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OA-related walking disability on par with diabetes as CVD risk factor
PARIS – Greater walking disability is an independent predictor of all-cause death and major cardiovascular events in patients with symptomatic hip or knee osteoarthritis, according to a population-based study that confirms previous research.
For the composite cardiovascular disease (CVD) outcome of hospitalization for angina, acute myocardial infarction, coronary revascularization, congestive heart failure, stroke, or transient ischemic attack, the risk associated with a Health Assessment Questionnaire (HAQ) walking disability score of 2 was the same as that of diabetes and pre-existing CVD.
Total joint replacement reduced those risks by about 40%, Dr. Gillian A. Hawker said at the World Congress on Osteoarthritis (OA).
"I think the key piece here is that these data at least suggest that walking disability is a cardiovascular risk factor similar to diabetes," she said. "When we’re talking about risk assessment for cardiovascular outcomes, which everyone does pretty routinely in medicine, walking disability, which is really osteoarthritis, is one of the risk factors that they should be assessing ... If we can just start asking, hopefully it will get us thinking about, ‘Wow, this person has OA,’ and we need to start assessing it."
Session comoderator Ana M. Valdes, Ph.D., of the University of Nottingham (England) commented that the results are fascinating because this is not the first study to identify these associations. In 2011, British investigators reported that all-cause mortality, particularly due to CVD causes, was significantly related to baseline walking disability in patients with knee or hip OA (Br. Med. J. 2011;342:d1165).
"One of the things that happens often with OA is that it’s seen as just pain and if we can give them plenty of relief, they’ll be OK, but it’s actually life-threatening because if we do not address their disability, they are at risk of dying," Dr. Valdes said in an interview. "I think this should be put on the front pages of the weekly medical journals, so that people are aware of the dangers of not treating osteoarthritis properly."
Comorbidity is a barrier to OA care, and 90% of those aged 65 years and older with OA have at least one other chronic condition, such as diabetes and heart disease, observed Dr. Hawker, professor of medicine at the University of Toronto and physician-in-chief of medicine, Women’s College Hospital in Toronto.
Her group reported in a separate presentation at the meeting that walking disability also raises the risk for diabetes complications in those with both OA and diabetes.
For the current population-based study, the investigators linked provincial health administrative databases to baseline surveys from a population cohort of 2,156 patients with symptomatic moderate to severe OA who were recruited in 1996-1998 through a screening survey in Ontario.
Their mean age was 71 years (all were 55 years or older), 72% were female, 34% obese, 20% had diabetes, and 40% had prebaseline CVD. Their average HAQ walking disability score was 2 on a 3-point scale, and they had a mean WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) summary score of 41. Overall, 44% used a walking aid. (A walking disability score of 2 corresponds with walking outdoors on flat ground with much difficulty, whereas a score of 3 means the person is unable to do it.)
After a median follow-up period of 13.2 years, 57% of patients had died, and 38% experienced the composite CVD outcome with a median of 9.2 years follow-up.
In multivariable analysis, there was a very clear dose-response, where increased walking disability was associated with increasing risk of all-cause death, Dr. Hawker said. The adjusted hazard ratio per unit increase in HAQ walking score was 1.30 (P less than .001), after controlling for confounders including age, sex, preexisting CVD, diabetes, hypertension, body mass index, and smoking status.
A HAQ walking score of 2 was associated with an adjusted hazard ratio of 1.69, which was actually greater than that associated with preexisting cardiovascular disease or diabetes, she said.
For the composite CVD outcome, there was also a significant association with HAQ walking score (adjusted HR, 1.17; P = .001).
Sensitivity analyses performed in 402 patients (18%) receiving postbaseline total joint arthroplasty (TJA ) showed that controlling for TJA did not change the effect of baseline disability but was protective for both all-cause death (HR, 0.62; P less than .001) and CVD events (HR, 0.66; P less than .001), Dr. Hawker said at the meeting sponsored by the Osteoarthritis Research Society International.
Although the data were not dichotomized, she noted that there was "beautiful discrimination" when they looked at the outcomes based on whether or not patients used a walking aid.
"Obviously, it’s nice to see a dose-response, but simply knowing that someone’s using a walking aid and getting them to the point where they’ve got improved walking ability, could go a long way," she said.
Though the study was not designed to address potential mechanisms, Dr. Hawker said she’s long argued that physical activity and mobility are a key player of downstream effects on fitness, blood pressure, glucose control, and ability to participate in self-management activities and physician visits. The potential role for pain, mood, and stress also can not be excluded.
One audience member asked whether walking disability may be a "cheap and dirty version" of the stress test.
Dr. Hawker responded that walking disability is a proxy for a lot of things and is definitely OA-related, adding, "Yes, I think it is a very cheap and dirty stress test. It’s a lovely thing that if we focused more explicitly on it in randomized trials, for instance as a primary outcome, or in rehabilitation strategies, it would have global benefit."
The authors reported no competing interests.
PARIS – Greater walking disability is an independent predictor of all-cause death and major cardiovascular events in patients with symptomatic hip or knee osteoarthritis, according to a population-based study that confirms previous research.
For the composite cardiovascular disease (CVD) outcome of hospitalization for angina, acute myocardial infarction, coronary revascularization, congestive heart failure, stroke, or transient ischemic attack, the risk associated with a Health Assessment Questionnaire (HAQ) walking disability score of 2 was the same as that of diabetes and pre-existing CVD.
Total joint replacement reduced those risks by about 40%, Dr. Gillian A. Hawker said at the World Congress on Osteoarthritis (OA).
"I think the key piece here is that these data at least suggest that walking disability is a cardiovascular risk factor similar to diabetes," she said. "When we’re talking about risk assessment for cardiovascular outcomes, which everyone does pretty routinely in medicine, walking disability, which is really osteoarthritis, is one of the risk factors that they should be assessing ... If we can just start asking, hopefully it will get us thinking about, ‘Wow, this person has OA,’ and we need to start assessing it."
Session comoderator Ana M. Valdes, Ph.D., of the University of Nottingham (England) commented that the results are fascinating because this is not the first study to identify these associations. In 2011, British investigators reported that all-cause mortality, particularly due to CVD causes, was significantly related to baseline walking disability in patients with knee or hip OA (Br. Med. J. 2011;342:d1165).
"One of the things that happens often with OA is that it’s seen as just pain and if we can give them plenty of relief, they’ll be OK, but it’s actually life-threatening because if we do not address their disability, they are at risk of dying," Dr. Valdes said in an interview. "I think this should be put on the front pages of the weekly medical journals, so that people are aware of the dangers of not treating osteoarthritis properly."
Comorbidity is a barrier to OA care, and 90% of those aged 65 years and older with OA have at least one other chronic condition, such as diabetes and heart disease, observed Dr. Hawker, professor of medicine at the University of Toronto and physician-in-chief of medicine, Women’s College Hospital in Toronto.
Her group reported in a separate presentation at the meeting that walking disability also raises the risk for diabetes complications in those with both OA and diabetes.
For the current population-based study, the investigators linked provincial health administrative databases to baseline surveys from a population cohort of 2,156 patients with symptomatic moderate to severe OA who were recruited in 1996-1998 through a screening survey in Ontario.
Their mean age was 71 years (all were 55 years or older), 72% were female, 34% obese, 20% had diabetes, and 40% had prebaseline CVD. Their average HAQ walking disability score was 2 on a 3-point scale, and they had a mean WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) summary score of 41. Overall, 44% used a walking aid. (A walking disability score of 2 corresponds with walking outdoors on flat ground with much difficulty, whereas a score of 3 means the person is unable to do it.)
After a median follow-up period of 13.2 years, 57% of patients had died, and 38% experienced the composite CVD outcome with a median of 9.2 years follow-up.
In multivariable analysis, there was a very clear dose-response, where increased walking disability was associated with increasing risk of all-cause death, Dr. Hawker said. The adjusted hazard ratio per unit increase in HAQ walking score was 1.30 (P less than .001), after controlling for confounders including age, sex, preexisting CVD, diabetes, hypertension, body mass index, and smoking status.
A HAQ walking score of 2 was associated with an adjusted hazard ratio of 1.69, which was actually greater than that associated with preexisting cardiovascular disease or diabetes, she said.
For the composite CVD outcome, there was also a significant association with HAQ walking score (adjusted HR, 1.17; P = .001).
Sensitivity analyses performed in 402 patients (18%) receiving postbaseline total joint arthroplasty (TJA ) showed that controlling for TJA did not change the effect of baseline disability but was protective for both all-cause death (HR, 0.62; P less than .001) and CVD events (HR, 0.66; P less than .001), Dr. Hawker said at the meeting sponsored by the Osteoarthritis Research Society International.
Although the data were not dichotomized, she noted that there was "beautiful discrimination" when they looked at the outcomes based on whether or not patients used a walking aid.
"Obviously, it’s nice to see a dose-response, but simply knowing that someone’s using a walking aid and getting them to the point where they’ve got improved walking ability, could go a long way," she said.
Though the study was not designed to address potential mechanisms, Dr. Hawker said she’s long argued that physical activity and mobility are a key player of downstream effects on fitness, blood pressure, glucose control, and ability to participate in self-management activities and physician visits. The potential role for pain, mood, and stress also can not be excluded.
One audience member asked whether walking disability may be a "cheap and dirty version" of the stress test.
Dr. Hawker responded that walking disability is a proxy for a lot of things and is definitely OA-related, adding, "Yes, I think it is a very cheap and dirty stress test. It’s a lovely thing that if we focused more explicitly on it in randomized trials, for instance as a primary outcome, or in rehabilitation strategies, it would have global benefit."
The authors reported no competing interests.
PARIS – Greater walking disability is an independent predictor of all-cause death and major cardiovascular events in patients with symptomatic hip or knee osteoarthritis, according to a population-based study that confirms previous research.
For the composite cardiovascular disease (CVD) outcome of hospitalization for angina, acute myocardial infarction, coronary revascularization, congestive heart failure, stroke, or transient ischemic attack, the risk associated with a Health Assessment Questionnaire (HAQ) walking disability score of 2 was the same as that of diabetes and pre-existing CVD.
Total joint replacement reduced those risks by about 40%, Dr. Gillian A. Hawker said at the World Congress on Osteoarthritis (OA).
"I think the key piece here is that these data at least suggest that walking disability is a cardiovascular risk factor similar to diabetes," she said. "When we’re talking about risk assessment for cardiovascular outcomes, which everyone does pretty routinely in medicine, walking disability, which is really osteoarthritis, is one of the risk factors that they should be assessing ... If we can just start asking, hopefully it will get us thinking about, ‘Wow, this person has OA,’ and we need to start assessing it."
Session comoderator Ana M. Valdes, Ph.D., of the University of Nottingham (England) commented that the results are fascinating because this is not the first study to identify these associations. In 2011, British investigators reported that all-cause mortality, particularly due to CVD causes, was significantly related to baseline walking disability in patients with knee or hip OA (Br. Med. J. 2011;342:d1165).
"One of the things that happens often with OA is that it’s seen as just pain and if we can give them plenty of relief, they’ll be OK, but it’s actually life-threatening because if we do not address their disability, they are at risk of dying," Dr. Valdes said in an interview. "I think this should be put on the front pages of the weekly medical journals, so that people are aware of the dangers of not treating osteoarthritis properly."
Comorbidity is a barrier to OA care, and 90% of those aged 65 years and older with OA have at least one other chronic condition, such as diabetes and heart disease, observed Dr. Hawker, professor of medicine at the University of Toronto and physician-in-chief of medicine, Women’s College Hospital in Toronto.
Her group reported in a separate presentation at the meeting that walking disability also raises the risk for diabetes complications in those with both OA and diabetes.
