For injection drug users with hepatitis C virus (HCV) infection, providing treatment opportunities within a local needle exchange program can provide care to more patients and eventually cure more patients, a new study suggests.

The study’s findings help “counteract the implicit belief within the medical community that people who inject drugs can’t or don’t want to engage in health care,” lead author Benjamin Eckhardt, MD, with NYU Grossman School of Medicine, told this news organization.

“By simply focusing on patient accompaniment, limiting stigma, and removing the punitive response for missed appointments, we can effectively engage people who inject drugs in health care and more specifically cure their infection, making significant inroads to HCV elimination,” Dr. Eckhardt said.

The study was published online  in JAMA Internal Medicine.
 

Nonjudgmental, patient-centered approach

Researchers included 165 injection drug users with HCV (mean age, 42 years; 78% men); 82 were randomly allocated to the accessible care intervention and 83 to a usual care control group.

The accessible care model provides HCV treatment within a community-based needle exchange program in a comfortable, nonjudgmental atmosphere, “without fear of shame or stigma that people who inject drugs often experience in mainstream institutions,” the investigators explain.

Control participants were connected to a patient navigator who facilitated referrals to community direct antigen antiviral therapy programs that were not at a syringe service program.

In an intent-to-treat analysis, those enrolled in the accessible care group achieved sustained viral eradication at 12 months at significantly higher rates than those in the control group (67% vs. 23%; P < .001).

Once patients initiated treatment, cure rates were the same in both groups (86%), indicating that the major benefit of the accessible care program was in facilitating treatment, rather than increasing adherence to or response to treatment, the researchers noted.

This is reflected in the fact that the percentage of participants who advanced along the care cascade was significantly higher at each step for the accessible care group than the control group, from referral to an HCV clinician (93% vs. 45%), attendance of the initial HCV clinical visit (87% vs. 37%), completion of baseline laboratory testing (87% vs. 31%), and treatment initiation (78% vs. 27%).
 

Getting to the population in need

“The most surprising aspect of the study was how successful we were at recruiting, engaging, and treating people who inject drugs who lived outside the immediate community where the syringe exchange program was located and had no prior connection to the program,” Dr. Eckhardt said.

“We had numerous individuals travel 45-plus minutes on the subway from the South Bronx, passing four major medical centers with robust hepatitis C treatment programs, to seek care for hepatitis C in a small, dark office – but also an office they’d heard can be trusted – without fear of stigma or preconditions,” Dr. Eckhardt said.

Commenting on the study’s findings, Nancy Reau, MD, section chief of hepatology at Rush Medical College, Chicago, said, “This is another successful example of making therapy accessible to the population who is in need versus trying to move them into a tertiary care model.”

Dr. Reau noted that similar care models exist in the United States but are not always accessible to the population in need.

“The safety and efficacy of current therapy and the simplified care cascade make HCV an appropriate disease for this delivery,” she said, adding that this study “highlights not just the importance of these programs but also the necessity of engaging the medical community, changing policy, and using patient navigators and monetary support/prioritization to provide appropriate HCV management to those who are at high risk for the disease and for transmission.”
 

Accessible care beyond HCV

The coauthors of an accompanying editor’s note point out that the treatment for HCV has improved substantially, but it can be a real challenge to provide treatment to injection drug users because the U.S. health care system is not oriented toward the needs of this population.

“It is not surprising that the accessible care arm achieved a higher rate of viral eradication, as it created a patient-focused experience,” write Asha Choudhury, MD, MPH, with the University of California, San Francisco, and Mitchell Katz, MD, with NYC Health and Hospitals. “Creating inviting and engaging environments is particularly important when caring for patients from stigmatized groups. Having more sites that are accessible and inclusive like this for treating patients will likely increase treatment of hepatitis C.”

In their view, the study raises “two dueling questions: Is this model replicable across the U.S.? And, conversely, why isn’t all medical care offered in friendly, nonjudgmental settings with the intention of meeting patient goals?”

They conclude that the study’s lessons extend beyond this particular population and have implications for the field at large.

“The model is replicable to the extent that health care systems are prepared to provide nonjudgmental supportive care for persons who inject drugs,” they write. “However, all patients would benefit from a health care system that provided more patient-centered environments.”

The study was funded by the National Institute on Drug Abuse. Dr. Eckhardt reports receiving grants from the National Institutes of Health and Gilead during the conduct of the study. Dr. Choudhury, Dr. Katz, and Dr. Reau report no relevant financial relationships.

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

For injection drug users with hepatitis C virus (HCV) infection, providing treatment opportunities within a local needle exchange program can provide care to more patients and eventually cure more patients, a new study suggests.

The study’s findings help “counteract the implicit belief within the medical community that people who inject drugs can’t or don’t want to engage in health care,” lead author Benjamin Eckhardt, MD, with NYU Grossman School of Medicine, told this news organization.

“By simply focusing on patient accompaniment, limiting stigma, and removing the punitive response for missed appointments, we can effectively engage people who inject drugs in health care and more specifically cure their infection, making significant inroads to HCV elimination,” Dr. Eckhardt said.

The study was published online  in JAMA Internal Medicine.
 

Nonjudgmental, patient-centered approach

Researchers included 165 injection drug users with HCV (mean age, 42 years; 78% men); 82 were randomly allocated to the accessible care intervention and 83 to a usual care control group.

The accessible care model provides HCV treatment within a community-based needle exchange program in a comfortable, nonjudgmental atmosphere, “without fear of shame or stigma that people who inject drugs often experience in mainstream institutions,” the investigators explain.

Control participants were connected to a patient navigator who facilitated referrals to community direct antigen antiviral therapy programs that were not at a syringe service program.

In an intent-to-treat analysis, those enrolled in the accessible care group achieved sustained viral eradication at 12 months at significantly higher rates than those in the control group (67% vs. 23%; P < .001).

Once patients initiated treatment, cure rates were the same in both groups (86%), indicating that the major benefit of the accessible care program was in facilitating treatment, rather than increasing adherence to or response to treatment, the researchers noted.

This is reflected in the fact that the percentage of participants who advanced along the care cascade was significantly higher at each step for the accessible care group than the control group, from referral to an HCV clinician (93% vs. 45%), attendance of the initial HCV clinical visit (87% vs. 37%), completion of baseline laboratory testing (87% vs. 31%), and treatment initiation (78% vs. 27%).
 

Getting to the population in need

“The most surprising aspect of the study was how successful we were at recruiting, engaging, and treating people who inject drugs who lived outside the immediate community where the syringe exchange program was located and had no prior connection to the program,” Dr. Eckhardt said.

“We had numerous individuals travel 45-plus minutes on the subway from the South Bronx, passing four major medical centers with robust hepatitis C treatment programs, to seek care for hepatitis C in a small, dark office – but also an office they’d heard can be trusted – without fear of stigma or preconditions,” Dr. Eckhardt said.

Commenting on the study’s findings, Nancy Reau, MD, section chief of hepatology at Rush Medical College, Chicago, said, “This is another successful example of making therapy accessible to the population who is in need versus trying to move them into a tertiary care model.”

Dr. Reau noted that similar care models exist in the United States but are not always accessible to the population in need.

“The safety and efficacy of current therapy and the simplified care cascade make HCV an appropriate disease for this delivery,” she said, adding that this study “highlights not just the importance of these programs but also the necessity of engaging the medical community, changing policy, and using patient navigators and monetary support/prioritization to provide appropriate HCV management to those who are at high risk for the disease and for transmission.”
 

Accessible care beyond HCV

The coauthors of an accompanying editor’s note point out that the treatment for HCV has improved substantially, but it can be a real challenge to provide treatment to injection drug users because the U.S. health care system is not oriented toward the needs of this population.

“It is not surprising that the accessible care arm achieved a higher rate of viral eradication, as it created a patient-focused experience,” write Asha Choudhury, MD, MPH, with the University of California, San Francisco, and Mitchell Katz, MD, with NYC Health and Hospitals. “Creating inviting and engaging environments is particularly important when caring for patients from stigmatized groups. Having more sites that are accessible and inclusive like this for treating patients will likely increase treatment of hepatitis C.”

In their view, the study raises “two dueling questions: Is this model replicable across the U.S.? And, conversely, why isn’t all medical care offered in friendly, nonjudgmental settings with the intention of meeting patient goals?”

They conclude that the study’s lessons extend beyond this particular population and have implications for the field at large.

“The model is replicable to the extent that health care systems are prepared to provide nonjudgmental supportive care for persons who inject drugs,” they write. “However, all patients would benefit from a health care system that provided more patient-centered environments.”

The study was funded by the National Institute on Drug Abuse. Dr. Eckhardt reports receiving grants from the National Institutes of Health and Gilead during the conduct of the study. Dr. Choudhury, Dr. Katz, and Dr. Reau report no relevant financial relationships.

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

For injection drug users with hepatitis C virus (HCV) infection, providing treatment opportunities within a local needle exchange program can provide care to more patients and eventually cure more patients, a new study suggests.

The study’s findings help “counteract the implicit belief within the medical community that people who inject drugs can’t or don’t want to engage in health care,” lead author Benjamin Eckhardt, MD, with NYU Grossman School of Medicine, told this news organization.

“By simply focusing on patient accompaniment, limiting stigma, and removing the punitive response for missed appointments, we can effectively engage people who inject drugs in health care and more specifically cure their infection, making significant inroads to HCV elimination,” Dr. Eckhardt said.

The study was published online  in JAMA Internal Medicine.
 

Nonjudgmental, patient-centered approach

Researchers included 165 injection drug users with HCV (mean age, 42 years; 78% men); 82 were randomly allocated to the accessible care intervention and 83 to a usual care control group.

The accessible care model provides HCV treatment within a community-based needle exchange program in a comfortable, nonjudgmental atmosphere, “without fear of shame or stigma that people who inject drugs often experience in mainstream institutions,” the investigators explain.

Control participants were connected to a patient navigator who facilitated referrals to community direct antigen antiviral therapy programs that were not at a syringe service program.

In an intent-to-treat analysis, those enrolled in the accessible care group achieved sustained viral eradication at 12 months at significantly higher rates than those in the control group (67% vs. 23%; P < .001).

Once patients initiated treatment, cure rates were the same in both groups (86%), indicating that the major benefit of the accessible care program was in facilitating treatment, rather than increasing adherence to or response to treatment, the researchers noted.

This is reflected in the fact that the percentage of participants who advanced along the care cascade was significantly higher at each step for the accessible care group than the control group, from referral to an HCV clinician (93% vs. 45%), attendance of the initial HCV clinical visit (87% vs. 37%), completion of baseline laboratory testing (87% vs. 31%), and treatment initiation (78% vs. 27%).
 

Getting to the population in need

“The most surprising aspect of the study was how successful we were at recruiting, engaging, and treating people who inject drugs who lived outside the immediate community where the syringe exchange program was located and had no prior connection to the program,” Dr. Eckhardt said.

“We had numerous individuals travel 45-plus minutes on the subway from the South Bronx, passing four major medical centers with robust hepatitis C treatment programs, to seek care for hepatitis C in a small, dark office – but also an office they’d heard can be trusted – without fear of stigma or preconditions,” Dr. Eckhardt said.

Commenting on the study’s findings, Nancy Reau, MD, section chief of hepatology at Rush Medical College, Chicago, said, “This is another successful example of making therapy accessible to the population who is in need versus trying to move them into a tertiary care model.”

Dr. Reau noted that similar care models exist in the United States but are not always accessible to the population in need.

“The safety and efficacy of current therapy and the simplified care cascade make HCV an appropriate disease for this delivery,” she said, adding that this study “highlights not just the importance of these programs but also the necessity of engaging the medical community, changing policy, and using patient navigators and monetary support/prioritization to provide appropriate HCV management to those who are at high risk for the disease and for transmission.”
 

Accessible care beyond HCV

The coauthors of an accompanying editor’s note point out that the treatment for HCV has improved substantially, but it can be a real challenge to provide treatment to injection drug users because the U.S. health care system is not oriented toward the needs of this population.

“It is not surprising that the accessible care arm achieved a higher rate of viral eradication, as it created a patient-focused experience,” write Asha Choudhury, MD, MPH, with the University of California, San Francisco, and Mitchell Katz, MD, with NYC Health and Hospitals. “Creating inviting and engaging environments is particularly important when caring for patients from stigmatized groups. Having more sites that are accessible and inclusive like this for treating patients will likely increase treatment of hepatitis C.”

In their view, the study raises “two dueling questions: Is this model replicable across the U.S.? And, conversely, why isn’t all medical care offered in friendly, nonjudgmental settings with the intention of meeting patient goals?”

They conclude that the study’s lessons extend beyond this particular population and have implications for the field at large.

“The model is replicable to the extent that health care systems are prepared to provide nonjudgmental supportive care for persons who inject drugs,” they write. “However, all patients would benefit from a health care system that provided more patient-centered environments.”

The study was funded by the National Institute on Drug Abuse. Dr. Eckhardt reports receiving grants from the National Institutes of Health and Gilead during the conduct of the study. Dr. Choudhury, Dr. Katz, and Dr. Reau report no relevant financial relationships.

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

A 12-week hypocaloric diet provided suitable control of joint disease activity in patients with psoriatic arthritis (PsA), regardless of weight loss, Brazilian researchers found.

Earlier research has reported that weight loss improves the symptoms of PsA.

Improvement in the Brazilian DIETA study was linked to both better eating patterns and better quality of diet, and while omega-3 supplementation caused relevant body composition changes, it did not improve disease activity, according to Beatriz F. Leite of the division of rheumatology at the Federal University of São Paulo and colleagues.

“The DIETA trial, a nonpharmacologic approach, is an inexpensive, suitable, and efficient approach that could be combined with standardized drug therapy,” the investigators wrote online in Advances in Rheumatology.

Dietary counseling aimed at losing or controlling weight could therefore be part of the global protocol for PsA patients, the researchers added. They conceded, however, that nonpharmacologic interventions traditionally have a low rate of adherence.

This recommendation aligns with a systematic review by the National Psoriasis Foundation, which found evidence of benefit with dietary weight reduction via a hypocaloric diet in overweight and obese patients with psoriasis and/or PsA. 
 

The DIETA trial

The 12-week randomized, double-blind, placebo-controlled study, conducted at three hospitals in São Paulo from September 2012 to May 2014, assessed whether dietary changes, antioxidant supplementation, or weight loss of 5%-10% could improve skin and joint activity in 97 enrolled PsA patients.

Participants were randomized into the following supervised dietary groups:

• Diet-placebo (hypocaloric diet plus placebo supplementation).
• Diet-fish (hypocaloric diet plus 3 g/day of omega-3 supplementation).
• Placebo (with habitual diet).

Diets were carefully tailored to each individual patient. The regimen for overweight and obese patients included a 500-kcal restriction, while for eutrophic patients, diets were calculated to maintain weight with no caloric restriction.

In the 91 patients evaluable by multiple measures at 12 weeks, Ms. Leite and colleagues observed the following:

• The Disease Activity Score 28 (DAS28) for Rheumatoid Arthritis with C-Reactive Protein and the Bath Ankylosing Spondylitis Disease Activity Index improved, especially in the diet-placebo group (−0.6 ± 0.9, P = .004 and −1.39 ± 1.97, P = .001, respectively).
• Minimal disease activity improved in all groups.
• The diet-fish group showed significant weight loss (−1.79 ± 2.4 kg, P = .004), as well as reductions in waist circumference (−3.28 ± 3.5 cm, P < .001) and body fat (−1.2 ± 2.2 kg, P = .006).

Other findings from this study showed the following:

• No significant correlation was seen between weight loss and disease activity improvement.
• Each 1-unit increase in the Healthy Eating Index value reduced the likelihood of achieving remission by 4%.
• Each 100-calorie increase per day caused a 3.4-fold impairment on the DAS28-Erythrocyte Sedimentation Rate score.

The fact that no changes in PsA, medications, or physical activity were made during the study period reinforces the role of diet in the context of immunometabolism, the authors said. Supervised exercise, however, could contribute to weight loss, lean muscle mass, and better disease activity control.

