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COVID-19 in kids: Severe illness most common in infants, teens
Children and young adults in all age groups can develop severe illness after SARS-CoV-2 infection, but the oldest and youngest appear most likely to be hospitalized and possibly critically ill, based on data from a retrospective cohort study of 177 pediatric patients seen at a single center.
“Although children and young adults clearly are susceptible to SARS-CoV-2 infection, attention has focused primarily on their potential role in influencing spread and community transmission rather than the potential severity of infection in children and young adults themselves,” wrote Roberta L. DeBiasi, MD, chief of the division of pediatric infectious diseases at Children’s National Hospital, Washington, and colleagues.
In a study published in the Journal of Pediatrics, the researchers reviewed data from 44 hospitalized and 133 non-hospitalized children and young adults infected with SARS-CoV-2. Of the 44 hospitalized patients, 35 were noncritically ill and 9 were critically ill. The study population ranged from 0.1-34 years of age, with a median of 10 years, which was similar between hospitalized and nonhospitalized patients. However, the median age of critically ill patients was significantly higher, compared with noncritically ill patients (17 years vs. 4 years). All age groups were represented in all cohorts. “However, we noted a bimodal distribution of patients less than 1 year of age and patients greater than 15 years of age representing the largest proportion of patients within the SARS-CoV-2–infected hospitalized and critically ill cohorts,” the researchers noted. Children less than 1 year and adolescents/young adults over 15 years each represented 32% of the 44 hospitalized patients.
Overall, 39% of the 177 patients had underlying medical conditions, the most frequent of which was asthma (20%), which was not significantly more common between hospitalized/nonhospitalized patients or critically ill/noncritically ill patients. Patients also presented with neurologic conditions (6%), diabetes (3%), obesity (2%), cardiac conditions (3%), hematologic conditions (3%) and oncologic conditions (1%). Underlying conditions occurred more commonly in the hospitalized cohort (63%) than in the nonhospitalized cohort (32%).
Neurologic disorders, cardiac conditions, hematologic conditions, and oncologic conditions were significantly more common in hospitalized patients, but not significantly more common among those critically ill versus noncritically ill.
About 76% of the patients presented with respiratory symptoms including rhinorrhea, congestion, sore throat, cough, or shortness of breath – with or without fever; 66% had fevers; and 48% had both respiratory symptoms and fever. Shortness of breath was significantly more common among hospitalized patients versus nonhospitalized patients (26% vs. 12%), but less severe respiratory symptoms were significantly more common among nonhospitalized patients, the researchers noted.
Other symptoms – such as diarrhea, vomiting, chest pain, and loss of sense or smell occurred in a small percentage of patients – but were not more likely to occur in any of the cohorts.
Among the critically ill patients, eight of nine needed some level of respiratory support, and four were on ventilators.
“One patient had features consistent with the recently emerged Kawasaki disease–like presentation with hyperinflammatory state, hypotension, and profound myocardial depression,” Dr. DiBiasi and associates noted.
The researchers found coinfection with routine coronavirus, respiratory syncytial virus, or rhinovirus/enterovirus in 4 of 63 (6%) patients, but the clinical impact of these coinfections are unclear.
The study findings were limited by several factors including the retrospective design and the ongoing transmission of COVID-19 in the Washington area, the researchers noted. “One potential bias of this study is our regional role in providing critical care for young adults age 21-35 years with COVID-19.” In addition, “we plan to address the role of race and ethnicity after validation of current administrative data and have elected to defer this analysis until completed.”
“Our findings highlight the potential for severe disease in this age group and inform other regions to anticipate and prepare their COVID-19 response to include a significant burden of hospitalized and critically ill children and young adults. As SARS-CoV-2 spreads within the United States, regional differences may be apparent based on virus and host factors that are yet to be identified,” Dr. DeBiasi and colleagues concluded.
Robin Steinhorn, MD, serves as an associate editor for the Journal of Pediatrics. The other researchers declared no conflicts of interest.
SOURCE: DeBiasi RL et al. J Pediatr. 2020 May 6. doi: 10.1016/j.jpeds.2020.05.007.
This article was updated 5/19/20.
Children and young adults in all age groups can develop severe illness after SARS-CoV-2 infection, but the oldest and youngest appear most likely to be hospitalized and possibly critically ill, based on data from a retrospective cohort study of 177 pediatric patients seen at a single center.
“Although children and young adults clearly are susceptible to SARS-CoV-2 infection, attention has focused primarily on their potential role in influencing spread and community transmission rather than the potential severity of infection in children and young adults themselves,” wrote Roberta L. DeBiasi, MD, chief of the division of pediatric infectious diseases at Children’s National Hospital, Washington, and colleagues.
In a study published in the Journal of Pediatrics, the researchers reviewed data from 44 hospitalized and 133 non-hospitalized children and young adults infected with SARS-CoV-2. Of the 44 hospitalized patients, 35 were noncritically ill and 9 were critically ill. The study population ranged from 0.1-34 years of age, with a median of 10 years, which was similar between hospitalized and nonhospitalized patients. However, the median age of critically ill patients was significantly higher, compared with noncritically ill patients (17 years vs. 4 years). All age groups were represented in all cohorts. “However, we noted a bimodal distribution of patients less than 1 year of age and patients greater than 15 years of age representing the largest proportion of patients within the SARS-CoV-2–infected hospitalized and critically ill cohorts,” the researchers noted. Children less than 1 year and adolescents/young adults over 15 years each represented 32% of the 44 hospitalized patients.
Overall, 39% of the 177 patients had underlying medical conditions, the most frequent of which was asthma (20%), which was not significantly more common between hospitalized/nonhospitalized patients or critically ill/noncritically ill patients. Patients also presented with neurologic conditions (6%), diabetes (3%), obesity (2%), cardiac conditions (3%), hematologic conditions (3%) and oncologic conditions (1%). Underlying conditions occurred more commonly in the hospitalized cohort (63%) than in the nonhospitalized cohort (32%).
Neurologic disorders, cardiac conditions, hematologic conditions, and oncologic conditions were significantly more common in hospitalized patients, but not significantly more common among those critically ill versus noncritically ill.
About 76% of the patients presented with respiratory symptoms including rhinorrhea, congestion, sore throat, cough, or shortness of breath – with or without fever; 66% had fevers; and 48% had both respiratory symptoms and fever. Shortness of breath was significantly more common among hospitalized patients versus nonhospitalized patients (26% vs. 12%), but less severe respiratory symptoms were significantly more common among nonhospitalized patients, the researchers noted.
Other symptoms – such as diarrhea, vomiting, chest pain, and loss of sense or smell occurred in a small percentage of patients – but were not more likely to occur in any of the cohorts.
Among the critically ill patients, eight of nine needed some level of respiratory support, and four were on ventilators.
“One patient had features consistent with the recently emerged Kawasaki disease–like presentation with hyperinflammatory state, hypotension, and profound myocardial depression,” Dr. DiBiasi and associates noted.
The researchers found coinfection with routine coronavirus, respiratory syncytial virus, or rhinovirus/enterovirus in 4 of 63 (6%) patients, but the clinical impact of these coinfections are unclear.
The study findings were limited by several factors including the retrospective design and the ongoing transmission of COVID-19 in the Washington area, the researchers noted. “One potential bias of this study is our regional role in providing critical care for young adults age 21-35 years with COVID-19.” In addition, “we plan to address the role of race and ethnicity after validation of current administrative data and have elected to defer this analysis until completed.”
“Our findings highlight the potential for severe disease in this age group and inform other regions to anticipate and prepare their COVID-19 response to include a significant burden of hospitalized and critically ill children and young adults. As SARS-CoV-2 spreads within the United States, regional differences may be apparent based on virus and host factors that are yet to be identified,” Dr. DeBiasi and colleagues concluded.
Robin Steinhorn, MD, serves as an associate editor for the Journal of Pediatrics. The other researchers declared no conflicts of interest.
SOURCE: DeBiasi RL et al. J Pediatr. 2020 May 6. doi: 10.1016/j.jpeds.2020.05.007.
This article was updated 5/19/20.
Children and young adults in all age groups can develop severe illness after SARS-CoV-2 infection, but the oldest and youngest appear most likely to be hospitalized and possibly critically ill, based on data from a retrospective cohort study of 177 pediatric patients seen at a single center.
“Although children and young adults clearly are susceptible to SARS-CoV-2 infection, attention has focused primarily on their potential role in influencing spread and community transmission rather than the potential severity of infection in children and young adults themselves,” wrote Roberta L. DeBiasi, MD, chief of the division of pediatric infectious diseases at Children’s National Hospital, Washington, and colleagues.
In a study published in the Journal of Pediatrics, the researchers reviewed data from 44 hospitalized and 133 non-hospitalized children and young adults infected with SARS-CoV-2. Of the 44 hospitalized patients, 35 were noncritically ill and 9 were critically ill. The study population ranged from 0.1-34 years of age, with a median of 10 years, which was similar between hospitalized and nonhospitalized patients. However, the median age of critically ill patients was significantly higher, compared with noncritically ill patients (17 years vs. 4 years). All age groups were represented in all cohorts. “However, we noted a bimodal distribution of patients less than 1 year of age and patients greater than 15 years of age representing the largest proportion of patients within the SARS-CoV-2–infected hospitalized and critically ill cohorts,” the researchers noted. Children less than 1 year and adolescents/young adults over 15 years each represented 32% of the 44 hospitalized patients.
Overall, 39% of the 177 patients had underlying medical conditions, the most frequent of which was asthma (20%), which was not significantly more common between hospitalized/nonhospitalized patients or critically ill/noncritically ill patients. Patients also presented with neurologic conditions (6%), diabetes (3%), obesity (2%), cardiac conditions (3%), hematologic conditions (3%) and oncologic conditions (1%). Underlying conditions occurred more commonly in the hospitalized cohort (63%) than in the nonhospitalized cohort (32%).
Neurologic disorders, cardiac conditions, hematologic conditions, and oncologic conditions were significantly more common in hospitalized patients, but not significantly more common among those critically ill versus noncritically ill.
About 76% of the patients presented with respiratory symptoms including rhinorrhea, congestion, sore throat, cough, or shortness of breath – with or without fever; 66% had fevers; and 48% had both respiratory symptoms and fever. Shortness of breath was significantly more common among hospitalized patients versus nonhospitalized patients (26% vs. 12%), but less severe respiratory symptoms were significantly more common among nonhospitalized patients, the researchers noted.
Other symptoms – such as diarrhea, vomiting, chest pain, and loss of sense or smell occurred in a small percentage of patients – but were not more likely to occur in any of the cohorts.
Among the critically ill patients, eight of nine needed some level of respiratory support, and four were on ventilators.
“One patient had features consistent with the recently emerged Kawasaki disease–like presentation with hyperinflammatory state, hypotension, and profound myocardial depression,” Dr. DiBiasi and associates noted.
The researchers found coinfection with routine coronavirus, respiratory syncytial virus, or rhinovirus/enterovirus in 4 of 63 (6%) patients, but the clinical impact of these coinfections are unclear.
The study findings were limited by several factors including the retrospective design and the ongoing transmission of COVID-19 in the Washington area, the researchers noted. “One potential bias of this study is our regional role in providing critical care for young adults age 21-35 years with COVID-19.” In addition, “we plan to address the role of race and ethnicity after validation of current administrative data and have elected to defer this analysis until completed.”
“Our findings highlight the potential for severe disease in this age group and inform other regions to anticipate and prepare their COVID-19 response to include a significant burden of hospitalized and critically ill children and young adults. As SARS-CoV-2 spreads within the United States, regional differences may be apparent based on virus and host factors that are yet to be identified,” Dr. DeBiasi and colleagues concluded.
Robin Steinhorn, MD, serves as an associate editor for the Journal of Pediatrics. The other researchers declared no conflicts of interest.
SOURCE: DeBiasi RL et al. J Pediatr. 2020 May 6. doi: 10.1016/j.jpeds.2020.05.007.
This article was updated 5/19/20.
FROM THE JOURNAL OF PEDIATRICS
Modify risk factors to manage ICU delirium in patients with COVID-19
, and a bedside risk management strategy based on modifiable risk factors can help prevent lingering effects on cognition, according to an article published in Critical Care.
Several factors can contribute to an increased risk of ICU delirium in COVID-19 patients, wrote Katarzyna Kotfis, MD, of Pomeranian Medical University, Szczecin, Poland, and colleagues.
“In patients with COVID-19, delirium may be a manifestation of direct central nervous system invasion, induction of CNS inflammatory mediators, a secondary effect of other organ system failure, an effect of sedative strategies, prolonged mechanical ventilation time, or environmental factors, including social isolation,” they said.
Delirium in the context of COVID-19 can mean an early sign of infection, so patients should be screened using dedicated psychometric tools, the researchers wrote. Also, COVID-19 has been shown to cause pneumonia in elderly patients, who are at high risk for severe pulmonary disease related to COVID-19 and for ICU delirium generally, they said.
In addition, don’t underestimate the impact of social isolation created by quarantines, the researchers said.
“What is needed now, is not only high-quality ICU care, concentrated on providing adequate respiratory support to critically ill patients, but an identification of the source and degree of mental and spiritual suffering of patients as well as their families to provide the most ethical and person-centered care during this humanitarian crisis,” they emphasized. However, they acknowledged that nonpharmacologic interventions such as mobility outside the ICU room and interactions with family members are limited by the COVID-19 situation.
The researchers noted several mechanisms by which the COVID-19 virus may cause brain damage, including through the dysfunction of the renin-angiotensin system.
“Inflammatory response of the CNS to viral infection seems to be another important reason for poor neurological outcome and occurrence of delirium,” in COVID-19 patients, they said.
As for risk-reduction strategies, the researchers noted that “delirium in mechanically ventilated patients can be reduced dramatically to 50% using a culture of lighter sedation and mobilization via the implementation of the safety bundle called the ABCDEFs promoted by the Society of Critical Care Medicine in their ICU Liberation Collaborative,” although COVID-19 isolation is a barrier, they said.
The ABCDEF bundle consists of Assessment of pain, Both spontaneous awakening trials and spontaneous breathing trials, Choice of sedation, Delirium (hyperactive or hypoactive), Early mobility, and Family presence; all of which are challenging in the COVID-19 environment, the researchers said.
They advised implementing easy screening methods for delirium to reduce the burden on medical staff, and emphasized the importance of regular patient orientation, despite social separation from family and caregivers.
“No drugs can be recommended for the prevention or treatment of ICU delirium other than avoidance of overuse of potent psychoactive agents like sedatives and neuromuscular blockers (NMB) unless patients absolutely require such management,” they added.
“Delirium is so common and so hard to manage in the COVID-19 population,” Mangala Narasimhan, DO, of Northwell Health in New Hyde Park, N.Y., said in an interview. Delirium is impacted by many sources including a viral encephalopathy, the amount and duration of sedation medications, and prolonged intubation and hypoxemia, she said. “Managing the delirium allows you to wake the patient up successfully and without a lot of discoordination. This will help with weaning,” she noted. Barriers to delirium management for COVID-19 patients include the length of time on a ventilator, as well as amount of sedatives and paralytics, and the added issues of renal insufficiency, she noted. “How they can be addressed is thoughtful plans on the addition of long-term sedation for withdrawal symptoms, and anxiolytics for the profound anxiety associated with arousal from this type of sedation on ventilators, she said. The take-home message for clinicians is the need to perform weaning trials to manage delirium in the ICU. “We have to combat this delirium in order to be successful in taking these patients off of ventilators,” she said. Dr. Narasimhan added that more research is needed on areas including drug-to-drug interactions, duration of efficacy of various drugs, and how the virus affects the brain.
“Adherence to the ABCDEF bundle can reduce the incidence of delirium, from approximately 75% of mechanically ventilated patients to 50% or less,” David L. Bowton, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., said in an interview.
