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Regenerative medicine is likely game changer for cardiovascular disease
NEW ORLEANS – Regenerative medicine has much to offer the cardiovascular field, although there is still a way to go before it is ready for routine clinical application, according to Andre Terzic, MD, PhD, director of the Mayo Clinic Center for Regenerative Medicine and a professor in Cardiovascular Diseases Research at the Mayo Clinic, in Rochester, Minn.
Trials testing a variety of stem cell approaches in patients with conditions such as acute myocardial infarction, peripheral arterial disease, and dilated cardiomyopathy are providing important lessons about this novel strategy and showing its potential, he said in a state of the science talk at the American Heart Association scientific sessions.
Impact on therapeutic approaches and goals
“This is a true paradigm shift in how we are approaching patients from a more traditional fighting of disease, whether it’s in the vascular or cardiac arena, to ultimately really where regenerative medicine is driving: rebuilding vascular and heart health,” Dr. Terzic maintained.
Leaders in the field have put forth an associated value proposition, estimating that a decade from now, regenerative medicine will account for about 10% of all health care delivered globally, according to Dr. Terzic. And research presented at the meeting is a major step in that direction.
The potential applications in cardiovascular medicine are numerous, he proposed. Regenerative medicine might be used in prophylactic strategies, for protection against chronic disease, and in bridging strategies, to delay transplantation in patients with end organ damage. It might also be used in combination approaches, to augment the efficacy of primary therapy, and even to generate new organs for patients who have run out of options.
The specific therapeutic goals depend on the stage of disease. For example, the goal is to boost cardioprotection and limit inflammation in acute myocardial infarction; to augment myocardial regenerative reserve and improve survival in subacute disease; and to enhance the pro-reparative environment and restore structure and function in the setting of chronic cardiomyopathy.
Bringing regenerative medicine to the clinic
Ultimately, the health care field is striving to bring the science of regenerative medicine into the clinic, and turn the research pipeline into a clinical service line, Dr. Terzic said.
As might be expected, the whole process begins with identification of an unmet need in patients, which in turn generates a specific practice advancement goal. In the cardiovascular arena, the process has largely been driven by smaller collaborative groups and champions in the field, but is increasingly garnering new support from the business world and national networks.
“The importance at the moment is the experiences that are being built allow for a true iterative process in harnessing this new knowledge and essentially developing even more refined and more effective solutions as we look into the future,” Dr. Terzic commented.
“The cardiovascular field is clearly not alone, but is working in tandem with many other fields that are evolving rapidly in this area,” he added. “And I think the collective experience will be one of the main drivers as we build this shared vision for a practice not only for regenerative solutions, but for practice-integrated regenerative medicine, ultimately, as one of the models of care in the decade to come.”
A blueprint for moving forward
Dr. Terzic and his colleagues at the Mayo Clinic have developed a framework for advancing the field that is being used at their institution but could also be used elsewhere (Eur Heart J. 2016;37:1089-90).
“What we have historically been doing for the last decade or so is really building this discovery knowledge, and then moving it into translation and ultimately application,” he explained. “We call this a blueprint, a blueprint that has helped us all collectively get where we are today.”
For each of these three domains, investigators strive to build out the concept, starting with the specific regenerative technology or product, proceeding to its manufacture or production, and eventually devising ways to deliver it to patients through a clinical-grade supply chain available at the point of care.
“There is a new evolving concept of truly building a regenerative medicine care model,” summarized Dr. Terzic, who disclosed no relevant conflicts of interest. “Today, we are not fully there. We are really speaking about technological and translational readiness. But ultimately, the goal is to ensure clinical readiness.”
NEW ORLEANS – Regenerative medicine has much to offer the cardiovascular field, although there is still a way to go before it is ready for routine clinical application, according to Andre Terzic, MD, PhD, director of the Mayo Clinic Center for Regenerative Medicine and a professor in Cardiovascular Diseases Research at the Mayo Clinic, in Rochester, Minn.
Trials testing a variety of stem cell approaches in patients with conditions such as acute myocardial infarction, peripheral arterial disease, and dilated cardiomyopathy are providing important lessons about this novel strategy and showing its potential, he said in a state of the science talk at the American Heart Association scientific sessions.
Impact on therapeutic approaches and goals
“This is a true paradigm shift in how we are approaching patients from a more traditional fighting of disease, whether it’s in the vascular or cardiac arena, to ultimately really where regenerative medicine is driving: rebuilding vascular and heart health,” Dr. Terzic maintained.
Leaders in the field have put forth an associated value proposition, estimating that a decade from now, regenerative medicine will account for about 10% of all health care delivered globally, according to Dr. Terzic. And research presented at the meeting is a major step in that direction.
The potential applications in cardiovascular medicine are numerous, he proposed. Regenerative medicine might be used in prophylactic strategies, for protection against chronic disease, and in bridging strategies, to delay transplantation in patients with end organ damage. It might also be used in combination approaches, to augment the efficacy of primary therapy, and even to generate new organs for patients who have run out of options.
The specific therapeutic goals depend on the stage of disease. For example, the goal is to boost cardioprotection and limit inflammation in acute myocardial infarction; to augment myocardial regenerative reserve and improve survival in subacute disease; and to enhance the pro-reparative environment and restore structure and function in the setting of chronic cardiomyopathy.
Bringing regenerative medicine to the clinic
Ultimately, the health care field is striving to bring the science of regenerative medicine into the clinic, and turn the research pipeline into a clinical service line, Dr. Terzic said.
As might be expected, the whole process begins with identification of an unmet need in patients, which in turn generates a specific practice advancement goal. In the cardiovascular arena, the process has largely been driven by smaller collaborative groups and champions in the field, but is increasingly garnering new support from the business world and national networks.
“The importance at the moment is the experiences that are being built allow for a true iterative process in harnessing this new knowledge and essentially developing even more refined and more effective solutions as we look into the future,” Dr. Terzic commented.
“The cardiovascular field is clearly not alone, but is working in tandem with many other fields that are evolving rapidly in this area,” he added. “And I think the collective experience will be one of the main drivers as we build this shared vision for a practice not only for regenerative solutions, but for practice-integrated regenerative medicine, ultimately, as one of the models of care in the decade to come.”
A blueprint for moving forward
Dr. Terzic and his colleagues at the Mayo Clinic have developed a framework for advancing the field that is being used at their institution but could also be used elsewhere (Eur Heart J. 2016;37:1089-90).
“What we have historically been doing for the last decade or so is really building this discovery knowledge, and then moving it into translation and ultimately application,” he explained. “We call this a blueprint, a blueprint that has helped us all collectively get where we are today.”
For each of these three domains, investigators strive to build out the concept, starting with the specific regenerative technology or product, proceeding to its manufacture or production, and eventually devising ways to deliver it to patients through a clinical-grade supply chain available at the point of care.
“There is a new evolving concept of truly building a regenerative medicine care model,” summarized Dr. Terzic, who disclosed no relevant conflicts of interest. “Today, we are not fully there. We are really speaking about technological and translational readiness. But ultimately, the goal is to ensure clinical readiness.”
NEW ORLEANS – Regenerative medicine has much to offer the cardiovascular field, although there is still a way to go before it is ready for routine clinical application, according to Andre Terzic, MD, PhD, director of the Mayo Clinic Center for Regenerative Medicine and a professor in Cardiovascular Diseases Research at the Mayo Clinic, in Rochester, Minn.
Trials testing a variety of stem cell approaches in patients with conditions such as acute myocardial infarction, peripheral arterial disease, and dilated cardiomyopathy are providing important lessons about this novel strategy and showing its potential, he said in a state of the science talk at the American Heart Association scientific sessions.
Impact on therapeutic approaches and goals
“This is a true paradigm shift in how we are approaching patients from a more traditional fighting of disease, whether it’s in the vascular or cardiac arena, to ultimately really where regenerative medicine is driving: rebuilding vascular and heart health,” Dr. Terzic maintained.
Leaders in the field have put forth an associated value proposition, estimating that a decade from now, regenerative medicine will account for about 10% of all health care delivered globally, according to Dr. Terzic. And research presented at the meeting is a major step in that direction.
The potential applications in cardiovascular medicine are numerous, he proposed. Regenerative medicine might be used in prophylactic strategies, for protection against chronic disease, and in bridging strategies, to delay transplantation in patients with end organ damage. It might also be used in combination approaches, to augment the efficacy of primary therapy, and even to generate new organs for patients who have run out of options.
The specific therapeutic goals depend on the stage of disease. For example, the goal is to boost cardioprotection and limit inflammation in acute myocardial infarction; to augment myocardial regenerative reserve and improve survival in subacute disease; and to enhance the pro-reparative environment and restore structure and function in the setting of chronic cardiomyopathy.
Bringing regenerative medicine to the clinic
Ultimately, the health care field is striving to bring the science of regenerative medicine into the clinic, and turn the research pipeline into a clinical service line, Dr. Terzic said.
As might be expected, the whole process begins with identification of an unmet need in patients, which in turn generates a specific practice advancement goal. In the cardiovascular arena, the process has largely been driven by smaller collaborative groups and champions in the field, but is increasingly garnering new support from the business world and national networks.
“The importance at the moment is the experiences that are being built allow for a true iterative process in harnessing this new knowledge and essentially developing even more refined and more effective solutions as we look into the future,” Dr. Terzic commented.
“The cardiovascular field is clearly not alone, but is working in tandem with many other fields that are evolving rapidly in this area,” he added. “And I think the collective experience will be one of the main drivers as we build this shared vision for a practice not only for regenerative solutions, but for practice-integrated regenerative medicine, ultimately, as one of the models of care in the decade to come.”
A blueprint for moving forward
Dr. Terzic and his colleagues at the Mayo Clinic have developed a framework for advancing the field that is being used at their institution but could also be used elsewhere (Eur Heart J. 2016;37:1089-90).
