MDedge Emergency Medicine

A new meta-analysis has shown that SGLT2 inhibitors do not lead to lower 28-day all-cause mortality, compared with usual care or placebo, in patients hospitalized with COVID-19.

However, no major safety issues were identified with the use of SGLT2 inhibitors in these acutely ill patients, the researchers report.

“While these findings do not support the use of SGLT2-inhibitors as standard of care for patients hospitalized with COVID-19, I think the most important take home message here is that the use of these medications appears to be safe even in really acutely ill hospitalized patients,” lead investigator of the meta-analysis, Mikhail Kosiborod, MD, Saint Luke’s Mid America Heart Institute, Kansas City, Mo., concluded.

He said this was important because the list of indications for SGLT2 inhibitors is rapidly growing.

“These medications are being used in more and more patients. And we know that when we discontinue medications in the hospital they frequently don’t get restarted, which can lead to real risks if SGLT2 inhibitors are stopped in patients with heart failure, chronic kidney disease, or diabetes. So, the bottom line is that there is no compelling reason to stop these medications in the hospital,” he added.

The new meta-analysis was presented at the recent annual congress of the European Society of Cardiology, held in Amsterdam.

Discussant of the presentation at the ESC Hotline session, Muthiah Vaduganathan, MD, MPH, Brigham and Women’s Hospital, Boston, agreed with Dr. Kosiborod’s interpretation.

“Until today we have had very limited information on the safety of SGLT2-inhibitors in acute illness, as the pivotal trials which established the use of these drugs in diabetes and chronic kidney disease largely excluded patients who were hospitalized,” Dr. Vaduganathan said.

“While the overall results of this meta-analysis are neutral and SGLT2 inhibitors will not be added as drugs to be used in the primary care of patients with COVID-19, it certainly sends a strong message of safety in acutely ill patients,” he added.

Dr. Vaduganathan explained that from the beginning of the COVID-19 pandemic, there was great interest in repurposing established therapies for alternative indications for their use in the management of COVID-19.

“Conditions that strongly predispose to adverse COVID outcomes strongly overlap with established indications for SGLT2-inhibitors. So many wondered whether these drugs may be an ideal treatment candidate for the management of COVID-19. However, there have been many safety concerns about the use of SGLT2-inhibitors in this acute setting, with worries that they may induce hemodynamic changes such an excessive lowering of blood pressure, or metabolic changes such as ketoacidosis in acutely ill patients,” he noted.

The initial DARE-19 study investigating SGLT2-inhibitors in COVID-19, with 1,250 participants, found a 20% reduction in the primary outcome of organ dysfunction or death, but this did not reach statistical significance, and no safety issues were seen. This “intriguing” result led to two further larger trials – the ACTIV-4a and RECOVERY trials, Dr. Vaduganathan reported.

“Those early signals of benefit seen in DARE-19 were largely not substantiated in the ACTIV-4A and RECOVERY trials, or in this new meta-analysis, and now we have this much larger body of evidence and more stable estimates about the efficacy of these drugs in acutely ill COVID-19 patients,” he said.

“But the story that we will all take forward is one of safety. This set of trials was arguably conducted in some of the sickest patients we’ve seen who have been exposed to SGLT2-inhibitors, and they strongly affirm that these agents can be safely continued in the setting of acute illness, with very low rates of ketoacidosis and kidney injury, and there was no prolongation of hospital stay,” he commented.

In his presentation, Dr. Kosiborod explained that treatments targeting COVID-19 pathobiology such as dysregulated immune responses, endothelial damage, microvascular thrombosis, and inflammation have been shown to improve the key outcomes in this patient group.

SGLT2 inhibitors, which modulate similar pathobiology, provide cardiovascular protection and prevent the progression of kidney disease in patients at risk for these events, including those with type 2 diabetes, heart failure, and kidney disease, and may also lead to organ protection in a setting of acute illness such as COVID-19, he noted. However, the role of SGLT2 inhibitors in patients hospitalized with COVID-19 remains uncertain.

To address the need for more definitive efficacy data, the World Health Organization Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group conducted a prospective meta-analysis using data from the three randomized controlled trials, DARE-19, RECOVERY, and ACTIV-4a, evaluating SGLT2 inhibitors in patients hospitalized with COVID-19.

Overall, these trials randomized 6,096 participants: 3,025 to SGLT2 inhibitors and 3,071 to usual care or placebo. The average age of participants ranged between 62 and 73 years across the trials, 39% were women, and 25% had type 2 diabetes.

By 28 days after randomization, all-cause mortality, the primary endpoint, had occurred in 11.6% of the SGLT2-inhibitor patients, compared with 12.4% of those randomized to usual care or placebo, giving an odds ratio of 0.93 (95% confidence interval, 0.79-1.08; P = .33) for SGLT2 inhibitors, with consistency across trials.

Data on in-hospital and 90-day all-cause mortality were only available for two out of three trials (DARE-19 and ACTIV-4a), but the results were similar to the primary endpoint showing nonsignificant trends toward a possible benefit in the SGLT2-inhibitor group.

The results were also similar for the secondary outcomes of progression to acute kidney injury or requirement for dialysis or death, and progression to invasive mechanical ventilation, extracorporeal membrane oxygenation, or death, both assessed at 28 days.

The primary safety outcome of ketoacidosis by 28 days was observed in seven and two patients allocated to SGLT2 inhibitors and usual care or placebo, respectively, and overall, the incidence of reported serious adverse events was balanced between treatment groups.

The RECOVERY trial was supported by grants to the University of Oxford from UK Research and Innovation, the National Institute for Health and Care Research, and Wellcome. The ACTIV-4a platform was sponsored by the National Heart, Lung, and Blood Institute. DARE-19 was an investigator-initiated collaborative trial supported by AstraZeneca. Dr. Kosiborod reported numerous conflicts of interest.

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

A new meta-analysis has shown that SGLT2 inhibitors do not lead to lower 28-day all-cause mortality, compared with usual care or placebo, in patients hospitalized with COVID-19.

However, no major safety issues were identified with the use of SGLT2 inhibitors in these acutely ill patients, the researchers report.

“While these findings do not support the use of SGLT2-inhibitors as standard of care for patients hospitalized with COVID-19, I think the most important take home message here is that the use of these medications appears to be safe even in really acutely ill hospitalized patients,” lead investigator of the meta-analysis, Mikhail Kosiborod, MD, Saint Luke’s Mid America Heart Institute, Kansas City, Mo., concluded.

He said this was important because the list of indications for SGLT2 inhibitors is rapidly growing.

“These medications are being used in more and more patients. And we know that when we discontinue medications in the hospital they frequently don’t get restarted, which can lead to real risks if SGLT2 inhibitors are stopped in patients with heart failure, chronic kidney disease, or diabetes. So, the bottom line is that there is no compelling reason to stop these medications in the hospital,” he added.

The new meta-analysis was presented at the recent annual congress of the European Society of Cardiology, held in Amsterdam.

Discussant of the presentation at the ESC Hotline session, Muthiah Vaduganathan, MD, MPH, Brigham and Women’s Hospital, Boston, agreed with Dr. Kosiborod’s interpretation.

“Until today we have had very limited information on the safety of SGLT2-inhibitors in acute illness, as the pivotal trials which established the use of these drugs in diabetes and chronic kidney disease largely excluded patients who were hospitalized,” Dr. Vaduganathan said.

“While the overall results of this meta-analysis are neutral and SGLT2 inhibitors will not be added as drugs to be used in the primary care of patients with COVID-19, it certainly sends a strong message of safety in acutely ill patients,” he added.

Dr. Vaduganathan explained that from the beginning of the COVID-19 pandemic, there was great interest in repurposing established therapies for alternative indications for their use in the management of COVID-19.

“Conditions that strongly predispose to adverse COVID outcomes strongly overlap with established indications for SGLT2-inhibitors. So many wondered whether these drugs may be an ideal treatment candidate for the management of COVID-19. However, there have been many safety concerns about the use of SGLT2-inhibitors in this acute setting, with worries that they may induce hemodynamic changes such an excessive lowering of blood pressure, or metabolic changes such as ketoacidosis in acutely ill patients,” he noted.

The initial DARE-19 study investigating SGLT2-inhibitors in COVID-19, with 1,250 participants, found a 20% reduction in the primary outcome of organ dysfunction or death, but this did not reach statistical significance, and no safety issues were seen. This “intriguing” result led to two further larger trials – the ACTIV-4a and RECOVERY trials, Dr. Vaduganathan reported.

“Those early signals of benefit seen in DARE-19 were largely not substantiated in the ACTIV-4A and RECOVERY trials, or in this new meta-analysis, and now we have this much larger body of evidence and more stable estimates about the efficacy of these drugs in acutely ill COVID-19 patients,” he said.

“But the story that we will all take forward is one of safety. This set of trials was arguably conducted in some of the sickest patients we’ve seen who have been exposed to SGLT2-inhibitors, and they strongly affirm that these agents can be safely continued in the setting of acute illness, with very low rates of ketoacidosis and kidney injury, and there was no prolongation of hospital stay,” he commented.

In his presentation, Dr. Kosiborod explained that treatments targeting COVID-19 pathobiology such as dysregulated immune responses, endothelial damage, microvascular thrombosis, and inflammation have been shown to improve the key outcomes in this patient group.

SGLT2 inhibitors, which modulate similar pathobiology, provide cardiovascular protection and prevent the progression of kidney disease in patients at risk for these events, including those with type 2 diabetes, heart failure, and kidney disease, and may also lead to organ protection in a setting of acute illness such as COVID-19, he noted. However, the role of SGLT2 inhibitors in patients hospitalized with COVID-19 remains uncertain.

To address the need for more definitive efficacy data, the World Health Organization Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group conducted a prospective meta-analysis using data from the three randomized controlled trials, DARE-19, RECOVERY, and ACTIV-4a, evaluating SGLT2 inhibitors in patients hospitalized with COVID-19.

Overall, these trials randomized 6,096 participants: 3,025 to SGLT2 inhibitors and 3,071 to usual care or placebo. The average age of participants ranged between 62 and 73 years across the trials, 39% were women, and 25% had type 2 diabetes.

By 28 days after randomization, all-cause mortality, the primary endpoint, had occurred in 11.6% of the SGLT2-inhibitor patients, compared with 12.4% of those randomized to usual care or placebo, giving an odds ratio of 0.93 (95% confidence interval, 0.79-1.08; P = .33) for SGLT2 inhibitors, with consistency across trials.

Data on in-hospital and 90-day all-cause mortality were only available for two out of three trials (DARE-19 and ACTIV-4a), but the results were similar to the primary endpoint showing nonsignificant trends toward a possible benefit in the SGLT2-inhibitor group.

The results were also similar for the secondary outcomes of progression to acute kidney injury or requirement for dialysis or death, and progression to invasive mechanical ventilation, extracorporeal membrane oxygenation, or death, both assessed at 28 days.

The primary safety outcome of ketoacidosis by 28 days was observed in seven and two patients allocated to SGLT2 inhibitors and usual care or placebo, respectively, and overall, the incidence of reported serious adverse events was balanced between treatment groups.

The RECOVERY trial was supported by grants to the University of Oxford from UK Research and Innovation, the National Institute for Health and Care Research, and Wellcome. The ACTIV-4a platform was sponsored by the National Heart, Lung, and Blood Institute. DARE-19 was an investigator-initiated collaborative trial supported by AstraZeneca. Dr. Kosiborod reported numerous conflicts of interest.

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

A new meta-analysis has shown that SGLT2 inhibitors do not lead to lower 28-day all-cause mortality, compared with usual care or placebo, in patients hospitalized with COVID-19.

However, no major safety issues were identified with the use of SGLT2 inhibitors in these acutely ill patients, the researchers report.

“While these findings do not support the use of SGLT2-inhibitors as standard of care for patients hospitalized with COVID-19, I think the most important take home message here is that the use of these medications appears to be safe even in really acutely ill hospitalized patients,” lead investigator of the meta-analysis, Mikhail Kosiborod, MD, Saint Luke’s Mid America Heart Institute, Kansas City, Mo., concluded.

He said this was important because the list of indications for SGLT2 inhibitors is rapidly growing.

“These medications are being used in more and more patients. And we know that when we discontinue medications in the hospital they frequently don’t get restarted, which can lead to real risks if SGLT2 inhibitors are stopped in patients with heart failure, chronic kidney disease, or diabetes. So, the bottom line is that there is no compelling reason to stop these medications in the hospital,” he added.

The new meta-analysis was presented at the recent annual congress of the European Society of Cardiology, held in Amsterdam.

Discussant of the presentation at the ESC Hotline session, Muthiah Vaduganathan, MD, MPH, Brigham and Women’s Hospital, Boston, agreed with Dr. Kosiborod’s interpretation.

“Until today we have had very limited information on the safety of SGLT2-inhibitors in acute illness, as the pivotal trials which established the use of these drugs in diabetes and chronic kidney disease largely excluded patients who were hospitalized,” Dr. Vaduganathan said.

“While the overall results of this meta-analysis are neutral and SGLT2 inhibitors will not be added as drugs to be used in the primary care of patients with COVID-19, it certainly sends a strong message of safety in acutely ill patients,” he added.

Dr. Vaduganathan explained that from the beginning of the COVID-19 pandemic, there was great interest in repurposing established therapies for alternative indications for their use in the management of COVID-19.

“Conditions that strongly predispose to adverse COVID outcomes strongly overlap with established indications for SGLT2-inhibitors. So many wondered whether these drugs may be an ideal treatment candidate for the management of COVID-19. However, there have been many safety concerns about the use of SGLT2-inhibitors in this acute setting, with worries that they may induce hemodynamic changes such an excessive lowering of blood pressure, or metabolic changes such as ketoacidosis in acutely ill patients,” he noted.

The initial DARE-19 study investigating SGLT2-inhibitors in COVID-19, with 1,250 participants, found a 20% reduction in the primary outcome of organ dysfunction or death, but this did not reach statistical significance, and no safety issues were seen. This “intriguing” result led to two further larger trials – the ACTIV-4a and RECOVERY trials, Dr. Vaduganathan reported.

“Those early signals of benefit seen in DARE-19 were largely not substantiated in the ACTIV-4A and RECOVERY trials, or in this new meta-analysis, and now we have this much larger body of evidence and more stable estimates about the efficacy of these drugs in acutely ill COVID-19 patients,” he said.

“But the story that we will all take forward is one of safety. This set of trials was arguably conducted in some of the sickest patients we’ve seen who have been exposed to SGLT2-inhibitors, and they strongly affirm that these agents can be safely continued in the setting of acute illness, with very low rates of ketoacidosis and kidney injury, and there was no prolongation of hospital stay,” he commented.

In his presentation, Dr. Kosiborod explained that treatments targeting COVID-19 pathobiology such as dysregulated immune responses, endothelial damage, microvascular thrombosis, and inflammation have been shown to improve the key outcomes in this patient group.

SGLT2 inhibitors, which modulate similar pathobiology, provide cardiovascular protection and prevent the progression of kidney disease in patients at risk for these events, including those with type 2 diabetes, heart failure, and kidney disease, and may also lead to organ protection in a setting of acute illness such as COVID-19, he noted. However, the role of SGLT2 inhibitors in patients hospitalized with COVID-19 remains uncertain.

To address the need for more definitive efficacy data, the World Health Organization Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group conducted a prospective meta-analysis using data from the three randomized controlled trials, DARE-19, RECOVERY, and ACTIV-4a, evaluating SGLT2 inhibitors in patients hospitalized with COVID-19.

Overall, these trials randomized 6,096 participants: 3,025 to SGLT2 inhibitors and 3,071 to usual care or placebo. The average age of participants ranged between 62 and 73 years across the trials, 39% were women, and 25% had type 2 diabetes.

By 28 days after randomization, all-cause mortality, the primary endpoint, had occurred in 11.6% of the SGLT2-inhibitor patients, compared with 12.4% of those randomized to usual care or placebo, giving an odds ratio of 0.93 (95% confidence interval, 0.79-1.08; P = .33) for SGLT2 inhibitors, with consistency across trials.

Data on in-hospital and 90-day all-cause mortality were only available for two out of three trials (DARE-19 and ACTIV-4a), but the results were similar to the primary endpoint showing nonsignificant trends toward a possible benefit in the SGLT2-inhibitor group.

The results were also similar for the secondary outcomes of progression to acute kidney injury or requirement for dialysis or death, and progression to invasive mechanical ventilation, extracorporeal membrane oxygenation, or death, both assessed at 28 days.

