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Welcome to HM19
Welcome to Hospital Medicine 2019 (HM19), the largest conference of the year specifically focused on hospital medicine. The Society of Hospital Medicine is proud that HM19 brings together a broad range of stakeholders in hospital medicine, including physicians of many specialties, advanced practice providers, administrators, pharmacists, C-suite executives, recruiters, and educators. Your decision to join your colleagues at HM19 demonstrates your commitment not only to the specialty of hospital medicine but also to the patients you serve.
This year’s renowned speakers will present important sessions addressing the rapidly evolving health care landscape. To open the main meeting on March 25, Marc Harrison, MD, president and CEO of Intermountain Healthcare, will present his featured address on the future of health care. You will also hear from the president of SHM, Nasim Afsar, MD, MBA, SFHM, about the state of hospital medicine.
On March 26, we are proud to welcome Tait Shanafelt, MD, from Stanford, who will talk about strategies to prevent burnout and create resilient hospitalists.
On March 25 and 26, be sure to attend one of SHM’s Special Interest Forums, where you can choose to network and connect with other hospitalists interested in the same areas you are. There are more than 30 forums from which to choose. On March 26, SHM will open the International Hospital Medicine Lounge. We hope to welcome more than 100 hospitalists from around the world to HM19.
Please make sure to download the HM19 At Hand meeting app, a wonderful resource for every HM19 attendee that puts the conference at your fingertips. Create an individualized conference experience from your smartphone, tablet, or laptop.
Don’t miss the opportunity to meet one-on-one with members of SHM’s Board of Directors, who will be available in the SHM Pavilion during scheduled visit times. Please consult the Meet the Board schedule in the HM19 At Hand app for further information.
On behalf of the SHM Board of Directors and staff, welcome to HM19 and to the Gaylord at National Harbor. Through this meeting’s rich selection of educational opportunities, research offerings, and networking events, SHM continues to further its mission to promote excellence in the practice of hospital medicine. SHM remains at the forefront of health care today, empowering hospitalists and transforming patient care.
Dr. Wellikson is CEO of SHM.
Welcome to Hospital Medicine 2019 (HM19), the largest conference of the year specifically focused on hospital medicine. The Society of Hospital Medicine is proud that HM19 brings together a broad range of stakeholders in hospital medicine, including physicians of many specialties, advanced practice providers, administrators, pharmacists, C-suite executives, recruiters, and educators. Your decision to join your colleagues at HM19 demonstrates your commitment not only to the specialty of hospital medicine but also to the patients you serve.
This year’s renowned speakers will present important sessions addressing the rapidly evolving health care landscape. To open the main meeting on March 25, Marc Harrison, MD, president and CEO of Intermountain Healthcare, will present his featured address on the future of health care. You will also hear from the president of SHM, Nasim Afsar, MD, MBA, SFHM, about the state of hospital medicine.
On March 26, we are proud to welcome Tait Shanafelt, MD, from Stanford, who will talk about strategies to prevent burnout and create resilient hospitalists.
On March 25 and 26, be sure to attend one of SHM’s Special Interest Forums, where you can choose to network and connect with other hospitalists interested in the same areas you are. There are more than 30 forums from which to choose. On March 26, SHM will open the International Hospital Medicine Lounge. We hope to welcome more than 100 hospitalists from around the world to HM19.
Please make sure to download the HM19 At Hand meeting app, a wonderful resource for every HM19 attendee that puts the conference at your fingertips. Create an individualized conference experience from your smartphone, tablet, or laptop.
Don’t miss the opportunity to meet one-on-one with members of SHM’s Board of Directors, who will be available in the SHM Pavilion during scheduled visit times. Please consult the Meet the Board schedule in the HM19 At Hand app for further information.
On behalf of the SHM Board of Directors and staff, welcome to HM19 and to the Gaylord at National Harbor. Through this meeting’s rich selection of educational opportunities, research offerings, and networking events, SHM continues to further its mission to promote excellence in the practice of hospital medicine. SHM remains at the forefront of health care today, empowering hospitalists and transforming patient care.
Dr. Wellikson is CEO of SHM.
Welcome to Hospital Medicine 2019 (HM19), the largest conference of the year specifically focused on hospital medicine. The Society of Hospital Medicine is proud that HM19 brings together a broad range of stakeholders in hospital medicine, including physicians of many specialties, advanced practice providers, administrators, pharmacists, C-suite executives, recruiters, and educators. Your decision to join your colleagues at HM19 demonstrates your commitment not only to the specialty of hospital medicine but also to the patients you serve.
This year’s renowned speakers will present important sessions addressing the rapidly evolving health care landscape. To open the main meeting on March 25, Marc Harrison, MD, president and CEO of Intermountain Healthcare, will present his featured address on the future of health care. You will also hear from the president of SHM, Nasim Afsar, MD, MBA, SFHM, about the state of hospital medicine.
On March 26, we are proud to welcome Tait Shanafelt, MD, from Stanford, who will talk about strategies to prevent burnout and create resilient hospitalists.
On March 25 and 26, be sure to attend one of SHM’s Special Interest Forums, where you can choose to network and connect with other hospitalists interested in the same areas you are. There are more than 30 forums from which to choose. On March 26, SHM will open the International Hospital Medicine Lounge. We hope to welcome more than 100 hospitalists from around the world to HM19.
Please make sure to download the HM19 At Hand meeting app, a wonderful resource for every HM19 attendee that puts the conference at your fingertips. Create an individualized conference experience from your smartphone, tablet, or laptop.
Don’t miss the opportunity to meet one-on-one with members of SHM’s Board of Directors, who will be available in the SHM Pavilion during scheduled visit times. Please consult the Meet the Board schedule in the HM19 At Hand app for further information.
On behalf of the SHM Board of Directors and staff, welcome to HM19 and to the Gaylord at National Harbor. Through this meeting’s rich selection of educational opportunities, research offerings, and networking events, SHM continues to further its mission to promote excellence in the practice of hospital medicine. SHM remains at the forefront of health care today, empowering hospitalists and transforming patient care.
Dr. Wellikson is CEO of SHM.
Quality, value take center stage
Dr. Marc Harrison of Intermountain Healthcare
The opening keynote at HM19 features one of the more prominent physician executives in the United States, speaking about a subject of great interest to hospitalists – how to increase the quality and value of care.
Dr. Marc Harrison is president and CEO of Intermountain Healthcare, based in Salt Lake City, the largest health care provider in the Intermountain West. Trained as a pediatric critical care physician, Dr. Harrison ranked second on the 2018 Modern Healthcare list of “Most Influential Physician Executives and Leaders.” His previous experience has included service as CEO of Cleveland Clinic Abu Dhabi, chief of international business development at Cleveland Clinic, and chief medical operations officer at Cleveland Clinic.
As the HM19 keynote speaker, Dr. Harrison said he will speak about how to move U.S. health care toward a model that adds more value for people, in the form of not only better quality and more accessible and affordable health care but overall healthier people, as well.
“I will talk about some of the market forces that are affecting health care and why we’re in the health care environment we’re in today,” Dr. Harrison said. “The cost of health care is unsustainable and unaffordable for people, and I want to talk about how Intermountain Healthcare is moving to a population-health and value-based model.”
Dr. Harrison said he wants to explain to hospitalists how Intermountain Healthcare is positioning itself to be sustainable in the future.
“I’ll talk specifically about how hospitalists are positioned to impact health care delivery,” he said. “At Intermountain Healthcare, we have recently restructured in two streams of businesses: Specialty-based care, which is our hospital-type services and specialist services providing high-level acuity care, and community-based care, which is really the services that are designed to keep people healthy and out of our hospitals as much as possible.”
According to Dr. Harrison, hospitalists at Intermountain Healthcare “live right at that intersection of those two streams of care, so they’re uniquely positioned to influence both health care quality and the cost of health care, as well as keeping people healthy.”
He hopes HM19 attendees will leave his keynote with an understanding of the need to be proactive and responsive in this new health care environment.
“They’re going to have to be courageous, bold, and agile to change,” Dr. Harrison said. “They need to always be thinking about how to create more value for their patients, including the experience that they provide not only for patients but among colleagues within their group, and then within their health system.”
The need to transform with the challenging environment we’re in is just one part, he added. “You’ve got to take that philosophy and apply it to the budget constraints that health care systems are facing. You have to implement a model that allows front-line caregivers to contribute their best thinking and their best ideas so that the whole system can progress forward together. Those who are closest to the work on the front lines can contribute to innovation, but they have to be realistic – considering their budget restraints and the pressures that they’re facing.”
The key for Dr. Harrison is that there really is a need for change and that, in the country as a whole, there exist perverse incentives that make it easy to not do the right thing.
“We need to totally rethink the way that we look at health care so that the focus is keeping people well, only doing those things that add value so that care can become affordable,” Dr. Harrison said. “One of the things that voters said when they came out of the polls in November 2018 was that they were concerned about the cost of health care. For those of us working in health care to ignore that is just wrong – it’s something that we need to pay attention to and do something about.”
Influencing Lives Earlier, More Effectively and More Affordably
Marc Harrison, MD
Monday, 8:40 a.m. – 9:30 a.m.
Potomac ABCD
Dr. Marc Harrison of Intermountain Healthcare
Dr. Marc Harrison of Intermountain Healthcare
The opening keynote at HM19 features one of the more prominent physician executives in the United States, speaking about a subject of great interest to hospitalists – how to increase the quality and value of care.
Dr. Marc Harrison is president and CEO of Intermountain Healthcare, based in Salt Lake City, the largest health care provider in the Intermountain West. Trained as a pediatric critical care physician, Dr. Harrison ranked second on the 2018 Modern Healthcare list of “Most Influential Physician Executives and Leaders.” His previous experience has included service as CEO of Cleveland Clinic Abu Dhabi, chief of international business development at Cleveland Clinic, and chief medical operations officer at Cleveland Clinic.
As the HM19 keynote speaker, Dr. Harrison said he will speak about how to move U.S. health care toward a model that adds more value for people, in the form of not only better quality and more accessible and affordable health care but overall healthier people, as well.
“I will talk about some of the market forces that are affecting health care and why we’re in the health care environment we’re in today,” Dr. Harrison said. “The cost of health care is unsustainable and unaffordable for people, and I want to talk about how Intermountain Healthcare is moving to a population-health and value-based model.”
Dr. Harrison said he wants to explain to hospitalists how Intermountain Healthcare is positioning itself to be sustainable in the future.
“I’ll talk specifically about how hospitalists are positioned to impact health care delivery,” he said. “At Intermountain Healthcare, we have recently restructured in two streams of businesses: Specialty-based care, which is our hospital-type services and specialist services providing high-level acuity care, and community-based care, which is really the services that are designed to keep people healthy and out of our hospitals as much as possible.”
According to Dr. Harrison, hospitalists at Intermountain Healthcare “live right at that intersection of those two streams of care, so they’re uniquely positioned to influence both health care quality and the cost of health care, as well as keeping people healthy.”
He hopes HM19 attendees will leave his keynote with an understanding of the need to be proactive and responsive in this new health care environment.
“They’re going to have to be courageous, bold, and agile to change,” Dr. Harrison said. “They need to always be thinking about how to create more value for their patients, including the experience that they provide not only for patients but among colleagues within their group, and then within their health system.”