“Importantly, in most studies, bundle adherence reduces mortality and ICU length of stay and lowers the total cost of care. However, isolation of patients and protection of staff, visitor restrictions, and potentially stressed staffing will likely alter how most institutions approach bundle compliance,” he said. “Gathering input from infection control clinicians and bedside providers from multiple disciplines that consider these factors to critically examine current bundle procedures and workflow will be essential to the creation and/or revision of bundle processes of care that maintain the integrity of the ABCDEF bundle yet preserve staff, patient, and family safety,” he said.
“We did not have strong evidence to suggest an optimal approach to treating delirium before the advent of the COVID-19 pandemic, so I do not believe we know what the best approach is in the current environment,” Dr. Bowton added. “Further, vigilance will be necessary to ensure that altered consciousness or cognition is ICU delirium and not attributable to another cause such as drug withdrawal, drug adverse effect, or primary central nervous system infection or immune response that mandates specific therapy,” he emphasized.
For clinicians, “this study reminds us of the importance of the ABCDEF bundle to improve outcomes of critical illness,” said Dr. Bowton. “It highlights the difficulties of providing frequent reassessment of pain, comfort, reassurance, and reorientation to critically ill patients. To me, it underscores the importance of each institution critically examining staffing needs and staffing roles to mitigate these difficulties and to explore novel methods of maintaining staff-patient and family-patient interactions to enhance compliance with all elements of the ABCDEF bundle while maintaining the safety of staff and families.”
Dr. Bowton added, “When necessary, explicit modifications to existing ABCDEF bundles should be developed and disseminated to provide realistic, readily understood guidance to achieve the best possible compliance with each bundle element. One potentially underrecognized issue will be the large, hopefully temporary, number of people requiring post–critical illness rehabilitation and mental health services,” he said. “In many regions these services are already underfunded and ill-equipped to handle an increased demand for these services,” he noted.
Additional research is needed in many areas, said Dr. Bowton. “While compliance with the ABCDEF bundle decreases the incidence and duration of delirium, decreases ICU length of stay, decreases duration of mechanical ventilation, and improves mortality, many questions remain. Individual elements of the bundle have been inconsistently associated with improved outcomes,” he said. “What is the relative importance of specific elements and what are the mechanisms by which they improve outcomes?” he asked. “We still do not know how to best achieve physical/functional recovery following critical illness, which, in light of these authors’ studies relating persisting physical debility to depression (Lancet Respir Med. 2014; 2[5]:369-79), may be a key component to improving long-term outcomes,” he said.
The study received no specific funding, although several coauthors disclosed grants from agencies including the National Center for Advancing Translational Sciences, National Institute of General Medical Sciences, National Heart, Lung, and Blood Institute, and National Institute on Aging. Dr. Narasimhan and Dr. Bowton had no financial conflicts to disclose.
SOURCE: Kotfis K et al. Critical Care. 2020 Apr 28. doi: 10.1186/s13054-020-02882-x.
, and a bedside risk management strategy based on modifiable risk factors can help prevent lingering effects on cognition, according to an article published in Critical Care.
Several factors can contribute to an increased risk of ICU delirium in COVID-19 patients, wrote Katarzyna Kotfis, MD, of Pomeranian Medical University, Szczecin, Poland, and colleagues.
“In patients with COVID-19, delirium may be a manifestation of direct central nervous system invasion, induction of CNS inflammatory mediators, a secondary effect of other organ system failure, an effect of sedative strategies, prolonged mechanical ventilation time, or environmental factors, including social isolation,” they said.
Delirium in the context of COVID-19 can mean an early sign of infection, so patients should be screened using dedicated psychometric tools, the researchers wrote. Also, COVID-19 has been shown to cause pneumonia in elderly patients, who are at high risk for severe pulmonary disease related to COVID-19 and for ICU delirium generally, they said.
In addition, don’t underestimate the impact of social isolation created by quarantines, the researchers said.
“What is needed now, is not only high-quality ICU care, concentrated on providing adequate respiratory support to critically ill patients, but an identification of the source and degree of mental and spiritual suffering of patients as well as their families to provide the most ethical and person-centered care during this humanitarian crisis,” they emphasized. However, they acknowledged that nonpharmacologic interventions such as mobility outside the ICU room and interactions with family members are limited by the COVID-19 situation.
The researchers noted several mechanisms by which the COVID-19 virus may cause brain damage, including through the dysfunction of the renin-angiotensin system.
“Inflammatory response of the CNS to viral infection seems to be another important reason for poor neurological outcome and occurrence of delirium,” in COVID-19 patients, they said.
As for risk-reduction strategies, the researchers noted that “delirium in mechanically ventilated patients can be reduced dramatically to 50% using a culture of lighter sedation and mobilization via the implementation of the safety bundle called the ABCDEFs promoted by the Society of Critical Care Medicine in their ICU Liberation Collaborative,” although COVID-19 isolation is a barrier, they said.
The ABCDEF bundle consists of Assessment of pain, Both spontaneous awakening trials and spontaneous breathing trials, Choice of sedation, Delirium (hyperactive or hypoactive), Early mobility, and Family presence; all of which are challenging in the COVID-19 environment, the researchers said.
They advised implementing easy screening methods for delirium to reduce the burden on medical staff, and emphasized the importance of regular patient orientation, despite social separation from family and caregivers.
“No drugs can be recommended for the prevention or treatment of ICU delirium other than avoidance of overuse of potent psychoactive agents like sedatives and neuromuscular blockers (NMB) unless patients absolutely require such management,” they added.
“Delirium is so common and so hard to manage in the COVID-19 population,” Mangala Narasimhan, DO, of Northwell Health in New Hyde Park, N.Y., said in an interview. Delirium is impacted by many sources including a viral encephalopathy, the amount and duration of sedation medications, and prolonged intubation and hypoxemia, she said. “Managing the delirium allows you to wake the patient up successfully and without a lot of discoordination. This will help with weaning,” she noted. Barriers to delirium management for COVID-19 patients include the length of time on a ventilator, as well as amount of sedatives and paralytics, and the added issues of renal insufficiency, she noted. “How they can be addressed is thoughtful plans on the addition of long-term sedation for withdrawal symptoms, and anxiolytics for the profound anxiety associated with arousal from this type of sedation on ventilators, she said. The take-home message for clinicians is the need to perform weaning trials to manage delirium in the ICU. “We have to combat this delirium in order to be successful in taking these patients off of ventilators,” she said. Dr. Narasimhan added that more research is needed on areas including drug-to-drug interactions, duration of efficacy of various drugs, and how the virus affects the brain.
“Adherence to the ABCDEF bundle can reduce the incidence of delirium, from approximately 75% of mechanically ventilated patients to 50% or less,” David L. Bowton, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., said in an interview.
“Importantly, in most studies, bundle adherence reduces mortality and ICU length of stay and lowers the total cost of care. However, isolation of patients and protection of staff, visitor restrictions, and potentially stressed staffing will likely alter how most institutions approach bundle compliance,” he said. “Gathering input from infection control clinicians and bedside providers from multiple disciplines that consider these factors to critically examine current bundle procedures and workflow will be essential to the creation and/or revision of bundle processes of care that maintain the integrity of the ABCDEF bundle yet preserve staff, patient, and family safety,” he said.
“We did not have strong evidence to suggest an optimal approach to treating delirium before the advent of the COVID-19 pandemic, so I do not believe we know what the best approach is in the current environment,” Dr. Bowton added. “Further, vigilance will be necessary to ensure that altered consciousness or cognition is ICU delirium and not attributable to another cause such as drug withdrawal, drug adverse effect, or primary central nervous system infection or immune response that mandates specific therapy,” he emphasized.
For clinicians, “this study reminds us of the importance of the ABCDEF bundle to improve outcomes of critical illness,” said Dr. Bowton. “It highlights the difficulties of providing frequent reassessment of pain, comfort, reassurance, and reorientation to critically ill patients. To me, it underscores the importance of each institution critically examining staffing needs and staffing roles to mitigate these difficulties and to explore novel methods of maintaining staff-patient and family-patient interactions to enhance compliance with all elements of the ABCDEF bundle while maintaining the safety of staff and families.”
Dr. Bowton added, “When necessary, explicit modifications to existing ABCDEF bundles should be developed and disseminated to provide realistic, readily understood guidance to achieve the best possible compliance with each bundle element. One potentially underrecognized issue will be the large, hopefully temporary, number of people requiring post–critical illness rehabilitation and mental health services,” he said. “In many regions these services are already underfunded and ill-equipped to handle an increased demand for these services,” he noted.
Additional research is needed in many areas, said Dr. Bowton. “While compliance with the ABCDEF bundle decreases the incidence and duration of delirium, decreases ICU length of stay, decreases duration of mechanical ventilation, and improves mortality, many questions remain. Individual elements of the bundle have been inconsistently associated with improved outcomes,” he said. “What is the relative importance of specific elements and what are the mechanisms by which they improve outcomes?” he asked. “We still do not know how to best achieve physical/functional recovery following critical illness, which, in light of these authors’ studies relating persisting physical debility to depression (Lancet Respir Med. 2014; 2[5]:369-79), may be a key component to improving long-term outcomes,” he said.
The study received no specific funding, although several coauthors disclosed grants from agencies including the National Center for Advancing Translational Sciences, National Institute of General Medical Sciences, National Heart, Lung, and Blood Institute, and National Institute on Aging. Dr. Narasimhan and Dr. Bowton had no financial conflicts to disclose.
SOURCE: Kotfis K et al. Critical Care. 2020 Apr 28. doi: 10.1186/s13054-020-02882-x.
, and a bedside risk management strategy based on modifiable risk factors can help prevent lingering effects on cognition, according to an article published in Critical Care.
Several factors can contribute to an increased risk of ICU delirium in COVID-19 patients, wrote Katarzyna Kotfis, MD, of Pomeranian Medical University, Szczecin, Poland, and colleagues.
“In patients with COVID-19, delirium may be a manifestation of direct central nervous system invasion, induction of CNS inflammatory mediators, a secondary effect of other organ system failure, an effect of sedative strategies, prolonged mechanical ventilation time, or environmental factors, including social isolation,” they said.
Delirium in the context of COVID-19 can mean an early sign of infection, so patients should be screened using dedicated psychometric tools, the researchers wrote. Also, COVID-19 has been shown to cause pneumonia in elderly patients, who are at high risk for severe pulmonary disease related to COVID-19 and for ICU delirium generally, they said.
In addition, don’t underestimate the impact of social isolation created by quarantines, the researchers said.
“What is needed now, is not only high-quality ICU care, concentrated on providing adequate respiratory support to critically ill patients, but an identification of the source and degree of mental and spiritual suffering of patients as well as their families to provide the most ethical and person-centered care during this humanitarian crisis,” they emphasized. However, they acknowledged that nonpharmacologic interventions such as mobility outside the ICU room and interactions with family members are limited by the COVID-19 situation.
The researchers noted several mechanisms by which the COVID-19 virus may cause brain damage, including through the dysfunction of the renin-angiotensin system.
“Inflammatory response of the CNS to viral infection seems to be another important reason for poor neurological outcome and occurrence of delirium,” in COVID-19 patients, they said.
As for risk-reduction strategies, the researchers noted that “delirium in mechanically ventilated patients can be reduced dramatically to 50% using a culture of lighter sedation and mobilization via the implementation of the safety bundle called the ABCDEFs promoted by the Society of Critical Care Medicine in their ICU Liberation Collaborative,” although COVID-19 isolation is a barrier, they said.
The ABCDEF bundle consists of Assessment of pain, Both spontaneous awakening trials and spontaneous breathing trials, Choice of sedation, Delirium (hyperactive or hypoactive), Early mobility, and Family presence; all of which are challenging in the COVID-19 environment, the researchers said.
They advised implementing easy screening methods for delirium to reduce the burden on medical staff, and emphasized the importance of regular patient orientation, despite social separation from family and caregivers.
“No drugs can be recommended for the prevention or treatment of ICU delirium other than avoidance of overuse of potent psychoactive agents like sedatives and neuromuscular blockers (NMB) unless patients absolutely require such management,” they added.
“Delirium is so common and so hard to manage in the COVID-19 population,” Mangala Narasimhan, DO, of Northwell Health in New Hyde Park, N.Y., said in an interview. Delirium is impacted by many sources including a viral encephalopathy, the amount and duration of sedation medications, and prolonged intubation and hypoxemia, she said. “Managing the delirium allows you to wake the patient up successfully and without a lot of discoordination. This will help with weaning,” she noted. Barriers to delirium management for COVID-19 patients include the length of time on a ventilator, as well as amount of sedatives and paralytics, and the added issues of renal insufficiency, she noted. “How they can be addressed is thoughtful plans on the addition of long-term sedation for withdrawal symptoms, and anxiolytics for the profound anxiety associated with arousal from this type of sedation on ventilators, she said. The take-home message for clinicians is the need to perform weaning trials to manage delirium in the ICU. “We have to combat this delirium in order to be successful in taking these patients off of ventilators,” she said. Dr. Narasimhan added that more research is needed on areas including drug-to-drug interactions, duration of efficacy of various drugs, and how the virus affects the brain.
“Adherence to the ABCDEF bundle can reduce the incidence of delirium, from approximately 75% of mechanically ventilated patients to 50% or less,” David L. Bowton, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., said in an interview.
“Importantly, in most studies, bundle adherence reduces mortality and ICU length of stay and lowers the total cost of care. However, isolation of patients and protection of staff, visitor restrictions, and potentially stressed staffing will likely alter how most institutions approach bundle compliance,” he said. “Gathering input from infection control clinicians and bedside providers from multiple disciplines that consider these factors to critically examine current bundle procedures and workflow will be essential to the creation and/or revision of bundle processes of care that maintain the integrity of the ABCDEF bundle yet preserve staff, patient, and family safety,” he said.
“We did not have strong evidence to suggest an optimal approach to treating delirium before the advent of the COVID-19 pandemic, so I do not believe we know what the best approach is in the current environment,” Dr. Bowton added. “Further, vigilance will be necessary to ensure that altered consciousness or cognition is ICU delirium and not attributable to another cause such as drug withdrawal, drug adverse effect, or primary central nervous system infection or immune response that mandates specific therapy,” he emphasized.
For clinicians, “this study reminds us of the importance of the ABCDEF bundle to improve outcomes of critical illness,” said Dr. Bowton. “It highlights the difficulties of providing frequent reassessment of pain, comfort, reassurance, and reorientation to critically ill patients. To me, it underscores the importance of each institution critically examining staffing needs and staffing roles to mitigate these difficulties and to explore novel methods of maintaining staff-patient and family-patient interactions to enhance compliance with all elements of the ABCDEF bundle while maintaining the safety of staff and families.”
Dr. Bowton added, “When necessary, explicit modifications to existing ABCDEF bundles should be developed and disseminated to provide realistic, readily understood guidance to achieve the best possible compliance with each bundle element. One potentially underrecognized issue will be the large, hopefully temporary, number of people requiring post–critical illness rehabilitation and mental health services,” he said. “In many regions these services are already underfunded and ill-equipped to handle an increased demand for these services,” he noted.
Additional research is needed in many areas, said Dr. Bowton. “While compliance with the ABCDEF bundle decreases the incidence and duration of delirium, decreases ICU length of stay, decreases duration of mechanical ventilation, and improves mortality, many questions remain. Individual elements of the bundle have been inconsistently associated with improved outcomes,” he said. “What is the relative importance of specific elements and what are the mechanisms by which they improve outcomes?” he asked. “We still do not know how to best achieve physical/functional recovery following critical illness, which, in light of these authors’ studies relating persisting physical debility to depression (Lancet Respir Med. 2014; 2[5]:369-79), may be a key component to improving long-term outcomes,” he said.
The study received no specific funding, although several coauthors disclosed grants from agencies including the National Center for Advancing Translational Sciences, National Institute of General Medical Sciences, National Heart, Lung, and Blood Institute, and National Institute on Aging. Dr. Narasimhan and Dr. Bowton had no financial conflicts to disclose.
SOURCE: Kotfis K et al. Critical Care. 2020 Apr 28. doi: 10.1186/s13054-020-02882-x.
