Heart Failure

SEATTLE — A heart rate of 90 beats per minute was detrimental in a study of pacemaker-dependent patients with heart failure, Krishnamurti Rao reported at the annual meeting of the Heart Failure Society of America.

Thirteen patients in a crossover study spent 2 months with the heart rate set at 60, 75, or 90 beats per minute (bpm), then were randomized to 2 months at one of the other settings, and then 2 months at the third of the three settings. At 90 bpm, patients had significantly lower ejection fractions and reduced exercise tolerance as measured by maximal oxygen consumption (peak VO₂) and walked significantly shorter distances on 6-minute walk tests, compared with the periods when heart rates were set to 75 or 60 bpm.

“These findings suggest that a mild tachycardia of even 90 [bpm], when chronic, can lead to left ventricular dysfunction,” said Mr. Rao, who conducted the study with associates on the faculty of the University of Maryland, Baltimore, and currently is a student at Boston University. He has no affiliation with the companies that make pacemakers or heart medications.

Patients also fared worse clinically at a setting of 90 bpm, compared with the other two settings. Clinical deterioration caused four patients in the 90-bpm period and one patient in the 60-bpm period to discontinue that setting before the end of the 2 months. Symptoms worsened in some patients immediately upon starting the 90-bpm rate and in others several weeks after changing rates, he noted. Two patients had their rates turned down to 85 or 80 bpm 3–4 weeks into the 90-bpm period.

The study could not determine the optimal heart rate. Based on the data available, the investigators suggest that pacemaker rates should not be set at more than 75 bpm.

Mean peak VO₂ at 60 bpm was 11 mL/kg per minute, at 75 bpm was 11.3 mL/kg per minute, and at 90 bpm was 9.5 mL/kg per minute. The exercise tolerance findings may even underestimate the negative effect of the 90 bpm, because one patient who deteriorated clinically was unable to exercise, he said.

Mean ejection fractions at 60 bpm were 33%, at 75 bpm were 30%, and at 90 bpm were 25%. On the 6-minute walk test, the mean distance was 938 feet at 60 bpm, 996 feet at 75 bpm, and 888 feet at 90 bpm.

Chronic use of β-blockers is known to improve cardiac function, though it has not been clear whether the benefits derive from their effects on heart rate or from other actions, he said.

SEATTLE — A heart rate of 90 beats per minute was detrimental in a study of pacemaker-dependent patients with heart failure, Krishnamurti Rao reported at the annual meeting of the Heart Failure Society of America.

Thirteen patients in a crossover study spent 2 months with the heart rate set at 60, 75, or 90 beats per minute (bpm), then were randomized to 2 months at one of the other settings, and then 2 months at the third of the three settings. At 90 bpm, patients had significantly lower ejection fractions and reduced exercise tolerance as measured by maximal oxygen consumption (peak VO₂) and walked significantly shorter distances on 6-minute walk tests, compared with the periods when heart rates were set to 75 or 60 bpm.

“These findings suggest that a mild tachycardia of even 90 [bpm], when chronic, can lead to left ventricular dysfunction,” said Mr. Rao, who conducted the study with associates on the faculty of the University of Maryland, Baltimore, and currently is a student at Boston University. He has no affiliation with the companies that make pacemakers or heart medications.

Patients also fared worse clinically at a setting of 90 bpm, compared with the other two settings. Clinical deterioration caused four patients in the 90-bpm period and one patient in the 60-bpm period to discontinue that setting before the end of the 2 months. Symptoms worsened in some patients immediately upon starting the 90-bpm rate and in others several weeks after changing rates, he noted. Two patients had their rates turned down to 85 or 80 bpm 3–4 weeks into the 90-bpm period.

The study could not determine the optimal heart rate. Based on the data available, the investigators suggest that pacemaker rates should not be set at more than 75 bpm.

Mean peak VO₂ at 60 bpm was 11 mL/kg per minute, at 75 bpm was 11.3 mL/kg per minute, and at 90 bpm was 9.5 mL/kg per minute. The exercise tolerance findings may even underestimate the negative effect of the 90 bpm, because one patient who deteriorated clinically was unable to exercise, he said.

Mean ejection fractions at 60 bpm were 33%, at 75 bpm were 30%, and at 90 bpm were 25%. On the 6-minute walk test, the mean distance was 938 feet at 60 bpm, 996 feet at 75 bpm, and 888 feet at 90 bpm.

Chronic use of β-blockers is known to improve cardiac function, though it has not been clear whether the benefits derive from their effects on heart rate or from other actions, he said.

SEATTLE — A heart rate of 90 beats per minute was detrimental in a study of pacemaker-dependent patients with heart failure, Krishnamurti Rao reported at the annual meeting of the Heart Failure Society of America.

Thirteen patients in a crossover study spent 2 months with the heart rate set at 60, 75, or 90 beats per minute (bpm), then were randomized to 2 months at one of the other settings, and then 2 months at the third of the three settings. At 90 bpm, patients had significantly lower ejection fractions and reduced exercise tolerance as measured by maximal oxygen consumption (peak VO₂) and walked significantly shorter distances on 6-minute walk tests, compared with the periods when heart rates were set to 75 or 60 bpm.

“These findings suggest that a mild tachycardia of even 90 [bpm], when chronic, can lead to left ventricular dysfunction,” said Mr. Rao, who conducted the study with associates on the faculty of the University of Maryland, Baltimore, and currently is a student at Boston University. He has no affiliation with the companies that make pacemakers or heart medications.

Patients also fared worse clinically at a setting of 90 bpm, compared with the other two settings. Clinical deterioration caused four patients in the 90-bpm period and one patient in the 60-bpm period to discontinue that setting before the end of the 2 months. Symptoms worsened in some patients immediately upon starting the 90-bpm rate and in others several weeks after changing rates, he noted. Two patients had their rates turned down to 85 or 80 bpm 3–4 weeks into the 90-bpm period.

The study could not determine the optimal heart rate. Based on the data available, the investigators suggest that pacemaker rates should not be set at more than 75 bpm.

Mean peak VO₂ at 60 bpm was 11 mL/kg per minute, at 75 bpm was 11.3 mL/kg per minute, and at 90 bpm was 9.5 mL/kg per minute. The exercise tolerance findings may even underestimate the negative effect of the 90 bpm, because one patient who deteriorated clinically was unable to exercise, he said.

Mean ejection fractions at 60 bpm were 33%, at 75 bpm were 30%, and at 90 bpm were 25%. On the 6-minute walk test, the mean distance was 938 feet at 60 bpm, 996 feet at 75 bpm, and 888 feet at 90 bpm.

Chronic use of β-blockers is known to improve cardiac function, though it has not been clear whether the benefits derive from their effects on heart rate or from other actions, he said.

SEATTLE — Adding an angiotensin receptor blocker to ACE inhibitor therapy in patients with heart failure significantly increased the risk of hypotension and renal failure, with a trend toward an increased risk for hyperkalemia, compared with ACE inhibitor therapy alone, in a meta-analysis of randomized, controlled trials, Dr. Rachid Lakhdar reported.

A previous meta-analysis of randomized, controlled studies found that combination therapy with an angiotensin receptor blocker (ARB) and an ACE inhibitor reduced hospitalizations in patients with heart failure but provided no survival benefit, he said in poster presentation at the annual meeting of the Heart Failure Society of America. The earlier meta-analysis did not analyze the safety of this drug combination.

Dr. Lakhdar and his coinvestigator, Dr. Mouaz H. Al-Mallah, both of Henry Ford Hospital, Detroit, searched the medical literature and abstracts from medical meetings and analyzed safety data from nine studies including 18,160 patients with heart failure. The incidence of side effects was low but was 25% higher in the combination therapy arms, compared with ACE inhibitor therapy alone, they reported.

Patients on combined therapy were 54% more likely to develop hypotension and twice as likely to develop worsened renal function, compared with patients on an ACE inhibitor alone. A 2.5-fold increase in risk for hyperkalemia was not statistically significant.

“Those side effects—hypotension, hyperkalemia, and renal failure—are related directly or indirectly to reduced angiotensin II formation,” the investigators noted. The rates of cough and angioedema did not differ significantly between groups.

Not all the studies showed a significant increase in side effects with the combination therapy, perhaps owing to small sample size, short follow-up, or the characteristics of different drugs and doses. The longer trials found more side effects than shorter trials did, so it may be that some adverse events associated with the combination therapy would have shown up over time, Dr. Lakhdar and Dr. Al-Mallah suggested. “The presence of this excess risk, lack of a definitive survival benefit of this strategy, and the availability of other agents with proven survival benefit in heart failure in combination with ACE inhibitors suggests that the addition of an ARB to ACE inhibitor therapy should be discouraged,” they said.

The investigators reported that they have no associations with the companies that make the drugs.

SEATTLE — Adding an angiotensin receptor blocker to ACE inhibitor therapy in patients with heart failure significantly increased the risk of hypotension and renal failure, with a trend toward an increased risk for hyperkalemia, compared with ACE inhibitor therapy alone, in a meta-analysis of randomized, controlled trials, Dr. Rachid Lakhdar reported.

A previous meta-analysis of randomized, controlled studies found that combination therapy with an angiotensin receptor blocker (ARB) and an ACE inhibitor reduced hospitalizations in patients with heart failure but provided no survival benefit, he said in poster presentation at the annual meeting of the Heart Failure Society of America. The earlier meta-analysis did not analyze the safety of this drug combination.

Dr. Lakhdar and his coinvestigator, Dr. Mouaz H. Al-Mallah, both of Henry Ford Hospital, Detroit, searched the medical literature and abstracts from medical meetings and analyzed safety data from nine studies including 18,160 patients with heart failure. The incidence of side effects was low but was 25% higher in the combination therapy arms, compared with ACE inhibitor therapy alone, they reported.

Patients on combined therapy were 54% more likely to develop hypotension and twice as likely to develop worsened renal function, compared with patients on an ACE inhibitor alone. A 2.5-fold increase in risk for hyperkalemia was not statistically significant.

“Those side effects—hypotension, hyperkalemia, and renal failure—are related directly or indirectly to reduced angiotensin II formation,” the investigators noted. The rates of cough and angioedema did not differ significantly between groups.

