Mitchel L. Zoler, PhD

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the annual meeting of the American College of Cardiology.

"These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people," said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. "If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don’t think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important" determinant of declines in cognition and mobility and in an MRI measure of brain damage, "and blood pressure is something where we can intervene," he said.

"Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don’t think about the chronic burden on the brain," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer’s disease probably had poorly controlled hypertension over their lifetime."

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. "The people only averaged 144 mm Hg. That’s not so bad, but they had progression," Dr. White said.

He said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the annual meeting of the American College of Cardiology.

"These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people," said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. "If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don’t think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important" determinant of declines in cognition and mobility and in an MRI measure of brain damage, "and blood pressure is something where we can intervene," he said.

"Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don’t think about the chronic burden on the brain," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer’s disease probably had poorly controlled hypertension over their lifetime."

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. "The people only averaged 144 mm Hg. That’s not so bad, but they had progression," Dr. White said.

He said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the annual meeting of the American College of Cardiology.

"These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people," said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. "If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don’t think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important" determinant of declines in cognition and mobility and in an MRI measure of brain damage, "and blood pressure is something where we can intervene," he said.

"Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don’t think about the chronic burden on the brain," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer’s disease probably had poorly controlled hypertension over their lifetime."

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. "The people only averaged 144 mm Hg. That’s not so bad, but they had progression," Dr. White said.

He said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the annual meeting of the American College of Cardiology.

"These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people," said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. "If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don’t think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important" determinant of declines in cognition and mobility and in an MRI measure of brain damage, "and blood pressure is something where we can intervene," he said.

"Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don’t think about the chronic burden on the brain," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer’s disease probably had poorly controlled hypertension over their lifetime."

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. "The people only averaged 144 mm Hg. That’s not so bad, but they had progression," Dr. White said.

He said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the annual meeting of the American College of Cardiology.

"These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people," said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. "If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don’t think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important" determinant of declines in cognition and mobility and in an MRI measure of brain damage, "and blood pressure is something where we can intervene," he said.

"Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don’t think about the chronic burden on the brain," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer’s disease probably had poorly controlled hypertension over their lifetime."

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. "The people only averaged 144 mm Hg. That’s not so bad, but they had progression," Dr. White said.

He said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the annual meeting of the American College of Cardiology.

"These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people," said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. "If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don’t think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important" determinant of declines in cognition and mobility and in an MRI measure of brain damage, "and blood pressure is something where we can intervene," he said.

"Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don’t think about the chronic burden on the brain," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer’s disease probably had poorly controlled hypertension over their lifetime."

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. "The people only averaged 144 mm Hg. That’s not so bad, but they had progression," Dr. White said.

He said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the annual meeting of the American College of Cardiology.

"These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people," said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. "If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don’t think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important" determinant of declines in cognition and mobility and in an MRI measure of brain damage, "and blood pressure is something where we can intervene," he said.

"Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don’t think about the chronic burden on the brain," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer’s disease probably had poorly controlled hypertension over their lifetime."

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. "The people only averaged 144 mm Hg. That’s not so bad, but they had progression," Dr. White said.

He said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the annual meeting of the American College of Cardiology.

"These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people," said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. "If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don’t think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important" determinant of declines in cognition and mobility and in an MRI measure of brain damage, "and blood pressure is something where we can intervene," he said.

"Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don’t think about the chronic burden on the brain," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer’s disease probably had poorly controlled hypertension over their lifetime."

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. "The people only averaged 144 mm Hg. That’s not so bad, but they had progression," Dr. White said.

He said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the annual meeting of the American College of Cardiology.

"These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people," said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. "If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don’t think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important" determinant of declines in cognition and mobility and in an MRI measure of brain damage, "and blood pressure is something where we can intervene," he said.

"Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don’t think about the chronic burden on the brain," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer’s disease probably had poorly controlled hypertension over their lifetime."

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. "The people only averaged 144 mm Hg. That’s not so bad, but they had progression," Dr. White said.

He said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the annual meeting of the American College of Cardiology.

"Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic," said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. "Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before."

The stabilization regimen used by Dr. Schou and his associates involved uptitrating the drugs patients received so that their medical treatment used drugs such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study’s other eligibility criteria.

"The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner," he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C.Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, "BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP" repeatedly, he said in an interview.

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study’s prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker (ARB), beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study’s primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the annual meeting of the American College of Cardiology.

"Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic," said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. "Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before."

The stabilization regimen used by Dr. Schou and his associates involved uptitrating the drugs patients received so that their medical treatment used drugs such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study’s other eligibility criteria.

"The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner," he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C.Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, "BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP" repeatedly, he said in an interview.

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study’s prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker (ARB), beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study’s primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the annual meeting of the American College of Cardiology.

"Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic," said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. "Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before."

The stabilization regimen used by Dr. Schou and his associates involved uptitrating the drugs patients received so that their medical treatment used drugs such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study’s other eligibility criteria.

"The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner," he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C.Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, "BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP" repeatedly, he said in an interview.

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study’s prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker (ARB), beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study’s primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the annual meeting of the American College of Cardiology.

"Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic," said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. "Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before."

The stabilization regimen used by Dr. Schou and his associates involved uptitrating the drugs patients received so that their medical treatment used drugs such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study’s other eligibility criteria.

"The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner," he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C.Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, "BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP" repeatedly, he said in an interview.

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study’s prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker (ARB), beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study’s primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the annual meeting of the American College of Cardiology.

"Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic," said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. "Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before."

The stabilization regimen used by Dr. Schou and his associates involved uptitrating the drugs patients received so that their medical treatment used drugs such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study’s other eligibility criteria.

"The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner," he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C.Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, "BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP" repeatedly, he said in an interview.

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study’s prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker (ARB), beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study’s primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the annual meeting of the American College of Cardiology.

"Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic," said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. "Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before."

The stabilization regimen used by Dr. Schou and his associates involved uptitrating the drugs patients received so that their medical treatment used drugs such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study’s other eligibility criteria.

"The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner," he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C.Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, "BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP" repeatedly, he said in an interview.

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study’s prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker (ARB), beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study’s primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the annual meeting of the American College of Cardiology.

"Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic," said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. "Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before."

The stabilization regimen used by Dr. Schou and his associates involved uptitrating the drugs patients received so that their medical treatment used drugs such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study’s other eligibility criteria.

"The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner," he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C.Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, "BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP" repeatedly, he said in an interview.

