Naseem S. Miller

The American Heart Association has set aside a 5-year, $30-million research fund to dig deeper into two large national studies in hopes of finding more clues to personalized treatment and prevention of cardiovascular disease.

The organization and its two main collaborators, the University of Mississippi and Boston University, announced the new initiative during the AHA's annual scientific sessions.

"The collaboration has a vision of greatly expanding important population studies by adding more research subjects, more diverse subjects, more genetic analysis, and deeper new approaches to gathering information" leading toward personalized medicine, the AHA said in a news release.

The collaborative group, which has a temporary name of "Heart Studies v2.0," plans to analyze further the Framingham Heart Study, which is the longest-running U.S. heart study, and the Jackson Heart Study, which is the largest study to focus on risk factors among African Americans.

"The potential here is nothing short of amazing," Dr. Joseph Loscalzo, chair of the collaboration's Science Oversight Group, said in a statement. "The vast participant database from these important studies, plus additional genetic components, puts us on the path to finding specific risk determinants for certain cardiovascular diseases for every person."

In a video interview, Dr. Dan Jones, University of Mississippi chancellor and former Jackson Heart Study principle investigator, further explained the collaboration and its potential impact on practice.

The American Heart Association has set aside a 5-year, $30-million research fund to dig deeper into two large national studies in hopes of finding more clues to personalized treatment and prevention of cardiovascular disease.

The organization and its two main collaborators, the University of Mississippi and Boston University, announced the new initiative during the AHA's annual scientific sessions.

"The collaboration has a vision of greatly expanding important population studies by adding more research subjects, more diverse subjects, more genetic analysis, and deeper new approaches to gathering information" leading toward personalized medicine, the AHA said in a news release.

The collaborative group, which has a temporary name of "Heart Studies v2.0," plans to analyze further the Framingham Heart Study, which is the longest-running U.S. heart study, and the Jackson Heart Study, which is the largest study to focus on risk factors among African Americans.

"The potential here is nothing short of amazing," Dr. Joseph Loscalzo, chair of the collaboration's Science Oversight Group, said in a statement. "The vast participant database from these important studies, plus additional genetic components, puts us on the path to finding specific risk determinants for certain cardiovascular diseases for every person."

In a video interview, Dr. Dan Jones, University of Mississippi chancellor and former Jackson Heart Study principle investigator, further explained the collaboration and its potential impact on practice.

The American Heart Association has set aside a 5-year, $30-million research fund to dig deeper into two large national studies in hopes of finding more clues to personalized treatment and prevention of cardiovascular disease.

The organization and its two main collaborators, the University of Mississippi and Boston University, announced the new initiative during the AHA's annual scientific sessions.

"The collaboration has a vision of greatly expanding important population studies by adding more research subjects, more diverse subjects, more genetic analysis, and deeper new approaches to gathering information" leading toward personalized medicine, the AHA said in a news release.

The collaborative group, which has a temporary name of "Heart Studies v2.0," plans to analyze further the Framingham Heart Study, which is the longest-running U.S. heart study, and the Jackson Heart Study, which is the largest study to focus on risk factors among African Americans.

"The potential here is nothing short of amazing," Dr. Joseph Loscalzo, chair of the collaboration's Science Oversight Group, said in a statement. "The vast participant database from these important studies, plus additional genetic components, puts us on the path to finding specific risk determinants for certain cardiovascular diseases for every person."

In a video interview, Dr. Dan Jones, University of Mississippi chancellor and former Jackson Heart Study principle investigator, further explained the collaboration and its potential impact on practice.

The recent prevention guidelines issued by the American Heart Association and the American College of Cardiology became the center of some controversy during AHA's annual meeting, when word got out that a commentary by two researchers, saying that the guidelines' risk calculation formula is flawed, would be published in The Lancet*.

To respond to the comments by Dr. Paul M. Ridker and Ms. Nancy R. Cook, both from Brigham and Women’s Hospital in Boston, AHA and ACC officials held a press conference on Monday, November 18. This is the full audio of the statements made by the experts involved in the drafting of the guidelines.

*Updated:The Lancet article was published on Nov. 19.

@NaseemSMiller

The recent prevention guidelines issued by the American Heart Association and the American College of Cardiology became the center of some controversy during AHA's annual meeting, when word got out that a commentary by two researchers, saying that the guidelines' risk calculation formula is flawed, would be published in The Lancet*.

To respond to the comments by Dr. Paul M. Ridker and Ms. Nancy R. Cook, both from Brigham and Women’s Hospital in Boston, AHA and ACC officials held a press conference on Monday, November 18. This is the full audio of the statements made by the experts involved in the drafting of the guidelines.

*Updated:The Lancet article was published on Nov. 19.

@NaseemSMiller

The recent prevention guidelines issued by the American Heart Association and the American College of Cardiology became the center of some controversy during AHA's annual meeting, when word got out that a commentary by two researchers, saying that the guidelines' risk calculation formula is flawed, would be published in The Lancet*.

To respond to the comments by Dr. Paul M. Ridker and Ms. Nancy R. Cook, both from Brigham and Women’s Hospital in Boston, AHA and ACC officials held a press conference on Monday, November 18. This is the full audio of the statements made by the experts involved in the drafting of the guidelines.

*Updated:The Lancet article was published on Nov. 19.

@NaseemSMiller

ORLANDO – Half of the teens who made comments on social media about their feelings and caused concern among those who saw the comments were brought to the hospital for assessment, according to a small survey of adolescents admitted to the child and adolescent psychiatry unit of Ohio State University Harding Hospital, Columbus.

Tragic suicides or homicides after social media use have gained national attention in recent years, but studies like this highlight the flip side of social media platforms: They can make it easier to find out when teens are in distress and help them access timely treatment and support.

©audioundwerbung/iStockphoto

The fact that these teens turned to social media to express emotional stress, "shows that [they] are having trouble conveying emotions to parents, counselors, or friends, so they’re finding a different avenue," said Dr. Sathyan Gurumurthy, who presented the unpublished study at the annual meeting of the American Academy of Child and Adolescent Psychiatry. "So, as professionals, we have to gain a better understanding of how they convey emotions."

And given the generalized use of social media today, it is important for clinicians to ask children and adolescents about social media use during initial assessment, advised Dr. Gurumurthy, a resident physician at OSU’s Wexner Medical Center. "Talk to them about social media: how they use it and what sites they’re using," he said in an interview.

The results of the yearlong study are based on the 6-month data from an eight-question survey. Researchers were able to collect 32% of the surveys that were handed out to teens and their families at the time of admission.

Of the 82 patients who completed the survey, 54 (66%) said they had made a comment on social media about their emotional disturbance. Of those patients, 32 (60%) said their comments caused a concern, and 16 of those patients (50%) were brought to the hospital for assessment because of their comments.

Seventy-three teens were hospitalized for suicidal ideation; and they had confided mostly in friends, parents, or counselors (around 25 each). Six of the patients said that they had confided in an "Internet friend."

Half of these teens also said they preferred to communicate their suicidal thoughts in person, while 15% said they preferred social sites, and 9% preferred texts. Of the social sites, Facebook was the most popular (41%) among teens.

Of note was that only 25% circled "parent" as the person aware of their social media comments, said Dr. Gurumurthy.

"Many parents have minimal monitoring of their kids’ social media, and they have to be more involved in social media," he advised.

Dr. Gurumurthy said the group is still gathering data and hopes to increase the number of survey respondents. He said future studies gathering social media use data from outpatient and emergency department visits could reveal other possible correlations.

The authors had nothing to disclose.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

ORLANDO – Half of the teens who made comments on social media about their feelings and caused concern among those who saw the comments were brought to the hospital for assessment, according to a small survey of adolescents admitted to the child and adolescent psychiatry unit of Ohio State University Harding Hospital, Columbus.

Tragic suicides or homicides after social media use have gained national attention in recent years, but studies like this highlight the flip side of social media platforms: They can make it easier to find out when teens are in distress and help them access timely treatment and support.

