Hospital mergers and acquisitions continue to garner intense scrutiny from lawmakers, with pressure likely to hold steady following the recent announcement of new antitrust guidelines and state and federal investigations into potential healthcare monopolies.
In December, the US Department of Justice (DOJ) and the Federal Trade Commission (FTC) released updated guidelines outlining the factors they consider when determining if a merger illegally monopolizes a local healthcare market or jeopardizes access to critical healthcare services.
While the impact of the latest guidelines is yet to be seen, concerns over healthcare market consolidation are not new. Over the past two decades, mergers have attracted attention for contributing to a decline in independent hospitals, said Rachel M. Werner, MD, PhD, executive director of the Leonard Davis Institute of Health Economics at the University of Pennsylvania, Philadelphia, Pennsylvania.
“At this point, most hospitals are operating in a pretty concentrated market,” she said.
Here are five things to know about the current state of hospital mergers.
1. Record-Breaking Merger Enforcements
The DOJ and FTC reported the highest level of enforcement activity in over 20 years in fiscal year 2022 — the latest available data. Together, the agencies filed 50 merger enforcement actions and brought a record-breaking number of merger enforcement challenges, resulting in 11 approved actions, the restructuring or abandonment of seven mergers, and six business deals entering litigation.
Included in those statistics was a proposed merger between the two largest health systems in Rhode Island, Lifespan and Care New England Health System, which was abandoned after the FTC and the state Attorney General took steps to block it. the HCA branch in Utah Healthcare abandoned plans for to acquire five Salt Lake City area hospitals from competitor Steward Health Care System, as did RWJBarnabas Health after exploring a merger with Saint Peter's Healthcare System in New Jersey.
2. New Antitrust Guidelines Consider Labor Market
The new guidelines notably focus on labor competition, said Jody Boudreault, JD, attorney and chair of the Antitrust Life Sciences and Healthcare Group at Baker Botts law firm in Washington, DC. Health professionals typically have more employment opportunities in an urban area, unless hindered by restrictive noncompete agreements, and fewer options in rural settings.
In the Lifespan merger that fell through, Ms. Boudreault said that the newly created hospital system would have employed two thirds of Rhode Island's full-time nurses, limiting opportunities for local employment elsewhere.
“Going forward, I would expect federal authorities to review not only the competitive impact of the hospitals merging but also the competitive impact of the physician, and especially nursing, workforce,” she said.
FTC Chair Lina M. Khan noted similar labor market concerns.
In a statement to Congress, she said that hospital consolidation reduces options for employees, who fear “being blacklisted from further hiring in a system that controls many of the hospitals in the area” and “makes workers afraid to file complaints, organize their workplace, or leave before the end of a contract.”
3. Mergers Can Drive Care Costs Higher
When hospital markets become less competitive, the cost of care often increases. In Indiana, inpatient prices rose 13% in hospitals that merged. Another study found that prices at monopoly hospitals are 12% higher than in markets with four or more rivals. Even cross-market mergers, when hospitals in different geographic locations combine, can drive prices higher.
Dr. Werner told this news organization that more significant price hikes of 20-30% aren’t unheard of, with reimbursements by some commercial insurance companies rising as much as 50%. “That’s the direct price that the insurers pay, but the burden of those higher prices ultimately falls on patients through higher premiums,” she said.
Still, the American Hospital Association (AHA) says that mergers and acquisitions can significantly lower annual operating expenses per admission and reduce inpatient readmission rates and mortality measures. In comments to the FTC, the AHA stated that mergers could provide a lifeline for rural and community hospitals struggling with shrinking payer reimbursement and rising labor and supply costs. The business arrangements also could ensure these communities maintain continuity of care.
“In the long run, it’s not clear that it is good for patients because we start to see decreased access to some types of service, like labor and delivery, which are services needed in rural markets,” she said.
4. Mergers to Watch in 2024
Ms. Boudreault, who represented RWJBarnabas in the abandoned Saint Peter’s transaction, says the courts widely accepted the old merger guidelines, and it will take time to see how the new measures are interpreted. “The guidelines don’t yet have the force of law, but they can be persuasive to a court.”
Looking ahead, she is watching how Steward Health Care navigates its impending financial collapse. The nation’s largest private for-profit health system was previously owned by private equity firm Cerberus Capital Management and includes nine Massachusetts hospitals plus entities in at least seven other states.
Ms. Boudreault also plans to monitor Jefferson Health’s intent to merge with Lehigh Valley Health Network. “It’s a pretty big deal because they would become a 30-hospital system,” said Ms. Boudreault. The newly formed network would become the largest employer in Philadelphia.
5. Merger and Acquisition Reversals Unlikely
Dr. Werner said that mergers and acquisitions are complicated business moves that are nearly impossible to undo once approved, so it makes sense for agencies to continue to evaluate them closely.
“The costs of healthcare are borne by us as a society,” she said. “We’re going to have to live with the ill effects of a consolidated market once we let hospitals merge, so they deserve additional scrutiny.”
A version of this article appeared on Medscape.com.
Hospital mergers and acquisitions continue to garner intense scrutiny from lawmakers, with pressure likely to hold steady following the recent announcement of new antitrust guidelines and state and federal investigations into potential healthcare monopolies.
In December, the US Department of Justice (DOJ) and the Federal Trade Commission (FTC) released updated guidelines outlining the factors they consider when determining if a merger illegally monopolizes a local healthcare market or jeopardizes access to critical healthcare services.
While the impact of the latest guidelines is yet to be seen, concerns over healthcare market consolidation are not new. Over the past two decades, mergers have attracted attention for contributing to a decline in independent hospitals, said Rachel M. Werner, MD, PhD, executive director of the Leonard Davis Institute of Health Economics at the University of Pennsylvania, Philadelphia, Pennsylvania.
“At this point, most hospitals are operating in a pretty concentrated market,” she said.
Here are five things to know about the current state of hospital mergers.
1. Record-Breaking Merger Enforcements
The DOJ and FTC reported the highest level of enforcement activity in over 20 years in fiscal year 2022 — the latest available data. Together, the agencies filed 50 merger enforcement actions and brought a record-breaking number of merger enforcement challenges, resulting in 11 approved actions, the restructuring or abandonment of seven mergers, and six business deals entering litigation.
Included in those statistics was a proposed merger between the two largest health systems in Rhode Island, Lifespan and Care New England Health System, which was abandoned after the FTC and the state Attorney General took steps to block it. the HCA branch in Utah Healthcare abandoned plans for to acquire five Salt Lake City area hospitals from competitor Steward Health Care System, as did RWJBarnabas Health after exploring a merger with Saint Peter's Healthcare System in New Jersey.
2. New Antitrust Guidelines Consider Labor Market
The new guidelines notably focus on labor competition, said Jody Boudreault, JD, attorney and chair of the Antitrust Life Sciences and Healthcare Group at Baker Botts law firm in Washington, DC. Health professionals typically have more employment opportunities in an urban area, unless hindered by restrictive noncompete agreements, and fewer options in rural settings.
In the Lifespan merger that fell through, Ms. Boudreault said that the newly created hospital system would have employed two thirds of Rhode Island's full-time nurses, limiting opportunities for local employment elsewhere.
“Going forward, I would expect federal authorities to review not only the competitive impact of the hospitals merging but also the competitive impact of the physician, and especially nursing, workforce,” she said.
FTC Chair Lina M. Khan noted similar labor market concerns.
In a statement to Congress, she said that hospital consolidation reduces options for employees, who fear “being blacklisted from further hiring in a system that controls many of the hospitals in the area” and “makes workers afraid to file complaints, organize their workplace, or leave before the end of a contract.”
3. Mergers Can Drive Care Costs Higher
When hospital markets become less competitive, the cost of care often increases. In Indiana, inpatient prices rose 13% in hospitals that merged. Another study found that prices at monopoly hospitals are 12% higher than in markets with four or more rivals. Even cross-market mergers, when hospitals in different geographic locations combine, can drive prices higher.
Dr. Werner told this news organization that more significant price hikes of 20-30% aren’t unheard of, with reimbursements by some commercial insurance companies rising as much as 50%. “That’s the direct price that the insurers pay, but the burden of those higher prices ultimately falls on patients through higher premiums,” she said.
Still, the American Hospital Association (AHA) says that mergers and acquisitions can significantly lower annual operating expenses per admission and reduce inpatient readmission rates and mortality measures. In comments to the FTC, the AHA stated that mergers could provide a lifeline for rural and community hospitals struggling with shrinking payer reimbursement and rising labor and supply costs. The business arrangements also could ensure these communities maintain continuity of care.
“In the long run, it’s not clear that it is good for patients because we start to see decreased access to some types of service, like labor and delivery, which are services needed in rural markets,” she said.
4. Mergers to Watch in 2024
Ms. Boudreault, who represented RWJBarnabas in the abandoned Saint Peter’s transaction, says the courts widely accepted the old merger guidelines, and it will take time to see how the new measures are interpreted. “The guidelines don’t yet have the force of law, but they can be persuasive to a court.”
Looking ahead, she is watching how Steward Health Care navigates its impending financial collapse. The nation’s largest private for-profit health system was previously owned by private equity firm Cerberus Capital Management and includes nine Massachusetts hospitals plus entities in at least seven other states.
Ms. Boudreault also plans to monitor Jefferson Health’s intent to merge with Lehigh Valley Health Network. “It’s a pretty big deal because they would become a 30-hospital system,” said Ms. Boudreault. The newly formed network would become the largest employer in Philadelphia.
5. Merger and Acquisition Reversals Unlikely
Dr. Werner said that mergers and acquisitions are complicated business moves that are nearly impossible to undo once approved, so it makes sense for agencies to continue to evaluate them closely.
“The costs of healthcare are borne by us as a society,” she said. “We’re going to have to live with the ill effects of a consolidated market once we let hospitals merge, so they deserve additional scrutiny.”
A version of this article appeared on Medscape.com.
Hospital mergers and acquisitions continue to garner intense scrutiny from lawmakers, with pressure likely to hold steady following the recent announcement of new antitrust guidelines and state and federal investigations into potential healthcare monopolies.
In December, the US Department of Justice (DOJ) and the Federal Trade Commission (FTC) released updated guidelines outlining the factors they consider when determining if a merger illegally monopolizes a local healthcare market or jeopardizes access to critical healthcare services.
While the impact of the latest guidelines is yet to be seen, concerns over healthcare market consolidation are not new. Over the past two decades, mergers have attracted attention for contributing to a decline in independent hospitals, said Rachel M. Werner, MD, PhD, executive director of the Leonard Davis Institute of Health Economics at the University of Pennsylvania, Philadelphia, Pennsylvania.
“At this point, most hospitals are operating in a pretty concentrated market,” she said.
Here are five things to know about the current state of hospital mergers.
1. Record-Breaking Merger Enforcements
The DOJ and FTC reported the highest level of enforcement activity in over 20 years in fiscal year 2022 — the latest available data. Together, the agencies filed 50 merger enforcement actions and brought a record-breaking number of merger enforcement challenges, resulting in 11 approved actions, the restructuring or abandonment of seven mergers, and six business deals entering litigation.
Included in those statistics was a proposed merger between the two largest health systems in Rhode Island, Lifespan and Care New England Health System, which was abandoned after the FTC and the state Attorney General took steps to block it. the HCA branch in Utah Healthcare abandoned plans for to acquire five Salt Lake City area hospitals from competitor Steward Health Care System, as did RWJBarnabas Health after exploring a merger with Saint Peter's Healthcare System in New Jersey.
2. New Antitrust Guidelines Consider Labor Market
The new guidelines notably focus on labor competition, said Jody Boudreault, JD, attorney and chair of the Antitrust Life Sciences and Healthcare Group at Baker Botts law firm in Washington, DC. Health professionals typically have more employment opportunities in an urban area, unless hindered by restrictive noncompete agreements, and fewer options in rural settings.
In the Lifespan merger that fell through, Ms. Boudreault said that the newly created hospital system would have employed two thirds of Rhode Island's full-time nurses, limiting opportunities for local employment elsewhere.
“Going forward, I would expect federal authorities to review not only the competitive impact of the hospitals merging but also the competitive impact of the physician, and especially nursing, workforce,” she said.
FTC Chair Lina M. Khan noted similar labor market concerns.
In a statement to Congress, she said that hospital consolidation reduces options for employees, who fear “being blacklisted from further hiring in a system that controls many of the hospitals in the area” and “makes workers afraid to file complaints, organize their workplace, or leave before the end of a contract.”
3. Mergers Can Drive Care Costs Higher
When hospital markets become less competitive, the cost of care often increases. In Indiana, inpatient prices rose 13% in hospitals that merged. Another study found that prices at monopoly hospitals are 12% higher than in markets with four or more rivals. Even cross-market mergers, when hospitals in different geographic locations combine, can drive prices higher.
Dr. Werner told this news organization that more significant price hikes of 20-30% aren’t unheard of, with reimbursements by some commercial insurance companies rising as much as 50%. “That’s the direct price that the insurers pay, but the burden of those higher prices ultimately falls on patients through higher premiums,” she said.
Still, the American Hospital Association (AHA) says that mergers and acquisitions can significantly lower annual operating expenses per admission and reduce inpatient readmission rates and mortality measures. In comments to the FTC, the AHA stated that mergers could provide a lifeline for rural and community hospitals struggling with shrinking payer reimbursement and rising labor and supply costs. The business arrangements also could ensure these communities maintain continuity of care.
“In the long run, it’s not clear that it is good for patients because we start to see decreased access to some types of service, like labor and delivery, which are services needed in rural markets,” she said.
4. Mergers to Watch in 2024
Ms. Boudreault, who represented RWJBarnabas in the abandoned Saint Peter’s transaction, says the courts widely accepted the old merger guidelines, and it will take time to see how the new measures are interpreted. “The guidelines don’t yet have the force of law, but they can be persuasive to a court.”
Looking ahead, she is watching how Steward Health Care navigates its impending financial collapse. The nation’s largest private for-profit health system was previously owned by private equity firm Cerberus Capital Management and includes nine Massachusetts hospitals plus entities in at least seven other states.
Ms. Boudreault also plans to monitor Jefferson Health’s intent to merge with Lehigh Valley Health Network. “It’s a pretty big deal because they would become a 30-hospital system,” said Ms. Boudreault. The newly formed network would become the largest employer in Philadelphia.
5. Merger and Acquisition Reversals Unlikely
Dr. Werner said that mergers and acquisitions are complicated business moves that are nearly impossible to undo once approved, so it makes sense for agencies to continue to evaluate them closely.
“The costs of healthcare are borne by us as a society,” she said. “We’re going to have to live with the ill effects of a consolidated market once we let hospitals merge, so they deserve additional scrutiny.”
A version of this article appeared on Medscape.com.
Asthma is not well controlled in about half of patients with the disease in the UK and Europe, increasing the risk of hospital admission and severe illness, and increasing healthcare costs.
Now, the authors of a new study have reported that poorly controlled asthma is also associated with a higher carbon footprint, eight times higher than that of well-controlled asthma and equivalent to the greenhouse gas emissions produced by more than 124,000 homes each year in the UK.
The study was published in the journal Thorax and is part of the Healthcare-Based Environmental Cost of Treatment (CARBON) programme, which aims to provide a broader understanding of the carbon footprint associated with respiratory care.
John Bell, BMBCh, medical director of BioPharmaceuticals Medical, AstraZeneca, and co-author of the study, said that he was surprised by the scale to which poorly controlled asthma contributed to the overall carbon footprint of asthma care. “This suggests that suboptimal asthma care is not just a public health issue, but also one which has environmental consequences,” he said.
Improving the care of asthma patients could help the NHS meet its net zero target, the authors suggested.
SABA – Largest Contributor to Asthma-Related Greenhouse Gases
To estimate the environmental footprint of asthma care in the UK, the researchers retrospectively analyzed anonymized data of 236,506 people with asthma submitted to the Clinical Practice Research Datalink between 2008 and 2019.
Greenhouse gas (GHG) emissions, measured as carbon dioxide equivalent (CO2e), were then estimated for asthma-related medication use, healthcare resource utilization, and severe exacerbations.
Well-controlled asthma was considered as having no episodes of severe worsening symptoms and fewer than three prescriptions of short-acting beta-agonists (SABAs) reliever inhalers in a year. Poorly controlled asthma included three or more SABA canister prescriptions or one or more episodes of severe worsening symptoms in a year.
Almost one in two patients with asthma (47.3%) were categorized as being poorly controlled.
The researchers estimated the overall carbon footprint attributed to asthma care when scaled to the entire UK asthma population was 750,540 tonnes CO2e/year, with poorly controlled asthma contributing to excess GHG emissions of 303,874 tonnes CO2e/year.
