User login
Clinical Guidelines Hub only
Guideline: Prioritize nondrug therapies for low back pain
Clinicians and patients should prioritize nonpharmacologic therapies for low back pain of any duration, according to an updated guideline from the American College of Physicians.
For acute and subacute low back pain, first-line choices include heat, massage, acupuncture, and spinal manipulation, Amir Qaseem, MD, PhD, and his associates wrote in the Annals of Internal Medicine. Patients with chronic low back pain have many nondrug options, ranging from exercise and tai chi to mindfulness-based stress reduction and spinal manipulation, the authors add (Ann Intern Med. 2017 Feb 14. doi: 10.7326/M16-2367).
The updated therapeutic recommendations focus on clinical presentations. They define acute low back pain as lasting less than 4 weeks, subacute low back pain as lasting 4-12 weeks, and chronic low back pain as lasting more than 12 weeks. For acute and subacute low back pain, low to moderate quality evidence supports the efficacy of acupuncture, massage, spinal manipulation, superficial heat, lumbar supports, and low-level laser therapy, the guideline authors conclude.
They recommend considering nonsteroidal anti-inflammatory drugs or skeletal muscle relaxants for patients who want medications for acute or subacute low back pain. There is moderate-quality evidence that NSAIDs confer a small analgesic benefit, compared with placebo, but their renal and gastrointestinal risks call for careful patient selection and use of the lowest possible doses and treatment durations, the authors emphasized.
Likewise, moderate-quality evidence supports the use of skeletal muscle relaxants for short-term pain relief, but patients should know that these drugs can lead to sedation and other adverse effects on the central nervous system, they stated.
Acetaminophen is no longer recommended for low back pain, having failed to shorten time to recovery, compared with placebo, in a large, multicenter, randomized trial (Lancet. 2014 Nov 1;384[9954]:1586-96).
Likewise, short-term oral or intramuscular corticosteroids have been found ineffective for acute low back pain, while benzodiazepines are ineffective for radiculopathy, the experts noted.
“Evidence was insufficient to determine effectiveness of antidepressants, benzodiazepines, antiseizure medications, or opioids, versus placebo, in patients with acute or subacute low back pain,” they added.
The guideline authors also noted insufficient evidence for many nondrug therapies for acute and subacute low back pain, including transcutaneous electrical nerve stimulation, electrical muscle stimulation, inferential therapy, short-wave diathermy, traction, superficial cold, motor control exercise, Pilates, tai chi, yoga, psychological therapies, multidisciplinary rehabilitation, ultrasound, and taping.
For chronic low back pain, the guideline strongly recommends starting with nondrug therapies, including exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction, tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation.
Despite low-quality evidence for these modalities, “fewer harms are associated with these types of therapies than with pharmacologic options,” the authors wrote.
If nonpharmacologic interventions fail to improve chronic low back pain, the experts recommended NSAIDs in the first line, followed by second-line therapy with tramadol or duloxetine (Cymbalta). Recent evidence suggests that NSAIDs are less effective for low back pain than previously thought, while the trials that reported a modest analgesic benefit of duloxetine over placebo were industry funded, the authors note.
Opioids should only be considered for chronic low back pain that fails both nondrug and nonopioid therapies, “and only if the potential benefits outweigh the risks for individual patients, and after a discussion of known risks and realistic benefits,” the guideline authors emphasized.
This update does not cover topical therapies or epidural injections. Epidural steroid injections decreased pain associated with radiculopathy in the short term but did not confer long-term benefits, according to a recent separate review (Ann Intern Med. 2015 Sep 1;163[5]:373-81).
The Agency for Healthcare Research and Quality funded the work. One coauthor disclosed personal fees from Takeda Pharmaceuticals outside the submitted work, and membership in the American College of Physicians Clinical Guidelines Committee and the American College of Rheumatology Quality of Care Committee. The other authors had no conflicts. Two members of the ACP Clinical Guidelines Committee disclosed ties to Healthwise and UpToDate outside the submitted work.
Despite the considerable effort invested in these systematic reviews and in providing clinicians with rational recommendations for care, doubts exist as to whether simply publishing this work will be sufficient to drive guideline-concordant care.
Systematic reviews and recommendations from governmental organizations and professional societies are not new and predate large increases in diagnostic and therapeutic services.
For example, the lack of evidence supporting opiates for low back pain did not prevent their dramatic increase in use. Moreover, these updated reviews and recommendations do not focus on diagnostic tests, such as magnetic resonance imaging, and invasive therapies, such as injections and surgery, which are major drivers of health care spending for low back pain.
If clinicians and their professional societies cannot demonstrate that their recommendations are improving the delivery of high-value services, what are the alternatives?
Likely what is needed is an “all of the above” approach: more pragmatic trials to evaluate proven therapies and their combinations in real-world settings; efforts to reduce the use of low-value services, such as payer coverage policies based on guideline recommendations; patient engagement through shared decision making; and pressure on insurers to cover nonpharmacologic, noninvasive therapies that have shown benefit.
Steven J. Atlas, MD, MPH, is at Massachusetts General Hospital in Boston. He disclosed royalties from UpToDate and personal fees from Healthwise. These comments are from his editorial (Ann Intern Med. 2017 Feb 14. doi: 10.7326/M17-0923).
Despite the considerable effort invested in these systematic reviews and in providing clinicians with rational recommendations for care, doubts exist as to whether simply publishing this work will be sufficient to drive guideline-concordant care.
Systematic reviews and recommendations from governmental organizations and professional societies are not new and predate large increases in diagnostic and therapeutic services.
For example, the lack of evidence supporting opiates for low back pain did not prevent their dramatic increase in use. Moreover, these updated reviews and recommendations do not focus on diagnostic tests, such as magnetic resonance imaging, and invasive therapies, such as injections and surgery, which are major drivers of health care spending for low back pain.
If clinicians and their professional societies cannot demonstrate that their recommendations are improving the delivery of high-value services, what are the alternatives?
Likely what is needed is an “all of the above” approach: more pragmatic trials to evaluate proven therapies and their combinations in real-world settings; efforts to reduce the use of low-value services, such as payer coverage policies based on guideline recommendations; patient engagement through shared decision making; and pressure on insurers to cover nonpharmacologic, noninvasive therapies that have shown benefit.
Steven J. Atlas, MD, MPH, is at Massachusetts General Hospital in Boston. He disclosed royalties from UpToDate and personal fees from Healthwise. These comments are from his editorial (Ann Intern Med. 2017 Feb 14. doi: 10.7326/M17-0923).
Despite the considerable effort invested in these systematic reviews and in providing clinicians with rational recommendations for care, doubts exist as to whether simply publishing this work will be sufficient to drive guideline-concordant care.
Systematic reviews and recommendations from governmental organizations and professional societies are not new and predate large increases in diagnostic and therapeutic services.
For example, the lack of evidence supporting opiates for low back pain did not prevent their dramatic increase in use. Moreover, these updated reviews and recommendations do not focus on diagnostic tests, such as magnetic resonance imaging, and invasive therapies, such as injections and surgery, which are major drivers of health care spending for low back pain.
If clinicians and their professional societies cannot demonstrate that their recommendations are improving the delivery of high-value services, what are the alternatives?
Likely what is needed is an “all of the above” approach: more pragmatic trials to evaluate proven therapies and their combinations in real-world settings; efforts to reduce the use of low-value services, such as payer coverage policies based on guideline recommendations; patient engagement through shared decision making; and pressure on insurers to cover nonpharmacologic, noninvasive therapies that have shown benefit.
Steven J. Atlas, MD, MPH, is at Massachusetts General Hospital in Boston. He disclosed royalties from UpToDate and personal fees from Healthwise. These comments are from his editorial (Ann Intern Med. 2017 Feb 14. doi: 10.7326/M17-0923).
Clinicians and patients should prioritize nonpharmacologic therapies for low back pain of any duration, according to an updated guideline from the American College of Physicians.
For acute and subacute low back pain, first-line choices include heat, massage, acupuncture, and spinal manipulation, Amir Qaseem, MD, PhD, and his associates wrote in the Annals of Internal Medicine. Patients with chronic low back pain have many nondrug options, ranging from exercise and tai chi to mindfulness-based stress reduction and spinal manipulation, the authors add (Ann Intern Med. 2017 Feb 14. doi: 10.7326/M16-2367).
The updated therapeutic recommendations focus on clinical presentations. They define acute low back pain as lasting less than 4 weeks, subacute low back pain as lasting 4-12 weeks, and chronic low back pain as lasting more than 12 weeks. For acute and subacute low back pain, low to moderate quality evidence supports the efficacy of acupuncture, massage, spinal manipulation, superficial heat, lumbar supports, and low-level laser therapy, the guideline authors conclude.
They recommend considering nonsteroidal anti-inflammatory drugs or skeletal muscle relaxants for patients who want medications for acute or subacute low back pain. There is moderate-quality evidence that NSAIDs confer a small analgesic benefit, compared with placebo, but their renal and gastrointestinal risks call for careful patient selection and use of the lowest possible doses and treatment durations, the authors emphasized.
Likewise, moderate-quality evidence supports the use of skeletal muscle relaxants for short-term pain relief, but patients should know that these drugs can lead to sedation and other adverse effects on the central nervous system, they stated.
Acetaminophen is no longer recommended for low back pain, having failed to shorten time to recovery, compared with placebo, in a large, multicenter, randomized trial (Lancet. 2014 Nov 1;384[9954]:1586-96).
Likewise, short-term oral or intramuscular corticosteroids have been found ineffective for acute low back pain, while benzodiazepines are ineffective for radiculopathy, the experts noted.
“Evidence was insufficient to determine effectiveness of antidepressants, benzodiazepines, antiseizure medications, or opioids, versus placebo, in patients with acute or subacute low back pain,” they added.
The guideline authors also noted insufficient evidence for many nondrug therapies for acute and subacute low back pain, including transcutaneous electrical nerve stimulation, electrical muscle stimulation, inferential therapy, short-wave diathermy, traction, superficial cold, motor control exercise, Pilates, tai chi, yoga, psychological therapies, multidisciplinary rehabilitation, ultrasound, and taping.
For chronic low back pain, the guideline strongly recommends starting with nondrug therapies, including exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction, tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation.
Despite low-quality evidence for these modalities, “fewer harms are associated with these types of therapies than with pharmacologic options,” the authors wrote.
If nonpharmacologic interventions fail to improve chronic low back pain, the experts recommended NSAIDs in the first line, followed by second-line therapy with tramadol or duloxetine (Cymbalta). Recent evidence suggests that NSAIDs are less effective for low back pain than previously thought, while the trials that reported a modest analgesic benefit of duloxetine over placebo were industry funded, the authors note.
Opioids should only be considered for chronic low back pain that fails both nondrug and nonopioid therapies, “and only if the potential benefits outweigh the risks for individual patients, and after a discussion of known risks and realistic benefits,” the guideline authors emphasized.
This update does not cover topical therapies or epidural injections. Epidural steroid injections decreased pain associated with radiculopathy in the short term but did not confer long-term benefits, according to a recent separate review (Ann Intern Med. 2015 Sep 1;163[5]:373-81).
The Agency for Healthcare Research and Quality funded the work. One coauthor disclosed personal fees from Takeda Pharmaceuticals outside the submitted work, and membership in the American College of Physicians Clinical Guidelines Committee and the American College of Rheumatology Quality of Care Committee. The other authors had no conflicts. Two members of the ACP Clinical Guidelines Committee disclosed ties to Healthwise and UpToDate outside the submitted work.
Clinicians and patients should prioritize nonpharmacologic therapies for low back pain of any duration, according to an updated guideline from the American College of Physicians.
For acute and subacute low back pain, first-line choices include heat, massage, acupuncture, and spinal manipulation, Amir Qaseem, MD, PhD, and his associates wrote in the Annals of Internal Medicine. Patients with chronic low back pain have many nondrug options, ranging from exercise and tai chi to mindfulness-based stress reduction and spinal manipulation, the authors add (Ann Intern Med. 2017 Feb 14. doi: 10.7326/M16-2367).
The updated therapeutic recommendations focus on clinical presentations. They define acute low back pain as lasting less than 4 weeks, subacute low back pain as lasting 4-12 weeks, and chronic low back pain as lasting more than 12 weeks. For acute and subacute low back pain, low to moderate quality evidence supports the efficacy of acupuncture, massage, spinal manipulation, superficial heat, lumbar supports, and low-level laser therapy, the guideline authors conclude.