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study’s prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker (ARB), beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study’s primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the annual meeting of the American College of Cardiology.

"Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic," said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. "Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before."

The stabilization regimen used by Dr. Schou and his associates involved uptitrating the drugs patients received so that their medical treatment used drugs such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study’s other eligibility criteria.

"The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner," he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C.Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, "BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP" repeatedly, he said in an interview.

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study’s prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker (ARB), beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study’s primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the annual meeting of the American College of Cardiology.

"Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic," said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. "Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before."

The stabilization regimen used by Dr. Schou and his associates involved uptitrating the drugs patients received so that their medical treatment used drugs such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study’s other eligibility criteria.

"The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner," he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C.Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, "BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP" repeatedly, he said in an interview.

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study’s prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker (ARB), beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study’s primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

LOS ANGELES - Women, as well as all patients aged 65 years or older who have substantial carotid artery stenosis that needs revascularization, may prefer endarterectomy, and would want to steer clear of carotid stenting, according to new data from CREST, the largest randomized trial to compare these two carotid interventions.

All patients aged 65 or older who were randomized to treatment by carotid artery stenting had a statistically significant excess of strokes, compared with similar subgroups who were treated with CEA during the periprocedural period and 4-year follow-up, George Howard, Dr.P.H., said at the conference. “Patient age should be an important factor in selecting the treatment option for carotid stenosis," said Dr. Howard, professor and chairman of biostatistics at the University of Alabama at Birmingham.

Analysis of the patients enrolled in CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial) by sex showed that the treatment of carotid stenosis by stenting led to an excess rate of periprocedural strokes among women, but not in men, Virginia J. Howard, Ph.D., said in a separate talk at the conference. Women who underwent an endarterectomy also had no excess risk for myocardial infarctions, compared with women who received a carotid stent, unlike men who had a significantly increased rate of MIs following open surgery, compared with those who got stented, said Dr. Howard, an epidemiologist at the University of Alabama at Birmingham.

The primary results from CREST, first reported last year, showed that all patients who were enrolled in the study had similar rates of stroke, MI, or death regardless of whether they underwent carotid CEA or stenting (N. Engl. J. Med. 2010;363:11-23).

But these new details, which show an excess rate of periprocedural strokes in women undergoing stenting as well as the excess of all strokes in patients aged 65 or older undergoing stenting, may tip the balance away from stenting in these patients.

Going into CREST, which began in 2000, “we thought the results would be the opposite. [At that time,] we preferred to take older patients to stenting," commented Dr. Thomas G. Brott, lead investigator for CREST and a professor of neurology and director or research at the Mayo Clinic in Jacksonville, Fla. “Our interventionalists believe that age is a surrogate marker for patients with calcified and tortuous vessels that might not be suitable for stenting." Regarding the sex-related finding, the implications “depend on how a woman would value [the risk of having] a stroke or a MI. If the woman is more concerned about a periprocedural stroke, then the results suggest there could be a preference for endarterectomy," Dr. Brott said in an interview.

In the sex-based analysis, the rate of periprocedural stroke was 5.5% in stented women and 2.2% in those who underwent CEA, a statistically significant 2.6-fold increased rate with stenting, Dr. Virginia Howard reported.

During the entire follow-up, which added the rate of ipsilateral strokes during 4 years following the intervention, stroke rates were 7.8% in stented women and 5.0% in those who had endarterectomy, a nonsignificant difference. The two treatment options produced no difference in stroke rates in men, either periprocedurally or after 4 years. MI rates were similar in women following either intervention, both periprocedurally and after 4 years. The periprocedural and 4-year MI rates in men were significantly higher with CEA.

In the age-based analyses, a calculation that used age as a continuous variable showed that the number of strokes occurring with either CEA or stenting was similar for patients aged 64 years. For those aged 65 or older, fewer strokes occurred with CEA, a relationship that grew stronger with increasing age. For patients aged 63 or younger, stenting produced fewer strokes, and the relationship grew stronger with decreasing age.

The age analysis also divided patients into three prespecified age groups: younger than 65, 65-74 years, and 75 and older. (See box.) The most striking age effect occurred in patients aged 75 or older: In this subgroup, treatment with stenting more than doubled the total stroke risk, both periprocedural and long-term strokes, compared with patients who were treated with CEA.

The incidence of MI showed a much weaker age effect, and patients who underwent stenting had a reduced rate of MI at all ages, compared with those who had CEA. In addition, in the CEA arm, age had no significant effect on the MI rate, Dr. George Howard said.

Commenting on the study, Christopher J. Moran, M.D., is a professor of radiology and neurological surgery at Washington University in St. Louis, who performs carotid artery stenting but did not participate in CREST, stated, “If you are trying to prevent strokes in patients with carotid artery disease, you would have to think long and hard before treating a woman with carotid stenting. In some cases, CEA may not be an option: The woman may be a poor operative candidate because she has a large neck, or the lesion may be high above the mandible and hard to get above."

In addition, some patients have pulmonary disease and are not good candidates for anesthesia. But if a woman is a good operative candidate, she should be treated with endarterectomy.

Conventional angiography or CT angiography lets an operator assess the size of a woman's arteries, he said.

“The smallest self-expanding stents available for treating carotid disease are 5 mm in diameter, and because these are ideally oversized to the artery, the smallest diameter carotid that should be stented is 4 mm. Many women have carotids that are smaller than 4 mm, and in those cases you should definitely think twice about stenting.

“The same considerations apply to patients who are 70-80 years old. If they are good operative candidates, they should undergo CEA," he concluded.

LOS ANGELES - Women, as well as all patients aged 65 years or older who have substantial carotid artery stenosis that needs revascularization, may prefer endarterectomy, and would want to steer clear of carotid stenting, according to new data from CREST, the largest randomized trial to compare these two carotid interventions.

All patients aged 65 or older who were randomized to treatment by carotid artery stenting had a statistically significant excess of strokes, compared with similar subgroups who were treated with CEA during the periprocedural period and 4-year follow-up, George Howard, Dr.P.H., said at the conference. “Patient age should be an important factor in selecting the treatment option for carotid stenosis," said Dr. Howard, professor and chairman of biostatistics at the University of Alabama at Birmingham.

Analysis of the patients enrolled in CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial) by sex showed that the treatment of carotid stenosis by stenting led to an excess rate of periprocedural strokes among women, but not in men, Virginia J. Howard, Ph.D., said in a separate talk at the conference. Women who underwent an endarterectomy also had no excess risk for myocardial infarctions, compared with women who received a carotid stent, unlike men who had a significantly increased rate of MIs following open surgery, compared with those who got stented, said Dr. Howard, an epidemiologist at the University of Alabama at Birmingham.

