MDedge Neurology

Long-term treatment with ataluren delays loss of ambulation and may delay decline in pulmonary function in patients with nonsense mutation Duchenne muscular dystrophy (nmDMD), according to study results presented at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year. Because so few patients in the study reached one of the negative pulmonary endpoints, longer follow-up will be needed to assess more conclusively the effect of ataluren on pulmonary function, said Francesco Bibbiani, MD, vice president of clinical development at PTC Therapeutics.

DMD is a rare and fatal neuromuscular disorder that causes progressive muscle weakness. Between 10% and 15% of patients with DMD have a nonsense mutation in the DMD gene. This mutation creates a premature stop codon that prevents the translation of a full-length dystrophin protein. Ataluren is designed to promote readthrough of this premature stop codon, thus enabling the production of a full-length dystrophin protein. An oral formulation of the drug has been approved in several European and South American countries.
 

Comparing treatment and standard of care

Study 019 was a phase 3, multicenter, open-label, long-term safety study of ataluren that enrolled international patients with nmDMD, most of whom had participated previously in a trial of ataluren. Dr. Bibbiani and colleagues conducted a post hoc analysis of Study 019 data to determine whether patients with nmDMD who received ataluren and standard of care for as long as 240 weeks had a different time to loss of ambulation and to decline of pulmonary function, compared with patients who received standard of care alone. Patients who were eligible to participate in Study 019 were male, had nmDMD, and had completed the blinded study drug treatment in a previous PTC-sponsored study. Treatment consisted of two 10-mg/kg doses and one 20-mg/kg dose of ataluren per day.

Dr. Bibbiani and colleagues used participants in the Cooperative International Neuromuscular Research Group Duchenne Natural History Study (CINRG DNHS) as a control group. CINRG DNHS was a prospective, longitudinal study of patients with DMD who received standard of care at 20 centers worldwide from 2006 to 2016. Dr. Bibbiani and colleagues used propensity-score matching to pair participants in this study with participants in Study 019. They matched patients with respect to age at onset of first symptoms, age at initiation of corticosteroid use, duration of deflazacort use, and duration of use of other corticosteroids. These factors are established predictors of disease progression in DMD.

Patients were eligible for inclusion in the post hoc analysis if they had available data for age, loss of ambulation, and the covariates selected for matching. Of 94 Study 019 participants, 60 were eligible for propensity-score matching with participants in CINRG DNHS. Forty-five nonambulatory patients were eligible for matching in the analysis of age at the decline in pulmonary function because data for age at loss of ambulation and for the three pulmonary endpoints measured were available for them. Thus, comparable population sizes were available for each analysis.
 

Treatment delayed disease milestones

Kaplan–Meier analysis indicated that the median age at various disease milestones was higher among patients who received ataluren and standard of care, compared with those who received standard of care alone. The median age at loss of ambulation was 15.5 years for Study 019 participants and 13.3 years for CINRG DNHS patients. The median age at predicted forced vital capacity (FVC) of less than 60% was 18.1 years for Study 019 participants and 15.8 years for CINRG DNHS participants. The median age at predicted FVC of less than 50% was 19.1 years for Study 019 participants and 17.9 years for CINRG DNHS participants. Finally, the median age at FVC of less than 1 L was not calculable for Study 019 participants and 23.8 years for CINRG DNHS participants.

The Study 019 and CINRG DNHS study groups are sponsored by PTC Therapeutics, which developed ataluren. Dr. Bibbiani is an employee of PTC Therapeutics.

egreb@mdedge.com

SOURCE: McDonald C, et al. CNS-ICNA 2020. Abstract PL69.

Long-term treatment with ataluren delays loss of ambulation and may delay decline in pulmonary function in patients with nonsense mutation Duchenne muscular dystrophy (nmDMD), according to study results presented at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year. Because so few patients in the study reached one of the negative pulmonary endpoints, longer follow-up will be needed to assess more conclusively the effect of ataluren on pulmonary function, said Francesco Bibbiani, MD, vice president of clinical development at PTC Therapeutics.

DMD is a rare and fatal neuromuscular disorder that causes progressive muscle weakness. Between 10% and 15% of patients with DMD have a nonsense mutation in the DMD gene. This mutation creates a premature stop codon that prevents the translation of a full-length dystrophin protein. Ataluren is designed to promote readthrough of this premature stop codon, thus enabling the production of a full-length dystrophin protein. An oral formulation of the drug has been approved in several European and South American countries.
 

Comparing treatment and standard of care

Study 019 was a phase 3, multicenter, open-label, long-term safety study of ataluren that enrolled international patients with nmDMD, most of whom had participated previously in a trial of ataluren. Dr. Bibbiani and colleagues conducted a post hoc analysis of Study 019 data to determine whether patients with nmDMD who received ataluren and standard of care for as long as 240 weeks had a different time to loss of ambulation and to decline of pulmonary function, compared with patients who received standard of care alone. Patients who were eligible to participate in Study 019 were male, had nmDMD, and had completed the blinded study drug treatment in a previous PTC-sponsored study. Treatment consisted of two 10-mg/kg doses and one 20-mg/kg dose of ataluren per day.

Dr. Bibbiani and colleagues used participants in the Cooperative International Neuromuscular Research Group Duchenne Natural History Study (CINRG DNHS) as a control group. CINRG DNHS was a prospective, longitudinal study of patients with DMD who received standard of care at 20 centers worldwide from 2006 to 2016. Dr. Bibbiani and colleagues used propensity-score matching to pair participants in this study with participants in Study 019. They matched patients with respect to age at onset of first symptoms, age at initiation of corticosteroid use, duration of deflazacort use, and duration of use of other corticosteroids. These factors are established predictors of disease progression in DMD.

Patients were eligible for inclusion in the post hoc analysis if they had available data for age, loss of ambulation, and the covariates selected for matching. Of 94 Study 019 participants, 60 were eligible for propensity-score matching with participants in CINRG DNHS. Forty-five nonambulatory patients were eligible for matching in the analysis of age at the decline in pulmonary function because data for age at loss of ambulation and for the three pulmonary endpoints measured were available for them. Thus, comparable population sizes were available for each analysis.
 

Treatment delayed disease milestones

Kaplan–Meier analysis indicated that the median age at various disease milestones was higher among patients who received ataluren and standard of care, compared with those who received standard of care alone. The median age at loss of ambulation was 15.5 years for Study 019 participants and 13.3 years for CINRG DNHS patients. The median age at predicted forced vital capacity (FVC) of less than 60% was 18.1 years for Study 019 participants and 15.8 years for CINRG DNHS participants. The median age at predicted FVC of less than 50% was 19.1 years for Study 019 participants and 17.9 years for CINRG DNHS participants. Finally, the median age at FVC of less than 1 L was not calculable for Study 019 participants and 23.8 years for CINRG DNHS participants.

The Study 019 and CINRG DNHS study groups are sponsored by PTC Therapeutics, which developed ataluren. Dr. Bibbiani is an employee of PTC Therapeutics.

egreb@mdedge.com

SOURCE: McDonald C, et al. CNS-ICNA 2020. Abstract PL69.

Long-term treatment with ataluren delays loss of ambulation and may delay decline in pulmonary function in patients with nonsense mutation Duchenne muscular dystrophy (nmDMD), according to study results presented at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year. Because so few patients in the study reached one of the negative pulmonary endpoints, longer follow-up will be needed to assess more conclusively the effect of ataluren on pulmonary function, said Francesco Bibbiani, MD, vice president of clinical development at PTC Therapeutics.

DMD is a rare and fatal neuromuscular disorder that causes progressive muscle weakness. Between 10% and 15% of patients with DMD have a nonsense mutation in the DMD gene. This mutation creates a premature stop codon that prevents the translation of a full-length dystrophin protein. Ataluren is designed to promote readthrough of this premature stop codon, thus enabling the production of a full-length dystrophin protein. An oral formulation of the drug has been approved in several European and South American countries.
 

Comparing treatment and standard of care

Study 019 was a phase 3, multicenter, open-label, long-term safety study of ataluren that enrolled international patients with nmDMD, most of whom had participated previously in a trial of ataluren. Dr. Bibbiani and colleagues conducted a post hoc analysis of Study 019 data to determine whether patients with nmDMD who received ataluren and standard of care for as long as 240 weeks had a different time to loss of ambulation and to decline of pulmonary function, compared with patients who received standard of care alone. Patients who were eligible to participate in Study 019 were male, had nmDMD, and had completed the blinded study drug treatment in a previous PTC-sponsored study. Treatment consisted of two 10-mg/kg doses and one 20-mg/kg dose of ataluren per day.

Dr. Bibbiani and colleagues used participants in the Cooperative International Neuromuscular Research Group Duchenne Natural History Study (CINRG DNHS) as a control group. CINRG DNHS was a prospective, longitudinal study of patients with DMD who received standard of care at 20 centers worldwide from 2006 to 2016. Dr. Bibbiani and colleagues used propensity-score matching to pair participants in this study with participants in Study 019. They matched patients with respect to age at onset of first symptoms, age at initiation of corticosteroid use, duration of deflazacort use, and duration of use of other corticosteroids. These factors are established predictors of disease progression in DMD.

Patients were eligible for inclusion in the post hoc analysis if they had available data for age, loss of ambulation, and the covariates selected for matching. Of 94 Study 019 participants, 60 were eligible for propensity-score matching with participants in CINRG DNHS. Forty-five nonambulatory patients were eligible for matching in the analysis of age at the decline in pulmonary function because data for age at loss of ambulation and for the three pulmonary endpoints measured were available for them. Thus, comparable population sizes were available for each analysis.
 

Treatment delayed disease milestones

Kaplan–Meier analysis indicated that the median age at various disease milestones was higher among patients who received ataluren and standard of care, compared with those who received standard of care alone. The median age at loss of ambulation was 15.5 years for Study 019 participants and 13.3 years for CINRG DNHS patients. The median age at predicted forced vital capacity (FVC) of less than 60% was 18.1 years for Study 019 participants and 15.8 years for CINRG DNHS participants. The median age at predicted FVC of less than 50% was 19.1 years for Study 019 participants and 17.9 years for CINRG DNHS participants. Finally, the median age at FVC of less than 1 L was not calculable for Study 019 participants and 23.8 years for CINRG DNHS participants.

The Study 019 and CINRG DNHS study groups are sponsored by PTC Therapeutics, which developed ataluren. Dr. Bibbiani is an employee of PTC Therapeutics.

egreb@mdedge.com

SOURCE: McDonald C, et al. CNS-ICNA 2020. Abstract PL69.

Among patients with pediatric-onset relapsing-remitting multiple sclerosis (MS), newer disease-modifying therapies (DMTs) reduce clinical and radiological disease activity more effectively than older injectable therapies. Nevertheless, all DMTs reduce children’s annualized relapse rate (ARR), according to results presented at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year.

“Our study adds weight to the argument for an imminent shift in clinical practice toward the use of newer, more efficacious DMTs in the first instance,” said Omar Abdel-Mannan, MD, of Great Ormond Street Hospital in London. MRI activity continues among patients treated with DMTs, and the number of relapses is highest in the period following diagnosis. But because the effect of treatment on brain atrophy is greatest in the initial period of disease, “this time period may represent a critical therapeutic window for the use of highly effective therapies,” said Dr. Abdel-Mannan.
 

An examination of medical records

MS is much less prevalent among children than among adults. Compared with adults with MS, children with MS have a higher relapse rate and slower accumulation of disability. The individual response to DMTs is variable, said Dr. Abdel-Mannan. Furthermore, current standards of care for pediatric MS vary by center and are based on adult protocols.

Dr. Abdel-Mannan and colleagues conducted a retrospective study to evaluate the real-world effectiveness of the newer oral and infusion DMTs, compared with the older injectable DMTs, in children with relapsing-remitting MS. They examined data from seven tertiary pediatric neurology centers in the United Kingdom and identified patients under age 18 years with relapsing-remitting MS who were treated with DMTs between 2012 and 2018. The investigators reviewed clinical and paraclinical data retrospectively using electronic medical records. They compared patients’ ARR, new radiological activity, and Expanded Disability Status Scale score pretreatment and on treatment.

The researchers included 103 patients in their analysis. The population’s median age was 14 years. The ratio of girls to boys was approximately 3:1. Whites and other races/ethnicities accounted for approximately equal groups of patients. About one-third of patients presented with a clinically isolated syndrome (CIS) in the form of transverse myelitis or optic neuritis. Two-thirds presented with other CIS phenotypes. Almost all children had an abnormal MRI at onset.
 

Most patients initiated injectable DMTs

Of the 103 patients, 89 started treatment with an injectable (e.g., glatiramer or interferon) or an older DMT. Fourteen patients began treatment with a newer DMT (e.g., dimethyl fumarate, fingolimod, natalizumab, and alemtuzumab). Three of the 89 patients on an injectable DMT switched to another injectable DMT, and two of these patients later escalated to a newer DMT. Thirty-five of the 89 patients who initiated an injectable DMT were escalated immediately to a newer DMT. One of these patients later switched to another newer DMT. Two of the 14 patients who started on a newer DMT as their first drug switched to another newer DMT.

The investigators observed a reduction in ARR for all DMTs used during the study period. Nevertheless, a significant number of patients receiving injectable DMTs continued to relapse on treatment. Almost all patients receiving newer DMTs, however, had a reduction in relapses. When Dr. Abdel-Mannan and colleagues performed Kaplan–Meier survival analysis, they found that patients receiving newer DMTs had a longer time to first relapse and a longer time to switch treatment over 2 years, compared with patients receiving injectable DMTs. In addition, patients receiving newer DMTs had a longer time to develop new radiological activity, compared with patients receiving injectables. The analysis also indicated that the proportion of patients with new radiological activity was higher than the proportion who had clinical relapses and an Expanded Disability Status Scale score increase of more than 1 point over 2 years.

In all, 55 of the children receiving injectable DMTs and 18 of the patients receiving newer DMTs had side effects. The most commonly reported side effects were flulike symptoms and injection-site reactions. Five patients discontinued or switched their DMTs because of side effects. “Reassuringly, no pediatric-specific side effects were reported,” said Dr. Abdel-Mannan. The newer DMTs had similar short-term safety, tolerability, and side-effect profiles in these children as in adult patients.

The study was conducted on behalf of the UK Childhood Inflammatory Demyelination Network. Dr. Abdel-Mannan had no relevant disclosures.

egreb@mdedge.com

SOURCE: Abdel-Mannan O et al. CNS-ICNA 2020, Abstract PL10.

Among patients with pediatric-onset relapsing-remitting multiple sclerosis (MS), newer disease-modifying therapies (DMTs) reduce clinical and radiological disease activity more effectively than older injectable therapies. Nevertheless, all DMTs reduce children’s annualized relapse rate (ARR), according to results presented at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year.

“Our study adds weight to the argument for an imminent shift in clinical practice toward the use of newer, more efficacious DMTs in the first instance,” said Omar Abdel-Mannan, MD, of Great Ormond Street Hospital in London. MRI activity continues among patients treated with DMTs, and the number of relapses is highest in the period following diagnosis. But because the effect of treatment on brain atrophy is greatest in the initial period of disease, “this time period may represent a critical therapeutic window for the use of highly effective therapies,” said Dr. Abdel-Mannan.
 

An examination of medical records

MS is much less prevalent among children than among adults. Compared with adults with MS, children with MS have a higher relapse rate and slower accumulation of disability. The individual response to DMTs is variable, said Dr. Abdel-Mannan. Furthermore, current standards of care for pediatric MS vary by center and are based on adult protocols.

Dr. Abdel-Mannan and colleagues conducted a retrospective study to evaluate the real-world effectiveness of the newer oral and infusion DMTs, compared with the older injectable DMTs, in children with relapsing-remitting MS. They examined data from seven tertiary pediatric neurology centers in the United Kingdom and identified patients under age 18 years with relapsing-remitting MS who were treated with DMTs between 2012 and 2018. The investigators reviewed clinical and paraclinical data retrospectively using electronic medical records. They compared patients’ ARR, new radiological activity, and Expanded Disability Status Scale score pretreatment and on treatment.

The researchers included 103 patients in their analysis. The population’s median age was 14 years. The ratio of girls to boys was approximately 3:1. Whites and other races/ethnicities accounted for approximately equal groups of patients. About one-third of patients presented with a clinically isolated syndrome (CIS) in the form of transverse myelitis or optic neuritis. Two-thirds presented with other CIS phenotypes. Almost all children had an abnormal MRI at onset.
 

Most patients initiated injectable DMTs

Of the 103 patients, 89 started treatment with an injectable (e.g., glatiramer or interferon) or an older DMT. Fourteen patients began treatment with a newer DMT (e.g., dimethyl fumarate, fingolimod, natalizumab, and alemtuzumab). Three of the 89 patients on an injectable DMT switched to another injectable DMT, and two of these patients later escalated to a newer DMT. Thirty-five of the 89 patients who initiated an injectable DMT were escalated immediately to a newer DMT. One of these patients later switched to another newer DMT. Two of the 14 patients who started on a newer DMT as their first drug switched to another newer DMT.

The investigators observed a reduction in ARR for all DMTs used during the study period. Nevertheless, a significant number of patients receiving injectable DMTs continued to relapse on treatment. Almost all patients receiving newer DMTs, however, had a reduction in relapses. When Dr. Abdel-Mannan and colleagues performed Kaplan–Meier survival analysis, they found that patients receiving newer DMTs had a longer time to first relapse and a longer time to switch treatment over 2 years, compared with patients receiving injectable DMTs. In addition, patients receiving newer DMTs had a longer time to develop new radiological activity, compared with patients receiving injectables. The analysis also indicated that the proportion of patients with new radiological activity was higher than the proportion who had clinical relapses and an Expanded Disability Status Scale score increase of more than 1 point over 2 years.

In all, 55 of the children receiving injectable DMTs and 18 of the patients receiving newer DMTs had side effects. The most commonly reported side effects were flulike symptoms and injection-site reactions. Five patients discontinued or switched their DMTs because of side effects. “Reassuringly, no pediatric-specific side effects were reported,” said Dr. Abdel-Mannan. The newer DMTs had similar short-term safety, tolerability, and side-effect profiles in these children as in adult patients.

The study was conducted on behalf of the UK Childhood Inflammatory Demyelination Network. Dr. Abdel-Mannan had no relevant disclosures.

egreb@mdedge.com

SOURCE: Abdel-Mannan O et al. CNS-ICNA 2020, Abstract PL10.