For the current population-based study, the investigators linked provincial health administrative databases to baseline surveys from a population cohort of 2,156 patients with symptomatic moderate to severe OA who were recruited in 1996-1998 through a screening survey in Ontario.
Their mean age was 71 years (all were 55 years or older), 72% were female, 34% obese, 20% had diabetes, and 40% had prebaseline CVD. Their average HAQ walking disability score was 2 on a 3-point scale, and they had a mean WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) summary score of 41. Overall, 44% used a walking aid. (A walking disability score of 2 corresponds with walking outdoors on flat ground with much difficulty, whereas a score of 3 means the person is unable to do it.)
After a median follow-up period of 13.2 years, 57% of patients had died, and 38% experienced the composite CVD outcome with a median of 9.2 years follow-up.
In multivariable analysis, there was a very clear dose-response, where increased walking disability was associated with increasing risk of all-cause death, Dr. Hawker said. The adjusted hazard ratio per unit increase in HAQ walking score was 1.30 (P less than .001), after controlling for confounders including age, sex, preexisting CVD, diabetes, hypertension, body mass index, and smoking status.
A HAQ walking score of 2 was associated with an adjusted hazard ratio of 1.69, which was actually greater than that associated with preexisting cardiovascular disease or diabetes, she said.
For the composite CVD outcome, there was also a significant association with HAQ walking score (adjusted HR, 1.17; P = .001).
Sensitivity analyses performed in 402 patients (18%) receiving postbaseline total joint arthroplasty (TJA ) showed that controlling for TJA did not change the effect of baseline disability but was protective for both all-cause death (HR, 0.62; P less than .001) and CVD events (HR, 0.66; P less than .001), Dr. Hawker said at the meeting sponsored by the Osteoarthritis Research Society International.
Although the data were not dichotomized, she noted that there was "beautiful discrimination" when they looked at the outcomes based on whether or not patients used a walking aid.
"Obviously, it’s nice to see a dose-response, but simply knowing that someone’s using a walking aid and getting them to the point where they’ve got improved walking ability, could go a long way," she said.
Though the study was not designed to address potential mechanisms, Dr. Hawker said she’s long argued that physical activity and mobility are a key player of downstream effects on fitness, blood pressure, glucose control, and ability to participate in self-management activities and physician visits. The potential role for pain, mood, and stress also can not be excluded.
One audience member asked whether walking disability may be a "cheap and dirty version" of the stress test.
Dr. Hawker responded that walking disability is a proxy for a lot of things and is definitely OA-related, adding, "Yes, I think it is a very cheap and dirty stress test. It’s a lovely thing that if we focused more explicitly on it in randomized trials, for instance as a primary outcome, or in rehabilitation strategies, it would have global benefit."
The authors reported no competing interests.
AT OARSI 2014
Key clinical point: A study confirming previous research suggests that a high level of walking disability in OA patients should be considered a strong risk factor for CVD.
Major finding: The adjusted hazard ratio per unit increase in HAQ walking score was 1.30 (P less than .001) for all-cause mortality and 1.17 (P = .001) for composite CVD events.
Data source: A population-based, cohort study in 2,156 hip and knee OA patients.
Disclosures: The authors reported no competing interests.
Vast majority of ED visits for acute heart failure become admissions
Nearly six of every seven patients presenting to U.S. emergency departments with acute heart failure are admitted. This means acute heart failure is "a major challenge" to emergency departments nationwide and consumes a sizeable portion of their resources.
"Strategies to reduce this clinical and economic burden are needed," said Dr. Alan B. Storrow of the department of emergency medicine, Vanderbilt University, Nashville, and his associates.
The investigators performed a retrospective cohort study to quantify the burden of acute heart failure on emergency medical care because "it is important ... to focus individual and health system strategies to address [these] challenges before they become overwhelming." To do so, they analyzed information from the Nationwide Emergency Department Sample, "the largest all-payer ED [emergency department] database in the United States," which contains 25-30 million records of ED visits for more than 950 hospitals.
For this study, the researchers assessed an average of 958,167 annual ED visits for acute heart failure over a 5-year period. They excluded patients with cardiogenic shock, unspecified shock, intubation, noninvasive ventilation, or acute myocardial infarction because such patients wouldn’t have been eligible for discharge from the ED, which was an important outcome for this analysis.
Overall, 83.7% of acute heart failure patients who presented to the ED were admitted for hospitalization. The median length of stay was 3.4 days. Median ED charges rose over time, from $1,075 to $1,558 per person (JACC Heart Failure 2014 April 30 [doi:10.1016/j.jchf.2014.01.006]).
Patients who presented to EDs at academic hospitals were 1.5 times more likely to be admitted than were those who presented to nonacademic hospitals.
Admission rates also varied with geographic location of the hospital. Patients who presented to EDs in the Northeast region of the country were the most likely to be admitted (90% admission rate), while those in the West were the least likely (79% admission rate).
Uninsured patients were admitted less often than insured patients, even though they were more likely to have significant comorbidities. However, uninsured patients who were admitted underwent more diagnostic and therapeutic procedures than did insured patients.
"These data strongly suggest the ED is increasingly being relied on to evaluate more complex patients, some of whom previously received care as outpatients, or were directly admitted from an outpatient setting. ... As a result, emergency physicians increasingly serve as the major decision makers for approximately one-half of all U.S. inpatient admissions," Dr. Storrow and his associates noted.
In addition, "Emergency physicians’ tolerance of ‘risk’ in relation to ED discharge decisions, especially for patients they do not have an ongoing relationship with, is likely lower than for other caregivers," they said.
Alternatives to admission must be considered, at least for a subset of patients who present to EDs with acute heart failure. For example, patients who are found not to have high-risk features could be managed for 24-48 hours in an observation unit or discharged home. "Exploring these alternative strategies is crucial because the prevalence of chronic heart failure, and ED presentations for acute heart failure, are expected to increase over the next decade," Dr. Storrow and his colleagues said.
They added that this study probably underestimated the burden of acute heart failure on EDs because some patients likely received primary diagnoses of pneumonia, chronic obstructive pulmonary disease, asthma, or pulmonary embolus, with acute heart failure listed only as a supporting diagnosis. Such patients wouldn’t have been included in the analysis.
This study was supported by the National Heart, Lung, and Blood Institute and the National Center for Advancing Translational Sciences. Dr. Storrow reported receiving grants from Abbott and Roche Diagnostics and is a consultant for Abbott, Astellas, and Novartis; his associates reported ties to numerous industry sources.
This study shows that the primary challenge is to identify which patients with acute heart failure who present to the emergency department can be rapidly and safely discharged or observed for a brief period, rather than admitted, said Dr. Peter S. Pang and Dr. Jeremiah D. Schuur.
A short observation period facilitates risk stratification, permits ongoing assessment of the patient’s response to initial therapy, and provides a chance to address immediate medical needs "as well as self-care, literacy, adherence, caregiver strain, and dietary education along with psychosocial and socioeconomic issues," they said.
"National efforts to decrease heart failure readmissions have received enormous support and focus. Why not an ED to home initiative or ED to observation unit to home strategy?"
Dr. Pang is in the department of emergency medicine and the Center for Cardiovascular Innovation at Northwestern University, Chicago. He reported ties to numerous pharmaceutical companies. Dr. Schuur is in the department of emergency medicine at Brigham and Women’s Hospital and Harvard Medical School, Boston. He reported ties to Blue Cross Blue Shield and United Healthcare. These remarks were taken from their accompanying editorial (JACC Heart Failure 2014 April 30 [doi:10.1016/j.jchf.2014.03.003).
This study shows that the primary challenge is to identify which patients with acute heart failure who present to the emergency department can be rapidly and safely discharged or observed for a brief period, rather than admitted, said Dr. Peter S. Pang and Dr. Jeremiah D. Schuur.
A short observation period facilitates risk stratification, permits ongoing assessment of the patient’s response to initial therapy, and provides a chance to address immediate medical needs "as well as self-care, literacy, adherence, caregiver strain, and dietary education along with psychosocial and socioeconomic issues," they said.
"National efforts to decrease heart failure readmissions have received enormous support and focus. Why not an ED to home initiative or ED to observation unit to home strategy?"
Dr. Pang is in the department of emergency medicine and the Center for Cardiovascular Innovation at Northwestern University, Chicago. He reported ties to numerous pharmaceutical companies. Dr. Schuur is in the department of emergency medicine at Brigham and Women’s Hospital and Harvard Medical School, Boston. He reported ties to Blue Cross Blue Shield and United Healthcare. These remarks were taken from their accompanying editorial (JACC Heart Failure 2014 April 30 [doi:10.1016/j.jchf.2014.03.003).
This study shows that the primary challenge is to identify which patients with acute heart failure who present to the emergency department can be rapidly and safely discharged or observed for a brief period, rather than admitted, said Dr. Peter S. Pang and Dr. Jeremiah D. Schuur.
A short observation period facilitates risk stratification, permits ongoing assessment of the patient’s response to initial therapy, and provides a chance to address immediate medical needs "as well as self-care, literacy, adherence, caregiver strain, and dietary education along with psychosocial and socioeconomic issues," they said.
"National efforts to decrease heart failure readmissions have received enormous support and focus. Why not an ED to home initiative or ED to observation unit to home strategy?"
Dr. Pang is in the department of emergency medicine and the Center for Cardiovascular Innovation at Northwestern University, Chicago. He reported ties to numerous pharmaceutical companies. Dr. Schuur is in the department of emergency medicine at Brigham and Women’s Hospital and Harvard Medical School, Boston. He reported ties to Blue Cross Blue Shield and United Healthcare. These remarks were taken from their accompanying editorial (JACC Heart Failure 2014 April 30 [doi:10.1016/j.jchf.2014.03.003).
Nearly six of every seven patients presenting to U.S. emergency departments with acute heart failure are admitted. This means acute heart failure is "a major challenge" to emergency departments nationwide and consumes a sizeable portion of their resources.
"Strategies to reduce this clinical and economic burden are needed," said Dr. Alan B. Storrow of the department of emergency medicine, Vanderbilt University, Nashville, and his associates.
The investigators performed a retrospective cohort study to quantify the burden of acute heart failure on emergency medical care because "it is important ... to focus individual and health system strategies to address [these] challenges before they become overwhelming." To do so, they analyzed information from the Nationwide Emergency Department Sample, "the largest all-payer ED [emergency department] database in the United States," which contains 25-30 million records of ED visits for more than 950 hospitals.
For this study, the researchers assessed an average of 958,167 annual ED visits for acute heart failure over a 5-year period. They excluded patients with cardiogenic shock, unspecified shock, intubation, noninvasive ventilation, or acute myocardial infarction because such patients wouldn’t have been eligible for discharge from the ED, which was an important outcome for this analysis.
Overall, 83.7% of acute heart failure patients who presented to the ED were admitted for hospitalization. The median length of stay was 3.4 days. Median ED charges rose over time, from $1,075 to $1,558 per person (JACC Heart Failure 2014 April 30 [doi:10.1016/j.jchf.2014.01.006]).
Patients who presented to EDs at academic hospitals were 1.5 times more likely to be admitted than were those who presented to nonacademic hospitals.
Admission rates also varied with geographic location of the hospital. Patients who presented to EDs in the Northeast region of the country were the most likely to be admitted (90% admission rate), while those in the West were the least likely (79% admission rate).
Uninsured patients were admitted less often than insured patients, even though they were more likely to have significant comorbidities. However, uninsured patients who were admitted underwent more diagnostic and therapeutic procedures than did insured patients.
"These data strongly suggest the ED is increasingly being relied on to evaluate more complex patients, some of whom previously received care as outpatients, or were directly admitted from an outpatient setting. ... As a result, emergency physicians increasingly serve as the major decision makers for approximately one-half of all U.S. inpatient admissions," Dr. Storrow and his associates noted.
