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M. Alexander Otto began his reporting career early in 1999 covering the pharmaceutical industry for a national pharmacists' magazine and freelancing for the Washington Post and other newspapers. He then joined BNA, now part of Bloomberg News, covering health law and the protection of people and animals in medical research. Alex next worked for the McClatchy Company. Based on his work, Alex won a year-long Knight Science Journalism Fellowship to MIT in 2008-2009. He joined the company shortly thereafter. Alex has a newspaper journalism degree from Syracuse (N.Y.) University and a master's degree in medical science -- a physician assistant degree -- from George Washington University. Alex is based in Seattle.
How to apply SPRINT findings to elderly patients
SAN FRANCISCO – The benefit of lowering blood pressure exceeded the potential for harm, even among the most frail elderly, in SPRINT, but it’s important to remember who was excluded from the trial when using the findings in the clinic, according to Mark Supiano, MD.
SPRINT (Systolic Blood Pressure Intervention Trial) excluded people with histories of stroke, diabetes, heart failure, and chronic kidney disease with a markedly reduced glomerular filtration rate. People living in nursing homes, assisted living centers, and those with prevalent dementia were also excluded, as were individuals with a standing systolic pressure below 110 mm Hg (N Engl J Med. 2015 Nov 26;373:2103-16).
Even with those exclusions, however, the 2,636 patients in SPRINT who were 75 years and older “were not a super healthy group of older people,” Dr. Supiano said at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
They were at high risk for cardiovascular disease (CVD), with a median 10-year Framingham risk score of almost 25%. More than a quarter had gait speeds below 0.8 m/sec, and almost a third were classified as frail. Many had mild cognitive impairment at baseline.
In the United States, Dr. Supiano and his colleagues estimate that there are almost 6 million similar people 75 years or older with hypertension who would likely achieve the same benefits from hypertension control as elderly subjects in the trial. “As a geriatrician, there are very few things that I can offer patients 75 years and older that will have a profound improvement in their overall mortality.” Blood pressure control is one of them, said Dr. Supiano, chief of geriatrics at the University of Utah, Salt Lake City, and a SPRINT investigator.
In SPRINT, intensive treatment to systolic pressure below 120 mm Hg showed greater benefit for patients 75 years and older than it did for younger patients, even among the frail, with a 34% reduction in fatal and nonfatal CVD events versus patients treated to below 140 mm Hg, and a 33% lower rate of death from any cause.
It should be no surprise that older patients had greater benefit from tighter control, because elderly patients have “a greater CVD risk. There’s more bang for the buck” with blood pressure lowering in an older population. “Overall, benefits exceed the potential for harm, even among the frailest older patients,” Dr. Supiano said.
“A systemic target of less than 140 mm Hg is, I believe, appropriate for most healthy people age 60 and older. A benefit-based systemic target of less than 120 mm Hg may be appropriate for those at higher CVD risk.” Among patients 60-75 years old, that would include those with a Framingham score above 15%. Among patients older than age 75 with an elevated CVD risk, treatment to below 120 mm Hg makes sense if it aligns with patient’s goals of care, Dr. Supiano said.
The 120–mm Hg target in SPRINT was associated with a greater incidence of some transient side effects in the elderly, including hypotension, syncope, acute kidney injury, and electrolyte imbalance, but not a higher risk of serious adverse events or injurious falls.
There were concerns raised at the joint sessions about the effect of blood pressure lowering on the cognitive function of older people. Dr. Supiano noted that the cognitive outcomes in SPRINT, as well as outcomes in patients with chronic kidney disease, have not yet been released, but are expected soon.
Dr. Supiano had no relevant disclosures.
SAN FRANCISCO – The benefit of lowering blood pressure exceeded the potential for harm, even among the most frail elderly, in SPRINT, but it’s important to remember who was excluded from the trial when using the findings in the clinic, according to Mark Supiano, MD.
SPRINT (Systolic Blood Pressure Intervention Trial) excluded people with histories of stroke, diabetes, heart failure, and chronic kidney disease with a markedly reduced glomerular filtration rate. People living in nursing homes, assisted living centers, and those with prevalent dementia were also excluded, as were individuals with a standing systolic pressure below 110 mm Hg (N Engl J Med. 2015 Nov 26;373:2103-16).
Even with those exclusions, however, the 2,636 patients in SPRINT who were 75 years and older “were not a super healthy group of older people,” Dr. Supiano said at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
They were at high risk for cardiovascular disease (CVD), with a median 10-year Framingham risk score of almost 25%. More than a quarter had gait speeds below 0.8 m/sec, and almost a third were classified as frail. Many had mild cognitive impairment at baseline.
In the United States, Dr. Supiano and his colleagues estimate that there are almost 6 million similar people 75 years or older with hypertension who would likely achieve the same benefits from hypertension control as elderly subjects in the trial. “As a geriatrician, there are very few things that I can offer patients 75 years and older that will have a profound improvement in their overall mortality.” Blood pressure control is one of them, said Dr. Supiano, chief of geriatrics at the University of Utah, Salt Lake City, and a SPRINT investigator.