The authors stressed that the data suggest “increased energy intake and worse diet quality may negatively affect joint activity and reduce the likelihood of achieving disease remission, regardless of weight loss or body composition changes.”

“There are other studies that have looked at the effect of weight loss from a very low-calorie diet, and they’ve suggested that PsA symptoms can improve, said rheumatologist Eric. M. Ruderman, MD, a professor of medicine at Northwestern Medicine in Chicago, in an interview. “The unique piece here is that they found that the improvement was really independent of weight loss.”

Dr. Ruderman, who was not involved in DIETA, cautioned, however, that the study is small and saw improvement in the placebo group as well, which could suggest that some of the improvement was related to the extra attention and regular communication with the nutritionist that came with participation in the study.

“Also, the absolute improvement was small, and the dietary restriction was pretty aggressive, so I’m not sure how generalizable this really is. While there are lots of benefits to maintaining a healthy diet and exercising, I don’t think that the results of this small study would justify taking an aggressive [dietary] approach as part of the clinical playbook for all PsA patients.”

This study was supported by the São Paulo Research Foundation and the Coordination for Improvement in Higher Education Foundation of the Ministry of Education, Brazil.

The authors had no competing interests to declare.

Dr. Ruderman disclosed no relevant competing interests.
 

A 12-week hypocaloric diet provided suitable control of joint disease activity in patients with psoriatic arthritis (PsA), regardless of weight loss, Brazilian researchers found.

Earlier research has reported that weight loss improves the symptoms of PsA.

Improvement in the Brazilian DIETA study was linked to both better eating patterns and better quality of diet, and while omega-3 supplementation caused relevant body composition changes, it did not improve disease activity, according to Beatriz F. Leite of the division of rheumatology at the Federal University of São Paulo and colleagues.

“The DIETA trial, a nonpharmacologic approach, is an inexpensive, suitable, and efficient approach that could be combined with standardized drug therapy,” the investigators wrote online in Advances in Rheumatology.

Dietary counseling aimed at losing or controlling weight could therefore be part of the global protocol for PsA patients, the researchers added. They conceded, however, that nonpharmacologic interventions traditionally have a low rate of adherence.

This recommendation aligns with a systematic review by the National Psoriasis Foundation, which found evidence of benefit with dietary weight reduction via a hypocaloric diet in overweight and obese patients with psoriasis and/or PsA. 
 

The DIETA trial

The 12-week randomized, double-blind, placebo-controlled study, conducted at three hospitals in São Paulo from September 2012 to May 2014, assessed whether dietary changes, antioxidant supplementation, or weight loss of 5%-10% could improve skin and joint activity in 97 enrolled PsA patients.

Participants were randomized into the following supervised dietary groups:

• Diet-placebo (hypocaloric diet plus placebo supplementation).
• Diet-fish (hypocaloric diet plus 3 g/day of omega-3 supplementation).
• Placebo (with habitual diet).

Diets were carefully tailored to each individual patient. The regimen for overweight and obese patients included a 500-kcal restriction, while for eutrophic patients, diets were calculated to maintain weight with no caloric restriction.

In the 91 patients evaluable by multiple measures at 12 weeks, Ms. Leite and colleagues observed the following:

• The Disease Activity Score 28 (DAS28) for Rheumatoid Arthritis with C-Reactive Protein and the Bath Ankylosing Spondylitis Disease Activity Index improved, especially in the diet-placebo group (−0.6 ± 0.9, P = .004 and −1.39 ± 1.97, P = .001, respectively).
• Minimal disease activity improved in all groups.
• The diet-fish group showed significant weight loss (−1.79 ± 2.4 kg, P = .004), as well as reductions in waist circumference (−3.28 ± 3.5 cm, P < .001) and body fat (−1.2 ± 2.2 kg, P = .006).

Other findings from this study showed the following:

• No significant correlation was seen between weight loss and disease activity improvement.
• Each 1-unit increase in the Healthy Eating Index value reduced the likelihood of achieving remission by 4%.
• Each 100-calorie increase per day caused a 3.4-fold impairment on the DAS28-Erythrocyte Sedimentation Rate score.

The fact that no changes in PsA, medications, or physical activity were made during the study period reinforces the role of diet in the context of immunometabolism, the authors said. Supervised exercise, however, could contribute to weight loss, lean muscle mass, and better disease activity control.

The authors stressed that the data suggest “increased energy intake and worse diet quality may negatively affect joint activity and reduce the likelihood of achieving disease remission, regardless of weight loss or body composition changes.”

“There are other studies that have looked at the effect of weight loss from a very low-calorie diet, and they’ve suggested that PsA symptoms can improve, said rheumatologist Eric. M. Ruderman, MD, a professor of medicine at Northwestern Medicine in Chicago, in an interview. “The unique piece here is that they found that the improvement was really independent of weight loss.”

Dr. Ruderman, who was not involved in DIETA, cautioned, however, that the study is small and saw improvement in the placebo group as well, which could suggest that some of the improvement was related to the extra attention and regular communication with the nutritionist that came with participation in the study.

“Also, the absolute improvement was small, and the dietary restriction was pretty aggressive, so I’m not sure how generalizable this really is. While there are lots of benefits to maintaining a healthy diet and exercising, I don’t think that the results of this small study would justify taking an aggressive [dietary] approach as part of the clinical playbook for all PsA patients.”

This study was supported by the São Paulo Research Foundation and the Coordination for Improvement in Higher Education Foundation of the Ministry of Education, Brazil.

The authors had no competing interests to declare.

Dr. Ruderman disclosed no relevant competing interests.
 

A 12-week hypocaloric diet provided suitable control of joint disease activity in patients with psoriatic arthritis (PsA), regardless of weight loss, Brazilian researchers found.

Earlier research has reported that weight loss improves the symptoms of PsA.

Improvement in the Brazilian DIETA study was linked to both better eating patterns and better quality of diet, and while omega-3 supplementation caused relevant body composition changes, it did not improve disease activity, according to Beatriz F. Leite of the division of rheumatology at the Federal University of São Paulo and colleagues.

“The DIETA trial, a nonpharmacologic approach, is an inexpensive, suitable, and efficient approach that could be combined with standardized drug therapy,” the investigators wrote online in Advances in Rheumatology.

Dietary counseling aimed at losing or controlling weight could therefore be part of the global protocol for PsA patients, the researchers added. They conceded, however, that nonpharmacologic interventions traditionally have a low rate of adherence.

This recommendation aligns with a systematic review by the National Psoriasis Foundation, which found evidence of benefit with dietary weight reduction via a hypocaloric diet in overweight and obese patients with psoriasis and/or PsA. 
 

The DIETA trial

The 12-week randomized, double-blind, placebo-controlled study, conducted at three hospitals in São Paulo from September 2012 to May 2014, assessed whether dietary changes, antioxidant supplementation, or weight loss of 5%-10% could improve skin and joint activity in 97 enrolled PsA patients.

Participants were randomized into the following supervised dietary groups:

• Diet-placebo (hypocaloric diet plus placebo supplementation).
• Diet-fish (hypocaloric diet plus 3 g/day of omega-3 supplementation).
• Placebo (with habitual diet).

Diets were carefully tailored to each individual patient. The regimen for overweight and obese patients included a 500-kcal restriction, while for eutrophic patients, diets were calculated to maintain weight with no caloric restriction.

In the 91 patients evaluable by multiple measures at 12 weeks, Ms. Leite and colleagues observed the following:

• The Disease Activity Score 28 (DAS28) for Rheumatoid Arthritis with C-Reactive Protein and the Bath Ankylosing Spondylitis Disease Activity Index improved, especially in the diet-placebo group (−0.6 ± 0.9, P = .004 and −1.39 ± 1.97, P = .001, respectively).
• Minimal disease activity improved in all groups.
• The diet-fish group showed significant weight loss (−1.79 ± 2.4 kg, P = .004), as well as reductions in waist circumference (−3.28 ± 3.5 cm, P < .001) and body fat (−1.2 ± 2.2 kg, P = .006).

Other findings from this study showed the following:

• No significant correlation was seen between weight loss and disease activity improvement.
• Each 1-unit increase in the Healthy Eating Index value reduced the likelihood of achieving remission by 4%.
• Each 100-calorie increase per day caused a 3.4-fold impairment on the DAS28-Erythrocyte Sedimentation Rate score.

The fact that no changes in PsA, medications, or physical activity were made during the study period reinforces the role of diet in the context of immunometabolism, the authors said. Supervised exercise, however, could contribute to weight loss, lean muscle mass, and better disease activity control.

The authors stressed that the data suggest “increased energy intake and worse diet quality may negatively affect joint activity and reduce the likelihood of achieving disease remission, regardless of weight loss or body composition changes.”

“There are other studies that have looked at the effect of weight loss from a very low-calorie diet, and they’ve suggested that PsA symptoms can improve, said rheumatologist Eric. M. Ruderman, MD, a professor of medicine at Northwestern Medicine in Chicago, in an interview. “The unique piece here is that they found that the improvement was really independent of weight loss.”

Dr. Ruderman, who was not involved in DIETA, cautioned, however, that the study is small and saw improvement in the placebo group as well, which could suggest that some of the improvement was related to the extra attention and regular communication with the nutritionist that came with participation in the study.

“Also, the absolute improvement was small, and the dietary restriction was pretty aggressive, so I’m not sure how generalizable this really is. While there are lots of benefits to maintaining a healthy diet and exercising, I don’t think that the results of this small study would justify taking an aggressive [dietary] approach as part of the clinical playbook for all PsA patients.”

This study was supported by the São Paulo Research Foundation and the Coordination for Improvement in Higher Education Foundation of the Ministry of Education, Brazil.

The authors had no competing interests to declare.

Dr. Ruderman disclosed no relevant competing interests.
 

Reports of long waiting times at mental health clinics and anecdotal observations by health care providers suggest the pandemic has generated a dramatic increase in the incidence of eating disorders among the pediatric population. Of course this should come as no surprise to pediatricians.

Eating disorders come in many different forms and a triggering event is sometimes difficult to define. Often the adolescent or preadolescent is searching for some sense of stability in a life tossed on a stormy sea roiled by hormonal and physical change. Wresting control of their bodies during a period of uncertainty may result in a downward spiral into dangerously unhealthy weight loss. If nothing else, the pandemic has been a period of dramatic uncertainty unlike what most children and few adults in this country have ever experienced.

With the unprecedented increase in eating disorder cases, providers in several disciplines are searching for novel strategies to ease the burden on their patients and their practices. I recently learned of a pediatric practice in California that is considering blinding all patients aged 12 and older to the body mass measurements obtained at their health maintenance visits.

Blind weight checks for children with eating disorders, particularly those who seem to be nearing recovery, has been a common and often helpful practice. However, I am unaware of any practice that has made it a universal office policy. I’m unsure of the rationale behind this practice’s policy, but on several fronts, suppressing body mass measurements in the age group most vulnerable to eating disorders makes some sense.

Universal blind weight checks could minimize the risk of in-office shaming. However, careful training of support staff and thoughtful placement of the scales could serve the same purpose. This new policy acknowledges not only the ubiquity of the problem but also that many, maybe even most, children with eating disorders appear normal. And of course, there is the unfortunate fact that body mass is a poor screening test for eating disorders.

As I thought more about this novel approach I came to see its educational value for patients, parents, and even physicians. I can envision how a 13-year-old’s first health maintenance visit would go after the roll-out of the new policy. “Dr. Smith, aren’t you going to tell us how much I (or my daughter Jenny) weigh(s)?” This could, or more likely, should launch a discussion about weight and body image. It might continue with questions like, “How much do you think you weigh?” Or, “Do you think you are too heavy or too thin?”

Or, the conversation could include the provider’s observations that weight is just one measure of health and in fact not a very good one. Other ingredients in a healthy life style, such as sleep and physical activity, are not as easy to measure as weight but in many cases are more important.

As my mind struggled to restructure a health maintenance schedule that included blind weight checks, I wondered why we should wait until age 12. Of course, it is unreasonable to expect parents to stick with a pediatric practice that seems to ignore their infant’s weight. I’m sure that, like me, you have always discouraged new parents from having a baby scale at home because in the first few months too-frequent weighings can usually cause more angst than good.

It might make sense to remove a within-earshot discussion of a child’s weight from the health maintenance visit as soon as the child can absorb and digest the discussion; say, around age 3 years. In a perfect world, the provider should have already elicited a history that suggested a young child’s vulnerability to obesity before the scale and the growth chart told the unfortunate story. But, neither you nor I are perfect providers and so we will always need the scale to document our concerns. However, when and how we report that one vital sign to the patient and his or her parents is a topic ripe for discussion and improvement.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Reports of long waiting times at mental health clinics and anecdotal observations by health care providers suggest the pandemic has generated a dramatic increase in the incidence of eating disorders among the pediatric population. Of course this should come as no surprise to pediatricians.

Eating disorders come in many different forms and a triggering event is sometimes difficult to define. Often the adolescent or preadolescent is searching for some sense of stability in a life tossed on a stormy sea roiled by hormonal and physical change. Wresting control of their bodies during a period of uncertainty may result in a downward spiral into dangerously unhealthy weight loss. If nothing else, the pandemic has been a period of dramatic uncertainty unlike what most children and few adults in this country have ever experienced.

With the unprecedented increase in eating disorder cases, providers in several disciplines are searching for novel strategies to ease the burden on their patients and their practices. I recently learned of a pediatric practice in California that is considering blinding all patients aged 12 and older to the body mass measurements obtained at their health maintenance visits.

Blind weight checks for children with eating disorders, particularly those who seem to be nearing recovery, has been a common and often helpful practice. However, I am unaware of any practice that has made it a universal office policy. I’m unsure of the rationale behind this practice’s policy, but on several fronts, suppressing body mass measurements in the age group most vulnerable to eating disorders makes some sense.

Universal blind weight checks could minimize the risk of in-office shaming. However, careful training of support staff and thoughtful placement of the scales could serve the same purpose. This new policy acknowledges not only the ubiquity of the problem but also that many, maybe even most, children with eating disorders appear normal. And of course, there is the unfortunate fact that body mass is a poor screening test for eating disorders.

As I thought more about this novel approach I came to see its educational value for patients, parents, and even physicians. I can envision how a 13-year-old’s first health maintenance visit would go after the roll-out of the new policy. “Dr. Smith, aren’t you going to tell us how much I (or my daughter Jenny) weigh(s)?” This could, or more likely, should launch a discussion about weight and body image. It might continue with questions like, “How much do you think you weigh?” Or, “Do you think you are too heavy or too thin?”

Or, the conversation could include the provider’s observations that weight is just one measure of health and in fact not a very good one. Other ingredients in a healthy life style, such as sleep and physical activity, are not as easy to measure as weight but in many cases are more important.

As my mind struggled to restructure a health maintenance schedule that included blind weight checks, I wondered why we should wait until age 12. Of course, it is unreasonable to expect parents to stick with a pediatric practice that seems to ignore their infant’s weight. I’m sure that, like me, you have always discouraged new parents from having a baby scale at home because in the first few months too-frequent weighings can usually cause more angst than good.

It might make sense to remove a within-earshot discussion of a child’s weight from the health maintenance visit as soon as the child can absorb and digest the discussion; say, around age 3 years. In a perfect world, the provider should have already elicited a history that suggested a young child’s vulnerability to obesity before the scale and the growth chart told the unfortunate story. But, neither you nor I are perfect providers and so we will always need the scale to document our concerns. However, when and how we report that one vital sign to the patient and his or her parents is a topic ripe for discussion and improvement.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Reports of long waiting times at mental health clinics and anecdotal observations by health care providers suggest the pandemic has generated a dramatic increase in the incidence of eating disorders among the pediatric population. Of course this should come as no surprise to pediatricians.

Eating disorders come in many different forms and a triggering event is sometimes difficult to define. Often the adolescent or preadolescent is searching for some sense of stability in a life tossed on a stormy sea roiled by hormonal and physical change. Wresting control of their bodies during a period of uncertainty may result in a downward spiral into dangerously unhealthy weight loss. If nothing else, the pandemic has been a period of dramatic uncertainty unlike what most children and few adults in this country have ever experienced.

