Pulmonary Health Hub

Wearing a mask at home, even when everyone is feeling fine, might reduce the risk of frontline healthcare workers transmitting SARS-CoV-2 infection to their families, a recent study from China suggests. But the benefits might not outweigh the costs, according to several physicians interviewed.

“My gut reaction is that home mask use for healthcare workers would place an inordinately high burden on those healthcare workers and their families,” said Jeanne Noble, MD, an emergency care physician at the University of California, San Francisco. “Wearing a mask for a 10-hour shift already represents significant physical discomfort, causing sores across the nose and behind the ears. The emotional toll of the physical distance that comes with mask use, with limited facial expression, is also quite real.”

The suggested benefit of home mask use comes from research published online May 28 in BMJ Global Health. To assess predictors of household transmission of SARS-CoV-2 infection, Yu Wang, MD, of the Beijing Center for Disease Prevention and Control and colleagues conducted a retrospective study of 124 families in Beijing in which there was a confirmed case of COVID-19 as of February 21. The researchers surveyed family members by telephone about household hygiene and behaviors during the pandemic to examine risk factors for transmission.

During the 2 weeks following onset of the primary case, secondary transmission occurred in 41 families. Overall, 77 of 335 family members developed COVID-19.

A multivariable logistic regression analysis found that in households in which family members wore masks at home before the first person became ill, there was less likelihood of transmission of disease to a family member, compared with families in which no one wore a mask prior to illness onset.

“Facemasks were 79% effective and disinfection was 77% effective in preventing transmission,” the researchers report, “whilst close frequent contact in the household increased the risk of transmission 18 times, and diarrhea in the index patient increased the risk by four times.

However, wearing masks after symptom onset was not protective, according to the analysis. The findings support “universal face mask use, and also provides guidance on risk reduction for families living with someone in quarantine or isolation, and families of health workers, who may face ongoing risk,” the authors write.

Still, other precautions may be more important, experts say.

“I think by far the best way for healthcare professionals to protect their families is to carefully employ appropriate infection prevention measures at work,” said Mark E. Rupp, MD, chief of the Division of Infectious Diseases at Nebraska Medical Center in Omaha. “The combination of administrative interventions, engineering improvements, and personal protective equipment is very effective in preventing SARS-CoV-2 acquisition in the workplace.”

Many physicians already wear masks at home, and this study “only reemphasized the importance of doing so,” said Raghavendra Tirupathi, MD, medical director of Keystone Infectious Diseases in Chambersburg, Pennsylvania, who recently reviewed studies about masks and COVID-19.

Home mask use provides “one more layer of protection that might help mitigate the risk of transmission to family members,” Tirupathi said. But it does not obviate the need to follow other preventive measures, such as social distancing and proper hygiene.

But Rupp, whose advice on how healthcare workers can protect their families was recently highlighted by the American Medical Association, isn’t convinced. He said he won’t be adding home mask use to his list of recommendations. “It would be intrusive, cumbersome, and impractical to wear a mask in the home setting,” Rupp said in an interview.

However, when out in the community, all family members must protect one another by practicing social distancing, wearing masks, and practicing proper hand hygiene. “I also think that it is a good idea to have some masks on hand in case anyone does develop symptoms in the household and to wear them if a family member falls ill ― at least until testing can confirm COVID-19,” Rupp said. “If a family member does fall ill, masks for the ill person as well as the well persons would be indicated along with other home quarantine measures.”

For her part, Noble, who has provided guidance about proper mask use, said that targeted use of masks at home, such as around older visiting relatives or other more vulnerable family members, may be more realistic than continuous in-home use.

When a household member becomes ill, recommendations for preventing disease spread include having a sick family member sleep in a separate bedroom, using a separate bathroom, and wearing a mask when within 6 feet of other household members. They also should avoid sharing meals. “For a household member who is a medical provider, to follow these self-isolation precautions while at home for months on end would have a significant emotional toll,” Noble said in an email. “With no end in sight for the pandemic, perpetual mask use in both the private and public sphere strikes me as overwhelming ― I write this near the end of my 10-hour shift wearing both an N95 and surgical mask and counting the minutes before I can take them off!”

A limitation of the study was its reliance on telephone interviews, which are subject to recall bias, the authors note.

The study was funded by the Beijing Science and Technology Planning Project. The researchers have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Wearing a mask at home, even when everyone is feeling fine, might reduce the risk of frontline healthcare workers transmitting SARS-CoV-2 infection to their families, a recent study from China suggests. But the benefits might not outweigh the costs, according to several physicians interviewed.

“My gut reaction is that home mask use for healthcare workers would place an inordinately high burden on those healthcare workers and their families,” said Jeanne Noble, MD, an emergency care physician at the University of California, San Francisco. “Wearing a mask for a 10-hour shift already represents significant physical discomfort, causing sores across the nose and behind the ears. The emotional toll of the physical distance that comes with mask use, with limited facial expression, is also quite real.”

The suggested benefit of home mask use comes from research published online May 28 in BMJ Global Health. To assess predictors of household transmission of SARS-CoV-2 infection, Yu Wang, MD, of the Beijing Center for Disease Prevention and Control and colleagues conducted a retrospective study of 124 families in Beijing in which there was a confirmed case of COVID-19 as of February 21. The researchers surveyed family members by telephone about household hygiene and behaviors during the pandemic to examine risk factors for transmission.

During the 2 weeks following onset of the primary case, secondary transmission occurred in 41 families. Overall, 77 of 335 family members developed COVID-19.

A multivariable logistic regression analysis found that in households in which family members wore masks at home before the first person became ill, there was less likelihood of transmission of disease to a family member, compared with families in which no one wore a mask prior to illness onset.

“Facemasks were 79% effective and disinfection was 77% effective in preventing transmission,” the researchers report, “whilst close frequent contact in the household increased the risk of transmission 18 times, and diarrhea in the index patient increased the risk by four times.

However, wearing masks after symptom onset was not protective, according to the analysis. The findings support “universal face mask use, and also provides guidance on risk reduction for families living with someone in quarantine or isolation, and families of health workers, who may face ongoing risk,” the authors write.

Still, other precautions may be more important, experts say.

“I think by far the best way for healthcare professionals to protect their families is to carefully employ appropriate infection prevention measures at work,” said Mark E. Rupp, MD, chief of the Division of Infectious Diseases at Nebraska Medical Center in Omaha. “The combination of administrative interventions, engineering improvements, and personal protective equipment is very effective in preventing SARS-CoV-2 acquisition in the workplace.”

Many physicians already wear masks at home, and this study “only reemphasized the importance of doing so,” said Raghavendra Tirupathi, MD, medical director of Keystone Infectious Diseases in Chambersburg, Pennsylvania, who recently reviewed studies about masks and COVID-19.

Home mask use provides “one more layer of protection that might help mitigate the risk of transmission to family members,” Tirupathi said. But it does not obviate the need to follow other preventive measures, such as social distancing and proper hygiene.

But Rupp, whose advice on how healthcare workers can protect their families was recently highlighted by the American Medical Association, isn’t convinced. He said he won’t be adding home mask use to his list of recommendations. “It would be intrusive, cumbersome, and impractical to wear a mask in the home setting,” Rupp said in an interview.

However, when out in the community, all family members must protect one another by practicing social distancing, wearing masks, and practicing proper hand hygiene. “I also think that it is a good idea to have some masks on hand in case anyone does develop symptoms in the household and to wear them if a family member falls ill ― at least until testing can confirm COVID-19,” Rupp said. “If a family member does fall ill, masks for the ill person as well as the well persons would be indicated along with other home quarantine measures.”

For her part, Noble, who has provided guidance about proper mask use, said that targeted use of masks at home, such as around older visiting relatives or other more vulnerable family members, may be more realistic than continuous in-home use.

When a household member becomes ill, recommendations for preventing disease spread include having a sick family member sleep in a separate bedroom, using a separate bathroom, and wearing a mask when within 6 feet of other household members. They also should avoid sharing meals. “For a household member who is a medical provider, to follow these self-isolation precautions while at home for months on end would have a significant emotional toll,” Noble said in an email. “With no end in sight for the pandemic, perpetual mask use in both the private and public sphere strikes me as overwhelming ― I write this near the end of my 10-hour shift wearing both an N95 and surgical mask and counting the minutes before I can take them off!”

A limitation of the study was its reliance on telephone interviews, which are subject to recall bias, the authors note.

The study was funded by the Beijing Science and Technology Planning Project. The researchers have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Wearing a mask at home, even when everyone is feeling fine, might reduce the risk of frontline healthcare workers transmitting SARS-CoV-2 infection to their families, a recent study from China suggests. But the benefits might not outweigh the costs, according to several physicians interviewed.

“My gut reaction is that home mask use for healthcare workers would place an inordinately high burden on those healthcare workers and their families,” said Jeanne Noble, MD, an emergency care physician at the University of California, San Francisco. “Wearing a mask for a 10-hour shift already represents significant physical discomfort, causing sores across the nose and behind the ears. The emotional toll of the physical distance that comes with mask use, with limited facial expression, is also quite real.”

The suggested benefit of home mask use comes from research published online May 28 in BMJ Global Health. To assess predictors of household transmission of SARS-CoV-2 infection, Yu Wang, MD, of the Beijing Center for Disease Prevention and Control and colleagues conducted a retrospective study of 124 families in Beijing in which there was a confirmed case of COVID-19 as of February 21. The researchers surveyed family members by telephone about household hygiene and behaviors during the pandemic to examine risk factors for transmission.

During the 2 weeks following onset of the primary case, secondary transmission occurred in 41 families. Overall, 77 of 335 family members developed COVID-19.

A multivariable logistic regression analysis found that in households in which family members wore masks at home before the first person became ill, there was less likelihood of transmission of disease to a family member, compared with families in which no one wore a mask prior to illness onset.

“Facemasks were 79% effective and disinfection was 77% effective in preventing transmission,” the researchers report, “whilst close frequent contact in the household increased the risk of transmission 18 times, and diarrhea in the index patient increased the risk by four times.

However, wearing masks after symptom onset was not protective, according to the analysis. The findings support “universal face mask use, and also provides guidance on risk reduction for families living with someone in quarantine or isolation, and families of health workers, who may face ongoing risk,” the authors write.

Still, other precautions may be more important, experts say.

“I think by far the best way for healthcare professionals to protect their families is to carefully employ appropriate infection prevention measures at work,” said Mark E. Rupp, MD, chief of the Division of Infectious Diseases at Nebraska Medical Center in Omaha. “The combination of administrative interventions, engineering improvements, and personal protective equipment is very effective in preventing SARS-CoV-2 acquisition in the workplace.”

Many physicians already wear masks at home, and this study “only reemphasized the importance of doing so,” said Raghavendra Tirupathi, MD, medical director of Keystone Infectious Diseases in Chambersburg, Pennsylvania, who recently reviewed studies about masks and COVID-19.

Home mask use provides “one more layer of protection that might help mitigate the risk of transmission to family members,” Tirupathi said. But it does not obviate the need to follow other preventive measures, such as social distancing and proper hygiene.

But Rupp, whose advice on how healthcare workers can protect their families was recently highlighted by the American Medical Association, isn’t convinced. He said he won’t be adding home mask use to his list of recommendations. “It would be intrusive, cumbersome, and impractical to wear a mask in the home setting,” Rupp said in an interview.

However, when out in the community, all family members must protect one another by practicing social distancing, wearing masks, and practicing proper hand hygiene. “I also think that it is a good idea to have some masks on hand in case anyone does develop symptoms in the household and to wear them if a family member falls ill ― at least until testing can confirm COVID-19,” Rupp said. “If a family member does fall ill, masks for the ill person as well as the well persons would be indicated along with other home quarantine measures.”

For her part, Noble, who has provided guidance about proper mask use, said that targeted use of masks at home, such as around older visiting relatives or other more vulnerable family members, may be more realistic than continuous in-home use.

When a household member becomes ill, recommendations for preventing disease spread include having a sick family member sleep in a separate bedroom, using a separate bathroom, and wearing a mask when within 6 feet of other household members. They also should avoid sharing meals. “For a household member who is a medical provider, to follow these self-isolation precautions while at home for months on end would have a significant emotional toll,” Noble said in an email. “With no end in sight for the pandemic, perpetual mask use in both the private and public sphere strikes me as overwhelming ― I write this near the end of my 10-hour shift wearing both an N95 and surgical mask and counting the minutes before I can take them off!”

A limitation of the study was its reliance on telephone interviews, which are subject to recall bias, the authors note.

The study was funded by the Beijing Science and Technology Planning Project. The researchers have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Exposure to maternal antenatal corticosteroid treatment is significantly associated with mental and behavioral disorders in children, compared with nonexposure, according to a Finnish population-based study published in JAMA. The findings may lead to changes in clinical practice, particularly for infants who may be born full term.

After adjustment for variables such as maternal age, smoking during pregnancy, any lifetime mental disorder diagnosis, and gestational age at birth, exposure to maternal antenatal corticosteroid treatment was significantly associated with mental and behavioral disorders in children, compared with nonexposure, with a hazard ratio of 1.33. Among children born at term, the adjusted hazard ratio was 1.47. Among preterm children, the hazard ratio was not significant.

“Although benefits of this therapy outweigh risks in the most vulnerable infants, this may not be true for all infants,” wrote Sara B. DeMauro, MD, an attending neonatologist and program director of the neonatal follow-up program at Children’s Hospital of Philadelphia, in an editorial also published in JAMA. “Recommendations to administer this therapy to broader populations of pregnant women may need to be reexamined until sufficient safety data, particularly among more mature infants, are available.”

Corticosteroid treatment to accelerate fetal maturation is standard care before 34 weeks’ gestation when there is a likelihood of delivery within 7 days, and studies have found that providing this therapy reduces the risk for respiratory problems when administered beyond 34 weeks. In 2016, updates to U.S. guidelines allowed for the use of corticosteroid treatment between 34 weeks and 36 weeks 6 days when women are at risk for preterm delivery within 7 days and have not received a previous course of antenatal corticosteroids.

