Heart Failure

Case reports that have raised concerns about a possible link between drugs used to treat attention-deficit/hyperactivity disorder and an increased risk of serious cardiovascular events, but no evidence of such a link was found in a large retrospective cohort study involving data from more than 1.2 million children and young adults.

Although case reports from adverse-event reporting systems are important for helping to identify safety signals, they cannot be relied upon to quantify risk, and the findings of the current study, which are consistent with several other studies, suggest that risk is low, according to Dr. William O. Cooper of Vanderbilt University, Nashville, Tenn., and his colleagues.

The findings also raise questions about regulatory and policy decisions that followed a number of adverse-event reports in the United States and Canada.

"In Canada, Health Canada removed and then reinstated marketing of extended-release mixed amphetamine salts. In the United States, three different [Food and Drug Administration] advisory committees considered the issue and recommended a black-box warning for stimulants, as well as a medication guide for patients," the investigators wrote online in the Nov. 1 issue of the New England Journal of Medicine.

These and others policies, they wrote, "led to concern and confusion among health care providers, patients, and families about the risks of these drugs."

The current study involved nearly 2.6 million person-years of follow-up, including more than 373,000 person-years of current use of ADHD drugs. Neither current use nor former use was associated with an increased risk for serious cardiovascular events, compared with non-use. The adjusted hazard ratios were 0.75 for current use and 1.03 for former use (N. Engl. J. Med. 2011 Nov. 1 [doi:10.1056/NEJMoa1110212]).

Furthermore, current use was not associated with an increased risk for any individual end points in the study, including sudden cardiac death, acute myocardial infarction, and stroke. The investigators also saw no increase in risk in current users when former users (rather than nonusers) served as the reference group. That yielded an adjusted hazard ratio of 0.70.

The study cohort included participants aged 2 to 24 years in four large health plans. The investigators matched data from computerized health records to state death certificates and the National Death Index to identify serious cardiovascular events. They compared event rates in users of the ADHD drugs methylphenidate, dexmethylphenidate, dextroamphetamines, amphetamine salts, atomoxetine, and pemoline, and up to two nonuser controls subjects. In all, there were 3.1 serious cardiovascular events per 100,000 person-years.

The point estimates of the relative risks for ADHD drugs in this study did not indicate increased risk, but the upper limit of the 95% confidence interval suggested that a doubling in the risk could not be ruled out. However, several alternative analyses to test the robustness of the findings supported those of the primary analysis, the investigators explained, concluding that "the absolute magnitude of any increased risk would be low."

The Agency for Healthcare Research and Quality, the Department of Health and Human Services, and the Food and Drug Administration funded the study. Some authors reported disclosures other than grant funding from these organizations, including receiving grant funding or owning stock or stock options from various pharmaceutical companies.

Case reports that have raised concerns about a possible link between drugs used to treat attention-deficit/hyperactivity disorder and an increased risk of serious cardiovascular events, but no evidence of such a link was found in a large retrospective cohort study involving data from more than 1.2 million children and young adults.

Although case reports from adverse-event reporting systems are important for helping to identify safety signals, they cannot be relied upon to quantify risk, and the findings of the current study, which are consistent with several other studies, suggest that risk is low, according to Dr. William O. Cooper of Vanderbilt University, Nashville, Tenn., and his colleagues.

The findings also raise questions about regulatory and policy decisions that followed a number of adverse-event reports in the United States and Canada.

"In Canada, Health Canada removed and then reinstated marketing of extended-release mixed amphetamine salts. In the United States, three different [Food and Drug Administration] advisory committees considered the issue and recommended a black-box warning for stimulants, as well as a medication guide for patients," the investigators wrote online in the Nov. 1 issue of the New England Journal of Medicine.

These and others policies, they wrote, "led to concern and confusion among health care providers, patients, and families about the risks of these drugs."

The current study involved nearly 2.6 million person-years of follow-up, including more than 373,000 person-years of current use of ADHD drugs. Neither current use nor former use was associated with an increased risk for serious cardiovascular events, compared with non-use. The adjusted hazard ratios were 0.75 for current use and 1.03 for former use (N. Engl. J. Med. 2011 Nov. 1 [doi:10.1056/NEJMoa1110212]).

Furthermore, current use was not associated with an increased risk for any individual end points in the study, including sudden cardiac death, acute myocardial infarction, and stroke. The investigators also saw no increase in risk in current users when former users (rather than nonusers) served as the reference group. That yielded an adjusted hazard ratio of 0.70.

The study cohort included participants aged 2 to 24 years in four large health plans. The investigators matched data from computerized health records to state death certificates and the National Death Index to identify serious cardiovascular events. They compared event rates in users of the ADHD drugs methylphenidate, dexmethylphenidate, dextroamphetamines, amphetamine salts, atomoxetine, and pemoline, and up to two nonuser controls subjects. In all, there were 3.1 serious cardiovascular events per 100,000 person-years.

The point estimates of the relative risks for ADHD drugs in this study did not indicate increased risk, but the upper limit of the 95% confidence interval suggested that a doubling in the risk could not be ruled out. However, several alternative analyses to test the robustness of the findings supported those of the primary analysis, the investigators explained, concluding that "the absolute magnitude of any increased risk would be low."

The Agency for Healthcare Research and Quality, the Department of Health and Human Services, and the Food and Drug Administration funded the study. Some authors reported disclosures other than grant funding from these organizations, including receiving grant funding or owning stock or stock options from various pharmaceutical companies.

Case reports that have raised concerns about a possible link between drugs used to treat attention-deficit/hyperactivity disorder and an increased risk of serious cardiovascular events, but no evidence of such a link was found in a large retrospective cohort study involving data from more than 1.2 million children and young adults.

Although case reports from adverse-event reporting systems are important for helping to identify safety signals, they cannot be relied upon to quantify risk, and the findings of the current study, which are consistent with several other studies, suggest that risk is low, according to Dr. William O. Cooper of Vanderbilt University, Nashville, Tenn., and his colleagues.

The findings also raise questions about regulatory and policy decisions that followed a number of adverse-event reports in the United States and Canada.

"In Canada, Health Canada removed and then reinstated marketing of extended-release mixed amphetamine salts. In the United States, three different [Food and Drug Administration] advisory committees considered the issue and recommended a black-box warning for stimulants, as well as a medication guide for patients," the investigators wrote online in the Nov. 1 issue of the New England Journal of Medicine.

These and others policies, they wrote, "led to concern and confusion among health care providers, patients, and families about the risks of these drugs."

The current study involved nearly 2.6 million person-years of follow-up, including more than 373,000 person-years of current use of ADHD drugs. Neither current use nor former use was associated with an increased risk for serious cardiovascular events, compared with non-use. The adjusted hazard ratios were 0.75 for current use and 1.03 for former use (N. Engl. J. Med. 2011 Nov. 1 [doi:10.1056/NEJMoa1110212]).

Furthermore, current use was not associated with an increased risk for any individual end points in the study, including sudden cardiac death, acute myocardial infarction, and stroke. The investigators also saw no increase in risk in current users when former users (rather than nonusers) served as the reference group. That yielded an adjusted hazard ratio of 0.70.

The study cohort included participants aged 2 to 24 years in four large health plans. The investigators matched data from computerized health records to state death certificates and the National Death Index to identify serious cardiovascular events. They compared event rates in users of the ADHD drugs methylphenidate, dexmethylphenidate, dextroamphetamines, amphetamine salts, atomoxetine, and pemoline, and up to two nonuser controls subjects. In all, there were 3.1 serious cardiovascular events per 100,000 person-years.

The point estimates of the relative risks for ADHD drugs in this study did not indicate increased risk, but the upper limit of the 95% confidence interval suggested that a doubling in the risk could not be ruled out. However, several alternative analyses to test the robustness of the findings supported those of the primary analysis, the investigators explained, concluding that "the absolute magnitude of any increased risk would be low."

The Agency for Healthcare Research and Quality, the Department of Health and Human Services, and the Food and Drug Administration funded the study. Some authors reported disclosures other than grant funding from these organizations, including receiving grant funding or owning stock or stock options from various pharmaceutical companies.

The rate of hospitalization for heart failure in the United States declined approximately 30% between 1998 and 2008, according to a report in the Oct. 19 issue of JAMA.

This decrease is especially "remarkable" in light of the finding that survival after HF hospitalization also rose slightly at the same time, which means that there likely were more repeat hospitalizations for HF in any given year, said Dr. Jersey Chen of Yale University, New Haven, Conn., and his associates.

The researchers performed "the largest study to date examining trends in HF hospitalization rates across the United States" by analyzing a sample of 320,618,412 Medicare fee-for-service claims during that decade.

The overall risk-adjusted hospitalization rate decreased from 2,845 per 100,000 person-years to 2,007 per 100,000 person-years, a relative decline of 29.5%. In addition, the number of unique patients hospitalized at least once for HF in a given year dropped from 2,014 to 1,462 per 100,000 person-years.

This decrease represents an estimated savings of $4.1 billion in Medicare costs, the investigators said (JAMA 2011;306:1669-78).

Declines in HF hospitalization occurred across all age, sex, and race categories, although the amount of the decrease varied among these groups. For example, black men showed the lowest rate of decline among all categories of race and sex.

In addition, hospitalization for HF varied widely among the states. In 16 states, the decrease was significantly greater than the overall national decrease, while the decrease was significantly smaller in three states.

Dr. Chen and his colleagues also calculated 1-year mortality after HF hospitalization. Overall, this rate, adjusted for patient age, sex, race, and comorbidity, declined from 31.7% to 29.6%, a relative decrease of 6.6%.

The researchers characterized this reduction in HF mortality as "modest."

As with the hospitalization rates, the mortality rates varied substantially by state. Four states showed a more significant drop than the national average, and five showed a significant increase during the study period.

Such decreases were not found in previous studies of earlier time periods, such as the Framingham Heart Study, which examined trends in 1970-1999, and an Olmsted County (Minn.) study, which assessed trends in 1979-2004. "Our results may differ from these earlier studies because HF hospitalizations may have started to decline only recently," Dr. Chen and his associates noted.

Several more recent studies have indicated that HF hospitalization rates began to decline in the 1990s in Sweden, Scotland, Australia, and New Zealand, they added.

As an observational cohort study, this study was unable to determine the reasons for the marked decline in HF hospitalization and the more modest decline in HF mortality. However, the investigators speculated that improvements in underlying coronary artery disease, myocardial salvage after MI, and blood pressure control all may have played a role.

Improvements in secondary prevention also likely reduced HF exacerbations leading to hospitalization, including greater use of beta-blockers, ACE inhibitors, and angiotensin receptor blockers. In addition, clinical practice patterns may have changed, favoring outpatient rather than inpatient management of HF.

This study was limited in that it included only Medicare patients. "Trends in HF hospitalization and mortality may differ in younger patients with different types of insurance," Dr. Chen and his associates said.

The study was supported by the Agency for Healthcare Research and Quality and the National Heart, Lung, and Blood Institute. Dr. Chen’s associates reported ties to United Healthcare and Medtronic.

The rate of hospitalization for heart failure in the United States declined approximately 30% between 1998 and 2008, according to a report in the Oct. 19 issue of JAMA.

This decrease is especially "remarkable" in light of the finding that survival after HF hospitalization also rose slightly at the same time, which means that there likely were more repeat hospitalizations for HF in any given year, said Dr. Jersey Chen of Yale University, New Haven, Conn., and his associates.

