People receiving the Johnson and Johnson COVID-19 vaccine could be at increased risk for developing Guillain-Barré syndrome, the Food and Drug Administration is expected to announce as early as July 13, according to multiple media reports.

Although the FDA is projected to add the new warning to the labeling for the vaccine, the agency still calculates the benefit of vaccination with the J&J product continues to outweigh the risk. Benefits include protection against the Delta variant and serious COVID-19 outcomes.

More than 100 cases of Guillain-Barré reported to the Vaccine Adverse Event Reporting System, a federal program for reporting vaccine issues, spurred the FDA to act.

Men and people older than 50 appear to be at highest risk, according to reports of a July 12 Centers for Disease Control and Prevention statement. The CDC also revealed that most cases occur about 2 weeks following immunization.

Guillain-Barré syndrome often causes muscle weakness and sometimes temporary paralysis. Most people who develop the rare syndrome recover.

Such was not the case for a 57-year-old man, the New York Times reported July 12. He had a history of both a heart attack and stroke in the previous 4 years and died in April after vaccination with the J&J vaccine and developing Guillain-Barré.

The new warning comes in the wake of a number of setbacks for the company’s COVID-19 vaccine. On April 13, the FDA and CDC both recommended a 10-day pause on administration of the J&J vaccine after reports of rare blood clot events emerged. In mid-June, the FDA requested that Johnson and Johnson discard millions of vaccine doses produced at a manufacturing facility in Baltimore.

The mRNA vaccines from Pfizer/BioNTech and Moderna are not affected by the new FDA warning.

The Biden administration is expected to make a formal announcement of the new warning for the Johnson and Johnson vaccine as early as July 13, the Times reports.

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

People receiving the Johnson and Johnson COVID-19 vaccine could be at increased risk for developing Guillain-Barré syndrome, the Food and Drug Administration is expected to announce as early as July 13, according to multiple media reports.

Although the FDA is projected to add the new warning to the labeling for the vaccine, the agency still calculates the benefit of vaccination with the J&J product continues to outweigh the risk. Benefits include protection against the Delta variant and serious COVID-19 outcomes.

More than 100 cases of Guillain-Barré reported to the Vaccine Adverse Event Reporting System, a federal program for reporting vaccine issues, spurred the FDA to act.

Men and people older than 50 appear to be at highest risk, according to reports of a July 12 Centers for Disease Control and Prevention statement. The CDC also revealed that most cases occur about 2 weeks following immunization.

Guillain-Barré syndrome often causes muscle weakness and sometimes temporary paralysis. Most people who develop the rare syndrome recover.

Such was not the case for a 57-year-old man, the New York Times reported July 12. He had a history of both a heart attack and stroke in the previous 4 years and died in April after vaccination with the J&J vaccine and developing Guillain-Barré.

The new warning comes in the wake of a number of setbacks for the company’s COVID-19 vaccine. On April 13, the FDA and CDC both recommended a 10-day pause on administration of the J&J vaccine after reports of rare blood clot events emerged. In mid-June, the FDA requested that Johnson and Johnson discard millions of vaccine doses produced at a manufacturing facility in Baltimore.

The mRNA vaccines from Pfizer/BioNTech and Moderna are not affected by the new FDA warning.

The Biden administration is expected to make a formal announcement of the new warning for the Johnson and Johnson vaccine as early as July 13, the Times reports.

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

People receiving the Johnson and Johnson COVID-19 vaccine could be at increased risk for developing Guillain-Barré syndrome, the Food and Drug Administration is expected to announce as early as July 13, according to multiple media reports.

Although the FDA is projected to add the new warning to the labeling for the vaccine, the agency still calculates the benefit of vaccination with the J&J product continues to outweigh the risk. Benefits include protection against the Delta variant and serious COVID-19 outcomes.

More than 100 cases of Guillain-Barré reported to the Vaccine Adverse Event Reporting System, a federal program for reporting vaccine issues, spurred the FDA to act.

Men and people older than 50 appear to be at highest risk, according to reports of a July 12 Centers for Disease Control and Prevention statement. The CDC also revealed that most cases occur about 2 weeks following immunization.

Guillain-Barré syndrome often causes muscle weakness and sometimes temporary paralysis. Most people who develop the rare syndrome recover.

Such was not the case for a 57-year-old man, the New York Times reported July 12. He had a history of both a heart attack and stroke in the previous 4 years and died in April after vaccination with the J&J vaccine and developing Guillain-Barré.

The new warning comes in the wake of a number of setbacks for the company’s COVID-19 vaccine. On April 13, the FDA and CDC both recommended a 10-day pause on administration of the J&J vaccine after reports of rare blood clot events emerged. In mid-June, the FDA requested that Johnson and Johnson discard millions of vaccine doses produced at a manufacturing facility in Baltimore.

The mRNA vaccines from Pfizer/BioNTech and Moderna are not affected by the new FDA warning.

The Biden administration is expected to make a formal announcement of the new warning for the Johnson and Johnson vaccine as early as July 13, the Times reports.

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

Patients with infected pancreatic necrosis (IPN) are more likely to experience organ failure and mortality, which makes identifying them as quickly as possible especially crucial. A new study aimed to make this task a bit easier by categorizing the main risk factors for IPN in a cohort of patients with severe acute pancreatitis, which included extensive spread of necrotic collections, preceding bacteremia, and preceding open abdomen treatment, as well as postinterventional pancreatitis.

In their study, published in the Journal of Gastrointestinal Surgery, Henrik L. Husu, MD, of the University of Helsinki, and colleagues noted the inherent challenges of rendering a preoperative diagnosis of IPN.

“Fever and increasing inflammation markers may indicate suspicion of IPN, but these are very common in patients with severe acute pancreatitis treated in the ICU,” and more knowledge of specific IPN risk factors is needed to improve clinical decision-making, they said.

Dr. Husu and colleagues identified 163 adults with acute pancreatitis admitted to the ICU at a single center between 2010 and 2018, approximately 68% of whom had alcoholic necrotizing pancreatitis. Pneumonia, bacteremia, and IPN occurred at an average of 4, 16, and 23 days, respectively, after ICU admission.

Forty-seven patients (28.8%) developed IPN within 90 days of ICU admission, all patients had a least one persistent organ failure, and 60% had multiple organ failure within 24 hours of ICU admission.

In a multivariate regression analysis, independent risk factors for IPN included postoperative or postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (odds ratio,13.5) and widespread necrotic collections (OR, 5.7 for unilateral paracolic or retromesenteric; OR, 21.8 for bilateral paracolic or unilateral paracolic and retromesenteric). Other risk factors were preceding bacteremia (OR, 4.8) and preceding open abdomen treatment for abdominal compartment syndrome (OR, 3.6).

After 90 days, 29 patients had died, including 7 with IPN and 22 without IPN. In addition, patients with IPN had longer overall hospital stays and ICU stays, higher rates of ICU readmission, and greater use of open necrosectomy, the researchers noted.

The study findings were limited by several factors, including the retrospective design, lack of controls, potential differences in treatment protocols, and the survival bias that prevented direct comparison of mortality in patients with and without IPN, the researchers noted. “This study cannot provide a reliable estimate of the difference in mortality attributable to IPN itself.”

However, the researchers noted that “the strength of the present study was to include only patients with persistent organ failure and admission to ICU in the early disease course,” and results indicate a significant morbid outcome associated with IPN. “In attempting to decrease the rate of IPN, efforts to identify and treat incipient organ failure with subsequent low threshold for admission to ICU becomes essential,” they emphasized. 
 

More data may prompt greater intervention

“IPN portends a poor prognosis, and can be challenging to both diagnose and treat,” Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview. “Identifying risk factors for development of IPN may facilitate earlier therapy that could modify the natural history of this disease.”

Dr. Ketwaroo said he was not surprised by the study findings. “This was a small single-center, retrospective study, where infection could only be ascertained among those who received interventions, and the findings should thus be interpreted within these limitations. Overall, however, I was not surprised. More extensive necrosis and opportunities for infectious seeding of necrosis such as interventions (ERCP) and bacteremia would be expected risk factors. I was surprised by the use of prophylactic antibiotics, as well as the high rate of open necrosectomy, though this should not affect the main findings of risk factors for infection.

“The studies highlight that a significant portion of patients with severe acute pancreatitis with necrosis will develop infection,” said Dr. Ketwaroo. “Being aware of the risk factors for infection, as identified in this study, can add to our clinical judgment in suspecting infection and opting for debridement. Especially with advancements in endoscopic necrosectomy, gastroenterologists may be more inclined to intervene when suspecting IPN. The next steps for research are to validate risk factors in larger, prospective studies.”

The study was supported by governmental competitive funds for medical research, a research grant from the Medical Society of Finland, and a research grant from Perkléns Foundation. The researchers had no financial conflicts to disclose. Dr. Ketwaroo had no financial conflicts to disclose but is a member of the GI & Hepatology News editorial advisory board.

Patients with infected pancreatic necrosis (IPN) are more likely to experience organ failure and mortality, which makes identifying them as quickly as possible especially crucial. A new study aimed to make this task a bit easier by categorizing the main risk factors for IPN in a cohort of patients with severe acute pancreatitis, which included extensive spread of necrotic collections, preceding bacteremia, and preceding open abdomen treatment, as well as postinterventional pancreatitis.

In their study, published in the Journal of Gastrointestinal Surgery, Henrik L. Husu, MD, of the University of Helsinki, and colleagues noted the inherent challenges of rendering a preoperative diagnosis of IPN.

“Fever and increasing inflammation markers may indicate suspicion of IPN, but these are very common in patients with severe acute pancreatitis treated in the ICU,” and more knowledge of specific IPN risk factors is needed to improve clinical decision-making, they said.

Dr. Husu and colleagues identified 163 adults with acute pancreatitis admitted to the ICU at a single center between 2010 and 2018, approximately 68% of whom had alcoholic necrotizing pancreatitis. Pneumonia, bacteremia, and IPN occurred at an average of 4, 16, and 23 days, respectively, after ICU admission.

Forty-seven patients (28.8%) developed IPN within 90 days of ICU admission, all patients had a least one persistent organ failure, and 60% had multiple organ failure within 24 hours of ICU admission.

In a multivariate regression analysis, independent risk factors for IPN included postoperative or postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (odds ratio,13.5) and widespread necrotic collections (OR, 5.7 for unilateral paracolic or retromesenteric; OR, 21.8 for bilateral paracolic or unilateral paracolic and retromesenteric). Other risk factors were preceding bacteremia (OR, 4.8) and preceding open abdomen treatment for abdominal compartment syndrome (OR, 3.6).

After 90 days, 29 patients had died, including 7 with IPN and 22 without IPN. In addition, patients with IPN had longer overall hospital stays and ICU stays, higher rates of ICU readmission, and greater use of open necrosectomy, the researchers noted.

The study findings were limited by several factors, including the retrospective design, lack of controls, potential differences in treatment protocols, and the survival bias that prevented direct comparison of mortality in patients with and without IPN, the researchers noted. “This study cannot provide a reliable estimate of the difference in mortality attributable to IPN itself.”

However, the researchers noted that “the strength of the present study was to include only patients with persistent organ failure and admission to ICU in the early disease course,” and results indicate a significant morbid outcome associated with IPN. “In attempting to decrease the rate of IPN, efforts to identify and treat incipient organ failure with subsequent low threshold for admission to ICU becomes essential,” they emphasized. 
 

More data may prompt greater intervention

“IPN portends a poor prognosis, and can be challenging to both diagnose and treat,” Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview. “Identifying risk factors for development of IPN may facilitate earlier therapy that could modify the natural history of this disease.”

Dr. Ketwaroo said he was not surprised by the study findings. “This was a small single-center, retrospective study, where infection could only be ascertained among those who received interventions, and the findings should thus be interpreted within these limitations. Overall, however, I was not surprised. More extensive necrosis and opportunities for infectious seeding of necrosis such as interventions (ERCP) and bacteremia would be expected risk factors. I was surprised by the use of prophylactic antibiotics, as well as the high rate of open necrosectomy, though this should not affect the main findings of risk factors for infection.

“The studies highlight that a significant portion of patients with severe acute pancreatitis with necrosis will develop infection,” said Dr. Ketwaroo. “Being aware of the risk factors for infection, as identified in this study, can add to our clinical judgment in suspecting infection and opting for debridement. Especially with advancements in endoscopic necrosectomy, gastroenterologists may be more inclined to intervene when suspecting IPN. The next steps for research are to validate risk factors in larger, prospective studies.”

The study was supported by governmental competitive funds for medical research, a research grant from the Medical Society of Finland, and a research grant from Perkléns Foundation. The researchers had no financial conflicts to disclose. Dr. Ketwaroo had no financial conflicts to disclose but is a member of the GI & Hepatology News editorial advisory board.

Patients with infected pancreatic necrosis (IPN) are more likely to experience organ failure and mortality, which makes identifying them as quickly as possible especially crucial. A new study aimed to make this task a bit easier by categorizing the main risk factors for IPN in a cohort of patients with severe acute pancreatitis, which included extensive spread of necrotic collections, preceding bacteremia, and preceding open abdomen treatment, as well as postinterventional pancreatitis.

In their study, published in the Journal of Gastrointestinal Surgery, Henrik L. Husu, MD, of the University of Helsinki, and colleagues noted the inherent challenges of rendering a preoperative diagnosis of IPN.

“Fever and increasing inflammation markers may indicate suspicion of IPN, but these are very common in patients with severe acute pancreatitis treated in the ICU,” and more knowledge of specific IPN risk factors is needed to improve clinical decision-making, they said.

Dr. Husu and colleagues identified 163 adults with acute pancreatitis admitted to the ICU at a single center between 2010 and 2018, approximately 68% of whom had alcoholic necrotizing pancreatitis. Pneumonia, bacteremia, and IPN occurred at an average of 4, 16, and 23 days, respectively, after ICU admission.

Forty-seven patients (28.8%) developed IPN within 90 days of ICU admission, all patients had a least one persistent organ failure, and 60% had multiple organ failure within 24 hours of ICU admission.

In a multivariate regression analysis, independent risk factors for IPN included postoperative or postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (odds ratio,13.5) and widespread necrotic collections (OR, 5.7 for unilateral paracolic or retromesenteric; OR, 21.8 for bilateral paracolic or unilateral paracolic and retromesenteric). Other risk factors were preceding bacteremia (OR, 4.8) and preceding open abdomen treatment for abdominal compartment syndrome (OR, 3.6).

After 90 days, 29 patients had died, including 7 with IPN and 22 without IPN. In addition, patients with IPN had longer overall hospital stays and ICU stays, higher rates of ICU readmission, and greater use of open necrosectomy, the researchers noted.

The study findings were limited by several factors, including the retrospective design, lack of controls, potential differences in treatment protocols, and the survival bias that prevented direct comparison of mortality in patients with and without IPN, the researchers noted. “This study cannot provide a reliable estimate of the difference in mortality attributable to IPN itself.”

However, the researchers noted that “the strength of the present study was to include only patients with persistent organ failure and admission to ICU in the early disease course,” and results indicate a significant morbid outcome associated with IPN. “In attempting to decrease the rate of IPN, efforts to identify and treat incipient organ failure with subsequent low threshold for admission to ICU becomes essential,” they emphasized. 
 

More data may prompt greater intervention

“IPN portends a poor prognosis, and can be challenging to both diagnose and treat,” Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview. “Identifying risk factors for development of IPN may facilitate earlier therapy that could modify the natural history of this disease.”

Dr. Ketwaroo said he was not surprised by the study findings. “This was a small single-center, retrospective study, where infection could only be ascertained among those who received interventions, and the findings should thus be interpreted within these limitations. Overall, however, I was not surprised. More extensive necrosis and opportunities for infectious seeding of necrosis such as interventions (ERCP) and bacteremia would be expected risk factors. I was surprised by the use of prophylactic antibiotics, as well as the high rate of open necrosectomy, though this should not affect the main findings of risk factors for infection.

“The studies highlight that a significant portion of patients with severe acute pancreatitis with necrosis will develop infection,” said Dr. Ketwaroo. “Being aware of the risk factors for infection, as identified in this study, can add to our clinical judgment in suspecting infection and opting for debridement. Especially with advancements in endoscopic necrosectomy, gastroenterologists may be more inclined to intervene when suspecting IPN. The next steps for research are to validate risk factors in larger, prospective studies.”

The study was supported by governmental competitive funds for medical research, a research grant from the Medical Society of Finland, and a research grant from Perkléns Foundation. The researchers had no financial conflicts to disclose. Dr. Ketwaroo had no financial conflicts to disclose but is a member of the GI & Hepatology News editorial advisory board.