Among patients with pediatric-onset relapsing-remitting multiple sclerosis (MS), newer disease-modifying therapies (DMTs) reduce clinical and radiological disease activity more effectively than older injectable therapies. Nevertheless, all DMTs reduce children’s annualized relapse rate (ARR), according to results presented at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year.

“Our study adds weight to the argument for an imminent shift in clinical practice toward the use of newer, more efficacious DMTs in the first instance,” said Omar Abdel-Mannan, MD, of Great Ormond Street Hospital in London. MRI activity continues among patients treated with DMTs, and the number of relapses is highest in the period following diagnosis. But because the effect of treatment on brain atrophy is greatest in the initial period of disease, “this time period may represent a critical therapeutic window for the use of highly effective therapies,” said Dr. Abdel-Mannan.
 

An examination of medical records

MS is much less prevalent among children than among adults. Compared with adults with MS, children with MS have a higher relapse rate and slower accumulation of disability. The individual response to DMTs is variable, said Dr. Abdel-Mannan. Furthermore, current standards of care for pediatric MS vary by center and are based on adult protocols.

Dr. Abdel-Mannan and colleagues conducted a retrospective study to evaluate the real-world effectiveness of the newer oral and infusion DMTs, compared with the older injectable DMTs, in children with relapsing-remitting MS. They examined data from seven tertiary pediatric neurology centers in the United Kingdom and identified patients under age 18 years with relapsing-remitting MS who were treated with DMTs between 2012 and 2018. The investigators reviewed clinical and paraclinical data retrospectively using electronic medical records. They compared patients’ ARR, new radiological activity, and Expanded Disability Status Scale score pretreatment and on treatment.

The researchers included 103 patients in their analysis. The population’s median age was 14 years. The ratio of girls to boys was approximately 3:1. Whites and other races/ethnicities accounted for approximately equal groups of patients. About one-third of patients presented with a clinically isolated syndrome (CIS) in the form of transverse myelitis or optic neuritis. Two-thirds presented with other CIS phenotypes. Almost all children had an abnormal MRI at onset.
 

Most patients initiated injectable DMTs

Of the 103 patients, 89 started treatment with an injectable (e.g., glatiramer or interferon) or an older DMT. Fourteen patients began treatment with a newer DMT (e.g., dimethyl fumarate, fingolimod, natalizumab, and alemtuzumab). Three of the 89 patients on an injectable DMT switched to another injectable DMT, and two of these patients later escalated to a newer DMT. Thirty-five of the 89 patients who initiated an injectable DMT were escalated immediately to a newer DMT. One of these patients later switched to another newer DMT. Two of the 14 patients who started on a newer DMT as their first drug switched to another newer DMT.

The investigators observed a reduction in ARR for all DMTs used during the study period. Nevertheless, a significant number of patients receiving injectable DMTs continued to relapse on treatment. Almost all patients receiving newer DMTs, however, had a reduction in relapses. When Dr. Abdel-Mannan and colleagues performed Kaplan–Meier survival analysis, they found that patients receiving newer DMTs had a longer time to first relapse and a longer time to switch treatment over 2 years, compared with patients receiving injectable DMTs. In addition, patients receiving newer DMTs had a longer time to develop new radiological activity, compared with patients receiving injectables. The analysis also indicated that the proportion of patients with new radiological activity was higher than the proportion who had clinical relapses and an Expanded Disability Status Scale score increase of more than 1 point over 2 years.

In all, 55 of the children receiving injectable DMTs and 18 of the patients receiving newer DMTs had side effects. The most commonly reported side effects were flulike symptoms and injection-site reactions. Five patients discontinued or switched their DMTs because of side effects. “Reassuringly, no pediatric-specific side effects were reported,” said Dr. Abdel-Mannan. The newer DMTs had similar short-term safety, tolerability, and side-effect profiles in these children as in adult patients.

The study was conducted on behalf of the UK Childhood Inflammatory Demyelination Network. Dr. Abdel-Mannan had no relevant disclosures.

egreb@mdedge.com

SOURCE: Abdel-Mannan O et al. CNS-ICNA 2020, Abstract PL10.

Maintaining antiseizure medication in infants who have had acute symptomatic neonatal seizures has been standard practice, but a prospective, observational, comparative effectiveness study calls that practice into question, providing evidence that discontinuing therapy at discharge poses no harm to children and has no effect on the development of epilepsies.

“The balance of evidence supports discontinuing antiseizure medication after resolution of acute symptomatic neonatal seizures and before discharge home from the neonatal seizure admission,” said Hannah C. Glass, MDCM, MAS, of the University of California, San Francisco, Benioff Children’s Hospital, co-principal investigator, who presented results of the study at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year. Renee Shellhaas, MD, MS, clinical associate professor of pediatrics at C.S. Mott Children’s Hospital, University of Michigan, was the other co-principal investigator.

“Although other, smaller studies have suggested it is safe to discontinue antiseizure medication after resolution of acute symptomatic seizures, the practice of early discontinuation has been very variable and depends largely on individual provider preference,” Dr. Glass said in an interview. “In our study, two-thirds of newborns with acute symptomatic seizures were maintained on antiseizure medication at the time of hospital discharge. Thus, a change to early medication discontinuation represents a major shift.” 

The study evaluated 270 infants at nine centers enrolled in the Neonatal Seizure Registry and born from July 2015 through March 2018. Inclusion criteria were acute symptomatic seizures that occurred at up to 44 weeks postmenstrual age. In this cohort, 36% of patients had antiseizure medication discontinued after a median of 6 days; the remainder stayed on antiseizure medication after discharge at a median of 4 months.

The patients were followed for 2 years. The primary outcome was functional development measured by the Warner Initial Development Evaluation of Adaptive and Functional Skills (WIDEA-FS) assessment. The secondary outcome was epilepsy defined by International League Against Epilepsy (ILAE) criteria. Follow-up consisted of phone calls and chart reviews at 12, 18, and 24 months.

“The primary outcome, functional development, was not significantly different between those children who were maintained on antiseizure medication as compared with those who were discontinued,” Dr. Glass said.

After propensity adjustment, the discontinued ASM group had an estimated WIDEA-FS score 4 points higher on average, she said. “The confidence intervals met our a priori noninferiority limit, indicating no harm to neurodevelopment for discontinuing antiseizure medication before discharge home from the neonatal seizure admission,” Dr. Glass noted.

The study also found that 13% of all participants developed epilepsy at a median of 8 months. “There was no significant difference in the frequency or timing of epilepsy between the two groups,” she said.

“We conclude there is no clear rationale for antiseizure medication maintenance,” Dr. Glass said. “There is no benefit to neurodevelopment, it prolongs the exposure to potentially harmful antiseizure medications, it does not significantly delay the onset of epilepsy, and the earliest-onset epilepsies occur in spite of antiseizure medication.”

The Patient-Centered Outcomes Research Institute (PCORI) and Pediatric Epilepsy Research Foundation funded the study. Dr. Glass has no other financial relationships to disclose.

SOURCE: Glass HC et al. CNS-ICNA 2020. Presentation PL58.

Maintaining antiseizure medication in infants who have had acute symptomatic neonatal seizures has been standard practice, but a prospective, observational, comparative effectiveness study calls that practice into question, providing evidence that discontinuing therapy at discharge poses no harm to children and has no effect on the development of epilepsies.

“The balance of evidence supports discontinuing antiseizure medication after resolution of acute symptomatic neonatal seizures and before discharge home from the neonatal seizure admission,” said Hannah C. Glass, MDCM, MAS, of the University of California, San Francisco, Benioff Children’s Hospital, co-principal investigator, who presented results of the study at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year. Renee Shellhaas, MD, MS, clinical associate professor of pediatrics at C.S. Mott Children’s Hospital, University of Michigan, was the other co-principal investigator.

“Although other, smaller studies have suggested it is safe to discontinue antiseizure medication after resolution of acute symptomatic seizures, the practice of early discontinuation has been very variable and depends largely on individual provider preference,” Dr. Glass said in an interview. “In our study, two-thirds of newborns with acute symptomatic seizures were maintained on antiseizure medication at the time of hospital discharge. Thus, a change to early medication discontinuation represents a major shift.” 

The study evaluated 270 infants at nine centers enrolled in the Neonatal Seizure Registry and born from July 2015 through March 2018. Inclusion criteria were acute symptomatic seizures that occurred at up to 44 weeks postmenstrual age. In this cohort, 36% of patients had antiseizure medication discontinued after a median of 6 days; the remainder stayed on antiseizure medication after discharge at a median of 4 months.

The patients were followed for 2 years. The primary outcome was functional development measured by the Warner Initial Development Evaluation of Adaptive and Functional Skills (WIDEA-FS) assessment. The secondary outcome was epilepsy defined by International League Against Epilepsy (ILAE) criteria. Follow-up consisted of phone calls and chart reviews at 12, 18, and 24 months.

“The primary outcome, functional development, was not significantly different between those children who were maintained on antiseizure medication as compared with those who were discontinued,” Dr. Glass said.

After propensity adjustment, the discontinued ASM group had an estimated WIDEA-FS score 4 points higher on average, she said. “The confidence intervals met our a priori noninferiority limit, indicating no harm to neurodevelopment for discontinuing antiseizure medication before discharge home from the neonatal seizure admission,” Dr. Glass noted.

The study also found that 13% of all participants developed epilepsy at a median of 8 months. “There was no significant difference in the frequency or timing of epilepsy between the two groups,” she said.

“We conclude there is no clear rationale for antiseizure medication maintenance,” Dr. Glass said. “There is no benefit to neurodevelopment, it prolongs the exposure to potentially harmful antiseizure medications, it does not significantly delay the onset of epilepsy, and the earliest-onset epilepsies occur in spite of antiseizure medication.”

The Patient-Centered Outcomes Research Institute (PCORI) and Pediatric Epilepsy Research Foundation funded the study. Dr. Glass has no other financial relationships to disclose.

SOURCE: Glass HC et al. CNS-ICNA 2020. Presentation PL58.

Maintaining antiseizure medication in infants who have had acute symptomatic neonatal seizures has been standard practice, but a prospective, observational, comparative effectiveness study calls that practice into question, providing evidence that discontinuing therapy at discharge poses no harm to children and has no effect on the development of epilepsies.

“The balance of evidence supports discontinuing antiseizure medication after resolution of acute symptomatic neonatal seizures and before discharge home from the neonatal seizure admission,” said Hannah C. Glass, MDCM, MAS, of the University of California, San Francisco, Benioff Children’s Hospital, co-principal investigator, who presented results of the study at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year. Renee Shellhaas, MD, MS, clinical associate professor of pediatrics at C.S. Mott Children’s Hospital, University of Michigan, was the other co-principal investigator.

“Although other, smaller studies have suggested it is safe to discontinue antiseizure medication after resolution of acute symptomatic seizures, the practice of early discontinuation has been very variable and depends largely on individual provider preference,” Dr. Glass said in an interview. “In our study, two-thirds of newborns with acute symptomatic seizures were maintained on antiseizure medication at the time of hospital discharge. Thus, a change to early medication discontinuation represents a major shift.” 

The study evaluated 270 infants at nine centers enrolled in the Neonatal Seizure Registry and born from July 2015 through March 2018. Inclusion criteria were acute symptomatic seizures that occurred at up to 44 weeks postmenstrual age. In this cohort, 36% of patients had antiseizure medication discontinued after a median of 6 days; the remainder stayed on antiseizure medication after discharge at a median of 4 months.

The patients were followed for 2 years. The primary outcome was functional development measured by the Warner Initial Development Evaluation of Adaptive and Functional Skills (WIDEA-FS) assessment. The secondary outcome was epilepsy defined by International League Against Epilepsy (ILAE) criteria. Follow-up consisted of phone calls and chart reviews at 12, 18, and 24 months.

“The primary outcome, functional development, was not significantly different between those children who were maintained on antiseizure medication as compared with those who were discontinued,” Dr. Glass said.

After propensity adjustment, the discontinued ASM group had an estimated WIDEA-FS score 4 points higher on average, she said. “The confidence intervals met our a priori noninferiority limit, indicating no harm to neurodevelopment for discontinuing antiseizure medication before discharge home from the neonatal seizure admission,” Dr. Glass noted.

The study also found that 13% of all participants developed epilepsy at a median of 8 months. “There was no significant difference in the frequency or timing of epilepsy between the two groups,” she said.

“We conclude there is no clear rationale for antiseizure medication maintenance,” Dr. Glass said. “There is no benefit to neurodevelopment, it prolongs the exposure to potentially harmful antiseizure medications, it does not significantly delay the onset of epilepsy, and the earliest-onset epilepsies occur in spite of antiseizure medication.”

The Patient-Centered Outcomes Research Institute (PCORI) and Pediatric Epilepsy Research Foundation funded the study. Dr. Glass has no other financial relationships to disclose.

SOURCE: Glass HC et al. CNS-ICNA 2020. Presentation PL58.

Danny Dvir, MD, has a message for physicians who have patients with severe valvular heart disease who are deferring valve replacement or repair until after the COVID-19 pandemic: Urge them not to wait.

Data from the Multicenter International Valve Disease Registry vividly demonstrate that clinical outcomes are poor in patients with uncorrected valve disease who become hospitalized with COVID-19. Indeed, the mortality rate within 30 days after hospital admission in 136 such patients enrolled in the registry from centers in Europe, North America, and Israel was 42%, Dr. Dvir reported at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.

“That’s dramatically higher than for an age-matched population infected with COVID-19 without valvular heart disease, which is 10%-15%,” he noted at the meeting sponsored by the Cardiovascular Research Foundation.

The bright spot was that, in the small subgroup of 15 registry participants who underwent transcatheter or, much less frequently, surgical treatment of their failing valve while COVID-19 infected, 30-day mortality was far lower. In fact, it was comparable with the background rate in hospitalized COVID-19 patients without valve disease, according to Dr. Dvir, an interventional cardiologist at Shaare Zedek Medical Center, Hebrew University, Jerusalem.

He personally did several of the transcatheter aortic valve replacements.

“It’s doable. I truly believe that when you get a severe aortic stenosis patient who’s infected with the coronavirus, they get very unstable, but we can treat them. We can treat them even during the infection,” Dr. Dvir said.

The majority of patients in the registry had severe aortic stenosis. In the 42 such patients aged 80 years or more who didn’t undergo transcatheter aortic valve replacement (TAVR) or surgical valve replacement, 30-day mortality was 60%. In contrast, only one of the six patients in this advanced-age category who underwent valve replacement while infected died. Similarly, 30-day mortality was 24% among those younger than age 80 who valve remained untreated, but it dropped to 11% in those who received a prosthetic valve.

“We try our best to protect our patients through social distancing, but we have a treatment that can potentially reduce their mortality risk if they get infected later on. So I say to my patients: ‘Don’t wait at home. Do not wait! If you get infected when you have severe aortic stenosis, the clinical outcome is bad.’ But it seems reasonable that if they get infected when they’ve already been treated for their aortic stenosis or mitral regurgitation, they will do better.”

Dr. Dvir noted that, although the case numbers in the registry series were small and subject to potential bias, the data suggest this treatment approach may be lifesaving.

Session comoderator Timothy D. Henry, MD, commented that this registry study contains a great take-home point: “This is really consistent with what see in a lot of the other areas of COVID, that what we know to be best clinical care, we should do it, with or without the COVID.”

He asked Dr. Dvir about any special measures he takes while doing TAVR in this extreme setting. In the United States, for example, interventionalists are increasingly using transesophageal echocardiography to guide their procedures using conscious sedation, without intubation, noted Dr. Henry, medical director of the Carl and Edyth Lindner Center for Research at the Christ Hospital, Cincinnati.

“We try to minimize the procedure time; that’s one of the important things,” Dr. Dvir replied. “And you need to be protected during the procedure in a very cautious and meticulous way. You need many fans in the room because you sweat a lot.”

Discussant Renu Virmani, MD, president of the CVPath Institute in Gaithersburg, Md., commented: “The main thing I get from this presentation is the need for patients to be educated that if you’ve got valve disease, you’re better off getting it treated before you’ve got COVID. Obviously, try to prevent getting COVID – that’s the best thing you can do – but you can’t always control that.”

Discussant Mamas Mamas, MD, professor of cardiology at Keele University, Staffordshire, England, said deferred treatment of severe valvular heart disease during the pandemic has created a looming public health crisis in the United Kingdom.

“We’ve analyzed the U.K. management of aortic stenosis, and what we’ve found is that during the COVID pandemic there have been 2,500 fewer cases of aortic stenosis that have been treated. We’ve got 2,500 patients on the waiting list, and we’ve got to work out how we’re going to treat them. We estimate with simulations that about 300 of them are going to die before we can get them treated for their aortic stenosis,” according to Dr. Mamas.

Dr. Henry commented that deferral of valve procedures is “really challenging” for a couple of reasons: Not only are patients scared to come into the hospital because they fear getting COVID, but they don’t want to be hospitalized during the pandemic because their family can’t visit them there.

“These patients are mostly over 80 years old. No one wants to come in the hospital when the family won’t be around, especially when you’re 90 years old,” the interventional cardiologist said.

Dr. Dvir reported serving as a consultant to Medtronic, Edwards Lifesciences, Abbott, and Jena.

bjancin@mdedge.com

Danny Dvir, MD, has a message for physicians who have patients with severe valvular heart disease who are deferring valve replacement or repair until after the COVID-19 pandemic: Urge them not to wait.

Data from the Multicenter International Valve Disease Registry vividly demonstrate that clinical outcomes are poor in patients with uncorrected valve disease who become hospitalized with COVID-19. Indeed, the mortality rate within 30 days after hospital admission in 136 such patients enrolled in the registry from centers in Europe, North America, and Israel was 42%, Dr. Dvir reported at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.

“That’s dramatically higher than for an age-matched population infected with COVID-19 without valvular heart disease, which is 10%-15%,” he noted at the meeting sponsored by the Cardiovascular Research Foundation.

The bright spot was that, in the small subgroup of 15 registry participants who underwent transcatheter or, much less frequently, surgical treatment of their failing valve while COVID-19 infected, 30-day mortality was far lower. In fact, it was comparable with the background rate in hospitalized COVID-19 patients without valve disease, according to Dr. Dvir, an interventional cardiologist at Shaare Zedek Medical Center, Hebrew University, Jerusalem.

He personally did several of the transcatheter aortic valve replacements.

