Service members with posttraumatic stress disorder and other mental health conditions may eventually have expanded access to service dogs through legislation recently signed into law by President Joseph R. Biden.

supersizer/E+

The Puppies Assisting Wounded Servicemembers (PAWS) for Veterans Therapy Act (HR 1448) orders the Department of Veterans Affairs to begin a pilot program that over the course of 5 years will examine the utility and effectiveness of service dogs for improving the mental health of military veterans.

The legislation does not set a specific start date for the pilot program, but Rory Diamond, CEO of K9s for Warriors, a nonprofit organization based in Ponte Vedra, Fla., noted that K9s for Warriors and other organizations will be pushing the VA to start in 2022.

“We commend the White House for supporting this bill as a critical step in combating veteran suicide, and we’re confident in the path ahead for service dogs ultimately becoming a covered VA benefit to veterans with PTSD,” Mr. Diamond said in a statement provided to this news organization.

“For servicemembers relying on task-trained service dogs for PTSD, the HR 1448 is a giant leap towards supporting veterans and their service dogs in an equitable way,” Canine Companions, a national nonprofit organization that trains and provides service dogs, said in its own statement.

“It might mean the difference between having a veteran who won’t be here tomorrow and having one that will,” the group added.
 

Invisible wounds of war

In another statement, Bill McCabe, legislative affairs director at the Enlisted Association, said that “now, more than ever, veterans suffering from invisible wounds of war need access to trained service dogs, which have been scientifically proven to help alleviate symptoms of posttraumatic stress,” as well as traumatic brain injuries (TBIs) and military sexual trauma.

“We thank President Biden for recognizing veterans need every possible option when seeking mental health treatments, and look forward to working with the Department of Veterans Affairs to implement this important program,” Mr. McCabe said.

A recent VA report showed that in 2014, 40% of veterans had mental health conditions such as PTSD and substance use. An average of 20 veterans per day died by suicide that year.

Veterans with problems regarding mobility, hearing, and sight, as well as some mental health problems, have been eligible to have costs of veterinary care for service dogs paid by the VA, although the VA has not paid for the training of the animals.

The PAWS Act, which was bipartisan legislation introduced by U.S. Senators Thom Tillis (R-N.C.), Kyrsten Sinema (D-Ariz.), Kevin Cramer (R-N.D.), and Dianne Feinstein (D-Calif.), aims to expand eligibility to those with any mental health problems.

For at least a decade, various service dog and veterans’ organizations have pushed to have the VA expand the service dog benefit. This new law is a “first step,” said Mr. Diamond. “We had to kick open the door,” he said, adding that “the VA has essentially said no for almost 15 years.”

Mr. Diamond noted that there is “overwhelming” evidence showing that service dogs improve quality of life and reduce distress for veterans with PTSD and other diagnoses.
 

‘No excuse’

Results from a VA study showed that suicidal ideation was reduced in veterans who were paired with service dogs, compared with veterans paired with emotional support dogs. The study, which was made public in March, found no reduction in overall disability, according to a report by Military.com.

K9s for Warriors cites numerous other studies, published in peer-reviewed journals, that have shown that service dogs reduce PTSD symptoms, especially hypervigilance.

“There really is no excuse not to have the VA engaged in helping veterans suffering from posttraumatic stress who are extremely high risk of suicide to get a lifesaving service dog,” Mr. Diamond said.

His organization has paired 700 veterans suffering from TBI, PTSD, or military sexual trauma with a service dog. The organization provides a 3-week training program for the veteran and his or her dog.

Although about 200 of the graduates have been eligible to receive coverage from the VA for veterinary care for the dogs, it requires a lot of paperwork, and the criteria for who can be certified to receive that benefit are somewhat vague, Mr. Diamond noted.

Under current policy, the dog and veteran must have successfully completed a training program offered by an organization accredited by Assistance Dogs International or the International Guide Dog Federation. The VA does not pay for the training or the dog – which at K9s for Warriors costs about $25,000.

The new pilot program will enable eligible veterans to receive dog training instruction from accredited nonprofit service dog training organizations, and it will give them the opportunity to adopt a dog that they actively assisted in training.

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

Service members with posttraumatic stress disorder and other mental health conditions may eventually have expanded access to service dogs through legislation recently signed into law by President Joseph R. Biden.

supersizer/E+

The Puppies Assisting Wounded Servicemembers (PAWS) for Veterans Therapy Act (HR 1448) orders the Department of Veterans Affairs to begin a pilot program that over the course of 5 years will examine the utility and effectiveness of service dogs for improving the mental health of military veterans.

The legislation does not set a specific start date for the pilot program, but Rory Diamond, CEO of K9s for Warriors, a nonprofit organization based in Ponte Vedra, Fla., noted that K9s for Warriors and other organizations will be pushing the VA to start in 2022.

“We commend the White House for supporting this bill as a critical step in combating veteran suicide, and we’re confident in the path ahead for service dogs ultimately becoming a covered VA benefit to veterans with PTSD,” Mr. Diamond said in a statement provided to this news organization.

“For servicemembers relying on task-trained service dogs for PTSD, the HR 1448 is a giant leap towards supporting veterans and their service dogs in an equitable way,” Canine Companions, a national nonprofit organization that trains and provides service dogs, said in its own statement.

“It might mean the difference between having a veteran who won’t be here tomorrow and having one that will,” the group added.
 

Invisible wounds of war

In another statement, Bill McCabe, legislative affairs director at the Enlisted Association, said that “now, more than ever, veterans suffering from invisible wounds of war need access to trained service dogs, which have been scientifically proven to help alleviate symptoms of posttraumatic stress,” as well as traumatic brain injuries (TBIs) and military sexual trauma.

“We thank President Biden for recognizing veterans need every possible option when seeking mental health treatments, and look forward to working with the Department of Veterans Affairs to implement this important program,” Mr. McCabe said.

A recent VA report showed that in 2014, 40% of veterans had mental health conditions such as PTSD and substance use. An average of 20 veterans per day died by suicide that year.

Veterans with problems regarding mobility, hearing, and sight, as well as some mental health problems, have been eligible to have costs of veterinary care for service dogs paid by the VA, although the VA has not paid for the training of the animals.

The PAWS Act, which was bipartisan legislation introduced by U.S. Senators Thom Tillis (R-N.C.), Kyrsten Sinema (D-Ariz.), Kevin Cramer (R-N.D.), and Dianne Feinstein (D-Calif.), aims to expand eligibility to those with any mental health problems.

For at least a decade, various service dog and veterans’ organizations have pushed to have the VA expand the service dog benefit. This new law is a “first step,” said Mr. Diamond. “We had to kick open the door,” he said, adding that “the VA has essentially said no for almost 15 years.”

Mr. Diamond noted that there is “overwhelming” evidence showing that service dogs improve quality of life and reduce distress for veterans with PTSD and other diagnoses.
 

‘No excuse’

Results from a VA study showed that suicidal ideation was reduced in veterans who were paired with service dogs, compared with veterans paired with emotional support dogs. The study, which was made public in March, found no reduction in overall disability, according to a report by Military.com.

K9s for Warriors cites numerous other studies, published in peer-reviewed journals, that have shown that service dogs reduce PTSD symptoms, especially hypervigilance.

“There really is no excuse not to have the VA engaged in helping veterans suffering from posttraumatic stress who are extremely high risk of suicide to get a lifesaving service dog,” Mr. Diamond said.

His organization has paired 700 veterans suffering from TBI, PTSD, or military sexual trauma with a service dog. The organization provides a 3-week training program for the veteran and his or her dog.

Although about 200 of the graduates have been eligible to receive coverage from the VA for veterinary care for the dogs, it requires a lot of paperwork, and the criteria for who can be certified to receive that benefit are somewhat vague, Mr. Diamond noted.

Under current policy, the dog and veteran must have successfully completed a training program offered by an organization accredited by Assistance Dogs International or the International Guide Dog Federation. The VA does not pay for the training or the dog – which at K9s for Warriors costs about $25,000.

The new pilot program will enable eligible veterans to receive dog training instruction from accredited nonprofit service dog training organizations, and it will give them the opportunity to adopt a dog that they actively assisted in training.

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

Service members with posttraumatic stress disorder and other mental health conditions may eventually have expanded access to service dogs through legislation recently signed into law by President Joseph R. Biden.

supersizer/E+

The Puppies Assisting Wounded Servicemembers (PAWS) for Veterans Therapy Act (HR 1448) orders the Department of Veterans Affairs to begin a pilot program that over the course of 5 years will examine the utility and effectiveness of service dogs for improving the mental health of military veterans.

The legislation does not set a specific start date for the pilot program, but Rory Diamond, CEO of K9s for Warriors, a nonprofit organization based in Ponte Vedra, Fla., noted that K9s for Warriors and other organizations will be pushing the VA to start in 2022.

“We commend the White House for supporting this bill as a critical step in combating veteran suicide, and we’re confident in the path ahead for service dogs ultimately becoming a covered VA benefit to veterans with PTSD,” Mr. Diamond said in a statement provided to this news organization.

“For servicemembers relying on task-trained service dogs for PTSD, the HR 1448 is a giant leap towards supporting veterans and their service dogs in an equitable way,” Canine Companions, a national nonprofit organization that trains and provides service dogs, said in its own statement.

“It might mean the difference between having a veteran who won’t be here tomorrow and having one that will,” the group added.
 

Invisible wounds of war

In another statement, Bill McCabe, legislative affairs director at the Enlisted Association, said that “now, more than ever, veterans suffering from invisible wounds of war need access to trained service dogs, which have been scientifically proven to help alleviate symptoms of posttraumatic stress,” as well as traumatic brain injuries (TBIs) and military sexual trauma.

“We thank President Biden for recognizing veterans need every possible option when seeking mental health treatments, and look forward to working with the Department of Veterans Affairs to implement this important program,” Mr. McCabe said.

A recent VA report showed that in 2014, 40% of veterans had mental health conditions such as PTSD and substance use. An average of 20 veterans per day died by suicide that year.

Veterans with problems regarding mobility, hearing, and sight, as well as some mental health problems, have been eligible to have costs of veterinary care for service dogs paid by the VA, although the VA has not paid for the training of the animals.

The PAWS Act, which was bipartisan legislation introduced by U.S. Senators Thom Tillis (R-N.C.), Kyrsten Sinema (D-Ariz.), Kevin Cramer (R-N.D.), and Dianne Feinstein (D-Calif.), aims to expand eligibility to those with any mental health problems.

For at least a decade, various service dog and veterans’ organizations have pushed to have the VA expand the service dog benefit. This new law is a “first step,” said Mr. Diamond. “We had to kick open the door,” he said, adding that “the VA has essentially said no for almost 15 years.”

Mr. Diamond noted that there is “overwhelming” evidence showing that service dogs improve quality of life and reduce distress for veterans with PTSD and other diagnoses.
 

‘No excuse’

Results from a VA study showed that suicidal ideation was reduced in veterans who were paired with service dogs, compared with veterans paired with emotional support dogs. The study, which was made public in March, found no reduction in overall disability, according to a report by Military.com.

K9s for Warriors cites numerous other studies, published in peer-reviewed journals, that have shown that service dogs reduce PTSD symptoms, especially hypervigilance.

“There really is no excuse not to have the VA engaged in helping veterans suffering from posttraumatic stress who are extremely high risk of suicide to get a lifesaving service dog,” Mr. Diamond said.

His organization has paired 700 veterans suffering from TBI, PTSD, or military sexual trauma with a service dog. The organization provides a 3-week training program for the veteran and his or her dog.

Although about 200 of the graduates have been eligible to receive coverage from the VA for veterinary care for the dogs, it requires a lot of paperwork, and the criteria for who can be certified to receive that benefit are somewhat vague, Mr. Diamond noted.

Under current policy, the dog and veteran must have successfully completed a training program offered by an organization accredited by Assistance Dogs International or the International Guide Dog Federation. The VA does not pay for the training or the dog – which at K9s for Warriors costs about $25,000.

The new pilot program will enable eligible veterans to receive dog training instruction from accredited nonprofit service dog training organizations, and it will give them the opportunity to adopt a dog that they actively assisted in training.

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

Background: Afib is often asymp­tomatic until a patient presents with an acute stroke. Current screening strategies for Afib fail to detect a large portion of patients, especially since most Afib is paroxysmal. Better screening strategies that increase diagnostic yield are needed.

The authors acknowledged many limitations including: The algorithm used had a sensitivity of 95%, there is no valid cutoffs for time-in-Afib, and the simulations assumed 100% patient compliance.

Bottom line: Screening for atrial fibrillation improves by increasing the duration of, spacing between, and number of screenings.

Citation: Diederichsen SZ et al. Comprehensive evaluation of rhythm monitoring strategies in screening for atrial fibrillation: Insights from patients at risk long-term monitored with implantable loop recorder. Circulation. 2020 May 12;141(19):1510-22.

Dr. Mastbergen is a hospitalist and assistant professor of medicine at UK HealthCare, Lexington, Ky.

Background: Afib is often asymp­tomatic until a patient presents with an acute stroke. Current screening strategies for Afib fail to detect a large portion of patients, especially since most Afib is paroxysmal. Better screening strategies that increase diagnostic yield are needed.

The authors acknowledged many limitations including: The algorithm used had a sensitivity of 95%, there is no valid cutoffs for time-in-Afib, and the simulations assumed 100% patient compliance.

Bottom line: Screening for atrial fibrillation improves by increasing the duration of, spacing between, and number of screenings.

Citation: Diederichsen SZ et al. Comprehensive evaluation of rhythm monitoring strategies in screening for atrial fibrillation: Insights from patients at risk long-term monitored with implantable loop recorder. Circulation. 2020 May 12;141(19):1510-22.

Dr. Mastbergen is a hospitalist and assistant professor of medicine at UK HealthCare, Lexington, Ky.

Background: Afib is often asymp­tomatic until a patient presents with an acute stroke. Current screening strategies for Afib fail to detect a large portion of patients, especially since most Afib is paroxysmal. Better screening strategies that increase diagnostic yield are needed.

The authors acknowledged many limitations including: The algorithm used had a sensitivity of 95%, there is no valid cutoffs for time-in-Afib, and the simulations assumed 100% patient compliance.

Bottom line: Screening for atrial fibrillation improves by increasing the duration of, spacing between, and number of screenings.

Citation: Diederichsen SZ et al. Comprehensive evaluation of rhythm monitoring strategies in screening for atrial fibrillation: Insights from patients at risk long-term monitored with implantable loop recorder. Circulation. 2020 May 12;141(19):1510-22.

Dr. Mastbergen is a hospitalist and assistant professor of medicine at UK HealthCare, Lexington, Ky.

After an extensive review of the present and potential conditions affecting in-person participation, CHEST 2021 will be fully online again this year. Our goal is to make attending CHEST 2021 as accessible as possible for the entire chest medicine community. Make sure to join your colleagues online for the most exciting event in chest medicine, October 17-20.

After an extensive review of the present and potential conditions affecting in-person participation, CHEST 2021 will be fully online again this year. Our goal is to make attending CHEST 2021 as accessible as possible for the entire chest medicine community. Make sure to join your colleagues online for the most exciting event in chest medicine, October 17-20.

After an extensive review of the present and potential conditions affecting in-person participation, CHEST 2021 will be fully online again this year. Our goal is to make attending CHEST 2021 as accessible as possible for the entire chest medicine community. Make sure to join your colleagues online for the most exciting event in chest medicine, October 17-20.