“What we have historically been doing for the last decade or so is really building this discovery knowledge, and then moving it into translation and ultimately application,” he explained. “We call this a blueprint, a blueprint that has helped us all collectively get where we are today.”
For each of these three domains, investigators strive to build out the concept, starting with the specific regenerative technology or product, proceeding to its manufacture or production, and eventually devising ways to deliver it to patients through a clinical-grade supply chain available at the point of care.
“There is a new evolving concept of truly building a regenerative medicine care model,” summarized Dr. Terzic, who disclosed no relevant conflicts of interest. “Today, we are not fully there. We are really speaking about technological and translational readiness. But ultimately, the goal is to ensure clinical readiness.”
Key clinical point:
Major finding: Trials testing a variety of stem cell approaches in patients with conditions such as acute MI, PAD, and dilated cardiomyopathy are providing important lessons.
Data source: Expert analysis of current trials by Dr. Terzic.
Disclosures: Dr. Terzic disclosed that he had no relevant conflicts of interest.
Diabetes, ischemic heart disease, pain lead health spending
Diabetes, ischemic heart disease, and back and neck pain are the top three conditions accounting for the highest spending on personal health care in the United States, according to a report published online Dec. 27 in JAMA.
In addition, spending on pharmaceuticals – particularly diabetes therapies, antihypertensive drugs, and medications for hyperlipidemia – drove much of the massive increase in health care spending during the past 2 decades, said Joseph L. Dieleman, PhD, of the Institute for Health Metrics and Evaluation, University of Washington, Seattle, and his associates.
Recent increases in health care spending are well documented, but less is known about what is spent for individual conditions, in different health care settings, and in various patient age groups. To assess health care spending across these categories, the investigators collected and analyzed data for 1996 through 2013 from nationally representative surveys of households, nationally representative surveys of medical facilities, insurance claims, government budgets, and other official records.
They grouped the data into six type-of-care categories: inpatient care, ambulatory care, emergency department care, nursing facility care, dental care, and prescribed pharmaceuticals. “Spending on the six types of personal health care was then disaggregated across 155 mutually exclusive and collectively exhaustive conditions and 38 age and sex groups,” with each sex being divided into 5-year age groups, the researchers noted.
Based on these data, the investigators came to the following conclusions:
• Twenty conditions accounted for approximately 58% of personal health care spending, which totaled an estimated $1.2 trillion in 2013.
• More resources were spent on diabetes than any other condition in 2013, at an estimated $101.4 billion. Prescribed medications accounted for nearly 60% of diabetes costs.
• The second-highest amount of health care spending was for ischemic heart disease, which accounted for $88.1 billion in 2013. Most such spending occurred in inpatient settings.
• Low-back and neck pain, comprising the third-highest level of spending, cost an estimated $87.6 billion. Approximately 60% of this spending occurred in ambulatory settings.
• Among all 155 conditions, spending for diabetes and low-back and neck pain increased the most during the 18-year study period.
• Among all six types of care, spending on pharmaceuticals and emergency care increased the most during the study period.
It is important to note that for the purposes of this study, cancer was disaggregated into 29 separate conditions, and none of them placed in the top 20 for health care spending, Dr. Dieleman and his associates noted (JAMA. 2016;316[24]:2627-46. doi: 10.1001/jama.2016.16885).
When spending was categorized by patient age groups, working-age adults accounted for the greatest amount spent in 2013, estimated at $1,070.1 billion. But that was followed closely by patients aged 65 and older, who accounted for an estimated $796.5 billion, much of which was spent on care in nursing facilities. The smallest amount of health care spending was in children over age 1 and adolescents, who accounted for an estimated $233.5 billion.
Among the other study findings:
• Spending on pharmaceutical treatment of two conditions, hypertension and hyperlipidemia, increased at more than double the rate of total health care spending. It totaled an estimated $135.7 billion in 2013.
• Other top-20 conditions included falls, depression, skin disorders such as acne and eczema, sense disorders such as vision correction and hearing loss, dental care, urinary disorders, and lower respiratory tract infection.
This work was supported by the National Institute on Aging and the Vitality Institute. Dr. Dieleman and his associates reported having no relevant financial disclosures.
Dieleman et al. have “followed” the health care money, and the trail could ultimately lead to the United States changing how it spends a staggering, almost unimaginable amount – roughly $3.2 trillion in 2015 – on health care.
At the very least, their data indicate that the United States should pay more attention to managing physical pain, controlling the costs of pharmaceuticals, and promoting lifestyle interventions that prevent or ameliorate obesity and other factors contributing to diabetes and heart disease.
Ezekiel J. Emanuel, MD, is provost of the department of medical ethics and health policy at the Perelman School of Medicine and in the department of health care management at The Wharton School, University of Pennsylvania, Philadelphia. He reported receiving speaking fees from numerous industry sources. Dr. Emanuel made these remarks in an editorial comment accompanying Dr. Dieleman’s report (JAMA 2016;316:2604-6. doi: 10.1001/jama.2016.16739).
Dieleman et al. have “followed” the health care money, and the trail could ultimately lead to the United States changing how it spends a staggering, almost unimaginable amount – roughly $3.2 trillion in 2015 – on health care.
At the very least, their data indicate that the United States should pay more attention to managing physical pain, controlling the costs of pharmaceuticals, and promoting lifestyle interventions that prevent or ameliorate obesity and other factors contributing to diabetes and heart disease.
Ezekiel J. Emanuel, MD, is provost of the department of medical ethics and health policy at the Perelman School of Medicine and in the department of health care management at The Wharton School, University of Pennsylvania, Philadelphia. He reported receiving speaking fees from numerous industry sources. Dr. Emanuel made these remarks in an editorial comment accompanying Dr. Dieleman’s report (JAMA 2016;316:2604-6. doi: 10.1001/jama.2016.16739).
Dieleman et al. have “followed” the health care money, and the trail could ultimately lead to the United States changing how it spends a staggering, almost unimaginable amount – roughly $3.2 trillion in 2015 – on health care.
At the very least, their data indicate that the United States should pay more attention to managing physical pain, controlling the costs of pharmaceuticals, and promoting lifestyle interventions that prevent or ameliorate obesity and other factors contributing to diabetes and heart disease.
Ezekiel J. Emanuel, MD, is provost of the department of medical ethics and health policy at the Perelman School of Medicine and in the department of health care management at The Wharton School, University of Pennsylvania, Philadelphia. He reported receiving speaking fees from numerous industry sources. Dr. Emanuel made these remarks in an editorial comment accompanying Dr. Dieleman’s report (JAMA 2016;316:2604-6. doi: 10.1001/jama.2016.16739).
Diabetes, ischemic heart disease, and back and neck pain are the top three conditions accounting for the highest spending on personal health care in the United States, according to a report published online Dec. 27 in JAMA.
In addition, spending on pharmaceuticals – particularly diabetes therapies, antihypertensive drugs, and medications for hyperlipidemia – drove much of the massive increase in health care spending during the past 2 decades, said Joseph L. Dieleman, PhD, of the Institute for Health Metrics and Evaluation, University of Washington, Seattle, and his associates.
Recent increases in health care spending are well documented, but less is known about what is spent for individual conditions, in different health care settings, and in various patient age groups. To assess health care spending across these categories, the investigators collected and analyzed data for 1996 through 2013 from nationally representative surveys of households, nationally representative surveys of medical facilities, insurance claims, government budgets, and other official records.
They grouped the data into six type-of-care categories: inpatient care, ambulatory care, emergency department care, nursing facility care, dental care, and prescribed pharmaceuticals. “Spending on the six types of personal health care was then disaggregated across 155 mutually exclusive and collectively exhaustive conditions and 38 age and sex groups,” with each sex being divided into 5-year age groups, the researchers noted.
Based on these data, the investigators came to the following conclusions:
• Twenty conditions accounted for approximately 58% of personal health care spending, which totaled an estimated $1.2 trillion in 2013.
• More resources were spent on diabetes than any other condition in 2013, at an estimated $101.4 billion. Prescribed medications accounted for nearly 60% of diabetes costs.
• The second-highest amount of health care spending was for ischemic heart disease, which accounted for $88.1 billion in 2013. Most such spending occurred in inpatient settings.
• Low-back and neck pain, comprising the third-highest level of spending, cost an estimated $87.6 billion. Approximately 60% of this spending occurred in ambulatory settings.
• Among all 155 conditions, spending for diabetes and low-back and neck pain increased the most during the 18-year study period.
• Among all six types of care, spending on pharmaceuticals and emergency care increased the most during the study period.
It is important to note that for the purposes of this study, cancer was disaggregated into 29 separate conditions, and none of them placed in the top 20 for health care spending, Dr. Dieleman and his associates noted (JAMA. 2016;316[24]:2627-46. doi: 10.1001/jama.2016.16885).
When spending was categorized by patient age groups, working-age adults accounted for the greatest amount spent in 2013, estimated at $1,070.1 billion. But that was followed closely by patients aged 65 and older, who accounted for an estimated $796.5 billion, much of which was spent on care in nursing facilities. The smallest amount of health care spending was in children over age 1 and adolescents, who accounted for an estimated $233.5 billion.
Among the other study findings:
• Spending on pharmaceutical treatment of two conditions, hypertension and hyperlipidemia, increased at more than double the rate of total health care spending. It totaled an estimated $135.7 billion in 2013.
• Other top-20 conditions included falls, depression, skin disorders such as acne and eczema, sense disorders such as vision correction and hearing loss, dental care, urinary disorders, and lower respiratory tract infection.
This work was supported by the National Institute on Aging and the Vitality Institute. Dr. Dieleman and his associates reported having no relevant financial disclosures.
Diabetes, ischemic heart disease, and back and neck pain are the top three conditions accounting for the highest spending on personal health care in the United States, according to a report published online Dec. 27 in JAMA.
In addition, spending on pharmaceuticals – particularly diabetes therapies, antihypertensive drugs, and medications for hyperlipidemia – drove much of the massive increase in health care spending during the past 2 decades, said Joseph L. Dieleman, PhD, of the Institute for Health Metrics and Evaluation, University of Washington, Seattle, and his associates.