The need to transform with the challenging environment we’re in is just one part, he added. “You’ve got to take that philosophy and apply it to the budget constraints that health care systems are facing. You have to implement a model that allows front-line caregivers to contribute their best thinking and their best ideas so that the whole system can progress forward together. Those who are closest to the work on the front lines can contribute to innovation, but they have to be realistic – considering their budget restraints and the pressures that they’re facing.”
The key for Dr. Harrison is that there really is a need for change and that, in the country as a whole, there exist perverse incentives that make it easy to not do the right thing.
“We need to totally rethink the way that we look at health care so that the focus is keeping people well, only doing those things that add value so that care can become affordable,” Dr. Harrison said. “One of the things that voters said when they came out of the polls in November 2018 was that they were concerned about the cost of health care. For those of us working in health care to ignore that is just wrong – it’s something that we need to pay attention to and do something about.”
Influencing Lives Earlier, More Effectively and More Affordably
Marc Harrison, MD
Monday, 8:40 a.m. – 9:30 a.m.
Potomac ABCD
The opening keynote at HM19 features one of the more prominent physician executives in the United States, speaking about a subject of great interest to hospitalists – how to increase the quality and value of care.
Dr. Marc Harrison is president and CEO of Intermountain Healthcare, based in Salt Lake City, the largest health care provider in the Intermountain West. Trained as a pediatric critical care physician, Dr. Harrison ranked second on the 2018 Modern Healthcare list of “Most Influential Physician Executives and Leaders.” His previous experience has included service as CEO of Cleveland Clinic Abu Dhabi, chief of international business development at Cleveland Clinic, and chief medical operations officer at Cleveland Clinic.
As the HM19 keynote speaker, Dr. Harrison said he will speak about how to move U.S. health care toward a model that adds more value for people, in the form of not only better quality and more accessible and affordable health care but overall healthier people, as well.
“I will talk about some of the market forces that are affecting health care and why we’re in the health care environment we’re in today,” Dr. Harrison said. “The cost of health care is unsustainable and unaffordable for people, and I want to talk about how Intermountain Healthcare is moving to a population-health and value-based model.”
Dr. Harrison said he wants to explain to hospitalists how Intermountain Healthcare is positioning itself to be sustainable in the future.
“I’ll talk specifically about how hospitalists are positioned to impact health care delivery,” he said. “At Intermountain Healthcare, we have recently restructured in two streams of businesses: Specialty-based care, which is our hospital-type services and specialist services providing high-level acuity care, and community-based care, which is really the services that are designed to keep people healthy and out of our hospitals as much as possible.”
According to Dr. Harrison, hospitalists at Intermountain Healthcare “live right at that intersection of those two streams of care, so they’re uniquely positioned to influence both health care quality and the cost of health care, as well as keeping people healthy.”
He hopes HM19 attendees will leave his keynote with an understanding of the need to be proactive and responsive in this new health care environment.
“They’re going to have to be courageous, bold, and agile to change,” Dr. Harrison said. “They need to always be thinking about how to create more value for their patients, including the experience that they provide not only for patients but among colleagues within their group, and then within their health system.”
The need to transform with the challenging environment we’re in is just one part, he added. “You’ve got to take that philosophy and apply it to the budget constraints that health care systems are facing. You have to implement a model that allows front-line caregivers to contribute their best thinking and their best ideas so that the whole system can progress forward together. Those who are closest to the work on the front lines can contribute to innovation, but they have to be realistic – considering their budget restraints and the pressures that they’re facing.”
The key for Dr. Harrison is that there really is a need for change and that, in the country as a whole, there exist perverse incentives that make it easy to not do the right thing.
“We need to totally rethink the way that we look at health care so that the focus is keeping people well, only doing those things that add value so that care can become affordable,” Dr. Harrison said. “One of the things that voters said when they came out of the polls in November 2018 was that they were concerned about the cost of health care. For those of us working in health care to ignore that is just wrong – it’s something that we need to pay attention to and do something about.”
Influencing Lives Earlier, More Effectively and More Affordably
Marc Harrison, MD
Monday, 8:40 a.m. – 9:30 a.m.
Potomac ABCD
FDA approves another trastuzumab biosimilar for HER2-positive breast cancer, gastric cancer
The Food and Drug Administration has approved Trazimera (trastuzumab-qyyp), a biosimilar of Herceptin (trastuzumab), for the treatment of HER2-positive breast cancer and HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.
FDA approval was based on a review of a comprehensive data package, which included results from the REFLECTIONS B327-02 trial. In this trial, Trazimera was found to have clinical equivalence with trastuzumab in the first-line treatment setting in patients with HER2-positive metastatic breast cancer.
The most common adverse events associated with Trazimera in patients with breast cancer include fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cell counts, and muscle pain. For patients with metastatic adenocarcinoma, the most common adverse events include low white and red blood cell counts; diarrhea; fatigue; swelling of the mouth lining, mucous membranes, nose, or throat; weight loss; upper respiratory tract infections; fever; low platelet counts; and change in taste.
“Approximately 15-30% of breast cancers and 10-30% of gastric cancers are HER2-positive, which is associated with aggressive disease and poor prognoses for patients. With the availability of biosimilars like Trazimera in the U.S., oncologists will have additional treatment options to choose from, which may help provide patients with greater access to the medicines they need,” Mark Pegram, MD, director of the breast oncology program at the Stanford Women’s Cancer Center at Stanford (Calif.) University, said in the press release.
Find the full press release on the Pfizer website.
The Food and Drug Administration has approved Trazimera (trastuzumab-qyyp), a biosimilar of Herceptin (trastuzumab), for the treatment of HER2-positive breast cancer and HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.
FDA approval was based on a review of a comprehensive data package, which included results from the REFLECTIONS B327-02 trial. In this trial, Trazimera was found to have clinical equivalence with trastuzumab in the first-line treatment setting in patients with HER2-positive metastatic breast cancer.
The most common adverse events associated with Trazimera in patients with breast cancer include fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cell counts, and muscle pain. For patients with metastatic adenocarcinoma, the most common adverse events include low white and red blood cell counts; diarrhea; fatigue; swelling of the mouth lining, mucous membranes, nose, or throat; weight loss; upper respiratory tract infections; fever; low platelet counts; and change in taste.
“Approximately 15-30% of breast cancers and 10-30% of gastric cancers are HER2-positive, which is associated with aggressive disease and poor prognoses for patients. With the availability of biosimilars like Trazimera in the U.S., oncologists will have additional treatment options to choose from, which may help provide patients with greater access to the medicines they need,” Mark Pegram, MD, director of the breast oncology program at the Stanford Women’s Cancer Center at Stanford (Calif.) University, said in the press release.
Find the full press release on the Pfizer website.
The Food and Drug Administration has approved Trazimera (trastuzumab-qyyp), a biosimilar of Herceptin (trastuzumab), for the treatment of HER2-positive breast cancer and HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.
FDA approval was based on a review of a comprehensive data package, which included results from the REFLECTIONS B327-02 trial. In this trial, Trazimera was found to have clinical equivalence with trastuzumab in the first-line treatment setting in patients with HER2-positive metastatic breast cancer.
The most common adverse events associated with Trazimera in patients with breast cancer include fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cell counts, and muscle pain. For patients with metastatic adenocarcinoma, the most common adverse events include low white and red blood cell counts; diarrhea; fatigue; swelling of the mouth lining, mucous membranes, nose, or throat; weight loss; upper respiratory tract infections; fever; low platelet counts; and change in taste.
“Approximately 15-30% of breast cancers and 10-30% of gastric cancers are HER2-positive, which is associated with aggressive disease and poor prognoses for patients. With the availability of biosimilars like Trazimera in the U.S., oncologists will have additional treatment options to choose from, which may help provide patients with greater access to the medicines they need,” Mark Pegram, MD, director of the breast oncology program at the Stanford Women’s Cancer Center at Stanford (Calif.) University, said in the press release.
Find the full press release on the Pfizer website.
Which comorbidities most diminish quality of life in patients with MS?
DALLAS – (MS), according to an analysis presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. In addition, comorbidities account for about 18% of the variance in health-related quality of life, and a higher number of comorbidities correlates with lower health-related quality of life in a “clear dose–response” manner, the researchers said.
The “magnitude of effect emphasizes the need for recognition and appropriate management of comorbidities,” said presenting author Lara Marie Pangan Lo, a researcher at Menzies Institute for Medical Research at the University of Tasmania, Australia, and her research colleagues. “The individual effect sizes may assist with the prioritizing of comorbidities that require more or less aggressive treatment in order to minimize” their impact.
Prior studies have found that patients with MS have lower health-related quality of life, compared with the general population, and that comorbidities affect patients’ quality of life, but few studies have looked at the effects of individual comorbidities on quality of life, Ms. Lo and her colleagues said. To examine the total impact and relative importance of comorbidities on psychosocial, physical, and overall health-related quality of life in people with MS, the investigators analyzed survey data from 902 participants in the survey-based Australian MS Longitudinal Study. They used linear regression and dominance analysis to assess relationships between comorbidities and participants’ Assessment of Quality of Life-8 Dimensions scores, which can range from 0 (death) to 1 (perfect health).
The predicted health-related quality of life for patients without comorbidities was 0.74. After the researchers adjusted for age, sex, and education, they found that systemic lupus erythematosus (reported by 1.56% of patients), depression (41.25%), hyperthyroidism (3.01%), and anxiety (38.35%) were associated with the greatest estimated decreases in health-related quality of life (–0.16, –0.15, –0.12, and –0.11, respectively). Depression and anxiety had the largest effect on psychosocial health–related quality of life, whereas systemic lupus erythematosus, rheumatoid arthritis, and hyperthyroidism had the largest impact on physical health–related quality of life. Other comorbidities that significantly correlated with quality of life included osteoporosis, type 2 diabetes, migraine, and inflammatory bowel disease.
The study was supported by Multiple Sclerosis Research Australia. The authors had no relevant disclosures.
SOURCE: Lo LMP et al. ACTRIMS Forum 2019, Abstract 80.
DALLAS – (MS), according to an analysis presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. In addition, comorbidities account for about 18% of the variance in health-related quality of life, and a higher number of comorbidities correlates with lower health-related quality of life in a “clear dose–response” manner, the researchers said.
The “magnitude of effect emphasizes the need for recognition and appropriate management of comorbidities,” said presenting author Lara Marie Pangan Lo, a researcher at Menzies Institute for Medical Research at the University of Tasmania, Australia, and her research colleagues. “The individual effect sizes may assist with the prioritizing of comorbidities that require more or less aggressive treatment in order to minimize” their impact.
Prior studies have found that patients with MS have lower health-related quality of life, compared with the general population, and that comorbidities affect patients’ quality of life, but few studies have looked at the effects of individual comorbidities on quality of life, Ms. Lo and her colleagues said. To examine the total impact and relative importance of comorbidities on psychosocial, physical, and overall health-related quality of life in people with MS, the investigators analyzed survey data from 902 participants in the survey-based Australian MS Longitudinal Study. They used linear regression and dominance analysis to assess relationships between comorbidities and participants’ Assessment of Quality of Life-8 Dimensions scores, which can range from 0 (death) to 1 (perfect health).