FROM CRITICAL CARE
Too much or too little sleep spikes constipation
Individuals who sleep more or less than average report significantly more constipation, compared with normal sleepers, based on data from 14,590 adults.
“Normal sleep duration is thought to be essential for healthy bowel function; however, the effect of either limited or excessive sleep duration on bowel patterns is poorly understood,” Adeyinka Adejumo, MD, of North Shore Medical Center, Salem, Mass., and colleagues wrote in an abstract released as part of the annual Digestive Disease Week®, which was canceled because of COVID-19.
To examine the association between sleep duration and bowel function, the researchers identified 14,590 adults aged 20 years and older who completed questionnaires on sleep and bowel health as part of the National Health and Nutrition Examination Survey (NHANES) during 2005-2010.
Sleep was divided into three categories based on standards from the National Sleep Foundation: short (less than 7 hours), normal (7-8 hours) and long (more than 8 hours).
Overall, constipation rates were significantly lower among normal sleepers (8.3%) compared with both short and long sleepers (11.0% and 12.5%, respectively; P < .0001 for both).
Bowel function was defined as normal, constipation, or diarrhea based on stool form and bowel movements per week. After controlling for demographic, lifestyle, and dietary factors, long sleepers and short sleepers were 61% and 38% more likely, respectively, to report constipation, compared with normal sleepers.
However, sleep duration was not related to diarrhea, the researchers noted. In addition, “A sensitivity analysis revealed that sleep duration did not mediate the relationship between comorbid factors (such as overall health, poverty index, obesity, and body mass index) and constipation,” they wrote.
The results suggest that decreased sleep is associated with constipation among adults in the United States, the researchers said. However, “further studies are needed to evaluate the physiologic mechanisms driving the impact of sleep duration on bowel function to determine whether sleep disorders or their underlying causes affect constipation,” they concluded.
“This study was necessary because up to 50% of Americans suffer from sleep disorders, out of which abnormal sleep duration is one of the most common and underdiagnosed, and associated with other diseases such as hypertension and diabetes,” Dr. Adejumo said in an interview. “However, disorders of bowel function (constipation and diarrhea), which affect almost 10%-15% of the population and result in significant health care burden, such as higher cost, hospital visits, abdominal discomfort, have not been studied among individuals with suboptimal sleep duration.”
Dr. Adejumo said he and his colleagues were surprised by their findings. “Although, based on our hypothesis, we thought that sleeping too long may be associated with constipation, we were shocked to note similar results among people who also sleep for short durations,” he noted.
“Previous studies had suggested that bowel contraction slows down considerably during sleep. It, therefore, will make sense that sleeping for too long may result in suppressed bowel motility and decreased bowel movement,” he said. “However, our results showed similar findings among short sleepers. We do not know the exact mechanism of these results. It may be that short sleep resulted in inadequate bowel rest, bowel muscle fatigue, and, subsequently, decreased bowel movement,” said Dr. Adejumo. “Or it may also be that brain-gut signaling pathways are disrupted among short sleepers, as is seen among IBS patients after a poor night sleep, resulting in higher constipation,” he added.
Clinicians should be aware of the impact of both short and long sleep on constipation, said Dr. Adejumo. “Individuals who are unable to have adequate periods of sleep due to other diseases, including insomnia, disrupted job schedules, or conditions with too long sleep, such as narcolepsy, may all additionally suffer from constipation. Such patients may need regular evaluation and treatment for constipation to improve their discomfort,” he said.
“To confirm our findings, other clinical studies with more granular data on sleep and constipation, are needed, as well as translational research to uncover the potential mechanisms of these findings,” he emphasized.
The researchers had no financial conflicts to disclose.
SOURCE: Adejumo A et al. DDW 2020. Abstract Sa1711.
Individuals who sleep more or less than average report significantly more constipation, compared with normal sleepers, based on data from 14,590 adults.
“Normal sleep duration is thought to be essential for healthy bowel function; however, the effect of either limited or excessive sleep duration on bowel patterns is poorly understood,” Adeyinka Adejumo, MD, of North Shore Medical Center, Salem, Mass., and colleagues wrote in an abstract released as part of the annual Digestive Disease Week®, which was canceled because of COVID-19.
To examine the association between sleep duration and bowel function, the researchers identified 14,590 adults aged 20 years and older who completed questionnaires on sleep and bowel health as part of the National Health and Nutrition Examination Survey (NHANES) during 2005-2010.
Sleep was divided into three categories based on standards from the National Sleep Foundation: short (less than 7 hours), normal (7-8 hours) and long (more than 8 hours).
Overall, constipation rates were significantly lower among normal sleepers (8.3%) compared with both short and long sleepers (11.0% and 12.5%, respectively; P < .0001 for both).
Bowel function was defined as normal, constipation, or diarrhea based on stool form and bowel movements per week. After controlling for demographic, lifestyle, and dietary factors, long sleepers and short sleepers were 61% and 38% more likely, respectively, to report constipation, compared with normal sleepers.
However, sleep duration was not related to diarrhea, the researchers noted. In addition, “A sensitivity analysis revealed that sleep duration did not mediate the relationship between comorbid factors (such as overall health, poverty index, obesity, and body mass index) and constipation,” they wrote.
The results suggest that decreased sleep is associated with constipation among adults in the United States, the researchers said. However, “further studies are needed to evaluate the physiologic mechanisms driving the impact of sleep duration on bowel function to determine whether sleep disorders or their underlying causes affect constipation,” they concluded.
“This study was necessary because up to 50% of Americans suffer from sleep disorders, out of which abnormal sleep duration is one of the most common and underdiagnosed, and associated with other diseases such as hypertension and diabetes,” Dr. Adejumo said in an interview. “However, disorders of bowel function (constipation and diarrhea), which affect almost 10%-15% of the population and result in significant health care burden, such as higher cost, hospital visits, abdominal discomfort, have not been studied among individuals with suboptimal sleep duration.”
Dr. Adejumo said he and his colleagues were surprised by their findings. “Although, based on our hypothesis, we thought that sleeping too long may be associated with constipation, we were shocked to note similar results among people who also sleep for short durations,” he noted.
“Previous studies had suggested that bowel contraction slows down considerably during sleep. It, therefore, will make sense that sleeping for too long may result in suppressed bowel motility and decreased bowel movement,” he said. “However, our results showed similar findings among short sleepers. We do not know the exact mechanism of these results. It may be that short sleep resulted in inadequate bowel rest, bowel muscle fatigue, and, subsequently, decreased bowel movement,” said Dr. Adejumo. “Or it may also be that brain-gut signaling pathways are disrupted among short sleepers, as is seen among IBS patients after a poor night sleep, resulting in higher constipation,” he added.
Clinicians should be aware of the impact of both short and long sleep on constipation, said Dr. Adejumo. “Individuals who are unable to have adequate periods of sleep due to other diseases, including insomnia, disrupted job schedules, or conditions with too long sleep, such as narcolepsy, may all additionally suffer from constipation. Such patients may need regular evaluation and treatment for constipation to improve their discomfort,” he said.
“To confirm our findings, other clinical studies with more granular data on sleep and constipation, are needed, as well as translational research to uncover the potential mechanisms of these findings,” he emphasized.
The researchers had no financial conflicts to disclose.
SOURCE: Adejumo A et al. DDW 2020. Abstract Sa1711.
Individuals who sleep more or less than average report significantly more constipation, compared with normal sleepers, based on data from 14,590 adults.
“Normal sleep duration is thought to be essential for healthy bowel function; however, the effect of either limited or excessive sleep duration on bowel patterns is poorly understood,” Adeyinka Adejumo, MD, of North Shore Medical Center, Salem, Mass., and colleagues wrote in an abstract released as part of the annual Digestive Disease Week®, which was canceled because of COVID-19.
To examine the association between sleep duration and bowel function, the researchers identified 14,590 adults aged 20 years and older who completed questionnaires on sleep and bowel health as part of the National Health and Nutrition Examination Survey (NHANES) during 2005-2010.
Sleep was divided into three categories based on standards from the National Sleep Foundation: short (less than 7 hours), normal (7-8 hours) and long (more than 8 hours).
Overall, constipation rates were significantly lower among normal sleepers (8.3%) compared with both short and long sleepers (11.0% and 12.5%, respectively; P < .0001 for both).
Bowel function was defined as normal, constipation, or diarrhea based on stool form and bowel movements per week. After controlling for demographic, lifestyle, and dietary factors, long sleepers and short sleepers were 61% and 38% more likely, respectively, to report constipation, compared with normal sleepers.
However, sleep duration was not related to diarrhea, the researchers noted. In addition, “A sensitivity analysis revealed that sleep duration did not mediate the relationship between comorbid factors (such as overall health, poverty index, obesity, and body mass index) and constipation,” they wrote.
The results suggest that decreased sleep is associated with constipation among adults in the United States, the researchers said. However, “further studies are needed to evaluate the physiologic mechanisms driving the impact of sleep duration on bowel function to determine whether sleep disorders or their underlying causes affect constipation,” they concluded.
“This study was necessary because up to 50% of Americans suffer from sleep disorders, out of which abnormal sleep duration is one of the most common and underdiagnosed, and associated with other diseases such as hypertension and diabetes,” Dr. Adejumo said in an interview. “However, disorders of bowel function (constipation and diarrhea), which affect almost 10%-15% of the population and result in significant health care burden, such as higher cost, hospital visits, abdominal discomfort, have not been studied among individuals with suboptimal sleep duration.”
Dr. Adejumo said he and his colleagues were surprised by their findings. “Although, based on our hypothesis, we thought that sleeping too long may be associated with constipation, we were shocked to note similar results among people who also sleep for short durations,” he noted.
“Previous studies had suggested that bowel contraction slows down considerably during sleep. It, therefore, will make sense that sleeping for too long may result in suppressed bowel motility and decreased bowel movement,” he said. “However, our results showed similar findings among short sleepers. We do not know the exact mechanism of these results. It may be that short sleep resulted in inadequate bowel rest, bowel muscle fatigue, and, subsequently, decreased bowel movement,” said Dr. Adejumo. “Or it may also be that brain-gut signaling pathways are disrupted among short sleepers, as is seen among IBS patients after a poor night sleep, resulting in higher constipation,” he added.
Clinicians should be aware of the impact of both short and long sleep on constipation, said Dr. Adejumo. “Individuals who are unable to have adequate periods of sleep due to other diseases, including insomnia, disrupted job schedules, or conditions with too long sleep, such as narcolepsy, may all additionally suffer from constipation. Such patients may need regular evaluation and treatment for constipation to improve their discomfort,” he said.
“To confirm our findings, other clinical studies with more granular data on sleep and constipation, are needed, as well as translational research to uncover the potential mechanisms of these findings,” he emphasized.
The researchers had no financial conflicts to disclose.
SOURCE: Adejumo A et al. DDW 2020. Abstract Sa1711.
FROM DDW 2020
Key clinical point: Both short sleepers and long sleepers reported significantly more constipation compared with normal sleepers.
Major finding: Overall constipation rates were 8.3% in normal sleepers, compared with 11.0% for short sleepers and 12.5% for long sleepers.
Study details: The data come from 14,590 adults who participated in NHANES between 2005 and 2010.
Disclosures: The researchers had no financial conflicts to disclose.
Source: Adejumo A et al. DDW 2020. Abstract Sa1711.
Postpropofol driving poses low risk to endoscopy patients
Adults given propofol as part of an elective outpatient endoscopy procedure showed similar driving skills after postsedation recovery and prior to the procedure, based on simulation data from an open-label study of 41 patients.
Although current guidelines recommend that patients refrain from driving for 24 hours after propofol sedation and be accompanied by a responsible adult, data on the driving skills of patients after postsedation recovery are limited, Pooja Lal, MD, of the Cleveland Clinic Foundation and colleagues wrote in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19.
“We assessed psychomotor recovery using a driving simulator which mimics real-life driving in outpatients undergoing gastrointestinal endoscopy with propofol,” they wrote.
The researchers enrolled 41 outpatients who were given propofol for various elective procedures at an endoscopy unit of a single center. Patients’ driving skills were tested at baseline and after postsedation recovery using a driving simulator. Postsedation recovery was defined as Aldrete score of 9 in the recovery room. Patients were excluded from the study if they demonstrated altered mental status of any type including dementia, delirium, and hepatic encephalopathy; if they were legally blind; or were currently inpatients.
Overall, driving skills were not significantly different between preprocedure and postsedation recovery on measures of number of times over the speed limit (3.2 vs. 3.4), number of times drivers went off the road (0.37 vs. 0.54), and total pedal reaction time (6.1 seconds vs. 7.6 seconds).
“The two variables including gas pedal reaction time and the total number of collisions did not follow normal distribution,” with medians of 0.70 for gas pedal reaction time in both groups and medians of 0 collisions for both groups, the investigators noted.
The study findings were limited by the small sample size and open-label design. However, the results suggest that driving skills were similar for patients at baseline and after achieving a postsedation Aldrete score of 9, the researchers wrote. Based on these findings, “current recommendations that patients should refrain from driving and unescorted use of public transport for 24 hours after sedation may need to be reconsidered in patients who receive propofol sedation.”
“With this study, we are aiming to identify the correct patient population who could potentially drive themselves home after their procedure rather than having to arrange for transportation,” Dr. Lal said in an interview.
“The significant cost associated with the daylong interruption of the activities of daily living, having a family member accompany them for their procedures, or not being able to use public transport unescorted may deter some patients from complying with colonoscopy screenings and other important endoscopic procedures,” she explained.
“There are patients who arrive for their procedure without any accompanying family members and we have to admit them to an observation unit overnight or reschedule their procedures. The expense and inconvenience associated with the extended recovery potentially could be an impediment to many important screening exams,” she noted. “In the setting of increased awareness regarding the need for these screening exams, this study is important to highlight these barriers and propose a solution for them.”
The potential costs of lost salaries is extremely high, she said. “If we assume that the 24-hour recovery period necessitates taking a day off from work, the value of lost salary per patient would be $183.68 as per the 2019 national hourly average wage. With an estimated 19 million colonoscopies performed annually in the United States, the aggregate cost of lost wages with the 24-hour guideline would be $3.5 billion. This amount does not account for the lost wages of the accompanying family member.”
Dr. Lal said she and her colleagues were not surprised by the findings. “The endoscopists in our endoscopy unit have noted that patients recover much more rapidly after sedation with propofol compared with other sedative agents. This observation led to the hypothesis that those patients receiving propofol should have a speedy psychomotor recovery and should be able to drive the same day. Our findings are in accordance with our observations.” However, “larger and preferably multicenter studies are needed to validate these findings and add to our knowledge about the postsedation psychomotor recovery,” said Dr. Lal. She added that the study is ongoing and the researchers have collected data from a total of 63 patients, which increases the power of the results.
The researchers had no financial conflicts to disclose.
*This story was updated on 5/8/2020.
SOURCE: Lal P et al. DDW 2020, Abstract 295.
Adults given propofol as part of an elective outpatient endoscopy procedure showed similar driving skills after postsedation recovery and prior to the procedure, based on simulation data from an open-label study of 41 patients.
Although current guidelines recommend that patients refrain from driving for 24 hours after propofol sedation and be accompanied by a responsible adult, data on the driving skills of patients after postsedation recovery are limited, Pooja Lal, MD, of the Cleveland Clinic Foundation and colleagues wrote in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19.
“We assessed psychomotor recovery using a driving simulator which mimics real-life driving in outpatients undergoing gastrointestinal endoscopy with propofol,” they wrote.
The researchers enrolled 41 outpatients who were given propofol for various elective procedures at an endoscopy unit of a single center. Patients’ driving skills were tested at baseline and after postsedation recovery using a driving simulator. Postsedation recovery was defined as Aldrete score of 9 in the recovery room. Patients were excluded from the study if they demonstrated altered mental status of any type including dementia, delirium, and hepatic encephalopathy; if they were legally blind; or were currently inpatients.