©audioundwerbung/iStockphoto

The fact that these teens turned to social media to express emotional stress, "shows that [they] are having trouble conveying emotions to parents, counselors, or friends, so they’re finding a different avenue," said Dr. Sathyan Gurumurthy, who presented the unpublished study at the annual meeting of the American Academy of Child and Adolescent Psychiatry. "So, as professionals, we have to gain a better understanding of how they convey emotions."

And given the generalized use of social media today, it is important for clinicians to ask children and adolescents about social media use during initial assessment, advised Dr. Gurumurthy, a resident physician at OSU’s Wexner Medical Center. "Talk to them about social media: how they use it and what sites they’re using," he said in an interview.

The results of the yearlong study are based on the 6-month data from an eight-question survey. Researchers were able to collect 32% of the surveys that were handed out to teens and their families at the time of admission.

Of the 82 patients who completed the survey, 54 (66%) said they had made a comment on social media about their emotional disturbance. Of those patients, 32 (60%) said their comments caused a concern, and 16 of those patients (50%) were brought to the hospital for assessment because of their comments.

Seventy-three teens were hospitalized for suicidal ideation; and they had confided mostly in friends, parents, or counselors (around 25 each). Six of the patients said that they had confided in an "Internet friend."

Half of these teens also said they preferred to communicate their suicidal thoughts in person, while 15% said they preferred social sites, and 9% preferred texts. Of the social sites, Facebook was the most popular (41%) among teens.

Of note was that only 25% circled "parent" as the person aware of their social media comments, said Dr. Gurumurthy.

"Many parents have minimal monitoring of their kids’ social media, and they have to be more involved in social media," he advised.

Dr. Gurumurthy said the group is still gathering data and hopes to increase the number of survey respondents. He said future studies gathering social media use data from outpatient and emergency department visits could reveal other possible correlations.

The authors had nothing to disclose.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

ORLANDO – Half of the teens who made comments on social media about their feelings and caused concern among those who saw the comments were brought to the hospital for assessment, according to a small survey of adolescents admitted to the child and adolescent psychiatry unit of Ohio State University Harding Hospital, Columbus.

Tragic suicides or homicides after social media use have gained national attention in recent years, but studies like this highlight the flip side of social media platforms: They can make it easier to find out when teens are in distress and help them access timely treatment and support.

©audioundwerbung/iStockphoto

The fact that these teens turned to social media to express emotional stress, "shows that [they] are having trouble conveying emotions to parents, counselors, or friends, so they’re finding a different avenue," said Dr. Sathyan Gurumurthy, who presented the unpublished study at the annual meeting of the American Academy of Child and Adolescent Psychiatry. "So, as professionals, we have to gain a better understanding of how they convey emotions."

And given the generalized use of social media today, it is important for clinicians to ask children and adolescents about social media use during initial assessment, advised Dr. Gurumurthy, a resident physician at OSU’s Wexner Medical Center. "Talk to them about social media: how they use it and what sites they’re using," he said in an interview.

The results of the yearlong study are based on the 6-month data from an eight-question survey. Researchers were able to collect 32% of the surveys that were handed out to teens and their families at the time of admission.

Of the 82 patients who completed the survey, 54 (66%) said they had made a comment on social media about their emotional disturbance. Of those patients, 32 (60%) said their comments caused a concern, and 16 of those patients (50%) were brought to the hospital for assessment because of their comments.

Seventy-three teens were hospitalized for suicidal ideation; and they had confided mostly in friends, parents, or counselors (around 25 each). Six of the patients said that they had confided in an "Internet friend."

Half of these teens also said they preferred to communicate their suicidal thoughts in person, while 15% said they preferred social sites, and 9% preferred texts. Of the social sites, Facebook was the most popular (41%) among teens.

Of note was that only 25% circled "parent" as the person aware of their social media comments, said Dr. Gurumurthy.

"Many parents have minimal monitoring of their kids’ social media, and they have to be more involved in social media," he advised.

Dr. Gurumurthy said the group is still gathering data and hopes to increase the number of survey respondents. He said future studies gathering social media use data from outpatient and emergency department visits could reveal other possible correlations.

The authors had nothing to disclose.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

ORLANDO – When it comes to popularity and use, e-cigarettes are finding their place in high schools, and some teens believe that the product is safer than other forms of tobacco, according to a survey in an urban North Carolina county, which attempted to get a snapshot of teenagers’ beliefs and attitudes toward this growing trend.

Proponents of e-cigarettes say that the product is safer than tobacco smoking and can be used for smoking cessation, but opponents say that they’re a gateway to nicotine addiction. There are no long-term data on their safety, and it’s still not clear if they’re effective for smoking cessation.

But the use of e-cigarettes has doubled among high school students between 2011 and 2012, wrote Dr. Vivek Anand of East Carolina University, Greenville, N.C., and his colleagues, who presented their unpublished study at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

Researchers surveyed 3,200 high school students in an urban county in North Carolina about the use, knowledge, attitudes, and beliefs about e-cigarettes.

©timur1970/Fotolia.com

Roughly 85% of the students completed the survey. The mean age was 16.4 years old, the majority (44%) were black, 38% white, and 8.2% Mexican American.

About 15% of the students said they had used e-cigarettes in their lifetime, compared with 25% who had smoked cigarettes, and 13% who used smokeless tobacco. Meanwhile, 7.4% said they had used e-cigarettes during the past 30 days, compared with 15% who had smoked cigarettes, and 10% who had used smokeless tobacco.

Also, friends were the most common source of e-cigarettes (36%), compared with 24% from a tobacco store, 17% from a gas station, and 2% from a pharmacy. Meanwhile, having a family member who used tobacco products was associated with increased risk of using e-cigarettes, while being female, planning to graduate, and not knowing any e-cigarette users had a protective effect.

Significantly more e-cigarette users also found the product to be a safer route of nicotine administration, compared with teens who did not use e-cigarettes (35% v. 3%).

Researchers also found that a majority of respondents weren’t aware of quitting resources available through their high school. “This is alarming, given that e-cigarettes are perceived as healthier than other tobacco products,” Dr. Anand and his colleagues wrote. “E-cigarette users may be trying to stop smoking and could be an important population to target for evidence-based tobacco treatment interventions.”

E-cigarettes, which are powered by batteries, have a sensor that detects airflow and activates a heating element, which then vaporizes a nicotine solution.

Both the World Health Organization and the Food and Drug Administration have said that evidence about the safety of e-cigarettes is lacking, and they’ve encouraged the makers to stop making therapeutic claims. Dozens of states have banned e-cigarette sale to minors, and more are working on posing similar laws.

Dr. Anand and his colleagues said that their survey was the first large-scale study of high school students’ knowledge, attitudes, perceptions, and beliefs about e-cigarettes.

“Identification of subgroups of adolescents at highest risk for e-cigarette use, such as those whose family and friends use tobacco could guide early identification of youth at risk,” they wrote.

Dr. Anand and his colleagues had nothing to disclosure. Their study was funded by the National Institute on Drug Abuse.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

ORLANDO – When it comes to popularity and use, e-cigarettes are finding their place in high schools, and some teens believe that the product is safer than other forms of tobacco, according to a survey in an urban North Carolina county, which attempted to get a snapshot of teenagers’ beliefs and attitudes toward this growing trend.

Proponents of e-cigarettes say that the product is safer than tobacco smoking and can be used for smoking cessation, but opponents say that they’re a gateway to nicotine addiction. There are no long-term data on their safety, and it’s still not clear if they’re effective for smoking cessation.

But the use of e-cigarettes has doubled among high school students between 2011 and 2012, wrote Dr. Vivek Anand of East Carolina University, Greenville, N.C., and his colleagues, who presented their unpublished study at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

Researchers surveyed 3,200 high school students in an urban county in North Carolina about the use, knowledge, attitudes, and beliefs about e-cigarettes.

©timur1970/Fotolia.com

Roughly 85% of the students completed the survey. The mean age was 16.4 years old, the majority (44%) were black, 38% white, and 8.2% Mexican American.

