MDedge Emergency Medicine

A recent Medscape survey found there were high levels of loneliness, stress, and burnout in physicians during the COVID-19 pandemic. Isolation and relationship stress add to the problem.

Patrick Ross, MD, a critical care physician at Children’s Hospital of Los Angeles, was plagued with increasing worry about his health and that of his family, patients, and colleagues. While distancing from his wife and daughter, he became terrified of falling ill and dying alone.

As he grew more anxious, Ross withdrew from family, colleagues, and friends, although his clinical and academic responsibilities were unaffected. He barely ate; his weight plummeted, and he began to have suicidal thoughts.

Rebecca Margolis, DO, a pediatric anesthesiologist whom Ross was mentoring, noticed something was amiss and suggested that he go to a therapist. That suggestion may have saved him.

“Once I started therapy, I no longer had suicidal ideations, but I still remained anxious on a day-to-day basis,” said Ross, who is an associate professor of clinical anesthesiology and pediatrics at the University of Southern California, Los Angeles. “As soon as I learned to manage or mitigate the anxiety, I was no longer consumed to the degree I had been by the sense of day-to-day threat.”

Ross openly shares his story because “many other physicians may be going through versions of what I experienced, and I want to encourage them to get help if they’re feeling stressed, anxious, lonely, depressed, or burned out, and to recognize that they are not alone.”
 

Physicians feel a sense of betrayal

Ross’ experience, although extreme, is not unique. According to a Medscape survey of almost 7,500 physicians, about two-thirds (64%) of U.S. physicians reported experiencing more intense burnout, and close to half (46%) reported feeling more lonely and isolated during the pandemic.

“We know that stress, which was already significant in physicians, has increased dramatically for many physicians during the pandemic. That’s understandable, given the circumstances they’ve been working under,” said Christine A. Sinsky, MD, vice president of professional satisfaction at the American Medical Association.

Physicians are stressed about potentially contracting the virus or infecting family members; being overworked and fatigued; witnessing wrenching scenes of patients dying alone; grieving the loss of patients, colleagues, or family members; and sometimes lacking adequate personal protective equipment (PPE), she said.

Lack of PPE has been identified as one of the most significant contributors to burnout and stress among physicians and other health care professionals. In all eight countries surveyed by Medscape, a significant number of respondents reported lacking appropriate PPE “sometimes,” “often,” or “always” when treating COVID-19 patients. Only 54% of U.S. respondents said they were always adequately protected.

The PPE shortage not only jeopardizes physical health but also has a negative effect on mental health and morale. A U.S.-based rheumatologist said, “The fact that we were sent to take care of infectious patients without proper PPE makes me feel we were betrayed in this fight.”
 

Not what they signed up for

Many physicians expressed fear regarding their personal safety, but that was often superseded by concern for family – especially elderly relatives or young children. (Medscape’s survey found that 9% of US respondents had immediate family members who had been diagnosed with COVID-19.)

Larissa Thomas, MD, MPH, University of California, San Francisco, said her greatest fear was bringing the virus home to her new baby and other vulnerable family members. Thomas is associate clinical professor of medicine and is a faculty hospitalist at Zuckerberg San Francisco General Hospital.

“Although physicians assume risk in our work, we didn’t sign up to care for patients without adequate protection, and our families certainly didn’t sign up for that risk, so the concern was acutely stressful,” said Thomas, who is also associate program director for the UCSF Internal Medicine Residency Program and is director of well-being for UCSF Graduate Medical Education.

The impact of stay-at-home restrictions on family members’ mental health also affected many physicians.

David Marcus, MD, residency director of the Combined Program in Emergency/Internal/Critical Care Medicine and chair of the GME Physician Wellbeing Committee at Northwell Health, Long Island, New York, said that a large stressor during the pandemic was having an elderly father with multiple comorbidities who lived alone and was unable to go out because of stay-at-home restrictions.

“I was worried not only for his physical health but also that his cognition might slip due to lack of socialization,” said Marcus.

Marcus was also worried about his preschool-age daughter, who seemed to be regressing and becoming desocialized from no longer being at school. “Fortunately, school has reopened, but it was a constant weight on my wife and me to see the impact of the lockdown on her development,” he said.
 

New situations create more anxiety

Being redeployed to new clinical roles in settings such as the emergency department or intensive care, which were not in their area of specialty, created much stress for physicians, Thomas said.

Physicians in private practice also had to adjust to new ways of practicing. In Medscape’s survey, 39% of U.S. physicians reported that their medical practice never closed during the pandemic. Keeping a practice open often meant learning to see patients virtually or becoming extremely vigilant about reducing the risk for contagion when seeing patients in person.
 

Relationships became more challenging

Social distancing during the pandemic had a negative effect on personal relationships for 44% of respondents, both in the United States and abroad.

One physician described her relationship with her partner as “more stressful” and argumentative. A rheumatologist reported experiencing frustration at having college-aged children living at home. Another respondent said that being with young children 24/7 left her “short-tempered,” and an emergency medicine physician respondent said she and her family were “driving each other crazy.”

Social distancing was not the only challenge to relationships. An orthopedist identified long, taxing work hours as contributing to a “decline in spousal harmony.”

On the other hand, some physicians said their relationships improved by developing shared insight. An emergency medicine physician wrote that he and his wife were “having more quarrels” but were “trying very hard and succeeding at understanding that much of this is due to the changes in our living situation.”

As a volunteer with New York City’s Medical Reserve Corps, Wilfrid Noel Raby, PhD, MD, adjunct clinical professor of psychiatry, Albert Einstein College of Medicine, New York City, chose to keep his Teaneck, New Jersey–based office open and was taking overnight shifts at Lincoln Hospital in New York City during the acute physician shortage. “After my regular hospital job treating psychiatric patients and seeing patients in my private practice, I sometimes pulled 12-hour nights caring for very ill patients. It was grueling, and I came home drained and exhausted,” he recalled.

Raby’s wife, a surgical nurse, had been redeployed to care for COVID-19 patients in the ICU – a situation she found grueling as well. Adding to the stress were the “rigorous distancing and sanitation precautions we needed to practice at home.” Fear of contagion, together with exhaustion, resulted in “occasional moments of friction,” Raby acknowledged.

Still, some physicians managed to find a bit of a silver lining. “We tried to relax, get as much sleep as possible, and keep things simple, not taking on extra tasks that could be postponed,” Raby said. “It helped that we both recognized how difficult it was to reassure each other when we were stressed and scared, so we faced the crisis together, and I think it ultimately brought us closer.”

Thomas said that the pandemic has helped her to recognize what she can and cannot control and how to take things one day at a time.

“When my husband and I can both work from home, we are grateful to have that ability and grateful for the things that we do have. These small moments of gratitude have sustained us day to day,” Thomas said.
 

Socializing outside the box

Several physicians expressed a sense of loneliness because stay-at-home guidelines and social distancing prevented them from socializing with friends. In all countries, physician respondents to the Medscape survey reported feeling “more lonely” than prior to the pandemic. Over half (51%) of Portuguese physicians reported feeling lonelier; 48% of physicians in Brazil felt that way. The United States came in third, at 46%.

Many physicians feel cut off, even from other physicians, and are reluctant to share feelings of distress.

“Talking to colleagues about distress is an important human connection,” Margolis emphasized. “We need to rely on each other to commiserate and receive validation and comfort.”

Some institutions have formalized this process by instituting a “battle buddy” model – a term borrowed from the military – which involves pairing clinicians of similar specialty, career stage, and life circumstances to provide mutual peer support, Margolis said. A partner who notices concerning signs in the other partner can refer the person to resources for help.

Sinsky said that an organization called PeerRxMed offers physicians a chance to sign up for a “buddy,” even outside their own institution.
 

The importance of ‘fixing’ the workplace

Close to half (43%) of U.S. respondents to Medscape’s survey reported that their workplace offers activities to help physicians deal with grief and stress, but 39% said that their workplace does not offer this type of support, and 18% were not sure whether these services were offered.

At times of crisis, organizations need to offer “stress first aid,” Sinsky said. This includes providing for basic needs, such as child care, transportation, and healthy food, and having “open, transparent, and honest communication” from leadership regarding what is known and not known about the pandemic, clinician responsibilities, and stress reduction measures.

Marcus notes that, at his institution, psychiatric residents and other members of the psychiatry department have “stepped up and crafted process groups and peer support contexts to debrief, engage, explore productive outlets for feelings, and facilitate communication.” In particular, residents have found cognitive-behavioral therapy to be useful.

Despite the difficult situation, seeking help can be challenging for some physicians. One reason, Marcus says, is that doctors tend to think of themselves as being at the giving rather than the receiving end of help – especially during a crisis. “We do what we need to do, and we often don’t see the toll it takes on us,” he noted. Moreover, the pressure to be at the “giving” end can lead to stigma in acknowledging vulnerability.

Ross said he hopes his story will help to destigmatize reaching out for help. “It is possible that a silver lining of this terrible crisis is to normalize physicians receiving help for mental health issues.”

Marcus likewise openly shares his own experiences about struggles with burnout and depressive symptoms. “As a physician educator, I think it’s important for me to be public about these things, which validates help-seeking for residents and colleagues.”

For physicians seeking help not offered in their workplace, the Physician Support Line is a useful resource, added Margolis. She noted that its services are free and confidential.

This article first appeared on Medscape.com.

A recent Medscape survey found there were high levels of loneliness, stress, and burnout in physicians during the COVID-19 pandemic. Isolation and relationship stress add to the problem.

Patrick Ross, MD, a critical care physician at Children’s Hospital of Los Angeles, was plagued with increasing worry about his health and that of his family, patients, and colleagues. While distancing from his wife and daughter, he became terrified of falling ill and dying alone.

As he grew more anxious, Ross withdrew from family, colleagues, and friends, although his clinical and academic responsibilities were unaffected. He barely ate; his weight plummeted, and he began to have suicidal thoughts.

Rebecca Margolis, DO, a pediatric anesthesiologist whom Ross was mentoring, noticed something was amiss and suggested that he go to a therapist. That suggestion may have saved him.

“Once I started therapy, I no longer had suicidal ideations, but I still remained anxious on a day-to-day basis,” said Ross, who is an associate professor of clinical anesthesiology and pediatrics at the University of Southern California, Los Angeles. “As soon as I learned to manage or mitigate the anxiety, I was no longer consumed to the degree I had been by the sense of day-to-day threat.”

Ross openly shares his story because “many other physicians may be going through versions of what I experienced, and I want to encourage them to get help if they’re feeling stressed, anxious, lonely, depressed, or burned out, and to recognize that they are not alone.”
 

Physicians feel a sense of betrayal

Ross’ experience, although extreme, is not unique. According to a Medscape survey of almost 7,500 physicians, about two-thirds (64%) of U.S. physicians reported experiencing more intense burnout, and close to half (46%) reported feeling more lonely and isolated during the pandemic.

“We know that stress, which was already significant in physicians, has increased dramatically for many physicians during the pandemic. That’s understandable, given the circumstances they’ve been working under,” said Christine A. Sinsky, MD, vice president of professional satisfaction at the American Medical Association.

Physicians are stressed about potentially contracting the virus or infecting family members; being overworked and fatigued; witnessing wrenching scenes of patients dying alone; grieving the loss of patients, colleagues, or family members; and sometimes lacking adequate personal protective equipment (PPE), she said.

Lack of PPE has been identified as one of the most significant contributors to burnout and stress among physicians and other health care professionals. In all eight countries surveyed by Medscape, a significant number of respondents reported lacking appropriate PPE “sometimes,” “often,” or “always” when treating COVID-19 patients. Only 54% of U.S. respondents said they were always adequately protected.

The PPE shortage not only jeopardizes physical health but also has a negative effect on mental health and morale. A U.S.-based rheumatologist said, “The fact that we were sent to take care of infectious patients without proper PPE makes me feel we were betrayed in this fight.”
 

Not what they signed up for

Many physicians expressed fear regarding their personal safety, but that was often superseded by concern for family – especially elderly relatives or young children. (Medscape’s survey found that 9% of US respondents had immediate family members who had been diagnosed with COVID-19.)

Larissa Thomas, MD, MPH, University of California, San Francisco, said her greatest fear was bringing the virus home to her new baby and other vulnerable family members. Thomas is associate clinical professor of medicine and is a faculty hospitalist at Zuckerberg San Francisco General Hospital.

“Although physicians assume risk in our work, we didn’t sign up to care for patients without adequate protection, and our families certainly didn’t sign up for that risk, so the concern was acutely stressful,” said Thomas, who is also associate program director for the UCSF Internal Medicine Residency Program and is director of well-being for UCSF Graduate Medical Education.

The impact of stay-at-home restrictions on family members’ mental health also affected many physicians.

David Marcus, MD, residency director of the Combined Program in Emergency/Internal/Critical Care Medicine and chair of the GME Physician Wellbeing Committee at Northwell Health, Long Island, New York, said that a large stressor during the pandemic was having an elderly father with multiple comorbidities who lived alone and was unable to go out because of stay-at-home restrictions.

“I was worried not only for his physical health but also that his cognition might slip due to lack of socialization,” said Marcus.

Marcus was also worried about his preschool-age daughter, who seemed to be regressing and becoming desocialized from no longer being at school. “Fortunately, school has reopened, but it was a constant weight on my wife and me to see the impact of the lockdown on her development,” he said.
 

New situations create more anxiety

Being redeployed to new clinical roles in settings such as the emergency department or intensive care, which were not in their area of specialty, created much stress for physicians, Thomas said.

Physicians in private practice also had to adjust to new ways of practicing. In Medscape’s survey, 39% of U.S. physicians reported that their medical practice never closed during the pandemic. Keeping a practice open often meant learning to see patients virtually or becoming extremely vigilant about reducing the risk for contagion when seeing patients in person.
 

Relationships became more challenging

Social distancing during the pandemic had a negative effect on personal relationships for 44% of respondents, both in the United States and abroad.

One physician described her relationship with her partner as “more stressful” and argumentative. A rheumatologist reported experiencing frustration at having college-aged children living at home. Another respondent said that being with young children 24/7 left her “short-tempered,” and an emergency medicine physician respondent said she and her family were “driving each other crazy.”

Social distancing was not the only challenge to relationships. An orthopedist identified long, taxing work hours as contributing to a “decline in spousal harmony.”

On the other hand, some physicians said their relationships improved by developing shared insight. An emergency medicine physician wrote that he and his wife were “having more quarrels” but were “trying very hard and succeeding at understanding that much of this is due to the changes in our living situation.”

As a volunteer with New York City’s Medical Reserve Corps, Wilfrid Noel Raby, PhD, MD, adjunct clinical professor of psychiatry, Albert Einstein College of Medicine, New York City, chose to keep his Teaneck, New Jersey–based office open and was taking overnight shifts at Lincoln Hospital in New York City during the acute physician shortage. “After my regular hospital job treating psychiatric patients and seeing patients in my private practice, I sometimes pulled 12-hour nights caring for very ill patients. It was grueling, and I came home drained and exhausted,” he recalled.

Raby’s wife, a surgical nurse, had been redeployed to care for COVID-19 patients in the ICU – a situation she found grueling as well. Adding to the stress were the “rigorous distancing and sanitation precautions we needed to practice at home.” Fear of contagion, together with exhaustion, resulted in “occasional moments of friction,” Raby acknowledged.

Still, some physicians managed to find a bit of a silver lining. “We tried to relax, get as much sleep as possible, and keep things simple, not taking on extra tasks that could be postponed,” Raby said. “It helped that we both recognized how difficult it was to reassure each other when we were stressed and scared, so we faced the crisis together, and I think it ultimately brought us closer.”

Thomas said that the pandemic has helped her to recognize what she can and cannot control and how to take things one day at a time.

“When my husband and I can both work from home, we are grateful to have that ability and grateful for the things that we do have. These small moments of gratitude have sustained us day to day,” Thomas said.
 