The researchers performed "the largest study to date examining trends in HF hospitalization rates across the United States" by analyzing a sample of 320,618,412 Medicare fee-for-service claims during that decade.

The overall risk-adjusted hospitalization rate decreased from 2,845 per 100,000 person-years to 2,007 per 100,000 person-years, a relative decline of 29.5%. In addition, the number of unique patients hospitalized at least once for HF in a given year dropped from 2,014 to 1,462 per 100,000 person-years.

This decrease represents an estimated savings of $4.1 billion in Medicare costs, the investigators said (JAMA 2011;306:1669-78).

Declines in HF hospitalization occurred across all age, sex, and race categories, although the amount of the decrease varied among these groups. For example, black men showed the lowest rate of decline among all categories of race and sex.

In addition, hospitalization for HF varied widely among the states. In 16 states, the decrease was significantly greater than the overall national decrease, while the decrease was significantly smaller in three states.

Dr. Chen and his colleagues also calculated 1-year mortality after HF hospitalization. Overall, this rate, adjusted for patient age, sex, race, and comorbidity, declined from 31.7% to 29.6%, a relative decrease of 6.6%.

The researchers characterized this reduction in HF mortality as "modest."

As with the hospitalization rates, the mortality rates varied substantially by state. Four states showed a more significant drop than the national average, and five showed a significant increase during the study period.

Such decreases were not found in previous studies of earlier time periods, such as the Framingham Heart Study, which examined trends in 1970-1999, and an Olmsted County (Minn.) study, which assessed trends in 1979-2004. "Our results may differ from these earlier studies because HF hospitalizations may have started to decline only recently," Dr. Chen and his associates noted.

Several more recent studies have indicated that HF hospitalization rates began to decline in the 1990s in Sweden, Scotland, Australia, and New Zealand, they added.

As an observational cohort study, this study was unable to determine the reasons for the marked decline in HF hospitalization and the more modest decline in HF mortality. However, the investigators speculated that improvements in underlying coronary artery disease, myocardial salvage after MI, and blood pressure control all may have played a role.

Improvements in secondary prevention also likely reduced HF exacerbations leading to hospitalization, including greater use of beta-blockers, ACE inhibitors, and angiotensin receptor blockers. In addition, clinical practice patterns may have changed, favoring outpatient rather than inpatient management of HF.

This study was limited in that it included only Medicare patients. "Trends in HF hospitalization and mortality may differ in younger patients with different types of insurance," Dr. Chen and his associates said.

The study was supported by the Agency for Healthcare Research and Quality and the National Heart, Lung, and Blood Institute. Dr. Chen’s associates reported ties to United Healthcare and Medtronic.

The rate of hospitalization for heart failure in the United States declined approximately 30% between 1998 and 2008, according to a report in the Oct. 19 issue of JAMA.

This decrease is especially "remarkable" in light of the finding that survival after HF hospitalization also rose slightly at the same time, which means that there likely were more repeat hospitalizations for HF in any given year, said Dr. Jersey Chen of Yale University, New Haven, Conn., and his associates.

The researchers performed "the largest study to date examining trends in HF hospitalization rates across the United States" by analyzing a sample of 320,618,412 Medicare fee-for-service claims during that decade.

The overall risk-adjusted hospitalization rate decreased from 2,845 per 100,000 person-years to 2,007 per 100,000 person-years, a relative decline of 29.5%. In addition, the number of unique patients hospitalized at least once for HF in a given year dropped from 2,014 to 1,462 per 100,000 person-years.

This decrease represents an estimated savings of $4.1 billion in Medicare costs, the investigators said (JAMA 2011;306:1669-78).

Declines in HF hospitalization occurred across all age, sex, and race categories, although the amount of the decrease varied among these groups. For example, black men showed the lowest rate of decline among all categories of race and sex.

In addition, hospitalization for HF varied widely among the states. In 16 states, the decrease was significantly greater than the overall national decrease, while the decrease was significantly smaller in three states.

Dr. Chen and his colleagues also calculated 1-year mortality after HF hospitalization. Overall, this rate, adjusted for patient age, sex, race, and comorbidity, declined from 31.7% to 29.6%, a relative decrease of 6.6%.

The researchers characterized this reduction in HF mortality as "modest."

As with the hospitalization rates, the mortality rates varied substantially by state. Four states showed a more significant drop than the national average, and five showed a significant increase during the study period.

Such decreases were not found in previous studies of earlier time periods, such as the Framingham Heart Study, which examined trends in 1970-1999, and an Olmsted County (Minn.) study, which assessed trends in 1979-2004. "Our results may differ from these earlier studies because HF hospitalizations may have started to decline only recently," Dr. Chen and his associates noted.

Several more recent studies have indicated that HF hospitalization rates began to decline in the 1990s in Sweden, Scotland, Australia, and New Zealand, they added.

As an observational cohort study, this study was unable to determine the reasons for the marked decline in HF hospitalization and the more modest decline in HF mortality. However, the investigators speculated that improvements in underlying coronary artery disease, myocardial salvage after MI, and blood pressure control all may have played a role.

Improvements in secondary prevention also likely reduced HF exacerbations leading to hospitalization, including greater use of beta-blockers, ACE inhibitors, and angiotensin receptor blockers. In addition, clinical practice patterns may have changed, favoring outpatient rather than inpatient management of HF.

This study was limited in that it included only Medicare patients. "Trends in HF hospitalization and mortality may differ in younger patients with different types of insurance," Dr. Chen and his associates said.

The study was supported by the Agency for Healthcare Research and Quality and the National Heart, Lung, and Blood Institute. Dr. Chen’s associates reported ties to United Healthcare and Medtronic.

Most models currently used to predict hospital readmission risk perform poorly, and better approaches are needed as policy makers increasingly use hospital readmission rates to calculate and publicize quality of care comparison information.

Twenty-six different methods to calculate readmission risk were reviewed, yet only one model specifically addressed preventable readmissions, according to the study by Dr. Devan Kansagara of the Portland (Ore.) Veterans Affairs Medical Center and colleagues published in the Oct. 16 issue of JAMA. Meanwhile, most models performed poorly when used to predict readmission rates, regardless of whether they were developed to compare hospitals or to improve quality of care, the researchers said.

Still, several of these models are being used in clinical settings, in research projects, and for policy making. "Readmission risk prediction remains a poorly understood and complex endeavor," Dr. Kansagara said. "Although in certain settings such models may prove useful, better approaches are needed to assess hospital performance in discharging patients, as well as to identify patients at greater risk of avoidable readmission."

The analysis broke the models down into three groups: models relying on retrospective administrative data, models using real-time administrative data, and models incorporating primary data collection (JAMA 2001;306:1688-98).

In the group relying on retrospective administrative data, most of the 14 models studied included variables for medical comorbidity and use of prior medical services, while a few models also considered mental health, functional status, and other social variables, all of which may be important when determining readmission risk. All performed poorly except in specific subsets of patients; for example, one model was able to predict some readmissions in asthma patients, the researchers noted.

Three models attempted to identify high-risk patients during their initial hospitalizations in an effort to target them for interventions that might be able to prevent readmissions. Two of these – including a model implemented in one urban U.S. hospital to predict readmissions for heart failure – worked modestly well, especially in certain populations, but none had excellent predictive ability overall, the study said.

Finally, in the group of nine models that incorporated primary data collection, hospitals used questionnaires and other data in an effort to predict potential readmission risks early in patients’ initial hospital stays. Although several of these models had some predictive value, according to the study, none are in wide use, and a couple were developed more than 20 years ago.

Most of the models examined in the study included data on medical comorbidity, but few considered variables associated with illness severity, overall health and function, and socioeconomic factors that can affect a patient’s health, according to the study.

Public reporting of readmission rates, coupled with financial penalties for hospitals with high 30-day readmission rates, both are spurring organizations to implement quality improvement programs, Dr. Kansagara said. However, since the current available models for predicting readmission risk don’t work well, it may not be fair to use them to compare hospitals and possibly penalize them.

"Use of readmission rates as a quality metric assumes that readmissions are related to poor quality care and are potentially preventable," Dr. Kansagara said. "However, the preventability of readmissions remains unclear and understudied. We found only one validated prediction model that explicitly examined potentially preventable readmissions as an outcome, and it found that only about one-quarter of readmissions were clearly preventable."

The researchers noted that hospital and health system–level factors likely contribute to readmission risk, but are not included in any current models used to calculate readmission risk. For example, coordination with the patient’s primary care physician, plus the timing and frequency of postdischarge follow-up visits, can help determine if a patient will be readmitted or not, they said.

No conflicts of interest were reported. The study was supported by funding from the Department of Veterans Affairs and the National Institutes of Health.

Most models currently used to predict hospital readmission risk perform poorly, and better approaches are needed as policy makers increasingly use hospital readmission rates to calculate and publicize quality of care comparison information.

Twenty-six different methods to calculate readmission risk were reviewed, yet only one model specifically addressed preventable readmissions, according to the study by Dr. Devan Kansagara of the Portland (Ore.) Veterans Affairs Medical Center and colleagues published in the Oct. 16 issue of JAMA. Meanwhile, most models performed poorly when used to predict readmission rates, regardless of whether they were developed to compare hospitals or to improve quality of care, the researchers said.

Still, several of these models are being used in clinical settings, in research projects, and for policy making. "Readmission risk prediction remains a poorly understood and complex endeavor," Dr. Kansagara said. "Although in certain settings such models may prove useful, better approaches are needed to assess hospital performance in discharging patients, as well as to identify patients at greater risk of avoidable readmission."

The analysis broke the models down into three groups: models relying on retrospective administrative data, models using real-time administrative data, and models incorporating primary data collection (JAMA 2001;306:1688-98).

In the group relying on retrospective administrative data, most of the 14 models studied included variables for medical comorbidity and use of prior medical services, while a few models also considered mental health, functional status, and other social variables, all of which may be important when determining readmission risk. All performed poorly except in specific subsets of patients; for example, one model was able to predict some readmissions in asthma patients, the researchers noted.

Three models attempted to identify high-risk patients during their initial hospitalizations in an effort to target them for interventions that might be able to prevent readmissions. Two of these – including a model implemented in one urban U.S. hospital to predict readmissions for heart failure – worked modestly well, especially in certain populations, but none had excellent predictive ability overall, the study said.

Finally, in the group of nine models that incorporated primary data collection, hospitals used questionnaires and other data in an effort to predict potential readmission risks early in patients’ initial hospital stays. Although several of these models had some predictive value, according to the study, none are in wide use, and a couple were developed more than 20 years ago.

Most of the models examined in the study included data on medical comorbidity, but few considered variables associated with illness severity, overall health and function, and socioeconomic factors that can affect a patient’s health, according to the study.

Public reporting of readmission rates, coupled with financial penalties for hospitals with high 30-day readmission rates, both are spurring organizations to implement quality improvement programs, Dr. Kansagara said. However, since the current available models for predicting readmission risk don’t work well, it may not be fair to use them to compare hospitals and possibly penalize them.

"Use of readmission rates as a quality metric assumes that readmissions are related to poor quality care and are potentially preventable," Dr. Kansagara said. "However, the preventability of readmissions remains unclear and understudied. We found only one validated prediction model that explicitly examined potentially preventable readmissions as an outcome, and it found that only about one-quarter of readmissions were clearly preventable."