About 15% of the students said they had used e-cigarettes in their lifetime, compared with 25% who had smoked cigarettes, and 13% who used smokeless tobacco. Meanwhile, 7.4% said they had used e-cigarettes during the past 30 days, compared with 15% who had smoked cigarettes, and 10% who had used smokeless tobacco.

Also, friends were the most common source of e-cigarettes (36%), compared with 24% from a tobacco store, 17% from a gas station, and 2% from a pharmacy. Meanwhile, having a family member who used tobacco products was associated with increased risk of using e-cigarettes, while being female, planning to graduate, and not knowing any e-cigarette users had a protective effect.

Significantly more e-cigarette users also found the product to be a safer route of nicotine administration, compared with teens who did not use e-cigarettes (35% v. 3%).

Researchers also found that a majority of respondents weren’t aware of quitting resources available through their high school. “This is alarming, given that e-cigarettes are perceived as healthier than other tobacco products,” Dr. Anand and his colleagues wrote. “E-cigarette users may be trying to stop smoking and could be an important population to target for evidence-based tobacco treatment interventions.”

E-cigarettes, which are powered by batteries, have a sensor that detects airflow and activates a heating element, which then vaporizes a nicotine solution.

Both the World Health Organization and the Food and Drug Administration have said that evidence about the safety of e-cigarettes is lacking, and they’ve encouraged the makers to stop making therapeutic claims. Dozens of states have banned e-cigarette sale to minors, and more are working on posing similar laws.

Dr. Anand and his colleagues said that their survey was the first large-scale study of high school students’ knowledge, attitudes, perceptions, and beliefs about e-cigarettes.

“Identification of subgroups of adolescents at highest risk for e-cigarette use, such as those whose family and friends use tobacco could guide early identification of youth at risk,” they wrote.

Dr. Anand and his colleagues had nothing to disclosure. Their study was funded by the National Institute on Drug Abuse.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

ORLANDO – When it comes to popularity and use, e-cigarettes are finding their place in high schools, and some teens believe that the product is safer than other forms of tobacco, according to a survey in an urban North Carolina county, which attempted to get a snapshot of teenagers’ beliefs and attitudes toward this growing trend.

Proponents of e-cigarettes say that the product is safer than tobacco smoking and can be used for smoking cessation, but opponents say that they’re a gateway to nicotine addiction. There are no long-term data on their safety, and it’s still not clear if they’re effective for smoking cessation.

But the use of e-cigarettes has doubled among high school students between 2011 and 2012, wrote Dr. Vivek Anand of East Carolina University, Greenville, N.C., and his colleagues, who presented their unpublished study at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

Researchers surveyed 3,200 high school students in an urban county in North Carolina about the use, knowledge, attitudes, and beliefs about e-cigarettes.

©timur1970/Fotolia.com

Roughly 85% of the students completed the survey. The mean age was 16.4 years old, the majority (44%) were black, 38% white, and 8.2% Mexican American.

About 15% of the students said they had used e-cigarettes in their lifetime, compared with 25% who had smoked cigarettes, and 13% who used smokeless tobacco. Meanwhile, 7.4% said they had used e-cigarettes during the past 30 days, compared with 15% who had smoked cigarettes, and 10% who had used smokeless tobacco.

Also, friends were the most common source of e-cigarettes (36%), compared with 24% from a tobacco store, 17% from a gas station, and 2% from a pharmacy. Meanwhile, having a family member who used tobacco products was associated with increased risk of using e-cigarettes, while being female, planning to graduate, and not knowing any e-cigarette users had a protective effect.

Significantly more e-cigarette users also found the product to be a safer route of nicotine administration, compared with teens who did not use e-cigarettes (35% v. 3%).

Researchers also found that a majority of respondents weren’t aware of quitting resources available through their high school. “This is alarming, given that e-cigarettes are perceived as healthier than other tobacco products,” Dr. Anand and his colleagues wrote. “E-cigarette users may be trying to stop smoking and could be an important population to target for evidence-based tobacco treatment interventions.”

E-cigarettes, which are powered by batteries, have a sensor that detects airflow and activates a heating element, which then vaporizes a nicotine solution.

Both the World Health Organization and the Food and Drug Administration have said that evidence about the safety of e-cigarettes is lacking, and they’ve encouraged the makers to stop making therapeutic claims. Dozens of states have banned e-cigarette sale to minors, and more are working on posing similar laws.

Dr. Anand and his colleagues said that their survey was the first large-scale study of high school students’ knowledge, attitudes, perceptions, and beliefs about e-cigarettes.

“Identification of subgroups of adolescents at highest risk for e-cigarette use, such as those whose family and friends use tobacco could guide early identification of youth at risk,” they wrote.

Dr. Anand and his colleagues had nothing to disclosure. Their study was funded by the National Institute on Drug Abuse.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

ORLANDO – History of self-harm and suicidal ideation are two strong indicators that a teen with bipolar disorder might attempt suicide, according to an unpublished Canadian study presented at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

Identifying such clinical features is important as they can help with intervention and prevention of suicide among teens with bipolar disorder, the researchers wrote.

Previous studies have shown that adults with bipolar disorder (BD) are at a higher risk of completing suicide – as many as 25%-50% of them make at least one suicide attempt in their lifetime, and up to 20% complete the attempt.

Meanwhile, studies of pediatric patients have shown a lifetime suicide attempt rate of 20%-50%. Yet there is limited research on teens, Dr. Benjamin I. Goldstein of Sunnybrook Health Sciences Centre, Toronto, and his colleagues wrote in their poster.

A 2013 systemic review of suicidal ideation and suicide attempts by children and teenagers with bipolar disorder showed that the issue is underinvestigated. "Exploration of predictors and protective factors is imperative for the establishment of effective preventive and intervention strategies, which are urgently needed," researchers at Zucker Hillside Hospital, Glen Oaks, N.Y., wrote (Bipolar Disord. 2013;15:507-23).

Dr. Goldstein and his colleagues studied 72 teenagers aged 13-19 years who had bipolar I disorder, bipolar II disorder, or bipolar disorder not otherwise specified.

The 20% of patients who reported having attempted suicide were significantly more likely to be female and to have lower socioeconomic status, more self-harm behavior, suicide ideation, a lifetime history of conduct disorder, bulimia nervosa, lifetime lamotrigine use, and a family history of suicide attempts. That’s compared with teens who did not attempt a suicide.

The multivariate analyses showed that history of self-injurious behavior and family history of suicide attempts was strongly associated with suicide attempts. And when comparing the findings from previous studies and the current study, the researchers found that they all shared history of self-injurious behavior and suicidal ideation.

The analyses had limited power to detect small effect sizes, and "the cross-sectional methodology precludes conclusions regarding the directionality of the observed associations," Dr. Goldstein and his colleagues wrote.

They added that future studies should examine whether the characteristics found in the study can be incorporated in assessment and treatment of youth with bipolar disorder to help reduce the risk of suicide in this high-risk population.

Dr. Goldstein is a consultant for Bristol-Myers Squibb and has received honoraria from Purdue Pharma.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

ORLANDO – History of self-harm and suicidal ideation are two strong indicators that a teen with bipolar disorder might attempt suicide, according to an unpublished Canadian study presented at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

Identifying such clinical features is important as they can help with intervention and prevention of suicide among teens with bipolar disorder, the researchers wrote.

Previous studies have shown that adults with bipolar disorder (BD) are at a higher risk of completing suicide – as many as 25%-50% of them make at least one suicide attempt in their lifetime, and up to 20% complete the attempt.

Meanwhile, studies of pediatric patients have shown a lifetime suicide attempt rate of 20%-50%. Yet there is limited research on teens, Dr. Benjamin I. Goldstein of Sunnybrook Health Sciences Centre, Toronto, and his colleagues wrote in their poster.

A 2013 systemic review of suicidal ideation and suicide attempts by children and teenagers with bipolar disorder showed that the issue is underinvestigated. "Exploration of predictors and protective factors is imperative for the establishment of effective preventive and intervention strategies, which are urgently needed," researchers at Zucker Hillside Hospital, Glen Oaks, N.Y., wrote (Bipolar Disord. 2013;15:507-23).