“It’s doable. I truly believe that when you get a severe aortic stenosis patient who’s infected with the coronavirus, they get very unstable, but we can treat them. We can treat them even during the infection,” Dr. Dvir said.

The majority of patients in the registry had severe aortic stenosis. In the 42 such patients aged 80 years or more who didn’t undergo transcatheter aortic valve replacement (TAVR) or surgical valve replacement, 30-day mortality was 60%. In contrast, only one of the six patients in this advanced-age category who underwent valve replacement while infected died. Similarly, 30-day mortality was 24% among those younger than age 80 who valve remained untreated, but it dropped to 11% in those who received a prosthetic valve.

“We try our best to protect our patients through social distancing, but we have a treatment that can potentially reduce their mortality risk if they get infected later on. So I say to my patients: ‘Don’t wait at home. Do not wait! If you get infected when you have severe aortic stenosis, the clinical outcome is bad.’ But it seems reasonable that if they get infected when they’ve already been treated for their aortic stenosis or mitral regurgitation, they will do better.”

Dr. Dvir noted that, although the case numbers in the registry series were small and subject to potential bias, the data suggest this treatment approach may be lifesaving.

Session comoderator Timothy D. Henry, MD, commented that this registry study contains a great take-home point: “This is really consistent with what see in a lot of the other areas of COVID, that what we know to be best clinical care, we should do it, with or without the COVID.”

He asked Dr. Dvir about any special measures he takes while doing TAVR in this extreme setting. In the United States, for example, interventionalists are increasingly using transesophageal echocardiography to guide their procedures using conscious sedation, without intubation, noted Dr. Henry, medical director of the Carl and Edyth Lindner Center for Research at the Christ Hospital, Cincinnati.

“We try to minimize the procedure time; that’s one of the important things,” Dr. Dvir replied. “And you need to be protected during the procedure in a very cautious and meticulous way. You need many fans in the room because you sweat a lot.”

Discussant Renu Virmani, MD, president of the CVPath Institute in Gaithersburg, Md., commented: “The main thing I get from this presentation is the need for patients to be educated that if you’ve got valve disease, you’re better off getting it treated before you’ve got COVID. Obviously, try to prevent getting COVID – that’s the best thing you can do – but you can’t always control that.”

Discussant Mamas Mamas, MD, professor of cardiology at Keele University, Staffordshire, England, said deferred treatment of severe valvular heart disease during the pandemic has created a looming public health crisis in the United Kingdom.

“We’ve analyzed the U.K. management of aortic stenosis, and what we’ve found is that during the COVID pandemic there have been 2,500 fewer cases of aortic stenosis that have been treated. We’ve got 2,500 patients on the waiting list, and we’ve got to work out how we’re going to treat them. We estimate with simulations that about 300 of them are going to die before we can get them treated for their aortic stenosis,” according to Dr. Mamas.

Dr. Henry commented that deferral of valve procedures is “really challenging” for a couple of reasons: Not only are patients scared to come into the hospital because they fear getting COVID, but they don’t want to be hospitalized during the pandemic because their family can’t visit them there.

“These patients are mostly over 80 years old. No one wants to come in the hospital when the family won’t be around, especially when you’re 90 years old,” the interventional cardiologist said.

Dr. Dvir reported serving as a consultant to Medtronic, Edwards Lifesciences, Abbott, and Jena.

bjancin@mdedge.com

Danny Dvir, MD, has a message for physicians who have patients with severe valvular heart disease who are deferring valve replacement or repair until after the COVID-19 pandemic: Urge them not to wait.

Data from the Multicenter International Valve Disease Registry vividly demonstrate that clinical outcomes are poor in patients with uncorrected valve disease who become hospitalized with COVID-19. Indeed, the mortality rate within 30 days after hospital admission in 136 such patients enrolled in the registry from centers in Europe, North America, and Israel was 42%, Dr. Dvir reported at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.

“That’s dramatically higher than for an age-matched population infected with COVID-19 without valvular heart disease, which is 10%-15%,” he noted at the meeting sponsored by the Cardiovascular Research Foundation.

The bright spot was that, in the small subgroup of 15 registry participants who underwent transcatheter or, much less frequently, surgical treatment of their failing valve while COVID-19 infected, 30-day mortality was far lower. In fact, it was comparable with the background rate in hospitalized COVID-19 patients without valve disease, according to Dr. Dvir, an interventional cardiologist at Shaare Zedek Medical Center, Hebrew University, Jerusalem.

He personally did several of the transcatheter aortic valve replacements.

“It’s doable. I truly believe that when you get a severe aortic stenosis patient who’s infected with the coronavirus, they get very unstable, but we can treat them. We can treat them even during the infection,” Dr. Dvir said.

The majority of patients in the registry had severe aortic stenosis. In the 42 such patients aged 80 years or more who didn’t undergo transcatheter aortic valve replacement (TAVR) or surgical valve replacement, 30-day mortality was 60%. In contrast, only one of the six patients in this advanced-age category who underwent valve replacement while infected died. Similarly, 30-day mortality was 24% among those younger than age 80 who valve remained untreated, but it dropped to 11% in those who received a prosthetic valve.

“We try our best to protect our patients through social distancing, but we have a treatment that can potentially reduce their mortality risk if they get infected later on. So I say to my patients: ‘Don’t wait at home. Do not wait! If you get infected when you have severe aortic stenosis, the clinical outcome is bad.’ But it seems reasonable that if they get infected when they’ve already been treated for their aortic stenosis or mitral regurgitation, they will do better.”

Dr. Dvir noted that, although the case numbers in the registry series were small and subject to potential bias, the data suggest this treatment approach may be lifesaving.

Session comoderator Timothy D. Henry, MD, commented that this registry study contains a great take-home point: “This is really consistent with what see in a lot of the other areas of COVID, that what we know to be best clinical care, we should do it, with or without the COVID.”

He asked Dr. Dvir about any special measures he takes while doing TAVR in this extreme setting. In the United States, for example, interventionalists are increasingly using transesophageal echocardiography to guide their procedures using conscious sedation, without intubation, noted Dr. Henry, medical director of the Carl and Edyth Lindner Center for Research at the Christ Hospital, Cincinnati.

“We try to minimize the procedure time; that’s one of the important things,” Dr. Dvir replied. “And you need to be protected during the procedure in a very cautious and meticulous way. You need many fans in the room because you sweat a lot.”

Discussant Renu Virmani, MD, president of the CVPath Institute in Gaithersburg, Md., commented: “The main thing I get from this presentation is the need for patients to be educated that if you’ve got valve disease, you’re better off getting it treated before you’ve got COVID. Obviously, try to prevent getting COVID – that’s the best thing you can do – but you can’t always control that.”

Discussant Mamas Mamas, MD, professor of cardiology at Keele University, Staffordshire, England, said deferred treatment of severe valvular heart disease during the pandemic has created a looming public health crisis in the United Kingdom.

“We’ve analyzed the U.K. management of aortic stenosis, and what we’ve found is that during the COVID pandemic there have been 2,500 fewer cases of aortic stenosis that have been treated. We’ve got 2,500 patients on the waiting list, and we’ve got to work out how we’re going to treat them. We estimate with simulations that about 300 of them are going to die before we can get them treated for their aortic stenosis,” according to Dr. Mamas.

Dr. Henry commented that deferral of valve procedures is “really challenging” for a couple of reasons: Not only are patients scared to come into the hospital because they fear getting COVID, but they don’t want to be hospitalized during the pandemic because their family can’t visit them there.

“These patients are mostly over 80 years old. No one wants to come in the hospital when the family won’t be around, especially when you’re 90 years old,” the interventional cardiologist said.

Dr. Dvir reported serving as a consultant to Medtronic, Edwards Lifesciences, Abbott, and Jena.

bjancin@mdedge.com

Major thromboembolic complications and adverse cardiovascular events occurred with high frequency in patients with COVID-19, especially in the intensive care setting, despite a high use of thromboprophylaxis, in a new large observational U.S. study.

“Despite very high rate of antithrombotic prophylaxis there were a high rate of thromboembolic events suggesting that we are probably not providing enough thromboprophylaxis,” lead author Gregory Piazza, MD, Brigham and Women’s Hospital, Boston, said in an interview. 

“Standard prophylaxis as recommended in the guidelines is a low dose of low-molecular-weight heparin once daily, but these results suggest [patients] probably need higher doses,” he added.

However, Dr. Piazza cautioned that this is an observational study and randomized trials are needed to make changes in treatment strategies. Several such trials are currently underway.

The current study was published online ahead of print in the Nov. 3 issue of the Journal of the American College of Cardiology.
 

Rates similar to other very sick patients

The study showed that while thromboembolic complications were high, they were not as high as seen in some of the earlier studies from Asia and Europe, Dr. Piazza noted.

“The numbers we were seeing in early reports were so high we couldn’t figure out how that was possible,” he said. “Our study suggests that, in a U.S. population receiving thromboprophylaxis, the rate of thromboembolic complications [are] more in line with what we would expect to see in other very sick patients who end up in ICU.”

He suggested that the very high rates of thromboembolic complications in the early studies from Asia may have been because of the lack of thromboprophylaxis, which is not routine in hospitalized patients there. “Some of the earlier studies also used routine ultrasound and so picked up asymptomatic thrombotic events, which was not the case in our study. So our results are more representative of the U.S. population.”

Dr. Piazza attributed the high rate of thromboembolic complications being reported with COVID-19 to the sheer number of very sick patients being admitted to the hospital.

“We are accustomed to seeing a rare case of thrombosis despite prophylaxis in hospitalized patients, but we are seeing more in COVID patients. This is probably just because we have more critically ill patients,” he said.

“We are seeing an incredible influx of patients to the ICU that we have never experienced before, so the increase in thromboembolic complications is more obvious. In prior years we probably haven’t had enough critically ill patients at any one time to raise the flag about thromboprophylaxis,” he commented.

The study also found a high rate of cardiovascular complications. They are seeing an increase in the risk of MI, which is to be expected in such sick patients, but they also see quite a bit of new atrial fibrillation, myocarditis, and heart failure in patients who don’t always have underlying cardiovascular disease, he said.

“So this virus does appear to have a predilection to causing cardiovascular complications, but this is probably because it is making patients so sick,” Dr. Piazza said. “If flu was this virulent and resulted in such high rates of acute respiratory distress syndrome (ARDS), we would probably see similar cardiovascular complication rates.”

For the current report, the researchers analyzed a retrospective cohort of 1,114 patients with COVID-19 diagnosed through the Mass General Brigham integrated health network. Of these, 170 had been admitted to the ICU, 229 had been hospitalized but not treated in ICU, and 715 were outpatients. In terms of ethnicity, 22% were Hispanic/Latino and 44% were non-White. 

Cardiovascular risk factors were common, with 36% of patients having hypertension, 29% hyperlipidemia, and 18% diabetes. Prophylactic anticoagulation was prescribed in 89% of patients with COVID-19 in the intensive care cohort and 85% of those in the hospitalized non–intensive care setting.

Results showed that major arterial or venous thromboembolism (VTE) occurred in 35% of the intensive care cohort, 2.6% of those hospitalized but not treated in ICU, and 0% of outpatients.

Major adverse cardiovascular events occurred in 46% of the intensive care cohort, 6.1% of those hospitalized but non-ICU, and 0% of outpatients.

Symptomatic VTE occurred in 27% of those admitted to ICU, 2.2% of those hospitalized but non-ICU, and 0% of outpatients.

“We found that outpatients had a very low rate of thromboembolic complications, with the vast majority of the risk being in hospitalized patients, especially those in ICU,” Dr. Piazza said.

“These results suggest that we don’t need routine thromboprophylaxis for all outpatients with COVID-19, but there will probably be some patients who need it – those with risk factors for thromboembolism.”

Catheter- and device-associated deep vein thrombosis accounted for 76.9% of the DVTs observed in the study.

“Our finding of high frequency of catheter-associated DVT supports the judicious use of central venous catheters that have been widely implemented, especially in the ICU, to minimize recurrent health care team exposure and facilitate monitoring,” the researchers wrote.
 

ARDS biggest risk factor

Of all the markers of disease severity, the presence of ARDS had the strongest association with adverse outcomes, including major arterial or VTE, major adverse cardiovascular events, symptomatic VTE, and death.

“The severe inflammatory state associated with ARDS and other complications of COVID-19 and its resultant hypercoagulability may explain, at least in part, the high frequency of thromboembolic events. Improved risk stratification, utilizing biochemical markers of inflammation and activated coagulation as well as clinical indicators, such as ARDS, may play an important role in the early identification of patients with an increased likelihood of developing symptomatic VTE or arterial thrombosis,” the researchers wrote. “They may benefit from full- or intermediate-intensity antithrombotic therapy rather than prophylactic anticoagulation.”

They point out that this study provides a cross-sectional view of the cardiovascular complications of COVID-19 in a large health care network, consisting of two academic medical centers serving the greater Boston area, several community hospitals, and numerous outpatient care sites.

“The study incorporates a wide scope of clinically meaningful cardiovascular endpoints and utilizes a rigorous process of event adjudication. Although data on patients with COVID-19 in the ICU have been the subject of most reports, our study provides insights into the broad spectrum of all hospitalized and outpatient populations,” the authors noted.

“The high frequency of arterial or venous thromboembolism in hospitalized patients despite routine thromboprophylaxis suggests the need for improved risk stratification and enhanced preventive efforts,” they concluded.

The study is continuing, and the researchers expect to have data on 10,000 patients by the end of winter.
 

Wait for randomized trials

In an accompanying editorial, Robert McBane, MD, Mayo Clinic, Rochester, Minn., said that these data provide important real-world arterial and venous thrombotic event rates across a large, integrated health care network and an experienced roster of clinician-scientists devoted to thrombosis research.

Noting that whether to interpret these results as alarming or reassuring requires a comparison of expected thromboembolic event rates separate from the pandemic, he pointed out that, while the overall VTE rate among ICU patients was high, the vast majority of these events were attributable to central venous lines, and apart from these, the event rates do not appear inflated relative to prior published incidence rates from the pre–COVID-19 era.

“It is therefore important to resist the urge to overprevent or overtreat patients and expose them to the serious risks of major bleeding,” Dr. McBane wrote, adding that “the systematized approach to delivery of guideline-driven VTE prophylaxis across this large, integrated health network likely contributed to the relatively low rates of serious thrombotic outcomes reported.”

He further noted that, as the majority of VTE events were related to central venous lines in ICU patients, “this underscores the importance of a bundled care approach to central venous line management with daily assessment of the continued necessity of central access.

“A number of important clinical trials aimed at optimizing thromboprophylaxis during hospitalization, following hospital dismissal, and in ambulatory settings are underway. Until available, the lessons of thoughtful anticoagulant prophylaxis and treatment guidelines harvested from years of clinical research appear to apply,” he concluded.

This study was funded, in part, by a research grant from Janssen Pharmaceuticals. Dr. Piazza has received research grant support from EKOS Corporation, Bayer, Bristol-Myers Squibb/Pfizer, Portola Pharmaceuticals, and Janssen Pharmaceuticals; and has received consulting fees from Amgen, Pfizer, Boston Scientific, Agile, and Thrombolex. Dr. McBane reported no relevant disclosures.

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

Major thromboembolic complications and adverse cardiovascular events occurred with high frequency in patients with COVID-19, especially in the intensive care setting, despite a high use of thromboprophylaxis, in a new large observational U.S. study.

“Despite very high rate of antithrombotic prophylaxis there were a high rate of thromboembolic events suggesting that we are probably not providing enough thromboprophylaxis,” lead author Gregory Piazza, MD, Brigham and Women’s Hospital, Boston, said in an interview. 

“Standard prophylaxis as recommended in the guidelines is a low dose of low-molecular-weight heparin once daily, but these results suggest [patients] probably need higher doses,” he added.

However, Dr. Piazza cautioned that this is an observational study and randomized trials are needed to make changes in treatment strategies. Several such trials are currently underway.

The current study was published online ahead of print in the Nov. 3 issue of the Journal of the American College of Cardiology.
 

Rates similar to other very sick patients

The study showed that while thromboembolic complications were high, they were not as high as seen in some of the earlier studies from Asia and Europe, Dr. Piazza noted.

“The numbers we were seeing in early reports were so high we couldn’t figure out how that was possible,” he said. “Our study suggests that, in a U.S. population receiving thromboprophylaxis, the rate of thromboembolic complications [are] more in line with what we would expect to see in other very sick patients who end up in ICU.”

He suggested that the very high rates of thromboembolic complications in the early studies from Asia may have been because of the lack of thromboprophylaxis, which is not routine in hospitalized patients there. “Some of the earlier studies also used routine ultrasound and so picked up asymptomatic thrombotic events, which was not the case in our study. So our results are more representative of the U.S. population.”

Dr. Piazza attributed the high rate of thromboembolic complications being reported with COVID-19 to the sheer number of very sick patients being admitted to the hospital.

“We are accustomed to seeing a rare case of thrombosis despite prophylaxis in hospitalized patients, but we are seeing more in COVID patients. This is probably just because we have more critically ill patients,” he said.

“We are seeing an incredible influx of patients to the ICU that we have never experienced before, so the increase in thromboembolic complications is more obvious. In prior years we probably haven’t had enough critically ill patients at any one time to raise the flag about thromboprophylaxis,” he commented.

The study also found a high rate of cardiovascular complications. They are seeing an increase in the risk of MI, which is to be expected in such sick patients, but they also see quite a bit of new atrial fibrillation, myocarditis, and heart failure in patients who don’t always have underlying cardiovascular disease, he said.

“So this virus does appear to have a predilection to causing cardiovascular complications, but this is probably because it is making patients so sick,” Dr. Piazza said. “If flu was this virulent and resulted in such high rates of acute respiratory distress syndrome (ARDS), we would probably see similar cardiovascular complication rates.”

For the current report, the researchers analyzed a retrospective cohort of 1,114 patients with COVID-19 diagnosed through the Mass General Brigham integrated health network. Of these, 170 had been admitted to the ICU, 229 had been hospitalized but not treated in ICU, and 715 were outpatients. In terms of ethnicity, 22% were Hispanic/Latino and 44% were non-White. 

Cardiovascular risk factors were common, with 36% of patients having hypertension, 29% hyperlipidemia, and 18% diabetes. Prophylactic anticoagulation was prescribed in 89% of patients with COVID-19 in the intensive care cohort and 85% of those in the hospitalized non–intensive care setting.