Socializing outside the box

Several physicians expressed a sense of loneliness because stay-at-home guidelines and social distancing prevented them from socializing with friends. In all countries, physician respondents to the Medscape survey reported feeling “more lonely” than prior to the pandemic. Over half (51%) of Portuguese physicians reported feeling lonelier; 48% of physicians in Brazil felt that way. The United States came in third, at 46%.

Many physicians feel cut off, even from other physicians, and are reluctant to share feelings of distress.

“Talking to colleagues about distress is an important human connection,” Margolis emphasized. “We need to rely on each other to commiserate and receive validation and comfort.”

Some institutions have formalized this process by instituting a “battle buddy” model – a term borrowed from the military – which involves pairing clinicians of similar specialty, career stage, and life circumstances to provide mutual peer support, Margolis said. A partner who notices concerning signs in the other partner can refer the person to resources for help.

Sinsky said that an organization called PeerRxMed offers physicians a chance to sign up for a “buddy,” even outside their own institution.
 

The importance of ‘fixing’ the workplace

Close to half (43%) of U.S. respondents to Medscape’s survey reported that their workplace offers activities to help physicians deal with grief and stress, but 39% said that their workplace does not offer this type of support, and 18% were not sure whether these services were offered.

At times of crisis, organizations need to offer “stress first aid,” Sinsky said. This includes providing for basic needs, such as child care, transportation, and healthy food, and having “open, transparent, and honest communication” from leadership regarding what is known and not known about the pandemic, clinician responsibilities, and stress reduction measures.

Marcus notes that, at his institution, psychiatric residents and other members of the psychiatry department have “stepped up and crafted process groups and peer support contexts to debrief, engage, explore productive outlets for feelings, and facilitate communication.” In particular, residents have found cognitive-behavioral therapy to be useful.

Despite the difficult situation, seeking help can be challenging for some physicians. One reason, Marcus says, is that doctors tend to think of themselves as being at the giving rather than the receiving end of help – especially during a crisis. “We do what we need to do, and we often don’t see the toll it takes on us,” he noted. Moreover, the pressure to be at the “giving” end can lead to stigma in acknowledging vulnerability.

Ross said he hopes his story will help to destigmatize reaching out for help. “It is possible that a silver lining of this terrible crisis is to normalize physicians receiving help for mental health issues.”

Marcus likewise openly shares his own experiences about struggles with burnout and depressive symptoms. “As a physician educator, I think it’s important for me to be public about these things, which validates help-seeking for residents and colleagues.”

For physicians seeking help not offered in their workplace, the Physician Support Line is a useful resource, added Margolis. She noted that its services are free and confidential.

This article first appeared on Medscape.com.

A recent Medscape survey found there were high levels of loneliness, stress, and burnout in physicians during the COVID-19 pandemic. Isolation and relationship stress add to the problem.

Patrick Ross, MD, a critical care physician at Children’s Hospital of Los Angeles, was plagued with increasing worry about his health and that of his family, patients, and colleagues. While distancing from his wife and daughter, he became terrified of falling ill and dying alone.

As he grew more anxious, Ross withdrew from family, colleagues, and friends, although his clinical and academic responsibilities were unaffected. He barely ate; his weight plummeted, and he began to have suicidal thoughts.

Rebecca Margolis, DO, a pediatric anesthesiologist whom Ross was mentoring, noticed something was amiss and suggested that he go to a therapist. That suggestion may have saved him.

“Once I started therapy, I no longer had suicidal ideations, but I still remained anxious on a day-to-day basis,” said Ross, who is an associate professor of clinical anesthesiology and pediatrics at the University of Southern California, Los Angeles. “As soon as I learned to manage or mitigate the anxiety, I was no longer consumed to the degree I had been by the sense of day-to-day threat.”

Ross openly shares his story because “many other physicians may be going through versions of what I experienced, and I want to encourage them to get help if they’re feeling stressed, anxious, lonely, depressed, or burned out, and to recognize that they are not alone.”
 

Physicians feel a sense of betrayal

Ross’ experience, although extreme, is not unique. According to a Medscape survey of almost 7,500 physicians, about two-thirds (64%) of U.S. physicians reported experiencing more intense burnout, and close to half (46%) reported feeling more lonely and isolated during the pandemic.

“We know that stress, which was already significant in physicians, has increased dramatically for many physicians during the pandemic. That’s understandable, given the circumstances they’ve been working under,” said Christine A. Sinsky, MD, vice president of professional satisfaction at the American Medical Association.

Physicians are stressed about potentially contracting the virus or infecting family members; being overworked and fatigued; witnessing wrenching scenes of patients dying alone; grieving the loss of patients, colleagues, or family members; and sometimes lacking adequate personal protective equipment (PPE), she said.

Lack of PPE has been identified as one of the most significant contributors to burnout and stress among physicians and other health care professionals. In all eight countries surveyed by Medscape, a significant number of respondents reported lacking appropriate PPE “sometimes,” “often,” or “always” when treating COVID-19 patients. Only 54% of U.S. respondents said they were always adequately protected.

The PPE shortage not only jeopardizes physical health but also has a negative effect on mental health and morale. A U.S.-based rheumatologist said, “The fact that we were sent to take care of infectious patients without proper PPE makes me feel we were betrayed in this fight.”
 

Not what they signed up for

Many physicians expressed fear regarding their personal safety, but that was often superseded by concern for family – especially elderly relatives or young children. (Medscape’s survey found that 9% of US respondents had immediate family members who had been diagnosed with COVID-19.)

Larissa Thomas, MD, MPH, University of California, San Francisco, said her greatest fear was bringing the virus home to her new baby and other vulnerable family members. Thomas is associate clinical professor of medicine and is a faculty hospitalist at Zuckerberg San Francisco General Hospital.

“Although physicians assume risk in our work, we didn’t sign up to care for patients without adequate protection, and our families certainly didn’t sign up for that risk, so the concern was acutely stressful,” said Thomas, who is also associate program director for the UCSF Internal Medicine Residency Program and is director of well-being for UCSF Graduate Medical Education.

The impact of stay-at-home restrictions on family members’ mental health also affected many physicians.

David Marcus, MD, residency director of the Combined Program in Emergency/Internal/Critical Care Medicine and chair of the GME Physician Wellbeing Committee at Northwell Health, Long Island, New York, said that a large stressor during the pandemic was having an elderly father with multiple comorbidities who lived alone and was unable to go out because of stay-at-home restrictions.

“I was worried not only for his physical health but also that his cognition might slip due to lack of socialization,” said Marcus.

Marcus was also worried about his preschool-age daughter, who seemed to be regressing and becoming desocialized from no longer being at school. “Fortunately, school has reopened, but it was a constant weight on my wife and me to see the impact of the lockdown on her development,” he said.
 

New situations create more anxiety

Being redeployed to new clinical roles in settings such as the emergency department or intensive care, which were not in their area of specialty, created much stress for physicians, Thomas said.

Physicians in private practice also had to adjust to new ways of practicing. In Medscape’s survey, 39% of U.S. physicians reported that their medical practice never closed during the pandemic. Keeping a practice open often meant learning to see patients virtually or becoming extremely vigilant about reducing the risk for contagion when seeing patients in person.
 

Relationships became more challenging

Social distancing during the pandemic had a negative effect on personal relationships for 44% of respondents, both in the United States and abroad.

One physician described her relationship with her partner as “more stressful” and argumentative. A rheumatologist reported experiencing frustration at having college-aged children living at home. Another respondent said that being with young children 24/7 left her “short-tempered,” and an emergency medicine physician respondent said she and her family were “driving each other crazy.”

Social distancing was not the only challenge to relationships. An orthopedist identified long, taxing work hours as contributing to a “decline in spousal harmony.”

On the other hand, some physicians said their relationships improved by developing shared insight. An emergency medicine physician wrote that he and his wife were “having more quarrels” but were “trying very hard and succeeding at understanding that much of this is due to the changes in our living situation.”

As a volunteer with New York City’s Medical Reserve Corps, Wilfrid Noel Raby, PhD, MD, adjunct clinical professor of psychiatry, Albert Einstein College of Medicine, New York City, chose to keep his Teaneck, New Jersey–based office open and was taking overnight shifts at Lincoln Hospital in New York City during the acute physician shortage. “After my regular hospital job treating psychiatric patients and seeing patients in my private practice, I sometimes pulled 12-hour nights caring for very ill patients. It was grueling, and I came home drained and exhausted,” he recalled.

Raby’s wife, a surgical nurse, had been redeployed to care for COVID-19 patients in the ICU – a situation she found grueling as well. Adding to the stress were the “rigorous distancing and sanitation precautions we needed to practice at home.” Fear of contagion, together with exhaustion, resulted in “occasional moments of friction,” Raby acknowledged.

Still, some physicians managed to find a bit of a silver lining. “We tried to relax, get as much sleep as possible, and keep things simple, not taking on extra tasks that could be postponed,” Raby said. “It helped that we both recognized how difficult it was to reassure each other when we were stressed and scared, so we faced the crisis together, and I think it ultimately brought us closer.”

Thomas said that the pandemic has helped her to recognize what she can and cannot control and how to take things one day at a time.

“When my husband and I can both work from home, we are grateful to have that ability and grateful for the things that we do have. These small moments of gratitude have sustained us day to day,” Thomas said.
 

Socializing outside the box

Several physicians expressed a sense of loneliness because stay-at-home guidelines and social distancing prevented them from socializing with friends. In all countries, physician respondents to the Medscape survey reported feeling “more lonely” than prior to the pandemic. Over half (51%) of Portuguese physicians reported feeling lonelier; 48% of physicians in Brazil felt that way. The United States came in third, at 46%.

Many physicians feel cut off, even from other physicians, and are reluctant to share feelings of distress.

“Talking to colleagues about distress is an important human connection,” Margolis emphasized. “We need to rely on each other to commiserate and receive validation and comfort.”

Some institutions have formalized this process by instituting a “battle buddy” model – a term borrowed from the military – which involves pairing clinicians of similar specialty, career stage, and life circumstances to provide mutual peer support, Margolis said. A partner who notices concerning signs in the other partner can refer the person to resources for help.

Sinsky said that an organization called PeerRxMed offers physicians a chance to sign up for a “buddy,” even outside their own institution.
 

The importance of ‘fixing’ the workplace

Close to half (43%) of U.S. respondents to Medscape’s survey reported that their workplace offers activities to help physicians deal with grief and stress, but 39% said that their workplace does not offer this type of support, and 18% were not sure whether these services were offered.

At times of crisis, organizations need to offer “stress first aid,” Sinsky said. This includes providing for basic needs, such as child care, transportation, and healthy food, and having “open, transparent, and honest communication” from leadership regarding what is known and not known about the pandemic, clinician responsibilities, and stress reduction measures.

Marcus notes that, at his institution, psychiatric residents and other members of the psychiatry department have “stepped up and crafted process groups and peer support contexts to debrief, engage, explore productive outlets for feelings, and facilitate communication.” In particular, residents have found cognitive-behavioral therapy to be useful.

Despite the difficult situation, seeking help can be challenging for some physicians. One reason, Marcus says, is that doctors tend to think of themselves as being at the giving rather than the receiving end of help – especially during a crisis. “We do what we need to do, and we often don’t see the toll it takes on us,” he noted. Moreover, the pressure to be at the “giving” end can lead to stigma in acknowledging vulnerability.

Ross said he hopes his story will help to destigmatize reaching out for help. “It is possible that a silver lining of this terrible crisis is to normalize physicians receiving help for mental health issues.”

Marcus likewise openly shares his own experiences about struggles with burnout and depressive symptoms. “As a physician educator, I think it’s important for me to be public about these things, which validates help-seeking for residents and colleagues.”

For physicians seeking help not offered in their workplace, the Physician Support Line is a useful resource, added Margolis. She noted that its services are free and confidential.

This article first appeared on Medscape.com.

Percutaneous mitral valve repair with the MitraClip appears to be a safe, effective, and life-saving new treatment for severe acute mitral regurgitation (MR) secondary to MI in surgical noncandidates, even when accompanied by cardiogenic shock, according to data from the international IREMMI registry.

“Cardiogenic shock, when adequately supported, does not seem to influence short- and mid-term outcomes, so the development of cardiogenic shock should not preclude percutaneous mitral valve repair in this scenario,” Rodrigo Estevez-Loureiro, MD, PhD, said in presenting the IREMMI (International Registry of MitraClip in Acute Myocardial Infarction) findings reported at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.

Commentators hailed the prospective IREMMI data as potentially practice changing in light of the dire prognosis of such patients when surgery is deemed unacceptably high risk because medical management, the traditionally the only alternative, has a 30-day mortality of up to 50%.

Severe acute MR occurs in an estimated 3% of acute MIs, and in roughly 10% of patients who present with acute MI complicated by cardiogenic shock (CS). The impact of intervening with the MitraClip in an effort to correct the acute MR arising from MI with CS has previously been addressed only in sparse case reports. The new IREMMI study is easily the largest dataset to date detailing clinical and echocardiographic outcomes, Dr. Estevez-Loureiro of Alvaro Cunqueiro Hospital in Vigo, Spain, said at the meeting, sponsored by the Cardiovascular Research Foundation.

He reported on 93 consecutive patients who underwent MitraClip implantation for acute MR arising in the setting of MI, including 50 patients in CS at the time of the procedure. All 93 patients had been turned down by their surgical team because of extreme surgical risk. Three-quarters of the MIs showed ST-segment elevation. Only six patients had a papillary muscle rupture; in the rest, the mechanism of acute MR involved left ventricular global remodeling associated with mitral valve leaflet tethering. Percutaneous valve repair was performed at 18 expert valvular heart centers in the United States, Canada, Israel, and five European countries.
 

Procedural success

Time from MI to MitraClip implantation averaged 24 days in the CS patients and 33 days in the comparator arm without CS.

“These patients had been turned down for surgery, so the attending physicians generally followed a strategy of trying to cool them down with mechanical circulatory support and vasopressors. MitraClip wasn’t an option at the beginning, but after two or three failed weanings from all the possible therapies, then MitraClip becomes an option. This is one of the reasons why the time lapse between MI and the clip is so large,” the cardiologist explained.

Procedural success rates were similar in the two groups: 90% in those with CS and 93% in those without. However, average procedure time was significantly longer in the CS patients: 143 minutes versus 83 minutes in the patients without CS.

At baseline, 86% of the CS group had grade 4+ MR, similar to the 79% rate in the non-CS patients. Postprocedurally, 60% of the CS group were MR grade 0/1 and 34% were grade 2, comparable to the rates of 65% and 23% in the non-CS group.

At 3 months’ follow-up, 83.4% of the CS group had MR grade 2 or less, again not significantly different from the 90.5% rate in non-CS patients. Systolic pulmonary artery pressure was also similar: 39.6 mm Hg in the CS patients, 44 mm Hg in those without. While everyone was New York Heart Association functional class IV preprocedurally, 79.5% of the CS group were NYHA class I or II at 3 months, not significantly different from the 86.5% prevalence in the comparator arm.
 

Longer-term clinical outcomes

At a median follow-up of 7 months, the composite primary clinical outcome composed of all-cause mortality or heart failure rehospitalization did not differ between the two groups: a 28% rate in the CS group and 25.6% in non-CS patients. All-cause mortality occurred in 16% with CS and 9.3% without, again not a significant difference.

In a Cox regression analysis, neither surgical risk score, patient age, left ventricular geometry, nor CS was independently associated with the primary composite endpoint. Indeed, the only independent predictor of freedom from mortality or heart failure readmission at follow-up was procedural success, which is very much a function of the experience of the heart team, Dr. Estevez-Loureiro continued.

Michael A. Borger, MD, PhD, who comoderated the late-breaking clinical science session, was wowed by the IREMMI results.

“The mortality rates, I can tell you, compared to traditional surgical series of acute MR in the face of ACS [acute cardiogenic shock] are very, very respectable,” commented Dr. Borger, director of the cardiac surgery clinic at the Leipzig (Ger.) University Heart Center.

