Key clinical point: Natalizumab is effective on the inflammatory phase of relapsing-remitting multiple sclerosis (RRMS). The frequency of poor outcomes is low and are predicted by disease activity criteria.

Major finding: At 10 years, the cumulative probabilities for secondary progressive multiple sclerosis (SPMS) conversion, Expanded Disability Status Scale (EDSS) worsening, reaching EDSS-4 and EDSS-6 were 23.7%, 30.4%, 25.1%, and 12.4%, respectively with natalizumab. The mean reduction in annualized relapsed rate at 10 years was 97.5% (P less than .0001). Factors predictive of disability at the long-term were not reaching ‘no evidence of disease activity’ (NEDA)-3, MRI worsening, increased EDSS score, and to a lesser extent the occurrence of relapse.

Study details: TYSTEN was a real-life observational study that assessed 770 patients with RRMS starting Natalizumab between 2007 and 2012. The mean follow-up duration was 97.2 months and mean treatment duration for natalizumab was 66 months.

Disclosures: The study received no funding. The presenting author had no disclosures. Some of his coinvestigators reported ties with Biogen Idec.

Citation: Bigaut K et al. Mult Scler. 2020 Jul 9. doi: 10.1177/1352458520936239.

Key clinical point: Natalizumab is effective on the inflammatory phase of relapsing-remitting multiple sclerosis (RRMS). The frequency of poor outcomes is low and are predicted by disease activity criteria.

Major finding: At 10 years, the cumulative probabilities for secondary progressive multiple sclerosis (SPMS) conversion, Expanded Disability Status Scale (EDSS) worsening, reaching EDSS-4 and EDSS-6 were 23.7%, 30.4%, 25.1%, and 12.4%, respectively with natalizumab. The mean reduction in annualized relapsed rate at 10 years was 97.5% (P less than .0001). Factors predictive of disability at the long-term were not reaching ‘no evidence of disease activity’ (NEDA)-3, MRI worsening, increased EDSS score, and to a lesser extent the occurrence of relapse.

Study details: TYSTEN was a real-life observational study that assessed 770 patients with RRMS starting Natalizumab between 2007 and 2012. The mean follow-up duration was 97.2 months and mean treatment duration for natalizumab was 66 months.

Disclosures: The study received no funding. The presenting author had no disclosures. Some of his coinvestigators reported ties with Biogen Idec.

Citation: Bigaut K et al. Mult Scler. 2020 Jul 9. doi: 10.1177/1352458520936239.

Key clinical point: Natalizumab is effective on the inflammatory phase of relapsing-remitting multiple sclerosis (RRMS). The frequency of poor outcomes is low and are predicted by disease activity criteria.

Major finding: At 10 years, the cumulative probabilities for secondary progressive multiple sclerosis (SPMS) conversion, Expanded Disability Status Scale (EDSS) worsening, reaching EDSS-4 and EDSS-6 were 23.7%, 30.4%, 25.1%, and 12.4%, respectively with natalizumab. The mean reduction in annualized relapsed rate at 10 years was 97.5% (P less than .0001). Factors predictive of disability at the long-term were not reaching ‘no evidence of disease activity’ (NEDA)-3, MRI worsening, increased EDSS score, and to a lesser extent the occurrence of relapse.

Study details: TYSTEN was a real-life observational study that assessed 770 patients with RRMS starting Natalizumab between 2007 and 2012. The mean follow-up duration was 97.2 months and mean treatment duration for natalizumab was 66 months.

Disclosures: The study received no funding. The presenting author had no disclosures. Some of his coinvestigators reported ties with Biogen Idec.

Citation: Bigaut K et al. Mult Scler. 2020 Jul 9. doi: 10.1177/1352458520936239.

Key clinical point: Stressful life events are associated with an increased risk of developing multiple sclerosis (MS).

Major finding: Stressful major life events that happened prior to disease onset significantly increased the risk by 17%-30%. Women were more vulnerable than men under certain stressful scenarios such as conflict at work or within families, marriage, sickness, or accident of family members.

Study details: A large Swedish case-control study of 2,930 patients with MS and 6,170 control participants.

Disclosures: Dr. Jiang was supported by a starting package from the Swedish Research Council.

Citation: Jiang X et al. Eur J Neurol. 2020 Aug 2. doi: 10.1111/ene.14458.

Key clinical point: Stressful life events are associated with an increased risk of developing multiple sclerosis (MS).

Major finding: Stressful major life events that happened prior to disease onset significantly increased the risk by 17%-30%. Women were more vulnerable than men under certain stressful scenarios such as conflict at work or within families, marriage, sickness, or accident of family members.

Study details: A large Swedish case-control study of 2,930 patients with MS and 6,170 control participants.

Disclosures: Dr. Jiang was supported by a starting package from the Swedish Research Council.

Citation: Jiang X et al. Eur J Neurol. 2020 Aug 2. doi: 10.1111/ene.14458.

Key clinical point: Stressful life events are associated with an increased risk of developing multiple sclerosis (MS).

Major finding: Stressful major life events that happened prior to disease onset significantly increased the risk by 17%-30%. Women were more vulnerable than men under certain stressful scenarios such as conflict at work or within families, marriage, sickness, or accident of family members.

Study details: A large Swedish case-control study of 2,930 patients with MS and 6,170 control participants.

Disclosures: Dr. Jiang was supported by a starting package from the Swedish Research Council.

Citation: Jiang X et al. Eur J Neurol. 2020 Aug 2. doi: 10.1111/ene.14458.

A Pesco-Mediterranean diet consisting of plants, legumes, nuts, whole grains, extra-virgin olive oil (EVOO), moderate amounts of dairy products, and fish and/or seafood, together with intermittent fasting (also called time-restricted eating), can reduce risk for cardiovascular disease (CVD), according to a new review.

The authors presented the research and conceptual underpinnings of this approach, which “proposes that following a Pesco-Mediterranean diet with time-restricted eating is evidence-based and ideal for reducing cardiovascular risk,” study coauthor Sarah Smith, PhD, RN, of Saint Luke’s Mid America Heart Institute, Kansas City, Mo., said in an interview.

The review was published online September 14 in the Journal of the American College of Cardiology.
 

‘Omnivore’s dilemma’

A host of epidemiologic studies and randomized clinical trials support an association between the traditional Mediterranean diet and lower risk for all-cause and CVD mortality, coronary heart disease, metabolic syndrome, neurodegenerative diseases, and other adverse outcome. The diet has been subsequently endorsed by several sets of guidelines, including those from the Department of Health & Human Services and the Department of Agriculture, and the 2019 American Heart Association/American College of Cardiology primary prevention guidelines.

“Although humans are omnivores and can subsist on a myriad of foods, the ideal diet for health remains a dilemma for many people,” lead author James H. O’Keefe, MD, director of preventive cardiology at Saint Luke’s, said in a news release.

“Plant-rich diets reduce CVD risk; however, veganism is difficult to follow and can result in important nutrient deficiencies,” he stated.

On the other hand, “the standard American diet is high in red meat, especially processed meat from animals raised in inhumane conditions, fed unnatural foods, and often treated with hormones and antibiotics,” the authors pointed out.

Together with overconsumption of red meat, sugar and processed food contribute to poor health outcomes, Dr. Smith noted.

The review was designed to present the Pesco-Mediterranean diet as “a solution to the ‘omnivore’s dilemma’ about what to eat,” said Dr. O’Keefe.

Study coauthor Ibrahim M. Saeed, MD, a cardiologist at Saint Luke’s, added that the research “attempts to emphasize the results of landmark prospective trials that highlight good, healthy eating options rather than just [foods that people would] want to avoid.”
 

Key components

The traditional Mediterranean diet includes “unrestricted use of EVOO,” but the quality of the olive oil is “crucial” and it must be unrefined and cold pressed, the authors emphasized.

The “highly bioactive” polyphenols likely “underlie EVOO’s numerous cardiometabolic benefits,” the researchers wrote, noting that the 2014 PREDIMED trial provided “first-level scientific evidence of [EVOO’s] cardioprotective effects [if used] within the context of the Mediterranean diet.”

The authors recommend “generous use” of EVOO in salad dressings and vegetable dishes, pasta, rice, fish, sauces, or legumes.

They also review the role of tree nuts, noting that they are “nutrient-dense foods rich in unsaturated fats, fiber, protein, polyphenols, phytosterols, tocopherols, and nonsodium minerals” and have been shown beneficial in CVD prevention.

Legumes play a “central role” in the Mediterranean diet and are an “excellent source” of vegetable protein, folate, magnesium, and fiber. Legume consumption is associated with lowered risk for CVD, as well as improved blood glucose, cholesterol, blood pressure, and body weight, the authors stated.

Whole grains like barley, whole oats, brown rice, and quinoa are likewise central components of the traditional Mediterranean diet. The authors warned that refined grain products and commercial precooked pasta or pizza should be “consumed only in small amounts.”
 

Window of time

In time-restricted eating (which is one type of intermittent fasting), the daily intake of food is limited to a window of time, usually 6-12 hours each day, the authors explained.

When done regularly, this type of eating has been shown to both decrease intra-abdominal adipose tissue and reduce free-radical production. Additionally, it “elicits powerful cellular responses” that may reduce risks for systemic inflammation, diabetes, CVD, cancer, and neurodegenerative diseases.

However, the authors warned, the evidence supporting time-restricted eating is still preliminary.
 

‘Let food be thy medicine’

Andrew Freeman, MD, cochair of the ACC’s nutrition & lifestyle work group, cautioned that many American plant-based Mediterranean diets often include large amount of feta cheese and lamb and foods are often “heavily doused” in olive oil, while the traditional Mediterranean diet consists primarily of greens and lentils and is plant based.

“The goal would be to have a whole grain and leafy vegetables as the center of the meal, and – if an animal product such as fish is included – it should be limited to as little as possible and used as the garnish rather than the main dish,” he stated.

Moreover, fish are often exposed to large amount of toxins, heavy metals, and microplastics, so “don’t overdo eating fish,” he advised.

Dr. Freeman said that intermittent fasting “has a lot of promise and no harm” and concentrating food consumption during a shorter period in the day instead of “grazing throughout the day” will reduce constant snacking. “But don’t gorge yourself during those hours,” he warned.

Dr. Freeman concluded by citing the guidance of Hippocrates: “Let food be thy medicine.

“There’s some real truth to that,” he added.

No source of funding was listed. Dr. Smith and Dr. Freeman disclosed no relevant financial relationships. Dr. O’Keefe has a major ownership interest in CardioTabs, a supplement company that sells some products containing omega-3 fatty acids.

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

A Pesco-Mediterranean diet consisting of plants, legumes, nuts, whole grains, extra-virgin olive oil (EVOO), moderate amounts of dairy products, and fish and/or seafood, together with intermittent fasting (also called time-restricted eating), can reduce risk for cardiovascular disease (CVD), according to a new review.

The authors presented the research and conceptual underpinnings of this approach, which “proposes that following a Pesco-Mediterranean diet with time-restricted eating is evidence-based and ideal for reducing cardiovascular risk,” study coauthor Sarah Smith, PhD, RN, of Saint Luke’s Mid America Heart Institute, Kansas City, Mo., said in an interview.

The review was published online September 14 in the Journal of the American College of Cardiology.
 

‘Omnivore’s dilemma’

A host of epidemiologic studies and randomized clinical trials support an association between the traditional Mediterranean diet and lower risk for all-cause and CVD mortality, coronary heart disease, metabolic syndrome, neurodegenerative diseases, and other adverse outcome. The diet has been subsequently endorsed by several sets of guidelines, including those from the Department of Health & Human Services and the Department of Agriculture, and the 2019 American Heart Association/American College of Cardiology primary prevention guidelines.

“Although humans are omnivores and can subsist on a myriad of foods, the ideal diet for health remains a dilemma for many people,” lead author James H. O’Keefe, MD, director of preventive cardiology at Saint Luke’s, said in a news release.

“Plant-rich diets reduce CVD risk; however, veganism is difficult to follow and can result in important nutrient deficiencies,” he stated.

On the other hand, “the standard American diet is high in red meat, especially processed meat from animals raised in inhumane conditions, fed unnatural foods, and often treated with hormones and antibiotics,” the authors pointed out.

Together with overconsumption of red meat, sugar and processed food contribute to poor health outcomes, Dr. Smith noted.

The review was designed to present the Pesco-Mediterranean diet as “a solution to the ‘omnivore’s dilemma’ about what to eat,” said Dr. O’Keefe.

Study coauthor Ibrahim M. Saeed, MD, a cardiologist at Saint Luke’s, added that the research “attempts to emphasize the results of landmark prospective trials that highlight good, healthy eating options rather than just [foods that people would] want to avoid.”
 

Key components

The traditional Mediterranean diet includes “unrestricted use of EVOO,” but the quality of the olive oil is “crucial” and it must be unrefined and cold pressed, the authors emphasized.

The “highly bioactive” polyphenols likely “underlie EVOO’s numerous cardiometabolic benefits,” the researchers wrote, noting that the 2014 PREDIMED trial provided “first-level scientific evidence of [EVOO’s] cardioprotective effects [if used] within the context of the Mediterranean diet.”

The authors recommend “generous use” of EVOO in salad dressings and vegetable dishes, pasta, rice, fish, sauces, or legumes.

They also review the role of tree nuts, noting that they are “nutrient-dense foods rich in unsaturated fats, fiber, protein, polyphenols, phytosterols, tocopherols, and nonsodium minerals” and have been shown beneficial in CVD prevention.

Legumes play a “central role” in the Mediterranean diet and are an “excellent source” of vegetable protein, folate, magnesium, and fiber. Legume consumption is associated with lowered risk for CVD, as well as improved blood glucose, cholesterol, blood pressure, and body weight, the authors stated.

Whole grains like barley, whole oats, brown rice, and quinoa are likewise central components of the traditional Mediterranean diet. The authors warned that refined grain products and commercial precooked pasta or pizza should be “consumed only in small amounts.”
 

Window of time

In time-restricted eating (which is one type of intermittent fasting), the daily intake of food is limited to a window of time, usually 6-12 hours each day, the authors explained.

When done regularly, this type of eating has been shown to both decrease intra-abdominal adipose tissue and reduce free-radical production. Additionally, it “elicits powerful cellular responses” that may reduce risks for systemic inflammation, diabetes, CVD, cancer, and neurodegenerative diseases.

