynamic resistance training (RT), and combined training (CT) are also effective in reducing both systolic and diastolic blood pressure, the new analysis suggests that IET does it best.
The analysis showed reductions in blood pressure of 8.24/4 mm Hg after IET, compared with 4.49/2.53 mm Hg after AET; 4.55/3.04 mm Hg after RT; 6.04/2.54 mm Hg after CT; and 4.08/2.50 mm Hg after HIIT.
“These findings mirror our smaller-scale trials, and therefore we anticipated that isometrics would be largely effective,” Jamie O’Driscoll, PhD, of Canterbury (England) Christ Church University, said in an interview. However, “the magnitude of difference between isometrics and some other modes was surprising.”
The study was published online in the British Journal of Sports Medicine.
All modes effective
The investigators analyzed data from 270 randomized controlled trials including 15,827 people published between 1990 and February 2023. For consistency, the protocol/intensity of each included paper was screened against the Exercise Prescription in Everyday Practice and Rehabilitative Training tool to be defined and categorized.
All protocols were then stratified as AET, RT, CT, HIIT or IET.
As appropriate, protocols were then further stratified into subgroups: AET included walking, running, and cycling; HIIT included sprint interval training and aerobic interval training; and IET included isometric leg extension and isometric wall squat.
Healthy resting blood pressure was defined as a reading below 130/85 mm Hg, prehypertension as 130-139/85-89 mm Hg, and hypertension as 140/90 mm Hg or higher.
All exercise modes led to statistically significant reductions in systolic BP in normal blood pressure cohorts; however, all reductions were substantially larger in individuals with hypertension.
Pairwise analyses showed significant reductions in resting systolic BP and diastolic BP following AET (−4.49/–2.53 mm Hg); RT (–4.55/–3.04 mm Hg), CT (–6.04/–2.54 mm Hg), HIT (–4.08/–2.50 mm Hg); and IET (–8.24/–4.00 mm Hg).
In the network meta-analysis, the rank order of effectiveness for systolic BP based on surface under the cumulative ranking curve values were IET (SUCRA: 98.3%), CT (75.7%), RT (46.1%), AET (40.5%), and HIIT (39.4%).
Secondary network meta-analyses showed that isometric wall squat was the most effective submode for reducing systolic BP (90.4%), followed by isometric leg extension, isometric hand grip, cycling, running, CT, sprint interval training, other aerobic, RT, aerobic interval training, and walking.
Running was the most effective submode for lowering diastolic BP (91.3%), followed by isometric wall squat, isometric handgrip, isometric leg extension, cycling, sprint interval training, RT, AIT, other aerobic, CT, and walking.
The authors acknowledged limitations, including variability in exercise interventions, missing data, variable quality of exercise monitoring and analyses, lack of blinding to group allocation, varying participant populations, and publication bias.
Nevertheless, they concluded, “the results of this analysis should inform future exercise guideline recommendations for the prevention and treatment of arterial hypertension.”
Guideline changing?
“There are numerous organizations involved in providing and communicating population exercise guidelines,” including World Health Organization, American and European exercise guidelines, and the National Institute for Health and Care Excellence, Dr. O’Driscoll said. “We are currently developing an international collaborative project with other world leaders in the area to develop this line of enquiry.”
In addition, the team is exploring the prescription of IET within England’s National Health Service and extending the study to wider clinical populations.
In a comment, John A. Osborne, MD, PhD, founder and director of State of the Heart Cardiology in Southlake, Tex., said: “This study further lends credence that other forms of exercise, beyond the usually recommended aerobic exercise promulgated in prior guidelines, have significant value for blood pressure lowering, and, potentially, may offer even greater benefits for ... controlling hypertension.”
“This study should inform contemporary nonpharmacological approaches to blood pressure management and allows providers more flexibility in different strategies of exercise to combat high blood pressure,” said Dr. Osborne, a volunteer spokesperson for the American Heart Association.
That said, “while this study by itself is extremely provocative, thoughtful, and rigorously performed, it should be used as hypothesis generating and hopefully [will be followed by] head-to-head studies of aerobic exercise versus resistance training to confirm the findings.”
The study received no funding. Dr. O’Driscoll and Dr. Osborne reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The findings support the development of new exercise guidelines for blood pressure control, the authors said.
Previous research, based on older data that excluded high-intensity interval training (HIIT) and isometric exercise training (IET), led to aerobic exercise training (AET) being recommended for managing blood pressure, according to the authors.
Although AET, HIIT, dynamic resistance training (RT), and combined training (CT) are also effective in reducing both systolic and diastolic blood pressure, the new analysis suggests that IET does it best.
The analysis showed reductions in blood pressure of 8.24/4 mm Hg after IET, compared with 4.49/2.53 mm Hg after AET; 4.55/3.04 mm Hg after RT; 6.04/2.54 mm Hg after CT; and 4.08/2.50 mm Hg after HIIT.
“These findings mirror our smaller-scale trials, and therefore we anticipated that isometrics would be largely effective,” Jamie O’Driscoll, PhD, of Canterbury (England) Christ Church University, said in an interview. However, “the magnitude of difference between isometrics and some other modes was surprising.”
The study was published online in the British Journal of Sports Medicine.
All modes effective
The investigators analyzed data from 270 randomized controlled trials including 15,827 people published between 1990 and February 2023. For consistency, the protocol/intensity of each included paper was screened against the Exercise Prescription in Everyday Practice and Rehabilitative Training tool to be defined and categorized.
All protocols were then stratified as AET, RT, CT, HIIT or IET.
As appropriate, protocols were then further stratified into subgroups: AET included walking, running, and cycling; HIIT included sprint interval training and aerobic interval training; and IET included isometric leg extension and isometric wall squat.
Healthy resting blood pressure was defined as a reading below 130/85 mm Hg, prehypertension as 130-139/85-89 mm Hg, and hypertension as 140/90 mm Hg or higher.
All exercise modes led to statistically significant reductions in systolic BP in normal blood pressure cohorts; however, all reductions were substantially larger in individuals with hypertension.
Pairwise analyses showed significant reductions in resting systolic BP and diastolic BP following AET (−4.49/–2.53 mm Hg); RT (–4.55/–3.04 mm Hg), CT (–6.04/–2.54 mm Hg), HIT (–4.08/–2.50 mm Hg); and IET (–8.24/–4.00 mm Hg).
In the network meta-analysis, the rank order of effectiveness for systolic BP based on surface under the cumulative ranking curve values were IET (SUCRA: 98.3%), CT (75.7%), RT (46.1%), AET (40.5%), and HIIT (39.4%).
Secondary network meta-analyses showed that isometric wall squat was the most effective submode for reducing systolic BP (90.4%), followed by isometric leg extension, isometric hand grip, cycling, running, CT, sprint interval training, other aerobic, RT, aerobic interval training, and walking.
Running was the most effective submode for lowering diastolic BP (91.3%), followed by isometric wall squat, isometric handgrip, isometric leg extension, cycling, sprint interval training, RT, AIT, other aerobic, CT, and walking.
The authors acknowledged limitations, including variability in exercise interventions, missing data, variable quality of exercise monitoring and analyses, lack of blinding to group allocation, varying participant populations, and publication bias.
Nevertheless, they concluded, “the results of this analysis should inform future exercise guideline recommendations for the prevention and treatment of arterial hypertension.”
Guideline changing?
“There are numerous organizations involved in providing and communicating population exercise guidelines,” including World Health Organization, American and European exercise guidelines, and the National Institute for Health and Care Excellence, Dr. O’Driscoll said. “We are currently developing an international collaborative project with other world leaders in the area to develop this line of enquiry.”
In addition, the team is exploring the prescription of IET within England’s National Health Service and extending the study to wider clinical populations.
In a comment, John A. Osborne, MD, PhD, founder and director of State of the Heart Cardiology in Southlake, Tex., said: “This study further lends credence that other forms of exercise, beyond the usually recommended aerobic exercise promulgated in prior guidelines, have significant value for blood pressure lowering, and, potentially, may offer even greater benefits for ... controlling hypertension.”
“This study should inform contemporary nonpharmacological approaches to blood pressure management and allows providers more flexibility in different strategies of exercise to combat high blood pressure,” said Dr. Osborne, a volunteer spokesperson for the American Heart Association.
That said, “while this study by itself is extremely provocative, thoughtful, and rigorously performed, it should be used as hypothesis generating and hopefully [will be followed by] head-to-head studies of aerobic exercise versus resistance training to confirm the findings.”
The study received no funding. Dr. O’Driscoll and Dr. Osborne reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The findings support the development of new exercise guidelines for blood pressure control, the authors said.
Previous research, based on older data that excluded high-intensity interval training (HIIT) and isometric exercise training (IET), led to aerobic exercise training (AET) being recommended for managing blood pressure, according to the authors.
Although AET, HIIT, dynamic resistance training (RT), and combined training (CT) are also effective in reducing both systolic and diastolic blood pressure, the new analysis suggests that IET does it best.
The analysis showed reductions in blood pressure of 8.24/4 mm Hg after IET, compared with 4.49/2.53 mm Hg after AET; 4.55/3.04 mm Hg after RT; 6.04/2.54 mm Hg after CT; and 4.08/2.50 mm Hg after HIIT.
“These findings mirror our smaller-scale trials, and therefore we anticipated that isometrics would be largely effective,” Jamie O’Driscoll, PhD, of Canterbury (England) Christ Church University, said in an interview. However, “the magnitude of difference between isometrics and some other modes was surprising.”
The study was published online in the British Journal of Sports Medicine.
All modes effective
The investigators analyzed data from 270 randomized controlled trials including 15,827 people published between 1990 and February 2023. For consistency, the protocol/intensity of each included paper was screened against the Exercise Prescription in Everyday Practice and Rehabilitative Training tool to be defined and categorized.
All protocols were then stratified as AET, RT, CT, HIIT or IET.
As appropriate, protocols were then further stratified into subgroups: AET included walking, running, and cycling; HIIT included sprint interval training and aerobic interval training; and IET included isometric leg extension and isometric wall squat.
Healthy resting blood pressure was defined as a reading below 130/85 mm Hg, prehypertension as 130-139/85-89 mm Hg, and hypertension as 140/90 mm Hg or higher.
All exercise modes led to statistically significant reductions in systolic BP in normal blood pressure cohorts; however, all reductions were substantially larger in individuals with hypertension.
Pairwise analyses showed significant reductions in resting systolic BP and diastolic BP following AET (−4.49/–2.53 mm Hg); RT (–4.55/–3.04 mm Hg), CT (–6.04/–2.54 mm Hg), HIT (–4.08/–2.50 mm Hg); and IET (–8.24/–4.00 mm Hg).
In the network meta-analysis, the rank order of effectiveness for systolic BP based on surface under the cumulative ranking curve values were IET (SUCRA: 98.3%), CT (75.7%), RT (46.1%), AET (40.5%), and HIIT (39.4%).
Secondary network meta-analyses showed that isometric wall squat was the most effective submode for reducing systolic BP (90.4%), followed by isometric leg extension, isometric hand grip, cycling, running, CT, sprint interval training, other aerobic, RT, aerobic interval training, and walking.
Running was the most effective submode for lowering diastolic BP (91.3%), followed by isometric wall squat, isometric handgrip, isometric leg extension, cycling, sprint interval training, RT, AIT, other aerobic, CT, and walking.
The authors acknowledged limitations, including variability in exercise interventions, missing data, variable quality of exercise monitoring and analyses, lack of blinding to group allocation, varying participant populations, and publication bias.
Nevertheless, they concluded, “the results of this analysis should inform future exercise guideline recommendations for the prevention and treatment of arterial hypertension.”
Guideline changing?
“There are numerous organizations involved in providing and communicating population exercise guidelines,” including World Health Organization, American and European exercise guidelines, and the National Institute for Health and Care Excellence, Dr. O’Driscoll said. “We are currently developing an international collaborative project with other world leaders in the area to develop this line of enquiry.”
In addition, the team is exploring the prescription of IET within England’s National Health Service and extending the study to wider clinical populations.
In a comment, John A. Osborne, MD, PhD, founder and director of State of the Heart Cardiology in Southlake, Tex., said: “This study further lends credence that other forms of exercise, beyond the usually recommended aerobic exercise promulgated in prior guidelines, have significant value for blood pressure lowering, and, potentially, may offer even greater benefits for ... controlling hypertension.”
“This study should inform contemporary nonpharmacological approaches to blood pressure management and allows providers more flexibility in different strategies of exercise to combat high blood pressure,” said Dr. Osborne, a volunteer spokesperson for the American Heart Association.
That said, “while this study by itself is extremely provocative, thoughtful, and rigorously performed, it should be used as hypothesis generating and hopefully [will be followed by] head-to-head studies of aerobic exercise versus resistance training to confirm the findings.”
The study received no funding. Dr. O’Driscoll and Dr. Osborne reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE BRITISH JOURNAL OF SPORTS MEDICINE
Serious arrhythmias playing video games ‘extremely rare’
provided their condition is properly treated, say researchers based on their large, single-center study.
Among more than 3,000 patients in the study with such a genetic vulnerability, just 6 – or less than 0.2% – experienced an electronic gaming–associated cardiac event.
A previous study had concluded that e-gaming, particularly with war games, might trigger potentially fatal arrhythmias in some vulnerable children. That study “sparked controversy in the field, with both clinicians and patients wondering whether electronic gaming is safe for patients with GHDs,” Michael J. Ackerman, MD, PhD, of Mayo Clinic in Rochester, Minn., said in an interview.
Dr. Ackerman and colleagues conducted the current study, published online in the Journal of the American College of Cardiology, to determine just how often e-gaming triggered cardiac events (CE) in these patients – and who was most at risk.
‘Extremely low’ risk
The investigators looked at records from all patients evaluated and treated at the Mayo Clinic’s genetic heart rhythm clinic from 2000 to 2022. They identified those with a history of playing electronic games at the time of their CE, defined here as such an event occurring before diagnosis, or breakthrough cardiac event (BCE), meaning an event occurring after diagnosis.
A total of 3,370 patients with a GHD (55% female) were included in the analysis. More than half (52%) were diagnosed with long-QT syndrome (LQTS). The remainder had various GHDs including, among others, catecholaminergic polymorphic ventricular tachycardia (CPVT) or hypertrophic cardiomyopathy (HCM).
The mean age at first evaluation was 27; 14% of the participants were age 6 or younger, 33% were age 7-20, and 53% were 21 or older. Most patients in each of the three age groups were diagnosed with either LQTS or CPVT.
Of the 3,370 GHD patients, 1,079 (32%) had a CE before diagnosis.
Six patients (0.5%) had a CE in the setting of e-gaming, including five for whom it was the sentinel CE. Five also had CEs in settings not involving e-gaming. Their average age at the time of the CE was 13.
Three of the six patients were diagnosed with CPVT (including two CPVT1 and one CPVT2). Of the others, one was diagnosed with LQT1, one with ventricular fibrillation triggered by premature ventricular contractions, and one with catecholamine-sensitive right ventricular outflow tract ventricular tachycardia (RVOT-VT).
After appropriate treatment, none of the six experienced a BCE during follow-ups ranging from 7 months to 4 years.
Among the full cohort of 3370 patients with GHD, 431 (13%) experienced one or more BCE during follow-up. Of those, one with catecholamine-sensitive RVOT-VT experienced an e-gaming–associated BCE.
“Although anecdotal e-gaming–associated cardiac events, including [sudden cardiac death], have been reported, the absolute risk is extremely low,” the authors wrote.
“Although there are no clear health benefits associated with e-gaming,” Dr. Ackerman said, “the risk of sudden death should not be used as an argument in an effort to curtail the amount of time patients spend e-gaming.”
Furthermore, he added, e-gaming is important to some patients’ quality of life. If patients are “properly diagnosed, risk stratified, and treated, it is okay to engage in e-gaming.”
However, “given that e-gaming may pose some risks, especially when compounded with additional factors such as dehydration, sleep deprivation, and use of performance-enhancing substances such as energy drinks, patients need to be counseled on the potential adverse health consequences,” Dr. Ackerman said.
“To this end,” he added, “we are proponents of incorporating e-gaming status into the clinical evaluation and electronic health record.”
“We would continue to urge common sense and individual risk assessment, with shared decision-making, for those where this may be an issue,” Claire M. Lawley, MBBS, PhD, Children’s Hospital at Westmead (Australia), said in an interview.
“Additionally, syncope during electronic gaming should prompt medical review,” said Dr. Lawley, lead author of the study that prompted Ackerman and colleagues to investigate the issue further.
Buddy system
Maully J. Shah, MBBS, led a study published in 2020 focusing on two case reports of syncope and potentially life-threatening ventricular arrhythmias provoked by emotional surges during play with violent video games.