Background

Well into its second year, the worldwide COVID-19 pandemic continues to pose substantial challenges for health care access and delivery. Regulatory agencies such as the Centers for Disease Control (CDC) do not currently have guidance related to COVID-19 specific to sleep centers and laboratories. In March 2020, within days of the World Health Organization pandemic declaration, the American Academy of Sleep Medicine (AASM) posted detailed guidance on mitigation strategies for sleep medicine practices (COVID-19 Resources).

This initial guidance has been previously reported in this publication (Sullivan S, Gurubhagavatula I. CHEST Physician 2020 May 8), and the guidance has been periodically updated during the pandemic. It was restructured in mid-2020 to include sections summarizing CDC recommendations germane for sleep practices; additional sleep medicine-specific guidance from the AASM COVID-19 Task Force (TF); and a frequently asked questions (FAQ) section. The last major update from the task force occurred on Jan. 18, 2021, though subsequent posts – especially related to recent CDC changes in masking guidelines – were made in May 2021. The purpose of this article is to summarize these updates and to call attention to areas of ongoing interest to sleep medicine. Notably, the AASM Task Force guidance is nonbinding and offered as a framework for considering best practices in this evolving situation, acknowledging the importance of weighing local factors, conditions, and regulations, as well as the interests of and risks to the patient, staff, and providers.

Key updates

Data on exposure and transmission risks specific to sleep medicine

Measures for reducing viral transmission have been central to managing the spread of the virus in clinical settings. In its last major update, the AASM TF noted that no known outbreaks of COVID-19 related to sleep center exposure have been reported. A perspective and data published in the Journal of the American Medical Association concluded that hospital transmission of the virus “in the setting of universal masking is likely rare, even during periods of high community prevalence.” It also concluded that hospital-based outbreaks are more likely to occur in small workrooms and during mealtime when staff are less adherent to masking and physical distancing (Richterman A, et al. JAMA. 2020;324[21]:2155-6). The TF elaborated on considerations to reduce transmission, which include not just telework and foundational infection control practices, but also broader workplace considerations such as optimizing ventilation, taking advantage of outdoor spaces (e.g., for breaks and eating), scheduling to reduce interactions between personnel from different teams, minimizing contact in meeting/break rooms, removing tables and chairs from lounge areas, and following CDC guidance for effective facility operations.

Vaccination

In the January update, the AASM COVID-19 TF stated that, “sleep facility leaders should encourage staff and patients to be vaccinated in accordance with CDC guidance.” The role of the sleep medicine community in encouraging healthy sleep habits before and after vaccination was emphasized, pointing to evidence linking sleep and immunity, specifically between sleep duration and vaccination response (Healthy sleep and immune response to COVID-19 vaccination. 2021 Jan.).

In an FAQ update from March 26, 2021, considering whether continued COVID-19 testing was needed following full vaccination, the AASM advised testing prior to potential aerosol-generating procedures should be made on the basis of a risk-benefit assessment by the sleep clinician. Several considerations were highlighted, including recent COVID-19 infection, vaccination status of contacts, local prevalence of newer variants, and whether individuals are receiving positive airway pressure therapy. The TF focused on the vigilance for residents and staff in long-term care facilities, which have been associated with a number of outbreaks.
 

Masking in the context of the COVID-19 vaccine

The most significant change in recommendations is the recent relaxation of masking guidance by the CDC in the setting of the approval and distribution of COVID-19 vaccinations. In May, the CDC stated that fully vaccinated individuals can resume activities without masking or physically distancing except in scenarios of travel and where required by laws, regulations, and local businesses, due to the efficacy of the vaccines, increasing evidence of reduced asymptomatic carriage and transmission after vaccination, and anticipated increased uptake of vaccination. However, the CDC also noted that these updates did not apply to health care facilities, where the recommendation remains that patients and visitors should continue to mask throughout their stay. Additionally, fully vaccinated health care workers should continue to practice infection control measures while working with patients. On May 14, the AASM TF provided a detailed FAQ acknowledging the CDC’s new guidance, emphasizing that masking guidance in health care facilities remains unchanged, and encouraging individuals to follow CDC guidance regarding vaccination, noting that emergence of newer variants continues to be monitored, and existing vaccines still appear to induce neutralizing antibodies even if to a somewhat lower degree. The situation for pediatric sleep centers has been highlighted in particular because the potential risk posed by newer variants to children remains under investigation, and children under age 12 are not approved for vaccination.
 

Important caveats to discussions around vaccination status are the lack of a centralized method to identify vaccinated individuals, the unknown duration of immunity, and reports of the use of fake vaccine cards. At this time, in health care settings, vaccination status should not exempt mask usage for any individual.
 

Sleep medicine care for those with COVID-19

Regarding the duration of isolation and precautions for adults with COVID-19, the TF highlighted the CDC’s symptom-based strategy, rather than test-based strategy, for ending isolation of these patients, availing them of sleep medicine services in person.

In line with the CDC guidance, this approach indicates that scheduling in-person care such as polysomnography for a COVID-19–positive patient may be appropriate at least 10 days after symptom onset (or after a positive test if the patient never developed symptoms); or at least 20 days after symptom onset if the illness was severe; or if at least 90 days have elapsed since symptom onset, consider preappointment COVID-19 screening. In the context of immunocompromised individuals, involvement from infectious disease specialists may be needed to help guide decisions.
 

Patient communications

For many, a repercussion of the pandemic has been delaying care or avoiding addressing medical issues, including sleep disorders. The AASM encouraged practices to consider communicating with patients that delaying needed care can increase health risks; COVID-19 transmission to patients in health care settings has been low; effective safety procedures are in place; and whether remote/telehealth services are available.

Disparities in care

In addition to the specific guidance above, there are ongoing concerns regarding disparities in care resulting from a variety of sources and becoming more evident during the pandemic. Complex factors, ranging from economic, geographic, contextual, occupational, and others contribute to disparities that health care systems – and sleep medicine - have not been able to adequately address (Jackson CL and Johnson DA. J Clin Sleep Med. 16[8]:1401-2). More specific differences may include Internet access, reduced access due to socioeconomic barriers, transportation limitations, medical mistrust, and membership in a medically vulnerable group such as children, the elderly, and those with high acuity needs. For example, in pediatric patients there exist few evidence-based alternatives and guidelines to in-lab testing and care, which may have negatively impacted access to needed sleep medicine services (Sullivan S et al. J Clin Sleep Med. 2021 Mar 1;17[3]:361-2).
 

Economics in the COVID-19 pandemic

The economic effects of COVID-19 on medical institutions and in sleep medicine is a story that continues to unfold. Reductions in patient visits and elective procedures, infection control measures limiting capacity, increased costs to maintain such measures, and variability of responses by payer and region are just a few of the issues. The Centers for Medicare & Medicaid Services has employed waivers to increased flexibility and promote safe and effective care including the use of telemedicine during the public health emergency, but the future of these waivers remains uncertain. Alarmingly, a sizeable portion of sleep practices reported financial solvency concerns related to the pandemic (Ramar K. J Clin Sleep Med. 2020;16[11]:1939-42).

Conclusion

As the COVID-19 pandemic and related public health guidance continues to evolve, sleep medicine practices continue to adapt. Vaccination, new variants, changes in mask guidance, new outbreaks around the globe, financial and staffing uncertainties, as well as addressing disparities in care and outcomes that may be augmented by the pandemic remain salient areas of ongoing development.

Dr. Lee is a Postdoctoral and Pediatric Pulmonary Fellow, Department of Pediatrics, Division of Pulmonary, Asthma, and Sleep Medicine, Stanford University School of Medicine; Dr. Sullivan is Clinical Professor, Department of Pediatrics, Division of Pulmonary, Asthma, and Sleep Medicine, and by courtesy, Division of Sleep Medicine, Department of Psychiatry, Stanford University School of Medicine, Palo Alto, CA.

Background

Well into its second year, the worldwide COVID-19 pandemic continues to pose substantial challenges for health care access and delivery. Regulatory agencies such as the Centers for Disease Control (CDC) do not currently have guidance related to COVID-19 specific to sleep centers and laboratories. In March 2020, within days of the World Health Organization pandemic declaration, the American Academy of Sleep Medicine (AASM) posted detailed guidance on mitigation strategies for sleep medicine practices (COVID-19 Resources).

This initial guidance has been previously reported in this publication (Sullivan S, Gurubhagavatula I. CHEST Physician 2020 May 8), and the guidance has been periodically updated during the pandemic. It was restructured in mid-2020 to include sections summarizing CDC recommendations germane for sleep practices; additional sleep medicine-specific guidance from the AASM COVID-19 Task Force (TF); and a frequently asked questions (FAQ) section. The last major update from the task force occurred on Jan. 18, 2021, though subsequent posts – especially related to recent CDC changes in masking guidelines – were made in May 2021. The purpose of this article is to summarize these updates and to call attention to areas of ongoing interest to sleep medicine. Notably, the AASM Task Force guidance is nonbinding and offered as a framework for considering best practices in this evolving situation, acknowledging the importance of weighing local factors, conditions, and regulations, as well as the interests of and risks to the patient, staff, and providers.

Key updates

Data on exposure and transmission risks specific to sleep medicine

Measures for reducing viral transmission have been central to managing the spread of the virus in clinical settings. In its last major update, the AASM TF noted that no known outbreaks of COVID-19 related to sleep center exposure have been reported. A perspective and data published in the Journal of the American Medical Association concluded that hospital transmission of the virus “in the setting of universal masking is likely rare, even during periods of high community prevalence.” It also concluded that hospital-based outbreaks are more likely to occur in small workrooms and during mealtime when staff are less adherent to masking and physical distancing (Richterman A, et al. JAMA. 2020;324[21]:2155-6). The TF elaborated on considerations to reduce transmission, which include not just telework and foundational infection control practices, but also broader workplace considerations such as optimizing ventilation, taking advantage of outdoor spaces (e.g., for breaks and eating), scheduling to reduce interactions between personnel from different teams, minimizing contact in meeting/break rooms, removing tables and chairs from lounge areas, and following CDC guidance for effective facility operations.

Vaccination

In the January update, the AASM COVID-19 TF stated that, “sleep facility leaders should encourage staff and patients to be vaccinated in accordance with CDC guidance.” The role of the sleep medicine community in encouraging healthy sleep habits before and after vaccination was emphasized, pointing to evidence linking sleep and immunity, specifically between sleep duration and vaccination response (Healthy sleep and immune response to COVID-19 vaccination. 2021 Jan.).

In an FAQ update from March 26, 2021, considering whether continued COVID-19 testing was needed following full vaccination, the AASM advised testing prior to potential aerosol-generating procedures should be made on the basis of a risk-benefit assessment by the sleep clinician. Several considerations were highlighted, including recent COVID-19 infection, vaccination status of contacts, local prevalence of newer variants, and whether individuals are receiving positive airway pressure therapy. The TF focused on the vigilance for residents and staff in long-term care facilities, which have been associated with a number of outbreaks.
 

Masking in the context of the COVID-19 vaccine

The most significant change in recommendations is the recent relaxation of masking guidance by the CDC in the setting of the approval and distribution of COVID-19 vaccinations. In May, the CDC stated that fully vaccinated individuals can resume activities without masking or physically distancing except in scenarios of travel and where required by laws, regulations, and local businesses, due to the efficacy of the vaccines, increasing evidence of reduced asymptomatic carriage and transmission after vaccination, and anticipated increased uptake of vaccination. However, the CDC also noted that these updates did not apply to health care facilities, where the recommendation remains that patients and visitors should continue to mask throughout their stay. Additionally, fully vaccinated health care workers should continue to practice infection control measures while working with patients. On May 14, the AASM TF provided a detailed FAQ acknowledging the CDC’s new guidance, emphasizing that masking guidance in health care facilities remains unchanged, and encouraging individuals to follow CDC guidance regarding vaccination, noting that emergence of newer variants continues to be monitored, and existing vaccines still appear to induce neutralizing antibodies even if to a somewhat lower degree. The situation for pediatric sleep centers has been highlighted in particular because the potential risk posed by newer variants to children remains under investigation, and children under age 12 are not approved for vaccination.
 

Important caveats to discussions around vaccination status are the lack of a centralized method to identify vaccinated individuals, the unknown duration of immunity, and reports of the use of fake vaccine cards. At this time, in health care settings, vaccination status should not exempt mask usage for any individual.
 

Sleep medicine care for those with COVID-19

Regarding the duration of isolation and precautions for adults with COVID-19, the TF highlighted the CDC’s symptom-based strategy, rather than test-based strategy, for ending isolation of these patients, availing them of sleep medicine services in person.

In line with the CDC guidance, this approach indicates that scheduling in-person care such as polysomnography for a COVID-19–positive patient may be appropriate at least 10 days after symptom onset (or after a positive test if the patient never developed symptoms); or at least 20 days after symptom onset if the illness was severe; or if at least 90 days have elapsed since symptom onset, consider preappointment COVID-19 screening. In the context of immunocompromised individuals, involvement from infectious disease specialists may be needed to help guide decisions.
 

Patient communications

For many, a repercussion of the pandemic has been delaying care or avoiding addressing medical issues, including sleep disorders. The AASM encouraged practices to consider communicating with patients that delaying needed care can increase health risks; COVID-19 transmission to patients in health care settings has been low; effective safety procedures are in place; and whether remote/telehealth services are available.

Disparities in care

In addition to the specific guidance above, there are ongoing concerns regarding disparities in care resulting from a variety of sources and becoming more evident during the pandemic. Complex factors, ranging from economic, geographic, contextual, occupational, and others contribute to disparities that health care systems – and sleep medicine - have not been able to adequately address (Jackson CL and Johnson DA. J Clin Sleep Med. 16[8]:1401-2). More specific differences may include Internet access, reduced access due to socioeconomic barriers, transportation limitations, medical mistrust, and membership in a medically vulnerable group such as children, the elderly, and those with high acuity needs. For example, in pediatric patients there exist few evidence-based alternatives and guidelines to in-lab testing and care, which may have negatively impacted access to needed sleep medicine services (Sullivan S et al. J Clin Sleep Med. 2021 Mar 1;17[3]:361-2).
 

Economics in the COVID-19 pandemic

The economic effects of COVID-19 on medical institutions and in sleep medicine is a story that continues to unfold. Reductions in patient visits and elective procedures, infection control measures limiting capacity, increased costs to maintain such measures, and variability of responses by payer and region are just a few of the issues. The Centers for Medicare & Medicaid Services has employed waivers to increased flexibility and promote safe and effective care including the use of telemedicine during the public health emergency, but the future of these waivers remains uncertain. Alarmingly, a sizeable portion of sleep practices reported financial solvency concerns related to the pandemic (Ramar K. J Clin Sleep Med. 2020;16[11]:1939-42).

Conclusion

As the COVID-19 pandemic and related public health guidance continues to evolve, sleep medicine practices continue to adapt. Vaccination, new variants, changes in mask guidance, new outbreaks around the globe, financial and staffing uncertainties, as well as addressing disparities in care and outcomes that may be augmented by the pandemic remain salient areas of ongoing development.

Dr. Lee is a Postdoctoral and Pediatric Pulmonary Fellow, Department of Pediatrics, Division of Pulmonary, Asthma, and Sleep Medicine, Stanford University School of Medicine; Dr. Sullivan is Clinical Professor, Department of Pediatrics, Division of Pulmonary, Asthma, and Sleep Medicine, and by courtesy, Division of Sleep Medicine, Department of Psychiatry, Stanford University School of Medicine, Palo Alto, CA.

Background

Well into its second year, the worldwide COVID-19 pandemic continues to pose substantial challenges for health care access and delivery. Regulatory agencies such as the Centers for Disease Control (CDC) do not currently have guidance related to COVID-19 specific to sleep centers and laboratories. In March 2020, within days of the World Health Organization pandemic declaration, the American Academy of Sleep Medicine (AASM) posted detailed guidance on mitigation strategies for sleep medicine practices (COVID-19 Resources).

This initial guidance has been previously reported in this publication (Sullivan S, Gurubhagavatula I. CHEST Physician 2020 May 8), and the guidance has been periodically updated during the pandemic. It was restructured in mid-2020 to include sections summarizing CDC recommendations germane for sleep practices; additional sleep medicine-specific guidance from the AASM COVID-19 Task Force (TF); and a frequently asked questions (FAQ) section. The last major update from the task force occurred on Jan. 18, 2021, though subsequent posts – especially related to recent CDC changes in masking guidelines – were made in May 2021. The purpose of this article is to summarize these updates and to call attention to areas of ongoing interest to sleep medicine. Notably, the AASM Task Force guidance is nonbinding and offered as a framework for considering best practices in this evolving situation, acknowledging the importance of weighing local factors, conditions, and regulations, as well as the interests of and risks to the patient, staff, and providers.