They recommend considering nonsteroidal anti-inflammatory drugs or skeletal muscle relaxants for patients who want medications for acute or subacute low back pain. There is moderate-quality evidence that NSAIDs confer a small analgesic benefit, compared with placebo, but their renal and gastrointestinal risks call for careful patient selection and use of the lowest possible doses and treatment durations, the authors emphasized.
Likewise, moderate-quality evidence supports the use of skeletal muscle relaxants for short-term pain relief, but patients should know that these drugs can lead to sedation and other adverse effects on the central nervous system, they stated.
Acetaminophen is no longer recommended for low back pain, having failed to shorten time to recovery, compared with placebo, in a large, multicenter, randomized trial (Lancet. 2014 Nov 1;384[9954]:1586-96).
Likewise, short-term oral or intramuscular corticosteroids have been found ineffective for acute low back pain, while benzodiazepines are ineffective for radiculopathy, the experts noted.
“Evidence was insufficient to determine effectiveness of antidepressants, benzodiazepines, antiseizure medications, or opioids, versus placebo, in patients with acute or subacute low back pain,” they added.
The guideline authors also noted insufficient evidence for many nondrug therapies for acute and subacute low back pain, including transcutaneous electrical nerve stimulation, electrical muscle stimulation, inferential therapy, short-wave diathermy, traction, superficial cold, motor control exercise, Pilates, tai chi, yoga, psychological therapies, multidisciplinary rehabilitation, ultrasound, and taping.
For chronic low back pain, the guideline strongly recommends starting with nondrug therapies, including exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction, tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation.
Despite low-quality evidence for these modalities, “fewer harms are associated with these types of therapies than with pharmacologic options,” the authors wrote.
If nonpharmacologic interventions fail to improve chronic low back pain, the experts recommended NSAIDs in the first line, followed by second-line therapy with tramadol or duloxetine (Cymbalta). Recent evidence suggests that NSAIDs are less effective for low back pain than previously thought, while the trials that reported a modest analgesic benefit of duloxetine over placebo were industry funded, the authors note.
Opioids should only be considered for chronic low back pain that fails both nondrug and nonopioid therapies, “and only if the potential benefits outweigh the risks for individual patients, and after a discussion of known risks and realistic benefits,” the guideline authors emphasized.
This update does not cover topical therapies or epidural injections. Epidural steroid injections decreased pain associated with radiculopathy in the short term but did not confer long-term benefits, according to a recent separate review (Ann Intern Med. 2015 Sep 1;163[5]:373-81).
The Agency for Healthcare Research and Quality funded the work. One coauthor disclosed personal fees from Takeda Pharmaceuticals outside the submitted work, and membership in the American College of Physicians Clinical Guidelines Committee and the American College of Rheumatology Quality of Care Committee. The other authors had no conflicts. Two members of the ACP Clinical Guidelines Committee disclosed ties to Healthwise and UpToDate outside the submitted work.
FROM ANNALS OF INTERNAL MEDICINE
Complex congenital heart conditions call for complex care in pregnancy
A new scientific statement from the American Heart Association (AHA) brings together recommendations for management of pregnancy for women with serious congenital heart disease. The 38-page document addresses a wide range of complex congenital heart conditions, presenting a newly unified set of recommendations for care that ranges from preconception counseling, through pregnancy, labor, and delivery, to the postpartum period.
Caring for women with complex congenital heart lesions is becoming more commonplace, as more infants undergo successful repairs of previously-unsurvivable cardiac anomalies. “More moms with congenital heart disease are showing up pregnant, having survived the tumultuous peripartum and neonatal period, and are now facing a new set of risks in pregnancy,” Michael Foley, MD, chair of the department of obstetrics and gynecology at the University of Arizona, Phoenix, said in an interview.
Joseph Kay, MD, a cardiologist and professor of medicine and pediatrics at the University of Colorado, Aurora, said that one big benefit of the new scientific statement is having a single reference point for care of these patients. “The scientific statement brings all of the information about caring for these patients together into one document. This will be a very valuable resource for trainees to get a sense of what’s important; it also represents a platform for new programs to understand the scope of services needed,” said Dr. Kay in an interview.
The document provides a thorough review of the physiologic changes of pregnancy and the intrapartum and postpartum periods, noting that the heterogeneity of congenital heart disease means that women who have different lesions carry different risks in pregnancy.
Examples of lesions presenting intermediate risk include most arrhythmias (category II), hypertrophic cardiomyopathy, and a repaired coarctation (both category II-III). The most severe lesions carry a contraindication for pregnancy; the WHO guidelines suggest discussing termination should women with a category IV lesion become pregnant. Severe mitral stenosis, severe symptomatic aortic stenosis, and severe systemic ventricular dysfunction all place women into category IV.
Beginning with pregnancy risk category III, the WHO guidelines recommend intensive cardiac and obstetric monitoring throughout pregnancy, childbirth, and the puerperium. Several maternal-fetal medicine specialists interviewed all agreed that an interdisciplinary team is a must for good obstetric care in this population.
How interdisciplinary care plays out can depend on geography and facility-dependent resources. Dr. Kay said that his facility is the referral site for pregnant women with complex congenital lesions in an area that spans the Canadian and the Mexican borders from north to south, and ranges from parts of Kansas to eastern Montana from east to west. Still, Dr. Kay said that even for patients with lower-risk lesions, “We will see patients at least once, at approximately the midpoint of pregnancy, and again during the third trimester if possible.” The specifics of care depend on “the nature of the lesion and the complexity of the disease,” said Dr. Kay.
In his facility, said Dr. Kay, telemetry is available for all of the labor and delivery unit beds. This means that the mother and infant can usually stay together and receive postpartum nursing and lactation care from a skilled staff.
In no circumstances should ob.gyns. go it alone, said Dr. Foley. “The conversation with the ob.gyn. needs to be about comanaging these patients, at the very least. Even the most learned maternal-fetal medicine specialist needs to be working with a cardiologist and an anesthesiologist to create a delivery plan that includes pain management, fluid management, and consideration for intrapartum hemodynamic monitoring,” he said.
And the team needs to be in place long before delivery, Dr. Foley pointed out. “In many hospitals, the care delivery gap may be the inability to have this consistent proactive approach. You can’t expect the best outcomes when you have to hurriedly assemble an unfamiliar ad hoc team when a woman with congenital heart disease presents in labor. Despite their best intentions, inconsistent team members may not have the knowledge and experience to provide the safest care for these patients,” he said.
Though an individualized labor and delivery plan is a must, and a multispecialty team should be assembled, maternal congenital heart disease doesn’t necessarily consign a woman to cesarean delivery. “Most women can and should have a vaginal delivery. It’s safer for them. If a natural delivery may increase risk of issues, we may consider a facilitated second stage of labor with epidural anesthesia and forceps- or vacuum-assisted delivery,” said Dr. Kay.
It’s important to understand the nuances of an individual patient’s health and risk status, said Dr. Norton. “A simplified view is often bad. It’s not the case that ‘it’s always better to deliver’ or ‘it’s always better to have a cesarean delivery.’”
Especially for women who need anticoagulation or who may have lesions that put them at great risk should pregnancy occur, preconception counseling is a vital part of their care, and guidance in the scientific statement can help specialists avoid the complications that can occur in the absence of evidence-based treatment. Said Dr. Kay, “I have seen an unfortunate case or two of patients whose anticoagulation was stopped or changed, contrary to guidelines, and who suffered strokes. I hope more people will see this document.”
Ms. Canobbio echoed the sentiment: “You don’t want to have to backpedal once a young woman presents with a pregnancy. Appropriate contraceptive counseling needs to be part of the conversation.”
One key concept underscored in the scientific statement is that elevated risk persists into the postpartum period. “Following delivery, the mother is still at risk for an extended period of time. The greatest risk for mortality in these patients is post delivery, when a large volume of blood is expelled from the uterus back into the maternal circulation,” said Ms. Canobbio. “These women need close follow-up; we can’t say they are home free until several weeks to 2 months after delivery. The need for vigilance and surveillance continues.”
Since the scientific statement is not a new set of guidelines, but rather a compilation of currently existing reference documents, the authors noted that management differences may exist in some cases, but did not assign greater value to one practice than another. “We addressed that there are differences between the European and the American guidelines. For example, with regard to anticoagulation, both would agree to use Lovenox [enoxaparin], but the difference is whether it should be used for the entire pregnancy or for parts of the pregnancy,” said Ms. Canobbio.
Looking forward, more women with complex congenital heart disease will bear children, but their future is not certain. Said Ms. Canobbio: “The data are growing that if the patient is clinically stable at the time of pregnancy, it’s likely we can get them through safely. What’s not yet known is whether the burden of pregnancy in a woman who is otherwise healthy will shorten her lifespan. However, early data are promising, and it’s looking like these women can fare well.”
Topics covered in the scientific statement include:
- Defining which patients are at increased risk in pregnancy.
- Physiological adaptations of pregnancy, the puerperium, and the postpartum period, with an emphasis on hemodynamic changes.
- Assessment and evaluation in the preconception and early prenatal periods.
- Pregnancy management, including appropriate testing.
- Medications in pregnancy, including a table of common cardiac drugs and their pregnancy categories and lactation risks.
- Breakdown of suggested prenatal care by trimester.
- Intrapartum care, including indications for fluid management, ECG and hemodynamic monitoring, and management of the second stage of delivery.
- Postpartum care, with attention to the very rapid increase in blood volume and concomitant leap in stroke volume and cardiac output.
- Considerations when choosing contraceptive method.
- Cardiac complications seen in pregnancy, including arrhythmias, managing mechanical valves and anticoagulation, heart failure, and cyanosis.
- Indications for and risks associated with interventional therapies during pregnancy.
- Detailed discussion of management of pregnancy for women with specific lesions.
None of the members of the writing committee for the scientific statement had relevant disclosures. Dr. Foley and Dr. Kay reported no disclosures. Dr. Norton reported that she has received research funding from Natera and Ultragenyx.
koakes@frontlinemedcom.com
On Twitter @karioakes
A new scientific statement from the American Heart Association (AHA) brings together recommendations for management of pregnancy for women with serious congenital heart disease. The 38-page document addresses a wide range of complex congenital heart conditions, presenting a newly unified set of recommendations for care that ranges from preconception counseling, through pregnancy, labor, and delivery, to the postpartum period.
Caring for women with complex congenital heart lesions is becoming more commonplace, as more infants undergo successful repairs of previously-unsurvivable cardiac anomalies. “More moms with congenital heart disease are showing up pregnant, having survived the tumultuous peripartum and neonatal period, and are now facing a new set of risks in pregnancy,” Michael Foley, MD, chair of the department of obstetrics and gynecology at the University of Arizona, Phoenix, said in an interview.
Joseph Kay, MD, a cardiologist and professor of medicine and pediatrics at the University of Colorado, Aurora, said that one big benefit of the new scientific statement is having a single reference point for care of these patients. “The scientific statement brings all of the information about caring for these patients together into one document. This will be a very valuable resource for trainees to get a sense of what’s important; it also represents a platform for new programs to understand the scope of services needed,” said Dr. Kay in an interview.
The document provides a thorough review of the physiologic changes of pregnancy and the intrapartum and postpartum periods, noting that the heterogeneity of congenital heart disease means that women who have different lesions carry different risks in pregnancy.
Examples of lesions presenting intermediate risk include most arrhythmias (category II), hypertrophic cardiomyopathy, and a repaired coarctation (both category II-III). The most severe lesions carry a contraindication for pregnancy; the WHO guidelines suggest discussing termination should women with a category IV lesion become pregnant. Severe mitral stenosis, severe symptomatic aortic stenosis, and severe systemic ventricular dysfunction all place women into category IV.
Beginning with pregnancy risk category III, the WHO guidelines recommend intensive cardiac and obstetric monitoring throughout pregnancy, childbirth, and the puerperium. Several maternal-fetal medicine specialists interviewed all agreed that an interdisciplinary team is a must for good obstetric care in this population.
How interdisciplinary care plays out can depend on geography and facility-dependent resources. Dr. Kay said that his facility is the referral site for pregnant women with complex congenital lesions in an area that spans the Canadian and the Mexican borders from north to south, and ranges from parts of Kansas to eastern Montana from east to west. Still, Dr. Kay said that even for patients with lower-risk lesions, “We will see patients at least once, at approximately the midpoint of pregnancy, and again during the third trimester if possible.” The specifics of care depend on “the nature of the lesion and the complexity of the disease,” said Dr. Kay.
In his facility, said Dr. Kay, telemetry is available for all of the labor and delivery unit beds. This means that the mother and infant can usually stay together and receive postpartum nursing and lactation care from a skilled staff.