The predicted health-related quality of life for patients without comorbidities was 0.74. After the researchers adjusted for age, sex, and education, they found that systemic lupus erythematosus (reported by 1.56% of patients), depression (41.25%), hyperthyroidism (3.01%), and anxiety (38.35%) were associated with the greatest estimated decreases in health-related quality of life (–0.16, –0.15, –0.12, and –0.11, respectively). Depression and anxiety had the largest effect on psychosocial health–related quality of life, whereas systemic lupus erythematosus, rheumatoid arthritis, and hyperthyroidism had the largest impact on physical health–related quality of life. Other comorbidities that significantly correlated with quality of life included osteoporosis, type 2 diabetes, migraine, and inflammatory bowel disease.
The study was supported by Multiple Sclerosis Research Australia. The authors had no relevant disclosures.
SOURCE: Lo LMP et al. ACTRIMS Forum 2019, Abstract 80.
DALLAS – (MS), according to an analysis presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. In addition, comorbidities account for about 18% of the variance in health-related quality of life, and a higher number of comorbidities correlates with lower health-related quality of life in a “clear dose–response” manner, the researchers said.
The “magnitude of effect emphasizes the need for recognition and appropriate management of comorbidities,” said presenting author Lara Marie Pangan Lo, a researcher at Menzies Institute for Medical Research at the University of Tasmania, Australia, and her research colleagues. “The individual effect sizes may assist with the prioritizing of comorbidities that require more or less aggressive treatment in order to minimize” their impact.
Prior studies have found that patients with MS have lower health-related quality of life, compared with the general population, and that comorbidities affect patients’ quality of life, but few studies have looked at the effects of individual comorbidities on quality of life, Ms. Lo and her colleagues said. To examine the total impact and relative importance of comorbidities on psychosocial, physical, and overall health-related quality of life in people with MS, the investigators analyzed survey data from 902 participants in the survey-based Australian MS Longitudinal Study. They used linear regression and dominance analysis to assess relationships between comorbidities and participants’ Assessment of Quality of Life-8 Dimensions scores, which can range from 0 (death) to 1 (perfect health).
The predicted health-related quality of life for patients without comorbidities was 0.74. After the researchers adjusted for age, sex, and education, they found that systemic lupus erythematosus (reported by 1.56% of patients), depression (41.25%), hyperthyroidism (3.01%), and anxiety (38.35%) were associated with the greatest estimated decreases in health-related quality of life (–0.16, –0.15, –0.12, and –0.11, respectively). Depression and anxiety had the largest effect on psychosocial health–related quality of life, whereas systemic lupus erythematosus, rheumatoid arthritis, and hyperthyroidism had the largest impact on physical health–related quality of life. Other comorbidities that significantly correlated with quality of life included osteoporosis, type 2 diabetes, migraine, and inflammatory bowel disease.
The study was supported by Multiple Sclerosis Research Australia. The authors had no relevant disclosures.
SOURCE: Lo LMP et al. ACTRIMS Forum 2019, Abstract 80.
REPORTING FROM ACTRIMS FORUM 2019
An update on treatment of depression
Paul is 13-year-old male in seventh grade with a history of inattentive ADHD and a positive family history of depression and anxiety in his mother. He always has had a few friends, but recently they have not wanted to hang out with him; he feels like people are ignoring him. For the past 2 months, Paul’s mood has gotten very low. He feels sad and also bored because he is not enjoying anything anymore. He feels as though he is “a loser,” and as though nothing will ever get better. His grades have dropped. He has thoughts of wishing he were dead, although he has no specific plan and says he wouldn’t do it because he doesn’t want to hurt his parents. He is looking at his phone at night and gets to bed late, then doesn’t want to get up in the morning. He sleeps until noon on weekends. Appetite is increased. He doesn’t have energy to do things on the weekends.
Discussion
Paul clearly meets diagnostic criteria for depression. He feels sad and has lost pleasure in activities he used to enjoy. He has negative, hopeless thoughts, and vague thoughts of death although no specific plans. He has vegetative signs of depression with increased appetite and sleep; he likely has worse concentration than usual, given that his grades have dropped. Energy is low.
Meta-analyses have demonstrated the efficacy of SSRIs (fluoxetine, sertraline, citalopram, escitalopram) as well as venlafaxine, mirtazapine, and nefazodone with small to very small effect sizes.1 A large placebo effect is seen in many of these studies, correlating with the number of study sites – a feature of many industry-sponsored studies.
John Walkup, MD, a leading researcher on both medication and psychotherapeutic interventions in children’s mood disorders, has pointed out that the quality of industry-sponsored studies (vs. National Institute of Mental Health–sponsored studies) is likely lower, with more pressure to get in large numbers of patients in a short period of time, less trained investigators leading to less clear-cut diagnoses, and other sources of bias.2 This raises the question of whether we should weight NIMH-sponsored studies more heavily in meta-analyses.
A second factor to consider is the risk of harm, and a significant issue here is the question of whether suicidal ideation is increased among those patients taking SSRIs. Meta-analyses from the late 2000s, which balanced the number needed to treat vs. the number needed to harm, judged that for children under age 13 years, fluoxetine was the only antidepressant that was worth the cost-benefit ratio. However, in the past several years there has been a major improvement in the assessment of suicidal ideation in the form of the Columbia Suicide Severity Rating Scale, a standardized method of assessing the presence and significance of suicidal thoughts and behaviors. Studies that have used this assessment have found no significant increase in suicidal ideation with SSRIs vs. placebo.
The takeaway here is that the SSRIs can work, with fluoxetine, sertraline, and escitalopram leading the evidence, and that with refinements of the assessment they do not appear to increase the risk of suicidal ideation.3 Of course, it remains important to discuss this issue with families.
Psychotherapy is the other major treatment for depression. Cognitive behavioral therapy (CBT) and Interpersonal therapy (IPT) for adolescents show effectiveness in teens.4 Recent meta-analyses have gotten stronger through the use of stringent quality criteria and the inclusion of negative studies; these therapies continue to be considered well established. It is worthwhile to talk to therapists in your community to understand what type of treatment they offer. If you are hiring therapists to be embedded in your practice, look for people who have been trained in CBT or IPT. It is particularly helpful to know whether therapists have seen patients using CBT or IPT while getting supervision in these modalities.
CBT and IPT are different. CBT puts an emphasis on the thought-feeling-behavior triangle while IPT focuses more on relationships. Someone who has tried one and has not benefited nevertheless may benefit from the other.
Working with your patients to choose what type of psychotherapy modality for depression they would like is particularly effective.
Finally, be aware of how the environment may be affecting your patient. School issues related to peers, learning style or disabilities, and organization have a major effect on teens. In this case, Paul is looking at his phone nightly, which may be affecting both his sleep and self-esteem. Family issues continue to play a key role.
Paul was referred for CBT therapy, which was moderately helpful. After a few months, sertraline was added with further improvement. A key element in fully resolving Paul’s depression was his becoming involved in the drama club, which gave him the chance to meet a group of peers who shared his interests.
Dr. Hall is assistant professor of psychiatry and pediatrics at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at [email protected].
References
1. JAMA. 2007 Apr 18;297(15):1683-96.
2. Am J Psychiatry. 2017 May 1;174(5):430-7.
3. J Child Adolesc Psychopharmacol. 2018. doi: 10.1089/cap.2017.0174.
4. J Clin Child Adolesc Psychol. 2017 Jan-Feb;46(1):11-43.
Paul is 13-year-old male in seventh grade with a history of inattentive ADHD and a positive family history of depression and anxiety in his mother. He always has had a few friends, but recently they have not wanted to hang out with him; he feels like people are ignoring him. For the past 2 months, Paul’s mood has gotten very low. He feels sad and also bored because he is not enjoying anything anymore. He feels as though he is “a loser,” and as though nothing will ever get better. His grades have dropped. He has thoughts of wishing he were dead, although he has no specific plan and says he wouldn’t do it because he doesn’t want to hurt his parents. He is looking at his phone at night and gets to bed late, then doesn’t want to get up in the morning. He sleeps until noon on weekends. Appetite is increased. He doesn’t have energy to do things on the weekends.
Discussion
Paul clearly meets diagnostic criteria for depression. He feels sad and has lost pleasure in activities he used to enjoy. He has negative, hopeless thoughts, and vague thoughts of death although no specific plans. He has vegetative signs of depression with increased appetite and sleep; he likely has worse concentration than usual, given that his grades have dropped. Energy is low.
Meta-analyses have demonstrated the efficacy of SSRIs (fluoxetine, sertraline, citalopram, escitalopram) as well as venlafaxine, mirtazapine, and nefazodone with small to very small effect sizes.1 A large placebo effect is seen in many of these studies, correlating with the number of study sites – a feature of many industry-sponsored studies.
John Walkup, MD, a leading researcher on both medication and psychotherapeutic interventions in children’s mood disorders, has pointed out that the quality of industry-sponsored studies (vs. National Institute of Mental Health–sponsored studies) is likely lower, with more pressure to get in large numbers of patients in a short period of time, less trained investigators leading to less clear-cut diagnoses, and other sources of bias.2 This raises the question of whether we should weight NIMH-sponsored studies more heavily in meta-analyses.
A second factor to consider is the risk of harm, and a significant issue here is the question of whether suicidal ideation is increased among those patients taking SSRIs. Meta-analyses from the late 2000s, which balanced the number needed to treat vs. the number needed to harm, judged that for children under age 13 years, fluoxetine was the only antidepressant that was worth the cost-benefit ratio. However, in the past several years there has been a major improvement in the assessment of suicidal ideation in the form of the Columbia Suicide Severity Rating Scale, a standardized method of assessing the presence and significance of suicidal thoughts and behaviors. Studies that have used this assessment have found no significant increase in suicidal ideation with SSRIs vs. placebo.
The takeaway here is that the SSRIs can work, with fluoxetine, sertraline, and escitalopram leading the evidence, and that with refinements of the assessment they do not appear to increase the risk of suicidal ideation.3 Of course, it remains important to discuss this issue with families.
Psychotherapy is the other major treatment for depression. Cognitive behavioral therapy (CBT) and Interpersonal therapy (IPT) for adolescents show effectiveness in teens.4 Recent meta-analyses have gotten stronger through the use of stringent quality criteria and the inclusion of negative studies; these therapies continue to be considered well established. It is worthwhile to talk to therapists in your community to understand what type of treatment they offer. If you are hiring therapists to be embedded in your practice, look for people who have been trained in CBT or IPT. It is particularly helpful to know whether therapists have seen patients using CBT or IPT while getting supervision in these modalities.
CBT and IPT are different. CBT puts an emphasis on the thought-feeling-behavior triangle while IPT focuses more on relationships. Someone who has tried one and has not benefited nevertheless may benefit from the other.
Working with your patients to choose what type of psychotherapy modality for depression they would like is particularly effective.
Finally, be aware of how the environment may be affecting your patient. School issues related to peers, learning style or disabilities, and organization have a major effect on teens. In this case, Paul is looking at his phone nightly, which may be affecting both his sleep and self-esteem. Family issues continue to play a key role.