Overall, driving skills were not significantly different between preprocedure and postsedation recovery on measures of number of times over the speed limit (3.2 vs. 3.4), number of times drivers went off the road (0.37 vs. 0.54), and total pedal reaction time (6.1 seconds vs. 7.6 seconds).
“The two variables including gas pedal reaction time and the total number of collisions did not follow normal distribution,” with medians of 0.70 for gas pedal reaction time in both groups and medians of 0 collisions for both groups, the investigators noted.
The study findings were limited by the small sample size and open-label design. However, the results suggest that driving skills were similar for patients at baseline and after achieving a postsedation Aldrete score of 9, the researchers wrote. Based on these findings, “current recommendations that patients should refrain from driving and unescorted use of public transport for 24 hours after sedation may need to be reconsidered in patients who receive propofol sedation.”
“With this study, we are aiming to identify the correct patient population who could potentially drive themselves home after their procedure rather than having to arrange for transportation,” Dr. Lal said in an interview.
“The significant cost associated with the daylong interruption of the activities of daily living, having a family member accompany them for their procedures, or not being able to use public transport unescorted may deter some patients from complying with colonoscopy screenings and other important endoscopic procedures,” she explained.
“There are patients who arrive for their procedure without any accompanying family members and we have to admit them to an observation unit overnight or reschedule their procedures. The expense and inconvenience associated with the extended recovery potentially could be an impediment to many important screening exams,” she noted. “In the setting of increased awareness regarding the need for these screening exams, this study is important to highlight these barriers and propose a solution for them.”
The potential costs of lost salaries is extremely high, she said. “If we assume that the 24-hour recovery period necessitates taking a day off from work, the value of lost salary per patient would be $183.68 as per the 2019 national hourly average wage. With an estimated 19 million colonoscopies performed annually in the United States, the aggregate cost of lost wages with the 24-hour guideline would be $3.5 billion. This amount does not account for the lost wages of the accompanying family member.”
Dr. Lal said she and her colleagues were not surprised by the findings. “The endoscopists in our endoscopy unit have noted that patients recover much more rapidly after sedation with propofol compared with other sedative agents. This observation led to the hypothesis that those patients receiving propofol should have a speedy psychomotor recovery and should be able to drive the same day. Our findings are in accordance with our observations.” However, “larger and preferably multicenter studies are needed to validate these findings and add to our knowledge about the postsedation psychomotor recovery,” said Dr. Lal. She added that the study is ongoing and the researchers have collected data from a total of 63 patients, which increases the power of the results.
The researchers had no financial conflicts to disclose.
*This story was updated on 5/8/2020.
SOURCE: Lal P et al. DDW 2020, Abstract 295.
Adults given propofol as part of an elective outpatient endoscopy procedure showed similar driving skills after postsedation recovery and prior to the procedure, based on simulation data from an open-label study of 41 patients.
Although current guidelines recommend that patients refrain from driving for 24 hours after propofol sedation and be accompanied by a responsible adult, data on the driving skills of patients after postsedation recovery are limited, Pooja Lal, MD, of the Cleveland Clinic Foundation and colleagues wrote in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19.
“We assessed psychomotor recovery using a driving simulator which mimics real-life driving in outpatients undergoing gastrointestinal endoscopy with propofol,” they wrote.
The researchers enrolled 41 outpatients who were given propofol for various elective procedures at an endoscopy unit of a single center. Patients’ driving skills were tested at baseline and after postsedation recovery using a driving simulator. Postsedation recovery was defined as Aldrete score of 9 in the recovery room. Patients were excluded from the study if they demonstrated altered mental status of any type including dementia, delirium, and hepatic encephalopathy; if they were legally blind; or were currently inpatients.
Overall, driving skills were not significantly different between preprocedure and postsedation recovery on measures of number of times over the speed limit (3.2 vs. 3.4), number of times drivers went off the road (0.37 vs. 0.54), and total pedal reaction time (6.1 seconds vs. 7.6 seconds).
“The two variables including gas pedal reaction time and the total number of collisions did not follow normal distribution,” with medians of 0.70 for gas pedal reaction time in both groups and medians of 0 collisions for both groups, the investigators noted.
The study findings were limited by the small sample size and open-label design. However, the results suggest that driving skills were similar for patients at baseline and after achieving a postsedation Aldrete score of 9, the researchers wrote. Based on these findings, “current recommendations that patients should refrain from driving and unescorted use of public transport for 24 hours after sedation may need to be reconsidered in patients who receive propofol sedation.”
“With this study, we are aiming to identify the correct patient population who could potentially drive themselves home after their procedure rather than having to arrange for transportation,” Dr. Lal said in an interview.
“The significant cost associated with the daylong interruption of the activities of daily living, having a family member accompany them for their procedures, or not being able to use public transport unescorted may deter some patients from complying with colonoscopy screenings and other important endoscopic procedures,” she explained.
“There are patients who arrive for their procedure without any accompanying family members and we have to admit them to an observation unit overnight or reschedule their procedures. The expense and inconvenience associated with the extended recovery potentially could be an impediment to many important screening exams,” she noted. “In the setting of increased awareness regarding the need for these screening exams, this study is important to highlight these barriers and propose a solution for them.”
The potential costs of lost salaries is extremely high, she said. “If we assume that the 24-hour recovery period necessitates taking a day off from work, the value of lost salary per patient would be $183.68 as per the 2019 national hourly average wage. With an estimated 19 million colonoscopies performed annually in the United States, the aggregate cost of lost wages with the 24-hour guideline would be $3.5 billion. This amount does not account for the lost wages of the accompanying family member.”
Dr. Lal said she and her colleagues were not surprised by the findings. “The endoscopists in our endoscopy unit have noted that patients recover much more rapidly after sedation with propofol compared with other sedative agents. This observation led to the hypothesis that those patients receiving propofol should have a speedy psychomotor recovery and should be able to drive the same day. Our findings are in accordance with our observations.” However, “larger and preferably multicenter studies are needed to validate these findings and add to our knowledge about the postsedation psychomotor recovery,” said Dr. Lal. She added that the study is ongoing and the researchers have collected data from a total of 63 patients, which increases the power of the results.
The researchers had no financial conflicts to disclose.
*This story was updated on 5/8/2020.
SOURCE: Lal P et al. DDW 2020, Abstract 295.
FROM DDW 2020
Key clinical point: Patients who received propofol prior to endoscopic procedures showed no significant difference in driving ability from before the procedure to postsedation recovery.
Major finding: A simulated measure of driving ability showed similar competence before and after endoscopic procedures (number of times over the speed limit, 3.2 and 3.4, respectively).
Study details: The data come from a prospective, open-label study of 41 adults who underwent endoscopic procedures at a single center.
Disclosures: The researchers had no financial conflicts to disclose.
Source: Lal P et al. DDW 2020, Abstract 295.
Renal function data improve risk stratification in patients with PAH
The REVEAL-based risk-management strategy was significantly more effective than the current European Society of Cardiology guidelines at discriminating risk in adults with pulmonary arterial hypertension, and renal function significantly improved risk stratification, findings from a retrospective registry study suggest.
“Although the importance of identification of low or high risk is intuitive, the clinical utility of stratification into the intermediate-risk category is less certain” in patients with pulmonary arterial hypertension (PAH), wrote Jason G.E. Zelt, MSc, of the University of Ottawa and colleagues. “Despite the importance of renal function in the PAH population, it has not been formally incorporated into many of the contemporary PAH risk tools, including current guidelines,” they noted.
In a study published in the Journal of Heart and Lung Transplantation, the researchers compared several current research tools for risk assessment in PAH, including the registry to evaluate early and long-term pulmonary arterial hypertension disease management (REVEAL) risk calculator, the French Pulmonary Hypertension Registry (FPHR), and guidelines from the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). They also reviewed REVEAL 2.0, an update that included the estimated glomerular filtration rate (eGFR) as a measure of renal function.
The study population included 211 adults with PAH seen at a single pulmonary hypertension clinic; the average age was 63 years and 65% were women. In addition, 42% had at least stage 3 chronic kidney disease. The primary endpoint was transplant-free survival, which was a median of 7 years. Creatinine was assessed at baseline in all patients. In addition, patients were grouped based on the percent change in renal function between diagnosis and 6 months.
Although the ESC and REVEAL algorithms significantly stratified transplant-free survival risk, the researchers found little agreement among the algorithms in stratifying transplant-free survival for patients in the intermediate-risk category.
However, using REVEAL 2.0, both renal function at diagnosis and renal function at 6 months were significant predictors (P < .0001 for both) from intermediate-risk to higher- or lower-risk groups, the researchers said.
“A decrease in renal function may be a harbinger of both [right ventricle] dysfunction and further PAH disease progression. However, further research is needed to confirm whether declining eGFR is a sentinel biomarker in prospective cohorts,” the researchers said.
The study findings were limited by several factors including the retrospective design and the use of mainly baseline data without information on long-term risk assessment, the researchers noted. However, “a key finding of our study was the ability of baseline eGFR to robustly restratify ESC/ERS-based risk strategies,” they said. “Our work highlights key limitations of the ESC/ERS-based risk assessment, and suggests that incorporating measures of kidney function are important strategies moving forward,” they concluded.
Mr. Zelt is an MD/PhD student and had no financial conflicts to disclose. Some coauthors disclosed relationships with Actelion Pharmaceuticals, Bayer Pharmaceuticals, and Northern Therapeutics.
SOURCE: Zelt JGE et al. J Heart Lung Transplant. 2020 Apr 5. doi: 10.1016/j.healun.2020.03.026.
The REVEAL-based risk-management strategy was significantly more effective than the current European Society of Cardiology guidelines at discriminating risk in adults with pulmonary arterial hypertension, and renal function significantly improved risk stratification, findings from a retrospective registry study suggest.
“Although the importance of identification of low or high risk is intuitive, the clinical utility of stratification into the intermediate-risk category is less certain” in patients with pulmonary arterial hypertension (PAH), wrote Jason G.E. Zelt, MSc, of the University of Ottawa and colleagues. “Despite the importance of renal function in the PAH population, it has not been formally incorporated into many of the contemporary PAH risk tools, including current guidelines,” they noted.
In a study published in the Journal of Heart and Lung Transplantation, the researchers compared several current research tools for risk assessment in PAH, including the registry to evaluate early and long-term pulmonary arterial hypertension disease management (REVEAL) risk calculator, the French Pulmonary Hypertension Registry (FPHR), and guidelines from the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). They also reviewed REVEAL 2.0, an update that included the estimated glomerular filtration rate (eGFR) as a measure of renal function.
The study population included 211 adults with PAH seen at a single pulmonary hypertension clinic; the average age was 63 years and 65% were women. In addition, 42% had at least stage 3 chronic kidney disease. The primary endpoint was transplant-free survival, which was a median of 7 years. Creatinine was assessed at baseline in all patients. In addition, patients were grouped based on the percent change in renal function between diagnosis and 6 months.
Although the ESC and REVEAL algorithms significantly stratified transplant-free survival risk, the researchers found little agreement among the algorithms in stratifying transplant-free survival for patients in the intermediate-risk category.
However, using REVEAL 2.0, both renal function at diagnosis and renal function at 6 months were significant predictors (P < .0001 for both) from intermediate-risk to higher- or lower-risk groups, the researchers said.
“A decrease in renal function may be a harbinger of both [right ventricle] dysfunction and further PAH disease progression. However, further research is needed to confirm whether declining eGFR is a sentinel biomarker in prospective cohorts,” the researchers said.
The study findings were limited by several factors including the retrospective design and the use of mainly baseline data without information on long-term risk assessment, the researchers noted. However, “a key finding of our study was the ability of baseline eGFR to robustly restratify ESC/ERS-based risk strategies,” they said. “Our work highlights key limitations of the ESC/ERS-based risk assessment, and suggests that incorporating measures of kidney function are important strategies moving forward,” they concluded.
Mr. Zelt is an MD/PhD student and had no financial conflicts to disclose. Some coauthors disclosed relationships with Actelion Pharmaceuticals, Bayer Pharmaceuticals, and Northern Therapeutics.
SOURCE: Zelt JGE et al. J Heart Lung Transplant. 2020 Apr 5. doi: 10.1016/j.healun.2020.03.026.
The REVEAL-based risk-management strategy was significantly more effective than the current European Society of Cardiology guidelines at discriminating risk in adults with pulmonary arterial hypertension, and renal function significantly improved risk stratification, findings from a retrospective registry study suggest.
“Although the importance of identification of low or high risk is intuitive, the clinical utility of stratification into the intermediate-risk category is less certain” in patients with pulmonary arterial hypertension (PAH), wrote Jason G.E. Zelt, MSc, of the University of Ottawa and colleagues. “Despite the importance of renal function in the PAH population, it has not been formally incorporated into many of the contemporary PAH risk tools, including current guidelines,” they noted.
In a study published in the Journal of Heart and Lung Transplantation, the researchers compared several current research tools for risk assessment in PAH, including the registry to evaluate early and long-term pulmonary arterial hypertension disease management (REVEAL) risk calculator, the French Pulmonary Hypertension Registry (FPHR), and guidelines from the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). They also reviewed REVEAL 2.0, an update that included the estimated glomerular filtration rate (eGFR) as a measure of renal function.
The study population included 211 adults with PAH seen at a single pulmonary hypertension clinic; the average age was 63 years and 65% were women. In addition, 42% had at least stage 3 chronic kidney disease. The primary endpoint was transplant-free survival, which was a median of 7 years. Creatinine was assessed at baseline in all patients. In addition, patients were grouped based on the percent change in renal function between diagnosis and 6 months.
Although the ESC and REVEAL algorithms significantly stratified transplant-free survival risk, the researchers found little agreement among the algorithms in stratifying transplant-free survival for patients in the intermediate-risk category.
However, using REVEAL 2.0, both renal function at diagnosis and renal function at 6 months were significant predictors (P < .0001 for both) from intermediate-risk to higher- or lower-risk groups, the researchers said.
“A decrease in renal function may be a harbinger of both [right ventricle] dysfunction and further PAH disease progression. However, further research is needed to confirm whether declining eGFR is a sentinel biomarker in prospective cohorts,” the researchers said.
The study findings were limited by several factors including the retrospective design and the use of mainly baseline data without information on long-term risk assessment, the researchers noted. However, “a key finding of our study was the ability of baseline eGFR to robustly restratify ESC/ERS-based risk strategies,” they said. “Our work highlights key limitations of the ESC/ERS-based risk assessment, and suggests that incorporating measures of kidney function are important strategies moving forward,” they concluded.
Mr. Zelt is an MD/PhD student and had no financial conflicts to disclose. Some coauthors disclosed relationships with Actelion Pharmaceuticals, Bayer Pharmaceuticals, and Northern Therapeutics.
SOURCE: Zelt JGE et al. J Heart Lung Transplant. 2020 Apr 5. doi: 10.1016/j.healun.2020.03.026.
FROM THE JOURNAL OF HEART AND LUNG TRANSPLANTATION
AHA emphasizes the need for cardio-obstetrics teams
according to a statement from the American Heart Association.
Cardiovascular disease (CVD) remains the leading cause of pregnancy-related mortality in the United States, and accounted for approximately 17 deaths per 100,000 live births in 2015, wrote Laxmi S. Mehta, MD, of The Ohio State University, Columbus, and colleagues.
Ideally, a woman with CVD at the time of pregnancy should be managed by a multidisciplinary cardio-obstetrics team that can assess cardiovascular risk, obstetric risk, and fetal risk throughout pregnancy, delivery, and up to a year post partum. The team should develop a shared strategy to promote best outcomes, according to the statement. The cardio-obstetrics team may include obstetricians, cardiologists, anesthesiologists, maternal-fetal medicine specialists, geneticists, neurologists, nurses, and pharmacists, according to the statement.
Women with preexisting CVD should receive counseling about maternal and fetal risks before conception, if possible, to involve the women in shared decision-making and to develop strategies for each stage of pregnancy and delivery, Dr. Mehta and associates said. Such counseling should include a review of all medications and assessment of risk factors.