In no circumstances should ob.gyns. go it alone, said Dr. Foley. “The conversation with the ob.gyn. needs to be about comanaging these patients, at the very least. Even the most learned maternal-fetal medicine specialist needs to be working with a cardiologist and an anesthesiologist to create a delivery plan that includes pain management, fluid management, and consideration for intrapartum hemodynamic monitoring,” he said.
And the team needs to be in place long before delivery, Dr. Foley pointed out. “In many hospitals, the care delivery gap may be the inability to have this consistent proactive approach. You can’t expect the best outcomes when you have to hurriedly assemble an unfamiliar ad hoc team when a woman with congenital heart disease presents in labor. Despite their best intentions, inconsistent team members may not have the knowledge and experience to provide the safest care for these patients,” he said.
Though an individualized labor and delivery plan is a must, and a multispecialty team should be assembled, maternal congenital heart disease doesn’t necessarily consign a woman to cesarean delivery. “Most women can and should have a vaginal delivery. It’s safer for them. If a natural delivery may increase risk of issues, we may consider a facilitated second stage of labor with epidural anesthesia and forceps- or vacuum-assisted delivery,” said Dr. Kay.
It’s important to understand the nuances of an individual patient’s health and risk status, said Dr. Norton. “A simplified view is often bad. It’s not the case that ‘it’s always better to deliver’ or ‘it’s always better to have a cesarean delivery.’”
Especially for women who need anticoagulation or who may have lesions that put them at great risk should pregnancy occur, preconception counseling is a vital part of their care, and guidance in the scientific statement can help specialists avoid the complications that can occur in the absence of evidence-based treatment. Said Dr. Kay, “I have seen an unfortunate case or two of patients whose anticoagulation was stopped or changed, contrary to guidelines, and who suffered strokes. I hope more people will see this document.”
Ms. Canobbio echoed the sentiment: “You don’t want to have to backpedal once a young woman presents with a pregnancy. Appropriate contraceptive counseling needs to be part of the conversation.”
One key concept underscored in the scientific statement is that elevated risk persists into the postpartum period. “Following delivery, the mother is still at risk for an extended period of time. The greatest risk for mortality in these patients is post delivery, when a large volume of blood is expelled from the uterus back into the maternal circulation,” said Ms. Canobbio. “These women need close follow-up; we can’t say they are home free until several weeks to 2 months after delivery. The need for vigilance and surveillance continues.”
Since the scientific statement is not a new set of guidelines, but rather a compilation of currently existing reference documents, the authors noted that management differences may exist in some cases, but did not assign greater value to one practice than another. “We addressed that there are differences between the European and the American guidelines. For example, with regard to anticoagulation, both would agree to use Lovenox [enoxaparin], but the difference is whether it should be used for the entire pregnancy or for parts of the pregnancy,” said Ms. Canobbio.
Looking forward, more women with complex congenital heart disease will bear children, but their future is not certain. Said Ms. Canobbio: “The data are growing that if the patient is clinically stable at the time of pregnancy, it’s likely we can get them through safely. What’s not yet known is whether the burden of pregnancy in a woman who is otherwise healthy will shorten her lifespan. However, early data are promising, and it’s looking like these women can fare well.”
Topics covered in the scientific statement include:
- Defining which patients are at increased risk in pregnancy.
- Physiological adaptations of pregnancy, the puerperium, and the postpartum period, with an emphasis on hemodynamic changes.
- Assessment and evaluation in the preconception and early prenatal periods.
- Pregnancy management, including appropriate testing.
- Medications in pregnancy, including a table of common cardiac drugs and their pregnancy categories and lactation risks.
- Breakdown of suggested prenatal care by trimester.
- Intrapartum care, including indications for fluid management, ECG and hemodynamic monitoring, and management of the second stage of delivery.
- Postpartum care, with attention to the very rapid increase in blood volume and concomitant leap in stroke volume and cardiac output.
- Considerations when choosing contraceptive method.
- Cardiac complications seen in pregnancy, including arrhythmias, managing mechanical valves and anticoagulation, heart failure, and cyanosis.
- Indications for and risks associated with interventional therapies during pregnancy.
- Detailed discussion of management of pregnancy for women with specific lesions.
None of the members of the writing committee for the scientific statement had relevant disclosures. Dr. Foley and Dr. Kay reported no disclosures. Dr. Norton reported that she has received research funding from Natera and Ultragenyx.
koakes@frontlinemedcom.com
On Twitter @karioakes
A new scientific statement from the American Heart Association (AHA) brings together recommendations for management of pregnancy for women with serious congenital heart disease. The 38-page document addresses a wide range of complex congenital heart conditions, presenting a newly unified set of recommendations for care that ranges from preconception counseling, through pregnancy, labor, and delivery, to the postpartum period.
Caring for women with complex congenital heart lesions is becoming more commonplace, as more infants undergo successful repairs of previously-unsurvivable cardiac anomalies. “More moms with congenital heart disease are showing up pregnant, having survived the tumultuous peripartum and neonatal period, and are now facing a new set of risks in pregnancy,” Michael Foley, MD, chair of the department of obstetrics and gynecology at the University of Arizona, Phoenix, said in an interview.
Joseph Kay, MD, a cardiologist and professor of medicine and pediatrics at the University of Colorado, Aurora, said that one big benefit of the new scientific statement is having a single reference point for care of these patients. “The scientific statement brings all of the information about caring for these patients together into one document. This will be a very valuable resource for trainees to get a sense of what’s important; it also represents a platform for new programs to understand the scope of services needed,” said Dr. Kay in an interview.
The document provides a thorough review of the physiologic changes of pregnancy and the intrapartum and postpartum periods, noting that the heterogeneity of congenital heart disease means that women who have different lesions carry different risks in pregnancy.
Examples of lesions presenting intermediate risk include most arrhythmias (category II), hypertrophic cardiomyopathy, and a repaired coarctation (both category II-III). The most severe lesions carry a contraindication for pregnancy; the WHO guidelines suggest discussing termination should women with a category IV lesion become pregnant. Severe mitral stenosis, severe symptomatic aortic stenosis, and severe systemic ventricular dysfunction all place women into category IV.
Beginning with pregnancy risk category III, the WHO guidelines recommend intensive cardiac and obstetric monitoring throughout pregnancy, childbirth, and the puerperium. Several maternal-fetal medicine specialists interviewed all agreed that an interdisciplinary team is a must for good obstetric care in this population.
How interdisciplinary care plays out can depend on geography and facility-dependent resources. Dr. Kay said that his facility is the referral site for pregnant women with complex congenital lesions in an area that spans the Canadian and the Mexican borders from north to south, and ranges from parts of Kansas to eastern Montana from east to west. Still, Dr. Kay said that even for patients with lower-risk lesions, “We will see patients at least once, at approximately the midpoint of pregnancy, and again during the third trimester if possible.” The specifics of care depend on “the nature of the lesion and the complexity of the disease,” said Dr. Kay.
In his facility, said Dr. Kay, telemetry is available for all of the labor and delivery unit beds. This means that the mother and infant can usually stay together and receive postpartum nursing and lactation care from a skilled staff.
In no circumstances should ob.gyns. go it alone, said Dr. Foley. “The conversation with the ob.gyn. needs to be about comanaging these patients, at the very least. Even the most learned maternal-fetal medicine specialist needs to be working with a cardiologist and an anesthesiologist to create a delivery plan that includes pain management, fluid management, and consideration for intrapartum hemodynamic monitoring,” he said.
And the team needs to be in place long before delivery, Dr. Foley pointed out. “In many hospitals, the care delivery gap may be the inability to have this consistent proactive approach. You can’t expect the best outcomes when you have to hurriedly assemble an unfamiliar ad hoc team when a woman with congenital heart disease presents in labor. Despite their best intentions, inconsistent team members may not have the knowledge and experience to provide the safest care for these patients,” he said.
Though an individualized labor and delivery plan is a must, and a multispecialty team should be assembled, maternal congenital heart disease doesn’t necessarily consign a woman to cesarean delivery. “Most women can and should have a vaginal delivery. It’s safer for them. If a natural delivery may increase risk of issues, we may consider a facilitated second stage of labor with epidural anesthesia and forceps- or vacuum-assisted delivery,” said Dr. Kay.
It’s important to understand the nuances of an individual patient’s health and risk status, said Dr. Norton. “A simplified view is often bad. It’s not the case that ‘it’s always better to deliver’ or ‘it’s always better to have a cesarean delivery.’”
Especially for women who need anticoagulation or who may have lesions that put them at great risk should pregnancy occur, preconception counseling is a vital part of their care, and guidance in the scientific statement can help specialists avoid the complications that can occur in the absence of evidence-based treatment. Said Dr. Kay, “I have seen an unfortunate case or two of patients whose anticoagulation was stopped or changed, contrary to guidelines, and who suffered strokes. I hope more people will see this document.”
Ms. Canobbio echoed the sentiment: “You don’t want to have to backpedal once a young woman presents with a pregnancy. Appropriate contraceptive counseling needs to be part of the conversation.”
One key concept underscored in the scientific statement is that elevated risk persists into the postpartum period. “Following delivery, the mother is still at risk for an extended period of time. The greatest risk for mortality in these patients is post delivery, when a large volume of blood is expelled from the uterus back into the maternal circulation,” said Ms. Canobbio. “These women need close follow-up; we can’t say they are home free until several weeks to 2 months after delivery. The need for vigilance and surveillance continues.”
Since the scientific statement is not a new set of guidelines, but rather a compilation of currently existing reference documents, the authors noted that management differences may exist in some cases, but did not assign greater value to one practice than another. “We addressed that there are differences between the European and the American guidelines. For example, with regard to anticoagulation, both would agree to use Lovenox [enoxaparin], but the difference is whether it should be used for the entire pregnancy or for parts of the pregnancy,” said Ms. Canobbio.
Looking forward, more women with complex congenital heart disease will bear children, but their future is not certain. Said Ms. Canobbio: “The data are growing that if the patient is clinically stable at the time of pregnancy, it’s likely we can get them through safely. What’s not yet known is whether the burden of pregnancy in a woman who is otherwise healthy will shorten her lifespan. However, early data are promising, and it’s looking like these women can fare well.”
Topics covered in the scientific statement include:
- Defining which patients are at increased risk in pregnancy.
- Physiological adaptations of pregnancy, the puerperium, and the postpartum period, with an emphasis on hemodynamic changes.
- Assessment and evaluation in the preconception and early prenatal periods.
- Pregnancy management, including appropriate testing.
- Medications in pregnancy, including a table of common cardiac drugs and their pregnancy categories and lactation risks.
- Breakdown of suggested prenatal care by trimester.
- Intrapartum care, including indications for fluid management, ECG and hemodynamic monitoring, and management of the second stage of delivery.
- Postpartum care, with attention to the very rapid increase in blood volume and concomitant leap in stroke volume and cardiac output.
- Considerations when choosing contraceptive method.
- Cardiac complications seen in pregnancy, including arrhythmias, managing mechanical valves and anticoagulation, heart failure, and cyanosis.
- Indications for and risks associated with interventional therapies during pregnancy.
- Detailed discussion of management of pregnancy for women with specific lesions.
None of the members of the writing committee for the scientific statement had relevant disclosures. Dr. Foley and Dr. Kay reported no disclosures. Dr. Norton reported that she has received research funding from Natera and Ultragenyx.
koakes@frontlinemedcom.com
On Twitter @karioakes
AGA Clinical Practice Update: Treatment for severe alcohol hepatitis challenging
Acute alcoholic hepatitis carries a high risk of mortality, yet only a minority of patients admitted to the hospital with the condition receive appropriate treatment, said the authors of an expert review.
Writing in the January 2017 issue of Clinical Gastroenterology and Hepatology, Mack C. Mitchell Jr., MD, of the University of Texas Southwestern Medical Center, Dallas, and Craig J. McClain, MD, of the University of Louisville (Ky.), described the challenges associated with treating acute alcoholic hepatitis and its consequences.
Acute alcohol hepatitis develops in heavy drinkers and presents with rapid onset of malaise, anorexia, tender hepatomegaly, and features of the systemic inflammatory response syndrome. Patients with alcoholic hepatitis also are at high risk of nutritional deficiency, infection, acute kidney injury, and multiorgan failure.
The two most widely used therapies are glucocorticoids – generally considered the standard of care for severe alcoholic hepatitis – and the phosphodiesterase inhibitor pentoxifylline (Clin Gastroenterol Hepatol. 2017. doi: 10.1016/j.cgh.2016.08.047).
