Heidi Splete

The transition of adolescents with congenital heart disease from pediatric to adult care should be targeted to the teen’s emotional and physical developmental status, according to a scientific statement from the American Heart Association.

The statement, "Best Practices in Managing Transition to Adulthood for Adolescents with Congenital Heart Disease: The Transition Process and Medical and Psychosocial Issues," was published online Feb. 28 in Circulation.

More children with congenital heart disease are surviving to adulthood, creating a need for programs to help them transition from pediatric to adult medical environments, said writing committee cochairs Dr. Craig Sable of Children’s National Medical Center in Washington and Dr. Elyse Foster of the University of California, San Francisco, and their colleagues.

An ideal transition program should "foster personal and medical independence and a greater sense of control over health, [health care] decisions, and psychosocial environment," the committee wrote (Circulation 2011 Feb. 28 [doi:10.1061/CIR.0b013e3182107c56]).

The statement recommends actively involving adolescents in the transition process, but timing the transition according to the patient’s emotional and developmental maturity. According to the AHA statement, the pediatric cardiologist should initiate a transition plan, and work with the adolescent to develop the plan. Clinicians should begin to direct health discussions toward the teen rather than the parent, and should encourage teens to talk privately (without a parent present) about their quality of life concerns, such as physical restrictions, school and peer issues, and other social relationships.

However, the AHA recommends that clinicians recognize parents’ fears and concerns, and solicit their opinions about what quality of life issues their teen might have, in addition to talking to the teen directly.

Ideally, an adolescent with CHD will have a medical home with a primary care provider who will maintain a confidential record of the patient’s medical information, the committee wrote. Once the patient is established with a cardiologist, that clinician should update the patient’s records with the primary care provider.

Surgical considerations for adolescents with CHD should include consulting an adult CHD (ACHD) expert during preoperative planning for elective surgery, choosing a clinical setting (pediatric or adult) based on the patient’s preferences and developmental status, and enlisting an anesthesiologist familiar with the physiology of adolescent CHD.

The statement lists additional issues to raise with adolescent CHD patients including genetic testing, sexuality and contraception, exercise, employment, and insurance. In all cases, discussion should be individualized based on the teen’s developmental status.

Many pediatric cardiologists continue to care for adolescents with CHD and developmental disabilities well into adulthood, but the AHA statement endorses the creation of individual transition plans to move these patients into successful adult CHD care, ideally as part of an overall transition plan from pediatric to adult health care.

The statement reviewed the following three key elements of the transition process from pediatric to adult CHD care that apply regardless of the specific transition model:

• Pretransition. The AHA recommends that children with CHD be introduced to the idea of managing their own health during childhood, so they can develop the necessary skills. One model for pretransition involves a nurse practitioner or physician assistant, who starts by counseling the adolescent about diet and exercise, contraception and pregnancy, high-risk behaviors, and other concerns.

• Transition. The AHA recommends that a transition curriculum educate teens about their medical history, diagnosis, and how their hearts are different. Teens in transition to adult care CHD should learn which symptoms are cause for concern, and understand different treatment options. Also, transitioning teens need to learn how to handle health insurance and how to schedule routine care visits and follow-up visits with specialists.

• Transfer. The AHA recommends transfer of care when adolescent CHD patients have shown an ability to meet their own health care needs independent of their families. The AHA does not recommend transfer from pediatric to adult care during medical crises or complications such as pregnancy, mental illness or noncompliance, to avoid additional psychological stress for the patient.

The recommendations were presented on behalf of the American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease.

According to the AHA statement, "It is hoped that in the near future, transition programs will become the standard of care, making it more likely that patients with complex chronic illness can achieve their full potential under appropriate medical surveillance and live meaningful and productive lives."

Many life changes take place during the late teens and early twenties, including evolving psychosocial, economic, geographic, and education or work factors, said Dr. Roberta G. Williams, a pediatric cardiologist at Children’s Hospital in Los Angeles. Preparing young people with chronic disease to transition to adult care must include an understanding of this framework in order to effectively transfer them to a system that requires self-determination.

Currently, this is done in a hit-or-miss fashion, she noted. Production of guidelines, developed by a consensus process, is an essential step toward changing practice patterns and planning for the institutional resources needed to facilitate successful transfer.

Surveys of pediatricians indicate that finding time to provide adolescents with appropriate guidance for their health care issues is a significant concern. Within pediatric cardiology programs, the guidance around lifestyle and health care is often provided by allied health professionals, but these resources are stretched thin, said Dr. Williams, who is also a member of the AHA writing committee that developed the statement..

Dr. Williams added that one of the most serious challenges facing doctors and patients is the lack of funding for case management that spans the period of transfer. Many of the problems faced by young people – particularly those with chronic disease – relate to financial and psychosocial issues. "Although most states provide funding to support advanced practice nursing and social services to pediatric programs, this support does not exist in the adult health care system except in the most extreme cases. Successful transfer requires not only a smooth takeoff, but also a secure landing. These resources must be developed for at least the 20-something population to ensure continued access to the appropriate health care providers," she said.

"My advice to clinicians is to start before the hormone surge. Preteens are often the most receptive," Dr. Williams suggested. It’s helpful to begin the conversation with the patient and family as soon as possible, and to repeat it often.

Dr. Sable had no financial conflicts to disclose. Cochair Dr. Elyse Foster of the University of California, San Francisco, has received research funding from Boston Scientific, Guidant, and Evalve Inc. Dr. Williams reported that she had no financial disclosures.

The transition of adolescents with congenital heart disease from pediatric to adult care should be targeted to the teen’s emotional and physical developmental status, according to a scientific statement from the American Heart Association.

The statement, "Best Practices in Managing Transition to Adulthood for Adolescents with Congenital Heart Disease: The Transition Process and Medical and Psychosocial Issues," was published online Feb. 28 in Circulation.

More children with congenital heart disease are surviving to adulthood, creating a need for programs to help them transition from pediatric to adult medical environments, said writing committee cochairs Dr. Craig Sable of Children’s National Medical Center in Washington and Dr. Elyse Foster of the University of California, San Francisco, and their colleagues.

An ideal transition program should "foster personal and medical independence and a greater sense of control over health, [health care] decisions, and psychosocial environment," the committee wrote (Circulation 2011 Feb. 28 [doi:10.1061/CIR.0b013e3182107c56]).

The statement recommends actively involving adolescents in the transition process, but timing the transition according to the patient’s emotional and developmental maturity. According to the AHA statement, the pediatric cardiologist should initiate a transition plan, and work with the adolescent to develop the plan. Clinicians should begin to direct health discussions toward the teen rather than the parent, and should encourage teens to talk privately (without a parent present) about their quality of life concerns, such as physical restrictions, school and peer issues, and other social relationships.

However, the AHA recommends that clinicians recognize parents’ fears and concerns, and solicit their opinions about what quality of life issues their teen might have, in addition to talking to the teen directly.

Ideally, an adolescent with CHD will have a medical home with a primary care provider who will maintain a confidential record of the patient’s medical information, the committee wrote. Once the patient is established with a cardiologist, that clinician should update the patient’s records with the primary care provider.

Surgical considerations for adolescents with CHD should include consulting an adult CHD (ACHD) expert during preoperative planning for elective surgery, choosing a clinical setting (pediatric or adult) based on the patient’s preferences and developmental status, and enlisting an anesthesiologist familiar with the physiology of adolescent CHD.

The statement lists additional issues to raise with adolescent CHD patients including genetic testing, sexuality and contraception, exercise, employment, and insurance. In all cases, discussion should be individualized based on the teen’s developmental status.

Many pediatric cardiologists continue to care for adolescents with CHD and developmental disabilities well into adulthood, but the AHA statement endorses the creation of individual transition plans to move these patients into successful adult CHD care, ideally as part of an overall transition plan from pediatric to adult health care.

The statement reviewed the following three key elements of the transition process from pediatric to adult CHD care that apply regardless of the specific transition model:

• Pretransition. The AHA recommends that children with CHD be introduced to the idea of managing their own health during childhood, so they can develop the necessary skills. One model for pretransition involves a nurse practitioner or physician assistant, who starts by counseling the adolescent about diet and exercise, contraception and pregnancy, high-risk behaviors, and other concerns.

• Transition. The AHA recommends that a transition curriculum educate teens about their medical history, diagnosis, and how their hearts are different. Teens in transition to adult care CHD should learn which symptoms are cause for concern, and understand different treatment options. Also, transitioning teens need to learn how to handle health insurance and how to schedule routine care visits and follow-up visits with specialists.

• Transfer. The AHA recommends transfer of care when adolescent CHD patients have shown an ability to meet their own health care needs independent of their families. The AHA does not recommend transfer from pediatric to adult care during medical crises or complications such as pregnancy, mental illness or noncompliance, to avoid additional psychological stress for the patient.

The recommendations were presented on behalf of the American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease.

According to the AHA statement, "It is hoped that in the near future, transition programs will become the standard of care, making it more likely that patients with complex chronic illness can achieve their full potential under appropriate medical surveillance and live meaningful and productive lives."

Many life changes take place during the late teens and early twenties, including evolving psychosocial, economic, geographic, and education or work factors, said Dr. Roberta G. Williams, a pediatric cardiologist at Children’s Hospital in Los Angeles. Preparing young people with chronic disease to transition to adult care must include an understanding of this framework in order to effectively transfer them to a system that requires self-determination.

Currently, this is done in a hit-or-miss fashion, she noted. Production of guidelines, developed by a consensus process, is an essential step toward changing practice patterns and planning for the institutional resources needed to facilitate successful transfer.

Surveys of pediatricians indicate that finding time to provide adolescents with appropriate guidance for their health care issues is a significant concern. Within pediatric cardiology programs, the guidance around lifestyle and health care is often provided by allied health professionals, but these resources are stretched thin, said Dr. Williams, who is also a member of the AHA writing committee that developed the statement..