Nevertheless, “we do not restrict patients from participating in e-games,” Dr. Shah, a pediatric cardiac electrophysiologist at the Cardiac Center at Children’s Hospital of Philadelphia, said in an interview. “We inform them about the available data regarding the very rare but possible occurrence of an event from e-gaming so that they can make an informed decision.”
Dr. Shah agreed that, “even in children not known to have a cardiac condition, syncope associated with emotional responses during violent video games should prompt cardiac evaluation, similar to exercise-induced syncope.”
If a patient wishes to play e-games, clinicians should ensure medication compliance and recommend a “buddy” system. “Don’t be alone while playing,” she said.
“The present study and previous reports make one pause to think whether these CEs and catecholaminergic drives can occur with sports only. If we now consider electronic gaming as a potential risk, what other activities need to be included?” wrote the authors of an accompanying editorial, led by Shankar Baskar, MD, Cincinnati Children’s Medical Center.
“A catecholaminergic drive can occur in many settings with activities of daily living or activities not considered to be competitive,” the editorialists wrote. “Ultimately these events [are] rare, but they can have life-threatening consequences, and at the same time they might not be altogether preventable and, as in electronic gaming, might be an activity that improves quality of life, especially in those who might be restricted from other sports.”
Dr. Ackerman disclosed consulting for Abbott, Boston Scientific, Bristol-Myers Squibb, Daiichi Sankyo, Invitae, Medtronic, Tenaya Therapeutics, and UpToDate. Dr. Ackerman and the Mayo Clinic have license agreements with AliveCor, Anumana, ARMGO Pharma, Pfizer, and Thryv Therapeutics. The other coauthors reported no relevant relationships. Dr. Baskar and colleagues reported no relevant relationships. Dr. Shah disclosed she is a consultant to Medtronic.
A version of this article first appeared on Medscape.com.
provided their condition is properly treated, say researchers based on their large, single-center study.
Among more than 3,000 patients in the study with such a genetic vulnerability, just 6 – or less than 0.2% – experienced an electronic gaming–associated cardiac event.
A previous study had concluded that e-gaming, particularly with war games, might trigger potentially fatal arrhythmias in some vulnerable children. That study “sparked controversy in the field, with both clinicians and patients wondering whether electronic gaming is safe for patients with GHDs,” Michael J. Ackerman, MD, PhD, of Mayo Clinic in Rochester, Minn., said in an interview.
Dr. Ackerman and colleagues conducted the current study, published online in the Journal of the American College of Cardiology, to determine just how often e-gaming triggered cardiac events (CE) in these patients – and who was most at risk.
‘Extremely low’ risk
The investigators looked at records from all patients evaluated and treated at the Mayo Clinic’s genetic heart rhythm clinic from 2000 to 2022. They identified those with a history of playing electronic games at the time of their CE, defined here as such an event occurring before diagnosis, or breakthrough cardiac event (BCE), meaning an event occurring after diagnosis.
A total of 3,370 patients with a GHD (55% female) were included in the analysis. More than half (52%) were diagnosed with long-QT syndrome (LQTS). The remainder had various GHDs including, among others, catecholaminergic polymorphic ventricular tachycardia (CPVT) or hypertrophic cardiomyopathy (HCM).
The mean age at first evaluation was 27; 14% of the participants were age 6 or younger, 33% were age 7-20, and 53% were 21 or older. Most patients in each of the three age groups were diagnosed with either LQTS or CPVT.
Of the 3,370 GHD patients, 1,079 (32%) had a CE before diagnosis.
Six patients (0.5%) had a CE in the setting of e-gaming, including five for whom it was the sentinel CE. Five also had CEs in settings not involving e-gaming. Their average age at the time of the CE was 13.
Three of the six patients were diagnosed with CPVT (including two CPVT1 and one CPVT2). Of the others, one was diagnosed with LQT1, one with ventricular fibrillation triggered by premature ventricular contractions, and one with catecholamine-sensitive right ventricular outflow tract ventricular tachycardia (RVOT-VT).
After appropriate treatment, none of the six experienced a BCE during follow-ups ranging from 7 months to 4 years.
Among the full cohort of 3370 patients with GHD, 431 (13%) experienced one or more BCE during follow-up. Of those, one with catecholamine-sensitive RVOT-VT experienced an e-gaming–associated BCE.
“Although anecdotal e-gaming–associated cardiac events, including [sudden cardiac death], have been reported, the absolute risk is extremely low,” the authors wrote.
“Although there are no clear health benefits associated with e-gaming,” Dr. Ackerman said, “the risk of sudden death should not be used as an argument in an effort to curtail the amount of time patients spend e-gaming.”
Furthermore, he added, e-gaming is important to some patients’ quality of life. If patients are “properly diagnosed, risk stratified, and treated, it is okay to engage in e-gaming.”
However, “given that e-gaming may pose some risks, especially when compounded with additional factors such as dehydration, sleep deprivation, and use of performance-enhancing substances such as energy drinks, patients need to be counseled on the potential adverse health consequences,” Dr. Ackerman said.
“To this end,” he added, “we are proponents of incorporating e-gaming status into the clinical evaluation and electronic health record.”
“We would continue to urge common sense and individual risk assessment, with shared decision-making, for those where this may be an issue,” Claire M. Lawley, MBBS, PhD, Children’s Hospital at Westmead (Australia), said in an interview.
“Additionally, syncope during electronic gaming should prompt medical review,” said Dr. Lawley, lead author of the study that prompted Ackerman and colleagues to investigate the issue further.
Buddy system
Maully J. Shah, MBBS, led a study published in 2020 focusing on two case reports of syncope and potentially life-threatening ventricular arrhythmias provoked by emotional surges during play with violent video games.
Nevertheless, “we do not restrict patients from participating in e-games,” Dr. Shah, a pediatric cardiac electrophysiologist at the Cardiac Center at Children’s Hospital of Philadelphia, said in an interview. “We inform them about the available data regarding the very rare but possible occurrence of an event from e-gaming so that they can make an informed decision.”
Dr. Shah agreed that, “even in children not known to have a cardiac condition, syncope associated with emotional responses during violent video games should prompt cardiac evaluation, similar to exercise-induced syncope.”
If a patient wishes to play e-games, clinicians should ensure medication compliance and recommend a “buddy” system. “Don’t be alone while playing,” she said.
“The present study and previous reports make one pause to think whether these CEs and catecholaminergic drives can occur with sports only. If we now consider electronic gaming as a potential risk, what other activities need to be included?” wrote the authors of an accompanying editorial, led by Shankar Baskar, MD, Cincinnati Children’s Medical Center.
“A catecholaminergic drive can occur in many settings with activities of daily living or activities not considered to be competitive,” the editorialists wrote. “Ultimately these events [are] rare, but they can have life-threatening consequences, and at the same time they might not be altogether preventable and, as in electronic gaming, might be an activity that improves quality of life, especially in those who might be restricted from other sports.”
Dr. Ackerman disclosed consulting for Abbott, Boston Scientific, Bristol-Myers Squibb, Daiichi Sankyo, Invitae, Medtronic, Tenaya Therapeutics, and UpToDate. Dr. Ackerman and the Mayo Clinic have license agreements with AliveCor, Anumana, ARMGO Pharma, Pfizer, and Thryv Therapeutics. The other coauthors reported no relevant relationships. Dr. Baskar and colleagues reported no relevant relationships. Dr. Shah disclosed she is a consultant to Medtronic.
A version of this article first appeared on Medscape.com.
provided their condition is properly treated, say researchers based on their large, single-center study.
Among more than 3,000 patients in the study with such a genetic vulnerability, just 6 – or less than 0.2% – experienced an electronic gaming–associated cardiac event.
A previous study had concluded that e-gaming, particularly with war games, might trigger potentially fatal arrhythmias in some vulnerable children. That study “sparked controversy in the field, with both clinicians and patients wondering whether electronic gaming is safe for patients with GHDs,” Michael J. Ackerman, MD, PhD, of Mayo Clinic in Rochester, Minn., said in an interview.
Dr. Ackerman and colleagues conducted the current study, published online in the Journal of the American College of Cardiology, to determine just how often e-gaming triggered cardiac events (CE) in these patients – and who was most at risk.
‘Extremely low’ risk
The investigators looked at records from all patients evaluated and treated at the Mayo Clinic’s genetic heart rhythm clinic from 2000 to 2022. They identified those with a history of playing electronic games at the time of their CE, defined here as such an event occurring before diagnosis, or breakthrough cardiac event (BCE), meaning an event occurring after diagnosis.
A total of 3,370 patients with a GHD (55% female) were included in the analysis. More than half (52%) were diagnosed with long-QT syndrome (LQTS). The remainder had various GHDs including, among others, catecholaminergic polymorphic ventricular tachycardia (CPVT) or hypertrophic cardiomyopathy (HCM).
The mean age at first evaluation was 27; 14% of the participants were age 6 or younger, 33% were age 7-20, and 53% were 21 or older. Most patients in each of the three age groups were diagnosed with either LQTS or CPVT.
Of the 3,370 GHD patients, 1,079 (32%) had a CE before diagnosis.
Six patients (0.5%) had a CE in the setting of e-gaming, including five for whom it was the sentinel CE. Five also had CEs in settings not involving e-gaming. Their average age at the time of the CE was 13.
Three of the six patients were diagnosed with CPVT (including two CPVT1 and one CPVT2). Of the others, one was diagnosed with LQT1, one with ventricular fibrillation triggered by premature ventricular contractions, and one with catecholamine-sensitive right ventricular outflow tract ventricular tachycardia (RVOT-VT).
After appropriate treatment, none of the six experienced a BCE during follow-ups ranging from 7 months to 4 years.
Among the full cohort of 3370 patients with GHD, 431 (13%) experienced one or more BCE during follow-up. Of those, one with catecholamine-sensitive RVOT-VT experienced an e-gaming–associated BCE.
“Although anecdotal e-gaming–associated cardiac events, including [sudden cardiac death], have been reported, the absolute risk is extremely low,” the authors wrote.
“Although there are no clear health benefits associated with e-gaming,” Dr. Ackerman said, “the risk of sudden death should not be used as an argument in an effort to curtail the amount of time patients spend e-gaming.”
Furthermore, he added, e-gaming is important to some patients’ quality of life. If patients are “properly diagnosed, risk stratified, and treated, it is okay to engage in e-gaming.”
However, “given that e-gaming may pose some risks, especially when compounded with additional factors such as dehydration, sleep deprivation, and use of performance-enhancing substances such as energy drinks, patients need to be counseled on the potential adverse health consequences,” Dr. Ackerman said.
“To this end,” he added, “we are proponents of incorporating e-gaming status into the clinical evaluation and electronic health record.”
“We would continue to urge common sense and individual risk assessment, with shared decision-making, for those where this may be an issue,” Claire M. Lawley, MBBS, PhD, Children’s Hospital at Westmead (Australia), said in an interview.
“Additionally, syncope during electronic gaming should prompt medical review,” said Dr. Lawley, lead author of the study that prompted Ackerman and colleagues to investigate the issue further.
Buddy system
Maully J. Shah, MBBS, led a study published in 2020 focusing on two case reports of syncope and potentially life-threatening ventricular arrhythmias provoked by emotional surges during play with violent video games.
Nevertheless, “we do not restrict patients from participating in e-games,” Dr. Shah, a pediatric cardiac electrophysiologist at the Cardiac Center at Children’s Hospital of Philadelphia, said in an interview. “We inform them about the available data regarding the very rare but possible occurrence of an event from e-gaming so that they can make an informed decision.”
Dr. Shah agreed that, “even in children not known to have a cardiac condition, syncope associated with emotional responses during violent video games should prompt cardiac evaluation, similar to exercise-induced syncope.”
If a patient wishes to play e-games, clinicians should ensure medication compliance and recommend a “buddy” system. “Don’t be alone while playing,” she said.
“The present study and previous reports make one pause to think whether these CEs and catecholaminergic drives can occur with sports only. If we now consider electronic gaming as a potential risk, what other activities need to be included?” wrote the authors of an accompanying editorial, led by Shankar Baskar, MD, Cincinnati Children’s Medical Center.
“A catecholaminergic drive can occur in many settings with activities of daily living or activities not considered to be competitive,” the editorialists wrote. “Ultimately these events [are] rare, but they can have life-threatening consequences, and at the same time they might not be altogether preventable and, as in electronic gaming, might be an activity that improves quality of life, especially in those who might be restricted from other sports.”
Dr. Ackerman disclosed consulting for Abbott, Boston Scientific, Bristol-Myers Squibb, Daiichi Sankyo, Invitae, Medtronic, Tenaya Therapeutics, and UpToDate. Dr. Ackerman and the Mayo Clinic have license agreements with AliveCor, Anumana, ARMGO Pharma, Pfizer, and Thryv Therapeutics. The other coauthors reported no relevant relationships. Dr. Baskar and colleagues reported no relevant relationships. Dr. Shah disclosed she is a consultant to Medtronic.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Clinicians debate the usefulness of NAFLD name change
Some clinicians say it’s “confusing” and “ridiculous” to change the name and diagnostic criteria of an established liver disease, while others bemoan the seemingly political reasons why it happened. Yet recently, 236 panelists from 56 countries decided that the terms nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) rely on “exclusionary confounder terms and the use of potentially stigmatizing language.”
In a report published in Hepatology, the panelists, members of the NAFLD Nomenclature Consensus Group, determined that steatotic liver disease (SLD) would be used as an “overarching term to encompass the various etiologies of steatosis.”
Metabolic dysfunction–associated steatotic liver disease (MASLD) was chosen to replace NAFLD, and the definition was changed to include at least one of five cardiometabolic risk factors.
Metabolic dysfunction–associated steatohepatitis (MASH) replaces NASH.
Those with no metabolic parameters and no known cause will be diagnosed with cryptogenic SLD.
A new category, MetALD, now describes those with MASLD who drink more alcohol per week – 140-350 g for men and 210-420 g for women.
The changes did not sit well with this news organization’s readers from diverse specialties, including family practice, critical care, and gastroenterology.
In its report, the consensus group wrote that 74% of respondents to its rounds of surveys felt the current nomenclature “was sufficiently flawed to consider a name change.”
The terms “nonalcoholic” and “fatty” were felt to be stigmatizing by 61% and 66% of respondents, respectively, according to the group, a multi-stakeholder effort under the auspices of the American Association for Study of Liver Disease and the European Association for Study of the Liver, in collaboration with the Asociación Latinoamericana para el Estudio del Hígado.
Consensus was defined a priori as a supermajority (67%) vote.
“The new nomenclature and diagnostic criteria are widely supported, nonstigmatizing, and can improve awareness and patient identification,” the group concluded.
“No way” sums up many of the almost 60 reader comments received on this news organization’s story covering the change. Readers must share medical credentials to publicly comment on stories.
‘Confusing’ and ‘ridiculous’
A number of readers questioned how the changes will help practice.
“Once again, the specialists and other experts are changing the nomenclature to make the subject even more confusing for us primary care practitioners,” an HIV/AIDS physician wrote. “They obviously have no idea what [primary care practitioners] have to put up with day in and day out. All such revisions do is increase the cynicism and anger so many [primary care practitioners] have.”
Similarly, an internist said, “These new terms are going to confuse both doctors and patients. When you give a patient a diagnosis like this, they will not understand it, and will not be able to act as they should to correct it.”
“ ‘Fatty liver’ is a jargon-free diagnosis, easy to understand and easy for patients to know what they need to do,” the internist continued. “You think patients are gonna be educated when you tell them they have a ‘metabolic disease’? 100% they will not know what you’re talking about.”
Yet another wondered, “If SLD is the ‘umbrella’ term, why (are) MetALD and ALD not MetASLD and ASLD, respectively? Furthermore, efforts to ‘destigmatize’ terminology will inadvertently condemn cryptogenic SLD (CSLD) as the new ‘closet alcoholic.’ “
“Perhaps a subclassification, CSLD-HDIRDD (CSLD–Honest, Doc, I Really Don’t Drink),” the reader added.
“Everything about this is ridiculous,” a family physician wrote. “How long will it be until the experts change obesity to ‘gravitationally challenged’ as a diagnosis!”
“I was thinking of ‘circumferentially challenged,’” a reader in Canada chimed in. “But that would be ‘body shaming’ would it not?”
This reader continued, asking, “What about returning to the old practice of using Latin names patients don’t understand so there is no ‘shame’ attached to them? Or what about this revolutionary idea: To just say it as it is – fat?”
Acceding to ‘wokeness’
A sizable number of readers felt the name changes were motivated by a “woke” awareness.
“The effect of this new ‘woke’ clarity is ridiculous and simply not worth it! Can we justify the cost of this? Patients will have to learn all over again how to discuss their condition,” said one reader.
The reader continued, saying, “The Internet and social media freely use the term ‘fat’ – and despite not wanting to offend – there seems to be universal agreement that FAT, in certain conditions or places, is unhealthy and undesirable.