In SPRINT, intensive treatment to systolic pressure below 120 mm Hg showed greater benefit for patients 75 years and older than it did for younger patients, even among the frail, with a 34% reduction in fatal and nonfatal CVD events versus patients treated to below 140 mm Hg, and a 33% lower rate of death from any cause.
It should be no surprise that older patients had greater benefit from tighter control, because elderly patients have “a greater CVD risk. There’s more bang for the buck” with blood pressure lowering in an older population. “Overall, benefits exceed the potential for harm, even among the frailest older patients,” Dr. Supiano said.
“A systemic target of less than 140 mm Hg is, I believe, appropriate for most healthy people age 60 and older. A benefit-based systemic target of less than 120 mm Hg may be appropriate for those at higher CVD risk.” Among patients 60-75 years old, that would include those with a Framingham score above 15%. Among patients older than age 75 with an elevated CVD risk, treatment to below 120 mm Hg makes sense if it aligns with patient’s goals of care, Dr. Supiano said.
The 120–mm Hg target in SPRINT was associated with a greater incidence of some transient side effects in the elderly, including hypotension, syncope, acute kidney injury, and electrolyte imbalance, but not a higher risk of serious adverse events or injurious falls.
There were concerns raised at the joint sessions about the effect of blood pressure lowering on the cognitive function of older people. Dr. Supiano noted that the cognitive outcomes in SPRINT, as well as outcomes in patients with chronic kidney disease, have not yet been released, but are expected soon.
Dr. Supiano had no relevant disclosures.
SAN FRANCISCO – The benefit of lowering blood pressure exceeded the potential for harm, even among the most frail elderly, in SPRINT, but it’s important to remember who was excluded from the trial when using the findings in the clinic, according to Mark Supiano, MD.
SPRINT (Systolic Blood Pressure Intervention Trial) excluded people with histories of stroke, diabetes, heart failure, and chronic kidney disease with a markedly reduced glomerular filtration rate. People living in nursing homes, assisted living centers, and those with prevalent dementia were also excluded, as were individuals with a standing systolic pressure below 110 mm Hg (N Engl J Med. 2015 Nov 26;373:2103-16).
Even with those exclusions, however, the 2,636 patients in SPRINT who were 75 years and older “were not a super healthy group of older people,” Dr. Supiano said at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
They were at high risk for cardiovascular disease (CVD), with a median 10-year Framingham risk score of almost 25%. More than a quarter had gait speeds below 0.8 m/sec, and almost a third were classified as frail. Many had mild cognitive impairment at baseline.
In the United States, Dr. Supiano and his colleagues estimate that there are almost 6 million similar people 75 years or older with hypertension who would likely achieve the same benefits from hypertension control as elderly subjects in the trial. “As a geriatrician, there are very few things that I can offer patients 75 years and older that will have a profound improvement in their overall mortality.” Blood pressure control is one of them, said Dr. Supiano, chief of geriatrics at the University of Utah, Salt Lake City, and a SPRINT investigator.
In SPRINT, intensive treatment to systolic pressure below 120 mm Hg showed greater benefit for patients 75 years and older than it did for younger patients, even among the frail, with a 34% reduction in fatal and nonfatal CVD events versus patients treated to below 140 mm Hg, and a 33% lower rate of death from any cause.
It should be no surprise that older patients had greater benefit from tighter control, because elderly patients have “a greater CVD risk. There’s more bang for the buck” with blood pressure lowering in an older population. “Overall, benefits exceed the potential for harm, even among the frailest older patients,” Dr. Supiano said.
“A systemic target of less than 140 mm Hg is, I believe, appropriate for most healthy people age 60 and older. A benefit-based systemic target of less than 120 mm Hg may be appropriate for those at higher CVD risk.” Among patients 60-75 years old, that would include those with a Framingham score above 15%. Among patients older than age 75 with an elevated CVD risk, treatment to below 120 mm Hg makes sense if it aligns with patient’s goals of care, Dr. Supiano said.
The 120–mm Hg target in SPRINT was associated with a greater incidence of some transient side effects in the elderly, including hypotension, syncope, acute kidney injury, and electrolyte imbalance, but not a higher risk of serious adverse events or injurious falls.
There were concerns raised at the joint sessions about the effect of blood pressure lowering on the cognitive function of older people. Dr. Supiano noted that the cognitive outcomes in SPRINT, as well as outcomes in patients with chronic kidney disease, have not yet been released, but are expected soon.
Dr. Supiano had no relevant disclosures.
EXPERT ANALYSIS FROM JOINT HYPERTENSION 2017
Liquid biopsy predicts checkpoint inhibitor response
The overall response rate to immune checkpoint inhibitors was 45% among cancer patients who had more than three variants of unknown significance in their circulating tumor DNA; among those with three or fewer, the response rate was 15%, according to a University of California, San Diego, investigation with 69 subjects.
