Heart Failure

ATLANTA — A novel heart device safely cut the severity of functional mitral regurgitation and boosted patient survival compared with conventional mitral valve repair in a randomized, multicenter trial of 165 patients.

The Coapsys device is a durable, coated cord placed in a precise location through the center of a patient's left ventricle and held in place by two anchoring pads placed externally on opposite sides of the ventricle. Tension that the cord exerts on the pads reshapes the ventricle as well as the mitral annulus. The latter effect helps to partially correct the functional mitral regurgitation.

The study results “indicate that patients with functional mitral regurgitation requiring revascularization treated with ventricular reshaping rather than standard surgery had improved survival and significant reduction of major adverse outcomes,” Dr. Eugene A. Grossi said at the meeting.

“By reshaping the ventricle, we cut the mortality to half of what was expected,” a result that was “surprising,” said Dr. Grossi, professor of cardiothoracic surgery at New York University. The results helped confirm the suspicion of many cardiologists and heart surgeons that functional mitral regurgitation is largely a disease of ventricular shape. The findings also indicate that “by treating the ventricle we'll be able to help these patients in addition to fixing” their mitral regurgitation.

“It's unfortunate that we don't have more tools to influence the ventricle,” said Dr. Steven F. Bolling, professor of surgery and director of the mitral valve clinic at the University of Michigan, Ann Arbor.

The Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve (RESTOR-MV) trial included 81 patients who received the Coapsys device plus coronary artery bypass grafting (CABG), and a control group of 75 patients treated by conventional mitral valve repair plus CABG and 9 patients treated with CABG alone. The device is placed on beating hearts without need for cardiopulmonary bypass. No patient had a perioperative, device-related complication. During 3-year follow-up, the incidence of all postoperative adverse events was 54% lower in patients treated with the Coapsys device compared with the controls, and the incidence of major postoperative adverse events—death, stroke, myocardial infarction, or need for a redo valve intervention—was 62% lower in the patients who received the Coapsys device. Both differences were statistically significant.

Overall mortality was 15% in the Coapsys group and 30% in the control arm. In an analysis that adjusted for any baseline differences in patients, treatment with the Coapsys device cut overall mortality by 58% compared with all the control patients, a statistically significant difference. Survival was very similar during the first 3 months after surgery and then began to steadily diverge. “Mortality in the control arm was about the same as in any other trial of mitral valve repair in this kind of patient,” Dr. Grossi said.

The average severity of mitral regurgitation in the 81 patients treated with the device fell from 2.40 (on a scale of 0–4) at baseline to an average of 1.25 24 months after surgery. Among the 75 control patients treated with mitral valve repair and CABG, regurgitation severity fell from an average score of 2.54 at baseline to 0.35 24 months after surgery. Although the control patients had a better average improvement in their regurgitation, the Coapsys patients had a significant improvement in their level compared with their baseline status. “We didn't do as good a job correcting the mitral regurgitation as standard mitral annuloplasty, but [the device] is a way to also treat the ventricle, and we all know that this is a ventricular disease,” Dr. Grossi said.

Two years after surgery, the New York Heart Association heart failure rating of patients fell by at least one level in 79% of the patients treated with the Coapsys device and in 72% of the control patients, a difference that was not statistically significant. The average NYHA class heart failure level of patients entering surgery was 2.5. The average age of all study patients was 64 years; three-quarters were men.

The Coapsys device was easily implanted with a handheld echocardiography device for guidance, said Dr. Grossi, who placed the device in 40 patients.

Despite the promising results, future development of the device is unclear. Myocor, which developed the Coapsys device, went out of business while the study was in progress in 2008. Its intellectual property, including the concept behind the Coapsys device, was purchased by Edwards Lifesciences. A spokeswoman for Edwards declined to discuss plans for further development.

“Now knowing that we can take this approach to treating patients and help them with something as concrete as a mortality benefit, I think we'll see a lot of equivalent devices treating the ventricle and not the mitral valve alone,” said Dr. Grossi, who had no disclosures relevant to the study. The study was sponsored by Myocor.

To view a video interview of Dr. Grossi, go to youtube.com

My Take

Study Leaves Questions Unanswered

Pure functional mitral regurgitation is probably responsible for about a third of all mitral regurgitation cases. We can identify functional mitral regurgitation by echocardiography. On echo, the mitral leaflets look normal but the valve has a central regurgitation because the annulus is distorted secondary to enlargement of the ventricle.

The Coapsys device is intended for patients at a relatively early stage of ventricular dilatation and moderate mitral regurgitation. One limitation of the trial is that it relied on current grading methods for mitral regurgitation severity, which are very imprecise.

The RESTOR-MV trial was underpowered. It serves as a demonstration study, and shows that the device has utility in some patients, but the study was not large enough or long enough to produce meaningful conclusions. It leaves unanswered several big questions, such as what happens to the patients' heart failure long term, and what occurs if patients require later heart surgery. How much scarring does the device cause, and will it allow subsequent valve repair?

In don't think that surgeons will favor placing such a device. It's imprecise. It reshapes the ventricle, but the heart ends up distorted and probably undergoes pericardial scarring. Questions remain about the device's impact on long-term ventricular and mitral valve function.

ATLANTA — A novel heart device safely cut the severity of functional mitral regurgitation and boosted patient survival compared with conventional mitral valve repair in a randomized, multicenter trial of 165 patients.

The Coapsys device is a durable, coated cord placed in a precise location through the center of a patient's left ventricle and held in place by two anchoring pads placed externally on opposite sides of the ventricle. Tension that the cord exerts on the pads reshapes the ventricle as well as the mitral annulus. The latter effect helps to partially correct the functional mitral regurgitation.

The study results “indicate that patients with functional mitral regurgitation requiring revascularization treated with ventricular reshaping rather than standard surgery had improved survival and significant reduction of major adverse outcomes,” Dr. Eugene A. Grossi said at the meeting.

“By reshaping the ventricle, we cut the mortality to half of what was expected,” a result that was “surprising,” said Dr. Grossi, professor of cardiothoracic surgery at New York University. The results helped confirm the suspicion of many cardiologists and heart surgeons that functional mitral regurgitation is largely a disease of ventricular shape. The findings also indicate that “by treating the ventricle we'll be able to help these patients in addition to fixing” their mitral regurgitation.

“It's unfortunate that we don't have more tools to influence the ventricle,” said Dr. Steven F. Bolling, professor of surgery and director of the mitral valve clinic at the University of Michigan, Ann Arbor.

The Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve (RESTOR-MV) trial included 81 patients who received the Coapsys device plus coronary artery bypass grafting (CABG), and a control group of 75 patients treated by conventional mitral valve repair plus CABG and 9 patients treated with CABG alone. The device is placed on beating hearts without need for cardiopulmonary bypass. No patient had a perioperative, device-related complication. During 3-year follow-up, the incidence of all postoperative adverse events was 54% lower in patients treated with the Coapsys device compared with the controls, and the incidence of major postoperative adverse events—death, stroke, myocardial infarction, or need for a redo valve intervention—was 62% lower in the patients who received the Coapsys device. Both differences were statistically significant.

Overall mortality was 15% in the Coapsys group and 30% in the control arm. In an analysis that adjusted for any baseline differences in patients, treatment with the Coapsys device cut overall mortality by 58% compared with all the control patients, a statistically significant difference. Survival was very similar during the first 3 months after surgery and then began to steadily diverge. “Mortality in the control arm was about the same as in any other trial of mitral valve repair in this kind of patient,” Dr. Grossi said.

The average severity of mitral regurgitation in the 81 patients treated with the device fell from 2.40 (on a scale of 0–4) at baseline to an average of 1.25 24 months after surgery. Among the 75 control patients treated with mitral valve repair and CABG, regurgitation severity fell from an average score of 2.54 at baseline to 0.35 24 months after surgery. Although the control patients had a better average improvement in their regurgitation, the Coapsys patients had a significant improvement in their level compared with their baseline status. “We didn't do as good a job correcting the mitral regurgitation as standard mitral annuloplasty, but [the device] is a way to also treat the ventricle, and we all know that this is a ventricular disease,” Dr. Grossi said.

Two years after surgery, the New York Heart Association heart failure rating of patients fell by at least one level in 79% of the patients treated with the Coapsys device and in 72% of the control patients, a difference that was not statistically significant. The average NYHA class heart failure level of patients entering surgery was 2.5. The average age of all study patients was 64 years; three-quarters were men.

The Coapsys device was easily implanted with a handheld echocardiography device for guidance, said Dr. Grossi, who placed the device in 40 patients.

Despite the promising results, future development of the device is unclear. Myocor, which developed the Coapsys device, went out of business while the study was in progress in 2008. Its intellectual property, including the concept behind the Coapsys device, was purchased by Edwards Lifesciences. A spokeswoman for Edwards declined to discuss plans for further development.

“Now knowing that we can take this approach to treating patients and help them with something as concrete as a mortality benefit, I think we'll see a lot of equivalent devices treating the ventricle and not the mitral valve alone,” said Dr. Grossi, who had no disclosures relevant to the study. The study was sponsored by Myocor.

To view a video interview of Dr. Grossi, go to youtube.com

My Take

Study Leaves Questions Unanswered

Pure functional mitral regurgitation is probably responsible for about a third of all mitral regurgitation cases. We can identify functional mitral regurgitation by echocardiography. On echo, the mitral leaflets look normal but the valve has a central regurgitation because the annulus is distorted secondary to enlargement of the ventricle.

The Coapsys device is intended for patients at a relatively early stage of ventricular dilatation and moderate mitral regurgitation. One limitation of the trial is that it relied on current grading methods for mitral regurgitation severity, which are very imprecise.

The RESTOR-MV trial was underpowered. It serves as a demonstration study, and shows that the device has utility in some patients, but the study was not large enough or long enough to produce meaningful conclusions. It leaves unanswered several big questions, such as what happens to the patients' heart failure long term, and what occurs if patients require later heart surgery. How much scarring does the device cause, and will it allow subsequent valve repair?

In don't think that surgeons will favor placing such a device. It's imprecise. It reshapes the ventricle, but the heart ends up distorted and probably undergoes pericardial scarring. Questions remain about the device's impact on long-term ventricular and mitral valve function.

ATLANTA — A novel heart device safely cut the severity of functional mitral regurgitation and boosted patient survival compared with conventional mitral valve repair in a randomized, multicenter trial of 165 patients.