Not all the studies showed a significant increase in side effects with the combination therapy, perhaps owing to small sample size, short follow-up, or the characteristics of different drugs and doses. The longer trials found more side effects than shorter trials did, so it may be that some adverse events associated with the combination therapy would have shown up over time, Dr. Lakhdar and Dr. Al-Mallah suggested. “The presence of this excess risk, lack of a definitive survival benefit of this strategy, and the availability of other agents with proven survival benefit in heart failure in combination with ACE inhibitors suggests that the addition of an ARB to ACE inhibitor therapy should be discouraged,” they said.

The investigators reported that they have no associations with the companies that make the drugs.

SEATTLE — Adding an angiotensin receptor blocker to ACE inhibitor therapy in patients with heart failure significantly increased the risk of hypotension and renal failure, with a trend toward an increased risk for hyperkalemia, compared with ACE inhibitor therapy alone, in a meta-analysis of randomized, controlled trials, Dr. Rachid Lakhdar reported.

A previous meta-analysis of randomized, controlled studies found that combination therapy with an angiotensin receptor blocker (ARB) and an ACE inhibitor reduced hospitalizations in patients with heart failure but provided no survival benefit, he said in poster presentation at the annual meeting of the Heart Failure Society of America. The earlier meta-analysis did not analyze the safety of this drug combination.

Dr. Lakhdar and his coinvestigator, Dr. Mouaz H. Al-Mallah, both of Henry Ford Hospital, Detroit, searched the medical literature and abstracts from medical meetings and analyzed safety data from nine studies including 18,160 patients with heart failure. The incidence of side effects was low but was 25% higher in the combination therapy arms, compared with ACE inhibitor therapy alone, they reported.

Patients on combined therapy were 54% more likely to develop hypotension and twice as likely to develop worsened renal function, compared with patients on an ACE inhibitor alone. A 2.5-fold increase in risk for hyperkalemia was not statistically significant.

“Those side effects—hypotension, hyperkalemia, and renal failure—are related directly or indirectly to reduced angiotensin II formation,” the investigators noted. The rates of cough and angioedema did not differ significantly between groups.

Not all the studies showed a significant increase in side effects with the combination therapy, perhaps owing to small sample size, short follow-up, or the characteristics of different drugs and doses. The longer trials found more side effects than shorter trials did, so it may be that some adverse events associated with the combination therapy would have shown up over time, Dr. Lakhdar and Dr. Al-Mallah suggested. “The presence of this excess risk, lack of a definitive survival benefit of this strategy, and the availability of other agents with proven survival benefit in heart failure in combination with ACE inhibitors suggests that the addition of an ARB to ACE inhibitor therapy should be discouraged,” they said.

The investigators reported that they have no associations with the companies that make the drugs.

BARCELONA — Treatment with the ACE inhibitor perindopril appeared to help elderly patients with left ventricular diastolic dysfunction in a study with about 850 patients.

The study was plagued by underenrollment and by many patients changing medications from their assigned study regimens, and this may explain why the results failed to show a statistically significant difference in favor of perindopril for the primary end point of all-cause death or unplanned hospitalization for heart failure. But post hoc and secondary analyses of the data suggested that treatment with the ACE inhibitor led to improved patient outcomes, including fewer hospitalizations for heart failure, fewer days in the hospital, improved heart failure status, and improved exercise capacity, Dr. John G.F. Cleland reported at a joint meeting of the European Society of Cardiology and the World Heart Federation.

“These data should not be wasted due to methodologic problems; we need to understand what the data are telling us,” commented Dr. Kenneth Dickstein, a cardiologist and professor of medicine at the University of Bergen in Stavanger, Norway. Agreeing with Dr. Cleland's interpretation, Dr. Dickstein concluded that the results “support a role for inhibition of the renin-angiotensin system in patients with heart failure and preserved systolic function.”

This finding is important because although blockade of the renin-angiotensin system with an ACE inhibitor or angiotensin-receptor blocker is standard treatment for LV systolic dysfunction, scant data exist to prove the treatment's value in patients with preserved LV function and diastolic dysfunction. The only study to address this until now was the Candesartan in Heart Failure—Assessment of Reduction in Mortality and Morbidity (CHARM) trial, specifically the CHARM-Preserved part of the study that assessed the efficacy of candesartan in patients with heart failure and a LV ejection fraction of at least 40% (Lancet 2003;362:777–81). The new findings are consistent with the CHARM-Preserved results, Dr. Dickstein said.

The Perindopril in Elderly People With Chronic Heart Failure (PEP-CHF) study enrolled patients aged 70 or older with evidence of diastolic dysfunction. The only background medication that patients had to receive was a diuretic. Patients were randomized to treatment with either 2 mg/day perindopril or placebo. The perindopril dosage was later raised to 4 mg/day if patients had no contraindication to the increased dosage.

The study was sponsored by Servier, which markets perindopril (Acenon). Dr. Cleland and his associates received payments from Servier for working on the study.

The initial statistical calculations called for enrolling about 1,000 patients into the trial, but only 852 entered the study because of slow recruitment. The average age of the enrolled patients was 75, and their average LV ejection fraction was about 65%. About three-quarters of patients had New York Heart Association class I or II heart failure.

Although 90% of patients remained on their assigned therapy after their first year in the study, after 18 months about 40% of patients had stopped their assigned regimen, which Dr. Cleland attributed to the difficulty of keeping older patients on a blinded regimen. Another problem was a much lower than anticipated event rate. The study design anticipated that 50% of patients would have the primary end point of death or heart-failure hospitalization each year. Instead, the actual rate for this end point was 12.7%. Patients were followed for an average of 2.2 years.

For the complete follow-up period, the incidence of the primary end point had a relative rate reduction of 8% in the patients treated with perindopril, a nonsignificant difference. Perindopril treatment also failed to produce a significant reduction in unplanned hospitalizations for heart failure.

But in a post-hoc analysis that focused only on outcomes during the first year of follow-up, when most patients remained on their assigned regimen, the incidence of the primary end point was 10.8% in the perindopril group and 15.3% in the placebo group, a 31% relative reduction that was statistically significant. Also at 1 year, the incidence of unplanned heart failure hospitalizations was reduced by 37% in the perindopril group, compared with the placebo group, also a significant difference.

The 1-year results “are probably the truth and what the study is trying to tell us,” Dr. Dickstein commented.

Additional analysis of data collected in PEP-CHF indicated that patients with a serum level of N-terminal pro-brain natriuretic peptide (NT-proBNP, a marker of cardiac stress) below the median of 400 pg/mL had event rates similar to those in the normal elderly population. In contrast, patients whose level was above the median had event rates that were similar to those in patients with systolic heart failure who benefited when they were treated with perindopril. This finding suggested that NT-proBNP might be a useful marker for predicting the efficacy of ACE inhibitor treatment in patients with diastolic heart failure, Dr. Cleland said in an interview.

BARCELONA — Treatment with the ACE inhibitor perindopril appeared to help elderly patients with left ventricular diastolic dysfunction in a study with about 850 patients.

The study was plagued by underenrollment and by many patients changing medications from their assigned study regimens, and this may explain why the results failed to show a statistically significant difference in favor of perindopril for the primary end point of all-cause death or unplanned hospitalization for heart failure. But post hoc and secondary analyses of the data suggested that treatment with the ACE inhibitor led to improved patient outcomes, including fewer hospitalizations for heart failure, fewer days in the hospital, improved heart failure status, and improved exercise capacity, Dr. John G.F. Cleland reported at a joint meeting of the European Society of Cardiology and the World Heart Federation.

“These data should not be wasted due to methodologic problems; we need to understand what the data are telling us,” commented Dr. Kenneth Dickstein, a cardiologist and professor of medicine at the University of Bergen in Stavanger, Norway. Agreeing with Dr. Cleland's interpretation, Dr. Dickstein concluded that the results “support a role for inhibition of the renin-angiotensin system in patients with heart failure and preserved systolic function.”

This finding is important because although blockade of the renin-angiotensin system with an ACE inhibitor or angiotensin-receptor blocker is standard treatment for LV systolic dysfunction, scant data exist to prove the treatment's value in patients with preserved LV function and diastolic dysfunction. The only study to address this until now was the Candesartan in Heart Failure—Assessment of Reduction in Mortality and Morbidity (CHARM) trial, specifically the CHARM-Preserved part of the study that assessed the efficacy of candesartan in patients with heart failure and a LV ejection fraction of at least 40% (Lancet 2003;362:777–81). The new findings are consistent with the CHARM-Preserved results, Dr. Dickstein said.

The Perindopril in Elderly People With Chronic Heart Failure (PEP-CHF) study enrolled patients aged 70 or older with evidence of diastolic dysfunction. The only background medication that patients had to receive was a diuretic. Patients were randomized to treatment with either 2 mg/day perindopril or placebo. The perindopril dosage was later raised to 4 mg/day if patients had no contraindication to the increased dosage.

The study was sponsored by Servier, which markets perindopril (Acenon). Dr. Cleland and his associates received payments from Servier for working on the study.

The initial statistical calculations called for enrolling about 1,000 patients into the trial, but only 852 entered the study because of slow recruitment. The average age of the enrolled patients was 75, and their average LV ejection fraction was about 65%. About three-quarters of patients had New York Heart Association class I or II heart failure.

Although 90% of patients remained on their assigned therapy after their first year in the study, after 18 months about 40% of patients had stopped their assigned regimen, which Dr. Cleland attributed to the difficulty of keeping older patients on a blinded regimen. Another problem was a much lower than anticipated event rate. The study design anticipated that 50% of patients would have the primary end point of death or heart-failure hospitalization each year. Instead, the actual rate for this end point was 12.7%. Patients were followed for an average of 2.2 years.

For the complete follow-up period, the incidence of the primary end point had a relative rate reduction of 8% in the patients treated with perindopril, a nonsignificant difference. Perindopril treatment also failed to produce a significant reduction in unplanned hospitalizations for heart failure.

But in a post-hoc analysis that focused only on outcomes during the first year of follow-up, when most patients remained on their assigned regimen, the incidence of the primary end point was 10.8% in the perindopril group and 15.3% in the placebo group, a 31% relative reduction that was statistically significant. Also at 1 year, the incidence of unplanned heart failure hospitalizations was reduced by 37% in the perindopril group, compared with the placebo group, also a significant difference.