The data from Finland indicate that “a significant number of very preterm children who might have benefited from this treatment did not receive it,” Dr. DeMauro wrote. At the same time, “45% of steroid-exposed infants were delivered at term. In these infants, minor short-term benefit may have been outweighed by significant longer-term risks. These data elucidate both the continuing struggle to accurately predict preterm birth and the incomplete uptake of an effective therapy that is beneficial when administered to the correct patients.”
 

Pause expanded use?

“Since the recommendations came out to expand the use of corticosteroids for preterm labor up until 37 weeks gestational age, my practice has incorporated these guidelines,” said Santina Wheat, MD, assistant professor of family and community medicine at Northwestern University in Chicago. “We have incorporated the guidelines though with the understanding that the benefits outweigh the risk. This article indicates that we may have been wrong in that understanding.” Although the association does not establish that the treatment causes mental and behavioral disorders, it “raises the question of whether we should halt this practice until additional information can be gathered,” noted Dr. Wheat, who also serves on the editorial advisory board of Family Practice News.

When administered before delivery of a very premature infant, corticosteroid therapy accelerates fetal lung maturation and helps prevent neonatal mortality, respiratory distress syndrome, and brain injury. Investigators demonstrated the benefits of antenatal corticosteroids in 1972, and the treatment – “one of the most important advances in perinatal care” – became widely used in the 1990s, Dr. DeMauro said.

To examine whether treatment exposure is associated with a risk of childhood mental and behavioral disorders and whether the risk is similar in infants born at term and preterm, Katri Räikkönen, PhD, a researcher at the University of Helsinki, and colleagues conducted a population-based retrospective study of more than 670,000 children.

The researchers identified all singleton pregnancies ending in a live birth in Finland during Jan. 1, 2006–Dec.31, 2017. In addition, they identified all consecutive maternal sibling pairs born at term, including sibling pairs discordant for maternal antenatal corticosteroid treatment exposure and sibling pairs concordant for treatment exposure or nonexposure. The investigators identified diagnoses of childhood mental and behavioral disorders using the Finnish Care Register for Health Care using ICD-10 codes on hospital inpatient and outpatient treatments by physicians in specialized medical care.
 

A range of disorders

In all, 670,097 infants with a median follow-up duration of 5.8 years were included in the analysis, and 14,868 (2.22%) were exposed to antenatal corticosteroids. Of the treatment-exposed children, about 45% were born at term. Of the nonexposed children, approximately 97% were born at term. Cumulative incidence rates for any mental and behavioral disorder were significantly higher for treatment-exposed children, compared with nonexposed children, in the entire cohort (12.01% vs. 6.45%; P less than .001) and in term-born children (8.89% vs. 6.31%; P less than .001).

In preterm children, the incidence rate of any mental and behavioral disorder was significantly higher among those with treatment exposure (14.59% vs. 10.71%; P less than .001). Associations persisted when the investigators focused on 241,621 sibling pairs, “suggesting that unmeasured familial confounding did not explain these associations,” the authors said.

“[In] the entire cohort and term-born children, treatment exposure ... was significantly associated with psychological development disorders; attention-deficit/hyperactivity or conduct disorders; mixed disorders of conduct and emotions, emotional disorders, disorders of social functioning or tic disorders; other behavioral or emotional disorders; and sleep disorders,” Dr. Räikkönen and colleagues reported. Among preterm-born, treatment-exposed children, the adjusted hazard ratio was significantly lower for intellectual disability and higher for sleep disorders.

Dr. DeMauro noted potential confounders in this observational study, including abnormal pregnancy events that lead clinicians to administer steroids. Such events “predispose the exposed children to adverse cognitive outcomes,” suggests some research. “Alternately, after a pregnancy at high risk for preterm delivery, families may perceive their children as vulnerable and therefore may be more likely to seek care and earlier diagnosis of mental or behavioral disorders,” Dr. DeMauro said.

The study was funded by the Academy of Finland, European Commission, Foundation for Pediatric Research, the Signe and Ane Gyllenberg Foundation, the Novo Nordisk Foundation, the Sigrid Juselius Foundation, and the Juho Vainio Foundation. The investigators and Dr. DeMauro had no conflict of interest disclosures.

[email protected]

SOURCE: Räikkönen K et al. JAMA. 2020;323(19):1924-33. doi: 10.1001/jama.2020.3937.

Exposure to maternal antenatal corticosteroid treatment is significantly associated with mental and behavioral disorders in children, compared with nonexposure, according to a Finnish population-based study published in JAMA. The findings may lead to changes in clinical practice, particularly for infants who may be born full term.

After adjustment for variables such as maternal age, smoking during pregnancy, any lifetime mental disorder diagnosis, and gestational age at birth, exposure to maternal antenatal corticosteroid treatment was significantly associated with mental and behavioral disorders in children, compared with nonexposure, with a hazard ratio of 1.33. Among children born at term, the adjusted hazard ratio was 1.47. Among preterm children, the hazard ratio was not significant.

“Although benefits of this therapy outweigh risks in the most vulnerable infants, this may not be true for all infants,” wrote Sara B. DeMauro, MD, an attending neonatologist and program director of the neonatal follow-up program at Children’s Hospital of Philadelphia, in an editorial also published in JAMA. “Recommendations to administer this therapy to broader populations of pregnant women may need to be reexamined until sufficient safety data, particularly among more mature infants, are available.”

Corticosteroid treatment to accelerate fetal maturation is standard care before 34 weeks’ gestation when there is a likelihood of delivery within 7 days, and studies have found that providing this therapy reduces the risk for respiratory problems when administered beyond 34 weeks. In 2016, updates to U.S. guidelines allowed for the use of corticosteroid treatment between 34 weeks and 36 weeks 6 days when women are at risk for preterm delivery within 7 days and have not received a previous course of antenatal corticosteroids.

The data from Finland indicate that “a significant number of very preterm children who might have benefited from this treatment did not receive it,” Dr. DeMauro wrote. At the same time, “45% of steroid-exposed infants were delivered at term. In these infants, minor short-term benefit may have been outweighed by significant longer-term risks. These data elucidate both the continuing struggle to accurately predict preterm birth and the incomplete uptake of an effective therapy that is beneficial when administered to the correct patients.”
 

Pause expanded use?

“Since the recommendations came out to expand the use of corticosteroids for preterm labor up until 37 weeks gestational age, my practice has incorporated these guidelines,” said Santina Wheat, MD, assistant professor of family and community medicine at Northwestern University in Chicago. “We have incorporated the guidelines though with the understanding that the benefits outweigh the risk. This article indicates that we may have been wrong in that understanding.” Although the association does not establish that the treatment causes mental and behavioral disorders, it “raises the question of whether we should halt this practice until additional information can be gathered,” noted Dr. Wheat, who also serves on the editorial advisory board of Family Practice News.

When administered before delivery of a very premature infant, corticosteroid therapy accelerates fetal lung maturation and helps prevent neonatal mortality, respiratory distress syndrome, and brain injury. Investigators demonstrated the benefits of antenatal corticosteroids in 1972, and the treatment – “one of the most important advances in perinatal care” – became widely used in the 1990s, Dr. DeMauro said.

To examine whether treatment exposure is associated with a risk of childhood mental and behavioral disorders and whether the risk is similar in infants born at term and preterm, Katri Räikkönen, PhD, a researcher at the University of Helsinki, and colleagues conducted a population-based retrospective study of more than 670,000 children.

The researchers identified all singleton pregnancies ending in a live birth in Finland during Jan. 1, 2006–Dec.31, 2017. In addition, they identified all consecutive maternal sibling pairs born at term, including sibling pairs discordant for maternal antenatal corticosteroid treatment exposure and sibling pairs concordant for treatment exposure or nonexposure. The investigators identified diagnoses of childhood mental and behavioral disorders using the Finnish Care Register for Health Care using ICD-10 codes on hospital inpatient and outpatient treatments by physicians in specialized medical care.
 

A range of disorders

In all, 670,097 infants with a median follow-up duration of 5.8 years were included in the analysis, and 14,868 (2.22%) were exposed to antenatal corticosteroids. Of the treatment-exposed children, about 45% were born at term. Of the nonexposed children, approximately 97% were born at term. Cumulative incidence rates for any mental and behavioral disorder were significantly higher for treatment-exposed children, compared with nonexposed children, in the entire cohort (12.01% vs. 6.45%; P less than .001) and in term-born children (8.89% vs. 6.31%; P less than .001).

In preterm children, the incidence rate of any mental and behavioral disorder was significantly higher among those with treatment exposure (14.59% vs. 10.71%; P less than .001). Associations persisted when the investigators focused on 241,621 sibling pairs, “suggesting that unmeasured familial confounding did not explain these associations,” the authors said.

“[In] the entire cohort and term-born children, treatment exposure ... was significantly associated with psychological development disorders; attention-deficit/hyperactivity or conduct disorders; mixed disorders of conduct and emotions, emotional disorders, disorders of social functioning or tic disorders; other behavioral or emotional disorders; and sleep disorders,” Dr. Räikkönen and colleagues reported. Among preterm-born, treatment-exposed children, the adjusted hazard ratio was significantly lower for intellectual disability and higher for sleep disorders.

Dr. DeMauro noted potential confounders in this observational study, including abnormal pregnancy events that lead clinicians to administer steroids. Such events “predispose the exposed children to adverse cognitive outcomes,” suggests some research. “Alternately, after a pregnancy at high risk for preterm delivery, families may perceive their children as vulnerable and therefore may be more likely to seek care and earlier diagnosis of mental or behavioral disorders,” Dr. DeMauro said.

The study was funded by the Academy of Finland, European Commission, Foundation for Pediatric Research, the Signe and Ane Gyllenberg Foundation, the Novo Nordisk Foundation, the Sigrid Juselius Foundation, and the Juho Vainio Foundation. The investigators and Dr. DeMauro had no conflict of interest disclosures.

[email protected]

SOURCE: Räikkönen K et al. JAMA. 2020;323(19):1924-33. doi: 10.1001/jama.2020.3937.

Exposure to maternal antenatal corticosteroid treatment is significantly associated with mental and behavioral disorders in children, compared with nonexposure, according to a Finnish population-based study published in JAMA. The findings may lead to changes in clinical practice, particularly for infants who may be born full term.

After adjustment for variables such as maternal age, smoking during pregnancy, any lifetime mental disorder diagnosis, and gestational age at birth, exposure to maternal antenatal corticosteroid treatment was significantly associated with mental and behavioral disorders in children, compared with nonexposure, with a hazard ratio of 1.33. Among children born at term, the adjusted hazard ratio was 1.47. Among preterm children, the hazard ratio was not significant.

“Although benefits of this therapy outweigh risks in the most vulnerable infants, this may not be true for all infants,” wrote Sara B. DeMauro, MD, an attending neonatologist and program director of the neonatal follow-up program at Children’s Hospital of Philadelphia, in an editorial also published in JAMA. “Recommendations to administer this therapy to broader populations of pregnant women may need to be reexamined until sufficient safety data, particularly among more mature infants, are available.”

Corticosteroid treatment to accelerate fetal maturation is standard care before 34 weeks’ gestation when there is a likelihood of delivery within 7 days, and studies have found that providing this therapy reduces the risk for respiratory problems when administered beyond 34 weeks. In 2016, updates to U.S. guidelines allowed for the use of corticosteroid treatment between 34 weeks and 36 weeks 6 days when women are at risk for preterm delivery within 7 days and have not received a previous course of antenatal corticosteroids.

The data from Finland indicate that “a significant number of very preterm children who might have benefited from this treatment did not receive it,” Dr. DeMauro wrote. At the same time, “45% of steroid-exposed infants were delivered at term. In these infants, minor short-term benefit may have been outweighed by significant longer-term risks. These data elucidate both the continuing struggle to accurately predict preterm birth and the incomplete uptake of an effective therapy that is beneficial when administered to the correct patients.”
 

Pause expanded use?

“Since the recommendations came out to expand the use of corticosteroids for preterm labor up until 37 weeks gestational age, my practice has incorporated these guidelines,” said Santina Wheat, MD, assistant professor of family and community medicine at Northwestern University in Chicago. “We have incorporated the guidelines though with the understanding that the benefits outweigh the risk. This article indicates that we may have been wrong in that understanding.” Although the association does not establish that the treatment causes mental and behavioral disorders, it “raises the question of whether we should halt this practice until additional information can be gathered,” noted Dr. Wheat, who also serves on the editorial advisory board of Family Practice News.

When administered before delivery of a very premature infant, corticosteroid therapy accelerates fetal lung maturation and helps prevent neonatal mortality, respiratory distress syndrome, and brain injury. Investigators demonstrated the benefits of antenatal corticosteroids in 1972, and the treatment – “one of the most important advances in perinatal care” – became widely used in the 1990s, Dr. DeMauro said.

To examine whether treatment exposure is associated with a risk of childhood mental and behavioral disorders and whether the risk is similar in infants born at term and preterm, Katri Räikkönen, PhD, a researcher at the University of Helsinki, and colleagues conducted a population-based retrospective study of more than 670,000 children.

The researchers identified all singleton pregnancies ending in a live birth in Finland during Jan. 1, 2006–Dec.31, 2017. In addition, they identified all consecutive maternal sibling pairs born at term, including sibling pairs discordant for maternal antenatal corticosteroid treatment exposure and sibling pairs concordant for treatment exposure or nonexposure. The investigators identified diagnoses of childhood mental and behavioral disorders using the Finnish Care Register for Health Care using ICD-10 codes on hospital inpatient and outpatient treatments by physicians in specialized medical care.
 

A range of disorders

In all, 670,097 infants with a median follow-up duration of 5.8 years were included in the analysis, and 14,868 (2.22%) were exposed to antenatal corticosteroids. Of the treatment-exposed children, about 45% were born at term. Of the nonexposed children, approximately 97% were born at term. Cumulative incidence rates for any mental and behavioral disorder were significantly higher for treatment-exposed children, compared with nonexposed children, in the entire cohort (12.01% vs. 6.45%; P less than .001) and in term-born children (8.89% vs. 6.31%; P less than .001).

In preterm children, the incidence rate of any mental and behavioral disorder was significantly higher among those with treatment exposure (14.59% vs. 10.71%; P less than .001). Associations persisted when the investigators focused on 241,621 sibling pairs, “suggesting that unmeasured familial confounding did not explain these associations,” the authors said.