The researchers noted that hospital and health system–level factors likely contribute to readmission risk, but are not included in any current models used to calculate readmission risk. For example, coordination with the patient’s primary care physician, plus the timing and frequency of postdischarge follow-up visits, can help determine if a patient will be readmitted or not, they said.

No conflicts of interest were reported. The study was supported by funding from the Department of Veterans Affairs and the National Institutes of Health.

Most models currently used to predict hospital readmission risk perform poorly, and better approaches are needed as policy makers increasingly use hospital readmission rates to calculate and publicize quality of care comparison information.

Twenty-six different methods to calculate readmission risk were reviewed, yet only one model specifically addressed preventable readmissions, according to the study by Dr. Devan Kansagara of the Portland (Ore.) Veterans Affairs Medical Center and colleagues published in the Oct. 16 issue of JAMA. Meanwhile, most models performed poorly when used to predict readmission rates, regardless of whether they were developed to compare hospitals or to improve quality of care, the researchers said.

Still, several of these models are being used in clinical settings, in research projects, and for policy making. "Readmission risk prediction remains a poorly understood and complex endeavor," Dr. Kansagara said. "Although in certain settings such models may prove useful, better approaches are needed to assess hospital performance in discharging patients, as well as to identify patients at greater risk of avoidable readmission."

The analysis broke the models down into three groups: models relying on retrospective administrative data, models using real-time administrative data, and models incorporating primary data collection (JAMA 2001;306:1688-98).

In the group relying on retrospective administrative data, most of the 14 models studied included variables for medical comorbidity and use of prior medical services, while a few models also considered mental health, functional status, and other social variables, all of which may be important when determining readmission risk. All performed poorly except in specific subsets of patients; for example, one model was able to predict some readmissions in asthma patients, the researchers noted.

Three models attempted to identify high-risk patients during their initial hospitalizations in an effort to target them for interventions that might be able to prevent readmissions. Two of these – including a model implemented in one urban U.S. hospital to predict readmissions for heart failure – worked modestly well, especially in certain populations, but none had excellent predictive ability overall, the study said.

Finally, in the group of nine models that incorporated primary data collection, hospitals used questionnaires and other data in an effort to predict potential readmission risks early in patients’ initial hospital stays. Although several of these models had some predictive value, according to the study, none are in wide use, and a couple were developed more than 20 years ago.

Most of the models examined in the study included data on medical comorbidity, but few considered variables associated with illness severity, overall health and function, and socioeconomic factors that can affect a patient’s health, according to the study.

Public reporting of readmission rates, coupled with financial penalties for hospitals with high 30-day readmission rates, both are spurring organizations to implement quality improvement programs, Dr. Kansagara said. However, since the current available models for predicting readmission risk don’t work well, it may not be fair to use them to compare hospitals and possibly penalize them.

"Use of readmission rates as a quality metric assumes that readmissions are related to poor quality care and are potentially preventable," Dr. Kansagara said. "However, the preventability of readmissions remains unclear and understudied. We found only one validated prediction model that explicitly examined potentially preventable readmissions as an outcome, and it found that only about one-quarter of readmissions were clearly preventable."

The researchers noted that hospital and health system–level factors likely contribute to readmission risk, but are not included in any current models used to calculate readmission risk. For example, coordination with the patient’s primary care physician, plus the timing and frequency of postdischarge follow-up visits, can help determine if a patient will be readmitted or not, they said.

No conflicts of interest were reported. The study was supported by funding from the Department of Veterans Affairs and the National Institutes of Health.

Just the mention of code status to patients and their families often turns a (sometimes feined) upbeat demeanor into a solemn one. While the mere mention of even a remote possibility of dying understandably makes patients uncomfortable and introspective, the lack of truly understanding the significance of the code status is potentially catastrophic. So teaching our patients the true significance of a DNR order is vital.

It seems as if just about everyone knows or has heard of someone who was inhumanely kept alive far too long, all the while suffering needlessly as a "vegetable." So, naturally, when asked if they would want to be resuscitated should their heart or lungs show signs of giving out, many people quickly answer with a resounding "No!", while others point out that they have an advance directive, not realizing that this legal document is not the appropriate option in all situations. But as physicians, we know that a 3 a.m. run of ventricular tachycardia in a generally healthy woman admitted with severe diarrhea and dehydration may simply be the result of an easy-to-correct electrolyte abnormality, and not an indicator that her heart is giving out.

I have had countless conversations with patients and their family members about code status, and I find it very unfortunate that the general public is so poorly informed on this issue.

I remember a gentleman in his 50s who declared himself a DNR in the ER, not realizing the implications. When I subsequently saw him and explained to him that in many situations, a person’s condition can be completely turned around with appropriate treatment, he changed his mind and revoked his DNR status. Within a few hours, his oxygen saturation plummeted as a result of his pneumonia, and he required intubation. He had no other significant medical problems, and he did very well. Had he not revoked his DNR status, he likely would have succumbed to pneumonia in the hospital. Instead, he was eventually discharged home to go back to his normal life.

Though our workflow is often hectic, taking a few minutes to confirm that patients really understand what a DNR order means, as well as understand the difference between an advance directive and a DNR order, can literally save lives.

Dr. A. Maria Hester is a hospitalist with Baltimore Washington Medical Center, Glen Burnie, Md., who has a passion for empowering patients to partner in their health care.

Just the mention of code status to patients and their families often turns a (sometimes feined) upbeat demeanor into a solemn one. While the mere mention of even a remote possibility of dying understandably makes patients uncomfortable and introspective, the lack of truly understanding the significance of the code status is potentially catastrophic. So teaching our patients the true significance of a DNR order is vital.

It seems as if just about everyone knows or has heard of someone who was inhumanely kept alive far too long, all the while suffering needlessly as a "vegetable." So, naturally, when asked if they would want to be resuscitated should their heart or lungs show signs of giving out, many people quickly answer with a resounding "No!", while others point out that they have an advance directive, not realizing that this legal document is not the appropriate option in all situations. But as physicians, we know that a 3 a.m. run of ventricular tachycardia in a generally healthy woman admitted with severe diarrhea and dehydration may simply be the result of an easy-to-correct electrolyte abnormality, and not an indicator that her heart is giving out.

I have had countless conversations with patients and their family members about code status, and I find it very unfortunate that the general public is so poorly informed on this issue.

I remember a gentleman in his 50s who declared himself a DNR in the ER, not realizing the implications. When I subsequently saw him and explained to him that in many situations, a person’s condition can be completely turned around with appropriate treatment, he changed his mind and revoked his DNR status. Within a few hours, his oxygen saturation plummeted as a result of his pneumonia, and he required intubation. He had no other significant medical problems, and he did very well. Had he not revoked his DNR status, he likely would have succumbed to pneumonia in the hospital. Instead, he was eventually discharged home to go back to his normal life.

Though our workflow is often hectic, taking a few minutes to confirm that patients really understand what a DNR order means, as well as understand the difference between an advance directive and a DNR order, can literally save lives.

Dr. A. Maria Hester is a hospitalist with Baltimore Washington Medical Center, Glen Burnie, Md., who has a passion for empowering patients to partner in their health care.

Just the mention of code status to patients and their families often turns a (sometimes feined) upbeat demeanor into a solemn one. While the mere mention of even a remote possibility of dying understandably makes patients uncomfortable and introspective, the lack of truly understanding the significance of the code status is potentially catastrophic. So teaching our patients the true significance of a DNR order is vital.

It seems as if just about everyone knows or has heard of someone who was inhumanely kept alive far too long, all the while suffering needlessly as a "vegetable." So, naturally, when asked if they would want to be resuscitated should their heart or lungs show signs of giving out, many people quickly answer with a resounding "No!", while others point out that they have an advance directive, not realizing that this legal document is not the appropriate option in all situations. But as physicians, we know that a 3 a.m. run of ventricular tachycardia in a generally healthy woman admitted with severe diarrhea and dehydration may simply be the result of an easy-to-correct electrolyte abnormality, and not an indicator that her heart is giving out.

I have had countless conversations with patients and their family members about code status, and I find it very unfortunate that the general public is so poorly informed on this issue.

I remember a gentleman in his 50s who declared himself a DNR in the ER, not realizing the implications. When I subsequently saw him and explained to him that in many situations, a person’s condition can be completely turned around with appropriate treatment, he changed his mind and revoked his DNR status. Within a few hours, his oxygen saturation plummeted as a result of his pneumonia, and he required intubation. He had no other significant medical problems, and he did very well. Had he not revoked his DNR status, he likely would have succumbed to pneumonia in the hospital. Instead, he was eventually discharged home to go back to his normal life.

Though our workflow is often hectic, taking a few minutes to confirm that patients really understand what a DNR order means, as well as understand the difference between an advance directive and a DNR order, can literally save lives.

Dr. A. Maria Hester is a hospitalist with Baltimore Washington Medical Center, Glen Burnie, Md., who has a passion for empowering patients to partner in their health care.

PARIS – The heart rate lowering agent, ivabradine, significantly improved left ventricular volume indexes and left ventricular ejection fraction in patients with heart failure and systolic dysfunction, according to the findings of an echocardiography substudy of a large randomized controlled trial.

"These results suggest that ivabradine modifies disease progression in patients with heart failure receiving background therapy," Dr. Jean-Claude Tardif said at the annual congress of the European Society of Cardiology. The results are also clinically important because left ventricular enlargement and reduced ejection fraction are powerful predictors of outcomes in heart failure.

Notably, among the 411 patients analyzed, those who had the greatest reduction in heart rate had better remodeling and outcomes.

Investigators reported at last year’s congress that in SHIFT (Systolic Heart Failure Treatment With the I_f Inhibitor Ivabradine Trial), ivabradine (Procoralan), a selective I_f channel blocker, led to an 18% reduction in the composite primary end point of cardiovascular death and heart failure hospitalization, compared with placebo, in 6,558 patients with chronic heart failure, a left ventricular ejection fraction (LVEF) of 35% or less, and resting heart rate of at least 70 beats per minute (Lancet 2010;376:875-85).

In the prespecified substudy, echocardiography was used to assess left ventricular modeling in 208 patients treated with ivabradine, 5 mg twice daily, and 203 patients given placebo. Baseline background treatment included beta-blockers (92%), an ACE inhibitor/angiotensin-receptor blocker (96%), or an aldosterone antagonist (72%). Their mean LVEF was 32%.

Eight months of treatment with ivabradine resulted in a statistically significant 7 mL/m² reduction in the primary end point of left ventricular end-systolic volume index (LVESVI), compared with a 0.9 mL/m² reduction in the placebo group (P = .0002), reported Dr. Tardif, with the Montreal Heart Institute at the University of Montreal. The change in LVESVI was independent of beta-blocker use, heart failure etiology and baseline LVEF.

A reduction in LVESVI of at least 15% was observed in significantly more patients with ivabradine than placebo (38% vs. 25%, P = .005)

Ivabradine significantly improved the secondary end points of left ventricular end-diastolic volume index (-7.9 mL/m² vs. -1.8 mL/m², P = .002) and LVEF (2.4% vs. -0.1%, P = .0003), he said.

Significantly more patients experienced a clinically relevant improvement in LVEF of 5% or more with ivabradine than placebo (36% vs. 23%, P = .003).

