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White House announces long-COVID action plan
The National Research Action Plan on Long COVID will gather experts from various agencies, including the Department of Defense and the Department of Veterans Affairs, to expand existing long-COVID clinics and broaden research on symptoms of the virus that persist long after infection.
“We’ll collaborate with academic, industry, state and local partners to better understand long COVID,” Health and Human Services Secretary Xavier Becerra said at a White House briefing April 5. “We need to work as aggressively as we can to make sure no American is left behind.”
The plan will build on the RECOVER Initiative, a $1.15 billion effort announced last year that will study long COVID.
The COVID-19 Response Team also announced that the United States will donate tens of millions of pediatric coronavirus vaccines to other countries. More than 20 countries have asked for the donations, the team said.
The United States has delivered more than 500 million vaccine doses to 114 countries.
Meanwhile, national COVID-19 numbers continue to fall. CDC Director Rochelle Walensky, MD, reported that average daily cases are down 4% this week to 25,000; hospitalizations have dropped 17% to 1,400 per day; and daily deaths are down to 570 a day, which is a decrease of about 17%.
New national estimates show that Omicron’s subvariant BA.2 now accounts for 72% of circulating variants nationally, she said.
Top infectious disease expert Anthony Fauci, MD, reported that recent data supports the need for a second booster among certain people 50 and older – a move authorized by the Food and Drug Administration and Centers for Disease Control and Prevention last week.
“The effectiveness of the first booster dose we know wanes over time, and growing evidence shows a second dose can restore vaccine effectiveness for certain populations,” he said.
Dr. Fauci reported findings from an Israeli study of more than 1 million people 60 and older, which showed that an additional booster dose after 4 months lowered the rate of infection by two times and lowered the rate of severe infection by more than four times.
Another study from Israeli scientists showed that out of half a million people 60 and older, a second booster after 4 months brought a 78% reduction in death, compared to those who received only the first boost.
A version of this article first appeared on WebMD.com.
The National Research Action Plan on Long COVID will gather experts from various agencies, including the Department of Defense and the Department of Veterans Affairs, to expand existing long-COVID clinics and broaden research on symptoms of the virus that persist long after infection.
“We’ll collaborate with academic, industry, state and local partners to better understand long COVID,” Health and Human Services Secretary Xavier Becerra said at a White House briefing April 5. “We need to work as aggressively as we can to make sure no American is left behind.”
The plan will build on the RECOVER Initiative, a $1.15 billion effort announced last year that will study long COVID.
The COVID-19 Response Team also announced that the United States will donate tens of millions of pediatric coronavirus vaccines to other countries. More than 20 countries have asked for the donations, the team said.
The United States has delivered more than 500 million vaccine doses to 114 countries.
Meanwhile, national COVID-19 numbers continue to fall. CDC Director Rochelle Walensky, MD, reported that average daily cases are down 4% this week to 25,000; hospitalizations have dropped 17% to 1,400 per day; and daily deaths are down to 570 a day, which is a decrease of about 17%.
New national estimates show that Omicron’s subvariant BA.2 now accounts for 72% of circulating variants nationally, she said.
Top infectious disease expert Anthony Fauci, MD, reported that recent data supports the need for a second booster among certain people 50 and older – a move authorized by the Food and Drug Administration and Centers for Disease Control and Prevention last week.
“The effectiveness of the first booster dose we know wanes over time, and growing evidence shows a second dose can restore vaccine effectiveness for certain populations,” he said.
Dr. Fauci reported findings from an Israeli study of more than 1 million people 60 and older, which showed that an additional booster dose after 4 months lowered the rate of infection by two times and lowered the rate of severe infection by more than four times.
Another study from Israeli scientists showed that out of half a million people 60 and older, a second booster after 4 months brought a 78% reduction in death, compared to those who received only the first boost.
A version of this article first appeared on WebMD.com.
The National Research Action Plan on Long COVID will gather experts from various agencies, including the Department of Defense and the Department of Veterans Affairs, to expand existing long-COVID clinics and broaden research on symptoms of the virus that persist long after infection.
“We’ll collaborate with academic, industry, state and local partners to better understand long COVID,” Health and Human Services Secretary Xavier Becerra said at a White House briefing April 5. “We need to work as aggressively as we can to make sure no American is left behind.”
The plan will build on the RECOVER Initiative, a $1.15 billion effort announced last year that will study long COVID.
The COVID-19 Response Team also announced that the United States will donate tens of millions of pediatric coronavirus vaccines to other countries. More than 20 countries have asked for the donations, the team said.
The United States has delivered more than 500 million vaccine doses to 114 countries.
Meanwhile, national COVID-19 numbers continue to fall. CDC Director Rochelle Walensky, MD, reported that average daily cases are down 4% this week to 25,000; hospitalizations have dropped 17% to 1,400 per day; and daily deaths are down to 570 a day, which is a decrease of about 17%.
New national estimates show that Omicron’s subvariant BA.2 now accounts for 72% of circulating variants nationally, she said.
Top infectious disease expert Anthony Fauci, MD, reported that recent data supports the need for a second booster among certain people 50 and older – a move authorized by the Food and Drug Administration and Centers for Disease Control and Prevention last week.
“The effectiveness of the first booster dose we know wanes over time, and growing evidence shows a second dose can restore vaccine effectiveness for certain populations,” he said.
Dr. Fauci reported findings from an Israeli study of more than 1 million people 60 and older, which showed that an additional booster dose after 4 months lowered the rate of infection by two times and lowered the rate of severe infection by more than four times.
Another study from Israeli scientists showed that out of half a million people 60 and older, a second booster after 4 months brought a 78% reduction in death, compared to those who received only the first boost.
A version of this article first appeared on WebMD.com.
Performance anxiety highly common among surgeons
a new study of surgeons in the United Kingdom shows.
“Performance anxiety or stage fright is a widely recognized problem in music and sports, and there are many similarities between these arenas and the operating theater,” first author Robert Miller, MRCS, of the Surgical Psychology and Performance Group and the department of plastic and reconstructive surgery at St. George’s Hospital NHS Trust, London, said in an interview. “We were aware of it anecdotally in a surgical context, but for one reason or another, perhaps professional pride and fear of negative perception, this is rarely openly discussed amongst surgeons.”
In the cross-sectional study, published in Annals of Surgery, Dr. Miller and colleagues surveyed surgeons in all specialties working in the United Kingdom who had at least 1 year of postgraduate surgical training.
Of a total of 631 responses received, 523 (83%) were included in the analysis. The median age of those who responded was 41.2 years, and the mean duration of surgical experience was 15.3 years (range, 1-52 years). Among them, 62% were men, and 52% were of consultant/attending grade.
All of the respondents – 100% – said they believed that performance anxiety affected surgeons, 87% reported having experienced it themselves, and 65% said they felt that performance anxiety had an effect on their surgical performance.
Both male and female surgeons who reported experiencing performance anxiety had significantly worse mental well-being, as assessed using the Short Warwick Edinburgh Mental Wellbeing Scale, compared with those who did not have performance anxiety (P < .0001 for men and P < .001 for women).
Overall, however, male surgeons had significantly better mental well-being, compared with female surgeons (P = .003), yet both genders had significantly lower mental well-being scores compared with U.K. population norms (P = .0019 for men and P = .0001 for women).
The gender differences are “clearly an important topic, which is likely multifactorial,” Dr. Miller told this news organization. “The gender well-being gap requires more in-depth research, and qualitative work involving female surgeons is critical.”
Surgical perfectionism was significantly more common among respondents who did have performance anxiety in comparison with those who did not (P < .0001).
“Although perfectionism may be a beneficial trait in surgery, our findings from hierarchical multiple regression analysis also indicate that perfectionism, [as well as] sex and experience, may drive surgical performance anxiety and help predict those experiencing [the anxiety],” the authors noted.
Performing in presence of colleagues a key trigger
By far, the leading trigger that was identified as prompting surgeon performance anxiety was the presence – and scrutiny – of colleagues within the parent specialty. This was reported by 151 respondents. Other triggers were having to perform on highly complex or high-risk cases (66 responses) and a lack of experience (30 responses).
Next to planning and preparation, opening up and talking about the anxiety and shedding light on the issue was seen as a leading strategy to help with the problem, but very few respondents reported openly sharing their struggles. Only 9% reported that they had shared it openly; 27% said they had confided in someone, and 47% did not respond to the question.
“I wish we talked about it more and shared our insecurities,” one respondent lamented. “Most of my colleagues pretend they are living gods.”
Only about 45% of respondents reported a specific technique for overcoming their anxiety. In addition to being open about the problem, other techniques included self-care, such as exercise; and distraction outside of work to get perspective; relaxation techniques such as deep or controlled breathing; music; mindfulness; and positive self-statements.
About 9% said they had received psychological counseling for performance anxiety, and only 3% reported using medication for the problem.
Anxiety a positive factor?
Surprisingly, 70% of respondents reported feeling that surgical performance anxiety could have a positive impact on surgical performance, which the authors noted is consistent with some theories.
“This may be explained by the traditional bell-curve relationship between arousal and performance, which describes a dose-dependent relationship between performance and arousal until a ‘tipping point,’ after which performance declines,” the authors explained. “A heightened awareness secondary to anxiety may be beneficial, but at high doses, anxiety can negatively affect attentional control and cause somatic symptoms.”
They noted that “the challenge would be to reap the benefits of low-level stimulation without incurring possible adverse effects.”
Dr. Miller said that, in determining whether selection bias had a role in the results, a detailed analysis showed that “our respondents were not skewed to those with only high levels of trait anxiety.
“We also had a good spread of consultants versus trainees [about half and half], and different specialties, so we feel this is likely to be a representative sample,” he told this news organization.
That being said, the results underscore the need for increased awareness – and open discussion – of the issue of surgical performance anxiety.
“Within other professions, particularly the performing arts and sports, performance psychology is becoming an integral part of training and development,” Dr. Miller said. “We feel surgeons should be supported in a similar manner.
“Surgical performance anxiety is normal for surgeons at all levels and not something to be ashamed about,” Dr. Miller added. “Talk about it, acknowledge it, and be supportive to your colleagues.”
Many keep it to themselves in ‘prevailing culture of stoicism’
Commenting on the study, Carter C. Lebares, MD, an associate professor of surgery and director of the Center for Mindfulness in Surgery, department of surgery, University of California, San Francisco, said she was not surprised to see the high rates of performance anxiety among surgeons.
“As surgeons, no matter how hard we train or how thoroughly we prepare our intellectual understanding or the patient, the disease process, and the operation, there may be surprises, unforeseen challenges, or off days,” Dr. Lebares said.
“And whatever we encounter, we are managing these things directly under the scrutiny of others – people who can affect our reputation, operating privileges, and mental health. So, I am not surprised this is a prevalent and widely recognized issue.”
Dr. Lebares noted that the reluctance to share the anxiety is part of a “challenging and recognized conundrum in both medicine and surgery and is a matter of the prevailing culture of stoicism.
“We often are called to shoulder tremendous weight intraoperatively (having perseverance, self-confidence, or sustained focus), and in owning the weight of complications (which eventually we all will have),” she said.
“So, we do need to be strong and not complain, [but] we also need to be able to set that aside [when appropriate] and ask for help or allow others to shoulder the weight for a while, and this is not [yet] a common part of surgical culture.”
Dr. Lebares added that randomized, controlled trials have shown benefits of mindfulness interventions on burnout and anxiety.
“We have observed positive effects on mental noise, self-perception, conflict resolution, and resilience in surgical residents trained in mindfulness-based cognitive skills,” she said. “[Residents] report applying these skills in the OR, in their home lives, and in how they approach their training/education.”
The authors disclosed no relevant financial relationships. Dr. Lebares has developed mindfulness-based cognitive skills training for surgeons but receives no financial compensation for the activities.
A version of this article first appeared on Medscape.com.
a new study of surgeons in the United Kingdom shows.
“Performance anxiety or stage fright is a widely recognized problem in music and sports, and there are many similarities between these arenas and the operating theater,” first author Robert Miller, MRCS, of the Surgical Psychology and Performance Group and the department of plastic and reconstructive surgery at St. George’s Hospital NHS Trust, London, said in an interview. “We were aware of it anecdotally in a surgical context, but for one reason or another, perhaps professional pride and fear of negative perception, this is rarely openly discussed amongst surgeons.”
In the cross-sectional study, published in Annals of Surgery, Dr. Miller and colleagues surveyed surgeons in all specialties working in the United Kingdom who had at least 1 year of postgraduate surgical training.
Of a total of 631 responses received, 523 (83%) were included in the analysis. The median age of those who responded was 41.2 years, and the mean duration of surgical experience was 15.3 years (range, 1-52 years). Among them, 62% were men, and 52% were of consultant/attending grade.
All of the respondents – 100% – said they believed that performance anxiety affected surgeons, 87% reported having experienced it themselves, and 65% said they felt that performance anxiety had an effect on their surgical performance.
Both male and female surgeons who reported experiencing performance anxiety had significantly worse mental well-being, as assessed using the Short Warwick Edinburgh Mental Wellbeing Scale, compared with those who did not have performance anxiety (P < .0001 for men and P < .001 for women).
Overall, however, male surgeons had significantly better mental well-being, compared with female surgeons (P = .003), yet both genders had significantly lower mental well-being scores compared with U.K. population norms (P = .0019 for men and P = .0001 for women).
The gender differences are “clearly an important topic, which is likely multifactorial,” Dr. Miller told this news organization. “The gender well-being gap requires more in-depth research, and qualitative work involving female surgeons is critical.”
Surgical perfectionism was significantly more common among respondents who did have performance anxiety in comparison with those who did not (P < .0001).
“Although perfectionism may be a beneficial trait in surgery, our findings from hierarchical multiple regression analysis also indicate that perfectionism, [as well as] sex and experience, may drive surgical performance anxiety and help predict those experiencing [the anxiety],” the authors noted.
Performing in presence of colleagues a key trigger
By far, the leading trigger that was identified as prompting surgeon performance anxiety was the presence – and scrutiny – of colleagues within the parent specialty. This was reported by 151 respondents. Other triggers were having to perform on highly complex or high-risk cases (66 responses) and a lack of experience (30 responses).
Next to planning and preparation, opening up and talking about the anxiety and shedding light on the issue was seen as a leading strategy to help with the problem, but very few respondents reported openly sharing their struggles. Only 9% reported that they had shared it openly; 27% said they had confided in someone, and 47% did not respond to the question.