Key updates

Data on exposure and transmission risks specific to sleep medicine

Measures for reducing viral transmission have been central to managing the spread of the virus in clinical settings. In its last major update, the AASM TF noted that no known outbreaks of COVID-19 related to sleep center exposure have been reported. A perspective and data published in the Journal of the American Medical Association concluded that hospital transmission of the virus “in the setting of universal masking is likely rare, even during periods of high community prevalence.” It also concluded that hospital-based outbreaks are more likely to occur in small workrooms and during mealtime when staff are less adherent to masking and physical distancing (Richterman A, et al. JAMA. 2020;324[21]:2155-6). The TF elaborated on considerations to reduce transmission, which include not just telework and foundational infection control practices, but also broader workplace considerations such as optimizing ventilation, taking advantage of outdoor spaces (e.g., for breaks and eating), scheduling to reduce interactions between personnel from different teams, minimizing contact in meeting/break rooms, removing tables and chairs from lounge areas, and following CDC guidance for effective facility operations.

Vaccination

In the January update, the AASM COVID-19 TF stated that, “sleep facility leaders should encourage staff and patients to be vaccinated in accordance with CDC guidance.” The role of the sleep medicine community in encouraging healthy sleep habits before and after vaccination was emphasized, pointing to evidence linking sleep and immunity, specifically between sleep duration and vaccination response (Healthy sleep and immune response to COVID-19 vaccination. 2021 Jan.).

In an FAQ update from March 26, 2021, considering whether continued COVID-19 testing was needed following full vaccination, the AASM advised testing prior to potential aerosol-generating procedures should be made on the basis of a risk-benefit assessment by the sleep clinician. Several considerations were highlighted, including recent COVID-19 infection, vaccination status of contacts, local prevalence of newer variants, and whether individuals are receiving positive airway pressure therapy. The TF focused on the vigilance for residents and staff in long-term care facilities, which have been associated with a number of outbreaks.
 

Masking in the context of the COVID-19 vaccine

The most significant change in recommendations is the recent relaxation of masking guidance by the CDC in the setting of the approval and distribution of COVID-19 vaccinations. In May, the CDC stated that fully vaccinated individuals can resume activities without masking or physically distancing except in scenarios of travel and where required by laws, regulations, and local businesses, due to the efficacy of the vaccines, increasing evidence of reduced asymptomatic carriage and transmission after vaccination, and anticipated increased uptake of vaccination. However, the CDC also noted that these updates did not apply to health care facilities, where the recommendation remains that patients and visitors should continue to mask throughout their stay. Additionally, fully vaccinated health care workers should continue to practice infection control measures while working with patients. On May 14, the AASM TF provided a detailed FAQ acknowledging the CDC’s new guidance, emphasizing that masking guidance in health care facilities remains unchanged, and encouraging individuals to follow CDC guidance regarding vaccination, noting that emergence of newer variants continues to be monitored, and existing vaccines still appear to induce neutralizing antibodies even if to a somewhat lower degree. The situation for pediatric sleep centers has been highlighted in particular because the potential risk posed by newer variants to children remains under investigation, and children under age 12 are not approved for vaccination.
 

Important caveats to discussions around vaccination status are the lack of a centralized method to identify vaccinated individuals, the unknown duration of immunity, and reports of the use of fake vaccine cards. At this time, in health care settings, vaccination status should not exempt mask usage for any individual.
 

Sleep medicine care for those with COVID-19

Regarding the duration of isolation and precautions for adults with COVID-19, the TF highlighted the CDC’s symptom-based strategy, rather than test-based strategy, for ending isolation of these patients, availing them of sleep medicine services in person.

In line with the CDC guidance, this approach indicates that scheduling in-person care such as polysomnography for a COVID-19–positive patient may be appropriate at least 10 days after symptom onset (or after a positive test if the patient never developed symptoms); or at least 20 days after symptom onset if the illness was severe; or if at least 90 days have elapsed since symptom onset, consider preappointment COVID-19 screening. In the context of immunocompromised individuals, involvement from infectious disease specialists may be needed to help guide decisions.
 

Patient communications

For many, a repercussion of the pandemic has been delaying care or avoiding addressing medical issues, including sleep disorders. The AASM encouraged practices to consider communicating with patients that delaying needed care can increase health risks; COVID-19 transmission to patients in health care settings has been low; effective safety procedures are in place; and whether remote/telehealth services are available.

Disparities in care

In addition to the specific guidance above, there are ongoing concerns regarding disparities in care resulting from a variety of sources and becoming more evident during the pandemic. Complex factors, ranging from economic, geographic, contextual, occupational, and others contribute to disparities that health care systems – and sleep medicine - have not been able to adequately address (Jackson CL and Johnson DA. J Clin Sleep Med. 16[8]:1401-2). More specific differences may include Internet access, reduced access due to socioeconomic barriers, transportation limitations, medical mistrust, and membership in a medically vulnerable group such as children, the elderly, and those with high acuity needs. For example, in pediatric patients there exist few evidence-based alternatives and guidelines to in-lab testing and care, which may have negatively impacted access to needed sleep medicine services (Sullivan S et al. J Clin Sleep Med. 2021 Mar 1;17[3]:361-2).
 

Economics in the COVID-19 pandemic

The economic effects of COVID-19 on medical institutions and in sleep medicine is a story that continues to unfold. Reductions in patient visits and elective procedures, infection control measures limiting capacity, increased costs to maintain such measures, and variability of responses by payer and region are just a few of the issues. The Centers for Medicare & Medicaid Services has employed waivers to increased flexibility and promote safe and effective care including the use of telemedicine during the public health emergency, but the future of these waivers remains uncertain. Alarmingly, a sizeable portion of sleep practices reported financial solvency concerns related to the pandemic (Ramar K. J Clin Sleep Med. 2020;16[11]:1939-42).

Conclusion

As the COVID-19 pandemic and related public health guidance continues to evolve, sleep medicine practices continue to adapt. Vaccination, new variants, changes in mask guidance, new outbreaks around the globe, financial and staffing uncertainties, as well as addressing disparities in care and outcomes that may be augmented by the pandemic remain salient areas of ongoing development.

Dr. Lee is a Postdoctoral and Pediatric Pulmonary Fellow, Department of Pediatrics, Division of Pulmonary, Asthma, and Sleep Medicine, Stanford University School of Medicine; Dr. Sullivan is Clinical Professor, Department of Pediatrics, Division of Pulmonary, Asthma, and Sleep Medicine, and by courtesy, Division of Sleep Medicine, Department of Psychiatry, Stanford University School of Medicine, Palo Alto, CA.

Hormone replacement therapy and development of new asthma. By Dr. E. Hansen et al.



Sex and gender omic biomarkers in men and women with COPD: Considerations for precision medicine. By Dr. D. Demeo.



Pulmonary function and radiological features in survivors of critical covid-19: A 3-month prospective cohort. By Dr. F. Barbe et al.



Characteristics and prevalence of domestic and occupational inhalational exposures across interstitial lung diseases. By Dr. C. Lee et al.



Identification and remediation of environmental exposures in patients with interstitial lung disease: Evidence review and practical considerations. By Dr. M. Salisbury et al.



How we do it: Creating an organizational culture for the chest physician. By Dr. J. Stoller et al..



Proposed quality metrics for lung cancer screening programs: A national lung cancer roundtable project. By Dr. P. Mazzone et al.

Hormone replacement therapy and development of new asthma. By Dr. E. Hansen et al.



Sex and gender omic biomarkers in men and women with COPD: Considerations for precision medicine. By Dr. D. Demeo.



Pulmonary function and radiological features in survivors of critical covid-19: A 3-month prospective cohort. By Dr. F. Barbe et al.



Characteristics and prevalence of domestic and occupational inhalational exposures across interstitial lung diseases. By Dr. C. Lee et al.



Identification and remediation of environmental exposures in patients with interstitial lung disease: Evidence review and practical considerations. By Dr. M. Salisbury et al.



How we do it: Creating an organizational culture for the chest physician. By Dr. J. Stoller et al..



Proposed quality metrics for lung cancer screening programs: A national lung cancer roundtable project. By Dr. P. Mazzone et al.

Hormone replacement therapy and development of new asthma. By Dr. E. Hansen et al.



Sex and gender omic biomarkers in men and women with COPD: Considerations for precision medicine. By Dr. D. Demeo.



Pulmonary function and radiological features in survivors of critical covid-19: A 3-month prospective cohort. By Dr. F. Barbe et al.



Characteristics and prevalence of domestic and occupational inhalational exposures across interstitial lung diseases. By Dr. C. Lee et al.



Identification and remediation of environmental exposures in patients with interstitial lung disease: Evidence review and practical considerations. By Dr. M. Salisbury et al.



How we do it: Creating an organizational culture for the chest physician. By Dr. J. Stoller et al..



Proposed quality metrics for lung cancer screening programs: A national lung cancer roundtable project. By Dr. P. Mazzone et al.

The NetWorks Challenge 2021 is kicking off in July with a 25k to celebrate the Foundation’s 25th anniversary. This year, we’re asking each NetWork to participate in a physical challenge, virtually. Make your way to 25k by walking, running, biking – or any activity that suits you.

Through the challenge, you can engage in friendly competition while supporting the goals of the Foundation. This year, money raised will directly help us in addressing health disparities through our microgrants program and will support travel grants for doctors-in-training looking to attend CHEST 2021.

With your help, by participating in the NetWorks Challenge, we can fund grants that aim to lend a hand to those who need it the most. Expanding research capabilities, improving patient care, and giving access to medical equipment are just a few ways microgrants from the CHEST Foundation have been used in the past.

Salim Surani, MD, MSc, FCCP, is a long-time supporter of the NetWorks Challenge and the Foundation’s grants program. “Whatever the Foundation pays in terms of grants and awards not only impacts the recipient but also the community as a whole ... For me, it was a no-brainer to get involved in an organization that actually raises funding to support community, education, and research,” Dr. Surani said.

With your support, during the NetWorks Challenge, we can provide grants to more clinicians looking to make a difference in chest medicine.

Encourage your NetWork members to join you this summer in the race to 25k.

“When you work within the NetWorks and join together, and work along with the CHEST Foundation, the impact is much more powerful. I always believed that it is a privilege for us that we have the outlet at the CHEST Foundation to provide grants,” Dr. Surani said.

To learn more about this initiative and this year’s NetWorks Challenge, visit the CHEST Foundation’s website at https://foundation.chestnet.org/.

The NetWorks Challenge 2021 is kicking off in July with a 25k to celebrate the Foundation’s 25th anniversary. This year, we’re asking each NetWork to participate in a physical challenge, virtually. Make your way to 25k by walking, running, biking – or any activity that suits you.

Through the challenge, you can engage in friendly competition while supporting the goals of the Foundation. This year, money raised will directly help us in addressing health disparities through our microgrants program and will support travel grants for doctors-in-training looking to attend CHEST 2021.

With your help, by participating in the NetWorks Challenge, we can fund grants that aim to lend a hand to those who need it the most. Expanding research capabilities, improving patient care, and giving access to medical equipment are just a few ways microgrants from the CHEST Foundation have been used in the past.

Salim Surani, MD, MSc, FCCP, is a long-time supporter of the NetWorks Challenge and the Foundation’s grants program. “Whatever the Foundation pays in terms of grants and awards not only impacts the recipient but also the community as a whole ... For me, it was a no-brainer to get involved in an organization that actually raises funding to support community, education, and research,” Dr. Surani said.

With your support, during the NetWorks Challenge, we can provide grants to more clinicians looking to make a difference in chest medicine.

Encourage your NetWork members to join you this summer in the race to 25k.

“When you work within the NetWorks and join together, and work along with the CHEST Foundation, the impact is much more powerful. I always believed that it is a privilege for us that we have the outlet at the CHEST Foundation to provide grants,” Dr. Surani said.

To learn more about this initiative and this year’s NetWorks Challenge, visit the CHEST Foundation’s website at https://foundation.chestnet.org/.

The NetWorks Challenge 2021 is kicking off in July with a 25k to celebrate the Foundation’s 25th anniversary. This year, we’re asking each NetWork to participate in a physical challenge, virtually. Make your way to 25k by walking, running, biking – or any activity that suits you.

Through the challenge, you can engage in friendly competition while supporting the goals of the Foundation. This year, money raised will directly help us in addressing health disparities through our microgrants program and will support travel grants for doctors-in-training looking to attend CHEST 2021.

With your help, by participating in the NetWorks Challenge, we can fund grants that aim to lend a hand to those who need it the most. Expanding research capabilities, improving patient care, and giving access to medical equipment are just a few ways microgrants from the CHEST Foundation have been used in the past.

Salim Surani, MD, MSc, FCCP, is a long-time supporter of the NetWorks Challenge and the Foundation’s grants program. “Whatever the Foundation pays in terms of grants and awards not only impacts the recipient but also the community as a whole ... For me, it was a no-brainer to get involved in an organization that actually raises funding to support community, education, and research,” Dr. Surani said.

With your support, during the NetWorks Challenge, we can provide grants to more clinicians looking to make a difference in chest medicine.

Encourage your NetWork members to join you this summer in the race to 25k.

“When you work within the NetWorks and join together, and work along with the CHEST Foundation, the impact is much more powerful. I always believed that it is a privilege for us that we have the outlet at the CHEST Foundation to provide grants,” Dr. Surani said.

To learn more about this initiative and this year’s NetWorks Challenge, visit the CHEST Foundation’s website at https://foundation.chestnet.org/.

This year’s CHEST Annual Meeting will push the envelope of fun through various educational games and experiences for those attending on-site and online.

CHEST is supercharging the escape room experience with the expansion of two unique on-site escape scenarios to solve, First Contact and Shuttle Crash. In escape rooms, small teams work against the clock to solve a medical puzzle and unlock the final challenges. Those attending online can take a break and join the excitement with First Contact, a mission to Jupiter led by our space lieutenant, William Kelly, MD, FCCP, and faculty and staff game fleet. To build off the futuristic hands-on experiences, CHEST will be debuting intubation procedural simulations using state-of-the-art virtual reality technology.

If you prefer to join the fun using your mobile device, CHEST is releasing daily task-based missions that you can track and complete using your phone. These missions will include a variety of social activities designed around the conference halls, hotels, clinic, and your own home that are sure to get you moving and working as a team.

During the 4 days of the annual meeting, CHEST will also host an exclusive event called “Play With the Pros.” You can test your knowledge and play alongside annual meeting cochairs, Chris Carroll, MD, FCCP, and David Zielinski, MD, FCCP, for the chance to win a grand prize. As an added bonus, CHEST is offering daily prize drawings for players and social media recognition to those who top the leaderboards in the CHEST Player Hub. The Player Hub hosts more than 10 bite-sized mobile games and is available on demand with your CHEST ID.

Additionally, live game breaks hosted by our faculty between education sessions will give you the chance to unwind and play in real time with your peers and colleagues. On-site, CHEST invites you to shoot hoops, drive remote-controlled cars, and shuffle across the gameboard floors. From your couch or desk, you can tune in to test your knowledge in our livestreamed trivia or sign up for the chance to receive a trivia question phone call from our faculty, which is tied to a grand prize.

The opportunities to play and learn during CHEST Games are endless at CHEST 2021!

This year’s CHEST Annual Meeting will push the envelope of fun through various educational games and experiences for those attending on-site and online.

CHEST is supercharging the escape room experience with the expansion of two unique on-site escape scenarios to solve, First Contact and Shuttle Crash. In escape rooms, small teams work against the clock to solve a medical puzzle and unlock the final challenges. Those attending online can take a break and join the excitement with First Contact, a mission to Jupiter led by our space lieutenant, William Kelly, MD, FCCP, and faculty and staff game fleet. To build off the futuristic hands-on experiences, CHEST will be debuting intubation procedural simulations using state-of-the-art virtual reality technology.

If you prefer to join the fun using your mobile device, CHEST is releasing daily task-based missions that you can track and complete using your phone. These missions will include a variety of social activities designed around the conference halls, hotels, clinic, and your own home that are sure to get you moving and working as a team.

During the 4 days of the annual meeting, CHEST will also host an exclusive event called “Play With the Pros.” You can test your knowledge and play alongside annual meeting cochairs, Chris Carroll, MD, FCCP, and David Zielinski, MD, FCCP, for the chance to win a grand prize. As an added bonus, CHEST is offering daily prize drawings for players and social media recognition to those who top the leaderboards in the CHEST Player Hub. The Player Hub hosts more than 10 bite-sized mobile games and is available on demand with your CHEST ID.

Additionally, live game breaks hosted by our faculty between education sessions will give you the chance to unwind and play in real time with your peers and colleagues. On-site, CHEST invites you to shoot hoops, drive remote-controlled cars, and shuffle across the gameboard floors. From your couch or desk, you can tune in to test your knowledge in our livestreamed trivia or sign up for the chance to receive a trivia question phone call from our faculty, which is tied to a grand prize.

The opportunities to play and learn during CHEST Games are endless at CHEST 2021!