Dr. Williams added that one of the most serious challenges facing doctors and patients is the lack of funding for case management that spans the period of transfer. Many of the problems faced by young people – particularly those with chronic disease – relate to financial and psychosocial issues. "Although most states provide funding to support advanced practice nursing and social services to pediatric programs, this support does not exist in the adult health care system except in the most extreme cases. Successful transfer requires not only a smooth takeoff, but also a secure landing. These resources must be developed for at least the 20-something population to ensure continued access to the appropriate health care providers," she said.

"My advice to clinicians is to start before the hormone surge. Preteens are often the most receptive," Dr. Williams suggested. It’s helpful to begin the conversation with the patient and family as soon as possible, and to repeat it often.

Dr. Sable had no financial conflicts to disclose. Cochair Dr. Elyse Foster of the University of California, San Francisco, has received research funding from Boston Scientific, Guidant, and Evalve Inc. Dr. Williams reported that she had no financial disclosures.

The transition of adolescents with congenital heart disease from pediatric to adult care should be targeted to the teen’s emotional and physical developmental status, according to a scientific statement from the American Heart Association.

The statement, "Best Practices in Managing Transition to Adulthood for Adolescents with Congenital Heart Disease: The Transition Process and Medical and Psychosocial Issues," was published online Feb. 28 in Circulation.

More children with congenital heart disease are surviving to adulthood, creating a need for programs to help them transition from pediatric to adult medical environments, said writing committee cochairs Dr. Craig Sable of Children’s National Medical Center in Washington and Dr. Elyse Foster of the University of California, San Francisco, and their colleagues.

An ideal transition program should "foster personal and medical independence and a greater sense of control over health, [health care] decisions, and psychosocial environment," the committee wrote (Circulation 2011 Feb. 28 [doi:10.1061/CIR.0b013e3182107c56]).

The statement recommends actively involving adolescents in the transition process, but timing the transition according to the patient’s emotional and developmental maturity. According to the AHA statement, the pediatric cardiologist should initiate a transition plan, and work with the adolescent to develop the plan. Clinicians should begin to direct health discussions toward the teen rather than the parent, and should encourage teens to talk privately (without a parent present) about their quality of life concerns, such as physical restrictions, school and peer issues, and other social relationships.

However, the AHA recommends that clinicians recognize parents’ fears and concerns, and solicit their opinions about what quality of life issues their teen might have, in addition to talking to the teen directly.

Ideally, an adolescent with CHD will have a medical home with a primary care provider who will maintain a confidential record of the patient’s medical information, the committee wrote. Once the patient is established with a cardiologist, that clinician should update the patient’s records with the primary care provider.

Surgical considerations for adolescents with CHD should include consulting an adult CHD (ACHD) expert during preoperative planning for elective surgery, choosing a clinical setting (pediatric or adult) based on the patient’s preferences and developmental status, and enlisting an anesthesiologist familiar with the physiology of adolescent CHD.

The statement lists additional issues to raise with adolescent CHD patients including genetic testing, sexuality and contraception, exercise, employment, and insurance. In all cases, discussion should be individualized based on the teen’s developmental status.

Many pediatric cardiologists continue to care for adolescents with CHD and developmental disabilities well into adulthood, but the AHA statement endorses the creation of individual transition plans to move these patients into successful adult CHD care, ideally as part of an overall transition plan from pediatric to adult health care.

The statement reviewed the following three key elements of the transition process from pediatric to adult CHD care that apply regardless of the specific transition model:

• Pretransition. The AHA recommends that children with CHD be introduced to the idea of managing their own health during childhood, so they can develop the necessary skills. One model for pretransition involves a nurse practitioner or physician assistant, who starts by counseling the adolescent about diet and exercise, contraception and pregnancy, high-risk behaviors, and other concerns.

• Transition. The AHA recommends that a transition curriculum educate teens about their medical history, diagnosis, and how their hearts are different. Teens in transition to adult care CHD should learn which symptoms are cause for concern, and understand different treatment options. Also, transitioning teens need to learn how to handle health insurance and how to schedule routine care visits and follow-up visits with specialists.

• Transfer. The AHA recommends transfer of care when adolescent CHD patients have shown an ability to meet their own health care needs independent of their families. The AHA does not recommend transfer from pediatric to adult care during medical crises or complications such as pregnancy, mental illness or noncompliance, to avoid additional psychological stress for the patient.

The recommendations were presented on behalf of the American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease.

According to the AHA statement, "It is hoped that in the near future, transition programs will become the standard of care, making it more likely that patients with complex chronic illness can achieve their full potential under appropriate medical surveillance and live meaningful and productive lives."

Many life changes take place during the late teens and early twenties, including evolving psychosocial, economic, geographic, and education or work factors, said Dr. Roberta G. Williams, a pediatric cardiologist at Children’s Hospital in Los Angeles. Preparing young people with chronic disease to transition to adult care must include an understanding of this framework in order to effectively transfer them to a system that requires self-determination.

Currently, this is done in a hit-or-miss fashion, she noted. Production of guidelines, developed by a consensus process, is an essential step toward changing practice patterns and planning for the institutional resources needed to facilitate successful transfer.

Surveys of pediatricians indicate that finding time to provide adolescents with appropriate guidance for their health care issues is a significant concern. Within pediatric cardiology programs, the guidance around lifestyle and health care is often provided by allied health professionals, but these resources are stretched thin, said Dr. Williams, who is also a member of the AHA writing committee that developed the statement..

Dr. Williams added that one of the most serious challenges facing doctors and patients is the lack of funding for case management that spans the period of transfer. Many of the problems faced by young people – particularly those with chronic disease – relate to financial and psychosocial issues. "Although most states provide funding to support advanced practice nursing and social services to pediatric programs, this support does not exist in the adult health care system except in the most extreme cases. Successful transfer requires not only a smooth takeoff, but also a secure landing. These resources must be developed for at least the 20-something population to ensure continued access to the appropriate health care providers," she said.

"My advice to clinicians is to start before the hormone surge. Preteens are often the most receptive," Dr. Williams suggested. It’s helpful to begin the conversation with the patient and family as soon as possible, and to repeat it often.

Dr. Sable had no financial conflicts to disclose. Cochair Dr. Elyse Foster of the University of California, San Francisco, has received research funding from Boston Scientific, Guidant, and Evalve Inc. Dr. Williams reported that she had no financial disclosures.

The transition of adolescents with congenital heart disease from pediatric to adult care should be targeted to the teen’s emotional and physical developmental status, according to a scientific statement from the American Heart Association.

The statement, "Best Practices in Managing Transition to Adulthood for Adolescents with Congenital Heart Disease: The Transition Process and Medical and Psychosocial Issues," was published online Feb. 28 in Circulation.

More children with congenital heart disease are surviving to adulthood, creating a need for programs to help them transition from pediatric to adult medical environments, said writing committee cochairs Dr. Craig Sable of Children’s National Medical Center in Washington and Dr. Elyse Foster of the University of California, San Francisco, and their colleagues.

An ideal transition program should "foster personal and medical independence and a greater sense of control over health, [health care] decisions, and psychosocial environment," the committee wrote (Circulation 2011 Feb. 28 [doi:10.1061/CIR.0b013e3182107c56]).

The statement recommends actively involving adolescents in the transition process, but timing the transition according to the patient’s emotional and developmental maturity. According to the AHA statement, the pediatric cardiologist should initiate a transition plan, and work with the adolescent to develop the plan. Clinicians should begin to direct health discussions toward the teen rather than the parent, and should encourage teens to talk privately (without a parent present) about their quality of life concerns, such as physical restrictions, school and peer issues, and other social relationships.

However, the AHA recommends that clinicians recognize parents’ fears and concerns, and solicit their opinions about what quality of life issues their teen might have, in addition to talking to the teen directly.

Ideally, an adolescent with CHD will have a medical home with a primary care provider who will maintain a confidential record of the patient’s medical information, the committee wrote. Once the patient is established with a cardiologist, that clinician should update the patient’s records with the primary care provider.

Surgical considerations for adolescents with CHD should include consulting an adult CHD (ACHD) expert during preoperative planning for elective surgery, choosing a clinical setting (pediatric or adult) based on the patient’s preferences and developmental status, and enlisting an anesthesiologist familiar with the physiology of adolescent CHD.

The statement lists additional issues to raise with adolescent CHD patients including genetic testing, sexuality and contraception, exercise, employment, and insurance. In all cases, discussion should be individualized based on the teen’s developmental status.

Many pediatric cardiologists continue to care for adolescents with CHD and developmental disabilities well into adulthood, but the AHA statement endorses the creation of individual transition plans to move these patients into successful adult CHD care, ideally as part of an overall transition plan from pediatric to adult health care.

The statement reviewed the following three key elements of the transition process from pediatric to adult CHD care that apply regardless of the specific transition model:

• Pretransition. The AHA recommends that children with CHD be introduced to the idea of managing their own health during childhood, so they can develop the necessary skills. One model for pretransition involves a nurse practitioner or physician assistant, who starts by counseling the adolescent about diet and exercise, contraception and pregnancy, high-risk behaviors, and other concerns.

• Transition. The AHA recommends that a transition curriculum educate teens about their medical history, diagnosis, and how their hearts are different. Teens in transition to adult care CHD should learn which symptoms are cause for concern, and understand different treatment options. Also, transitioning teens need to learn how to handle health insurance and how to schedule routine care visits and follow-up visits with specialists.

• Transfer. The AHA recommends transfer of care when adolescent CHD patients have shown an ability to meet their own health care needs independent of their families. The AHA does not recommend transfer from pediatric to adult care during medical crises or complications such as pregnancy, mental illness or noncompliance, to avoid additional psychological stress for the patient.

The recommendations were presented on behalf of the American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease.

According to the AHA statement, "It is hoped that in the near future, transition programs will become the standard of care, making it more likely that patients with complex chronic illness can achieve their full potential under appropriate medical surveillance and live meaningful and productive lives."

Many life changes take place during the late teens and early twenties, including evolving psychosocial, economic, geographic, and education or work factors, said Dr. Roberta G. Williams, a pediatric cardiologist at Children’s Hospital in Los Angeles. Preparing young people with chronic disease to transition to adult care must include an understanding of this framework in order to effectively transfer them to a system that requires self-determination.