“I wish we talked about it more and shared our insecurities,” one respondent lamented. “Most of my colleagues pretend they are living gods.”
Only about 45% of respondents reported a specific technique for overcoming their anxiety. In addition to being open about the problem, other techniques included self-care, such as exercise; and distraction outside of work to get perspective; relaxation techniques such as deep or controlled breathing; music; mindfulness; and positive self-statements.
About 9% said they had received psychological counseling for performance anxiety, and only 3% reported using medication for the problem.
Anxiety a positive factor?
Surprisingly, 70% of respondents reported feeling that surgical performance anxiety could have a positive impact on surgical performance, which the authors noted is consistent with some theories.
“This may be explained by the traditional bell-curve relationship between arousal and performance, which describes a dose-dependent relationship between performance and arousal until a ‘tipping point,’ after which performance declines,” the authors explained. “A heightened awareness secondary to anxiety may be beneficial, but at high doses, anxiety can negatively affect attentional control and cause somatic symptoms.”
They noted that “the challenge would be to reap the benefits of low-level stimulation without incurring possible adverse effects.”
Dr. Miller said that, in determining whether selection bias had a role in the results, a detailed analysis showed that “our respondents were not skewed to those with only high levels of trait anxiety.
“We also had a good spread of consultants versus trainees [about half and half], and different specialties, so we feel this is likely to be a representative sample,” he told this news organization.
That being said, the results underscore the need for increased awareness – and open discussion – of the issue of surgical performance anxiety.
“Within other professions, particularly the performing arts and sports, performance psychology is becoming an integral part of training and development,” Dr. Miller said. “We feel surgeons should be supported in a similar manner.
“Surgical performance anxiety is normal for surgeons at all levels and not something to be ashamed about,” Dr. Miller added. “Talk about it, acknowledge it, and be supportive to your colleagues.”
Many keep it to themselves in ‘prevailing culture of stoicism’
Commenting on the study, Carter C. Lebares, MD, an associate professor of surgery and director of the Center for Mindfulness in Surgery, department of surgery, University of California, San Francisco, said she was not surprised to see the high rates of performance anxiety among surgeons.
“As surgeons, no matter how hard we train or how thoroughly we prepare our intellectual understanding or the patient, the disease process, and the operation, there may be surprises, unforeseen challenges, or off days,” Dr. Lebares said.
“And whatever we encounter, we are managing these things directly under the scrutiny of others – people who can affect our reputation, operating privileges, and mental health. So, I am not surprised this is a prevalent and widely recognized issue.”
Dr. Lebares noted that the reluctance to share the anxiety is part of a “challenging and recognized conundrum in both medicine and surgery and is a matter of the prevailing culture of stoicism.
“We often are called to shoulder tremendous weight intraoperatively (having perseverance, self-confidence, or sustained focus), and in owning the weight of complications (which eventually we all will have),” she said.
“So, we do need to be strong and not complain, [but] we also need to be able to set that aside [when appropriate] and ask for help or allow others to shoulder the weight for a while, and this is not [yet] a common part of surgical culture.”
Dr. Lebares added that randomized, controlled trials have shown benefits of mindfulness interventions on burnout and anxiety.
“We have observed positive effects on mental noise, self-perception, conflict resolution, and resilience in surgical residents trained in mindfulness-based cognitive skills,” she said. “[Residents] report applying these skills in the OR, in their home lives, and in how they approach their training/education.”
The authors disclosed no relevant financial relationships. Dr. Lebares has developed mindfulness-based cognitive skills training for surgeons but receives no financial compensation for the activities.
A version of this article first appeared on Medscape.com.
a new study of surgeons in the United Kingdom shows.
“Performance anxiety or stage fright is a widely recognized problem in music and sports, and there are many similarities between these arenas and the operating theater,” first author Robert Miller, MRCS, of the Surgical Psychology and Performance Group and the department of plastic and reconstructive surgery at St. George’s Hospital NHS Trust, London, said in an interview. “We were aware of it anecdotally in a surgical context, but for one reason or another, perhaps professional pride and fear of negative perception, this is rarely openly discussed amongst surgeons.”
In the cross-sectional study, published in Annals of Surgery, Dr. Miller and colleagues surveyed surgeons in all specialties working in the United Kingdom who had at least 1 year of postgraduate surgical training.
Of a total of 631 responses received, 523 (83%) were included in the analysis. The median age of those who responded was 41.2 years, and the mean duration of surgical experience was 15.3 years (range, 1-52 years). Among them, 62% were men, and 52% were of consultant/attending grade.
All of the respondents – 100% – said they believed that performance anxiety affected surgeons, 87% reported having experienced it themselves, and 65% said they felt that performance anxiety had an effect on their surgical performance.
Both male and female surgeons who reported experiencing performance anxiety had significantly worse mental well-being, as assessed using the Short Warwick Edinburgh Mental Wellbeing Scale, compared with those who did not have performance anxiety (P < .0001 for men and P < .001 for women).
Overall, however, male surgeons had significantly better mental well-being, compared with female surgeons (P = .003), yet both genders had significantly lower mental well-being scores compared with U.K. population norms (P = .0019 for men and P = .0001 for women).
The gender differences are “clearly an important topic, which is likely multifactorial,” Dr. Miller told this news organization. “The gender well-being gap requires more in-depth research, and qualitative work involving female surgeons is critical.”
Surgical perfectionism was significantly more common among respondents who did have performance anxiety in comparison with those who did not (P < .0001).
“Although perfectionism may be a beneficial trait in surgery, our findings from hierarchical multiple regression analysis also indicate that perfectionism, [as well as] sex and experience, may drive surgical performance anxiety and help predict those experiencing [the anxiety],” the authors noted.
Performing in presence of colleagues a key trigger
By far, the leading trigger that was identified as prompting surgeon performance anxiety was the presence – and scrutiny – of colleagues within the parent specialty. This was reported by 151 respondents. Other triggers were having to perform on highly complex or high-risk cases (66 responses) and a lack of experience (30 responses).
Next to planning and preparation, opening up and talking about the anxiety and shedding light on the issue was seen as a leading strategy to help with the problem, but very few respondents reported openly sharing their struggles. Only 9% reported that they had shared it openly; 27% said they had confided in someone, and 47% did not respond to the question.
“I wish we talked about it more and shared our insecurities,” one respondent lamented. “Most of my colleagues pretend they are living gods.”
Only about 45% of respondents reported a specific technique for overcoming their anxiety. In addition to being open about the problem, other techniques included self-care, such as exercise; and distraction outside of work to get perspective; relaxation techniques such as deep or controlled breathing; music; mindfulness; and positive self-statements.
About 9% said they had received psychological counseling for performance anxiety, and only 3% reported using medication for the problem.
Anxiety a positive factor?
Surprisingly, 70% of respondents reported feeling that surgical performance anxiety could have a positive impact on surgical performance, which the authors noted is consistent with some theories.
“This may be explained by the traditional bell-curve relationship between arousal and performance, which describes a dose-dependent relationship between performance and arousal until a ‘tipping point,’ after which performance declines,” the authors explained. “A heightened awareness secondary to anxiety may be beneficial, but at high doses, anxiety can negatively affect attentional control and cause somatic symptoms.”
They noted that “the challenge would be to reap the benefits of low-level stimulation without incurring possible adverse effects.”
Dr. Miller said that, in determining whether selection bias had a role in the results, a detailed analysis showed that “our respondents were not skewed to those with only high levels of trait anxiety.
“We also had a good spread of consultants versus trainees [about half and half], and different specialties, so we feel this is likely to be a representative sample,” he told this news organization.
That being said, the results underscore the need for increased awareness – and open discussion – of the issue of surgical performance anxiety.
“Within other professions, particularly the performing arts and sports, performance psychology is becoming an integral part of training and development,” Dr. Miller said. “We feel surgeons should be supported in a similar manner.
“Surgical performance anxiety is normal for surgeons at all levels and not something to be ashamed about,” Dr. Miller added. “Talk about it, acknowledge it, and be supportive to your colleagues.”
Many keep it to themselves in ‘prevailing culture of stoicism’
Commenting on the study, Carter C. Lebares, MD, an associate professor of surgery and director of the Center for Mindfulness in Surgery, department of surgery, University of California, San Francisco, said she was not surprised to see the high rates of performance anxiety among surgeons.
“As surgeons, no matter how hard we train or how thoroughly we prepare our intellectual understanding or the patient, the disease process, and the operation, there may be surprises, unforeseen challenges, or off days,” Dr. Lebares said.
“And whatever we encounter, we are managing these things directly under the scrutiny of others – people who can affect our reputation, operating privileges, and mental health. So, I am not surprised this is a prevalent and widely recognized issue.”
Dr. Lebares noted that the reluctance to share the anxiety is part of a “challenging and recognized conundrum in both medicine and surgery and is a matter of the prevailing culture of stoicism.
“We often are called to shoulder tremendous weight intraoperatively (having perseverance, self-confidence, or sustained focus), and in owning the weight of complications (which eventually we all will have),” she said.
“So, we do need to be strong and not complain, [but] we also need to be able to set that aside [when appropriate] and ask for help or allow others to shoulder the weight for a while, and this is not [yet] a common part of surgical culture.”
Dr. Lebares added that randomized, controlled trials have shown benefits of mindfulness interventions on burnout and anxiety.
“We have observed positive effects on mental noise, self-perception, conflict resolution, and resilience in surgical residents trained in mindfulness-based cognitive skills,” she said. “[Residents] report applying these skills in the OR, in their home lives, and in how they approach their training/education.”
The authors disclosed no relevant financial relationships. Dr. Lebares has developed mindfulness-based cognitive skills training for surgeons but receives no financial compensation for the activities.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF SURGERY
New COVID combo-variant XE found in U.K.
As of last week, the U.K. Health Security Agency had found 637 cases of the variant, known as XE. The earliest case was found Jan. 19.
The new strain is known as a recombinant, which means it is a combination of two variants or viruses.
XE makes up less than 1% of sequenced cases in the United Kingdom so far, and there is no evidence yet that the strain leads to more severe disease or less vaccine protection.
“Right now, there’s really no public health concern,” John Brownstein, PhD, an epidemiologist and chief innovation officer at Boston Children’s Hospital, told ABC. “Recombinant variants happen over and over. In fact, the reason that this is the XE variant recombinant is that we’ve had XA, XB, XC, XD already, and none of those have turned out to be any real concern.”
A World Health Organization update published March 29 notes XE’s high transmissibility and says it may have a growth advantage of 10% over the BA.2 subvariant that now makes up more than 70% of cases in the United States.
A version of this article first appeared on WebMD.com.
As of last week, the U.K. Health Security Agency had found 637 cases of the variant, known as XE. The earliest case was found Jan. 19.
The new strain is known as a recombinant, which means it is a combination of two variants or viruses.
XE makes up less than 1% of sequenced cases in the United Kingdom so far, and there is no evidence yet that the strain leads to more severe disease or less vaccine protection.
“Right now, there’s really no public health concern,” John Brownstein, PhD, an epidemiologist and chief innovation officer at Boston Children’s Hospital, told ABC. “Recombinant variants happen over and over. In fact, the reason that this is the XE variant recombinant is that we’ve had XA, XB, XC, XD already, and none of those have turned out to be any real concern.”
A World Health Organization update published March 29 notes XE’s high transmissibility and says it may have a growth advantage of 10% over the BA.2 subvariant that now makes up more than 70% of cases in the United States.
A version of this article first appeared on WebMD.com.
As of last week, the U.K. Health Security Agency had found 637 cases of the variant, known as XE. The earliest case was found Jan. 19.
The new strain is known as a recombinant, which means it is a combination of two variants or viruses.
XE makes up less than 1% of sequenced cases in the United Kingdom so far, and there is no evidence yet that the strain leads to more severe disease or less vaccine protection.
“Right now, there’s really no public health concern,” John Brownstein, PhD, an epidemiologist and chief innovation officer at Boston Children’s Hospital, told ABC. “Recombinant variants happen over and over. In fact, the reason that this is the XE variant recombinant is that we’ve had XA, XB, XC, XD already, and none of those have turned out to be any real concern.”
A World Health Organization update published March 29 notes XE’s high transmissibility and says it may have a growth advantage of 10% over the BA.2 subvariant that now makes up more than 70% of cases in the United States.
A version of this article first appeared on WebMD.com.
On the receiving end of care
It’s tough being on the receiving end of care. I’ve tried to avoid it as much as possible, being ever mindful of the law from Samuel Shem’s The House of God: “They can always hurt you more.”
Fortunately, each procedure went more smoothly than the prior one.
The first was not so elective. I had some uncomfortable symptoms while exercising and, not wanting to totally be in denial, contacted my doctor to ensure that it was not cardiac in origin since symptoms are often atypical in women.
My physician promptly saw me, then scheduled a nuclear stress test. There was a series of needless glitches. Registration at the diagnostic center had me on their schedule but did not have an order. They would have canceled the procedure had I not been able to get hold of the doctor’s office. Why isn’t an order automatically entered when the physician schedules the test?
While I was given the euphemistic “Patient Rights” brochure, asking to have reports sent to a physician outside of the University of Pittsburgh Medical Center empire is apparently not included.
The staff canceled the stress test because I was not fasting. I had received no instructions from diagnostic cardiology. They suggested it was my internist’s responsibility.
I deliberately ate (2 hours earlier) because my trainer always wants me to eat a light meal so I don’t get hypoglycemic during our workouts, and an exercise stress test, is, of course, a workout. The nurse practitioner said that they were concerned I would vomit. I offered to sign a waiver. She parried, saying they would not be able to get adequate images, so I was out of luck.
When I expressed concern about getting hypoglycemic and having difficulty with the test if fasting, the tech said I should bring a soda and snack. Who tells a “borderline” diabetic to bring a soda?
The tech also said she had called our home to give instructions but encountered a busy signal and had not had time to call back. I had not left the house during the prior week (or most of the past 2 years), so this was a pretty lame excuse.
I suggested to the administration that the hospital offer to email the patient instructions well ahead of time (and perhaps ask for confirmation of receipt). If calling, they should try more than once. They should also have patient instruction sheets at the physician’s office and perhaps have them on their website.
It turns out that the hospital mailed me instructions, not on the date it was ordered, but with the postmark being the day of the procedure itself. With Trump donor Louis DeJoy in charge of the U.S. Postal Service, mail across town now has to travel to Baltimore, 3 hours away, be sorted, and returned.