“[In] the entire cohort and term-born children, treatment exposure ... was significantly associated with psychological development disorders; attention-deficit/hyperactivity or conduct disorders; mixed disorders of conduct and emotions, emotional disorders, disorders of social functioning or tic disorders; other behavioral or emotional disorders; and sleep disorders,” Dr. Räikkönen and colleagues reported. Among preterm-born, treatment-exposed children, the adjusted hazard ratio was significantly lower for intellectual disability and higher for sleep disorders.

Dr. DeMauro noted potential confounders in this observational study, including abnormal pregnancy events that lead clinicians to administer steroids. Such events “predispose the exposed children to adverse cognitive outcomes,” suggests some research. “Alternately, after a pregnancy at high risk for preterm delivery, families may perceive their children as vulnerable and therefore may be more likely to seek care and earlier diagnosis of mental or behavioral disorders,” Dr. DeMauro said.

The study was funded by the Academy of Finland, European Commission, Foundation for Pediatric Research, the Signe and Ane Gyllenberg Foundation, the Novo Nordisk Foundation, the Sigrid Juselius Foundation, and the Juho Vainio Foundation. The investigators and Dr. DeMauro had no conflict of interest disclosures.

[email protected]

SOURCE: Räikkönen K et al. JAMA. 2020;323(19):1924-33. doi: 10.1001/jama.2020.3937.

The vast majority of patients with rheumatic and musculoskeletal diseases who contract COVID-19 recover from the virus, regardless of which medication they receive for their rheumatic condition, new international research suggests.

“These results provide, for the first time, information about the outcome of COVID-19 in patients with rheumatic and musculoskeletal diseases,” said study investigator Pedro Machado, MD, PhD, from University College London. “They should provide some reassurance to patients and healthcare providers.”

Machado and his colleagues looked at 600 COVID-19 patients from 40 countries, and found that those taking TNF inhibitors for their rheumatic disease were less likely to be hospitalized for COVID-19. However, treatment with more than 10 mg of prednisone daily — considered a moderate to high dose — was associated with a higher probability of hospitalization.

In addition, hospitalization was not associated with biologics; JAK inhibitors; conventional disease-modifying antirheumatic drugs (DMARDs), such as methotrexate; antimalarials, such as hydroxychloroquine; or nonsteroidal anti-inflammatory drugs (NSAIDs) — either alone or in combination with other biologics, such as TNF-alpha inhibitors.

The findings were presented at the virtual European League Against Rheumatism (EULAR) 2020 Congress and were published online in Annals of the Rheumatic Diseases.

“Initially, there was a huge concern that these drugs could affect the outcome of patients getting COVID-19, but what this is showing is that probably these drugs do not increase their risk of severe outcome,” Machado, who is chair of the EULAR standing committee on epidemiology and health services research, told Medscape Medical News.

As of June 1, 1061 patients from 28 participating countries had been entered into the EULAR COVID-19 database, which was launched as part of the international Global Rheumatology Alliance registry. Patient data are categorized by factors such as top rheumatology diagnosis, comorbidities, top-five COVID-19 symptoms, and DMARD therapy at the time of virus infection. Anonymized data will be shared with an international register based in the United States.

Machado’s team combined data from the EULAR and Global Rheumatology Alliance COVID-19 registries from March 24 to April 20. They looked at patient factors — such as age, sex, smoking status, rheumatic diagnosis, comorbidities, and rheumatic therapies — to examine the association of rheumatic therapies with hospitalization rates and COVID-19 disease course.

Of the 277 patients (46%) in the study cohort who required hospitalization, 55 (9%) died. But this finding shouldn’t be viewed as the true rate of hospitalization or death in patients with rheumatic disease and COVID-19, said Gerd Burmester, MD, from Charité–University Medicine Berlin.

“There’s tremendous bias in terms of more serious cases of COVID-19 being reported to the registries,” he explained, “because the mild cases won’t even show up at their rheumatologist’s office.”

“This can skew the idea that COVID-19 is much more dangerous to rheumatic patients than to the regular population,” Burmester told Medscape Medical News. “It scares the patients, obviously, but we believe this is not justified.”

It’s still unclear whether rituximab use raises the risk for severe COVID-19, he said. “It appears to be the only biologic for which the jury is still out,” he said.

“Anti-TNFs and anti-IL-6 drugs may even be beneficial, although we don’t have robust data,” he added.

The study can only highlight associations between rheumatic drugs and COVID-19 outcomes. “We cannot say there is a causal relationship between the findings,” Machado said.

Longer-term data, when available, should illuminate “more granular” aspects of COVID-19 outcomes in rheumatic patients, including their risks of requiring ventilation or developing a cytokine storm, he noted.

Burmester and Machado agree that research needs to continue as the pandemic rages on. But so far, “there are no data suggesting that, if you’re on a targeted, dedicated immunomodulator, your risk is higher to have a worse course of COVID-19 than the general population,” Burmester said.

“We simply didn’t know that when the pandemic started, and some patients even discontinued their drugs out of this fear,” he added. “It’s more reassuring than we originally thought.”

This article first appeared on Medscape.com.

The vast majority of patients with rheumatic and musculoskeletal diseases who contract COVID-19 recover from the virus, regardless of which medication they receive for their rheumatic condition, new international research suggests.

“These results provide, for the first time, information about the outcome of COVID-19 in patients with rheumatic and musculoskeletal diseases,” said study investigator Pedro Machado, MD, PhD, from University College London. “They should provide some reassurance to patients and healthcare providers.”

Machado and his colleagues looked at 600 COVID-19 patients from 40 countries, and found that those taking TNF inhibitors for their rheumatic disease were less likely to be hospitalized for COVID-19. However, treatment with more than 10 mg of prednisone daily — considered a moderate to high dose — was associated with a higher probability of hospitalization.

In addition, hospitalization was not associated with biologics; JAK inhibitors; conventional disease-modifying antirheumatic drugs (DMARDs), such as methotrexate; antimalarials, such as hydroxychloroquine; or nonsteroidal anti-inflammatory drugs (NSAIDs) — either alone or in combination with other biologics, such as TNF-alpha inhibitors.

The findings were presented at the virtual European League Against Rheumatism (EULAR) 2020 Congress and were published online in Annals of the Rheumatic Diseases.

“Initially, there was a huge concern that these drugs could affect the outcome of patients getting COVID-19, but what this is showing is that probably these drugs do not increase their risk of severe outcome,” Machado, who is chair of the EULAR standing committee on epidemiology and health services research, told Medscape Medical News.

As of June 1, 1061 patients from 28 participating countries had been entered into the EULAR COVID-19 database, which was launched as part of the international Global Rheumatology Alliance registry. Patient data are categorized by factors such as top rheumatology diagnosis, comorbidities, top-five COVID-19 symptoms, and DMARD therapy at the time of virus infection. Anonymized data will be shared with an international register based in the United States.

Machado’s team combined data from the EULAR and Global Rheumatology Alliance COVID-19 registries from March 24 to April 20. They looked at patient factors — such as age, sex, smoking status, rheumatic diagnosis, comorbidities, and rheumatic therapies — to examine the association of rheumatic therapies with hospitalization rates and COVID-19 disease course.

Of the 277 patients (46%) in the study cohort who required hospitalization, 55 (9%) died. But this finding shouldn’t be viewed as the true rate of hospitalization or death in patients with rheumatic disease and COVID-19, said Gerd Burmester, MD, from Charité–University Medicine Berlin.

“There’s tremendous bias in terms of more serious cases of COVID-19 being reported to the registries,” he explained, “because the mild cases won’t even show up at their rheumatologist’s office.”

“This can skew the idea that COVID-19 is much more dangerous to rheumatic patients than to the regular population,” Burmester told Medscape Medical News. “It scares the patients, obviously, but we believe this is not justified.”

It’s still unclear whether rituximab use raises the risk for severe COVID-19, he said. “It appears to be the only biologic for which the jury is still out,” he said.

“Anti-TNFs and anti-IL-6 drugs may even be beneficial, although we don’t have robust data,” he added.

The study can only highlight associations between rheumatic drugs and COVID-19 outcomes. “We cannot say there is a causal relationship between the findings,” Machado said.

Longer-term data, when available, should illuminate “more granular” aspects of COVID-19 outcomes in rheumatic patients, including their risks of requiring ventilation or developing a cytokine storm, he noted.

Burmester and Machado agree that research needs to continue as the pandemic rages on. But so far, “there are no data suggesting that, if you’re on a targeted, dedicated immunomodulator, your risk is higher to have a worse course of COVID-19 than the general population,” Burmester said.

“We simply didn’t know that when the pandemic started, and some patients even discontinued their drugs out of this fear,” he added. “It’s more reassuring than we originally thought.”

This article first appeared on Medscape.com.

The vast majority of patients with rheumatic and musculoskeletal diseases who contract COVID-19 recover from the virus, regardless of which medication they receive for their rheumatic condition, new international research suggests.

“These results provide, for the first time, information about the outcome of COVID-19 in patients with rheumatic and musculoskeletal diseases,” said study investigator Pedro Machado, MD, PhD, from University College London. “They should provide some reassurance to patients and healthcare providers.”

Machado and his colleagues looked at 600 COVID-19 patients from 40 countries, and found that those taking TNF inhibitors for their rheumatic disease were less likely to be hospitalized for COVID-19. However, treatment with more than 10 mg of prednisone daily — considered a moderate to high dose — was associated with a higher probability of hospitalization.

In addition, hospitalization was not associated with biologics; JAK inhibitors; conventional disease-modifying antirheumatic drugs (DMARDs), such as methotrexate; antimalarials, such as hydroxychloroquine; or nonsteroidal anti-inflammatory drugs (NSAIDs) — either alone or in combination with other biologics, such as TNF-alpha inhibitors.

The findings were presented at the virtual European League Against Rheumatism (EULAR) 2020 Congress and were published online in Annals of the Rheumatic Diseases.

“Initially, there was a huge concern that these drugs could affect the outcome of patients getting COVID-19, but what this is showing is that probably these drugs do not increase their risk of severe outcome,” Machado, who is chair of the EULAR standing committee on epidemiology and health services research, told Medscape Medical News.

As of June 1, 1061 patients from 28 participating countries had been entered into the EULAR COVID-19 database, which was launched as part of the international Global Rheumatology Alliance registry. Patient data are categorized by factors such as top rheumatology diagnosis, comorbidities, top-five COVID-19 symptoms, and DMARD therapy at the time of virus infection. Anonymized data will be shared with an international register based in the United States.

Machado’s team combined data from the EULAR and Global Rheumatology Alliance COVID-19 registries from March 24 to April 20. They looked at patient factors — such as age, sex, smoking status, rheumatic diagnosis, comorbidities, and rheumatic therapies — to examine the association of rheumatic therapies with hospitalization rates and COVID-19 disease course.

Of the 277 patients (46%) in the study cohort who required hospitalization, 55 (9%) died. But this finding shouldn’t be viewed as the true rate of hospitalization or death in patients with rheumatic disease and COVID-19, said Gerd Burmester, MD, from Charité–University Medicine Berlin.

“There’s tremendous bias in terms of more serious cases of COVID-19 being reported to the registries,” he explained, “because the mild cases won’t even show up at their rheumatologist’s office.”

“This can skew the idea that COVID-19 is much more dangerous to rheumatic patients than to the regular population,” Burmester told Medscape Medical News. “It scares the patients, obviously, but we believe this is not justified.”

It’s still unclear whether rituximab use raises the risk for severe COVID-19, he said. “It appears to be the only biologic for which the jury is still out,” he said.

“Anti-TNFs and anti-IL-6 drugs may even be beneficial, although we don’t have robust data,” he added.

The study can only highlight associations between rheumatic drugs and COVID-19 outcomes. “We cannot say there is a causal relationship between the findings,” Machado said.

Longer-term data, when available, should illuminate “more granular” aspects of COVID-19 outcomes in rheumatic patients, including their risks of requiring ventilation or developing a cytokine storm, he noted.

Burmester and Machado agree that research needs to continue as the pandemic rages on. But so far, “there are no data suggesting that, if you’re on a targeted, dedicated immunomodulator, your risk is higher to have a worse course of COVID-19 than the general population,” Burmester said.

“We simply didn’t know that when the pandemic started, and some patients even discontinued their drugs out of this fear,” he added. “It’s more reassuring than we originally thought.”

This article first appeared on Medscape.com.

For well over a decade the elevated risk of pneumonia from inhaled corticosteroids for moderate to very severe COPD has been well documented, although the pneumonia risks from different types of ICSs have not been well understood.

Researchers from Taiwan have taken a step in to investigate this question with a nationwide cohort study that reported inhalers with budesonide and beclomethasone may have a lower pneumonia risk than that of fluticasone propionate/salmeterol inhalers (CHEST. 2020;157:117-29).

The study is the first to include beclomethasone-containing inhalers in a comparison of ICS/long-acting beta2-agonist (LABA) fixed combinations to evaluate pneumonia risk, along with dose and drug properties, wrote Ting-Yu Chang, MS, of the Graduate Institute of Clinical Pharmacology at the College of Medicine, National Taiwan University in Taipei, and colleagues.

The study evaluated 42,393 people with COPD in the National Health Insurance Research Database who got at least two continuous prescriptions for three different types of inhalers:

• Budesonide/formoterol (BUD/FOR).
• Beclomethasone/formoterol (BEC/FOR).
• Fluticasone propionate/salmeterol (FLU/SAL).

The study included patients aged 40 years and older who used a metered-dose inhaler (MDI) or dry-powder inhaler (DPI) between January 2011 and June 2015.

Patient experience with adverse events (AEs) was a factor in risk stratification, Mr. Chang and colleagues noted. “For the comparison between the BEC/FOR MDI and FLU/SAL MDI, the lower risk associated with the BEC/FOR MDI was more prominent in patients without severe AE in the past year,” they wrote.

The study found that BUD/FOR DPI users had a 17% lower risk of severe pneumonia and a 12% lower risk of severe AEs than that of FLU/SAL DPI users. The risk difference in pneumonia remained significant after adjustment for the ICS-equivalent daily dose, but the spread for AEs didn’t.