“Extremely impressive,” agreed discussant Vinayak N. Bapat, MD, a cardiothoracic surgeon and valve scientist at the Minneapolis Heart Institute Foundation. He posed a practical question: “Should we take from this presentation that patients should be stabilized with something like ECMO [extracorporeal membrane oxygenation] or Impella [left ventricular assist device], then transferred to an expert center for the procedure?”

“I think that the stabilization is essential in the patients with cardiogenic shock,” Dr. Estevez-Loureiro replied. “Unlike with surgery, it’s very difficult to establish a MitraClip procedure in a couple of hours in the middle of the night. You have to stabilize them and then treat for shock with ECMO, Impella, or both. I think they should be transferred to a center than can deliver the best treatment. In centers with less experience, patients can be put on mechanical support and transferred to an expert valve center, not only for MitraClip implantation, but for discussion of all the treatment possibilities, including surgery.”

At a press conference in which Dr. Estevez-Loureiro presented highlights of the IREMMI study, discussant Dee Dee Wang, MD, said the international coinvestigators “need to be applauded” for this study.

“Having these outcomes is incredible,” declared Dr. Wang, a structural heart disease specialist at the Henry Ford Health System, Detroit.

While this is an observational study, it’s a high-quality dataset with excellent methodology. And conducting a randomized trial in patients with such high surgical risk scores – the CS group had an average EuroSCORE II of 21 – would be extremely difficult, according to the cardiologist.

Dr. Estevez-Loureiro reported receiving research grants from Abbott and serving as a consultant to that company as well as Boston Scientific.
 

[email protected]

SOURCE: Estevez-Loureiro, R. TCT 2020, LBCS session IV.

Percutaneous mitral valve repair with the MitraClip appears to be a safe, effective, and life-saving new treatment for severe acute mitral regurgitation (MR) secondary to MI in surgical noncandidates, even when accompanied by cardiogenic shock, according to data from the international IREMMI registry.

“Cardiogenic shock, when adequately supported, does not seem to influence short- and mid-term outcomes, so the development of cardiogenic shock should not preclude percutaneous mitral valve repair in this scenario,” Rodrigo Estevez-Loureiro, MD, PhD, said in presenting the IREMMI (International Registry of MitraClip in Acute Myocardial Infarction) findings reported at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.

Commentators hailed the prospective IREMMI data as potentially practice changing in light of the dire prognosis of such patients when surgery is deemed unacceptably high risk because medical management, the traditionally the only alternative, has a 30-day mortality of up to 50%.

Severe acute MR occurs in an estimated 3% of acute MIs, and in roughly 10% of patients who present with acute MI complicated by cardiogenic shock (CS). The impact of intervening with the MitraClip in an effort to correct the acute MR arising from MI with CS has previously been addressed only in sparse case reports. The new IREMMI study is easily the largest dataset to date detailing clinical and echocardiographic outcomes, Dr. Estevez-Loureiro of Alvaro Cunqueiro Hospital in Vigo, Spain, said at the meeting, sponsored by the Cardiovascular Research Foundation.

He reported on 93 consecutive patients who underwent MitraClip implantation for acute MR arising in the setting of MI, including 50 patients in CS at the time of the procedure. All 93 patients had been turned down by their surgical team because of extreme surgical risk. Three-quarters of the MIs showed ST-segment elevation. Only six patients had a papillary muscle rupture; in the rest, the mechanism of acute MR involved left ventricular global remodeling associated with mitral valve leaflet tethering. Percutaneous valve repair was performed at 18 expert valvular heart centers in the United States, Canada, Israel, and five European countries.
 

Procedural success

Time from MI to MitraClip implantation averaged 24 days in the CS patients and 33 days in the comparator arm without CS.

“These patients had been turned down for surgery, so the attending physicians generally followed a strategy of trying to cool them down with mechanical circulatory support and vasopressors. MitraClip wasn’t an option at the beginning, but after two or three failed weanings from all the possible therapies, then MitraClip becomes an option. This is one of the reasons why the time lapse between MI and the clip is so large,” the cardiologist explained.

Procedural success rates were similar in the two groups: 90% in those with CS and 93% in those without. However, average procedure time was significantly longer in the CS patients: 143 minutes versus 83 minutes in the patients without CS.

At baseline, 86% of the CS group had grade 4+ MR, similar to the 79% rate in the non-CS patients. Postprocedurally, 60% of the CS group were MR grade 0/1 and 34% were grade 2, comparable to the rates of 65% and 23% in the non-CS group.

At 3 months’ follow-up, 83.4% of the CS group had MR grade 2 or less, again not significantly different from the 90.5% rate in non-CS patients. Systolic pulmonary artery pressure was also similar: 39.6 mm Hg in the CS patients, 44 mm Hg in those without. While everyone was New York Heart Association functional class IV preprocedurally, 79.5% of the CS group were NYHA class I or II at 3 months, not significantly different from the 86.5% prevalence in the comparator arm.
 

Longer-term clinical outcomes

At a median follow-up of 7 months, the composite primary clinical outcome composed of all-cause mortality or heart failure rehospitalization did not differ between the two groups: a 28% rate in the CS group and 25.6% in non-CS patients. All-cause mortality occurred in 16% with CS and 9.3% without, again not a significant difference.

In a Cox regression analysis, neither surgical risk score, patient age, left ventricular geometry, nor CS was independently associated with the primary composite endpoint. Indeed, the only independent predictor of freedom from mortality or heart failure readmission at follow-up was procedural success, which is very much a function of the experience of the heart team, Dr. Estevez-Loureiro continued.

Michael A. Borger, MD, PhD, who comoderated the late-breaking clinical science session, was wowed by the IREMMI results.

“The mortality rates, I can tell you, compared to traditional surgical series of acute MR in the face of ACS [acute cardiogenic shock] are very, very respectable,” commented Dr. Borger, director of the cardiac surgery clinic at the Leipzig (Ger.) University Heart Center.

“Extremely impressive,” agreed discussant Vinayak N. Bapat, MD, a cardiothoracic surgeon and valve scientist at the Minneapolis Heart Institute Foundation. He posed a practical question: “Should we take from this presentation that patients should be stabilized with something like ECMO [extracorporeal membrane oxygenation] or Impella [left ventricular assist device], then transferred to an expert center for the procedure?”

“I think that the stabilization is essential in the patients with cardiogenic shock,” Dr. Estevez-Loureiro replied. “Unlike with surgery, it’s very difficult to establish a MitraClip procedure in a couple of hours in the middle of the night. You have to stabilize them and then treat for shock with ECMO, Impella, or both. I think they should be transferred to a center than can deliver the best treatment. In centers with less experience, patients can be put on mechanical support and transferred to an expert valve center, not only for MitraClip implantation, but for discussion of all the treatment possibilities, including surgery.”

At a press conference in which Dr. Estevez-Loureiro presented highlights of the IREMMI study, discussant Dee Dee Wang, MD, said the international coinvestigators “need to be applauded” for this study.

“Having these outcomes is incredible,” declared Dr. Wang, a structural heart disease specialist at the Henry Ford Health System, Detroit.

While this is an observational study, it’s a high-quality dataset with excellent methodology. And conducting a randomized trial in patients with such high surgical risk scores – the CS group had an average EuroSCORE II of 21 – would be extremely difficult, according to the cardiologist.

Dr. Estevez-Loureiro reported receiving research grants from Abbott and serving as a consultant to that company as well as Boston Scientific.
 

[email protected]

SOURCE: Estevez-Loureiro, R. TCT 2020, LBCS session IV.

Percutaneous mitral valve repair with the MitraClip appears to be a safe, effective, and life-saving new treatment for severe acute mitral regurgitation (MR) secondary to MI in surgical noncandidates, even when accompanied by cardiogenic shock, according to data from the international IREMMI registry.

“Cardiogenic shock, when adequately supported, does not seem to influence short- and mid-term outcomes, so the development of cardiogenic shock should not preclude percutaneous mitral valve repair in this scenario,” Rodrigo Estevez-Loureiro, MD, PhD, said in presenting the IREMMI (International Registry of MitraClip in Acute Myocardial Infarction) findings reported at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.

Commentators hailed the prospective IREMMI data as potentially practice changing in light of the dire prognosis of such patients when surgery is deemed unacceptably high risk because medical management, the traditionally the only alternative, has a 30-day mortality of up to 50%.

Severe acute MR occurs in an estimated 3% of acute MIs, and in roughly 10% of patients who present with acute MI complicated by cardiogenic shock (CS). The impact of intervening with the MitraClip in an effort to correct the acute MR arising from MI with CS has previously been addressed only in sparse case reports. The new IREMMI study is easily the largest dataset to date detailing clinical and echocardiographic outcomes, Dr. Estevez-Loureiro of Alvaro Cunqueiro Hospital in Vigo, Spain, said at the meeting, sponsored by the Cardiovascular Research Foundation.

He reported on 93 consecutive patients who underwent MitraClip implantation for acute MR arising in the setting of MI, including 50 patients in CS at the time of the procedure. All 93 patients had been turned down by their surgical team because of extreme surgical risk. Three-quarters of the MIs showed ST-segment elevation. Only six patients had a papillary muscle rupture; in the rest, the mechanism of acute MR involved left ventricular global remodeling associated with mitral valve leaflet tethering. Percutaneous valve repair was performed at 18 expert valvular heart centers in the United States, Canada, Israel, and five European countries.
 

Procedural success

Time from MI to MitraClip implantation averaged 24 days in the CS patients and 33 days in the comparator arm without CS.

“These patients had been turned down for surgery, so the attending physicians generally followed a strategy of trying to cool them down with mechanical circulatory support and vasopressors. MitraClip wasn’t an option at the beginning, but after two or three failed weanings from all the possible therapies, then MitraClip becomes an option. This is one of the reasons why the time lapse between MI and the clip is so large,” the cardiologist explained.

Procedural success rates were similar in the two groups: 90% in those with CS and 93% in those without. However, average procedure time was significantly longer in the CS patients: 143 minutes versus 83 minutes in the patients without CS.

At baseline, 86% of the CS group had grade 4+ MR, similar to the 79% rate in the non-CS patients. Postprocedurally, 60% of the CS group were MR grade 0/1 and 34% were grade 2, comparable to the rates of 65% and 23% in the non-CS group.

At 3 months’ follow-up, 83.4% of the CS group had MR grade 2 or less, again not significantly different from the 90.5% rate in non-CS patients. Systolic pulmonary artery pressure was also similar: 39.6 mm Hg in the CS patients, 44 mm Hg in those without. While everyone was New York Heart Association functional class IV preprocedurally, 79.5% of the CS group were NYHA class I or II at 3 months, not significantly different from the 86.5% prevalence in the comparator arm.
 

Longer-term clinical outcomes

At a median follow-up of 7 months, the composite primary clinical outcome composed of all-cause mortality or heart failure rehospitalization did not differ between the two groups: a 28% rate in the CS group and 25.6% in non-CS patients. All-cause mortality occurred in 16% with CS and 9.3% without, again not a significant difference.

In a Cox regression analysis, neither surgical risk score, patient age, left ventricular geometry, nor CS was independently associated with the primary composite endpoint. Indeed, the only independent predictor of freedom from mortality or heart failure readmission at follow-up was procedural success, which is very much a function of the experience of the heart team, Dr. Estevez-Loureiro continued.

Michael A. Borger, MD, PhD, who comoderated the late-breaking clinical science session, was wowed by the IREMMI results.

“The mortality rates, I can tell you, compared to traditional surgical series of acute MR in the face of ACS [acute cardiogenic shock] are very, very respectable,” commented Dr. Borger, director of the cardiac surgery clinic at the Leipzig (Ger.) University Heart Center.

“Extremely impressive,” agreed discussant Vinayak N. Bapat, MD, a cardiothoracic surgeon and valve scientist at the Minneapolis Heart Institute Foundation. He posed a practical question: “Should we take from this presentation that patients should be stabilized with something like ECMO [extracorporeal membrane oxygenation] or Impella [left ventricular assist device], then transferred to an expert center for the procedure?”

“I think that the stabilization is essential in the patients with cardiogenic shock,” Dr. Estevez-Loureiro replied. “Unlike with surgery, it’s very difficult to establish a MitraClip procedure in a couple of hours in the middle of the night. You have to stabilize them and then treat for shock with ECMO, Impella, or both. I think they should be transferred to a center than can deliver the best treatment. In centers with less experience, patients can be put on mechanical support and transferred to an expert valve center, not only for MitraClip implantation, but for discussion of all the treatment possibilities, including surgery.”

At a press conference in which Dr. Estevez-Loureiro presented highlights of the IREMMI study, discussant Dee Dee Wang, MD, said the international coinvestigators “need to be applauded” for this study.

“Having these outcomes is incredible,” declared Dr. Wang, a structural heart disease specialist at the Henry Ford Health System, Detroit.

While this is an observational study, it’s a high-quality dataset with excellent methodology. And conducting a randomized trial in patients with such high surgical risk scores – the CS group had an average EuroSCORE II of 21 – would be extremely difficult, according to the cardiologist.

Dr. Estevez-Loureiro reported receiving research grants from Abbott and serving as a consultant to that company as well as Boston Scientific.
 

[email protected]

SOURCE: Estevez-Loureiro, R. TCT 2020, LBCS session IV.

Intravascular lithotripsy proved highly effective, safe, and user friendly as an adjunct to stenting for severely calcified coronary lesions at 30 days of follow-up in the pivotal Disrupt CAD III study aimed at gaining U.S. regulatory approval.

The technology is basically the same as in extracorporeal lithotripsy, used for the treatment of kidney stones for more than 30 years: namely, transmission of pulsed acoustic pressure waves in order to fracture calcium. For interventional cardiology purposes, however, the transmitter is located within a balloon angioplasty catheter, Dean J. Kereiakes, MD, explained in presenting the study results at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.

In Disrupt CAD III, intravascular lithotripsy far exceeded the procedural success and 30-day freedom from major adverse cardiovascular event (MACE) performance targets set in conjunction with the Food and Drug Administration. In so doing, the intravascular lithotripsy device developed by Shockwave Medical successfully addressed one of the banes of contemporary interventional cardiology: heavily calcified coronary lesions.

Currently available technologies targeting such lesions, including noncompliant high-pressure balloons, intravascular lasers, cutting balloons, and orbital and rotational atherectomy, often yield suboptimal results, noted Dr. Kereiakes, medical director of the Christ Hospital Heart and Cardiovascular Center in Cincinnati.

Severe vascular calcifications are becoming more common, due in part to an aging population and the growing prevalence of hypertension, diabetes, and renal insufficiency. Severely calcified coronary lesions complicate percutaneous coronary intervention. They’re associated with increased risks of dissection, perforation, and periprocedural MI. Moreover, heavily calcified lesions impede stent delivery and expansion – and stent underexpansion is the leading predictor of restenosis and stent thrombosis, he observed at the meeting, sponsored by the Cardiovascular Research Foundation. Disrupt CAD III was a prospective single-arm study of 384 patients at 47 sites in the United States and several European countries. All participants had de novo coronary calcifications graded as severe by core laboratory assessment, with a mean calcified length of 47.9 mm by quantitative coronary angiography and a mean calcium angle and thickness of 292.5 degrees and 0.96 mm by optical coherence tomography.

“It’s staggering, the level of calcification these patients had. It’s jaw dropping,” Dr. Kereiakes observed.

Intravascular lithotripsy was used to prepare these severely calcified lesions for stenting. The intervention entailed transmission of acoustic waves circumferentially and transmurally at 1 pulse per second through tissue at an effective pressure of about 50 atm. Patients received an average of 69 pulses.

This was not a randomized trial; there was no sham-treated control arm. Instead, the comparator group selected under regulatory guidance was comprised of patients who had received orbital atherectomy for severe coronary calcifications in the earlier, similarly designed ORBIT II trial, which led to FDA marketing approval of that technology.