“Although in its most severe form AH has a high short-term mortality rate if untreated, in 2011, only 28% of more than 1,600 patients admitted to U.S. hospitals were treated with glucocorticoids and 17% with pentoxifylline (PTX), suggesting a lack of widespread confidence in the two most frequently used therapies for AH,” the authors wrote.
Both drugs work by addressing the underlying inflammation that plays a key role in liver injury, but the evidence for both is mixed: A 2008 Cochrane systematic review of 15 trials concluded there was no benefit from glucocorticoids, largely because of substantial variability in bias across the trials, while two meta-analyses of pentoxifylline trials concluded that there were no differences in short-term mortality between those who received it and those who did not.
Some patients are unsuitable for glucocorticoids and others may develop resistance. There is also the possibility that, while glucocorticoids may improve short-term survival, the associated increase in infection risk removes that advantage at 90 days and 1 year after diagnosis. These infections, in turn, often precede the development of acute kidney injury and multiorgan failure.
The authors, however, did suggest that the approach of very high, short-term bursts of glucocorticoids to induce “immune paralysis” – an approach taken for lupus nephritis – might be considered.
They stressed that abstinence was the cornerstone of treatment for acute alcoholic hepatitis, with studies showing that patients with alcoholic hepatitis who resume heavy drinking have significantly worse outcomes than those who don’t.
“Although abstinence is important at all stages, it is particularly important to emphasize abstinence beyond 90 days when many patients are regaining normal functioning,” Dr. Mitchell and Dr. McClain wrote.
Infection, kidney injury, and malnutrition are all significant concerns in patients with acute alcoholic hepatitis.
With respect to infection, the authors said considerable suspicion is required to pick up bacterial and fungal infections, as patients may not always have a fever and an elevated white blood cell count is an unreliable indicator. Infection also can lead to acute kidney injury.
Malnutrition is not only common in patients with alcohol hepatitis, but it has a significant negative impact on recovery. All patients should be encouraged to meet nutritional goals as early as possible, but just how to achieve this is controversial, the authors stressed.
For example, one study suggested that enteral nutrition was as good as glucocorticoids in reducing 28-day mortality, while another found enteral nutrition via nasogastric tube – in addition to glucocorticoids – was no better than glucocorticoids alone. “Whether [nasogastric] tubes should be used to provide enteral nutrition is a subject of controversy,” the authors wrote. “Normal- to high-protein diets are safe and do not increase the risk of encephalopathy in patients with AH.”
No conflicts of interest were declared.
Acute alcoholic hepatitis carries a high risk of mortality, yet only a minority of patients admitted to the hospital with the condition receive appropriate treatment, said the authors of an expert review.
Writing in the January 2017 issue of Clinical Gastroenterology and Hepatology, Mack C. Mitchell Jr., MD, of the University of Texas Southwestern Medical Center, Dallas, and Craig J. McClain, MD, of the University of Louisville (Ky.), described the challenges associated with treating acute alcoholic hepatitis and its consequences.
Acute alcohol hepatitis develops in heavy drinkers and presents with rapid onset of malaise, anorexia, tender hepatomegaly, and features of the systemic inflammatory response syndrome. Patients with alcoholic hepatitis also are at high risk of nutritional deficiency, infection, acute kidney injury, and multiorgan failure.
The two most widely used therapies are glucocorticoids – generally considered the standard of care for severe alcoholic hepatitis – and the phosphodiesterase inhibitor pentoxifylline (Clin Gastroenterol Hepatol. 2017. doi: 10.1016/j.cgh.2016.08.047).
“Although in its most severe form AH has a high short-term mortality rate if untreated, in 2011, only 28% of more than 1,600 patients admitted to U.S. hospitals were treated with glucocorticoids and 17% with pentoxifylline (PTX), suggesting a lack of widespread confidence in the two most frequently used therapies for AH,” the authors wrote.
Both drugs work by addressing the underlying inflammation that plays a key role in liver injury, but the evidence for both is mixed: A 2008 Cochrane systematic review of 15 trials concluded there was no benefit from glucocorticoids, largely because of substantial variability in bias across the trials, while two meta-analyses of pentoxifylline trials concluded that there were no differences in short-term mortality between those who received it and those who did not.
Some patients are unsuitable for glucocorticoids and others may develop resistance. There is also the possibility that, while glucocorticoids may improve short-term survival, the associated increase in infection risk removes that advantage at 90 days and 1 year after diagnosis. These infections, in turn, often precede the development of acute kidney injury and multiorgan failure.
The authors, however, did suggest that the approach of very high, short-term bursts of glucocorticoids to induce “immune paralysis” – an approach taken for lupus nephritis – might be considered.
They stressed that abstinence was the cornerstone of treatment for acute alcoholic hepatitis, with studies showing that patients with alcoholic hepatitis who resume heavy drinking have significantly worse outcomes than those who don’t.
“Although abstinence is important at all stages, it is particularly important to emphasize abstinence beyond 90 days when many patients are regaining normal functioning,” Dr. Mitchell and Dr. McClain wrote.
Infection, kidney injury, and malnutrition are all significant concerns in patients with acute alcoholic hepatitis.
With respect to infection, the authors said considerable suspicion is required to pick up bacterial and fungal infections, as patients may not always have a fever and an elevated white blood cell count is an unreliable indicator. Infection also can lead to acute kidney injury.
Malnutrition is not only common in patients with alcohol hepatitis, but it has a significant negative impact on recovery. All patients should be encouraged to meet nutritional goals as early as possible, but just how to achieve this is controversial, the authors stressed.
For example, one study suggested that enteral nutrition was as good as glucocorticoids in reducing 28-day mortality, while another found enteral nutrition via nasogastric tube – in addition to glucocorticoids – was no better than glucocorticoids alone. “Whether [nasogastric] tubes should be used to provide enteral nutrition is a subject of controversy,” the authors wrote. “Normal- to high-protein diets are safe and do not increase the risk of encephalopathy in patients with AH.”
No conflicts of interest were declared.
Acute alcoholic hepatitis carries a high risk of mortality, yet only a minority of patients admitted to the hospital with the condition receive appropriate treatment, said the authors of an expert review.
Writing in the January 2017 issue of Clinical Gastroenterology and Hepatology, Mack C. Mitchell Jr., MD, of the University of Texas Southwestern Medical Center, Dallas, and Craig J. McClain, MD, of the University of Louisville (Ky.), described the challenges associated with treating acute alcoholic hepatitis and its consequences.
Acute alcohol hepatitis develops in heavy drinkers and presents with rapid onset of malaise, anorexia, tender hepatomegaly, and features of the systemic inflammatory response syndrome. Patients with alcoholic hepatitis also are at high risk of nutritional deficiency, infection, acute kidney injury, and multiorgan failure.
The two most widely used therapies are glucocorticoids – generally considered the standard of care for severe alcoholic hepatitis – and the phosphodiesterase inhibitor pentoxifylline (Clin Gastroenterol Hepatol. 2017. doi: 10.1016/j.cgh.2016.08.047).
“Although in its most severe form AH has a high short-term mortality rate if untreated, in 2011, only 28% of more than 1,600 patients admitted to U.S. hospitals were treated with glucocorticoids and 17% with pentoxifylline (PTX), suggesting a lack of widespread confidence in the two most frequently used therapies for AH,” the authors wrote.
Both drugs work by addressing the underlying inflammation that plays a key role in liver injury, but the evidence for both is mixed: A 2008 Cochrane systematic review of 15 trials concluded there was no benefit from glucocorticoids, largely because of substantial variability in bias across the trials, while two meta-analyses of pentoxifylline trials concluded that there were no differences in short-term mortality between those who received it and those who did not.
Some patients are unsuitable for glucocorticoids and others may develop resistance. There is also the possibility that, while glucocorticoids may improve short-term survival, the associated increase in infection risk removes that advantage at 90 days and 1 year after diagnosis. These infections, in turn, often precede the development of acute kidney injury and multiorgan failure.
The authors, however, did suggest that the approach of very high, short-term bursts of glucocorticoids to induce “immune paralysis” – an approach taken for lupus nephritis – might be considered.
They stressed that abstinence was the cornerstone of treatment for acute alcoholic hepatitis, with studies showing that patients with alcoholic hepatitis who resume heavy drinking have significantly worse outcomes than those who don’t.
“Although abstinence is important at all stages, it is particularly important to emphasize abstinence beyond 90 days when many patients are regaining normal functioning,” Dr. Mitchell and Dr. McClain wrote.
Infection, kidney injury, and malnutrition are all significant concerns in patients with acute alcoholic hepatitis.
With respect to infection, the authors said considerable suspicion is required to pick up bacterial and fungal infections, as patients may not always have a fever and an elevated white blood cell count is an unreliable indicator. Infection also can lead to acute kidney injury.
Malnutrition is not only common in patients with alcohol hepatitis, but it has a significant negative impact on recovery. All patients should be encouraged to meet nutritional goals as early as possible, but just how to achieve this is controversial, the authors stressed.
For example, one study suggested that enteral nutrition was as good as glucocorticoids in reducing 28-day mortality, while another found enteral nutrition via nasogastric tube – in addition to glucocorticoids – was no better than glucocorticoids alone. “Whether [nasogastric] tubes should be used to provide enteral nutrition is a subject of controversy,” the authors wrote. “Normal- to high-protein diets are safe and do not increase the risk of encephalopathy in patients with AH.”
No conflicts of interest were declared.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
ADA: Empagliflozin and liraglutide reduce type 2 CV death
to reduce the risk of CV death, according to the American Diabetes Association 2017 Standards of Medical Care.
ADA updates it standards annually based on new information and research; like its predecessors, the 2017 guidance is comprehensive, addressing mental, social, and other challenges faced by patients with diabetes, along with clinical care (Diabetes Care. 2017 Jan;40(Suppl 1):S4-S5).
The 2017 guidance contains a great deal of new information. At 135 pages, there are 22 more pages than in 2016. “They did a really nice job. This guide is useful for anyone helping patients with diabetes,” including diabetologists, dietitians, educators, psychologists, and social workers, Richard Hellman, MD, a clinical endocrinologist in North Kansas City, Mo., said in an interview.
The empagliflozin and liraglutide recommendation applies to any patient with type 2 diabetes who has a history of stroke, heart attack, acute coronary syndrome, angina, or peripheral arterial disease. Data from recent trials have shown use of the drugs modestly reduces cardiovascular mortality in this population.
It’s unclear if the benefits are drug specific or group effects. “We anxiously await the results of several ongoing cardiovascular outcomes trials” to find out, said Helena Rodbard, MD, a clinical endocrinologist in Rockville, Md., who also commented on the new standards.
Basal insulin plus a GLP-1 receptor agonist, like liraglutide, are also now recommended for insulin-dependent type 2 disease. “This combination gives rise to a markedly reduced risk of hypoglycemia compared with basal insulin ... basal bolus insulin, or premixed insulins,” according to the ADA.
The newer drugs and insulins are expensive. To help doctors and patients negotiate the price hurdle, ADA added tables on how much the various options cost per month. It was a good move; “the cost of care is going up so fast” in diabetes “that many patients can no longer afford” what’s prescribed. “It’s a major problem,” said Dr. Hellman, clinical professor at the University of Missouri–Kansas City.
The ADA also set a blood glucose level of 54 mg/dL to trigger aggressive hypoglycemia treatment. “There has been confusion over when to treat aggressively. It was a good choice to land on 54 mg/dL” a safe, conservative number a bit higher than others have suggested, Dr. Hellman said.
Meanwhile, the group lowered its metabolic surgery cut point – the ADA has stopped using the term “bariatric surgery” – to type 2 patients with a body mass index of 30 kg/m2 when medications don’t work. The group also set a new hypertension treatment target of 120-160/80-105 mm Hg in pregnancy, and said that insulin is the treatment of choice for gestational diabetes, given concerns about metformin crossing the placenta and glyburide in cord blood.
The ADA expanded its list of diabetes comorbidities to include autoimmune disease, HIV, anxiety, depression, and disordered eating. In addition, doctors should ask patients how well they sleep – since sleep problems affect glycemic control – and should intervene when there’s a problem, according to the guidance.
The group updated its combination injection algorithm for type 2 diabetes “to reflect studies demonstrating the noninferiority of basal insulin plus” liraglutide and its class members “versus basal insulin plus rapid-acting insulin” or two daily injections of premixed insulin. The ADA added a section on the role of newly available biosimilar insulins, as well, and clarified that either basal insulin or basal plus bolus correctional insulin can be used to treat noncritical inpatients, but noted that “sole use of sliding scale insulin in the inpatient hospital setting is strongly discouraged.”
