Heart Failure

SAN DIEGO — The more advanced the stage of chronic kidney disease, the greater the risk of developing heart failure and subsequent risk of death, results from a large analysis of Medicare patients showed.

“Even a modest degree of chronic kidney disease is a very strong predictor of having cardiovascular morbidity and mortality,” Dr. Charles A. Herzog said in an interview at the annual meeting of the American Society of Nephrology.

“Chronic kidney disease is something that primary care physicians can easily detect, because it's very easy to do a serum creatinine in an office setting,” said Dr. Herzog, director of the Minneapolis–based cardiovascular special studies center of the U.S. Renal Data System Coordinating Center.

He identified just over 1 million patients aged at least 66 years from the general Medicare database and followed them during 2006-2007. Patients with heart failure and end-stage renal disease at baseline were excluded from the analysis.

The researchers used a Cox proportional hazard model to assess the patients' risk of developing incident heart failure, adjusting for demographics, comorbidities, and stage of chronic kidney disease. They used the Kaplan-Meier method to estimate the age-adjusted survival of patients after the development of incident heart failure.

At baseline, 59% of the patients were women and 88% were white. Most (95.8%) had no chronic kidney disease, 0.4% had stage I-II disease, 1.4% had stage III-IV disease, and the remainder (2.4%) had an unknown stage of disease.

After 1 year, heart failure occurred in 5.3% of patients with no chronic kidney disease at baseline, 12.7% of those with stage I-II disease, 15% of those with stage III-IV disease, and 12.3% of those whose disease stage was unknown.

Independent predictors of heart failure were age 70-74 years (hazard ratio 1.30); age 75-79 years (HR 1.75); age 80-84 years (HR 2.42); and age 85 years and older (HR 3.82). Other independent predictors included black race (HR 1.21); stage I-II chronic kidney disease (HR 1.45); stage III-IV disease (HR 1.68), and unknown stage of chronic kidney disease (HR 1.27).

Dr. Herzog also found that the the following comorbid conditions predicted heart failure: anemia (HR 1.22), diabetes (HR 1.57), ischemic heart disease (HR 1.67), and dysrhythmia (HR 1.94).

Over the 1-year period, 83% of patients with no chronic kidney disease survived, compared with 77% of those with stage I-II disease, 75% of those with stage II-IV disease, and 67% of those whose disease stage was unknown.

Dr. Herzog acknowledged that a limitation of the study was its reliance on Medicare claims data.

Dr. Herzog is a consultant for Amgen Inc., a scientific adviser for CorMedix Inc., and a trustee of the Roche Foundation for Anemia Research.

'A modest degree of chronic kidney disease is a very strong predictor' of cardiovascular morbidity and mortality,

Source DR. HERZOG

SAN DIEGO — The more advanced the stage of chronic kidney disease, the greater the risk of developing heart failure and subsequent risk of death, results from a large analysis of Medicare patients showed.

“Even a modest degree of chronic kidney disease is a very strong predictor of having cardiovascular morbidity and mortality,” Dr. Charles A. Herzog said in an interview at the annual meeting of the American Society of Nephrology.

“Chronic kidney disease is something that primary care physicians can easily detect, because it's very easy to do a serum creatinine in an office setting,” said Dr. Herzog, director of the Minneapolis–based cardiovascular special studies center of the U.S. Renal Data System Coordinating Center.

He identified just over 1 million patients aged at least 66 years from the general Medicare database and followed them during 2006-2007. Patients with heart failure and end-stage renal disease at baseline were excluded from the analysis.

The researchers used a Cox proportional hazard model to assess the patients' risk of developing incident heart failure, adjusting for demographics, comorbidities, and stage of chronic kidney disease. They used the Kaplan-Meier method to estimate the age-adjusted survival of patients after the development of incident heart failure.

At baseline, 59% of the patients were women and 88% were white. Most (95.8%) had no chronic kidney disease, 0.4% had stage I-II disease, 1.4% had stage III-IV disease, and the remainder (2.4%) had an unknown stage of disease.

After 1 year, heart failure occurred in 5.3% of patients with no chronic kidney disease at baseline, 12.7% of those with stage I-II disease, 15% of those with stage III-IV disease, and 12.3% of those whose disease stage was unknown.

Independent predictors of heart failure were age 70-74 years (hazard ratio 1.30); age 75-79 years (HR 1.75); age 80-84 years (HR 2.42); and age 85 years and older (HR 3.82). Other independent predictors included black race (HR 1.21); stage I-II chronic kidney disease (HR 1.45); stage III-IV disease (HR 1.68), and unknown stage of chronic kidney disease (HR 1.27).

Dr. Herzog also found that the the following comorbid conditions predicted heart failure: anemia (HR 1.22), diabetes (HR 1.57), ischemic heart disease (HR 1.67), and dysrhythmia (HR 1.94).

Over the 1-year period, 83% of patients with no chronic kidney disease survived, compared with 77% of those with stage I-II disease, 75% of those with stage II-IV disease, and 67% of those whose disease stage was unknown.

Dr. Herzog acknowledged that a limitation of the study was its reliance on Medicare claims data.

Dr. Herzog is a consultant for Amgen Inc., a scientific adviser for CorMedix Inc., and a trustee of the Roche Foundation for Anemia Research.

'A modest degree of chronic kidney disease is a very strong predictor' of cardiovascular morbidity and mortality,

Source DR. HERZOG

SAN DIEGO — The more advanced the stage of chronic kidney disease, the greater the risk of developing heart failure and subsequent risk of death, results from a large analysis of Medicare patients showed.

“Even a modest degree of chronic kidney disease is a very strong predictor of having cardiovascular morbidity and mortality,” Dr. Charles A. Herzog said in an interview at the annual meeting of the American Society of Nephrology.

“Chronic kidney disease is something that primary care physicians can easily detect, because it's very easy to do a serum creatinine in an office setting,” said Dr. Herzog, director of the Minneapolis–based cardiovascular special studies center of the U.S. Renal Data System Coordinating Center.

He identified just over 1 million patients aged at least 66 years from the general Medicare database and followed them during 2006-2007. Patients with heart failure and end-stage renal disease at baseline were excluded from the analysis.

The researchers used a Cox proportional hazard model to assess the patients' risk of developing incident heart failure, adjusting for demographics, comorbidities, and stage of chronic kidney disease. They used the Kaplan-Meier method to estimate the age-adjusted survival of patients after the development of incident heart failure.

At baseline, 59% of the patients were women and 88% were white. Most (95.8%) had no chronic kidney disease, 0.4% had stage I-II disease, 1.4% had stage III-IV disease, and the remainder (2.4%) had an unknown stage of disease.

After 1 year, heart failure occurred in 5.3% of patients with no chronic kidney disease at baseline, 12.7% of those with stage I-II disease, 15% of those with stage III-IV disease, and 12.3% of those whose disease stage was unknown.

Independent predictors of heart failure were age 70-74 years (hazard ratio 1.30); age 75-79 years (HR 1.75); age 80-84 years (HR 2.42); and age 85 years and older (HR 3.82). Other independent predictors included black race (HR 1.21); stage I-II chronic kidney disease (HR 1.45); stage III-IV disease (HR 1.68), and unknown stage of chronic kidney disease (HR 1.27).

Dr. Herzog also found that the the following comorbid conditions predicted heart failure: anemia (HR 1.22), diabetes (HR 1.57), ischemic heart disease (HR 1.67), and dysrhythmia (HR 1.94).

Over the 1-year period, 83% of patients with no chronic kidney disease survived, compared with 77% of those with stage I-II disease, 75% of those with stage II-IV disease, and 67% of those whose disease stage was unknown.

Dr. Herzog acknowledged that a limitation of the study was its reliance on Medicare claims data.

Dr. Herzog is a consultant for Amgen Inc., a scientific adviser for CorMedix Inc., and a trustee of the Roche Foundation for Anemia Research.

'A modest degree of chronic kidney disease is a very strong predictor' of cardiovascular morbidity and mortality,

Source DR. HERZOG

Implantable cardioverter defibrillators do not reduce all-cause mortality in women who have advanced heart failure, unlike in men, according to a meta-analysis.

“ICDs are being implanted in hundreds of thousands of women without substantial evidence of benefit, apparently based on the assumption that, to paraphrase the old saying, 'What's good for the gander is good for the goose,'” Dr. Rita F. Redberg said in an accompanying editorial (Arch. Intern. Med. 2009;169:1460–1).

This finding is particularly concerning because a “recent analysis of the National Cardiovascular Data Registry found that women have a 70% higher risk of major adverse events after ICD implantation than do men,” noted Dr. Redberg, editor of the journal and director of women's cardiovascular services at the University of California, San Francisco.

Dr. Hamid Ghanbari and his associates at Providence Hospital in Southfield, Mich., pooled data from five randomized, controlled clinical trials that compared ICD implantation with medical therapy and included 934 women along with 3,810 men. Men who had heart failure with reduced left ventricular ejection fraction showed a significant decrease in all-cause mortality when they were given an ICD rather than medical therapy to prevent sudden cardiac death.