I did finally have the stress test, which was reassuringly normal. I was not surprised, given that the fury I felt on the first attempt had not precipitated symptoms. The hospital sent a patient ombudsman to meet me there to discuss my previous complaints. I have no idea if they implemented any of the changes I had suggested. In 2021, when I urgently had to take my husband to the ED, I couldn’t see the sign pointing toward the ED and had to ask for directions at the main entrance. They said they would fix that promptly but still have not improved the signage. How I miss the friendly community hospital we had before!
Next was trigger-finger surgery. I had developed that in 1978 from using crutches after a fall. I figured that the relative lull in COVID and my activities made it as good a time as any to finally have it fixed. The surgicenter was great; the surgeon was someone I had worked with and respected for decades. The only glitch was not really knowing how long I was going to be out of commission.
The third encounter (at yet another institution) went really well, despite some early administrative glitches. My major complaint was with the lack of communication between preoperative anesthesia and the operating room and the lack of personalization of preoperative instructions. Despite EPIC, medicines were not correctly reconciled between the different encounters, even on the same day!
After about 15 years of diplopia, which has been gradually worsening, my eye doc had suggested that I consider strabismus surgery as a sort of last-ditch effort to improve my quality of life.
Anesthesiology has stock instructions, which they made no effort to individualize. For example, there is no reason to stop NSAIDs a week before such minor surgery. That’s a problem if you depend on NSAIDs for pain control. Similarly, nothing by mouth after midnight is passé and could be tailored for the patient. I felt particularly inconvenienced that I had to go out of town for the preoperative visit and then have a redundant preoperative clearance by my physician.
The nurses in the preoperative area made me feel quite comfortable and as relaxed as I could be under the circumstances. They had a good sense of humor, which helped too. And from the time I met him a few weeks earlier, I instantly liked my surgeon and felt very comfortable with him and had complete trust.
I was pleased that the chief anesthesiologist responded promptly and undefensively to my letter expressing concerns. I do believe that he will try to improve the systemic problems.
The best part: The surgery appears to have been successful and I should have a significantly improved quality of life.
Hospitals could do so much better by improving communications with patients and by viewing them as customers whose loyalty they must earn and will value. With monopolies growing, memories of such care are quickly fading, soon to be as extinct as the family doc who made house calls.
Dr. Stone is an infectious disease specialist and author of Resilience: One Family’s Story of Hope and Triumph over Evil and Conducting Clinical Research: A Practical Guide. She disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.
It’s tough being on the receiving end of care. I’ve tried to avoid it as much as possible, being ever mindful of the law from Samuel Shem’s The House of God: “They can always hurt you more.”
Fortunately, each procedure went more smoothly than the prior one.
The first was not so elective. I had some uncomfortable symptoms while exercising and, not wanting to totally be in denial, contacted my doctor to ensure that it was not cardiac in origin since symptoms are often atypical in women.
My physician promptly saw me, then scheduled a nuclear stress test. There was a series of needless glitches. Registration at the diagnostic center had me on their schedule but did not have an order. They would have canceled the procedure had I not been able to get hold of the doctor’s office. Why isn’t an order automatically entered when the physician schedules the test?
While I was given the euphemistic “Patient Rights” brochure, asking to have reports sent to a physician outside of the University of Pittsburgh Medical Center empire is apparently not included.
The staff canceled the stress test because I was not fasting. I had received no instructions from diagnostic cardiology. They suggested it was my internist’s responsibility.
I deliberately ate (2 hours earlier) because my trainer always wants me to eat a light meal so I don’t get hypoglycemic during our workouts, and an exercise stress test, is, of course, a workout. The nurse practitioner said that they were concerned I would vomit. I offered to sign a waiver. She parried, saying they would not be able to get adequate images, so I was out of luck.
When I expressed concern about getting hypoglycemic and having difficulty with the test if fasting, the tech said I should bring a soda and snack. Who tells a “borderline” diabetic to bring a soda?
The tech also said she had called our home to give instructions but encountered a busy signal and had not had time to call back. I had not left the house during the prior week (or most of the past 2 years), so this was a pretty lame excuse.
I suggested to the administration that the hospital offer to email the patient instructions well ahead of time (and perhaps ask for confirmation of receipt). If calling, they should try more than once. They should also have patient instruction sheets at the physician’s office and perhaps have them on their website.
It turns out that the hospital mailed me instructions, not on the date it was ordered, but with the postmark being the day of the procedure itself. With Trump donor Louis DeJoy in charge of the U.S. Postal Service, mail across town now has to travel to Baltimore, 3 hours away, be sorted, and returned.
I did finally have the stress test, which was reassuringly normal. I was not surprised, given that the fury I felt on the first attempt had not precipitated symptoms. The hospital sent a patient ombudsman to meet me there to discuss my previous complaints. I have no idea if they implemented any of the changes I had suggested. In 2021, when I urgently had to take my husband to the ED, I couldn’t see the sign pointing toward the ED and had to ask for directions at the main entrance. They said they would fix that promptly but still have not improved the signage. How I miss the friendly community hospital we had before!
Next was trigger-finger surgery. I had developed that in 1978 from using crutches after a fall. I figured that the relative lull in COVID and my activities made it as good a time as any to finally have it fixed. The surgicenter was great; the surgeon was someone I had worked with and respected for decades. The only glitch was not really knowing how long I was going to be out of commission.
The third encounter (at yet another institution) went really well, despite some early administrative glitches. My major complaint was with the lack of communication between preoperative anesthesia and the operating room and the lack of personalization of preoperative instructions. Despite EPIC, medicines were not correctly reconciled between the different encounters, even on the same day!
After about 15 years of diplopia, which has been gradually worsening, my eye doc had suggested that I consider strabismus surgery as a sort of last-ditch effort to improve my quality of life.
Anesthesiology has stock instructions, which they made no effort to individualize. For example, there is no reason to stop NSAIDs a week before such minor surgery. That’s a problem if you depend on NSAIDs for pain control. Similarly, nothing by mouth after midnight is passé and could be tailored for the patient. I felt particularly inconvenienced that I had to go out of town for the preoperative visit and then have a redundant preoperative clearance by my physician.
The nurses in the preoperative area made me feel quite comfortable and as relaxed as I could be under the circumstances. They had a good sense of humor, which helped too. And from the time I met him a few weeks earlier, I instantly liked my surgeon and felt very comfortable with him and had complete trust.
I was pleased that the chief anesthesiologist responded promptly and undefensively to my letter expressing concerns. I do believe that he will try to improve the systemic problems.
The best part: The surgery appears to have been successful and I should have a significantly improved quality of life.
Hospitals could do so much better by improving communications with patients and by viewing them as customers whose loyalty they must earn and will value. With monopolies growing, memories of such care are quickly fading, soon to be as extinct as the family doc who made house calls.
Dr. Stone is an infectious disease specialist and author of Resilience: One Family’s Story of Hope and Triumph over Evil and Conducting Clinical Research: A Practical Guide. She disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.
It’s tough being on the receiving end of care. I’ve tried to avoid it as much as possible, being ever mindful of the law from Samuel Shem’s The House of God: “They can always hurt you more.”
Fortunately, each procedure went more smoothly than the prior one.
The first was not so elective. I had some uncomfortable symptoms while exercising and, not wanting to totally be in denial, contacted my doctor to ensure that it was not cardiac in origin since symptoms are often atypical in women.
My physician promptly saw me, then scheduled a nuclear stress test. There was a series of needless glitches. Registration at the diagnostic center had me on their schedule but did not have an order. They would have canceled the procedure had I not been able to get hold of the doctor’s office. Why isn’t an order automatically entered when the physician schedules the test?
While I was given the euphemistic “Patient Rights” brochure, asking to have reports sent to a physician outside of the University of Pittsburgh Medical Center empire is apparently not included.
The staff canceled the stress test because I was not fasting. I had received no instructions from diagnostic cardiology. They suggested it was my internist’s responsibility.
I deliberately ate (2 hours earlier) because my trainer always wants me to eat a light meal so I don’t get hypoglycemic during our workouts, and an exercise stress test, is, of course, a workout. The nurse practitioner said that they were concerned I would vomit. I offered to sign a waiver. She parried, saying they would not be able to get adequate images, so I was out of luck.
When I expressed concern about getting hypoglycemic and having difficulty with the test if fasting, the tech said I should bring a soda and snack. Who tells a “borderline” diabetic to bring a soda?
The tech also said she had called our home to give instructions but encountered a busy signal and had not had time to call back. I had not left the house during the prior week (or most of the past 2 years), so this was a pretty lame excuse.
I suggested to the administration that the hospital offer to email the patient instructions well ahead of time (and perhaps ask for confirmation of receipt). If calling, they should try more than once. They should also have patient instruction sheets at the physician’s office and perhaps have them on their website.
It turns out that the hospital mailed me instructions, not on the date it was ordered, but with the postmark being the day of the procedure itself. With Trump donor Louis DeJoy in charge of the U.S. Postal Service, mail across town now has to travel to Baltimore, 3 hours away, be sorted, and returned.
I did finally have the stress test, which was reassuringly normal. I was not surprised, given that the fury I felt on the first attempt had not precipitated symptoms. The hospital sent a patient ombudsman to meet me there to discuss my previous complaints. I have no idea if they implemented any of the changes I had suggested. In 2021, when I urgently had to take my husband to the ED, I couldn’t see the sign pointing toward the ED and had to ask for directions at the main entrance. They said they would fix that promptly but still have not improved the signage. How I miss the friendly community hospital we had before!
Next was trigger-finger surgery. I had developed that in 1978 from using crutches after a fall. I figured that the relative lull in COVID and my activities made it as good a time as any to finally have it fixed. The surgicenter was great; the surgeon was someone I had worked with and respected for decades. The only glitch was not really knowing how long I was going to be out of commission.
The third encounter (at yet another institution) went really well, despite some early administrative glitches. My major complaint was with the lack of communication between preoperative anesthesia and the operating room and the lack of personalization of preoperative instructions. Despite EPIC, medicines were not correctly reconciled between the different encounters, even on the same day!
After about 15 years of diplopia, which has been gradually worsening, my eye doc had suggested that I consider strabismus surgery as a sort of last-ditch effort to improve my quality of life.
Anesthesiology has stock instructions, which they made no effort to individualize. For example, there is no reason to stop NSAIDs a week before such minor surgery. That’s a problem if you depend on NSAIDs for pain control. Similarly, nothing by mouth after midnight is passé and could be tailored for the patient. I felt particularly inconvenienced that I had to go out of town for the preoperative visit and then have a redundant preoperative clearance by my physician.
The nurses in the preoperative area made me feel quite comfortable and as relaxed as I could be under the circumstances. They had a good sense of humor, which helped too. And from the time I met him a few weeks earlier, I instantly liked my surgeon and felt very comfortable with him and had complete trust.
I was pleased that the chief anesthesiologist responded promptly and undefensively to my letter expressing concerns. I do believe that he will try to improve the systemic problems.
The best part: The surgery appears to have been successful and I should have a significantly improved quality of life.
Hospitals could do so much better by improving communications with patients and by viewing them as customers whose loyalty they must earn and will value. With monopolies growing, memories of such care are quickly fading, soon to be as extinct as the family doc who made house calls.
Dr. Stone is an infectious disease specialist and author of Resilience: One Family’s Story of Hope and Triumph over Evil and Conducting Clinical Research: A Practical Guide. She disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.
‘Eye-opening’ experience on the other side of the hospital bed
The 5 days that she spent at her mother’s bedside were eye-opening for an oncologist used to being on the other side of the clinician–patient relationship.
“As a physician, I thought I had a unique perspective of things that were done well – and things that were not,” commented Pamela Kunz, MD.
Dr. Kunz, who was named the 2021 Woman Oncologist of the Year, is director of the Center for Gastrointestinal Cancers at Smilow Cancer Hospital and of the Yale Cancer Center, New Haven, Conn.
But she was propelled into quite a different role when her mother was admitted to the hospital.
Her mom, who has trouble hearing, was easily confused by jargon and by “all of the people coming in and out with no introductions,” she explained.
“She needed someone to translate what was going on because she didn’t feel well,” she added.
Seeing inpatient care through her mother’s eyes was enlightening, and at times it was “shocking to be on the other side.”
Physicians get used to “checking boxes, getting through the day,” she said. “It’s easy to forget the human side.”
“Seeing a loved one sick, [struggling] through this – I just wished I had seen things done differently,” added Dr. Kunz.
Her thread has since garnered thousands of “likes” and scores of comments and retweets.
She began the Twitter thread explaining what prompted her comments:
“I spent many hours last week observing the practice of medicine while sitting at my mom’s hospital bedside and was reminded of some important communication pearls. Some musings ...”
“1. Introduce yourself by full name, role, and team and have ID badges visible. It can get very confusing for [patients] and family members with the number of people in and out of rooms. E.g. ‘My name is Dr. X. I’m the intern on the primary internal medicine team.’
2. End your patient visit with a summary of the plan for the day.
3. Avoid medical jargon & speak slowly, clearly, and logically. Remember you are a teacher for your [patients] and their family.
4. Masks make it harder to hear, especially for [patients] with hearing loss (and they no longer have the aid of lip reading).
5. Many older [patients] get confused in the hospital. Repetition is a good thing.
6. Speak to a family member at least once per day to relay the plan.
7. Try to avoid last minute or surprise discharges – they make [patients] and family members anxious. Talk about discharge planning from day 1 and what milestones must occur prior to a safe discharge. ‘In order for you to leave the hospital, X, Y, X must happen.’
8. Talk with your [patients] about something other than what brought them to the hospital (a tip I once learned from a wise mentor).
9. When possible, sit at eye level with your patient (I love these stools from @YNHH).
10. Take time to listen.”
Dr. Kunz closed with her golden rule: “Lastly, treat your patients how you would want your own family member treated.”
Twitter user @BrunaPellini replied: “I love this, especially ‘Treat your patients how you would want your own family member treated.’ My mom and grandma always said that to me since I was a med student, and this is definitely one of my core values.”
Other clinicians shared similar experiences, and some added to Dr. Kunz’s list.
“Agree entirely, love the list – and while none of us can always practice perfectly, my experiences with my own mother’s illness taught me an enormous amount about communication,” @hoperugo responded.
Twitter user @mariejacork added: “Everyone in health care please read ... if you are lucky enough to not have had a loved one unwell in hospital, these may get forgotten. Having sat with my dad for a few days before he died a few years ago, I felt a lot of these, and it changed my practice forever.”
