Emergency Medicine

International Laboratories has initiated a voluntary recall to the consumer level in the United States of a single lot of the antiplatelet clopidogrel because it is mislabeled and may contain simvastatin, a cholesterol-lowering drug, instead of clopidogrel.

The recalled product ― lot number 117099A of clopidogrel tablets (USP 75 mg) packaged in bottles of 30 tablets ― may contain clopidogrel 75 mg tablets or it could contain simvastatin tablets (USP 10 mg), according to a company announcement posted on the US Food and Drug Administration (FDA) website.

“Missed doses of clopidogrel increases the risk of heart attack and stroke which can be life threatening. Additionally, unintentional consumption of simvastatin could include the common side effects associated with its use and may cause fetal harm when administered to a pregnant woman,” the company cautions.

To date, the company has not received any reports of harm arising from the problem that prompted the recall.

The recalled product was distributed nationwide and was delivered to distribution centers in Arkansas, Georgia, Indiana, California, and Maryland and to retail stores in all US states.

International Laboratories is notifying distributors and customers by letter and is arranging for the return of all recalled products.

For questions regarding this recall, contact Inmar by phone 855-258-7280 (weekdays between 9:00 AM and 5:00 PM EST) or by email at [email protected].

Adverse reactions or quality problems experienced with the use of this product should be reported to the FDA’s MedWatch adverse event reporting program.
 

This article first appeared on Medscape.com.

International Laboratories has initiated a voluntary recall to the consumer level in the United States of a single lot of the antiplatelet clopidogrel because it is mislabeled and may contain simvastatin, a cholesterol-lowering drug, instead of clopidogrel.

The recalled product ― lot number 117099A of clopidogrel tablets (USP 75 mg) packaged in bottles of 30 tablets ― may contain clopidogrel 75 mg tablets or it could contain simvastatin tablets (USP 10 mg), according to a company announcement posted on the US Food and Drug Administration (FDA) website.

“Missed doses of clopidogrel increases the risk of heart attack and stroke which can be life threatening. Additionally, unintentional consumption of simvastatin could include the common side effects associated with its use and may cause fetal harm when administered to a pregnant woman,” the company cautions.

To date, the company has not received any reports of harm arising from the problem that prompted the recall.

The recalled product was distributed nationwide and was delivered to distribution centers in Arkansas, Georgia, Indiana, California, and Maryland and to retail stores in all US states.

International Laboratories is notifying distributors and customers by letter and is arranging for the return of all recalled products.

For questions regarding this recall, contact Inmar by phone 855-258-7280 (weekdays between 9:00 AM and 5:00 PM EST) or by email at [email protected].

Adverse reactions or quality problems experienced with the use of this product should be reported to the FDA’s MedWatch adverse event reporting program.
 

This article first appeared on Medscape.com.

International Laboratories has initiated a voluntary recall to the consumer level in the United States of a single lot of the antiplatelet clopidogrel because it is mislabeled and may contain simvastatin, a cholesterol-lowering drug, instead of clopidogrel.

The recalled product ― lot number 117099A of clopidogrel tablets (USP 75 mg) packaged in bottles of 30 tablets ― may contain clopidogrel 75 mg tablets or it could contain simvastatin tablets (USP 10 mg), according to a company announcement posted on the US Food and Drug Administration (FDA) website.

“Missed doses of clopidogrel increases the risk of heart attack and stroke which can be life threatening. Additionally, unintentional consumption of simvastatin could include the common side effects associated with its use and may cause fetal harm when administered to a pregnant woman,” the company cautions.

To date, the company has not received any reports of harm arising from the problem that prompted the recall.

The recalled product was distributed nationwide and was delivered to distribution centers in Arkansas, Georgia, Indiana, California, and Maryland and to retail stores in all US states.

International Laboratories is notifying distributors and customers by letter and is arranging for the return of all recalled products.

For questions regarding this recall, contact Inmar by phone 855-258-7280 (weekdays between 9:00 AM and 5:00 PM EST) or by email at [email protected].

Adverse reactions or quality problems experienced with the use of this product should be reported to the FDA’s MedWatch adverse event reporting program.
 

This article first appeared on Medscape.com.

The American Society of Echocardiography (ASE) has issued a statement on protecting patients and echocardiography service providers during the COVID-19 pandemic.

Given the risk for cardiovascular complications associated with COVID-19, echocardiographic services will likely be needed for patients with suspected or confirmed COVID-19, meaning echo providers will be exposed to SARS-CoV-2, write the statement authors, led by James N. Kirkpatrick, MD, director of the echocardiography laboratory at University of Washington Medical Center in Seattle.

The statement was published online April 6 in the Journal of the American College of Cardiology.

The authors say the statement is intended to help guide the practice of echocardiography in this “challenging time.” It was developed with input from a variety of echocardiography providers and institutions who have experience with the COVID-19, or have been “actively and thoughtfully preparing for it.”

Who, When, Where, and How

The statement covers triaging and decision pathways for handling requests for echocardiography, as well as indications and recommended procedures, in cases of suspected or confirmed COVID-19.

Among the recommendations:

• Only perform transthoracic echocardiograms (TTE), stress echocardiograms, and transesophageal echocardiograms (TEE) if they are expected to provide clinical benefit. Appropriate-use criteria represent the first decision point as to whether an echocardiographic test should be performed.
• Determine which studies are “elective” and reschedule them, performing all others. Identify “nonelective” (urgent/emergent) indications and defer all others.
• Determine the clinical benefit of echocardiography for symptomatic patients whose SARS-CoV-2 status is unknown.
• Cautiously consider the benefit of a TEE examination weighed against the risk for exposure of healthcare personnel to aerosolization in a patient with suspected or confirmed COVID-19.
• Postpone or cancel TEEs if an alternative imaging modality can provide the necessary information.
• Note that treadmill or bicycle stress echo tests in patients with COVID-19 may lead to exposure because of deep breathing and/or coughing during exercise. These tests should generally be deferred or converted to a pharmacologic stress echo.
   

   

The ASE statement also provides advice on safe imaging protocol and adequate personal protection measures.

“In addition to limiting the number of echocardiography practitioners involved in scanning, consideration should be given to limiting the exposure of staff who may be particularly susceptible to severe complications of COVID-19,” the ASE advises.

Staff who are older than 60 years, who have chronic conditions, are immunocompromised or are pregnant may wish to avoid contact with patients suspected or confirmed to have COVID-19.

It’s also important to realize the risk for transmission in reading rooms. “Keyboards, monitors, mice, chairs, phones, desktops, and door knobs should be frequently cleaned, and ventilation provided wherever possible,” the ASE advises. When the echo lab reading room is located in a high-traffic area, remote review of images or via webinar might be advisable, they suggest.

Summing up, Kirkland and colleagues say providing echocardiographic service “remains crucial in this difficult time of the SARS-CoV-2 outbreak. Working together, we can continue to provide high-quality care while minimizing risk to ourselves, our patients, and the public at large. Carefully considering ‘Whom to Image’, ‘Where to Image’ and ‘How to Image’ has the potential to reduce the risks of transmission.”

The authors note that the statements and recommendations are primarily based on expert opinion rather than on scientifically verified data and are subject to change as the COVID-19 outbreak continues to evolve and new data emerges.
 

This article first appeared on Medscape.com.

The American Society of Echocardiography (ASE) has issued a statement on protecting patients and echocardiography service providers during the COVID-19 pandemic.

Given the risk for cardiovascular complications associated with COVID-19, echocardiographic services will likely be needed for patients with suspected or confirmed COVID-19, meaning echo providers will be exposed to SARS-CoV-2, write the statement authors, led by James N. Kirkpatrick, MD, director of the echocardiography laboratory at University of Washington Medical Center in Seattle.

The statement was published online April 6 in the Journal of the American College of Cardiology.

The authors say the statement is intended to help guide the practice of echocardiography in this “challenging time.” It was developed with input from a variety of echocardiography providers and institutions who have experience with the COVID-19, or have been “actively and thoughtfully preparing for it.”

Who, When, Where, and How

The statement covers triaging and decision pathways for handling requests for echocardiography, as well as indications and recommended procedures, in cases of suspected or confirmed COVID-19.

Among the recommendations:

• Only perform transthoracic echocardiograms (TTE), stress echocardiograms, and transesophageal echocardiograms (TEE) if they are expected to provide clinical benefit. Appropriate-use criteria represent the first decision point as to whether an echocardiographic test should be performed.
• Determine which studies are “elective” and reschedule them, performing all others. Identify “nonelective” (urgent/emergent) indications and defer all others.
• Determine the clinical benefit of echocardiography for symptomatic patients whose SARS-CoV-2 status is unknown.
• Cautiously consider the benefit of a TEE examination weighed against the risk for exposure of healthcare personnel to aerosolization in a patient with suspected or confirmed COVID-19.
• Postpone or cancel TEEs if an alternative imaging modality can provide the necessary information.
• Note that treadmill or bicycle stress echo tests in patients with COVID-19 may lead to exposure because of deep breathing and/or coughing during exercise. These tests should generally be deferred or converted to a pharmacologic stress echo.
   

   

The ASE statement also provides advice on safe imaging protocol and adequate personal protection measures.

“In addition to limiting the number of echocardiography practitioners involved in scanning, consideration should be given to limiting the exposure of staff who may be particularly susceptible to severe complications of COVID-19,” the ASE advises.

Staff who are older than 60 years, who have chronic conditions, are immunocompromised or are pregnant may wish to avoid contact with patients suspected or confirmed to have COVID-19.

It’s also important to realize the risk for transmission in reading rooms. “Keyboards, monitors, mice, chairs, phones, desktops, and door knobs should be frequently cleaned, and ventilation provided wherever possible,” the ASE advises. When the echo lab reading room is located in a high-traffic area, remote review of images or via webinar might be advisable, they suggest.

Summing up, Kirkland and colleagues say providing echocardiographic service “remains crucial in this difficult time of the SARS-CoV-2 outbreak. Working together, we can continue to provide high-quality care while minimizing risk to ourselves, our patients, and the public at large. Carefully considering ‘Whom to Image’, ‘Where to Image’ and ‘How to Image’ has the potential to reduce the risks of transmission.”

The authors note that the statements and recommendations are primarily based on expert opinion rather than on scientifically verified data and are subject to change as the COVID-19 outbreak continues to evolve and new data emerges.
 

This article first appeared on Medscape.com.

The American Society of Echocardiography (ASE) has issued a statement on protecting patients and echocardiography service providers during the COVID-19 pandemic.

Given the risk for cardiovascular complications associated with COVID-19, echocardiographic services will likely be needed for patients with suspected or confirmed COVID-19, meaning echo providers will be exposed to SARS-CoV-2, write the statement authors, led by James N. Kirkpatrick, MD, director of the echocardiography laboratory at University of Washington Medical Center in Seattle.

The statement was published online April 6 in the Journal of the American College of Cardiology.

The authors say the statement is intended to help guide the practice of echocardiography in this “challenging time.” It was developed with input from a variety of echocardiography providers and institutions who have experience with the COVID-19, or have been “actively and thoughtfully preparing for it.”

Who, When, Where, and How

The statement covers triaging and decision pathways for handling requests for echocardiography, as well as indications and recommended procedures, in cases of suspected or confirmed COVID-19.

Among the recommendations:

• Only perform transthoracic echocardiograms (TTE), stress echocardiograms, and transesophageal echocardiograms (TEE) if they are expected to provide clinical benefit. Appropriate-use criteria represent the first decision point as to whether an echocardiographic test should be performed.
• Determine which studies are “elective” and reschedule them, performing all others. Identify “nonelective” (urgent/emergent) indications and defer all others.
• Determine the clinical benefit of echocardiography for symptomatic patients whose SARS-CoV-2 status is unknown.
• Cautiously consider the benefit of a TEE examination weighed against the risk for exposure of healthcare personnel to aerosolization in a patient with suspected or confirmed COVID-19.
• Postpone or cancel TEEs if an alternative imaging modality can provide the necessary information.
• Note that treadmill or bicycle stress echo tests in patients with COVID-19 may lead to exposure because of deep breathing and/or coughing during exercise. These tests should generally be deferred or converted to a pharmacologic stress echo.
   

   

The ASE statement also provides advice on safe imaging protocol and adequate personal protection measures.

“In addition to limiting the number of echocardiography practitioners involved in scanning, consideration should be given to limiting the exposure of staff who may be particularly susceptible to severe complications of COVID-19,” the ASE advises.

Staff who are older than 60 years, who have chronic conditions, are immunocompromised or are pregnant may wish to avoid contact with patients suspected or confirmed to have COVID-19.

It’s also important to realize the risk for transmission in reading rooms. “Keyboards, monitors, mice, chairs, phones, desktops, and door knobs should be frequently cleaned, and ventilation provided wherever possible,” the ASE advises. When the echo lab reading room is located in a high-traffic area, remote review of images or via webinar might be advisable, they suggest.

Summing up, Kirkland and colleagues say providing echocardiographic service “remains crucial in this difficult time of the SARS-CoV-2 outbreak. Working together, we can continue to provide high-quality care while minimizing risk to ourselves, our patients, and the public at large. Carefully considering ‘Whom to Image’, ‘Where to Image’ and ‘How to Image’ has the potential to reduce the risks of transmission.”

The authors note that the statements and recommendations are primarily based on expert opinion rather than on scientifically verified data and are subject to change as the COVID-19 outbreak continues to evolve and new data emerges.
 

This article first appeared on Medscape.com.

The American Heart Association (AHA) and seven other medical societies have issued interim guidance to inform treatment of victims of cardiac arrest with suspected or confirmed COVID-19, focusing on reducing provider exposure, and prioritizing oxygenation and ventilation strategies, goals of care, and appropriateness of resuscitation.

“We were very specific in calling this ‘interim guidance’ based on expert opinion because things are evolving so quickly and we are learning more and more every day as more and more patients with COVID-19 are taken care of,” corresponding author Comilla Sasson, MD, PhD, vice president, Emergency Cardiovascular Care (ECC) Science and Innovation, American Heart Association, told theheart.org | Medscape Cardiology.

“We wanted this to be a starting point for providing the clinical guidance that everyone is looking for and, as we collect more data, the guidance will change, as it has for CDC [Centers for Disease Control and Prevention] and WHO [World Health Organization],” she said.

“The guidance sought to balance the provision of timely, high-quality resuscitation to patients while simultaneously protecting rescuers,” she added.

The guidance was published online April 9 in Circulation. The AHA produced the guidelines in collaboration with the American Academy of Pediatrics, American Association for Respiratory Care, American College of Emergency Physicians, the Society of Critical Care Anesthesiologists, and the American Society of Anesthesiologists, with support from the American Association of Critical Care Nurses and National EMS Physicians.
 

Respiratory Etiologies

“We think of cardiac arrest in adults, especially as related to cardiac etiologies, but we are now thinking of it in COVID-19 more as hypoxemia or respiratory failure, which can predispose patients to cardiac arrest,” Sasson explained.

Healthcare workers are the “highest-risk profession” for contracting the COVID-19, with resuscitations carrying “added risk” for several reasons, the authors note.

Administering CPR involves performing numerous aerosol-generating procedures that can cause viral particles to remain suspended in the air and be inhaled by those nearby, with a half-life of approximately 1 hour, they point out.

Moreover, resuscitation efforts “require numerous providers to work in close proximity to one another and the patient,” and the high-stress emergent nature of these events may result in lapses in infection-control procedures.

The guidance is designed “to protect not only the patient but also the provider and involves strategies regarding oxygenation and ventilation that differ from what we’ve done in the past since we have a strong feeling that this is a different disease process that may require different approaches than what we’ve dealt with in the past,” Sasson commented.

Reducing Provider Exposure

Providers should don PPE to protect both themselves and their colleagues from unnecessary exposure, the authors advise, noting that recommendations for PPE standards may “vary considerably,” so health or emergency medical services (EMS) standards should be taken into account.

Moreover, it is important to allow only the most essential providers into the room or on the scene. In keeping with reducing the number of rescuers, the authors recommend replacing manual chest compressions with mechanical CPR devices for patients who meet height and weight criteria in settings with “protocols and expertise in place for their use.”

COVID-19 status should be communicated to any new providers prior to their arrival on the scene, the authors stress.
 

Oxygenation and Ventilation Strategies

“Reducing risk of aerosolization during the process of intubation is key,” Sasson emphasized.