The 1-year results “are probably the truth and what the study is trying to tell us,” Dr. Dickstein commented.

Additional analysis of data collected in PEP-CHF indicated that patients with a serum level of N-terminal pro-brain natriuretic peptide (NT-proBNP, a marker of cardiac stress) below the median of 400 pg/mL had event rates similar to those in the normal elderly population. In contrast, patients whose level was above the median had event rates that were similar to those in patients with systolic heart failure who benefited when they were treated with perindopril. This finding suggested that NT-proBNP might be a useful marker for predicting the efficacy of ACE inhibitor treatment in patients with diastolic heart failure, Dr. Cleland said in an interview.

BARCELONA — Treatment with the ACE inhibitor perindopril appeared to help elderly patients with left ventricular diastolic dysfunction in a study with about 850 patients.

The study was plagued by underenrollment and by many patients changing medications from their assigned study regimens, and this may explain why the results failed to show a statistically significant difference in favor of perindopril for the primary end point of all-cause death or unplanned hospitalization for heart failure. But post hoc and secondary analyses of the data suggested that treatment with the ACE inhibitor led to improved patient outcomes, including fewer hospitalizations for heart failure, fewer days in the hospital, improved heart failure status, and improved exercise capacity, Dr. John G.F. Cleland reported at a joint meeting of the European Society of Cardiology and the World Heart Federation.

“These data should not be wasted due to methodologic problems; we need to understand what the data are telling us,” commented Dr. Kenneth Dickstein, a cardiologist and professor of medicine at the University of Bergen in Stavanger, Norway. Agreeing with Dr. Cleland's interpretation, Dr. Dickstein concluded that the results “support a role for inhibition of the renin-angiotensin system in patients with heart failure and preserved systolic function.”

This finding is important because although blockade of the renin-angiotensin system with an ACE inhibitor or angiotensin-receptor blocker is standard treatment for LV systolic dysfunction, scant data exist to prove the treatment's value in patients with preserved LV function and diastolic dysfunction. The only study to address this until now was the Candesartan in Heart Failure—Assessment of Reduction in Mortality and Morbidity (CHARM) trial, specifically the CHARM-Preserved part of the study that assessed the efficacy of candesartan in patients with heart failure and a LV ejection fraction of at least 40% (Lancet 2003;362:777–81). The new findings are consistent with the CHARM-Preserved results, Dr. Dickstein said.

The Perindopril in Elderly People With Chronic Heart Failure (PEP-CHF) study enrolled patients aged 70 or older with evidence of diastolic dysfunction. The only background medication that patients had to receive was a diuretic. Patients were randomized to treatment with either 2 mg/day perindopril or placebo. The perindopril dosage was later raised to 4 mg/day if patients had no contraindication to the increased dosage.

The study was sponsored by Servier, which markets perindopril (Acenon). Dr. Cleland and his associates received payments from Servier for working on the study.

The initial statistical calculations called for enrolling about 1,000 patients into the trial, but only 852 entered the study because of slow recruitment. The average age of the enrolled patients was 75, and their average LV ejection fraction was about 65%. About three-quarters of patients had New York Heart Association class I or II heart failure.

Although 90% of patients remained on their assigned therapy after their first year in the study, after 18 months about 40% of patients had stopped their assigned regimen, which Dr. Cleland attributed to the difficulty of keeping older patients on a blinded regimen. Another problem was a much lower than anticipated event rate. The study design anticipated that 50% of patients would have the primary end point of death or heart-failure hospitalization each year. Instead, the actual rate for this end point was 12.7%. Patients were followed for an average of 2.2 years.

For the complete follow-up period, the incidence of the primary end point had a relative rate reduction of 8% in the patients treated with perindopril, a nonsignificant difference. Perindopril treatment also failed to produce a significant reduction in unplanned hospitalizations for heart failure.

But in a post-hoc analysis that focused only on outcomes during the first year of follow-up, when most patients remained on their assigned regimen, the incidence of the primary end point was 10.8% in the perindopril group and 15.3% in the placebo group, a 31% relative reduction that was statistically significant. Also at 1 year, the incidence of unplanned heart failure hospitalizations was reduced by 37% in the perindopril group, compared with the placebo group, also a significant difference.

The 1-year results “are probably the truth and what the study is trying to tell us,” Dr. Dickstein commented.

Additional analysis of data collected in PEP-CHF indicated that patients with a serum level of N-terminal pro-brain natriuretic peptide (NT-proBNP, a marker of cardiac stress) below the median of 400 pg/mL had event rates similar to those in the normal elderly population. In contrast, patients whose level was above the median had event rates that were similar to those in patients with systolic heart failure who benefited when they were treated with perindopril. This finding suggested that NT-proBNP might be a useful marker for predicting the efficacy of ACE inhibitor treatment in patients with diastolic heart failure, Dr. Cleland said in an interview.

SEATTLE — Maximizing heart failure therapy helps treat concomitant sleep apnea, Dr. David P. White said at the annual meeting of the Heart Failure Society of America.

Beyond that, treatment for sleep apnea in patients with heart failure relies mainly on continuous positive airway pressure (CPAP), which can regularize disordered breathing and which may improve ejection fraction and quality of life. There are no randomized trial data, however, showing that treating sleep apnea in patients with heart failure decreases mortality or the need for heart transplant, added Dr. White, professor of medicine at Harvard University, Boston.

The most common type of disordered breathing in heart failure patients is Cheyne-Stokes respiration, a variant of central sleep apnea. A number of short, single-center trials suggested that CPAP in patients with heart failure and either central or obstructive sleep apnea could stabilize respiration, improve cardiac function and quality of life, and perhaps reduce the need for cardiac transplantation.

The only randomized, placebo-controlled trial, however, looked at CPAP for patients with heart failure and Cheyne-Stokes respiration and found no difference in quality of life, mortality, or the need for transplant. In the Canadian Positive Airway Pressure trial, CPAP did produce a mean 3% improvement in ejection fraction (not the 8% found in single-center studies), improved oxygenation, and led to a small increase in 6-minute walk distances (N. Engl. J. Med. 2005;353:2025–41).

“First, always maximize the cardiac medications,” Dr. White urged. Studies show that the severity of heart failure predicts, to some degree, the extent of disordered breathing. The severity of Cheyne-Stokes respiration predicts survival rates independently of the severity of heart failure, he added. Other studies suggest that resynchronization therapy also can reduce the severity of disordered breathing, though not in all patients.

After that, consider CPAP for heart failure patients with central sleep apnea, or possibly one of several new devices designed specifically to relieve Cheyne-Stokes respiration, he said. The devices do regularize breathing but there are no long-term studies of their effects on survival, quality of life, or other parameters.

Dr. White is chief medical officer of a company that makes a variety of devices to treat sleep apnea, and is a consultant to other companies with apnea treatments.

SEATTLE — Maximizing heart failure therapy helps treat concomitant sleep apnea, Dr. David P. White said at the annual meeting of the Heart Failure Society of America.

Beyond that, treatment for sleep apnea in patients with heart failure relies mainly on continuous positive airway pressure (CPAP), which can regularize disordered breathing and which may improve ejection fraction and quality of life. There are no randomized trial data, however, showing that treating sleep apnea in patients with heart failure decreases mortality or the need for heart transplant, added Dr. White, professor of medicine at Harvard University, Boston.

The most common type of disordered breathing in heart failure patients is Cheyne-Stokes respiration, a variant of central sleep apnea. A number of short, single-center trials suggested that CPAP in patients with heart failure and either central or obstructive sleep apnea could stabilize respiration, improve cardiac function and quality of life, and perhaps reduce the need for cardiac transplantation.

The only randomized, placebo-controlled trial, however, looked at CPAP for patients with heart failure and Cheyne-Stokes respiration and found no difference in quality of life, mortality, or the need for transplant. In the Canadian Positive Airway Pressure trial, CPAP did produce a mean 3% improvement in ejection fraction (not the 8% found in single-center studies), improved oxygenation, and led to a small increase in 6-minute walk distances (N. Engl. J. Med. 2005;353:2025–41).

“First, always maximize the cardiac medications,” Dr. White urged. Studies show that the severity of heart failure predicts, to some degree, the extent of disordered breathing. The severity of Cheyne-Stokes respiration predicts survival rates independently of the severity of heart failure, he added. Other studies suggest that resynchronization therapy also can reduce the severity of disordered breathing, though not in all patients.

After that, consider CPAP for heart failure patients with central sleep apnea, or possibly one of several new devices designed specifically to relieve Cheyne-Stokes respiration, he said. The devices do regularize breathing but there are no long-term studies of their effects on survival, quality of life, or other parameters.

Dr. White is chief medical officer of a company that makes a variety of devices to treat sleep apnea, and is a consultant to other companies with apnea treatments.

SEATTLE — Maximizing heart failure therapy helps treat concomitant sleep apnea, Dr. David P. White said at the annual meeting of the Heart Failure Society of America.

Beyond that, treatment for sleep apnea in patients with heart failure relies mainly on continuous positive airway pressure (CPAP), which can regularize disordered breathing and which may improve ejection fraction and quality of life. There are no randomized trial data, however, showing that treating sleep apnea in patients with heart failure decreases mortality or the need for heart transplant, added Dr. White, professor of medicine at Harvard University, Boston.

The most common type of disordered breathing in heart failure patients is Cheyne-Stokes respiration, a variant of central sleep apnea. A number of short, single-center trials suggested that CPAP in patients with heart failure and either central or obstructive sleep apnea could stabilize respiration, improve cardiac function and quality of life, and perhaps reduce the need for cardiac transplantation.

The only randomized, placebo-controlled trial, however, looked at CPAP for patients with heart failure and Cheyne-Stokes respiration and found no difference in quality of life, mortality, or the need for transplant. In the Canadian Positive Airway Pressure trial, CPAP did produce a mean 3% improvement in ejection fraction (not the 8% found in single-center studies), improved oxygenation, and led to a small increase in 6-minute walk distances (N. Engl. J. Med. 2005;353:2025–41).

“First, always maximize the cardiac medications,” Dr. White urged. Studies show that the severity of heart failure predicts, to some degree, the extent of disordered breathing. The severity of Cheyne-Stokes respiration predicts survival rates independently of the severity of heart failure, he added. Other studies suggest that resynchronization therapy also can reduce the severity of disordered breathing, though not in all patients.