In contrast, women did not show a mortality benefit, either in the combined data or in any of the five individual trials, Dr. Ghanbari and his colleagues said (Arch. Intern. Med. 2009;169:1500–6).

Neither Dr. Ghanbari nor Dr. Redberg reported any financial conflicts of interest.

Implantable cardioverter defibrillators do not reduce all-cause mortality in women who have advanced heart failure, unlike in men, according to a meta-analysis.

“ICDs are being implanted in hundreds of thousands of women without substantial evidence of benefit, apparently based on the assumption that, to paraphrase the old saying, 'What's good for the gander is good for the goose,'” Dr. Rita F. Redberg said in an accompanying editorial (Arch. Intern. Med. 2009;169:1460–1).

This finding is particularly concerning because a “recent analysis of the National Cardiovascular Data Registry found that women have a 70% higher risk of major adverse events after ICD implantation than do men,” noted Dr. Redberg, editor of the journal and director of women's cardiovascular services at the University of California, San Francisco.

Dr. Hamid Ghanbari and his associates at Providence Hospital in Southfield, Mich., pooled data from five randomized, controlled clinical trials that compared ICD implantation with medical therapy and included 934 women along with 3,810 men. Men who had heart failure with reduced left ventricular ejection fraction showed a significant decrease in all-cause mortality when they were given an ICD rather than medical therapy to prevent sudden cardiac death.

In contrast, women did not show a mortality benefit, either in the combined data or in any of the five individual trials, Dr. Ghanbari and his colleagues said (Arch. Intern. Med. 2009;169:1500–6).

Neither Dr. Ghanbari nor Dr. Redberg reported any financial conflicts of interest.

Implantable cardioverter defibrillators do not reduce all-cause mortality in women who have advanced heart failure, unlike in men, according to a meta-analysis.

“ICDs are being implanted in hundreds of thousands of women without substantial evidence of benefit, apparently based on the assumption that, to paraphrase the old saying, 'What's good for the gander is good for the goose,'” Dr. Rita F. Redberg said in an accompanying editorial (Arch. Intern. Med. 2009;169:1460–1).

This finding is particularly concerning because a “recent analysis of the National Cardiovascular Data Registry found that women have a 70% higher risk of major adverse events after ICD implantation than do men,” noted Dr. Redberg, editor of the journal and director of women's cardiovascular services at the University of California, San Francisco.

Dr. Hamid Ghanbari and his associates at Providence Hospital in Southfield, Mich., pooled data from five randomized, controlled clinical trials that compared ICD implantation with medical therapy and included 934 women along with 3,810 men. Men who had heart failure with reduced left ventricular ejection fraction showed a significant decrease in all-cause mortality when they were given an ICD rather than medical therapy to prevent sudden cardiac death.

In contrast, women did not show a mortality benefit, either in the combined data or in any of the five individual trials, Dr. Ghanbari and his colleagues said (Arch. Intern. Med. 2009;169:1500–6).

Neither Dr. Ghanbari nor Dr. Redberg reported any financial conflicts of interest.

BOSTON — Performance improvement intervention for outpatient care of heart failure patients increases the use of evidence-based, guideline-recommended processes and therapies, Dr. Clyde W. Yancy said at the annual meeting of the Heart Failure Society of America.

Provision of prompts, pocket cards, check lists, and guideline-based decision-support algorithms significantly increases the likelihood that physicians will use evidence-based therapies, devices, and patient education, according to primary findings from the large-scale, prospective IMPROVE-HF (Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting) study.

To assess conformity with established heart failure (HF) performance measures based on class I recommendations of the national HF guidelines (Circulation 2005;112:e154–235), the IMPROVE-HF investigators reviewed the charts of 35,000 HF outpatients treated at the study's 167 sites at baseline, then 12 and 24 months after the implementation of the practice-specific process-of-care initiative, said Dr. Yancy of Baylor University Medical Center at Dallas.

The baseline findings suggested suboptimal conformity with performance measures for all of the practices considered, and significant variation in the use of evidence-based, guideline-recommended therapies, especially for women and the elderly. Large variations were observed in the use of anticoagulation for atrial fibrillation, implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy (CRT), and HF education. In all, only 27% of patients who were assessed with HF at baseline were receiving treatments for which they were eligible, based on the guidelines, Dr. Yancy reported.

But 24 months after the start of the initiative, significantly more patients received treatments for which they were eligible, across nearly all measures, Dr. Yancy said. The largest changes were observed in the use of ICDs, aldosterone receptor antagonists, and CRT, from 39%, 35%, and 50% of eligible patients, respectively, to 68%, 60%, and 56%. Use of ACE inhibitors or angiotensin receptor blockers and beta-blockers, and the provision of HF education, also improved significantly.

Dr. Yancy reported having no financial disclosures relative to his presentation. The IMPROVE-HF study is supported by Medtronic Inc.

After 24 months, significantly more patients received treatments for which they were eligible.

Source DR. YANCY

BOSTON — Performance improvement intervention for outpatient care of heart failure patients increases the use of evidence-based, guideline-recommended processes and therapies, Dr. Clyde W. Yancy said at the annual meeting of the Heart Failure Society of America.

Provision of prompts, pocket cards, check lists, and guideline-based decision-support algorithms significantly increases the likelihood that physicians will use evidence-based therapies, devices, and patient education, according to primary findings from the large-scale, prospective IMPROVE-HF (Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting) study.

To assess conformity with established heart failure (HF) performance measures based on class I recommendations of the national HF guidelines (Circulation 2005;112:e154–235), the IMPROVE-HF investigators reviewed the charts of 35,000 HF outpatients treated at the study's 167 sites at baseline, then 12 and 24 months after the implementation of the practice-specific process-of-care initiative, said Dr. Yancy of Baylor University Medical Center at Dallas.

The baseline findings suggested suboptimal conformity with performance measures for all of the practices considered, and significant variation in the use of evidence-based, guideline-recommended therapies, especially for women and the elderly. Large variations were observed in the use of anticoagulation for atrial fibrillation, implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy (CRT), and HF education. In all, only 27% of patients who were assessed with HF at baseline were receiving treatments for which they were eligible, based on the guidelines, Dr. Yancy reported.

But 24 months after the start of the initiative, significantly more patients received treatments for which they were eligible, across nearly all measures, Dr. Yancy said. The largest changes were observed in the use of ICDs, aldosterone receptor antagonists, and CRT, from 39%, 35%, and 50% of eligible patients, respectively, to 68%, 60%, and 56%. Use of ACE inhibitors or angiotensin receptor blockers and beta-blockers, and the provision of HF education, also improved significantly.

Dr. Yancy reported having no financial disclosures relative to his presentation. The IMPROVE-HF study is supported by Medtronic Inc.

After 24 months, significantly more patients received treatments for which they were eligible.

Source DR. YANCY

BOSTON — Performance improvement intervention for outpatient care of heart failure patients increases the use of evidence-based, guideline-recommended processes and therapies, Dr. Clyde W. Yancy said at the annual meeting of the Heart Failure Society of America.

Provision of prompts, pocket cards, check lists, and guideline-based decision-support algorithms significantly increases the likelihood that physicians will use evidence-based therapies, devices, and patient education, according to primary findings from the large-scale, prospective IMPROVE-HF (Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting) study.

To assess conformity with established heart failure (HF) performance measures based on class I recommendations of the national HF guidelines (Circulation 2005;112:e154–235), the IMPROVE-HF investigators reviewed the charts of 35,000 HF outpatients treated at the study's 167 sites at baseline, then 12 and 24 months after the implementation of the practice-specific process-of-care initiative, said Dr. Yancy of Baylor University Medical Center at Dallas.

The baseline findings suggested suboptimal conformity with performance measures for all of the practices considered, and significant variation in the use of evidence-based, guideline-recommended therapies, especially for women and the elderly. Large variations were observed in the use of anticoagulation for atrial fibrillation, implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy (CRT), and HF education. In all, only 27% of patients who were assessed with HF at baseline were receiving treatments for which they were eligible, based on the guidelines, Dr. Yancy reported.

But 24 months after the start of the initiative, significantly more patients received treatments for which they were eligible, across nearly all measures, Dr. Yancy said. The largest changes were observed in the use of ICDs, aldosterone receptor antagonists, and CRT, from 39%, 35%, and 50% of eligible patients, respectively, to 68%, 60%, and 56%. Use of ACE inhibitors or angiotensin receptor blockers and beta-blockers, and the provision of HF education, also improved significantly.

Dr. Yancy reported having no financial disclosures relative to his presentation. The IMPROVE-HF study is supported by Medtronic Inc.

After 24 months, significantly more patients received treatments for which they were eligible.

Source DR. YANCY

CHICAGO — Despite the underrepresentation of Hispanics in heart failure trials, evidence has emerged suggesting that they have unique risk factors and outcomes that must be taken into clinical consideration.