With the unprecedented increase in eating disorder cases, providers in several disciplines are searching for novel strategies to ease the burden on their patients and their practices. I recently learned of a pediatric practice in California that is considering blinding all patients aged 12 and older to the body mass measurements obtained at their health maintenance visits.

Blind weight checks for children with eating disorders, particularly those who seem to be nearing recovery, has been a common and often helpful practice. However, I am unaware of any practice that has made it a universal office policy. I’m unsure of the rationale behind this practice’s policy, but on several fronts, suppressing body mass measurements in the age group most vulnerable to eating disorders makes some sense.

Universal blind weight checks could minimize the risk of in-office shaming. However, careful training of support staff and thoughtful placement of the scales could serve the same purpose. This new policy acknowledges not only the ubiquity of the problem but also that many, maybe even most, children with eating disorders appear normal. And of course, there is the unfortunate fact that body mass is a poor screening test for eating disorders.

As I thought more about this novel approach I came to see its educational value for patients, parents, and even physicians. I can envision how a 13-year-old’s first health maintenance visit would go after the roll-out of the new policy. “Dr. Smith, aren’t you going to tell us how much I (or my daughter Jenny) weigh(s)?” This could, or more likely, should launch a discussion about weight and body image. It might continue with questions like, “How much do you think you weigh?” Or, “Do you think you are too heavy or too thin?”

Or, the conversation could include the provider’s observations that weight is just one measure of health and in fact not a very good one. Other ingredients in a healthy life style, such as sleep and physical activity, are not as easy to measure as weight but in many cases are more important.

As my mind struggled to restructure a health maintenance schedule that included blind weight checks, I wondered why we should wait until age 12. Of course, it is unreasonable to expect parents to stick with a pediatric practice that seems to ignore their infant’s weight. I’m sure that, like me, you have always discouraged new parents from having a baby scale at home because in the first few months too-frequent weighings can usually cause more angst than good.

It might make sense to remove a within-earshot discussion of a child’s weight from the health maintenance visit as soon as the child can absorb and digest the discussion; say, around age 3 years. In a perfect world, the provider should have already elicited a history that suggested a young child’s vulnerability to obesity before the scale and the growth chart told the unfortunate story. But, neither you nor I are perfect providers and so we will always need the scale to document our concerns. However, when and how we report that one vital sign to the patient and his or her parents is a topic ripe for discussion and improvement.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

In a head-to-head comparison of fractional flow reserve (FFR) and intravenous ultrasound (IVUS) for guiding revascularization during percutaneous intervention (PCI), outcomes were noninferior at 2 years, but the approaches appear to have different strengths, according to results of the FLAVOUR trial.

For the primary composite outcome of death from any cause, myocardial infarction, or revascularization at 24 months, the approaches performed comparatively, but there were substantial differences in the number of revascularization procedures performed, reported Bon-Kwon Koo, MD, at the annual scientific sessions of the American College of Cardiology.

At 24 months, 8.1% of the FFR group and 8.5% of the IVUS group had a primary event. The 0.4% difference was not significantly different and fulfilled the definition of noninferiority (P = .015). When the components of the primary endpoint were compared along with rates of stroke, the rates were also similar and not significantly different.

However, the proportion of patients who received a stent (44.4% vs. 65.3%), the total number of stents per patient (0.6 vs. 0.9), and the total stent length per patient (16.5 vs. 25.2) were significantly lower (all P < .001) in the FFR group.

FLAVOUR (Fractional Flow Reserve And IVUS for Clinical Outcomes in Patients With Intermediate Stenosis) confirmed the investigators’ hypothesis that an FFR-guided strategy for intermediate coronary stenosis is noninferior to IVUS for outcomes. In addition, patient-reported angina outcomes on the Seattle Angina Questionnaire were nearly identical across domains, including angina frequency, physical limitations, and treatment satisfaction.
 

FFR vs. IVUS differences revealed

However, the more important value of this study might its role in showing how the two approaches differ in ways unrelated to the primary outcome, according to Dr. Koo, chair of cardiology at Seoul (South Korea) National University Hospital, as well as several experts that commented on the results.

Most notably, the fact that FFR-guided PCI provides similar outcomes at 2 years even though it was associated with a substantially reduced rate of revascularizations is telling about its role relative to IVUS.

“These data confirm how a lot of us are already approaching this,” said an ACC-invited expert, Frederick G. Welt, MD, director of the cardiac catheterization at the University of Utah, Salt Lake City. “FFR should be used to decide who should get an intervention, and IVUS should be use to optimize the intervention.”

Dr. Koo explained that FFR is an invasive tool that provides a physiological assessment of the degree to which a stenosis is causing ischemia. IVUS is a tool that permits visualization and measurement of plaque severity and characteristics to better optimize PCI. They can both help guide PCI, but they are not necessarily competing strategies. Often, the information they provide is complementary.

In this multicenter trial conducted at 18 centers in Korea and China, 1,682 candidates with de novo stenoses of intermediate severity, defined as 40%-70%, were randomized to FFR- or IVUS-guided PCI. At 24 months, outcomes could be assessed in 832 of the FFR patients and 836 of the IVUS patients, which represented more than 99% of both groups.

In the study, the indications for stent placement were predefined for the FFR-guided and IVUS-guided approaches. The criteria to define optimal outcomes post PCI were also predefined. For FFR, this included a postprocedure value of at least 0.88. For IVUS, the definition of optimal outcome included a plaque burden of 55% or less at the stent edge and a minimal stent area of at least 5.5 mm².

The primary outcome for those with optimal versus suboptimal FFR-guided PCI were similar at all time points. For those with an optimal post-PCI result, the event rate was only slightly higher for those with an optimal relative to a suboptimal result (12.3% vs. 11.8%).
 

Suboptimal IVUS differs from suboptimal FFR

In contrast, the event rates over the course of follow-up were consistently higher among those with a suboptimal relative to an optimal IVUS-guided PCI. At the end of 2 years, the numerically greater rate of events among those with a suboptimal IVUS-guided PCI was not significant (9.8% vs. 8.5%; P = .212), but the gap was larger than that seen with FFR-guided PCI.

FFR-guided and IVUS-guided PCI performed similarly for the primary outcome across numerous stratifications. These included age older or younger than 65 years, male or female sex, presence or absence of multivessel disease, and presence of diabetes. They were also similar for those with acute coronary syndrome (ACS) as an indication for PCI, which accounted for about 30% of patients, relative to those without ACS.

“I would say that at least some interventionalists in the U.S. would be uncomfortable using FFR in ACS patients,” said Dr. Welt, pointing out a potential difference between how these tools are used to guide PCI. Still, because “there are not a lot of data to compare these technologies,” he expressed appreciation for a study looking at these tools side-by-side.

A similar point was made by Ajay Kirtane, MD, director of Cardiac Catheterization Laboratories at New York–Presbyterian/Columbia University Irving Medical Center. With the slightly lower rates of primary events in those treated optimally according to IVUS relative to those treated optimally by FFR (8.5% vs. 12.3%), he suggested IVUS appears better for evaluating the physiology of the stenosis.

Dr. Kirtane pointed out that two-thirds of the lesions were left behind in those guided by FFR versus only about half of the lesions when PCI was guided by IVUS, yet outcomes were similar. He indicated that the data support current practice in which FFR is most commonly used to select PCI patients with intermediate disease for stent placement.

Dr. Koo has financial relationships with Abbott, Boston Scientific, and Philips Volcano. Dr. Welt has financial relationships with Medtronic and Xenter. Dr. Kirtane has financial relationships with Abbott, Amgen, Boston Scientific, Chiesi, Cardiovascular Systems Incorporate, Medtronic, Philips/Spectranetics, Recor Medical, and Regeneron. The study received a research grant from Boston Scientific.

In a head-to-head comparison of fractional flow reserve (FFR) and intravenous ultrasound (IVUS) for guiding revascularization during percutaneous intervention (PCI), outcomes were noninferior at 2 years, but the approaches appear to have different strengths, according to results of the FLAVOUR trial.

For the primary composite outcome of death from any cause, myocardial infarction, or revascularization at 24 months, the approaches performed comparatively, but there were substantial differences in the number of revascularization procedures performed, reported Bon-Kwon Koo, MD, at the annual scientific sessions of the American College of Cardiology.

At 24 months, 8.1% of the FFR group and 8.5% of the IVUS group had a primary event. The 0.4% difference was not significantly different and fulfilled the definition of noninferiority (P = .015). When the components of the primary endpoint were compared along with rates of stroke, the rates were also similar and not significantly different.

However, the proportion of patients who received a stent (44.4% vs. 65.3%), the total number of stents per patient (0.6 vs. 0.9), and the total stent length per patient (16.5 vs. 25.2) were significantly lower (all P < .001) in the FFR group.

FLAVOUR (Fractional Flow Reserve And IVUS for Clinical Outcomes in Patients With Intermediate Stenosis) confirmed the investigators’ hypothesis that an FFR-guided strategy for intermediate coronary stenosis is noninferior to IVUS for outcomes. In addition, patient-reported angina outcomes on the Seattle Angina Questionnaire were nearly identical across domains, including angina frequency, physical limitations, and treatment satisfaction.
 

FFR vs. IVUS differences revealed

However, the more important value of this study might its role in showing how the two approaches differ in ways unrelated to the primary outcome, according to Dr. Koo, chair of cardiology at Seoul (South Korea) National University Hospital, as well as several experts that commented on the results.

Most notably, the fact that FFR-guided PCI provides similar outcomes at 2 years even though it was associated with a substantially reduced rate of revascularizations is telling about its role relative to IVUS.

“These data confirm how a lot of us are already approaching this,” said an ACC-invited expert, Frederick G. Welt, MD, director of the cardiac catheterization at the University of Utah, Salt Lake City. “FFR should be used to decide who should get an intervention, and IVUS should be use to optimize the intervention.”

Dr. Koo explained that FFR is an invasive tool that provides a physiological assessment of the degree to which a stenosis is causing ischemia. IVUS is a tool that permits visualization and measurement of plaque severity and characteristics to better optimize PCI. They can both help guide PCI, but they are not necessarily competing strategies. Often, the information they provide is complementary.

In this multicenter trial conducted at 18 centers in Korea and China, 1,682 candidates with de novo stenoses of intermediate severity, defined as 40%-70%, were randomized to FFR- or IVUS-guided PCI. At 24 months, outcomes could be assessed in 832 of the FFR patients and 836 of the IVUS patients, which represented more than 99% of both groups.

In the study, the indications for stent placement were predefined for the FFR-guided and IVUS-guided approaches. The criteria to define optimal outcomes post PCI were also predefined. For FFR, this included a postprocedure value of at least 0.88. For IVUS, the definition of optimal outcome included a plaque burden of 55% or less at the stent edge and a minimal stent area of at least 5.5 mm².

The primary outcome for those with optimal versus suboptimal FFR-guided PCI were similar at all time points. For those with an optimal post-PCI result, the event rate was only slightly higher for those with an optimal relative to a suboptimal result (12.3% vs. 11.8%).
 

Suboptimal IVUS differs from suboptimal FFR

In contrast, the event rates over the course of follow-up were consistently higher among those with a suboptimal relative to an optimal IVUS-guided PCI. At the end of 2 years, the numerically greater rate of events among those with a suboptimal IVUS-guided PCI was not significant (9.8% vs. 8.5%; P = .212), but the gap was larger than that seen with FFR-guided PCI.

FFR-guided and IVUS-guided PCI performed similarly for the primary outcome across numerous stratifications. These included age older or younger than 65 years, male or female sex, presence or absence of multivessel disease, and presence of diabetes. They were also similar for those with acute coronary syndrome (ACS) as an indication for PCI, which accounted for about 30% of patients, relative to those without ACS.

“I would say that at least some interventionalists in the U.S. would be uncomfortable using FFR in ACS patients,” said Dr. Welt, pointing out a potential difference between how these tools are used to guide PCI. Still, because “there are not a lot of data to compare these technologies,” he expressed appreciation for a study looking at these tools side-by-side.

A similar point was made by Ajay Kirtane, MD, director of Cardiac Catheterization Laboratories at New York–Presbyterian/Columbia University Irving Medical Center. With the slightly lower rates of primary events in those treated optimally according to IVUS relative to those treated optimally by FFR (8.5% vs. 12.3%), he suggested IVUS appears better for evaluating the physiology of the stenosis.

Dr. Kirtane pointed out that two-thirds of the lesions were left behind in those guided by FFR versus only about half of the lesions when PCI was guided by IVUS, yet outcomes were similar. He indicated that the data support current practice in which FFR is most commonly used to select PCI patients with intermediate disease for stent placement.

Dr. Koo has financial relationships with Abbott, Boston Scientific, and Philips Volcano. Dr. Welt has financial relationships with Medtronic and Xenter. Dr. Kirtane has financial relationships with Abbott, Amgen, Boston Scientific, Chiesi, Cardiovascular Systems Incorporate, Medtronic, Philips/Spectranetics, Recor Medical, and Regeneron. The study received a research grant from Boston Scientific.

In a head-to-head comparison of fractional flow reserve (FFR) and intravenous ultrasound (IVUS) for guiding revascularization during percutaneous intervention (PCI), outcomes were noninferior at 2 years, but the approaches appear to have different strengths, according to results of the FLAVOUR trial.

For the primary composite outcome of death from any cause, myocardial infarction, or revascularization at 24 months, the approaches performed comparatively, but there were substantial differences in the number of revascularization procedures performed, reported Bon-Kwon Koo, MD, at the annual scientific sessions of the American College of Cardiology.

At 24 months, 8.1% of the FFR group and 8.5% of the IVUS group had a primary event. The 0.4% difference was not significantly different and fulfilled the definition of noninferiority (P = .015). When the components of the primary endpoint were compared along with rates of stroke, the rates were also similar and not significantly different.

However, the proportion of patients who received a stent (44.4% vs. 65.3%), the total number of stents per patient (0.6 vs. 0.9), and the total stent length per patient (16.5 vs. 25.2) were significantly lower (all P < .001) in the FFR group.

FLAVOUR (Fractional Flow Reserve And IVUS for Clinical Outcomes in Patients With Intermediate Stenosis) confirmed the investigators’ hypothesis that an FFR-guided strategy for intermediate coronary stenosis is noninferior to IVUS for outcomes. In addition, patient-reported angina outcomes on the Seattle Angina Questionnaire were nearly identical across domains, including angina frequency, physical limitations, and treatment satisfaction.
 

FFR vs. IVUS differences revealed

However, the more important value of this study might its role in showing how the two approaches differ in ways unrelated to the primary outcome, according to Dr. Koo, chair of cardiology at Seoul (South Korea) National University Hospital, as well as several experts that commented on the results.

Most notably, the fact that FFR-guided PCI provides similar outcomes at 2 years even though it was associated with a substantially reduced rate of revascularizations is telling about its role relative to IVUS.

“These data confirm how a lot of us are already approaching this,” said an ACC-invited expert, Frederick G. Welt, MD, director of the cardiac catheterization at the University of Utah, Salt Lake City. “FFR should be used to decide who should get an intervention, and IVUS should be use to optimize the intervention.”

Dr. Koo explained that FFR is an invasive tool that provides a physiological assessment of the degree to which a stenosis is causing ischemia. IVUS is a tool that permits visualization and measurement of plaque severity and characteristics to better optimize PCI. They can both help guide PCI, but they are not necessarily competing strategies. Often, the information they provide is complementary.

In this multicenter trial conducted at 18 centers in Korea and China, 1,682 candidates with de novo stenoses of intermediate severity, defined as 40%-70%, were randomized to FFR- or IVUS-guided PCI. At 24 months, outcomes could be assessed in 832 of the FFR patients and 836 of the IVUS patients, which represented more than 99% of both groups.

In the study, the indications for stent placement were predefined for the FFR-guided and IVUS-guided approaches. The criteria to define optimal outcomes post PCI were also predefined. For FFR, this included a postprocedure value of at least 0.88. For IVUS, the definition of optimal outcome included a plaque burden of 55% or less at the stent edge and a minimal stent area of at least 5.5 mm².

The primary outcome for those with optimal versus suboptimal FFR-guided PCI were similar at all time points. For those with an optimal post-PCI result, the event rate was only slightly higher for those with an optimal relative to a suboptimal result (12.3% vs. 11.8%).
 