“Poorly controlled asthma generated three-fold higher greenhouse gas emissions per capita compared with well-controlled asthma, when taking into account GHG emissions related to all aspects of asthma care, including routine prescribing and management,” Dr. Bell explained. It also generated eight-fold higher excess per capita carbon footprint compared to well-controlled asthma.
SABA relievers represented the largest contributors to per capita asthma-related GHG emissions, accounting for more than 60% of overall GHG emissions and more than 90% of excess GHG emissions. The remainder was mostly due to healthcare resource utilization, such as GP and hospital visits, required to treat severe worsening symptoms.
The researchers acknowledged various limitations to their findings, including that the study results were largely descriptive in nature. And factors other than the level of asthma symptom control, such as prescribing patterns, may also have contributed to high SABA use.
Couple Optimized Patient Outcomes With Environmental Targets
With inappropriate SABA use having emerged as the single largest contributor to asthma care-related GHG emissions, improving this care could achieve substantial carbon emissions savings and help the NHS meet its net zero target, the authors explained.
This improvement could include the adoption of the Global Initiative for Asthma (GINA) treatment strategies that, since 2019, no longer recommends that SABAs are used alone as the preferred reliever for acute asthma symptoms, the authors wrote.
On the other hand, the Primary Care Respiratory Society (PCRS) highlights on its website that the Medicines and Healthcare Products Regulatory Agency (MHRA) had approved the use of a dual (inhaled corticosteroid/formoterol) combination treatment to be used as a reliever therapy for people aged 12 and over.
“In the UK, this new therapy option does not yet sit within an approved national guideline as NICE last updated its treatment pathway in 2020. We await a new national asthma guideline but do not anticipate this new joint approach between NICE, BTS [British Thoracic Society], and SIGN [Scottish Intercollegiate Guidelines Network] to publish until 2024,” the society wrote.
Dr. Bell explained that the carbon footprint of asthma care increased with higher socio-economic deprivation. “Thus, targeting suboptimal care to areas of higher deprivation could help improve patient outcomes and address health inequities, with the additional benefit of reducing the overall carbon footprint of asthma care,” he said.
This coupling of optimized patient outcomes with environmental targets to decrease GHG emissions could be extended to other chronic progressive diseases, particularly those associated with multi-morbidities, the authors wrote.
Dr. Andy Whittamore, MBBS, clinical lead at Asthma + Lung UK, who was not involved in the research, said: “This study highlights that high levels of uncontrolled asthma not only put thousands of people at risk of life-threatening asthma attacks, but also have a detrimental effect on the environment. It’s important to point out that people shouldn’t stop taking their inhalers because they are worried about the environment. The best thing for the environment is to keep your asthma under control,” he emphasized.
Please refer to the study for full study author disclosures.Dr. Hicks has disclosed no relevant financial relationships.
A version of this article appeared on Medscape UK.
Asthma is not well controlled in about half of patients with the disease in the UK and Europe, increasing the risk of hospital admission and severe illness, and increasing healthcare costs.
Now, the authors of a new study have reported that poorly controlled asthma is also associated with a higher carbon footprint, eight times higher than that of well-controlled asthma and equivalent to the greenhouse gas emissions produced by more than 124,000 homes each year in the UK.
The study was published in the journal Thorax and is part of the Healthcare-Based Environmental Cost of Treatment (CARBON) programme, which aims to provide a broader understanding of the carbon footprint associated with respiratory care.
John Bell, BMBCh, medical director of BioPharmaceuticals Medical, AstraZeneca, and co-author of the study, said that he was surprised by the scale to which poorly controlled asthma contributed to the overall carbon footprint of asthma care. “This suggests that suboptimal asthma care is not just a public health issue, but also one which has environmental consequences,” he said.
Improving the care of asthma patients could help the NHS meet its net zero target, the authors suggested.
SABA – Largest Contributor to Asthma-Related Greenhouse Gases
To estimate the environmental footprint of asthma care in the UK, the researchers retrospectively analyzed anonymized data of 236,506 people with asthma submitted to the Clinical Practice Research Datalink between 2008 and 2019.
Greenhouse gas (GHG) emissions, measured as carbon dioxide equivalent (CO2e), were then estimated for asthma-related medication use, healthcare resource utilization, and severe exacerbations.
Well-controlled asthma was considered as having no episodes of severe worsening symptoms and fewer than three prescriptions of short-acting beta-agonists (SABAs) reliever inhalers in a year. Poorly controlled asthma included three or more SABA canister prescriptions or one or more episodes of severe worsening symptoms in a year.
Almost one in two patients with asthma (47.3%) were categorized as being poorly controlled.
The researchers estimated the overall carbon footprint attributed to asthma care when scaled to the entire UK asthma population was 750,540 tonnes CO2e/year, with poorly controlled asthma contributing to excess GHG emissions of 303,874 tonnes CO2e/year.
“Poorly controlled asthma generated three-fold higher greenhouse gas emissions per capita compared with well-controlled asthma, when taking into account GHG emissions related to all aspects of asthma care, including routine prescribing and management,” Dr. Bell explained. It also generated eight-fold higher excess per capita carbon footprint compared to well-controlled asthma.
SABA relievers represented the largest contributors to per capita asthma-related GHG emissions, accounting for more than 60% of overall GHG emissions and more than 90% of excess GHG emissions. The remainder was mostly due to healthcare resource utilization, such as GP and hospital visits, required to treat severe worsening symptoms.
The researchers acknowledged various limitations to their findings, including that the study results were largely descriptive in nature. And factors other than the level of asthma symptom control, such as prescribing patterns, may also have contributed to high SABA use.
Couple Optimized Patient Outcomes With Environmental Targets
With inappropriate SABA use having emerged as the single largest contributor to asthma care-related GHG emissions, improving this care could achieve substantial carbon emissions savings and help the NHS meet its net zero target, the authors explained.
This improvement could include the adoption of the Global Initiative for Asthma (GINA) treatment strategies that, since 2019, no longer recommends that SABAs are used alone as the preferred reliever for acute asthma symptoms, the authors wrote.
On the other hand, the Primary Care Respiratory Society (PCRS) highlights on its website that the Medicines and Healthcare Products Regulatory Agency (MHRA) had approved the use of a dual (inhaled corticosteroid/formoterol) combination treatment to be used as a reliever therapy for people aged 12 and over.
“In the UK, this new therapy option does not yet sit within an approved national guideline as NICE last updated its treatment pathway in 2020. We await a new national asthma guideline but do not anticipate this new joint approach between NICE, BTS [British Thoracic Society], and SIGN [Scottish Intercollegiate Guidelines Network] to publish until 2024,” the society wrote.
Dr. Bell explained that the carbon footprint of asthma care increased with higher socio-economic deprivation. “Thus, targeting suboptimal care to areas of higher deprivation could help improve patient outcomes and address health inequities, with the additional benefit of reducing the overall carbon footprint of asthma care,” he said.
This coupling of optimized patient outcomes with environmental targets to decrease GHG emissions could be extended to other chronic progressive diseases, particularly those associated with multi-morbidities, the authors wrote.
Dr. Andy Whittamore, MBBS, clinical lead at Asthma + Lung UK, who was not involved in the research, said: “This study highlights that high levels of uncontrolled asthma not only put thousands of people at risk of life-threatening asthma attacks, but also have a detrimental effect on the environment. It’s important to point out that people shouldn’t stop taking their inhalers because they are worried about the environment. The best thing for the environment is to keep your asthma under control,” he emphasized.
Please refer to the study for full study author disclosures.Dr. Hicks has disclosed no relevant financial relationships.
A version of this article appeared on Medscape UK.
Asthma is not well controlled in about half of patients with the disease in the UK and Europe, increasing the risk of hospital admission and severe illness, and increasing healthcare costs.
Now, the authors of a new study have reported that poorly controlled asthma is also associated with a higher carbon footprint, eight times higher than that of well-controlled asthma and equivalent to the greenhouse gas emissions produced by more than 124,000 homes each year in the UK.
The study was published in the journal Thorax and is part of the Healthcare-Based Environmental Cost of Treatment (CARBON) programme, which aims to provide a broader understanding of the carbon footprint associated with respiratory care.
John Bell, BMBCh, medical director of BioPharmaceuticals Medical, AstraZeneca, and co-author of the study, said that he was surprised by the scale to which poorly controlled asthma contributed to the overall carbon footprint of asthma care. “This suggests that suboptimal asthma care is not just a public health issue, but also one which has environmental consequences,” he said.
Improving the care of asthma patients could help the NHS meet its net zero target, the authors suggested.
SABA – Largest Contributor to Asthma-Related Greenhouse Gases
To estimate the environmental footprint of asthma care in the UK, the researchers retrospectively analyzed anonymized data of 236,506 people with asthma submitted to the Clinical Practice Research Datalink between 2008 and 2019.
Greenhouse gas (GHG) emissions, measured as carbon dioxide equivalent (CO2e), were then estimated for asthma-related medication use, healthcare resource utilization, and severe exacerbations.
Well-controlled asthma was considered as having no episodes of severe worsening symptoms and fewer than three prescriptions of short-acting beta-agonists (SABAs) reliever inhalers in a year. Poorly controlled asthma included three or more SABA canister prescriptions or one or more episodes of severe worsening symptoms in a year.
Almost one in two patients with asthma (47.3%) were categorized as being poorly controlled.
The researchers estimated the overall carbon footprint attributed to asthma care when scaled to the entire UK asthma population was 750,540 tonnes CO2e/year, with poorly controlled asthma contributing to excess GHG emissions of 303,874 tonnes CO2e/year.
“Poorly controlled asthma generated three-fold higher greenhouse gas emissions per capita compared with well-controlled asthma, when taking into account GHG emissions related to all aspects of asthma care, including routine prescribing and management,” Dr. Bell explained. It also generated eight-fold higher excess per capita carbon footprint compared to well-controlled asthma.
SABA relievers represented the largest contributors to per capita asthma-related GHG emissions, accounting for more than 60% of overall GHG emissions and more than 90% of excess GHG emissions. The remainder was mostly due to healthcare resource utilization, such as GP and hospital visits, required to treat severe worsening symptoms.
The researchers acknowledged various limitations to their findings, including that the study results were largely descriptive in nature. And factors other than the level of asthma symptom control, such as prescribing patterns, may also have contributed to high SABA use.
Couple Optimized Patient Outcomes With Environmental Targets
With inappropriate SABA use having emerged as the single largest contributor to asthma care-related GHG emissions, improving this care could achieve substantial carbon emissions savings and help the NHS meet its net zero target, the authors explained.
This improvement could include the adoption of the Global Initiative for Asthma (GINA) treatment strategies that, since 2019, no longer recommends that SABAs are used alone as the preferred reliever for acute asthma symptoms, the authors wrote.
On the other hand, the Primary Care Respiratory Society (PCRS) highlights on its website that the Medicines and Healthcare Products Regulatory Agency (MHRA) had approved the use of a dual (inhaled corticosteroid/formoterol) combination treatment to be used as a reliever therapy for people aged 12 and over.
“In the UK, this new therapy option does not yet sit within an approved national guideline as NICE last updated its treatment pathway in 2020. We await a new national asthma guideline but do not anticipate this new joint approach between NICE, BTS [British Thoracic Society], and SIGN [Scottish Intercollegiate Guidelines Network] to publish until 2024,” the society wrote.
Dr. Bell explained that the carbon footprint of asthma care increased with higher socio-economic deprivation. “Thus, targeting suboptimal care to areas of higher deprivation could help improve patient outcomes and address health inequities, with the additional benefit of reducing the overall carbon footprint of asthma care,” he said.
This coupling of optimized patient outcomes with environmental targets to decrease GHG emissions could be extended to other chronic progressive diseases, particularly those associated with multi-morbidities, the authors wrote.
Dr. Andy Whittamore, MBBS, clinical lead at Asthma + Lung UK, who was not involved in the research, said: “This study highlights that high levels of uncontrolled asthma not only put thousands of people at risk of life-threatening asthma attacks, but also have a detrimental effect on the environment. It’s important to point out that people shouldn’t stop taking their inhalers because they are worried about the environment. The best thing for the environment is to keep your asthma under control,” he emphasized.
Please refer to the study for full study author disclosures.Dr. Hicks has disclosed no relevant financial relationships.
A version of this article appeared on Medscape UK.
Soot, or in scientific parlance “fine particulate matter,” isn’t just the stuff that blackens window sills or dulls car finishes — it’s a serious health hazard, linked to cardiopulmonary disease, asthma, allergies, and lung cancer, as well as a host of other harmful conditions.
Until recently, the annual ambient air quality standard established by the US Environmental Protection Agency (EPA) was a maximum of 12 micrograms per cubic meter of air of fine particles smaller than 2.5 microns (PM2.5).
But on February 7, 2024, the EPA announced that the Biden-Harris administration had finalized a new standard of 9 mcg PM2.5/per cubic meter of air.
In addition, the EPA reported that it will be modifying its PM2.5 monitoring network to include a factor that will account for the proximity to pollution sources of at-risk populations.
In a press release, the EPA said that the modification “will advance environmental justice by ensuring localized data collection in overburdened areas,” with the goal of informing future National Ambient Air Quality Standards reviews.
In a statement supporting the new standard, Environment America, a network of 30 state environmental groups, noted that in “the United States, the largest human-caused sources of soot pollution are fossil fuels — coal, oil, and gas — burned for electricity and transportation. Since the government last updated its standards, new research has found there may be no safe amount of air pollution and the World Health Organization cut in half its guidelines for allowable particulate matter (soot) pollution. The final rule lowers allowable soot limits for annual exposure by 25%, although it leaves the 24-hour limit unchanged, allowing for temporary pollution spikes.”
A Good Start
Pulmonologists interviewed for this article also applauded the tightened PM2.5 standard, but said that the change doesn’t go far enough.
“We know that particulate matter, also called particulate pollution, is the most dangerous form of air pollution, and there has been an extensive body of literature which outlines the negative impact of air pollution and poor air quality not only on respiratory health, but also on cardiovascular disease, premature pregnancies, mental health, and death,” Anne C. Coates, MD, FCCP, a pediatric pulmonologist at MaineHealth in Portland, Maine, said in an interview with this news organization.
“Lowering the limits certainly can help promote overall health as well as reduce asthma, COPD exacerbations, heart attacks, hospitalizations and death,” she said.
However “I wish that the EPA had gone further to address lowering the daily particulate matter standards because, remember, what they issued on February 7th was the reduction in the annual particulate matter,” she noted.
With the tighter standards, “things are going the right way,” said Priya Balakrishnan, MD, MS, FCCP, assistant professor in the Section of Pulmonary and Critical Care Medicine at West Virginia University in Morgantown.
Following Trump administration efforts to weaken regulatory authority and reverse environmental regulations promulgated under President Obama, “this is the first kind of positive legislation moving forward,” she said in an interview with this news organization.
“Obviously, it’s not ideal, because it’s just monitoring the annual particulate matter 2.5 levels rather than daily ones, but it’s still a change in the right direction,” she said.
Deadly Air
As Dr. Coates and Dr. Balakrishnan noted, the revised ambient air standard is averaged over a year, and as such may not accurately capture periods where particulate matter concentrations are dangerously high, as occurs in many US states and Canadian provinces during wildfire season, or when one of the more than 200 remaining coal-fired power plants in the US release clouds of soot during daily operations or especially during periods of high electricity demand.
Some pollution sources are worse than others, as shown by a study published in the November 24, 2023, issue of Science. Health and environmental investigators reported that among Medicare beneficiaries, exposure to PM2.5 from sulfur dioxide released by coal burning for electricity generation was associated with a doubling in risk of death compared to PM2.5 exposure from all other sources.
Air pollution has also been identified as a key factor in the development of non–small cell lung cancer in nonsmokers, according to Charles Swanton, PhD, of the Francis Crick Institute, and chief clinician of Cancer Research UK, both in London, and his colleagues.
As Dr. Swanton reported at the 2022 European Society for Medical Oncology Congress, among 447,932 participants in the UK Biobank, increasing exposure to PM2.5 was significantly associated with seven cancer types, including lung cancer. They also saw an association between PM2.5 exposure levels and EGFR-mutated lung cancer incidence in the United Kingdom, South Korea, and Taiwan.
And as the investigators showed in mouse models, exposure to PM2.5 of lung cells bearing somatic EGFR and KRAS mutations causes recruitment of macrophages that in turn secrete interleukin-1B, resulting in a transdifferentiation of EGFR-mutated cells into a cancer stem cell state, and tumor formation.
Monitoring At-Risk Communities
Lisa Frank, executive director of the Washington legislative office of Environment America, explained in an interview how the revised standards may result in improvements in air quality, especially for at-risk populations such as lower-income urban dwellers.