“Why is the medical community so afraid to tell it like it is? I might hurt your feelings, but I could save your life,” concluded the reader.
Defending change
One commentator, a hepatologist in France, defended the changes and responded to some of complaints.
“Maybe people who comment here should read the article, reflect, and understand the reasons why the old nomenclature and definition were scientifically inaccurate and needed to be changed,” the commentator wrote.
“It was an exclusionary, negative definition not recognizing the root of the disease (adipose tissue dysfunction with insulin resistance – instead defining it by what it is not ...) and not allowing the recognition of a large segment of the population [that] accumulates metabolic risk factors and moderate alcohol consumption. These patients were left out of all studies. Those were the main reasons for change and not the stigma part – with the word ‘fatty’ only being an issue in English-speaking countries, not elsewhere,” the commentator continued.
“Calls for change have been voiced for 20 years and a first comprehensive attempt (called MAFLD) was introduced 3 years ago (J Hepatol. 2020;73:202-9). Please, a little bit of respect and restraint in the comments recognizing the research efforts and publications for those that contributed to the field over the past 25 years ...” the hepatologist wrote.
The reader added, “Clinicians and researchers were dissatisfied for a long time, but it took years to gather overwhelming evidence demonstrating what causes the disease and then to kickstart a process under the auspices of several multinational scientific societies and come up with something consensually agreed upon by a large number of clinician researchers.
“Now you can tell your patient that he has metabolic liver disease instead of telling him that the problem at the root of his disease is that he is not drinking alcohol (nonalcoholic steatohepatitis). So, again, it is not so much about changing a name but about redefining diagnostic criteria and a nosological framework,” the reader wrote.
Other readers responded to the defender:
“This nomenclature issue has been churned for 20+ years? Well, the mountain has labored heavily, and given birth to a mouse,” one said.
“Still, how is this going to help in the clinical management? The whole gamut of conditions are evaluated and treated as a whole, not in isolation,” a general practitioner in India said. “If someone has a risk factor or not, continuous follow-up is required as a whole, whether it’s nonalcoholic or alcoholic, or whatever term is coined up.”
Finally, a family physician said, “It just rolls off the tongue, doesn’t it? But I have to admit, it’s the one place where ‘persons’ from 56 countries can get together and agree on something. Not even politicians can do that! Me, I’m sticking with NAFLD.”
A version of this article first appeared on Medscape.com.
Some clinicians say it’s “confusing” and “ridiculous” to change the name and diagnostic criteria of an established liver disease, while others bemoan the seemingly political reasons why it happened. Yet recently, 236 panelists from 56 countries decided that the terms nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) rely on “exclusionary confounder terms and the use of potentially stigmatizing language.”
In a report published in Hepatology, the panelists, members of the NAFLD Nomenclature Consensus Group, determined that steatotic liver disease (SLD) would be used as an “overarching term to encompass the various etiologies of steatosis.”
Metabolic dysfunction–associated steatotic liver disease (MASLD) was chosen to replace NAFLD, and the definition was changed to include at least one of five cardiometabolic risk factors.
Metabolic dysfunction–associated steatohepatitis (MASH) replaces NASH.
Those with no metabolic parameters and no known cause will be diagnosed with cryptogenic SLD.
A new category, MetALD, now describes those with MASLD who drink more alcohol per week – 140-350 g for men and 210-420 g for women.
The changes did not sit well with this news organization’s readers from diverse specialties, including family practice, critical care, and gastroenterology.
In its report, the consensus group wrote that 74% of respondents to its rounds of surveys felt the current nomenclature “was sufficiently flawed to consider a name change.”
The terms “nonalcoholic” and “fatty” were felt to be stigmatizing by 61% and 66% of respondents, respectively, according to the group, a multi-stakeholder effort under the auspices of the American Association for Study of Liver Disease and the European Association for Study of the Liver, in collaboration with the Asociación Latinoamericana para el Estudio del Hígado.
Consensus was defined a priori as a supermajority (67%) vote.
“The new nomenclature and diagnostic criteria are widely supported, nonstigmatizing, and can improve awareness and patient identification,” the group concluded.
“No way” sums up many of the almost 60 reader comments received on this news organization’s story covering the change. Readers must share medical credentials to publicly comment on stories.
‘Confusing’ and ‘ridiculous’
A number of readers questioned how the changes will help practice.
“Once again, the specialists and other experts are changing the nomenclature to make the subject even more confusing for us primary care practitioners,” an HIV/AIDS physician wrote. “They obviously have no idea what [primary care practitioners] have to put up with day in and day out. All such revisions do is increase the cynicism and anger so many [primary care practitioners] have.”
Similarly, an internist said, “These new terms are going to confuse both doctors and patients. When you give a patient a diagnosis like this, they will not understand it, and will not be able to act as they should to correct it.”
“ ‘Fatty liver’ is a jargon-free diagnosis, easy to understand and easy for patients to know what they need to do,” the internist continued. “You think patients are gonna be educated when you tell them they have a ‘metabolic disease’? 100% they will not know what you’re talking about.”
Yet another wondered, “If SLD is the ‘umbrella’ term, why (are) MetALD and ALD not MetASLD and ASLD, respectively? Furthermore, efforts to ‘destigmatize’ terminology will inadvertently condemn cryptogenic SLD (CSLD) as the new ‘closet alcoholic.’ “
“Perhaps a subclassification, CSLD-HDIRDD (CSLD–Honest, Doc, I Really Don’t Drink),” the reader added.
“Everything about this is ridiculous,” a family physician wrote. “How long will it be until the experts change obesity to ‘gravitationally challenged’ as a diagnosis!”
“I was thinking of ‘circumferentially challenged,’” a reader in Canada chimed in. “But that would be ‘body shaming’ would it not?”
This reader continued, asking, “What about returning to the old practice of using Latin names patients don’t understand so there is no ‘shame’ attached to them? Or what about this revolutionary idea: To just say it as it is – fat?”
Acceding to ‘wokeness’
A sizable number of readers felt the name changes were motivated by a “woke” awareness.
“The effect of this new ‘woke’ clarity is ridiculous and simply not worth it! Can we justify the cost of this? Patients will have to learn all over again how to discuss their condition,” said one reader.
The reader continued, saying, “The Internet and social media freely use the term ‘fat’ – and despite not wanting to offend – there seems to be universal agreement that FAT, in certain conditions or places, is unhealthy and undesirable.
“Why is the medical community so afraid to tell it like it is? I might hurt your feelings, but I could save your life,” concluded the reader.
Defending change
One commentator, a hepatologist in France, defended the changes and responded to some of complaints.
“Maybe people who comment here should read the article, reflect, and understand the reasons why the old nomenclature and definition were scientifically inaccurate and needed to be changed,” the commentator wrote.
“It was an exclusionary, negative definition not recognizing the root of the disease (adipose tissue dysfunction with insulin resistance – instead defining it by what it is not ...) and not allowing the recognition of a large segment of the population [that] accumulates metabolic risk factors and moderate alcohol consumption. These patients were left out of all studies. Those were the main reasons for change and not the stigma part – with the word ‘fatty’ only being an issue in English-speaking countries, not elsewhere,” the commentator continued.
“Calls for change have been voiced for 20 years and a first comprehensive attempt (called MAFLD) was introduced 3 years ago (J Hepatol. 2020;73:202-9). Please, a little bit of respect and restraint in the comments recognizing the research efforts and publications for those that contributed to the field over the past 25 years ...” the hepatologist wrote.
The reader added, “Clinicians and researchers were dissatisfied for a long time, but it took years to gather overwhelming evidence demonstrating what causes the disease and then to kickstart a process under the auspices of several multinational scientific societies and come up with something consensually agreed upon by a large number of clinician researchers.
“Now you can tell your patient that he has metabolic liver disease instead of telling him that the problem at the root of his disease is that he is not drinking alcohol (nonalcoholic steatohepatitis). So, again, it is not so much about changing a name but about redefining diagnostic criteria and a nosological framework,” the reader wrote.
Other readers responded to the defender:
“This nomenclature issue has been churned for 20+ years? Well, the mountain has labored heavily, and given birth to a mouse,” one said.
“Still, how is this going to help in the clinical management? The whole gamut of conditions are evaluated and treated as a whole, not in isolation,” a general practitioner in India said. “If someone has a risk factor or not, continuous follow-up is required as a whole, whether it’s nonalcoholic or alcoholic, or whatever term is coined up.”
Finally, a family physician said, “It just rolls off the tongue, doesn’t it? But I have to admit, it’s the one place where ‘persons’ from 56 countries can get together and agree on something. Not even politicians can do that! Me, I’m sticking with NAFLD.”
A version of this article first appeared on Medscape.com.
Some clinicians say it’s “confusing” and “ridiculous” to change the name and diagnostic criteria of an established liver disease, while others bemoan the seemingly political reasons why it happened. Yet recently, 236 panelists from 56 countries decided that the terms nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) rely on “exclusionary confounder terms and the use of potentially stigmatizing language.”
In a report published in Hepatology, the panelists, members of the NAFLD Nomenclature Consensus Group, determined that steatotic liver disease (SLD) would be used as an “overarching term to encompass the various etiologies of steatosis.”
Metabolic dysfunction–associated steatotic liver disease (MASLD) was chosen to replace NAFLD, and the definition was changed to include at least one of five cardiometabolic risk factors.
Metabolic dysfunction–associated steatohepatitis (MASH) replaces NASH.
Those with no metabolic parameters and no known cause will be diagnosed with cryptogenic SLD.
A new category, MetALD, now describes those with MASLD who drink more alcohol per week – 140-350 g for men and 210-420 g for women.
The changes did not sit well with this news organization’s readers from diverse specialties, including family practice, critical care, and gastroenterology.
In its report, the consensus group wrote that 74% of respondents to its rounds of surveys felt the current nomenclature “was sufficiently flawed to consider a name change.”
The terms “nonalcoholic” and “fatty” were felt to be stigmatizing by 61% and 66% of respondents, respectively, according to the group, a multi-stakeholder effort under the auspices of the American Association for Study of Liver Disease and the European Association for Study of the Liver, in collaboration with the Asociación Latinoamericana para el Estudio del Hígado.
Consensus was defined a priori as a supermajority (67%) vote.
“The new nomenclature and diagnostic criteria are widely supported, nonstigmatizing, and can improve awareness and patient identification,” the group concluded.
“No way” sums up many of the almost 60 reader comments received on this news organization’s story covering the change. Readers must share medical credentials to publicly comment on stories.
‘Confusing’ and ‘ridiculous’
A number of readers questioned how the changes will help practice.
“Once again, the specialists and other experts are changing the nomenclature to make the subject even more confusing for us primary care practitioners,” an HIV/AIDS physician wrote. “They obviously have no idea what [primary care practitioners] have to put up with day in and day out. All such revisions do is increase the cynicism and anger so many [primary care practitioners] have.”
Similarly, an internist said, “These new terms are going to confuse both doctors and patients. When you give a patient a diagnosis like this, they will not understand it, and will not be able to act as they should to correct it.”
“ ‘Fatty liver’ is a jargon-free diagnosis, easy to understand and easy for patients to know what they need to do,” the internist continued. “You think patients are gonna be educated when you tell them they have a ‘metabolic disease’? 100% they will not know what you’re talking about.”
Yet another wondered, “If SLD is the ‘umbrella’ term, why (are) MetALD and ALD not MetASLD and ASLD, respectively? Furthermore, efforts to ‘destigmatize’ terminology will inadvertently condemn cryptogenic SLD (CSLD) as the new ‘closet alcoholic.’ “
“Perhaps a subclassification, CSLD-HDIRDD (CSLD–Honest, Doc, I Really Don’t Drink),” the reader added.
“Everything about this is ridiculous,” a family physician wrote. “How long will it be until the experts change obesity to ‘gravitationally challenged’ as a diagnosis!”
“I was thinking of ‘circumferentially challenged,’” a reader in Canada chimed in. “But that would be ‘body shaming’ would it not?”
This reader continued, asking, “What about returning to the old practice of using Latin names patients don’t understand so there is no ‘shame’ attached to them? Or what about this revolutionary idea: To just say it as it is – fat?”
Acceding to ‘wokeness’
A sizable number of readers felt the name changes were motivated by a “woke” awareness.
“The effect of this new ‘woke’ clarity is ridiculous and simply not worth it! Can we justify the cost of this? Patients will have to learn all over again how to discuss their condition,” said one reader.
The reader continued, saying, “The Internet and social media freely use the term ‘fat’ – and despite not wanting to offend – there seems to be universal agreement that FAT, in certain conditions or places, is unhealthy and undesirable.
“Why is the medical community so afraid to tell it like it is? I might hurt your feelings, but I could save your life,” concluded the reader.
Defending change
One commentator, a hepatologist in France, defended the changes and responded to some of complaints.
“Maybe people who comment here should read the article, reflect, and understand the reasons why the old nomenclature and definition were scientifically inaccurate and needed to be changed,” the commentator wrote.
“It was an exclusionary, negative definition not recognizing the root of the disease (adipose tissue dysfunction with insulin resistance – instead defining it by what it is not ...) and not allowing the recognition of a large segment of the population [that] accumulates metabolic risk factors and moderate alcohol consumption. These patients were left out of all studies. Those were the main reasons for change and not the stigma part – with the word ‘fatty’ only being an issue in English-speaking countries, not elsewhere,” the commentator continued.
“Calls for change have been voiced for 20 years and a first comprehensive attempt (called MAFLD) was introduced 3 years ago (J Hepatol. 2020;73:202-9). Please, a little bit of respect and restraint in the comments recognizing the research efforts and publications for those that contributed to the field over the past 25 years ...” the hepatologist wrote.
The reader added, “Clinicians and researchers were dissatisfied for a long time, but it took years to gather overwhelming evidence demonstrating what causes the disease and then to kickstart a process under the auspices of several multinational scientific societies and come up with something consensually agreed upon by a large number of clinician researchers.
“Now you can tell your patient that he has metabolic liver disease instead of telling him that the problem at the root of his disease is that he is not drinking alcohol (nonalcoholic steatohepatitis). So, again, it is not so much about changing a name but about redefining diagnostic criteria and a nosological framework,” the reader wrote.
Other readers responded to the defender:
“This nomenclature issue has been churned for 20+ years? Well, the mountain has labored heavily, and given birth to a mouse,” one said.
“Still, how is this going to help in the clinical management? The whole gamut of conditions are evaluated and treated as a whole, not in isolation,” a general practitioner in India said. “If someone has a risk factor or not, continuous follow-up is required as a whole, whether it’s nonalcoholic or alcoholic, or whatever term is coined up.”
Finally, a family physician said, “It just rolls off the tongue, doesn’t it? But I have to admit, it’s the one place where ‘persons’ from 56 countries can get together and agree on something. Not even politicians can do that! Me, I’m sticking with NAFLD.”
A version of this article first appeared on Medscape.com.
Oxycodone tied to persistent use only after vaginal delivery
“In the last decade in Ontario, oxycodone surpassed codeine as the most commonly prescribed opioid postpartum for pain control,” Jonathan Zipursky, MD, PhD, of Sunnybrook Health Sciences Centre, ICES, Toronto, and the University of Toronto, said in an interview. “This likely had to do with concerns with codeine use during breastfeeding, many of which are unsubstantiated.
“We hypothesized that use of oxycodone would be associated with an increased risk of persistent postpartum opioid use,” he said. “However, we did not find this.”
Instead, other factors, such as the quantity of opioids initially prescribed, were probably more important risks, he said.
The team also was “a bit surprised” that oxycodone was associated with an increased risk of persistent use only among those who had a vaginal delivery, Dr. Zipursky added.
“Receipt of an opioid prescription after vaginal delivery is uncommon in Ontario. People who fill prescriptions for potent opioids, such as oxycodone, after vaginal delivery may have underlying characteristics that predispose them to chronic opioid use,” he suggested. “Some of these factors we were unable to assess using our data.”
The study was published online in the Canadian Medical Association Journal.
Oxycodone okay
The investigators analyzed data from 70,607 people (median age, 32) who filled an opioid prescription within 7 days of discharge from the hospital between 2012 and 2020. Two-thirds (69.8%) received oxycodone and one-third received (30.2%) codeine.
The median gestational age at delivery was 39 weeks, and 80% of participants had a cesarean delivery. The median opioid prescription duration was 3 days. The median opioid content per prescription was 150 morphine milligram equivalents (MMEs) among those prescribed oxycodone and 135 MMEs for codeine.
The main outcome was persistent opioid use. This was defined as one or more additional prescriptions for an opioid within 90 days of the first postpartum prescription and one or more additional prescriptions in the 91-365 days after.
Oxycodone receipt was not associated with persistent opioid use, compared with codeine (relative risk, 1.04).
However, in a secondary analysis by mode of delivery, an association was seen between a prescription for oxycodone and persistent use after vaginal (RR, 1.63), but not after cesarean (RR, 0.85), delivery.