The Coapsys device is a durable, coated cord placed in a precise location through the center of a patient's left ventricle and held in place by two anchoring pads placed externally on opposite sides of the ventricle. Tension that the cord exerts on the pads reshapes the ventricle as well as the mitral annulus. The latter effect helps to partially correct the functional mitral regurgitation.

The study results “indicate that patients with functional mitral regurgitation requiring revascularization treated with ventricular reshaping rather than standard surgery had improved survival and significant reduction of major adverse outcomes,” Dr. Eugene A. Grossi said at the meeting.

“By reshaping the ventricle, we cut the mortality to half of what was expected,” a result that was “surprising,” said Dr. Grossi, professor of cardiothoracic surgery at New York University. The results helped confirm the suspicion of many cardiologists and heart surgeons that functional mitral regurgitation is largely a disease of ventricular shape. The findings also indicate that “by treating the ventricle we'll be able to help these patients in addition to fixing” their mitral regurgitation.

“It's unfortunate that we don't have more tools to influence the ventricle,” said Dr. Steven F. Bolling, professor of surgery and director of the mitral valve clinic at the University of Michigan, Ann Arbor.

The Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve (RESTOR-MV) trial included 81 patients who received the Coapsys device plus coronary artery bypass grafting (CABG), and a control group of 75 patients treated by conventional mitral valve repair plus CABG and 9 patients treated with CABG alone. The device is placed on beating hearts without need for cardiopulmonary bypass. No patient had a perioperative, device-related complication. During 3-year follow-up, the incidence of all postoperative adverse events was 54% lower in patients treated with the Coapsys device compared with the controls, and the incidence of major postoperative adverse events—death, stroke, myocardial infarction, or need for a redo valve intervention—was 62% lower in the patients who received the Coapsys device. Both differences were statistically significant.

Overall mortality was 15% in the Coapsys group and 30% in the control arm. In an analysis that adjusted for any baseline differences in patients, treatment with the Coapsys device cut overall mortality by 58% compared with all the control patients, a statistically significant difference. Survival was very similar during the first 3 months after surgery and then began to steadily diverge. “Mortality in the control arm was about the same as in any other trial of mitral valve repair in this kind of patient,” Dr. Grossi said.

The average severity of mitral regurgitation in the 81 patients treated with the device fell from 2.40 (on a scale of 0–4) at baseline to an average of 1.25 24 months after surgery. Among the 75 control patients treated with mitral valve repair and CABG, regurgitation severity fell from an average score of 2.54 at baseline to 0.35 24 months after surgery. Although the control patients had a better average improvement in their regurgitation, the Coapsys patients had a significant improvement in their level compared with their baseline status. “We didn't do as good a job correcting the mitral regurgitation as standard mitral annuloplasty, but [the device] is a way to also treat the ventricle, and we all know that this is a ventricular disease,” Dr. Grossi said.

Two years after surgery, the New York Heart Association heart failure rating of patients fell by at least one level in 79% of the patients treated with the Coapsys device and in 72% of the control patients, a difference that was not statistically significant. The average NYHA class heart failure level of patients entering surgery was 2.5. The average age of all study patients was 64 years; three-quarters were men.

The Coapsys device was easily implanted with a handheld echocardiography device for guidance, said Dr. Grossi, who placed the device in 40 patients.

Despite the promising results, future development of the device is unclear. Myocor, which developed the Coapsys device, went out of business while the study was in progress in 2008. Its intellectual property, including the concept behind the Coapsys device, was purchased by Edwards Lifesciences. A spokeswoman for Edwards declined to discuss plans for further development.

“Now knowing that we can take this approach to treating patients and help them with something as concrete as a mortality benefit, I think we'll see a lot of equivalent devices treating the ventricle and not the mitral valve alone,” said Dr. Grossi, who had no disclosures relevant to the study. The study was sponsored by Myocor.

To view a video interview of Dr. Grossi, go to youtube.com

My Take

Study Leaves Questions Unanswered

Pure functional mitral regurgitation is probably responsible for about a third of all mitral regurgitation cases. We can identify functional mitral regurgitation by echocardiography. On echo, the mitral leaflets look normal but the valve has a central regurgitation because the annulus is distorted secondary to enlargement of the ventricle.

The Coapsys device is intended for patients at a relatively early stage of ventricular dilatation and moderate mitral regurgitation. One limitation of the trial is that it relied on current grading methods for mitral regurgitation severity, which are very imprecise.

The RESTOR-MV trial was underpowered. It serves as a demonstration study, and shows that the device has utility in some patients, but the study was not large enough or long enough to produce meaningful conclusions. It leaves unanswered several big questions, such as what happens to the patients' heart failure long term, and what occurs if patients require later heart surgery. How much scarring does the device cause, and will it allow subsequent valve repair?

In don't think that surgeons will favor placing such a device. It's imprecise. It reshapes the ventricle, but the heart ends up distorted and probably undergoes pericardial scarring. Questions remain about the device's impact on long-term ventricular and mitral valve function.

Heart failure patients discharged from hospitals with high levels of early physician evaluation are less likely to be readmitted to the hospital within 30 days, according to an analysis of records on more than 30,000 heart failure patients from 225 hospitals.

However, most heart failure patients do not visit a physician within 7 days of discharge.

The analysis of data from the American Heart Association's Get With The Guidelines–Heart Failure (GWTG–HF) Registry linked to Medicare billing records, which looked at hospital-level rates of early outpatient follow-up after discharge during 2003–2006, found that the median rate of follow-up within 7 days of discharge was 38%.

“For patients with heart failure, the transition from inpatient to outpatient care can be an especially vulnerable period because of the age of the patients, complex medical regimens, the large number of comorbid conditions, and the multiple clinicians who may be involved,” wrote Dr. Adrian F. Hernandez of Duke University, Durham, N.C., and his coauthors. “Our findings highlight a need for improvement and greater uniformity in coordination of care from inpatient to outpatient settings.”

Overall, about 21% of heart failure patients were readmitted to the hospital within 30 days of discharge. Patients in hospitals with higher rates of early follow-up had a lower risk of readmission, the study found (JAMA 2010;303:1716–22).

After adjustment for case mix, admission laboratory results, provision of discharge instructions, and length of stay, the risk-adjusted hazard of 30-day readmission was 15% lower in the hospitals with higher rates of early follow-up, the study found. Whereas 20% of patients whose initial hospital stay took place in a hospital with the highest rates of early follow-up were readmitted, 23% of patients in the hospitals with the lowest follow-up rates were readmitted, a significant difference.

Still, the authors only found differences in rehospitalization rates in the hospitals that ranked in the lowest quartile of posthospitalization follow-up; rates at the other 75% of hospitals were similar. They also found some racial differences: The proportion of black patients was “markedly higher” among hospitals with the lowest rates of early follow-up.

They also found that patients discharged from hospitals with the highest rates of early follow-up by a cardiologist had lower risk of 30-day mortality, which they noted is consistent with other studies of cardiology care for heart failure.

Most follow-up during the transitional period, especially during the first week, is handled by general internists, the study authors found. More than two-thirds of patients hospitalized for heart failure are evaluated by a cardiologist during their inpatient stays, but fewer than 10% see a cardiologist within 7 days of hospital discharge. By 21 days post discharge, 76% of patients had been seen by any physician, and 25% by a cardiologist.

However, neither early follow-up with a cardiologist nor continuity of care from the same physician seen during the hospitalization was a significant predictor of 30-day readmission, they wrote.

Documentation of discharge instructions, which many physicians presume helps to ensure early follow-up and better outcomes, also was not associated with lower readmission rates. “This finding raises the possibility that discharge instructions are becoming rote processes that do not adequately address elements of care that ensure a safe transition,” the authors wrote.

The study provides evidence in support of guidelines recommending the use of postdischarge systems of care, the authors said. “Achieving early follow-up may be difficult for some physician practices, but models of care that include nurse practitioners or physician assistants under physician supervision may result in increased access to and timeliness of care.”

Reporting the results at the annual scientific session of the American College of Cardiology in Atlanta in March, Dr. Hernandez said that ensuring that patients hospitalized for heart failure are evaluated by a physician within 7 days after discharge is emerging as a potential new target for hospital quality improvement.

The problem of unplanned early readmissions is a hot button issue that has drawn considerable attention from health policy makers. Roughly 20% of Medicare beneficiaries are readmitted within 30 days of hospitalization. Nearly 90% of these readmissions are unplanned and potentially preventable. These readmissions account for $20 billion annually in Medicare hospital payments. And heart failure is the No. 1 cause of readmission within 30 days, noted Dr. Hernandez of the Duke Clinical Research Institute, Durham, N.C.

One audience member serving on a panel advising the Center for Medicare and Medicaid Services said “these are just the kind of data we've been looking for” in order to make recommendations to the agency regarding new hospital performance standards. However, she questioned whether a physician was necessarily the right person to do the early follow-up evaluation. Fine-tuning of outpatient heart failure management might be better done by a dedicated nurse practitioner or physician assistant.

The study was supported by grants from the American Heart Association, GlaxoSmithKline, Medtronic, and the Agency for Healthcare Research and Quality. Dr. Hernandez reported financial relationships with Johnson & Johnson, Medtronic, Merck, Novartis, and AstraZeneca. Other authors reported a variety of financial support from drug manufacturers, other health care companies, and nonprofit organizations.

Bruce Jancin, reporting from the annual scientific sessions of the ACC in Atlanta, contributed to this article.

Heart failure patients discharged from hospitals with high levels of early physician evaluation are less likely to be readmitted to the hospital within 30 days, according to an analysis of records on more than 30,000 heart failure patients from 225 hospitals.

However, most heart failure patients do not visit a physician within 7 days of discharge.

The analysis of data from the American Heart Association's Get With The Guidelines–Heart Failure (GWTG–HF) Registry linked to Medicare billing records, which looked at hospital-level rates of early outpatient follow-up after discharge during 2003–2006, found that the median rate of follow-up within 7 days of discharge was 38%.

“For patients with heart failure, the transition from inpatient to outpatient care can be an especially vulnerable period because of the age of the patients, complex medical regimens, the large number of comorbid conditions, and the multiple clinicians who may be involved,” wrote Dr. Adrian F. Hernandez of Duke University, Durham, N.C., and his coauthors. “Our findings highlight a need for improvement and greater uniformity in coordination of care from inpatient to outpatient settings.”

Overall, about 21% of heart failure patients were readmitted to the hospital within 30 days of discharge. Patients in hospitals with higher rates of early follow-up had a lower risk of readmission, the study found (JAMA 2010;303:1716–22).