Currently, this is done in a hit-or-miss fashion, she noted. Production of guidelines, developed by a consensus process, is an essential step toward changing practice patterns and planning for the institutional resources needed to facilitate successful transfer.

Surveys of pediatricians indicate that finding time to provide adolescents with appropriate guidance for their health care issues is a significant concern. Within pediatric cardiology programs, the guidance around lifestyle and health care is often provided by allied health professionals, but these resources are stretched thin, said Dr. Williams, who is also a member of the AHA writing committee that developed the statement..

Dr. Williams added that one of the most serious challenges facing doctors and patients is the lack of funding for case management that spans the period of transfer. Many of the problems faced by young people – particularly those with chronic disease – relate to financial and psychosocial issues. "Although most states provide funding to support advanced practice nursing and social services to pediatric programs, this support does not exist in the adult health care system except in the most extreme cases. Successful transfer requires not only a smooth takeoff, but also a secure landing. These resources must be developed for at least the 20-something population to ensure continued access to the appropriate health care providers," she said.

"My advice to clinicians is to start before the hormone surge. Preteens are often the most receptive," Dr. Williams suggested. It’s helpful to begin the conversation with the patient and family as soon as possible, and to repeat it often.

Dr. Sable had no financial conflicts to disclose. Cochair Dr. Elyse Foster of the University of California, San Francisco, has received research funding from Boston Scientific, Guidant, and Evalve Inc. Dr. Williams reported that she had no financial disclosures.

The transition of adolescents with congenital heart disease from pediatric to adult care should be targeted to the teen’s emotional and physical developmental status, according to a scientific statement from the American Heart Association.

The statement, "Best Practices in Managing Transition to Adulthood for Adolescents with Congenital Heart Disease: The Transition Process and Medical and Psychosocial Issues," was published online Feb. 28 in Circulation.

More children with congenital heart disease are surviving to adulthood, creating a need for programs to help them transition from pediatric to adult medical environments, said writing committee cochairs Dr. Craig Sable of Children’s National Medical Center in Washington and Dr. Elyse Foster of the University of California, San Francisco, and their colleagues.

An ideal transition program should "foster personal and medical independence and a greater sense of control over health, [health care] decisions, and psychosocial environment," the committee wrote (Circulation 2011 Feb. 28 [doi:10.1061/CIR.0b013e3182107c56]).

The statement recommends actively involving adolescents in the transition process, but timing the transition according to the patient’s emotional and developmental maturity. According to the AHA statement, the pediatric cardiologist should initiate a transition plan, and work with the adolescent to develop the plan. Clinicians should begin to direct health discussions toward the teen rather than the parent, and should encourage teens to talk privately (without a parent present) about their quality of life concerns, such as physical restrictions, school and peer issues, and other social relationships.

However, the AHA recommends that clinicians recognize parents’ fears and concerns, and solicit their opinions about what quality of life issues their teen might have, in addition to talking to the teen directly.

Ideally, an adolescent with CHD will have a medical home with a primary care provider who will maintain a confidential record of the patient’s medical information, the committee wrote. Once the patient is established with a cardiologist, that clinician should update the patient’s records with the primary care provider.

Surgical considerations for adolescents with CHD should include consulting an adult CHD (ACHD) expert during preoperative planning for elective surgery, choosing a clinical setting (pediatric or adult) based on the patient’s preferences and developmental status, and enlisting an anesthesiologist familiar with the physiology of adolescent CHD.

The statement lists additional issues to raise with adolescent CHD patients including genetic testing, sexuality and contraception, exercise, employment, and insurance. In all cases, discussion should be individualized based on the teen’s developmental status.

Many pediatric cardiologists continue to care for adolescents with CHD and developmental disabilities well into adulthood, but the AHA statement endorses the creation of individual transition plans to move these patients into successful adult CHD care, ideally as part of an overall transition plan from pediatric to adult health care.

The statement reviewed the following three key elements of the transition process from pediatric to adult CHD care that apply regardless of the specific transition model:

• Pretransition. The AHA recommends that children with CHD be introduced to the idea of managing their own health during childhood, so they can develop the necessary skills. One model for pretransition involves a nurse practitioner or physician assistant, who starts by counseling the adolescent about diet and exercise, contraception and pregnancy, high-risk behaviors, and other concerns.

• Transition. The AHA recommends that a transition curriculum educate teens about their medical history, diagnosis, and how their hearts are different. Teens in transition to adult care CHD should learn which symptoms are cause for concern, and understand different treatment options. Also, transitioning teens need to learn how to handle health insurance and how to schedule routine care visits and follow-up visits with specialists.

• Transfer. The AHA recommends transfer of care when adolescent CHD patients have shown an ability to meet their own health care needs independent of their families. The AHA does not recommend transfer from pediatric to adult care during medical crises or complications such as pregnancy, mental illness or noncompliance, to avoid additional psychological stress for the patient.

The recommendations were presented on behalf of the American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease.

According to the AHA statement, "It is hoped that in the near future, transition programs will become the standard of care, making it more likely that patients with complex chronic illness can achieve their full potential under appropriate medical surveillance and live meaningful and productive lives."

Many life changes take place during the late teens and early twenties, including evolving psychosocial, economic, geographic, and education or work factors, said Dr. Roberta G. Williams, a pediatric cardiologist at Children’s Hospital in Los Angeles. Preparing young people with chronic disease to transition to adult care must include an understanding of this framework in order to effectively transfer them to a system that requires self-determination.

Currently, this is done in a hit-or-miss fashion, she noted. Production of guidelines, developed by a consensus process, is an essential step toward changing practice patterns and planning for the institutional resources needed to facilitate successful transfer.

Surveys of pediatricians indicate that finding time to provide adolescents with appropriate guidance for their health care issues is a significant concern. Within pediatric cardiology programs, the guidance around lifestyle and health care is often provided by allied health professionals, but these resources are stretched thin, said Dr. Williams, who is also a member of the AHA writing committee that developed the statement..

Dr. Williams added that one of the most serious challenges facing doctors and patients is the lack of funding for case management that spans the period of transfer. Many of the problems faced by young people – particularly those with chronic disease – relate to financial and psychosocial issues. "Although most states provide funding to support advanced practice nursing and social services to pediatric programs, this support does not exist in the adult health care system except in the most extreme cases. Successful transfer requires not only a smooth takeoff, but also a secure landing. These resources must be developed for at least the 20-something population to ensure continued access to the appropriate health care providers," she said.

"My advice to clinicians is to start before the hormone surge. Preteens are often the most receptive," Dr. Williams suggested. It’s helpful to begin the conversation with the patient and family as soon as possible, and to repeat it often.

Dr. Sable had no financial conflicts to disclose. Cochair Dr. Elyse Foster of the University of California, San Francisco, has received research funding from Boston Scientific, Guidant, and Evalve Inc. Dr. Williams reported that she had no financial disclosures.

The transition of adolescents with congenital heart disease from pediatric to adult care should be targeted to the teen’s emotional and physical developmental status, according to a scientific statement from the American Heart Association.

The statement, "Best Practices in Managing Transition to Adulthood for Adolescents with Congenital Heart Disease: The Transition Process and Medical and Psychosocial Issues," was published online Feb. 28 in Circulation.

More children with congenital heart disease are surviving to adulthood, creating a need for programs to help them transition from pediatric to adult medical environments, said writing committee cochairs Dr. Craig Sable of Children’s National Medical Center in Washington and Dr. Elyse Foster of the University of California, San Francisco, and their colleagues.

An ideal transition program should "foster personal and medical independence and a greater sense of control over health, [health care] decisions, and psychosocial environment," the committee wrote (Circulation 2011 Feb. 28 [doi:10.1061/CIR.0b013e3182107c56]).

The statement recommends actively involving adolescents in the transition process, but timing the transition according to the patient’s emotional and developmental maturity. According to the AHA statement, the pediatric cardiologist should initiate a transition plan, and work with the adolescent to develop the plan. Clinicians should begin to direct health discussions toward the teen rather than the parent, and should encourage teens to talk privately (without a parent present) about their quality of life concerns, such as physical restrictions, school and peer issues, and other social relationships.

However, the AHA recommends that clinicians recognize parents’ fears and concerns, and solicit their opinions about what quality of life issues their teen might have, in addition to talking to the teen directly.

Ideally, an adolescent with CHD will have a medical home with a primary care provider who will maintain a confidential record of the patient’s medical information, the committee wrote. Once the patient is established with a cardiologist, that clinician should update the patient’s records with the primary care provider.

Surgical considerations for adolescents with CHD should include consulting an adult CHD (ACHD) expert during preoperative planning for elective surgery, choosing a clinical setting (pediatric or adult) based on the patient’s preferences and developmental status, and enlisting an anesthesiologist familiar with the physiology of adolescent CHD.

The statement lists additional issues to raise with adolescent CHD patients including genetic testing, sexuality and contraception, exercise, employment, and insurance. In all cases, discussion should be individualized based on the teen’s developmental status.

Many pediatric cardiologists continue to care for adolescents with CHD and developmental disabilities well into adulthood, but the AHA statement endorses the creation of individual transition plans to move these patients into successful adult CHD care, ideally as part of an overall transition plan from pediatric to adult health care.

The statement reviewed the following three key elements of the transition process from pediatric to adult CHD care that apply regardless of the specific transition model:

• Pretransition. The AHA recommends that children with CHD be introduced to the idea of managing their own health during childhood, so they can develop the necessary skills. One model for pretransition involves a nurse practitioner or physician assistant, who starts by counseling the adolescent about diet and exercise, contraception and pregnancy, high-risk behaviors, and other concerns.

• Transition. The AHA recommends that a transition curriculum educate teens about their medical history, diagnosis, and how their hearts are different. Teens in transition to adult care CHD should learn which symptoms are cause for concern, and understand different treatment options. Also, transitioning teens need to learn how to handle health insurance and how to schedule routine care visits and follow-up visits with specialists.

• Transfer. The AHA recommends transfer of care when adolescent CHD patients have shown an ability to meet their own health care needs independent of their families. The AHA does not recommend transfer from pediatric to adult care during medical crises or complications such as pregnancy, mental illness or noncompliance, to avoid additional psychological stress for the patient.