Recent increases in health care spending are well documented, but less is known about what is spent for individual conditions, in different health care settings, and in various patient age groups. To assess health care spending across these categories, the investigators collected and analyzed data for 1996 through 2013 from nationally representative surveys of households, nationally representative surveys of medical facilities, insurance claims, government budgets, and other official records.
They grouped the data into six type-of-care categories: inpatient care, ambulatory care, emergency department care, nursing facility care, dental care, and prescribed pharmaceuticals. “Spending on the six types of personal health care was then disaggregated across 155 mutually exclusive and collectively exhaustive conditions and 38 age and sex groups,” with each sex being divided into 5-year age groups, the researchers noted.
Based on these data, the investigators came to the following conclusions:
• Twenty conditions accounted for approximately 58% of personal health care spending, which totaled an estimated $1.2 trillion in 2013.
• More resources were spent on diabetes than any other condition in 2013, at an estimated $101.4 billion. Prescribed medications accounted for nearly 60% of diabetes costs.
• The second-highest amount of health care spending was for ischemic heart disease, which accounted for $88.1 billion in 2013. Most such spending occurred in inpatient settings.
• Low-back and neck pain, comprising the third-highest level of spending, cost an estimated $87.6 billion. Approximately 60% of this spending occurred in ambulatory settings.
• Among all 155 conditions, spending for diabetes and low-back and neck pain increased the most during the 18-year study period.
• Among all six types of care, spending on pharmaceuticals and emergency care increased the most during the study period.
It is important to note that for the purposes of this study, cancer was disaggregated into 29 separate conditions, and none of them placed in the top 20 for health care spending, Dr. Dieleman and his associates noted (JAMA. 2016;316[24]:2627-46. doi: 10.1001/jama.2016.16885).
When spending was categorized by patient age groups, working-age adults accounted for the greatest amount spent in 2013, estimated at $1,070.1 billion. But that was followed closely by patients aged 65 and older, who accounted for an estimated $796.5 billion, much of which was spent on care in nursing facilities. The smallest amount of health care spending was in children over age 1 and adolescents, who accounted for an estimated $233.5 billion.
Among the other study findings:
• Spending on pharmaceutical treatment of two conditions, hypertension and hyperlipidemia, increased at more than double the rate of total health care spending. It totaled an estimated $135.7 billion in 2013.
• Other top-20 conditions included falls, depression, skin disorders such as acne and eczema, sense disorders such as vision correction and hearing loss, dental care, urinary disorders, and lower respiratory tract infection.
This work was supported by the National Institute on Aging and the Vitality Institute. Dr. Dieleman and his associates reported having no relevant financial disclosures.
FROM JAMA
Key clinical point:
Major finding: More resources were spent on diabetes than any other condition in 2013, at an estimated $101.4 billion.
Data source: A comprehensive estimate of U.S. spending on personal health care, based on information collected from nationally representative surveys of households and medical facilities, government budgets, insurance claims, and official records from 1996 through 2013.
Disclosures: The National Institute on Aging and the Vitality Institute supported the work. Dr. Dieleman and his associates reported having no relevant financial disclosures.
Confirmation CT prevents unnecessary pulmonary nodule bronchoscopy
It’s probably a good idea to do a repeat CT the morning of a scheduled bronchoscopy to make sure the pulmonary nodule is still there, according to investigators from Johns Hopkins University, Baltimore.
From Jan. 2015 to June 2016, 116 patients there were scheduled for navigational bronchoscopy to diagnose pulmonary lesions found on screening CTs. Eight (6.9%) – four men, four women, with an average age of 50 years – had a decrease in size or resolution of their lesion on confirmatory CT, leading to cancellations of their procedure. The number needed to screen to prevent one unnecessary procedure was 15. For canceled cases, the average time from screening CT to scheduled bronchoscopy was 53 days; for patients who underwent a bronchoscopy, it was 50 days (Ann Am Thorac Soc. 2016 Dec;13[12]:2223-8).
It can take months to schedule a bronchoscopy after a pulmonary nodule is found on CT screening. Once in a while, the investigators and others have found, even suspicious nodules resolve on their own, and patients end up having a bronchoscopy they don’t need.
“If there is a significant delay from the initial imaging, practitioners should consider repeat studies before proceeding with the scheduled procedure ... Same-day imaging may decrease unnecessary procedural risk ... The optimal time that should be allowed to pass is difficult to ascertain,” said investigators led by Roy Semaan, MD, of the division of pulmonary and critical care medicine at Hopkins.
The team used a newer version of electromagnetic navigation bronchoscopy (Veran Medical Technologies, St. Louis), which requires expiratory and inspiratory CTs the morning of the procedure so software can build a virtual airway model to localize the nodule.
In addition to nodule resolution, same-day CTs might identify disease progression that alters the diagnostic plan of care.
“The most obvious risk associated with repeat CT imaging is the increased radiation exposure to the patient. Patients in our study who received inspiratory and expiratory CT scans ... had a mean exposure of 9.485 mSv, which is not “negligible, but one-time doses at this range are generally considered to be low risk for contributing to the future development of a malignancy,” the team said.
The extra cost of a same-day noncontrast chest CT – about $300, the authors said – is more than offset if it cancels “an unnecessary procedure with its associated risks,” they said.
Dr. Semaan had no disclosures. Three investigators reported grants and personal fees from Veran.
It’s probably a good idea to do a repeat CT the morning of a scheduled bronchoscopy to make sure the pulmonary nodule is still there, according to investigators from Johns Hopkins University, Baltimore.
From Jan. 2015 to June 2016, 116 patients there were scheduled for navigational bronchoscopy to diagnose pulmonary lesions found on screening CTs. Eight (6.9%) – four men, four women, with an average age of 50 years – had a decrease in size or resolution of their lesion on confirmatory CT, leading to cancellations of their procedure. The number needed to screen to prevent one unnecessary procedure was 15. For canceled cases, the average time from screening CT to scheduled bronchoscopy was 53 days; for patients who underwent a bronchoscopy, it was 50 days (Ann Am Thorac Soc. 2016 Dec;13[12]:2223-8).
It can take months to schedule a bronchoscopy after a pulmonary nodule is found on CT screening. Once in a while, the investigators and others have found, even suspicious nodules resolve on their own, and patients end up having a bronchoscopy they don’t need.
“If there is a significant delay from the initial imaging, practitioners should consider repeat studies before proceeding with the scheduled procedure ... Same-day imaging may decrease unnecessary procedural risk ... The optimal time that should be allowed to pass is difficult to ascertain,” said investigators led by Roy Semaan, MD, of the division of pulmonary and critical care medicine at Hopkins.
The team used a newer version of electromagnetic navigation bronchoscopy (Veran Medical Technologies, St. Louis), which requires expiratory and inspiratory CTs the morning of the procedure so software can build a virtual airway model to localize the nodule.
In addition to nodule resolution, same-day CTs might identify disease progression that alters the diagnostic plan of care.
“The most obvious risk associated with repeat CT imaging is the increased radiation exposure to the patient. Patients in our study who received inspiratory and expiratory CT scans ... had a mean exposure of 9.485 mSv, which is not “negligible, but one-time doses at this range are generally considered to be low risk for contributing to the future development of a malignancy,” the team said.
The extra cost of a same-day noncontrast chest CT – about $300, the authors said – is more than offset if it cancels “an unnecessary procedure with its associated risks,” they said.
Dr. Semaan had no disclosures. Three investigators reported grants and personal fees from Veran.
It’s probably a good idea to do a repeat CT the morning of a scheduled bronchoscopy to make sure the pulmonary nodule is still there, according to investigators from Johns Hopkins University, Baltimore.
From Jan. 2015 to June 2016, 116 patients there were scheduled for navigational bronchoscopy to diagnose pulmonary lesions found on screening CTs. Eight (6.9%) – four men, four women, with an average age of 50 years – had a decrease in size or resolution of their lesion on confirmatory CT, leading to cancellations of their procedure. The number needed to screen to prevent one unnecessary procedure was 15. For canceled cases, the average time from screening CT to scheduled bronchoscopy was 53 days; for patients who underwent a bronchoscopy, it was 50 days (Ann Am Thorac Soc. 2016 Dec;13[12]:2223-8).
It can take months to schedule a bronchoscopy after a pulmonary nodule is found on CT screening. Once in a while, the investigators and others have found, even suspicious nodules resolve on their own, and patients end up having a bronchoscopy they don’t need.
“If there is a significant delay from the initial imaging, practitioners should consider repeat studies before proceeding with the scheduled procedure ... Same-day imaging may decrease unnecessary procedural risk ... The optimal time that should be allowed to pass is difficult to ascertain,” said investigators led by Roy Semaan, MD, of the division of pulmonary and critical care medicine at Hopkins.
The team used a newer version of electromagnetic navigation bronchoscopy (Veran Medical Technologies, St. Louis), which requires expiratory and inspiratory CTs the morning of the procedure so software can build a virtual airway model to localize the nodule.
In addition to nodule resolution, same-day CTs might identify disease progression that alters the diagnostic plan of care.
“The most obvious risk associated with repeat CT imaging is the increased radiation exposure to the patient. Patients in our study who received inspiratory and expiratory CT scans ... had a mean exposure of 9.485 mSv, which is not “negligible, but one-time doses at this range are generally considered to be low risk for contributing to the future development of a malignancy,” the team said.
The extra cost of a same-day noncontrast chest CT – about $300, the authors said – is more than offset if it cancels “an unnecessary procedure with its associated risks,” they said.
Dr. Semaan had no disclosures. Three investigators reported grants and personal fees from Veran.
Key clinical point:
Major finding: Of 116 patients, eight (6.9%) – four men, four women, average age 50 years – had a decrease in size or resolution of their lesion on confirmatory CT, leading to cancellation of their procedure.
Data source: Prospective series from Johns Hopkins University.