However, some women present already in the early stages of pregnancy even with severe conditions such as pulmonary arterial hypertension, severe ventricular dysfunction, severe left-sided heart obstruction, and significant aortic dilatation with underlying connective tissue disease. Women with these conditions often are counseled to avoid pregnancy, but if they already are pregnant, a high-risk cardio-obstetrics team will need to work together to discover the best strategies going forward to mitigate risk, Dr. Mehta and associates said.
Common CVD conditions that affect pregnancy include hypertensive disorders, notably preeclampsia, defined as systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg in women after 20 weeks of gestation whose blood pressure was normal prior to pregnancy. A management strategy to reduce the risk of pregnancy-related complications from hypertension includes healthy lifestyle behaviors such as exercise, nutrition, and smoking cessation, according to the statement. However, patients with severe hypertension may require intravenous labetalol or hydralazine. The statement gives more information about handling preeclampsia with pulmonary edema, and prevention of eclampsia and treatment of seizures.
It is important to recognize that severe hypertension or superimposed preeclampsia may occur for the first time post partum. Early ambulatory visits in the first 1-2 weeks are sensible. Medications may be needed to keep a systolic blood pressure not higher than 150 mm Hg and a diastolic blood pressure not higher than 100 mm Hg, Dr. Mehta and associates said.
According to the statement, severe hypertriglyceridemia and familial hypercholesterolemia are the two most common conditions in which lipids should be addressed during pregnancy, with consideration of the fetal risks associated with certain medications.
“Statins are contraindicated during pregnancy, and all women who are on any lipid-lowering agents should review with their physician the safety of treatment during pregnancy and whether to discontinue treatment before pregnancy,” according to the statement. A heart-healthy lifestyle can help improve lipid profiles in all pregnant patients, Dr. Mehta and associates said. Patients with extremely high triglycerides above 500 mg/dL are at risk of pancreatitis and “may benefit from pharmacological agents (omega-3 fatty acids with or without fenofibrate or gemfibrozil) during the second trimester,” they noted. Pregnant women with familial hypercholesterolemia might take bile acid sequestrants, or as a last resort, low-density lipoprotein apheresis.
Other conditions calling for a multidisciplinary cardio-obstetric approach include preexisting coronary artery disease, cardiomyopathies, arrhythmias, valvular heart disease, cerebrovascular disease, and deep venous thrombosis, according to the statement, which provides information about the risks, diagnosis, and management.
When it is time for delivery, spontaneous labor and vaginal birth are preferable for most women with heart disease, as cesarean delivery is associated with increased risk of infection, thrombotic complications, and blood loss, according to the statement.
Women with CVD and associated complications will require “specialized long-term cardiovascular follow-up,” Dr. Mehta and associates said. “In women with a high-risk pregnancy, a cardio-obstetrics team is essential to prevent maternal morbidity and mortality during the length of the pregnancy and post partum.”
“The release of this document demonstrates the AHA’s recognition of the importance of CVD in pregnancy-related death and their commitment to education and ensuring best practices in this field,” said Lisa M. Hollier, MD, past president of the American College of Obstetricians and Gynecologists and chief medical officer at Texas Children’s Health Plan, Bellaire.
“I think one of the most important outcomes from the release of this scientific statement from AHA will be increased implementation of cardio-obstetrics teams,” she said in an interview.
“In the United States, cardiovascular disease and cardiomyopathy together are now the leading cause of death in pregnancy and the postpartum period, and constitute 26.5% of pregnancy-related deaths, with higher rates of mortality among women of color and women with lower incomes,” she said. “The rising trend in cardiovascular-related maternal deaths appears to be due to acquired, not congenital, heart disease.”
During her tenure as president of ACOG, Dr. Hollier convened a task force on cardiovascular disease in pregnancy that developed guidance that outlines screening, diagnosis, and management of CVD for women from prepregnancy through post partum.
Dr. Hollier noted that COVID-19 emphasizes racial disparities for maternal mortality.
“Pregnant patients with comorbidities, like heart conditions, may be at increased risk for severe illness from COVID-19 – consistent with the general population with similar comorbidities,” she said. “And as we know, black women’s risk of dying from CVD-related pregnancy complications is 3.4 times higher than that of white women. During the COVID-19 pandemic, we are seeing these racial health disparities exacerbated.”
However, any pregnant patients should not hesitate to communicate with their health care providers despite the pandemic situation, Dr. Hollier emphasized. “Communication between a patient and her ob.gyn., cardiologist, or other clinician is even more critical now during the COVID-19 pandemic. We’re hearing reports that patients who are experiencing symptoms or those with known cardiac conditions are avoiding the hospital and delaying or not seeking necessary treatment. This has the very real possibility of worsening the devastating maternal mortality crisis that we’re already experiencing in this country.”
To help overcome barriers to treatment, “collaboration between ob.gyns. and cardiologists, such as the cardio-obstetrics team or pregnancy heart team, is critical,” said Dr. Hollier. “These collaborative teams with a multidisciplinary approach can prospectively reduce the communication gaps across specialties when patients are seen separately. They can also improve the communication during care transitions such as between outpatient and inpatient care.
“In reviews of maternal deaths, we have found that there are often delays in diagnosis of heart conditions during and after pregnancy,” Dr. Hollier added. “Most maternal deaths from CVD are due to either undiagnosed cardiovascular disease or new-onset cardiomyopathy. ACOG recommends that all women be assessed for cardiovascular disease in the antepartum and postpartum periods using a recently developed algorithm,” she said. “Women who have known CVD and women who have concerning symptoms should have a consultation with this team. With increased awareness and screening, women can receive the additional care that they need.
“Because management of cardiac conditions in pregnancy is so complex, it is important to ensure that women receive care with teams and in facilities that have appropriate resources,” explained Dr. Hollier. “Women with known heart disease should see a cardiologist prior to pregnancy and receive prepregnancy counseling,” as noted in the AHA statement. “Patients determined to have moderate and high-risk CVD should be managed during pregnancy, delivery, and post partum in a medical center that is able to provide a higher level of care, including a cardio-obstetrics team.”
Early recognition of cardiovascular conditions is essential to help manage care and reduce risks to mother and baby, said Dr. Hollier. “Identification before a woman becomes pregnant means the patient’s care can be properly managed throughout the pregnancy and a detailed delivery plan can be developed through shared decision making between the patient and provider. We must think of heart disease as a possibility in every pregnant or postpartum patient we see to detect and treat at-risk mothers,” she said.
Additional research should focus on identifying risk factors prior to pregnancy, said Dr. Hollier. “There are often delays in recognizing symptoms during pregnancy and post partum, particularly for black women. We need data to understand which protocols are best to identify heart disease,”
Dr. Hollier had no financial conflicts to disclose. The authors of the AHA statement had no financial conflicts to disclose. The scientific statement was produced on behalf of the American Heart Association Council on Clinical Cardiology; Council on Atherosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; and the Stroke Council.
SOURCE: Mehta LS et al. Circulation. 2020 May 4. doi: 10.1161/CIR.0000000000000772.
according to a statement from the American Heart Association.
Cardiovascular disease (CVD) remains the leading cause of pregnancy-related mortality in the United States, and accounted for approximately 17 deaths per 100,000 live births in 2015, wrote Laxmi S. Mehta, MD, of The Ohio State University, Columbus, and colleagues.
Ideally, a woman with CVD at the time of pregnancy should be managed by a multidisciplinary cardio-obstetrics team that can assess cardiovascular risk, obstetric risk, and fetal risk throughout pregnancy, delivery, and up to a year post partum. The team should develop a shared strategy to promote best outcomes, according to the statement. The cardio-obstetrics team may include obstetricians, cardiologists, anesthesiologists, maternal-fetal medicine specialists, geneticists, neurologists, nurses, and pharmacists, according to the statement.
Women with preexisting CVD should receive counseling about maternal and fetal risks before conception, if possible, to involve the women in shared decision-making and to develop strategies for each stage of pregnancy and delivery, Dr. Mehta and associates said. Such counseling should include a review of all medications and assessment of risk factors.
However, some women present already in the early stages of pregnancy even with severe conditions such as pulmonary arterial hypertension, severe ventricular dysfunction, severe left-sided heart obstruction, and significant aortic dilatation with underlying connective tissue disease. Women with these conditions often are counseled to avoid pregnancy, but if they already are pregnant, a high-risk cardio-obstetrics team will need to work together to discover the best strategies going forward to mitigate risk, Dr. Mehta and associates said.
Common CVD conditions that affect pregnancy include hypertensive disorders, notably preeclampsia, defined as systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg in women after 20 weeks of gestation whose blood pressure was normal prior to pregnancy. A management strategy to reduce the risk of pregnancy-related complications from hypertension includes healthy lifestyle behaviors such as exercise, nutrition, and smoking cessation, according to the statement. However, patients with severe hypertension may require intravenous labetalol or hydralazine. The statement gives more information about handling preeclampsia with pulmonary edema, and prevention of eclampsia and treatment of seizures.
It is important to recognize that severe hypertension or superimposed preeclampsia may occur for the first time post partum. Early ambulatory visits in the first 1-2 weeks are sensible. Medications may be needed to keep a systolic blood pressure not higher than 150 mm Hg and a diastolic blood pressure not higher than 100 mm Hg, Dr. Mehta and associates said.
According to the statement, severe hypertriglyceridemia and familial hypercholesterolemia are the two most common conditions in which lipids should be addressed during pregnancy, with consideration of the fetal risks associated with certain medications.
“Statins are contraindicated during pregnancy, and all women who are on any lipid-lowering agents should review with their physician the safety of treatment during pregnancy and whether to discontinue treatment before pregnancy,” according to the statement. A heart-healthy lifestyle can help improve lipid profiles in all pregnant patients, Dr. Mehta and associates said. Patients with extremely high triglycerides above 500 mg/dL are at risk of pancreatitis and “may benefit from pharmacological agents (omega-3 fatty acids with or without fenofibrate or gemfibrozil) during the second trimester,” they noted. Pregnant women with familial hypercholesterolemia might take bile acid sequestrants, or as a last resort, low-density lipoprotein apheresis.
Other conditions calling for a multidisciplinary cardio-obstetric approach include preexisting coronary artery disease, cardiomyopathies, arrhythmias, valvular heart disease, cerebrovascular disease, and deep venous thrombosis, according to the statement, which provides information about the risks, diagnosis, and management.
When it is time for delivery, spontaneous labor and vaginal birth are preferable for most women with heart disease, as cesarean delivery is associated with increased risk of infection, thrombotic complications, and blood loss, according to the statement.
Women with CVD and associated complications will require “specialized long-term cardiovascular follow-up,” Dr. Mehta and associates said. “In women with a high-risk pregnancy, a cardio-obstetrics team is essential to prevent maternal morbidity and mortality during the length of the pregnancy and post partum.”
“The release of this document demonstrates the AHA’s recognition of the importance of CVD in pregnancy-related death and their commitment to education and ensuring best practices in this field,” said Lisa M. Hollier, MD, past president of the American College of Obstetricians and Gynecologists and chief medical officer at Texas Children’s Health Plan, Bellaire.
“I think one of the most important outcomes from the release of this scientific statement from AHA will be increased implementation of cardio-obstetrics teams,” she said in an interview.
“In the United States, cardiovascular disease and cardiomyopathy together are now the leading cause of death in pregnancy and the postpartum period, and constitute 26.5% of pregnancy-related deaths, with higher rates of mortality among women of color and women with lower incomes,” she said. “The rising trend in cardiovascular-related maternal deaths appears to be due to acquired, not congenital, heart disease.”
During her tenure as president of ACOG, Dr. Hollier convened a task force on cardiovascular disease in pregnancy that developed guidance that outlines screening, diagnosis, and management of CVD for women from prepregnancy through post partum.
Dr. Hollier noted that COVID-19 emphasizes racial disparities for maternal mortality.
“Pregnant patients with comorbidities, like heart conditions, may be at increased risk for severe illness from COVID-19 – consistent with the general population with similar comorbidities,” she said. “And as we know, black women’s risk of dying from CVD-related pregnancy complications is 3.4 times higher than that of white women. During the COVID-19 pandemic, we are seeing these racial health disparities exacerbated.”
However, any pregnant patients should not hesitate to communicate with their health care providers despite the pandemic situation, Dr. Hollier emphasized. “Communication between a patient and her ob.gyn., cardiologist, or other clinician is even more critical now during the COVID-19 pandemic. We’re hearing reports that patients who are experiencing symptoms or those with known cardiac conditions are avoiding the hospital and delaying or not seeking necessary treatment. This has the very real possibility of worsening the devastating maternal mortality crisis that we’re already experiencing in this country.”
To help overcome barriers to treatment, “collaboration between ob.gyns. and cardiologists, such as the cardio-obstetrics team or pregnancy heart team, is critical,” said Dr. Hollier. “These collaborative teams with a multidisciplinary approach can prospectively reduce the communication gaps across specialties when patients are seen separately. They can also improve the communication during care transitions such as between outpatient and inpatient care.
“In reviews of maternal deaths, we have found that there are often delays in diagnosis of heart conditions during and after pregnancy,” Dr. Hollier added. “Most maternal deaths from CVD are due to either undiagnosed cardiovascular disease or new-onset cardiomyopathy. ACOG recommends that all women be assessed for cardiovascular disease in the antepartum and postpartum periods using a recently developed algorithm,” she said. “Women who have known CVD and women who have concerning symptoms should have a consultation with this team. With increased awareness and screening, women can receive the additional care that they need.
“Because management of cardiac conditions in pregnancy is so complex, it is important to ensure that women receive care with teams and in facilities that have appropriate resources,” explained Dr. Hollier. “Women with known heart disease should see a cardiologist prior to pregnancy and receive prepregnancy counseling,” as noted in the AHA statement. “Patients determined to have moderate and high-risk CVD should be managed during pregnancy, delivery, and post partum in a medical center that is able to provide a higher level of care, including a cardio-obstetrics team.”
Early recognition of cardiovascular conditions is essential to help manage care and reduce risks to mother and baby, said Dr. Hollier. “Identification before a woman becomes pregnant means the patient’s care can be properly managed throughout the pregnancy and a detailed delivery plan can be developed through shared decision making between the patient and provider. We must think of heart disease as a possibility in every pregnant or postpartum patient we see to detect and treat at-risk mothers,” she said.
Additional research should focus on identifying risk factors prior to pregnancy, said Dr. Hollier. “There are often delays in recognizing symptoms during pregnancy and post partum, particularly for black women. We need data to understand which protocols are best to identify heart disease,”
Dr. Hollier had no financial conflicts to disclose. The authors of the AHA statement had no financial conflicts to disclose. The scientific statement was produced on behalf of the American Heart Association Council on Clinical Cardiology; Council on Atherosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; and the Stroke Council.
SOURCE: Mehta LS et al. Circulation. 2020 May 4. doi: 10.1161/CIR.0000000000000772.
according to a statement from the American Heart Association.
Cardiovascular disease (CVD) remains the leading cause of pregnancy-related mortality in the United States, and accounted for approximately 17 deaths per 100,000 live births in 2015, wrote Laxmi S. Mehta, MD, of The Ohio State University, Columbus, and colleagues.
Ideally, a woman with CVD at the time of pregnancy should be managed by a multidisciplinary cardio-obstetrics team that can assess cardiovascular risk, obstetric risk, and fetal risk throughout pregnancy, delivery, and up to a year post partum. The team should develop a shared strategy to promote best outcomes, according to the statement. The cardio-obstetrics team may include obstetricians, cardiologists, anesthesiologists, maternal-fetal medicine specialists, geneticists, neurologists, nurses, and pharmacists, according to the statement.
Women with preexisting CVD should receive counseling about maternal and fetal risks before conception, if possible, to involve the women in shared decision-making and to develop strategies for each stage of pregnancy and delivery, Dr. Mehta and associates said. Such counseling should include a review of all medications and assessment of risk factors.