This year’s CHEST Annual Meeting will push the envelope of fun through various educational games and experiences for those attending on-site and online.

CHEST is supercharging the escape room experience with the expansion of two unique on-site escape scenarios to solve, First Contact and Shuttle Crash. In escape rooms, small teams work against the clock to solve a medical puzzle and unlock the final challenges. Those attending online can take a break and join the excitement with First Contact, a mission to Jupiter led by our space lieutenant, William Kelly, MD, FCCP, and faculty and staff game fleet. To build off the futuristic hands-on experiences, CHEST will be debuting intubation procedural simulations using state-of-the-art virtual reality technology.

If you prefer to join the fun using your mobile device, CHEST is releasing daily task-based missions that you can track and complete using your phone. These missions will include a variety of social activities designed around the conference halls, hotels, clinic, and your own home that are sure to get you moving and working as a team.

During the 4 days of the annual meeting, CHEST will also host an exclusive event called “Play With the Pros.” You can test your knowledge and play alongside annual meeting cochairs, Chris Carroll, MD, FCCP, and David Zielinski, MD, FCCP, for the chance to win a grand prize. As an added bonus, CHEST is offering daily prize drawings for players and social media recognition to those who top the leaderboards in the CHEST Player Hub. The Player Hub hosts more than 10 bite-sized mobile games and is available on demand with your CHEST ID.

Additionally, live game breaks hosted by our faculty between education sessions will give you the chance to unwind and play in real time with your peers and colleagues. On-site, CHEST invites you to shoot hoops, drive remote-controlled cars, and shuffle across the gameboard floors. From your couch or desk, you can tune in to test your knowledge in our livestreamed trivia or sign up for the chance to receive a trivia question phone call from our faculty, which is tied to a grand prize.

The opportunities to play and learn during CHEST Games are endless at CHEST 2021!

The CHEST Board of Regents met in mid-June for its first in-person meeting in more than a year. It served as a lovely reminder that not only are in-person meetings a more effective way to conduct the business of the College, but that the members of the board have really missed seeing each other without an intervening screen and webcam.

First on the agenda was a recap by the CHEST presidents of their recent strategic retreat. Most relevant to the organization was a recommendation that we revise the manner by which the CHEST strategic plan is set. If the last year has taught us anything, it is that planning for the future is essential, but we must also allow for flexibility when external forces change what the future holds. Accordingly, we will be replacing the former 5-year planning cycle with a more nimble annual review. From a member’s standpoint, this means that you will see more frequent revisions of those plans (Strategic Plan, American College of Chest Physicians).

Over the last year, the CHEST Foundation has sponsored a series of “listening tours,” which has allowed our members and leaders to hear from many of our patients who feel disenfranchised from the medical system because of struggles with communication, finances, and access, among other issues. The willingness of our patients to share their struggles with us has inspired the Foundation to try to make inroads into these, better navigating these barriers. In direct response to what we’ve heard, the team is designing programs to help our caregivers focus on the psychological, social, environmental, and personal factors that impact our patients’ ability to obtain the critical health care that all need and deserve.

Our ability to execute and deliver such programs is contingent on successful fundraising efforts. Ian Nathanson, president of the CHEST Foundation, reviewed fundraising progress with the board. Over these long months, donors, participants, and friends of the Foundation have participated in virtual events designed to foster engagement and comradery through this difficult time. This June, we held a virtual and in-person Belmont Stakes event that has shown that we can adapt to challenging times and that our membership is still incredibly supportive of the Foundation’s mission. Thank you to all of you who participated in or donated to the CHEST Foundation over the last year!

The last 18 months have had a marked impact on our ability to provide the live, interactive learning experiences for which CHEST is known, but efforts in the remote learning space have yielded impressive increases in both the number of remote learning opportunities and the breadth of our members who are using them. As one example, the number of CHEST podcast views quadrupled last year compared with 2019. Although CHEST reopened its headquarters for live learning opportunities this summer, and we are looking to move significantly back toward “business as usual” with CHEST 2021 in Orlando this October, we will also be carefully considering how best to incorporate the lessons learned in the remote offering space as the world reopens in the coming year.

Neil Freedman, chair of CHEST’s Health Advocacy and Policy Committee (HPAC), presented a review of the committee’s work since its inception just over 1 year ago. In addition to putting together a multi-society Technical Expert Panel on the use and coverage of noninvasive ventilation, HPAC worked with 18 other societies in drafting a response to the Agency for Healthcare Research and Quality’s draft on coverage for CPAP therapy for obstructive sleep apnea. For members interested in getting more involved in CHEST’s advocacy efforts, we are seeking self-nominations for members of several working groups (nominations to open soon); in addition, there will be sessions during CHEST 2021 focused on our advocacy efforts and how you can participate, as well as best practices in the advocacy space.

Several months ago, the Exeter Group was asked by the board to analyze how CHEST can expand our organizational efforts in diversity, equity, and inclusion (DEI). Representatives from the Exeter Group joined the meeting to provide board members with preliminary data. Limited interviews with both members and staff have begun to provide a picture of where CHEST has already made some progress in this space, and where our ongoing challenges and opportunities for improvement still exist; it is clear that there is a wide range of opinions on these complicated issues. As our consultants are only 1 month into this 6-month phase of the project, we expect a great deal more information to come, with a plan for ongoing surveys of and focus groups for our members; when you receive one of these requests, please make every effort to complete it as candidly as possible, regardless of your viewpoint. The consulting work will culminate with a final presentation to the board just before the annual meeting in the fall, with specific recommendations on organizational actions that will be used to implement a multiyear DEI plan.

The Governance Committee, represented by Stephanie Levine, made several recommendations to revision of the CHEST Foundations bylaws. Specifically, the new bylaws permit Trustees of the Foundation to be re-elected to positions on the board beyond the current 6-year maximum term after several years away from the position. The position of President-Designate of the Foundation will also be eliminated, allowing for a 2-year term for the President-Elect of the Foundation and a 2-year term for the President of the Foundation.

One of the main challenges for an organization of 19,000 people is to ensure that we can engage as many of our members as possible. The NetWorks structure has historically been the primary mechanism for members to pursue initial leadership opportunities within the College. CHEST Past-President Stephanie Levine previously established a working group to revisit NetWork structure in an effort to ensure ample opportunities for engagement within CHEST. The final agenda item at this board meeting was a discussion about restructuring the CHEST NetWorks to create mechanisms that will help us balance the needs of the College with the energy of the volunteers to maximize productivity and engagement of all parties. The plan would increase the number of leadership positions available within the NetWork structure. While the final nomenclature and distribution of NetWorks amongst the pillars has yet to be finalized, the board was supportive of this modification and expects implementation in the next 12 months, with details to be provided to the membership as they are fleshed out.

After a full day’s agenda, CHEST President Steve Simpson adjourned the board meeting. The Board of Regents will meet remotely in August (the summer call has always been a remote meeting) and again in Orlando in October.

The CHEST Board of Regents met in mid-June for its first in-person meeting in more than a year. It served as a lovely reminder that not only are in-person meetings a more effective way to conduct the business of the College, but that the members of the board have really missed seeing each other without an intervening screen and webcam.

First on the agenda was a recap by the CHEST presidents of their recent strategic retreat. Most relevant to the organization was a recommendation that we revise the manner by which the CHEST strategic plan is set. If the last year has taught us anything, it is that planning for the future is essential, but we must also allow for flexibility when external forces change what the future holds. Accordingly, we will be replacing the former 5-year planning cycle with a more nimble annual review. From a member’s standpoint, this means that you will see more frequent revisions of those plans (Strategic Plan, American College of Chest Physicians).

Over the last year, the CHEST Foundation has sponsored a series of “listening tours,” which has allowed our members and leaders to hear from many of our patients who feel disenfranchised from the medical system because of struggles with communication, finances, and access, among other issues. The willingness of our patients to share their struggles with us has inspired the Foundation to try to make inroads into these, better navigating these barriers. In direct response to what we’ve heard, the team is designing programs to help our caregivers focus on the psychological, social, environmental, and personal factors that impact our patients’ ability to obtain the critical health care that all need and deserve.

Our ability to execute and deliver such programs is contingent on successful fundraising efforts. Ian Nathanson, president of the CHEST Foundation, reviewed fundraising progress with the board. Over these long months, donors, participants, and friends of the Foundation have participated in virtual events designed to foster engagement and comradery through this difficult time. This June, we held a virtual and in-person Belmont Stakes event that has shown that we can adapt to challenging times and that our membership is still incredibly supportive of the Foundation’s mission. Thank you to all of you who participated in or donated to the CHEST Foundation over the last year!

The last 18 months have had a marked impact on our ability to provide the live, interactive learning experiences for which CHEST is known, but efforts in the remote learning space have yielded impressive increases in both the number of remote learning opportunities and the breadth of our members who are using them. As one example, the number of CHEST podcast views quadrupled last year compared with 2019. Although CHEST reopened its headquarters for live learning opportunities this summer, and we are looking to move significantly back toward “business as usual” with CHEST 2021 in Orlando this October, we will also be carefully considering how best to incorporate the lessons learned in the remote offering space as the world reopens in the coming year.

Neil Freedman, chair of CHEST’s Health Advocacy and Policy Committee (HPAC), presented a review of the committee’s work since its inception just over 1 year ago. In addition to putting together a multi-society Technical Expert Panel on the use and coverage of noninvasive ventilation, HPAC worked with 18 other societies in drafting a response to the Agency for Healthcare Research and Quality’s draft on coverage for CPAP therapy for obstructive sleep apnea. For members interested in getting more involved in CHEST’s advocacy efforts, we are seeking self-nominations for members of several working groups (nominations to open soon); in addition, there will be sessions during CHEST 2021 focused on our advocacy efforts and how you can participate, as well as best practices in the advocacy space.

Several months ago, the Exeter Group was asked by the board to analyze how CHEST can expand our organizational efforts in diversity, equity, and inclusion (DEI). Representatives from the Exeter Group joined the meeting to provide board members with preliminary data. Limited interviews with both members and staff have begun to provide a picture of where CHEST has already made some progress in this space, and where our ongoing challenges and opportunities for improvement still exist; it is clear that there is a wide range of opinions on these complicated issues. As our consultants are only 1 month into this 6-month phase of the project, we expect a great deal more information to come, with a plan for ongoing surveys of and focus groups for our members; when you receive one of these requests, please make every effort to complete it as candidly as possible, regardless of your viewpoint. The consulting work will culminate with a final presentation to the board just before the annual meeting in the fall, with specific recommendations on organizational actions that will be used to implement a multiyear DEI plan.

The Governance Committee, represented by Stephanie Levine, made several recommendations to revision of the CHEST Foundations bylaws. Specifically, the new bylaws permit Trustees of the Foundation to be re-elected to positions on the board beyond the current 6-year maximum term after several years away from the position. The position of President-Designate of the Foundation will also be eliminated, allowing for a 2-year term for the President-Elect of the Foundation and a 2-year term for the President of the Foundation.

One of the main challenges for an organization of 19,000 people is to ensure that we can engage as many of our members as possible. The NetWorks structure has historically been the primary mechanism for members to pursue initial leadership opportunities within the College. CHEST Past-President Stephanie Levine previously established a working group to revisit NetWork structure in an effort to ensure ample opportunities for engagement within CHEST. The final agenda item at this board meeting was a discussion about restructuring the CHEST NetWorks to create mechanisms that will help us balance the needs of the College with the energy of the volunteers to maximize productivity and engagement of all parties. The plan would increase the number of leadership positions available within the NetWork structure. While the final nomenclature and distribution of NetWorks amongst the pillars has yet to be finalized, the board was supportive of this modification and expects implementation in the next 12 months, with details to be provided to the membership as they are fleshed out.

After a full day’s agenda, CHEST President Steve Simpson adjourned the board meeting. The Board of Regents will meet remotely in August (the summer call has always been a remote meeting) and again in Orlando in October.

The CHEST Board of Regents met in mid-June for its first in-person meeting in more than a year. It served as a lovely reminder that not only are in-person meetings a more effective way to conduct the business of the College, but that the members of the board have really missed seeing each other without an intervening screen and webcam.

First on the agenda was a recap by the CHEST presidents of their recent strategic retreat. Most relevant to the organization was a recommendation that we revise the manner by which the CHEST strategic plan is set. If the last year has taught us anything, it is that planning for the future is essential, but we must also allow for flexibility when external forces change what the future holds. Accordingly, we will be replacing the former 5-year planning cycle with a more nimble annual review. From a member’s standpoint, this means that you will see more frequent revisions of those plans (Strategic Plan, American College of Chest Physicians).

Over the last year, the CHEST Foundation has sponsored a series of “listening tours,” which has allowed our members and leaders to hear from many of our patients who feel disenfranchised from the medical system because of struggles with communication, finances, and access, among other issues. The willingness of our patients to share their struggles with us has inspired the Foundation to try to make inroads into these, better navigating these barriers. In direct response to what we’ve heard, the team is designing programs to help our caregivers focus on the psychological, social, environmental, and personal factors that impact our patients’ ability to obtain the critical health care that all need and deserve.

Our ability to execute and deliver such programs is contingent on successful fundraising efforts. Ian Nathanson, president of the CHEST Foundation, reviewed fundraising progress with the board. Over these long months, donors, participants, and friends of the Foundation have participated in virtual events designed to foster engagement and comradery through this difficult time. This June, we held a virtual and in-person Belmont Stakes event that has shown that we can adapt to challenging times and that our membership is still incredibly supportive of the Foundation’s mission. Thank you to all of you who participated in or donated to the CHEST Foundation over the last year!

The last 18 months have had a marked impact on our ability to provide the live, interactive learning experiences for which CHEST is known, but efforts in the remote learning space have yielded impressive increases in both the number of remote learning opportunities and the breadth of our members who are using them. As one example, the number of CHEST podcast views quadrupled last year compared with 2019. Although CHEST reopened its headquarters for live learning opportunities this summer, and we are looking to move significantly back toward “business as usual” with CHEST 2021 in Orlando this October, we will also be carefully considering how best to incorporate the lessons learned in the remote offering space as the world reopens in the coming year.

Neil Freedman, chair of CHEST’s Health Advocacy and Policy Committee (HPAC), presented a review of the committee’s work since its inception just over 1 year ago. In addition to putting together a multi-society Technical Expert Panel on the use and coverage of noninvasive ventilation, HPAC worked with 18 other societies in drafting a response to the Agency for Healthcare Research and Quality’s draft on coverage for CPAP therapy for obstructive sleep apnea. For members interested in getting more involved in CHEST’s advocacy efforts, we are seeking self-nominations for members of several working groups (nominations to open soon); in addition, there will be sessions during CHEST 2021 focused on our advocacy efforts and how you can participate, as well as best practices in the advocacy space.

Several months ago, the Exeter Group was asked by the board to analyze how CHEST can expand our organizational efforts in diversity, equity, and inclusion (DEI). Representatives from the Exeter Group joined the meeting to provide board members with preliminary data. Limited interviews with both members and staff have begun to provide a picture of where CHEST has already made some progress in this space, and where our ongoing challenges and opportunities for improvement still exist; it is clear that there is a wide range of opinions on these complicated issues. As our consultants are only 1 month into this 6-month phase of the project, we expect a great deal more information to come, with a plan for ongoing surveys of and focus groups for our members; when you receive one of these requests, please make every effort to complete it as candidly as possible, regardless of your viewpoint. The consulting work will culminate with a final presentation to the board just before the annual meeting in the fall, with specific recommendations on organizational actions that will be used to implement a multiyear DEI plan.

The Governance Committee, represented by Stephanie Levine, made several recommendations to revision of the CHEST Foundations bylaws. Specifically, the new bylaws permit Trustees of the Foundation to be re-elected to positions on the board beyond the current 6-year maximum term after several years away from the position. The position of President-Designate of the Foundation will also be eliminated, allowing for a 2-year term for the President-Elect of the Foundation and a 2-year term for the President of the Foundation.

One of the main challenges for an organization of 19,000 people is to ensure that we can engage as many of our members as possible. The NetWorks structure has historically been the primary mechanism for members to pursue initial leadership opportunities within the College. CHEST Past-President Stephanie Levine previously established a working group to revisit NetWork structure in an effort to ensure ample opportunities for engagement within CHEST. The final agenda item at this board meeting was a discussion about restructuring the CHEST NetWorks to create mechanisms that will help us balance the needs of the College with the energy of the volunteers to maximize productivity and engagement of all parties. The plan would increase the number of leadership positions available within the NetWork structure. While the final nomenclature and distribution of NetWorks amongst the pillars has yet to be finalized, the board was supportive of this modification and expects implementation in the next 12 months, with details to be provided to the membership as they are fleshed out.

After a full day’s agenda, CHEST President Steve Simpson adjourned the board meeting. The Board of Regents will meet remotely in August (the summer call has always been a remote meeting) and again in Orlando in October.