The primary results from CREST, first reported last year, showed that all patients who were enrolled in the study had similar rates of stroke, MI, or death regardless of whether they underwent carotid CEA or stenting (N. Engl. J. Med. 2010;363:11-23).

But these new details, which show an excess rate of periprocedural strokes in women undergoing stenting as well as the excess of all strokes in patients aged 65 or older undergoing stenting, may tip the balance away from stenting in these patients.

Going into CREST, which began in 2000, “we thought the results would be the opposite. [At that time,] we preferred to take older patients to stenting," commented Dr. Thomas G. Brott, lead investigator for CREST and a professor of neurology and director or research at the Mayo Clinic in Jacksonville, Fla. “Our interventionalists believe that age is a surrogate marker for patients with calcified and tortuous vessels that might not be suitable for stenting." Regarding the sex-related finding, the implications “depend on how a woman would value [the risk of having] a stroke or a MI. If the woman is more concerned about a periprocedural stroke, then the results suggest there could be a preference for endarterectomy," Dr. Brott said in an interview.

In the sex-based analysis, the rate of periprocedural stroke was 5.5% in stented women and 2.2% in those who underwent CEA, a statistically significant 2.6-fold increased rate with stenting, Dr. Virginia Howard reported.

During the entire follow-up, which added the rate of ipsilateral strokes during 4 years following the intervention, stroke rates were 7.8% in stented women and 5.0% in those who had endarterectomy, a nonsignificant difference. The two treatment options produced no difference in stroke rates in men, either periprocedurally or after 4 years. MI rates were similar in women following either intervention, both periprocedurally and after 4 years. The periprocedural and 4-year MI rates in men were significantly higher with CEA.

In the age-based analyses, a calculation that used age as a continuous variable showed that the number of strokes occurring with either CEA or stenting was similar for patients aged 64 years. For those aged 65 or older, fewer strokes occurred with CEA, a relationship that grew stronger with increasing age. For patients aged 63 or younger, stenting produced fewer strokes, and the relationship grew stronger with decreasing age.

The age analysis also divided patients into three prespecified age groups: younger than 65, 65-74 years, and 75 and older. (See box.) The most striking age effect occurred in patients aged 75 or older: In this subgroup, treatment with stenting more than doubled the total stroke risk, both periprocedural and long-term strokes, compared with patients who were treated with CEA.

The incidence of MI showed a much weaker age effect, and patients who underwent stenting had a reduced rate of MI at all ages, compared with those who had CEA. In addition, in the CEA arm, age had no significant effect on the MI rate, Dr. George Howard said.

Commenting on the study, Christopher J. Moran, M.D., is a professor of radiology and neurological surgery at Washington University in St. Louis, who performs carotid artery stenting but did not participate in CREST, stated, “If you are trying to prevent strokes in patients with carotid artery disease, you would have to think long and hard before treating a woman with carotid stenting. In some cases, CEA may not be an option: The woman may be a poor operative candidate because she has a large neck, or the lesion may be high above the mandible and hard to get above."

In addition, some patients have pulmonary disease and are not good candidates for anesthesia. But if a woman is a good operative candidate, she should be treated with endarterectomy.

Conventional angiography or CT angiography lets an operator assess the size of a woman's arteries, he said.

“The smallest self-expanding stents available for treating carotid disease are 5 mm in diameter, and because these are ideally oversized to the artery, the smallest diameter carotid that should be stented is 4 mm. Many women have carotids that are smaller than 4 mm, and in those cases you should definitely think twice about stenting.

“The same considerations apply to patients who are 70-80 years old. If they are good operative candidates, they should undergo CEA," he concluded.

LOS ANGELES - Women, as well as all patients aged 65 years or older who have substantial carotid artery stenosis that needs revascularization, may prefer endarterectomy, and would want to steer clear of carotid stenting, according to new data from CREST, the largest randomized trial to compare these two carotid interventions.

All patients aged 65 or older who were randomized to treatment by carotid artery stenting had a statistically significant excess of strokes, compared with similar subgroups who were treated with CEA during the periprocedural period and 4-year follow-up, George Howard, Dr.P.H., said at the conference. “Patient age should be an important factor in selecting the treatment option for carotid stenosis," said Dr. Howard, professor and chairman of biostatistics at the University of Alabama at Birmingham.

Analysis of the patients enrolled in CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial) by sex showed that the treatment of carotid stenosis by stenting led to an excess rate of periprocedural strokes among women, but not in men, Virginia J. Howard, Ph.D., said in a separate talk at the conference. Women who underwent an endarterectomy also had no excess risk for myocardial infarctions, compared with women who received a carotid stent, unlike men who had a significantly increased rate of MIs following open surgery, compared with those who got stented, said Dr. Howard, an epidemiologist at the University of Alabama at Birmingham.

The primary results from CREST, first reported last year, showed that all patients who were enrolled in the study had similar rates of stroke, MI, or death regardless of whether they underwent carotid CEA or stenting (N. Engl. J. Med. 2010;363:11-23).

But these new details, which show an excess rate of periprocedural strokes in women undergoing stenting as well as the excess of all strokes in patients aged 65 or older undergoing stenting, may tip the balance away from stenting in these patients.

Going into CREST, which began in 2000, “we thought the results would be the opposite. [At that time,] we preferred to take older patients to stenting," commented Dr. Thomas G. Brott, lead investigator for CREST and a professor of neurology and director or research at the Mayo Clinic in Jacksonville, Fla. “Our interventionalists believe that age is a surrogate marker for patients with calcified and tortuous vessels that might not be suitable for stenting." Regarding the sex-related finding, the implications “depend on how a woman would value [the risk of having] a stroke or a MI. If the woman is more concerned about a periprocedural stroke, then the results suggest there could be a preference for endarterectomy," Dr. Brott said in an interview.

In the sex-based analysis, the rate of periprocedural stroke was 5.5% in stented women and 2.2% in those who underwent CEA, a statistically significant 2.6-fold increased rate with stenting, Dr. Virginia Howard reported.

During the entire follow-up, which added the rate of ipsilateral strokes during 4 years following the intervention, stroke rates were 7.8% in stented women and 5.0% in those who had endarterectomy, a nonsignificant difference. The two treatment options produced no difference in stroke rates in men, either periprocedurally or after 4 years. MI rates were similar in women following either intervention, both periprocedurally and after 4 years. The periprocedural and 4-year MI rates in men were significantly higher with CEA.