After that, consider CPAP for heart failure patients with central sleep apnea, or possibly one of several new devices designed specifically to relieve Cheyne-Stokes respiration, he said. The devices do regularize breathing but there are no long-term studies of their effects on survival, quality of life, or other parameters.

Dr. White is chief medical officer of a company that makes a variety of devices to treat sleep apnea, and is a consultant to other companies with apnea treatments.

SEATTLE — Patients with heart failure or hypertension who answered “Yes” to at least two of three questions had a high likelihood of having obstructive sleep apnea, Cheryl L. Bartone reported in a poster presentation at the annual meeting of the Heart Failure Society of America.

She and associates compared responses to the screening questionnaire with polysomnography results in 70 outpatients with heart failure or hypertension seen at a cardiology office.

The three-question screening tool was 90% sensitive and 45% specific in detecting obstructive sleep apnea, said Ms. Bartone of the Ohio Heart and Vascular Center, Cincinnati.

The tool had a positive predictive value of 67% and a negative predictive value of 78%.

Patients were asked:

▸ Do you snore loudly?

▸ Do you wake up more than once a night?

▸ Do you have morning fatigue?

Polysomnograms showed that 67 patients had some degree of obstructive sleep apnea, defined as an apnea-hypopnea index of 5 or greater. The obstructive sleep apnea was considered significant in 39 patients who had moderate or severe obstructive sleep apnea, defined as an apnea-hypopnea index of 20 or greater.

Of the 52 patients who answered “Yes” to at least two questions, 32 had significant obstructive sleep apnea. Among the 18 patients who answered “Yes” to only one or none of the questions, 4 had significant obstructive sleep apnea.

Patients with significant obstructive sleep apnea were more likely to be on β-blockers than were those without significant obstructive sleep apnea (82% vs. 74%) and less likely to be on an ACE inhibitor or angiotensin receptor blocker (74% vs. 77%).

Obstructive sleep apnea is a significant contributor to morbidity and mortality in patients with heart failure or hypertension, the investigators said.

There is no other easily applicable screening tool for effective detection of obstructive sleep apnea in these patients, they added. The investigators have no financial conflicts of interest in the study.

The groups with and without significant obstructive sleep apnea did not differ by age, sex, left ventricular ejection fraction, weight, body mass index, or morning fatigue.

SEATTLE — Patients with heart failure or hypertension who answered “Yes” to at least two of three questions had a high likelihood of having obstructive sleep apnea, Cheryl L. Bartone reported in a poster presentation at the annual meeting of the Heart Failure Society of America.

She and associates compared responses to the screening questionnaire with polysomnography results in 70 outpatients with heart failure or hypertension seen at a cardiology office.

The three-question screening tool was 90% sensitive and 45% specific in detecting obstructive sleep apnea, said Ms. Bartone of the Ohio Heart and Vascular Center, Cincinnati.

The tool had a positive predictive value of 67% and a negative predictive value of 78%.

Patients were asked:

▸ Do you snore loudly?

▸ Do you wake up more than once a night?

▸ Do you have morning fatigue?

Polysomnograms showed that 67 patients had some degree of obstructive sleep apnea, defined as an apnea-hypopnea index of 5 or greater. The obstructive sleep apnea was considered significant in 39 patients who had moderate or severe obstructive sleep apnea, defined as an apnea-hypopnea index of 20 or greater.

Of the 52 patients who answered “Yes” to at least two questions, 32 had significant obstructive sleep apnea. Among the 18 patients who answered “Yes” to only one or none of the questions, 4 had significant obstructive sleep apnea.

Patients with significant obstructive sleep apnea were more likely to be on β-blockers than were those without significant obstructive sleep apnea (82% vs. 74%) and less likely to be on an ACE inhibitor or angiotensin receptor blocker (74% vs. 77%).

Obstructive sleep apnea is a significant contributor to morbidity and mortality in patients with heart failure or hypertension, the investigators said.

There is no other easily applicable screening tool for effective detection of obstructive sleep apnea in these patients, they added. The investigators have no financial conflicts of interest in the study.

The groups with and without significant obstructive sleep apnea did not differ by age, sex, left ventricular ejection fraction, weight, body mass index, or morning fatigue.

SEATTLE — Patients with heart failure or hypertension who answered “Yes” to at least two of three questions had a high likelihood of having obstructive sleep apnea, Cheryl L. Bartone reported in a poster presentation at the annual meeting of the Heart Failure Society of America.

She and associates compared responses to the screening questionnaire with polysomnography results in 70 outpatients with heart failure or hypertension seen at a cardiology office.

The three-question screening tool was 90% sensitive and 45% specific in detecting obstructive sleep apnea, said Ms. Bartone of the Ohio Heart and Vascular Center, Cincinnati.

The tool had a positive predictive value of 67% and a negative predictive value of 78%.

Patients were asked:

▸ Do you snore loudly?

▸ Do you wake up more than once a night?

▸ Do you have morning fatigue?

Polysomnograms showed that 67 patients had some degree of obstructive sleep apnea, defined as an apnea-hypopnea index of 5 or greater. The obstructive sleep apnea was considered significant in 39 patients who had moderate or severe obstructive sleep apnea, defined as an apnea-hypopnea index of 20 or greater.

Of the 52 patients who answered “Yes” to at least two questions, 32 had significant obstructive sleep apnea. Among the 18 patients who answered “Yes” to only one or none of the questions, 4 had significant obstructive sleep apnea.

Patients with significant obstructive sleep apnea were more likely to be on β-blockers than were those without significant obstructive sleep apnea (82% vs. 74%) and less likely to be on an ACE inhibitor or angiotensin receptor blocker (74% vs. 77%).

Obstructive sleep apnea is a significant contributor to morbidity and mortality in patients with heart failure or hypertension, the investigators said.

There is no other easily applicable screening tool for effective detection of obstructive sleep apnea in these patients, they added. The investigators have no financial conflicts of interest in the study.

The groups with and without significant obstructive sleep apnea did not differ by age, sex, left ventricular ejection fraction, weight, body mass index, or morning fatigue.

SEATTLE — There is no standard way to screen for sleep apnea in patients with heart failure, but there are several screening models to choose from, Dr. Steven M. Scharf said at the annual meeting of the Heart Failure Society of America.

Sleep apnea commonly accompanies heart failure, and can be treated, though there's little high-quality evidence that treatment alters mortality or quality of life. Still, “I think you certainly should screen all your heart failure patients,” said Dr. Scharf, professor of medicine and director of the sleep disorders lab at the University of Maryland, Baltimore.

One good screening tool is the Berlin Questionnaire, which asks about symptoms in three categories: excessive sleepiness or sleepiness while driving; wild, disturbing snoring or gasping; and either obesity or heart failure (Ann. Intern. Med. 1999;131:485–91). Primary care patients with symptoms in two of the three categories are at high risk of obstructive sleep apnea, but the sensitivity and specificity of the questionnaire in patients with heart failure are unknown, he said.

Other screening schemes stratify patients by neck circumference, with larger necks increasing sleep apnea risk (N. Engl. J. Med. 2002;347:498–91). Other scoring systems combine clinical findings such as male gender, body mass index, a snoring index, and a choking index to rate the likelihood of sleep apnea. Many of these screening models may be useful, Dr. Scharf suggested. (See article at right for another screening tool).

If a heart failure patient seems to have a high probability of sleep apnea (perhaps based on the Berlin Questionnaire and neck circumference), schedule a full polysomnograph evaluation, he advised. Consider doing overnight pulse oximetry testing in heart failure patients who don't meet your threshold for high risk of apnea, he added. A recent metaanalysis of 79 studies that used pulse oximetry for screening suggests that if you have a strong clinical suspicion for obstructive sleep apnea and testing shows fewer than 15 desaturations per hour, diagnostic polysomnography may be warranted (Chest 2001;120:625–33). With more than 15 desaturations per hour, a full evaluation for sleep apnea or treatment with titrated continuous positive airway pressure may be reasonable.

Two articles suggest that an algorithm assessing heart rate variability might help screen for apnea in heart failure patients, but practice parameters don't exist and would need to be developed, he said (Eur. Respir. J. 2006;27:571–7). One small study suggests the PAT100 Watch, which measures peripheral arterial tone, also might help screen for sleep apnea.

Dr. Scharf has no affiliation with companies that sell the tools he discussed.

Patients with symptoms in two of the three Berlin Questionnaire categories are at high risk for apnea. DR. SCHARF

SEATTLE — There is no standard way to screen for sleep apnea in patients with heart failure, but there are several screening models to choose from, Dr. Steven M. Scharf said at the annual meeting of the Heart Failure Society of America.

Sleep apnea commonly accompanies heart failure, and can be treated, though there's little high-quality evidence that treatment alters mortality or quality of life. Still, “I think you certainly should screen all your heart failure patients,” said Dr. Scharf, professor of medicine and director of the sleep disorders lab at the University of Maryland, Baltimore.

One good screening tool is the Berlin Questionnaire, which asks about symptoms in three categories: excessive sleepiness or sleepiness while driving; wild, disturbing snoring or gasping; and either obesity or heart failure (Ann. Intern. Med. 1999;131:485–91). Primary care patients with symptoms in two of the three categories are at high risk of obstructive sleep apnea, but the sensitivity and specificity of the questionnaire in patients with heart failure are unknown, he said.

Other screening schemes stratify patients by neck circumference, with larger necks increasing sleep apnea risk (N. Engl. J. Med. 2002;347:498–91). Other scoring systems combine clinical findings such as male gender, body mass index, a snoring index, and a choking index to rate the likelihood of sleep apnea. Many of these screening models may be useful, Dr. Scharf suggested. (See article at right for another screening tool).

If a heart failure patient seems to have a high probability of sleep apnea (perhaps based on the Berlin Questionnaire and neck circumference), schedule a full polysomnograph evaluation, he advised. Consider doing overnight pulse oximetry testing in heart failure patients who don't meet your threshold for high risk of apnea, he added. A recent metaanalysis of 79 studies that used pulse oximetry for screening suggests that if you have a strong clinical suspicion for obstructive sleep apnea and testing shows fewer than 15 desaturations per hour, diagnostic polysomnography may be warranted (Chest 2001;120:625–33). With more than 15 desaturations per hour, a full evaluation for sleep apnea or treatment with titrated continuous positive airway pressure may be reasonable.