“Regulations on particulate matter have been around for a few decades now, so there’s an established process that the state agencies and the EPA go through to make sure that air quality standards are met,” she said.
Over the next several years, the EPA will designate areas of the United States as either being in “attainment” (meeting primary or secondary ambient air quality standards) or in “nonattainment.”
“After that, implementation is up to the state and local air boards. They all are required to have a certain number of air quality monitors to keep track of pollution and they also handle reviewing permits for new construction, highways or other projects in that county that might affect air pollution,” she said.
Depending upon their size, counties are required under federal law to have air-quality monitoring sites in areas that are likely to have the worst air quality, such as major highways or urban traffic corridors.
Under the revised regulations, counties will be expected to have air-quality monitoring stations in or near at-risk communities, which should help to mitigate inequities that arise from proximity of polluting power plants in less-advantaged locations, Ms. Frank said.
“I think obviously any improvement in air quality is going to benefit everyone who breathes there, which I hope is all of us, but certainly people who already have the most air pollution hopefully should see bigger gains as well,” she said.
All persons interviewed for this article reported no relevant conflicts of interest. Dr. Coates and Dr. Balakrishnan are members of the editorial advisory board for CHEST Physician.
Soot, or in scientific parlance “fine particulate matter,” isn’t just the stuff that blackens window sills or dulls car finishes — it’s a serious health hazard, linked to cardiopulmonary disease, asthma, allergies, and lung cancer, as well as a host of other harmful conditions.
Until recently, the annual ambient air quality standard established by the US Environmental Protection Agency (EPA) was a maximum of 12 micrograms per cubic meter of air of fine particles smaller than 2.5 microns (PM2.5).
But on February 7, 2024, the EPA announced that the Biden-Harris administration had finalized a new standard of 9 mcg PM2.5/per cubic meter of air.
In addition, the EPA reported that it will be modifying its PM2.5 monitoring network to include a factor that will account for the proximity to pollution sources of at-risk populations.
In a press release, the EPA said that the modification “will advance environmental justice by ensuring localized data collection in overburdened areas,” with the goal of informing future National Ambient Air Quality Standards reviews.
In a statement supporting the new standard, Environment America, a network of 30 state environmental groups, noted that in “the United States, the largest human-caused sources of soot pollution are fossil fuels — coal, oil, and gas — burned for electricity and transportation. Since the government last updated its standards, new research has found there may be no safe amount of air pollution and the World Health Organization cut in half its guidelines for allowable particulate matter (soot) pollution. The final rule lowers allowable soot limits for annual exposure by 25%, although it leaves the 24-hour limit unchanged, allowing for temporary pollution spikes.”
A Good Start
Pulmonologists interviewed for this article also applauded the tightened PM2.5 standard, but said that the change doesn’t go far enough.
“We know that particulate matter, also called particulate pollution, is the most dangerous form of air pollution, and there has been an extensive body of literature which outlines the negative impact of air pollution and poor air quality not only on respiratory health, but also on cardiovascular disease, premature pregnancies, mental health, and death,” Anne C. Coates, MD, FCCP, a pediatric pulmonologist at MaineHealth in Portland, Maine, said in an interview with this news organization.
“Lowering the limits certainly can help promote overall health as well as reduce asthma, COPD exacerbations, heart attacks, hospitalizations and death,” she said.
However “I wish that the EPA had gone further to address lowering the daily particulate matter standards because, remember, what they issued on February 7th was the reduction in the annual particulate matter,” she noted.
With the tighter standards, “things are going the right way,” said Priya Balakrishnan, MD, MS, FCCP, assistant professor in the Section of Pulmonary and Critical Care Medicine at West Virginia University in Morgantown.
Following Trump administration efforts to weaken regulatory authority and reverse environmental regulations promulgated under President Obama, “this is the first kind of positive legislation moving forward,” she said in an interview with this news organization.
“Obviously, it’s not ideal, because it’s just monitoring the annual particulate matter 2.5 levels rather than daily ones, but it’s still a change in the right direction,” she said.
Deadly Air
As Dr. Coates and Dr. Balakrishnan noted, the revised ambient air standard is averaged over a year, and as such may not accurately capture periods where particulate matter concentrations are dangerously high, as occurs in many US states and Canadian provinces during wildfire season, or when one of the more than 200 remaining coal-fired power plants in the US release clouds of soot during daily operations or especially during periods of high electricity demand.
Some pollution sources are worse than others, as shown by a study published in the November 24, 2023, issue of Science. Health and environmental investigators reported that among Medicare beneficiaries, exposure to PM2.5 from sulfur dioxide released by coal burning for electricity generation was associated with a doubling in risk of death compared to PM2.5 exposure from all other sources.
Air pollution has also been identified as a key factor in the development of non–small cell lung cancer in nonsmokers, according to Charles Swanton, PhD, of the Francis Crick Institute, and chief clinician of Cancer Research UK, both in London, and his colleagues.
As Dr. Swanton reported at the 2022 European Society for Medical Oncology Congress, among 447,932 participants in the UK Biobank, increasing exposure to PM2.5 was significantly associated with seven cancer types, including lung cancer. They also saw an association between PM2.5 exposure levels and EGFR-mutated lung cancer incidence in the United Kingdom, South Korea, and Taiwan.
And as the investigators showed in mouse models, exposure to PM2.5 of lung cells bearing somatic EGFR and KRAS mutations causes recruitment of macrophages that in turn secrete interleukin-1B, resulting in a transdifferentiation of EGFR-mutated cells into a cancer stem cell state, and tumor formation.
Monitoring At-Risk Communities
Lisa Frank, executive director of the Washington legislative office of Environment America, explained in an interview how the revised standards may result in improvements in air quality, especially for at-risk populations such as lower-income urban dwellers.
“Regulations on particulate matter have been around for a few decades now, so there’s an established process that the state agencies and the EPA go through to make sure that air quality standards are met,” she said.
Over the next several years, the EPA will designate areas of the United States as either being in “attainment” (meeting primary or secondary ambient air quality standards) or in “nonattainment.”
“After that, implementation is up to the state and local air boards. They all are required to have a certain number of air quality monitors to keep track of pollution and they also handle reviewing permits for new construction, highways or other projects in that county that might affect air pollution,” she said.
Depending upon their size, counties are required under federal law to have air-quality monitoring sites in areas that are likely to have the worst air quality, such as major highways or urban traffic corridors.
Under the revised regulations, counties will be expected to have air-quality monitoring stations in or near at-risk communities, which should help to mitigate inequities that arise from proximity of polluting power plants in less-advantaged locations, Ms. Frank said.
“I think obviously any improvement in air quality is going to benefit everyone who breathes there, which I hope is all of us, but certainly people who already have the most air pollution hopefully should see bigger gains as well,” she said.
All persons interviewed for this article reported no relevant conflicts of interest. Dr. Coates and Dr. Balakrishnan are members of the editorial advisory board for CHEST Physician.
Soot, or in scientific parlance “fine particulate matter,” isn’t just the stuff that blackens window sills or dulls car finishes — it’s a serious health hazard, linked to cardiopulmonary disease, asthma, allergies, and lung cancer, as well as a host of other harmful conditions.
Until recently, the annual ambient air quality standard established by the US Environmental Protection Agency (EPA) was a maximum of 12 micrograms per cubic meter of air of fine particles smaller than 2.5 microns (PM2.5).
But on February 7, 2024, the EPA announced that the Biden-Harris administration had finalized a new standard of 9 mcg PM2.5/per cubic meter of air.
In addition, the EPA reported that it will be modifying its PM2.5 monitoring network to include a factor that will account for the proximity to pollution sources of at-risk populations.
In a press release, the EPA said that the modification “will advance environmental justice by ensuring localized data collection in overburdened areas,” with the goal of informing future National Ambient Air Quality Standards reviews.
In a statement supporting the new standard, Environment America, a network of 30 state environmental groups, noted that in “the United States, the largest human-caused sources of soot pollution are fossil fuels — coal, oil, and gas — burned for electricity and transportation. Since the government last updated its standards, new research has found there may be no safe amount of air pollution and the World Health Organization cut in half its guidelines for allowable particulate matter (soot) pollution. The final rule lowers allowable soot limits for annual exposure by 25%, although it leaves the 24-hour limit unchanged, allowing for temporary pollution spikes.”
A Good Start
Pulmonologists interviewed for this article also applauded the tightened PM2.5 standard, but said that the change doesn’t go far enough.
“We know that particulate matter, also called particulate pollution, is the most dangerous form of air pollution, and there has been an extensive body of literature which outlines the negative impact of air pollution and poor air quality not only on respiratory health, but also on cardiovascular disease, premature pregnancies, mental health, and death,” Anne C. Coates, MD, FCCP, a pediatric pulmonologist at MaineHealth in Portland, Maine, said in an interview with this news organization.
“Lowering the limits certainly can help promote overall health as well as reduce asthma, COPD exacerbations, heart attacks, hospitalizations and death,” she said.
However “I wish that the EPA had gone further to address lowering the daily particulate matter standards because, remember, what they issued on February 7th was the reduction in the annual particulate matter,” she noted.
With the tighter standards, “things are going the right way,” said Priya Balakrishnan, MD, MS, FCCP, assistant professor in the Section of Pulmonary and Critical Care Medicine at West Virginia University in Morgantown.
Following Trump administration efforts to weaken regulatory authority and reverse environmental regulations promulgated under President Obama, “this is the first kind of positive legislation moving forward,” she said in an interview with this news organization.
“Obviously, it’s not ideal, because it’s just monitoring the annual particulate matter 2.5 levels rather than daily ones, but it’s still a change in the right direction,” she said.
Deadly Air
As Dr. Coates and Dr. Balakrishnan noted, the revised ambient air standard is averaged over a year, and as such may not accurately capture periods where particulate matter concentrations are dangerously high, as occurs in many US states and Canadian provinces during wildfire season, or when one of the more than 200 remaining coal-fired power plants in the US release clouds of soot during daily operations or especially during periods of high electricity demand.
Some pollution sources are worse than others, as shown by a study published in the November 24, 2023, issue of Science. Health and environmental investigators reported that among Medicare beneficiaries, exposure to PM2.5 from sulfur dioxide released by coal burning for electricity generation was associated with a doubling in risk of death compared to PM2.5 exposure from all other sources.
Air pollution has also been identified as a key factor in the development of non–small cell lung cancer in nonsmokers, according to Charles Swanton, PhD, of the Francis Crick Institute, and chief clinician of Cancer Research UK, both in London, and his colleagues.
As Dr. Swanton reported at the 2022 European Society for Medical Oncology Congress, among 447,932 participants in the UK Biobank, increasing exposure to PM2.5 was significantly associated with seven cancer types, including lung cancer. They also saw an association between PM2.5 exposure levels and EGFR-mutated lung cancer incidence in the United Kingdom, South Korea, and Taiwan.
And as the investigators showed in mouse models, exposure to PM2.5 of lung cells bearing somatic EGFR and KRAS mutations causes recruitment of macrophages that in turn secrete interleukin-1B, resulting in a transdifferentiation of EGFR-mutated cells into a cancer stem cell state, and tumor formation.
Monitoring At-Risk Communities
Lisa Frank, executive director of the Washington legislative office of Environment America, explained in an interview how the revised standards may result in improvements in air quality, especially for at-risk populations such as lower-income urban dwellers.
“Regulations on particulate matter have been around for a few decades now, so there’s an established process that the state agencies and the EPA go through to make sure that air quality standards are met,” she said.
Over the next several years, the EPA will designate areas of the United States as either being in “attainment” (meeting primary or secondary ambient air quality standards) or in “nonattainment.”
“After that, implementation is up to the state and local air boards. They all are required to have a certain number of air quality monitors to keep track of pollution and they also handle reviewing permits for new construction, highways or other projects in that county that might affect air pollution,” she said.
Depending upon their size, counties are required under federal law to have air-quality monitoring sites in areas that are likely to have the worst air quality, such as major highways or urban traffic corridors.
Under the revised regulations, counties will be expected to have air-quality monitoring stations in or near at-risk communities, which should help to mitigate inequities that arise from proximity of polluting power plants in less-advantaged locations, Ms. Frank said.
“I think obviously any improvement in air quality is going to benefit everyone who breathes there, which I hope is all of us, but certainly people who already have the most air pollution hopefully should see bigger gains as well,” she said.
All persons interviewed for this article reported no relevant conflicts of interest. Dr. Coates and Dr. Balakrishnan are members of the editorial advisory board for CHEST Physician.
Viral infections frequently cause acute respiratory failure requiring ICU admission. In the United States, influenza causes over 50,000 deaths annually and SARS-CoV2 resulted in 170,000 hospitalizations in December 2023 alone.1 2 RSV lacks precise incidence data due to inconsistent testing but is increasingly implicated in respiratory failure.
Patients with underlying pulmonary comorbidities are at increased risk of severe infection. RSV induces bronchospasm and increases the risk for severe infection in patients with obstructive lung disease.3 Additionally, COPD patients with viral respiratory infections have higher rates of ICU admission, mechanical ventilation, and death compared with similar patients admitted for other etiologies.4
Diagnosis typically is achieved with nasopharyngeal PCR swabs. Positive viral swabs correlate with higher ICU admission and ventilation rates in patients with COPD.4 Coinfection with multiple respiratory viruses leads to higher mortality rates and bacterial and fungal coinfection further increases morbidity and mortality.5
Treatment includes respiratory support with noninvasive ventilation and high-flow nasal cannula, reducing the need for mechanical ventilation.6 Inhaled bronchodilators are particularly beneficial in patients with RSV infection.5 Oseltamivir reduces mortality in severe influenza cases, while remdesivir shows efficacy in SARS-CoV2 infection not requiring invasive ventilation.7 Severe SARS-CoV2 infection can be treated with immunomodulators. However, their availability is limited. Corticosteroids reduce mortality and mechanical ventilation in patients with SARS-CoV2; however, their use is associated with worse outcomes in influenza and RSV.7 8
Vaccination remains crucial for prevention of severe disease. RSV vaccination, in addition to influenza and SARS-CoV2 immunization, presents an opportunity to reduce morbidity and mortality.
References
1. Troeger C, et al. Lancet Infect Dis. 2018;18[11]:1191-1210.
2. WHO COVID-19 Epidemiological Update, 2024.
3. Coussement J, et al. Chest. 2022;161[6]:1475-1484.
4. Mulpuru S, et al. Influenza Other Respir Viruses. 2022;16[6]:1172-1182.
5. Saura O, et al. Expert Rev Anti Infect Ther. 2022;20[12]:1537-1550.
6. Inglis R, Ayebale E, Schultz MJ. Curr Opin Crit Care. 2019;25[1]:45-53.
7. O’Driscoll LS, Martin-Loeches I. Semin Respir Crit Care Med. 2021;42[6]:771-787.
Viral infections frequently cause acute respiratory failure requiring ICU admission. In the United States, influenza causes over 50,000 deaths annually and SARS-CoV2 resulted in 170,000 hospitalizations in December 2023 alone.1 2 RSV lacks precise incidence data due to inconsistent testing but is increasingly implicated in respiratory failure.
Patients with underlying pulmonary comorbidities are at increased risk of severe infection. RSV induces bronchospasm and increases the risk for severe infection in patients with obstructive lung disease.3 Additionally, COPD patients with viral respiratory infections have higher rates of ICU admission, mechanical ventilation, and death compared with similar patients admitted for other etiologies.4
Diagnosis typically is achieved with nasopharyngeal PCR swabs. Positive viral swabs correlate with higher ICU admission and ventilation rates in patients with COPD.4 Coinfection with multiple respiratory viruses leads to higher mortality rates and bacterial and fungal coinfection further increases morbidity and mortality.5
Treatment includes respiratory support with noninvasive ventilation and high-flow nasal cannula, reducing the need for mechanical ventilation.6 Inhaled bronchodilators are particularly beneficial in patients with RSV infection.5 Oseltamivir reduces mortality in severe influenza cases, while remdesivir shows efficacy in SARS-CoV2 infection not requiring invasive ventilation.7 Severe SARS-CoV2 infection can be treated with immunomodulators. However, their availability is limited. Corticosteroids reduce mortality and mechanical ventilation in patients with SARS-CoV2; however, their use is associated with worse outcomes in influenza and RSV.7 8
Vaccination remains crucial for prevention of severe disease. RSV vaccination, in addition to influenza and SARS-CoV2 immunization, presents an opportunity to reduce morbidity and mortality.
