Primary Care/Internal Medicine

All adult cancer survivors should be screened for chronic pain at every visit, according to the American Society of Clinical Oncology’s first clinical practice guideline for managing this patient population, published July 25 in the Journal of Clinical Oncology.

An estimated 14 million adults with a history of cancer are living in the United States alone, and the prevalence of chronic pain related to their malignancy is reported to be as high as 40%. Yet most health care providers “haven’t been trained to recognize or treat long-term pain associated with cancer,” Judith A. Paice, PhD, RN, said in a press statement accompanying the release of the new guideline.

Existing guidelines focus on the acute pain of cancer and its treatment, or on acute pain related to advanced cancer, said Dr. Paice, cochair of the expert panel that developed the guideline and research professor of hematology/oncology at Northwestern University, Chicago.

©Thinkstock.com

The chronic pain addressed in the new guideline document can be related to the malignancy itself or to its treatment. Surgery, chemotherapy, hormone therapy, radiation treatment, and stem-cell transplantation can induce dozens of pain-producing complications, including osteonecrosis, bone fractures, peripheral or central nerve damage, fistulas, lymphedema, arthralgias, and myelopathy. The pain can develop months or years after diagnosis, significantly impacting patients’ quality of life well after treatment is completed.

“This guideline will help clinicians identify pain early and develop comprehensive treatment plans using a broad range of approaches,” Dr. Paice said in the statement.

The panel that developed the guideline comprised experts in medical oncology, hematology, pain medicine, palliative care, hospice, radiation oncology, social work, rehabilitation, psychology, and anesthesiology. They performed a systematic review of the literature and based their recommendations on 35 meta-analyses, 9 randomized controlled trials, 19 comparative studies, and expert consensus.

Some key recommendations include the following:

• Screen all survivors of adult cancers for chronic pain using both a physical exam and an in-depth interview that covers physical, functional, psychological, social, and spiritual aspects of pain, as well as the patient’s treatment history and comorbid conditions. The guideline includes a list of 36 common pain syndromes resulting from cancer treatments.

• Monitor patients at every visit for late-onset treatment effects that can produce pain, just as they are monitored for recurrent disease and secondary malignancy. Some cancer survivors may not recognize that their current pain is related to past disease or its treatments, or may consider it an untreatable complication that they have to endure.

• Consider the entire range of pain medicines – not just opioid analgesics – including NSAIDs, acetaminophen, and selected antidepressants and anticonvulsants with analgesic efficacy. The panel noted that some cancer survivors with chronic pain may benefit from other drugs, including muscle relaxants, benzodiazepines, N-methyl-D-aspartate receptor blockers, alpha-2 agonists, and neutraceuticals and botanicals. But they urged caution since the efficacy of these agents has not been fully established.

Consider nonmedical treatments such as physical, occupational, and recreation therapy; exercise; orthotics; ultrasound; massage; acupuncture; cognitive behavioral therapy; relaxation therapy; and TENS or other types of nerve stimulation.

Consider medical cannabis or cannabinoids as an adjuvant but not a first-line pain treatment, being sure to follow specific state regulations.

Consider a trial of opioids only for carefully selected patients who don’t respond to more conservative management. Weigh potential risks against benefits and employ universal precautions to minimize abuse and addiction, and be cautious in coprescribing other centrally-acting agents (J Clin Oncol. 2016 July 25. doi: 10.1200/JCO.2016.68.5206).

The full clinical practice guideline and other clinical tools and resources are available at www.asco.org/chronic-pai-guideline.

The guideline development process was supported by ASCO. Dr. Paice reported having no relevant financial disclosures; some of her associates reported financial ties to industry sources.

All adult cancer survivors should be screened for chronic pain at every visit, according to the American Society of Clinical Oncology’s first clinical practice guideline for managing this patient population, published July 25 in the Journal of Clinical Oncology.

An estimated 14 million adults with a history of cancer are living in the United States alone, and the prevalence of chronic pain related to their malignancy is reported to be as high as 40%. Yet most health care providers “haven’t been trained to recognize or treat long-term pain associated with cancer,” Judith A. Paice, PhD, RN, said in a press statement accompanying the release of the new guideline.

Existing guidelines focus on the acute pain of cancer and its treatment, or on acute pain related to advanced cancer, said Dr. Paice, cochair of the expert panel that developed the guideline and research professor of hematology/oncology at Northwestern University, Chicago.

©Thinkstock.com

The chronic pain addressed in the new guideline document can be related to the malignancy itself or to its treatment. Surgery, chemotherapy, hormone therapy, radiation treatment, and stem-cell transplantation can induce dozens of pain-producing complications, including osteonecrosis, bone fractures, peripheral or central nerve damage, fistulas, lymphedema, arthralgias, and myelopathy. The pain can develop months or years after diagnosis, significantly impacting patients’ quality of life well after treatment is completed.

“This guideline will help clinicians identify pain early and develop comprehensive treatment plans using a broad range of approaches,” Dr. Paice said in the statement.

The panel that developed the guideline comprised experts in medical oncology, hematology, pain medicine, palliative care, hospice, radiation oncology, social work, rehabilitation, psychology, and anesthesiology. They performed a systematic review of the literature and based their recommendations on 35 meta-analyses, 9 randomized controlled trials, 19 comparative studies, and expert consensus.

Some key recommendations include the following:

• Screen all survivors of adult cancers for chronic pain using both a physical exam and an in-depth interview that covers physical, functional, psychological, social, and spiritual aspects of pain, as well as the patient’s treatment history and comorbid conditions. The guideline includes a list of 36 common pain syndromes resulting from cancer treatments.

• Monitor patients at every visit for late-onset treatment effects that can produce pain, just as they are monitored for recurrent disease and secondary malignancy. Some cancer survivors may not recognize that their current pain is related to past disease or its treatments, or may consider it an untreatable complication that they have to endure.

• Consider the entire range of pain medicines – not just opioid analgesics – including NSAIDs, acetaminophen, and selected antidepressants and anticonvulsants with analgesic efficacy. The panel noted that some cancer survivors with chronic pain may benefit from other drugs, including muscle relaxants, benzodiazepines, N-methyl-D-aspartate receptor blockers, alpha-2 agonists, and neutraceuticals and botanicals. But they urged caution since the efficacy of these agents has not been fully established.

Consider nonmedical treatments such as physical, occupational, and recreation therapy; exercise; orthotics; ultrasound; massage; acupuncture; cognitive behavioral therapy; relaxation therapy; and TENS or other types of nerve stimulation.

Consider medical cannabis or cannabinoids as an adjuvant but not a first-line pain treatment, being sure to follow specific state regulations.

Consider a trial of opioids only for carefully selected patients who don’t respond to more conservative management. Weigh potential risks against benefits and employ universal precautions to minimize abuse and addiction, and be cautious in coprescribing other centrally-acting agents (J Clin Oncol. 2016 July 25. doi: 10.1200/JCO.2016.68.5206).

The full clinical practice guideline and other clinical tools and resources are available at www.asco.org/chronic-pai-guideline.

The guideline development process was supported by ASCO. Dr. Paice reported having no relevant financial disclosures; some of her associates reported financial ties to industry sources.

All adult cancer survivors should be screened for chronic pain at every visit, according to the American Society of Clinical Oncology’s first clinical practice guideline for managing this patient population, published July 25 in the Journal of Clinical Oncology.

An estimated 14 million adults with a history of cancer are living in the United States alone, and the prevalence of chronic pain related to their malignancy is reported to be as high as 40%. Yet most health care providers “haven’t been trained to recognize or treat long-term pain associated with cancer,” Judith A. Paice, PhD, RN, said in a press statement accompanying the release of the new guideline.

Existing guidelines focus on the acute pain of cancer and its treatment, or on acute pain related to advanced cancer, said Dr. Paice, cochair of the expert panel that developed the guideline and research professor of hematology/oncology at Northwestern University, Chicago.

©Thinkstock.com

The chronic pain addressed in the new guideline document can be related to the malignancy itself or to its treatment. Surgery, chemotherapy, hormone therapy, radiation treatment, and stem-cell transplantation can induce dozens of pain-producing complications, including osteonecrosis, bone fractures, peripheral or central nerve damage, fistulas, lymphedema, arthralgias, and myelopathy. The pain can develop months or years after diagnosis, significantly impacting patients’ quality of life well after treatment is completed.

“This guideline will help clinicians identify pain early and develop comprehensive treatment plans using a broad range of approaches,” Dr. Paice said in the statement.

The panel that developed the guideline comprised experts in medical oncology, hematology, pain medicine, palliative care, hospice, radiation oncology, social work, rehabilitation, psychology, and anesthesiology. They performed a systematic review of the literature and based their recommendations on 35 meta-analyses, 9 randomized controlled trials, 19 comparative studies, and expert consensus.

Some key recommendations include the following:

• Screen all survivors of adult cancers for chronic pain using both a physical exam and an in-depth interview that covers physical, functional, psychological, social, and spiritual aspects of pain, as well as the patient’s treatment history and comorbid conditions. The guideline includes a list of 36 common pain syndromes resulting from cancer treatments.

• Monitor patients at every visit for late-onset treatment effects that can produce pain, just as they are monitored for recurrent disease and secondary malignancy. Some cancer survivors may not recognize that their current pain is related to past disease or its treatments, or may consider it an untreatable complication that they have to endure.

• Consider the entire range of pain medicines – not just opioid analgesics – including NSAIDs, acetaminophen, and selected antidepressants and anticonvulsants with analgesic efficacy. The panel noted that some cancer survivors with chronic pain may benefit from other drugs, including muscle relaxants, benzodiazepines, N-methyl-D-aspartate receptor blockers, alpha-2 agonists, and neutraceuticals and botanicals. But they urged caution since the efficacy of these agents has not been fully established.

Consider nonmedical treatments such as physical, occupational, and recreation therapy; exercise; orthotics; ultrasound; massage; acupuncture; cognitive behavioral therapy; relaxation therapy; and TENS or other types of nerve stimulation.

Consider medical cannabis or cannabinoids as an adjuvant but not a first-line pain treatment, being sure to follow specific state regulations.

Consider a trial of opioids only for carefully selected patients who don’t respond to more conservative management. Weigh potential risks against benefits and employ universal precautions to minimize abuse and addiction, and be cautious in coprescribing other centrally-acting agents (J Clin Oncol. 2016 July 25. doi: 10.1200/JCO.2016.68.5206).

The full clinical practice guideline and other clinical tools and resources are available at www.asco.org/chronic-pai-guideline.

The guideline development process was supported by ASCO. Dr. Paice reported having no relevant financial disclosures; some of her associates reported financial ties to industry sources.

The U.S. Department of Health and Human Services and the U.S. Department of Agriculture have released the eighth iteration of the Dietary Guidelines for Americans, a set of recommendations for healthy eating habits Americans should adopt to prevent development of hypertension, heart disease, and type 2 diabetes, among other conditions.

The new guidelines, effective through 2020, highlight the importance of eating a wide variety of fruits, vegetables, grains, and dairy products, while staying away from processed foods heavy in saturated fats, sugar, and cholesterol as much as possible. The difference between this and earlier editions of the guidelines, the health agencies say, is to promote the importance of a wider variety of foods Americans should be consuming, rather than focusing on just a few isolated foods that should be integrated into an otherwise inadequate diet.

Courtesy of National Cancer Institute

“Protecting the health of the American public includes empowering them with the tools they need to make healthy choices in their daily lives,” Secretary of Health and Human Services Sylvia M. Burwell said in a statement. “By focusing on small shifts in what we eat and drink, eating healthy becomes more manageable. The Dietary Guidelines provide science-based recommendations on food and nutrition so people can make decisions that may help keep their weight under control, and prevent chronic conditions, like Type 2 diabetes, hypertension, and heart disease.”

The American Medical Association voiced their support of the new guidelines, saying that they are “extremely pleased that the new recommendations call for significantly reducing the amount of added sugars and sugar sweetened beverages from the American diet.” Similarly, the American College of Cardiology issued a statement saying that the existence of “a source of clear science-based information about diet” is more important than ever for Americans in the face of increasingly omnipresent and often confusing information available; the college also lauded the recommendations to limit the intake of added sugars, saturated and trans fats, and sodium. The American Heart Association released a new Authoritative Review of data on the topic of nutritional balance as it related to chronic diseases.

While the recommendations may seem common sense and geared more towards patients and laymen, they are of equal importance to health care providers. Dr. Carolyn Lopez – a Chicago-area family physician and adjunct professor of medicine at Northwestern University – called the guidelines an important resource for physicians, with several elements that will be of particular benefit to physicians and clinicians looking to improve the quality of care given to their patients.

“People [should] understand that while individual food choices are important, the pattern of eating is paramount,” Dr. Lopez explained in an interview. “It’s not impossible to bring vegetables into breakfast – veggie omelettes are great – but it’s hard to imagine bringing a vegetable into the whole grain cereals with skim milk breakfast.”

As a family practitioner, however, Dr. Lopez stressed the difficulty of any doctor having a significant enough amount of time with each patient to really go in-depth into what needs to be done to enact meaningful nutritional and lifestyle changes. “These guidelines can only be effective if the whole team is talking to patients,” she explained. “On its own, it would be extraordinarily difficult [or] impossible to accomplish.

Dr. Nazrat Mirza, a pediatrician who is medical director of the IDEAL Pediatric Weight Management Clinic at Children’s National Health System, Washington, said in an interview that the guidelines are “significant in that they are leading us even closer to healthier dietary living – and from my pediatric perspective, healthier children who will grow into healthier adults. We must keep in mind that these guidelines are not prescriptive – but generalized to relatively healthy people. In particular, the recommendation to reduce sugar intake with specification of an upper limit of 10% of calories from added sugar factored into the suggested daily nutritional intake is an excellent update. Added sugar consumption is linked to diabetes, so any reduction in recommended intake will steer people away from potentially developing diabetes.”

She continued, “In my clinic and day-to-day counseling of patients, being able to point to helpful resources such as these guidelines is crucial. These guidelines will continue to serve as yet another way to reach parents and affect the daily dietary habits they practice at home. I was happy to see resources such as MyPlate.gov referenced in the guidelines; that is a tool I use regularly. When educating families on what a healthy plate looks like, I’m able to point directly to the MyPlate.gov posters hanging in the clinic. Comprehensive resources such as these guidelines, [which] give parents actual examples of foods, and deliver the information in a clear, concise, implementable way, are the best methods to reach parents and kids.” 