In addition, "Emergency physicians’ tolerance of ‘risk’ in relation to ED discharge decisions, especially for patients they do not have an ongoing relationship with, is likely lower than for other caregivers," they said.
Alternatives to admission must be considered, at least for a subset of patients who present to EDs with acute heart failure. For example, patients who are found not to have high-risk features could be managed for 24-48 hours in an observation unit or discharged home. "Exploring these alternative strategies is crucial because the prevalence of chronic heart failure, and ED presentations for acute heart failure, are expected to increase over the next decade," Dr. Storrow and his colleagues said.
They added that this study probably underestimated the burden of acute heart failure on EDs because some patients likely received primary diagnoses of pneumonia, chronic obstructive pulmonary disease, asthma, or pulmonary embolus, with acute heart failure listed only as a supporting diagnosis. Such patients wouldn’t have been included in the analysis.
This study was supported by the National Heart, Lung, and Blood Institute and the National Center for Advancing Translational Sciences. Dr. Storrow reported receiving grants from Abbott and Roche Diagnostics and is a consultant for Abbott, Astellas, and Novartis; his associates reported ties to numerous industry sources.
Nearly six of every seven patients presenting to U.S. emergency departments with acute heart failure are admitted. This means acute heart failure is "a major challenge" to emergency departments nationwide and consumes a sizeable portion of their resources.
"Strategies to reduce this clinical and economic burden are needed," said Dr. Alan B. Storrow of the department of emergency medicine, Vanderbilt University, Nashville, and his associates.
The investigators performed a retrospective cohort study to quantify the burden of acute heart failure on emergency medical care because "it is important ... to focus individual and health system strategies to address [these] challenges before they become overwhelming." To do so, they analyzed information from the Nationwide Emergency Department Sample, "the largest all-payer ED [emergency department] database in the United States," which contains 25-30 million records of ED visits for more than 950 hospitals.
For this study, the researchers assessed an average of 958,167 annual ED visits for acute heart failure over a 5-year period. They excluded patients with cardiogenic shock, unspecified shock, intubation, noninvasive ventilation, or acute myocardial infarction because such patients wouldn’t have been eligible for discharge from the ED, which was an important outcome for this analysis.
Overall, 83.7% of acute heart failure patients who presented to the ED were admitted for hospitalization. The median length of stay was 3.4 days. Median ED charges rose over time, from $1,075 to $1,558 per person (JACC Heart Failure 2014 April 30 [doi:10.1016/j.jchf.2014.01.006]).
Patients who presented to EDs at academic hospitals were 1.5 times more likely to be admitted than were those who presented to nonacademic hospitals.
Admission rates also varied with geographic location of the hospital. Patients who presented to EDs in the Northeast region of the country were the most likely to be admitted (90% admission rate), while those in the West were the least likely (79% admission rate).
Uninsured patients were admitted less often than insured patients, even though they were more likely to have significant comorbidities. However, uninsured patients who were admitted underwent more diagnostic and therapeutic procedures than did insured patients.
"These data strongly suggest the ED is increasingly being relied on to evaluate more complex patients, some of whom previously received care as outpatients, or were directly admitted from an outpatient setting. ... As a result, emergency physicians increasingly serve as the major decision makers for approximately one-half of all U.S. inpatient admissions," Dr. Storrow and his associates noted.
In addition, "Emergency physicians’ tolerance of ‘risk’ in relation to ED discharge decisions, especially for patients they do not have an ongoing relationship with, is likely lower than for other caregivers," they said.
Alternatives to admission must be considered, at least for a subset of patients who present to EDs with acute heart failure. For example, patients who are found not to have high-risk features could be managed for 24-48 hours in an observation unit or discharged home. "Exploring these alternative strategies is crucial because the prevalence of chronic heart failure, and ED presentations for acute heart failure, are expected to increase over the next decade," Dr. Storrow and his colleagues said.
They added that this study probably underestimated the burden of acute heart failure on EDs because some patients likely received primary diagnoses of pneumonia, chronic obstructive pulmonary disease, asthma, or pulmonary embolus, with acute heart failure listed only as a supporting diagnosis. Such patients wouldn’t have been included in the analysis.
This study was supported by the National Heart, Lung, and Blood Institute and the National Center for Advancing Translational Sciences. Dr. Storrow reported receiving grants from Abbott and Roche Diagnostics and is a consultant for Abbott, Astellas, and Novartis; his associates reported ties to numerous industry sources.
FROM JACC: HEART FAILURE
Major finding: Overall, 83.7% of acute heart failure patients who presented to the ED were admitted for hospitalization.
Data source: A retrospective cohort study involving 958,167 annual ED visits for acute heart failure across the country.
Disclosures: This study was supported by the National Heart, Lung, and Blood Institute and the National Center for Advancing Translational Sciences. Dr. Storrow reported receiving grants from Abbott and Roche Diagnostics and is a consultant for Abbott, Astellas, and Novartis; his associates reported ties to numerous industry sources.
EXACT-HF: Allopurinol flops for heart failure
WASHINGTON – Allopurinol has no effect on heart failure, according to results from the multicenter, double-blind EXACT-HF study.
"In heart failure patients with reduced ejection fraction and hyperuricemia, xanthine oxidase inhibition with allopurinol safely lowers uric acid levels, but has no beneficial effect on clinical status, exercise capacity, quality of life, or left ventricular structure and function. Other adjunctive therapies for high-risk heart failure patients are clearly needed," Dr. Michael M. Givertz said in presenting the EXACT-HF results at the annual meeting of the American College of Cardiology.
Hopes were high going into EXACT-HF that xanthine oxidase inhibition would provide a much needed novel therapeutic approach to heart failure. A growing body of evidence suggests that oxidative stress plays a major role in ventricular remodeling and disease progression, and xanthine oxidase – a potential source of oxidative stress in heart failure – was a logical therapeutic target.
Moreover, in animal models of heart failure, as well as earlier short-term patient studies, allopurinol caused regression of left ventricular hypertrophy, improved endothelial function, and boosted myocardial efficiency while reducing myocardial oxygen demand, noted Dr. Givertz, medical director of heart transplant and circulatory assist at Brigham and Women’s Hospital, Boston.
EXACT-HF was a double-blind study in which 253 hyperuricemic heart failure patients with a median left ventricular ejection fraction (LVEF) of 24% and a median uric acid level of 11 mg/dL were placed on allopurinol or placebo and followed prospectively for 6 months. Allopurinol was started at 300 mg/day and, after 1 week, boosted to a target dose of 600 mg/day if tolerated.
The primary endpoint was a composite comprising death, hospitalization, or an emergency department or urgent care clinic visit for worsening heart failure; a medication change due to worsening heart failure; and patient global assessment. By this standard, roughly 45% of patients in both study arms were worse after 6 months, 16% were improved, and the rest were unchanged. Nor did the two groups differ significantly in terms of the various secondary and tertiary endpoints, including quality of life as assessed by the Kansas City Cardiomyopathy Score; the 6-minute walk test; levels of cystatin C, myeloperoxidase, and NT-proBNP (N-terminal of the prohormone brain natriuretic peptide); and left ventricular volume, mass, and ejection fraction.
Uric acid levels were reduced by about 45% in the allopurinol group. However, investigators never viewed hyperuricemia as a mediator of heart failure, but rather as a marker of more severe disease. And this was a population with fairly severe disease, as reflected in the 6% mortality rate at 6 months, along with a 30% rate of unscheduled outpatient visits and 38% rate of all-cause hospitalization, Dr. Givertz said.
Asked if he thought a longer treatment period might have shown therapeutic benefit, the cardiologist replied that there was one positive signal: The risk of heart failure hospitalization over the 6-month study was reduced by 33% in the allopurinol group, with the curves separating after 8-10 weeks, although the difference wasn’t statistically significant. But he was reluctant to make too much of this.
"It’s conceivable that if one treated for a year or longer with high doses of allopurinol, perhaps one might see a benefit. The argument against that is the consistency in the neutrality of the other endpoints at 6 months," according to Dr. Givertz.
Intriguingly, several recent studies suggest that colchicine – an even more venerable gout drug than allopurinol – may protect gout patients against cardiovascular events.
The EXACT-HF trial was sponsored by the National Heart, Lung, and Blood Institute and carried out by the NHLBI Heart Failure Clinical Research Network. Dr. Givertz reported serving as a consultant to Merck, Cardioxyl, and Janssen.
WASHINGTON – Allopurinol has no effect on heart failure, according to results from the multicenter, double-blind EXACT-HF study.
"In heart failure patients with reduced ejection fraction and hyperuricemia, xanthine oxidase inhibition with allopurinol safely lowers uric acid levels, but has no beneficial effect on clinical status, exercise capacity, quality of life, or left ventricular structure and function. Other adjunctive therapies for high-risk heart failure patients are clearly needed," Dr. Michael M. Givertz said in presenting the EXACT-HF results at the annual meeting of the American College of Cardiology.
Hopes were high going into EXACT-HF that xanthine oxidase inhibition would provide a much needed novel therapeutic approach to heart failure. A growing body of evidence suggests that oxidative stress plays a major role in ventricular remodeling and disease progression, and xanthine oxidase – a potential source of oxidative stress in heart failure – was a logical therapeutic target.
Moreover, in animal models of heart failure, as well as earlier short-term patient studies, allopurinol caused regression of left ventricular hypertrophy, improved endothelial function, and boosted myocardial efficiency while reducing myocardial oxygen demand, noted Dr. Givertz, medical director of heart transplant and circulatory assist at Brigham and Women’s Hospital, Boston.
EXACT-HF was a double-blind study in which 253 hyperuricemic heart failure patients with a median left ventricular ejection fraction (LVEF) of 24% and a median uric acid level of 11 mg/dL were placed on allopurinol or placebo and followed prospectively for 6 months. Allopurinol was started at 300 mg/day and, after 1 week, boosted to a target dose of 600 mg/day if tolerated.
The primary endpoint was a composite comprising death, hospitalization, or an emergency department or urgent care clinic visit for worsening heart failure; a medication change due to worsening heart failure; and patient global assessment. By this standard, roughly 45% of patients in both study arms were worse after 6 months, 16% were improved, and the rest were unchanged. Nor did the two groups differ significantly in terms of the various secondary and tertiary endpoints, including quality of life as assessed by the Kansas City Cardiomyopathy Score; the 6-minute walk test; levels of cystatin C, myeloperoxidase, and NT-proBNP (N-terminal of the prohormone brain natriuretic peptide); and left ventricular volume, mass, and ejection fraction.
Uric acid levels were reduced by about 45% in the allopurinol group. However, investigators never viewed hyperuricemia as a mediator of heart failure, but rather as a marker of more severe disease. And this was a population with fairly severe disease, as reflected in the 6% mortality rate at 6 months, along with a 30% rate of unscheduled outpatient visits and 38% rate of all-cause hospitalization, Dr. Givertz said.
Asked if he thought a longer treatment period might have shown therapeutic benefit, the cardiologist replied that there was one positive signal: The risk of heart failure hospitalization over the 6-month study was reduced by 33% in the allopurinol group, with the curves separating after 8-10 weeks, although the difference wasn’t statistically significant. But he was reluctant to make too much of this.
"It’s conceivable that if one treated for a year or longer with high doses of allopurinol, perhaps one might see a benefit. The argument against that is the consistency in the neutrality of the other endpoints at 6 months," according to Dr. Givertz.
Intriguingly, several recent studies suggest that colchicine – an even more venerable gout drug than allopurinol – may protect gout patients against cardiovascular events.
The EXACT-HF trial was sponsored by the National Heart, Lung, and Blood Institute and carried out by the NHLBI Heart Failure Clinical Research Network. Dr. Givertz reported serving as a consultant to Merck, Cardioxyl, and Janssen.