Death from COVID-19 was not more likely among patients with inflammatory bowel disease (IBD) who had COVID-19 who developed new GI symptoms after becoming infected, according to international registry data from nearly 3,000 adults.

Although GI symptoms may arise in the general population of COVID-19 patients, data on the association between GI symptoms and COVID-19 in patients with IBD are limited, as are data on the association of GI symptoms and COVID-19 outcomes in this population, Ryan C. Ungaro, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote.

In a study published in Inflammatory Bowel Diseases, the researchers identified 2,917 adults with IBD who developed COVID-19 using the Surveillance Epidemiology of Coronavirus Under Research Exclusion in Inflammatory Bowel Disease (SECURE-IBD) database, a global registry created to understand COVID-19 outcomes in IBD patients.

The researchers recorded all new GI symptoms experienced by the patients while they were infected with COVID-19. Overall, 764 (26.2%) experienced new GI symptoms and 2,153 did not. The most common symptom was diarrhea, reported by 80% of the patients, followed by abdominal pain in 34%. Nausea and vomiting were reported by 24% and 12%, respectively, of all patients.

The average age of the patients was 43 years for those with no new GI symptoms and 40 for those without new GI symptoms; overall, approximately half were women and approximately three-quarters were White. Overall, 50% of those with new GI symptoms were in remission, as was the case for 58.4% of those without.

IBD patients who developed new GI symptoms were significantly more likely to be women, of Asian race, older, or have at least one comorbidity.

The researchers found no difference in new GI symptoms in patients with Crohn’s disease and ulcerative colitis. “Patients on any medication – but in particular [tumor necrosis factor] antagonist monotherapy – were less likely to report new GI symptoms.” they wrote.

Although IBD patients with new GI symptoms were significantly more likely than were those without new GI symptoms to be hospitalized for COVID-19 in bivariate analyses (31.4% vs. 19.2%; P < .001), they were not more likely to need a ventilator or intensive care (5.8% vs. 4.6%; P < .18). In a multivariate analysis, IBD patients with new GI symptoms had no greater risk of death from COVID-19 than did those without new GI symptoms (adjusted odds ratio, 0.72; 95% confidence interval, 0.38-1.36).

The new-onset GI symptoms common to IBD patients with COVID-19 are not likely caused by underlying disease activity, given the number of patients in remission who reported new GI symptoms, the researchers wrote.

The study findings were limited by several factors including the retrospective design, potential reporting bias, and reliance on physician global assessment for disease assessment, the researchers noted. However, the results were strengthened by the large sample size, by the ability to assess GI symptoms before and after COVID-19, and by the evaluation of GI symptoms and COVID-19 outcomes.

“In summary, new GI symptoms are common in IBD patients with COVID-19 and are not associated with an increased risk of death due to COVID-19,” the researchers concluded. “Our findings suggest that an increase in GI symptoms in IBD patients should prompt consideration of a COVID-19 diagnosis.”
 

Data to guide clinical care

“There are several potential causes for common GI symptoms, such as diarrhea and abdominal pain, among patients with IBD,” Shirley Cohen-Mekelburg, MD, of the University of Michigan, Ann Arbor, said in an interview. “These can be the initial presentation of an IBD flare, a noninflammatory cause such as irritable bowel syndrome, small intestinal bacterial overgrowth, or an infection such as Clostridioides difficile or SARS-CoV-2. Each of these diagnoses require different treatments. An IBD flare may require escalation of immunosuppressive medications such as biologics or corticosteroids, which can cause harm in the context of an untreated infection. Therefore, any guidance that will increase health care providers’ awareness of the possible causes of similar GI symptoms is important in caring for our patients with IBD. This is especially true in context of a newer entity such as COVID-19 with which we are overall less familiar.”

Dr. Cohen-Meckelburg said the lack of association between GI symptoms and death in IBD is reassuring. “It is interesting to note that GI symptoms, and particularly new diarrhea, were very common among patients with IBD and COVID-19,” she added.

“Every study has its limitations, which need to be considered in interpreting findings,” Dr. Cohen-Meckelburg noted . “SECURE-IBD has provided great insight into COVID-19 infections among patients with IBD. However, the registry relies on individuals reporting cases, so there is the potential for underreporting, particularly with less symptomatic or subclinical cases.”

“Health care providers who treat patients with IBD should have a high-index of suspicion for SARS-CoV-2 infections when patients with IBD present with GI symptoms,” said Dr. Cohen-Meckelburg. “The data from the current study may help us to consider standard testing to rule out COVID-19 as an alternative diagnosis when considering whether to treat patients with IBD who develop new GI symptoms for an IBD flare. This would be similar to how we currently test for C. difficile and other enteric infections before treating IBD flares.

“This approach – considering the possibility of COVID-19 in the context of new GI symptoms – is consistent with the AGA’s published guidelines and best practices,” said David Leiman, MD, MSHP, of Duke University, Durham, N.C., and Chair of the AGA’s Quality Committee. “Clinicians should also be aware of the possibility for variation in implementation of this approach, with some patients potentially at risk for disparate testing practices.” As outlined by the AGA’s Quality Committee, tracking adherence to this clinical approach through ongoing quality improvement may limit the development of such gaps in care.

The study was supported in part by the Helmsley Charitable Trust with additional funding provided by Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arenapharm. Lead author Dr. Ungaro disclosed serving as an advisory board member or consultant for AbbVie, Bristol-Myers Squibb, Janssen, Eli Lilly, Pfizer, and Takeda and research support from AbbVie, Boehringer Ingelheim, and Pfizer. Other coauthors disclosed similar relationships with other pharmaceutical companies. Dr. Cohen-Mekelburg and Dr. Leiman had no financial conflicts to disclose.

Death from COVID-19 was not more likely among patients with inflammatory bowel disease (IBD) who had COVID-19 who developed new GI symptoms after becoming infected, according to international registry data from nearly 3,000 adults.

Although GI symptoms may arise in the general population of COVID-19 patients, data on the association between GI symptoms and COVID-19 in patients with IBD are limited, as are data on the association of GI symptoms and COVID-19 outcomes in this population, Ryan C. Ungaro, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote.

In a study published in Inflammatory Bowel Diseases, the researchers identified 2,917 adults with IBD who developed COVID-19 using the Surveillance Epidemiology of Coronavirus Under Research Exclusion in Inflammatory Bowel Disease (SECURE-IBD) database, a global registry created to understand COVID-19 outcomes in IBD patients.

The researchers recorded all new GI symptoms experienced by the patients while they were infected with COVID-19. Overall, 764 (26.2%) experienced new GI symptoms and 2,153 did not. The most common symptom was diarrhea, reported by 80% of the patients, followed by abdominal pain in 34%. Nausea and vomiting were reported by 24% and 12%, respectively, of all patients.

The average age of the patients was 43 years for those with no new GI symptoms and 40 for those without new GI symptoms; overall, approximately half were women and approximately three-quarters were White. Overall, 50% of those with new GI symptoms were in remission, as was the case for 58.4% of those without.

IBD patients who developed new GI symptoms were significantly more likely to be women, of Asian race, older, or have at least one comorbidity.

The researchers found no difference in new GI symptoms in patients with Crohn’s disease and ulcerative colitis. “Patients on any medication – but in particular [tumor necrosis factor] antagonist monotherapy – were less likely to report new GI symptoms.” they wrote.

Although IBD patients with new GI symptoms were significantly more likely than were those without new GI symptoms to be hospitalized for COVID-19 in bivariate analyses (31.4% vs. 19.2%; P < .001), they were not more likely to need a ventilator or intensive care (5.8% vs. 4.6%; P < .18). In a multivariate analysis, IBD patients with new GI symptoms had no greater risk of death from COVID-19 than did those without new GI symptoms (adjusted odds ratio, 0.72; 95% confidence interval, 0.38-1.36).

The new-onset GI symptoms common to IBD patients with COVID-19 are not likely caused by underlying disease activity, given the number of patients in remission who reported new GI symptoms, the researchers wrote.

The study findings were limited by several factors including the retrospective design, potential reporting bias, and reliance on physician global assessment for disease assessment, the researchers noted. However, the results were strengthened by the large sample size, by the ability to assess GI symptoms before and after COVID-19, and by the evaluation of GI symptoms and COVID-19 outcomes.

“In summary, new GI symptoms are common in IBD patients with COVID-19 and are not associated with an increased risk of death due to COVID-19,” the researchers concluded. “Our findings suggest that an increase in GI symptoms in IBD patients should prompt consideration of a COVID-19 diagnosis.”
 

Data to guide clinical care

“There are several potential causes for common GI symptoms, such as diarrhea and abdominal pain, among patients with IBD,” Shirley Cohen-Mekelburg, MD, of the University of Michigan, Ann Arbor, said in an interview. “These can be the initial presentation of an IBD flare, a noninflammatory cause such as irritable bowel syndrome, small intestinal bacterial overgrowth, or an infection such as Clostridioides difficile or SARS-CoV-2. Each of these diagnoses require different treatments. An IBD flare may require escalation of immunosuppressive medications such as biologics or corticosteroids, which can cause harm in the context of an untreated infection. Therefore, any guidance that will increase health care providers’ awareness of the possible causes of similar GI symptoms is important in caring for our patients with IBD. This is especially true in context of a newer entity such as COVID-19 with which we are overall less familiar.”

Dr. Cohen-Meckelburg said the lack of association between GI symptoms and death in IBD is reassuring. “It is interesting to note that GI symptoms, and particularly new diarrhea, were very common among patients with IBD and COVID-19,” she added.

“Every study has its limitations, which need to be considered in interpreting findings,” Dr. Cohen-Meckelburg noted . “SECURE-IBD has provided great insight into COVID-19 infections among patients with IBD. However, the registry relies on individuals reporting cases, so there is the potential for underreporting, particularly with less symptomatic or subclinical cases.”

“Health care providers who treat patients with IBD should have a high-index of suspicion for SARS-CoV-2 infections when patients with IBD present with GI symptoms,” said Dr. Cohen-Meckelburg. “The data from the current study may help us to consider standard testing to rule out COVID-19 as an alternative diagnosis when considering whether to treat patients with IBD who develop new GI symptoms for an IBD flare. This would be similar to how we currently test for C. difficile and other enteric infections before treating IBD flares.

“This approach – considering the possibility of COVID-19 in the context of new GI symptoms – is consistent with the AGA’s published guidelines and best practices,” said David Leiman, MD, MSHP, of Duke University, Durham, N.C., and Chair of the AGA’s Quality Committee. “Clinicians should also be aware of the possibility for variation in implementation of this approach, with some patients potentially at risk for disparate testing practices.” As outlined by the AGA’s Quality Committee, tracking adherence to this clinical approach through ongoing quality improvement may limit the development of such gaps in care.

The study was supported in part by the Helmsley Charitable Trust with additional funding provided by Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arenapharm. Lead author Dr. Ungaro disclosed serving as an advisory board member or consultant for AbbVie, Bristol-Myers Squibb, Janssen, Eli Lilly, Pfizer, and Takeda and research support from AbbVie, Boehringer Ingelheim, and Pfizer. Other coauthors disclosed similar relationships with other pharmaceutical companies. Dr. Cohen-Mekelburg and Dr. Leiman had no financial conflicts to disclose.

Death from COVID-19 was not more likely among patients with inflammatory bowel disease (IBD) who had COVID-19 who developed new GI symptoms after becoming infected, according to international registry data from nearly 3,000 adults.

Although GI symptoms may arise in the general population of COVID-19 patients, data on the association between GI symptoms and COVID-19 in patients with IBD are limited, as are data on the association of GI symptoms and COVID-19 outcomes in this population, Ryan C. Ungaro, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote.

In a study published in Inflammatory Bowel Diseases, the researchers identified 2,917 adults with IBD who developed COVID-19 using the Surveillance Epidemiology of Coronavirus Under Research Exclusion in Inflammatory Bowel Disease (SECURE-IBD) database, a global registry created to understand COVID-19 outcomes in IBD patients.

The researchers recorded all new GI symptoms experienced by the patients while they were infected with COVID-19. Overall, 764 (26.2%) experienced new GI symptoms and 2,153 did not. The most common symptom was diarrhea, reported by 80% of the patients, followed by abdominal pain in 34%. Nausea and vomiting were reported by 24% and 12%, respectively, of all patients.

The average age of the patients was 43 years for those with no new GI symptoms and 40 for those without new GI symptoms; overall, approximately half were women and approximately three-quarters were White. Overall, 50% of those with new GI symptoms were in remission, as was the case for 58.4% of those without.

IBD patients who developed new GI symptoms were significantly more likely to be women, of Asian race, older, or have at least one comorbidity.

The researchers found no difference in new GI symptoms in patients with Crohn’s disease and ulcerative colitis. “Patients on any medication – but in particular [tumor necrosis factor] antagonist monotherapy – were less likely to report new GI symptoms.” they wrote.

Although IBD patients with new GI symptoms were significantly more likely than were those without new GI symptoms to be hospitalized for COVID-19 in bivariate analyses (31.4% vs. 19.2%; P < .001), they were not more likely to need a ventilator or intensive care (5.8% vs. 4.6%; P < .18). In a multivariate analysis, IBD patients with new GI symptoms had no greater risk of death from COVID-19 than did those without new GI symptoms (adjusted odds ratio, 0.72; 95% confidence interval, 0.38-1.36).

The new-onset GI symptoms common to IBD patients with COVID-19 are not likely caused by underlying disease activity, given the number of patients in remission who reported new GI symptoms, the researchers wrote.

The study findings were limited by several factors including the retrospective design, potential reporting bias, and reliance on physician global assessment for disease assessment, the researchers noted. However, the results were strengthened by the large sample size, by the ability to assess GI symptoms before and after COVID-19, and by the evaluation of GI symptoms and COVID-19 outcomes.

“In summary, new GI symptoms are common in IBD patients with COVID-19 and are not associated with an increased risk of death due to COVID-19,” the researchers concluded. “Our findings suggest that an increase in GI symptoms in IBD patients should prompt consideration of a COVID-19 diagnosis.”
 

Data to guide clinical care

“There are several potential causes for common GI symptoms, such as diarrhea and abdominal pain, among patients with IBD,” Shirley Cohen-Mekelburg, MD, of the University of Michigan, Ann Arbor, said in an interview. “These can be the initial presentation of an IBD flare, a noninflammatory cause such as irritable bowel syndrome, small intestinal bacterial overgrowth, or an infection such as Clostridioides difficile or SARS-CoV-2. Each of these diagnoses require different treatments. An IBD flare may require escalation of immunosuppressive medications such as biologics or corticosteroids, which can cause harm in the context of an untreated infection. Therefore, any guidance that will increase health care providers’ awareness of the possible causes of similar GI symptoms is important in caring for our patients with IBD. This is especially true in context of a newer entity such as COVID-19 with which we are overall less familiar.”

Dr. Cohen-Meckelburg said the lack of association between GI symptoms and death in IBD is reassuring. “It is interesting to note that GI symptoms, and particularly new diarrhea, were very common among patients with IBD and COVID-19,” she added.