@bjcohenmd provided additional advice: “And use the dry erase board that should be in every room. Never start a medication without explaining it. Many docs will see the patient and then go to the computer, decide to order a med, but never go back to explain it.”
Patients also shared experiences and offered suggestions.
“As a chronic pain patient I’d add – we know it’s frustrating you can’t cure us but PLEASE do not SIGH if we say something didn’t work or [tell] us to be more positive. Just say ‘I know this is very hard, I’m here to listen.’ We don’t expect a cure, we do expect to be believed,” said @ppenguinsmt. “It makes me feel like I’m causing distress to you if I say the pain has been unrelenting. I leave feeling worse. ...You may have heard 10 [people] in pain before me but this is MY only [appointment].”
Twitter user @KatieCahoots added: “These are perfect. I wish doctors would do this not only in the hospital but in the doctor’s office, as well. I would add one caveat: When you try not to use medical jargon, don’t dumb it down as though I don’t know anything about science or haven’t done any of my own research.”
Dr. Kunz said she was taken aback but pleased by the response to her Tweet.
“It’s an example of the human side of medicine, so it resonates with physicians and with patients,” she commented. Seeing through her mom’s eyes how care was provided made her realize that medical training should include more emphasis on communication, including “real-time feedback to interns, residents, fellows, and students.”
Yes, it takes time, and “we don’t all have a lot of extra time,” she acknowledged.
“But some of these elements don’t take that much more time to do. They can help build trust and can, in the long run, actually save time if patients understand and family members feel engaged and like they are participants,” she said. “I think a little time investment will go a long way.”
In her case, she very much appreciated the one trainee who tried to call her and update her about her mother’s care each afternoon. “I really valued that,” she said.
A version of this article first appeared on Medscape.com.
The 5 days that she spent at her mother’s bedside were eye-opening for an oncologist used to being on the other side of the clinician–patient relationship.
“As a physician, I thought I had a unique perspective of things that were done well – and things that were not,” commented Pamela Kunz, MD.
Dr. Kunz, who was named the 2021 Woman Oncologist of the Year, is director of the Center for Gastrointestinal Cancers at Smilow Cancer Hospital and of the Yale Cancer Center, New Haven, Conn.
But she was propelled into quite a different role when her mother was admitted to the hospital.
Her mom, who has trouble hearing, was easily confused by jargon and by “all of the people coming in and out with no introductions,” she explained.
“She needed someone to translate what was going on because she didn’t feel well,” she added.
Seeing inpatient care through her mother’s eyes was enlightening, and at times it was “shocking to be on the other side.”
Physicians get used to “checking boxes, getting through the day,” she said. “It’s easy to forget the human side.”
“Seeing a loved one sick, [struggling] through this – I just wished I had seen things done differently,” added Dr. Kunz.
Her thread has since garnered thousands of “likes” and scores of comments and retweets.
She began the Twitter thread explaining what prompted her comments:
“I spent many hours last week observing the practice of medicine while sitting at my mom’s hospital bedside and was reminded of some important communication pearls. Some musings ...”
“1. Introduce yourself by full name, role, and team and have ID badges visible. It can get very confusing for [patients] and family members with the number of people in and out of rooms. E.g. ‘My name is Dr. X. I’m the intern on the primary internal medicine team.’
2. End your patient visit with a summary of the plan for the day.
3. Avoid medical jargon & speak slowly, clearly, and logically. Remember you are a teacher for your [patients] and their family.
4. Masks make it harder to hear, especially for [patients] with hearing loss (and they no longer have the aid of lip reading).
5. Many older [patients] get confused in the hospital. Repetition is a good thing.
6. Speak to a family member at least once per day to relay the plan.
7. Try to avoid last minute or surprise discharges – they make [patients] and family members anxious. Talk about discharge planning from day 1 and what milestones must occur prior to a safe discharge. ‘In order for you to leave the hospital, X, Y, X must happen.’
8. Talk with your [patients] about something other than what brought them to the hospital (a tip I once learned from a wise mentor).
9. When possible, sit at eye level with your patient (I love these stools from @YNHH).
10. Take time to listen.”
Dr. Kunz closed with her golden rule: “Lastly, treat your patients how you would want your own family member treated.”
Twitter user @BrunaPellini replied: “I love this, especially ‘Treat your patients how you would want your own family member treated.’ My mom and grandma always said that to me since I was a med student, and this is definitely one of my core values.”
Other clinicians shared similar experiences, and some added to Dr. Kunz’s list.
“Agree entirely, love the list – and while none of us can always practice perfectly, my experiences with my own mother’s illness taught me an enormous amount about communication,” @hoperugo responded.
Twitter user @mariejacork added: “Everyone in health care please read ... if you are lucky enough to not have had a loved one unwell in hospital, these may get forgotten. Having sat with my dad for a few days before he died a few years ago, I felt a lot of these, and it changed my practice forever.”
@bjcohenmd provided additional advice: “And use the dry erase board that should be in every room. Never start a medication without explaining it. Many docs will see the patient and then go to the computer, decide to order a med, but never go back to explain it.”
Patients also shared experiences and offered suggestions.
“As a chronic pain patient I’d add – we know it’s frustrating you can’t cure us but PLEASE do not SIGH if we say something didn’t work or [tell] us to be more positive. Just say ‘I know this is very hard, I’m here to listen.’ We don’t expect a cure, we do expect to be believed,” said @ppenguinsmt. “It makes me feel like I’m causing distress to you if I say the pain has been unrelenting. I leave feeling worse. ...You may have heard 10 [people] in pain before me but this is MY only [appointment].”
Twitter user @KatieCahoots added: “These are perfect. I wish doctors would do this not only in the hospital but in the doctor’s office, as well. I would add one caveat: When you try not to use medical jargon, don’t dumb it down as though I don’t know anything about science or haven’t done any of my own research.”
Dr. Kunz said she was taken aback but pleased by the response to her Tweet.
“It’s an example of the human side of medicine, so it resonates with physicians and with patients,” she commented. Seeing through her mom’s eyes how care was provided made her realize that medical training should include more emphasis on communication, including “real-time feedback to interns, residents, fellows, and students.”
Yes, it takes time, and “we don’t all have a lot of extra time,” she acknowledged.
“But some of these elements don’t take that much more time to do. They can help build trust and can, in the long run, actually save time if patients understand and family members feel engaged and like they are participants,” she said. “I think a little time investment will go a long way.”
In her case, she very much appreciated the one trainee who tried to call her and update her about her mother’s care each afternoon. “I really valued that,” she said.
A version of this article first appeared on Medscape.com.
The 5 days that she spent at her mother’s bedside were eye-opening for an oncologist used to being on the other side of the clinician–patient relationship.
“As a physician, I thought I had a unique perspective of things that were done well – and things that were not,” commented Pamela Kunz, MD.
Dr. Kunz, who was named the 2021 Woman Oncologist of the Year, is director of the Center for Gastrointestinal Cancers at Smilow Cancer Hospital and of the Yale Cancer Center, New Haven, Conn.
But she was propelled into quite a different role when her mother was admitted to the hospital.
Her mom, who has trouble hearing, was easily confused by jargon and by “all of the people coming in and out with no introductions,” she explained.
“She needed someone to translate what was going on because she didn’t feel well,” she added.
Seeing inpatient care through her mother’s eyes was enlightening, and at times it was “shocking to be on the other side.”
Physicians get used to “checking boxes, getting through the day,” she said. “It’s easy to forget the human side.”
“Seeing a loved one sick, [struggling] through this – I just wished I had seen things done differently,” added Dr. Kunz.
Her thread has since garnered thousands of “likes” and scores of comments and retweets.
She began the Twitter thread explaining what prompted her comments:
“I spent many hours last week observing the practice of medicine while sitting at my mom’s hospital bedside and was reminded of some important communication pearls. Some musings ...”
“1. Introduce yourself by full name, role, and team and have ID badges visible. It can get very confusing for [patients] and family members with the number of people in and out of rooms. E.g. ‘My name is Dr. X. I’m the intern on the primary internal medicine team.’
2. End your patient visit with a summary of the plan for the day.
3. Avoid medical jargon & speak slowly, clearly, and logically. Remember you are a teacher for your [patients] and their family.
4. Masks make it harder to hear, especially for [patients] with hearing loss (and they no longer have the aid of lip reading).
5. Many older [patients] get confused in the hospital. Repetition is a good thing.
6. Speak to a family member at least once per day to relay the plan.
7. Try to avoid last minute or surprise discharges – they make [patients] and family members anxious. Talk about discharge planning from day 1 and what milestones must occur prior to a safe discharge. ‘In order for you to leave the hospital, X, Y, X must happen.’
8. Talk with your [patients] about something other than what brought them to the hospital (a tip I once learned from a wise mentor).
9. When possible, sit at eye level with your patient (I love these stools from @YNHH).
10. Take time to listen.”
Dr. Kunz closed with her golden rule: “Lastly, treat your patients how you would want your own family member treated.”
Twitter user @BrunaPellini replied: “I love this, especially ‘Treat your patients how you would want your own family member treated.’ My mom and grandma always said that to me since I was a med student, and this is definitely one of my core values.”
Other clinicians shared similar experiences, and some added to Dr. Kunz’s list.
“Agree entirely, love the list – and while none of us can always practice perfectly, my experiences with my own mother’s illness taught me an enormous amount about communication,” @hoperugo responded.
Twitter user @mariejacork added: “Everyone in health care please read ... if you are lucky enough to not have had a loved one unwell in hospital, these may get forgotten. Having sat with my dad for a few days before he died a few years ago, I felt a lot of these, and it changed my practice forever.”
@bjcohenmd provided additional advice: “And use the dry erase board that should be in every room. Never start a medication without explaining it. Many docs will see the patient and then go to the computer, decide to order a med, but never go back to explain it.”
Patients also shared experiences and offered suggestions.
“As a chronic pain patient I’d add – we know it’s frustrating you can’t cure us but PLEASE do not SIGH if we say something didn’t work or [tell] us to be more positive. Just say ‘I know this is very hard, I’m here to listen.’ We don’t expect a cure, we do expect to be believed,” said @ppenguinsmt. “It makes me feel like I’m causing distress to you if I say the pain has been unrelenting. I leave feeling worse. ...You may have heard 10 [people] in pain before me but this is MY only [appointment].”
Twitter user @KatieCahoots added: “These are perfect. I wish doctors would do this not only in the hospital but in the doctor’s office, as well. I would add one caveat: When you try not to use medical jargon, don’t dumb it down as though I don’t know anything about science or haven’t done any of my own research.”
Dr. Kunz said she was taken aback but pleased by the response to her Tweet.
“It’s an example of the human side of medicine, so it resonates with physicians and with patients,” she commented. Seeing through her mom’s eyes how care was provided made her realize that medical training should include more emphasis on communication, including “real-time feedback to interns, residents, fellows, and students.”
Yes, it takes time, and “we don’t all have a lot of extra time,” she acknowledged.
“But some of these elements don’t take that much more time to do. They can help build trust and can, in the long run, actually save time if patients understand and family members feel engaged and like they are participants,” she said. “I think a little time investment will go a long way.”
In her case, she very much appreciated the one trainee who tried to call her and update her about her mother’s care each afternoon. “I really valued that,” she said.
A version of this article first appeared on Medscape.com.
We all struggle with the unwritten rules of medical culture
There is a two-lane bridge in my town. It is quaint and picturesque, and when we first moved here, I would gaze out at the water as I drove, letting my mind wander along with the seagulls drifting alongside the car. Until one day, crossing back over, I passed a school bus stopped in the other lane, and instead of waving back, the driver gave me such a fierce look of disapproval I felt like I’d been to the principal’s office. What had I done?
I started paying more attention to the pattern of the other cars on the bridge. Although it appeared to be a standard two-lane width, the lanes weren’t quite wide enough if a school bus or large truck needed to cross at the same time as a car coming from the opposite direction. They had to wait until the other lane was clear. It was an unwritten rule of the town that if you saw a school bus on the other side, you stopped your car and yielded the bridge to the bus. It took me weeks to figure this out. When I did, I felt like I finally belonged in the community. Before, I’d been an outsider.
This got me thinking about culture. Every place has its unwritten rules, whether a community or a workplace. But how do we know the culture of a place? It’s pretty much impossible until we experience it for ourselves.
When I did figure out the bridge, I had a little bit of anger, to be honest. How was I supposed to know about the lanes? There weren’t any signs. Geez.
Now, when I approach the bridge, I don’t even think about it. I know what to do if I see a bus coming.
But sometimes I remember that time of confusion before I deciphered the unwritten rule. I still have a twinge of guilt for having done something wrong, even though it hadn’t been my fault.
It reminded me of a memory from medical training. I was an MS4, and my ER rotation was in a busy county hospital with a level I trauma center. To say that the place was chaotic would be an understatement.
On the first morning, I was shown the chart rack (yes, this was back in the day of paper charts). Charts were placed in the order that patients arrived. Med students and residents were to take a chart in chronological order, go triage and assess the patient, and then find an attending. Once finished, you put the chart back on the rack and picked up the next one. This was the extent of my orientation to the ER.
The days and weeks of the rotation flew by. It was a busy and exciting time. By the end of the month, I’d come to feel a part of the team.
Until one day, after finishing discharging a patient, an attending asked me, “Where’s the billing sheet?”
I had no idea what she was talking about. No one had ever shown me a billing sheet. But by this point, as an MS4, I knew well that if an attending asked you something you didn’t know the answer to, you shouldn’t just say that you didn’t know. You should try to figure out if you could at least approximate an answer first.
As I scrambled in my mind to figure out what she was asking me, she took one look at the apprehension in my eyes and asked again, raising her voice, “You haven’t been doing the billing sheets?”
I thought back to the first day of the rotation. The cursory 30-second orientation. Chart rack. Take one. See the patient. Put it back. See the next patient. Nothing about billing sheets.
“No,” I said. “No one ever told me about – ”
But the attending didn’t care that I hadn’t been instructed on the billing sheets. She ripped into me, yelling about how she couldn’t believe I’d been working there the entire month and was not doing the billing sheets. She showed me what they were and where they were supposed to be going and, in front of the whole staff, treated me like not only the biggest idiot she’d ever worked with but that the hospital had ever seen.
As she berated me, I thought about all the patients I’d seen that month. All the billing sheets I hadn’t placed in the pile. All the attendings who hadn’t gotten credit for the patients they’d staffed with me.