Paul was referred for CBT therapy, which was moderately helpful. After a few months, sertraline was added with further improvement. A key element in fully resolving Paul’s depression was his becoming involved in the drama club, which gave him the chance to meet a group of peers who shared his interests.
Dr. Hall is assistant professor of psychiatry and pediatrics at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at [email protected].
References
1. JAMA. 2007 Apr 18;297(15):1683-96.
2. Am J Psychiatry. 2017 May 1;174(5):430-7.
3. J Child Adolesc Psychopharmacol. 2018. doi: 10.1089/cap.2017.0174.
4. J Clin Child Adolesc Psychol. 2017 Jan-Feb;46(1):11-43.
Paul is 13-year-old male in seventh grade with a history of inattentive ADHD and a positive family history of depression and anxiety in his mother. He always has had a few friends, but recently they have not wanted to hang out with him; he feels like people are ignoring him. For the past 2 months, Paul’s mood has gotten very low. He feels sad and also bored because he is not enjoying anything anymore. He feels as though he is “a loser,” and as though nothing will ever get better. His grades have dropped. He has thoughts of wishing he were dead, although he has no specific plan and says he wouldn’t do it because he doesn’t want to hurt his parents. He is looking at his phone at night and gets to bed late, then doesn’t want to get up in the morning. He sleeps until noon on weekends. Appetite is increased. He doesn’t have energy to do things on the weekends.
Discussion
Paul clearly meets diagnostic criteria for depression. He feels sad and has lost pleasure in activities he used to enjoy. He has negative, hopeless thoughts, and vague thoughts of death although no specific plans. He has vegetative signs of depression with increased appetite and sleep; he likely has worse concentration than usual, given that his grades have dropped. Energy is low.
Meta-analyses have demonstrated the efficacy of SSRIs (fluoxetine, sertraline, citalopram, escitalopram) as well as venlafaxine, mirtazapine, and nefazodone with small to very small effect sizes.1 A large placebo effect is seen in many of these studies, correlating with the number of study sites – a feature of many industry-sponsored studies.
John Walkup, MD, a leading researcher on both medication and psychotherapeutic interventions in children’s mood disorders, has pointed out that the quality of industry-sponsored studies (vs. National Institute of Mental Health–sponsored studies) is likely lower, with more pressure to get in large numbers of patients in a short period of time, less trained investigators leading to less clear-cut diagnoses, and other sources of bias.2 This raises the question of whether we should weight NIMH-sponsored studies more heavily in meta-analyses.
A second factor to consider is the risk of harm, and a significant issue here is the question of whether suicidal ideation is increased among those patients taking SSRIs. Meta-analyses from the late 2000s, which balanced the number needed to treat vs. the number needed to harm, judged that for children under age 13 years, fluoxetine was the only antidepressant that was worth the cost-benefit ratio. However, in the past several years there has been a major improvement in the assessment of suicidal ideation in the form of the Columbia Suicide Severity Rating Scale, a standardized method of assessing the presence and significance of suicidal thoughts and behaviors. Studies that have used this assessment have found no significant increase in suicidal ideation with SSRIs vs. placebo.
The takeaway here is that the SSRIs can work, with fluoxetine, sertraline, and escitalopram leading the evidence, and that with refinements of the assessment they do not appear to increase the risk of suicidal ideation.3 Of course, it remains important to discuss this issue with families.
Psychotherapy is the other major treatment for depression. Cognitive behavioral therapy (CBT) and Interpersonal therapy (IPT) for adolescents show effectiveness in teens.4 Recent meta-analyses have gotten stronger through the use of stringent quality criteria and the inclusion of negative studies; these therapies continue to be considered well established. It is worthwhile to talk to therapists in your community to understand what type of treatment they offer. If you are hiring therapists to be embedded in your practice, look for people who have been trained in CBT or IPT. It is particularly helpful to know whether therapists have seen patients using CBT or IPT while getting supervision in these modalities.
CBT and IPT are different. CBT puts an emphasis on the thought-feeling-behavior triangle while IPT focuses more on relationships. Someone who has tried one and has not benefited nevertheless may benefit from the other.
Working with your patients to choose what type of psychotherapy modality for depression they would like is particularly effective.
Finally, be aware of how the environment may be affecting your patient. School issues related to peers, learning style or disabilities, and organization have a major effect on teens. In this case, Paul is looking at his phone nightly, which may be affecting both his sleep and self-esteem. Family issues continue to play a key role.
Paul was referred for CBT therapy, which was moderately helpful. After a few months, sertraline was added with further improvement. A key element in fully resolving Paul’s depression was his becoming involved in the drama club, which gave him the chance to meet a group of peers who shared his interests.
Dr. Hall is assistant professor of psychiatry and pediatrics at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at [email protected].
References
1. JAMA. 2007 Apr 18;297(15):1683-96.
2. Am J Psychiatry. 2017 May 1;174(5):430-7.
3. J Child Adolesc Psychopharmacol. 2018. doi: 10.1089/cap.2017.0174.
4. J Clin Child Adolesc Psychol. 2017 Jan-Feb;46(1):11-43.
Novel immunostimulant combo shows early efficacy
SAN FRANCISCO – A combination of two novel immune-stimulating agents has shown early evidence of efficacy against malignant melanoma, leiomyosarcoma, and triple-negative breast cancer in a phase 1b, dose-escalating study.
Among 11 evaluable patients enrolled in a trial of NKTR-262, a small molecule agonist of toll-like receptors (TLR) 7/8, and bempegaldesleukin, an interleukin-2 pathway agonist, 2 had a partial response and 3 had stable disease, reported Adi Diab, MD, from the University of Texas MD Anderson Cancer Center, Houston, and his colleagues.
Patients tolerated the combination well, and there have been no serious adverse events or dose-limiting toxicities.
“Pharmacodynamic data demonstrate both activation of the systemic adaptive and the local innate immune system, and we have seen early evidence of clinical activity in patients who are refractory to checkpoint inhibitors with immunotherapy regimens,” Dr. Diab said at the American Society of Clinical Oncology (ASCO) – Society for Immunotherapy of Cancer (SITC): Clinical Immuno-Oncology Symposium.
NKTR-262 is injected into tumors and is designed to be retained in the tumor microenvironment where it helps to activate antigen-presenting cells, such as dendritic cells, and primes development of new, antigen-specific cytotoxic T cells. Bempegaldesleukin is a cytokine that works within the IL-2 pathway to increase CD8-positive T cells and natural killer (NK) cells in the tumor microenvironment.
The rationale for the combination is that NKTR-262 can activate innate immunity in cells surrounding the tumor microenvironment and activate the machinery of antigen-presenting cells, and bempegaldesleukin can prime and boost a systemic tumor immune response that can ultimately mediate antitumor activity in distant lesions, Dr. Adib said.
In preclinical models, the combination of these agents led to a robust antitumor effect that also involved distant lesions through mediation of the abscopal effect, in which treatment of a tumor activates an immune response against distant tumor cells as well, Dr. Diab said.
The REVEAL study is an ongoing, phase 1b/2 trial looking at the combination in melanoma, Merkel cell carcinoma, triple-negative breast cancer (TNBC), ovarian cancer, renal cell carcinoma, colorectal cancer, urothelial carcinoma, and sarcoma.
The primary goal of the study is to evaluate safety and determine the optimal phase 2 dose of the combination, evaluate biomarkers of response, and assess antitumor activity. As of Jan. 23, 2019, 13 patients were enrolled and evaluable for safety, and 11 were evaluable for the preliminary efficacy analysis.
The most common treatment-related adverse events (TRAEs) with the combination were transient grade 1 or 2 flu-like symptoms, rash, fatigue, pruritus, and nausea. One patients developed grade 3 maculopapular rash and leukocytosis.
Most of the TRAEs are attributable to bempegaldesleukin. There were no immune-mediated AEs and no TRAEs resulted in study discontinuation.
Tumor biopsies obtained 24 hours after injection of NKTR-262 confirmed the activation of TLR 7/8 and robust induction of type 1 interferon, interferon-alpha, and interferon-beta gene-related signatures necessary for optimal antigen presentation.
Dr. Diab noted that in a different trial of bempegaldesleukin monotherapy there was no significant increase in the type 1 interferon gene signature, but the agent did promote activation of the adaptive immune system.
The complementary nature of the two novel agents could also be demonstrated in evaluation of peripheral blood samples, which showed that, although there was no proliferation of T or NK cells following NKTR-262 injection, the addition of bempegaldesleukin resulted in the proliferation of both effector T cells and NK cells to enhance the systemic immune response.
The preliminary efficacy analysis showed that two of five patients with stage IV melanoma who experienced disease progression on prior immune checkpoint inhibitors had partial responses, including one who had a 100% reduction in target lesions and the other with a 50% reduction. In addition, two patients with heavily pretreated leiomyosarcoma had stable disease as the best response, as did the single patient with TNBC.
The maximum tolerated dose of the combination has not been identified, and the investigators are continuing to enroll patients.
The REVEAL study is supported by Nektar Therapeutics. Dr. Diab reported institutional research funding, consulting fees, and advisory board participation from Nektar, Bristol-Myers Squib, Idera Pharmaceuticals, Jounce Therapeutics, and Array BioPharma.
SOURCE: Diab A et al. ASCO-SITC, Abstract 26.
SAN FRANCISCO – A combination of two novel immune-stimulating agents has shown early evidence of efficacy against malignant melanoma, leiomyosarcoma, and triple-negative breast cancer in a phase 1b, dose-escalating study.
Among 11 evaluable patients enrolled in a trial of NKTR-262, a small molecule agonist of toll-like receptors (TLR) 7/8, and bempegaldesleukin, an interleukin-2 pathway agonist, 2 had a partial response and 3 had stable disease, reported Adi Diab, MD, from the University of Texas MD Anderson Cancer Center, Houston, and his colleagues.
Patients tolerated the combination well, and there have been no serious adverse events or dose-limiting toxicities.
“Pharmacodynamic data demonstrate both activation of the systemic adaptive and the local innate immune system, and we have seen early evidence of clinical activity in patients who are refractory to checkpoint inhibitors with immunotherapy regimens,” Dr. Diab said at the American Society of Clinical Oncology (ASCO) – Society for Immunotherapy of Cancer (SITC): Clinical Immuno-Oncology Symposium.
NKTR-262 is injected into tumors and is designed to be retained in the tumor microenvironment where it helps to activate antigen-presenting cells, such as dendritic cells, and primes development of new, antigen-specific cytotoxic T cells. Bempegaldesleukin is a cytokine that works within the IL-2 pathway to increase CD8-positive T cells and natural killer (NK) cells in the tumor microenvironment.
The rationale for the combination is that NKTR-262 can activate innate immunity in cells surrounding the tumor microenvironment and activate the machinery of antigen-presenting cells, and bempegaldesleukin can prime and boost a systemic tumor immune response that can ultimately mediate antitumor activity in distant lesions, Dr. Adib said.
In preclinical models, the combination of these agents led to a robust antitumor effect that also involved distant lesions through mediation of the abscopal effect, in which treatment of a tumor activates an immune response against distant tumor cells as well, Dr. Diab said.