BEC/FOR MDI users were 31% less likely to get severe pneumonia and 18% less likely to have severe AEs than were FLU/SAL MDI users, but that difference declined and became nonsignificant after adjustment for the ICS-equivalent daily dose.

The study also found that a high average daily dose (> 500 mcg/d) of FLU/SAL MDI carried a 66% greater risk of severe pneumonia, compared with that of low-dose users. Also, medium-dose BEC/FOR MDI users (FLU equivalent 299-499 mcg/d) had a 38% greater risk of severe pneumonia than low-dose (< 200 mcg/d) users.

The variable pneumonia risks may be linked to each ICS’s pharmacokinetics, specifically their distinct lipophilic properties, Mr. Chang and colleagues wrote. Fluticasone propionate is known to be more lipophilic than budesonide, and while beclomethasone is more lipophilic than both, as a prodrug it rapidly converts to lower lipophilicity upon contact with bronchial secretions. “In general, a lipophilic ICS has a longer retention time within the airway or lung tissue to exert local immunosuppression and reduce inflammation,” Mr. Chang and colleagues stated.

The Taiwan Ministry of Science and Technology provided partial support for the study. Mr. Chang and colleagues have no relationships to disclose.

SOURCE: Chang TY et al. CHEST. 2020;157:117-29.

For well over a decade the elevated risk of pneumonia from inhaled corticosteroids for moderate to very severe COPD has been well documented, although the pneumonia risks from different types of ICSs have not been well understood.

Researchers from Taiwan have taken a step in to investigate this question with a nationwide cohort study that reported inhalers with budesonide and beclomethasone may have a lower pneumonia risk than that of fluticasone propionate/salmeterol inhalers (CHEST. 2020;157:117-29).

The study is the first to include beclomethasone-containing inhalers in a comparison of ICS/long-acting beta2-agonist (LABA) fixed combinations to evaluate pneumonia risk, along with dose and drug properties, wrote Ting-Yu Chang, MS, of the Graduate Institute of Clinical Pharmacology at the College of Medicine, National Taiwan University in Taipei, and colleagues.

The study evaluated 42,393 people with COPD in the National Health Insurance Research Database who got at least two continuous prescriptions for three different types of inhalers:

• Budesonide/formoterol (BUD/FOR).
• Beclomethasone/formoterol (BEC/FOR).
• Fluticasone propionate/salmeterol (FLU/SAL).

The study included patients aged 40 years and older who used a metered-dose inhaler (MDI) or dry-powder inhaler (DPI) between January 2011 and June 2015.

Patient experience with adverse events (AEs) was a factor in risk stratification, Mr. Chang and colleagues noted. “For the comparison between the BEC/FOR MDI and FLU/SAL MDI, the lower risk associated with the BEC/FOR MDI was more prominent in patients without severe AE in the past year,” they wrote.

The study found that BUD/FOR DPI users had a 17% lower risk of severe pneumonia and a 12% lower risk of severe AEs than that of FLU/SAL DPI users. The risk difference in pneumonia remained significant after adjustment for the ICS-equivalent daily dose, but the spread for AEs didn’t.

BEC/FOR MDI users were 31% less likely to get severe pneumonia and 18% less likely to have severe AEs than were FLU/SAL MDI users, but that difference declined and became nonsignificant after adjustment for the ICS-equivalent daily dose.

The study also found that a high average daily dose (> 500 mcg/d) of FLU/SAL MDI carried a 66% greater risk of severe pneumonia, compared with that of low-dose users. Also, medium-dose BEC/FOR MDI users (FLU equivalent 299-499 mcg/d) had a 38% greater risk of severe pneumonia than low-dose (< 200 mcg/d) users.

The variable pneumonia risks may be linked to each ICS’s pharmacokinetics, specifically their distinct lipophilic properties, Mr. Chang and colleagues wrote. Fluticasone propionate is known to be more lipophilic than budesonide, and while beclomethasone is more lipophilic than both, as a prodrug it rapidly converts to lower lipophilicity upon contact with bronchial secretions. “In general, a lipophilic ICS has a longer retention time within the airway or lung tissue to exert local immunosuppression and reduce inflammation,” Mr. Chang and colleagues stated.

The Taiwan Ministry of Science and Technology provided partial support for the study. Mr. Chang and colleagues have no relationships to disclose.

SOURCE: Chang TY et al. CHEST. 2020;157:117-29.

For well over a decade the elevated risk of pneumonia from inhaled corticosteroids for moderate to very severe COPD has been well documented, although the pneumonia risks from different types of ICSs have not been well understood.

Researchers from Taiwan have taken a step in to investigate this question with a nationwide cohort study that reported inhalers with budesonide and beclomethasone may have a lower pneumonia risk than that of fluticasone propionate/salmeterol inhalers (CHEST. 2020;157:117-29).

The study is the first to include beclomethasone-containing inhalers in a comparison of ICS/long-acting beta2-agonist (LABA) fixed combinations to evaluate pneumonia risk, along with dose and drug properties, wrote Ting-Yu Chang, MS, of the Graduate Institute of Clinical Pharmacology at the College of Medicine, National Taiwan University in Taipei, and colleagues.

The study evaluated 42,393 people with COPD in the National Health Insurance Research Database who got at least two continuous prescriptions for three different types of inhalers:

• Budesonide/formoterol (BUD/FOR).
• Beclomethasone/formoterol (BEC/FOR).
• Fluticasone propionate/salmeterol (FLU/SAL).

The study included patients aged 40 years and older who used a metered-dose inhaler (MDI) or dry-powder inhaler (DPI) between January 2011 and June 2015.

Patient experience with adverse events (AEs) was a factor in risk stratification, Mr. Chang and colleagues noted. “For the comparison between the BEC/FOR MDI and FLU/SAL MDI, the lower risk associated with the BEC/FOR MDI was more prominent in patients without severe AE in the past year,” they wrote.

The study found that BUD/FOR DPI users had a 17% lower risk of severe pneumonia and a 12% lower risk of severe AEs than that of FLU/SAL DPI users. The risk difference in pneumonia remained significant after adjustment for the ICS-equivalent daily dose, but the spread for AEs didn’t.

BEC/FOR MDI users were 31% less likely to get severe pneumonia and 18% less likely to have severe AEs than were FLU/SAL MDI users, but that difference declined and became nonsignificant after adjustment for the ICS-equivalent daily dose.

The study also found that a high average daily dose (> 500 mcg/d) of FLU/SAL MDI carried a 66% greater risk of severe pneumonia, compared with that of low-dose users. Also, medium-dose BEC/FOR MDI users (FLU equivalent 299-499 mcg/d) had a 38% greater risk of severe pneumonia than low-dose (< 200 mcg/d) users.

The variable pneumonia risks may be linked to each ICS’s pharmacokinetics, specifically their distinct lipophilic properties, Mr. Chang and colleagues wrote. Fluticasone propionate is known to be more lipophilic than budesonide, and while beclomethasone is more lipophilic than both, as a prodrug it rapidly converts to lower lipophilicity upon contact with bronchial secretions. “In general, a lipophilic ICS has a longer retention time within the airway or lung tissue to exert local immunosuppression and reduce inflammation,” Mr. Chang and colleagues stated.

The Taiwan Ministry of Science and Technology provided partial support for the study. Mr. Chang and colleagues have no relationships to disclose.

SOURCE: Chang TY et al. CHEST. 2020;157:117-29.

Parents of children with significant special needs know a thing or two about what the population in general has been experiencing since the pandemic took hold of the nation. The last few months have tested the stamina of most families. Many people are struggling to keep some semblance of normalcy amid a radical transformation of everyday life. It seems as if everything changed overnight.

Jupiterimages/Thinkstock

In a similar way, when a child with many needs is born into a family, adjustments also have to take place to receive the new baby. Families are, in most cases, not prepared for what is to come. Their expectations usually are not in sync with how their lives end up. They are crunched for time. They need to adjust, and at the same time, they mourn the loss of their previous less demanding lifestyle. More importantly, these parents learn that this might be an adjustment that they might need to make for a long time – in some instances, for a lifetime.

Stress load over time can correlate with a sense of burnout, and mental health professionals need to be prepared to address these issues in our patients.

Here is a list of some chronic struggles with which many special needs parents must contend. These strongly resemble the challenges parents in the general population have been facing with their families during this pandemic:

• Bypassing breaks to unwind and having to be always “on” while at home: These parents take care of children who need to be chronically tube fed, can’t sleep well at night because they are often sick, have recurrent seizures or maladaptive behaviors that affect the caretakers and the rest of the family. For parents of children who are on the autism spectrum, these challenges can be a constant struggle. Almost 60% of children with autism spectrum disorder (ASD) experience bodily difficulties, such as trouble breathing. However, nearly 100% of children with ASD experienced difficulties with their abilities and activities, such as self-care tasks like eating and dressing, and emotional or behavioral health, according to a 2016 report on child and adolescent health by the Johns Hopkins Bloomberg School of Public Health.
• Taking on roles for which they are not trained: Parents may take on active roles supplementing their developmentally delayed children with educational experiences or therapeutic modalities in their own homes given that the needs might be too great to just rely on the school or therapy time. There are about 1.17 million children in the United States living with ASD and more than 12% of children with ASD have severe cases, the Hopkins report said. Parents frequently are forced to take on the role of “therapist” to meet the needs of their child.
• Staying home often: Some parents are unable to have a “regular sitter” to provide respite, because the needs of the child require a higher level of care, training, and consideration. Caring for a special child means parents often don’t have the option of leaving their older child alone. As a result, they may end up spending more time at home than their counterpart parents with children who are the same age.
• Struggling to meet everyone’s demands for attention while at home: The child might require full-time attention or prolonged hospitalizations, and the needs of other siblings are sometimes put on hold until time or energy are available for all.
• Not traveling unless absolutely necessary: Families have a hard time leaving home for vacations or for other reasons. They may have to travel with medical supplies and equipment. They need to make sure that their destination is ready to welcome their child with all needs taken into consideration (special diets, activities, and facilities). Will the vacation set them back because it might take more effort to go than to stay home?
• Avoiding unnecessary exposures: Trying to avoid infections (even the ones that may be innocuous to others) if their child is immunocompromised. These children may readily decompensate and end up hospitalized with a more serious medical complication.
• Being very aware of remaining physically distant from others: Parents must go to great lengths not to impinge on other people’s space if the child is being loud or moving in a disruptive way, or if other people negatively affect how the child responds. Some families are apprehensive because they have felt judged by others when they are in the community, restaurants, or other places of gathering.
• Feeling concerned about having the right food, medicines, and supplements in the house: Parents are constantly trying to fulfill special dietary requirements and have the reserve to make sure that all meals and treatments are accounted for in the near future. They might need oxygen or specialized formulas that are hard to find in local stores. Some treatments, when withdrawn or unavailable, can prove life threatening.
• Restricting social circles: Some families with children with severe autism may self-isolate when they feel it is hard to be around them and be friends with them, since they can’t readily participate in “usual family activities,” and the regular norms of socialization can’t apply to their family’s set of behaviors. Their child might seem to be disruptive, or loud, nonverbal, mute, or unable to easily relate to others.
• Experiencing a pervasive sense of uncertainty about the future: A child might continue to miss milestones, or might have a rare condition that hasn’t been diagnosed. When thinking of the future, parents can’t predict what level of care they need to plan and budget for.
• Being concerned about dying early and not being able to provide for their child: Parents worry about who would take care of their child for life. Who would take care of their aging adult “child” after parents are gone? They might have concerns about having a will in place early on.
• Facing financial stress secondary to losing a job or the cost of treatments: Absenteeism might be the end result of having to care for their child’s ongoing needs, appointments, and medical emergencies. Sometimes, they might depend on a caretaker who might be very difficult to replace. It might take extensive training once a candidate is found. Direct costs include medical care, hospitalizations, special education, special therapies (occupational, speech, and physical therapy), and paid caregivers. Indirect costs include lost productivity for family caregivers because of the inability to maintain employment while caring for affected individuals, as well as lost wages and benefits, the Hopkins report said.
• Struggling to coordinate daily schedules: Parents face this challenge not only with young children but with those who are chronically ill and might need ongoing 24/7 care. The schedule might include educational and therapeutic (physical, occupational, speech, language therapy, recreational) interventions regularly or daily. This schedule is to be superimposed on all the other necessary responsibilities parents already have to contend with. Forty-eight percent of school-aged children with ASD use three or more services. In addition, children with moderate or severe cases of ASD used three or more services at almost twice the rate of children with mild cases of ASD (60% vs. 35%).
• Longing for a cure or a medicine that will improve the outcome: Often, parents search for treatments so that their child could live a more comfortable or healthier life. For children who have a rare condition, there may not be sufficient research dedicated to their cause or diagnostic pursuits. Currently, it is estimated that 1 in 10 Americans has a rare disease – about 80% of which are genetically based. Of the nearly 7,000 rare diseases known to exist, less than 500 – roughly 5% – have a known treatment approved by the U.S. Food and Drug Administration, reports the National Center for Advancing Translational Diseases and the Genetic and Rare Diseases Information Center.
• Hoping for better times to come: It is difficult at times to appreciate the present when it happens to be so chronically challenging and exhausting for everyone.

Parents of children with significant special needs experience many hurdles that they learn to endure, overcome, and master. This pandemic can provide physicians with a window into the lives of these families.
 

Dr. Sotir is a psychiatrist in private practice in Wheaton, Ill. As a parent of three children, one with special needs, she has extensive experience helping parents challenged by having special needs children find balance, support, direction, and joy in all dimensions of individual and family life. This area is the focus of her practice and public speaking. In Part 2, she will explore how psychiatrists as a specialty can support these families. She has no disclosures.

Parents of children with significant special needs know a thing or two about what the population in general has been experiencing since the pandemic took hold of the nation. The last few months have tested the stamina of most families. Many people are struggling to keep some semblance of normalcy amid a radical transformation of everyday life. It seems as if everything changed overnight.