Higher mutation burdens in circulating tumor DNA (ctDNA) also correlated with improved progression-free and overall survival across 20 cancer types, the investigators reported (Clin Cancer Res. 2017 Oct. 1. doi: 10.1158/1078-0432.CCR-17-1439).
Tumor mutation burdens can predict response to checkpoint inhibitors, but they are usually assessed by tissue biopsy, which is costly and invasive. The findings suggest that blood tests could replace tissue biopsies to green-light immune checkpoint inhibitor treatment.
“Our current results may be clinically exploitable. ... Liquid biopsies that assess blood-derived ctDNA are noninvasive, easily acquired, and inexpensive. The ctDNA derived from blood may also represent shed DNA from multiple metastatic sites, whereas tissue genomics reflects only the piece of tissue removed,” said investigators led by Yulian Khagi, MD, a hematology-oncology fellow at the university.
In a press statement, Dr. Khagi said “If verified by further studies, clinicians will be able to utilize the ... results of this simple blood test to make determinations about whether to use checkpoint inhibitor–based immune therapy in a variety of tumor types.”
The 69 patients were a median of 56 years old, and 43 (62.3%) were men. Melanoma, lung cancer, and head and neck cancer were the most common malignancies. The majority of patients had anti–PD-1 or PD-L1 monotherapy.
For most patients, blood samples were drawn a month or 2 before treatment. Next-generation sequencing (Guardant360) was done on ctDNA to detect alterations in cancer genes. Of the 69 patients, 20 (29%) had more than three variants of unknown significance (VUS); the rest had three or fewer.
The median overall survival was 15.3 months from the start of immunotherapy. For patients with three or fewer VUS, median overall survival was 10.72 months; for patients with more, median overall survival could not be calculated because more than half were alive at the study’s conclusion.
Median progression-fee survival was 2.07 months with three or fewer VUS, versus 3.84 months with more. The findings were statistically significant.
Similar results were found when all genomic alterations, not just VUS, were examined and dichotomized as six or more versus fewer than six.
“The number of genes assayed in our ctDNA analysis was only between 54 and 70. Unlike targeted NGS [next-generation sequencing] of tumor tissue, which often tests for hundreds of genes and allows a relatively accurate estimate of total mutational burden, targeted NGS of plasma ctDNA provides only a limited snapshot of the cancer genome. More extensive ctDNA gene panels merit investigation to determine if they increase the correlative value of our findings,” the investigators said.
The work was funded by the Joan and Irwin Jacobs Fund and the National Cancer Institute. Dr. Khagi had no industry disclosures. Three authors reported financial ties to a number of companies, including Boehringer, Merck, Guardant, and Pfizer. The senior author has ownership interests in CureMatch.
The overall response rate to immune checkpoint inhibitors was 45% among cancer patients who had more than three variants of unknown significance in their circulating tumor DNA; among those with three or fewer, the response rate was 15%, according to a University of California, San Diego, investigation with 69 subjects.
Higher mutation burdens in circulating tumor DNA (ctDNA) also correlated with improved progression-free and overall survival across 20 cancer types, the investigators reported (Clin Cancer Res. 2017 Oct. 1. doi: 10.1158/1078-0432.CCR-17-1439).
Tumor mutation burdens can predict response to checkpoint inhibitors, but they are usually assessed by tissue biopsy, which is costly and invasive. The findings suggest that blood tests could replace tissue biopsies to green-light immune checkpoint inhibitor treatment.
“Our current results may be clinically exploitable. ... Liquid biopsies that assess blood-derived ctDNA are noninvasive, easily acquired, and inexpensive. The ctDNA derived from blood may also represent shed DNA from multiple metastatic sites, whereas tissue genomics reflects only the piece of tissue removed,” said investigators led by Yulian Khagi, MD, a hematology-oncology fellow at the university.
In a press statement, Dr. Khagi said “If verified by further studies, clinicians will be able to utilize the ... results of this simple blood test to make determinations about whether to use checkpoint inhibitor–based immune therapy in a variety of tumor types.”
The 69 patients were a median of 56 years old, and 43 (62.3%) were men. Melanoma, lung cancer, and head and neck cancer were the most common malignancies. The majority of patients had anti–PD-1 or PD-L1 monotherapy.
For most patients, blood samples were drawn a month or 2 before treatment. Next-generation sequencing (Guardant360) was done on ctDNA to detect alterations in cancer genes. Of the 69 patients, 20 (29%) had more than three variants of unknown significance (VUS); the rest had three or fewer.
The median overall survival was 15.3 months from the start of immunotherapy. For patients with three or fewer VUS, median overall survival was 10.72 months; for patients with more, median overall survival could not be calculated because more than half were alive at the study’s conclusion.
Median progression-fee survival was 2.07 months with three or fewer VUS, versus 3.84 months with more. The findings were statistically significant.