“Every study has its limitations, which need to be considered in interpreting findings,” Dr. Cohen-Meckelburg noted . “SECURE-IBD has provided great insight into COVID-19 infections among patients with IBD. However, the registry relies on individuals reporting cases, so there is the potential for underreporting, particularly with less symptomatic or subclinical cases.”

“Health care providers who treat patients with IBD should have a high-index of suspicion for SARS-CoV-2 infections when patients with IBD present with GI symptoms,” said Dr. Cohen-Meckelburg. “The data from the current study may help us to consider standard testing to rule out COVID-19 as an alternative diagnosis when considering whether to treat patients with IBD who develop new GI symptoms for an IBD flare. This would be similar to how we currently test for C. difficile and other enteric infections before treating IBD flares.

“This approach – considering the possibility of COVID-19 in the context of new GI symptoms – is consistent with the AGA’s published guidelines and best practices,” said David Leiman, MD, MSHP, of Duke University, Durham, N.C., and Chair of the AGA’s Quality Committee. “Clinicians should also be aware of the possibility for variation in implementation of this approach, with some patients potentially at risk for disparate testing practices.” As outlined by the AGA’s Quality Committee, tracking adherence to this clinical approach through ongoing quality improvement may limit the development of such gaps in care.

The study was supported in part by the Helmsley Charitable Trust with additional funding provided by Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arenapharm. Lead author Dr. Ungaro disclosed serving as an advisory board member or consultant for AbbVie, Bristol-Myers Squibb, Janssen, Eli Lilly, Pfizer, and Takeda and research support from AbbVie, Boehringer Ingelheim, and Pfizer. Other coauthors disclosed similar relationships with other pharmaceutical companies. Dr. Cohen-Mekelburg and Dr. Leiman had no financial conflicts to disclose.

Updated August 30, 2021

The SGLT2 inhibitor empagliflozin achieved in EMPEROR-Preserved what no other agent could previously do: unequivocally cut the incidence of cardiovascular death or hospitalization in patients with heart failure and preserved ejection fraction (HFpEF).

MDedge News

Treatment with empagliflozin (Jardiance) led to a significant 21% relative reduction in the rate of cardiovascular death or hospitalization for heart failure (HHF), compared with placebo, among 5,988 randomized patients with HFpEF during a median 26 months of follow-up, proving that patients with HFpEF finally have a treatment that gives them clinically meaningful benefit, and paving the way to an abrupt change in management of these patients, experts said.

“This is the first trial to show unequivocal benefits of any drug on major heart failure outcomes in patients with HFpEF,” Stefan D. Anker, MD, PhD, declared at the virtual annual congress of the European Society of Cardiology.

The 21% relative reduction, which reflected a cut in the absolute rate of the trial’s primary composite endpoint of 3.3% compared with placebo, was driven mainly by a significant 27% relative reduction in the incidence of HHF (P < .001). Empagliflozin treatment, on top of standard therapy for patients with HFpEF, also resulted in a nonsignificant 9% relative risk reduction in the incidence of cardiovascular death, but it had no discernible impact on the rate of death from any cause, said Dr. Anker, professor of cardiology at Charité Medical University in Berlin.

Concurrently with his talk at the meeting, the results were published online in the New England Journal of Medicine.
 

Practice will change ‘quickly’

“This will definitely change our practice, and quite quickly,” said Carlos Aguiar, MD, chair of the Advanced Heart Failure and Heart Transplantation Unit at Hospital Santa Cruz in Carnaxide, Portugal, who was not involved in the study.

Transition to routine use of empagliflozin in patients with HFpEF should be swift because it has already become a mainstay of treatment for patients with heart failure with reduced ejection fraction (HFrEF) based on evidence for empagliflozin in EMPEROR-Reduced. A second sodium-glucose cotransporter 2 (SGLT2 ) inhibitor, dapagliflozin (Farxiga), is also an option for treating HFrEF based on results in the DAPA-HF trial, and the DELIVER trial, still in progress, is testing dapagliflozin as a HFpEF treatment in about 6,000 patients, with results expected in 2022.

About half of the patients in EMPEROR-Preserved had diabetes, and the treatment effects on HFpEF were similar regardless of patients’ diabetes status. Empagliflozin, like other members of the SGLT2 inhibitor class, boosts urinary excretion of glucose and received initial regulatory approval as an agent for glycemic control in patients with type 2 diabetes. Empagliflozin also has U.S.-approved marketing indications for treating patients with HFrEF whether or not they also have diabetes, and for reducing cardiovascular death in patients with type 2 diabetes and cardiovascular disease.

“We already use this drug class in cardiovascular medicine and to treat patients with type 2 diabetes, and we have been eager to find a treatment for patients with HFpEF. This is something that will be really significant,” said Dr. Aguiar.

Heart failure clinicians have “become familiar prescribing” SGLT2 inhibitors following approval of HFrEF indications for some of these agents, noted Mary Norine Walsh, MD, a heart failure specialist with Ascension Medical Group in Indianapolis. The new results “are good news because there have been so few options” for patients with HFpEF, she said in an interview.

EMPEROR-Preserved “is the first phase 3 clinical trial that exclusively enrolled patients with heart failure and an ejection fraction of more than 40% to meet its primary outcome,” and the results “represent a major win against a medical condition that had previously proven formidable,” Mark H. Drazner, MD, said in an editorial that accompanied the published results.

The trial’s findings “should contribute to a change in clinical practice given the paucity of therapeutic options available for patients with HFpEF,” wrote Dr. Drazner, a heart failure specialist who is professor and clinical chief of cardiology at UT Southwestern Medical Center in Dallas.

Theresa A, McDonagh, MD, MBChB, who chaired the panel that just released revised guidelines from the European Society of Cardiology for managing patients with heart failure, predicted that empagliflozin treatment for patients with HFpEF will soon show up in guidelines. It will likely receive a “should be considered” ranking despite being a single study because of the impressive size of the treatment effect and lack of well-supported alternative treatments, she commented as a discussant of the trial during its presentation at the congress. If the DELIVER trial with dapagliflozin shows a similar effect, the recommendation would likely become even stronger, added Dr. McDonagh, a heart failure specialist and professor of cardiology at King’s College, London.

More women enrolled than ever before

EMPEROR-Preserved enrolled adults with chronic HFpEF in New York Heart Association functional class II-IV and a left ventricular ejection fraction greater than 40% starting in 2017 at more than 600 sites in more than 20 countries worldwide including the United States. As background therapy, more than 80% of patients received treatment with either an ACE inhibitor or angiotensin receptor blocker (in some instances in the form of sacubitril/valsartan), more than 80% were on a beta-blocker, and about a third were taking a mineralocorticoid receptor antagonist, making them “very well treated HFpEF patients,” Dr. Anker said.

One of the most notable features of enrollment was that 45% of participants were women, giving this trial the highest inclusion of women compared with all prior studies in patients with HFpEF or with HFrEF, said Dr. Walsh. “HFpEF is very prevalent in woman,” she noted, and having this high participation rate of women in the study increases its relevance to these patients. “It’s important to be able to tell women that patients like you were in the study so we can more easily apply the lessons from the trial to you. That can’t be stressed enough,” she said.

The primary outcome occurred in 415 (13.8%) of the 2,997 patients in the empagliflozin group and in 511 (17.1%) of 2,991 patients who received placebo (hazard ratio, 0.79; 95% confidence interval, 0.69-0.90; P < .001).

The study showed a safety profile consistent with prior experience with empagliflozin, Dr. Anker added.

Pooling EMPEROR-Preserved with EMPEROR-Reduced

The investigators who ran EMPEROR-Preserved designed the trial to closely parallel the EMPEROR-Reduced trial in patients with HFrEF, and they included a prespecified analysis (EMPEROR-Pooled) that combined the more than 9,700 patients in the two studies. This showed a consistent and robust benefit from empagliflozin for reducing HHF across a wide spectrum of patients with heart failure, ranging from patients with left ventricular ejection fractions of less than 25% to patients with ejection fractions as high as 64%. However, the analysis also showed that patients with ejection fractions of 65% or greater received no discernible benefit from empagliflozin, Milton Packer, MD, reported in a separate talk at the congress.

MDedge News

“The findings demonstrate the benefits of empagliflozin across a broad range of patients with heart failure who have ejection fractions of less than 60%-65%,” said Dr. Packer, a researcher at Baylor University Medical Center in Dallas.

This apparent attenuation of an effect at higher ejection fractions “has been observed in other HFpEF trials, most recently in the PARAGON-HF trial” of sacubitril/valsartan (Entresto), he noted. Additional analyses led by Dr. Packer showed that in patients with ejection fractions below 65% the HHF benefit from empagliflozin consistently surpassed the benefit seen with sacubitril/valsartan in PARAGON-HF. But he recommended using both drugs in patients with HFpEF and an ejection fraction up to about 60%.

“If I had a patient with HFpEF I would use both drugs as well as beta-blockers and mineralocorticoid receptor antagonists,” he said during a press briefing.

Another finding from analysis of the EMPEROR-Reduced and EMPEROR-Preserved trials together was that patients with reduced ejection fractions showed a significant 49% relative reduction in the incidence of serious renal outcomes, but this effect was completely blunted in EMPEROR-Preserved.

“Ejection fraction influences the effects of empagliflozin on major renal outcomes,” concluded Dr. Packer in a report on this analysis published simultaneously with the main EMPEROR-Preserved findings (N Engl J Med. 2021 Aug 27. doi: 10.1056/NEJMc2112411). “These data from the EMPEROR trials are unique. We have no comparable data” from any of the other reported studies of SGLT2 inhibitors,” he said.

EMPEROR-Preserved was sponsored by Boehringer Ingelheim and by Eli Lilly, the two companies that jointly market empagliflozin (Jardiance). Dr. Anker has received personal fees from Boehringer Ingelheim and from several other companies, and he has received grants and personal fees from Abbott Vascular and Vifor. Dr. Packer has received consulting fees from Boehringer Ingelheim and from numerous other companies. Dr. McDonagh has has recent financial relationships with AstraZeneca, Cprpus, Novartis, Pfizer, and Vifor. Dr. Aguiar and Dr. Walsh had no disclosures.

[email protected]

Updated August 30, 2021

The SGLT2 inhibitor empagliflozin achieved in EMPEROR-Preserved what no other agent could previously do: unequivocally cut the incidence of cardiovascular death or hospitalization in patients with heart failure and preserved ejection fraction (HFpEF).

MDedge News

Treatment with empagliflozin (Jardiance) led to a significant 21% relative reduction in the rate of cardiovascular death or hospitalization for heart failure (HHF), compared with placebo, among 5,988 randomized patients with HFpEF during a median 26 months of follow-up, proving that patients with HFpEF finally have a treatment that gives them clinically meaningful benefit, and paving the way to an abrupt change in management of these patients, experts said.

“This is the first trial to show unequivocal benefits of any drug on major heart failure outcomes in patients with HFpEF,” Stefan D. Anker, MD, PhD, declared at the virtual annual congress of the European Society of Cardiology.

The 21% relative reduction, which reflected a cut in the absolute rate of the trial’s primary composite endpoint of 3.3% compared with placebo, was driven mainly by a significant 27% relative reduction in the incidence of HHF (P < .001). Empagliflozin treatment, on top of standard therapy for patients with HFpEF, also resulted in a nonsignificant 9% relative risk reduction in the incidence of cardiovascular death, but it had no discernible impact on the rate of death from any cause, said Dr. Anker, professor of cardiology at Charité Medical University in Berlin.

Concurrently with his talk at the meeting, the results were published online in the New England Journal of Medicine.
 

Practice will change ‘quickly’

“This will definitely change our practice, and quite quickly,” said Carlos Aguiar, MD, chair of the Advanced Heart Failure and Heart Transplantation Unit at Hospital Santa Cruz in Carnaxide, Portugal, who was not involved in the study.

Transition to routine use of empagliflozin in patients with HFpEF should be swift because it has already become a mainstay of treatment for patients with heart failure with reduced ejection fraction (HFrEF) based on evidence for empagliflozin in EMPEROR-Reduced. A second sodium-glucose cotransporter 2 (SGLT2 ) inhibitor, dapagliflozin (Farxiga), is also an option for treating HFrEF based on results in the DAPA-HF trial, and the DELIVER trial, still in progress, is testing dapagliflozin as a HFpEF treatment in about 6,000 patients, with results expected in 2022.

About half of the patients in EMPEROR-Preserved had diabetes, and the treatment effects on HFpEF were similar regardless of patients’ diabetes status. Empagliflozin, like other members of the SGLT2 inhibitor class, boosts urinary excretion of glucose and received initial regulatory approval as an agent for glycemic control in patients with type 2 diabetes. Empagliflozin also has U.S.-approved marketing indications for treating patients with HFrEF whether or not they also have diabetes, and for reducing cardiovascular death in patients with type 2 diabetes and cardiovascular disease.

“We already use this drug class in cardiovascular medicine and to treat patients with type 2 diabetes, and we have been eager to find a treatment for patients with HFpEF. This is something that will be really significant,” said Dr. Aguiar.

Heart failure clinicians have “become familiar prescribing” SGLT2 inhibitors following approval of HFrEF indications for some of these agents, noted Mary Norine Walsh, MD, a heart failure specialist with Ascension Medical Group in Indianapolis. The new results “are good news because there have been so few options” for patients with HFpEF, she said in an interview.

EMPEROR-Preserved “is the first phase 3 clinical trial that exclusively enrolled patients with heart failure and an ejection fraction of more than 40% to meet its primary outcome,” and the results “represent a major win against a medical condition that had previously proven formidable,” Mark H. Drazner, MD, said in an editorial that accompanied the published results.

The trial’s findings “should contribute to a change in clinical practice given the paucity of therapeutic options available for patients with HFpEF,” wrote Dr. Drazner, a heart failure specialist who is professor and clinical chief of cardiology at UT Southwestern Medical Center in Dallas.

Theresa A, McDonagh, MD, MBChB, who chaired the panel that just released revised guidelines from the European Society of Cardiology for managing patients with heart failure, predicted that empagliflozin treatment for patients with HFpEF will soon show up in guidelines. It will likely receive a “should be considered” ranking despite being a single study because of the impressive size of the treatment effect and lack of well-supported alternative treatments, she commented as a discussant of the trial during its presentation at the congress. If the DELIVER trial with dapagliflozin shows a similar effect, the recommendation would likely become even stronger, added Dr. McDonagh, a heart failure specialist and professor of cardiology at King’s College, London.

More women enrolled than ever before

EMPEROR-Preserved enrolled adults with chronic HFpEF in New York Heart Association functional class II-IV and a left ventricular ejection fraction greater than 40% starting in 2017 at more than 600 sites in more than 20 countries worldwide including the United States. As background therapy, more than 80% of patients received treatment with either an ACE inhibitor or angiotensin receptor blocker (in some instances in the form of sacubitril/valsartan), more than 80% were on a beta-blocker, and about a third were taking a mineralocorticoid receptor antagonist, making them “very well treated HFpEF patients,” Dr. Anker said.

One of the most notable features of enrollment was that 45% of participants were women, giving this trial the highest inclusion of women compared with all prior studies in patients with HFpEF or with HFrEF, said Dr. Walsh. “HFpEF is very prevalent in woman,” she noted, and having this high participation rate of women in the study increases its relevance to these patients. “It’s important to be able to tell women that patients like you were in the study so we can more easily apply the lessons from the trial to you. That can’t be stressed enough,” she said.