However, the authors warned, the evidence supporting time-restricted eating is still preliminary.
 

‘Let food be thy medicine’

Andrew Freeman, MD, cochair of the ACC’s nutrition & lifestyle work group, cautioned that many American plant-based Mediterranean diets often include large amount of feta cheese and lamb and foods are often “heavily doused” in olive oil, while the traditional Mediterranean diet consists primarily of greens and lentils and is plant based.

“The goal would be to have a whole grain and leafy vegetables as the center of the meal, and – if an animal product such as fish is included – it should be limited to as little as possible and used as the garnish rather than the main dish,” he stated.

Moreover, fish are often exposed to large amount of toxins, heavy metals, and microplastics, so “don’t overdo eating fish,” he advised.

Dr. Freeman said that intermittent fasting “has a lot of promise and no harm” and concentrating food consumption during a shorter period in the day instead of “grazing throughout the day” will reduce constant snacking. “But don’t gorge yourself during those hours,” he warned.

Dr. Freeman concluded by citing the guidance of Hippocrates: “Let food be thy medicine.

“There’s some real truth to that,” he added.

No source of funding was listed. Dr. Smith and Dr. Freeman disclosed no relevant financial relationships. Dr. O’Keefe has a major ownership interest in CardioTabs, a supplement company that sells some products containing omega-3 fatty acids.

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

A Pesco-Mediterranean diet consisting of plants, legumes, nuts, whole grains, extra-virgin olive oil (EVOO), moderate amounts of dairy products, and fish and/or seafood, together with intermittent fasting (also called time-restricted eating), can reduce risk for cardiovascular disease (CVD), according to a new review.

The authors presented the research and conceptual underpinnings of this approach, which “proposes that following a Pesco-Mediterranean diet with time-restricted eating is evidence-based and ideal for reducing cardiovascular risk,” study coauthor Sarah Smith, PhD, RN, of Saint Luke’s Mid America Heart Institute, Kansas City, Mo., said in an interview.

The review was published online September 14 in the Journal of the American College of Cardiology.
 

‘Omnivore’s dilemma’

A host of epidemiologic studies and randomized clinical trials support an association between the traditional Mediterranean diet and lower risk for all-cause and CVD mortality, coronary heart disease, metabolic syndrome, neurodegenerative diseases, and other adverse outcome. The diet has been subsequently endorsed by several sets of guidelines, including those from the Department of Health & Human Services and the Department of Agriculture, and the 2019 American Heart Association/American College of Cardiology primary prevention guidelines.

“Although humans are omnivores and can subsist on a myriad of foods, the ideal diet for health remains a dilemma for many people,” lead author James H. O’Keefe, MD, director of preventive cardiology at Saint Luke’s, said in a news release.

“Plant-rich diets reduce CVD risk; however, veganism is difficult to follow and can result in important nutrient deficiencies,” he stated.

On the other hand, “the standard American diet is high in red meat, especially processed meat from animals raised in inhumane conditions, fed unnatural foods, and often treated with hormones and antibiotics,” the authors pointed out.

Together with overconsumption of red meat, sugar and processed food contribute to poor health outcomes, Dr. Smith noted.

The review was designed to present the Pesco-Mediterranean diet as “a solution to the ‘omnivore’s dilemma’ about what to eat,” said Dr. O’Keefe.

Study coauthor Ibrahim M. Saeed, MD, a cardiologist at Saint Luke’s, added that the research “attempts to emphasize the results of landmark prospective trials that highlight good, healthy eating options rather than just [foods that people would] want to avoid.”
 

Key components

The traditional Mediterranean diet includes “unrestricted use of EVOO,” but the quality of the olive oil is “crucial” and it must be unrefined and cold pressed, the authors emphasized.

The “highly bioactive” polyphenols likely “underlie EVOO’s numerous cardiometabolic benefits,” the researchers wrote, noting that the 2014 PREDIMED trial provided “first-level scientific evidence of [EVOO’s] cardioprotective effects [if used] within the context of the Mediterranean diet.”

The authors recommend “generous use” of EVOO in salad dressings and vegetable dishes, pasta, rice, fish, sauces, or legumes.

They also review the role of tree nuts, noting that they are “nutrient-dense foods rich in unsaturated fats, fiber, protein, polyphenols, phytosterols, tocopherols, and nonsodium minerals” and have been shown beneficial in CVD prevention.

Legumes play a “central role” in the Mediterranean diet and are an “excellent source” of vegetable protein, folate, magnesium, and fiber. Legume consumption is associated with lowered risk for CVD, as well as improved blood glucose, cholesterol, blood pressure, and body weight, the authors stated.

Whole grains like barley, whole oats, brown rice, and quinoa are likewise central components of the traditional Mediterranean diet. The authors warned that refined grain products and commercial precooked pasta or pizza should be “consumed only in small amounts.”
 

Window of time

In time-restricted eating (which is one type of intermittent fasting), the daily intake of food is limited to a window of time, usually 6-12 hours each day, the authors explained.

When done regularly, this type of eating has been shown to both decrease intra-abdominal adipose tissue and reduce free-radical production. Additionally, it “elicits powerful cellular responses” that may reduce risks for systemic inflammation, diabetes, CVD, cancer, and neurodegenerative diseases.

However, the authors warned, the evidence supporting time-restricted eating is still preliminary.
 

‘Let food be thy medicine’

Andrew Freeman, MD, cochair of the ACC’s nutrition & lifestyle work group, cautioned that many American plant-based Mediterranean diets often include large amount of feta cheese and lamb and foods are often “heavily doused” in olive oil, while the traditional Mediterranean diet consists primarily of greens and lentils and is plant based.

“The goal would be to have a whole grain and leafy vegetables as the center of the meal, and – if an animal product such as fish is included – it should be limited to as little as possible and used as the garnish rather than the main dish,” he stated.

Moreover, fish are often exposed to large amount of toxins, heavy metals, and microplastics, so “don’t overdo eating fish,” he advised.

Dr. Freeman said that intermittent fasting “has a lot of promise and no harm” and concentrating food consumption during a shorter period in the day instead of “grazing throughout the day” will reduce constant snacking. “But don’t gorge yourself during those hours,” he warned.

Dr. Freeman concluded by citing the guidance of Hippocrates: “Let food be thy medicine.

“There’s some real truth to that,” he added.

No source of funding was listed. Dr. Smith and Dr. Freeman disclosed no relevant financial relationships. Dr. O’Keefe has a major ownership interest in CardioTabs, a supplement company that sells some products containing omega-3 fatty acids.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A new study using cardiac magnetic resonance (CMR) imaging to examine the effects of novel coronavirus infection on the heart showed signs suggestive of myocarditis in 4 out of 26 competitive athletes who recovered from asymptomatic or mild cases of COVID-19.

While these and other similar findings are concerning, commentators are saying the results are preliminary and do not indicate widespread CMR screening is appropriate.

Two of the 4 patients showing signs of myocarditis in this series had no symptoms of COVID-19 but tested positive on routine testing. An additional 12 student athletes (46%) showed late gadolinium enhancement (LGE), of whom 8 (30.8%) had LGE without T2 elevation suggestive of prior myocardial injury.

An additional 12 student athletes (46%) showed late gadolinium enhancement (LGE), of whom 8 (31%) had LGE without T2 elevation suggestive of prior myocardial injury.

This finding, said Saurabh Rajpal, MBBS, MD, the study’s lead author, “could suggest prior myocardial injury or it could suggest athletic myocardial adaptation.”

In a research letter published in JAMA Cardiology, Rajpal and colleagues at Ohio State University in Columbus, described the findings of comprehensive CMR examinations in competitive athletes referred to the sport medicine clinic after testing positive for COVID-19 on reverse transcriptase-polymerase chain reaction between June and August 2020.

The university had made the decision in the spring to use CMR imaging as a screening tool for return to play, said Dr. Rajpal. While CMR is being used for research purposes, the American College of Cardiology’s recent “consensus expert opinion” statement on resumption of sport and exercise after COVID-19 infection does not require CMR imaging for resumption of competitive activity (JAMA Cardiol. 2020 May 13. doi:10.1001/jamacardio.2020.2136).

None of the athletes required hospitalization for their illness, and only 27% reported mild symptoms during the short-term infection, including sore throat, shortness of breath, myalgia, and fever.

On the day of CMR imaging, ECG and transthoracic echocardiography were performed, and serum troponin I was measured. There were no diagnostic ST/T wave changes, ventricular function and volumes were normal, and no athletes showed elevated serum troponin levels.

The updated Lake Louise Criteria were used to assess CMR findings consistent with myocarditis.

“I don’t think this is a COVID-specific issue. We have seen myocarditis after other viral infections; it’s just that COVID-19 is the most studied thus far, and with strenuous activity, inflammation in the heart can be risky,” Dr. Rajpal said in an interview. He added that more long-term and larger studies with control populations are needed.

His group is continuing to follow these athletes and has suggested that CMR “may provide an excellent risk-stratification assessment for myocarditis in athletes who have recovered from COVID-19 to guide safe competitive sports participation.”
 

Significance still unknown

Matthew Martinez, MD, the director of sports cardiology at Atlantic Health – Morristown (N.J.) Medical Center and the Gagnon Cardiovascular Institute, urged caution in making too much of the findings of this small study.

“We know that viruses cause myocardial damage and myocarditis. What we don’t know is how important these findings are. And in terms of risk, would we find the same phenomenon if we did this, say, in flu patients or in other age groups?” Dr. Martinez said in an interview.

“I haven’t seen all the images, but what I’d want to know is are these very subtle findings? Are these overt findings? Is this part of an active individual with symptoms? I need to know a little more data before I can tell if this influences the increased risk of sudden cardiac death that we often associate with myocarditis. I’m not sure how this should influence making decisions with regards to return to play.”

Dr. Martinez, who is the ACC’s chair of Sports and Exercise but was not an author of their recent guidance on return to sport, said that he is not routinely using CMR to assess athletes post-infection, as per the ACC’s recommendations.

“My approach is to evaluate anybody with a history of COVID infection and, first, determine whether it was an important infection with significant symptoms or not. And then, if they’re participating at a high level or are professional athletes, I would suggest an ECG, echo, and troponin. That’s our recommendation for the last several months and is still an appropriate way to evaluate that group.”

“In the presence of an abnormality or ongoing symptoms, I would ask for an MRI at that point,” said Dr. Martinez.

“We just don’t have much data on athletes with no symptoms to use to interpret these CMR findings and the study didn’t offer any controls. We don’t even know if these findings are new findings or old findings that have just been identified now,” he added.

New, updated recommendations from the ACC are coming soon, said Dr. Martinez. “I do not expect them to include CMR as first line.”
 

Cardiologists concerned about misinformation

This is at least the fourth study showing myocardial damage post-COVID-19 infection and there is concern in the medical community that the media has overstated the risks of heart damage, especially in athletes, and at the same time overstated the benefits of CMR.

In particular, Puntmann et al reported in July a 100-patient study that showed evidence of myocardial inflammation by CMR in 78% of patients recently recovered from a bout of COVID-19 (JAMA Cardiol. 2020 Jul 27; doi:10.1001/jamacardio.2020.3557).

“That paper is completely problematic,” John Mandrola, MD, of Baptists Medical Associates, Louisville, Ky., said in an interview. “It has the same overarching weaknesses [of other studies] that it’s observational and retrospective, but there were also numerical issues. So to me that paper is an interesting observation, but utterly unconvincing and preliminary,” said Dr. Mandrola.

Those limitations didn’t stop the study from garnering media attention, however. The Altmetric score (an attention score that tracks all mentions of an article in the media and on social media) for the Puntmann et al paper is approaching 13,000, including coverage from 276 news outlets and more than 19,000 tweets, putting it in the 99th percentile of all research outputs tracked by Altmetric to date.

To counter this, an “open letter” posted online just days before the Rajpal study published urging professional societies to “offer clear guidance discouraging CMR screening for COVID-19 related heart abnormalities in asymptomatic members of the general public.” The letter was signed by 51 clinicians, researchers, and imaging specialists from around the world.

Dr. Mandrola, one of the signatories, said: “This topic really scares people, and when it gets in the media like this, I think the leaders of these societies need to come out and say something really clear on major news networks letting people know that it’s just way too premature to start doing CMRs on every athlete that’s gotten this virus.”

“I understand that the current guidelines may be clear that CMR is not a first-line test for this indication, but when the media coverage is so extensive and so overblown, I wonder how much impact the guidelines will have in countering this fear that’s in the community,” he added.

Asked to comment on the letter, Dr. Rajpal said he agrees with the signatories that asymptomatic people from general population do not need routine cardiac MRI. “However, competitive athletes are a different story. Testing depends on risk assessment in specific population and competitive athletes as per our protocol will get enhanced cardiac workup including CMR for responsible and safe start of competitive sports. ... In the present scenario, while we get more data including control data, we will continue with our current protocol.”

Dr. Mandrola is Medscape Cardiology’s Chief Cardiology Consultant. MDedge is part of the Medscape Professional Network.

This article first appeared on Medscape.com.

A new study using cardiac magnetic resonance (CMR) imaging to examine the effects of novel coronavirus infection on the heart showed signs suggestive of myocarditis in 4 out of 26 competitive athletes who recovered from asymptomatic or mild cases of COVID-19.

While these and other similar findings are concerning, commentators are saying the results are preliminary and do not indicate widespread CMR screening is appropriate.

Two of the 4 patients showing signs of myocarditis in this series had no symptoms of COVID-19 but tested positive on routine testing. An additional 12 student athletes (46%) showed late gadolinium enhancement (LGE), of whom 8 (30.8%) had LGE without T2 elevation suggestive of prior myocardial injury.

An additional 12 student athletes (46%) showed late gadolinium enhancement (LGE), of whom 8 (31%) had LGE without T2 elevation suggestive of prior myocardial injury.

This finding, said Saurabh Rajpal, MBBS, MD, the study’s lead author, “could suggest prior myocardial injury or it could suggest athletic myocardial adaptation.”

In a research letter published in JAMA Cardiology, Rajpal and colleagues at Ohio State University in Columbus, described the findings of comprehensive CMR examinations in competitive athletes referred to the sport medicine clinic after testing positive for COVID-19 on reverse transcriptase-polymerase chain reaction between June and August 2020.