"The significant reductions in LV volumes in favor of ivabradine were parallel with the reduction in heart rate at eight months achieved with ivabradine versus placebo [-14.7 bpm vs. -5.8 bpm, P less than .0001]," Dr. Tardif said.

Discussant Dr. Burkert Pieske, with the division of cardiology at the Medical University of Graz (Austria), said that the substudy findings underscore the importance of reverse remodeling as a marker for improved outcome, and provides solid, mechanistic data to encourage the use of ivabradine as an add-on medication in patients in sinus rhythm and a heart rate above 7 beats/minute.

"The reduction in LVESVI of about 6 mL/m² is more or less comparable with other pharmacologic interventions, and importantly it adds on to the beneficial effect of beta blockers and ACE inhibitors," he said.

In contrast to cardiac resynchronization, ivabradine can be started by every heart failure physician without great expense, Dr. Pieske and his colleague Dr. Friedrich Fruhwald, wrote in an accompanying editorial in the European Heart Journal (Eur. Heart J. 2011 Sept. 2 [doi:10.1093/eurheartj/ehr317]).

They pointed out, however, that ivabradine only works in heart failure patients with sinus rhythm and that relevant reverse modeling was seen in only a third of these patients.

"So, we have to identify the right patients we need to treat with ivabradine," said Dr. Pieske, adding that further testing is warranted in such conditions as acute heart failure or heart failure with preserved ejection fraction.

Findings from a second SHIFT substudy suggest that reduction in heart rate with ivabradine is associated with improved health-related quality of life.

At 12 months, the change from baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score was significantly greater in the ivabradine group than the placebo group (6.7 vs. 4.3, P less than .001).

This also was true for the KCCQ clinical summary score (5.0 vs. 3.3, P = .018), reported Dr. Inger Ekman from the Institute of Health Care Sciences, Sahlgrenska Academy in Gothenburg, Sweden. A change of 5 units is considered a clinically meaningful change in KCCQ scoring.

The magnitude of heart rate reduction with ivabradine was directly related to the degree of improvement in health-related quality of life, she said.

Among the 1,944 patients in the substudy, the incidence of cardiovascular death or heart failure hospitalization at 12 months was inversely associated with KCCQ scores.

Dr. Ekman pointed out that recommended therapies with survival benefits like beta blockers have no impact on health-related quality of life, while some therapies that improve quality of life like inotropic agents do not improve survival.

Dr. Tardif and Dr. Ekman reported that all the study’s authors have received fees, research grants or both from the study sponsor, Servier. Dr. Pieske reported having no relevant disclosures.

PARIS – The heart rate lowering agent, ivabradine, significantly improved left ventricular volume indexes and left ventricular ejection fraction in patients with heart failure and systolic dysfunction, according to the findings of an echocardiography substudy of a large randomized controlled trial.

"These results suggest that ivabradine modifies disease progression in patients with heart failure receiving background therapy," Dr. Jean-Claude Tardif said at the annual congress of the European Society of Cardiology. The results are also clinically important because left ventricular enlargement and reduced ejection fraction are powerful predictors of outcomes in heart failure.

Notably, among the 411 patients analyzed, those who had the greatest reduction in heart rate had better remodeling and outcomes.

Investigators reported at last year’s congress that in SHIFT (Systolic Heart Failure Treatment With the I_f Inhibitor Ivabradine Trial), ivabradine (Procoralan), a selective I_f channel blocker, led to an 18% reduction in the composite primary end point of cardiovascular death and heart failure hospitalization, compared with placebo, in 6,558 patients with chronic heart failure, a left ventricular ejection fraction (LVEF) of 35% or less, and resting heart rate of at least 70 beats per minute (Lancet 2010;376:875-85).

In the prespecified substudy, echocardiography was used to assess left ventricular modeling in 208 patients treated with ivabradine, 5 mg twice daily, and 203 patients given placebo. Baseline background treatment included beta-blockers (92%), an ACE inhibitor/angiotensin-receptor blocker (96%), or an aldosterone antagonist (72%). Their mean LVEF was 32%.

Eight months of treatment with ivabradine resulted in a statistically significant 7 mL/m² reduction in the primary end point of left ventricular end-systolic volume index (LVESVI), compared with a 0.9 mL/m² reduction in the placebo group (P = .0002), reported Dr. Tardif, with the Montreal Heart Institute at the University of Montreal. The change in LVESVI was independent of beta-blocker use, heart failure etiology and baseline LVEF.

A reduction in LVESVI of at least 15% was observed in significantly more patients with ivabradine than placebo (38% vs. 25%, P = .005)

Ivabradine significantly improved the secondary end points of left ventricular end-diastolic volume index (-7.9 mL/m² vs. -1.8 mL/m², P = .002) and LVEF (2.4% vs. -0.1%, P = .0003), he said.

Significantly more patients experienced a clinically relevant improvement in LVEF of 5% or more with ivabradine than placebo (36% vs. 23%, P = .003).

"The significant reductions in LV volumes in favor of ivabradine were parallel with the reduction in heart rate at eight months achieved with ivabradine versus placebo [-14.7 bpm vs. -5.8 bpm, P less than .0001]," Dr. Tardif said.

Discussant Dr. Burkert Pieske, with the division of cardiology at the Medical University of Graz (Austria), said that the substudy findings underscore the importance of reverse remodeling as a marker for improved outcome, and provides solid, mechanistic data to encourage the use of ivabradine as an add-on medication in patients in sinus rhythm and a heart rate above 7 beats/minute.

"The reduction in LVESVI of about 6 mL/m² is more or less comparable with other pharmacologic interventions, and importantly it adds on to the beneficial effect of beta blockers and ACE inhibitors," he said.

In contrast to cardiac resynchronization, ivabradine can be started by every heart failure physician without great expense, Dr. Pieske and his colleague Dr. Friedrich Fruhwald, wrote in an accompanying editorial in the European Heart Journal (Eur. Heart J. 2011 Sept. 2 [doi:10.1093/eurheartj/ehr317]).

They pointed out, however, that ivabradine only works in heart failure patients with sinus rhythm and that relevant reverse modeling was seen in only a third of these patients.

"So, we have to identify the right patients we need to treat with ivabradine," said Dr. Pieske, adding that further testing is warranted in such conditions as acute heart failure or heart failure with preserved ejection fraction.

Findings from a second SHIFT substudy suggest that reduction in heart rate with ivabradine is associated with improved health-related quality of life.

At 12 months, the change from baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score was significantly greater in the ivabradine group than the placebo group (6.7 vs. 4.3, P less than .001).

This also was true for the KCCQ clinical summary score (5.0 vs. 3.3, P = .018), reported Dr. Inger Ekman from the Institute of Health Care Sciences, Sahlgrenska Academy in Gothenburg, Sweden. A change of 5 units is considered a clinically meaningful change in KCCQ scoring.

The magnitude of heart rate reduction with ivabradine was directly related to the degree of improvement in health-related quality of life, she said.

Among the 1,944 patients in the substudy, the incidence of cardiovascular death or heart failure hospitalization at 12 months was inversely associated with KCCQ scores.

Dr. Ekman pointed out that recommended therapies with survival benefits like beta blockers have no impact on health-related quality of life, while some therapies that improve quality of life like inotropic agents do not improve survival.

Dr. Tardif and Dr. Ekman reported that all the study’s authors have received fees, research grants or both from the study sponsor, Servier. Dr. Pieske reported having no relevant disclosures.

PARIS – The heart rate lowering agent, ivabradine, significantly improved left ventricular volume indexes and left ventricular ejection fraction in patients with heart failure and systolic dysfunction, according to the findings of an echocardiography substudy of a large randomized controlled trial.

"These results suggest that ivabradine modifies disease progression in patients with heart failure receiving background therapy," Dr. Jean-Claude Tardif said at the annual congress of the European Society of Cardiology. The results are also clinically important because left ventricular enlargement and reduced ejection fraction are powerful predictors of outcomes in heart failure.

Notably, among the 411 patients analyzed, those who had the greatest reduction in heart rate had better remodeling and outcomes.

Investigators reported at last year’s congress that in SHIFT (Systolic Heart Failure Treatment With the I_f Inhibitor Ivabradine Trial), ivabradine (Procoralan), a selective I_f channel blocker, led to an 18% reduction in the composite primary end point of cardiovascular death and heart failure hospitalization, compared with placebo, in 6,558 patients with chronic heart failure, a left ventricular ejection fraction (LVEF) of 35% or less, and resting heart rate of at least 70 beats per minute (Lancet 2010;376:875-85).

In the prespecified substudy, echocardiography was used to assess left ventricular modeling in 208 patients treated with ivabradine, 5 mg twice daily, and 203 patients given placebo. Baseline background treatment included beta-blockers (92%), an ACE inhibitor/angiotensin-receptor blocker (96%), or an aldosterone antagonist (72%). Their mean LVEF was 32%.

Eight months of treatment with ivabradine resulted in a statistically significant 7 mL/m² reduction in the primary end point of left ventricular end-systolic volume index (LVESVI), compared with a 0.9 mL/m² reduction in the placebo group (P = .0002), reported Dr. Tardif, with the Montreal Heart Institute at the University of Montreal. The change in LVESVI was independent of beta-blocker use, heart failure etiology and baseline LVEF.

A reduction in LVESVI of at least 15% was observed in significantly more patients with ivabradine than placebo (38% vs. 25%, P = .005)

Ivabradine significantly improved the secondary end points of left ventricular end-diastolic volume index (-7.9 mL/m² vs. -1.8 mL/m², P = .002) and LVEF (2.4% vs. -0.1%, P = .0003), he said.

Significantly more patients experienced a clinically relevant improvement in LVEF of 5% or more with ivabradine than placebo (36% vs. 23%, P = .003).

"The significant reductions in LV volumes in favor of ivabradine were parallel with the reduction in heart rate at eight months achieved with ivabradine versus placebo [-14.7 bpm vs. -5.8 bpm, P less than .0001]," Dr. Tardif said.

Discussant Dr. Burkert Pieske, with the division of cardiology at the Medical University of Graz (Austria), said that the substudy findings underscore the importance of reverse remodeling as a marker for improved outcome, and provides solid, mechanistic data to encourage the use of ivabradine as an add-on medication in patients in sinus rhythm and a heart rate above 7 beats/minute.

"The reduction in LVESVI of about 6 mL/m² is more or less comparable with other pharmacologic interventions, and importantly it adds on to the beneficial effect of beta blockers and ACE inhibitors," he said.

In contrast to cardiac resynchronization, ivabradine can be started by every heart failure physician without great expense, Dr. Pieske and his colleague Dr. Friedrich Fruhwald, wrote in an accompanying editorial in the European Heart Journal (Eur. Heart J. 2011 Sept. 2 [doi:10.1093/eurheartj/ehr317]).

They pointed out, however, that ivabradine only works in heart failure patients with sinus rhythm and that relevant reverse modeling was seen in only a third of these patients.

"So, we have to identify the right patients we need to treat with ivabradine," said Dr. Pieske, adding that further testing is warranted in such conditions as acute heart failure or heart failure with preserved ejection fraction.

Findings from a second SHIFT substudy suggest that reduction in heart rate with ivabradine is associated with improved health-related quality of life.

At 12 months, the change from baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score was significantly greater in the ivabradine group than the placebo group (6.7 vs. 4.3, P less than .001).