Airways disorders

Eosinophils in COPD

Using peripheral blood eosinophilia (PBE) as a treatable biomarker of airway inflammation in patients with COPD has become an area of controversy in pulmonary medicine.

The proponents find a role for PBE testing in initiation and withdrawal of inhaled corticosteroids (ICS) and as a target for monoclonal antibodies in future studies.¹ Post hoc analyses showed that variable doses of ICS/LABA combination compared with LABA alone in COPD patients were associated with much higher exacerbation reduction in patients with eosinophils counts of ≥2% and magnitude of effect proportionally increased from 29% to 42% with increasing eosinophil count from ≥2% to ≥6% suggesting a dose-response relationship.² A post hoc analysis of the WISDOM trial showed increased risk of exacerbation after ICS discontinuation in COPD patients with high eosinophils (≥300 cells/mcL or ≥4%) while exacerbation risk was not increased in patients with low eosinophils (<150 cells/mcL or <2%).³

The opponents of eosinophil-guided therapy object that the level of evidence is weak as this is based on the post hoc analyses of randomized control trials on patients with increased exacerbation risk at baseline, which in itself is an independent predictor of future exacerbations.⁴ Some observational studies failed to find increased risk of exacerbation with higher eosinophil count while others found that higher eosinophil count was associated with increased survival and better quality of life.^5,6 Anti-eosinophilic biologics have failed to show consistent benefit in exacerbation reduction in COPD patients so far, despite showing a reduction in the PBE.^7-9

The GOLD COPD Guidelines support the use of ICS in patients with eosinophils >300 cells/mcL especially with a history of exacerbation and recommend against ICS in patients with eosinophils <100 cells/mcL.¹⁰

Farrukh Abbas, MD
Steering Committee Fellow-in-Training
Allen J. Blaivas, MD, FCCP
NetWork Chair
 

References

1. Wade RC and Wells JM. Chest. 2020;157(5):1073-5.

2. Pascoe S et al. The Lancet Respir Med. 2015;3(6):435-42.

3. Watz H et al. The Lancet Respir Med. 2016;4(5):390-8.

4. Criner GJ. Chest. 2020;157(5):1075-8.

5. Shin SH et al. Respir Res. 2018;19(1):134.

6. Casanova C et al. Eur Respir J. 2017;50(5):1701162.

7. Pavord ID et al. N Engl J Med. 2017;377(17):1613-29.

8. Criner GJ et al. N Engl J Med. 2019;381(11):1023-34.

9. Mycroft K et al. J Allergy Clin Immunol Pract. 2020 Sep;8(8):2565-74.

10. Global Initiative for Chronic Obstructive Lung Disease 2021 Report.
 

Clinical research

Long-COVID: COVID-19 disease beyond the pandemic

There are increasing reports of persistent multiorgan symptoms following COVID-19 infection.

In December 2020, the National Institute for Health and Care Excellence (NICE) developed guidelines, based primarily on expert opinion, to define and manage ongoing symptomatic COVID-19 (symptoms for 4-12 weeks after infection) and post-COVID syndrome (symptoms present for > 12 weeks without alternative explanation). Subsequently, the National Institutes of Health (NIH), released in February 2021 an initiative to study Post-Acute Sequelae of SARS-CoV2 infection (PASC). Symptoms can include, respiratory (cough, shortness of breath), cardiac (palpitations, chest pain), fatigue and physical limitations, and neurologic (depression, insomnia, cognitive impairment) (Lancet 2020 Dec 12;396[10266]:1861). The majority of patients with post-COVID syndrome have microbiological recovery (PCR negative), and often have radiological recovery. Risk factors include older age, female sex, and comorbidities (Raveendran AV. Diabetes Metab Syndr. 2021 May-June;15[3]:869-75).

Diagnosis and access to care pose significant challenges for post-COVID syndrome, and it is difficult to estimate exactly how many are affected – one report from Italy found that up to 87% of discharged hospitalized patients had persistent symptom(s) at 60 days (Carfi A. JAMA 2020 Aug;324[6]:603-5). Thus far, management recommendations include a multidisciplinary approach to evaluation, symptomatic treatment, organ specific treatment (for example, consideration of corticosteroids for persistent inflammatory interstitial lung disease) (Myall KJ. Ann Am Thorac Soc. 2021 May;8[5]:799-806), physical/occupational therapy, and psychological support. Many institutions have established, or are working to establish post-COVID clinics (Aging Clin Exp Res. 2020 Aug;32[8]:1613-20). Currently, the NIH is offering funding opportunities and there are many clinical trials across the world actively recruiting patients.

Ankita Agarwal, MD
Steering Committee Fellow-in-Training
Bharat Bajantri, MD
Steering Committee Member
Aravind Menon, MD
Steering Committee Fellow-in-Training
 

Critical care

Sedation practices in the ICU: Moving past the COVID-19 pandemic

The COVID-19 pandemic brought unprecedented change to critical care practice patterns, and sedation practices in the intensive care unit are no exception. In a large cohort analysis of over 2,000 adults with COVID-19 (Pun BT, et al. Lancet Respir Med. 2021;9[3]:239-50), 64% of patients received benzodiazepines (median of 7 days), and patients were deeply sedated. More than half of the patients were delirious, with benzodiazepine use associated with increased incidence of delirium. These observations represent a significant departure from well-established pre-COVID best-practices in sedation: light targets, daily sedation interruption, and avoiding continuous benzodiazepine infusions whenever possible (Girard TD, et al. Lancet; 2008;371[9607]:126-34; Fraser GL, et al. Crit Care Med;2013 Sep;41[9 Suppl 1]:S30-8; Riker RR, et al. JAMA;2009;301[5]:489-99).

As COVID-19 case counts begin to improve in many of our communities, we have the opportunity to refocus on best sedation practices and build on a growing body of recent evidence. The MENDS2 trial, completed pre-COVID-19, assigned mechanically ventilated patients with sepsis to either propofol or dexmedetomidine and showed no difference in delirium or coma in this cohort of lightly sedated patients (Hughes CG, et al. N Engl J Med. 2021;384[15]:1424-36). Furthering this point, Olsen et al. found no difference in outcomes when mechanically ventilated patients were randomized to no sedation vs light sedation (Olsen HT, et al. N Engl J Med; 2020;382[12]:1103-11).

While the evidence surrounding sedation strategies in the critically ill continues to grow, one thing is certain: promoting lighter sedation targets and reengaging in sedation-related best practices following the COVID-19 pandemic will continue to play a vital role in improving both short and long-term outcomes for our critically ill patients.

Casey Cable, MD, MSc
Steering Committee Member

Kyle Stinehart, MD
Steering Committee Member
 

Home mechanical ventilation

How to initiate a chronic respiratory failure clinic

Noninvasive ventilation (NIV) is an established treatment for chronic hypercapnic respiratory failure from neuromuscular disorders, COPD, obesity hypoventilation syndrome (OHS), and restrictive thoracic disorders. Previously, hospital admission was considered essential for setup of chronic NIV but with advances in the modes of ventilation and remote monitoring, hospital admission has become less justifiable, especially in countries with centralized medical systems and presence of centers of excellence for home ventilation (Van Den Biggelaar RJM, et al. Chest. 2020;158[6]:2493-2501); Duiverman ML, et al. Thorax. 2020;75:244-52). In the United States, where centralized health care is atypical, management of NIV has been disparate with no clear consensus on practice patterns. Thus, we hope to provide some guidance toward the establishment of such clinics in the U.S.
 

Prior to developing an NIV clinic, establishing a referral source from neuromuscular, rehabilitation/spinal cord injury, bariatric surgery, and COPD programs is important. After this, collaboration with a respiratory therapist through durable medical equipment is essential to building a robust care team. These companies are also important for assisting in remote monitoring, providing overnight pulse oximetry/CO₂ monitoring, mask fitting, and airway clearance. Clinicians are encouraged to develop protocols for initiation and titration of NIV and mouthpiece ventilation. Clinics should provide spirometry, maximal inspiratory pressure, transcutaneous CO₂, and/or blood gas testing. Additionally, in this patient population, wheelchair scales are necessary. Clinical workflow should include a review of NIV downloads, identify asynchronies and troubleshoot it in timely and reliable manner (Blouet S, et al. Int J Chron Obstruct Pulmon Dis. 2018;13:2577-86). Lastly, effort should be made for an adequate assessment of the home situation including layout of home along with family support utilizing social worker and palliative care team. Due to patient mobility, we encourage continued availability of telehealth for these patients.

In summary, strong clinical infrastructure, a robust care team, and an efficient, secure, reliable telemonitoring system are key to provide better care to this vulnerable patient population.

Ashima S. Sahni, MD, MBBS, FCCP
NetWork Member

Amen Sergew, MD
Steering Committee Member

Interstitial and diffuse lung disease

Treatment for pulmonary hypertension secondary to interstitial lung disease

The development of pulmonary hypertension (PH) in patients with interstitial lung disease (ILD) (PH-ILD) is associated with increased supplemental oxygen requirements, reduced functional status, and decreased survival (King CS, et al. Chest. 2020;158[4]:1651).

An inhaled formulation of treprostinil (Tyvaso) is the first treatment option approved by the FDA for patients with PH-ILD, including those with idiopathic pulmonary fibrosis, connective tissue disease-associated ILD, and combined pulmonary fibrosis and emphysema. Approval was based on results from the INCREASE trial (Waxman A, et al. N Engl J Med. 2021;384[4]:325), a phase III multicenter, randomized, double-blinded study comparing the inhaled formulation to placebo in 326 patients over a 16-week period. Participants in the treatment arm were given up to 12 breaths of the formulation per session, four times per day. Subjects treated with this inhaled formulation met the primary study endpoint, an increase in 6-minute walk distance (6MWD) from baseline to week 16, walking 21 m farther than placebo-treated control subjects. Furthermore, patients receiving the new formulation had a decrease in NT-proBNP levels (compared with increases in the placebo arm) and a reduction in clinical worsening (23% of inhalation formulation-treated vs. 33% of placebo-treated subjects). This formulation of treprostinil was well-tolerated with a safety profile consistent with common prostacyclin-related adverse events, including cough, headache, dyspnea, dizziness, nausea, fatigue, and diarrhea. Its approval will dramatically alter the ILD treatment landscape. It now necessitates the use of PH screening in this patient population. However, care will need to be exercised in appropriate patient selection for treatment, using the study inclusion and exclusion criteria as a starting point. Appropriate use of this formulation will hopefully help mitigate the negative outcomes impacting patients with PH-ILD.

Rebecca Anna Gersten, MD
Adrian Shifren, MD
Steering Committee Members

Airways disorders

Eosinophils in COPD

Using peripheral blood eosinophilia (PBE) as a treatable biomarker of airway inflammation in patients with COPD has become an area of controversy in pulmonary medicine.

The proponents find a role for PBE testing in initiation and withdrawal of inhaled corticosteroids (ICS) and as a target for monoclonal antibodies in future studies.¹ Post hoc analyses showed that variable doses of ICS/LABA combination compared with LABA alone in COPD patients were associated with much higher exacerbation reduction in patients with eosinophils counts of ≥2% and magnitude of effect proportionally increased from 29% to 42% with increasing eosinophil count from ≥2% to ≥6% suggesting a dose-response relationship.² A post hoc analysis of the WISDOM trial showed increased risk of exacerbation after ICS discontinuation in COPD patients with high eosinophils (≥300 cells/mcL or ≥4%) while exacerbation risk was not increased in patients with low eosinophils (<150 cells/mcL or <2%).³

The opponents of eosinophil-guided therapy object that the level of evidence is weak as this is based on the post hoc analyses of randomized control trials on patients with increased exacerbation risk at baseline, which in itself is an independent predictor of future exacerbations.⁴ Some observational studies failed to find increased risk of exacerbation with higher eosinophil count while others found that higher eosinophil count was associated with increased survival and better quality of life.^5,6 Anti-eosinophilic biologics have failed to show consistent benefit in exacerbation reduction in COPD patients so far, despite showing a reduction in the PBE.^7-9

The GOLD COPD Guidelines support the use of ICS in patients with eosinophils >300 cells/mcL especially with a history of exacerbation and recommend against ICS in patients with eosinophils <100 cells/mcL.¹⁰

Farrukh Abbas, MD
Steering Committee Fellow-in-Training
Allen J. Blaivas, MD, FCCP
NetWork Chair
 

References

1. Wade RC and Wells JM. Chest. 2020;157(5):1073-5.

2. Pascoe S et al. The Lancet Respir Med. 2015;3(6):435-42.

3. Watz H et al. The Lancet Respir Med. 2016;4(5):390-8.

4. Criner GJ. Chest. 2020;157(5):1075-8.

5. Shin SH et al. Respir Res. 2018;19(1):134.

6. Casanova C et al. Eur Respir J. 2017;50(5):1701162.

7. Pavord ID et al. N Engl J Med. 2017;377(17):1613-29.

8. Criner GJ et al. N Engl J Med. 2019;381(11):1023-34.

9. Mycroft K et al. J Allergy Clin Immunol Pract. 2020 Sep;8(8):2565-74.

10. Global Initiative for Chronic Obstructive Lung Disease 2021 Report.
 

Clinical research

Long-COVID: COVID-19 disease beyond the pandemic

There are increasing reports of persistent multiorgan symptoms following COVID-19 infection.

In December 2020, the National Institute for Health and Care Excellence (NICE) developed guidelines, based primarily on expert opinion, to define and manage ongoing symptomatic COVID-19 (symptoms for 4-12 weeks after infection) and post-COVID syndrome (symptoms present for > 12 weeks without alternative explanation). Subsequently, the National Institutes of Health (NIH), released in February 2021 an initiative to study Post-Acute Sequelae of SARS-CoV2 infection (PASC). Symptoms can include, respiratory (cough, shortness of breath), cardiac (palpitations, chest pain), fatigue and physical limitations, and neurologic (depression, insomnia, cognitive impairment) (Lancet 2020 Dec 12;396[10266]:1861). The majority of patients with post-COVID syndrome have microbiological recovery (PCR negative), and often have radiological recovery. Risk factors include older age, female sex, and comorbidities (Raveendran AV. Diabetes Metab Syndr. 2021 May-June;15[3]:869-75).

Diagnosis and access to care pose significant challenges for post-COVID syndrome, and it is difficult to estimate exactly how many are affected – one report from Italy found that up to 87% of discharged hospitalized patients had persistent symptom(s) at 60 days (Carfi A. JAMA 2020 Aug;324[6]:603-5). Thus far, management recommendations include a multidisciplinary approach to evaluation, symptomatic treatment, organ specific treatment (for example, consideration of corticosteroids for persistent inflammatory interstitial lung disease) (Myall KJ. Ann Am Thorac Soc. 2021 May;8[5]:799-806), physical/occupational therapy, and psychological support. Many institutions have established, or are working to establish post-COVID clinics (Aging Clin Exp Res. 2020 Aug;32[8]:1613-20). Currently, the NIH is offering funding opportunities and there are many clinical trials across the world actively recruiting patients.

Ankita Agarwal, MD
Steering Committee Fellow-in-Training
Bharat Bajantri, MD
Steering Committee Member
Aravind Menon, MD
Steering Committee Fellow-in-Training
 

Critical care

Sedation practices in the ICU: Moving past the COVID-19 pandemic

The COVID-19 pandemic brought unprecedented change to critical care practice patterns, and sedation practices in the intensive care unit are no exception. In a large cohort analysis of over 2,000 adults with COVID-19 (Pun BT, et al. Lancet Respir Med. 2021;9[3]:239-50), 64% of patients received benzodiazepines (median of 7 days), and patients were deeply sedated. More than half of the patients were delirious, with benzodiazepine use associated with increased incidence of delirium. These observations represent a significant departure from well-established pre-COVID best-practices in sedation: light targets, daily sedation interruption, and avoiding continuous benzodiazepine infusions whenever possible (Girard TD, et al. Lancet; 2008;371[9607]:126-34; Fraser GL, et al. Crit Care Med;2013 Sep;41[9 Suppl 1]:S30-8; Riker RR, et al. JAMA;2009;301[5]:489-99).

As COVID-19 case counts begin to improve in many of our communities, we have the opportunity to refocus on best sedation practices and build on a growing body of recent evidence. The MENDS2 trial, completed pre-COVID-19, assigned mechanically ventilated patients with sepsis to either propofol or dexmedetomidine and showed no difference in delirium or coma in this cohort of lightly sedated patients (Hughes CG, et al. N Engl J Med. 2021;384[15]:1424-36). Furthering this point, Olsen et al. found no difference in outcomes when mechanically ventilated patients were randomized to no sedation vs light sedation (Olsen HT, et al. N Engl J Med; 2020;382[12]:1103-11).