Results showed that major arterial or venous thromboembolism (VTE) occurred in 35% of the intensive care cohort, 2.6% of those hospitalized but not treated in ICU, and 0% of outpatients.

Major adverse cardiovascular events occurred in 46% of the intensive care cohort, 6.1% of those hospitalized but non-ICU, and 0% of outpatients.

Symptomatic VTE occurred in 27% of those admitted to ICU, 2.2% of those hospitalized but non-ICU, and 0% of outpatients.

“We found that outpatients had a very low rate of thromboembolic complications, with the vast majority of the risk being in hospitalized patients, especially those in ICU,” Dr. Piazza said.

“These results suggest that we don’t need routine thromboprophylaxis for all outpatients with COVID-19, but there will probably be some patients who need it – those with risk factors for thromboembolism.”

Catheter- and device-associated deep vein thrombosis accounted for 76.9% of the DVTs observed in the study.

“Our finding of high frequency of catheter-associated DVT supports the judicious use of central venous catheters that have been widely implemented, especially in the ICU, to minimize recurrent health care team exposure and facilitate monitoring,” the researchers wrote.
 

ARDS biggest risk factor

Of all the markers of disease severity, the presence of ARDS had the strongest association with adverse outcomes, including major arterial or VTE, major adverse cardiovascular events, symptomatic VTE, and death.

“The severe inflammatory state associated with ARDS and other complications of COVID-19 and its resultant hypercoagulability may explain, at least in part, the high frequency of thromboembolic events. Improved risk stratification, utilizing biochemical markers of inflammation and activated coagulation as well as clinical indicators, such as ARDS, may play an important role in the early identification of patients with an increased likelihood of developing symptomatic VTE or arterial thrombosis,” the researchers wrote. “They may benefit from full- or intermediate-intensity antithrombotic therapy rather than prophylactic anticoagulation.”

They point out that this study provides a cross-sectional view of the cardiovascular complications of COVID-19 in a large health care network, consisting of two academic medical centers serving the greater Boston area, several community hospitals, and numerous outpatient care sites.

“The study incorporates a wide scope of clinically meaningful cardiovascular endpoints and utilizes a rigorous process of event adjudication. Although data on patients with COVID-19 in the ICU have been the subject of most reports, our study provides insights into the broad spectrum of all hospitalized and outpatient populations,” the authors noted.

“The high frequency of arterial or venous thromboembolism in hospitalized patients despite routine thromboprophylaxis suggests the need for improved risk stratification and enhanced preventive efforts,” they concluded.

The study is continuing, and the researchers expect to have data on 10,000 patients by the end of winter.
 

Wait for randomized trials

In an accompanying editorial, Robert McBane, MD, Mayo Clinic, Rochester, Minn., said that these data provide important real-world arterial and venous thrombotic event rates across a large, integrated health care network and an experienced roster of clinician-scientists devoted to thrombosis research.

Noting that whether to interpret these results as alarming or reassuring requires a comparison of expected thromboembolic event rates separate from the pandemic, he pointed out that, while the overall VTE rate among ICU patients was high, the vast majority of these events were attributable to central venous lines, and apart from these, the event rates do not appear inflated relative to prior published incidence rates from the pre–COVID-19 era.

“It is therefore important to resist the urge to overprevent or overtreat patients and expose them to the serious risks of major bleeding,” Dr. McBane wrote, adding that “the systematized approach to delivery of guideline-driven VTE prophylaxis across this large, integrated health network likely contributed to the relatively low rates of serious thrombotic outcomes reported.”

He further noted that, as the majority of VTE events were related to central venous lines in ICU patients, “this underscores the importance of a bundled care approach to central venous line management with daily assessment of the continued necessity of central access.

“A number of important clinical trials aimed at optimizing thromboprophylaxis during hospitalization, following hospital dismissal, and in ambulatory settings are underway. Until available, the lessons of thoughtful anticoagulant prophylaxis and treatment guidelines harvested from years of clinical research appear to apply,” he concluded.

This study was funded, in part, by a research grant from Janssen Pharmaceuticals. Dr. Piazza has received research grant support from EKOS Corporation, Bayer, Bristol-Myers Squibb/Pfizer, Portola Pharmaceuticals, and Janssen Pharmaceuticals; and has received consulting fees from Amgen, Pfizer, Boston Scientific, Agile, and Thrombolex. Dr. McBane reported no relevant disclosures.

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

Major thromboembolic complications and adverse cardiovascular events occurred with high frequency in patients with COVID-19, especially in the intensive care setting, despite a high use of thromboprophylaxis, in a new large observational U.S. study.

“Despite very high rate of antithrombotic prophylaxis there were a high rate of thromboembolic events suggesting that we are probably not providing enough thromboprophylaxis,” lead author Gregory Piazza, MD, Brigham and Women’s Hospital, Boston, said in an interview. 

“Standard prophylaxis as recommended in the guidelines is a low dose of low-molecular-weight heparin once daily, but these results suggest [patients] probably need higher doses,” he added.

However, Dr. Piazza cautioned that this is an observational study and randomized trials are needed to make changes in treatment strategies. Several such trials are currently underway.

The current study was published online ahead of print in the Nov. 3 issue of the Journal of the American College of Cardiology.
 

Rates similar to other very sick patients

The study showed that while thromboembolic complications were high, they were not as high as seen in some of the earlier studies from Asia and Europe, Dr. Piazza noted.

“The numbers we were seeing in early reports were so high we couldn’t figure out how that was possible,” he said. “Our study suggests that, in a U.S. population receiving thromboprophylaxis, the rate of thromboembolic complications [are] more in line with what we would expect to see in other very sick patients who end up in ICU.”

He suggested that the very high rates of thromboembolic complications in the early studies from Asia may have been because of the lack of thromboprophylaxis, which is not routine in hospitalized patients there. “Some of the earlier studies also used routine ultrasound and so picked up asymptomatic thrombotic events, which was not the case in our study. So our results are more representative of the U.S. population.”

Dr. Piazza attributed the high rate of thromboembolic complications being reported with COVID-19 to the sheer number of very sick patients being admitted to the hospital.

“We are accustomed to seeing a rare case of thrombosis despite prophylaxis in hospitalized patients, but we are seeing more in COVID patients. This is probably just because we have more critically ill patients,” he said.

“We are seeing an incredible influx of patients to the ICU that we have never experienced before, so the increase in thromboembolic complications is more obvious. In prior years we probably haven’t had enough critically ill patients at any one time to raise the flag about thromboprophylaxis,” he commented.

The study also found a high rate of cardiovascular complications. They are seeing an increase in the risk of MI, which is to be expected in such sick patients, but they also see quite a bit of new atrial fibrillation, myocarditis, and heart failure in patients who don’t always have underlying cardiovascular disease, he said.

“So this virus does appear to have a predilection to causing cardiovascular complications, but this is probably because it is making patients so sick,” Dr. Piazza said. “If flu was this virulent and resulted in such high rates of acute respiratory distress syndrome (ARDS), we would probably see similar cardiovascular complication rates.”

For the current report, the researchers analyzed a retrospective cohort of 1,114 patients with COVID-19 diagnosed through the Mass General Brigham integrated health network. Of these, 170 had been admitted to the ICU, 229 had been hospitalized but not treated in ICU, and 715 were outpatients. In terms of ethnicity, 22% were Hispanic/Latino and 44% were non-White. 

Cardiovascular risk factors were common, with 36% of patients having hypertension, 29% hyperlipidemia, and 18% diabetes. Prophylactic anticoagulation was prescribed in 89% of patients with COVID-19 in the intensive care cohort and 85% of those in the hospitalized non–intensive care setting.

Results showed that major arterial or venous thromboembolism (VTE) occurred in 35% of the intensive care cohort, 2.6% of those hospitalized but not treated in ICU, and 0% of outpatients.

Major adverse cardiovascular events occurred in 46% of the intensive care cohort, 6.1% of those hospitalized but non-ICU, and 0% of outpatients.

Symptomatic VTE occurred in 27% of those admitted to ICU, 2.2% of those hospitalized but non-ICU, and 0% of outpatients.

“We found that outpatients had a very low rate of thromboembolic complications, with the vast majority of the risk being in hospitalized patients, especially those in ICU,” Dr. Piazza said.

“These results suggest that we don’t need routine thromboprophylaxis for all outpatients with COVID-19, but there will probably be some patients who need it – those with risk factors for thromboembolism.”

Catheter- and device-associated deep vein thrombosis accounted for 76.9% of the DVTs observed in the study.

“Our finding of high frequency of catheter-associated DVT supports the judicious use of central venous catheters that have been widely implemented, especially in the ICU, to minimize recurrent health care team exposure and facilitate monitoring,” the researchers wrote.
 

ARDS biggest risk factor

Of all the markers of disease severity, the presence of ARDS had the strongest association with adverse outcomes, including major arterial or VTE, major adverse cardiovascular events, symptomatic VTE, and death.

“The severe inflammatory state associated with ARDS and other complications of COVID-19 and its resultant hypercoagulability may explain, at least in part, the high frequency of thromboembolic events. Improved risk stratification, utilizing biochemical markers of inflammation and activated coagulation as well as clinical indicators, such as ARDS, may play an important role in the early identification of patients with an increased likelihood of developing symptomatic VTE or arterial thrombosis,” the researchers wrote. “They may benefit from full- or intermediate-intensity antithrombotic therapy rather than prophylactic anticoagulation.”

They point out that this study provides a cross-sectional view of the cardiovascular complications of COVID-19 in a large health care network, consisting of two academic medical centers serving the greater Boston area, several community hospitals, and numerous outpatient care sites.

“The study incorporates a wide scope of clinically meaningful cardiovascular endpoints and utilizes a rigorous process of event adjudication. Although data on patients with COVID-19 in the ICU have been the subject of most reports, our study provides insights into the broad spectrum of all hospitalized and outpatient populations,” the authors noted.

“The high frequency of arterial or venous thromboembolism in hospitalized patients despite routine thromboprophylaxis suggests the need for improved risk stratification and enhanced preventive efforts,” they concluded.

The study is continuing, and the researchers expect to have data on 10,000 patients by the end of winter.
 

Wait for randomized trials

In an accompanying editorial, Robert McBane, MD, Mayo Clinic, Rochester, Minn., said that these data provide important real-world arterial and venous thrombotic event rates across a large, integrated health care network and an experienced roster of clinician-scientists devoted to thrombosis research.

Noting that whether to interpret these results as alarming or reassuring requires a comparison of expected thromboembolic event rates separate from the pandemic, he pointed out that, while the overall VTE rate among ICU patients was high, the vast majority of these events were attributable to central venous lines, and apart from these, the event rates do not appear inflated relative to prior published incidence rates from the pre–COVID-19 era.

“It is therefore important to resist the urge to overprevent or overtreat patients and expose them to the serious risks of major bleeding,” Dr. McBane wrote, adding that “the systematized approach to delivery of guideline-driven VTE prophylaxis across this large, integrated health network likely contributed to the relatively low rates of serious thrombotic outcomes reported.”

He further noted that, as the majority of VTE events were related to central venous lines in ICU patients, “this underscores the importance of a bundled care approach to central venous line management with daily assessment of the continued necessity of central access.

“A number of important clinical trials aimed at optimizing thromboprophylaxis during hospitalization, following hospital dismissal, and in ambulatory settings are underway. Until available, the lessons of thoughtful anticoagulant prophylaxis and treatment guidelines harvested from years of clinical research appear to apply,” he concluded.

This study was funded, in part, by a research grant from Janssen Pharmaceuticals. Dr. Piazza has received research grant support from EKOS Corporation, Bayer, Bristol-Myers Squibb/Pfizer, Portola Pharmaceuticals, and Janssen Pharmaceuticals; and has received consulting fees from Amgen, Pfizer, Boston Scientific, Agile, and Thrombolex. Dr. McBane reported no relevant disclosures.

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

Obstructive sleep apnea diagnoses may not be carried over to the inpatient setting, with potentially negative consequences for clinical outcomes, quality of life, and health care costs, an investigator said at the virtual meeting of the American College of Chest Physicians.

In a retrospective, single-center study, nearly 40% of patients with obstructive sleep apnea (OSA) diagnosed in the outpatient setting did not have a corresponding diagnosis during hospitalization, according to researcher Nitasa Sahu, MD.*

The missed OSA diagnoses could have especially negative implications for patients who don’t continue on positive airway pressure (PAP) therapy during the hospital stay, said Dr. Sahu, a fellow in pulmonary/critical care at St. Luke’s University Health Network in Bethlehem, Pa.

The finding indicates a large-magnitude opportunity to improve health care through better communication and optimized care, according to the researcher.

“Obstructive sleep apnea is underrecognized, it’s underdiagnosed, and it has a lot of implications for a patient’s hospitalization,” she said in interview

Clinical pathways should be set up to ensure that patients with OSA are properly identified and use their prescribed treatment, according to Dr. Sahu.

“I think that should, and would, reduce overall health care costs, with better outcomes as well,” she said.

Pulmonologist Saadia A. Faiz, MD, FCCP, said she hoped this study, presented at a late-breaking abstract at the virtual meeting, would highlight the importance of OSA screening and call attention to barriers to screening that may be in place in the inpatient setting.

That’s especially important because, after admission, the focus is often on the cause of admission rather than underlying comorbidities such as OSA, said Dr. Faiz, professor in the department of pulmonary medicine at the University of Texas MD Anderson Cancer Center in Houston.

“Working in a cancer hospital, the focus is always on the cancer, so sometimes even the patient will dismiss issues with their sleep,” Dr. Faiz said of her own experience in an interview.

“Often with sleep apnea, for people in the general population, the reason they seek medical attention is because their spouse notices that they’re snoring, so it is something that is not as emphasized,” added Dr. Faiz, who was not involved in the study.

In their study, Dr. Sahu and coauthors reviewed electronic health record data for adults hospitalized on the general internal medicine service at Penn State Hershey Medical Center from January 2017 through 2018. They restricted their search to first admissions.

The researchers looked for ICD-9 codes indicating an OSA diagnosis during their inpatient admission. They looked for the same codes in the preceding 5 years to see if the patients had a prior outpatient OSA diagnosis.

The inpatient cohort included 13,067 patients, of whom 53% were male, 87% were White, and 77% were over 50 years of age. Comorbidities included hypertension in 42%, atrial fibrillation in 21%, type 2 diabetes mellitus in 14%, congestive heart failure in 15%, and prior stroke in 0.5%.

A total of 991 individuals in the inpatient cohort had a prior outpatient OSA diagnosis. Of that group, 376 patients (38%) did not have an inpatient OSA diagnosis on inpatient record, according to the reported study data.

That large proportion of discordant diagnoses suggests a lot of missed opportunities to provide OSA therapy in the inpatient setting and to reinforce chronic disease state management, according to Dr. Sahu and colleagues.

How those discordant OSA diagnoses impact length of stay, cost of care, and readmissions are unanswered questions that deserve further study, Dr. Sahu said.

Among patients who did not have outpatient OSA diagnoses, another 804 patients, or about 6%, ended up with an inpatient diagnosis during their hospitalization, the researchers also reported.

While a number of those inpatient OSA diagnoses could have been coded in error, it’s also possible that they were indeed cases of OSA that went unrecognized until the individuals were hospitalized, Dr. Sahu said.

Dr. Sahu had no relevant relationships to report related to the study. One of four study coauthors reported relationships with Boehringer-Ingelheim, Nitto Denko, and Galapagos.

SOURCE: Sahu N. CHEST 2020. Abstract.

*Correction, 11/3/20: An earlier version of this article misstated the name of Nitasa Sahu, MD.

Obstructive sleep apnea diagnoses may not be carried over to the inpatient setting, with potentially negative consequences for clinical outcomes, quality of life, and health care costs, an investigator said at the virtual meeting of the American College of Chest Physicians.

In a retrospective, single-center study, nearly 40% of patients with obstructive sleep apnea (OSA) diagnosed in the outpatient setting did not have a corresponding diagnosis during hospitalization, according to researcher Nitasa Sahu, MD.*

The missed OSA diagnoses could have especially negative implications for patients who don’t continue on positive airway pressure (PAP) therapy during the hospital stay, said Dr. Sahu, a fellow in pulmonary/critical care at St. Luke’s University Health Network in Bethlehem, Pa.

The finding indicates a large-magnitude opportunity to improve health care through better communication and optimized care, according to the researcher.

“Obstructive sleep apnea is underrecognized, it’s underdiagnosed, and it has a lot of implications for a patient’s hospitalization,” she said in interview

Clinical pathways should be set up to ensure that patients with OSA are properly identified and use their prescribed treatment, according to Dr. Sahu.

“I think that should, and would, reduce overall health care costs, with better outcomes as well,” she said.

Pulmonologist Saadia A. Faiz, MD, FCCP, said she hoped this study, presented at a late-breaking abstract at the virtual meeting, would highlight the importance of OSA screening and call attention to barriers to screening that may be in place in the inpatient setting.

That’s especially important because, after admission, the focus is often on the cause of admission rather than underlying comorbidities such as OSA, said Dr. Faiz, professor in the department of pulmonary medicine at the University of Texas MD Anderson Cancer Center in Houston.

“Working in a cancer hospital, the focus is always on the cancer, so sometimes even the patient will dismiss issues with their sleep,” Dr. Faiz said of her own experience in an interview.

“Often with sleep apnea, for people in the general population, the reason they seek medical attention is because their spouse notices that they’re snoring, so it is something that is not as emphasized,” added Dr. Faiz, who was not involved in the study.

In their study, Dr. Sahu and coauthors reviewed electronic health record data for adults hospitalized on the general internal medicine service at Penn State Hershey Medical Center from January 2017 through 2018. They restricted their search to first admissions.

The researchers looked for ICD-9 codes indicating an OSA diagnosis during their inpatient admission. They looked for the same codes in the preceding 5 years to see if the patients had a prior outpatient OSA diagnosis.

The inpatient cohort included 13,067 patients, of whom 53% were male, 87% were White, and 77% were over 50 years of age. Comorbidities included hypertension in 42%, atrial fibrillation in 21%, type 2 diabetes mellitus in 14%, congestive heart failure in 15%, and prior stroke in 0.5%.

A total of 991 individuals in the inpatient cohort had a prior outpatient OSA diagnosis. Of that group, 376 patients (38%) did not have an inpatient OSA diagnosis on inpatient record, according to the reported study data.

That large proportion of discordant diagnoses suggests a lot of missed opportunities to provide OSA therapy in the inpatient setting and to reinforce chronic disease state management, according to Dr. Sahu and colleagues.