This also was true for the KCCQ clinical summary score (5.0 vs. 3.3, P = .018), reported Dr. Inger Ekman from the Institute of Health Care Sciences, Sahlgrenska Academy in Gothenburg, Sweden. A change of 5 units is considered a clinically meaningful change in KCCQ scoring.

The magnitude of heart rate reduction with ivabradine was directly related to the degree of improvement in health-related quality of life, she said.

Among the 1,944 patients in the substudy, the incidence of cardiovascular death or heart failure hospitalization at 12 months was inversely associated with KCCQ scores.

Dr. Ekman pointed out that recommended therapies with survival benefits like beta blockers have no impact on health-related quality of life, while some therapies that improve quality of life like inotropic agents do not improve survival.

Dr. Tardif and Dr. Ekman reported that all the study’s authors have received fees, research grants or both from the study sponsor, Servier. Dr. Pieske reported having no relevant disclosures.

PARIS – Worse long-term outcomes after high-emergency heart transplants in patients bridged to transplant with cardiac assist devices seem to be related to more complex transplant procedures for those patients rather than differences in patients or donors, a registry study suggests.

The study compared data on 107 patients who had been supported with short-term ventricular assist devices (VADs) and 597 patients supported with conventional therapy before high-emergency heart transplantation (defined by United Network for Organ Sharing status 1 criteria). Data came from 15 centers in the Spanish National Heart Transplant Registry in 2000-2009.

In the postoperative period, rates of primary graft failure and major bleeding were higher among VAD patients than among the conventional group (39% vs. 22%, and 33% vs. 23%, respectively). Furthermore, 22% in the VAD group and 14% in the conventional group required cardiac reoperation. These differences between groups were statistically significant, Dr. Eduardo Barge-Caballero and his associates reported in a press briefing at the annual congress of the European Society of Cardiology.

There was a trend toward higher risk of in-hospital death after surgery in the VAD group (36%) compared with the conventional group (27%), but this did not reach statistical significance. Approximately 60% of patients in the VAD group survived a year after transplantation compared with about 70% of patients in the conventional group.

Long-term survival rates differed significantly between groups by the first year after heart transplantation after adjustment for confounding variables, but the differences were not significant at 10 years of follow-up, said Dr. Barge-Caballero of Hospital Universitario A Coruña, Spain.

Concerns about potential adverse impacts of short-term VAD on outcomes after high-emergency heart transplantation have been cited previously. It has been suggested that these adverse impacts may have been caused by the VAD patients being in worse clinical condition, undergoing more difficult procedures with bleeding complications and infections caused by removal of the VAD, receiving less-desirable donor hearts, or being at a higher risk of rejection.

The current study, which compared the clinical characteristics of donor hearts and recipients in the VAD and conventional groups, concluded that donors were similar between groups and recipients were "not drastically different" between groups, Dr. Barge-Caballero said.

Two kinds of VADs were implanted: Forty-nine patients got extracorporeal continuous-flow devices, and 58 patients received paracorporeal pulsatile-flow devices. There was a trend toward a higher risk of bleeding with the paracorporeal pulsatile-flow devices, but there were not enough patients in each group to show a significant difference, he said.

Patients supported by VAD were significantly younger than were those receiving conventional bridge therapy (48 vs. 51 years, respectively) and were more likely to be female (37% vs. 17%) and to have had previous cardiac surgery (53% vs. 20%). Before VAD implantation, patients in the VAD group received higher doses of intravenous inotropes than did patients in the conventional group.

Measures of end-organ function such as creatinine and bilirubin were similar between groups. Donor organs were similar between groups in age, cold ischemia time, and other characteristics.

The surgical bypass time was significantly longer in the VAD group (156 minutes) than in the conventional group (133 minutes), which may reflect more complicated heart transplantation surgery in the VAD group, he suggested.

Patients spent a mean of only 5 days on bridge support with VAD or conventional bridge therapy, including intra-aortic balloon pump and/or IV inotropes, invasive mechanical ventilation, and dialysis.

Stable patients awaiting high-emergency heart transplantation in countries with short waiting lists should not routinely get VADs, Dr. Barge-Caballero suggested. Because of their risks, VADs should be reserved for critically ill patients who deteriorate when conventional therapy does not provide adequate peripheral perfusion to avoid irreversible end-organ damage.

"Routine implantation of a short-term VAD is not a good option for all patients undergoing a high-emergency heart transplantation," Dr. Barge-Caballero said. "It’s evident that if the patient is really not doing well, has severe hemodynamic instability, [and] is not well with conventional support, we have to implant a VAD. But it’s not, in our opinion, a good option for all patients."

Dr. Barge-Caballero said the investigators had no relevant conflicts of interest.

PARIS – Worse long-term outcomes after high-emergency heart transplants in patients bridged to transplant with cardiac assist devices seem to be related to more complex transplant procedures for those patients rather than differences in patients or donors, a registry study suggests.

The study compared data on 107 patients who had been supported with short-term ventricular assist devices (VADs) and 597 patients supported with conventional therapy before high-emergency heart transplantation (defined by United Network for Organ Sharing status 1 criteria). Data came from 15 centers in the Spanish National Heart Transplant Registry in 2000-2009.

In the postoperative period, rates of primary graft failure and major bleeding were higher among VAD patients than among the conventional group (39% vs. 22%, and 33% vs. 23%, respectively). Furthermore, 22% in the VAD group and 14% in the conventional group required cardiac reoperation. These differences between groups were statistically significant, Dr. Eduardo Barge-Caballero and his associates reported in a press briefing at the annual congress of the European Society of Cardiology.

There was a trend toward higher risk of in-hospital death after surgery in the VAD group (36%) compared with the conventional group (27%), but this did not reach statistical significance. Approximately 60% of patients in the VAD group survived a year after transplantation compared with about 70% of patients in the conventional group.

Long-term survival rates differed significantly between groups by the first year after heart transplantation after adjustment for confounding variables, but the differences were not significant at 10 years of follow-up, said Dr. Barge-Caballero of Hospital Universitario A Coruña, Spain.

Concerns about potential adverse impacts of short-term VAD on outcomes after high-emergency heart transplantation have been cited previously. It has been suggested that these adverse impacts may have been caused by the VAD patients being in worse clinical condition, undergoing more difficult procedures with bleeding complications and infections caused by removal of the VAD, receiving less-desirable donor hearts, or being at a higher risk of rejection.

The current study, which compared the clinical characteristics of donor hearts and recipients in the VAD and conventional groups, concluded that donors were similar between groups and recipients were "not drastically different" between groups, Dr. Barge-Caballero said.

Two kinds of VADs were implanted: Forty-nine patients got extracorporeal continuous-flow devices, and 58 patients received paracorporeal pulsatile-flow devices. There was a trend toward a higher risk of bleeding with the paracorporeal pulsatile-flow devices, but there were not enough patients in each group to show a significant difference, he said.

Patients supported by VAD were significantly younger than were those receiving conventional bridge therapy (48 vs. 51 years, respectively) and were more likely to be female (37% vs. 17%) and to have had previous cardiac surgery (53% vs. 20%). Before VAD implantation, patients in the VAD group received higher doses of intravenous inotropes than did patients in the conventional group.

Measures of end-organ function such as creatinine and bilirubin were similar between groups. Donor organs were similar between groups in age, cold ischemia time, and other characteristics.

The surgical bypass time was significantly longer in the VAD group (156 minutes) than in the conventional group (133 minutes), which may reflect more complicated heart transplantation surgery in the VAD group, he suggested.

Patients spent a mean of only 5 days on bridge support with VAD or conventional bridge therapy, including intra-aortic balloon pump and/or IV inotropes, invasive mechanical ventilation, and dialysis.

Stable patients awaiting high-emergency heart transplantation in countries with short waiting lists should not routinely get VADs, Dr. Barge-Caballero suggested. Because of their risks, VADs should be reserved for critically ill patients who deteriorate when conventional therapy does not provide adequate peripheral perfusion to avoid irreversible end-organ damage.

"Routine implantation of a short-term VAD is not a good option for all patients undergoing a high-emergency heart transplantation," Dr. Barge-Caballero said. "It’s evident that if the patient is really not doing well, has severe hemodynamic instability, [and] is not well with conventional support, we have to implant a VAD. But it’s not, in our opinion, a good option for all patients."

Dr. Barge-Caballero said the investigators had no relevant conflicts of interest.

PARIS – Worse long-term outcomes after high-emergency heart transplants in patients bridged to transplant with cardiac assist devices seem to be related to more complex transplant procedures for those patients rather than differences in patients or donors, a registry study suggests.

The study compared data on 107 patients who had been supported with short-term ventricular assist devices (VADs) and 597 patients supported with conventional therapy before high-emergency heart transplantation (defined by United Network for Organ Sharing status 1 criteria). Data came from 15 centers in the Spanish National Heart Transplant Registry in 2000-2009.

In the postoperative period, rates of primary graft failure and major bleeding were higher among VAD patients than among the conventional group (39% vs. 22%, and 33% vs. 23%, respectively). Furthermore, 22% in the VAD group and 14% in the conventional group required cardiac reoperation. These differences between groups were statistically significant, Dr. Eduardo Barge-Caballero and his associates reported in a press briefing at the annual congress of the European Society of Cardiology.

There was a trend toward higher risk of in-hospital death after surgery in the VAD group (36%) compared with the conventional group (27%), but this did not reach statistical significance. Approximately 60% of patients in the VAD group survived a year after transplantation compared with about 70% of patients in the conventional group.

Long-term survival rates differed significantly between groups by the first year after heart transplantation after adjustment for confounding variables, but the differences were not significant at 10 years of follow-up, said Dr. Barge-Caballero of Hospital Universitario A Coruña, Spain.

Concerns about potential adverse impacts of short-term VAD on outcomes after high-emergency heart transplantation have been cited previously. It has been suggested that these adverse impacts may have been caused by the VAD patients being in worse clinical condition, undergoing more difficult procedures with bleeding complications and infections caused by removal of the VAD, receiving less-desirable donor hearts, or being at a higher risk of rejection.

The current study, which compared the clinical characteristics of donor hearts and recipients in the VAD and conventional groups, concluded that donors were similar between groups and recipients were "not drastically different" between groups, Dr. Barge-Caballero said.

Two kinds of VADs were implanted: Forty-nine patients got extracorporeal continuous-flow devices, and 58 patients received paracorporeal pulsatile-flow devices. There was a trend toward a higher risk of bleeding with the paracorporeal pulsatile-flow devices, but there were not enough patients in each group to show a significant difference, he said.

Patients supported by VAD were significantly younger than were those receiving conventional bridge therapy (48 vs. 51 years, respectively) and were more likely to be female (37% vs. 17%) and to have had previous cardiac surgery (53% vs. 20%). Before VAD implantation, patients in the VAD group received higher doses of intravenous inotropes than did patients in the conventional group.

Measures of end-organ function such as creatinine and bilirubin were similar between groups. Donor organs were similar between groups in age, cold ischemia time, and other characteristics.

The surgical bypass time was significantly longer in the VAD group (156 minutes) than in the conventional group (133 minutes), which may reflect more complicated heart transplantation surgery in the VAD group, he suggested.