The university had made the decision in the spring to use CMR imaging as a screening tool for return to play, said Dr. Rajpal. While CMR is being used for research purposes, the American College of Cardiology’s recent “consensus expert opinion” statement on resumption of sport and exercise after COVID-19 infection does not require CMR imaging for resumption of competitive activity (JAMA Cardiol. 2020 May 13. doi:10.1001/jamacardio.2020.2136).

None of the athletes required hospitalization for their illness, and only 27% reported mild symptoms during the short-term infection, including sore throat, shortness of breath, myalgia, and fever.

On the day of CMR imaging, ECG and transthoracic echocardiography were performed, and serum troponin I was measured. There were no diagnostic ST/T wave changes, ventricular function and volumes were normal, and no athletes showed elevated serum troponin levels.

The updated Lake Louise Criteria were used to assess CMR findings consistent with myocarditis.

“I don’t think this is a COVID-specific issue. We have seen myocarditis after other viral infections; it’s just that COVID-19 is the most studied thus far, and with strenuous activity, inflammation in the heart can be risky,” Dr. Rajpal said in an interview. He added that more long-term and larger studies with control populations are needed.

His group is continuing to follow these athletes and has suggested that CMR “may provide an excellent risk-stratification assessment for myocarditis in athletes who have recovered from COVID-19 to guide safe competitive sports participation.”
 

Significance still unknown

Matthew Martinez, MD, the director of sports cardiology at Atlantic Health – Morristown (N.J.) Medical Center and the Gagnon Cardiovascular Institute, urged caution in making too much of the findings of this small study.

“We know that viruses cause myocardial damage and myocarditis. What we don’t know is how important these findings are. And in terms of risk, would we find the same phenomenon if we did this, say, in flu patients or in other age groups?” Dr. Martinez said in an interview.

“I haven’t seen all the images, but what I’d want to know is are these very subtle findings? Are these overt findings? Is this part of an active individual with symptoms? I need to know a little more data before I can tell if this influences the increased risk of sudden cardiac death that we often associate with myocarditis. I’m not sure how this should influence making decisions with regards to return to play.”

Dr. Martinez, who is the ACC’s chair of Sports and Exercise but was not an author of their recent guidance on return to sport, said that he is not routinely using CMR to assess athletes post-infection, as per the ACC’s recommendations.

“My approach is to evaluate anybody with a history of COVID infection and, first, determine whether it was an important infection with significant symptoms or not. And then, if they’re participating at a high level or are professional athletes, I would suggest an ECG, echo, and troponin. That’s our recommendation for the last several months and is still an appropriate way to evaluate that group.”

“In the presence of an abnormality or ongoing symptoms, I would ask for an MRI at that point,” said Dr. Martinez.

“We just don’t have much data on athletes with no symptoms to use to interpret these CMR findings and the study didn’t offer any controls. We don’t even know if these findings are new findings or old findings that have just been identified now,” he added.

New, updated recommendations from the ACC are coming soon, said Dr. Martinez. “I do not expect them to include CMR as first line.”
 

Cardiologists concerned about misinformation

This is at least the fourth study showing myocardial damage post-COVID-19 infection and there is concern in the medical community that the media has overstated the risks of heart damage, especially in athletes, and at the same time overstated the benefits of CMR.

In particular, Puntmann et al reported in July a 100-patient study that showed evidence of myocardial inflammation by CMR in 78% of patients recently recovered from a bout of COVID-19 (JAMA Cardiol. 2020 Jul 27; doi:10.1001/jamacardio.2020.3557).

“That paper is completely problematic,” John Mandrola, MD, of Baptists Medical Associates, Louisville, Ky., said in an interview. “It has the same overarching weaknesses [of other studies] that it’s observational and retrospective, but there were also numerical issues. So to me that paper is an interesting observation, but utterly unconvincing and preliminary,” said Dr. Mandrola.

Those limitations didn’t stop the study from garnering media attention, however. The Altmetric score (an attention score that tracks all mentions of an article in the media and on social media) for the Puntmann et al paper is approaching 13,000, including coverage from 276 news outlets and more than 19,000 tweets, putting it in the 99th percentile of all research outputs tracked by Altmetric to date.

To counter this, an “open letter” posted online just days before the Rajpal study published urging professional societies to “offer clear guidance discouraging CMR screening for COVID-19 related heart abnormalities in asymptomatic members of the general public.” The letter was signed by 51 clinicians, researchers, and imaging specialists from around the world.

Dr. Mandrola, one of the signatories, said: “This topic really scares people, and when it gets in the media like this, I think the leaders of these societies need to come out and say something really clear on major news networks letting people know that it’s just way too premature to start doing CMRs on every athlete that’s gotten this virus.”

“I understand that the current guidelines may be clear that CMR is not a first-line test for this indication, but when the media coverage is so extensive and so overblown, I wonder how much impact the guidelines will have in countering this fear that’s in the community,” he added.

Asked to comment on the letter, Dr. Rajpal said he agrees with the signatories that asymptomatic people from general population do not need routine cardiac MRI. “However, competitive athletes are a different story. Testing depends on risk assessment in specific population and competitive athletes as per our protocol will get enhanced cardiac workup including CMR for responsible and safe start of competitive sports. ... In the present scenario, while we get more data including control data, we will continue with our current protocol.”

Dr. Mandrola is Medscape Cardiology’s Chief Cardiology Consultant. MDedge is part of the Medscape Professional Network.

This article first appeared on Medscape.com.

A new study using cardiac magnetic resonance (CMR) imaging to examine the effects of novel coronavirus infection on the heart showed signs suggestive of myocarditis in 4 out of 26 competitive athletes who recovered from asymptomatic or mild cases of COVID-19.

While these and other similar findings are concerning, commentators are saying the results are preliminary and do not indicate widespread CMR screening is appropriate.

Two of the 4 patients showing signs of myocarditis in this series had no symptoms of COVID-19 but tested positive on routine testing. An additional 12 student athletes (46%) showed late gadolinium enhancement (LGE), of whom 8 (30.8%) had LGE without T2 elevation suggestive of prior myocardial injury.

An additional 12 student athletes (46%) showed late gadolinium enhancement (LGE), of whom 8 (31%) had LGE without T2 elevation suggestive of prior myocardial injury.

This finding, said Saurabh Rajpal, MBBS, MD, the study’s lead author, “could suggest prior myocardial injury or it could suggest athletic myocardial adaptation.”

In a research letter published in JAMA Cardiology, Rajpal and colleagues at Ohio State University in Columbus, described the findings of comprehensive CMR examinations in competitive athletes referred to the sport medicine clinic after testing positive for COVID-19 on reverse transcriptase-polymerase chain reaction between June and August 2020.

The university had made the decision in the spring to use CMR imaging as a screening tool for return to play, said Dr. Rajpal. While CMR is being used for research purposes, the American College of Cardiology’s recent “consensus expert opinion” statement on resumption of sport and exercise after COVID-19 infection does not require CMR imaging for resumption of competitive activity (JAMA Cardiol. 2020 May 13. doi:10.1001/jamacardio.2020.2136).

None of the athletes required hospitalization for their illness, and only 27% reported mild symptoms during the short-term infection, including sore throat, shortness of breath, myalgia, and fever.

On the day of CMR imaging, ECG and transthoracic echocardiography were performed, and serum troponin I was measured. There were no diagnostic ST/T wave changes, ventricular function and volumes were normal, and no athletes showed elevated serum troponin levels.

The updated Lake Louise Criteria were used to assess CMR findings consistent with myocarditis.

“I don’t think this is a COVID-specific issue. We have seen myocarditis after other viral infections; it’s just that COVID-19 is the most studied thus far, and with strenuous activity, inflammation in the heart can be risky,” Dr. Rajpal said in an interview. He added that more long-term and larger studies with control populations are needed.

His group is continuing to follow these athletes and has suggested that CMR “may provide an excellent risk-stratification assessment for myocarditis in athletes who have recovered from COVID-19 to guide safe competitive sports participation.”
 

Significance still unknown

Matthew Martinez, MD, the director of sports cardiology at Atlantic Health – Morristown (N.J.) Medical Center and the Gagnon Cardiovascular Institute, urged caution in making too much of the findings of this small study.

“We know that viruses cause myocardial damage and myocarditis. What we don’t know is how important these findings are. And in terms of risk, would we find the same phenomenon if we did this, say, in flu patients or in other age groups?” Dr. Martinez said in an interview.

“I haven’t seen all the images, but what I’d want to know is are these very subtle findings? Are these overt findings? Is this part of an active individual with symptoms? I need to know a little more data before I can tell if this influences the increased risk of sudden cardiac death that we often associate with myocarditis. I’m not sure how this should influence making decisions with regards to return to play.”

Dr. Martinez, who is the ACC’s chair of Sports and Exercise but was not an author of their recent guidance on return to sport, said that he is not routinely using CMR to assess athletes post-infection, as per the ACC’s recommendations.

“My approach is to evaluate anybody with a history of COVID infection and, first, determine whether it was an important infection with significant symptoms or not. And then, if they’re participating at a high level or are professional athletes, I would suggest an ECG, echo, and troponin. That’s our recommendation for the last several months and is still an appropriate way to evaluate that group.”

“In the presence of an abnormality or ongoing symptoms, I would ask for an MRI at that point,” said Dr. Martinez.

“We just don’t have much data on athletes with no symptoms to use to interpret these CMR findings and the study didn’t offer any controls. We don’t even know if these findings are new findings or old findings that have just been identified now,” he added.

New, updated recommendations from the ACC are coming soon, said Dr. Martinez. “I do not expect them to include CMR as first line.”
 

Cardiologists concerned about misinformation

This is at least the fourth study showing myocardial damage post-COVID-19 infection and there is concern in the medical community that the media has overstated the risks of heart damage, especially in athletes, and at the same time overstated the benefits of CMR.

In particular, Puntmann et al reported in July a 100-patient study that showed evidence of myocardial inflammation by CMR in 78% of patients recently recovered from a bout of COVID-19 (JAMA Cardiol. 2020 Jul 27; doi:10.1001/jamacardio.2020.3557).

“That paper is completely problematic,” John Mandrola, MD, of Baptists Medical Associates, Louisville, Ky., said in an interview. “It has the same overarching weaknesses [of other studies] that it’s observational and retrospective, but there were also numerical issues. So to me that paper is an interesting observation, but utterly unconvincing and preliminary,” said Dr. Mandrola.

Those limitations didn’t stop the study from garnering media attention, however. The Altmetric score (an attention score that tracks all mentions of an article in the media and on social media) for the Puntmann et al paper is approaching 13,000, including coverage from 276 news outlets and more than 19,000 tweets, putting it in the 99th percentile of all research outputs tracked by Altmetric to date.

To counter this, an “open letter” posted online just days before the Rajpal study published urging professional societies to “offer clear guidance discouraging CMR screening for COVID-19 related heart abnormalities in asymptomatic members of the general public.” The letter was signed by 51 clinicians, researchers, and imaging specialists from around the world.

Dr. Mandrola, one of the signatories, said: “This topic really scares people, and when it gets in the media like this, I think the leaders of these societies need to come out and say something really clear on major news networks letting people know that it’s just way too premature to start doing CMRs on every athlete that’s gotten this virus.”

“I understand that the current guidelines may be clear that CMR is not a first-line test for this indication, but when the media coverage is so extensive and so overblown, I wonder how much impact the guidelines will have in countering this fear that’s in the community,” he added.

Asked to comment on the letter, Dr. Rajpal said he agrees with the signatories that asymptomatic people from general population do not need routine cardiac MRI. “However, competitive athletes are a different story. Testing depends on risk assessment in specific population and competitive athletes as per our protocol will get enhanced cardiac workup including CMR for responsible and safe start of competitive sports. ... In the present scenario, while we get more data including control data, we will continue with our current protocol.”

Dr. Mandrola is Medscape Cardiology’s Chief Cardiology Consultant. MDedge is part of the Medscape Professional Network.

This article first appeared on Medscape.com.

Low-dose aspirin may be considered for the primary prevention of cardiovascular disease (CVD) in patients with autoimmune systemic rheumatic diseases who are at particularly high risk because of their individual cardiovascular risk profile, according to authors of a new review article in the journal Rheumatology who acknowledge the controversial nature of the issue, because while significant cardiovascular benefit from aspirin for secondary prevention is well established, it has not been for primary prevention.

Secondary prevention with daily, low-dose aspirin is part of aggressive, comprehensive risk modification in patients who have experienced an MI or stroke or are considered at high risk for CVD. But when it comes to primary prevention of the onset of disease, the authors, led by Serena Fasano, MD, PhD, of the rheumatology unit at the University of Campania, Naples, Italy, acknowledged the contradictory positions of international guidelines and uncertainty over balancing benefit versus harm – including risk of mortality in the context of excess bleeding. They called for “robust data” from high-quality randomized, controlled trials for subgroups of patients with specific rheumatologic diseases in order to better answer the question of aspirin for primary prevention.

“This review is devoted to reporting the present knowledge on the effectiveness of low-dose [aspirin] in primary CV prevention in a number of autoimmune systemic rheumatic diseases, not a systematic review or meta-analysis,” the authors stated. “We are not claiming to have covered more than a selection of the literature for each disease. Available data are not high-quality data and do not provide firm conclusions.”

The authors focused primarily on accelerated, rather than spontaneous, atherosclerosis or buildup of plaque in artery walls, implicated in ischemic heart diseases such as MI and ischemic cerebrovascular diseases such as stroke. They looked at its association with autoimmune rheumatic diseases, primarily systemic lupus erythematosus (SLE) and RA, but also including antiphospholipid syndrome, systemic sclerosis, mixed connective tissue disease, dermatomyositis/polymyositis, primary Sjögren’s syndrome, and systemic vasculitis.

They shared results from a review of 167 patients with SLE consecutively admitted to their tertiary medical center who had not previously experienced a cardiovascular event and who were prescribed low-dose (100 mg) aspirin on their first visit and followed for 8 years. The cardiovascular event-free rate was higher in the aspirin group and no excess bleeding was noted, although this may be attributable to a younger patient population and routine use of proton pump inhibitors. Subsequently, hydroxychloroquine was added to the aspirin treatment and was associated with further reduction in cardiovascular events.