For this reason, a high-efficiency particulate air HEPA filter (if available) should be attached to any manual or mechanical ventilation device, specifically in the path of exhaled gas, before any breaths are administered.

Moreover, it is important to intubate early with a cuffed tube and connect to a mechanical ventilator, if possible. The intubator should be engaged with the “highest chance of first-pass success,” and chest compression should be paused to intubate.

To further increase the chance of a successful first intubation, use of video laryngoscopy (if available) is helpful.

Additional guidance includes:

• Using a bag-mask device (or T-piece in neonates) with a HEPA filter and a tight seal prior to intubation
• Considering passive oxygenation with non-rebreathing face mask as an alternative to bag-mask device for short duration (in adults)
• Considering supraglottic airway if intubation is delayed
• Minimizing closed circuit disconnections.

Resuscitation Considerations

“One big take-home point of the guidance is to consider resuscitation appropriateness, starting with goals of care when the patient comes to us, and continuing or stopping resuscitation when needed, based on the discussion with the family as well as local protocol,” Sasson said.

A variety of factors need to be taken into account, including age, comorbidities, and illness severity to determine the appropriateness of resuscitation, and “the likelihood of success” must be balanced “against the risk to rescuers and patients from whom resources are being diverted,” the authors state.

An Array of Scenarios

“We divided bystander CPR into adults vs pediatrics and into those who are living with a person who is in cardiac arrest – because they have already been exposed [to COVID-19] – vs those who are not living with the patient,” Sasson reported. “We also addressed the role of lay bystanders.”

For lay rescuers:

• Household members should perform at least hands-only CPR, if willing and able to do so
• Use of a face mark or cloth covering of the mouth and nose of the rescuer and/or patient may reduce the risk of transmission to a nonhousehold member
• In children, lay rescuers should perform chest compressions and “consider mouth-to-mouth resuscitation,” especially if they are household members.
• If available, an automated external defibrillator should be used to assess and treat victims of out-of-hospital cardiac arrest (OHCA).

The authors offer additional guidance for in-hospital cardiac arrest (IHCA), including addressing advanced care directives, closing the door when possible to prevent airborne contamination of adjacent space, and considering leaving the patient on a mechanical ventilator with HEPA filter.

They additionally address the special needs of neonates, recommending the presence of a “skilled attendant prepared to resuscitate, irrespective of COVID-19 status,” and stressing the importance of PPE since the mother may be a “potential source of aerosolization for the neonatal team.” Additional measures include avoidance of routine airway suctioning and the use of endotracheal medications.

Critically ill pregnant women with COVID-19 are more vulnerable to acute decompensation because of the cardiopulmonary physiological changes associated with pregnancy, the authors note. Preparation for a potential perimortem delivery should take place after 4 minutes of resuscitation and be initiated early in the resuscitation algorithm so as to allow specialized obstetrical and neonatal teams with PPE to convene.

“We will be continually updating this guidance and we are encouraging people to ask questions,” Sasson summarized.

She noted that a hospital-based COVID-19 registry is being formed to collect “clinically relevant data” that will inform and update the current guidance.

Sasson reports no relevant financial relationships. The other authors’ disclosures are listed on the original paper.
 

This article first appeared on Medscape.com.

The American Heart Association (AHA) and seven other medical societies have issued interim guidance to inform treatment of victims of cardiac arrest with suspected or confirmed COVID-19, focusing on reducing provider exposure, and prioritizing oxygenation and ventilation strategies, goals of care, and appropriateness of resuscitation.

“We were very specific in calling this ‘interim guidance’ based on expert opinion because things are evolving so quickly and we are learning more and more every day as more and more patients with COVID-19 are taken care of,” corresponding author Comilla Sasson, MD, PhD, vice president, Emergency Cardiovascular Care (ECC) Science and Innovation, American Heart Association, told theheart.org | Medscape Cardiology.

“We wanted this to be a starting point for providing the clinical guidance that everyone is looking for and, as we collect more data, the guidance will change, as it has for CDC [Centers for Disease Control and Prevention] and WHO [World Health Organization],” she said.

“The guidance sought to balance the provision of timely, high-quality resuscitation to patients while simultaneously protecting rescuers,” she added.

The guidance was published online April 9 in Circulation. The AHA produced the guidelines in collaboration with the American Academy of Pediatrics, American Association for Respiratory Care, American College of Emergency Physicians, the Society of Critical Care Anesthesiologists, and the American Society of Anesthesiologists, with support from the American Association of Critical Care Nurses and National EMS Physicians.
 

Respiratory Etiologies

“We think of cardiac arrest in adults, especially as related to cardiac etiologies, but we are now thinking of it in COVID-19 more as hypoxemia or respiratory failure, which can predispose patients to cardiac arrest,” Sasson explained.

Healthcare workers are the “highest-risk profession” for contracting the COVID-19, with resuscitations carrying “added risk” for several reasons, the authors note.

Administering CPR involves performing numerous aerosol-generating procedures that can cause viral particles to remain suspended in the air and be inhaled by those nearby, with a half-life of approximately 1 hour, they point out.

Moreover, resuscitation efforts “require numerous providers to work in close proximity to one another and the patient,” and the high-stress emergent nature of these events may result in lapses in infection-control procedures.

The guidance is designed “to protect not only the patient but also the provider and involves strategies regarding oxygenation and ventilation that differ from what we’ve done in the past since we have a strong feeling that this is a different disease process that may require different approaches than what we’ve dealt with in the past,” Sasson commented.

Reducing Provider Exposure

Providers should don PPE to protect both themselves and their colleagues from unnecessary exposure, the authors advise, noting that recommendations for PPE standards may “vary considerably,” so health or emergency medical services (EMS) standards should be taken into account.

Moreover, it is important to allow only the most essential providers into the room or on the scene. In keeping with reducing the number of rescuers, the authors recommend replacing manual chest compressions with mechanical CPR devices for patients who meet height and weight criteria in settings with “protocols and expertise in place for their use.”

COVID-19 status should be communicated to any new providers prior to their arrival on the scene, the authors stress.
 

Oxygenation and Ventilation Strategies

“Reducing risk of aerosolization during the process of intubation is key,” Sasson emphasized.

For this reason, a high-efficiency particulate air HEPA filter (if available) should be attached to any manual or mechanical ventilation device, specifically in the path of exhaled gas, before any breaths are administered.

Moreover, it is important to intubate early with a cuffed tube and connect to a mechanical ventilator, if possible. The intubator should be engaged with the “highest chance of first-pass success,” and chest compression should be paused to intubate.

To further increase the chance of a successful first intubation, use of video laryngoscopy (if available) is helpful.

Additional guidance includes:

• Using a bag-mask device (or T-piece in neonates) with a HEPA filter and a tight seal prior to intubation
• Considering passive oxygenation with non-rebreathing face mask as an alternative to bag-mask device for short duration (in adults)
• Considering supraglottic airway if intubation is delayed
• Minimizing closed circuit disconnections.

Resuscitation Considerations

“One big take-home point of the guidance is to consider resuscitation appropriateness, starting with goals of care when the patient comes to us, and continuing or stopping resuscitation when needed, based on the discussion with the family as well as local protocol,” Sasson said.

A variety of factors need to be taken into account, including age, comorbidities, and illness severity to determine the appropriateness of resuscitation, and “the likelihood of success” must be balanced “against the risk to rescuers and patients from whom resources are being diverted,” the authors state.

An Array of Scenarios

“We divided bystander CPR into adults vs pediatrics and into those who are living with a person who is in cardiac arrest – because they have already been exposed [to COVID-19] – vs those who are not living with the patient,” Sasson reported. “We also addressed the role of lay bystanders.”

For lay rescuers:

• Household members should perform at least hands-only CPR, if willing and able to do so
• Use of a face mark or cloth covering of the mouth and nose of the rescuer and/or patient may reduce the risk of transmission to a nonhousehold member
• In children, lay rescuers should perform chest compressions and “consider mouth-to-mouth resuscitation,” especially if they are household members.
• If available, an automated external defibrillator should be used to assess and treat victims of out-of-hospital cardiac arrest (OHCA).

The authors offer additional guidance for in-hospital cardiac arrest (IHCA), including addressing advanced care directives, closing the door when possible to prevent airborne contamination of adjacent space, and considering leaving the patient on a mechanical ventilator with HEPA filter.

They additionally address the special needs of neonates, recommending the presence of a “skilled attendant prepared to resuscitate, irrespective of COVID-19 status,” and stressing the importance of PPE since the mother may be a “potential source of aerosolization for the neonatal team.” Additional measures include avoidance of routine airway suctioning and the use of endotracheal medications.

Critically ill pregnant women with COVID-19 are more vulnerable to acute decompensation because of the cardiopulmonary physiological changes associated with pregnancy, the authors note. Preparation for a potential perimortem delivery should take place after 4 minutes of resuscitation and be initiated early in the resuscitation algorithm so as to allow specialized obstetrical and neonatal teams with PPE to convene.

“We will be continually updating this guidance and we are encouraging people to ask questions,” Sasson summarized.

She noted that a hospital-based COVID-19 registry is being formed to collect “clinically relevant data” that will inform and update the current guidance.

Sasson reports no relevant financial relationships. The other authors’ disclosures are listed on the original paper.
 

This article first appeared on Medscape.com.

The American Heart Association (AHA) and seven other medical societies have issued interim guidance to inform treatment of victims of cardiac arrest with suspected or confirmed COVID-19, focusing on reducing provider exposure, and prioritizing oxygenation and ventilation strategies, goals of care, and appropriateness of resuscitation.

“We were very specific in calling this ‘interim guidance’ based on expert opinion because things are evolving so quickly and we are learning more and more every day as more and more patients with COVID-19 are taken care of,” corresponding author Comilla Sasson, MD, PhD, vice president, Emergency Cardiovascular Care (ECC) Science and Innovation, American Heart Association, told theheart.org | Medscape Cardiology.

“We wanted this to be a starting point for providing the clinical guidance that everyone is looking for and, as we collect more data, the guidance will change, as it has for CDC [Centers for Disease Control and Prevention] and WHO [World Health Organization],” she said.

“The guidance sought to balance the provision of timely, high-quality resuscitation to patients while simultaneously protecting rescuers,” she added.

The guidance was published online April 9 in Circulation. The AHA produced the guidelines in collaboration with the American Academy of Pediatrics, American Association for Respiratory Care, American College of Emergency Physicians, the Society of Critical Care Anesthesiologists, and the American Society of Anesthesiologists, with support from the American Association of Critical Care Nurses and National EMS Physicians.
 

Respiratory Etiologies

“We think of cardiac arrest in adults, especially as related to cardiac etiologies, but we are now thinking of it in COVID-19 more as hypoxemia or respiratory failure, which can predispose patients to cardiac arrest,” Sasson explained.

Healthcare workers are the “highest-risk profession” for contracting the COVID-19, with resuscitations carrying “added risk” for several reasons, the authors note.

Administering CPR involves performing numerous aerosol-generating procedures that can cause viral particles to remain suspended in the air and be inhaled by those nearby, with a half-life of approximately 1 hour, they point out.

Moreover, resuscitation efforts “require numerous providers to work in close proximity to one another and the patient,” and the high-stress emergent nature of these events may result in lapses in infection-control procedures.

The guidance is designed “to protect not only the patient but also the provider and involves strategies regarding oxygenation and ventilation that differ from what we’ve done in the past since we have a strong feeling that this is a different disease process that may require different approaches than what we’ve dealt with in the past,” Sasson commented.

Reducing Provider Exposure

Providers should don PPE to protect both themselves and their colleagues from unnecessary exposure, the authors advise, noting that recommendations for PPE standards may “vary considerably,” so health or emergency medical services (EMS) standards should be taken into account.

Moreover, it is important to allow only the most essential providers into the room or on the scene. In keeping with reducing the number of rescuers, the authors recommend replacing manual chest compressions with mechanical CPR devices for patients who meet height and weight criteria in settings with “protocols and expertise in place for their use.”

COVID-19 status should be communicated to any new providers prior to their arrival on the scene, the authors stress.
 

Oxygenation and Ventilation Strategies

“Reducing risk of aerosolization during the process of intubation is key,” Sasson emphasized.

For this reason, a high-efficiency particulate air HEPA filter (if available) should be attached to any manual or mechanical ventilation device, specifically in the path of exhaled gas, before any breaths are administered.

Moreover, it is important to intubate early with a cuffed tube and connect to a mechanical ventilator, if possible. The intubator should be engaged with the “highest chance of first-pass success,” and chest compression should be paused to intubate.

To further increase the chance of a successful first intubation, use of video laryngoscopy (if available) is helpful.

Additional guidance includes:

• Using a bag-mask device (or T-piece in neonates) with a HEPA filter and a tight seal prior to intubation
• Considering passive oxygenation with non-rebreathing face mask as an alternative to bag-mask device for short duration (in adults)
• Considering supraglottic airway if intubation is delayed
• Minimizing closed circuit disconnections.

Resuscitation Considerations

“One big take-home point of the guidance is to consider resuscitation appropriateness, starting with goals of care when the patient comes to us, and continuing or stopping resuscitation when needed, based on the discussion with the family as well as local protocol,” Sasson said.

A variety of factors need to be taken into account, including age, comorbidities, and illness severity to determine the appropriateness of resuscitation, and “the likelihood of success” must be balanced “against the risk to rescuers and patients from whom resources are being diverted,” the authors state.

An Array of Scenarios

“We divided bystander CPR into adults vs pediatrics and into those who are living with a person who is in cardiac arrest – because they have already been exposed [to COVID-19] – vs those who are not living with the patient,” Sasson reported. “We also addressed the role of lay bystanders.”

For lay rescuers:

• Household members should perform at least hands-only CPR, if willing and able to do so
• Use of a face mark or cloth covering of the mouth and nose of the rescuer and/or patient may reduce the risk of transmission to a nonhousehold member
• In children, lay rescuers should perform chest compressions and “consider mouth-to-mouth resuscitation,” especially if they are household members.
• If available, an automated external defibrillator should be used to assess and treat victims of out-of-hospital cardiac arrest (OHCA).

The authors offer additional guidance for in-hospital cardiac arrest (IHCA), including addressing advanced care directives, closing the door when possible to prevent airborne contamination of adjacent space, and considering leaving the patient on a mechanical ventilator with HEPA filter.

They additionally address the special needs of neonates, recommending the presence of a “skilled attendant prepared to resuscitate, irrespective of COVID-19 status,” and stressing the importance of PPE since the mother may be a “potential source of aerosolization for the neonatal team.” Additional measures include avoidance of routine airway suctioning and the use of endotracheal medications.

Critically ill pregnant women with COVID-19 are more vulnerable to acute decompensation because of the cardiopulmonary physiological changes associated with pregnancy, the authors note. Preparation for a potential perimortem delivery should take place after 4 minutes of resuscitation and be initiated early in the resuscitation algorithm so as to allow specialized obstetrical and neonatal teams with PPE to convene.

“We will be continually updating this guidance and we are encouraging people to ask questions,” Sasson summarized.

She noted that a hospital-based COVID-19 registry is being formed to collect “clinically relevant data” that will inform and update the current guidance.

Sasson reports no relevant financial relationships. The other authors’ disclosures are listed on the original paper.
 

This article first appeared on Medscape.com.

There was no hand sanitizer on the hospital’s psychiatric ward for fear patients would drink it; they slept together on futons in communal rooms and the windows were sealed shut to prevent suicide attempts — all conditions that created the perfect environment for the rapid spread of a potentially deadly virus.

This scenario may sound like a something out of a horror film, but as reported last month by the UK newspaper The Independent, it was the reality in the psychiatric ward of South Korea’s Daenam Hospital after COVID-19 struck. Eventually health officials put the ward on lockdown, but it wasn’t long before all but two of the unit’s 103 patients were positive for the virus.

To avoid a similar catastrophe, staff at an Israeli hospital have created what they describe as the “world’s first” dedicated COVID-19 unit for psychiatric inpatients.

Clinicians at Israel’s national hospital, Sheba Medical Center Tel HaShomer in Tel Aviv, believe the 16-bed unit, which officially opened on March 26, will stop psychiatric inpatients with the virus — who may have trouble with social distancing — from spreading it to others on the ward.