Disclosures: Three investigators reported grants and personal fees from Veran.
Coronary revascularization appropriate use criteria updated
For ST segment–elevation myocardial infarction (STEMI) patients presenting between 12 and 24 hours from symptom onset but with no signs of clinical instability, coronary revascularization “may be appropriate,” according to a new report. At the same time, for STEMI patients initially treated with fibrinolysis, revascularization was rated as “appropriate therapy” in the setting of suspected failed fibrinolytic therapy or in stable and asymptomatic patients from 3 to 24 hours after fibrinolysis.
Those are two conclusions contained in a revision of the appropriate use criteria (AUC) for coronary revascularization published on Dec. 21 (J Am Coll Cardiol. doi: 10.1016/j.jacc.2016.10.034).
“This update provides a reassessment of clinical scenarios that the writing group felt to be affected by significant changes in the medical literature or gaps from prior criteria,” Manesh R. Patel, MD, chief of the division of cardiology and codirector of the Duke Heart Center at Duke University, Durham, N.C., and chair of the seven-member writing committee for the document, said in a prepared statement. “The primary objective of the appropriate use criteria is to provide a framework for the assessment of practice patterns that will hopefully improve physician decision making and ultimately lead to better patient outcomes.”
The 22-page document contains 17 clinical scenarios that were scored by a separate committee of 17 experts to indicate whether revascularization in patients with acute coronary syndromes is appropriate, may be appropriate, or is rarely appropriate for the clinical scenario presented. Step-by-step flow charts are included to help use the criteria. “Since publication of the 2012 AUC document (J Am Coll Cardiol. 2012;59:857-81), new guidelines for [STEMI] and non–ST segment elevation myocardial infarction (NSTEMI)/unstable angina have been published with additional focused updates of the [stable ischemic heart disease] guideline and a combined focused update of the percutaneous coronary intervention (PCI) and STEMI guideline,” the writing committee noted. “New clinical trials have been published extending the knowledge and evidence around coronary revascularization, including trials that challenge earlier recommendations about the timing of nonculprit vessel PCI in the setting of STEMI. Additional studies related to coronary artery bypass graft surgery, medical therapy, and diagnostic technologies such as fractional flow reserve (FFR) have emerged as well as analyses from the National Cardiovascular Data Registry (NCDR) on the existing AUC that provide insights into practice patterns, clinical scenarios, and patient features not previously addressed.”
Conclusions in the document include those for nonculprit artery revascularization during the index hospitalization after primary PCI or fibrinolysis. This was rated as “appropriate and reasonable” for patients with one or more severe stenoses and spontaneous or easily provoked ischemia or for asymptomatic patients with ischemic findings on noninvasive testing. Meanwhile, in the presence of an intermediate-severity nonculprit artery stenosis, revascularization was rated as “appropriate therapy” in cases where the fractional flow reserve is at or below 0.80. For patients who are stable and asymptomatic after primary PCI, revascularization was rated as “may be appropriate” for one or more severe stenoses even in the absence of further testing.
The only “rarely appropriate” rating in patients with acute coronary syndromes occurred for asymptomatic patients with intermediate-severity nonculprit artery stenoses in the absence of any additional testing to demonstrate the functional significance of the stenosis.
“As in prior versions of the AUC, these revascularization ratings should be used to reinforce existing management strategies and identify patient populations that need more information to identify the most effective treatments,” the authors concluded. Dr. Patel reported having no financial disclosures.
For ST segment–elevation myocardial infarction (STEMI) patients presenting between 12 and 24 hours from symptom onset but with no signs of clinical instability, coronary revascularization “may be appropriate,” according to a new report. At the same time, for STEMI patients initially treated with fibrinolysis, revascularization was rated as “appropriate therapy” in the setting of suspected failed fibrinolytic therapy or in stable and asymptomatic patients from 3 to 24 hours after fibrinolysis.
Those are two conclusions contained in a revision of the appropriate use criteria (AUC) for coronary revascularization published on Dec. 21 (J Am Coll Cardiol. doi: 10.1016/j.jacc.2016.10.034).
“This update provides a reassessment of clinical scenarios that the writing group felt to be affected by significant changes in the medical literature or gaps from prior criteria,” Manesh R. Patel, MD, chief of the division of cardiology and codirector of the Duke Heart Center at Duke University, Durham, N.C., and chair of the seven-member writing committee for the document, said in a prepared statement. “The primary objective of the appropriate use criteria is to provide a framework for the assessment of practice patterns that will hopefully improve physician decision making and ultimately lead to better patient outcomes.”
The 22-page document contains 17 clinical scenarios that were scored by a separate committee of 17 experts to indicate whether revascularization in patients with acute coronary syndromes is appropriate, may be appropriate, or is rarely appropriate for the clinical scenario presented. Step-by-step flow charts are included to help use the criteria. “Since publication of the 2012 AUC document (J Am Coll Cardiol. 2012;59:857-81), new guidelines for [STEMI] and non–ST segment elevation myocardial infarction (NSTEMI)/unstable angina have been published with additional focused updates of the [stable ischemic heart disease] guideline and a combined focused update of the percutaneous coronary intervention (PCI) and STEMI guideline,” the writing committee noted. “New clinical trials have been published extending the knowledge and evidence around coronary revascularization, including trials that challenge earlier recommendations about the timing of nonculprit vessel PCI in the setting of STEMI. Additional studies related to coronary artery bypass graft surgery, medical therapy, and diagnostic technologies such as fractional flow reserve (FFR) have emerged as well as analyses from the National Cardiovascular Data Registry (NCDR) on the existing AUC that provide insights into practice patterns, clinical scenarios, and patient features not previously addressed.”
Conclusions in the document include those for nonculprit artery revascularization during the index hospitalization after primary PCI or fibrinolysis. This was rated as “appropriate and reasonable” for patients with one or more severe stenoses and spontaneous or easily provoked ischemia or for asymptomatic patients with ischemic findings on noninvasive testing. Meanwhile, in the presence of an intermediate-severity nonculprit artery stenosis, revascularization was rated as “appropriate therapy” in cases where the fractional flow reserve is at or below 0.80. For patients who are stable and asymptomatic after primary PCI, revascularization was rated as “may be appropriate” for one or more severe stenoses even in the absence of further testing.
The only “rarely appropriate” rating in patients with acute coronary syndromes occurred for asymptomatic patients with intermediate-severity nonculprit artery stenoses in the absence of any additional testing to demonstrate the functional significance of the stenosis.
“As in prior versions of the AUC, these revascularization ratings should be used to reinforce existing management strategies and identify patient populations that need more information to identify the most effective treatments,” the authors concluded. Dr. Patel reported having no financial disclosures.
For ST segment–elevation myocardial infarction (STEMI) patients presenting between 12 and 24 hours from symptom onset but with no signs of clinical instability, coronary revascularization “may be appropriate,” according to a new report. At the same time, for STEMI patients initially treated with fibrinolysis, revascularization was rated as “appropriate therapy” in the setting of suspected failed fibrinolytic therapy or in stable and asymptomatic patients from 3 to 24 hours after fibrinolysis.
Those are two conclusions contained in a revision of the appropriate use criteria (AUC) for coronary revascularization published on Dec. 21 (J Am Coll Cardiol. doi: 10.1016/j.jacc.2016.10.034).
“This update provides a reassessment of clinical scenarios that the writing group felt to be affected by significant changes in the medical literature or gaps from prior criteria,” Manesh R. Patel, MD, chief of the division of cardiology and codirector of the Duke Heart Center at Duke University, Durham, N.C., and chair of the seven-member writing committee for the document, said in a prepared statement. “The primary objective of the appropriate use criteria is to provide a framework for the assessment of practice patterns that will hopefully improve physician decision making and ultimately lead to better patient outcomes.”
The 22-page document contains 17 clinical scenarios that were scored by a separate committee of 17 experts to indicate whether revascularization in patients with acute coronary syndromes is appropriate, may be appropriate, or is rarely appropriate for the clinical scenario presented. Step-by-step flow charts are included to help use the criteria. “Since publication of the 2012 AUC document (J Am Coll Cardiol. 2012;59:857-81), new guidelines for [STEMI] and non–ST segment elevation myocardial infarction (NSTEMI)/unstable angina have been published with additional focused updates of the [stable ischemic heart disease] guideline and a combined focused update of the percutaneous coronary intervention (PCI) and STEMI guideline,” the writing committee noted. “New clinical trials have been published extending the knowledge and evidence around coronary revascularization, including trials that challenge earlier recommendations about the timing of nonculprit vessel PCI in the setting of STEMI. Additional studies related to coronary artery bypass graft surgery, medical therapy, and diagnostic technologies such as fractional flow reserve (FFR) have emerged as well as analyses from the National Cardiovascular Data Registry (NCDR) on the existing AUC that provide insights into practice patterns, clinical scenarios, and patient features not previously addressed.”
Conclusions in the document include those for nonculprit artery revascularization during the index hospitalization after primary PCI or fibrinolysis. This was rated as “appropriate and reasonable” for patients with one or more severe stenoses and spontaneous or easily provoked ischemia or for asymptomatic patients with ischemic findings on noninvasive testing. Meanwhile, in the presence of an intermediate-severity nonculprit artery stenosis, revascularization was rated as “appropriate therapy” in cases where the fractional flow reserve is at or below 0.80. For patients who are stable and asymptomatic after primary PCI, revascularization was rated as “may be appropriate” for one or more severe stenoses even in the absence of further testing.
The only “rarely appropriate” rating in patients with acute coronary syndromes occurred for asymptomatic patients with intermediate-severity nonculprit artery stenoses in the absence of any additional testing to demonstrate the functional significance of the stenosis.
“As in prior versions of the AUC, these revascularization ratings should be used to reinforce existing management strategies and identify patient populations that need more information to identify the most effective treatments,” the authors concluded. Dr. Patel reported having no financial disclosures.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
CMS finalizes cardiac pay bundles, but their future is unclear
The Centers for Medicare & Medicaid Services has finalized three cardiac payment bundles that will qualify as advanced alternative payment models under MACRA’s Quality Payment Program, but questions linger as to whether the bundles will survive in the Trump administration.