Dr. Zipursky noted that the quantity of opioids prescribed in the initial postpartum prescription “is likely a more important modifiable risk factor for new persistent opioid use, rather than the type of opioid prescribed.”
For example, a prescription containing more than 225 MMEs (equivalent to about 30 tablets of 5 mg oxycodone and to 50 tablets of 30 mg codeine) was associated with a roughly twofold increased risk of persistent use, compared with less than 112.5 MMEs after both vaginal (odds ratio, 2.51) and cesarean (OR, 1.78) delivery.
Furthermore, a prescription duration of more than 7 days was also associated with a roughly twofold increased risk of persistent use, compared with a duration of 1-3 days after both vaginal (OR, 2.43) and cesarean (OR, 1.52) delivery.
Most risk factors for persistent opioid use – a history of mental illness, substance use disorder, and more maternal comorbidities (aggregated diagnosis groups > 10) – were consistent across modes of delivery.
“Awareness of modifiable factors associated with new, persistent opioid use may help clinicians tailor opioid prescribing while ensuring adequate analgesia after delivery,” Dr. Zipursky suggested.
Less is more
In a comment, Elaine Duryea, MD, assistant professor in the department of obstetrics and gynecology at UT Southwestern Medical Center and medical director of the Maternal-Fetal Medicine Clinic at Parkland Health and Hospital System, both in Dallas, said, “It is likely exposure to any opioid, rather than a specific opioid, that can promote continued use – that is, past the medically indicated period.”
Dr. Duryea was principal investigator of a study, published in the American Journal of Obstetrics and Gynecology, that showed a multimodal regimen that included scheduled nonsteroidal anti-inflammatory drugs and acetaminophen, with opioids used as needed, resulted in a decrease in opioid use while adequately controlling pain after cesarean delivery.
“It is important to understand how to appropriately tailor the amount of opioid given to patients at the time of hospital discharge after cesarean in order to treat pain effectively but not send patients home with more opioids than [are] really needed,” she said.
It is also important to “individualize prescribing practices and maximize the use of non-opioid medication to treat postpartum and postoperative pain. Opioids should be a last resort for breakthrough pain, not first-line therapy,” Dr. Duryea concluded.
The study was funded by a Canadian Institutes of Health Research project grant. Dr. Zipursky has received payments from private law firms for medicolegal opinions on the safety and effectiveness of analgesics, including opioids.
A version of this article first appeared on Medscape.com.
“In the last decade in Ontario, oxycodone surpassed codeine as the most commonly prescribed opioid postpartum for pain control,” Jonathan Zipursky, MD, PhD, of Sunnybrook Health Sciences Centre, ICES, Toronto, and the University of Toronto, said in an interview. “This likely had to do with concerns with codeine use during breastfeeding, many of which are unsubstantiated.
“We hypothesized that use of oxycodone would be associated with an increased risk of persistent postpartum opioid use,” he said. “However, we did not find this.”
Instead, other factors, such as the quantity of opioids initially prescribed, were probably more important risks, he said.
The team also was “a bit surprised” that oxycodone was associated with an increased risk of persistent use only among those who had a vaginal delivery, Dr. Zipursky added.
“Receipt of an opioid prescription after vaginal delivery is uncommon in Ontario. People who fill prescriptions for potent opioids, such as oxycodone, after vaginal delivery may have underlying characteristics that predispose them to chronic opioid use,” he suggested. “Some of these factors we were unable to assess using our data.”
The study was published online in the Canadian Medical Association Journal.
Oxycodone okay
The investigators analyzed data from 70,607 people (median age, 32) who filled an opioid prescription within 7 days of discharge from the hospital between 2012 and 2020. Two-thirds (69.8%) received oxycodone and one-third received (30.2%) codeine.
The median gestational age at delivery was 39 weeks, and 80% of participants had a cesarean delivery. The median opioid prescription duration was 3 days. The median opioid content per prescription was 150 morphine milligram equivalents (MMEs) among those prescribed oxycodone and 135 MMEs for codeine.
The main outcome was persistent opioid use. This was defined as one or more additional prescriptions for an opioid within 90 days of the first postpartum prescription and one or more additional prescriptions in the 91-365 days after.
Oxycodone receipt was not associated with persistent opioid use, compared with codeine (relative risk, 1.04).
However, in a secondary analysis by mode of delivery, an association was seen between a prescription for oxycodone and persistent use after vaginal (RR, 1.63), but not after cesarean (RR, 0.85), delivery.
Dr. Zipursky noted that the quantity of opioids prescribed in the initial postpartum prescription “is likely a more important modifiable risk factor for new persistent opioid use, rather than the type of opioid prescribed.”
For example, a prescription containing more than 225 MMEs (equivalent to about 30 tablets of 5 mg oxycodone and to 50 tablets of 30 mg codeine) was associated with a roughly twofold increased risk of persistent use, compared with less than 112.5 MMEs after both vaginal (odds ratio, 2.51) and cesarean (OR, 1.78) delivery.
Furthermore, a prescription duration of more than 7 days was also associated with a roughly twofold increased risk of persistent use, compared with a duration of 1-3 days after both vaginal (OR, 2.43) and cesarean (OR, 1.52) delivery.
Most risk factors for persistent opioid use – a history of mental illness, substance use disorder, and more maternal comorbidities (aggregated diagnosis groups > 10) – were consistent across modes of delivery.
“Awareness of modifiable factors associated with new, persistent opioid use may help clinicians tailor opioid prescribing while ensuring adequate analgesia after delivery,” Dr. Zipursky suggested.
Less is more
In a comment, Elaine Duryea, MD, assistant professor in the department of obstetrics and gynecology at UT Southwestern Medical Center and medical director of the Maternal-Fetal Medicine Clinic at Parkland Health and Hospital System, both in Dallas, said, “It is likely exposure to any opioid, rather than a specific opioid, that can promote continued use – that is, past the medically indicated period.”
Dr. Duryea was principal investigator of a study, published in the American Journal of Obstetrics and Gynecology, that showed a multimodal regimen that included scheduled nonsteroidal anti-inflammatory drugs and acetaminophen, with opioids used as needed, resulted in a decrease in opioid use while adequately controlling pain after cesarean delivery.
“It is important to understand how to appropriately tailor the amount of opioid given to patients at the time of hospital discharge after cesarean in order to treat pain effectively but not send patients home with more opioids than [are] really needed,” she said.
It is also important to “individualize prescribing practices and maximize the use of non-opioid medication to treat postpartum and postoperative pain. Opioids should be a last resort for breakthrough pain, not first-line therapy,” Dr. Duryea concluded.
The study was funded by a Canadian Institutes of Health Research project grant. Dr. Zipursky has received payments from private law firms for medicolegal opinions on the safety and effectiveness of analgesics, including opioids.
A version of this article first appeared on Medscape.com.
“In the last decade in Ontario, oxycodone surpassed codeine as the most commonly prescribed opioid postpartum for pain control,” Jonathan Zipursky, MD, PhD, of Sunnybrook Health Sciences Centre, ICES, Toronto, and the University of Toronto, said in an interview. “This likely had to do with concerns with codeine use during breastfeeding, many of which are unsubstantiated.
“We hypothesized that use of oxycodone would be associated with an increased risk of persistent postpartum opioid use,” he said. “However, we did not find this.”
Instead, other factors, such as the quantity of opioids initially prescribed, were probably more important risks, he said.
The team also was “a bit surprised” that oxycodone was associated with an increased risk of persistent use only among those who had a vaginal delivery, Dr. Zipursky added.
“Receipt of an opioid prescription after vaginal delivery is uncommon in Ontario. People who fill prescriptions for potent opioids, such as oxycodone, after vaginal delivery may have underlying characteristics that predispose them to chronic opioid use,” he suggested. “Some of these factors we were unable to assess using our data.”
The study was published online in the Canadian Medical Association Journal.
Oxycodone okay
The investigators analyzed data from 70,607 people (median age, 32) who filled an opioid prescription within 7 days of discharge from the hospital between 2012 and 2020. Two-thirds (69.8%) received oxycodone and one-third received (30.2%) codeine.
The median gestational age at delivery was 39 weeks, and 80% of participants had a cesarean delivery. The median opioid prescription duration was 3 days. The median opioid content per prescription was 150 morphine milligram equivalents (MMEs) among those prescribed oxycodone and 135 MMEs for codeine.
The main outcome was persistent opioid use. This was defined as one or more additional prescriptions for an opioid within 90 days of the first postpartum prescription and one or more additional prescriptions in the 91-365 days after.
Oxycodone receipt was not associated with persistent opioid use, compared with codeine (relative risk, 1.04).
However, in a secondary analysis by mode of delivery, an association was seen between a prescription for oxycodone and persistent use after vaginal (RR, 1.63), but not after cesarean (RR, 0.85), delivery.
Dr. Zipursky noted that the quantity of opioids prescribed in the initial postpartum prescription “is likely a more important modifiable risk factor for new persistent opioid use, rather than the type of opioid prescribed.”
For example, a prescription containing more than 225 MMEs (equivalent to about 30 tablets of 5 mg oxycodone and to 50 tablets of 30 mg codeine) was associated with a roughly twofold increased risk of persistent use, compared with less than 112.5 MMEs after both vaginal (odds ratio, 2.51) and cesarean (OR, 1.78) delivery.
Furthermore, a prescription duration of more than 7 days was also associated with a roughly twofold increased risk of persistent use, compared with a duration of 1-3 days after both vaginal (OR, 2.43) and cesarean (OR, 1.52) delivery.
Most risk factors for persistent opioid use – a history of mental illness, substance use disorder, and more maternal comorbidities (aggregated diagnosis groups > 10) – were consistent across modes of delivery.
“Awareness of modifiable factors associated with new, persistent opioid use may help clinicians tailor opioid prescribing while ensuring adequate analgesia after delivery,” Dr. Zipursky suggested.
Less is more
In a comment, Elaine Duryea, MD, assistant professor in the department of obstetrics and gynecology at UT Southwestern Medical Center and medical director of the Maternal-Fetal Medicine Clinic at Parkland Health and Hospital System, both in Dallas, said, “It is likely exposure to any opioid, rather than a specific opioid, that can promote continued use – that is, past the medically indicated period.”
Dr. Duryea was principal investigator of a study, published in the American Journal of Obstetrics and Gynecology, that showed a multimodal regimen that included scheduled nonsteroidal anti-inflammatory drugs and acetaminophen, with opioids used as needed, resulted in a decrease in opioid use while adequately controlling pain after cesarean delivery.
“It is important to understand how to appropriately tailor the amount of opioid given to patients at the time of hospital discharge after cesarean in order to treat pain effectively but not send patients home with more opioids than [are] really needed,” she said.
It is also important to “individualize prescribing practices and maximize the use of non-opioid medication to treat postpartum and postoperative pain. Opioids should be a last resort for breakthrough pain, not first-line therapy,” Dr. Duryea concluded.
The study was funded by a Canadian Institutes of Health Research project grant. Dr. Zipursky has received payments from private law firms for medicolegal opinions on the safety and effectiveness of analgesics, including opioids.
A version of this article first appeared on Medscape.com.
FROM THE CANADIAN MEDICAL ASSOCIATION JOURNAL
PAD procedure overuse: A field in peril or ‘a few bad apples’?
On May 24, the news outlet ProPublica published a scathing investigation of Jeffery Dormu, DO, said to have performed hundreds of “medically unnecessary and invasive vascular procedures” in his Laurel, Md. office, putting patients’ limbs and lives at risk.
On July 15, The New York Times published a broader-based investigation of several vascular specialists said to have performed “risky” procedures on patients with peripheral artery disease (PAD) who subsequently had to have amputations, or died. The focus was mainly on Michigan-based interventional cardiologist Jihad Mustapha, MD.
This follows a 2019 analysis of Medicare claims data that identified outlier physicians with a high early intervention rate for patients newly diagnosed with claudication. According to the American Heart Association statistics, PAD affects approximately 8.5 million U.S. adults age 40 and older (some claim that’s an underestimate); most cases don’t require invasive treatment.
Responding to the Times’ revelations, Joseph L. Mills, MD, president of the Society for Vascular Surgery, wrote on the society’s website: “The overwhelming majority of vascular surgeons, and a vast majority of other specialists that receive some training and play a role in the care of vascular patients, including those trained in vascular medicine, interventional cardiology, and interventional radiology are providing high-quality, evidence-based care with safety and the best patient outcomes in mind.
“This is a complex issue that requires the examination not only of the events detailed in this story ... but of the underlying health care economic, legal and regulatory policies that created fertile soil for this behavior to germinate and take root.”
‘A few bad apples’
“I think it’s a case of a few bad apples,” Sunil V. Rao, MD, director of interventional cardiology at NYU Langone Health, New York, said in an interview. “In general, I think physicians who take care of patients with vascular issues are trying to do the right thing. I think all of us who take care of patients with vascular disease see patients who are very, very complex, and there are going to be some procedures that have complications.
“Without knowing the clinical details, it’s hard to know whether the procedures described in the articles were overuse or unnecessary, or exactly what led to the amputations,” he said. “All we know is that these physicians are outliers in terms of the number of procedures they were billing for.
“But although correlation is not causation, it certainly is cause for concern because you would expect that the use of procedures for specific indications would fall within a certain range,” he added.
Lifestyle changes first
PAD is often asymptomatic or mild, making it difficult to diagnose. Revascularization procedures usually are reserved for the 5%-8% of patients at risk for chronic limb-threatening ischemia (CLTI) or those in whom the cornerstones of PAD treatment – lifestyle changes and, if needed, medication – fail.
Revascularization options include balloon angioplasty or stent placement; atherectomy to remove plaques from the artery; or bypass surgery if a long portion of a leg artery is completely blocked. All carry a risk of long-term adverse outcomes, but the rates are highest for atherectomy.
Lifestyle changes include regular exercise, following a healthy diet, quitting smoking, and controlling diabetes and high blood pressure. When PAD continues or progresses despite these modifications, medications such as antiplatelet agents, antihypertensives, and/or lipid-lowering drugs may be prescribed.
‘Medically unnecessary’
According to the latest American Heart Association/American College of Cardiology guideline on managing patients with lower-extremity PAD, patients should be selected for revascularization based on symptom severity.
Factors to consider include a significant disability as assessed by the patient, and adequacy of response to medical and structured exercise therapy.
There’s the rub regarding the clinicians investigated in the Times and ProPublica. Many patients, apparently, were not encouraged to make lifestyle changes, nor did they receive medication. Instead, they were advised from the get-go to undergo invasive procedures, and often multiple times. Underuse of prevention and lifestyle counseling n the management of PAD has long been a concern.
Furthermore, in at least some cases, patients without any symptoms were encouraged to be screened for blockages that were then treated invasively, according to the Times.
Dr. Dormu, as highlighted in ProPublica, positioned his practice as “life and limb saving.” Yet, in investigative findings that led to a suspension of Dr. Dormu’s license to practice medicine in Maryland, peer reviewers expressed concern regarding his repeated use of invasive and medically unnecessary procedures, exposing patients to “potential risks such as bleeding, infection, blood vessel injuries which could acutely or chronically worsen the patient’s circulation, and limb loss.”
The peer reviewers concurred that Dr. Dormu failed to use conservative management techniques to address the patients’ vascular complaints before resorting to invasive procedures.
Dr. Mustapha is described in the Times as a “high-volume” atherectomy provider. From 2017 to 2021, about half of Medicare’s atherectomy payments – $1.4 billion – went to 200 high-volume providers, with Dr. Mustapha near the top of the list.
Some of Dr. Mustapha’s patients underwent multiple procedures said to help prevent leg amputation, but their legs were amputated anyway, possibly because of the multiple atherectomies, according to the Times.
Judith Lin, MD, MBA, who treated some of Dr. Mustapha’s former patients, was among those who complained about his practice to Michigan’s licensing board. Some of the patients she treated needed amputations; others needed to have leftover wires extracted from their legs.
In 2020, the board investigated Dr. Lin’s complaint and referred it to Michigan’s attorney general, who brought a disciplinary action against Dr. Mustapha. An expert hired by the state to review eight patient cases concluded that Dr. Mustapha’s practice “was characterized by overtreatment and poor documentation.” In some cases, the expert wrote, “unnecessary procedures hastened amputations.”
The statement issued by Dr. Mills, the president of SVS, noted that the society’s practice guideline proposes a threshold of at least 2 years of likely durability for an intervention performed for claudication.
“The growing frequency of multiple, repeated procedures [is] emblematic of poor patient selection and inadequate durability of the chosen procedure, leading to a vicious cycle of repetitive interventions that is not only costly, but also dangerous,” he wrote.
Financial incentives to blame?
In 2008, Medicare created incentives for physicians to perform vascular procedures in offices rather than hospitals, in an effort to reduce medical costs, according to both investigative articles. But the effort backfired.