However, some women present already in the early stages of pregnancy even with severe conditions such as pulmonary arterial hypertension, severe ventricular dysfunction, severe left-sided heart obstruction, and significant aortic dilatation with underlying connective tissue disease. Women with these conditions often are counseled to avoid pregnancy, but if they already are pregnant, a high-risk cardio-obstetrics team will need to work together to discover the best strategies going forward to mitigate risk, Dr. Mehta and associates said.
Common CVD conditions that affect pregnancy include hypertensive disorders, notably preeclampsia, defined as systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg in women after 20 weeks of gestation whose blood pressure was normal prior to pregnancy. A management strategy to reduce the risk of pregnancy-related complications from hypertension includes healthy lifestyle behaviors such as exercise, nutrition, and smoking cessation, according to the statement. However, patients with severe hypertension may require intravenous labetalol or hydralazine. The statement gives more information about handling preeclampsia with pulmonary edema, and prevention of eclampsia and treatment of seizures.
It is important to recognize that severe hypertension or superimposed preeclampsia may occur for the first time post partum. Early ambulatory visits in the first 1-2 weeks are sensible. Medications may be needed to keep a systolic blood pressure not higher than 150 mm Hg and a diastolic blood pressure not higher than 100 mm Hg, Dr. Mehta and associates said.
According to the statement, severe hypertriglyceridemia and familial hypercholesterolemia are the two most common conditions in which lipids should be addressed during pregnancy, with consideration of the fetal risks associated with certain medications.
“Statins are contraindicated during pregnancy, and all women who are on any lipid-lowering agents should review with their physician the safety of treatment during pregnancy and whether to discontinue treatment before pregnancy,” according to the statement. A heart-healthy lifestyle can help improve lipid profiles in all pregnant patients, Dr. Mehta and associates said. Patients with extremely high triglycerides above 500 mg/dL are at risk of pancreatitis and “may benefit from pharmacological agents (omega-3 fatty acids with or without fenofibrate or gemfibrozil) during the second trimester,” they noted. Pregnant women with familial hypercholesterolemia might take bile acid sequestrants, or as a last resort, low-density lipoprotein apheresis.
Other conditions calling for a multidisciplinary cardio-obstetric approach include preexisting coronary artery disease, cardiomyopathies, arrhythmias, valvular heart disease, cerebrovascular disease, and deep venous thrombosis, according to the statement, which provides information about the risks, diagnosis, and management.
When it is time for delivery, spontaneous labor and vaginal birth are preferable for most women with heart disease, as cesarean delivery is associated with increased risk of infection, thrombotic complications, and blood loss, according to the statement.
Women with CVD and associated complications will require “specialized long-term cardiovascular follow-up,” Dr. Mehta and associates said. “In women with a high-risk pregnancy, a cardio-obstetrics team is essential to prevent maternal morbidity and mortality during the length of the pregnancy and post partum.”
“The release of this document demonstrates the AHA’s recognition of the importance of CVD in pregnancy-related death and their commitment to education and ensuring best practices in this field,” said Lisa M. Hollier, MD, past president of the American College of Obstetricians and Gynecologists and chief medical officer at Texas Children’s Health Plan, Bellaire.
“I think one of the most important outcomes from the release of this scientific statement from AHA will be increased implementation of cardio-obstetrics teams,” she said in an interview.
“In the United States, cardiovascular disease and cardiomyopathy together are now the leading cause of death in pregnancy and the postpartum period, and constitute 26.5% of pregnancy-related deaths, with higher rates of mortality among women of color and women with lower incomes,” she said. “The rising trend in cardiovascular-related maternal deaths appears to be due to acquired, not congenital, heart disease.”
During her tenure as president of ACOG, Dr. Hollier convened a task force on cardiovascular disease in pregnancy that developed guidance that outlines screening, diagnosis, and management of CVD for women from prepregnancy through post partum.
Dr. Hollier noted that COVID-19 emphasizes racial disparities for maternal mortality.
“Pregnant patients with comorbidities, like heart conditions, may be at increased risk for severe illness from COVID-19 – consistent with the general population with similar comorbidities,” she said. “And as we know, black women’s risk of dying from CVD-related pregnancy complications is 3.4 times higher than that of white women. During the COVID-19 pandemic, we are seeing these racial health disparities exacerbated.”
However, any pregnant patients should not hesitate to communicate with their health care providers despite the pandemic situation, Dr. Hollier emphasized. “Communication between a patient and her ob.gyn., cardiologist, or other clinician is even more critical now during the COVID-19 pandemic. We’re hearing reports that patients who are experiencing symptoms or those with known cardiac conditions are avoiding the hospital and delaying or not seeking necessary treatment. This has the very real possibility of worsening the devastating maternal mortality crisis that we’re already experiencing in this country.”
To help overcome barriers to treatment, “collaboration between ob.gyns. and cardiologists, such as the cardio-obstetrics team or pregnancy heart team, is critical,” said Dr. Hollier. “These collaborative teams with a multidisciplinary approach can prospectively reduce the communication gaps across specialties when patients are seen separately. They can also improve the communication during care transitions such as between outpatient and inpatient care.
“In reviews of maternal deaths, we have found that there are often delays in diagnosis of heart conditions during and after pregnancy,” Dr. Hollier added. “Most maternal deaths from CVD are due to either undiagnosed cardiovascular disease or new-onset cardiomyopathy. ACOG recommends that all women be assessed for cardiovascular disease in the antepartum and postpartum periods using a recently developed algorithm,” she said. “Women who have known CVD and women who have concerning symptoms should have a consultation with this team. With increased awareness and screening, women can receive the additional care that they need.
“Because management of cardiac conditions in pregnancy is so complex, it is important to ensure that women receive care with teams and in facilities that have appropriate resources,” explained Dr. Hollier. “Women with known heart disease should see a cardiologist prior to pregnancy and receive prepregnancy counseling,” as noted in the AHA statement. “Patients determined to have moderate and high-risk CVD should be managed during pregnancy, delivery, and post partum in a medical center that is able to provide a higher level of care, including a cardio-obstetrics team.”
Early recognition of cardiovascular conditions is essential to help manage care and reduce risks to mother and baby, said Dr. Hollier. “Identification before a woman becomes pregnant means the patient’s care can be properly managed throughout the pregnancy and a detailed delivery plan can be developed through shared decision making between the patient and provider. We must think of heart disease as a possibility in every pregnant or postpartum patient we see to detect and treat at-risk mothers,” she said.
Additional research should focus on identifying risk factors prior to pregnancy, said Dr. Hollier. “There are often delays in recognizing symptoms during pregnancy and post partum, particularly for black women. We need data to understand which protocols are best to identify heart disease,”
Dr. Hollier had no financial conflicts to disclose. The authors of the AHA statement had no financial conflicts to disclose. The scientific statement was produced on behalf of the American Heart Association Council on Clinical Cardiology; Council on Atherosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; and the Stroke Council.
SOURCE: Mehta LS et al. Circulation. 2020 May 4. doi: 10.1161/CIR.0000000000000772.
FROM CIRCULATION
Sleep quality may affect COPD risk in African American smokers
African American smokers who logged more total sleep time and greater sleep efficacy performed better on a functional walk test than did those with poorer sleep, based on data from 209 adults.
African American smokers tend to develop COPD sooner and also report more sleep problems, compared with white smokers, wrote Andrew J. Gangemi, MD, of Temple University Hospital, Philadelphia, and colleagues.
In addition, African Americans tend to develop COPD at a younger age and with lower levels of smoking than do non-Hispanic whites, they said. “Sleep health may be a contributing factor to the lung and cardiovascular health disparity experienced by AA smokers,” in part because data suggest that insufficient sleep may be associated with increased risk of COPD exacerbation in smokers in general, they said.
In a study published in Chest, the researchers reviewed data from 209 African American adults aged 40-65 years who had smoked at least one cigarette in the past month. The average age of the participants was 55 years, 59% were women, and the average smoking habit was nine cigarettes per day.
The researchers measured functional exercise capacity of the participants using the 6-minute walk test (6MWT). Total sleep time (TST) and sleep efficacy (SE) were measured by way of a finger-based device.
Smokers of at least 10 cigarettes per day gained an additional 0.05-0.58 meters in distance covered on the 6MWT for every added minute of total sleep time in a multivariable regression analysis. Similarly, smokers of at least 10 cigarettes per day gained an additional 0.84-6.17–meter increase in distance covered on the 6MWT for every added percentage of sleep efficacy.
The reasons for the impact of SE and TST on functional exercise capacity in smokers remain unclear, the researchers said. “Heavier smokers have higher levels of autonomic imbalance, including higher resting heart rate and heart rate variability, impaired 24-hour cardiovascular sympathetic tone, and blunted cerebrovascular autonomic regulation and baroreflex response to hypercapnia,” they said.
Also unclear is the reason for the large magnitude of the association between SE and smoking vs. the lesser association between TST and smoking on 6MWT results, the researchers wrote. “Poor sleep efficiency, outside of traditional OSA scoring, is predictive of myocardial infarction, stroke, and cardiovascular-related mortality risk. Moreover, deficits in sleep efficiency have been consistently demonstrated in smokers versus nonsmokers,” they said.
The study findings were limited by several factors including inability to extrapolate data to other demographic groups and the cross-sectional design, the researchers noted. In addition, they did not address how TST and SE may relate to lung function.
However, the results “extend current knowledge about the potential role of improved sleep health to functional exercise capacity in AA smokers,” and set the stage for future studies of how changes in sleep health may affect lung and functional exercise capacity in smokers over time, as well as effects on inflammation and autonomic imbalance, the researchers concluded.
The study was supported by the National Institute on Minority Health and Health Disparities and by the National Institute of General Medical Sciences, both part of the National Institutes Health. The researchers had no financial conflicts to disclose.
SOURCE: Gangemi A et al. Chest 2020 Apr 23. doi: 10.1016/j.chest.2020.03.070.
African American smokers who logged more total sleep time and greater sleep efficacy performed better on a functional walk test than did those with poorer sleep, based on data from 209 adults.
African American smokers tend to develop COPD sooner and also report more sleep problems, compared with white smokers, wrote Andrew J. Gangemi, MD, of Temple University Hospital, Philadelphia, and colleagues.
In addition, African Americans tend to develop COPD at a younger age and with lower levels of smoking than do non-Hispanic whites, they said. “Sleep health may be a contributing factor to the lung and cardiovascular health disparity experienced by AA smokers,” in part because data suggest that insufficient sleep may be associated with increased risk of COPD exacerbation in smokers in general, they said.
In a study published in Chest, the researchers reviewed data from 209 African American adults aged 40-65 years who had smoked at least one cigarette in the past month. The average age of the participants was 55 years, 59% were women, and the average smoking habit was nine cigarettes per day.
The researchers measured functional exercise capacity of the participants using the 6-minute walk test (6MWT). Total sleep time (TST) and sleep efficacy (SE) were measured by way of a finger-based device.
Smokers of at least 10 cigarettes per day gained an additional 0.05-0.58 meters in distance covered on the 6MWT for every added minute of total sleep time in a multivariable regression analysis. Similarly, smokers of at least 10 cigarettes per day gained an additional 0.84-6.17–meter increase in distance covered on the 6MWT for every added percentage of sleep efficacy.
The reasons for the impact of SE and TST on functional exercise capacity in smokers remain unclear, the researchers said. “Heavier smokers have higher levels of autonomic imbalance, including higher resting heart rate and heart rate variability, impaired 24-hour cardiovascular sympathetic tone, and blunted cerebrovascular autonomic regulation and baroreflex response to hypercapnia,” they said.
Also unclear is the reason for the large magnitude of the association between SE and smoking vs. the lesser association between TST and smoking on 6MWT results, the researchers wrote. “Poor sleep efficiency, outside of traditional OSA scoring, is predictive of myocardial infarction, stroke, and cardiovascular-related mortality risk. Moreover, deficits in sleep efficiency have been consistently demonstrated in smokers versus nonsmokers,” they said.
The study findings were limited by several factors including inability to extrapolate data to other demographic groups and the cross-sectional design, the researchers noted. In addition, they did not address how TST and SE may relate to lung function.
However, the results “extend current knowledge about the potential role of improved sleep health to functional exercise capacity in AA smokers,” and set the stage for future studies of how changes in sleep health may affect lung and functional exercise capacity in smokers over time, as well as effects on inflammation and autonomic imbalance, the researchers concluded.
The study was supported by the National Institute on Minority Health and Health Disparities and by the National Institute of General Medical Sciences, both part of the National Institutes Health. The researchers had no financial conflicts to disclose.
SOURCE: Gangemi A et al. Chest 2020 Apr 23. doi: 10.1016/j.chest.2020.03.070.
African American smokers who logged more total sleep time and greater sleep efficacy performed better on a functional walk test than did those with poorer sleep, based on data from 209 adults.
African American smokers tend to develop COPD sooner and also report more sleep problems, compared with white smokers, wrote Andrew J. Gangemi, MD, of Temple University Hospital, Philadelphia, and colleagues.
In addition, African Americans tend to develop COPD at a younger age and with lower levels of smoking than do non-Hispanic whites, they said. “Sleep health may be a contributing factor to the lung and cardiovascular health disparity experienced by AA smokers,” in part because data suggest that insufficient sleep may be associated with increased risk of COPD exacerbation in smokers in general, they said.
In a study published in Chest, the researchers reviewed data from 209 African American adults aged 40-65 years who had smoked at least one cigarette in the past month. The average age of the participants was 55 years, 59% were women, and the average smoking habit was nine cigarettes per day.
The researchers measured functional exercise capacity of the participants using the 6-minute walk test (6MWT). Total sleep time (TST) and sleep efficacy (SE) were measured by way of a finger-based device.
Smokers of at least 10 cigarettes per day gained an additional 0.05-0.58 meters in distance covered on the 6MWT for every added minute of total sleep time in a multivariable regression analysis. Similarly, smokers of at least 10 cigarettes per day gained an additional 0.84-6.17–meter increase in distance covered on the 6MWT for every added percentage of sleep efficacy.
The reasons for the impact of SE and TST on functional exercise capacity in smokers remain unclear, the researchers said. “Heavier smokers have higher levels of autonomic imbalance, including higher resting heart rate and heart rate variability, impaired 24-hour cardiovascular sympathetic tone, and blunted cerebrovascular autonomic regulation and baroreflex response to hypercapnia,” they said.
Also unclear is the reason for the large magnitude of the association between SE and smoking vs. the lesser association between TST and smoking on 6MWT results, the researchers wrote. “Poor sleep efficiency, outside of traditional OSA scoring, is predictive of myocardial infarction, stroke, and cardiovascular-related mortality risk. Moreover, deficits in sleep efficiency have been consistently demonstrated in smokers versus nonsmokers,” they said.
The study findings were limited by several factors including inability to extrapolate data to other demographic groups and the cross-sectional design, the researchers noted. In addition, they did not address how TST and SE may relate to lung function.
However, the results “extend current knowledge about the potential role of improved sleep health to functional exercise capacity in AA smokers,” and set the stage for future studies of how changes in sleep health may affect lung and functional exercise capacity in smokers over time, as well as effects on inflammation and autonomic imbalance, the researchers concluded.
The study was supported by the National Institute on Minority Health and Health Disparities and by the National Institute of General Medical Sciences, both part of the National Institutes Health. The researchers had no financial conflicts to disclose.
SOURCE: Gangemi A et al. Chest 2020 Apr 23. doi: 10.1016/j.chest.2020.03.070.
FROM CHEST
Adalimumab serum levels and anti-drug antibodies fail to predict responses to other TNFi
Both antiadalimumab (Humira) antibodies and adalimumab serum levels fell short on predicting drug responses in rheumatoid arthritis patients who failed initial adalimumab therapy, based on a retrospective cohort study of 137 adults.