After adjustment for case mix, admission laboratory results, provision of discharge instructions, and length of stay, the risk-adjusted hazard of 30-day readmission was 15% lower in the hospitals with higher rates of early follow-up, the study found. Whereas 20% of patients whose initial hospital stay took place in a hospital with the highest rates of early follow-up were readmitted, 23% of patients in the hospitals with the lowest follow-up rates were readmitted, a significant difference.

Still, the authors only found differences in rehospitalization rates in the hospitals that ranked in the lowest quartile of posthospitalization follow-up; rates at the other 75% of hospitals were similar. They also found some racial differences: The proportion of black patients was “markedly higher” among hospitals with the lowest rates of early follow-up.

They also found that patients discharged from hospitals with the highest rates of early follow-up by a cardiologist had lower risk of 30-day mortality, which they noted is consistent with other studies of cardiology care for heart failure.

Most follow-up during the transitional period, especially during the first week, is handled by general internists, the study authors found. More than two-thirds of patients hospitalized for heart failure are evaluated by a cardiologist during their inpatient stays, but fewer than 10% see a cardiologist within 7 days of hospital discharge. By 21 days post discharge, 76% of patients had been seen by any physician, and 25% by a cardiologist.

However, neither early follow-up with a cardiologist nor continuity of care from the same physician seen during the hospitalization was a significant predictor of 30-day readmission, they wrote.

Documentation of discharge instructions, which many physicians presume helps to ensure early follow-up and better outcomes, also was not associated with lower readmission rates. “This finding raises the possibility that discharge instructions are becoming rote processes that do not adequately address elements of care that ensure a safe transition,” the authors wrote.

The study provides evidence in support of guidelines recommending the use of postdischarge systems of care, the authors said. “Achieving early follow-up may be difficult for some physician practices, but models of care that include nurse practitioners or physician assistants under physician supervision may result in increased access to and timeliness of care.”

Reporting the results at the annual scientific session of the American College of Cardiology in Atlanta in March, Dr. Hernandez said that ensuring that patients hospitalized for heart failure are evaluated by a physician within 7 days after discharge is emerging as a potential new target for hospital quality improvement.

The problem of unplanned early readmissions is a hot button issue that has drawn considerable attention from health policy makers. Roughly 20% of Medicare beneficiaries are readmitted within 30 days of hospitalization. Nearly 90% of these readmissions are unplanned and potentially preventable. These readmissions account for $20 billion annually in Medicare hospital payments. And heart failure is the No. 1 cause of readmission within 30 days, noted Dr. Hernandez of the Duke Clinical Research Institute, Durham, N.C.

One audience member serving on a panel advising the Center for Medicare and Medicaid Services said “these are just the kind of data we've been looking for” in order to make recommendations to the agency regarding new hospital performance standards. However, she questioned whether a physician was necessarily the right person to do the early follow-up evaluation. Fine-tuning of outpatient heart failure management might be better done by a dedicated nurse practitioner or physician assistant.

The study was supported by grants from the American Heart Association, GlaxoSmithKline, Medtronic, and the Agency for Healthcare Research and Quality. Dr. Hernandez reported financial relationships with Johnson & Johnson, Medtronic, Merck, Novartis, and AstraZeneca. Other authors reported a variety of financial support from drug manufacturers, other health care companies, and nonprofit organizations.

Bruce Jancin, reporting from the annual scientific sessions of the ACC in Atlanta, contributed to this article.

Heart failure patients discharged from hospitals with high levels of early physician evaluation are less likely to be readmitted to the hospital within 30 days, according to an analysis of records on more than 30,000 heart failure patients from 225 hospitals.

However, most heart failure patients do not visit a physician within 7 days of discharge.

The analysis of data from the American Heart Association's Get With The Guidelines–Heart Failure (GWTG–HF) Registry linked to Medicare billing records, which looked at hospital-level rates of early outpatient follow-up after discharge during 2003–2006, found that the median rate of follow-up within 7 days of discharge was 38%.

“For patients with heart failure, the transition from inpatient to outpatient care can be an especially vulnerable period because of the age of the patients, complex medical regimens, the large number of comorbid conditions, and the multiple clinicians who may be involved,” wrote Dr. Adrian F. Hernandez of Duke University, Durham, N.C., and his coauthors. “Our findings highlight a need for improvement and greater uniformity in coordination of care from inpatient to outpatient settings.”

Overall, about 21% of heart failure patients were readmitted to the hospital within 30 days of discharge. Patients in hospitals with higher rates of early follow-up had a lower risk of readmission, the study found (JAMA 2010;303:1716–22).

After adjustment for case mix, admission laboratory results, provision of discharge instructions, and length of stay, the risk-adjusted hazard of 30-day readmission was 15% lower in the hospitals with higher rates of early follow-up, the study found. Whereas 20% of patients whose initial hospital stay took place in a hospital with the highest rates of early follow-up were readmitted, 23% of patients in the hospitals with the lowest follow-up rates were readmitted, a significant difference.

Still, the authors only found differences in rehospitalization rates in the hospitals that ranked in the lowest quartile of posthospitalization follow-up; rates at the other 75% of hospitals were similar. They also found some racial differences: The proportion of black patients was “markedly higher” among hospitals with the lowest rates of early follow-up.

They also found that patients discharged from hospitals with the highest rates of early follow-up by a cardiologist had lower risk of 30-day mortality, which they noted is consistent with other studies of cardiology care for heart failure.

Most follow-up during the transitional period, especially during the first week, is handled by general internists, the study authors found. More than two-thirds of patients hospitalized for heart failure are evaluated by a cardiologist during their inpatient stays, but fewer than 10% see a cardiologist within 7 days of hospital discharge. By 21 days post discharge, 76% of patients had been seen by any physician, and 25% by a cardiologist.

However, neither early follow-up with a cardiologist nor continuity of care from the same physician seen during the hospitalization was a significant predictor of 30-day readmission, they wrote.

Documentation of discharge instructions, which many physicians presume helps to ensure early follow-up and better outcomes, also was not associated with lower readmission rates. “This finding raises the possibility that discharge instructions are becoming rote processes that do not adequately address elements of care that ensure a safe transition,” the authors wrote.

The study provides evidence in support of guidelines recommending the use of postdischarge systems of care, the authors said. “Achieving early follow-up may be difficult for some physician practices, but models of care that include nurse practitioners or physician assistants under physician supervision may result in increased access to and timeliness of care.”

Reporting the results at the annual scientific session of the American College of Cardiology in Atlanta in March, Dr. Hernandez said that ensuring that patients hospitalized for heart failure are evaluated by a physician within 7 days after discharge is emerging as a potential new target for hospital quality improvement.

The problem of unplanned early readmissions is a hot button issue that has drawn considerable attention from health policy makers. Roughly 20% of Medicare beneficiaries are readmitted within 30 days of hospitalization. Nearly 90% of these readmissions are unplanned and potentially preventable. These readmissions account for $20 billion annually in Medicare hospital payments. And heart failure is the No. 1 cause of readmission within 30 days, noted Dr. Hernandez of the Duke Clinical Research Institute, Durham, N.C.

One audience member serving on a panel advising the Center for Medicare and Medicaid Services said “these are just the kind of data we've been looking for” in order to make recommendations to the agency regarding new hospital performance standards. However, she questioned whether a physician was necessarily the right person to do the early follow-up evaluation. Fine-tuning of outpatient heart failure management might be better done by a dedicated nurse practitioner or physician assistant.

The study was supported by grants from the American Heart Association, GlaxoSmithKline, Medtronic, and the Agency for Healthcare Research and Quality. Dr. Hernandez reported financial relationships with Johnson & Johnson, Medtronic, Merck, Novartis, and AstraZeneca. Other authors reported a variety of financial support from drug manufacturers, other health care companies, and nonprofit organizations.

Bruce Jancin, reporting from the annual scientific sessions of the ACC in Atlanta, contributed to this article.

Major Finding: In patients hospitalized for acute decompensated heart failure, treatment with intravenous furosemide produced similar outcomes whether patients received the drug as a twice-daily bolus or by continuous infusion, or whether patients received a low dose (80–240 mg/day) or high dose (200–600 mg/day).

Data Source: DOSE, a prospective, multicenter, randomized trial with 308 patients hospitalized for acute decompensated heart failure.

Disclosures: Dr. Felker has financial relationships with Corthera, Geron, Roche Diagnostics, Cytokinetics, BGMedicine, and Amgen. Dr. O'Connor has received grants from Roche Diagnostics and GE Healthcare. DOSE was funded by the National Heart, Lung, and Blood Institute.

ATLANTA — The first prospective, randomized trial to compare two different diuretic doses in patients with acute decompensated heart failure showed no clear-cut advantage to either a low or high dose, but the results may have shown a hint that higher doses have a few advantages, study investigators said.

Among experts not involved with the trial, opinion split on whether any valid difference by dose could be inferred from a study that failed to show significant differences in its primary end points.

“The top-line, take-home results were no differences,” between furosemide doses, or between twice-daily bolus injections or continuous infusion, Dr. G. Michael Felker said at the annual meeting of the American College of Cardiology.

“But when you look at the totality of the data, there are a lot of suggestions that you get quicker, more favorable results with the high dose,” including greater decongestion, a bigger reduction in blood levels of natriuretic peptide, and greater symptom relief,” said Dr. Felker, co-principal investigator of the study and a cardiologist and heart failure specialist at Duke University in Durham, N.C.

“If you're a practicing physician, there were important trends that suggest the higher-dose strategy had some favorable effects,” said Dr. Christopher M. O'Connor, co-principal investigator on the study and director of the Duke Heart Center. “We have no standard treatment for acute heart failure with diuretics. These results suggest a way to standardize care. Sometimes you need to make decisions based on imperfect data, on trends and secondary end points. These are the best available data in the world today on how to choose a furosemide dose.”

Others were less sure that results from the Diuretic Optimization Strategies Evaluation in Acute Heart Failure (DOSE) trial favored the higher furosemide dosage for patients hospitalized with acute decompensated heart failure.

“Based on this trial, I don't think there is a difference” between the doses used, said Dr. Scott D. Solomon of Brigham and Women's Hospital in Boston. “You still have to look at the overall trial results,” and in this case they showed no significant difference between the doses tested.”