The recommendations were presented on behalf of the American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease.

According to the AHA statement, "It is hoped that in the near future, transition programs will become the standard of care, making it more likely that patients with complex chronic illness can achieve their full potential under appropriate medical surveillance and live meaningful and productive lives."

Many life changes take place during the late teens and early twenties, including evolving psychosocial, economic, geographic, and education or work factors, said Dr. Roberta G. Williams, a pediatric cardiologist at Children’s Hospital in Los Angeles. Preparing young people with chronic disease to transition to adult care must include an understanding of this framework in order to effectively transfer them to a system that requires self-determination.

Currently, this is done in a hit-or-miss fashion, she noted. Production of guidelines, developed by a consensus process, is an essential step toward changing practice patterns and planning for the institutional resources needed to facilitate successful transfer.

Surveys of pediatricians indicate that finding time to provide adolescents with appropriate guidance for their health care issues is a significant concern. Within pediatric cardiology programs, the guidance around lifestyle and health care is often provided by allied health professionals, but these resources are stretched thin, said Dr. Williams, who is also a member of the AHA writing committee that developed the statement..

Dr. Williams added that one of the most serious challenges facing doctors and patients is the lack of funding for case management that spans the period of transfer. Many of the problems faced by young people – particularly those with chronic disease – relate to financial and psychosocial issues. "Although most states provide funding to support advanced practice nursing and social services to pediatric programs, this support does not exist in the adult health care system except in the most extreme cases. Successful transfer requires not only a smooth takeoff, but also a secure landing. These resources must be developed for at least the 20-something population to ensure continued access to the appropriate health care providers," she said.

"My advice to clinicians is to start before the hormone surge. Preteens are often the most receptive," Dr. Williams suggested. It’s helpful to begin the conversation with the patient and family as soon as possible, and to repeat it often.

Dr. Sable had no financial conflicts to disclose. Cochair Dr. Elyse Foster of the University of California, San Francisco, has received research funding from Boston Scientific, Guidant, and Evalve Inc. Dr. Williams reported that she had no financial disclosures.

Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.

Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).

"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.

The following were the committee’s questions:

• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?

• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?

• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?

• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?

• Does revaccination with any vaccine increase significant harms in patients with AIIRD?

• Is vaccination in patients with AIIRD cost effective?

The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.

Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:

• Assess vaccination status of an AIIRD patient at an initial work-up.

• Vaccinate patients during times of stable disease whenever possible.

• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.

• Strongly consider inactivated flu vaccine for patients with AIIRD.

• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.

• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.

• Consider herpes zoster vaccination in AIIRD patients.

• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).

• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.

• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.

• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.

"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.

In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."

The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.

Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.

Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).

"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.

The following were the committee’s questions:

• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?

• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?

• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?

• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?

• Does revaccination with any vaccine increase significant harms in patients with AIIRD?

• Is vaccination in patients with AIIRD cost effective?

The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.

Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:

• Assess vaccination status of an AIIRD patient at an initial work-up.

• Vaccinate patients during times of stable disease whenever possible.

• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.

• Strongly consider inactivated flu vaccine for patients with AIIRD.

• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.

• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.

• Consider herpes zoster vaccination in AIIRD patients.

• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).

• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.

• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.

• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.

"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.

In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."

The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.

Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.

Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).

"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.

The following were the committee’s questions:

• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?

• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?

• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?

• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?

• Does revaccination with any vaccine increase significant harms in patients with AIIRD?

• Is vaccination in patients with AIIRD cost effective?

The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.

Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:

• Assess vaccination status of an AIIRD patient at an initial work-up.

• Vaccinate patients during times of stable disease whenever possible.

• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.

• Strongly consider inactivated flu vaccine for patients with AIIRD.

• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.

• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.

• Consider herpes zoster vaccination in AIIRD patients.

• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).

• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.

• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.

• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.

"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.

In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."

The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.

Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.

Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).

"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.

The following were the committee’s questions:

• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?

• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?

• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?

• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?

• Does revaccination with any vaccine increase significant harms in patients with AIIRD?

• Is vaccination in patients with AIIRD cost effective?

The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.

Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:

• Assess vaccination status of an AIIRD patient at an initial work-up.

• Vaccinate patients during times of stable disease whenever possible.

• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.

• Strongly consider inactivated flu vaccine for patients with AIIRD.

• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.

• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.

• Consider herpes zoster vaccination in AIIRD patients.

• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).

• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.

• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.

• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.

"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.

In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."

The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.

Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.

Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).

"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.

The following were the committee’s questions:

• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?

• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?

• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?

• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?

• Does revaccination with any vaccine increase significant harms in patients with AIIRD?

• Is vaccination in patients with AIIRD cost effective?

The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.

Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:

• Assess vaccination status of an AIIRD patient at an initial work-up.

• Vaccinate patients during times of stable disease whenever possible.

• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.

• Strongly consider inactivated flu vaccine for patients with AIIRD.

• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.

• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.

• Consider herpes zoster vaccination in AIIRD patients.

• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).

• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.

• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.

• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.

"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.

In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."

The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.

Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.

Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).

"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.

The following were the committee’s questions:

• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?

• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?

• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?

• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?

• Does revaccination with any vaccine increase significant harms in patients with AIIRD?

• Is vaccination in patients with AIIRD cost effective?

The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.

Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:

• Assess vaccination status of an AIIRD patient at an initial work-up.

• Vaccinate patients during times of stable disease whenever possible.

• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.

• Strongly consider inactivated flu vaccine for patients with AIIRD.

• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.

• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.

• Consider herpes zoster vaccination in AIIRD patients.

• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).

• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.

• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.

• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.

"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.

In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."

The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.

Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.

Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).

"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.

The following were the committee’s questions:

• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?

• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?

• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?

• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?

• Does revaccination with any vaccine increase significant harms in patients with AIIRD?

• Is vaccination in patients with AIIRD cost effective?

The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.

Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:

• Assess vaccination status of an AIIRD patient at an initial work-up.

• Vaccinate patients during times of stable disease whenever possible.

• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.

• Strongly consider inactivated flu vaccine for patients with AIIRD.

• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.

• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.

• Consider herpes zoster vaccination in AIIRD patients.

• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).

• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.

• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.

• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.

"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.

In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."

The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.

Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.

Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).

"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.

The following were the committee’s questions:

• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?

• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?

• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?

• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?

• Does revaccination with any vaccine increase significant harms in patients with AIIRD?

• Is vaccination in patients with AIIRD cost effective?

The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.

Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:

• Assess vaccination status of an AIIRD patient at an initial work-up.

• Vaccinate patients during times of stable disease whenever possible.

• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.

• Strongly consider inactivated flu vaccine for patients with AIIRD.

• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.

• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.

• Consider herpes zoster vaccination in AIIRD patients.

• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).

• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.

• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.

• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.

"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.

In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."

The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.

Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.

Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).

"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.

The following were the committee’s questions:

• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?

• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?

• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?

• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?

• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?

• Does revaccination with any vaccine increase significant harms in patients with AIIRD?

• Is vaccination in patients with AIIRD cost effective?

The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.

Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:

• Assess vaccination status of an AIIRD patient at an initial work-up.

• Vaccinate patients during times of stable disease whenever possible.

• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.

• Strongly consider inactivated flu vaccine for patients with AIIRD.

• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.

• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.

• Consider herpes zoster vaccination in AIIRD patients.

• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).

• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.

• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.

• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.

• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.

"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.

In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."

The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.

Contingent screening for prenatal Down syndrome was the most cost-effective stratagem, compared with other screening protocols, based on data from a computer simulation study of 110,948 pregnancies published in the February issue of the American Journal of Obstetrics & Gynecology.

Several screening options are available in Canada and the United States, but data to help clinicians choose among the tests are limited, wrote Dr. Jean Gekas of the Centre Hospitalier de l’Université Laval in Quebec, Canada, and colleagues.

In this study, the researchers used a computer model to analyze a virtual population of 110,948 pregnant women based on the demographic, genetic, and Down syndrome (DS) phenotype characteristics of the local population in Quebec. The tests included in the study were the combined test, triple test, quadruple test, integrated test, serum integrated test, sequential screening test, contingent screening test, and amniocentesis for women aged 35 years and older (Am. J. Obstet. Gynecol. 2011;204:175.e1-8).

"The contingent strategy seems to be the most cost effective and is associated with an attractive rate of procedure-related euploid miscarriages and unnecessary terminations," the researchers wrote. "Moreover, this screening option provides a majority of women with reassurance early in gestation and may minimize costs by limiting retesting."

Overall, the contingent screening test showed a cost-effectiveness ratio of $26,833 Canadian dollars per case of DS. The next most cost-effective test was the serum integrated screening test, but the incremental cost-effectiveness ratio (ICER) between the serum integrated screening and contingent screening tests was $3,815 Canadian dollars for every DS birth detected.

The combined test, currently popular in the United States and Canada, had a slightly higher cost-effectiveness ratio of $47,358 Canadian dollars than does the contingent test, but it allowed 91% of women to be reassured in the first trimester, Dr. Gekas and associates noted.

Similar results on major outcomes including false positives, unnecessary terminations, and DS pregnancies were observed for contingent tests and several other screening tests. But the contingent screening test was associated with one of the lowest rates of procedure-related miscarriages (10). The contingent test also allowed 78% of patients to be reassured in the first trimester.

The combined test was associated with the highest rate of DS pregnancies in the first trimester (90%), and the highest rates of procedure-related euploid miscarriages (71) and unnecessary terminations (24). The combined test was the most expensive of the tests that followed screening strategies, most likely due to the requirement of a nuchal fold transparency test, and the high rate of false positives and subsequent unnecessary terminations associated with it, the researchers said.

The computer model showed that the integrated test had the lowest rate of procedure-related miscarriages. However, widespread use of the integrated test would prevent women from being reassured in the first trimester, the researchers noted.

"Our results should not be used to condemn any current practice of prenatal diagnosis of DS," the researchers said. Cost effectiveness is only part of the picture when choosing a screening strategy for any individual patient. The results suggest that a screening protocol that combines first- and second-trimester evaluation is beneficial for patients. But the findings also raise the question of who would cover the additional costs if tests of varying cost-effectiveness are available, the researchers said.