But how could I have known? I wanted to ask. How could I have known if nobody showed me or told me?
It was like the bridge. I was in a new environment and somehow expected to know the rules without anyone telling me; and when I didn’t know, people treated me like I’d done it the wrong way on purpose.
I didn’t end up saying anything more to that attending. What could I have said? She had already unleashed a mountain of her pent-up anger at me.
What I did decide in that moment was that I would never be an attending like that.
Like the bridge, this memory years later can still make me feel guilt and shame for doing something wrong. Even though it wasn’t my fault.
I was thinking about this recently with the Match. Thousands of freshly graduated medical students embarking on their new positions as interns in teaching hospitals across the country.
If someone treats you poorly for not knowing something, you are not an idiot. You’ve worked incredibly hard to get where you are, and you deserve to be there.
For attendings and more senior trainees, remember what it was like to be starting in a new place. We all make mistakes, and often it’s simply because of a lack of information.
Trainees shouldn’t have to suffer and be made to feel like outsiders until they figure out the unwritten rules of the place. They belong.
Dr. Lycette is medical director of Providence Oncology and Hematology Care Clinic, Seaside, Ore. She disclosed no relevant conflicts of interest. A version of this article first appeared on Medscape.com.
There is a two-lane bridge in my town. It is quaint and picturesque, and when we first moved here, I would gaze out at the water as I drove, letting my mind wander along with the seagulls drifting alongside the car. Until one day, crossing back over, I passed a school bus stopped in the other lane, and instead of waving back, the driver gave me such a fierce look of disapproval I felt like I’d been to the principal’s office. What had I done?
I started paying more attention to the pattern of the other cars on the bridge. Although it appeared to be a standard two-lane width, the lanes weren’t quite wide enough if a school bus or large truck needed to cross at the same time as a car coming from the opposite direction. They had to wait until the other lane was clear. It was an unwritten rule of the town that if you saw a school bus on the other side, you stopped your car and yielded the bridge to the bus. It took me weeks to figure this out. When I did, I felt like I finally belonged in the community. Before, I’d been an outsider.
This got me thinking about culture. Every place has its unwritten rules, whether a community or a workplace. But how do we know the culture of a place? It’s pretty much impossible until we experience it for ourselves.
When I did figure out the bridge, I had a little bit of anger, to be honest. How was I supposed to know about the lanes? There weren’t any signs. Geez.
Now, when I approach the bridge, I don’t even think about it. I know what to do if I see a bus coming.
But sometimes I remember that time of confusion before I deciphered the unwritten rule. I still have a twinge of guilt for having done something wrong, even though it hadn’t been my fault.
It reminded me of a memory from medical training. I was an MS4, and my ER rotation was in a busy county hospital with a level I trauma center. To say that the place was chaotic would be an understatement.
On the first morning, I was shown the chart rack (yes, this was back in the day of paper charts). Charts were placed in the order that patients arrived. Med students and residents were to take a chart in chronological order, go triage and assess the patient, and then find an attending. Once finished, you put the chart back on the rack and picked up the next one. This was the extent of my orientation to the ER.
The days and weeks of the rotation flew by. It was a busy and exciting time. By the end of the month, I’d come to feel a part of the team.
Until one day, after finishing discharging a patient, an attending asked me, “Where’s the billing sheet?”
I had no idea what she was talking about. No one had ever shown me a billing sheet. But by this point, as an MS4, I knew well that if an attending asked you something you didn’t know the answer to, you shouldn’t just say that you didn’t know. You should try to figure out if you could at least approximate an answer first.
As I scrambled in my mind to figure out what she was asking me, she took one look at the apprehension in my eyes and asked again, raising her voice, “You haven’t been doing the billing sheets?”
I thought back to the first day of the rotation. The cursory 30-second orientation. Chart rack. Take one. See the patient. Put it back. See the next patient. Nothing about billing sheets.
“No,” I said. “No one ever told me about – ”
But the attending didn’t care that I hadn’t been instructed on the billing sheets. She ripped into me, yelling about how she couldn’t believe I’d been working there the entire month and was not doing the billing sheets. She showed me what they were and where they were supposed to be going and, in front of the whole staff, treated me like not only the biggest idiot she’d ever worked with but that the hospital had ever seen.
As she berated me, I thought about all the patients I’d seen that month. All the billing sheets I hadn’t placed in the pile. All the attendings who hadn’t gotten credit for the patients they’d staffed with me.
But how could I have known? I wanted to ask. How could I have known if nobody showed me or told me?
It was like the bridge. I was in a new environment and somehow expected to know the rules without anyone telling me; and when I didn’t know, people treated me like I’d done it the wrong way on purpose.
I didn’t end up saying anything more to that attending. What could I have said? She had already unleashed a mountain of her pent-up anger at me.
What I did decide in that moment was that I would never be an attending like that.
Like the bridge, this memory years later can still make me feel guilt and shame for doing something wrong. Even though it wasn’t my fault.
I was thinking about this recently with the Match. Thousands of freshly graduated medical students embarking on their new positions as interns in teaching hospitals across the country.
If someone treats you poorly for not knowing something, you are not an idiot. You’ve worked incredibly hard to get where you are, and you deserve to be there.
For attendings and more senior trainees, remember what it was like to be starting in a new place. We all make mistakes, and often it’s simply because of a lack of information.
Trainees shouldn’t have to suffer and be made to feel like outsiders until they figure out the unwritten rules of the place. They belong.
Dr. Lycette is medical director of Providence Oncology and Hematology Care Clinic, Seaside, Ore. She disclosed no relevant conflicts of interest. A version of this article first appeared on Medscape.com.
There is a two-lane bridge in my town. It is quaint and picturesque, and when we first moved here, I would gaze out at the water as I drove, letting my mind wander along with the seagulls drifting alongside the car. Until one day, crossing back over, I passed a school bus stopped in the other lane, and instead of waving back, the driver gave me such a fierce look of disapproval I felt like I’d been to the principal’s office. What had I done?
I started paying more attention to the pattern of the other cars on the bridge. Although it appeared to be a standard two-lane width, the lanes weren’t quite wide enough if a school bus or large truck needed to cross at the same time as a car coming from the opposite direction. They had to wait until the other lane was clear. It was an unwritten rule of the town that if you saw a school bus on the other side, you stopped your car and yielded the bridge to the bus. It took me weeks to figure this out. When I did, I felt like I finally belonged in the community. Before, I’d been an outsider.
This got me thinking about culture. Every place has its unwritten rules, whether a community or a workplace. But how do we know the culture of a place? It’s pretty much impossible until we experience it for ourselves.
When I did figure out the bridge, I had a little bit of anger, to be honest. How was I supposed to know about the lanes? There weren’t any signs. Geez.
Now, when I approach the bridge, I don’t even think about it. I know what to do if I see a bus coming.
But sometimes I remember that time of confusion before I deciphered the unwritten rule. I still have a twinge of guilt for having done something wrong, even though it hadn’t been my fault.
It reminded me of a memory from medical training. I was an MS4, and my ER rotation was in a busy county hospital with a level I trauma center. To say that the place was chaotic would be an understatement.
On the first morning, I was shown the chart rack (yes, this was back in the day of paper charts). Charts were placed in the order that patients arrived. Med students and residents were to take a chart in chronological order, go triage and assess the patient, and then find an attending. Once finished, you put the chart back on the rack and picked up the next one. This was the extent of my orientation to the ER.
The days and weeks of the rotation flew by. It was a busy and exciting time. By the end of the month, I’d come to feel a part of the team.
Until one day, after finishing discharging a patient, an attending asked me, “Where’s the billing sheet?”
I had no idea what she was talking about. No one had ever shown me a billing sheet. But by this point, as an MS4, I knew well that if an attending asked you something you didn’t know the answer to, you shouldn’t just say that you didn’t know. You should try to figure out if you could at least approximate an answer first.
As I scrambled in my mind to figure out what she was asking me, she took one look at the apprehension in my eyes and asked again, raising her voice, “You haven’t been doing the billing sheets?”
I thought back to the first day of the rotation. The cursory 30-second orientation. Chart rack. Take one. See the patient. Put it back. See the next patient. Nothing about billing sheets.
“No,” I said. “No one ever told me about – ”
But the attending didn’t care that I hadn’t been instructed on the billing sheets. She ripped into me, yelling about how she couldn’t believe I’d been working there the entire month and was not doing the billing sheets. She showed me what they were and where they were supposed to be going and, in front of the whole staff, treated me like not only the biggest idiot she’d ever worked with but that the hospital had ever seen.
As she berated me, I thought about all the patients I’d seen that month. All the billing sheets I hadn’t placed in the pile. All the attendings who hadn’t gotten credit for the patients they’d staffed with me.
But how could I have known? I wanted to ask. How could I have known if nobody showed me or told me?
It was like the bridge. I was in a new environment and somehow expected to know the rules without anyone telling me; and when I didn’t know, people treated me like I’d done it the wrong way on purpose.
I didn’t end up saying anything more to that attending. What could I have said? She had already unleashed a mountain of her pent-up anger at me.
What I did decide in that moment was that I would never be an attending like that.
Like the bridge, this memory years later can still make me feel guilt and shame for doing something wrong. Even though it wasn’t my fault.
I was thinking about this recently with the Match. Thousands of freshly graduated medical students embarking on their new positions as interns in teaching hospitals across the country.
If someone treats you poorly for not knowing something, you are not an idiot. You’ve worked incredibly hard to get where you are, and you deserve to be there.
For attendings and more senior trainees, remember what it was like to be starting in a new place. We all make mistakes, and often it’s simply because of a lack of information.
Trainees shouldn’t have to suffer and be made to feel like outsiders until they figure out the unwritten rules of the place. They belong.
Dr. Lycette is medical director of Providence Oncology and Hematology Care Clinic, Seaside, Ore. She disclosed no relevant conflicts of interest. A version of this article first appeared on Medscape.com.
Flu vaccines cut seasonal death in heart failure patients
WASHINGTON – Patients with heart failure who received an annual influenza vaccine for 3 years running had significantly fewer all-cause hospitalizations and significantly fewer cases of pneumonia during that time, compared with placebo-treated patients with heart failure, in a prospective, randomized, global trial with 5,129 participants.
Although the results failed to show a significant reduction in all-cause deaths linked to influenza vaccination, compared with controls during the entire 3 years of the study, the results did show a significant 21% relative mortality-risk reduction by vaccination during periods of peak influenza circulation, and a significant 23% reduction in cardiovascular deaths, compared with controls during peak seasons.
“This is the first randomized, controlled trial of influenza vaccine in patients with heart failure, and we showed that vaccination reduces deaths” during peak influenza seasons, Mark Loeb, MD, said during a press briefing at the annual scientific sessions of the American College of Cardiology. The results send “an important global message that patients with heart failure should receive the influenza vaccine,” said Dr. Loeb, a professor at McMaster University, Hamilton, Ont., who specializes in clinical epidemiology and infectious diseases.
Dr. Loeb admitted that he and his associates erred when they picked the time window to assess the two primary endpoints for the trial: the combined rate of cardiovascular death, nonfatal MI, and nonfatal stroke, and this combined endpoint plus hospitalizations for heart failure.
The time window they selected was the entirety of all 3 years following three annual immunizations. That was a mistake.
No flu vaccine benefit outside flu season
“We know that the influenza vaccine will not have any effect outside of when influenza is circulating. In retrospect, we should have done that,” Dr. Loeb bemoaned during his talk. He chalked up the bad choice to concern over collecting enough endpoints to see a significant between-group difference when the researchers designed the study.
For the entire 3 years of follow-up, influenza vaccination was tied to a nonsignificant 7% relative risk reduction for the first primary endpoint, and a nonsignificant 9% relative risk reduction for the second primary endpoint, he reported.
But Dr. Loeb lobbied for the relevance of several significant secondary endpoints that collectively showed a compelling pattern of benefit during his talk. These included, for the full 3-years of follow-up, important, significant reductions relative to placebo of 16% for first all-cause hospitalizations (P = .01), and a 42% relative risk reduction in first cases of pneumonia (P = .0006).
Then there were the benefits that appeared during influenza season. In that analysis, first events for the first primary endpoint fell after vaccination by a significant 18% relative to placebo. The in-season analysis also showed the significant cuts in both all-cause and cardiovascular deaths.
Despite the neutral primary endpoints, “if you look at these data as a whole I think they speak to the importance of vaccinating patients with heart failure against influenza,” Dr. Loeb maintained.
‘Totality of evidence supports vaccination’
“I agree that the totality of evidence supports influenza vaccination,” commented Mark H. Drazner, MD, professor and clinical chief of cardiology at the University of Texas Southwestern Medical Center, Dallas, who was designated discussant for the report.
“The message should be to offer influenza vaccine to patients with heart failure,” Dr. Drazner said in an interview. “Previous data on influenza vaccine in patients with heart failure were largely observational. This was a randomized, prospective, placebo-controlled trial. That’s a step forward. Proving efficacy in a randomized trial is important.”
Dr Drazner added that his institution already promotes a “strong mandate” to vaccinate patients with heart failure against influenza.
“The influenza vaccine is a very effective and cost-efficient public health measure. Preventing hospitalizations of patients with heart failure has so many benefits,” commented Craig Beavers, PharmD, vice president of professional services at Baptist Health in Paducah, Ky., and a discussant during the press briefing.
The Influenza Vaccine To Prevent Adverse Vascular Events (IVVE) trial enrolled people with heart failure in New York Heart Association functional class II, III, or IV from any of 10 low- and middle-income countries including China, India, the Philippines, and multiple countries from Africa and the Middle East. They averaged 57 years of age, and slightly more than half were women.
IVVE was sponsored by McMaster University; the only commercial support that IVVE received was a free supply of influenza vaccine from Sanofi Pasteur. Dr. Loeb, Dr. Drazner, and Dr. Beavers had no disclosures.
WASHINGTON – Patients with heart failure who received an annual influenza vaccine for 3 years running had significantly fewer all-cause hospitalizations and significantly fewer cases of pneumonia during that time, compared with placebo-treated patients with heart failure, in a prospective, randomized, global trial with 5,129 participants.
Although the results failed to show a significant reduction in all-cause deaths linked to influenza vaccination, compared with controls during the entire 3 years of the study, the results did show a significant 21% relative mortality-risk reduction by vaccination during periods of peak influenza circulation, and a significant 23% reduction in cardiovascular deaths, compared with controls during peak seasons.