Dr. Goldstein and his colleagues studied 72 teenagers aged 13-19 years who had bipolar I disorder, bipolar II disorder, or bipolar disorder not otherwise specified.

The 20% of patients who reported having attempted suicide were significantly more likely to be female and to have lower socioeconomic status, more self-harm behavior, suicide ideation, a lifetime history of conduct disorder, bulimia nervosa, lifetime lamotrigine use, and a family history of suicide attempts. That’s compared with teens who did not attempt a suicide.

The multivariate analyses showed that history of self-injurious behavior and family history of suicide attempts was strongly associated with suicide attempts. And when comparing the findings from previous studies and the current study, the researchers found that they all shared history of self-injurious behavior and suicidal ideation.

The analyses had limited power to detect small effect sizes, and "the cross-sectional methodology precludes conclusions regarding the directionality of the observed associations," Dr. Goldstein and his colleagues wrote.

They added that future studies should examine whether the characteristics found in the study can be incorporated in assessment and treatment of youth with bipolar disorder to help reduce the risk of suicide in this high-risk population.

Dr. Goldstein is a consultant for Bristol-Myers Squibb and has received honoraria from Purdue Pharma.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

ORLANDO – History of self-harm and suicidal ideation are two strong indicators that a teen with bipolar disorder might attempt suicide, according to an unpublished Canadian study presented at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

Identifying such clinical features is important as they can help with intervention and prevention of suicide among teens with bipolar disorder, the researchers wrote.

Previous studies have shown that adults with bipolar disorder (BD) are at a higher risk of completing suicide – as many as 25%-50% of them make at least one suicide attempt in their lifetime, and up to 20% complete the attempt.

Meanwhile, studies of pediatric patients have shown a lifetime suicide attempt rate of 20%-50%. Yet there is limited research on teens, Dr. Benjamin I. Goldstein of Sunnybrook Health Sciences Centre, Toronto, and his colleagues wrote in their poster.

A 2013 systemic review of suicidal ideation and suicide attempts by children and teenagers with bipolar disorder showed that the issue is underinvestigated. "Exploration of predictors and protective factors is imperative for the establishment of effective preventive and intervention strategies, which are urgently needed," researchers at Zucker Hillside Hospital, Glen Oaks, N.Y., wrote (Bipolar Disord. 2013;15:507-23).

Dr. Goldstein and his colleagues studied 72 teenagers aged 13-19 years who had bipolar I disorder, bipolar II disorder, or bipolar disorder not otherwise specified.

The 20% of patients who reported having attempted suicide were significantly more likely to be female and to have lower socioeconomic status, more self-harm behavior, suicide ideation, a lifetime history of conduct disorder, bulimia nervosa, lifetime lamotrigine use, and a family history of suicide attempts. That’s compared with teens who did not attempt a suicide.

The multivariate analyses showed that history of self-injurious behavior and family history of suicide attempts was strongly associated with suicide attempts. And when comparing the findings from previous studies and the current study, the researchers found that they all shared history of self-injurious behavior and suicidal ideation.

The analyses had limited power to detect small effect sizes, and "the cross-sectional methodology precludes conclusions regarding the directionality of the observed associations," Dr. Goldstein and his colleagues wrote.

They added that future studies should examine whether the characteristics found in the study can be incorporated in assessment and treatment of youth with bipolar disorder to help reduce the risk of suicide in this high-risk population.

Dr. Goldstein is a consultant for Bristol-Myers Squibb and has received honoraria from Purdue Pharma.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

AMSTERDAM – A study of Japanese patients with hypertension and glucose intolerance showed that as their body mass index increased, their risk of cardiovascular disease decreased, suggesting the existence of the obesity paradox in this particular population of patients.

However, these findings results don’t refute the fact that severe obesity is a risk factor for cardiovascular disease, and that "hypertensive patients with glucose intolerance and a high BMI [body mass index] should lose weight and restore their BMI to normal range," Dr. Takanori Nagahiro said at the annual congress of the European Society of Cardiology.

Furthermore, the results should be interpreted with caution, because the insulin therapy was higher among patients at the lowest BMI category, indicating that the severity of diabetes may have been different in that group, said Dr. Nagahiro of Nagoya (Japan) University.

The study was a subanalysis of the NAGOYA HEART (Novel Antihypertensive Goal of Hypertension With Diabetes – Hypertensive Events and ARB Treatment) study, which compared the effects of an angiotensin II receptor blocker with a calcium channel blocker on cardiovascular outcomes in 1,150 hypertensive patients with type 2 diabetes or impaired glucose tolerance. No significant differences were found between the two classes. The median follow-up was 3.2 years (Hypertension 2012;59:580-6).

For the current analysis, patients were divided into quartiles according to their body mass indices: Patients in quartile 1 (Q1) had BMIs lower than 23.5 kg/m² (283 patients); those in Q2 had a BMI range of 23.5-25 (290); those in Q3 had a range of 25-27.5 (277); and patients in Q4 had BMIs higher than 27.5 (255).

The primary outcome in the subanalysis, as in the main study, was a composite of acute myocardial infarction, stroke, admission for heart failure, coronary revascularization, or sudden cardiac death.

There were no significant differences between the four groups, except for age and insulin therapy, where the lowest BMI group had the highest rate of insulin therapy (11%, compared with 6.2%, 4.7%, and 4.7% in Q2, Q3, and Q4, respectively.)

Forty-two (15%; 4.6/100 person-years) patients reached the primary endpoint in Q1, which was used as reference. In Q2, 24 patients (8.3%; 2.3) reached the primary endpoint; and in Q3, 27 patients (9.7%; 2.8) reached the endpoint, both nonsignificant differences. In Q4, however, 13 patients (5.1%; 1.5) reached the endpoint, a significant difference from Q1.

"I think the picture is quite clear now, that metabolic disorders are more important than obesity per se especially if you measure it by body mass index," said Dr. Heinz Drexel, chairman of the department of medicine and cardiology and of the VIVIT Institute, Academic Teaching Hospital Feldkirch, Austria, who cochaired the session at ESC. "I think that’s the bottom line."

The NAGOYA HEART study was funded by Nagoya University, which has received unrestricted research grants from several companies, including Astellas, Bayer, Pfizer, Sanofi-Aventis, and Takeda. Dr. Drexel had no disclosures.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

AMSTERDAM – A study of Japanese patients with hypertension and glucose intolerance showed that as their body mass index increased, their risk of cardiovascular disease decreased, suggesting the existence of the obesity paradox in this particular population of patients.

However, these findings results don’t refute the fact that severe obesity is a risk factor for cardiovascular disease, and that "hypertensive patients with glucose intolerance and a high BMI [body mass index] should lose weight and restore their BMI to normal range," Dr. Takanori Nagahiro said at the annual congress of the European Society of Cardiology.

Furthermore, the results should be interpreted with caution, because the insulin therapy was higher among patients at the lowest BMI category, indicating that the severity of diabetes may have been different in that group, said Dr. Nagahiro of Nagoya (Japan) University.

The study was a subanalysis of the NAGOYA HEART (Novel Antihypertensive Goal of Hypertension With Diabetes – Hypertensive Events and ARB Treatment) study, which compared the effects of an angiotensin II receptor blocker with a calcium channel blocker on cardiovascular outcomes in 1,150 hypertensive patients with type 2 diabetes or impaired glucose tolerance. No significant differences were found between the two classes. The median follow-up was 3.2 years (Hypertension 2012;59:580-6).

For the current analysis, patients were divided into quartiles according to their body mass indices: Patients in quartile 1 (Q1) had BMIs lower than 23.5 kg/m² (283 patients); those in Q2 had a BMI range of 23.5-25 (290); those in Q3 had a range of 25-27.5 (277); and patients in Q4 had BMIs higher than 27.5 (255).

The primary outcome in the subanalysis, as in the main study, was a composite of acute myocardial infarction, stroke, admission for heart failure, coronary revascularization, or sudden cardiac death.