Similar results were found when all genomic alterations, not just VUS, were examined and dichotomized as six or more versus fewer than six.
“The number of genes assayed in our ctDNA analysis was only between 54 and 70. Unlike targeted NGS [next-generation sequencing] of tumor tissue, which often tests for hundreds of genes and allows a relatively accurate estimate of total mutational burden, targeted NGS of plasma ctDNA provides only a limited snapshot of the cancer genome. More extensive ctDNA gene panels merit investigation to determine if they increase the correlative value of our findings,” the investigators said.
The work was funded by the Joan and Irwin Jacobs Fund and the National Cancer Institute. Dr. Khagi had no industry disclosures. Three authors reported financial ties to a number of companies, including Boehringer, Merck, Guardant, and Pfizer. The senior author has ownership interests in CureMatch.
The overall response rate to immune checkpoint inhibitors was 45% among cancer patients who had more than three variants of unknown significance in their circulating tumor DNA; among those with three or fewer, the response rate was 15%, according to a University of California, San Diego, investigation with 69 subjects.
Higher mutation burdens in circulating tumor DNA (ctDNA) also correlated with improved progression-free and overall survival across 20 cancer types, the investigators reported (Clin Cancer Res. 2017 Oct. 1. doi: 10.1158/1078-0432.CCR-17-1439).
Tumor mutation burdens can predict response to checkpoint inhibitors, but they are usually assessed by tissue biopsy, which is costly and invasive. The findings suggest that blood tests could replace tissue biopsies to green-light immune checkpoint inhibitor treatment.
“Our current results may be clinically exploitable. ... Liquid biopsies that assess blood-derived ctDNA are noninvasive, easily acquired, and inexpensive. The ctDNA derived from blood may also represent shed DNA from multiple metastatic sites, whereas tissue genomics reflects only the piece of tissue removed,” said investigators led by Yulian Khagi, MD, a hematology-oncology fellow at the university.
In a press statement, Dr. Khagi said “If verified by further studies, clinicians will be able to utilize the ... results of this simple blood test to make determinations about whether to use checkpoint inhibitor–based immune therapy in a variety of tumor types.”
The 69 patients were a median of 56 years old, and 43 (62.3%) were men. Melanoma, lung cancer, and head and neck cancer were the most common malignancies. The majority of patients had anti–PD-1 or PD-L1 monotherapy.
For most patients, blood samples were drawn a month or 2 before treatment. Next-generation sequencing (Guardant360) was done on ctDNA to detect alterations in cancer genes. Of the 69 patients, 20 (29%) had more than three variants of unknown significance (VUS); the rest had three or fewer.
The median overall survival was 15.3 months from the start of immunotherapy. For patients with three or fewer VUS, median overall survival was 10.72 months; for patients with more, median overall survival could not be calculated because more than half were alive at the study’s conclusion.
Median progression-fee survival was 2.07 months with three or fewer VUS, versus 3.84 months with more. The findings were statistically significant.
Similar results were found when all genomic alterations, not just VUS, were examined and dichotomized as six or more versus fewer than six.
“The number of genes assayed in our ctDNA analysis was only between 54 and 70. Unlike targeted NGS [next-generation sequencing] of tumor tissue, which often tests for hundreds of genes and allows a relatively accurate estimate of total mutational burden, targeted NGS of plasma ctDNA provides only a limited snapshot of the cancer genome. More extensive ctDNA gene panels merit investigation to determine if they increase the correlative value of our findings,” the investigators said.
The work was funded by the Joan and Irwin Jacobs Fund and the National Cancer Institute. Dr. Khagi had no industry disclosures. Three authors reported financial ties to a number of companies, including Boehringer, Merck, Guardant, and Pfizer. The senior author has ownership interests in CureMatch.
FROM CLINICAL CANCER RESEARCH
Key clinical point:
Major finding: The overall response rate to immune checkpoint inhibitors was 45% among cancer patients who had more than three variants of unknown significance in their circulating tumor DNA; among those with three or fewer, the response rate was 15%.
Data source: Review of 69 cancer patients.
Disclosures: The work was funded by the Joan and Irwin Jacobs Fund and the National Cancer Institute. Three investigators reported financial ties to a number of companies, including Boehringer, Merck, Guardant, and Pfizer. The senior author has ownership interests in CureMatch.
Nocturia linked to hypertension, diuretic use in community-based study of black men
SAN FRANCISCO – Nocturia is a sign of uncontrolled hypertension and also is associated with diuretic use in middle-aged black men, according to a study conducted at 53 barbershops in and around Los Angeles.
In the study, investigators averaged the last three of five automated blood pressure readings in 1,748 black men aged 35-49 years old and asked them about symptoms of nocturia – defined in the study as getting up two or more times per night to urinate – and about what blood pressure medications they were taking, if any.
Men with untreated hypertension – defined as at or above 135/85 mm Hg – were 34% more likely to report nocturia than were men who were normotensive.