“As a medical provider, such guidelines provide us with tools and reinforcement to say ‘this is policy,’ when approaching schools about the food and drink options they offer children on a daily basis – because the schools are going to have to follow these guidelines. If these guidelines can enforce public policy for the kids to eat healthy, ... and we can implement changes according to the guidelines, that would help greatly in the prevention of chronic disorders such as obesity, hypertension and diabetes – which is a step in the right direction,” said Dr. Mirza, also of George Washington University, Washington.

“Most physicians are so rushed nowadays by the health care system that they typically do not have adequate time to discuss these very important issues,” Dr. Rodbard said in an interview. “It takes time and perseverance to educate the patient and provide individualized care, assessing their current diet, assessing their willingness or potential for changing their diet or increasing their physical activity.”

On that last point. Dr. Rodbard criticized the new guidelines for not emphasizing the importance of exercise enough. “More clarity and emphasis on physical activity should have been provided,” she said, adding that “people need continual, gentle reminders with repetition and long-term follow-up.” Dr. Rodbard summed up the guidelines as “marginally adequate” but “a step in the right direction.”

An endocrinologist who practices in Winter Park, Fla., Dr. Victor L. Roberts – a Fellow of the ACP and ACE – agreed that time with the patients is critical in order for these guidelines to have any effect, calling the guidelines “just the GPS, not the destination.”

Preaching an ABC strategy – accountability, behavior, and calories, the latter of which he stressed is the most important part of any dietary strategy – Dr. Roberts explained that clinicians and physicians should leave the more specific dietary advice to nutritional experts and focus on telling their patients to watch calories, watch the amount of food they’re eating of any given type, and to exercise more.

“These guidelines crystallize and summarize what we’ve already known, and what we should have been practicing and advocating, for decades,” Dr. Roberts said in an interview, adding that “the difficulty is putting these recommendations into practice and having patients and doctors accept responsibility.”

Ultimately, the three doctors who treat adult patients concurred that the new guidelines are imperfect, and likely won’t result in any automatic widespread change. Dr. Rodbard admitted that she does not anticipate the guidelines affecting the way she treats her patients very much, if at all, while Dr. Lopez said that she’s “not sure it’s going to have a major effect.” Furthermore, the sheer volume of data and information available often leads to patients simply not knowing what to believe, which Dr. Roberts described as a “glazed over” effect of being told so many different things from so many different sources, patients just tune everything out.

Ultimately, while it’s important for health care providers to give advice and recommendations as necessary, these should be done on an individual basis. And, if a patient requires extensive dietary and nutritional intervention, that should be left in the hands of specialist who can accurately determine what the patient is capable of, what their goals should be, and how to tailor a plan specifically for them.

“I don’t know many clinicians, even in my own specialty, who know much about what specifically to eat,” said Dr. Roberts. “That should come from nutritional medicine people, not us.”

Dr. Lopez, Dr. Rodbard, and Dr. Roberts did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

*This article was updated 1/12/2016.

The U.S. Department of Health and Human Services and the U.S. Department of Agriculture have released the eighth iteration of the Dietary Guidelines for Americans, a set of recommendations for healthy eating habits Americans should adopt to prevent development of hypertension, heart disease, and type 2 diabetes, among other conditions.

The new guidelines, effective through 2020, highlight the importance of eating a wide variety of fruits, vegetables, grains, and dairy products, while staying away from processed foods heavy in saturated fats, sugar, and cholesterol as much as possible. The difference between this and earlier editions of the guidelines, the health agencies say, is to promote the importance of a wider variety of foods Americans should be consuming, rather than focusing on just a few isolated foods that should be integrated into an otherwise inadequate diet.

Courtesy of National Cancer Institute

“Protecting the health of the American public includes empowering them with the tools they need to make healthy choices in their daily lives,” Secretary of Health and Human Services Sylvia M. Burwell said in a statement. “By focusing on small shifts in what we eat and drink, eating healthy becomes more manageable. The Dietary Guidelines provide science-based recommendations on food and nutrition so people can make decisions that may help keep their weight under control, and prevent chronic conditions, like Type 2 diabetes, hypertension, and heart disease.”

The American Medical Association voiced their support of the new guidelines, saying that they are “extremely pleased that the new recommendations call for significantly reducing the amount of added sugars and sugar sweetened beverages from the American diet.” Similarly, the American College of Cardiology issued a statement saying that the existence of “a source of clear science-based information about diet” is more important than ever for Americans in the face of increasingly omnipresent and often confusing information available; the college also lauded the recommendations to limit the intake of added sugars, saturated and trans fats, and sodium. The American Heart Association released a new Authoritative Review of data on the topic of nutritional balance as it related to chronic diseases.

While the recommendations may seem common sense and geared more towards patients and laymen, they are of equal importance to health care providers. Dr. Carolyn Lopez – a Chicago-area family physician and adjunct professor of medicine at Northwestern University – called the guidelines an important resource for physicians, with several elements that will be of particular benefit to physicians and clinicians looking to improve the quality of care given to their patients.

“People [should] understand that while individual food choices are important, the pattern of eating is paramount,” Dr. Lopez explained in an interview. “It’s not impossible to bring vegetables into breakfast – veggie omelettes are great – but it’s hard to imagine bringing a vegetable into the whole grain cereals with skim milk breakfast.”

As a family practitioner, however, Dr. Lopez stressed the difficulty of any doctor having a significant enough amount of time with each patient to really go in-depth into what needs to be done to enact meaningful nutritional and lifestyle changes. “These guidelines can only be effective if the whole team is talking to patients,” she explained. “On its own, it would be extraordinarily difficult [or] impossible to accomplish.

Dr. Nazrat Mirza, a pediatrician who is medical director of the IDEAL Pediatric Weight Management Clinic at Children’s National Health System, Washington, said in an interview that the guidelines are “significant in that they are leading us even closer to healthier dietary living – and from my pediatric perspective, healthier children who will grow into healthier adults. We must keep in mind that these guidelines are not prescriptive – but generalized to relatively healthy people. In particular, the recommendation to reduce sugar intake with specification of an upper limit of 10% of calories from added sugar factored into the suggested daily nutritional intake is an excellent update. Added sugar consumption is linked to diabetes, so any reduction in recommended intake will steer people away from potentially developing diabetes.”

She continued, “In my clinic and day-to-day counseling of patients, being able to point to helpful resources such as these guidelines is crucial. These guidelines will continue to serve as yet another way to reach parents and affect the daily dietary habits they practice at home. I was happy to see resources such as MyPlate.gov referenced in the guidelines; that is a tool I use regularly. When educating families on what a healthy plate looks like, I’m able to point directly to the MyPlate.gov posters hanging in the clinic. Comprehensive resources such as these guidelines, [which] give parents actual examples of foods, and deliver the information in a clear, concise, implementable way, are the best methods to reach parents and kids.” 

“As a medical provider, such guidelines provide us with tools and reinforcement to say ‘this is policy,’ when approaching schools about the food and drink options they offer children on a daily basis – because the schools are going to have to follow these guidelines. If these guidelines can enforce public policy for the kids to eat healthy, ... and we can implement changes according to the guidelines, that would help greatly in the prevention of chronic disorders such as obesity, hypertension and diabetes – which is a step in the right direction,” said Dr. Mirza, also of George Washington University, Washington.

“Most physicians are so rushed nowadays by the health care system that they typically do not have adequate time to discuss these very important issues,” Dr. Rodbard said in an interview. “It takes time and perseverance to educate the patient and provide individualized care, assessing their current diet, assessing their willingness or potential for changing their diet or increasing their physical activity.”

On that last point. Dr. Rodbard criticized the new guidelines for not emphasizing the importance of exercise enough. “More clarity and emphasis on physical activity should have been provided,” she said, adding that “people need continual, gentle reminders with repetition and long-term follow-up.” Dr. Rodbard summed up the guidelines as “marginally adequate” but “a step in the right direction.”

An endocrinologist who practices in Winter Park, Fla., Dr. Victor L. Roberts – a Fellow of the ACP and ACE – agreed that time with the patients is critical in order for these guidelines to have any effect, calling the guidelines “just the GPS, not the destination.”

Preaching an ABC strategy – accountability, behavior, and calories, the latter of which he stressed is the most important part of any dietary strategy – Dr. Roberts explained that clinicians and physicians should leave the more specific dietary advice to nutritional experts and focus on telling their patients to watch calories, watch the amount of food they’re eating of any given type, and to exercise more.

“These guidelines crystallize and summarize what we’ve already known, and what we should have been practicing and advocating, for decades,” Dr. Roberts said in an interview, adding that “the difficulty is putting these recommendations into practice and having patients and doctors accept responsibility.”

Ultimately, the three doctors who treat adult patients concurred that the new guidelines are imperfect, and likely won’t result in any automatic widespread change. Dr. Rodbard admitted that she does not anticipate the guidelines affecting the way she treats her patients very much, if at all, while Dr. Lopez said that she’s “not sure it’s going to have a major effect.” Furthermore, the sheer volume of data and information available often leads to patients simply not knowing what to believe, which Dr. Roberts described as a “glazed over” effect of being told so many different things from so many different sources, patients just tune everything out.

Ultimately, while it’s important for health care providers to give advice and recommendations as necessary, these should be done on an individual basis. And, if a patient requires extensive dietary and nutritional intervention, that should be left in the hands of specialist who can accurately determine what the patient is capable of, what their goals should be, and how to tailor a plan specifically for them.

“I don’t know many clinicians, even in my own specialty, who know much about what specifically to eat,” said Dr. Roberts. “That should come from nutritional medicine people, not us.”

Dr. Lopez, Dr. Rodbard, and Dr. Roberts did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

*This article was updated 1/12/2016.

The U.S. Department of Health and Human Services and the U.S. Department of Agriculture have released the eighth iteration of the Dietary Guidelines for Americans, a set of recommendations for healthy eating habits Americans should adopt to prevent development of hypertension, heart disease, and type 2 diabetes, among other conditions.

The new guidelines, effective through 2020, highlight the importance of eating a wide variety of fruits, vegetables, grains, and dairy products, while staying away from processed foods heavy in saturated fats, sugar, and cholesterol as much as possible. The difference between this and earlier editions of the guidelines, the health agencies say, is to promote the importance of a wider variety of foods Americans should be consuming, rather than focusing on just a few isolated foods that should be integrated into an otherwise inadequate diet.

Courtesy of National Cancer Institute

“Protecting the health of the American public includes empowering them with the tools they need to make healthy choices in their daily lives,” Secretary of Health and Human Services Sylvia M. Burwell said in a statement. “By focusing on small shifts in what we eat and drink, eating healthy becomes more manageable. The Dietary Guidelines provide science-based recommendations on food and nutrition so people can make decisions that may help keep their weight under control, and prevent chronic conditions, like Type 2 diabetes, hypertension, and heart disease.”

The American Medical Association voiced their support of the new guidelines, saying that they are “extremely pleased that the new recommendations call for significantly reducing the amount of added sugars and sugar sweetened beverages from the American diet.” Similarly, the American College of Cardiology issued a statement saying that the existence of “a source of clear science-based information about diet” is more important than ever for Americans in the face of increasingly omnipresent and often confusing information available; the college also lauded the recommendations to limit the intake of added sugars, saturated and trans fats, and sodium. The American Heart Association released a new Authoritative Review of data on the topic of nutritional balance as it related to chronic diseases.

While the recommendations may seem common sense and geared more towards patients and laymen, they are of equal importance to health care providers. Dr. Carolyn Lopez – a Chicago-area family physician and adjunct professor of medicine at Northwestern University – called the guidelines an important resource for physicians, with several elements that will be of particular benefit to physicians and clinicians looking to improve the quality of care given to their patients.

“People [should] understand that while individual food choices are important, the pattern of eating is paramount,” Dr. Lopez explained in an interview. “It’s not impossible to bring vegetables into breakfast – veggie omelettes are great – but it’s hard to imagine bringing a vegetable into the whole grain cereals with skim milk breakfast.”

As a family practitioner, however, Dr. Lopez stressed the difficulty of any doctor having a significant enough amount of time with each patient to really go in-depth into what needs to be done to enact meaningful nutritional and lifestyle changes. “These guidelines can only be effective if the whole team is talking to patients,” she explained. “On its own, it would be extraordinarily difficult [or] impossible to accomplish.

Dr. Nazrat Mirza, a pediatrician who is medical director of the IDEAL Pediatric Weight Management Clinic at Children’s National Health System, Washington, said in an interview that the guidelines are “significant in that they are leading us even closer to healthier dietary living – and from my pediatric perspective, healthier children who will grow into healthier adults. We must keep in mind that these guidelines are not prescriptive – but generalized to relatively healthy people. In particular, the recommendation to reduce sugar intake with specification of an upper limit of 10% of calories from added sugar factored into the suggested daily nutritional intake is an excellent update. Added sugar consumption is linked to diabetes, so any reduction in recommended intake will steer people away from potentially developing diabetes.”

She continued, “In my clinic and day-to-day counseling of patients, being able to point to helpful resources such as these guidelines is crucial. These guidelines will continue to serve as yet another way to reach parents and affect the daily dietary habits they practice at home. I was happy to see resources such as MyPlate.gov referenced in the guidelines; that is a tool I use regularly. When educating families on what a healthy plate looks like, I’m able to point directly to the MyPlate.gov posters hanging in the clinic. Comprehensive resources such as these guidelines, [which] give parents actual examples of foods, and deliver the information in a clear, concise, implementable way, are the best methods to reach parents and kids.” 

“As a medical provider, such guidelines provide us with tools and reinforcement to say ‘this is policy,’ when approaching schools about the food and drink options they offer children on a daily basis – because the schools are going to have to follow these guidelines. If these guidelines can enforce public policy for the kids to eat healthy, ... and we can implement changes according to the guidelines, that would help greatly in the prevention of chronic disorders such as obesity, hypertension and diabetes – which is a step in the right direction,” said Dr. Mirza, also of George Washington University, Washington.

“Most physicians are so rushed nowadays by the health care system that they typically do not have adequate time to discuss these very important issues,” Dr. Rodbard said in an interview. “It takes time and perseverance to educate the patient and provide individualized care, assessing their current diet, assessing their willingness or potential for changing their diet or increasing their physical activity.”