Patients spent a mean of only 5 days on bridge support with VAD or conventional bridge therapy, including intra-aortic balloon pump and/or IV inotropes, invasive mechanical ventilation, and dialysis.

Stable patients awaiting high-emergency heart transplantation in countries with short waiting lists should not routinely get VADs, Dr. Barge-Caballero suggested. Because of their risks, VADs should be reserved for critically ill patients who deteriorate when conventional therapy does not provide adequate peripheral perfusion to avoid irreversible end-organ damage.

"Routine implantation of a short-term VAD is not a good option for all patients undergoing a high-emergency heart transplantation," Dr. Barge-Caballero said. "It’s evident that if the patient is really not doing well, has severe hemodynamic instability, [and] is not well with conventional support, we have to implant a VAD. But it’s not, in our opinion, a good option for all patients."

Dr. Barge-Caballero said the investigators had no relevant conflicts of interest.

Major Finding: Among patients with diabetes who took eplerenone, there was a 46% reduction in the primary end point of death from cardiovascular causes or heart failure hospitalization, compared with those who took placebo.

Data Source: Subanalysis of high-risk groups and follow-up analyses of the phase III EMPHASIS-HF trial.

Disclosures: Pfizer sponsored the trial. Dr. Pitt reports financial relationships with several firms excluding Pfizer. His coauthors report similar relationships including employment with Pfizer.

PARIS – The aldosterone antagonist eplerenone cut cardiovascular events and the need for hospitalization significantly across all risk levels in patients with mild heart failure, according to a subanalysis of the EMPHASIS-HF trial.

Eplerenone (Inspra) was also shown to trim troublesome and costly repeat heart failure hospitalizations in a subset of patients followed for up to 10 additional months after the pivotal, phase III trial closed, Dr. Bertram Pitt reported at the congress.

“Overall efficacy, no matter where we looked, was about the same, and we had the same safety,” he told reporters.

EMPHASIS-HF (Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure) was stopped prematurely last spring after eplerenone in addition to standard therapy demonstrated a 37% (hazard ratio, 0.63) improvement over placebo in the primary end point of death from cardiovascular causes or heart failure hospitalization in 2,637 patients with mild New York Heart Association class II systolic heart failure (N. Engl. J. Med. 2011;364:11-21).

Among 1,597 patients who remained on double-blind therapy after study, the primary end point occurred in 21% on eplerenone and 29% on placebo (HR, 0.66), a significant difference, said Dr. Pitt of the University of Michigan, Ann Arbor.

Repeat hospitalization for heart failure was significantly reduced with eplerenone (rate ratio, 0.62).

“This suggests, to us at least, that this is going to have important cost implications and quality of life implications, as well as important implications on survival, since we know that heart failure hospitalization relates to target-organ damage and survival,” he said.

The benefits of eplerenone were particularly compelling in elderly patients and those with diabetes and renal dysfunction, three high-risk populations in whom clinicians are hesitant to use adjuvant aldosterone blockade because of fears of inducing hyperkalemia, Dr. Pitt said. He pointed out that recent head-to-head data show that the aldosterone antagonist spironolactone (Aldactone) raises hemoglobin A1_c and cortisol levels and reduces adiponectin in patients with diabetes, whereas eplerenone does not.

When Dr. Pitt and colleagues looked at patients with diabetes in the subanalysis, the benefit was stronger than that observed in the overall EMPHASIS-HF cohort, with a 46% reduction in the primary end point (HR, 0.54).

Dr. Pitt noted that the current American Heart Association, American College of Cardiology and European Society of Cardiology guidelines for aldosterone blockade do not specify a particular agent, but look at the agents as a class.

“We believe with [these] data, that in the next guidelines there should at least be some consideration for the specific use of eplerenone, at least in the subset of patients with diabetes,” he said.

Among patients with an estimated glomerular filtration rate less than 60 mL per minute per 1.73 m

The study excluded patients with a baseline serum potassium level above 5.0 mmol/L and estimated GFR below 30 mL per minute per 1.73 m

Among elderly patients at least 75 years old, the benefit on the primary end point with eplerenone reached 34%.

Significant benefits were also observed in patients with a left ventricular ejection fraction less than 30% and with a median systolic blood pressure of less than 123 mm Hg.

As seen in the overall EMPHASIS-HF cohort, the benefits of eplerenone were accompanied by a significant increase in the incidence of serum potassium greater than 5.5 mmol/L in each of the high-risk subgroups.

However, there were no significant increases in the incidence of serum potassium above 6 mmol/L, hospitalization leading to treatment discontinuation, hospitalization for/or deaths due to hyperkalemia, or hospitalizations for worsening renal function, Dr. Pitt said.

Invited discussant Dr. Piotr Ponikowski, with the 4th Military Hospital in Wroclaw, Poland, highlighted as important the benefits of eplerenone in people with diabetes and the reduction in repeat hospitalizations. He noted that up to 50% of heart failure patients are rehospitalized and these visits are associated with significant costs and reduced quality of life and mortality. Still, aldosterone antagonists remain underutilized in heart failure patients in Europe as well as the United States.

Physicians frequently question whether clinical trial data are real, consistent, and clinically meaningful, he said. “With the presented data, we can now say that the answer to all these questions is 'yes.'”

View a video interview with Dr. Pitt with the QR code, or by visiting ecardiologynews.com

This is going to have important implications in terms of cost, quality of life, and survival.

Source DR. PITT

Major Finding: Among patients with diabetes who took eplerenone, there was a 46% reduction in the primary end point of death from cardiovascular causes or heart failure hospitalization, compared with those who took placebo.

Data Source: Subanalysis of high-risk groups and follow-up analyses of the phase III EMPHASIS-HF trial.

Disclosures: Pfizer sponsored the trial. Dr. Pitt reports financial relationships with several firms excluding Pfizer. His coauthors report similar relationships including employment with Pfizer.

PARIS – The aldosterone antagonist eplerenone cut cardiovascular events and the need for hospitalization significantly across all risk levels in patients with mild heart failure, according to a subanalysis of the EMPHASIS-HF trial.

Eplerenone (Inspra) was also shown to trim troublesome and costly repeat heart failure hospitalizations in a subset of patients followed for up to 10 additional months after the pivotal, phase III trial closed, Dr. Bertram Pitt reported at the congress.

“Overall efficacy, no matter where we looked, was about the same, and we had the same safety,” he told reporters.

EMPHASIS-HF (Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure) was stopped prematurely last spring after eplerenone in addition to standard therapy demonstrated a 37% (hazard ratio, 0.63) improvement over placebo in the primary end point of death from cardiovascular causes or heart failure hospitalization in 2,637 patients with mild New York Heart Association class II systolic heart failure (N. Engl. J. Med. 2011;364:11-21).

Among 1,597 patients who remained on double-blind therapy after study, the primary end point occurred in 21% on eplerenone and 29% on placebo (HR, 0.66), a significant difference, said Dr. Pitt of the University of Michigan, Ann Arbor.

Repeat hospitalization for heart failure was significantly reduced with eplerenone (rate ratio, 0.62).

“This suggests, to us at least, that this is going to have important cost implications and quality of life implications, as well as important implications on survival, since we know that heart failure hospitalization relates to target-organ damage and survival,” he said.

The benefits of eplerenone were particularly compelling in elderly patients and those with diabetes and renal dysfunction, three high-risk populations in whom clinicians are hesitant to use adjuvant aldosterone blockade because of fears of inducing hyperkalemia, Dr. Pitt said. He pointed out that recent head-to-head data show that the aldosterone antagonist spironolactone (Aldactone) raises hemoglobin A1_c and cortisol levels and reduces adiponectin in patients with diabetes, whereas eplerenone does not.

When Dr. Pitt and colleagues looked at patients with diabetes in the subanalysis, the benefit was stronger than that observed in the overall EMPHASIS-HF cohort, with a 46% reduction in the primary end point (HR, 0.54).

Dr. Pitt noted that the current American Heart Association, American College of Cardiology and European Society of Cardiology guidelines for aldosterone blockade do not specify a particular agent, but look at the agents as a class.

“We believe with [these] data, that in the next guidelines there should at least be some consideration for the specific use of eplerenone, at least in the subset of patients with diabetes,” he said.

Among patients with an estimated glomerular filtration rate less than 60 mL per minute per 1.73 m

The study excluded patients with a baseline serum potassium level above 5.0 mmol/L and estimated GFR below 30 mL per minute per 1.73 m

Among elderly patients at least 75 years old, the benefit on the primary end point with eplerenone reached 34%.

Significant benefits were also observed in patients with a left ventricular ejection fraction less than 30% and with a median systolic blood pressure of less than 123 mm Hg.

As seen in the overall EMPHASIS-HF cohort, the benefits of eplerenone were accompanied by a significant increase in the incidence of serum potassium greater than 5.5 mmol/L in each of the high-risk subgroups.

However, there were no significant increases in the incidence of serum potassium above 6 mmol/L, hospitalization leading to treatment discontinuation, hospitalization for/or deaths due to hyperkalemia, or hospitalizations for worsening renal function, Dr. Pitt said.

Invited discussant Dr. Piotr Ponikowski, with the 4th Military Hospital in Wroclaw, Poland, highlighted as important the benefits of eplerenone in people with diabetes and the reduction in repeat hospitalizations. He noted that up to 50% of heart failure patients are rehospitalized and these visits are associated with significant costs and reduced quality of life and mortality. Still, aldosterone antagonists remain underutilized in heart failure patients in Europe as well as the United States.

Physicians frequently question whether clinical trial data are real, consistent, and clinically meaningful, he said. “With the presented data, we can now say that the answer to all these questions is 'yes.'”

View a video interview with Dr. Pitt with the QR code, or by visiting ecardiologynews.com

This is going to have important implications in terms of cost, quality of life, and survival.

Source DR. PITT

Major Finding: Among patients with diabetes who took eplerenone, there was a 46% reduction in the primary end point of death from cardiovascular causes or heart failure hospitalization, compared with those who took placebo.

Data Source: Subanalysis of high-risk groups and follow-up analyses of the phase III EMPHASIS-HF trial.

Disclosures: Pfizer sponsored the trial. Dr. Pitt reports financial relationships with several firms excluding Pfizer. His coauthors report similar relationships including employment with Pfizer.

PARIS – The aldosterone antagonist eplerenone cut cardiovascular events and the need for hospitalization significantly across all risk levels in patients with mild heart failure, according to a subanalysis of the EMPHASIS-HF trial.

Eplerenone (Inspra) was also shown to trim troublesome and costly repeat heart failure hospitalizations in a subset of patients followed for up to 10 additional months after the pivotal, phase III trial closed, Dr. Bertram Pitt reported at the congress.

“Overall efficacy, no matter where we looked, was about the same, and we had the same safety,” he told reporters.

EMPHASIS-HF (Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure) was stopped prematurely last spring after eplerenone in addition to standard therapy demonstrated a 37% (hazard ratio, 0.63) improvement over placebo in the primary end point of death from cardiovascular causes or heart failure hospitalization in 2,637 patients with mild New York Heart Association class II systolic heart failure (N. Engl. J. Med. 2011;364:11-21).

Among 1,597 patients who remained on double-blind therapy after study, the primary end point occurred in 21% on eplerenone and 29% on placebo (HR, 0.66), a significant difference, said Dr. Pitt of the University of Michigan, Ann Arbor.

Repeat hospitalization for heart failure was significantly reduced with eplerenone (rate ratio, 0.62).