“Psychiatric patients are going to get sick from coronavirus just like anybody else,” Mark Weiser, MD, head of the psychiatric division at the institution told Medscape Medical News. “But we’re concerned that, on a psychiatric ward, a patient who is COVID-19 positive can also be psychotic, manic, cognitively impaired, or have poor judgment … making it difficult for that patient to keep social distancing, and very quickly you’ll have an entire ward of patients infected.

“So the basic public health issue is how to prevent a single psychiatric patient who is hospitalized and COVID-19-positive from making everybody else sick,” he added.
 

Unique Challenges, Rapid Response

Adapting an existing psychiatric ward to one exclusively used by inpatients with COVID-19 required significant planning, coordination, and modifications to ensure the well-being of patients and staff.

First, the ward’s air conditioning system was re-engineered to separate it from the hospital’s main system. A dedicated entrance for the exclusive use of infected psychiatric inpatients was also created.

In addition, two-way television cameras in patients’ rooms were installed to facilitate a constant flow of communication and enable therapeutic sessions and family visits. All of these modifications were completed in under a week.

“Under normal circumstances, we have cameras in the public areas of our wards, but in order to respect people’s privacy, we do not have cameras in their rooms.

“In this specific ward, on the other hand, we did put cameras in the rooms, so if a patient needs to be watched more closely, it could be done remotely without exposing staff to the virus. We have a person who’s watching the screens at all times, just to see what’s going on and see what patients are doing,” said Weiser.

Protective personal equipment (PPE) and clothing for staff was tailored to the unique challenges posed by the ward’s patient population.

“Of course, you need to wear clothes that are protective against the virus,” said Weiser. “But sometimes our patients can get agitated or even violent, so you’ve got protect against that as well.”

With this in mind, all personnel working on the ward must put on an extra layer of PPE as well as a tear-proof robe. The institution has also implemented a strict protocol that dictates the order in which PPE is donned and doffed.

“It’s got to be done in a very careful and very specific way,” said Weiser. “We have all of it organized with a poster that explains what should be taken off or put on, and in what order.”

For institutions considering setting up a similar unit, Weiser said close proximity to an active care hospital with the capacity to provide urgent care is key.

“We’re psychiatrists; we’re not great at treating acute respiratory problems. So patients with significant respiratory problems need a place to get appropriate care quickly,” he said.

In setting up the unit, there were still a few obstacles, Weiser noted. For instance, despite the many protective and safety measures undertaken by the institution, some of the hospital staff were concerned about their risk of contracting the virus.

To address these concerns, the hospital’s leadership brought in infectious disease experts to educate hospital personnel about the virus and transmission risk.

“They told our staff that given all the precautions we had taken, there was very little risk anyone else could become infected,” Weiser said.

Despite the many challenges, Weiser said he and his colleagues are thrilled with the dedicated ward and the positive reception it has received.

“My colleagues and the directors of psychiatric hospitals all around the country are very happy with this because now they’re not hospitalizing infected patients. They’re very happy for us to take care of this,” he said.
 

“No Easy Solutions”

Commenting on the initiative for Medscape Medical News, John M. Oldham, MD, chief of staff at Baylor College of Medicine’s Menninger Clinic in Houston, Texas, raised some questions.

“Is it really going to be the treatment unit or a quarantine unit? Because if you don’t have a comparable level of established, effective treatment for these patients, then you’re simply herding them off to a different place where they’re going to suffer both illnesses,” he cautioned.

Nevertheless, Oldham recognized that the issue of how to treat psychiatric patients who test positive for COVID-19 is complex.

“We’re still wrestling with that question here at Menninger. We have created an enclosed section of the inpatient area reserved for this possibility.

“If we have a patient who tests positive, we will immediately put that patient in one of these rooms in the quarantine section. Then we will use protective equipment for our staff to go and provide care for the patient,” he said.

However, he acknowledged that a psychiatric hospital is in no position to treat patients who develop severe illness from COVID-19.

“We’re certainly worried about it,” he said, “because how many inpatient general medical units are going to want to take a significantly symptomatic COVID-19 patient who was in the hospital for being acutely suicidal? There are no easy solutions.”
 

This article first appeared on Medscape.com.

There was no hand sanitizer on the hospital’s psychiatric ward for fear patients would drink it; they slept together on futons in communal rooms and the windows were sealed shut to prevent suicide attempts — all conditions that created the perfect environment for the rapid spread of a potentially deadly virus.

This scenario may sound like a something out of a horror film, but as reported last month by the UK newspaper The Independent, it was the reality in the psychiatric ward of South Korea’s Daenam Hospital after COVID-19 struck. Eventually health officials put the ward on lockdown, but it wasn’t long before all but two of the unit’s 103 patients were positive for the virus.

To avoid a similar catastrophe, staff at an Israeli hospital have created what they describe as the “world’s first” dedicated COVID-19 unit for psychiatric inpatients.

Clinicians at Israel’s national hospital, Sheba Medical Center Tel HaShomer in Tel Aviv, believe the 16-bed unit, which officially opened on March 26, will stop psychiatric inpatients with the virus — who may have trouble with social distancing — from spreading it to others on the ward.

“Psychiatric patients are going to get sick from coronavirus just like anybody else,” Mark Weiser, MD, head of the psychiatric division at the institution told Medscape Medical News. “But we’re concerned that, on a psychiatric ward, a patient who is COVID-19 positive can also be psychotic, manic, cognitively impaired, or have poor judgment … making it difficult for that patient to keep social distancing, and very quickly you’ll have an entire ward of patients infected.

“So the basic public health issue is how to prevent a single psychiatric patient who is hospitalized and COVID-19-positive from making everybody else sick,” he added.
 

Unique Challenges, Rapid Response

Adapting an existing psychiatric ward to one exclusively used by inpatients with COVID-19 required significant planning, coordination, and modifications to ensure the well-being of patients and staff.

First, the ward’s air conditioning system was re-engineered to separate it from the hospital’s main system. A dedicated entrance for the exclusive use of infected psychiatric inpatients was also created.

In addition, two-way television cameras in patients’ rooms were installed to facilitate a constant flow of communication and enable therapeutic sessions and family visits. All of these modifications were completed in under a week.

“Under normal circumstances, we have cameras in the public areas of our wards, but in order to respect people’s privacy, we do not have cameras in their rooms.

“In this specific ward, on the other hand, we did put cameras in the rooms, so if a patient needs to be watched more closely, it could be done remotely without exposing staff to the virus. We have a person who’s watching the screens at all times, just to see what’s going on and see what patients are doing,” said Weiser.

Protective personal equipment (PPE) and clothing for staff was tailored to the unique challenges posed by the ward’s patient population.

“Of course, you need to wear clothes that are protective against the virus,” said Weiser. “But sometimes our patients can get agitated or even violent, so you’ve got protect against that as well.”

With this in mind, all personnel working on the ward must put on an extra layer of PPE as well as a tear-proof robe. The institution has also implemented a strict protocol that dictates the order in which PPE is donned and doffed.

“It’s got to be done in a very careful and very specific way,” said Weiser. “We have all of it organized with a poster that explains what should be taken off or put on, and in what order.”

For institutions considering setting up a similar unit, Weiser said close proximity to an active care hospital with the capacity to provide urgent care is key.

“We’re psychiatrists; we’re not great at treating acute respiratory problems. So patients with significant respiratory problems need a place to get appropriate care quickly,” he said.

In setting up the unit, there were still a few obstacles, Weiser noted. For instance, despite the many protective and safety measures undertaken by the institution, some of the hospital staff were concerned about their risk of contracting the virus.

To address these concerns, the hospital’s leadership brought in infectious disease experts to educate hospital personnel about the virus and transmission risk.

“They told our staff that given all the precautions we had taken, there was very little risk anyone else could become infected,” Weiser said.

Despite the many challenges, Weiser said he and his colleagues are thrilled with the dedicated ward and the positive reception it has received.

“My colleagues and the directors of psychiatric hospitals all around the country are very happy with this because now they’re not hospitalizing infected patients. They’re very happy for us to take care of this,” he said.
 

“No Easy Solutions”

Commenting on the initiative for Medscape Medical News, John M. Oldham, MD, chief of staff at Baylor College of Medicine’s Menninger Clinic in Houston, Texas, raised some questions.

“Is it really going to be the treatment unit or a quarantine unit? Because if you don’t have a comparable level of established, effective treatment for these patients, then you’re simply herding them off to a different place where they’re going to suffer both illnesses,” he cautioned.

Nevertheless, Oldham recognized that the issue of how to treat psychiatric patients who test positive for COVID-19 is complex.

“We’re still wrestling with that question here at Menninger. We have created an enclosed section of the inpatient area reserved for this possibility.

“If we have a patient who tests positive, we will immediately put that patient in one of these rooms in the quarantine section. Then we will use protective equipment for our staff to go and provide care for the patient,” he said.

However, he acknowledged that a psychiatric hospital is in no position to treat patients who develop severe illness from COVID-19.

“We’re certainly worried about it,” he said, “because how many inpatient general medical units are going to want to take a significantly symptomatic COVID-19 patient who was in the hospital for being acutely suicidal? There are no easy solutions.”
 

This article first appeared on Medscape.com.

There was no hand sanitizer on the hospital’s psychiatric ward for fear patients would drink it; they slept together on futons in communal rooms and the windows were sealed shut to prevent suicide attempts — all conditions that created the perfect environment for the rapid spread of a potentially deadly virus.

This scenario may sound like a something out of a horror film, but as reported last month by the UK newspaper The Independent, it was the reality in the psychiatric ward of South Korea’s Daenam Hospital after COVID-19 struck. Eventually health officials put the ward on lockdown, but it wasn’t long before all but two of the unit’s 103 patients were positive for the virus.

To avoid a similar catastrophe, staff at an Israeli hospital have created what they describe as the “world’s first” dedicated COVID-19 unit for psychiatric inpatients.

Clinicians at Israel’s national hospital, Sheba Medical Center Tel HaShomer in Tel Aviv, believe the 16-bed unit, which officially opened on March 26, will stop psychiatric inpatients with the virus — who may have trouble with social distancing — from spreading it to others on the ward.

“Psychiatric patients are going to get sick from coronavirus just like anybody else,” Mark Weiser, MD, head of the psychiatric division at the institution told Medscape Medical News. “But we’re concerned that, on a psychiatric ward, a patient who is COVID-19 positive can also be psychotic, manic, cognitively impaired, or have poor judgment … making it difficult for that patient to keep social distancing, and very quickly you’ll have an entire ward of patients infected.

“So the basic public health issue is how to prevent a single psychiatric patient who is hospitalized and COVID-19-positive from making everybody else sick,” he added.
 

Unique Challenges, Rapid Response

Adapting an existing psychiatric ward to one exclusively used by inpatients with COVID-19 required significant planning, coordination, and modifications to ensure the well-being of patients and staff.

First, the ward’s air conditioning system was re-engineered to separate it from the hospital’s main system. A dedicated entrance for the exclusive use of infected psychiatric inpatients was also created.

In addition, two-way television cameras in patients’ rooms were installed to facilitate a constant flow of communication and enable therapeutic sessions and family visits. All of these modifications were completed in under a week.

“Under normal circumstances, we have cameras in the public areas of our wards, but in order to respect people’s privacy, we do not have cameras in their rooms.

“In this specific ward, on the other hand, we did put cameras in the rooms, so if a patient needs to be watched more closely, it could be done remotely without exposing staff to the virus. We have a person who’s watching the screens at all times, just to see what’s going on and see what patients are doing,” said Weiser.

Protective personal equipment (PPE) and clothing for staff was tailored to the unique challenges posed by the ward’s patient population.

“Of course, you need to wear clothes that are protective against the virus,” said Weiser. “But sometimes our patients can get agitated or even violent, so you’ve got protect against that as well.”

With this in mind, all personnel working on the ward must put on an extra layer of PPE as well as a tear-proof robe. The institution has also implemented a strict protocol that dictates the order in which PPE is donned and doffed.

“It’s got to be done in a very careful and very specific way,” said Weiser. “We have all of it organized with a poster that explains what should be taken off or put on, and in what order.”

For institutions considering setting up a similar unit, Weiser said close proximity to an active care hospital with the capacity to provide urgent care is key.

“We’re psychiatrists; we’re not great at treating acute respiratory problems. So patients with significant respiratory problems need a place to get appropriate care quickly,” he said.

In setting up the unit, there were still a few obstacles, Weiser noted. For instance, despite the many protective and safety measures undertaken by the institution, some of the hospital staff were concerned about their risk of contracting the virus.

To address these concerns, the hospital’s leadership brought in infectious disease experts to educate hospital personnel about the virus and transmission risk.

“They told our staff that given all the precautions we had taken, there was very little risk anyone else could become infected,” Weiser said.

Despite the many challenges, Weiser said he and his colleagues are thrilled with the dedicated ward and the positive reception it has received.

“My colleagues and the directors of psychiatric hospitals all around the country are very happy with this because now they’re not hospitalizing infected patients. They’re very happy for us to take care of this,” he said.
 

“No Easy Solutions”

Commenting on the initiative for Medscape Medical News, John M. Oldham, MD, chief of staff at Baylor College of Medicine’s Menninger Clinic in Houston, Texas, raised some questions.

“Is it really going to be the treatment unit or a quarantine unit? Because if you don’t have a comparable level of established, effective treatment for these patients, then you’re simply herding them off to a different place where they’re going to suffer both illnesses,” he cautioned.

Nevertheless, Oldham recognized that the issue of how to treat psychiatric patients who test positive for COVID-19 is complex.

“We’re still wrestling with that question here at Menninger. We have created an enclosed section of the inpatient area reserved for this possibility.

“If we have a patient who tests positive, we will immediately put that patient in one of these rooms in the quarantine section. Then we will use protective equipment for our staff to go and provide care for the patient,” he said.

However, he acknowledged that a psychiatric hospital is in no position to treat patients who develop severe illness from COVID-19.

“We’re certainly worried about it,” he said, “because how many inpatient general medical units are going to want to take a significantly symptomatic COVID-19 patient who was in the hospital for being acutely suicidal? There are no easy solutions.”
 

This article first appeared on Medscape.com.

Because of their place at the interface between critical care and cardiovascular medicine, critical care cardiologists are in a good position to come up with novel approaches to adapting critical care systems to the current crisis. Health care and clinical resources have been severely strained in some places, and increasing evidence suggests that SARS-CoV-2 can cause injury to most organ systems. More than a quarter of hospitalized patients have cardiac injury, which can be a key reason for clinical deterioration.

An international group of critical care cardiologists led by Jason Katz, MD, of Duke University, Durham, N.C., offered suggestions for scalable models for critical care delivery in the context of COVID-19 in the Journal of the American College of Cardiology.

Critical care cardiology developed in response to changes in patient populations and their clinical needs. Respiratory insufficiency, heart failure, structural heart disease, and multisystem organ dysfunction became more common than patients with complicated acute MI, leading cardiologists in critical care cardiology to become more proficient in general critical care medicine, and to become leaders in forming collaborative multidisciplinary teams. The authors argued that COVID-19 is precipitating a similar need to adapt to the changing needs of patients.

“This pandemic should serve as a clarion call to our health care systems that we should continue to develop a nimble workforce that can adapt to change quickly during a crisis. We believe critical care cardiologists are well positioned to help serve society in this capacity,” the authors wrote.
 

Surge staging

They proposed four surge stages based in part on an American College of Chest Physicians–endorsed model (Chest 2014 Oct;146:e61S-74S), which regards a 25% capacity surge as minor. At the other end of the spectrum, a 200% surge is defined as a “disaster.” In minor surges (less than 25% increase), the traditional cardiac ICU (CICU) model can continue to be applied. During moderate (25%-100% increases) or major (100%-200%) surges, the critical care cardiologist should collaborate or consult within multiple health care teams. Physicians not trained in critical care can assist with care of intubated and critically ill patients under the supervision of a critical care cardiologist or under the supervision of a partnership between a non–cardiac critical care medicine provider and a cardiologist. The number of patients cared for by each team should increase in step with the size of the surge.

In disaster situations (more than 200% surge), there should be adaptive and dynamic staffing reorganization. The report included an illustration of a range of steps that can be taken, including alterations to staffing, regional care systems, resource management, and triage practices. Scoring systems such as Sequential Organ Failure Assessment may be useful for triaging, but the authors also suggest employment of validated cardiac disease–specific scores, because traditional ICU measures don’t always apply well to CICU populations.