How those discordant OSA diagnoses impact length of stay, cost of care, and readmissions are unanswered questions that deserve further study, Dr. Sahu said.

Among patients who did not have outpatient OSA diagnoses, another 804 patients, or about 6%, ended up with an inpatient diagnosis during their hospitalization, the researchers also reported.

While a number of those inpatient OSA diagnoses could have been coded in error, it’s also possible that they were indeed cases of OSA that went unrecognized until the individuals were hospitalized, Dr. Sahu said.

Dr. Sahu had no relevant relationships to report related to the study. One of four study coauthors reported relationships with Boehringer-Ingelheim, Nitto Denko, and Galapagos.

SOURCE: Sahu N. CHEST 2020. Abstract.

*Correction, 11/3/20: An earlier version of this article misstated the name of Nitasa Sahu, MD.

Obstructive sleep apnea diagnoses may not be carried over to the inpatient setting, with potentially negative consequences for clinical outcomes, quality of life, and health care costs, an investigator said at the virtual meeting of the American College of Chest Physicians.

In a retrospective, single-center study, nearly 40% of patients with obstructive sleep apnea (OSA) diagnosed in the outpatient setting did not have a corresponding diagnosis during hospitalization, according to researcher Nitasa Sahu, MD.*

The missed OSA diagnoses could have especially negative implications for patients who don’t continue on positive airway pressure (PAP) therapy during the hospital stay, said Dr. Sahu, a fellow in pulmonary/critical care at St. Luke’s University Health Network in Bethlehem, Pa.

The finding indicates a large-magnitude opportunity to improve health care through better communication and optimized care, according to the researcher.

“Obstructive sleep apnea is underrecognized, it’s underdiagnosed, and it has a lot of implications for a patient’s hospitalization,” she said in interview

Clinical pathways should be set up to ensure that patients with OSA are properly identified and use their prescribed treatment, according to Dr. Sahu.

“I think that should, and would, reduce overall health care costs, with better outcomes as well,” she said.

Pulmonologist Saadia A. Faiz, MD, FCCP, said she hoped this study, presented at a late-breaking abstract at the virtual meeting, would highlight the importance of OSA screening and call attention to barriers to screening that may be in place in the inpatient setting.

That’s especially important because, after admission, the focus is often on the cause of admission rather than underlying comorbidities such as OSA, said Dr. Faiz, professor in the department of pulmonary medicine at the University of Texas MD Anderson Cancer Center in Houston.

“Working in a cancer hospital, the focus is always on the cancer, so sometimes even the patient will dismiss issues with their sleep,” Dr. Faiz said of her own experience in an interview.

“Often with sleep apnea, for people in the general population, the reason they seek medical attention is because their spouse notices that they’re snoring, so it is something that is not as emphasized,” added Dr. Faiz, who was not involved in the study.

In their study, Dr. Sahu and coauthors reviewed electronic health record data for adults hospitalized on the general internal medicine service at Penn State Hershey Medical Center from January 2017 through 2018. They restricted their search to first admissions.

The researchers looked for ICD-9 codes indicating an OSA diagnosis during their inpatient admission. They looked for the same codes in the preceding 5 years to see if the patients had a prior outpatient OSA diagnosis.

The inpatient cohort included 13,067 patients, of whom 53% were male, 87% were White, and 77% were over 50 years of age. Comorbidities included hypertension in 42%, atrial fibrillation in 21%, type 2 diabetes mellitus in 14%, congestive heart failure in 15%, and prior stroke in 0.5%.

A total of 991 individuals in the inpatient cohort had a prior outpatient OSA diagnosis. Of that group, 376 patients (38%) did not have an inpatient OSA diagnosis on inpatient record, according to the reported study data.

That large proportion of discordant diagnoses suggests a lot of missed opportunities to provide OSA therapy in the inpatient setting and to reinforce chronic disease state management, according to Dr. Sahu and colleagues.

How those discordant OSA diagnoses impact length of stay, cost of care, and readmissions are unanswered questions that deserve further study, Dr. Sahu said.

Among patients who did not have outpatient OSA diagnoses, another 804 patients, or about 6%, ended up with an inpatient diagnosis during their hospitalization, the researchers also reported.

While a number of those inpatient OSA diagnoses could have been coded in error, it’s also possible that they were indeed cases of OSA that went unrecognized until the individuals were hospitalized, Dr. Sahu said.

Dr. Sahu had no relevant relationships to report related to the study. One of four study coauthors reported relationships with Boehringer-Ingelheim, Nitto Denko, and Galapagos.

SOURCE: Sahu N. CHEST 2020. Abstract.

*Correction, 11/3/20: An earlier version of this article misstated the name of Nitasa Sahu, MD.

Last spring, when Cliff Willmeng, RN, was working at United Hospital in St. Paul, Minnesota, he’d take off his personal protective equipment (PPE) in the same hallway where children were transported from ambulances to the neighboring Children’s Hospital emergency department. Stretchers would roll across red tape on the floor that designated the area as a “hot zone.” The door from a break room was about 10 feet away.

Willmeng has been a union activist all his life, but he’d never filed a complaint with the Occupational Safety and Health Administration (OSHA) until the COVID-19 pandemic hit.

Concerned about the inadequate space for doffing PPE and other situations in which the spread of SARS-CoV-2 seemed possible, Willmeng and other colleagues filed multiple OSHA complaints with the Minnesota Department of Labor in March and April. Willmeng was also worried about bringing SARS-CoV-2 on his scrubs home to his wife and kids, and he started wearing hospital-supplied scrubs that were meant for doctors and that were washed on site, which was against hospital policy. The hospital fired Willmeng on May 8, citing code of conduct and respectful workplace violations arising from the uniform dispute.

In August, the state agency issued Willmeng’s hospital a $2,100 fine for failure to comply with guidance regarding “respiratory protection” in response to worker complaints over the fact that they were instructed to restaple elastic bands on N95 masks early in the pandemic. In a statement, United Hospital said it contested the citation, and it is in discussions with Minnesota OSHA. “We have and continue to instruct employees not to alter N95 respirators or reuse damaged or soiled N95 respirators,” such as when the straps are broken, the statement says.

Minnesota OSHA has received three times as many emails and phone calls from workers and employers requesting information and assistance during the pandemic, compared with last year, said spokesperson James Honerman. “If Minnesota OSHA is made aware of a workplace safety or health issue, it assesses the situation and determines how best to respond, including conducting a workplace investigation.”

But Willmeng, who has been out of work since he was fired, says that without a receipt or confirmation from OSHA, he has no way of knowing whether there has been any follow-up regarding his complaints. Minnesota OSHA said workers should receive a letter once a case is resolved.

Like Willmeng’s case, none of the more than 10,000 COVID-related complaints the federal OSHA office has received from across the country have resulted in meaningful sanctions. Unions have picketed local OSHA offices and publicized complaints on behalf of their members to protest what they see as a lack of oversight. Legislators have called on US Department of Labor Secretary Eugene Scalia to step up enforcement.

For many health care workers, complaining to OSHA is a last resort after failing to get satisfactory responses from supervisors and appealing to unions for help. But with such minimal oversight from OSHA, some union leaders and legislators say it’s actually more dangerous than not having workplace safety enforcement at all. Lack of directives from the Trump administration has left the agency without the teeth it has cut under previous administrations, and recent changes to the agency’s rules raise questions about whether companies are ever required to report workers’ hospitalizations due to COVID-19.

“It’s so ineffective that it’s more dangerous to workers,” said Kim Cordova, president of United Food and Commercial Workers (UFCW) Local 7, which represents 22,000 health care and other workers in Colorado and Wyoming. “Employers only do what they’re forced to do.” Instead of deterring a multi-billion-dollar company, she said, such low fines signal that a company doesn’t need to worry about COVID-related safety.

“OSHA is doing a lamentably poor job protecting workers during the pandemic,” said James Brudney, JD, a professor at Fordham Law School, in New York, and former chief counsel of the U.S. Senate Subcommittee on Labor. “I’m not alone in saying that the agency has performed so badly.”

Former government officials writing in JAMA were similarly critical: “In the face of the greatest worker health crisis in recent history, OSHA, the lead government agency responsible for worker health and safety, has not fulfilled its responsibilities.”
 

What could have been

There were early signs that the agency wouldn’t be heavy-handed about COVID-19 safety concerns, Brudney said.

The agency could have issued Emergency Temporary Standards, rules it can put in place during pandemics that address specific short-term concerns. These rules could have required employers to take infection-control measures to protect workers, including mask wearing, providing proper PPE, and screening for COVID-19 symptoms. “That’s what the agency is supposed to do. They’re supposed to respond to an emergency with emergency measures,” Brudney said.

But despite legislative pressure and a court case, Secretary of Labor Eugene Scalia has declined to do so, saying that the agency would instead rely on its regular general duty clause, which is always in place to keep workplaces free from hazards that “cause death or serious physical harm.” The agency invoked the general duty clause for COVID-19–related violations for the first time in September to levy modest fines.

In response to a request for an interview, a Department of Labor spokesperson said that preexisting OSHA requirements apply to workers during the pandemic, including providing PPE for workers and assessing sanitation and cleanliness standards. The agency has issued specific guidance to companies on pandemic preparedness, she said, and that it responds to all complaints. Additionally, she cited whistleblower laws that make it illegal for employers to retaliate against employees for making safety and health complaints.

The federal OSHA office received 10,868 COVID-related complaints from Feb. 1 through Oct. 20, citing issues ranging from failure to provide proper PPE to not informing workers about exposures. As of Oct. 22, a total of 2,349 of the complaints involved healthcare workers. This count doesn’t include the untold number of “informal” complaints handled by state OSHA offices.

In a recent JAMA opinion piece, two former government officials agreed that “the federal government has not fully utilized OSHA’s public safety authority” and called the issuing of an Emergency Temporary Standard that would require employers to develop and implement infection control plans “the most important action the federal government could take” to protect workers.

“Employers are more likely to implement these controls if they are mandated by a government agency that has adequate enforcement tools to ensure compliance,” wrote former Assistant Secretary of Labor David Michaels, PhD, MPH, now at the Milken Institute School of Public Health of the George Washington University, Washington, and Gregory Wagner, MD, a former senior adviser at the National Institute for Occupational Safety and Health at the Centers for Disease Control and Prevention, now at the Harvard T.H. Chan School of Public Health, Boston.

They cited the success of a standard that OSHA issued in 1991 in response to the HIV/AIDS crisis. “The bloodborne pathogens standard has contributed to a substantial decline in health care worker risk for bloodborne diseases like HIV and hepatitis B and C,” they wrote. In a new report for the Century Foundation, the pair offered recommendations to the federal government for controlling the spread of the disease by ramping up OSHA’s role.

OSHA did issue a response plan that requires employers to report in regard to employees who experienced workplace exposures to SARS-CoV-2 and who were hospitalized with COVID-19 or died of the disease within certain time frames, but recent changes to these rules make experts question whether companies are in fact required to report hospitalizations.

In its second revision of guidelines, added to its FAQ page on Sept. 30, the agency said that, in order to be reportable, “an in-patient hospitalization due to COVID-19 must occur within 24 hours of an exposure to SARS-CoV-2 at work” and that the employer must report the hospitalization within 24 hours of learning both that the employee has been hospitalized and that the reason for the hospitalization was a work-related case of COVID-19. Previously, the 24-hour hospitalization window started at the time of diagnosis of the disease, rather than the work-related exposure.

The agency subsequently dropped the first citation it had issued for a COVID-related violation, even though the company, a nursing home, had already agreed to pay $3,904 for reporting employee hospitalizations late.

“It’s a step backwards from an important workplace and public health function that OSHA should be doing,” said Wagner, coauthor of the JAMA opinion piece.

Even without issuing Emergency Temporary Standards, critics say OSHA could have acted much earlier. OSHA issued its first COVID-related federal citation, the one against the nursing home that was dropped, in May for events that occurred in mid-April. The second COVID-related federal citation came in July.

The agency could also charge much more substantial fines for the citations it has issued. If a medical facility was cited for a PPE violation, such as the Minnesota hospital where workers were told to restaple the elastic bands on N95s, the agency could have cited the hospital for one violation per employee. Such fines based on multiple violations could add up to the hundreds of thousands to millions of dollars.

“It would send a signal to the highest-risk employers that these are violations that need to be addressed immediately,” Brudney said.

Many of the 22 state OSHA offices appear to be more responsive to COVID-related complaints than the federal agency, creating a system in which health care workers have substantially different rights from one state to the next. The governor of California, for example, recently authorized California’s OSHA division to consider COVID-19 an imminent hazard, to prohibit workers from entering areas where the hazard exists, and to require employers to disclose exposures. The state also recently issued large fines for COVID safety issues: $222,075 to frozen food manufacturer Overhill Farms and $214,080 to employment agency Jobsource North America.

Elsewhere, state laws such as New Jersey’s Conscientious Employee Protection Act give workers the right to refuse to work in unsafe situations, Brudney said. “A lot more action is going on at the state level because so little is being done at the federal level,” he said. “Some of it is governors committed to protecting essential workers and their families.”
 

Unions call for sanctions

Unions are both decrying the lack of enforcement thus far and seeking more oversight going forward.

In August, the National Nurses’ United (NNU) union filed a complaint to implore OSHA to investigate the country’s biggest hospital systems, HCA Healthcare, which operates 184 hospitals and about 2,000 other care sites in 21 states and the United Kingdom. The union describes how, throughout HCA hospitals, there is an environment conducive to the spread of coronavirus. Nurses share space and equipment, such as computers, desks, phones, bathrooms, and break rooms, where staff take off masks to eat and drink. The complaint also describes how there is resistance to testing nurses and a lack of communication about infections among colleagues.

“When they have total disregard for safety, they should be punished to the utmost,” said Markowitz, noting that HCA Healthcare is worth $40 billion. “They can penalize them, but if it’s unsafe conditions for RNs and healthcare workers, we know it’s unsafe for the patients. There needs to be drastic measures to prevent hospital corporations from behaving that way.”

In a statement, HCA spokesman Harlow Sumerford said the company has followed CDC guidance for protecting frontline caregivers. “We’re proud of our response and the significant resources we’ve deployed to help protect our colleagues. Meanwhile, the NNU has chosen to use this pandemic as an opportunity to gain publicity by attacking hospitals across the country,” Sumerford said.

Members of the union recently protested in front of the federal OSHA offices in Denver.

After several months, OSHA finally penalized a meat packing plant where eight workers (six union members) had died of COVID-19 last spring. But the amount – $15,615 – was so low that Cordova worries it will actually have a worse impact than no fine.

“It’s more dangerous to workers because now employers know [they won’t be punished meaningfully],” she said. “During the pandemic, OSHA has been absolutely absent.”

Thus, the recent picketing outside the offices in Denver. But, Cordova noted, it’s unlikely OSHA employees saw them. Their own offices were deemed too risky to stay open during the pandemic. They were vacant.
 

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

Last spring, when Cliff Willmeng, RN, was working at United Hospital in St. Paul, Minnesota, he’d take off his personal protective equipment (PPE) in the same hallway where children were transported from ambulances to the neighboring Children’s Hospital emergency department. Stretchers would roll across red tape on the floor that designated the area as a “hot zone.” The door from a break room was about 10 feet away.

Willmeng has been a union activist all his life, but he’d never filed a complaint with the Occupational Safety and Health Administration (OSHA) until the COVID-19 pandemic hit.

Concerned about the inadequate space for doffing PPE and other situations in which the spread of SARS-CoV-2 seemed possible, Willmeng and other colleagues filed multiple OSHA complaints with the Minnesota Department of Labor in March and April. Willmeng was also worried about bringing SARS-CoV-2 on his scrubs home to his wife and kids, and he started wearing hospital-supplied scrubs that were meant for doctors and that were washed on site, which was against hospital policy. The hospital fired Willmeng on May 8, citing code of conduct and respectful workplace violations arising from the uniform dispute.

In August, the state agency issued Willmeng’s hospital a $2,100 fine for failure to comply with guidance regarding “respiratory protection” in response to worker complaints over the fact that they were instructed to restaple elastic bands on N95 masks early in the pandemic. In a statement, United Hospital said it contested the citation, and it is in discussions with Minnesota OSHA. “We have and continue to instruct employees not to alter N95 respirators or reuse damaged or soiled N95 respirators,” such as when the straps are broken, the statement says.

Minnesota OSHA has received three times as many emails and phone calls from workers and employers requesting information and assistance during the pandemic, compared with last year, said spokesperson James Honerman. “If Minnesota OSHA is made aware of a workplace safety or health issue, it assesses the situation and determines how best to respond, including conducting a workplace investigation.”

But Willmeng, who has been out of work since he was fired, says that without a receipt or confirmation from OSHA, he has no way of knowing whether there has been any follow-up regarding his complaints. Minnesota OSHA said workers should receive a letter once a case is resolved.

Like Willmeng’s case, none of the more than 10,000 COVID-related complaints the federal OSHA office has received from across the country have resulted in meaningful sanctions. Unions have picketed local OSHA offices and publicized complaints on behalf of their members to protest what they see as a lack of oversight. Legislators have called on US Department of Labor Secretary Eugene Scalia to step up enforcement.

For many health care workers, complaining to OSHA is a last resort after failing to get satisfactory responses from supervisors and appealing to unions for help. But with such minimal oversight from OSHA, some union leaders and legislators say it’s actually more dangerous than not having workplace safety enforcement at all. Lack of directives from the Trump administration has left the agency without the teeth it has cut under previous administrations, and recent changes to the agency’s rules raise questions about whether companies are ever required to report workers’ hospitalizations due to COVID-19.

“It’s so ineffective that it’s more dangerous to workers,” said Kim Cordova, president of United Food and Commercial Workers (UFCW) Local 7, which represents 22,000 health care and other workers in Colorado and Wyoming. “Employers only do what they’re forced to do.” Instead of deterring a multi-billion-dollar company, she said, such low fines signal that a company doesn’t need to worry about COVID-related safety.

“OSHA is doing a lamentably poor job protecting workers during the pandemic,” said James Brudney, JD, a professor at Fordham Law School, in New York, and former chief counsel of the U.S. Senate Subcommittee on Labor. “I’m not alone in saying that the agency has performed so badly.”

Former government officials writing in JAMA were similarly critical: “In the face of the greatest worker health crisis in recent history, OSHA, the lead government agency responsible for worker health and safety, has not fulfilled its responsibilities.”
 