In the age-based analyses, a calculation that used age as a continuous variable showed that the number of strokes occurring with either CEA or stenting was similar for patients aged 64 years. For those aged 65 or older, fewer strokes occurred with CEA, a relationship that grew stronger with increasing age. For patients aged 63 or younger, stenting produced fewer strokes, and the relationship grew stronger with decreasing age.

The age analysis also divided patients into three prespecified age groups: younger than 65, 65-74 years, and 75 and older. (See box.) The most striking age effect occurred in patients aged 75 or older: In this subgroup, treatment with stenting more than doubled the total stroke risk, both periprocedural and long-term strokes, compared with patients who were treated with CEA.

The incidence of MI showed a much weaker age effect, and patients who underwent stenting had a reduced rate of MI at all ages, compared with those who had CEA. In addition, in the CEA arm, age had no significant effect on the MI rate, Dr. George Howard said.

Commenting on the study, Christopher J. Moran, M.D., is a professor of radiology and neurological surgery at Washington University in St. Louis, who performs carotid artery stenting but did not participate in CREST, stated, “If you are trying to prevent strokes in patients with carotid artery disease, you would have to think long and hard before treating a woman with carotid stenting. In some cases, CEA may not be an option: The woman may be a poor operative candidate because she has a large neck, or the lesion may be high above the mandible and hard to get above."

In addition, some patients have pulmonary disease and are not good candidates for anesthesia. But if a woman is a good operative candidate, she should be treated with endarterectomy.

Conventional angiography or CT angiography lets an operator assess the size of a woman's arteries, he said.

“The smallest self-expanding stents available for treating carotid disease are 5 mm in diameter, and because these are ideally oversized to the artery, the smallest diameter carotid that should be stented is 4 mm. Many women have carotids that are smaller than 4 mm, and in those cases you should definitely think twice about stenting.

“The same considerations apply to patients who are 70-80 years old. If they are good operative candidates, they should undergo CEA," he concluded.

LOS ANGELES - Although patients with carotid artery stenosis randomized to the stenting arm of the CREST generally had better health status measures at 2 and 4 weeks following their intervention, by 1 year “all between-group differences had entirely resolved” when compared with the patients randomized to carotid endarterectomy, Dr. Joshua M. Stolker said at the International Stroke Conference.

The two treatment alternatives tested in the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) led to nearly identical long-term outcomes for quality-of-life despite an excess of strokes in the carotid stenting arm, and despite the finding in a new, exploratory analysis of health status outcomes that strokes produced a markedly larger decrement in health status than did myocardial infarctions or cranial nerve palsy. The worse outcomes with stroke probably did not affect the overall outcome of the stented patients because the number of strokes - and especially the number of major strokes - was relatively small in CREST, “so overall, there was no difference for the whole population despite the impact of stroke,” said Dr. Stolker, a cardiologist at Saint Louis University. In CREST, stented patients had a 1.8% higher rate of all strokes, compared with the endarterectomy patients, including a 0.5% excess rate of major strokes.

Stroke patients showed statistically significant impairments, compared with the patients without stroke, in seven of the eight health status outcome subscales measured using the Short Form (SF)-36: physical function, role physical, vitality, pain, social function, role emotional, and mental health. In contrast, after 1 year patients who had an MI following their surgery had a deficit only in the measure of general health, compared with the patients who did not have an MI. And patients who developed cranial-nerve palsy after their surgery had no 1-year deficits for any health-status measure, compared with the patients who did not develop cranial-nerve palsy.

These results “confirmed what a lot of us already suspected, that periprocedural stroke had a significant impact on 1-year health status across multiple SF-36 outcomes, but periprocedural MI and cranial-nerve palsy did not,” Dr. Stolker said.

The greatest impact on health status occurred in patients with major periprocedural strokes, who on average showed significant reductions in all eight subscales of the SF-36 at 1-year follow-up. Patients with minor periprocedural strokes had, on average, significant 1-year drops in “three or four” SF-36 subscales, compared with CREST patients who did not have strokes.

CREST randomized more than 2,500 patients. The study's primary end point results - the periprocedural rate of stroke, MI, or death plus the 4-year rate of ipsilateral stroke - showed no significant difference between the two study arms, according to results reported last year (N. Engl. J. Med. 2010;363:11-23). Dr. Stolker's new report focused on a prespecified analysis of health status outcomes.

In addition to the eight subscales of the SF-36, the researchers also measured changes in health status by six parameters measures by modified Likert scales: difficulty walking, difficulty eating and swallowing, difficulty driving, headaches, neck pain, and leg pain. The new analysis showed that at 2 weeks after the interventions, patients who had undergone carotid stenting had, on average, significantly better health-status scores for five of the eight SF-36 subscales. One year after the intervention, both the stented and open surgery arms showed, on average, nearly identical scores for all subscales.

The six additional parameters scored on a modified Likert scale showed a roughly similar pattern. After 2 weeks, the stented patients had significantly better scores for difficulty eating and swallowing, difficulty driving, headache, and neck pain, while the endarterectomy patients had a significant edge for difficulty walking and leg pain. These between-group differences began diminishing at 4 weeks and, at 1 year after the intervention, neither procedure had a significant difference for any of the six measures.

CREST was funded by the NIH, and  Abbott Vascular Solutions, the company that markets the stent and embolic protection device used in the study.

LOS ANGELES - Although patients with carotid artery stenosis randomized to the stenting arm of the CREST generally had better health status measures at 2 and 4 weeks following their intervention, by 1 year “all between-group differences had entirely resolved” when compared with the patients randomized to carotid endarterectomy, Dr. Joshua M. Stolker said at the International Stroke Conference.

The two treatment alternatives tested in the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) led to nearly identical long-term outcomes for quality-of-life despite an excess of strokes in the carotid stenting arm, and despite the finding in a new, exploratory analysis of health status outcomes that strokes produced a markedly larger decrement in health status than did myocardial infarctions or cranial nerve palsy. The worse outcomes with stroke probably did not affect the overall outcome of the stented patients because the number of strokes - and especially the number of major strokes - was relatively small in CREST, “so overall, there was no difference for the whole population despite the impact of stroke,” said Dr. Stolker, a cardiologist at Saint Louis University. In CREST, stented patients had a 1.8% higher rate of all strokes, compared with the endarterectomy patients, including a 0.5% excess rate of major strokes.