Two articles suggest that an algorithm assessing heart rate variability might help screen for apnea in heart failure patients, but practice parameters don't exist and would need to be developed, he said (Eur. Respir. J. 2006;27:571–7). One small study suggests the PAT100 Watch, which measures peripheral arterial tone, also might help screen for sleep apnea.

Dr. Scharf has no affiliation with companies that sell the tools he discussed.

Patients with symptoms in two of the three Berlin Questionnaire categories are at high risk for apnea. DR. SCHARF

SEATTLE — There is no standard way to screen for sleep apnea in patients with heart failure, but there are several screening models to choose from, Dr. Steven M. Scharf said at the annual meeting of the Heart Failure Society of America.

Sleep apnea commonly accompanies heart failure, and can be treated, though there's little high-quality evidence that treatment alters mortality or quality of life. Still, “I think you certainly should screen all your heart failure patients,” said Dr. Scharf, professor of medicine and director of the sleep disorders lab at the University of Maryland, Baltimore.

One good screening tool is the Berlin Questionnaire, which asks about symptoms in three categories: excessive sleepiness or sleepiness while driving; wild, disturbing snoring or gasping; and either obesity or heart failure (Ann. Intern. Med. 1999;131:485–91). Primary care patients with symptoms in two of the three categories are at high risk of obstructive sleep apnea, but the sensitivity and specificity of the questionnaire in patients with heart failure are unknown, he said.

Other screening schemes stratify patients by neck circumference, with larger necks increasing sleep apnea risk (N. Engl. J. Med. 2002;347:498–91). Other scoring systems combine clinical findings such as male gender, body mass index, a snoring index, and a choking index to rate the likelihood of sleep apnea. Many of these screening models may be useful, Dr. Scharf suggested. (See article at right for another screening tool).

If a heart failure patient seems to have a high probability of sleep apnea (perhaps based on the Berlin Questionnaire and neck circumference), schedule a full polysomnograph evaluation, he advised. Consider doing overnight pulse oximetry testing in heart failure patients who don't meet your threshold for high risk of apnea, he added. A recent metaanalysis of 79 studies that used pulse oximetry for screening suggests that if you have a strong clinical suspicion for obstructive sleep apnea and testing shows fewer than 15 desaturations per hour, diagnostic polysomnography may be warranted (Chest 2001;120:625–33). With more than 15 desaturations per hour, a full evaluation for sleep apnea or treatment with titrated continuous positive airway pressure may be reasonable.

Two articles suggest that an algorithm assessing heart rate variability might help screen for apnea in heart failure patients, but practice parameters don't exist and would need to be developed, he said (Eur. Respir. J. 2006;27:571–7). One small study suggests the PAT100 Watch, which measures peripheral arterial tone, also might help screen for sleep apnea.

Dr. Scharf has no affiliation with companies that sell the tools he discussed.

Patients with symptoms in two of the three Berlin Questionnaire categories are at high risk for apnea. DR. SCHARF

SEATTLE — Cardiologists outperformed internists, family physicians, and other specialists in meeting the measures of care for hospitalized patients with heart failure prescribed by the Joint Commission on Accreditation of Healthcare Organizations, Kismet D. Rasmusson reported.

A study of care within the 20-hospital Intermountain Healthcare system, which handled 2,000 admissions for a primary diagnosis of heart failure in 2005, assessed documentation of three aspects of care mandated by the Joint Commission (JCAHO) for evidence-based care of heart failure. Intermountain Healthcare employs about 400 physicians, mainly in primary care, and is affiliated with 2,500 more physicians, mainly specialists.

Results showed that internists cared for 31% of patients admitted for the first time with a primary diagnosis of heart failure during 2002–2006. Family physicians handled 19%, cardiologists or thoracic surgeons provided 22% of care, and other specialists handled the remainder of care for heart failure, she and her associates reported in a poster presentation.

Overall, 62% of cardiologists documented compliance with all three measures of heart failure care, compared with 43% of noncardiologists, said Ms. Rasmusson, a family nurse practitioner at LDS Hospital, Salt Lake City.

Noncardiologists were more likely to comply with only one, two, or none of the measures, documentation suggested.

The JCAHO requires documentation of four steps in caring for hospitalized heart failure patients:

1. Measurement of left ventricular function in the past, or planned measurement after discharge.

2. Prescription of an ACE inhibitor or an angiotensin receptor blocker when the left ventricular ejection fraction is 40% or lower, unless the drugs are contraindicated.

3. Providing self-management education to patients.

4. Providing smoking cessation counseling (the study did not include this measure because of the low numbers of smokers).

Previous studies have shown that compliance with these measures is associated with improved patient outcomes. “Health systems need to either increase the numbers of cardiologists providing heart failure care or improve care provided by noncardiologists,” the investigators concluded.

SEATTLE — Cardiologists outperformed internists, family physicians, and other specialists in meeting the measures of care for hospitalized patients with heart failure prescribed by the Joint Commission on Accreditation of Healthcare Organizations, Kismet D. Rasmusson reported.

A study of care within the 20-hospital Intermountain Healthcare system, which handled 2,000 admissions for a primary diagnosis of heart failure in 2005, assessed documentation of three aspects of care mandated by the Joint Commission (JCAHO) for evidence-based care of heart failure. Intermountain Healthcare employs about 400 physicians, mainly in primary care, and is affiliated with 2,500 more physicians, mainly specialists.

Results showed that internists cared for 31% of patients admitted for the first time with a primary diagnosis of heart failure during 2002–2006. Family physicians handled 19%, cardiologists or thoracic surgeons provided 22% of care, and other specialists handled the remainder of care for heart failure, she and her associates reported in a poster presentation.

Overall, 62% of cardiologists documented compliance with all three measures of heart failure care, compared with 43% of noncardiologists, said Ms. Rasmusson, a family nurse practitioner at LDS Hospital, Salt Lake City.

Noncardiologists were more likely to comply with only one, two, or none of the measures, documentation suggested.

The JCAHO requires documentation of four steps in caring for hospitalized heart failure patients:

1. Measurement of left ventricular function in the past, or planned measurement after discharge.

2. Prescription of an ACE inhibitor or an angiotensin receptor blocker when the left ventricular ejection fraction is 40% or lower, unless the drugs are contraindicated.

3. Providing self-management education to patients.

4. Providing smoking cessation counseling (the study did not include this measure because of the low numbers of smokers).

Previous studies have shown that compliance with these measures is associated with improved patient outcomes. “Health systems need to either increase the numbers of cardiologists providing heart failure care or improve care provided by noncardiologists,” the investigators concluded.

SEATTLE — Cardiologists outperformed internists, family physicians, and other specialists in meeting the measures of care for hospitalized patients with heart failure prescribed by the Joint Commission on Accreditation of Healthcare Organizations, Kismet D. Rasmusson reported.

A study of care within the 20-hospital Intermountain Healthcare system, which handled 2,000 admissions for a primary diagnosis of heart failure in 2005, assessed documentation of three aspects of care mandated by the Joint Commission (JCAHO) for evidence-based care of heart failure. Intermountain Healthcare employs about 400 physicians, mainly in primary care, and is affiliated with 2,500 more physicians, mainly specialists.

Results showed that internists cared for 31% of patients admitted for the first time with a primary diagnosis of heart failure during 2002–2006. Family physicians handled 19%, cardiologists or thoracic surgeons provided 22% of care, and other specialists handled the remainder of care for heart failure, she and her associates reported in a poster presentation.

Overall, 62% of cardiologists documented compliance with all three measures of heart failure care, compared with 43% of noncardiologists, said Ms. Rasmusson, a family nurse practitioner at LDS Hospital, Salt Lake City.

Noncardiologists were more likely to comply with only one, two, or none of the measures, documentation suggested.

The JCAHO requires documentation of four steps in caring for hospitalized heart failure patients:

1. Measurement of left ventricular function in the past, or planned measurement after discharge.

2. Prescription of an ACE inhibitor or an angiotensin receptor blocker when the left ventricular ejection fraction is 40% or lower, unless the drugs are contraindicated.

3. Providing self-management education to patients.

4. Providing smoking cessation counseling (the study did not include this measure because of the low numbers of smokers).

Previous studies have shown that compliance with these measures is associated with improved patient outcomes. “Health systems need to either increase the numbers of cardiologists providing heart failure care or improve care provided by noncardiologists,” the investigators concluded.

BARCELONA — Researchers moved a step closer toward proving that correcting the anemia that often occurs in patients with heart failure improves outcomes, with results from three phase II studies that tested two different ways to boost hemoglobin levels.

Reports from two controlled studies that compared darbepoetin alfa with placebo in 475 patients showed that the treatment was safe, that it produced improvements in patients' exercise capacity that were tied to boosts in hemoglobin levels, and that the drug could cut the rate of death or hospitalization for heart failure at a rate that approached statistical significance, Dr. William T. Abraham reported at a joint meeting of the European Society of Cardiology and the World Heart Federation.

And results from the first randomized, observer-blinded test of intravenous iron in 35 patients with heart failure and low iron levels supported the idea that iron repletion is safe and associated with improvement in exercise capacity and heart failure symptoms, Dr. Stefan D. Anker said in a separate report at the meeting.

Anemia is a common complication of heart failure, but just how common depends on how it's defined. In data collected from one recent, large heart failure treatment trial, 30% of women and 16% of men had anemia if it was defined as a serum hemoglobin level of less than 12.5 g/dL. With a more conservative definition of less than 11.5 g/dL, the prevalence was 10% among women and 8% among men, said Dr. Anker, a cardiologist and professor of medicine at Charité University in Berlin.

These hemoglobin levels would not be severe enough to warrant drug interventions if they occurred in otherwise healthy people, in whom the hemoglobin level would have to be less than 10 g/dL to make drug intervention reasonable, Dr. Anker said in an interview. But in the context of heart failure, experts have hypothesized that higher hemoglobin levels might lead to clinically important improvements in exercise capacity and quality of life, and to a significant drop in heart failure hospitalizations.

The two most obvious ways to correct anemia are treatment with an erythropoietin agent and treatment with iron supplementation. These approaches could also be used together.