The research group also conducted a retrospective analysis of 746 patients with RA consecutively admitted to four tertiary medical centers who hadn’t experienced a cardiovascular event previously. Incidence of cardiovascular events was significantly lower in aspirin-treated patients.
 

Individualized aspirin prescribing with cardiologist comanagement

There may be a modest benefit of using low-dose aspirin on a long-term basis, but that benefit needs to be offset by the risk of bleeds, said M. Elaine Husni, MD, MPH, vice chair of rheumatology and director of the Arthritis and Musculoskeletal Center at the Cleveland Clinic. It’s important to remind clinicians of cardiovascular risk, she said. “But the message for rheumatologists is it needs to be prescribed on an individual basis, rather than based on diagnosis of a rheumatic condition – at least until we have better evidence.”

Dr. Husni recommended keeping an open mind regarding individual approaches – for example, low-dose aspirin plus statins. A composite approach to prevention likely is called for, including attention to lifestyle issues such as smoking cessation, exercise, and weight loss. “That kind of complexity in decision-making highlights the need for comanagement with a cardiologist,” she said. “I’m a big believer in comanagement. At my multidisciplinary medical center, I am able to pick up the phone and talk to a cardiologist with whom our group has a relationship.” If physicians don’t have that kind of relationship with a cardiology group, she suggested reaching out to establish one.

The review paper could give some guidance to rheumatologists for use on an individual case, Michael Nurmohamed, MD, PhD, of the Amsterdam Rheumatology and Immunology Center in the Netherlands commented in an interview. “However, firm recommendations cannot be given as proper investigations are still lacking, as acknowledged by the authors. In addition, the review paper itself has some methodological constraints. Although this is a narrative review, the search strategy should have been specified, and a quality assessment of the individual studies is lacking.”

There is no doubt that the CVD burden in RA and other rheumatologic conditions is substantially increased in comparison to the general population, Dr. Nurmohamed said. That has been assessed by several well-designed, prospective, controlled studies. Other relatively frequent inflammatory arthropathies, including ankylosing spondylitis and psoriatic arthritis, also pose cardiovascular risk.

“Aspirin cannot be recommended for primary CVD prevention in inflammatory arthropathies due to the absence of adequate studies. That’s why the EULAR [European League Against Rheumatism] guidelines did not recommend its use,” he said. Currently, a EULAR task force is developing evidence-based guidelines for primary CVD prevention in the diseases discussed by Fasano et al., where the use of aspirin will be reassessed. “As these guidelines will consider the methodological quality of the underlying studies, they will enable a more refined use of aspirin in daily clinical practice.”

Primary prevention of CVD using aspirin is not currently the standard of care in taking care of patients with rheumatologic disease in the Netherlands, Ronald F. van Vollenhoven, MD, PhD, Dr. Nurmohamed’s colleague and director of the Amsterdam Rheumatology and Immunology Center and the chair of the department of rheumatology and clinical immunology at the Amsterdam University Medical Center, said in an interview.

“One reason may be the limited data, as highlighted in the review by Dr. Fasano and colleagues. However, another consideration is the problem of polypharmacy. Rheumatic diseases usually require chronic treatment, sometimes with multiple medications. This makes it even more of a concern to add an additional medication, even a relatively innocuous one such as low-dose aspirin,” he said.

Dr. Husni, Dr. Nurmohamed, and Dr. van Vollenhoven reported having no relevant disclosures. The authors of the review article had no relevant disclosures.

SOURCE: Fasano S et al. Rheumatology. 2020 Aug 25. doi: 10.1093/rheumatology/keaa335.

Low-dose aspirin may be considered for the primary prevention of cardiovascular disease (CVD) in patients with autoimmune systemic rheumatic diseases who are at particularly high risk because of their individual cardiovascular risk profile, according to authors of a new review article in the journal Rheumatology who acknowledge the controversial nature of the issue, because while significant cardiovascular benefit from aspirin for secondary prevention is well established, it has not been for primary prevention.

Secondary prevention with daily, low-dose aspirin is part of aggressive, comprehensive risk modification in patients who have experienced an MI or stroke or are considered at high risk for CVD. But when it comes to primary prevention of the onset of disease, the authors, led by Serena Fasano, MD, PhD, of the rheumatology unit at the University of Campania, Naples, Italy, acknowledged the contradictory positions of international guidelines and uncertainty over balancing benefit versus harm – including risk of mortality in the context of excess bleeding. They called for “robust data” from high-quality randomized, controlled trials for subgroups of patients with specific rheumatologic diseases in order to better answer the question of aspirin for primary prevention.

“This review is devoted to reporting the present knowledge on the effectiveness of low-dose [aspirin] in primary CV prevention in a number of autoimmune systemic rheumatic diseases, not a systematic review or meta-analysis,” the authors stated. “We are not claiming to have covered more than a selection of the literature for each disease. Available data are not high-quality data and do not provide firm conclusions.”

The authors focused primarily on accelerated, rather than spontaneous, atherosclerosis or buildup of plaque in artery walls, implicated in ischemic heart diseases such as MI and ischemic cerebrovascular diseases such as stroke. They looked at its association with autoimmune rheumatic diseases, primarily systemic lupus erythematosus (SLE) and RA, but also including antiphospholipid syndrome, systemic sclerosis, mixed connective tissue disease, dermatomyositis/polymyositis, primary Sjögren’s syndrome, and systemic vasculitis.

They shared results from a review of 167 patients with SLE consecutively admitted to their tertiary medical center who had not previously experienced a cardiovascular event and who were prescribed low-dose (100 mg) aspirin on their first visit and followed for 8 years. The cardiovascular event-free rate was higher in the aspirin group and no excess bleeding was noted, although this may be attributable to a younger patient population and routine use of proton pump inhibitors. Subsequently, hydroxychloroquine was added to the aspirin treatment and was associated with further reduction in cardiovascular events.

The research group also conducted a retrospective analysis of 746 patients with RA consecutively admitted to four tertiary medical centers who hadn’t experienced a cardiovascular event previously. Incidence of cardiovascular events was significantly lower in aspirin-treated patients.
 

Individualized aspirin prescribing with cardiologist comanagement

There may be a modest benefit of using low-dose aspirin on a long-term basis, but that benefit needs to be offset by the risk of bleeds, said M. Elaine Husni, MD, MPH, vice chair of rheumatology and director of the Arthritis and Musculoskeletal Center at the Cleveland Clinic. It’s important to remind clinicians of cardiovascular risk, she said. “But the message for rheumatologists is it needs to be prescribed on an individual basis, rather than based on diagnosis of a rheumatic condition – at least until we have better evidence.”

Dr. Husni recommended keeping an open mind regarding individual approaches – for example, low-dose aspirin plus statins. A composite approach to prevention likely is called for, including attention to lifestyle issues such as smoking cessation, exercise, and weight loss. “That kind of complexity in decision-making highlights the need for comanagement with a cardiologist,” she said. “I’m a big believer in comanagement. At my multidisciplinary medical center, I am able to pick up the phone and talk to a cardiologist with whom our group has a relationship.” If physicians don’t have that kind of relationship with a cardiology group, she suggested reaching out to establish one.

The review paper could give some guidance to rheumatologists for use on an individual case, Michael Nurmohamed, MD, PhD, of the Amsterdam Rheumatology and Immunology Center in the Netherlands commented in an interview. “However, firm recommendations cannot be given as proper investigations are still lacking, as acknowledged by the authors. In addition, the review paper itself has some methodological constraints. Although this is a narrative review, the search strategy should have been specified, and a quality assessment of the individual studies is lacking.”

There is no doubt that the CVD burden in RA and other rheumatologic conditions is substantially increased in comparison to the general population, Dr. Nurmohamed said. That has been assessed by several well-designed, prospective, controlled studies. Other relatively frequent inflammatory arthropathies, including ankylosing spondylitis and psoriatic arthritis, also pose cardiovascular risk.

“Aspirin cannot be recommended for primary CVD prevention in inflammatory arthropathies due to the absence of adequate studies. That’s why the EULAR [European League Against Rheumatism] guidelines did not recommend its use,” he said. Currently, a EULAR task force is developing evidence-based guidelines for primary CVD prevention in the diseases discussed by Fasano et al., where the use of aspirin will be reassessed. “As these guidelines will consider the methodological quality of the underlying studies, they will enable a more refined use of aspirin in daily clinical practice.”

Primary prevention of CVD using aspirin is not currently the standard of care in taking care of patients with rheumatologic disease in the Netherlands, Ronald F. van Vollenhoven, MD, PhD, Dr. Nurmohamed’s colleague and director of the Amsterdam Rheumatology and Immunology Center and the chair of the department of rheumatology and clinical immunology at the Amsterdam University Medical Center, said in an interview.

“One reason may be the limited data, as highlighted in the review by Dr. Fasano and colleagues. However, another consideration is the problem of polypharmacy. Rheumatic diseases usually require chronic treatment, sometimes with multiple medications. This makes it even more of a concern to add an additional medication, even a relatively innocuous one such as low-dose aspirin,” he said.

Dr. Husni, Dr. Nurmohamed, and Dr. van Vollenhoven reported having no relevant disclosures. The authors of the review article had no relevant disclosures.

SOURCE: Fasano S et al. Rheumatology. 2020 Aug 25. doi: 10.1093/rheumatology/keaa335.

Low-dose aspirin may be considered for the primary prevention of cardiovascular disease (CVD) in patients with autoimmune systemic rheumatic diseases who are at particularly high risk because of their individual cardiovascular risk profile, according to authors of a new review article in the journal Rheumatology who acknowledge the controversial nature of the issue, because while significant cardiovascular benefit from aspirin for secondary prevention is well established, it has not been for primary prevention.

Secondary prevention with daily, low-dose aspirin is part of aggressive, comprehensive risk modification in patients who have experienced an MI or stroke or are considered at high risk for CVD. But when it comes to primary prevention of the onset of disease, the authors, led by Serena Fasano, MD, PhD, of the rheumatology unit at the University of Campania, Naples, Italy, acknowledged the contradictory positions of international guidelines and uncertainty over balancing benefit versus harm – including risk of mortality in the context of excess bleeding. They called for “robust data” from high-quality randomized, controlled trials for subgroups of patients with specific rheumatologic diseases in order to better answer the question of aspirin for primary prevention.

“This review is devoted to reporting the present knowledge on the effectiveness of low-dose [aspirin] in primary CV prevention in a number of autoimmune systemic rheumatic diseases, not a systematic review or meta-analysis,” the authors stated. “We are not claiming to have covered more than a selection of the literature for each disease. Available data are not high-quality data and do not provide firm conclusions.”

The authors focused primarily on accelerated, rather than spontaneous, atherosclerosis or buildup of plaque in artery walls, implicated in ischemic heart diseases such as MI and ischemic cerebrovascular diseases such as stroke. They looked at its association with autoimmune rheumatic diseases, primarily systemic lupus erythematosus (SLE) and RA, but also including antiphospholipid syndrome, systemic sclerosis, mixed connective tissue disease, dermatomyositis/polymyositis, primary Sjögren’s syndrome, and systemic vasculitis.

They shared results from a review of 167 patients with SLE consecutively admitted to their tertiary medical center who had not previously experienced a cardiovascular event and who were prescribed low-dose (100 mg) aspirin on their first visit and followed for 8 years. The cardiovascular event-free rate was higher in the aspirin group and no excess bleeding was noted, although this may be attributable to a younger patient population and routine use of proton pump inhibitors. Subsequently, hydroxychloroquine was added to the aspirin treatment and was associated with further reduction in cardiovascular events.

The research group also conducted a retrospective analysis of 746 patients with RA consecutively admitted to four tertiary medical centers who hadn’t experienced a cardiovascular event previously. Incidence of cardiovascular events was significantly lower in aspirin-treated patients.
 

Individualized aspirin prescribing with cardiologist comanagement

There may be a modest benefit of using low-dose aspirin on a long-term basis, but that benefit needs to be offset by the risk of bleeds, said M. Elaine Husni, MD, MPH, vice chair of rheumatology and director of the Arthritis and Musculoskeletal Center at the Cleveland Clinic. It’s important to remind clinicians of cardiovascular risk, she said. “But the message for rheumatologists is it needs to be prescribed on an individual basis, rather than based on diagnosis of a rheumatic condition – at least until we have better evidence.”

Dr. Husni recommended keeping an open mind regarding individual approaches – for example, low-dose aspirin plus statins. A composite approach to prevention likely is called for, including attention to lifestyle issues such as smoking cessation, exercise, and weight loss. “That kind of complexity in decision-making highlights the need for comanagement with a cardiologist,” she said. “I’m a big believer in comanagement. At my multidisciplinary medical center, I am able to pick up the phone and talk to a cardiologist with whom our group has a relationship.” If physicians don’t have that kind of relationship with a cardiology group, she suggested reaching out to establish one.

The review paper could give some guidance to rheumatologists for use on an individual case, Michael Nurmohamed, MD, PhD, of the Amsterdam Rheumatology and Immunology Center in the Netherlands commented in an interview. “However, firm recommendations cannot be given as proper investigations are still lacking, as acknowledged by the authors. In addition, the review paper itself has some methodological constraints. Although this is a narrative review, the search strategy should have been specified, and a quality assessment of the individual studies is lacking.”

There is no doubt that the CVD burden in RA and other rheumatologic conditions is substantially increased in comparison to the general population, Dr. Nurmohamed said. That has been assessed by several well-designed, prospective, controlled studies. Other relatively frequent inflammatory arthropathies, including ankylosing spondylitis and psoriatic arthritis, also pose cardiovascular risk.

“Aspirin cannot be recommended for primary CVD prevention in inflammatory arthropathies due to the absence of adequate studies. That’s why the EULAR [European League Against Rheumatism] guidelines did not recommend its use,” he said. Currently, a EULAR task force is developing evidence-based guidelines for primary CVD prevention in the diseases discussed by Fasano et al., where the use of aspirin will be reassessed. “As these guidelines will consider the methodological quality of the underlying studies, they will enable a more refined use of aspirin in daily clinical practice.”

Primary prevention of CVD using aspirin is not currently the standard of care in taking care of patients with rheumatologic disease in the Netherlands, Ronald F. van Vollenhoven, MD, PhD, Dr. Nurmohamed’s colleague and director of the Amsterdam Rheumatology and Immunology Center and the chair of the department of rheumatology and clinical immunology at the Amsterdam University Medical Center, said in an interview.

