User login
Screening for intimate partner violence and abuse of elderly and vulnerable adults
The U.S. Preventive Services Task Force has released updated recommendations regarding screening for intimate partner violence and abuse of elderly and vulnerable adults. While their previous recommendations in 2004 gave intimate partner violence screening an "I" recommendation, meaning that the evidence was inconclusive regarding the balance of benefits and intimate partner violence harms, the current recommendation has been upgraded to a "B" recommendation, meaning there is moderate certainty that there is a net benefit from screening. This puts the USPSTF recommendation in alignment with those of most other groups, including the American Medical Association and the *American College of Obstetricians and Gynecologists.
Forms of abuse
The recommendations regarding intimate partner violence in these guidelines refer to physical, sexual, or psychological abuse of women of reproductive age by a current or former partner or spouse. The issue of intimate partner violence is important because research shows that approximately 31% of women and 26% of men have experienced intimate partner violence within their lifetime, and that intimate partner violence is usually undetected. It is also estimated that these numbers are likely to be low because of underreporting. In one large study, the 1-year incidence of abuse was 8% within the last year and 15% within the last 5 years. Approximately 1.5%-5% of pregnant women report being abused. Among older and vulnerable adults, the rate of physical, psychological, or sexual abuse; neglect; or financial exploitation is estimated to be between 2% and 10%.
Intimate partner violence has important and long-lasting effects on victims. Harmful effects include immediate injuries resulting from direct trauma as well as long-term physical and mental health consequences. Long-term physical consequences include sexually transmitted diseases, unintended pregnancy, and worse pregnancy outcomes, as well as higher rates of chronic pain, gastrointestinal disorders, migraine headaches, and disability. Long-term mental health consequences include depression, post-traumatic stress disorder, anxiety disorders, substance abuse, and a higher rate of suicide.
Screening of women
Intimate partner violence in women can be detected with a high level of certainty. There are specific factors that can influence the chances that an individual is at risk for intimate partner violence and can alert clinicians to have increased vigilance for abuse. These risk factors have four categories. The first category is individual, focusing on an individual’s self-esteem. The second is relationship, which focuses on marriage conflict and stability within relationships. Third is community, which is looking at socioeconomic background. Fourth are the societal factors of traditional gender roles.
Many screening instruments exist that have been carefully studied. For instance, the HITS instrument, available in English and Spanish, is a four-item questionnaire that asks about being hurt, insulted, screamed at, or threatened. In one study, it had a sensitivity of 86% and a specificity of 99% for detecting intimate partner violence. The interval for screening is not clear.
Treatment
Once intimate partner violence among women is detected, many approaches are available to help these women. For example, one trial was set up to test the effectiveness of a mentoring support group vs. usual care. All women who entered this trial had discussed intimate partner violence with their primary care physician. After the intervention program, the women who were in the intervention group had significantly reduced scores of abuse as opposed to the comparison group. Another example is a study of pregnant women who reported abuse, who were then randomized to a counseling intervention vs. usual care. Women in the counseling group had decreased pregnancy coercion and were more likely to discontinue an unhealthy or unsafe relationship.
Approaches vary from counseling to social work interventions brought to peoples’ homes, information cards, referral to community services, and mentoring support services. It appears that varied interventions decrease recurrent abuse. There is no reported harm in screening for intimate partner violence. It is necessary for the primary care doctor to be aware of the laws specific to intimate partner violence reporting and privacy within the doctor’s specific region.
Elderly and vulnerable adults
In contrast to screening for intimate partner violence in women, there is a lack of evidence for abuse screening in elderly and vulnerable adult populations. There is a lack of evidence on the benefits of detection and, surprisingly, a lack of evidence on the benefits of early intervention. It is also possible that the harms of detecting abuse in this group may be different, although the risk appears to be small. Some potential harm includes shame, guilt, fear of retaliation, and abandonment by caretakers who have been accused of abuse.
While the evidence to support screening elderly and vulnerable adults is limited, state and local laws vary about the obligation and logistics of reporting elderly abuse. A main conclusion of the USPSTF is that more evidence-based research needs to be done for the population of elderly and vulnerable adults.
Bottom line
Intimate partner violence is common, affecting a quarter of all adults at some point in their life. The mental and physical effects of intimate partner violence can be severe and long-lasting. Screening for intimate partner violence is effective, and effective interventions can be carried out to help women who are victims of intimate partner violence. The USPSTF recommends routine screening of women of reproductive age for intimate partner violence. The data on screening for abuse in the elderly and vulnerable adults is insufficient for the USPSTF to make a recommendation for or against screening.
Reference
• Screening for Intimate Partner Violence and Abuse of Elderly and Vulnerable Adults: U.S. Preventive Services Task Force Recommendation Statement. (Ann. Intern. Med. 2013:158;478-86).
Ms. Skolnik attends Drexel University, Philadelphia, and is a research assistant at the Children’s Hospital of Pennsylvania. Dr. Clouse is an associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital.
*Correction 1/23/14: A previous version of this article misstated the name of the American College of Obstetricians and Gynecologists. This version has been updated.
The U.S. Preventive Services Task Force has released updated recommendations regarding screening for intimate partner violence and abuse of elderly and vulnerable adults. While their previous recommendations in 2004 gave intimate partner violence screening an "I" recommendation, meaning that the evidence was inconclusive regarding the balance of benefits and intimate partner violence harms, the current recommendation has been upgraded to a "B" recommendation, meaning there is moderate certainty that there is a net benefit from screening. This puts the USPSTF recommendation in alignment with those of most other groups, including the American Medical Association and the *American College of Obstetricians and Gynecologists.
Forms of abuse
The recommendations regarding intimate partner violence in these guidelines refer to physical, sexual, or psychological abuse of women of reproductive age by a current or former partner or spouse. The issue of intimate partner violence is important because research shows that approximately 31% of women and 26% of men have experienced intimate partner violence within their lifetime, and that intimate partner violence is usually undetected. It is also estimated that these numbers are likely to be low because of underreporting. In one large study, the 1-year incidence of abuse was 8% within the last year and 15% within the last 5 years. Approximately 1.5%-5% of pregnant women report being abused. Among older and vulnerable adults, the rate of physical, psychological, or sexual abuse; neglect; or financial exploitation is estimated to be between 2% and 10%.
Intimate partner violence has important and long-lasting effects on victims. Harmful effects include immediate injuries resulting from direct trauma as well as long-term physical and mental health consequences. Long-term physical consequences include sexually transmitted diseases, unintended pregnancy, and worse pregnancy outcomes, as well as higher rates of chronic pain, gastrointestinal disorders, migraine headaches, and disability. Long-term mental health consequences include depression, post-traumatic stress disorder, anxiety disorders, substance abuse, and a higher rate of suicide.
Screening of women
Intimate partner violence in women can be detected with a high level of certainty. There are specific factors that can influence the chances that an individual is at risk for intimate partner violence and can alert clinicians to have increased vigilance for abuse. These risk factors have four categories. The first category is individual, focusing on an individual’s self-esteem. The second is relationship, which focuses on marriage conflict and stability within relationships. Third is community, which is looking at socioeconomic background. Fourth are the societal factors of traditional gender roles.
Many screening instruments exist that have been carefully studied. For instance, the HITS instrument, available in English and Spanish, is a four-item questionnaire that asks about being hurt, insulted, screamed at, or threatened. In one study, it had a sensitivity of 86% and a specificity of 99% for detecting intimate partner violence. The interval for screening is not clear.
Treatment
Once intimate partner violence among women is detected, many approaches are available to help these women. For example, one trial was set up to test the effectiveness of a mentoring support group vs. usual care. All women who entered this trial had discussed intimate partner violence with their primary care physician. After the intervention program, the women who were in the intervention group had significantly reduced scores of abuse as opposed to the comparison group. Another example is a study of pregnant women who reported abuse, who were then randomized to a counseling intervention vs. usual care. Women in the counseling group had decreased pregnancy coercion and were more likely to discontinue an unhealthy or unsafe relationship.
Approaches vary from counseling to social work interventions brought to peoples’ homes, information cards, referral to community services, and mentoring support services. It appears that varied interventions decrease recurrent abuse. There is no reported harm in screening for intimate partner violence. It is necessary for the primary care doctor to be aware of the laws specific to intimate partner violence reporting and privacy within the doctor’s specific region.
Elderly and vulnerable adults
In contrast to screening for intimate partner violence in women, there is a lack of evidence for abuse screening in elderly and vulnerable adult populations. There is a lack of evidence on the benefits of detection and, surprisingly, a lack of evidence on the benefits of early intervention. It is also possible that the harms of detecting abuse in this group may be different, although the risk appears to be small. Some potential harm includes shame, guilt, fear of retaliation, and abandonment by caretakers who have been accused of abuse.
While the evidence to support screening elderly and vulnerable adults is limited, state and local laws vary about the obligation and logistics of reporting elderly abuse. A main conclusion of the USPSTF is that more evidence-based research needs to be done for the population of elderly and vulnerable adults.
Bottom line
Intimate partner violence is common, affecting a quarter of all adults at some point in their life. The mental and physical effects of intimate partner violence can be severe and long-lasting. Screening for intimate partner violence is effective, and effective interventions can be carried out to help women who are victims of intimate partner violence. The USPSTF recommends routine screening of women of reproductive age for intimate partner violence. The data on screening for abuse in the elderly and vulnerable adults is insufficient for the USPSTF to make a recommendation for or against screening.
Reference
• Screening for Intimate Partner Violence and Abuse of Elderly and Vulnerable Adults: U.S. Preventive Services Task Force Recommendation Statement. (Ann. Intern. Med. 2013:158;478-86).
Ms. Skolnik attends Drexel University, Philadelphia, and is a research assistant at the Children’s Hospital of Pennsylvania. Dr. Clouse is an associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital.
*Correction 1/23/14: A previous version of this article misstated the name of the American College of Obstetricians and Gynecologists. This version has been updated.
The U.S. Preventive Services Task Force has released updated recommendations regarding screening for intimate partner violence and abuse of elderly and vulnerable adults. While their previous recommendations in 2004 gave intimate partner violence screening an "I" recommendation, meaning that the evidence was inconclusive regarding the balance of benefits and intimate partner violence harms, the current recommendation has been upgraded to a "B" recommendation, meaning there is moderate certainty that there is a net benefit from screening. This puts the USPSTF recommendation in alignment with those of most other groups, including the American Medical Association and the *American College of Obstetricians and Gynecologists.
Forms of abuse
The recommendations regarding intimate partner violence in these guidelines refer to physical, sexual, or psychological abuse of women of reproductive age by a current or former partner or spouse. The issue of intimate partner violence is important because research shows that approximately 31% of women and 26% of men have experienced intimate partner violence within their lifetime, and that intimate partner violence is usually undetected. It is also estimated that these numbers are likely to be low because of underreporting. In one large study, the 1-year incidence of abuse was 8% within the last year and 15% within the last 5 years. Approximately 1.5%-5% of pregnant women report being abused. Among older and vulnerable adults, the rate of physical, psychological, or sexual abuse; neglect; or financial exploitation is estimated to be between 2% and 10%.
Intimate partner violence has important and long-lasting effects on victims. Harmful effects include immediate injuries resulting from direct trauma as well as long-term physical and mental health consequences. Long-term physical consequences include sexually transmitted diseases, unintended pregnancy, and worse pregnancy outcomes, as well as higher rates of chronic pain, gastrointestinal disorders, migraine headaches, and disability. Long-term mental health consequences include depression, post-traumatic stress disorder, anxiety disorders, substance abuse, and a higher rate of suicide.
Screening of women
Intimate partner violence in women can be detected with a high level of certainty. There are specific factors that can influence the chances that an individual is at risk for intimate partner violence and can alert clinicians to have increased vigilance for abuse. These risk factors have four categories. The first category is individual, focusing on an individual’s self-esteem. The second is relationship, which focuses on marriage conflict and stability within relationships. Third is community, which is looking at socioeconomic background. Fourth are the societal factors of traditional gender roles.
Many screening instruments exist that have been carefully studied. For instance, the HITS instrument, available in English and Spanish, is a four-item questionnaire that asks about being hurt, insulted, screamed at, or threatened. In one study, it had a sensitivity of 86% and a specificity of 99% for detecting intimate partner violence. The interval for screening is not clear.