The primary outcome occurred in 415 (13.8%) of the 2,997 patients in the empagliflozin group and in 511 (17.1%) of 2,991 patients who received placebo (hazard ratio, 0.79; 95% confidence interval, 0.69-0.90; P < .001).

The study showed a safety profile consistent with prior experience with empagliflozin, Dr. Anker added.

Pooling EMPEROR-Preserved with EMPEROR-Reduced

The investigators who ran EMPEROR-Preserved designed the trial to closely parallel the EMPEROR-Reduced trial in patients with HFrEF, and they included a prespecified analysis (EMPEROR-Pooled) that combined the more than 9,700 patients in the two studies. This showed a consistent and robust benefit from empagliflozin for reducing HHF across a wide spectrum of patients with heart failure, ranging from patients with left ventricular ejection fractions of less than 25% to patients with ejection fractions as high as 64%. However, the analysis also showed that patients with ejection fractions of 65% or greater received no discernible benefit from empagliflozin, Milton Packer, MD, reported in a separate talk at the congress.

MDedge News

“The findings demonstrate the benefits of empagliflozin across a broad range of patients with heart failure who have ejection fractions of less than 60%-65%,” said Dr. Packer, a researcher at Baylor University Medical Center in Dallas.

This apparent attenuation of an effect at higher ejection fractions “has been observed in other HFpEF trials, most recently in the PARAGON-HF trial” of sacubitril/valsartan (Entresto), he noted. Additional analyses led by Dr. Packer showed that in patients with ejection fractions below 65% the HHF benefit from empagliflozin consistently surpassed the benefit seen with sacubitril/valsartan in PARAGON-HF. But he recommended using both drugs in patients with HFpEF and an ejection fraction up to about 60%.

“If I had a patient with HFpEF I would use both drugs as well as beta-blockers and mineralocorticoid receptor antagonists,” he said during a press briefing.

Another finding from analysis of the EMPEROR-Reduced and EMPEROR-Preserved trials together was that patients with reduced ejection fractions showed a significant 49% relative reduction in the incidence of serious renal outcomes, but this effect was completely blunted in EMPEROR-Preserved.

“Ejection fraction influences the effects of empagliflozin on major renal outcomes,” concluded Dr. Packer in a report on this analysis published simultaneously with the main EMPEROR-Preserved findings (N Engl J Med. 2021 Aug 27. doi: 10.1056/NEJMc2112411). “These data from the EMPEROR trials are unique. We have no comparable data” from any of the other reported studies of SGLT2 inhibitors,” he said.

EMPEROR-Preserved was sponsored by Boehringer Ingelheim and by Eli Lilly, the two companies that jointly market empagliflozin (Jardiance). Dr. Anker has received personal fees from Boehringer Ingelheim and from several other companies, and he has received grants and personal fees from Abbott Vascular and Vifor. Dr. Packer has received consulting fees from Boehringer Ingelheim and from numerous other companies. Dr. McDonagh has has recent financial relationships with AstraZeneca, Cprpus, Novartis, Pfizer, and Vifor. Dr. Aguiar and Dr. Walsh had no disclosures.

[email protected]

Updated August 30, 2021

The SGLT2 inhibitor empagliflozin achieved in EMPEROR-Preserved what no other agent could previously do: unequivocally cut the incidence of cardiovascular death or hospitalization in patients with heart failure and preserved ejection fraction (HFpEF).

MDedge News

Treatment with empagliflozin (Jardiance) led to a significant 21% relative reduction in the rate of cardiovascular death or hospitalization for heart failure (HHF), compared with placebo, among 5,988 randomized patients with HFpEF during a median 26 months of follow-up, proving that patients with HFpEF finally have a treatment that gives them clinically meaningful benefit, and paving the way to an abrupt change in management of these patients, experts said.

“This is the first trial to show unequivocal benefits of any drug on major heart failure outcomes in patients with HFpEF,” Stefan D. Anker, MD, PhD, declared at the virtual annual congress of the European Society of Cardiology.

The 21% relative reduction, which reflected a cut in the absolute rate of the trial’s primary composite endpoint of 3.3% compared with placebo, was driven mainly by a significant 27% relative reduction in the incidence of HHF (P < .001). Empagliflozin treatment, on top of standard therapy for patients with HFpEF, also resulted in a nonsignificant 9% relative risk reduction in the incidence of cardiovascular death, but it had no discernible impact on the rate of death from any cause, said Dr. Anker, professor of cardiology at Charité Medical University in Berlin.

Concurrently with his talk at the meeting, the results were published online in the New England Journal of Medicine.
 

Practice will change ‘quickly’

“This will definitely change our practice, and quite quickly,” said Carlos Aguiar, MD, chair of the Advanced Heart Failure and Heart Transplantation Unit at Hospital Santa Cruz in Carnaxide, Portugal, who was not involved in the study.

Transition to routine use of empagliflozin in patients with HFpEF should be swift because it has already become a mainstay of treatment for patients with heart failure with reduced ejection fraction (HFrEF) based on evidence for empagliflozin in EMPEROR-Reduced. A second sodium-glucose cotransporter 2 (SGLT2 ) inhibitor, dapagliflozin (Farxiga), is also an option for treating HFrEF based on results in the DAPA-HF trial, and the DELIVER trial, still in progress, is testing dapagliflozin as a HFpEF treatment in about 6,000 patients, with results expected in 2022.

About half of the patients in EMPEROR-Preserved had diabetes, and the treatment effects on HFpEF were similar regardless of patients’ diabetes status. Empagliflozin, like other members of the SGLT2 inhibitor class, boosts urinary excretion of glucose and received initial regulatory approval as an agent for glycemic control in patients with type 2 diabetes. Empagliflozin also has U.S.-approved marketing indications for treating patients with HFrEF whether or not they also have diabetes, and for reducing cardiovascular death in patients with type 2 diabetes and cardiovascular disease.

“We already use this drug class in cardiovascular medicine and to treat patients with type 2 diabetes, and we have been eager to find a treatment for patients with HFpEF. This is something that will be really significant,” said Dr. Aguiar.

Heart failure clinicians have “become familiar prescribing” SGLT2 inhibitors following approval of HFrEF indications for some of these agents, noted Mary Norine Walsh, MD, a heart failure specialist with Ascension Medical Group in Indianapolis. The new results “are good news because there have been so few options” for patients with HFpEF, she said in an interview.

EMPEROR-Preserved “is the first phase 3 clinical trial that exclusively enrolled patients with heart failure and an ejection fraction of more than 40% to meet its primary outcome,” and the results “represent a major win against a medical condition that had previously proven formidable,” Mark H. Drazner, MD, said in an editorial that accompanied the published results.

The trial’s findings “should contribute to a change in clinical practice given the paucity of therapeutic options available for patients with HFpEF,” wrote Dr. Drazner, a heart failure specialist who is professor and clinical chief of cardiology at UT Southwestern Medical Center in Dallas.

Theresa A, McDonagh, MD, MBChB, who chaired the panel that just released revised guidelines from the European Society of Cardiology for managing patients with heart failure, predicted that empagliflozin treatment for patients with HFpEF will soon show up in guidelines. It will likely receive a “should be considered” ranking despite being a single study because of the impressive size of the treatment effect and lack of well-supported alternative treatments, she commented as a discussant of the trial during its presentation at the congress. If the DELIVER trial with dapagliflozin shows a similar effect, the recommendation would likely become even stronger, added Dr. McDonagh, a heart failure specialist and professor of cardiology at King’s College, London.

More women enrolled than ever before

EMPEROR-Preserved enrolled adults with chronic HFpEF in New York Heart Association functional class II-IV and a left ventricular ejection fraction greater than 40% starting in 2017 at more than 600 sites in more than 20 countries worldwide including the United States. As background therapy, more than 80% of patients received treatment with either an ACE inhibitor or angiotensin receptor blocker (in some instances in the form of sacubitril/valsartan), more than 80% were on a beta-blocker, and about a third were taking a mineralocorticoid receptor antagonist, making them “very well treated HFpEF patients,” Dr. Anker said.

One of the most notable features of enrollment was that 45% of participants were women, giving this trial the highest inclusion of women compared with all prior studies in patients with HFpEF or with HFrEF, said Dr. Walsh. “HFpEF is very prevalent in woman,” she noted, and having this high participation rate of women in the study increases its relevance to these patients. “It’s important to be able to tell women that patients like you were in the study so we can more easily apply the lessons from the trial to you. That can’t be stressed enough,” she said.

The primary outcome occurred in 415 (13.8%) of the 2,997 patients in the empagliflozin group and in 511 (17.1%) of 2,991 patients who received placebo (hazard ratio, 0.79; 95% confidence interval, 0.69-0.90; P < .001).

The study showed a safety profile consistent with prior experience with empagliflozin, Dr. Anker added.

Pooling EMPEROR-Preserved with EMPEROR-Reduced

The investigators who ran EMPEROR-Preserved designed the trial to closely parallel the EMPEROR-Reduced trial in patients with HFrEF, and they included a prespecified analysis (EMPEROR-Pooled) that combined the more than 9,700 patients in the two studies. This showed a consistent and robust benefit from empagliflozin for reducing HHF across a wide spectrum of patients with heart failure, ranging from patients with left ventricular ejection fractions of less than 25% to patients with ejection fractions as high as 64%. However, the analysis also showed that patients with ejection fractions of 65% or greater received no discernible benefit from empagliflozin, Milton Packer, MD, reported in a separate talk at the congress.

MDedge News

“The findings demonstrate the benefits of empagliflozin across a broad range of patients with heart failure who have ejection fractions of less than 60%-65%,” said Dr. Packer, a researcher at Baylor University Medical Center in Dallas.

This apparent attenuation of an effect at higher ejection fractions “has been observed in other HFpEF trials, most recently in the PARAGON-HF trial” of sacubitril/valsartan (Entresto), he noted. Additional analyses led by Dr. Packer showed that in patients with ejection fractions below 65% the HHF benefit from empagliflozin consistently surpassed the benefit seen with sacubitril/valsartan in PARAGON-HF. But he recommended using both drugs in patients with HFpEF and an ejection fraction up to about 60%.

“If I had a patient with HFpEF I would use both drugs as well as beta-blockers and mineralocorticoid receptor antagonists,” he said during a press briefing.

Another finding from analysis of the EMPEROR-Reduced and EMPEROR-Preserved trials together was that patients with reduced ejection fractions showed a significant 49% relative reduction in the incidence of serious renal outcomes, but this effect was completely blunted in EMPEROR-Preserved.

“Ejection fraction influences the effects of empagliflozin on major renal outcomes,” concluded Dr. Packer in a report on this analysis published simultaneously with the main EMPEROR-Preserved findings (N Engl J Med. 2021 Aug 27. doi: 10.1056/NEJMc2112411). “These data from the EMPEROR trials are unique. We have no comparable data” from any of the other reported studies of SGLT2 inhibitors,” he said.

EMPEROR-Preserved was sponsored by Boehringer Ingelheim and by Eli Lilly, the two companies that jointly market empagliflozin (Jardiance). Dr. Anker has received personal fees from Boehringer Ingelheim and from several other companies, and he has received grants and personal fees from Abbott Vascular and Vifor. Dr. Packer has received consulting fees from Boehringer Ingelheim and from numerous other companies. Dr. McDonagh has has recent financial relationships with AstraZeneca, Cprpus, Novartis, Pfizer, and Vifor. Dr. Aguiar and Dr. Walsh had no disclosures.

[email protected]

“By learning you will teach, by teaching you will learn.”

–Latin proverb

The COVID-19 pandemic thrust hospitalists into uncertain clinical situations where scientific evidence was rapidly changing and expert consensus was not always available. Amidst this, our learners were eager to better understand this new disease and how to properly care for patients. This forced hospitalists, as educators, to face the question: “How do you teach when you don’t have the answers?”

Teaching outside a hospitalist’s expertise existed before the COVID-19 pandemic and will continue to exist. It is a challenge encountered frequently by both junior and senior faculty across all disciplines, yet is rarely discussed.¹ However, great learning can still occur when we teach at the edge of our comfort zones.

You don’t need to be an expert to be a great teacher. Although most educators know this, we often fear that disclosing our knowledge limitations exposes our weaknesses. But a successful start to the learning journey begins with establishing trust and confidence with your learners. Remaining authentic in your knowledge base will inspire more credibility than false pretenses of content mastery. Phrases like, “This topic is new for me as well. Here’s what I do know and what I don’t know” or “What a great question. I wish I had a great answer. Let me get back to you” set a standard for honesty and reduce teaching pressures. In turn, learners will be more comfortable acknowledging their own uncertainties and will be more likely to voice their hesitations or ask questions on rounds.

The field of medicine is steeped in hierarchical structure, where the attending is assumed to have the most knowledge. But this may not always be true, as learners are often more up to date on a subject than the attending. By reexamining traditional hierarchies and instead considering ourselves as part of a learning team, we can promote a more positive educational climate.

When a learner asks a question that you don’t have an answer for, the response “Great question. I can tell you what I think, but I’m interested in first hearing your thoughts” reflects that you respect your learners and their skills and experiences. You can also ask them to do a literature review and report back to you and the team the next morning. By inverting the hierarchy, you are teaching humility, adaptability, and shared responsibility, as well as demonstrating the skills of being a lifelong learner.²

As educators, we often hold ourselves to unrealistic expectations of being omniscient knowledge vessels. In times of crisis or uncertainty, teaching about how to learn and where to learn become just as important as what to learn. Invite learners to observe how you navigate ambiguity. For example, I recently interacted with a colleague on an unfamiliar case. She said, “Dr Wang, I don’t know much about malaria. Can you share with me what made you consider this diagnosis?” Additionally, admitting to learners when you have made an error not only clarifies their learning, but also role models continuous personal improvement.

By modeling humility by acknowledging our own limits, respecting our learners’ knowledge and experiences, and demonstrating how we manage uncertainty, we can enhance the learning environment and inspire our learners.

“By learning you will teach, by teaching you will learn.”

–Latin proverb

The COVID-19 pandemic thrust hospitalists into uncertain clinical situations where scientific evidence was rapidly changing and expert consensus was not always available. Amidst this, our learners were eager to better understand this new disease and how to properly care for patients. This forced hospitalists, as educators, to face the question: “How do you teach when you don’t have the answers?”

Teaching outside a hospitalist’s expertise existed before the COVID-19 pandemic and will continue to exist. It is a challenge encountered frequently by both junior and senior faculty across all disciplines, yet is rarely discussed.¹ However, great learning can still occur when we teach at the edge of our comfort zones.

You don’t need to be an expert to be a great teacher. Although most educators know this, we often fear that disclosing our knowledge limitations exposes our weaknesses. But a successful start to the learning journey begins with establishing trust and confidence with your learners. Remaining authentic in your knowledge base will inspire more credibility than false pretenses of content mastery. Phrases like, “This topic is new for me as well. Here’s what I do know and what I don’t know” or “What a great question. I wish I had a great answer. Let me get back to you” set a standard for honesty and reduce teaching pressures. In turn, learners will be more comfortable acknowledging their own uncertainties and will be more likely to voice their hesitations or ask questions on rounds.

The field of medicine is steeped in hierarchical structure, where the attending is assumed to have the most knowledge. But this may not always be true, as learners are often more up to date on a subject than the attending. By reexamining traditional hierarchies and instead considering ourselves as part of a learning team, we can promote a more positive educational climate.