“One reason may be the limited data, as highlighted in the review by Dr. Fasano and colleagues. However, another consideration is the problem of polypharmacy. Rheumatic diseases usually require chronic treatment, sometimes with multiple medications. This makes it even more of a concern to add an additional medication, even a relatively innocuous one such as low-dose aspirin,” he said.

Dr. Husni, Dr. Nurmohamed, and Dr. van Vollenhoven reported having no relevant disclosures. The authors of the review article had no relevant disclosures.

SOURCE: Fasano S et al. Rheumatology. 2020 Aug 25. doi: 10.1093/rheumatology/keaa335.

ANSWER

The correct answer is hidradenitis suppurativa (HS; choice “c”).

DISCUSSION

HS (also known as acne inversa) is a relatively common condition first described in 1839 by French physician Frederick Velpeau, who thought it was probably a form of acne. Because HS only affects intertriginous areas (groin, axillae, inframammary, intergluteal, and abdominal folds rich in apocrine glands), during the next 130 years, it was presumed that this disease was solely caused by malfunctioning apocrine glands.

Though experts disagree about the true etiology of HS, most agree that it is caused by several environmental and genetic factors leading to plugged or malfunctioning hair follicles and apocrine glands that become inflamed, swollen, painful, and purulent. In severe cases, tracts develop between lesions, resulting in the formation of ropy, linear hypertrophic scarring. Early on and in milder cases, comedones can manifest—often in multiples—along with widely scattered cysts. It appears that a case can be made for a genetic predisposition to develop HS because at least one-third of affected patients report a positive family history.

Females (usually postpubescent) are affected at 3 times the rate of males. Hormones, especially androgens, appear to play a role. This assertion is bolstered not only by the age of onset, but also because HS has been observed to improve after pregnancy and after menopause.

Though not causative, smoking and obesity have a strong statistical correlation with HS as exacerbating factors. Many patients with HS find movement from exercise too painful, which may contribute to obesity.

Because HS has a wide range of clinical presentations, the Hurley Staging scale can help clinicians distinguish the condition’s severity by stages I, II, or III. Stage I manifests with scant signs of disease, including comedones and sparsely separated small cysts. Stage II includes numerous painful cysts with tract formation between lesions. Stage III involves symptoms described in the other stages as well as multiple large, painful, draining cysts; widespread erythema; and extensive hypertrophic scarring.

Regarding the differential, the culture would have identified community-acquired methicillin-resistant Staphylococcus aureus (choice “a”) or flesh-eating bacterial infection (choice “d”), but neither would be as chronic as the patient’s disease. Acne conglobata (choice “b”) manifests with chronic dense acne largely confined to the trunk. Interestingly, acne conglobata, HS, dissecting cellulitis of the scalp, and pilonidal cyst are collectively known as the follicular occlusion tetrad.

TREATMENT

Treatment for HS is limited. Adalimumab is the most recent and promising biologic, though its use comes at a high cost ($60,000/y) and with an adverse effect profile that should give any prescriber pause. Also, the best one could hope for in using adalimumab is about a 30% improvement in the patient.

Before using a biologic, other options should at least be considered. Though not entirely satisfactory, there are oral antibiotics (minocycline, trimethoprim/sulfa, or a combination of rifampin and clindamycin) or intralesional steroids. Incision and drainage of individual lesions and isotretinoin therapy can temporarily relieve pain, but they are not effective as long-term therapies. Large-scale surgical extirpation of the affected tissue can be considered in extreme cases, but there can be recurrences and associated morbidity (eg, chronic lymphedema in the affected arm, extreme scarring, and postoperative pain).

ANSWER

The correct answer is hidradenitis suppurativa (HS; choice “c”).

DISCUSSION

HS (also known as acne inversa) is a relatively common condition first described in 1839 by French physician Frederick Velpeau, who thought it was probably a form of acne. Because HS only affects intertriginous areas (groin, axillae, inframammary, intergluteal, and abdominal folds rich in apocrine glands), during the next 130 years, it was presumed that this disease was solely caused by malfunctioning apocrine glands.

Though experts disagree about the true etiology of HS, most agree that it is caused by several environmental and genetic factors leading to plugged or malfunctioning hair follicles and apocrine glands that become inflamed, swollen, painful, and purulent. In severe cases, tracts develop between lesions, resulting in the formation of ropy, linear hypertrophic scarring. Early on and in milder cases, comedones can manifest—often in multiples—along with widely scattered cysts. It appears that a case can be made for a genetic predisposition to develop HS because at least one-third of affected patients report a positive family history.

Females (usually postpubescent) are affected at 3 times the rate of males. Hormones, especially androgens, appear to play a role. This assertion is bolstered not only by the age of onset, but also because HS has been observed to improve after pregnancy and after menopause.

Though not causative, smoking and obesity have a strong statistical correlation with HS as exacerbating factors. Many patients with HS find movement from exercise too painful, which may contribute to obesity.

Because HS has a wide range of clinical presentations, the Hurley Staging scale can help clinicians distinguish the condition’s severity by stages I, II, or III. Stage I manifests with scant signs of disease, including comedones and sparsely separated small cysts. Stage II includes numerous painful cysts with tract formation between lesions. Stage III involves symptoms described in the other stages as well as multiple large, painful, draining cysts; widespread erythema; and extensive hypertrophic scarring.

Regarding the differential, the culture would have identified community-acquired methicillin-resistant Staphylococcus aureus (choice “a”) or flesh-eating bacterial infection (choice “d”), but neither would be as chronic as the patient’s disease. Acne conglobata (choice “b”) manifests with chronic dense acne largely confined to the trunk. Interestingly, acne conglobata, HS, dissecting cellulitis of the scalp, and pilonidal cyst are collectively known as the follicular occlusion tetrad.

TREATMENT

Treatment for HS is limited. Adalimumab is the most recent and promising biologic, though its use comes at a high cost ($60,000/y) and with an adverse effect profile that should give any prescriber pause. Also, the best one could hope for in using adalimumab is about a 30% improvement in the patient.

Before using a biologic, other options should at least be considered. Though not entirely satisfactory, there are oral antibiotics (minocycline, trimethoprim/sulfa, or a combination of rifampin and clindamycin) or intralesional steroids. Incision and drainage of individual lesions and isotretinoin therapy can temporarily relieve pain, but they are not effective as long-term therapies. Large-scale surgical extirpation of the affected tissue can be considered in extreme cases, but there can be recurrences and associated morbidity (eg, chronic lymphedema in the affected arm, extreme scarring, and postoperative pain).

ANSWER

The correct answer is hidradenitis suppurativa (HS; choice “c”).

DISCUSSION

HS (also known as acne inversa) is a relatively common condition first described in 1839 by French physician Frederick Velpeau, who thought it was probably a form of acne. Because HS only affects intertriginous areas (groin, axillae, inframammary, intergluteal, and abdominal folds rich in apocrine glands), during the next 130 years, it was presumed that this disease was solely caused by malfunctioning apocrine glands.

Though experts disagree about the true etiology of HS, most agree that it is caused by several environmental and genetic factors leading to plugged or malfunctioning hair follicles and apocrine glands that become inflamed, swollen, painful, and purulent. In severe cases, tracts develop between lesions, resulting in the formation of ropy, linear hypertrophic scarring. Early on and in milder cases, comedones can manifest—often in multiples—along with widely scattered cysts. It appears that a case can be made for a genetic predisposition to develop HS because at least one-third of affected patients report a positive family history.

Females (usually postpubescent) are affected at 3 times the rate of males. Hormones, especially androgens, appear to play a role. This assertion is bolstered not only by the age of onset, but also because HS has been observed to improve after pregnancy and after menopause.

Though not causative, smoking and obesity have a strong statistical correlation with HS as exacerbating factors. Many patients with HS find movement from exercise too painful, which may contribute to obesity.

Because HS has a wide range of clinical presentations, the Hurley Staging scale can help clinicians distinguish the condition’s severity by stages I, II, or III. Stage I manifests with scant signs of disease, including comedones and sparsely separated small cysts. Stage II includes numerous painful cysts with tract formation between lesions. Stage III involves symptoms described in the other stages as well as multiple large, painful, draining cysts; widespread erythema; and extensive hypertrophic scarring.

Regarding the differential, the culture would have identified community-acquired methicillin-resistant Staphylococcus aureus (choice “a”) or flesh-eating bacterial infection (choice “d”), but neither would be as chronic as the patient’s disease. Acne conglobata (choice “b”) manifests with chronic dense acne largely confined to the trunk. Interestingly, acne conglobata, HS, dissecting cellulitis of the scalp, and pilonidal cyst are collectively known as the follicular occlusion tetrad.

TREATMENT

Treatment for HS is limited. Adalimumab is the most recent and promising biologic, though its use comes at a high cost ($60,000/y) and with an adverse effect profile that should give any prescriber pause. Also, the best one could hope for in using adalimumab is about a 30% improvement in the patient.

Before using a biologic, other options should at least be considered. Though not entirely satisfactory, there are oral antibiotics (minocycline, trimethoprim/sulfa, or a combination of rifampin and clindamycin) or intralesional steroids. Incision and drainage of individual lesions and isotretinoin therapy can temporarily relieve pain, but they are not effective as long-term therapies. Large-scale surgical extirpation of the affected tissue can be considered in extreme cases, but there can be recurrences and associated morbidity (eg, chronic lymphedema in the affected arm, extreme scarring, and postoperative pain).

Amid all the chaos and problems caused by COVID-19, one might hope that physicians would get a break on their complicated payment-reporting programs.

But that’s not the case: The government recently released the 2021 proposed rule for the Quality Payment Program (QPP), often referred to by its most popular participation track, the Merit-Based Incentive Payment System (MIPS). The program, which launched in 2017, gets annual updates, and this year is no different.

Some good news has made primary care and some other physicians happy.

The government’s proposal includes significant changes to reimbursement for all physicians. Most important, the government is boosting rates for the office/outpatient evaluation and management (E/M) codes, combined with simplifying coding requirements.

Specialties that rely heavily on office-based E/M services are delighted at this change. Those include internists, family physicians, neurologists, pulmonologists, dermatologists, and all other specialties that rely heavily on office encounters.

According to the estimates from the Centers for Medicare & Medicaid Services (CMS), endocrinologists and rheumatologists are the big winners, at 17% and 16% projected increases, respectively. The government has been pushing to make this shift in reimbursement from surgeries and procedures to office visits for years. Although some physicians may celebrate the change, others will not.

The reimbursement plan for professional services depends on budget neutrality, meaning that the budget increases need to be counterbalanced by budget declines. Specialties that rely heavily on procedures and surgeries will suffer losses. These corresponding reductions felt by proceduralists and surgeons will counterbalance the good fortune of physicians who rely on office visits for the bulk of their revenue. Radiologists, for example, are projected by CMS to experience a 11% downturn, and cardiac surgeons face a 9% decline.

These consequences are significant. The 2021 shift may be the single biggest transfer of reimbursement in the history of the scale, which was adopted in the early 1990s.

If the change affected only Medicare reimbursement, perhaps it would be less significant. Because the majority of private payers use the government’s scale – the resource-based relative value scale – the impact will reverberate across physicians’ bottom lines. Given the state of many physicians’ finances, driven by the pandemic, this may send some affected physicians into a downward spiral.

The boost to E/M reimbursement – which represents approximately 20% of the overall Medicare payout to physicians each year – puts downward pressure on the professional services conversion factor as well.

For 2021, it is proposed to be $32.2605, representing a decrease of $3.83 from the 2020 conversion factor of $36.0896. The resultant conversion factor – which serves as a multiplier applied to the relative value unit to come up with the payment – effectively reduces payments to physicians across the board by 10.6%. Thus, even those who enjoy the benefits of the new E/M increases will see the potential reimbursement high point cut down.

Before launching into the changes in store for 2021, it’s good to determine whether you are an eligible clinician: You need to have more than $90,000 in Medicare Part B charges per year, see more than 200 Medicare Part B patients per year, and provide 200 or more covered professional services to Part B patients.

The program is voluntary, but there are steep penalties for eligible clinicians who don’t participate. For the 2021 reporting year, a 9% penalty will be imposed on Medicare reimbursement in 2023 in the event of participation failure. You can verify your participation status here; you’ll need your National Provider Identifier to run the search, but it takes only seconds to determine your eligibility.

A 9% penalty is a pretty big hit to your income. With 9% at stake, eligible clinicians need to actively engage in the program. Although there have been changes, the basic four-category system remains the same for the MIPS track, as follows: quality, cost, improvement activities, and promoting interoperability.

The four category weights, used to evaluate performance, are changing in 2021. Cost category weight goes up by 5 percentage points, to be 20% of the clinician’s score, and the quality category goes down by 5 percentage points to contribute 40% to the weight. Promoting interoperability remains 25% of the score, with improvement activities constituting the final 15%.

Other key changes include the following:

• The CMS’s Web interface for submission for quality measures will be shuttered in 2021. Users of this submission method will have to find and use another way to report their quality measures.
• Quality measures will be scored against pre-COVID benchmarks in lieu of comparisons with the 2020 reporting year; 206 quality measures are proposed for 2021, compared with the current list of 219.
• Telehealth will be incorporated in the cost category by updates to the measure specifications for the episode-based and total per capita cost measures.
• A new health information exchange measure is added to the promoting interoperability category, and “incorporating” replaces “reconciling” in the reporting requirement “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”

To avoid the 9% penalty, eligible clinicians must earn 50 points in 2021, up from 45 in the current year. Achieving “exceptional performance” remains at 85 points. This elevated level of engagement allows access to a pot of money Congress set aside for high performers.

Many physicians feel that too much work is required to earn the “paltry” bonuses; even a perfect score of 100 has only resulted in bonuses of 1.88% and 1.68%, respectively, in the past 2 years. That includes the $500 million allocation that Congress set aside; this extra funding to reward exceptional performance is only available for the first 6 years of the law. Although the 2019 scores have been released to participants, CMS has not yet announced the overall national average, but it’s expected to be minimal.

The combination of meager payouts and a diminishing funding mechanism has physicians questioning participation altogether. My recent conversations with physicians who qualify for the program revealed their intention to participate, but only at a level to achieve the minimum threshold of 45 points this year and 50 in 2021. With so little upside, it’s impossible to make a business case to aim for the stars.