Suboptimal IVUS differs from suboptimal FFR

In contrast, the event rates over the course of follow-up were consistently higher among those with a suboptimal relative to an optimal IVUS-guided PCI. At the end of 2 years, the numerically greater rate of events among those with a suboptimal IVUS-guided PCI was not significant (9.8% vs. 8.5%; P = .212), but the gap was larger than that seen with FFR-guided PCI.

FFR-guided and IVUS-guided PCI performed similarly for the primary outcome across numerous stratifications. These included age older or younger than 65 years, male or female sex, presence or absence of multivessel disease, and presence of diabetes. They were also similar for those with acute coronary syndrome (ACS) as an indication for PCI, which accounted for about 30% of patients, relative to those without ACS.

“I would say that at least some interventionalists in the U.S. would be uncomfortable using FFR in ACS patients,” said Dr. Welt, pointing out a potential difference between how these tools are used to guide PCI. Still, because “there are not a lot of data to compare these technologies,” he expressed appreciation for a study looking at these tools side-by-side.

A similar point was made by Ajay Kirtane, MD, director of Cardiac Catheterization Laboratories at New York–Presbyterian/Columbia University Irving Medical Center. With the slightly lower rates of primary events in those treated optimally according to IVUS relative to those treated optimally by FFR (8.5% vs. 12.3%), he suggested IVUS appears better for evaluating the physiology of the stenosis.

Dr. Kirtane pointed out that two-thirds of the lesions were left behind in those guided by FFR versus only about half of the lesions when PCI was guided by IVUS, yet outcomes were similar. He indicated that the data support current practice in which FFR is most commonly used to select PCI patients with intermediate disease for stent placement.

Dr. Koo has financial relationships with Abbott, Boston Scientific, and Philips Volcano. Dr. Welt has financial relationships with Medtronic and Xenter. Dr. Kirtane has financial relationships with Abbott, Amgen, Boston Scientific, Chiesi, Cardiovascular Systems Incorporate, Medtronic, Philips/Spectranetics, Recor Medical, and Regeneron. The study received a research grant from Boston Scientific.

Hospitalized patients who are asymptomatic Clostridioides difficile carriers may infect people they live with after they return home, a study based on U.S. insurance claim data suggests.

Although C. difficile infection (CDI) is considered to be a common hospital-acquired infection, reports of community-associated CDI in patients who have not been hospitalized are increasing, the authors wrote in Emerging Infectious Diseases.

“Individuals in households where another family member was recently hospitalized but not diagnosed with a CDI appear to be at increased risk for CDI,” said lead author Aaron C. Miller, PhD, a research assistant professor in the department of internal medicine at the University of Iowa, Iowa City. “When individuals are hospitalized, they may become colonized with C. difficile without developing symptoms and subsequently transmit the pathogen to other family members after they return home,” he said by email.

Dr. Miller and colleagues analyzed insurance claims data from 2001 through 2017 using the U.S. Commercial Claims and Medicare Supplemental datasets of IBM MarketScan Research Databases. Over that period, they searched employer-sponsored commercial insurance claims and Medicare supplemental claims of 194,424 enrollees, and they linked claims from multiple family members in the same enrollment plan.

They identified 224,818 CDI cases, and 3,871 of them were considered potential asymptomatic C. difficile transmissions from a recently hospitalized family member.

The researchers gathered monthly C. difficile incidence data from households with a family member who had been hospitalized within the past 60 days and compared them with data from households without a hospitalized family member.

Enrollees exposed to a recently hospitalized family member had a 73% greater incidence of CDI compared with enrollees who were not exposed. The longer the family member’s hospital stay, the greater the risk that someone in the household became infected.

Compared with people whose family members were hospitalized less than 1 day, people whose family members were hospitalized from 1 to 3 days had an incidence rate ratio (IRR) of 1.30 (95% confidence interval [CI], 1.19-1.41), and those whose family members were hospitalized for more than 30 days had an IRR of 2.45 (95% CI, 1.66-3.60).

CDI incidence increased with age. Compared with people 17 years of age or younger, the IRR increased to 9.32 (95% CI, 8.92-9.73) for those over 65.

Females had higher CDI incidence than males (IRR 1.30; 95% CI, 1.28-1.33).

Households with an infant also had higher CDI incidence than those without (IRR 1.5; 95% CI, 1.44-1.58).

People taking antimicrobials had higher CDI IRRs: 2.69 (95% CI, 2.59-2.79) for low-CDI-risk antibiotics and 8.83 (95% CI, 8.63-9.03) for high-CDI-risk antibiotics.

People taking proton-pump inhibitors had an IRR of 2.23 (95% CI, 2.15-2.30).
 

Reactions from four experts

Douglas S. Paauw MD, MACP, professor of medicine and the chair for patient-centered clinical education at the University of Washington, Seattle, was not surprised by the findings. “We have wondered for a while how community-acquired CDI occurs,” he said in an email. “This important study offers a plausible explanation for some cases.”

Dr. Paauw advises doctors to consider CDI in their patients who have been exposed to hospitalized people.

David M. Aronoff, MD, FIDSA, FAAM, professor of medicine and the chair of the department of medicine at Indiana University, Indianapolis, advises providers to educate hospital patients being discharged about how CDI is spread and how they can practice good hand hygiene at home.

“An open question of this strong study is whether we should be testing certain hospital patients for asymptomatic C. difficile carriage before they are discharged,” he added in an email.

In a phone interview, Paul G. Auwaerter, MD, MBA, professor of medicine and clinical director of the division of infectious diseases at Johns Hopkins University, Baltimore, noted that community-acquired CDI is frequent enough that his institution performs routine C. difficile testing on all patients with unexplained severe diarrhea.

“This intriguing study bears additional research and follow-up because clearly these spores are hardy,” he said. “But a key point in this billings- and claims-based study is that no one knows where household members acquired CDI, whether it was actually through household transmission.”

Ramin Asgary, MD, MPH, FASTMH, associate professor of global health in the Milken Institute School of Public Health at George Washington University, Washington, cautioned about “an increasing issue with drug-resistant CDI.

“This important, timely study provides another step in the right direction to better understanding and addressing CDI and other hospital-based infections that have become increasing threats to the safety of our patients, their families, and health care in general,” he said in an email.

Dr. Miller said that the scale and scope of the data are strengths of the study, and he acknowledged that its basis in claims and billing data is a limitation. He and his group plan to explore genetic relationships involved in CDI transmission.

The study was funded by the Centers for Disease Control and Prevention. All authors and independent experts have disclosed no relevant financial relationships.

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

Hospitalized patients who are asymptomatic Clostridioides difficile carriers may infect people they live with after they return home, a study based on U.S. insurance claim data suggests.

Although C. difficile infection (CDI) is considered to be a common hospital-acquired infection, reports of community-associated CDI in patients who have not been hospitalized are increasing, the authors wrote in Emerging Infectious Diseases.

“Individuals in households where another family member was recently hospitalized but not diagnosed with a CDI appear to be at increased risk for CDI,” said lead author Aaron C. Miller, PhD, a research assistant professor in the department of internal medicine at the University of Iowa, Iowa City. “When individuals are hospitalized, they may become colonized with C. difficile without developing symptoms and subsequently transmit the pathogen to other family members after they return home,” he said by email.

Dr. Miller and colleagues analyzed insurance claims data from 2001 through 2017 using the U.S. Commercial Claims and Medicare Supplemental datasets of IBM MarketScan Research Databases. Over that period, they searched employer-sponsored commercial insurance claims and Medicare supplemental claims of 194,424 enrollees, and they linked claims from multiple family members in the same enrollment plan.

They identified 224,818 CDI cases, and 3,871 of them were considered potential asymptomatic C. difficile transmissions from a recently hospitalized family member.

The researchers gathered monthly C. difficile incidence data from households with a family member who had been hospitalized within the past 60 days and compared them with data from households without a hospitalized family member.

Enrollees exposed to a recently hospitalized family member had a 73% greater incidence of CDI compared with enrollees who were not exposed. The longer the family member’s hospital stay, the greater the risk that someone in the household became infected.

Compared with people whose family members were hospitalized less than 1 day, people whose family members were hospitalized from 1 to 3 days had an incidence rate ratio (IRR) of 1.30 (95% confidence interval [CI], 1.19-1.41), and those whose family members were hospitalized for more than 30 days had an IRR of 2.45 (95% CI, 1.66-3.60).

CDI incidence increased with age. Compared with people 17 years of age or younger, the IRR increased to 9.32 (95% CI, 8.92-9.73) for those over 65.

Females had higher CDI incidence than males (IRR 1.30; 95% CI, 1.28-1.33).

Households with an infant also had higher CDI incidence than those without (IRR 1.5; 95% CI, 1.44-1.58).

People taking antimicrobials had higher CDI IRRs: 2.69 (95% CI, 2.59-2.79) for low-CDI-risk antibiotics and 8.83 (95% CI, 8.63-9.03) for high-CDI-risk antibiotics.

People taking proton-pump inhibitors had an IRR of 2.23 (95% CI, 2.15-2.30).
 

Reactions from four experts

Douglas S. Paauw MD, MACP, professor of medicine and the chair for patient-centered clinical education at the University of Washington, Seattle, was not surprised by the findings. “We have wondered for a while how community-acquired CDI occurs,” he said in an email. “This important study offers a plausible explanation for some cases.”

Dr. Paauw advises doctors to consider CDI in their patients who have been exposed to hospitalized people.

David M. Aronoff, MD, FIDSA, FAAM, professor of medicine and the chair of the department of medicine at Indiana University, Indianapolis, advises providers to educate hospital patients being discharged about how CDI is spread and how they can practice good hand hygiene at home.

“An open question of this strong study is whether we should be testing certain hospital patients for asymptomatic C. difficile carriage before they are discharged,” he added in an email.

In a phone interview, Paul G. Auwaerter, MD, MBA, professor of medicine and clinical director of the division of infectious diseases at Johns Hopkins University, Baltimore, noted that community-acquired CDI is frequent enough that his institution performs routine C. difficile testing on all patients with unexplained severe diarrhea.

“This intriguing study bears additional research and follow-up because clearly these spores are hardy,” he said. “But a key point in this billings- and claims-based study is that no one knows where household members acquired CDI, whether it was actually through household transmission.”

Ramin Asgary, MD, MPH, FASTMH, associate professor of global health in the Milken Institute School of Public Health at George Washington University, Washington, cautioned about “an increasing issue with drug-resistant CDI.

“This important, timely study provides another step in the right direction to better understanding and addressing CDI and other hospital-based infections that have become increasing threats to the safety of our patients, their families, and health care in general,” he said in an email.

Dr. Miller said that the scale and scope of the data are strengths of the study, and he acknowledged that its basis in claims and billing data is a limitation. He and his group plan to explore genetic relationships involved in CDI transmission.

The study was funded by the Centers for Disease Control and Prevention. All authors and independent experts have disclosed no relevant financial relationships.

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

Hospitalized patients who are asymptomatic Clostridioides difficile carriers may infect people they live with after they return home, a study based on U.S. insurance claim data suggests.

Although C. difficile infection (CDI) is considered to be a common hospital-acquired infection, reports of community-associated CDI in patients who have not been hospitalized are increasing, the authors wrote in Emerging Infectious Diseases.

“Individuals in households where another family member was recently hospitalized but not diagnosed with a CDI appear to be at increased risk for CDI,” said lead author Aaron C. Miller, PhD, a research assistant professor in the department of internal medicine at the University of Iowa, Iowa City. “When individuals are hospitalized, they may become colonized with C. difficile without developing symptoms and subsequently transmit the pathogen to other family members after they return home,” he said by email.

Dr. Miller and colleagues analyzed insurance claims data from 2001 through 2017 using the U.S. Commercial Claims and Medicare Supplemental datasets of IBM MarketScan Research Databases. Over that period, they searched employer-sponsored commercial insurance claims and Medicare supplemental claims of 194,424 enrollees, and they linked claims from multiple family members in the same enrollment plan.

They identified 224,818 CDI cases, and 3,871 of them were considered potential asymptomatic C. difficile transmissions from a recently hospitalized family member.

The researchers gathered monthly C. difficile incidence data from households with a family member who had been hospitalized within the past 60 days and compared them with data from households without a hospitalized family member.

Enrollees exposed to a recently hospitalized family member had a 73% greater incidence of CDI compared with enrollees who were not exposed. The longer the family member’s hospital stay, the greater the risk that someone in the household became infected.

Compared with people whose family members were hospitalized less than 1 day, people whose family members were hospitalized from 1 to 3 days had an incidence rate ratio (IRR) of 1.30 (95% confidence interval [CI], 1.19-1.41), and those whose family members were hospitalized for more than 30 days had an IRR of 2.45 (95% CI, 1.66-3.60).

CDI incidence increased with age. Compared with people 17 years of age or younger, the IRR increased to 9.32 (95% CI, 8.92-9.73) for those over 65.

Females had higher CDI incidence than males (IRR 1.30; 95% CI, 1.28-1.33).

Households with an infant also had higher CDI incidence than those without (IRR 1.5; 95% CI, 1.44-1.58).

People taking antimicrobials had higher CDI IRRs: 2.69 (95% CI, 2.59-2.79) for low-CDI-risk antibiotics and 8.83 (95% CI, 8.63-9.03) for high-CDI-risk antibiotics.

People taking proton-pump inhibitors had an IRR of 2.23 (95% CI, 2.15-2.30).
 

Reactions from four experts

Douglas S. Paauw MD, MACP, professor of medicine and the chair for patient-centered clinical education at the University of Washington, Seattle, was not surprised by the findings. “We have wondered for a while how community-acquired CDI occurs,” he said in an email. “This important study offers a plausible explanation for some cases.”

Dr. Paauw advises doctors to consider CDI in their patients who have been exposed to hospitalized people.

David M. Aronoff, MD, FIDSA, FAAM, professor of medicine and the chair of the department of medicine at Indiana University, Indianapolis, advises providers to educate hospital patients being discharged about how CDI is spread and how they can practice good hand hygiene at home.

“An open question of this strong study is whether we should be testing certain hospital patients for asymptomatic C. difficile carriage before they are discharged,” he added in an email.

In a phone interview, Paul G. Auwaerter, MD, MBA, professor of medicine and clinical director of the division of infectious diseases at Johns Hopkins University, Baltimore, noted that community-acquired CDI is frequent enough that his institution performs routine C. difficile testing on all patients with unexplained severe diarrhea.

“This intriguing study bears additional research and follow-up because clearly these spores are hardy,” he said. “But a key point in this billings- and claims-based study is that no one knows where household members acquired CDI, whether it was actually through household transmission.”

Ramin Asgary, MD, MPH, FASTMH, associate professor of global health in the Milken Institute School of Public Health at George Washington University, Washington, cautioned about “an increasing issue with drug-resistant CDI.

“This important, timely study provides another step in the right direction to better understanding and addressing CDI and other hospital-based infections that have become increasing threats to the safety of our patients, their families, and health care in general,” he said in an email.

Dr. Miller said that the scale and scope of the data are strengths of the study, and he acknowledged that its basis in claims and billing data is a limitation. He and his group plan to explore genetic relationships involved in CDI transmission.

The study was funded by the Centers for Disease Control and Prevention. All authors and independent experts have disclosed no relevant financial relationships.

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

At least one in four adults worldwide is thought to have nonalcoholic fatty liver disease, a major risk factor for cardiovascular disease (CVD), which is the leading cause of death in NAFLD, but the condition is widely underdiagnosed, according to a new American Heart Association scientific statement on NAFLD and cardiovascular risks.

The statement, published in Arteriosclerosis, Thrombosis, and Vascular Biology, aims to increase awareness of NAFLD among cardiologists and other clinicians treating vulnerable patients. It pulls together the existing evidence for using imaging to diagnose NAFLD as well as the role of current and emerging treatments for managing the disease.

“NAFLD is common, but most patients are undiagnosed,” statement writing committee chair P. Barton Duell, MD, said in an interview. “The identification of normal liver enzyme levels does not exclude the diagnosis of NAFLD. Early diagnosis and treatment are necessary to improve the health of patients with established NAFLD, as well as preventing the development of NAFLD in patients who are at risk for the condition.”