While the evidence surrounding sedation strategies in the critically ill continues to grow, one thing is certain: promoting lighter sedation targets and reengaging in sedation-related best practices following the COVID-19 pandemic will continue to play a vital role in improving both short and long-term outcomes for our critically ill patients.

Casey Cable, MD, MSc
Steering Committee Member

Kyle Stinehart, MD
Steering Committee Member
 

Home mechanical ventilation

How to initiate a chronic respiratory failure clinic

Noninvasive ventilation (NIV) is an established treatment for chronic hypercapnic respiratory failure from neuromuscular disorders, COPD, obesity hypoventilation syndrome (OHS), and restrictive thoracic disorders. Previously, hospital admission was considered essential for setup of chronic NIV but with advances in the modes of ventilation and remote monitoring, hospital admission has become less justifiable, especially in countries with centralized medical systems and presence of centers of excellence for home ventilation (Van Den Biggelaar RJM, et al. Chest. 2020;158[6]:2493-2501); Duiverman ML, et al. Thorax. 2020;75:244-52). In the United States, where centralized health care is atypical, management of NIV has been disparate with no clear consensus on practice patterns. Thus, we hope to provide some guidance toward the establishment of such clinics in the U.S.
 

Prior to developing an NIV clinic, establishing a referral source from neuromuscular, rehabilitation/spinal cord injury, bariatric surgery, and COPD programs is important. After this, collaboration with a respiratory therapist through durable medical equipment is essential to building a robust care team. These companies are also important for assisting in remote monitoring, providing overnight pulse oximetry/CO₂ monitoring, mask fitting, and airway clearance. Clinicians are encouraged to develop protocols for initiation and titration of NIV and mouthpiece ventilation. Clinics should provide spirometry, maximal inspiratory pressure, transcutaneous CO₂, and/or blood gas testing. Additionally, in this patient population, wheelchair scales are necessary. Clinical workflow should include a review of NIV downloads, identify asynchronies and troubleshoot it in timely and reliable manner (Blouet S, et al. Int J Chron Obstruct Pulmon Dis. 2018;13:2577-86). Lastly, effort should be made for an adequate assessment of the home situation including layout of home along with family support utilizing social worker and palliative care team. Due to patient mobility, we encourage continued availability of telehealth for these patients.

In summary, strong clinical infrastructure, a robust care team, and an efficient, secure, reliable telemonitoring system are key to provide better care to this vulnerable patient population.

Ashima S. Sahni, MD, MBBS, FCCP
NetWork Member

Amen Sergew, MD
Steering Committee Member

Interstitial and diffuse lung disease

Treatment for pulmonary hypertension secondary to interstitial lung disease

The development of pulmonary hypertension (PH) in patients with interstitial lung disease (ILD) (PH-ILD) is associated with increased supplemental oxygen requirements, reduced functional status, and decreased survival (King CS, et al. Chest. 2020;158[4]:1651).

An inhaled formulation of treprostinil (Tyvaso) is the first treatment option approved by the FDA for patients with PH-ILD, including those with idiopathic pulmonary fibrosis, connective tissue disease-associated ILD, and combined pulmonary fibrosis and emphysema. Approval was based on results from the INCREASE trial (Waxman A, et al. N Engl J Med. 2021;384[4]:325), a phase III multicenter, randomized, double-blinded study comparing the inhaled formulation to placebo in 326 patients over a 16-week period. Participants in the treatment arm were given up to 12 breaths of the formulation per session, four times per day. Subjects treated with this inhaled formulation met the primary study endpoint, an increase in 6-minute walk distance (6MWD) from baseline to week 16, walking 21 m farther than placebo-treated control subjects. Furthermore, patients receiving the new formulation had a decrease in NT-proBNP levels (compared with increases in the placebo arm) and a reduction in clinical worsening (23% of inhalation formulation-treated vs. 33% of placebo-treated subjects). This formulation of treprostinil was well-tolerated with a safety profile consistent with common prostacyclin-related adverse events, including cough, headache, dyspnea, dizziness, nausea, fatigue, and diarrhea. Its approval will dramatically alter the ILD treatment landscape. It now necessitates the use of PH screening in this patient population. However, care will need to be exercised in appropriate patient selection for treatment, using the study inclusion and exclusion criteria as a starting point. Appropriate use of this formulation will hopefully help mitigate the negative outcomes impacting patients with PH-ILD.

Rebecca Anna Gersten, MD
Adrian Shifren, MD
Steering Committee Members

Airways disorders

Eosinophils in COPD

Using peripheral blood eosinophilia (PBE) as a treatable biomarker of airway inflammation in patients with COPD has become an area of controversy in pulmonary medicine.

The proponents find a role for PBE testing in initiation and withdrawal of inhaled corticosteroids (ICS) and as a target for monoclonal antibodies in future studies.¹ Post hoc analyses showed that variable doses of ICS/LABA combination compared with LABA alone in COPD patients were associated with much higher exacerbation reduction in patients with eosinophils counts of ≥2% and magnitude of effect proportionally increased from 29% to 42% with increasing eosinophil count from ≥2% to ≥6% suggesting a dose-response relationship.² A post hoc analysis of the WISDOM trial showed increased risk of exacerbation after ICS discontinuation in COPD patients with high eosinophils (≥300 cells/mcL or ≥4%) while exacerbation risk was not increased in patients with low eosinophils (<150 cells/mcL or <2%).³

The opponents of eosinophil-guided therapy object that the level of evidence is weak as this is based on the post hoc analyses of randomized control trials on patients with increased exacerbation risk at baseline, which in itself is an independent predictor of future exacerbations.⁴ Some observational studies failed to find increased risk of exacerbation with higher eosinophil count while others found that higher eosinophil count was associated with increased survival and better quality of life.^5,6 Anti-eosinophilic biologics have failed to show consistent benefit in exacerbation reduction in COPD patients so far, despite showing a reduction in the PBE.^7-9

The GOLD COPD Guidelines support the use of ICS in patients with eosinophils >300 cells/mcL especially with a history of exacerbation and recommend against ICS in patients with eosinophils <100 cells/mcL.¹⁰

Farrukh Abbas, MD
Steering Committee Fellow-in-Training
Allen J. Blaivas, MD, FCCP
NetWork Chair
 

References

1. Wade RC and Wells JM. Chest. 2020;157(5):1073-5.

2. Pascoe S et al. The Lancet Respir Med. 2015;3(6):435-42.

3. Watz H et al. The Lancet Respir Med. 2016;4(5):390-8.

4. Criner GJ. Chest. 2020;157(5):1075-8.

5. Shin SH et al. Respir Res. 2018;19(1):134.

6. Casanova C et al. Eur Respir J. 2017;50(5):1701162.

7. Pavord ID et al. N Engl J Med. 2017;377(17):1613-29.

8. Criner GJ et al. N Engl J Med. 2019;381(11):1023-34.

9. Mycroft K et al. J Allergy Clin Immunol Pract. 2020 Sep;8(8):2565-74.

10. Global Initiative for Chronic Obstructive Lung Disease 2021 Report.
 

Clinical research

Long-COVID: COVID-19 disease beyond the pandemic

There are increasing reports of persistent multiorgan symptoms following COVID-19 infection.

In December 2020, the National Institute for Health and Care Excellence (NICE) developed guidelines, based primarily on expert opinion, to define and manage ongoing symptomatic COVID-19 (symptoms for 4-12 weeks after infection) and post-COVID syndrome (symptoms present for > 12 weeks without alternative explanation). Subsequently, the National Institutes of Health (NIH), released in February 2021 an initiative to study Post-Acute Sequelae of SARS-CoV2 infection (PASC). Symptoms can include, respiratory (cough, shortness of breath), cardiac (palpitations, chest pain), fatigue and physical limitations, and neurologic (depression, insomnia, cognitive impairment) (Lancet 2020 Dec 12;396[10266]:1861). The majority of patients with post-COVID syndrome have microbiological recovery (PCR negative), and often have radiological recovery. Risk factors include older age, female sex, and comorbidities (Raveendran AV. Diabetes Metab Syndr. 2021 May-June;15[3]:869-75).

Diagnosis and access to care pose significant challenges for post-COVID syndrome, and it is difficult to estimate exactly how many are affected – one report from Italy found that up to 87% of discharged hospitalized patients had persistent symptom(s) at 60 days (Carfi A. JAMA 2020 Aug;324[6]:603-5). Thus far, management recommendations include a multidisciplinary approach to evaluation, symptomatic treatment, organ specific treatment (for example, consideration of corticosteroids for persistent inflammatory interstitial lung disease) (Myall KJ. Ann Am Thorac Soc. 2021 May;8[5]:799-806), physical/occupational therapy, and psychological support. Many institutions have established, or are working to establish post-COVID clinics (Aging Clin Exp Res. 2020 Aug;32[8]:1613-20). Currently, the NIH is offering funding opportunities and there are many clinical trials across the world actively recruiting patients.

Ankita Agarwal, MD
Steering Committee Fellow-in-Training
Bharat Bajantri, MD
Steering Committee Member
Aravind Menon, MD
Steering Committee Fellow-in-Training
 

Critical care

Sedation practices in the ICU: Moving past the COVID-19 pandemic

The COVID-19 pandemic brought unprecedented change to critical care practice patterns, and sedation practices in the intensive care unit are no exception. In a large cohort analysis of over 2,000 adults with COVID-19 (Pun BT, et al. Lancet Respir Med. 2021;9[3]:239-50), 64% of patients received benzodiazepines (median of 7 days), and patients were deeply sedated. More than half of the patients were delirious, with benzodiazepine use associated with increased incidence of delirium. These observations represent a significant departure from well-established pre-COVID best-practices in sedation: light targets, daily sedation interruption, and avoiding continuous benzodiazepine infusions whenever possible (Girard TD, et al. Lancet; 2008;371[9607]:126-34; Fraser GL, et al. Crit Care Med;2013 Sep;41[9 Suppl 1]:S30-8; Riker RR, et al. JAMA;2009;301[5]:489-99).

As COVID-19 case counts begin to improve in many of our communities, we have the opportunity to refocus on best sedation practices and build on a growing body of recent evidence. The MENDS2 trial, completed pre-COVID-19, assigned mechanically ventilated patients with sepsis to either propofol or dexmedetomidine and showed no difference in delirium or coma in this cohort of lightly sedated patients (Hughes CG, et al. N Engl J Med. 2021;384[15]:1424-36). Furthering this point, Olsen et al. found no difference in outcomes when mechanically ventilated patients were randomized to no sedation vs light sedation (Olsen HT, et al. N Engl J Med; 2020;382[12]:1103-11).

While the evidence surrounding sedation strategies in the critically ill continues to grow, one thing is certain: promoting lighter sedation targets and reengaging in sedation-related best practices following the COVID-19 pandemic will continue to play a vital role in improving both short and long-term outcomes for our critically ill patients.

Casey Cable, MD, MSc
Steering Committee Member

Kyle Stinehart, MD
Steering Committee Member
 

Home mechanical ventilation

How to initiate a chronic respiratory failure clinic

Noninvasive ventilation (NIV) is an established treatment for chronic hypercapnic respiratory failure from neuromuscular disorders, COPD, obesity hypoventilation syndrome (OHS), and restrictive thoracic disorders. Previously, hospital admission was considered essential for setup of chronic NIV but with advances in the modes of ventilation and remote monitoring, hospital admission has become less justifiable, especially in countries with centralized medical systems and presence of centers of excellence for home ventilation (Van Den Biggelaar RJM, et al. Chest. 2020;158[6]:2493-2501); Duiverman ML, et al. Thorax. 2020;75:244-52). In the United States, where centralized health care is atypical, management of NIV has been disparate with no clear consensus on practice patterns. Thus, we hope to provide some guidance toward the establishment of such clinics in the U.S.
 

Prior to developing an NIV clinic, establishing a referral source from neuromuscular, rehabilitation/spinal cord injury, bariatric surgery, and COPD programs is important. After this, collaboration with a respiratory therapist through durable medical equipment is essential to building a robust care team. These companies are also important for assisting in remote monitoring, providing overnight pulse oximetry/CO₂ monitoring, mask fitting, and airway clearance. Clinicians are encouraged to develop protocols for initiation and titration of NIV and mouthpiece ventilation. Clinics should provide spirometry, maximal inspiratory pressure, transcutaneous CO₂, and/or blood gas testing. Additionally, in this patient population, wheelchair scales are necessary. Clinical workflow should include a review of NIV downloads, identify asynchronies and troubleshoot it in timely and reliable manner (Blouet S, et al. Int J Chron Obstruct Pulmon Dis. 2018;13:2577-86). Lastly, effort should be made for an adequate assessment of the home situation including layout of home along with family support utilizing social worker and palliative care team. Due to patient mobility, we encourage continued availability of telehealth for these patients.

In summary, strong clinical infrastructure, a robust care team, and an efficient, secure, reliable telemonitoring system are key to provide better care to this vulnerable patient population.

Ashima S. Sahni, MD, MBBS, FCCP
NetWork Member

Amen Sergew, MD
Steering Committee Member

Interstitial and diffuse lung disease

Treatment for pulmonary hypertension secondary to interstitial lung disease

The development of pulmonary hypertension (PH) in patients with interstitial lung disease (ILD) (PH-ILD) is associated with increased supplemental oxygen requirements, reduced functional status, and decreased survival (King CS, et al. Chest. 2020;158[4]:1651).

An inhaled formulation of treprostinil (Tyvaso) is the first treatment option approved by the FDA for patients with PH-ILD, including those with idiopathic pulmonary fibrosis, connective tissue disease-associated ILD, and combined pulmonary fibrosis and emphysema. Approval was based on results from the INCREASE trial (Waxman A, et al. N Engl J Med. 2021;384[4]:325), a phase III multicenter, randomized, double-blinded study comparing the inhaled formulation to placebo in 326 patients over a 16-week period. Participants in the treatment arm were given up to 12 breaths of the formulation per session, four times per day. Subjects treated with this inhaled formulation met the primary study endpoint, an increase in 6-minute walk distance (6MWD) from baseline to week 16, walking 21 m farther than placebo-treated control subjects. Furthermore, patients receiving the new formulation had a decrease in NT-proBNP levels (compared with increases in the placebo arm) and a reduction in clinical worsening (23% of inhalation formulation-treated vs. 33% of placebo-treated subjects). This formulation of treprostinil was well-tolerated with a safety profile consistent with common prostacyclin-related adverse events, including cough, headache, dyspnea, dizziness, nausea, fatigue, and diarrhea. Its approval will dramatically alter the ILD treatment landscape. It now necessitates the use of PH screening in this patient population. However, care will need to be exercised in appropriate patient selection for treatment, using the study inclusion and exclusion criteria as a starting point. Appropriate use of this formulation will hopefully help mitigate the negative outcomes impacting patients with PH-ILD.

Rebecca Anna Gersten, MD
Adrian Shifren, MD
Steering Committee Members

Telemedicine has been proposed as a solution for an array of health care access problems over decades of gradual growth. The vast ramping up of telemedicine during the COVID-19 pandemic greatly expanded the evidence of its feasibility and what appears to be its inevitable incorporation into models of care, according to an update at the Health Policy and Advocacy Conference (HPAC) sponsored by the American College of Chest Physicians.

“The cat is out of the bag,” said Jaspal Singh, MD, FCCP, professor of medicine, Atrium Health, Charlotte, N.C. Due to changes in access and reimbursement to telemedicine driven by the pandemic, he said, “we now have permission to explore new models of care.”

Prior to February 2020, telemedicine was crawling forward at a leisurely pace, according to Dr. Singh. After March 2020, it broke into a run due to enormous demand and met by a rapid response from the U.S. Congress. The first of four legislative bills that directly or indirectly supported telemedicine was passed on March 6.

The Centers for Medicare and Medicaid Services (CMS) responded in kind, making modifications in a number of rules that removed obstacles to telehealth. One modification on April 6, for example, removed the requirement for a preexisting relationship between the clinician and patient, Dr. Singh said. The CMS also subsequently modified reimbursement policies in order to make telemedicine more tenable for physicians.

Given the risk of contagion from face-to-face encounters, telemedicine in the early days of the pandemic was not just attractive but the only practical and safe approach to medical care in many circumstances. Physicians and patients were anxious for health care that did not require in-office visits even though many critical issues for telemedicine, including its relative effectiveness, had not yet been fully evaluated.

Much has been learned regarding the feasibility and acceptability of telemedicine during the pandemic, but Dr. Singh noted that quality of care relative to in-person visits remains weakly supported for most indications. Indeed, he outlined a sizable list of incompletely resolved issues, including optimal payment models, management of privacy concerns, and how to balance advantages to disadvantages.

For patients and physicians, the strengths of telemedicine include greater convenience made possible by the elimination of travel and waiting rooms. For the health care system, it can include less infrastructure and overhead. For many physicians, telemedicine might be perceived as more efficient.