The primary safety outcome of ketoacidosis by 28 days was observed in seven and two patients allocated to SGLT2 inhibitors and usual care or placebo, respectively, and overall, the incidence of reported serious adverse events was balanced between treatment groups.

The RECOVERY trial was supported by grants to the University of Oxford from UK Research and Innovation, the National Institute for Health and Care Research, and Wellcome. The ACTIV-4a platform was sponsored by the National Heart, Lung, and Blood Institute. DARE-19 was an investigator-initiated collaborative trial supported by AstraZeneca. Dr. Kosiborod reported numerous conflicts of interest.

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

What happens to grief when those around you don’t understand it? Where does it go? How do you process it?

Disenfranchised grief, when someone or society more generally doesn’t see a loss as worthy of mourning, can deprive people of experiencing or processing their sadness. This grief, which may be triggered by the death of an ex-spouse, a pet, a failed adoption, can be painful and long-lasting.

Here, we reflect as physicians on our own experiences and memories of this phenomenon.
 

Suzanne Cole, MD: ‘I didn’t feel the right to grieve’

During the COVID-19 pandemic, my little sister unexpectedly died. Though she was not one of the nearly 7 million people who died of the virus, in 2021 she became another type of statistic: one of the 109,699 people in the United State who died from a drug overdose. Hers was from fentanyl laced with methamphetamines.

Her death unraveled me. I felt deep guilt that I could not pull her from the sweeping current that had wrenched her from mainstream society into the underbelly of sex work and toward the solace of mind-altering drugs.

But I did not feel the right to grieve for her as I have grieved for other loved ones who were not blamed for their exit from this world. My sister was living a sordid life on the fringes of society. My grief felt invalid, undeserved. Yet, in the eyes of other “upstanding citizens,” her life was not as worth grieving – or so I thought. I tucked my sorrow into a small corner of my soul so no one would see, and I carried on.

To this day, the shame I feel robbed me of the ability to freely talk about her or share the searing pain I feel. Tears still prick my eyes when I think of her, but I have become adept at swallowing them, shaking off the waves of grief as though nothing happened. Even now, I cannot shake the pervasive feeling that my silent tears don’t deserve to be wept.
 

Don S. Dizon, MD: Working through tragedy

As a medical student, I worked with an outpatient physician as part of a third-year rotation. When we met, the first thing that struck me was how disheveled he looked. His clothes were wrinkled, and his pants were baggy. He took cigarette breaks, which I found disturbing.

But I quickly came to admire him. Despite my first impression, he was the type of doctor I aspired to be. He didn’t need to look at a patient’s chart to recall who they were. He just knew them. He greeted patients warmly, asked about their family. He even remembered the special occasions his patients had mentioned since their past visit. He epitomized empathy and connectedness.

Spending one day in clinic brought to light the challenges of forming such bonds with patients. A man came into the cancer clinic reporting chest pain and was triaged to an exam room. Soon after, the patient was found unresponsive on the floor. Nurses were yelling for help, and the doctor ran in and started CPR while minutes ticked by waiting for an ambulance that could take him to the ED.

By the time help arrived, the patient was blue.

He had died in the clinic in the middle of the day, as the waiting room filled. After the body was taken away, the doctor went into the bathroom. About 20 minutes later, he came out, eyes bloodshot, and continued with the rest of his day, ensuring each patient was seen and cared for.

As a medical student, it hit me how hard it must be to see something so tragic like the end of a life and then continue with your day as if nothing had happened. This is an experience of grief I later came to know well after nearly 30 years treating patients with advanced cancers: compartmentalizing it and carrying on.
 

A space for grieving: The Schwartz Center Rounds

Disenfranchised grief, the grief that is hard to share and often seems wrong to feel in the first place, can be triggered in many situations. Losing a person others don’t believe deserve to be grieved, such as an abusive partner or someone who committed a crime; losing someone you cared for in a professional role; a loss experienced in a breakup or same-sex partnership, if that relationship was not accepted by one’s family; loss from infertility, miscarriage, stillbirth, or failed adoption; loss that may be taboo or stigmatized, such as deaths via suicide or abortion; and loss of a job, home, or possession that you treasure.

Many of us have had similar situations or will, and the feeling that no one understands the need to mourn can be paralyzing and alienating. In the early days, intense, crushing feelings can cause intrusive, distracting thoughts, and over time, that grief can linger and find a permanent place in our minds.

More and more, though, we are being given opportunities to reflect on these sad moments.

The Schwartz Rounds are an example of such an opportunity. In these rounds, we gather to talk about the experience of caring for people, not the science of medicine.

During one particularly powerful rounds, I spoke to my colleagues about my initial meeting with a patient who was very sick. I detailed the experience of telling her children and her at that initial consult how I thought she was dying and that I did not recommend therapy. I remember how they cried. And I remembered how powerless I felt.

As I recalled that memory during Schwartz Rounds, I could not stop from crying. The unfairness of being a physician meeting someone for the first time and having to tell them such bad news overwhelmed me.

Even more poignant, I had the chance to reconnect with this woman’s children, who were present that day, not as audience members but as participants. Their presence may have brought my emotions to the surface more strongly. In that moment, I could show them the feelings I had bottled up for the sake of professionalism. Ultimately, I felt relieved, freer somehow, as if this burden my soul was carrying had been lifted.

Although we are both grateful for forums like this, these opportunities to share and express the grief we may have hidden away are not as common as they should be.

As physicians, we may express grief by shedding tears at the bedside of a patient nearing the end of life or through the anxiety we feel when our patient suffers a severe reaction to treatment. But we tend to put it away, to go on with our day, because there are others to be seen and cared for and more work to be done. Somehow, we move forward, shedding tears in one room and celebrating victories in another.

We need to create more spaces to express and feel grief, so we don’t get lost in it. Because understanding how grief impacts us, as people and as providers, is one of the most important realizations we can make as we go about our time-honored profession as healers.

Dr. Dizon is the director of women’s cancers at Lifespan Cancer Institute, director of medical oncology at Rhode Island Hospital, and a professor of medicine at Brown University, all in Providence. He reported conflicts of interest with Regeneron, AstraZeneca, Clovis, Bristol-Myers Squibb, and Kazia.

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

What happens to grief when those around you don’t understand it? Where does it go? How do you process it?

Disenfranchised grief, when someone or society more generally doesn’t see a loss as worthy of mourning, can deprive people of experiencing or processing their sadness. This grief, which may be triggered by the death of an ex-spouse, a pet, a failed adoption, can be painful and long-lasting.

Here, we reflect as physicians on our own experiences and memories of this phenomenon.
 

Suzanne Cole, MD: ‘I didn’t feel the right to grieve’

During the COVID-19 pandemic, my little sister unexpectedly died. Though she was not one of the nearly 7 million people who died of the virus, in 2021 she became another type of statistic: one of the 109,699 people in the United State who died from a drug overdose. Hers was from fentanyl laced with methamphetamines.

Her death unraveled me. I felt deep guilt that I could not pull her from the sweeping current that had wrenched her from mainstream society into the underbelly of sex work and toward the solace of mind-altering drugs.

But I did not feel the right to grieve for her as I have grieved for other loved ones who were not blamed for their exit from this world. My sister was living a sordid life on the fringes of society. My grief felt invalid, undeserved. Yet, in the eyes of other “upstanding citizens,” her life was not as worth grieving – or so I thought. I tucked my sorrow into a small corner of my soul so no one would see, and I carried on.

To this day, the shame I feel robbed me of the ability to freely talk about her or share the searing pain I feel. Tears still prick my eyes when I think of her, but I have become adept at swallowing them, shaking off the waves of grief as though nothing happened. Even now, I cannot shake the pervasive feeling that my silent tears don’t deserve to be wept.
 

Don S. Dizon, MD: Working through tragedy

As a medical student, I worked with an outpatient physician as part of a third-year rotation. When we met, the first thing that struck me was how disheveled he looked. His clothes were wrinkled, and his pants were baggy. He took cigarette breaks, which I found disturbing.

But I quickly came to admire him. Despite my first impression, he was the type of doctor I aspired to be. He didn’t need to look at a patient’s chart to recall who they were. He just knew them. He greeted patients warmly, asked about their family. He even remembered the special occasions his patients had mentioned since their past visit. He epitomized empathy and connectedness.

Spending one day in clinic brought to light the challenges of forming such bonds with patients. A man came into the cancer clinic reporting chest pain and was triaged to an exam room. Soon after, the patient was found unresponsive on the floor. Nurses were yelling for help, and the doctor ran in and started CPR while minutes ticked by waiting for an ambulance that could take him to the ED.

By the time help arrived, the patient was blue.

He had died in the clinic in the middle of the day, as the waiting room filled. After the body was taken away, the doctor went into the bathroom. About 20 minutes later, he came out, eyes bloodshot, and continued with the rest of his day, ensuring each patient was seen and cared for.

As a medical student, it hit me how hard it must be to see something so tragic like the end of a life and then continue with your day as if nothing had happened. This is an experience of grief I later came to know well after nearly 30 years treating patients with advanced cancers: compartmentalizing it and carrying on.
 

A space for grieving: The Schwartz Center Rounds

Disenfranchised grief, the grief that is hard to share and often seems wrong to feel in the first place, can be triggered in many situations. Losing a person others don’t believe deserve to be grieved, such as an abusive partner or someone who committed a crime; losing someone you cared for in a professional role; a loss experienced in a breakup or same-sex partnership, if that relationship was not accepted by one’s family; loss from infertility, miscarriage, stillbirth, or failed adoption; loss that may be taboo or stigmatized, such as deaths via suicide or abortion; and loss of a job, home, or possession that you treasure.

Many of us have had similar situations or will, and the feeling that no one understands the need to mourn can be paralyzing and alienating. In the early days, intense, crushing feelings can cause intrusive, distracting thoughts, and over time, that grief can linger and find a permanent place in our minds.

More and more, though, we are being given opportunities to reflect on these sad moments.

The Schwartz Rounds are an example of such an opportunity. In these rounds, we gather to talk about the experience of caring for people, not the science of medicine.

During one particularly powerful rounds, I spoke to my colleagues about my initial meeting with a patient who was very sick. I detailed the experience of telling her children and her at that initial consult how I thought she was dying and that I did not recommend therapy. I remember how they cried. And I remembered how powerless I felt.

As I recalled that memory during Schwartz Rounds, I could not stop from crying. The unfairness of being a physician meeting someone for the first time and having to tell them such bad news overwhelmed me.

Even more poignant, I had the chance to reconnect with this woman’s children, who were present that day, not as audience members but as participants. Their presence may have brought my emotions to the surface more strongly. In that moment, I could show them the feelings I had bottled up for the sake of professionalism. Ultimately, I felt relieved, freer somehow, as if this burden my soul was carrying had been lifted.

Although we are both grateful for forums like this, these opportunities to share and express the grief we may have hidden away are not as common as they should be.

As physicians, we may express grief by shedding tears at the bedside of a patient nearing the end of life or through the anxiety we feel when our patient suffers a severe reaction to treatment. But we tend to put it away, to go on with our day, because there are others to be seen and cared for and more work to be done. Somehow, we move forward, shedding tears in one room and celebrating victories in another.

We need to create more spaces to express and feel grief, so we don’t get lost in it. Because understanding how grief impacts us, as people and as providers, is one of the most important realizations we can make as we go about our time-honored profession as healers.

Dr. Dizon is the director of women’s cancers at Lifespan Cancer Institute, director of medical oncology at Rhode Island Hospital, and a professor of medicine at Brown University, all in Providence. He reported conflicts of interest with Regeneron, AstraZeneca, Clovis, Bristol-Myers Squibb, and Kazia.

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

What happens to grief when those around you don’t understand it? Where does it go? How do you process it?

Disenfranchised grief, when someone or society more generally doesn’t see a loss as worthy of mourning, can deprive people of experiencing or processing their sadness. This grief, which may be triggered by the death of an ex-spouse, a pet, a failed adoption, can be painful and long-lasting.

Here, we reflect as physicians on our own experiences and memories of this phenomenon.
 

Suzanne Cole, MD: ‘I didn’t feel the right to grieve’

During the COVID-19 pandemic, my little sister unexpectedly died. Though she was not one of the nearly 7 million people who died of the virus, in 2021 she became another type of statistic: one of the 109,699 people in the United State who died from a drug overdose. Hers was from fentanyl laced with methamphetamines.

Her death unraveled me. I felt deep guilt that I could not pull her from the sweeping current that had wrenched her from mainstream society into the underbelly of sex work and toward the solace of mind-altering drugs.

But I did not feel the right to grieve for her as I have grieved for other loved ones who were not blamed for their exit from this world. My sister was living a sordid life on the fringes of society. My grief felt invalid, undeserved. Yet, in the eyes of other “upstanding citizens,” her life was not as worth grieving – or so I thought. I tucked my sorrow into a small corner of my soul so no one would see, and I carried on.

To this day, the shame I feel robbed me of the ability to freely talk about her or share the searing pain I feel. Tears still prick my eyes when I think of her, but I have become adept at swallowing them, shaking off the waves of grief as though nothing happened. Even now, I cannot shake the pervasive feeling that my silent tears don’t deserve to be wept.
 

Don S. Dizon, MD: Working through tragedy

As a medical student, I worked with an outpatient physician as part of a third-year rotation. When we met, the first thing that struck me was how disheveled he looked. His clothes were wrinkled, and his pants were baggy. He took cigarette breaks, which I found disturbing.

But I quickly came to admire him. Despite my first impression, he was the type of doctor I aspired to be. He didn’t need to look at a patient’s chart to recall who they were. He just knew them. He greeted patients warmly, asked about their family. He even remembered the special occasions his patients had mentioned since their past visit. He epitomized empathy and connectedness.

Spending one day in clinic brought to light the challenges of forming such bonds with patients. A man came into the cancer clinic reporting chest pain and was triaged to an exam room. Soon after, the patient was found unresponsive on the floor. Nurses were yelling for help, and the doctor ran in and started CPR while minutes ticked by waiting for an ambulance that could take him to the ED.

By the time help arrived, the patient was blue.

He had died in the clinic in the middle of the day, as the waiting room filled. After the body was taken away, the doctor went into the bathroom. About 20 minutes later, he came out, eyes bloodshot, and continued with the rest of his day, ensuring each patient was seen and cared for.

As a medical student, it hit me how hard it must be to see something so tragic like the end of a life and then continue with your day as if nothing had happened. This is an experience of grief I later came to know well after nearly 30 years treating patients with advanced cancers: compartmentalizing it and carrying on.
 

A space for grieving: The Schwartz Center Rounds

Disenfranchised grief, the grief that is hard to share and often seems wrong to feel in the first place, can be triggered in many situations. Losing a person others don’t believe deserve to be grieved, such as an abusive partner or someone who committed a crime; losing someone you cared for in a professional role; a loss experienced in a breakup or same-sex partnership, if that relationship was not accepted by one’s family; loss from infertility, miscarriage, stillbirth, or failed adoption; loss that may be taboo or stigmatized, such as deaths via suicide or abortion; and loss of a job, home, or possession that you treasure.

Many of us have had similar situations or will, and the feeling that no one understands the need to mourn can be paralyzing and alienating. In the early days, intense, crushing feelings can cause intrusive, distracting thoughts, and over time, that grief can linger and find a permanent place in our minds.

More and more, though, we are being given opportunities to reflect on these sad moments.

The Schwartz Rounds are an example of such an opportunity. In these rounds, we gather to talk about the experience of caring for people, not the science of medicine.

During one particularly powerful rounds, I spoke to my colleagues about my initial meeting with a patient who was very sick. I detailed the experience of telling her children and her at that initial consult how I thought she was dying and that I did not recommend therapy. I remember how they cried. And I remembered how powerless I felt.

As I recalled that memory during Schwartz Rounds, I could not stop from crying. The unfairness of being a physician meeting someone for the first time and having to tell them such bad news overwhelmed me.

Even more poignant, I had the chance to reconnect with this woman’s children, who were present that day, not as audience members but as participants. Their presence may have brought my emotions to the surface more strongly. In that moment, I could show them the feelings I had bottled up for the sake of professionalism. Ultimately, I felt relieved, freer somehow, as if this burden my soul was carrying had been lifted.

Although we are both grateful for forums like this, these opportunities to share and express the grief we may have hidden away are not as common as they should be.

As physicians, we may express grief by shedding tears at the bedside of a patient nearing the end of life or through the anxiety we feel when our patient suffers a severe reaction to treatment. But we tend to put it away, to go on with our day, because there are others to be seen and cared for and more work to be done. Somehow, we move forward, shedding tears in one room and celebrating victories in another.