Dr. Duell is a professor at the Knight Cardiovascular Institute and division of endocrinology, diabetes and clinical nutrition at Oregon Health & Science University, Portland.

This is the AHA’s first scientific statement on NAFLD. In 2021, the association issued a statement on obesity and CVD). Also in 2021, a multiorganization group headed by the American Gastroenterological Association published a “Call to Action” on nonalcoholic steatohepatitis (NASH) , a form of NAFLD that’s characterized by inflammation and scarring of the liver, and typically requires a liver biopsy for diagnosis.

Key take-homes

The AHA statement on NAFLD is sweeping. Among its key take-home messages:

• Calling into question the effectiveness of AST and ALT testing for diagnosing NAFLD and NASH.
• Providing context to the role of insulin resistance – either with or without diabetes – as well as obesity (particularly visceral adiposity), metabolic syndrome, and dyslipidemia in NAFLD.
• Advocating for lifestyle interventions – diet, exercise, weight loss and alcohol avoidance – as the key therapeutic intervention for NAFLD.
• Asserting that glucagonlike peptide–1 receptor agonists may modestly improve NAFLD.

The statement also tackles the differences in terminology different organizations use to describe NAFLD. “The terminology section is important to ensure everyone is using the right terminology in assessing patients, as well as choosing appropriate treatment interventions,” Dr. Duell said.

The statement also explores genetic factors that can predispose people to NAFLD, Dr. Duell pointed out, and it goes into detail about strategies for screening NAFLD and NASH. “It is not possible to diagnose NAFLD without understanding the pros and cons of various screening modalities, as well as the lack of sensitivity of some tests for detection of NAFLD We hope this information will increase success in screening for and early identification of NAFLD.”

Dr. Duell explained the rationale for issuing the statement. “Rates of NAFLD are increasing worldwide in association with rising rates of elevated body mass index and the metabolic syndrome, but the condition is commonly undiagnosed,” he said. “This allows patients to experience progression of disease, leading to hepatic and cardiovascular complications.” 

Avoiding NAFLD risk factors along with early diagnosis and treatment “may have the potential to mitigate long-term complications from NAFLD,” Dr. Duell said.

“This is one of first times where we really look at cardiovascular risks associated with NAFLD and pinpoint the risk factors, the imaging tools that can be used for diagnosing fatty liver disease, and ultimately what potential treatments we can consider,” Tiffany M. Powell-Wiley, MD, MPH, author of the AHA statement on obesity and CV risk, said in an interview.

“NAFLD has not been at the forefront of  cardiologists’ minds, but this statement highlights the importance of liver fat as a fat depot,” said Dr. Powell-Wiley, chief of the Social Determinants of Obesity and Cardiovascular Risk Laboratory at the National Heart, Lung, and Blood Institute in Bethesda, Md.

“It does provide greater clarity for us as cardiologists, especially when thinking about what is required for diagnosis and ultimately how this relates to cardiovascular disease for people with fatty liver disease,” she said.

Dr. Duell and Dr. Powell-Wiley have no relevant relationships to disclose.


 

At least one in four adults worldwide is thought to have nonalcoholic fatty liver disease, a major risk factor for cardiovascular disease (CVD), which is the leading cause of death in NAFLD, but the condition is widely underdiagnosed, according to a new American Heart Association scientific statement on NAFLD and cardiovascular risks.

The statement, published in Arteriosclerosis, Thrombosis, and Vascular Biology, aims to increase awareness of NAFLD among cardiologists and other clinicians treating vulnerable patients. It pulls together the existing evidence for using imaging to diagnose NAFLD as well as the role of current and emerging treatments for managing the disease.

“NAFLD is common, but most patients are undiagnosed,” statement writing committee chair P. Barton Duell, MD, said in an interview. “The identification of normal liver enzyme levels does not exclude the diagnosis of NAFLD. Early diagnosis and treatment are necessary to improve the health of patients with established NAFLD, as well as preventing the development of NAFLD in patients who are at risk for the condition.”

Dr. Duell is a professor at the Knight Cardiovascular Institute and division of endocrinology, diabetes and clinical nutrition at Oregon Health & Science University, Portland.

This is the AHA’s first scientific statement on NAFLD. In 2021, the association issued a statement on obesity and CVD). Also in 2021, a multiorganization group headed by the American Gastroenterological Association published a “Call to Action” on nonalcoholic steatohepatitis (NASH) , a form of NAFLD that’s characterized by inflammation and scarring of the liver, and typically requires a liver biopsy for diagnosis.

Key take-homes

The AHA statement on NAFLD is sweeping. Among its key take-home messages:

• Calling into question the effectiveness of AST and ALT testing for diagnosing NAFLD and NASH.
• Providing context to the role of insulin resistance – either with or without diabetes – as well as obesity (particularly visceral adiposity), metabolic syndrome, and dyslipidemia in NAFLD.
• Advocating for lifestyle interventions – diet, exercise, weight loss and alcohol avoidance – as the key therapeutic intervention for NAFLD.
• Asserting that glucagonlike peptide–1 receptor agonists may modestly improve NAFLD.

The statement also tackles the differences in terminology different organizations use to describe NAFLD. “The terminology section is important to ensure everyone is using the right terminology in assessing patients, as well as choosing appropriate treatment interventions,” Dr. Duell said.

The statement also explores genetic factors that can predispose people to NAFLD, Dr. Duell pointed out, and it goes into detail about strategies for screening NAFLD and NASH. “It is not possible to diagnose NAFLD without understanding the pros and cons of various screening modalities, as well as the lack of sensitivity of some tests for detection of NAFLD We hope this information will increase success in screening for and early identification of NAFLD.”

Dr. Duell explained the rationale for issuing the statement. “Rates of NAFLD are increasing worldwide in association with rising rates of elevated body mass index and the metabolic syndrome, but the condition is commonly undiagnosed,” he said. “This allows patients to experience progression of disease, leading to hepatic and cardiovascular complications.” 

Avoiding NAFLD risk factors along with early diagnosis and treatment “may have the potential to mitigate long-term complications from NAFLD,” Dr. Duell said.

“This is one of first times where we really look at cardiovascular risks associated with NAFLD and pinpoint the risk factors, the imaging tools that can be used for diagnosing fatty liver disease, and ultimately what potential treatments we can consider,” Tiffany M. Powell-Wiley, MD, MPH, author of the AHA statement on obesity and CV risk, said in an interview.

“NAFLD has not been at the forefront of  cardiologists’ minds, but this statement highlights the importance of liver fat as a fat depot,” said Dr. Powell-Wiley, chief of the Social Determinants of Obesity and Cardiovascular Risk Laboratory at the National Heart, Lung, and Blood Institute in Bethesda, Md.

“It does provide greater clarity for us as cardiologists, especially when thinking about what is required for diagnosis and ultimately how this relates to cardiovascular disease for people with fatty liver disease,” she said.

Dr. Duell and Dr. Powell-Wiley have no relevant relationships to disclose.


 

At least one in four adults worldwide is thought to have nonalcoholic fatty liver disease, a major risk factor for cardiovascular disease (CVD), which is the leading cause of death in NAFLD, but the condition is widely underdiagnosed, according to a new American Heart Association scientific statement on NAFLD and cardiovascular risks.

The statement, published in Arteriosclerosis, Thrombosis, and Vascular Biology, aims to increase awareness of NAFLD among cardiologists and other clinicians treating vulnerable patients. It pulls together the existing evidence for using imaging to diagnose NAFLD as well as the role of current and emerging treatments for managing the disease.

“NAFLD is common, but most patients are undiagnosed,” statement writing committee chair P. Barton Duell, MD, said in an interview. “The identification of normal liver enzyme levels does not exclude the diagnosis of NAFLD. Early diagnosis and treatment are necessary to improve the health of patients with established NAFLD, as well as preventing the development of NAFLD in patients who are at risk for the condition.”

Dr. Duell is a professor at the Knight Cardiovascular Institute and division of endocrinology, diabetes and clinical nutrition at Oregon Health & Science University, Portland.

This is the AHA’s first scientific statement on NAFLD. In 2021, the association issued a statement on obesity and CVD). Also in 2021, a multiorganization group headed by the American Gastroenterological Association published a “Call to Action” on nonalcoholic steatohepatitis (NASH) , a form of NAFLD that’s characterized by inflammation and scarring of the liver, and typically requires a liver biopsy for diagnosis.

Key take-homes

The AHA statement on NAFLD is sweeping. Among its key take-home messages:

• Calling into question the effectiveness of AST and ALT testing for diagnosing NAFLD and NASH.
• Providing context to the role of insulin resistance – either with or without diabetes – as well as obesity (particularly visceral adiposity), metabolic syndrome, and dyslipidemia in NAFLD.
• Advocating for lifestyle interventions – diet, exercise, weight loss and alcohol avoidance – as the key therapeutic intervention for NAFLD.
• Asserting that glucagonlike peptide–1 receptor agonists may modestly improve NAFLD.

The statement also tackles the differences in terminology different organizations use to describe NAFLD. “The terminology section is important to ensure everyone is using the right terminology in assessing patients, as well as choosing appropriate treatment interventions,” Dr. Duell said.

The statement also explores genetic factors that can predispose people to NAFLD, Dr. Duell pointed out, and it goes into detail about strategies for screening NAFLD and NASH. “It is not possible to diagnose NAFLD without understanding the pros and cons of various screening modalities, as well as the lack of sensitivity of some tests for detection of NAFLD We hope this information will increase success in screening for and early identification of NAFLD.”

Dr. Duell explained the rationale for issuing the statement. “Rates of NAFLD are increasing worldwide in association with rising rates of elevated body mass index and the metabolic syndrome, but the condition is commonly undiagnosed,” he said. “This allows patients to experience progression of disease, leading to hepatic and cardiovascular complications.” 

Avoiding NAFLD risk factors along with early diagnosis and treatment “may have the potential to mitigate long-term complications from NAFLD,” Dr. Duell said.

“This is one of first times where we really look at cardiovascular risks associated with NAFLD and pinpoint the risk factors, the imaging tools that can be used for diagnosing fatty liver disease, and ultimately what potential treatments we can consider,” Tiffany M. Powell-Wiley, MD, MPH, author of the AHA statement on obesity and CV risk, said in an interview.

“NAFLD has not been at the forefront of  cardiologists’ minds, but this statement highlights the importance of liver fat as a fat depot,” said Dr. Powell-Wiley, chief of the Social Determinants of Obesity and Cardiovascular Risk Laboratory at the National Heart, Lung, and Blood Institute in Bethesda, Md.

“It does provide greater clarity for us as cardiologists, especially when thinking about what is required for diagnosis and ultimately how this relates to cardiovascular disease for people with fatty liver disease,” she said.

Dr. Duell and Dr. Powell-Wiley have no relevant relationships to disclose.


 

New data from two different sources on cardiac complications linked to COVID-19 have shown that such issues are low overall but are higher after infection than after vaccination.

The new information comes from the Centers for Disease Control and Prevention’s National Patient-Centered Clinical Research Network (PCORnet) and from a separate large international clinical study published online in Circulation.
 

CDC data

The CDC study analyzed electronic health record data from 40 U.S. health care systems from Jan. 1, 2021, to Jan. 31, 2022, on more than 15 million people aged 5 years or older.

It reports a rate of myocarditis or pericarditis after mRNA COVID-19 vaccination of 0-35.9 per 100,000 for males and 0-10.9 per 100,000 for females across different age groups and vaccine cohorts.

Rates of myocarditis or pericarditis after SARS-CoV-2 infection ranged from 12.6 to 114 per 100,000 for males and from 5.4 to 61.7 per 100,000 for females across different age groups.  

Even among males aged 12-17 years, the group with the highest incidence of cardiac complications after receipt of a second mRNA COVID-19 vaccine dose, the risk was 1.8-5.6 times higher after SARS-CoV-2 infection than after vaccination, the CDC report notes.

“These findings provide important context for balancing risks and benefits of mRNA COVID-19 vaccination among eligible persons greater than or equal to 5 years,” the report states. They also “support the continued use of recommended mRNA vaccines among all eligible persons aged greater than or equal to 5 years,” it concludes.
 

International study

The international study focused on prevalence, clinical characteristics, and outcomes of clinically manifest acute myocarditis in patients with COVID-19 infection.

The study showed a rate of acute myocarditis of 2.4 per 1,000 patients hospitalized with COVID-19.

“A small study previously indicated acute myocarditis is a rare occurrence in people infected with COVID-19. Our analysis of international data offers better insight to the occurrence of acute myocarditis during COVID-19 hospitalization, particularly before the COVID-19 vaccines were widely available,” coauthor Enrico Ammirati, MD, PhD, Niguarda Hospital, Milan, commented.

“This analysis indicates that, although rare, hospitalized patients with acute myocarditis associated with COVID-19 infection have a much greater need for intensive care unit admission, in up to 70.5% of the cases, despite the average age of the individuals in the study being much younger than expected, at 38 years old,” added coauthor Marco Metra, MD, University of Brescia, Italy. 

The researchers report that the use of corticosteroids in patients with acute myocarditis appeared safe, and, in most cases, a rapid increase in the left ventricular ejection fraction was observed. In addition, they say that discharged patients with acute myocarditis had “an excellent short-term prognosis without occurrence of cardiovascular events.”

The authors also point out that these data show much higher frequency and severity of acute myocarditis linked to COVID-19 infection, compared with myocarditis cases linked to the mRNA COVID-19 vaccines.

The international study examined health data on 56,963 patients who were hospitalized with COVID-19 at 23 hospitals across the United States and Europe from February 2020 through April 2021. 

Among these patients, 97 with possible acute myocarditis were identified (4.1 per 1,000), of whom 54 (2.4 per 1,000) were classified as having “definite or probable” acute myocarditis supported by endomyocardial biopsy (31.5% of cases) or magnetic resonance imaging (92.6% of cases).

The median age of definite/probable acute myocarditis cases was 38 years, and 39% were female. On admission, chest pain and dyspnea were the most frequent symptoms (55.5% and 53.7%, respectively), and 31 cases (57.4%) occurred in the absence of COVID-19–associated pneumonia. A fulminant presentation requiring inotropic support or temporary mechanical circulatory support occurred in 21 cases (39%).

Overall, 38 patients (70.4%) were admitted to the intensive care unit for a median time of 6 days. Ten patients (18.5%) received temporary mechanical circulatory support for a median time of 5 days. Three patients died (5.5%) during the index hospitalization, all of whom also had pneumonia. At 120 days, estimated mortality was 6.6%. Patients with pneumonia were more likely to develop hemodynamic instability, require mechanical circulatory support, and die, compared with those without pneumonia.

The authors note that their reported prevalence of acute myocarditis associated with COVID-19 is lower, compared with studies that performed universal cardiac MRI screening during the convalescent COVID-19 period.

They say that underestimation of the prevalence of mild or subclinical acute myocarditis is likely in this study because of the retrospective nature of the registry, the lack of systematic cardiac MRI, and the possibility of missing some diagnoses, particularly during the first pandemic wave when cardiac MRI and endomyocardial biopsy were less frequently performed.

The authors also point out that data on myocarditis after COVID-19 vaccination suggest that vaccination-linked myocarditis is milder than that associated with the virus itself.

With regard to the prevalence of acute myocarditis after vaccination, they report that among 2.8 million doses of mRNA COVID-19 vaccine in the armed forces, 23 individuals had evidence of acute myocarditis, suggesting a prevalence of less than 1 case of acute myocarditis per 100,000 mRNA COVID-19 vaccine doses.

They note that the CDC has also reported 399 reports of myocarditis among 129 million fully vaccinated individuals with the mRNA COVID-19 vaccines.

“These figures appear reassuring, compared with the prevalence of clinically manifest acute myocarditis observed in this study among hospitalized patients with COVID-19,” they conclude.

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

New data from two different sources on cardiac complications linked to COVID-19 have shown that such issues are low overall but are higher after infection than after vaccination.

The new information comes from the Centers for Disease Control and Prevention’s National Patient-Centered Clinical Research Network (PCORnet) and from a separate large international clinical study published online in Circulation.
 