There were no significant differences between the four groups, except for age and insulin therapy, where the lowest BMI group had the highest rate of insulin therapy (11%, compared with 6.2%, 4.7%, and 4.7% in Q2, Q3, and Q4, respectively.)

Forty-two (15%; 4.6/100 person-years) patients reached the primary endpoint in Q1, which was used as reference. In Q2, 24 patients (8.3%; 2.3) reached the primary endpoint; and in Q3, 27 patients (9.7%; 2.8) reached the endpoint, both nonsignificant differences. In Q4, however, 13 patients (5.1%; 1.5) reached the endpoint, a significant difference from Q1.

"I think the picture is quite clear now, that metabolic disorders are more important than obesity per se especially if you measure it by body mass index," said Dr. Heinz Drexel, chairman of the department of medicine and cardiology and of the VIVIT Institute, Academic Teaching Hospital Feldkirch, Austria, who cochaired the session at ESC. "I think that’s the bottom line."

The NAGOYA HEART study was funded by Nagoya University, which has received unrestricted research grants from several companies, including Astellas, Bayer, Pfizer, Sanofi-Aventis, and Takeda. Dr. Drexel had no disclosures.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

AMSTERDAM – A study of Japanese patients with hypertension and glucose intolerance showed that as their body mass index increased, their risk of cardiovascular disease decreased, suggesting the existence of the obesity paradox in this particular population of patients.

However, these findings results don’t refute the fact that severe obesity is a risk factor for cardiovascular disease, and that "hypertensive patients with glucose intolerance and a high BMI [body mass index] should lose weight and restore their BMI to normal range," Dr. Takanori Nagahiro said at the annual congress of the European Society of Cardiology.

Furthermore, the results should be interpreted with caution, because the insulin therapy was higher among patients at the lowest BMI category, indicating that the severity of diabetes may have been different in that group, said Dr. Nagahiro of Nagoya (Japan) University.

The study was a subanalysis of the NAGOYA HEART (Novel Antihypertensive Goal of Hypertension With Diabetes – Hypertensive Events and ARB Treatment) study, which compared the effects of an angiotensin II receptor blocker with a calcium channel blocker on cardiovascular outcomes in 1,150 hypertensive patients with type 2 diabetes or impaired glucose tolerance. No significant differences were found between the two classes. The median follow-up was 3.2 years (Hypertension 2012;59:580-6).

For the current analysis, patients were divided into quartiles according to their body mass indices: Patients in quartile 1 (Q1) had BMIs lower than 23.5 kg/m² (283 patients); those in Q2 had a BMI range of 23.5-25 (290); those in Q3 had a range of 25-27.5 (277); and patients in Q4 had BMIs higher than 27.5 (255).

The primary outcome in the subanalysis, as in the main study, was a composite of acute myocardial infarction, stroke, admission for heart failure, coronary revascularization, or sudden cardiac death.

There were no significant differences between the four groups, except for age and insulin therapy, where the lowest BMI group had the highest rate of insulin therapy (11%, compared with 6.2%, 4.7%, and 4.7% in Q2, Q3, and Q4, respectively.)

Forty-two (15%; 4.6/100 person-years) patients reached the primary endpoint in Q1, which was used as reference. In Q2, 24 patients (8.3%; 2.3) reached the primary endpoint; and in Q3, 27 patients (9.7%; 2.8) reached the endpoint, both nonsignificant differences. In Q4, however, 13 patients (5.1%; 1.5) reached the endpoint, a significant difference from Q1.

"I think the picture is quite clear now, that metabolic disorders are more important than obesity per se especially if you measure it by body mass index," said Dr. Heinz Drexel, chairman of the department of medicine and cardiology and of the VIVIT Institute, Academic Teaching Hospital Feldkirch, Austria, who cochaired the session at ESC. "I think that’s the bottom line."

The NAGOYA HEART study was funded by Nagoya University, which has received unrestricted research grants from several companies, including Astellas, Bayer, Pfizer, Sanofi-Aventis, and Takeda. Dr. Drexel had no disclosures.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

ORLANDO – More women than men died during the first year of being on the heart transplant waiting list, and the disparity may be influenced by the difference in the use of life-saving therapies, according to a 12-year analysis of a national database.

After adjusting for several variables, researchers found that female gender was associated with a 10% increased risk of being removed from the waiting list because the women died or were deemed too sick during the first year. When the researchers added implantable cardioverter defibrillator use to the analysis, that risk was attenuated to 8%, although still significant, but adding ICDs and left ventricular assist devices (LVADs) eliminated the risk associated with the female gender, said Dr. Alanna Morris of Emory University, Atlanta.

The study, which looked at the Organ Procurement and Transplantation Network (OPTN) database, showed that women on the waiting list were significantly less likely to have an ICD (55% vs. 64%; P less than .001), or a ventricular assist device (24% vs. 30%; P less than .001) than were men, said Dr. Morris, who presented her unpublished abstract at the annual meeting of the Heart Failure Society of America.

The finding is in line with studies that have shown significantly lower rates of ICD implantation among women with end-stage heart failure, compared with men. Research has also shown that women are less likely to be referred for LVAD implantation, even though no survival difference between genders while on LVAD support has been observed, the authors noted.

Meanwhile, the proportion of women on the wait list has increased by more than 4% in the past decade, but studies on women’s survival while on wait lists have shown conflicting results, the researchers added.

They identified nearly 27,000 adult patients (23% were women) in the OPTN database between January 2000 and September 2012, who were listed for their first heart transplant.

There were several statistically significant differences between genders at baseline, aside from ICD and LVAD use. Female heart transplant candidates were younger (52 vs. 56 years), were less likely to have diabetes (21% vs. 27%), were less likely to have a normal glomerular filtration rate (49% vs. 53%), had a lower pulmonary capillary wedge pressure (20 vs. 21 mm Hg), and had fewer median days (67 vs. 84) on a wait list (P less than .001 for all).

The 1-year unadjusted survival rate in women on the waiting list was significantly lower, at 70%, than in men, at 73% (P = .006).

After adjustment for age, race, blood type, and support with extracorporeal membrane oxygenation or intra-aortic balloon pump, female gender was still associated with a higher risk of the primary end point, which was removal from the wait list due to death or being deemed too sick to transplant at 1 year (hazard ratio 1.10; P = .026), the authors reported.

But, after adjustment for ICD and LVAD use, the gender gap was eliminated (HR 1.06; P = .2).

Dr. Morris said that a more aggressive use of these life-saving therapies can eliminate wait-list disparities. The findings also point to the importance of educating community physicians and heart failure patients about the current standards of care, she said.

Changes in the allocation algorithm and improvements in LVAD technology have led to advancements in management of patients on heart transplant waiting lists, the authors said. Between 2001 and 2011, wait list mortality declined from 17 deaths per 100 wait-list years, to 12 deaths. During the same period, wait-list death among patients with an LVAD declined from 102 deaths per 100 wait-list years to 13.

Dr. Morris had no financial relationships to disclose.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

ORLANDO – More women than men died during the first year of being on the heart transplant waiting list, and the disparity may be influenced by the difference in the use of life-saving therapies, according to a 12-year analysis of a national database.

After adjusting for several variables, researchers found that female gender was associated with a 10% increased risk of being removed from the waiting list because the women died or were deemed too sick during the first year. When the researchers added implantable cardioverter defibrillator use to the analysis, that risk was attenuated to 8%, although still significant, but adding ICDs and left ventricular assist devices (LVADs) eliminated the risk associated with the female gender, said Dr. Alanna Morris of Emory University, Atlanta.

The study, which looked at the Organ Procurement and Transplantation Network (OPTN) database, showed that women on the waiting list were significantly less likely to have an ICD (55% vs. 64%; P less than .001), or a ventricular assist device (24% vs. 30%; P less than .001) than were men, said Dr. Morris, who presented her unpublished abstract at the annual meeting of the Heart Failure Society of America.

The finding is in line with studies that have shown significantly lower rates of ICD implantation among women with end-stage heart failure, compared with men. Research has also shown that women are less likely to be referred for LVAD implantation, even though no survival difference between genders while on LVAD support has been observed, the authors noted.