Biologic disease-modifying antirheumatic drugs (bDMARDs), notably adalimumab, are often prescribed for RA, but “approximately 41% of RA patients do not achieve good response after 6 months of treatment with adalimumab,” wrote Evy Ulijn of Sint Maartenskliniek, Nijmegen, the Netherlands, and colleagues. Preliminary studies have suggested that antiadalimumab antibodies (antidrug antibodies, ADA) and adalimumab serum levels (ADL) may predict the response to a second bDMARD in patients who fail initial adalimumab treatment, they said.
In a study published in Annals of the Rheumatic Diseases, the researchers examined data from 137 adult RA patients seen at the clinic during Jan. 2012–Jan. 2018 who failed to respond to adalimumab after at least 3 months of treatment and started another bDMARD. The average age of the patients was 64 years, and approximately 69% were women.
Overall, the presence of ADA was not a significant predictor of a European League Against Rheumatism good response in patients who switched to another TNFi (etanercept, golimumab, infliximab, or certolizumab pegol), with sensitivity of 18% and specificity of 75%. ADA also was not predictive of response to a non-TNFi bDMARD (rituximab, tocilizumab, or abatacept), with sensitivity and specificity of 33% and 70%, respectively.
Similarly, ADL levels in patients who switched to a TNFi or non-TNFi were not significant predictors of treatment response, with sensitivities and specificities of 50% and 52%, respectively, for TNFi and 32% and 69%, respectively, for non-TNFi.
The findings that neither ADA nor ADL showed predictive values contrast with previous studies, the researchers said.
“Not only did the results of this study show no predictive values, in some analyses a prediction is found in the opposite direction of what was expected,” they wrote.
The study findings were limited by several factors, including the random timing of sample collection, retrospective study design, and potential for misclassification of responders or nonresponders, the researchers noted.
However, the results were strengthened by the blinded choice of treatment and outcome assessment, larger sample size than previous studies, and focus on adalimumab in particular, they said.
“While counterintuitive, it is hard to find an explanation for the lack of a positive finding,” they concluded.
More research is needed to confirm the predictive value of ADA and ADL, they said. In the meantime, rheumatologists should base decisions to switch patients to TNFi or non-TNFi treatment after adalimumab failure based on factors including side effects, local protocol, economical aspects, and patient preferences, they said.
The study received no external funding. The researchers had no financial conflicts to disclose.
SOURCE: Ulijn E et al. Ann Rheum Dis. 2020 Apr 21. doi: 10.1136/annrheumdis-2020-216996.
Both antiadalimumab (Humira) antibodies and adalimumab serum levels fell short on predicting drug responses in rheumatoid arthritis patients who failed initial adalimumab therapy, based on a retrospective cohort study of 137 adults.
Biologic disease-modifying antirheumatic drugs (bDMARDs), notably adalimumab, are often prescribed for RA, but “approximately 41% of RA patients do not achieve good response after 6 months of treatment with adalimumab,” wrote Evy Ulijn of Sint Maartenskliniek, Nijmegen, the Netherlands, and colleagues. Preliminary studies have suggested that antiadalimumab antibodies (antidrug antibodies, ADA) and adalimumab serum levels (ADL) may predict the response to a second bDMARD in patients who fail initial adalimumab treatment, they said.
In a study published in Annals of the Rheumatic Diseases, the researchers examined data from 137 adult RA patients seen at the clinic during Jan. 2012–Jan. 2018 who failed to respond to adalimumab after at least 3 months of treatment and started another bDMARD. The average age of the patients was 64 years, and approximately 69% were women.
Overall, the presence of ADA was not a significant predictor of a European League Against Rheumatism good response in patients who switched to another TNFi (etanercept, golimumab, infliximab, or certolizumab pegol), with sensitivity of 18% and specificity of 75%. ADA also was not predictive of response to a non-TNFi bDMARD (rituximab, tocilizumab, or abatacept), with sensitivity and specificity of 33% and 70%, respectively.
Similarly, ADL levels in patients who switched to a TNFi or non-TNFi were not significant predictors of treatment response, with sensitivities and specificities of 50% and 52%, respectively, for TNFi and 32% and 69%, respectively, for non-TNFi.
The findings that neither ADA nor ADL showed predictive values contrast with previous studies, the researchers said.
“Not only did the results of this study show no predictive values, in some analyses a prediction is found in the opposite direction of what was expected,” they wrote.
The study findings were limited by several factors, including the random timing of sample collection, retrospective study design, and potential for misclassification of responders or nonresponders, the researchers noted.
However, the results were strengthened by the blinded choice of treatment and outcome assessment, larger sample size than previous studies, and focus on adalimumab in particular, they said.
“While counterintuitive, it is hard to find an explanation for the lack of a positive finding,” they concluded.
More research is needed to confirm the predictive value of ADA and ADL, they said. In the meantime, rheumatologists should base decisions to switch patients to TNFi or non-TNFi treatment after adalimumab failure based on factors including side effects, local protocol, economical aspects, and patient preferences, they said.
The study received no external funding. The researchers had no financial conflicts to disclose.
SOURCE: Ulijn E et al. Ann Rheum Dis. 2020 Apr 21. doi: 10.1136/annrheumdis-2020-216996.
Both antiadalimumab (Humira) antibodies and adalimumab serum levels fell short on predicting drug responses in rheumatoid arthritis patients who failed initial adalimumab therapy, based on a retrospective cohort study of 137 adults.
Biologic disease-modifying antirheumatic drugs (bDMARDs), notably adalimumab, are often prescribed for RA, but “approximately 41% of RA patients do not achieve good response after 6 months of treatment with adalimumab,” wrote Evy Ulijn of Sint Maartenskliniek, Nijmegen, the Netherlands, and colleagues. Preliminary studies have suggested that antiadalimumab antibodies (antidrug antibodies, ADA) and adalimumab serum levels (ADL) may predict the response to a second bDMARD in patients who fail initial adalimumab treatment, they said.
In a study published in Annals of the Rheumatic Diseases, the researchers examined data from 137 adult RA patients seen at the clinic during Jan. 2012–Jan. 2018 who failed to respond to adalimumab after at least 3 months of treatment and started another bDMARD. The average age of the patients was 64 years, and approximately 69% were women.
Overall, the presence of ADA was not a significant predictor of a European League Against Rheumatism good response in patients who switched to another TNFi (etanercept, golimumab, infliximab, or certolizumab pegol), with sensitivity of 18% and specificity of 75%. ADA also was not predictive of response to a non-TNFi bDMARD (rituximab, tocilizumab, or abatacept), with sensitivity and specificity of 33% and 70%, respectively.
Similarly, ADL levels in patients who switched to a TNFi or non-TNFi were not significant predictors of treatment response, with sensitivities and specificities of 50% and 52%, respectively, for TNFi and 32% and 69%, respectively, for non-TNFi.
The findings that neither ADA nor ADL showed predictive values contrast with previous studies, the researchers said.
“Not only did the results of this study show no predictive values, in some analyses a prediction is found in the opposite direction of what was expected,” they wrote.
The study findings were limited by several factors, including the random timing of sample collection, retrospective study design, and potential for misclassification of responders or nonresponders, the researchers noted.
However, the results were strengthened by the blinded choice of treatment and outcome assessment, larger sample size than previous studies, and focus on adalimumab in particular, they said.
“While counterintuitive, it is hard to find an explanation for the lack of a positive finding,” they concluded.
More research is needed to confirm the predictive value of ADA and ADL, they said. In the meantime, rheumatologists should base decisions to switch patients to TNFi or non-TNFi treatment after adalimumab failure based on factors including side effects, local protocol, economical aspects, and patient preferences, they said.
The study received no external funding. The researchers had no financial conflicts to disclose.
SOURCE: Ulijn E et al. Ann Rheum Dis. 2020 Apr 21. doi: 10.1136/annrheumdis-2020-216996.
FROM ANNALS OF THE RHEUMATIC DISEASES
Postcesarean recovery protocols reduce opioid use
based on data from cohorts of women before and after the introduction of the protocols.
The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.
ERAS protocols have been introduced in surgical specialties including colorectal, urologic, gynecologic, and hepatobiliary – with noted benefits to patients and the health care system, wrote Nnamdi I. Gwacham, DO, of Saint Barnabas Medical Center, Livingston, N.J., and colleagues.
The researchers explored the impact of ERAS on reduction in opioid use after cesarean sections at a community teaching hospital in a retrospective study also published in Obstetrics & Gynecology.
The study population included a historical cohort of 2,109 patients from 2018 before the establishment of the ERAS pathway and 1,463 patients since the ERAS pathway was established in 2019.*
Significantly fewer patients in the ERAS group required opioids, compared with the historical group (1,766 vs. 341). A total of 8,082 opioid units were used before the introduction of the ERAS pathway, compared with 803 units used since its introduction, Dr. Gwacham and associates reported. The study was a Donald F. Richardson Prize Paper.
The ERAS pathway consisted of received transversus abdominis plane blocks in the immediate postoperative period (given to 98% of the patients), and all patients were started on “a scheduled multimodal analgesia with a combination of ibuprofen, acetaminophen, and dextromethorphan until discharge,” the researchers wrote. Patients received opioids only if their pain was not well controlled with the ERAS protocol.
In addition, patients who received ERAS had significantly shorter hospital stays than the historical group (3.19 days vs. 2.63 days) and incurred a significantly lower average direct cost ($4,290 vs. $3,957).
The groups were not significantly different in age, race, or body mass index.
“Given the current opioid epidemic in America, researching ways to reduce their use is an urgent matter,” Angela Martin, MD, of the University of Kansas, Kansas City, said in an interview.
She thought the study findings were to be expected based on research in other areas. “Given the trends and ability to reduced opioid use with ERAS in other specialties, it does not surprise me that women recovering from cesarean sections are similar.”
The take-home message for clinicians: “Begin thinking outside of the box when it comes to pain control,” emphasized Dr. Martin, who was not a part of this study. “Opioids don’t have to be the first line medications for postoperative pain management.”
She added that additional directions for research could include the patient perspective on postoperative pain management after a cesarean delivery. “Alternative options to opioids would be even more enticing if the inpatient experience was also improved,” said Dr. Martin, who is a member of the Ob.Gyn News editorial advisory board.
The researchers had no financial conflicts to disclose. Dr. Martin had no relevant financial disclosures.
SOURCE: Gwacham NI et al. Obstet Gynecol. 2020 May;135:2S. doi: 10.1097/01.AOG.0000662880.08512.6b.
*This article was updated on 4/29/2020.
based on data from cohorts of women before and after the introduction of the protocols.
The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.
ERAS protocols have been introduced in surgical specialties including colorectal, urologic, gynecologic, and hepatobiliary – with noted benefits to patients and the health care system, wrote Nnamdi I. Gwacham, DO, of Saint Barnabas Medical Center, Livingston, N.J., and colleagues.
The researchers explored the impact of ERAS on reduction in opioid use after cesarean sections at a community teaching hospital in a retrospective study also published in Obstetrics & Gynecology.
The study population included a historical cohort of 2,109 patients from 2018 before the establishment of the ERAS pathway and 1,463 patients since the ERAS pathway was established in 2019.*
Significantly fewer patients in the ERAS group required opioids, compared with the historical group (1,766 vs. 341). A total of 8,082 opioid units were used before the introduction of the ERAS pathway, compared with 803 units used since its introduction, Dr. Gwacham and associates reported. The study was a Donald F. Richardson Prize Paper.
The ERAS pathway consisted of received transversus abdominis plane blocks in the immediate postoperative period (given to 98% of the patients), and all patients were started on “a scheduled multimodal analgesia with a combination of ibuprofen, acetaminophen, and dextromethorphan until discharge,” the researchers wrote. Patients received opioids only if their pain was not well controlled with the ERAS protocol.
In addition, patients who received ERAS had significantly shorter hospital stays than the historical group (3.19 days vs. 2.63 days) and incurred a significantly lower average direct cost ($4,290 vs. $3,957).
The groups were not significantly different in age, race, or body mass index.
“Given the current opioid epidemic in America, researching ways to reduce their use is an urgent matter,” Angela Martin, MD, of the University of Kansas, Kansas City, said in an interview.
She thought the study findings were to be expected based on research in other areas. “Given the trends and ability to reduced opioid use with ERAS in other specialties, it does not surprise me that women recovering from cesarean sections are similar.”
The take-home message for clinicians: “Begin thinking outside of the box when it comes to pain control,” emphasized Dr. Martin, who was not a part of this study. “Opioids don’t have to be the first line medications for postoperative pain management.”
She added that additional directions for research could include the patient perspective on postoperative pain management after a cesarean delivery. “Alternative options to opioids would be even more enticing if the inpatient experience was also improved,” said Dr. Martin, who is a member of the Ob.Gyn News editorial advisory board.
The researchers had no financial conflicts to disclose. Dr. Martin had no relevant financial disclosures.
SOURCE: Gwacham NI et al. Obstet Gynecol. 2020 May;135:2S. doi: 10.1097/01.AOG.0000662880.08512.6b.
*This article was updated on 4/29/2020.
based on data from cohorts of women before and after the introduction of the protocols.
The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.
ERAS protocols have been introduced in surgical specialties including colorectal, urologic, gynecologic, and hepatobiliary – with noted benefits to patients and the health care system, wrote Nnamdi I. Gwacham, DO, of Saint Barnabas Medical Center, Livingston, N.J., and colleagues.
The researchers explored the impact of ERAS on reduction in opioid use after cesarean sections at a community teaching hospital in a retrospective study also published in Obstetrics & Gynecology.
The study population included a historical cohort of 2,109 patients from 2018 before the establishment of the ERAS pathway and 1,463 patients since the ERAS pathway was established in 2019.*
Significantly fewer patients in the ERAS group required opioids, compared with the historical group (1,766 vs. 341). A total of 8,082 opioid units were used before the introduction of the ERAS pathway, compared with 803 units used since its introduction, Dr. Gwacham and associates reported. The study was a Donald F. Richardson Prize Paper.
The ERAS pathway consisted of received transversus abdominis plane blocks in the immediate postoperative period (given to 98% of the patients), and all patients were started on “a scheduled multimodal analgesia with a combination of ibuprofen, acetaminophen, and dextromethorphan until discharge,” the researchers wrote. Patients received opioids only if their pain was not well controlled with the ERAS protocol.
In addition, patients who received ERAS had significantly shorter hospital stays than the historical group (3.19 days vs. 2.63 days) and incurred a significantly lower average direct cost ($4,290 vs. $3,957).
The groups were not significantly different in age, race, or body mass index.
“Given the current opioid epidemic in America, researching ways to reduce their use is an urgent matter,” Angela Martin, MD, of the University of Kansas, Kansas City, said in an interview.
She thought the study findings were to be expected based on research in other areas. “Given the trends and ability to reduced opioid use with ERAS in other specialties, it does not surprise me that women recovering from cesarean sections are similar.”
The take-home message for clinicians: “Begin thinking outside of the box when it comes to pain control,” emphasized Dr. Martin, who was not a part of this study. “Opioids don’t have to be the first line medications for postoperative pain management.”
She added that additional directions for research could include the patient perspective on postoperative pain management after a cesarean delivery. “Alternative options to opioids would be even more enticing if the inpatient experience was also improved,” said Dr. Martin, who is a member of the Ob.Gyn News editorial advisory board.
The researchers had no financial conflicts to disclose. Dr. Martin had no relevant financial disclosures.
SOURCE: Gwacham NI et al. Obstet Gynecol. 2020 May;135:2S. doi: 10.1097/01.AOG.0000662880.08512.6b.
*This article was updated on 4/29/2020.
REPORTING FROM ACOG 2020
N.Y. universal testing: Many COVID-19+ pregnant women are asymptomatic
based on data from 215 pregnant women in New York City.
“The obstetrical population presents a unique challenge during this pandemic, since these patients have multiple interactions with the health care system and eventually most are admitted to the hospital for delivery,” wrote Desmond Sutton, MD, and colleagues at Columbia University Irving Medical Center, New York
In a letter published in the New England Journal of Medicine, the researchers reviewed their experiences with 215 pregnant women who delivered infants during March 22–April 4, 2020, at the New York–Presbyterian Allen Hospital and Columbia University Irving Medical Center. All the women were screened for symptoms of the COVID-19 infection on admission.