Before the changes, an office provider inserting a stent could make about $1,700 from Medicare; deploying a balloon could bring in roughly $3,800. By 2011, the payments rose to about $6,400 and $4,800, respectively.
Office-based atherectomies soared when, in 2011, the Centers for Medicare & Medicaid Services started reimbursing $13,500 per procedure, as opposed to roughly $11,450 in a hospital. Atherectomies increased by 60% from 2011 to 2014, and Medicare’s overall costs for peripheral vascular treatments climbed by nearly half a billion dollars.
“The government is really to blame for setting these tremendously high reimbursement values without looking into whether these procedures are helping people or are just worthless procedures or, in fact, are hurting people,” Dipankar Mukherjee, MD, a vascular surgeon and chief of vascular surgery at Inova Fairfax (Va.) Hospital, said in ProPublica.
The result, noted Dr. Rao, is that “there can be perverse or nefarious incentives for doing these procedures. People are incentivized by reimbursement to do something that really falls in the area of clinical judgment and guidelines.”
Major incentives also come from device manufacturers, who often reward physicians who do the most vascular procedures with payments for consulting and other services, according to the Times. In addition, these companies lend money to help physicians or their clinics to finance the purchase of equipment used to perform the procedures.
“Vascular medicine now is the frontier of the Wild West,” Marty Makary, MD, MPH, a professor of surgery and health care quality researcher at Johns Hopkins University, Baltimore, told ProPublica. “People are flying blind walking into the clinics of these doctors with egregious practice patterns, and we know that their pattern is indefensible.”
Recognizing that the situation posed a threat to patients and also damaged the credibility of his specialty, Kim J. Hodgson, MD, a former SVS president, told attendees at the 2021 annual meeting of the SVS, “Somebody has to address what should never have been allowed to get to this level of threat to us and our patients in the first place. We can play whack-a-mole every time the bad actors surface until the cows come home, but that leaves a trail of harmed patients and wasted resources.”
Dr. Hodgson described atherectomy as “a procedure that many believe provides no demonstrable value whatsoever to the patient” and challenged those who disagree to prove it.
Multidisciplinary teams needed
Other experts believe there are times that revascularization procedures, including atherectomy, are appropriate. However, the majority of patients with PAD do not require a procedure, Soo Hyun (Esther) Kim, MD, MPH, director of the Center for Women’s Cardiovascular Health at Atrium Health Sanger Heart and Vascular Institute in Charlotte, N.C., said in an interview. In fact, “many patients do not even know they have leg artery blockages.”
Invasive procedures may well be appropriate for patients with severe PAD, especially those with CLTI, and disparities may be keeping those who truly need such interventions – or for whom they may be at least considered – from accessing them. If PAD is not diagnosed and treated in a timely way, Dr. Kim said, those individuals “do indeed lose their limbs.”
Multidisciplinary teams can help, Dr. Kim said. “Specialists from multiple different training backgrounds [can] take good care of patients with PAD,” she said. This is important when access to a particular type of specialist is limited, and because patients with PAD often have complex medical problems that can benefit from a team approach.
Transcatheter aortic valve replacement heart teams and complex coronary disease heart teams are two examples, Dr. Kim noted. “When a high-stakes procedure is being considered, the patient’s case is reviewed by multiple stakeholders to ensure appropriateness of the procedure and collaboratively evaluate risk.”
Dr. Rao also emphasized a team approach. “PAD does not belong to a single specialty,” he said. The revelations from the Times, ProPublica, and other sources “point to the fact that we all – cardiologists, vascular surgeons, interventional radiologists – should start thinking about how best to police ourselves and also account for the variation in clinical judgment.”
Use of a multidisciplinary team is a “guideline-recommended approach” for coronary artery revascularization, he said, “I think the same should apply for PAD.”
PAD is a sign of systemic atherosclerosis, Dr. Kim noted. “The treatment of PAD includes addressing leg pain and wounds with procedures, but the interventions that will keep people alive are the medications we use to prevent heart attack and stroke. Patients with PAD need to understand that treatment is much more than opening up a blockage in the leg.”
Dr. Rao and Dr. Kim disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
On May 24, the news outlet ProPublica published a scathing investigation of Jeffery Dormu, DO, said to have performed hundreds of “medically unnecessary and invasive vascular procedures” in his Laurel, Md. office, putting patients’ limbs and lives at risk.
On July 15, The New York Times published a broader-based investigation of several vascular specialists said to have performed “risky” procedures on patients with peripheral artery disease (PAD) who subsequently had to have amputations, or died. The focus was mainly on Michigan-based interventional cardiologist Jihad Mustapha, MD.
This follows a 2019 analysis of Medicare claims data that identified outlier physicians with a high early intervention rate for patients newly diagnosed with claudication. According to the American Heart Association statistics, PAD affects approximately 8.5 million U.S. adults age 40 and older (some claim that’s an underestimate); most cases don’t require invasive treatment.
Responding to the Times’ revelations, Joseph L. Mills, MD, president of the Society for Vascular Surgery, wrote on the society’s website: “The overwhelming majority of vascular surgeons, and a vast majority of other specialists that receive some training and play a role in the care of vascular patients, including those trained in vascular medicine, interventional cardiology, and interventional radiology are providing high-quality, evidence-based care with safety and the best patient outcomes in mind.
“This is a complex issue that requires the examination not only of the events detailed in this story ... but of the underlying health care economic, legal and regulatory policies that created fertile soil for this behavior to germinate and take root.”
‘A few bad apples’
“I think it’s a case of a few bad apples,” Sunil V. Rao, MD, director of interventional cardiology at NYU Langone Health, New York, said in an interview. “In general, I think physicians who take care of patients with vascular issues are trying to do the right thing. I think all of us who take care of patients with vascular disease see patients who are very, very complex, and there are going to be some procedures that have complications.
“Without knowing the clinical details, it’s hard to know whether the procedures described in the articles were overuse or unnecessary, or exactly what led to the amputations,” he said. “All we know is that these physicians are outliers in terms of the number of procedures they were billing for.
“But although correlation is not causation, it certainly is cause for concern because you would expect that the use of procedures for specific indications would fall within a certain range,” he added.
Lifestyle changes first
PAD is often asymptomatic or mild, making it difficult to diagnose. Revascularization procedures usually are reserved for the 5%-8% of patients at risk for chronic limb-threatening ischemia (CLTI) or those in whom the cornerstones of PAD treatment – lifestyle changes and, if needed, medication – fail.
Revascularization options include balloon angioplasty or stent placement; atherectomy to remove plaques from the artery; or bypass surgery if a long portion of a leg artery is completely blocked. All carry a risk of long-term adverse outcomes, but the rates are highest for atherectomy.
Lifestyle changes include regular exercise, following a healthy diet, quitting smoking, and controlling diabetes and high blood pressure. When PAD continues or progresses despite these modifications, medications such as antiplatelet agents, antihypertensives, and/or lipid-lowering drugs may be prescribed.
‘Medically unnecessary’
According to the latest American Heart Association/American College of Cardiology guideline on managing patients with lower-extremity PAD, patients should be selected for revascularization based on symptom severity.
Factors to consider include a significant disability as assessed by the patient, and adequacy of response to medical and structured exercise therapy.
There’s the rub regarding the clinicians investigated in the Times and ProPublica. Many patients, apparently, were not encouraged to make lifestyle changes, nor did they receive medication. Instead, they were advised from the get-go to undergo invasive procedures, and often multiple times. Underuse of prevention and lifestyle counseling n the management of PAD has long been a concern.
Furthermore, in at least some cases, patients without any symptoms were encouraged to be screened for blockages that were then treated invasively, according to the Times.
Dr. Dormu, as highlighted in ProPublica, positioned his practice as “life and limb saving.” Yet, in investigative findings that led to a suspension of Dr. Dormu’s license to practice medicine in Maryland, peer reviewers expressed concern regarding his repeated use of invasive and medically unnecessary procedures, exposing patients to “potential risks such as bleeding, infection, blood vessel injuries which could acutely or chronically worsen the patient’s circulation, and limb loss.”
The peer reviewers concurred that Dr. Dormu failed to use conservative management techniques to address the patients’ vascular complaints before resorting to invasive procedures.
Dr. Mustapha is described in the Times as a “high-volume” atherectomy provider. From 2017 to 2021, about half of Medicare’s atherectomy payments – $1.4 billion – went to 200 high-volume providers, with Dr. Mustapha near the top of the list.
Some of Dr. Mustapha’s patients underwent multiple procedures said to help prevent leg amputation, but their legs were amputated anyway, possibly because of the multiple atherectomies, according to the Times.
Judith Lin, MD, MBA, who treated some of Dr. Mustapha’s former patients, was among those who complained about his practice to Michigan’s licensing board. Some of the patients she treated needed amputations; others needed to have leftover wires extracted from their legs.
In 2020, the board investigated Dr. Lin’s complaint and referred it to Michigan’s attorney general, who brought a disciplinary action against Dr. Mustapha. An expert hired by the state to review eight patient cases concluded that Dr. Mustapha’s practice “was characterized by overtreatment and poor documentation.” In some cases, the expert wrote, “unnecessary procedures hastened amputations.”
The statement issued by Dr. Mills, the president of SVS, noted that the society’s practice guideline proposes a threshold of at least 2 years of likely durability for an intervention performed for claudication.
“The growing frequency of multiple, repeated procedures [is] emblematic of poor patient selection and inadequate durability of the chosen procedure, leading to a vicious cycle of repetitive interventions that is not only costly, but also dangerous,” he wrote.
Financial incentives to blame?
In 2008, Medicare created incentives for physicians to perform vascular procedures in offices rather than hospitals, in an effort to reduce medical costs, according to both investigative articles. But the effort backfired.
Before the changes, an office provider inserting a stent could make about $1,700 from Medicare; deploying a balloon could bring in roughly $3,800. By 2011, the payments rose to about $6,400 and $4,800, respectively.
Office-based atherectomies soared when, in 2011, the Centers for Medicare & Medicaid Services started reimbursing $13,500 per procedure, as opposed to roughly $11,450 in a hospital. Atherectomies increased by 60% from 2011 to 2014, and Medicare’s overall costs for peripheral vascular treatments climbed by nearly half a billion dollars.
“The government is really to blame for setting these tremendously high reimbursement values without looking into whether these procedures are helping people or are just worthless procedures or, in fact, are hurting people,” Dipankar Mukherjee, MD, a vascular surgeon and chief of vascular surgery at Inova Fairfax (Va.) Hospital, said in ProPublica.
The result, noted Dr. Rao, is that “there can be perverse or nefarious incentives for doing these procedures. People are incentivized by reimbursement to do something that really falls in the area of clinical judgment and guidelines.”
Major incentives also come from device manufacturers, who often reward physicians who do the most vascular procedures with payments for consulting and other services, according to the Times. In addition, these companies lend money to help physicians or their clinics to finance the purchase of equipment used to perform the procedures.
“Vascular medicine now is the frontier of the Wild West,” Marty Makary, MD, MPH, a professor of surgery and health care quality researcher at Johns Hopkins University, Baltimore, told ProPublica. “People are flying blind walking into the clinics of these doctors with egregious practice patterns, and we know that their pattern is indefensible.”
Recognizing that the situation posed a threat to patients and also damaged the credibility of his specialty, Kim J. Hodgson, MD, a former SVS president, told attendees at the 2021 annual meeting of the SVS, “Somebody has to address what should never have been allowed to get to this level of threat to us and our patients in the first place. We can play whack-a-mole every time the bad actors surface until the cows come home, but that leaves a trail of harmed patients and wasted resources.”
Dr. Hodgson described atherectomy as “a procedure that many believe provides no demonstrable value whatsoever to the patient” and challenged those who disagree to prove it.
Multidisciplinary teams needed
Other experts believe there are times that revascularization procedures, including atherectomy, are appropriate. However, the majority of patients with PAD do not require a procedure, Soo Hyun (Esther) Kim, MD, MPH, director of the Center for Women’s Cardiovascular Health at Atrium Health Sanger Heart and Vascular Institute in Charlotte, N.C., said in an interview. In fact, “many patients do not even know they have leg artery blockages.”
Invasive procedures may well be appropriate for patients with severe PAD, especially those with CLTI, and disparities may be keeping those who truly need such interventions – or for whom they may be at least considered – from accessing them. If PAD is not diagnosed and treated in a timely way, Dr. Kim said, those individuals “do indeed lose their limbs.”
Multidisciplinary teams can help, Dr. Kim said. “Specialists from multiple different training backgrounds [can] take good care of patients with PAD,” she said. This is important when access to a particular type of specialist is limited, and because patients with PAD often have complex medical problems that can benefit from a team approach.
Transcatheter aortic valve replacement heart teams and complex coronary disease heart teams are two examples, Dr. Kim noted. “When a high-stakes procedure is being considered, the patient’s case is reviewed by multiple stakeholders to ensure appropriateness of the procedure and collaboratively evaluate risk.”
Dr. Rao also emphasized a team approach. “PAD does not belong to a single specialty,” he said. The revelations from the Times, ProPublica, and other sources “point to the fact that we all – cardiologists, vascular surgeons, interventional radiologists – should start thinking about how best to police ourselves and also account for the variation in clinical judgment.”
Use of a multidisciplinary team is a “guideline-recommended approach” for coronary artery revascularization, he said, “I think the same should apply for PAD.”
PAD is a sign of systemic atherosclerosis, Dr. Kim noted. “The treatment of PAD includes addressing leg pain and wounds with procedures, but the interventions that will keep people alive are the medications we use to prevent heart attack and stroke. Patients with PAD need to understand that treatment is much more than opening up a blockage in the leg.”
Dr. Rao and Dr. Kim disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
On May 24, the news outlet ProPublica published a scathing investigation of Jeffery Dormu, DO, said to have performed hundreds of “medically unnecessary and invasive vascular procedures” in his Laurel, Md. office, putting patients’ limbs and lives at risk.
On July 15, The New York Times published a broader-based investigation of several vascular specialists said to have performed “risky” procedures on patients with peripheral artery disease (PAD) who subsequently had to have amputations, or died. The focus was mainly on Michigan-based interventional cardiologist Jihad Mustapha, MD.
This follows a 2019 analysis of Medicare claims data that identified outlier physicians with a high early intervention rate for patients newly diagnosed with claudication. According to the American Heart Association statistics, PAD affects approximately 8.5 million U.S. adults age 40 and older (some claim that’s an underestimate); most cases don’t require invasive treatment.
Responding to the Times’ revelations, Joseph L. Mills, MD, president of the Society for Vascular Surgery, wrote on the society’s website: “The overwhelming majority of vascular surgeons, and a vast majority of other specialists that receive some training and play a role in the care of vascular patients, including those trained in vascular medicine, interventional cardiology, and interventional radiology are providing high-quality, evidence-based care with safety and the best patient outcomes in mind.
“This is a complex issue that requires the examination not only of the events detailed in this story ... but of the underlying health care economic, legal and regulatory policies that created fertile soil for this behavior to germinate and take root.”
‘A few bad apples’
“I think it’s a case of a few bad apples,” Sunil V. Rao, MD, director of interventional cardiology at NYU Langone Health, New York, said in an interview. “In general, I think physicians who take care of patients with vascular issues are trying to do the right thing. I think all of us who take care of patients with vascular disease see patients who are very, very complex, and there are going to be some procedures that have complications.
“Without knowing the clinical details, it’s hard to know whether the procedures described in the articles were overuse or unnecessary, or exactly what led to the amputations,” he said. “All we know is that these physicians are outliers in terms of the number of procedures they were billing for.
“But although correlation is not causation, it certainly is cause for concern because you would expect that the use of procedures for specific indications would fall within a certain range,” he added.
Lifestyle changes first
PAD is often asymptomatic or mild, making it difficult to diagnose. Revascularization procedures usually are reserved for the 5%-8% of patients at risk for chronic limb-threatening ischemia (CLTI) or those in whom the cornerstones of PAD treatment – lifestyle changes and, if needed, medication – fail.
Revascularization options include balloon angioplasty or stent placement; atherectomy to remove plaques from the artery; or bypass surgery if a long portion of a leg artery is completely blocked. All carry a risk of long-term adverse outcomes, but the rates are highest for atherectomy.
Lifestyle changes include regular exercise, following a healthy diet, quitting smoking, and controlling diabetes and high blood pressure. When PAD continues or progresses despite these modifications, medications such as antiplatelet agents, antihypertensives, and/or lipid-lowering drugs may be prescribed.
‘Medically unnecessary’
According to the latest American Heart Association/American College of Cardiology guideline on managing patients with lower-extremity PAD, patients should be selected for revascularization based on symptom severity.
Factors to consider include a significant disability as assessed by the patient, and adequacy of response to medical and structured exercise therapy.