“Many of us have been concerned that high-dose furosemide may hurt patients, and lead to cardiorenal hypoperfusion that may account for a lot of the negative outcomes that happen when we discharge patients,” but this study didn't show this, said Dr. Douglas Mann, professor and chief of the cardiovascular division at Washington University in St. Louis. Overall, patients “did a little better with symptoms” with the higher dose, “and you pay a small price with a slightly higher rise in serum creatinine levels.” The new findings “will have a major impact by giving us a baseline on how to approach treatment. One can take a conservative strategy at first, and then maybe escalate to a higher dose, which will probably be safe. The results tell you that you can decongest patients a bit more without excessive renal risk.”

DOSE enrolled 308 patients at U.S. hospitals within 24 hours of admission for acute decompensated heart failure. The amount of intravenous furosemide they received depended on the oral dose on which they had been maintained prior to hospitalization. Patients randomized to the low-dose group received the identical daily dose of furosemide they had been on before entering the hospital, from 80 to 240 mg/day. Patients randomized to the high-dose group received a daily dose of 200–600 mg/day, 2.5-fold higher than their usual oral dose. Patients who had routinely received a different loop diuretic before hospitalization had their prehospitalization dose converted to its furosemide equivalent. Patients also underwent a second, independent randomization based on whether they received the drug in hospital as a twice-daily bolus injection or as continuous infusion. In-hospital treatment continued for an average of about 60 hours.

Enrolled patients had an average age of 66, 73% were men, and 74% had been hospitalized for heart failure within the prior year. Their average left ventricular ejection fraction was 35%, their average creatinine level was 1.6 mg/dL, and their average level of N-terminal–pro brain natriuretic peptide (NT-proBNP) was more than 7,000 pg/mL.

The study's main efficacy end point was each patient's cumulative self-assessment of symptoms at five points during the first 3 days of treatment. The bolus and continuous infusion routes showed no difference for this outcome. The low- and high-dose groups also showed no significant difference, but the high-dose regimen produced an improvement in symptoms that just missed statistical significance, at P = .06.

The primary safety outcome was the average change in serum creatinine 72 hours after onset of treatment, and both pairs of treatment produced small, virtually identical creatinine changes.

During 60 days of follow-up, there were no significant differences in a combined outcome of death, rehospitalization, or emergency department visits.

In three secondary efficacy measures at 72 hours, the high dose produced significantly better results compared with the low dose: dyspnea severity, total weight loss, and total net fluid volume loss. The high dose also produced a larger reduction in serum levels of NT-proBNP that missed statistical significance, at P = .06.

The high-dose regimen also linked with worsening renal function at 72 hours, but the effect disappeared by a week after treatment onset. At 72 hours, 23% of patients in the high-dose group and 14% in the low-dose group had a 0.3-mg/dL or greater rise in serum creatinine, a significant difference.

Dr. Solomon and Dr. Mann had no disclosures relevant to this study.

'There are a lot of suggestions that you get quicker, more favorable results with the high dose' of furosemide.

Source DR. FELKER

My Take

Ultrafiltration Bests Diuretics at Any Dose for Acute HF

The DOSE findings will reassure physicians that even smaller diuretic doses, given as boluses, have some efficacy. If a physician is going to use a diuretic for heart failure, it should be at the lowest effective dose.

However, both low-dose and high-dose furosemide regimens in patients hospitalized with acute decompensated heart failure are associated with relatively high rates of hospital readmissions because diuretics do not effectively reduce total sodium burden, which is an important cause of congestion in these patients. Other drug treatments, including vasopressin antagonists and adenosine receptor blockers, have the same limitation.

The only treatment that effectively reduces sodium burden is ultrafiltration, also known as aquapheresis. It is therefore the best treatment for heart failure patients with recurrent, acute congestion episodes.

My associates and I showed the superiority of ultrafiltration over intravenous treatment with a loop diuretic in results from the Ultrafiltration Versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated Congestive Heart Failure (UNLOAD) trial (J. Am. Coll. Cardiol. 2007;49:675-83). This multicenter study randomized 200 patients, and showed that ultrafiltration resulted in significantly better weight and net fluid loss within 2 days of treatment. During 90-day follow-up, the ultrafiltration patients had significantly fewer rehospitalizations and significantly fewer days spent rehospitalized compared with diuretic-treated patients.

Unfortunately, ultrafiltration has not caught on as the preferred method for managing acute heart failure in U.S. patients. It may be because only a single study has been done, and some physicians may want results from a confirmatory study before they adopt ultrafiltration.

Other factors have helped keep diuretics on top: First is habit; diuretics have traditionally been the primary therapy for acute decompensation. Also, the ultrafiltration equipment manufacturer, CHF Solutions, has had a limited marketing effort, although this may change now that the larger Gambro has acquired it. Another important issue is availability. Although most centers with a heart failure program have access to ultrafiltration, many U.S. patients with acute heart failure decompensation receive treatment at hospitals without heart failure centers.

Despite these limitations, I believe that ultrafiltration is the preferred treatment. Diuretics are less effective because they remove hypotonic fluid, without relieving sodium burden. Diuretics also enhance neurohormonal activation, another detrimental effect on patients. Ultrafiltration is unique in its ability to remove isotonic fluid, which gets sodium out of patients. No treatment of acute decompensation can be effective unless it reduces a patient's sodium burden.

A study now in progress, run by the National Heart, Lung, and Blood Institute's Heart Failure Network, involves a second comparison of ultrafiltration and diuretic treatment, specifically in patients who have worsening renal function during their decompensation episode.

MARIA ROSA COSTANZO, M.D., is medical director of the heart failure and pulmonary arterial hypertension programs at Midwest Heart Specialists in Naperville, Ill. She has served as speaker and consultant to, and received research support from, CHF Solutions.

Major Finding: In patients hospitalized for acute decompensated heart failure, treatment with intravenous furosemide produced similar outcomes whether patients received the drug as a twice-daily bolus or by continuous infusion, or whether patients received a low dose (80–240 mg/day) or high dose (200–600 mg/day).

Data Source: DOSE, a prospective, multicenter, randomized trial with 308 patients hospitalized for acute decompensated heart failure.

Disclosures: Dr. Felker has financial relationships with Corthera, Geron, Roche Diagnostics, Cytokinetics, BGMedicine, and Amgen. Dr. O'Connor has received grants from Roche Diagnostics and GE Healthcare. DOSE was funded by the National Heart, Lung, and Blood Institute.

ATLANTA — The first prospective, randomized trial to compare two different diuretic doses in patients with acute decompensated heart failure showed no clear-cut advantage to either a low or high dose, but the results may have shown a hint that higher doses have a few advantages, study investigators said.

Among experts not involved with the trial, opinion split on whether any valid difference by dose could be inferred from a study that failed to show significant differences in its primary end points.

“The top-line, take-home results were no differences,” between furosemide doses, or between twice-daily bolus injections or continuous infusion, Dr. G. Michael Felker said at the annual meeting of the American College of Cardiology.

“But when you look at the totality of the data, there are a lot of suggestions that you get quicker, more favorable results with the high dose,” including greater decongestion, a bigger reduction in blood levels of natriuretic peptide, and greater symptom relief,” said Dr. Felker, co-principal investigator of the study and a cardiologist and heart failure specialist at Duke University in Durham, N.C.

“If you're a practicing physician, there were important trends that suggest the higher-dose strategy had some favorable effects,” said Dr. Christopher M. O'Connor, co-principal investigator on the study and director of the Duke Heart Center. “We have no standard treatment for acute heart failure with diuretics. These results suggest a way to standardize care. Sometimes you need to make decisions based on imperfect data, on trends and secondary end points. These are the best available data in the world today on how to choose a furosemide dose.”

Others were less sure that results from the Diuretic Optimization Strategies Evaluation in Acute Heart Failure (DOSE) trial favored the higher furosemide dosage for patients hospitalized with acute decompensated heart failure.

“Based on this trial, I don't think there is a difference” between the doses used, said Dr. Scott D. Solomon of Brigham and Women's Hospital in Boston. “You still have to look at the overall trial results,” and in this case they showed no significant difference between the doses tested.”

“Many of us have been concerned that high-dose furosemide may hurt patients, and lead to cardiorenal hypoperfusion that may account for a lot of the negative outcomes that happen when we discharge patients,” but this study didn't show this, said Dr. Douglas Mann, professor and chief of the cardiovascular division at Washington University in St. Louis. Overall, patients “did a little better with symptoms” with the higher dose, “and you pay a small price with a slightly higher rise in serum creatinine levels.” The new findings “will have a major impact by giving us a baseline on how to approach treatment. One can take a conservative strategy at first, and then maybe escalate to a higher dose, which will probably be safe. The results tell you that you can decongest patients a bit more without excessive renal risk.”

DOSE enrolled 308 patients at U.S. hospitals within 24 hours of admission for acute decompensated heart failure. The amount of intravenous furosemide they received depended on the oral dose on which they had been maintained prior to hospitalization. Patients randomized to the low-dose group received the identical daily dose of furosemide they had been on before entering the hospital, from 80 to 240 mg/day. Patients randomized to the high-dose group received a daily dose of 200–600 mg/day, 2.5-fold higher than their usual oral dose. Patients who had routinely received a different loop diuretic before hospitalization had their prehospitalization dose converted to its furosemide equivalent. Patients also underwent a second, independent randomization based on whether they received the drug in hospital as a twice-daily bolus injection or as continuous infusion. In-hospital treatment continued for an average of about 60 hours.

Enrolled patients had an average age of 66, 73% were men, and 74% had been hospitalized for heart failure within the prior year. Their average left ventricular ejection fraction was 35%, their average creatinine level was 1.6 mg/dL, and their average level of N-terminal–pro brain natriuretic peptide (NT-proBNP) was more than 7,000 pg/mL.

The study's main efficacy end point was each patient's cumulative self-assessment of symptoms at five points during the first 3 days of treatment. The bolus and continuous infusion routes showed no difference for this outcome. The low- and high-dose groups also showed no significant difference, but the high-dose regimen produced an improvement in symptoms that just missed statistical significance, at P = .06.

The primary safety outcome was the average change in serum creatinine 72 hours after onset of treatment, and both pairs of treatment produced small, virtually identical creatinine changes.

During 60 days of follow-up, there were no significant differences in a combined outcome of death, rehospitalization, or emergency department visits.

In three secondary efficacy measures at 72 hours, the high dose produced significantly better results compared with the low dose: dyspnea severity, total weight loss, and total net fluid volume loss. The high dose also produced a larger reduction in serum levels of NT-proBNP that missed statistical significance, at P = .06.