Treatment
Once intimate partner violence among women is detected, many approaches are available to help these women. For example, one trial was set up to test the effectiveness of a mentoring support group vs. usual care. All women who entered this trial had discussed intimate partner violence with their primary care physician. After the intervention program, the women who were in the intervention group had significantly reduced scores of abuse as opposed to the comparison group. Another example is a study of pregnant women who reported abuse, who were then randomized to a counseling intervention vs. usual care. Women in the counseling group had decreased pregnancy coercion and were more likely to discontinue an unhealthy or unsafe relationship.
Approaches vary from counseling to social work interventions brought to peoples’ homes, information cards, referral to community services, and mentoring support services. It appears that varied interventions decrease recurrent abuse. There is no reported harm in screening for intimate partner violence. It is necessary for the primary care doctor to be aware of the laws specific to intimate partner violence reporting and privacy within the doctor’s specific region.
Elderly and vulnerable adults
In contrast to screening for intimate partner violence in women, there is a lack of evidence for abuse screening in elderly and vulnerable adult populations. There is a lack of evidence on the benefits of detection and, surprisingly, a lack of evidence on the benefits of early intervention. It is also possible that the harms of detecting abuse in this group may be different, although the risk appears to be small. Some potential harm includes shame, guilt, fear of retaliation, and abandonment by caretakers who have been accused of abuse.
While the evidence to support screening elderly and vulnerable adults is limited, state and local laws vary about the obligation and logistics of reporting elderly abuse. A main conclusion of the USPSTF is that more evidence-based research needs to be done for the population of elderly and vulnerable adults.
Bottom line
Intimate partner violence is common, affecting a quarter of all adults at some point in their life. The mental and physical effects of intimate partner violence can be severe and long-lasting. Screening for intimate partner violence is effective, and effective interventions can be carried out to help women who are victims of intimate partner violence. The USPSTF recommends routine screening of women of reproductive age for intimate partner violence. The data on screening for abuse in the elderly and vulnerable adults is insufficient for the USPSTF to make a recommendation for or against screening.
Reference
• Screening for Intimate Partner Violence and Abuse of Elderly and Vulnerable Adults: U.S. Preventive Services Task Force Recommendation Statement. (Ann. Intern. Med. 2013:158;478-86).
Ms. Skolnik attends Drexel University, Philadelphia, and is a research assistant at the Children’s Hospital of Pennsylvania. Dr. Clouse is an associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital.
*Correction 1/23/14: A previous version of this article misstated the name of the American College of Obstetricians and Gynecologists. This version has been updated.
'JNC 8' guideline follows convoluted endgame
The federally funded program to produce a set of U.S. guidelines for hypertension management, a process more than 5 years in the making, came to an unusual end on December 18 when the members of what had already become the officially-disbanded JNC 8 panel published their conclusions and guideline.
No longer recognized or supported by the National Heart Lung and Blood Institute (NHLBI), the Federal agency that had organized the Eighth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8) panel in 2008, and unwilling to work with potential collaborating groups like the American Heart Association (AHA), the American College of Cardiology (ACC), or the American Society of Hypertension (ASH), the 17-person group that wound up identifying themselves as the “panel members appointed to the Eighth Joint National Committee (JNC 8).”
Call them JNC Ain’t.
The U.S. hypertension guidelines began veering off on an unexpected course last June, when Dr. Gary H. Gibbons, NHLBI director, announced that the agency was withdrawing from issuing guidelines itself and would instead collaborate with “partner organizations.”
In August, Dr. Gibbons, said that the AHA and ACC had reached an agreement with the agency to “spearhead” development of three sets of practice guidelines, for hypertension, cholesterol, and obesity. This agreement led to the release in November of the cholesterol and obesity guidelines under the auspices of the AHA and ACC, but instead of also releasing hypertension guidelines, the AHA and ACC as well as the NHLBI said that the process had fallen through and failed to produce guidelines.
According to Dr. Paul A. James, co-chair of the former JNC 8 panel and professor of family medicine at the University of Iowa in Iowa City, that’s because the panel members decided they weren’t comfortable with “the idea of shopping our guideline around prior to publication and getting an endorsement.” Now that the panel’s conclusions have been published “we hope to get active public review of our work; we invite people to analyze our process, and hopefully organizations will endorse our findings,” he said in an interview. “Our belief is that the approach we took, the transparent nature of our guideline development, and our release of it through JAMA will increase the credibility of our work.”
But others said that the panel’s break with the NHLBI and its inability to partner with any organization will inevitably affect how people view these recommendations, especially because parts are also clinically controversial.
“There was clear controversy when this guideline was circulated” while under review, said Dr. John M. Flack, professor and chief of medicine at Wayne State University in Detroit. “The biggest problem this committee has is that many experts with a very significant stake in the recommendations were excluded from the process of generating the guideline. That limits buy-in from key opinion leaders, which will be needed for the uptake of this guideline into clinical practice,” he said in an interview.
“Unlike the previous JNC reports, this one will be seen as interesting, but not as persuasive,” said Dr. Michael A. Weber, professor of medicine at the State University of New York Downstate Medical Center in Brooklyn. “I believe the AHA, ACC, and ASH had hoped to endorse these guidelines, but that wasn’t possible.”
ASH leaders had discussions with the JNC 8 panel last summer, but the two groups could not reach an agreement on how to use the panel’s work for management recommendations, said Dr. William B. White, ASH president and chief of hypertension and clinical pharmacology at the University of Connecticut in Farmington.
What ASH has since agreed to do is join with the AHA and ACC to produce evidence-based hypertension guidelines using NHLBI materials, Dr. White said in an interview. The planned guidelines will “use some of the evidence derived by the NHLBI’s methodology, but adding to it other clinical issues,” including blood pressure measurement. These groups also hope the guidelines development will receive participation from a primary-care society such as the American College of Physicians, he said.
“The ACC/AHA Task Force on Practice Guidelines has begun the process of developing the collaborative model to update the national hypertensive guidelines in partnership with the NHLBI, which will provide an updated systematic review informed by the relevant critical clinical questions. We are seeking appropriate partners to begin this work in early 2014. The writing group will draft recommendations, followed by a peer and stakeholder review process. Once the review process is complete the ACC/AHA and partnering organizations will publish the guidelines in 2015 for clinicians to follow as the national standard for hypertension prevention and treatment,” said a spokeswoman for the American College of Cardiology in a statement released on December 18.
Leaders from the AHA and ACC said that once it became clear several weeks ago that they would not be able to collaborate with the JNC 8 panel, they felt compelled to immediately develop some form of updated guidance on hypertensive management. That led to an AHA-ACC Science Advisory (J. Am. Coll. Card. 2013;doi:10.1016/j.jacc.2013.11.007) released on Nov. 15 in collaboration with the Centers for Disease Control and Prevention that endorsed the use of treatment algorithms when managing patients with hypertension.
“Because the JNC 8 panel chose not to be part of the AHA-ACC structure, we felt we needed to go forward to make sure that we had guidance that reflected the evidence,” said Dr. Kim A. Williams Sr., professor and head of cardiology at Rush University in Chicago, vice president of the ACC, and a member of the group that wrote the advisory. “We felt the need to have risk covered as best we could, and have some hypertension guidance out there, even if it is not a guideline,” he said in an interview.
“We felt that after the enormous progress forward with the other four guidelines” released on Nov. 12 by the AHA and ACC (Circulation 2013 [doi: 10.1161/01.cir.0000437738.63853.7a; doi: 10.1161/01.cir.0000437739.71477.ee; doi: 10.1161/01.cir.0000437740.48606.d1; doi: 10.1161/01.cir.0000437741.48606.98]) “there was some urgency” to provide guidance for hypertension too, said Dr. Mariell Jessup, professor and medical director of the Penn Heart and Vascular Center at the University of Pennsylvania in Philadelphia and president of the AHA, during a session on the new guidelines at the AHA Scientific Sessions in Dallas in November.
The potential this now presents for the AHA and ACC to produce unified U.S. guidelines for all aspects of cardiovascular disease risk, integrating the assessment and treatment of hypertension, cholesterol, and obesity, is a positive development, said Dr. Eric D. Peterson, professor of medicine at Duke University in Durham, N.C. He was also hopeful that this new collaboration will draw in groups like ASH and the American College of Physicians to represent the interests of subspecialists and primary-care physicians. “Ideally you want consensus on where you’re trying to get blood pressure” that cuts across all strata of U.S. medicine, he said.
Dr. James, Dr. White, Dr. Jessup, Dr. Williams and Dr. Peterson said that they had no disclosures. Dr. Flack said that he has been a consultant to Novartis, Medtronic, and Back Beat Hypertension and received funding from Novartis and Medtronic. Dr. Weber said that he has been a consultant to Novartis, Takeda, and Forest.
[email protected]
On Twitter @mitchelzoler
**UPDATED Jan. 4, 2014
The federally funded program to produce a set of U.S. guidelines for hypertension management, a process more than 5 years in the making, came to an unusual end on December 18 when the members of what had already become the officially-disbanded JNC 8 panel published their conclusions and guideline.
No longer recognized or supported by the National Heart Lung and Blood Institute (NHLBI), the Federal agency that had organized the Eighth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8) panel in 2008, and unwilling to work with potential collaborating groups like the American Heart Association (AHA), the American College of Cardiology (ACC), or the American Society of Hypertension (ASH), the 17-person group that wound up identifying themselves as the “panel members appointed to the Eighth Joint National Committee (JNC 8).”
Call them JNC Ain’t.
The U.S. hypertension guidelines began veering off on an unexpected course last June, when Dr. Gary H. Gibbons, NHLBI director, announced that the agency was withdrawing from issuing guidelines itself and would instead collaborate with “partner organizations.”
In August, Dr. Gibbons, said that the AHA and ACC had reached an agreement with the agency to “spearhead” development of three sets of practice guidelines, for hypertension, cholesterol, and obesity. This agreement led to the release in November of the cholesterol and obesity guidelines under the auspices of the AHA and ACC, but instead of also releasing hypertension guidelines, the AHA and ACC as well as the NHLBI said that the process had fallen through and failed to produce guidelines.
According to Dr. Paul A. James, co-chair of the former JNC 8 panel and professor of family medicine at the University of Iowa in Iowa City, that’s because the panel members decided they weren’t comfortable with “the idea of shopping our guideline around prior to publication and getting an endorsement.” Now that the panel’s conclusions have been published “we hope to get active public review of our work; we invite people to analyze our process, and hopefully organizations will endorse our findings,” he said in an interview. “Our belief is that the approach we took, the transparent nature of our guideline development, and our release of it through JAMA will increase the credibility of our work.”
But others said that the panel’s break with the NHLBI and its inability to partner with any organization will inevitably affect how people view these recommendations, especially because parts are also clinically controversial.
“There was clear controversy when this guideline was circulated” while under review, said Dr. John M. Flack, professor and chief of medicine at Wayne State University in Detroit. “The biggest problem this committee has is that many experts with a very significant stake in the recommendations were excluded from the process of generating the guideline. That limits buy-in from key opinion leaders, which will be needed for the uptake of this guideline into clinical practice,” he said in an interview.
“Unlike the previous JNC reports, this one will be seen as interesting, but not as persuasive,” said Dr. Michael A. Weber, professor of medicine at the State University of New York Downstate Medical Center in Brooklyn. “I believe the AHA, ACC, and ASH had hoped to endorse these guidelines, but that wasn’t possible.”
ASH leaders had discussions with the JNC 8 panel last summer, but the two groups could not reach an agreement on how to use the panel’s work for management recommendations, said Dr. William B. White, ASH president and chief of hypertension and clinical pharmacology at the University of Connecticut in Farmington.
What ASH has since agreed to do is join with the AHA and ACC to produce evidence-based hypertension guidelines using NHLBI materials, Dr. White said in an interview. The planned guidelines will “use some of the evidence derived by the NHLBI’s methodology, but adding to it other clinical issues,” including blood pressure measurement. These groups also hope the guidelines development will receive participation from a primary-care society such as the American College of Physicians, he said.