Three phase II studies of darbepoetin alfa, a long-acting erythropoietin, were recently completed, and results from the two largest of these studies were reported at the meeting. All three studies were sponsored by Amgen, which markets darbepoetin (Aranesp). Dr. Abraham has received research support from Amgen.

One trial involved 319 patients with New York Heart Association class II-IV heart failure and a serum hemoglobin level of 9.0–12.5 g/dL; their average baseline hemoglobin level was 11.35 g/dL. Of the 319 patients, 157 were randomized to receive placebo and 162 received darbepoetin alfa at a starting dosage of 0.75 mcg/kg administered subcutaneously every 2 weeks. The dosage was titrated to produce a rise in hemoglobin of 0.5–1.5 g/dL every 3 weeks and then to maintain a hemoglobin level of 13.0–15.0 g/dL. All patients also received supplemental iron, given as an oral dosage of 200 mg/day.

The primary end point for this study was the change in exercise capacity from baseline after 6 months of treatment, measured as time spent walking on a treadmill.

The regimen produced an average hemoglobin level of 13.5 g/dL in patients who were treated with darbepoetin alfa and no change in the patients treated with placebo.

The change in treadmill-exercise time was an average of 46.5 seconds in placebo patients and 57.3 seconds in the darbepoetin alfa-treated patients, a nonsignificant difference, reported Dr. Abraham, professor of medicine and director of the division of cardiovascular medicine at Ohio State University, Columbus.

However, a post hoc analysis of these data showed a promising and statistically significant link between the rise in serum hemoglobin level and improvements in exercise time (see graph). More than 80% of patients treated with darbepoetin alfa had a “robust response to treatment,” with a hemoglobin rise of more than 1 g/dL, and these patients had substantial improvements in their exercise time, Dr. Abraham noted.

A prespecified end point for the two largest of the trials was a combined analysis to assess safety and efficacy measured by the incidence of all-cause death or first hospitalization for heart failure after 1 year of treatment. This combined the results from the 319-patient study described above and the results from a study with 165 patients. The second study randomized 55 patients to placebo, 56 to a weight-based dosage of darbepoetin that was the same as was used in the larger study, and 54 patients to a fixed-dosage regimen of the drug that used 50 mcg every 2 weeks. The results showed no difference between the effects of the weight-based and fixed dosages.

Data for the combined analysis were available for 209 patients who received placebo and 266 who received darbepoetin alfa.

The 1-year incidence of death or hospitalization for heart failure was reduced by 33% in the patients treated with darbepoetin, compared with those who received placebo, a difference that neared statistical significance (P = .064).

Darbepoetin alfa treatment was also associated with trends in improved quality of life and in the patients' global self-assessment.

The incidence of serious adverse events was similar in the placebo and drug-treated arms, and treatment with darbepoetin alfa showed no evidence of any increases in the events that are of particular concern in patients who receive erythropoietin-type drugs, such as hypertension or thrombotic events.

Supplementation with oral iron in patients with anemia is often ineffective in routine practice, because the supplements taste bad and patients stop taking them, which makes an intravenous supplement an attractive alternative, Dr. Anker said.

The results that he reported were collected from 18 heart failure patients with anemia (hemoglobin less than 12.5 g/dL) and 17 patients with no anemia (hemoglobin 12.5–14.5 g/dL) but with iron deficiency as measured by their serum ferritin or transferrin saturation levels. Twelve patients from each of these two subgroups were randomized to treatment with weekly infusions of iron sucrose (Venofer), and the remaining 11 were treated with placebo. Patients were treated for 3 months. The study's primary end point was the change from baseline to the end of the study in peak oxygen consumption.

In the anemic patients, iron supplementation was associated with a significant 204 mL/min greater increase in oxygen consumption over baseline, compared with the placebo group. In the nonanemic patients, iron supplementation did not lead to a notable change in oxygen consumption, compared with the placebo group, Dr. Anker reported.

By other measures, iron supplementation was also linked to improvements in exercise duration and heart failure class. The treatment was also safe, with no difference in adverse event rates between the intervention and control groups.

ELSEVIER GLOBAL MEDICAL NEWS

BARCELONA — Researchers moved a step closer toward proving that correcting the anemia that often occurs in patients with heart failure improves outcomes, with results from three phase II studies that tested two different ways to boost hemoglobin levels.

Reports from two controlled studies that compared darbepoetin alfa with placebo in 475 patients showed that the treatment was safe, that it produced improvements in patients' exercise capacity that were tied to boosts in hemoglobin levels, and that the drug could cut the rate of death or hospitalization for heart failure at a rate that approached statistical significance, Dr. William T. Abraham reported at a joint meeting of the European Society of Cardiology and the World Heart Federation.

And results from the first randomized, observer-blinded test of intravenous iron in 35 patients with heart failure and low iron levels supported the idea that iron repletion is safe and associated with improvement in exercise capacity and heart failure symptoms, Dr. Stefan D. Anker said in a separate report at the meeting.

Anemia is a common complication of heart failure, but just how common depends on how it's defined. In data collected from one recent, large heart failure treatment trial, 30% of women and 16% of men had anemia if it was defined as a serum hemoglobin level of less than 12.5 g/dL. With a more conservative definition of less than 11.5 g/dL, the prevalence was 10% among women and 8% among men, said Dr. Anker, a cardiologist and professor of medicine at Charité University in Berlin.

These hemoglobin levels would not be severe enough to warrant drug interventions if they occurred in otherwise healthy people, in whom the hemoglobin level would have to be less than 10 g/dL to make drug intervention reasonable, Dr. Anker said in an interview. But in the context of heart failure, experts have hypothesized that higher hemoglobin levels might lead to clinically important improvements in exercise capacity and quality of life, and to a significant drop in heart failure hospitalizations.

The two most obvious ways to correct anemia are treatment with an erythropoietin agent and treatment with iron supplementation. These approaches could also be used together.

Three phase II studies of darbepoetin alfa, a long-acting erythropoietin, were recently completed, and results from the two largest of these studies were reported at the meeting. All three studies were sponsored by Amgen, which markets darbepoetin (Aranesp). Dr. Abraham has received research support from Amgen.

One trial involved 319 patients with New York Heart Association class II-IV heart failure and a serum hemoglobin level of 9.0–12.5 g/dL; their average baseline hemoglobin level was 11.35 g/dL. Of the 319 patients, 157 were randomized to receive placebo and 162 received darbepoetin alfa at a starting dosage of 0.75 mcg/kg administered subcutaneously every 2 weeks. The dosage was titrated to produce a rise in hemoglobin of 0.5–1.5 g/dL every 3 weeks and then to maintain a hemoglobin level of 13.0–15.0 g/dL. All patients also received supplemental iron, given as an oral dosage of 200 mg/day.

The primary end point for this study was the change in exercise capacity from baseline after 6 months of treatment, measured as time spent walking on a treadmill.

The regimen produced an average hemoglobin level of 13.5 g/dL in patients who were treated with darbepoetin alfa and no change in the patients treated with placebo.

The change in treadmill-exercise time was an average of 46.5 seconds in placebo patients and 57.3 seconds in the darbepoetin alfa-treated patients, a nonsignificant difference, reported Dr. Abraham, professor of medicine and director of the division of cardiovascular medicine at Ohio State University, Columbus.

However, a post hoc analysis of these data showed a promising and statistically significant link between the rise in serum hemoglobin level and improvements in exercise time (see graph). More than 80% of patients treated with darbepoetin alfa had a “robust response to treatment,” with a hemoglobin rise of more than 1 g/dL, and these patients had substantial improvements in their exercise time, Dr. Abraham noted.

A prespecified end point for the two largest of the trials was a combined analysis to assess safety and efficacy measured by the incidence of all-cause death or first hospitalization for heart failure after 1 year of treatment. This combined the results from the 319-patient study described above and the results from a study with 165 patients. The second study randomized 55 patients to placebo, 56 to a weight-based dosage of darbepoetin that was the same as was used in the larger study, and 54 patients to a fixed-dosage regimen of the drug that used 50 mcg every 2 weeks. The results showed no difference between the effects of the weight-based and fixed dosages.

Data for the combined analysis were available for 209 patients who received placebo and 266 who received darbepoetin alfa.

The 1-year incidence of death or hospitalization for heart failure was reduced by 33% in the patients treated with darbepoetin, compared with those who received placebo, a difference that neared statistical significance (P = .064).

Darbepoetin alfa treatment was also associated with trends in improved quality of life and in the patients' global self-assessment.

The incidence of serious adverse events was similar in the placebo and drug-treated arms, and treatment with darbepoetin alfa showed no evidence of any increases in the events that are of particular concern in patients who receive erythropoietin-type drugs, such as hypertension or thrombotic events.

Supplementation with oral iron in patients with anemia is often ineffective in routine practice, because the supplements taste bad and patients stop taking them, which makes an intravenous supplement an attractive alternative, Dr. Anker said.

The results that he reported were collected from 18 heart failure patients with anemia (hemoglobin less than 12.5 g/dL) and 17 patients with no anemia (hemoglobin 12.5–14.5 g/dL) but with iron deficiency as measured by their serum ferritin or transferrin saturation levels. Twelve patients from each of these two subgroups were randomized to treatment with weekly infusions of iron sucrose (Venofer), and the remaining 11 were treated with placebo. Patients were treated for 3 months. The study's primary end point was the change from baseline to the end of the study in peak oxygen consumption.

In the anemic patients, iron supplementation was associated with a significant 204 mL/min greater increase in oxygen consumption over baseline, compared with the placebo group. In the nonanemic patients, iron supplementation did not lead to a notable change in oxygen consumption, compared with the placebo group, Dr. Anker reported.

By other measures, iron supplementation was also linked to improvements in exercise duration and heart failure class. The treatment was also safe, with no difference in adverse event rates between the intervention and control groups.

ELSEVIER GLOBAL MEDICAL NEWS

BARCELONA — Researchers moved a step closer toward proving that correcting the anemia that often occurs in patients with heart failure improves outcomes, with results from three phase II studies that tested two different ways to boost hemoglobin levels.

Reports from two controlled studies that compared darbepoetin alfa with placebo in 475 patients showed that the treatment was safe, that it produced improvements in patients' exercise capacity that were tied to boosts in hemoglobin levels, and that the drug could cut the rate of death or hospitalization for heart failure at a rate that approached statistical significance, Dr. William T. Abraham reported at a joint meeting of the European Society of Cardiology and the World Heart Federation.