Perhaps the biggest change in 2021, however, is that the program is not making the previously planned switch to MIPS Value Pathways (MVPs). MVPs were designed to align the four performance categories around a specialty, medical condition, or patient population.

CMS introduced MVPs by giving an example of diabetes: “Endocrinologist reports same ‘foundation’ of PI [promoting interoperability] and population health measures as all other clinicians but now has a MIPS Value Pathway with measures and activities that focus on diabetes prevention and treatment.” CMS had expected MVPs to launch in 2021 for all program participants; because of the pandemic, CMS announced an extension for at least 1 year. This comes as a relief to physicians who are just trying to keep the lights on given the financial pressures brought on by the pandemic.

MVPs, however, will be incorporated into the MIPS Alternative Payment Model (APM) participation segment. This will affect many physicians because this is the path that accountable care organizations (ACOs) have taken. If you are part of an ACO and you report through it, you’ll see some more changes than your colleagues in 2021.

The good news is that ACOs that participate in MIPS and the Medicare Shared Savings Program will have to report only once to satisfy the requirements for both programs. The construct for this new APM-based program is called the “APM Performance Pathway.” This pathway incorporates six population health–based measures that cross-cut specialties.

CMS is also proposing that telemedicine reimbursement will become permanent. As of now, telemedicine services will only be paid when a public health emergency has been declared. This ability to reimburse physicians for telemedicine would end when the current public health emergency is over. CMS is proposing to extend reimbursement beyond the pandemic, which will benefit all physicians who perform these remote encounters.

The CMS proposal would also make some other requirements easier to achieve. The use of codes 99495 and 99496 – the transitional care management codes – is expanding by reducing several key accompanying-services restrictions. Before the public health emergency, there were constraints related to scope of practice; the proposal would extend the ability of advanced practice providers to order diagnostic tests, even after the public health emergency ends.

Furthermore, the proposal reduces restrictions related to billing for remote physiologic monitoring services and outlines the possibility of a new, higher-paying virtual visit code.

Although the Quality Payment Program will undergo some changes, they are minor. Be aware of the requirement to hit the 50-point mark to avoid the steep penalties, however. Perhaps greater benefit will be achieved through the government’s continued push to refine the reimbursement system. As a result of budget neutrality, however, these changes will boost some physicians while resulting in losses for others.

The government’s proposed changes are not final, and there is a period during which they are accepting comments on the proposal; the final rule will be announced in November.

If you want to wash your hands of this now, apply for the 2020 performance year hardship for the Quality Payment Program. The application is now open and available through December 31, 2020; completing it will release you of any program requirements in 2020 (and avoid that hefty 9% penalty on your 2022 reimbursement).

This way, you won’t have to concern yourself with any of these rules until next year; the government’s extension of this “get out of jail free” card is a welcome relief for physicians who are frustrated by the regulatory burdens despite the pressure exerted by COVID. Spending 15 minutes to complete this form is well worth your time and may eliminate much of your worry.
 

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

Amid all the chaos and problems caused by COVID-19, one might hope that physicians would get a break on their complicated payment-reporting programs.

But that’s not the case: The government recently released the 2021 proposed rule for the Quality Payment Program (QPP), often referred to by its most popular participation track, the Merit-Based Incentive Payment System (MIPS). The program, which launched in 2017, gets annual updates, and this year is no different.

Some good news has made primary care and some other physicians happy.

The government’s proposal includes significant changes to reimbursement for all physicians. Most important, the government is boosting rates for the office/outpatient evaluation and management (E/M) codes, combined with simplifying coding requirements.

Specialties that rely heavily on office-based E/M services are delighted at this change. Those include internists, family physicians, neurologists, pulmonologists, dermatologists, and all other specialties that rely heavily on office encounters.

According to the estimates from the Centers for Medicare & Medicaid Services (CMS), endocrinologists and rheumatologists are the big winners, at 17% and 16% projected increases, respectively. The government has been pushing to make this shift in reimbursement from surgeries and procedures to office visits for years. Although some physicians may celebrate the change, others will not.

The reimbursement plan for professional services depends on budget neutrality, meaning that the budget increases need to be counterbalanced by budget declines. Specialties that rely heavily on procedures and surgeries will suffer losses. These corresponding reductions felt by proceduralists and surgeons will counterbalance the good fortune of physicians who rely on office visits for the bulk of their revenue. Radiologists, for example, are projected by CMS to experience a 11% downturn, and cardiac surgeons face a 9% decline.

These consequences are significant. The 2021 shift may be the single biggest transfer of reimbursement in the history of the scale, which was adopted in the early 1990s.

If the change affected only Medicare reimbursement, perhaps it would be less significant. Because the majority of private payers use the government’s scale – the resource-based relative value scale – the impact will reverberate across physicians’ bottom lines. Given the state of many physicians’ finances, driven by the pandemic, this may send some affected physicians into a downward spiral.

The boost to E/M reimbursement – which represents approximately 20% of the overall Medicare payout to physicians each year – puts downward pressure on the professional services conversion factor as well.

For 2021, it is proposed to be $32.2605, representing a decrease of $3.83 from the 2020 conversion factor of $36.0896. The resultant conversion factor – which serves as a multiplier applied to the relative value unit to come up with the payment – effectively reduces payments to physicians across the board by 10.6%. Thus, even those who enjoy the benefits of the new E/M increases will see the potential reimbursement high point cut down.

Before launching into the changes in store for 2021, it’s good to determine whether you are an eligible clinician: You need to have more than $90,000 in Medicare Part B charges per year, see more than 200 Medicare Part B patients per year, and provide 200 or more covered professional services to Part B patients.

The program is voluntary, but there are steep penalties for eligible clinicians who don’t participate. For the 2021 reporting year, a 9% penalty will be imposed on Medicare reimbursement in 2023 in the event of participation failure. You can verify your participation status here; you’ll need your National Provider Identifier to run the search, but it takes only seconds to determine your eligibility.

A 9% penalty is a pretty big hit to your income. With 9% at stake, eligible clinicians need to actively engage in the program. Although there have been changes, the basic four-category system remains the same for the MIPS track, as follows: quality, cost, improvement activities, and promoting interoperability.

The four category weights, used to evaluate performance, are changing in 2021. Cost category weight goes up by 5 percentage points, to be 20% of the clinician’s score, and the quality category goes down by 5 percentage points to contribute 40% to the weight. Promoting interoperability remains 25% of the score, with improvement activities constituting the final 15%.

Other key changes include the following:

• The CMS’s Web interface for submission for quality measures will be shuttered in 2021. Users of this submission method will have to find and use another way to report their quality measures.
• Quality measures will be scored against pre-COVID benchmarks in lieu of comparisons with the 2020 reporting year; 206 quality measures are proposed for 2021, compared with the current list of 219.
• Telehealth will be incorporated in the cost category by updates to the measure specifications for the episode-based and total per capita cost measures.
• A new health information exchange measure is added to the promoting interoperability category, and “incorporating” replaces “reconciling” in the reporting requirement “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”

To avoid the 9% penalty, eligible clinicians must earn 50 points in 2021, up from 45 in the current year. Achieving “exceptional performance” remains at 85 points. This elevated level of engagement allows access to a pot of money Congress set aside for high performers.

Many physicians feel that too much work is required to earn the “paltry” bonuses; even a perfect score of 100 has only resulted in bonuses of 1.88% and 1.68%, respectively, in the past 2 years. That includes the $500 million allocation that Congress set aside; this extra funding to reward exceptional performance is only available for the first 6 years of the law. Although the 2019 scores have been released to participants, CMS has not yet announced the overall national average, but it’s expected to be minimal.

The combination of meager payouts and a diminishing funding mechanism has physicians questioning participation altogether. My recent conversations with physicians who qualify for the program revealed their intention to participate, but only at a level to achieve the minimum threshold of 45 points this year and 50 in 2021. With so little upside, it’s impossible to make a business case to aim for the stars.

Perhaps the biggest change in 2021, however, is that the program is not making the previously planned switch to MIPS Value Pathways (MVPs). MVPs were designed to align the four performance categories around a specialty, medical condition, or patient population.

CMS introduced MVPs by giving an example of diabetes: “Endocrinologist reports same ‘foundation’ of PI [promoting interoperability] and population health measures as all other clinicians but now has a MIPS Value Pathway with measures and activities that focus on diabetes prevention and treatment.” CMS had expected MVPs to launch in 2021 for all program participants; because of the pandemic, CMS announced an extension for at least 1 year. This comes as a relief to physicians who are just trying to keep the lights on given the financial pressures brought on by the pandemic.

MVPs, however, will be incorporated into the MIPS Alternative Payment Model (APM) participation segment. This will affect many physicians because this is the path that accountable care organizations (ACOs) have taken. If you are part of an ACO and you report through it, you’ll see some more changes than your colleagues in 2021.

The good news is that ACOs that participate in MIPS and the Medicare Shared Savings Program will have to report only once to satisfy the requirements for both programs. The construct for this new APM-based program is called the “APM Performance Pathway.” This pathway incorporates six population health–based measures that cross-cut specialties.

CMS is also proposing that telemedicine reimbursement will become permanent. As of now, telemedicine services will only be paid when a public health emergency has been declared. This ability to reimburse physicians for telemedicine would end when the current public health emergency is over. CMS is proposing to extend reimbursement beyond the pandemic, which will benefit all physicians who perform these remote encounters.

The CMS proposal would also make some other requirements easier to achieve. The use of codes 99495 and 99496 – the transitional care management codes – is expanding by reducing several key accompanying-services restrictions. Before the public health emergency, there were constraints related to scope of practice; the proposal would extend the ability of advanced practice providers to order diagnostic tests, even after the public health emergency ends.

Furthermore, the proposal reduces restrictions related to billing for remote physiologic monitoring services and outlines the possibility of a new, higher-paying virtual visit code.

Although the Quality Payment Program will undergo some changes, they are minor. Be aware of the requirement to hit the 50-point mark to avoid the steep penalties, however. Perhaps greater benefit will be achieved through the government’s continued push to refine the reimbursement system. As a result of budget neutrality, however, these changes will boost some physicians while resulting in losses for others.

The government’s proposed changes are not final, and there is a period during which they are accepting comments on the proposal; the final rule will be announced in November.

If you want to wash your hands of this now, apply for the 2020 performance year hardship for the Quality Payment Program. The application is now open and available through December 31, 2020; completing it will release you of any program requirements in 2020 (and avoid that hefty 9% penalty on your 2022 reimbursement).

This way, you won’t have to concern yourself with any of these rules until next year; the government’s extension of this “get out of jail free” card is a welcome relief for physicians who are frustrated by the regulatory burdens despite the pressure exerted by COVID. Spending 15 minutes to complete this form is well worth your time and may eliminate much of your worry.
 

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

Amid all the chaos and problems caused by COVID-19, one might hope that physicians would get a break on their complicated payment-reporting programs.

But that’s not the case: The government recently released the 2021 proposed rule for the Quality Payment Program (QPP), often referred to by its most popular participation track, the Merit-Based Incentive Payment System (MIPS). The program, which launched in 2017, gets annual updates, and this year is no different.

Some good news has made primary care and some other physicians happy.

The government’s proposal includes significant changes to reimbursement for all physicians. Most important, the government is boosting rates for the office/outpatient evaluation and management (E/M) codes, combined with simplifying coding requirements.

Specialties that rely heavily on office-based E/M services are delighted at this change. Those include internists, family physicians, neurologists, pulmonologists, dermatologists, and all other specialties that rely heavily on office encounters.

According to the estimates from the Centers for Medicare & Medicaid Services (CMS), endocrinologists and rheumatologists are the big winners, at 17% and 16% projected increases, respectively. The government has been pushing to make this shift in reimbursement from surgeries and procedures to office visits for years. Although some physicians may celebrate the change, others will not.

The reimbursement plan for professional services depends on budget neutrality, meaning that the budget increases need to be counterbalanced by budget declines. Specialties that rely heavily on procedures and surgeries will suffer losses. These corresponding reductions felt by proceduralists and surgeons will counterbalance the good fortune of physicians who rely on office visits for the bulk of their revenue. Radiologists, for example, are projected by CMS to experience a 11% downturn, and cardiac surgeons face a 9% decline.

These consequences are significant. The 2021 shift may be the single biggest transfer of reimbursement in the history of the scale, which was adopted in the early 1990s.

If the change affected only Medicare reimbursement, perhaps it would be less significant. Because the majority of private payers use the government’s scale – the resource-based relative value scale – the impact will reverberate across physicians’ bottom lines. Given the state of many physicians’ finances, driven by the pandemic, this may send some affected physicians into a downward spiral.

The boost to E/M reimbursement – which represents approximately 20% of the overall Medicare payout to physicians each year – puts downward pressure on the professional services conversion factor as well.

For 2021, it is proposed to be $32.2605, representing a decrease of $3.83 from the 2020 conversion factor of $36.0896. The resultant conversion factor – which serves as a multiplier applied to the relative value unit to come up with the payment – effectively reduces payments to physicians across the board by 10.6%. Thus, even those who enjoy the benefits of the new E/M increases will see the potential reimbursement high point cut down.

Before launching into the changes in store for 2021, it’s good to determine whether you are an eligible clinician: You need to have more than $90,000 in Medicare Part B charges per year, see more than 200 Medicare Part B patients per year, and provide 200 or more covered professional services to Part B patients.

The program is voluntary, but there are steep penalties for eligible clinicians who don’t participate. For the 2021 reporting year, a 9% penalty will be imposed on Medicare reimbursement in 2023 in the event of participation failure. You can verify your participation status here; you’ll need your National Provider Identifier to run the search, but it takes only seconds to determine your eligibility.

A 9% penalty is a pretty big hit to your income. With 9% at stake, eligible clinicians need to actively engage in the program. Although there have been changes, the basic four-category system remains the same for the MIPS track, as follows: quality, cost, improvement activities, and promoting interoperability.

The four category weights, used to evaluate performance, are changing in 2021. Cost category weight goes up by 5 percentage points, to be 20% of the clinician’s score, and the quality category goes down by 5 percentage points to contribute 40% to the weight. Promoting interoperability remains 25% of the score, with improvement activities constituting the final 15%.