At the hospital level, deferrals should be made for elective cardiac procedures that require CICU or postanesthesia care unit recovery periods. Semielective procedures should be considered after risk-benefit considerations when delays could lead to morbidity or mortality. Even some traditional emergency procedures may need to be reevaluated in the COVID-19 context: For example, some low-risk ST-segment elevation MI (STEMI) patients don’t require ICU care but are manageable in cardiac intermediate care beds instead. Historical triage practices should be reexamined to predict which STEMI patients will require ICU care.
 

Resource allocation

The CICU work flow will be affected as some of its beds are opened up to COVID-19 patients. Standard philosophies of concentrating intense resources will have to give way to a utilitarian approach that evaluates operations based on efficiency, equity, and justice. Physician-patient contact should be minimized using technological links when possible, and rounds might be reorganized to first examine patients without COVID-19, in order to minimize between-patient spread.

Military medicine, which is used to ramping up operations during times of crisis, has potential lessons for the current pandemic. In the face of mass casualties, military physicians often turn to the North Atlantic Treaty Organization triage system, which separates patients into four categories: immediate, requiring lifesaving intervention; delayed, requiring intervention within hours to days; minimal, where the patient is injured but ambulatory; and expectant patients who are deceased or too injured to save. Impersonal though this system may be, it may be required in the most severe scenarios when resources are scarce or absent.

The authors reported no relevant financial disclosures.

SOURCE: Katz J et al. J Am Coll Cardiol. 2020 Apr 15. doi: 10.1016/j.annonc.2020.02.01.

Because of their place at the interface between critical care and cardiovascular medicine, critical care cardiologists are in a good position to come up with novel approaches to adapting critical care systems to the current crisis. Health care and clinical resources have been severely strained in some places, and increasing evidence suggests that SARS-CoV-2 can cause injury to most organ systems. More than a quarter of hospitalized patients have cardiac injury, which can be a key reason for clinical deterioration.

An international group of critical care cardiologists led by Jason Katz, MD, of Duke University, Durham, N.C., offered suggestions for scalable models for critical care delivery in the context of COVID-19 in the Journal of the American College of Cardiology.

Critical care cardiology developed in response to changes in patient populations and their clinical needs. Respiratory insufficiency, heart failure, structural heart disease, and multisystem organ dysfunction became more common than patients with complicated acute MI, leading cardiologists in critical care cardiology to become more proficient in general critical care medicine, and to become leaders in forming collaborative multidisciplinary teams. The authors argued that COVID-19 is precipitating a similar need to adapt to the changing needs of patients.

“This pandemic should serve as a clarion call to our health care systems that we should continue to develop a nimble workforce that can adapt to change quickly during a crisis. We believe critical care cardiologists are well positioned to help serve society in this capacity,” the authors wrote.
 

Surge staging

They proposed four surge stages based in part on an American College of Chest Physicians–endorsed model (Chest 2014 Oct;146:e61S-74S), which regards a 25% capacity surge as minor. At the other end of the spectrum, a 200% surge is defined as a “disaster.” In minor surges (less than 25% increase), the traditional cardiac ICU (CICU) model can continue to be applied. During moderate (25%-100% increases) or major (100%-200%) surges, the critical care cardiologist should collaborate or consult within multiple health care teams. Physicians not trained in critical care can assist with care of intubated and critically ill patients under the supervision of a critical care cardiologist or under the supervision of a partnership between a non–cardiac critical care medicine provider and a cardiologist. The number of patients cared for by each team should increase in step with the size of the surge.

In disaster situations (more than 200% surge), there should be adaptive and dynamic staffing reorganization. The report included an illustration of a range of steps that can be taken, including alterations to staffing, regional care systems, resource management, and triage practices. Scoring systems such as Sequential Organ Failure Assessment may be useful for triaging, but the authors also suggest employment of validated cardiac disease–specific scores, because traditional ICU measures don’t always apply well to CICU populations.

At the hospital level, deferrals should be made for elective cardiac procedures that require CICU or postanesthesia care unit recovery periods. Semielective procedures should be considered after risk-benefit considerations when delays could lead to morbidity or mortality. Even some traditional emergency procedures may need to be reevaluated in the COVID-19 context: For example, some low-risk ST-segment elevation MI (STEMI) patients don’t require ICU care but are manageable in cardiac intermediate care beds instead. Historical triage practices should be reexamined to predict which STEMI patients will require ICU care.
 

Resource allocation

The CICU work flow will be affected as some of its beds are opened up to COVID-19 patients. Standard philosophies of concentrating intense resources will have to give way to a utilitarian approach that evaluates operations based on efficiency, equity, and justice. Physician-patient contact should be minimized using technological links when possible, and rounds might be reorganized to first examine patients without COVID-19, in order to minimize between-patient spread.

Military medicine, which is used to ramping up operations during times of crisis, has potential lessons for the current pandemic. In the face of mass casualties, military physicians often turn to the North Atlantic Treaty Organization triage system, which separates patients into four categories: immediate, requiring lifesaving intervention; delayed, requiring intervention within hours to days; minimal, where the patient is injured but ambulatory; and expectant patients who are deceased or too injured to save. Impersonal though this system may be, it may be required in the most severe scenarios when resources are scarce or absent.

The authors reported no relevant financial disclosures.

SOURCE: Katz J et al. J Am Coll Cardiol. 2020 Apr 15. doi: 10.1016/j.annonc.2020.02.01.

Because of their place at the interface between critical care and cardiovascular medicine, critical care cardiologists are in a good position to come up with novel approaches to adapting critical care systems to the current crisis. Health care and clinical resources have been severely strained in some places, and increasing evidence suggests that SARS-CoV-2 can cause injury to most organ systems. More than a quarter of hospitalized patients have cardiac injury, which can be a key reason for clinical deterioration.

An international group of critical care cardiologists led by Jason Katz, MD, of Duke University, Durham, N.C., offered suggestions for scalable models for critical care delivery in the context of COVID-19 in the Journal of the American College of Cardiology.

Critical care cardiology developed in response to changes in patient populations and their clinical needs. Respiratory insufficiency, heart failure, structural heart disease, and multisystem organ dysfunction became more common than patients with complicated acute MI, leading cardiologists in critical care cardiology to become more proficient in general critical care medicine, and to become leaders in forming collaborative multidisciplinary teams. The authors argued that COVID-19 is precipitating a similar need to adapt to the changing needs of patients.

“This pandemic should serve as a clarion call to our health care systems that we should continue to develop a nimble workforce that can adapt to change quickly during a crisis. We believe critical care cardiologists are well positioned to help serve society in this capacity,” the authors wrote.
 

Surge staging

They proposed four surge stages based in part on an American College of Chest Physicians–endorsed model (Chest 2014 Oct;146:e61S-74S), which regards a 25% capacity surge as minor. At the other end of the spectrum, a 200% surge is defined as a “disaster.” In minor surges (less than 25% increase), the traditional cardiac ICU (CICU) model can continue to be applied. During moderate (25%-100% increases) or major (100%-200%) surges, the critical care cardiologist should collaborate or consult within multiple health care teams. Physicians not trained in critical care can assist with care of intubated and critically ill patients under the supervision of a critical care cardiologist or under the supervision of a partnership between a non–cardiac critical care medicine provider and a cardiologist. The number of patients cared for by each team should increase in step with the size of the surge.

In disaster situations (more than 200% surge), there should be adaptive and dynamic staffing reorganization. The report included an illustration of a range of steps that can be taken, including alterations to staffing, regional care systems, resource management, and triage practices. Scoring systems such as Sequential Organ Failure Assessment may be useful for triaging, but the authors also suggest employment of validated cardiac disease–specific scores, because traditional ICU measures don’t always apply well to CICU populations.

At the hospital level, deferrals should be made for elective cardiac procedures that require CICU or postanesthesia care unit recovery periods. Semielective procedures should be considered after risk-benefit considerations when delays could lead to morbidity or mortality. Even some traditional emergency procedures may need to be reevaluated in the COVID-19 context: For example, some low-risk ST-segment elevation MI (STEMI) patients don’t require ICU care but are manageable in cardiac intermediate care beds instead. Historical triage practices should be reexamined to predict which STEMI patients will require ICU care.
 

Resource allocation

The CICU work flow will be affected as some of its beds are opened up to COVID-19 patients. Standard philosophies of concentrating intense resources will have to give way to a utilitarian approach that evaluates operations based on efficiency, equity, and justice. Physician-patient contact should be minimized using technological links when possible, and rounds might be reorganized to first examine patients without COVID-19, in order to minimize between-patient spread.

Military medicine, which is used to ramping up operations during times of crisis, has potential lessons for the current pandemic. In the face of mass casualties, military physicians often turn to the North Atlantic Treaty Organization triage system, which separates patients into four categories: immediate, requiring lifesaving intervention; delayed, requiring intervention within hours to days; minimal, where the patient is injured but ambulatory; and expectant patients who are deceased or too injured to save. Impersonal though this system may be, it may be required in the most severe scenarios when resources are scarce or absent.

The authors reported no relevant financial disclosures.

SOURCE: Katz J et al. J Am Coll Cardiol. 2020 Apr 15. doi: 10.1016/j.annonc.2020.02.01.

The explanation for the impressive clinical benefits of sacubitril/valsartan in women with heart failure with preserved ejection fraction in the PARAGON-HF trial – but not in the men – remains elusive, Jonathan W. Cunningham, MD, said at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

American College of Cardiology

“We’ve all been trying to unravel the explanation for the differential effects between men and women in the primary trial. I don’t know that this NT-proBNP substudy gives a clear answer because we did see similar reduction in NT-proBNP in the men and women,” said Dr. Cunningham of Brigham and Women’s Hospital, Boston.

“Unfortunately, I think we’re still looking for the underlying physiological explanation for that very interesting interaction,” he added.

The PARAGON-HF trial included 4,796 patients with heart failure with preserved ejection fraction (HFpEF) who were randomized double-blind to sacubitril/valsartan (Entresto) or valsartan on top of background guideline-directed medical therapy and followed for a median of 34 months (N Engl J Med. 2019 Oct 24;381[17]:1609-20). The sacubitril/valsartan group’s 13% relative risk reduction in the primary composite endpoint of cardiovascular death and total heart failure hospitalizations fell tantalizingly short of statistical significance (P = 0.058).

In women, however, who comprised more than half of the study population, the benefit of sacubitril/valsartan was larger: a 27% relative risk reduction compared to valsartan alone. That’s a statistically significant difference in a prespecified subgroup analysis, but according to the rules of clinical trials and statistics it must be considered hypothesis-generating and nondefinitive, since the overall trial was negative. Men randomized to sacubitril/valsartan had a modest 3% increased risk of the primary endpoint compared to men on valsartan.

Because of the enormous unmet need for effective therapy for HFpEF, and the fact that HFpEF is more common in women than men, the search is on for an explanation that would account for the striking gender difference in outcome in PARAGON-HF. At ACC 2020, Dr. Cunningham presented a secondary analysis of the trial focusing on the relationships between baseline and on-treatment N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and clinical outcomes.

Among the key findings was that the higher the baseline NT-proBNP, the greater the likelihood of the primary endpoint. Also, sacubitril/valsartan reduced NT-proBNP to a similar extent in men and women: For example, by 20% compared to valsartan in men and by 18% in women when measured 16 weeks after randomization. And reduction in NT-proBNP was associated with reduced risk of cardiovascular death and heart failure hospitalizations; indeed, 60% of participants in PARAGON-HF experienced a decrease in NT-proBNP, and they had a 23% lower event rate compared to patients whose NT-proBNP increased during the course of the study.

Another intriguing finding in the parent PARAGON-HF trial was that HFpEF patients with an LVEF of 45%-57% had a 22% lower rate of the primary endpoint than those with an LVEF of 58% or more. But as with the gender difference in clinical outcomes in response to sacubitril/valsartan, the difference in outcomes based on ejection fraction was not mediated by the drug’s impact on NT-proBNP, since sacubitril/valsartan reduced NT-proBNP to a similar degree in HFpEF patients with an LVEF above or below 57%.

The difference in outcomes by ejection fraction wasn’t entirely surprising, because those low-normal–range ejection fractions where sacubitril/valsartan had a favorable impact approach those characteristic of heart failure with reduced ejection fraction (HFrEF), and guidelines give sacubitril/valsartan a class I recommendation in patients with HFrEF on the strength of the medication’s demonstrated reduction in morbidity and mortality in the PARADIGM-HF trial.

Discussant Lee R. Goldberg, MD, predicted this analysis will have an impact on the design of future clinical trials in HFpEF, which up until now have required certain minimum NT-proBNP levels for participation.

“Maybe this is why so many of our trials in HFpEF have been unsuccessful. It’s a very heterogeneous population and perhaps NT-proBNP cutoffs are leading to a lot of mischief or heterogeneity that causes us some difficulty,” said Dr. Goldberg, professor of medicine and chief of the section of advanced heart failure and cardiac transplantation at the University of Pennsylvania, Philadelphia.

Dr. Cunningham reported having no financial conflicts regarding his study. The PARAGON-HF trial was funded by Novartis.

Simultaneously with Dr. Cunningham’s presentation at ACC 2020, the study results were published online (JACC Heart Fail. 2020 Mar 26; doi: 10.1016/j.jchf.2020.03.002.

[email protected]

SOURCE: Cunningham JW. ACC 2020, Abstract 412-08.

The explanation for the impressive clinical benefits of sacubitril/valsartan in women with heart failure with preserved ejection fraction in the PARAGON-HF trial – but not in the men – remains elusive, Jonathan W. Cunningham, MD, said at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

American College of Cardiology

“We’ve all been trying to unravel the explanation for the differential effects between men and women in the primary trial. I don’t know that this NT-proBNP substudy gives a clear answer because we did see similar reduction in NT-proBNP in the men and women,” said Dr. Cunningham of Brigham and Women’s Hospital, Boston.

“Unfortunately, I think we’re still looking for the underlying physiological explanation for that very interesting interaction,” he added.

The PARAGON-HF trial included 4,796 patients with heart failure with preserved ejection fraction (HFpEF) who were randomized double-blind to sacubitril/valsartan (Entresto) or valsartan on top of background guideline-directed medical therapy and followed for a median of 34 months (N Engl J Med. 2019 Oct 24;381[17]:1609-20). The sacubitril/valsartan group’s 13% relative risk reduction in the primary composite endpoint of cardiovascular death and total heart failure hospitalizations fell tantalizingly short of statistical significance (P = 0.058).

In women, however, who comprised more than half of the study population, the benefit of sacubitril/valsartan was larger: a 27% relative risk reduction compared to valsartan alone. That’s a statistically significant difference in a prespecified subgroup analysis, but according to the rules of clinical trials and statistics it must be considered hypothesis-generating and nondefinitive, since the overall trial was negative. Men randomized to sacubitril/valsartan had a modest 3% increased risk of the primary endpoint compared to men on valsartan.

Because of the enormous unmet need for effective therapy for HFpEF, and the fact that HFpEF is more common in women than men, the search is on for an explanation that would account for the striking gender difference in outcome in PARAGON-HF. At ACC 2020, Dr. Cunningham presented a secondary analysis of the trial focusing on the relationships between baseline and on-treatment N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and clinical outcomes.

Among the key findings was that the higher the baseline NT-proBNP, the greater the likelihood of the primary endpoint. Also, sacubitril/valsartan reduced NT-proBNP to a similar extent in men and women: For example, by 20% compared to valsartan in men and by 18% in women when measured 16 weeks after randomization. And reduction in NT-proBNP was associated with reduced risk of cardiovascular death and heart failure hospitalizations; indeed, 60% of participants in PARAGON-HF experienced a decrease in NT-proBNP, and they had a 23% lower event rate compared to patients whose NT-proBNP increased during the course of the study.

Another intriguing finding in the parent PARAGON-HF trial was that HFpEF patients with an LVEF of 45%-57% had a 22% lower rate of the primary endpoint than those with an LVEF of 58% or more. But as with the gender difference in clinical outcomes in response to sacubitril/valsartan, the difference in outcomes based on ejection fraction was not mediated by the drug’s impact on NT-proBNP, since sacubitril/valsartan reduced NT-proBNP to a similar degree in HFpEF patients with an LVEF above or below 57%.