The evidence also underscores the need to recognize the vast heterogeneity of Hispanics, Dr. Ileana Piña said at a meeting sponsored by the International Society on Hypertension in Blacks.

“Hispanics represent a cultural group, not a racially identifiable group,” said the Cuban-born cardiologist. “You can't lump them all together.”

But that's exactly what has happened. It wasn't until the 2000 U.S. census that the term “Hispanic” was changed to “Spanish, Hispanic, or Latino” to describe persons of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race.

Several studies have made the observation—coined the “Hispanic paradox”—that Hispanics have lower all-cause and cardiovascular mortality, despite increased obesity and diabetes, and lower socioeconomic status, said Dr. Piña, professor of medicine at Case Western Reserve University, Cleveland.

A study of Medicare enrollees found that Hispanics were 1.2 times more likely to be hospitalized for heart failure than were whites, while blacks were 1.5 times more likely. But after adjustment for sex and age, in-hospital mortality was significantly lower in Hispanics and blacks than in whites. A California study also showed that blacks and “Latinos” initially hospitalized with heart failure in 1991 or 1992 were more likely to be rehospitalized than were Asians and whites, but were less likely to die during the following year.

Sociocultural factors are often used to explain the Hispanic paradox, but more recent data are causing some to rethink the paradox or at least to differentiate Hispanics by birthplace. Among diabetics in the San Antonio Heart Study, age- and sex-adjusted hazard ratios indicated that U.S.-born Mexican-Americans have a 66% greater risk of all-cause and CV mortality, compared with non-Hispanic whites, while Mexico-born Mexican-Americans appeared to be at similar risk.

Greater representation in patient registries, research studies, and clinical trials is needed Dr. Piña said. Only one major heart failure trial, HF-ACTION, has specifically differentiated Hispanics, and those patients made up just 3%.

Greater elucidation of heart failure risk factors and outcomes in Hispanic populations could lead to more targeted therapies and risk modification. With one in three U.S. residents expected to be Hispanic by 2050, there is great urgency to act, said Dr. Piña, who disclosed serving as a speaker for AstraZeneca, Novartis, and Merck.

CHICAGO — Despite the underrepresentation of Hispanics in heart failure trials, evidence has emerged suggesting that they have unique risk factors and outcomes that must be taken into clinical consideration.

The evidence also underscores the need to recognize the vast heterogeneity of Hispanics, Dr. Ileana Piña said at a meeting sponsored by the International Society on Hypertension in Blacks.

“Hispanics represent a cultural group, not a racially identifiable group,” said the Cuban-born cardiologist. “You can't lump them all together.”

But that's exactly what has happened. It wasn't until the 2000 U.S. census that the term “Hispanic” was changed to “Spanish, Hispanic, or Latino” to describe persons of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race.

Several studies have made the observation—coined the “Hispanic paradox”—that Hispanics have lower all-cause and cardiovascular mortality, despite increased obesity and diabetes, and lower socioeconomic status, said Dr. Piña, professor of medicine at Case Western Reserve University, Cleveland.

A study of Medicare enrollees found that Hispanics were 1.2 times more likely to be hospitalized for heart failure than were whites, while blacks were 1.5 times more likely. But after adjustment for sex and age, in-hospital mortality was significantly lower in Hispanics and blacks than in whites. A California study also showed that blacks and “Latinos” initially hospitalized with heart failure in 1991 or 1992 were more likely to be rehospitalized than were Asians and whites, but were less likely to die during the following year.

Sociocultural factors are often used to explain the Hispanic paradox, but more recent data are causing some to rethink the paradox or at least to differentiate Hispanics by birthplace. Among diabetics in the San Antonio Heart Study, age- and sex-adjusted hazard ratios indicated that U.S.-born Mexican-Americans have a 66% greater risk of all-cause and CV mortality, compared with non-Hispanic whites, while Mexico-born Mexican-Americans appeared to be at similar risk.

Greater representation in patient registries, research studies, and clinical trials is needed Dr. Piña said. Only one major heart failure trial, HF-ACTION, has specifically differentiated Hispanics, and those patients made up just 3%.

Greater elucidation of heart failure risk factors and outcomes in Hispanic populations could lead to more targeted therapies and risk modification. With one in three U.S. residents expected to be Hispanic by 2050, there is great urgency to act, said Dr. Piña, who disclosed serving as a speaker for AstraZeneca, Novartis, and Merck.

CHICAGO — Despite the underrepresentation of Hispanics in heart failure trials, evidence has emerged suggesting that they have unique risk factors and outcomes that must be taken into clinical consideration.

The evidence also underscores the need to recognize the vast heterogeneity of Hispanics, Dr. Ileana Piña said at a meeting sponsored by the International Society on Hypertension in Blacks.

“Hispanics represent a cultural group, not a racially identifiable group,” said the Cuban-born cardiologist. “You can't lump them all together.”

But that's exactly what has happened. It wasn't until the 2000 U.S. census that the term “Hispanic” was changed to “Spanish, Hispanic, or Latino” to describe persons of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race.

Several studies have made the observation—coined the “Hispanic paradox”—that Hispanics have lower all-cause and cardiovascular mortality, despite increased obesity and diabetes, and lower socioeconomic status, said Dr. Piña, professor of medicine at Case Western Reserve University, Cleveland.

A study of Medicare enrollees found that Hispanics were 1.2 times more likely to be hospitalized for heart failure than were whites, while blacks were 1.5 times more likely. But after adjustment for sex and age, in-hospital mortality was significantly lower in Hispanics and blacks than in whites. A California study also showed that blacks and “Latinos” initially hospitalized with heart failure in 1991 or 1992 were more likely to be rehospitalized than were Asians and whites, but were less likely to die during the following year.

Sociocultural factors are often used to explain the Hispanic paradox, but more recent data are causing some to rethink the paradox or at least to differentiate Hispanics by birthplace. Among diabetics in the San Antonio Heart Study, age- and sex-adjusted hazard ratios indicated that U.S.-born Mexican-Americans have a 66% greater risk of all-cause and CV mortality, compared with non-Hispanic whites, while Mexico-born Mexican-Americans appeared to be at similar risk.

Greater representation in patient registries, research studies, and clinical trials is needed Dr. Piña said. Only one major heart failure trial, HF-ACTION, has specifically differentiated Hispanics, and those patients made up just 3%.

Greater elucidation of heart failure risk factors and outcomes in Hispanic populations could lead to more targeted therapies and risk modification. With one in three U.S. residents expected to be Hispanic by 2050, there is great urgency to act, said Dr. Piña, who disclosed serving as a speaker for AstraZeneca, Novartis, and Merck.

BARCELONA — Erythropoietin therapy in patients with anemia of heart failure resulted in improved exercise capacity, reduced heart failure symptoms, and decreased hospitalizations, and showed strong trends for reduced rates of MI and all-cause mortality in a meta-analysis of 11 small randomized clinical trials.

Moreover, erythropoietin was not associated with an increased rate of adverse events, as in some clinical trials carried out in the settings of cancer or chronic kidney disease. It may be that erythropoietin's angiogenesis-promoting effect is therapeutic in the context of heart failure but is the source of side effects in patients with cancer or renal disease, Dr. Dipak Kotecha said at the annual congress of the European Society of Cardiology.

He was quick to offer a caveat, however: “This is all based on a relatively small sample size. Some of these trials were small proof-of-concept trials, others were mechanistic and looked at the effects of different doses. None were individually powered for clinical events. The follow-up was relatively short, at 2–12 months.”

The 11 randomized trials involved 794 patients with mild to moderate anemia and left ventricular systolic heart failure. Nine of the trials were placebo controlled. Mean baseline hemoglobin was 10.1–11.8 g/dL and rose by 2.0 g/dL in response to erythropoietin therapy.

This 2.0-g/dL increase in hemoglobin was associated with a mean 69-meter improvement in 6-minute walk distance compared with controls, a 96-second increase in exercise duration, and an improvement in New York Heart Association functional class equivalent to three-quarters of a class.

“All of these changes were clinically as well as statistically highly significant,” observed Dr. Kotecha of Royal Brompton Hospital, London.

Peak oxygen consumption, or VO₂ max, increased by an average of 2.3 mL/kg per min. Left ventricular ejection fraction increased in erythropoietin-treated patients by an absolute 5.8% compared with controls; that is comparable to the improvement seen in the major clinical trials of beta-blockers. Quality of life scores using the standard Minnesota and Kansas City instruments showed significant gains as well.

Heart failure hospitalizations in erythropoietin-treated patients were significantly reduced by 36% compared with controls, reflecting an absolute 8% rate difference. “The absolute 8% decrease in hospitalizations for heart failure is very similar to what's been seen in the major clinical trials of beta-blocker therapy in heart failure,” Dr. Kotecha said.

B-type natriuretic peptide levels fell by an average of 40%, or 237 pg/dL, in response to erythropoietin. Again, that is a magnitude of effect similar to what has been seen in clinical trials of combined beta-blocker and ACE inhibitor or angiotensin receptor blocker therapy, he continued.