WASHINGTON – Allopurinol has no effect on heart failure, according to results from the multicenter, double-blind EXACT-HF study.
"In heart failure patients with reduced ejection fraction and hyperuricemia, xanthine oxidase inhibition with allopurinol safely lowers uric acid levels, but has no beneficial effect on clinical status, exercise capacity, quality of life, or left ventricular structure and function. Other adjunctive therapies for high-risk heart failure patients are clearly needed," Dr. Michael M. Givertz said in presenting the EXACT-HF results at the annual meeting of the American College of Cardiology.
Hopes were high going into EXACT-HF that xanthine oxidase inhibition would provide a much needed novel therapeutic approach to heart failure. A growing body of evidence suggests that oxidative stress plays a major role in ventricular remodeling and disease progression, and xanthine oxidase – a potential source of oxidative stress in heart failure – was a logical therapeutic target.
Moreover, in animal models of heart failure, as well as earlier short-term patient studies, allopurinol caused regression of left ventricular hypertrophy, improved endothelial function, and boosted myocardial efficiency while reducing myocardial oxygen demand, noted Dr. Givertz, medical director of heart transplant and circulatory assist at Brigham and Women’s Hospital, Boston.
EXACT-HF was a double-blind study in which 253 hyperuricemic heart failure patients with a median left ventricular ejection fraction (LVEF) of 24% and a median uric acid level of 11 mg/dL were placed on allopurinol or placebo and followed prospectively for 6 months. Allopurinol was started at 300 mg/day and, after 1 week, boosted to a target dose of 600 mg/day if tolerated.
The primary endpoint was a composite comprising death, hospitalization, or an emergency department or urgent care clinic visit for worsening heart failure; a medication change due to worsening heart failure; and patient global assessment. By this standard, roughly 45% of patients in both study arms were worse after 6 months, 16% were improved, and the rest were unchanged. Nor did the two groups differ significantly in terms of the various secondary and tertiary endpoints, including quality of life as assessed by the Kansas City Cardiomyopathy Score; the 6-minute walk test; levels of cystatin C, myeloperoxidase, and NT-proBNP (N-terminal of the prohormone brain natriuretic peptide); and left ventricular volume, mass, and ejection fraction.
Uric acid levels were reduced by about 45% in the allopurinol group. However, investigators never viewed hyperuricemia as a mediator of heart failure, but rather as a marker of more severe disease. And this was a population with fairly severe disease, as reflected in the 6% mortality rate at 6 months, along with a 30% rate of unscheduled outpatient visits and 38% rate of all-cause hospitalization, Dr. Givertz said.
Asked if he thought a longer treatment period might have shown therapeutic benefit, the cardiologist replied that there was one positive signal: The risk of heart failure hospitalization over the 6-month study was reduced by 33% in the allopurinol group, with the curves separating after 8-10 weeks, although the difference wasn’t statistically significant. But he was reluctant to make too much of this.
"It’s conceivable that if one treated for a year or longer with high doses of allopurinol, perhaps one might see a benefit. The argument against that is the consistency in the neutrality of the other endpoints at 6 months," according to Dr. Givertz.
Intriguingly, several recent studies suggest that colchicine – an even more venerable gout drug than allopurinol – may protect gout patients against cardiovascular events.
The EXACT-HF trial was sponsored by the National Heart, Lung, and Blood Institute and carried out by the NHLBI Heart Failure Clinical Research Network. Dr. Givertz reported serving as a consultant to Merck, Cardioxyl, and Janssen.
AT ACC 14
Major finding: Six months of therapy with allopurinol in patients with hyperuricemia and heart failure with reduced ejection fraction lowered their serum uric acid levels but had no effect on their heart failure.
Data source: EXACT-HF, a 6-month, double-blind, placebo-controlled trial conducted in 253 patients.
Disclosures: The EXACT-HF trial was sponsored by the National Heart, Lung, and Blood Institute and carried out by the NHLBI Heart Failure Clinical Research Network. Dr. Givertz reported serving as a consultant to Merck, Cardioxyl, and Janssen.
Life partner provides better heart failure outcomes
WASHINGTON – Marital status plays an underappreciated role in heart failure prognosis.
Indeed, having a life partner was independently associated with a 12% reduction in the risk of all-cause mortality or hospitalization during a median follow-up of 2.5 years in the randomized HF-ACTION trial, Dr. Robert J. Mentz reported at the annual meeting of the American College of Cardiology.
HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes in Exercise Training) was an 82-center, randomized trial examining the effects of exercise training in 2,331 heart failure patients with a left ventricular ejection fraction of 35% or less. The primary outcome has been reported previously (JAMA 2009;301:1439-50). In this new secondary analysis, Dr. Mentz and coinvestigators scrutinized the independent impacts of marital status, education level, and economic status on outcomes.
Of HF-ACTION participants, 61% had a current life partner at baseline, 60% had more than a high school education, and 59% had an annual income of at least $25,000. In a multivariate analysis controlling for demographics, comorbid conditions, heart failure etiology, and other potential confounders, life partner status was independently associated with a 12% lower composite event rate for all-cause mortality/hospitalization; education level and income didn’t have significant prognostic value, according to Dr. Mentz, a cardiologist at Duke University, Durham, N.C.
As this was a secondary analysis, the findings should be considered hypothesis generating. "Future prospective studies of social support interventions may be warranted to improve outcomes in this patient population," he observed.
Modern management of heart failure is complex, and fatigue is a prominent symptom. Possible mechanisms that might explain the observed benefit of life partnership in terms of patient outcomes include having someone at home to make sure the patient is taking medications appropriately. The spouse or life partner can also function as a second set of ears during clinic visits.
"When you’re in the physician’s office and information and instructions are coming at you like water out of a fire hose, your partner is there to write things down and help you remember points," Dr. Mentz noted.
The HF-ACTION trial was sponsored by the National Heart, Lung, and Blood Institute. Dr. Mentz reported having no relevant financial interests.
WASHINGTON – Marital status plays an underappreciated role in heart failure prognosis.
Indeed, having a life partner was independently associated with a 12% reduction in the risk of all-cause mortality or hospitalization during a median follow-up of 2.5 years in the randomized HF-ACTION trial, Dr. Robert J. Mentz reported at the annual meeting of the American College of Cardiology.
HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes in Exercise Training) was an 82-center, randomized trial examining the effects of exercise training in 2,331 heart failure patients with a left ventricular ejection fraction of 35% or less. The primary outcome has been reported previously (JAMA 2009;301:1439-50). In this new secondary analysis, Dr. Mentz and coinvestigators scrutinized the independent impacts of marital status, education level, and economic status on outcomes.
Of HF-ACTION participants, 61% had a current life partner at baseline, 60% had more than a high school education, and 59% had an annual income of at least $25,000. In a multivariate analysis controlling for demographics, comorbid conditions, heart failure etiology, and other potential confounders, life partner status was independently associated with a 12% lower composite event rate for all-cause mortality/hospitalization; education level and income didn’t have significant prognostic value, according to Dr. Mentz, a cardiologist at Duke University, Durham, N.C.
As this was a secondary analysis, the findings should be considered hypothesis generating. "Future prospective studies of social support interventions may be warranted to improve outcomes in this patient population," he observed.
Modern management of heart failure is complex, and fatigue is a prominent symptom. Possible mechanisms that might explain the observed benefit of life partnership in terms of patient outcomes include having someone at home to make sure the patient is taking medications appropriately. The spouse or life partner can also function as a second set of ears during clinic visits.
"When you’re in the physician’s office and information and instructions are coming at you like water out of a fire hose, your partner is there to write things down and help you remember points," Dr. Mentz noted.
The HF-ACTION trial was sponsored by the National Heart, Lung, and Blood Institute. Dr. Mentz reported having no relevant financial interests.
WASHINGTON – Marital status plays an underappreciated role in heart failure prognosis.
Indeed, having a life partner was independently associated with a 12% reduction in the risk of all-cause mortality or hospitalization during a median follow-up of 2.5 years in the randomized HF-ACTION trial, Dr. Robert J. Mentz reported at the annual meeting of the American College of Cardiology.
HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes in Exercise Training) was an 82-center, randomized trial examining the effects of exercise training in 2,331 heart failure patients with a left ventricular ejection fraction of 35% or less. The primary outcome has been reported previously (JAMA 2009;301:1439-50). In this new secondary analysis, Dr. Mentz and coinvestigators scrutinized the independent impacts of marital status, education level, and economic status on outcomes.
Of HF-ACTION participants, 61% had a current life partner at baseline, 60% had more than a high school education, and 59% had an annual income of at least $25,000. In a multivariate analysis controlling for demographics, comorbid conditions, heart failure etiology, and other potential confounders, life partner status was independently associated with a 12% lower composite event rate for all-cause mortality/hospitalization; education level and income didn’t have significant prognostic value, according to Dr. Mentz, a cardiologist at Duke University, Durham, N.C.
As this was a secondary analysis, the findings should be considered hypothesis generating. "Future prospective studies of social support interventions may be warranted to improve outcomes in this patient population," he observed.
Modern management of heart failure is complex, and fatigue is a prominent symptom. Possible mechanisms that might explain the observed benefit of life partnership in terms of patient outcomes include having someone at home to make sure the patient is taking medications appropriately. The spouse or life partner can also function as a second set of ears during clinic visits.
"When you’re in the physician’s office and information and instructions are coming at you like water out of a fire hose, your partner is there to write things down and help you remember points," Dr. Mentz noted.
The HF-ACTION trial was sponsored by the National Heart, Lung, and Blood Institute. Dr. Mentz reported having no relevant financial interests.
AT ACC 14
Major finding: Having a current life partner was independently associated with a 12% reduction in the risk of all-cause mortality or hospitalization among patients with heart failure.
Data source: This was a secondary analysis of data from a prospective 82-center study involving 2,331 patients with heart failure and a left ventricular ejection fraction of 35% or less who were followed for a median of 2.5 years.
Disclosures: The HF-ACTION trial was sponsored by the NHLBI. The presenter reported having no relevant financial interests.
Intervention manages cardiac patients with depression, anxiety
A low-intensity intervention aimed at managing cardiac patients who have concomitant depression or anxiety improved mental-health–related quality of life when compared with usual care, according to a report published online April 14 in JAMA Internal Medicine.
The MOSAIC (Management of Sadness and Anxiety in Cardiology) clinical trial involved 183 patients hospitalized at a single urban academic medical center for acute coronary syndrome, heart failure, or arrhythmia during a 2-year period and who were found to have coexisting depression, generalized anxiety disorder, and/or panic disorder. The mean age of the participants was 60.5 years, 90% were white, 61% were employed, 53% were women (JAMA Intern. Med. 2014 April 14 [doi:10.1001/jamainternmend.2014.739]).
They were randomly assigned to receive either usual care or a telephone-based intervention in which a part-time social work care manager coordinated care among psychiatrists, inpatient medical providers, and outpatient medical providers; provided cognitive-behavioral therapy specific to the patient’s condition; and monitored patient symptoms for the 6-month duration of the intervention, said Dr. Jeff C. Huffman, director of cardiac psychiatry research program at Massachusetts General Hospital, and who is in the department of psychiatry at Harvard Medical School, Boston, and his associates.
Patients in the intervention group showed a significantly greater improvement than did those who received usual care in the primary outcome measure: mental-health-related quality of life (QOL), as measured by the Medical Outcomes Study Short Form-12 Mental Component Score. They also were remarkably more likely to receive treatment deemed "adequate" for their psychiatric disorders (75% vs 7%), and to show significantly greater improvement in Patient Health Questionnaire-9 scores; in overall function, as measured on the Duke Activity Status Index; and in health care–related QOL, as measured by EuroQol 5-Domain Instrument scores.
No significant differences were found between the two study groups in cardiac readmission rates at 6 months, but the mean time to readmission was significantly longer for the intervention group (92.4 days) than for the usual care group (62.5 days), Dr. Huffman and his associates said.
The investigators noted that their study involved typical patients seen for cardiac care – including many with serious medical issues and some who declined psychiatric treatment – and so should reflect results that would be found in real-world settings. In addition, using a social worker instead of a nurse as care manager and using telephone rather than in-person contacts substantially saved on costs.
However, Dr. Huffman and his colleagues cited several limitations. For example, the study was conducted in an academic medical center with mostly white patients. Also, those who delivered the intervention had experience with that population and with collaborative care programs.
Still, they expressed optimism about the intervention’s potential. "This intervention seems to have substantial promise as an adjunct or alternative to standard [collaborative care] paradigms," they wrote. "We found that a single care manager was able to coordinate care of three psychiatric conditions in patients with a wide range of cardiac diagnoses living within and outside the metropolitan area of the hospital."
This work was supported in part by the American Heart Association. No relevant financial conflicts of interest were reported.
A low-intensity intervention aimed at managing cardiac patients who have concomitant depression or anxiety improved mental-health–related quality of life when compared with usual care, according to a report published online April 14 in JAMA Internal Medicine.
The MOSAIC (Management of Sadness and Anxiety in Cardiology) clinical trial involved 183 patients hospitalized at a single urban academic medical center for acute coronary syndrome, heart failure, or arrhythmia during a 2-year period and who were found to have coexisting depression, generalized anxiety disorder, and/or panic disorder. The mean age of the participants was 60.5 years, 90% were white, 61% were employed, 53% were women (JAMA Intern. Med. 2014 April 14 [doi:10.1001/jamainternmend.2014.739]).
They were randomly assigned to receive either usual care or a telephone-based intervention in which a part-time social work care manager coordinated care among psychiatrists, inpatient medical providers, and outpatient medical providers; provided cognitive-behavioral therapy specific to the patient’s condition; and monitored patient symptoms for the 6-month duration of the intervention, said Dr. Jeff C. Huffman, director of cardiac psychiatry research program at Massachusetts General Hospital, and who is in the department of psychiatry at Harvard Medical School, Boston, and his associates.
Patients in the intervention group showed a significantly greater improvement than did those who received usual care in the primary outcome measure: mental-health-related quality of life (QOL), as measured by the Medical Outcomes Study Short Form-12 Mental Component Score. They also were remarkably more likely to receive treatment deemed "adequate" for their psychiatric disorders (75% vs 7%), and to show significantly greater improvement in Patient Health Questionnaire-9 scores; in overall function, as measured on the Duke Activity Status Index; and in health care–related QOL, as measured by EuroQol 5-Domain Instrument scores.
No significant differences were found between the two study groups in cardiac readmission rates at 6 months, but the mean time to readmission was significantly longer for the intervention group (92.4 days) than for the usual care group (62.5 days), Dr. Huffman and his associates said.
The investigators noted that their study involved typical patients seen for cardiac care – including many with serious medical issues and some who declined psychiatric treatment – and so should reflect results that would be found in real-world settings. In addition, using a social worker instead of a nurse as care manager and using telephone rather than in-person contacts substantially saved on costs.
However, Dr. Huffman and his colleagues cited several limitations. For example, the study was conducted in an academic medical center with mostly white patients. Also, those who delivered the intervention had experience with that population and with collaborative care programs.
Still, they expressed optimism about the intervention’s potential. "This intervention seems to have substantial promise as an adjunct or alternative to standard [collaborative care] paradigms," they wrote. "We found that a single care manager was able to coordinate care of three psychiatric conditions in patients with a wide range of cardiac diagnoses living within and outside the metropolitan area of the hospital."
This work was supported in part by the American Heart Association. No relevant financial conflicts of interest were reported.
A low-intensity intervention aimed at managing cardiac patients who have concomitant depression or anxiety improved mental-health–related quality of life when compared with usual care, according to a report published online April 14 in JAMA Internal Medicine.
The MOSAIC (Management of Sadness and Anxiety in Cardiology) clinical trial involved 183 patients hospitalized at a single urban academic medical center for acute coronary syndrome, heart failure, or arrhythmia during a 2-year period and who were found to have coexisting depression, generalized anxiety disorder, and/or panic disorder. The mean age of the participants was 60.5 years, 90% were white, 61% were employed, 53% were women (JAMA Intern. Med. 2014 April 14 [doi:10.1001/jamainternmend.2014.739]).
They were randomly assigned to receive either usual care or a telephone-based intervention in which a part-time social work care manager coordinated care among psychiatrists, inpatient medical providers, and outpatient medical providers; provided cognitive-behavioral therapy specific to the patient’s condition; and monitored patient symptoms for the 6-month duration of the intervention, said Dr. Jeff C. Huffman, director of cardiac psychiatry research program at Massachusetts General Hospital, and who is in the department of psychiatry at Harvard Medical School, Boston, and his associates.
Patients in the intervention group showed a significantly greater improvement than did those who received usual care in the primary outcome measure: mental-health-related quality of life (QOL), as measured by the Medical Outcomes Study Short Form-12 Mental Component Score. They also were remarkably more likely to receive treatment deemed "adequate" for their psychiatric disorders (75% vs 7%), and to show significantly greater improvement in Patient Health Questionnaire-9 scores; in overall function, as measured on the Duke Activity Status Index; and in health care–related QOL, as measured by EuroQol 5-Domain Instrument scores.
No significant differences were found between the two study groups in cardiac readmission rates at 6 months, but the mean time to readmission was significantly longer for the intervention group (92.4 days) than for the usual care group (62.5 days), Dr. Huffman and his associates said.
The investigators noted that their study involved typical patients seen for cardiac care – including many with serious medical issues and some who declined psychiatric treatment – and so should reflect results that would be found in real-world settings. In addition, using a social worker instead of a nurse as care manager and using telephone rather than in-person contacts substantially saved on costs.
However, Dr. Huffman and his colleagues cited several limitations. For example, the study was conducted in an academic medical center with mostly white patients. Also, those who delivered the intervention had experience with that population and with collaborative care programs.
Still, they expressed optimism about the intervention’s potential. "This intervention seems to have substantial promise as an adjunct or alternative to standard [collaborative care] paradigms," they wrote. "We found that a single care manager was able to coordinate care of three psychiatric conditions in patients with a wide range of cardiac diagnoses living within and outside the metropolitan area of the hospital."
This work was supported in part by the American Heart Association. No relevant financial conflicts of interest were reported.
FROM JAMA INTERNAL MEDICINE
Major finding: Patients in the intervention group showed a significantly greater improvement than did those who received usual care in the primary outcome measure, mental-health–related QOL, as well as being remarkably more likely to receive treatment deemed "adequate" for their psychiatric disorder (75% vs. 7%) and showing significantly greater improvement in overall function and health-related QOL.
Data source: A randomized clinical trial comparing psychiatric outcomes after 6 months of usual care vs. a collaborative care intervention, involving 183 cardiac patients who had concomitant depression or anxiety.
Disclosures: This work was supported in part by the American Heart Association. No relevant financial conflicts of interest were reported.
FDA expands uses for cardiac resynchronization devices
The approval of cardiac resynchronization pacemakers and defibrillators manufactured by Medtronic has been expanded to include patients with atrioventricular block and less severe heart failure, the Food and Drug Administration announced on April 10.
The approval applies to two cardiac resynchronization pacemakers (CRT-Ps) and eight cardiac resynchronization defibrillators (CRT-Ds), and was based on the results of the BLOCK-HF study, according to the FDA statement.
The use of these devices "can delay the occurrence of heart failure–related urgent care visits for people who meet these new criteria," Christy Foreman, director of the office of device evaluation in the FDA’s Center for Devices and Radiological Health, said in the statement.
Previously, Medtronic CRT devices were approved for patients with moderate to severe heart failure (New York Heart Association class III and IV), and in April 2012, the FDA approved an expanded indication for Medtronic’s CRT-Ds to treat certain mildly symptomatic heart failure patients – before the addition of patients with atrioventricular block. The expanded approval includes patients with AV block and left ventricular systolic dysfunction, and allows patients with NYHA class I, II, and III with AV block and an ejection fraction of 50% or less to receive biventricular pacing with these devices, according to the Medtronic press release announcing the approval.
In the BLOCK-HF trial of 918 patients with an indication for pacing with AV block, NYHA class I, II, or III heart failure, and a left ventricular ejection fraction of 50% or less, patients were randomized to treatment with right ventricular or biventricular pacing. Those who required defibrillation therapy received an implantable cardioverter-defibrillator, and the others received a cardiac resynchronization pacemaker. Over an average of about 3 years, those in the biventricular pacing group showed a highly significant 26% reduction in risk of a composite of all-cause mortality, an urgent care visit for heart failure requiring intravenous therapy, or a 15% or greater increase in the left ventricular end-systolic volume index (the primary endpoint), compared with patients who had right ventricular pacing (N. Engl. J. Med. 2013;368:1585-93).
The 10 devices are the Consulta CRT-P, Consulta CRT-D, Syncra CRT-P, Maximo II CRT-D, Concerto II CRT-D, Viva XT CRT-D, Viva S CRT-D, Protecta CRT-D, Protecta XT CRT-D, and Brava CRT-D.
The approval of cardiac resynchronization pacemakers and defibrillators manufactured by Medtronic has been expanded to include patients with atrioventricular block and less severe heart failure, the Food and Drug Administration announced on April 10.
The approval applies to two cardiac resynchronization pacemakers (CRT-Ps) and eight cardiac resynchronization defibrillators (CRT-Ds), and was based on the results of the BLOCK-HF study, according to the FDA statement.
The use of these devices "can delay the occurrence of heart failure–related urgent care visits for people who meet these new criteria," Christy Foreman, director of the office of device evaluation in the FDA’s Center for Devices and Radiological Health, said in the statement.
Previously, Medtronic CRT devices were approved for patients with moderate to severe heart failure (New York Heart Association class III and IV), and in April 2012, the FDA approved an expanded indication for Medtronic’s CRT-Ds to treat certain mildly symptomatic heart failure patients – before the addition of patients with atrioventricular block. The expanded approval includes patients with AV block and left ventricular systolic dysfunction, and allows patients with NYHA class I, II, and III with AV block and an ejection fraction of 50% or less to receive biventricular pacing with these devices, according to the Medtronic press release announcing the approval.
In the BLOCK-HF trial of 918 patients with an indication for pacing with AV block, NYHA class I, II, or III heart failure, and a left ventricular ejection fraction of 50% or less, patients were randomized to treatment with right ventricular or biventricular pacing. Those who required defibrillation therapy received an implantable cardioverter-defibrillator, and the others received a cardiac resynchronization pacemaker. Over an average of about 3 years, those in the biventricular pacing group showed a highly significant 26% reduction in risk of a composite of all-cause mortality, an urgent care visit for heart failure requiring intravenous therapy, or a 15% or greater increase in the left ventricular end-systolic volume index (the primary endpoint), compared with patients who had right ventricular pacing (N. Engl. J. Med. 2013;368:1585-93).
The 10 devices are the Consulta CRT-P, Consulta CRT-D, Syncra CRT-P, Maximo II CRT-D, Concerto II CRT-D, Viva XT CRT-D, Viva S CRT-D, Protecta CRT-D, Protecta XT CRT-D, and Brava CRT-D.
The approval of cardiac resynchronization pacemakers and defibrillators manufactured by Medtronic has been expanded to include patients with atrioventricular block and less severe heart failure, the Food and Drug Administration announced on April 10.
The approval applies to two cardiac resynchronization pacemakers (CRT-Ps) and eight cardiac resynchronization defibrillators (CRT-Ds), and was based on the results of the BLOCK-HF study, according to the FDA statement.
The use of these devices "can delay the occurrence of heart failure–related urgent care visits for people who meet these new criteria," Christy Foreman, director of the office of device evaluation in the FDA’s Center for Devices and Radiological Health, said in the statement.
Previously, Medtronic CRT devices were approved for patients with moderate to severe heart failure (New York Heart Association class III and IV), and in April 2012, the FDA approved an expanded indication for Medtronic’s CRT-Ds to treat certain mildly symptomatic heart failure patients – before the addition of patients with atrioventricular block. The expanded approval includes patients with AV block and left ventricular systolic dysfunction, and allows patients with NYHA class I, II, and III with AV block and an ejection fraction of 50% or less to receive biventricular pacing with these devices, according to the Medtronic press release announcing the approval.
In the BLOCK-HF trial of 918 patients with an indication for pacing with AV block, NYHA class I, II, or III heart failure, and a left ventricular ejection fraction of 50% or less, patients were randomized to treatment with right ventricular or biventricular pacing. Those who required defibrillation therapy received an implantable cardioverter-defibrillator, and the others received a cardiac resynchronization pacemaker. Over an average of about 3 years, those in the biventricular pacing group showed a highly significant 26% reduction in risk of a composite of all-cause mortality, an urgent care visit for heart failure requiring intravenous therapy, or a 15% or greater increase in the left ventricular end-systolic volume index (the primary endpoint), compared with patients who had right ventricular pacing (N. Engl. J. Med. 2013;368:1585-93).
The 10 devices are the Consulta CRT-P, Consulta CRT-D, Syncra CRT-P, Maximo II CRT-D, Concerto II CRT-D, Viva XT CRT-D, Viva S CRT-D, Protecta CRT-D, Protecta XT CRT-D, and Brava CRT-D.
Diagnosing TOPCAT’s failure in HFpEF
Results of TOPCAT, one of the most talked about heart failure trials in recent years, have been published. There were no obvious surprises: Spironolactone is no more beneficial than placebo for patients who have heart failure with preserved ejection fraction.
Mineralocorticoid-receptor antagonists like spironolactone are known to reduce overall mortality and hospitalizations for HF in patients who have reduced ejection fraction, but their effect on patients with preserved ejection fraction "has not been rigorously tested" until now.
The TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist) study was a phase III, double-blind trial involving 3,445 patients treated at 233 sites in the United States, Canada, Brazil, Argentina, Russia, and Georgia. Patients were randomly assigned to receive either spironolactone (1,722 participants) or placebo (1,723 participants) and followed for a mean of 3.3 years, said Dr. Bertram Pitt of the University of Michigan, Ann Arbor, and his associates in a report published online April 9 in the New England Journal of Medicine.
The primary outcome measure – a composite of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for HF – occurred in 18.6% of patients given spironolactone and 20.4% of those given placebo. This corresponds to incidences of 5.9 events per 100 person-years with active treatment and 6.6 events per 100 person-years with placebo. Both differences were nonsignificant.
There also were no significant differences between the two study groups in time to death from any cause, time to hospitalization for any reason, cause of death, frequency of hospitalization for any reason, and rates of myocardial infarction or stroke, the investigators said (N. Engl. J. Med. 2014 April 9 [doi: 10.1056/NEJMoa1313731]).
In contrast, the 17% reduction in the rate of hospitalization for HFpEF in the spironolactone group relative to controls was significant (P = .04). Moreover, the spironolactone-treated patients had a collective 394 HFpEF hospitalizations, markedly fewer than the 475 in controls. This translated to hospitalization for HFpEF occurring at a rate of 3.8 per 100 person-years in patients randomized to spironolactone, compared with 4.6 per 100 person-years in placebo-treated controls.
The mystifyingly neutral results of this large international trial, presented in November at the annual meeting of the American Heart Association, coincided with a rapidly increasing incidence and awareness of heart failure with preserved ejection fraction, or HFpEF.
Speculation has focused on the differences in treatment response in two areas: geographical location and enrollment criteria.
Geographical differences in event rates have led some to conclude that patients in Eastern Europe just weren’t sick enough to be enrolled. Among patients in the placebo group, the primary endpoint of death or heart failure hospitalization during follow-up occurred at a rate of 12.6 events per 100 patient-years among the 881 patients treated in the four Western Hemisphere countries, and at a rate of 2.3 events per 100 patient-years among the 842 patients treated in Russia or Georgia, a greater than fivefold difference between the two subgroups.
"As a whole, the patients in Russia and Georgia had a lower event rate and were certainly less severely ill than the other patients, but they supposedly still had heart failure," Dr. Scott D. Solomon, professor of medicine at Harvard Medical School and director of noninvasive cardiology at Brigham and Women’s Hospital, Boston, said in an earlier interview. "Defining this disorder is difficult, and when a patient has signs and symptoms of heart failure and preserved ejection fraction, you may not be certain that heart failure is causing the symptoms. That’s why many people think that we should use another criterion" to define HFpEF in trials, such as elevated serum level of some form of natriuretic peptide, said Dr. Solomon, a TOPCAT coinvestigator.
By design, patients could enter TOPCAT either because of a recent heart failure hospitalization, which is how 72% of patients got in, or by having a threshold level of natriuretic peptide, the way the remaining 28% entered the study. Within the subgroup enrolled by natriuretic peptide level, spironolactone treatment had a statistically significant effect in reducing the primary endpoint, while in the other 72% the drug produced no discernable benefit over placebo.
The neutral results of TOPCAT represent more than another failed treatment trial; they underscore the heterogeneity of patients diagnosed with HFpEF.
TOPCAT was supported by the National Heart, Lung, and Blood Institute. Dr. Pitt reported ties to AuraSense Therapeutics, Relypsa, and other companies. His associates reported ties to numerous industry sources. Dr. Solomon has financial ties to Novartis and more than 10 other drug and device companies.
An exploratory post hoc analysis of the data showed that spironolactone was somewhat beneficial at preventing HF hospitalizations among patients in the Americas but not those in Russia and Georgia, said Dr. John J.V. McMurray and Dr. Christopher O’Connor.
This may reflect a true, though slight, treatment effect, or it may simply reflect differences between these geographically distinct regions. Perhaps the clinical characteristics of the patient populations in each area are quite different, or perhaps there are differences in standards of care or in "methodologic expertise in the conduct of clinical trials." Or, as the authors noted, there may be regional heterogeneity in coexisting conditions, in the indications for hospitalization, or in the ability to make the somewhat challenging diagnosis of HF with preserved ejection fraction.
John J. V. McMurray, M.D., is at the British Heart Foundation Cardiovascular Research Centre at the University of Glasgow (Scotland). Christopher O’Connor, M.D., is at Duke University Medical Center, Durham, N.C. Dr. McMurray reported ties to Novartis and Pfizer, and Dr. O’Connor reported ties to Roche, GE Healthcare, and other companies. These remarks were taken from their editorial accompanying Dr. Pitt’s report (N. Engl. J. Med. 2014 April 9 [doi: 10.1056/NEJMe1401231]).
An exploratory post hoc analysis of the data showed that spironolactone was somewhat beneficial at preventing HF hospitalizations among patients in the Americas but not those in Russia and Georgia, said Dr. John J.V. McMurray and Dr. Christopher O’Connor.
This may reflect a true, though slight, treatment effect, or it may simply reflect differences between these geographically distinct regions. Perhaps the clinical characteristics of the patient populations in each area are quite different, or perhaps there are differences in standards of care or in "methodologic expertise in the conduct of clinical trials." Or, as the authors noted, there may be regional heterogeneity in coexisting conditions, in the indications for hospitalization, or in the ability to make the somewhat challenging diagnosis of HF with preserved ejection fraction.
John J. V. McMurray, M.D., is at the British Heart Foundation Cardiovascular Research Centre at the University of Glasgow (Scotland). Christopher O’Connor, M.D., is at Duke University Medical Center, Durham, N.C. Dr. McMurray reported ties to Novartis and Pfizer, and Dr. O’Connor reported ties to Roche, GE Healthcare, and other companies. These remarks were taken from their editorial accompanying Dr. Pitt’s report (N. Engl. J. Med. 2014 April 9 [doi: 10.1056/NEJMe1401231]).
An exploratory post hoc analysis of the data showed that spironolactone was somewhat beneficial at preventing HF hospitalizations among patients in the Americas but not those in Russia and Georgia, said Dr. John J.V. McMurray and Dr. Christopher O’Connor.
This may reflect a true, though slight, treatment effect, or it may simply reflect differences between these geographically distinct regions. Perhaps the clinical characteristics of the patient populations in each area are quite different, or perhaps there are differences in standards of care or in "methodologic expertise in the conduct of clinical trials." Or, as the authors noted, there may be regional heterogeneity in coexisting conditions, in the indications for hospitalization, or in the ability to make the somewhat challenging diagnosis of HF with preserved ejection fraction.
John J. V. McMurray, M.D., is at the British Heart Foundation Cardiovascular Research Centre at the University of Glasgow (Scotland). Christopher O’Connor, M.D., is at Duke University Medical Center, Durham, N.C. Dr. McMurray reported ties to Novartis and Pfizer, and Dr. O’Connor reported ties to Roche, GE Healthcare, and other companies. These remarks were taken from their editorial accompanying Dr. Pitt’s report (N. Engl. J. Med. 2014 April 9 [doi: 10.1056/NEJMe1401231]).
Results of TOPCAT, one of the most talked about heart failure trials in recent years, have been published. There were no obvious surprises: Spironolactone is no more beneficial than placebo for patients who have heart failure with preserved ejection fraction.
Mineralocorticoid-receptor antagonists like spironolactone are known to reduce overall mortality and hospitalizations for HF in patients who have reduced ejection fraction, but their effect on patients with preserved ejection fraction "has not been rigorously tested" until now.
The TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist) study was a phase III, double-blind trial involving 3,445 patients treated at 233 sites in the United States, Canada, Brazil, Argentina, Russia, and Georgia. Patients were randomly assigned to receive either spironolactone (1,722 participants) or placebo (1,723 participants) and followed for a mean of 3.3 years, said Dr. Bertram Pitt of the University of Michigan, Ann Arbor, and his associates in a report published online April 9 in the New England Journal of Medicine.
The primary outcome measure – a composite of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for HF – occurred in 18.6% of patients given spironolactone and 20.4% of those given placebo. This corresponds to incidences of 5.9 events per 100 person-years with active treatment and 6.6 events per 100 person-years with placebo. Both differences were nonsignificant.
There also were no significant differences between the two study groups in time to death from any cause, time to hospitalization for any reason, cause of death, frequency of hospitalization for any reason, and rates of myocardial infarction or stroke, the investigators said (N. Engl. J. Med. 2014 April 9 [doi: 10.1056/NEJMoa1313731]).
In contrast, the 17% reduction in the rate of hospitalization for HFpEF in the spironolactone group relative to controls was significant (P = .04). Moreover, the spironolactone-treated patients had a collective 394 HFpEF hospitalizations, markedly fewer than the 475 in controls. This translated to hospitalization for HFpEF occurring at a rate of 3.8 per 100 person-years in patients randomized to spironolactone, compared with 4.6 per 100 person-years in placebo-treated controls.
The mystifyingly neutral results of this large international trial, presented in November at the annual meeting of the American Heart Association, coincided with a rapidly increasing incidence and awareness of heart failure with preserved ejection fraction, or HFpEF.
Speculation has focused on the differences in treatment response in two areas: geographical location and enrollment criteria.
Geographical differences in event rates have led some to conclude that patients in Eastern Europe just weren’t sick enough to be enrolled. Among patients in the placebo group, the primary endpoint of death or heart failure hospitalization during follow-up occurred at a rate of 12.6 events per 100 patient-years among the 881 patients treated in the four Western Hemisphere countries, and at a rate of 2.3 events per 100 patient-years among the 842 patients treated in Russia or Georgia, a greater than fivefold difference between the two subgroups.
"As a whole, the patients in Russia and Georgia had a lower event rate and were certainly less severely ill than the other patients, but they supposedly still had heart failure," Dr. Scott D. Solomon, professor of medicine at Harvard Medical School and director of noninvasive cardiology at Brigham and Women’s Hospital, Boston, said in an earlier interview. "Defining this disorder is difficult, and when a patient has signs and symptoms of heart failure and preserved ejection fraction, you may not be certain that heart failure is causing the symptoms. That’s why many people think that we should use another criterion" to define HFpEF in trials, such as elevated serum level of some form of natriuretic peptide, said Dr. Solomon, a TOPCAT coinvestigator.
By design, patients could enter TOPCAT either because of a recent heart failure hospitalization, which is how 72% of patients got in, or by having a threshold level of natriuretic peptide, the way the remaining 28% entered the study. Within the subgroup enrolled by natriuretic peptide level, spironolactone treatment had a statistically significant effect in reducing the primary endpoint, while in the other 72% the drug produced no discernable benefit over placebo.
The neutral results of TOPCAT represent more than another failed treatment trial; they underscore the heterogeneity of patients diagnosed with HFpEF.
TOPCAT was supported by the National Heart, Lung, and Blood Institute. Dr. Pitt reported ties to AuraSense Therapeutics, Relypsa, and other companies. His associates reported ties to numerous industry sources. Dr. Solomon has financial ties to Novartis and more than 10 other drug and device companies.
Results of TOPCAT, one of the most talked about heart failure trials in recent years, have been published. There were no obvious surprises: Spironolactone is no more beneficial than placebo for patients who have heart failure with preserved ejection fraction.
Mineralocorticoid-receptor antagonists like spironolactone are known to reduce overall mortality and hospitalizations for HF in patients who have reduced ejection fraction, but their effect on patients with preserved ejection fraction "has not been rigorously tested" until now.
The TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist) study was a phase III, double-blind trial involving 3,445 patients treated at 233 sites in the United States, Canada, Brazil, Argentina, Russia, and Georgia. Patients were randomly assigned to receive either spironolactone (1,722 participants) or placebo (1,723 participants) and followed for a mean of 3.3 years, said Dr. Bertram Pitt of the University of Michigan, Ann Arbor, and his associates in a report published online April 9 in the New England Journal of Medicine.
The primary outcome measure – a composite of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for HF – occurred in 18.6% of patients given spironolactone and 20.4% of those given placebo. This corresponds to incidences of 5.9 events per 100 person-years with active treatment and 6.6 events per 100 person-years with placebo. Both differences were nonsignificant.
There also were no significant differences between the two study groups in time to death from any cause, time to hospitalization for any reason, cause of death, frequency of hospitalization for any reason, and rates of myocardial infarction or stroke, the investigators said (N. Engl. J. Med. 2014 April 9 [doi: 10.1056/NEJMoa1313731]).
In contrast, the 17% reduction in the rate of hospitalization for HFpEF in the spironolactone group relative to controls was significant (P = .04). Moreover, the spironolactone-treated patients had a collective 394 HFpEF hospitalizations, markedly fewer than the 475 in controls. This translated to hospitalization for HFpEF occurring at a rate of 3.8 per 100 person-years in patients randomized to spironolactone, compared with 4.6 per 100 person-years in placebo-treated controls.
The mystifyingly neutral results of this large international trial, presented in November at the annual meeting of the American Heart Association, coincided with a rapidly increasing incidence and awareness of heart failure with preserved ejection fraction, or HFpEF.
Speculation has focused on the differences in treatment response in two areas: geographical location and enrollment criteria.
Geographical differences in event rates have led some to conclude that patients in Eastern Europe just weren’t sick enough to be enrolled. Among patients in the placebo group, the primary endpoint of death or heart failure hospitalization during follow-up occurred at a rate of 12.6 events per 100 patient-years among the 881 patients treated in the four Western Hemisphere countries, and at a rate of 2.3 events per 100 patient-years among the 842 patients treated in Russia or Georgia, a greater than fivefold difference between the two subgroups.
"As a whole, the patients in Russia and Georgia had a lower event rate and were certainly less severely ill than the other patients, but they supposedly still had heart failure," Dr. Scott D. Solomon, professor of medicine at Harvard Medical School and director of noninvasive cardiology at Brigham and Women’s Hospital, Boston, said in an earlier interview. "Defining this disorder is difficult, and when a patient has signs and symptoms of heart failure and preserved ejection fraction, you may not be certain that heart failure is causing the symptoms. That’s why many people think that we should use another criterion" to define HFpEF in trials, such as elevated serum level of some form of natriuretic peptide, said Dr. Solomon, a TOPCAT coinvestigator.
By design, patients could enter TOPCAT either because of a recent heart failure hospitalization, which is how 72% of patients got in, or by having a threshold level of natriuretic peptide, the way the remaining 28% entered the study. Within the subgroup enrolled by natriuretic peptide level, spironolactone treatment had a statistically significant effect in reducing the primary endpoint, while in the other 72% the drug produced no discernable benefit over placebo.
The neutral results of TOPCAT represent more than another failed treatment trial; they underscore the heterogeneity of patients diagnosed with HFpEF.
TOPCAT was supported by the National Heart, Lung, and Blood Institute. Dr. Pitt reported ties to AuraSense Therapeutics, Relypsa, and other companies. His associates reported ties to numerous industry sources. Dr. Solomon has financial ties to Novartis and more than 10 other drug and device companies.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Major finding: The primary outcome measure – a composite of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for HF – occurred in 18.6% of patients given spironolactone and 20.4% of those given placebo, a nonsignificant difference.
Data source: TOPCAT, an international randomized, double-blind, phase III trial in 3,445 HFpEF patients treated with either spironolactone or placebo and followed for a mean of 3.3 years.
Disclosures: TOPCAT was supported by the National Heart, Lung, and Blood Institute. Dr. Pitt reported ties to AuraSense Therapeutics, Relypsa, and other companies. His associates reported ties to numerous industry sources. Dr. Solomon has financial ties to Novartis and more than 10 other drug and device companies.
How to spend 2 days as a cognitive cardiologist
WASHINGTON – Another annual meeting of the American College of Cardiology has drawn to a close, and aside from the seemingly endless rain (and brief snow flurries), a lot of interesting discourse took place.
In the heart failure discipline, we have to a large degree become incrementalists: Although there were no blockbusters, important data on renal denervation were released, and corridor discussions about serelaxin and ivabradine were animated. At a time of ICD-10 rollouts, electronic health record (EHR) struggles, board recertification challenges, accreditation, precertification, compliance mandates, and more, it was a delight to be a cognitive cardiologist again. For a few precious moments, we could own our profession again.
We saw no hospital administrators; we did not receive any missives about the (lack of) timeliness of closing encounters in EHRs; we engaged in real peer-to-peer interactions with real peers, unlike the shadow variant we deal with during an appeal of an insurance coverage decision.
And then it was over, ironically with the sun shining. It’s now back to work, but perhaps with renewed purpose. Let’s find ways to reestablish facts on the ground: Our patients and the decisions we make about our patients come first. Research and teaching do, too. Hospital administrators? Send them to a very long annual meeting. And hope that they forget to pack umbrellas.
Dr. Hauptman is professor of internal medicine and assistant dean of clinical-translational research at Saint Louis University and director of heart failure at Saint Louis University Hospital.
WASHINGTON – Another annual meeting of the American College of Cardiology has drawn to a close, and aside from the seemingly endless rain (and brief snow flurries), a lot of interesting discourse took place.
In the heart failure discipline, we have to a large degree become incrementalists: Although there were no blockbusters, important data on renal denervation were released, and corridor discussions about serelaxin and ivabradine were animated. At a time of ICD-10 rollouts, electronic health record (EHR) struggles, board recertification challenges, accreditation, precertification, compliance mandates, and more, it was a delight to be a cognitive cardiologist again. For a few precious moments, we could own our profession again.
We saw no hospital administrators; we did not receive any missives about the (lack of) timeliness of closing encounters in EHRs; we engaged in real peer-to-peer interactions with real peers, unlike the shadow variant we deal with during an appeal of an insurance coverage decision.
And then it was over, ironically with the sun shining. It’s now back to work, but perhaps with renewed purpose. Let’s find ways to reestablish facts on the ground: Our patients and the decisions we make about our patients come first. Research and teaching do, too. Hospital administrators? Send them to a very long annual meeting. And hope that they forget to pack umbrellas.
Dr. Hauptman is professor of internal medicine and assistant dean of clinical-translational research at Saint Louis University and director of heart failure at Saint Louis University Hospital.
WASHINGTON – Another annual meeting of the American College of Cardiology has drawn to a close, and aside from the seemingly endless rain (and brief snow flurries), a lot of interesting discourse took place.
In the heart failure discipline, we have to a large degree become incrementalists: Although there were no blockbusters, important data on renal denervation were released, and corridor discussions about serelaxin and ivabradine were animated. At a time of ICD-10 rollouts, electronic health record (EHR) struggles, board recertification challenges, accreditation, precertification, compliance mandates, and more, it was a delight to be a cognitive cardiologist again. For a few precious moments, we could own our profession again.
We saw no hospital administrators; we did not receive any missives about the (lack of) timeliness of closing encounters in EHRs; we engaged in real peer-to-peer interactions with real peers, unlike the shadow variant we deal with during an appeal of an insurance coverage decision.
And then it was over, ironically with the sun shining. It’s now back to work, but perhaps with renewed purpose. Let’s find ways to reestablish facts on the ground: Our patients and the decisions we make about our patients come first. Research and teaching do, too. Hospital administrators? Send them to a very long annual meeting. And hope that they forget to pack umbrellas.
Dr. Hauptman is professor of internal medicine and assistant dean of clinical-translational research at Saint Louis University and director of heart failure at Saint Louis University Hospital.
No improvements in left ventricular function with metformin after myocardial infarction
Treatment with metformin failed to show any positive effects on left ventricular function in diabetes-free patients who presented with ST-segment elevation MI, according to the results of a double-blind, placebo-controlled study.
The study in 380 patients undergoing primary percutaneous coronary intervention – 191 of whom were given metformin and 189 of whom were given placebo – found no significant effects of twice-daily metformin (500 mg) on left ventricular ejection fraction (LVEF) after 4 months of treatment, and there was no significant difference in the incidence of major cardiac events between the two groups, Dr. Chris P. H. Lexis said at the annual meeting of the American College of Cardiology.
Specifically, at 4 months, all patients were alive and none were lost to follow-up. LVEF was 53.1% in the metformin group, compared with 54.8% in the placebo group. NT-proBNP concentration was 167 ng/L in the metformin group and 167 ng/L in the placebo group. Major adverse cardiovascular events were observed in six patients (3.1%) in the metformin group and in two patients (1.1%) in the placebo group. Creatinine concentration (79 micromol/L vs. 79 micromol/L) and glycated hemoglobin (5.9% vs. 5.9%) were not significantly different between both groups. No cases of lactic acidosis were observed, according to the investigators.
Up to half of patients who experience an ST-segment elevation MI (STEMI) develop left ventricular dysfunction, which is the strongest predictor of adverse outcomes, such as heart failure.
Findings from previous animal studies had suggested that metformin may have favorable effects on ventricular function, possibly through enhanced phosphorylation of AMP-activated protein kinase causing changes in intracellular pathways and altering mitochondrial function, in turn resulting in improved systolic and diastolic function.
"Data from experimental studies have suggested that administration of metformin before and during ischemia reperfusion might affect these protective pathways and preserve left ventricular function, independent of glycometabolic state," according to Dr. Lexis of the University of Groningen, the Netherlands, and his associates, in a paper simultaneously published online in JAMA (2014 March 31 [doi:10.1001/jama.2014.3315]).
"Moreover, in observational studies of patients with acute myocardial infarction, concurrent treatment with metformin was associated with lower peak values of CK [creatine kinase], myocardial band of CK, and troponins and with improved survival after STEMI in patients with type 2 diabetes, compared with other antihyperglycemic strategies."
percutaneous coronary intervention, PCI, LVEF, ACC, American College of Cardiology, Dr. Chris P. H. Lexis
Treatment with metformin failed to show any positive effects on left ventricular function in diabetes-free patients who presented with ST-segment elevation MI, according to the results of a double-blind, placebo-controlled study.
The study in 380 patients undergoing primary percutaneous coronary intervention – 191 of whom were given metformin and 189 of whom were given placebo – found no significant effects of twice-daily metformin (500 mg) on left ventricular ejection fraction (LVEF) after 4 months of treatment, and there was no significant difference in the incidence of major cardiac events between the two groups, Dr. Chris P. H. Lexis said at the annual meeting of the American College of Cardiology.
Specifically, at 4 months, all patients were alive and none were lost to follow-up. LVEF was 53.1% in the metformin group, compared with 54.8% in the placebo group. NT-proBNP concentration was 167 ng/L in the metformin group and 167 ng/L in the placebo group. Major adverse cardiovascular events were observed in six patients (3.1%) in the metformin group and in two patients (1.1%) in the placebo group. Creatinine concentration (79 micromol/L vs. 79 micromol/L) and glycated hemoglobin (5.9% vs. 5.9%) were not significantly different between both groups. No cases of lactic acidosis were observed, according to the investigators.
Up to half of patients who experience an ST-segment elevation MI (STEMI) develop left ventricular dysfunction, which is the strongest predictor of adverse outcomes, such as heart failure.
Findings from previous animal studies had suggested that metformin may have favorable effects on ventricular function, possibly through enhanced phosphorylation of AMP-activated protein kinase causing changes in intracellular pathways and altering mitochondrial function, in turn resulting in improved systolic and diastolic function.
"Data from experimental studies have suggested that administration of metformin before and during ischemia reperfusion might affect these protective pathways and preserve left ventricular function, independent of glycometabolic state," according to Dr. Lexis of the University of Groningen, the Netherlands, and his associates, in a paper simultaneously published online in JAMA (2014 March 31 [doi:10.1001/jama.2014.3315]).
"Moreover, in observational studies of patients with acute myocardial infarction, concurrent treatment with metformin was associated with lower peak values of CK [creatine kinase], myocardial band of CK, and troponins and with improved survival after STEMI in patients with type 2 diabetes, compared with other antihyperglycemic strategies."
Treatment with metformin failed to show any positive effects on left ventricular function in diabetes-free patients who presented with ST-segment elevation MI, according to the results of a double-blind, placebo-controlled study.
The study in 380 patients undergoing primary percutaneous coronary intervention – 191 of whom were given metformin and 189 of whom were given placebo – found no significant effects of twice-daily metformin (500 mg) on left ventricular ejection fraction (LVEF) after 4 months of treatment, and there was no significant difference in the incidence of major cardiac events between the two groups, Dr. Chris P. H. Lexis said at the annual meeting of the American College of Cardiology.
Specifically, at 4 months, all patients were alive and none were lost to follow-up. LVEF was 53.1% in the metformin group, compared with 54.8% in the placebo group. NT-proBNP concentration was 167 ng/L in the metformin group and 167 ng/L in the placebo group. Major adverse cardiovascular events were observed in six patients (3.1%) in the metformin group and in two patients (1.1%) in the placebo group. Creatinine concentration (79 micromol/L vs. 79 micromol/L) and glycated hemoglobin (5.9% vs. 5.9%) were not significantly different between both groups. No cases of lactic acidosis were observed, according to the investigators.
Up to half of patients who experience an ST-segment elevation MI (STEMI) develop left ventricular dysfunction, which is the strongest predictor of adverse outcomes, such as heart failure.
Findings from previous animal studies had suggested that metformin may have favorable effects on ventricular function, possibly through enhanced phosphorylation of AMP-activated protein kinase causing changes in intracellular pathways and altering mitochondrial function, in turn resulting in improved systolic and diastolic function.
"Data from experimental studies have suggested that administration of metformin before and during ischemia reperfusion might affect these protective pathways and preserve left ventricular function, independent of glycometabolic state," according to Dr. Lexis of the University of Groningen, the Netherlands, and his associates, in a paper simultaneously published online in JAMA (2014 March 31 [doi:10.1001/jama.2014.3315]).
"Moreover, in observational studies of patients with acute myocardial infarction, concurrent treatment with metformin was associated with lower peak values of CK [creatine kinase], myocardial band of CK, and troponins and with improved survival after STEMI in patients with type 2 diabetes, compared with other antihyperglycemic strategies."
percutaneous coronary intervention, PCI, LVEF, ACC, American College of Cardiology, Dr. Chris P. H. Lexis
percutaneous coronary intervention, PCI, LVEF, ACC, American College of Cardiology, Dr. Chris P. H. Lexis
FROM ACC 14
Major finding: Treatment with metformin after STEMI had no significant impact on LVEF or on the incidence of major cardiac events in nondiabetic patients undergoing primary percutaneous coronary intervention.
Data source: A randomized, double-blind, placebo controlled trial in 380 patients undergoing primary percutaneous coronary intervention after STEMI.
Disclosures: The study was supported by a grant from ZonMw, the Netherlands Organization for Health Research and Development. Some authors reported research grants, consultancies, speakers fees, and travel fees from various pharmaceutical companies.
ARB, ACE inhibitor at discharge curb heart failure readmissions
WASHINGTON – Patients with acute heart failure who were discharged on an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker were significantly less likely to be readmitted to the hospital within 30 days of discharge than patients who were not prescribed these drugs, in a retrospective study of Medicare beneficiaries.
Using data from the Alabama Heart Failure Project, the study looked at hospital readmission rates in 1,348 patients with acute decompensated heart failure and an ejection fraction under 45%, discharged from 106 hospitals in the United States. Their mean age was 75 years, they had similar renal function, they were on various baseline cardiac medications, and they had no contraindications for angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) treatment. Of these patients, 734 were prescribed one of these drugs before discharge.
The heart failure readmission and all-cause mortality rates were significantly higher among those who were not started on an ACE inhibitor or ARB before discharge: The 30-day heart failure readmission rate was 14% among those who did not receive an ACE inhibitor or ARB, compared with 7% of those who did – a 48% reduced risk, said Dr. Kumar Sanam, a heart failure fellow at the University of Alabama, Birmingham, at the annual meeting of the American College of Cardiology.
The all-cause readmission rate within 30 days among patients discharged without an ACE inhibitor or ARB was also significantly higher, at 24%, compared with 18% of those discharged with an ACE or an ARB, a relative risk reduction of 26%. The risk of all-cause mortality was reduced by 44% among those prescribed an ACE inhibitor or ARB, Dr. Sanam said.
Under the Affordable Care Act, hospitals will be penalized for above-average, all-cause 30-day readmission rates, he noted, and these findings highlight how the use of treatment recommended in evidence-based guidelines "could be used to reduce a costly health care problem," in the United States, Dr. Sanam said. An estimated one in four patients hospitalized with heart failure return to the hospital within 30 days, and heart failure is the most common cause of 30-day all-cause readmissions, he noted.
Dr. Sanam had no disclosures.
WASHINGTON – Patients with acute heart failure who were discharged on an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker were significantly less likely to be readmitted to the hospital within 30 days of discharge than patients who were not prescribed these drugs, in a retrospective study of Medicare beneficiaries.
Using data from the Alabama Heart Failure Project, the study looked at hospital readmission rates in 1,348 patients with acute decompensated heart failure and an ejection fraction under 45%, discharged from 106 hospitals in the United States. Their mean age was 75 years, they had similar renal function, they were on various baseline cardiac medications, and they had no contraindications for angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) treatment. Of these patients, 734 were prescribed one of these drugs before discharge.
The heart failure readmission and all-cause mortality rates were significantly higher among those who were not started on an ACE inhibitor or ARB before discharge: The 30-day heart failure readmission rate was 14% among those who did not receive an ACE inhibitor or ARB, compared with 7% of those who did – a 48% reduced risk, said Dr. Kumar Sanam, a heart failure fellow at the University of Alabama, Birmingham, at the annual meeting of the American College of Cardiology.
The all-cause readmission rate within 30 days among patients discharged without an ACE inhibitor or ARB was also significantly higher, at 24%, compared with 18% of those discharged with an ACE or an ARB, a relative risk reduction of 26%. The risk of all-cause mortality was reduced by 44% among those prescribed an ACE inhibitor or ARB, Dr. Sanam said.
Under the Affordable Care Act, hospitals will be penalized for above-average, all-cause 30-day readmission rates, he noted, and these findings highlight how the use of treatment recommended in evidence-based guidelines "could be used to reduce a costly health care problem," in the United States, Dr. Sanam said. An estimated one in four patients hospitalized with heart failure return to the hospital within 30 days, and heart failure is the most common cause of 30-day all-cause readmissions, he noted.
Dr. Sanam had no disclosures.
WASHINGTON – Patients with acute heart failure who were discharged on an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker were significantly less likely to be readmitted to the hospital within 30 days of discharge than patients who were not prescribed these drugs, in a retrospective study of Medicare beneficiaries.
Using data from the Alabama Heart Failure Project, the study looked at hospital readmission rates in 1,348 patients with acute decompensated heart failure and an ejection fraction under 45%, discharged from 106 hospitals in the United States. Their mean age was 75 years, they had similar renal function, they were on various baseline cardiac medications, and they had no contraindications for angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) treatment. Of these patients, 734 were prescribed one of these drugs before discharge.
The heart failure readmission and all-cause mortality rates were significantly higher among those who were not started on an ACE inhibitor or ARB before discharge: The 30-day heart failure readmission rate was 14% among those who did not receive an ACE inhibitor or ARB, compared with 7% of those who did – a 48% reduced risk, said Dr. Kumar Sanam, a heart failure fellow at the University of Alabama, Birmingham, at the annual meeting of the American College of Cardiology.
The all-cause readmission rate within 30 days among patients discharged without an ACE inhibitor or ARB was also significantly higher, at 24%, compared with 18% of those discharged with an ACE or an ARB, a relative risk reduction of 26%. The risk of all-cause mortality was reduced by 44% among those prescribed an ACE inhibitor or ARB, Dr. Sanam said.
Under the Affordable Care Act, hospitals will be penalized for above-average, all-cause 30-day readmission rates, he noted, and these findings highlight how the use of treatment recommended in evidence-based guidelines "could be used to reduce a costly health care problem," in the United States, Dr. Sanam said. An estimated one in four patients hospitalized with heart failure return to the hospital within 30 days, and heart failure is the most common cause of 30-day all-cause readmissions, he noted.
Dr. Sanam had no disclosures.
AT ACC 14
Major finding: Heart failure patients discharged on an ARB or ACE inhibitor had half the 30-day heart failure readmissions rate of those who were not on the drugs at discharge, at 7% and 14%, respectively.
Data source: An analysis of Medicare data from the Alabama Heart Failure Project.
Disclosures: Dr. Sanam had no disclosures.