On the other hand, some patients might feel that a clinical encounter is incomplete without a physical examination even when the physician does not feel the physical examination is needed, according to Dr. Singh. He cited a survey suggesting nearly half of patients expressed concern about a lack of connection to health care providers following a virtual visit.

In the same 2020 National Poll on Healthy Aging 2020 survey conducted by the University of Michigan, 67% of respondents reported that the quality of care was not as good as that provided by in-patient visits, and 24% expressed concern about privacy. However, at the time the poll was taken in May 2020, experience with telemedicine among many of the respondents may have been limited. As telemedicine is integrated into routine care, perceptions might change as experience increases.

A distinction between telemedicine in routine care and telemedicine as a strategy to respond to a pandemic is important, Dr. Singh indicated. Dr. Singh was the lead author for a position paper on telemedicine for the diagnosis and treatment of sleep disorders from the American Academy of Sleep Medicine 5 years ago (J Clin Sleep Med. 2015;11:1187-98), but he acknowledged that models of care might differ when responding to abnormal surges in health care demand.

The surge in demand for COVID-19–related care engendered numerous innovative solutions. As examples, Dr. Singh recounted how a virtual hospital was created at his own institution. In a published study, 1,477 patients diagnosed with COVID19 over a 6-week period remained at home and received care in a virtual observation unit (VCU) or a virtual acute care unit (VACU) (Ann Intern Med. 2020;174:192-9). Only a small percentage required eventual hospital admission. In the VACU, patients were able to receive advanced care, including IV fluids and some form of respiratory support .

It is unclear how the COVID-19 pandemic will change telemedicine. Now, with declining cases of the infection, telemedicine is back to a walk after the sprint required during the height of the pandemic, according to Dr. Singh. However, Dr. Singh thinks many physicians and patients will have a different perception of telemedicine after the widespread exposure to this type of care.

In terms of the relative role of in-patient and virtual visits across indications, “we do not know how this will play out, but we will probably end up toggling between the two,” Dr. Singh said.

This is an area that is being followed closely by the CHEST Health Policy and Advocacy Committee, according to Kathleen Sarmiento, MD, FCCP, director, VISN 21 Sleep Clinical Resource Hub for the San Francisco VA Health Care System. A member of that Committee and moderator of the session in which Dr. Singh spoke, Dr. Sarmiento called the effort to bring permanent coverage of telehealth services “the shared responsibility of every medical society engaged in advocacy.”

However, she cautioned that there might be intended and unintended consequences from telehealth that require analysis to develop policies that are in the best interests of effective care. She said, the “ACCP [CHEST], along with its sister societies, does have a role in supporting the evaluation of the impact of these changes on both patients and providers in the fields of pulmonary medicine, critical care, and sleep medicine.”

Dr. Singh reports a financial relationship with AstraZeneca. Dr. Sarmiento reports no relevant financial relationships.

Telemedicine has been proposed as a solution for an array of health care access problems over decades of gradual growth. The vast ramping up of telemedicine during the COVID-19 pandemic greatly expanded the evidence of its feasibility and what appears to be its inevitable incorporation into models of care, according to an update at the Health Policy and Advocacy Conference (HPAC) sponsored by the American College of Chest Physicians.

“The cat is out of the bag,” said Jaspal Singh, MD, FCCP, professor of medicine, Atrium Health, Charlotte, N.C. Due to changes in access and reimbursement to telemedicine driven by the pandemic, he said, “we now have permission to explore new models of care.”

Prior to February 2020, telemedicine was crawling forward at a leisurely pace, according to Dr. Singh. After March 2020, it broke into a run due to enormous demand and met by a rapid response from the U.S. Congress. The first of four legislative bills that directly or indirectly supported telemedicine was passed on March 6.

The Centers for Medicare and Medicaid Services (CMS) responded in kind, making modifications in a number of rules that removed obstacles to telehealth. One modification on April 6, for example, removed the requirement for a preexisting relationship between the clinician and patient, Dr. Singh said. The CMS also subsequently modified reimbursement policies in order to make telemedicine more tenable for physicians.

Given the risk of contagion from face-to-face encounters, telemedicine in the early days of the pandemic was not just attractive but the only practical and safe approach to medical care in many circumstances. Physicians and patients were anxious for health care that did not require in-office visits even though many critical issues for telemedicine, including its relative effectiveness, had not yet been fully evaluated.

Much has been learned regarding the feasibility and acceptability of telemedicine during the pandemic, but Dr. Singh noted that quality of care relative to in-person visits remains weakly supported for most indications. Indeed, he outlined a sizable list of incompletely resolved issues, including optimal payment models, management of privacy concerns, and how to balance advantages to disadvantages.

For patients and physicians, the strengths of telemedicine include greater convenience made possible by the elimination of travel and waiting rooms. For the health care system, it can include less infrastructure and overhead. For many physicians, telemedicine might be perceived as more efficient.

On the other hand, some patients might feel that a clinical encounter is incomplete without a physical examination even when the physician does not feel the physical examination is needed, according to Dr. Singh. He cited a survey suggesting nearly half of patients expressed concern about a lack of connection to health care providers following a virtual visit.

In the same 2020 National Poll on Healthy Aging 2020 survey conducted by the University of Michigan, 67% of respondents reported that the quality of care was not as good as that provided by in-patient visits, and 24% expressed concern about privacy. However, at the time the poll was taken in May 2020, experience with telemedicine among many of the respondents may have been limited. As telemedicine is integrated into routine care, perceptions might change as experience increases.

A distinction between telemedicine in routine care and telemedicine as a strategy to respond to a pandemic is important, Dr. Singh indicated. Dr. Singh was the lead author for a position paper on telemedicine for the diagnosis and treatment of sleep disorders from the American Academy of Sleep Medicine 5 years ago (J Clin Sleep Med. 2015;11:1187-98), but he acknowledged that models of care might differ when responding to abnormal surges in health care demand.

The surge in demand for COVID-19–related care engendered numerous innovative solutions. As examples, Dr. Singh recounted how a virtual hospital was created at his own institution. In a published study, 1,477 patients diagnosed with COVID19 over a 6-week period remained at home and received care in a virtual observation unit (VCU) or a virtual acute care unit (VACU) (Ann Intern Med. 2020;174:192-9). Only a small percentage required eventual hospital admission. In the VACU, patients were able to receive advanced care, including IV fluids and some form of respiratory support .

It is unclear how the COVID-19 pandemic will change telemedicine. Now, with declining cases of the infection, telemedicine is back to a walk after the sprint required during the height of the pandemic, according to Dr. Singh. However, Dr. Singh thinks many physicians and patients will have a different perception of telemedicine after the widespread exposure to this type of care.

In terms of the relative role of in-patient and virtual visits across indications, “we do not know how this will play out, but we will probably end up toggling between the two,” Dr. Singh said.

This is an area that is being followed closely by the CHEST Health Policy and Advocacy Committee, according to Kathleen Sarmiento, MD, FCCP, director, VISN 21 Sleep Clinical Resource Hub for the San Francisco VA Health Care System. A member of that Committee and moderator of the session in which Dr. Singh spoke, Dr. Sarmiento called the effort to bring permanent coverage of telehealth services “the shared responsibility of every medical society engaged in advocacy.”

However, she cautioned that there might be intended and unintended consequences from telehealth that require analysis to develop policies that are in the best interests of effective care. She said, the “ACCP [CHEST], along with its sister societies, does have a role in supporting the evaluation of the impact of these changes on both patients and providers in the fields of pulmonary medicine, critical care, and sleep medicine.”

Dr. Singh reports a financial relationship with AstraZeneca. Dr. Sarmiento reports no relevant financial relationships.

Telemedicine has been proposed as a solution for an array of health care access problems over decades of gradual growth. The vast ramping up of telemedicine during the COVID-19 pandemic greatly expanded the evidence of its feasibility and what appears to be its inevitable incorporation into models of care, according to an update at the Health Policy and Advocacy Conference (HPAC) sponsored by the American College of Chest Physicians.

“The cat is out of the bag,” said Jaspal Singh, MD, FCCP, professor of medicine, Atrium Health, Charlotte, N.C. Due to changes in access and reimbursement to telemedicine driven by the pandemic, he said, “we now have permission to explore new models of care.”

Prior to February 2020, telemedicine was crawling forward at a leisurely pace, according to Dr. Singh. After March 2020, it broke into a run due to enormous demand and met by a rapid response from the U.S. Congress. The first of four legislative bills that directly or indirectly supported telemedicine was passed on March 6.

The Centers for Medicare and Medicaid Services (CMS) responded in kind, making modifications in a number of rules that removed obstacles to telehealth. One modification on April 6, for example, removed the requirement for a preexisting relationship between the clinician and patient, Dr. Singh said. The CMS also subsequently modified reimbursement policies in order to make telemedicine more tenable for physicians.

Given the risk of contagion from face-to-face encounters, telemedicine in the early days of the pandemic was not just attractive but the only practical and safe approach to medical care in many circumstances. Physicians and patients were anxious for health care that did not require in-office visits even though many critical issues for telemedicine, including its relative effectiveness, had not yet been fully evaluated.

Much has been learned regarding the feasibility and acceptability of telemedicine during the pandemic, but Dr. Singh noted that quality of care relative to in-person visits remains weakly supported for most indications. Indeed, he outlined a sizable list of incompletely resolved issues, including optimal payment models, management of privacy concerns, and how to balance advantages to disadvantages.

For patients and physicians, the strengths of telemedicine include greater convenience made possible by the elimination of travel and waiting rooms. For the health care system, it can include less infrastructure and overhead. For many physicians, telemedicine might be perceived as more efficient.

On the other hand, some patients might feel that a clinical encounter is incomplete without a physical examination even when the physician does not feel the physical examination is needed, according to Dr. Singh. He cited a survey suggesting nearly half of patients expressed concern about a lack of connection to health care providers following a virtual visit.

In the same 2020 National Poll on Healthy Aging 2020 survey conducted by the University of Michigan, 67% of respondents reported that the quality of care was not as good as that provided by in-patient visits, and 24% expressed concern about privacy. However, at the time the poll was taken in May 2020, experience with telemedicine among many of the respondents may have been limited. As telemedicine is integrated into routine care, perceptions might change as experience increases.

A distinction between telemedicine in routine care and telemedicine as a strategy to respond to a pandemic is important, Dr. Singh indicated. Dr. Singh was the lead author for a position paper on telemedicine for the diagnosis and treatment of sleep disorders from the American Academy of Sleep Medicine 5 years ago (J Clin Sleep Med. 2015;11:1187-98), but he acknowledged that models of care might differ when responding to abnormal surges in health care demand.

The surge in demand for COVID-19–related care engendered numerous innovative solutions. As examples, Dr. Singh recounted how a virtual hospital was created at his own institution. In a published study, 1,477 patients diagnosed with COVID19 over a 6-week period remained at home and received care in a virtual observation unit (VCU) or a virtual acute care unit (VACU) (Ann Intern Med. 2020;174:192-9). Only a small percentage required eventual hospital admission. In the VACU, patients were able to receive advanced care, including IV fluids and some form of respiratory support .

It is unclear how the COVID-19 pandemic will change telemedicine. Now, with declining cases of the infection, telemedicine is back to a walk after the sprint required during the height of the pandemic, according to Dr. Singh. However, Dr. Singh thinks many physicians and patients will have a different perception of telemedicine after the widespread exposure to this type of care.

In terms of the relative role of in-patient and virtual visits across indications, “we do not know how this will play out, but we will probably end up toggling between the two,” Dr. Singh said.

This is an area that is being followed closely by the CHEST Health Policy and Advocacy Committee, according to Kathleen Sarmiento, MD, FCCP, director, VISN 21 Sleep Clinical Resource Hub for the San Francisco VA Health Care System. A member of that Committee and moderator of the session in which Dr. Singh spoke, Dr. Sarmiento called the effort to bring permanent coverage of telehealth services “the shared responsibility of every medical society engaged in advocacy.”

However, she cautioned that there might be intended and unintended consequences from telehealth that require analysis to develop policies that are in the best interests of effective care. She said, the “ACCP [CHEST], along with its sister societies, does have a role in supporting the evaluation of the impact of these changes on both patients and providers in the fields of pulmonary medicine, critical care, and sleep medicine.”

Dr. Singh reports a financial relationship with AstraZeneca. Dr. Sarmiento reports no relevant financial relationships.

Simultaneous pancreas-kidney transplants are increasingly performed in the United States in people with type 2 diabetes who also have chronic kidney disease, with outcomes similar to those of people with type 1 diabetes.

Traditionally, recipients of pancreas transplants have been people with type 1 diabetes who also have either chronic kidney disease (CKD) or hypoglycemic unawareness. The former group could receive either a simultaneous pancreas-kidney or a pancreas after kidney transplant, while the latter – if they have normal kidney function – would be eligible for a pancreas transplant alone.

But increasingly in recent years, patients with type 2 diabetes and CKD have been receiving simultaneous pancreas-kidney transplants, with similar success rates to those of people with type 1 diabetes.

Such candidates are typically sufficiently fit, not morbidly obese, and taking insulin regardless of their C-peptide status, said Jon S. Odorico, MD, professor of surgery and director of pancreas and islet transplantation at the University of Wisconsin–Madison Transplant Program.

“One might ask: Is it a crazy idea to do a pancreas transplant for patients with type 2 diabetes? Based on the known mechanisms of hyperglycemia in these patients, it might seem so,” he said, noting that while individuals with type 2 diabetes usually have insulin resistance, many also have relative or absolute deficiency of insulin production.

“So by replacing beta-cell mass, pancreas transplantation addresses this beta-cell defect mechanism,” he explained when discussing the topic during a symposium held June 26 at the virtual American Diabetes Association (ADA) 81st Scientific Sessions.

Arguments in favor of simultaneous pancreas-kidney transplant in people with type 2 diabetes and CKD include the fact that type 2 diabetes is the leading cause of kidney disease in the United States – roughly 50-60% of candidates on the kidney transplant waiting list also have type 2 diabetes – and that kidney transplant alone tends to worsen diabetes control due to the required immunosuppression.

Moreover, due to a 2014 allocation policy change that separates simultaneous pancreas-kidney from kidney transplant–alone donor organs, waiting times are shorter for the former, and kidney quality is generally better than for kidney transplant alone, unless a living kidney donor is available.

And, Dr. Odorico added, “adding a pancreas to a kidney transplant does not appear to jeopardize patient survival or kidney graft survival in appropriately selected patients with diabetes.” However, he also noted that because type 2 diabetes is so heterogeneous, ideal candidates for simultaneous pancreas-kidney transplant are not yet clear.

Currently, people with type 2 diabetes account for about 20% of those receiving simultaneous pancreas-kidney transplants and about 50% of pancreas after kidney transplants. Few pancreas transplants alone are performed in type 2 diabetes because those individuals rarely experience severe life-threatening hypoglycemia, Dr. Odorico explained.
 

Criteria have shifted over time, C-peptide removed in 2019

In an interview, symposium moderator Peter G. Stock, MD, PhD, surgical director of the Kidney and Pancreas Transplant Program at the University of California, San Francisco, said he agreed that “it’s a surprising trend. It doesn’t make intuitive sense. In type 1 diabetes, it makes sense to replace the beta cells. But type 2 is due to a whole cluster of etiologies ... The view in the public domain is that it’s not due to the lack of insulin but problems with insulin resistance and obesity. So it doesn’t make a whole lot of sense to give you more insulin if it’s a receptor problem.”

But Dr. Stock noted that because in the past diabetes type wasn’t always rigorously assessed using C-peptide and antibody testing, which most centers measure today, “a number of transplants were done in people who turned out to have type 2. Our perception is that everybody who has type 2 is obese, but that’s not true anymore.”

Once it became apparent that some patients with type 2 diabetes who received pancreas transplants seemed to be doing well, the pancreas transplantation committee of the United Network for Organ Sharing (UNOS) established general criteria for the procedure in people with diabetes. They had to be taking insulin and have a C-peptide value of 2 ng/mL or below or taking insulin with a C-peptide greater than 2 ng/mL and a body mass index less than or equal to the maximum allowable BMI (28 kg/m² at the time).

Dr. Stock, who chaired that committee from 2005 to 2007, said: “We thought it was risky to offer a scarce pool of donor pancreases to people with type 2 when we had people with type 1 who we know will benefit from it. So initially, the committee decided to limit pancreas transplantation to those with type 2 who have fairly low insulin requirements and BMIs that are more in the range of people with type 1. And lo and behold the results were comparable.”

Subsequent to Dr. Stock’s tenure as chair, the UNOS committee decided that the BMI and C-peptide criteria for simultaneous pancreas-kidney were no longer scientifically justifiable and were potentially discriminatory both to minority populations with type 2 diabetes and people with type 1 diabetes who have a high BMI, so in 2019, they removed them.