The REVEAL study is an ongoing, phase 1b/2 trial looking at the combination in melanoma, Merkel cell carcinoma, triple-negative breast cancer (TNBC), ovarian cancer, renal cell carcinoma, colorectal cancer, urothelial carcinoma, and sarcoma.
The primary goal of the study is to evaluate safety and determine the optimal phase 2 dose of the combination, evaluate biomarkers of response, and assess antitumor activity. As of Jan. 23, 2019, 13 patients were enrolled and evaluable for safety, and 11 were evaluable for the preliminary efficacy analysis.
The most common treatment-related adverse events (TRAEs) with the combination were transient grade 1 or 2 flu-like symptoms, rash, fatigue, pruritus, and nausea. One patients developed grade 3 maculopapular rash and leukocytosis.
Most of the TRAEs are attributable to bempegaldesleukin. There were no immune-mediated AEs and no TRAEs resulted in study discontinuation.
Tumor biopsies obtained 24 hours after injection of NKTR-262 confirmed the activation of TLR 7/8 and robust induction of type 1 interferon, interferon-alpha, and interferon-beta gene-related signatures necessary for optimal antigen presentation.
Dr. Diab noted that in a different trial of bempegaldesleukin monotherapy there was no significant increase in the type 1 interferon gene signature, but the agent did promote activation of the adaptive immune system.
The complementary nature of the two novel agents could also be demonstrated in evaluation of peripheral blood samples, which showed that, although there was no proliferation of T or NK cells following NKTR-262 injection, the addition of bempegaldesleukin resulted in the proliferation of both effector T cells and NK cells to enhance the systemic immune response.
The preliminary efficacy analysis showed that two of five patients with stage IV melanoma who experienced disease progression on prior immune checkpoint inhibitors had partial responses, including one who had a 100% reduction in target lesions and the other with a 50% reduction. In addition, two patients with heavily pretreated leiomyosarcoma had stable disease as the best response, as did the single patient with TNBC.
The maximum tolerated dose of the combination has not been identified, and the investigators are continuing to enroll patients.
The REVEAL study is supported by Nektar Therapeutics. Dr. Diab reported institutional research funding, consulting fees, and advisory board participation from Nektar, Bristol-Myers Squib, Idera Pharmaceuticals, Jounce Therapeutics, and Array BioPharma.
SOURCE: Diab A et al. ASCO-SITC, Abstract 26.
SAN FRANCISCO – A combination of two novel immune-stimulating agents has shown early evidence of efficacy against malignant melanoma, leiomyosarcoma, and triple-negative breast cancer in a phase 1b, dose-escalating study.
Among 11 evaluable patients enrolled in a trial of NKTR-262, a small molecule agonist of toll-like receptors (TLR) 7/8, and bempegaldesleukin, an interleukin-2 pathway agonist, 2 had a partial response and 3 had stable disease, reported Adi Diab, MD, from the University of Texas MD Anderson Cancer Center, Houston, and his colleagues.
Patients tolerated the combination well, and there have been no serious adverse events or dose-limiting toxicities.
“Pharmacodynamic data demonstrate both activation of the systemic adaptive and the local innate immune system, and we have seen early evidence of clinical activity in patients who are refractory to checkpoint inhibitors with immunotherapy regimens,” Dr. Diab said at the American Society of Clinical Oncology (ASCO) – Society for Immunotherapy of Cancer (SITC): Clinical Immuno-Oncology Symposium.
NKTR-262 is injected into tumors and is designed to be retained in the tumor microenvironment where it helps to activate antigen-presenting cells, such as dendritic cells, and primes development of new, antigen-specific cytotoxic T cells. Bempegaldesleukin is a cytokine that works within the IL-2 pathway to increase CD8-positive T cells and natural killer (NK) cells in the tumor microenvironment.
The rationale for the combination is that NKTR-262 can activate innate immunity in cells surrounding the tumor microenvironment and activate the machinery of antigen-presenting cells, and bempegaldesleukin can prime and boost a systemic tumor immune response that can ultimately mediate antitumor activity in distant lesions, Dr. Adib said.
In preclinical models, the combination of these agents led to a robust antitumor effect that also involved distant lesions through mediation of the abscopal effect, in which treatment of a tumor activates an immune response against distant tumor cells as well, Dr. Diab said.
The REVEAL study is an ongoing, phase 1b/2 trial looking at the combination in melanoma, Merkel cell carcinoma, triple-negative breast cancer (TNBC), ovarian cancer, renal cell carcinoma, colorectal cancer, urothelial carcinoma, and sarcoma.
The primary goal of the study is to evaluate safety and determine the optimal phase 2 dose of the combination, evaluate biomarkers of response, and assess antitumor activity. As of Jan. 23, 2019, 13 patients were enrolled and evaluable for safety, and 11 were evaluable for the preliminary efficacy analysis.
The most common treatment-related adverse events (TRAEs) with the combination were transient grade 1 or 2 flu-like symptoms, rash, fatigue, pruritus, and nausea. One patients developed grade 3 maculopapular rash and leukocytosis.
Most of the TRAEs are attributable to bempegaldesleukin. There were no immune-mediated AEs and no TRAEs resulted in study discontinuation.
Tumor biopsies obtained 24 hours after injection of NKTR-262 confirmed the activation of TLR 7/8 and robust induction of type 1 interferon, interferon-alpha, and interferon-beta gene-related signatures necessary for optimal antigen presentation.
Dr. Diab noted that in a different trial of bempegaldesleukin monotherapy there was no significant increase in the type 1 interferon gene signature, but the agent did promote activation of the adaptive immune system.
The complementary nature of the two novel agents could also be demonstrated in evaluation of peripheral blood samples, which showed that, although there was no proliferation of T or NK cells following NKTR-262 injection, the addition of bempegaldesleukin resulted in the proliferation of both effector T cells and NK cells to enhance the systemic immune response.
The preliminary efficacy analysis showed that two of five patients with stage IV melanoma who experienced disease progression on prior immune checkpoint inhibitors had partial responses, including one who had a 100% reduction in target lesions and the other with a 50% reduction. In addition, two patients with heavily pretreated leiomyosarcoma had stable disease as the best response, as did the single patient with TNBC.
The maximum tolerated dose of the combination has not been identified, and the investigators are continuing to enroll patients.
The REVEAL study is supported by Nektar Therapeutics. Dr. Diab reported institutional research funding, consulting fees, and advisory board participation from Nektar, Bristol-Myers Squib, Idera Pharmaceuticals, Jounce Therapeutics, and Array BioPharma.
SOURCE: Diab A et al. ASCO-SITC, Abstract 26.
REPORTING FROM ASCO-SITC
Getting that Dx right, keeping patients safe
Even the best physicians make mistakes.
Each of us can recall a patient for whom our initial diagnosis was incorrect, or conversely, where we uncovered the correct diagnosis. My memorable mistake was missing an obvious case of hypothyroidism, and my happier encounter was correcting an incorrect diagnosis of asthma when the patient actually had primary pulmonary fibrosis. These patients came to mind as I read this month’s cover story, “COPD and asthma: Diagnostic accuracy requires spirometry.”
In a previous editorial, “When our biases derail the diagnosis,”1 I discussed types of cognitive bias that can lead us to the wrong conclusion. Today, I want to address diagnostic errors in medicine as a patient safety issue.
The patient safety movement gained traction in 1999 with the publication of the Institute of Medicine (IOM, now National Academy of Medicine) report, To Err is Human: Building a Safer Health System. That report focused on health care system issues and had little to offer regarding improving diagnoses. It was not until 2015, with the publication of the IOM report Improving Diagnosis in Health Care, that serious national attention was directed to accurate diagnosis. It is worth reading the summary of this report, which includes 8 goals and is available at nas.edu/improvingdiagnosis.
The recommendations most pertinent to family physicians are to: 1) facilitate more effective teamwork among health care professionals, patients, and families, 2) teach health care professionals about the diagnostic process, 3) ensure that technology supports proper diagnosis, 4) establish a work culture that supports diagnostic processes, and 5) identify diagnostic errors and learn from them.
Teamwork. The first recommendation is intriguing because the focus on teamwork includes patients and their families. I have found that listening closely to the patient’s and family’s concerns can lead me in a direction other than my initial impression—especially when they are insistent about a particular diagnosis.
Technology. Despite all of their “warts,” electronic health records are gradually incorporating clinical decision support tools that really do help steer us in the right direction. I have found that electronic point-of-care references can be very helpful in establishing an accurate diagnosis in the exam room—and can help convince patients that my diagnosis is correct when they read it for themselves!
Continue to: Finally, discussing our mistakes...
Finally, discussing our mistakes openly with our colleagues helps us—and them—to avoid that mistake in the future. Let’s be sure to keep that dialogue open. And let’s continue to refine our diagnostic skills so that we can continue to keep our patients safe.
1. Hickner J. When our biases derail the diagnosis. J Fam Pract. 2018;67:334.
Editor-in-Chief
Editor-in-Chief
Editor-in-Chief
Even the best physicians make mistakes.
Each of us can recall a patient for whom our initial diagnosis was incorrect, or conversely, where we uncovered the correct diagnosis. My memorable mistake was missing an obvious case of hypothyroidism, and my happier encounter was correcting an incorrect diagnosis of asthma when the patient actually had primary pulmonary fibrosis. These patients came to mind as I read this month’s cover story, “COPD and asthma: Diagnostic accuracy requires spirometry.”
In a previous editorial, “When our biases derail the diagnosis,”1 I discussed types of cognitive bias that can lead us to the wrong conclusion. Today, I want to address diagnostic errors in medicine as a patient safety issue.
The patient safety movement gained traction in 1999 with the publication of the Institute of Medicine (IOM, now National Academy of Medicine) report, To Err is Human: Building a Safer Health System. That report focused on health care system issues and had little to offer regarding improving diagnoses. It was not until 2015, with the publication of the IOM report Improving Diagnosis in Health Care, that serious national attention was directed to accurate diagnosis. It is worth reading the summary of this report, which includes 8 goals and is available at nas.edu/improvingdiagnosis.
The recommendations most pertinent to family physicians are to: 1) facilitate more effective teamwork among health care professionals, patients, and families, 2) teach health care professionals about the diagnostic process, 3) ensure that technology supports proper diagnosis, 4) establish a work culture that supports diagnostic processes, and 5) identify diagnostic errors and learn from them.
Teamwork. The first recommendation is intriguing because the focus on teamwork includes patients and their families. I have found that listening closely to the patient’s and family’s concerns can lead me in a direction other than my initial impression—especially when they are insistent about a particular diagnosis.
Technology. Despite all of their “warts,” electronic health records are gradually incorporating clinical decision support tools that really do help steer us in the right direction. I have found that electronic point-of-care references can be very helpful in establishing an accurate diagnosis in the exam room—and can help convince patients that my diagnosis is correct when they read it for themselves!
Continue to: Finally, discussing our mistakes...
Finally, discussing our mistakes openly with our colleagues helps us—and them—to avoid that mistake in the future. Let’s be sure to keep that dialogue open. And let’s continue to refine our diagnostic skills so that we can continue to keep our patients safe.
Even the best physicians make mistakes.