However, “what really grabbed our attention was the treated group,” lead investigator Ronald Victor, MD said at the joint scientific sessions of the AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The highest risk of nocturia, more than three times the risk of normotensive men, was among men treated with a diuretic who still had elevated blood pressure readings in the barbershop. Their risk was about 2.5 times greater in men who were treated but uncontrolled and were not on a diuretic, said Dr. Victor, director of the hypertension center at Cedars-Sinai Medical Center, Los Angeles.
Among men treated and controlled down to a systolic blood pressure of almost 120 mm Hg, those with a diuretic included in their regimen had about twice the risk of nocturia as did normotensive men; those controlled without a diuretic had no elevated risk of nocturia. The results were statistically significant and were adjusted for nocturia confounders, including diabetes, body mass index, sleep apnea, and an enlarged prostate.
“Nocturia is far more likely when hypertension is inadequately treated,” especially with a diuretic, than when untreated, Dr. Victor said. “The data suggest that nocturia may be a side effect of blood pressure drugs unless strict blood pressure control is achieved. Appropriate treatment of blood pressure without a diuretic may be really beneficial in terms of reducing nocturia.”
Not all the data on the specific medications the men in the study were taking were available, but the most common antihypertensive prescribed for them was short-acting, low-dose hydrochlorothiazide, he noted.
It has been shown that hydrochlorothiazide wears off in the evening when dosed in the morning, so blood pressure might appear to be well-controlled in the daytime, but patients become hypertensive at night, leading to pressure natriuresis and nocturia. “This might [help] explain our data,” Dr. Victor said, noting that longer-acting, more potent diuretics, such as chlorthalidone, might reduce the risk.
The team plans further work to see if tighter nighttime blood pressure control reduces nocturia and improves sleep. Maybe, he noted, “if you take your blood pressure meds correctly, you sleep better. That would be a fantastic public health message; we’ll see.”
Middle-aged black men are underrepresented in hypertension research, in part because of a mistrust of doctors and medical institutions. Enrolling black men in barbershops seemed a good way to address the problem; barbers are trusted and respected members of the community, and the shops themselves are warm and relaxed, which is why hypertension was defined in the study a bit lower than the usual 140/90 mm Hg, Dr. Victor commented.
A total of 45% of the men were hypertensive; only 16% were controlled on medication. Nocturia prevalence was higher than expected in the general population, at about 29% overall, and ranged from 24% in normotensive men to 50% in men whose hypertension was treated but uncontrolled.
Average blood pressures were 120/71 mm Hg in the normotensive men; 143/87 mm Hg in untreated hypertensive men; and 148/91 mm Hg in treated but uncontrolled men. The mean age in the study was 43 years. “We capped it at 49 because after that, nocturia is so prevalent, and dominated by prostate disease,” Dr. Victor said.
The investigators had no disclosures. The National Institutes of Health funded the work.
SAN FRANCISCO – Nocturia is a sign of uncontrolled hypertension and also is associated with diuretic use in middle-aged black men, according to a study conducted at 53 barbershops in and around Los Angeles.
In the study, investigators averaged the last three of five automated blood pressure readings in 1,748 black men aged 35-49 years old and asked them about symptoms of nocturia – defined in the study as getting up two or more times per night to urinate – and about what blood pressure medications they were taking, if any.
Men with untreated hypertension – defined as at or above 135/85 mm Hg – were 34% more likely to report nocturia than were men who were normotensive.
However, “what really grabbed our attention was the treated group,” lead investigator Ronald Victor, MD said at the joint scientific sessions of the AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The highest risk of nocturia, more than three times the risk of normotensive men, was among men treated with a diuretic who still had elevated blood pressure readings in the barbershop. Their risk was about 2.5 times greater in men who were treated but uncontrolled and were not on a diuretic, said Dr. Victor, director of the hypertension center at Cedars-Sinai Medical Center, Los Angeles.
Among men treated and controlled down to a systolic blood pressure of almost 120 mm Hg, those with a diuretic included in their regimen had about twice the risk of nocturia as did normotensive men; those controlled without a diuretic had no elevated risk of nocturia. The results were statistically significant and were adjusted for nocturia confounders, including diabetes, body mass index, sleep apnea, and an enlarged prostate.
“Nocturia is far more likely when hypertension is inadequately treated,” especially with a diuretic, than when untreated, Dr. Victor said. “The data suggest that nocturia may be a side effect of blood pressure drugs unless strict blood pressure control is achieved. Appropriate treatment of blood pressure without a diuretic may be really beneficial in terms of reducing nocturia.”
Not all the data on the specific medications the men in the study were taking were available, but the most common antihypertensive prescribed for them was short-acting, low-dose hydrochlorothiazide, he noted.
It has been shown that hydrochlorothiazide wears off in the evening when dosed in the morning, so blood pressure might appear to be well-controlled in the daytime, but patients become hypertensive at night, leading to pressure natriuresis and nocturia. “This might [help] explain our data,” Dr. Victor said, noting that longer-acting, more potent diuretics, such as chlorthalidone, might reduce the risk.