Other key changes include the following:

• The CMS’s Web interface for submission for quality measures will be shuttered in 2021. Users of this submission method will have to find and use another way to report their quality measures.
• Quality measures will be scored against pre-COVID benchmarks in lieu of comparisons with the 2020 reporting year; 206 quality measures are proposed for 2021, compared with the current list of 219.
• Telehealth will be incorporated in the cost category by updates to the measure specifications for the episode-based and total per capita cost measures.
• A new health information exchange measure is added to the promoting interoperability category, and “incorporating” replaces “reconciling” in the reporting requirement “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”

To avoid the 9% penalty, eligible clinicians must earn 50 points in 2021, up from 45 in the current year. Achieving “exceptional performance” remains at 85 points. This elevated level of engagement allows access to a pot of money Congress set aside for high performers.

Many physicians feel that too much work is required to earn the “paltry” bonuses; even a perfect score of 100 has only resulted in bonuses of 1.88% and 1.68%, respectively, in the past 2 years. That includes the $500 million allocation that Congress set aside; this extra funding to reward exceptional performance is only available for the first 6 years of the law. Although the 2019 scores have been released to participants, CMS has not yet announced the overall national average, but it’s expected to be minimal.

The combination of meager payouts and a diminishing funding mechanism has physicians questioning participation altogether. My recent conversations with physicians who qualify for the program revealed their intention to participate, but only at a level to achieve the minimum threshold of 45 points this year and 50 in 2021. With so little upside, it’s impossible to make a business case to aim for the stars.

Perhaps the biggest change in 2021, however, is that the program is not making the previously planned switch to MIPS Value Pathways (MVPs). MVPs were designed to align the four performance categories around a specialty, medical condition, or patient population.

CMS introduced MVPs by giving an example of diabetes: “Endocrinologist reports same ‘foundation’ of PI [promoting interoperability] and population health measures as all other clinicians but now has a MIPS Value Pathway with measures and activities that focus on diabetes prevention and treatment.” CMS had expected MVPs to launch in 2021 for all program participants; because of the pandemic, CMS announced an extension for at least 1 year. This comes as a relief to physicians who are just trying to keep the lights on given the financial pressures brought on by the pandemic.

MVPs, however, will be incorporated into the MIPS Alternative Payment Model (APM) participation segment. This will affect many physicians because this is the path that accountable care organizations (ACOs) have taken. If you are part of an ACO and you report through it, you’ll see some more changes than your colleagues in 2021.

The good news is that ACOs that participate in MIPS and the Medicare Shared Savings Program will have to report only once to satisfy the requirements for both programs. The construct for this new APM-based program is called the “APM Performance Pathway.” This pathway incorporates six population health–based measures that cross-cut specialties.

CMS is also proposing that telemedicine reimbursement will become permanent. As of now, telemedicine services will only be paid when a public health emergency has been declared. This ability to reimburse physicians for telemedicine would end when the current public health emergency is over. CMS is proposing to extend reimbursement beyond the pandemic, which will benefit all physicians who perform these remote encounters.

The CMS proposal would also make some other requirements easier to achieve. The use of codes 99495 and 99496 – the transitional care management codes – is expanding by reducing several key accompanying-services restrictions. Before the public health emergency, there were constraints related to scope of practice; the proposal would extend the ability of advanced practice providers to order diagnostic tests, even after the public health emergency ends.

Furthermore, the proposal reduces restrictions related to billing for remote physiologic monitoring services and outlines the possibility of a new, higher-paying virtual visit code.

Although the Quality Payment Program will undergo some changes, they are minor. Be aware of the requirement to hit the 50-point mark to avoid the steep penalties, however. Perhaps greater benefit will be achieved through the government’s continued push to refine the reimbursement system. As a result of budget neutrality, however, these changes will boost some physicians while resulting in losses for others.

The government’s proposed changes are not final, and there is a period during which they are accepting comments on the proposal; the final rule will be announced in November.

If you want to wash your hands of this now, apply for the 2020 performance year hardship for the Quality Payment Program. The application is now open and available through December 31, 2020; completing it will release you of any program requirements in 2020 (and avoid that hefty 9% penalty on your 2022 reimbursement).

This way, you won’t have to concern yourself with any of these rules until next year; the government’s extension of this “get out of jail free” card is a welcome relief for physicians who are frustrated by the regulatory burdens despite the pressure exerted by COVID. Spending 15 minutes to complete this form is well worth your time and may eliminate much of your worry.
 

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

In patients with completely resected non–small cell lung cancer and proven N2 disease, postoperative radiotherapy (PORT) provided no significant improvement in disease-free survival (DFS) at 3 years, according to a phase 3 trial.

Investigator Cécile Le Péchoux, MD, a radiation oncologist from Institut Gustave Roussy in Paris, presented the results of the Lung ART trial at the European Society for Medical Oncology Virtual Congress 2020.

The results resolve what ESMO commentator Rafal Dziadziuszko, MD, PhD, of Medical University of Gdansk (Poland), called “perhaps the longest ongoing debate in thoracic oncology,” on whether or not to irradiate patients with mediastinal lymph node involvement after surgery.

Dr. Dziadziuszko noted that some past studies have suggested PORT may provide improved local control and a survival benefit, but other studies have shown no survival benefit and evidence of harm with PORT.

“So here is an academic study with the answer,” Dr. Dziadziuszko said.
 

Study details

The intention-to-treat population of Lung ART included 252 patients randomized to receive 5.5 weeks of PORT (54 Gy) and 249 patients randomized to the control arm without PORT.

The patients’ median age was 61 years, 66% were men, and adenocarcinoma was the predominant histology (76% of patients in the control arm and 70% in the PORT arm). All patients had received adjuvant or neoadjuvant chemotherapy.

The median follow-up was 4.8 years. The 3-year DFS rate was 47.1% in the PORT arm and 43.8% in the control arm (hazard ratio, 0.85; 95% confidence interval, 0.67-1.07, P = .16). The median DFS was 30.5 months with PORT and 22.8 months in the control group. As for DFS components, the rate for death as a first event was 14.6% in the PORT arm and 5.3% among controls.

The mediastinal relapse rate was higher among controls, at 46.1% versus 25.0% with PORT.

The 3-year overall survival rate was 66.5% among patients in the PORT arm and 68.5% in the control arm.

At least one grade 3-4 toxicity was reported in 23.7% of the PORT group and in 15.0% of controls. The grade 3-4 cardiopulmonary toxicity rate of 10.8% in the PORT arm and 4.9% in the control arm needs to be further explored, Dr. Le Péchoux said.
 

Applying the results to practice

In response to a question as to which patients might benefit from PORT, Dr. Le Péchoux pointed out that, among patients who have nodes in the inferior part of the mediastinum closer to the heart, PORT might be more toxic.

“For the moment, we did not see anything that would give us a clue,” Dr. Le Péchoux said. “We have a lot to investigate.”

Further analyses looking at patterns of failure, predictive factors of efficacy and toxicity, quality of radiotherapy, and quality of surgery are planned, she added.

Dr. Le Péchoux concluded: “Conformal PORT cannot be recommended as standard of care in all completely resected stage IIIAN2 [non–small cell lung cancer] patients.”

Dr. Dziadziuszko commented further: “For my practice, this is a clear message that routine PORT should not be used in these patients. We are looking for more effective systemic therapies.”

He added that “over 50% 5-year survival in these patients is a great result, and is made possible by modern staging and modern surgery.”

The Lung ART study was sponsored by Gustave Roussy and supported by the French National Cancer Institute, French Health Ministry, and a Cancer Research UK grant. Dr. Le Péchoux and Dr. Dziadziuszko reported no conflicts of interest related to the presentation.

SOURCE: Le Péchoux C et al. ESMO 2020, Abstract LBA3_PR.

In patients with completely resected non–small cell lung cancer and proven N2 disease, postoperative radiotherapy (PORT) provided no significant improvement in disease-free survival (DFS) at 3 years, according to a phase 3 trial.

Investigator Cécile Le Péchoux, MD, a radiation oncologist from Institut Gustave Roussy in Paris, presented the results of the Lung ART trial at the European Society for Medical Oncology Virtual Congress 2020.

The results resolve what ESMO commentator Rafal Dziadziuszko, MD, PhD, of Medical University of Gdansk (Poland), called “perhaps the longest ongoing debate in thoracic oncology,” on whether or not to irradiate patients with mediastinal lymph node involvement after surgery.

Dr. Dziadziuszko noted that some past studies have suggested PORT may provide improved local control and a survival benefit, but other studies have shown no survival benefit and evidence of harm with PORT.

“So here is an academic study with the answer,” Dr. Dziadziuszko said.
 

Study details

The intention-to-treat population of Lung ART included 252 patients randomized to receive 5.5 weeks of PORT (54 Gy) and 249 patients randomized to the control arm without PORT.

The patients’ median age was 61 years, 66% were men, and adenocarcinoma was the predominant histology (76% of patients in the control arm and 70% in the PORT arm). All patients had received adjuvant or neoadjuvant chemotherapy.

The median follow-up was 4.8 years. The 3-year DFS rate was 47.1% in the PORT arm and 43.8% in the control arm (hazard ratio, 0.85; 95% confidence interval, 0.67-1.07, P = .16). The median DFS was 30.5 months with PORT and 22.8 months in the control group. As for DFS components, the rate for death as a first event was 14.6% in the PORT arm and 5.3% among controls.

The mediastinal relapse rate was higher among controls, at 46.1% versus 25.0% with PORT.

The 3-year overall survival rate was 66.5% among patients in the PORT arm and 68.5% in the control arm.

At least one grade 3-4 toxicity was reported in 23.7% of the PORT group and in 15.0% of controls. The grade 3-4 cardiopulmonary toxicity rate of 10.8% in the PORT arm and 4.9% in the control arm needs to be further explored, Dr. Le Péchoux said.
 

Applying the results to practice

In response to a question as to which patients might benefit from PORT, Dr. Le Péchoux pointed out that, among patients who have nodes in the inferior part of the mediastinum closer to the heart, PORT might be more toxic.

“For the moment, we did not see anything that would give us a clue,” Dr. Le Péchoux said. “We have a lot to investigate.”

Further analyses looking at patterns of failure, predictive factors of efficacy and toxicity, quality of radiotherapy, and quality of surgery are planned, she added.

Dr. Le Péchoux concluded: “Conformal PORT cannot be recommended as standard of care in all completely resected stage IIIAN2 [non–small cell lung cancer] patients.”

Dr. Dziadziuszko commented further: “For my practice, this is a clear message that routine PORT should not be used in these patients. We are looking for more effective systemic therapies.”

He added that “over 50% 5-year survival in these patients is a great result, and is made possible by modern staging and modern surgery.”

The Lung ART study was sponsored by Gustave Roussy and supported by the French National Cancer Institute, French Health Ministry, and a Cancer Research UK grant. Dr. Le Péchoux and Dr. Dziadziuszko reported no conflicts of interest related to the presentation.

SOURCE: Le Péchoux C et al. ESMO 2020, Abstract LBA3_PR.

In patients with completely resected non–small cell lung cancer and proven N2 disease, postoperative radiotherapy (PORT) provided no significant improvement in disease-free survival (DFS) at 3 years, according to a phase 3 trial.

Investigator Cécile Le Péchoux, MD, a radiation oncologist from Institut Gustave Roussy in Paris, presented the results of the Lung ART trial at the European Society for Medical Oncology Virtual Congress 2020.

The results resolve what ESMO commentator Rafal Dziadziuszko, MD, PhD, of Medical University of Gdansk (Poland), called “perhaps the longest ongoing debate in thoracic oncology,” on whether or not to irradiate patients with mediastinal lymph node involvement after surgery.

Dr. Dziadziuszko noted that some past studies have suggested PORT may provide improved local control and a survival benefit, but other studies have shown no survival benefit and evidence of harm with PORT.

“So here is an academic study with the answer,” Dr. Dziadziuszko said.
 

Study details

The intention-to-treat population of Lung ART included 252 patients randomized to receive 5.5 weeks of PORT (54 Gy) and 249 patients randomized to the control arm without PORT.

The patients’ median age was 61 years, 66% were men, and adenocarcinoma was the predominant histology (76% of patients in the control arm and 70% in the PORT arm). All patients had received adjuvant or neoadjuvant chemotherapy.

The median follow-up was 4.8 years. The 3-year DFS rate was 47.1% in the PORT arm and 43.8% in the control arm (hazard ratio, 0.85; 95% confidence interval, 0.67-1.07, P = .16). The median DFS was 30.5 months with PORT and 22.8 months in the control group. As for DFS components, the rate for death as a first event was 14.6% in the PORT arm and 5.3% among controls.

The mediastinal relapse rate was higher among controls, at 46.1% versus 25.0% with PORT.

The 3-year overall survival rate was 66.5% among patients in the PORT arm and 68.5% in the control arm.

At least one grade 3-4 toxicity was reported in 23.7% of the PORT group and in 15.0% of controls. The grade 3-4 cardiopulmonary toxicity rate of 10.8% in the PORT arm and 4.9% in the control arm needs to be further explored, Dr. Le Péchoux said.
 

Applying the results to practice

In response to a question as to which patients might benefit from PORT, Dr. Le Péchoux pointed out that, among patients who have nodes in the inferior part of the mediastinum closer to the heart, PORT might be more toxic.

“For the moment, we did not see anything that would give us a clue,” Dr. Le Péchoux said. “We have a lot to investigate.”

Further analyses looking at patterns of failure, predictive factors of efficacy and toxicity, quality of radiotherapy, and quality of surgery are planned, she added.

Dr. Le Péchoux concluded: “Conformal PORT cannot be recommended as standard of care in all completely resected stage IIIAN2 [non–small cell lung cancer] patients.”

Dr. Dziadziuszko commented further: “For my practice, this is a clear message that routine PORT should not be used in these patients. We are looking for more effective systemic therapies.”

He added that “over 50% 5-year survival in these patients is a great result, and is made possible by modern staging and modern surgery.”

The Lung ART study was sponsored by Gustave Roussy and supported by the French National Cancer Institute, French Health Ministry, and a Cancer Research UK grant. Dr. Le Péchoux and Dr. Dziadziuszko reported no conflicts of interest related to the presentation.

SOURCE: Le Péchoux C et al. ESMO 2020, Abstract LBA3_PR.

An international survey provides new insights into how COVID-19 has affected, and may continue to affect, the field of oncology.