The bundles include the Acute Myocardial Infarction (AMI) model, the Coronary Artery Bypass Graft (CABG) model, and the Cardiac Rehabilitation Incentive Payment model. The three programs were proposed in July 2016 and finalized in a rule posted Dec. 20, and scheduled for publication in the Federal Register on Jan. 3, 2017.
The bundled payment model will place accountability for patient outcomes 90 days after discharge on the hospital where treatment occurred. Beginning July 1, 2017, hospitals in 98 randomly selected metropolitan statistical areas will be placed under this model and monitored for 5 years to test whether the model leads to improved outcomes and lower costs.
Physician participation will be voluntary; those who do participate will eligible for bonus payments as part of a Quality Payment Program advanced Alternative Payment Model (APM) when savings are generated, and responsible for penalties when costs exceed targets. Physician participation would begin in 2018.
CMS also finalized a program to test whether an incentive payment will increase the use of cardiac rehabilitation services.
Participating hospitals will receive an initial payment of $25 per cardiac rehabilitation service for each of the first 11 services paid for by Medicare post-AMI or post-CABG, and $175 per service during the care period after 11 services. The care period runs parallel with the 90-day period for the AMI and CABG episode payment bundled.
“As we move from volume-based care to value-based care, this new path for cardiologists to participate in advanced alternative payment models under MACRA’s Quality Payment Program is a challenging step,” American College of Cardiology President Richard A. Chazal, MD, said in a statement. “It is our sincere hope that the end result will be opportunities for coordinated care and improvement in quality, while also decreasing costs for patients with heart attack or who undergo bypass surgery.”
The final rule also will test the Medicare ACO Track 1+ model, an accountable care organization that qualifies as an APM but has a lower risk of penalty than other ACOs, starting in 2018.
These new programs could be short-lived, depending on the direction taken by the Trump Administration. Rep. Tom Price, MD (R-Ga.), the incoming administration’s choice to lead the Health & Human Services department, was a lead cosigner to a Sept. 29 letter to Dr. Conway and CMS Acting Administrator Andy Slavitt that called on the agency to “cease all current and future planned mandatory initiatives” generating from the Centers for Medicare and Medicaid Innovation, which is where the bundles were developed. The letter said that the mandatory models “overhaul major payment systems, commandeer clinical decision-making, and dramatically alter the delivery of care.”
During the teleconference, Dr. Conway avoided answering questions about how the incoming administration might handle these models.
The final rule also offered a new bundle for patients requiring surgery after a hip fracture and provided updates to the Comprehensive Care for Joint Replacement (CJR) model.
The Centers for Medicare & Medicaid Services has finalized three cardiac payment bundles that will qualify as advanced alternative payment models under MACRA’s Quality Payment Program, but questions linger as to whether the bundles will survive in the Trump administration.
The bundles include the Acute Myocardial Infarction (AMI) model, the Coronary Artery Bypass Graft (CABG) model, and the Cardiac Rehabilitation Incentive Payment model. The three programs were proposed in July 2016 and finalized in a rule posted Dec. 20, and scheduled for publication in the Federal Register on Jan. 3, 2017.
The bundled payment model will place accountability for patient outcomes 90 days after discharge on the hospital where treatment occurred. Beginning July 1, 2017, hospitals in 98 randomly selected metropolitan statistical areas will be placed under this model and monitored for 5 years to test whether the model leads to improved outcomes and lower costs.
Physician participation will be voluntary; those who do participate will eligible for bonus payments as part of a Quality Payment Program advanced Alternative Payment Model (APM) when savings are generated, and responsible for penalties when costs exceed targets. Physician participation would begin in 2018.
CMS also finalized a program to test whether an incentive payment will increase the use of cardiac rehabilitation services.
Participating hospitals will receive an initial payment of $25 per cardiac rehabilitation service for each of the first 11 services paid for by Medicare post-AMI or post-CABG, and $175 per service during the care period after 11 services. The care period runs parallel with the 90-day period for the AMI and CABG episode payment bundled.
“As we move from volume-based care to value-based care, this new path for cardiologists to participate in advanced alternative payment models under MACRA’s Quality Payment Program is a challenging step,” American College of Cardiology President Richard A. Chazal, MD, said in a statement. “It is our sincere hope that the end result will be opportunities for coordinated care and improvement in quality, while also decreasing costs for patients with heart attack or who undergo bypass surgery.”
The final rule also will test the Medicare ACO Track 1+ model, an accountable care organization that qualifies as an APM but has a lower risk of penalty than other ACOs, starting in 2018.
These new programs could be short-lived, depending on the direction taken by the Trump Administration. Rep. Tom Price, MD (R-Ga.), the incoming administration’s choice to lead the Health & Human Services department, was a lead cosigner to a Sept. 29 letter to Dr. Conway and CMS Acting Administrator Andy Slavitt that called on the agency to “cease all current and future planned mandatory initiatives” generating from the Centers for Medicare and Medicaid Innovation, which is where the bundles were developed. The letter said that the mandatory models “overhaul major payment systems, commandeer clinical decision-making, and dramatically alter the delivery of care.”
During the teleconference, Dr. Conway avoided answering questions about how the incoming administration might handle these models.
The final rule also offered a new bundle for patients requiring surgery after a hip fracture and provided updates to the Comprehensive Care for Joint Replacement (CJR) model.
The Centers for Medicare & Medicaid Services has finalized three cardiac payment bundles that will qualify as advanced alternative payment models under MACRA’s Quality Payment Program, but questions linger as to whether the bundles will survive in the Trump administration.
The bundles include the Acute Myocardial Infarction (AMI) model, the Coronary Artery Bypass Graft (CABG) model, and the Cardiac Rehabilitation Incentive Payment model. The three programs were proposed in July 2016 and finalized in a rule posted Dec. 20, and scheduled for publication in the Federal Register on Jan. 3, 2017.
The bundled payment model will place accountability for patient outcomes 90 days after discharge on the hospital where treatment occurred. Beginning July 1, 2017, hospitals in 98 randomly selected metropolitan statistical areas will be placed under this model and monitored for 5 years to test whether the model leads to improved outcomes and lower costs.
Physician participation will be voluntary; those who do participate will eligible for bonus payments as part of a Quality Payment Program advanced Alternative Payment Model (APM) when savings are generated, and responsible for penalties when costs exceed targets. Physician participation would begin in 2018.
CMS also finalized a program to test whether an incentive payment will increase the use of cardiac rehabilitation services.
Participating hospitals will receive an initial payment of $25 per cardiac rehabilitation service for each of the first 11 services paid for by Medicare post-AMI or post-CABG, and $175 per service during the care period after 11 services. The care period runs parallel with the 90-day period for the AMI and CABG episode payment bundled.
“As we move from volume-based care to value-based care, this new path for cardiologists to participate in advanced alternative payment models under MACRA’s Quality Payment Program is a challenging step,” American College of Cardiology President Richard A. Chazal, MD, said in a statement. “It is our sincere hope that the end result will be opportunities for coordinated care and improvement in quality, while also decreasing costs for patients with heart attack or who undergo bypass surgery.”
The final rule also will test the Medicare ACO Track 1+ model, an accountable care organization that qualifies as an APM but has a lower risk of penalty than other ACOs, starting in 2018.
These new programs could be short-lived, depending on the direction taken by the Trump Administration. Rep. Tom Price, MD (R-Ga.), the incoming administration’s choice to lead the Health & Human Services department, was a lead cosigner to a Sept. 29 letter to Dr. Conway and CMS Acting Administrator Andy Slavitt that called on the agency to “cease all current and future planned mandatory initiatives” generating from the Centers for Medicare and Medicaid Innovation, which is where the bundles were developed. The letter said that the mandatory models “overhaul major payment systems, commandeer clinical decision-making, and dramatically alter the delivery of care.”
During the teleconference, Dr. Conway avoided answering questions about how the incoming administration might handle these models.
The final rule also offered a new bundle for patients requiring surgery after a hip fracture and provided updates to the Comprehensive Care for Joint Replacement (CJR) model.
FDA eases mental health warnings in smoking cessation drugs’ labels
Labels on two smoking cessation treatments will offer less severe warnings for mental health risk potentials in people with no history of psychiatric disorders, the Food and Drug Administration has announced.
Varenicline (Chantix) will no longer include a boxed warning for serious mental health side effects. The label for bupropion (Zyban) will still include a boxed warning, but language describing the potential for serious psychiatric adverse events will no longer appear within it. Updates will also be made to both labels to describe side effects on mood, behavior, or thinking.
In addition, varenicline’s label will reflect trial data showing its superior efficacy, compared with oral bupropion or nicotine patch. Although a patient medication guide will still be included with each prescription, the risk evaluation and mitigation strategy that prompted the guide will no longer be in place.
Earlier this year, two FDA advisory committees voted in favor of updating varenicline’s label, based on data from a randomized, controlled trial of more than 8,000 smokers, half of whom had a history of psychiatric disorders.
The trial showed no clinically significant difference in risk of adverse events across the smoking cessation treatments varenicline, bupropion, nicotine patch, or placebo study arms, although the risk was higher in the psychiatric cohorts in each.
Overall, 2% of those without a history of mental illness experienced neuropsychiatric adverse events, compared with between 5% and 7% of those with such a history.
The trial was cosponsored by Pfizer, maker of Chantix, and GlaxoSmithKline, maker of Zyban.
The FDA approved varenicline for smoking cessation in 2006 and approved bupropion, which also is indicated to treat depression and seasonal affective disorder, in 1997. After numerous postmarketing reports of increased incidents of psychiatric disorders occurring in smokers who used either drug, the agency added the boxed warning to each in 2009.