What could have been

There were early signs that the agency wouldn’t be heavy-handed about COVID-19 safety concerns, Brudney said.

The agency could have issued Emergency Temporary Standards, rules it can put in place during pandemics that address specific short-term concerns. These rules could have required employers to take infection-control measures to protect workers, including mask wearing, providing proper PPE, and screening for COVID-19 symptoms. “That’s what the agency is supposed to do. They’re supposed to respond to an emergency with emergency measures,” Brudney said.

But despite legislative pressure and a court case, Secretary of Labor Eugene Scalia has declined to do so, saying that the agency would instead rely on its regular general duty clause, which is always in place to keep workplaces free from hazards that “cause death or serious physical harm.” The agency invoked the general duty clause for COVID-19–related violations for the first time in September to levy modest fines.

In response to a request for an interview, a Department of Labor spokesperson said that preexisting OSHA requirements apply to workers during the pandemic, including providing PPE for workers and assessing sanitation and cleanliness standards. The agency has issued specific guidance to companies on pandemic preparedness, she said, and that it responds to all complaints. Additionally, she cited whistleblower laws that make it illegal for employers to retaliate against employees for making safety and health complaints.

The federal OSHA office received 10,868 COVID-related complaints from Feb. 1 through Oct. 20, citing issues ranging from failure to provide proper PPE to not informing workers about exposures. As of Oct. 22, a total of 2,349 of the complaints involved healthcare workers. This count doesn’t include the untold number of “informal” complaints handled by state OSHA offices.

In a recent JAMA opinion piece, two former government officials agreed that “the federal government has not fully utilized OSHA’s public safety authority” and called the issuing of an Emergency Temporary Standard that would require employers to develop and implement infection control plans “the most important action the federal government could take” to protect workers.

“Employers are more likely to implement these controls if they are mandated by a government agency that has adequate enforcement tools to ensure compliance,” wrote former Assistant Secretary of Labor David Michaels, PhD, MPH, now at the Milken Institute School of Public Health of the George Washington University, Washington, and Gregory Wagner, MD, a former senior adviser at the National Institute for Occupational Safety and Health at the Centers for Disease Control and Prevention, now at the Harvard T.H. Chan School of Public Health, Boston.

They cited the success of a standard that OSHA issued in 1991 in response to the HIV/AIDS crisis. “The bloodborne pathogens standard has contributed to a substantial decline in health care worker risk for bloodborne diseases like HIV and hepatitis B and C,” they wrote. In a new report for the Century Foundation, the pair offered recommendations to the federal government for controlling the spread of the disease by ramping up OSHA’s role.

OSHA did issue a response plan that requires employers to report in regard to employees who experienced workplace exposures to SARS-CoV-2 and who were hospitalized with COVID-19 or died of the disease within certain time frames, but recent changes to these rules make experts question whether companies are in fact required to report hospitalizations.

In its second revision of guidelines, added to its FAQ page on Sept. 30, the agency said that, in order to be reportable, “an in-patient hospitalization due to COVID-19 must occur within 24 hours of an exposure to SARS-CoV-2 at work” and that the employer must report the hospitalization within 24 hours of learning both that the employee has been hospitalized and that the reason for the hospitalization was a work-related case of COVID-19. Previously, the 24-hour hospitalization window started at the time of diagnosis of the disease, rather than the work-related exposure.

The agency subsequently dropped the first citation it had issued for a COVID-related violation, even though the company, a nursing home, had already agreed to pay $3,904 for reporting employee hospitalizations late.

“It’s a step backwards from an important workplace and public health function that OSHA should be doing,” said Wagner, coauthor of the JAMA opinion piece.

Even without issuing Emergency Temporary Standards, critics say OSHA could have acted much earlier. OSHA issued its first COVID-related federal citation, the one against the nursing home that was dropped, in May for events that occurred in mid-April. The second COVID-related federal citation came in July.

The agency could also charge much more substantial fines for the citations it has issued. If a medical facility was cited for a PPE violation, such as the Minnesota hospital where workers were told to restaple the elastic bands on N95s, the agency could have cited the hospital for one violation per employee. Such fines based on multiple violations could add up to the hundreds of thousands to millions of dollars.

“It would send a signal to the highest-risk employers that these are violations that need to be addressed immediately,” Brudney said.

Many of the 22 state OSHA offices appear to be more responsive to COVID-related complaints than the federal agency, creating a system in which health care workers have substantially different rights from one state to the next. The governor of California, for example, recently authorized California’s OSHA division to consider COVID-19 an imminent hazard, to prohibit workers from entering areas where the hazard exists, and to require employers to disclose exposures. The state also recently issued large fines for COVID safety issues: $222,075 to frozen food manufacturer Overhill Farms and $214,080 to employment agency Jobsource North America.

Elsewhere, state laws such as New Jersey’s Conscientious Employee Protection Act give workers the right to refuse to work in unsafe situations, Brudney said. “A lot more action is going on at the state level because so little is being done at the federal level,” he said. “Some of it is governors committed to protecting essential workers and their families.”
 

Unions call for sanctions

Unions are both decrying the lack of enforcement thus far and seeking more oversight going forward.

In August, the National Nurses’ United (NNU) union filed a complaint to implore OSHA to investigate the country’s biggest hospital systems, HCA Healthcare, which operates 184 hospitals and about 2,000 other care sites in 21 states and the United Kingdom. The union describes how, throughout HCA hospitals, there is an environment conducive to the spread of coronavirus. Nurses share space and equipment, such as computers, desks, phones, bathrooms, and break rooms, where staff take off masks to eat and drink. The complaint also describes how there is resistance to testing nurses and a lack of communication about infections among colleagues.

“When they have total disregard for safety, they should be punished to the utmost,” said Markowitz, noting that HCA Healthcare is worth $40 billion. “They can penalize them, but if it’s unsafe conditions for RNs and healthcare workers, we know it’s unsafe for the patients. There needs to be drastic measures to prevent hospital corporations from behaving that way.”

In a statement, HCA spokesman Harlow Sumerford said the company has followed CDC guidance for protecting frontline caregivers. “We’re proud of our response and the significant resources we’ve deployed to help protect our colleagues. Meanwhile, the NNU has chosen to use this pandemic as an opportunity to gain publicity by attacking hospitals across the country,” Sumerford said.

Members of the union recently protested in front of the federal OSHA offices in Denver.

After several months, OSHA finally penalized a meat packing plant where eight workers (six union members) had died of COVID-19 last spring. But the amount – $15,615 – was so low that Cordova worries it will actually have a worse impact than no fine.

“It’s more dangerous to workers because now employers know [they won’t be punished meaningfully],” she said. “During the pandemic, OSHA has been absolutely absent.”

Thus, the recent picketing outside the offices in Denver. But, Cordova noted, it’s unlikely OSHA employees saw them. Their own offices were deemed too risky to stay open during the pandemic. They were vacant.
 

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

Last spring, when Cliff Willmeng, RN, was working at United Hospital in St. Paul, Minnesota, he’d take off his personal protective equipment (PPE) in the same hallway where children were transported from ambulances to the neighboring Children’s Hospital emergency department. Stretchers would roll across red tape on the floor that designated the area as a “hot zone.” The door from a break room was about 10 feet away.

Willmeng has been a union activist all his life, but he’d never filed a complaint with the Occupational Safety and Health Administration (OSHA) until the COVID-19 pandemic hit.

Concerned about the inadequate space for doffing PPE and other situations in which the spread of SARS-CoV-2 seemed possible, Willmeng and other colleagues filed multiple OSHA complaints with the Minnesota Department of Labor in March and April. Willmeng was also worried about bringing SARS-CoV-2 on his scrubs home to his wife and kids, and he started wearing hospital-supplied scrubs that were meant for doctors and that were washed on site, which was against hospital policy. The hospital fired Willmeng on May 8, citing code of conduct and respectful workplace violations arising from the uniform dispute.

In August, the state agency issued Willmeng’s hospital a $2,100 fine for failure to comply with guidance regarding “respiratory protection” in response to worker complaints over the fact that they were instructed to restaple elastic bands on N95 masks early in the pandemic. In a statement, United Hospital said it contested the citation, and it is in discussions with Minnesota OSHA. “We have and continue to instruct employees not to alter N95 respirators or reuse damaged or soiled N95 respirators,” such as when the straps are broken, the statement says.

Minnesota OSHA has received three times as many emails and phone calls from workers and employers requesting information and assistance during the pandemic, compared with last year, said spokesperson James Honerman. “If Minnesota OSHA is made aware of a workplace safety or health issue, it assesses the situation and determines how best to respond, including conducting a workplace investigation.”

But Willmeng, who has been out of work since he was fired, says that without a receipt or confirmation from OSHA, he has no way of knowing whether there has been any follow-up regarding his complaints. Minnesota OSHA said workers should receive a letter once a case is resolved.

Like Willmeng’s case, none of the more than 10,000 COVID-related complaints the federal OSHA office has received from across the country have resulted in meaningful sanctions. Unions have picketed local OSHA offices and publicized complaints on behalf of their members to protest what they see as a lack of oversight. Legislators have called on US Department of Labor Secretary Eugene Scalia to step up enforcement.

For many health care workers, complaining to OSHA is a last resort after failing to get satisfactory responses from supervisors and appealing to unions for help. But with such minimal oversight from OSHA, some union leaders and legislators say it’s actually more dangerous than not having workplace safety enforcement at all. Lack of directives from the Trump administration has left the agency without the teeth it has cut under previous administrations, and recent changes to the agency’s rules raise questions about whether companies are ever required to report workers’ hospitalizations due to COVID-19.

“It’s so ineffective that it’s more dangerous to workers,” said Kim Cordova, president of United Food and Commercial Workers (UFCW) Local 7, which represents 22,000 health care and other workers in Colorado and Wyoming. “Employers only do what they’re forced to do.” Instead of deterring a multi-billion-dollar company, she said, such low fines signal that a company doesn’t need to worry about COVID-related safety.

“OSHA is doing a lamentably poor job protecting workers during the pandemic,” said James Brudney, JD, a professor at Fordham Law School, in New York, and former chief counsel of the U.S. Senate Subcommittee on Labor. “I’m not alone in saying that the agency has performed so badly.”

Former government officials writing in JAMA were similarly critical: “In the face of the greatest worker health crisis in recent history, OSHA, the lead government agency responsible for worker health and safety, has not fulfilled its responsibilities.”
 

What could have been

There were early signs that the agency wouldn’t be heavy-handed about COVID-19 safety concerns, Brudney said.

The agency could have issued Emergency Temporary Standards, rules it can put in place during pandemics that address specific short-term concerns. These rules could have required employers to take infection-control measures to protect workers, including mask wearing, providing proper PPE, and screening for COVID-19 symptoms. “That’s what the agency is supposed to do. They’re supposed to respond to an emergency with emergency measures,” Brudney said.

But despite legislative pressure and a court case, Secretary of Labor Eugene Scalia has declined to do so, saying that the agency would instead rely on its regular general duty clause, which is always in place to keep workplaces free from hazards that “cause death or serious physical harm.” The agency invoked the general duty clause for COVID-19–related violations for the first time in September to levy modest fines.

In response to a request for an interview, a Department of Labor spokesperson said that preexisting OSHA requirements apply to workers during the pandemic, including providing PPE for workers and assessing sanitation and cleanliness standards. The agency has issued specific guidance to companies on pandemic preparedness, she said, and that it responds to all complaints. Additionally, she cited whistleblower laws that make it illegal for employers to retaliate against employees for making safety and health complaints.

The federal OSHA office received 10,868 COVID-related complaints from Feb. 1 through Oct. 20, citing issues ranging from failure to provide proper PPE to not informing workers about exposures. As of Oct. 22, a total of 2,349 of the complaints involved healthcare workers. This count doesn’t include the untold number of “informal” complaints handled by state OSHA offices.

In a recent JAMA opinion piece, two former government officials agreed that “the federal government has not fully utilized OSHA’s public safety authority” and called the issuing of an Emergency Temporary Standard that would require employers to develop and implement infection control plans “the most important action the federal government could take” to protect workers.

“Employers are more likely to implement these controls if they are mandated by a government agency that has adequate enforcement tools to ensure compliance,” wrote former Assistant Secretary of Labor David Michaels, PhD, MPH, now at the Milken Institute School of Public Health of the George Washington University, Washington, and Gregory Wagner, MD, a former senior adviser at the National Institute for Occupational Safety and Health at the Centers for Disease Control and Prevention, now at the Harvard T.H. Chan School of Public Health, Boston.

They cited the success of a standard that OSHA issued in 1991 in response to the HIV/AIDS crisis. “The bloodborne pathogens standard has contributed to a substantial decline in health care worker risk for bloodborne diseases like HIV and hepatitis B and C,” they wrote. In a new report for the Century Foundation, the pair offered recommendations to the federal government for controlling the spread of the disease by ramping up OSHA’s role.

OSHA did issue a response plan that requires employers to report in regard to employees who experienced workplace exposures to SARS-CoV-2 and who were hospitalized with COVID-19 or died of the disease within certain time frames, but recent changes to these rules make experts question whether companies are in fact required to report hospitalizations.

In its second revision of guidelines, added to its FAQ page on Sept. 30, the agency said that, in order to be reportable, “an in-patient hospitalization due to COVID-19 must occur within 24 hours of an exposure to SARS-CoV-2 at work” and that the employer must report the hospitalization within 24 hours of learning both that the employee has been hospitalized and that the reason for the hospitalization was a work-related case of COVID-19. Previously, the 24-hour hospitalization window started at the time of diagnosis of the disease, rather than the work-related exposure.

The agency subsequently dropped the first citation it had issued for a COVID-related violation, even though the company, a nursing home, had already agreed to pay $3,904 for reporting employee hospitalizations late.

“It’s a step backwards from an important workplace and public health function that OSHA should be doing,” said Wagner, coauthor of the JAMA opinion piece.

Even without issuing Emergency Temporary Standards, critics say OSHA could have acted much earlier. OSHA issued its first COVID-related federal citation, the one against the nursing home that was dropped, in May for events that occurred in mid-April. The second COVID-related federal citation came in July.

The agency could also charge much more substantial fines for the citations it has issued. If a medical facility was cited for a PPE violation, such as the Minnesota hospital where workers were told to restaple the elastic bands on N95s, the agency could have cited the hospital for one violation per employee. Such fines based on multiple violations could add up to the hundreds of thousands to millions of dollars.

“It would send a signal to the highest-risk employers that these are violations that need to be addressed immediately,” Brudney said.

Many of the 22 state OSHA offices appear to be more responsive to COVID-related complaints than the federal agency, creating a system in which health care workers have substantially different rights from one state to the next. The governor of California, for example, recently authorized California’s OSHA division to consider COVID-19 an imminent hazard, to prohibit workers from entering areas where the hazard exists, and to require employers to disclose exposures. The state also recently issued large fines for COVID safety issues: $222,075 to frozen food manufacturer Overhill Farms and $214,080 to employment agency Jobsource North America.

Elsewhere, state laws such as New Jersey’s Conscientious Employee Protection Act give workers the right to refuse to work in unsafe situations, Brudney said. “A lot more action is going on at the state level because so little is being done at the federal level,” he said. “Some of it is governors committed to protecting essential workers and their families.”
 

Unions call for sanctions

Unions are both decrying the lack of enforcement thus far and seeking more oversight going forward.

In August, the National Nurses’ United (NNU) union filed a complaint to implore OSHA to investigate the country’s biggest hospital systems, HCA Healthcare, which operates 184 hospitals and about 2,000 other care sites in 21 states and the United Kingdom. The union describes how, throughout HCA hospitals, there is an environment conducive to the spread of coronavirus. Nurses share space and equipment, such as computers, desks, phones, bathrooms, and break rooms, where staff take off masks to eat and drink. The complaint also describes how there is resistance to testing nurses and a lack of communication about infections among colleagues.

“When they have total disregard for safety, they should be punished to the utmost,” said Markowitz, noting that HCA Healthcare is worth $40 billion. “They can penalize them, but if it’s unsafe conditions for RNs and healthcare workers, we know it’s unsafe for the patients. There needs to be drastic measures to prevent hospital corporations from behaving that way.”

In a statement, HCA spokesman Harlow Sumerford said the company has followed CDC guidance for protecting frontline caregivers. “We’re proud of our response and the significant resources we’ve deployed to help protect our colleagues. Meanwhile, the NNU has chosen to use this pandemic as an opportunity to gain publicity by attacking hospitals across the country,” Sumerford said.

Members of the union recently protested in front of the federal OSHA offices in Denver.

After several months, OSHA finally penalized a meat packing plant where eight workers (six union members) had died of COVID-19 last spring. But the amount – $15,615 – was so low that Cordova worries it will actually have a worse impact than no fine.

“It’s more dangerous to workers because now employers know [they won’t be punished meaningfully],” she said. “During the pandemic, OSHA has been absolutely absent.”

Thus, the recent picketing outside the offices in Denver. But, Cordova noted, it’s unlikely OSHA employees saw them. Their own offices were deemed too risky to stay open during the pandemic. They were vacant.
 

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

COVID-19 cases are surging in rural places across the Mountain States and Midwest, and when it hits health care workers, ready reinforcements aren’t easy to find.

In Montana, pandemic-induced staffing shortages have shuttered a clinic in the state’s capital, led a northwestern regional hospital to ask employees exposed to COVID-19 to continue to work and emptied a health department 400 miles to the east.

“Just one more person out and we wouldn’t be able to keep the surgeries going,” said Dr. Shelly Harkins, MD, chief medical officer of St. Peter’s Health in Helena, a city of roughly 32,000 where cases continue to spread. “When the virus is just all around you, it’s almost impossible to not be deemed a contact at some point. One case can take out a whole team of people in a blink of an eye.”

In North Dakota, where cases per resident are growing faster than any other state, hospitals may once again curtail elective surgeries and possibly seek government aid to hire more nurses if the situation gets worse, North Dakota Hospital Association President Tim Blasl said.

“How long can we run at this rate with the workforce that we have?” Blasl said. “You can have all the licensed beds you want, but if you don’t have anybody to staff those beds, it doesn’t do you any good.”

The northern Rocky Mountains, Great Plains and Upper Midwest are seeing the highest surge of COVID-19 cases in the nation, as some residents have ignored recommendations for curtailing the virus, such as wearing masks and avoiding large gatherings. Montana, Idaho, Utah, Wyoming, North Dakota, South Dakota, Nebraska, Iowa, and Wisconsin have recently ranked among the top 10 U.S. states in confirmed cases per 100,000 residents over a 7-day period, according to an analysis  by the New York Times.