We need to create more spaces to express and feel grief, so we don’t get lost in it. Because understanding how grief impacts us, as people and as providers, is one of the most important realizations we can make as we go about our time-honored profession as healers.

Dr. Dizon is the director of women’s cancers at Lifespan Cancer Institute, director of medical oncology at Rhode Island Hospital, and a professor of medicine at Brown University, all in Providence. He reported conflicts of interest with Regeneron, AstraZeneca, Clovis, Bristol-Myers Squibb, and Kazia.

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

COVID vaccines will have a new formulation in 2023, according to a decision announced by the U.S. Food and Drug Administration, that will focus efforts on circulating variants. The move pushes last year’s bivalent vaccines out of circulation because they will no longer be authorized for use in the United States.

The updated mRNA vaccines for 2023-2024 are being revised to include a single component that corresponds to the Omicron variant XBB.1.5. Like the bivalents offered before, the new monovalents are being manufactured by Moderna and Pfizer.

The new vaccines are authorized for use in individuals age 6 months and older.  And the new options are being developed using a similar process as previous formulations, according to the FDA.
 

Targeting circulating variants

In recent studies, regulators point out the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5, BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with previous versions of the vaccines against corresponding prior variants.

“This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants,” according to the report.

Hundreds of millions of people in the United States have already received previously approved mRNA COVID vaccines, according to regulators who say the benefit-to-risk profile is well understood as they move forward with new formulations.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
 

Timing the effort

On Sept. 12 the U.S. Centers for Disease Control and Prevention recommended that everyone 6 months and older get an updated COVID-19 vaccine. Updated vaccines from Pfizer-BioNTech and Moderna will be available later this week, according to the agency.

This article was updated 9/14/23.

A version of this article appeared on Medscape.com.

COVID vaccines will have a new formulation in 2023, according to a decision announced by the U.S. Food and Drug Administration, that will focus efforts on circulating variants. The move pushes last year’s bivalent vaccines out of circulation because they will no longer be authorized for use in the United States.

The updated mRNA vaccines for 2023-2024 are being revised to include a single component that corresponds to the Omicron variant XBB.1.5. Like the bivalents offered before, the new monovalents are being manufactured by Moderna and Pfizer.

The new vaccines are authorized for use in individuals age 6 months and older.  And the new options are being developed using a similar process as previous formulations, according to the FDA.
 

Targeting circulating variants

In recent studies, regulators point out the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5, BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with previous versions of the vaccines against corresponding prior variants.

“This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants,” according to the report.

Hundreds of millions of people in the United States have already received previously approved mRNA COVID vaccines, according to regulators who say the benefit-to-risk profile is well understood as they move forward with new formulations.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
 

Timing the effort

On Sept. 12 the U.S. Centers for Disease Control and Prevention recommended that everyone 6 months and older get an updated COVID-19 vaccine. Updated vaccines from Pfizer-BioNTech and Moderna will be available later this week, according to the agency.

This article was updated 9/14/23.

A version of this article appeared on Medscape.com.

COVID vaccines will have a new formulation in 2023, according to a decision announced by the U.S. Food and Drug Administration, that will focus efforts on circulating variants. The move pushes last year’s bivalent vaccines out of circulation because they will no longer be authorized for use in the United States.

The updated mRNA vaccines for 2023-2024 are being revised to include a single component that corresponds to the Omicron variant XBB.1.5. Like the bivalents offered before, the new monovalents are being manufactured by Moderna and Pfizer.

The new vaccines are authorized for use in individuals age 6 months and older.  And the new options are being developed using a similar process as previous formulations, according to the FDA.
 

Targeting circulating variants

In recent studies, regulators point out the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5, BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with previous versions of the vaccines against corresponding prior variants.

“This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants,” according to the report.

Hundreds of millions of people in the United States have already received previously approved mRNA COVID vaccines, according to regulators who say the benefit-to-risk profile is well understood as they move forward with new formulations.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
 

Timing the effort

On Sept. 12 the U.S. Centers for Disease Control and Prevention recommended that everyone 6 months and older get an updated COVID-19 vaccine. Updated vaccines from Pfizer-BioNTech and Moderna will be available later this week, according to the agency.

This article was updated 9/14/23.

A version of this article appeared on Medscape.com.

The Centers for Disease Control and Prevention and the World Health Organization have dubbed the BA 2.86 variant of COVID-19 as a variant to watch. 

So far, only 26 cases of “Pirola,” as the new variant is being called, have been identified: 10 in Denmark, four each in Sweden and the United States, three in South Africa, two in Portugal, and one each the United Kingdom, Israel, and Canada. BA 2.86 is a subvariant of Omicron, but according to reports from the CDC, the strain has many more mutations than the ones that came before it. 

With so many facts still unknown about this new variant, this news organization asked experts what people need to be aware of as it continues to spread.
 

What is unique about the BA 2.86 variant? 

“It is unique in that it has more than three mutations on the spike protein,” said Purvi S. Parikh, MD, an infectious disease expert at New York University’s Langone Health. The virus uses the spike proteins to enter our cells. 

This “may mean it will be more transmissible, cause more severe disease, and/or our vaccines and treatments may not work as well, as compared to other variants,” she said.
 

What do we need to watch with BA 2.86 going forward? 

“We don’t know if this variant will be associated with a change in the disease severity. We currently see increased numbers of cases in general, even though we don’t yet see the BA.2.86 in our system,” said Heba Mostafa, PhD, director of the molecular virology laboratory at Johns Hopkins Hospital in Baltimore. 

“It is important to monitor BA.2.86 (and other variants) and understand how its evolution impacts the number of cases and disease outcomes,” she said. “We should all be aware of the current increase in cases, though, and try to get tested and be treated as soon as possible, as antivirals should be effective against the circulating variants.” 
 

What should doctors know?

Dr. Parikh said doctors should generally expect more COVID cases in their clinics and make sure to screen patients even if their symptoms are mild.

“We have tools that can be used – antivirals like Paxlovid are still efficacious with current dominant strains such as EG.5,” she said. “And encourage your patients to get their boosters, mask, wash hands, and social distance.”
 

How well can our vaccines fight BA 2.86?

“Vaccine coverage for the BA.2.86 is an area of uncertainty right now,” said Dr. Mostafa. 

In its report, the CDC said scientists are still figuring out how well the updated COVID vaccine works. It’s expected to be available in the fall, and for now, they believe the new shot will still make infections less severe, new variants and all. 

Prior vaccinations and infections have created antibodies in many people, and that will likely provide some protection, Dr. Mostafa said. “When we experienced the Omicron wave in December 2021, even though the variant was distant from what circulated before its emergence and was associated with a very large increase in the number of cases, vaccinations were still protective against severe disease.” 
 

What is the most important thing to keep track of when it comes to this variant?

According to Dr. Parikh, “it’s most important to monitor how transmissible [BA 2.86] is, how severe it is, and if our current treatments and vaccines work.” 

Dr. Mostafa said how well the new variants escape existing antibody protection should also be studied and watched closely. 
 

What does this stage of the virus mutation tell us about where we are in the pandemic?

The history of the coronavirus over the past few years shows that variants with many changes evolve and can spread very quickly, Dr. Mostafa said. “Now that the virus is endemic, it is essential to monitor, update vaccinations if necessary, diagnose, treat, and implement infection control measures when necessary.”

With the limited data we have so far, experts seem to agree that while the variant’s makeup raises some red flags, it is too soon to jump to any conclusions about how easy it is to catch it and the ways it may change how the virus impacts those who contract it.
 

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

The Centers for Disease Control and Prevention and the World Health Organization have dubbed the BA 2.86 variant of COVID-19 as a variant to watch. 

So far, only 26 cases of “Pirola,” as the new variant is being called, have been identified: 10 in Denmark, four each in Sweden and the United States, three in South Africa, two in Portugal, and one each the United Kingdom, Israel, and Canada. BA 2.86 is a subvariant of Omicron, but according to reports from the CDC, the strain has many more mutations than the ones that came before it. 

With so many facts still unknown about this new variant, this news organization asked experts what people need to be aware of as it continues to spread.
 

What is unique about the BA 2.86 variant? 

“It is unique in that it has more than three mutations on the spike protein,” said Purvi S. Parikh, MD, an infectious disease expert at New York University’s Langone Health. The virus uses the spike proteins to enter our cells. 

This “may mean it will be more transmissible, cause more severe disease, and/or our vaccines and treatments may not work as well, as compared to other variants,” she said.
 

What do we need to watch with BA 2.86 going forward? 

“We don’t know if this variant will be associated with a change in the disease severity. We currently see increased numbers of cases in general, even though we don’t yet see the BA.2.86 in our system,” said Heba Mostafa, PhD, director of the molecular virology laboratory at Johns Hopkins Hospital in Baltimore. 

“It is important to monitor BA.2.86 (and other variants) and understand how its evolution impacts the number of cases and disease outcomes,” she said. “We should all be aware of the current increase in cases, though, and try to get tested and be treated as soon as possible, as antivirals should be effective against the circulating variants.” 
 

What should doctors know?

Dr. Parikh said doctors should generally expect more COVID cases in their clinics and make sure to screen patients even if their symptoms are mild.

“We have tools that can be used – antivirals like Paxlovid are still efficacious with current dominant strains such as EG.5,” she said. “And encourage your patients to get their boosters, mask, wash hands, and social distance.”
 

How well can our vaccines fight BA 2.86?

“Vaccine coverage for the BA.2.86 is an area of uncertainty right now,” said Dr. Mostafa. 

In its report, the CDC said scientists are still figuring out how well the updated COVID vaccine works. It’s expected to be available in the fall, and for now, they believe the new shot will still make infections less severe, new variants and all. 

Prior vaccinations and infections have created antibodies in many people, and that will likely provide some protection, Dr. Mostafa said. “When we experienced the Omicron wave in December 2021, even though the variant was distant from what circulated before its emergence and was associated with a very large increase in the number of cases, vaccinations were still protective against severe disease.” 
 

What is the most important thing to keep track of when it comes to this variant?

According to Dr. Parikh, “it’s most important to monitor how transmissible [BA 2.86] is, how severe it is, and if our current treatments and vaccines work.” 

Dr. Mostafa said how well the new variants escape existing antibody protection should also be studied and watched closely. 
 

What does this stage of the virus mutation tell us about where we are in the pandemic?

The history of the coronavirus over the past few years shows that variants with many changes evolve and can spread very quickly, Dr. Mostafa said. “Now that the virus is endemic, it is essential to monitor, update vaccinations if necessary, diagnose, treat, and implement infection control measures when necessary.”

With the limited data we have so far, experts seem to agree that while the variant’s makeup raises some red flags, it is too soon to jump to any conclusions about how easy it is to catch it and the ways it may change how the virus impacts those who contract it.
 

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

The Centers for Disease Control and Prevention and the World Health Organization have dubbed the BA 2.86 variant of COVID-19 as a variant to watch. 

So far, only 26 cases of “Pirola,” as the new variant is being called, have been identified: 10 in Denmark, four each in Sweden and the United States, three in South Africa, two in Portugal, and one each the United Kingdom, Israel, and Canada. BA 2.86 is a subvariant of Omicron, but according to reports from the CDC, the strain has many more mutations than the ones that came before it. 

With so many facts still unknown about this new variant, this news organization asked experts what people need to be aware of as it continues to spread.
 

What is unique about the BA 2.86 variant? 

“It is unique in that it has more than three mutations on the spike protein,” said Purvi S. Parikh, MD, an infectious disease expert at New York University’s Langone Health. The virus uses the spike proteins to enter our cells. 

This “may mean it will be more transmissible, cause more severe disease, and/or our vaccines and treatments may not work as well, as compared to other variants,” she said.
 

What do we need to watch with BA 2.86 going forward? 

“We don’t know if this variant will be associated with a change in the disease severity. We currently see increased numbers of cases in general, even though we don’t yet see the BA.2.86 in our system,” said Heba Mostafa, PhD, director of the molecular virology laboratory at Johns Hopkins Hospital in Baltimore. 

“It is important to monitor BA.2.86 (and other variants) and understand how its evolution impacts the number of cases and disease outcomes,” she said. “We should all be aware of the current increase in cases, though, and try to get tested and be treated as soon as possible, as antivirals should be effective against the circulating variants.” 
 

What should doctors know?

Dr. Parikh said doctors should generally expect more COVID cases in their clinics and make sure to screen patients even if their symptoms are mild.

“We have tools that can be used – antivirals like Paxlovid are still efficacious with current dominant strains such as EG.5,” she said. “And encourage your patients to get their boosters, mask, wash hands, and social distance.”
 

How well can our vaccines fight BA 2.86?

“Vaccine coverage for the BA.2.86 is an area of uncertainty right now,” said Dr. Mostafa. 

In its report, the CDC said scientists are still figuring out how well the updated COVID vaccine works. It’s expected to be available in the fall, and for now, they believe the new shot will still make infections less severe, new variants and all. 

Prior vaccinations and infections have created antibodies in many people, and that will likely provide some protection, Dr. Mostafa said. “When we experienced the Omicron wave in December 2021, even though the variant was distant from what circulated before its emergence and was associated with a very large increase in the number of cases, vaccinations were still protective against severe disease.” 
 

What is the most important thing to keep track of when it comes to this variant?

According to Dr. Parikh, “it’s most important to monitor how transmissible [BA 2.86] is, how severe it is, and if our current treatments and vaccines work.” 

Dr. Mostafa said how well the new variants escape existing antibody protection should also be studied and watched closely. 
 

What does this stage of the virus mutation tell us about where we are in the pandemic?

The history of the coronavirus over the past few years shows that variants with many changes evolve and can spread very quickly, Dr. Mostafa said. “Now that the virus is endemic, it is essential to monitor, update vaccinations if necessary, diagnose, treat, and implement infection control measures when necessary.”

With the limited data we have so far, experts seem to agree that while the variant’s makeup raises some red flags, it is too soon to jump to any conclusions about how easy it is to catch it and the ways it may change how the virus impacts those who contract it.
 

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

Advanced practice providers (APPs) such as nurse practitioners (NPs) and physician assistants (PAs) have long been at odds with doctor groups over scope of practice issues. But in a rare alliance, more than 500 physicians, NPs, and PAs at Allina Health primary care and urgent care clinics in Minneapolis recently filed a petition with the National Labor Relations Board to hold a union election in late September. If successful, the Allina group will join the Doctors Council SEIU, Local 10MD.

The Allina health care providers share concerns about their working conditions, such as understaffing and inadequate resources, limited decision-making authority, and health systems valuing productivity and profit over patient care.

Although doctors and APPs have said that they generally work well together, the relationship has been strained in recent years as APPs argue for greater scope of practice. Meanwhile, physician groups, such as the American Medical Association, believe that APPs need more oversight.

An Allina union organizer, Britta V. Kasmarik, CNP, acknowledges the tension between physicians and APPs. But she said in an interview that the union effort helped bond this group of health care providers. “We share common goals of providing high-quality care for patients in a safe way, and we see the same things day in and day out with our patients.”

Matt Hoffman, MD, a primary care physician at Allina, told this news organization that APPs in his specialty perform the same job as doctors “and the working conditions are really identical. In our view, that means we should be unionizing together.”

The decision to hold a union vote follows similar action by nearly 150 Allina Mercy Hospital physicians in March. Allina Health appealed the vote.

In response to a New York Times investigation, the Minnesota Attorney General’s office began reviewing reports of aggressive billing practices and denied care at Allina Health.

The Allina Health system, which reports $4 billion in annual revenue, cut off nonemergency services to patients, including children, if their medical debt exceeded $4,500, according to the New York Times article. For Allina’s physicians and APPs, that meant leaving patients’ illnesses untreated.

Less than a week after the attorney general announced its investigation, the health system ended this practice.

In a prepared statement to this news organization, Allina Health said that its providers are “critical members of our teams. … We deeply value and share their commitment to providing high-quality care to our patients.”

The health system said it planned to make operational improvements, implement new communication tools, and provide additional well-being resources and enhanced employee benefits “to improve the provider experience.” In addition, it hoped to continue to “foster a culture of collaboration with all our employees.”

Having a union will allow health care providers to advocate for their patients and give health care providers more decision-making power instead of corporate leaders maintaining full authority, Ms. Kasmarik told this news organization.

Union organizers are also concerned with changes to the daily practice of medicine. “We don’t want to be spending our time doing paperwork and calling insurance companies and filling out forms,” said Dr. Hoffman. “We want to be in the exam room with a patient.”

The Allina providers organized after multiple requests to corporate managers failed to address their concerns. Their demands include increased staffing and help with nonclinical work so that clinicians can spend more time with their patients.