Overall, four women (1.9%) had fevers or other symptoms on admission, and all of these women tested positive for the virus that causes COVID-19. The other 211 women were afebrile and asymptomatic at admission, and 210 of them were tested via nasopharyngeal swabs. A total of 29 asymptomatic women (13.7%) tested positive for COVID-19 infection.
“Thus, 29 of the 33 patients who were positive for SARS-CoV-2 at admission (87.9%) had no symptoms of COVID-19 at presentation,” Dr. Sutton and colleagues wrote.
Three of the 29 COVID-19-positive women who were asymptomatic on admission developed fevers before they were discharged from the hospital after a median stay of 2 days. Of these, two received antibiotics for presumed endomyometritis and one patient with presumed COVID-19 infection received supportive care. In addition, one patient who was initially negative developed COVID-19 symptoms after delivery and tested positive 3 days after her initial negative test.
“Our use of universal SARS-CoV-2 testing in all pregnant patients presenting for delivery revealed that at this point in the pandemic in New York City, most of the patients who were positive for SARS-CoV-2 at delivery were asymptomatic,” Dr. Sutton and colleagues said.
Although their numbers may not be generalizable to areas with lower infection rates, they highlight the risk of COVID-19 infection in asymptomatic pregnant women, they noted.
“The potential benefits of a universal testing approach include the ability to use COVID-19 status to determine hospital isolation practices and bed assignments, inform neonatal care, and guide the use of personal protective equipment,” they concluded.
Continuing challenges
“What I have seen in our institute is the debate about rapid testing and the inherent problems with false negatives and false positives,” Catherine Cansino, MD, of the University of California, Davis, said in an interview. “I think there is definitely a role for universal testing, especially in areas with high prevalence,” and the New York clinicians have made a strong case.
However, the challenge remains of obtaining quick test results that would still be reliable, as many rapid tests have a false-negative rate of as much as 20%, noted Dr. Cansino, who was not involved in the New York study.
Her institution is using a test with a higher level of accuracy, “but it can take several hours or a day to get the results,” at which point the women may have gone through labor and delivery and been in contact with multiple health care workers who have used personal protective equipment accordingly if they don’t know a patient’s status.
To help guide policies, Dr. Cansino said that outcome data would be useful. “It’s hard to know how outcomes are different, and it would be good to know how transmission rates differ between symptomatic carriers and those who are asymptomatic.”
“As SARS-CoV-2, the virus responsible for COVID-19, continues to spread, pregnant women remain a unique population with required frequent health system contacts and ultimate need for delivery,” Iris Krishna, MD, of the Emory Healthcare Network in Atlanta, said in an interview. “This report in a high prevalence area demonstrated 1 out of 8 asymptomatic pregnant patients presenting for delivery were SARS-CoV-2 positive, illustrating a need for universal screening.
“As this pandemic evolves, we are learning more and more, and it is important to expand our understanding of asymptomatic transmission and the risk this may pose,” said Dr. Krishna, who was not part of the New York study.
“Key benefits to universal screening are the capability for labor and delivery units to implement best hospital practices in their care of mothers and babies, such as admitting positive patients to cohort units,” she noted. Such units would “allow for closer monitoring of mothers and babies, as well as ensuring proper use of personal protective equipment by health care teams” and also would help preserve supplies of personal protective equipment.
Dr. Krishna cited hospital testing capacity as an obvious barrier to universal screening of pregnant women, as well as factors including the need for additional protective equipment to be used during swab collection. Also, “If you get a negative result and there is a strong suspicion for COVID-19 infection, when do you retest?” she asked. “These are key questions or areas of assessment that should be considered before embarking on universal screening for pregnant women.” In addition, some patients may refuse testing out of fear of stigma or separation from their newborn.
“Implementing an ‘opt out’ approach to screening is encouraged, whereby a patient is informed that a test will be included in standard preventive screening, and they may decline the test,” Dr. Krishna said. “Routine, opt-out screening approaches have proven to be highly effective as it removes the stigma associated with testing, fosters earlier diagnosis and treatment, reduces risk of transmission, and has proven to be cost effective. Pregnant women should be reassured that universal screening is beneficial for their care and the care of their newborn baby,” she emphasized.
“Institutions should consider implementing universal screening on labor and delivery as several geographic areas are predicted to reach their peak time of COVID-19 transmission, and it is clear that asymptomatic individuals continue to play a role in its transmission,” Dr. Krishna concluded.
Dr. Sutton and associates had no financial conflicts to disclose. Neither Dr. Cansino nor Dr. Krishna had any financial conflicts to disclose. Dr. Cansino and Dr. Krishna are members of the Ob.Gyn. News Editorial Advisory Board.
SOURCE: Sutton D et al. N Engl J Med. 2020 Apr 13. doi: 10.1056/NEJMc2009316.
based on data from 215 pregnant women in New York City.
“The obstetrical population presents a unique challenge during this pandemic, since these patients have multiple interactions with the health care system and eventually most are admitted to the hospital for delivery,” wrote Desmond Sutton, MD, and colleagues at Columbia University Irving Medical Center, New York
In a letter published in the New England Journal of Medicine, the researchers reviewed their experiences with 215 pregnant women who delivered infants during March 22–April 4, 2020, at the New York–Presbyterian Allen Hospital and Columbia University Irving Medical Center. All the women were screened for symptoms of the COVID-19 infection on admission.
Overall, four women (1.9%) had fevers or other symptoms on admission, and all of these women tested positive for the virus that causes COVID-19. The other 211 women were afebrile and asymptomatic at admission, and 210 of them were tested via nasopharyngeal swabs. A total of 29 asymptomatic women (13.7%) tested positive for COVID-19 infection.
“Thus, 29 of the 33 patients who were positive for SARS-CoV-2 at admission (87.9%) had no symptoms of COVID-19 at presentation,” Dr. Sutton and colleagues wrote.
Three of the 29 COVID-19-positive women who were asymptomatic on admission developed fevers before they were discharged from the hospital after a median stay of 2 days. Of these, two received antibiotics for presumed endomyometritis and one patient with presumed COVID-19 infection received supportive care. In addition, one patient who was initially negative developed COVID-19 symptoms after delivery and tested positive 3 days after her initial negative test.
“Our use of universal SARS-CoV-2 testing in all pregnant patients presenting for delivery revealed that at this point in the pandemic in New York City, most of the patients who were positive for SARS-CoV-2 at delivery were asymptomatic,” Dr. Sutton and colleagues said.
Although their numbers may not be generalizable to areas with lower infection rates, they highlight the risk of COVID-19 infection in asymptomatic pregnant women, they noted.
“The potential benefits of a universal testing approach include the ability to use COVID-19 status to determine hospital isolation practices and bed assignments, inform neonatal care, and guide the use of personal protective equipment,” they concluded.
Continuing challenges
“What I have seen in our institute is the debate about rapid testing and the inherent problems with false negatives and false positives,” Catherine Cansino, MD, of the University of California, Davis, said in an interview. “I think there is definitely a role for universal testing, especially in areas with high prevalence,” and the New York clinicians have made a strong case.
However, the challenge remains of obtaining quick test results that would still be reliable, as many rapid tests have a false-negative rate of as much as 20%, noted Dr. Cansino, who was not involved in the New York study.
Her institution is using a test with a higher level of accuracy, “but it can take several hours or a day to get the results,” at which point the women may have gone through labor and delivery and been in contact with multiple health care workers who have used personal protective equipment accordingly if they don’t know a patient’s status.
To help guide policies, Dr. Cansino said that outcome data would be useful. “It’s hard to know how outcomes are different, and it would be good to know how transmission rates differ between symptomatic carriers and those who are asymptomatic.”
“As SARS-CoV-2, the virus responsible for COVID-19, continues to spread, pregnant women remain a unique population with required frequent health system contacts and ultimate need for delivery,” Iris Krishna, MD, of the Emory Healthcare Network in Atlanta, said in an interview. “This report in a high prevalence area demonstrated 1 out of 8 asymptomatic pregnant patients presenting for delivery were SARS-CoV-2 positive, illustrating a need for universal screening.
“As this pandemic evolves, we are learning more and more, and it is important to expand our understanding of asymptomatic transmission and the risk this may pose,” said Dr. Krishna, who was not part of the New York study.
“Key benefits to universal screening are the capability for labor and delivery units to implement best hospital practices in their care of mothers and babies, such as admitting positive patients to cohort units,” she noted. Such units would “allow for closer monitoring of mothers and babies, as well as ensuring proper use of personal protective equipment by health care teams” and also would help preserve supplies of personal protective equipment.
Dr. Krishna cited hospital testing capacity as an obvious barrier to universal screening of pregnant women, as well as factors including the need for additional protective equipment to be used during swab collection. Also, “If you get a negative result and there is a strong suspicion for COVID-19 infection, when do you retest?” she asked. “These are key questions or areas of assessment that should be considered before embarking on universal screening for pregnant women.” In addition, some patients may refuse testing out of fear of stigma or separation from their newborn.
“Implementing an ‘opt out’ approach to screening is encouraged, whereby a patient is informed that a test will be included in standard preventive screening, and they may decline the test,” Dr. Krishna said. “Routine, opt-out screening approaches have proven to be highly effective as it removes the stigma associated with testing, fosters earlier diagnosis and treatment, reduces risk of transmission, and has proven to be cost effective. Pregnant women should be reassured that universal screening is beneficial for their care and the care of their newborn baby,” she emphasized.
“Institutions should consider implementing universal screening on labor and delivery as several geographic areas are predicted to reach their peak time of COVID-19 transmission, and it is clear that asymptomatic individuals continue to play a role in its transmission,” Dr. Krishna concluded.
Dr. Sutton and associates had no financial conflicts to disclose. Neither Dr. Cansino nor Dr. Krishna had any financial conflicts to disclose. Dr. Cansino and Dr. Krishna are members of the Ob.Gyn. News Editorial Advisory Board.
SOURCE: Sutton D et al. N Engl J Med. 2020 Apr 13. doi: 10.1056/NEJMc2009316.
based on data from 215 pregnant women in New York City.
“The obstetrical population presents a unique challenge during this pandemic, since these patients have multiple interactions with the health care system and eventually most are admitted to the hospital for delivery,” wrote Desmond Sutton, MD, and colleagues at Columbia University Irving Medical Center, New York
In a letter published in the New England Journal of Medicine, the researchers reviewed their experiences with 215 pregnant women who delivered infants during March 22–April 4, 2020, at the New York–Presbyterian Allen Hospital and Columbia University Irving Medical Center. All the women were screened for symptoms of the COVID-19 infection on admission.
Overall, four women (1.9%) had fevers or other symptoms on admission, and all of these women tested positive for the virus that causes COVID-19. The other 211 women were afebrile and asymptomatic at admission, and 210 of them were tested via nasopharyngeal swabs. A total of 29 asymptomatic women (13.7%) tested positive for COVID-19 infection.
“Thus, 29 of the 33 patients who were positive for SARS-CoV-2 at admission (87.9%) had no symptoms of COVID-19 at presentation,” Dr. Sutton and colleagues wrote.
Three of the 29 COVID-19-positive women who were asymptomatic on admission developed fevers before they were discharged from the hospital after a median stay of 2 days. Of these, two received antibiotics for presumed endomyometritis and one patient with presumed COVID-19 infection received supportive care. In addition, one patient who was initially negative developed COVID-19 symptoms after delivery and tested positive 3 days after her initial negative test.
“Our use of universal SARS-CoV-2 testing in all pregnant patients presenting for delivery revealed that at this point in the pandemic in New York City, most of the patients who were positive for SARS-CoV-2 at delivery were asymptomatic,” Dr. Sutton and colleagues said.
Although their numbers may not be generalizable to areas with lower infection rates, they highlight the risk of COVID-19 infection in asymptomatic pregnant women, they noted.
“The potential benefits of a universal testing approach include the ability to use COVID-19 status to determine hospital isolation practices and bed assignments, inform neonatal care, and guide the use of personal protective equipment,” they concluded.
Continuing challenges
“What I have seen in our institute is the debate about rapid testing and the inherent problems with false negatives and false positives,” Catherine Cansino, MD, of the University of California, Davis, said in an interview. “I think there is definitely a role for universal testing, especially in areas with high prevalence,” and the New York clinicians have made a strong case.
However, the challenge remains of obtaining quick test results that would still be reliable, as many rapid tests have a false-negative rate of as much as 20%, noted Dr. Cansino, who was not involved in the New York study.
Her institution is using a test with a higher level of accuracy, “but it can take several hours or a day to get the results,” at which point the women may have gone through labor and delivery and been in contact with multiple health care workers who have used personal protective equipment accordingly if they don’t know a patient’s status.
To help guide policies, Dr. Cansino said that outcome data would be useful. “It’s hard to know how outcomes are different, and it would be good to know how transmission rates differ between symptomatic carriers and those who are asymptomatic.”
“As SARS-CoV-2, the virus responsible for COVID-19, continues to spread, pregnant women remain a unique population with required frequent health system contacts and ultimate need for delivery,” Iris Krishna, MD, of the Emory Healthcare Network in Atlanta, said in an interview. “This report in a high prevalence area demonstrated 1 out of 8 asymptomatic pregnant patients presenting for delivery were SARS-CoV-2 positive, illustrating a need for universal screening.
“As this pandemic evolves, we are learning more and more, and it is important to expand our understanding of asymptomatic transmission and the risk this may pose,” said Dr. Krishna, who was not part of the New York study.
“Key benefits to universal screening are the capability for labor and delivery units to implement best hospital practices in their care of mothers and babies, such as admitting positive patients to cohort units,” she noted. Such units would “allow for closer monitoring of mothers and babies, as well as ensuring proper use of personal protective equipment by health care teams” and also would help preserve supplies of personal protective equipment.
Dr. Krishna cited hospital testing capacity as an obvious barrier to universal screening of pregnant women, as well as factors including the need for additional protective equipment to be used during swab collection. Also, “If you get a negative result and there is a strong suspicion for COVID-19 infection, when do you retest?” she asked. “These are key questions or areas of assessment that should be considered before embarking on universal screening for pregnant women.” In addition, some patients may refuse testing out of fear of stigma or separation from their newborn.
“Implementing an ‘opt out’ approach to screening is encouraged, whereby a patient is informed that a test will be included in standard preventive screening, and they may decline the test,” Dr. Krishna said. “Routine, opt-out screening approaches have proven to be highly effective as it removes the stigma associated with testing, fosters earlier diagnosis and treatment, reduces risk of transmission, and has proven to be cost effective. Pregnant women should be reassured that universal screening is beneficial for their care and the care of their newborn baby,” she emphasized.
“Institutions should consider implementing universal screening on labor and delivery as several geographic areas are predicted to reach their peak time of COVID-19 transmission, and it is clear that asymptomatic individuals continue to play a role in its transmission,” Dr. Krishna concluded.
Dr. Sutton and associates had no financial conflicts to disclose. Neither Dr. Cansino nor Dr. Krishna had any financial conflicts to disclose. Dr. Cansino and Dr. Krishna are members of the Ob.Gyn. News Editorial Advisory Board.
SOURCE: Sutton D et al. N Engl J Med. 2020 Apr 13. doi: 10.1056/NEJMc2009316.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Universal COVID-19 testing for pregnant women entering hospitals for delivery could better protect patients and staff.
Major finding: Approximately 88% of 33 pregnant women who tested positive for COVID-19 infection at hospital admission were asymptomatic; about 14% of the 215 women overall tested positive for the novel coronavirus.
Study details: The data come from a review of 215 pregnant women who delivered infants between March 22 and April 4, 2020, in New York City.
Disclosures: The authors had no financial conflicts to disclose.
Source: Sutton D et al. N Engl J Med. 2020 Apr 13. doi: 10.1056/NEJMc2009316.