References
1. Troeger C, et al. Lancet Infect Dis. 2018;18[11]:1191-1210.
2. WHO COVID-19 Epidemiological Update, 2024.
3. Coussement J, et al. Chest. 2022;161[6]:1475-1484.
4. Mulpuru S, et al. Influenza Other Respir Viruses. 2022;16[6]:1172-1182.
5. Saura O, et al. Expert Rev Anti Infect Ther. 2022;20[12]:1537-1550.
6. Inglis R, Ayebale E, Schultz MJ. Curr Opin Crit Care. 2019;25[1]:45-53.
7. O’Driscoll LS, Martin-Loeches I. Semin Respir Crit Care Med. 2021;42[6]:771-787.
8. Bhimraj, A et al. Clin Inf Dis. 2022.
Chest Infections and Disaster Response Network
Disaster Response and Global Health Section
Zein Kattih, MD
Kathryn Hughes, MD
Brian Tran, MD
Viral infections frequently cause acute respiratory failure requiring ICU admission. In the United States, influenza causes over 50,000 deaths annually and SARS-CoV2 resulted in 170,000 hospitalizations in December 2023 alone.1 2 RSV lacks precise incidence data due to inconsistent testing but is increasingly implicated in respiratory failure.
Patients with underlying pulmonary comorbidities are at increased risk of severe infection. RSV induces bronchospasm and increases the risk for severe infection in patients with obstructive lung disease.3 Additionally, COPD patients with viral respiratory infections have higher rates of ICU admission, mechanical ventilation, and death compared with similar patients admitted for other etiologies.4
Diagnosis typically is achieved with nasopharyngeal PCR swabs. Positive viral swabs correlate with higher ICU admission and ventilation rates in patients with COPD.4 Coinfection with multiple respiratory viruses leads to higher mortality rates and bacterial and fungal coinfection further increases morbidity and mortality.5
Treatment includes respiratory support with noninvasive ventilation and high-flow nasal cannula, reducing the need for mechanical ventilation.6 Inhaled bronchodilators are particularly beneficial in patients with RSV infection.5 Oseltamivir reduces mortality in severe influenza cases, while remdesivir shows efficacy in SARS-CoV2 infection not requiring invasive ventilation.7 Severe SARS-CoV2 infection can be treated with immunomodulators. However, their availability is limited. Corticosteroids reduce mortality and mechanical ventilation in patients with SARS-CoV2; however, their use is associated with worse outcomes in influenza and RSV.7 8
Vaccination remains crucial for prevention of severe disease. RSV vaccination, in addition to influenza and SARS-CoV2 immunization, presents an opportunity to reduce morbidity and mortality.
References
1. Troeger C, et al. Lancet Infect Dis. 2018;18[11]:1191-1210.
2. WHO COVID-19 Epidemiological Update, 2024.
3. Coussement J, et al. Chest. 2022;161[6]:1475-1484.
4. Mulpuru S, et al. Influenza Other Respir Viruses. 2022;16[6]:1172-1182.
5. Saura O, et al. Expert Rev Anti Infect Ther. 2022;20[12]:1537-1550.
6. Inglis R, Ayebale E, Schultz MJ. Curr Opin Crit Care. 2019;25[1]:45-53.
7. O’Driscoll LS, Martin-Loeches I. Semin Respir Crit Care Med. 2021;42[6]:771-787.
Remodeling of airways and destruction of parenchyma by immune and inflammatory mechanisms are the leading cause of lung function decline in patients with COPD. Type 2 inflammation has been recognized as an important phenotypic pathway in asthma. However, its role in COPD has been much less clear, which had been largely associated with innate immune response.1
Activation of Interleukin (IL)-25, IL-33, thymic stromal lymphopoietin (TSLP) produces type 2 cytokines IL-4, IL-5, and IL-13, either by binding to ILC2 or by direct Th2 cells resulting in elevated eosinophils in sputum, lungs, and blood, as well as fractional exhaled nitric oxide.2 The combined inflammation from this pathway underpins the pathological changes seen in airway mucosa, causing mucous hypersecretion and hyperresponsiveness.
Prior trials delineating the role of biologics, such as mepolizumab and benralizumab, showed variable results with possible benefit of add-on biologics on the annual COPD exacerbations among patients with eosinophilic phenotype of COPD.3
More recently, the BOREAS trial evaluated the role of dupilumab as an add-on therapy for patients with type 2 inflammation-driven COPD established using blood eosinophil count of at least 300/mL at initial screening.4 Dupilumab is a human monoclonal antibody that blocks combined IL-4 and IL-13 pathways with a broader effect on the type 2 inflammation. It included patients with moderate to severe exacerbations despite maximal triple inhaler therapy with blood eosinophilia. Patients with asthma were excluded. This 52-week trial showed reduction in annual moderate to severe COPD exacerbations, sustained lung function improvement as measured by prebronchodilator FEV1, and improvement in patient-reported respiratory symptoms.4 Evaluation of sustainability of these results with therapy step-down approaches should be explored.
Remodeling of airways and destruction of parenchyma by immune and inflammatory mechanisms are the leading cause of lung function decline in patients with COPD. Type 2 inflammation has been recognized as an important phenotypic pathway in asthma. However, its role in COPD has been much less clear, which had been largely associated with innate immune response.1
Activation of Interleukin (IL)-25, IL-33, thymic stromal lymphopoietin (TSLP) produces type 2 cytokines IL-4, IL-5, and IL-13, either by binding to ILC2 or by direct Th2 cells resulting in elevated eosinophils in sputum, lungs, and blood, as well as fractional exhaled nitric oxide.2 The combined inflammation from this pathway underpins the pathological changes seen in airway mucosa, causing mucous hypersecretion and hyperresponsiveness.
Prior trials delineating the role of biologics, such as mepolizumab and benralizumab, showed variable results with possible benefit of add-on biologics on the annual COPD exacerbations among patients with eosinophilic phenotype of COPD.3
More recently, the BOREAS trial evaluated the role of dupilumab as an add-on therapy for patients with type 2 inflammation-driven COPD established using blood eosinophil count of at least 300/mL at initial screening.4 Dupilumab is a human monoclonal antibody that blocks combined IL-4 and IL-13 pathways with a broader effect on the type 2 inflammation. It included patients with moderate to severe exacerbations despite maximal triple inhaler therapy with blood eosinophilia. Patients with asthma were excluded. This 52-week trial showed reduction in annual moderate to severe COPD exacerbations, sustained lung function improvement as measured by prebronchodilator FEV1, and improvement in patient-reported respiratory symptoms.4 Evaluation of sustainability of these results with therapy step-down approaches should be explored.
References
1. Scanlon & McKenzie, 2012.
2. Brusselle et al, 2013.
3. Pavord et al, 2017.
4. Bhatt et al, 2023.
Airways Disorders Network
Asthma and COPD Section
Maria Azhar, MD
Abdullah Alismail, PhD, RRT, FCCP
Raghav Gupta, MD, FCCP
Remodeling of airways and destruction of parenchyma by immune and inflammatory mechanisms are the leading cause of lung function decline in patients with COPD. Type 2 inflammation has been recognized as an important phenotypic pathway in asthma. However, its role in COPD has been much less clear, which had been largely associated with innate immune response.1
Activation of Interleukin (IL)-25, IL-33, thymic stromal lymphopoietin (TSLP) produces type 2 cytokines IL-4, IL-5, and IL-13, either by binding to ILC2 or by direct Th2 cells resulting in elevated eosinophils in sputum, lungs, and blood, as well as fractional exhaled nitric oxide.2 The combined inflammation from this pathway underpins the pathological changes seen in airway mucosa, causing mucous hypersecretion and hyperresponsiveness.
Prior trials delineating the role of biologics, such as mepolizumab and benralizumab, showed variable results with possible benefit of add-on biologics on the annual COPD exacerbations among patients with eosinophilic phenotype of COPD.3
More recently, the BOREAS trial evaluated the role of dupilumab as an add-on therapy for patients with type 2 inflammation-driven COPD established using blood eosinophil count of at least 300/mL at initial screening.4 Dupilumab is a human monoclonal antibody that blocks combined IL-4 and IL-13 pathways with a broader effect on the type 2 inflammation. It included patients with moderate to severe exacerbations despite maximal triple inhaler therapy with blood eosinophilia. Patients with asthma were excluded. This 52-week trial showed reduction in annual moderate to severe COPD exacerbations, sustained lung function improvement as measured by prebronchodilator FEV1, and improvement in patient-reported respiratory symptoms.4 Evaluation of sustainability of these results with therapy step-down approaches should be explored.
The US Food and Drug Administration (FDA) has granted new approvals for the use of amivantamab-vmjw (Rybrevant, Janssen Biotech Inc.) in certain patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Specifically, the FDA approved the first-line use of the agent in combination with carboplatin and pemetrexed in patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.
The FDA also granted traditional approval for use in these patients after their cancer has progressed on or following platinum-based chemotherapy. The original accelerated approval for this indication occurred in 2021. At that time, the FDA also approved Guardant360® CDx (Guardant Health, Inc.) as a companion diagnostic test for amivantamab-vmjw.
The first-line approval, which followed priority review, was based on the randomized, open-label PAPILLON trial, which revealed a statistically significant improvement in progression-free survival (PFS) among the 153 patients who received amivantamab-vmjw plus carboplatin and pemetrexed vs the 155 who received the chemotherapy combination alone. Median PFS was 11.4 months in the amivantamab-vmjw arm vs 6.7 months in the control arm (hazard ratio, 0.40).
Data for overall survival, a key secondary endpoint of the study, were immature at the time of the latest analysis, but “no trend toward a detriment was observed,” according to an FDA approval announcement.
Common adverse reactions, occurring in at least 20% of patients in the study, were rash, nail toxicity, stomatitis, infusion-related reaction, fatigue, edema, constipation, decreased appetite, nausea, diarrhea, and vomiting. Weight-based dosing guidance can be found in the full prescribing information.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has granted new approvals for the use of amivantamab-vmjw (Rybrevant, Janssen Biotech Inc.) in certain patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Specifically, the FDA approved the first-line use of the agent in combination with carboplatin and pemetrexed in patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.
The FDA also granted traditional approval for use in these patients after their cancer has progressed on or following platinum-based chemotherapy. The original accelerated approval for this indication occurred in 2021. At that time, the FDA also approved Guardant360® CDx (Guardant Health, Inc.) as a companion diagnostic test for amivantamab-vmjw.
The first-line approval, which followed priority review, was based on the randomized, open-label PAPILLON trial, which revealed a statistically significant improvement in progression-free survival (PFS) among the 153 patients who received amivantamab-vmjw plus carboplatin and pemetrexed vs the 155 who received the chemotherapy combination alone. Median PFS was 11.4 months in the amivantamab-vmjw arm vs 6.7 months in the control arm (hazard ratio, 0.40).
Data for overall survival, a key secondary endpoint of the study, were immature at the time of the latest analysis, but “no trend toward a detriment was observed,” according to an FDA approval announcement.
Common adverse reactions, occurring in at least 20% of patients in the study, were rash, nail toxicity, stomatitis, infusion-related reaction, fatigue, edema, constipation, decreased appetite, nausea, diarrhea, and vomiting. Weight-based dosing guidance can be found in the full prescribing information.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has granted new approvals for the use of amivantamab-vmjw (Rybrevant, Janssen Biotech Inc.) in certain patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Specifically, the FDA approved the first-line use of the agent in combination with carboplatin and pemetrexed in patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.
The FDA also granted traditional approval for use in these patients after their cancer has progressed on or following platinum-based chemotherapy. The original accelerated approval for this indication occurred in 2021. At that time, the FDA also approved Guardant360® CDx (Guardant Health, Inc.) as a companion diagnostic test for amivantamab-vmjw.
The first-line approval, which followed priority review, was based on the randomized, open-label PAPILLON trial, which revealed a statistically significant improvement in progression-free survival (PFS) among the 153 patients who received amivantamab-vmjw plus carboplatin and pemetrexed vs the 155 who received the chemotherapy combination alone. Median PFS was 11.4 months in the amivantamab-vmjw arm vs 6.7 months in the control arm (hazard ratio, 0.40).
Data for overall survival, a key secondary endpoint of the study, were immature at the time of the latest analysis, but “no trend toward a detriment was observed,” according to an FDA approval announcement.
Common adverse reactions, occurring in at least 20% of patients in the study, were rash, nail toxicity, stomatitis, infusion-related reaction, fatigue, edema, constipation, decreased appetite, nausea, diarrhea, and vomiting. Weight-based dosing guidance can be found in the full prescribing information.
A version of this article appeared on Medscape.com.
Learn about the LGBTQ+ at CHEST, Respiratory Care, and Women in Chest Medicine Interest Groups
The value of member community is highly prized at CHEST. In order to provide supportive and engaging spaces where members can convene, share resources, and learn from other members who share similar lived experiences and interests, we were proud to add Interest Groups to our member offerings in 2023.
The introduction of Interest Groups has proven to be an effective way to organically connect CHEST members with shared interests and passions. Membership in one of these groups allows for networking in a smaller setting, with the goals of supporting career development and enriching an individual’s professional path.
CHEST
Dr. Margaret Pisani
CHEST
Dr. Kevin O'Neil
CHEST
Dr. Mauricio Danckers To learn more about the three existing Interest Groups, we spoke with each group’s chair: Margaret Pisani, MD, FCCP, Chair of the Women in Chest Medicine Interest Group; Kevin O’Neil, MD, FCCP, Chair of the Respiratory Care Interest Group; and Mauricio Danckers, MD, FCCP, Chair of the LGBTQ+ at CHEST Interest Group.
1) Tell us about the key issues that your Interest Group is trying to address and who should join this group.
Mauricio Danckers: Our LGBTQ+ community continues to be the target of unrelenting discrimination. Current disparities toward sexual and gender-diverse individuals persistently hinder their personal and professional growth. There are several key issues currently affecting the LGBTQ+ community; among those are ongoing health care disparities, lack of education of our providers on LGBTQ+ health issues, underrepresentation of scientific research in the LGBTQ+ community, and scarce opportunities for mentorship and networking among LGBTQ+ health professionals. Our Interest Group seeks to provide a space to work together to overcome these shortcomings. Through the exchange of ideas, the opportunity for interprofessional collaborations, resource development and dissemination, scholar productivity, organic mentoring, and patient and provider advocacy, we seek to create change and better serve the LGBTQ+ identity in our CHEST community.
Anyone who is ready to make a change for the LGBTQ+ community, their care, and their well-being is encouraged to join. Self-identification as a member of the LGBTQ+ community is not a prerequisite for joining our group. We welcome individuals committed to advancing gender-affirming health, wellness, and education approaches to reduce health disparities.
Kevin O’Neil: The Respiratory Care Interest Group is invested in a number of focus areas, including improving collaboration between pulmonary/critical care/sleep physicians and respiratory care providers with a goal of improved and more efficient patient care, addressing critical shortages in the respiratory therapist (RT) workforce in collaboration with respiratory care organizations by identifying and supporting strategies to grow the workforce, and promoting wellness in all members of the community by providing tools and resources to mitigate stress and reduce burnout.
This Interest Group is for any CHEST member with an interest in respiratory care education or care delivery.
Margaret Pisani: The Women in Chest Medicine Interest Group has two overarching goals. The first is focused on ensuring that content around sex as a biologic variable and the impact of gender—as they relate to lung disease and critical care—are addressed in the educational activities of CHEST. The second is to provide mentorship and aid with career advancement for women in pulmonary, critical care, and sleep medicine (PCCSM) who are members of CHEST.
Anyone who does research on the impact of sex and gender as biologic variables—and the importance of these variables in lung disease—is welcome in this Interest Group. Persons who would like to be involved in mentoring the next generation of women and junior members who would like to learn more about how to be active at CHEST are also encouraged to join.
2) What motivated you to lead an Interest Group?
Danckers: My path in medicine as an LGBTQ+ individual has been unique and personal. It has opened the opportunity to witness the urgency of the changes needed to serve our LGBTQ+ community better. I wanted to lead this Interest Group to connect to other members interested in advancing health care equity for LGBTQ+ individuals, to inspire one another to achieve major changes in LGBTQ+ health education, and to ignite an educational and social initiative supported by CHEST to witness the LGBTQ+ medical community thriving while grounded on mentoring and advocacy.
O’Neil: I’ve been a CHEST member for more than 35 years and involved with respiratory care almost as long. The relationship between pulmonary/critical care physicians and RTs is unique, and RTs are critically important to my ability to care for my patients. I am committed to facilitating opportunities for collaboration between the two groups.
Pisani: I am motivated by my passion to ensure we are providing the best possible education to our members and patients and supporting the next generation of leaders in the PCCSM community.
3) What are the goals for your Interest Group in 2024?