There’s the rub regarding the clinicians investigated in the Times and ProPublica. Many patients, apparently, were not encouraged to make lifestyle changes, nor did they receive medication. Instead, they were advised from the get-go to undergo invasive procedures, and often multiple times. Underuse of prevention and lifestyle counseling n the management of PAD has long been a concern.
Furthermore, in at least some cases, patients without any symptoms were encouraged to be screened for blockages that were then treated invasively, according to the Times.
Dr. Dormu, as highlighted in ProPublica, positioned his practice as “life and limb saving.” Yet, in investigative findings that led to a suspension of Dr. Dormu’s license to practice medicine in Maryland, peer reviewers expressed concern regarding his repeated use of invasive and medically unnecessary procedures, exposing patients to “potential risks such as bleeding, infection, blood vessel injuries which could acutely or chronically worsen the patient’s circulation, and limb loss.”
The peer reviewers concurred that Dr. Dormu failed to use conservative management techniques to address the patients’ vascular complaints before resorting to invasive procedures.
Dr. Mustapha is described in the Times as a “high-volume” atherectomy provider. From 2017 to 2021, about half of Medicare’s atherectomy payments – $1.4 billion – went to 200 high-volume providers, with Dr. Mustapha near the top of the list.
Some of Dr. Mustapha’s patients underwent multiple procedures said to help prevent leg amputation, but their legs were amputated anyway, possibly because of the multiple atherectomies, according to the Times.
Judith Lin, MD, MBA, who treated some of Dr. Mustapha’s former patients, was among those who complained about his practice to Michigan’s licensing board. Some of the patients she treated needed amputations; others needed to have leftover wires extracted from their legs.
In 2020, the board investigated Dr. Lin’s complaint and referred it to Michigan’s attorney general, who brought a disciplinary action against Dr. Mustapha. An expert hired by the state to review eight patient cases concluded that Dr. Mustapha’s practice “was characterized by overtreatment and poor documentation.” In some cases, the expert wrote, “unnecessary procedures hastened amputations.”
The statement issued by Dr. Mills, the president of SVS, noted that the society’s practice guideline proposes a threshold of at least 2 years of likely durability for an intervention performed for claudication.
“The growing frequency of multiple, repeated procedures [is] emblematic of poor patient selection and inadequate durability of the chosen procedure, leading to a vicious cycle of repetitive interventions that is not only costly, but also dangerous,” he wrote.
Financial incentives to blame?
In 2008, Medicare created incentives for physicians to perform vascular procedures in offices rather than hospitals, in an effort to reduce medical costs, according to both investigative articles. But the effort backfired.
Before the changes, an office provider inserting a stent could make about $1,700 from Medicare; deploying a balloon could bring in roughly $3,800. By 2011, the payments rose to about $6,400 and $4,800, respectively.
Office-based atherectomies soared when, in 2011, the Centers for Medicare & Medicaid Services started reimbursing $13,500 per procedure, as opposed to roughly $11,450 in a hospital. Atherectomies increased by 60% from 2011 to 2014, and Medicare’s overall costs for peripheral vascular treatments climbed by nearly half a billion dollars.
“The government is really to blame for setting these tremendously high reimbursement values without looking into whether these procedures are helping people or are just worthless procedures or, in fact, are hurting people,” Dipankar Mukherjee, MD, a vascular surgeon and chief of vascular surgery at Inova Fairfax (Va.) Hospital, said in ProPublica.
The result, noted Dr. Rao, is that “there can be perverse or nefarious incentives for doing these procedures. People are incentivized by reimbursement to do something that really falls in the area of clinical judgment and guidelines.”
Major incentives also come from device manufacturers, who often reward physicians who do the most vascular procedures with payments for consulting and other services, according to the Times. In addition, these companies lend money to help physicians or their clinics to finance the purchase of equipment used to perform the procedures.
“Vascular medicine now is the frontier of the Wild West,” Marty Makary, MD, MPH, a professor of surgery and health care quality researcher at Johns Hopkins University, Baltimore, told ProPublica. “People are flying blind walking into the clinics of these doctors with egregious practice patterns, and we know that their pattern is indefensible.”
Recognizing that the situation posed a threat to patients and also damaged the credibility of his specialty, Kim J. Hodgson, MD, a former SVS president, told attendees at the 2021 annual meeting of the SVS, “Somebody has to address what should never have been allowed to get to this level of threat to us and our patients in the first place. We can play whack-a-mole every time the bad actors surface until the cows come home, but that leaves a trail of harmed patients and wasted resources.”
Dr. Hodgson described atherectomy as “a procedure that many believe provides no demonstrable value whatsoever to the patient” and challenged those who disagree to prove it.
Multidisciplinary teams needed
Other experts believe there are times that revascularization procedures, including atherectomy, are appropriate. However, the majority of patients with PAD do not require a procedure, Soo Hyun (Esther) Kim, MD, MPH, director of the Center for Women’s Cardiovascular Health at Atrium Health Sanger Heart and Vascular Institute in Charlotte, N.C., said in an interview. In fact, “many patients do not even know they have leg artery blockages.”
Invasive procedures may well be appropriate for patients with severe PAD, especially those with CLTI, and disparities may be keeping those who truly need such interventions – or for whom they may be at least considered – from accessing them. If PAD is not diagnosed and treated in a timely way, Dr. Kim said, those individuals “do indeed lose their limbs.”
Multidisciplinary teams can help, Dr. Kim said. “Specialists from multiple different training backgrounds [can] take good care of patients with PAD,” she said. This is important when access to a particular type of specialist is limited, and because patients with PAD often have complex medical problems that can benefit from a team approach.
Transcatheter aortic valve replacement heart teams and complex coronary disease heart teams are two examples, Dr. Kim noted. “When a high-stakes procedure is being considered, the patient’s case is reviewed by multiple stakeholders to ensure appropriateness of the procedure and collaboratively evaluate risk.”
Dr. Rao also emphasized a team approach. “PAD does not belong to a single specialty,” he said. The revelations from the Times, ProPublica, and other sources “point to the fact that we all – cardiologists, vascular surgeons, interventional radiologists – should start thinking about how best to police ourselves and also account for the variation in clinical judgment.”
Use of a multidisciplinary team is a “guideline-recommended approach” for coronary artery revascularization, he said, “I think the same should apply for PAD.”
PAD is a sign of systemic atherosclerosis, Dr. Kim noted. “The treatment of PAD includes addressing leg pain and wounds with procedures, but the interventions that will keep people alive are the medications we use to prevent heart attack and stroke. Patients with PAD need to understand that treatment is much more than opening up a blockage in the leg.”
Dr. Rao and Dr. Kim disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Higher step counts tied to fewer symptoms in HF
Daily step counts between 1,000 and 5,000 were significantly associated with symptoms and physical limitations, as reflected in Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom (TS) and physical limitation (PL) scores.
Participants whose step counts increased by 2,000 steps per day demonstrated a 5.2-point increase in their KCCQ-TS scores and a 5.33-point increase in their KCCQ-PL scores, with higher scores reflecting improvement.
However, declines in step counts were not associated with significant declines in KCCQ-PL scores.
The findings are not yet ready to be implemented into practice, first author Jessica R. Golbus, MD, of the University of Michigan, Ann Arbor, said in an interview. However, she said, they “suggest that clinicians should interpret improvements in step counts as indicative of improving health status, though they should not necessarily be as concerned with reductions in step count.
“I would certainly, however, still encourage clinicians to discuss decrementing physical activity levels with their patients, though an intervention may not necessarily be warranted,” she added.
The study was published online in JACC: Heart Failure.
Nonlinear relationship
The investigators analyzed data from the Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF) trial, a randomized, controlled trial that enrolled participants with heart failure who had a smartphone.
Participants were given a Fitbit Versa 2 and completed serial KCCQs via the smartphone app.
The researchers assessed the relationship between daily step count and KCCQ-TS and KCCQ-PL scores at baseline, as well as changes in the scores between 2 and 12 weeks.
The study included 425 patients. The mean age was 63.5 years, 44.5% were women, and 83.3% were White; 40.9% had reduced ejection fraction, 59.1% had preserved ejection fraction, and 27.5% had type 2 diabetes.
At 2 weeks, the mean KCCQ-TS score was 62.7, and the mean KCCQ-PL score was 55.7.
KCCQ-TS scores increased by 2.5 points on average, and KCCQ-PL scores by 4 points through 12 weeks.
When categorized by 25-point ranges, the step count increased with increasing scores for both KCCQ-TS and KCCQ-PL. Those with KCCQ-TS scores of 0-24 averaged 2,437.6 steps daily, and those with scores of 75-100 averaged 4,870.9 steps daily.
Similarly, participants with KCCQ-PL scores of 0-24 averaged 2301.5 steps daily, and those with scores of 75-100 averaged 5,351.9. The relationship remained significant after adjustment.
There were nonlinear relationships between activity and KCCQ scores: Daily step counts below 5,000 steps were associated with KCCQ scores, but there was little association with counts above 5,000 steps.
Compared with participants who walked 2,000 steps per day, those who walked 1,000 had KCCQ-TS scores that were 3.11 points lower; participants who walked 3,000 had KCCQ-TS scores that were 2.89 points higher.
Similarly, participants who walked 1,000 steps per day had KCCQ-PL scores that were 5.36 points lower than those who walked 2,000 steps, and those who walked 3,000 steps had KCCQ-PL scores that were 4.97 points higher.
After adjustment, change in daily step counts was significantly associated with a change in KCCQ-PL scores from baseline through 12 weeks; for example, participants whose step counts increased by 2,000 steps per day experienced a 5.33 increase in their KCCQ-PL scores relative to participants whose step counts did not change.
‘New kid on the block’
Frederick Ho, PhD, a lecturer in public health at the University of Glasgow (Scotland), who is a volunteer spokesperson for the American Heart Association, called the study “promising.”
“The study follow-up is relatively short, so it is not known whether the association is valid longer term,” he said in an interview. “It is also possible that patients with more severe symptoms became physically less active, and at the same time had worse outcomes.
“A study with longer follow-up among patients from a broader background would provide confidence on the generalizability of the findings,” said Dr. Ho, who led a recent study that showed accelerometer-measured physical activity was associated with a lower risk of heart failure. “It’d also be interesting to validate the findings using different types of wearable devices.”
Previous studies have shown that wrist-worn wearables might overestimate light-intensity activities, compared with hip-worn devices, he noted. “I’d imagine that the findings would be slightly different due to different types of devices, but the overall premise should remain.”
In a related editorial, Mitchell Psotka, MD, PhD, writes that Dr. Golbus and colleagues “have thankfully moved our understanding of actigraphy forward, although it is still the new kid on the block and will require substantial further testing and validation before widespread reliable clinical and research use.”
Terminology and reporting features need to be standardized, and preferred methods of implementation need to be established, including how to wear the devices, he suggests.
Further research is needed to validate that “accelerometers and their digitally processed movement ‘counts’ actually measure activity and that this measured activity has clinical relevance.”
The study did not receive commercial funding. Dr. Golbus, Dr. Ho, and Dr. Psotka report no relevant relationships.
A version of this article first appeared on Medscape.com.
Daily step counts between 1,000 and 5,000 were significantly associated with symptoms and physical limitations, as reflected in Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom (TS) and physical limitation (PL) scores.
Participants whose step counts increased by 2,000 steps per day demonstrated a 5.2-point increase in their KCCQ-TS scores and a 5.33-point increase in their KCCQ-PL scores, with higher scores reflecting improvement.
However, declines in step counts were not associated with significant declines in KCCQ-PL scores.
The findings are not yet ready to be implemented into practice, first author Jessica R. Golbus, MD, of the University of Michigan, Ann Arbor, said in an interview. However, she said, they “suggest that clinicians should interpret improvements in step counts as indicative of improving health status, though they should not necessarily be as concerned with reductions in step count.
“I would certainly, however, still encourage clinicians to discuss decrementing physical activity levels with their patients, though an intervention may not necessarily be warranted,” she added.
The study was published online in JACC: Heart Failure.
Nonlinear relationship
The investigators analyzed data from the Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF) trial, a randomized, controlled trial that enrolled participants with heart failure who had a smartphone.
Participants were given a Fitbit Versa 2 and completed serial KCCQs via the smartphone app.
The researchers assessed the relationship between daily step count and KCCQ-TS and KCCQ-PL scores at baseline, as well as changes in the scores between 2 and 12 weeks.
The study included 425 patients. The mean age was 63.5 years, 44.5% were women, and 83.3% were White; 40.9% had reduced ejection fraction, 59.1% had preserved ejection fraction, and 27.5% had type 2 diabetes.
At 2 weeks, the mean KCCQ-TS score was 62.7, and the mean KCCQ-PL score was 55.7.
KCCQ-TS scores increased by 2.5 points on average, and KCCQ-PL scores by 4 points through 12 weeks.
When categorized by 25-point ranges, the step count increased with increasing scores for both KCCQ-TS and KCCQ-PL. Those with KCCQ-TS scores of 0-24 averaged 2,437.6 steps daily, and those with scores of 75-100 averaged 4,870.9 steps daily.
Similarly, participants with KCCQ-PL scores of 0-24 averaged 2301.5 steps daily, and those with scores of 75-100 averaged 5,351.9. The relationship remained significant after adjustment.
There were nonlinear relationships between activity and KCCQ scores: Daily step counts below 5,000 steps were associated with KCCQ scores, but there was little association with counts above 5,000 steps.
Compared with participants who walked 2,000 steps per day, those who walked 1,000 had KCCQ-TS scores that were 3.11 points lower; participants who walked 3,000 had KCCQ-TS scores that were 2.89 points higher.
Similarly, participants who walked 1,000 steps per day had KCCQ-PL scores that were 5.36 points lower than those who walked 2,000 steps, and those who walked 3,000 steps had KCCQ-PL scores that were 4.97 points higher.
After adjustment, change in daily step counts was significantly associated with a change in KCCQ-PL scores from baseline through 12 weeks; for example, participants whose step counts increased by 2,000 steps per day experienced a 5.33 increase in their KCCQ-PL scores relative to participants whose step counts did not change.
‘New kid on the block’
Frederick Ho, PhD, a lecturer in public health at the University of Glasgow (Scotland), who is a volunteer spokesperson for the American Heart Association, called the study “promising.”
“The study follow-up is relatively short, so it is not known whether the association is valid longer term,” he said in an interview. “It is also possible that patients with more severe symptoms became physically less active, and at the same time had worse outcomes.
“A study with longer follow-up among patients from a broader background would provide confidence on the generalizability of the findings,” said Dr. Ho, who led a recent study that showed accelerometer-measured physical activity was associated with a lower risk of heart failure. “It’d also be interesting to validate the findings using different types of wearable devices.”
Previous studies have shown that wrist-worn wearables might overestimate light-intensity activities, compared with hip-worn devices, he noted. “I’d imagine that the findings would be slightly different due to different types of devices, but the overall premise should remain.”
In a related editorial, Mitchell Psotka, MD, PhD, writes that Dr. Golbus and colleagues “have thankfully moved our understanding of actigraphy forward, although it is still the new kid on the block and will require substantial further testing and validation before widespread reliable clinical and research use.”
Terminology and reporting features need to be standardized, and preferred methods of implementation need to be established, including how to wear the devices, he suggests.
Further research is needed to validate that “accelerometers and their digitally processed movement ‘counts’ actually measure activity and that this measured activity has clinical relevance.”
The study did not receive commercial funding. Dr. Golbus, Dr. Ho, and Dr. Psotka report no relevant relationships.
A version of this article first appeared on Medscape.com.
Daily step counts between 1,000 and 5,000 were significantly associated with symptoms and physical limitations, as reflected in Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom (TS) and physical limitation (PL) scores.
Participants whose step counts increased by 2,000 steps per day demonstrated a 5.2-point increase in their KCCQ-TS scores and a 5.33-point increase in their KCCQ-PL scores, with higher scores reflecting improvement.
However, declines in step counts were not associated with significant declines in KCCQ-PL scores.
The findings are not yet ready to be implemented into practice, first author Jessica R. Golbus, MD, of the University of Michigan, Ann Arbor, said in an interview. However, she said, they “suggest that clinicians should interpret improvements in step counts as indicative of improving health status, though they should not necessarily be as concerned with reductions in step count.
“I would certainly, however, still encourage clinicians to discuss decrementing physical activity levels with their patients, though an intervention may not necessarily be warranted,” she added.
The study was published online in JACC: Heart Failure.
Nonlinear relationship
The investigators analyzed data from the Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF) trial, a randomized, controlled trial that enrolled participants with heart failure who had a smartphone.
Participants were given a Fitbit Versa 2 and completed serial KCCQs via the smartphone app.
The researchers assessed the relationship between daily step count and KCCQ-TS and KCCQ-PL scores at baseline, as well as changes in the scores between 2 and 12 weeks.