When a learner asks a question that you don’t have an answer for, the response “Great question. I can tell you what I think, but I’m interested in first hearing your thoughts” reflects that you respect your learners and their skills and experiences. You can also ask them to do a literature review and report back to you and the team the next morning. By inverting the hierarchy, you are teaching humility, adaptability, and shared responsibility, as well as demonstrating the skills of being a lifelong learner.²

As educators, we often hold ourselves to unrealistic expectations of being omniscient knowledge vessels. In times of crisis or uncertainty, teaching about how to learn and where to learn become just as important as what to learn. Invite learners to observe how you navigate ambiguity. For example, I recently interacted with a colleague on an unfamiliar case. She said, “Dr Wang, I don’t know much about malaria. Can you share with me what made you consider this diagnosis?” Additionally, admitting to learners when you have made an error not only clarifies their learning, but also role models continuous personal improvement.

By modeling humility by acknowledging our own limits, respecting our learners’ knowledge and experiences, and demonstrating how we manage uncertainty, we can enhance the learning environment and inspire our learners.

“By learning you will teach, by teaching you will learn.”

–Latin proverb

The COVID-19 pandemic thrust hospitalists into uncertain clinical situations where scientific evidence was rapidly changing and expert consensus was not always available. Amidst this, our learners were eager to better understand this new disease and how to properly care for patients. This forced hospitalists, as educators, to face the question: “How do you teach when you don’t have the answers?”

Teaching outside a hospitalist’s expertise existed before the COVID-19 pandemic and will continue to exist. It is a challenge encountered frequently by both junior and senior faculty across all disciplines, yet is rarely discussed.¹ However, great learning can still occur when we teach at the edge of our comfort zones.

You don’t need to be an expert to be a great teacher. Although most educators know this, we often fear that disclosing our knowledge limitations exposes our weaknesses. But a successful start to the learning journey begins with establishing trust and confidence with your learners. Remaining authentic in your knowledge base will inspire more credibility than false pretenses of content mastery. Phrases like, “This topic is new for me as well. Here’s what I do know and what I don’t know” or “What a great question. I wish I had a great answer. Let me get back to you” set a standard for honesty and reduce teaching pressures. In turn, learners will be more comfortable acknowledging their own uncertainties and will be more likely to voice their hesitations or ask questions on rounds.

The field of medicine is steeped in hierarchical structure, where the attending is assumed to have the most knowledge. But this may not always be true, as learners are often more up to date on a subject than the attending. By reexamining traditional hierarchies and instead considering ourselves as part of a learning team, we can promote a more positive educational climate.

When a learner asks a question that you don’t have an answer for, the response “Great question. I can tell you what I think, but I’m interested in first hearing your thoughts” reflects that you respect your learners and their skills and experiences. You can also ask them to do a literature review and report back to you and the team the next morning. By inverting the hierarchy, you are teaching humility, adaptability, and shared responsibility, as well as demonstrating the skills of being a lifelong learner.²

As educators, we often hold ourselves to unrealistic expectations of being omniscient knowledge vessels. In times of crisis or uncertainty, teaching about how to learn and where to learn become just as important as what to learn. Invite learners to observe how you navigate ambiguity. For example, I recently interacted with a colleague on an unfamiliar case. She said, “Dr Wang, I don’t know much about malaria. Can you share with me what made you consider this diagnosis?” Additionally, admitting to learners when you have made an error not only clarifies their learning, but also role models continuous personal improvement.

By modeling humility by acknowledging our own limits, respecting our learners’ knowledge and experiences, and demonstrating how we manage uncertainty, we can enhance the learning environment and inspire our learners.

Doctor sentenced for unlawful prescriptions leading to five patient deaths

Darrel R. Rinehart, MD, was sentenced to 3 years in prison in June 2021 for unlawfully distributing controlled substances, primarily opioids, out of his clinic in Columbia, Tenn. Five of his patients who received prescriptions died of fatal overdoses within a year, according to the Indianapolis Star. Dr. Rinehart agreed to leave Tennessee to avoid punishment in that state before setting up his Indiana clinic.

Dr. Rinehart, 66, admitted to distributing Schedule II controlled substances to four different patients without legitimate medical purpose on 18 occasions between December 2014 and December 2015. He also admitted to knowingly distributing hydrocodone, also a Schedule II controlled substance, in January 2016 to a patient who did not have any health issues justifying the prescription. His medical license has been revoked. 
 

Judge approves $15 million settlement in patient’s sexual assault

An incapacitated woman at Hacienda Healthcare, a long-term care center in Phoenix, Ariz., gave birth in late 2018 after being raped by one of the nursing staff, according to Insurance Journal. In June 2021, a judge approved a $15 million settlement in a lawsuit by the woman’s parents against Phillip E. Gear Jr., MD, the woman’s caregiver for 26 years at the center. The woman had been in a vegetative state at Hacienda Healthcare since childhood, and the judge ruled that she had been the victim of numerous sexual assaults prior to the birth. 

The pregnancy was discovered when an employee was changing the garments of the then 29-year-old victim and saw that she was delivering a child. Employees told police they had no idea the woman was pregnant. Police have said that DNA from Nathan Sutherland, a licensed practical nurse who worked at Hacienda and has since given up his nursing license, matched a genetic sample taken from the woman’s son.

The woman’s parents, who care for her son, also sued the state of Arizona and another doctor, Thanh Nguyen, MD, who cared for their daughter. Arizona, which contracts with companies like Hacienda to provide services to people with developmental disabilities, settled last year for $7.5 million. Both Hacienda and Dr. Nguyen, who cared for the woman in the months before the birth, settled for undisclosed amounts.

The insurer for Dr. Gear, who died in late 2020, said it has no obligation to pay the amount, arguing that the doctor’s policy didn’t cover claims arising from a sexual act. The insurer also argued that Dr. Gear wasn’t the woman’s primary care physician when she gave birth and couldn’t be held responsible for sexual assault. 

The judge declared the $15 million settlement reasonable, concluding that Dr. Gear’s treatment of the woman had fallen below the standard of care, which included failing to examine her regularly and to diagnose her pregnancy. Requests by the woman’s mother to have exclusively female employees tend to her were not followed, as shown by medical records.
 

Doctor fired for contributing to suffering and death of prisoners

Washington’s prison system will pay $3.25 million and has fired the medical director of one of its facilities, stemming from the death of an inmate. 

John Kleutsch, a 57-year-old prisoner, died in late 2018 of septic shock, acute pancreatitis, and a perforated intestine caused by an improperly treated abdominal wound, according to the Seattle Times. A lawsuit filed by his wife, Julia Kleutsch, said that the staff offered him only Tylenol for his pain and that Julia Barnett, MD, the former prison medical director, refused to take him to a hospital.

Dr. Barnett, whose medical license has been indefinitely suspended, was fired in 2019 after an internal investigation found that her medical care and supervision contributed to the suffering and deaths of several men in the prison, including Mr. Kleutsch. 

Mr. Kleutsch, imprisoned for child molestation, was recovering from outpatient cancer surgery and sent back to the prison infirmary to recover. The lawsuit says that Mr. Kleutsch asked staff for help when his abdominal wound became excruciatingly painful, puffy, and oozing, and that at least one nurse asked Dr. Barnett to transfer him to a hospital, but she refused. Dr. Kleutsch’s causes of death were conditions never diagnosed at the prison.

Plaintiff attorney Marta O’Brien called the case “one of the worst medical malpractice cases I have encountered” and said it showed “a systemic failure” by the Department of Corrections.
 

SNF pays $11 million to resolve Medicare fraud allegations

SavaSeniorCare (Sava) and related entities agreed to pay $11.2 million in May 2021 to resolve allegations that they violated the False Claims Act by making their skilled nursing facilities (SNFs) bill Medicare for rehabilitation therapy services that were not reasonable, necessary, or skilled. The payment was also to resolve allegations that Sava billed the Medicare and Medicaid programs for substandard skilled nursing services, according to the U.S. Department of Justice. Sava is based in Georgia but owns and operates SNFs across the country.

The government filed a complaint against Sava in 2015, alleging that between October 2008 and September 2012, Sava intentionally submitted false claims for rehabilitation therapy services as a result of a systematic effort to increase its Medicare and Medicaid billings. The claim alleged that Sava exerted significant pressure on its SNFs to meet unrealistic financial goals, resulting in the provision of medically unreasonable, unnecessary, or unskilled services to Medicare patients. Sava also allegedly sought to increase its Medicare payments by delaying the discharge of patients from its facilities, even though the patients were medically ready to be discharged. 

Additionally, the government alleged that some of Sava’s nursing services failed to meet federal standards of care, including failing to have sufficient staffing at certain facilities, failing to follow appropriate pressure ulcer and falls protocols, and failing to appropriately administer medications. 

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

Doctor sentenced for unlawful prescriptions leading to five patient deaths

Darrel R. Rinehart, MD, was sentenced to 3 years in prison in June 2021 for unlawfully distributing controlled substances, primarily opioids, out of his clinic in Columbia, Tenn. Five of his patients who received prescriptions died of fatal overdoses within a year, according to the Indianapolis Star. Dr. Rinehart agreed to leave Tennessee to avoid punishment in that state before setting up his Indiana clinic.

Dr. Rinehart, 66, admitted to distributing Schedule II controlled substances to four different patients without legitimate medical purpose on 18 occasions between December 2014 and December 2015. He also admitted to knowingly distributing hydrocodone, also a Schedule II controlled substance, in January 2016 to a patient who did not have any health issues justifying the prescription. His medical license has been revoked. 
 

Judge approves $15 million settlement in patient’s sexual assault

An incapacitated woman at Hacienda Healthcare, a long-term care center in Phoenix, Ariz., gave birth in late 2018 after being raped by one of the nursing staff, according to Insurance Journal. In June 2021, a judge approved a $15 million settlement in a lawsuit by the woman’s parents against Phillip E. Gear Jr., MD, the woman’s caregiver for 26 years at the center. The woman had been in a vegetative state at Hacienda Healthcare since childhood, and the judge ruled that she had been the victim of numerous sexual assaults prior to the birth. 

The pregnancy was discovered when an employee was changing the garments of the then 29-year-old victim and saw that she was delivering a child. Employees told police they had no idea the woman was pregnant. Police have said that DNA from Nathan Sutherland, a licensed practical nurse who worked at Hacienda and has since given up his nursing license, matched a genetic sample taken from the woman’s son.

The woman’s parents, who care for her son, also sued the state of Arizona and another doctor, Thanh Nguyen, MD, who cared for their daughter. Arizona, which contracts with companies like Hacienda to provide services to people with developmental disabilities, settled last year for $7.5 million. Both Hacienda and Dr. Nguyen, who cared for the woman in the months before the birth, settled for undisclosed amounts.

The insurer for Dr. Gear, who died in late 2020, said it has no obligation to pay the amount, arguing that the doctor’s policy didn’t cover claims arising from a sexual act. The insurer also argued that Dr. Gear wasn’t the woman’s primary care physician when she gave birth and couldn’t be held responsible for sexual assault. 

The judge declared the $15 million settlement reasonable, concluding that Dr. Gear’s treatment of the woman had fallen below the standard of care, which included failing to examine her regularly and to diagnose her pregnancy. Requests by the woman’s mother to have exclusively female employees tend to her were not followed, as shown by medical records.
 

Doctor fired for contributing to suffering and death of prisoners

Washington’s prison system will pay $3.25 million and has fired the medical director of one of its facilities, stemming from the death of an inmate. 

John Kleutsch, a 57-year-old prisoner, died in late 2018 of septic shock, acute pancreatitis, and a perforated intestine caused by an improperly treated abdominal wound, according to the Seattle Times. A lawsuit filed by his wife, Julia Kleutsch, said that the staff offered him only Tylenol for his pain and that Julia Barnett, MD, the former prison medical director, refused to take him to a hospital.

Dr. Barnett, whose medical license has been indefinitely suspended, was fired in 2019 after an internal investigation found that her medical care and supervision contributed to the suffering and deaths of several men in the prison, including Mr. Kleutsch. 

Mr. Kleutsch, imprisoned for child molestation, was recovering from outpatient cancer surgery and sent back to the prison infirmary to recover. The lawsuit says that Mr. Kleutsch asked staff for help when his abdominal wound became excruciatingly painful, puffy, and oozing, and that at least one nurse asked Dr. Barnett to transfer him to a hospital, but she refused. Dr. Kleutsch’s causes of death were conditions never diagnosed at the prison.

Plaintiff attorney Marta O’Brien called the case “one of the worst medical malpractice cases I have encountered” and said it showed “a systemic failure” by the Department of Corrections.
 

SNF pays $11 million to resolve Medicare fraud allegations

SavaSeniorCare (Sava) and related entities agreed to pay $11.2 million in May 2021 to resolve allegations that they violated the False Claims Act by making their skilled nursing facilities (SNFs) bill Medicare for rehabilitation therapy services that were not reasonable, necessary, or skilled. The payment was also to resolve allegations that Sava billed the Medicare and Medicaid programs for substandard skilled nursing services, according to the U.S. Department of Justice. Sava is based in Georgia but owns and operates SNFs across the country.

The government filed a complaint against Sava in 2015, alleging that between October 2008 and September 2012, Sava intentionally submitted false claims for rehabilitation therapy services as a result of a systematic effort to increase its Medicare and Medicaid billings. The claim alleged that Sava exerted significant pressure on its SNFs to meet unrealistic financial goals, resulting in the provision of medically unreasonable, unnecessary, or unskilled services to Medicare patients. Sava also allegedly sought to increase its Medicare payments by delaying the discharge of patients from its facilities, even though the patients were medically ready to be discharged. 

Additionally, the government alleged that some of Sava’s nursing services failed to meet federal standards of care, including failing to have sufficient staffing at certain facilities, failing to follow appropriate pressure ulcer and falls protocols, and failing to appropriately administer medications. 

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

Doctor sentenced for unlawful prescriptions leading to five patient deaths

Darrel R. Rinehart, MD, was sentenced to 3 years in prison in June 2021 for unlawfully distributing controlled substances, primarily opioids, out of his clinic in Columbia, Tenn. Five of his patients who received prescriptions died of fatal overdoses within a year, according to the Indianapolis Star. Dr. Rinehart agreed to leave Tennessee to avoid punishment in that state before setting up his Indiana clinic.

Dr. Rinehart, 66, admitted to distributing Schedule II controlled substances to four different patients without legitimate medical purpose on 18 occasions between December 2014 and December 2015. He also admitted to knowingly distributing hydrocodone, also a Schedule II controlled substance, in January 2016 to a patient who did not have any health issues justifying the prescription. His medical license has been revoked. 
 

Judge approves $15 million settlement in patient’s sexual assault

An incapacitated woman at Hacienda Healthcare, a long-term care center in Phoenix, Ariz., gave birth in late 2018 after being raped by one of the nursing staff, according to Insurance Journal. In June 2021, a judge approved a $15 million settlement in a lawsuit by the woman’s parents against Phillip E. Gear Jr., MD, the woman’s caregiver for 26 years at the center. The woman had been in a vegetative state at Hacienda Healthcare since childhood, and the judge ruled that she had been the victim of numerous sexual assaults prior to the birth. 