People on long-term metformin should have their vitamin B12 checked periodically, because of new evidence about the risk of B12 deficiency, the group said, and “due to the risk of malformations associated with unplanned pregnancies and poor metabolic control.” The group added “a new recommendation ... encouraging preconception counseling starting at puberty for all girls of childbearing potential.”
“Even though most of this information should be well known to practitioners treating patients, [it’s] a worthwhile read for everyone who treats people with diabetes,” Dr. Rodbard said.
The majority of the people on the ADA’s update committee had no disclosures, but a few reported ties to various companies, including Novo Nordisk, the maker of liraglutide, and Boehringer Ingelheim and Lilly, the companies that developed and/or marketed empagliflozin. Dr. Hellman had no conflicts. Dr. Rodbard is an adviser or researcher for AstraZeneca, Lilly, Janssen, Merck, Novo Nordisk, Sanofi, and Regeneron.
to reduce the risk of CV death, according to the American Diabetes Association 2017 Standards of Medical Care.
ADA updates it standards annually based on new information and research; like its predecessors, the 2017 guidance is comprehensive, addressing mental, social, and other challenges faced by patients with diabetes, along with clinical care (Diabetes Care. 2017 Jan;40(Suppl 1):S4-S5).
The 2017 guidance contains a great deal of new information. At 135 pages, there are 22 more pages than in 2016. “They did a really nice job. This guide is useful for anyone helping patients with diabetes,” including diabetologists, dietitians, educators, psychologists, and social workers, Richard Hellman, MD, a clinical endocrinologist in North Kansas City, Mo., said in an interview.
The empagliflozin and liraglutide recommendation applies to any patient with type 2 diabetes who has a history of stroke, heart attack, acute coronary syndrome, angina, or peripheral arterial disease. Data from recent trials have shown use of the drugs modestly reduces cardiovascular mortality in this population.
It’s unclear if the benefits are drug specific or group effects. “We anxiously await the results of several ongoing cardiovascular outcomes trials” to find out, said Helena Rodbard, MD, a clinical endocrinologist in Rockville, Md., who also commented on the new standards.
Basal insulin plus a GLP-1 receptor agonist, like liraglutide, are also now recommended for insulin-dependent type 2 disease. “This combination gives rise to a markedly reduced risk of hypoglycemia compared with basal insulin ... basal bolus insulin, or premixed insulins,” according to the ADA.
The newer drugs and insulins are expensive. To help doctors and patients negotiate the price hurdle, ADA added tables on how much the various options cost per month. It was a good move; “the cost of care is going up so fast” in diabetes “that many patients can no longer afford” what’s prescribed. “It’s a major problem,” said Dr. Hellman, clinical professor at the University of Missouri–Kansas City.
The ADA also set a blood glucose level of 54 mg/dL to trigger aggressive hypoglycemia treatment. “There has been confusion over when to treat aggressively. It was a good choice to land on 54 mg/dL” a safe, conservative number a bit higher than others have suggested, Dr. Hellman said.
Meanwhile, the group lowered its metabolic surgery cut point – the ADA has stopped using the term “bariatric surgery” – to type 2 patients with a body mass index of 30 kg/m2 when medications don’t work. The group also set a new hypertension treatment target of 120-160/80-105 mm Hg in pregnancy, and said that insulin is the treatment of choice for gestational diabetes, given concerns about metformin crossing the placenta and glyburide in cord blood.
The ADA expanded its list of diabetes comorbidities to include autoimmune disease, HIV, anxiety, depression, and disordered eating. In addition, doctors should ask patients how well they sleep – since sleep problems affect glycemic control – and should intervene when there’s a problem, according to the guidance.
The group updated its combination injection algorithm for type 2 diabetes “to reflect studies demonstrating the noninferiority of basal insulin plus” liraglutide and its class members “versus basal insulin plus rapid-acting insulin” or two daily injections of premixed insulin. The ADA added a section on the role of newly available biosimilar insulins, as well, and clarified that either basal insulin or basal plus bolus correctional insulin can be used to treat noncritical inpatients, but noted that “sole use of sliding scale insulin in the inpatient hospital setting is strongly discouraged.”
People on long-term metformin should have their vitamin B12 checked periodically, because of new evidence about the risk of B12 deficiency, the group said, and “due to the risk of malformations associated with unplanned pregnancies and poor metabolic control.” The group added “a new recommendation ... encouraging preconception counseling starting at puberty for all girls of childbearing potential.”
“Even though most of this information should be well known to practitioners treating patients, [it’s] a worthwhile read for everyone who treats people with diabetes,” Dr. Rodbard said.
The majority of the people on the ADA’s update committee had no disclosures, but a few reported ties to various companies, including Novo Nordisk, the maker of liraglutide, and Boehringer Ingelheim and Lilly, the companies that developed and/or marketed empagliflozin. Dr. Hellman had no conflicts. Dr. Rodbard is an adviser or researcher for AstraZeneca, Lilly, Janssen, Merck, Novo Nordisk, Sanofi, and Regeneron.
to reduce the risk of CV death, according to the American Diabetes Association 2017 Standards of Medical Care.
ADA updates it standards annually based on new information and research; like its predecessors, the 2017 guidance is comprehensive, addressing mental, social, and other challenges faced by patients with diabetes, along with clinical care (Diabetes Care. 2017 Jan;40(Suppl 1):S4-S5).
The 2017 guidance contains a great deal of new information. At 135 pages, there are 22 more pages than in 2016. “They did a really nice job. This guide is useful for anyone helping patients with diabetes,” including diabetologists, dietitians, educators, psychologists, and social workers, Richard Hellman, MD, a clinical endocrinologist in North Kansas City, Mo., said in an interview.
The empagliflozin and liraglutide recommendation applies to any patient with type 2 diabetes who has a history of stroke, heart attack, acute coronary syndrome, angina, or peripheral arterial disease. Data from recent trials have shown use of the drugs modestly reduces cardiovascular mortality in this population.
It’s unclear if the benefits are drug specific or group effects. “We anxiously await the results of several ongoing cardiovascular outcomes trials” to find out, said Helena Rodbard, MD, a clinical endocrinologist in Rockville, Md., who also commented on the new standards.
Basal insulin plus a GLP-1 receptor agonist, like liraglutide, are also now recommended for insulin-dependent type 2 disease. “This combination gives rise to a markedly reduced risk of hypoglycemia compared with basal insulin ... basal bolus insulin, or premixed insulins,” according to the ADA.
The newer drugs and insulins are expensive. To help doctors and patients negotiate the price hurdle, ADA added tables on how much the various options cost per month. It was a good move; “the cost of care is going up so fast” in diabetes “that many patients can no longer afford” what’s prescribed. “It’s a major problem,” said Dr. Hellman, clinical professor at the University of Missouri–Kansas City.
The ADA also set a blood glucose level of 54 mg/dL to trigger aggressive hypoglycemia treatment. “There has been confusion over when to treat aggressively. It was a good choice to land on 54 mg/dL” a safe, conservative number a bit higher than others have suggested, Dr. Hellman said.
Meanwhile, the group lowered its metabolic surgery cut point – the ADA has stopped using the term “bariatric surgery” – to type 2 patients with a body mass index of 30 kg/m2 when medications don’t work. The group also set a new hypertension treatment target of 120-160/80-105 mm Hg in pregnancy, and said that insulin is the treatment of choice for gestational diabetes, given concerns about metformin crossing the placenta and glyburide in cord blood.
The ADA expanded its list of diabetes comorbidities to include autoimmune disease, HIV, anxiety, depression, and disordered eating. In addition, doctors should ask patients how well they sleep – since sleep problems affect glycemic control – and should intervene when there’s a problem, according to the guidance.
The group updated its combination injection algorithm for type 2 diabetes “to reflect studies demonstrating the noninferiority of basal insulin plus” liraglutide and its class members “versus basal insulin plus rapid-acting insulin” or two daily injections of premixed insulin. The ADA added a section on the role of newly available biosimilar insulins, as well, and clarified that either basal insulin or basal plus bolus correctional insulin can be used to treat noncritical inpatients, but noted that “sole use of sliding scale insulin in the inpatient hospital setting is strongly discouraged.”
People on long-term metformin should have their vitamin B12 checked periodically, because of new evidence about the risk of B12 deficiency, the group said, and “due to the risk of malformations associated with unplanned pregnancies and poor metabolic control.” The group added “a new recommendation ... encouraging preconception counseling starting at puberty for all girls of childbearing potential.”
“Even though most of this information should be well known to practitioners treating patients, [it’s] a worthwhile read for everyone who treats people with diabetes,” Dr. Rodbard said.
The majority of the people on the ADA’s update committee had no disclosures, but a few reported ties to various companies, including Novo Nordisk, the maker of liraglutide, and Boehringer Ingelheim and Lilly, the companies that developed and/or marketed empagliflozin. Dr. Hellman had no conflicts. Dr. Rodbard is an adviser or researcher for AstraZeneca, Lilly, Janssen, Merck, Novo Nordisk, Sanofi, and Regeneron.
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
ASCO and AHA: Maintain high suspicion for cardiac dysfunction
Maintain a high suspicion for cardiac dysfunction and a low threshold for cardiac assessment with any patients who are survivors of adult cancers and may have received cardiotoxic therapy, a new guideline suggests.
The guideline, released by the American Society of Clinical Oncology and endorsed by the American Heart Association, is intended to assist primary care physicians, oncologists, cardiologists, and any members of multidisciplinary cancer care teams in preventing and monitoring systolic cardiac dysfunction, which is “typically detected as low left ventricular ejection fraction,” said Saro H. Armenian, DO, and his associates on the expert panel that drafted the guidelines.
To develop the guidelines, the panel conducted a systematic review of 8 metaanalyses, 12 randomized clinical trials, 49 cohort studies, 32 before-and-after studies, and 3 cross-sectional studies published in 1999-2016. They addressed five key questions: Which cancer survivors are at increased risk for developing cardiac dysfunction? Which preventive strategies minimize that risk before cancer therapy is initiated? Which preventive strategies minimize that risk during administration of potentially cardiotoxic cancer therapies? Which cardiac monitoring approaches are preferred during cancer therapies? And which cardiac monitoring approaches are preferred after cancer therapy is completed?
Regarding the fifth question, the guideline advises clinicians to regularly assess and manage cardiovascular risk factors such as smoking, hypertension, diabetes, dyslipidemia, and obesity in survivors of adult cancers, as well as to complete careful histories and physical examinations regularly. Any signs or symptoms that raise the suspicion of cardiac dysfunction should prompt an ECG (or cardiac MRI or multigated acquisition if an ECG isn’t available or technically feasible), assays of serum cardiac biomarkers, and, depending on the findings of these assessments, referral to a cardiologist.
“Patients also need to be advised that cardiac dysfunction can be a progressive disorder and may initially be asymptomatic; therefore, early and late warning signs and symptoms should be discussed,” said Dr. Armenian, a pediatric hematologist/oncologist and director of outcomes research in the department of population sciences at City of Hope in Duarte, Calif., and his associates.
The guideline also includes a special section concerning health disparities. “Patients with cancer who are members of racial or ethnic minorities suffer disproportionately from comorbidities, experience more obstacles to receiving care, are more likely to be uninsured, and are at greater risk of receiving care of poor quality than other Americans. [They] may have a substantially higher burden of cardiovascular complications during and after cancer treatment, in part because of inequities in the management of cardiovascular risk factors,” the guidelines state (J Clin Oncol. 2016 Dec 5 [doi:10.1200/JCO.2016.70.5400]).
A copy of the guideline and further information, including a data supplement, a methodology supplement, slide sets, and clinical tools and resources, are available at www.asco.org/cardiac-guidelineThis guideline was supported by the American Society of Clinical Oncology. Dr. Armenian reported having no relevant financial disclosures; his associates reported ties to numerous industry sources.
Maintain a high suspicion for cardiac dysfunction and a low threshold for cardiac assessment with any patients who are survivors of adult cancers and may have received cardiotoxic therapy, a new guideline suggests.
The guideline, released by the American Society of Clinical Oncology and endorsed by the American Heart Association, is intended to assist primary care physicians, oncologists, cardiologists, and any members of multidisciplinary cancer care teams in preventing and monitoring systolic cardiac dysfunction, which is “typically detected as low left ventricular ejection fraction,” said Saro H. Armenian, DO, and his associates on the expert panel that drafted the guidelines.
To develop the guidelines, the panel conducted a systematic review of 8 metaanalyses, 12 randomized clinical trials, 49 cohort studies, 32 before-and-after studies, and 3 cross-sectional studies published in 1999-2016. They addressed five key questions: Which cancer survivors are at increased risk for developing cardiac dysfunction? Which preventive strategies minimize that risk before cancer therapy is initiated? Which preventive strategies minimize that risk during administration of potentially cardiotoxic cancer therapies? Which cardiac monitoring approaches are preferred during cancer therapies? And which cardiac monitoring approaches are preferred after cancer therapy is completed?