The study included 425 patients. The mean age was 63.5 years, 44.5% were women, and 83.3% were White; 40.9% had reduced ejection fraction, 59.1% had preserved ejection fraction, and 27.5% had type 2 diabetes.
At 2 weeks, the mean KCCQ-TS score was 62.7, and the mean KCCQ-PL score was 55.7.
KCCQ-TS scores increased by 2.5 points on average, and KCCQ-PL scores by 4 points through 12 weeks.
When categorized by 25-point ranges, the step count increased with increasing scores for both KCCQ-TS and KCCQ-PL. Those with KCCQ-TS scores of 0-24 averaged 2,437.6 steps daily, and those with scores of 75-100 averaged 4,870.9 steps daily.
Similarly, participants with KCCQ-PL scores of 0-24 averaged 2301.5 steps daily, and those with scores of 75-100 averaged 5,351.9. The relationship remained significant after adjustment.
There were nonlinear relationships between activity and KCCQ scores: Daily step counts below 5,000 steps were associated with KCCQ scores, but there was little association with counts above 5,000 steps.
Compared with participants who walked 2,000 steps per day, those who walked 1,000 had KCCQ-TS scores that were 3.11 points lower; participants who walked 3,000 had KCCQ-TS scores that were 2.89 points higher.
Similarly, participants who walked 1,000 steps per day had KCCQ-PL scores that were 5.36 points lower than those who walked 2,000 steps, and those who walked 3,000 steps had KCCQ-PL scores that were 4.97 points higher.
After adjustment, change in daily step counts was significantly associated with a change in KCCQ-PL scores from baseline through 12 weeks; for example, participants whose step counts increased by 2,000 steps per day experienced a 5.33 increase in their KCCQ-PL scores relative to participants whose step counts did not change.
‘New kid on the block’
Frederick Ho, PhD, a lecturer in public health at the University of Glasgow (Scotland), who is a volunteer spokesperson for the American Heart Association, called the study “promising.”
“The study follow-up is relatively short, so it is not known whether the association is valid longer term,” he said in an interview. “It is also possible that patients with more severe symptoms became physically less active, and at the same time had worse outcomes.
“A study with longer follow-up among patients from a broader background would provide confidence on the generalizability of the findings,” said Dr. Ho, who led a recent study that showed accelerometer-measured physical activity was associated with a lower risk of heart failure. “It’d also be interesting to validate the findings using different types of wearable devices.”
Previous studies have shown that wrist-worn wearables might overestimate light-intensity activities, compared with hip-worn devices, he noted. “I’d imagine that the findings would be slightly different due to different types of devices, but the overall premise should remain.”
In a related editorial, Mitchell Psotka, MD, PhD, writes that Dr. Golbus and colleagues “have thankfully moved our understanding of actigraphy forward, although it is still the new kid on the block and will require substantial further testing and validation before widespread reliable clinical and research use.”
Terminology and reporting features need to be standardized, and preferred methods of implementation need to be established, including how to wear the devices, he suggests.
Further research is needed to validate that “accelerometers and their digitally processed movement ‘counts’ actually measure activity and that this measured activity has clinical relevance.”
The study did not receive commercial funding. Dr. Golbus, Dr. Ho, and Dr. Psotka report no relevant relationships.
A version of this article first appeared on Medscape.com.
FROM JACC: HEART FAILURE
S-ICD shows virtues, limits in ‘real-world’ postmarket study
In the latest chapter in the U.S. saga of the subcutaneous implantable cardioverter-defibrillator (S-ICD) system (Boston Scientific) – a large postmarket, multicenter registry study – the device performed at least as well as it did in earlier trials, researchers say.
The device met all prespecified safety and efficacy endpoints in a study that enrolled more than 1,600 patients and followed them for about 5 years, they noted in their report on the S-ICD Post-Approval Study (S-ICD-PAS) published online in the Journal of the American College of Cardiology.
the group reported.
The team was “pleasantly surprised” that the device’s safety and efficacy performance “was as good if not better than previous studies,” despite a sicker group of patients, lead author Michael R. Gold, MD, PhD, Medical University of South Carolina, Charleston, said in an interview.
No predictors of initial-shock failure were identified, suggesting the S-ICD should be effective in a broad range of ICD candidates without indications for pacing, Dr. Gold said.
The S-ICD was approved in Europe in 2008 and by the Food and Drug Administration in 2012. Clinical trials have suggested its performance and risk for inappropriate shocks are in line with transvenous-lead systems for most patients with ICD indications who don’t need pacing, while avoiding the sometimes serious risks posed by transvenous leads.
The S-ICD doesn’t have antitachycardia pacing (ATP), an alternative way to stop some arrhythmias and a universal feature of transvenous-lead systems. Its lack of ATP may be partly responsible for the device’s weak uptake in practice, some observers noted.
The S-ICD-PAS study “laudably included centers with variable prior experience with the S-ICD; however, data were not analyzed by center experience,” Jonathan S. Steinberg, MD, and Valentina Kutyifa, MD, PhD, University of Rochester (N.Y.) Medical Center, New York, wrote in an accompanying editorial regarding the report’s potential limitations.
Also of concern, they wrote, is the large proportion of patients who were lost to follow-up; almost 42% left the study before its prospectively defined end.
Still, wrote Dr. Steinberg and Dr. Kutyifa, S-ICD-PAS “provides robust, long-term evidence in favor of S-ICD use in a diverse cohort of younger patients receiving implants for primary or secondary prevention of sudden arrhythmic death.” Further analyses are needed, however, to clarify its performance “in centers with low vs high volume as well as in important clinical subgroups.”
It’s “reassuring to see the phase 4 postapproval study results sort of corroborate what the initial clinical study shows,” Miguel Leal, MD, Emory University, Atlanta, said in an interview.
The study’s significant attrition rate “does not negate the results because the performance curves of the device remained approximately stable over the 5 years,” he said, “suggesting that the patients who were lost [and whose clinical outcomes were not included] may not have made a significant impact when it comes to the final results.”
Although the S-ICD seems unlikely to cause complications related to endovascular occlusions or infection, “it can still cause complications related to the implant technique, particularly a device site erosion or device dislodgement,” said Dr. Leal, who chairs the American Heart Association Council on Clinical Cardiology–Electrocardiography & Arrhythmia Committee.
The S-ICD’s biggest contribution has been “the ability to promote efficacious therapy without a need for penetrating the endovascular space,” he observed. “We need to continue to push the envelope towards developing device-based technologies that spare the endovascular space.”
The study enrolled 1,643 patients at 86 U.S. centers; their mean age was 53 and 32% were women. Of the total, 1637 were implanted with the device, 665 completed the study, 288 died, and 686 left the study before completing follow-up. Of the latter, 102 (6.2% of the total) underwent S-ICD explantation, often because of infection.
In addition to the overall shock efficacy rate of 98.4%, induced-arrhythmia shock efficacy was 98.7%, first-shock efficacy for spontaneous arrhythmias was 92.2%, and the rate for either induced or spontaneous arrhythmia was 94.7%. A mean of 1.1 shocks was needed to terminate the arrhythmias; time to shock delivery averaged 17.5 seconds.
The rate of inappropriate shocks was 6.7% at 1 year and 15.8% at 5 years, notably with no significant differences between patients who had and had not undergone defibrillation threshold testing at implantation.
Of 516 inappropriate-shock episodes in 224 patients, almost 86% resulted from inappropriate sensing. Inappropriate shocks became less frequent with longer implantation times and during the course of the study.
The rate of freedom from type 1 complications, the primary safety endpoint, was 93.4%, besting the 85% performance goal. The rate of freedom from electrode-related complications was 99.3%, compared with the performance goal of 92.5%.
The S-ICD was replaced by a transvenous system because of the need for pacing in 1.6% of the cohort.
Sana M. Al-Khatib, MD, MHS, who chaired a 2017 multisociety guideline for managing ventricular arrhythmias and prevention of sudden death, acknowledged the 5-year safety and effectiveness of the S-ICD but also highlighted the “very high dropout rate.”
Moreover, given the cohort’s average age, “these results cannot be generalized to much older patients, in their 70s and 80s [for example]. More data on the S-ICD in older patients are needed, especially because some of these patients will need pacing, which is not provided by the S-ICD,” Dr. Al-Khatib, Duke University, Durham, N.C., said in an interview.
Longer follow-up of patients with the S-ICD is also needed, she added, and “having an S-ICD that is smaller with longer battery life would be great for my patients.”
The study was sponsored by Boston Scientific. Dr. Gold reported receiving consulting fees from Boston Scientific and Medtronic and participating in clinical trials with Boston Scientific, Medtronic, and Abbott. Dr. Steinberg, Dr. Kutyifa, Dr. Al-Khatib, and Dr. Leal reported no relevant relationships.
A version of this article first appeared on Medscape.com.
In the latest chapter in the U.S. saga of the subcutaneous implantable cardioverter-defibrillator (S-ICD) system (Boston Scientific) – a large postmarket, multicenter registry study – the device performed at least as well as it did in earlier trials, researchers say.
The device met all prespecified safety and efficacy endpoints in a study that enrolled more than 1,600 patients and followed them for about 5 years, they noted in their report on the S-ICD Post-Approval Study (S-ICD-PAS) published online in the Journal of the American College of Cardiology.
the group reported.
The team was “pleasantly surprised” that the device’s safety and efficacy performance “was as good if not better than previous studies,” despite a sicker group of patients, lead author Michael R. Gold, MD, PhD, Medical University of South Carolina, Charleston, said in an interview.
No predictors of initial-shock failure were identified, suggesting the S-ICD should be effective in a broad range of ICD candidates without indications for pacing, Dr. Gold said.
The S-ICD was approved in Europe in 2008 and by the Food and Drug Administration in 2012. Clinical trials have suggested its performance and risk for inappropriate shocks are in line with transvenous-lead systems for most patients with ICD indications who don’t need pacing, while avoiding the sometimes serious risks posed by transvenous leads.
The S-ICD doesn’t have antitachycardia pacing (ATP), an alternative way to stop some arrhythmias and a universal feature of transvenous-lead systems. Its lack of ATP may be partly responsible for the device’s weak uptake in practice, some observers noted.
The S-ICD-PAS study “laudably included centers with variable prior experience with the S-ICD; however, data were not analyzed by center experience,” Jonathan S. Steinberg, MD, and Valentina Kutyifa, MD, PhD, University of Rochester (N.Y.) Medical Center, New York, wrote in an accompanying editorial regarding the report’s potential limitations.
Also of concern, they wrote, is the large proportion of patients who were lost to follow-up; almost 42% left the study before its prospectively defined end.
Still, wrote Dr. Steinberg and Dr. Kutyifa, S-ICD-PAS “provides robust, long-term evidence in favor of S-ICD use in a diverse cohort of younger patients receiving implants for primary or secondary prevention of sudden arrhythmic death.” Further analyses are needed, however, to clarify its performance “in centers with low vs high volume as well as in important clinical subgroups.”
It’s “reassuring to see the phase 4 postapproval study results sort of corroborate what the initial clinical study shows,” Miguel Leal, MD, Emory University, Atlanta, said in an interview.
The study’s significant attrition rate “does not negate the results because the performance curves of the device remained approximately stable over the 5 years,” he said, “suggesting that the patients who were lost [and whose clinical outcomes were not included] may not have made a significant impact when it comes to the final results.”
Although the S-ICD seems unlikely to cause complications related to endovascular occlusions or infection, “it can still cause complications related to the implant technique, particularly a device site erosion or device dislodgement,” said Dr. Leal, who chairs the American Heart Association Council on Clinical Cardiology–Electrocardiography & Arrhythmia Committee.
The S-ICD’s biggest contribution has been “the ability to promote efficacious therapy without a need for penetrating the endovascular space,” he observed. “We need to continue to push the envelope towards developing device-based technologies that spare the endovascular space.”
The study enrolled 1,643 patients at 86 U.S. centers; their mean age was 53 and 32% were women. Of the total, 1637 were implanted with the device, 665 completed the study, 288 died, and 686 left the study before completing follow-up. Of the latter, 102 (6.2% of the total) underwent S-ICD explantation, often because of infection.
In addition to the overall shock efficacy rate of 98.4%, induced-arrhythmia shock efficacy was 98.7%, first-shock efficacy for spontaneous arrhythmias was 92.2%, and the rate for either induced or spontaneous arrhythmia was 94.7%. A mean of 1.1 shocks was needed to terminate the arrhythmias; time to shock delivery averaged 17.5 seconds.
The rate of inappropriate shocks was 6.7% at 1 year and 15.8% at 5 years, notably with no significant differences between patients who had and had not undergone defibrillation threshold testing at implantation.
Of 516 inappropriate-shock episodes in 224 patients, almost 86% resulted from inappropriate sensing. Inappropriate shocks became less frequent with longer implantation times and during the course of the study.
The rate of freedom from type 1 complications, the primary safety endpoint, was 93.4%, besting the 85% performance goal. The rate of freedom from electrode-related complications was 99.3%, compared with the performance goal of 92.5%.
The S-ICD was replaced by a transvenous system because of the need for pacing in 1.6% of the cohort.
Sana M. Al-Khatib, MD, MHS, who chaired a 2017 multisociety guideline for managing ventricular arrhythmias and prevention of sudden death, acknowledged the 5-year safety and effectiveness of the S-ICD but also highlighted the “very high dropout rate.”
Moreover, given the cohort’s average age, “these results cannot be generalized to much older patients, in their 70s and 80s [for example]. More data on the S-ICD in older patients are needed, especially because some of these patients will need pacing, which is not provided by the S-ICD,” Dr. Al-Khatib, Duke University, Durham, N.C., said in an interview.
Longer follow-up of patients with the S-ICD is also needed, she added, and “having an S-ICD that is smaller with longer battery life would be great for my patients.”
The study was sponsored by Boston Scientific. Dr. Gold reported receiving consulting fees from Boston Scientific and Medtronic and participating in clinical trials with Boston Scientific, Medtronic, and Abbott. Dr. Steinberg, Dr. Kutyifa, Dr. Al-Khatib, and Dr. Leal reported no relevant relationships.
A version of this article first appeared on Medscape.com.
In the latest chapter in the U.S. saga of the subcutaneous implantable cardioverter-defibrillator (S-ICD) system (Boston Scientific) – a large postmarket, multicenter registry study – the device performed at least as well as it did in earlier trials, researchers say.
The device met all prespecified safety and efficacy endpoints in a study that enrolled more than 1,600 patients and followed them for about 5 years, they noted in their report on the S-ICD Post-Approval Study (S-ICD-PAS) published online in the Journal of the American College of Cardiology.
the group reported.
The team was “pleasantly surprised” that the device’s safety and efficacy performance “was as good if not better than previous studies,” despite a sicker group of patients, lead author Michael R. Gold, MD, PhD, Medical University of South Carolina, Charleston, said in an interview.
No predictors of initial-shock failure were identified, suggesting the S-ICD should be effective in a broad range of ICD candidates without indications for pacing, Dr. Gold said.
The S-ICD was approved in Europe in 2008 and by the Food and Drug Administration in 2012. Clinical trials have suggested its performance and risk for inappropriate shocks are in line with transvenous-lead systems for most patients with ICD indications who don’t need pacing, while avoiding the sometimes serious risks posed by transvenous leads.
The S-ICD doesn’t have antitachycardia pacing (ATP), an alternative way to stop some arrhythmias and a universal feature of transvenous-lead systems. Its lack of ATP may be partly responsible for the device’s weak uptake in practice, some observers noted.
The S-ICD-PAS study “laudably included centers with variable prior experience with the S-ICD; however, data were not analyzed by center experience,” Jonathan S. Steinberg, MD, and Valentina Kutyifa, MD, PhD, University of Rochester (N.Y.) Medical Center, New York, wrote in an accompanying editorial regarding the report’s potential limitations.
Also of concern, they wrote, is the large proportion of patients who were lost to follow-up; almost 42% left the study before its prospectively defined end.
Still, wrote Dr. Steinberg and Dr. Kutyifa, S-ICD-PAS “provides robust, long-term evidence in favor of S-ICD use in a diverse cohort of younger patients receiving implants for primary or secondary prevention of sudden arrhythmic death.” Further analyses are needed, however, to clarify its performance “in centers with low vs high volume as well as in important clinical subgroups.”
It’s “reassuring to see the phase 4 postapproval study results sort of corroborate what the initial clinical study shows,” Miguel Leal, MD, Emory University, Atlanta, said in an interview.
The study’s significant attrition rate “does not negate the results because the performance curves of the device remained approximately stable over the 5 years,” he said, “suggesting that the patients who were lost [and whose clinical outcomes were not included] may not have made a significant impact when it comes to the final results.”
Although the S-ICD seems unlikely to cause complications related to endovascular occlusions or infection, “it can still cause complications related to the implant technique, particularly a device site erosion or device dislodgement,” said Dr. Leal, who chairs the American Heart Association Council on Clinical Cardiology–Electrocardiography & Arrhythmia Committee.