Individual transplant centers must follow UNOS rules, but they can also add their own criteria. Some don’t perform simultaneous pancreas-kidney transplants in people with type 2 diabetes at all.

At Dr. Odorico’s center, which began doing so in 2012, patients with type 2 diabetes account for nearly 40% of all simultaneous pancreas-kidney transplants. Indications there include age 20-60 years, insulin dependent with requirements less than 1 unit/kg/day, CKD stage 3-5, predialysis or on dialysis, and BMI <33 kg/m².

“They are highly selected and a fairly fit group of patients,” Dr. Odorico noted.

Those who don’t meet all the requirements for simultaneous pancreas-kidney transplants may still be eligible for kidney transplant alone, from either a living or deceased donor, he said.

Dr. Stock’s criteria at UCSF are even more stringent for both BMI and insulin requirements.

SPK outcomes similar for type 1 and type 2 diabetes: Emerging data

Data to guide this area are accumulating slowly. Thus far, all studies have been retrospective and have used variable definitions for diabetes type and for graft failure. However, they’re fairly consistent in showing similar outcomes by diabetes type and little impact of C-peptide level on patient survival or survival of either kidney or pancreas graft, particularly after adjustment for confounding factors between the two types.

In a study from Dr. Odorico’s center of 284 type 1 and 39 type 2 diabetes patients undergoing simultaneous pancreas-kidney transplant between 2006 and 2017, pretransplant BMI and insulin requirements did not affect patient or graft survival in either type. There was a suggestion of greater risk for post-transplant diabetes with very high pretransplant insulin requirements (>75 units/day) but the numbers were too small to be definitive.  

“It’s clear we will be doing more pancreas transplants in the future in this group of patients, and it’s ripe for further investigation,” Dr. Odorico concluded.
 

Beta cells for all?

Dr. Stock added one more aspect. While of course whole-organ transplantation is limited by the shortage of human donors, stem cell–derived beta cells could potentially produce an unlimited supply. Both Dr. Stock and Dr. Odorico are working on different approaches to this.

“We’re really close,” he said, noting, “the data we get for people with type 2 diabetes undergoing solid organ pancreas transplant could also be applied to cellular therapy ... We need to get a better understanding of which patients will benefit. The data we have so far are very promising.”

Dr. Odorico is scientific founder, stock equity holder, scientific advisory board chair, and a prior grant support recipient from Regenerative Medical Solutions. He has reported receiving clinical trial support from Veloxis Pharmaceuticals, CareDx, Natera, and Vertex Pharmaceuticals. Dr. Stock has reported being on the scientific advisory board of Encellin and receives funding from the California Institute of Regenerative Medicine and National Institutes of Health.

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

Simultaneous pancreas-kidney transplants are increasingly performed in the United States in people with type 2 diabetes who also have chronic kidney disease, with outcomes similar to those of people with type 1 diabetes.

Traditionally, recipients of pancreas transplants have been people with type 1 diabetes who also have either chronic kidney disease (CKD) or hypoglycemic unawareness. The former group could receive either a simultaneous pancreas-kidney or a pancreas after kidney transplant, while the latter – if they have normal kidney function – would be eligible for a pancreas transplant alone.

But increasingly in recent years, patients with type 2 diabetes and CKD have been receiving simultaneous pancreas-kidney transplants, with similar success rates to those of people with type 1 diabetes.

Such candidates are typically sufficiently fit, not morbidly obese, and taking insulin regardless of their C-peptide status, said Jon S. Odorico, MD, professor of surgery and director of pancreas and islet transplantation at the University of Wisconsin–Madison Transplant Program.

“One might ask: Is it a crazy idea to do a pancreas transplant for patients with type 2 diabetes? Based on the known mechanisms of hyperglycemia in these patients, it might seem so,” he said, noting that while individuals with type 2 diabetes usually have insulin resistance, many also have relative or absolute deficiency of insulin production.

“So by replacing beta-cell mass, pancreas transplantation addresses this beta-cell defect mechanism,” he explained when discussing the topic during a symposium held June 26 at the virtual American Diabetes Association (ADA) 81st Scientific Sessions.

Arguments in favor of simultaneous pancreas-kidney transplant in people with type 2 diabetes and CKD include the fact that type 2 diabetes is the leading cause of kidney disease in the United States – roughly 50-60% of candidates on the kidney transplant waiting list also have type 2 diabetes – and that kidney transplant alone tends to worsen diabetes control due to the required immunosuppression.

Moreover, due to a 2014 allocation policy change that separates simultaneous pancreas-kidney from kidney transplant–alone donor organs, waiting times are shorter for the former, and kidney quality is generally better than for kidney transplant alone, unless a living kidney donor is available.

And, Dr. Odorico added, “adding a pancreas to a kidney transplant does not appear to jeopardize patient survival or kidney graft survival in appropriately selected patients with diabetes.” However, he also noted that because type 2 diabetes is so heterogeneous, ideal candidates for simultaneous pancreas-kidney transplant are not yet clear.

Currently, people with type 2 diabetes account for about 20% of those receiving simultaneous pancreas-kidney transplants and about 50% of pancreas after kidney transplants. Few pancreas transplants alone are performed in type 2 diabetes because those individuals rarely experience severe life-threatening hypoglycemia, Dr. Odorico explained.
 

Criteria have shifted over time, C-peptide removed in 2019

In an interview, symposium moderator Peter G. Stock, MD, PhD, surgical director of the Kidney and Pancreas Transplant Program at the University of California, San Francisco, said he agreed that “it’s a surprising trend. It doesn’t make intuitive sense. In type 1 diabetes, it makes sense to replace the beta cells. But type 2 is due to a whole cluster of etiologies ... The view in the public domain is that it’s not due to the lack of insulin but problems with insulin resistance and obesity. So it doesn’t make a whole lot of sense to give you more insulin if it’s a receptor problem.”

But Dr. Stock noted that because in the past diabetes type wasn’t always rigorously assessed using C-peptide and antibody testing, which most centers measure today, “a number of transplants were done in people who turned out to have type 2. Our perception is that everybody who has type 2 is obese, but that’s not true anymore.”

Once it became apparent that some patients with type 2 diabetes who received pancreas transplants seemed to be doing well, the pancreas transplantation committee of the United Network for Organ Sharing (UNOS) established general criteria for the procedure in people with diabetes. They had to be taking insulin and have a C-peptide value of 2 ng/mL or below or taking insulin with a C-peptide greater than 2 ng/mL and a body mass index less than or equal to the maximum allowable BMI (28 kg/m² at the time).

Dr. Stock, who chaired that committee from 2005 to 2007, said: “We thought it was risky to offer a scarce pool of donor pancreases to people with type 2 when we had people with type 1 who we know will benefit from it. So initially, the committee decided to limit pancreas transplantation to those with type 2 who have fairly low insulin requirements and BMIs that are more in the range of people with type 1. And lo and behold the results were comparable.”

Subsequent to Dr. Stock’s tenure as chair, the UNOS committee decided that the BMI and C-peptide criteria for simultaneous pancreas-kidney were no longer scientifically justifiable and were potentially discriminatory both to minority populations with type 2 diabetes and people with type 1 diabetes who have a high BMI, so in 2019, they removed them.

Individual transplant centers must follow UNOS rules, but they can also add their own criteria. Some don’t perform simultaneous pancreas-kidney transplants in people with type 2 diabetes at all.

At Dr. Odorico’s center, which began doing so in 2012, patients with type 2 diabetes account for nearly 40% of all simultaneous pancreas-kidney transplants. Indications there include age 20-60 years, insulin dependent with requirements less than 1 unit/kg/day, CKD stage 3-5, predialysis or on dialysis, and BMI <33 kg/m².

“They are highly selected and a fairly fit group of patients,” Dr. Odorico noted.

Those who don’t meet all the requirements for simultaneous pancreas-kidney transplants may still be eligible for kidney transplant alone, from either a living or deceased donor, he said.

Dr. Stock’s criteria at UCSF are even more stringent for both BMI and insulin requirements.

SPK outcomes similar for type 1 and type 2 diabetes: Emerging data

Data to guide this area are accumulating slowly. Thus far, all studies have been retrospective and have used variable definitions for diabetes type and for graft failure. However, they’re fairly consistent in showing similar outcomes by diabetes type and little impact of C-peptide level on patient survival or survival of either kidney or pancreas graft, particularly after adjustment for confounding factors between the two types.

In a study from Dr. Odorico’s center of 284 type 1 and 39 type 2 diabetes patients undergoing simultaneous pancreas-kidney transplant between 2006 and 2017, pretransplant BMI and insulin requirements did not affect patient or graft survival in either type. There was a suggestion of greater risk for post-transplant diabetes with very high pretransplant insulin requirements (>75 units/day) but the numbers were too small to be definitive.  

“It’s clear we will be doing more pancreas transplants in the future in this group of patients, and it’s ripe for further investigation,” Dr. Odorico concluded.
 

Beta cells for all?

Dr. Stock added one more aspect. While of course whole-organ transplantation is limited by the shortage of human donors, stem cell–derived beta cells could potentially produce an unlimited supply. Both Dr. Stock and Dr. Odorico are working on different approaches to this.

“We’re really close,” he said, noting, “the data we get for people with type 2 diabetes undergoing solid organ pancreas transplant could also be applied to cellular therapy ... We need to get a better understanding of which patients will benefit. The data we have so far are very promising.”

Dr. Odorico is scientific founder, stock equity holder, scientific advisory board chair, and a prior grant support recipient from Regenerative Medical Solutions. He has reported receiving clinical trial support from Veloxis Pharmaceuticals, CareDx, Natera, and Vertex Pharmaceuticals. Dr. Stock has reported being on the scientific advisory board of Encellin and receives funding from the California Institute of Regenerative Medicine and National Institutes of Health.

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

Simultaneous pancreas-kidney transplants are increasingly performed in the United States in people with type 2 diabetes who also have chronic kidney disease, with outcomes similar to those of people with type 1 diabetes.

Traditionally, recipients of pancreas transplants have been people with type 1 diabetes who also have either chronic kidney disease (CKD) or hypoglycemic unawareness. The former group could receive either a simultaneous pancreas-kidney or a pancreas after kidney transplant, while the latter – if they have normal kidney function – would be eligible for a pancreas transplant alone.

But increasingly in recent years, patients with type 2 diabetes and CKD have been receiving simultaneous pancreas-kidney transplants, with similar success rates to those of people with type 1 diabetes.

Such candidates are typically sufficiently fit, not morbidly obese, and taking insulin regardless of their C-peptide status, said Jon S. Odorico, MD, professor of surgery and director of pancreas and islet transplantation at the University of Wisconsin–Madison Transplant Program.

“One might ask: Is it a crazy idea to do a pancreas transplant for patients with type 2 diabetes? Based on the known mechanisms of hyperglycemia in these patients, it might seem so,” he said, noting that while individuals with type 2 diabetes usually have insulin resistance, many also have relative or absolute deficiency of insulin production.

“So by replacing beta-cell mass, pancreas transplantation addresses this beta-cell defect mechanism,” he explained when discussing the topic during a symposium held June 26 at the virtual American Diabetes Association (ADA) 81st Scientific Sessions.

Arguments in favor of simultaneous pancreas-kidney transplant in people with type 2 diabetes and CKD include the fact that type 2 diabetes is the leading cause of kidney disease in the United States – roughly 50-60% of candidates on the kidney transplant waiting list also have type 2 diabetes – and that kidney transplant alone tends to worsen diabetes control due to the required immunosuppression.

Moreover, due to a 2014 allocation policy change that separates simultaneous pancreas-kidney from kidney transplant–alone donor organs, waiting times are shorter for the former, and kidney quality is generally better than for kidney transplant alone, unless a living kidney donor is available.

And, Dr. Odorico added, “adding a pancreas to a kidney transplant does not appear to jeopardize patient survival or kidney graft survival in appropriately selected patients with diabetes.” However, he also noted that because type 2 diabetes is so heterogeneous, ideal candidates for simultaneous pancreas-kidney transplant are not yet clear.

Currently, people with type 2 diabetes account for about 20% of those receiving simultaneous pancreas-kidney transplants and about 50% of pancreas after kidney transplants. Few pancreas transplants alone are performed in type 2 diabetes because those individuals rarely experience severe life-threatening hypoglycemia, Dr. Odorico explained.
 

Criteria have shifted over time, C-peptide removed in 2019

In an interview, symposium moderator Peter G. Stock, MD, PhD, surgical director of the Kidney and Pancreas Transplant Program at the University of California, San Francisco, said he agreed that “it’s a surprising trend. It doesn’t make intuitive sense. In type 1 diabetes, it makes sense to replace the beta cells. But type 2 is due to a whole cluster of etiologies ... The view in the public domain is that it’s not due to the lack of insulin but problems with insulin resistance and obesity. So it doesn’t make a whole lot of sense to give you more insulin if it’s a receptor problem.”

But Dr. Stock noted that because in the past diabetes type wasn’t always rigorously assessed using C-peptide and antibody testing, which most centers measure today, “a number of transplants were done in people who turned out to have type 2. Our perception is that everybody who has type 2 is obese, but that’s not true anymore.”

Once it became apparent that some patients with type 2 diabetes who received pancreas transplants seemed to be doing well, the pancreas transplantation committee of the United Network for Organ Sharing (UNOS) established general criteria for the procedure in people with diabetes. They had to be taking insulin and have a C-peptide value of 2 ng/mL or below or taking insulin with a C-peptide greater than 2 ng/mL and a body mass index less than or equal to the maximum allowable BMI (28 kg/m² at the time).

Dr. Stock, who chaired that committee from 2005 to 2007, said: “We thought it was risky to offer a scarce pool of donor pancreases to people with type 2 when we had people with type 1 who we know will benefit from it. So initially, the committee decided to limit pancreas transplantation to those with type 2 who have fairly low insulin requirements and BMIs that are more in the range of people with type 1. And lo and behold the results were comparable.”

Subsequent to Dr. Stock’s tenure as chair, the UNOS committee decided that the BMI and C-peptide criteria for simultaneous pancreas-kidney were no longer scientifically justifiable and were potentially discriminatory both to minority populations with type 2 diabetes and people with type 1 diabetes who have a high BMI, so in 2019, they removed them.

Individual transplant centers must follow UNOS rules, but they can also add their own criteria. Some don’t perform simultaneous pancreas-kidney transplants in people with type 2 diabetes at all.

At Dr. Odorico’s center, which began doing so in 2012, patients with type 2 diabetes account for nearly 40% of all simultaneous pancreas-kidney transplants. Indications there include age 20-60 years, insulin dependent with requirements less than 1 unit/kg/day, CKD stage 3-5, predialysis or on dialysis, and BMI <33 kg/m².

“They are highly selected and a fairly fit group of patients,” Dr. Odorico noted.

Those who don’t meet all the requirements for simultaneous pancreas-kidney transplants may still be eligible for kidney transplant alone, from either a living or deceased donor, he said.

Dr. Stock’s criteria at UCSF are even more stringent for both BMI and insulin requirements.

SPK outcomes similar for type 1 and type 2 diabetes: Emerging data

Data to guide this area are accumulating slowly. Thus far, all studies have been retrospective and have used variable definitions for diabetes type and for graft failure. However, they’re fairly consistent in showing similar outcomes by diabetes type and little impact of C-peptide level on patient survival or survival of either kidney or pancreas graft, particularly after adjustment for confounding factors between the two types.

In a study from Dr. Odorico’s center of 284 type 1 and 39 type 2 diabetes patients undergoing simultaneous pancreas-kidney transplant between 2006 and 2017, pretransplant BMI and insulin requirements did not affect patient or graft survival in either type. There was a suggestion of greater risk for post-transplant diabetes with very high pretransplant insulin requirements (>75 units/day) but the numbers were too small to be definitive.  

“It’s clear we will be doing more pancreas transplants in the future in this group of patients, and it’s ripe for further investigation,” Dr. Odorico concluded.
 

Beta cells for all?

Dr. Stock added one more aspect. While of course whole-organ transplantation is limited by the shortage of human donors, stem cell–derived beta cells could potentially produce an unlimited supply. Both Dr. Stock and Dr. Odorico are working on different approaches to this.

“We’re really close,” he said, noting, “the data we get for people with type 2 diabetes undergoing solid organ pancreas transplant could also be applied to cellular therapy ... We need to get a better understanding of which patients will benefit. The data we have so far are very promising.”

Dr. Odorico is scientific founder, stock equity holder, scientific advisory board chair, and a prior grant support recipient from Regenerative Medical Solutions. He has reported receiving clinical trial support from Veloxis Pharmaceuticals, CareDx, Natera, and Vertex Pharmaceuticals. Dr. Stock has reported being on the scientific advisory board of Encellin and receives funding from the California Institute of Regenerative Medicine and National Institutes of Health.

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