“This is the first randomized, controlled trial of influenza vaccine in patients with heart failure, and we showed that vaccination reduces deaths” during peak influenza seasons, Mark Loeb, MD, said during a press briefing at the annual scientific sessions of the American College of Cardiology. The results send “an important global message that patients with heart failure should receive the influenza vaccine,” said Dr. Loeb, a professor at McMaster University, Hamilton, Ont., who specializes in clinical epidemiology and infectious diseases.
Dr. Loeb admitted that he and his associates erred when they picked the time window to assess the two primary endpoints for the trial: the combined rate of cardiovascular death, nonfatal MI, and nonfatal stroke, and this combined endpoint plus hospitalizations for heart failure.
The time window they selected was the entirety of all 3 years following three annual immunizations. That was a mistake.
No flu vaccine benefit outside flu season
“We know that the influenza vaccine will not have any effect outside of when influenza is circulating. In retrospect, we should have done that,” Dr. Loeb bemoaned during his talk. He chalked up the bad choice to concern over collecting enough endpoints to see a significant between-group difference when the researchers designed the study.
For the entire 3 years of follow-up, influenza vaccination was tied to a nonsignificant 7% relative risk reduction for the first primary endpoint, and a nonsignificant 9% relative risk reduction for the second primary endpoint, he reported.
But Dr. Loeb lobbied for the relevance of several significant secondary endpoints that collectively showed a compelling pattern of benefit during his talk. These included, for the full 3-years of follow-up, important, significant reductions relative to placebo of 16% for first all-cause hospitalizations (P = .01), and a 42% relative risk reduction in first cases of pneumonia (P = .0006).
Then there were the benefits that appeared during influenza season. In that analysis, first events for the first primary endpoint fell after vaccination by a significant 18% relative to placebo. The in-season analysis also showed the significant cuts in both all-cause and cardiovascular deaths.
Despite the neutral primary endpoints, “if you look at these data as a whole I think they speak to the importance of vaccinating patients with heart failure against influenza,” Dr. Loeb maintained.
‘Totality of evidence supports vaccination’
“I agree that the totality of evidence supports influenza vaccination,” commented Mark H. Drazner, MD, professor and clinical chief of cardiology at the University of Texas Southwestern Medical Center, Dallas, who was designated discussant for the report.
“The message should be to offer influenza vaccine to patients with heart failure,” Dr. Drazner said in an interview. “Previous data on influenza vaccine in patients with heart failure were largely observational. This was a randomized, prospective, placebo-controlled trial. That’s a step forward. Proving efficacy in a randomized trial is important.”
Dr Drazner added that his institution already promotes a “strong mandate” to vaccinate patients with heart failure against influenza.
“The influenza vaccine is a very effective and cost-efficient public health measure. Preventing hospitalizations of patients with heart failure has so many benefits,” commented Craig Beavers, PharmD, vice president of professional services at Baptist Health in Paducah, Ky., and a discussant during the press briefing.
The Influenza Vaccine To Prevent Adverse Vascular Events (IVVE) trial enrolled people with heart failure in New York Heart Association functional class II, III, or IV from any of 10 low- and middle-income countries including China, India, the Philippines, and multiple countries from Africa and the Middle East. They averaged 57 years of age, and slightly more than half were women.
IVVE was sponsored by McMaster University; the only commercial support that IVVE received was a free supply of influenza vaccine from Sanofi Pasteur. Dr. Loeb, Dr. Drazner, and Dr. Beavers had no disclosures.
WASHINGTON – Patients with heart failure who received an annual influenza vaccine for 3 years running had significantly fewer all-cause hospitalizations and significantly fewer cases of pneumonia during that time, compared with placebo-treated patients with heart failure, in a prospective, randomized, global trial with 5,129 participants.
Although the results failed to show a significant reduction in all-cause deaths linked to influenza vaccination, compared with controls during the entire 3 years of the study, the results did show a significant 21% relative mortality-risk reduction by vaccination during periods of peak influenza circulation, and a significant 23% reduction in cardiovascular deaths, compared with controls during peak seasons.
“This is the first randomized, controlled trial of influenza vaccine in patients with heart failure, and we showed that vaccination reduces deaths” during peak influenza seasons, Mark Loeb, MD, said during a press briefing at the annual scientific sessions of the American College of Cardiology. The results send “an important global message that patients with heart failure should receive the influenza vaccine,” said Dr. Loeb, a professor at McMaster University, Hamilton, Ont., who specializes in clinical epidemiology and infectious diseases.
Dr. Loeb admitted that he and his associates erred when they picked the time window to assess the two primary endpoints for the trial: the combined rate of cardiovascular death, nonfatal MI, and nonfatal stroke, and this combined endpoint plus hospitalizations for heart failure.
The time window they selected was the entirety of all 3 years following three annual immunizations. That was a mistake.
No flu vaccine benefit outside flu season
“We know that the influenza vaccine will not have any effect outside of when influenza is circulating. In retrospect, we should have done that,” Dr. Loeb bemoaned during his talk. He chalked up the bad choice to concern over collecting enough endpoints to see a significant between-group difference when the researchers designed the study.
For the entire 3 years of follow-up, influenza vaccination was tied to a nonsignificant 7% relative risk reduction for the first primary endpoint, and a nonsignificant 9% relative risk reduction for the second primary endpoint, he reported.
But Dr. Loeb lobbied for the relevance of several significant secondary endpoints that collectively showed a compelling pattern of benefit during his talk. These included, for the full 3-years of follow-up, important, significant reductions relative to placebo of 16% for first all-cause hospitalizations (P = .01), and a 42% relative risk reduction in first cases of pneumonia (P = .0006).
Then there were the benefits that appeared during influenza season. In that analysis, first events for the first primary endpoint fell after vaccination by a significant 18% relative to placebo. The in-season analysis also showed the significant cuts in both all-cause and cardiovascular deaths.
Despite the neutral primary endpoints, “if you look at these data as a whole I think they speak to the importance of vaccinating patients with heart failure against influenza,” Dr. Loeb maintained.
‘Totality of evidence supports vaccination’
“I agree that the totality of evidence supports influenza vaccination,” commented Mark H. Drazner, MD, professor and clinical chief of cardiology at the University of Texas Southwestern Medical Center, Dallas, who was designated discussant for the report.
“The message should be to offer influenza vaccine to patients with heart failure,” Dr. Drazner said in an interview. “Previous data on influenza vaccine in patients with heart failure were largely observational. This was a randomized, prospective, placebo-controlled trial. That’s a step forward. Proving efficacy in a randomized trial is important.”
Dr Drazner added that his institution already promotes a “strong mandate” to vaccinate patients with heart failure against influenza.
“The influenza vaccine is a very effective and cost-efficient public health measure. Preventing hospitalizations of patients with heart failure has so many benefits,” commented Craig Beavers, PharmD, vice president of professional services at Baptist Health in Paducah, Ky., and a discussant during the press briefing.
The Influenza Vaccine To Prevent Adverse Vascular Events (IVVE) trial enrolled people with heart failure in New York Heart Association functional class II, III, or IV from any of 10 low- and middle-income countries including China, India, the Philippines, and multiple countries from Africa and the Middle East. They averaged 57 years of age, and slightly more than half were women.
IVVE was sponsored by McMaster University; the only commercial support that IVVE received was a free supply of influenza vaccine from Sanofi Pasteur. Dr. Loeb, Dr. Drazner, and Dr. Beavers had no disclosures.
AT ACC 2022
Anticoagulation not routinely needed after TAVR: ADAPT-TAVR
In patients undergoing transcatheter aortic valve replacement (TAVR), the incidence of leaflet thrombosis was numerically lower in those treated with the anticoagulant edoxaban for 6 months after the procedure than in those who received dual antiplatelet therapy, although the difference was not statistically significant, in the ADAPT-TAVR study.
There was no difference in new cerebral thromboembolism or neurologic/neurocognitive function between the two groups in the study.
Also, there was no significant relation between subclinical leaflet thrombosis and increased risk for cerebral thromboembolism and neurologic dysfunction.
The ADAPT-TAVR trial was presented April 4 at the American College of Cardiology (ACC) 2022 Scientific Session by Duk-Woo Park, MD, Asan Medical Center, Seoul, South Korea. It was simultaneously published online in Circulation.
“The key messages from this study are that subclinical leaflet thrombosis has not been proven to affect clinical outcomes for patients undergoing valve replacement and that in patients in whom leaflet thrombosis causes no symptoms or complications, its presence should not dictate the type of antithrombotic therapy that patients receive following the implantation of an artificial heart valve,” Dr. Park said.
“These findings do not support the routine use of computed tomography scans to detect subclinical leaflet thrombosis,” he added.
Commenting on the study at an ACC press conference, Megan Coylewright, MD, director of the Structural Heart Program at Erlanger Health System, Chattanooga, Tennessee, said: “Oftentimes when studies are negative, we’re disappointed. In this case, I think we are pleased that the study is negative because it suggests we do not have to expose our TAVR patients to anticoagulation for benefit.”
Dr. Coylewright explained that the ADAPT-TAVR study was asking whether clots form on the valve, as defined by CT.
“We are worried about that for two reasons: could that clot cause a stroke, and could that clot cause the valve to break down over time. This study looked at the first issue. And it found that there was some clot build up on the valve, but that it wasn’t significantly different between the anticoagulant and dual antiplatelet groups. And there was no correlation with embolic events, she noted.
“It shows how fast our field moves. In the U.S. now, we are using aspirin alone at 81 mg for patients who do not have an indication for oral anticoagulation after TAVR. We are moving away from dual antiplatelet therapy because the bleeding risk is so bad,” Dr. Coylewright said.
In his presentation, Dr. Park explained that it is believed that oral anticoagulants are more effective than antiplatelet therapy at reducing subclinical leaflet thrombosis, but it is not known whether there is a causal association between subclinical leaflet thrombosis and cerebral embolism, or whether oral anticoagulation can reduce cerebral embolism related to subclinical leaflet thrombosis.
The ADAPT-TAVR was conducted to look at these issues. The open-label randomized trial was conducted in five centers in Hong Kong, South Korea, and Taiwan.
For the study, 229 patients who had undergone successful TAVR and did not have an indication for anticoagulation were randomized to edoxaban 60 mg once daily, edoxaban 30 mg once daily for patients needing a reduced dose, or dual antiplatelet therapy for 6 months.
The primary endpoint was an incidence of leaflet thrombosis on four-dimensional CT at 6 months.
Results showed a strong trend toward a lower incidence of leaflet thrombosis in the edoxaban groups than in the dual antiplatelet group (9.8% vs. 18.4%; P = .076).
There was a nonsignificant difference in the percentage of patients with new cerebral lesions identified on brain MRI between the edoxaban and dual antiplatelet groups (25.0% vs. 20.2%).
The percentage of patients with worsening of neurologic and neurocognitive function was not different among the groups.
The incidence of any or major bleeding events was not different between two therapies.
There was also no significant association of the presence or extent of leaflet thrombosis with new cerebral lesions or change of neurologic or neurocognitive function.
Dr. Park noted that the trial had several limitations, including an open-label design, use of surrogate imaging outcomes for the primary outcome, and the relatively short follow-up period, so the study was underpowered to detect any meaningful differences in clinical efficacy and safety outcomes. The results should thus be considered hypothesis-generating, highlighting the need for further research, he added.
The long-term effect of leaflet thrombosis or different antithrombotic strategies on bioprosthetic valve durability is still unknown, Dr. Park said.
He also pointed out that the findings cannot be directly extrapolated to patients with an established indication for oral anticoagulant therapy.
The ADAPT-TAVR trial was an investigator-initiated trial and was funded by the CardioVascular Research Foundation (Seoul, Korea) and Daiichi Sankyo Korea.
A version of this article first appeared on Medscape.com.
In patients undergoing transcatheter aortic valve replacement (TAVR), the incidence of leaflet thrombosis was numerically lower in those treated with the anticoagulant edoxaban for 6 months after the procedure than in those who received dual antiplatelet therapy, although the difference was not statistically significant, in the ADAPT-TAVR study.
There was no difference in new cerebral thromboembolism or neurologic/neurocognitive function between the two groups in the study.
Also, there was no significant relation between subclinical leaflet thrombosis and increased risk for cerebral thromboembolism and neurologic dysfunction.
The ADAPT-TAVR trial was presented April 4 at the American College of Cardiology (ACC) 2022 Scientific Session by Duk-Woo Park, MD, Asan Medical Center, Seoul, South Korea. It was simultaneously published online in Circulation.
“The key messages from this study are that subclinical leaflet thrombosis has not been proven to affect clinical outcomes for patients undergoing valve replacement and that in patients in whom leaflet thrombosis causes no symptoms or complications, its presence should not dictate the type of antithrombotic therapy that patients receive following the implantation of an artificial heart valve,” Dr. Park said.
“These findings do not support the routine use of computed tomography scans to detect subclinical leaflet thrombosis,” he added.
Commenting on the study at an ACC press conference, Megan Coylewright, MD, director of the Structural Heart Program at Erlanger Health System, Chattanooga, Tennessee, said: “Oftentimes when studies are negative, we’re disappointed. In this case, I think we are pleased that the study is negative because it suggests we do not have to expose our TAVR patients to anticoagulation for benefit.”
Dr. Coylewright explained that the ADAPT-TAVR study was asking whether clots form on the valve, as defined by CT.
“We are worried about that for two reasons: could that clot cause a stroke, and could that clot cause the valve to break down over time. This study looked at the first issue. And it found that there was some clot build up on the valve, but that it wasn’t significantly different between the anticoagulant and dual antiplatelet groups. And there was no correlation with embolic events, she noted.
“It shows how fast our field moves. In the U.S. now, we are using aspirin alone at 81 mg for patients who do not have an indication for oral anticoagulation after TAVR. We are moving away from dual antiplatelet therapy because the bleeding risk is so bad,” Dr. Coylewright said.
In his presentation, Dr. Park explained that it is believed that oral anticoagulants are more effective than antiplatelet therapy at reducing subclinical leaflet thrombosis, but it is not known whether there is a causal association between subclinical leaflet thrombosis and cerebral embolism, or whether oral anticoagulation can reduce cerebral embolism related to subclinical leaflet thrombosis.
The ADAPT-TAVR was conducted to look at these issues. The open-label randomized trial was conducted in five centers in Hong Kong, South Korea, and Taiwan.