Regarding the fifth question, the guideline advises clinicians to regularly assess and manage cardiovascular risk factors such as smoking, hypertension, diabetes, dyslipidemia, and obesity in survivors of adult cancers, as well as to complete careful histories and physical examinations regularly. Any signs or symptoms that raise the suspicion of cardiac dysfunction should prompt an ECG (or cardiac MRI or multigated acquisition if an ECG isn’t available or technically feasible), assays of serum cardiac biomarkers, and, depending on the findings of these assessments, referral to a cardiologist.
“Patients also need to be advised that cardiac dysfunction can be a progressive disorder and may initially be asymptomatic; therefore, early and late warning signs and symptoms should be discussed,” said Dr. Armenian, a pediatric hematologist/oncologist and director of outcomes research in the department of population sciences at City of Hope in Duarte, Calif., and his associates.
The guideline also includes a special section concerning health disparities. “Patients with cancer who are members of racial or ethnic minorities suffer disproportionately from comorbidities, experience more obstacles to receiving care, are more likely to be uninsured, and are at greater risk of receiving care of poor quality than other Americans. [They] may have a substantially higher burden of cardiovascular complications during and after cancer treatment, in part because of inequities in the management of cardiovascular risk factors,” the guidelines state (J Clin Oncol. 2016 Dec 5 [doi:10.1200/JCO.2016.70.5400]).
A copy of the guideline and further information, including a data supplement, a methodology supplement, slide sets, and clinical tools and resources, are available at www.asco.org/cardiac-guidelineThis guideline was supported by the American Society of Clinical Oncology. Dr. Armenian reported having no relevant financial disclosures; his associates reported ties to numerous industry sources.
Maintain a high suspicion for cardiac dysfunction and a low threshold for cardiac assessment with any patients who are survivors of adult cancers and may have received cardiotoxic therapy, a new guideline suggests.
The guideline, released by the American Society of Clinical Oncology and endorsed by the American Heart Association, is intended to assist primary care physicians, oncologists, cardiologists, and any members of multidisciplinary cancer care teams in preventing and monitoring systolic cardiac dysfunction, which is “typically detected as low left ventricular ejection fraction,” said Saro H. Armenian, DO, and his associates on the expert panel that drafted the guidelines.
To develop the guidelines, the panel conducted a systematic review of 8 metaanalyses, 12 randomized clinical trials, 49 cohort studies, 32 before-and-after studies, and 3 cross-sectional studies published in 1999-2016. They addressed five key questions: Which cancer survivors are at increased risk for developing cardiac dysfunction? Which preventive strategies minimize that risk before cancer therapy is initiated? Which preventive strategies minimize that risk during administration of potentially cardiotoxic cancer therapies? Which cardiac monitoring approaches are preferred during cancer therapies? And which cardiac monitoring approaches are preferred after cancer therapy is completed?
Regarding the fifth question, the guideline advises clinicians to regularly assess and manage cardiovascular risk factors such as smoking, hypertension, diabetes, dyslipidemia, and obesity in survivors of adult cancers, as well as to complete careful histories and physical examinations regularly. Any signs or symptoms that raise the suspicion of cardiac dysfunction should prompt an ECG (or cardiac MRI or multigated acquisition if an ECG isn’t available or technically feasible), assays of serum cardiac biomarkers, and, depending on the findings of these assessments, referral to a cardiologist.
“Patients also need to be advised that cardiac dysfunction can be a progressive disorder and may initially be asymptomatic; therefore, early and late warning signs and symptoms should be discussed,” said Dr. Armenian, a pediatric hematologist/oncologist and director of outcomes research in the department of population sciences at City of Hope in Duarte, Calif., and his associates.
The guideline also includes a special section concerning health disparities. “Patients with cancer who are members of racial or ethnic minorities suffer disproportionately from comorbidities, experience more obstacles to receiving care, are more likely to be uninsured, and are at greater risk of receiving care of poor quality than other Americans. [They] may have a substantially higher burden of cardiovascular complications during and after cancer treatment, in part because of inequities in the management of cardiovascular risk factors,” the guidelines state (J Clin Oncol. 2016 Dec 5 [doi:10.1200/JCO.2016.70.5400]).
A copy of the guideline and further information, including a data supplement, a methodology supplement, slide sets, and clinical tools and resources, are available at www.asco.org/cardiac-guidelineThis guideline was supported by the American Society of Clinical Oncology. Dr. Armenian reported having no relevant financial disclosures; his associates reported ties to numerous industry sources.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
New guidelines provide standardized hypoglycemia values for clinical evaluation
, joining with the European Association for the Study of Diabetes to specify that a level of less than 3 mmol/L (54 mg/dL) should be considered “clinically important hypoglycemia.”
“A single glucose level should be agreed to that has serious clinical and health-economic consequences,” the ADA and EASD stated in the new guidelines. “This would enable the diabetes and regulatory communities to compare the effectiveness of interventions in reducing hypoglycemia, be they pharmacological, technological, or educational. It would also permit the use of meta-analysis as a statistical tool to increase power when comparing interventions.”
An international, multidisciplinary group – the International Hypoglycemia Study Group – was formed to create distinct definitions of the various levels of severity that hypoglycemia can have. The new guidelines contain three levels, which should be used by clinicians to determine what amounts of blood glucose are significant enough to be clinically reported.
“Currently, there is no uniform agreement to what constitutes reportable hypoglycemia in clinical trials,” she said. “In some studies, it is defined as a blood glucose level of less than 70 mg/dL, whereas in others it is defined as a blood glucose level less than 54 mg/dL.”
The guidelines define first-level hypoglycemia as any glucose level of 3.9 mmol/L (70 mg/dL) or less. This is not considered low enough to be reported on a consistent basis in clinical studies; however, that determination must ultimately be made by the investigators, as the parameters for what is significant often vary from study to study.
The second level is the 3 mmol/L (54 mg/dL), which now is deemed to be a clinically significant level of hypoglycemia. Because it is “sufficiently low to indicate serious, clinically important hypoglycemia,” it should be reported as part of any clinical studies. Finally, the third level, less than 2.8 mmol/L (50 mg/dL), indicates severe hypoglycemia and is classified as any individual with “severe cognitive impairment requiring external assistance for recovery,” according to the guidelines (Diabetes Care. 2016 Dec 1. doi: 10.2337/dc16-2215).
With a new standard of hypoglycemic values that are deemed clinically significant, the ADA and EASD hope that comparing different insulins, medications, technologies, and educational interventions will now become easier and more standardized, leading to better care worldwide.
Although there is general agreement as to where severe hypoglycemia really begins, the newly defined glucose levels are “a step in the right direction,” according to Dr. Rodbard.
The International Hypoglycaemia Study Group developed these guidelines through a grant from Novo Nordisk, awarded to the Six Degrees Academy of Toronto. Dr. Heller has received advisory or consultation fees from Lilly, Novo Nordisk, Takeda, Merck, Sharp & Dohme, and Becton Dickinson; has served as a speaker for AstraZeneca, Lilly, Novo Nordisk, Boehringer Ingelheim, and Takeda; and has received research support from Medtronic U.K. Dr. Rodbard did not report any financial disclosures.
, joining with the European Association for the Study of Diabetes to specify that a level of less than 3 mmol/L (54 mg/dL) should be considered “clinically important hypoglycemia.”
“A single glucose level should be agreed to that has serious clinical and health-economic consequences,” the ADA and EASD stated in the new guidelines. “This would enable the diabetes and regulatory communities to compare the effectiveness of interventions in reducing hypoglycemia, be they pharmacological, technological, or educational. It would also permit the use of meta-analysis as a statistical tool to increase power when comparing interventions.”
An international, multidisciplinary group – the International Hypoglycemia Study Group – was formed to create distinct definitions of the various levels of severity that hypoglycemia can have. The new guidelines contain three levels, which should be used by clinicians to determine what amounts of blood glucose are significant enough to be clinically reported.
“Currently, there is no uniform agreement to what constitutes reportable hypoglycemia in clinical trials,” she said. “In some studies, it is defined as a blood glucose level of less than 70 mg/dL, whereas in others it is defined as a blood glucose level less than 54 mg/dL.”
The guidelines define first-level hypoglycemia as any glucose level of 3.9 mmol/L (70 mg/dL) or less. This is not considered low enough to be reported on a consistent basis in clinical studies; however, that determination must ultimately be made by the investigators, as the parameters for what is significant often vary from study to study.
The second level is the 3 mmol/L (54 mg/dL), which now is deemed to be a clinically significant level of hypoglycemia. Because it is “sufficiently low to indicate serious, clinically important hypoglycemia,” it should be reported as part of any clinical studies. Finally, the third level, less than 2.8 mmol/L (50 mg/dL), indicates severe hypoglycemia and is classified as any individual with “severe cognitive impairment requiring external assistance for recovery,” according to the guidelines (Diabetes Care. 2016 Dec 1. doi: 10.2337/dc16-2215).
With a new standard of hypoglycemic values that are deemed clinically significant, the ADA and EASD hope that comparing different insulins, medications, technologies, and educational interventions will now become easier and more standardized, leading to better care worldwide.
Although there is general agreement as to where severe hypoglycemia really begins, the newly defined glucose levels are “a step in the right direction,” according to Dr. Rodbard.
The International Hypoglycaemia Study Group developed these guidelines through a grant from Novo Nordisk, awarded to the Six Degrees Academy of Toronto. Dr. Heller has received advisory or consultation fees from Lilly, Novo Nordisk, Takeda, Merck, Sharp & Dohme, and Becton Dickinson; has served as a speaker for AstraZeneca, Lilly, Novo Nordisk, Boehringer Ingelheim, and Takeda; and has received research support from Medtronic U.K. Dr. Rodbard did not report any financial disclosures.
, joining with the European Association for the Study of Diabetes to specify that a level of less than 3 mmol/L (54 mg/dL) should be considered “clinically important hypoglycemia.”
“A single glucose level should be agreed to that has serious clinical and health-economic consequences,” the ADA and EASD stated in the new guidelines. “This would enable the diabetes and regulatory communities to compare the effectiveness of interventions in reducing hypoglycemia, be they pharmacological, technological, or educational. It would also permit the use of meta-analysis as a statistical tool to increase power when comparing interventions.”
An international, multidisciplinary group – the International Hypoglycemia Study Group – was formed to create distinct definitions of the various levels of severity that hypoglycemia can have. The new guidelines contain three levels, which should be used by clinicians to determine what amounts of blood glucose are significant enough to be clinically reported.
“Currently, there is no uniform agreement to what constitutes reportable hypoglycemia in clinical trials,” she said. “In some studies, it is defined as a blood glucose level of less than 70 mg/dL, whereas in others it is defined as a blood glucose level less than 54 mg/dL.”
The guidelines define first-level hypoglycemia as any glucose level of 3.9 mmol/L (70 mg/dL) or less. This is not considered low enough to be reported on a consistent basis in clinical studies; however, that determination must ultimately be made by the investigators, as the parameters for what is significant often vary from study to study.
The second level is the 3 mmol/L (54 mg/dL), which now is deemed to be a clinically significant level of hypoglycemia. Because it is “sufficiently low to indicate serious, clinically important hypoglycemia,” it should be reported as part of any clinical studies. Finally, the third level, less than 2.8 mmol/L (50 mg/dL), indicates severe hypoglycemia and is classified as any individual with “severe cognitive impairment requiring external assistance for recovery,” according to the guidelines (Diabetes Care. 2016 Dec 1. doi: 10.2337/dc16-2215).
With a new standard of hypoglycemic values that are deemed clinically significant, the ADA and EASD hope that comparing different insulins, medications, technologies, and educational interventions will now become easier and more standardized, leading to better care worldwide.
Although there is general agreement as to where severe hypoglycemia really begins, the newly defined glucose levels are “a step in the right direction,” according to Dr. Rodbard.
The International Hypoglycaemia Study Group developed these guidelines through a grant from Novo Nordisk, awarded to the Six Degrees Academy of Toronto. Dr. Heller has received advisory or consultation fees from Lilly, Novo Nordisk, Takeda, Merck, Sharp & Dohme, and Becton Dickinson; has served as a speaker for AstraZeneca, Lilly, Novo Nordisk, Boehringer Ingelheim, and Takeda; and has received research support from Medtronic U.K. Dr. Rodbard did not report any financial disclosures.