Key outcomes

The procedural success rate, defined as successful stent delivery with less than a 50% residual stenosis and no in-hospital MACE, was 92.4% in Disrupt CAD III, compared to 83.4% for orbital atherectomy in ORBIT II. The primary safety endpoint of freedom from cardiac death, MI, or target vessel revascularization at 30 days was achieved in 92.2% of patients in the intravascular lithotripsy trial, versus 84.4% in ORBIT II.

The 30-day MACE rate of 7.8% in Disrupt CAD III was primarily driven by periprocedural MIs, which occurred in 6.8% of participants. Only one-third of the MIs were clinically relevant by the Society for Coronary Angiography and Intervention definition. There were two cardiac deaths and three cases of stent thrombosis, all of which were associated with known predictors of the complication. There was 1 case each of dissection, abrupt closure, and perforation, but no instances of slow flow or no reflow at the procedure’s end. Transient lithotripsy-induced left ventricular capture occurred in 41% of patients, but they were benign events with no lasting consequences.

The device was able to cross and deliver acoustic pressure wave therapy to 98.2% of lesions. The mean diameter stenosis preprocedure was 65.1%, dropping to 37.2% post lithotripsy, with a final in-stent residual stenosis diameter of 11.9%, with a 1.7-mm acute gain. The average stent expansion at the site of maximum calcification was 102%, with a minimum stent area of 6.5 mm².

Optical coherence imaging revealed that 67% of treated lesions had circumferential and transmural fractures of both deep and superficial calcium post lithotripsy. Yet outcomes were the same regardless of whether fractures were evident on imaging.

At 30-day follow-up, 72.9% of patients had no angina, up from just 12.6% of participants pre-PCI. Follow-up will continue for 2 years.

Outcomes were similar for the first case done at each participating center and all cases thereafter.

“The ease of use was remarkable,” Dr. Kereiakes recalled. “The learning curve is virtually nonexistent.”
 

The reaction

At a press conference where Dr. Kereiakes presented the Disrupt CAD III results, discussant Allen Jeremias, MD, said he found the results compelling.

“The success rate is high, I think it’s relatively easy to use, as demonstrated, and I think the results are spectacular,” said Dr. Jeremias, director of interventional cardiology research and associate director of the cardiac catheterization laboratory at St. Francis Hospital in Roslyn, N.Y.

Bruce Jancin/MDedge News

[email protected]

SOURCE: Kereiakes DJ. TCT 2020. Late Breaking Clinical Science session 2.

Intravascular lithotripsy proved highly effective, safe, and user friendly as an adjunct to stenting for severely calcified coronary lesions at 30 days of follow-up in the pivotal Disrupt CAD III study aimed at gaining U.S. regulatory approval.

The technology is basically the same as in extracorporeal lithotripsy, used for the treatment of kidney stones for more than 30 years: namely, transmission of pulsed acoustic pressure waves in order to fracture calcium. For interventional cardiology purposes, however, the transmitter is located within a balloon angioplasty catheter, Dean J. Kereiakes, MD, explained in presenting the study results at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.

In Disrupt CAD III, intravascular lithotripsy far exceeded the procedural success and 30-day freedom from major adverse cardiovascular event (MACE) performance targets set in conjunction with the Food and Drug Administration. In so doing, the intravascular lithotripsy device developed by Shockwave Medical successfully addressed one of the banes of contemporary interventional cardiology: heavily calcified coronary lesions.

Currently available technologies targeting such lesions, including noncompliant high-pressure balloons, intravascular lasers, cutting balloons, and orbital and rotational atherectomy, often yield suboptimal results, noted Dr. Kereiakes, medical director of the Christ Hospital Heart and Cardiovascular Center in Cincinnati.

Severe vascular calcifications are becoming more common, due in part to an aging population and the growing prevalence of hypertension, diabetes, and renal insufficiency. Severely calcified coronary lesions complicate percutaneous coronary intervention. They’re associated with increased risks of dissection, perforation, and periprocedural MI. Moreover, heavily calcified lesions impede stent delivery and expansion – and stent underexpansion is the leading predictor of restenosis and stent thrombosis, he observed at the meeting, sponsored by the Cardiovascular Research Foundation. Disrupt CAD III was a prospective single-arm study of 384 patients at 47 sites in the United States and several European countries. All participants had de novo coronary calcifications graded as severe by core laboratory assessment, with a mean calcified length of 47.9 mm by quantitative coronary angiography and a mean calcium angle and thickness of 292.5 degrees and 0.96 mm by optical coherence tomography.

“It’s staggering, the level of calcification these patients had. It’s jaw dropping,” Dr. Kereiakes observed.

Intravascular lithotripsy was used to prepare these severely calcified lesions for stenting. The intervention entailed transmission of acoustic waves circumferentially and transmurally at 1 pulse per second through tissue at an effective pressure of about 50 atm. Patients received an average of 69 pulses.

This was not a randomized trial; there was no sham-treated control arm. Instead, the comparator group selected under regulatory guidance was comprised of patients who had received orbital atherectomy for severe coronary calcifications in the earlier, similarly designed ORBIT II trial, which led to FDA marketing approval of that technology.

Key outcomes

The procedural success rate, defined as successful stent delivery with less than a 50% residual stenosis and no in-hospital MACE, was 92.4% in Disrupt CAD III, compared to 83.4% for orbital atherectomy in ORBIT II. The primary safety endpoint of freedom from cardiac death, MI, or target vessel revascularization at 30 days was achieved in 92.2% of patients in the intravascular lithotripsy trial, versus 84.4% in ORBIT II.

The 30-day MACE rate of 7.8% in Disrupt CAD III was primarily driven by periprocedural MIs, which occurred in 6.8% of participants. Only one-third of the MIs were clinically relevant by the Society for Coronary Angiography and Intervention definition. There were two cardiac deaths and three cases of stent thrombosis, all of which were associated with known predictors of the complication. There was 1 case each of dissection, abrupt closure, and perforation, but no instances of slow flow or no reflow at the procedure’s end. Transient lithotripsy-induced left ventricular capture occurred in 41% of patients, but they were benign events with no lasting consequences.

The device was able to cross and deliver acoustic pressure wave therapy to 98.2% of lesions. The mean diameter stenosis preprocedure was 65.1%, dropping to 37.2% post lithotripsy, with a final in-stent residual stenosis diameter of 11.9%, with a 1.7-mm acute gain. The average stent expansion at the site of maximum calcification was 102%, with a minimum stent area of 6.5 mm².

Optical coherence imaging revealed that 67% of treated lesions had circumferential and transmural fractures of both deep and superficial calcium post lithotripsy. Yet outcomes were the same regardless of whether fractures were evident on imaging.

At 30-day follow-up, 72.9% of patients had no angina, up from just 12.6% of participants pre-PCI. Follow-up will continue for 2 years.

Outcomes were similar for the first case done at each participating center and all cases thereafter.

“The ease of use was remarkable,” Dr. Kereiakes recalled. “The learning curve is virtually nonexistent.”
 

The reaction

At a press conference where Dr. Kereiakes presented the Disrupt CAD III results, discussant Allen Jeremias, MD, said he found the results compelling.

“The success rate is high, I think it’s relatively easy to use, as demonstrated, and I think the results are spectacular,” said Dr. Jeremias, director of interventional cardiology research and associate director of the cardiac catheterization laboratory at St. Francis Hospital in Roslyn, N.Y.

Bruce Jancin/MDedge News

[email protected]

SOURCE: Kereiakes DJ. TCT 2020. Late Breaking Clinical Science session 2.

Intravascular lithotripsy proved highly effective, safe, and user friendly as an adjunct to stenting for severely calcified coronary lesions at 30 days of follow-up in the pivotal Disrupt CAD III study aimed at gaining U.S. regulatory approval.

The technology is basically the same as in extracorporeal lithotripsy, used for the treatment of kidney stones for more than 30 years: namely, transmission of pulsed acoustic pressure waves in order to fracture calcium. For interventional cardiology purposes, however, the transmitter is located within a balloon angioplasty catheter, Dean J. Kereiakes, MD, explained in presenting the study results at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.

In Disrupt CAD III, intravascular lithotripsy far exceeded the procedural success and 30-day freedom from major adverse cardiovascular event (MACE) performance targets set in conjunction with the Food and Drug Administration. In so doing, the intravascular lithotripsy device developed by Shockwave Medical successfully addressed one of the banes of contemporary interventional cardiology: heavily calcified coronary lesions.

Currently available technologies targeting such lesions, including noncompliant high-pressure balloons, intravascular lasers, cutting balloons, and orbital and rotational atherectomy, often yield suboptimal results, noted Dr. Kereiakes, medical director of the Christ Hospital Heart and Cardiovascular Center in Cincinnati.

Severe vascular calcifications are becoming more common, due in part to an aging population and the growing prevalence of hypertension, diabetes, and renal insufficiency. Severely calcified coronary lesions complicate percutaneous coronary intervention. They’re associated with increased risks of dissection, perforation, and periprocedural MI. Moreover, heavily calcified lesions impede stent delivery and expansion – and stent underexpansion is the leading predictor of restenosis and stent thrombosis, he observed at the meeting, sponsored by the Cardiovascular Research Foundation. Disrupt CAD III was a prospective single-arm study of 384 patients at 47 sites in the United States and several European countries. All participants had de novo coronary calcifications graded as severe by core laboratory assessment, with a mean calcified length of 47.9 mm by quantitative coronary angiography and a mean calcium angle and thickness of 292.5 degrees and 0.96 mm by optical coherence tomography.

“It’s staggering, the level of calcification these patients had. It’s jaw dropping,” Dr. Kereiakes observed.

Intravascular lithotripsy was used to prepare these severely calcified lesions for stenting. The intervention entailed transmission of acoustic waves circumferentially and transmurally at 1 pulse per second through tissue at an effective pressure of about 50 atm. Patients received an average of 69 pulses.

This was not a randomized trial; there was no sham-treated control arm. Instead, the comparator group selected under regulatory guidance was comprised of patients who had received orbital atherectomy for severe coronary calcifications in the earlier, similarly designed ORBIT II trial, which led to FDA marketing approval of that technology.

Key outcomes

The procedural success rate, defined as successful stent delivery with less than a 50% residual stenosis and no in-hospital MACE, was 92.4% in Disrupt CAD III, compared to 83.4% for orbital atherectomy in ORBIT II. The primary safety endpoint of freedom from cardiac death, MI, or target vessel revascularization at 30 days was achieved in 92.2% of patients in the intravascular lithotripsy trial, versus 84.4% in ORBIT II.

The 30-day MACE rate of 7.8% in Disrupt CAD III was primarily driven by periprocedural MIs, which occurred in 6.8% of participants. Only one-third of the MIs were clinically relevant by the Society for Coronary Angiography and Intervention definition. There were two cardiac deaths and three cases of stent thrombosis, all of which were associated with known predictors of the complication. There was 1 case each of dissection, abrupt closure, and perforation, but no instances of slow flow or no reflow at the procedure’s end. Transient lithotripsy-induced left ventricular capture occurred in 41% of patients, but they were benign events with no lasting consequences.

The device was able to cross and deliver acoustic pressure wave therapy to 98.2% of lesions. The mean diameter stenosis preprocedure was 65.1%, dropping to 37.2% post lithotripsy, with a final in-stent residual stenosis diameter of 11.9%, with a 1.7-mm acute gain. The average stent expansion at the site of maximum calcification was 102%, with a minimum stent area of 6.5 mm².

Optical coherence imaging revealed that 67% of treated lesions had circumferential and transmural fractures of both deep and superficial calcium post lithotripsy. Yet outcomes were the same regardless of whether fractures were evident on imaging.

At 30-day follow-up, 72.9% of patients had no angina, up from just 12.6% of participants pre-PCI. Follow-up will continue for 2 years.

Outcomes were similar for the first case done at each participating center and all cases thereafter.

“The ease of use was remarkable,” Dr. Kereiakes recalled. “The learning curve is virtually nonexistent.”
 

The reaction

At a press conference where Dr. Kereiakes presented the Disrupt CAD III results, discussant Allen Jeremias, MD, said he found the results compelling.

“The success rate is high, I think it’s relatively easy to use, as demonstrated, and I think the results are spectacular,” said Dr. Jeremias, director of interventional cardiology research and associate director of the cardiac catheterization laboratory at St. Francis Hospital in Roslyn, N.Y.

Bruce Jancin/MDedge News

[email protected]

SOURCE: Kereiakes DJ. TCT 2020. Late Breaking Clinical Science session 2.

A COVID-19 vaccine could be proven effective within the last months of 2020, with distribution of first doses possible before the end of the year, according to Anthony S. Fauci, MD, director, National Institute of Allergy and Infectious Diseases, Bethesda, Md.

“Given the rate of infection that’s going on in this country, and the distribution of the clinical trial sites involving tens of thousands of volunteers, we project that we will have an answer as to whether or not we have a safe and effective vaccine by November or December,” Dr. Fauci said today in his virtual keynote address during the annual meeting of the American College of Chest Physicians.

“It may come earlier -- this month, in October,” he added in his remarks. “That is unlikely – it is more likely that we’ll have an answer in November and December.”

If that timing does come to pass, Dr. Fauci said, it’s possible that distribution of doses could start at the end of the year, continuing throughout the beginning and middle of 2021.

Although there are no guarantees, Dr. Fauci said he is “cautiously optimistic” regarding the timeline.

He said that his optimism is based in part on animal studies and phase 1 data that demonstrate robust neutralizing antibody responses to a vaccine that are equivalent to, if not greater than, natural infection with the SARS-CoV-2 virus that causes COVID-19.

Rapid development gives reason for hope

Ryan C. Maves, MD, FCCP, a critical care and infectious disease specialist at Naval Medical Center San Diego, said there is reason to be hopeful that a vaccine will be available by the end of the calendar year. He cautioned, however, that this timing is based on the assumption that one of the vaccines will be proven safe and effective very soon.

“We’re lucky to have multiple phase 3 trials using multiple vaccine technologies in different platforms,” Dr. Maves said in a panel discussion following Dr. Fauci’s remarks. “I think the odds are very high that one of them will be effective.”

“I’m hoping that multiple vaccines will be effective,” Dr. Maves added. “Then we’ll be in a good position of determining which is the best of several good options, as a society and as a world.”

COVID-19 vaccine development over the past year has been remarkably fast, especially given the previous record set by the mumps vaccine, which took about four years to go from initial steps to rollout, Dr. Maves noted.

Dr. Fauci said the federal government has taken a “strategic approach” to the COVID-19 vaccine that includes direct involvement in the research and development of six different vaccine candidates, five of which are now in phase 3 trials.

As part of that strategic approach, the study protocols are harmonized to have a common data and safety monitoring board, common primary and secondary endpoints, and an independent statistical group to determine correlates of protection, Dr. Fauci said.

Prioritizing COVID-19 vaccine distribution

Who gets COVID-19 vaccine first will be a challenge for governmental organizations as well as bioethicists, who have proposed different strategies for fairly prioritizing different groups for access.

Reaching communities of color will be an important consideration for prioritization, according to Dr. Maves, given the disproportionate burden of disease on Black and Hispanic individuals, among other such populations.

COVID-19–related hospitalization rates have been substantially higher in communities of color, Dr. Fauci said in his keynote address. Age-adjusted hospitalization rates for Hispanic/Latinx and Black populations are 375 to 368 per 100,000, respectively, compared with just 82 per 100,000 for White non-Hispanics, according to data from the Centers for Disease Control and Prevention.

Outreach to those communities should include building trust in those populations that they will benefit from a safe and effective vaccine, and making sure that the vaccine is available to those communities as quickly as possible, Dr. Maves said.

Dr. Fauci and Dr. Maves provided no disclosures related to their presentations.

[email protected]

A COVID-19 vaccine could be proven effective within the last months of 2020, with distribution of first doses possible before the end of the year, according to Anthony S. Fauci, MD, director, National Institute of Allergy and Infectious Diseases, Bethesda, Md.