“The ACC/AHA Task Force on Practice Guidelines has begun the process of developing the collaborative model to update the national hypertensive guidelines in partnership with the NHLBI, which will provide an updated systematic review informed by the relevant critical clinical questions. We are seeking appropriate partners to begin this work in early 2014. The writing group will draft recommendations, followed by a peer and stakeholder review process. Once the review process is complete the ACC/AHA and partnering organizations will publish the guidelines in 2015 for clinicians to follow as the national standard for hypertension prevention and treatment,” said a spokeswoman for the American College of Cardiology in a statement released on December 18.
Leaders from the AHA and ACC said that once it became clear several weeks ago that they would not be able to collaborate with the JNC 8 panel, they felt compelled to immediately develop some form of updated guidance on hypertensive management. That led to an AHA-ACC Science Advisory (J. Am. Coll. Card. 2013;doi:10.1016/j.jacc.2013.11.007) released on Nov. 15 in collaboration with the Centers for Disease Control and Prevention that endorsed the use of treatment algorithms when managing patients with hypertension.
“Because the JNC 8 panel chose not to be part of the AHA-ACC structure, we felt we needed to go forward to make sure that we had guidance that reflected the evidence,” said Dr. Kim A. Williams Sr., professor and head of cardiology at Rush University in Chicago, vice president of the ACC, and a member of the group that wrote the advisory. “We felt the need to have risk covered as best we could, and have some hypertension guidance out there, even if it is not a guideline,” he said in an interview.
“We felt that after the enormous progress forward with the other four guidelines” released on Nov. 12 by the AHA and ACC (Circulation 2013 [doi: 10.1161/01.cir.0000437738.63853.7a; doi: 10.1161/01.cir.0000437739.71477.ee; doi: 10.1161/01.cir.0000437740.48606.d1; doi: 10.1161/01.cir.0000437741.48606.98]) “there was some urgency” to provide guidance for hypertension too, said Dr. Mariell Jessup, professor and medical director of the Penn Heart and Vascular Center at the University of Pennsylvania in Philadelphia and president of the AHA, during a session on the new guidelines at the AHA Scientific Sessions in Dallas in November.
The potential this now presents for the AHA and ACC to produce unified U.S. guidelines for all aspects of cardiovascular disease risk, integrating the assessment and treatment of hypertension, cholesterol, and obesity, is a positive development, said Dr. Eric D. Peterson, professor of medicine at Duke University in Durham, N.C. He was also hopeful that this new collaboration will draw in groups like ASH and the American College of Physicians to represent the interests of subspecialists and primary-care physicians. “Ideally you want consensus on where you’re trying to get blood pressure” that cuts across all strata of U.S. medicine, he said.
Dr. James, Dr. White, Dr. Jessup, Dr. Williams and Dr. Peterson said that they had no disclosures. Dr. Flack said that he has been a consultant to Novartis, Medtronic, and Back Beat Hypertension and received funding from Novartis and Medtronic. Dr. Weber said that he has been a consultant to Novartis, Takeda, and Forest.
[email protected]
On Twitter @mitchelzoler
**UPDATED Jan. 4, 2014
The federally funded program to produce a set of U.S. guidelines for hypertension management, a process more than 5 years in the making, came to an unusual end on December 18 when the members of what had already become the officially-disbanded JNC 8 panel published their conclusions and guideline.
No longer recognized or supported by the National Heart Lung and Blood Institute (NHLBI), the Federal agency that had organized the Eighth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8) panel in 2008, and unwilling to work with potential collaborating groups like the American Heart Association (AHA), the American College of Cardiology (ACC), or the American Society of Hypertension (ASH), the 17-person group that wound up identifying themselves as the “panel members appointed to the Eighth Joint National Committee (JNC 8).”
Call them JNC Ain’t.
The U.S. hypertension guidelines began veering off on an unexpected course last June, when Dr. Gary H. Gibbons, NHLBI director, announced that the agency was withdrawing from issuing guidelines itself and would instead collaborate with “partner organizations.”
In August, Dr. Gibbons, said that the AHA and ACC had reached an agreement with the agency to “spearhead” development of three sets of practice guidelines, for hypertension, cholesterol, and obesity. This agreement led to the release in November of the cholesterol and obesity guidelines under the auspices of the AHA and ACC, but instead of also releasing hypertension guidelines, the AHA and ACC as well as the NHLBI said that the process had fallen through and failed to produce guidelines.
According to Dr. Paul A. James, co-chair of the former JNC 8 panel and professor of family medicine at the University of Iowa in Iowa City, that’s because the panel members decided they weren’t comfortable with “the idea of shopping our guideline around prior to publication and getting an endorsement.” Now that the panel’s conclusions have been published “we hope to get active public review of our work; we invite people to analyze our process, and hopefully organizations will endorse our findings,” he said in an interview. “Our belief is that the approach we took, the transparent nature of our guideline development, and our release of it through JAMA will increase the credibility of our work.”
But others said that the panel’s break with the NHLBI and its inability to partner with any organization will inevitably affect how people view these recommendations, especially because parts are also clinically controversial.
“There was clear controversy when this guideline was circulated” while under review, said Dr. John M. Flack, professor and chief of medicine at Wayne State University in Detroit. “The biggest problem this committee has is that many experts with a very significant stake in the recommendations were excluded from the process of generating the guideline. That limits buy-in from key opinion leaders, which will be needed for the uptake of this guideline into clinical practice,” he said in an interview.
“Unlike the previous JNC reports, this one will be seen as interesting, but not as persuasive,” said Dr. Michael A. Weber, professor of medicine at the State University of New York Downstate Medical Center in Brooklyn. “I believe the AHA, ACC, and ASH had hoped to endorse these guidelines, but that wasn’t possible.”
ASH leaders had discussions with the JNC 8 panel last summer, but the two groups could not reach an agreement on how to use the panel’s work for management recommendations, said Dr. William B. White, ASH president and chief of hypertension and clinical pharmacology at the University of Connecticut in Farmington.
What ASH has since agreed to do is join with the AHA and ACC to produce evidence-based hypertension guidelines using NHLBI materials, Dr. White said in an interview. The planned guidelines will “use some of the evidence derived by the NHLBI’s methodology, but adding to it other clinical issues,” including blood pressure measurement. These groups also hope the guidelines development will receive participation from a primary-care society such as the American College of Physicians, he said.
“The ACC/AHA Task Force on Practice Guidelines has begun the process of developing the collaborative model to update the national hypertensive guidelines in partnership with the NHLBI, which will provide an updated systematic review informed by the relevant critical clinical questions. We are seeking appropriate partners to begin this work in early 2014. The writing group will draft recommendations, followed by a peer and stakeholder review process. Once the review process is complete the ACC/AHA and partnering organizations will publish the guidelines in 2015 for clinicians to follow as the national standard for hypertension prevention and treatment,” said a spokeswoman for the American College of Cardiology in a statement released on December 18.
Leaders from the AHA and ACC said that once it became clear several weeks ago that they would not be able to collaborate with the JNC 8 panel, they felt compelled to immediately develop some form of updated guidance on hypertensive management. That led to an AHA-ACC Science Advisory (J. Am. Coll. Card. 2013;doi:10.1016/j.jacc.2013.11.007) released on Nov. 15 in collaboration with the Centers for Disease Control and Prevention that endorsed the use of treatment algorithms when managing patients with hypertension.
“Because the JNC 8 panel chose not to be part of the AHA-ACC structure, we felt we needed to go forward to make sure that we had guidance that reflected the evidence,” said Dr. Kim A. Williams Sr., professor and head of cardiology at Rush University in Chicago, vice president of the ACC, and a member of the group that wrote the advisory. “We felt the need to have risk covered as best we could, and have some hypertension guidance out there, even if it is not a guideline,” he said in an interview.
“We felt that after the enormous progress forward with the other four guidelines” released on Nov. 12 by the AHA and ACC (Circulation 2013 [doi: 10.1161/01.cir.0000437738.63853.7a; doi: 10.1161/01.cir.0000437739.71477.ee; doi: 10.1161/01.cir.0000437740.48606.d1; doi: 10.1161/01.cir.0000437741.48606.98]) “there was some urgency” to provide guidance for hypertension too, said Dr. Mariell Jessup, professor and medical director of the Penn Heart and Vascular Center at the University of Pennsylvania in Philadelphia and president of the AHA, during a session on the new guidelines at the AHA Scientific Sessions in Dallas in November.
The potential this now presents for the AHA and ACC to produce unified U.S. guidelines for all aspects of cardiovascular disease risk, integrating the assessment and treatment of hypertension, cholesterol, and obesity, is a positive development, said Dr. Eric D. Peterson, professor of medicine at Duke University in Durham, N.C. He was also hopeful that this new collaboration will draw in groups like ASH and the American College of Physicians to represent the interests of subspecialists and primary-care physicians. “Ideally you want consensus on where you’re trying to get blood pressure” that cuts across all strata of U.S. medicine, he said.
Dr. James, Dr. White, Dr. Jessup, Dr. Williams and Dr. Peterson said that they had no disclosures. Dr. Flack said that he has been a consultant to Novartis, Medtronic, and Back Beat Hypertension and received funding from Novartis and Medtronic. Dr. Weber said that he has been a consultant to Novartis, Takeda, and Forest.
[email protected]
On Twitter @mitchelzoler
**UPDATED Jan. 4, 2014
Consensus Recommendations From the American Acne & Rosacea Society on the Management of Rosacea, Part 3: A Status Report on Systemic Therapies
Evidence and expertise in writing medical guidelines
With timing that defies coincidence, the American Society of Hypertension (ASH) and International Society of Hypertension (ISH) posted on Dec. 17 new guidelines for hypertension diagnosis and treatment, and on Dec. 18 guidelines addressing the same topic were issued by the group of experts who had previously been called the Eighth Joint National Committee (JNC 8).
The big disagreement between the two was target systolic blood pressure (SBP) for hypertensive patients aged 60 or older. Guidelines from the former JNC 8 panel created an SBP target of less than 150 mm Hg, concluding that no high-quality evidence existed to justify treating these patients to a lower pressure. The ASH-ISH guidelines called for a target SBP of less than 140 mm Hg in patients aged 79 or younger, and they did not present any formal literature review to justify their choice. Their most clearly articulated reason for picking less than 140/90 mm Hg? "Guidelines tend to use 140/90 mm Hg for all adults (up to 80 years)."
The two guidelines differed just as starkly in their approach. In fact, one interpretation is that the difference in approach largely drove the difference in systolic targets. The former JNC 8 panel said that they focused on high-quality evidence from randomized clinical trials. They spell out their dissection of the evidence in a 300-page supplement to their JAMA paper that includes hundreds of references. The ASH-ISH guideline document has no evidence review, and includes a taut 25 citations as "suggested reading."
"Our group was very evidence based," said Dr. Paul A. James, a family medicine professor at the University of Iowa, Iowa City, and cochair of the former JNC 8 panel.
"To my mind, the purpose of a guideline is for a group of experts to go as far as they can guided by the evidence, and then to use their experience and judgment to make recommendations in the best interests of patients," said Dr. Michael A. Weber, professor of medicine at SUNY Downstate Medical Center, New York, and chair of the ASH-ISH guideline panel.
Was the former JNC 8 panel consistently objective in drawing conclusions from the evidence, or lack of evidence? An editorial that accompanied the former JNC 8 panel’s report noted, "In older populations the majority of the panel interpreted the lack of definitive benefit from RCTs (randomized controlled trials) as grounds to raise the SBP treatment goal recommendation to 150 mm Hg; however, for patients younger than 60 years, the paucity of any trial evidence provided no reason for the panel to change the existing treatment goal at 140 mm Hg."
As Dr. John M. Flack, chief of medicine at Wayne State University in Detroit, told me: "The committee was selective in what they considered could be justified."
"It’s astounding that we don’t have the evidence to say what the right treatment thresholds are even though hypertension is the No. 1 modifiable risk factor" for cardiovascular disease, observed Dr. Eric D. Peterson, the Duke University cardiologist who was lead author on the editorial.