The study was limited by the lack of prospective data and the potential inability to generalize the results across countries, they said. However, "it is unlikely that a large-scale prospective clinical trial comparing these eight screening approaches could rapidly be organized across North America."

The journal did not provide any disclosure information.

Contingent screening for prenatal Down syndrome was the most cost-effective stratagem, compared with other screening protocols, based on data from a computer simulation study of 110,948 pregnancies published in the February issue of the American Journal of Obstetrics & Gynecology.

Several screening options are available in Canada and the United States, but data to help clinicians choose among the tests are limited, wrote Dr. Jean Gekas of the Centre Hospitalier de l’Université Laval in Quebec, Canada, and colleagues.

In this study, the researchers used a computer model to analyze a virtual population of 110,948 pregnant women based on the demographic, genetic, and Down syndrome (DS) phenotype characteristics of the local population in Quebec. The tests included in the study were the combined test, triple test, quadruple test, integrated test, serum integrated test, sequential screening test, contingent screening test, and amniocentesis for women aged 35 years and older (Am. J. Obstet. Gynecol. 2011;204:175.e1-8).

"The contingent strategy seems to be the most cost effective and is associated with an attractive rate of procedure-related euploid miscarriages and unnecessary terminations," the researchers wrote. "Moreover, this screening option provides a majority of women with reassurance early in gestation and may minimize costs by limiting retesting."

Overall, the contingent screening test showed a cost-effectiveness ratio of $26,833 Canadian dollars per case of DS. The next most cost-effective test was the serum integrated screening test, but the incremental cost-effectiveness ratio (ICER) between the serum integrated screening and contingent screening tests was $3,815 Canadian dollars for every DS birth detected.

The combined test, currently popular in the United States and Canada, had a slightly higher cost-effectiveness ratio of $47,358 Canadian dollars than does the contingent test, but it allowed 91% of women to be reassured in the first trimester, Dr. Gekas and associates noted.

Similar results on major outcomes including false positives, unnecessary terminations, and DS pregnancies were observed for contingent tests and several other screening tests. But the contingent screening test was associated with one of the lowest rates of procedure-related miscarriages (10). The contingent test also allowed 78% of patients to be reassured in the first trimester.

The combined test was associated with the highest rate of DS pregnancies in the first trimester (90%), and the highest rates of procedure-related euploid miscarriages (71) and unnecessary terminations (24). The combined test was the most expensive of the tests that followed screening strategies, most likely due to the requirement of a nuchal fold transparency test, and the high rate of false positives and subsequent unnecessary terminations associated with it, the researchers said.

The computer model showed that the integrated test had the lowest rate of procedure-related miscarriages. However, widespread use of the integrated test would prevent women from being reassured in the first trimester, the researchers noted.

"Our results should not be used to condemn any current practice of prenatal diagnosis of DS," the researchers said. Cost effectiveness is only part of the picture when choosing a screening strategy for any individual patient. The results suggest that a screening protocol that combines first- and second-trimester evaluation is beneficial for patients. But the findings also raise the question of who would cover the additional costs if tests of varying cost-effectiveness are available, the researchers said.

The study was limited by the lack of prospective data and the potential inability to generalize the results across countries, they said. However, "it is unlikely that a large-scale prospective clinical trial comparing these eight screening approaches could rapidly be organized across North America."

The journal did not provide any disclosure information.

Contingent screening for prenatal Down syndrome was the most cost-effective stratagem, compared with other screening protocols, based on data from a computer simulation study of 110,948 pregnancies published in the February issue of the American Journal of Obstetrics & Gynecology.

Several screening options are available in Canada and the United States, but data to help clinicians choose among the tests are limited, wrote Dr. Jean Gekas of the Centre Hospitalier de l’Université Laval in Quebec, Canada, and colleagues.

In this study, the researchers used a computer model to analyze a virtual population of 110,948 pregnant women based on the demographic, genetic, and Down syndrome (DS) phenotype characteristics of the local population in Quebec. The tests included in the study were the combined test, triple test, quadruple test, integrated test, serum integrated test, sequential screening test, contingent screening test, and amniocentesis for women aged 35 years and older (Am. J. Obstet. Gynecol. 2011;204:175.e1-8).

"The contingent strategy seems to be the most cost effective and is associated with an attractive rate of procedure-related euploid miscarriages and unnecessary terminations," the researchers wrote. "Moreover, this screening option provides a majority of women with reassurance early in gestation and may minimize costs by limiting retesting."

Overall, the contingent screening test showed a cost-effectiveness ratio of $26,833 Canadian dollars per case of DS. The next most cost-effective test was the serum integrated screening test, but the incremental cost-effectiveness ratio (ICER) between the serum integrated screening and contingent screening tests was $3,815 Canadian dollars for every DS birth detected.

The combined test, currently popular in the United States and Canada, had a slightly higher cost-effectiveness ratio of $47,358 Canadian dollars than does the contingent test, but it allowed 91% of women to be reassured in the first trimester, Dr. Gekas and associates noted.

Similar results on major outcomes including false positives, unnecessary terminations, and DS pregnancies were observed for contingent tests and several other screening tests. But the contingent screening test was associated with one of the lowest rates of procedure-related miscarriages (10). The contingent test also allowed 78% of patients to be reassured in the first trimester.

The combined test was associated with the highest rate of DS pregnancies in the first trimester (90%), and the highest rates of procedure-related euploid miscarriages (71) and unnecessary terminations (24). The combined test was the most expensive of the tests that followed screening strategies, most likely due to the requirement of a nuchal fold transparency test, and the high rate of false positives and subsequent unnecessary terminations associated with it, the researchers said.

The computer model showed that the integrated test had the lowest rate of procedure-related miscarriages. However, widespread use of the integrated test would prevent women from being reassured in the first trimester, the researchers noted.

"Our results should not be used to condemn any current practice of prenatal diagnosis of DS," the researchers said. Cost effectiveness is only part of the picture when choosing a screening strategy for any individual patient. The results suggest that a screening protocol that combines first- and second-trimester evaluation is beneficial for patients. But the findings also raise the question of who would cover the additional costs if tests of varying cost-effectiveness are available, the researchers said.

The study was limited by the lack of prospective data and the potential inability to generalize the results across countries, they said. However, "it is unlikely that a large-scale prospective clinical trial comparing these eight screening approaches could rapidly be organized across North America."

The journal did not provide any disclosure information.

The direct thrombin inhibitor dabigatran can be used in atrial fibrillation patients as an alternative to warfarin, according to updated guidelines from the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society. The update was published online Feb. 14 in Circulation.

[Dabigatran, Rivaroxaban Vie as Warfarin Alternatives]

The guideline writing committee, which issued a focused update in December (Circulation 2011;123:104-23), noted that the approval of dabigatran by the Food and Drug Administration in October 2010 occurred too late for consideration.

The update to the guidelines summarizes the evidence supporting the FDA approval of dabigatran etexilate to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial – a noninferiority study of 18,113 patients with nonvalvular atrial fibrillation and at least one other risk factor for stroke – 150 mg of dabigatran twice daily reduced the risk of all types of stroke or systemic embolism by 34%. The average age of the patients in the study was 71 years.

Two dosing regimens (110 mg twice daily or 150 mg twice daily) were evaluated, and the 110-mg dose of dabigatran was noninferior to warfarin for the prevention of stroke or systemic embolism. The 110-mg dose of dabigatran was associated with significantly lower rates of major bleeding than was warfarin, and the rate of major bleeding at the 150-mg dose was noninferior to warfarin. Myocardial infarction was more common in dabigatran patients compared with warfarin patients, but the difference was not significant. The 110-mg dosage was not approved, however; the dosage for all patients except those with severe renal impairment is 150 mg twice daily.

Dr. L. Samuel Wann, a cardiologist at Wheaton Franciscan Healthcare in Wauwatosa, Wis., and chair of the 2011 Writing Group, and colleagues noted that dabigatran is not the best choice for all patients, given the twice-daily dosing regimen and increased risk of side effects. However, patients with atrial fibrillation and at least one additional risk factor for stroke might benefit from dabigatran depending on factors including cost, patient preferences, ability to comply with twice-daily dosing, and availability of an anticoagulation management program to help with routine maintenance, the reviewers wrote (Circulation 2011 Feb. 14 [doi:10.1161/CIR.0b013e31820f14c0]).

[FDA Panel Votes to Approve Dabigatran for Reduction of Stroke Risk]

Dr. Wann had no financial conflicts to disclose. Several of the writing group members disclosed serving as a speaker or consultant for, or receiving research funding from, multiple pharmaceutical companies including Medtronic, Boston Scientific, AstraZeneca, Sanofi-Aventis, and GlaxoSmithKline, as well as Boehringer Ingelheim, which markets dabigatran as Pradaxa.

The direct thrombin inhibitor dabigatran can be used in atrial fibrillation patients as an alternative to warfarin, according to updated guidelines from the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society. The update was published online Feb. 14 in Circulation.

[Dabigatran, Rivaroxaban Vie as Warfarin Alternatives]

The guideline writing committee, which issued a focused update in December (Circulation 2011;123:104-23), noted that the approval of dabigatran by the Food and Drug Administration in October 2010 occurred too late for consideration.

The update to the guidelines summarizes the evidence supporting the FDA approval of dabigatran etexilate to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial – a noninferiority study of 18,113 patients with nonvalvular atrial fibrillation and at least one other risk factor for stroke – 150 mg of dabigatran twice daily reduced the risk of all types of stroke or systemic embolism by 34%. The average age of the patients in the study was 71 years.

Two dosing regimens (110 mg twice daily or 150 mg twice daily) were evaluated, and the 110-mg dose of dabigatran was noninferior to warfarin for the prevention of stroke or systemic embolism. The 110-mg dose of dabigatran was associated with significantly lower rates of major bleeding than was warfarin, and the rate of major bleeding at the 150-mg dose was noninferior to warfarin. Myocardial infarction was more common in dabigatran patients compared with warfarin patients, but the difference was not significant. The 110-mg dosage was not approved, however; the dosage for all patients except those with severe renal impairment is 150 mg twice daily.