The high-dose regimen also linked with worsening renal function at 72 hours, but the effect disappeared by a week after treatment onset. At 72 hours, 23% of patients in the high-dose group and 14% in the low-dose group had a 0.3-mg/dL or greater rise in serum creatinine, a significant difference.

Dr. Solomon and Dr. Mann had no disclosures relevant to this study.

'There are a lot of suggestions that you get quicker, more favorable results with the high dose' of furosemide.

Source DR. FELKER

My Take

Ultrafiltration Bests Diuretics at Any Dose for Acute HF

The DOSE findings will reassure physicians that even smaller diuretic doses, given as boluses, have some efficacy. If a physician is going to use a diuretic for heart failure, it should be at the lowest effective dose.

However, both low-dose and high-dose furosemide regimens in patients hospitalized with acute decompensated heart failure are associated with relatively high rates of hospital readmissions because diuretics do not effectively reduce total sodium burden, which is an important cause of congestion in these patients. Other drug treatments, including vasopressin antagonists and adenosine receptor blockers, have the same limitation.

The only treatment that effectively reduces sodium burden is ultrafiltration, also known as aquapheresis. It is therefore the best treatment for heart failure patients with recurrent, acute congestion episodes.

My associates and I showed the superiority of ultrafiltration over intravenous treatment with a loop diuretic in results from the Ultrafiltration Versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated Congestive Heart Failure (UNLOAD) trial (J. Am. Coll. Cardiol. 2007;49:675-83). This multicenter study randomized 200 patients, and showed that ultrafiltration resulted in significantly better weight and net fluid loss within 2 days of treatment. During 90-day follow-up, the ultrafiltration patients had significantly fewer rehospitalizations and significantly fewer days spent rehospitalized compared with diuretic-treated patients.

Unfortunately, ultrafiltration has not caught on as the preferred method for managing acute heart failure in U.S. patients. It may be because only a single study has been done, and some physicians may want results from a confirmatory study before they adopt ultrafiltration.

Other factors have helped keep diuretics on top: First is habit; diuretics have traditionally been the primary therapy for acute decompensation. Also, the ultrafiltration equipment manufacturer, CHF Solutions, has had a limited marketing effort, although this may change now that the larger Gambro has acquired it. Another important issue is availability. Although most centers with a heart failure program have access to ultrafiltration, many U.S. patients with acute heart failure decompensation receive treatment at hospitals without heart failure centers.

Despite these limitations, I believe that ultrafiltration is the preferred treatment. Diuretics are less effective because they remove hypotonic fluid, without relieving sodium burden. Diuretics also enhance neurohormonal activation, another detrimental effect on patients. Ultrafiltration is unique in its ability to remove isotonic fluid, which gets sodium out of patients. No treatment of acute decompensation can be effective unless it reduces a patient's sodium burden.

A study now in progress, run by the National Heart, Lung, and Blood Institute's Heart Failure Network, involves a second comparison of ultrafiltration and diuretic treatment, specifically in patients who have worsening renal function during their decompensation episode.

MARIA ROSA COSTANZO, M.D., is medical director of the heart failure and pulmonary arterial hypertension programs at Midwest Heart Specialists in Naperville, Ill. She has served as speaker and consultant to, and received research support from, CHF Solutions.

Major Finding: In patients hospitalized for acute decompensated heart failure, treatment with intravenous furosemide produced similar outcomes whether patients received the drug as a twice-daily bolus or by continuous infusion, or whether patients received a low dose (80–240 mg/day) or high dose (200–600 mg/day).

Data Source: DOSE, a prospective, multicenter, randomized trial with 308 patients hospitalized for acute decompensated heart failure.

Disclosures: Dr. Felker has financial relationships with Corthera, Geron, Roche Diagnostics, Cytokinetics, BGMedicine, and Amgen. Dr. O'Connor has received grants from Roche Diagnostics and GE Healthcare. DOSE was funded by the National Heart, Lung, and Blood Institute.

ATLANTA — The first prospective, randomized trial to compare two different diuretic doses in patients with acute decompensated heart failure showed no clear-cut advantage to either a low or high dose, but the results may have shown a hint that higher doses have a few advantages, study investigators said.

Among experts not involved with the trial, opinion split on whether any valid difference by dose could be inferred from a study that failed to show significant differences in its primary end points.

“The top-line, take-home results were no differences,” between furosemide doses, or between twice-daily bolus injections or continuous infusion, Dr. G. Michael Felker said at the annual meeting of the American College of Cardiology.

“But when you look at the totality of the data, there are a lot of suggestions that you get quicker, more favorable results with the high dose,” including greater decongestion, a bigger reduction in blood levels of natriuretic peptide, and greater symptom relief,” said Dr. Felker, co-principal investigator of the study and a cardiologist and heart failure specialist at Duke University in Durham, N.C.

“If you're a practicing physician, there were important trends that suggest the higher-dose strategy had some favorable effects,” said Dr. Christopher M. O'Connor, co-principal investigator on the study and director of the Duke Heart Center. “We have no standard treatment for acute heart failure with diuretics. These results suggest a way to standardize care. Sometimes you need to make decisions based on imperfect data, on trends and secondary end points. These are the best available data in the world today on how to choose a furosemide dose.”

Others were less sure that results from the Diuretic Optimization Strategies Evaluation in Acute Heart Failure (DOSE) trial favored the higher furosemide dosage for patients hospitalized with acute decompensated heart failure.

“Based on this trial, I don't think there is a difference” between the doses used, said Dr. Scott D. Solomon of Brigham and Women's Hospital in Boston. “You still have to look at the overall trial results,” and in this case they showed no significant difference between the doses tested.”

“Many of us have been concerned that high-dose furosemide may hurt patients, and lead to cardiorenal hypoperfusion that may account for a lot of the negative outcomes that happen when we discharge patients,” but this study didn't show this, said Dr. Douglas Mann, professor and chief of the cardiovascular division at Washington University in St. Louis. Overall, patients “did a little better with symptoms” with the higher dose, “and you pay a small price with a slightly higher rise in serum creatinine levels.” The new findings “will have a major impact by giving us a baseline on how to approach treatment. One can take a conservative strategy at first, and then maybe escalate to a higher dose, which will probably be safe. The results tell you that you can decongest patients a bit more without excessive renal risk.”

DOSE enrolled 308 patients at U.S. hospitals within 24 hours of admission for acute decompensated heart failure. The amount of intravenous furosemide they received depended on the oral dose on which they had been maintained prior to hospitalization. Patients randomized to the low-dose group received the identical daily dose of furosemide they had been on before entering the hospital, from 80 to 240 mg/day. Patients randomized to the high-dose group received a daily dose of 200–600 mg/day, 2.5-fold higher than their usual oral dose. Patients who had routinely received a different loop diuretic before hospitalization had their prehospitalization dose converted to its furosemide equivalent. Patients also underwent a second, independent randomization based on whether they received the drug in hospital as a twice-daily bolus injection or as continuous infusion. In-hospital treatment continued for an average of about 60 hours.

Enrolled patients had an average age of 66, 73% were men, and 74% had been hospitalized for heart failure within the prior year. Their average left ventricular ejection fraction was 35%, their average creatinine level was 1.6 mg/dL, and their average level of N-terminal–pro brain natriuretic peptide (NT-proBNP) was more than 7,000 pg/mL.

The study's main efficacy end point was each patient's cumulative self-assessment of symptoms at five points during the first 3 days of treatment. The bolus and continuous infusion routes showed no difference for this outcome. The low- and high-dose groups also showed no significant difference, but the high-dose regimen produced an improvement in symptoms that just missed statistical significance, at P = .06.

The primary safety outcome was the average change in serum creatinine 72 hours after onset of treatment, and both pairs of treatment produced small, virtually identical creatinine changes.

During 60 days of follow-up, there were no significant differences in a combined outcome of death, rehospitalization, or emergency department visits.

In three secondary efficacy measures at 72 hours, the high dose produced significantly better results compared with the low dose: dyspnea severity, total weight loss, and total net fluid volume loss. The high dose also produced a larger reduction in serum levels of NT-proBNP that missed statistical significance, at P = .06.

The high-dose regimen also linked with worsening renal function at 72 hours, but the effect disappeared by a week after treatment onset. At 72 hours, 23% of patients in the high-dose group and 14% in the low-dose group had a 0.3-mg/dL or greater rise in serum creatinine, a significant difference.

Dr. Solomon and Dr. Mann had no disclosures relevant to this study.

'There are a lot of suggestions that you get quicker, more favorable results with the high dose' of furosemide.

Source DR. FELKER

My Take

Ultrafiltration Bests Diuretics at Any Dose for Acute HF

The DOSE findings will reassure physicians that even smaller diuretic doses, given as boluses, have some efficacy. If a physician is going to use a diuretic for heart failure, it should be at the lowest effective dose.

However, both low-dose and high-dose furosemide regimens in patients hospitalized with acute decompensated heart failure are associated with relatively high rates of hospital readmissions because diuretics do not effectively reduce total sodium burden, which is an important cause of congestion in these patients. Other drug treatments, including vasopressin antagonists and adenosine receptor blockers, have the same limitation.

The only treatment that effectively reduces sodium burden is ultrafiltration, also known as aquapheresis. It is therefore the best treatment for heart failure patients with recurrent, acute congestion episodes.

My associates and I showed the superiority of ultrafiltration over intravenous treatment with a loop diuretic in results from the Ultrafiltration Versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated Congestive Heart Failure (UNLOAD) trial (J. Am. Coll. Cardiol. 2007;49:675-83). This multicenter study randomized 200 patients, and showed that ultrafiltration resulted in significantly better weight and net fluid loss within 2 days of treatment. During 90-day follow-up, the ultrafiltration patients had significantly fewer rehospitalizations and significantly fewer days spent rehospitalized compared with diuretic-treated patients.

Unfortunately, ultrafiltration has not caught on as the preferred method for managing acute heart failure in U.S. patients. It may be because only a single study has been done, and some physicians may want results from a confirmatory study before they adopt ultrafiltration.

Other factors have helped keep diuretics on top: First is habit; diuretics have traditionally been the primary therapy for acute decompensation. Also, the ultrafiltration equipment manufacturer, CHF Solutions, has had a limited marketing effort, although this may change now that the larger Gambro has acquired it. Another important issue is availability. Although most centers with a heart failure program have access to ultrafiltration, many U.S. patients with acute heart failure decompensation receive treatment at hospitals without heart failure centers.