For the study, 229 patients who had undergone successful TAVR and did not have an indication for anticoagulation were randomized to edoxaban 60 mg once daily, edoxaban 30 mg once daily for patients needing a reduced dose, or dual antiplatelet therapy for 6 months.
The primary endpoint was an incidence of leaflet thrombosis on four-dimensional CT at 6 months.
Results showed a strong trend toward a lower incidence of leaflet thrombosis in the edoxaban groups than in the dual antiplatelet group (9.8% vs. 18.4%; P = .076).
There was a nonsignificant difference in the percentage of patients with new cerebral lesions identified on brain MRI between the edoxaban and dual antiplatelet groups (25.0% vs. 20.2%).
The percentage of patients with worsening of neurologic and neurocognitive function was not different among the groups.
The incidence of any or major bleeding events was not different between two therapies.
There was also no significant association of the presence or extent of leaflet thrombosis with new cerebral lesions or change of neurologic or neurocognitive function.
Dr. Park noted that the trial had several limitations, including an open-label design, use of surrogate imaging outcomes for the primary outcome, and the relatively short follow-up period, so the study was underpowered to detect any meaningful differences in clinical efficacy and safety outcomes. The results should thus be considered hypothesis-generating, highlighting the need for further research, he added.
The long-term effect of leaflet thrombosis or different antithrombotic strategies on bioprosthetic valve durability is still unknown, Dr. Park said.
He also pointed out that the findings cannot be directly extrapolated to patients with an established indication for oral anticoagulant therapy.
The ADAPT-TAVR trial was an investigator-initiated trial and was funded by the CardioVascular Research Foundation (Seoul, Korea) and Daiichi Sankyo Korea.
A version of this article first appeared on Medscape.com.
In patients undergoing transcatheter aortic valve replacement (TAVR), the incidence of leaflet thrombosis was numerically lower in those treated with the anticoagulant edoxaban for 6 months after the procedure than in those who received dual antiplatelet therapy, although the difference was not statistically significant, in the ADAPT-TAVR study.
There was no difference in new cerebral thromboembolism or neurologic/neurocognitive function between the two groups in the study.
Also, there was no significant relation between subclinical leaflet thrombosis and increased risk for cerebral thromboembolism and neurologic dysfunction.
The ADAPT-TAVR trial was presented April 4 at the American College of Cardiology (ACC) 2022 Scientific Session by Duk-Woo Park, MD, Asan Medical Center, Seoul, South Korea. It was simultaneously published online in Circulation.
“The key messages from this study are that subclinical leaflet thrombosis has not been proven to affect clinical outcomes for patients undergoing valve replacement and that in patients in whom leaflet thrombosis causes no symptoms or complications, its presence should not dictate the type of antithrombotic therapy that patients receive following the implantation of an artificial heart valve,” Dr. Park said.
“These findings do not support the routine use of computed tomography scans to detect subclinical leaflet thrombosis,” he added.
Commenting on the study at an ACC press conference, Megan Coylewright, MD, director of the Structural Heart Program at Erlanger Health System, Chattanooga, Tennessee, said: “Oftentimes when studies are negative, we’re disappointed. In this case, I think we are pleased that the study is negative because it suggests we do not have to expose our TAVR patients to anticoagulation for benefit.”
Dr. Coylewright explained that the ADAPT-TAVR study was asking whether clots form on the valve, as defined by CT.
“We are worried about that for two reasons: could that clot cause a stroke, and could that clot cause the valve to break down over time. This study looked at the first issue. And it found that there was some clot build up on the valve, but that it wasn’t significantly different between the anticoagulant and dual antiplatelet groups. And there was no correlation with embolic events, she noted.
“It shows how fast our field moves. In the U.S. now, we are using aspirin alone at 81 mg for patients who do not have an indication for oral anticoagulation after TAVR. We are moving away from dual antiplatelet therapy because the bleeding risk is so bad,” Dr. Coylewright said.
In his presentation, Dr. Park explained that it is believed that oral anticoagulants are more effective than antiplatelet therapy at reducing subclinical leaflet thrombosis, but it is not known whether there is a causal association between subclinical leaflet thrombosis and cerebral embolism, or whether oral anticoagulation can reduce cerebral embolism related to subclinical leaflet thrombosis.
The ADAPT-TAVR was conducted to look at these issues. The open-label randomized trial was conducted in five centers in Hong Kong, South Korea, and Taiwan.
For the study, 229 patients who had undergone successful TAVR and did not have an indication for anticoagulation were randomized to edoxaban 60 mg once daily, edoxaban 30 mg once daily for patients needing a reduced dose, or dual antiplatelet therapy for 6 months.
The primary endpoint was an incidence of leaflet thrombosis on four-dimensional CT at 6 months.
Results showed a strong trend toward a lower incidence of leaflet thrombosis in the edoxaban groups than in the dual antiplatelet group (9.8% vs. 18.4%; P = .076).
There was a nonsignificant difference in the percentage of patients with new cerebral lesions identified on brain MRI between the edoxaban and dual antiplatelet groups (25.0% vs. 20.2%).
The percentage of patients with worsening of neurologic and neurocognitive function was not different among the groups.
The incidence of any or major bleeding events was not different between two therapies.
There was also no significant association of the presence or extent of leaflet thrombosis with new cerebral lesions or change of neurologic or neurocognitive function.
Dr. Park noted that the trial had several limitations, including an open-label design, use of surrogate imaging outcomes for the primary outcome, and the relatively short follow-up period, so the study was underpowered to detect any meaningful differences in clinical efficacy and safety outcomes. The results should thus be considered hypothesis-generating, highlighting the need for further research, he added.
The long-term effect of leaflet thrombosis or different antithrombotic strategies on bioprosthetic valve durability is still unknown, Dr. Park said.
He also pointed out that the findings cannot be directly extrapolated to patients with an established indication for oral anticoagulant therapy.
The ADAPT-TAVR trial was an investigator-initiated trial and was funded by the CardioVascular Research Foundation (Seoul, Korea) and Daiichi Sankyo Korea.
A version of this article first appeared on Medscape.com.
Early PCSK9 inhibition in AMI yields plaque regression
When the PCSK9 inhibitor alirocumab is added to high-intensity statins soon after an acute myocardial infarction (AMI), the reduction in atheroma volume is doubled at 12 months, compared with placebo, while other key signs of plaque stabilization, such as fibrous cap thickness, are also significantly and substantially improved, according to the results of the PACMAN-AMI trial.
The study is consistent with other PCSK9 inhibitor trials, supporting the concept that “we should be seeking very low levels of LDL-C in high-risk patients,” reported Lorenz Räber, MD, PhD, of Bern (Switz.) University Hospital, at the annual scientific sessions of the American College of Cardiology.
The low LCL-C target, the data from PACMAN-AMI suggest, is below 50 mg/dL, but even lower is better. When displayed graphically, the improvements in remodeling characteristics “get very steep” as levels descend below a 50 mg/dL threshold, Dr. Räber reported. This was true regardless of study arm.
In PACMAN-AMI, 300 AMI patients (with either ST-elevation or non-ST-elevaion) were randomized to 150 mg alirocumab or placebo administered by subcutaneous injection within 24 hours after an urgent percutaneous intervention (PCI) and stent placement. All patients received their assigned therapy on top of a high-intensity statin in the form of 20 mg of rosuvastatin daily.
Primary outcome was atheroma volume
The primary endpoint was atheroma volume as determined by intravenous ultrasound (IVUS), but the secondary endpoints of maximum lipid core burden, as determined by near infrared spectroscopy (NIRS), and fibrous cap thickness, as determined by optical coherence tomography (OCT), were also adequately powered, according to Dr. Räber.
The imaging measures taken at baseline were repeated in exactly the same spot after 52 weeks on treatment.
For the primary outcome of atheroma volume, the mean 2.1% reduction among those randomized to alirocumab was more than double the 0.9% reduction in the placebo group (P = .001).
The mean reduction in lipid core volume based on a maximum lipid core burden index was also more than doubled (-79.42 vs. -37.60 maxLCBI4mm; P = .006). The increase in fibrous cap thickness was not quite twofold greater but very close (62.67 vs. 33.19 mcm; P = .001).
From baseline, the relative reductions in LDL-C, which were reached about 4 weeks after starting treatment and maintained over the course of the study, were greater in the group randomized to alirocumab (-84.8% vs. -50.7%). This was expected, but the more important finding was a near linear relationship between reductions of LDL-C and each of these endpoints regardless of treatment, fully explaining the advantage of alirocumab, according to Dr. Räber.
For the addition of alirocumab, “these findings indicate incremental coronary plaque regression, lipid core reduction, and plaque stabilization, and provide a mechanistic rationale in favor of early initiation of very intensive LDL-C lower in the setting of an acute MI,” he said.
The results of the PACMAN-AMI trial were published simultaneously at the time of the ACC presentation.
Results consistent with earlier trials
Alirocumab was well tolerated. Injection site reactions (6.1% vs. 3.3%) and general allergic reactions (3.4% vs. 0%) were more common on alirocumab, but there were no significant differences between the arms of this study for serious adverse events. There were slightly more neurocognitive events (2.0 vs. 0%) and abnormal alanine transferase levels (0.7% vs. 0%) in the alirocumab group.
The data are generally consistent with two previously published trials with another PCSK9 inhibitor, according to Dr. Räber. In the randomized GLAGOV trial published more than 5 years ago, evolocumab also produced about a 1% absolute reduction (P < .001) in plaque volume at the end of 78 weeks of follow-up relative to placebo.
However, that trial was limited to patients with coronary artery disease without a recent cardiovascular event. The more recent HUYGENS trial, which was presented virtually at the 2021 annual meeting of the European Society of Cardiology meeting and has not yet been published, looked at one of the endpoints also evaluated in PACMAN-AMI. In that study of 161 randomized NSTEMI patients, there was also about a doubling of fibrous cap thickness (42.7 vs. 21.5 mcm) for the PCSK9 inhibitor relative to placebo.
Clinical endpoints were not compared in either the PACMAN-AMI or HUYGENS trial.
PACMAN-AMI confirms plaque stabilization
Nevertheless, the message of plaque stabilization is important, according to Anthony N. DeMaria, MD, Founding Director of the Sulpizio Cardiovascular Center at the University of San Diego. Although he acknowledged that a 1% absolute reduction in mean plaque volume might “make you want to yawn,” he argued that this is a misreading of important changes observed in plaque physiology.
“What we have now is evidence that very low lipid levels result in plaque remodeling. The plaques might not get a whole lot smaller, but the changes are important,” he said, noting, for example, that a thicker fibrous cap and increased plaque stability “clearly plays a role in reducing risk of subsequent events.”
“You cannot help but be impressed by the relationship of lipid lowering and the favorable effect on remodeling,” he added.
The data associating PCSK9 inhibitors with protection from cardiovascular events is already extensive, according to Michael J. Blaha, MD, Director of Clinical Research for Ciccarone Center for Prevention of Cardiovascular Disease, Johns Hopkins University, Baltimore, but he called PACMAN-ACS “an extremely relevant study.”
“This provides more evidence of the mechanism of benefit, which I think is extremely important when talking to patients about the goals of therapy,” he said.
PACMAN-AMI provided a very simple take home message for Pamela B. Morris, MD, Director of Preventive Cardiology, Medical University of South Carolina, Charleston.
“This study shows that if you get LCL-C under 50 mg/dL regardless of treatment, there is a favorable remodeling effect,” Dr. Morris said. In AMI patients, the data confirm “go early and go low,” she added. “You should do whatever is necessary [go get to these lower targets].”
Dr. Räber has financial relationships with Abbott, Amgen, AstraZeneca, Boston Scientific, Biotronik, Canon, Heartflow, Medtronic, Occlutech, Regeneron, Sanofi, and Vifor. Dr. Blaha reports financial relationships with Akcea, Amgen, Bayer, Inozyme, Kaleido, Kowa, Medimmune, Novartis, Novo Nordisk, Regeneron, Roche, Sanofi, Siemens, and 89Bio. Dr. DeMaria reports no potential conflicts of interest. Dr. Morris reports a financial relationship with Amgen. The investigator-initiated trial received research grants from Infraredx, Regeneron, and Sanofi.
When the PCSK9 inhibitor alirocumab is added to high-intensity statins soon after an acute myocardial infarction (AMI), the reduction in atheroma volume is doubled at 12 months, compared with placebo, while other key signs of plaque stabilization, such as fibrous cap thickness, are also significantly and substantially improved, according to the results of the PACMAN-AMI trial.
The study is consistent with other PCSK9 inhibitor trials, supporting the concept that “we should be seeking very low levels of LDL-C in high-risk patients,” reported Lorenz Räber, MD, PhD, of Bern (Switz.) University Hospital, at the annual scientific sessions of the American College of Cardiology.
The low LCL-C target, the data from PACMAN-AMI suggest, is below 50 mg/dL, but even lower is better. When displayed graphically, the improvements in remodeling characteristics “get very steep” as levels descend below a 50 mg/dL threshold, Dr. Räber reported. This was true regardless of study arm.
In PACMAN-AMI, 300 AMI patients (with either ST-elevation or non-ST-elevaion) were randomized to 150 mg alirocumab or placebo administered by subcutaneous injection within 24 hours after an urgent percutaneous intervention (PCI) and stent placement. All patients received their assigned therapy on top of a high-intensity statin in the form of 20 mg of rosuvastatin daily.
Primary outcome was atheroma volume
The primary endpoint was atheroma volume as determined by intravenous ultrasound (IVUS), but the secondary endpoints of maximum lipid core burden, as determined by near infrared spectroscopy (NIRS), and fibrous cap thickness, as determined by optical coherence tomography (OCT), were also adequately powered, according to Dr. Räber.
The imaging measures taken at baseline were repeated in exactly the same spot after 52 weeks on treatment.
For the primary outcome of atheroma volume, the mean 2.1% reduction among those randomized to alirocumab was more than double the 0.9% reduction in the placebo group (P = .001).
The mean reduction in lipid core volume based on a maximum lipid core burden index was also more than doubled (-79.42 vs. -37.60 maxLCBI4mm; P = .006). The increase in fibrous cap thickness was not quite twofold greater but very close (62.67 vs. 33.19 mcm; P = .001).
From baseline, the relative reductions in LDL-C, which were reached about 4 weeks after starting treatment and maintained over the course of the study, were greater in the group randomized to alirocumab (-84.8% vs. -50.7%). This was expected, but the more important finding was a near linear relationship between reductions of LDL-C and each of these endpoints regardless of treatment, fully explaining the advantage of alirocumab, according to Dr. Räber.