Danckers: 2024 will be an exciting year, no doubt about it! Our goals for 2024 are: 1) to connect talented individuals with professional goals that align with the ones from the Interest Group and CHEST, 2) to increase the presence of the LGBTQ+ identity representation in our CHEST scientific meetings and educational offerings, 3) to build a resource platform for LGBTQ+ health education with the innovative approach CHEST is known to provide, and 4) to provide venues to inspire and support scholarly work within the LGBTQ+ community.
O’Neil: Growing the Interest Group membership and increasing opportunities for RTs to participate in CHEST activities by providing a landing space for new RT members are key initiatives for us. We are also hoping to increase the visibility of the Interest Group through events at the annual meeting, educational offerings, and other opportunities as they arise. We will also focus on improving communication between CHEST and other respiratory organizations.
Pisani: We are focused on ensuring that sex and gender topics are addressed during scientific presentations when relevant to research and patient care and developing resources on specific topics where there is data regarding the impact of sex and gender in lung disease.
Learn about the LGBTQ+ at CHEST, Respiratory Care, and Women in Chest Medicine Interest Groups
Learn about the LGBTQ+ at CHEST, Respiratory Care, and Women in Chest Medicine Interest Groups
The value of member community is highly prized at CHEST. In order to provide supportive and engaging spaces where members can convene, share resources, and learn from other members who share similar lived experiences and interests, we were proud to add Interest Groups to our member offerings in 2023.
The introduction of Interest Groups has proven to be an effective way to organically connect CHEST members with shared interests and passions. Membership in one of these groups allows for networking in a smaller setting, with the goals of supporting career development and enriching an individual’s professional path.
CHEST
Dr. Margaret Pisani
CHEST
Dr. Kevin O'Neil
CHEST
Dr. Mauricio Danckers To learn more about the three existing Interest Groups, we spoke with each group’s chair: Margaret Pisani, MD, FCCP, Chair of the Women in Chest Medicine Interest Group; Kevin O’Neil, MD, FCCP, Chair of the Respiratory Care Interest Group; and Mauricio Danckers, MD, FCCP, Chair of the LGBTQ+ at CHEST Interest Group.
1) Tell us about the key issues that your Interest Group is trying to address and who should join this group.
Mauricio Danckers: Our LGBTQ+ community continues to be the target of unrelenting discrimination. Current disparities toward sexual and gender-diverse individuals persistently hinder their personal and professional growth. There are several key issues currently affecting the LGBTQ+ community; among those are ongoing health care disparities, lack of education of our providers on LGBTQ+ health issues, underrepresentation of scientific research in the LGBTQ+ community, and scarce opportunities for mentorship and networking among LGBTQ+ health professionals. Our Interest Group seeks to provide a space to work together to overcome these shortcomings. Through the exchange of ideas, the opportunity for interprofessional collaborations, resource development and dissemination, scholar productivity, organic mentoring, and patient and provider advocacy, we seek to create change and better serve the LGBTQ+ identity in our CHEST community.
Anyone who is ready to make a change for the LGBTQ+ community, their care, and their well-being is encouraged to join. Self-identification as a member of the LGBTQ+ community is not a prerequisite for joining our group. We welcome individuals committed to advancing gender-affirming health, wellness, and education approaches to reduce health disparities.
Kevin O’Neil: The Respiratory Care Interest Group is invested in a number of focus areas, including improving collaboration between pulmonary/critical care/sleep physicians and respiratory care providers with a goal of improved and more efficient patient care, addressing critical shortages in the respiratory therapist (RT) workforce in collaboration with respiratory care organizations by identifying and supporting strategies to grow the workforce, and promoting wellness in all members of the community by providing tools and resources to mitigate stress and reduce burnout.
This Interest Group is for any CHEST member with an interest in respiratory care education or care delivery.
Margaret Pisani: The Women in Chest Medicine Interest Group has two overarching goals. The first is focused on ensuring that content around sex as a biologic variable and the impact of gender—as they relate to lung disease and critical care—are addressed in the educational activities of CHEST. The second is to provide mentorship and aid with career advancement for women in pulmonary, critical care, and sleep medicine (PCCSM) who are members of CHEST.
Anyone who does research on the impact of sex and gender as biologic variables—and the importance of these variables in lung disease—is welcome in this Interest Group. Persons who would like to be involved in mentoring the next generation of women and junior members who would like to learn more about how to be active at CHEST are also encouraged to join.
2) What motivated you to lead an Interest Group?
Danckers: My path in medicine as an LGBTQ+ individual has been unique and personal. It has opened the opportunity to witness the urgency of the changes needed to serve our LGBTQ+ community better. I wanted to lead this Interest Group to connect to other members interested in advancing health care equity for LGBTQ+ individuals, to inspire one another to achieve major changes in LGBTQ+ health education, and to ignite an educational and social initiative supported by CHEST to witness the LGBTQ+ medical community thriving while grounded on mentoring and advocacy.
O’Neil: I’ve been a CHEST member for more than 35 years and involved with respiratory care almost as long. The relationship between pulmonary/critical care physicians and RTs is unique, and RTs are critically important to my ability to care for my patients. I am committed to facilitating opportunities for collaboration between the two groups.
Pisani: I am motivated by my passion to ensure we are providing the best possible education to our members and patients and supporting the next generation of leaders in the PCCSM community.
3) What are the goals for your Interest Group in 2024?
Danckers: 2024 will be an exciting year, no doubt about it! Our goals for 2024 are: 1) to connect talented individuals with professional goals that align with the ones from the Interest Group and CHEST, 2) to increase the presence of the LGBTQ+ identity representation in our CHEST scientific meetings and educational offerings, 3) to build a resource platform for LGBTQ+ health education with the innovative approach CHEST is known to provide, and 4) to provide venues to inspire and support scholarly work within the LGBTQ+ community.
O’Neil: Growing the Interest Group membership and increasing opportunities for RTs to participate in CHEST activities by providing a landing space for new RT members are key initiatives for us. We are also hoping to increase the visibility of the Interest Group through events at the annual meeting, educational offerings, and other opportunities as they arise. We will also focus on improving communication between CHEST and other respiratory organizations.
Pisani: We are focused on ensuring that sex and gender topics are addressed during scientific presentations when relevant to research and patient care and developing resources on specific topics where there is data regarding the impact of sex and gender in lung disease.
The value of member community is highly prized at CHEST. In order to provide supportive and engaging spaces where members can convene, share resources, and learn from other members who share similar lived experiences and interests, we were proud to add Interest Groups to our member offerings in 2023.
The introduction of Interest Groups has proven to be an effective way to organically connect CHEST members with shared interests and passions. Membership in one of these groups allows for networking in a smaller setting, with the goals of supporting career development and enriching an individual’s professional path.
CHEST
Dr. Margaret Pisani
CHEST
Dr. Kevin O'Neil
CHEST
Dr. Mauricio Danckers To learn more about the three existing Interest Groups, we spoke with each group’s chair: Margaret Pisani, MD, FCCP, Chair of the Women in Chest Medicine Interest Group; Kevin O’Neil, MD, FCCP, Chair of the Respiratory Care Interest Group; and Mauricio Danckers, MD, FCCP, Chair of the LGBTQ+ at CHEST Interest Group.
1) Tell us about the key issues that your Interest Group is trying to address and who should join this group.
Mauricio Danckers: Our LGBTQ+ community continues to be the target of unrelenting discrimination. Current disparities toward sexual and gender-diverse individuals persistently hinder their personal and professional growth. There are several key issues currently affecting the LGBTQ+ community; among those are ongoing health care disparities, lack of education of our providers on LGBTQ+ health issues, underrepresentation of scientific research in the LGBTQ+ community, and scarce opportunities for mentorship and networking among LGBTQ+ health professionals. Our Interest Group seeks to provide a space to work together to overcome these shortcomings. Through the exchange of ideas, the opportunity for interprofessional collaborations, resource development and dissemination, scholar productivity, organic mentoring, and patient and provider advocacy, we seek to create change and better serve the LGBTQ+ identity in our CHEST community.
Anyone who is ready to make a change for the LGBTQ+ community, their care, and their well-being is encouraged to join. Self-identification as a member of the LGBTQ+ community is not a prerequisite for joining our group. We welcome individuals committed to advancing gender-affirming health, wellness, and education approaches to reduce health disparities.
Kevin O’Neil: The Respiratory Care Interest Group is invested in a number of focus areas, including improving collaboration between pulmonary/critical care/sleep physicians and respiratory care providers with a goal of improved and more efficient patient care, addressing critical shortages in the respiratory therapist (RT) workforce in collaboration with respiratory care organizations by identifying and supporting strategies to grow the workforce, and promoting wellness in all members of the community by providing tools and resources to mitigate stress and reduce burnout.
This Interest Group is for any CHEST member with an interest in respiratory care education or care delivery.
Margaret Pisani: The Women in Chest Medicine Interest Group has two overarching goals. The first is focused on ensuring that content around sex as a biologic variable and the impact of gender—as they relate to lung disease and critical care—are addressed in the educational activities of CHEST. The second is to provide mentorship and aid with career advancement for women in pulmonary, critical care, and sleep medicine (PCCSM) who are members of CHEST.
Anyone who does research on the impact of sex and gender as biologic variables—and the importance of these variables in lung disease—is welcome in this Interest Group. Persons who would like to be involved in mentoring the next generation of women and junior members who would like to learn more about how to be active at CHEST are also encouraged to join.
2) What motivated you to lead an Interest Group?
Danckers: My path in medicine as an LGBTQ+ individual has been unique and personal. It has opened the opportunity to witness the urgency of the changes needed to serve our LGBTQ+ community better. I wanted to lead this Interest Group to connect to other members interested in advancing health care equity for LGBTQ+ individuals, to inspire one another to achieve major changes in LGBTQ+ health education, and to ignite an educational and social initiative supported by CHEST to witness the LGBTQ+ medical community thriving while grounded on mentoring and advocacy.
O’Neil: I’ve been a CHEST member for more than 35 years and involved with respiratory care almost as long. The relationship between pulmonary/critical care physicians and RTs is unique, and RTs are critically important to my ability to care for my patients. I am committed to facilitating opportunities for collaboration between the two groups.
Pisani: I am motivated by my passion to ensure we are providing the best possible education to our members and patients and supporting the next generation of leaders in the PCCSM community.
3) What are the goals for your Interest Group in 2024?
Danckers: 2024 will be an exciting year, no doubt about it! Our goals for 2024 are: 1) to connect talented individuals with professional goals that align with the ones from the Interest Group and CHEST, 2) to increase the presence of the LGBTQ+ identity representation in our CHEST scientific meetings and educational offerings, 3) to build a resource platform for LGBTQ+ health education with the innovative approach CHEST is known to provide, and 4) to provide venues to inspire and support scholarly work within the LGBTQ+ community.
O’Neil: Growing the Interest Group membership and increasing opportunities for RTs to participate in CHEST activities by providing a landing space for new RT members are key initiatives for us. We are also hoping to increase the visibility of the Interest Group through events at the annual meeting, educational offerings, and other opportunities as they arise. We will also focus on improving communication between CHEST and other respiratory organizations.
Pisani: We are focused on ensuring that sex and gender topics are addressed during scientific presentations when relevant to research and patient care and developing resources on specific topics where there is data regarding the impact of sex and gender in lung disease.
As the President of the American College of Chest Physicians (CHEST), I have the privilege of regularly addressing CHEST members through a quarterly column where I can share updates and expand on topics that we hold in high regard.
Dr. Jack D. Buckley
As such, I’d like to focus on the CHEST commitment to social responsibility and the work we have done and will continue to do throughout this year and beyond.
In 2023, under the leadership of my predecessor, Doreen Addrizzo-Harris, MD, FCCP, CHEST made strong changes to our organizational focus, including cementing Social Responsibility as a formal pillar of CHEST. In addition to our other four pillars—Education, People, Products, and Growth—this new pillar is a sign of our stronger commitment to be more explicit in our aspirations, measure our success, and move the bar higher.
As part of the new social responsibility pillar, CHEST philanthropy evolved from what was known as the CHEST Foundation and defined a new giving strategy that reflects our organizational commitment to clinical research, community impact, support for the profession, and fostering education. Through growth in our research support and furthering community impact, 2024 will be a strong year of providing grant support aligned to this new giving strategy.
In addition, we formalized how CHEST will pursue our new social responsibility pillar. In 2023, we articulated our organizational values—Community, Inclusivity, Innovation, Advocacy, and Integrity—which will serve as a consistent reminder of who we are as an organization and guide us in decisions as we pursue our mission.
Led by these values, CHEST will use its voice and capabilities to promote change that equitably impacts our community. In 2024 specifically, the organization looks forward to engaging actively with social responsibility by expanding volunteer opportunities local to CHEST headquarters and in conjunction with the location of the annual meeting.
It is also my hope that 2024 will be known as a year of member input, starring feedback from none other than you, our members.
For those who recall my address from the Opening Session at CHEST 2023, I very much encourage you to reach out to share with me your thoughts, your CHEST experience, and more at [email protected]. I look forward to having this regular touchpoint with all of you, and I welcome your input on topics you’d like to hear more on.
As the President of the American College of Chest Physicians (CHEST), I have the privilege of regularly addressing CHEST members through a quarterly column where I can share updates and expand on topics that we hold in high regard.
Dr. Jack D. Buckley
As such, I’d like to focus on the CHEST commitment to social responsibility and the work we have done and will continue to do throughout this year and beyond.
In 2023, under the leadership of my predecessor, Doreen Addrizzo-Harris, MD, FCCP, CHEST made strong changes to our organizational focus, including cementing Social Responsibility as a formal pillar of CHEST. In addition to our other four pillars—Education, People, Products, and Growth—this new pillar is a sign of our stronger commitment to be more explicit in our aspirations, measure our success, and move the bar higher.
As part of the new social responsibility pillar, CHEST philanthropy evolved from what was known as the CHEST Foundation and defined a new giving strategy that reflects our organizational commitment to clinical research, community impact, support for the profession, and fostering education. Through growth in our research support and furthering community impact, 2024 will be a strong year of providing grant support aligned to this new giving strategy.
In addition, we formalized how CHEST will pursue our new social responsibility pillar. In 2023, we articulated our organizational values—Community, Inclusivity, Innovation, Advocacy, and Integrity—which will serve as a consistent reminder of who we are as an organization and guide us in decisions as we pursue our mission.
Led by these values, CHEST will use its voice and capabilities to promote change that equitably impacts our community. In 2024 specifically, the organization looks forward to engaging actively with social responsibility by expanding volunteer opportunities local to CHEST headquarters and in conjunction with the location of the annual meeting.
It is also my hope that 2024 will be known as a year of member input, starring feedback from none other than you, our members.
For those who recall my address from the Opening Session at CHEST 2023, I very much encourage you to reach out to share with me your thoughts, your CHEST experience, and more at [email protected]. I look forward to having this regular touchpoint with all of you, and I welcome your input on topics you’d like to hear more on.
Until next time,
Jack D. Buckley, MD, MPH, FCCP
As the President of the American College of Chest Physicians (CHEST), I have the privilege of regularly addressing CHEST members through a quarterly column where I can share updates and expand on topics that we hold in high regard.
Dr. Jack D. Buckley
As such, I’d like to focus on the CHEST commitment to social responsibility and the work we have done and will continue to do throughout this year and beyond.
In 2023, under the leadership of my predecessor, Doreen Addrizzo-Harris, MD, FCCP, CHEST made strong changes to our organizational focus, including cementing Social Responsibility as a formal pillar of CHEST. In addition to our other four pillars—Education, People, Products, and Growth—this new pillar is a sign of our stronger commitment to be more explicit in our aspirations, measure our success, and move the bar higher.
As part of the new social responsibility pillar, CHEST philanthropy evolved from what was known as the CHEST Foundation and defined a new giving strategy that reflects our organizational commitment to clinical research, community impact, support for the profession, and fostering education. Through growth in our research support and furthering community impact, 2024 will be a strong year of providing grant support aligned to this new giving strategy.
In addition, we formalized how CHEST will pursue our new social responsibility pillar. In 2023, we articulated our organizational values—Community, Inclusivity, Innovation, Advocacy, and Integrity—which will serve as a consistent reminder of who we are as an organization and guide us in decisions as we pursue our mission.
Led by these values, CHEST will use its voice and capabilities to promote change that equitably impacts our community. In 2024 specifically, the organization looks forward to engaging actively with social responsibility by expanding volunteer opportunities local to CHEST headquarters and in conjunction with the location of the annual meeting.
It is also my hope that 2024 will be known as a year of member input, starring feedback from none other than you, our members.