The risk of all-cause mortality was reduced by 39% in the erythropoietin treatment group, a strong trend that just missed statistical significance. The 27% relative risk reduction in acute MI also was not quite significant. Definitive answers as to whether erythropoietin therapy has a beneficial effect on these key outcomes are anticipated from the ongoing Amgen-sponsored phase III Reduction of Events With Darbepoetin Alfa in Heart Failure (RED-HF) trial, which is randomizing more than 3,000 patients.

Anemia occurs in one-third to one-half of patients with heart failure and has been associated with a markedly worse prognosis. Dr. Kotecha cited as an example a Dutch meta-analysis involving more than 153,000 heart failure patients, 37% of whom were anemic. The mortality after a minimum of 6 months of follow-up was 30% in nonanemic patients and 47% among those with anemia (J. Am. Coll. Cardiol. 2008;52:818–27)

Dr. Kotecha reported having no financial conflicts of interest in connection with the meta-analysis, which was conducted using Cochrane Collaboration methodology and has been submitted to the Cochrane Review for possible publication.

Heart failure hospitalizations in erythropoietin-treated patients were significantly reduced by 36%.

Source DR. KOTECHA

BARCELONA — Erythropoietin therapy in patients with anemia of heart failure resulted in improved exercise capacity, reduced heart failure symptoms, and decreased hospitalizations, and showed strong trends for reduced rates of MI and all-cause mortality in a meta-analysis of 11 small randomized clinical trials.

Moreover, erythropoietin was not associated with an increased rate of adverse events, as in some clinical trials carried out in the settings of cancer or chronic kidney disease. It may be that erythropoietin's angiogenesis-promoting effect is therapeutic in the context of heart failure but is the source of side effects in patients with cancer or renal disease, Dr. Dipak Kotecha said at the annual congress of the European Society of Cardiology.

He was quick to offer a caveat, however: “This is all based on a relatively small sample size. Some of these trials were small proof-of-concept trials, others were mechanistic and looked at the effects of different doses. None were individually powered for clinical events. The follow-up was relatively short, at 2–12 months.”

The 11 randomized trials involved 794 patients with mild to moderate anemia and left ventricular systolic heart failure. Nine of the trials were placebo controlled. Mean baseline hemoglobin was 10.1–11.8 g/dL and rose by 2.0 g/dL in response to erythropoietin therapy.

This 2.0-g/dL increase in hemoglobin was associated with a mean 69-meter improvement in 6-minute walk distance compared with controls, a 96-second increase in exercise duration, and an improvement in New York Heart Association functional class equivalent to three-quarters of a class.

“All of these changes were clinically as well as statistically highly significant,” observed Dr. Kotecha of Royal Brompton Hospital, London.

Peak oxygen consumption, or VO₂ max, increased by an average of 2.3 mL/kg per min. Left ventricular ejection fraction increased in erythropoietin-treated patients by an absolute 5.8% compared with controls; that is comparable to the improvement seen in the major clinical trials of beta-blockers. Quality of life scores using the standard Minnesota and Kansas City instruments showed significant gains as well.

Heart failure hospitalizations in erythropoietin-treated patients were significantly reduced by 36% compared with controls, reflecting an absolute 8% rate difference. “The absolute 8% decrease in hospitalizations for heart failure is very similar to what's been seen in the major clinical trials of beta-blocker therapy in heart failure,” Dr. Kotecha said.

B-type natriuretic peptide levels fell by an average of 40%, or 237 pg/dL, in response to erythropoietin. Again, that is a magnitude of effect similar to what has been seen in clinical trials of combined beta-blocker and ACE inhibitor or angiotensin receptor blocker therapy, he continued.

The risk of all-cause mortality was reduced by 39% in the erythropoietin treatment group, a strong trend that just missed statistical significance. The 27% relative risk reduction in acute MI also was not quite significant. Definitive answers as to whether erythropoietin therapy has a beneficial effect on these key outcomes are anticipated from the ongoing Amgen-sponsored phase III Reduction of Events With Darbepoetin Alfa in Heart Failure (RED-HF) trial, which is randomizing more than 3,000 patients.

Anemia occurs in one-third to one-half of patients with heart failure and has been associated with a markedly worse prognosis. Dr. Kotecha cited as an example a Dutch meta-analysis involving more than 153,000 heart failure patients, 37% of whom were anemic. The mortality after a minimum of 6 months of follow-up was 30% in nonanemic patients and 47% among those with anemia (J. Am. Coll. Cardiol. 2008;52:818–27)

Dr. Kotecha reported having no financial conflicts of interest in connection with the meta-analysis, which was conducted using Cochrane Collaboration methodology and has been submitted to the Cochrane Review for possible publication.

Heart failure hospitalizations in erythropoietin-treated patients were significantly reduced by 36%.

Source DR. KOTECHA

BARCELONA — Erythropoietin therapy in patients with anemia of heart failure resulted in improved exercise capacity, reduced heart failure symptoms, and decreased hospitalizations, and showed strong trends for reduced rates of MI and all-cause mortality in a meta-analysis of 11 small randomized clinical trials.

Moreover, erythropoietin was not associated with an increased rate of adverse events, as in some clinical trials carried out in the settings of cancer or chronic kidney disease. It may be that erythropoietin's angiogenesis-promoting effect is therapeutic in the context of heart failure but is the source of side effects in patients with cancer or renal disease, Dr. Dipak Kotecha said at the annual congress of the European Society of Cardiology.

He was quick to offer a caveat, however: “This is all based on a relatively small sample size. Some of these trials were small proof-of-concept trials, others were mechanistic and looked at the effects of different doses. None were individually powered for clinical events. The follow-up was relatively short, at 2–12 months.”

The 11 randomized trials involved 794 patients with mild to moderate anemia and left ventricular systolic heart failure. Nine of the trials were placebo controlled. Mean baseline hemoglobin was 10.1–11.8 g/dL and rose by 2.0 g/dL in response to erythropoietin therapy.

This 2.0-g/dL increase in hemoglobin was associated with a mean 69-meter improvement in 6-minute walk distance compared with controls, a 96-second increase in exercise duration, and an improvement in New York Heart Association functional class equivalent to three-quarters of a class.

“All of these changes were clinically as well as statistically highly significant,” observed Dr. Kotecha of Royal Brompton Hospital, London.

Peak oxygen consumption, or VO₂ max, increased by an average of 2.3 mL/kg per min. Left ventricular ejection fraction increased in erythropoietin-treated patients by an absolute 5.8% compared with controls; that is comparable to the improvement seen in the major clinical trials of beta-blockers. Quality of life scores using the standard Minnesota and Kansas City instruments showed significant gains as well.

Heart failure hospitalizations in erythropoietin-treated patients were significantly reduced by 36% compared with controls, reflecting an absolute 8% rate difference. “The absolute 8% decrease in hospitalizations for heart failure is very similar to what's been seen in the major clinical trials of beta-blocker therapy in heart failure,” Dr. Kotecha said.

B-type natriuretic peptide levels fell by an average of 40%, or 237 pg/dL, in response to erythropoietin. Again, that is a magnitude of effect similar to what has been seen in clinical trials of combined beta-blocker and ACE inhibitor or angiotensin receptor blocker therapy, he continued.

The risk of all-cause mortality was reduced by 39% in the erythropoietin treatment group, a strong trend that just missed statistical significance. The 27% relative risk reduction in acute MI also was not quite significant. Definitive answers as to whether erythropoietin therapy has a beneficial effect on these key outcomes are anticipated from the ongoing Amgen-sponsored phase III Reduction of Events With Darbepoetin Alfa in Heart Failure (RED-HF) trial, which is randomizing more than 3,000 patients.

Anemia occurs in one-third to one-half of patients with heart failure and has been associated with a markedly worse prognosis. Dr. Kotecha cited as an example a Dutch meta-analysis involving more than 153,000 heart failure patients, 37% of whom were anemic. The mortality after a minimum of 6 months of follow-up was 30% in nonanemic patients and 47% among those with anemia (J. Am. Coll. Cardiol. 2008;52:818–27)

Dr. Kotecha reported having no financial conflicts of interest in connection with the meta-analysis, which was conducted using Cochrane Collaboration methodology and has been submitted to the Cochrane Review for possible publication.

Heart failure hospitalizations in erythropoietin-treated patients were significantly reduced by 36%.

Source DR. KOTECHA

BARCELONA — In its pivotal phase III clinical trial for treatment of patients in acute heart failure with renal impairment, the selective adenosine A1 receptor antagonist rolofylline has failed in every respect, and Merck has announced it will discontinue the drug's development.

Rolofylline had shown promise in an earlier 301-patient pilot study, with favorable effects on dyspnea and renal function and trends for lower mortality and readmission rates than with standard therapy, Dr. Marco Metra said at the annual congress of the European Society of Cardiology.