“This suggests, to us at least, that this is going to have important cost implications and quality of life implications, as well as important implications on survival, since we know that heart failure hospitalization relates to target-organ damage and survival,” he said.

The benefits of eplerenone were particularly compelling in elderly patients and those with diabetes and renal dysfunction, three high-risk populations in whom clinicians are hesitant to use adjuvant aldosterone blockade because of fears of inducing hyperkalemia, Dr. Pitt said. He pointed out that recent head-to-head data show that the aldosterone antagonist spironolactone (Aldactone) raises hemoglobin A1_c and cortisol levels and reduces adiponectin in patients with diabetes, whereas eplerenone does not.

When Dr. Pitt and colleagues looked at patients with diabetes in the subanalysis, the benefit was stronger than that observed in the overall EMPHASIS-HF cohort, with a 46% reduction in the primary end point (HR, 0.54).

Dr. Pitt noted that the current American Heart Association, American College of Cardiology and European Society of Cardiology guidelines for aldosterone blockade do not specify a particular agent, but look at the agents as a class.

“We believe with [these] data, that in the next guidelines there should at least be some consideration for the specific use of eplerenone, at least in the subset of patients with diabetes,” he said.

Among patients with an estimated glomerular filtration rate less than 60 mL per minute per 1.73 m

The study excluded patients with a baseline serum potassium level above 5.0 mmol/L and estimated GFR below 30 mL per minute per 1.73 m

Among elderly patients at least 75 years old, the benefit on the primary end point with eplerenone reached 34%.

Significant benefits were also observed in patients with a left ventricular ejection fraction less than 30% and with a median systolic blood pressure of less than 123 mm Hg.

As seen in the overall EMPHASIS-HF cohort, the benefits of eplerenone were accompanied by a significant increase in the incidence of serum potassium greater than 5.5 mmol/L in each of the high-risk subgroups.

However, there were no significant increases in the incidence of serum potassium above 6 mmol/L, hospitalization leading to treatment discontinuation, hospitalization for/or deaths due to hyperkalemia, or hospitalizations for worsening renal function, Dr. Pitt said.

Invited discussant Dr. Piotr Ponikowski, with the 4th Military Hospital in Wroclaw, Poland, highlighted as important the benefits of eplerenone in people with diabetes and the reduction in repeat hospitalizations. He noted that up to 50% of heart failure patients are rehospitalized and these visits are associated with significant costs and reduced quality of life and mortality. Still, aldosterone antagonists remain underutilized in heart failure patients in Europe as well as the United States.

Physicians frequently question whether clinical trial data are real, consistent, and clinically meaningful, he said. “With the presented data, we can now say that the answer to all these questions is 'yes.'”

View a video interview with Dr. Pitt with the QR code, or by visiting ecardiologynews.com

This is going to have important implications in terms of cost, quality of life, and survival.

Source DR. PITT

SAN DIEGO – Heart failure constitutes a previously unrecognized independent risk factor for major osteoporotic fractures, according to a Canadian cohort study.

"Patients with heart failure have double the 5-year risk of fracture," compared with those without heart failure. And "patients with heart failure have lower bone mineral density at every skeletal site at the time of their first test," compared with those without heart failure. "Finally, neither differences in bone mass nor shared risk factors [are enough] to explain the increased risk," said Dr. Sumit Majumdar at the annual meeting of the American Society for Bone and Mineral Research.

He presented a population-based cohort study that included all Manitobans older than age 50 years who had their first bone mineral density test in 1998-2009. The study earned him the 2011 ASBMR Most Outstanding Clinical Abstract Award.

Overall, 4% of the nearly 46,000 Manitobans who had an initial bone minteral density (BMD) test during the study years were identified as having recent-onset heart failure (that is, heart failure diagnosed within the previous 2 years). There were 2,703 new fractures in the study population during a median 5 years of follow-up. The recent heart failure group had a 10% incidence of major nontraumatic fractures of the upper extremities, vertebrae, and hip during the 5 years following the first BMD test, compared with a 5% incidence in subjects without heart failure.

The median time to first fracture in the heart failure group was 3.6 years. The curves describing fracture incidence started to diverge soon after the first BMD test and continued to widen throughout the maximum 10 years of follow-up, reported Dr. Majumdar, professor of general internal medicine at the University of Alberta, Edmonton.

Patients with heart failure had more of all the standard risk factors for osteoporosis (except weight) than did subjects without heart failure. They were significantly older (mean age, 74 vs. 66 years) and 21% of them had a prior major osteoporotic fracture, compared with 13% of those without heart failure. Some 12% of heart failure patients had been on systemic corticosteroids for longer than 90 days, compared with 4% of those without heart failure.

Moreover, 40% of heart failure patients had osteoporosis at the time of their first BMD measurement (defined as a T score less than –2.5 at any skeletal site), compared with 29% of individuals without heart failure. T scores were significantly lower in the heart failure group at all measured sites.

"A diagnosis of heart failure portends an increased risk of fracture greater than rheumatoid arthritis or prior fracture."

On the other hand, nearly every medication used in treating heart failure has previously been shown to increase BMD and to reduce fracture risk, with the exception of loop diuretics, which reduce BMD.

In addition, osteoporosis and heart failure are common, chronic conditions that share several etiologic risk factors, including older age, postmenopausal status, diabetes, and smoking, he continued.

The unadjusted risk of a major osteoporotic fracture was increased 2.45-fold in patients with heart failure. But upon adjustment in a multivariate analysis for nearly 30 potential confounders including age, sex, osteoporosis-related factors, medications, comorbidities, and total hip BMD, heart failure remained independently associated with a highly significant 28% increased risk of major osteoporotic fractures.

A disturbing finding of the study was that a mere 14% of heart failure patients who experienced an osteoporotic fracture were then placed on a bisphosphonate or other bone-protective therapy. Bisphosphonates had no association with mortality in the heart failure group.

"For clinicians, I think our study means we need to start understanding that a diagnosis of heart failure portends an increased risk of fracture greater than rheumatoid arthritis or prior fracture, in our data. And we need to learn that patients with heart failure are easily diagnosed and need much more attention to their bone health," Dr. Majumdar observed.

This study also opens up research opportunities for bench scientists, as the Manitoba database contains no information on patients’ aldosterone, parathyroid hormone, or vitamin D levels, or indeed on any other variables that might provide a mechanistic explanation for the link between heart failure and osteoporotic fractures.

"Ours is an example of bedside-to-bench research," he said.

In that vein, one audience member noted that increased adrenergic drive is a hallmark of heart failure. He wondered if heart failure patients on beta-blocker therapy had a lower fracture risk. Dr. Majumdar replied that he and his coinvestigators had had the same thought. However, when they specifically compared the nearly 35% of heart failure patients who were on a beta-blocker vs. those who weren’t, they found that fracture rates in the two groups weren’t significantly different.

Dr. Majumdar declared having no relevant financial interests.

SAN DIEGO – Heart failure constitutes a previously unrecognized independent risk factor for major osteoporotic fractures, according to a Canadian cohort study.

"Patients with heart failure have double the 5-year risk of fracture," compared with those without heart failure. And "patients with heart failure have lower bone mineral density at every skeletal site at the time of their first test," compared with those without heart failure. "Finally, neither differences in bone mass nor shared risk factors [are enough] to explain the increased risk," said Dr. Sumit Majumdar at the annual meeting of the American Society for Bone and Mineral Research.

He presented a population-based cohort study that included all Manitobans older than age 50 years who had their first bone mineral density test in 1998-2009. The study earned him the 2011 ASBMR Most Outstanding Clinical Abstract Award.

Overall, 4% of the nearly 46,000 Manitobans who had an initial bone minteral density (BMD) test during the study years were identified as having recent-onset heart failure (that is, heart failure diagnosed within the previous 2 years). There were 2,703 new fractures in the study population during a median 5 years of follow-up. The recent heart failure group had a 10% incidence of major nontraumatic fractures of the upper extremities, vertebrae, and hip during the 5 years following the first BMD test, compared with a 5% incidence in subjects without heart failure.

The median time to first fracture in the heart failure group was 3.6 years. The curves describing fracture incidence started to diverge soon after the first BMD test and continued to widen throughout the maximum 10 years of follow-up, reported Dr. Majumdar, professor of general internal medicine at the University of Alberta, Edmonton.

Patients with heart failure had more of all the standard risk factors for osteoporosis (except weight) than did subjects without heart failure. They were significantly older (mean age, 74 vs. 66 years) and 21% of them had a prior major osteoporotic fracture, compared with 13% of those without heart failure. Some 12% of heart failure patients had been on systemic corticosteroids for longer than 90 days, compared with 4% of those without heart failure.

Moreover, 40% of heart failure patients had osteoporosis at the time of their first BMD measurement (defined as a T score less than –2.5 at any skeletal site), compared with 29% of individuals without heart failure. T scores were significantly lower in the heart failure group at all measured sites.

"A diagnosis of heart failure portends an increased risk of fracture greater than rheumatoid arthritis or prior fracture."

On the other hand, nearly every medication used in treating heart failure has previously been shown to increase BMD and to reduce fracture risk, with the exception of loop diuretics, which reduce BMD.

In addition, osteoporosis and heart failure are common, chronic conditions that share several etiologic risk factors, including older age, postmenopausal status, diabetes, and smoking, he continued.

The unadjusted risk of a major osteoporotic fracture was increased 2.45-fold in patients with heart failure. But upon adjustment in a multivariate analysis for nearly 30 potential confounders including age, sex, osteoporosis-related factors, medications, comorbidities, and total hip BMD, heart failure remained independently associated with a highly significant 28% increased risk of major osteoporotic fractures.

A disturbing finding of the study was that a mere 14% of heart failure patients who experienced an osteoporotic fracture were then placed on a bisphosphonate or other bone-protective therapy. Bisphosphonates had no association with mortality in the heart failure group.

"For clinicians, I think our study means we need to start understanding that a diagnosis of heart failure portends an increased risk of fracture greater than rheumatoid arthritis or prior fracture, in our data. And we need to learn that patients with heart failure are easily diagnosed and need much more attention to their bone health," Dr. Majumdar observed.

This study also opens up research opportunities for bench scientists, as the Manitoba database contains no information on patients’ aldosterone, parathyroid hormone, or vitamin D levels, or indeed on any other variables that might provide a mechanistic explanation for the link between heart failure and osteoporotic fractures.

"Ours is an example of bedside-to-bench research," he said.

In that vein, one audience member noted that increased adrenergic drive is a hallmark of heart failure. He wondered if heart failure patients on beta-blocker therapy had a lower fracture risk. Dr. Majumdar replied that he and his coinvestigators had had the same thought. However, when they specifically compared the nearly 35% of heart failure patients who were on a beta-blocker vs. those who weren’t, they found that fracture rates in the two groups weren’t significantly different.

Dr. Majumdar declared having no relevant financial interests.

SAN DIEGO – Heart failure constitutes a previously unrecognized independent risk factor for major osteoporotic fractures, according to a Canadian cohort study.

"Patients with heart failure have double the 5-year risk of fracture," compared with those without heart failure. And "patients with heart failure have lower bone mineral density at every skeletal site at the time of their first test," compared with those without heart failure. "Finally, neither differences in bone mass nor shared risk factors [are enough] to explain the increased risk," said Dr. Sumit Majumdar at the annual meeting of the American Society for Bone and Mineral Research.