For those who recall my address from the Opening Session at CHEST 2023, I very much encourage you to reach out to share with me your thoughts, your CHEST experience, and more at [email protected]. I look forward to having this regular touchpoint with all of you, and I welcome your input on topics you’d like to hear more on.
Bedside-focused cardiac ultrasound assessment, or cardiac point-of-care ultrasound (POCUS), has become common in intensive care units throughout the US and the world. Many clinicians argue a POCUS cardiac assessment should be completed in most hypotensive patients and all cases of undifferentiated shock.
However, obtaining images adequate for decision making via standard transthoracic echo (TTE) is not possible in a significant number of patients; as high as 30% of critically ill patients, according to The American Society of Echocardiography (ASE) guidelines.1 Factors common to critically ill patients, such as invasive mechanical ventilation, external dressings, and limited mobility, contribute to poor image acquisition.
CHEST
Dr. Kevin Proud
In almost all these cases, the factors limiting image acquisition can be eliminated by utilizing a transesophageal approach. In a recent study, researchers were able to demonstrate that adding transesophageal echocardiography (TEE) to TTE in critically ill patients yielded a new diagnosis or a change in management about 45% of the time.2
Using transesophageal ultrasound for a focused cardiac assessment in hemodynamically unstable patients is not new—and is often referred to as rescue TEE or resuscitative TEE. A broader term, transesophageal ultrasound, has also been used to include sonographic evaluation of the lungs in patients with poor acoustic windows. At my institution, we use the term critical care TEE to define TEE performed by a noncardiology-trained intensivist in an intubated critically ill patient.
Regardless of the term, the use of transesophageal ultrasound by the noncardiologist in the ICU appears to be a developing trend. As with other uses of POCUS, ultrasound machines continue to be able to “do more” at a lower price point. In 2024, several cart-based ultrasound machines are compatible with transesophageal probes and contain software packages capable of common cardiac measurements.
Despite this growing interest, intensivists are likely to encounter barriers to implementing critical care TEE. Our division recently implemented adding TEE to our practice. Our practice involves two separate systems: a Veterans Administration hospital and a university-based county hospital. Our division has integrated the use of TEE in the medical ICU at both institutions. Having navigated the process at both institutions, I can offer some guidance in navigating barriers.
The development of a critical care TEE program must start with a strong base in transthoracic cardiac POCUS, at least for the foreseeable future. Having a strong background in TTE gives learners a solid foundation in cardiac anatomy, cardiac function, and ultrasound properties. Obtaining testamur status or board certification in critical care echocardiography is not an absolute must but is a definite benefit. Having significant experience in TTE image acquisition and interpretation will flatten the learning curve for TEE. Interestingly, image acquisition in TEE is often easier than in TTE, so the paradigm of learning TTE before TEE may reverse in the years to come.
Two barriers often work together to create a vicious cycle that stops the development of a TEE program at its start. These barriers include the lack of training and lack of equipment, specifically a TEE probe. Those who do not understand the value of TEE may ask, “Why purchase equipment for a procedure that you do not yet know how to do?” The opposite question can also be asked, “Why get trained to do something you don’t have the equipment to perform?”
My best advice to break this cycle is to “dive in” to whichever barrier seems easier to overcome first. I started with obtaining knowledge and training. Obtaining training and education in a procedure that is historically not done in your specialty is challenging but is not impossible. It takes a combination of high levels of self-motivation and at least one colleague with the training to support you. I approached a cardiac anesthesiologist, whom I knew from the surgical ICU. Cardiologists can also be a resource, but working with cardiac anesthesiologists offers several advantages. TEEs done by cardiac anesthesiologists are similar to those done in ICU patients (ie, all patients are intubated and sedated). The procedures are also scheduled several days in advance, making it easier to integrate training into your daily work schedule. Lastly, the TEE probe remains in place for several hours, so repeating the probe manipulations again as a learner does not add additional risk to the patient. In my case, we somewhat arbitrarily agreed that I participate in 25 TEE exams. (CME courses, both online and in-person simulation, exist and greatly supplement self-study.)
Obtaining equipment is also a common barrier, though this has become less restrictive in the last several years. As previously mentioned, many cart-based ultrasound machines can accommodate a TEE probe. This changes the request from purchasing a new machine to “just a probe.” Despite the higher cost than most other probes, those in charge of purchasing are often more open to purchasing “a probe” than to purchasing an ultrasound machine.
Additionally, the purchasing decision regarding probes may fall to a different person than it does for an ultrasound machine. If available, POCUS image archiving into the medical record can help offset the cost of equipment, both by increasing revenue via billing and by demonstrating that equipment is being used. If initially declined, continue to ask and work to integrate the purchase into the next year’s budget. Inquire about the process of making a formal request and follow that process. This will often involve obtaining a quote or quotes from the ultrasound manufacturer(s).
Keep in mind that the probe will require a special storage cabinet specifically designed for TEE probes. It is prudent to include this in budget requests. If needed, the echocardiography lab can be a useful resource for additional information regarding the cabinet requirements. It is strongly recommended to discuss TEE probe models with sterile processing before any purchasing. If options are available, it is wise to choose a model the hospital already uses, as the cleaning protocol is well established. Our unit purchased a model that did not have an established protocol, which took nearly 6 months to develop. If probe options are limited, involving sterile processing early to start developing a protocol will help decrease delays.
Obtaining hospital privileges is also a common barrier, though this may not be as challenging as expected. Hospitals typically have well-outlined policies on obtaining privileges for established procedures. One of our hospital systems had four different options; the most straightforward required 20 hours of CME specific to TEE and 10 supervised cases by a proctor currently holding TEE privileges (see Table 1).
Discussions about obtaining privileges should involve your division chief, chair of medicine, and the cardiology division chief. Clearly outlining the plan to perform this procedure only in critically ill patients who are already intubated for other reasons made these conversations go much more smoothly. In the development of delineation of privileges, we used the term critical care TEE to clearly define this patient population. During these conversations, highlight the safety of the procedure; ASE guidelines3 estimate a severe complication rate of less than 1 in 10,000 cases and explain the anticipated benefits to critically ill patients.
In conclusion, at an institution that is already adept at the use of POCUS in the ICU, the additional of critical care TEE within 1 to 2 years is a very realistic achievement. It will undoubtedly require patience, persistence, and self-motivation, but the barriers are becoming smaller every day. Stay motivated!
Dr. Proud is Associate Professor of Medicine, Division of Pulmonary and Critical Care Medicine, Pulmonary and Critical Care Medicine Program Director, UT Health San Antonio.
References:
1. Porter TR, Abdelmoneim S, Belcik FT, et al. Guidelines for the cardiac sonographer in the performance of contrast echocardiography: a focused update from the American Society of Echocardiography. J Am Soc Echocardiogr. 2024;27(8):797-810.
2. Si X, Ma J, Cao DY, et al. Transesophageal echocardiography instead or in addition to transthoracic echocardiography in evaluating haemodynamic problems in intubated critically ill patients. Ann Transl Med. 2020;8(12):785.
3. Hahn RT, Abraham T, Adams MS, et al. Guidelines for performing a cmprehensive transesophageal echocardiographic examination: recommendations from the American Society of Echocardioraphy and the Society of Cardiovascular Anesthesiologists. J Am Soc Echocardiogr. 2013;26(9):921-964.
Bedside-focused cardiac ultrasound assessment, or cardiac point-of-care ultrasound (POCUS), has become common in intensive care units throughout the US and the world. Many clinicians argue a POCUS cardiac assessment should be completed in most hypotensive patients and all cases of undifferentiated shock.
However, obtaining images adequate for decision making via standard transthoracic echo (TTE) is not possible in a significant number of patients; as high as 30% of critically ill patients, according to The American Society of Echocardiography (ASE) guidelines.1 Factors common to critically ill patients, such as invasive mechanical ventilation, external dressings, and limited mobility, contribute to poor image acquisition.
CHEST
Dr. Kevin Proud
In almost all these cases, the factors limiting image acquisition can be eliminated by utilizing a transesophageal approach. In a recent study, researchers were able to demonstrate that adding transesophageal echocardiography (TEE) to TTE in critically ill patients yielded a new diagnosis or a change in management about 45% of the time.2
Using transesophageal ultrasound for a focused cardiac assessment in hemodynamically unstable patients is not new—and is often referred to as rescue TEE or resuscitative TEE. A broader term, transesophageal ultrasound, has also been used to include sonographic evaluation of the lungs in patients with poor acoustic windows. At my institution, we use the term critical care TEE to define TEE performed by a noncardiology-trained intensivist in an intubated critically ill patient.
Regardless of the term, the use of transesophageal ultrasound by the noncardiologist in the ICU appears to be a developing trend. As with other uses of POCUS, ultrasound machines continue to be able to “do more” at a lower price point. In 2024, several cart-based ultrasound machines are compatible with transesophageal probes and contain software packages capable of common cardiac measurements.
Despite this growing interest, intensivists are likely to encounter barriers to implementing critical care TEE. Our division recently implemented adding TEE to our practice. Our practice involves two separate systems: a Veterans Administration hospital and a university-based county hospital. Our division has integrated the use of TEE in the medical ICU at both institutions. Having navigated the process at both institutions, I can offer some guidance in navigating barriers.
The development of a critical care TEE program must start with a strong base in transthoracic cardiac POCUS, at least for the foreseeable future. Having a strong background in TTE gives learners a solid foundation in cardiac anatomy, cardiac function, and ultrasound properties. Obtaining testamur status or board certification in critical care echocardiography is not an absolute must but is a definite benefit. Having significant experience in TTE image acquisition and interpretation will flatten the learning curve for TEE. Interestingly, image acquisition in TEE is often easier than in TTE, so the paradigm of learning TTE before TEE may reverse in the years to come.
Two barriers often work together to create a vicious cycle that stops the development of a TEE program at its start. These barriers include the lack of training and lack of equipment, specifically a TEE probe. Those who do not understand the value of TEE may ask, “Why purchase equipment for a procedure that you do not yet know how to do?” The opposite question can also be asked, “Why get trained to do something you don’t have the equipment to perform?”
My best advice to break this cycle is to “dive in” to whichever barrier seems easier to overcome first. I started with obtaining knowledge and training. Obtaining training and education in a procedure that is historically not done in your specialty is challenging but is not impossible. It takes a combination of high levels of self-motivation and at least one colleague with the training to support you. I approached a cardiac anesthesiologist, whom I knew from the surgical ICU. Cardiologists can also be a resource, but working with cardiac anesthesiologists offers several advantages. TEEs done by cardiac anesthesiologists are similar to those done in ICU patients (ie, all patients are intubated and sedated). The procedures are also scheduled several days in advance, making it easier to integrate training into your daily work schedule. Lastly, the TEE probe remains in place for several hours, so repeating the probe manipulations again as a learner does not add additional risk to the patient. In my case, we somewhat arbitrarily agreed that I participate in 25 TEE exams. (CME courses, both online and in-person simulation, exist and greatly supplement self-study.)
Obtaining equipment is also a common barrier, though this has become less restrictive in the last several years. As previously mentioned, many cart-based ultrasound machines can accommodate a TEE probe. This changes the request from purchasing a new machine to “just a probe.” Despite the higher cost than most other probes, those in charge of purchasing are often more open to purchasing “a probe” than to purchasing an ultrasound machine.
Additionally, the purchasing decision regarding probes may fall to a different person than it does for an ultrasound machine. If available, POCUS image archiving into the medical record can help offset the cost of equipment, both by increasing revenue via billing and by demonstrating that equipment is being used. If initially declined, continue to ask and work to integrate the purchase into the next year’s budget. Inquire about the process of making a formal request and follow that process. This will often involve obtaining a quote or quotes from the ultrasound manufacturer(s).
Keep in mind that the probe will require a special storage cabinet specifically designed for TEE probes. It is prudent to include this in budget requests. If needed, the echocardiography lab can be a useful resource for additional information regarding the cabinet requirements. It is strongly recommended to discuss TEE probe models with sterile processing before any purchasing. If options are available, it is wise to choose a model the hospital already uses, as the cleaning protocol is well established. Our unit purchased a model that did not have an established protocol, which took nearly 6 months to develop. If probe options are limited, involving sterile processing early to start developing a protocol will help decrease delays.
Obtaining hospital privileges is also a common barrier, though this may not be as challenging as expected. Hospitals typically have well-outlined policies on obtaining privileges for established procedures. One of our hospital systems had four different options; the most straightforward required 20 hours of CME specific to TEE and 10 supervised cases by a proctor currently holding TEE privileges (see Table 1).
Discussions about obtaining privileges should involve your division chief, chair of medicine, and the cardiology division chief. Clearly outlining the plan to perform this procedure only in critically ill patients who are already intubated for other reasons made these conversations go much more smoothly. In the development of delineation of privileges, we used the term critical care TEE to clearly define this patient population. During these conversations, highlight the safety of the procedure; ASE guidelines3 estimate a severe complication rate of less than 1 in 10,000 cases and explain the anticipated benefits to critically ill patients.
In conclusion, at an institution that is already adept at the use of POCUS in the ICU, the additional of critical care TEE within 1 to 2 years is a very realistic achievement. It will undoubtedly require patience, persistence, and self-motivation, but the barriers are becoming smaller every day. Stay motivated!
Dr. Proud is Associate Professor of Medicine, Division of Pulmonary and Critical Care Medicine, Pulmonary and Critical Care Medicine Program Director, UT Health San Antonio.
References:
1. Porter TR, Abdelmoneim S, Belcik FT, et al. Guidelines for the cardiac sonographer in the performance of contrast echocardiography: a focused update from the American Society of Echocardiography. J Am Soc Echocardiogr. 2024;27(8):797-810.
2. Si X, Ma J, Cao DY, et al. Transesophageal echocardiography instead or in addition to transthoracic echocardiography in evaluating haemodynamic problems in intubated critically ill patients. Ann Transl Med. 2020;8(12):785.
3. Hahn RT, Abraham T, Adams MS, et al. Guidelines for performing a cmprehensive transesophageal echocardiographic examination: recommendations from the American Society of Echocardioraphy and the Society of Cardiovascular Anesthesiologists. J Am Soc Echocardiogr. 2013;26(9):921-964.
Bedside-focused cardiac ultrasound assessment, or cardiac point-of-care ultrasound (POCUS), has become common in intensive care units throughout the US and the world. Many clinicians argue a POCUS cardiac assessment should be completed in most hypotensive patients and all cases of undifferentiated shock.
However, obtaining images adequate for decision making via standard transthoracic echo (TTE) is not possible in a significant number of patients; as high as 30% of critically ill patients, according to The American Society of Echocardiography (ASE) guidelines.1 Factors common to critically ill patients, such as invasive mechanical ventilation, external dressings, and limited mobility, contribute to poor image acquisition.
CHEST
Dr. Kevin Proud
In almost all these cases, the factors limiting image acquisition can be eliminated by utilizing a transesophageal approach. In a recent study, researchers were able to demonstrate that adding transesophageal echocardiography (TEE) to TTE in critically ill patients yielded a new diagnosis or a change in management about 45% of the time.2
Using transesophageal ultrasound for a focused cardiac assessment in hemodynamically unstable patients is not new—and is often referred to as rescue TEE or resuscitative TEE. A broader term, transesophageal ultrasound, has also been used to include sonographic evaluation of the lungs in patients with poor acoustic windows. At my institution, we use the term critical care TEE to define TEE performed by a noncardiology-trained intensivist in an intubated critically ill patient.
Regardless of the term, the use of transesophageal ultrasound by the noncardiologist in the ICU appears to be a developing trend. As with other uses of POCUS, ultrasound machines continue to be able to “do more” at a lower price point. In 2024, several cart-based ultrasound machines are compatible with transesophageal probes and contain software packages capable of common cardiac measurements.
Despite this growing interest, intensivists are likely to encounter barriers to implementing critical care TEE. Our division recently implemented adding TEE to our practice. Our practice involves two separate systems: a Veterans Administration hospital and a university-based county hospital. Our division has integrated the use of TEE in the medical ICU at both institutions. Having navigated the process at both institutions, I can offer some guidance in navigating barriers.
The development of a critical care TEE program must start with a strong base in transthoracic cardiac POCUS, at least for the foreseeable future. Having a strong background in TTE gives learners a solid foundation in cardiac anatomy, cardiac function, and ultrasound properties. Obtaining testamur status or board certification in critical care echocardiography is not an absolute must but is a definite benefit. Having significant experience in TTE image acquisition and interpretation will flatten the learning curve for TEE. Interestingly, image acquisition in TEE is often easier than in TTE, so the paradigm of learning TTE before TEE may reverse in the years to come.