On that last point. Dr. Rodbard criticized the new guidelines for not emphasizing the importance of exercise enough. “More clarity and emphasis on physical activity should have been provided,” she said, adding that “people need continual, gentle reminders with repetition and long-term follow-up.” Dr. Rodbard summed up the guidelines as “marginally adequate” but “a step in the right direction.”

An endocrinologist who practices in Winter Park, Fla., Dr. Victor L. Roberts – a Fellow of the ACP and ACE – agreed that time with the patients is critical in order for these guidelines to have any effect, calling the guidelines “just the GPS, not the destination.”

Preaching an ABC strategy – accountability, behavior, and calories, the latter of which he stressed is the most important part of any dietary strategy – Dr. Roberts explained that clinicians and physicians should leave the more specific dietary advice to nutritional experts and focus on telling their patients to watch calories, watch the amount of food they’re eating of any given type, and to exercise more.

“These guidelines crystallize and summarize what we’ve already known, and what we should have been practicing and advocating, for decades,” Dr. Roberts said in an interview, adding that “the difficulty is putting these recommendations into practice and having patients and doctors accept responsibility.”

Ultimately, the three doctors who treat adult patients concurred that the new guidelines are imperfect, and likely won’t result in any automatic widespread change. Dr. Rodbard admitted that she does not anticipate the guidelines affecting the way she treats her patients very much, if at all, while Dr. Lopez said that she’s “not sure it’s going to have a major effect.” Furthermore, the sheer volume of data and information available often leads to patients simply not knowing what to believe, which Dr. Roberts described as a “glazed over” effect of being told so many different things from so many different sources, patients just tune everything out.

Ultimately, while it’s important for health care providers to give advice and recommendations as necessary, these should be done on an individual basis. And, if a patient requires extensive dietary and nutritional intervention, that should be left in the hands of specialist who can accurately determine what the patient is capable of, what their goals should be, and how to tailor a plan specifically for them.

“I don’t know many clinicians, even in my own specialty, who know much about what specifically to eat,” said Dr. Roberts. “That should come from nutritional medicine people, not us.”

Dr. Lopez, Dr. Rodbard, and Dr. Roberts did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

*This article was updated 1/12/2016.

Updated guidelines regarding the treatment of patients with venous thromboembolism advise abandoning the routine use of compression stockings for prevention of postthrombotic syndrome in patients who have had an acute deep vein thrombosis, according to Dr. Clive Kearon, lead author of the American College of Chest Physicians’ 10th edition of “Antithrombotic Therapy for VTE Disease” (Chest. 2015. doi: 10.1016/j.chest.2015.11.026).

The VTE guidelines include 12 recommendations. Two other key changes from the previous guidelines include new treatment recommendations about which patients with isolated subsegmental pulmonary embolism (PE) should, and should not, receive anticoagulant therapy, and as a recommendation for the use of non–vitamin K antagonist oral anticoagulants (NOACs) instead of warfarin for initial and long-term treatment of VTE in patients without cancer.

It is another of the group’s “living guidelines,” intended to be flexible, easy-to-update recommendations … based on the best available evidence, and to identify gaps in our knowledge and areas for future research,” Dr. Kearon of McMaster University, Hamilton, Ont., said in an interview.

“Clinicians and guideline developers would like clinician decisions to be supported by very strong, or almost irrefutable, evidence,” he said. ”It’s difficult to do studies that provide irrefutable evidence, however,” and most of the updated recommendations are not based on the highest level of study evidence – large, randomized controlled trials.

Nevertheless, “the quality of evidence that supports guidelines and clinical decision making is much better now than it was 20 or 30 years ago,” Dr. Kearon said, mainly because more recent studies are considerably larger and involve multiple clinical centers. Plus, “we’re continually improving our skills at doing high-quality studies and studies that have a low potential for bias.”

The old recommendation to use graduated compression stockings for 2 years after DVT to reduce the risk of postthrombotic syndrome was mainly based on findings of two small single-center randomized trials, published in the Lancet and Annals of Internal Medicine, in which patients and study personnel were not blinded to stocking use. Since then, a much larger multicenter, placebo-controlled trial found that routine use of graduated compression stockings did not reduce postthrombotic syndrome or have other important benefits in 410 patients with a first proximal DVT randomized to receive either active or placebo compression stockings. The incidence of postthrombotic syndrome was 14% in the active group and 13% in the placebo group – a nonsignificant difference. The same study also found that routine use of graduated compression stockings did not reduce leg pain during the 3 months after a DVT – although the stockings were still able to reduce acute symptoms of DVT, and chronic symptoms in patients with postthrombotic syndrome.

The recommendation to replace warfarin with NOACs is based on new data suggesting that the agents are associated with a lower risk of bleeding, and on observations that NOACs are much easier for patients and clinicians to use. Several of the studies upon which earlier guidelines were based have been reanalyzed, Dr. Kearon and his coauthors wrote. There are also now extensive data on the comparative safety of NOACs and warfarin.

“Based on less bleeding with NOACs and greater convenience for patients and health care providers, we now suggest that a NOAC is used in preference to VKA [vitamin K antagonist] for the initial and long-term treatment of VTE in patients without cancer,” they wrote.

The recommendation to employ watchful waiting over anticoagulation in some patients with subsegmental pulmonary embolism is based on a compendium of clinical evidence rather than on large studies. A true subsegmental PE is unlikely to need anticoagulation, because it will have arisen from a small clot and thus carry a small risk of progression or recurrence.

“There is, however, high-quality evidence for the efficacy and safety of anticoagulant therapy in patients with larger PE, and this is expected to apply similarly to patients with subsegmental PE,” the authors wrote. “Whether the risk of progressive or recurrent VTE is high enough to justify anticoagulation in patients with subsegmental PE is uncertain.”

If clinical assessment suggests that anticoagulation isn’t appropriate, these patients should have a confirmatory bilateral ultrasound to rule out proximal DVTs, especially in high-risk locations. If a DVT is detected, clinicians may choose to conduct subsequent ultrasounds to identify and treat any evolving proximal clots.

The guideline has been endorsed by the American Association for Clinical Chemistry, the American College of Clinical Pharmacy, the International Society for Thrombosis and Haemostasis, and the American Society of Health-System Pharmacists.

Dr. Kearon has been compensated for speaking engagements sponsored by Boehringer Ingelheim and Bayer Healthcare related to VTE therapy. Some of the other guideline authors also disclosed relationships with pharmaceutical companies.

msullivan@frontlinemedcom.com

Updated guidelines regarding the treatment of patients with venous thromboembolism advise abandoning the routine use of compression stockings for prevention of postthrombotic syndrome in patients who have had an acute deep vein thrombosis, according to Dr. Clive Kearon, lead author of the American College of Chest Physicians’ 10th edition of “Antithrombotic Therapy for VTE Disease” (Chest. 2015. doi: 10.1016/j.chest.2015.11.026).

The VTE guidelines include 12 recommendations. Two other key changes from the previous guidelines include new treatment recommendations about which patients with isolated subsegmental pulmonary embolism (PE) should, and should not, receive anticoagulant therapy, and as a recommendation for the use of non–vitamin K antagonist oral anticoagulants (NOACs) instead of warfarin for initial and long-term treatment of VTE in patients without cancer.

It is another of the group’s “living guidelines,” intended to be flexible, easy-to-update recommendations … based on the best available evidence, and to identify gaps in our knowledge and areas for future research,” Dr. Kearon of McMaster University, Hamilton, Ont., said in an interview.

“Clinicians and guideline developers would like clinician decisions to be supported by very strong, or almost irrefutable, evidence,” he said. ”It’s difficult to do studies that provide irrefutable evidence, however,” and most of the updated recommendations are not based on the highest level of study evidence – large, randomized controlled trials.

Nevertheless, “the quality of evidence that supports guidelines and clinical decision making is much better now than it was 20 or 30 years ago,” Dr. Kearon said, mainly because more recent studies are considerably larger and involve multiple clinical centers. Plus, “we’re continually improving our skills at doing high-quality studies and studies that have a low potential for bias.”

The old recommendation to use graduated compression stockings for 2 years after DVT to reduce the risk of postthrombotic syndrome was mainly based on findings of two small single-center randomized trials, published in the Lancet and Annals of Internal Medicine, in which patients and study personnel were not blinded to stocking use. Since then, a much larger multicenter, placebo-controlled trial found that routine use of graduated compression stockings did not reduce postthrombotic syndrome or have other important benefits in 410 patients with a first proximal DVT randomized to receive either active or placebo compression stockings. The incidence of postthrombotic syndrome was 14% in the active group and 13% in the placebo group – a nonsignificant difference. The same study also found that routine use of graduated compression stockings did not reduce leg pain during the 3 months after a DVT – although the stockings were still able to reduce acute symptoms of DVT, and chronic symptoms in patients with postthrombotic syndrome.

The recommendation to replace warfarin with NOACs is based on new data suggesting that the agents are associated with a lower risk of bleeding, and on observations that NOACs are much easier for patients and clinicians to use. Several of the studies upon which earlier guidelines were based have been reanalyzed, Dr. Kearon and his coauthors wrote. There are also now extensive data on the comparative safety of NOACs and warfarin.

“Based on less bleeding with NOACs and greater convenience for patients and health care providers, we now suggest that a NOAC is used in preference to VKA [vitamin K antagonist] for the initial and long-term treatment of VTE in patients without cancer,” they wrote.

The recommendation to employ watchful waiting over anticoagulation in some patients with subsegmental pulmonary embolism is based on a compendium of clinical evidence rather than on large studies. A true subsegmental PE is unlikely to need anticoagulation, because it will have arisen from a small clot and thus carry a small risk of progression or recurrence.

“There is, however, high-quality evidence for the efficacy and safety of anticoagulant therapy in patients with larger PE, and this is expected to apply similarly to patients with subsegmental PE,” the authors wrote. “Whether the risk of progressive or recurrent VTE is high enough to justify anticoagulation in patients with subsegmental PE is uncertain.”

If clinical assessment suggests that anticoagulation isn’t appropriate, these patients should have a confirmatory bilateral ultrasound to rule out proximal DVTs, especially in high-risk locations. If a DVT is detected, clinicians may choose to conduct subsequent ultrasounds to identify and treat any evolving proximal clots.

The guideline has been endorsed by the American Association for Clinical Chemistry, the American College of Clinical Pharmacy, the International Society for Thrombosis and Haemostasis, and the American Society of Health-System Pharmacists.

Dr. Kearon has been compensated for speaking engagements sponsored by Boehringer Ingelheim and Bayer Healthcare related to VTE therapy. Some of the other guideline authors also disclosed relationships with pharmaceutical companies.

msullivan@frontlinemedcom.com

Updated guidelines regarding the treatment of patients with venous thromboembolism advise abandoning the routine use of compression stockings for prevention of postthrombotic syndrome in patients who have had an acute deep vein thrombosis, according to Dr. Clive Kearon, lead author of the American College of Chest Physicians’ 10th edition of “Antithrombotic Therapy for VTE Disease” (Chest. 2015. doi: 10.1016/j.chest.2015.11.026).

The VTE guidelines include 12 recommendations. Two other key changes from the previous guidelines include new treatment recommendations about which patients with isolated subsegmental pulmonary embolism (PE) should, and should not, receive anticoagulant therapy, and as a recommendation for the use of non–vitamin K antagonist oral anticoagulants (NOACs) instead of warfarin for initial and long-term treatment of VTE in patients without cancer.

It is another of the group’s “living guidelines,” intended to be flexible, easy-to-update recommendations … based on the best available evidence, and to identify gaps in our knowledge and areas for future research,” Dr. Kearon of McMaster University, Hamilton, Ont., said in an interview.

“Clinicians and guideline developers would like clinician decisions to be supported by very strong, or almost irrefutable, evidence,” he said. ”It’s difficult to do studies that provide irrefutable evidence, however,” and most of the updated recommendations are not based on the highest level of study evidence – large, randomized controlled trials.

Nevertheless, “the quality of evidence that supports guidelines and clinical decision making is much better now than it was 20 or 30 years ago,” Dr. Kearon said, mainly because more recent studies are considerably larger and involve multiple clinical centers. Plus, “we’re continually improving our skills at doing high-quality studies and studies that have a low potential for bias.”

The old recommendation to use graduated compression stockings for 2 years after DVT to reduce the risk of postthrombotic syndrome was mainly based on findings of two small single-center randomized trials, published in the Lancet and Annals of Internal Medicine, in which patients and study personnel were not blinded to stocking use. Since then, a much larger multicenter, placebo-controlled trial found that routine use of graduated compression stockings did not reduce postthrombotic syndrome or have other important benefits in 410 patients with a first proximal DVT randomized to receive either active or placebo compression stockings. The incidence of postthrombotic syndrome was 14% in the active group and 13% in the placebo group – a nonsignificant difference. The same study also found that routine use of graduated compression stockings did not reduce leg pain during the 3 months after a DVT – although the stockings were still able to reduce acute symptoms of DVT, and chronic symptoms in patients with postthrombotic syndrome.

The recommendation to replace warfarin with NOACs is based on new data suggesting that the agents are associated with a lower risk of bleeding, and on observations that NOACs are much easier for patients and clinicians to use. Several of the studies upon which earlier guidelines were based have been reanalyzed, Dr. Kearon and his coauthors wrote. There are also now extensive data on the comparative safety of NOACs and warfarin.

“Based on less bleeding with NOACs and greater convenience for patients and health care providers, we now suggest that a NOAC is used in preference to VKA [vitamin K antagonist] for the initial and long-term treatment of VTE in patients without cancer,” they wrote.

The recommendation to employ watchful waiting over anticoagulation in some patients with subsegmental pulmonary embolism is based on a compendium of clinical evidence rather than on large studies. A true subsegmental PE is unlikely to need anticoagulation, because it will have arisen from a small clot and thus carry a small risk of progression or recurrence.

“There is, however, high-quality evidence for the efficacy and safety of anticoagulant therapy in patients with larger PE, and this is expected to apply similarly to patients with subsegmental PE,” the authors wrote. “Whether the risk of progressive or recurrent VTE is high enough to justify anticoagulation in patients with subsegmental PE is uncertain.”

If clinical assessment suggests that anticoagulation isn’t appropriate, these patients should have a confirmatory bilateral ultrasound to rule out proximal DVTs, especially in high-risk locations. If a DVT is detected, clinicians may choose to conduct subsequent ultrasounds to identify and treat any evolving proximal clots.