He presented a population-based cohort study that included all Manitobans older than age 50 years who had their first bone mineral density test in 1998-2009. The study earned him the 2011 ASBMR Most Outstanding Clinical Abstract Award.

Overall, 4% of the nearly 46,000 Manitobans who had an initial bone minteral density (BMD) test during the study years were identified as having recent-onset heart failure (that is, heart failure diagnosed within the previous 2 years). There were 2,703 new fractures in the study population during a median 5 years of follow-up. The recent heart failure group had a 10% incidence of major nontraumatic fractures of the upper extremities, vertebrae, and hip during the 5 years following the first BMD test, compared with a 5% incidence in subjects without heart failure.

The median time to first fracture in the heart failure group was 3.6 years. The curves describing fracture incidence started to diverge soon after the first BMD test and continued to widen throughout the maximum 10 years of follow-up, reported Dr. Majumdar, professor of general internal medicine at the University of Alberta, Edmonton.

Patients with heart failure had more of all the standard risk factors for osteoporosis (except weight) than did subjects without heart failure. They were significantly older (mean age, 74 vs. 66 years) and 21% of them had a prior major osteoporotic fracture, compared with 13% of those without heart failure. Some 12% of heart failure patients had been on systemic corticosteroids for longer than 90 days, compared with 4% of those without heart failure.

Moreover, 40% of heart failure patients had osteoporosis at the time of their first BMD measurement (defined as a T score less than –2.5 at any skeletal site), compared with 29% of individuals without heart failure. T scores were significantly lower in the heart failure group at all measured sites.

"A diagnosis of heart failure portends an increased risk of fracture greater than rheumatoid arthritis or prior fracture."

On the other hand, nearly every medication used in treating heart failure has previously been shown to increase BMD and to reduce fracture risk, with the exception of loop diuretics, which reduce BMD.

In addition, osteoporosis and heart failure are common, chronic conditions that share several etiologic risk factors, including older age, postmenopausal status, diabetes, and smoking, he continued.

The unadjusted risk of a major osteoporotic fracture was increased 2.45-fold in patients with heart failure. But upon adjustment in a multivariate analysis for nearly 30 potential confounders including age, sex, osteoporosis-related factors, medications, comorbidities, and total hip BMD, heart failure remained independently associated with a highly significant 28% increased risk of major osteoporotic fractures.

A disturbing finding of the study was that a mere 14% of heart failure patients who experienced an osteoporotic fracture were then placed on a bisphosphonate or other bone-protective therapy. Bisphosphonates had no association with mortality in the heart failure group.

"For clinicians, I think our study means we need to start understanding that a diagnosis of heart failure portends an increased risk of fracture greater than rheumatoid arthritis or prior fracture, in our data. And we need to learn that patients with heart failure are easily diagnosed and need much more attention to their bone health," Dr. Majumdar observed.

This study also opens up research opportunities for bench scientists, as the Manitoba database contains no information on patients’ aldosterone, parathyroid hormone, or vitamin D levels, or indeed on any other variables that might provide a mechanistic explanation for the link between heart failure and osteoporotic fractures.

"Ours is an example of bedside-to-bench research," he said.

In that vein, one audience member noted that increased adrenergic drive is a hallmark of heart failure. He wondered if heart failure patients on beta-blocker therapy had a lower fracture risk. Dr. Majumdar replied that he and his coinvestigators had had the same thought. However, when they specifically compared the nearly 35% of heart failure patients who were on a beta-blocker vs. those who weren’t, they found that fracture rates in the two groups weren’t significantly different.

Dr. Majumdar declared having no relevant financial interests.

Many hospitals may be unprepared for a new Medicare requirement to lower readmissions, and could face resulting financial penalties over the next few years, according to a new report from the Dartmouth Atlas Project.

Over a 5-year period, hospitals made little progress in reducing readmissions among Medicare beneficiaries aged 65 years and older. The Dartmouth Atlas researchers found that surgical 30-day readmission rates were 12.7% in both 2004 and 2009, and medical 30-day readmission rates rose from 15.9% in 2004 to 16.1% in 2009.

They found similar trends when they looked at specific conditions. For example, the national readmission rates for hip fractures were 14.3% in 2004, compared with 14.5% in 2009. The rates were also relatively unchanged for congestive heart failure (20.9% vs. 21.2%) and pneumonia (15.1% vs. 15.3%). However, U.S. hospitals showed some improvement in acute myocardial infarctions, reducing 30-day readmissions from 19.4% in 2004 to 18.5% in 2009.

"For a long-standing and well-recognized problem, not much progress has been made," Dr. David C. Goodman, the study’s lead author and director of the Center for Health Policy Research at the Dartmouth Institute for Health Policy and Clinical Practice, said during a press conference to release the findings.

The researchers analyzed data for fee-for-service Medicare beneficiaries aged 65 years and older who lived in 306 Dartmouth Atlas hospital referral regions and had both Part A and Part B Medicare coverage.

Hospital readmissions have garnered significant attention in the health care community since the passage of the Affordable Care Act. The new health law calls on the Centers for Medicare and Medicaid Services to start measuring 30-day hospital readmission rates and to penalize poor performers. In October 2012, hospitals with high readmission rates will face penalties of 1% of their total Medicare billings. The penalty increases to 2% the following year.

Part of the solution to reducing hospital readmissions is good discharge planning, Dr. Goodman said. "This sounds simple but often doesn’t happen."

That planning should include having the care team in the hospital develop a care plan and communicate that plan to the patient and their family. It also means ensuring that the patient has all the necessary prescriptions, understands what medications to take and when, and can get their prescriptions. And health care providers in the hospital should also help patients set up follow-up appointments with their primary care physician, Dr. Goodman said.

But aside from discharge planning, there are also "hidden" factors such as how local patterns of hospital use affect readmission rates. Dr. Goodman and his colleagues found that communities and health care systems with higher underlying admission rates also tended to have higher rates of hospital readmission.

The Dartmouth Atlas Project receives most of its funding from the Robert Wood Johnson Foundation, the National Institute on Aging, the California Healthcare Foundation, the United Healthcare Foundation, and the WellPoint Foundation. The researchers reported no financial conflicts.

Many hospitals may be unprepared for a new Medicare requirement to lower readmissions, and could face resulting financial penalties over the next few years, according to a new report from the Dartmouth Atlas Project.

Over a 5-year period, hospitals made little progress in reducing readmissions among Medicare beneficiaries aged 65 years and older. The Dartmouth Atlas researchers found that surgical 30-day readmission rates were 12.7% in both 2004 and 2009, and medical 30-day readmission rates rose from 15.9% in 2004 to 16.1% in 2009.

They found similar trends when they looked at specific conditions. For example, the national readmission rates for hip fractures were 14.3% in 2004, compared with 14.5% in 2009. The rates were also relatively unchanged for congestive heart failure (20.9% vs. 21.2%) and pneumonia (15.1% vs. 15.3%). However, U.S. hospitals showed some improvement in acute myocardial infarctions, reducing 30-day readmissions from 19.4% in 2004 to 18.5% in 2009.

"For a long-standing and well-recognized problem, not much progress has been made," Dr. David C. Goodman, the study’s lead author and director of the Center for Health Policy Research at the Dartmouth Institute for Health Policy and Clinical Practice, said during a press conference to release the findings.

The researchers analyzed data for fee-for-service Medicare beneficiaries aged 65 years and older who lived in 306 Dartmouth Atlas hospital referral regions and had both Part A and Part B Medicare coverage.

Hospital readmissions have garnered significant attention in the health care community since the passage of the Affordable Care Act. The new health law calls on the Centers for Medicare and Medicaid Services to start measuring 30-day hospital readmission rates and to penalize poor performers. In October 2012, hospitals with high readmission rates will face penalties of 1% of their total Medicare billings. The penalty increases to 2% the following year.

Part of the solution to reducing hospital readmissions is good discharge planning, Dr. Goodman said. "This sounds simple but often doesn’t happen."

That planning should include having the care team in the hospital develop a care plan and communicate that plan to the patient and their family. It also means ensuring that the patient has all the necessary prescriptions, understands what medications to take and when, and can get their prescriptions. And health care providers in the hospital should also help patients set up follow-up appointments with their primary care physician, Dr. Goodman said.

But aside from discharge planning, there are also "hidden" factors such as how local patterns of hospital use affect readmission rates. Dr. Goodman and his colleagues found that communities and health care systems with higher underlying admission rates also tended to have higher rates of hospital readmission.

The Dartmouth Atlas Project receives most of its funding from the Robert Wood Johnson Foundation, the National Institute on Aging, the California Healthcare Foundation, the United Healthcare Foundation, and the WellPoint Foundation. The researchers reported no financial conflicts.

Many hospitals may be unprepared for a new Medicare requirement to lower readmissions, and could face resulting financial penalties over the next few years, according to a new report from the Dartmouth Atlas Project.

Over a 5-year period, hospitals made little progress in reducing readmissions among Medicare beneficiaries aged 65 years and older. The Dartmouth Atlas researchers found that surgical 30-day readmission rates were 12.7% in both 2004 and 2009, and medical 30-day readmission rates rose from 15.9% in 2004 to 16.1% in 2009.

They found similar trends when they looked at specific conditions. For example, the national readmission rates for hip fractures were 14.3% in 2004, compared with 14.5% in 2009. The rates were also relatively unchanged for congestive heart failure (20.9% vs. 21.2%) and pneumonia (15.1% vs. 15.3%). However, U.S. hospitals showed some improvement in acute myocardial infarctions, reducing 30-day readmissions from 19.4% in 2004 to 18.5% in 2009.

"For a long-standing and well-recognized problem, not much progress has been made," Dr. David C. Goodman, the study’s lead author and director of the Center for Health Policy Research at the Dartmouth Institute for Health Policy and Clinical Practice, said during a press conference to release the findings.

The researchers analyzed data for fee-for-service Medicare beneficiaries aged 65 years and older who lived in 306 Dartmouth Atlas hospital referral regions and had both Part A and Part B Medicare coverage.

Hospital readmissions have garnered significant attention in the health care community since the passage of the Affordable Care Act. The new health law calls on the Centers for Medicare and Medicaid Services to start measuring 30-day hospital readmission rates and to penalize poor performers. In October 2012, hospitals with high readmission rates will face penalties of 1% of their total Medicare billings. The penalty increases to 2% the following year.

Part of the solution to reducing hospital readmissions is good discharge planning, Dr. Goodman said. "This sounds simple but often doesn’t happen."

That planning should include having the care team in the hospital develop a care plan and communicate that plan to the patient and their family. It also means ensuring that the patient has all the necessary prescriptions, understands what medications to take and when, and can get their prescriptions. And health care providers in the hospital should also help patients set up follow-up appointments with their primary care physician, Dr. Goodman said.

But aside from discharge planning, there are also "hidden" factors such as how local patterns of hospital use affect readmission rates. Dr. Goodman and his colleagues found that communities and health care systems with higher underlying admission rates also tended to have higher rates of hospital readmission.

The Dartmouth Atlas Project receives most of its funding from the Robert Wood Johnson Foundation, the National Institute on Aging, the California Healthcare Foundation, the United Healthcare Foundation, and the WellPoint Foundation. The researchers reported no financial conflicts.