Despite these limitations, I believe that ultrafiltration is the preferred treatment. Diuretics are less effective because they remove hypotonic fluid, without relieving sodium burden. Diuretics also enhance neurohormonal activation, another detrimental effect on patients. Ultrafiltration is unique in its ability to remove isotonic fluid, which gets sodium out of patients. No treatment of acute decompensation can be effective unless it reduces a patient's sodium burden.

A study now in progress, run by the National Heart, Lung, and Blood Institute's Heart Failure Network, involves a second comparison of ultrafiltration and diuretic treatment, specifically in patients who have worsening renal function during their decompensation episode.

MARIA ROSA COSTANZO, M.D., is medical director of the heart failure and pulmonary arterial hypertension programs at Midwest Heart Specialists in Naperville, Ill. She has served as speaker and consultant to, and received research support from, CHF Solutions.

Nearly one-fifth of patients with acute heart failure who receive implantable cardioverter defibrillators and cardiac resynchronization devices are at least 80 years old, even though most clinical trials of the devices' safety and effectiveness excluded this age group, according to a report in the Archives of Internal Medicine.

Procedure-related complications are more frequent in elderly than in younger patients, and in-hospital mortality is higher. These findings indicate that additional studies are needed “to clarify the appropriateness of device implantation in older patients with heart failure, as well as the merits of less invasive options,” said Jason P. Swindle of the Center for Outcomes Research at Saint Louis University, and his associates.

The investigators studied age-specific practices in the placement of ICDs and cardiac resynchronization therapy (CRT) because “few data exist on outcomes in older patients, as pivotal device trials have generally enrolled a young cohort of patients relative to those observed in the clinical setting.”

Using a national database comprising several hundred hospitals and health care systems, they assessed the records of 26,887 adults admitted to acute care hospitals for heart failure in 2004–2006 who received an implantable cardiac device. The median patient age was 70 years, markedly older than the median ages of 58–67 years in major clinical trials.

About half of the patients received ICDs, 44% of patients received CRT with defibrillators, and the remainder received CRT without defibrillators.

A total of 17.5% (4,694) of these patients were aged 80 or older; of those, 6.6% (309) were 89 years and older.

In-hospital mortality was significantly higher in patients older than 85 (2.2%) and in those aged 80–85 (1.2%), compared with younger patients (0.7%), Mr. Swindle and his colleagues wrote (Arch. Intern. Med. 2010;170:631-7).

Advanced age also was associated with increased length of stay and higher total costs of hospitalization.

This study was not designed to assess longer-term outcomes such as 30-day or 1-year mortality, nor could it address other outcomes such as readmission rates or quality of life issues, they noted.

In an accompanying editorial, Dr. Fred Kusumoto of the Mayo Clinic, Jacksonville, Fla., said that these findings confirm that patients who receive cardiac devices in actual practice vary significantly from the study subjects in whom the devices were initially tested. “It is imperative that future trial design considers the broad diversity of the U.S. population,” he noted.

More importantly, “we must recognize the shortcomings of our current knowledge and how that affects individual decision making,” Dr. Kusumoto said (Arch. Intern. Med. 2010;170:638-9).

“For ICD implantation, each patient will have different questions and varying clinical benefit. It is important for each of us to understand the medical issues, take our own personal biases into account, and honor our patient's wishes,” he said.

The study was funded in part by the National Institutes of Health. Neither Mr. Swindle nor Dr. Kusumoto reported any financial conflicts of interest.

The average age of ICD and CRT patients is higher than that in clinical trials.

Source ©claudiobaba/iStockPhoto.com

Nearly one-fifth of patients with acute heart failure who receive implantable cardioverter defibrillators and cardiac resynchronization devices are at least 80 years old, even though most clinical trials of the devices' safety and effectiveness excluded this age group, according to a report in the Archives of Internal Medicine.

Procedure-related complications are more frequent in elderly than in younger patients, and in-hospital mortality is higher. These findings indicate that additional studies are needed “to clarify the appropriateness of device implantation in older patients with heart failure, as well as the merits of less invasive options,” said Jason P. Swindle of the Center for Outcomes Research at Saint Louis University, and his associates.

The investigators studied age-specific practices in the placement of ICDs and cardiac resynchronization therapy (CRT) because “few data exist on outcomes in older patients, as pivotal device trials have generally enrolled a young cohort of patients relative to those observed in the clinical setting.”

Using a national database comprising several hundred hospitals and health care systems, they assessed the records of 26,887 adults admitted to acute care hospitals for heart failure in 2004–2006 who received an implantable cardiac device. The median patient age was 70 years, markedly older than the median ages of 58–67 years in major clinical trials.

About half of the patients received ICDs, 44% of patients received CRT with defibrillators, and the remainder received CRT without defibrillators.

A total of 17.5% (4,694) of these patients were aged 80 or older; of those, 6.6% (309) were 89 years and older.

In-hospital mortality was significantly higher in patients older than 85 (2.2%) and in those aged 80–85 (1.2%), compared with younger patients (0.7%), Mr. Swindle and his colleagues wrote (Arch. Intern. Med. 2010;170:631-7).

Advanced age also was associated with increased length of stay and higher total costs of hospitalization.

This study was not designed to assess longer-term outcomes such as 30-day or 1-year mortality, nor could it address other outcomes such as readmission rates or quality of life issues, they noted.

In an accompanying editorial, Dr. Fred Kusumoto of the Mayo Clinic, Jacksonville, Fla., said that these findings confirm that patients who receive cardiac devices in actual practice vary significantly from the study subjects in whom the devices were initially tested. “It is imperative that future trial design considers the broad diversity of the U.S. population,” he noted.

More importantly, “we must recognize the shortcomings of our current knowledge and how that affects individual decision making,” Dr. Kusumoto said (Arch. Intern. Med. 2010;170:638-9).

“For ICD implantation, each patient will have different questions and varying clinical benefit. It is important for each of us to understand the medical issues, take our own personal biases into account, and honor our patient's wishes,” he said.

The study was funded in part by the National Institutes of Health. Neither Mr. Swindle nor Dr. Kusumoto reported any financial conflicts of interest.

The average age of ICD and CRT patients is higher than that in clinical trials.

Source ©claudiobaba/iStockPhoto.com

Nearly one-fifth of patients with acute heart failure who receive implantable cardioverter defibrillators and cardiac resynchronization devices are at least 80 years old, even though most clinical trials of the devices' safety and effectiveness excluded this age group, according to a report in the Archives of Internal Medicine.

Procedure-related complications are more frequent in elderly than in younger patients, and in-hospital mortality is higher. These findings indicate that additional studies are needed “to clarify the appropriateness of device implantation in older patients with heart failure, as well as the merits of less invasive options,” said Jason P. Swindle of the Center for Outcomes Research at Saint Louis University, and his associates.

The investigators studied age-specific practices in the placement of ICDs and cardiac resynchronization therapy (CRT) because “few data exist on outcomes in older patients, as pivotal device trials have generally enrolled a young cohort of patients relative to those observed in the clinical setting.”

Using a national database comprising several hundred hospitals and health care systems, they assessed the records of 26,887 adults admitted to acute care hospitals for heart failure in 2004–2006 who received an implantable cardiac device. The median patient age was 70 years, markedly older than the median ages of 58–67 years in major clinical trials.

About half of the patients received ICDs, 44% of patients received CRT with defibrillators, and the remainder received CRT without defibrillators.

A total of 17.5% (4,694) of these patients were aged 80 or older; of those, 6.6% (309) were 89 years and older.

In-hospital mortality was significantly higher in patients older than 85 (2.2%) and in those aged 80–85 (1.2%), compared with younger patients (0.7%), Mr. Swindle and his colleagues wrote (Arch. Intern. Med. 2010;170:631-7).

Advanced age also was associated with increased length of stay and higher total costs of hospitalization.

This study was not designed to assess longer-term outcomes such as 30-day or 1-year mortality, nor could it address other outcomes such as readmission rates or quality of life issues, they noted.

In an accompanying editorial, Dr. Fred Kusumoto of the Mayo Clinic, Jacksonville, Fla., said that these findings confirm that patients who receive cardiac devices in actual practice vary significantly from the study subjects in whom the devices were initially tested. “It is imperative that future trial design considers the broad diversity of the U.S. population,” he noted.

More importantly, “we must recognize the shortcomings of our current knowledge and how that affects individual decision making,” Dr. Kusumoto said (Arch. Intern. Med. 2010;170:638-9).

“For ICD implantation, each patient will have different questions and varying clinical benefit. It is important for each of us to understand the medical issues, take our own personal biases into account, and honor our patient's wishes,” he said.

The study was funded in part by the National Institutes of Health. Neither Mr. Swindle nor Dr. Kusumoto reported any financial conflicts of interest.

The average age of ICD and CRT patients is higher than that in clinical trials.

Source ©claudiobaba/iStockPhoto.com

SNOWMASS, COLO. — Advanced age is not a valid reason to exclude otherwise qualified patients from cardiac resynchronization therapy, a study indicates.

Dr. Jamie B. Conti often hears colleagues say, “I think that patient is too old for CRT.” But the 2008 American College of Cardiology/American Heart Association/Heart Rhythm Society CRT guidelines make no mention of an age cutoff. And Dr. Conti and coworkers recently conducted a study that concluded CRT is as effective—and safe—in heart failure patients above age 75 as in those who are younger, she noted at a conference sponsored by the ACC.

There has never been a randomized trial looking at the effects of CRT specifically in the elderly. So the researchers performed a subanalysis of 839 participants in two major randomized trials of CRT: the Multicenter InSync Randomized Clinical Evaluation (MIRACLE) and Multicenter InSync-ICD Randomized Clinical Evaluation (MIRACLE-ICD).

The over-75 cohort in the subanalysis comprised 174 patients. Another 297 patients were aged 65-75, and 368 were aged under 65 years. All received a CRT device, then were randomized to 6 months with the device activated or turned off.

All three age groups had significant improvements in New York Heart Association functional class and left ventricular ejection fraction (LVEF) with CRT activated compared with patients in whom the device was turned off, said Dr. Conti, professor of medicine and chief of the division of cardiovascular medicine at the University of Florida, Gainesville.

The improvement in NYHA class after 6 months with the CRT device turned on compared with CRT off amounted to a net 1.32 class units in the under-65 cohort, 1.27 units in the 65-75 age group, and 1.22 units in the oldest group. LVEF improved by 3.45% more with CRT on than off in the under-65 group, by 2.23% more in the 65- to 75-year-olds, and by 3.45% more in the over-75 group (J. Interv. Card. Electrophysiol. 2009;25:91-6).