The guideline has been endorsed by the American Association for Clinical Chemistry, the American College of Clinical Pharmacy, the International Society for Thrombosis and Haemostasis, and the American Society of Health-System Pharmacists.

Dr. Kearon has been compensated for speaking engagements sponsored by Boehringer Ingelheim and Bayer Healthcare related to VTE therapy. Some of the other guideline authors also disclosed relationships with pharmaceutical companies.

msullivan@frontlinemedcom.com

TORONTO – In atrial fibrillation (AF) patients who must discontinue dabigatran for elective surgery, the risk of both stroke and major bleeding can be reduced to low levels using a formalized strategy for stopping and then restarting anticoagulation, according to results of a prospective study presented at the International Society on Thrombosis and Haemostasis Congress.

Among key findings presented at a press conference at the ISTH 2015 Congress, no strokes were recorded in more than 500 patients managed with the protocol, and the major bleeding rate was less than 2%, reported the study’s principal investigator, Dr. Sam Schulman, professor of hematology and thromboembolism, McMaster University, Hamilton, Ont.

Data from this study (Circulation 2015) were reported at the press conference alongside a second study of perioperative warfarin management. Both studies are potentially practice changing, because they supply evidence-based guidance for anticoagulation in patients with AF.

Courtesy International Society of Thrombosis and Haemostasis

Based on the findings from these two studies, “it is important to get this message out” that there are now data available on which to base clinical decisions, reported Dr. Schulman, who is also president of the ISTH 2015 Congress. His data were presented alongside a study that found no benefit from heparin bridging in AF patients when warfarin was stopped 5 days in advance of surgery.

In the study presented by Dr. Schulman, 542 patients with AF who were on dabigatran and scheduled for elective surgery were managed on a prespecified protocol for risk assessment. The protocol provided a time for stopping dabigatran before surgery based on such factors as renal function and procedure-related bleeding risk. Dabigatran was restarted after surgery on prespecified measures of surgery complexity and severity of consequences if bleeding occurred.

The primary outcome evaluated in the study was major bleeding in the first 30 days. Other outcomes of interest included thromboembolic complications, death and minor bleeding.

Major bleeding was observed in 1.8% of patients, a rate that Dr. Schulman characterized as “low and acceptable” in the context of expected background bleeding rates. There were four deaths, but all were unrelated to either bleeding or arterial thromboembolism. The only thromboembolic complication was a single transient ischemic attack. Minor bleeding occurred in 5.2%.

On the basis of the protocol, about half of the patients discontinued dabigatran 24 hours before surgery. No patient discontinued therapy more than 96 hours prior to surgery. The median time to resumption of dabigatran after surgery was 1 day, but the point at which it was restarted ranged between hours and 2 days. Bridging, which describes the injection of heparin for short-term anticoagulation, was not employed preoperatively but was used in 1.7% of cases postoperatively.

At the press conference, data also were reported from the BRIDGE study. That study, published online in the New England Journal of Medicine (2015 June 22; epub ahead of print ), found that bridging was not an effective strategy in AF patients who discontinue warfarin prior to elective surgery. In the press conference, Dr. Thomas L. Ortel, hematology/oncology division, Duke University Medical Center, Durham, N.C., agreed with Dr. Schulman that this is an area where evidence is needed to guide care.

In the absence of data, “physicians do whatever they think is best,” Dr. Schulman noted at the press conference. Referring to strategies for stopping anticoagulants for surgery in patients with AF, Dr. Schulman said, “some of them stop the blood thinner too early because they are afraid that the patient is going to bleed during surgery and instead the patient can have a stroke. Some stop too late, and the patient can have bleeding.”

The data presented at the meeting provide an evidence base for clinical decisions. Dr. Schulman suggested that these data are meaningful for guiding care.

Dr. Ortel disclosed grant/research support from Eisai and Pfizer. Dr. Schulman had no disclosures.

TORONTO – In atrial fibrillation (AF) patients who must discontinue dabigatran for elective surgery, the risk of both stroke and major bleeding can be reduced to low levels using a formalized strategy for stopping and then restarting anticoagulation, according to results of a prospective study presented at the International Society on Thrombosis and Haemostasis Congress.

Among key findings presented at a press conference at the ISTH 2015 Congress, no strokes were recorded in more than 500 patients managed with the protocol, and the major bleeding rate was less than 2%, reported the study’s principal investigator, Dr. Sam Schulman, professor of hematology and thromboembolism, McMaster University, Hamilton, Ont.

Data from this study (Circulation 2015) were reported at the press conference alongside a second study of perioperative warfarin management. Both studies are potentially practice changing, because they supply evidence-based guidance for anticoagulation in patients with AF.

Courtesy International Society of Thrombosis and Haemostasis

Based on the findings from these two studies, “it is important to get this message out” that there are now data available on which to base clinical decisions, reported Dr. Schulman, who is also president of the ISTH 2015 Congress. His data were presented alongside a study that found no benefit from heparin bridging in AF patients when warfarin was stopped 5 days in advance of surgery.

In the study presented by Dr. Schulman, 542 patients with AF who were on dabigatran and scheduled for elective surgery were managed on a prespecified protocol for risk assessment. The protocol provided a time for stopping dabigatran before surgery based on such factors as renal function and procedure-related bleeding risk. Dabigatran was restarted after surgery on prespecified measures of surgery complexity and severity of consequences if bleeding occurred.

The primary outcome evaluated in the study was major bleeding in the first 30 days. Other outcomes of interest included thromboembolic complications, death and minor bleeding.

Major bleeding was observed in 1.8% of patients, a rate that Dr. Schulman characterized as “low and acceptable” in the context of expected background bleeding rates. There were four deaths, but all were unrelated to either bleeding or arterial thromboembolism. The only thromboembolic complication was a single transient ischemic attack. Minor bleeding occurred in 5.2%.

On the basis of the protocol, about half of the patients discontinued dabigatran 24 hours before surgery. No patient discontinued therapy more than 96 hours prior to surgery. The median time to resumption of dabigatran after surgery was 1 day, but the point at which it was restarted ranged between hours and 2 days. Bridging, which describes the injection of heparin for short-term anticoagulation, was not employed preoperatively but was used in 1.7% of cases postoperatively.

At the press conference, data also were reported from the BRIDGE study. That study, published online in the New England Journal of Medicine (2015 June 22; epub ahead of print ), found that bridging was not an effective strategy in AF patients who discontinue warfarin prior to elective surgery. In the press conference, Dr. Thomas L. Ortel, hematology/oncology division, Duke University Medical Center, Durham, N.C., agreed with Dr. Schulman that this is an area where evidence is needed to guide care.

In the absence of data, “physicians do whatever they think is best,” Dr. Schulman noted at the press conference. Referring to strategies for stopping anticoagulants for surgery in patients with AF, Dr. Schulman said, “some of them stop the blood thinner too early because they are afraid that the patient is going to bleed during surgery and instead the patient can have a stroke. Some stop too late, and the patient can have bleeding.”

The data presented at the meeting provide an evidence base for clinical decisions. Dr. Schulman suggested that these data are meaningful for guiding care.

Dr. Ortel disclosed grant/research support from Eisai and Pfizer. Dr. Schulman had no disclosures.

TORONTO – In atrial fibrillation (AF) patients who must discontinue dabigatran for elective surgery, the risk of both stroke and major bleeding can be reduced to low levels using a formalized strategy for stopping and then restarting anticoagulation, according to results of a prospective study presented at the International Society on Thrombosis and Haemostasis Congress.

Among key findings presented at a press conference at the ISTH 2015 Congress, no strokes were recorded in more than 500 patients managed with the protocol, and the major bleeding rate was less than 2%, reported the study’s principal investigator, Dr. Sam Schulman, professor of hematology and thromboembolism, McMaster University, Hamilton, Ont.

Data from this study (Circulation 2015) were reported at the press conference alongside a second study of perioperative warfarin management. Both studies are potentially practice changing, because they supply evidence-based guidance for anticoagulation in patients with AF.

Courtesy International Society of Thrombosis and Haemostasis

Based on the findings from these two studies, “it is important to get this message out” that there are now data available on which to base clinical decisions, reported Dr. Schulman, who is also president of the ISTH 2015 Congress. His data were presented alongside a study that found no benefit from heparin bridging in AF patients when warfarin was stopped 5 days in advance of surgery.

In the study presented by Dr. Schulman, 542 patients with AF who were on dabigatran and scheduled for elective surgery were managed on a prespecified protocol for risk assessment. The protocol provided a time for stopping dabigatran before surgery based on such factors as renal function and procedure-related bleeding risk. Dabigatran was restarted after surgery on prespecified measures of surgery complexity and severity of consequences if bleeding occurred.

The primary outcome evaluated in the study was major bleeding in the first 30 days. Other outcomes of interest included thromboembolic complications, death and minor bleeding.

Major bleeding was observed in 1.8% of patients, a rate that Dr. Schulman characterized as “low and acceptable” in the context of expected background bleeding rates. There were four deaths, but all were unrelated to either bleeding or arterial thromboembolism. The only thromboembolic complication was a single transient ischemic attack. Minor bleeding occurred in 5.2%.

On the basis of the protocol, about half of the patients discontinued dabigatran 24 hours before surgery. No patient discontinued therapy more than 96 hours prior to surgery. The median time to resumption of dabigatran after surgery was 1 day, but the point at which it was restarted ranged between hours and 2 days. Bridging, which describes the injection of heparin for short-term anticoagulation, was not employed preoperatively but was used in 1.7% of cases postoperatively.

At the press conference, data also were reported from the BRIDGE study. That study, published online in the New England Journal of Medicine (2015 June 22; epub ahead of print ), found that bridging was not an effective strategy in AF patients who discontinue warfarin prior to elective surgery. In the press conference, Dr. Thomas L. Ortel, hematology/oncology division, Duke University Medical Center, Durham, N.C., agreed with Dr. Schulman that this is an area where evidence is needed to guide care.

In the absence of data, “physicians do whatever they think is best,” Dr. Schulman noted at the press conference. Referring to strategies for stopping anticoagulants for surgery in patients with AF, Dr. Schulman said, “some of them stop the blood thinner too early because they are afraid that the patient is going to bleed during surgery and instead the patient can have a stroke. Some stop too late, and the patient can have bleeding.”

The data presented at the meeting provide an evidence base for clinical decisions. Dr. Schulman suggested that these data are meaningful for guiding care.

Dr. Ortel disclosed grant/research support from Eisai and Pfizer. Dr. Schulman had no disclosures.

The first update to U.S. guidelines for managing hypertension in adult patients with coronary artery disease in 8 years reset the target blood pressure for most of these patients to less than 140/90 mm Hg, and highlighted beta-blockers, renin-angiotensin-aldosterone system blockers, and thiazide diuretics as the mainstays of drug treatment for these patients.

The main messages in the new scientific statement from the American Heart Association, American College of Cardiology, and American Society of Hypertension, released on March 31 in an article published online (Hypertension 2015 [doi:10.116/HYP.0000000000000018]) are the blood pressure targets set for patients with coronary artery disease (CAD) and the designations of the preferred drugs to use to achieve the blood pressure goals when lifestyle measures alone prove inadequate, said Dr. Clive Rosendorff, chair of the panel that wrote the new statement.

But the statement also highlighted that a blood pressure target of less than 130/80 mm Hg “could be considered” and was reasonable for selected CAD patients whom physicians judge capable of achieving this lower blood pressure level safely and who are at especially high risk for cerebrovascular events.

“We felt the best evidence [to prevent future cardiovascular events] was to reduce pressure below 140/90 mm Hg, but a goal pressure of less than 130/80 mm Hg may be appropriate in some cases; we left it to the discretion of physicians to decide which blood pressure target to choose,” said Dr. Rosendorff, professor of medicine at Mount Sinai Hospital in New York.

The default blood pressure goal of less than 140/90 for most CAD patients represented an increase from the less than 130/80 mm Hg goal set by the prior edition of this guideline, issued in 2007 (Circulation 2007;115:2761-88). Current evidence for the lower blood pressure target of less than 130/80 mm Hg “was not as strong,” Dr. Rosendorff said in an interview. He suggested that physicians consider using the lower target for patients who are younger, reasonably healthy, able to tolerate a regimen that brings them to a lower blood pressure without an increase in angina or other significant effects caused by the drugs themselves, do not experience compromised renal function with reduced blood pressure, and have an increased risk for cerebrovascular events.

“These guidelines are not rigid, and should involve a discussion with the patient of the benefits and risks,” he said.

The new statement targets a blood pressure goal of less than 150/90 mm Hg for CAD patients who are more than 80 years old.

The new target for CAD patients represents something of a response to the blood pressure target of less than 150/90 mm Hg for people at least 60 years old recommended last year in recommendations made by the panel originally assembled as the Eighth Joint National Committee (JNC 8) (JAMA 2014;311:507-20). Although the JNC 8 recommendations aimed at the general population in a primary prevention setting, as opposed to CAD patients for whom secondary prevention is the goal, the target of less than 150/90 mm Hg became “highly controversial” and was a factor in composing the new recommendation, Dr. Rosendorff said. He also stressed that the AHA, ACC, and ASH have assembled a group that is formulating new recommendations for diagnosing and managing hypertension for the general population in a primary prevention setting that will come out sometime in the future.

The new hypertension guideline for CAD patients and the 2014 statement from the JNC 8 panel should be seen as distinct recommendations because they targeted different patient populations and because they were based on different ground rules for evidence, said Dr. Suzanne Oparil, one of three people who served on both writing groups. The JNC 8 group focused exclusively on findings from randomized, controlled trials that used hard cardiovascular disease endpoints. The writing committee for the new guidelines targeted specifically at CAD patients also considered evidence from epidemiologic studies. In addition, the new guidelines is targeted at primarily a cardiologist audience, while the 2014 JNC 8 guidelines were written primarily for primary care physicians, she said in an interview.

“I do not believe that the new CAD guidelines will change practice. They reflect what most cardiologists already do,” said Dr. Oparil, professor of medicine and director of the vascular biology and hypertension program at the University of Alabama, Birmingham.

Regarding antihypertensive drug selection the new statement endorses a focus on treating hypertensive patients with established CAD with a beta-blocker, a renin-angiotensin-aldosterone system blocker such as an ACE inhibitor or angiotensin-receptor blocker, and a thiazide or thiazide-like diuretic. Hypertensive patients with CAD should immediately start on all three drug classes, Dr. Rosendorff said.