Once concluding that not enough evidence existed to pinpoint a treatment target, the former JNC 8 panel still needed to choose a target. In their JAMA paper they acknowledged the panel’s minority view: "Some members recommended continuing the JNC 7 SBP goal of lower than 140 mm Hg for individuals older than 60 years based on expert opinion" and because "the evidence was insufficient to raise the SBP target from lower than 140 mm Hg to lower than 150 mm Hg in high-risk groups."
But a majority opted for a more controversial target instead.
On Twitter @mitchelzoler
With timing that defies coincidence, the American Society of Hypertension (ASH) and International Society of Hypertension (ISH) posted on Dec. 17 new guidelines for hypertension diagnosis and treatment, and on Dec. 18 guidelines addressing the same topic were issued by the group of experts who had previously been called the Eighth Joint National Committee (JNC 8).
The big disagreement between the two was target systolic blood pressure (SBP) for hypertensive patients aged 60 or older. Guidelines from the former JNC 8 panel created an SBP target of less than 150 mm Hg, concluding that no high-quality evidence existed to justify treating these patients to a lower pressure. The ASH-ISH guidelines called for a target SBP of less than 140 mm Hg in patients aged 79 or younger, and they did not present any formal literature review to justify their choice. Their most clearly articulated reason for picking less than 140/90 mm Hg? "Guidelines tend to use 140/90 mm Hg for all adults (up to 80 years)."
The two guidelines differed just as starkly in their approach. In fact, one interpretation is that the difference in approach largely drove the difference in systolic targets. The former JNC 8 panel said that they focused on high-quality evidence from randomized clinical trials. They spell out their dissection of the evidence in a 300-page supplement to their JAMA paper that includes hundreds of references. The ASH-ISH guideline document has no evidence review, and includes a taut 25 citations as "suggested reading."
"Our group was very evidence based," said Dr. Paul A. James, a family medicine professor at the University of Iowa, Iowa City, and cochair of the former JNC 8 panel.
"To my mind, the purpose of a guideline is for a group of experts to go as far as they can guided by the evidence, and then to use their experience and judgment to make recommendations in the best interests of patients," said Dr. Michael A. Weber, professor of medicine at SUNY Downstate Medical Center, New York, and chair of the ASH-ISH guideline panel.
Was the former JNC 8 panel consistently objective in drawing conclusions from the evidence, or lack of evidence? An editorial that accompanied the former JNC 8 panel’s report noted, "In older populations the majority of the panel interpreted the lack of definitive benefit from RCTs (randomized controlled trials) as grounds to raise the SBP treatment goal recommendation to 150 mm Hg; however, for patients younger than 60 years, the paucity of any trial evidence provided no reason for the panel to change the existing treatment goal at 140 mm Hg."
As Dr. John M. Flack, chief of medicine at Wayne State University in Detroit, told me: "The committee was selective in what they considered could be justified."
"It’s astounding that we don’t have the evidence to say what the right treatment thresholds are even though hypertension is the No. 1 modifiable risk factor" for cardiovascular disease, observed Dr. Eric D. Peterson, the Duke University cardiologist who was lead author on the editorial.
Once concluding that not enough evidence existed to pinpoint a treatment target, the former JNC 8 panel still needed to choose a target. In their JAMA paper they acknowledged the panel’s minority view: "Some members recommended continuing the JNC 7 SBP goal of lower than 140 mm Hg for individuals older than 60 years based on expert opinion" and because "the evidence was insufficient to raise the SBP target from lower than 140 mm Hg to lower than 150 mm Hg in high-risk groups."
But a majority opted for a more controversial target instead.
On Twitter @mitchelzoler
With timing that defies coincidence, the American Society of Hypertension (ASH) and International Society of Hypertension (ISH) posted on Dec. 17 new guidelines for hypertension diagnosis and treatment, and on Dec. 18 guidelines addressing the same topic were issued by the group of experts who had previously been called the Eighth Joint National Committee (JNC 8).
The big disagreement between the two was target systolic blood pressure (SBP) for hypertensive patients aged 60 or older. Guidelines from the former JNC 8 panel created an SBP target of less than 150 mm Hg, concluding that no high-quality evidence existed to justify treating these patients to a lower pressure. The ASH-ISH guidelines called for a target SBP of less than 140 mm Hg in patients aged 79 or younger, and they did not present any formal literature review to justify their choice. Their most clearly articulated reason for picking less than 140/90 mm Hg? "Guidelines tend to use 140/90 mm Hg for all adults (up to 80 years)."
The two guidelines differed just as starkly in their approach. In fact, one interpretation is that the difference in approach largely drove the difference in systolic targets. The former JNC 8 panel said that they focused on high-quality evidence from randomized clinical trials. They spell out their dissection of the evidence in a 300-page supplement to their JAMA paper that includes hundreds of references. The ASH-ISH guideline document has no evidence review, and includes a taut 25 citations as "suggested reading."
"Our group was very evidence based," said Dr. Paul A. James, a family medicine professor at the University of Iowa, Iowa City, and cochair of the former JNC 8 panel.
"To my mind, the purpose of a guideline is for a group of experts to go as far as they can guided by the evidence, and then to use their experience and judgment to make recommendations in the best interests of patients," said Dr. Michael A. Weber, professor of medicine at SUNY Downstate Medical Center, New York, and chair of the ASH-ISH guideline panel.
Was the former JNC 8 panel consistently objective in drawing conclusions from the evidence, or lack of evidence? An editorial that accompanied the former JNC 8 panel’s report noted, "In older populations the majority of the panel interpreted the lack of definitive benefit from RCTs (randomized controlled trials) as grounds to raise the SBP treatment goal recommendation to 150 mm Hg; however, for patients younger than 60 years, the paucity of any trial evidence provided no reason for the panel to change the existing treatment goal at 140 mm Hg."
As Dr. John M. Flack, chief of medicine at Wayne State University in Detroit, told me: "The committee was selective in what they considered could be justified."
"It’s astounding that we don’t have the evidence to say what the right treatment thresholds are even though hypertension is the No. 1 modifiable risk factor" for cardiovascular disease, observed Dr. Eric D. Peterson, the Duke University cardiologist who was lead author on the editorial.
Once concluding that not enough evidence existed to pinpoint a treatment target, the former JNC 8 panel still needed to choose a target. In their JAMA paper they acknowledged the panel’s minority view: "Some members recommended continuing the JNC 7 SBP goal of lower than 140 mm Hg for individuals older than 60 years based on expert opinion" and because "the evidence was insufficient to raise the SBP target from lower than 140 mm Hg to lower than 150 mm Hg in high-risk groups."
But a majority opted for a more controversial target instead.
On Twitter @mitchelzoler
‘JNC 8’ relaxes elderly systolic target below 150 mm Hg
The group of experts who had constituted the JNC 8 panel, a team assembled in 2008 by the National Heart, Lung, and Blood Institute to update official U.S. hypertension management guidelines, set the target blood pressure for the general population aged 60 years or older to less than 150/90 mm Hg, a major break from long-standing practice to treat such patients to a target systolic pressure of less than 140 mm Hg.
This decision, which the panel contends was driven by lack of clear evidence for extra benefit from the below–140 mm Hg target, will surely prove controversial, along with the panel’s relaxing of target blood pressures for patients with diabetes or chronic kidney disease to less than 140/90 mm Hg (increased from 130/80 mm Hg in the prior, JNC 7 guidelines). That controversy would be a fitting final curtain for the Eighth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8), a project that courted controversy by running years longer than anticipated and then generating several plot twists during the final months leading up to Dec. 18, when the former JNC 8 panel published its hypertension-management guideline (JAMA 2013 Dec. 18 [doi:10.1001/jama.2013.284427]).
The new target of a systolic pressure of less than 150 mm Hg for hypertensive patients aged 60 or older without diabetes or chronic kidney disease "is definitely controversial," said Dr. Paul A. James, cochairman of the panel and professor of family medicine at the University of Iowa in Iowa City. "There is A-level evidence that getting blood pressure below 150 mm Hg results in improved outcomes that really matter, but we have no evidence at this time to support going lower," to less than 140 mm Hg. "The good news is that the panel is comfortable that we don’t do harm," by treating patients to less than 140 mm Hg. "But why put patients at increased risk for medication adverse events when we don’t have strong evidence of benefit?" he said in an interview.
He stressed that his group released their conclusions and guideline on their own, identifying themselves as "the panel members appointed to the Eighth Joint National Committee (JNC 8)." Leaders from the National Heart, Lung, and Blood Institute announced last June that the agency was pulling out of the business of issuing cardiovascular-disease management guidelines, and would instead fund evidence reviews and partner with other organizations to issue guidelines. The NHLBI arranged for its cholesterol, obesity, and lifestyle guidelines to be released through the American Heart Association and American College of Cardiology, but no similar arrangement worked out for the JNC 8 panel, which became the former panel when the NHLBI officially dissolved it by late summer.
The former JNC 8 panel applied "a very narrow interpretation" of the clinical evidence where the evidence is very incomplete, commented Dr. Michael A. Weber, professor of medicine at State University of New York, Brooklyn. "The purpose of guidelines is for a group of experts to be guided as far as they can by the evidence, and then use their judgment and experience to make recommendations that in the best interests of patients." He cited findings from the ACCOMPLISH, INVEST, and VALUE trials that show benefits from treating patients older than 60 years to a systolic pressure of less than 140 mm Hg, though he admitted that in each of these studies the findings did not come from primary, prespecified analyses.
Dr. Weber led a panel organized by the American Society of Hypertension and International Society of Hypertension that released its own set of hypertension diagnosis and management guidelines a day earlier, on Dec. 17 (J. Clin. Hypertension 2013 [doi:10.1111/ch.1223]). Where they overlap, the guidelines from ASH/ISH and from the former JNC 8 panel are mostly the same, with the systolic target for the general population aged 60-79 years being the main area of contention, Dr. Weber said. The ASH/ISH guideline set a systolic target of less than 150 mm Hg for the general hypertensive population aged 80 years or older.
The former-JNC 8 panel also qualified their 150 mm Hg–target by adding that if general population patients aged 60 years or older are on stable, well-tolerated antihypertensive treatment and have a systolic pressure of less than 140 mm Hg, changing treatment and aiming for a higher systolic pressure is not recommended.
The target of less than 150 mm Hg for these patients also had defenders. "They made a reasonable recommendation for the elderly based on the evidence," said Dr. John M. Flack, professor and chief of medicine at Wayne State University in Detroit. But he took the JNC 8 panel to task for relaxing the systolic and diastolic pressure targets for patients with either diabetes or chronic kidney disease from the prior target of less than 130/80 mm Hg to new targets of less than 140/90 mm Hg. "Relaxing blood pressure targets in high-risk groups when so much progress has been made over the last decade is going to be very controversial," he said in an interview. The new ASH-ISH hypertension guideline also set a blood pressure target of less than 140/90 mm Hg for patients with diabetes or chronic kidney disease.
The guideline from the former JNC 8 panel "will produce a lot of discussion, and the main target will be whether the 150 mm Hg target is right or not," commented Dr. Eric D. Peterson, professor of medicine at Duke University in Durham, N.C. In an editorial that accompanied the published guideline, Dr. Peterson and his associates also noted that the hypertension goals specified in authoritative guidelines had a magnified importance these days because they often are incorporated into "performance measures" to which physicians can be often held rigidly accountable.(JAMA 2013 Dec. 18 [doi:10.1001/jama.2013.284430]).
"I chair the ACC/AHA Task Force on Performance Measures, and we will be in a bind because the current performance measures call for a blood pressure target of less than 140/90 mm Hg," he said in an interview. The ACC/AHA task force is one of the main contributors of performance measures for cardiovascular disease to the U.S. clearing house for performance measures, the National Quality Forum. "The Task Force will need to respond to this guideline in some way," he said, but the Task Force takes into account the range of current guidelines that exist and their backup evidence, so how it will decide on this issue remains uncertain.
"My concern is not so much with the number they came up with as with how it will be used by physicians in the community," Dr. Peterson said. On one hand, you don’t want physicians to get carried away and feel they need to treat all their patients to below some magical number." As he pointed out in his editorial, the counterbalancing problem is that there is always a gap between the hypertension treatment goals and what is often achieved in practice. If that relationship remains and the accepted goal for patients aged 60-79 years becomes less than 150 mm Hg, then many U.S. patients in this group may end up treated but with systolic pressures above 150 mm Hg.