Guideline: Supplemental, dietary calcium both heart safe
Both dietary and supplemental calcium should be considered safe for the cardiovascular system as long as total intake doesn’t exceed 2,000-2,500 mg/day – the maximal tolerable level defined by the National Academy of Medicine, according to an updated Clinical Practice Guideline published online October 24 in Annals of Internal Medicine.
For generally healthy patients who don’t consume adequate calcium and take supplements, either alone or in combination with vitamin D, to prevent osteoporosis and related fractures, “discontinuation of supplemental calcium for safety reasons is not necessary and may be harmful to bone health,” said Stephen L. Kopecky, MD, of the Mayo Clinic, Rochester Minn., and his associates on the expert panel that wrote the new guideline.
The National Osteoporosis Foundation (NOF) and the American Society for Preventive Cardiology (ASPC) commissioned an independent review of the current evidence to update the Evidence Report and assembled the expert panel to write the guideline based on the new findings (Ann Intern Med. 2016 Oct 24. doi: 10.7326/M16-1743).
Separately, Mei Chung, PhD, of the department of public health and community medicine, and her associates at Tufts University, Boston, reviewed 4 recent randomized clinical trials, 1 nested case-control study, and 26 cohort studies that assessed the effects of calcium intake on 17 health outcomes in generally healthy adults of all ages. None of the studies evaluated cardiovascular disease risk as a primary outcome. “We conclude that calcium intake (from either food or supplement sources) at levels within the recommended tolerable upper intake range (2,000-2,500 mg/d) are not associated with CVD risks in generally healthy adults,” they said.
“Although a few trials and cohort studies reported increased risks with higher calcium intake, risk estimates in most of those studies were small (10% relative risk) and not considered clinically important, even if they were statistically significant,” Dr. Chung and her associates added (Ann Int Med. 2016 Oct 24. doi: 10.7326/M16-1165).
According to the guideline, “The NOF and the ASPC now adopt the position that there is moderate-quality evidence that calcium with or without vitamin D intake from food or supplements has no relationship (beneficial or harmful) with the risk for cardiovascular or cerebrovascular disease, mortality, or all-cause mortality in generally healthy adults at this time.”
In addition, “Currently, no established biological mechanism supports and association between calcium and cardiovascular disease,” Dr. Kopecky and his associates on the expert panel noted.
The volume of literature on the subject of calcium’s potential harmful cardiovascular disease effects appears to be robust, with the largest meta-analysis to date including 18 studies with 64,000 participants. But this evidence base has some limitations, chief among them the fact that none of the studies was designed to evaluate CVD as a primary outcome.
In addition, concerns about harmful cardiovascular effects arose after most of the trials had already been initiated, so unpublished data on those outcomes were collected and adjudicated retrospectively. In addition, many of the participants showed poor long-term treatment adherence, making it difficult to interpret the data.
Karen L. Margolis, MD, of HealthPartners Institute in Minneapolis and JoAnn E. Manson, MD, DrPH, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, made these remarks in an editorial accompanying the new Clinical Practice Guideline (Ann Intern Med. 2016 Oct 24. doi: 10.7326/M16-2193). Their financial disclosures are available at www.acponline.org.
The volume of literature on the subject of calcium’s potential harmful cardiovascular disease effects appears to be robust, with the largest meta-analysis to date including 18 studies with 64,000 participants. But this evidence base has some limitations, chief among them the fact that none of the studies was designed to evaluate CVD as a primary outcome.
In addition, concerns about harmful cardiovascular effects arose after most of the trials had already been initiated, so unpublished data on those outcomes were collected and adjudicated retrospectively. In addition, many of the participants showed poor long-term treatment adherence, making it difficult to interpret the data.
Karen L. Margolis, MD, of HealthPartners Institute in Minneapolis and JoAnn E. Manson, MD, DrPH, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, made these remarks in an editorial accompanying the new Clinical Practice Guideline (Ann Intern Med. 2016 Oct 24. doi: 10.7326/M16-2193). Their financial disclosures are available at www.acponline.org.
The volume of literature on the subject of calcium’s potential harmful cardiovascular disease effects appears to be robust, with the largest meta-analysis to date including 18 studies with 64,000 participants. But this evidence base has some limitations, chief among them the fact that none of the studies was designed to evaluate CVD as a primary outcome.
In addition, concerns about harmful cardiovascular effects arose after most of the trials had already been initiated, so unpublished data on those outcomes were collected and adjudicated retrospectively. In addition, many of the participants showed poor long-term treatment adherence, making it difficult to interpret the data.
Karen L. Margolis, MD, of HealthPartners Institute in Minneapolis and JoAnn E. Manson, MD, DrPH, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, made these remarks in an editorial accompanying the new Clinical Practice Guideline (Ann Intern Med. 2016 Oct 24. doi: 10.7326/M16-2193). Their financial disclosures are available at www.acponline.org.
Both dietary and supplemental calcium should be considered safe for the cardiovascular system as long as total intake doesn’t exceed 2,000-2,500 mg/day – the maximal tolerable level defined by the National Academy of Medicine, according to an updated Clinical Practice Guideline published online October 24 in Annals of Internal Medicine.
For generally healthy patients who don’t consume adequate calcium and take supplements, either alone or in combination with vitamin D, to prevent osteoporosis and related fractures, “discontinuation of supplemental calcium for safety reasons is not necessary and may be harmful to bone health,” said Stephen L. Kopecky, MD, of the Mayo Clinic, Rochester Minn., and his associates on the expert panel that wrote the new guideline.
The National Osteoporosis Foundation (NOF) and the American Society for Preventive Cardiology (ASPC) commissioned an independent review of the current evidence to update the Evidence Report and assembled the expert panel to write the guideline based on the new findings (Ann Intern Med. 2016 Oct 24. doi: 10.7326/M16-1743).
Separately, Mei Chung, PhD, of the department of public health and community medicine, and her associates at Tufts University, Boston, reviewed 4 recent randomized clinical trials, 1 nested case-control study, and 26 cohort studies that assessed the effects of calcium intake on 17 health outcomes in generally healthy adults of all ages. None of the studies evaluated cardiovascular disease risk as a primary outcome. “We conclude that calcium intake (from either food or supplement sources) at levels within the recommended tolerable upper intake range (2,000-2,500 mg/d) are not associated with CVD risks in generally healthy adults,” they said.
“Although a few trials and cohort studies reported increased risks with higher calcium intake, risk estimates in most of those studies were small (10% relative risk) and not considered clinically important, even if they were statistically significant,” Dr. Chung and her associates added (Ann Int Med. 2016 Oct 24. doi: 10.7326/M16-1165).
According to the guideline, “The NOF and the ASPC now adopt the position that there is moderate-quality evidence that calcium with or without vitamin D intake from food or supplements has no relationship (beneficial or harmful) with the risk for cardiovascular or cerebrovascular disease, mortality, or all-cause mortality in generally healthy adults at this time.”
In addition, “Currently, no established biological mechanism supports and association between calcium and cardiovascular disease,” Dr. Kopecky and his associates on the expert panel noted.
Both dietary and supplemental calcium should be considered safe for the cardiovascular system as long as total intake doesn’t exceed 2,000-2,500 mg/day – the maximal tolerable level defined by the National Academy of Medicine, according to an updated Clinical Practice Guideline published online October 24 in Annals of Internal Medicine.
For generally healthy patients who don’t consume adequate calcium and take supplements, either alone or in combination with vitamin D, to prevent osteoporosis and related fractures, “discontinuation of supplemental calcium for safety reasons is not necessary and may be harmful to bone health,” said Stephen L. Kopecky, MD, of the Mayo Clinic, Rochester Minn., and his associates on the expert panel that wrote the new guideline.
The National Osteoporosis Foundation (NOF) and the American Society for Preventive Cardiology (ASPC) commissioned an independent review of the current evidence to update the Evidence Report and assembled the expert panel to write the guideline based on the new findings (Ann Intern Med. 2016 Oct 24. doi: 10.7326/M16-1743).
Separately, Mei Chung, PhD, of the department of public health and community medicine, and her associates at Tufts University, Boston, reviewed 4 recent randomized clinical trials, 1 nested case-control study, and 26 cohort studies that assessed the effects of calcium intake on 17 health outcomes in generally healthy adults of all ages. None of the studies evaluated cardiovascular disease risk as a primary outcome. “We conclude that calcium intake (from either food or supplement sources) at levels within the recommended tolerable upper intake range (2,000-2,500 mg/d) are not associated with CVD risks in generally healthy adults,” they said.
“Although a few trials and cohort studies reported increased risks with higher calcium intake, risk estimates in most of those studies were small (10% relative risk) and not considered clinically important, even if they were statistically significant,” Dr. Chung and her associates added (Ann Int Med. 2016 Oct 24. doi: 10.7326/M16-1165).
According to the guideline, “The NOF and the ASPC now adopt the position that there is moderate-quality evidence that calcium with or without vitamin D intake from food or supplements has no relationship (beneficial or harmful) with the risk for cardiovascular or cerebrovascular disease, mortality, or all-cause mortality in generally healthy adults at this time.”
In addition, “Currently, no established biological mechanism supports and association between calcium and cardiovascular disease,” Dr. Kopecky and his associates on the expert panel noted.
CMS offering educational webinars on MACRA
The Centers for Medicare & Medicaid Services is offering a pair of webinars aimed at helping physicians navigate the new regulation that operationalizes the Medicare Access and CHIP Reauthorization Act (MACRA).
The first webinar, scheduled for Oct. 26, will provide an overview of the two components of the Quality Payment Program – the Merit-Based Incentive Payment System (MIPS) and advanced Alternative Payment Models (APMs).
The second webinar, scheduled for Nov. 15, is targeted to Medicare Part B fee-for-service clinicians, office managers and administrators, state and national associations that represent health care providers, and other stakeholders and will feature a question-and-answer session.
The webinars are part of the agency’s ongoing efforts to help educate practitioners on the provisions of the final MACRA regulation, which was issued on Oct. 14. CMS also recently launched a website to help in that regard.
The Centers for Medicare & Medicaid Services is offering a pair of webinars aimed at helping physicians navigate the new regulation that operationalizes the Medicare Access and CHIP Reauthorization Act (MACRA).
The first webinar, scheduled for Oct. 26, will provide an overview of the two components of the Quality Payment Program – the Merit-Based Incentive Payment System (MIPS) and advanced Alternative Payment Models (APMs).
The second webinar, scheduled for Nov. 15, is targeted to Medicare Part B fee-for-service clinicians, office managers and administrators, state and national associations that represent health care providers, and other stakeholders and will feature a question-and-answer session.
The webinars are part of the agency’s ongoing efforts to help educate practitioners on the provisions of the final MACRA regulation, which was issued on Oct. 14. CMS also recently launched a website to help in that regard.
The Centers for Medicare & Medicaid Services is offering a pair of webinars aimed at helping physicians navigate the new regulation that operationalizes the Medicare Access and CHIP Reauthorization Act (MACRA).
The first webinar, scheduled for Oct. 26, will provide an overview of the two components of the Quality Payment Program – the Merit-Based Incentive Payment System (MIPS) and advanced Alternative Payment Models (APMs).
The second webinar, scheduled for Nov. 15, is targeted to Medicare Part B fee-for-service clinicians, office managers and administrators, state and national associations that represent health care providers, and other stakeholders and will feature a question-and-answer session.
The webinars are part of the agency’s ongoing efforts to help educate practitioners on the provisions of the final MACRA regulation, which was issued on Oct. 14. CMS also recently launched a website to help in that regard.
More restrictive hemoglobin threshold recommended for transfusion
New guidelines on red blood cell blood transfusion recommend a restrictive threshold in which transfusion is not indicated until the hemoglobin level is 7-8 g/dL for most patients, finding that it is safe in most clinical settings.
The updated clinical practice guidelines on transfusion thresholds and storage from the AABB (formerly known as the American Association of Blood Banks), also note that red blood cell units can be used at any time within their licensed dating period, rather than a preference being given to fresher units less than 10 days old.
The guidelines, published online Oct. 12 in JAMA, are an update of the 2012 transfusion guidelines, and are a response to a more than doubling of the number of patients since enrolled in randomized controlled trials of red blood cell transfusions.
The AABB’s clinical transfusion medicine committee, led by Jeffrey L. Carson, MD, of Robert Wood Johnson Medical School, New Brunswick, N.J., analyzed data from 31 randomized controlled trials of 12,587 participants, which compared restrictive transfusion thresholds of 7-8 g/dL to more liberal thresholds of 9-10 g/dL.