“For patients with established CAD, a treatment with a beta-blocker moves from the limbo they are in for treating uncomplicated hypertension to center stage,” he said. The statement gives more detailed guidance on which specific drugs from the beta-blocker class have the best evidence for efficacy in various types of patients with CAD.

Dr. Rosendorff had no disclosures. Dr. Oparil has been a consultant to Bayer, Daiichi Sankyo, and Pfizer, and has received research grants from Medtronic, Merck, Novartis, and Takeda.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

The first update to U.S. guidelines for managing hypertension in adult patients with coronary artery disease in 8 years reset the target blood pressure for most of these patients to less than 140/90 mm Hg, and highlighted beta-blockers, renin-angiotensin-aldosterone system blockers, and thiazide diuretics as the mainstays of drug treatment for these patients.

The main messages in the new scientific statement from the American Heart Association, American College of Cardiology, and American Society of Hypertension, released on March 31 in an article published online (Hypertension 2015 [doi:10.116/HYP.0000000000000018]) are the blood pressure targets set for patients with coronary artery disease (CAD) and the designations of the preferred drugs to use to achieve the blood pressure goals when lifestyle measures alone prove inadequate, said Dr. Clive Rosendorff, chair of the panel that wrote the new statement.

But the statement also highlighted that a blood pressure target of less than 130/80 mm Hg “could be considered” and was reasonable for selected CAD patients whom physicians judge capable of achieving this lower blood pressure level safely and who are at especially high risk for cerebrovascular events.

“We felt the best evidence [to prevent future cardiovascular events] was to reduce pressure below 140/90 mm Hg, but a goal pressure of less than 130/80 mm Hg may be appropriate in some cases; we left it to the discretion of physicians to decide which blood pressure target to choose,” said Dr. Rosendorff, professor of medicine at Mount Sinai Hospital in New York.

The default blood pressure goal of less than 140/90 for most CAD patients represented an increase from the less than 130/80 mm Hg goal set by the prior edition of this guideline, issued in 2007 (Circulation 2007;115:2761-88). Current evidence for the lower blood pressure target of less than 130/80 mm Hg “was not as strong,” Dr. Rosendorff said in an interview. He suggested that physicians consider using the lower target for patients who are younger, reasonably healthy, able to tolerate a regimen that brings them to a lower blood pressure without an increase in angina or other significant effects caused by the drugs themselves, do not experience compromised renal function with reduced blood pressure, and have an increased risk for cerebrovascular events.

“These guidelines are not rigid, and should involve a discussion with the patient of the benefits and risks,” he said.

The new statement targets a blood pressure goal of less than 150/90 mm Hg for CAD patients who are more than 80 years old.

The new target for CAD patients represents something of a response to the blood pressure target of less than 150/90 mm Hg for people at least 60 years old recommended last year in recommendations made by the panel originally assembled as the Eighth Joint National Committee (JNC 8) (JAMA 2014;311:507-20). Although the JNC 8 recommendations aimed at the general population in a primary prevention setting, as opposed to CAD patients for whom secondary prevention is the goal, the target of less than 150/90 mm Hg became “highly controversial” and was a factor in composing the new recommendation, Dr. Rosendorff said. He also stressed that the AHA, ACC, and ASH have assembled a group that is formulating new recommendations for diagnosing and managing hypertension for the general population in a primary prevention setting that will come out sometime in the future.

The new hypertension guideline for CAD patients and the 2014 statement from the JNC 8 panel should be seen as distinct recommendations because they targeted different patient populations and because they were based on different ground rules for evidence, said Dr. Suzanne Oparil, one of three people who served on both writing groups. The JNC 8 group focused exclusively on findings from randomized, controlled trials that used hard cardiovascular disease endpoints. The writing committee for the new guidelines targeted specifically at CAD patients also considered evidence from epidemiologic studies. In addition, the new guidelines is targeted at primarily a cardiologist audience, while the 2014 JNC 8 guidelines were written primarily for primary care physicians, she said in an interview.

“I do not believe that the new CAD guidelines will change practice. They reflect what most cardiologists already do,” said Dr. Oparil, professor of medicine and director of the vascular biology and hypertension program at the University of Alabama, Birmingham.

Regarding antihypertensive drug selection the new statement endorses a focus on treating hypertensive patients with established CAD with a beta-blocker, a renin-angiotensin-aldosterone system blocker such as an ACE inhibitor or angiotensin-receptor blocker, and a thiazide or thiazide-like diuretic. Hypertensive patients with CAD should immediately start on all three drug classes, Dr. Rosendorff said.

“For patients with established CAD, a treatment with a beta-blocker moves from the limbo they are in for treating uncomplicated hypertension to center stage,” he said. The statement gives more detailed guidance on which specific drugs from the beta-blocker class have the best evidence for efficacy in various types of patients with CAD.

Dr. Rosendorff had no disclosures. Dr. Oparil has been a consultant to Bayer, Daiichi Sankyo, and Pfizer, and has received research grants from Medtronic, Merck, Novartis, and Takeda.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

The first update to U.S. guidelines for managing hypertension in adult patients with coronary artery disease in 8 years reset the target blood pressure for most of these patients to less than 140/90 mm Hg, and highlighted beta-blockers, renin-angiotensin-aldosterone system blockers, and thiazide diuretics as the mainstays of drug treatment for these patients.

The main messages in the new scientific statement from the American Heart Association, American College of Cardiology, and American Society of Hypertension, released on March 31 in an article published online (Hypertension 2015 [doi:10.116/HYP.0000000000000018]) are the blood pressure targets set for patients with coronary artery disease (CAD) and the designations of the preferred drugs to use to achieve the blood pressure goals when lifestyle measures alone prove inadequate, said Dr. Clive Rosendorff, chair of the panel that wrote the new statement.

But the statement also highlighted that a blood pressure target of less than 130/80 mm Hg “could be considered” and was reasonable for selected CAD patients whom physicians judge capable of achieving this lower blood pressure level safely and who are at especially high risk for cerebrovascular events.

“We felt the best evidence [to prevent future cardiovascular events] was to reduce pressure below 140/90 mm Hg, but a goal pressure of less than 130/80 mm Hg may be appropriate in some cases; we left it to the discretion of physicians to decide which blood pressure target to choose,” said Dr. Rosendorff, professor of medicine at Mount Sinai Hospital in New York.

The default blood pressure goal of less than 140/90 for most CAD patients represented an increase from the less than 130/80 mm Hg goal set by the prior edition of this guideline, issued in 2007 (Circulation 2007;115:2761-88). Current evidence for the lower blood pressure target of less than 130/80 mm Hg “was not as strong,” Dr. Rosendorff said in an interview. He suggested that physicians consider using the lower target for patients who are younger, reasonably healthy, able to tolerate a regimen that brings them to a lower blood pressure without an increase in angina or other significant effects caused by the drugs themselves, do not experience compromised renal function with reduced blood pressure, and have an increased risk for cerebrovascular events.

“These guidelines are not rigid, and should involve a discussion with the patient of the benefits and risks,” he said.

The new statement targets a blood pressure goal of less than 150/90 mm Hg for CAD patients who are more than 80 years old.

The new target for CAD patients represents something of a response to the blood pressure target of less than 150/90 mm Hg for people at least 60 years old recommended last year in recommendations made by the panel originally assembled as the Eighth Joint National Committee (JNC 8) (JAMA 2014;311:507-20). Although the JNC 8 recommendations aimed at the general population in a primary prevention setting, as opposed to CAD patients for whom secondary prevention is the goal, the target of less than 150/90 mm Hg became “highly controversial” and was a factor in composing the new recommendation, Dr. Rosendorff said. He also stressed that the AHA, ACC, and ASH have assembled a group that is formulating new recommendations for diagnosing and managing hypertension for the general population in a primary prevention setting that will come out sometime in the future.

The new hypertension guideline for CAD patients and the 2014 statement from the JNC 8 panel should be seen as distinct recommendations because they targeted different patient populations and because they were based on different ground rules for evidence, said Dr. Suzanne Oparil, one of three people who served on both writing groups. The JNC 8 group focused exclusively on findings from randomized, controlled trials that used hard cardiovascular disease endpoints. The writing committee for the new guidelines targeted specifically at CAD patients also considered evidence from epidemiologic studies. In addition, the new guidelines is targeted at primarily a cardiologist audience, while the 2014 JNC 8 guidelines were written primarily for primary care physicians, she said in an interview.

“I do not believe that the new CAD guidelines will change practice. They reflect what most cardiologists already do,” said Dr. Oparil, professor of medicine and director of the vascular biology and hypertension program at the University of Alabama, Birmingham.

Regarding antihypertensive drug selection the new statement endorses a focus on treating hypertensive patients with established CAD with a beta-blocker, a renin-angiotensin-aldosterone system blocker such as an ACE inhibitor or angiotensin-receptor blocker, and a thiazide or thiazide-like diuretic. Hypertensive patients with CAD should immediately start on all three drug classes, Dr. Rosendorff said.

“For patients with established CAD, a treatment with a beta-blocker moves from the limbo they are in for treating uncomplicated hypertension to center stage,” he said. The statement gives more detailed guidance on which specific drugs from the beta-blocker class have the best evidence for efficacy in various types of patients with CAD.

Dr. Rosendorff had no disclosures. Dr. Oparil has been a consultant to Bayer, Daiichi Sankyo, and Pfizer, and has received research grants from Medtronic, Merck, Novartis, and Takeda.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

Clinicians should not screen for cardiac disease in asymptomatic, low-risk adults using resting or stress electrocardiography, stress echocardiography, or stress myocardial perfusion imaging , according to new guidelines from the American College of Physicians.

“There is no evidence that cardiac screening of low-risk adults with resting or stress ECG, stress echocardiography, or stress MPI improves outcomes, but it is associated with increased costs and potential harms,” wrote the guideline’s author, Dr. Roger Chou, associate professor of medicine at Oregon Health & Science University, Portland.

hepatus/iStockphoto.com

The recommendation is based on a systematic literature review, recommendations from the U.S. Preventive Services Task Force, and American College of Cardiology guidelines. The new ACP clinical guideline was published March 17 in Annals of Internal Medicine (doi: 10.7326/M14-1225).

“What we are saying here is that, as physicians, we have responsibility to understand what the pretest probability is, and what the likelihood is that someone actually has disease – and if it’s low enough, then doing the screening test is going to cause a lot more false positives than true positives,” Dr. Robert Centor, regional dean of the Huntsville Medical Campus of the University of Alabama at Birmingham, explained in an interview.

“Even if it is a true positive, there is no evidence that we can find that finding that heart disease will do anything other than lead someone to do a procedure that we have no evidence will improve their outcomes,” added Dr. Centor, chair of the ACP Board of Regents.

Despite existing recommendations to the contrary, physicians are increasingly performing these tests on low-risk patients, the ACP cautioned.

For example, a Consumer Reports survey found that “39% of asymptomatic adults without high blood pressure or a high cholesterol level reported having ECG within the past 5 years, and 12% reported undergoing exercise ECG,” Dr. Chou wrote in his report on behalf of the ACP High Value Care Task Force. More than half of those patients said their physicians recommended the tests as part of their routine health care.

The rise in the use of such tests is likely the result of a combination of factors, Dr. Centor said. Those factors include money (patients see no out-of-pocket cost and thus don’t consider the cost of tests in their decision making), direct-to-consumer advertising, fear on behalf of physicians that they might miss a diagnosis, and a lack of understanding by patients on the adverse effects of screening if they are at low risk for heart disease.

Dr. Chou identified a number of potential harms related to unnecessary screenings, including sudden death or hospitalization during stress tests; adverse events from pharmacologics used to induce stress; radiation exposure from myocardial perfusion imaging; false positive results that, in turn, lead to anxiety by the patient and additional unnecessary tests and treatments; disease labeling; and downstream harms from follow-up testing and interventions.

“To be most effective, efforts to reduce the use of imaging should be multifocal and should address clinician behavior, patient expectations, direct-to-consumer screening programs, and financial incentives,” Dr. Chou explained.

In low-risk patients, physicians instead should “focus on treating modifiable risk factors (such as smoking, diabetes, hypertension, hyperlipidemia, and overweight) and encouraging healthy levels of exercise,” according to the guideline.

gtwachtman@frontlinemedcom.com

Clinicians should not screen for cardiac disease in asymptomatic, low-risk adults using resting or stress electrocardiography, stress echocardiography, or stress myocardial perfusion imaging , according to new guidelines from the American College of Physicians.

“There is no evidence that cardiac screening of low-risk adults with resting or stress ECG, stress echocardiography, or stress MPI improves outcomes, but it is associated with increased costs and potential harms,” wrote the guideline’s author, Dr. Roger Chou, associate professor of medicine at Oregon Health & Science University, Portland.

hepatus/iStockphoto.com

The recommendation is based on a systematic literature review, recommendations from the U.S. Preventive Services Task Force, and American College of Cardiology guidelines. The new ACP clinical guideline was published March 17 in Annals of Internal Medicine (doi: 10.7326/M14-1225).

“What we are saying here is that, as physicians, we have responsibility to understand what the pretest probability is, and what the likelihood is that someone actually has disease – and if it’s low enough, then doing the screening test is going to cause a lot more false positives than true positives,” Dr. Robert Centor, regional dean of the Huntsville Medical Campus of the University of Alabama at Birmingham, explained in an interview.

“Even if it is a true positive, there is no evidence that we can find that finding that heart disease will do anything other than lead someone to do a procedure that we have no evidence will improve their outcomes,” added Dr. Centor, chair of the ACP Board of Regents.

Despite existing recommendations to the contrary, physicians are increasingly performing these tests on low-risk patients, the ACP cautioned.

For example, a Consumer Reports survey found that “39% of asymptomatic adults without high blood pressure or a high cholesterol level reported having ECG within the past 5 years, and 12% reported undergoing exercise ECG,” Dr. Chou wrote in his report on behalf of the ACP High Value Care Task Force. More than half of those patients said their physicians recommended the tests as part of their routine health care.

The rise in the use of such tests is likely the result of a combination of factors, Dr. Centor said. Those factors include money (patients see no out-of-pocket cost and thus don’t consider the cost of tests in their decision making), direct-to-consumer advertising, fear on behalf of physicians that they might miss a diagnosis, and a lack of understanding by patients on the adverse effects of screening if they are at low risk for heart disease.