Dr. James and Dr. Peterson said that they had no disclosures. Dr. Weber said that he has been a consultant to Novartis, Takeda, and Forest. Dr. Flack said that he has been a consultant to Novartis, Medtronic, and Back Beat Hypertension and received funding from Novartis and Medtronic.
On Twitter @mitchelzoler
The group of experts who had constituted the JNC 8 panel, a team assembled in 2008 by the National Heart, Lung, and Blood Institute to update official U.S. hypertension management guidelines, set the target blood pressure for the general population aged 60 years or older to less than 150/90 mm Hg, a major break from long-standing practice to treat such patients to a target systolic pressure of less than 140 mm Hg.
This decision, which the panel contends was driven by lack of clear evidence for extra benefit from the below–140 mm Hg target, will surely prove controversial, along with the panel’s relaxing of target blood pressures for patients with diabetes or chronic kidney disease to less than 140/90 mm Hg (increased from 130/80 mm Hg in the prior, JNC 7 guidelines). That controversy would be a fitting final curtain for the Eighth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8), a project that courted controversy by running years longer than anticipated and then generating several plot twists during the final months leading up to Dec. 18, when the former JNC 8 panel published its hypertension-management guideline (JAMA 2013 Dec. 18 [doi:10.1001/jama.2013.284427]).
The new target of a systolic pressure of less than 150 mm Hg for hypertensive patients aged 60 or older without diabetes or chronic kidney disease "is definitely controversial," said Dr. Paul A. James, cochairman of the panel and professor of family medicine at the University of Iowa in Iowa City. "There is A-level evidence that getting blood pressure below 150 mm Hg results in improved outcomes that really matter, but we have no evidence at this time to support going lower," to less than 140 mm Hg. "The good news is that the panel is comfortable that we don’t do harm," by treating patients to less than 140 mm Hg. "But why put patients at increased risk for medication adverse events when we don’t have strong evidence of benefit?" he said in an interview.
He stressed that his group released their conclusions and guideline on their own, identifying themselves as "the panel members appointed to the Eighth Joint National Committee (JNC 8)." Leaders from the National Heart, Lung, and Blood Institute announced last June that the agency was pulling out of the business of issuing cardiovascular-disease management guidelines, and would instead fund evidence reviews and partner with other organizations to issue guidelines. The NHLBI arranged for its cholesterol, obesity, and lifestyle guidelines to be released through the American Heart Association and American College of Cardiology, but no similar arrangement worked out for the JNC 8 panel, which became the former panel when the NHLBI officially dissolved it by late summer.
The former JNC 8 panel applied "a very narrow interpretation" of the clinical evidence where the evidence is very incomplete, commented Dr. Michael A. Weber, professor of medicine at State University of New York, Brooklyn. "The purpose of guidelines is for a group of experts to be guided as far as they can by the evidence, and then use their judgment and experience to make recommendations that in the best interests of patients." He cited findings from the ACCOMPLISH, INVEST, and VALUE trials that show benefits from treating patients older than 60 years to a systolic pressure of less than 140 mm Hg, though he admitted that in each of these studies the findings did not come from primary, prespecified analyses.
Dr. Weber led a panel organized by the American Society of Hypertension and International Society of Hypertension that released its own set of hypertension diagnosis and management guidelines a day earlier, on Dec. 17 (J. Clin. Hypertension 2013 [doi:10.1111/ch.1223]). Where they overlap, the guidelines from ASH/ISH and from the former JNC 8 panel are mostly the same, with the systolic target for the general population aged 60-79 years being the main area of contention, Dr. Weber said. The ASH/ISH guideline set a systolic target of less than 150 mm Hg for the general hypertensive population aged 80 years or older.
The former-JNC 8 panel also qualified their 150 mm Hg–target by adding that if general population patients aged 60 years or older are on stable, well-tolerated antihypertensive treatment and have a systolic pressure of less than 140 mm Hg, changing treatment and aiming for a higher systolic pressure is not recommended.
The target of less than 150 mm Hg for these patients also had defenders. "They made a reasonable recommendation for the elderly based on the evidence," said Dr. John M. Flack, professor and chief of medicine at Wayne State University in Detroit. But he took the JNC 8 panel to task for relaxing the systolic and diastolic pressure targets for patients with either diabetes or chronic kidney disease from the prior target of less than 130/80 mm Hg to new targets of less than 140/90 mm Hg. "Relaxing blood pressure targets in high-risk groups when so much progress has been made over the last decade is going to be very controversial," he said in an interview. The new ASH-ISH hypertension guideline also set a blood pressure target of less than 140/90 mm Hg for patients with diabetes or chronic kidney disease.
The guideline from the former JNC 8 panel "will produce a lot of discussion, and the main target will be whether the 150 mm Hg target is right or not," commented Dr. Eric D. Peterson, professor of medicine at Duke University in Durham, N.C. In an editorial that accompanied the published guideline, Dr. Peterson and his associates also noted that the hypertension goals specified in authoritative guidelines had a magnified importance these days because they often are incorporated into "performance measures" to which physicians can be often held rigidly accountable.(JAMA 2013 Dec. 18 [doi:10.1001/jama.2013.284430]).
"I chair the ACC/AHA Task Force on Performance Measures, and we will be in a bind because the current performance measures call for a blood pressure target of less than 140/90 mm Hg," he said in an interview. The ACC/AHA task force is one of the main contributors of performance measures for cardiovascular disease to the U.S. clearing house for performance measures, the National Quality Forum. "The Task Force will need to respond to this guideline in some way," he said, but the Task Force takes into account the range of current guidelines that exist and their backup evidence, so how it will decide on this issue remains uncertain.
"My concern is not so much with the number they came up with as with how it will be used by physicians in the community," Dr. Peterson said. On one hand, you don’t want physicians to get carried away and feel they need to treat all their patients to below some magical number." As he pointed out in his editorial, the counterbalancing problem is that there is always a gap between the hypertension treatment goals and what is often achieved in practice. If that relationship remains and the accepted goal for patients aged 60-79 years becomes less than 150 mm Hg, then many U.S. patients in this group may end up treated but with systolic pressures above 150 mm Hg.
Dr. James and Dr. Peterson said that they had no disclosures. Dr. Weber said that he has been a consultant to Novartis, Takeda, and Forest. Dr. Flack said that he has been a consultant to Novartis, Medtronic, and Back Beat Hypertension and received funding from Novartis and Medtronic.
On Twitter @mitchelzoler
The group of experts who had constituted the JNC 8 panel, a team assembled in 2008 by the National Heart, Lung, and Blood Institute to update official U.S. hypertension management guidelines, set the target blood pressure for the general population aged 60 years or older to less than 150/90 mm Hg, a major break from long-standing practice to treat such patients to a target systolic pressure of less than 140 mm Hg.
This decision, which the panel contends was driven by lack of clear evidence for extra benefit from the below–140 mm Hg target, will surely prove controversial, along with the panel’s relaxing of target blood pressures for patients with diabetes or chronic kidney disease to less than 140/90 mm Hg (increased from 130/80 mm Hg in the prior, JNC 7 guidelines). That controversy would be a fitting final curtain for the Eighth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8), a project that courted controversy by running years longer than anticipated and then generating several plot twists during the final months leading up to Dec. 18, when the former JNC 8 panel published its hypertension-management guideline (JAMA 2013 Dec. 18 [doi:10.1001/jama.2013.284427]).
The new target of a systolic pressure of less than 150 mm Hg for hypertensive patients aged 60 or older without diabetes or chronic kidney disease "is definitely controversial," said Dr. Paul A. James, cochairman of the panel and professor of family medicine at the University of Iowa in Iowa City. "There is A-level evidence that getting blood pressure below 150 mm Hg results in improved outcomes that really matter, but we have no evidence at this time to support going lower," to less than 140 mm Hg. "The good news is that the panel is comfortable that we don’t do harm," by treating patients to less than 140 mm Hg. "But why put patients at increased risk for medication adverse events when we don’t have strong evidence of benefit?" he said in an interview.
He stressed that his group released their conclusions and guideline on their own, identifying themselves as "the panel members appointed to the Eighth Joint National Committee (JNC 8)." Leaders from the National Heart, Lung, and Blood Institute announced last June that the agency was pulling out of the business of issuing cardiovascular-disease management guidelines, and would instead fund evidence reviews and partner with other organizations to issue guidelines. The NHLBI arranged for its cholesterol, obesity, and lifestyle guidelines to be released through the American Heart Association and American College of Cardiology, but no similar arrangement worked out for the JNC 8 panel, which became the former panel when the NHLBI officially dissolved it by late summer.
The former JNC 8 panel applied "a very narrow interpretation" of the clinical evidence where the evidence is very incomplete, commented Dr. Michael A. Weber, professor of medicine at State University of New York, Brooklyn. "The purpose of guidelines is for a group of experts to be guided as far as they can by the evidence, and then use their judgment and experience to make recommendations that in the best interests of patients." He cited findings from the ACCOMPLISH, INVEST, and VALUE trials that show benefits from treating patients older than 60 years to a systolic pressure of less than 140 mm Hg, though he admitted that in each of these studies the findings did not come from primary, prespecified analyses.
Dr. Weber led a panel organized by the American Society of Hypertension and International Society of Hypertension that released its own set of hypertension diagnosis and management guidelines a day earlier, on Dec. 17 (J. Clin. Hypertension 2013 [doi:10.1111/ch.1223]). Where they overlap, the guidelines from ASH/ISH and from the former JNC 8 panel are mostly the same, with the systolic target for the general population aged 60-79 years being the main area of contention, Dr. Weber said. The ASH/ISH guideline set a systolic target of less than 150 mm Hg for the general hypertensive population aged 80 years or older.
The former-JNC 8 panel also qualified their 150 mm Hg–target by adding that if general population patients aged 60 years or older are on stable, well-tolerated antihypertensive treatment and have a systolic pressure of less than 140 mm Hg, changing treatment and aiming for a higher systolic pressure is not recommended.
The target of less than 150 mm Hg for these patients also had defenders. "They made a reasonable recommendation for the elderly based on the evidence," said Dr. John M. Flack, professor and chief of medicine at Wayne State University in Detroit. But he took the JNC 8 panel to task for relaxing the systolic and diastolic pressure targets for patients with either diabetes or chronic kidney disease from the prior target of less than 130/80 mm Hg to new targets of less than 140/90 mm Hg. "Relaxing blood pressure targets in high-risk groups when so much progress has been made over the last decade is going to be very controversial," he said in an interview. The new ASH-ISH hypertension guideline also set a blood pressure target of less than 140/90 mm Hg for patients with diabetes or chronic kidney disease.
The guideline from the former JNC 8 panel "will produce a lot of discussion, and the main target will be whether the 150 mm Hg target is right or not," commented Dr. Eric D. Peterson, professor of medicine at Duke University in Durham, N.C. In an editorial that accompanied the published guideline, Dr. Peterson and his associates also noted that the hypertension goals specified in authoritative guidelines had a magnified importance these days because they often are incorporated into "performance measures" to which physicians can be often held rigidly accountable.(JAMA 2013 Dec. 18 [doi:10.1001/jama.2013.284430]).
"I chair the ACC/AHA Task Force on Performance Measures, and we will be in a bind because the current performance measures call for a blood pressure target of less than 140/90 mm Hg," he said in an interview. The ACC/AHA task force is one of the main contributors of performance measures for cardiovascular disease to the U.S. clearing house for performance measures, the National Quality Forum. "The Task Force will need to respond to this guideline in some way," he said, but the Task Force takes into account the range of current guidelines that exist and their backup evidence, so how it will decide on this issue remains uncertain.
"My concern is not so much with the number they came up with as with how it will be used by physicians in the community," Dr. Peterson said. On one hand, you don’t want physicians to get carried away and feel they need to treat all their patients to below some magical number." As he pointed out in his editorial, the counterbalancing problem is that there is always a gap between the hypertension treatment goals and what is often achieved in practice. If that relationship remains and the accepted goal for patients aged 60-79 years becomes less than 150 mm Hg, then many U.S. patients in this group may end up treated but with systolic pressures above 150 mm Hg.