Each of us can recall a patient for whom our initial diagnosis was incorrect, or conversely, where we uncovered the correct diagnosis. My memorable mistake was missing an obvious case of hypothyroidism, and my happier encounter was correcting an incorrect diagnosis of asthma when the patient actually had primary pulmonary fibrosis. These patients came to mind as I read this month’s cover story, “COPD and asthma: Diagnostic accuracy requires spirometry.”
In a previous editorial, “When our biases derail the diagnosis,”1 I discussed types of cognitive bias that can lead us to the wrong conclusion. Today, I want to address diagnostic errors in medicine as a patient safety issue.
The patient safety movement gained traction in 1999 with the publication of the Institute of Medicine (IOM, now National Academy of Medicine) report, To Err is Human: Building a Safer Health System. That report focused on health care system issues and had little to offer regarding improving diagnoses. It was not until 2015, with the publication of the IOM report Improving Diagnosis in Health Care, that serious national attention was directed to accurate diagnosis. It is worth reading the summary of this report, which includes 8 goals and is available at nas.edu/improvingdiagnosis.
The recommendations most pertinent to family physicians are to: 1) facilitate more effective teamwork among health care professionals, patients, and families, 2) teach health care professionals about the diagnostic process, 3) ensure that technology supports proper diagnosis, 4) establish a work culture that supports diagnostic processes, and 5) identify diagnostic errors and learn from them.
Teamwork. The first recommendation is intriguing because the focus on teamwork includes patients and their families. I have found that listening closely to the patient’s and family’s concerns can lead me in a direction other than my initial impression—especially when they are insistent about a particular diagnosis.
Technology. Despite all of their “warts,” electronic health records are gradually incorporating clinical decision support tools that really do help steer us in the right direction. I have found that electronic point-of-care references can be very helpful in establishing an accurate diagnosis in the exam room—and can help convince patients that my diagnosis is correct when they read it for themselves!
Continue to: Finally, discussing our mistakes...
Finally, discussing our mistakes openly with our colleagues helps us—and them—to avoid that mistake in the future. Let’s be sure to keep that dialogue open. And let’s continue to refine our diagnostic skills so that we can continue to keep our patients safe.
1. Hickner J. When our biases derail the diagnosis. J Fam Pract. 2018;67:334.
1. Hickner J. When our biases derail the diagnosis. J Fam Pract. 2018;67:334.
MRI is a critical part of the MS precision medicine toolkit
DALLAS – MRI has long been important in both diagnosis and management of multiple sclerosis (MS). It’s more important than ever though, as perivenular demyelinating lesions emerge as a potential biomarker of the disease, and a key tool in precision medicine initiatives that target MS.
“The central vein sign is at the current time still a research tool that is being touted as an imaging finding that may be a very useful biomarker for diagnosis in MS,” said Jiwon Oh, MD, PhD, in an interview at the meeting presented by the Americas Committee for Treatment and Research in Multiple Sclerosis.
It’s almost ready for “prime time,” she said, “because it can easily be acquired on most conventional 3 Tesla MRI scanners, the sequences that you use don’t require an inordinate amount of time [and] it doesn’t take too much training to be able to easily identify the sign.”
A number of groups have evaluated the central vein sign and are finding it “a very specific biomarker” for MS, Dr. Oh said.
“It would be very useful in very early stages of diagnosis because it would prevent people from being misdiagnosed” and being treated unnecessarily, she said.
In her own work, Dr. Oh and her collaborators are following a cohort of people with radiologically isolated syndrome (RIS) discovered incidentally on brain imaging. “It’s a very valuable patient population to study because it may give us insight into the very earliest stages of MS,” as the lesions were not accompanied by any symptoms when they were first noticed.
Dr. Oh and her colleagues are finding that, among RIS patients, “the vast, vast majority of people have lesions with central veins; in our cohort, over 90% of patients met the 40% threshold that has been proposed to distinguish MS from other white matter changes.”
Dr. Oh said that the central vein sign may prove to be prognostic among RIS patients; they continue to follow the cohort being studied at the University of Toronto, where Dr. Oh is a neurologist.
DALLAS – MRI has long been important in both diagnosis and management of multiple sclerosis (MS). It’s more important than ever though, as perivenular demyelinating lesions emerge as a potential biomarker of the disease, and a key tool in precision medicine initiatives that target MS.
“The central vein sign is at the current time still a research tool that is being touted as an imaging finding that may be a very useful biomarker for diagnosis in MS,” said Jiwon Oh, MD, PhD, in an interview at the meeting presented by the Americas Committee for Treatment and Research in Multiple Sclerosis.
It’s almost ready for “prime time,” she said, “because it can easily be acquired on most conventional 3 Tesla MRI scanners, the sequences that you use don’t require an inordinate amount of time [and] it doesn’t take too much training to be able to easily identify the sign.”
A number of groups have evaluated the central vein sign and are finding it “a very specific biomarker” for MS, Dr. Oh said.
“It would be very useful in very early stages of diagnosis because it would prevent people from being misdiagnosed” and being treated unnecessarily, she said.
In her own work, Dr. Oh and her collaborators are following a cohort of people with radiologically isolated syndrome (RIS) discovered incidentally on brain imaging. “It’s a very valuable patient population to study because it may give us insight into the very earliest stages of MS,” as the lesions were not accompanied by any symptoms when they were first noticed.
Dr. Oh and her colleagues are finding that, among RIS patients, “the vast, vast majority of people have lesions with central veins; in our cohort, over 90% of patients met the 40% threshold that has been proposed to distinguish MS from other white matter changes.”
Dr. Oh said that the central vein sign may prove to be prognostic among RIS patients; they continue to follow the cohort being studied at the University of Toronto, where Dr. Oh is a neurologist.
DALLAS – MRI has long been important in both diagnosis and management of multiple sclerosis (MS). It’s more important than ever though, as perivenular demyelinating lesions emerge as a potential biomarker of the disease, and a key tool in precision medicine initiatives that target MS.
“The central vein sign is at the current time still a research tool that is being touted as an imaging finding that may be a very useful biomarker for diagnosis in MS,” said Jiwon Oh, MD, PhD, in an interview at the meeting presented by the Americas Committee for Treatment and Research in Multiple Sclerosis.
It’s almost ready for “prime time,” she said, “because it can easily be acquired on most conventional 3 Tesla MRI scanners, the sequences that you use don’t require an inordinate amount of time [and] it doesn’t take too much training to be able to easily identify the sign.”
A number of groups have evaluated the central vein sign and are finding it “a very specific biomarker” for MS, Dr. Oh said.
“It would be very useful in very early stages of diagnosis because it would prevent people from being misdiagnosed” and being treated unnecessarily, she said.
In her own work, Dr. Oh and her collaborators are following a cohort of people with radiologically isolated syndrome (RIS) discovered incidentally on brain imaging. “It’s a very valuable patient population to study because it may give us insight into the very earliest stages of MS,” as the lesions were not accompanied by any symptoms when they were first noticed.
Dr. Oh and her colleagues are finding that, among RIS patients, “the vast, vast majority of people have lesions with central veins; in our cohort, over 90% of patients met the 40% threshold that has been proposed to distinguish MS from other white matter changes.”
Dr. Oh said that the central vein sign may prove to be prognostic among RIS patients; they continue to follow the cohort being studied at the University of Toronto, where Dr. Oh is a neurologist.
REPORTING FROM ACTRIMS FORUM 2019
Interventional cardiology pioneer reflects on field’s past, future
SNOWMASS, COLO. – When Spencer B. King III, MD, shared his thoughts about the future of interventional cardiology at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology, he felt compelled to offer a cautionary note about his past accuracy as a prognosticator.
It was way back at a poster session during the 1976 annual meeting of the American Heart Association in Miami Beach that he first met Andreas Gruentzig, MD, the father of percutaneous coronary intervention (PCI), who was presenting his initial revolutionary work on what he called “coronary transluminal angioplasty” in dogs.
“I looked at the poster and told him it would never work,” recalled Dr. King, professor emeritus of medicine at Emory University in Atlanta.
He soon changed his mind, however, because, to great acclaim, Dr. Gruentzig performed his successful first in-human coronary angioplasty the next year.
He noted that the Snowmass conference has played a significant role in the development of interventional cardiology in the United States. Dr. Gruentzig attended the conference in 1980, and Dr. King and others took that opportunity to persuade him to leave the bureaucratic confines of Zurich and join him at Emory later that year. The two cardiologists worked closely thereafter, refining angioplasty and conducting clinical trials until Dr. Gruentzig’s death in an airplane crash in Georgia in 1985 at age 46 years.
Turning to the future, Dr. King addressed a number of recent developments in interventional cardiology and rated their chances of significantly improving outcomes in patients with stable ischemic heart disease. He graded the innovations’ potential with use of a four-bar schema, akin to the WiFi signal power rating on a cell phone.
Noninvasive diagnostics to assess anatomy and physiology
“I think coronary CT angiography [CTA] will become the new diagnostic angiogram,” he predicted. “CTA has gotten much better. Outside the United States, in Europe and particularly in Japan and increasingly in China, CTA is becoming extremely common.”
Dr. King cited a recent multicenter study of blinded heart team treatment decision making on the basis of either CTA or conventional invasive angiography in 223 patients with left main or triple-vessel coronary artery disease (CAD). The level of agreement was impressively high: Coronary artery bypass grafting (CABG) was recommended for 28% of patients on the basis of CTA and 26% with conventional angiography, which suggests the feasibility of treatment decision making based solely on noninvasive imaging, history, and clinical examination (Eur Heart J. 2018 Nov 1;39[41]:3689-98).
“The other thing I like about the potential for noninvasive imaging to guide our interventions is that it may [replace] the diagnostic angiogram, which has largely become extinct,” the cardiologist continued. “If you think about it, patients are referred for an angiogram, and as far as informed consent is concerned, the patient is told to pack his bags, go off to some other city, get in the cath lab, and take the family because of what they might do to you. They might put stents in you, they might operate on you. We don’t have any idea because we don’t know what you have. And the patient has to buy into this. With CTA, the potential is there for people to actually know what you’re going to do to them before you do it.”
Coronary artery calcium scoring for primary risk assessment has taken on a prominent role in the latest practice guidelines. “I think it’s mostly helpful in getting people out of the system because they don’t have any calcium,” in Dr. King’s view.
PET and MRI will remain secondary noninvasive technologies. They will be used mostly to diagnose microvascular disease, but that’s information that doesn’t have much influence on whether interventional procedures are performed.
Overall, he gave noninvasive diagnostic tools high marks for their potential to improve outcomes in patients with stable ischemic heart disease.
“I give it a pretty robust three bars. Maybe you could give it four,” he said.
New pharmacologic therapies
Citing in particular the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors and the sodium-glucose cotransporter 2 (SGLT2) inhibitors, Dr. King declared, “It may be that the biggest, newest device in interventional cardiology going forward is not a device at all, it’s medical therapy.”
Interventional cardiologists either need to become expert in advanced medical therapies or else have access to someone in their group who prescribes those medications deftly.
“The future care of our patients will require more than percutaneous coronary intervention,” he emphasized.
So, four bars for the new medical therapies.
PCI and coronary artery bypass surgery
Both get one bar.
“PCI will be a partner of advanced antiatherosclerotic therapies, but will not be replaced by limiting antianginal therapy to medical treatment only,” Dr. King predicted.