The team plans further work to see if tighter nighttime blood pressure control reduces nocturia and improves sleep. Maybe, he noted, “if you take your blood pressure meds correctly, you sleep better. That would be a fantastic public health message; we’ll see.”
Middle-aged black men are underrepresented in hypertension research, in part because of a mistrust of doctors and medical institutions. Enrolling black men in barbershops seemed a good way to address the problem; barbers are trusted and respected members of the community, and the shops themselves are warm and relaxed, which is why hypertension was defined in the study a bit lower than the usual 140/90 mm Hg, Dr. Victor commented.
A total of 45% of the men were hypertensive; only 16% were controlled on medication. Nocturia prevalence was higher than expected in the general population, at about 29% overall, and ranged from 24% in normotensive men to 50% in men whose hypertension was treated but uncontrolled.
Average blood pressures were 120/71 mm Hg in the normotensive men; 143/87 mm Hg in untreated hypertensive men; and 148/91 mm Hg in treated but uncontrolled men. The mean age in the study was 43 years. “We capped it at 49 because after that, nocturia is so prevalent, and dominated by prostate disease,” Dr. Victor said.
The investigators had no disclosures. The National Institutes of Health funded the work.
SAN FRANCISCO – Nocturia is a sign of uncontrolled hypertension and also is associated with diuretic use in middle-aged black men, according to a study conducted at 53 barbershops in and around Los Angeles.
In the study, investigators averaged the last three of five automated blood pressure readings in 1,748 black men aged 35-49 years old and asked them about symptoms of nocturia – defined in the study as getting up two or more times per night to urinate – and about what blood pressure medications they were taking, if any.
Men with untreated hypertension – defined as at or above 135/85 mm Hg – were 34% more likely to report nocturia than were men who were normotensive.
However, “what really grabbed our attention was the treated group,” lead investigator Ronald Victor, MD said at the joint scientific sessions of the AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The highest risk of nocturia, more than three times the risk of normotensive men, was among men treated with a diuretic who still had elevated blood pressure readings in the barbershop. Their risk was about 2.5 times greater in men who were treated but uncontrolled and were not on a diuretic, said Dr. Victor, director of the hypertension center at Cedars-Sinai Medical Center, Los Angeles.
Among men treated and controlled down to a systolic blood pressure of almost 120 mm Hg, those with a diuretic included in their regimen had about twice the risk of nocturia as did normotensive men; those controlled without a diuretic had no elevated risk of nocturia. The results were statistically significant and were adjusted for nocturia confounders, including diabetes, body mass index, sleep apnea, and an enlarged prostate.
“Nocturia is far more likely when hypertension is inadequately treated,” especially with a diuretic, than when untreated, Dr. Victor said. “The data suggest that nocturia may be a side effect of blood pressure drugs unless strict blood pressure control is achieved. Appropriate treatment of blood pressure without a diuretic may be really beneficial in terms of reducing nocturia.”
Not all the data on the specific medications the men in the study were taking were available, but the most common antihypertensive prescribed for them was short-acting, low-dose hydrochlorothiazide, he noted.
It has been shown that hydrochlorothiazide wears off in the evening when dosed in the morning, so blood pressure might appear to be well-controlled in the daytime, but patients become hypertensive at night, leading to pressure natriuresis and nocturia. “This might [help] explain our data,” Dr. Victor said, noting that longer-acting, more potent diuretics, such as chlorthalidone, might reduce the risk.
The team plans further work to see if tighter nighttime blood pressure control reduces nocturia and improves sleep. Maybe, he noted, “if you take your blood pressure meds correctly, you sleep better. That would be a fantastic public health message; we’ll see.”
Middle-aged black men are underrepresented in hypertension research, in part because of a mistrust of doctors and medical institutions. Enrolling black men in barbershops seemed a good way to address the problem; barbers are trusted and respected members of the community, and the shops themselves are warm and relaxed, which is why hypertension was defined in the study a bit lower than the usual 140/90 mm Hg, Dr. Victor commented.
A total of 45% of the men were hypertensive; only 16% were controlled on medication. Nocturia prevalence was higher than expected in the general population, at about 29% overall, and ranged from 24% in normotensive men to 50% in men whose hypertension was treated but uncontrolled.
Average blood pressures were 120/71 mm Hg in the normotensive men; 143/87 mm Hg in untreated hypertensive men; and 148/91 mm Hg in treated but uncontrolled men. The mean age in the study was 43 years. “We capped it at 49 because after that, nocturia is so prevalent, and dominated by prostate disease,” Dr. Victor said.
The investigators had no disclosures. The National Institutes of Health funded the work.
AT JOINT HYPERTENSION 2017
Key clinical point:
Major finding: The highest risk of nocturia, more than 3 times the risk of normotensive men, was among men treated with a diuretic who still had elevated blood pressure.