Such coronavirus infections – and the quarantines that occur because of them – are exacerbating the health care worker shortage that existed in these states well before the pandemic. Unlike in the nation’s metropolitan hubs, these outbreaks are scattered across hundreds of miles. And even in these states’ biggest cities, the ranks of medical professionals are in short supply. Specialists and registered nurses are sometimes harder to track down than ventilators, N95 masks or hospital beds. Without enough care providers, patients may not be able to get the medical attention they need.

Hospitals have asked staffers to cover extra shifts and learn new skills. They have brought in temporary workers from other parts of the country and transferred some patients to less-crowded hospitals. But, at St. Peter’s Health, if the hospital’s one kidney doctor gets sick or is told to quarantine, Dr. Harkins doesn’t expect to find a backup.

“We make a point to not have excessive staff because we have an obligation to keep the cost of health care down for a community – we just don’t have a lot of slack in our rope,” Dr. Harkins said. “What we don’t account for is a mass exodus of staff for 14 days.”

Some hospitals are already at patient capacity or are nearly there. That’s not just because of the growing number of COVID-19 patients. Elective surgeries have resumed, and medical emergencies don’t pause for a pandemic.

Some Montana hospitals formed agreements with local affiliates early in the pandemic to share staff if one came up short. But now that the disease is spreading fast – and widely – the hope is that their needs don’t peak all at once.

Montana state officials keep a list of primarily in-state volunteer workers ready to travel to towns with shortages of contact tracers, nurses and more. But during a press conference on Oct. 15, Democratic Gov. Steve Bullock said the state had exhausted that database, and its nationwide request for National Guard medical staffing hadn’t brought in new workers.

“If you are a registered nurse, licensed practical nurse, paramedic, EMT, CNA or contact tracer, and are able to join our workforce, please do consider joining our team,” Gov. Bullock said.

This month, Kalispell Regional Medical Center in northwestern Montana even stopped quarantining COVID-exposed staff who remain asymptomatic, a change allowed by Centers for Disease Control and Prevention guidelines for health facilities facing staffing shortages.

“That’s very telling for what staffing is going through right now,” said Andrea Lueck, a registered nurse at the center. “We’re so tight that employees are called off of quarantine.”

Financial pressure early in the pandemic led the hospital to furlough staff, but it had to bring most of them back to work because it needs those bodies more than ever. The regional hub is based in Flathead County, which has recorded the state’s second-highest number of active COVID-19 cases.

Mellody Sharpton, a hospital spokesperson, said hospital workers who are exposed to someone infected with the virus are tested within three to five days and monitored for symptoms. The hospital is also pulling in new workers, with 25 traveling health professionals on hand and another 25 temporary ones on the way.

But Ms. Sharpton said the best way to conserve the hospital’s workforce is to stop the disease surge in the community.

Earlier in the pandemic, Central Montana Medical Center in Lewistown, a town of fewer than 6,000, experienced an exodus of part-time workers or those close to retirement who decided their jobs weren’t worth the risk. The facility recently secured two traveling workers, but both backed out because they couldn’t find housing. And, so far, roughly 40 of the hospital’s 322 employees have missed work for reasons connected to COVID-19.

“We’re at a critical staffing shortage and have been since the beginning of COVID,” said Joanie Slaybaugh, Central Montana Medical Center’s director of human resources. “We’re small enough, everybody feels an obligation to protect themselves and to protect each other. But it doesn’t take much to take out our staff.”

Roosevelt County, where roughly 11,000 live on the northeastern edge of Montana, had one of the nation’s highest rates of new cases as of Oct. 15. But by the end of the month, the county health department will lose half of its registered nurses as one person is about to retire and another was hired through a grant that’s ending. That leaves only one registered nurse aside from its director, Patty Presser. The health department already had to close earlier during the pandemic because of COVID exposure and not enough staffers to cover the gap. Now, if Ms. Presser can’t find nurse replacements in time, she hopes volunteers will step in, though she added they typically stay for only a few weeks.

“I need someone to do immunizations for my community, and you don’t become an immunization nurse in 14 days,” she said. “We don’t have the workforce here to deal with this virus, not even right now, and then I’m going to have my best two people go.”

Back in Helena, Dr. Harkins said St. Peter’s Health had to close a specialty outpatient clinic that treats chronic diseases for two weeks at the end of September because the entire staff had to quarantine.

Now the hospital is considering having doctors take turns spending a week working from home, so that if another wave of quarantines hits in the hospital, at least one untainted person can be brought back to work. But that won’t help for some specialties, like the hospital’s sole kidney doctor.

Every time Dr. Harkins’ phone rings, she said, she takes a breath and hopes it’s not another case that will force a whole division to close.

“Because I think immediately of the hundreds of people that need that service and won’t have it for 14 days,” she said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

COVID-19 cases are surging in rural places across the Mountain States and Midwest, and when it hits health care workers, ready reinforcements aren’t easy to find.

In Montana, pandemic-induced staffing shortages have shuttered a clinic in the state’s capital, led a northwestern regional hospital to ask employees exposed to COVID-19 to continue to work and emptied a health department 400 miles to the east.

“Just one more person out and we wouldn’t be able to keep the surgeries going,” said Dr. Shelly Harkins, MD, chief medical officer of St. Peter’s Health in Helena, a city of roughly 32,000 where cases continue to spread. “When the virus is just all around you, it’s almost impossible to not be deemed a contact at some point. One case can take out a whole team of people in a blink of an eye.”

In North Dakota, where cases per resident are growing faster than any other state, hospitals may once again curtail elective surgeries and possibly seek government aid to hire more nurses if the situation gets worse, North Dakota Hospital Association President Tim Blasl said.

“How long can we run at this rate with the workforce that we have?” Blasl said. “You can have all the licensed beds you want, but if you don’t have anybody to staff those beds, it doesn’t do you any good.”

The northern Rocky Mountains, Great Plains and Upper Midwest are seeing the highest surge of COVID-19 cases in the nation, as some residents have ignored recommendations for curtailing the virus, such as wearing masks and avoiding large gatherings. Montana, Idaho, Utah, Wyoming, North Dakota, South Dakota, Nebraska, Iowa, and Wisconsin have recently ranked among the top 10 U.S. states in confirmed cases per 100,000 residents over a 7-day period, according to an analysis  by the New York Times.

Such coronavirus infections – and the quarantines that occur because of them – are exacerbating the health care worker shortage that existed in these states well before the pandemic. Unlike in the nation’s metropolitan hubs, these outbreaks are scattered across hundreds of miles. And even in these states’ biggest cities, the ranks of medical professionals are in short supply. Specialists and registered nurses are sometimes harder to track down than ventilators, N95 masks or hospital beds. Without enough care providers, patients may not be able to get the medical attention they need.

Hospitals have asked staffers to cover extra shifts and learn new skills. They have brought in temporary workers from other parts of the country and transferred some patients to less-crowded hospitals. But, at St. Peter’s Health, if the hospital’s one kidney doctor gets sick or is told to quarantine, Dr. Harkins doesn’t expect to find a backup.

“We make a point to not have excessive staff because we have an obligation to keep the cost of health care down for a community – we just don’t have a lot of slack in our rope,” Dr. Harkins said. “What we don’t account for is a mass exodus of staff for 14 days.”

Some hospitals are already at patient capacity or are nearly there. That’s not just because of the growing number of COVID-19 patients. Elective surgeries have resumed, and medical emergencies don’t pause for a pandemic.

Some Montana hospitals formed agreements with local affiliates early in the pandemic to share staff if one came up short. But now that the disease is spreading fast – and widely – the hope is that their needs don’t peak all at once.

Montana state officials keep a list of primarily in-state volunteer workers ready to travel to towns with shortages of contact tracers, nurses and more. But during a press conference on Oct. 15, Democratic Gov. Steve Bullock said the state had exhausted that database, and its nationwide request for National Guard medical staffing hadn’t brought in new workers.

“If you are a registered nurse, licensed practical nurse, paramedic, EMT, CNA or contact tracer, and are able to join our workforce, please do consider joining our team,” Gov. Bullock said.

This month, Kalispell Regional Medical Center in northwestern Montana even stopped quarantining COVID-exposed staff who remain asymptomatic, a change allowed by Centers for Disease Control and Prevention guidelines for health facilities facing staffing shortages.

“That’s very telling for what staffing is going through right now,” said Andrea Lueck, a registered nurse at the center. “We’re so tight that employees are called off of quarantine.”

Financial pressure early in the pandemic led the hospital to furlough staff, but it had to bring most of them back to work because it needs those bodies more than ever. The regional hub is based in Flathead County, which has recorded the state’s second-highest number of active COVID-19 cases.

Mellody Sharpton, a hospital spokesperson, said hospital workers who are exposed to someone infected with the virus are tested within three to five days and monitored for symptoms. The hospital is also pulling in new workers, with 25 traveling health professionals on hand and another 25 temporary ones on the way.

But Ms. Sharpton said the best way to conserve the hospital’s workforce is to stop the disease surge in the community.

Earlier in the pandemic, Central Montana Medical Center in Lewistown, a town of fewer than 6,000, experienced an exodus of part-time workers or those close to retirement who decided their jobs weren’t worth the risk. The facility recently secured two traveling workers, but both backed out because they couldn’t find housing. And, so far, roughly 40 of the hospital’s 322 employees have missed work for reasons connected to COVID-19.

“We’re at a critical staffing shortage and have been since the beginning of COVID,” said Joanie Slaybaugh, Central Montana Medical Center’s director of human resources. “We’re small enough, everybody feels an obligation to protect themselves and to protect each other. But it doesn’t take much to take out our staff.”

Roosevelt County, where roughly 11,000 live on the northeastern edge of Montana, had one of the nation’s highest rates of new cases as of Oct. 15. But by the end of the month, the county health department will lose half of its registered nurses as one person is about to retire and another was hired through a grant that’s ending. That leaves only one registered nurse aside from its director, Patty Presser. The health department already had to close earlier during the pandemic because of COVID exposure and not enough staffers to cover the gap. Now, if Ms. Presser can’t find nurse replacements in time, she hopes volunteers will step in, though she added they typically stay for only a few weeks.

“I need someone to do immunizations for my community, and you don’t become an immunization nurse in 14 days,” she said. “We don’t have the workforce here to deal with this virus, not even right now, and then I’m going to have my best two people go.”

Back in Helena, Dr. Harkins said St. Peter’s Health had to close a specialty outpatient clinic that treats chronic diseases for two weeks at the end of September because the entire staff had to quarantine.

Now the hospital is considering having doctors take turns spending a week working from home, so that if another wave of quarantines hits in the hospital, at least one untainted person can be brought back to work. But that won’t help for some specialties, like the hospital’s sole kidney doctor.

Every time Dr. Harkins’ phone rings, she said, she takes a breath and hopes it’s not another case that will force a whole division to close.

“Because I think immediately of the hundreds of people that need that service and won’t have it for 14 days,” she said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

COVID-19 cases are surging in rural places across the Mountain States and Midwest, and when it hits health care workers, ready reinforcements aren’t easy to find.

In Montana, pandemic-induced staffing shortages have shuttered a clinic in the state’s capital, led a northwestern regional hospital to ask employees exposed to COVID-19 to continue to work and emptied a health department 400 miles to the east.

“Just one more person out and we wouldn’t be able to keep the surgeries going,” said Dr. Shelly Harkins, MD, chief medical officer of St. Peter’s Health in Helena, a city of roughly 32,000 where cases continue to spread. “When the virus is just all around you, it’s almost impossible to not be deemed a contact at some point. One case can take out a whole team of people in a blink of an eye.”

In North Dakota, where cases per resident are growing faster than any other state, hospitals may once again curtail elective surgeries and possibly seek government aid to hire more nurses if the situation gets worse, North Dakota Hospital Association President Tim Blasl said.

“How long can we run at this rate with the workforce that we have?” Blasl said. “You can have all the licensed beds you want, but if you don’t have anybody to staff those beds, it doesn’t do you any good.”

The northern Rocky Mountains, Great Plains and Upper Midwest are seeing the highest surge of COVID-19 cases in the nation, as some residents have ignored recommendations for curtailing the virus, such as wearing masks and avoiding large gatherings. Montana, Idaho, Utah, Wyoming, North Dakota, South Dakota, Nebraska, Iowa, and Wisconsin have recently ranked among the top 10 U.S. states in confirmed cases per 100,000 residents over a 7-day period, according to an analysis  by the New York Times.

Such coronavirus infections – and the quarantines that occur because of them – are exacerbating the health care worker shortage that existed in these states well before the pandemic. Unlike in the nation’s metropolitan hubs, these outbreaks are scattered across hundreds of miles. And even in these states’ biggest cities, the ranks of medical professionals are in short supply. Specialists and registered nurses are sometimes harder to track down than ventilators, N95 masks or hospital beds. Without enough care providers, patients may not be able to get the medical attention they need.

Hospitals have asked staffers to cover extra shifts and learn new skills. They have brought in temporary workers from other parts of the country and transferred some patients to less-crowded hospitals. But, at St. Peter’s Health, if the hospital’s one kidney doctor gets sick or is told to quarantine, Dr. Harkins doesn’t expect to find a backup.

“We make a point to not have excessive staff because we have an obligation to keep the cost of health care down for a community – we just don’t have a lot of slack in our rope,” Dr. Harkins said. “What we don’t account for is a mass exodus of staff for 14 days.”

Some hospitals are already at patient capacity or are nearly there. That’s not just because of the growing number of COVID-19 patients. Elective surgeries have resumed, and medical emergencies don’t pause for a pandemic.

Some Montana hospitals formed agreements with local affiliates early in the pandemic to share staff if one came up short. But now that the disease is spreading fast – and widely – the hope is that their needs don’t peak all at once.

Montana state officials keep a list of primarily in-state volunteer workers ready to travel to towns with shortages of contact tracers, nurses and more. But during a press conference on Oct. 15, Democratic Gov. Steve Bullock said the state had exhausted that database, and its nationwide request for National Guard medical staffing hadn’t brought in new workers.

“If you are a registered nurse, licensed practical nurse, paramedic, EMT, CNA or contact tracer, and are able to join our workforce, please do consider joining our team,” Gov. Bullock said.

This month, Kalispell Regional Medical Center in northwestern Montana even stopped quarantining COVID-exposed staff who remain asymptomatic, a change allowed by Centers for Disease Control and Prevention guidelines for health facilities facing staffing shortages.

“That’s very telling for what staffing is going through right now,” said Andrea Lueck, a registered nurse at the center. “We’re so tight that employees are called off of quarantine.”

Financial pressure early in the pandemic led the hospital to furlough staff, but it had to bring most of them back to work because it needs those bodies more than ever. The regional hub is based in Flathead County, which has recorded the state’s second-highest number of active COVID-19 cases.

Mellody Sharpton, a hospital spokesperson, said hospital workers who are exposed to someone infected with the virus are tested within three to five days and monitored for symptoms. The hospital is also pulling in new workers, with 25 traveling health professionals on hand and another 25 temporary ones on the way.

But Ms. Sharpton said the best way to conserve the hospital’s workforce is to stop the disease surge in the community.

Earlier in the pandemic, Central Montana Medical Center in Lewistown, a town of fewer than 6,000, experienced an exodus of part-time workers or those close to retirement who decided their jobs weren’t worth the risk. The facility recently secured two traveling workers, but both backed out because they couldn’t find housing. And, so far, roughly 40 of the hospital’s 322 employees have missed work for reasons connected to COVID-19.

“We’re at a critical staffing shortage and have been since the beginning of COVID,” said Joanie Slaybaugh, Central Montana Medical Center’s director of human resources. “We’re small enough, everybody feels an obligation to protect themselves and to protect each other. But it doesn’t take much to take out our staff.”

Roosevelt County, where roughly 11,000 live on the northeastern edge of Montana, had one of the nation’s highest rates of new cases as of Oct. 15. But by the end of the month, the county health department will lose half of its registered nurses as one person is about to retire and another was hired through a grant that’s ending. That leaves only one registered nurse aside from its director, Patty Presser. The health department already had to close earlier during the pandemic because of COVID exposure and not enough staffers to cover the gap. Now, if Ms. Presser can’t find nurse replacements in time, she hopes volunteers will step in, though she added they typically stay for only a few weeks.

“I need someone to do immunizations for my community, and you don’t become an immunization nurse in 14 days,” she said. “We don’t have the workforce here to deal with this virus, not even right now, and then I’m going to have my best two people go.”

Back in Helena, Dr. Harkins said St. Peter’s Health had to close a specialty outpatient clinic that treats chronic diseases for two weeks at the end of September because the entire staff had to quarantine.

Now the hospital is considering having doctors take turns spending a week working from home, so that if another wave of quarantines hits in the hospital, at least one untainted person can be brought back to work. But that won’t help for some specialties, like the hospital’s sole kidney doctor.

Every time Dr. Harkins’ phone rings, she said, she takes a breath and hopes it’s not another case that will force a whole division to close.

“Because I think immediately of the hundreds of people that need that service and won’t have it for 14 days,” she said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Improved molecular characterization of mixed glioneuronal and neuronal tumors is driving the World Health Organization to update its classification system for pediatric brain tumors, and that will have far-reaching implications for how clinicians diagnose and manage these rare and often debilitating malignancies, a leading European researcher reported at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year.

“These pediatric neuronal/glioneuronal tumors are quite heterogeneous in terms of the number of different tumors and subclasses of tumors going into these groups, but they have some molecular features in common,” said David T.W. Jones, PhD, of Hopp Children’s Cancer Center in Heidelberg, Germany. “Together they represent quite a sizable portion of all childhood brain tumors, so it’s important to recognize and understand them.”

Dr. Jones noted that updated WHO classifications would add six new descriptions to the category of mixed glioneuronal tumors and one to the list of neuronal tumors. A working group of the Consortium to Inform Molecular and Practical Approaches to CNS Tumor Taxonomy, known as cIMPACT-NOW, has recommended the expanded classifications for central nervous system tumors.

“The molecular understandings of pediatric neuro-glial tumors are critical in their management,” Roger Packer, MD, senior vice president of the Center for Neuroscience and Behavioral Health at Children’s National in Washington, said in an interview, especially as treatments targeting specific molecular structures emerge. “For those with tumors not amenable to safe, total resections, there’s little evidence that radiation or chemotherapy are effective, and molecular-targeted therapy, guided by the molecular genetic composition, increases the safe use of these new agents.”