The negative findings in a definitive study for a drug with a novel mechanism of action are a setback in the effort to find new, more effective treatments for acute heart failure. AHF is the No. 1 cause of hospitalization in patients over age 65, it carries a dismal prognosis, and there have been no significant advances in its medical treatment, he said at a press conference in which he discussed the PROTECT trial.

Most patients who are hospitalized with AHF have underlying chronic kidney disease or experience worsening renal function during their hospital stay. This is associated with a worse prognosis. Adenosine mediates diuretic resistance and worsening renal function, so rolofylline, as a selective adenosine blocker, was an attractive drug, explained Dr. Metra of the University of Brescia (Italy).

In PROTECT, 2,033 patients were randomized 2:1 to 30 mg/day of intravenous rolofylline given over 4 hours for 3 days or placebo. All participants were hospitalized with signs of fluid overload requiring intravenous loop diuretics, mild to moderate impairment of renal function, and an elevated concentration of either brain natriuretic peptide or N-terminal pro-B-type natriuretic peptide.

The primary outcome was treatment success, defined as moderate to marked improvement in dyspnea 24 and 48 hours after the start of treatment in the absence of persistent renal impairment or other negative outcomes. This was achieved in 41% of the rolofylline group and 36% of controls, a nonsignificant difference.

The drug proved to have no impact on the roughly 15% rate of persistent renal failure, the 60-day readmission rate of just under 26%, or 60-day mortality, which was 8.9% with rolofylline and 9.5% with placebo.

Particularly concerning was the finding that seizures or stroke occurred in 1.5% of the rolofylline group, compared with 0.6% of the placebo group, said Dr. Metra, who has been a consultant and advisory board member for Merck.

Seizures or stroke occurred in 1.5% of the rolofylline group, compared with 0.6% of the placebo group.

Source Dr. metra

BARCELONA — In its pivotal phase III clinical trial for treatment of patients in acute heart failure with renal impairment, the selective adenosine A1 receptor antagonist rolofylline has failed in every respect, and Merck has announced it will discontinue the drug's development.

Rolofylline had shown promise in an earlier 301-patient pilot study, with favorable effects on dyspnea and renal function and trends for lower mortality and readmission rates than with standard therapy, Dr. Marco Metra said at the annual congress of the European Society of Cardiology.

The negative findings in a definitive study for a drug with a novel mechanism of action are a setback in the effort to find new, more effective treatments for acute heart failure. AHF is the No. 1 cause of hospitalization in patients over age 65, it carries a dismal prognosis, and there have been no significant advances in its medical treatment, he said at a press conference in which he discussed the PROTECT trial.

Most patients who are hospitalized with AHF have underlying chronic kidney disease or experience worsening renal function during their hospital stay. This is associated with a worse prognosis. Adenosine mediates diuretic resistance and worsening renal function, so rolofylline, as a selective adenosine blocker, was an attractive drug, explained Dr. Metra of the University of Brescia (Italy).

In PROTECT, 2,033 patients were randomized 2:1 to 30 mg/day of intravenous rolofylline given over 4 hours for 3 days or placebo. All participants were hospitalized with signs of fluid overload requiring intravenous loop diuretics, mild to moderate impairment of renal function, and an elevated concentration of either brain natriuretic peptide or N-terminal pro-B-type natriuretic peptide.

The primary outcome was treatment success, defined as moderate to marked improvement in dyspnea 24 and 48 hours after the start of treatment in the absence of persistent renal impairment or other negative outcomes. This was achieved in 41% of the rolofylline group and 36% of controls, a nonsignificant difference.

The drug proved to have no impact on the roughly 15% rate of persistent renal failure, the 60-day readmission rate of just under 26%, or 60-day mortality, which was 8.9% with rolofylline and 9.5% with placebo.

Particularly concerning was the finding that seizures or stroke occurred in 1.5% of the rolofylline group, compared with 0.6% of the placebo group, said Dr. Metra, who has been a consultant and advisory board member for Merck.

Seizures or stroke occurred in 1.5% of the rolofylline group, compared with 0.6% of the placebo group.

Source Dr. metra

BARCELONA — In its pivotal phase III clinical trial for treatment of patients in acute heart failure with renal impairment, the selective adenosine A1 receptor antagonist rolofylline has failed in every respect, and Merck has announced it will discontinue the drug's development.

Rolofylline had shown promise in an earlier 301-patient pilot study, with favorable effects on dyspnea and renal function and trends for lower mortality and readmission rates than with standard therapy, Dr. Marco Metra said at the annual congress of the European Society of Cardiology.

The negative findings in a definitive study for a drug with a novel mechanism of action are a setback in the effort to find new, more effective treatments for acute heart failure. AHF is the No. 1 cause of hospitalization in patients over age 65, it carries a dismal prognosis, and there have been no significant advances in its medical treatment, he said at a press conference in which he discussed the PROTECT trial.

Most patients who are hospitalized with AHF have underlying chronic kidney disease or experience worsening renal function during their hospital stay. This is associated with a worse prognosis. Adenosine mediates diuretic resistance and worsening renal function, so rolofylline, as a selective adenosine blocker, was an attractive drug, explained Dr. Metra of the University of Brescia (Italy).

In PROTECT, 2,033 patients were randomized 2:1 to 30 mg/day of intravenous rolofylline given over 4 hours for 3 days or placebo. All participants were hospitalized with signs of fluid overload requiring intravenous loop diuretics, mild to moderate impairment of renal function, and an elevated concentration of either brain natriuretic peptide or N-terminal pro-B-type natriuretic peptide.

The primary outcome was treatment success, defined as moderate to marked improvement in dyspnea 24 and 48 hours after the start of treatment in the absence of persistent renal impairment or other negative outcomes. This was achieved in 41% of the rolofylline group and 36% of controls, a nonsignificant difference.

The drug proved to have no impact on the roughly 15% rate of persistent renal failure, the 60-day readmission rate of just under 26%, or 60-day mortality, which was 8.9% with rolofylline and 9.5% with placebo.

Particularly concerning was the finding that seizures or stroke occurred in 1.5% of the rolofylline group, compared with 0.6% of the placebo group, said Dr. Metra, who has been a consultant and advisory board member for Merck.

Seizures or stroke occurred in 1.5% of the rolofylline group, compared with 0.6% of the placebo group.

Source Dr. metra

BARCELONA — The common practice of discontinuing beta-blocker therapy during hospitalization for acute heart failure is counterproductive, according to a French randomized trial.

“During acute heart failure, beta-blocker therapy should be continued, because this practice is not associated with delayed or lesser improvement, and there is a higher rate of chronic beta-blocker therapy 3 months later, the benefits of which are well established,” Dr. Guillaume Jondeau concluded in presenting the results of the Beta Blocker Continuation Versus Interruption in Patients With Congestive Heart Failure Hospitalized for a Decompensation Episode (B-CONVINCED) trial at the annual congress of the European Society of Cardiology.

B-CONVINCED was conducted to redress the lack of level 1 evidence regarding the best clinical strategy when patients with systolic dysfunction who are on chronic beta-blocker therapy are hospitalized for acute heart failure (AHF). Many physicians, reasoning that the failing circulatory system needs adrenergic support, halve the dose or halt the drug altogether. The 2008 ESC guidelines state as a class IIA recommendation that “a reduction in the beta-blocker dose may be necessary. In severe situations, temporary discontinuation can be considered.”

B-CONVINCED, a noninferiority trial in 147 patients, hypothesized that continuing the beta-blocker would not result in worse outcomes than stoppage upon hospital admission. The primary end point was improvement in both dyspnea and general well being as assessed by blinded physicians 3 days into the hospitalization. This was achieved in 93% of the beta-blocker continuation group and 92% of the drug-halt group. Similarly, another round of blinded physician assessments after 8 days concluded 95% of patients in both study arms were significantly improved. Duration of hospital stay, patient self-assessments, and rehospitalization rates during the next 3 months were also similar in the two groups.

However, the proportion of patients on beta-blocker therapy 3 months after the acute exacerbation was significantly different: 90% in the continuation group and 76% in the discontinuation group. This reflects the reality that once beta-blocker therapy for AHF has been stopped, it can be a challenge to restart and titrate up to effective doses, said Dr. Jondeau of the University of Paris.

Discussant Karl Swedberg noted that there is a decades-long history of skepticism regarding the use of beta-blockers in heart failure. Yet today, they are the best-documented and most effective therapy for systolic heart failure.

B-CONVINCED provides the first solid randomized clinical trial evidence that sticking to the prehospitalization dose of a beta-blocker during an AHF exacerbation instead of halting the drug at admission should be the first-line strategy, said Dr. Swedberg, professor of cardiology at Sahlgrenska University Hospital, Goteborg, Sweden. “More patients will be on effective treatment at 3 months, and many lives will be saved by this strategy.”

The trial was funded by the French Ministry of Health. Neither Dr. Jondeau nor Dr. Swedberg disclosed any relationships with industry.