Data source: A community-based, cross-sectional study of 1,748 black men aged 35-49 years with blood pressures measured in 53 barbershops.
Disclosures: The investigators had no disclosures. The National Institutes of Health funded the work.
For treatment-resistant hypertension, drug urine screen advised
SAN FRANCISCO – The best way to make sure that patients are taking their blood pressure medications is to screen their urine for the drugs and metabolites, according to Robert Carey, MD, professor of medicine and dean emeritus of the University of Virginia, Charlottesville.
Dr. Carey shared his thoughts on the matter during his presentation on treatment resistant hypertension, at the joint scientific sessions of the AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
In up to about half the cases of apparent resistant hypertension, people simply aren’t taking their medications. Urine screening, “I believe, is the most accurate and best method of verifying adherence,” far more reliable than asking patients, or counting prescription refills, he said.
“I’m sort of a mad dog on documenting adherence because I think if we don’t document it and treat it, we will be stuck with a lot of inertia, and things won’t get better,” Dr. Carey said. He recommended speaking with patients, getting their permission to check urine levels, and reporting back results. It won’t make a difference in every case, but sometimes it will, especially if there’s an intervention to improve adherence, he noted.
Urine screening is available in most teaching hospitals and in commercial labs. “I think we will be seeing more and more availability. It has been demonstrated to be cost effective,” he said.
If adherence isn’t a problem, obesity, high sodium intake, and other lifestyle issues should be addressed, as well as the use of drugs that can raise blood pressure, especially NSAIDS, contraceptives, and hormone replacement therapies.
A workup for secondary causes also is in order. About 20% of patients will have primary aldosteronism, so all patients should be screened. Renal parenchymal disease and renal vascular disease also are common. Renal artery stenosis usually can be managed medically and rarely requires stenting. “One might take the tack of nonscreening until there’s a reduction in renal function or blood pressure goes way out of control,” Dr. Carey said.
Pheochromocytoma and Cushing’s syndrome are rare causes. Obstructive sleep apnea also is on the list “but I’m not sure it should be there. For one thing, CPAP [continuous positive airway pressure] only lowers blood pressure 1 or 2 mm. Secondly, CPAP does not prevent cardiovascular disease events in patients with moderate to severe sleep apnea and established cardiovascular risk,” he said.
If there’s no secondary cause that can be addressed, “the first thing to do is check the diuretic, and substitute in a long-acting, thiazide-like diuretic, either chlorthalidone or indapamide.” They lower blood pressure more effectively than do the thiazide diuretics, such as chlorothiazide and hydrochlorothiazide. They also provide better protection against cardiovascular events. “Once you make that substitution, you need to add a mineralocorticoid receptor antagonist, spironolactone or eplerenone. We have excellent data for both [classes of] diuretics to be added,” Dr. Carey said.
“Once we get beyond that point, we have to search the literature, and generally, we’ll come up with a goose egg in terms of randomized clinical trials. Another step is to add a beta-blocker or a vasodilating beta-blocker, [but] you would need to know precisely the mechanism of vasodilation,” he noted. After that, “you could add hydralazine or minoxidil,” a more potent vasodilator, but they have to be given with a beta-blocker and diuretic. If those approaches fail, “consider referring to a hypertension specialist,” he said.
Dr. Carey did not report any industry ties.
SAN FRANCISCO – The best way to make sure that patients are taking their blood pressure medications is to screen their urine for the drugs and metabolites, according to Robert Carey, MD, professor of medicine and dean emeritus of the University of Virginia, Charlottesville.
Dr. Carey shared his thoughts on the matter during his presentation on treatment resistant hypertension, at the joint scientific sessions of the AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
In up to about half the cases of apparent resistant hypertension, people simply aren’t taking their medications. Urine screening, “I believe, is the most accurate and best method of verifying adherence,” far more reliable than asking patients, or counting prescription refills, he said.
“I’m sort of a mad dog on documenting adherence because I think if we don’t document it and treat it, we will be stuck with a lot of inertia, and things won’t get better,” Dr. Carey said. He recommended speaking with patients, getting their permission to check urine levels, and reporting back results. It won’t make a difference in every case, but sometimes it will, especially if there’s an intervention to improve adherence, he noted.
Urine screening is available in most teaching hospitals and in commercial labs. “I think we will be seeing more and more availability. It has been demonstrated to be cost effective,” he said.
If adherence isn’t a problem, obesity, high sodium intake, and other lifestyle issues should be addressed, as well as the use of drugs that can raise blood pressure, especially NSAIDS, contraceptives, and hormone replacement therapies.
A workup for secondary causes also is in order. About 20% of patients will have primary aldosteronism, so all patients should be screened. Renal parenchymal disease and renal vascular disease also are common. Renal artery stenosis usually can be managed medically and rarely requires stenting. “One might take the tack of nonscreening until there’s a reduction in renal function or blood pressure goes way out of control,” Dr. Carey said.