The pregnancy was discovered when an employee was changing the garments of the then 29-year-old victim and saw that she was delivering a child. Employees told police they had no idea the woman was pregnant. Police have said that DNA from Nathan Sutherland, a licensed practical nurse who worked at Hacienda and has since given up his nursing license, matched a genetic sample taken from the woman’s son.

The woman’s parents, who care for her son, also sued the state of Arizona and another doctor, Thanh Nguyen, MD, who cared for their daughter. Arizona, which contracts with companies like Hacienda to provide services to people with developmental disabilities, settled last year for $7.5 million. Both Hacienda and Dr. Nguyen, who cared for the woman in the months before the birth, settled for undisclosed amounts.

The insurer for Dr. Gear, who died in late 2020, said it has no obligation to pay the amount, arguing that the doctor’s policy didn’t cover claims arising from a sexual act. The insurer also argued that Dr. Gear wasn’t the woman’s primary care physician when she gave birth and couldn’t be held responsible for sexual assault. 

The judge declared the $15 million settlement reasonable, concluding that Dr. Gear’s treatment of the woman had fallen below the standard of care, which included failing to examine her regularly and to diagnose her pregnancy. Requests by the woman’s mother to have exclusively female employees tend to her were not followed, as shown by medical records.
 

Doctor fired for contributing to suffering and death of prisoners

Washington’s prison system will pay $3.25 million and has fired the medical director of one of its facilities, stemming from the death of an inmate. 

John Kleutsch, a 57-year-old prisoner, died in late 2018 of septic shock, acute pancreatitis, and a perforated intestine caused by an improperly treated abdominal wound, according to the Seattle Times. A lawsuit filed by his wife, Julia Kleutsch, said that the staff offered him only Tylenol for his pain and that Julia Barnett, MD, the former prison medical director, refused to take him to a hospital.

Dr. Barnett, whose medical license has been indefinitely suspended, was fired in 2019 after an internal investigation found that her medical care and supervision contributed to the suffering and deaths of several men in the prison, including Mr. Kleutsch. 

Mr. Kleutsch, imprisoned for child molestation, was recovering from outpatient cancer surgery and sent back to the prison infirmary to recover. The lawsuit says that Mr. Kleutsch asked staff for help when his abdominal wound became excruciatingly painful, puffy, and oozing, and that at least one nurse asked Dr. Barnett to transfer him to a hospital, but she refused. Dr. Kleutsch’s causes of death were conditions never diagnosed at the prison.

Plaintiff attorney Marta O’Brien called the case “one of the worst medical malpractice cases I have encountered” and said it showed “a systemic failure” by the Department of Corrections.
 

SNF pays $11 million to resolve Medicare fraud allegations

SavaSeniorCare (Sava) and related entities agreed to pay $11.2 million in May 2021 to resolve allegations that they violated the False Claims Act by making their skilled nursing facilities (SNFs) bill Medicare for rehabilitation therapy services that were not reasonable, necessary, or skilled. The payment was also to resolve allegations that Sava billed the Medicare and Medicaid programs for substandard skilled nursing services, according to the U.S. Department of Justice. Sava is based in Georgia but owns and operates SNFs across the country.

The government filed a complaint against Sava in 2015, alleging that between October 2008 and September 2012, Sava intentionally submitted false claims for rehabilitation therapy services as a result of a systematic effort to increase its Medicare and Medicaid billings. The claim alleged that Sava exerted significant pressure on its SNFs to meet unrealistic financial goals, resulting in the provision of medically unreasonable, unnecessary, or unskilled services to Medicare patients. Sava also allegedly sought to increase its Medicare payments by delaying the discharge of patients from its facilities, even though the patients were medically ready to be discharged. 

Additionally, the government alleged that some of Sava’s nursing services failed to meet federal standards of care, including failing to have sufficient staffing at certain facilities, failing to follow appropriate pressure ulcer and falls protocols, and failing to appropriately administer medications. 

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

The same genetic variations may boost susceptibility to both severe COVID-19 and cannabis use disorder (CUD), a new study suggests. The research does not confirm a genetic link, but the lead author said the signs of an association are still “troubling.”

“Reducing cannabis use among heavy users may potentially provide protection against severe COVID-19 presentations,” Alexander S. Hatoum, PhD, a postdoctoral scholar at Washington University, St. Louis, said in an interview. “Outside of individual risk, these data also have important implications for policy regarding vaccination as well as treatment prioritization in an overly taxed medical system.”

The study was published in the journal Biological Psychiatry Global Open Science.

Dr. Hatoum and colleagues launched the study to gain insight into whether CUD might be a risk factor for severe COVID-19 presentations.

As defined by the DSM-5, people with CUD suffer from impairment or distress because of their cannabis use and meet at least 2 of 11 criteria over a 12-month period, such as cravings, cannabis tolerance, and withdrawal symptoms. According to a 2020 study that examined 2008-2016 data, 2.72% of children aged 12-17 showed signs of CUD, as did 1.23% of those aged over 26.

The primary reasons for hospitalization and death related to COVID-19 are respiratory symptoms. “And we have observed that genetic vulnerability to CUD is shared with respiratory disease, even after tobacco use is considered,” Dr. Hatoum said.

He and his colleagues examined data from genomewide association studies and searched for genetic correlations between CUD (14,080 cases, 343,726 controls) and COVID-19 hospitalization (9,373 cases, 1,197,256 controls). “Genetic vulnerability to COVID-19 was correlated with genetic liability to CUD (P = 1.33e^–6),” the researchers wrote. “This association remained when accounting for genetic liability to related risk factors and covariates (P = .012-.049).”

According to Dr. Hatoum, the researchers found inconclusive evidence that CUD might worsen COVID-19 cases. “We applied statistical causal models, which found an effect consistent with causality, but it was nonsignificant,” he said.

Despite the absence of causality, the study findings could prove useful for clinicians and policy makers.

“Those struggling with CUD may be prioritized for vaccination and vaccination boosters to mitigate their higher likelihood of a severe COVID-19 presentation,” Dr. Hatoum said. “When testing positive for COVID-19, they may also be prioritized for earlier treatment.”

The study authors also added that the findings “urge caution” in regard to the wave of U.S. states legalizing cannabis. “Our data suggest that heavy cannabis use, but not lifetime cannabis use, represents a risk factor for severe COVID-19 presentations,” Dr. Hatoum said.

In an interview, Danielle Dick, PhD, who was not involved with the study, said it applies “cutting-edge methods to an important research question” and offers a “hint” of a genetic risk factor that makes some people more likely to be hospitalized for COVID-19. However, “the study does not tell us what those underlying genetically influenced processes might be,” added Dr. Dick, professor of psychology, and human and molecular genetics at Virginia Commonwealth University, Richmond. “And it’s an important caveat to point out that the results from this study are limited in that they are based on data from people from European descent – so they can’t necessarily be applied to address the harm experienced by so many people of color from the COVID pandemic. That’s an unfortunate limitation.”

As for the idea that the study findings should prompt caution about marijuana legalization, Dr. Dick said it’s true that increased acceptability of drug use “increases the likelihood that individuals who are genetically vulnerable will develop problems. There is robust evidence of this.”

However, Dr. Dick said, “the legalization of marijuana is a complex topic because the health consequences aren’t the only consideration when it comes to legalization. The other side of the coin is the huge harm that has been caused to communities of color through marijuana criminalization. Legalization will hopefully lead to decreased harm on that front. So it’s a double-edged sword.”

Dr. Hatoum, his colleagues, and Dr. Dick reported no relevant disclosures.

The same genetic variations may boost susceptibility to both severe COVID-19 and cannabis use disorder (CUD), a new study suggests. The research does not confirm a genetic link, but the lead author said the signs of an association are still “troubling.”

“Reducing cannabis use among heavy users may potentially provide protection against severe COVID-19 presentations,” Alexander S. Hatoum, PhD, a postdoctoral scholar at Washington University, St. Louis, said in an interview. “Outside of individual risk, these data also have important implications for policy regarding vaccination as well as treatment prioritization in an overly taxed medical system.”

The study was published in the journal Biological Psychiatry Global Open Science.

Dr. Hatoum and colleagues launched the study to gain insight into whether CUD might be a risk factor for severe COVID-19 presentations.

As defined by the DSM-5, people with CUD suffer from impairment or distress because of their cannabis use and meet at least 2 of 11 criteria over a 12-month period, such as cravings, cannabis tolerance, and withdrawal symptoms. According to a 2020 study that examined 2008-2016 data, 2.72% of children aged 12-17 showed signs of CUD, as did 1.23% of those aged over 26.

The primary reasons for hospitalization and death related to COVID-19 are respiratory symptoms. “And we have observed that genetic vulnerability to CUD is shared with respiratory disease, even after tobacco use is considered,” Dr. Hatoum said.

He and his colleagues examined data from genomewide association studies and searched for genetic correlations between CUD (14,080 cases, 343,726 controls) and COVID-19 hospitalization (9,373 cases, 1,197,256 controls). “Genetic vulnerability to COVID-19 was correlated with genetic liability to CUD (P = 1.33e^–6),” the researchers wrote. “This association remained when accounting for genetic liability to related risk factors and covariates (P = .012-.049).”

According to Dr. Hatoum, the researchers found inconclusive evidence that CUD might worsen COVID-19 cases. “We applied statistical causal models, which found an effect consistent with causality, but it was nonsignificant,” he said.

Despite the absence of causality, the study findings could prove useful for clinicians and policy makers.

“Those struggling with CUD may be prioritized for vaccination and vaccination boosters to mitigate their higher likelihood of a severe COVID-19 presentation,” Dr. Hatoum said. “When testing positive for COVID-19, they may also be prioritized for earlier treatment.”

The study authors also added that the findings “urge caution” in regard to the wave of U.S. states legalizing cannabis. “Our data suggest that heavy cannabis use, but not lifetime cannabis use, represents a risk factor for severe COVID-19 presentations,” Dr. Hatoum said.

In an interview, Danielle Dick, PhD, who was not involved with the study, said it applies “cutting-edge methods to an important research question” and offers a “hint” of a genetic risk factor that makes some people more likely to be hospitalized for COVID-19. However, “the study does not tell us what those underlying genetically influenced processes might be,” added Dr. Dick, professor of psychology, and human and molecular genetics at Virginia Commonwealth University, Richmond. “And it’s an important caveat to point out that the results from this study are limited in that they are based on data from people from European descent – so they can’t necessarily be applied to address the harm experienced by so many people of color from the COVID pandemic. That’s an unfortunate limitation.”

As for the idea that the study findings should prompt caution about marijuana legalization, Dr. Dick said it’s true that increased acceptability of drug use “increases the likelihood that individuals who are genetically vulnerable will develop problems. There is robust evidence of this.”

However, Dr. Dick said, “the legalization of marijuana is a complex topic because the health consequences aren’t the only consideration when it comes to legalization. The other side of the coin is the huge harm that has been caused to communities of color through marijuana criminalization. Legalization will hopefully lead to decreased harm on that front. So it’s a double-edged sword.”

Dr. Hatoum, his colleagues, and Dr. Dick reported no relevant disclosures.

The same genetic variations may boost susceptibility to both severe COVID-19 and cannabis use disorder (CUD), a new study suggests. The research does not confirm a genetic link, but the lead author said the signs of an association are still “troubling.”

“Reducing cannabis use among heavy users may potentially provide protection against severe COVID-19 presentations,” Alexander S. Hatoum, PhD, a postdoctoral scholar at Washington University, St. Louis, said in an interview. “Outside of individual risk, these data also have important implications for policy regarding vaccination as well as treatment prioritization in an overly taxed medical system.”

The study was published in the journal Biological Psychiatry Global Open Science.

Dr. Hatoum and colleagues launched the study to gain insight into whether CUD might be a risk factor for severe COVID-19 presentations.

As defined by the DSM-5, people with CUD suffer from impairment or distress because of their cannabis use and meet at least 2 of 11 criteria over a 12-month period, such as cravings, cannabis tolerance, and withdrawal symptoms. According to a 2020 study that examined 2008-2016 data, 2.72% of children aged 12-17 showed signs of CUD, as did 1.23% of those aged over 26.

The primary reasons for hospitalization and death related to COVID-19 are respiratory symptoms. “And we have observed that genetic vulnerability to CUD is shared with respiratory disease, even after tobacco use is considered,” Dr. Hatoum said.

He and his colleagues examined data from genomewide association studies and searched for genetic correlations between CUD (14,080 cases, 343,726 controls) and COVID-19 hospitalization (9,373 cases, 1,197,256 controls). “Genetic vulnerability to COVID-19 was correlated with genetic liability to CUD (P = 1.33e^–6),” the researchers wrote. “This association remained when accounting for genetic liability to related risk factors and covariates (P = .012-.049).”

According to Dr. Hatoum, the researchers found inconclusive evidence that CUD might worsen COVID-19 cases. “We applied statistical causal models, which found an effect consistent with causality, but it was nonsignificant,” he said.

Despite the absence of causality, the study findings could prove useful for clinicians and policy makers.

“Those struggling with CUD may be prioritized for vaccination and vaccination boosters to mitigate their higher likelihood of a severe COVID-19 presentation,” Dr. Hatoum said. “When testing positive for COVID-19, they may also be prioritized for earlier treatment.”

The study authors also added that the findings “urge caution” in regard to the wave of U.S. states legalizing cannabis. “Our data suggest that heavy cannabis use, but not lifetime cannabis use, represents a risk factor for severe COVID-19 presentations,” Dr. Hatoum said.

In an interview, Danielle Dick, PhD, who was not involved with the study, said it applies “cutting-edge methods to an important research question” and offers a “hint” of a genetic risk factor that makes some people more likely to be hospitalized for COVID-19. However, “the study does not tell us what those underlying genetically influenced processes might be,” added Dr. Dick, professor of psychology, and human and molecular genetics at Virginia Commonwealth University, Richmond. “And it’s an important caveat to point out that the results from this study are limited in that they are based on data from people from European descent – so they can’t necessarily be applied to address the harm experienced by so many people of color from the COVID pandemic. That’s an unfortunate limitation.”

As for the idea that the study findings should prompt caution about marijuana legalization, Dr. Dick said it’s true that increased acceptability of drug use “increases the likelihood that individuals who are genetically vulnerable will develop problems. There is robust evidence of this.”

However, Dr. Dick said, “the legalization of marijuana is a complex topic because the health consequences aren’t the only consideration when it comes to legalization. The other side of the coin is the huge harm that has been caused to communities of color through marijuana criminalization. Legalization will hopefully lead to decreased harm on that front. So it’s a double-edged sword.”

Dr. Hatoum, his colleagues, and Dr. Dick reported no relevant disclosures.

Death from COVID-19 was not more likely among patients with inflammatory bowel disease (IBD) who had COVID-19 who developed new GI symptoms after becoming infected, according to international registry data from nearly 3,000 adults.

Although GI symptoms may arise in the general population of COVID-19 patients, data on the association between GI symptoms and COVID-19 in patients with IBD are limited, as are data on the association of GI symptoms and COVID-19 outcomes in this population, Ryan C. Ungaro, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote.

In a study published in Inflammatory Bowel Diseases, the researchers identified 2,917 adults with IBD who developed COVID-19 using the Surveillance Epidemiology of Coronavirus Under Research Exclusion in Inflammatory Bowel Disease (SECURE-IBD) database, a global registry created to understand COVID-19 outcomes in IBD patients.