Dr. James and Dr. Peterson said that they had no disclosures. Dr. Weber said that he has been a consultant to Novartis, Takeda, and Forest. Dr. Flack said that he has been a consultant to Novartis, Medtronic, and Back Beat Hypertension and received funding from Novartis and Medtronic.
On Twitter @mitchelzoler
FROM JAMA
Consensus Recommendations From the American Acne & Rosacea Society on the Management of Rosacea, Part 2: A Status Report on Topical Agents
Consensus Recommendations From the American Acne & Rosacea Society on the Management of Rosacea, Part 1: A Status Report on the Disease State, General Measures, and Adjunctive Skin Care
Test your knowledge on consensus recommendations for rosacea with MD-IQ: the medical intelligence quiz. Click here to answer 5 questions.
NHLBI hands off hypertension guidelines to ACC, AHA
The two U.S. groups most active in issuing guidelines and recommendations for cardiovascular disease diagnosis and management, the American College of Cardiology and American Heart Association, received a surprise in June when the National Heart, Lung, and Blood Institute suddenly announced that it would shift to these and other "partner organizations" primary responsibility for the next updates of U.S. hypertension guidelines, national cholesterol-management guidelines, and the other cardiovascular disease–related management recommendations that the institute has had in the works.
The NHLBI launched "a collaborative relationship with the ACC, AHA, and other organizations because they said they are not in a position to endorse guidelines, they must be endorsed by other organizations," said Dr. Sidney C. Smith Jr., professor of medicine at the University of North Carolina in Chapel Hill. Dr. Smith is a member of the panel that’s been writing the Eighth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8), and has been active for a long time in the ACC and AHA guidelines-development process.
On June 19, Dr. Gary H. Gibbons, NHLBI director, and his associates announced that effective immediately the institute was getting out of the guidelines-issuing business (Circulation 2013; doi: 10.1161/CIRCULATIONAHA.113.004587).
"Just over the past couple of months we began to look at how this will be done. Everyone wants the process to move quickly. How quickly can these organizations put it together? That’s the limiting factor right now," Dr. Smith said in an interview in early September.
While the ACC and AHA have on record some 20 sets of practice guidelines that cover most facets of cardiology, their list omits areas that the NHLBI covered in the past, notably hypertension and hypercholesterolemia assessment and management.
"The ACC and AHA guideline process is very expensive, and we wouldn’t dream of duplicating something when people you trust were commissioned by someone else [NHLBI] to do the work," said Dr. Kim Allan Williams Sr. of Wayne State University, Detroit. Dr. Williams will take the position of professor of medicine and chief of cardiovascular services at Rush University Medical Center in Chicago on Nov. 1. He serves as vice-president of the ACC. "We have all been under the impression that JNC 8 was being put together and getting published soon," he said in an interview.
Dr. Williams stressed that he and other ACC officials have pledged not to talk about the JNC 8 process until transition from the NHLBI works itself out, but he offered this succinct observation: The ACC "has made a commitment to go forward with the JNC process. There will be a publication from that panel, although it may not have that name."
Dr. Smith and Dr. Williams said that they had no relevant disclosures.
On Twitter @mitchelzoler
The two U.S. groups most active in issuing guidelines and recommendations for cardiovascular disease diagnosis and management, the American College of Cardiology and American Heart Association, received a surprise in June when the National Heart, Lung, and Blood Institute suddenly announced that it would shift to these and other "partner organizations" primary responsibility for the next updates of U.S. hypertension guidelines, national cholesterol-management guidelines, and the other cardiovascular disease–related management recommendations that the institute has had in the works.
The NHLBI launched "a collaborative relationship with the ACC, AHA, and other organizations because they said they are not in a position to endorse guidelines, they must be endorsed by other organizations," said Dr. Sidney C. Smith Jr., professor of medicine at the University of North Carolina in Chapel Hill. Dr. Smith is a member of the panel that’s been writing the Eighth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8), and has been active for a long time in the ACC and AHA guidelines-development process.
On June 19, Dr. Gary H. Gibbons, NHLBI director, and his associates announced that effective immediately the institute was getting out of the guidelines-issuing business (Circulation 2013; doi: 10.1161/CIRCULATIONAHA.113.004587).
"Just over the past couple of months we began to look at how this will be done. Everyone wants the process to move quickly. How quickly can these organizations put it together? That’s the limiting factor right now," Dr. Smith said in an interview in early September.
While the ACC and AHA have on record some 20 sets of practice guidelines that cover most facets of cardiology, their list omits areas that the NHLBI covered in the past, notably hypertension and hypercholesterolemia assessment and management.
"The ACC and AHA guideline process is very expensive, and we wouldn’t dream of duplicating something when people you trust were commissioned by someone else [NHLBI] to do the work," said Dr. Kim Allan Williams Sr. of Wayne State University, Detroit. Dr. Williams will take the position of professor of medicine and chief of cardiovascular services at Rush University Medical Center in Chicago on Nov. 1. He serves as vice-president of the ACC. "We have all been under the impression that JNC 8 was being put together and getting published soon," he said in an interview.
Dr. Williams stressed that he and other ACC officials have pledged not to talk about the JNC 8 process until transition from the NHLBI works itself out, but he offered this succinct observation: The ACC "has made a commitment to go forward with the JNC process. There will be a publication from that panel, although it may not have that name."
Dr. Smith and Dr. Williams said that they had no relevant disclosures.
On Twitter @mitchelzoler
The two U.S. groups most active in issuing guidelines and recommendations for cardiovascular disease diagnosis and management, the American College of Cardiology and American Heart Association, received a surprise in June when the National Heart, Lung, and Blood Institute suddenly announced that it would shift to these and other "partner organizations" primary responsibility for the next updates of U.S. hypertension guidelines, national cholesterol-management guidelines, and the other cardiovascular disease–related management recommendations that the institute has had in the works.
The NHLBI launched "a collaborative relationship with the ACC, AHA, and other organizations because they said they are not in a position to endorse guidelines, they must be endorsed by other organizations," said Dr. Sidney C. Smith Jr., professor of medicine at the University of North Carolina in Chapel Hill. Dr. Smith is a member of the panel that’s been writing the Eighth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8), and has been active for a long time in the ACC and AHA guidelines-development process.
On June 19, Dr. Gary H. Gibbons, NHLBI director, and his associates announced that effective immediately the institute was getting out of the guidelines-issuing business (Circulation 2013; doi: 10.1161/CIRCULATIONAHA.113.004587).
"Just over the past couple of months we began to look at how this will be done. Everyone wants the process to move quickly. How quickly can these organizations put it together? That’s the limiting factor right now," Dr. Smith said in an interview in early September.
While the ACC and AHA have on record some 20 sets of practice guidelines that cover most facets of cardiology, their list omits areas that the NHLBI covered in the past, notably hypertension and hypercholesterolemia assessment and management.
"The ACC and AHA guideline process is very expensive, and we wouldn’t dream of duplicating something when people you trust were commissioned by someone else [NHLBI] to do the work," said Dr. Kim Allan Williams Sr. of Wayne State University, Detroit. Dr. Williams will take the position of professor of medicine and chief of cardiovascular services at Rush University Medical Center in Chicago on Nov. 1. He serves as vice-president of the ACC. "We have all been under the impression that JNC 8 was being put together and getting published soon," he said in an interview.
Dr. Williams stressed that he and other ACC officials have pledged not to talk about the JNC 8 process until transition from the NHLBI works itself out, but he offered this succinct observation: The ACC "has made a commitment to go forward with the JNC process. There will be a publication from that panel, although it may not have that name."
Dr. Smith and Dr. Williams said that they had no relevant disclosures.
On Twitter @mitchelzoler
Guidelines issued on radiation-induced heart disease
Cancer patients undergoing radiation therapy need to have baseline studies of cardiac function and routine screening for heart disease, according to recommendations from the European Society of Cardiology and the American Society of Echocardiography published July 16 in the European Heart Journal–Cardiovascular Imaging.
The groups recommend baseline preradiation echocardiography along with a cardiac exam as well as screening for risk factors. An annual cardiac history and physical should be performed to check for new-onset heart problems.
Within 10 years of treatment, 10%-30% of patients who undergo radiation therapy develop radiation-induced heart diseases (RIHD), including chronic pericarditis, myocardial fibrosis, coronary artery disease, aortic calcification, and valve regurgitation or stenosis. The hope of screening is to catch early RIHD, but screening is not currently routine.
"We wrote the expert consensus to raise the alarm that the risks of radiation-induced heart disease should not be ignored. The prevalence ... is increasing because the rate of cancer survival has improved," said Dr. Patrizio Lancellotti, who is a professor of cardiology at the University Hospital of Liège, Belgium, and led the recommendations task force.
Radiotherapy is given in more targeted form and at lower doses than it once was, but "patients are still at increased risk of RIHD, particularly when the heart is in the radiation field. This applies to patients treated for lymphoma, breast cancer, and esophageal cancer. Patients who receive radiotherapy for neck cancer are also at risk because lesions can develop on the carotid artery and increase the risk of stroke," Dr. Lancellotti said in a statement.
Using targeted radiation and alternate radiation fields, with avoidance and shielding of the heart, remain "the most important interventions to prevent" cardiac complications, the authors noted.
The task force advises that high-risk patients without evidence of heart disease on history and physical should have screening echocardiography every 5 years and noninvasive stress testing every 5-10 years; low-risk patients should have screening echocardiography every 10 years. If heart disorders are detected, routine monitoring should include echocardiography, cardiac magnetic resonance imaging, or carotid ultrasound as appropriate.
High-risk patients include those who received radiotherapy at younger ages; those who have cardiovascular risk factors or preexisting heart disease; and those who receive high-dose radiation (greater than 30 Gy), concomitant chemotherapy, radiation without shielding, or anterior or left chest radiation (Eur. Heart J. Cardiovasc. Imaging 2013;14:721-40).
The recommendations are based on an extensive literature review and analysis by Dr. Lancellotti and other specialists.
The authors reported no financial conflicts or outside funding for their work.
Cancer patients undergoing radiation therapy need to have baseline studies of cardiac function and routine screening for heart disease, according to recommendations from the European Society of Cardiology and the American Society of Echocardiography published July 16 in the European Heart Journal–Cardiovascular Imaging.
The groups recommend baseline preradiation echocardiography along with a cardiac exam as well as screening for risk factors. An annual cardiac history and physical should be performed to check for new-onset heart problems.
Within 10 years of treatment, 10%-30% of patients who undergo radiation therapy develop radiation-induced heart diseases (RIHD), including chronic pericarditis, myocardial fibrosis, coronary artery disease, aortic calcification, and valve regurgitation or stenosis. The hope of screening is to catch early RIHD, but screening is not currently routine.
"We wrote the expert consensus to raise the alarm that the risks of radiation-induced heart disease should not be ignored. The prevalence ... is increasing because the rate of cancer survival has improved," said Dr. Patrizio Lancellotti, who is a professor of cardiology at the University Hospital of Liège, Belgium, and led the recommendations task force.
Radiotherapy is given in more targeted form and at lower doses than it once was, but "patients are still at increased risk of RIHD, particularly when the heart is in the radiation field. This applies to patients treated for lymphoma, breast cancer, and esophageal cancer. Patients who receive radiotherapy for neck cancer are also at risk because lesions can develop on the carotid artery and increase the risk of stroke," Dr. Lancellotti said in a statement.
Using targeted radiation and alternate radiation fields, with avoidance and shielding of the heart, remain "the most important interventions to prevent" cardiac complications, the authors noted.
The task force advises that high-risk patients without evidence of heart disease on history and physical should have screening echocardiography every 5 years and noninvasive stress testing every 5-10 years; low-risk patients should have screening echocardiography every 10 years. If heart disorders are detected, routine monitoring should include echocardiography, cardiac magnetic resonance imaging, or carotid ultrasound as appropriate.
High-risk patients include those who received radiotherapy at younger ages; those who have cardiovascular risk factors or preexisting heart disease; and those who receive high-dose radiation (greater than 30 Gy), concomitant chemotherapy, radiation without shielding, or anterior or left chest radiation (Eur. Heart J. Cardiovasc. Imaging 2013;14:721-40).
The recommendations are based on an extensive literature review and analysis by Dr. Lancellotti and other specialists.