Two barriers often work together to create a vicious cycle that stops the development of a TEE program at its start. These barriers include the lack of training and lack of equipment, specifically a TEE probe. Those who do not understand the value of TEE may ask, “Why purchase equipment for a procedure that you do not yet know how to do?” The opposite question can also be asked, “Why get trained to do something you don’t have the equipment to perform?”
My best advice to break this cycle is to “dive in” to whichever barrier seems easier to overcome first. I started with obtaining knowledge and training. Obtaining training and education in a procedure that is historically not done in your specialty is challenging but is not impossible. It takes a combination of high levels of self-motivation and at least one colleague with the training to support you. I approached a cardiac anesthesiologist, whom I knew from the surgical ICU. Cardiologists can also be a resource, but working with cardiac anesthesiologists offers several advantages. TEEs done by cardiac anesthesiologists are similar to those done in ICU patients (ie, all patients are intubated and sedated). The procedures are also scheduled several days in advance, making it easier to integrate training into your daily work schedule. Lastly, the TEE probe remains in place for several hours, so repeating the probe manipulations again as a learner does not add additional risk to the patient. In my case, we somewhat arbitrarily agreed that I participate in 25 TEE exams. (CME courses, both online and in-person simulation, exist and greatly supplement self-study.)
Obtaining equipment is also a common barrier, though this has become less restrictive in the last several years. As previously mentioned, many cart-based ultrasound machines can accommodate a TEE probe. This changes the request from purchasing a new machine to “just a probe.” Despite the higher cost than most other probes, those in charge of purchasing are often more open to purchasing “a probe” than to purchasing an ultrasound machine.
Additionally, the purchasing decision regarding probes may fall to a different person than it does for an ultrasound machine. If available, POCUS image archiving into the medical record can help offset the cost of equipment, both by increasing revenue via billing and by demonstrating that equipment is being used. If initially declined, continue to ask and work to integrate the purchase into the next year’s budget. Inquire about the process of making a formal request and follow that process. This will often involve obtaining a quote or quotes from the ultrasound manufacturer(s).
Keep in mind that the probe will require a special storage cabinet specifically designed for TEE probes. It is prudent to include this in budget requests. If needed, the echocardiography lab can be a useful resource for additional information regarding the cabinet requirements. It is strongly recommended to discuss TEE probe models with sterile processing before any purchasing. If options are available, it is wise to choose a model the hospital already uses, as the cleaning protocol is well established. Our unit purchased a model that did not have an established protocol, which took nearly 6 months to develop. If probe options are limited, involving sterile processing early to start developing a protocol will help decrease delays.
Obtaining hospital privileges is also a common barrier, though this may not be as challenging as expected. Hospitals typically have well-outlined policies on obtaining privileges for established procedures. One of our hospital systems had four different options; the most straightforward required 20 hours of CME specific to TEE and 10 supervised cases by a proctor currently holding TEE privileges (see Table 1).
Discussions about obtaining privileges should involve your division chief, chair of medicine, and the cardiology division chief. Clearly outlining the plan to perform this procedure only in critically ill patients who are already intubated for other reasons made these conversations go much more smoothly. In the development of delineation of privileges, we used the term critical care TEE to clearly define this patient population. During these conversations, highlight the safety of the procedure; ASE guidelines3 estimate a severe complication rate of less than 1 in 10,000 cases and explain the anticipated benefits to critically ill patients.
In conclusion, at an institution that is already adept at the use of POCUS in the ICU, the additional of critical care TEE within 1 to 2 years is a very realistic achievement. It will undoubtedly require patience, persistence, and self-motivation, but the barriers are becoming smaller every day. Stay motivated!
Dr. Proud is Associate Professor of Medicine, Division of Pulmonary and Critical Care Medicine, Pulmonary and Critical Care Medicine Program Director, UT Health San Antonio.
References:
1. Porter TR, Abdelmoneim S, Belcik FT, et al. Guidelines for the cardiac sonographer in the performance of contrast echocardiography: a focused update from the American Society of Echocardiography. J Am Soc Echocardiogr. 2024;27(8):797-810.
2. Si X, Ma J, Cao DY, et al. Transesophageal echocardiography instead or in addition to transthoracic echocardiography in evaluating haemodynamic problems in intubated critically ill patients. Ann Transl Med. 2020;8(12):785.
3. Hahn RT, Abraham T, Adams MS, et al. Guidelines for performing a cmprehensive transesophageal echocardiographic examination: recommendations from the American Society of Echocardioraphy and the Society of Cardiovascular Anesthesiologists. J Am Soc Echocardiogr. 2013;26(9):921-964.
“Janice Turner” (name changed to protect confidentiality) is a 66-year-old woman with a 40-pack per year history of smoking. She quit smoking 1 year ago and presents to your office for a follow-up visit after discharge from the hospital 14 days ago. This was her second hospitalization for a COPD exacerbation in the past 12 months. She is very worried about having another COPD exacerbation and wants to know if there are additional medications she could try.
Over the past 2 weeks, her respiratory symptoms have improved and returned to her baseline. She has a daily cough with white phlegm on most days and dyspnea on exertion at one-half block on level ground. She reports using her medications as prescribed and is enrolled in a pulmonary rehabilitation program, which she attends twice per week. She uses 2 to 4 inhalations of albuterol each day.
CHEST
Dr. Jerry A. Krishnan
She is on the following regimen for her COPD, which is unchanged compared with what she has been prescribed for the past 12 months: 1) combination inhaled fluticasone furoate, umeclidinium, and vilanterol via the Ellipta® device, one actuation once daily and 2) inhaled albuterol, two puffs as needed every 4 hours via metered dose inhaler. She demonstrates mastery of inhaler technique for both inhaled devices. Her vaccinations are current (pneumococcus, influenza, respiratory syncytial virus, and COVID-19).
On examination, she can complete sentences without respiratory difficulty, and her vital signs are normal. She has decreased breath sounds in all lung fields, with occasional rhonchi. Heart sounds are distant, but regular, at 92 beats per minute, and she has no peripheral edema. Arterial blood gas at rest on room air indicates a pH of 7.38, PaO2 of 63 mm Hg, and PaCO2 of 42 mm Hg. An electrocardiogram shows sinus rhythm and a QTc interval of 420 milliseconds.
Three months ago, when she was clinically stable, you obtained spirometry, a complete blood count with differential, and a chest radiograph to exclude alternate diagnoses for her ongoing respiratory symptoms. She had severe airflow limitation (post-bronchodilator FEV1 = 40% predicted, FVC = 61% predicted, FEV1/FVC = 65%). At the time, she also had peripheral eosinophilia (eosinophil count of 350 cells/μL) and hyperinflation without parenchymal infiltrates.
CHEST
Dr. Muhammad Adrish
In summary, Ms. Turner has severe smoking-associated COPD Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 3E and chronic bronchitis with two severe exacerbations in the past 12 months.1 She is currently prescribed triple inhaled maintenance therapy with corticosteroids, long-acting β2-agonist, and long-acting muscarinic antagonist. She has a normal QTc interval.
So what would you recommend to reduce Ms. Turner’s risk of future exacerbations?
In 2011, the US Food and Drug Administration (FDA) approved roflumilast 500 mcg by mouth per day, a selective phosphodiesterase 4 (PDE4) inhibitor, as maintenance therapy to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis.2 The FDA approval was based on a review of the efficacy and safety of roflumilast in eight randomized, double-blind, controlled clinical trials in 9,394 adults with COPD.
Two subsequently completed randomized clinical trials in 2015 (REACT, 1,945 adults) and 2016 (RE2SPOND, 2,354 adults) also found that maintenance oral treatment escalation with roflumilast significantly reduced the risk of COPD exacerbations compared with placebo.2 The most common adverse effects reported with long-term use of roflumilast are related to the gastrointestinal tract (diarrhea, nausea, decreased appetite), weight loss, and insomnia. Four weeks of roflumilast at 250 mcg per day prior to dose escalation to 500 mcg per day reduces the risk of treatment discontinuation and improves tolerability compared with initiating treatment with the maintenance dose.
In 2022, the FDA approved a generic version of roflumilast, providing an opportunity for patients to use roflumilast at a lower cost than was previously possible. Importantly, the FDA Prescribing Information includes a warning to avoid the use of roflumilast in patients being treated with strong cytochrome P450 enzyme inducers (eg, rifampin, phenytoin). The FDA Prescribing Information also recommends weighing the risks and benefits of roflumilast in patients with a history of depression or suicidal thoughts or behavior, or patients with unexplained or clinically significant weight loss.
In 2011 (the same year as the FDA approval of roflumilast), the National Institutes of Health/National Heart, Lung, and Blood Institute-funded COPD Clinical Research Network reported that maintenance treatment with azithromycin reduced the risk of COPD exacerbations compared with placebo in a randomized clinical trial of 1,142 adults with COPD (MACRO study).3 Subgroup analyses indicated that the reduction in the risk of COPD exacerbations with azithromycin was observed in participants with or without chronic bronchitis but not in participants who currently smoked.
Subsequently, two other smaller randomized clinical trials in 2014 (COLUMBUS, 92 participants) and in 2019 (BACE, 301 participants) also demonstrated a reduction in the risk of COPD exacerbations with maintenance azithromycin treatment compared with placebo. Azithromycin can prolong the QT interval and, in rare cases, cause cardiac arrythmias, especially when used with other medications that can prolong the QT interval. There are also concerns that maintenance azithromycin therapy could lead to decrements in hearing or promote the development of macrolide-resistant bacteria. Maintenance treatment with azithromycin to prevent COPD exacerbations is not an FDA-approved indication.4 The FDA approval for azithromycin is currently limited to treatment of patients with mild to moderate infections caused by susceptible bacteria, but it is often prescribed off-label as maintenance treatment for COPD.
On the basis of this body of evidence from clinical trials in COPD, the 2015 CHEST and Canadian Thoracic Society (CTS) guidelines,5 the 2017 European Respiratory Society/American Thoracic Society (ERS/ATS) guidelines,6 and the 2024 GOLD Strategy Report all include recommendations for treatment escalation with maintenance roflumilast or azithromycin to reduce the risk of COPD exacerbations. For example, the 2024 GOLD Strategy Report recommends roflumilast in patients with severe COPD and chronic bronchitis who continue to have exacerbations despite inhaled maintenance treatment with combination long-acting β2-agonist and long-acting muscarinic antagonist or with triple therapy with inhaled corticosteroids, long-acting β2-agonist, and long-acting muscarinic antagonist. An alternative, 2024 GOLD-recommended strategy in this population is maintenance therapy with azithromycin, “preferentially in former smokers.” GOLD’s preference for using azithromycin in patients with smoking history is based on post-hoc (ie, not part of the original study design) subgroup analyses “suggesting lesser benefit in active smokers” in the MACRO study. Results of such analyses have not been reported in other studies.
There are no results from clinical trials that have directly compared the harms and benefits of initiating maintenance therapy with roflumilast or azithromycin in patients with COPD. The roflumilast or azithromycin to prevent COPD exacerbations (RELIANCE; NCT04069312) multicenter clinical trial is addressing this evidence gap.7 The RELIANCE study is funded by the Patient-Centered Outcomes Research Institute and co-led by the COPD Foundation, a not-for-profit organization founded by John W. Walsh, a patient advocate with α1-related COPD. Also, results of two recently completed phase 3 clinical trials with nebulized ensifentrine (ENHANCE-1 and ENHANCE-2), a novel inhibitor of PDE3 and PDE4, were recently published. ENHANCE-1 and ENHANCE-2 studies indicate that twice daily nebulized ensifentrine reduces the risk of COPD exacerbations in patients with moderate or severe COPD.8 Ensifentrine is under review by the FDA, and a decision about its use in the US is expected in the summer of 2024.
Until the results from the RELIANCE clinical trial and the decision by the FDA about ensifentrine are available, we recommended a discussion with Ms. Turner about whether to initiate treatment with maintenance roflumilast or azithromycin. Both can reduce the risk of exacerbations, and the relative benefits and risks of these two evidence-based options are not yet known. Unless Ms. Turner has specific preferences (eg, concerns about specific adverse effects or differences in out-of-pocket cost) in favor of one over the other, she could flip a coin to decide between initiating maintenance roflumilast or azithromycin.
Dr. Krishnan is Professor of Medicine, Division of Pulmonary, Critical Care, Sleep & Allergy, and Professor of Public Health, Division of Epidemiology and Biostatistics, University of Illinois Chicago. Dr. Adrish is Associate Professor, Pulmonary, Critical Care and Sleep Medicine, Baylor College of Medicine, Houston.
References:
1. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: 2024 report. https://goldcopd.org/2024-gold-report-2/
2. US Food and Drug Administration (Daliresp®). https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022522s003lbl.pdf
3. Albert RK, Connett J, Bailey WC, et al; COPD Clinical Research Network. Azithromucin for prevention of exacerbations of COPD. N Engl J Med. 2011;365(8):689-98. PMID: 21864166. doi: 10.1056/NEJMoa1104623.
4. US Food and Drug Administration (Zithromyax®). https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf
5. Criner GJ, Bourbeau J, Diekemper RL, et al. Prevention of acure exacerbations of COPD: American College of Chest Physicians and Canadian Thoracic Society guideline. Chest. 2015;147(4)894-942. PMID: 25321320. doi: 10.1378/chest.14-1676.
6. Wedzicha JA, Calverley PMA, Albert RK, et al. Prevention of COPD exacerbations: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2017;50(3):1602265. PMID: 28889106. doi:10.1183/13993003.02265-2016.
7. Krishnan JA, Albert RK, Rennard SI; RELIANCE study. Waiting for actionable evidence: roflumilast or azithromycin? Chronic Obst Pulm Dis. 2022;9(1):1-3. PMID: 34783231. doi: 10.15326/jcopdf.2021.0272.
8. Anzueto A, Barjaktarevic IZ, Siler TM, et al. Ensifentrine, a novel phospodiesterase 3 and 4 inhibitor for the treatment of chronic obstructive pulmonary disease: randomized, double-blind, placebo-controlled, multicenter phase III trials (the ENHANCE trials). Am J Respir Crit Care Med. 2023;208(4):406-416. PMID: 37364283.
“Janice Turner” (name changed to protect confidentiality) is a 66-year-old woman with a 40-pack per year history of smoking. She quit smoking 1 year ago and presents to your office for a follow-up visit after discharge from the hospital 14 days ago. This was her second hospitalization for a COPD exacerbation in the past 12 months. She is very worried about having another COPD exacerbation and wants to know if there are additional medications she could try.
Over the past 2 weeks, her respiratory symptoms have improved and returned to her baseline. She has a daily cough with white phlegm on most days and dyspnea on exertion at one-half block on level ground. She reports using her medications as prescribed and is enrolled in a pulmonary rehabilitation program, which she attends twice per week. She uses 2 to 4 inhalations of albuterol each day.
CHEST
Dr. Jerry A. Krishnan
She is on the following regimen for her COPD, which is unchanged compared with what she has been prescribed for the past 12 months: 1) combination inhaled fluticasone furoate, umeclidinium, and vilanterol via the Ellipta® device, one actuation once daily and 2) inhaled albuterol, two puffs as needed every 4 hours via metered dose inhaler. She demonstrates mastery of inhaler technique for both inhaled devices. Her vaccinations are current (pneumococcus, influenza, respiratory syncytial virus, and COVID-19).
On examination, she can complete sentences without respiratory difficulty, and her vital signs are normal. She has decreased breath sounds in all lung fields, with occasional rhonchi. Heart sounds are distant, but regular, at 92 beats per minute, and she has no peripheral edema. Arterial blood gas at rest on room air indicates a pH of 7.38, PaO2 of 63 mm Hg, and PaCO2 of 42 mm Hg. An electrocardiogram shows sinus rhythm and a QTc interval of 420 milliseconds.
Three months ago, when she was clinically stable, you obtained spirometry, a complete blood count with differential, and a chest radiograph to exclude alternate diagnoses for her ongoing respiratory symptoms. She had severe airflow limitation (post-bronchodilator FEV1 = 40% predicted, FVC = 61% predicted, FEV1/FVC = 65%). At the time, she also had peripheral eosinophilia (eosinophil count of 350 cells/μL) and hyperinflation without parenchymal infiltrates.
CHEST
Dr. Muhammad Adrish
In summary, Ms. Turner has severe smoking-associated COPD Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 3E and chronic bronchitis with two severe exacerbations in the past 12 months.1 She is currently prescribed triple inhaled maintenance therapy with corticosteroids, long-acting β2-agonist, and long-acting muscarinic antagonist. She has a normal QTc interval.
So what would you recommend to reduce Ms. Turner’s risk of future exacerbations?