“What I’m really excited about is that we will be able to work with the other unionized groups to make change ... by being involved in health care policy at a state or national level,” Dr. Hoffman said. For example, that involvement might include challenging insurance company decisions.

Doctors Council bills itself as the largest union for attending physicians in the country, with 3,500 members, according to Joe Crane, national organizing director.

Despite an increase in union efforts since the pandemic, health care workers – particularly doctors – have been slow to join unions. Mr. Crane estimated that only about 3% of U.S. physicians are currently union members. He cited union campaigns in Massachusetts, New York, and Washington, DC. For comparison, a minority of advanced practice registered nurses (APRNs) (9%) report union membership, according to Medscape’s APRN compensation report last year.

Dr. Hoffman is confident the Allina health care providers will have enough votes to win the election to join the union. “We should have done this years ago.”

A version of this article appeared on Medscape.com.

Advanced practice providers (APPs) such as nurse practitioners (NPs) and physician assistants (PAs) have long been at odds with doctor groups over scope of practice issues. But in a rare alliance, more than 500 physicians, NPs, and PAs at Allina Health primary care and urgent care clinics in Minneapolis recently filed a petition with the National Labor Relations Board to hold a union election in late September. If successful, the Allina group will join the Doctors Council SEIU, Local 10MD.

The Allina health care providers share concerns about their working conditions, such as understaffing and inadequate resources, limited decision-making authority, and health systems valuing productivity and profit over patient care.

Although doctors and APPs have said that they generally work well together, the relationship has been strained in recent years as APPs argue for greater scope of practice. Meanwhile, physician groups, such as the American Medical Association, believe that APPs need more oversight.

An Allina union organizer, Britta V. Kasmarik, CNP, acknowledges the tension between physicians and APPs. But she said in an interview that the union effort helped bond this group of health care providers. “We share common goals of providing high-quality care for patients in a safe way, and we see the same things day in and day out with our patients.”

Matt Hoffman, MD, a primary care physician at Allina, told this news organization that APPs in his specialty perform the same job as doctors “and the working conditions are really identical. In our view, that means we should be unionizing together.”

The decision to hold a union vote follows similar action by nearly 150 Allina Mercy Hospital physicians in March. Allina Health appealed the vote.

In response to a New York Times investigation, the Minnesota Attorney General’s office began reviewing reports of aggressive billing practices and denied care at Allina Health.

The Allina Health system, which reports $4 billion in annual revenue, cut off nonemergency services to patients, including children, if their medical debt exceeded $4,500, according to the New York Times article. For Allina’s physicians and APPs, that meant leaving patients’ illnesses untreated.

Less than a week after the attorney general announced its investigation, the health system ended this practice.

In a prepared statement to this news organization, Allina Health said that its providers are “critical members of our teams. … We deeply value and share their commitment to providing high-quality care to our patients.”

The health system said it planned to make operational improvements, implement new communication tools, and provide additional well-being resources and enhanced employee benefits “to improve the provider experience.” In addition, it hoped to continue to “foster a culture of collaboration with all our employees.”

Having a union will allow health care providers to advocate for their patients and give health care providers more decision-making power instead of corporate leaders maintaining full authority, Ms. Kasmarik told this news organization.

Union organizers are also concerned with changes to the daily practice of medicine. “We don’t want to be spending our time doing paperwork and calling insurance companies and filling out forms,” said Dr. Hoffman. “We want to be in the exam room with a patient.”

The Allina providers organized after multiple requests to corporate managers failed to address their concerns. Their demands include increased staffing and help with nonclinical work so that clinicians can spend more time with their patients.

“What I’m really excited about is that we will be able to work with the other unionized groups to make change ... by being involved in health care policy at a state or national level,” Dr. Hoffman said. For example, that involvement might include challenging insurance company decisions.

Doctors Council bills itself as the largest union for attending physicians in the country, with 3,500 members, according to Joe Crane, national organizing director.

Despite an increase in union efforts since the pandemic, health care workers – particularly doctors – have been slow to join unions. Mr. Crane estimated that only about 3% of U.S. physicians are currently union members. He cited union campaigns in Massachusetts, New York, and Washington, DC. For comparison, a minority of advanced practice registered nurses (APRNs) (9%) report union membership, according to Medscape’s APRN compensation report last year.

Dr. Hoffman is confident the Allina health care providers will have enough votes to win the election to join the union. “We should have done this years ago.”

A version of this article appeared on Medscape.com.

Advanced practice providers (APPs) such as nurse practitioners (NPs) and physician assistants (PAs) have long been at odds with doctor groups over scope of practice issues. But in a rare alliance, more than 500 physicians, NPs, and PAs at Allina Health primary care and urgent care clinics in Minneapolis recently filed a petition with the National Labor Relations Board to hold a union election in late September. If successful, the Allina group will join the Doctors Council SEIU, Local 10MD.

The Allina health care providers share concerns about their working conditions, such as understaffing and inadequate resources, limited decision-making authority, and health systems valuing productivity and profit over patient care.

Although doctors and APPs have said that they generally work well together, the relationship has been strained in recent years as APPs argue for greater scope of practice. Meanwhile, physician groups, such as the American Medical Association, believe that APPs need more oversight.

An Allina union organizer, Britta V. Kasmarik, CNP, acknowledges the tension between physicians and APPs. But she said in an interview that the union effort helped bond this group of health care providers. “We share common goals of providing high-quality care for patients in a safe way, and we see the same things day in and day out with our patients.”

Matt Hoffman, MD, a primary care physician at Allina, told this news organization that APPs in his specialty perform the same job as doctors “and the working conditions are really identical. In our view, that means we should be unionizing together.”

The decision to hold a union vote follows similar action by nearly 150 Allina Mercy Hospital physicians in March. Allina Health appealed the vote.

In response to a New York Times investigation, the Minnesota Attorney General’s office began reviewing reports of aggressive billing practices and denied care at Allina Health.

The Allina Health system, which reports $4 billion in annual revenue, cut off nonemergency services to patients, including children, if their medical debt exceeded $4,500, according to the New York Times article. For Allina’s physicians and APPs, that meant leaving patients’ illnesses untreated.

Less than a week after the attorney general announced its investigation, the health system ended this practice.

In a prepared statement to this news organization, Allina Health said that its providers are “critical members of our teams. … We deeply value and share their commitment to providing high-quality care to our patients.”

The health system said it planned to make operational improvements, implement new communication tools, and provide additional well-being resources and enhanced employee benefits “to improve the provider experience.” In addition, it hoped to continue to “foster a culture of collaboration with all our employees.”

Having a union will allow health care providers to advocate for their patients and give health care providers more decision-making power instead of corporate leaders maintaining full authority, Ms. Kasmarik told this news organization.

Union organizers are also concerned with changes to the daily practice of medicine. “We don’t want to be spending our time doing paperwork and calling insurance companies and filling out forms,” said Dr. Hoffman. “We want to be in the exam room with a patient.”

The Allina providers organized after multiple requests to corporate managers failed to address their concerns. Their demands include increased staffing and help with nonclinical work so that clinicians can spend more time with their patients.

“What I’m really excited about is that we will be able to work with the other unionized groups to make change ... by being involved in health care policy at a state or national level,” Dr. Hoffman said. For example, that involvement might include challenging insurance company decisions.

Doctors Council bills itself as the largest union for attending physicians in the country, with 3,500 members, according to Joe Crane, national organizing director.

Despite an increase in union efforts since the pandemic, health care workers – particularly doctors – have been slow to join unions. Mr. Crane estimated that only about 3% of U.S. physicians are currently union members. He cited union campaigns in Massachusetts, New York, and Washington, DC. For comparison, a minority of advanced practice registered nurses (APRNs) (9%) report union membership, according to Medscape’s APRN compensation report last year.

Dr. Hoffman is confident the Allina health care providers will have enough votes to win the election to join the union. “We should have done this years ago.”

A version of this article appeared on Medscape.com.

COVID-19 hospitalizations have been on the rise for weeks as summer nears its end, but how concerned should you be? SARS-CoV-2, the virus behind COVID, continues to evolve and surprise us. So COVID transmission, hospitalization, and death rates can be difficult to predict. 

This news organization turned to the experts for their take on the current circulating virus, asking them to predict if we’ll be masking up again anytime soon, and what this fall and winter might look like, especially now that testing and vaccinations are no longer free of charge.
 

Question 1: Are you expecting an end-of-summer COVID wave to be substantial?

Eric Topol, MD: “This wave won’t likely be substantial and could be more of a ‘wavelet.’ I’m not thinking that physicians are too concerned,” said Dr. Topol, founder and director of Scripps Research Translational Institute in La Jolla, Calif. 

Thomas Gut, DO: “It’s always impossible to predict the severity of COVID waves. Although the virus has generally mutated in ways that favor easier transmission and milder illness, there have been a handful of surprising mutations that were more dangerous and deadly than the preceding strain,” said Dr. Gut, associate chair of medicine at Staten Island University Hospital/Northwell Health in New York.

Robert Atmar, MD: “I’ll start with the caveat that prognosticating for SARS-CoV-2 is a bit hazardous as we remain in unknown territory for some aspects of its epidemiology and evolution,” said Dr. Atmar, a professor of infectious diseases at Baylor College of Medicine in Houston. “It depends on your definition of substantial. We, at least in Houston, are already in the midst of a substantial surge in the burden of infection, at least as monitored through wastewater surveillance. The amount of virus in the wastewater already exceeds the peak level we saw last winter. That said, the increased infection burden has not translated into large increases in hospitalizations for COVID-19. Most persons hospitalized in our hospital are admitted with infection, not for the consequences of infection.”

Stuart Campbell Ray, MD: “It looks like there is a rise in infections, but the proportional rise in hospitalizations from severe cases is lower than in the past, suggesting that folks are protected by the immunity we’ve gained over the past few years through vaccination and prior infections. Of course, we should be thinking about how that applies to each of us – how recently we had a vaccine or COVID-19, and whether we might see more severe infections as immunity wanes,” said Dr. Ray, who is a professor of medicine in the division of infectious diseases at Johns Hopkins University in Baltimore. 

Question 2: Is a return to masks or mask mandates coming this fall or winter?

Dr. Topol: “Mandating masks doesn’t work very well, but we may see wide use again if a descendant of [variant] BA.2.86 takes off.”

Dr. Gut: “It’s difficult to predict if there are any mask mandates returning at any point. Ever since the Omicron strains emerged, COVID has been relatively mild, compared to previous strains, so there probably won’t be any plan to start masking in public unless a more deadly strain appears.”

Dr. Atmar: “I do not think we will see a return to mask mandates this fall or winter for a variety of reasons. The primary one is that I don’t think the public will accept mask mandates. However, I think masking can continue to be an adjunctive measure to enhance protection from infection, along with booster vaccination.”

Dr. Ray: “Some people will choose to wear masks during a surge, particularly in situations like commuting where they don’t interfere with what they’re doing. They will wear masks particularly if they want to avoid infection due to concerns about others they care about, disruption of work or travel plans, or concerns about long-term consequences of repeated COVID-19.”

Question 3: Now that COVID testing and vaccinations are no longer free of charge, how might that affect their use?

Dr. Topol: “It was already low, and this will undoubtedly further compromise their uptake.”

Dr. Gut: “I do expect that testing will become less common now that tests are no longer free. I’m sure there will be a lower amount of detection in patients with milder or asymptomatic disease compared to what we had previously.”

Dr. Atmar: “If there are out-of-pocket costs for the SARS-CoV-2 vaccine, or if the administrative paperwork attached to getting a vaccine is increased, the uptake of SARS-CoV-2 vaccines will likely decrease. It will be important to communicate to the populations targeted for vaccination the potential benefits of such vaccination.”

Dr. Ray: “A challenge with COVID-19, all along, has been disparities in access to care, and this will be worse without public support for prevention and testing. This applies to everyone but is especially burdensome for those who are often marginalized in our health care system and society in general. I hope that we’ll find ways to ensure that people who need tests and vaccinations are able to access them, as good health is in everyone’s interest.”

Question 4: Will the new vaccines against COVID work for the currently circulating variants?

Dr. Topol: “The XBB.1.5 boosters will be out Sept. 14. They should help versus EG.5.1 and FL.1.5.1. The FL.1.5.1 variant is gaining now.”

Dr. Gut: “In the next several weeks, we expect the newer monovalent XBB-based vaccines to be offered that offer good protection against current circulating COVID variants along with the new Eris variant.”

Dr. Atmar: “The vaccines are expected to induce immune responses to the currently circulating variants, most of which are strains that evolved from the vaccine strain. The vaccine is expected to be most effective in preventing severe illness and will likely be less effective in preventing infection and mild illness.”

Dr. Ray: “Yes, the updated vaccine design has a spike antigen (XBB.1.5) nearly identical to the current dominant variant (EG.5). Even as variants change, the boosters stimulate B cells and T cells to help protect in a way that is safer than getting COVID-19 infection.”

Question 5: Is there anything we should watch out for regarding the BA.2.86 variant in particular?

Dr. Topol: “The scenario could change if there are new functional mutations added to it.”

Dr. Gut: “BA.2.86 is still fairly uncommon and does not have much data to directly make any informed guesses. However, in general, people that have been exposed to more recent mutations of the COVID virus have been shown to have more protection from newer upcoming mutations. It’s fair to guess that people that have not had recent infection from COVID, or have not had a recent booster, are at higher risk for being infected by any XBB- or BA.2-based strains.”

Dr. Atmar: BA.2.86 has been designated as a variant under monitoring. We will want to see whether it becomes more common and if there are any unexpected characteristics associated with infection by this variant.”

Dr. Ray: “It’s still rare, but it’s been seen in geographically dispersed places, so it’s got legs. The question is how effectively it will bypass some of the immunity we’ve gained. T cells are likely to remain protective, because they target so many parts of the virus that change more slowly, but antibodies from B cells to spike protein may have more trouble recognizing BA.2.86, whether those antibodies were made to a vaccine or a prior variant.”

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

COVID-19 hospitalizations have been on the rise for weeks as summer nears its end, but how concerned should you be? SARS-CoV-2, the virus behind COVID, continues to evolve and surprise us. So COVID transmission, hospitalization, and death rates can be difficult to predict. 

This news organization turned to the experts for their take on the current circulating virus, asking them to predict if we’ll be masking up again anytime soon, and what this fall and winter might look like, especially now that testing and vaccinations are no longer free of charge.
 

Question 1: Are you expecting an end-of-summer COVID wave to be substantial?

Eric Topol, MD: “This wave won’t likely be substantial and could be more of a ‘wavelet.’ I’m not thinking that physicians are too concerned,” said Dr. Topol, founder and director of Scripps Research Translational Institute in La Jolla, Calif. 

Thomas Gut, DO: “It’s always impossible to predict the severity of COVID waves. Although the virus has generally mutated in ways that favor easier transmission and milder illness, there have been a handful of surprising mutations that were more dangerous and deadly than the preceding strain,” said Dr. Gut, associate chair of medicine at Staten Island University Hospital/Northwell Health in New York.

Robert Atmar, MD: “I’ll start with the caveat that prognosticating for SARS-CoV-2 is a bit hazardous as we remain in unknown territory for some aspects of its epidemiology and evolution,” said Dr. Atmar, a professor of infectious diseases at Baylor College of Medicine in Houston. “It depends on your definition of substantial. We, at least in Houston, are already in the midst of a substantial surge in the burden of infection, at least as monitored through wastewater surveillance. The amount of virus in the wastewater already exceeds the peak level we saw last winter. That said, the increased infection burden has not translated into large increases in hospitalizations for COVID-19. Most persons hospitalized in our hospital are admitted with infection, not for the consequences of infection.”

Stuart Campbell Ray, MD: “It looks like there is a rise in infections, but the proportional rise in hospitalizations from severe cases is lower than in the past, suggesting that folks are protected by the immunity we’ve gained over the past few years through vaccination and prior infections. Of course, we should be thinking about how that applies to each of us – how recently we had a vaccine or COVID-19, and whether we might see more severe infections as immunity wanes,” said Dr. Ray, who is a professor of medicine in the division of infectious diseases at Johns Hopkins University in Baltimore. 

Question 2: Is a return to masks or mask mandates coming this fall or winter?

Dr. Topol: “Mandating masks doesn’t work very well, but we may see wide use again if a descendant of [variant] BA.2.86 takes off.”

Dr. Gut: “It’s difficult to predict if there are any mask mandates returning at any point. Ever since the Omicron strains emerged, COVID has been relatively mild, compared to previous strains, so there probably won’t be any plan to start masking in public unless a more deadly strain appears.”