FDA officials advised clinicians to guard against changes in mental health status in smokers using these therapies. However, “the results of the trial confirm that the benefits of stopping smoking outweigh the risks of these medicines,” they noted.
On Twitter @whitneymcknight
Labels on two smoking cessation treatments will offer less severe warnings for mental health risk potentials in people with no history of psychiatric disorders, the Food and Drug Administration has announced.
Varenicline (Chantix) will no longer include a boxed warning for serious mental health side effects. The label for bupropion (Zyban) will still include a boxed warning, but language describing the potential for serious psychiatric adverse events will no longer appear within it. Updates will also be made to both labels to describe side effects on mood, behavior, or thinking.
In addition, varenicline’s label will reflect trial data showing its superior efficacy, compared with oral bupropion or nicotine patch. Although a patient medication guide will still be included with each prescription, the risk evaluation and mitigation strategy that prompted the guide will no longer be in place.
Earlier this year, two FDA advisory committees voted in favor of updating varenicline’s label, based on data from a randomized, controlled trial of more than 8,000 smokers, half of whom had a history of psychiatric disorders.
The trial showed no clinically significant difference in risk of adverse events across the smoking cessation treatments varenicline, bupropion, nicotine patch, or placebo study arms, although the risk was higher in the psychiatric cohorts in each.
Overall, 2% of those without a history of mental illness experienced neuropsychiatric adverse events, compared with between 5% and 7% of those with such a history.
The trial was cosponsored by Pfizer, maker of Chantix, and GlaxoSmithKline, maker of Zyban.
The FDA approved varenicline for smoking cessation in 2006 and approved bupropion, which also is indicated to treat depression and seasonal affective disorder, in 1997. After numerous postmarketing reports of increased incidents of psychiatric disorders occurring in smokers who used either drug, the agency added the boxed warning to each in 2009.
FDA officials advised clinicians to guard against changes in mental health status in smokers using these therapies. However, “the results of the trial confirm that the benefits of stopping smoking outweigh the risks of these medicines,” they noted.
On Twitter @whitneymcknight
Labels on two smoking cessation treatments will offer less severe warnings for mental health risk potentials in people with no history of psychiatric disorders, the Food and Drug Administration has announced.
Varenicline (Chantix) will no longer include a boxed warning for serious mental health side effects. The label for bupropion (Zyban) will still include a boxed warning, but language describing the potential for serious psychiatric adverse events will no longer appear within it. Updates will also be made to both labels to describe side effects on mood, behavior, or thinking.
In addition, varenicline’s label will reflect trial data showing its superior efficacy, compared with oral bupropion or nicotine patch. Although a patient medication guide will still be included with each prescription, the risk evaluation and mitigation strategy that prompted the guide will no longer be in place.
Earlier this year, two FDA advisory committees voted in favor of updating varenicline’s label, based on data from a randomized, controlled trial of more than 8,000 smokers, half of whom had a history of psychiatric disorders.
The trial showed no clinically significant difference in risk of adverse events across the smoking cessation treatments varenicline, bupropion, nicotine patch, or placebo study arms, although the risk was higher in the psychiatric cohorts in each.
Overall, 2% of those without a history of mental illness experienced neuropsychiatric adverse events, compared with between 5% and 7% of those with such a history.
The trial was cosponsored by Pfizer, maker of Chantix, and GlaxoSmithKline, maker of Zyban.
The FDA approved varenicline for smoking cessation in 2006 and approved bupropion, which also is indicated to treat depression and seasonal affective disorder, in 1997. After numerous postmarketing reports of increased incidents of psychiatric disorders occurring in smokers who used either drug, the agency added the boxed warning to each in 2009.
FDA officials advised clinicians to guard against changes in mental health status in smokers using these therapies. However, “the results of the trial confirm that the benefits of stopping smoking outweigh the risks of these medicines,” they noted.
On Twitter @whitneymcknight
Severe postoperative pain following thoracotomy predicts persistent pain months later
Patients who suffer from severe pain in the days immediately following an open thoracotomy are significantly more likely to still be experiencing pain from the procedure 6 months later, according to a study published in the Journal of Clinical Anesthesia.
“A recognized cause of persistent postsurgical pain is poorly controlled immediate postoperative pain,” wrote the authors, led by Gopinath Niraj, MD, of the University Hospitals of Leicester (England) NHS Trust. “Open thoracotomy can induce significant pain during the immediate postoperative period. Patients undergoing thoracotomy also have one of the greatest incidences of chronic postoperative pain and disability among all the surgical procedures.”
Dr. Niraj and his coinvestigators conducted an audit on 504 patients who underwent open thoracotomy at a single center between May 2010 and April 2012. The audit consisted of a questionnaire composed of 15 questions, which asked yes/no questions about the existence of and location of postoperative pain, and numerical questions regarding the severity of pain. Scores of 7 or higher on a 10-point scale indicated “severe pain,” according to the investigators (J Clin Anesth. 2017;36:174-7). Subjects were evaluated at 72 hours and at 6 months after the operation.
Of the 504 patients, there were 364 survivors, of which 306 received questionnaires. Of those 306, 133 (43%) reported at least five incidents of severe pain within 72 hours of undergoing the operation. Within this group, 109 (82%) reported feeling some amount of persistent pain 6 months later. Chronic post-thoracotomy pain was considered severe in 10% of those subjects, while 24% reported it as moderate and 48% said it was mild.
A total of 289 of the 306 subjects (95%) received an epidural analgesic in the 72 hours after thoracotomy. In terms of satisfaction with pain management, patients were overall positive; 36.3% rated it “excellent,” 43.8% called it “good,” while only 15.8% said it was “fair” and 3.8% said it was “poor.”
“Our audit has some limitations,” the authors noted. “The retrospective project relied on patient self-report and recall.”
Dr. Niraj and his coauthors did not report any financial conflicts. No funding sources for this study were disclosed.
Patients who suffer from severe pain in the days immediately following an open thoracotomy are significantly more likely to still be experiencing pain from the procedure 6 months later, according to a study published in the Journal of Clinical Anesthesia.
“A recognized cause of persistent postsurgical pain is poorly controlled immediate postoperative pain,” wrote the authors, led by Gopinath Niraj, MD, of the University Hospitals of Leicester (England) NHS Trust. “Open thoracotomy can induce significant pain during the immediate postoperative period. Patients undergoing thoracotomy also have one of the greatest incidences of chronic postoperative pain and disability among all the surgical procedures.”
Dr. Niraj and his coinvestigators conducted an audit on 504 patients who underwent open thoracotomy at a single center between May 2010 and April 2012. The audit consisted of a questionnaire composed of 15 questions, which asked yes/no questions about the existence of and location of postoperative pain, and numerical questions regarding the severity of pain. Scores of 7 or higher on a 10-point scale indicated “severe pain,” according to the investigators (J Clin Anesth. 2017;36:174-7). Subjects were evaluated at 72 hours and at 6 months after the operation.
Of the 504 patients, there were 364 survivors, of which 306 received questionnaires. Of those 306, 133 (43%) reported at least five incidents of severe pain within 72 hours of undergoing the operation. Within this group, 109 (82%) reported feeling some amount of persistent pain 6 months later. Chronic post-thoracotomy pain was considered severe in 10% of those subjects, while 24% reported it as moderate and 48% said it was mild.
A total of 289 of the 306 subjects (95%) received an epidural analgesic in the 72 hours after thoracotomy. In terms of satisfaction with pain management, patients were overall positive; 36.3% rated it “excellent,” 43.8% called it “good,” while only 15.8% said it was “fair” and 3.8% said it was “poor.”
“Our audit has some limitations,” the authors noted. “The retrospective project relied on patient self-report and recall.”
Dr. Niraj and his coauthors did not report any financial conflicts. No funding sources for this study were disclosed.
Patients who suffer from severe pain in the days immediately following an open thoracotomy are significantly more likely to still be experiencing pain from the procedure 6 months later, according to a study published in the Journal of Clinical Anesthesia.
“A recognized cause of persistent postsurgical pain is poorly controlled immediate postoperative pain,” wrote the authors, led by Gopinath Niraj, MD, of the University Hospitals of Leicester (England) NHS Trust. “Open thoracotomy can induce significant pain during the immediate postoperative period. Patients undergoing thoracotomy also have one of the greatest incidences of chronic postoperative pain and disability among all the surgical procedures.”
Dr. Niraj and his coinvestigators conducted an audit on 504 patients who underwent open thoracotomy at a single center between May 2010 and April 2012. The audit consisted of a questionnaire composed of 15 questions, which asked yes/no questions about the existence of and location of postoperative pain, and numerical questions regarding the severity of pain. Scores of 7 or higher on a 10-point scale indicated “severe pain,” according to the investigators (J Clin Anesth. 2017;36:174-7). Subjects were evaluated at 72 hours and at 6 months after the operation.
Of the 504 patients, there were 364 survivors, of which 306 received questionnaires. Of those 306, 133 (43%) reported at least five incidents of severe pain within 72 hours of undergoing the operation. Within this group, 109 (82%) reported feeling some amount of persistent pain 6 months later. Chronic post-thoracotomy pain was considered severe in 10% of those subjects, while 24% reported it as moderate and 48% said it was mild.
A total of 289 of the 306 subjects (95%) received an epidural analgesic in the 72 hours after thoracotomy. In terms of satisfaction with pain management, patients were overall positive; 36.3% rated it “excellent,” 43.8% called it “good,” while only 15.8% said it was “fair” and 3.8% said it was “poor.”
“Our audit has some limitations,” the authors noted. “The retrospective project relied on patient self-report and recall.”
Dr. Niraj and his coauthors did not report any financial conflicts. No funding sources for this study were disclosed.
FROM THE JOURNAL OF CLINICAL ANESTHESIA
Key clinical point:
Major finding: 133 of 306 patients were in severe pain 72 hours after thoracotomy; of these, 109 (82%) still had pain 6 months later.
Data source: Retrospective, single-center study of 504 thoracotomy patients between May 2010 and April 2012.