The researchers recorded all new GI symptoms experienced by the patients while they were infected with COVID-19. Overall, 764 (26.2%) experienced new GI symptoms and 2,153 did not. The most common symptom was diarrhea, reported by 80% of the patients, followed by abdominal pain in 34%. Nausea and vomiting were reported by 24% and 12%, respectively, of all patients.

The average age of the patients was 43 years for those with no new GI symptoms and 40 for those without new GI symptoms; overall, approximately half were women and approximately three-quarters were White. Overall, 50% of those with new GI symptoms were in remission, as was the case for 58.4% of those without.

IBD patients who developed new GI symptoms were significantly more likely to be women, of Asian race, older, or have at least one comorbidity.

The researchers found no difference in new GI symptoms in patients with Crohn’s disease and ulcerative colitis. “Patients on any medication – but in particular [tumor necrosis factor] antagonist monotherapy – were less likely to report new GI symptoms.” they wrote.

Although IBD patients with new GI symptoms were significantly more likely than were those without new GI symptoms to be hospitalized for COVID-19 in bivariate analyses (31.4% vs. 19.2%; P < .001), they were not more likely to need a ventilator or intensive care (5.8% vs. 4.6%; P < .18). In a multivariate analysis, IBD patients with new GI symptoms had no greater risk of death from COVID-19 than did those without new GI symptoms (adjusted odds ratio, 0.72; 95% confidence interval, 0.38-1.36).

The new-onset GI symptoms common to IBD patients with COVID-19 are not likely caused by underlying disease activity, given the number of patients in remission who reported new GI symptoms, the researchers wrote.

The study findings were limited by several factors including the retrospective design, potential reporting bias, and reliance on physician global assessment for disease assessment, the researchers noted. However, the results were strengthened by the large sample size, by the ability to assess GI symptoms before and after COVID-19, and by the evaluation of GI symptoms and COVID-19 outcomes.

“In summary, new GI symptoms are common in IBD patients with COVID-19 and are not associated with an increased risk of death due to COVID-19,” the researchers concluded. “Our findings suggest that an increase in GI symptoms in IBD patients should prompt consideration of a COVID-19 diagnosis.”
 

Data to guide clinical care

“There are several potential causes for common GI symptoms, such as diarrhea and abdominal pain, among patients with IBD,” Shirley Cohen-Mekelburg, MD, of the University of Michigan, Ann Arbor, said in an interview. “These can be the initial presentation of an IBD flare, a noninflammatory cause such as irritable bowel syndrome, small intestinal bacterial overgrowth, or an infection such as Clostridioides difficile or SARS-CoV-2. Each of these diagnoses require different treatments. An IBD flare may require escalation of immunosuppressive medications such as biologics or corticosteroids, which can cause harm in the context of an untreated infection. Therefore, any guidance that will increase health care providers’ awareness of the possible causes of similar GI symptoms is important in caring for our patients with IBD. This is especially true in context of a newer entity such as COVID-19 with which we are overall less familiar.”

Dr. Cohen-Meckelburg said the lack of association between GI symptoms and death in IBD is reassuring. “It is interesting to note that GI symptoms, and particularly new diarrhea, were very common among patients with IBD and COVID-19.

“Health care providers who treat patients with IBD should have a high-index of suspicion for SARS-CoV-2 infections when patients with IBD present with GI symptoms,” said Dr. Cohen-Meckelburg. “The data from the current study may help us to consider standard testing to rule out COVID-19 as an alternative diagnosis when considering whether to treat patients with IBD who develop new GI symptoms for an IBD flare. This would be similar to how we currently test for C. difficile and other enteric infections before treating IBD flares.

“Every study has its limitations, which need to be considered in interpreting findings,” Dr. Cohen-Meckelburg noted . “SECURE-IBD has provided great insight into COVID-19 infections among patients with IBD. However, the registry relies on individuals reporting cases, so there is the potential for underreporting, particularly with less symptomatic or subclinical cases.”

The study was supported in part by the Helmsley Charitable Trust with additional funding provided by Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arenapharm. Lead author Dr. Ungaro disclosed serving as an advisory board member or consultant for AbbVie, Bristol-Myers Squibb, Janssen, Eli Lilly, Pfizer, and Takeda and research support from AbbVie, Boehringer Ingelheim, and Pfizer. Other coauthors disclosed similar relationships with other pharmaceutical companies. Dr. Cohen-Mekelburg had no financial conflicts to disclose.

Death from COVID-19 was not more likely among patients with inflammatory bowel disease (IBD) who had COVID-19 who developed new GI symptoms after becoming infected, according to international registry data from nearly 3,000 adults.

Although GI symptoms may arise in the general population of COVID-19 patients, data on the association between GI symptoms and COVID-19 in patients with IBD are limited, as are data on the association of GI symptoms and COVID-19 outcomes in this population, Ryan C. Ungaro, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote.

In a study published in Inflammatory Bowel Diseases, the researchers identified 2,917 adults with IBD who developed COVID-19 using the Surveillance Epidemiology of Coronavirus Under Research Exclusion in Inflammatory Bowel Disease (SECURE-IBD) database, a global registry created to understand COVID-19 outcomes in IBD patients.

The researchers recorded all new GI symptoms experienced by the patients while they were infected with COVID-19. Overall, 764 (26.2%) experienced new GI symptoms and 2,153 did not. The most common symptom was diarrhea, reported by 80% of the patients, followed by abdominal pain in 34%. Nausea and vomiting were reported by 24% and 12%, respectively, of all patients.

The average age of the patients was 43 years for those with no new GI symptoms and 40 for those without new GI symptoms; overall, approximately half were women and approximately three-quarters were White. Overall, 50% of those with new GI symptoms were in remission, as was the case for 58.4% of those without.

IBD patients who developed new GI symptoms were significantly more likely to be women, of Asian race, older, or have at least one comorbidity.

The researchers found no difference in new GI symptoms in patients with Crohn’s disease and ulcerative colitis. “Patients on any medication – but in particular [tumor necrosis factor] antagonist monotherapy – were less likely to report new GI symptoms.” they wrote.

Although IBD patients with new GI symptoms were significantly more likely than were those without new GI symptoms to be hospitalized for COVID-19 in bivariate analyses (31.4% vs. 19.2%; P < .001), they were not more likely to need a ventilator or intensive care (5.8% vs. 4.6%; P < .18). In a multivariate analysis, IBD patients with new GI symptoms had no greater risk of death from COVID-19 than did those without new GI symptoms (adjusted odds ratio, 0.72; 95% confidence interval, 0.38-1.36).

The new-onset GI symptoms common to IBD patients with COVID-19 are not likely caused by underlying disease activity, given the number of patients in remission who reported new GI symptoms, the researchers wrote.

The study findings were limited by several factors including the retrospective design, potential reporting bias, and reliance on physician global assessment for disease assessment, the researchers noted. However, the results were strengthened by the large sample size, by the ability to assess GI symptoms before and after COVID-19, and by the evaluation of GI symptoms and COVID-19 outcomes.

“In summary, new GI symptoms are common in IBD patients with COVID-19 and are not associated with an increased risk of death due to COVID-19,” the researchers concluded. “Our findings suggest that an increase in GI symptoms in IBD patients should prompt consideration of a COVID-19 diagnosis.”
 

Data to guide clinical care

“There are several potential causes for common GI symptoms, such as diarrhea and abdominal pain, among patients with IBD,” Shirley Cohen-Mekelburg, MD, of the University of Michigan, Ann Arbor, said in an interview. “These can be the initial presentation of an IBD flare, a noninflammatory cause such as irritable bowel syndrome, small intestinal bacterial overgrowth, or an infection such as Clostridioides difficile or SARS-CoV-2. Each of these diagnoses require different treatments. An IBD flare may require escalation of immunosuppressive medications such as biologics or corticosteroids, which can cause harm in the context of an untreated infection. Therefore, any guidance that will increase health care providers’ awareness of the possible causes of similar GI symptoms is important in caring for our patients with IBD. This is especially true in context of a newer entity such as COVID-19 with which we are overall less familiar.”

Dr. Cohen-Meckelburg said the lack of association between GI symptoms and death in IBD is reassuring. “It is interesting to note that GI symptoms, and particularly new diarrhea, were very common among patients with IBD and COVID-19.

“Health care providers who treat patients with IBD should have a high-index of suspicion for SARS-CoV-2 infections when patients with IBD present with GI symptoms,” said Dr. Cohen-Meckelburg. “The data from the current study may help us to consider standard testing to rule out COVID-19 as an alternative diagnosis when considering whether to treat patients with IBD who develop new GI symptoms for an IBD flare. This would be similar to how we currently test for C. difficile and other enteric infections before treating IBD flares.

“Every study has its limitations, which need to be considered in interpreting findings,” Dr. Cohen-Meckelburg noted . “SECURE-IBD has provided great insight into COVID-19 infections among patients with IBD. However, the registry relies on individuals reporting cases, so there is the potential for underreporting, particularly with less symptomatic or subclinical cases.”

The study was supported in part by the Helmsley Charitable Trust with additional funding provided by Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arenapharm. Lead author Dr. Ungaro disclosed serving as an advisory board member or consultant for AbbVie, Bristol-Myers Squibb, Janssen, Eli Lilly, Pfizer, and Takeda and research support from AbbVie, Boehringer Ingelheim, and Pfizer. Other coauthors disclosed similar relationships with other pharmaceutical companies. Dr. Cohen-Mekelburg had no financial conflicts to disclose.

Death from COVID-19 was not more likely among patients with inflammatory bowel disease (IBD) who had COVID-19 who developed new GI symptoms after becoming infected, according to international registry data from nearly 3,000 adults.

Although GI symptoms may arise in the general population of COVID-19 patients, data on the association between GI symptoms and COVID-19 in patients with IBD are limited, as are data on the association of GI symptoms and COVID-19 outcomes in this population, Ryan C. Ungaro, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote.

In a study published in Inflammatory Bowel Diseases, the researchers identified 2,917 adults with IBD who developed COVID-19 using the Surveillance Epidemiology of Coronavirus Under Research Exclusion in Inflammatory Bowel Disease (SECURE-IBD) database, a global registry created to understand COVID-19 outcomes in IBD patients.

The researchers recorded all new GI symptoms experienced by the patients while they were infected with COVID-19. Overall, 764 (26.2%) experienced new GI symptoms and 2,153 did not. The most common symptom was diarrhea, reported by 80% of the patients, followed by abdominal pain in 34%. Nausea and vomiting were reported by 24% and 12%, respectively, of all patients.

The average age of the patients was 43 years for those with no new GI symptoms and 40 for those without new GI symptoms; overall, approximately half were women and approximately three-quarters were White. Overall, 50% of those with new GI symptoms were in remission, as was the case for 58.4% of those without.

IBD patients who developed new GI symptoms were significantly more likely to be women, of Asian race, older, or have at least one comorbidity.

The researchers found no difference in new GI symptoms in patients with Crohn’s disease and ulcerative colitis. “Patients on any medication – but in particular [tumor necrosis factor] antagonist monotherapy – were less likely to report new GI symptoms.” they wrote.

Although IBD patients with new GI symptoms were significantly more likely than were those without new GI symptoms to be hospitalized for COVID-19 in bivariate analyses (31.4% vs. 19.2%; P < .001), they were not more likely to need a ventilator or intensive care (5.8% vs. 4.6%; P < .18). In a multivariate analysis, IBD patients with new GI symptoms had no greater risk of death from COVID-19 than did those without new GI symptoms (adjusted odds ratio, 0.72; 95% confidence interval, 0.38-1.36).

The new-onset GI symptoms common to IBD patients with COVID-19 are not likely caused by underlying disease activity, given the number of patients in remission who reported new GI symptoms, the researchers wrote.

The study findings were limited by several factors including the retrospective design, potential reporting bias, and reliance on physician global assessment for disease assessment, the researchers noted. However, the results were strengthened by the large sample size, by the ability to assess GI symptoms before and after COVID-19, and by the evaluation of GI symptoms and COVID-19 outcomes.

“In summary, new GI symptoms are common in IBD patients with COVID-19 and are not associated with an increased risk of death due to COVID-19,” the researchers concluded. “Our findings suggest that an increase in GI symptoms in IBD patients should prompt consideration of a COVID-19 diagnosis.”
 

Data to guide clinical care

“There are several potential causes for common GI symptoms, such as diarrhea and abdominal pain, among patients with IBD,” Shirley Cohen-Mekelburg, MD, of the University of Michigan, Ann Arbor, said in an interview. “These can be the initial presentation of an IBD flare, a noninflammatory cause such as irritable bowel syndrome, small intestinal bacterial overgrowth, or an infection such as Clostridioides difficile or SARS-CoV-2. Each of these diagnoses require different treatments. An IBD flare may require escalation of immunosuppressive medications such as biologics or corticosteroids, which can cause harm in the context of an untreated infection. Therefore, any guidance that will increase health care providers’ awareness of the possible causes of similar GI symptoms is important in caring for our patients with IBD. This is especially true in context of a newer entity such as COVID-19 with which we are overall less familiar.”

Dr. Cohen-Meckelburg said the lack of association between GI symptoms and death in IBD is reassuring. “It is interesting to note that GI symptoms, and particularly new diarrhea, were very common among patients with IBD and COVID-19.

“Health care providers who treat patients with IBD should have a high-index of suspicion for SARS-CoV-2 infections when patients with IBD present with GI symptoms,” said Dr. Cohen-Meckelburg. “The data from the current study may help us to consider standard testing to rule out COVID-19 as an alternative diagnosis when considering whether to treat patients with IBD who develop new GI symptoms for an IBD flare. This would be similar to how we currently test for C. difficile and other enteric infections before treating IBD flares.

“Every study has its limitations, which need to be considered in interpreting findings,” Dr. Cohen-Meckelburg noted . “SECURE-IBD has provided great insight into COVID-19 infections among patients with IBD. However, the registry relies on individuals reporting cases, so there is the potential for underreporting, particularly with less symptomatic or subclinical cases.”

The study was supported in part by the Helmsley Charitable Trust with additional funding provided by Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arenapharm. Lead author Dr. Ungaro disclosed serving as an advisory board member or consultant for AbbVie, Bristol-Myers Squibb, Janssen, Eli Lilly, Pfizer, and Takeda and research support from AbbVie, Boehringer Ingelheim, and Pfizer. Other coauthors disclosed similar relationships with other pharmaceutical companies. Dr. Cohen-Mekelburg had no financial conflicts to disclose.

Since the reversal of the Medicare exclusion in 2014, the rates of gender-affirming surgery have increased markedly in the United States.¹ Gender-affirming mastectomy, otherwise known as “top surgery,” is one of the more commonly performed procedures; with 97% of patients having either undergone or expressed desire for the surgery.² The goals of this procedure are to remove all visible breast tissue and reconstruct the chest wall so it is more masculine in appearance. For transmasculine and nonbinary patients, this procedure is associated with significant improvements in mental health and quality of life.^3,4 While the mastectomy procedure is often performed by plastic surgeons, patients will see an ob.gyn. in the preoperative or postoperative period. Ob.gyns. should have a general understanding of the procedure, but most importantly know how to screen for breast cancer in patients who have undergone a gender-affirming mastectomy.