This analysis showed that the use of restrictive transfusion protocols was associated with an absolute difference in 30-day mortality of three fewer deaths compared to the more liberal thresholds. There was no significant difference in 30-day mortality in trials that compared a threshold of 8-9 g/dL to a threshold of less than 7 g/dL (JAMA 2016, Oct 12. doi: 10.1001/jama.2016.9185).
“For all other outcomes evaluated, there was no evidence to suggest that patients were harmed by restrictive transfusion protocols, although the quality of the evidence was low for the outcomes of congestive heart failure and rebleeding,” the authors reported.
Based on these findings, they recommended a restrictive red blood cell transfusion threshold, in which transfusion is not indicated until the hemoglobin level is 7 g/dL for hospitalized adult patients who are hemodynamically stable, including critically ill patients.
However for patients undergoing orthopedic or cardiac surgery, or those with preexisting cardiovascular disease, they advised a threshold of 8 g/dL for initiating a red blood cell transfusion.
They also stressed that these recommendations did not apply to patients with acute coronary syndrome, those with severe thrombocytopenia, those treated for hematologic or oncologic disorders who at risk of bleeding, and those with chronic transfusion–dependent anemia, citing a lack of quality randomized controlled trial evidence.
The guideline authors examined the issue of the optimal length of time that red blood cell units should be stored, pointing out that there is currently no formal guidance on the optimal period of red blood cell storage prior to transfusion.
While units of red blood cells can be stored for up to 42 days, the committee said there was some evidence that longer storage may be associated with adverse transfusion outcomes.
“The RBCs stored for longer periods have decreased ability to deliver oxygen due to decreased levels of 2,3-diphsophoglycerate, decreased nitric oxide metabolism, alterations of the RBC membrane leading to increased rigidity, and increased RBC endothelial adherence,” they wrote.
Despite this, the review of 13 randomized controlled trials examining the effect of storage duration found no evidence that fresher units had any impact on mortality compared to standard issue units, nor were there any more adverse events with the standard issue units.
The absolute difference in 30-day mortality was four more deaths per 1,000 with fresher blood, and there was a higher risk of nosocomial infections among patients who received fresher red blood cell units although the authors said the quality of evidence was low.
They therefore recommended that no preference be given to fresher red blood cell units, and that all patients be treated with units chosen at any point within their licensed dating period.
Guideline development was supported by AABB. Four authors declared grants, fees, stock options or consultancies from pharmaceutical companies, but no other conflicts of interest were declared.
The two-tiered approach of this important update to the red blood cell transfusion guidelines acknowledges the current state of the evidence and also provides support for making more individualized transfusion decisions.
These new guidelines represent medicine at its best in that they are evidence based, derived from randomized controlled trials, reflect important clinical perspectives, and are definitive for conditions in which data are substantial, but provide greater flexibility for conditions in which data are less certain.
One major limitation of these guidelines is that they are based on hemoglobin level as the transfusion trigger, when good clinical practice dictates that the decision to transfuse should also be based on clinical factors, availability of alternative therapies, and patient preferences.
Mark H. Yazer, MD and Darrell J. Triulzi, MD, are in the division of transfusion medicine at the University of Pittsburgh Medical Center. These comments are adapted from an editorial (JAMA 2016, Oct 12. doi: 10.1001/jama.2016.10887 ). Dr Triulzi reported receiving grants from the National Heart, Lung, and Blood Institute; and receiving personal fees for serving on an advisory board for Fresenius Kabi.
The two-tiered approach of this important update to the red blood cell transfusion guidelines acknowledges the current state of the evidence and also provides support for making more individualized transfusion decisions.
These new guidelines represent medicine at its best in that they are evidence based, derived from randomized controlled trials, reflect important clinical perspectives, and are definitive for conditions in which data are substantial, but provide greater flexibility for conditions in which data are less certain.
One major limitation of these guidelines is that they are based on hemoglobin level as the transfusion trigger, when good clinical practice dictates that the decision to transfuse should also be based on clinical factors, availability of alternative therapies, and patient preferences.
Mark H. Yazer, MD and Darrell J. Triulzi, MD, are in the division of transfusion medicine at the University of Pittsburgh Medical Center. These comments are adapted from an editorial (JAMA 2016, Oct 12. doi: 10.1001/jama.2016.10887 ). Dr Triulzi reported receiving grants from the National Heart, Lung, and Blood Institute; and receiving personal fees for serving on an advisory board for Fresenius Kabi.
The two-tiered approach of this important update to the red blood cell transfusion guidelines acknowledges the current state of the evidence and also provides support for making more individualized transfusion decisions.
These new guidelines represent medicine at its best in that they are evidence based, derived from randomized controlled trials, reflect important clinical perspectives, and are definitive for conditions in which data are substantial, but provide greater flexibility for conditions in which data are less certain.
One major limitation of these guidelines is that they are based on hemoglobin level as the transfusion trigger, when good clinical practice dictates that the decision to transfuse should also be based on clinical factors, availability of alternative therapies, and patient preferences.
Mark H. Yazer, MD and Darrell J. Triulzi, MD, are in the division of transfusion medicine at the University of Pittsburgh Medical Center. These comments are adapted from an editorial (JAMA 2016, Oct 12. doi: 10.1001/jama.2016.10887 ). Dr Triulzi reported receiving grants from the National Heart, Lung, and Blood Institute; and receiving personal fees for serving on an advisory board for Fresenius Kabi.
New guidelines on red blood cell blood transfusion recommend a restrictive threshold in which transfusion is not indicated until the hemoglobin level is 7-8 g/dL for most patients, finding that it is safe in most clinical settings.
The updated clinical practice guidelines on transfusion thresholds and storage from the AABB (formerly known as the American Association of Blood Banks), also note that red blood cell units can be used at any time within their licensed dating period, rather than a preference being given to fresher units less than 10 days old.
The guidelines, published online Oct. 12 in JAMA, are an update of the 2012 transfusion guidelines, and are a response to a more than doubling of the number of patients since enrolled in randomized controlled trials of red blood cell transfusions.
The AABB’s clinical transfusion medicine committee, led by Jeffrey L. Carson, MD, of Robert Wood Johnson Medical School, New Brunswick, N.J., analyzed data from 31 randomized controlled trials of 12,587 participants, which compared restrictive transfusion thresholds of 7-8 g/dL to more liberal thresholds of 9-10 g/dL.
This analysis showed that the use of restrictive transfusion protocols was associated with an absolute difference in 30-day mortality of three fewer deaths compared to the more liberal thresholds. There was no significant difference in 30-day mortality in trials that compared a threshold of 8-9 g/dL to a threshold of less than 7 g/dL (JAMA 2016, Oct 12. doi: 10.1001/jama.2016.9185).
“For all other outcomes evaluated, there was no evidence to suggest that patients were harmed by restrictive transfusion protocols, although the quality of the evidence was low for the outcomes of congestive heart failure and rebleeding,” the authors reported.
Based on these findings, they recommended a restrictive red blood cell transfusion threshold, in which transfusion is not indicated until the hemoglobin level is 7 g/dL for hospitalized adult patients who are hemodynamically stable, including critically ill patients.
However for patients undergoing orthopedic or cardiac surgery, or those with preexisting cardiovascular disease, they advised a threshold of 8 g/dL for initiating a red blood cell transfusion.
They also stressed that these recommendations did not apply to patients with acute coronary syndrome, those with severe thrombocytopenia, those treated for hematologic or oncologic disorders who at risk of bleeding, and those with chronic transfusion–dependent anemia, citing a lack of quality randomized controlled trial evidence.
The guideline authors examined the issue of the optimal length of time that red blood cell units should be stored, pointing out that there is currently no formal guidance on the optimal period of red blood cell storage prior to transfusion.
While units of red blood cells can be stored for up to 42 days, the committee said there was some evidence that longer storage may be associated with adverse transfusion outcomes.
“The RBCs stored for longer periods have decreased ability to deliver oxygen due to decreased levels of 2,3-diphsophoglycerate, decreased nitric oxide metabolism, alterations of the RBC membrane leading to increased rigidity, and increased RBC endothelial adherence,” they wrote.
Despite this, the review of 13 randomized controlled trials examining the effect of storage duration found no evidence that fresher units had any impact on mortality compared to standard issue units, nor were there any more adverse events with the standard issue units.
The absolute difference in 30-day mortality was four more deaths per 1,000 with fresher blood, and there was a higher risk of nosocomial infections among patients who received fresher red blood cell units although the authors said the quality of evidence was low.
They therefore recommended that no preference be given to fresher red blood cell units, and that all patients be treated with units chosen at any point within their licensed dating period.
Guideline development was supported by AABB. Four authors declared grants, fees, stock options or consultancies from pharmaceutical companies, but no other conflicts of interest were declared.
New guidelines on red blood cell blood transfusion recommend a restrictive threshold in which transfusion is not indicated until the hemoglobin level is 7-8 g/dL for most patients, finding that it is safe in most clinical settings.
The updated clinical practice guidelines on transfusion thresholds and storage from the AABB (formerly known as the American Association of Blood Banks), also note that red blood cell units can be used at any time within their licensed dating period, rather than a preference being given to fresher units less than 10 days old.
The guidelines, published online Oct. 12 in JAMA, are an update of the 2012 transfusion guidelines, and are a response to a more than doubling of the number of patients since enrolled in randomized controlled trials of red blood cell transfusions.
The AABB’s clinical transfusion medicine committee, led by Jeffrey L. Carson, MD, of Robert Wood Johnson Medical School, New Brunswick, N.J., analyzed data from 31 randomized controlled trials of 12,587 participants, which compared restrictive transfusion thresholds of 7-8 g/dL to more liberal thresholds of 9-10 g/dL.
This analysis showed that the use of restrictive transfusion protocols was associated with an absolute difference in 30-day mortality of three fewer deaths compared to the more liberal thresholds. There was no significant difference in 30-day mortality in trials that compared a threshold of 8-9 g/dL to a threshold of less than 7 g/dL (JAMA 2016, Oct 12. doi: 10.1001/jama.2016.9185).
“For all other outcomes evaluated, there was no evidence to suggest that patients were harmed by restrictive transfusion protocols, although the quality of the evidence was low for the outcomes of congestive heart failure and rebleeding,” the authors reported.
Based on these findings, they recommended a restrictive red blood cell transfusion threshold, in which transfusion is not indicated until the hemoglobin level is 7 g/dL for hospitalized adult patients who are hemodynamically stable, including critically ill patients.
However for patients undergoing orthopedic or cardiac surgery, or those with preexisting cardiovascular disease, they advised a threshold of 8 g/dL for initiating a red blood cell transfusion.
They also stressed that these recommendations did not apply to patients with acute coronary syndrome, those with severe thrombocytopenia, those treated for hematologic or oncologic disorders who at risk of bleeding, and those with chronic transfusion–dependent anemia, citing a lack of quality randomized controlled trial evidence.
The guideline authors examined the issue of the optimal length of time that red blood cell units should be stored, pointing out that there is currently no formal guidance on the optimal period of red blood cell storage prior to transfusion.
While units of red blood cells can be stored for up to 42 days, the committee said there was some evidence that longer storage may be associated with adverse transfusion outcomes.
“The RBCs stored for longer periods have decreased ability to deliver oxygen due to decreased levels of 2,3-diphsophoglycerate, decreased nitric oxide metabolism, alterations of the RBC membrane leading to increased rigidity, and increased RBC endothelial adherence,” they wrote.
Despite this, the review of 13 randomized controlled trials examining the effect of storage duration found no evidence that fresher units had any impact on mortality compared to standard issue units, nor were there any more adverse events with the standard issue units.
The absolute difference in 30-day mortality was four more deaths per 1,000 with fresher blood, and there was a higher risk of nosocomial infections among patients who received fresher red blood cell units although the authors said the quality of evidence was low.
They therefore recommended that no preference be given to fresher red blood cell units, and that all patients be treated with units chosen at any point within their licensed dating period.
Guideline development was supported by AABB. Four authors declared grants, fees, stock options or consultancies from pharmaceutical companies, but no other conflicts of interest were declared.
FROM JAMA
Key clinical point: A restrictive threshold for red blood cell transfusion, in which transfusion is not indicated until the hemoglobin level is 7-8 g/dL, is now recommended for most patients.
Major finding: A more restrictive threshold for red blood cell transfusion is not associated with an increased risk of mortality or other adverse outcomes from transfusion.
Data source: Updated guidelines from the AABB (formerly known as the American Association of Blood Banks).
Disclosures: Guideline development was supported by AABB. Four authors declared grants, fees, stock options or consultancies from pharmaceutical companies including CSL and Fresenius Kabi, but no other conflicts of interest were declared.