Stroke patients showed statistically significant impairments, compared with the patients without stroke, in seven of the eight health status outcome subscales measured using the Short Form (SF)-36: physical function, role physical, vitality, pain, social function, role emotional, and mental health. In contrast, after 1 year patients who had an MI following their surgery had a deficit only in the measure of general health, compared with the patients who did not have an MI. And patients who developed cranial-nerve palsy after their surgery had no 1-year deficits for any health-status measure, compared with the patients who did not develop cranial-nerve palsy.

These results “confirmed what a lot of us already suspected, that periprocedural stroke had a significant impact on 1-year health status across multiple SF-36 outcomes, but periprocedural MI and cranial-nerve palsy did not,” Dr. Stolker said.

The greatest impact on health status occurred in patients with major periprocedural strokes, who on average showed significant reductions in all eight subscales of the SF-36 at 1-year follow-up. Patients with minor periprocedural strokes had, on average, significant 1-year drops in “three or four” SF-36 subscales, compared with CREST patients who did not have strokes.

CREST randomized more than 2,500 patients. The study's primary end point results - the periprocedural rate of stroke, MI, or death plus the 4-year rate of ipsilateral stroke - showed no significant difference between the two study arms, according to results reported last year (N. Engl. J. Med. 2010;363:11-23). Dr. Stolker's new report focused on a prespecified analysis of health status outcomes.

In addition to the eight subscales of the SF-36, the researchers also measured changes in health status by six parameters measures by modified Likert scales: difficulty walking, difficulty eating and swallowing, difficulty driving, headaches, neck pain, and leg pain. The new analysis showed that at 2 weeks after the interventions, patients who had undergone carotid stenting had, on average, significantly better health-status scores for five of the eight SF-36 subscales. One year after the intervention, both the stented and open surgery arms showed, on average, nearly identical scores for all subscales.

The six additional parameters scored on a modified Likert scale showed a roughly similar pattern. After 2 weeks, the stented patients had significantly better scores for difficulty eating and swallowing, difficulty driving, headache, and neck pain, while the endarterectomy patients had a significant edge for difficulty walking and leg pain. These between-group differences began diminishing at 4 weeks and, at 1 year after the intervention, neither procedure had a significant difference for any of the six measures.

CREST was funded by the NIH, and  Abbott Vascular Solutions, the company that markets the stent and embolic protection device used in the study.

LOS ANGELES - Although patients with carotid artery stenosis randomized to the stenting arm of the CREST generally had better health status measures at 2 and 4 weeks following their intervention, by 1 year “all between-group differences had entirely resolved” when compared with the patients randomized to carotid endarterectomy, Dr. Joshua M. Stolker said at the International Stroke Conference.

The two treatment alternatives tested in the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) led to nearly identical long-term outcomes for quality-of-life despite an excess of strokes in the carotid stenting arm, and despite the finding in a new, exploratory analysis of health status outcomes that strokes produced a markedly larger decrement in health status than did myocardial infarctions or cranial nerve palsy. The worse outcomes with stroke probably did not affect the overall outcome of the stented patients because the number of strokes - and especially the number of major strokes - was relatively small in CREST, “so overall, there was no difference for the whole population despite the impact of stroke,” said Dr. Stolker, a cardiologist at Saint Louis University. In CREST, stented patients had a 1.8% higher rate of all strokes, compared with the endarterectomy patients, including a 0.5% excess rate of major strokes.

Stroke patients showed statistically significant impairments, compared with the patients without stroke, in seven of the eight health status outcome subscales measured using the Short Form (SF)-36: physical function, role physical, vitality, pain, social function, role emotional, and mental health. In contrast, after 1 year patients who had an MI following their surgery had a deficit only in the measure of general health, compared with the patients who did not have an MI. And patients who developed cranial-nerve palsy after their surgery had no 1-year deficits for any health-status measure, compared with the patients who did not develop cranial-nerve palsy.

These results “confirmed what a lot of us already suspected, that periprocedural stroke had a significant impact on 1-year health status across multiple SF-36 outcomes, but periprocedural MI and cranial-nerve palsy did not,” Dr. Stolker said.

The greatest impact on health status occurred in patients with major periprocedural strokes, who on average showed significant reductions in all eight subscales of the SF-36 at 1-year follow-up. Patients with minor periprocedural strokes had, on average, significant 1-year drops in “three or four” SF-36 subscales, compared with CREST patients who did not have strokes.

CREST randomized more than 2,500 patients. The study's primary end point results - the periprocedural rate of stroke, MI, or death plus the 4-year rate of ipsilateral stroke - showed no significant difference between the two study arms, according to results reported last year (N. Engl. J. Med. 2010;363:11-23). Dr. Stolker's new report focused on a prespecified analysis of health status outcomes.

In addition to the eight subscales of the SF-36, the researchers also measured changes in health status by six parameters measures by modified Likert scales: difficulty walking, difficulty eating and swallowing, difficulty driving, headaches, neck pain, and leg pain. The new analysis showed that at 2 weeks after the interventions, patients who had undergone carotid stenting had, on average, significantly better health-status scores for five of the eight SF-36 subscales. One year after the intervention, both the stented and open surgery arms showed, on average, nearly identical scores for all subscales.

The six additional parameters scored on a modified Likert scale showed a roughly similar pattern. After 2 weeks, the stented patients had significantly better scores for difficulty eating and swallowing, difficulty driving, headache, and neck pain, while the endarterectomy patients had a significant edge for difficulty walking and leg pain. These between-group differences began diminishing at 4 weeks and, at 1 year after the intervention, neither procedure had a significant difference for any of the six measures.

CREST was funded by the NIH, and  Abbott Vascular Solutions, the company that markets the stent and embolic protection device used in the study.

NEW YORK – The incidence of gestational diabetes will rise substantially now that the American Diabetes Association has formally adopted new diagnostic criteria, especially in selected regions where pregnant woman may be older or have a higher prevalence of obesity.

Among the 15 geographically diverse communities that participated in the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study, the results of which led to the new ADA guidelines, the incidence of gestational diabetes ran as high as 24%, in Cleveland, while also reaching a low of 9%, in two communities in Israel.

The overall gestational diabetes incidence rate in HAPO averaged 16%, Dr. Boyd E. Metzger said at the meeting, sponsored by the American Diabetes Association, strikingly above the 7% rate documented as recently as 2005 in a large group of women from southern California (Diabetes Care 2008;31:899-904). But Dr. Metzger also expressed optimism that most of the added new cases of gestational diabetes that the new criteria identify will respond to lifestyle management, and that the net result of broader diagnosis and treatment will be a substantially reduced rate of adverse sequelae.