The difference in outcomes by ejection fraction wasn’t entirely surprising, because those low-normal–range ejection fractions where sacubitril/valsartan had a favorable impact approach those characteristic of heart failure with reduced ejection fraction (HFrEF), and guidelines give sacubitril/valsartan a class I recommendation in patients with HFrEF on the strength of the medication’s demonstrated reduction in morbidity and mortality in the PARADIGM-HF trial.

Discussant Lee R. Goldberg, MD, predicted this analysis will have an impact on the design of future clinical trials in HFpEF, which up until now have required certain minimum NT-proBNP levels for participation.

“Maybe this is why so many of our trials in HFpEF have been unsuccessful. It’s a very heterogeneous population and perhaps NT-proBNP cutoffs are leading to a lot of mischief or heterogeneity that causes us some difficulty,” said Dr. Goldberg, professor of medicine and chief of the section of advanced heart failure and cardiac transplantation at the University of Pennsylvania, Philadelphia.

Dr. Cunningham reported having no financial conflicts regarding his study. The PARAGON-HF trial was funded by Novartis.

Simultaneously with Dr. Cunningham’s presentation at ACC 2020, the study results were published online (JACC Heart Fail. 2020 Mar 26; doi: 10.1016/j.jchf.2020.03.002.

[email protected]

SOURCE: Cunningham JW. ACC 2020, Abstract 412-08.

The explanation for the impressive clinical benefits of sacubitril/valsartan in women with heart failure with preserved ejection fraction in the PARAGON-HF trial – but not in the men – remains elusive, Jonathan W. Cunningham, MD, said at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

American College of Cardiology

“We’ve all been trying to unravel the explanation for the differential effects between men and women in the primary trial. I don’t know that this NT-proBNP substudy gives a clear answer because we did see similar reduction in NT-proBNP in the men and women,” said Dr. Cunningham of Brigham and Women’s Hospital, Boston.

“Unfortunately, I think we’re still looking for the underlying physiological explanation for that very interesting interaction,” he added.

The PARAGON-HF trial included 4,796 patients with heart failure with preserved ejection fraction (HFpEF) who were randomized double-blind to sacubitril/valsartan (Entresto) or valsartan on top of background guideline-directed medical therapy and followed for a median of 34 months (N Engl J Med. 2019 Oct 24;381[17]:1609-20). The sacubitril/valsartan group’s 13% relative risk reduction in the primary composite endpoint of cardiovascular death and total heart failure hospitalizations fell tantalizingly short of statistical significance (P = 0.058).

In women, however, who comprised more than half of the study population, the benefit of sacubitril/valsartan was larger: a 27% relative risk reduction compared to valsartan alone. That’s a statistically significant difference in a prespecified subgroup analysis, but according to the rules of clinical trials and statistics it must be considered hypothesis-generating and nondefinitive, since the overall trial was negative. Men randomized to sacubitril/valsartan had a modest 3% increased risk of the primary endpoint compared to men on valsartan.

Because of the enormous unmet need for effective therapy for HFpEF, and the fact that HFpEF is more common in women than men, the search is on for an explanation that would account for the striking gender difference in outcome in PARAGON-HF. At ACC 2020, Dr. Cunningham presented a secondary analysis of the trial focusing on the relationships between baseline and on-treatment N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and clinical outcomes.

Among the key findings was that the higher the baseline NT-proBNP, the greater the likelihood of the primary endpoint. Also, sacubitril/valsartan reduced NT-proBNP to a similar extent in men and women: For example, by 20% compared to valsartan in men and by 18% in women when measured 16 weeks after randomization. And reduction in NT-proBNP was associated with reduced risk of cardiovascular death and heart failure hospitalizations; indeed, 60% of participants in PARAGON-HF experienced a decrease in NT-proBNP, and they had a 23% lower event rate compared to patients whose NT-proBNP increased during the course of the study.

Another intriguing finding in the parent PARAGON-HF trial was that HFpEF patients with an LVEF of 45%-57% had a 22% lower rate of the primary endpoint than those with an LVEF of 58% or more. But as with the gender difference in clinical outcomes in response to sacubitril/valsartan, the difference in outcomes based on ejection fraction was not mediated by the drug’s impact on NT-proBNP, since sacubitril/valsartan reduced NT-proBNP to a similar degree in HFpEF patients with an LVEF above or below 57%.

The difference in outcomes by ejection fraction wasn’t entirely surprising, because those low-normal–range ejection fractions where sacubitril/valsartan had a favorable impact approach those characteristic of heart failure with reduced ejection fraction (HFrEF), and guidelines give sacubitril/valsartan a class I recommendation in patients with HFrEF on the strength of the medication’s demonstrated reduction in morbidity and mortality in the PARADIGM-HF trial.

Discussant Lee R. Goldberg, MD, predicted this analysis will have an impact on the design of future clinical trials in HFpEF, which up until now have required certain minimum NT-proBNP levels for participation.

“Maybe this is why so many of our trials in HFpEF have been unsuccessful. It’s a very heterogeneous population and perhaps NT-proBNP cutoffs are leading to a lot of mischief or heterogeneity that causes us some difficulty,” said Dr. Goldberg, professor of medicine and chief of the section of advanced heart failure and cardiac transplantation at the University of Pennsylvania, Philadelphia.

Dr. Cunningham reported having no financial conflicts regarding his study. The PARAGON-HF trial was funded by Novartis.

Simultaneously with Dr. Cunningham’s presentation at ACC 2020, the study results were published online (JACC Heart Fail. 2020 Mar 26; doi: 10.1016/j.jchf.2020.03.002.

[email protected]

SOURCE: Cunningham JW. ACC 2020, Abstract 412-08.

Patients infected by the COVID-19 virus may benefit from treatments that dampen the renin-angiotensin system, according to a review of several animal studies. These preclinical findings generally support the positions taken in recent week by several cardiology societies that recommended patients taking drugs that moderate the renin-angiotensin system stay on these treatments.

“In patients with cardiovascular disease and SARS-CoV2, the use of ACE inhibitors, ARBs [angiotensin receptor blockers], or MRAs [mineralocorticoid-receptor antagonists] may be favorable as a method to endogenously upregulate ACE2 as a compensatory mechanism that provides anti-inflammatory, antifibrotic, and antithrombotic support as well as reduction in progression of vascular/cardiac remodeling and heart failure,” wrote Jeffrey Bander, MD, and his associates in a report published online (J Am Coll Cardiol. 2020 Apr 15. doi: 10.1016/j.jacc.2020.04.028).

“Based on our review, we hypothesize cardiovascular patients with COVID-19 should remain on RAS [renin-angiotensin system] inhibitors given the protective effects of the ACE2 pathway until RAS blockade is proven to increase the risk to COVID-19,” said the researchers, who are affiliated with the Icahn School of Medicine at Mount Sinai in New York.

The ACE2 protein, found both in human blood as well as in cell membranes, especially cells of the lungs, heart, kidneys, and gastrointestinal tissues, functions as both a key enzyme in RAS regulation as well as the primary cell receptor for entry of SARS-CoV2.

Their conclusion jibed with both a joint statement in March from the American College of Cardiology, American Heart Association, and the Heart Failure Society of America; and with the conclusions of a review organized by the European Society of Hypertension’s COVID-19 Task Force (Cardiovasc Res. 2020 Apr 15. doi: 10.1093/cvr/cvaa097).

In their review, the Mount Sinai authors described results from several animal studies suggesting that ACE2 and its associated signaling proteins could potentially be a “valuable therapeutic target.” They also highlighted several clinical intervention studies recently launched to target ACE2, related proteins, and regulation of this arm of the RAS.

Currently, “no data support any conclusive effects of the use of RAS inhibitors in patients with COVID-19,” they concluded. They acknowledged that “the question remains whether the use of ACE inhibitors, ARBs, and MRAs should be avoided in the setting of SARS-CoV infection,” but emphasized that “adequate data on the effects of RAS inhibition in COVID-19 patients is not available,” with more data becoming available soon from ongoing clinical studies.

None of the authors had any disclosures.

[email protected]

Patients infected by the COVID-19 virus may benefit from treatments that dampen the renin-angiotensin system, according to a review of several animal studies. These preclinical findings generally support the positions taken in recent week by several cardiology societies that recommended patients taking drugs that moderate the renin-angiotensin system stay on these treatments.

“In patients with cardiovascular disease and SARS-CoV2, the use of ACE inhibitors, ARBs [angiotensin receptor blockers], or MRAs [mineralocorticoid-receptor antagonists] may be favorable as a method to endogenously upregulate ACE2 as a compensatory mechanism that provides anti-inflammatory, antifibrotic, and antithrombotic support as well as reduction in progression of vascular/cardiac remodeling and heart failure,” wrote Jeffrey Bander, MD, and his associates in a report published online (J Am Coll Cardiol. 2020 Apr 15. doi: 10.1016/j.jacc.2020.04.028).

“Based on our review, we hypothesize cardiovascular patients with COVID-19 should remain on RAS [renin-angiotensin system] inhibitors given the protective effects of the ACE2 pathway until RAS blockade is proven to increase the risk to COVID-19,” said the researchers, who are affiliated with the Icahn School of Medicine at Mount Sinai in New York.

The ACE2 protein, found both in human blood as well as in cell membranes, especially cells of the lungs, heart, kidneys, and gastrointestinal tissues, functions as both a key enzyme in RAS regulation as well as the primary cell receptor for entry of SARS-CoV2.

Their conclusion jibed with both a joint statement in March from the American College of Cardiology, American Heart Association, and the Heart Failure Society of America; and with the conclusions of a review organized by the European Society of Hypertension’s COVID-19 Task Force (Cardiovasc Res. 2020 Apr 15. doi: 10.1093/cvr/cvaa097).

In their review, the Mount Sinai authors described results from several animal studies suggesting that ACE2 and its associated signaling proteins could potentially be a “valuable therapeutic target.” They also highlighted several clinical intervention studies recently launched to target ACE2, related proteins, and regulation of this arm of the RAS.

Currently, “no data support any conclusive effects of the use of RAS inhibitors in patients with COVID-19,” they concluded. They acknowledged that “the question remains whether the use of ACE inhibitors, ARBs, and MRAs should be avoided in the setting of SARS-CoV infection,” but emphasized that “adequate data on the effects of RAS inhibition in COVID-19 patients is not available,” with more data becoming available soon from ongoing clinical studies.

None of the authors had any disclosures.

[email protected]

Patients infected by the COVID-19 virus may benefit from treatments that dampen the renin-angiotensin system, according to a review of several animal studies. These preclinical findings generally support the positions taken in recent week by several cardiology societies that recommended patients taking drugs that moderate the renin-angiotensin system stay on these treatments.

“In patients with cardiovascular disease and SARS-CoV2, the use of ACE inhibitors, ARBs [angiotensin receptor blockers], or MRAs [mineralocorticoid-receptor antagonists] may be favorable as a method to endogenously upregulate ACE2 as a compensatory mechanism that provides anti-inflammatory, antifibrotic, and antithrombotic support as well as reduction in progression of vascular/cardiac remodeling and heart failure,” wrote Jeffrey Bander, MD, and his associates in a report published online (J Am Coll Cardiol. 2020 Apr 15. doi: 10.1016/j.jacc.2020.04.028).

“Based on our review, we hypothesize cardiovascular patients with COVID-19 should remain on RAS [renin-angiotensin system] inhibitors given the protective effects of the ACE2 pathway until RAS blockade is proven to increase the risk to COVID-19,” said the researchers, who are affiliated with the Icahn School of Medicine at Mount Sinai in New York.

The ACE2 protein, found both in human blood as well as in cell membranes, especially cells of the lungs, heart, kidneys, and gastrointestinal tissues, functions as both a key enzyme in RAS regulation as well as the primary cell receptor for entry of SARS-CoV2.

Their conclusion jibed with both a joint statement in March from the American College of Cardiology, American Heart Association, and the Heart Failure Society of America; and with the conclusions of a review organized by the European Society of Hypertension’s COVID-19 Task Force (Cardiovasc Res. 2020 Apr 15. doi: 10.1093/cvr/cvaa097).

In their review, the Mount Sinai authors described results from several animal studies suggesting that ACE2 and its associated signaling proteins could potentially be a “valuable therapeutic target.” They also highlighted several clinical intervention studies recently launched to target ACE2, related proteins, and regulation of this arm of the RAS.

Currently, “no data support any conclusive effects of the use of RAS inhibitors in patients with COVID-19,” they concluded. They acknowledged that “the question remains whether the use of ACE inhibitors, ARBs, and MRAs should be avoided in the setting of SARS-CoV infection,” but emphasized that “adequate data on the effects of RAS inhibition in COVID-19 patients is not available,” with more data becoming available soon from ongoing clinical studies.

None of the authors had any disclosures.

[email protected]

Social distancing is slowing the spread of COVID-19, but it will undoubtedly have negative consequences for mental health and well-being in both the short- and long-term, public health experts say.

In an article published online April 10 in JAMA Internal Medicine on the mental health consequences of COVID-19, the authors warn of a “pandemic” of behavioral problems and mental illness.

“COVID-19 is a traumatic event that we are all experiencing. We can well expect there to be a rise in mental illness nationwide,” first author Sandro Galea, MD, dean of the School of Public Health at Boston University, said in an interview.

“Education about this, screening for those with symptoms, and availability of treatment are all important to mitigate the mental health consequences of COVID-19,” Dr. Galea added.
 

Anxiety, depression, child abuse

The COVID-19 pandemic will likely result in “substantial” increases in anxiety and depression, substance use, loneliness, and domestic violence. In addition, with school closures, the possibility of an epidemic of child abuse is “very real,” the authors noted.

As reported online, a recent national survey by the American Psychiatric Association showed COVID-19 is seriously affecting Americans’ mental health, with half of U.S. adults reporting high levels of anxiety.

The authors suggest that three steps, taken now, can help prepare for the coming mental health problems and associated problems that will result from the pandemic.

The first step is to plan for the inevitability of loneliness and its sequelae as populations physically and socially isolate and to find ways to intervene.

To prepare, the authors suggest the use of digital technologies to mitigate the impact of social distancing, even while physical distancing. They also encourage places of worship, gyms, yoga studios, and other places people normally gather to offer regularly scheduled online activities.

Employers also can help by offering virtual technologies that enable employees to work from home, and schools should develop and implement online learning for children.

“Even with all of these measures, there will still be segments of the population that are lonely and isolated. This suggests the need for remote approaches for outreach and screening for loneliness and associated mental health conditions so that social support can be provided,” the authors noted.

Need for creative thinking

The authors noted the second “critical” step is to have mechanisms in place for surveillance, reporting, and intervention, particularly when it comes to domestic violence and child abuse.

“Individuals at risk for abuse may have limited opportunities to report or seek help when shelter-in-place requirements demand prolonged cohabitation at home and limit travel outside of the home,” they wrote.

“Systems will need to balance the need for social distancing with the availability of safe places to be for people who are at risk, and social services systems will need to be creative in their approaches to following up on reports of problems,” they noted.

Finally, the authors note that now is the time to bolster the U.S. mental health system in preparation for the challenges posed by the COVID-19 pandemic.

“Scaling up treatment in the midst of crisis will take creative thinking. Communities and organizations could consider training nontraditional groups to provide psychological first aid, helping teach the lay public to check in with one another and provide support,” they wrote.

“This difficult moment in time nonetheless offers the opportunity to advance our understanding of how to provide prevention-focused, population-level, and indeed national-level psychological first aid and mental health care, and to emerge from this pandemic with new ways of doing so.”
 

Invaluable advice

Reached for comment, Lloyd I. Sederer, MD, psychiatrist and adjunct professor at Columbia University Mailman School of Public Health in New York, described the article as “invaluable” noting that it “clearly and concisely describes the mental health consequences we can expect in the wake of the COVID-19 pandemic – and what can (and needs) to be done to mitigate them.”

Dr. Sederer added that Dr. Galea has “studied and been part of the mental health responses to previous disasters, and is a leader in public health, including public mental health. His voice truly is worth listening to (and acting upon).”

Dr. Sederer offers additional suggestions on addressing mental health after disasters in a recent perspective article

Dr. Galea and Dr. Sederer have reported no relevant financial relationships.

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

Social distancing is slowing the spread of COVID-19, but it will undoubtedly have negative consequences for mental health and well-being in both the short- and long-term, public health experts say.