Dr. Jones noted that “as a minimum” molecular diagnostics of pediatric low-grade glioneuronal and neuronal tumors should include a BRAF gene mutation and fusion status, as well as FGFR1 mutation plus fusion or rearrangement status.

“Ideally,” he added, “it should also have a broader copy number profile, whether that’s based on sequencing or SNP arrays or DNA methylation rate, a global DNA methylation profile to get those global molecular patterns, and also wider gene and RNA sequence to pick up some of those rarer alterations that may not be covered by targeted BRAF and FGFR1 mutations.”

The updated tumor classification will evolve to include novel tumor classes, as well as links or overlaps between the tumor classes and their characteristic underlying kinetic alterations, he noted. “Some of these profiling measures will actually be required to generate a fully WHO-compatible pathological diagnosis,” Dr. Jones said.

“This group of tumors are now just better molecularly characterized than it was 5 years ago, so in the last few years we’ve really made tremendous progress in understanding what alterations are driving some of these tumors,” he said. “That knowledge is now providing a basis for improved diagnosis and also for starting to plan more targeted treatment strategies.”

But, he added, there’s still a lot to learn about how these oncogenic mechanisms drive tumor pathogenesis. “What is the clinical costs when we really start getting down into defining these distinct molecular groups?” he said. “What are their different responses to treatment depending on different levels, where the MEKi [mitogen-activated protein kinase inhibitor] pathway might be activated and, for example, response to treatment of different subclasses of one tumor?”

Large, collaborative clinical studies will be needed to get those answers, he said.

“There are certainly some therapeutic opportunities arising in this group of tumors now, but in order to really translate those into a clinical benefit, we’re really going to need some careful planning of international studies because of the relative rarity of some of these groups,” he said.

Dr. Jones has no relevant financial relationships to disclose.

Improved molecular characterization of mixed glioneuronal and neuronal tumors is driving the World Health Organization to update its classification system for pediatric brain tumors, and that will have far-reaching implications for how clinicians diagnose and manage these rare and often debilitating malignancies, a leading European researcher reported at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year.

“These pediatric neuronal/glioneuronal tumors are quite heterogeneous in terms of the number of different tumors and subclasses of tumors going into these groups, but they have some molecular features in common,” said David T.W. Jones, PhD, of Hopp Children’s Cancer Center in Heidelberg, Germany. “Together they represent quite a sizable portion of all childhood brain tumors, so it’s important to recognize and understand them.”

Dr. Jones noted that updated WHO classifications would add six new descriptions to the category of mixed glioneuronal tumors and one to the list of neuronal tumors. A working group of the Consortium to Inform Molecular and Practical Approaches to CNS Tumor Taxonomy, known as cIMPACT-NOW, has recommended the expanded classifications for central nervous system tumors.

“The molecular understandings of pediatric neuro-glial tumors are critical in their management,” Roger Packer, MD, senior vice president of the Center for Neuroscience and Behavioral Health at Children’s National in Washington, said in an interview, especially as treatments targeting specific molecular structures emerge. “For those with tumors not amenable to safe, total resections, there’s little evidence that radiation or chemotherapy are effective, and molecular-targeted therapy, guided by the molecular genetic composition, increases the safe use of these new agents.”

Dr. Jones noted that “as a minimum” molecular diagnostics of pediatric low-grade glioneuronal and neuronal tumors should include a BRAF gene mutation and fusion status, as well as FGFR1 mutation plus fusion or rearrangement status.

“Ideally,” he added, “it should also have a broader copy number profile, whether that’s based on sequencing or SNP arrays or DNA methylation rate, a global DNA methylation profile to get those global molecular patterns, and also wider gene and RNA sequence to pick up some of those rarer alterations that may not be covered by targeted BRAF and FGFR1 mutations.”

The updated tumor classification will evolve to include novel tumor classes, as well as links or overlaps between the tumor classes and their characteristic underlying kinetic alterations, he noted. “Some of these profiling measures will actually be required to generate a fully WHO-compatible pathological diagnosis,” Dr. Jones said.

“This group of tumors are now just better molecularly characterized than it was 5 years ago, so in the last few years we’ve really made tremendous progress in understanding what alterations are driving some of these tumors,” he said. “That knowledge is now providing a basis for improved diagnosis and also for starting to plan more targeted treatment strategies.”

But, he added, there’s still a lot to learn about how these oncogenic mechanisms drive tumor pathogenesis. “What is the clinical costs when we really start getting down into defining these distinct molecular groups?” he said. “What are their different responses to treatment depending on different levels, where the MEKi [mitogen-activated protein kinase inhibitor] pathway might be activated and, for example, response to treatment of different subclasses of one tumor?”

Large, collaborative clinical studies will be needed to get those answers, he said.

“There are certainly some therapeutic opportunities arising in this group of tumors now, but in order to really translate those into a clinical benefit, we’re really going to need some careful planning of international studies because of the relative rarity of some of these groups,” he said.

Dr. Jones has no relevant financial relationships to disclose.

Improved molecular characterization of mixed glioneuronal and neuronal tumors is driving the World Health Organization to update its classification system for pediatric brain tumors, and that will have far-reaching implications for how clinicians diagnose and manage these rare and often debilitating malignancies, a leading European researcher reported at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year.

“These pediatric neuronal/glioneuronal tumors are quite heterogeneous in terms of the number of different tumors and subclasses of tumors going into these groups, but they have some molecular features in common,” said David T.W. Jones, PhD, of Hopp Children’s Cancer Center in Heidelberg, Germany. “Together they represent quite a sizable portion of all childhood brain tumors, so it’s important to recognize and understand them.”

Dr. Jones noted that updated WHO classifications would add six new descriptions to the category of mixed glioneuronal tumors and one to the list of neuronal tumors. A working group of the Consortium to Inform Molecular and Practical Approaches to CNS Tumor Taxonomy, known as cIMPACT-NOW, has recommended the expanded classifications for central nervous system tumors.

“The molecular understandings of pediatric neuro-glial tumors are critical in their management,” Roger Packer, MD, senior vice president of the Center for Neuroscience and Behavioral Health at Children’s National in Washington, said in an interview, especially as treatments targeting specific molecular structures emerge. “For those with tumors not amenable to safe, total resections, there’s little evidence that radiation or chemotherapy are effective, and molecular-targeted therapy, guided by the molecular genetic composition, increases the safe use of these new agents.”

Dr. Jones noted that “as a minimum” molecular diagnostics of pediatric low-grade glioneuronal and neuronal tumors should include a BRAF gene mutation and fusion status, as well as FGFR1 mutation plus fusion or rearrangement status.

“Ideally,” he added, “it should also have a broader copy number profile, whether that’s based on sequencing or SNP arrays or DNA methylation rate, a global DNA methylation profile to get those global molecular patterns, and also wider gene and RNA sequence to pick up some of those rarer alterations that may not be covered by targeted BRAF and FGFR1 mutations.”

The updated tumor classification will evolve to include novel tumor classes, as well as links or overlaps between the tumor classes and their characteristic underlying kinetic alterations, he noted. “Some of these profiling measures will actually be required to generate a fully WHO-compatible pathological diagnosis,” Dr. Jones said.

“This group of tumors are now just better molecularly characterized than it was 5 years ago, so in the last few years we’ve really made tremendous progress in understanding what alterations are driving some of these tumors,” he said. “That knowledge is now providing a basis for improved diagnosis and also for starting to plan more targeted treatment strategies.”

But, he added, there’s still a lot to learn about how these oncogenic mechanisms drive tumor pathogenesis. “What is the clinical costs when we really start getting down into defining these distinct molecular groups?” he said. “What are their different responses to treatment depending on different levels, where the MEKi [mitogen-activated protein kinase inhibitor] pathway might be activated and, for example, response to treatment of different subclasses of one tumor?”

Large, collaborative clinical studies will be needed to get those answers, he said.

“There are certainly some therapeutic opportunities arising in this group of tumors now, but in order to really translate those into a clinical benefit, we’re really going to need some careful planning of international studies because of the relative rarity of some of these groups,” he said.

Dr. Jones has no relevant financial relationships to disclose.

Acute flaccid myelitis (AFM), a polio-like neuroinfectious disorder, is misdiagnosed in the majority of cases, and that can result in loss of valuable time to admit patients and begin treatment to get ahead of the virus that may cause the disease.

At the 2020 CNS-ICNA Conjoint Meeting, held virtually this year, Leslie H. Hayes, MD, of Boston Children’s Hospital presented findings of a retrospective case series from 13 institutions in the United States and Canada that determined 78% of patients eventually found to have AFM were initially misdiagnosed. About 62% were given an alternate diagnosis or multiple diagnoses, and 60% did not get a referral for further care or evaluation. The study included 175 children aged 18 years and younger when symptoms first appeared from 2014 to 2018 and who met the Centers for Disease Control and Prevention case definition of AFM.

“As it becomes more evident that AFM outbreaks are driven by enterovirus infections, treatments targeting the viral infection are likely to be most effective very early in the course of disease, necessitating a precise and early diagnosis,” Dr. Hayes said. “Thus awareness is needed to help recognize the signs of symptoms of AFM, particularly among frontline clinicians.”

One reason for misdiagnosis is that AFM has features that overlap with other neuroinflammatory disorders, she said. “In many cases the patients are misdiagnosed as having benign or self-limiting processes that would not prompt the same monitoring and level of care.”

Numbness and prodromal illnesses were associated with misdiagnosis, she said, but otherwise most presenting symptoms were similar between the misdiagnosed and correctly diagnosed patients.

Neurologic disorders with similar features to AFM that the study identified were Guillain-Barré syndrome, spinal cord pathologies such as transverse myelitis, brain pathologies including acute disseminating encephalomyelitis, acute inclusion body encephalitis and stroke, and other neuroinflammatory conditions.

“There were also many patients diagnosed as having processes that in many cases would not prompt inpatient admission, would not involve neurology consultation, and would not be treated in a similar fashion to AFM,” Dr. Hayes said.

Those diagnoses included plexopathy, neuritis, Bell’s palsy, meningoencephalitis, nonspecific infectious illness or parainfectious autoimmune disease, or musculoskeletal problems including toxic or transient synovitis, myositis, fracture or sprain, or torticollis.

“We identified preceding illness and numbness as two features associated with misdiagnosis,” Dr. Hayes said.

“We evaluated illness severity by evaluating the need for invasive and noninvasive ventilation and found that, while not statistically significant, misdiagnosed patients had a trend toward higher need for such respiratory support,” she noted. Specifically, 31.6% of misdiagnosed patients required noninvasive ventilation versus 15.8% of promptly diagnosed patients (P = .06).

Dr. Hayes characterized the rates of ICU admissions between the two groups as not statistically significant: 52.5% and 36.8% for the misdiagnosed and promptly diagnosed groups, respectively (P = .1).

Both groups of patients received intravenous immunoglobulin in similar rates (77.9% and 81.6%, respectively, P = .63), but the misdiagnosed patients were much more likely to receive steroids, 68.2% versus 44.7% (P = .008). That’s likely because steroids are the standard treatment for the neuroinflammatory disorders that they were misdiagnosed with, Dr. Hayes said.

Timely diagnosis and treatment was more of an issue for the misdiagnosed patients; their diagnosis was made on average 5 days after the onset of symptoms versus 3 days (P < .001). “We found that time to treatment, particularly time to IVIg, was significantly longer in the misdiagnosed group,” Dr. Hayes said, at 5 versus 2 days (P < .001).

Dr. Hayes has no relevant financial relationships to disclose.

Acute flaccid myelitis (AFM), a polio-like neuroinfectious disorder, is misdiagnosed in the majority of cases, and that can result in loss of valuable time to admit patients and begin treatment to get ahead of the virus that may cause the disease.

At the 2020 CNS-ICNA Conjoint Meeting, held virtually this year, Leslie H. Hayes, MD, of Boston Children’s Hospital presented findings of a retrospective case series from 13 institutions in the United States and Canada that determined 78% of patients eventually found to have AFM were initially misdiagnosed. About 62% were given an alternate diagnosis or multiple diagnoses, and 60% did not get a referral for further care or evaluation. The study included 175 children aged 18 years and younger when symptoms first appeared from 2014 to 2018 and who met the Centers for Disease Control and Prevention case definition of AFM.

“As it becomes more evident that AFM outbreaks are driven by enterovirus infections, treatments targeting the viral infection are likely to be most effective very early in the course of disease, necessitating a precise and early diagnosis,” Dr. Hayes said. “Thus awareness is needed to help recognize the signs of symptoms of AFM, particularly among frontline clinicians.”

One reason for misdiagnosis is that AFM has features that overlap with other neuroinflammatory disorders, she said. “In many cases the patients are misdiagnosed as having benign or self-limiting processes that would not prompt the same monitoring and level of care.”

Numbness and prodromal illnesses were associated with misdiagnosis, she said, but otherwise most presenting symptoms were similar between the misdiagnosed and correctly diagnosed patients.

Neurologic disorders with similar features to AFM that the study identified were Guillain-Barré syndrome, spinal cord pathologies such as transverse myelitis, brain pathologies including acute disseminating encephalomyelitis, acute inclusion body encephalitis and stroke, and other neuroinflammatory conditions.

“There were also many patients diagnosed as having processes that in many cases would not prompt inpatient admission, would not involve neurology consultation, and would not be treated in a similar fashion to AFM,” Dr. Hayes said.

Those diagnoses included plexopathy, neuritis, Bell’s palsy, meningoencephalitis, nonspecific infectious illness or parainfectious autoimmune disease, or musculoskeletal problems including toxic or transient synovitis, myositis, fracture or sprain, or torticollis.

“We identified preceding illness and numbness as two features associated with misdiagnosis,” Dr. Hayes said.

“We evaluated illness severity by evaluating the need for invasive and noninvasive ventilation and found that, while not statistically significant, misdiagnosed patients had a trend toward higher need for such respiratory support,” she noted. Specifically, 31.6% of misdiagnosed patients required noninvasive ventilation versus 15.8% of promptly diagnosed patients (P = .06).

Dr. Hayes characterized the rates of ICU admissions between the two groups as not statistically significant: 52.5% and 36.8% for the misdiagnosed and promptly diagnosed groups, respectively (P = .1).

Both groups of patients received intravenous immunoglobulin in similar rates (77.9% and 81.6%, respectively, P = .63), but the misdiagnosed patients were much more likely to receive steroids, 68.2% versus 44.7% (P = .008). That’s likely because steroids are the standard treatment for the neuroinflammatory disorders that they were misdiagnosed with, Dr. Hayes said.

Timely diagnosis and treatment was more of an issue for the misdiagnosed patients; their diagnosis was made on average 5 days after the onset of symptoms versus 3 days (P < .001). “We found that time to treatment, particularly time to IVIg, was significantly longer in the misdiagnosed group,” Dr. Hayes said, at 5 versus 2 days (P < .001).

Dr. Hayes has no relevant financial relationships to disclose.

Acute flaccid myelitis (AFM), a polio-like neuroinfectious disorder, is misdiagnosed in the majority of cases, and that can result in loss of valuable time to admit patients and begin treatment to get ahead of the virus that may cause the disease.

At the 2020 CNS-ICNA Conjoint Meeting, held virtually this year, Leslie H. Hayes, MD, of Boston Children’s Hospital presented findings of a retrospective case series from 13 institutions in the United States and Canada that determined 78% of patients eventually found to have AFM were initially misdiagnosed. About 62% were given an alternate diagnosis or multiple diagnoses, and 60% did not get a referral for further care or evaluation. The study included 175 children aged 18 years and younger when symptoms first appeared from 2014 to 2018 and who met the Centers for Disease Control and Prevention case definition of AFM.

“As it becomes more evident that AFM outbreaks are driven by enterovirus infections, treatments targeting the viral infection are likely to be most effective very early in the course of disease, necessitating a precise and early diagnosis,” Dr. Hayes said. “Thus awareness is needed to help recognize the signs of symptoms of AFM, particularly among frontline clinicians.”

One reason for misdiagnosis is that AFM has features that overlap with other neuroinflammatory disorders, she said. “In many cases the patients are misdiagnosed as having benign or self-limiting processes that would not prompt the same monitoring and level of care.”

Numbness and prodromal illnesses were associated with misdiagnosis, she said, but otherwise most presenting symptoms were similar between the misdiagnosed and correctly diagnosed patients.

Neurologic disorders with similar features to AFM that the study identified were Guillain-Barré syndrome, spinal cord pathologies such as transverse myelitis, brain pathologies including acute disseminating encephalomyelitis, acute inclusion body encephalitis and stroke, and other neuroinflammatory conditions.

“There were also many patients diagnosed as having processes that in many cases would not prompt inpatient admission, would not involve neurology consultation, and would not be treated in a similar fashion to AFM,” Dr. Hayes said.

Those diagnoses included plexopathy, neuritis, Bell’s palsy, meningoencephalitis, nonspecific infectious illness or parainfectious autoimmune disease, or musculoskeletal problems including toxic or transient synovitis, myositis, fracture or sprain, or torticollis.

“We identified preceding illness and numbness as two features associated with misdiagnosis,” Dr. Hayes said.

“We evaluated illness severity by evaluating the need for invasive and noninvasive ventilation and found that, while not statistically significant, misdiagnosed patients had a trend toward higher need for such respiratory support,” she noted. Specifically, 31.6% of misdiagnosed patients required noninvasive ventilation versus 15.8% of promptly diagnosed patients (P = .06).

Dr. Hayes characterized the rates of ICU admissions between the two groups as not statistically significant: 52.5% and 36.8% for the misdiagnosed and promptly diagnosed groups, respectively (P = .1).

Both groups of patients received intravenous immunoglobulin in similar rates (77.9% and 81.6%, respectively, P = .63), but the misdiagnosed patients were much more likely to receive steroids, 68.2% versus 44.7% (P = .008). That’s likely because steroids are the standard treatment for the neuroinflammatory disorders that they were misdiagnosed with, Dr. Hayes said.

Timely diagnosis and treatment was more of an issue for the misdiagnosed patients; their diagnosis was made on average 5 days after the onset of symptoms versus 3 days (P < .001). “We found that time to treatment, particularly time to IVIg, was significantly longer in the misdiagnosed group,” Dr. Hayes said, at 5 versus 2 days (P < .001).

Dr. Hayes has no relevant financial relationships to disclose.