“The mild gestational diabetes that makes up the expanded population should be patients we can successfully manage with less expensive” lifestyle treatment, said Dr. Metzger, a professor of nutrition and metabolism at Northwestern University in Chicago. The increased numbers may also include “a modest increase in those who need drug treatment.” In general, “a more aggressive approach to diagnosis and treatment should lead to a reduction in complications of gestational diabetes. It would be disappointing if we can't achieve in the real world what the research study showed,” he said in an interview.

The new gestational diabetes diagnostic criteria received formal adoption from the American Diabetes Association in the group's annual position statement on Standards of Medical Care in Diabetes, published in January (Diabetes Care 2011;34:S11-61). The Standards' section on the detection and diagnosis of gestational diabetes cited the 2008 HAPO study (N. Engl. J. Med. 2008;358:1991-2002) as the basis for the new diagnostic criteria.

An initial proposal of the new criteria came from the International Association of Diabetes and Pregnancy Study Groups Consensus Panel last year, which recommended criteria to identify a woman with gestational diabetes if at week 24-28 her fasting plasma glucose was at least 92 mg/dL, or her plasma glucose 1 hour after an oral glucose challenge was at least 180 mg/dL, or her plasma glucose 2 hours after the glucose challenge was at least 153 mg/dL.

The new criteria “are not very different from the old ADA criteria. The biggest single difference is that any one of these criteria diagnoses an abnormal glucose level rather than requiring woman to meet at least two of the criteria,” said Dr. Metzger, lead author for both HAPO and for the IADPSG. This easing to allow diagnosis based on just one criterion “accounts for a lot of the increase in numbers,” he said. In the HAPO findings from more than 23,000 women, the fasting plasma glucose criterion diagnosed 8.3% of the women as having gestational diabetes, the 1-hour postchallenge plasma glucose level identified an additional 5.7% of women with gestational diabetes, and the 2-hour post-challenge glucose level identified another 2.1% with gestational diabetes, together totaling just over 16% with the diagnosis.

Data documenting the broad range of geographic variation in gestational diabetes incidence appeared in a report presented by a group of HAPO investigators, including Dr. Metzger, last September at the annual meeting of the European Association for the Study of Diabetes in Stockholm.

According to that report, 5 of the 15 HAPO sites had rates of 21%-24%, led by Cleveland with the highest rate and followed by Bellflower, Calif.; Singapore; Bangkok; and Manchester, England. Two different communities contributing data in Israel both had 9% rates, with the remaining eight sites having gestational diabetes rates of 10%-17%.

Having new diagnostic criteria also raises the question of whether treatment goals will need changing, said Dr. Metzger.

“We would like to get women [diagnosed with gestational diabetes] to a fasting plasma glucose of 90 mg/dL or below. When the diagnostic threshold is 92 mg/dL, if we don't get them to below then we are not changing their risk,” he said. But “we are not proponents of oral agents” for treating gestational diabetes.

“I don't have a lot of experience using the new criteria,” he admitted. “We just introduced them [at Northwestern University Medical Center] in January,” after their official endorsement from the ADA, Dr. Metzger said.

“We don't yet have the data to make new treatment recommendations. The right treatment targets will need to be defined by results from additional studies.”

Dr. Metzger said that he had no disclosures.

The increased number may also include 'a modest increase in those who need drug treatment.'

Source DR. METZGER

Source Elsevier Global Medical News

NEW YORK – The incidence of gestational diabetes will rise substantially now that the American Diabetes Association has formally adopted new diagnostic criteria, especially in selected regions where pregnant woman may be older or have a higher prevalence of obesity.

Among the 15 geographically diverse communities that participated in the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study, the results of which led to the new ADA guidelines, the incidence of gestational diabetes ran as high as 24%, in Cleveland, while also reaching a low of 9%, in two communities in Israel.

The overall gestational diabetes incidence rate in HAPO averaged 16%, Dr. Boyd E. Metzger said at the meeting, sponsored by the American Diabetes Association, strikingly above the 7% rate documented as recently as 2005 in a large group of women from southern California (Diabetes Care 2008;31:899-904). But Dr. Metzger also expressed optimism that most of the added new cases of gestational diabetes that the new criteria identify will respond to lifestyle management, and that the net result of broader diagnosis and treatment will be a substantially reduced rate of adverse sequelae.

“The mild gestational diabetes that makes up the expanded population should be patients we can successfully manage with less expensive” lifestyle treatment, said Dr. Metzger, a professor of nutrition and metabolism at Northwestern University in Chicago. The increased numbers may also include “a modest increase in those who need drug treatment.” In general, “a more aggressive approach to diagnosis and treatment should lead to a reduction in complications of gestational diabetes. It would be disappointing if we can't achieve in the real world what the research study showed,” he said in an interview.

The new gestational diabetes diagnostic criteria received formal adoption from the American Diabetes Association in the group's annual position statement on Standards of Medical Care in Diabetes, published in January (Diabetes Care 2011;34:S11-61). The Standards' section on the detection and diagnosis of gestational diabetes cited the 2008 HAPO study (N. Engl. J. Med. 2008;358:1991-2002) as the basis for the new diagnostic criteria.

An initial proposal of the new criteria came from the International Association of Diabetes and Pregnancy Study Groups Consensus Panel last year, which recommended criteria to identify a woman with gestational diabetes if at week 24-28 her fasting plasma glucose was at least 92 mg/dL, or her plasma glucose 1 hour after an oral glucose challenge was at least 180 mg/dL, or her plasma glucose 2 hours after the glucose challenge was at least 153 mg/dL.

The new criteria “are not very different from the old ADA criteria. The biggest single difference is that any one of these criteria diagnoses an abnormal glucose level rather than requiring woman to meet at least two of the criteria,” said Dr. Metzger, lead author for both HAPO and for the IADPSG. This easing to allow diagnosis based on just one criterion “accounts for a lot of the increase in numbers,” he said. In the HAPO findings from more than 23,000 women, the fasting plasma glucose criterion diagnosed 8.3% of the women as having gestational diabetes, the 1-hour postchallenge plasma glucose level identified an additional 5.7% of women with gestational diabetes, and the 2-hour post-challenge glucose level identified another 2.1% with gestational diabetes, together totaling just over 16% with the diagnosis.