In addition, there was a strong albeit nonsignificant trend for improvement in left ventricular end systolic volume with CRT turned on in patients over age 75. The LV end systolic volume fell by a mean of 17.68 mL from baseline with CRT on in the oldest cohort, compared with a 0.86-mL decrease with CRT off. LV end systolic volume fell by a mean of 35.1 mL more with CRT on than off in the under-65 group. The difference between CRT on and off in the 65–75 age group was a net 26.51-mL decrease.

Complication rates were no different in the three age groups, Dr. Conti said.

The ACC/AHA/HRS guidelines recommend CRT for patients with an LVEF of 35% or less, a QRS duration of at least 120 msec, and NYHA functional class III or ambulatory class IV despite optimal medical therapy. However, it seems likely that the indications will broaden to include patients in class I/II on the strength of the positive results of the Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE) trial, predicted Dr. Conti, who had no relevant financial interests.

CRT is as effective—and safe—in heart failure patients above age 75 as in those who are younger.

Source DR. CONTI

SNOWMASS, COLO. — Advanced age is not a valid reason to exclude otherwise qualified patients from cardiac resynchronization therapy, a study indicates.

Dr. Jamie B. Conti often hears colleagues say, “I think that patient is too old for CRT.” But the 2008 American College of Cardiology/American Heart Association/Heart Rhythm Society CRT guidelines make no mention of an age cutoff. And Dr. Conti and coworkers recently conducted a study that concluded CRT is as effective—and safe—in heart failure patients above age 75 as in those who are younger, she noted at a conference sponsored by the ACC.

There has never been a randomized trial looking at the effects of CRT specifically in the elderly. So the researchers performed a subanalysis of 839 participants in two major randomized trials of CRT: the Multicenter InSync Randomized Clinical Evaluation (MIRACLE) and Multicenter InSync-ICD Randomized Clinical Evaluation (MIRACLE-ICD).

The over-75 cohort in the subanalysis comprised 174 patients. Another 297 patients were aged 65-75, and 368 were aged under 65 years. All received a CRT device, then were randomized to 6 months with the device activated or turned off.

All three age groups had significant improvements in New York Heart Association functional class and left ventricular ejection fraction (LVEF) with CRT activated compared with patients in whom the device was turned off, said Dr. Conti, professor of medicine and chief of the division of cardiovascular medicine at the University of Florida, Gainesville.

The improvement in NYHA class after 6 months with the CRT device turned on compared with CRT off amounted to a net 1.32 class units in the under-65 cohort, 1.27 units in the 65-75 age group, and 1.22 units in the oldest group. LVEF improved by 3.45% more with CRT on than off in the under-65 group, by 2.23% more in the 65- to 75-year-olds, and by 3.45% more in the over-75 group (J. Interv. Card. Electrophysiol. 2009;25:91-6).

In addition, there was a strong albeit nonsignificant trend for improvement in left ventricular end systolic volume with CRT turned on in patients over age 75. The LV end systolic volume fell by a mean of 17.68 mL from baseline with CRT on in the oldest cohort, compared with a 0.86-mL decrease with CRT off. LV end systolic volume fell by a mean of 35.1 mL more with CRT on than off in the under-65 group. The difference between CRT on and off in the 65–75 age group was a net 26.51-mL decrease.

Complication rates were no different in the three age groups, Dr. Conti said.

The ACC/AHA/HRS guidelines recommend CRT for patients with an LVEF of 35% or less, a QRS duration of at least 120 msec, and NYHA functional class III or ambulatory class IV despite optimal medical therapy. However, it seems likely that the indications will broaden to include patients in class I/II on the strength of the positive results of the Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE) trial, predicted Dr. Conti, who had no relevant financial interests.

CRT is as effective—and safe—in heart failure patients above age 75 as in those who are younger.

Source DR. CONTI

SNOWMASS, COLO. — Advanced age is not a valid reason to exclude otherwise qualified patients from cardiac resynchronization therapy, a study indicates.

Dr. Jamie B. Conti often hears colleagues say, “I think that patient is too old for CRT.” But the 2008 American College of Cardiology/American Heart Association/Heart Rhythm Society CRT guidelines make no mention of an age cutoff. And Dr. Conti and coworkers recently conducted a study that concluded CRT is as effective—and safe—in heart failure patients above age 75 as in those who are younger, she noted at a conference sponsored by the ACC.

There has never been a randomized trial looking at the effects of CRT specifically in the elderly. So the researchers performed a subanalysis of 839 participants in two major randomized trials of CRT: the Multicenter InSync Randomized Clinical Evaluation (MIRACLE) and Multicenter InSync-ICD Randomized Clinical Evaluation (MIRACLE-ICD).

The over-75 cohort in the subanalysis comprised 174 patients. Another 297 patients were aged 65-75, and 368 were aged under 65 years. All received a CRT device, then were randomized to 6 months with the device activated or turned off.

All three age groups had significant improvements in New York Heart Association functional class and left ventricular ejection fraction (LVEF) with CRT activated compared with patients in whom the device was turned off, said Dr. Conti, professor of medicine and chief of the division of cardiovascular medicine at the University of Florida, Gainesville.

The improvement in NYHA class after 6 months with the CRT device turned on compared with CRT off amounted to a net 1.32 class units in the under-65 cohort, 1.27 units in the 65-75 age group, and 1.22 units in the oldest group. LVEF improved by 3.45% more with CRT on than off in the under-65 group, by 2.23% more in the 65- to 75-year-olds, and by 3.45% more in the over-75 group (J. Interv. Card. Electrophysiol. 2009;25:91-6).

In addition, there was a strong albeit nonsignificant trend for improvement in left ventricular end systolic volume with CRT turned on in patients over age 75. The LV end systolic volume fell by a mean of 17.68 mL from baseline with CRT on in the oldest cohort, compared with a 0.86-mL decrease with CRT off. LV end systolic volume fell by a mean of 35.1 mL more with CRT on than off in the under-65 group. The difference between CRT on and off in the 65–75 age group was a net 26.51-mL decrease.

Complication rates were no different in the three age groups, Dr. Conti said.

The ACC/AHA/HRS guidelines recommend CRT for patients with an LVEF of 35% or less, a QRS duration of at least 120 msec, and NYHA functional class III or ambulatory class IV despite optimal medical therapy. However, it seems likely that the indications will broaden to include patients in class I/II on the strength of the positive results of the Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE) trial, predicted Dr. Conti, who had no relevant financial interests.

CRT is as effective—and safe—in heart failure patients above age 75 as in those who are younger.

Source DR. CONTI

ORLANDO — Gout boosted the risk of death or hospitalization for heart failure in an observational, case-control study of more than 150,000 patients with heart failure.

Patients with heart failure and gout who were on long-term allopurinol treatment had a significantly reduced risk for death or heart failure hospitalization, Dr. George Thanassoulis said at the annual scientific sessions of the American Heart Association.

Allopurinol exerts its benefit for heart failure outcomes not by lowering blood levels of uric acid, but by inhibiting oxidative stress and the endothelial dysfunction that oxidative stress produces, said Dr. Thanassoulis, a cardiologist at Boston University and the Framingham (Mass.) Heart Study. He suggested that allopurinol inhibits xanthine oxidase, the same action that also blunts uric acid production.

The study used administrative health record data from Quebec residents aged older than 65 years. Cases were 14,327 people hospitalized for heart failure but without another heart failure hospitalization during the 3 years before the index episode, a restriction that helped ensure a uniform level of heart failure severity among the patients. Controls were 143,255 people in the Quebec database matched to the cases by follow-up duration and by calendar year.

The average age was 79 years among the cases and 77 years among the controls. Cases and controls were evenly split among men and women. Identification of gout relied on hospitalization, a physician visit, or a diagnostic code in the medical record.

During an average follow-up of 2 years, the rate of death or new heart failure hospitalization was 63% higher in the patients with gout than in those without gout, a statistically significant difference in an analysis that controlled for several demographic and clinical variables including age, gender, comorbidities, and medications.

The risk for death or heart failure hospitalization was even higher in patients who had acute gout, with a twofold higher risk in the adjusted analysis. The researchers defined acute gout as hospitalization or a physician visit for gout within 60 days of the index heart failure event.

Another pair of analyses looked at the impact of allopurinol treatment. Among patients with an index heart failure event who also had gout treatment with allopurinol, there was a significant 31% reduction in the subsequent rate of death or heart failure hospitalization in the adjusted analysis. This benefit was limited to the patients on chronic allopurinol treatment for more than 30 days. Patients on allopurinol for 30 days or less showed no significant reduction in mortality or new heart failure hospitalizations.

The allopurinol analysis also showed no link between the drug and outcomes for the entire heart failure population studied, suggesting that benefit from allopurinol is not general for all heart failure patients, only those with gout.

Dr. Thanassoulis and his associates had no conflicts of interest to disclose.

ORLANDO — Gout boosted the risk of death or hospitalization for heart failure in an observational, case-control study of more than 150,000 patients with heart failure.

Patients with heart failure and gout who were on long-term allopurinol treatment had a significantly reduced risk for death or heart failure hospitalization, Dr. George Thanassoulis said at the annual scientific sessions of the American Heart Association.

Allopurinol exerts its benefit for heart failure outcomes not by lowering blood levels of uric acid, but by inhibiting oxidative stress and the endothelial dysfunction that oxidative stress produces, said Dr. Thanassoulis, a cardiologist at Boston University and the Framingham (Mass.) Heart Study. He suggested that allopurinol inhibits xanthine oxidase, the same action that also blunts uric acid production.

The study used administrative health record data from Quebec residents aged older than 65 years. Cases were 14,327 people hospitalized for heart failure but without another heart failure hospitalization during the 3 years before the index episode, a restriction that helped ensure a uniform level of heart failure severity among the patients. Controls were 143,255 people in the Quebec database matched to the cases by follow-up duration and by calendar year.

The average age was 79 years among the cases and 77 years among the controls. Cases and controls were evenly split among men and women. Identification of gout relied on hospitalization, a physician visit, or a diagnostic code in the medical record.

During an average follow-up of 2 years, the rate of death or new heart failure hospitalization was 63% higher in the patients with gout than in those without gout, a statistically significant difference in an analysis that controlled for several demographic and clinical variables including age, gender, comorbidities, and medications.