“Given the rate of infection that’s going on in this country, and the distribution of the clinical trial sites involving tens of thousands of volunteers, we project that we will have an answer as to whether or not we have a safe and effective vaccine by November or December,” Dr. Fauci said today in his virtual keynote address during the annual meeting of the American College of Chest Physicians.

“It may come earlier -- this month, in October,” he added in his remarks. “That is unlikely – it is more likely that we’ll have an answer in November and December.”

If that timing does come to pass, Dr. Fauci said, it’s possible that distribution of doses could start at the end of the year, continuing throughout the beginning and middle of 2021.

Although there are no guarantees, Dr. Fauci said he is “cautiously optimistic” regarding the timeline.

He said that his optimism is based in part on animal studies and phase 1 data that demonstrate robust neutralizing antibody responses to a vaccine that are equivalent to, if not greater than, natural infection with the SARS-CoV-2 virus that causes COVID-19.

Rapid development gives reason for hope

Ryan C. Maves, MD, FCCP, a critical care and infectious disease specialist at Naval Medical Center San Diego, said there is reason to be hopeful that a vaccine will be available by the end of the calendar year. He cautioned, however, that this timing is based on the assumption that one of the vaccines will be proven safe and effective very soon.

“We’re lucky to have multiple phase 3 trials using multiple vaccine technologies in different platforms,” Dr. Maves said in a panel discussion following Dr. Fauci’s remarks. “I think the odds are very high that one of them will be effective.”

“I’m hoping that multiple vaccines will be effective,” Dr. Maves added. “Then we’ll be in a good position of determining which is the best of several good options, as a society and as a world.”

COVID-19 vaccine development over the past year has been remarkably fast, especially given the previous record set by the mumps vaccine, which took about four years to go from initial steps to rollout, Dr. Maves noted.

Dr. Fauci said the federal government has taken a “strategic approach” to the COVID-19 vaccine that includes direct involvement in the research and development of six different vaccine candidates, five of which are now in phase 3 trials.

As part of that strategic approach, the study protocols are harmonized to have a common data and safety monitoring board, common primary and secondary endpoints, and an independent statistical group to determine correlates of protection, Dr. Fauci said.

Prioritizing COVID-19 vaccine distribution

Who gets COVID-19 vaccine first will be a challenge for governmental organizations as well as bioethicists, who have proposed different strategies for fairly prioritizing different groups for access.

Reaching communities of color will be an important consideration for prioritization, according to Dr. Maves, given the disproportionate burden of disease on Black and Hispanic individuals, among other such populations.

COVID-19–related hospitalization rates have been substantially higher in communities of color, Dr. Fauci said in his keynote address. Age-adjusted hospitalization rates for Hispanic/Latinx and Black populations are 375 to 368 per 100,000, respectively, compared with just 82 per 100,000 for White non-Hispanics, according to data from the Centers for Disease Control and Prevention.

Outreach to those communities should include building trust in those populations that they will benefit from a safe and effective vaccine, and making sure that the vaccine is available to those communities as quickly as possible, Dr. Maves said.

Dr. Fauci and Dr. Maves provided no disclosures related to their presentations.

[email protected]

A COVID-19 vaccine could be proven effective within the last months of 2020, with distribution of first doses possible before the end of the year, according to Anthony S. Fauci, MD, director, National Institute of Allergy and Infectious Diseases, Bethesda, Md.

“Given the rate of infection that’s going on in this country, and the distribution of the clinical trial sites involving tens of thousands of volunteers, we project that we will have an answer as to whether or not we have a safe and effective vaccine by November or December,” Dr. Fauci said today in his virtual keynote address during the annual meeting of the American College of Chest Physicians.

“It may come earlier -- this month, in October,” he added in his remarks. “That is unlikely – it is more likely that we’ll have an answer in November and December.”

If that timing does come to pass, Dr. Fauci said, it’s possible that distribution of doses could start at the end of the year, continuing throughout the beginning and middle of 2021.

Although there are no guarantees, Dr. Fauci said he is “cautiously optimistic” regarding the timeline.

He said that his optimism is based in part on animal studies and phase 1 data that demonstrate robust neutralizing antibody responses to a vaccine that are equivalent to, if not greater than, natural infection with the SARS-CoV-2 virus that causes COVID-19.

Rapid development gives reason for hope

Ryan C. Maves, MD, FCCP, a critical care and infectious disease specialist at Naval Medical Center San Diego, said there is reason to be hopeful that a vaccine will be available by the end of the calendar year. He cautioned, however, that this timing is based on the assumption that one of the vaccines will be proven safe and effective very soon.

“We’re lucky to have multiple phase 3 trials using multiple vaccine technologies in different platforms,” Dr. Maves said in a panel discussion following Dr. Fauci’s remarks. “I think the odds are very high that one of them will be effective.”

“I’m hoping that multiple vaccines will be effective,” Dr. Maves added. “Then we’ll be in a good position of determining which is the best of several good options, as a society and as a world.”

COVID-19 vaccine development over the past year has been remarkably fast, especially given the previous record set by the mumps vaccine, which took about four years to go from initial steps to rollout, Dr. Maves noted.

Dr. Fauci said the federal government has taken a “strategic approach” to the COVID-19 vaccine that includes direct involvement in the research and development of six different vaccine candidates, five of which are now in phase 3 trials.

As part of that strategic approach, the study protocols are harmonized to have a common data and safety monitoring board, common primary and secondary endpoints, and an independent statistical group to determine correlates of protection, Dr. Fauci said.

Prioritizing COVID-19 vaccine distribution

Who gets COVID-19 vaccine first will be a challenge for governmental organizations as well as bioethicists, who have proposed different strategies for fairly prioritizing different groups for access.

Reaching communities of color will be an important consideration for prioritization, according to Dr. Maves, given the disproportionate burden of disease on Black and Hispanic individuals, among other such populations.

COVID-19–related hospitalization rates have been substantially higher in communities of color, Dr. Fauci said in his keynote address. Age-adjusted hospitalization rates for Hispanic/Latinx and Black populations are 375 to 368 per 100,000, respectively, compared with just 82 per 100,000 for White non-Hispanics, according to data from the Centers for Disease Control and Prevention.

Outreach to those communities should include building trust in those populations that they will benefit from a safe and effective vaccine, and making sure that the vaccine is available to those communities as quickly as possible, Dr. Maves said.

Dr. Fauci and Dr. Maves provided no disclosures related to their presentations.

[email protected]

The recall of extended-release metformin continues this month as 76 more lots have been flagged for a possible cancer-causing ingredient.

The Food and Drug Administration announced the latest recall, involving Marksans Pharma Limited and Sun Pharmaceutical Industries products, on Oct. 5. It involves the 500-mg and 700-mg tablets. More than 175 different drug combinations have been recalled since late May.

Consumers can see all the recalled metformin products at this FDA website. The agency says that immediate-release metformin does not appear to have the same contamination problem.

The FDA has been investigating the presence of nitrosamines, known to be possible carcinogens, in the popular diabetes medications since December, when they were first discovered in drugs in other countries. The agency said this month they still do not know the source of nitrosamines in the medications.

The investigation and subsequent recalls follow similar ones for contamination of popular heartburn and blood pressure drugs also for nitrosamines, such as N-Nitrosodimethylamine (NDMA).

The FDA says patients taking metformin products that have been recalled should continue taking the medication until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking the medication without first talking to their doctor.

The agency has asked drug manufacturers to test products before batches are released into the market. The companies must tell the FDA if any product shows levels of nitrosamines above the acceptable limit.

The risk from nitrosamines is not clear. The FDA says they may increase the risk of cancer in people who are exposed to high levels over a long period of time, “but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.”
 

This article first appeared on WebMD.com.

The recall of extended-release metformin continues this month as 76 more lots have been flagged for a possible cancer-causing ingredient.

The Food and Drug Administration announced the latest recall, involving Marksans Pharma Limited and Sun Pharmaceutical Industries products, on Oct. 5. It involves the 500-mg and 700-mg tablets. More than 175 different drug combinations have been recalled since late May.

Consumers can see all the recalled metformin products at this FDA website. The agency says that immediate-release metformin does not appear to have the same contamination problem.

The FDA has been investigating the presence of nitrosamines, known to be possible carcinogens, in the popular diabetes medications since December, when they were first discovered in drugs in other countries. The agency said this month they still do not know the source of nitrosamines in the medications.

The investigation and subsequent recalls follow similar ones for contamination of popular heartburn and blood pressure drugs also for nitrosamines, such as N-Nitrosodimethylamine (NDMA).

The FDA says patients taking metformin products that have been recalled should continue taking the medication until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking the medication without first talking to their doctor.

The agency has asked drug manufacturers to test products before batches are released into the market. The companies must tell the FDA if any product shows levels of nitrosamines above the acceptable limit.

The risk from nitrosamines is not clear. The FDA says they may increase the risk of cancer in people who are exposed to high levels over a long period of time, “but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.”
 

This article first appeared on WebMD.com.

The recall of extended-release metformin continues this month as 76 more lots have been flagged for a possible cancer-causing ingredient.

The Food and Drug Administration announced the latest recall, involving Marksans Pharma Limited and Sun Pharmaceutical Industries products, on Oct. 5. It involves the 500-mg and 700-mg tablets. More than 175 different drug combinations have been recalled since late May.

Consumers can see all the recalled metformin products at this FDA website. The agency says that immediate-release metformin does not appear to have the same contamination problem.

The FDA has been investigating the presence of nitrosamines, known to be possible carcinogens, in the popular diabetes medications since December, when they were first discovered in drugs in other countries. The agency said this month they still do not know the source of nitrosamines in the medications.

The investigation and subsequent recalls follow similar ones for contamination of popular heartburn and blood pressure drugs also for nitrosamines, such as N-Nitrosodimethylamine (NDMA).

The FDA says patients taking metformin products that have been recalled should continue taking the medication until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking the medication without first talking to their doctor.

The agency has asked drug manufacturers to test products before batches are released into the market. The companies must tell the FDA if any product shows levels of nitrosamines above the acceptable limit.

The risk from nitrosamines is not clear. The FDA says they may increase the risk of cancer in people who are exposed to high levels over a long period of time, “but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.”
 

This article first appeared on WebMD.com.

Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).

Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).

“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.

The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.

Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.

NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.

The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.

Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.

The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.

COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).

They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.

Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.

Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).

But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).

Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.

“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”

Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.

During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.

“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”

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

Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).

Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).

“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.

The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.

Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.

NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.

The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.

Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.

The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.

COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).

They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.

Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.

Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).

But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).

Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.

“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”

Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.

During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.

“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”

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

Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).

Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).

“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.

The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.

Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.

NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.

The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.

Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.

The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.

COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).

They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.

Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.

Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).

But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).

Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.

“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”

Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.

During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.

“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”

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

“There’s rue for you, and here’s some for me; we may call it herb of grace o’ Sundays. O, you must wear your rue with a difference.”

— Ophelia in Hamlet by William Shakespeare

The patient was admitted to the hospital for IV fluids, pain control, and observation. The following day she admitted using the leaves of a plant on the trail as a bug repellent, as one time was taught by her grandfather. She rubbed some of the leaves on the brother as well. The grandfather shared some pictures of the bushes, and the plant was identified as Ruta graveolens.

The blisters were deroofed, cleaned with saline, and wrapped with triamcinolone ointment and petrolatum. The patient was also started on a prednisone taper and received analgesics for the severe pain.

Ruta graveolens also known as common rue or herb of grace, is an ornamental plant from the Rutaceae family. This plant is also used as a medicinal herb, condiment, and as an insect repellent. If ingested in large doses, it can cause severe abdominal pain and vomiting. It also can be hepatotoxic.

When applied to the skin and then exposed to the sun, it can cause severe phytophotodermatitis which can mimic a severe second-degree burn. The herb contains furocumarines, such as 8-methoxypsoralen and 5-methoxypsoralen and furoquinoline alkaloids. These chemicals when exposed to UVA radiation cause cell injury and inflammation of the skin. This is considered a phototoxic reaction of the skin, compared with allergic reactions, such as poison ivy dermatitis, which need a prior sensitization to the allergen for the T cells to be activated and cause injury in the skin. Other common plants and fruits that can cause phytophotodermatitis include citrus fruits, figs, carrots, celery, parsnips, parsley, and other wildflowers like hogweed.

Depending on the degree of injury, the patients can be treated with topical corticosteroids, petrolatum wraps, and pain control. In severe cases like our patient, systemic prednisone may help stop the progression of the lesions and help with the inflammation. Skin hyperpigmentation after the initial injury may take months to clear, and some patient can develop scars.

The differential diagnosis should include severe bullous contact dermatitis like exposure to urushiol in poison ivy; second- and third-degree burns; severe medications reactions such Stevens-Johnson syndrome or toxic epidermal necrolysis, and inmunobullous diseases such as bullous lupus erythematosus, pemphigus vulgaris, or bullous pemphigoid. If there is no history of exposure or there are any other systemic symptoms, consider performing a skin biopsy of one of the lesions.

In this patient’s case, the history of exposure and skin findings helped the dermatologist on call make the right diagnosis.
 

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. Email her at [email protected].

References

J Burn Care Res. 2018 Oct 23;39(6):1064-6.

Dermatitis. 2007 Mar;18(1):52-5.

BMJ Case Rep. 2015 Dec 23;2015:bcr2015213388.

“There’s rue for you, and here’s some for me; we may call it herb of grace o’ Sundays. O, you must wear your rue with a difference.”

— Ophelia in Hamlet by William Shakespeare

The patient was admitted to the hospital for IV fluids, pain control, and observation. The following day she admitted using the leaves of a plant on the trail as a bug repellent, as one time was taught by her grandfather. She rubbed some of the leaves on the brother as well. The grandfather shared some pictures of the bushes, and the plant was identified as Ruta graveolens.

The blisters were deroofed, cleaned with saline, and wrapped with triamcinolone ointment and petrolatum. The patient was also started on a prednisone taper and received analgesics for the severe pain.

Ruta graveolens also known as common rue or herb of grace, is an ornamental plant from the Rutaceae family. This plant is also used as a medicinal herb, condiment, and as an insect repellent. If ingested in large doses, it can cause severe abdominal pain and vomiting. It also can be hepatotoxic.

When applied to the skin and then exposed to the sun, it can cause severe phytophotodermatitis which can mimic a severe second-degree burn. The herb contains furocumarines, such as 8-methoxypsoralen and 5-methoxypsoralen and furoquinoline alkaloids. These chemicals when exposed to UVA radiation cause cell injury and inflammation of the skin. This is considered a phototoxic reaction of the skin, compared with allergic reactions, such as poison ivy dermatitis, which need a prior sensitization to the allergen for the T cells to be activated and cause injury in the skin. Other common plants and fruits that can cause phytophotodermatitis include citrus fruits, figs, carrots, celery, parsnips, parsley, and other wildflowers like hogweed.

Depending on the degree of injury, the patients can be treated with topical corticosteroids, petrolatum wraps, and pain control. In severe cases like our patient, systemic prednisone may help stop the progression of the lesions and help with the inflammation. Skin hyperpigmentation after the initial injury may take months to clear, and some patient can develop scars.

The differential diagnosis should include severe bullous contact dermatitis like exposure to urushiol in poison ivy; second- and third-degree burns; severe medications reactions such Stevens-Johnson syndrome or toxic epidermal necrolysis, and inmunobullous diseases such as bullous lupus erythematosus, pemphigus vulgaris, or bullous pemphigoid. If there is no history of exposure or there are any other systemic symptoms, consider performing a skin biopsy of one of the lesions.

In this patient’s case, the history of exposure and skin findings helped the dermatologist on call make the right diagnosis.
 

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. Email her at [email protected].

References

J Burn Care Res. 2018 Oct 23;39(6):1064-6.

Dermatitis. 2007 Mar;18(1):52-5.

BMJ Case Rep. 2015 Dec 23;2015:bcr2015213388.

“There’s rue for you, and here’s some for me; we may call it herb of grace o’ Sundays. O, you must wear your rue with a difference.”