Jupiterimages/Thinkstock

In a similar way, when a child with many needs is born into a family, adjustments also have to take place to receive the new baby. Families are, in most cases, not prepared for what is to come. Their expectations usually are not in sync with how their lives end up. They are crunched for time. They need to adjust, and at the same time, they mourn the loss of their previous less demanding lifestyle. More importantly, these parents learn that this might be an adjustment that they might need to make for a long time – in some instances, for a lifetime.

Stress load over time can correlate with a sense of burnout, and mental health professionals need to be prepared to address these issues in our patients.

Here is a list of some chronic struggles with which many special needs parents must contend. These strongly resemble the challenges parents in the general population have been facing with their families during this pandemic:

• Bypassing breaks to unwind and having to be always “on” while at home: These parents take care of children who need to be chronically tube fed, can’t sleep well at night because they are often sick, have recurrent seizures or maladaptive behaviors that affect the caretakers and the rest of the family. For parents of children who are on the autism spectrum, these challenges can be a constant struggle. Almost 60% of children with autism spectrum disorder (ASD) experience bodily difficulties, such as trouble breathing. However, nearly 100% of children with ASD experienced difficulties with their abilities and activities, such as self-care tasks like eating and dressing, and emotional or behavioral health, according to a 2016 report on child and adolescent health by the Johns Hopkins Bloomberg School of Public Health.
• Taking on roles for which they are not trained: Parents may take on active roles supplementing their developmentally delayed children with educational experiences or therapeutic modalities in their own homes given that the needs might be too great to just rely on the school or therapy time. There are about 1.17 million children in the United States living with ASD and more than 12% of children with ASD have severe cases, the Hopkins report said. Parents frequently are forced to take on the role of “therapist” to meet the needs of their child.
• Staying home often: Some parents are unable to have a “regular sitter” to provide respite, because the needs of the child require a higher level of care, training, and consideration. Caring for a special child means parents often don’t have the option of leaving their older child alone. As a result, they may end up spending more time at home than their counterpart parents with children who are the same age.
• Struggling to meet everyone’s demands for attention while at home: The child might require full-time attention or prolonged hospitalizations, and the needs of other siblings are sometimes put on hold until time or energy are available for all.
• Not traveling unless absolutely necessary: Families have a hard time leaving home for vacations or for other reasons. They may have to travel with medical supplies and equipment. They need to make sure that their destination is ready to welcome their child with all needs taken into consideration (special diets, activities, and facilities). Will the vacation set them back because it might take more effort to go than to stay home?
• Avoiding unnecessary exposures: Trying to avoid infections (even the ones that may be innocuous to others) if their child is immunocompromised. These children may readily decompensate and end up hospitalized with a more serious medical complication.
• Being very aware of remaining physically distant from others: Parents must go to great lengths not to impinge on other people’s space if the child is being loud or moving in a disruptive way, or if other people negatively affect how the child responds. Some families are apprehensive because they have felt judged by others when they are in the community, restaurants, or other places of gathering.
• Feeling concerned about having the right food, medicines, and supplements in the house: Parents are constantly trying to fulfill special dietary requirements and have the reserve to make sure that all meals and treatments are accounted for in the near future. They might need oxygen or specialized formulas that are hard to find in local stores. Some treatments, when withdrawn or unavailable, can prove life threatening.
• Restricting social circles: Some families with children with severe autism may self-isolate when they feel it is hard to be around them and be friends with them, since they can’t readily participate in “usual family activities,” and the regular norms of socialization can’t apply to their family’s set of behaviors. Their child might seem to be disruptive, or loud, nonverbal, mute, or unable to easily relate to others.
• Experiencing a pervasive sense of uncertainty about the future: A child might continue to miss milestones, or might have a rare condition that hasn’t been diagnosed. When thinking of the future, parents can’t predict what level of care they need to plan and budget for.
• Being concerned about dying early and not being able to provide for their child: Parents worry about who would take care of their child for life. Who would take care of their aging adult “child” after parents are gone? They might have concerns about having a will in place early on.
• Facing financial stress secondary to losing a job or the cost of treatments: Absenteeism might be the end result of having to care for their child’s ongoing needs, appointments, and medical emergencies. Sometimes, they might depend on a caretaker who might be very difficult to replace. It might take extensive training once a candidate is found. Direct costs include medical care, hospitalizations, special education, special therapies (occupational, speech, and physical therapy), and paid caregivers. Indirect costs include lost productivity for family caregivers because of the inability to maintain employment while caring for affected individuals, as well as lost wages and benefits, the Hopkins report said.
• Struggling to coordinate daily schedules: Parents face this challenge not only with young children but with those who are chronically ill and might need ongoing 24/7 care. The schedule might include educational and therapeutic (physical, occupational, speech, language therapy, recreational) interventions regularly or daily. This schedule is to be superimposed on all the other necessary responsibilities parents already have to contend with. Forty-eight percent of school-aged children with ASD use three or more services. In addition, children with moderate or severe cases of ASD used three or more services at almost twice the rate of children with mild cases of ASD (60% vs. 35%).
• Longing for a cure or a medicine that will improve the outcome: Often, parents search for treatments so that their child could live a more comfortable or healthier life. For children who have a rare condition, there may not be sufficient research dedicated to their cause or diagnostic pursuits. Currently, it is estimated that 1 in 10 Americans has a rare disease – about 80% of which are genetically based. Of the nearly 7,000 rare diseases known to exist, less than 500 – roughly 5% – have a known treatment approved by the U.S. Food and Drug Administration, reports the National Center for Advancing Translational Diseases and the Genetic and Rare Diseases Information Center.
• Hoping for better times to come: It is difficult at times to appreciate the present when it happens to be so chronically challenging and exhausting for everyone.

Parents of children with significant special needs experience many hurdles that they learn to endure, overcome, and master. This pandemic can provide physicians with a window into the lives of these families.
 

Dr. Sotir is a psychiatrist in private practice in Wheaton, Ill. As a parent of three children, one with special needs, she has extensive experience helping parents challenged by having special needs children find balance, support, direction, and joy in all dimensions of individual and family life. This area is the focus of her practice and public speaking. In Part 2, she will explore how psychiatrists as a specialty can support these families. She has no disclosures.

Parents of children with significant special needs know a thing or two about what the population in general has been experiencing since the pandemic took hold of the nation. The last few months have tested the stamina of most families. Many people are struggling to keep some semblance of normalcy amid a radical transformation of everyday life. It seems as if everything changed overnight.

Jupiterimages/Thinkstock

In a similar way, when a child with many needs is born into a family, adjustments also have to take place to receive the new baby. Families are, in most cases, not prepared for what is to come. Their expectations usually are not in sync with how their lives end up. They are crunched for time. They need to adjust, and at the same time, they mourn the loss of their previous less demanding lifestyle. More importantly, these parents learn that this might be an adjustment that they might need to make for a long time – in some instances, for a lifetime.

Stress load over time can correlate with a sense of burnout, and mental health professionals need to be prepared to address these issues in our patients.

Here is a list of some chronic struggles with which many special needs parents must contend. These strongly resemble the challenges parents in the general population have been facing with their families during this pandemic:

• Bypassing breaks to unwind and having to be always “on” while at home: These parents take care of children who need to be chronically tube fed, can’t sleep well at night because they are often sick, have recurrent seizures or maladaptive behaviors that affect the caretakers and the rest of the family. For parents of children who are on the autism spectrum, these challenges can be a constant struggle. Almost 60% of children with autism spectrum disorder (ASD) experience bodily difficulties, such as trouble breathing. However, nearly 100% of children with ASD experienced difficulties with their abilities and activities, such as self-care tasks like eating and dressing, and emotional or behavioral health, according to a 2016 report on child and adolescent health by the Johns Hopkins Bloomberg School of Public Health.
• Taking on roles for which they are not trained: Parents may take on active roles supplementing their developmentally delayed children with educational experiences or therapeutic modalities in their own homes given that the needs might be too great to just rely on the school or therapy time. There are about 1.17 million children in the United States living with ASD and more than 12% of children with ASD have severe cases, the Hopkins report said. Parents frequently are forced to take on the role of “therapist” to meet the needs of their child.
• Staying home often: Some parents are unable to have a “regular sitter” to provide respite, because the needs of the child require a higher level of care, training, and consideration. Caring for a special child means parents often don’t have the option of leaving their older child alone. As a result, they may end up spending more time at home than their counterpart parents with children who are the same age.
• Struggling to meet everyone’s demands for attention while at home: The child might require full-time attention or prolonged hospitalizations, and the needs of other siblings are sometimes put on hold until time or energy are available for all.
• Not traveling unless absolutely necessary: Families have a hard time leaving home for vacations or for other reasons. They may have to travel with medical supplies and equipment. They need to make sure that their destination is ready to welcome their child with all needs taken into consideration (special diets, activities, and facilities). Will the vacation set them back because it might take more effort to go than to stay home?
• Avoiding unnecessary exposures: Trying to avoid infections (even the ones that may be innocuous to others) if their child is immunocompromised. These children may readily decompensate and end up hospitalized with a more serious medical complication.
• Being very aware of remaining physically distant from others: Parents must go to great lengths not to impinge on other people’s space if the child is being loud or moving in a disruptive way, or if other people negatively affect how the child responds. Some families are apprehensive because they have felt judged by others when they are in the community, restaurants, or other places of gathering.
• Feeling concerned about having the right food, medicines, and supplements in the house: Parents are constantly trying to fulfill special dietary requirements and have the reserve to make sure that all meals and treatments are accounted for in the near future. They might need oxygen or specialized formulas that are hard to find in local stores. Some treatments, when withdrawn or unavailable, can prove life threatening.
• Restricting social circles: Some families with children with severe autism may self-isolate when they feel it is hard to be around them and be friends with them, since they can’t readily participate in “usual family activities,” and the regular norms of socialization can’t apply to their family’s set of behaviors. Their child might seem to be disruptive, or loud, nonverbal, mute, or unable to easily relate to others.
• Experiencing a pervasive sense of uncertainty about the future: A child might continue to miss milestones, or might have a rare condition that hasn’t been diagnosed. When thinking of the future, parents can’t predict what level of care they need to plan and budget for.
• Being concerned about dying early and not being able to provide for their child: Parents worry about who would take care of their child for life. Who would take care of their aging adult “child” after parents are gone? They might have concerns about having a will in place early on.
• Facing financial stress secondary to losing a job or the cost of treatments: Absenteeism might be the end result of having to care for their child’s ongoing needs, appointments, and medical emergencies. Sometimes, they might depend on a caretaker who might be very difficult to replace. It might take extensive training once a candidate is found. Direct costs include medical care, hospitalizations, special education, special therapies (occupational, speech, and physical therapy), and paid caregivers. Indirect costs include lost productivity for family caregivers because of the inability to maintain employment while caring for affected individuals, as well as lost wages and benefits, the Hopkins report said.
• Struggling to coordinate daily schedules: Parents face this challenge not only with young children but with those who are chronically ill and might need ongoing 24/7 care. The schedule might include educational and therapeutic (physical, occupational, speech, language therapy, recreational) interventions regularly or daily. This schedule is to be superimposed on all the other necessary responsibilities parents already have to contend with. Forty-eight percent of school-aged children with ASD use three or more services. In addition, children with moderate or severe cases of ASD used three or more services at almost twice the rate of children with mild cases of ASD (60% vs. 35%).
• Longing for a cure or a medicine that will improve the outcome: Often, parents search for treatments so that their child could live a more comfortable or healthier life. For children who have a rare condition, there may not be sufficient research dedicated to their cause or diagnostic pursuits. Currently, it is estimated that 1 in 10 Americans has a rare disease – about 80% of which are genetically based. Of the nearly 7,000 rare diseases known to exist, less than 500 – roughly 5% – have a known treatment approved by the U.S. Food and Drug Administration, reports the National Center for Advancing Translational Diseases and the Genetic and Rare Diseases Information Center.
• Hoping for better times to come: It is difficult at times to appreciate the present when it happens to be so chronically challenging and exhausting for everyone.

Parents of children with significant special needs experience many hurdles that they learn to endure, overcome, and master. This pandemic can provide physicians with a window into the lives of these families.
 

Dr. Sotir is a psychiatrist in private practice in Wheaton, Ill. As a parent of three children, one with special needs, she has extensive experience helping parents challenged by having special needs children find balance, support, direction, and joy in all dimensions of individual and family life. This area is the focus of her practice and public speaking. In Part 2, she will explore how psychiatrists as a specialty can support these families. She has no disclosures.

COVID-19 infection is associated with a high risk for mortality in heart transplant (HT) recipients, a new case series suggests.

Investigators looked at data on 28 patients with a confirmed diagnosis of COVID-19 who received a HT between March 1, 2020, and April 24, 2020 and found a case-fatality rate of 25%.

“The high case fatality in our case series should alert physicians to the vulnerability of heart transplant recipients during the COVID-19 pandemic,” senior author Nir Uriel, MD, MSc, professor of medicine at Columbia University, New York, said in an interview.

“These patients require extra precautions to prevent the development of infection,” said Dr. Uriel, who is also a cardiologist at New York Presbyterian/Columbia University Irving Medical Center.

The study was published online May 13 in JAMA Cardiology.
 

Similar presentation

HT recipients can have several comorbidities after the procedure, including hypertension, diabetes, cardiac allograft vasculopathy, and ongoing immunosuppression, all of which can place them at risk for infection and adverse outcomes with COVID-19 infection, the authors wrote.

The researchers therefore embarked on a case series looking at 28 HT recipients with COVID-19 infection (median age, 64.0 years; interquartile range, 53.5-70.5; 79% male) to “describe the outcomes of recipients of HT who are chronically immunosuppressed and develop COVID-19 and raise important questions about the role of the immune system in the process.”

The median time from HT to study period was 8.6 (IQR, 4.2-14.5) years. Most patients had numerous comorbidities.

Medscape.com

No protective effect

Twenty-two patients (79%) required admission to the hospital, seven of whom (25%) required admission to the ICU and mechanical ventilation.

Despite the presence of immunosuppressive therapy, all patients had significant elevation of inflammatory biomarkers (median peak high-sensitivity C-reactive protein [hs-CRP], 11.83 mg/dL; IQR, 7.44-19.26; median peak interleukin [IL]-6, 105 pg/mL; IQR, 38-296).