Dr. L. Samuel Wann, a cardiologist at Wheaton Franciscan Healthcare in Wauwatosa, Wis., and chair of the 2011 Writing Group, and colleagues noted that dabigatran is not the best choice for all patients, given the twice-daily dosing regimen and increased risk of side effects. However, patients with atrial fibrillation and at least one additional risk factor for stroke might benefit from dabigatran depending on factors including cost, patient preferences, ability to comply with twice-daily dosing, and availability of an anticoagulation management program to help with routine maintenance, the reviewers wrote (Circulation 2011 Feb. 14 [doi:10.1161/CIR.0b013e31820f14c0]).

[FDA Panel Votes to Approve Dabigatran for Reduction of Stroke Risk]

Dr. Wann had no financial conflicts to disclose. Several of the writing group members disclosed serving as a speaker or consultant for, or receiving research funding from, multiple pharmaceutical companies including Medtronic, Boston Scientific, AstraZeneca, Sanofi-Aventis, and GlaxoSmithKline, as well as Boehringer Ingelheim, which markets dabigatran as Pradaxa.

The direct thrombin inhibitor dabigatran can be used in atrial fibrillation patients as an alternative to warfarin, according to updated guidelines from the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society. The update was published online Feb. 14 in Circulation.

[Dabigatran, Rivaroxaban Vie as Warfarin Alternatives]

The guideline writing committee, which issued a focused update in December (Circulation 2011;123:104-23), noted that the approval of dabigatran by the Food and Drug Administration in October 2010 occurred too late for consideration.

The update to the guidelines summarizes the evidence supporting the FDA approval of dabigatran etexilate to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial – a noninferiority study of 18,113 patients with nonvalvular atrial fibrillation and at least one other risk factor for stroke – 150 mg of dabigatran twice daily reduced the risk of all types of stroke or systemic embolism by 34%. The average age of the patients in the study was 71 years.

Two dosing regimens (110 mg twice daily or 150 mg twice daily) were evaluated, and the 110-mg dose of dabigatran was noninferior to warfarin for the prevention of stroke or systemic embolism. The 110-mg dose of dabigatran was associated with significantly lower rates of major bleeding than was warfarin, and the rate of major bleeding at the 150-mg dose was noninferior to warfarin. Myocardial infarction was more common in dabigatran patients compared with warfarin patients, but the difference was not significant. The 110-mg dosage was not approved, however; the dosage for all patients except those with severe renal impairment is 150 mg twice daily.

Dr. L. Samuel Wann, a cardiologist at Wheaton Franciscan Healthcare in Wauwatosa, Wis., and chair of the 2011 Writing Group, and colleagues noted that dabigatran is not the best choice for all patients, given the twice-daily dosing regimen and increased risk of side effects. However, patients with atrial fibrillation and at least one additional risk factor for stroke might benefit from dabigatran depending on factors including cost, patient preferences, ability to comply with twice-daily dosing, and availability of an anticoagulation management program to help with routine maintenance, the reviewers wrote (Circulation 2011 Feb. 14 [doi:10.1161/CIR.0b013e31820f14c0]).

[FDA Panel Votes to Approve Dabigatran for Reduction of Stroke Risk]

Dr. Wann had no financial conflicts to disclose. Several of the writing group members disclosed serving as a speaker or consultant for, or receiving research funding from, multiple pharmaceutical companies including Medtronic, Boston Scientific, AstraZeneca, Sanofi-Aventis, and GlaxoSmithKline, as well as Boehringer Ingelheim, which markets dabigatran as Pradaxa.

The direct thrombin inhibitor dabigatran can be used in atrial fibrillation patients as an alternative to warfarin, according to updated guidelines from the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society. The update was published online Feb. 14 in Circulation.

[Dabigatran, Rivaroxaban Vie as Warfarin Alternatives]

The guideline writing committee, which issued a focused update in December (Circulation 2011;123:104-23), noted that the approval of dabigatran by the Food and Drug Administration in October 2010 occurred too late for consideration.

The update to the guidelines summarizes the evidence supporting the FDA approval of dabigatran etexilate to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial – a noninferiority study of 18,113 patients with nonvalvular atrial fibrillation and at least one other risk factor for stroke – 150 mg of dabigatran twice daily reduced the risk of all types of stroke or systemic embolism by 34%. The average age of the patients in the study was 71 years.

Two dosing regimens (110 mg twice daily or 150 mg twice daily) were evaluated, and the 110-mg dose of dabigatran was noninferior to warfarin for the prevention of stroke or systemic embolism. The 110-mg dose of dabigatran was associated with significantly lower rates of major bleeding than was warfarin, and the rate of major bleeding at the 150-mg dose was noninferior to warfarin. Myocardial infarction was more common in dabigatran patients compared with warfarin patients, but the difference was not significant. The 110-mg dosage was not approved, however; the dosage for all patients except those with severe renal impairment is 150 mg twice daily.

Dr. L. Samuel Wann, a cardiologist at Wheaton Franciscan Healthcare in Wauwatosa, Wis., and chair of the 2011 Writing Group, and colleagues noted that dabigatran is not the best choice for all patients, given the twice-daily dosing regimen and increased risk of side effects. However, patients with atrial fibrillation and at least one additional risk factor for stroke might benefit from dabigatran depending on factors including cost, patient preferences, ability to comply with twice-daily dosing, and availability of an anticoagulation management program to help with routine maintenance, the reviewers wrote (Circulation 2011 Feb. 14 [doi:10.1161/CIR.0b013e31820f14c0]).

[FDA Panel Votes to Approve Dabigatran for Reduction of Stroke Risk]

Dr. Wann had no financial conflicts to disclose. Several of the writing group members disclosed serving as a speaker or consultant for, or receiving research funding from, multiple pharmaceutical companies including Medtronic, Boston Scientific, AstraZeneca, Sanofi-Aventis, and GlaxoSmithKline, as well as Boehringer Ingelheim, which markets dabigatran as Pradaxa.

The direct thrombin inhibitor dabigatran can be used in atrial fibrillation patients as an alternative to warfarin, according to updated guidelines from the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society. The update was published online Feb. 14 in Circulation.

[Dabigatran, Rivaroxaban Vie as Warfarin Alternatives]

The guideline writing committee, which issued a focused update in December (Circulation 2011;123:104-23), noted that the approval of dabigatran by the Food and Drug Administration in October 2010 occurred too late for consideration.

The update to the guidelines summarizes the evidence supporting the FDA approval of dabigatran etexilate to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial – a noninferiority study of 18,113 patients with nonvalvular atrial fibrillation and at least one other risk factor for stroke – 150 mg of dabigatran twice daily reduced the risk of all types of stroke or systemic embolism by 34%. The average age of the patients in the study was 71 years.

Two dosing regimens (110 mg twice daily or 150 mg twice daily) were evaluated, and the 110-mg dose of dabigatran was noninferior to warfarin for the prevention of stroke or systemic embolism. The 110-mg dose of dabigatran was associated with significantly lower rates of major bleeding than was warfarin, and the rate of major bleeding at the 150-mg dose was noninferior to warfarin. Myocardial infarction was more common in dabigatran patients compared with warfarin patients, but the difference was not significant. The 110-mg dosage was not approved, however; the dosage for all patients except those with severe renal impairment is 150 mg twice daily.

Dr. L. Samuel Wann, a cardiologist at Wheaton Franciscan Healthcare in Wauwatosa, Wis., and chair of the 2011 Writing Group, and colleagues noted that dabigatran is not the best choice for all patients, given the twice-daily dosing regimen and increased risk of side effects. However, patients with atrial fibrillation and at least one additional risk factor for stroke might benefit from dabigatran depending on factors including cost, patient preferences, ability to comply with twice-daily dosing, and availability of an anticoagulation management program to help with routine maintenance, the reviewers wrote (Circulation 2011 Feb. 14 [doi:10.1161/CIR.0b013e31820f14c0]).

[FDA Panel Votes to Approve Dabigatran for Reduction of Stroke Risk]

Dr. Wann had no financial conflicts to disclose. Several of the writing group members disclosed serving as a speaker or consultant for, or receiving research funding from, multiple pharmaceutical companies including Medtronic, Boston Scientific, AstraZeneca, Sanofi-Aventis, and GlaxoSmithKline, as well as Boehringer Ingelheim, which markets dabigatran as Pradaxa.

The direct thrombin inhibitor dabigatran can be used in atrial fibrillation patients as an alternative to warfarin, according to updated guidelines from the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society. The update was published online Feb. 14 in Circulation.

[Dabigatran, Rivaroxaban Vie as Warfarin Alternatives]

The guideline writing committee, which issued a focused update in December (Circulation 2011;123:104-23), noted that the approval of dabigatran by the Food and Drug Administration in October 2010 occurred too late for consideration.

The update to the guidelines summarizes the evidence supporting the FDA approval of dabigatran etexilate to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial – a noninferiority study of 18,113 patients with nonvalvular atrial fibrillation and at least one other risk factor for stroke – 150 mg of dabigatran twice daily reduced the risk of all types of stroke or systemic embolism by 34%. The average age of the patients in the study was 71 years.

Two dosing regimens (110 mg twice daily or 150 mg twice daily) were evaluated, and the 110-mg dose of dabigatran was noninferior to warfarin for the prevention of stroke or systemic embolism. The 110-mg dose of dabigatran was associated with significantly lower rates of major bleeding than was warfarin, and the rate of major bleeding at the 150-mg dose was noninferior to warfarin. Myocardial infarction was more common in dabigatran patients compared with warfarin patients, but the difference was not significant. The 110-mg dosage was not approved, however; the dosage for all patients except those with severe renal impairment is 150 mg twice daily.