In an article published online April 10 in JAMA Internal Medicine on the mental health consequences of COVID-19, the authors warn of a “pandemic” of behavioral problems and mental illness.

“COVID-19 is a traumatic event that we are all experiencing. We can well expect there to be a rise in mental illness nationwide,” first author Sandro Galea, MD, dean of the School of Public Health at Boston University, said in an interview.

“Education about this, screening for those with symptoms, and availability of treatment are all important to mitigate the mental health consequences of COVID-19,” Dr. Galea added.
 

Anxiety, depression, child abuse

The COVID-19 pandemic will likely result in “substantial” increases in anxiety and depression, substance use, loneliness, and domestic violence. In addition, with school closures, the possibility of an epidemic of child abuse is “very real,” the authors noted.

As reported online, a recent national survey by the American Psychiatric Association showed COVID-19 is seriously affecting Americans’ mental health, with half of U.S. adults reporting high levels of anxiety.

The authors suggest that three steps, taken now, can help prepare for the coming mental health problems and associated problems that will result from the pandemic.

The first step is to plan for the inevitability of loneliness and its sequelae as populations physically and socially isolate and to find ways to intervene.

To prepare, the authors suggest the use of digital technologies to mitigate the impact of social distancing, even while physical distancing. They also encourage places of worship, gyms, yoga studios, and other places people normally gather to offer regularly scheduled online activities.

Employers also can help by offering virtual technologies that enable employees to work from home, and schools should develop and implement online learning for children.

“Even with all of these measures, there will still be segments of the population that are lonely and isolated. This suggests the need for remote approaches for outreach and screening for loneliness and associated mental health conditions so that social support can be provided,” the authors noted.

Need for creative thinking

The authors noted the second “critical” step is to have mechanisms in place for surveillance, reporting, and intervention, particularly when it comes to domestic violence and child abuse.

“Individuals at risk for abuse may have limited opportunities to report or seek help when shelter-in-place requirements demand prolonged cohabitation at home and limit travel outside of the home,” they wrote.

“Systems will need to balance the need for social distancing with the availability of safe places to be for people who are at risk, and social services systems will need to be creative in their approaches to following up on reports of problems,” they noted.

Finally, the authors note that now is the time to bolster the U.S. mental health system in preparation for the challenges posed by the COVID-19 pandemic.

“Scaling up treatment in the midst of crisis will take creative thinking. Communities and organizations could consider training nontraditional groups to provide psychological first aid, helping teach the lay public to check in with one another and provide support,” they wrote.

“This difficult moment in time nonetheless offers the opportunity to advance our understanding of how to provide prevention-focused, population-level, and indeed national-level psychological first aid and mental health care, and to emerge from this pandemic with new ways of doing so.”
 

Invaluable advice

Reached for comment, Lloyd I. Sederer, MD, psychiatrist and adjunct professor at Columbia University Mailman School of Public Health in New York, described the article as “invaluable” noting that it “clearly and concisely describes the mental health consequences we can expect in the wake of the COVID-19 pandemic – and what can (and needs) to be done to mitigate them.”

Dr. Sederer added that Dr. Galea has “studied and been part of the mental health responses to previous disasters, and is a leader in public health, including public mental health. His voice truly is worth listening to (and acting upon).”

Dr. Sederer offers additional suggestions on addressing mental health after disasters in a recent perspective article

Dr. Galea and Dr. Sederer have reported no relevant financial relationships.

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

Social distancing is slowing the spread of COVID-19, but it will undoubtedly have negative consequences for mental health and well-being in both the short- and long-term, public health experts say.

In an article published online April 10 in JAMA Internal Medicine on the mental health consequences of COVID-19, the authors warn of a “pandemic” of behavioral problems and mental illness.

“COVID-19 is a traumatic event that we are all experiencing. We can well expect there to be a rise in mental illness nationwide,” first author Sandro Galea, MD, dean of the School of Public Health at Boston University, said in an interview.

“Education about this, screening for those with symptoms, and availability of treatment are all important to mitigate the mental health consequences of COVID-19,” Dr. Galea added.
 

Anxiety, depression, child abuse

The COVID-19 pandemic will likely result in “substantial” increases in anxiety and depression, substance use, loneliness, and domestic violence. In addition, with school closures, the possibility of an epidemic of child abuse is “very real,” the authors noted.

As reported online, a recent national survey by the American Psychiatric Association showed COVID-19 is seriously affecting Americans’ mental health, with half of U.S. adults reporting high levels of anxiety.

The authors suggest that three steps, taken now, can help prepare for the coming mental health problems and associated problems that will result from the pandemic.

The first step is to plan for the inevitability of loneliness and its sequelae as populations physically and socially isolate and to find ways to intervene.

To prepare, the authors suggest the use of digital technologies to mitigate the impact of social distancing, even while physical distancing. They also encourage places of worship, gyms, yoga studios, and other places people normally gather to offer regularly scheduled online activities.

Employers also can help by offering virtual technologies that enable employees to work from home, and schools should develop and implement online learning for children.

“Even with all of these measures, there will still be segments of the population that are lonely and isolated. This suggests the need for remote approaches for outreach and screening for loneliness and associated mental health conditions so that social support can be provided,” the authors noted.

Need for creative thinking

The authors noted the second “critical” step is to have mechanisms in place for surveillance, reporting, and intervention, particularly when it comes to domestic violence and child abuse.

“Individuals at risk for abuse may have limited opportunities to report or seek help when shelter-in-place requirements demand prolonged cohabitation at home and limit travel outside of the home,” they wrote.

“Systems will need to balance the need for social distancing with the availability of safe places to be for people who are at risk, and social services systems will need to be creative in their approaches to following up on reports of problems,” they noted.

Finally, the authors note that now is the time to bolster the U.S. mental health system in preparation for the challenges posed by the COVID-19 pandemic.

“Scaling up treatment in the midst of crisis will take creative thinking. Communities and organizations could consider training nontraditional groups to provide psychological first aid, helping teach the lay public to check in with one another and provide support,” they wrote.

“This difficult moment in time nonetheless offers the opportunity to advance our understanding of how to provide prevention-focused, population-level, and indeed national-level psychological first aid and mental health care, and to emerge from this pandemic with new ways of doing so.”
 

Invaluable advice

Reached for comment, Lloyd I. Sederer, MD, psychiatrist and adjunct professor at Columbia University Mailman School of Public Health in New York, described the article as “invaluable” noting that it “clearly and concisely describes the mental health consequences we can expect in the wake of the COVID-19 pandemic – and what can (and needs) to be done to mitigate them.”

Dr. Sederer added that Dr. Galea has “studied and been part of the mental health responses to previous disasters, and is a leader in public health, including public mental health. His voice truly is worth listening to (and acting upon).”

Dr. Sederer offers additional suggestions on addressing mental health after disasters in a recent perspective article

Dr. Galea and Dr. Sederer have reported no relevant financial relationships.

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

Jails provide ideal conditions for the spread of COVID-19, as made clear by the distressing stories coming out of New York City. Beyond the very substantial risks posed by the virus itself, practitioners tasked with attending to the large proportion of inmates with mental illness now face additional challenges.

Medscape Psychiatry editorial director Bret Stetka, MD, spoke with Elizabeth Ford, MD, former chief of psychiatry for NYC Health + Hospitals/Correctional Health Services and current chief medical officer for the Center for Alternative Sentencing and Employment Services (CASES), a community organization focused on the needs of people touched by the criminal justice system, to find out how COVID-19 may be reshaping the mental health care of incarcerated patients. As noted by Ford, who authored the 2017 memoir Sometimes Amazing Things Happen: Heartbreak and Hope on the Bellevue Hospital Psychiatric Prison Ward, the unique vulnerabilities of this population were evident well before the coronavirus pandemic’s arrival on our shores.
 

What are the unique health and mental health challenges that can arise in correctional facilities during crises like this, in particular, infectious crises? Or are we still learning this as COVID-19 spreads?

I think it’s important to say that they are still learning it, and I don’t want to speak for them. I left Correctional Health Services on Feb. 14, and we weren’t aware of [all the risks posed by COVID-19] at that point.

I worked in the jail proper for five and a half years. Prior to that I spent a decade at Bellevue Hospital, where I took care of the same patients, who were still incarcerated but also hospitalized. In those years, the closest I ever came to managing something like this was Superstorm Sandy, which obviously had much different health implications.

All of the things that the community is struggling with in terms of the virus also apply in jails and prisons: identifying people who are sick, keeping healthy people from getting sick, preventing sick people from getting worse, separating populations, treatment options, testing options, making sure people follow the appropriate hygiene recommendations. It’s just amplified immensely because these are closed systems that tend to be poorly sanitized, crowded, and frequently forgotten or minimized in public health and political conversations.

A really important distinction is that individuals who are incarcerated do not have control over their behavior in the way that they would in the outside world. They may want to wash their hands frequently and to stay six feet away from everybody, but they can’t because the environment doesn’t allow for that. I know that everyone – correctional officers, health staff, incarcerated individuals, the city – is trying to figure out how to do those things in the jail. The primary challenge is that you don’t have the ability to do the things that you know are right to prevent the spread of the infection.
 

I know you can’t speak to what’s going on at specific jails at the moment, but what sort of psychiatric measures would a jail system put forth in a time like this?

It’s a good question, because like everybody, they’re having to balance the safety of the staff and the patients. Mental health interventions are mostly in person and very time intensive, and social distancing guidelines don’t allow for that now.

I expect that the jails are trying to stratify patients based on severity, both physical and psychological, although increasingly it’s likely harder to separate those who are sick from those who aren’t. In areas where patients are sick, I think the mental health staff are likely doing as much intervention as they can safely, including remote work like telehealth. Telehealth actually got its start in prisons, because they couldn’t get enough providers to come in and do the work in person.
 

I’ve read a lot of the criticism around this, specifically at Rikers Island, where inmates are still closely seated at dining tables, with no possibility of social distancing. [Editor’s note: At the time of this writing, Rikers Island experienced its first inmate death due to COVID-19.] But I see the other side of it. What are jails supposed to do when limited to such a confined space?

That’s correct. I think it is hard for someone who has not lived or worked intensely in these settings to understand how difficult it can be to implement even the most basic hygiene precautions. There are all sorts of efforts happening to create more space, to reduce admissions coming into the jail, to try to expedite discharges out, to offer a lot more sanitation options. I think they may have opened up a jail that was empty to allow for more space.
 

In a recent Medscape commentary, Jeffrey Lieberman, MD, from Columbia University detailed how a crisis like this may affect those in different tiers of mental illness. Interestingly, there are data showing that those with serious mental illness – schizophrenia, severe mania – often aren’t panicked by disasters. I assume that a sizable percentage of the jail population has severe mental illness, so I was curious about what your experience is, about how they may handle it psychologically.

The rate of serious mental illness in jail is roughly 16% or so, which is three or four times higher than the general population.

Although I don’t know if these kinds of crises differentially affect people with serious mental illness, I do believe very strongly that situations like this, for those who are and who are not incarcerated, can exacerbate or cause symptoms like anxiety, depression, and elevated levels of fear – fear about the unknown, fear of illness or death, fear of isolation.

For people who are incarcerated and who understandably may struggle with trusting the system that is supposed to be keeping them safe, I am concerned that this kind of situation will make that lack of trust worse. I worry that when they get out of jail they will be less inclined to seek help. I imagine that the staff in the jails are doing as much as they can to support the patients, but the staff are also likely experiencing some version of the abandonment and frustration that the patients may feel.

I’ve also seen – not in a crisis of this magnitude but in other crisis situations – that a community really develops among everybody in incarcerated settings. A shared crisis forces everybody to work together in ways that they may not have before. That includes more tolerance for behaviors, more understanding of differences, including mental illness and developmental delay. More compassion.
 

Do you mean between prisoners and staff? Among everybody?

Everybody. In all of the different relationships you can imagine.
 

That speaks to the vulnerability and good nature in all of us. It’s encouraging.

It is, although it’s devastating to me that it happens because they collectively feel so neglected and forgotten. Shared trauma can bind people together very closely.
 

What psychiatric conditions did you typically see in New York City jails?

For the many people with serious mental illness, it’s generally schizophrenia-spectrum illnesses and bipolar disorder – really severe illnesses that do not do well in confinement settings. There’s a lot of anxiety and depression, some that rises to the level of serious illness. There is near universal substance use among the population.

There is also almost universal trauma exposure, whether early-childhood experiences or the ongoing trauma of incarceration. Not everyone has PTSD, but almost everyone behaves in a traumatized way. As you know, in the United States, incarceration is very racially and socioeconomically biased; the trauma of poverty can be incredibly harsh.

What I didn’t see were lots of people with antisocial personality disorder or diagnoses of malingering. That may surprise people. There’s an idea that everybody in jail is a liar and lacks empathy. I didn’t experience that. People in jail are doing whatever they can to survive.
 

What treatments are offered to these patients?

In New York City, all of the typical treatments that you would imagine for people with serious mental illness are offered in the jails: individual and group psychotherapy, medication management, substance use treatment, social work services, even creative art therapy. Many other jails are not able to do even a fraction of that.

In many jails there also has to be a lot of supportive therapy. This involves trying to help people get through a very anxiety-provoking and difficult time, when they frequently don’t know when they are going to be able to leave. I felt the same way as many of the correction officers – that the best thing for these patients is to be out of the jail, to be out of that toxic environment.
 

We have heard for years that the jail system and prison system is the new psych ward. Can you speak to how this occurred and the influence of deinstitutionalization?

When deinstitutionalization happened, there were not enough community agencies available that were equipped to take care of patients who were previously in hospitals. But I think a larger contributor to the overpopulation of people with mental illness in jails and prisons was the war on drugs. It disproportionately affected people who were poor, of color, and who had mental illness. Mental illness and substance use frequently occur together.

At the same time as deinstitutionalization and the war on drugs, there was also a tightening up of the laws relating to admission to psychiatric hospitals. The civil rights movement helped define the requirements that someone had to be dangerous and mentally ill in order to get admitted against their will. While this was an important protection against more indiscriminate admissions of the past, it made it harder to get into hospitals; the state hospitals were closed but the hospitals that were open were now harder to get into.
 

You mentioned that prisoners are undergoing trauma every day. Is this inherent to punitive confinement, or is it something that can be improved upon in the United States?

It’s important that you said “in the United States” as part of that question. Our approach to incarceration in the U.S. is heavily punishment based.
 

Compared to somewhere like Scandinavia, where inmates and prisoners are given a lot more support?

Or England or Canada. The challenge with comparing the United States to Scandinavia is that we are socioeconomically, demographically, and politically so different. But yes, my understanding about the Scandinavian systems are that they have a much more rehabilitative approach to incarceration. Until the U.S. can reframe the goals of incarceration to focus on helping individuals behave in a socially acceptable way, rather than destroy their sense of self-worth, we will continue to see the impact of trauma on generations of lives.

Now, that doesn’t mean that every jail and prison in this country is abusive. But taking away autonomy and freedom, applying inconsistent rules, using solitary confinement, and getting limited to no access to people you love all really destroy a person’s ability to behave in a way that society has deemed acceptable.
 

Assuming that mental health professionals such as yourself have a more compassionate understanding of what’s going on psychologically with the inmates, are you often at odds with law enforcement in the philosophy behind incarceration?

That’s an interesting question. When I moved from the hospital to the jail, I thought that I would run into a lot of resistance from the correction officer staff. I just thought, we’re coming at this from a totally different perspective: I’m trying to help these people and see if there’s a way to safely get them out, and you guys want to punish them.

It turns out that I was very misguided in that view, because it seemed to me that everybody wanted to do what was right for the patient. My perspective about what’s right involved respectful care, building self-esteem, treating illness. The correction officer’s perspective seemed to be keeping them safe, making sure that they can get through the system as quickly as possible, not having them get into fights. Our perspectives may have been different, but the goals were the same. I want all that stuff that the officers want as well.

It’s important to remember that the people who work inside jails and prisons are usually not the ones who are making the policies about who goes in. I haven’t had a lot of exposure working directly with many policymakers. I imagine that my opinions might differ from theirs in some regards.
 

For those working in the U.S. psychiatric healthcare system, what do you want them to know about mental health care in the correctional setting?