BARCELONA — The common practice of discontinuing beta-blocker therapy during hospitalization for acute heart failure is counterproductive, according to a French randomized trial.

“During acute heart failure, beta-blocker therapy should be continued, because this practice is not associated with delayed or lesser improvement, and there is a higher rate of chronic beta-blocker therapy 3 months later, the benefits of which are well established,” Dr. Guillaume Jondeau concluded in presenting the results of the Beta Blocker Continuation Versus Interruption in Patients With Congestive Heart Failure Hospitalized for a Decompensation Episode (B-CONVINCED) trial at the annual congress of the European Society of Cardiology.

B-CONVINCED was conducted to redress the lack of level 1 evidence regarding the best clinical strategy when patients with systolic dysfunction who are on chronic beta-blocker therapy are hospitalized for acute heart failure (AHF). Many physicians, reasoning that the failing circulatory system needs adrenergic support, halve the dose or halt the drug altogether. The 2008 ESC guidelines state as a class IIA recommendation that “a reduction in the beta-blocker dose may be necessary. In severe situations, temporary discontinuation can be considered.”

B-CONVINCED, a noninferiority trial in 147 patients, hypothesized that continuing the beta-blocker would not result in worse outcomes than stoppage upon hospital admission. The primary end point was improvement in both dyspnea and general well being as assessed by blinded physicians 3 days into the hospitalization. This was achieved in 93% of the beta-blocker continuation group and 92% of the drug-halt group. Similarly, another round of blinded physician assessments after 8 days concluded 95% of patients in both study arms were significantly improved. Duration of hospital stay, patient self-assessments, and rehospitalization rates during the next 3 months were also similar in the two groups.

However, the proportion of patients on beta-blocker therapy 3 months after the acute exacerbation was significantly different: 90% in the continuation group and 76% in the discontinuation group. This reflects the reality that once beta-blocker therapy for AHF has been stopped, it can be a challenge to restart and titrate up to effective doses, said Dr. Jondeau of the University of Paris.

Discussant Karl Swedberg noted that there is a decades-long history of skepticism regarding the use of beta-blockers in heart failure. Yet today, they are the best-documented and most effective therapy for systolic heart failure.

B-CONVINCED provides the first solid randomized clinical trial evidence that sticking to the prehospitalization dose of a beta-blocker during an AHF exacerbation instead of halting the drug at admission should be the first-line strategy, said Dr. Swedberg, professor of cardiology at Sahlgrenska University Hospital, Goteborg, Sweden. “More patients will be on effective treatment at 3 months, and many lives will be saved by this strategy.”

The trial was funded by the French Ministry of Health. Neither Dr. Jondeau nor Dr. Swedberg disclosed any relationships with industry.

BARCELONA — The common practice of discontinuing beta-blocker therapy during hospitalization for acute heart failure is counterproductive, according to a French randomized trial.

“During acute heart failure, beta-blocker therapy should be continued, because this practice is not associated with delayed or lesser improvement, and there is a higher rate of chronic beta-blocker therapy 3 months later, the benefits of which are well established,” Dr. Guillaume Jondeau concluded in presenting the results of the Beta Blocker Continuation Versus Interruption in Patients With Congestive Heart Failure Hospitalized for a Decompensation Episode (B-CONVINCED) trial at the annual congress of the European Society of Cardiology.

B-CONVINCED was conducted to redress the lack of level 1 evidence regarding the best clinical strategy when patients with systolic dysfunction who are on chronic beta-blocker therapy are hospitalized for acute heart failure (AHF). Many physicians, reasoning that the failing circulatory system needs adrenergic support, halve the dose or halt the drug altogether. The 2008 ESC guidelines state as a class IIA recommendation that “a reduction in the beta-blocker dose may be necessary. In severe situations, temporary discontinuation can be considered.”

B-CONVINCED, a noninferiority trial in 147 patients, hypothesized that continuing the beta-blocker would not result in worse outcomes than stoppage upon hospital admission. The primary end point was improvement in both dyspnea and general well being as assessed by blinded physicians 3 days into the hospitalization. This was achieved in 93% of the beta-blocker continuation group and 92% of the drug-halt group. Similarly, another round of blinded physician assessments after 8 days concluded 95% of patients in both study arms were significantly improved. Duration of hospital stay, patient self-assessments, and rehospitalization rates during the next 3 months were also similar in the two groups.

However, the proportion of patients on beta-blocker therapy 3 months after the acute exacerbation was significantly different: 90% in the continuation group and 76% in the discontinuation group. This reflects the reality that once beta-blocker therapy for AHF has been stopped, it can be a challenge to restart and titrate up to effective doses, said Dr. Jondeau of the University of Paris.

Discussant Karl Swedberg noted that there is a decades-long history of skepticism regarding the use of beta-blockers in heart failure. Yet today, they are the best-documented and most effective therapy for systolic heart failure.

B-CONVINCED provides the first solid randomized clinical trial evidence that sticking to the prehospitalization dose of a beta-blocker during an AHF exacerbation instead of halting the drug at admission should be the first-line strategy, said Dr. Swedberg, professor of cardiology at Sahlgrenska University Hospital, Goteborg, Sweden. “More patients will be on effective treatment at 3 months, and many lives will be saved by this strategy.”

The trial was funded by the French Ministry of Health. Neither Dr. Jondeau nor Dr. Swedberg disclosed any relationships with industry.

BOSTON — Monitoring fluid buildup in the chest by intrathoracic impedance is more predictive of events in heart failure patients than is daily weight monitoring, a multicenter, prospective, double-blind investigation has found.

Dr. William T. Abraham of Ohio State University, Columbus, and colleagues conducted the Fluid Accumulation Status Trial (FAST), comparing results of intrathoracic impedance monitoring with those of daily weight monitoring—the current standard of care—in 156 heart failure (HF) patients. The investigators used a drop in intrathoracic impedance as a surrogate to identify presymptomatic, treatable fluid buildup. Impedance changes were detected with software downloaded onto the patients' implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) devices.

All participants had HF symptoms for a mean of 18 months. At baseline, 85% were in New York Heart Association (NYHA) class II or III and most of the rest were in NYHA class I, Dr. Abraham reported in a late-breaking abstract presented at the annual meeting of the Heart Failure Society of America.

The investigators compared data collected by the impedance monitoring software and the patient-completed daily weight diaries. Impedance data were available nearly every day of the trial, but only 76% of the patients complied with daily weight monitoring, said Dr. Abraham.

Of the 65 HF events that occurred in 31 patients, intrathoracic impedance monitoring accurately predicted 48 of them; daily weight monitoring predicted 13. “The adjusted sensitivity for [impedance monitoring] was more than three times higher than with daily weight monitoring,” at 76% and 23%, respectively, he reported. Of the predicted events, 40 of those detected by impedance monitoring were not detected by weight monitoring and 5 of those detected by weight monitoring were not detected by fluid monitoring, Dr. Abraham said.

Both impedance and weight monitoring set off many false alarms. The impedance monitoring system identified 417 “impedance crossings,” which are the signals predicting an HF event, while there were 890 changes in weight that met the warning level criteria (at least three pounds gained in 1 day or at least five pounds gained over 3 days), Dr. Abraham said.

“With daily weight [monitoring], you have less sensitivity and more false alarms to respond to [compared with impedance monitoring],” suggesting that impedance status monitoring may be the better option and should be used in addition to the daily weight monitoring in patients with implanted devices that have this capability, he said.

The findings should not be considered in a vacuum, said Dr. Lynne Warner Stevenson of Brigham and Women's Hospital, Boston. “It's crucial that 88% of impedance crossings in this study were not associated with a following event. Responding to these could worsen renal function and lead to electrolyte derangements.”

Frequent such nonevents could blunt the system's responsiveness, she added. “If you keep seeing things go up, and nothing is happening, it would be like crying 'wolf.' It will be difficult to decide when we actually do need to intervene.”

FAST was sponsored by Medtronic Inc., maker of the OptiVol Fluid Status Monitoring System used in the study. Dr. Abraham has received research grants and/or consulting fees from Medtronic, Biotronik Inc., Boston Scientific Corp., and St. Jude Medical Inc. Dr. Stevenson has received funding and/or consulting fees from CardioMEMS Inc. and Medtronic.

BOSTON — Monitoring fluid buildup in the chest by intrathoracic impedance is more predictive of events in heart failure patients than is daily weight monitoring, a multicenter, prospective, double-blind investigation has found.

Dr. William T. Abraham of Ohio State University, Columbus, and colleagues conducted the Fluid Accumulation Status Trial (FAST), comparing results of intrathoracic impedance monitoring with those of daily weight monitoring—the current standard of care—in 156 heart failure (HF) patients. The investigators used a drop in intrathoracic impedance as a surrogate to identify presymptomatic, treatable fluid buildup. Impedance changes were detected with software downloaded onto the patients' implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) devices.