Dr. L. Samuel Wann, a cardiologist at Wheaton Franciscan Healthcare in Wauwatosa, Wis., and chair of the 2011 Writing Group, and colleagues noted that dabigatran is not the best choice for all patients, given the twice-daily dosing regimen and increased risk of side effects. However, patients with atrial fibrillation and at least one additional risk factor for stroke might benefit from dabigatran depending on factors including cost, patient preferences, ability to comply with twice-daily dosing, and availability of an anticoagulation management program to help with routine maintenance, the reviewers wrote (Circulation 2011 Feb. 14 [doi:10.1161/CIR.0b013e31820f14c0]).

[FDA Panel Votes to Approve Dabigatran for Reduction of Stroke Risk]

Dr. Wann had no financial conflicts to disclose. Several of the writing group members disclosed serving as a speaker or consultant for, or receiving research funding from, multiple pharmaceutical companies including Medtronic, Boston Scientific, AstraZeneca, Sanofi-Aventis, and GlaxoSmithKline, as well as Boehringer Ingelheim, which markets dabigatran as Pradaxa.

WASHINGTON – Approximately 40% of the United States population could have some form of cardiovascular disease by the year 2030, based on data from a prediction model created by the American Heart Association. The findings were published online on Jan. 24 in an American Heart Association policy statement in Circulation.

If there’s a silver lining in these figures, it is that they are projections," Nancy Brown, chief executive officer of the AHA, said at a press conference. However, if current policies and prevention strategies go unchanged, the United States is facing "a cardiovascular crisis of alarming proportions," she said.

The aging U.S. population and the increase in medical spending are the main forces driving the disease prevalence and cost, wrote Dr. Paul Heidenreich, of the VA Palo Alto (Calif.) Health Care System, and colleagues.

Without changes in current prevention and treatment trends, the prevalence of cardiovascular disease in the United States will increase by about 10% over the next 20 years, and direct medical costs of cardiovascular disease will triple, from $273 billion to $818 billion, according to the policy statement.

The AHA statement projects an additional 27 million Americans with hypertension, 8 million with coronary heart disease, 4 million with stroke, and 3 million with heart failure between 2010 and 2030 (Circulation 2011 Jan. 24 [Epub doi: 10.1161/CIR.0b013e31820a55f5]).

According to the projections, hypertension will be the most expensive component of cardiovascular disease (CVD), with an estimated annual direct medical cost of $200 billion by 2030. The estimated direct medical cost for stroke is $96 billion, compared with $28 billion in 2010, but stroke represents the greatest relative increase in costs over the next 20 years (238%).

In addition, the indirect costs of all types of cardiovascular disease could increase by 61% (from $172 billion in 2010 to $276 billion in 2030).

However, previous studies have shown that many CVD cases are preventable, and individuals who maintain a healthy lifestyle and favorable levels of atherosclerotic risk are less likely to develop CVD. "Therefore, a greater focus on prevention may alter these CVD projections in the future," according to the statement.

Guidelines have been shown to have "a substantial impact on prevention and treatment and will be an important tool for limiting the burden of CVD," according to the statement. The AHA, the American College of Cardiology, and other organizations have previously published prevention-oriented CVD guidelines, but the implementation of such guidelines is often slow, the writing group noted.

Other factors that could hamper the improvement of CVD risk factors include a reported shortage of cardiologists, they added. Other shortages exist in nursing, pharmacy, and primary care, all of which are needed for a team approach to preventing CVD.

The take-home message for cardiologists is that they can "expect to see more demand for their services," Dr. Heidenreich said in an interview. In addition, primary care physicians will be seeing more patients with forms of heart disease. But the solution includes increasing the number of health professionals across all fields, not only cardiology, said Dr. Heidenreich. "The whole medical complex is insufficient to meet the demand" of the potential increases in CVD, he emphasized.

But, "through a combination of improved prevention of risk factors, and treatment of established risk factors, the dire projection of the health and economic impact of CVD can be diminished," the statement concluded.

The projections of CVD prevalence were based on data from the National Health and Nutrition Examination Survey (NHANES) from 1999 to 2006 and Census Bureau projections from 2010 to 2030. Projections of direct medical costs of CVD were based on data from the Medical Expenditure Panel Survey from 2001 to 2005. Indirect costs of CVD included lost productivity from morbidity and early mortality.

Dr. Heidenreich, chair of the writing group, had no financial conflicts to disclose. Several members of the writing group disclosed research funding from pharmaceutical companies including Boston Scientific, Eli Lilly and Company, Pfizer, Procter & Gamble, and Medtronic. Some members disclosed serving as consultants or advisory board members to companies including Sanofi-Aventis, Bristol Myers Squibb, and Daiichi Sankyo. Some members of the group received research support from organizations including the National Institutes of Health and the National Heart, Lung and Blood Institute.

WASHINGTON – Approximately 40% of the United States population could have some form of cardiovascular disease by the year 2030, based on data from a prediction model created by the American Heart Association. The findings were published online on Jan. 24 in an American Heart Association policy statement in Circulation.

If there’s a silver lining in these figures, it is that they are projections," Nancy Brown, chief executive officer of the AHA, said at a press conference. However, if current policies and prevention strategies go unchanged, the United States is facing "a cardiovascular crisis of alarming proportions," she said.

The aging U.S. population and the increase in medical spending are the main forces driving the disease prevalence and cost, wrote Dr. Paul Heidenreich, of the VA Palo Alto (Calif.) Health Care System, and colleagues.

Without changes in current prevention and treatment trends, the prevalence of cardiovascular disease in the United States will increase by about 10% over the next 20 years, and direct medical costs of cardiovascular disease will triple, from $273 billion to $818 billion, according to the policy statement.

The AHA statement projects an additional 27 million Americans with hypertension, 8 million with coronary heart disease, 4 million with stroke, and 3 million with heart failure between 2010 and 2030 (Circulation 2011 Jan. 24 [Epub doi: 10.1161/CIR.0b013e31820a55f5]).

According to the projections, hypertension will be the most expensive component of cardiovascular disease (CVD), with an estimated annual direct medical cost of $200 billion by 2030. The estimated direct medical cost for stroke is $96 billion, compared with $28 billion in 2010, but stroke represents the greatest relative increase in costs over the next 20 years (238%).

In addition, the indirect costs of all types of cardiovascular disease could increase by 61% (from $172 billion in 2010 to $276 billion in 2030).

However, previous studies have shown that many CVD cases are preventable, and individuals who maintain a healthy lifestyle and favorable levels of atherosclerotic risk are less likely to develop CVD. "Therefore, a greater focus on prevention may alter these CVD projections in the future," according to the statement.

Guidelines have been shown to have "a substantial impact on prevention and treatment and will be an important tool for limiting the burden of CVD," according to the statement. The AHA, the American College of Cardiology, and other organizations have previously published prevention-oriented CVD guidelines, but the implementation of such guidelines is often slow, the writing group noted.

Other factors that could hamper the improvement of CVD risk factors include a reported shortage of cardiologists, they added. Other shortages exist in nursing, pharmacy, and primary care, all of which are needed for a team approach to preventing CVD.

The take-home message for cardiologists is that they can "expect to see more demand for their services," Dr. Heidenreich said in an interview. In addition, primary care physicians will be seeing more patients with forms of heart disease. But the solution includes increasing the number of health professionals across all fields, not only cardiology, said Dr. Heidenreich. "The whole medical complex is insufficient to meet the demand" of the potential increases in CVD, he emphasized.

But, "through a combination of improved prevention of risk factors, and treatment of established risk factors, the dire projection of the health and economic impact of CVD can be diminished," the statement concluded.

The projections of CVD prevalence were based on data from the National Health and Nutrition Examination Survey (NHANES) from 1999 to 2006 and Census Bureau projections from 2010 to 2030. Projections of direct medical costs of CVD were based on data from the Medical Expenditure Panel Survey from 2001 to 2005. Indirect costs of CVD included lost productivity from morbidity and early mortality.

Dr. Heidenreich, chair of the writing group, had no financial conflicts to disclose. Several members of the writing group disclosed research funding from pharmaceutical companies including Boston Scientific, Eli Lilly and Company, Pfizer, Procter & Gamble, and Medtronic. Some members disclosed serving as consultants or advisory board members to companies including Sanofi-Aventis, Bristol Myers Squibb, and Daiichi Sankyo. Some members of the group received research support from organizations including the National Institutes of Health and the National Heart, Lung and Blood Institute.

WASHINGTON – Approximately 40% of the United States population could have some form of cardiovascular disease by the year 2030, based on data from a prediction model created by the American Heart Association. The findings were published online on Jan. 24 in an American Heart Association policy statement in Circulation.

If there’s a silver lining in these figures, it is that they are projections," Nancy Brown, chief executive officer of the AHA, said at a press conference. However, if current policies and prevention strategies go unchanged, the United States is facing "a cardiovascular crisis of alarming proportions," she said.

The aging U.S. population and the increase in medical spending are the main forces driving the disease prevalence and cost, wrote Dr. Paul Heidenreich, of the VA Palo Alto (Calif.) Health Care System, and colleagues.

Without changes in current prevention and treatment trends, the prevalence of cardiovascular disease in the United States will increase by about 10% over the next 20 years, and direct medical costs of cardiovascular disease will triple, from $273 billion to $818 billion, according to the policy statement.

The AHA statement projects an additional 27 million Americans with hypertension, 8 million with coronary heart disease, 4 million with stroke, and 3 million with heart failure between 2010 and 2030 (Circulation 2011 Jan. 24 [Epub doi: 10.1161/CIR.0b013e31820a55f5]).

According to the projections, hypertension will be the most expensive component of cardiovascular disease (CVD), with an estimated annual direct medical cost of $200 billion by 2030. The estimated direct medical cost for stroke is $96 billion, compared with $28 billion in 2010, but stroke represents the greatest relative increase in costs over the next 20 years (238%).

In addition, the indirect costs of all types of cardiovascular disease could increase by 61% (from $172 billion in 2010 to $276 billion in 2030).

However, previous studies have shown that many CVD cases are preventable, and individuals who maintain a healthy lifestyle and favorable levels of atherosclerotic risk are less likely to develop CVD. "Therefore, a greater focus on prevention may alter these CVD projections in the future," according to the statement.