Patients in correctional settings are mostly the same patients seen in the public mental health system setting. The vast majority of people who spend time in jail or prison return to the community. But there’s a difference in how patients are perceived by many mental health professionals, including psychiatrists, depending on whether they have criminal justice experience or not.

I would encourage everybody to try to keep an open mind and remember that these patients are cycling through a very difficult system, for many reasons that are at least rooted in community trauma and poverty, and that it doesn’t change the nature of who they are. It doesn’t change that they’re still human beings and they still deserve care and support and treatment.

In this country, patients with mental illness and incarceration histories are so vulnerable and are often black, brown, and poor. It’s an incredible and disturbing representation of American society. But I feel like you can help a lot by getting involved in the frequently dysfunctional criminal justice system. Psychiatrists and other providers have an opportunity to fix things from the inside out.
 

What’s your new role at CASES?

I’m the chief medical officer at CASES [Center for Alternative Sentencing and Employment Services]. It’s a large community organization that provides mental health treatment, case management, employment and education services, alternatives to incarceration, and general support for people who have experienced criminal justice involvement. CASES began operating in the 1960s, and around 2000 it began developing programs specifically addressing the connection between serious mental illness and criminal justice system involvement. For example, we take care of the patients who are coming out of the jails or prisons, or managing patients that the courts have said should go to treatment instead of incarceration.

I took the job because as conditions for individuals with serious mental illness started to improve in the jails, I started to hear more frequently from patients that they were getting better treatment in the jail than out in the community. That did not sit well with me and seemed to be almost the opposite of how it should be.

I also have never been an outpatient public psychiatrist. Most of the patients I treat live most of their lives outside of a jail or a hospital. It felt really important for me to understand the lives of these patients and to see if all of the resistance that I’ve heard from community psychiatrists about taking care of people who have been in jail is really true or not.

It was a logical transition for me. I’m following the patients and basically deinstitutionalizing [them] myself.

This article was first published on Medscape.com.

Jails provide ideal conditions for the spread of COVID-19, as made clear by the distressing stories coming out of New York City. Beyond the very substantial risks posed by the virus itself, practitioners tasked with attending to the large proportion of inmates with mental illness now face additional challenges.

Medscape Psychiatry editorial director Bret Stetka, MD, spoke with Elizabeth Ford, MD, former chief of psychiatry for NYC Health + Hospitals/Correctional Health Services and current chief medical officer for the Center for Alternative Sentencing and Employment Services (CASES), a community organization focused on the needs of people touched by the criminal justice system, to find out how COVID-19 may be reshaping the mental health care of incarcerated patients. As noted by Ford, who authored the 2017 memoir Sometimes Amazing Things Happen: Heartbreak and Hope on the Bellevue Hospital Psychiatric Prison Ward, the unique vulnerabilities of this population were evident well before the coronavirus pandemic’s arrival on our shores.
 

What are the unique health and mental health challenges that can arise in correctional facilities during crises like this, in particular, infectious crises? Or are we still learning this as COVID-19 spreads?

I think it’s important to say that they are still learning it, and I don’t want to speak for them. I left Correctional Health Services on Feb. 14, and we weren’t aware of [all the risks posed by COVID-19] at that point.

I worked in the jail proper for five and a half years. Prior to that I spent a decade at Bellevue Hospital, where I took care of the same patients, who were still incarcerated but also hospitalized. In those years, the closest I ever came to managing something like this was Superstorm Sandy, which obviously had much different health implications.

All of the things that the community is struggling with in terms of the virus also apply in jails and prisons: identifying people who are sick, keeping healthy people from getting sick, preventing sick people from getting worse, separating populations, treatment options, testing options, making sure people follow the appropriate hygiene recommendations. It’s just amplified immensely because these are closed systems that tend to be poorly sanitized, crowded, and frequently forgotten or minimized in public health and political conversations.

A really important distinction is that individuals who are incarcerated do not have control over their behavior in the way that they would in the outside world. They may want to wash their hands frequently and to stay six feet away from everybody, but they can’t because the environment doesn’t allow for that. I know that everyone – correctional officers, health staff, incarcerated individuals, the city – is trying to figure out how to do those things in the jail. The primary challenge is that you don’t have the ability to do the things that you know are right to prevent the spread of the infection.
 

I know you can’t speak to what’s going on at specific jails at the moment, but what sort of psychiatric measures would a jail system put forth in a time like this?

It’s a good question, because like everybody, they’re having to balance the safety of the staff and the patients. Mental health interventions are mostly in person and very time intensive, and social distancing guidelines don’t allow for that now.

I expect that the jails are trying to stratify patients based on severity, both physical and psychological, although increasingly it’s likely harder to separate those who are sick from those who aren’t. In areas where patients are sick, I think the mental health staff are likely doing as much intervention as they can safely, including remote work like telehealth. Telehealth actually got its start in prisons, because they couldn’t get enough providers to come in and do the work in person.
 

I’ve read a lot of the criticism around this, specifically at Rikers Island, where inmates are still closely seated at dining tables, with no possibility of social distancing. [Editor’s note: At the time of this writing, Rikers Island experienced its first inmate death due to COVID-19.] But I see the other side of it. What are jails supposed to do when limited to such a confined space?

That’s correct. I think it is hard for someone who has not lived or worked intensely in these settings to understand how difficult it can be to implement even the most basic hygiene precautions. There are all sorts of efforts happening to create more space, to reduce admissions coming into the jail, to try to expedite discharges out, to offer a lot more sanitation options. I think they may have opened up a jail that was empty to allow for more space.
 

In a recent Medscape commentary, Jeffrey Lieberman, MD, from Columbia University detailed how a crisis like this may affect those in different tiers of mental illness. Interestingly, there are data showing that those with serious mental illness – schizophrenia, severe mania – often aren’t panicked by disasters. I assume that a sizable percentage of the jail population has severe mental illness, so I was curious about what your experience is, about how they may handle it psychologically.

The rate of serious mental illness in jail is roughly 16% or so, which is three or four times higher than the general population.

Although I don’t know if these kinds of crises differentially affect people with serious mental illness, I do believe very strongly that situations like this, for those who are and who are not incarcerated, can exacerbate or cause symptoms like anxiety, depression, and elevated levels of fear – fear about the unknown, fear of illness or death, fear of isolation.

For people who are incarcerated and who understandably may struggle with trusting the system that is supposed to be keeping them safe, I am concerned that this kind of situation will make that lack of trust worse. I worry that when they get out of jail they will be less inclined to seek help. I imagine that the staff in the jails are doing as much as they can to support the patients, but the staff are also likely experiencing some version of the abandonment and frustration that the patients may feel.

I’ve also seen – not in a crisis of this magnitude but in other crisis situations – that a community really develops among everybody in incarcerated settings. A shared crisis forces everybody to work together in ways that they may not have before. That includes more tolerance for behaviors, more understanding of differences, including mental illness and developmental delay. More compassion.
 

Do you mean between prisoners and staff? Among everybody?

Everybody. In all of the different relationships you can imagine.
 

That speaks to the vulnerability and good nature in all of us. It’s encouraging.

It is, although it’s devastating to me that it happens because they collectively feel so neglected and forgotten. Shared trauma can bind people together very closely.
 

What psychiatric conditions did you typically see in New York City jails?

For the many people with serious mental illness, it’s generally schizophrenia-spectrum illnesses and bipolar disorder – really severe illnesses that do not do well in confinement settings. There’s a lot of anxiety and depression, some that rises to the level of serious illness. There is near universal substance use among the population.

There is also almost universal trauma exposure, whether early-childhood experiences or the ongoing trauma of incarceration. Not everyone has PTSD, but almost everyone behaves in a traumatized way. As you know, in the United States, incarceration is very racially and socioeconomically biased; the trauma of poverty can be incredibly harsh.

What I didn’t see were lots of people with antisocial personality disorder or diagnoses of malingering. That may surprise people. There’s an idea that everybody in jail is a liar and lacks empathy. I didn’t experience that. People in jail are doing whatever they can to survive.
 

What treatments are offered to these patients?

In New York City, all of the typical treatments that you would imagine for people with serious mental illness are offered in the jails: individual and group psychotherapy, medication management, substance use treatment, social work services, even creative art therapy. Many other jails are not able to do even a fraction of that.

In many jails there also has to be a lot of supportive therapy. This involves trying to help people get through a very anxiety-provoking and difficult time, when they frequently don’t know when they are going to be able to leave. I felt the same way as many of the correction officers – that the best thing for these patients is to be out of the jail, to be out of that toxic environment.
 

We have heard for years that the jail system and prison system is the new psych ward. Can you speak to how this occurred and the influence of deinstitutionalization?

When deinstitutionalization happened, there were not enough community agencies available that were equipped to take care of patients who were previously in hospitals. But I think a larger contributor to the overpopulation of people with mental illness in jails and prisons was the war on drugs. It disproportionately affected people who were poor, of color, and who had mental illness. Mental illness and substance use frequently occur together.

At the same time as deinstitutionalization and the war on drugs, there was also a tightening up of the laws relating to admission to psychiatric hospitals. The civil rights movement helped define the requirements that someone had to be dangerous and mentally ill in order to get admitted against their will. While this was an important protection against more indiscriminate admissions of the past, it made it harder to get into hospitals; the state hospitals were closed but the hospitals that were open were now harder to get into.
 

You mentioned that prisoners are undergoing trauma every day. Is this inherent to punitive confinement, or is it something that can be improved upon in the United States?

It’s important that you said “in the United States” as part of that question. Our approach to incarceration in the U.S. is heavily punishment based.
 

Compared to somewhere like Scandinavia, where inmates and prisoners are given a lot more support?

Or England or Canada. The challenge with comparing the United States to Scandinavia is that we are socioeconomically, demographically, and politically so different. But yes, my understanding about the Scandinavian systems are that they have a much more rehabilitative approach to incarceration. Until the U.S. can reframe the goals of incarceration to focus on helping individuals behave in a socially acceptable way, rather than destroy their sense of self-worth, we will continue to see the impact of trauma on generations of lives.

Now, that doesn’t mean that every jail and prison in this country is abusive. But taking away autonomy and freedom, applying inconsistent rules, using solitary confinement, and getting limited to no access to people you love all really destroy a person’s ability to behave in a way that society has deemed acceptable.
 

Assuming that mental health professionals such as yourself have a more compassionate understanding of what’s going on psychologically with the inmates, are you often at odds with law enforcement in the philosophy behind incarceration?

That’s an interesting question. When I moved from the hospital to the jail, I thought that I would run into a lot of resistance from the correction officer staff. I just thought, we’re coming at this from a totally different perspective: I’m trying to help these people and see if there’s a way to safely get them out, and you guys want to punish them.

It turns out that I was very misguided in that view, because it seemed to me that everybody wanted to do what was right for the patient. My perspective about what’s right involved respectful care, building self-esteem, treating illness. The correction officer’s perspective seemed to be keeping them safe, making sure that they can get through the system as quickly as possible, not having them get into fights. Our perspectives may have been different, but the goals were the same. I want all that stuff that the officers want as well.

It’s important to remember that the people who work inside jails and prisons are usually not the ones who are making the policies about who goes in. I haven’t had a lot of exposure working directly with many policymakers. I imagine that my opinions might differ from theirs in some regards.
 

For those working in the U.S. psychiatric healthcare system, what do you want them to know about mental health care in the correctional setting?

Patients in correctional settings are mostly the same patients seen in the public mental health system setting. The vast majority of people who spend time in jail or prison return to the community. But there’s a difference in how patients are perceived by many mental health professionals, including psychiatrists, depending on whether they have criminal justice experience or not.

I would encourage everybody to try to keep an open mind and remember that these patients are cycling through a very difficult system, for many reasons that are at least rooted in community trauma and poverty, and that it doesn’t change the nature of who they are. It doesn’t change that they’re still human beings and they still deserve care and support and treatment.

In this country, patients with mental illness and incarceration histories are so vulnerable and are often black, brown, and poor. It’s an incredible and disturbing representation of American society. But I feel like you can help a lot by getting involved in the frequently dysfunctional criminal justice system. Psychiatrists and other providers have an opportunity to fix things from the inside out.
 

What’s your new role at CASES?

I’m the chief medical officer at CASES [Center for Alternative Sentencing and Employment Services]. It’s a large community organization that provides mental health treatment, case management, employment and education services, alternatives to incarceration, and general support for people who have experienced criminal justice involvement. CASES began operating in the 1960s, and around 2000 it began developing programs specifically addressing the connection between serious mental illness and criminal justice system involvement. For example, we take care of the patients who are coming out of the jails or prisons, or managing patients that the courts have said should go to treatment instead of incarceration.

I took the job because as conditions for individuals with serious mental illness started to improve in the jails, I started to hear more frequently from patients that they were getting better treatment in the jail than out in the community. That did not sit well with me and seemed to be almost the opposite of how it should be.

I also have never been an outpatient public psychiatrist. Most of the patients I treat live most of their lives outside of a jail or a hospital. It felt really important for me to understand the lives of these patients and to see if all of the resistance that I’ve heard from community psychiatrists about taking care of people who have been in jail is really true or not.

It was a logical transition for me. I’m following the patients and basically deinstitutionalizing [them] myself.

This article was first published on Medscape.com.

Jails provide ideal conditions for the spread of COVID-19, as made clear by the distressing stories coming out of New York City. Beyond the very substantial risks posed by the virus itself, practitioners tasked with attending to the large proportion of inmates with mental illness now face additional challenges.

Medscape Psychiatry editorial director Bret Stetka, MD, spoke with Elizabeth Ford, MD, former chief of psychiatry for NYC Health + Hospitals/Correctional Health Services and current chief medical officer for the Center for Alternative Sentencing and Employment Services (CASES), a community organization focused on the needs of people touched by the criminal justice system, to find out how COVID-19 may be reshaping the mental health care of incarcerated patients. As noted by Ford, who authored the 2017 memoir Sometimes Amazing Things Happen: Heartbreak and Hope on the Bellevue Hospital Psychiatric Prison Ward, the unique vulnerabilities of this population were evident well before the coronavirus pandemic’s arrival on our shores.
 

What are the unique health and mental health challenges that can arise in correctional facilities during crises like this, in particular, infectious crises? Or are we still learning this as COVID-19 spreads?

I think it’s important to say that they are still learning it, and I don’t want to speak for them. I left Correctional Health Services on Feb. 14, and we weren’t aware of [all the risks posed by COVID-19] at that point.

I worked in the jail proper for five and a half years. Prior to that I spent a decade at Bellevue Hospital, where I took care of the same patients, who were still incarcerated but also hospitalized. In those years, the closest I ever came to managing something like this was Superstorm Sandy, which obviously had much different health implications.

All of the things that the community is struggling with in terms of the virus also apply in jails and prisons: identifying people who are sick, keeping healthy people from getting sick, preventing sick people from getting worse, separating populations, treatment options, testing options, making sure people follow the appropriate hygiene recommendations. It’s just amplified immensely because these are closed systems that tend to be poorly sanitized, crowded, and frequently forgotten or minimized in public health and political conversations.

A really important distinction is that individuals who are incarcerated do not have control over their behavior in the way that they would in the outside world. They may want to wash their hands frequently and to stay six feet away from everybody, but they can’t because the environment doesn’t allow for that. I know that everyone – correctional officers, health staff, incarcerated individuals, the city – is trying to figure out how to do those things in the jail. The primary challenge is that you don’t have the ability to do the things that you know are right to prevent the spread of the infection.
 

I know you can’t speak to what’s going on at specific jails at the moment, but what sort of psychiatric measures would a jail system put forth in a time like this?

It’s a good question, because like everybody, they’re having to balance the safety of the staff and the patients. Mental health interventions are mostly in person and very time intensive, and social distancing guidelines don’t allow for that now.

I expect that the jails are trying to stratify patients based on severity, both physical and psychological, although increasingly it’s likely harder to separate those who are sick from those who aren’t. In areas where patients are sick, I think the mental health staff are likely doing as much intervention as they can safely, including remote work like telehealth. Telehealth actually got its start in prisons, because they couldn’t get enough providers to come in and do the work in person.
 

I’ve read a lot of the criticism around this, specifically at Rikers Island, where inmates are still closely seated at dining tables, with no possibility of social distancing. [Editor’s note: At the time of this writing, Rikers Island experienced its first inmate death due to COVID-19.] But I see the other side of it. What are jails supposed to do when limited to such a confined space?