The S-ICD’s biggest contribution has been “the ability to promote efficacious therapy without a need for penetrating the endovascular space,” he observed. “We need to continue to push the envelope towards developing device-based technologies that spare the endovascular space.”
The study enrolled 1,643 patients at 86 U.S. centers; their mean age was 53 and 32% were women. Of the total, 1637 were implanted with the device, 665 completed the study, 288 died, and 686 left the study before completing follow-up. Of the latter, 102 (6.2% of the total) underwent S-ICD explantation, often because of infection.
In addition to the overall shock efficacy rate of 98.4%, induced-arrhythmia shock efficacy was 98.7%, first-shock efficacy for spontaneous arrhythmias was 92.2%, and the rate for either induced or spontaneous arrhythmia was 94.7%. A mean of 1.1 shocks was needed to terminate the arrhythmias; time to shock delivery averaged 17.5 seconds.
The rate of inappropriate shocks was 6.7% at 1 year and 15.8% at 5 years, notably with no significant differences between patients who had and had not undergone defibrillation threshold testing at implantation.
Of 516 inappropriate-shock episodes in 224 patients, almost 86% resulted from inappropriate sensing. Inappropriate shocks became less frequent with longer implantation times and during the course of the study.
The rate of freedom from type 1 complications, the primary safety endpoint, was 93.4%, besting the 85% performance goal. The rate of freedom from electrode-related complications was 99.3%, compared with the performance goal of 92.5%.
The S-ICD was replaced by a transvenous system because of the need for pacing in 1.6% of the cohort.
Sana M. Al-Khatib, MD, MHS, who chaired a 2017 multisociety guideline for managing ventricular arrhythmias and prevention of sudden death, acknowledged the 5-year safety and effectiveness of the S-ICD but also highlighted the “very high dropout rate.”
Moreover, given the cohort’s average age, “these results cannot be generalized to much older patients, in their 70s and 80s [for example]. More data on the S-ICD in older patients are needed, especially because some of these patients will need pacing, which is not provided by the S-ICD,” Dr. Al-Khatib, Duke University, Durham, N.C., said in an interview.
Longer follow-up of patients with the S-ICD is also needed, she added, and “having an S-ICD that is smaller with longer battery life would be great for my patients.”
The study was sponsored by Boston Scientific. Dr. Gold reported receiving consulting fees from Boston Scientific and Medtronic and participating in clinical trials with Boston Scientific, Medtronic, and Abbott. Dr. Steinberg, Dr. Kutyifa, Dr. Al-Khatib, and Dr. Leal reported no relevant relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Mixed bag: New performance data on femoral-popliteal artery revascularization
Measured one way, success for peripheral vascular intervention (PVI) in the femoropopliteal arteries for patients with intermittent claudication has improved, as the need for repeat PVI appears to be very low, and lower than in recent years, a new analysis suggests. But measured another way, the researchers said, PVI’s record of success in peripheral arterial disease (PAD) remains marred by a substantial risk for amputation involving the treated limb.
In their analysis, The rate for popliteal interventions was significantly higher than for PVI limited to the superficial femoral artery (SFA), 7.5% and 3.4%, respectively.
The 4-year rate of repeat target-vessel revascularization, however, was “lower than expected” at 15.2% in the analysis, which was based on the PINC AI Healthcare Data database covering over 1,100 U.S. hospitals. The study was published online in JACC: Cardiovascular Interventions.
The amputation rates for index treated limbs “surprised us,” lead author S. Elissa Altin, MD, Yale University, New Haven, Conn., said in an interview. The increased rate after procedures limited to the popliteal artery, compared with the SFA, “were even more concerning,” she said. “This is higher than accepted natural history rates of amputation in patients with conservatively managed claudication.”
Of particular concern in the study, agreed the author of an accompanying editorial, “is the finding of a 1 in 25 risk for amputation among patients with [intermittent claudication] undergoing revascularization, which underscores that both patients and physicians must ensure that evidence-based lifestyle and medical therapies are exhausted prior to pursuing [femoropopliteal] revascularization.”
Given such amputation concerns “and the availability of effective lifestyle and medical therapies,” wrote Debabrata Mukherjee, MD, Texas Tech University Health Sciences Center, El Paso, “PVI should be restricted in stable PAD only for those with persistent lifestyle-limiting claudication despite [guideline-directed medical therapy] and structured exercise therapy.”
Dr. Altin and colleagues analyzed data from 19,324 patients with intermittent claudication (mean age, 69 years; 59% men) who underwent femoropopliteal PVI from 2016 to 2020.
Use of atherectomy and of drug-eluting balloons were both similarly prevalent for popliteal and SFA target arteries; however, SFA lesions were more commonly treated with stents.
The rate of amputation in the treated limb over 4 years was 4.3%; the rate of major (above the ankle) amputation was 3.2%.
The multivariable-adjusted treated-limb amputation hazard ratio for popliteal versus SFA procedures was for 2.10 (95% confidence interval, 1.52-2.92) for any amputation and 1.98 (95% CI, 1.32-2.95) for major amputation.
The 4-year rate of index-limb repeat revascularization was 16.7% overall, 20.1% for patients with an index procedure in both the popliteal and SFA segments, 19% after popliteal-only procedures, and 15.4% after SFA-only procedures (P < .0001), the report stated.
The overall lower-than-expected revascularization rates, the authors proposed, may reflect improvements in endovascular therapies for femoropopliteal lesions, such as drug-eluting stents and advances in medical therapy.
“Additionally, this may underscore a difference between trial-defined target-lesion revascularization compared with clinically driven target-lesion revascularization in practice,” they wrote.
The study’s revascularization rates could have been underestimated because “some of the patients in this study may have had procedures conducted in other hospital systems or at an office-based lab during the study period,” proposed interventional cardiologist Seyi Bolorunduro MD, MPH, INOVA Heart and Vascular Institute, Falls Church, Va.
“This and other studies highlight the need to be cautious about offering PVI to patients with intermittent claudication,” said Dr. Bolorunduro, who was not connected with the current study. On the other hand, he added, randomized trial data show “that combination therapy with PVI followed by supervised exercise results in greater improvement in walking distances and quality-of-life scores, compared with supervised exercise alone, at 1 year.’
Femoropopliteal PVI “is an important tool for patients with residual, truly lifestyle-limiting claudication after exhausting medical therapies, complete smoking cessation, and structured exercise programs,” Dr. Altin said. Future studies, she added, should look prospectively at patients with claudication who underwent early versus delayed invasive management.
In his editorial, Dr. Mukherjee said that, for patients with PAD and claudication, a proprotein convertase subtilisin/kexin type 9 inhibitor may be recommended if LDL cholesterol remains 70 mg/dL or higher and symptoms persist after a regimen of lifestyle modification, exercise, antiplatelet therapy, and high-intensity statins and other guideline-directed medical therapy. He also suggests a direct oral anticoagulant be considered before resorting to endovascular or surgical revascularization.
“We need to optimize risk-factor modification, medical therapy and exercise, and only reserve PVI for patients with severe lifestyle-limiting intermittent claudication who have tried and failed everything else,” Dr. Bolorunduro agreed in an interview. “I educate my patients about [the amputation] risk and let them know that PVI is not a panacea.”
Dr. Altin has disclosed no relevant relationships. Dr. Mukherjee and Dr. Bolorunduro have no relevant disclosures.
A version of this article first appeared on Medscape.com.
Measured one way, success for peripheral vascular intervention (PVI) in the femoropopliteal arteries for patients with intermittent claudication has improved, as the need for repeat PVI appears to be very low, and lower than in recent years, a new analysis suggests. But measured another way, the researchers said, PVI’s record of success in peripheral arterial disease (PAD) remains marred by a substantial risk for amputation involving the treated limb.
In their analysis, The rate for popliteal interventions was significantly higher than for PVI limited to the superficial femoral artery (SFA), 7.5% and 3.4%, respectively.
The 4-year rate of repeat target-vessel revascularization, however, was “lower than expected” at 15.2% in the analysis, which was based on the PINC AI Healthcare Data database covering over 1,100 U.S. hospitals. The study was published online in JACC: Cardiovascular Interventions.
The amputation rates for index treated limbs “surprised us,” lead author S. Elissa Altin, MD, Yale University, New Haven, Conn., said in an interview. The increased rate after procedures limited to the popliteal artery, compared with the SFA, “were even more concerning,” she said. “This is higher than accepted natural history rates of amputation in patients with conservatively managed claudication.”
Of particular concern in the study, agreed the author of an accompanying editorial, “is the finding of a 1 in 25 risk for amputation among patients with [intermittent claudication] undergoing revascularization, which underscores that both patients and physicians must ensure that evidence-based lifestyle and medical therapies are exhausted prior to pursuing [femoropopliteal] revascularization.”
Given such amputation concerns “and the availability of effective lifestyle and medical therapies,” wrote Debabrata Mukherjee, MD, Texas Tech University Health Sciences Center, El Paso, “PVI should be restricted in stable PAD only for those with persistent lifestyle-limiting claudication despite [guideline-directed medical therapy] and structured exercise therapy.”
Dr. Altin and colleagues analyzed data from 19,324 patients with intermittent claudication (mean age, 69 years; 59% men) who underwent femoropopliteal PVI from 2016 to 2020.
Use of atherectomy and of drug-eluting balloons were both similarly prevalent for popliteal and SFA target arteries; however, SFA lesions were more commonly treated with stents.
The rate of amputation in the treated limb over 4 years was 4.3%; the rate of major (above the ankle) amputation was 3.2%.
The multivariable-adjusted treated-limb amputation hazard ratio for popliteal versus SFA procedures was for 2.10 (95% confidence interval, 1.52-2.92) for any amputation and 1.98 (95% CI, 1.32-2.95) for major amputation.
The 4-year rate of index-limb repeat revascularization was 16.7% overall, 20.1% for patients with an index procedure in both the popliteal and SFA segments, 19% after popliteal-only procedures, and 15.4% after SFA-only procedures (P < .0001), the report stated.
The overall lower-than-expected revascularization rates, the authors proposed, may reflect improvements in endovascular therapies for femoropopliteal lesions, such as drug-eluting stents and advances in medical therapy.
“Additionally, this may underscore a difference between trial-defined target-lesion revascularization compared with clinically driven target-lesion revascularization in practice,” they wrote.
The study’s revascularization rates could have been underestimated because “some of the patients in this study may have had procedures conducted in other hospital systems or at an office-based lab during the study period,” proposed interventional cardiologist Seyi Bolorunduro MD, MPH, INOVA Heart and Vascular Institute, Falls Church, Va.
“This and other studies highlight the need to be cautious about offering PVI to patients with intermittent claudication,” said Dr. Bolorunduro, who was not connected with the current study. On the other hand, he added, randomized trial data show “that combination therapy with PVI followed by supervised exercise results in greater improvement in walking distances and quality-of-life scores, compared with supervised exercise alone, at 1 year.’
Femoropopliteal PVI “is an important tool for patients with residual, truly lifestyle-limiting claudication after exhausting medical therapies, complete smoking cessation, and structured exercise programs,” Dr. Altin said. Future studies, she added, should look prospectively at patients with claudication who underwent early versus delayed invasive management.
In his editorial, Dr. Mukherjee said that, for patients with PAD and claudication, a proprotein convertase subtilisin/kexin type 9 inhibitor may be recommended if LDL cholesterol remains 70 mg/dL or higher and symptoms persist after a regimen of lifestyle modification, exercise, antiplatelet therapy, and high-intensity statins and other guideline-directed medical therapy. He also suggests a direct oral anticoagulant be considered before resorting to endovascular or surgical revascularization.
“We need to optimize risk-factor modification, medical therapy and exercise, and only reserve PVI for patients with severe lifestyle-limiting intermittent claudication who have tried and failed everything else,” Dr. Bolorunduro agreed in an interview. “I educate my patients about [the amputation] risk and let them know that PVI is not a panacea.”
Dr. Altin has disclosed no relevant relationships. Dr. Mukherjee and Dr. Bolorunduro have no relevant disclosures.
A version of this article first appeared on Medscape.com.
Measured one way, success for peripheral vascular intervention (PVI) in the femoropopliteal arteries for patients with intermittent claudication has improved, as the need for repeat PVI appears to be very low, and lower than in recent years, a new analysis suggests. But measured another way, the researchers said, PVI’s record of success in peripheral arterial disease (PAD) remains marred by a substantial risk for amputation involving the treated limb.
In their analysis, The rate for popliteal interventions was significantly higher than for PVI limited to the superficial femoral artery (SFA), 7.5% and 3.4%, respectively.
The 4-year rate of repeat target-vessel revascularization, however, was “lower than expected” at 15.2% in the analysis, which was based on the PINC AI Healthcare Data database covering over 1,100 U.S. hospitals. The study was published online in JACC: Cardiovascular Interventions.
The amputation rates for index treated limbs “surprised us,” lead author S. Elissa Altin, MD, Yale University, New Haven, Conn., said in an interview. The increased rate after procedures limited to the popliteal artery, compared with the SFA, “were even more concerning,” she said. “This is higher than accepted natural history rates of amputation in patients with conservatively managed claudication.”
Of particular concern in the study, agreed the author of an accompanying editorial, “is the finding of a 1 in 25 risk for amputation among patients with [intermittent claudication] undergoing revascularization, which underscores that both patients and physicians must ensure that evidence-based lifestyle and medical therapies are exhausted prior to pursuing [femoropopliteal] revascularization.”
Given such amputation concerns “and the availability of effective lifestyle and medical therapies,” wrote Debabrata Mukherjee, MD, Texas Tech University Health Sciences Center, El Paso, “PVI should be restricted in stable PAD only for those with persistent lifestyle-limiting claudication despite [guideline-directed medical therapy] and structured exercise therapy.”
Dr. Altin and colleagues analyzed data from 19,324 patients with intermittent claudication (mean age, 69 years; 59% men) who underwent femoropopliteal PVI from 2016 to 2020.
Use of atherectomy and of drug-eluting balloons were both similarly prevalent for popliteal and SFA target arteries; however, SFA lesions were more commonly treated with stents.
The rate of amputation in the treated limb over 4 years was 4.3%; the rate of major (above the ankle) amputation was 3.2%.
The multivariable-adjusted treated-limb amputation hazard ratio for popliteal versus SFA procedures was for 2.10 (95% confidence interval, 1.52-2.92) for any amputation and 1.98 (95% CI, 1.32-2.95) for major amputation.
The 4-year rate of index-limb repeat revascularization was 16.7% overall, 20.1% for patients with an index procedure in both the popliteal and SFA segments, 19% after popliteal-only procedures, and 15.4% after SFA-only procedures (P < .0001), the report stated.
The overall lower-than-expected revascularization rates, the authors proposed, may reflect improvements in endovascular therapies for femoropopliteal lesions, such as drug-eluting stents and advances in medical therapy.
“Additionally, this may underscore a difference between trial-defined target-lesion revascularization compared with clinically driven target-lesion revascularization in practice,” they wrote.
The study’s revascularization rates could have been underestimated because “some of the patients in this study may have had procedures conducted in other hospital systems or at an office-based lab during the study period,” proposed interventional cardiologist Seyi Bolorunduro MD, MPH, INOVA Heart and Vascular Institute, Falls Church, Va.
“This and other studies highlight the need to be cautious about offering PVI to patients with intermittent claudication,” said Dr. Bolorunduro, who was not connected with the current study. On the other hand, he added, randomized trial data show “that combination therapy with PVI followed by supervised exercise results in greater improvement in walking distances and quality-of-life scores, compared with supervised exercise alone, at 1 year.’
Femoropopliteal PVI “is an important tool for patients with residual, truly lifestyle-limiting claudication after exhausting medical therapies, complete smoking cessation, and structured exercise programs,” Dr. Altin said. Future studies, she added, should look prospectively at patients with claudication who underwent early versus delayed invasive management.
In his editorial, Dr. Mukherjee said that, for patients with PAD and claudication, a proprotein convertase subtilisin/kexin type 9 inhibitor may be recommended if LDL cholesterol remains 70 mg/dL or higher and symptoms persist after a regimen of lifestyle modification, exercise, antiplatelet therapy, and high-intensity statins and other guideline-directed medical therapy. He also suggests a direct oral anticoagulant be considered before resorting to endovascular or surgical revascularization.
“We need to optimize risk-factor modification, medical therapy and exercise, and only reserve PVI for patients with severe lifestyle-limiting intermittent claudication who have tried and failed everything else,” Dr. Bolorunduro agreed in an interview. “I educate my patients about [the amputation] risk and let them know that PVI is not a panacea.”
Dr. Altin has disclosed no relevant relationships. Dr. Mukherjee and Dr. Bolorunduro have no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM JACC: CARDIOVASCULAR INTERVENTIONS