Dr. Chou identified a number of potential harms related to unnecessary screenings, including sudden death or hospitalization during stress tests; adverse events from pharmacologics used to induce stress; radiation exposure from myocardial perfusion imaging; false positive results that, in turn, lead to anxiety by the patient and additional unnecessary tests and treatments; disease labeling; and downstream harms from follow-up testing and interventions.

“To be most effective, efforts to reduce the use of imaging should be multifocal and should address clinician behavior, patient expectations, direct-to-consumer screening programs, and financial incentives,” Dr. Chou explained.

In low-risk patients, physicians instead should “focus on treating modifiable risk factors (such as smoking, diabetes, hypertension, hyperlipidemia, and overweight) and encouraging healthy levels of exercise,” according to the guideline.

gtwachtman@frontlinemedcom.com

Clinicians should not screen for cardiac disease in asymptomatic, low-risk adults using resting or stress electrocardiography, stress echocardiography, or stress myocardial perfusion imaging , according to new guidelines from the American College of Physicians.

“There is no evidence that cardiac screening of low-risk adults with resting or stress ECG, stress echocardiography, or stress MPI improves outcomes, but it is associated with increased costs and potential harms,” wrote the guideline’s author, Dr. Roger Chou, associate professor of medicine at Oregon Health & Science University, Portland.

hepatus/iStockphoto.com

The recommendation is based on a systematic literature review, recommendations from the U.S. Preventive Services Task Force, and American College of Cardiology guidelines. The new ACP clinical guideline was published March 17 in Annals of Internal Medicine (doi: 10.7326/M14-1225).

“What we are saying here is that, as physicians, we have responsibility to understand what the pretest probability is, and what the likelihood is that someone actually has disease – and if it’s low enough, then doing the screening test is going to cause a lot more false positives than true positives,” Dr. Robert Centor, regional dean of the Huntsville Medical Campus of the University of Alabama at Birmingham, explained in an interview.

“Even if it is a true positive, there is no evidence that we can find that finding that heart disease will do anything other than lead someone to do a procedure that we have no evidence will improve their outcomes,” added Dr. Centor, chair of the ACP Board of Regents.

Despite existing recommendations to the contrary, physicians are increasingly performing these tests on low-risk patients, the ACP cautioned.

For example, a Consumer Reports survey found that “39% of asymptomatic adults without high blood pressure or a high cholesterol level reported having ECG within the past 5 years, and 12% reported undergoing exercise ECG,” Dr. Chou wrote in his report on behalf of the ACP High Value Care Task Force. More than half of those patients said their physicians recommended the tests as part of their routine health care.

The rise in the use of such tests is likely the result of a combination of factors, Dr. Centor said. Those factors include money (patients see no out-of-pocket cost and thus don’t consider the cost of tests in their decision making), direct-to-consumer advertising, fear on behalf of physicians that they might miss a diagnosis, and a lack of understanding by patients on the adverse effects of screening if they are at low risk for heart disease.

Dr. Chou identified a number of potential harms related to unnecessary screenings, including sudden death or hospitalization during stress tests; adverse events from pharmacologics used to induce stress; radiation exposure from myocardial perfusion imaging; false positive results that, in turn, lead to anxiety by the patient and additional unnecessary tests and treatments; disease labeling; and downstream harms from follow-up testing and interventions.

“To be most effective, efforts to reduce the use of imaging should be multifocal and should address clinician behavior, patient expectations, direct-to-consumer screening programs, and financial incentives,” Dr. Chou explained.

In low-risk patients, physicians instead should “focus on treating modifiable risk factors (such as smoking, diabetes, hypertension, hyperlipidemia, and overweight) and encouraging healthy levels of exercise,” according to the guideline.

gtwachtman@frontlinemedcom.com

Recommendations to manufacturers about improving the safety of reusable medical devices and an upcoming advisory committee meeting on duodenoscope-associated infections are two efforts recently announced by the Food and Drug Administration that address the risks associated with reusable devices.

A final guidance document for industry on reprocessing reusable medical devices includes recommendations “aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection,” according to the March 12 announcement. Also included in the guidance are criteria that should be met in instructions for reprocessing reusable devices, “to ensure users understand and correctly follow the reprocessing instructions,” and recommendations that manufacturers should consider “reprocessing challenges” at the early stages of the design of such devices.

The same announcement said that in mid-May, the FDA was convening a 2-day meeting of the agency’s Gastroenterology and Urology Devices Panel to discuss the recent reports of infections associated with the use of duodenoscopes in endoscopic retrograde cholangiopancreatography (ERCP) procedures in U.S. hospitals.

The announcement was issued less than a month after the agency alerted health care professionals and the public about the association with duodenoscopes and the transmission of multidrug-resistant bacterial infections in patients who had undergone ERCP procedures, despite proper cleaning and disinfection of the devices. Between January 2013 and December 2014, the agency received 75 medical device adverse event reports for about 135 patients in the United States “relating to possible microbial transmission from reprocessed duodenoscopes,” according to the safety communication issued by the FDA on Feb. 19.

©CDC/ Melissa Brower

These reports and cases described in the medical literature have occurred even when manufacturer instructions for cleaning and sterilization were followed.

“Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection,” according to the statement, which pointed out that it can be difficult to access some parts of the duodenoscopes when they are cleaned. Problems include the “elevator” mechanism at the tip of the duodenoscope, which should be manually brushed, but a brush may not be able to reach microscopic crevices in this mechanism and “residual body fluids and organic debris may remain in these crevices after cleaning and disinfection,” possibly exposing patients to serious infections if the fluids are contaminated with microbes.

The infections reported include carbapenem-resistant Enterobacteriaceae (CRE), according to the first FDA statement, which did not mention whether any of the reports were fatal.

But on Feb. 18, the UCLA Health System announced that CRE may have been transmitted to seven patients during ERCP procedures, and may have contributed to the death of two of the patients. The two devices implicated in these cases are no longer used and the medical center has started to use a decontamination process “that goes above and beyond manufacturer and national standards” for the devices, the statement said. More than 100 patients who had an ERCP between October 2014 and January 2015 at UCLA have been notified they may have been infected with CRE.

The FDA statement includes recommendations for facilities and staff that reprocess duodenoscopes, for patients, and for health care professionals. One recommendation is to take a duodenoscope out of service if there is any suspicion it may be linked to a multidrug-resistant infection in a patient who has undergone ERCP.

In early March, another outbreak was reported at Cedars-Sinai Medical Center in Los Angeles, which announced that four patients who had undergone an ERCP procedure between August 2014 and January 2015 with the same duodenoscope had been infected with CRE, “despite the fact that Cedars-Sinai meticulously followed the disinfection procedure for duodenoscopes recommended in instructions provided by the manufacturer (Olympus Corporation) and the FDA.” This duodenoscope was the TJF-Q180 V model, a Cedars-Sinai spokesperson confirmed.

This particular duodenoscope has not yet been cleared for marketing, but has been used commercially, according to an FDA statement March 4 updating the duodenoscope-associated infection issue. The statement said that there was “no evidence” that the lack of clearance was associated with infections, and that the reported infections were associated with duodenoscopes from all three manufacturers of the devices used in the United States. In addition, the FDA statement noted that if the TJF-Q180 V duodenoscope was removed from the market, there may not be enough duodenoscopes to meet “the clinical demand in the United States of approximately 500,000 procedures per year.”

At the advisory panel meeting May 14-15, the FDA will ask the expert panel to discuss and make recommendations on various issues, including approaches that ensure patient safety during ERCP procedures and the effectiveness of the cleaning, disinfection, and sterilization procedures for duodenoscopes.

The FDA is asking health care professionals to report any infections possibly related to ERCP duodenoscopes to the manufacturers and the FDA’s MedWatch program.

The Centers for Disease Control and Prevention has provided an interim protocol for health care facilities, with information on monitoring for bacterial contamination of duodenoscopes after reprocessing and other reprocessing issues.

emechcatie@frontlinemedcom.com

Recommendations to manufacturers about improving the safety of reusable medical devices and an upcoming advisory committee meeting on duodenoscope-associated infections are two efforts recently announced by the Food and Drug Administration that address the risks associated with reusable devices.

A final guidance document for industry on reprocessing reusable medical devices includes recommendations “aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection,” according to the March 12 announcement. Also included in the guidance are criteria that should be met in instructions for reprocessing reusable devices, “to ensure users understand and correctly follow the reprocessing instructions,” and recommendations that manufacturers should consider “reprocessing challenges” at the early stages of the design of such devices.

The same announcement said that in mid-May, the FDA was convening a 2-day meeting of the agency’s Gastroenterology and Urology Devices Panel to discuss the recent reports of infections associated with the use of duodenoscopes in endoscopic retrograde cholangiopancreatography (ERCP) procedures in U.S. hospitals.

The announcement was issued less than a month after the agency alerted health care professionals and the public about the association with duodenoscopes and the transmission of multidrug-resistant bacterial infections in patients who had undergone ERCP procedures, despite proper cleaning and disinfection of the devices. Between January 2013 and December 2014, the agency received 75 medical device adverse event reports for about 135 patients in the United States “relating to possible microbial transmission from reprocessed duodenoscopes,” according to the safety communication issued by the FDA on Feb. 19.

©CDC/ Melissa Brower

These reports and cases described in the medical literature have occurred even when manufacturer instructions for cleaning and sterilization were followed.

“Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection,” according to the statement, which pointed out that it can be difficult to access some parts of the duodenoscopes when they are cleaned. Problems include the “elevator” mechanism at the tip of the duodenoscope, which should be manually brushed, but a brush may not be able to reach microscopic crevices in this mechanism and “residual body fluids and organic debris may remain in these crevices after cleaning and disinfection,” possibly exposing patients to serious infections if the fluids are contaminated with microbes.

The infections reported include carbapenem-resistant Enterobacteriaceae (CRE), according to the first FDA statement, which did not mention whether any of the reports were fatal.

But on Feb. 18, the UCLA Health System announced that CRE may have been transmitted to seven patients during ERCP procedures, and may have contributed to the death of two of the patients. The two devices implicated in these cases are no longer used and the medical center has started to use a decontamination process “that goes above and beyond manufacturer and national standards” for the devices, the statement said. More than 100 patients who had an ERCP between October 2014 and January 2015 at UCLA have been notified they may have been infected with CRE.

The FDA statement includes recommendations for facilities and staff that reprocess duodenoscopes, for patients, and for health care professionals. One recommendation is to take a duodenoscope out of service if there is any suspicion it may be linked to a multidrug-resistant infection in a patient who has undergone ERCP.

In early March, another outbreak was reported at Cedars-Sinai Medical Center in Los Angeles, which announced that four patients who had undergone an ERCP procedure between August 2014 and January 2015 with the same duodenoscope had been infected with CRE, “despite the fact that Cedars-Sinai meticulously followed the disinfection procedure for duodenoscopes recommended in instructions provided by the manufacturer (Olympus Corporation) and the FDA.” This duodenoscope was the TJF-Q180 V model, a Cedars-Sinai spokesperson confirmed.

This particular duodenoscope has not yet been cleared for marketing, but has been used commercially, according to an FDA statement March 4 updating the duodenoscope-associated infection issue. The statement said that there was “no evidence” that the lack of clearance was associated with infections, and that the reported infections were associated with duodenoscopes from all three manufacturers of the devices used in the United States. In addition, the FDA statement noted that if the TJF-Q180 V duodenoscope was removed from the market, there may not be enough duodenoscopes to meet “the clinical demand in the United States of approximately 500,000 procedures per year.”

At the advisory panel meeting May 14-15, the FDA will ask the expert panel to discuss and make recommendations on various issues, including approaches that ensure patient safety during ERCP procedures and the effectiveness of the cleaning, disinfection, and sterilization procedures for duodenoscopes.

The FDA is asking health care professionals to report any infections possibly related to ERCP duodenoscopes to the manufacturers and the FDA’s MedWatch program.

The Centers for Disease Control and Prevention has provided an interim protocol for health care facilities, with information on monitoring for bacterial contamination of duodenoscopes after reprocessing and other reprocessing issues.

emechcatie@frontlinemedcom.com

Recommendations to manufacturers about improving the safety of reusable medical devices and an upcoming advisory committee meeting on duodenoscope-associated infections are two efforts recently announced by the Food and Drug Administration that address the risks associated with reusable devices.

A final guidance document for industry on reprocessing reusable medical devices includes recommendations “aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection,” according to the March 12 announcement. Also included in the guidance are criteria that should be met in instructions for reprocessing reusable devices, “to ensure users understand and correctly follow the reprocessing instructions,” and recommendations that manufacturers should consider “reprocessing challenges” at the early stages of the design of such devices.

The same announcement said that in mid-May, the FDA was convening a 2-day meeting of the agency’s Gastroenterology and Urology Devices Panel to discuss the recent reports of infections associated with the use of duodenoscopes in endoscopic retrograde cholangiopancreatography (ERCP) procedures in U.S. hospitals.

The announcement was issued less than a month after the agency alerted health care professionals and the public about the association with duodenoscopes and the transmission of multidrug-resistant bacterial infections in patients who had undergone ERCP procedures, despite proper cleaning and disinfection of the devices. Between January 2013 and December 2014, the agency received 75 medical device adverse event reports for about 135 patients in the United States “relating to possible microbial transmission from reprocessed duodenoscopes,” according to the safety communication issued by the FDA on Feb. 19.

©CDC/ Melissa Brower

These reports and cases described in the medical literature have occurred even when manufacturer instructions for cleaning and sterilization were followed.

“Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection,” according to the statement, which pointed out that it can be difficult to access some parts of the duodenoscopes when they are cleaned. Problems include the “elevator” mechanism at the tip of the duodenoscope, which should be manually brushed, but a brush may not be able to reach microscopic crevices in this mechanism and “residual body fluids and organic debris may remain in these crevices after cleaning and disinfection,” possibly exposing patients to serious infections if the fluids are contaminated with microbes.

The infections reported include carbapenem-resistant Enterobacteriaceae (CRE), according to the first FDA statement, which did not mention whether any of the reports were fatal.