In 2011, the US Food and Drug Administration (FDA) approved roflumilast 500 mcg by mouth per day, a selective phosphodiesterase 4 (PDE4) inhibitor, as maintenance therapy to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis.2 The FDA approval was based on a review of the efficacy and safety of roflumilast in eight randomized, double-blind, controlled clinical trials in 9,394 adults with COPD.
Two subsequently completed randomized clinical trials in 2015 (REACT, 1,945 adults) and 2016 (RE2SPOND, 2,354 adults) also found that maintenance oral treatment escalation with roflumilast significantly reduced the risk of COPD exacerbations compared with placebo.2 The most common adverse effects reported with long-term use of roflumilast are related to the gastrointestinal tract (diarrhea, nausea, decreased appetite), weight loss, and insomnia. Four weeks of roflumilast at 250 mcg per day prior to dose escalation to 500 mcg per day reduces the risk of treatment discontinuation and improves tolerability compared with initiating treatment with the maintenance dose.
In 2022, the FDA approved a generic version of roflumilast, providing an opportunity for patients to use roflumilast at a lower cost than was previously possible. Importantly, the FDA Prescribing Information includes a warning to avoid the use of roflumilast in patients being treated with strong cytochrome P450 enzyme inducers (eg, rifampin, phenytoin). The FDA Prescribing Information also recommends weighing the risks and benefits of roflumilast in patients with a history of depression or suicidal thoughts or behavior, or patients with unexplained or clinically significant weight loss.
In 2011 (the same year as the FDA approval of roflumilast), the National Institutes of Health/National Heart, Lung, and Blood Institute-funded COPD Clinical Research Network reported that maintenance treatment with azithromycin reduced the risk of COPD exacerbations compared with placebo in a randomized clinical trial of 1,142 adults with COPD (MACRO study).3 Subgroup analyses indicated that the reduction in the risk of COPD exacerbations with azithromycin was observed in participants with or without chronic bronchitis but not in participants who currently smoked.
Subsequently, two other smaller randomized clinical trials in 2014 (COLUMBUS, 92 participants) and in 2019 (BACE, 301 participants) also demonstrated a reduction in the risk of COPD exacerbations with maintenance azithromycin treatment compared with placebo. Azithromycin can prolong the QT interval and, in rare cases, cause cardiac arrythmias, especially when used with other medications that can prolong the QT interval. There are also concerns that maintenance azithromycin therapy could lead to decrements in hearing or promote the development of macrolide-resistant bacteria. Maintenance treatment with azithromycin to prevent COPD exacerbations is not an FDA-approved indication.4 The FDA approval for azithromycin is currently limited to treatment of patients with mild to moderate infections caused by susceptible bacteria, but it is often prescribed off-label as maintenance treatment for COPD.
On the basis of this body of evidence from clinical trials in COPD, the 2015 CHEST and Canadian Thoracic Society (CTS) guidelines,5 the 2017 European Respiratory Society/American Thoracic Society (ERS/ATS) guidelines,6 and the 2024 GOLD Strategy Report all include recommendations for treatment escalation with maintenance roflumilast or azithromycin to reduce the risk of COPD exacerbations. For example, the 2024 GOLD Strategy Report recommends roflumilast in patients with severe COPD and chronic bronchitis who continue to have exacerbations despite inhaled maintenance treatment with combination long-acting β2-agonist and long-acting muscarinic antagonist or with triple therapy with inhaled corticosteroids, long-acting β2-agonist, and long-acting muscarinic antagonist. An alternative, 2024 GOLD-recommended strategy in this population is maintenance therapy with azithromycin, “preferentially in former smokers.” GOLD’s preference for using azithromycin in patients with smoking history is based on post-hoc (ie, not part of the original study design) subgroup analyses “suggesting lesser benefit in active smokers” in the MACRO study. Results of such analyses have not been reported in other studies.
There are no results from clinical trials that have directly compared the harms and benefits of initiating maintenance therapy with roflumilast or azithromycin in patients with COPD. The roflumilast or azithromycin to prevent COPD exacerbations (RELIANCE; NCT04069312) multicenter clinical trial is addressing this evidence gap.7 The RELIANCE study is funded by the Patient-Centered Outcomes Research Institute and co-led by the COPD Foundation, a not-for-profit organization founded by John W. Walsh, a patient advocate with α1-related COPD. Also, results of two recently completed phase 3 clinical trials with nebulized ensifentrine (ENHANCE-1 and ENHANCE-2), a novel inhibitor of PDE3 and PDE4, were recently published. ENHANCE-1 and ENHANCE-2 studies indicate that twice daily nebulized ensifentrine reduces the risk of COPD exacerbations in patients with moderate or severe COPD.8 Ensifentrine is under review by the FDA, and a decision about its use in the US is expected in the summer of 2024.
Until the results from the RELIANCE clinical trial and the decision by the FDA about ensifentrine are available, we recommended a discussion with Ms. Turner about whether to initiate treatment with maintenance roflumilast or azithromycin. Both can reduce the risk of exacerbations, and the relative benefits and risks of these two evidence-based options are not yet known. Unless Ms. Turner has specific preferences (eg, concerns about specific adverse effects or differences in out-of-pocket cost) in favor of one over the other, she could flip a coin to decide between initiating maintenance roflumilast or azithromycin.
Dr. Krishnan is Professor of Medicine, Division of Pulmonary, Critical Care, Sleep & Allergy, and Professor of Public Health, Division of Epidemiology and Biostatistics, University of Illinois Chicago. Dr. Adrish is Associate Professor, Pulmonary, Critical Care and Sleep Medicine, Baylor College of Medicine, Houston.
References:
1. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: 2024 report. https://goldcopd.org/2024-gold-report-2/
2. US Food and Drug Administration (Daliresp®). https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022522s003lbl.pdf
3. Albert RK, Connett J, Bailey WC, et al; COPD Clinical Research Network. Azithromucin for prevention of exacerbations of COPD. N Engl J Med. 2011;365(8):689-98. PMID: 21864166. doi: 10.1056/NEJMoa1104623.
4. US Food and Drug Administration (Zithromyax®). https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf
5. Criner GJ, Bourbeau J, Diekemper RL, et al. Prevention of acure exacerbations of COPD: American College of Chest Physicians and Canadian Thoracic Society guideline. Chest. 2015;147(4)894-942. PMID: 25321320. doi: 10.1378/chest.14-1676.
6. Wedzicha JA, Calverley PMA, Albert RK, et al. Prevention of COPD exacerbations: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2017;50(3):1602265. PMID: 28889106. doi:10.1183/13993003.02265-2016.
7. Krishnan JA, Albert RK, Rennard SI; RELIANCE study. Waiting for actionable evidence: roflumilast or azithromycin? Chronic Obst Pulm Dis. 2022;9(1):1-3. PMID: 34783231. doi: 10.15326/jcopdf.2021.0272.
8. Anzueto A, Barjaktarevic IZ, Siler TM, et al. Ensifentrine, a novel phospodiesterase 3 and 4 inhibitor for the treatment of chronic obstructive pulmonary disease: randomized, double-blind, placebo-controlled, multicenter phase III trials (the ENHANCE trials). Am J Respir Crit Care Med. 2023;208(4):406-416. PMID: 37364283.
“Janice Turner” (name changed to protect confidentiality) is a 66-year-old woman with a 40-pack per year history of smoking. She quit smoking 1 year ago and presents to your office for a follow-up visit after discharge from the hospital 14 days ago. This was her second hospitalization for a COPD exacerbation in the past 12 months. She is very worried about having another COPD exacerbation and wants to know if there are additional medications she could try.
Over the past 2 weeks, her respiratory symptoms have improved and returned to her baseline. She has a daily cough with white phlegm on most days and dyspnea on exertion at one-half block on level ground. She reports using her medications as prescribed and is enrolled in a pulmonary rehabilitation program, which she attends twice per week. She uses 2 to 4 inhalations of albuterol each day.
CHEST
Dr. Jerry A. Krishnan
She is on the following regimen for her COPD, which is unchanged compared with what she has been prescribed for the past 12 months: 1) combination inhaled fluticasone furoate, umeclidinium, and vilanterol via the Ellipta® device, one actuation once daily and 2) inhaled albuterol, two puffs as needed every 4 hours via metered dose inhaler. She demonstrates mastery of inhaler technique for both inhaled devices. Her vaccinations are current (pneumococcus, influenza, respiratory syncytial virus, and COVID-19).
On examination, she can complete sentences without respiratory difficulty, and her vital signs are normal. She has decreased breath sounds in all lung fields, with occasional rhonchi. Heart sounds are distant, but regular, at 92 beats per minute, and she has no peripheral edema. Arterial blood gas at rest on room air indicates a pH of 7.38, PaO2 of 63 mm Hg, and PaCO2 of 42 mm Hg. An electrocardiogram shows sinus rhythm and a QTc interval of 420 milliseconds.
Three months ago, when she was clinically stable, you obtained spirometry, a complete blood count with differential, and a chest radiograph to exclude alternate diagnoses for her ongoing respiratory symptoms. She had severe airflow limitation (post-bronchodilator FEV1 = 40% predicted, FVC = 61% predicted, FEV1/FVC = 65%). At the time, she also had peripheral eosinophilia (eosinophil count of 350 cells/μL) and hyperinflation without parenchymal infiltrates.
CHEST
Dr. Muhammad Adrish
In summary, Ms. Turner has severe smoking-associated COPD Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 3E and chronic bronchitis with two severe exacerbations in the past 12 months.1 She is currently prescribed triple inhaled maintenance therapy with corticosteroids, long-acting β2-agonist, and long-acting muscarinic antagonist. She has a normal QTc interval.
So what would you recommend to reduce Ms. Turner’s risk of future exacerbations?
In 2011, the US Food and Drug Administration (FDA) approved roflumilast 500 mcg by mouth per day, a selective phosphodiesterase 4 (PDE4) inhibitor, as maintenance therapy to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis.2 The FDA approval was based on a review of the efficacy and safety of roflumilast in eight randomized, double-blind, controlled clinical trials in 9,394 adults with COPD.
Two subsequently completed randomized clinical trials in 2015 (REACT, 1,945 adults) and 2016 (RE2SPOND, 2,354 adults) also found that maintenance oral treatment escalation with roflumilast significantly reduced the risk of COPD exacerbations compared with placebo.2 The most common adverse effects reported with long-term use of roflumilast are related to the gastrointestinal tract (diarrhea, nausea, decreased appetite), weight loss, and insomnia. Four weeks of roflumilast at 250 mcg per day prior to dose escalation to 500 mcg per day reduces the risk of treatment discontinuation and improves tolerability compared with initiating treatment with the maintenance dose.
In 2022, the FDA approved a generic version of roflumilast, providing an opportunity for patients to use roflumilast at a lower cost than was previously possible. Importantly, the FDA Prescribing Information includes a warning to avoid the use of roflumilast in patients being treated with strong cytochrome P450 enzyme inducers (eg, rifampin, phenytoin). The FDA Prescribing Information also recommends weighing the risks and benefits of roflumilast in patients with a history of depression or suicidal thoughts or behavior, or patients with unexplained or clinically significant weight loss.
In 2011 (the same year as the FDA approval of roflumilast), the National Institutes of Health/National Heart, Lung, and Blood Institute-funded COPD Clinical Research Network reported that maintenance treatment with azithromycin reduced the risk of COPD exacerbations compared with placebo in a randomized clinical trial of 1,142 adults with COPD (MACRO study).3 Subgroup analyses indicated that the reduction in the risk of COPD exacerbations with azithromycin was observed in participants with or without chronic bronchitis but not in participants who currently smoked.
Subsequently, two other smaller randomized clinical trials in 2014 (COLUMBUS, 92 participants) and in 2019 (BACE, 301 participants) also demonstrated a reduction in the risk of COPD exacerbations with maintenance azithromycin treatment compared with placebo. Azithromycin can prolong the QT interval and, in rare cases, cause cardiac arrythmias, especially when used with other medications that can prolong the QT interval. There are also concerns that maintenance azithromycin therapy could lead to decrements in hearing or promote the development of macrolide-resistant bacteria. Maintenance treatment with azithromycin to prevent COPD exacerbations is not an FDA-approved indication.4 The FDA approval for azithromycin is currently limited to treatment of patients with mild to moderate infections caused by susceptible bacteria, but it is often prescribed off-label as maintenance treatment for COPD.
On the basis of this body of evidence from clinical trials in COPD, the 2015 CHEST and Canadian Thoracic Society (CTS) guidelines,5 the 2017 European Respiratory Society/American Thoracic Society (ERS/ATS) guidelines,6 and the 2024 GOLD Strategy Report all include recommendations for treatment escalation with maintenance roflumilast or azithromycin to reduce the risk of COPD exacerbations. For example, the 2024 GOLD Strategy Report recommends roflumilast in patients with severe COPD and chronic bronchitis who continue to have exacerbations despite inhaled maintenance treatment with combination long-acting β2-agonist and long-acting muscarinic antagonist or with triple therapy with inhaled corticosteroids, long-acting β2-agonist, and long-acting muscarinic antagonist. An alternative, 2024 GOLD-recommended strategy in this population is maintenance therapy with azithromycin, “preferentially in former smokers.” GOLD’s preference for using azithromycin in patients with smoking history is based on post-hoc (ie, not part of the original study design) subgroup analyses “suggesting lesser benefit in active smokers” in the MACRO study. Results of such analyses have not been reported in other studies.
There are no results from clinical trials that have directly compared the harms and benefits of initiating maintenance therapy with roflumilast or azithromycin in patients with COPD. The roflumilast or azithromycin to prevent COPD exacerbations (RELIANCE; NCT04069312) multicenter clinical trial is addressing this evidence gap.7 The RELIANCE study is funded by the Patient-Centered Outcomes Research Institute and co-led by the COPD Foundation, a not-for-profit organization founded by John W. Walsh, a patient advocate with α1-related COPD. Also, results of two recently completed phase 3 clinical trials with nebulized ensifentrine (ENHANCE-1 and ENHANCE-2), a novel inhibitor of PDE3 and PDE4, were recently published. ENHANCE-1 and ENHANCE-2 studies indicate that twice daily nebulized ensifentrine reduces the risk of COPD exacerbations in patients with moderate or severe COPD.8 Ensifentrine is under review by the FDA, and a decision about its use in the US is expected in the summer of 2024.
Until the results from the RELIANCE clinical trial and the decision by the FDA about ensifentrine are available, we recommended a discussion with Ms. Turner about whether to initiate treatment with maintenance roflumilast or azithromycin. Both can reduce the risk of exacerbations, and the relative benefits and risks of these two evidence-based options are not yet known. Unless Ms. Turner has specific preferences (eg, concerns about specific adverse effects or differences in out-of-pocket cost) in favor of one over the other, she could flip a coin to decide between initiating maintenance roflumilast or azithromycin.
Dr. Krishnan is Professor of Medicine, Division of Pulmonary, Critical Care, Sleep & Allergy, and Professor of Public Health, Division of Epidemiology and Biostatistics, University of Illinois Chicago. Dr. Adrish is Associate Professor, Pulmonary, Critical Care and Sleep Medicine, Baylor College of Medicine, Houston.
References:
1. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: 2024 report. https://goldcopd.org/2024-gold-report-2/
2. US Food and Drug Administration (Daliresp®). https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022522s003lbl.pdf
3. Albert RK, Connett J, Bailey WC, et al; COPD Clinical Research Network. Azithromucin for prevention of exacerbations of COPD. N Engl J Med. 2011;365(8):689-98. PMID: 21864166. doi: 10.1056/NEJMoa1104623.
4. US Food and Drug Administration (Zithromyax®). https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf
5. Criner GJ, Bourbeau J, Diekemper RL, et al. Prevention of acure exacerbations of COPD: American College of Chest Physicians and Canadian Thoracic Society guideline. Chest. 2015;147(4)894-942. PMID: 25321320. doi: 10.1378/chest.14-1676.
6. Wedzicha JA, Calverley PMA, Albert RK, et al. Prevention of COPD exacerbations: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2017;50(3):1602265. PMID: 28889106. doi:10.1183/13993003.02265-2016.
7. Krishnan JA, Albert RK, Rennard SI; RELIANCE study. Waiting for actionable evidence: roflumilast or azithromycin? Chronic Obst Pulm Dis. 2022;9(1):1-3. PMID: 34783231. doi: 10.15326/jcopdf.2021.0272.
8. Anzueto A, Barjaktarevic IZ, Siler TM, et al. Ensifentrine, a novel phospodiesterase 3 and 4 inhibitor for the treatment of chronic obstructive pulmonary disease: randomized, double-blind, placebo-controlled, multicenter phase III trials (the ENHANCE trials). Am J Respir Crit Care Med. 2023;208(4):406-416. PMID: 37364283.