Guidelines have been shown to have "a substantial impact on prevention and treatment and will be an important tool for limiting the burden of CVD," according to the statement. The AHA, the American College of Cardiology, and other organizations have previously published prevention-oriented CVD guidelines, but the implementation of such guidelines is often slow, the writing group noted.

Other factors that could hamper the improvement of CVD risk factors include a reported shortage of cardiologists, they added. Other shortages exist in nursing, pharmacy, and primary care, all of which are needed for a team approach to preventing CVD.

The take-home message for cardiologists is that they can "expect to see more demand for their services," Dr. Heidenreich said in an interview. In addition, primary care physicians will be seeing more patients with forms of heart disease. But the solution includes increasing the number of health professionals across all fields, not only cardiology, said Dr. Heidenreich. "The whole medical complex is insufficient to meet the demand" of the potential increases in CVD, he emphasized.

But, "through a combination of improved prevention of risk factors, and treatment of established risk factors, the dire projection of the health and economic impact of CVD can be diminished," the statement concluded.

The projections of CVD prevalence were based on data from the National Health and Nutrition Examination Survey (NHANES) from 1999 to 2006 and Census Bureau projections from 2010 to 2030. Projections of direct medical costs of CVD were based on data from the Medical Expenditure Panel Survey from 2001 to 2005. Indirect costs of CVD included lost productivity from morbidity and early mortality.

Dr. Heidenreich, chair of the writing group, had no financial conflicts to disclose. Several members of the writing group disclosed research funding from pharmaceutical companies including Boston Scientific, Eli Lilly and Company, Pfizer, Procter & Gamble, and Medtronic. Some members disclosed serving as consultants or advisory board members to companies including Sanofi-Aventis, Bristol Myers Squibb, and Daiichi Sankyo. Some members of the group received research support from organizations including the National Institutes of Health and the National Heart, Lung and Blood Institute.

Approximately 68 million American adults have high blood pressure and 71 million have high cholesterol, and the conditions are uncontrolled in 37 million and 48 million, respectively, according to a Vital Signs report released by the Centers for Disease Control and Prevention.

"Heart disease is the leading killer in America, and the bottom line is that high blood pressure and high cholesterol are out of control for most Americans who have these conditions," CDC director Dr. Thomas R. Frieden said during a teleconference accompanying the report's release.

High blood pressure and high cholesterol remain top risk factors for life-threatening conditions including strokes, heart attacks, and vascular diseases, he added.

Dr. Frieden had a message for physicians: Controlling high blood pressure and cholesterol is one of the most important things you can do for your patients. Know how many of your patients have high blood pressure and high cholesterol, what proportion are controlled, and what can be done to help more patients get these conditions under control, he said.

"We have seen many examples of health systems, health programs, and doctors' offices using information technology to support patients and drastically improve the levels of control, and that's something that is needed throughout health care in this country," he added.

The report was based on data from the National Health and Nutrition Examination Survey (NHANES) on adults aged 18 years and older. The findings also indicate that approximately 20 million U.S. adults with high blood pressure and 37 million with high cholesterol are not being treated for these conditions.

The prevalence of control of high blood pressure was 29% among adults without health insurance, and the control of high cholesterol was less than 15% among those with limited access to health care. But at least 80% of individuals with uncontrolled high blood pressure and high cholesterol have health insurance, Dr. Frieden noted.

For those with health insurance, the characteristics of their specific plan are more likely to affect how likely they are to have high blood pressure or high cholesterol under control than are their personal characteristics, he said.

High blood pressure was defined as blood pressure greater than 140/90 mmHg or reported use of blood pressure–lowering medication. The national prevalence of high blood pressure remained stable over the past decade, although 70% of those with hypertension were being treated and 46% were being controlled, according to the report.

The criteria for high cholesterol included anyone taking cholesterol medication or having a LDL cholesterol level of 100 mg/dL or higher for high-risk individuals, 130 mg/dL or higher for intermediate-risk individuals, and 160 mg/dL for those at low risk.

The proportion of adults treated for high cholesterol increased from 28% to 48% over the past decade, and the proportion of those controlling their high cholesterol increased from less than 20% to more than 30%.

The findings were limited by the lack of data on individuals in nursing homes and other institutions that are not included in NHANES databases, the CDC researchers noted in the report.

"About 100,000 deaths [in the U.S.] are preventable by simple, low-cost improvements in our ability to control high blood pressure and high cholesterol," said Dr. Frieden. "Better control can save lives and save money."

The report is available online at www.cdc.gov/vitalsigns. More detailed information can be found in the Feb. 1 issue of the weekly Morbidity and Mortality Report (MMWR early release/vol. 60; Feb. 1, 2011).

Approximately 68 million American adults have high blood pressure and 71 million have high cholesterol, and the conditions are uncontrolled in 37 million and 48 million, respectively, according to a Vital Signs report released by the Centers for Disease Control and Prevention.

"Heart disease is the leading killer in America, and the bottom line is that high blood pressure and high cholesterol are out of control for most Americans who have these conditions," CDC director Dr. Thomas R. Frieden said during a teleconference accompanying the report's release.

High blood pressure and high cholesterol remain top risk factors for life-threatening conditions including strokes, heart attacks, and vascular diseases, he added.

Dr. Frieden had a message for physicians: Controlling high blood pressure and cholesterol is one of the most important things you can do for your patients. Know how many of your patients have high blood pressure and high cholesterol, what proportion are controlled, and what can be done to help more patients get these conditions under control, he said.

"We have seen many examples of health systems, health programs, and doctors' offices using information technology to support patients and drastically improve the levels of control, and that's something that is needed throughout health care in this country," he added.

The report was based on data from the National Health and Nutrition Examination Survey (NHANES) on adults aged 18 years and older. The findings also indicate that approximately 20 million U.S. adults with high blood pressure and 37 million with high cholesterol are not being treated for these conditions.

The prevalence of control of high blood pressure was 29% among adults without health insurance, and the control of high cholesterol was less than 15% among those with limited access to health care. But at least 80% of individuals with uncontrolled high blood pressure and high cholesterol have health insurance, Dr. Frieden noted.

For those with health insurance, the characteristics of their specific plan are more likely to affect how likely they are to have high blood pressure or high cholesterol under control than are their personal characteristics, he said.

High blood pressure was defined as blood pressure greater than 140/90 mmHg or reported use of blood pressure–lowering medication. The national prevalence of high blood pressure remained stable over the past decade, although 70% of those with hypertension were being treated and 46% were being controlled, according to the report.

The criteria for high cholesterol included anyone taking cholesterol medication or having a LDL cholesterol level of 100 mg/dL or higher for high-risk individuals, 130 mg/dL or higher for intermediate-risk individuals, and 160 mg/dL for those at low risk.

The proportion of adults treated for high cholesterol increased from 28% to 48% over the past decade, and the proportion of those controlling their high cholesterol increased from less than 20% to more than 30%.

The findings were limited by the lack of data on individuals in nursing homes and other institutions that are not included in NHANES databases, the CDC researchers noted in the report.

"About 100,000 deaths [in the U.S.] are preventable by simple, low-cost improvements in our ability to control high blood pressure and high cholesterol," said Dr. Frieden. "Better control can save lives and save money."

The report is available online at www.cdc.gov/vitalsigns. More detailed information can be found in the Feb. 1 issue of the weekly Morbidity and Mortality Report (MMWR early release/vol. 60; Feb. 1, 2011).

Approximately 68 million American adults have high blood pressure and 71 million have high cholesterol, and the conditions are uncontrolled in 37 million and 48 million, respectively, according to a Vital Signs report released by the Centers for Disease Control and Prevention.

"Heart disease is the leading killer in America, and the bottom line is that high blood pressure and high cholesterol are out of control for most Americans who have these conditions," CDC director Dr. Thomas R. Frieden said during a teleconference accompanying the report's release.

High blood pressure and high cholesterol remain top risk factors for life-threatening conditions including strokes, heart attacks, and vascular diseases, he added.

Dr. Frieden had a message for physicians: Controlling high blood pressure and cholesterol is one of the most important things you can do for your patients. Know how many of your patients have high blood pressure and high cholesterol, what proportion are controlled, and what can be done to help more patients get these conditions under control, he said.

"We have seen many examples of health systems, health programs, and doctors' offices using information technology to support patients and drastically improve the levels of control, and that's something that is needed throughout health care in this country," he added.

The report was based on data from the National Health and Nutrition Examination Survey (NHANES) on adults aged 18 years and older. The findings also indicate that approximately 20 million U.S. adults with high blood pressure and 37 million with high cholesterol are not being treated for these conditions.

The prevalence of control of high blood pressure was 29% among adults without health insurance, and the control of high cholesterol was less than 15% among those with limited access to health care. But at least 80% of individuals with uncontrolled high blood pressure and high cholesterol have health insurance, Dr. Frieden noted.

For those with health insurance, the characteristics of their specific plan are more likely to affect how likely they are to have high blood pressure or high cholesterol under control than are their personal characteristics, he said.

High blood pressure was defined as blood pressure greater than 140/90 mmHg or reported use of blood pressure–lowering medication. The national prevalence of high blood pressure remained stable over the past decade, although 70% of those with hypertension were being treated and 46% were being controlled, according to the report.

The criteria for high cholesterol included anyone taking cholesterol medication or having a LDL cholesterol level of 100 mg/dL or higher for high-risk individuals, 130 mg/dL or higher for intermediate-risk individuals, and 160 mg/dL for those at low risk.

The proportion of adults treated for high cholesterol increased from 28% to 48% over the past decade, and the proportion of those controlling their high cholesterol increased from less than 20% to more than 30%.

The findings were limited by the lack of data on individuals in nursing homes and other institutions that are not included in NHANES databases, the CDC researchers noted in the report.

"About 100,000 deaths [in the U.S.] are preventable by simple, low-cost improvements in our ability to control high blood pressure and high cholesterol," said Dr. Frieden. "Better control can save lives and save money."

The report is available online at www.cdc.gov/vitalsigns. More detailed information can be found in the Feb. 1 issue of the weekly Morbidity and Mortality Report (MMWR early release/vol. 60; Feb. 1, 2011).