The authors reported no financial conflicts or outside funding for their work.
Cancer patients undergoing radiation therapy need to have baseline studies of cardiac function and routine screening for heart disease, according to recommendations from the European Society of Cardiology and the American Society of Echocardiography published July 16 in the European Heart Journal–Cardiovascular Imaging.
The groups recommend baseline preradiation echocardiography along with a cardiac exam as well as screening for risk factors. An annual cardiac history and physical should be performed to check for new-onset heart problems.
Within 10 years of treatment, 10%-30% of patients who undergo radiation therapy develop radiation-induced heart diseases (RIHD), including chronic pericarditis, myocardial fibrosis, coronary artery disease, aortic calcification, and valve regurgitation or stenosis. The hope of screening is to catch early RIHD, but screening is not currently routine.
"We wrote the expert consensus to raise the alarm that the risks of radiation-induced heart disease should not be ignored. The prevalence ... is increasing because the rate of cancer survival has improved," said Dr. Patrizio Lancellotti, who is a professor of cardiology at the University Hospital of Liège, Belgium, and led the recommendations task force.
Radiotherapy is given in more targeted form and at lower doses than it once was, but "patients are still at increased risk of RIHD, particularly when the heart is in the radiation field. This applies to patients treated for lymphoma, breast cancer, and esophageal cancer. Patients who receive radiotherapy for neck cancer are also at risk because lesions can develop on the carotid artery and increase the risk of stroke," Dr. Lancellotti said in a statement.
Using targeted radiation and alternate radiation fields, with avoidance and shielding of the heart, remain "the most important interventions to prevent" cardiac complications, the authors noted.
The task force advises that high-risk patients without evidence of heart disease on history and physical should have screening echocardiography every 5 years and noninvasive stress testing every 5-10 years; low-risk patients should have screening echocardiography every 10 years. If heart disorders are detected, routine monitoring should include echocardiography, cardiac magnetic resonance imaging, or carotid ultrasound as appropriate.
High-risk patients include those who received radiotherapy at younger ages; those who have cardiovascular risk factors or preexisting heart disease; and those who receive high-dose radiation (greater than 30 Gy), concomitant chemotherapy, radiation without shielding, or anterior or left chest radiation (Eur. Heart J. Cardiovasc. Imaging 2013;14:721-40).
The recommendations are based on an extensive literature review and analysis by Dr. Lancellotti and other specialists.
The authors reported no financial conflicts or outside funding for their work.
FROM THE EUROPEAN HEART JOURNAL – CARDIOVASCULAR IMAGING
Upcoming guidelines on inherited arrhythmias contain surprises
DENVER – Major new guidelines on the diagnosis and management of patients with inherited primary arrhythmia syndromes have been jointly issued by the Heart Rhythm Society and its European and Asian counterparts.
The guidelines were sorely needed, according to Dr. Silvia G. Priori, cochair of the expert consensus panel writing group.
The field of inherited arrhythmias is rapidly evolving, with new pathogenic genetic mutations being found all the time. Much has changed in the 7 years since issuance of the last major guidelines: the American College of Cardiology/American Heart Association/European Society of Cardiology guidelines on prevention of sudden cardiac death (Circulation 2006;114:e385-484), noted Dr. Priori of the University of Pavia (Italy).
Her cochair, Dr. Arthur A. Wilde of the University of Amsterdam pointed out that the new 69-page report is the first major document to address some of the newer inherited arrhythmia syndromes, including catecholaminergic polymorphic ventricular tachycardia (CPVT), short QT syndrome, early repolarization, and progressive cardiac conduction disease (PCCD). In addition, the new report proposes major changes in the diagnostic criteria for the two most common primary arrhythmia syndromes: long QT syndrome (LQTS) and Brugada syndrome.
"Many of our colleagues in the field will be surprised," Dr. Priori predicted.
Here are the highlights:
• LQTS: With an estimated prevalence of roughly 1 per 2,000 live births worldwide, this is the most common of the inherited arrhythmia syndromes. What is likely to come as a surprise to many physicians is the expert consensus panel’s recommendation that the diagnosis of LQTS requires either the finding of an unequivocally causative mutation in one of the LQTS genes or, in the absence of such a defect, either a QTc interval of 480-499 ms in repeated 12-lead ECGs in a patient with unexplained syncope or a QTc of 500 ms in repeated ECGs in the absence of a secondary cause for QT prolongation in a nonsyncopal patient.
"A single ECG reading 10 ms above the upper limit of normal is not enough to establish the diagnosis. That’s quite different from what’s being done in common practice. Many of the patients who are referred to the centers of expertise on inherited arrhythmias are borderline patients in whom maybe one ECG was abnormal, and yet because of that they’ve been labeled as being affected by a genetic disease even if the genetic studies were negative. A single abnormal QTc measurement in a patient with negative genetic testing is not enough," Dr. Priori declared.
Dr. Wilde said the new guidelines loosen up the guidance on participation in competitive sports. The blanket prohibition of the past has been replaced by a case-by-case approach, with a Class I recommendation for routine referral to a clinical expert for evaluation of the risk posed by athletic activity. For example, although swimming is a very-high-risk activity for patients with the LQTS1 genotype, that’s not true for those who have LQTS2 or -3.
"It’s clear that if a patient with long QT syndrome has exercise-related syncopal events, that patient should not participate in competitive sports. But if the patient is asymptomatic and has minor QT prolongation, there’s probably not much reason for concern," he said.
"This is a sharp departure," Dr. Priori observed. "In several European countries, if you have the diagnosis of long QT syndrome, sports participation is not permitted, even if your physician clears you. So we hope with this document to slowly, carefully, begin to allow patients with this condition to do sports safely. We wanted to lift the ban so that a physician who feels a specific patient would have a low risk in the proper environment could make that recommendation."
• Brugada syndrome: Far more common in Asia than the western world, Brugada syndrome is 8- to 10-fold more frequent in males than females. The big change in the new guidelines is that the diagnosis no longer requires specific ECG changes plus clinical manifestations. Now, Brugada syndrome, like LQTS, is a pure ECG diagnosis. It is made definitively when a type 1 ST-segment elevation is noted either spontaneously or after administration of an intravenous sodium channel-blocking agent; the ST finding has to be observed in at least one right precordial lead placed in a standard or superior position up to the second intercostal space.
An implantable cardioverter-defibrillator is clearly indicated in a Brugada syndrome patient with a prior cardiac arrest or documented ventricular arrhythmias. The controversy lies in how to manage the asymptomatic patient. The guidelines give ICD implantation a weak Class IIb recommendation – meaning it "may be considered" – when such patients exhibit inducible ventricular arrhythmias during programmed electrical stimulation in the electrophysiology lab.
• Catecholaminergic polymorphic ventricular tachycardia: The prevalence of CPVT is unclear, but it has been estimated at 1 per 5,000 live births, according to Dr. Wilde. This highly malignant condition is diagnosed in patients with a known pathogenic mutation, or in the presence of a structurally normal heart, a normal resting ECG, and unexplained exercise- or catecholamine-induced bidirectional VT of polymorphic ventricular premature beats or VT before age 40 years. First-line therapy is a long-acting beta-blocker such as nadolol, coupled with exercise restriction. ICD therapy is problematic because the inevitable inappropriate shocks increase sympathetic tone, triggering true shockable arrhythmias in a vicious cycle.
• Short QT syndrome: This is a rare channelopathy. It is diagnosed on the basis of a QTc of 330 ms or less, or a QTc of less than 360 ms in the presence of a pathogenic mutation, family history of sudden death before age 40 years, cardiac arrest in the absence of structural heart disease, or a family history of short QT syndrome.
• Progressive cardiac conduction disease: Still incompletely understood, PCCD is diagnosed in individuals under age 50 years who have unexplained progressive conduction abnormalities and a structurally normal heart with no skeletal myopathies. Pacemaker implantation is the most useful therapy.
• Early repolarization: The first report linking this extremely common ECG finding to sudden death came less than 5 years ago. Early repolarization, as characterized by J-point and ST-segment elevation in two or more contiguous leads, is present in up to 10% of normal individuals. In preparticipation athletic screening programs, it can be found in up to 15%-20% of subjects.
"There’s no reason for concern if that’s the only thing you find. It’s something you shouldn’t even communicate if there is no other issue. If a patient with early repolarization has no symptoms and no family history of premature sudden death, just leave it," Dr. Wilde advised.
On the other hand, if a patient with the early repolarization ECG pattern in two or more contiguous inferior and/or lateral leads experiences exercise-induced syncopal symptoms, further evaluation is warranted. Given how common and generally benign the early repolarization ECG pattern is, the expert panel recommended a conservative approach to diagnosis, urging that the formal diagnosis of early repolarization syndrome be restricted largely to those with the characteristic ECG findings who in addition have been resuscitated from unexplained ventricular fibrillation or polymorphic VT.
Dr. Priori emphasized that the guidelines have as a Class I recommendation that patients with a diagnosed or suspected inherited arrhythmia syndrome that can result in sudden cardiac death – and their first-degree relatives, as well – should be evaluated in a specialized multidisciplinary inherited arrhythmia clinic. Such clinics are more common in Europe than the United States; however, thought leaders in American electrophysiology now recognize that the increasing complexity of the field requires that more of these dedicated clinics be created in the United States, she said.
The expert consensus statement was a joint project of the Heart Rhythm Society, the European Heart Rhythm Association, and the Asia Pacific Heart Rhythm Society. The document is available at the HRS website and will be published this fall in Heart Rhythm, EP Europace, and the Journal of Arrhythmias.
Dr. Priori reported serving as a consultant to Medtronic, Boston Scientific, Biotronic, and Transgenomic. Dr. Wilde disclosed serving as a consultant to Sorin.
inherited primary arrhythmia, Dr. Silvia G. Priori, arrythmia guidelines, Arthur Wilde
DENVER – Major new guidelines on the diagnosis and management of patients with inherited primary arrhythmia syndromes have been jointly issued by the Heart Rhythm Society and its European and Asian counterparts.
The guidelines were sorely needed, according to Dr. Silvia G. Priori, cochair of the expert consensus panel writing group.
The field of inherited arrhythmias is rapidly evolving, with new pathogenic genetic mutations being found all the time. Much has changed in the 7 years since issuance of the last major guidelines: the American College of Cardiology/American Heart Association/European Society of Cardiology guidelines on prevention of sudden cardiac death (Circulation 2006;114:e385-484), noted Dr. Priori of the University of Pavia (Italy).
Her cochair, Dr. Arthur A. Wilde of the University of Amsterdam pointed out that the new 69-page report is the first major document to address some of the newer inherited arrhythmia syndromes, including catecholaminergic polymorphic ventricular tachycardia (CPVT), short QT syndrome, early repolarization, and progressive cardiac conduction disease (PCCD). In addition, the new report proposes major changes in the diagnostic criteria for the two most common primary arrhythmia syndromes: long QT syndrome (LQTS) and Brugada syndrome.
"Many of our colleagues in the field will be surprised," Dr. Priori predicted.
Here are the highlights:
• LQTS: With an estimated prevalence of roughly 1 per 2,000 live births worldwide, this is the most common of the inherited arrhythmia syndromes. What is likely to come as a surprise to many physicians is the expert consensus panel’s recommendation that the diagnosis of LQTS requires either the finding of an unequivocally causative mutation in one of the LQTS genes or, in the absence of such a defect, either a QTc interval of 480-499 ms in repeated 12-lead ECGs in a patient with unexplained syncope or a QTc of 500 ms in repeated ECGs in the absence of a secondary cause for QT prolongation in a nonsyncopal patient.
"A single ECG reading 10 ms above the upper limit of normal is not enough to establish the diagnosis. That’s quite different from what’s being done in common practice. Many of the patients who are referred to the centers of expertise on inherited arrhythmias are borderline patients in whom maybe one ECG was abnormal, and yet because of that they’ve been labeled as being affected by a genetic disease even if the genetic studies were negative. A single abnormal QTc measurement in a patient with negative genetic testing is not enough," Dr. Priori declared.