Three-quarters had myocardial injury, with a median high-sensitivity troponin T of 0.055 (0.0205 - 0.1345) ng/mL.

Treatments of COVID-19 included hydroxychloroquine (18 patients; 78%), high-dose corticosteroids (eight patients; 47%), and IL-6 receptor antagonists (six patients; 26%).

Moreover, during hospitalization, mycophenolate mofetil was discontinued in most (70%) patients, and one-quarter had a reduction in their calcineurin inhibitor dose.

“Heart transplant recipients generally require more intense immunosuppressive therapy than most other solid organ transplant recipients, and this high baseline immunosuppression increases their propensity to develop infections and their likelihood of experiencing severe manifestations of infections,” Dr. Uriel commented.

“With COVID-19, in which the body’s inflammatory reaction appears to play a role in disease severity, there has been a question of whether immunosuppression may offer a protective effect,” he continued.

“This case series suggests that this is not the case, although this would need to be confirmed in larger studies,” he said.
 

Low threshold

Among the 22 patients who were admitted to the hospital, half were discharged home and four (18%) were still hospitalized at the end of the study.

Of the seven patients who died, two died at the study center, and five died in an outside institution.

“In the HT population, social distancing (or isolation), strict use of masks when in public, proper handwashing, and sanitization of surfaces are of paramount importance in the prevention of COVID-19 infection,” Dr. Uriel stated.

“In addition, we have restricted these patients’ contact with the hospital as much as possible during the pandemic,” he said.

However, “there should be a low threshold to hospitalize heart transplant patients who develop infection with COVID-19. Furthermore, in our series, outcomes were better for patients hospitalized at the transplant center; therefore, strong consideration should be given to transferring HT patients when hospitalized at another hospital,” he added.

The authors emphasized that COVID-19 patients “will require ongoing monitoring in the recovery phase, as an immunosuppression regimen is reintroduced and the consequences to the allograft itself become apparent.”
 

Vulnerable population

Commenting on the study, Mandeep R. Mehra, MD, MSc, William Harvey Distinguished Chair in Advanced Cardiovascular Medicine at Brigham and Women’s Hospital, Boston, suggested that “in epidemiological terms, [the findings] might not look as bad as the way they are reflected in the paper.”

Given that Columbia is “one of the larger heart transplant centers in the U.S., following probably 1,000 patients, having only 22 out of perhaps thousands whom they transplanted or are actively following would actually represent a low serious infection rate,” said Dr. Mehra, who is also the executive director of the Center for Advanced Heart Disease at Brigham and Women’s Hospital and a professor of medicine at Harvard Medical School, also in Boston.

“We must not forget to emphasize that, when assessing these case fatality rates, we must look at the entire population at risk, not only the handful that we were able to observe,” explained Dr. Mehra, who was not involved with the study.

Moreover, the patients were “older and had comorbidities, with poor underlying kidney function and other complications, and underlying coronary artery disease in the transplanted heart,” so “it would not surprise me that they had such a high fatality rate, since they had a high degree of vulnerability,” he said.

Dr. Mehra, who is also the editor-in-chief of the Journal of Heart and Lung Transplantation, said that the journal has received manuscripts still in the review process that suggest different fatality rates than those found in the current case series.

However, he acknowledged that, because these are patients with serious vulnerability due to underlying heart disease, “you can’t be lackadaisical and need to do everything to decrease this vulnerability.”

The authors noted that, although their study did not show a protective effect from immunosuppression against COVID-19, further studies are needed to assess each individual immunosuppressive agent and provide a definitive answer.

The study was supported by a grant to one of the investigators from the National Heart, Lung, and Blood Institute. Dr. Uriel reports no relevant financial relationships. The other authors’ disclosures are listed in the publication. Dr. Mehra reports no relevant financial relationships.

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

COVID-19 infection is associated with a high risk for mortality in heart transplant (HT) recipients, a new case series suggests.

Investigators looked at data on 28 patients with a confirmed diagnosis of COVID-19 who received a HT between March 1, 2020, and April 24, 2020 and found a case-fatality rate of 25%.

“The high case fatality in our case series should alert physicians to the vulnerability of heart transplant recipients during the COVID-19 pandemic,” senior author Nir Uriel, MD, MSc, professor of medicine at Columbia University, New York, said in an interview.

“These patients require extra precautions to prevent the development of infection,” said Dr. Uriel, who is also a cardiologist at New York Presbyterian/Columbia University Irving Medical Center.

The study was published online May 13 in JAMA Cardiology.
 

Similar presentation

HT recipients can have several comorbidities after the procedure, including hypertension, diabetes, cardiac allograft vasculopathy, and ongoing immunosuppression, all of which can place them at risk for infection and adverse outcomes with COVID-19 infection, the authors wrote.

The researchers therefore embarked on a case series looking at 28 HT recipients with COVID-19 infection (median age, 64.0 years; interquartile range, 53.5-70.5; 79% male) to “describe the outcomes of recipients of HT who are chronically immunosuppressed and develop COVID-19 and raise important questions about the role of the immune system in the process.”

The median time from HT to study period was 8.6 (IQR, 4.2-14.5) years. Most patients had numerous comorbidities.

Medscape.com

No protective effect

Twenty-two patients (79%) required admission to the hospital, seven of whom (25%) required admission to the ICU and mechanical ventilation.

Despite the presence of immunosuppressive therapy, all patients had significant elevation of inflammatory biomarkers (median peak high-sensitivity C-reactive protein [hs-CRP], 11.83 mg/dL; IQR, 7.44-19.26; median peak interleukin [IL]-6, 105 pg/mL; IQR, 38-296).

Three-quarters had myocardial injury, with a median high-sensitivity troponin T of 0.055 (0.0205 - 0.1345) ng/mL.

Treatments of COVID-19 included hydroxychloroquine (18 patients; 78%), high-dose corticosteroids (eight patients; 47%), and IL-6 receptor antagonists (six patients; 26%).

Moreover, during hospitalization, mycophenolate mofetil was discontinued in most (70%) patients, and one-quarter had a reduction in their calcineurin inhibitor dose.

“Heart transplant recipients generally require more intense immunosuppressive therapy than most other solid organ transplant recipients, and this high baseline immunosuppression increases their propensity to develop infections and their likelihood of experiencing severe manifestations of infections,” Dr. Uriel commented.

“With COVID-19, in which the body’s inflammatory reaction appears to play a role in disease severity, there has been a question of whether immunosuppression may offer a protective effect,” he continued.

“This case series suggests that this is not the case, although this would need to be confirmed in larger studies,” he said.
 

Low threshold

Among the 22 patients who were admitted to the hospital, half were discharged home and four (18%) were still hospitalized at the end of the study.

Of the seven patients who died, two died at the study center, and five died in an outside institution.

“In the HT population, social distancing (or isolation), strict use of masks when in public, proper handwashing, and sanitization of surfaces are of paramount importance in the prevention of COVID-19 infection,” Dr. Uriel stated.

“In addition, we have restricted these patients’ contact with the hospital as much as possible during the pandemic,” he said.

However, “there should be a low threshold to hospitalize heart transplant patients who develop infection with COVID-19. Furthermore, in our series, outcomes were better for patients hospitalized at the transplant center; therefore, strong consideration should be given to transferring HT patients when hospitalized at another hospital,” he added.

The authors emphasized that COVID-19 patients “will require ongoing monitoring in the recovery phase, as an immunosuppression regimen is reintroduced and the consequences to the allograft itself become apparent.”
 

Vulnerable population

Commenting on the study, Mandeep R. Mehra, MD, MSc, William Harvey Distinguished Chair in Advanced Cardiovascular Medicine at Brigham and Women’s Hospital, Boston, suggested that “in epidemiological terms, [the findings] might not look as bad as the way they are reflected in the paper.”

Given that Columbia is “one of the larger heart transplant centers in the U.S., following probably 1,000 patients, having only 22 out of perhaps thousands whom they transplanted or are actively following would actually represent a low serious infection rate,” said Dr. Mehra, who is also the executive director of the Center for Advanced Heart Disease at Brigham and Women’s Hospital and a professor of medicine at Harvard Medical School, also in Boston.

“We must not forget to emphasize that, when assessing these case fatality rates, we must look at the entire population at risk, not only the handful that we were able to observe,” explained Dr. Mehra, who was not involved with the study.

Moreover, the patients were “older and had comorbidities, with poor underlying kidney function and other complications, and underlying coronary artery disease in the transplanted heart,” so “it would not surprise me that they had such a high fatality rate, since they had a high degree of vulnerability,” he said.

Dr. Mehra, who is also the editor-in-chief of the Journal of Heart and Lung Transplantation, said that the journal has received manuscripts still in the review process that suggest different fatality rates than those found in the current case series.

However, he acknowledged that, because these are patients with serious vulnerability due to underlying heart disease, “you can’t be lackadaisical and need to do everything to decrease this vulnerability.”

The authors noted that, although their study did not show a protective effect from immunosuppression against COVID-19, further studies are needed to assess each individual immunosuppressive agent and provide a definitive answer.

The study was supported by a grant to one of the investigators from the National Heart, Lung, and Blood Institute. Dr. Uriel reports no relevant financial relationships. The other authors’ disclosures are listed in the publication. Dr. Mehra reports no relevant financial relationships.

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

COVID-19 infection is associated with a high risk for mortality in heart transplant (HT) recipients, a new case series suggests.

Investigators looked at data on 28 patients with a confirmed diagnosis of COVID-19 who received a HT between March 1, 2020, and April 24, 2020 and found a case-fatality rate of 25%.

“The high case fatality in our case series should alert physicians to the vulnerability of heart transplant recipients during the COVID-19 pandemic,” senior author Nir Uriel, MD, MSc, professor of medicine at Columbia University, New York, said in an interview.

“These patients require extra precautions to prevent the development of infection,” said Dr. Uriel, who is also a cardiologist at New York Presbyterian/Columbia University Irving Medical Center.

The study was published online May 13 in JAMA Cardiology.
 

Similar presentation

HT recipients can have several comorbidities after the procedure, including hypertension, diabetes, cardiac allograft vasculopathy, and ongoing immunosuppression, all of which can place them at risk for infection and adverse outcomes with COVID-19 infection, the authors wrote.

The researchers therefore embarked on a case series looking at 28 HT recipients with COVID-19 infection (median age, 64.0 years; interquartile range, 53.5-70.5; 79% male) to “describe the outcomes of recipients of HT who are chronically immunosuppressed and develop COVID-19 and raise important questions about the role of the immune system in the process.”

The median time from HT to study period was 8.6 (IQR, 4.2-14.5) years. Most patients had numerous comorbidities.

Medscape.com

No protective effect

Twenty-two patients (79%) required admission to the hospital, seven of whom (25%) required admission to the ICU and mechanical ventilation.

Despite the presence of immunosuppressive therapy, all patients had significant elevation of inflammatory biomarkers (median peak high-sensitivity C-reactive protein [hs-CRP], 11.83 mg/dL; IQR, 7.44-19.26; median peak interleukin [IL]-6, 105 pg/mL; IQR, 38-296).

Three-quarters had myocardial injury, with a median high-sensitivity troponin T of 0.055 (0.0205 - 0.1345) ng/mL.

Treatments of COVID-19 included hydroxychloroquine (18 patients; 78%), high-dose corticosteroids (eight patients; 47%), and IL-6 receptor antagonists (six patients; 26%).

Moreover, during hospitalization, mycophenolate mofetil was discontinued in most (70%) patients, and one-quarter had a reduction in their calcineurin inhibitor dose.

“Heart transplant recipients generally require more intense immunosuppressive therapy than most other solid organ transplant recipients, and this high baseline immunosuppression increases their propensity to develop infections and their likelihood of experiencing severe manifestations of infections,” Dr. Uriel commented.

“With COVID-19, in which the body’s inflammatory reaction appears to play a role in disease severity, there has been a question of whether immunosuppression may offer a protective effect,” he continued.

“This case series suggests that this is not the case, although this would need to be confirmed in larger studies,” he said.
 

Low threshold

Among the 22 patients who were admitted to the hospital, half were discharged home and four (18%) were still hospitalized at the end of the study.

Of the seven patients who died, two died at the study center, and five died in an outside institution.

“In the HT population, social distancing (or isolation), strict use of masks when in public, proper handwashing, and sanitization of surfaces are of paramount importance in the prevention of COVID-19 infection,” Dr. Uriel stated.

“In addition, we have restricted these patients’ contact with the hospital as much as possible during the pandemic,” he said.

However, “there should be a low threshold to hospitalize heart transplant patients who develop infection with COVID-19. Furthermore, in our series, outcomes were better for patients hospitalized at the transplant center; therefore, strong consideration should be given to transferring HT patients when hospitalized at another hospital,” he added.

The authors emphasized that COVID-19 patients “will require ongoing monitoring in the recovery phase, as an immunosuppression regimen is reintroduced and the consequences to the allograft itself become apparent.”
 

Vulnerable population

Commenting on the study, Mandeep R. Mehra, MD, MSc, William Harvey Distinguished Chair in Advanced Cardiovascular Medicine at Brigham and Women’s Hospital, Boston, suggested that “in epidemiological terms, [the findings] might not look as bad as the way they are reflected in the paper.”

Given that Columbia is “one of the larger heart transplant centers in the U.S., following probably 1,000 patients, having only 22 out of perhaps thousands whom they transplanted or are actively following would actually represent a low serious infection rate,” said Dr. Mehra, who is also the executive director of the Center for Advanced Heart Disease at Brigham and Women’s Hospital and a professor of medicine at Harvard Medical School, also in Boston.

“We must not forget to emphasize that, when assessing these case fatality rates, we must look at the entire population at risk, not only the handful that we were able to observe,” explained Dr. Mehra, who was not involved with the study.

Moreover, the patients were “older and had comorbidities, with poor underlying kidney function and other complications, and underlying coronary artery disease in the transplanted heart,” so “it would not surprise me that they had such a high fatality rate, since they had a high degree of vulnerability,” he said.