— Ophelia in Hamlet by William Shakespeare

The patient was admitted to the hospital for IV fluids, pain control, and observation. The following day she admitted using the leaves of a plant on the trail as a bug repellent, as one time was taught by her grandfather. She rubbed some of the leaves on the brother as well. The grandfather shared some pictures of the bushes, and the plant was identified as Ruta graveolens.

The blisters were deroofed, cleaned with saline, and wrapped with triamcinolone ointment and petrolatum. The patient was also started on a prednisone taper and received analgesics for the severe pain.

Ruta graveolens also known as common rue or herb of grace, is an ornamental plant from the Rutaceae family. This plant is also used as a medicinal herb, condiment, and as an insect repellent. If ingested in large doses, it can cause severe abdominal pain and vomiting. It also can be hepatotoxic.

When applied to the skin and then exposed to the sun, it can cause severe phytophotodermatitis which can mimic a severe second-degree burn. The herb contains furocumarines, such as 8-methoxypsoralen and 5-methoxypsoralen and furoquinoline alkaloids. These chemicals when exposed to UVA radiation cause cell injury and inflammation of the skin. This is considered a phototoxic reaction of the skin, compared with allergic reactions, such as poison ivy dermatitis, which need a prior sensitization to the allergen for the T cells to be activated and cause injury in the skin. Other common plants and fruits that can cause phytophotodermatitis include citrus fruits, figs, carrots, celery, parsnips, parsley, and other wildflowers like hogweed.

Depending on the degree of injury, the patients can be treated with topical corticosteroids, petrolatum wraps, and pain control. In severe cases like our patient, systemic prednisone may help stop the progression of the lesions and help with the inflammation. Skin hyperpigmentation after the initial injury may take months to clear, and some patient can develop scars.

The differential diagnosis should include severe bullous contact dermatitis like exposure to urushiol in poison ivy; second- and third-degree burns; severe medications reactions such Stevens-Johnson syndrome or toxic epidermal necrolysis, and inmunobullous diseases such as bullous lupus erythematosus, pemphigus vulgaris, or bullous pemphigoid. If there is no history of exposure or there are any other systemic symptoms, consider performing a skin biopsy of one of the lesions.

In this patient’s case, the history of exposure and skin findings helped the dermatologist on call make the right diagnosis.
 

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. Email her at [email protected].

References

J Burn Care Res. 2018 Oct 23;39(6):1064-6.

Dermatitis. 2007 Mar;18(1):52-5.

BMJ Case Rep. 2015 Dec 23;2015:bcr2015213388.

As the COVID-19 pandemic continues to chug along, some communities feel it slowing to a pace at which they might feel comfortable about a return to, if not quite “business as usual,” at least “business as sort of normal-ish.” They are ready to accept a level of disease that signals they have reached a steady state. However, in other communities, the virus has picked up speed and is threatening to overwhelm the medical infrastructure. If you are in one of those fortunate and skillfully managed states in which folks are beginning to talk seriously, but with little evidence, that it is time to return to normal, it is probably far too early. Are there any metrics that could be applied to make the decision to ease restrictions more rational?

Courtesy Dr. William G. Wilkoff

Eons ago in pandemic terms, the World Health Organization in Thailand published a list of criteria to aid in determining when a community could consider lifting the limits that seemed to have been effective in halting transmission of the virus (“Transitioning to and maintaining a steady state of low-level or no transmission,” WHO, Thailand, 2020 Apr 18). While much more has been learned about the behavior of the virus since the spring of 2020, the criteria from the WHO in Thailand are worth considering.

Here is my summary of their criteria for returning to normalcy. First, virus transmission is controlled to the point that only sporadic cases and small clusters exist, and that all of these are traceable in origin. Second, health care and public health systems are in place with sufficient capacities to manage a shift from detection to treatment should the case load increase dramatically; this capacity should include detection, testing, isolation, and quarantine. Third, outbreaks in high-risk populations such as nursing homes have been minimized. Fourth, workplace prevention strategies are in place and have been demonstrated to be effective. Fifth, risk of imported cases is at manageable levels. Finally, communities are engaged.

It is hard to argue with the rationale behind each of these criteria. However, the United States is not Thailand, and just thinking about how this country would go about meeting those criteria provides a window into some of the reasons why we have done so poorly and will continue to be challenged in dealing with the pandemic.

First, notice that the criteria make no mention of a vaccine. One gets the sense that from the top down our country is banking too heavily on the effectiveness and widespread delivery of a vaccine. Even if and when a vaccine is developed and delivered, all of these criteria still must be met and kept in mind for a future pandemic.

Second, the criteria call for an effective health care system, but it is abundantly clear that the United States does not have a cohesive health care system and probably won’t for the foreseeable future. The best we can hope for is individual states cobbling together their own systems, which may in turn serve as examples for those states who haven’t had the foresight. We have had a public health system of sorts, but its credibility and effectiveness has been neutered to the point that again we must rely on each state’s ability to see through the haze and create it’s own systems for detection, testing, tracking, isolating, and quarantining – often with little help in materiel support from the federal government. The sliver of good news is that, after a bit of a stumbling start, detecting and limiting the importation of cases from abroad is being addressed.

We continue to hear and see evidence that there are segments of the population who are not engaged in the activities that we have learned are necessary to stabilize the pandemic. My sense is that those people represent a very small minority. But, it is probably large enough to make the route to a steady state on a national level long and painful. This unfortunately is to be expected in a country that was built on a framework of personal freedoms. The best you can hope for in achieving a steady state is to live in one of the states that seems to be achieving the fine balance between personal freedoms and the common good.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

As the COVID-19 pandemic continues to chug along, some communities feel it slowing to a pace at which they might feel comfortable about a return to, if not quite “business as usual,” at least “business as sort of normal-ish.” They are ready to accept a level of disease that signals they have reached a steady state. However, in other communities, the virus has picked up speed and is threatening to overwhelm the medical infrastructure. If you are in one of those fortunate and skillfully managed states in which folks are beginning to talk seriously, but with little evidence, that it is time to return to normal, it is probably far too early. Are there any metrics that could be applied to make the decision to ease restrictions more rational?

Courtesy Dr. William G. Wilkoff

Eons ago in pandemic terms, the World Health Organization in Thailand published a list of criteria to aid in determining when a community could consider lifting the limits that seemed to have been effective in halting transmission of the virus (“Transitioning to and maintaining a steady state of low-level or no transmission,” WHO, Thailand, 2020 Apr 18). While much more has been learned about the behavior of the virus since the spring of 2020, the criteria from the WHO in Thailand are worth considering.

Here is my summary of their criteria for returning to normalcy. First, virus transmission is controlled to the point that only sporadic cases and small clusters exist, and that all of these are traceable in origin. Second, health care and public health systems are in place with sufficient capacities to manage a shift from detection to treatment should the case load increase dramatically; this capacity should include detection, testing, isolation, and quarantine. Third, outbreaks in high-risk populations such as nursing homes have been minimized. Fourth, workplace prevention strategies are in place and have been demonstrated to be effective. Fifth, risk of imported cases is at manageable levels. Finally, communities are engaged.

It is hard to argue with the rationale behind each of these criteria. However, the United States is not Thailand, and just thinking about how this country would go about meeting those criteria provides a window into some of the reasons why we have done so poorly and will continue to be challenged in dealing with the pandemic.

First, notice that the criteria make no mention of a vaccine. One gets the sense that from the top down our country is banking too heavily on the effectiveness and widespread delivery of a vaccine. Even if and when a vaccine is developed and delivered, all of these criteria still must be met and kept in mind for a future pandemic.

Second, the criteria call for an effective health care system, but it is abundantly clear that the United States does not have a cohesive health care system and probably won’t for the foreseeable future. The best we can hope for is individual states cobbling together their own systems, which may in turn serve as examples for those states who haven’t had the foresight. We have had a public health system of sorts, but its credibility and effectiveness has been neutered to the point that again we must rely on each state’s ability to see through the haze and create it’s own systems for detection, testing, tracking, isolating, and quarantining – often with little help in materiel support from the federal government. The sliver of good news is that, after a bit of a stumbling start, detecting and limiting the importation of cases from abroad is being addressed.

We continue to hear and see evidence that there are segments of the population who are not engaged in the activities that we have learned are necessary to stabilize the pandemic. My sense is that those people represent a very small minority. But, it is probably large enough to make the route to a steady state on a national level long and painful. This unfortunately is to be expected in a country that was built on a framework of personal freedoms. The best you can hope for in achieving a steady state is to live in one of the states that seems to be achieving the fine balance between personal freedoms and the common good.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

As the COVID-19 pandemic continues to chug along, some communities feel it slowing to a pace at which they might feel comfortable about a return to, if not quite “business as usual,” at least “business as sort of normal-ish.” They are ready to accept a level of disease that signals they have reached a steady state. However, in other communities, the virus has picked up speed and is threatening to overwhelm the medical infrastructure. If you are in one of those fortunate and skillfully managed states in which folks are beginning to talk seriously, but with little evidence, that it is time to return to normal, it is probably far too early. Are there any metrics that could be applied to make the decision to ease restrictions more rational?

Courtesy Dr. William G. Wilkoff

Eons ago in pandemic terms, the World Health Organization in Thailand published a list of criteria to aid in determining when a community could consider lifting the limits that seemed to have been effective in halting transmission of the virus (“Transitioning to and maintaining a steady state of low-level or no transmission,” WHO, Thailand, 2020 Apr 18). While much more has been learned about the behavior of the virus since the spring of 2020, the criteria from the WHO in Thailand are worth considering.

Here is my summary of their criteria for returning to normalcy. First, virus transmission is controlled to the point that only sporadic cases and small clusters exist, and that all of these are traceable in origin. Second, health care and public health systems are in place with sufficient capacities to manage a shift from detection to treatment should the case load increase dramatically; this capacity should include detection, testing, isolation, and quarantine. Third, outbreaks in high-risk populations such as nursing homes have been minimized. Fourth, workplace prevention strategies are in place and have been demonstrated to be effective. Fifth, risk of imported cases is at manageable levels. Finally, communities are engaged.

It is hard to argue with the rationale behind each of these criteria. However, the United States is not Thailand, and just thinking about how this country would go about meeting those criteria provides a window into some of the reasons why we have done so poorly and will continue to be challenged in dealing with the pandemic.

First, notice that the criteria make no mention of a vaccine. One gets the sense that from the top down our country is banking too heavily on the effectiveness and widespread delivery of a vaccine. Even if and when a vaccine is developed and delivered, all of these criteria still must be met and kept in mind for a future pandemic.

Second, the criteria call for an effective health care system, but it is abundantly clear that the United States does not have a cohesive health care system and probably won’t for the foreseeable future. The best we can hope for is individual states cobbling together their own systems, which may in turn serve as examples for those states who haven’t had the foresight. We have had a public health system of sorts, but its credibility and effectiveness has been neutered to the point that again we must rely on each state’s ability to see through the haze and create it’s own systems for detection, testing, tracking, isolating, and quarantining – often with little help in materiel support from the federal government. The sliver of good news is that, after a bit of a stumbling start, detecting and limiting the importation of cases from abroad is being addressed.

We continue to hear and see evidence that there are segments of the population who are not engaged in the activities that we have learned are necessary to stabilize the pandemic. My sense is that those people represent a very small minority. But, it is probably large enough to make the route to a steady state on a national level long and painful. This unfortunately is to be expected in a country that was built on a framework of personal freedoms. The best you can hope for in achieving a steady state is to live in one of the states that seems to be achieving the fine balance between personal freedoms and the common good.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Ticagrelor monotherapy after just 3 months of dual-antiplatelet therapy (DAPT) in patients with ST-elevation myocardial infarction treated with drug-eluting stents proved a winning strategy in TICO-STEMI, a major randomized trial.

“This is the first report assessing the feasibility of ticagrelor monotherapy after short-term DAPT for STEMI patients with drug-eluting stents,” Byeong-Keuk Kim, MD, PhD, noted at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.

The positive results were consistent with the earlier TWILIGHT study (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention), which also showed clinical benefit at 1 year for 3 months of DAPT followed by ticagrelor (Brilinta) monotherapy, albeit only in PCI patients without an acute coronary syndrome (ACS) or with non-STEMI ACS (N Engl J Med. 2019 Nov 21;381[21]:2032-42).

TICO-STEMI was a prespecified substudy involving the 1,103 STEMI patients included in the previously reported parent 38-center South Korean TICO (Ticagrelor With or Without Aspirin in Acute Coronary Syndrome After PCI) study of 3,056 ACS patients treated with a second-generation ultrathin biodegradable polymer-coated sirolimus-eluting stent (JAMA. 2020 Jun 16;323[23]:2407-16).

The primary outcome in TICO-STEMI was the 12-month composite rate of net adverse clinical events, composed of major bleeding, all-cause mortality, acute MI, stroke, stent thrombosis, or target vessel revascularization. In an intention-to-treat analysis, the rate was 5.0% in the 12-month DAPT group and 3.7% with ticagrelor monotherapy after 3 months of DAPT, for a 27% relative risk reduction which didn’t achieve statistical significance. However, in an as-treated analysis, the between-group difference in the primary endpoint was stronger: a 5.2% incidence with 12 months of DAPT and 2.3% with ticagrelor monotherapy, for a relative risk reduction of 56%, which was statistically significant.

Major bleeding, one of two key secondary endpoints, was a different story: The incidence within 12 months by intention-to-treat was 2.9% with 12 months of DAPT compared to 0.9% with ticagrelor monotherapy, for a statistically significant 68% relative risk reduction in favor of ticagrelor monotherapy. In contrast, there was no between-group difference in the other secondary endpoint composed of major adverse cardio- and cerebrovascular events: 2.7% with ticagrelor monotherapy, 2.5% with 12 months of DAPT.

In the subgroup of TICO-STEMI patients at high bleeding risk, ticagrelor monotherapy was associated with a 12-month major bleeding rate of 1.8%, compared to 6.3% with a full year of DAPT. Conversely, in patients who underwent complex PCI, ticagrelor monotherapy was associated with a 4.9% rate of major adverse cardio- and cerebrovascular events through 1 year, numerically greater than but not statistically significantly different from the 2.7% rate with 12 months of DAPT.

Dr. Kim noted that the study had several limitations: It was open label, had no placebo control, and was underpowered to draw definite conclusions regarding the merits of dropping aspirin and continuing ticagrelor after 3 months in STEMI patients.

“Our findings should be interpreted with caution and call for confirmatory randomized trials,” he stressed.

Session comoderator Roxana Mehran, MD, said she “wholeheartedly” agrees with that assessment.

“We really do need a future trial, and we’re working to design TWILIGHT-STEMI,” a large randomized follow-up to the TWILIGHT trial, which she directed.

“I often imagine that we can have an even shorter duration of aspirin and ticagrelor and go to monotherapy sooner than 3 months in this very, very important subgroup,” added Dr. Mehran, professor of medicine, professor of population science and policy, and director of interventional cardiovascular research and clinical trials at the Icahn School of Medicine at Mount Sinai, New York.

Discussant Marco Valgimigli, MD, PhD, of University Hospital in Bern, Switzerland, calculated that the number-needed-to-treat with ticagrelor monotherapy rather than 12 months of DAPT in order to prevent one additional major bleeding event in TICO-STEMI participants at high bleeding risk was 22, as compared to an NNT of 77 in those without high bleeding risk.

MDedge News

[email protected]

Ticagrelor monotherapy after just 3 months of dual-antiplatelet therapy (DAPT) in patients with ST-elevation myocardial infarction treated with drug-eluting stents proved a winning strategy in TICO-STEMI, a major randomized trial.

“This is the first report assessing the feasibility of ticagrelor monotherapy after short-term DAPT for STEMI patients with drug-eluting stents,” Byeong-Keuk Kim, MD, PhD, noted at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.

The positive results were consistent with the earlier TWILIGHT study (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention), which also showed clinical benefit at 1 year for 3 months of DAPT followed by ticagrelor (Brilinta) monotherapy, albeit only in PCI patients without an acute coronary syndrome (ACS) or with non-STEMI ACS (N Engl J Med. 2019 Nov 21;381[21]:2032-42).