All participants had HF symptoms for a mean of 18 months. At baseline, 85% were in New York Heart Association (NYHA) class II or III and most of the rest were in NYHA class I, Dr. Abraham reported in a late-breaking abstract presented at the annual meeting of the Heart Failure Society of America.

The investigators compared data collected by the impedance monitoring software and the patient-completed daily weight diaries. Impedance data were available nearly every day of the trial, but only 76% of the patients complied with daily weight monitoring, said Dr. Abraham.

Of the 65 HF events that occurred in 31 patients, intrathoracic impedance monitoring accurately predicted 48 of them; daily weight monitoring predicted 13. “The adjusted sensitivity for [impedance monitoring] was more than three times higher than with daily weight monitoring,” at 76% and 23%, respectively, he reported. Of the predicted events, 40 of those detected by impedance monitoring were not detected by weight monitoring and 5 of those detected by weight monitoring were not detected by fluid monitoring, Dr. Abraham said.

Both impedance and weight monitoring set off many false alarms. The impedance monitoring system identified 417 “impedance crossings,” which are the signals predicting an HF event, while there were 890 changes in weight that met the warning level criteria (at least three pounds gained in 1 day or at least five pounds gained over 3 days), Dr. Abraham said.

“With daily weight [monitoring], you have less sensitivity and more false alarms to respond to [compared with impedance monitoring],” suggesting that impedance status monitoring may be the better option and should be used in addition to the daily weight monitoring in patients with implanted devices that have this capability, he said.

The findings should not be considered in a vacuum, said Dr. Lynne Warner Stevenson of Brigham and Women's Hospital, Boston. “It's crucial that 88% of impedance crossings in this study were not associated with a following event. Responding to these could worsen renal function and lead to electrolyte derangements.”

Frequent such nonevents could blunt the system's responsiveness, she added. “If you keep seeing things go up, and nothing is happening, it would be like crying 'wolf.' It will be difficult to decide when we actually do need to intervene.”

FAST was sponsored by Medtronic Inc., maker of the OptiVol Fluid Status Monitoring System used in the study. Dr. Abraham has received research grants and/or consulting fees from Medtronic, Biotronik Inc., Boston Scientific Corp., and St. Jude Medical Inc. Dr. Stevenson has received funding and/or consulting fees from CardioMEMS Inc. and Medtronic.

BOSTON — Monitoring fluid buildup in the chest by intrathoracic impedance is more predictive of events in heart failure patients than is daily weight monitoring, a multicenter, prospective, double-blind investigation has found.

Dr. William T. Abraham of Ohio State University, Columbus, and colleagues conducted the Fluid Accumulation Status Trial (FAST), comparing results of intrathoracic impedance monitoring with those of daily weight monitoring—the current standard of care—in 156 heart failure (HF) patients. The investigators used a drop in intrathoracic impedance as a surrogate to identify presymptomatic, treatable fluid buildup. Impedance changes were detected with software downloaded onto the patients' implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) devices.

All participants had HF symptoms for a mean of 18 months. At baseline, 85% were in New York Heart Association (NYHA) class II or III and most of the rest were in NYHA class I, Dr. Abraham reported in a late-breaking abstract presented at the annual meeting of the Heart Failure Society of America.

The investigators compared data collected by the impedance monitoring software and the patient-completed daily weight diaries. Impedance data were available nearly every day of the trial, but only 76% of the patients complied with daily weight monitoring, said Dr. Abraham.

Of the 65 HF events that occurred in 31 patients, intrathoracic impedance monitoring accurately predicted 48 of them; daily weight monitoring predicted 13. “The adjusted sensitivity for [impedance monitoring] was more than three times higher than with daily weight monitoring,” at 76% and 23%, respectively, he reported. Of the predicted events, 40 of those detected by impedance monitoring were not detected by weight monitoring and 5 of those detected by weight monitoring were not detected by fluid monitoring, Dr. Abraham said.

Both impedance and weight monitoring set off many false alarms. The impedance monitoring system identified 417 “impedance crossings,” which are the signals predicting an HF event, while there were 890 changes in weight that met the warning level criteria (at least three pounds gained in 1 day or at least five pounds gained over 3 days), Dr. Abraham said.

“With daily weight [monitoring], you have less sensitivity and more false alarms to respond to [compared with impedance monitoring],” suggesting that impedance status monitoring may be the better option and should be used in addition to the daily weight monitoring in patients with implanted devices that have this capability, he said.

The findings should not be considered in a vacuum, said Dr. Lynne Warner Stevenson of Brigham and Women's Hospital, Boston. “It's crucial that 88% of impedance crossings in this study were not associated with a following event. Responding to these could worsen renal function and lead to electrolyte derangements.”

Frequent such nonevents could blunt the system's responsiveness, she added. “If you keep seeing things go up, and nothing is happening, it would be like crying 'wolf.' It will be difficult to decide when we actually do need to intervene.”

FAST was sponsored by Medtronic Inc., maker of the OptiVol Fluid Status Monitoring System used in the study. Dr. Abraham has received research grants and/or consulting fees from Medtronic, Biotronik Inc., Boston Scientific Corp., and St. Jude Medical Inc. Dr. Stevenson has received funding and/or consulting fees from CardioMEMS Inc. and Medtronic.

NEW ORLEANS — A simple predictive instrument may improve emergency department disposition decisions regarding asymptomatic elderly patients who present with syncope.

The Syncope Risk Score defines a 10-fold gradient in the risk of delayed cardiac events among elderly ED patients with syncope, Dr. Benjamin Sun said at the annual meeting of the Society for Academic Emergency Medicine.

Patients whose score puts them in the low- or intermediate-risk categories may be reasonable candidates for discharge or a rapid ED observation unit. In contrast, those whose Syncope Risk Score places them in the high-risk group, with a 20% risk of a cardiac event during the next 30 days, probably should be admitted to the hospital, according to Dr. Sun of the University of California, Los Angeles.

The score relies upon one negative and six positive risk factors. All seven elements are readily obtainable in the first hour of an ED evaluation. A patient is assigned 1 point for each of the six factors conferring increased risk of delayed cardiac events, and minus 1 point for near syncope (see charts). The points are added up. A total score of 3-6 signifies high risk, 1-2 is intermediate, and 0 or −1 indicates low risk.

Dr. Sun developed the Syncope Risk Score through a retrospective cohort study of 2,871 asymptomatic geriatric patients, mean age 77 years, who visited any of three Southern California Kaiser Permanente EDs because of syncope and who did not have a serious underlying condition identified during their ED evaluation.

During the next 30 days, 170 patients experienced acute myocardial infarction, arrhythmia, coronary revascularization, or another delayed cardiac event. The seven independent predictors of these adverse outcomes that make up the Syncope Risk Score were derived via a multivariate logistic regression analysis that included more than 50 variables extracted from patients' medical charts.

The Syncope Risk Score is an attractively simple, quick tool, but before it is ready for prime-time clinical use in EDs it must be validated in an independent prospective study, Dr. Sun noted.

His development of the score was supported by the National Institutes of Health and the American Geriatrics Society.

Source ELSEVIER GLOBAL MEDICAL NEWS

Source ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — A simple predictive instrument may improve emergency department disposition decisions regarding asymptomatic elderly patients who present with syncope.

The Syncope Risk Score defines a 10-fold gradient in the risk of delayed cardiac events among elderly ED patients with syncope, Dr. Benjamin Sun said at the annual meeting of the Society for Academic Emergency Medicine.

Patients whose score puts them in the low- or intermediate-risk categories may be reasonable candidates for discharge or a rapid ED observation unit. In contrast, those whose Syncope Risk Score places them in the high-risk group, with a 20% risk of a cardiac event during the next 30 days, probably should be admitted to the hospital, according to Dr. Sun of the University of California, Los Angeles.

The score relies upon one negative and six positive risk factors. All seven elements are readily obtainable in the first hour of an ED evaluation. A patient is assigned 1 point for each of the six factors conferring increased risk of delayed cardiac events, and minus 1 point for near syncope (see charts). The points are added up. A total score of 3-6 signifies high risk, 1-2 is intermediate, and 0 or −1 indicates low risk.

Dr. Sun developed the Syncope Risk Score through a retrospective cohort study of 2,871 asymptomatic geriatric patients, mean age 77 years, who visited any of three Southern California Kaiser Permanente EDs because of syncope and who did not have a serious underlying condition identified during their ED evaluation.

During the next 30 days, 170 patients experienced acute myocardial infarction, arrhythmia, coronary revascularization, or another delayed cardiac event. The seven independent predictors of these adverse outcomes that make up the Syncope Risk Score were derived via a multivariate logistic regression analysis that included more than 50 variables extracted from patients' medical charts.

The Syncope Risk Score is an attractively simple, quick tool, but before it is ready for prime-time clinical use in EDs it must be validated in an independent prospective study, Dr. Sun noted.

His development of the score was supported by the National Institutes of Health and the American Geriatrics Society.

Source ELSEVIER GLOBAL MEDICAL NEWS

Source ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — A simple predictive instrument may improve emergency department disposition decisions regarding asymptomatic elderly patients who present with syncope.