Dr. Mehra, who is also the editor-in-chief of the Journal of Heart and Lung Transplantation, said that the journal has received manuscripts still in the review process that suggest different fatality rates than those found in the current case series.

However, he acknowledged that, because these are patients with serious vulnerability due to underlying heart disease, “you can’t be lackadaisical and need to do everything to decrease this vulnerability.”

The authors noted that, although their study did not show a protective effect from immunosuppression against COVID-19, further studies are needed to assess each individual immunosuppressive agent and provide a definitive answer.

The study was supported by a grant to one of the investigators from the National Heart, Lung, and Blood Institute. Dr. Uriel reports no relevant financial relationships. The other authors’ disclosures are listed in the publication. Dr. Mehra reports no relevant financial relationships.

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

During a 4-week period early in the COVID-19 pandemic, visits to U.S. emergency departments were down by 42%, compared with the corresponding period in 2019, according to a report from the Centers for Disease Control and Prevention.

“The striking decline in ED visits nationwide … suggests that the pandemic has altered the use of the ED by the public,” Kathleen P. Hartnett, PhD, and associates at the CDC said June 3 in the Mortality and Morbidity Weekly Report.

The weekly mean was just over 1.2 million ED visits for the 4 weeks from March 29 to April 25, 2020, compared with the nearly 2.2 million visits per week recorded from March 31 to April 27, 2019 – a drop of 42%, based on an analysis of data from the National Syndromic Surveillance Program.

Despite that drop, ED visits for infectious disease–related reasons, taken as a proportion of all 1.2 ED visits during the early pandemic period, were 3.8 times higher than the comparison period in 2019, the investigators reported.

ED visits also were higher in 2020 for specified and unspecified lower respiratory disease not including influenza, pneumonia, asthma, or bronchitis (prevalence ratio of 1.99, compared with 2019), cardiac arrest and ventricular fibrillation (PR, 1.98), and pneumonia not caused by tuberculosis (PR, 1.91), Dr. Hartnett and associates said.

Prevalence ratios for the early pandemic period were down for most other conditions, with some of the largest decreases seen for influenza (PR, 0.16), otitis media (PR, 0.35), and neoplasm-related encounters (PR, 0.40), they said.

Visits have increased each week since reaching their lowest point during April 12-18, but the number for the most recent full week, May 24-30, which was not included in the analysis, was still 26% lower than the corresponding week in 2019, the CDC team pointed out.

“Some persons could be delaying care for conditions that might result in additional mortality if left untreated,” the investigators noted, and those “who use the ED as a safety net because they lack access to primary care and telemedicine might be disproportionately affected if they avoid seeking care because of concerns about the infection risk in the ED.”

[email protected]

SOURCE: Hartnett KP et al. MMWR. 2020 Jun 3. 69:1-6.

During a 4-week period early in the COVID-19 pandemic, visits to U.S. emergency departments were down by 42%, compared with the corresponding period in 2019, according to a report from the Centers for Disease Control and Prevention.

“The striking decline in ED visits nationwide … suggests that the pandemic has altered the use of the ED by the public,” Kathleen P. Hartnett, PhD, and associates at the CDC said June 3 in the Mortality and Morbidity Weekly Report.

The weekly mean was just over 1.2 million ED visits for the 4 weeks from March 29 to April 25, 2020, compared with the nearly 2.2 million visits per week recorded from March 31 to April 27, 2019 – a drop of 42%, based on an analysis of data from the National Syndromic Surveillance Program.

Despite that drop, ED visits for infectious disease–related reasons, taken as a proportion of all 1.2 ED visits during the early pandemic period, were 3.8 times higher than the comparison period in 2019, the investigators reported.

ED visits also were higher in 2020 for specified and unspecified lower respiratory disease not including influenza, pneumonia, asthma, or bronchitis (prevalence ratio of 1.99, compared with 2019), cardiac arrest and ventricular fibrillation (PR, 1.98), and pneumonia not caused by tuberculosis (PR, 1.91), Dr. Hartnett and associates said.

Prevalence ratios for the early pandemic period were down for most other conditions, with some of the largest decreases seen for influenza (PR, 0.16), otitis media (PR, 0.35), and neoplasm-related encounters (PR, 0.40), they said.

Visits have increased each week since reaching their lowest point during April 12-18, but the number for the most recent full week, May 24-30, which was not included in the analysis, was still 26% lower than the corresponding week in 2019, the CDC team pointed out.

“Some persons could be delaying care for conditions that might result in additional mortality if left untreated,” the investigators noted, and those “who use the ED as a safety net because they lack access to primary care and telemedicine might be disproportionately affected if they avoid seeking care because of concerns about the infection risk in the ED.”

[email protected]

SOURCE: Hartnett KP et al. MMWR. 2020 Jun 3. 69:1-6.

During a 4-week period early in the COVID-19 pandemic, visits to U.S. emergency departments were down by 42%, compared with the corresponding period in 2019, according to a report from the Centers for Disease Control and Prevention.

“The striking decline in ED visits nationwide … suggests that the pandemic has altered the use of the ED by the public,” Kathleen P. Hartnett, PhD, and associates at the CDC said June 3 in the Mortality and Morbidity Weekly Report.

The weekly mean was just over 1.2 million ED visits for the 4 weeks from March 29 to April 25, 2020, compared with the nearly 2.2 million visits per week recorded from March 31 to April 27, 2019 – a drop of 42%, based on an analysis of data from the National Syndromic Surveillance Program.

Despite that drop, ED visits for infectious disease–related reasons, taken as a proportion of all 1.2 ED visits during the early pandemic period, were 3.8 times higher than the comparison period in 2019, the investigators reported.

ED visits also were higher in 2020 for specified and unspecified lower respiratory disease not including influenza, pneumonia, asthma, or bronchitis (prevalence ratio of 1.99, compared with 2019), cardiac arrest and ventricular fibrillation (PR, 1.98), and pneumonia not caused by tuberculosis (PR, 1.91), Dr. Hartnett and associates said.

Prevalence ratios for the early pandemic period were down for most other conditions, with some of the largest decreases seen for influenza (PR, 0.16), otitis media (PR, 0.35), and neoplasm-related encounters (PR, 0.40), they said.

Visits have increased each week since reaching their lowest point during April 12-18, but the number for the most recent full week, May 24-30, which was not included in the analysis, was still 26% lower than the corresponding week in 2019, the CDC team pointed out.

“Some persons could be delaying care for conditions that might result in additional mortality if left untreated,” the investigators noted, and those “who use the ED as a safety net because they lack access to primary care and telemedicine might be disproportionately affected if they avoid seeking care because of concerns about the infection risk in the ED.”

[email protected]

SOURCE: Hartnett KP et al. MMWR. 2020 Jun 3. 69:1-6.

I grew up in a family that was pretty much devoid of physical demonstrations of affection. I certainly felt that my folks loved me, but there was no hugging. I don’t recall ever seeing my parents kiss or touch each other. My dad would occasionally physically tease my mother. For example, I can remember one incident at the dinner table when he was playfully and gently laying a hand on my mother’s arm just as she was raising her fork to her mouth. After about three of these gentle holds, she lifted her water glass and tossed its contents in his face. This was the full extent of physicality in our family.

kate_sept2004/thinkstock

It wasn’t just my parents. I can’t remember aunts or uncles or cousins ever hugging us when we met. Grandmothers of course would request a hug. I never knew either of my grandfathers, but I suspect they would not have been the hugging kind.

I never felt I was missing out on anything, because in the generally WASPish atmosphere of the community in which I grew up I saw very few public displays of affection. But somewhere over time, hugging crept into the American repertoire of expression. This incursion may have been a ripple effect from the flower power, free love hippiedom of the ‘60s and ‘70s. Or it may have been a symptom of globalization as Americans became more familiar with other cultures in which physical expression was more common.

Whatever the reason for the more widespread adoption of hugging in our social vocabulary with my somewhat physically impoverished upbringing, it took me longer than most folks to comfortably include it in my greeting options. Although I may have come to the dance late, I have fully adopted hugging as a way to greet people with whom I have more than a passing acquaintance.

In fact, the ability to comfortably hug former coworkers, old friends I haven’t seen in years, and parents with whom I had shared a particularly troublesome child is what I miss most about the restrictions that have come with the COVID-19 pandemic. Now when I meet folks in the grocery store with whom I share a special affection that magnetic spark still leaps between our eyes, just visible over our face masks, but mentally and physically we take a step back and say to ourselves that this hug shouldn’t happen and it isn’t going to happen. And that makes me sad.

One of the great perks of practicing pediatrics in a small town and then remaining there in retirement is that nearly every week I encounter one or two people with whom I have a long and sometimes emotionally charged relationship. Nurses with whom I sweated over difficult delivery room resuscitations. Parents for whom their anxiety was getting in the way of their ability to parent. Parents and caregivers of complex multiply disabled children who are now adults. Peers who have lost a spouse or a child. I’m sure you have your own list of people who send off that we-need-to-hug spark.

I can envision a day sometime in the relatively near future that I will be able to hug my two grandchildren whom I haven’t hugged even though they live a short 10-minute walk away. But I have trouble imagining when I will again be able to enjoy and be enriched by those special grocery store hugs that I have grown to savor.

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.” Email him at [email protected].

I grew up in a family that was pretty much devoid of physical demonstrations of affection. I certainly felt that my folks loved me, but there was no hugging. I don’t recall ever seeing my parents kiss or touch each other. My dad would occasionally physically tease my mother. For example, I can remember one incident at the dinner table when he was playfully and gently laying a hand on my mother’s arm just as she was raising her fork to her mouth. After about three of these gentle holds, she lifted her water glass and tossed its contents in his face. This was the full extent of physicality in our family.

kate_sept2004/thinkstock

It wasn’t just my parents. I can’t remember aunts or uncles or cousins ever hugging us when we met. Grandmothers of course would request a hug. I never knew either of my grandfathers, but I suspect they would not have been the hugging kind.

I never felt I was missing out on anything, because in the generally WASPish atmosphere of the community in which I grew up I saw very few public displays of affection. But somewhere over time, hugging crept into the American repertoire of expression. This incursion may have been a ripple effect from the flower power, free love hippiedom of the ‘60s and ‘70s. Or it may have been a symptom of globalization as Americans became more familiar with other cultures in which physical expression was more common.

Whatever the reason for the more widespread adoption of hugging in our social vocabulary with my somewhat physically impoverished upbringing, it took me longer than most folks to comfortably include it in my greeting options. Although I may have come to the dance late, I have fully adopted hugging as a way to greet people with whom I have more than a passing acquaintance.

In fact, the ability to comfortably hug former coworkers, old friends I haven’t seen in years, and parents with whom I had shared a particularly troublesome child is what I miss most about the restrictions that have come with the COVID-19 pandemic. Now when I meet folks in the grocery store with whom I share a special affection that magnetic spark still leaps between our eyes, just visible over our face masks, but mentally and physically we take a step back and say to ourselves that this hug shouldn’t happen and it isn’t going to happen. And that makes me sad.

One of the great perks of practicing pediatrics in a small town and then remaining there in retirement is that nearly every week I encounter one or two people with whom I have a long and sometimes emotionally charged relationship. Nurses with whom I sweated over difficult delivery room resuscitations. Parents for whom their anxiety was getting in the way of their ability to parent. Parents and caregivers of complex multiply disabled children who are now adults. Peers who have lost a spouse or a child. I’m sure you have your own list of people who send off that we-need-to-hug spark.

I can envision a day sometime in the relatively near future that I will be able to hug my two grandchildren whom I haven’t hugged even though they live a short 10-minute walk away. But I have trouble imagining when I will again be able to enjoy and be enriched by those special grocery store hugs that I have grown to savor.

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.” Email him at [email protected].

I grew up in a family that was pretty much devoid of physical demonstrations of affection. I certainly felt that my folks loved me, but there was no hugging. I don’t recall ever seeing my parents kiss or touch each other. My dad would occasionally physically tease my mother. For example, I can remember one incident at the dinner table when he was playfully and gently laying a hand on my mother’s arm just as she was raising her fork to her mouth. After about three of these gentle holds, she lifted her water glass and tossed its contents in his face. This was the full extent of physicality in our family.

kate_sept2004/thinkstock

It wasn’t just my parents. I can’t remember aunts or uncles or cousins ever hugging us when we met. Grandmothers of course would request a hug. I never knew either of my grandfathers, but I suspect they would not have been the hugging kind.

I never felt I was missing out on anything, because in the generally WASPish atmosphere of the community in which I grew up I saw very few public displays of affection. But somewhere over time, hugging crept into the American repertoire of expression. This incursion may have been a ripple effect from the flower power, free love hippiedom of the ‘60s and ‘70s. Or it may have been a symptom of globalization as Americans became more familiar with other cultures in which physical expression was more common.

Whatever the reason for the more widespread adoption of hugging in our social vocabulary with my somewhat physically impoverished upbringing, it took me longer than most folks to comfortably include it in my greeting options. Although I may have come to the dance late, I have fully adopted hugging as a way to greet people with whom I have more than a passing acquaintance.

In fact, the ability to comfortably hug former coworkers, old friends I haven’t seen in years, and parents with whom I had shared a particularly troublesome child is what I miss most about the restrictions that have come with the COVID-19 pandemic. Now when I meet folks in the grocery store with whom I share a special affection that magnetic spark still leaps between our eyes, just visible over our face masks, but mentally and physically we take a step back and say to ourselves that this hug shouldn’t happen and it isn’t going to happen. And that makes me sad.

One of the great perks of practicing pediatrics in a small town and then remaining there in retirement is that nearly every week I encounter one or two people with whom I have a long and sometimes emotionally charged relationship. Nurses with whom I sweated over difficult delivery room resuscitations. Parents for whom their anxiety was getting in the way of their ability to parent. Parents and caregivers of complex multiply disabled children who are now adults. Peers who have lost a spouse or a child. I’m sure you have your own list of people who send off that we-need-to-hug spark.

I can envision a day sometime in the relatively near future that I will be able to hug my two grandchildren whom I haven’t hugged even though they live a short 10-minute walk away. But I have trouble imagining when I will again be able to enjoy and be enriched by those special grocery store hugs that I have grown to savor.