CDC data

The CDC study analyzed electronic health record data from 40 U.S. health care systems from Jan. 1, 2021, to Jan. 31, 2022, on more than 15 million people aged 5 years or older.

It reports a rate of myocarditis or pericarditis after mRNA COVID-19 vaccination of 0-35.9 per 100,000 for males and 0-10.9 per 100,000 for females across different age groups and vaccine cohorts.

Rates of myocarditis or pericarditis after SARS-CoV-2 infection ranged from 12.6 to 114 per 100,000 for males and from 5.4 to 61.7 per 100,000 for females across different age groups.  

Even among males aged 12-17 years, the group with the highest incidence of cardiac complications after receipt of a second mRNA COVID-19 vaccine dose, the risk was 1.8-5.6 times higher after SARS-CoV-2 infection than after vaccination, the CDC report notes.

“These findings provide important context for balancing risks and benefits of mRNA COVID-19 vaccination among eligible persons greater than or equal to 5 years,” the report states. They also “support the continued use of recommended mRNA vaccines among all eligible persons aged greater than or equal to 5 years,” it concludes.
 

International study

The international study focused on prevalence, clinical characteristics, and outcomes of clinically manifest acute myocarditis in patients with COVID-19 infection.

The study showed a rate of acute myocarditis of 2.4 per 1,000 patients hospitalized with COVID-19.

“A small study previously indicated acute myocarditis is a rare occurrence in people infected with COVID-19. Our analysis of international data offers better insight to the occurrence of acute myocarditis during COVID-19 hospitalization, particularly before the COVID-19 vaccines were widely available,” coauthor Enrico Ammirati, MD, PhD, Niguarda Hospital, Milan, commented.

“This analysis indicates that, although rare, hospitalized patients with acute myocarditis associated with COVID-19 infection have a much greater need for intensive care unit admission, in up to 70.5% of the cases, despite the average age of the individuals in the study being much younger than expected, at 38 years old,” added coauthor Marco Metra, MD, University of Brescia, Italy. 

The researchers report that the use of corticosteroids in patients with acute myocarditis appeared safe, and, in most cases, a rapid increase in the left ventricular ejection fraction was observed. In addition, they say that discharged patients with acute myocarditis had “an excellent short-term prognosis without occurrence of cardiovascular events.”

The authors also point out that these data show much higher frequency and severity of acute myocarditis linked to COVID-19 infection, compared with myocarditis cases linked to the mRNA COVID-19 vaccines.

The international study examined health data on 56,963 patients who were hospitalized with COVID-19 at 23 hospitals across the United States and Europe from February 2020 through April 2021. 

Among these patients, 97 with possible acute myocarditis were identified (4.1 per 1,000), of whom 54 (2.4 per 1,000) were classified as having “definite or probable” acute myocarditis supported by endomyocardial biopsy (31.5% of cases) or magnetic resonance imaging (92.6% of cases).

The median age of definite/probable acute myocarditis cases was 38 years, and 39% were female. On admission, chest pain and dyspnea were the most frequent symptoms (55.5% and 53.7%, respectively), and 31 cases (57.4%) occurred in the absence of COVID-19–associated pneumonia. A fulminant presentation requiring inotropic support or temporary mechanical circulatory support occurred in 21 cases (39%).

Overall, 38 patients (70.4%) were admitted to the intensive care unit for a median time of 6 days. Ten patients (18.5%) received temporary mechanical circulatory support for a median time of 5 days. Three patients died (5.5%) during the index hospitalization, all of whom also had pneumonia. At 120 days, estimated mortality was 6.6%. Patients with pneumonia were more likely to develop hemodynamic instability, require mechanical circulatory support, and die, compared with those without pneumonia.

The authors note that their reported prevalence of acute myocarditis associated with COVID-19 is lower, compared with studies that performed universal cardiac MRI screening during the convalescent COVID-19 period.

They say that underestimation of the prevalence of mild or subclinical acute myocarditis is likely in this study because of the retrospective nature of the registry, the lack of systematic cardiac MRI, and the possibility of missing some diagnoses, particularly during the first pandemic wave when cardiac MRI and endomyocardial biopsy were less frequently performed.

The authors also point out that data on myocarditis after COVID-19 vaccination suggest that vaccination-linked myocarditis is milder than that associated with the virus itself.

With regard to the prevalence of acute myocarditis after vaccination, they report that among 2.8 million doses of mRNA COVID-19 vaccine in the armed forces, 23 individuals had evidence of acute myocarditis, suggesting a prevalence of less than 1 case of acute myocarditis per 100,000 mRNA COVID-19 vaccine doses.

They note that the CDC has also reported 399 reports of myocarditis among 129 million fully vaccinated individuals with the mRNA COVID-19 vaccines.

“These figures appear reassuring, compared with the prevalence of clinically manifest acute myocarditis observed in this study among hospitalized patients with COVID-19,” they conclude.

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

New data from two different sources on cardiac complications linked to COVID-19 have shown that such issues are low overall but are higher after infection than after vaccination.

The new information comes from the Centers for Disease Control and Prevention’s National Patient-Centered Clinical Research Network (PCORnet) and from a separate large international clinical study published online in Circulation.
 

CDC data

The CDC study analyzed electronic health record data from 40 U.S. health care systems from Jan. 1, 2021, to Jan. 31, 2022, on more than 15 million people aged 5 years or older.

It reports a rate of myocarditis or pericarditis after mRNA COVID-19 vaccination of 0-35.9 per 100,000 for males and 0-10.9 per 100,000 for females across different age groups and vaccine cohorts.

Rates of myocarditis or pericarditis after SARS-CoV-2 infection ranged from 12.6 to 114 per 100,000 for males and from 5.4 to 61.7 per 100,000 for females across different age groups.  

Even among males aged 12-17 years, the group with the highest incidence of cardiac complications after receipt of a second mRNA COVID-19 vaccine dose, the risk was 1.8-5.6 times higher after SARS-CoV-2 infection than after vaccination, the CDC report notes.

“These findings provide important context for balancing risks and benefits of mRNA COVID-19 vaccination among eligible persons greater than or equal to 5 years,” the report states. They also “support the continued use of recommended mRNA vaccines among all eligible persons aged greater than or equal to 5 years,” it concludes.
 

International study

The international study focused on prevalence, clinical characteristics, and outcomes of clinically manifest acute myocarditis in patients with COVID-19 infection.

The study showed a rate of acute myocarditis of 2.4 per 1,000 patients hospitalized with COVID-19.

“A small study previously indicated acute myocarditis is a rare occurrence in people infected with COVID-19. Our analysis of international data offers better insight to the occurrence of acute myocarditis during COVID-19 hospitalization, particularly before the COVID-19 vaccines were widely available,” coauthor Enrico Ammirati, MD, PhD, Niguarda Hospital, Milan, commented.

“This analysis indicates that, although rare, hospitalized patients with acute myocarditis associated with COVID-19 infection have a much greater need for intensive care unit admission, in up to 70.5% of the cases, despite the average age of the individuals in the study being much younger than expected, at 38 years old,” added coauthor Marco Metra, MD, University of Brescia, Italy. 

The researchers report that the use of corticosteroids in patients with acute myocarditis appeared safe, and, in most cases, a rapid increase in the left ventricular ejection fraction was observed. In addition, they say that discharged patients with acute myocarditis had “an excellent short-term prognosis without occurrence of cardiovascular events.”

The authors also point out that these data show much higher frequency and severity of acute myocarditis linked to COVID-19 infection, compared with myocarditis cases linked to the mRNA COVID-19 vaccines.

The international study examined health data on 56,963 patients who were hospitalized with COVID-19 at 23 hospitals across the United States and Europe from February 2020 through April 2021. 

Among these patients, 97 with possible acute myocarditis were identified (4.1 per 1,000), of whom 54 (2.4 per 1,000) were classified as having “definite or probable” acute myocarditis supported by endomyocardial biopsy (31.5% of cases) or magnetic resonance imaging (92.6% of cases).

The median age of definite/probable acute myocarditis cases was 38 years, and 39% were female. On admission, chest pain and dyspnea were the most frequent symptoms (55.5% and 53.7%, respectively), and 31 cases (57.4%) occurred in the absence of COVID-19–associated pneumonia. A fulminant presentation requiring inotropic support or temporary mechanical circulatory support occurred in 21 cases (39%).

Overall, 38 patients (70.4%) were admitted to the intensive care unit for a median time of 6 days. Ten patients (18.5%) received temporary mechanical circulatory support for a median time of 5 days. Three patients died (5.5%) during the index hospitalization, all of whom also had pneumonia. At 120 days, estimated mortality was 6.6%. Patients with pneumonia were more likely to develop hemodynamic instability, require mechanical circulatory support, and die, compared with those without pneumonia.

The authors note that their reported prevalence of acute myocarditis associated with COVID-19 is lower, compared with studies that performed universal cardiac MRI screening during the convalescent COVID-19 period.

They say that underestimation of the prevalence of mild or subclinical acute myocarditis is likely in this study because of the retrospective nature of the registry, the lack of systematic cardiac MRI, and the possibility of missing some diagnoses, particularly during the first pandemic wave when cardiac MRI and endomyocardial biopsy were less frequently performed.

The authors also point out that data on myocarditis after COVID-19 vaccination suggest that vaccination-linked myocarditis is milder than that associated with the virus itself.

With regard to the prevalence of acute myocarditis after vaccination, they report that among 2.8 million doses of mRNA COVID-19 vaccine in the armed forces, 23 individuals had evidence of acute myocarditis, suggesting a prevalence of less than 1 case of acute myocarditis per 100,000 mRNA COVID-19 vaccine doses.

They note that the CDC has also reported 399 reports of myocarditis among 129 million fully vaccinated individuals with the mRNA COVID-19 vaccines.

“These figures appear reassuring, compared with the prevalence of clinically manifest acute myocarditis observed in this study among hospitalized patients with COVID-19,” they conclude.

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

A fourth dose of the Pfizer-BioNTech vaccine is effective in reducing the short-term risk for COVID-19 infection, hospitalization, and death in people who got a third dose at least 4 months before, a large study shows.

However, Paul Offit, MD, author of an editorial accompanying the study, told this news organization, “I would argue, without fear of contradiction, that this is going to have no impact on this pandemic.”

“We are still in the midst of a zero-tolerance policy for this virus. We don’t accept mild illness and if we’re not going to accept mild illness, we think we have to boost it away, which would mean probably about two doses every year. That’s not a reasonable public health strategy,” said Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
 

Booster confusion

Results of the research out of Israel, published in the New England Journal of Medicine, make a case for a fourth booster for people 60 and over.

Researchers, led by Ori Magen, MD, Clalit Research Institute, innovation division, Clalit Health Services, Tel Aviv, analyzed data comparing 182,122 matched pairs recorded by the largest health care organization in Israel from Jan. 3 to Feb. 18, 2022. With more than 4.7 million members, Clalit Health Services covers more than half of the population of Israel.

The researchers compared outcomes in people 60 or older (average age, 72 years) who got a fourth dose with outcomes in those who had only a third dose. They individually matched people from the two groups, considering factors such as age, health status, and ethnicity.

Relative vaccine effectiveness in days 7-30 after the fourth dose was estimated to be 45% (95% confidence interval, 44%-47%) against confirmed SARS-CoV-2 infection, 55% (95% CI, 53%-58%) against symptomatic COVID-19, 68% (95% CI, 59%-74%) against hospitalization, 62% (95% CI, 50%-74%) against severe COVID, and 74% (95% CI, 50%-90%) against COVID-related death.

Several countries, including the United States, have begun offering a fourth vaccine dose for higher-risk populations in light of evidence of waning immunity after the third dose and waves of infection, driven by Omicron and its variants, in some parts of the world. But the recommended age groups differ considerably.

In the United States, for instance, the Food and Drug Administration in late March approved a fourth dose of the Pfizer or Moderna vaccine for anyone over 50 and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk.

Dr. Offit pointed out that Israel offers the fourth vaccine for people 60 and over and the European Medical Association offers it for those over 80. No surprise that confusion over the fourth dose is rampant.
 

Booster advice

Dr. Offit offered this perspective: People who are immunocompromised could reasonably get a fourth dose, depending on the manner in which they are compromised.

“Someone who has a solid organ transplant is not the same as someone who is getting a monoclonal antibody for their rheumatoid arthritis,” Dr. Offit said, adding that people could also make a reasonable argument for the fourth dose if they are over 65 and have multiple comorbidities.

“I’m over 65,” Dr. Offit said. “I’m generally healthy. I’m not going to get a fourth dose.”

People with multiple comorbidities over age 12 could reasonably get a third dose, he said. “For everybody else – healthy people less than 65 – I would argue this is a two-dose vaccine.”

CHOP, he noted as an example, mandates the vaccine but doesn’t mandate three doses and he says that’s not unusual for hospital systems.

“How many lives are you really saving with that fourth dose? If you really want to have an effect on this pandemic, vaccinate the unvaccinated,” Dr. Offit said.
 

Focus on the memory cells

Dr. Offit wrote in the editorial: “Arguably, the most disappointing error surrounding the use of COVID-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as ‘breakthroughs.’ As is true for all mucosal vaccines, the goal is to protect against serious illness – to keep people out of the hospital, intensive care unit, and morgue. The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus.”

Dr. Offit said that the focus should be on the memory cells, not the neutralizing antibodies.

Regarding mRNA vaccines, Dr. Offit said “the surprise of this vaccine – it surprised me and other vaccine researchers – is that with these two doses of mRNA separated by 3-4 weeks, you actually appear to have long-lived memory response.

“That’s not the history of vaccines. If you look at the inactivated polio vaccine or the inactivated hepatitis A vaccine, you really do need a 4- to 6-month interval between doses to get high frequencies of memory cells. That doesn’t appear to be the case here. It looks like two doses given close together do just that. Memory cells last for years if not, sometimes, decades.”

Neutralizing antibodies, on the other hand, protect against mild illness and their effectiveness wanes after months.

“At some point we are going to have to get used to mild illness,” Dr. Offit said.

The Centers for Disease Control and Prevention must now determine who will benefit most from booster dosing and educate the public about the limits of mucosal vaccines, Dr. Offit wrote in the editorial.

“Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what COVID-19 vaccines can and cannot do.”

The work was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.

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

A fourth dose of the Pfizer-BioNTech vaccine is effective in reducing the short-term risk for COVID-19 infection, hospitalization, and death in people who got a third dose at least 4 months before, a large study shows.

However, Paul Offit, MD, author of an editorial accompanying the study, told this news organization, “I would argue, without fear of contradiction, that this is going to have no impact on this pandemic.”

“We are still in the midst of a zero-tolerance policy for this virus. We don’t accept mild illness and if we’re not going to accept mild illness, we think we have to boost it away, which would mean probably about two doses every year. That’s not a reasonable public health strategy,” said Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
 

Booster confusion

Results of the research out of Israel, published in the New England Journal of Medicine, make a case for a fourth booster for people 60 and over.

Researchers, led by Ori Magen, MD, Clalit Research Institute, innovation division, Clalit Health Services, Tel Aviv, analyzed data comparing 182,122 matched pairs recorded by the largest health care organization in Israel from Jan. 3 to Feb. 18, 2022. With more than 4.7 million members, Clalit Health Services covers more than half of the population of Israel.

The researchers compared outcomes in people 60 or older (average age, 72 years) who got a fourth dose with outcomes in those who had only a third dose. They individually matched people from the two groups, considering factors such as age, health status, and ethnicity.

Relative vaccine effectiveness in days 7-30 after the fourth dose was estimated to be 45% (95% confidence interval, 44%-47%) against confirmed SARS-CoV-2 infection, 55% (95% CI, 53%-58%) against symptomatic COVID-19, 68% (95% CI, 59%-74%) against hospitalization, 62% (95% CI, 50%-74%) against severe COVID, and 74% (95% CI, 50%-90%) against COVID-related death.

Several countries, including the United States, have begun offering a fourth vaccine dose for higher-risk populations in light of evidence of waning immunity after the third dose and waves of infection, driven by Omicron and its variants, in some parts of the world. But the recommended age groups differ considerably.