Dr. Wilde said the new guidelines loosen up the guidance on participation in competitive sports. The blanket prohibition of the past has been replaced by a case-by-case approach, with a Class I recommendation for routine referral to a clinical expert for evaluation of the risk posed by athletic activity. For example, although swimming is a very-high-risk activity for patients with the LQTS1 genotype, that’s not true for those who have LQTS2 or -3.
"It’s clear that if a patient with long QT syndrome has exercise-related syncopal events, that patient should not participate in competitive sports. But if the patient is asymptomatic and has minor QT prolongation, there’s probably not much reason for concern," he said.
"This is a sharp departure," Dr. Priori observed. "In several European countries, if you have the diagnosis of long QT syndrome, sports participation is not permitted, even if your physician clears you. So we hope with this document to slowly, carefully, begin to allow patients with this condition to do sports safely. We wanted to lift the ban so that a physician who feels a specific patient would have a low risk in the proper environment could make that recommendation."
• Brugada syndrome: Far more common in Asia than the western world, Brugada syndrome is 8- to 10-fold more frequent in males than females. The big change in the new guidelines is that the diagnosis no longer requires specific ECG changes plus clinical manifestations. Now, Brugada syndrome, like LQTS, is a pure ECG diagnosis. It is made definitively when a type 1 ST-segment elevation is noted either spontaneously or after administration of an intravenous sodium channel-blocking agent; the ST finding has to be observed in at least one right precordial lead placed in a standard or superior position up to the second intercostal space.
An implantable cardioverter-defibrillator is clearly indicated in a Brugada syndrome patient with a prior cardiac arrest or documented ventricular arrhythmias. The controversy lies in how to manage the asymptomatic patient. The guidelines give ICD implantation a weak Class IIb recommendation – meaning it "may be considered" – when such patients exhibit inducible ventricular arrhythmias during programmed electrical stimulation in the electrophysiology lab.
• Catecholaminergic polymorphic ventricular tachycardia: The prevalence of CPVT is unclear, but it has been estimated at 1 per 5,000 live births, according to Dr. Wilde. This highly malignant condition is diagnosed in patients with a known pathogenic mutation, or in the presence of a structurally normal heart, a normal resting ECG, and unexplained exercise- or catecholamine-induced bidirectional VT of polymorphic ventricular premature beats or VT before age 40 years. First-line therapy is a long-acting beta-blocker such as nadolol, coupled with exercise restriction. ICD therapy is problematic because the inevitable inappropriate shocks increase sympathetic tone, triggering true shockable arrhythmias in a vicious cycle.
• Short QT syndrome: This is a rare channelopathy. It is diagnosed on the basis of a QTc of 330 ms or less, or a QTc of less than 360 ms in the presence of a pathogenic mutation, family history of sudden death before age 40 years, cardiac arrest in the absence of structural heart disease, or a family history of short QT syndrome.
• Progressive cardiac conduction disease: Still incompletely understood, PCCD is diagnosed in individuals under age 50 years who have unexplained progressive conduction abnormalities and a structurally normal heart with no skeletal myopathies. Pacemaker implantation is the most useful therapy.
• Early repolarization: The first report linking this extremely common ECG finding to sudden death came less than 5 years ago. Early repolarization, as characterized by J-point and ST-segment elevation in two or more contiguous leads, is present in up to 10% of normal individuals. In preparticipation athletic screening programs, it can be found in up to 15%-20% of subjects.
"There’s no reason for concern if that’s the only thing you find. It’s something you shouldn’t even communicate if there is no other issue. If a patient with early repolarization has no symptoms and no family history of premature sudden death, just leave it," Dr. Wilde advised.
On the other hand, if a patient with the early repolarization ECG pattern in two or more contiguous inferior and/or lateral leads experiences exercise-induced syncopal symptoms, further evaluation is warranted. Given how common and generally benign the early repolarization ECG pattern is, the expert panel recommended a conservative approach to diagnosis, urging that the formal diagnosis of early repolarization syndrome be restricted largely to those with the characteristic ECG findings who in addition have been resuscitated from unexplained ventricular fibrillation or polymorphic VT.
Dr. Priori emphasized that the guidelines have as a Class I recommendation that patients with a diagnosed or suspected inherited arrhythmia syndrome that can result in sudden cardiac death – and their first-degree relatives, as well – should be evaluated in a specialized multidisciplinary inherited arrhythmia clinic. Such clinics are more common in Europe than the United States; however, thought leaders in American electrophysiology now recognize that the increasing complexity of the field requires that more of these dedicated clinics be created in the United States, she said.
The expert consensus statement was a joint project of the Heart Rhythm Society, the European Heart Rhythm Association, and the Asia Pacific Heart Rhythm Society. The document is available at the HRS website and will be published this fall in Heart Rhythm, EP Europace, and the Journal of Arrhythmias.
Dr. Priori reported serving as a consultant to Medtronic, Boston Scientific, Biotronic, and Transgenomic. Dr. Wilde disclosed serving as a consultant to Sorin.
DENVER – Major new guidelines on the diagnosis and management of patients with inherited primary arrhythmia syndromes have been jointly issued by the Heart Rhythm Society and its European and Asian counterparts.
The guidelines were sorely needed, according to Dr. Silvia G. Priori, cochair of the expert consensus panel writing group.
The field of inherited arrhythmias is rapidly evolving, with new pathogenic genetic mutations being found all the time. Much has changed in the 7 years since issuance of the last major guidelines: the American College of Cardiology/American Heart Association/European Society of Cardiology guidelines on prevention of sudden cardiac death (Circulation 2006;114:e385-484), noted Dr. Priori of the University of Pavia (Italy).
Her cochair, Dr. Arthur A. Wilde of the University of Amsterdam pointed out that the new 69-page report is the first major document to address some of the newer inherited arrhythmia syndromes, including catecholaminergic polymorphic ventricular tachycardia (CPVT), short QT syndrome, early repolarization, and progressive cardiac conduction disease (PCCD). In addition, the new report proposes major changes in the diagnostic criteria for the two most common primary arrhythmia syndromes: long QT syndrome (LQTS) and Brugada syndrome.
"Many of our colleagues in the field will be surprised," Dr. Priori predicted.
Here are the highlights:
• LQTS: With an estimated prevalence of roughly 1 per 2,000 live births worldwide, this is the most common of the inherited arrhythmia syndromes. What is likely to come as a surprise to many physicians is the expert consensus panel’s recommendation that the diagnosis of LQTS requires either the finding of an unequivocally causative mutation in one of the LQTS genes or, in the absence of such a defect, either a QTc interval of 480-499 ms in repeated 12-lead ECGs in a patient with unexplained syncope or a QTc of 500 ms in repeated ECGs in the absence of a secondary cause for QT prolongation in a nonsyncopal patient.
"A single ECG reading 10 ms above the upper limit of normal is not enough to establish the diagnosis. That’s quite different from what’s being done in common practice. Many of the patients who are referred to the centers of expertise on inherited arrhythmias are borderline patients in whom maybe one ECG was abnormal, and yet because of that they’ve been labeled as being affected by a genetic disease even if the genetic studies were negative. A single abnormal QTc measurement in a patient with negative genetic testing is not enough," Dr. Priori declared.
Dr. Wilde said the new guidelines loosen up the guidance on participation in competitive sports. The blanket prohibition of the past has been replaced by a case-by-case approach, with a Class I recommendation for routine referral to a clinical expert for evaluation of the risk posed by athletic activity. For example, although swimming is a very-high-risk activity for patients with the LQTS1 genotype, that’s not true for those who have LQTS2 or -3.
"It’s clear that if a patient with long QT syndrome has exercise-related syncopal events, that patient should not participate in competitive sports. But if the patient is asymptomatic and has minor QT prolongation, there’s probably not much reason for concern," he said.
"This is a sharp departure," Dr. Priori observed. "In several European countries, if you have the diagnosis of long QT syndrome, sports participation is not permitted, even if your physician clears you. So we hope with this document to slowly, carefully, begin to allow patients with this condition to do sports safely. We wanted to lift the ban so that a physician who feels a specific patient would have a low risk in the proper environment could make that recommendation."
• Brugada syndrome: Far more common in Asia than the western world, Brugada syndrome is 8- to 10-fold more frequent in males than females. The big change in the new guidelines is that the diagnosis no longer requires specific ECG changes plus clinical manifestations. Now, Brugada syndrome, like LQTS, is a pure ECG diagnosis. It is made definitively when a type 1 ST-segment elevation is noted either spontaneously or after administration of an intravenous sodium channel-blocking agent; the ST finding has to be observed in at least one right precordial lead placed in a standard or superior position up to the second intercostal space.
An implantable cardioverter-defibrillator is clearly indicated in a Brugada syndrome patient with a prior cardiac arrest or documented ventricular arrhythmias. The controversy lies in how to manage the asymptomatic patient. The guidelines give ICD implantation a weak Class IIb recommendation – meaning it "may be considered" – when such patients exhibit inducible ventricular arrhythmias during programmed electrical stimulation in the electrophysiology lab.
• Catecholaminergic polymorphic ventricular tachycardia: The prevalence of CPVT is unclear, but it has been estimated at 1 per 5,000 live births, according to Dr. Wilde. This highly malignant condition is diagnosed in patients with a known pathogenic mutation, or in the presence of a structurally normal heart, a normal resting ECG, and unexplained exercise- or catecholamine-induced bidirectional VT of polymorphic ventricular premature beats or VT before age 40 years. First-line therapy is a long-acting beta-blocker such as nadolol, coupled with exercise restriction. ICD therapy is problematic because the inevitable inappropriate shocks increase sympathetic tone, triggering true shockable arrhythmias in a vicious cycle.
• Short QT syndrome: This is a rare channelopathy. It is diagnosed on the basis of a QTc of 330 ms or less, or a QTc of less than 360 ms in the presence of a pathogenic mutation, family history of sudden death before age 40 years, cardiac arrest in the absence of structural heart disease, or a family history of short QT syndrome.
• Progressive cardiac conduction disease: Still incompletely understood, PCCD is diagnosed in individuals under age 50 years who have unexplained progressive conduction abnormalities and a structurally normal heart with no skeletal myopathies. Pacemaker implantation is the most useful therapy.
• Early repolarization: The first report linking this extremely common ECG finding to sudden death came less than 5 years ago. Early repolarization, as characterized by J-point and ST-segment elevation in two or more contiguous leads, is present in up to 10% of normal individuals. In preparticipation athletic screening programs, it can be found in up to 15%-20% of subjects.
"There’s no reason for concern if that’s the only thing you find. It’s something you shouldn’t even communicate if there is no other issue. If a patient with early repolarization has no symptoms and no family history of premature sudden death, just leave it," Dr. Wilde advised.
On the other hand, if a patient with the early repolarization ECG pattern in two or more contiguous inferior and/or lateral leads experiences exercise-induced syncopal symptoms, further evaluation is warranted. Given how common and generally benign the early repolarization ECG pattern is, the expert panel recommended a conservative approach to diagnosis, urging that the formal diagnosis of early repolarization syndrome be restricted largely to those with the characteristic ECG findings who in addition have been resuscitated from unexplained ventricular fibrillation or polymorphic VT.
Dr. Priori emphasized that the guidelines have as a Class I recommendation that patients with a diagnosed or suspected inherited arrhythmia syndrome that can result in sudden cardiac death – and their first-degree relatives, as well – should be evaluated in a specialized multidisciplinary inherited arrhythmia clinic. Such clinics are more common in Europe than the United States; however, thought leaders in American electrophysiology now recognize that the increasing complexity of the field requires that more of these dedicated clinics be created in the United States, she said.
The expert consensus statement was a joint project of the Heart Rhythm Society, the European Heart Rhythm Association, and the Asia Pacific Heart Rhythm Society. The document is available at the HRS website and will be published this fall in Heart Rhythm, EP Europace, and the Journal of Arrhythmias.
Dr. Priori reported serving as a consultant to Medtronic, Boston Scientific, Biotronic, and Transgenomic. Dr. Wilde disclosed serving as a consultant to Sorin.
inherited primary arrhythmia, Dr. Silvia G. Priori, arrythmia guidelines, Arthur Wilde
inherited primary arrhythmia, Dr. Silvia G. Priori, arrythmia guidelines, Arthur Wilde
AT HEART RHYTHM 2013