Disclosures: Authors reported no financial disclosures nor funding source.
Entresto cuts LV mass in hypertensive patients
NEW ORLEANS – Hypertensive patients without heart failure treated with the heart failure formulation sacubitril plus valsartan had a significantly greater drop in their left ventricular mass than did patients treated with olmesartan in a randomized trial with 114 patients.
Treatment with sacubitril plus valsartan for both 3 and 12 months led to roughly twice as much reduction in left ventricular (LV) mass as did treatment with olmesartan, and this difference persisted after adjustment for between-group differences in blood pressure reduction, Roland E. Schmieder, MD, reported at the American Heart Association Scientific Sessions.
During clinical development of sacubitril plus valsartan (Entresto), the company that owns this compound, Novartis, ran a few small studies using the formulation to treat hypertension, but eventually those studies stopped, he said in an interview. “I hope this pushes development of other neprilysin inhibitor formulations for their blood pressure effects. I think this finding helps us understand why sacubitril plus valsartan was so effective for treating heart failure.” (N Engl J Med. 2014 Sep 11;371[11]:933-1004.)
The study enrolled patients with mild or moderate hypertension; the average blood pressure of enrolled patients was 155/92 mm Hg. They averaged 60 years of age, two-thirds were men, and their average LV mass index at baseline was 72 g/m2. The study excluded patients with heart failure. Patients randomized to receive sacubitril plus valsartan began on a dose of 200 mg/day, and after 2 weeks this rose to 400 mg/day, the maximum recommended dosage in the labeling. Patients randomized to olmesartan began on 20 mg/day, and after 2 weeks their dosage increased to 40 mg/day. Patients in both arms were also eligible to receive amlodipine for additional blood pressure lowering if deemed necessary by the treating physician.
The sacubitril plus valsartan group patients had an average cut in systolic blood pressure of about 26 mm Hg, both 3 and 12 months after the start of treatment. Patients in the olmesartan arm had decreases of 23 mm Hg and 21 mm Hg, respectively, at the two follow-up times. These between-group differences were statistically significant, Dr. Schmieder said.
Measurement of LV mass index using MRI scans showed an average reduction of LV mass index, compared with baseline of 6.4 g/m2 and 6.8 g/m2 after 3 and 12 months of treatment with sacubitril plus valsartan, and average reductions from baseline of 2.3 g/m2 and 3.5 g/m2 at the two follow-up examinations for patients treated with olmesartan. These statistically significant differences remained after adjustment for degree of blood pressure reduction at 3 and 12 months.
Additional measurements showed no between-group differences in aortic distensibility, but central pulse pressure also showed a significantly greater reduction with sacubitril plus valsartan, compared with olmesartan.
The trial was investigator initiated and received funding from Novartis. Dr. Schmieder has received honoraria from Novartis and also from AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, and Servier.
[email protected]
On Twitter @mitchelzoler
This study produced very interesting and convincing data. The results suggested that treating hypertension with sacubitril plus valsartan produced a significant, incremental improvement in left ventricular mass beyond the formulation’s blood pressure effect. This could potentially have importance when treating patients with hypertension and left ventricular hypertrophy.
Olmesartan was a fair comparator to use. It arguably is the most potent angiotensin receptor blocker for reducing blood pressure. However, in routine practice we generally combine an angiotensin receptor blocker with a diuretic to get maximum blood pressure lowering. In addition, it is not new to show that blood pressure lowering reduces left ventricular size.
These data are too limited and the cost for prescribing sacubitril plus valsartan is so high, compared with most other antihypertensive drugs, that I would like to see additional study results documenting this effect before I’d be willing to prescribe sacubitril plus valsartan to patients with hypertension but no heart failure.
Dan J. Fintel, MD , a cardiologist and professor of medicine at Northwestern University in Chicago, made these comments in an interview. He has been a speaker on behalf of AstraZeneca, BMS, Daiichi Sankyo, Janssen, Merck, and Pfizer.
This study produced very interesting and convincing data. The results suggested that treating hypertension with sacubitril plus valsartan produced a significant, incremental improvement in left ventricular mass beyond the formulation’s blood pressure effect. This could potentially have importance when treating patients with hypertension and left ventricular hypertrophy.
Olmesartan was a fair comparator to use. It arguably is the most potent angiotensin receptor blocker for reducing blood pressure. However, in routine practice we generally combine an angiotensin receptor blocker with a diuretic to get maximum blood pressure lowering. In addition, it is not new to show that blood pressure lowering reduces left ventricular size.
These data are too limited and the cost for prescribing sacubitril plus valsartan is so high, compared with most other antihypertensive drugs, that I would like to see additional study results documenting this effect before I’d be willing to prescribe sacubitril plus valsartan to patients with hypertension but no heart failure.
Dan J. Fintel, MD , a cardiologist and professor of medicine at Northwestern University in Chicago, made these comments in an interview. He has been a speaker on behalf of AstraZeneca, BMS, Daiichi Sankyo, Janssen, Merck, and Pfizer.
This study produced very interesting and convincing data. The results suggested that treating hypertension with sacubitril plus valsartan produced a significant, incremental improvement in left ventricular mass beyond the formulation’s blood pressure effect. This could potentially have importance when treating patients with hypertension and left ventricular hypertrophy.
Olmesartan was a fair comparator to use. It arguably is the most potent angiotensin receptor blocker for reducing blood pressure. However, in routine practice we generally combine an angiotensin receptor blocker with a diuretic to get maximum blood pressure lowering. In addition, it is not new to show that blood pressure lowering reduces left ventricular size.
These data are too limited and the cost for prescribing sacubitril plus valsartan is so high, compared with most other antihypertensive drugs, that I would like to see additional study results documenting this effect before I’d be willing to prescribe sacubitril plus valsartan to patients with hypertension but no heart failure.
Dan J. Fintel, MD , a cardiologist and professor of medicine at Northwestern University in Chicago, made these comments in an interview. He has been a speaker on behalf of AstraZeneca, BMS, Daiichi Sankyo, Janssen, Merck, and Pfizer.
NEW ORLEANS – Hypertensive patients without heart failure treated with the heart failure formulation sacubitril plus valsartan had a significantly greater drop in their left ventricular mass than did patients treated with olmesartan in a randomized trial with 114 patients.
Treatment with sacubitril plus valsartan for both 3 and 12 months led to roughly twice as much reduction in left ventricular (LV) mass as did treatment with olmesartan, and this difference persisted after adjustment for between-group differences in blood pressure reduction, Roland E. Schmieder, MD, reported at the American Heart Association Scientific Sessions.
During clinical development of sacubitril plus valsartan (Entresto), the company that owns this compound, Novartis, ran a few small studies using the formulation to treat hypertension, but eventually those studies stopped, he said in an interview. “I hope this pushes development of other neprilysin inhibitor formulations for their blood pressure effects. I think this finding helps us understand why sacubitril plus valsartan was so effective for treating heart failure.” (N Engl J Med. 2014 Sep 11;371[11]:933-1004.)
The study enrolled patients with mild or moderate hypertension; the average blood pressure of enrolled patients was 155/92 mm Hg. They averaged 60 years of age, two-thirds were men, and their average LV mass index at baseline was 72 g/m2. The study excluded patients with heart failure. Patients randomized to receive sacubitril plus valsartan began on a dose of 200 mg/day, and after 2 weeks this rose to 400 mg/day, the maximum recommended dosage in the labeling. Patients randomized to olmesartan began on 20 mg/day, and after 2 weeks their dosage increased to 40 mg/day. Patients in both arms were also eligible to receive amlodipine for additional blood pressure lowering if deemed necessary by the treating physician.
The sacubitril plus valsartan group patients had an average cut in systolic blood pressure of about 26 mm Hg, both 3 and 12 months after the start of treatment. Patients in the olmesartan arm had decreases of 23 mm Hg and 21 mm Hg, respectively, at the two follow-up times. These between-group differences were statistically significant, Dr. Schmieder said.
Measurement of LV mass index using MRI scans showed an average reduction of LV mass index, compared with baseline of 6.4 g/m2 and 6.8 g/m2 after 3 and 12 months of treatment with sacubitril plus valsartan, and average reductions from baseline of 2.3 g/m2 and 3.5 g/m2 at the two follow-up examinations for patients treated with olmesartan. These statistically significant differences remained after adjustment for degree of blood pressure reduction at 3 and 12 months.
Additional measurements showed no between-group differences in aortic distensibility, but central pulse pressure also showed a significantly greater reduction with sacubitril plus valsartan, compared with olmesartan.
The trial was investigator initiated and received funding from Novartis. Dr. Schmieder has received honoraria from Novartis and also from AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, and Servier.
[email protected]
On Twitter @mitchelzoler
NEW ORLEANS – Hypertensive patients without heart failure treated with the heart failure formulation sacubitril plus valsartan had a significantly greater drop in their left ventricular mass than did patients treated with olmesartan in a randomized trial with 114 patients.
Treatment with sacubitril plus valsartan for both 3 and 12 months led to roughly twice as much reduction in left ventricular (LV) mass as did treatment with olmesartan, and this difference persisted after adjustment for between-group differences in blood pressure reduction, Roland E. Schmieder, MD, reported at the American Heart Association Scientific Sessions.
During clinical development of sacubitril plus valsartan (Entresto), the company that owns this compound, Novartis, ran a few small studies using the formulation to treat hypertension, but eventually those studies stopped, he said in an interview. “I hope this pushes development of other neprilysin inhibitor formulations for their blood pressure effects. I think this finding helps us understand why sacubitril plus valsartan was so effective for treating heart failure.” (N Engl J Med. 2014 Sep 11;371[11]:933-1004.)