Regarding CABG, he highlighted a recent systematic review and pooled analysis of 11,518 patients with stable ischemic heart disease randomized to CABG or PCI using drug-eluting or bare-metal stents in 11 clinical trials. CABG demonstrated a significant mortality benefit over PCI in patients with multivessel disease, particularly among those with diabetes or a higher degree of coronary disease complexity. However, there was no benefit in terms of 5-year all-cause mortality for CABG over PCI in those with left main disease (Lancet. 2018 Mar 10;391[10124]:9399-48).
“CABG will not go away. I predict that about 25% of revascularizations will continue to be done by surgery,” the cardiologist said. “For patients who can have complete revascularization by PCI, it’ll be done with advanced technology, but probably only by a subset of operators. We have a huge number of interventional cardiologists in this country, and some of them do a lot of these kinds of cases and some don’t.”
Endovascular imaging to optimize stent deployment and characterize plaque
Studies suggest that the use of intravascular ultrasound and other endovascular imaging technologies ends up providing better results than when they’re not employed.
“We see greatly increased use of IVUS [intravascular ultrasound], and not so much of optical coherence tomography, because of technical problems. So I give this at least two bars as far as moving practice forward,” according to Dr. King.
Bioresorbable scaffolds
This technology, which he noted “was supposed to solve all of our problems,” has tripped and fallen because of its associated increased risk of scaffold thrombosis. He cited a recent network meta-analysis of 91 randomized, controlled trials comparing bioresorbable scaffolds to current-generation metallic drug-eluting stents in more than 105,000 patients. The bioresorbable scaffolds had a significantly higher rate of scaffold thrombosis in the first 30 days after implantation, as well as from 31 days through 1 year and also beyond 1 year. In fact, there was a rising trend for scaffold thrombosis in the bioresorbable device group after the 1 year mark through a mean 3.7 years of follow-up (EuroIntervention. 2018 Mar 20;13[16]:1904-13).
“The overall impact of bioresorbable scaffolds has been nil. We don’t have them. Bioresorbable scaffolds may become noninferior to the best metal stents, but to become mainstream, they should show superiority,” the cardiologist said.
One bar, based on the uncertain possibility that new bioresorbable scaffolds now in early stages of development ultimately pan out.
Future training needs
PCI operator volumes are low, and that raises a host of issues regarding future training needs. Should fewer interventionalists be trained? Should training in endovascular imaging be a mandatory part of PCI training? Should interventional cardiology be divided into distinct coronary, structural heart, and peripheral vascular subspecialty domains involving different people, a change that is already informally underway in many places? How are operators who are interested in becoming experts in PCI for chronic total occlusion, diffuse disease, left main disease, or other complex cases going to get enough experience to be able to concentrate in those areas?
These are questions that will need to be addressed in the coming years. The answers will surely affect the delivery of interventional cardiology care.
Dr. King reported having no financial conflicts regarding his presentation.
SOURCE: King SB.
SNOWMASS, COLO. – When Spencer B. King III, MD, shared his thoughts about the future of interventional cardiology at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology, he felt compelled to offer a cautionary note about his past accuracy as a prognosticator.
It was way back at a poster session during the 1976 annual meeting of the American Heart Association in Miami Beach that he first met Andreas Gruentzig, MD, the father of percutaneous coronary intervention (PCI), who was presenting his initial revolutionary work on what he called “coronary transluminal angioplasty” in dogs.
“I looked at the poster and told him it would never work,” recalled Dr. King, professor emeritus of medicine at Emory University in Atlanta.
He soon changed his mind, however, because, to great acclaim, Dr. Gruentzig performed his successful first in-human coronary angioplasty the next year.
He noted that the Snowmass conference has played a significant role in the development of interventional cardiology in the United States. Dr. Gruentzig attended the conference in 1980, and Dr. King and others took that opportunity to persuade him to leave the bureaucratic confines of Zurich and join him at Emory later that year. The two cardiologists worked closely thereafter, refining angioplasty and conducting clinical trials until Dr. Gruentzig’s death in an airplane crash in Georgia in 1985 at age 46 years.
Turning to the future, Dr. King addressed a number of recent developments in interventional cardiology and rated their chances of significantly improving outcomes in patients with stable ischemic heart disease. He graded the innovations’ potential with use of a four-bar schema, akin to the WiFi signal power rating on a cell phone.
Noninvasive diagnostics to assess anatomy and physiology
“I think coronary CT angiography [CTA] will become the new diagnostic angiogram,” he predicted. “CTA has gotten much better. Outside the United States, in Europe and particularly in Japan and increasingly in China, CTA is becoming extremely common.”
Dr. King cited a recent multicenter study of blinded heart team treatment decision making on the basis of either CTA or conventional invasive angiography in 223 patients with left main or triple-vessel coronary artery disease (CAD). The level of agreement was impressively high: Coronary artery bypass grafting (CABG) was recommended for 28% of patients on the basis of CTA and 26% with conventional angiography, which suggests the feasibility of treatment decision making based solely on noninvasive imaging, history, and clinical examination (Eur Heart J. 2018 Nov 1;39[41]:3689-98).
“The other thing I like about the potential for noninvasive imaging to guide our interventions is that it may [replace] the diagnostic angiogram, which has largely become extinct,” the cardiologist continued. “If you think about it, patients are referred for an angiogram, and as far as informed consent is concerned, the patient is told to pack his bags, go off to some other city, get in the cath lab, and take the family because of what they might do to you. They might put stents in you, they might operate on you. We don’t have any idea because we don’t know what you have. And the patient has to buy into this. With CTA, the potential is there for people to actually know what you’re going to do to them before you do it.”
Coronary artery calcium scoring for primary risk assessment has taken on a prominent role in the latest practice guidelines. “I think it’s mostly helpful in getting people out of the system because they don’t have any calcium,” in Dr. King’s view.
PET and MRI will remain secondary noninvasive technologies. They will be used mostly to diagnose microvascular disease, but that’s information that doesn’t have much influence on whether interventional procedures are performed.
Overall, he gave noninvasive diagnostic tools high marks for their potential to improve outcomes in patients with stable ischemic heart disease.
“I give it a pretty robust three bars. Maybe you could give it four,” he said.
New pharmacologic therapies
Citing in particular the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors and the sodium-glucose cotransporter 2 (SGLT2) inhibitors, Dr. King declared, “It may be that the biggest, newest device in interventional cardiology going forward is not a device at all, it’s medical therapy.”
Interventional cardiologists either need to become expert in advanced medical therapies or else have access to someone in their group who prescribes those medications deftly.
“The future care of our patients will require more than percutaneous coronary intervention,” he emphasized.
So, four bars for the new medical therapies.
PCI and coronary artery bypass surgery
Both get one bar.
“PCI will be a partner of advanced antiatherosclerotic therapies, but will not be replaced by limiting antianginal therapy to medical treatment only,” Dr. King predicted.
Regarding CABG, he highlighted a recent systematic review and pooled analysis of 11,518 patients with stable ischemic heart disease randomized to CABG or PCI using drug-eluting or bare-metal stents in 11 clinical trials. CABG demonstrated a significant mortality benefit over PCI in patients with multivessel disease, particularly among those with diabetes or a higher degree of coronary disease complexity. However, there was no benefit in terms of 5-year all-cause mortality for CABG over PCI in those with left main disease (Lancet. 2018 Mar 10;391[10124]:9399-48).
“CABG will not go away. I predict that about 25% of revascularizations will continue to be done by surgery,” the cardiologist said. “For patients who can have complete revascularization by PCI, it’ll be done with advanced technology, but probably only by a subset of operators. We have a huge number of interventional cardiologists in this country, and some of them do a lot of these kinds of cases and some don’t.”
Endovascular imaging to optimize stent deployment and characterize plaque
Studies suggest that the use of intravascular ultrasound and other endovascular imaging technologies ends up providing better results than when they’re not employed.
“We see greatly increased use of IVUS [intravascular ultrasound], and not so much of optical coherence tomography, because of technical problems. So I give this at least two bars as far as moving practice forward,” according to Dr. King.
Bioresorbable scaffolds
This technology, which he noted “was supposed to solve all of our problems,” has tripped and fallen because of its associated increased risk of scaffold thrombosis. He cited a recent network meta-analysis of 91 randomized, controlled trials comparing bioresorbable scaffolds to current-generation metallic drug-eluting stents in more than 105,000 patients. The bioresorbable scaffolds had a significantly higher rate of scaffold thrombosis in the first 30 days after implantation, as well as from 31 days through 1 year and also beyond 1 year. In fact, there was a rising trend for scaffold thrombosis in the bioresorbable device group after the 1 year mark through a mean 3.7 years of follow-up (EuroIntervention. 2018 Mar 20;13[16]:1904-13).
“The overall impact of bioresorbable scaffolds has been nil. We don’t have them. Bioresorbable scaffolds may become noninferior to the best metal stents, but to become mainstream, they should show superiority,” the cardiologist said.
One bar, based on the uncertain possibility that new bioresorbable scaffolds now in early stages of development ultimately pan out.
Future training needs
PCI operator volumes are low, and that raises a host of issues regarding future training needs. Should fewer interventionalists be trained? Should training in endovascular imaging be a mandatory part of PCI training? Should interventional cardiology be divided into distinct coronary, structural heart, and peripheral vascular subspecialty domains involving different people, a change that is already informally underway in many places? How are operators who are interested in becoming experts in PCI for chronic total occlusion, diffuse disease, left main disease, or other complex cases going to get enough experience to be able to concentrate in those areas?
These are questions that will need to be addressed in the coming years. The answers will surely affect the delivery of interventional cardiology care.
Dr. King reported having no financial conflicts regarding his presentation.
SOURCE: King SB.
SNOWMASS, COLO. – When Spencer B. King III, MD, shared his thoughts about the future of interventional cardiology at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology, he felt compelled to offer a cautionary note about his past accuracy as a prognosticator.
It was way back at a poster session during the 1976 annual meeting of the American Heart Association in Miami Beach that he first met Andreas Gruentzig, MD, the father of percutaneous coronary intervention (PCI), who was presenting his initial revolutionary work on what he called “coronary transluminal angioplasty” in dogs.
“I looked at the poster and told him it would never work,” recalled Dr. King, professor emeritus of medicine at Emory University in Atlanta.
He soon changed his mind, however, because, to great acclaim, Dr. Gruentzig performed his successful first in-human coronary angioplasty the next year.
He noted that the Snowmass conference has played a significant role in the development of interventional cardiology in the United States. Dr. Gruentzig attended the conference in 1980, and Dr. King and others took that opportunity to persuade him to leave the bureaucratic confines of Zurich and join him at Emory later that year. The two cardiologists worked closely thereafter, refining angioplasty and conducting clinical trials until Dr. Gruentzig’s death in an airplane crash in Georgia in 1985 at age 46 years.
Turning to the future, Dr. King addressed a number of recent developments in interventional cardiology and rated their chances of significantly improving outcomes in patients with stable ischemic heart disease. He graded the innovations’ potential with use of a four-bar schema, akin to the WiFi signal power rating on a cell phone.