Dr. Atmar: “I do not think we will see a return to mask mandates this fall or winter for a variety of reasons. The primary one is that I don’t think the public will accept mask mandates. However, I think masking can continue to be an adjunctive measure to enhance protection from infection, along with booster vaccination.”

Dr. Ray: “Some people will choose to wear masks during a surge, particularly in situations like commuting where they don’t interfere with what they’re doing. They will wear masks particularly if they want to avoid infection due to concerns about others they care about, disruption of work or travel plans, or concerns about long-term consequences of repeated COVID-19.”

Question 3: Now that COVID testing and vaccinations are no longer free of charge, how might that affect their use?

Dr. Topol: “It was already low, and this will undoubtedly further compromise their uptake.”

Dr. Gut: “I do expect that testing will become less common now that tests are no longer free. I’m sure there will be a lower amount of detection in patients with milder or asymptomatic disease compared to what we had previously.”

Dr. Atmar: “If there are out-of-pocket costs for the SARS-CoV-2 vaccine, or if the administrative paperwork attached to getting a vaccine is increased, the uptake of SARS-CoV-2 vaccines will likely decrease. It will be important to communicate to the populations targeted for vaccination the potential benefits of such vaccination.”

Dr. Ray: “A challenge with COVID-19, all along, has been disparities in access to care, and this will be worse without public support for prevention and testing. This applies to everyone but is especially burdensome for those who are often marginalized in our health care system and society in general. I hope that we’ll find ways to ensure that people who need tests and vaccinations are able to access them, as good health is in everyone’s interest.”

Question 4: Will the new vaccines against COVID work for the currently circulating variants?

Dr. Topol: “The XBB.1.5 boosters will be out Sept. 14. They should help versus EG.5.1 and FL.1.5.1. The FL.1.5.1 variant is gaining now.”

Dr. Gut: “In the next several weeks, we expect the newer monovalent XBB-based vaccines to be offered that offer good protection against current circulating COVID variants along with the new Eris variant.”

Dr. Atmar: “The vaccines are expected to induce immune responses to the currently circulating variants, most of which are strains that evolved from the vaccine strain. The vaccine is expected to be most effective in preventing severe illness and will likely be less effective in preventing infection and mild illness.”

Dr. Ray: “Yes, the updated vaccine design has a spike antigen (XBB.1.5) nearly identical to the current dominant variant (EG.5). Even as variants change, the boosters stimulate B cells and T cells to help protect in a way that is safer than getting COVID-19 infection.”

Question 5: Is there anything we should watch out for regarding the BA.2.86 variant in particular?

Dr. Topol: “The scenario could change if there are new functional mutations added to it.”

Dr. Gut: “BA.2.86 is still fairly uncommon and does not have much data to directly make any informed guesses. However, in general, people that have been exposed to more recent mutations of the COVID virus have been shown to have more protection from newer upcoming mutations. It’s fair to guess that people that have not had recent infection from COVID, or have not had a recent booster, are at higher risk for being infected by any XBB- or BA.2-based strains.”

Dr. Atmar: BA.2.86 has been designated as a variant under monitoring. We will want to see whether it becomes more common and if there are any unexpected characteristics associated with infection by this variant.”

Dr. Ray: “It’s still rare, but it’s been seen in geographically dispersed places, so it’s got legs. The question is how effectively it will bypass some of the immunity we’ve gained. T cells are likely to remain protective, because they target so many parts of the virus that change more slowly, but antibodies from B cells to spike protein may have more trouble recognizing BA.2.86, whether those antibodies were made to a vaccine or a prior variant.”

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

COVID-19 hospitalizations have been on the rise for weeks as summer nears its end, but how concerned should you be? SARS-CoV-2, the virus behind COVID, continues to evolve and surprise us. So COVID transmission, hospitalization, and death rates can be difficult to predict. 

This news organization turned to the experts for their take on the current circulating virus, asking them to predict if we’ll be masking up again anytime soon, and what this fall and winter might look like, especially now that testing and vaccinations are no longer free of charge.
 

Question 1: Are you expecting an end-of-summer COVID wave to be substantial?

Eric Topol, MD: “This wave won’t likely be substantial and could be more of a ‘wavelet.’ I’m not thinking that physicians are too concerned,” said Dr. Topol, founder and director of Scripps Research Translational Institute in La Jolla, Calif. 

Thomas Gut, DO: “It’s always impossible to predict the severity of COVID waves. Although the virus has generally mutated in ways that favor easier transmission and milder illness, there have been a handful of surprising mutations that were more dangerous and deadly than the preceding strain,” said Dr. Gut, associate chair of medicine at Staten Island University Hospital/Northwell Health in New York.

Robert Atmar, MD: “I’ll start with the caveat that prognosticating for SARS-CoV-2 is a bit hazardous as we remain in unknown territory for some aspects of its epidemiology and evolution,” said Dr. Atmar, a professor of infectious diseases at Baylor College of Medicine in Houston. “It depends on your definition of substantial. We, at least in Houston, are already in the midst of a substantial surge in the burden of infection, at least as monitored through wastewater surveillance. The amount of virus in the wastewater already exceeds the peak level we saw last winter. That said, the increased infection burden has not translated into large increases in hospitalizations for COVID-19. Most persons hospitalized in our hospital are admitted with infection, not for the consequences of infection.”

Stuart Campbell Ray, MD: “It looks like there is a rise in infections, but the proportional rise in hospitalizations from severe cases is lower than in the past, suggesting that folks are protected by the immunity we’ve gained over the past few years through vaccination and prior infections. Of course, we should be thinking about how that applies to each of us – how recently we had a vaccine or COVID-19, and whether we might see more severe infections as immunity wanes,” said Dr. Ray, who is a professor of medicine in the division of infectious diseases at Johns Hopkins University in Baltimore. 

Question 2: Is a return to masks or mask mandates coming this fall or winter?

Dr. Topol: “Mandating masks doesn’t work very well, but we may see wide use again if a descendant of [variant] BA.2.86 takes off.”

Dr. Gut: “It’s difficult to predict if there are any mask mandates returning at any point. Ever since the Omicron strains emerged, COVID has been relatively mild, compared to previous strains, so there probably won’t be any plan to start masking in public unless a more deadly strain appears.”

Dr. Atmar: “I do not think we will see a return to mask mandates this fall or winter for a variety of reasons. The primary one is that I don’t think the public will accept mask mandates. However, I think masking can continue to be an adjunctive measure to enhance protection from infection, along with booster vaccination.”

Dr. Ray: “Some people will choose to wear masks during a surge, particularly in situations like commuting where they don’t interfere with what they’re doing. They will wear masks particularly if they want to avoid infection due to concerns about others they care about, disruption of work or travel plans, or concerns about long-term consequences of repeated COVID-19.”

Question 3: Now that COVID testing and vaccinations are no longer free of charge, how might that affect their use?

Dr. Topol: “It was already low, and this will undoubtedly further compromise their uptake.”

Dr. Gut: “I do expect that testing will become less common now that tests are no longer free. I’m sure there will be a lower amount of detection in patients with milder or asymptomatic disease compared to what we had previously.”

Dr. Atmar: “If there are out-of-pocket costs for the SARS-CoV-2 vaccine, or if the administrative paperwork attached to getting a vaccine is increased, the uptake of SARS-CoV-2 vaccines will likely decrease. It will be important to communicate to the populations targeted for vaccination the potential benefits of such vaccination.”

Dr. Ray: “A challenge with COVID-19, all along, has been disparities in access to care, and this will be worse without public support for prevention and testing. This applies to everyone but is especially burdensome for those who are often marginalized in our health care system and society in general. I hope that we’ll find ways to ensure that people who need tests and vaccinations are able to access them, as good health is in everyone’s interest.”

Question 4: Will the new vaccines against COVID work for the currently circulating variants?

Dr. Topol: “The XBB.1.5 boosters will be out Sept. 14. They should help versus EG.5.1 and FL.1.5.1. The FL.1.5.1 variant is gaining now.”

Dr. Gut: “In the next several weeks, we expect the newer monovalent XBB-based vaccines to be offered that offer good protection against current circulating COVID variants along with the new Eris variant.”

Dr. Atmar: “The vaccines are expected to induce immune responses to the currently circulating variants, most of which are strains that evolved from the vaccine strain. The vaccine is expected to be most effective in preventing severe illness and will likely be less effective in preventing infection and mild illness.”

Dr. Ray: “Yes, the updated vaccine design has a spike antigen (XBB.1.5) nearly identical to the current dominant variant (EG.5). Even as variants change, the boosters stimulate B cells and T cells to help protect in a way that is safer than getting COVID-19 infection.”

Question 5: Is there anything we should watch out for regarding the BA.2.86 variant in particular?

Dr. Topol: “The scenario could change if there are new functional mutations added to it.”

Dr. Gut: “BA.2.86 is still fairly uncommon and does not have much data to directly make any informed guesses. However, in general, people that have been exposed to more recent mutations of the COVID virus have been shown to have more protection from newer upcoming mutations. It’s fair to guess that people that have not had recent infection from COVID, or have not had a recent booster, are at higher risk for being infected by any XBB- or BA.2-based strains.”

Dr. Atmar: BA.2.86 has been designated as a variant under monitoring. We will want to see whether it becomes more common and if there are any unexpected characteristics associated with infection by this variant.”

Dr. Ray: “It’s still rare, but it’s been seen in geographically dispersed places, so it’s got legs. The question is how effectively it will bypass some of the immunity we’ve gained. T cells are likely to remain protective, because they target so many parts of the virus that change more slowly, but antibodies from B cells to spike protein may have more trouble recognizing BA.2.86, whether those antibodies were made to a vaccine or a prior variant.”

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

Severe COVID infections may lead to lasting damage to the immune system, new research finds.

The small study, published in Cell and funded by the National Institutes of Health, details how immune cells were analyzed through blood samples collected from 38 patients recovering from severe COVID and other critical illnesses, and from 19 healthy people. Researchers from Weill Cornell Medicine, New York, and The Jackson Laboratory for Genomic Medicine, Farmington, Conn., found through isolating hematopoietic stem cells that people recovering from severe bouts of COVID had changes to their DNA that were passed down to offspring cells.

The research team, led by Steven Josefowicz, PhD, of Weill Cornell’s pathology department, and Duygu Ucar, PhD, associate professor at The Jackson Laboratory for Genomic Medicine, discovered that this chain reaction of stem cell changes caused a boost in the production of monocytes. The authors found that, due to the innate cellular changes from a severe case of COVID, patients in recovery ended up producing a larger amount of inflammatory cytokines, rather than monocytes – distinct from samples collected from healthy patients and those recovering from other critical illnesses.

These changes to patients’ epigenetic landscapes were observed even a year after the initial COVID-19 infection. While the small participant pool meant that the research team could not establish a direct line between these innate changes and any ensuing health outcomes, the research provides us with clues as to why patients continue to struggle with inflammation and long COVID symptoms well after they recover.

While the authors reiterate the study’s limitations and hesitate to make any clear-cut associations between the results and long-term health outcomes, Wolfgang Leitner, PhD, from the NIH’s National Institute of Allergy and Infectious Diseases, predicts that long COVID can, at least in part, be explained by the changes in innate immune responses.

“Ideally, the authors would have had cells from each patient before they got infected, as a comparator, to see what the epigenetic landscape was before COVID changed it,” said Dr. Leitner. “Clear links between the severity of COVID and genetics were discovered already early in the pandemic and this paper should prompt follow-up studies that link mutations in immune genes with the epigenetic changes described here.”

Dr. Leitner said he had some initial predictions about the long-term impact of COVID-19, but he had not anticipated some of what the study’s findings now show.

“Unlike in the case of, for example, influenza, where the lungs go into ‘repair mode’ after the infection has been resolved – which leaves people susceptible to secondary infections for up to several months – this study shows that after severe COVID, the immune system remains in ‘emergency mode’ and in a heightened state of inflammation,” said Dr. Leitner.

“That further aggravates the problem the initial strong inflammation causes: even higher risk of autoimmune disease, but also, cancer.”

Commenting on the findings, Eric Topol, MD, editor-in-chief of Medscape Medical News, said the study presents “evidence that a key line of immune cells are essentially irrevocably, epigenetically altered and activated.

“You do not want to have this [COVID],” he added.

The study also highlights the researchers’ novel approach to isolating hematopoietic stem cells, found largely in bone marrow. This type of research has been limited in the past because of how costly and invasive it can be to analyze cells in bone marrow. But, by isolating and enriching hematopoietic stem cells, the team can decipher the full cellular diversity of the cells’ bone marrow counterparts.

“This revelation opened the doors to study, at single-cell resolution, how stem cells are affected upon infection and vaccination with a simple blood draw,” representatives from the Jackson lab said in a press release.

A version of this article appeared on Medscape.com.

Severe COVID infections may lead to lasting damage to the immune system, new research finds.

The small study, published in Cell and funded by the National Institutes of Health, details how immune cells were analyzed through blood samples collected from 38 patients recovering from severe COVID and other critical illnesses, and from 19 healthy people. Researchers from Weill Cornell Medicine, New York, and The Jackson Laboratory for Genomic Medicine, Farmington, Conn., found through isolating hematopoietic stem cells that people recovering from severe bouts of COVID had changes to their DNA that were passed down to offspring cells.

The research team, led by Steven Josefowicz, PhD, of Weill Cornell’s pathology department, and Duygu Ucar, PhD, associate professor at The Jackson Laboratory for Genomic Medicine, discovered that this chain reaction of stem cell changes caused a boost in the production of monocytes. The authors found that, due to the innate cellular changes from a severe case of COVID, patients in recovery ended up producing a larger amount of inflammatory cytokines, rather than monocytes – distinct from samples collected from healthy patients and those recovering from other critical illnesses.

These changes to patients’ epigenetic landscapes were observed even a year after the initial COVID-19 infection. While the small participant pool meant that the research team could not establish a direct line between these innate changes and any ensuing health outcomes, the research provides us with clues as to why patients continue to struggle with inflammation and long COVID symptoms well after they recover.

While the authors reiterate the study’s limitations and hesitate to make any clear-cut associations between the results and long-term health outcomes, Wolfgang Leitner, PhD, from the NIH’s National Institute of Allergy and Infectious Diseases, predicts that long COVID can, at least in part, be explained by the changes in innate immune responses.

“Ideally, the authors would have had cells from each patient before they got infected, as a comparator, to see what the epigenetic landscape was before COVID changed it,” said Dr. Leitner. “Clear links between the severity of COVID and genetics were discovered already early in the pandemic and this paper should prompt follow-up studies that link mutations in immune genes with the epigenetic changes described here.”

Dr. Leitner said he had some initial predictions about the long-term impact of COVID-19, but he had not anticipated some of what the study’s findings now show.

“Unlike in the case of, for example, influenza, where the lungs go into ‘repair mode’ after the infection has been resolved – which leaves people susceptible to secondary infections for up to several months – this study shows that after severe COVID, the immune system remains in ‘emergency mode’ and in a heightened state of inflammation,” said Dr. Leitner.

“That further aggravates the problem the initial strong inflammation causes: even higher risk of autoimmune disease, but also, cancer.”

Commenting on the findings, Eric Topol, MD, editor-in-chief of Medscape Medical News, said the study presents “evidence that a key line of immune cells are essentially irrevocably, epigenetically altered and activated.

“You do not want to have this [COVID],” he added.

The study also highlights the researchers’ novel approach to isolating hematopoietic stem cells, found largely in bone marrow. This type of research has been limited in the past because of how costly and invasive it can be to analyze cells in bone marrow. But, by isolating and enriching hematopoietic stem cells, the team can decipher the full cellular diversity of the cells’ bone marrow counterparts.

“This revelation opened the doors to study, at single-cell resolution, how stem cells are affected upon infection and vaccination with a simple blood draw,” representatives from the Jackson lab said in a press release.

A version of this article appeared on Medscape.com.

Severe COVID infections may lead to lasting damage to the immune system, new research finds.

The small study, published in Cell and funded by the National Institutes of Health, details how immune cells were analyzed through blood samples collected from 38 patients recovering from severe COVID and other critical illnesses, and from 19 healthy people. Researchers from Weill Cornell Medicine, New York, and The Jackson Laboratory for Genomic Medicine, Farmington, Conn., found through isolating hematopoietic stem cells that people recovering from severe bouts of COVID had changes to their DNA that were passed down to offspring cells.