In the United States, for instance, the Food and Drug Administration in late March approved a fourth dose of the Pfizer or Moderna vaccine for anyone over 50 and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk.

Dr. Offit pointed out that Israel offers the fourth vaccine for people 60 and over and the European Medical Association offers it for those over 80. No surprise that confusion over the fourth dose is rampant.
 

Booster advice

Dr. Offit offered this perspective: People who are immunocompromised could reasonably get a fourth dose, depending on the manner in which they are compromised.

“Someone who has a solid organ transplant is not the same as someone who is getting a monoclonal antibody for their rheumatoid arthritis,” Dr. Offit said, adding that people could also make a reasonable argument for the fourth dose if they are over 65 and have multiple comorbidities.

“I’m over 65,” Dr. Offit said. “I’m generally healthy. I’m not going to get a fourth dose.”

People with multiple comorbidities over age 12 could reasonably get a third dose, he said. “For everybody else – healthy people less than 65 – I would argue this is a two-dose vaccine.”

CHOP, he noted as an example, mandates the vaccine but doesn’t mandate three doses and he says that’s not unusual for hospital systems.

“How many lives are you really saving with that fourth dose? If you really want to have an effect on this pandemic, vaccinate the unvaccinated,” Dr. Offit said.
 

Focus on the memory cells

Dr. Offit wrote in the editorial: “Arguably, the most disappointing error surrounding the use of COVID-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as ‘breakthroughs.’ As is true for all mucosal vaccines, the goal is to protect against serious illness – to keep people out of the hospital, intensive care unit, and morgue. The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus.”

Dr. Offit said that the focus should be on the memory cells, not the neutralizing antibodies.

Regarding mRNA vaccines, Dr. Offit said “the surprise of this vaccine – it surprised me and other vaccine researchers – is that with these two doses of mRNA separated by 3-4 weeks, you actually appear to have long-lived memory response.

“That’s not the history of vaccines. If you look at the inactivated polio vaccine or the inactivated hepatitis A vaccine, you really do need a 4- to 6-month interval between doses to get high frequencies of memory cells. That doesn’t appear to be the case here. It looks like two doses given close together do just that. Memory cells last for years if not, sometimes, decades.”

Neutralizing antibodies, on the other hand, protect against mild illness and their effectiveness wanes after months.

“At some point we are going to have to get used to mild illness,” Dr. Offit said.

The Centers for Disease Control and Prevention must now determine who will benefit most from booster dosing and educate the public about the limits of mucosal vaccines, Dr. Offit wrote in the editorial.

“Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what COVID-19 vaccines can and cannot do.”

The work was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.

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

A fourth dose of the Pfizer-BioNTech vaccine is effective in reducing the short-term risk for COVID-19 infection, hospitalization, and death in people who got a third dose at least 4 months before, a large study shows.

However, Paul Offit, MD, author of an editorial accompanying the study, told this news organization, “I would argue, without fear of contradiction, that this is going to have no impact on this pandemic.”

“We are still in the midst of a zero-tolerance policy for this virus. We don’t accept mild illness and if we’re not going to accept mild illness, we think we have to boost it away, which would mean probably about two doses every year. That’s not a reasonable public health strategy,” said Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
 

Booster confusion

Results of the research out of Israel, published in the New England Journal of Medicine, make a case for a fourth booster for people 60 and over.

Researchers, led by Ori Magen, MD, Clalit Research Institute, innovation division, Clalit Health Services, Tel Aviv, analyzed data comparing 182,122 matched pairs recorded by the largest health care organization in Israel from Jan. 3 to Feb. 18, 2022. With more than 4.7 million members, Clalit Health Services covers more than half of the population of Israel.

The researchers compared outcomes in people 60 or older (average age, 72 years) who got a fourth dose with outcomes in those who had only a third dose. They individually matched people from the two groups, considering factors such as age, health status, and ethnicity.

Relative vaccine effectiveness in days 7-30 after the fourth dose was estimated to be 45% (95% confidence interval, 44%-47%) against confirmed SARS-CoV-2 infection, 55% (95% CI, 53%-58%) against symptomatic COVID-19, 68% (95% CI, 59%-74%) against hospitalization, 62% (95% CI, 50%-74%) against severe COVID, and 74% (95% CI, 50%-90%) against COVID-related death.

Several countries, including the United States, have begun offering a fourth vaccine dose for higher-risk populations in light of evidence of waning immunity after the third dose and waves of infection, driven by Omicron and its variants, in some parts of the world. But the recommended age groups differ considerably.

In the United States, for instance, the Food and Drug Administration in late March approved a fourth dose of the Pfizer or Moderna vaccine for anyone over 50 and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk.

Dr. Offit pointed out that Israel offers the fourth vaccine for people 60 and over and the European Medical Association offers it for those over 80. No surprise that confusion over the fourth dose is rampant.
 

Booster advice

Dr. Offit offered this perspective: People who are immunocompromised could reasonably get a fourth dose, depending on the manner in which they are compromised.

“Someone who has a solid organ transplant is not the same as someone who is getting a monoclonal antibody for their rheumatoid arthritis,” Dr. Offit said, adding that people could also make a reasonable argument for the fourth dose if they are over 65 and have multiple comorbidities.

“I’m over 65,” Dr. Offit said. “I’m generally healthy. I’m not going to get a fourth dose.”

People with multiple comorbidities over age 12 could reasonably get a third dose, he said. “For everybody else – healthy people less than 65 – I would argue this is a two-dose vaccine.”

CHOP, he noted as an example, mandates the vaccine but doesn’t mandate three doses and he says that’s not unusual for hospital systems.

“How many lives are you really saving with that fourth dose? If you really want to have an effect on this pandemic, vaccinate the unvaccinated,” Dr. Offit said.
 

Focus on the memory cells

Dr. Offit wrote in the editorial: “Arguably, the most disappointing error surrounding the use of COVID-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as ‘breakthroughs.’ As is true for all mucosal vaccines, the goal is to protect against serious illness – to keep people out of the hospital, intensive care unit, and morgue. The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus.”

Dr. Offit said that the focus should be on the memory cells, not the neutralizing antibodies.

Regarding mRNA vaccines, Dr. Offit said “the surprise of this vaccine – it surprised me and other vaccine researchers – is that with these two doses of mRNA separated by 3-4 weeks, you actually appear to have long-lived memory response.

“That’s not the history of vaccines. If you look at the inactivated polio vaccine or the inactivated hepatitis A vaccine, you really do need a 4- to 6-month interval between doses to get high frequencies of memory cells. That doesn’t appear to be the case here. It looks like two doses given close together do just that. Memory cells last for years if not, sometimes, decades.”

Neutralizing antibodies, on the other hand, protect against mild illness and their effectiveness wanes after months.

“At some point we are going to have to get used to mild illness,” Dr. Offit said.

The Centers for Disease Control and Prevention must now determine who will benefit most from booster dosing and educate the public about the limits of mucosal vaccines, Dr. Offit wrote in the editorial.

“Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what COVID-19 vaccines can and cannot do.”

The work was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.

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

A jury last month found in favor of a West Virginia man who was permanently paralyzed following spinal cord surgery, according to a report by WOWK13 News, a local CBS affiliate in Huntington and Charleston, W. Va., among other news outlets.

On or about June 4, 2017, Michael Rodgers sustained injuries while riding his motorcycle. Admitted to Charleston Area Medical Center’s (CAMC’s) Level I trauma center, he initially showed no neurologic impairment and was able to feel and move all his extremities. A subsequent CT scan revealed, though, that he had incurred a T5 Chance fracture, as his later complaint states.

On June 6, a neurosurgeon affiliated with CAMC, John Orphanos, MD, instructed Mr. Rodgers to wear a back brace for 6 to 8 weeks. Later that day, though, Dr. Orphanos changed his course of treatment and recommended that Mr. Rodgers undergo surgery to treat his injuries. Despite his new recommendation, the neurosurgeon/spine specialist didn’t order a presurgical MRI of his patient’s thoracic spine. Typically, such a scan would have been used to determine any existing or potential spinal cord problems and any soft-tissue problems in the area of the fracture.

Not having such information, Dr. Orphanos was unaware that his patient had “an abundance of epidural fat, cord compression, cord edema, spinal abnormality, and spinal cord injury,” the complaint states. The neurosurgeon’s operative plan, therefore, included neither decompression of the spinal column nor use of neurophysiologic intraoperative monitoring, which is used to gauge, in real time during procedures, both how fast and how strongly a patient’s nerves are carrying signals.

Late on June 6, Dr. Orphanos performed a surgery to fuse his patient’s vertebrae from the T2 to the T6 region. Following the procedure, however, Mr. Rodgers experienced a complete loss of motor function and sensation in his lower extremities. A postoperative MRI proved inconclusive because of certain distorting effects of hardware implanted during the original surgery. Had a CT myelogram been ordered, it would have yielded a more accurate picture, the plaintiff alleged in his complaint.

Mr. Rodgers underwent a second surgery, during which Dr. Orphanos performed a T5 laminectomy. The patient’s loss of motor function and sensation persisted, however. He has been experiencing T5-level paraplegia ever since, with complete loss of control of his legs, bowel, and bladder.

In his complaint, Mr. Rodgers alleged that Dr. Orphanos had repeatedly deviated from the standard of care. Among other things, the plaintiff claimed, Dr. Orphanos had failed in both of his surgeries to order the proper preop and postop testing, thereby jeopardizing the outcomes of each procedure. This gross negligence and recklessness, the plaintiff argued, led directly to his permanent and disabling injuries.

Late last month, a West Virginia jury agreed that Dr. Orphanos was at fault and awarded Mr. Rodgers $17 million in damages.

Commented one of the pair of attorneys representing Mr. Rodgers: “We are very grateful to the jury, who saw through the attempts to rationalize the defendant’s conduct and delivered a jury verdict that will take care of Mr. Rodgers and provide the services he will need.”
 

Provider-to-provider disputes not time sensitive, state high court says

Early last month, Indiana’s high court ruled that the state’s med-mal statute of limitations doesn’t apply to disputes between providers, as a story in Radiology Business and other news sites reports.

The legal wrangling dates to April 2011. At that time, Joseph Shaughnessy underwent two CT scans at a Franciscan Alliance hospital, part of a healthcare system run by Franciscan Health. Outside radiologists from Lake Imaging read the scans, but they allegedly failed to note bleeding on the right side of the patient’s brain. Mr. Shaughnessy subsequently died, and his family filed suit against Franciscan, on the assumption that the radiologists were employees.

In 2015, the plaintiffs and Franciscan reached a $187,000 settlement, but Franciscan claimed it wasn’t liable for the payment, citing a clause in its prior agreement with Lake Imaging that protected it. But Lake Imaging sought to dismiss the Franciscan claim, arguing that the hospital system had failed to bring its suit within the state’s 2-year med-mal statute of limitations.

In its review of the case, the Indiana Supreme Court dismissed this argument: “(T)here is nothing in the [Medical Malpractice Act] to suggest that it extends beyond the physician-patient relationship to encompass commercial contracts between healthcare providers.”

In other words, while Indiana law places a 2-year limit on patients suing a hospital, doctor, or other healthcare professional, it places no such limit on contractually bound providers who take steps to sue each other.

As part of its unanimous decision, the high court also sent a claim by Lake Imaging against its insurance provider back to the trial court. The claim asks the insurance carrier — and not Lake Imaging — to assume responsibility for the settlement between Mr. Shaughnessy and Franciscan Alliance.

There was no word at press time as to when further legal proceedings would take place.
 

Paralyzed patient seeks millions

An Oregon man who was left paralyzed after undergoing surgery to address issues in his leg and foot has filed a large claim against both the hospital and surgical group involved in the procedure, details a story first reported by the Associated Press and picked up by other news outlets, including Fox12 Oregon.

On January 8, 2020, the man underwent brain surgery to address numbness in his left foot and a “vague” pain in his left leg. During the procedure, he experienced a dural tear, which the lead surgeon and his team addressed.

The following day, the man’s condition deteriorated, and he complained of severe pain, according to his lawsuit. Two days after his initial procedure, another surgeon performed a second procedure “to drain fluid and relieve pressure” on the patient’s brain. Nevertheless, the patient neither recovered sensation in his lower extremities nor use of his legs.

His claim against the facility and surgical practice asks for $43.5 million in damages for his injuries. For its part, the hospital expressed “deep compassion” for the patient and his family while making it clear that it believes its “caregivers provided excellent care.”

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

A jury last month found in favor of a West Virginia man who was permanently paralyzed following spinal cord surgery, according to a report by WOWK13 News, a local CBS affiliate in Huntington and Charleston, W. Va., among other news outlets.

On or about June 4, 2017, Michael Rodgers sustained injuries while riding his motorcycle. Admitted to Charleston Area Medical Center’s (CAMC’s) Level I trauma center, he initially showed no neurologic impairment and was able to feel and move all his extremities. A subsequent CT scan revealed, though, that he had incurred a T5 Chance fracture, as his later complaint states.

On June 6, a neurosurgeon affiliated with CAMC, John Orphanos, MD, instructed Mr. Rodgers to wear a back brace for 6 to 8 weeks. Later that day, though, Dr. Orphanos changed his course of treatment and recommended that Mr. Rodgers undergo surgery to treat his injuries. Despite his new recommendation, the neurosurgeon/spine specialist didn’t order a presurgical MRI of his patient’s thoracic spine. Typically, such a scan would have been used to determine any existing or potential spinal cord problems and any soft-tissue problems in the area of the fracture.

Not having such information, Dr. Orphanos was unaware that his patient had “an abundance of epidural fat, cord compression, cord edema, spinal abnormality, and spinal cord injury,” the complaint states. The neurosurgeon’s operative plan, therefore, included neither decompression of the spinal column nor use of neurophysiologic intraoperative monitoring, which is used to gauge, in real time during procedures, both how fast and how strongly a patient’s nerves are carrying signals.

Late on June 6, Dr. Orphanos performed a surgery to fuse his patient’s vertebrae from the T2 to the T6 region. Following the procedure, however, Mr. Rodgers experienced a complete loss of motor function and sensation in his lower extremities. A postoperative MRI proved inconclusive because of certain distorting effects of hardware implanted during the original surgery. Had a CT myelogram been ordered, it would have yielded a more accurate picture, the plaintiff alleged in his complaint.

Mr. Rodgers underwent a second surgery, during which Dr. Orphanos performed a T5 laminectomy. The patient’s loss of motor function and sensation persisted, however. He has been experiencing T5-level paraplegia ever since, with complete loss of control of his legs, bowel, and bladder.

In his complaint, Mr. Rodgers alleged that Dr. Orphanos had repeatedly deviated from the standard of care. Among other things, the plaintiff claimed, Dr. Orphanos had failed in both of his surgeries to order the proper preop and postop testing, thereby jeopardizing the outcomes of each procedure. This gross negligence and recklessness, the plaintiff argued, led directly to his permanent and disabling injuries.

Late last month, a West Virginia jury agreed that Dr. Orphanos was at fault and awarded Mr. Rodgers $17 million in damages.

Commented one of the pair of attorneys representing Mr. Rodgers: “We are very grateful to the jury, who saw through the attempts to rationalize the defendant’s conduct and delivered a jury verdict that will take care of Mr. Rodgers and provide the services he will need.”
 

Provider-to-provider disputes not time sensitive, state high court says

Early last month, Indiana’s high court ruled that the state’s med-mal statute of limitations doesn’t apply to disputes between providers, as a story in Radiology Business and other news sites reports.

The legal wrangling dates to April 2011. At that time, Joseph Shaughnessy underwent two CT scans at a Franciscan Alliance hospital, part of a healthcare system run by Franciscan Health. Outside radiologists from Lake Imaging read the scans, but they allegedly failed to note bleeding on the right side of the patient’s brain. Mr. Shaughnessy subsequently died, and his family filed suit against Franciscan, on the assumption that the radiologists were employees.

In 2015, the plaintiffs and Franciscan reached a $187,000 settlement, but Franciscan claimed it wasn’t liable for the payment, citing a clause in its prior agreement with Lake Imaging that protected it. But Lake Imaging sought to dismiss the Franciscan claim, arguing that the hospital system had failed to bring its suit within the state’s 2-year med-mal statute of limitations.