And results from the first randomized, observer-blinded test of intravenous iron in 35 patients with heart failure and low iron levels supported the idea that iron repletion is safe and associated with improvement in exercise capacity and heart failure symptoms, Dr. Stefan D. Anker said in a separate report at the meeting.

Anemia is a common complication of heart failure, but just how common depends on how it's defined. In data collected from one recent, large heart failure treatment trial, 30% of women and 16% of men had anemia if it was defined as a serum hemoglobin level of less than 12.5 g/dL. With a more conservative definition of less than 11.5 g/dL, the prevalence was 10% among women and 8% among men, said Dr. Anker, a cardiologist and professor of medicine at Charité University in Berlin.

These hemoglobin levels would not be severe enough to warrant drug interventions if they occurred in otherwise healthy people, in whom the hemoglobin level would have to be less than 10 g/dL to make drug intervention reasonable, Dr. Anker said in an interview. But in the context of heart failure, experts have hypothesized that higher hemoglobin levels might lead to clinically important improvements in exercise capacity and quality of life, and to a significant drop in heart failure hospitalizations.

The two most obvious ways to correct anemia are treatment with an erythropoietin agent and treatment with iron supplementation. These approaches could also be used together.

Three phase II studies of darbepoetin alfa, a long-acting erythropoietin, were recently completed, and results from the two largest of these studies were reported at the meeting. All three studies were sponsored by Amgen, which markets darbepoetin (Aranesp). Dr. Abraham has received research support from Amgen.

One trial involved 319 patients with New York Heart Association class II-IV heart failure and a serum hemoglobin level of 9.0–12.5 g/dL; their average baseline hemoglobin level was 11.35 g/dL. Of the 319 patients, 157 were randomized to receive placebo and 162 received darbepoetin alfa at a starting dosage of 0.75 mcg/kg administered subcutaneously every 2 weeks. The dosage was titrated to produce a rise in hemoglobin of 0.5–1.5 g/dL every 3 weeks and then to maintain a hemoglobin level of 13.0–15.0 g/dL. All patients also received supplemental iron, given as an oral dosage of 200 mg/day.

The primary end point for this study was the change in exercise capacity from baseline after 6 months of treatment, measured as time spent walking on a treadmill.

The regimen produced an average hemoglobin level of 13.5 g/dL in patients who were treated with darbepoetin alfa and no change in the patients treated with placebo.

The change in treadmill-exercise time was an average of 46.5 seconds in placebo patients and 57.3 seconds in the darbepoetin alfa-treated patients, a nonsignificant difference, reported Dr. Abraham, professor of medicine and director of the division of cardiovascular medicine at Ohio State University, Columbus.

However, a post hoc analysis of these data showed a promising and statistically significant link between the rise in serum hemoglobin level and improvements in exercise time (see graph). More than 80% of patients treated with darbepoetin alfa had a “robust response to treatment,” with a hemoglobin rise of more than 1 g/dL, and these patients had substantial improvements in their exercise time, Dr. Abraham noted.

A prespecified end point for the two largest of the trials was a combined analysis to assess safety and efficacy measured by the incidence of all-cause death or first hospitalization for heart failure after 1 year of treatment. This combined the results from the 319-patient study described above and the results from a study with 165 patients. The second study randomized 55 patients to placebo, 56 to a weight-based dosage of darbepoetin that was the same as was used in the larger study, and 54 patients to a fixed-dosage regimen of the drug that used 50 mcg every 2 weeks. The results showed no difference between the effects of the weight-based and fixed dosages.

Data for the combined analysis were available for 209 patients who received placebo and 266 who received darbepoetin alfa.

The 1-year incidence of death or hospitalization for heart failure was reduced by 33% in the patients treated with darbepoetin, compared with those who received placebo, a difference that neared statistical significance (P = .064).

Darbepoetin alfa treatment was also associated with trends in improved quality of life and in the patients' global self-assessment.

The incidence of serious adverse events was similar in the placebo and drug-treated arms, and treatment with darbepoetin alfa showed no evidence of any increases in the events that are of particular concern in patients who receive erythropoietin-type drugs, such as hypertension or thrombotic events.

Supplementation with oral iron in patients with anemia is often ineffective in routine practice, because the supplements taste bad and patients stop taking them, which makes an intravenous supplement an attractive alternative, Dr. Anker said.

The results that he reported were collected from 18 heart failure patients with anemia (hemoglobin less than 12.5 g/dL) and 17 patients with no anemia (hemoglobin 12.5–14.5 g/dL) but with iron deficiency as measured by their serum ferritin or transferrin saturation levels. Twelve patients from each of these two subgroups were randomized to treatment with weekly infusions of iron sucrose (Venofer), and the remaining 11 were treated with placebo. Patients were treated for 3 months. The study's primary end point was the change from baseline to the end of the study in peak oxygen consumption.

In the anemic patients, iron supplementation was associated with a significant 204 mL/min greater increase in oxygen consumption over baseline, compared with the placebo group. In the nonanemic patients, iron supplementation did not lead to a notable change in oxygen consumption, compared with the placebo group, Dr. Anker reported.

By other measures, iron supplementation was also linked to improvements in exercise duration and heart failure class. The treatment was also safe, with no difference in adverse event rates between the intervention and control groups.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO —Measuring N-terminal-proB-type natriuretic peptide in the emergency department facilitated diagnosis of acute heart failure, shortened visits, and saved money, according to results of IMPROVE-CHF, a multicenter randomized-controlled trial of the use of NT-proBNP-guided strategy in the management of suspected acute heart failure.

“Our economic analysis found that adding this test to physician judgment reduced the duration of the emergency department visit from an average of 6.3 hours to an average of 5.6 hours,” Dr. Gordon W. Moe reported at the annual scientific sessions of the American Heart Association.

“In addition, it reduced the number of patients rehospitalized within 60 days from 51 to 33 and reduced costs in 2005 U.S. dollars from $5,592 to $4,631 per patient overall, a savings of $961 per patient,” Dr. Moe said.

The IMPROVE-CHF study included 501 patients who presented to seven Canadian emergency departments with dyspnea. NT-proBNP samples were taken in all patients, but in only about half were the treating physicians made aware of the results. In the other half of patients, physicians utilized standard clinical tools to determine a diagnosis.

Patients were followed for 60 days to determine whether knowledge of NT-proBNP values improved the management of patients with suspected acute heart failure in a publicly funded, universal-access health care setting.

Although the amount of time spent in the ED was significantly reduced, the number of ICU admissions, median duration of ICU stay, and the number of patients requiring hospitalization after their ED visit did not differ between the NT-proBNP group and the usual-care group. By 60 days, 23% of patients enrolled had died or were rehospitalized, with no difference between groups.

Discussant Dr. Margaret M. Redford of the Mayo Clinic in Rochester, Minn., noted that the researchers were not clear on whether the cost savings were caused by more efficient treatment of patients or to less use of other diagnostic testing. It was also unclear whether the test was most helpful in making a diagnosis of heart failure or in excluding heart failure.

She also noted that the setting for IMPROVE-CHF—in Canada, where there is a single-payer system and carefully controlled costs—is both a strength and a limitation of the trial. “In this system costs are already carefully controlled, making it a rigorous testing ground for cost-saving measure … but we cannot assume the savings observed in the Canadian system would necessarily be observed in other health care systems.”

CHICAGO —Measuring N-terminal-proB-type natriuretic peptide in the emergency department facilitated diagnosis of acute heart failure, shortened visits, and saved money, according to results of IMPROVE-CHF, a multicenter randomized-controlled trial of the use of NT-proBNP-guided strategy in the management of suspected acute heart failure.

“Our economic analysis found that adding this test to physician judgment reduced the duration of the emergency department visit from an average of 6.3 hours to an average of 5.6 hours,” Dr. Gordon W. Moe reported at the annual scientific sessions of the American Heart Association.

“In addition, it reduced the number of patients rehospitalized within 60 days from 51 to 33 and reduced costs in 2005 U.S. dollars from $5,592 to $4,631 per patient overall, a savings of $961 per patient,” Dr. Moe said.

The IMPROVE-CHF study included 501 patients who presented to seven Canadian emergency departments with dyspnea. NT-proBNP samples were taken in all patients, but in only about half were the treating physicians made aware of the results. In the other half of patients, physicians utilized standard clinical tools to determine a diagnosis.

Patients were followed for 60 days to determine whether knowledge of NT-proBNP values improved the management of patients with suspected acute heart failure in a publicly funded, universal-access health care setting.

Although the amount of time spent in the ED was significantly reduced, the number of ICU admissions, median duration of ICU stay, and the number of patients requiring hospitalization after their ED visit did not differ between the NT-proBNP group and the usual-care group. By 60 days, 23% of patients enrolled had died or were rehospitalized, with no difference between groups.

Discussant Dr. Margaret M. Redford of the Mayo Clinic in Rochester, Minn., noted that the researchers were not clear on whether the cost savings were caused by more efficient treatment of patients or to less use of other diagnostic testing. It was also unclear whether the test was most helpful in making a diagnosis of heart failure or in excluding heart failure.

She also noted that the setting for IMPROVE-CHF—in Canada, where there is a single-payer system and carefully controlled costs—is both a strength and a limitation of the trial. “In this system costs are already carefully controlled, making it a rigorous testing ground for cost-saving measure … but we cannot assume the savings observed in the Canadian system would necessarily be observed in other health care systems.”

CHICAGO —Measuring N-terminal-proB-type natriuretic peptide in the emergency department facilitated diagnosis of acute heart failure, shortened visits, and saved money, according to results of IMPROVE-CHF, a multicenter randomized-controlled trial of the use of NT-proBNP-guided strategy in the management of suspected acute heart failure.

“Our economic analysis found that adding this test to physician judgment reduced the duration of the emergency department visit from an average of 6.3 hours to an average of 5.6 hours,” Dr. Gordon W. Moe reported at the annual scientific sessions of the American Heart Association.

“In addition, it reduced the number of patients rehospitalized within 60 days from 51 to 33 and reduced costs in 2005 U.S. dollars from $5,592 to $4,631 per patient overall, a savings of $961 per patient,” Dr. Moe said.