The research team, led by Steven Josefowicz, PhD, of Weill Cornell’s pathology department, and Duygu Ucar, PhD, associate professor at The Jackson Laboratory for Genomic Medicine, discovered that this chain reaction of stem cell changes caused a boost in the production of monocytes. The authors found that, due to the innate cellular changes from a severe case of COVID, patients in recovery ended up producing a larger amount of inflammatory cytokines, rather than monocytes – distinct from samples collected from healthy patients and those recovering from other critical illnesses.

These changes to patients’ epigenetic landscapes were observed even a year after the initial COVID-19 infection. While the small participant pool meant that the research team could not establish a direct line between these innate changes and any ensuing health outcomes, the research provides us with clues as to why patients continue to struggle with inflammation and long COVID symptoms well after they recover.

While the authors reiterate the study’s limitations and hesitate to make any clear-cut associations between the results and long-term health outcomes, Wolfgang Leitner, PhD, from the NIH’s National Institute of Allergy and Infectious Diseases, predicts that long COVID can, at least in part, be explained by the changes in innate immune responses.

“Ideally, the authors would have had cells from each patient before they got infected, as a comparator, to see what the epigenetic landscape was before COVID changed it,” said Dr. Leitner. “Clear links between the severity of COVID and genetics were discovered already early in the pandemic and this paper should prompt follow-up studies that link mutations in immune genes with the epigenetic changes described here.”

Dr. Leitner said he had some initial predictions about the long-term impact of COVID-19, but he had not anticipated some of what the study’s findings now show.

“Unlike in the case of, for example, influenza, where the lungs go into ‘repair mode’ after the infection has been resolved – which leaves people susceptible to secondary infections for up to several months – this study shows that after severe COVID, the immune system remains in ‘emergency mode’ and in a heightened state of inflammation,” said Dr. Leitner.

“That further aggravates the problem the initial strong inflammation causes: even higher risk of autoimmune disease, but also, cancer.”

Commenting on the findings, Eric Topol, MD, editor-in-chief of Medscape Medical News, said the study presents “evidence that a key line of immune cells are essentially irrevocably, epigenetically altered and activated.

“You do not want to have this [COVID],” he added.

The study also highlights the researchers’ novel approach to isolating hematopoietic stem cells, found largely in bone marrow. This type of research has been limited in the past because of how costly and invasive it can be to analyze cells in bone marrow. But, by isolating and enriching hematopoietic stem cells, the team can decipher the full cellular diversity of the cells’ bone marrow counterparts.

“This revelation opened the doors to study, at single-cell resolution, how stem cells are affected upon infection and vaccination with a simple blood draw,” representatives from the Jackson lab said in a press release.

A version of this article appeared on Medscape.com.

By the end of August 2022, overall use of mental health services was almost 40% higher than before the COVID-19 pandemic, while spending increased by 54%, according to a new study by researchers at the RAND Corporation.

During the early phase of the pandemic, from mid-March to mid-December 2020, before the vaccine was available, in-person visits decreased by 40%, while telehealth visits increased by 1,000%, reported Jonathan H. Cantor, PhD, and colleagues at RAND, and at Castlight Health, a benefit coordination provider, in a paper published online in JAMA Health Forum.

Between December 2020 and August 2022, telehealth visits stayed stable, but in-person visits creeped back up, eventually reaching 80% of prepandemic levels. However, “total utilization was higher than before the pandemic,” Dr. Cantor, a policy researcher at RAND, told this news organization. 

“It could be that it’s easier for individuals to receive care via telehealth, but it could also just be that there’s a greater demand or need since the pandemic,” said Dr. Cantor. “We’ll just need more research to actually unpack what’s going on,” he said.

Initial per capita spending increased by about a third and was up overall by more than half. But it’s not clear how much of that is due to utilization or to price of services, said Dr. Cantor. Spending for telehealth services remained stable in the post-vaccine period, while spending on in-person visits returned to prepandemic levels.

Dr. Cantor and his colleagues were not able to determine whether utilization was by new or existing patients, but he said that would be good data to have. “It would be really important to know whether or not folks are initiating care because telehealth is making it easier,” he said.

The authors analyzed about 1.5 million claims for anxiety disorders, major depressive disorder, bipolar disorder, schizophrenia, and posttraumatic stress disorder, out of claims submitted by 7 million commercially insured adults whose self-insured employers used the Castlight benefit.

Dr. Cantor noted that this is just a small subset of the U.S. population. He said he’d like to have data from Medicare and Medicaid to fully assess the impact of the COVID-19 pandemic on mental health and of telehealth visits.

“This is a still-burgeoning field,” he said about telehealth. “We’re still trying to get a handle on how things are operating, given that there’s been so much change so rapidly.”

Meanwhile, 152 major employers responding to a large national survey this summer said that they’ve been grappling with how COVID-19 has affected workers. The employers include 72 Fortune 100 companies and provide health coverage for more than 60 million workers, retirees, and their families.

Seventy-seven percent said they are currently seeing an increase in depression, anxiety, and substance use disorders as a result of the pandemic, according to the Business Group on Health’s survey. That’s up from 44% in 2022.

Going forward, employers will focus on increasing access to mental health services, the survey reported.

“Our survey found that in 2024 and for the near future, employers will be acutely focused on addressing employees’ mental health needs while ensuring access and lowering cost barriers,” Ellen Kelsay, president and CEO of Business Group on Health, said in a statement.

The study was supported by grants from the National Institute of Mental Health and the National Institute on Aging. Coauthor Dena Bravata, MD, a Castlight employee, reported receiving personal fees from Castlight Health during the conduct of the study. Coauthor Christopher M. Whaley, a RAND employee, reported receiving personal fees from Castlight Health outside the submitted work.

A version of this article appeared on Medscape.com.

By the end of August 2022, overall use of mental health services was almost 40% higher than before the COVID-19 pandemic, while spending increased by 54%, according to a new study by researchers at the RAND Corporation.

During the early phase of the pandemic, from mid-March to mid-December 2020, before the vaccine was available, in-person visits decreased by 40%, while telehealth visits increased by 1,000%, reported Jonathan H. Cantor, PhD, and colleagues at RAND, and at Castlight Health, a benefit coordination provider, in a paper published online in JAMA Health Forum.

Between December 2020 and August 2022, telehealth visits stayed stable, but in-person visits creeped back up, eventually reaching 80% of prepandemic levels. However, “total utilization was higher than before the pandemic,” Dr. Cantor, a policy researcher at RAND, told this news organization. 

“It could be that it’s easier for individuals to receive care via telehealth, but it could also just be that there’s a greater demand or need since the pandemic,” said Dr. Cantor. “We’ll just need more research to actually unpack what’s going on,” he said.

Initial per capita spending increased by about a third and was up overall by more than half. But it’s not clear how much of that is due to utilization or to price of services, said Dr. Cantor. Spending for telehealth services remained stable in the post-vaccine period, while spending on in-person visits returned to prepandemic levels.

Dr. Cantor and his colleagues were not able to determine whether utilization was by new or existing patients, but he said that would be good data to have. “It would be really important to know whether or not folks are initiating care because telehealth is making it easier,” he said.

The authors analyzed about 1.5 million claims for anxiety disorders, major depressive disorder, bipolar disorder, schizophrenia, and posttraumatic stress disorder, out of claims submitted by 7 million commercially insured adults whose self-insured employers used the Castlight benefit.

Dr. Cantor noted that this is just a small subset of the U.S. population. He said he’d like to have data from Medicare and Medicaid to fully assess the impact of the COVID-19 pandemic on mental health and of telehealth visits.

“This is a still-burgeoning field,” he said about telehealth. “We’re still trying to get a handle on how things are operating, given that there’s been so much change so rapidly.”

Meanwhile, 152 major employers responding to a large national survey this summer said that they’ve been grappling with how COVID-19 has affected workers. The employers include 72 Fortune 100 companies and provide health coverage for more than 60 million workers, retirees, and their families.

Seventy-seven percent said they are currently seeing an increase in depression, anxiety, and substance use disorders as a result of the pandemic, according to the Business Group on Health’s survey. That’s up from 44% in 2022.

Going forward, employers will focus on increasing access to mental health services, the survey reported.

“Our survey found that in 2024 and for the near future, employers will be acutely focused on addressing employees’ mental health needs while ensuring access and lowering cost barriers,” Ellen Kelsay, president and CEO of Business Group on Health, said in a statement.

The study was supported by grants from the National Institute of Mental Health and the National Institute on Aging. Coauthor Dena Bravata, MD, a Castlight employee, reported receiving personal fees from Castlight Health during the conduct of the study. Coauthor Christopher M. Whaley, a RAND employee, reported receiving personal fees from Castlight Health outside the submitted work.

A version of this article appeared on Medscape.com.

By the end of August 2022, overall use of mental health services was almost 40% higher than before the COVID-19 pandemic, while spending increased by 54%, according to a new study by researchers at the RAND Corporation.

During the early phase of the pandemic, from mid-March to mid-December 2020, before the vaccine was available, in-person visits decreased by 40%, while telehealth visits increased by 1,000%, reported Jonathan H. Cantor, PhD, and colleagues at RAND, and at Castlight Health, a benefit coordination provider, in a paper published online in JAMA Health Forum.

Between December 2020 and August 2022, telehealth visits stayed stable, but in-person visits creeped back up, eventually reaching 80% of prepandemic levels. However, “total utilization was higher than before the pandemic,” Dr. Cantor, a policy researcher at RAND, told this news organization. 

“It could be that it’s easier for individuals to receive care via telehealth, but it could also just be that there’s a greater demand or need since the pandemic,” said Dr. Cantor. “We’ll just need more research to actually unpack what’s going on,” he said.

Initial per capita spending increased by about a third and was up overall by more than half. But it’s not clear how much of that is due to utilization or to price of services, said Dr. Cantor. Spending for telehealth services remained stable in the post-vaccine period, while spending on in-person visits returned to prepandemic levels.

Dr. Cantor and his colleagues were not able to determine whether utilization was by new or existing patients, but he said that would be good data to have. “It would be really important to know whether or not folks are initiating care because telehealth is making it easier,” he said.

The authors analyzed about 1.5 million claims for anxiety disorders, major depressive disorder, bipolar disorder, schizophrenia, and posttraumatic stress disorder, out of claims submitted by 7 million commercially insured adults whose self-insured employers used the Castlight benefit.

Dr. Cantor noted that this is just a small subset of the U.S. population. He said he’d like to have data from Medicare and Medicaid to fully assess the impact of the COVID-19 pandemic on mental health and of telehealth visits.

“This is a still-burgeoning field,” he said about telehealth. “We’re still trying to get a handle on how things are operating, given that there’s been so much change so rapidly.”

Meanwhile, 152 major employers responding to a large national survey this summer said that they’ve been grappling with how COVID-19 has affected workers. The employers include 72 Fortune 100 companies and provide health coverage for more than 60 million workers, retirees, and their families.

Seventy-seven percent said they are currently seeing an increase in depression, anxiety, and substance use disorders as a result of the pandemic, according to the Business Group on Health’s survey. That’s up from 44% in 2022.

Going forward, employers will focus on increasing access to mental health services, the survey reported.

“Our survey found that in 2024 and for the near future, employers will be acutely focused on addressing employees’ mental health needs while ensuring access and lowering cost barriers,” Ellen Kelsay, president and CEO of Business Group on Health, said in a statement.

The study was supported by grants from the National Institute of Mental Health and the National Institute on Aging. Coauthor Dena Bravata, MD, a Castlight employee, reported receiving personal fees from Castlight Health during the conduct of the study. Coauthor Christopher M. Whaley, a RAND employee, reported receiving personal fees from Castlight Health outside the submitted work.

A version of this article appeared on Medscape.com.

Survivors of out-of-hospital cardiac arrest (OHCA) without ST-segment elevation who were transported to the nearest hospital emergency department had outcomes similar to those of patients transported to specialist cardiac arrest centers, in the ARREST trial.

Both groups had the same 30-day survival, the primary outcome, as well as 3-month survival and neurologic outcomes.

“The take-home message is that this trial does not support transporting cardiac arrest patients direct to a cardiac arrest center in London; they would fare better going to their nearest emergency department,” senior author Simon R. Redwood, MD, principal investigator of ARREST, from Guy’s and St. Thomas’ NHS Trust Hospitals and King’s College, London, said during a press briefing. “These results may allow better resource allocation elsewhere.”

Importantly, this study excluded patients who clearly had myocardial infarction (MI), he stressed. Cardiac arrest can result from cardiac causes or from other events, including trauma, overdose, drowning, or electrocution, he noted.

On the other hand, patients with MI “will benefit from going straight to a heart attack center and having an attempt at reopening the artery,” he emphasized.

Tiffany Patterson, PhD, clinical lead of ARREST, with the same affiliations as Dr. Redwood, presented the trial findings at the annual congress of the European Society of Cardiology in Amsterdam, on Aug. 27. The study was simultaneously published online in The Lancet.

Observational studies of registry data suggest that postarrest care for patients resuscitated after cardiac arrest, without ST-segment elevation, may be best delivered in a specialized center, she noted.

The International Liaison Committee on Resuscitation called for a randomized clinical trial of patients resuscitated after cardiac arrest without ST-segment elevation to clarify this.

In the ARREST trial, among 800 patients with return of spontaneous circulation following OHCA without ST-segment elevation who were randomly assigned to be transported to specialized centers or an emergency department, there was no survival benefit, she summarized.

ARREST was “not simply a negative trial, but a new evidence-based starting point,” according to the trial discussant Lia Crotti, MD, PhD, IRCCS Istituto Auxologico Italiano and University Milano-Bicocca, Italy. 

She drew attention to two findings: First, among the 862 patients who were enrolled, whom paramedics judged as being without an obvious noncardiac cause of the cardiac arrest, “only 60% ended up having a cardiac cause for their cardiac arrest and only around one quarter of the total had coronary artery disease.”

The small number of patients who could have benefited from early access to a catheterization laboratory probably contributed to the negative result obtained in this trial, with the loss of statistical power, she said.

Second, London is a dense urban area with high-quality acute care hospitals, so the standard of care in the nearest emergency department may be not so different from that in cardiac arrest centers, she noted. Furthermore, four of the seven cardiac arrest centers have an emergency department, and some of the standard care patients may have been transported there.

“If the clinical trial would be extended to the entire country, including rural areas, maybe the result would be different,” she said.

The study authors acknowledge that the main limitation of this study was that “it was done across London with a dense population in a small geographic area,” and “the London Ambulance Service has rapid response times and short transit times and delivers high quality prehospital care, which could limit generalizability.”

Asked during the press conference here why the results were so different from the registry study findings, Dr. Redwood said, “We’ve seen time and time again that registry data think they are telling us the answer. They’re actually not.”

The session cochairs, Rudolf de Boer, MD, PhD, of Erasmus University Medical Centre, Rotterdam, the Netherlands, and Faiez Zannad, MD, PhD, from University of Lorraine–Vandoeuvre-lès-Nancy, France, each congratulated the researchers on a well-done study.

Dr. de Boer wanted to know whether, for example, 100% of these resuscitated OHCA patients without ST-segment elevation  had a cardiac cause, “Would results differ? Or is this just real life?” he asked. Dr. Patterson replied that the paramedics excluded obvious noncardiac causes and the findings were based on current facilities.

“Does this trial provide a definitive answer?” Dr. de Boer asked. Dr. Patterson replied that for the moment, subgroup analysis did not identify any subgroup that might benefit from expedited transport to a cardiac arrest center.

Dr. Zannad wanted to know how informed consent was obtained. Dr. Patterson noted that they have an excellent ethical committee that allowed them to undertake this research in vulnerable patients. Written informed consent was obtained from the patient once the initial emergency had passed if they had regained capacity.
 

Rationale and trial findings

“It’s very well established that early bystander CPR [cardiopulmonary resuscitation], early defibrillation, and advanced in-hospital care improves survival,” Dr. Redwood noted. “Despite this, only 1 in 10 survive to leave the hospital.”

Therefore, “a cardiac arrest center has been proposed as a way of improving outcome.” These centers have a catheterization laboratory, open 24 hours a day, 7 days a week, advanced critical care including advanced ventilation, temperature management of the patient, hemodynamic support, and neuroprognostication and rehab “because often these patients will have brain injury.

“There’s quite overwhelming registry data to suggest that these cardiac arrest centers improve outcome,” he said, “but these are limited by bias.”

Between January 2018 and December 2022, London Ambulance paramedics randomly assigned 862 patients who were successfully resuscitated and without a confirmed MI to be transported the nearest hospital emergency department or the catheterization laboratory in a cardiac arrest center.

Data were available for 822 participants. They had a mean age of 63 years, and 68% were male.