Noninvasive diagnostics to assess anatomy and physiology
“I think coronary CT angiography [CTA] will become the new diagnostic angiogram,” he predicted. “CTA has gotten much better. Outside the United States, in Europe and particularly in Japan and increasingly in China, CTA is becoming extremely common.”
Dr. King cited a recent multicenter study of blinded heart team treatment decision making on the basis of either CTA or conventional invasive angiography in 223 patients with left main or triple-vessel coronary artery disease (CAD). The level of agreement was impressively high: Coronary artery bypass grafting (CABG) was recommended for 28% of patients on the basis of CTA and 26% with conventional angiography, which suggests the feasibility of treatment decision making based solely on noninvasive imaging, history, and clinical examination (Eur Heart J. 2018 Nov 1;39[41]:3689-98).
“The other thing I like about the potential for noninvasive imaging to guide our interventions is that it may [replace] the diagnostic angiogram, which has largely become extinct,” the cardiologist continued. “If you think about it, patients are referred for an angiogram, and as far as informed consent is concerned, the patient is told to pack his bags, go off to some other city, get in the cath lab, and take the family because of what they might do to you. They might put stents in you, they might operate on you. We don’t have any idea because we don’t know what you have. And the patient has to buy into this. With CTA, the potential is there for people to actually know what you’re going to do to them before you do it.”
Coronary artery calcium scoring for primary risk assessment has taken on a prominent role in the latest practice guidelines. “I think it’s mostly helpful in getting people out of the system because they don’t have any calcium,” in Dr. King’s view.
PET and MRI will remain secondary noninvasive technologies. They will be used mostly to diagnose microvascular disease, but that’s information that doesn’t have much influence on whether interventional procedures are performed.
Overall, he gave noninvasive diagnostic tools high marks for their potential to improve outcomes in patients with stable ischemic heart disease.
“I give it a pretty robust three bars. Maybe you could give it four,” he said.
New pharmacologic therapies
Citing in particular the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors and the sodium-glucose cotransporter 2 (SGLT2) inhibitors, Dr. King declared, “It may be that the biggest, newest device in interventional cardiology going forward is not a device at all, it’s medical therapy.”
Interventional cardiologists either need to become expert in advanced medical therapies or else have access to someone in their group who prescribes those medications deftly.
“The future care of our patients will require more than percutaneous coronary intervention,” he emphasized.
So, four bars for the new medical therapies.
PCI and coronary artery bypass surgery
Both get one bar.
“PCI will be a partner of advanced antiatherosclerotic therapies, but will not be replaced by limiting antianginal therapy to medical treatment only,” Dr. King predicted.
Regarding CABG, he highlighted a recent systematic review and pooled analysis of 11,518 patients with stable ischemic heart disease randomized to CABG or PCI using drug-eluting or bare-metal stents in 11 clinical trials. CABG demonstrated a significant mortality benefit over PCI in patients with multivessel disease, particularly among those with diabetes or a higher degree of coronary disease complexity. However, there was no benefit in terms of 5-year all-cause mortality for CABG over PCI in those with left main disease (Lancet. 2018 Mar 10;391[10124]:9399-48).
“CABG will not go away. I predict that about 25% of revascularizations will continue to be done by surgery,” the cardiologist said. “For patients who can have complete revascularization by PCI, it’ll be done with advanced technology, but probably only by a subset of operators. We have a huge number of interventional cardiologists in this country, and some of them do a lot of these kinds of cases and some don’t.”
Endovascular imaging to optimize stent deployment and characterize plaque
Studies suggest that the use of intravascular ultrasound and other endovascular imaging technologies ends up providing better results than when they’re not employed.
“We see greatly increased use of IVUS [intravascular ultrasound], and not so much of optical coherence tomography, because of technical problems. So I give this at least two bars as far as moving practice forward,” according to Dr. King.
Bioresorbable scaffolds
This technology, which he noted “was supposed to solve all of our problems,” has tripped and fallen because of its associated increased risk of scaffold thrombosis. He cited a recent network meta-analysis of 91 randomized, controlled trials comparing bioresorbable scaffolds to current-generation metallic drug-eluting stents in more than 105,000 patients. The bioresorbable scaffolds had a significantly higher rate of scaffold thrombosis in the first 30 days after implantation, as well as from 31 days through 1 year and also beyond 1 year. In fact, there was a rising trend for scaffold thrombosis in the bioresorbable device group after the 1 year mark through a mean 3.7 years of follow-up (EuroIntervention. 2018 Mar 20;13[16]:1904-13).
“The overall impact of bioresorbable scaffolds has been nil. We don’t have them. Bioresorbable scaffolds may become noninferior to the best metal stents, but to become mainstream, they should show superiority,” the cardiologist said.
One bar, based on the uncertain possibility that new bioresorbable scaffolds now in early stages of development ultimately pan out.
Future training needs
PCI operator volumes are low, and that raises a host of issues regarding future training needs. Should fewer interventionalists be trained? Should training in endovascular imaging be a mandatory part of PCI training? Should interventional cardiology be divided into distinct coronary, structural heart, and peripheral vascular subspecialty domains involving different people, a change that is already informally underway in many places? How are operators who are interested in becoming experts in PCI for chronic total occlusion, diffuse disease, left main disease, or other complex cases going to get enough experience to be able to concentrate in those areas?
These are questions that will need to be addressed in the coming years. The answers will surely affect the delivery of interventional cardiology care.
Dr. King reported having no financial conflicts regarding his presentation.
SOURCE: King SB.
EXPERT ANALYSIS FROM ACC SNOWMASS 2019
Destress dermatologic procedures with honesty, distraction, relaxation
according to a report published in Pediatric Dermatology.
For many children, the anticipation of pain and the anxiety about a procedure results in a more painful experience, wrote Andrew M. Armenta of the University of Texas, Galveston, and his colleagues. Preparing children in advance and using cognitive behavioral therapy (CBT) strategies in the moment can help reduce their anxiety.
“CBT is a skill‐based approach that focuses on the present and aims to teach efficient ways of identifying distorted thinking, modifying beliefs, and changing behaviors for a more favorable outcome of real‐life situations,” they wrote.
First, Dr. Armenta and his associates advised, be honest with children about what to expect from a procedure. Evidence does not support phrases such as, “It won’t hurt,” or “It will be over soon,” to reduce anxiety.
Timing the disclosure of a procedure and creating the appropriate setting also can help reduce anxiety. For very young children, short notice of a procedure is often best, with the promise of a small reward or outing afterward. Older children may want some advance notice so they can feel prepared, but their specific concerns should be addressed.
CBT-based techniques include deep breathing and positive coping statements such as “I can do this” for older children, or encouraging them to talk about a family pet or listen to music. Younger children may be distracted with pinwheels, rattles, or songs. “Additionally, in recent years, virtual reality headsets have even proved to be effective distractors, resulting in an overall reduction in both pain and fear,” Dr. Armenta and his associates noted.
Other useful strategies include allowing children to choose their position and location for an injection or procedure when possible. Small children may be able to sit on the lap of an adult, and older children may prefer sitting up to lying down. Avoid physical restraint unless it is absolutely necessary for safety, the researchers emphasized.
Incorporating CBT-based strategies of breathing and distraction with honesty and respectful disclosure of what is being done and why “not only makes practicing pediatric dermatology easier, but also can improve patient adherence to painful procedures,” they said.
No disclosure information was given.
SOURCE: Armenta AM et al. Pediatr Dermatol. 2019. doi: 10.1111/pde.13739.
according to a report published in Pediatric Dermatology.
For many children, the anticipation of pain and the anxiety about a procedure results in a more painful experience, wrote Andrew M. Armenta of the University of Texas, Galveston, and his colleagues. Preparing children in advance and using cognitive behavioral therapy (CBT) strategies in the moment can help reduce their anxiety.
“CBT is a skill‐based approach that focuses on the present and aims to teach efficient ways of identifying distorted thinking, modifying beliefs, and changing behaviors for a more favorable outcome of real‐life situations,” they wrote.
First, Dr. Armenta and his associates advised, be honest with children about what to expect from a procedure. Evidence does not support phrases such as, “It won’t hurt,” or “It will be over soon,” to reduce anxiety.
Timing the disclosure of a procedure and creating the appropriate setting also can help reduce anxiety. For very young children, short notice of a procedure is often best, with the promise of a small reward or outing afterward. Older children may want some advance notice so they can feel prepared, but their specific concerns should be addressed.
CBT-based techniques include deep breathing and positive coping statements such as “I can do this” for older children, or encouraging them to talk about a family pet or listen to music. Younger children may be distracted with pinwheels, rattles, or songs. “Additionally, in recent years, virtual reality headsets have even proved to be effective distractors, resulting in an overall reduction in both pain and fear,” Dr. Armenta and his associates noted.
Other useful strategies include allowing children to choose their position and location for an injection or procedure when possible. Small children may be able to sit on the lap of an adult, and older children may prefer sitting up to lying down. Avoid physical restraint unless it is absolutely necessary for safety, the researchers emphasized.
Incorporating CBT-based strategies of breathing and distraction with honesty and respectful disclosure of what is being done and why “not only makes practicing pediatric dermatology easier, but also can improve patient adherence to painful procedures,” they said.
No disclosure information was given.
SOURCE: Armenta AM et al. Pediatr Dermatol. 2019. doi: 10.1111/pde.13739.
according to a report published in Pediatric Dermatology.
For many children, the anticipation of pain and the anxiety about a procedure results in a more painful experience, wrote Andrew M. Armenta of the University of Texas, Galveston, and his colleagues. Preparing children in advance and using cognitive behavioral therapy (CBT) strategies in the moment can help reduce their anxiety.
“CBT is a skill‐based approach that focuses on the present and aims to teach efficient ways of identifying distorted thinking, modifying beliefs, and changing behaviors for a more favorable outcome of real‐life situations,” they wrote.
First, Dr. Armenta and his associates advised, be honest with children about what to expect from a procedure. Evidence does not support phrases such as, “It won’t hurt,” or “It will be over soon,” to reduce anxiety.
Timing the disclosure of a procedure and creating the appropriate setting also can help reduce anxiety. For very young children, short notice of a procedure is often best, with the promise of a small reward or outing afterward. Older children may want some advance notice so they can feel prepared, but their specific concerns should be addressed.
CBT-based techniques include deep breathing and positive coping statements such as “I can do this” for older children, or encouraging them to talk about a family pet or listen to music. Younger children may be distracted with pinwheels, rattles, or songs. “Additionally, in recent years, virtual reality headsets have even proved to be effective distractors, resulting in an overall reduction in both pain and fear,” Dr. Armenta and his associates noted.
Other useful strategies include allowing children to choose their position and location for an injection or procedure when possible. Small children may be able to sit on the lap of an adult, and older children may prefer sitting up to lying down. Avoid physical restraint unless it is absolutely necessary for safety, the researchers emphasized.
Incorporating CBT-based strategies of breathing and distraction with honesty and respectful disclosure of what is being done and why “not only makes practicing pediatric dermatology easier, but also can improve patient adherence to painful procedures,” they said.
No disclosure information was given.
SOURCE: Armenta AM et al. Pediatr Dermatol. 2019. doi: 10.1111/pde.13739.
FROM PEDIATRIC DERMATOLOGY