The study enrolled patients with mild or moderate hypertension; the average blood pressure of enrolled patients was 155/92 mm Hg. They averaged 60 years of age, two-thirds were men, and their average LV mass index at baseline was 72 g/m2. The study excluded patients with heart failure. Patients randomized to receive sacubitril plus valsartan began on a dose of 200 mg/day, and after 2 weeks this rose to 400 mg/day, the maximum recommended dosage in the labeling. Patients randomized to olmesartan began on 20 mg/day, and after 2 weeks their dosage increased to 40 mg/day. Patients in both arms were also eligible to receive amlodipine for additional blood pressure lowering if deemed necessary by the treating physician.
The sacubitril plus valsartan group patients had an average cut in systolic blood pressure of about 26 mm Hg, both 3 and 12 months after the start of treatment. Patients in the olmesartan arm had decreases of 23 mm Hg and 21 mm Hg, respectively, at the two follow-up times. These between-group differences were statistically significant, Dr. Schmieder said.
Measurement of LV mass index using MRI scans showed an average reduction of LV mass index, compared with baseline of 6.4 g/m2 and 6.8 g/m2 after 3 and 12 months of treatment with sacubitril plus valsartan, and average reductions from baseline of 2.3 g/m2 and 3.5 g/m2 at the two follow-up examinations for patients treated with olmesartan. These statistically significant differences remained after adjustment for degree of blood pressure reduction at 3 and 12 months.
Additional measurements showed no between-group differences in aortic distensibility, but central pulse pressure also showed a significantly greater reduction with sacubitril plus valsartan, compared with olmesartan.
The trial was investigator initiated and received funding from Novartis. Dr. Schmieder has received honoraria from Novartis and also from AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, and Servier.
[email protected]
On Twitter @mitchelzoler
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point: .
Major finding: After 1 year, average left ventricular mass index fell 6.8 g/m2 from baseline with sacubitril/valsartan and 3.5 g/m2 with olmesartan.
Data source: A multicenter, randomized trial with 114 patients with mild or moderate hypertension.
Disclosures: The trial was investigator initiated and received funding from Novartis, the company that markets sacubitril plus valsartan (Entresto). Dr. Schmieder has received honoraria from Novartis and also from AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, and Servier.
FDA bans powdered gloves
The Food and Drug Administration has banned powdered gloves for use in health care settings, citing “numerous risks to patients and health care workers.” The ban extends to gloves currently in commercial distribution and in the hands of the ultimate user, meaning powdered gloves will have to be pulled from examination rooms and operating theaters.
“A thorough review of all currently available information supports FDA’s conclusion that powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove should be banned,” according to a FDA final rule available now online and scheduled for publication in the Federal Register on Dec. 19, 2016. The ban will become effective 30 days after the document’s publication in the Federal Register.
Notes the final document, “The benefits of powdered gloves appear to only include greater ease of donning and doffing, decreased tackiness, and a degree of added comfort, which FDA believes are nominal when compared to the risks posed by these devices.”
Since viable nonpowdered alternatives exist, the FDA believes that the ban would not have significant economic impact and that shortages should not affect care delivery.
Many nonpowdered gloves, said the FDA, now “have the same level of protection, dexterity, and performance” as powdered gloves.
Powder may still be used in the glove manufacturing process, but the FDA continues to recommend that no more than 2 mg of residual powder per glove remains after the manufacturing process.
Though the final document banning powdered gloves notes that the FDA received many comments asking for a ban of all natural rubber latex (NRL) gloves, the ban applied only to powdered gloves. The FDA noted that NRL gloves already must carry a statement alerting users to the risks of allergic reaction, and also noted that eliminating powder from NRL gloves reduces the risk of latex sensitization.
In explaining its analysis of the costs and benefits of the powdered glove ban, the FDA estimated that the annual net benefits would range between $26.8 million and $31.8 million.
When this ban comes into force, it will be only the second such ban; the first was the 1983 ban of prosthetic hair fibers, which were found to provide no public health benefit.
[email protected]
On Twitter @karioakes
The Food and Drug Administration has banned powdered gloves for use in health care settings, citing “numerous risks to patients and health care workers.” The ban extends to gloves currently in commercial distribution and in the hands of the ultimate user, meaning powdered gloves will have to be pulled from examination rooms and operating theaters.
“A thorough review of all currently available information supports FDA’s conclusion that powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove should be banned,” according to a FDA final rule available now online and scheduled for publication in the Federal Register on Dec. 19, 2016. The ban will become effective 30 days after the document’s publication in the Federal Register.
Notes the final document, “The benefits of powdered gloves appear to only include greater ease of donning and doffing, decreased tackiness, and a degree of added comfort, which FDA believes are nominal when compared to the risks posed by these devices.”
Since viable nonpowdered alternatives exist, the FDA believes that the ban would not have significant economic impact and that shortages should not affect care delivery.
Many nonpowdered gloves, said the FDA, now “have the same level of protection, dexterity, and performance” as powdered gloves.
Powder may still be used in the glove manufacturing process, but the FDA continues to recommend that no more than 2 mg of residual powder per glove remains after the manufacturing process.
Though the final document banning powdered gloves notes that the FDA received many comments asking for a ban of all natural rubber latex (NRL) gloves, the ban applied only to powdered gloves. The FDA noted that NRL gloves already must carry a statement alerting users to the risks of allergic reaction, and also noted that eliminating powder from NRL gloves reduces the risk of latex sensitization.
In explaining its analysis of the costs and benefits of the powdered glove ban, the FDA estimated that the annual net benefits would range between $26.8 million and $31.8 million.
When this ban comes into force, it will be only the second such ban; the first was the 1983 ban of prosthetic hair fibers, which were found to provide no public health benefit.
[email protected]
On Twitter @karioakes
The Food and Drug Administration has banned powdered gloves for use in health care settings, citing “numerous risks to patients and health care workers.” The ban extends to gloves currently in commercial distribution and in the hands of the ultimate user, meaning powdered gloves will have to be pulled from examination rooms and operating theaters.
“A thorough review of all currently available information supports FDA’s conclusion that powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove should be banned,” according to a FDA final rule available now online and scheduled for publication in the Federal Register on Dec. 19, 2016. The ban will become effective 30 days after the document’s publication in the Federal Register.
Notes the final document, “The benefits of powdered gloves appear to only include greater ease of donning and doffing, decreased tackiness, and a degree of added comfort, which FDA believes are nominal when compared to the risks posed by these devices.”
Since viable nonpowdered alternatives exist, the FDA believes that the ban would not have significant economic impact and that shortages should not affect care delivery.
Many nonpowdered gloves, said the FDA, now “have the same level of protection, dexterity, and performance” as powdered gloves.
Powder may still be used in the glove manufacturing process, but the FDA continues to recommend that no more than 2 mg of residual powder per glove remains after the manufacturing process.
Though the final document banning powdered gloves notes that the FDA received many comments asking for a ban of all natural rubber latex (NRL) gloves, the ban applied only to powdered gloves. The FDA noted that NRL gloves already must carry a statement alerting users to the risks of allergic reaction, and also noted that eliminating powder from NRL gloves reduces the risk of latex sensitization.
In explaining its analysis of the costs and benefits of the powdered glove ban, the FDA estimated that the annual net benefits would range between $26.8 million and $31.8 million.
When this ban comes into force, it will be only the second such ban; the first was the 1983 ban of prosthetic hair fibers, which were found to provide no public health benefit.
[email protected]
On Twitter @karioakes
FDA warning: General anesthetics may damage young brains
The Food and Drug Administration has issued a warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.
“Recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning.” The studies suggesting a problem with longer or repeat exposures “had limitations, and it is unclear whether any negative effects seen in children’s learning or behavior were due to the drugs or to other factors, such as the underlying medical condition that led to the need for the surgery or procedure.” Further research is needed, the agency said.
FDA is adding its warning to the labels of 11 general anesthetics and sedatives, including desflurane, halothane, ketamine, lorazepam injection, methohexital, pentobarbital, and propofol. The drugs block N-methyl-D-aspartate (NMDA) receptors and/or potentiate gamma-aminobutyric acid (GABA) activity. No specific medications have been shown to be safer than any other, the agency said.
FDA will continue to monitor the situation, and update its warning as additional information comes in. “We urge health care professionals, patients, parents, and caregivers to report side effects involving anesthetic and sedation drugs or other medicines to the FDA MedWatch program,” the FDA said.
The Food and Drug Administration has issued a warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.
“Recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning.” The studies suggesting a problem with longer or repeat exposures “had limitations, and it is unclear whether any negative effects seen in children’s learning or behavior were due to the drugs or to other factors, such as the underlying medical condition that led to the need for the surgery or procedure.” Further research is needed, the agency said.
FDA is adding its warning to the labels of 11 general anesthetics and sedatives, including desflurane, halothane, ketamine, lorazepam injection, methohexital, pentobarbital, and propofol. The drugs block N-methyl-D-aspartate (NMDA) receptors and/or potentiate gamma-aminobutyric acid (GABA) activity. No specific medications have been shown to be safer than any other, the agency said.
FDA will continue to monitor the situation, and update its warning as additional information comes in. “We urge health care professionals, patients, parents, and caregivers to report side effects involving anesthetic and sedation drugs or other medicines to the FDA MedWatch program,” the FDA said.
The Food and Drug Administration has issued a warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.
“Recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning.” The studies suggesting a problem with longer or repeat exposures “had limitations, and it is unclear whether any negative effects seen in children’s learning or behavior were due to the drugs or to other factors, such as the underlying medical condition that led to the need for the surgery or procedure.” Further research is needed, the agency said.
FDA is adding its warning to the labels of 11 general anesthetics and sedatives, including desflurane, halothane, ketamine, lorazepam injection, methohexital, pentobarbital, and propofol. The drugs block N-methyl-D-aspartate (NMDA) receptors and/or potentiate gamma-aminobutyric acid (GABA) activity. No specific medications have been shown to be safer than any other, the agency said.
FDA will continue to monitor the situation, and update its warning as additional information comes in. “We urge health care professionals, patients, parents, and caregivers to report side effects involving anesthetic and sedation drugs or other medicines to the FDA MedWatch program,” the FDA said.