Meanwhile, the proportion of women on the wait list has increased by more than 4% in the past decade, but studies on women’s survival while on wait lists have shown conflicting results, the researchers added.

They identified nearly 27,000 adult patients (23% were women) in the OPTN database between January 2000 and September 2012, who were listed for their first heart transplant.

There were several statistically significant differences between genders at baseline, aside from ICD and LVAD use. Female heart transplant candidates were younger (52 vs. 56 years), were less likely to have diabetes (21% vs. 27%), were less likely to have a normal glomerular filtration rate (49% vs. 53%), had a lower pulmonary capillary wedge pressure (20 vs. 21 mm Hg), and had fewer median days (67 vs. 84) on a wait list (P less than .001 for all).

The 1-year unadjusted survival rate in women on the waiting list was significantly lower, at 70%, than in men, at 73% (P = .006).

After adjustment for age, race, blood type, and support with extracorporeal membrane oxygenation or intra-aortic balloon pump, female gender was still associated with a higher risk of the primary end point, which was removal from the wait list due to death or being deemed too sick to transplant at 1 year (hazard ratio 1.10; P = .026), the authors reported.

But, after adjustment for ICD and LVAD use, the gender gap was eliminated (HR 1.06; P = .2).

Dr. Morris said that a more aggressive use of these life-saving therapies can eliminate wait-list disparities. The findings also point to the importance of educating community physicians and heart failure patients about the current standards of care, she said.

Changes in the allocation algorithm and improvements in LVAD technology have led to advancements in management of patients on heart transplant waiting lists, the authors said. Between 2001 and 2011, wait list mortality declined from 17 deaths per 100 wait-list years, to 12 deaths. During the same period, wait-list death among patients with an LVAD declined from 102 deaths per 100 wait-list years to 13.

Dr. Morris had no financial relationships to disclose.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

ORLANDO – More women than men died during the first year of being on the heart transplant waiting list, and the disparity may be influenced by the difference in the use of life-saving therapies, according to a 12-year analysis of a national database.

After adjusting for several variables, researchers found that female gender was associated with a 10% increased risk of being removed from the waiting list because the women died or were deemed too sick during the first year. When the researchers added implantable cardioverter defibrillator use to the analysis, that risk was attenuated to 8%, although still significant, but adding ICDs and left ventricular assist devices (LVADs) eliminated the risk associated with the female gender, said Dr. Alanna Morris of Emory University, Atlanta.

The study, which looked at the Organ Procurement and Transplantation Network (OPTN) database, showed that women on the waiting list were significantly less likely to have an ICD (55% vs. 64%; P less than .001), or a ventricular assist device (24% vs. 30%; P less than .001) than were men, said Dr. Morris, who presented her unpublished abstract at the annual meeting of the Heart Failure Society of America.

The finding is in line with studies that have shown significantly lower rates of ICD implantation among women with end-stage heart failure, compared with men. Research has also shown that women are less likely to be referred for LVAD implantation, even though no survival difference between genders while on LVAD support has been observed, the authors noted.

Meanwhile, the proportion of women on the wait list has increased by more than 4% in the past decade, but studies on women’s survival while on wait lists have shown conflicting results, the researchers added.

They identified nearly 27,000 adult patients (23% were women) in the OPTN database between January 2000 and September 2012, who were listed for their first heart transplant.

There were several statistically significant differences between genders at baseline, aside from ICD and LVAD use. Female heart transplant candidates were younger (52 vs. 56 years), were less likely to have diabetes (21% vs. 27%), were less likely to have a normal glomerular filtration rate (49% vs. 53%), had a lower pulmonary capillary wedge pressure (20 vs. 21 mm Hg), and had fewer median days (67 vs. 84) on a wait list (P less than .001 for all).

The 1-year unadjusted survival rate in women on the waiting list was significantly lower, at 70%, than in men, at 73% (P = .006).

After adjustment for age, race, blood type, and support with extracorporeal membrane oxygenation or intra-aortic balloon pump, female gender was still associated with a higher risk of the primary end point, which was removal from the wait list due to death or being deemed too sick to transplant at 1 year (hazard ratio 1.10; P = .026), the authors reported.

But, after adjustment for ICD and LVAD use, the gender gap was eliminated (HR 1.06; P = .2).

Dr. Morris said that a more aggressive use of these life-saving therapies can eliminate wait-list disparities. The findings also point to the importance of educating community physicians and heart failure patients about the current standards of care, she said.

Changes in the allocation algorithm and improvements in LVAD technology have led to advancements in management of patients on heart transplant waiting lists, the authors said. Between 2001 and 2011, wait list mortality declined from 17 deaths per 100 wait-list years, to 12 deaths. During the same period, wait-list death among patients with an LVAD declined from 102 deaths per 100 wait-list years to 13.

Dr. Morris had no financial relationships to disclose.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

AMSTERDAM – An implant-based remote monitoring system in patients with advanced heart failure significantly reduced the worsening of their condition, overnight hospitalization, and total mortality, according to a trial conducted by the device-maker.

The IN-TIME study, a multicenter, prospective, randomized, controlled trial, showed that the mortality at 1 year follow-up was 3.4% in the home monitoring group, compared with 8.7% in patients with standard care. This is the first time a home monitoring trial has shown a significant drop in death rate.

"IN-TIME is really a timely study," said Dr. Angelo Auricchio of Lugano, Switzerland, because the study coincides with the most recent ESC guidelines for CRT and pacemakers, which for the very first time contain recommendation for remote monitoring. Dr. Auricchio was one of the guideline’s authors.

Rehospitalization or death resulting from worsening heart failure are often preceded by clinical events or specific trends in clinical parameters. Use of home monitoring can detect some of these events and trends early, "offering the possibility to intervene and prevent hospitalization for worsening heart failure," said Dr. Gerhard Hindricks, the lead investigator of the trial, who presented the results at the annual congress of the European Society of Cardiology.

Findings from other trials, including TRUST and REFORM have hinted at the benefits of remote monitoring, but they didn’t show the significant results seen with IN-TIME.

Patients received Biotronik’s ICD or CRT-D equipped with home monitoring software. The device detects biological signals, such as heart rate, occurrence of arrhythmias, onset of arrhythmia or shocks, and transmits the signals to a small external patient communicator called Cardio Messenger, which in turn sends the signals to a centralized monitoring unit in Heart Center Leipzig, Germany.

"Trained nursing staff took the incoming data, and then activated a chain of action according to prespecified workflows,\" said Dr. Hindricks of University of Leipzig. In some cases, if the physician was not available, the providers would directly contact the patient to advise a follow-up with a general practitioner or appropriate clinic. The physician would also enter the information about the measure taken into the centralized monitoring system.

Researchers randomized 664 patients – 1:1, with no crossover – to either home monitoring (333) or standard of care (331). All patients were receiving optimal medical therapy.

The only significant difference in the use of ACE inhibitors between home monitoring and control groups (92% v. 86%, respectively), said Dr. Hindricks.

Patients were on average 65 years old and the majority was male. On average, 60% had an implanted CRT-D, and 40%, an ICD. Follow-up was 1 year.

The primary endpoint was the modified Packer Score, and 19% of the patients in the home monitoring group suffered from a worsening of their condition, compared with close to 28% in the group who were receiving the current standard of care only (P less than .05).

The secondary endpoint of all-cause mortality, also showed highly significant reduction in the home monitoring group (10 deaths), compared with the control arm (27 deaths) (P = .004). And, while 80% of all deaths were due to cardiovascular causes, there was a significant reduction in the cardiovascular mortality among the home monitoring group (8 deaths vs. 21 deaths in control; P = .012).

The home monitoring transmission rate was 85%, and there were 1,311 home monitoring observations, 66% of which were related to home monitoring issues; for instance, the patient’s device hadn’t transmitted data for 3 consecutive days, triggering an alert. The rest resulted from clinical events, with atrial fibrillation events being the most common (8.5%).