The IMPROVE-CHF study included 501 patients who presented to seven Canadian emergency departments with dyspnea. NT-proBNP samples were taken in all patients, but in only about half were the treating physicians made aware of the results. In the other half of patients, physicians utilized standard clinical tools to determine a diagnosis.

Patients were followed for 60 days to determine whether knowledge of NT-proBNP values improved the management of patients with suspected acute heart failure in a publicly funded, universal-access health care setting.

Although the amount of time spent in the ED was significantly reduced, the number of ICU admissions, median duration of ICU stay, and the number of patients requiring hospitalization after their ED visit did not differ between the NT-proBNP group and the usual-care group. By 60 days, 23% of patients enrolled had died or were rehospitalized, with no difference between groups.

Discussant Dr. Margaret M. Redford of the Mayo Clinic in Rochester, Minn., noted that the researchers were not clear on whether the cost savings were caused by more efficient treatment of patients or to less use of other diagnostic testing. It was also unclear whether the test was most helpful in making a diagnosis of heart failure or in excluding heart failure.

She also noted that the setting for IMPROVE-CHF—in Canada, where there is a single-payer system and carefully controlled costs—is both a strength and a limitation of the trial. “In this system costs are already carefully controlled, making it a rigorous testing ground for cost-saving measure … but we cannot assume the savings observed in the Canadian system would necessarily be observed in other health care systems.”

SEATTLE — The Heart Failure Society of America introduced at its annual meeting its 2006 Comprehensive Heart Failure Practice Guidelines, which updates its original 1999 guidelines.

“There wasn't much data available then. It was a good start, but this is a completely different document,” said Dr. JoAnn Lindenfeld, current chair of the heart failure practice guideline committee and director of heart transplantation at the University of Colorado Health Sciences Center, Denver.

The Heart Failure Society of America (HFSA) guidelines are more comprehensive than two other sets of heart failure guidelines put out separately in 2005 by the European Society of Cardiology (ESC) and jointly by the American Heart Association and American College of Cardiology (AHA/ACC), she said.

The AHA/ACC recommendations don't address acute heart failure, and the ESC created separate sets of guidelines for acute and chronic heart failure. The HFSA guidelines include both.

“I think the ESC guidelines go further in [discussion of] subpopulations,” Dr. Kirkwood F. Adams Jr. commented in a discussion session on the HFSA guidelines. “Heart failure [encompasses] about 18 different populations. I think as people look back 100 years from now, they'll be perhaps laughing that we had something called heart failure guidelines when really there are so many different patient varieties.”

One of the values of the HFSA's comprehensive approach is that the guidelines focus attention on the enormous public health problem that heart failure presents, causing more than 1 million U.S. hospitalizations per year, added Dr. Adams, who cochaired the guidelines committee with Dr. Lindenfeld and is director of the heart failure program at the University of North Carolina, Chapel Hill. “It's good to push recognition” of the problem among both specialists and primary care physicians, who manage 80% of patients with heart failure.

The HFSA guidelines comprise 16 sections that include acute or chronic heart failure, disease management, heart failure in special populations, hypertension in heart failure, heart failure with preserved ejection fraction, and more. The recommendations come in four strengths:

▸ Is recommended—part of routine care, with very few exceptions.

▸ Should be considered—the majority of patients should receive the intervention.

▸ May be considered—individualize the therapy to the patient.

▸ Is not recommended—don't use the intervention.

The guidelines also present the level of evidence for recommendations, following routine models for rating evidence with one exception: One randomized trial could constitute the highest level of evidence (A). “That's controversial,” Dr. Adams said.

In some categories, recommendations of the highest level are not based on the highest level of evidence. Although the guidelines on acute decompensated heart failure include many interventions that are “recommended,” none of these are based on level A evidence, for example, Dr. Lindenfeld said.

“This points out how far we have to go in the data and studies of acute decompensated heart failure,” she said.

The HFSA committee elected not to present majority and minority opinions on its recommendations, as some other guidelines do. “I think majority/minority opinions are useless. You go to the guidelines to get a recommendation,” Dr. Adams said.

The HFSA committee plans to update the guidelines yearly. Topics not covered in the current guidelines that may be included in future versions include genetic screening and testing of patients with heart failure, the timing of altering diuretic therapy, and more guidance on implantable devices.

Clinicians can request a free copy of the pocket guidelines or request pricing for multiple copies by contacting info@hfsa.orgwww.heartfailureguideline.com

SEATTLE — The Heart Failure Society of America introduced at its annual meeting its 2006 Comprehensive Heart Failure Practice Guidelines, which updates its original 1999 guidelines.

“There wasn't much data available then. It was a good start, but this is a completely different document,” said Dr. JoAnn Lindenfeld, current chair of the heart failure practice guideline committee and director of heart transplantation at the University of Colorado Health Sciences Center, Denver.

The Heart Failure Society of America (HFSA) guidelines are more comprehensive than two other sets of heart failure guidelines put out separately in 2005 by the European Society of Cardiology (ESC) and jointly by the American Heart Association and American College of Cardiology (AHA/ACC), she said.

The AHA/ACC recommendations don't address acute heart failure, and the ESC created separate sets of guidelines for acute and chronic heart failure. The HFSA guidelines include both.

“I think the ESC guidelines go further in [discussion of] subpopulations,” Dr. Kirkwood F. Adams Jr. commented in a discussion session on the HFSA guidelines. “Heart failure [encompasses] about 18 different populations. I think as people look back 100 years from now, they'll be perhaps laughing that we had something called heart failure guidelines when really there are so many different patient varieties.”

One of the values of the HFSA's comprehensive approach is that the guidelines focus attention on the enormous public health problem that heart failure presents, causing more than 1 million U.S. hospitalizations per year, added Dr. Adams, who cochaired the guidelines committee with Dr. Lindenfeld and is director of the heart failure program at the University of North Carolina, Chapel Hill. “It's good to push recognition” of the problem among both specialists and primary care physicians, who manage 80% of patients with heart failure.

The HFSA guidelines comprise 16 sections that include acute or chronic heart failure, disease management, heart failure in special populations, hypertension in heart failure, heart failure with preserved ejection fraction, and more. The recommendations come in four strengths:

▸ Is recommended—part of routine care, with very few exceptions.

▸ Should be considered—the majority of patients should receive the intervention.

▸ May be considered—individualize the therapy to the patient.

▸ Is not recommended—don't use the intervention.

The guidelines also present the level of evidence for recommendations, following routine models for rating evidence with one exception: One randomized trial could constitute the highest level of evidence (A). “That's controversial,” Dr. Adams said.

In some categories, recommendations of the highest level are not based on the highest level of evidence. Although the guidelines on acute decompensated heart failure include many interventions that are “recommended,” none of these are based on level A evidence, for example, Dr. Lindenfeld said.

“This points out how far we have to go in the data and studies of acute decompensated heart failure,” she said.

The HFSA committee elected not to present majority and minority opinions on its recommendations, as some other guidelines do. “I think majority/minority opinions are useless. You go to the guidelines to get a recommendation,” Dr. Adams said.

The HFSA committee plans to update the guidelines yearly. Topics not covered in the current guidelines that may be included in future versions include genetic screening and testing of patients with heart failure, the timing of altering diuretic therapy, and more guidance on implantable devices.

Clinicians can request a free copy of the pocket guidelines or request pricing for multiple copies by contacting info@hfsa.orgwww.heartfailureguideline.com

SEATTLE — The Heart Failure Society of America introduced at its annual meeting its 2006 Comprehensive Heart Failure Practice Guidelines, which updates its original 1999 guidelines.

“There wasn't much data available then. It was a good start, but this is a completely different document,” said Dr. JoAnn Lindenfeld, current chair of the heart failure practice guideline committee and director of heart transplantation at the University of Colorado Health Sciences Center, Denver.

The Heart Failure Society of America (HFSA) guidelines are more comprehensive than two other sets of heart failure guidelines put out separately in 2005 by the European Society of Cardiology (ESC) and jointly by the American Heart Association and American College of Cardiology (AHA/ACC), she said.

The AHA/ACC recommendations don't address acute heart failure, and the ESC created separate sets of guidelines for acute and chronic heart failure. The HFSA guidelines include both.

“I think the ESC guidelines go further in [discussion of] subpopulations,” Dr. Kirkwood F. Adams Jr. commented in a discussion session on the HFSA guidelines. “Heart failure [encompasses] about 18 different populations. I think as people look back 100 years from now, they'll be perhaps laughing that we had something called heart failure guidelines when really there are so many different patient varieties.”

One of the values of the HFSA's comprehensive approach is that the guidelines focus attention on the enormous public health problem that heart failure presents, causing more than 1 million U.S. hospitalizations per year, added Dr. Adams, who cochaired the guidelines committee with Dr. Lindenfeld and is director of the heart failure program at the University of North Carolina, Chapel Hill. “It's good to push recognition” of the problem among both specialists and primary care physicians, who manage 80% of patients with heart failure.

The HFSA guidelines comprise 16 sections that include acute or chronic heart failure, disease management, heart failure in special populations, hypertension in heart failure, heart failure with preserved ejection fraction, and more. The recommendations come in four strengths:

▸ Is recommended—part of routine care, with very few exceptions.

▸ Should be considered—the majority of patients should receive the intervention.

▸ May be considered—individualize the therapy to the patient.

▸ Is not recommended—don't use the intervention.

The guidelines also present the level of evidence for recommendations, following routine models for rating evidence with one exception: One randomized trial could constitute the highest level of evidence (A). “That's controversial,” Dr. Adams said.

In some categories, recommendations of the highest level are not based on the highest level of evidence. Although the guidelines on acute decompensated heart failure include many interventions that are “recommended,” none of these are based on level A evidence, for example, Dr. Lindenfeld said.

“This points out how far we have to go in the data and studies of acute decompensated heart failure,” she said.

The HFSA committee elected not to present majority and minority opinions on its recommendations, as some other guidelines do. “I think majority/minority opinions are useless. You go to the guidelines to get a recommendation,” Dr. Adams said.

The HFSA committee plans to update the guidelines yearly. Topics not covered in the current guidelines that may be included in future versions include genetic screening and testing of patients with heart failure, the timing of altering diuretic therapy, and more guidance on implantable devices.

Clinicians can request a free copy of the pocket guidelines or request pricing for multiple copies by contacting info@hfsa.orgwww.heartfailureguideline.com