But on Feb. 18, the UCLA Health System announced that CRE may have been transmitted to seven patients during ERCP procedures, and may have contributed to the death of two of the patients. The two devices implicated in these cases are no longer used and the medical center has started to use a decontamination process “that goes above and beyond manufacturer and national standards” for the devices, the statement said. More than 100 patients who had an ERCP between October 2014 and January 2015 at UCLA have been notified they may have been infected with CRE.

The FDA statement includes recommendations for facilities and staff that reprocess duodenoscopes, for patients, and for health care professionals. One recommendation is to take a duodenoscope out of service if there is any suspicion it may be linked to a multidrug-resistant infection in a patient who has undergone ERCP.

In early March, another outbreak was reported at Cedars-Sinai Medical Center in Los Angeles, which announced that four patients who had undergone an ERCP procedure between August 2014 and January 2015 with the same duodenoscope had been infected with CRE, “despite the fact that Cedars-Sinai meticulously followed the disinfection procedure for duodenoscopes recommended in instructions provided by the manufacturer (Olympus Corporation) and the FDA.” This duodenoscope was the TJF-Q180 V model, a Cedars-Sinai spokesperson confirmed.

This particular duodenoscope has not yet been cleared for marketing, but has been used commercially, according to an FDA statement March 4 updating the duodenoscope-associated infection issue. The statement said that there was “no evidence” that the lack of clearance was associated with infections, and that the reported infections were associated with duodenoscopes from all three manufacturers of the devices used in the United States. In addition, the FDA statement noted that if the TJF-Q180 V duodenoscope was removed from the market, there may not be enough duodenoscopes to meet “the clinical demand in the United States of approximately 500,000 procedures per year.”

At the advisory panel meeting May 14-15, the FDA will ask the expert panel to discuss and make recommendations on various issues, including approaches that ensure patient safety during ERCP procedures and the effectiveness of the cleaning, disinfection, and sterilization procedures for duodenoscopes.

The FDA is asking health care professionals to report any infections possibly related to ERCP duodenoscopes to the manufacturers and the FDA’s MedWatch program.

The Centers for Disease Control and Prevention has provided an interim protocol for health care facilities, with information on monitoring for bacterial contamination of duodenoscopes after reprocessing and other reprocessing issues.

emechcatie@frontlinemedcom.com

The National Comprehensive Cancer Network has published a new guideline on smoking cessation for cancer patients that recommends combining pharmacologic therapy with counseling as the most effective approach, along with rigorous review and close follow-ups to prevent relapses.

“Although the medical community recognizes the importance of smoking cessation, supporting patients in ceasing to smoke is generally not done well. Our hope is that by addressing smoking cessation in a cancer patient population, we can make it easier for oncologists to effectively support their patients in achieving their smoking cessation goals,” Dr. Peter Shields, deputy director of the Ohio State University Comprehensive Cancer Center, said in a written statement. Of the estimated 590,000 cancer deaths in 2015, about 170,000, or nearly 30%, will be caused by tobacco smoking. Quitting tobacco improves cancer treatment effectiveness and reduces cancer recurrence, according to the NCCN.

Read the full statement on the NCCN website.

The National Comprehensive Cancer Network has published a new guideline on smoking cessation for cancer patients that recommends combining pharmacologic therapy with counseling as the most effective approach, along with rigorous review and close follow-ups to prevent relapses.

“Although the medical community recognizes the importance of smoking cessation, supporting patients in ceasing to smoke is generally not done well. Our hope is that by addressing smoking cessation in a cancer patient population, we can make it easier for oncologists to effectively support their patients in achieving their smoking cessation goals,” Dr. Peter Shields, deputy director of the Ohio State University Comprehensive Cancer Center, said in a written statement. Of the estimated 590,000 cancer deaths in 2015, about 170,000, or nearly 30%, will be caused by tobacco smoking. Quitting tobacco improves cancer treatment effectiveness and reduces cancer recurrence, according to the NCCN.

Read the full statement on the NCCN website.

The National Comprehensive Cancer Network has published a new guideline on smoking cessation for cancer patients that recommends combining pharmacologic therapy with counseling as the most effective approach, along with rigorous review and close follow-ups to prevent relapses.

“Although the medical community recognizes the importance of smoking cessation, supporting patients in ceasing to smoke is generally not done well. Our hope is that by addressing smoking cessation in a cancer patient population, we can make it easier for oncologists to effectively support their patients in achieving their smoking cessation goals,” Dr. Peter Shields, deputy director of the Ohio State University Comprehensive Cancer Center, said in a written statement. Of the estimated 590,000 cancer deaths in 2015, about 170,000, or nearly 30%, will be caused by tobacco smoking. Quitting tobacco improves cancer treatment effectiveness and reduces cancer recurrence, according to the NCCN.

Read the full statement on the NCCN website.

BALTIMORE – If all Americans eligible for statins under new American College of Cardiology/American Heart Association guidelines actually took them, thousands of deaths per year from cardiovascular disease might be prevented but at a cost of increased incidence of diabetes and myopathy.

The 2013 ACC/AHA guidelines expand criteria for the use of statins for primary prevention of CVD to more Americans (Circulation 2015;131:A05). Compliance with those guidelines would save 7,930 lives per year that would have been lost to CVD, according to Quanhe Yang, Ph.D., of the Centers for Disease Control and Prevention’s Division for Heart Disease and Stroke Prevention, and colleagues from the CDC and Emory University, Atlanta. Dr. Yang presented the findings at the American Heart Association Epidemiology and Prevention, Lifestyle and Cardiometabolic Health 2015 Scientific Sessions.

Statins are now indicated for primary prevention of CVD for anyone with an LDL cholesterol level greater than or equal to 190 mg/dL, for individuals aged 40-75 years with diabetes, and for those aged 40-75 years with LDL cholesterol greater than or equal to 70 mg/dL but less than 190 mg/dL who have at least a 7.5% estimated 10-year risk of developing atherosclerotic CVD. This means that an additional 24.2 million Americans are now eligible for statins but are not taking one, according to Dr. Yang and coinvestigators. However, “no study has assessed the potential impact of statin therapy under the new guidelines,” said Dr. Yang.

In order to obtain treatment group-specific atherosclerotic CVD, investigators first estimated hazard ratios for each treatment group by sex from the National Health and Nutrition Examination Survey III (NHANES III)–linked Mortality files. These hazard ratios were then applied to data from NHANES 2005-2010, the 2010 Multiple Cause of Death file, and the 2010 U.S. census to obtain age/race/sex-specific atherosclerotic CVD for each treatment group.

Applying the per-group hazard ratios, Dr. Yang and colleagues calculated that an annual 7,930 atherosclerotic CVD deaths would be prevented with full statin compliance, a reduction of 12.6%. However, modeling predicted an additional 16,400 additional cases of diabetes caused by statin use, he cautioned. More cases of myopathy would also occur, though the estimated number depends on whether the rate is derived from randomized, controlled trials (RCTs) or from population-based reports of myopathy. If the RCT data are used, just 1,510 excess cases of myopathy would be seen, in contrast to the 36,100 cases predicted by population-based data.

The study could model deaths caused by CVD only and not the reduction in disease burden of CVD that would result if all of the additional 24.2 million Americans took a statin, Dr Yang noted. Other limitations of the study included the lack of agreement in incidence of myopathy between RCTs and population-based studies, as well as the likelihood that the risk of diabetes increases with age and higher statin dose – effects not accounted for in the study.

Questioning after the talk focused on sex-specific differences in statin takers. For example, statin-associated diabetes is more common in women than men, another effect not accounted for in the study’s modeling, noted an audience member. Additionally, given that women have been underrepresented in clinical trials in general and in those for CVD in particular, some modeling assumptions in the present study may also lack full generalizability to women at risk for CVD.

BALTIMORE – If all Americans eligible for statins under new American College of Cardiology/American Heart Association guidelines actually took them, thousands of deaths per year from cardiovascular disease might be prevented but at a cost of increased incidence of diabetes and myopathy.

The 2013 ACC/AHA guidelines expand criteria for the use of statins for primary prevention of CVD to more Americans (Circulation 2015;131:A05). Compliance with those guidelines would save 7,930 lives per year that would have been lost to CVD, according to Quanhe Yang, Ph.D., of the Centers for Disease Control and Prevention’s Division for Heart Disease and Stroke Prevention, and colleagues from the CDC and Emory University, Atlanta. Dr. Yang presented the findings at the American Heart Association Epidemiology and Prevention, Lifestyle and Cardiometabolic Health 2015 Scientific Sessions.

Statins are now indicated for primary prevention of CVD for anyone with an LDL cholesterol level greater than or equal to 190 mg/dL, for individuals aged 40-75 years with diabetes, and for those aged 40-75 years with LDL cholesterol greater than or equal to 70 mg/dL but less than 190 mg/dL who have at least a 7.5% estimated 10-year risk of developing atherosclerotic CVD. This means that an additional 24.2 million Americans are now eligible for statins but are not taking one, according to Dr. Yang and coinvestigators. However, “no study has assessed the potential impact of statin therapy under the new guidelines,” said Dr. Yang.

In order to obtain treatment group-specific atherosclerotic CVD, investigators first estimated hazard ratios for each treatment group by sex from the National Health and Nutrition Examination Survey III (NHANES III)–linked Mortality files. These hazard ratios were then applied to data from NHANES 2005-2010, the 2010 Multiple Cause of Death file, and the 2010 U.S. census to obtain age/race/sex-specific atherosclerotic CVD for each treatment group.

Applying the per-group hazard ratios, Dr. Yang and colleagues calculated that an annual 7,930 atherosclerotic CVD deaths would be prevented with full statin compliance, a reduction of 12.6%. However, modeling predicted an additional 16,400 additional cases of diabetes caused by statin use, he cautioned. More cases of myopathy would also occur, though the estimated number depends on whether the rate is derived from randomized, controlled trials (RCTs) or from population-based reports of myopathy. If the RCT data are used, just 1,510 excess cases of myopathy would be seen, in contrast to the 36,100 cases predicted by population-based data.

The study could model deaths caused by CVD only and not the reduction in disease burden of CVD that would result if all of the additional 24.2 million Americans took a statin, Dr Yang noted. Other limitations of the study included the lack of agreement in incidence of myopathy between RCTs and population-based studies, as well as the likelihood that the risk of diabetes increases with age and higher statin dose – effects not accounted for in the study.

Questioning after the talk focused on sex-specific differences in statin takers. For example, statin-associated diabetes is more common in women than men, another effect not accounted for in the study’s modeling, noted an audience member. Additionally, given that women have been underrepresented in clinical trials in general and in those for CVD in particular, some modeling assumptions in the present study may also lack full generalizability to women at risk for CVD.

BALTIMORE – If all Americans eligible for statins under new American College of Cardiology/American Heart Association guidelines actually took them, thousands of deaths per year from cardiovascular disease might be prevented but at a cost of increased incidence of diabetes and myopathy.

The 2013 ACC/AHA guidelines expand criteria for the use of statins for primary prevention of CVD to more Americans (Circulation 2015;131:A05). Compliance with those guidelines would save 7,930 lives per year that would have been lost to CVD, according to Quanhe Yang, Ph.D., of the Centers for Disease Control and Prevention’s Division for Heart Disease and Stroke Prevention, and colleagues from the CDC and Emory University, Atlanta. Dr. Yang presented the findings at the American Heart Association Epidemiology and Prevention, Lifestyle and Cardiometabolic Health 2015 Scientific Sessions.

Statins are now indicated for primary prevention of CVD for anyone with an LDL cholesterol level greater than or equal to 190 mg/dL, for individuals aged 40-75 years with diabetes, and for those aged 40-75 years with LDL cholesterol greater than or equal to 70 mg/dL but less than 190 mg/dL who have at least a 7.5% estimated 10-year risk of developing atherosclerotic CVD. This means that an additional 24.2 million Americans are now eligible for statins but are not taking one, according to Dr. Yang and coinvestigators. However, “no study has assessed the potential impact of statin therapy under the new guidelines,” said Dr. Yang.

In order to obtain treatment group-specific atherosclerotic CVD, investigators first estimated hazard ratios for each treatment group by sex from the National Health and Nutrition Examination Survey III (NHANES III)–linked Mortality files. These hazard ratios were then applied to data from NHANES 2005-2010, the 2010 Multiple Cause of Death file, and the 2010 U.S. census to obtain age/race/sex-specific atherosclerotic CVD for each treatment group.

Applying the per-group hazard ratios, Dr. Yang and colleagues calculated that an annual 7,930 atherosclerotic CVD deaths would be prevented with full statin compliance, a reduction of 12.6%. However, modeling predicted an additional 16,400 additional cases of diabetes caused by statin use, he cautioned. More cases of myopathy would also occur, though the estimated number depends on whether the rate is derived from randomized, controlled trials (RCTs) or from population-based reports of myopathy. If the RCT data are used, just 1,510 excess cases of myopathy would be seen, in contrast to the 36,100 cases predicted by population-based data.

The study could model deaths caused by CVD only and not the reduction in disease burden of CVD that would result if all of the additional 24.2 million Americans took a statin, Dr Yang noted. Other limitations of the study included the lack of agreement in incidence of myopathy between RCTs and population-based studies, as well as the likelihood that the risk of diabetes increases with age and higher statin dose – effects not accounted for in the study.

Questioning after the talk focused on sex-specific differences in statin takers. For example, statin-associated diabetes is more common in women than men, another effect not accounted for in the study’s modeling, noted an audience member. Additionally, given that women have been underrepresented in clinical trials in general and in those for CVD in particular, some modeling assumptions in the present study may also lack full generalizability to women at risk for CVD.

SNOWMASS, COLO. – The 2014 American Heart Association/American College of Cardiology guidelines for the management of valvular heart disease break new ground in numerous ways, Dr. Rick A. Nishimura said at the Annual Cardiovascular Conference at Snowmass.

“We needed to do things differently. These guidelines were created in a different format from prior valvular heart disease guidelines. We wanted these guidelines to promote access to concise, relevant bytes of information at the point of care,” explained Dr. Nishimura, professor of medicine at the Mayo Clinic in Rochester, Minn., and cochair of the guidelines writing committee.

These guidelines – the first major revision in 8 years – introduce a new taxonomy and the first staging system for valvular heart disease. The guidelines also lower the threshold for intervention in asymptomatic patients, recommending surgical or catheter-based treatment at an earlier point in the disease process than ever before. And the guidelines introduce the concept of heart valve centers of excellence, offering a strong recommendation that patients be referred to those centers for procedures to be performed in the asymptomatic phase of disease (J. Am. Coll. Cardiol. 2014;63:2438-88).