A total of 696 of patient contacts were made as a result of home monitoring alerts. Preliminary analysis of the data showed that 13% were from drug incompliance and 16% triggered additional visit to physician.

Dr. Hindricks said that one of the keys to the success of the program was minimal patient involvement.

Dr. Auricchio said that IN-TIME was a very important study "but we should have a cautionary note about the fact that the technology used is quite proprietary to one company, so the question is if it applies to other providers." He added that the study was done in a very defined patient population, and it’s yet to be seen whether its findings apply to other heart failure patients.

Dr. Hindricks has received honoraria for lectures and has been an adviser/consultant for Biosense, Biotronik, Stereotaxis, and St. Jude Medical. He has also been an adviser/consultant for CyberHeart. Dr. Auricchio has received payments from Biotronik, St. Jude Medical, Medtronic, Abbott, Philips, and several other companies.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

AMSTERDAM – An implant-based remote monitoring system in patients with advanced heart failure significantly reduced the worsening of their condition, overnight hospitalization, and total mortality, according to a trial conducted by the device-maker.

The IN-TIME study, a multicenter, prospective, randomized, controlled trial, showed that the mortality at 1 year follow-up was 3.4% in the home monitoring group, compared with 8.7% in patients with standard care. This is the first time a home monitoring trial has shown a significant drop in death rate.

"IN-TIME is really a timely study," said Dr. Angelo Auricchio of Lugano, Switzerland, because the study coincides with the most recent ESC guidelines for CRT and pacemakers, which for the very first time contain recommendation for remote monitoring. Dr. Auricchio was one of the guideline’s authors.

Rehospitalization or death resulting from worsening heart failure are often preceded by clinical events or specific trends in clinical parameters. Use of home monitoring can detect some of these events and trends early, "offering the possibility to intervene and prevent hospitalization for worsening heart failure," said Dr. Gerhard Hindricks, the lead investigator of the trial, who presented the results at the annual congress of the European Society of Cardiology.

Findings from other trials, including TRUST and REFORM have hinted at the benefits of remote monitoring, but they didn’t show the significant results seen with IN-TIME.

Patients received Biotronik’s ICD or CRT-D equipped with home monitoring software. The device detects biological signals, such as heart rate, occurrence of arrhythmias, onset of arrhythmia or shocks, and transmits the signals to a small external patient communicator called Cardio Messenger, which in turn sends the signals to a centralized monitoring unit in Heart Center Leipzig, Germany.

"Trained nursing staff took the incoming data, and then activated a chain of action according to prespecified workflows,\" said Dr. Hindricks of University of Leipzig. In some cases, if the physician was not available, the providers would directly contact the patient to advise a follow-up with a general practitioner or appropriate clinic. The physician would also enter the information about the measure taken into the centralized monitoring system.

Researchers randomized 664 patients – 1:1, with no crossover – to either home monitoring (333) or standard of care (331). All patients were receiving optimal medical therapy.

The only significant difference in the use of ACE inhibitors between home monitoring and control groups (92% v. 86%, respectively), said Dr. Hindricks.

Patients were on average 65 years old and the majority was male. On average, 60% had an implanted CRT-D, and 40%, an ICD. Follow-up was 1 year.

The primary endpoint was the modified Packer Score, and 19% of the patients in the home monitoring group suffered from a worsening of their condition, compared with close to 28% in the group who were receiving the current standard of care only (P less than .05).

The secondary endpoint of all-cause mortality, also showed highly significant reduction in the home monitoring group (10 deaths), compared with the control arm (27 deaths) (P = .004). And, while 80% of all deaths were due to cardiovascular causes, there was a significant reduction in the cardiovascular mortality among the home monitoring group (8 deaths vs. 21 deaths in control; P = .012).

The home monitoring transmission rate was 85%, and there were 1,311 home monitoring observations, 66% of which were related to home monitoring issues; for instance, the patient’s device hadn’t transmitted data for 3 consecutive days, triggering an alert. The rest resulted from clinical events, with atrial fibrillation events being the most common (8.5%).

A total of 696 of patient contacts were made as a result of home monitoring alerts. Preliminary analysis of the data showed that 13% were from drug incompliance and 16% triggered additional visit to physician.

Dr. Hindricks said that one of the keys to the success of the program was minimal patient involvement.

Dr. Auricchio said that IN-TIME was a very important study "but we should have a cautionary note about the fact that the technology used is quite proprietary to one company, so the question is if it applies to other providers." He added that the study was done in a very defined patient population, and it’s yet to be seen whether its findings apply to other heart failure patients.

Dr. Hindricks has received honoraria for lectures and has been an adviser/consultant for Biosense, Biotronik, Stereotaxis, and St. Jude Medical. He has also been an adviser/consultant for CyberHeart. Dr. Auricchio has received payments from Biotronik, St. Jude Medical, Medtronic, Abbott, Philips, and several other companies.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

AMSTERDAM – An implant-based remote monitoring system in patients with advanced heart failure significantly reduced the worsening of their condition, overnight hospitalization, and total mortality, according to a trial conducted by the device-maker.

The IN-TIME study, a multicenter, prospective, randomized, controlled trial, showed that the mortality at 1 year follow-up was 3.4% in the home monitoring group, compared with 8.7% in patients with standard care. This is the first time a home monitoring trial has shown a significant drop in death rate.

"IN-TIME is really a timely study," said Dr. Angelo Auricchio of Lugano, Switzerland, because the study coincides with the most recent ESC guidelines for CRT and pacemakers, which for the very first time contain recommendation for remote monitoring. Dr. Auricchio was one of the guideline’s authors.

Rehospitalization or death resulting from worsening heart failure are often preceded by clinical events or specific trends in clinical parameters. Use of home monitoring can detect some of these events and trends early, "offering the possibility to intervene and prevent hospitalization for worsening heart failure," said Dr. Gerhard Hindricks, the lead investigator of the trial, who presented the results at the annual congress of the European Society of Cardiology.

Findings from other trials, including TRUST and REFORM have hinted at the benefits of remote monitoring, but they didn’t show the significant results seen with IN-TIME.

Patients received Biotronik’s ICD or CRT-D equipped with home monitoring software. The device detects biological signals, such as heart rate, occurrence of arrhythmias, onset of arrhythmia or shocks, and transmits the signals to a small external patient communicator called Cardio Messenger, which in turn sends the signals to a centralized monitoring unit in Heart Center Leipzig, Germany.

"Trained nursing staff took the incoming data, and then activated a chain of action according to prespecified workflows,\" said Dr. Hindricks of University of Leipzig. In some cases, if the physician was not available, the providers would directly contact the patient to advise a follow-up with a general practitioner or appropriate clinic. The physician would also enter the information about the measure taken into the centralized monitoring system.

Researchers randomized 664 patients – 1:1, with no crossover – to either home monitoring (333) or standard of care (331). All patients were receiving optimal medical therapy.

The only significant difference in the use of ACE inhibitors between home monitoring and control groups (92% v. 86%, respectively), said Dr. Hindricks.

Patients were on average 65 years old and the majority was male. On average, 60% had an implanted CRT-D, and 40%, an ICD. Follow-up was 1 year.

The primary endpoint was the modified Packer Score, and 19% of the patients in the home monitoring group suffered from a worsening of their condition, compared with close to 28% in the group who were receiving the current standard of care only (P less than .05).

The secondary endpoint of all-cause mortality, also showed highly significant reduction in the home monitoring group (10 deaths), compared with the control arm (27 deaths) (P = .004). And, while 80% of all deaths were due to cardiovascular causes, there was a significant reduction in the cardiovascular mortality among the home monitoring group (8 deaths vs. 21 deaths in control; P = .012).

The home monitoring transmission rate was 85%, and there were 1,311 home monitoring observations, 66% of which were related to home monitoring issues; for instance, the patient’s device hadn’t transmitted data for 3 consecutive days, triggering an alert. The rest resulted from clinical events, with atrial fibrillation events being the most common (8.5%).