In its review of the case, the Indiana Supreme Court dismissed this argument: “(T)here is nothing in the [Medical Malpractice Act] to suggest that it extends beyond the physician-patient relationship to encompass commercial contracts between healthcare providers.”

In other words, while Indiana law places a 2-year limit on patients suing a hospital, doctor, or other healthcare professional, it places no such limit on contractually bound providers who take steps to sue each other.

As part of its unanimous decision, the high court also sent a claim by Lake Imaging against its insurance provider back to the trial court. The claim asks the insurance carrier — and not Lake Imaging — to assume responsibility for the settlement between Mr. Shaughnessy and Franciscan Alliance.

There was no word at press time as to when further legal proceedings would take place.
 

Paralyzed patient seeks millions

An Oregon man who was left paralyzed after undergoing surgery to address issues in his leg and foot has filed a large claim against both the hospital and surgical group involved in the procedure, details a story first reported by the Associated Press and picked up by other news outlets, including Fox12 Oregon.

On January 8, 2020, the man underwent brain surgery to address numbness in his left foot and a “vague” pain in his left leg. During the procedure, he experienced a dural tear, which the lead surgeon and his team addressed.

The following day, the man’s condition deteriorated, and he complained of severe pain, according to his lawsuit. Two days after his initial procedure, another surgeon performed a second procedure “to drain fluid and relieve pressure” on the patient’s brain. Nevertheless, the patient neither recovered sensation in his lower extremities nor use of his legs.

His claim against the facility and surgical practice asks for $43.5 million in damages for his injuries. For its part, the hospital expressed “deep compassion” for the patient and his family while making it clear that it believes its “caregivers provided excellent care.”

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

A jury last month found in favor of a West Virginia man who was permanently paralyzed following spinal cord surgery, according to a report by WOWK13 News, a local CBS affiliate in Huntington and Charleston, W. Va., among other news outlets.

On or about June 4, 2017, Michael Rodgers sustained injuries while riding his motorcycle. Admitted to Charleston Area Medical Center’s (CAMC’s) Level I trauma center, he initially showed no neurologic impairment and was able to feel and move all his extremities. A subsequent CT scan revealed, though, that he had incurred a T5 Chance fracture, as his later complaint states.

On June 6, a neurosurgeon affiliated with CAMC, John Orphanos, MD, instructed Mr. Rodgers to wear a back brace for 6 to 8 weeks. Later that day, though, Dr. Orphanos changed his course of treatment and recommended that Mr. Rodgers undergo surgery to treat his injuries. Despite his new recommendation, the neurosurgeon/spine specialist didn’t order a presurgical MRI of his patient’s thoracic spine. Typically, such a scan would have been used to determine any existing or potential spinal cord problems and any soft-tissue problems in the area of the fracture.

Not having such information, Dr. Orphanos was unaware that his patient had “an abundance of epidural fat, cord compression, cord edema, spinal abnormality, and spinal cord injury,” the complaint states. The neurosurgeon’s operative plan, therefore, included neither decompression of the spinal column nor use of neurophysiologic intraoperative monitoring, which is used to gauge, in real time during procedures, both how fast and how strongly a patient’s nerves are carrying signals.

Late on June 6, Dr. Orphanos performed a surgery to fuse his patient’s vertebrae from the T2 to the T6 region. Following the procedure, however, Mr. Rodgers experienced a complete loss of motor function and sensation in his lower extremities. A postoperative MRI proved inconclusive because of certain distorting effects of hardware implanted during the original surgery. Had a CT myelogram been ordered, it would have yielded a more accurate picture, the plaintiff alleged in his complaint.

Mr. Rodgers underwent a second surgery, during which Dr. Orphanos performed a T5 laminectomy. The patient’s loss of motor function and sensation persisted, however. He has been experiencing T5-level paraplegia ever since, with complete loss of control of his legs, bowel, and bladder.

In his complaint, Mr. Rodgers alleged that Dr. Orphanos had repeatedly deviated from the standard of care. Among other things, the plaintiff claimed, Dr. Orphanos had failed in both of his surgeries to order the proper preop and postop testing, thereby jeopardizing the outcomes of each procedure. This gross negligence and recklessness, the plaintiff argued, led directly to his permanent and disabling injuries.

Late last month, a West Virginia jury agreed that Dr. Orphanos was at fault and awarded Mr. Rodgers $17 million in damages.

Commented one of the pair of attorneys representing Mr. Rodgers: “We are very grateful to the jury, who saw through the attempts to rationalize the defendant’s conduct and delivered a jury verdict that will take care of Mr. Rodgers and provide the services he will need.”
 

Provider-to-provider disputes not time sensitive, state high court says

Early last month, Indiana’s high court ruled that the state’s med-mal statute of limitations doesn’t apply to disputes between providers, as a story in Radiology Business and other news sites reports.

The legal wrangling dates to April 2011. At that time, Joseph Shaughnessy underwent two CT scans at a Franciscan Alliance hospital, part of a healthcare system run by Franciscan Health. Outside radiologists from Lake Imaging read the scans, but they allegedly failed to note bleeding on the right side of the patient’s brain. Mr. Shaughnessy subsequently died, and his family filed suit against Franciscan, on the assumption that the radiologists were employees.

In 2015, the plaintiffs and Franciscan reached a $187,000 settlement, but Franciscan claimed it wasn’t liable for the payment, citing a clause in its prior agreement with Lake Imaging that protected it. But Lake Imaging sought to dismiss the Franciscan claim, arguing that the hospital system had failed to bring its suit within the state’s 2-year med-mal statute of limitations.

In its review of the case, the Indiana Supreme Court dismissed this argument: “(T)here is nothing in the [Medical Malpractice Act] to suggest that it extends beyond the physician-patient relationship to encompass commercial contracts between healthcare providers.”

In other words, while Indiana law places a 2-year limit on patients suing a hospital, doctor, or other healthcare professional, it places no such limit on contractually bound providers who take steps to sue each other.

As part of its unanimous decision, the high court also sent a claim by Lake Imaging against its insurance provider back to the trial court. The claim asks the insurance carrier — and not Lake Imaging — to assume responsibility for the settlement between Mr. Shaughnessy and Franciscan Alliance.

There was no word at press time as to when further legal proceedings would take place.
 

Paralyzed patient seeks millions

An Oregon man who was left paralyzed after undergoing surgery to address issues in his leg and foot has filed a large claim against both the hospital and surgical group involved in the procedure, details a story first reported by the Associated Press and picked up by other news outlets, including Fox12 Oregon.

On January 8, 2020, the man underwent brain surgery to address numbness in his left foot and a “vague” pain in his left leg. During the procedure, he experienced a dural tear, which the lead surgeon and his team addressed.

The following day, the man’s condition deteriorated, and he complained of severe pain, according to his lawsuit. Two days after his initial procedure, another surgeon performed a second procedure “to drain fluid and relieve pressure” on the patient’s brain. Nevertheless, the patient neither recovered sensation in his lower extremities nor use of his legs.

His claim against the facility and surgical practice asks for $43.5 million in damages for his injuries. For its part, the hospital expressed “deep compassion” for the patient and his family while making it clear that it believes its “caregivers provided excellent care.”

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

New research suggests that the casirivimab-imdevimab monoclonal antibody treatment for COVID-19 could have been delivered via injection instead of intravenously. There was no statistically significant difference in 28-day hospitalization or death in those treated intravenously and via subcutaneous injection.

The findings, published in JAMA Network Open, aren’t directly relevant at the moment, since the casirivimab-imdevimab treatment was abandoned when it failed to work during the Omicron outbreak. However, they point toward the importance of studying multiple routes of administration, said study lead author and pharmacist Erin K. McCreary, PharmD, of the University of Pittsburgh, in an interview.

“It would be beneficial for all future monoclonal antibodies for COVID-19 to be studied subcutaneously or intramuscularly, if possible, since that’s logistically easier than IV in the outpatient setting,” she said.

According to Dr. McCreary, an outpatient casirivimab-imdevimab treatment was used from 2020 to 2022 to treat higher-risk patients with mild to moderate COVID-19. The treatment was typically given intravenously as recommended by the federal government’s Emergency Use Authorization, she said. Clinical trials of the treatment, according to the study, allowed only IV administration.

“However, during the Delta surge, we were faced with so many patient referrals for treatment and staffing shortages that we couldn’t accommodate every patient unless we switched to [the] subcutaneous route,” Dr. McCreary said. This approach shortened appointment times by 30 minutes vs. infusion, she said.

There are many benefits to subcutaneous administration versus IV, Dr. McCreary said. “You don’t need to start an intravenous line, so you avoid the line kit and the nursing time needed for that. You draw up the drug directly into syringes and inject under the skin, so you avoid the need for a fluid bag to mix the drug in and run intravenously,” she said. “The appointment times are shorter, so you can accommodate more patients per day. Pharmacy interns can give subcutaneous injections, so you avoid the need for a nurse trained in placing intravenous lines.”

The researchers prospectively assigned 1,959 matched adults with mild to moderate COVID-19 to subcutaneous or intravenous treatment. Of 969 patients who received the subcutaneous treatment (mean age, 53.8; 56.4% women), the 28-day rate of hospitalization or death was 3.4%. Of 1,216 patients who received intravenous treatment (mean age, 54.3; 54.4% women), the rate was 1.7%. The difference was not statistically significant (P = .16).

Among 1,306 nontreated controls, 7.0% were hospitalized or died within 28 days (risk ratio = 0.48 vs. subcutaneous treatment group; 95% confidence interval, 0.30-0.80; P = .002).

“We did not find any patients where IV is a must,” Dr. McCreary said. “However, our study wasn’t powered to see a difference in certain subgroups.”

In an interview, University of Toronto internal medicine and pharmacology/toxicology physician Peter Wu, MD, said he agrees that the study has value because it emphasizes the importance of testing whether monoclonal antibodies can be administered in ways other than intravenously.

However, in the larger picture, he said, this may be irrelevant since it’s clear that anti-spike treatments are not holding up against COVID-19 variants.

No study funding is reported. Some study authors reported disclosures outside the submitted work. Dr. Wu has disclosed no relevant financial relationships.

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

New research suggests that the casirivimab-imdevimab monoclonal antibody treatment for COVID-19 could have been delivered via injection instead of intravenously. There was no statistically significant difference in 28-day hospitalization or death in those treated intravenously and via subcutaneous injection.

The findings, published in JAMA Network Open, aren’t directly relevant at the moment, since the casirivimab-imdevimab treatment was abandoned when it failed to work during the Omicron outbreak. However, they point toward the importance of studying multiple routes of administration, said study lead author and pharmacist Erin K. McCreary, PharmD, of the University of Pittsburgh, in an interview.

“It would be beneficial for all future monoclonal antibodies for COVID-19 to be studied subcutaneously or intramuscularly, if possible, since that’s logistically easier than IV in the outpatient setting,” she said.

According to Dr. McCreary, an outpatient casirivimab-imdevimab treatment was used from 2020 to 2022 to treat higher-risk patients with mild to moderate COVID-19. The treatment was typically given intravenously as recommended by the federal government’s Emergency Use Authorization, she said. Clinical trials of the treatment, according to the study, allowed only IV administration.

“However, during the Delta surge, we were faced with so many patient referrals for treatment and staffing shortages that we couldn’t accommodate every patient unless we switched to [the] subcutaneous route,” Dr. McCreary said. This approach shortened appointment times by 30 minutes vs. infusion, she said.

There are many benefits to subcutaneous administration versus IV, Dr. McCreary said. “You don’t need to start an intravenous line, so you avoid the line kit and the nursing time needed for that. You draw up the drug directly into syringes and inject under the skin, so you avoid the need for a fluid bag to mix the drug in and run intravenously,” she said. “The appointment times are shorter, so you can accommodate more patients per day. Pharmacy interns can give subcutaneous injections, so you avoid the need for a nurse trained in placing intravenous lines.”

The researchers prospectively assigned 1,959 matched adults with mild to moderate COVID-19 to subcutaneous or intravenous treatment. Of 969 patients who received the subcutaneous treatment (mean age, 53.8; 56.4% women), the 28-day rate of hospitalization or death was 3.4%. Of 1,216 patients who received intravenous treatment (mean age, 54.3; 54.4% women), the rate was 1.7%. The difference was not statistically significant (P = .16).

Among 1,306 nontreated controls, 7.0% were hospitalized or died within 28 days (risk ratio = 0.48 vs. subcutaneous treatment group; 95% confidence interval, 0.30-0.80; P = .002).

“We did not find any patients where IV is a must,” Dr. McCreary said. “However, our study wasn’t powered to see a difference in certain subgroups.”

In an interview, University of Toronto internal medicine and pharmacology/toxicology physician Peter Wu, MD, said he agrees that the study has value because it emphasizes the importance of testing whether monoclonal antibodies can be administered in ways other than intravenously.

However, in the larger picture, he said, this may be irrelevant since it’s clear that anti-spike treatments are not holding up against COVID-19 variants.

No study funding is reported. Some study authors reported disclosures outside the submitted work. Dr. Wu has disclosed no relevant financial relationships.

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

New research suggests that the casirivimab-imdevimab monoclonal antibody treatment for COVID-19 could have been delivered via injection instead of intravenously. There was no statistically significant difference in 28-day hospitalization or death in those treated intravenously and via subcutaneous injection.

The findings, published in JAMA Network Open, aren’t directly relevant at the moment, since the casirivimab-imdevimab treatment was abandoned when it failed to work during the Omicron outbreak. However, they point toward the importance of studying multiple routes of administration, said study lead author and pharmacist Erin K. McCreary, PharmD, of the University of Pittsburgh, in an interview.

“It would be beneficial for all future monoclonal antibodies for COVID-19 to be studied subcutaneously or intramuscularly, if possible, since that’s logistically easier than IV in the outpatient setting,” she said.

According to Dr. McCreary, an outpatient casirivimab-imdevimab treatment was used from 2020 to 2022 to treat higher-risk patients with mild to moderate COVID-19. The treatment was typically given intravenously as recommended by the federal government’s Emergency Use Authorization, she said. Clinical trials of the treatment, according to the study, allowed only IV administration.

“However, during the Delta surge, we were faced with so many patient referrals for treatment and staffing shortages that we couldn’t accommodate every patient unless we switched to [the] subcutaneous route,” Dr. McCreary said. This approach shortened appointment times by 30 minutes vs. infusion, she said.

There are many benefits to subcutaneous administration versus IV, Dr. McCreary said. “You don’t need to start an intravenous line, so you avoid the line kit and the nursing time needed for that. You draw up the drug directly into syringes and inject under the skin, so you avoid the need for a fluid bag to mix the drug in and run intravenously,” she said. “The appointment times are shorter, so you can accommodate more patients per day. Pharmacy interns can give subcutaneous injections, so you avoid the need for a nurse trained in placing intravenous lines.”

The researchers prospectively assigned 1,959 matched adults with mild to moderate COVID-19 to subcutaneous or intravenous treatment. Of 969 patients who received the subcutaneous treatment (mean age, 53.8; 56.4% women), the 28-day rate of hospitalization or death was 3.4%. Of 1,216 patients who received intravenous treatment (mean age, 54.3; 54.4% women), the rate was 1.7%. The difference was not statistically significant (P = .16).

Among 1,306 nontreated controls, 7.0% were hospitalized or died within 28 days (risk ratio = 0.48 vs. subcutaneous treatment group; 95% confidence interval, 0.30-0.80; P = .002).

“We did not find any patients where IV is a must,” Dr. McCreary said. “However, our study wasn’t powered to see a difference in certain subgroups.”

In an interview, University of Toronto internal medicine and pharmacology/toxicology physician Peter Wu, MD, said he agrees that the study has value because it emphasizes the importance of testing whether monoclonal antibodies can be administered in ways other than intravenously.

However, in the larger picture, he said, this may be irrelevant since it’s clear that anti-spike treatments are not holding up against COVID-19 variants.

No study funding is reported. Some study authors reported disclosures outside the submitted work. Dr. Wu has disclosed no relevant financial relationships.

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