The primary endpoint, 30-day mortality, occurred in 258 (63%) of 411 participants in the cardiac arrest center group and in 258 (63%) of 412 in the standard care group (unadjusted risk ratio for survival, 1.00; 95% confidence interval [CI], 0.90-1.11; P = 0.96).

Mortality at 3 months was similar in both groups: 64% in the standard care group and 65% in the cardiac arrest center group.

Neurologic outcomes at discharge and 3 months were similar in both groups.

Eight (2%) of 414 patients in the cardiac arrest center group and three (1%) of 413 in the standard care group had serious adverse events, none of which were deemed related to the trial intervention.

A cardiac cause of arrest was identified in roughly 60% of patients in each group, and of these, roughly 42% were coronary causes, 33% were arrhythmia, and 17% were cardiomyopathy.

The median time from cardiac arrest to hospital arrival was 84 minutes in the cardiac arrest center group and 77 minutes in the standard care group.
 

“Surprising and important RCT evidence”

In an accompanying editorial, Carolina Malta Hansen, MD, PhD, University of Copenhagen, and colleagues wrote that “this study provides randomized trial evidence that in urban settings such as London, there is no survival advantage of a strategy of transporting patients who have been resuscitated to centres with specialty expertise in care of cardiac arrest.
“This result is surprising and important, since this complex and critically ill population would be expected to benefit from centres with more expertise.”

However, “it would be a mistake to conclude that the trial results apply to regions where local hospitals provide a lower quality of care than those in this trial,” they cautioned.

“Where does this leave the medical community, researchers, and society in general?” they asked rhetorically. “Prioritising a minimum standard of care at local hospitals caring for this population is at least as important as ensuring high-quality care or advanced treatment at tertiary centres.

“This trial also calls for more focus on the basics, including efforts to increase bystander cardiopulmonary resuscitation and early defibrillation, aspects of care that are currently being assessed in two ongoing clinical trials (NCT04660526 and NCT03835403) and are most strongly associated with improved survival, when coupled with high-quality prehospital care with trained staff and short response times,” they concluded.

The study was fully funded by the British Heart Foundation. The authors reported that they have no relevant financial disclosures. The financial disclosures of the editorialists are listed with the editorial.

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

Survivors of out-of-hospital cardiac arrest (OHCA) without ST-segment elevation who were transported to the nearest hospital emergency department had outcomes similar to those of patients transported to specialist cardiac arrest centers, in the ARREST trial.

Both groups had the same 30-day survival, the primary outcome, as well as 3-month survival and neurologic outcomes.

“The take-home message is that this trial does not support transporting cardiac arrest patients direct to a cardiac arrest center in London; they would fare better going to their nearest emergency department,” senior author Simon R. Redwood, MD, principal investigator of ARREST, from Guy’s and St. Thomas’ NHS Trust Hospitals and King’s College, London, said during a press briefing. “These results may allow better resource allocation elsewhere.”

Importantly, this study excluded patients who clearly had myocardial infarction (MI), he stressed. Cardiac arrest can result from cardiac causes or from other events, including trauma, overdose, drowning, or electrocution, he noted.

On the other hand, patients with MI “will benefit from going straight to a heart attack center and having an attempt at reopening the artery,” he emphasized.

Tiffany Patterson, PhD, clinical lead of ARREST, with the same affiliations as Dr. Redwood, presented the trial findings at the annual congress of the European Society of Cardiology in Amsterdam, on Aug. 27. The study was simultaneously published online in The Lancet.

Observational studies of registry data suggest that postarrest care for patients resuscitated after cardiac arrest, without ST-segment elevation, may be best delivered in a specialized center, she noted.

The International Liaison Committee on Resuscitation called for a randomized clinical trial of patients resuscitated after cardiac arrest without ST-segment elevation to clarify this.

In the ARREST trial, among 800 patients with return of spontaneous circulation following OHCA without ST-segment elevation who were randomly assigned to be transported to specialized centers or an emergency department, there was no survival benefit, she summarized.

ARREST was “not simply a negative trial, but a new evidence-based starting point,” according to the trial discussant Lia Crotti, MD, PhD, IRCCS Istituto Auxologico Italiano and University Milano-Bicocca, Italy. 

She drew attention to two findings: First, among the 862 patients who were enrolled, whom paramedics judged as being without an obvious noncardiac cause of the cardiac arrest, “only 60% ended up having a cardiac cause for their cardiac arrest and only around one quarter of the total had coronary artery disease.”

The small number of patients who could have benefited from early access to a catheterization laboratory probably contributed to the negative result obtained in this trial, with the loss of statistical power, she said.

Second, London is a dense urban area with high-quality acute care hospitals, so the standard of care in the nearest emergency department may be not so different from that in cardiac arrest centers, she noted. Furthermore, four of the seven cardiac arrest centers have an emergency department, and some of the standard care patients may have been transported there.

“If the clinical trial would be extended to the entire country, including rural areas, maybe the result would be different,” she said.

The study authors acknowledge that the main limitation of this study was that “it was done across London with a dense population in a small geographic area,” and “the London Ambulance Service has rapid response times and short transit times and delivers high quality prehospital care, which could limit generalizability.”

Asked during the press conference here why the results were so different from the registry study findings, Dr. Redwood said, “We’ve seen time and time again that registry data think they are telling us the answer. They’re actually not.”

The session cochairs, Rudolf de Boer, MD, PhD, of Erasmus University Medical Centre, Rotterdam, the Netherlands, and Faiez Zannad, MD, PhD, from University of Lorraine–Vandoeuvre-lès-Nancy, France, each congratulated the researchers on a well-done study.

Dr. de Boer wanted to know whether, for example, 100% of these resuscitated OHCA patients without ST-segment elevation  had a cardiac cause, “Would results differ? Or is this just real life?” he asked. Dr. Patterson replied that the paramedics excluded obvious noncardiac causes and the findings were based on current facilities.

“Does this trial provide a definitive answer?” Dr. de Boer asked. Dr. Patterson replied that for the moment, subgroup analysis did not identify any subgroup that might benefit from expedited transport to a cardiac arrest center.

Dr. Zannad wanted to know how informed consent was obtained. Dr. Patterson noted that they have an excellent ethical committee that allowed them to undertake this research in vulnerable patients. Written informed consent was obtained from the patient once the initial emergency had passed if they had regained capacity.
 

Rationale and trial findings

“It’s very well established that early bystander CPR [cardiopulmonary resuscitation], early defibrillation, and advanced in-hospital care improves survival,” Dr. Redwood noted. “Despite this, only 1 in 10 survive to leave the hospital.”

Therefore, “a cardiac arrest center has been proposed as a way of improving outcome.” These centers have a catheterization laboratory, open 24 hours a day, 7 days a week, advanced critical care including advanced ventilation, temperature management of the patient, hemodynamic support, and neuroprognostication and rehab “because often these patients will have brain injury.

“There’s quite overwhelming registry data to suggest that these cardiac arrest centers improve outcome,” he said, “but these are limited by bias.”

Between January 2018 and December 2022, London Ambulance paramedics randomly assigned 862 patients who were successfully resuscitated and without a confirmed MI to be transported the nearest hospital emergency department or the catheterization laboratory in a cardiac arrest center.

Data were available for 822 participants. They had a mean age of 63 years, and 68% were male.

The primary endpoint, 30-day mortality, occurred in 258 (63%) of 411 participants in the cardiac arrest center group and in 258 (63%) of 412 in the standard care group (unadjusted risk ratio for survival, 1.00; 95% confidence interval [CI], 0.90-1.11; P = 0.96).

Mortality at 3 months was similar in both groups: 64% in the standard care group and 65% in the cardiac arrest center group.

Neurologic outcomes at discharge and 3 months were similar in both groups.

Eight (2%) of 414 patients in the cardiac arrest center group and three (1%) of 413 in the standard care group had serious adverse events, none of which were deemed related to the trial intervention.

A cardiac cause of arrest was identified in roughly 60% of patients in each group, and of these, roughly 42% were coronary causes, 33% were arrhythmia, and 17% were cardiomyopathy.

The median time from cardiac arrest to hospital arrival was 84 minutes in the cardiac arrest center group and 77 minutes in the standard care group.
 

“Surprising and important RCT evidence”

In an accompanying editorial, Carolina Malta Hansen, MD, PhD, University of Copenhagen, and colleagues wrote that “this study provides randomized trial evidence that in urban settings such as London, there is no survival advantage of a strategy of transporting patients who have been resuscitated to centres with specialty expertise in care of cardiac arrest.
“This result is surprising and important, since this complex and critically ill population would be expected to benefit from centres with more expertise.”

However, “it would be a mistake to conclude that the trial results apply to regions where local hospitals provide a lower quality of care than those in this trial,” they cautioned.

“Where does this leave the medical community, researchers, and society in general?” they asked rhetorically. “Prioritising a minimum standard of care at local hospitals caring for this population is at least as important as ensuring high-quality care or advanced treatment at tertiary centres.

“This trial also calls for more focus on the basics, including efforts to increase bystander cardiopulmonary resuscitation and early defibrillation, aspects of care that are currently being assessed in two ongoing clinical trials (NCT04660526 and NCT03835403) and are most strongly associated with improved survival, when coupled with high-quality prehospital care with trained staff and short response times,” they concluded.

The study was fully funded by the British Heart Foundation. The authors reported that they have no relevant financial disclosures. The financial disclosures of the editorialists are listed with the editorial.

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

Survivors of out-of-hospital cardiac arrest (OHCA) without ST-segment elevation who were transported to the nearest hospital emergency department had outcomes similar to those of patients transported to specialist cardiac arrest centers, in the ARREST trial.

Both groups had the same 30-day survival, the primary outcome, as well as 3-month survival and neurologic outcomes.

“The take-home message is that this trial does not support transporting cardiac arrest patients direct to a cardiac arrest center in London; they would fare better going to their nearest emergency department,” senior author Simon R. Redwood, MD, principal investigator of ARREST, from Guy’s and St. Thomas’ NHS Trust Hospitals and King’s College, London, said during a press briefing. “These results may allow better resource allocation elsewhere.”

Importantly, this study excluded patients who clearly had myocardial infarction (MI), he stressed. Cardiac arrest can result from cardiac causes or from other events, including trauma, overdose, drowning, or electrocution, he noted.

On the other hand, patients with MI “will benefit from going straight to a heart attack center and having an attempt at reopening the artery,” he emphasized.

Tiffany Patterson, PhD, clinical lead of ARREST, with the same affiliations as Dr. Redwood, presented the trial findings at the annual congress of the European Society of Cardiology in Amsterdam, on Aug. 27. The study was simultaneously published online in The Lancet.

Observational studies of registry data suggest that postarrest care for patients resuscitated after cardiac arrest, without ST-segment elevation, may be best delivered in a specialized center, she noted.

The International Liaison Committee on Resuscitation called for a randomized clinical trial of patients resuscitated after cardiac arrest without ST-segment elevation to clarify this.

In the ARREST trial, among 800 patients with return of spontaneous circulation following OHCA without ST-segment elevation who were randomly assigned to be transported to specialized centers or an emergency department, there was no survival benefit, she summarized.

ARREST was “not simply a negative trial, but a new evidence-based starting point,” according to the trial discussant Lia Crotti, MD, PhD, IRCCS Istituto Auxologico Italiano and University Milano-Bicocca, Italy. 

She drew attention to two findings: First, among the 862 patients who were enrolled, whom paramedics judged as being without an obvious noncardiac cause of the cardiac arrest, “only 60% ended up having a cardiac cause for their cardiac arrest and only around one quarter of the total had coronary artery disease.”

The small number of patients who could have benefited from early access to a catheterization laboratory probably contributed to the negative result obtained in this trial, with the loss of statistical power, she said.

Second, London is a dense urban area with high-quality acute care hospitals, so the standard of care in the nearest emergency department may be not so different from that in cardiac arrest centers, she noted. Furthermore, four of the seven cardiac arrest centers have an emergency department, and some of the standard care patients may have been transported there.

“If the clinical trial would be extended to the entire country, including rural areas, maybe the result would be different,” she said.

The study authors acknowledge that the main limitation of this study was that “it was done across London with a dense population in a small geographic area,” and “the London Ambulance Service has rapid response times and short transit times and delivers high quality prehospital care, which could limit generalizability.”

Asked during the press conference here why the results were so different from the registry study findings, Dr. Redwood said, “We’ve seen time and time again that registry data think they are telling us the answer. They’re actually not.”

The session cochairs, Rudolf de Boer, MD, PhD, of Erasmus University Medical Centre, Rotterdam, the Netherlands, and Faiez Zannad, MD, PhD, from University of Lorraine–Vandoeuvre-lès-Nancy, France, each congratulated the researchers on a well-done study.

Dr. de Boer wanted to know whether, for example, 100% of these resuscitated OHCA patients without ST-segment elevation  had a cardiac cause, “Would results differ? Or is this just real life?” he asked. Dr. Patterson replied that the paramedics excluded obvious noncardiac causes and the findings were based on current facilities.

“Does this trial provide a definitive answer?” Dr. de Boer asked. Dr. Patterson replied that for the moment, subgroup analysis did not identify any subgroup that might benefit from expedited transport to a cardiac arrest center.

Dr. Zannad wanted to know how informed consent was obtained. Dr. Patterson noted that they have an excellent ethical committee that allowed them to undertake this research in vulnerable patients. Written informed consent was obtained from the patient once the initial emergency had passed if they had regained capacity.
 

Rationale and trial findings

“It’s very well established that early bystander CPR [cardiopulmonary resuscitation], early defibrillation, and advanced in-hospital care improves survival,” Dr. Redwood noted. “Despite this, only 1 in 10 survive to leave the hospital.”

Therefore, “a cardiac arrest center has been proposed as a way of improving outcome.” These centers have a catheterization laboratory, open 24 hours a day, 7 days a week, advanced critical care including advanced ventilation, temperature management of the patient, hemodynamic support, and neuroprognostication and rehab “because often these patients will have brain injury.

“There’s quite overwhelming registry data to suggest that these cardiac arrest centers improve outcome,” he said, “but these are limited by bias.”

Between January 2018 and December 2022, London Ambulance paramedics randomly assigned 862 patients who were successfully resuscitated and without a confirmed MI to be transported the nearest hospital emergency department or the catheterization laboratory in a cardiac arrest center.

Data were available for 822 participants. They had a mean age of 63 years, and 68% were male.

The primary endpoint, 30-day mortality, occurred in 258 (63%) of 411 participants in the cardiac arrest center group and in 258 (63%) of 412 in the standard care group (unadjusted risk ratio for survival, 1.00; 95% confidence interval [CI], 0.90-1.11; P = 0.96).

Mortality at 3 months was similar in both groups: 64% in the standard care group and 65% in the cardiac arrest center group.

Neurologic outcomes at discharge and 3 months were similar in both groups.

Eight (2%) of 414 patients in the cardiac arrest center group and three (1%) of 413 in the standard care group had serious adverse events, none of which were deemed related to the trial intervention.

A cardiac cause of arrest was identified in roughly 60% of patients in each group, and of these, roughly 42% were coronary causes, 33% were arrhythmia, and 17% were cardiomyopathy.

The median time from cardiac arrest to hospital arrival was 84 minutes in the cardiac arrest center group and 77 minutes in the standard care group.
 

“Surprising and important RCT evidence”

In an accompanying editorial, Carolina Malta Hansen, MD, PhD, University of Copenhagen, and colleagues wrote that “this study provides randomized trial evidence that in urban settings such as London, there is no survival advantage of a strategy of transporting patients who have been resuscitated to centres with specialty expertise in care of cardiac arrest.
“This result is surprising and important, since this complex and critically ill population would be expected to benefit from centres with more expertise.”

However, “it would be a mistake to conclude that the trial results apply to regions where local hospitals provide a lower quality of care than those in this trial,” they cautioned.

“Where does this leave the medical community, researchers, and society in general?” they asked rhetorically. “Prioritising a minimum standard of care at local hospitals caring for this population is at least as important as ensuring high-quality care or advanced treatment at tertiary centres.

“This trial also calls for more focus on the basics, including efforts to increase bystander cardiopulmonary resuscitation and early defibrillation, aspects of care that are currently being assessed in two ongoing clinical trials (NCT04660526 and NCT03835403) and are most strongly associated with improved survival, when coupled with high-quality prehospital care with trained staff and short response times,” they concluded.

The study was fully funded by the British Heart Foundation. The authors reported that they have no relevant financial disclosures. The financial disclosures of the editorialists are listed with the editorial.