That’s correct. I think it is hard for someone who has not lived or worked intensely in these settings to understand how difficult it can be to implement even the most basic hygiene precautions. There are all sorts of efforts happening to create more space, to reduce admissions coming into the jail, to try to expedite discharges out, to offer a lot more sanitation options. I think they may have opened up a jail that was empty to allow for more space.
 

In a recent Medscape commentary, Jeffrey Lieberman, MD, from Columbia University detailed how a crisis like this may affect those in different tiers of mental illness. Interestingly, there are data showing that those with serious mental illness – schizophrenia, severe mania – often aren’t panicked by disasters. I assume that a sizable percentage of the jail population has severe mental illness, so I was curious about what your experience is, about how they may handle it psychologically.

The rate of serious mental illness in jail is roughly 16% or so, which is three or four times higher than the general population.

Although I don’t know if these kinds of crises differentially affect people with serious mental illness, I do believe very strongly that situations like this, for those who are and who are not incarcerated, can exacerbate or cause symptoms like anxiety, depression, and elevated levels of fear – fear about the unknown, fear of illness or death, fear of isolation.

For people who are incarcerated and who understandably may struggle with trusting the system that is supposed to be keeping them safe, I am concerned that this kind of situation will make that lack of trust worse. I worry that when they get out of jail they will be less inclined to seek help. I imagine that the staff in the jails are doing as much as they can to support the patients, but the staff are also likely experiencing some version of the abandonment and frustration that the patients may feel.

I’ve also seen – not in a crisis of this magnitude but in other crisis situations – that a community really develops among everybody in incarcerated settings. A shared crisis forces everybody to work together in ways that they may not have before. That includes more tolerance for behaviors, more understanding of differences, including mental illness and developmental delay. More compassion.
 

Do you mean between prisoners and staff? Among everybody?

Everybody. In all of the different relationships you can imagine.
 

That speaks to the vulnerability and good nature in all of us. It’s encouraging.

It is, although it’s devastating to me that it happens because they collectively feel so neglected and forgotten. Shared trauma can bind people together very closely.
 

What psychiatric conditions did you typically see in New York City jails?

For the many people with serious mental illness, it’s generally schizophrenia-spectrum illnesses and bipolar disorder – really severe illnesses that do not do well in confinement settings. There’s a lot of anxiety and depression, some that rises to the level of serious illness. There is near universal substance use among the population.

There is also almost universal trauma exposure, whether early-childhood experiences or the ongoing trauma of incarceration. Not everyone has PTSD, but almost everyone behaves in a traumatized way. As you know, in the United States, incarceration is very racially and socioeconomically biased; the trauma of poverty can be incredibly harsh.

What I didn’t see were lots of people with antisocial personality disorder or diagnoses of malingering. That may surprise people. There’s an idea that everybody in jail is a liar and lacks empathy. I didn’t experience that. People in jail are doing whatever they can to survive.
 

What treatments are offered to these patients?

In New York City, all of the typical treatments that you would imagine for people with serious mental illness are offered in the jails: individual and group psychotherapy, medication management, substance use treatment, social work services, even creative art therapy. Many other jails are not able to do even a fraction of that.

In many jails there also has to be a lot of supportive therapy. This involves trying to help people get through a very anxiety-provoking and difficult time, when they frequently don’t know when they are going to be able to leave. I felt the same way as many of the correction officers – that the best thing for these patients is to be out of the jail, to be out of that toxic environment.
 

We have heard for years that the jail system and prison system is the new psych ward. Can you speak to how this occurred and the influence of deinstitutionalization?

When deinstitutionalization happened, there were not enough community agencies available that were equipped to take care of patients who were previously in hospitals. But I think a larger contributor to the overpopulation of people with mental illness in jails and prisons was the war on drugs. It disproportionately affected people who were poor, of color, and who had mental illness. Mental illness and substance use frequently occur together.

At the same time as deinstitutionalization and the war on drugs, there was also a tightening up of the laws relating to admission to psychiatric hospitals. The civil rights movement helped define the requirements that someone had to be dangerous and mentally ill in order to get admitted against their will. While this was an important protection against more indiscriminate admissions of the past, it made it harder to get into hospitals; the state hospitals were closed but the hospitals that were open were now harder to get into.
 

You mentioned that prisoners are undergoing trauma every day. Is this inherent to punitive confinement, or is it something that can be improved upon in the United States?

It’s important that you said “in the United States” as part of that question. Our approach to incarceration in the U.S. is heavily punishment based.
 

Compared to somewhere like Scandinavia, where inmates and prisoners are given a lot more support?

Or England or Canada. The challenge with comparing the United States to Scandinavia is that we are socioeconomically, demographically, and politically so different. But yes, my understanding about the Scandinavian systems are that they have a much more rehabilitative approach to incarceration. Until the U.S. can reframe the goals of incarceration to focus on helping individuals behave in a socially acceptable way, rather than destroy their sense of self-worth, we will continue to see the impact of trauma on generations of lives.

Now, that doesn’t mean that every jail and prison in this country is abusive. But taking away autonomy and freedom, applying inconsistent rules, using solitary confinement, and getting limited to no access to people you love all really destroy a person’s ability to behave in a way that society has deemed acceptable.
 

Assuming that mental health professionals such as yourself have a more compassionate understanding of what’s going on psychologically with the inmates, are you often at odds with law enforcement in the philosophy behind incarceration?

That’s an interesting question. When I moved from the hospital to the jail, I thought that I would run into a lot of resistance from the correction officer staff. I just thought, we’re coming at this from a totally different perspective: I’m trying to help these people and see if there’s a way to safely get them out, and you guys want to punish them.

It turns out that I was very misguided in that view, because it seemed to me that everybody wanted to do what was right for the patient. My perspective about what’s right involved respectful care, building self-esteem, treating illness. The correction officer’s perspective seemed to be keeping them safe, making sure that they can get through the system as quickly as possible, not having them get into fights. Our perspectives may have been different, but the goals were the same. I want all that stuff that the officers want as well.

It’s important to remember that the people who work inside jails and prisons are usually not the ones who are making the policies about who goes in. I haven’t had a lot of exposure working directly with many policymakers. I imagine that my opinions might differ from theirs in some regards.
 

For those working in the U.S. psychiatric healthcare system, what do you want them to know about mental health care in the correctional setting?

Patients in correctional settings are mostly the same patients seen in the public mental health system setting. The vast majority of people who spend time in jail or prison return to the community. But there’s a difference in how patients are perceived by many mental health professionals, including psychiatrists, depending on whether they have criminal justice experience or not.

I would encourage everybody to try to keep an open mind and remember that these patients are cycling through a very difficult system, for many reasons that are at least rooted in community trauma and poverty, and that it doesn’t change the nature of who they are. It doesn’t change that they’re still human beings and they still deserve care and support and treatment.

In this country, patients with mental illness and incarceration histories are so vulnerable and are often black, brown, and poor. It’s an incredible and disturbing representation of American society. But I feel like you can help a lot by getting involved in the frequently dysfunctional criminal justice system. Psychiatrists and other providers have an opportunity to fix things from the inside out.
 

What’s your new role at CASES?

I’m the chief medical officer at CASES [Center for Alternative Sentencing and Employment Services]. It’s a large community organization that provides mental health treatment, case management, employment and education services, alternatives to incarceration, and general support for people who have experienced criminal justice involvement. CASES began operating in the 1960s, and around 2000 it began developing programs specifically addressing the connection between serious mental illness and criminal justice system involvement. For example, we take care of the patients who are coming out of the jails or prisons, or managing patients that the courts have said should go to treatment instead of incarceration.

I took the job because as conditions for individuals with serious mental illness started to improve in the jails, I started to hear more frequently from patients that they were getting better treatment in the jail than out in the community. That did not sit well with me and seemed to be almost the opposite of how it should be.

I also have never been an outpatient public psychiatrist. Most of the patients I treat live most of their lives outside of a jail or a hospital. It felt really important for me to understand the lives of these patients and to see if all of the resistance that I’ve heard from community psychiatrists about taking care of people who have been in jail is really true or not.

It was a logical transition for me. I’m following the patients and basically deinstitutionalizing [them] myself.

This article was first published on Medscape.com.

Among patients who had an out-of-hospital cardiac arrest, intravenous sodium nitrite given by paramedics during resuscitation did not significantly improve their chances of being admitted to or discharged from the hospital alive.

The study was presented at the recent “virtual” American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology (WCC).

Lead investigator Francis Kim, MD, professor of medicine at the University of Washington, Seattle, explained that sodium nitrate is an antioxidant; animal studies have suggested that under conditions of hypoxia, it is converted into the vasodilator nitric oxide, which can increase blood flow to the brain and heart tissues.

In animal models of cardiac arrest, the use of sodium nitrite during resuscitation increased survival by almost 50%.

For the current study, 1,502 patients who had an out-of-hospital cardiac arrest were randomly assigned to receive either a low dose (45 mg) or a high dose (60 mg) of sodium nitrite or a placebo. The average age of the patients who were included in the study was 64 years, and 66% were male; 22% had ventricular fibrillation, 43% had asystole, and 29% had pulseless electrical activity.

Results showed no statistically significant differences between the groups who received placebo, low-dose sodium nitrite, or high-dose sodium nitrite on survival to hospital admission (the primary endpoint) or on hospital discharge (the secondary endpoint). There was also no difference in either endpoint in the subgroup with ventricular fibrillation.

“Our results are disappointing, especially after the promising findings in animal studies, but we feel this trial shuts the door on using this drug in this indication,” Kim said.

Discussing the study at an ACC press conference, Dhanunjaya Lakkireddy, MD, University of Kansas Hospital and Medical Center and ACC Electrophysiology Council chair, said this was “an excellent trial in the unending quest to try to improve survival in out-of-hospital cardiac arrest.

“As we all aware, if we don’t get blood circulation to the brain for more than 5 seconds, we pass out, and if don’t get blood circulation to the brain for more than 5 minutes, brain death occurs. When people suffer out-of-hospital cardiac arrest, the rate of survival is therefore dramatically lower when the ability to resuscitate goes beyond 5 minutes,” Lakkireddy noted.

He questioned why the current trial showed no effect when there had been significant early promise in animal studies. He suggested factors that could have been relevant included the time to intervention ― which was an average of 22 minutes from call to randomization ― perfusion of the brain, whether the drug cleared the blood-brain barrier, whether nitric oxide levels in the brain were sufficient, and the patient population that was included in the study.

“A large percentage of patients had asystole or pulseless electrical activity ― these are known to have worse outcomes ― and 60% of patients in the study did not have a witnessed arrest and could have been down for much longer and therefore could have had a significantly higher level of irreversible brain damage,” Lakkireddy pointed out.

“If we can understand some of the issues, we may be able to do another trial in a different subset of patients in whom the duration of arrest is significantly lower,” he commented.

The study was funded by the National Heart, Lung, and Blood Institute. Kim has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Among patients who had an out-of-hospital cardiac arrest, intravenous sodium nitrite given by paramedics during resuscitation did not significantly improve their chances of being admitted to or discharged from the hospital alive.

The study was presented at the recent “virtual” American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology (WCC).

Lead investigator Francis Kim, MD, professor of medicine at the University of Washington, Seattle, explained that sodium nitrate is an antioxidant; animal studies have suggested that under conditions of hypoxia, it is converted into the vasodilator nitric oxide, which can increase blood flow to the brain and heart tissues.

In animal models of cardiac arrest, the use of sodium nitrite during resuscitation increased survival by almost 50%.

For the current study, 1,502 patients who had an out-of-hospital cardiac arrest were randomly assigned to receive either a low dose (45 mg) or a high dose (60 mg) of sodium nitrite or a placebo. The average age of the patients who were included in the study was 64 years, and 66% were male; 22% had ventricular fibrillation, 43% had asystole, and 29% had pulseless electrical activity.

Results showed no statistically significant differences between the groups who received placebo, low-dose sodium nitrite, or high-dose sodium nitrite on survival to hospital admission (the primary endpoint) or on hospital discharge (the secondary endpoint). There was also no difference in either endpoint in the subgroup with ventricular fibrillation.

“Our results are disappointing, especially after the promising findings in animal studies, but we feel this trial shuts the door on using this drug in this indication,” Kim said.

Discussing the study at an ACC press conference, Dhanunjaya Lakkireddy, MD, University of Kansas Hospital and Medical Center and ACC Electrophysiology Council chair, said this was “an excellent trial in the unending quest to try to improve survival in out-of-hospital cardiac arrest.

“As we all aware, if we don’t get blood circulation to the brain for more than 5 seconds, we pass out, and if don’t get blood circulation to the brain for more than 5 minutes, brain death occurs. When people suffer out-of-hospital cardiac arrest, the rate of survival is therefore dramatically lower when the ability to resuscitate goes beyond 5 minutes,” Lakkireddy noted.

He questioned why the current trial showed no effect when there had been significant early promise in animal studies. He suggested factors that could have been relevant included the time to intervention ― which was an average of 22 minutes from call to randomization ― perfusion of the brain, whether the drug cleared the blood-brain barrier, whether nitric oxide levels in the brain were sufficient, and the patient population that was included in the study.

“A large percentage of patients had asystole or pulseless electrical activity ― these are known to have worse outcomes ― and 60% of patients in the study did not have a witnessed arrest and could have been down for much longer and therefore could have had a significantly higher level of irreversible brain damage,” Lakkireddy pointed out.

“If we can understand some of the issues, we may be able to do another trial in a different subset of patients in whom the duration of arrest is significantly lower,” he commented.

The study was funded by the National Heart, Lung, and Blood Institute. Kim has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Among patients who had an out-of-hospital cardiac arrest, intravenous sodium nitrite given by paramedics during resuscitation did not significantly improve their chances of being admitted to or discharged from the hospital alive.

The study was presented at the recent “virtual” American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology (WCC).

Lead investigator Francis Kim, MD, professor of medicine at the University of Washington, Seattle, explained that sodium nitrate is an antioxidant; animal studies have suggested that under conditions of hypoxia, it is converted into the vasodilator nitric oxide, which can increase blood flow to the brain and heart tissues.

In animal models of cardiac arrest, the use of sodium nitrite during resuscitation increased survival by almost 50%.

For the current study, 1,502 patients who had an out-of-hospital cardiac arrest were randomly assigned to receive either a low dose (45 mg) or a high dose (60 mg) of sodium nitrite or a placebo. The average age of the patients who were included in the study was 64 years, and 66% were male; 22% had ventricular fibrillation, 43% had asystole, and 29% had pulseless electrical activity.

Results showed no statistically significant differences between the groups who received placebo, low-dose sodium nitrite, or high-dose sodium nitrite on survival to hospital admission (the primary endpoint) or on hospital discharge (the secondary endpoint). There was also no difference in either endpoint in the subgroup with ventricular fibrillation.

“Our results are disappointing, especially after the promising findings in animal studies, but we feel this trial shuts the door on using this drug in this indication,” Kim said.

Discussing the study at an ACC press conference, Dhanunjaya Lakkireddy, MD, University of Kansas Hospital and Medical Center and ACC Electrophysiology Council chair, said this was “an excellent trial in the unending quest to try to improve survival in out-of-hospital cardiac arrest.

“As we all aware, if we don’t get blood circulation to the brain for more than 5 seconds, we pass out, and if don’t get blood circulation to the brain for more than 5 minutes, brain death occurs. When people suffer out-of-hospital cardiac arrest, the rate of survival is therefore dramatically lower when the ability to resuscitate goes beyond 5 minutes,” Lakkireddy noted.

He questioned why the current trial showed no effect when there had been significant early promise in animal studies. He suggested factors that could have been relevant included the time to intervention ― which was an average of 22 minutes from call to randomization ― perfusion of the brain, whether the drug cleared the blood-brain barrier, whether nitric oxide levels in the brain were sufficient, and the patient population that was included in the study.

“A large percentage of patients had asystole or pulseless electrical activity ― these are known to have worse outcomes ― and 60% of patients in the study did not have a witnessed arrest and could have been down for much longer and therefore could have had a significantly higher level of irreversible brain damage,” Lakkireddy pointed out.

“If we can understand some of the issues, we may be able to do another trial in a different subset of patients in whom the duration of arrest is significantly lower,” he commented.

The study was funded by the National Heart, Lung, and Blood Institute. Kim has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.