The risk for death or heart failure hospitalization was even higher in patients who had acute gout, with a twofold higher risk in the adjusted analysis. The researchers defined acute gout as hospitalization or a physician visit for gout within 60 days of the index heart failure event.

Another pair of analyses looked at the impact of allopurinol treatment. Among patients with an index heart failure event who also had gout treatment with allopurinol, there was a significant 31% reduction in the subsequent rate of death or heart failure hospitalization in the adjusted analysis. This benefit was limited to the patients on chronic allopurinol treatment for more than 30 days. Patients on allopurinol for 30 days or less showed no significant reduction in mortality or new heart failure hospitalizations.

The allopurinol analysis also showed no link between the drug and outcomes for the entire heart failure population studied, suggesting that benefit from allopurinol is not general for all heart failure patients, only those with gout.

Dr. Thanassoulis and his associates had no conflicts of interest to disclose.

ORLANDO — Gout boosted the risk of death or hospitalization for heart failure in an observational, case-control study of more than 150,000 patients with heart failure.

Patients with heart failure and gout who were on long-term allopurinol treatment had a significantly reduced risk for death or heart failure hospitalization, Dr. George Thanassoulis said at the annual scientific sessions of the American Heart Association.

Allopurinol exerts its benefit for heart failure outcomes not by lowering blood levels of uric acid, but by inhibiting oxidative stress and the endothelial dysfunction that oxidative stress produces, said Dr. Thanassoulis, a cardiologist at Boston University and the Framingham (Mass.) Heart Study. He suggested that allopurinol inhibits xanthine oxidase, the same action that also blunts uric acid production.

The study used administrative health record data from Quebec residents aged older than 65 years. Cases were 14,327 people hospitalized for heart failure but without another heart failure hospitalization during the 3 years before the index episode, a restriction that helped ensure a uniform level of heart failure severity among the patients. Controls were 143,255 people in the Quebec database matched to the cases by follow-up duration and by calendar year.

The average age was 79 years among the cases and 77 years among the controls. Cases and controls were evenly split among men and women. Identification of gout relied on hospitalization, a physician visit, or a diagnostic code in the medical record.

During an average follow-up of 2 years, the rate of death or new heart failure hospitalization was 63% higher in the patients with gout than in those without gout, a statistically significant difference in an analysis that controlled for several demographic and clinical variables including age, gender, comorbidities, and medications.

The risk for death or heart failure hospitalization was even higher in patients who had acute gout, with a twofold higher risk in the adjusted analysis. The researchers defined acute gout as hospitalization or a physician visit for gout within 60 days of the index heart failure event.

Another pair of analyses looked at the impact of allopurinol treatment. Among patients with an index heart failure event who also had gout treatment with allopurinol, there was a significant 31% reduction in the subsequent rate of death or heart failure hospitalization in the adjusted analysis. This benefit was limited to the patients on chronic allopurinol treatment for more than 30 days. Patients on allopurinol for 30 days or less showed no significant reduction in mortality or new heart failure hospitalizations.

The allopurinol analysis also showed no link between the drug and outcomes for the entire heart failure population studied, suggesting that benefit from allopurinol is not general for all heart failure patients, only those with gout.

Dr. Thanassoulis and his associates had no conflicts of interest to disclose.

ORLANDO — Patients with heart failure had a greater than twofold increased risk of developing diabetes compared with people without heart failure in a review of more than 4,600 individuals in the Framingham Offspring Study.

The analysis also showed a strong association between severity of heart failure symptoms and risk for new-onset diabetes: Patients with higher New York Association Class heart failure faced a greater risk for developing diabetes than did patients with less severe heart failure symptoms, Dr. Ankit Rathod said at the annual scientific sessions of the American Heart Association.

The hypothesized causal link between heart failure and diabetes is the neurohormonal, sympathetic activation that characterizes heart failure. This leads to norepinephrine release, which can trigger insulin resistance and hence increased susceptibility to developing diabetes, said Dr. Rathod, an internist at Wayne State University in Detroit. In addition, patients with more severe heart failure symptoms have reduced activity, which might exacerbate insulin resistance and the risk for developing diabetes.

“I believe the connections between insulin resistance and neurohormonal activation are a real phenomenon,” said Dr. Clyde W. Yancy, medical director of the Baylor Heart and Vascular Institute at Baylor University Medical Center in Dallas. Treatment with drugs that block neurohormonal activation also cut development of diabetes, such as with ramipril in the HOPE study (N. Engl. J. Med 2000;342:145–53) and treatment with carvedilol in the CAPRICORN study (Lancet 2001;357:1385–90), he said.

Dr. Rathod collected data from the more than 4,900 people enrolled into the Framingham Offspring Study in 1971. He and his associates excluded people with a history of diabetes or heart failure at enrollment, and those who had missing data on their subsequent rate of new-onset diabetes. The 4,614 people included in the study had an average age of 35; about half were women.

During an average follow-up of 24 years, 123 developed heart failure, and 468 developed new-onset diabetes. Forty-one of the 123 patients (33%) who developed heart failure later developed diabetes, compared with 427 new cases of diabetes among the other 4,491 people (10%).

In a multivariate analysis that adjusted for baseline demographic and clinical differences, including drug treatments and baseline blood glucose levels, patients who first developed heart failure had a statistically significant 2.5-fold increased risk for later developing diabetes compared with the people who did not have heart failure.

Dr. Rathod and Dr. Yancy said they had no conflicts of interest.

Forty-one of the 123 patients (33%) who developed heart failure later developed diabetes.

Source DR. RATHOD

ORLANDO — Patients with heart failure had a greater than twofold increased risk of developing diabetes compared with people without heart failure in a review of more than 4,600 individuals in the Framingham Offspring Study.

The analysis also showed a strong association between severity of heart failure symptoms and risk for new-onset diabetes: Patients with higher New York Association Class heart failure faced a greater risk for developing diabetes than did patients with less severe heart failure symptoms, Dr. Ankit Rathod said at the annual scientific sessions of the American Heart Association.

The hypothesized causal link between heart failure and diabetes is the neurohormonal, sympathetic activation that characterizes heart failure. This leads to norepinephrine release, which can trigger insulin resistance and hence increased susceptibility to developing diabetes, said Dr. Rathod, an internist at Wayne State University in Detroit. In addition, patients with more severe heart failure symptoms have reduced activity, which might exacerbate insulin resistance and the risk for developing diabetes.

“I believe the connections between insulin resistance and neurohormonal activation are a real phenomenon,” said Dr. Clyde W. Yancy, medical director of the Baylor Heart and Vascular Institute at Baylor University Medical Center in Dallas. Treatment with drugs that block neurohormonal activation also cut development of diabetes, such as with ramipril in the HOPE study (N. Engl. J. Med 2000;342:145–53) and treatment with carvedilol in the CAPRICORN study (Lancet 2001;357:1385–90), he said.

Dr. Rathod collected data from the more than 4,900 people enrolled into the Framingham Offspring Study in 1971. He and his associates excluded people with a history of diabetes or heart failure at enrollment, and those who had missing data on their subsequent rate of new-onset diabetes. The 4,614 people included in the study had an average age of 35; about half were women.

During an average follow-up of 24 years, 123 developed heart failure, and 468 developed new-onset diabetes. Forty-one of the 123 patients (33%) who developed heart failure later developed diabetes, compared with 427 new cases of diabetes among the other 4,491 people (10%).

In a multivariate analysis that adjusted for baseline demographic and clinical differences, including drug treatments and baseline blood glucose levels, patients who first developed heart failure had a statistically significant 2.5-fold increased risk for later developing diabetes compared with the people who did not have heart failure.

Dr. Rathod and Dr. Yancy said they had no conflicts of interest.

Forty-one of the 123 patients (33%) who developed heart failure later developed diabetes.

Source DR. RATHOD

ORLANDO — Patients with heart failure had a greater than twofold increased risk of developing diabetes compared with people without heart failure in a review of more than 4,600 individuals in the Framingham Offspring Study.

The analysis also showed a strong association between severity of heart failure symptoms and risk for new-onset diabetes: Patients with higher New York Association Class heart failure faced a greater risk for developing diabetes than did patients with less severe heart failure symptoms, Dr. Ankit Rathod said at the annual scientific sessions of the American Heart Association.

The hypothesized causal link between heart failure and diabetes is the neurohormonal, sympathetic activation that characterizes heart failure. This leads to norepinephrine release, which can trigger insulin resistance and hence increased susceptibility to developing diabetes, said Dr. Rathod, an internist at Wayne State University in Detroit. In addition, patients with more severe heart failure symptoms have reduced activity, which might exacerbate insulin resistance and the risk for developing diabetes.

“I believe the connections between insulin resistance and neurohormonal activation are a real phenomenon,” said Dr. Clyde W. Yancy, medical director of the Baylor Heart and Vascular Institute at Baylor University Medical Center in Dallas. Treatment with drugs that block neurohormonal activation also cut development of diabetes, such as with ramipril in the HOPE study (N. Engl. J. Med 2000;342:145–53) and treatment with carvedilol in the CAPRICORN study (Lancet 2001;357:1385–90), he said.

Dr. Rathod collected data from the more than 4,900 people enrolled into the Framingham Offspring Study in 1971. He and his associates excluded people with a history of diabetes or heart failure at enrollment, and those who had missing data on their subsequent rate of new-onset diabetes. The 4,614 people included in the study had an average age of 35; about half were women.

During an average follow-up of 24 years, 123 developed heart failure, and 468 developed new-onset diabetes. Forty-one of the 123 patients (33%) who developed heart failure later developed diabetes, compared with 427 new cases of diabetes among the other 4,491 people (10%).

In a multivariate analysis that adjusted for baseline demographic and clinical differences, including drug treatments and baseline blood glucose levels, patients who first developed heart failure had a statistically significant 2.5-fold increased risk for later developing diabetes compared with the people who did not have heart failure.

Dr. Rathod and Dr. Yancy said they had no conflicts of interest.

Forty-one of the 123 patients (33%) who developed heart failure later developed diabetes.

Source DR. RATHOD

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

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

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

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

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

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

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

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

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

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

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

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

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

Source DR. HERZOG

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

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

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

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

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

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

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

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

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

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

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

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

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

Source DR. HERZOG

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

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

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

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

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

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

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

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

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

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

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

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

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

Source DR. HERZOG

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Source DR. YANCY

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

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

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

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

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

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

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

Source DR. YANCY

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

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

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

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

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

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

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

Source DR. YANCY