Providers will likely encounter transmasculine or nonbinary patients during annual screening examinations or for a preoperative exam. If a patient is seeking a preoperative risk assessment prior to undergoing a gender-affirming mastectomy, assessing a patient’s risk status for breast cancer is paramount. While testosterone therapy is no longer a prerequisite for gender-affirming mastectomies, documenting hormone use, age at initiation, and dosage is important.⁵ The overall effects of testosterone on breast tissue are inconsistent. However, studies have demonstrated that patients taking testosterone are not at an increased risk of breast cancer secondary to testosterone use.^5-7 Patients should be asked about a personal of family history of breast cancer, breast surgery, history of prior breast biopsies, parity, age at menarche, smoking status, and breastfeeding history if applicable. Patients with high-risk mutations or a strong family history of breast cancer should be referred to genetic counselors, surgical oncologists, and possibly undergo genetic testing.⁸ Before an examination, providers should counsel patients about the nature of the examination and use gender-neutral language such as “chest” to avoid exacerbating gender dysphoria.

It is important to educate transmasculine patients about their risk for the development of breast cancer after mastectomy. Larger-scale, population-based studies of breast cancer in the transgender population have reported an incidence of 5.9 per 100,000 patients-years and an overall incidence comparable to cisgender men in age-standardized national samples.^5-7 Unfortunately, data on the rates of breast cancer in transmasculine patients after gender-affirming mastectomy are limited, which makes defining postoperative guidelines challenging. Additionally, the amount of residual breast tissue remaining varies based on the surgeon and technique.

Several techniques are described for mastectomy procedures with differences that can affect the amount of residual breast tissue. The most common type of gender-affirming mastectomy is the double incision. With this procedure, the nipple-areolar complex is reduced in size, removed, and thinned to improve graft take. Dissection is then carried to the level of the breast capsule and the breast tissue and axillary tail are removed en bloc.⁵ During the dissection, the subcutaneous fat is left on the skin flap to provide appropriate contour and to avoid creating a concave-appearing chest wall. Prior to closure, the superior and inferior flaps are inspected for any visible residual breast tissue, which is removed if needed. In a circumareolar mastectomy, the nipple-areolar complex is also reduced but is preserved on a 1- to 1.5-cm-thick pedicle to maintain perfusion.⁵ The mastectomy is performed through an inferior periareolar incision and all visible breast tissue and the axillary tail are removed. Breast tissue specimens are sent for pathologic evaluation at the end of the procedure.

Following gender-affirming mastectomy, there is limited evidence to guide screening. During the patient visit, the provider should obtain a thorough history regarding mastectomy type, and if unknown, attempt to acquire the operative report detailing the procedure. For low-risk patients who undergo a subcutaneous mastectomy such as the double incision or circumareolar technique, screening mammography is not indicated nor is it technically feasible.⁹ For patients with a high-risk genetic mutation or a strong family history of breast cancer, monitoring with alternative modalities such as breast ultrasound or breast MRI may be beneficial, although there is no evidence to currently support this suggestion. Given the variety of surgical techniques of breast tissue removal, it is difficult to develop strong evidence-based guidelines. Annual chest wall examinations have been suggested as a screening modality; however, the clinical utility of clinical breast and chest exams has been debated and is no longer recommended as a screening method in cisgender patients.⁹ Clinicians can promote chest self-awareness and discuss the possibility of breast cancer in postmastectomy patients at annual examination visits. As research continues to resolve some of these unknowns, it is important that patients are informed of these areas of ambiguity and updated regarding any changes in screening recommendations.¹⁰

Dr. Brandt is an ob.gyn. and fellowship-trained gender affirming surgeon in West Reading, Pa.

References

1. American Society of Plastic Surgeons. 2018 plastic surgery statistics report. https://www.plasticsurgery.org/documents/News/Statistics/2018/plastic-surgery-statistics-full-report-2018.pdf. Accessed Aug. 20, 2021.

2. James SE et al. The report of the 2015 U.S. Transgender survey. Washington, D.C.: National Center for Transgender Equality, 2016.

3. Agarwal CA et al. J Plast Reconstr Aesthet Surg. 2018;71:651-7.

4. Poudrier G et al. Plast Reconstr Surg. 2018;80:679-83.

5. Salibian AA et al. Plast Reconstr Surg. 2020;147:213e-21e.

6. Gooren LJ et al. J Sex Med. 2013;10:3129-34.

7. Brown GR and Jones KT. Breast Cancer Res Treat. 2015;149:191-8.

8. Deutsch MF et al. Semin Reprod Med. 2017;35:434-41.

9. Phillips J et al. AJR Am J Roentgenol. 2014;202:1149-59.

10. Smith RA et al. CA Cancer J Clin. 2018;68:297-316.

Since the reversal of the Medicare exclusion in 2014, the rates of gender-affirming surgery have increased markedly in the United States.¹ Gender-affirming mastectomy, otherwise known as “top surgery,” is one of the more commonly performed procedures; with 97% of patients having either undergone or expressed desire for the surgery.² The goals of this procedure are to remove all visible breast tissue and reconstruct the chest wall so it is more masculine in appearance. For transmasculine and nonbinary patients, this procedure is associated with significant improvements in mental health and quality of life.^3,4 While the mastectomy procedure is often performed by plastic surgeons, patients will see an ob.gyn. in the preoperative or postoperative period. Ob.gyns. should have a general understanding of the procedure, but most importantly know how to screen for breast cancer in patients who have undergone a gender-affirming mastectomy.

Providers will likely encounter transmasculine or nonbinary patients during annual screening examinations or for a preoperative exam. If a patient is seeking a preoperative risk assessment prior to undergoing a gender-affirming mastectomy, assessing a patient’s risk status for breast cancer is paramount. While testosterone therapy is no longer a prerequisite for gender-affirming mastectomies, documenting hormone use, age at initiation, and dosage is important.⁵ The overall effects of testosterone on breast tissue are inconsistent. However, studies have demonstrated that patients taking testosterone are not at an increased risk of breast cancer secondary to testosterone use.^5-7 Patients should be asked about a personal of family history of breast cancer, breast surgery, history of prior breast biopsies, parity, age at menarche, smoking status, and breastfeeding history if applicable. Patients with high-risk mutations or a strong family history of breast cancer should be referred to genetic counselors, surgical oncologists, and possibly undergo genetic testing.⁸ Before an examination, providers should counsel patients about the nature of the examination and use gender-neutral language such as “chest” to avoid exacerbating gender dysphoria.

It is important to educate transmasculine patients about their risk for the development of breast cancer after mastectomy. Larger-scale, population-based studies of breast cancer in the transgender population have reported an incidence of 5.9 per 100,000 patients-years and an overall incidence comparable to cisgender men in age-standardized national samples.^5-7 Unfortunately, data on the rates of breast cancer in transmasculine patients after gender-affirming mastectomy are limited, which makes defining postoperative guidelines challenging. Additionally, the amount of residual breast tissue remaining varies based on the surgeon and technique.

Several techniques are described for mastectomy procedures with differences that can affect the amount of residual breast tissue. The most common type of gender-affirming mastectomy is the double incision. With this procedure, the nipple-areolar complex is reduced in size, removed, and thinned to improve graft take. Dissection is then carried to the level of the breast capsule and the breast tissue and axillary tail are removed en bloc.⁵ During the dissection, the subcutaneous fat is left on the skin flap to provide appropriate contour and to avoid creating a concave-appearing chest wall. Prior to closure, the superior and inferior flaps are inspected for any visible residual breast tissue, which is removed if needed. In a circumareolar mastectomy, the nipple-areolar complex is also reduced but is preserved on a 1- to 1.5-cm-thick pedicle to maintain perfusion.⁵ The mastectomy is performed through an inferior periareolar incision and all visible breast tissue and the axillary tail are removed. Breast tissue specimens are sent for pathologic evaluation at the end of the procedure.

Following gender-affirming mastectomy, there is limited evidence to guide screening. During the patient visit, the provider should obtain a thorough history regarding mastectomy type, and if unknown, attempt to acquire the operative report detailing the procedure. For low-risk patients who undergo a subcutaneous mastectomy such as the double incision or circumareolar technique, screening mammography is not indicated nor is it technically feasible.⁹ For patients with a high-risk genetic mutation or a strong family history of breast cancer, monitoring with alternative modalities such as breast ultrasound or breast MRI may be beneficial, although there is no evidence to currently support this suggestion. Given the variety of surgical techniques of breast tissue removal, it is difficult to develop strong evidence-based guidelines. Annual chest wall examinations have been suggested as a screening modality; however, the clinical utility of clinical breast and chest exams has been debated and is no longer recommended as a screening method in cisgender patients.⁹ Clinicians can promote chest self-awareness and discuss the possibility of breast cancer in postmastectomy patients at annual examination visits. As research continues to resolve some of these unknowns, it is important that patients are informed of these areas of ambiguity and updated regarding any changes in screening recommendations.¹⁰

Dr. Brandt is an ob.gyn. and fellowship-trained gender affirming surgeon in West Reading, Pa.

References

1. American Society of Plastic Surgeons. 2018 plastic surgery statistics report. https://www.plasticsurgery.org/documents/News/Statistics/2018/plastic-surgery-statistics-full-report-2018.pdf. Accessed Aug. 20, 2021.

2. James SE et al. The report of the 2015 U.S. Transgender survey. Washington, D.C.: National Center for Transgender Equality, 2016.

3. Agarwal CA et al. J Plast Reconstr Aesthet Surg. 2018;71:651-7.

4. Poudrier G et al. Plast Reconstr Surg. 2018;80:679-83.

5. Salibian AA et al. Plast Reconstr Surg. 2020;147:213e-21e.

6. Gooren LJ et al. J Sex Med. 2013;10:3129-34.

7. Brown GR and Jones KT. Breast Cancer Res Treat. 2015;149:191-8.

8. Deutsch MF et al. Semin Reprod Med. 2017;35:434-41.

9. Phillips J et al. AJR Am J Roentgenol. 2014;202:1149-59.

10. Smith RA et al. CA Cancer J Clin. 2018;68:297-316.

Since the reversal of the Medicare exclusion in 2014, the rates of gender-affirming surgery have increased markedly in the United States.¹ Gender-affirming mastectomy, otherwise known as “top surgery,” is one of the more commonly performed procedures; with 97% of patients having either undergone or expressed desire for the surgery.² The goals of this procedure are to remove all visible breast tissue and reconstruct the chest wall so it is more masculine in appearance. For transmasculine and nonbinary patients, this procedure is associated with significant improvements in mental health and quality of life.^3,4 While the mastectomy procedure is often performed by plastic surgeons, patients will see an ob.gyn. in the preoperative or postoperative period. Ob.gyns. should have a general understanding of the procedure, but most importantly know how to screen for breast cancer in patients who have undergone a gender-affirming mastectomy.

Providers will likely encounter transmasculine or nonbinary patients during annual screening examinations or for a preoperative exam. If a patient is seeking a preoperative risk assessment prior to undergoing a gender-affirming mastectomy, assessing a patient’s risk status for breast cancer is paramount. While testosterone therapy is no longer a prerequisite for gender-affirming mastectomies, documenting hormone use, age at initiation, and dosage is important.⁵ The overall effects of testosterone on breast tissue are inconsistent. However, studies have demonstrated that patients taking testosterone are not at an increased risk of breast cancer secondary to testosterone use.^5-7 Patients should be asked about a personal of family history of breast cancer, breast surgery, history of prior breast biopsies, parity, age at menarche, smoking status, and breastfeeding history if applicable. Patients with high-risk mutations or a strong family history of breast cancer should be referred to genetic counselors, surgical oncologists, and possibly undergo genetic testing.⁸ Before an examination, providers should counsel patients about the nature of the examination and use gender-neutral language such as “chest” to avoid exacerbating gender dysphoria.

It is important to educate transmasculine patients about their risk for the development of breast cancer after mastectomy. Larger-scale, population-based studies of breast cancer in the transgender population have reported an incidence of 5.9 per 100,000 patients-years and an overall incidence comparable to cisgender men in age-standardized national samples.^5-7 Unfortunately, data on the rates of breast cancer in transmasculine patients after gender-affirming mastectomy are limited, which makes defining postoperative guidelines challenging. Additionally, the amount of residual breast tissue remaining varies based on the surgeon and technique.

Several techniques are described for mastectomy procedures with differences that can affect the amount of residual breast tissue. The most common type of gender-affirming mastectomy is the double incision. With this procedure, the nipple-areolar complex is reduced in size, removed, and thinned to improve graft take. Dissection is then carried to the level of the breast capsule and the breast tissue and axillary tail are removed en bloc.⁵ During the dissection, the subcutaneous fat is left on the skin flap to provide appropriate contour and to avoid creating a concave-appearing chest wall. Prior to closure, the superior and inferior flaps are inspected for any visible residual breast tissue, which is removed if needed. In a circumareolar mastectomy, the nipple-areolar complex is also reduced but is preserved on a 1- to 1.5-cm-thick pedicle to maintain perfusion.⁵ The mastectomy is performed through an inferior periareolar incision and all visible breast tissue and the axillary tail are removed. Breast tissue specimens are sent for pathologic evaluation at the end of the procedure.

Following gender-affirming mastectomy, there is limited evidence to guide screening. During the patient visit, the provider should obtain a thorough history regarding mastectomy type, and if unknown, attempt to acquire the operative report detailing the procedure. For low-risk patients who undergo a subcutaneous mastectomy such as the double incision or circumareolar technique, screening mammography is not indicated nor is it technically feasible.⁹ For patients with a high-risk genetic mutation or a strong family history of breast cancer, monitoring with alternative modalities such as breast ultrasound or breast MRI may be beneficial, although there is no evidence to currently support this suggestion. Given the variety of surgical techniques of breast tissue removal, it is difficult to develop strong evidence-based guidelines. Annual chest wall examinations have been suggested as a screening modality; however, the clinical utility of clinical breast and chest exams has been debated and is no longer recommended as a screening method in cisgender patients.⁹ Clinicians can promote chest self-awareness and discuss the possibility of breast cancer in postmastectomy patients at annual examination visits. As research continues to resolve some of these unknowns, it is important that patients are informed of these areas of ambiguity and updated regarding any changes in screening recommendations.¹⁰

Dr. Brandt is an ob.gyn. and fellowship-trained gender affirming surgeon in West Reading, Pa.

References

1. American Society of Plastic Surgeons. 2018 plastic surgery statistics report. https://www.plasticsurgery.org/documents/News/Statistics/2018/plastic-surgery-statistics-full-report-2018.pdf. Accessed Aug. 20, 2021.

2. James SE et al. The report of the 2015 U.S. Transgender survey. Washington, D.C.: National Center for Transgender Equality, 2016.

3. Agarwal CA et al. J Plast Reconstr Aesthet Surg. 2018;71:651-7.

4. Poudrier G et al. Plast Reconstr Surg. 2018;80:679-83.

5. Salibian AA et al. Plast Reconstr Surg. 2020;147:213e-21e.

6. Gooren LJ et al. J Sex Med. 2013;10:3129-34.

7. Brown GR and Jones KT. Breast Cancer Res Treat. 2015;149:191-8.

8. Deutsch MF et al. Semin Reprod Med. 2017;35:434-41.

9. Phillips J et al. AJR Am J Roentgenol. 2014;202:1149-59.

10. Smith RA et al. CA Cancer J Clin. 2018;68:297-316.