These valvular heart disease guidelines place greater emphasis than before on the quality of the scientific evidence underlying recommendations. Since valvular heart disease is a field with a paucity of randomized trials, that meant cutting back.

“Our goal was, if there’s little evidence, don’t write a recommendation. So the number of recommendations went down, but at least the ones that were made were based on evidence,” the cardiologist noted.

Indeed, in the 2006 guidelines, more than 70% of the recommendations were Level of Evidence C and based solely upon expert opinion; in the new guidelines, that’s true for less than 50%. And the proportion of recommendations that are Level of Evidence B increased from 30% to 45%.

The 2014 update was prompted by huge changes in the field of valvular heart disease since 2006. For example, better data became available on the natural history of valvular heart disease. The old concept was not to operate on the asymptomatic patient with severe aortic stenosis and normal left ventricular function, but more recent natural history studies have shown that, left untreated, 72% of such patients will die or develop symptoms within 5 years.

So there has been a push to intervene earlier. Fortunately, that became doable, as recent years also brought improved noninvasive imaging, new catheter-based interventions, and refined surgical methods, enabling operators to safely lower the threshold for intervention in asymptomatic patients while at the same time extending procedural therapies to older, sicker populations.

Dr. Nishimura predicted that cardiologists and surgeons will find the new staging system clinically useful. The four stages, A-D, define the categories “at risk,” “progressive,” “asymptomatic severe,” and “symptomatic severe,” respectively. These categories are particularly helpful in determining how often to schedule patient follow-up and when to time intervention.

The guidelines recommend observation for patients who are Stage A or B and intervention when reasonable in patients who are Stage C2 or D. What bumps a patient with hemodynamically severe yet asymptomatic mitral regurgitation from Stage C1 to C2 is an left ventricular ejection fraction below 60% or a left ventricular end systolic dimension of 40 mm or more. In the setting of asymptomatic aortic stenosis, it’s a peak aortic valve velocity of 4.0 m/sec on Doppler echocardiography plus an LVEF of less than 50%.

The latest guidelines introduced the concept of heart valve centers of excellence in response to evidence of large variability across the country in terms of experience with valve operations. For example, the majority of centers perform fewer than 40 mitral valve repairs per year, and surgeons who perform mitral operations do a median of just five per year. The guideline committee, which included general and interventional cardiologists, surgeons, anesthesiologists, and imaging experts, was persuaded that those numbers are not sufficient to achieve optimal results in complex valve operations for asymptomatic patients.

The criteria for qualifying as a heart valve center of excellence, as defined in the guidelines, include having a multidisciplinary heart valve team, high patient volume, high-level surgical experience and expertise in complex valve procedures, and active participation in multicenter data registries and continuous quality improvement processes.

“The most important thing is you have to be very transparent with your data,” according to the cardiologist.

Ultimately, the most far-reaching change introduced in the current valvular heart disease guidelines is the switch from textbook format to what Dr. Nishimura calls structured data knowledge management.

“The AHA/ACC clinical practice guidelines are generally recognized as the flagship of U.S. cardiovascular medicine, but they’re like a library of old books. Clinically valuable knowledge is buried within documents that can be 200 pages long. What we need at the point of care is the gist: concise, relevant bytes of information that answer a specific clinical question, synthesized by experts,” Dr. Nishimura said.

The new approach is designed to counter the information overload that plagues contemporary medical practice. Each recommendation in the current valvular heart disease guidelines addresses a specific clinical question via a brief summary statement followed by a short explanatory paragraph, with accompanying references for those who seek additional details. This new format is designed to lead AHA/ACC clinical practice guidelines into the electronic information management future.

“In the future, you’ll go to your iPad or iPhone or whatever, type in search terms such as ‘anticoagulation for mechanical valves during pregnancy,’ and it will take you straight to the relevant knowledge byte. You can then click on ‘more’ and find out more and get to the supporting evidence tables. The knowledge chunks will be stored in a centralized knowledge management system. The nice thing about this is that it will be a living document that can easily be updated, instead of having to wait 8 years for a new version,” Dr. Nishimura explained.

He reported having no financial conflicts of interest.

bjancin@frontlinemedcom.com

SNOWMASS, COLO. – The 2014 American Heart Association/American College of Cardiology guidelines for the management of valvular heart disease break new ground in numerous ways, Dr. Rick A. Nishimura said at the Annual Cardiovascular Conference at Snowmass.

“We needed to do things differently. These guidelines were created in a different format from prior valvular heart disease guidelines. We wanted these guidelines to promote access to concise, relevant bytes of information at the point of care,” explained Dr. Nishimura, professor of medicine at the Mayo Clinic in Rochester, Minn., and cochair of the guidelines writing committee.

These guidelines – the first major revision in 8 years – introduce a new taxonomy and the first staging system for valvular heart disease. The guidelines also lower the threshold for intervention in asymptomatic patients, recommending surgical or catheter-based treatment at an earlier point in the disease process than ever before. And the guidelines introduce the concept of heart valve centers of excellence, offering a strong recommendation that patients be referred to those centers for procedures to be performed in the asymptomatic phase of disease (J. Am. Coll. Cardiol. 2014;63:2438-88).

These valvular heart disease guidelines place greater emphasis than before on the quality of the scientific evidence underlying recommendations. Since valvular heart disease is a field with a paucity of randomized trials, that meant cutting back.

“Our goal was, if there’s little evidence, don’t write a recommendation. So the number of recommendations went down, but at least the ones that were made were based on evidence,” the cardiologist noted.

Indeed, in the 2006 guidelines, more than 70% of the recommendations were Level of Evidence C and based solely upon expert opinion; in the new guidelines, that’s true for less than 50%. And the proportion of recommendations that are Level of Evidence B increased from 30% to 45%.

The 2014 update was prompted by huge changes in the field of valvular heart disease since 2006. For example, better data became available on the natural history of valvular heart disease. The old concept was not to operate on the asymptomatic patient with severe aortic stenosis and normal left ventricular function, but more recent natural history studies have shown that, left untreated, 72% of such patients will die or develop symptoms within 5 years.

So there has been a push to intervene earlier. Fortunately, that became doable, as recent years also brought improved noninvasive imaging, new catheter-based interventions, and refined surgical methods, enabling operators to safely lower the threshold for intervention in asymptomatic patients while at the same time extending procedural therapies to older, sicker populations.

Dr. Nishimura predicted that cardiologists and surgeons will find the new staging system clinically useful. The four stages, A-D, define the categories “at risk,” “progressive,” “asymptomatic severe,” and “symptomatic severe,” respectively. These categories are particularly helpful in determining how often to schedule patient follow-up and when to time intervention.

The guidelines recommend observation for patients who are Stage A or B and intervention when reasonable in patients who are Stage C2 or D. What bumps a patient with hemodynamically severe yet asymptomatic mitral regurgitation from Stage C1 to C2 is an left ventricular ejection fraction below 60% or a left ventricular end systolic dimension of 40 mm or more. In the setting of asymptomatic aortic stenosis, it’s a peak aortic valve velocity of 4.0 m/sec on Doppler echocardiography plus an LVEF of less than 50%.

The latest guidelines introduced the concept of heart valve centers of excellence in response to evidence of large variability across the country in terms of experience with valve operations. For example, the majority of centers perform fewer than 40 mitral valve repairs per year, and surgeons who perform mitral operations do a median of just five per year. The guideline committee, which included general and interventional cardiologists, surgeons, anesthesiologists, and imaging experts, was persuaded that those numbers are not sufficient to achieve optimal results in complex valve operations for asymptomatic patients.

The criteria for qualifying as a heart valve center of excellence, as defined in the guidelines, include having a multidisciplinary heart valve team, high patient volume, high-level surgical experience and expertise in complex valve procedures, and active participation in multicenter data registries and continuous quality improvement processes.

“The most important thing is you have to be very transparent with your data,” according to the cardiologist.

Ultimately, the most far-reaching change introduced in the current valvular heart disease guidelines is the switch from textbook format to what Dr. Nishimura calls structured data knowledge management.

“The AHA/ACC clinical practice guidelines are generally recognized as the flagship of U.S. cardiovascular medicine, but they’re like a library of old books. Clinically valuable knowledge is buried within documents that can be 200 pages long. What we need at the point of care is the gist: concise, relevant bytes of information that answer a specific clinical question, synthesized by experts,” Dr. Nishimura said.

The new approach is designed to counter the information overload that plagues contemporary medical practice. Each recommendation in the current valvular heart disease guidelines addresses a specific clinical question via a brief summary statement followed by a short explanatory paragraph, with accompanying references for those who seek additional details. This new format is designed to lead AHA/ACC clinical practice guidelines into the electronic information management future.

“In the future, you’ll go to your iPad or iPhone or whatever, type in search terms such as ‘anticoagulation for mechanical valves during pregnancy,’ and it will take you straight to the relevant knowledge byte. You can then click on ‘more’ and find out more and get to the supporting evidence tables. The knowledge chunks will be stored in a centralized knowledge management system. The nice thing about this is that it will be a living document that can easily be updated, instead of having to wait 8 years for a new version,” Dr. Nishimura explained.

He reported having no financial conflicts of interest.

bjancin@frontlinemedcom.com

SNOWMASS, COLO. – The 2014 American Heart Association/American College of Cardiology guidelines for the management of valvular heart disease break new ground in numerous ways, Dr. Rick A. Nishimura said at the Annual Cardiovascular Conference at Snowmass.

“We needed to do things differently. These guidelines were created in a different format from prior valvular heart disease guidelines. We wanted these guidelines to promote access to concise, relevant bytes of information at the point of care,” explained Dr. Nishimura, professor of medicine at the Mayo Clinic in Rochester, Minn., and cochair of the guidelines writing committee.

These guidelines – the first major revision in 8 years – introduce a new taxonomy and the first staging system for valvular heart disease. The guidelines also lower the threshold for intervention in asymptomatic patients, recommending surgical or catheter-based treatment at an earlier point in the disease process than ever before. And the guidelines introduce the concept of heart valve centers of excellence, offering a strong recommendation that patients be referred to those centers for procedures to be performed in the asymptomatic phase of disease (J. Am. Coll. Cardiol. 2014;63:2438-88).

These valvular heart disease guidelines place greater emphasis than before on the quality of the scientific evidence underlying recommendations. Since valvular heart disease is a field with a paucity of randomized trials, that meant cutting back.

“Our goal was, if there’s little evidence, don’t write a recommendation. So the number of recommendations went down, but at least the ones that were made were based on evidence,” the cardiologist noted.

Indeed, in the 2006 guidelines, more than 70% of the recommendations were Level of Evidence C and based solely upon expert opinion; in the new guidelines, that’s true for less than 50%. And the proportion of recommendations that are Level of Evidence B increased from 30% to 45%.

The 2014 update was prompted by huge changes in the field of valvular heart disease since 2006. For example, better data became available on the natural history of valvular heart disease. The old concept was not to operate on the asymptomatic patient with severe aortic stenosis and normal left ventricular function, but more recent natural history studies have shown that, left untreated, 72% of such patients will die or develop symptoms within 5 years.

So there has been a push to intervene earlier. Fortunately, that became doable, as recent years also brought improved noninvasive imaging, new catheter-based interventions, and refined surgical methods, enabling operators to safely lower the threshold for intervention in asymptomatic patients while at the same time extending procedural therapies to older, sicker populations.

Dr. Nishimura predicted that cardiologists and surgeons will find the new staging system clinically useful. The four stages, A-D, define the categories “at risk,” “progressive,” “asymptomatic severe,” and “symptomatic severe,” respectively. These categories are particularly helpful in determining how often to schedule patient follow-up and when to time intervention.

The guidelines recommend observation for patients who are Stage A or B and intervention when reasonable in patients who are Stage C2 or D. What bumps a patient with hemodynamically severe yet asymptomatic mitral regurgitation from Stage C1 to C2 is an left ventricular ejection fraction below 60% or a left ventricular end systolic dimension of 40 mm or more. In the setting of asymptomatic aortic stenosis, it’s a peak aortic valve velocity of 4.0 m/sec on Doppler echocardiography plus an LVEF of less than 50%.

The latest guidelines introduced the concept of heart valve centers of excellence in response to evidence of large variability across the country in terms of experience with valve operations. For example, the majority of centers perform fewer than 40 mitral valve repairs per year, and surgeons who perform mitral operations do a median of just five per year. The guideline committee, which included general and interventional cardiologists, surgeons, anesthesiologists, and imaging experts, was persuaded that those numbers are not sufficient to achieve optimal results in complex valve operations for asymptomatic patients.

The criteria for qualifying as a heart valve center of excellence, as defined in the guidelines, include having a multidisciplinary heart valve team, high patient volume, high-level surgical experience and expertise in complex valve procedures, and active participation in multicenter data registries and continuous quality improvement processes.

“The most important thing is you have to be very transparent with your data,” according to the cardiologist.

Ultimately, the most far-reaching change introduced in the current valvular heart disease guidelines is the switch from textbook format to what Dr. Nishimura calls structured data knowledge management.

“The AHA/ACC clinical practice guidelines are generally recognized as the flagship of U.S. cardiovascular medicine, but they’re like a library of old books. Clinically valuable knowledge is buried within documents that can be 200 pages long. What we need at the point of care is the gist: concise, relevant bytes of information that answer a specific clinical question, synthesized by experts,” Dr. Nishimura said.

The new approach is designed to counter the information overload that plagues contemporary medical practice. Each recommendation in the current valvular heart disease guidelines addresses a specific clinical question via a brief summary statement followed by a short explanatory paragraph, with accompanying references for those who seek additional details. This new format is designed to lead AHA/ACC clinical practice guidelines into the electronic information management future.

“In the future, you’ll go to your iPad or iPhone or whatever, type in search terms such as ‘anticoagulation for mechanical valves during pregnancy,’ and it will take you straight to the relevant knowledge byte. You can then click on ‘more’ and find out more and get to the supporting evidence tables. The knowledge chunks will be stored in a centralized knowledge management system. The nice thing about this is that it will be a living document that can easily be updated, instead of having to wait 8 years for a new version,” Dr. Nishimura explained.

He reported having no financial conflicts of interest.

bjancin@frontlinemedcom.com