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.” Email him at [email protected].

Among patients with COPD, the presence of hypogammaglobulinemia confers a nearly 30% increased risk of hospitalization, results from a pooled analysis of four studies showed.

“Mechanistic studies are still warranted to better elucidate how IgG and other immunoglobulins, in particular IgA, may contribute to the local airway host defense,” researchers led by Fernando Sergio Leitao Filho, MD, PhD, wrote in a study published in Chest (2020 May 18. doi: 10.1016/j.chest.2020.04.058). “Nevertheless, our results raise the possibility that, in select COPD patients, IgG replacement therapy may be effective in reducing the risk of COPD hospitalizations. Given the growing rate of COPD hospitalization in the U.S. and elsewhere, there is a pressing need for a large well-designed trial to test this hypothesis.”

In an effort to evaluate the effect of IgG levels on the cumulative incidence of COPD hospitalizations, Dr. Leitao Filho, of the University of British Columbia, Vancouver, and colleagues drew from 2,259 patients who participated in four different trials: Azithromycin for Prevention of Exacerbations of COPD (MACRO), Simvastatin for the Prevention of Exacerbations in Moderate and Severe COPD (STATCOPE), the Long-Term Oxygen Treatment Trial (LOTT), and COPD Activity: Serotonin Transporter, Cytokines and Depression (CASCADE). The mean baseline age of study participants was 66 years, and 641 (28.4%) had hypogammaglobulinemia, which was defined as having a serum IgG levels of less than 7.0 g/L, while the remainder had normal IgG levels.

The pooled meta-analysis, which is believed to be the largest of its kind, revealed that the presence of hypogammaglobulinemia was associated with an incidence of COPD hospitalizations that was 1.29-fold higher than that observed among participants who had normal IgG levels (P = .01). The incidence was even higher among patients with prior COPD admissions (pooled subdistribution hazard ratio, 1.58; P < .01), yet the risk of COPD admissions was similar between IgG groups in patients with no prior hospitalizations (pooled SHR, 1.15; P = .34). Patients with hypogammaglobulinemia also showed significantly higher rates of COPD hospitalizations per person-year, compared with their counterparts who had normal IgG levels (0.48 vs. 0.29, respectively; P < .001.)

The authors acknowledged certain limitations of the study, including the fact that they measured serum IgG levels only at baseline “when participants were clinically stable; thus, the variability of IgG levels in a given individual over time and during the course of an AECOPD [severe acute exacerbation of COPD] is uncertain. Secondly, clinical data on corticosteroid use (formulations, dose, and length of use) were not readily available. However, systemic steroid use (one or more courses due to AECOPD prior to study entry) was accounted for in our analyses.”

The MACRO, STATCOPE, LOTT trials, and the CASCADE cohort were supported by the National Heart, Lung, and Blood Institute; National Institutes of Health; and Department of Health & Human Services. The current study was funded by the Canadian Institutes of Health Research and BC Lung Association. The authors reported having no relevant disclosures.

SOURCE: Leitao Filho SF et al. Chest. 2020 May 18. doi: 10.1016/j.chest.2020.04.058.

Among patients with COPD, the presence of hypogammaglobulinemia confers a nearly 30% increased risk of hospitalization, results from a pooled analysis of four studies showed.

“Mechanistic studies are still warranted to better elucidate how IgG and other immunoglobulins, in particular IgA, may contribute to the local airway host defense,” researchers led by Fernando Sergio Leitao Filho, MD, PhD, wrote in a study published in Chest (2020 May 18. doi: 10.1016/j.chest.2020.04.058). “Nevertheless, our results raise the possibility that, in select COPD patients, IgG replacement therapy may be effective in reducing the risk of COPD hospitalizations. Given the growing rate of COPD hospitalization in the U.S. and elsewhere, there is a pressing need for a large well-designed trial to test this hypothesis.”

In an effort to evaluate the effect of IgG levels on the cumulative incidence of COPD hospitalizations, Dr. Leitao Filho, of the University of British Columbia, Vancouver, and colleagues drew from 2,259 patients who participated in four different trials: Azithromycin for Prevention of Exacerbations of COPD (MACRO), Simvastatin for the Prevention of Exacerbations in Moderate and Severe COPD (STATCOPE), the Long-Term Oxygen Treatment Trial (LOTT), and COPD Activity: Serotonin Transporter, Cytokines and Depression (CASCADE). The mean baseline age of study participants was 66 years, and 641 (28.4%) had hypogammaglobulinemia, which was defined as having a serum IgG levels of less than 7.0 g/L, while the remainder had normal IgG levels.

The pooled meta-analysis, which is believed to be the largest of its kind, revealed that the presence of hypogammaglobulinemia was associated with an incidence of COPD hospitalizations that was 1.29-fold higher than that observed among participants who had normal IgG levels (P = .01). The incidence was even higher among patients with prior COPD admissions (pooled subdistribution hazard ratio, 1.58; P < .01), yet the risk of COPD admissions was similar between IgG groups in patients with no prior hospitalizations (pooled SHR, 1.15; P = .34). Patients with hypogammaglobulinemia also showed significantly higher rates of COPD hospitalizations per person-year, compared with their counterparts who had normal IgG levels (0.48 vs. 0.29, respectively; P < .001.)

The authors acknowledged certain limitations of the study, including the fact that they measured serum IgG levels only at baseline “when participants were clinically stable; thus, the variability of IgG levels in a given individual over time and during the course of an AECOPD [severe acute exacerbation of COPD] is uncertain. Secondly, clinical data on corticosteroid use (formulations, dose, and length of use) were not readily available. However, systemic steroid use (one or more courses due to AECOPD prior to study entry) was accounted for in our analyses.”

The MACRO, STATCOPE, LOTT trials, and the CASCADE cohort were supported by the National Heart, Lung, and Blood Institute; National Institutes of Health; and Department of Health & Human Services. The current study was funded by the Canadian Institutes of Health Research and BC Lung Association. The authors reported having no relevant disclosures.

SOURCE: Leitao Filho SF et al. Chest. 2020 May 18. doi: 10.1016/j.chest.2020.04.058.

Among patients with COPD, the presence of hypogammaglobulinemia confers a nearly 30% increased risk of hospitalization, results from a pooled analysis of four studies showed.

“Mechanistic studies are still warranted to better elucidate how IgG and other immunoglobulins, in particular IgA, may contribute to the local airway host defense,” researchers led by Fernando Sergio Leitao Filho, MD, PhD, wrote in a study published in Chest (2020 May 18. doi: 10.1016/j.chest.2020.04.058). “Nevertheless, our results raise the possibility that, in select COPD patients, IgG replacement therapy may be effective in reducing the risk of COPD hospitalizations. Given the growing rate of COPD hospitalization in the U.S. and elsewhere, there is a pressing need for a large well-designed trial to test this hypothesis.”

In an effort to evaluate the effect of IgG levels on the cumulative incidence of COPD hospitalizations, Dr. Leitao Filho, of the University of British Columbia, Vancouver, and colleagues drew from 2,259 patients who participated in four different trials: Azithromycin for Prevention of Exacerbations of COPD (MACRO), Simvastatin for the Prevention of Exacerbations in Moderate and Severe COPD (STATCOPE), the Long-Term Oxygen Treatment Trial (LOTT), and COPD Activity: Serotonin Transporter, Cytokines and Depression (CASCADE). The mean baseline age of study participants was 66 years, and 641 (28.4%) had hypogammaglobulinemia, which was defined as having a serum IgG levels of less than 7.0 g/L, while the remainder had normal IgG levels.

The pooled meta-analysis, which is believed to be the largest of its kind, revealed that the presence of hypogammaglobulinemia was associated with an incidence of COPD hospitalizations that was 1.29-fold higher than that observed among participants who had normal IgG levels (P = .01). The incidence was even higher among patients with prior COPD admissions (pooled subdistribution hazard ratio, 1.58; P < .01), yet the risk of COPD admissions was similar between IgG groups in patients with no prior hospitalizations (pooled SHR, 1.15; P = .34). Patients with hypogammaglobulinemia also showed significantly higher rates of COPD hospitalizations per person-year, compared with their counterparts who had normal IgG levels (0.48 vs. 0.29, respectively; P < .001.)

The authors acknowledged certain limitations of the study, including the fact that they measured serum IgG levels only at baseline “when participants were clinically stable; thus, the variability of IgG levels in a given individual over time and during the course of an AECOPD [severe acute exacerbation of COPD] is uncertain. Secondly, clinical data on corticosteroid use (formulations, dose, and length of use) were not readily available. However, systemic steroid use (one or more courses due to AECOPD prior to study entry) was accounted for in our analyses.”

The MACRO, STATCOPE, LOTT trials, and the CASCADE cohort were supported by the National Heart, Lung, and Blood Institute; National Institutes of Health; and Department of Health & Human Services. The current study was funded by the Canadian Institutes of Health Research and BC Lung Association. The authors reported having no relevant disclosures.

SOURCE: Leitao Filho SF et al. Chest. 2020 May 18. doi: 10.1016/j.chest.2020.04.058.

The Food and Drug Administration issued an emergency use authorization for use of the Impella RP heart pump system in COVID-19 patients with right heart failure or decompensation, Abiomed announced June 1.

“Based on extrapolation of data from the approved indication and reported clinical experience, FDA has concluded that the Impella RP may be effective at providing temporary right ventricular support for the treatment of acute right heart failure or decompensation caused by COVID-19 complications, including PE [pulmonary embolism],” the letter noted.

It cited, for example, use of the temporary heart pump in a 59-year-old woman suffering from COVID-19 who went into right ventricular failure and became hypotensive after an acute PE was removed. After placement of the device, the patient experienced a “dramatic and immediate” improvement in arterial pressure and the device was removed on the fifth day, according to Amir Kaki, MD, and Ted Schreiber, MD, of Ascension St. John Hospital, Detroit, whose review of the case has been posted online.

“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic,” Dr. Kaki said in the letter. “As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be lifesaving.”

Other data cited in support of the Impella RP emergency use authorization (EUA) include a 2019 series of hemodynamically unstable patients with PE in Japan and a 2017 case report of a 47-year-old man with right ventricular failure, profound shock, and a massive PE.

The FDA granted premarket approval of the Impella RP system in 2017 to provide temporary right ventricular support for up to 14 days in patients with a body surface area of at least 1.5 m² who develop acute right heart failure or decompensation following left ventricular assist device implantation, MI, heart transplant, or open-heart surgery.

The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m2 for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including PE.

The Impella RP is authorized only for emergency use under the EUA and only for the duration of the circumstances justifying use of EUAs, the letter noted.

Last year, concerns were raised about off-indication use after interim results from a postapproval study suggested a higher risk for death than seen in premarket studies treated with the temporary heart pump.

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

The Food and Drug Administration issued an emergency use authorization for use of the Impella RP heart pump system in COVID-19 patients with right heart failure or decompensation, Abiomed announced June 1.

“Based on extrapolation of data from the approved indication and reported clinical experience, FDA has concluded that the Impella RP may be effective at providing temporary right ventricular support for the treatment of acute right heart failure or decompensation caused by COVID-19 complications, including PE [pulmonary embolism],” the letter noted.

It cited, for example, use of the temporary heart pump in a 59-year-old woman suffering from COVID-19 who went into right ventricular failure and became hypotensive after an acute PE was removed. After placement of the device, the patient experienced a “dramatic and immediate” improvement in arterial pressure and the device was removed on the fifth day, according to Amir Kaki, MD, and Ted Schreiber, MD, of Ascension St. John Hospital, Detroit, whose review of the case has been posted online.

“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic,” Dr. Kaki said in the letter. “As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be lifesaving.”

Other data cited in support of the Impella RP emergency use authorization (EUA) include a 2019 series of hemodynamically unstable patients with PE in Japan and a 2017 case report of a 47-year-old man with right ventricular failure, profound shock, and a massive PE.

The FDA granted premarket approval of the Impella RP system in 2017 to provide temporary right ventricular support for up to 14 days in patients with a body surface area of at least 1.5 m² who develop acute right heart failure or decompensation following left ventricular assist device implantation, MI, heart transplant, or open-heart surgery.

The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m2 for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including PE.

The Impella RP is authorized only for emergency use under the EUA and only for the duration of the circumstances justifying use of EUAs, the letter noted.

Last year, concerns were raised about off-indication use after interim results from a postapproval study suggested a higher risk for death than seen in premarket studies treated with the temporary heart pump.

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

The Food and Drug Administration issued an emergency use authorization for use of the Impella RP heart pump system in COVID-19 patients with right heart failure or decompensation, Abiomed announced June 1.

“Based on extrapolation of data from the approved indication and reported clinical experience, FDA has concluded that the Impella RP may be effective at providing temporary right ventricular support for the treatment of acute right heart failure or decompensation caused by COVID-19 complications, including PE [pulmonary embolism],” the letter noted.

It cited, for example, use of the temporary heart pump in a 59-year-old woman suffering from COVID-19 who went into right ventricular failure and became hypotensive after an acute PE was removed. After placement of the device, the patient experienced a “dramatic and immediate” improvement in arterial pressure and the device was removed on the fifth day, according to Amir Kaki, MD, and Ted Schreiber, MD, of Ascension St. John Hospital, Detroit, whose review of the case has been posted online.

“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic,” Dr. Kaki said in the letter. “As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be lifesaving.”

Other data cited in support of the Impella RP emergency use authorization (EUA) include a 2019 series of hemodynamically unstable patients with PE in Japan and a 2017 case report of a 47-year-old man with right ventricular failure, profound shock, and a massive PE.

The FDA granted premarket approval of the Impella RP system in 2017 to provide temporary right ventricular support for up to 14 days in patients with a body surface area of at least 1.5 m² who develop acute right heart failure or decompensation following left ventricular assist device implantation, MI, heart transplant, or open-heart surgery.

The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m2 for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including PE.

The Impella RP is authorized only for emergency use under the EUA and only for the duration of the circumstances justifying use of EUAs, the letter noted.

Last year, concerns were raised about off-indication use after interim results from a postapproval study suggested a higher risk for death than seen in premarket studies treated with the temporary heart pump.

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