Data documenting the broad range of geographic variation in gestational diabetes incidence appeared in a report presented by a group of HAPO investigators, including Dr. Metzger, last September at the annual meeting of the European Association for the Study of Diabetes in Stockholm.

According to that report, 5 of the 15 HAPO sites had rates of 21%-24%, led by Cleveland with the highest rate and followed by Bellflower, Calif.; Singapore; Bangkok; and Manchester, England. Two different communities contributing data in Israel both had 9% rates, with the remaining eight sites having gestational diabetes rates of 10%-17%.

Having new diagnostic criteria also raises the question of whether treatment goals will need changing, said Dr. Metzger.

“We would like to get women [diagnosed with gestational diabetes] to a fasting plasma glucose of 90 mg/dL or below. When the diagnostic threshold is 92 mg/dL, if we don't get them to below then we are not changing their risk,” he said. But “we are not proponents of oral agents” for treating gestational diabetes.

“I don't have a lot of experience using the new criteria,” he admitted. “We just introduced them [at Northwestern University Medical Center] in January,” after their official endorsement from the ADA, Dr. Metzger said.

“We don't yet have the data to make new treatment recommendations. The right treatment targets will need to be defined by results from additional studies.”

Dr. Metzger said that he had no disclosures.

The increased number may also include 'a modest increase in those who need drug treatment.'

Source DR. METZGER

Source Elsevier Global Medical News

NEW YORK – The incidence of gestational diabetes will rise substantially now that the American Diabetes Association has formally adopted new diagnostic criteria, especially in selected regions where pregnant woman may be older or have a higher prevalence of obesity.

Among the 15 geographically diverse communities that participated in the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study, the results of which led to the new ADA guidelines, the incidence of gestational diabetes ran as high as 24%, in Cleveland, while also reaching a low of 9%, in two communities in Israel.

The overall gestational diabetes incidence rate in HAPO averaged 16%, Dr. Boyd E. Metzger said at the meeting, sponsored by the American Diabetes Association, strikingly above the 7% rate documented as recently as 2005 in a large group of women from southern California (Diabetes Care 2008;31:899-904). But Dr. Metzger also expressed optimism that most of the added new cases of gestational diabetes that the new criteria identify will respond to lifestyle management, and that the net result of broader diagnosis and treatment will be a substantially reduced rate of adverse sequelae.

“The mild gestational diabetes that makes up the expanded population should be patients we can successfully manage with less expensive” lifestyle treatment, said Dr. Metzger, a professor of nutrition and metabolism at Northwestern University in Chicago. The increased numbers may also include “a modest increase in those who need drug treatment.” In general, “a more aggressive approach to diagnosis and treatment should lead to a reduction in complications of gestational diabetes. It would be disappointing if we can't achieve in the real world what the research study showed,” he said in an interview.

The new gestational diabetes diagnostic criteria received formal adoption from the American Diabetes Association in the group's annual position statement on Standards of Medical Care in Diabetes, published in January (Diabetes Care 2011;34:S11-61). The Standards' section on the detection and diagnosis of gestational diabetes cited the 2008 HAPO study (N. Engl. J. Med. 2008;358:1991-2002) as the basis for the new diagnostic criteria.

An initial proposal of the new criteria came from the International Association of Diabetes and Pregnancy Study Groups Consensus Panel last year, which recommended criteria to identify a woman with gestational diabetes if at week 24-28 her fasting plasma glucose was at least 92 mg/dL, or her plasma glucose 1 hour after an oral glucose challenge was at least 180 mg/dL, or her plasma glucose 2 hours after the glucose challenge was at least 153 mg/dL.

The new criteria “are not very different from the old ADA criteria. The biggest single difference is that any one of these criteria diagnoses an abnormal glucose level rather than requiring woman to meet at least two of the criteria,” said Dr. Metzger, lead author for both HAPO and for the IADPSG. This easing to allow diagnosis based on just one criterion “accounts for a lot of the increase in numbers,” he said. In the HAPO findings from more than 23,000 women, the fasting plasma glucose criterion diagnosed 8.3% of the women as having gestational diabetes, the 1-hour postchallenge plasma glucose level identified an additional 5.7% of women with gestational diabetes, and the 2-hour post-challenge glucose level identified another 2.1% with gestational diabetes, together totaling just over 16% with the diagnosis.

Data documenting the broad range of geographic variation in gestational diabetes incidence appeared in a report presented by a group of HAPO investigators, including Dr. Metzger, last September at the annual meeting of the European Association for the Study of Diabetes in Stockholm.

According to that report, 5 of the 15 HAPO sites had rates of 21%-24%, led by Cleveland with the highest rate and followed by Bellflower, Calif.; Singapore; Bangkok; and Manchester, England. Two different communities contributing data in Israel both had 9% rates, with the remaining eight sites having gestational diabetes rates of 10%-17%.

Having new diagnostic criteria also raises the question of whether treatment goals will need changing, said Dr. Metzger.

“We would like to get women [diagnosed with gestational diabetes] to a fasting plasma glucose of 90 mg/dL or below. When the diagnostic threshold is 92 mg/dL, if we don't get them to below then we are not changing their risk,” he said. But “we are not proponents of oral agents” for treating gestational diabetes.

“I don't have a lot of experience using the new criteria,” he admitted. “We just introduced them [at Northwestern University Medical Center] in January,” after their official endorsement from the ADA, Dr. Metzger said.

“We don't yet have the data to make new treatment recommendations. The right treatment targets will need to be defined by results from additional studies.”

Dr. Metzger said that he had no disclosures.

The increased number may also include 'a modest increase in those who need drug treatment.'

Source DR. METZGER

Source Elsevier Global Medical News

Major Finding: Continuous low-voltage stimulation of the carotid sinus by an implanted device led to blood pressure reductions in patients with drug-resistant hypertension. The trial results fulfilled three of five prespecified efficacy and safety goals.

Data Source: The Rheos Pivotal Trial, which enrolled 265 patients with drug-resistant hypertension who received an implanted baroreflex activation device at 37 U.S. centers and 2 centers in Europe.

Disclosures: Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram has served on the speakers bureau for the Peer Group and for Advanced Health Media.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The trial results “justify further development” of baroreflex activation therapy, Dr. John D. Bisognano said at the meeting.

“This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit,” said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient's clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient's neck.

The device delivers a continuous electrical current of 1-6 V to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

“When the device becomes available, the greatest benefit will be in patients with end-stage renal failure.