The survey showed that “COVID-19 has had a major impact on the organization of patient care, on the well-being of caregivers, on continued medical education, and on clinical trial activities in oncology,” stated Guy Jerusalem, MD, PhD, of Centre Hospitalier Universitaire de Liège (Belgium).

Dr. Jerusalem presented these findings at the European Society for Medical Oncology Virtual Congress 2020.

The survey was distributed by 20 oncologists from 10 of the countries most affected by COVID-19. Responses were obtained from 109 oncologists representing centers in 18 countries. The responses were recorded between June 17 and July 14, 2020.

The survey consisted of 95 items intended to evaluate the impact of COVID-19 on the organization of oncologic care. Questions encompassed the capacity and service offered at each center, the magnitude of COVID-19–based care interruptions and the reasons for them, the ensuing challenges faced, interventions implemented, and the estimated harms to patients during the pandemic.

The 109 oncologists surveyed had a median of 20 years of oncology experience. A majority of respondents were men (61.5%), and the median age was 48.5 years.

The respondents had worked predominantly (62.4%) at academic hospitals, with 29.6% at community hospitals. Most respondents worked at general hospitals with an oncology unit (66.1%) rather than a specialized separate cancer center (32.1%).

The most common specialty was breast cancer (60.6%), followed by gastrointestinal cancer (10.1%), urogenital cancer (9.2%), and lung cancer (8.3%).
 

Impact on treatment

The treatment modalities affected by the pandemic – through cancellations or delays in more than 10% of patients – included surgery (in 34% of centers), chemotherapy (22%), radiotherapy (13.7%), checkpoint inhibitor therapy (9.1%), monoclonal antibodies (9%), and oral targeted therapy (3.7%).

Among oncologists treating breast cancer, cancellations/delays in more than 10% of patients were reported for everolimus (18%), CDK4/6 inhibitors (8.9%), and endocrine therapy (2.2%).

Overall, 34.8% of respondents reported increased use of granulocyte colony–stimulating factor, and 6.4% reported increased use of erythropoietin.

On the other hand, 11.1% of respondents reported a decrease in the use of double immunotherapy, and 21.9% reported decreased use of corticosteroids.

Not only can the immunosuppressive effects of steroid use increase infection risks, Dr. Jerusalem noted, fever suppression can lead to a delayed diagnosis of COVID-19.

“To circumvent potential higher infection risks or greater disease severity, we use lower doses of steroids, but this is not based on studies,” he said.

“Previous exposure to steroids or being on steroids at the time of COVID-19 infection is a detrimental factor for complications and mortality,” commented ESMO President Solange Peters, MD, PhD, of Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland.

Frontline Medical News

Dr. Peters noted that the observation was based on lung cancer registry findings. Furthermore, because data from smaller outbreaks of other coronavirus infections suggested worse prognosis and increased mortality, steroid use was already feared in the very early days of the COVID-19 pandemic.

Lastly, earlier cessation of palliative treatment was observed in 32.1% of centers, and 64.2% of respondents agreed that undertreatment because of COVID-19 is a major concern.

Dr. Jerusalem noted that the survey data do not explain the early cessation of palliative treatment. “I suspect that many patients died at home rather than alone in institutions because it was the only way they could die with their families around them.”
 

Telehealth, meetings, and trials

The survey also revealed rationales for the use of teleconsultation, including follow-up (94.5%), oral therapy (92.7%), immunotherapy (57.8%), and chemotherapy (55%).

Most respondents reported more frequent use of virtual meetings for continuing medical education (94%), oncologic team meetings (92%), and tumor boards (82%).

While about 82% of respondents said they were likely to continue the use of telemedicine, 45% said virtual conferences are not an acceptable alternative to live international conferences such as ESMO, Dr. Jerusalem said.

Finally, nearly three-quarters of respondents (72.5%) said all clinical trial activities are or will soon be activated, or never stopped, at their centers. On the other hand, 27.5% of respondents reported that their centers had major protocol violations or deviations, and 37% of respondents said they expect significant reductions in clinical trial activities this year.

Dr. Jerusalem concluded that COVID-19 is having a major, long-term impact on the organization of patient care, caregivers, continued medical education, and clinical trial activities in oncology.

He cautioned that “the risk of a delayed diagnosis of new cancers and economic consequences of COVID-19 on access to health care and cancer treatments have to be carefully evaluated.”

This research was funded by Fondation Léon Fredericq. Dr. Jerusalem disclosed relationships with Novartis, Roche, Lilly, Pfizer, Amgen, Bristol-Myers Squibb, AstraZeneca, Daiichi Sankyo, AbbVie, MedImmune, and Merck. Dr. Peters disclosed relationships with AbbVie, Amgen, AstraZeneca, and many other companies.

SOURCE: Jerusalem G et al. ESMO 2020, Abstract LBA76.

An international survey provides new insights into how COVID-19 has affected, and may continue to affect, the field of oncology.

The survey showed that “COVID-19 has had a major impact on the organization of patient care, on the well-being of caregivers, on continued medical education, and on clinical trial activities in oncology,” stated Guy Jerusalem, MD, PhD, of Centre Hospitalier Universitaire de Liège (Belgium).

Dr. Jerusalem presented these findings at the European Society for Medical Oncology Virtual Congress 2020.

The survey was distributed by 20 oncologists from 10 of the countries most affected by COVID-19. Responses were obtained from 109 oncologists representing centers in 18 countries. The responses were recorded between June 17 and July 14, 2020.

The survey consisted of 95 items intended to evaluate the impact of COVID-19 on the organization of oncologic care. Questions encompassed the capacity and service offered at each center, the magnitude of COVID-19–based care interruptions and the reasons for them, the ensuing challenges faced, interventions implemented, and the estimated harms to patients during the pandemic.

The 109 oncologists surveyed had a median of 20 years of oncology experience. A majority of respondents were men (61.5%), and the median age was 48.5 years.

The respondents had worked predominantly (62.4%) at academic hospitals, with 29.6% at community hospitals. Most respondents worked at general hospitals with an oncology unit (66.1%) rather than a specialized separate cancer center (32.1%).

The most common specialty was breast cancer (60.6%), followed by gastrointestinal cancer (10.1%), urogenital cancer (9.2%), and lung cancer (8.3%).
 

Impact on treatment

The treatment modalities affected by the pandemic – through cancellations or delays in more than 10% of patients – included surgery (in 34% of centers), chemotherapy (22%), radiotherapy (13.7%), checkpoint inhibitor therapy (9.1%), monoclonal antibodies (9%), and oral targeted therapy (3.7%).

Among oncologists treating breast cancer, cancellations/delays in more than 10% of patients were reported for everolimus (18%), CDK4/6 inhibitors (8.9%), and endocrine therapy (2.2%).

Overall, 34.8% of respondents reported increased use of granulocyte colony–stimulating factor, and 6.4% reported increased use of erythropoietin.

On the other hand, 11.1% of respondents reported a decrease in the use of double immunotherapy, and 21.9% reported decreased use of corticosteroids.

Not only can the immunosuppressive effects of steroid use increase infection risks, Dr. Jerusalem noted, fever suppression can lead to a delayed diagnosis of COVID-19.

“To circumvent potential higher infection risks or greater disease severity, we use lower doses of steroids, but this is not based on studies,” he said.

“Previous exposure to steroids or being on steroids at the time of COVID-19 infection is a detrimental factor for complications and mortality,” commented ESMO President Solange Peters, MD, PhD, of Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland.

Frontline Medical News

Dr. Peters noted that the observation was based on lung cancer registry findings. Furthermore, because data from smaller outbreaks of other coronavirus infections suggested worse prognosis and increased mortality, steroid use was already feared in the very early days of the COVID-19 pandemic.

Lastly, earlier cessation of palliative treatment was observed in 32.1% of centers, and 64.2% of respondents agreed that undertreatment because of COVID-19 is a major concern.

Dr. Jerusalem noted that the survey data do not explain the early cessation of palliative treatment. “I suspect that many patients died at home rather than alone in institutions because it was the only way they could die with their families around them.”
 

Telehealth, meetings, and trials

The survey also revealed rationales for the use of teleconsultation, including follow-up (94.5%), oral therapy (92.7%), immunotherapy (57.8%), and chemotherapy (55%).

Most respondents reported more frequent use of virtual meetings for continuing medical education (94%), oncologic team meetings (92%), and tumor boards (82%).

While about 82% of respondents said they were likely to continue the use of telemedicine, 45% said virtual conferences are not an acceptable alternative to live international conferences such as ESMO, Dr. Jerusalem said.

Finally, nearly three-quarters of respondents (72.5%) said all clinical trial activities are or will soon be activated, or never stopped, at their centers. On the other hand, 27.5% of respondents reported that their centers had major protocol violations or deviations, and 37% of respondents said they expect significant reductions in clinical trial activities this year.

Dr. Jerusalem concluded that COVID-19 is having a major, long-term impact on the organization of patient care, caregivers, continued medical education, and clinical trial activities in oncology.

He cautioned that “the risk of a delayed diagnosis of new cancers and economic consequences of COVID-19 on access to health care and cancer treatments have to be carefully evaluated.”

This research was funded by Fondation Léon Fredericq. Dr. Jerusalem disclosed relationships with Novartis, Roche, Lilly, Pfizer, Amgen, Bristol-Myers Squibb, AstraZeneca, Daiichi Sankyo, AbbVie, MedImmune, and Merck. Dr. Peters disclosed relationships with AbbVie, Amgen, AstraZeneca, and many other companies.

SOURCE: Jerusalem G et al. ESMO 2020, Abstract LBA76.

An international survey provides new insights into how COVID-19 has affected, and may continue to affect, the field of oncology.

The survey showed that “COVID-19 has had a major impact on the organization of patient care, on the well-being of caregivers, on continued medical education, and on clinical trial activities in oncology,” stated Guy Jerusalem, MD, PhD, of Centre Hospitalier Universitaire de Liège (Belgium).

Dr. Jerusalem presented these findings at the European Society for Medical Oncology Virtual Congress 2020.

The survey was distributed by 20 oncologists from 10 of the countries most affected by COVID-19. Responses were obtained from 109 oncologists representing centers in 18 countries. The responses were recorded between June 17 and July 14, 2020.

The survey consisted of 95 items intended to evaluate the impact of COVID-19 on the organization of oncologic care. Questions encompassed the capacity and service offered at each center, the magnitude of COVID-19–based care interruptions and the reasons for them, the ensuing challenges faced, interventions implemented, and the estimated harms to patients during the pandemic.

The 109 oncologists surveyed had a median of 20 years of oncology experience. A majority of respondents were men (61.5%), and the median age was 48.5 years.

The respondents had worked predominantly (62.4%) at academic hospitals, with 29.6% at community hospitals. Most respondents worked at general hospitals with an oncology unit (66.1%) rather than a specialized separate cancer center (32.1%).

The most common specialty was breast cancer (60.6%), followed by gastrointestinal cancer (10.1%), urogenital cancer (9.2%), and lung cancer (8.3%).
 

Impact on treatment

The treatment modalities affected by the pandemic – through cancellations or delays in more than 10% of patients – included surgery (in 34% of centers), chemotherapy (22%), radiotherapy (13.7%), checkpoint inhibitor therapy (9.1%), monoclonal antibodies (9%), and oral targeted therapy (3.7%).

Among oncologists treating breast cancer, cancellations/delays in more than 10% of patients were reported for everolimus (18%), CDK4/6 inhibitors (8.9%), and endocrine therapy (2.2%).

Overall, 34.8% of respondents reported increased use of granulocyte colony–stimulating factor, and 6.4% reported increased use of erythropoietin.

On the other hand, 11.1% of respondents reported a decrease in the use of double immunotherapy, and 21.9% reported decreased use of corticosteroids.

Not only can the immunosuppressive effects of steroid use increase infection risks, Dr. Jerusalem noted, fever suppression can lead to a delayed diagnosis of COVID-19.

“To circumvent potential higher infection risks or greater disease severity, we use lower doses of steroids, but this is not based on studies,” he said.

“Previous exposure to steroids or being on steroids at the time of COVID-19 infection is a detrimental factor for complications and mortality,” commented ESMO President Solange Peters, MD, PhD, of Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland.

Frontline Medical News

Dr. Peters noted that the observation was based on lung cancer registry findings. Furthermore, because data from smaller outbreaks of other coronavirus infections suggested worse prognosis and increased mortality, steroid use was already feared in the very early days of the COVID-19 pandemic.

Lastly, earlier cessation of palliative treatment was observed in 32.1% of centers, and 64.2% of respondents agreed that undertreatment because of COVID-19 is a major concern.

Dr. Jerusalem noted that the survey data do not explain the early cessation of palliative treatment. “I suspect that many patients died at home rather than alone in institutions because it was the only way they could die with their families around them.”
 

Telehealth, meetings, and trials

The survey also revealed rationales for the use of teleconsultation, including follow-up (94.5%), oral therapy (92.7%), immunotherapy (57.8%), and chemotherapy (55%).

Most respondents reported more frequent use of virtual meetings for continuing medical education (94%), oncologic team meetings (92%), and tumor boards (82%).

While about 82% of respondents said they were likely to continue the use of telemedicine, 45% said virtual conferences are not an acceptable alternative to live international conferences such as ESMO, Dr. Jerusalem said.

Finally, nearly three-quarters of respondents (72.5%) said all clinical trial activities are or will soon be activated, or never stopped, at their centers. On the other hand, 27.5% of respondents reported that their centers had major protocol violations or deviations, and 37% of respondents said they expect significant reductions in clinical trial activities this year.

Dr. Jerusalem concluded that COVID-19 is having a major, long-term impact on the organization of patient care, caregivers, continued medical education, and clinical trial activities in oncology.

He cautioned that “the risk of a delayed diagnosis of new cancers and economic consequences of COVID-19 on access to health care and cancer treatments have to be carefully evaluated.”

This research was funded by Fondation Léon Fredericq. Dr. Jerusalem disclosed relationships with Novartis, Roche, Lilly, Pfizer, Amgen, Bristol-Myers Squibb, AstraZeneca, Daiichi Sankyo, AbbVie, MedImmune, and Merck. Dr. Peters disclosed relationships with AbbVie, Amgen, AstraZeneca, and many other companies.

SOURCE: Jerusalem G et al. ESMO 2020, Abstract LBA76.