For the addition of alirocumab, “these findings indicate incremental coronary plaque regression, lipid core reduction, and plaque stabilization, and provide a mechanistic rationale in favor of early initiation of very intensive LDL-C lower in the setting of an acute MI,” he said.
The results of the PACMAN-AMI trial were published simultaneously at the time of the ACC presentation.
Results consistent with earlier trials
Alirocumab was well tolerated. Injection site reactions (6.1% vs. 3.3%) and general allergic reactions (3.4% vs. 0%) were more common on alirocumab, but there were no significant differences between the arms of this study for serious adverse events. There were slightly more neurocognitive events (2.0 vs. 0%) and abnormal alanine transferase levels (0.7% vs. 0%) in the alirocumab group.
The data are generally consistent with two previously published trials with another PCSK9 inhibitor, according to Dr. Räber. In the randomized GLAGOV trial published more than 5 years ago, evolocumab also produced about a 1% absolute reduction (P < .001) in plaque volume at the end of 78 weeks of follow-up relative to placebo.
However, that trial was limited to patients with coronary artery disease without a recent cardiovascular event. The more recent HUYGENS trial, which was presented virtually at the 2021 annual meeting of the European Society of Cardiology meeting and has not yet been published, looked at one of the endpoints also evaluated in PACMAN-AMI. In that study of 161 randomized NSTEMI patients, there was also about a doubling of fibrous cap thickness (42.7 vs. 21.5 mcm) for the PCSK9 inhibitor relative to placebo.
Clinical endpoints were not compared in either the PACMAN-AMI or HUYGENS trial.
PACMAN-AMI confirms plaque stabilization
Nevertheless, the message of plaque stabilization is important, according to Anthony N. DeMaria, MD, Founding Director of the Sulpizio Cardiovascular Center at the University of San Diego. Although he acknowledged that a 1% absolute reduction in mean plaque volume might “make you want to yawn,” he argued that this is a misreading of important changes observed in plaque physiology.
“What we have now is evidence that very low lipid levels result in plaque remodeling. The plaques might not get a whole lot smaller, but the changes are important,” he said, noting, for example, that a thicker fibrous cap and increased plaque stability “clearly plays a role in reducing risk of subsequent events.”
“You cannot help but be impressed by the relationship of lipid lowering and the favorable effect on remodeling,” he added.
The data associating PCSK9 inhibitors with protection from cardiovascular events is already extensive, according to Michael J. Blaha, MD, Director of Clinical Research for Ciccarone Center for Prevention of Cardiovascular Disease, Johns Hopkins University, Baltimore, but he called PACMAN-ACS “an extremely relevant study.”
“This provides more evidence of the mechanism of benefit, which I think is extremely important when talking to patients about the goals of therapy,” he said.
PACMAN-AMI provided a very simple take home message for Pamela B. Morris, MD, Director of Preventive Cardiology, Medical University of South Carolina, Charleston.
“This study shows that if you get LCL-C under 50 mg/dL regardless of treatment, there is a favorable remodeling effect,” Dr. Morris said. In AMI patients, the data confirm “go early and go low,” she added. “You should do whatever is necessary [go get to these lower targets].”
Dr. Räber has financial relationships with Abbott, Amgen, AstraZeneca, Boston Scientific, Biotronik, Canon, Heartflow, Medtronic, Occlutech, Regeneron, Sanofi, and Vifor. Dr. Blaha reports financial relationships with Akcea, Amgen, Bayer, Inozyme, Kaleido, Kowa, Medimmune, Novartis, Novo Nordisk, Regeneron, Roche, Sanofi, Siemens, and 89Bio. Dr. DeMaria reports no potential conflicts of interest. Dr. Morris reports a financial relationship with Amgen. The investigator-initiated trial received research grants from Infraredx, Regeneron, and Sanofi.
When the PCSK9 inhibitor alirocumab is added to high-intensity statins soon after an acute myocardial infarction (AMI), the reduction in atheroma volume is doubled at 12 months, compared with placebo, while other key signs of plaque stabilization, such as fibrous cap thickness, are also significantly and substantially improved, according to the results of the PACMAN-AMI trial.
The study is consistent with other PCSK9 inhibitor trials, supporting the concept that “we should be seeking very low levels of LDL-C in high-risk patients,” reported Lorenz Räber, MD, PhD, of Bern (Switz.) University Hospital, at the annual scientific sessions of the American College of Cardiology.
The low LCL-C target, the data from PACMAN-AMI suggest, is below 50 mg/dL, but even lower is better. When displayed graphically, the improvements in remodeling characteristics “get very steep” as levels descend below a 50 mg/dL threshold, Dr. Räber reported. This was true regardless of study arm.
In PACMAN-AMI, 300 AMI patients (with either ST-elevation or non-ST-elevaion) were randomized to 150 mg alirocumab or placebo administered by subcutaneous injection within 24 hours after an urgent percutaneous intervention (PCI) and stent placement. All patients received their assigned therapy on top of a high-intensity statin in the form of 20 mg of rosuvastatin daily.
Primary outcome was atheroma volume
The primary endpoint was atheroma volume as determined by intravenous ultrasound (IVUS), but the secondary endpoints of maximum lipid core burden, as determined by near infrared spectroscopy (NIRS), and fibrous cap thickness, as determined by optical coherence tomography (OCT), were also adequately powered, according to Dr. Räber.
The imaging measures taken at baseline were repeated in exactly the same spot after 52 weeks on treatment.
For the primary outcome of atheroma volume, the mean 2.1% reduction among those randomized to alirocumab was more than double the 0.9% reduction in the placebo group (P = .001).
The mean reduction in lipid core volume based on a maximum lipid core burden index was also more than doubled (-79.42 vs. -37.60 maxLCBI4mm; P = .006). The increase in fibrous cap thickness was not quite twofold greater but very close (62.67 vs. 33.19 mcm; P = .001).
From baseline, the relative reductions in LDL-C, which were reached about 4 weeks after starting treatment and maintained over the course of the study, were greater in the group randomized to alirocumab (-84.8% vs. -50.7%). This was expected, but the more important finding was a near linear relationship between reductions of LDL-C and each of these endpoints regardless of treatment, fully explaining the advantage of alirocumab, according to Dr. Räber.
For the addition of alirocumab, “these findings indicate incremental coronary plaque regression, lipid core reduction, and plaque stabilization, and provide a mechanistic rationale in favor of early initiation of very intensive LDL-C lower in the setting of an acute MI,” he said.
The results of the PACMAN-AMI trial were published simultaneously at the time of the ACC presentation.
Results consistent with earlier trials
Alirocumab was well tolerated. Injection site reactions (6.1% vs. 3.3%) and general allergic reactions (3.4% vs. 0%) were more common on alirocumab, but there were no significant differences between the arms of this study for serious adverse events. There were slightly more neurocognitive events (2.0 vs. 0%) and abnormal alanine transferase levels (0.7% vs. 0%) in the alirocumab group.
The data are generally consistent with two previously published trials with another PCSK9 inhibitor, according to Dr. Räber. In the randomized GLAGOV trial published more than 5 years ago, evolocumab also produced about a 1% absolute reduction (P < .001) in plaque volume at the end of 78 weeks of follow-up relative to placebo.
However, that trial was limited to patients with coronary artery disease without a recent cardiovascular event. The more recent HUYGENS trial, which was presented virtually at the 2021 annual meeting of the European Society of Cardiology meeting and has not yet been published, looked at one of the endpoints also evaluated in PACMAN-AMI. In that study of 161 randomized NSTEMI patients, there was also about a doubling of fibrous cap thickness (42.7 vs. 21.5 mcm) for the PCSK9 inhibitor relative to placebo.
Clinical endpoints were not compared in either the PACMAN-AMI or HUYGENS trial.
PACMAN-AMI confirms plaque stabilization
Nevertheless, the message of plaque stabilization is important, according to Anthony N. DeMaria, MD, Founding Director of the Sulpizio Cardiovascular Center at the University of San Diego. Although he acknowledged that a 1% absolute reduction in mean plaque volume might “make you want to yawn,” he argued that this is a misreading of important changes observed in plaque physiology.
“What we have now is evidence that very low lipid levels result in plaque remodeling. The plaques might not get a whole lot smaller, but the changes are important,” he said, noting, for example, that a thicker fibrous cap and increased plaque stability “clearly plays a role in reducing risk of subsequent events.”
“You cannot help but be impressed by the relationship of lipid lowering and the favorable effect on remodeling,” he added.
The data associating PCSK9 inhibitors with protection from cardiovascular events is already extensive, according to Michael J. Blaha, MD, Director of Clinical Research for Ciccarone Center for Prevention of Cardiovascular Disease, Johns Hopkins University, Baltimore, but he called PACMAN-ACS “an extremely relevant study.”
“This provides more evidence of the mechanism of benefit, which I think is extremely important when talking to patients about the goals of therapy,” he said.
PACMAN-AMI provided a very simple take home message for Pamela B. Morris, MD, Director of Preventive Cardiology, Medical University of South Carolina, Charleston.
“This study shows that if you get LCL-C under 50 mg/dL regardless of treatment, there is a favorable remodeling effect,” Dr. Morris said. In AMI patients, the data confirm “go early and go low,” she added. “You should do whatever is necessary [go get to these lower targets].”
Dr. Räber has financial relationships with Abbott, Amgen, AstraZeneca, Boston Scientific, Biotronik, Canon, Heartflow, Medtronic, Occlutech, Regeneron, Sanofi, and Vifor. Dr. Blaha reports financial relationships with Akcea, Amgen, Bayer, Inozyme, Kaleido, Kowa, Medimmune, Novartis, Novo Nordisk, Regeneron, Roche, Sanofi, Siemens, and 89Bio. Dr. DeMaria reports no potential conflicts of interest. Dr. Morris reports a financial relationship with Amgen. The investigator-initiated trial received research grants from Infraredx, Regeneron, and Sanofi.
FROM ACC 2022
FDA approves leadless, single-chamber pacemaker system
The Food and Drug Administration has granted approval to Abbott’s Aveir leadless, single-chamber pacemaker system for patients with bradycardia.
In a press release, Abbott said the device has a unique mapping capability that allows interventionists implanting the device to measure electrical signals within the heart to determine the correct placement before final implantation. Aveir is implanted directly into the right ventricle via a catheter.
The company also said Aveir has a battery life that’s up to twice as long as other commercially available leadless pacemakers when following International Association for Standardization (ISO) standard settings. And the device can be retrieved if necessary, the press release said.
“Leadless pacemakers address known complications associated with traditional pacemakers,” Rahul Doshi, MD, director of electrophysiology at Honor Health in Scottsdale, Ariz., said in the press release. “In addition, the Aveir leadless pacemaker brings unique innovations we’ve been seeking, such as the ability to ensure electrical performance before we commit to placement.”
Investigators of the LEADLESS II phase 2 study reported last year on what they called “key design improvements” of the Aveir device compared to the first leadless pacemaker, the discontinued Nanostim. They included a 12% longer battery life, a shorter and wider form factor, a modified docking button that allows for retrievability, a modified delivery system, and an application-specific integrated circuit chip that can support a dual-chamber pacing system in the future.
The study reported that 96% of the 200 enrolled patients met the primary safety endpoint of no serious device-related adverse events at 6 weeks after implantation. A similar percentage achieved therapeutic pacing and sensing amplitude.
The study also reported that interventionists accurately positioned Aveir the first time or with a single repositioning in 96% of cases.
The Food and Drug Administration has granted approval to Abbott’s Aveir leadless, single-chamber pacemaker system for patients with bradycardia.
In a press release, Abbott said the device has a unique mapping capability that allows interventionists implanting the device to measure electrical signals within the heart to determine the correct placement before final implantation. Aveir is implanted directly into the right ventricle via a catheter.
The company also said Aveir has a battery life that’s up to twice as long as other commercially available leadless pacemakers when following International Association for Standardization (ISO) standard settings. And the device can be retrieved if necessary, the press release said.
“Leadless pacemakers address known complications associated with traditional pacemakers,” Rahul Doshi, MD, director of electrophysiology at Honor Health in Scottsdale, Ariz., said in the press release. “In addition, the Aveir leadless pacemaker brings unique innovations we’ve been seeking, such as the ability to ensure electrical performance before we commit to placement.”
Investigators of the LEADLESS II phase 2 study reported last year on what they called “key design improvements” of the Aveir device compared to the first leadless pacemaker, the discontinued Nanostim. They included a 12% longer battery life, a shorter and wider form factor, a modified docking button that allows for retrievability, a modified delivery system, and an application-specific integrated circuit chip that can support a dual-chamber pacing system in the future.
The study reported that 96% of the 200 enrolled patients met the primary safety endpoint of no serious device-related adverse events at 6 weeks after implantation. A similar percentage achieved therapeutic pacing and sensing amplitude.
The study also reported that interventionists accurately positioned Aveir the first time or with a single repositioning in 96% of cases.
The Food and Drug Administration has granted approval to Abbott’s Aveir leadless, single-chamber pacemaker system for patients with bradycardia.
In a press release, Abbott said the device has a unique mapping capability that allows interventionists implanting the device to measure electrical signals within the heart to determine the correct placement before final implantation. Aveir is implanted directly into the right ventricle via a catheter.
The company also said Aveir has a battery life that’s up to twice as long as other commercially available leadless pacemakers when following International Association for Standardization (ISO) standard settings. And the device can be retrieved if necessary, the press release said.
“Leadless pacemakers address known complications associated with traditional pacemakers,” Rahul Doshi, MD, director of electrophysiology at Honor Health in Scottsdale, Ariz., said in the press release. “In addition, the Aveir leadless pacemaker brings unique innovations we’ve been seeking, such as the ability to ensure electrical performance before we commit to placement.”
Investigators of the LEADLESS II phase 2 study reported last year on what they called “key design improvements” of the Aveir device compared to the first leadless pacemaker, the discontinued Nanostim. They included a 12% longer battery life, a shorter and wider form factor, a modified docking button that allows for retrievability, a modified delivery system, and an application-specific integrated circuit chip that can support a dual-chamber pacing system in the future.
The study reported that 96% of the 200 enrolled patients met the primary safety endpoint of no serious device-related adverse events at 6 weeks after implantation. A similar percentage achieved therapeutic pacing and sensing amplitude.
The study also reported that interventionists accurately positioned Aveir the first time or with a single repositioning in 96% of cases.