“No matter what you do, their blood pressure does not go down,” commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. “I just hope that patients tolerate” having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakesh C. Deedwania took a more skeptical view of the approach. “This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension,” he said.

The current study's design also “left many unanswered questions,” said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno. (See View on the News at bottom right.)

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and 2 centers in Europe. All 265 patients who were enrolled received placement of the device.

One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white.

Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry.

During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs.

Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min.

To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg and a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end points.

One end point assessed short-term response after 6 months, defining success as at least a 10–mm Hg drop in systolic pressure compared with baseline. This criterion for success occurred in 54% of patients with an activated device in the study's first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference.

Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10–mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm.

The results showed that patients receiving activation had a 2% reduced rate of adverse events compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months.

The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg.

At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference.

At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape.

At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m

A year later, the average had dropped to 102 kg/m

Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

'I anticipate further studies to better define which patients get the greatest benefit.'

Source DR. BISOGNANO

View on the News

Efficacy Questions Left Unanswered

The results from this study leave many questions unanswered about the efficacy of this approach to treating persistent, treatment-resistant hypertension.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause.

The study's design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51: 1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients.

I participated in research several years ago that tested baroreflex activation as a treatment for refractory angina. This approach did not pan out because, while the treatment showed initial efficacy, the effect declined over the longer term.

In my opinion, renal artery denervation is, for now, a more proven, novel way to manage patients with hypertension that is truly drug resistant. Carotid baroreflex activation will require more study and better evidence before we can consider it a new option for these patients.

PRAKASH C. DEEDWANIA, M.D., is professor of medicine with the University of California, San Francisco, in Fresno. He said he had no relevant financial disclosures.

Major Finding: Continuous low-voltage stimulation of the carotid sinus by an implanted device led to blood pressure reductions in patients with drug-resistant hypertension. The trial results fulfilled three of five prespecified efficacy and safety goals.

Data Source: The Rheos Pivotal Trial, which enrolled 265 patients with drug-resistant hypertension who received an implanted baroreflex activation device at 37 U.S. centers and 2 centers in Europe.

Disclosures: Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram has served on the speakers bureau for the Peer Group and for Advanced Health Media.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The trial results “justify further development” of baroreflex activation therapy, Dr. John D. Bisognano said at the meeting.

“This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit,” said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient's clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient's neck.

The device delivers a continuous electrical current of 1-6 V to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

“When the device becomes available, the greatest benefit will be in patients with end-stage renal failure.

“No matter what you do, their blood pressure does not go down,” commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. “I just hope that patients tolerate” having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakesh C. Deedwania took a more skeptical view of the approach. “This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension,” he said.

The current study's design also “left many unanswered questions,” said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno. (See View on the News at bottom right.)

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and 2 centers in Europe. All 265 patients who were enrolled received placement of the device.

One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white.

Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry.

During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs.

Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min.

To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg and a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end points.

One end point assessed short-term response after 6 months, defining success as at least a 10–mm Hg drop in systolic pressure compared with baseline. This criterion for success occurred in 54% of patients with an activated device in the study's first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference.

Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10–mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm.

The results showed that patients receiving activation had a 2% reduced rate of adverse events compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months.

The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg.

At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference.

At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape.

At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m

A year later, the average had dropped to 102 kg/m

Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

'I anticipate further studies to better define which patients get the greatest benefit.'

Source DR. BISOGNANO

View on the News

Efficacy Questions Left Unanswered

The results from this study leave many questions unanswered about the efficacy of this approach to treating persistent, treatment-resistant hypertension.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause.

The study's design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51: 1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients.

I participated in research several years ago that tested baroreflex activation as a treatment for refractory angina. This approach did not pan out because, while the treatment showed initial efficacy, the effect declined over the longer term.

In my opinion, renal artery denervation is, for now, a more proven, novel way to manage patients with hypertension that is truly drug resistant. Carotid baroreflex activation will require more study and better evidence before we can consider it a new option for these patients.

PRAKASH C. DEEDWANIA, M.D., is professor of medicine with the University of California, San Francisco, in Fresno. He said he had no relevant financial disclosures.

Major Finding: Continuous low-voltage stimulation of the carotid sinus by an implanted device led to blood pressure reductions in patients with drug-resistant hypertension. The trial results fulfilled three of five prespecified efficacy and safety goals.

Data Source: The Rheos Pivotal Trial, which enrolled 265 patients with drug-resistant hypertension who received an implanted baroreflex activation device at 37 U.S. centers and 2 centers in Europe.

Disclosures: Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram has served on the speakers bureau for the Peer Group and for Advanced Health Media.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The trial results “justify further development” of baroreflex activation therapy, Dr. John D. Bisognano said at the meeting.

“This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit,” said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient's clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient's neck.

The device delivers a continuous electrical current of 1-6 V to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

“When the device becomes available, the greatest benefit will be in patients with end-stage renal failure.

“No matter what you do, their blood pressure does not go down,” commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. “I just hope that patients tolerate” having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakesh C. Deedwania took a more skeptical view of the approach. “This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension,” he said.

The current study's design also “left many unanswered questions,” said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno. (See View on the News at bottom right.)

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and 2 centers in Europe. All 265 patients who were enrolled received placement of the device.

One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white.

Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry.

During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs.

Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min.

To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg and a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end points.

One end point assessed short-term response after 6 months, defining success as at least a 10–mm Hg drop in systolic pressure compared with baseline. This criterion for success occurred in 54% of patients with an activated device in the study's first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference.

Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10–mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm.

The results showed that patients receiving activation had a 2% reduced rate of adverse events compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months.

The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg.

At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference.

At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape.

At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m

A year later, the average had dropped to 102 kg/m

Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

'I anticipate further studies to better define which patients get the greatest benefit.'

Source DR. BISOGNANO

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Efficacy Questions Left Unanswered

The results from this study leave many questions unanswered about the efficacy of this approach to treating persistent, treatment-resistant hypertension.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause.

The study's design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51: 1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients.

I participated in research several years ago that tested baroreflex activation as a treatment for refractory angina. This approach did not pan out because, while the treatment showed initial efficacy, the effect declined over the longer term.

In my opinion, renal artery denervation is, for now, a more proven, novel way to manage patients with hypertension that is truly drug resistant. Carotid baroreflex activation will require more study and better evidence before we can consider it a new option for these patients.

PRAKASH C. DEEDWANIA, M.D., is professor of medicine with the University of California, San Francisco, in Fresno. He said he had no relevant financial disclosures.