TICO-STEMI was a prespecified substudy involving the 1,103 STEMI patients included in the previously reported parent 38-center South Korean TICO (Ticagrelor With or Without Aspirin in Acute Coronary Syndrome After PCI) study of 3,056 ACS patients treated with a second-generation ultrathin biodegradable polymer-coated sirolimus-eluting stent (JAMA. 2020 Jun 16;323[23]:2407-16).

The primary outcome in TICO-STEMI was the 12-month composite rate of net adverse clinical events, composed of major bleeding, all-cause mortality, acute MI, stroke, stent thrombosis, or target vessel revascularization. In an intention-to-treat analysis, the rate was 5.0% in the 12-month DAPT group and 3.7% with ticagrelor monotherapy after 3 months of DAPT, for a 27% relative risk reduction which didn’t achieve statistical significance. However, in an as-treated analysis, the between-group difference in the primary endpoint was stronger: a 5.2% incidence with 12 months of DAPT and 2.3% with ticagrelor monotherapy, for a relative risk reduction of 56%, which was statistically significant.

Major bleeding, one of two key secondary endpoints, was a different story: The incidence within 12 months by intention-to-treat was 2.9% with 12 months of DAPT compared to 0.9% with ticagrelor monotherapy, for a statistically significant 68% relative risk reduction in favor of ticagrelor monotherapy. In contrast, there was no between-group difference in the other secondary endpoint composed of major adverse cardio- and cerebrovascular events: 2.7% with ticagrelor monotherapy, 2.5% with 12 months of DAPT.

In the subgroup of TICO-STEMI patients at high bleeding risk, ticagrelor monotherapy was associated with a 12-month major bleeding rate of 1.8%, compared to 6.3% with a full year of DAPT. Conversely, in patients who underwent complex PCI, ticagrelor monotherapy was associated with a 4.9% rate of major adverse cardio- and cerebrovascular events through 1 year, numerically greater than but not statistically significantly different from the 2.7% rate with 12 months of DAPT.

Dr. Kim noted that the study had several limitations: It was open label, had no placebo control, and was underpowered to draw definite conclusions regarding the merits of dropping aspirin and continuing ticagrelor after 3 months in STEMI patients.

“Our findings should be interpreted with caution and call for confirmatory randomized trials,” he stressed.

Session comoderator Roxana Mehran, MD, said she “wholeheartedly” agrees with that assessment.

“We really do need a future trial, and we’re working to design TWILIGHT-STEMI,” a large randomized follow-up to the TWILIGHT trial, which she directed.

“I often imagine that we can have an even shorter duration of aspirin and ticagrelor and go to monotherapy sooner than 3 months in this very, very important subgroup,” added Dr. Mehran, professor of medicine, professor of population science and policy, and director of interventional cardiovascular research and clinical trials at the Icahn School of Medicine at Mount Sinai, New York.

Discussant Marco Valgimigli, MD, PhD, of University Hospital in Bern, Switzerland, calculated that the number-needed-to-treat with ticagrelor monotherapy rather than 12 months of DAPT in order to prevent one additional major bleeding event in TICO-STEMI participants at high bleeding risk was 22, as compared to an NNT of 77 in those without high bleeding risk.

MDedge News

[email protected]

Ticagrelor monotherapy after just 3 months of dual-antiplatelet therapy (DAPT) in patients with ST-elevation myocardial infarction treated with drug-eluting stents proved a winning strategy in TICO-STEMI, a major randomized trial.

“This is the first report assessing the feasibility of ticagrelor monotherapy after short-term DAPT for STEMI patients with drug-eluting stents,” Byeong-Keuk Kim, MD, PhD, noted at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.

The positive results were consistent with the earlier TWILIGHT study (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention), which also showed clinical benefit at 1 year for 3 months of DAPT followed by ticagrelor (Brilinta) monotherapy, albeit only in PCI patients without an acute coronary syndrome (ACS) or with non-STEMI ACS (N Engl J Med. 2019 Nov 21;381[21]:2032-42).

TICO-STEMI was a prespecified substudy involving the 1,103 STEMI patients included in the previously reported parent 38-center South Korean TICO (Ticagrelor With or Without Aspirin in Acute Coronary Syndrome After PCI) study of 3,056 ACS patients treated with a second-generation ultrathin biodegradable polymer-coated sirolimus-eluting stent (JAMA. 2020 Jun 16;323[23]:2407-16).

The primary outcome in TICO-STEMI was the 12-month composite rate of net adverse clinical events, composed of major bleeding, all-cause mortality, acute MI, stroke, stent thrombosis, or target vessel revascularization. In an intention-to-treat analysis, the rate was 5.0% in the 12-month DAPT group and 3.7% with ticagrelor monotherapy after 3 months of DAPT, for a 27% relative risk reduction which didn’t achieve statistical significance. However, in an as-treated analysis, the between-group difference in the primary endpoint was stronger: a 5.2% incidence with 12 months of DAPT and 2.3% with ticagrelor monotherapy, for a relative risk reduction of 56%, which was statistically significant.

Major bleeding, one of two key secondary endpoints, was a different story: The incidence within 12 months by intention-to-treat was 2.9% with 12 months of DAPT compared to 0.9% with ticagrelor monotherapy, for a statistically significant 68% relative risk reduction in favor of ticagrelor monotherapy. In contrast, there was no between-group difference in the other secondary endpoint composed of major adverse cardio- and cerebrovascular events: 2.7% with ticagrelor monotherapy, 2.5% with 12 months of DAPT.

In the subgroup of TICO-STEMI patients at high bleeding risk, ticagrelor monotherapy was associated with a 12-month major bleeding rate of 1.8%, compared to 6.3% with a full year of DAPT. Conversely, in patients who underwent complex PCI, ticagrelor monotherapy was associated with a 4.9% rate of major adverse cardio- and cerebrovascular events through 1 year, numerically greater than but not statistically significantly different from the 2.7% rate with 12 months of DAPT.

Dr. Kim noted that the study had several limitations: It was open label, had no placebo control, and was underpowered to draw definite conclusions regarding the merits of dropping aspirin and continuing ticagrelor after 3 months in STEMI patients.

“Our findings should be interpreted with caution and call for confirmatory randomized trials,” he stressed.

Session comoderator Roxana Mehran, MD, said she “wholeheartedly” agrees with that assessment.

“We really do need a future trial, and we’re working to design TWILIGHT-STEMI,” a large randomized follow-up to the TWILIGHT trial, which she directed.

“I often imagine that we can have an even shorter duration of aspirin and ticagrelor and go to monotherapy sooner than 3 months in this very, very important subgroup,” added Dr. Mehran, professor of medicine, professor of population science and policy, and director of interventional cardiovascular research and clinical trials at the Icahn School of Medicine at Mount Sinai, New York.

Discussant Marco Valgimigli, MD, PhD, of University Hospital in Bern, Switzerland, calculated that the number-needed-to-treat with ticagrelor monotherapy rather than 12 months of DAPT in order to prevent one additional major bleeding event in TICO-STEMI participants at high bleeding risk was 22, as compared to an NNT of 77 in those without high bleeding risk.

MDedge News

[email protected]

Medicare officials must soon decide whether to kick off next year with a shift of money away from specialties centered around procedures and toward primary care and other fields more focused on office visits.

A planned overhaul of reimbursement for evaluation and management (E/M) services emerged as perhaps the most contentious issue connected to Medicare’s 2021 payment policies for clinicians.

roobcio/Thinkstock

The Centers for Medicare & Medicaid Services (CMS) included the planned E/M overhaul — and accompanying offsets — in the draft 2021 physician fee schedule, released in August. The draft fee schedule drew at least 45,675 responses by October 5, the deadline for offering comments, with many of the responses addressing the E/M overhaul.

The influential Medicare Payment Advisory Commission (MedPAC) “strongly” endorsed the “budget-neutral” approach taken with the E/M overhaul. This planned reshuffling of payments is a step toward addressing a shortfall of primary care clinicians, inasmuch as it would help make this field more financially appealing, MedPAC said in an October 2 letter to CMS.

In contrast, physician organizations, including the American Medical Association (AMA), asked CMS to waive or revise the budget-neutral aspect of the E/M overhaul. Among the specialties slated for reductions are those deeply involved with the response to the pandemic, wrote James L. Madara, AMA’s chief executive officer, in an October 5 comment to CMS. Emergency medicine as a field would see a 6% cut, and infectious disease specialists, a 4% reduction.

“Payment reductions of this magnitude would be a major problem at any time, but to impose cuts of this magnitude during or immediately after the COVID-19 pandemic, including steep cuts to many of the specialties that have been on the front lines in efforts to treat patients in places with widespread infection, is unconscionable,” Madara wrote.

Madara also said specialties scheduled for payment reductions include those least able to make up for the lack of in-person care as a result of the uptick in telehealth during the pandemic.

A chart in the draft physician fee schedule (Table 90) shows reductions for many specialties that do not routinely bill for office visits. The table shows an 8% cut for anesthesiologists, a 7% cut for general surgeons, and a 6% cut for ophthalmologists. Table 90 also shows an estimated 11% reduction for radiologists and a 9% drop for pathologists.

The draft rule notes that these figures are based upon estimates of aggregate allowed charges across all services, so they may not reflect what any particular clinician might receive.

In total, Table 90 shows how the E/M changes and connected offsets would affect more than 50 fields of medicine. The proposal includes a 17% expected increase for endocrinologists and a 14% bump for those in hematology/oncology. There are expected increases of 13% for family practice and 4% for internal medicine.

This reshuffling of payments among specialties is only part of the 2021 E/M overhaul. There’s strong support for other aspects, making it unlikely that CMS would consider dropping the plan entirely.

“CMS’ new office visit policy will lead to significant administrative burden reduction and will better describe and recognize the resources involved in clinical office visits as they are performed today,” AMA’s Madara wrote in his comment.

Changes for the billing framework for E/M slated to start in 2021 are the result of substantial collaboration by an AMA-convened work group, which brought together more than 170 state medical and specialty societies, Madara said in his comment.

CMS has been developing this plan for several years. It outlined this 2021 E/M overhaul in the 2020 Medicare physician fee schedule finalized last year.

Madara urged CMS to proceed with the E/M changes but also “exercise the full breadth and depth of its administrative authority” to avoid or minimize the planned cuts.

“To be clear, we are not asking CMS to phase in implementation of the E/M changes but rather to phase in the payment reductions for certain specialties and health professionals in 2021 due to budget neutrality,” he wrote.

Other groups asking CMS to waive the budget-neutrality requirement include the American College of Physicians, the American College of Emergency Physicians, the American Society for Radiation Oncology, and the American Society of Neuroradiology.

The American Academy of Family Physicians (AAFP) asked CMS to temporarily waive the budget-neutrality requirement and pressed the agency to maintain the underlying principle of the E/M overhaul.

“Should HHS [Department of Health and Human Services] use its authority to waive budget neutrality, we also recommend that CMS finalize a reinstatement plan for the conversion factor reductions that provides physician practices with ample time to prepare and does not result in a financial cliff,” wrote John S. Cullen, MD, board chair for AAFP, in a September 28 comment to CMS.

Owing to the declaration of a public health emergency, HHS could use a special provision known as 1135 waiver authority to waive budget-neutrality requirements, Cullen wrote.

“The AAFP understands that HHS’ authority is limited by the timing of the end of the public health emergency, but we believe that this approach will provide Congress with needed time to enact an accompanying legislative solution,” he wrote.
 

Lawmakers weigh in

Lawmakers in both political parties have asked CMS to reconsider the offsets in the E/M overhaul.

Rep. Michael C. Burgess, MD (R-TX), who practiced as an obstetrician before joining Congress, in October introduced a bill with Rep. Bobby Rush (D-IL) that would provide for a 1-year waiver of budget-neutrality adjustments under the Medicare physician fee schedule.

Burgess and Rush were among the more than 160 members of Congress who signed a September letter to CMS asking the agency to act on its own to drop the budget-neutrality requirement. In the letter, led by Rep. Roger Marshall, MD (R-KS), the lawmakers acknowledge the usual legal requirements for CMS to offset payment increases in the physician fee schedule with cuts. But the lawmakers said the national public health emergency allows CMS to work around this.

“Given the effects of the COVID-19 pandemic, we believe you have the regulatory authority to immediately address these inequities,” the lawmakers wrote. “There is also the need to consider how the outbreak will be in the fall/winter months and if postponing certain elective procedures will go back into effect, per CMS’ recommendations.

“While we understand that legislative action may also be required to address this issue, given the January 1, 2021 effective date, we would ask you to take immediate actions to delay or mitigate these cuts while allowing the scheduled increases to go into effect,” the lawmakers said in closing their letter. “This approach will give Congress sufficient time to develop a meaningful solution and to address these looming needs.”

Another option might be for CMS to preserve the budget-neutrality claim for the 2021 physician fee schedule but soften the blow on specialties, Brian Fortune, president of the consulting firm Farragut Square Group, told Medscape Medical News. A former staffer for Republican leadership in the House of Representatives, Fortune has for more than 20 years followed Medicare policy.

The agency could redo some of the assumptions used in estimating the offsets, he said, adding that in the draft rule, CMS appears to be seeking feedback that could help it with new calculations.

“CMS has been looking for a way out,” Fortune said. “CMS could remodel the assumptions, and the cuts could drop by half or more.

“The agency has several options to get creative as the need arises,” he said.

“Overvalued” vs “devalued”

In its comment to CMS, though, MedPAC argued strongly for maintaining the offsets. The commission has for several years been investigating ways to use Medicare’s payment policies as a tool to boost the ranks of clinicians who provide primary care.

A reshuffling of payments among specialties is needed to address a known imbalance in which Medicare for many years has “overvalued” procedures at the expense of other medical care, wrote Michael E. Chernew, PhD, the chairman of MedPAC, in an October 2 comment to CMS.

“Some types of services — such as procedures, imaging, and tests — experience efficiency gains over time, as advances in technology, technique, and clinical practice enable clinicians to deliver them faster,” he wrote. “However, E&M office/outpatient visits do not lend themselves to such efficiency gains because they consist largely of activities that require the clinician’s time.”

Medicare’s payment policies have thus “passively devalued” the time many clinicians spend on office visits, helping to skew the decisions of young physicians toward specialties, according to Chernew.

Reshuffling payment away from specialties that are now “overvalued” is needed to “remedy several years of passive devaluation,” he wrote.

The median income in 2018 for primary care physicians was $243,000 in 2018, whereas that of specialists such as surgeons was $426,000, Chernew said in the letter, citing MedPAC research.

These figures echo the findings of Medscape’s most recent annual physician compensation report.

As one of the largest buyers of medical services, Medicare has significant influence on the practice of medicine in the United States. In 2018 alone, Medicare directly paid $70.5 billion for clinician services. Its payment policies already may have shaped the pool of clinicians available to treat people enrolled in Medicare, which covers those aged 65 years and older, Chernew said.

“The US has over three times as many specialists as primary care physicians, which could explain why MedPAC’s annual survey of Medicare beneficiaries has repeatedly found that beneficiaries who are looking for a new physician report having an easier time finding a new specialist than a new primary care provider,” he wrote.

“Access to primary care physicians could worsen in the future as the number of primary care physicians in the US, after remaining flat for several years, has actually started to decline,” Chernew said.

This article first appeared on Medscape.com.

Medicare officials must soon decide whether to kick off next year with a shift of money away from specialties centered around procedures and toward primary care and other fields more focused on office visits.

A planned overhaul of reimbursement for evaluation and management (E/M) services emerged as perhaps the most contentious issue connected to Medicare’s 2021 payment policies for clinicians.

roobcio/Thinkstock

The Centers for Medicare & Medicaid Services (CMS) included the planned E/M overhaul — and accompanying offsets — in the draft 2021 physician fee schedule, released in August. The draft fee schedule drew at least 45,675 responses by October 5, the deadline for offering comments, with many of the responses addressing the E/M overhaul.