The Syncope Risk Score defines a 10-fold gradient in the risk of delayed cardiac events among elderly ED patients with syncope, Dr. Benjamin Sun said at the annual meeting of the Society for Academic Emergency Medicine.

Patients whose score puts them in the low- or intermediate-risk categories may be reasonable candidates for discharge or a rapid ED observation unit. In contrast, those whose Syncope Risk Score places them in the high-risk group, with a 20% risk of a cardiac event during the next 30 days, probably should be admitted to the hospital, according to Dr. Sun of the University of California, Los Angeles.

The score relies upon one negative and six positive risk factors. All seven elements are readily obtainable in the first hour of an ED evaluation. A patient is assigned 1 point for each of the six factors conferring increased risk of delayed cardiac events, and minus 1 point for near syncope (see charts). The points are added up. A total score of 3-6 signifies high risk, 1-2 is intermediate, and 0 or −1 indicates low risk.

Dr. Sun developed the Syncope Risk Score through a retrospective cohort study of 2,871 asymptomatic geriatric patients, mean age 77 years, who visited any of three Southern California Kaiser Permanente EDs because of syncope and who did not have a serious underlying condition identified during their ED evaluation.

During the next 30 days, 170 patients experienced acute myocardial infarction, arrhythmia, coronary revascularization, or another delayed cardiac event. The seven independent predictors of these adverse outcomes that make up the Syncope Risk Score were derived via a multivariate logistic regression analysis that included more than 50 variables extracted from patients' medical charts.

The Syncope Risk Score is an attractively simple, quick tool, but before it is ready for prime-time clinical use in EDs it must be validated in an independent prospective study, Dr. Sun noted.

His development of the score was supported by the National Institutes of Health and the American Geriatrics Society.

Source ELSEVIER GLOBAL MEDICAL NEWS

Source ELSEVIER GLOBAL MEDICAL NEWS

SAN DIEGO — Combining an electrocardiogram with serum N-terminal pro-B-type natriuretic peptide measurements is a simple, noninvasive way to diagnose pulmonary hypertension, results from an Austrian study suggest.

“Current pulmonary hypertension diagnosis guidelines say that ECG alone is not useful in the diagnosis of pulmonary hypertension. This is true,” Dr. Diana Bonderman said in an interview during a poster session at an international conference of the American Thoracic Society. “But if you combine ECG with NT-proBNP [N-terminal pro-B-type natriuretic peptide], it's going to be useful.”

The finding is important, she said, because the growing awareness of pulmonary hypertension PH, a high prevalence of postcapillary PH, and the inability to discern between pre- and postcapillary PH by transthoracic echocardiography (TTE) “have led to unnecessary right heart catheterizations.”

She and her associates prospectively analyzed data from 121 patients referred to the Medical University of Vienna between April 2007 and October 2008 for clinical and transthoracic echocardiographic suspicion of precapillary pulmonary hypertension (defined as having a systolic pulmonary artery pressure of at least 36 mm Hg). On admission, all patients underwent TTE, serum analysis including NT-proBNP, a 6-minute walk test, and blood gas analysis.

The patients were then assigned to one of two predicted diagnostic groups: precapillary PH (defined as right ventricular strain on ECG and/or serum NT-proBNP of greater than 80 pg/mL) or no precapillary PH (defined as no right ventricular strain on ECG and NT-proBNP of 80 pg/mL or less). Next, all patients underwent invasive hemodynamic measurements by right heart catheterization, and a final diagnosis was established.

The mean age of the patients was 62 years and 59% were female, reported Dr. Bonderman, a cardiologist at the Medical University of Vienna.

By right heart catheterization, 64 (53%) patients were diagnosed with precapillary PH. Precapillary PH was ruled out in 57 (47%) patients. By the diagnostic algorithm, 15 patients (12%) had been correctly allocated to the group without precapillary PH (true negatives). None of the allocations was a false negative.

“In the diagnostic pathway of PH, integration of the proposed algorithm subsequent to TTE may increase specificity from 0% to 19.3%, with a sensitivity of 100%,” the researchers wrote. “The incorporation of ECG and NT-proBNP into the workup of PH provides incremental diagnostic value and may significantly reduce the number of invasive assessments.”

The researchers had no conflicts to disclose.

SAN DIEGO — Combining an electrocardiogram with serum N-terminal pro-B-type natriuretic peptide measurements is a simple, noninvasive way to diagnose pulmonary hypertension, results from an Austrian study suggest.

“Current pulmonary hypertension diagnosis guidelines say that ECG alone is not useful in the diagnosis of pulmonary hypertension. This is true,” Dr. Diana Bonderman said in an interview during a poster session at an international conference of the American Thoracic Society. “But if you combine ECG with NT-proBNP [N-terminal pro-B-type natriuretic peptide], it's going to be useful.”

The finding is important, she said, because the growing awareness of pulmonary hypertension PH, a high prevalence of postcapillary PH, and the inability to discern between pre- and postcapillary PH by transthoracic echocardiography (TTE) “have led to unnecessary right heart catheterizations.”

She and her associates prospectively analyzed data from 121 patients referred to the Medical University of Vienna between April 2007 and October 2008 for clinical and transthoracic echocardiographic suspicion of precapillary pulmonary hypertension (defined as having a systolic pulmonary artery pressure of at least 36 mm Hg). On admission, all patients underwent TTE, serum analysis including NT-proBNP, a 6-minute walk test, and blood gas analysis.

The patients were then assigned to one of two predicted diagnostic groups: precapillary PH (defined as right ventricular strain on ECG and/or serum NT-proBNP of greater than 80 pg/mL) or no precapillary PH (defined as no right ventricular strain on ECG and NT-proBNP of 80 pg/mL or less). Next, all patients underwent invasive hemodynamic measurements by right heart catheterization, and a final diagnosis was established.

The mean age of the patients was 62 years and 59% were female, reported Dr. Bonderman, a cardiologist at the Medical University of Vienna.

By right heart catheterization, 64 (53%) patients were diagnosed with precapillary PH. Precapillary PH was ruled out in 57 (47%) patients. By the diagnostic algorithm, 15 patients (12%) had been correctly allocated to the group without precapillary PH (true negatives). None of the allocations was a false negative.

“In the diagnostic pathway of PH, integration of the proposed algorithm subsequent to TTE may increase specificity from 0% to 19.3%, with a sensitivity of 100%,” the researchers wrote. “The incorporation of ECG and NT-proBNP into the workup of PH provides incremental diagnostic value and may significantly reduce the number of invasive assessments.”

The researchers had no conflicts to disclose.

SAN DIEGO — Combining an electrocardiogram with serum N-terminal pro-B-type natriuretic peptide measurements is a simple, noninvasive way to diagnose pulmonary hypertension, results from an Austrian study suggest.

“Current pulmonary hypertension diagnosis guidelines say that ECG alone is not useful in the diagnosis of pulmonary hypertension. This is true,” Dr. Diana Bonderman said in an interview during a poster session at an international conference of the American Thoracic Society. “But if you combine ECG with NT-proBNP [N-terminal pro-B-type natriuretic peptide], it's going to be useful.”

The finding is important, she said, because the growing awareness of pulmonary hypertension PH, a high prevalence of postcapillary PH, and the inability to discern between pre- and postcapillary PH by transthoracic echocardiography (TTE) “have led to unnecessary right heart catheterizations.”

She and her associates prospectively analyzed data from 121 patients referred to the Medical University of Vienna between April 2007 and October 2008 for clinical and transthoracic echocardiographic suspicion of precapillary pulmonary hypertension (defined as having a systolic pulmonary artery pressure of at least 36 mm Hg). On admission, all patients underwent TTE, serum analysis including NT-proBNP, a 6-minute walk test, and blood gas analysis.

The patients were then assigned to one of two predicted diagnostic groups: precapillary PH (defined as right ventricular strain on ECG and/or serum NT-proBNP of greater than 80 pg/mL) or no precapillary PH (defined as no right ventricular strain on ECG and NT-proBNP of 80 pg/mL or less). Next, all patients underwent invasive hemodynamic measurements by right heart catheterization, and a final diagnosis was established.

The mean age of the patients was 62 years and 59% were female, reported Dr. Bonderman, a cardiologist at the Medical University of Vienna.

By right heart catheterization, 64 (53%) patients were diagnosed with precapillary PH. Precapillary PH was ruled out in 57 (47%) patients. By the diagnostic algorithm, 15 patients (12%) had been correctly allocated to the group without precapillary PH (true negatives). None of the allocations was a false negative.

“In the diagnostic pathway of PH, integration of the proposed algorithm subsequent to TTE may increase specificity from 0% to 19.3%, with a sensitivity of 100%,” the researchers wrote. “The incorporation of ECG and NT-proBNP into the workup of PH provides incremental diagnostic value and may significantly reduce the number of invasive assessments.”

The researchers had no conflicts to disclose.