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

Patients with acute myocardial infarction (MI) and shock are often put on extracorporeal membrane oxygenation (ECMO) support before heading to the catheterization laboratory. But the practice, done routinely, doesn’t have much backing from randomized trials. Now it’s being challenged by one of the largest such studies to explore the issue.

In a new multicenter trial, there was no survival advantage at 30 days to early use of ECMO in such patients with cardiogenic shock, compared with a usual-care medical approach. ECMO-managed patients, moreover, had sharply increased risks for moderate and severe bleeding and vascular complications.
 

A challenge to common practice

The results undercut guidelines that promote mechanical circulatory support in MI-related cardiogenic shock primarily based on observational data, and they argue against what’s become common practice, said Holger Thiele, MD, Heart Center Leipzig, University of Leipzig, Germany.

Such use of ECMO could well offer some type of advantage in MI-related shock, but the data so far don’t show it, Dr. Thiele said at a press conference on the new study, called ECLS-SHOCK, at the annual congress of the European Society of Cardiology in Amsterdam. He formally presented the trial at the meeting and is lead author on its simultaneous publication in The New England Journal of Medicine.

Almost half of the trial’s patients died, whether or not they had been put on ECMO. All-cause mortality at 30 days, the primary endpoint, was about the same, at 47.8% and 49.0% for the ECMO and usual-care groups, respectively.

Meanwhile, Dr. Thiele reported, risks for moderate or severe bleeding more than doubled and serious peripheral vascular complications almost tripled with addition of ECMO support.

The findings, he noted, are consistent with a new meta-analysis of trials testing ECMO in MI-related shock that also showed increases in bleeding with survival gains using the devices. Dr. Thiele is senior author on that report, published in The Lancet to coincide with his ECLS-SHOCK presentation.
 

Would any subgroups benefit?

Importantly, he said in an interview, ECMO’s failure to improve 30-day survival in the trial probably applies across the spectrum of patients with MI-related shock. Subgroup analyses in both ECLS-SHOCK and the meta-analysis didn’t identify any groups that benefit, Dr. Thiele observed.

For example, there were no significant differences for the primary outcome by age, sex, whether the MI was ST-segment elevation MI or non–ST-segment elevation MI or anterior or nonanterior, or whether the patient had diabetes.

If there is a subgroup in MI-related shock that is likely to benefit from the intervention with lower mortality, he said, “it’s less than 1%, if you ask me.”

An accompanying editorial essentially agreed, arguing that ECLS-SHOCK contests the intervention’s broad application in MI-related shock without shedding light on any selective benefits.

“Will the results of the ECLS-SHOCK trial change current clinical practice? If the goal of [ECMO] is to improve 30-day mortality, these data should steer interventional and critical care cardiologists away from its early routine implementation for all or even most patients with myocardial infarction and cardiogenic shock,” the editorialists say.

“There will be some patients in this population for whom [ECMO] is necessary and lifesaving, but the results of the ECLS-SHOCK trial do not tell us which ones,” write Jane A. Leopold, MD, Brigham and Women’s Hospital, Boston, and Darren B. Taichman, MD, PhD, Penn Presbyterian Medical Center, Philadelphia.

“For now, the best course may be to reserve the early initiation of [ECMO] for those patients with infarct-related cardiogenic shock in whom the likely benefits more clearly outweigh the potential harms. We need further studies to tell us who they are,” write Dr. Leopold and Dr. Taichman, who are deputy editors with The New England Journal of Medicine.

ECLS-SHOCK randomly assigned 420 patients with acute MI complicated by shock and slated for coronary revascularization to receive standard care with or without early ECMO at 44 centers in Germany and Slovenia. Their median age was 63 years, and about 81% were men.

The relative risk for death from any cause, ECMO vs. usual care, was flatly nonsignificant at 0.98 (95% confidence interval, 0.80-1.19; P = .81).

ECMO came at the cost of significantly more cases of the primary safety endpoint, moderate or severe bleeding by Bleeding Academic Research Consortium criteria. That endpoint was met by 23.4% of ECMO patients and 9.6% of the control group, for an RR of 2.44 (95% CI, 1.50-3.95).

Rates of stroke or systemic embolization were nonsignificantly different at 3.8% and 2.9%, respectively (RR, 1.33; 95% CI, 0.47-3.76).

Speaking with this news organization, Sripal Bangalore, MD, MHA, pointed out that only 5.8% of the ECMO group but about 32% of those managed with usual care received some form of left ventricular (LV) unloading therapy.

Such measures can include atrial septostomy or the addition of an intra-aortic balloon pump or percutaneous LV-assist pump.

Given that ECMO increases afterload, “which is physiologically detrimental in patients with an ongoing MI, one is left to wonder if the results would have been different with greater use of LV unloading,” said Dr. Bangalore, of NYU Langone Health, New York, who isn’t associated with ECLS-SHOCK.

Also, he pointed out, about 78% of the trial’s patients had experienced some degree of cardiopulmonary resuscitation despite exclusion of anyone who had undergone it for more than 45 minutes. That may make the study more generalizable but also harder to show a benefit from ECMO. “The overall prognosis of that subset of patients despite heroic efforts is bleak at best.”

Dr. Thiele had no disclosures; statements for the other authors can be found at nejm.org. Dr. Bangalore has previously disclosed financial relationships with Abbott Vascular, Amgen, Biotronik, Inari, Pfizer, Reata, and Truvic. Dr. Leopold reports grants from Astellas and personal fees from United Therapeutics, Abbott Vascular, and North America Thrombosis Forum. Dr. Leopold and Dr. Taichman both report employment by The New England Journal of Medicine.

A version of this article appeared on Medscape.com.

Patients with acute myocardial infarction (MI) and shock are often put on extracorporeal membrane oxygenation (ECMO) support before heading to the catheterization laboratory. But the practice, done routinely, doesn’t have much backing from randomized trials. Now it’s being challenged by one of the largest such studies to explore the issue.

In a new multicenter trial, there was no survival advantage at 30 days to early use of ECMO in such patients with cardiogenic shock, compared with a usual-care medical approach. ECMO-managed patients, moreover, had sharply increased risks for moderate and severe bleeding and vascular complications.
 

A challenge to common practice

The results undercut guidelines that promote mechanical circulatory support in MI-related cardiogenic shock primarily based on observational data, and they argue against what’s become common practice, said Holger Thiele, MD, Heart Center Leipzig, University of Leipzig, Germany.

Such use of ECMO could well offer some type of advantage in MI-related shock, but the data so far don’t show it, Dr. Thiele said at a press conference on the new study, called ECLS-SHOCK, at the annual congress of the European Society of Cardiology in Amsterdam. He formally presented the trial at the meeting and is lead author on its simultaneous publication in The New England Journal of Medicine.

Almost half of the trial’s patients died, whether or not they had been put on ECMO. All-cause mortality at 30 days, the primary endpoint, was about the same, at 47.8% and 49.0% for the ECMO and usual-care groups, respectively.

Meanwhile, Dr. Thiele reported, risks for moderate or severe bleeding more than doubled and serious peripheral vascular complications almost tripled with addition of ECMO support.

The findings, he noted, are consistent with a new meta-analysis of trials testing ECMO in MI-related shock that also showed increases in bleeding with survival gains using the devices. Dr. Thiele is senior author on that report, published in The Lancet to coincide with his ECLS-SHOCK presentation.
 

Would any subgroups benefit?

Importantly, he said in an interview, ECMO’s failure to improve 30-day survival in the trial probably applies across the spectrum of patients with MI-related shock. Subgroup analyses in both ECLS-SHOCK and the meta-analysis didn’t identify any groups that benefit, Dr. Thiele observed.

For example, there were no significant differences for the primary outcome by age, sex, whether the MI was ST-segment elevation MI or non–ST-segment elevation MI or anterior or nonanterior, or whether the patient had diabetes.

If there is a subgroup in MI-related shock that is likely to benefit from the intervention with lower mortality, he said, “it’s less than 1%, if you ask me.”

An accompanying editorial essentially agreed, arguing that ECLS-SHOCK contests the intervention’s broad application in MI-related shock without shedding light on any selective benefits.

“Will the results of the ECLS-SHOCK trial change current clinical practice? If the goal of [ECMO] is to improve 30-day mortality, these data should steer interventional and critical care cardiologists away from its early routine implementation for all or even most patients with myocardial infarction and cardiogenic shock,” the editorialists say.

“There will be some patients in this population for whom [ECMO] is necessary and lifesaving, but the results of the ECLS-SHOCK trial do not tell us which ones,” write Jane A. Leopold, MD, Brigham and Women’s Hospital, Boston, and Darren B. Taichman, MD, PhD, Penn Presbyterian Medical Center, Philadelphia.

“For now, the best course may be to reserve the early initiation of [ECMO] for those patients with infarct-related cardiogenic shock in whom the likely benefits more clearly outweigh the potential harms. We need further studies to tell us who they are,” write Dr. Leopold and Dr. Taichman, who are deputy editors with The New England Journal of Medicine.

ECLS-SHOCK randomly assigned 420 patients with acute MI complicated by shock and slated for coronary revascularization to receive standard care with or without early ECMO at 44 centers in Germany and Slovenia. Their median age was 63 years, and about 81% were men.

The relative risk for death from any cause, ECMO vs. usual care, was flatly nonsignificant at 0.98 (95% confidence interval, 0.80-1.19; P = .81).

ECMO came at the cost of significantly more cases of the primary safety endpoint, moderate or severe bleeding by Bleeding Academic Research Consortium criteria. That endpoint was met by 23.4% of ECMO patients and 9.6% of the control group, for an RR of 2.44 (95% CI, 1.50-3.95).

Rates of stroke or systemic embolization were nonsignificantly different at 3.8% and 2.9%, respectively (RR, 1.33; 95% CI, 0.47-3.76).

Speaking with this news organization, Sripal Bangalore, MD, MHA, pointed out that only 5.8% of the ECMO group but about 32% of those managed with usual care received some form of left ventricular (LV) unloading therapy.

Such measures can include atrial septostomy or the addition of an intra-aortic balloon pump or percutaneous LV-assist pump.

Given that ECMO increases afterload, “which is physiologically detrimental in patients with an ongoing MI, one is left to wonder if the results would have been different with greater use of LV unloading,” said Dr. Bangalore, of NYU Langone Health, New York, who isn’t associated with ECLS-SHOCK.

Also, he pointed out, about 78% of the trial’s patients had experienced some degree of cardiopulmonary resuscitation despite exclusion of anyone who had undergone it for more than 45 minutes. That may make the study more generalizable but also harder to show a benefit from ECMO. “The overall prognosis of that subset of patients despite heroic efforts is bleak at best.”

Dr. Thiele had no disclosures; statements for the other authors can be found at nejm.org. Dr. Bangalore has previously disclosed financial relationships with Abbott Vascular, Amgen, Biotronik, Inari, Pfizer, Reata, and Truvic. Dr. Leopold reports grants from Astellas and personal fees from United Therapeutics, Abbott Vascular, and North America Thrombosis Forum. Dr. Leopold and Dr. Taichman both report employment by The New England Journal of Medicine.

A version of this article appeared on Medscape.com.

Patients with acute myocardial infarction (MI) and shock are often put on extracorporeal membrane oxygenation (ECMO) support before heading to the catheterization laboratory. But the practice, done routinely, doesn’t have much backing from randomized trials. Now it’s being challenged by one of the largest such studies to explore the issue.

In a new multicenter trial, there was no survival advantage at 30 days to early use of ECMO in such patients with cardiogenic shock, compared with a usual-care medical approach. ECMO-managed patients, moreover, had sharply increased risks for moderate and severe bleeding and vascular complications.
 

A challenge to common practice

The results undercut guidelines that promote mechanical circulatory support in MI-related cardiogenic shock primarily based on observational data, and they argue against what’s become common practice, said Holger Thiele, MD, Heart Center Leipzig, University of Leipzig, Germany.

Such use of ECMO could well offer some type of advantage in MI-related shock, but the data so far don’t show it, Dr. Thiele said at a press conference on the new study, called ECLS-SHOCK, at the annual congress of the European Society of Cardiology in Amsterdam. He formally presented the trial at the meeting and is lead author on its simultaneous publication in The New England Journal of Medicine.

Almost half of the trial’s patients died, whether or not they had been put on ECMO. All-cause mortality at 30 days, the primary endpoint, was about the same, at 47.8% and 49.0% for the ECMO and usual-care groups, respectively.

Meanwhile, Dr. Thiele reported, risks for moderate or severe bleeding more than doubled and serious peripheral vascular complications almost tripled with addition of ECMO support.

The findings, he noted, are consistent with a new meta-analysis of trials testing ECMO in MI-related shock that also showed increases in bleeding with survival gains using the devices. Dr. Thiele is senior author on that report, published in The Lancet to coincide with his ECLS-SHOCK presentation.
 

Would any subgroups benefit?

Importantly, he said in an interview, ECMO’s failure to improve 30-day survival in the trial probably applies across the spectrum of patients with MI-related shock. Subgroup analyses in both ECLS-SHOCK and the meta-analysis didn’t identify any groups that benefit, Dr. Thiele observed.

For example, there were no significant differences for the primary outcome by age, sex, whether the MI was ST-segment elevation MI or non–ST-segment elevation MI or anterior or nonanterior, or whether the patient had diabetes.

If there is a subgroup in MI-related shock that is likely to benefit from the intervention with lower mortality, he said, “it’s less than 1%, if you ask me.”

An accompanying editorial essentially agreed, arguing that ECLS-SHOCK contests the intervention’s broad application in MI-related shock without shedding light on any selective benefits.

“Will the results of the ECLS-SHOCK trial change current clinical practice? If the goal of [ECMO] is to improve 30-day mortality, these data should steer interventional and critical care cardiologists away from its early routine implementation for all or even most patients with myocardial infarction and cardiogenic shock,” the editorialists say.

“There will be some patients in this population for whom [ECMO] is necessary and lifesaving, but the results of the ECLS-SHOCK trial do not tell us which ones,” write Jane A. Leopold, MD, Brigham and Women’s Hospital, Boston, and Darren B. Taichman, MD, PhD, Penn Presbyterian Medical Center, Philadelphia.

“For now, the best course may be to reserve the early initiation of [ECMO] for those patients with infarct-related cardiogenic shock in whom the likely benefits more clearly outweigh the potential harms. We need further studies to tell us who they are,” write Dr. Leopold and Dr. Taichman, who are deputy editors with The New England Journal of Medicine.

ECLS-SHOCK randomly assigned 420 patients with acute MI complicated by shock and slated for coronary revascularization to receive standard care with or without early ECMO at 44 centers in Germany and Slovenia. Their median age was 63 years, and about 81% were men.

The relative risk for death from any cause, ECMO vs. usual care, was flatly nonsignificant at 0.98 (95% confidence interval, 0.80-1.19; P = .81).

ECMO came at the cost of significantly more cases of the primary safety endpoint, moderate or severe bleeding by Bleeding Academic Research Consortium criteria. That endpoint was met by 23.4% of ECMO patients and 9.6% of the control group, for an RR of 2.44 (95% CI, 1.50-3.95).

Rates of stroke or systemic embolization were nonsignificantly different at 3.8% and 2.9%, respectively (RR, 1.33; 95% CI, 0.47-3.76).

Speaking with this news organization, Sripal Bangalore, MD, MHA, pointed out that only 5.8% of the ECMO group but about 32% of those managed with usual care received some form of left ventricular (LV) unloading therapy.

Such measures can include atrial septostomy or the addition of an intra-aortic balloon pump or percutaneous LV-assist pump.

Given that ECMO increases afterload, “which is physiologically detrimental in patients with an ongoing MI, one is left to wonder if the results would have been different with greater use of LV unloading,” said Dr. Bangalore, of NYU Langone Health, New York, who isn’t associated with ECLS-SHOCK.

Also, he pointed out, about 78% of the trial’s patients had experienced some degree of cardiopulmonary resuscitation despite exclusion of anyone who had undergone it for more than 45 minutes. That may make the study more generalizable but also harder to show a benefit from ECMO. “The overall prognosis of that subset of patients despite heroic efforts is bleak at best.”

Dr. Thiele had no disclosures; statements for the other authors can be found at nejm.org. Dr. Bangalore has previously disclosed financial relationships with Abbott Vascular, Amgen, Biotronik, Inari, Pfizer, Reata, and Truvic. Dr. Leopold reports grants from Astellas and personal fees from United Therapeutics, Abbott Vascular, and North America Thrombosis Forum. Dr. Leopold and Dr. Taichman both report employment by The New England Journal of Medicine.

A version of this article appeared on Medscape.com.