A total of 696 of patient contacts were made as a result of home monitoring alerts. Preliminary analysis of the data showed that 13% were from drug incompliance and 16% triggered additional visit to physician.

Dr. Hindricks said that one of the keys to the success of the program was minimal patient involvement.

Dr. Auricchio said that IN-TIME was a very important study "but we should have a cautionary note about the fact that the technology used is quite proprietary to one company, so the question is if it applies to other providers." He added that the study was done in a very defined patient population, and it’s yet to be seen whether its findings apply to other heart failure patients.

Dr. Hindricks has received honoraria for lectures and has been an adviser/consultant for Biosense, Biotronik, Stereotaxis, and St. Jude Medical. He has also been an adviser/consultant for CyberHeart. Dr. Auricchio has received payments from Biotronik, St. Jude Medical, Medtronic, Abbott, Philips, and several other companies.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

AMSTERDAM – Older men who continued to smoke in their 70s were 50% more likely to die from cancer, cardiovascular disease, and respiratory disease, compared with those who never smoked. They were also less likely to survive to age 85, according to findings from a British survey.

"The real message is that risk remains big for smokers at any age, and the evidence regarding benefits of quitting smoking persists even into old age," said Jonathan Emberson, Ph.D., a senior statistician at the University of Oxford (England), who presented the study at the annual congress of the European Society of Cardiology.

The results were from a prospective study of more than 7,000 surviving men who were initially recruited between 1967 and 1970 in the Whitehall study. The men were surveyed again in 1997-1998, when their mean age was 77 years. Follow-up information was obtained on cause-specific mortality through 2012.

At the resurvey in 1997-1998, 13% were current smokers and smoked a median of 9 cigarettes a day; 58% were former smokers, with median time of 25 years since quitting; and 23% said they never smoked. The remaining 5% said they were never-smokers in the resurvey, but not in the initial survey in 1967-1970, and were handled as a separate category, the researchers noted.

During the median follow-up of 15 years, there were 4,965 deaths, 2,063 of which resulted from cardiovascular disease, 1,167 from cancer, 802 from respiratory disease, and 933 from other causes.

Comparing the 984 smokers with 1,625 never-smokers showed that current smokers had a 50% increase in annual mortality. Their odds of death from vascular causes increased by nearly one-third, and from nonvascular causes by nearly two-thirds.

Meanwhile, a comparison between 4,091 ex-smokers and 1,625 never-smokers showed that ex-smokers had a 15% increase in annual mortality, mainly because of cancer (hazard ratio, 1.24) and respiratory disease (HR, 1.58).

Also, their risk varied considerably depending on the number of years since they had quit smoking. Men who had quit within the past 25 years had a 22% higher mortality than never-smokers, but men who had quit 25 or more years ago had no significant excess risk (HR, 1.05). Men who had quit smoking within the past 10 years had a 44% increase in all-cause mortality, compared with never-smokers. 

Also, current smokers had lower odds of surviving to age 85 (48%) than did never-smokers (65%), losing on average of 3-4 years of life expectancy.

Dr. Emberson said that never-smokers not only lived longer, but had a better quality of life. Nevertheless, "quitting remains beneficial at any age," he said.

Dr. Emberson had no disclosures. The study was funded by the U.K. Medical Research Council, the British Heart Foundation, and Cancer Research UK.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

AMSTERDAM – Older men who continued to smoke in their 70s were 50% more likely to die from cancer, cardiovascular disease, and respiratory disease, compared with those who never smoked. They were also less likely to survive to age 85, according to findings from a British survey.

"The real message is that risk remains big for smokers at any age, and the evidence regarding benefits of quitting smoking persists even into old age," said Jonathan Emberson, Ph.D., a senior statistician at the University of Oxford (England), who presented the study at the annual congress of the European Society of Cardiology.

The results were from a prospective study of more than 7,000 surviving men who were initially recruited between 1967 and 1970 in the Whitehall study. The men were surveyed again in 1997-1998, when their mean age was 77 years. Follow-up information was obtained on cause-specific mortality through 2012.

At the resurvey in 1997-1998, 13% were current smokers and smoked a median of 9 cigarettes a day; 58% were former smokers, with median time of 25 years since quitting; and 23% said they never smoked. The remaining 5% said they were never-smokers in the resurvey, but not in the initial survey in 1967-1970, and were handled as a separate category, the researchers noted.

During the median follow-up of 15 years, there were 4,965 deaths, 2,063 of which resulted from cardiovascular disease, 1,167 from cancer, 802 from respiratory disease, and 933 from other causes.

Comparing the 984 smokers with 1,625 never-smokers showed that current smokers had a 50% increase in annual mortality. Their odds of death from vascular causes increased by nearly one-third, and from nonvascular causes by nearly two-thirds.

Meanwhile, a comparison between 4,091 ex-smokers and 1,625 never-smokers showed that ex-smokers had a 15% increase in annual mortality, mainly because of cancer (hazard ratio, 1.24) and respiratory disease (HR, 1.58).

Also, their risk varied considerably depending on the number of years since they had quit smoking. Men who had quit within the past 25 years had a 22% higher mortality than never-smokers, but men who had quit 25 or more years ago had no significant excess risk (HR, 1.05). Men who had quit smoking within the past 10 years had a 44% increase in all-cause mortality, compared with never-smokers. 

Also, current smokers had lower odds of surviving to age 85 (48%) than did never-smokers (65%), losing on average of 3-4 years of life expectancy.

Dr. Emberson said that never-smokers not only lived longer, but had a better quality of life. Nevertheless, "quitting remains beneficial at any age," he said.

Dr. Emberson had no disclosures. The study was funded by the U.K. Medical Research Council, the British Heart Foundation, and Cancer Research UK.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

AMSTERDAM – Older men who continued to smoke in their 70s were 50% more likely to die from cancer, cardiovascular disease, and respiratory disease, compared with those who never smoked. They were also less likely to survive to age 85, according to findings from a British survey.

"The real message is that risk remains big for smokers at any age, and the evidence regarding benefits of quitting smoking persists even into old age," said Jonathan Emberson, Ph.D., a senior statistician at the University of Oxford (England), who presented the study at the annual congress of the European Society of Cardiology.

The results were from a prospective study of more than 7,000 surviving men who were initially recruited between 1967 and 1970 in the Whitehall study. The men were surveyed again in 1997-1998, when their mean age was 77 years. Follow-up information was obtained on cause-specific mortality through 2012.

At the resurvey in 1997-1998, 13% were current smokers and smoked a median of 9 cigarettes a day; 58% were former smokers, with median time of 25 years since quitting; and 23% said they never smoked. The remaining 5% said they were never-smokers in the resurvey, but not in the initial survey in 1967-1970, and were handled as a separate category, the researchers noted.

During the median follow-up of 15 years, there were 4,965 deaths, 2,063 of which resulted from cardiovascular disease, 1,167 from cancer, 802 from respiratory disease, and 933 from other causes.

Comparing the 984 smokers with 1,625 never-smokers showed that current smokers had a 50% increase in annual mortality. Their odds of death from vascular causes increased by nearly one-third, and from nonvascular causes by nearly two-thirds.

Meanwhile, a comparison between 4,091 ex-smokers and 1,625 never-smokers showed that ex-smokers had a 15% increase in annual mortality, mainly because of cancer (hazard ratio, 1.24) and respiratory disease (HR, 1.58).

Also, their risk varied considerably depending on the number of years since they had quit smoking. Men who had quit within the past 25 years had a 22% higher mortality than never-smokers, but men who had quit 25 or more years ago had no significant excess risk (HR, 1.05). Men who had quit smoking within the past 10 years had a 44% increase in all-cause mortality, compared with never-smokers. 

Also, current smokers had lower odds of surviving to age 85 (48%) than did never-smokers (65%), losing on average of 3-4 years of life expectancy.

Dr. Emberson said that never-smokers not only lived longer, but had a better quality of life. Nevertheless, "quitting remains beneficial at any age," he said.

Dr. Emberson had no disclosures. The study was funded by the U.K. Medical Research Council, the British Heart Foundation, and Cancer Research UK.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller