Heart Failure

ROME  – Unrecognized heart failure is common among older patients with type 2 diabetes, on the basis of a study of 581 Dutch diabetes patients.

A comprehensive screening examination and assessment of Dutch patients with type 2 diabetes who were at least 60 years old and had no prior history of heart failure identified 161 patients (28%) with heart failure, Dr. Leandra J.M. Boonman-de Winter and her associates reported in a poster at the annual meeting of the European Association for Cardiovascular Prevention and Rehabilitation*.

The newly identified heart failure patients included 28 (5% of the total group screened) with reduced left ventricular function and 133 (23%) with preserved left ventricular function, said Dr. Boonman-de Winter, a researcher at University Medical Center in Utrecht, the Netherlands, and her associates.

To identify these heart failure cases, the researchers performed an extensive work-up on each patient with type 2 diabetes, including a medical history, physical examination, ECG, and echocardiography. A panel of expert cardiologists made the diagnosis of heart failure using criteria of the European Society for Cardiology (Eur. Heart J. 2012;33:1787-847).

The researchers also performed a multivariate analysis to identify demographic and clinical factors that significantly linked with the presence of heart failure in the patients with diabetes. Dyspnea or fatigue linked with a sixfold increased prevalence of heart failure; ankle edema or nocturia, a history of ischemic heart disease, and age greater than 75 years old each linked with a doubled heart-failure prevalence; and hypertension linked with a 70% increased prevalence of heart failure.

These five factors together could account for 80% of the heart failure cases found among the patients with type 2 diabetes, the researchers reported. They recommended using these five factors to identify older patients with diabetes to more thoroughly screen for heart failure.

Dr. Boonman-de Winter and her associates said that they had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction, 5/29/2013: An earlier version of this story misstated the meeting name.

ROME  – Unrecognized heart failure is common among older patients with type 2 diabetes, on the basis of a study of 581 Dutch diabetes patients.

A comprehensive screening examination and assessment of Dutch patients with type 2 diabetes who were at least 60 years old and had no prior history of heart failure identified 161 patients (28%) with heart failure, Dr. Leandra J.M. Boonman-de Winter and her associates reported in a poster at the annual meeting of the European Association for Cardiovascular Prevention and Rehabilitation*.

The newly identified heart failure patients included 28 (5% of the total group screened) with reduced left ventricular function and 133 (23%) with preserved left ventricular function, said Dr. Boonman-de Winter, a researcher at University Medical Center in Utrecht, the Netherlands, and her associates.

To identify these heart failure cases, the researchers performed an extensive work-up on each patient with type 2 diabetes, including a medical history, physical examination, ECG, and echocardiography. A panel of expert cardiologists made the diagnosis of heart failure using criteria of the European Society for Cardiology (Eur. Heart J. 2012;33:1787-847).

The researchers also performed a multivariate analysis to identify demographic and clinical factors that significantly linked with the presence of heart failure in the patients with diabetes. Dyspnea or fatigue linked with a sixfold increased prevalence of heart failure; ankle edema or nocturia, a history of ischemic heart disease, and age greater than 75 years old each linked with a doubled heart-failure prevalence; and hypertension linked with a 70% increased prevalence of heart failure.

These five factors together could account for 80% of the heart failure cases found among the patients with type 2 diabetes, the researchers reported. They recommended using these five factors to identify older patients with diabetes to more thoroughly screen for heart failure.

Dr. Boonman-de Winter and her associates said that they had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction, 5/29/2013: An earlier version of this story misstated the meeting name.

ROME  – Unrecognized heart failure is common among older patients with type 2 diabetes, on the basis of a study of 581 Dutch diabetes patients.

A comprehensive screening examination and assessment of Dutch patients with type 2 diabetes who were at least 60 years old and had no prior history of heart failure identified 161 patients (28%) with heart failure, Dr. Leandra J.M. Boonman-de Winter and her associates reported in a poster at the annual meeting of the European Association for Cardiovascular Prevention and Rehabilitation*.

The newly identified heart failure patients included 28 (5% of the total group screened) with reduced left ventricular function and 133 (23%) with preserved left ventricular function, said Dr. Boonman-de Winter, a researcher at University Medical Center in Utrecht, the Netherlands, and her associates.

To identify these heart failure cases, the researchers performed an extensive work-up on each patient with type 2 diabetes, including a medical history, physical examination, ECG, and echocardiography. A panel of expert cardiologists made the diagnosis of heart failure using criteria of the European Society for Cardiology (Eur. Heart J. 2012;33:1787-847).

The researchers also performed a multivariate analysis to identify demographic and clinical factors that significantly linked with the presence of heart failure in the patients with diabetes. Dyspnea or fatigue linked with a sixfold increased prevalence of heart failure; ankle edema or nocturia, a history of ischemic heart disease, and age greater than 75 years old each linked with a doubled heart-failure prevalence; and hypertension linked with a 70% increased prevalence of heart failure.

These five factors together could account for 80% of the heart failure cases found among the patients with type 2 diabetes, the researchers reported. They recommended using these five factors to identify older patients with diabetes to more thoroughly screen for heart failure.

Dr. Boonman-de Winter and her associates said that they had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction, 5/29/2013: An earlier version of this story misstated the meeting name.

Among patients receiving an implantable cardioverter-defibrillator for primary prevention who don’t have indications for pacing, the use of a dual-chamber rather than a single-chamber ICD doesn’t appear to confer any advantage, according to a report in the May 15 issue of JAMA.

In a nationwide retrospective cohort study involving over 32,000 such patients, there was no significant difference between patients who received single-chamber devices and those who received dual-chamber devices in 1-year mortality, rate of hospitalization for any cause, or rate of hospitalization for heart failure, said Dr. Pamela N. Peterson of the Denver Health Medical Center, and her associates.

However, there was an important disadvantage with the dual-chamber ICDs: They carried a higher rate of complications such as infection and lead displacement. They also were more costly than were single-chamber devices because placement is more complex, and time-consuming and later mechanical dysfunction is more common.

"Therefore, among patients without clear pacing indications, the decision to implant a dual-chamber ICD for primary prevention should be considered carefully," Dr. Peterson and her colleagues said.

They performed this cohort study because of the "lack of clarity" regarding the long-term safety and outcomes of dual-chamber ICDs compared with single-chamber ICDs. "Despite the absence of compelling evidence to support these more costly devices ... current practice is highly variable," they noted.

The investigators used data from the National Cardiovascular Data Registry’s ICD component to identify 32,034 patients who received ICDs at 1,270 hospitals across the country during 2006-2009. A total of 19,788 (62%) received a dual-chamber device and 12,246 (38%) a single-chamber device.

All of these study subjects received the ICDs for primary prevention only, and none had any indications for pacing.

The initial data analysis examined rates of any serious complications, including pneumothorax requiring a chest tube (within 30 days of the placement), hematoma requiring a blood transfusion or evacuation (within 30 days), cardiac tamponade (within 30 days), lead revision (within 90 days), device-related infection (within 90 days), and recurrent ICD implantation (within 90 days).

The unadjusted rate of any such complications were significantly higher with dual-chamber ICDs. The largest difference between single- and dual-chamber devices occurred with the most common complication in this study: mechanical dysfunction of the ICD requiring repeat operation for system revision.

At 1 year, the unadjusted rates of hospitalization for heart failure (14.7% vs 15.5%), of hospitalization for all causes (43.8% vs. 44.9%), and of mortality (9.9% vs. 10.1%) were similar between patients who received a single-chamber device and those who received a dual-chamber device.

The investigators then performed a propensity-matched analysis involving 11,619 patients who received a single-chamber and the same number who received a dual-chamber ICD. In this analysis, the rate of serious complications also was significantly lower with single-chamber devices (3.5%) than with dual-chamber devices (4.7%), with the largest absolute difference again occurring in mechanical complications requiring system revision.

Again, rates of all-cause hospitalization, heart failure hospitalization, and mortality were comparable between the two study groups at 1 year, the investigators said (JAMA 2013;309:2025-34).

The results remained consistent in further analyses of clinically important subgroups of patients, regardless of age, sex, or the presence or absence of renal dysfunction at the time of operation.

These findings indicate that dual-chamber ICDs "do not appear to offer any clinical benefit" over single-chamber ICDs, at least with regard to death or hospital readmission, Dr. Peterson and her associates said.

Their study was limited in that it could not address other important outcomes, such as patients’ quality of life or the development of atrial fibrillation, because no data were available regarding these factors.

This study was supported by the Agency for Healthcare Research and Quality and the American College of Cardiology Foundation’s National Cardiovascular Data Registry. Dr. Peterson reported no financial conflicts of interest; one of her associates reported receiving grant money from Boston Scientific.

Among patients receiving an implantable cardioverter-defibrillator for primary prevention who don’t have indications for pacing, the use of a dual-chamber rather than a single-chamber ICD doesn’t appear to confer any advantage, according to a report in the May 15 issue of JAMA.

In a nationwide retrospective cohort study involving over 32,000 such patients, there was no significant difference between patients who received single-chamber devices and those who received dual-chamber devices in 1-year mortality, rate of hospitalization for any cause, or rate of hospitalization for heart failure, said Dr. Pamela N. Peterson of the Denver Health Medical Center, and her associates.

However, there was an important disadvantage with the dual-chamber ICDs: They carried a higher rate of complications such as infection and lead displacement. They also were more costly than were single-chamber devices because placement is more complex, and time-consuming and later mechanical dysfunction is more common.

"Therefore, among patients without clear pacing indications, the decision to implant a dual-chamber ICD for primary prevention should be considered carefully," Dr. Peterson and her colleagues said.

They performed this cohort study because of the "lack of clarity" regarding the long-term safety and outcomes of dual-chamber ICDs compared with single-chamber ICDs. "Despite the absence of compelling evidence to support these more costly devices ... current practice is highly variable," they noted.

The investigators used data from the National Cardiovascular Data Registry’s ICD component to identify 32,034 patients who received ICDs at 1,270 hospitals across the country during 2006-2009. A total of 19,788 (62%) received a dual-chamber device and 12,246 (38%) a single-chamber device.

All of these study subjects received the ICDs for primary prevention only, and none had any indications for pacing.

The initial data analysis examined rates of any serious complications, including pneumothorax requiring a chest tube (within 30 days of the placement), hematoma requiring a blood transfusion or evacuation (within 30 days), cardiac tamponade (within 30 days), lead revision (within 90 days), device-related infection (within 90 days), and recurrent ICD implantation (within 90 days).

The unadjusted rate of any such complications were significantly higher with dual-chamber ICDs. The largest difference between single- and dual-chamber devices occurred with the most common complication in this study: mechanical dysfunction of the ICD requiring repeat operation for system revision.

At 1 year, the unadjusted rates of hospitalization for heart failure (14.7% vs 15.5%), of hospitalization for all causes (43.8% vs. 44.9%), and of mortality (9.9% vs. 10.1%) were similar between patients who received a single-chamber device and those who received a dual-chamber device.

The investigators then performed a propensity-matched analysis involving 11,619 patients who received a single-chamber and the same number who received a dual-chamber ICD. In this analysis, the rate of serious complications also was significantly lower with single-chamber devices (3.5%) than with dual-chamber devices (4.7%), with the largest absolute difference again occurring in mechanical complications requiring system revision.

Again, rates of all-cause hospitalization, heart failure hospitalization, and mortality were comparable between the two study groups at 1 year, the investigators said (JAMA 2013;309:2025-34).

The results remained consistent in further analyses of clinically important subgroups of patients, regardless of age, sex, or the presence or absence of renal dysfunction at the time of operation.

These findings indicate that dual-chamber ICDs "do not appear to offer any clinical benefit" over single-chamber ICDs, at least with regard to death or hospital readmission, Dr. Peterson and her associates said.

Their study was limited in that it could not address other important outcomes, such as patients’ quality of life or the development of atrial fibrillation, because no data were available regarding these factors.

This study was supported by the Agency for Healthcare Research and Quality and the American College of Cardiology Foundation’s National Cardiovascular Data Registry. Dr. Peterson reported no financial conflicts of interest; one of her associates reported receiving grant money from Boston Scientific.

Among patients receiving an implantable cardioverter-defibrillator for primary prevention who don’t have indications for pacing, the use of a dual-chamber rather than a single-chamber ICD doesn’t appear to confer any advantage, according to a report in the May 15 issue of JAMA.

In a nationwide retrospective cohort study involving over 32,000 such patients, there was no significant difference between patients who received single-chamber devices and those who received dual-chamber devices in 1-year mortality, rate of hospitalization for any cause, or rate of hospitalization for heart failure, said Dr. Pamela N. Peterson of the Denver Health Medical Center, and her associates.

However, there was an important disadvantage with the dual-chamber ICDs: They carried a higher rate of complications such as infection and lead displacement. They also were more costly than were single-chamber devices because placement is more complex, and time-consuming and later mechanical dysfunction is more common.

"Therefore, among patients without clear pacing indications, the decision to implant a dual-chamber ICD for primary prevention should be considered carefully," Dr. Peterson and her colleagues said.

They performed this cohort study because of the "lack of clarity" regarding the long-term safety and outcomes of dual-chamber ICDs compared with single-chamber ICDs. "Despite the absence of compelling evidence to support these more costly devices ... current practice is highly variable," they noted.

The investigators used data from the National Cardiovascular Data Registry’s ICD component to identify 32,034 patients who received ICDs at 1,270 hospitals across the country during 2006-2009. A total of 19,788 (62%) received a dual-chamber device and 12,246 (38%) a single-chamber device.

All of these study subjects received the ICDs for primary prevention only, and none had any indications for pacing.

The initial data analysis examined rates of any serious complications, including pneumothorax requiring a chest tube (within 30 days of the placement), hematoma requiring a blood transfusion or evacuation (within 30 days), cardiac tamponade (within 30 days), lead revision (within 90 days), device-related infection (within 90 days), and recurrent ICD implantation (within 90 days).

The unadjusted rate of any such complications were significantly higher with dual-chamber ICDs. The largest difference between single- and dual-chamber devices occurred with the most common complication in this study: mechanical dysfunction of the ICD requiring repeat operation for system revision.

At 1 year, the unadjusted rates of hospitalization for heart failure (14.7% vs 15.5%), of hospitalization for all causes (43.8% vs. 44.9%), and of mortality (9.9% vs. 10.1%) were similar between patients who received a single-chamber device and those who received a dual-chamber device.

The investigators then performed a propensity-matched analysis involving 11,619 patients who received a single-chamber and the same number who received a dual-chamber ICD. In this analysis, the rate of serious complications also was significantly lower with single-chamber devices (3.5%) than with dual-chamber devices (4.7%), with the largest absolute difference again occurring in mechanical complications requiring system revision.

Again, rates of all-cause hospitalization, heart failure hospitalization, and mortality were comparable between the two study groups at 1 year, the investigators said (JAMA 2013;309:2025-34).

The results remained consistent in further analyses of clinically important subgroups of patients, regardless of age, sex, or the presence or absence of renal dysfunction at the time of operation.

These findings indicate that dual-chamber ICDs "do not appear to offer any clinical benefit" over single-chamber ICDs, at least with regard to death or hospital readmission, Dr. Peterson and her associates said.

Their study was limited in that it could not address other important outcomes, such as patients’ quality of life or the development of atrial fibrillation, because no data were available regarding these factors.

This study was supported by the Agency for Healthcare Research and Quality and the American College of Cardiology Foundation’s National Cardiovascular Data Registry. Dr. Peterson reported no financial conflicts of interest; one of her associates reported receiving grant money from Boston Scientific.

Americans should lower sodium consumption to optimize their health – but not below levels of 2,300 mg per day, according to a new report from the Institute of Medicine.

People aged 51 years and older, African-Americans, and those with hypertension, diabetes, or chronic kidney disease can follow the same advice, according to authors of the report, released during a webinar May 14.

© Georges Lievre / Fotolia.com

That recommendation is a departure from the current Dietary Guidelines for Americans from the U.S. Department of Health and Human Services, which recommends that these higher-risk groups limit sodium intake to 1,500 mg daily. The HHS guidelines recommend that most other people aged 14-50 years limit sodium intake to 2,300 mg per day.

On average, Americans consume 3,400 mg or more of sodium a day (equivalent to 1.5 teaspoons of salt), despite efforts over the past few decades to reduce sodium consumption, according to the IOM report, which was sponsored by the Centers for Disease Control and Prevention.

"We found no consistent evidence to support an association between sodium intake and either a beneficial or adverse effect on most direct health outcomes," said Dr. Brian L. Strom, George S. Pepper Professor of Public Health and Preventive Medicine at the University of Pennsylvania, Philadelphia, who chaired the committee that released the report.

The committee did not suggest an optimal target range for sodium consumption.

Dr. Strom and his colleagues reviewed medical studies from 2003 to 2012 that evaluated the direct impact of sodium intake on outcomes such as heart disease and death. Although the studies varied widely in the quality of their methodology and data collection, the report’s authors came to the following conclusions:

• There was a positive relationship between higher levels of sodium and risk of heart disease, consistent with previous research looking at sodium’s effects on blood pressure.

• There were insufficient data to determine if lowering sodium intake below 2,300 mg/day conferred any increase or decrease in the risk of heart disease, stroke, or death.

• Sodium intake of 1,840 mg/day or less may increase the risk of adverse health effects such as cardiovascular events or death among people with mid- to late-stage heart failure receiving aggressive treatment.

• Health outcomes studies provide little evidence about the effects of low sodium intake among those with diabetes, kidney disease, and heart disease, suggesting that people affected by these conditions could follow recommendations for the general public.

But the recommendations prompted calls for caution by some health experts.

The IOM report included "weak studies with numerous problems" and did not include evidence on the effects of sodium reduction on blood pressure, "a key determinant of health and the largest determinant of preventable mortality worldwide," Dr. Lawrence Appel, director of the Welch Center for Prevention, Epidemiology, and Clinical Research at Johns Hopkins University, Baltimore, said in an interview.

Dr. Appel said he still supports the recommendations of the Dietary Guidelines, which he helped create. "Middle- and older-aged adults, African Americans, and patients with hypertension, diabetes, and chronic kidney disease are those at greatest risk for blood pressure–related heart disease and stroke," he said, and they stand to benefit from keeping sodium levels to 1,500 mg/day or less.

Americans should lower sodium consumption to optimize their health – but not below levels of 2,300 mg per day, according to a new report from the Institute of Medicine.

People aged 51 years and older, African-Americans, and those with hypertension, diabetes, or chronic kidney disease can follow the same advice, according to authors of the report, released during a webinar May 14.

© Georges Lievre / Fotolia.com

That recommendation is a departure from the current Dietary Guidelines for Americans from the U.S. Department of Health and Human Services, which recommends that these higher-risk groups limit sodium intake to 1,500 mg daily. The HHS guidelines recommend that most other people aged 14-50 years limit sodium intake to 2,300 mg per day.

On average, Americans consume 3,400 mg or more of sodium a day (equivalent to 1.5 teaspoons of salt), despite efforts over the past few decades to reduce sodium consumption, according to the IOM report, which was sponsored by the Centers for Disease Control and Prevention.

"We found no consistent evidence to support an association between sodium intake and either a beneficial or adverse effect on most direct health outcomes," said Dr. Brian L. Strom, George S. Pepper Professor of Public Health and Preventive Medicine at the University of Pennsylvania, Philadelphia, who chaired the committee that released the report.

The committee did not suggest an optimal target range for sodium consumption.

Dr. Strom and his colleagues reviewed medical studies from 2003 to 2012 that evaluated the direct impact of sodium intake on outcomes such as heart disease and death. Although the studies varied widely in the quality of their methodology and data collection, the report’s authors came to the following conclusions:

• There was a positive relationship between higher levels of sodium and risk of heart disease, consistent with previous research looking at sodium’s effects on blood pressure.

• There were insufficient data to determine if lowering sodium intake below 2,300 mg/day conferred any increase or decrease in the risk of heart disease, stroke, or death.

• Sodium intake of 1,840 mg/day or less may increase the risk of adverse health effects such as cardiovascular events or death among people with mid- to late-stage heart failure receiving aggressive treatment.

• Health outcomes studies provide little evidence about the effects of low sodium intake among those with diabetes, kidney disease, and heart disease, suggesting that people affected by these conditions could follow recommendations for the general public.

But the recommendations prompted calls for caution by some health experts.

The IOM report included "weak studies with numerous problems" and did not include evidence on the effects of sodium reduction on blood pressure, "a key determinant of health and the largest determinant of preventable mortality worldwide," Dr. Lawrence Appel, director of the Welch Center for Prevention, Epidemiology, and Clinical Research at Johns Hopkins University, Baltimore, said in an interview.

Dr. Appel said he still supports the recommendations of the Dietary Guidelines, which he helped create. "Middle- and older-aged adults, African Americans, and patients with hypertension, diabetes, and chronic kidney disease are those at greatest risk for blood pressure–related heart disease and stroke," he said, and they stand to benefit from keeping sodium levels to 1,500 mg/day or less.

Americans should lower sodium consumption to optimize their health – but not below levels of 2,300 mg per day, according to a new report from the Institute of Medicine.

People aged 51 years and older, African-Americans, and those with hypertension, diabetes, or chronic kidney disease can follow the same advice, according to authors of the report, released during a webinar May 14.

© Georges Lievre / Fotolia.com

That recommendation is a departure from the current Dietary Guidelines for Americans from the U.S. Department of Health and Human Services, which recommends that these higher-risk groups limit sodium intake to 1,500 mg daily. The HHS guidelines recommend that most other people aged 14-50 years limit sodium intake to 2,300 mg per day.

On average, Americans consume 3,400 mg or more of sodium a day (equivalent to 1.5 teaspoons of salt), despite efforts over the past few decades to reduce sodium consumption, according to the IOM report, which was sponsored by the Centers for Disease Control and Prevention.

"We found no consistent evidence to support an association between sodium intake and either a beneficial or adverse effect on most direct health outcomes," said Dr. Brian L. Strom, George S. Pepper Professor of Public Health and Preventive Medicine at the University of Pennsylvania, Philadelphia, who chaired the committee that released the report.

The committee did not suggest an optimal target range for sodium consumption.

Dr. Strom and his colleagues reviewed medical studies from 2003 to 2012 that evaluated the direct impact of sodium intake on outcomes such as heart disease and death. Although the studies varied widely in the quality of their methodology and data collection, the report’s authors came to the following conclusions:

• There was a positive relationship between higher levels of sodium and risk of heart disease, consistent with previous research looking at sodium’s effects on blood pressure.

• There were insufficient data to determine if lowering sodium intake below 2,300 mg/day conferred any increase or decrease in the risk of heart disease, stroke, or death.

• Sodium intake of 1,840 mg/day or less may increase the risk of adverse health effects such as cardiovascular events or death among people with mid- to late-stage heart failure receiving aggressive treatment.

• Health outcomes studies provide little evidence about the effects of low sodium intake among those with diabetes, kidney disease, and heart disease, suggesting that people affected by these conditions could follow recommendations for the general public.

But the recommendations prompted calls for caution by some health experts.

The IOM report included "weak studies with numerous problems" and did not include evidence on the effects of sodium reduction on blood pressure, "a key determinant of health and the largest determinant of preventable mortality worldwide," Dr. Lawrence Appel, director of the Welch Center for Prevention, Epidemiology, and Clinical Research at Johns Hopkins University, Baltimore, said in an interview.

Dr. Appel said he still supports the recommendations of the Dietary Guidelines, which he helped create. "Middle- and older-aged adults, African Americans, and patients with hypertension, diabetes, and chronic kidney disease are those at greatest risk for blood pressure–related heart disease and stroke," he said, and they stand to benefit from keeping sodium levels to 1,500 mg/day or less.

ROME – A home-based cardiac rehabilitation program that relies on telemonitoring safely allowed effective training of about 800 elderly cardiac patients at one center in Poland since 2006.

"The advantages of telerehabilitation are the convenience and easy access for elderly patients," Dr. Ewa Piotrowicz said at the annual meeting of the European Association for Cardiovascular Prevention and Rehabilitation*. Telerehabilitation "fosters greater patient independence than hospital-based exercise training, and may reduce patient commute time and costs. Telemedicine may overcome some of the barriers related to aging.

"In our opinion, home-based cardiac rehabilitation is the best option" for older patients, said Dr. Piotrowicz, a cardiologist and head of the telecardiology center of the Institute of Cardiology in Warsaw.

Mitchel L. Zoler/IMNG Medical Media

A key to safe and successful home-based rehabilitation training for elderly cardiac patients is a thorough baseline examination to assess cardiac stability. "We don’t do telerehabilitation on unstable patients," she said in an interview. The other major feature is thorough monitoring by a telephone conversation and telephone transmission of vital recordings immediately before and after each at-home rehabilitation session. "Before and after every session the patient sends an ECG recording and answers a series of questions," she explained.

During the 7 years that the institute has run the program, it has enrolled about 500 lower-risk and 300 higher-risk patients, with about 50 in the program at any given time. At entry, each patient undergoes assessment by ECG, an echocardiography examination, 24-hour Holter blood pressure monitoring, and a cardiopulmonary exercise test.

The rehabilitation program involves an individualized exercise training program, and launches with a few sessions at the hospital along with educational sessions. The patient then continues the basic phase of the program with five daily sessions per week for 8 weeks. The program includes walking, running, interval training, and breathing training. Before and immediately after each daily session the patient speaks with a physician at the center, answering questions and sending information on ECG, heart rate, blood pressure, weight, oxygen saturation, respiration rate, and medications taken. Patients must receive approval from a physician before each exercise session starts.

The program achieved a high compliance level. Dr. Piotrowicz said that 95% of the 800 participants completed their 8-week programs. Following that, patients are encouraged to continue exercising on their own.

In 2010, she and her associates reported results from a formal, controlled assessment of compliance among 152 patients with heart failure who were randomized to either a home-based, telemonitored rehabilitation program or a more conventional outpatient program. The home-based telemonitored program produced similar clinical and quality of life improvements compared with the program for the control patients, and the 77 patients randomized to telemonitoring had 100% compliance with the 8-week rehabilitation program, compared with a 20% attrition rate among the patients enrolled in a standard outpatient rehabilitation program (Eur. J. Heart Fail. 2010;12:164-71). Dr. Piotrowicz attributed the high compliance to the daily contact that patients maintain with their health care providers.

"Telerehabilitation is a chance for implementing cardiac rehabilitation, especially in chronic heart failure patients," she said. The next step is a multicenter study of this approach, she added.

Dr. Piotrowicz said that she had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction, 5/29/2013: An earlier version of this story misstated the name of the European Association for Cardiovascular Prevention and Rehabilitation.

ROME – A home-based cardiac rehabilitation program that relies on telemonitoring safely allowed effective training of about 800 elderly cardiac patients at one center in Poland since 2006.

"The advantages of telerehabilitation are the convenience and easy access for elderly patients," Dr. Ewa Piotrowicz said at the annual meeting of the European Association for Cardiovascular Prevention and Rehabilitation*. Telerehabilitation "fosters greater patient independence than hospital-based exercise training, and may reduce patient commute time and costs. Telemedicine may overcome some of the barriers related to aging.

"In our opinion, home-based cardiac rehabilitation is the best option" for older patients, said Dr. Piotrowicz, a cardiologist and head of the telecardiology center of the Institute of Cardiology in Warsaw.

Mitchel L. Zoler/IMNG Medical Media

A key to safe and successful home-based rehabilitation training for elderly cardiac patients is a thorough baseline examination to assess cardiac stability. "We don’t do telerehabilitation on unstable patients," she said in an interview. The other major feature is thorough monitoring by a telephone conversation and telephone transmission of vital recordings immediately before and after each at-home rehabilitation session. "Before and after every session the patient sends an ECG recording and answers a series of questions," she explained.

During the 7 years that the institute has run the program, it has enrolled about 500 lower-risk and 300 higher-risk patients, with about 50 in the program at any given time. At entry, each patient undergoes assessment by ECG, an echocardiography examination, 24-hour Holter blood pressure monitoring, and a cardiopulmonary exercise test.

The rehabilitation program involves an individualized exercise training program, and launches with a few sessions at the hospital along with educational sessions. The patient then continues the basic phase of the program with five daily sessions per week for 8 weeks. The program includes walking, running, interval training, and breathing training. Before and immediately after each daily session the patient speaks with a physician at the center, answering questions and sending information on ECG, heart rate, blood pressure, weight, oxygen saturation, respiration rate, and medications taken. Patients must receive approval from a physician before each exercise session starts.

The program achieved a high compliance level. Dr. Piotrowicz said that 95% of the 800 participants completed their 8-week programs. Following that, patients are encouraged to continue exercising on their own.

In 2010, she and her associates reported results from a formal, controlled assessment of compliance among 152 patients with heart failure who were randomized to either a home-based, telemonitored rehabilitation program or a more conventional outpatient program. The home-based telemonitored program produced similar clinical and quality of life improvements compared with the program for the control patients, and the 77 patients randomized to telemonitoring had 100% compliance with the 8-week rehabilitation program, compared with a 20% attrition rate among the patients enrolled in a standard outpatient rehabilitation program (Eur. J. Heart Fail. 2010;12:164-71). Dr. Piotrowicz attributed the high compliance to the daily contact that patients maintain with their health care providers.

"Telerehabilitation is a chance for implementing cardiac rehabilitation, especially in chronic heart failure patients," she said. The next step is a multicenter study of this approach, she added.

Dr. Piotrowicz said that she had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction, 5/29/2013: An earlier version of this story misstated the name of the European Association for Cardiovascular Prevention and Rehabilitation.

ROME – A home-based cardiac rehabilitation program that relies on telemonitoring safely allowed effective training of about 800 elderly cardiac patients at one center in Poland since 2006.

"The advantages of telerehabilitation are the convenience and easy access for elderly patients," Dr. Ewa Piotrowicz said at the annual meeting of the European Association for Cardiovascular Prevention and Rehabilitation*. Telerehabilitation "fosters greater patient independence than hospital-based exercise training, and may reduce patient commute time and costs. Telemedicine may overcome some of the barriers related to aging.

"In our opinion, home-based cardiac rehabilitation is the best option" for older patients, said Dr. Piotrowicz, a cardiologist and head of the telecardiology center of the Institute of Cardiology in Warsaw.

Mitchel L. Zoler/IMNG Medical Media

A key to safe and successful home-based rehabilitation training for elderly cardiac patients is a thorough baseline examination to assess cardiac stability. "We don’t do telerehabilitation on unstable patients," she said in an interview. The other major feature is thorough monitoring by a telephone conversation and telephone transmission of vital recordings immediately before and after each at-home rehabilitation session. "Before and after every session the patient sends an ECG recording and answers a series of questions," she explained.

During the 7 years that the institute has run the program, it has enrolled about 500 lower-risk and 300 higher-risk patients, with about 50 in the program at any given time. At entry, each patient undergoes assessment by ECG, an echocardiography examination, 24-hour Holter blood pressure monitoring, and a cardiopulmonary exercise test.

The rehabilitation program involves an individualized exercise training program, and launches with a few sessions at the hospital along with educational sessions. The patient then continues the basic phase of the program with five daily sessions per week for 8 weeks. The program includes walking, running, interval training, and breathing training. Before and immediately after each daily session the patient speaks with a physician at the center, answering questions and sending information on ECG, heart rate, blood pressure, weight, oxygen saturation, respiration rate, and medications taken. Patients must receive approval from a physician before each exercise session starts.

The program achieved a high compliance level. Dr. Piotrowicz said that 95% of the 800 participants completed their 8-week programs. Following that, patients are encouraged to continue exercising on their own.

In 2010, she and her associates reported results from a formal, controlled assessment of compliance among 152 patients with heart failure who were randomized to either a home-based, telemonitored rehabilitation program or a more conventional outpatient program. The home-based telemonitored program produced similar clinical and quality of life improvements compared with the program for the control patients, and the 77 patients randomized to telemonitoring had 100% compliance with the 8-week rehabilitation program, compared with a 20% attrition rate among the patients enrolled in a standard outpatient rehabilitation program (Eur. J. Heart Fail. 2010;12:164-71). Dr. Piotrowicz attributed the high compliance to the daily contact that patients maintain with their health care providers.

"Telerehabilitation is a chance for implementing cardiac rehabilitation, especially in chronic heart failure patients," she said. The next step is a multicenter study of this approach, she added.

Dr. Piotrowicz said that she had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction, 5/29/2013: An earlier version of this story misstated the name of the European Association for Cardiovascular Prevention and Rehabilitation.

ROME – Starting cardiac rehabilitation sessions within 2 weeks of an acute myocardial infarction is safe and can improve cardiac perfusion and function, according to results of a randomized, controlled study of 46 patients who had residual myocardial ischemia following an MI and percutaneous coronary revascularization.

"Exercise-induced changes in myocardial perfusion and function were associated with an absence of unfavorable left-ventricular remodeling and an improved cardiovascular functional capacity," Dr. Francesco Giallauria said at the European Association for Cardiovascular Prevention and Rehabilitation* annual meeting. He hypothesized that exercise training begun soon after an MI improves myocardial perfusion by inducing coronary vascular adaptation or enhancing development of collateral cardiac vessels.

Mitchel L. Zoler/IMNG Medical Media

The study began with patients who underwent percutaneous coronary intervention (PCI) following an acute ST-elevation MI who were then assessed by dipyridamole stress and gated single-photon emission CT (SPECT) using labeled sestamibi. All 46 included patients had a significant amount of residual myocardial ischemia despite PCI, presumably caused by inadequate perfusion in myocardial regions not vascularized by the PCI-treated coronaries, said Dr. Giallauria, a cardiologist at the University of Naples (Italy). All patients also underwent a cardiopulmonary exercise test at baseline to determine their peak exercise capacity.

The researchers then randomized the patients. Twenty-five entered a hospital outpatient program of supervised, 30-minutes sessions of bicycle exercise three times a week, with an exercise target during each session of 60%-70% of their peak exercise capacity. The program began within 2 weeks of their acute MI. The remaining 21 patients served as controls and received just instructions about maintaining physical exercise and lifestyle modification.

The exercise rehabilitation program continued for 6 months, when all 46 patients underwent a follow-up examination of their myocardial perfusion with gated SPECT and follow-up cardiopulmonary stress testing. The average age of the patients was 54 years, and 87% were men.

The results showed that after 6 months, patients who underwent exercise training had an average 29% increase in peak exercise capacity and a 10% average rise in their peak heart rate compared with baseline, both statistically significant differences. Results from the serial SPECT studies showed that left ventricular ejection fraction rose from an average of 48% at baseline to 52% in the patients who underwent exercise training, a statistically significant rise, and their wall motion and wall thickness scores showed improvements in cardiac shape and function compared with baseline, all differences that were statistically significant. In contrast, the control patients had no significant changes for any of these exercise or cardiac measures during the 6 months of follow-up.

In addition, the SPECT imaging showed that at follow-up the extent of myocardial perfusion defect and ischemia fell by about 50% in the exercise group while remaining virtually unchanged in the control patients.

Dr. Giallauria said that he had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction, 5/29/2013: An earlier version of this story misstated the name of the European Association for Cardiovascular Prevention and Rehabilitation annual conference.

ROME – Starting cardiac rehabilitation sessions within 2 weeks of an acute myocardial infarction is safe and can improve cardiac perfusion and function, according to results of a randomized, controlled study of 46 patients who had residual myocardial ischemia following an MI and percutaneous coronary revascularization.

"Exercise-induced changes in myocardial perfusion and function were associated with an absence of unfavorable left-ventricular remodeling and an improved cardiovascular functional capacity," Dr. Francesco Giallauria said at the European Association for Cardiovascular Prevention and Rehabilitation* annual meeting. He hypothesized that exercise training begun soon after an MI improves myocardial perfusion by inducing coronary vascular adaptation or enhancing development of collateral cardiac vessels.

Mitchel L. Zoler/IMNG Medical Media

The study began with patients who underwent percutaneous coronary intervention (PCI) following an acute ST-elevation MI who were then assessed by dipyridamole stress and gated single-photon emission CT (SPECT) using labeled sestamibi. All 46 included patients had a significant amount of residual myocardial ischemia despite PCI, presumably caused by inadequate perfusion in myocardial regions not vascularized by the PCI-treated coronaries, said Dr. Giallauria, a cardiologist at the University of Naples (Italy). All patients also underwent a cardiopulmonary exercise test at baseline to determine their peak exercise capacity.

The researchers then randomized the patients. Twenty-five entered a hospital outpatient program of supervised, 30-minutes sessions of bicycle exercise three times a week, with an exercise target during each session of 60%-70% of their peak exercise capacity. The program began within 2 weeks of their acute MI. The remaining 21 patients served as controls and received just instructions about maintaining physical exercise and lifestyle modification.

The exercise rehabilitation program continued for 6 months, when all 46 patients underwent a follow-up examination of their myocardial perfusion with gated SPECT and follow-up cardiopulmonary stress testing. The average age of the patients was 54 years, and 87% were men.

The results showed that after 6 months, patients who underwent exercise training had an average 29% increase in peak exercise capacity and a 10% average rise in their peak heart rate compared with baseline, both statistically significant differences. Results from the serial SPECT studies showed that left ventricular ejection fraction rose from an average of 48% at baseline to 52% in the patients who underwent exercise training, a statistically significant rise, and their wall motion and wall thickness scores showed improvements in cardiac shape and function compared with baseline, all differences that were statistically significant. In contrast, the control patients had no significant changes for any of these exercise or cardiac measures during the 6 months of follow-up.

In addition, the SPECT imaging showed that at follow-up the extent of myocardial perfusion defect and ischemia fell by about 50% in the exercise group while remaining virtually unchanged in the control patients.

Dr. Giallauria said that he had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction, 5/29/2013: An earlier version of this story misstated the name of the European Association for Cardiovascular Prevention and Rehabilitation annual conference.

ROME – Starting cardiac rehabilitation sessions within 2 weeks of an acute myocardial infarction is safe and can improve cardiac perfusion and function, according to results of a randomized, controlled study of 46 patients who had residual myocardial ischemia following an MI and percutaneous coronary revascularization.

"Exercise-induced changes in myocardial perfusion and function were associated with an absence of unfavorable left-ventricular remodeling and an improved cardiovascular functional capacity," Dr. Francesco Giallauria said at the European Association for Cardiovascular Prevention and Rehabilitation* annual meeting. He hypothesized that exercise training begun soon after an MI improves myocardial perfusion by inducing coronary vascular adaptation or enhancing development of collateral cardiac vessels.

Mitchel L. Zoler/IMNG Medical Media

The study began with patients who underwent percutaneous coronary intervention (PCI) following an acute ST-elevation MI who were then assessed by dipyridamole stress and gated single-photon emission CT (SPECT) using labeled sestamibi. All 46 included patients had a significant amount of residual myocardial ischemia despite PCI, presumably caused by inadequate perfusion in myocardial regions not vascularized by the PCI-treated coronaries, said Dr. Giallauria, a cardiologist at the University of Naples (Italy). All patients also underwent a cardiopulmonary exercise test at baseline to determine their peak exercise capacity.

The researchers then randomized the patients. Twenty-five entered a hospital outpatient program of supervised, 30-minutes sessions of bicycle exercise three times a week, with an exercise target during each session of 60%-70% of their peak exercise capacity. The program began within 2 weeks of their acute MI. The remaining 21 patients served as controls and received just instructions about maintaining physical exercise and lifestyle modification.

The exercise rehabilitation program continued for 6 months, when all 46 patients underwent a follow-up examination of their myocardial perfusion with gated SPECT and follow-up cardiopulmonary stress testing. The average age of the patients was 54 years, and 87% were men.

The results showed that after 6 months, patients who underwent exercise training had an average 29% increase in peak exercise capacity and a 10% average rise in their peak heart rate compared with baseline, both statistically significant differences. Results from the serial SPECT studies showed that left ventricular ejection fraction rose from an average of 48% at baseline to 52% in the patients who underwent exercise training, a statistically significant rise, and their wall motion and wall thickness scores showed improvements in cardiac shape and function compared with baseline, all differences that were statistically significant. In contrast, the control patients had no significant changes for any of these exercise or cardiac measures during the 6 months of follow-up.

In addition, the SPECT imaging showed that at follow-up the extent of myocardial perfusion defect and ischemia fell by about 50% in the exercise group while remaining virtually unchanged in the control patients.

Dr. Giallauria said that he had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction, 5/29/2013: An earlier version of this story misstated the name of the European Association for Cardiovascular Prevention and Rehabilitation annual conference.

Lorcaserin, a serotonin receptor agonist approved as a weight loss agent in 2012, has been scheduled as a schedule IV drug and is expected to be available within weeks, according to the manufacturer, Arena Pharmaceuticals.

The Drug Enforcement Administration (DEA) has placed lorcaserin (Belviq) in the schedule IV category of the Controlled Substances Act, which is for drugs with "a low potential for abuse and low risk of dependence." Other schedule IV drugs are alprazolam (Xanax), diazepam (Valium), and zolpidem (Ambien). Lorcaserin will be available 30 days after the final rule on the scheduling is published in the May 8th Federal Register, according to a May 7 statement issued by Arena.

The final rule in the Federal Register says that, on the basis of a review of the available data, the DEA determined that lorcaserin has a low potential for abuse relative to schedule III drugs, such as ketamine, and that the overall abuse potential of lorcaserin is comparable to schedule IV drugs, such a zolpidem. "Abuse of lorcaserin may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III. This finding is based on the ability of lorcaserin to produce positive subjective effects at supratherapeutic doses," according to the final rule.

After two FDA advisory panel meetings, the FDA approved lorcaserin in June 2012 as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of at least 30 kg/m² (obese), or at least 27 kg/m² (overweight) with at least one weight-related comorbid condition. The drug could not be marketed until the DEA finalized its decision regarding scheduling.

Because of concerns regarding the potential for valvulopathy associated with treatment, the company’s postmarketing commitments include conducting six studies, including a long-term cardiovascular outcomes trial. The prescribing information includes a recommendation to consider discontinuing treatment if patients develop signs to symptoms indicative of valvular heart disease and to evaluate patients for valvulopathy. Lorcaserin activates the serotonin 2C receptor, but at the approved dose of 10 mg twice a day, "does not appear to activate the serotonin 2B receptor," the FDA said in the June 27, 2012, approval announcement.

Weight-loss drugs fenfluramine and dexfenfluramine were taken off the market in 1997 after they were associated with valvular damage that was thought to be related to activation of the serotonin 2B receptor on cardiac tissue, according to the FDA.

Arena will be marketing lorcaserin as Belviq.

emechcatie@frontlinemedcom.com

Lorcaserin, a serotonin receptor agonist approved as a weight loss agent in 2012, has been scheduled as a schedule IV drug and is expected to be available within weeks, according to the manufacturer, Arena Pharmaceuticals.

The Drug Enforcement Administration (DEA) has placed lorcaserin (Belviq) in the schedule IV category of the Controlled Substances Act, which is for drugs with "a low potential for abuse and low risk of dependence." Other schedule IV drugs are alprazolam (Xanax), diazepam (Valium), and zolpidem (Ambien). Lorcaserin will be available 30 days after the final rule on the scheduling is published in the May 8th Federal Register, according to a May 7 statement issued by Arena.

The final rule in the Federal Register says that, on the basis of a review of the available data, the DEA determined that lorcaserin has a low potential for abuse relative to schedule III drugs, such as ketamine, and that the overall abuse potential of lorcaserin is comparable to schedule IV drugs, such a zolpidem. "Abuse of lorcaserin may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III. This finding is based on the ability of lorcaserin to produce positive subjective effects at supratherapeutic doses," according to the final rule.

After two FDA advisory panel meetings, the FDA approved lorcaserin in June 2012 as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of at least 30 kg/m² (obese), or at least 27 kg/m² (overweight) with at least one weight-related comorbid condition. The drug could not be marketed until the DEA finalized its decision regarding scheduling.

Because of concerns regarding the potential for valvulopathy associated with treatment, the company’s postmarketing commitments include conducting six studies, including a long-term cardiovascular outcomes trial. The prescribing information includes a recommendation to consider discontinuing treatment if patients develop signs to symptoms indicative of valvular heart disease and to evaluate patients for valvulopathy. Lorcaserin activates the serotonin 2C receptor, but at the approved dose of 10 mg twice a day, "does not appear to activate the serotonin 2B receptor," the FDA said in the June 27, 2012, approval announcement.

Weight-loss drugs fenfluramine and dexfenfluramine were taken off the market in 1997 after they were associated with valvular damage that was thought to be related to activation of the serotonin 2B receptor on cardiac tissue, according to the FDA.

Arena will be marketing lorcaserin as Belviq.

emechcatie@frontlinemedcom.com

Lorcaserin, a serotonin receptor agonist approved as a weight loss agent in 2012, has been scheduled as a schedule IV drug and is expected to be available within weeks, according to the manufacturer, Arena Pharmaceuticals.

The Drug Enforcement Administration (DEA) has placed lorcaserin (Belviq) in the schedule IV category of the Controlled Substances Act, which is for drugs with "a low potential for abuse and low risk of dependence." Other schedule IV drugs are alprazolam (Xanax), diazepam (Valium), and zolpidem (Ambien). Lorcaserin will be available 30 days after the final rule on the scheduling is published in the May 8th Federal Register, according to a May 7 statement issued by Arena.

The final rule in the Federal Register says that, on the basis of a review of the available data, the DEA determined that lorcaserin has a low potential for abuse relative to schedule III drugs, such as ketamine, and that the overall abuse potential of lorcaserin is comparable to schedule IV drugs, such a zolpidem. "Abuse of lorcaserin may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III. This finding is based on the ability of lorcaserin to produce positive subjective effects at supratherapeutic doses," according to the final rule.

After two FDA advisory panel meetings, the FDA approved lorcaserin in June 2012 as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of at least 30 kg/m² (obese), or at least 27 kg/m² (overweight) with at least one weight-related comorbid condition. The drug could not be marketed until the DEA finalized its decision regarding scheduling.

Because of concerns regarding the potential for valvulopathy associated with treatment, the company’s postmarketing commitments include conducting six studies, including a long-term cardiovascular outcomes trial. The prescribing information includes a recommendation to consider discontinuing treatment if patients develop signs to symptoms indicative of valvular heart disease and to evaluate patients for valvulopathy. Lorcaserin activates the serotonin 2C receptor, but at the approved dose of 10 mg twice a day, "does not appear to activate the serotonin 2B receptor," the FDA said in the June 27, 2012, approval announcement.

Weight-loss drugs fenfluramine and dexfenfluramine were taken off the market in 1997 after they were associated with valvular damage that was thought to be related to activation of the serotonin 2B receptor on cardiac tissue, according to the FDA.

Arena will be marketing lorcaserin as Belviq.

emechcatie@frontlinemedcom.com

ROME – Otherwise healthy, older men with a heart rate of 79 beats per minute or higher had a roughly 50% increased risk of developing heart failure, compared with men with slower heart rates, in a population-based cohort of more than 1,800 Dutch men.

The finding suggests that heart rate, independent of any other cardiovascular risk factor, could boost the risk for developing heart failure, and raises the possibility of trying to dampen this effect by using interventions to reduce heart rate, Dr. David Nanchen said at the annual meeting of the * European Association for Cardiovascular Prevention and Rehabilitation.

Mitchel L. Zoler/IMNG Medical Media

But the apparent link between resting heart rate and a boosted incidence of heart failure during follow-up occurred only in men. The analysis also included 2,939 women, who showed no suggestion of an association between baseline heart rate and subsequent development of heart failure.

The work reported by Dr. Nanchen also included an analysis that censored men who had an incident myocardial infarction during a median follow-up of 15 years, thereby eliminating cases of heart failure that occurred following an MI. In this analysis, men with a baseline heart rate of 79 beats per minute or greater had a statistically significant, 56% increased incidence of heart failure compared with men with an entry heart rate of less than 69 beats per minute, said Dr. Nanchen, head of the cardiovascular preventative clinic of the University of Lausanne (Switzerland).

Ruling out MI as a mediator between high heart rate and the development of heart failure means some other pathologic sequence is involved. One possibility is that patients with high heart rates develop tachycardia-induced cardiomyopathy that progresses to heart failure, Dr. Nanchen said in an interview."

His study included 4,768 people aged 55 or older enrolled in the Rotterdam Study from among apparently healthy people living in the Rotterdam area. During a median follow-up of 15 years, 656 enrollees developed heart failure. The analysis excluded people who at baseline had heart failure, coronary heart disease, atrial fibrillation, atrioventricular block, or a pacemaker, or were taking a beta-blocker or calcium channel blocker.

Among the 1,829 men in the study, every increment of 10 beats per minute in resting heart rate at entry into the study was linked with a statistically significant, 16% relative increase in the incidence of heart failure, an association not seen in women. When the researchers divided the men into tertiles based on their baseline heart rate, those in the top tertile with a rate of 79 beats per minute or greater had a 51% increased incidence of heart failure during follow-up, compared with men in the lowest tertile, with a rate of less than 69 beats per minute.

The analysis adjusted for age, smoking status, systolic blood pressure, diabetes, body mass index, total cholesterol level, HDL cholesterol level, and antihypertensive treatment.

The absence of this heart rate and heart failure link in women was a "surprise," Dr. Nanchen said. It’s possible that women’s hearts are more resilient to high heart rates, he suggested.

For the time being, the only intervention to offer otherwise healthy men older than 55 with a high heart rate is intensified control of lifestyle risk factors. Trial results showed that treatment with the heart rate–lowering drug ivabradine (Prooralan) in heart failure patients led to a reduction in heart failure–related hospitalizations (Lancet 2010;376:875-85).That experience makes it attractive to speculate that ivabradine treatment might also improve outcomes in men with high heart rates and no heart failure, but Dr. Nanchen said he had no immediate plans to test that hypothesis.

U.S. physicians won’t get the chance to study ivabradine in clinical practice for some time. Its manufacturer, Servier, has not disclosed any plans to submit a new drug application to the Food and Drug Administration.

Dr. Nanchen said he had no relevant financial disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction (5/29/13): A previous version of this story misstated the name of the meeting from which this presentation was made. This version has been updated.

ROME – Otherwise healthy, older men with a heart rate of 79 beats per minute or higher had a roughly 50% increased risk of developing heart failure, compared with men with slower heart rates, in a population-based cohort of more than 1,800 Dutch men.

The finding suggests that heart rate, independent of any other cardiovascular risk factor, could boost the risk for developing heart failure, and raises the possibility of trying to dampen this effect by using interventions to reduce heart rate, Dr. David Nanchen said at the annual meeting of the * European Association for Cardiovascular Prevention and Rehabilitation.

Mitchel L. Zoler/IMNG Medical Media

But the apparent link between resting heart rate and a boosted incidence of heart failure during follow-up occurred only in men. The analysis also included 2,939 women, who showed no suggestion of an association between baseline heart rate and subsequent development of heart failure.

The work reported by Dr. Nanchen also included an analysis that censored men who had an incident myocardial infarction during a median follow-up of 15 years, thereby eliminating cases of heart failure that occurred following an MI. In this analysis, men with a baseline heart rate of 79 beats per minute or greater had a statistically significant, 56% increased incidence of heart failure compared with men with an entry heart rate of less than 69 beats per minute, said Dr. Nanchen, head of the cardiovascular preventative clinic of the University of Lausanne (Switzerland).

Ruling out MI as a mediator between high heart rate and the development of heart failure means some other pathologic sequence is involved. One possibility is that patients with high heart rates develop tachycardia-induced cardiomyopathy that progresses to heart failure, Dr. Nanchen said in an interview."

His study included 4,768 people aged 55 or older enrolled in the Rotterdam Study from among apparently healthy people living in the Rotterdam area. During a median follow-up of 15 years, 656 enrollees developed heart failure. The analysis excluded people who at baseline had heart failure, coronary heart disease, atrial fibrillation, atrioventricular block, or a pacemaker, or were taking a beta-blocker or calcium channel blocker.

Among the 1,829 men in the study, every increment of 10 beats per minute in resting heart rate at entry into the study was linked with a statistically significant, 16% relative increase in the incidence of heart failure, an association not seen in women. When the researchers divided the men into tertiles based on their baseline heart rate, those in the top tertile with a rate of 79 beats per minute or greater had a 51% increased incidence of heart failure during follow-up, compared with men in the lowest tertile, with a rate of less than 69 beats per minute.

The analysis adjusted for age, smoking status, systolic blood pressure, diabetes, body mass index, total cholesterol level, HDL cholesterol level, and antihypertensive treatment.

The absence of this heart rate and heart failure link in women was a "surprise," Dr. Nanchen said. It’s possible that women’s hearts are more resilient to high heart rates, he suggested.

For the time being, the only intervention to offer otherwise healthy men older than 55 with a high heart rate is intensified control of lifestyle risk factors. Trial results showed that treatment with the heart rate–lowering drug ivabradine (Prooralan) in heart failure patients led to a reduction in heart failure–related hospitalizations (Lancet 2010;376:875-85).That experience makes it attractive to speculate that ivabradine treatment might also improve outcomes in men with high heart rates and no heart failure, but Dr. Nanchen said he had no immediate plans to test that hypothesis.

U.S. physicians won’t get the chance to study ivabradine in clinical practice for some time. Its manufacturer, Servier, has not disclosed any plans to submit a new drug application to the Food and Drug Administration.

Dr. Nanchen said he had no relevant financial disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction (5/29/13): A previous version of this story misstated the name of the meeting from which this presentation was made. This version has been updated.

ROME – Otherwise healthy, older men with a heart rate of 79 beats per minute or higher had a roughly 50% increased risk of developing heart failure, compared with men with slower heart rates, in a population-based cohort of more than 1,800 Dutch men.

The finding suggests that heart rate, independent of any other cardiovascular risk factor, could boost the risk for developing heart failure, and raises the possibility of trying to dampen this effect by using interventions to reduce heart rate, Dr. David Nanchen said at the annual meeting of the * European Association for Cardiovascular Prevention and Rehabilitation.

Mitchel L. Zoler/IMNG Medical Media

But the apparent link between resting heart rate and a boosted incidence of heart failure during follow-up occurred only in men. The analysis also included 2,939 women, who showed no suggestion of an association between baseline heart rate and subsequent development of heart failure.

The work reported by Dr. Nanchen also included an analysis that censored men who had an incident myocardial infarction during a median follow-up of 15 years, thereby eliminating cases of heart failure that occurred following an MI. In this analysis, men with a baseline heart rate of 79 beats per minute or greater had a statistically significant, 56% increased incidence of heart failure compared with men with an entry heart rate of less than 69 beats per minute, said Dr. Nanchen, head of the cardiovascular preventative clinic of the University of Lausanne (Switzerland).

Ruling out MI as a mediator between high heart rate and the development of heart failure means some other pathologic sequence is involved. One possibility is that patients with high heart rates develop tachycardia-induced cardiomyopathy that progresses to heart failure, Dr. Nanchen said in an interview."

His study included 4,768 people aged 55 or older enrolled in the Rotterdam Study from among apparently healthy people living in the Rotterdam area. During a median follow-up of 15 years, 656 enrollees developed heart failure. The analysis excluded people who at baseline had heart failure, coronary heart disease, atrial fibrillation, atrioventricular block, or a pacemaker, or were taking a beta-blocker or calcium channel blocker.

Among the 1,829 men in the study, every increment of 10 beats per minute in resting heart rate at entry into the study was linked with a statistically significant, 16% relative increase in the incidence of heart failure, an association not seen in women. When the researchers divided the men into tertiles based on their baseline heart rate, those in the top tertile with a rate of 79 beats per minute or greater had a 51% increased incidence of heart failure during follow-up, compared with men in the lowest tertile, with a rate of less than 69 beats per minute.

The analysis adjusted for age, smoking status, systolic blood pressure, diabetes, body mass index, total cholesterol level, HDL cholesterol level, and antihypertensive treatment.

The absence of this heart rate and heart failure link in women was a "surprise," Dr. Nanchen said. It’s possible that women’s hearts are more resilient to high heart rates, he suggested.

For the time being, the only intervention to offer otherwise healthy men older than 55 with a high heart rate is intensified control of lifestyle risk factors. Trial results showed that treatment with the heart rate–lowering drug ivabradine (Prooralan) in heart failure patients led to a reduction in heart failure–related hospitalizations (Lancet 2010;376:875-85).That experience makes it attractive to speculate that ivabradine treatment might also improve outcomes in men with high heart rates and no heart failure, but Dr. Nanchen said he had no immediate plans to test that hypothesis.

U.S. physicians won’t get the chance to study ivabradine in clinical practice for some time. Its manufacturer, Servier, has not disclosed any plans to submit a new drug application to the Food and Drug Administration.

Dr. Nanchen said he had no relevant financial disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction (5/29/13): A previous version of this story misstated the name of the meeting from which this presentation was made. This version has been updated.

WASHINGTON – The American Medical Association says that it is going to spend millions of dollars over the next 5 years to help physicians and patients do a better job of preventing and managing cardiovascular disease and diabetes.

AMA President Jeremy Lazarus announced the initiative at the National Minority Quality Forum’s Health Disparities Leadership Summit here, in part, because the two conditions disproportionately affect minorities. They have a significant impact on American life. Dr. Lazarus noted that 100 million Americans have prediabetes or diabetes – that’s one-third of the U.S. population. One of every three deaths is caused by cardiovascular disease. The cost of treating diabetes and CVD runs at least $500 billion a year, said Dr. Lazarus.

"The AMA will dedicate resources, expertise and reach to reduce the significant patient suffering and cost burdens associated with these diseases," said Dr. Lazarus.

Initially, the program will focus on helping physicians and patients focus on three risk factors for CVD and diabetes: hypertension, blood glucose, and lipids. The AMA plans to spend $6 million on the initiative in the first year alone, said Dr. Lazarus, in an interview.

The AMA will continue to evaluate the program as it goes along, possibly tweaking the goals, and eventually adding other conditions, said Dr. Lazarus. And, for physicians who participate, there may be another benefit: financial rewards for putting patients on the path to better health. Dr. Lazarus noted that many accountable care organizations and insurers were providing incentives for preventing and managing chronic conditions. "The health care system is moving in this direction," he said.

In hypertension, the AMA seeks to meet or exceed the goal of the Dept. of Health and Human Services’ Million Hearts campaign. That program aims to bring 10 million more Americans under control by 2017. To do that, the AMA has enlisted the Armstrong Institute for Patient Safety and Quality at the Johns Hopkins School of Medicine. The Armstrong Institute, directed by Dr. Peter J. Pronovost, is best known for creating a program to reduce central line-associated bloodstream infections in intensive care units.

The Institute will be sending people out to meet with physicians to figure out what factors in their patient population contributes to high blood pressure, said Dr. Lazarus, in the interview. That information, in conjunction with evidence-based interventions, will be used to help physicians determine how to best help their patients. "We think [physicians] will welcome the opportunity to work with the Armstrong Institute," Dr. Lazarus said.

For diabetes, the AMA is working with the YMCA to increase referrals to the evidence-based prevention program offered by the organization. The AMA wants to have 10,000 additional participants in the program by July 2015.

"Connecting physician practices to the YMCA’s Diabetes Prevention Program will ensure that those at greatest risk have the opportunity to prevent or delay diabetes," said Jonathan Lever, vice president of health innovation and strategy, YMCA of the USA, in a statement. "This novel collaboration between medical practices and community-based programs could prove to be a model for promoting health and wellness."

At the disparities meeting, Dr. Cedric Bright, director of special programs at the University of North Carolina, Chapel Hill, said that YMCA’s are not always in communities of color, and he suggested that the AMA also work with Boys and Girls Clubs. Dr. Lazarus agreed, and said, "We’re going to be looking for all kinds of partners to get the information out."

Dr. Rodney Hood, president of the Multicultural Primary Care Medical Group, an independent practice association in San Diego said he congratulated the AMA for starting the initiative. "Dr. Lazarus, I think this is a big deal," said Dr. Hood.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – The American Medical Association says that it is going to spend millions of dollars over the next 5 years to help physicians and patients do a better job of preventing and managing cardiovascular disease and diabetes.

AMA President Jeremy Lazarus announced the initiative at the National Minority Quality Forum’s Health Disparities Leadership Summit here, in part, because the two conditions disproportionately affect minorities. They have a significant impact on American life. Dr. Lazarus noted that 100 million Americans have prediabetes or diabetes – that’s one-third of the U.S. population. One of every three deaths is caused by cardiovascular disease. The cost of treating diabetes and CVD runs at least $500 billion a year, said Dr. Lazarus.

"The AMA will dedicate resources, expertise and reach to reduce the significant patient suffering and cost burdens associated with these diseases," said Dr. Lazarus.

Initially, the program will focus on helping physicians and patients focus on three risk factors for CVD and diabetes: hypertension, blood glucose, and lipids. The AMA plans to spend $6 million on the initiative in the first year alone, said Dr. Lazarus, in an interview.

The AMA will continue to evaluate the program as it goes along, possibly tweaking the goals, and eventually adding other conditions, said Dr. Lazarus. And, for physicians who participate, there may be another benefit: financial rewards for putting patients on the path to better health. Dr. Lazarus noted that many accountable care organizations and insurers were providing incentives for preventing and managing chronic conditions. "The health care system is moving in this direction," he said.

In hypertension, the AMA seeks to meet or exceed the goal of the Dept. of Health and Human Services’ Million Hearts campaign. That program aims to bring 10 million more Americans under control by 2017. To do that, the AMA has enlisted the Armstrong Institute for Patient Safety and Quality at the Johns Hopkins School of Medicine. The Armstrong Institute, directed by Dr. Peter J. Pronovost, is best known for creating a program to reduce central line-associated bloodstream infections in intensive care units.

The Institute will be sending people out to meet with physicians to figure out what factors in their patient population contributes to high blood pressure, said Dr. Lazarus, in the interview. That information, in conjunction with evidence-based interventions, will be used to help physicians determine how to best help their patients. "We think [physicians] will welcome the opportunity to work with the Armstrong Institute," Dr. Lazarus said.

For diabetes, the AMA is working with the YMCA to increase referrals to the evidence-based prevention program offered by the organization. The AMA wants to have 10,000 additional participants in the program by July 2015.

"Connecting physician practices to the YMCA’s Diabetes Prevention Program will ensure that those at greatest risk have the opportunity to prevent or delay diabetes," said Jonathan Lever, vice president of health innovation and strategy, YMCA of the USA, in a statement. "This novel collaboration between medical practices and community-based programs could prove to be a model for promoting health and wellness."

At the disparities meeting, Dr. Cedric Bright, director of special programs at the University of North Carolina, Chapel Hill, said that YMCA’s are not always in communities of color, and he suggested that the AMA also work with Boys and Girls Clubs. Dr. Lazarus agreed, and said, "We’re going to be looking for all kinds of partners to get the information out."

Dr. Rodney Hood, president of the Multicultural Primary Care Medical Group, an independent practice association in San Diego said he congratulated the AMA for starting the initiative. "Dr. Lazarus, I think this is a big deal," said Dr. Hood.

aault@frontlinemedcom.com

On Twitter @aliciaault

WASHINGTON – The American Medical Association says that it is going to spend millions of dollars over the next 5 years to help physicians and patients do a better job of preventing and managing cardiovascular disease and diabetes.

AMA President Jeremy Lazarus announced the initiative at the National Minority Quality Forum’s Health Disparities Leadership Summit here, in part, because the two conditions disproportionately affect minorities. They have a significant impact on American life. Dr. Lazarus noted that 100 million Americans have prediabetes or diabetes – that’s one-third of the U.S. population. One of every three deaths is caused by cardiovascular disease. The cost of treating diabetes and CVD runs at least $500 billion a year, said Dr. Lazarus.

"The AMA will dedicate resources, expertise and reach to reduce the significant patient suffering and cost burdens associated with these diseases," said Dr. Lazarus.

Initially, the program will focus on helping physicians and patients focus on three risk factors for CVD and diabetes: hypertension, blood glucose, and lipids. The AMA plans to spend $6 million on the initiative in the first year alone, said Dr. Lazarus, in an interview.

The AMA will continue to evaluate the program as it goes along, possibly tweaking the goals, and eventually adding other conditions, said Dr. Lazarus. And, for physicians who participate, there may be another benefit: financial rewards for putting patients on the path to better health. Dr. Lazarus noted that many accountable care organizations and insurers were providing incentives for preventing and managing chronic conditions. "The health care system is moving in this direction," he said.

In hypertension, the AMA seeks to meet or exceed the goal of the Dept. of Health and Human Services’ Million Hearts campaign. That program aims to bring 10 million more Americans under control by 2017. To do that, the AMA has enlisted the Armstrong Institute for Patient Safety and Quality at the Johns Hopkins School of Medicine. The Armstrong Institute, directed by Dr. Peter J. Pronovost, is best known for creating a program to reduce central line-associated bloodstream infections in intensive care units.

The Institute will be sending people out to meet with physicians to figure out what factors in their patient population contributes to high blood pressure, said Dr. Lazarus, in the interview. That information, in conjunction with evidence-based interventions, will be used to help physicians determine how to best help their patients. "We think [physicians] will welcome the opportunity to work with the Armstrong Institute," Dr. Lazarus said.

For diabetes, the AMA is working with the YMCA to increase referrals to the evidence-based prevention program offered by the organization. The AMA wants to have 10,000 additional participants in the program by July 2015.

"Connecting physician practices to the YMCA’s Diabetes Prevention Program will ensure that those at greatest risk have the opportunity to prevent or delay diabetes," said Jonathan Lever, vice president of health innovation and strategy, YMCA of the USA, in a statement. "This novel collaboration between medical practices and community-based programs could prove to be a model for promoting health and wellness."

At the disparities meeting, Dr. Cedric Bright, director of special programs at the University of North Carolina, Chapel Hill, said that YMCA’s are not always in communities of color, and he suggested that the AMA also work with Boys and Girls Clubs. Dr. Lazarus agreed, and said, "We’re going to be looking for all kinds of partners to get the information out."

Dr. Rodney Hood, president of the Multicultural Primary Care Medical Group, an independent practice association in San Diego said he congratulated the AMA for starting the initiative. "Dr. Lazarus, I think this is a big deal," said Dr. Hood.

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO – Clinically important medication errors occurred in 51% of patients within 3 months of discharge from hospitalization for acute coronary syndrome and/or decompensated heart failure, a study of 851 patients showed.

In addition, the randomized controlled trial found no benefit from a predischarge pharmacist intervention and counseling incorporating tools designed for patients with low health literacy levels, compared with usual care in which the treating health care provider reconciled medications with the help of support software before patient discharge.

Although the trial focused on comparing the pharmacist intervention with usual care, "the biggest take-home message is that medication errors are very common" in these patients after hospitalization, Dr. Cecelia N. Theobald said at the annual meeting of the American College of Physicians.

Patients came from Vanderbilt University Medical Center in Nashville, Tenn., and from Brigham and Women’s Hospital in Boston. The study randomized 423 patients to the intervention and 428 to usual care.

In the intervention group, pharmacists reconciled medications and provided in-depth patient counseling before discharge, including a review of potential drug side effects. The pharmacists had specialized aids to help low-literacy patients adhere to their medication regimens, and they provided tailored follow-up to patients via postdischarge phone calls. In the usual-care group, the treating provider reconciled medications and pharmacist consultation was available on request. The usual-care group did not use the low-literacy aids or phone follow-up.

To assess outcomes, two clinicians reviewed patient records and patients were interviewed by phone 30 days after discharge.

Thirty percent of patients had one or more adverse drug events that were considered to be preventable or ameliorable. Another 30% of patients had at least one potential adverse drug event, she said. Adverse drug events occurred in 47% of patients on cardiovascular agents other than diuretics, 21% of patients on diuretics, and 5% of patients on opioids. Potential adverse drug events were seen in 43% of patients on cardiovascular agents other than diuretics, and in 12% of patients on diuretics (Ann. Intern. Med. 2012;157:1-10).

On a per-patient basis, 0.87 clinically important medication errors occurred in the intervention group, compared with 0.95 events per patient in the usual-care group, a difference that was not statistically significant, reported Dr. Theobald of Vanderbilt University and her associates.

These events included adverse drug events (0.43 per patient in the intervention group and 0.40 per patient in the control group) and potential adverse drug events (0.44 per patient in the intervention group and 0.55 in the control group), rates of which did not differ significantly between groups.

"If we can’t figure out a way to talk to our patients immediately after discharge, these problems will continue," one physician in the audience said during the discussion session after the presentation.

Dr. Theobald noted that the Vanderbilt University system still has pharmacists available to counsel patients before discharge, but only at the request of clinicians, not routinely.

At the start of the study, 41% in the intervention group and 42% in the control group were female, and 61% in both groups had acute coronary syndrome. Congestive heart failure was diagnosed in 32% of the intervention group and 31% of the control group, and both diagnoses were present in 7% of the intervention group and 8% of the control group. Before admission, patients in the intervention group were on a median of eight medications, and those in the control group were taking a median of seven medications.

Health literacy levels were considered marginal in 9% of each group, and inadequate in 12% of the intervention group and 9% of the control group. Twelve percent of patients in the intervention group and 11% of patients in the control group had cognitive impairment.

There were suggestions of benefit from the intervention, compared with usual care, in three prespecified subgroups, but these did not reach statistical significance. With the intervention, clinically important medication errors were 32% less likely in patients with inadequate health literacy, 38% less likely in cognitively impaired patients, and 17% less likely in patients treated at Vanderbilt.

Further work would be needed to determine if high-risk subgroups should be targeted for this kind of intervention, Dr. Theobald said.

In general, 13%-17% of patients develop clinically important medication errors after hospitalization, according to previous studies. An estimated 50%-75% of those errors are preventable or ameliorable, other data suggest. Some studies report that postdischarge medication errors may be more common in patients who are older, are on complex regimens of multiple medications, are cognitively impaired, or have low health literacy. Previous trials of interventions to reduce posthospitalization medication errors have produced mixed results.

The National Heart, Lung, and Blood Institute and the Department of Veterans Affairs funded the study. Dr. Theobald reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Clinically important medication errors occurred in 51% of patients within 3 months of discharge from hospitalization for acute coronary syndrome and/or decompensated heart failure, a study of 851 patients showed.

In addition, the randomized controlled trial found no benefit from a predischarge pharmacist intervention and counseling incorporating tools designed for patients with low health literacy levels, compared with usual care in which the treating health care provider reconciled medications with the help of support software before patient discharge.

Although the trial focused on comparing the pharmacist intervention with usual care, "the biggest take-home message is that medication errors are very common" in these patients after hospitalization, Dr. Cecelia N. Theobald said at the annual meeting of the American College of Physicians.

Patients came from Vanderbilt University Medical Center in Nashville, Tenn., and from Brigham and Women’s Hospital in Boston. The study randomized 423 patients to the intervention and 428 to usual care.

In the intervention group, pharmacists reconciled medications and provided in-depth patient counseling before discharge, including a review of potential drug side effects. The pharmacists had specialized aids to help low-literacy patients adhere to their medication regimens, and they provided tailored follow-up to patients via postdischarge phone calls. In the usual-care group, the treating provider reconciled medications and pharmacist consultation was available on request. The usual-care group did not use the low-literacy aids or phone follow-up.

To assess outcomes, two clinicians reviewed patient records and patients were interviewed by phone 30 days after discharge.

Thirty percent of patients had one or more adverse drug events that were considered to be preventable or ameliorable. Another 30% of patients had at least one potential adverse drug event, she said. Adverse drug events occurred in 47% of patients on cardiovascular agents other than diuretics, 21% of patients on diuretics, and 5% of patients on opioids. Potential adverse drug events were seen in 43% of patients on cardiovascular agents other than diuretics, and in 12% of patients on diuretics (Ann. Intern. Med. 2012;157:1-10).

On a per-patient basis, 0.87 clinically important medication errors occurred in the intervention group, compared with 0.95 events per patient in the usual-care group, a difference that was not statistically significant, reported Dr. Theobald of Vanderbilt University and her associates.

These events included adverse drug events (0.43 per patient in the intervention group and 0.40 per patient in the control group) and potential adverse drug events (0.44 per patient in the intervention group and 0.55 in the control group), rates of which did not differ significantly between groups.

"If we can’t figure out a way to talk to our patients immediately after discharge, these problems will continue," one physician in the audience said during the discussion session after the presentation.

Dr. Theobald noted that the Vanderbilt University system still has pharmacists available to counsel patients before discharge, but only at the request of clinicians, not routinely.

At the start of the study, 41% in the intervention group and 42% in the control group were female, and 61% in both groups had acute coronary syndrome. Congestive heart failure was diagnosed in 32% of the intervention group and 31% of the control group, and both diagnoses were present in 7% of the intervention group and 8% of the control group. Before admission, patients in the intervention group were on a median of eight medications, and those in the control group were taking a median of seven medications.

Health literacy levels were considered marginal in 9% of each group, and inadequate in 12% of the intervention group and 9% of the control group. Twelve percent of patients in the intervention group and 11% of patients in the control group had cognitive impairment.

There were suggestions of benefit from the intervention, compared with usual care, in three prespecified subgroups, but these did not reach statistical significance. With the intervention, clinically important medication errors were 32% less likely in patients with inadequate health literacy, 38% less likely in cognitively impaired patients, and 17% less likely in patients treated at Vanderbilt.

Further work would be needed to determine if high-risk subgroups should be targeted for this kind of intervention, Dr. Theobald said.

In general, 13%-17% of patients develop clinically important medication errors after hospitalization, according to previous studies. An estimated 50%-75% of those errors are preventable or ameliorable, other data suggest. Some studies report that postdischarge medication errors may be more common in patients who are older, are on complex regimens of multiple medications, are cognitively impaired, or have low health literacy. Previous trials of interventions to reduce posthospitalization medication errors have produced mixed results.

The National Heart, Lung, and Blood Institute and the Department of Veterans Affairs funded the study. Dr. Theobald reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Clinically important medication errors occurred in 51% of patients within 3 months of discharge from hospitalization for acute coronary syndrome and/or decompensated heart failure, a study of 851 patients showed.

In addition, the randomized controlled trial found no benefit from a predischarge pharmacist intervention and counseling incorporating tools designed for patients with low health literacy levels, compared with usual care in which the treating health care provider reconciled medications with the help of support software before patient discharge.

Although the trial focused on comparing the pharmacist intervention with usual care, "the biggest take-home message is that medication errors are very common" in these patients after hospitalization, Dr. Cecelia N. Theobald said at the annual meeting of the American College of Physicians.

Patients came from Vanderbilt University Medical Center in Nashville, Tenn., and from Brigham and Women’s Hospital in Boston. The study randomized 423 patients to the intervention and 428 to usual care.

In the intervention group, pharmacists reconciled medications and provided in-depth patient counseling before discharge, including a review of potential drug side effects. The pharmacists had specialized aids to help low-literacy patients adhere to their medication regimens, and they provided tailored follow-up to patients via postdischarge phone calls. In the usual-care group, the treating provider reconciled medications and pharmacist consultation was available on request. The usual-care group did not use the low-literacy aids or phone follow-up.

To assess outcomes, two clinicians reviewed patient records and patients were interviewed by phone 30 days after discharge.

Thirty percent of patients had one or more adverse drug events that were considered to be preventable or ameliorable. Another 30% of patients had at least one potential adverse drug event, she said. Adverse drug events occurred in 47% of patients on cardiovascular agents other than diuretics, 21% of patients on diuretics, and 5% of patients on opioids. Potential adverse drug events were seen in 43% of patients on cardiovascular agents other than diuretics, and in 12% of patients on diuretics (Ann. Intern. Med. 2012;157:1-10).

On a per-patient basis, 0.87 clinically important medication errors occurred in the intervention group, compared with 0.95 events per patient in the usual-care group, a difference that was not statistically significant, reported Dr. Theobald of Vanderbilt University and her associates.

These events included adverse drug events (0.43 per patient in the intervention group and 0.40 per patient in the control group) and potential adverse drug events (0.44 per patient in the intervention group and 0.55 in the control group), rates of which did not differ significantly between groups.

"If we can’t figure out a way to talk to our patients immediately after discharge, these problems will continue," one physician in the audience said during the discussion session after the presentation.

Dr. Theobald noted that the Vanderbilt University system still has pharmacists available to counsel patients before discharge, but only at the request of clinicians, not routinely.

At the start of the study, 41% in the intervention group and 42% in the control group were female, and 61% in both groups had acute coronary syndrome. Congestive heart failure was diagnosed in 32% of the intervention group and 31% of the control group, and both diagnoses were present in 7% of the intervention group and 8% of the control group. Before admission, patients in the intervention group were on a median of eight medications, and those in the control group were taking a median of seven medications.

Health literacy levels were considered marginal in 9% of each group, and inadequate in 12% of the intervention group and 9% of the control group. Twelve percent of patients in the intervention group and 11% of patients in the control group had cognitive impairment.

There were suggestions of benefit from the intervention, compared with usual care, in three prespecified subgroups, but these did not reach statistical significance. With the intervention, clinically important medication errors were 32% less likely in patients with inadequate health literacy, 38% less likely in cognitively impaired patients, and 17% less likely in patients treated at Vanderbilt.

Further work would be needed to determine if high-risk subgroups should be targeted for this kind of intervention, Dr. Theobald said.

In general, 13%-17% of patients develop clinically important medication errors after hospitalization, according to previous studies. An estimated 50%-75% of those errors are preventable or ameliorable, other data suggest. Some studies report that postdischarge medication errors may be more common in patients who are older, are on complex regimens of multiple medications, are cognitively impaired, or have low health literacy. Previous trials of interventions to reduce posthospitalization medication errors have produced mixed results.

The National Heart, Lung, and Blood Institute and the Department of Veterans Affairs funded the study. Dr. Theobald reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

Biventricular pacing is superior to conventional right ventricular pacing in patients who have atrioventricular block and left ventricular systolic dysfunction with mild to moderate heart failure, according to a study that was presented at the American Heart Association meeting last November and has now been published online April 24 in the New England Journal of Medicine.

In the industry-sponsored prospective randomized clinical trial, 691 patients at 58 medical centers in the United States and Canada were randomly assigned to receive right ventricular or biventricular pacing using a pacemaker or implantable cardioverter defibrillator (ICD), during an 8-year period, said Dr. Anne B. Curtis, professor and chair of the department of medicine at the University of Buffalo (N.Y.), and her associates.

After a mean follow-up of 37 months, the primary outcome – a composite of death from any cause, an urgent care visit for HF, or an increase of 15% or more in LV end-systolic volume index – occurred in 53.3% of the biventricular group, which was significantly lower than the 64.3% rate in the right ventricular group. This benefit was seen both in patients given a pacemaker and in those given an ICD, with the two devices exerting "a remarkably similar clinical effect" even though there was a marked difference in mean ejection fraction between pacemaker recipients and ICD recipients. This suggests that the benefit of biventricular pacing is not likely to be strongly related to EF, the investigators said (N. Engl. J. Med. 2013 April 24 [doi:10.1056/NEJMoa1210356]).

At the AHA meeting, study discussant Dr. Gerasimos S. Filippatos of the University of Athens said that the BLOCK-HF results would certainly lead to a reconsideration of current European Society of Cardiology and joint American College of Cardiology/AHA/Heart Rhythm Society guidelines for heart failure patients with heart block.

The authors noted that BLOCK-HF adds to the body of evidence suggesting that biventricular pacing in patients with AV block preserves systolic function." Dr. Curtis said while presenting the results in November that one of the key points of BLOCK-HF "was to look at whether or not putting patients through the added difficulty of implanting a biventricular pacing device has clear benefits – and the answer is yes."

This study was funded by Medtronic, which also provided the data collection and analysis. Dr. Curtis and her associates reported numerous ties to industry sources.

Biventricular pacing is superior to conventional right ventricular pacing in patients who have atrioventricular block and left ventricular systolic dysfunction with mild to moderate heart failure, according to a study that was presented at the American Heart Association meeting last November and has now been published online April 24 in the New England Journal of Medicine.

In the industry-sponsored prospective randomized clinical trial, 691 patients at 58 medical centers in the United States and Canada were randomly assigned to receive right ventricular or biventricular pacing using a pacemaker or implantable cardioverter defibrillator (ICD), during an 8-year period, said Dr. Anne B. Curtis, professor and chair of the department of medicine at the University of Buffalo (N.Y.), and her associates.

After a mean follow-up of 37 months, the primary outcome – a composite of death from any cause, an urgent care visit for HF, or an increase of 15% or more in LV end-systolic volume index – occurred in 53.3% of the biventricular group, which was significantly lower than the 64.3% rate in the right ventricular group. This benefit was seen both in patients given a pacemaker and in those given an ICD, with the two devices exerting "a remarkably similar clinical effect" even though there was a marked difference in mean ejection fraction between pacemaker recipients and ICD recipients. This suggests that the benefit of biventricular pacing is not likely to be strongly related to EF, the investigators said (N. Engl. J. Med. 2013 April 24 [doi:10.1056/NEJMoa1210356]).

At the AHA meeting, study discussant Dr. Gerasimos S. Filippatos of the University of Athens said that the BLOCK-HF results would certainly lead to a reconsideration of current European Society of Cardiology and joint American College of Cardiology/AHA/Heart Rhythm Society guidelines for heart failure patients with heart block.

The authors noted that BLOCK-HF adds to the body of evidence suggesting that biventricular pacing in patients with AV block preserves systolic function." Dr. Curtis said while presenting the results in November that one of the key points of BLOCK-HF "was to look at whether or not putting patients through the added difficulty of implanting a biventricular pacing device has clear benefits – and the answer is yes."

This study was funded by Medtronic, which also provided the data collection and analysis. Dr. Curtis and her associates reported numerous ties to industry sources.

Biventricular pacing is superior to conventional right ventricular pacing in patients who have atrioventricular block and left ventricular systolic dysfunction with mild to moderate heart failure, according to a study that was presented at the American Heart Association meeting last November and has now been published online April 24 in the New England Journal of Medicine.

In the industry-sponsored prospective randomized clinical trial, 691 patients at 58 medical centers in the United States and Canada were randomly assigned to receive right ventricular or biventricular pacing using a pacemaker or implantable cardioverter defibrillator (ICD), during an 8-year period, said Dr. Anne B. Curtis, professor and chair of the department of medicine at the University of Buffalo (N.Y.), and her associates.

After a mean follow-up of 37 months, the primary outcome – a composite of death from any cause, an urgent care visit for HF, or an increase of 15% or more in LV end-systolic volume index – occurred in 53.3% of the biventricular group, which was significantly lower than the 64.3% rate in the right ventricular group. This benefit was seen both in patients given a pacemaker and in those given an ICD, with the two devices exerting "a remarkably similar clinical effect" even though there was a marked difference in mean ejection fraction between pacemaker recipients and ICD recipients. This suggests that the benefit of biventricular pacing is not likely to be strongly related to EF, the investigators said (N. Engl. J. Med. 2013 April 24 [doi:10.1056/NEJMoa1210356]).

At the AHA meeting, study discussant Dr. Gerasimos S. Filippatos of the University of Athens said that the BLOCK-HF results would certainly lead to a reconsideration of current European Society of Cardiology and joint American College of Cardiology/AHA/Heart Rhythm Society guidelines for heart failure patients with heart block.

The authors noted that BLOCK-HF adds to the body of evidence suggesting that biventricular pacing in patients with AV block preserves systolic function." Dr. Curtis said while presenting the results in November that one of the key points of BLOCK-HF "was to look at whether or not putting patients through the added difficulty of implanting a biventricular pacing device has clear benefits – and the answer is yes."

This study was funded by Medtronic, which also provided the data collection and analysis. Dr. Curtis and her associates reported numerous ties to industry sources.