The influential Medicare Payment Advisory Commission (MedPAC) “strongly” endorsed the “budget-neutral” approach taken with the E/M overhaul. This planned reshuffling of payments is a step toward addressing a shortfall of primary care clinicians, inasmuch as it would help make this field more financially appealing, MedPAC said in an October 2 letter to CMS.

In contrast, physician organizations, including the American Medical Association (AMA), asked CMS to waive or revise the budget-neutral aspect of the E/M overhaul. Among the specialties slated for reductions are those deeply involved with the response to the pandemic, wrote James L. Madara, AMA’s chief executive officer, in an October 5 comment to CMS. Emergency medicine as a field would see a 6% cut, and infectious disease specialists, a 4% reduction.

“Payment reductions of this magnitude would be a major problem at any time, but to impose cuts of this magnitude during or immediately after the COVID-19 pandemic, including steep cuts to many of the specialties that have been on the front lines in efforts to treat patients in places with widespread infection, is unconscionable,” Madara wrote.

Madara also said specialties scheduled for payment reductions include those least able to make up for the lack of in-person care as a result of the uptick in telehealth during the pandemic.

A chart in the draft physician fee schedule (Table 90) shows reductions for many specialties that do not routinely bill for office visits. The table shows an 8% cut for anesthesiologists, a 7% cut for general surgeons, and a 6% cut for ophthalmologists. Table 90 also shows an estimated 11% reduction for radiologists and a 9% drop for pathologists.

The draft rule notes that these figures are based upon estimates of aggregate allowed charges across all services, so they may not reflect what any particular clinician might receive.

In total, Table 90 shows how the E/M changes and connected offsets would affect more than 50 fields of medicine. The proposal includes a 17% expected increase for endocrinologists and a 14% bump for those in hematology/oncology. There are expected increases of 13% for family practice and 4% for internal medicine.

This reshuffling of payments among specialties is only part of the 2021 E/M overhaul. There’s strong support for other aspects, making it unlikely that CMS would consider dropping the plan entirely.

“CMS’ new office visit policy will lead to significant administrative burden reduction and will better describe and recognize the resources involved in clinical office visits as they are performed today,” AMA’s Madara wrote in his comment.

Changes for the billing framework for E/M slated to start in 2021 are the result of substantial collaboration by an AMA-convened work group, which brought together more than 170 state medical and specialty societies, Madara said in his comment.

CMS has been developing this plan for several years. It outlined this 2021 E/M overhaul in the 2020 Medicare physician fee schedule finalized last year.

Madara urged CMS to proceed with the E/M changes but also “exercise the full breadth and depth of its administrative authority” to avoid or minimize the planned cuts.

“To be clear, we are not asking CMS to phase in implementation of the E/M changes but rather to phase in the payment reductions for certain specialties and health professionals in 2021 due to budget neutrality,” he wrote.

Other groups asking CMS to waive the budget-neutrality requirement include the American College of Physicians, the American College of Emergency Physicians, the American Society for Radiation Oncology, and the American Society of Neuroradiology.

The American Academy of Family Physicians (AAFP) asked CMS to temporarily waive the budget-neutrality requirement and pressed the agency to maintain the underlying principle of the E/M overhaul.

“Should HHS [Department of Health and Human Services] use its authority to waive budget neutrality, we also recommend that CMS finalize a reinstatement plan for the conversion factor reductions that provides physician practices with ample time to prepare and does not result in a financial cliff,” wrote John S. Cullen, MD, board chair for AAFP, in a September 28 comment to CMS.

Owing to the declaration of a public health emergency, HHS could use a special provision known as 1135 waiver authority to waive budget-neutrality requirements, Cullen wrote.

“The AAFP understands that HHS’ authority is limited by the timing of the end of the public health emergency, but we believe that this approach will provide Congress with needed time to enact an accompanying legislative solution,” he wrote.
 

Lawmakers weigh in

Lawmakers in both political parties have asked CMS to reconsider the offsets in the E/M overhaul.

Rep. Michael C. Burgess, MD (R-TX), who practiced as an obstetrician before joining Congress, in October introduced a bill with Rep. Bobby Rush (D-IL) that would provide for a 1-year waiver of budget-neutrality adjustments under the Medicare physician fee schedule.

Burgess and Rush were among the more than 160 members of Congress who signed a September letter to CMS asking the agency to act on its own to drop the budget-neutrality requirement. In the letter, led by Rep. Roger Marshall, MD (R-KS), the lawmakers acknowledge the usual legal requirements for CMS to offset payment increases in the physician fee schedule with cuts. But the lawmakers said the national public health emergency allows CMS to work around this.

“Given the effects of the COVID-19 pandemic, we believe you have the regulatory authority to immediately address these inequities,” the lawmakers wrote. “There is also the need to consider how the outbreak will be in the fall/winter months and if postponing certain elective procedures will go back into effect, per CMS’ recommendations.

“While we understand that legislative action may also be required to address this issue, given the January 1, 2021 effective date, we would ask you to take immediate actions to delay or mitigate these cuts while allowing the scheduled increases to go into effect,” the lawmakers said in closing their letter. “This approach will give Congress sufficient time to develop a meaningful solution and to address these looming needs.”

Another option might be for CMS to preserve the budget-neutrality claim for the 2021 physician fee schedule but soften the blow on specialties, Brian Fortune, president of the consulting firm Farragut Square Group, told Medscape Medical News. A former staffer for Republican leadership in the House of Representatives, Fortune has for more than 20 years followed Medicare policy.

The agency could redo some of the assumptions used in estimating the offsets, he said, adding that in the draft rule, CMS appears to be seeking feedback that could help it with new calculations.

“CMS has been looking for a way out,” Fortune said. “CMS could remodel the assumptions, and the cuts could drop by half or more.

“The agency has several options to get creative as the need arises,” he said.

“Overvalued” vs “devalued”

In its comment to CMS, though, MedPAC argued strongly for maintaining the offsets. The commission has for several years been investigating ways to use Medicare’s payment policies as a tool to boost the ranks of clinicians who provide primary care.

A reshuffling of payments among specialties is needed to address a known imbalance in which Medicare for many years has “overvalued” procedures at the expense of other medical care, wrote Michael E. Chernew, PhD, the chairman of MedPAC, in an October 2 comment to CMS.

“Some types of services — such as procedures, imaging, and tests — experience efficiency gains over time, as advances in technology, technique, and clinical practice enable clinicians to deliver them faster,” he wrote. “However, E&M office/outpatient visits do not lend themselves to such efficiency gains because they consist largely of activities that require the clinician’s time.”

Medicare’s payment policies have thus “passively devalued” the time many clinicians spend on office visits, helping to skew the decisions of young physicians toward specialties, according to Chernew.

Reshuffling payment away from specialties that are now “overvalued” is needed to “remedy several years of passive devaluation,” he wrote.

The median income in 2018 for primary care physicians was $243,000 in 2018, whereas that of specialists such as surgeons was $426,000, Chernew said in the letter, citing MedPAC research.

These figures echo the findings of Medscape’s most recent annual physician compensation report.

As one of the largest buyers of medical services, Medicare has significant influence on the practice of medicine in the United States. In 2018 alone, Medicare directly paid $70.5 billion for clinician services. Its payment policies already may have shaped the pool of clinicians available to treat people enrolled in Medicare, which covers those aged 65 years and older, Chernew said.

“The US has over three times as many specialists as primary care physicians, which could explain why MedPAC’s annual survey of Medicare beneficiaries has repeatedly found that beneficiaries who are looking for a new physician report having an easier time finding a new specialist than a new primary care provider,” he wrote.

“Access to primary care physicians could worsen in the future as the number of primary care physicians in the US, after remaining flat for several years, has actually started to decline,” Chernew said.

This article first appeared on Medscape.com.

Medicare officials must soon decide whether to kick off next year with a shift of money away from specialties centered around procedures and toward primary care and other fields more focused on office visits.

A planned overhaul of reimbursement for evaluation and management (E/M) services emerged as perhaps the most contentious issue connected to Medicare’s 2021 payment policies for clinicians.

roobcio/Thinkstock

The Centers for Medicare & Medicaid Services (CMS) included the planned E/M overhaul — and accompanying offsets — in the draft 2021 physician fee schedule, released in August. The draft fee schedule drew at least 45,675 responses by October 5, the deadline for offering comments, with many of the responses addressing the E/M overhaul.

The influential Medicare Payment Advisory Commission (MedPAC) “strongly” endorsed the “budget-neutral” approach taken with the E/M overhaul. This planned reshuffling of payments is a step toward addressing a shortfall of primary care clinicians, inasmuch as it would help make this field more financially appealing, MedPAC said in an October 2 letter to CMS.

In contrast, physician organizations, including the American Medical Association (AMA), asked CMS to waive or revise the budget-neutral aspect of the E/M overhaul. Among the specialties slated for reductions are those deeply involved with the response to the pandemic, wrote James L. Madara, AMA’s chief executive officer, in an October 5 comment to CMS. Emergency medicine as a field would see a 6% cut, and infectious disease specialists, a 4% reduction.

“Payment reductions of this magnitude would be a major problem at any time, but to impose cuts of this magnitude during or immediately after the COVID-19 pandemic, including steep cuts to many of the specialties that have been on the front lines in efforts to treat patients in places with widespread infection, is unconscionable,” Madara wrote.

Madara also said specialties scheduled for payment reductions include those least able to make up for the lack of in-person care as a result of the uptick in telehealth during the pandemic.

A chart in the draft physician fee schedule (Table 90) shows reductions for many specialties that do not routinely bill for office visits. The table shows an 8% cut for anesthesiologists, a 7% cut for general surgeons, and a 6% cut for ophthalmologists. Table 90 also shows an estimated 11% reduction for radiologists and a 9% drop for pathologists.

The draft rule notes that these figures are based upon estimates of aggregate allowed charges across all services, so they may not reflect what any particular clinician might receive.

In total, Table 90 shows how the E/M changes and connected offsets would affect more than 50 fields of medicine. The proposal includes a 17% expected increase for endocrinologists and a 14% bump for those in hematology/oncology. There are expected increases of 13% for family practice and 4% for internal medicine.

This reshuffling of payments among specialties is only part of the 2021 E/M overhaul. There’s strong support for other aspects, making it unlikely that CMS would consider dropping the plan entirely.

“CMS’ new office visit policy will lead to significant administrative burden reduction and will better describe and recognize the resources involved in clinical office visits as they are performed today,” AMA’s Madara wrote in his comment.

Changes for the billing framework for E/M slated to start in 2021 are the result of substantial collaboration by an AMA-convened work group, which brought together more than 170 state medical and specialty societies, Madara said in his comment.

CMS has been developing this plan for several years. It outlined this 2021 E/M overhaul in the 2020 Medicare physician fee schedule finalized last year.

Madara urged CMS to proceed with the E/M changes but also “exercise the full breadth and depth of its administrative authority” to avoid or minimize the planned cuts.

“To be clear, we are not asking CMS to phase in implementation of the E/M changes but rather to phase in the payment reductions for certain specialties and health professionals in 2021 due to budget neutrality,” he wrote.

Other groups asking CMS to waive the budget-neutrality requirement include the American College of Physicians, the American College of Emergency Physicians, the American Society for Radiation Oncology, and the American Society of Neuroradiology.

The American Academy of Family Physicians (AAFP) asked CMS to temporarily waive the budget-neutrality requirement and pressed the agency to maintain the underlying principle of the E/M overhaul.

“Should HHS [Department of Health and Human Services] use its authority to waive budget neutrality, we also recommend that CMS finalize a reinstatement plan for the conversion factor reductions that provides physician practices with ample time to prepare and does not result in a financial cliff,” wrote John S. Cullen, MD, board chair for AAFP, in a September 28 comment to CMS.

Owing to the declaration of a public health emergency, HHS could use a special provision known as 1135 waiver authority to waive budget-neutrality requirements, Cullen wrote.

“The AAFP understands that HHS’ authority is limited by the timing of the end of the public health emergency, but we believe that this approach will provide Congress with needed time to enact an accompanying legislative solution,” he wrote.
 

Lawmakers weigh in

Lawmakers in both political parties have asked CMS to reconsider the offsets in the E/M overhaul.

Rep. Michael C. Burgess, MD (R-TX), who practiced as an obstetrician before joining Congress, in October introduced a bill with Rep. Bobby Rush (D-IL) that would provide for a 1-year waiver of budget-neutrality adjustments under the Medicare physician fee schedule.

Burgess and Rush were among the more than 160 members of Congress who signed a September letter to CMS asking the agency to act on its own to drop the budget-neutrality requirement. In the letter, led by Rep. Roger Marshall, MD (R-KS), the lawmakers acknowledge the usual legal requirements for CMS to offset payment increases in the physician fee schedule with cuts. But the lawmakers said the national public health emergency allows CMS to work around this.

“Given the effects of the COVID-19 pandemic, we believe you have the regulatory authority to immediately address these inequities,” the lawmakers wrote. “There is also the need to consider how the outbreak will be in the fall/winter months and if postponing certain elective procedures will go back into effect, per CMS’ recommendations.

“While we understand that legislative action may also be required to address this issue, given the January 1, 2021 effective date, we would ask you to take immediate actions to delay or mitigate these cuts while allowing the scheduled increases to go into effect,” the lawmakers said in closing their letter. “This approach will give Congress sufficient time to develop a meaningful solution and to address these looming needs.”

Another option might be for CMS to preserve the budget-neutrality claim for the 2021 physician fee schedule but soften the blow on specialties, Brian Fortune, president of the consulting firm Farragut Square Group, told Medscape Medical News. A former staffer for Republican leadership in the House of Representatives, Fortune has for more than 20 years followed Medicare policy.

The agency could redo some of the assumptions used in estimating the offsets, he said, adding that in the draft rule, CMS appears to be seeking feedback that could help it with new calculations.

“CMS has been looking for a way out,” Fortune said. “CMS could remodel the assumptions, and the cuts could drop by half or more.

“The agency has several options to get creative as the need arises,” he said.

“Overvalued” vs “devalued”

In its comment to CMS, though, MedPAC argued strongly for maintaining the offsets. The commission has for several years been investigating ways to use Medicare’s payment policies as a tool to boost the ranks of clinicians who provide primary care.

A reshuffling of payments among specialties is needed to address a known imbalance in which Medicare for many years has “overvalued” procedures at the expense of other medical care, wrote Michael E. Chernew, PhD, the chairman of MedPAC, in an October 2 comment to CMS.

“Some types of services — such as procedures, imaging, and tests — experience efficiency gains over time, as advances in technology, technique, and clinical practice enable clinicians to deliver them faster,” he wrote. “However, E&M office/outpatient visits do not lend themselves to such efficiency gains because they consist largely of activities that require the clinician’s time.”

Medicare’s payment policies have thus “passively devalued” the time many clinicians spend on office visits, helping to skew the decisions of young physicians toward specialties, according to Chernew.

Reshuffling payment away from specialties that are now “overvalued” is needed to “remedy several years of passive devaluation,” he wrote.

The median income in 2018 for primary care physicians was $243,000 in 2018, whereas that of specialists such as surgeons was $426,000, Chernew said in the letter, citing MedPAC research.

These figures echo the findings of Medscape’s most recent annual physician compensation report.

As one of the largest buyers of medical services, Medicare has significant influence on the practice of medicine in the United States. In 2018 alone, Medicare directly paid $70.5 billion for clinician services. Its payment policies already may have shaped the pool of clinicians available to treat people enrolled in Medicare, which covers those aged 65 years and older, Chernew said.

“The US has over three times as many specialists as primary care physicians, which could explain why MedPAC’s annual survey of Medicare beneficiaries has repeatedly found that beneficiaries who are looking for a new physician report having an easier time finding a new specialist than a new primary care provider,” he wrote.

“Access to primary care physicians could worsen in the future as the number of primary care physicians in the US, after remaining flat for several years, has actually started to decline,” Chernew said.

This article first appeared on Medscape.com.