Pheochromocytoma and Cushing’s syndrome are rare causes. Obstructive sleep apnea also is on the list “but I’m not sure it should be there. For one thing, CPAP [continuous positive airway pressure] only lowers blood pressure 1 or 2 mm. Secondly, CPAP does not prevent cardiovascular disease events in patients with moderate to severe sleep apnea and established cardiovascular risk,” he said.
If there’s no secondary cause that can be addressed, “the first thing to do is check the diuretic, and substitute in a long-acting, thiazide-like diuretic, either chlorthalidone or indapamide.” They lower blood pressure more effectively than do the thiazide diuretics, such as chlorothiazide and hydrochlorothiazide. They also provide better protection against cardiovascular events. “Once you make that substitution, you need to add a mineralocorticoid receptor antagonist, spironolactone or eplerenone. We have excellent data for both [classes of] diuretics to be added,” Dr. Carey said.
“Once we get beyond that point, we have to search the literature, and generally, we’ll come up with a goose egg in terms of randomized clinical trials. Another step is to add a beta-blocker or a vasodilating beta-blocker, [but] you would need to know precisely the mechanism of vasodilation,” he noted. After that, “you could add hydralazine or minoxidil,” a more potent vasodilator, but they have to be given with a beta-blocker and diuretic. If those approaches fail, “consider referring to a hypertension specialist,” he said.
Dr. Carey did not report any industry ties.
SAN FRANCISCO – The best way to make sure that patients are taking their blood pressure medications is to screen their urine for the drugs and metabolites, according to Robert Carey, MD, professor of medicine and dean emeritus of the University of Virginia, Charlottesville.
Dr. Carey shared his thoughts on the matter during his presentation on treatment resistant hypertension, at the joint scientific sessions of the AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
In up to about half the cases of apparent resistant hypertension, people simply aren’t taking their medications. Urine screening, “I believe, is the most accurate and best method of verifying adherence,” far more reliable than asking patients, or counting prescription refills, he said.
“I’m sort of a mad dog on documenting adherence because I think if we don’t document it and treat it, we will be stuck with a lot of inertia, and things won’t get better,” Dr. Carey said. He recommended speaking with patients, getting their permission to check urine levels, and reporting back results. It won’t make a difference in every case, but sometimes it will, especially if there’s an intervention to improve adherence, he noted.
Urine screening is available in most teaching hospitals and in commercial labs. “I think we will be seeing more and more availability. It has been demonstrated to be cost effective,” he said.
If adherence isn’t a problem, obesity, high sodium intake, and other lifestyle issues should be addressed, as well as the use of drugs that can raise blood pressure, especially NSAIDS, contraceptives, and hormone replacement therapies.
A workup for secondary causes also is in order. About 20% of patients will have primary aldosteronism, so all patients should be screened. Renal parenchymal disease and renal vascular disease also are common. Renal artery stenosis usually can be managed medically and rarely requires stenting. “One might take the tack of nonscreening until there’s a reduction in renal function or blood pressure goes way out of control,” Dr. Carey said.
Pheochromocytoma and Cushing’s syndrome are rare causes. Obstructive sleep apnea also is on the list “but I’m not sure it should be there. For one thing, CPAP [continuous positive airway pressure] only lowers blood pressure 1 or 2 mm. Secondly, CPAP does not prevent cardiovascular disease events in patients with moderate to severe sleep apnea and established cardiovascular risk,” he said.
If there’s no secondary cause that can be addressed, “the first thing to do is check the diuretic, and substitute in a long-acting, thiazide-like diuretic, either chlorthalidone or indapamide.” They lower blood pressure more effectively than do the thiazide diuretics, such as chlorothiazide and hydrochlorothiazide. They also provide better protection against cardiovascular events. “Once you make that substitution, you need to add a mineralocorticoid receptor antagonist, spironolactone or eplerenone. We have excellent data for both [classes of] diuretics to be added,” Dr. Carey said.
“Once we get beyond that point, we have to search the literature, and generally, we’ll come up with a goose egg in terms of randomized clinical trials. Another step is to add a beta-blocker or a vasodilating beta-blocker, [but] you would need to know precisely the mechanism of vasodilation,” he noted. After that, “you could add hydralazine or minoxidil,” a more potent vasodilator, but they have to be given with a beta-blocker and diuretic. If those approaches fail, “consider referring to a hypertension specialist,” he said.
Dr. Carey did not report any industry ties.
EXPERT ANALYSIS FROM JOINT HYPERTENSION 2017
Pediatric hypertension diagnosis requires repeat ambulatory pressure session
SAN FRANCISCO – Pediatric ambulatory blood pressure monitoring (ABPM) is not stable over time and should be repeated before hypertension is diagnosed, according to an investigation of 102 children at Seattle Children’s Hospital.
Most of the children in the study had two 24-hour ABPM sessions at least 6 months apart (median, 1.5 years apart); a few children had three or four sessions. The children were aged 14.6 years, on average, at the first session, and had lifestyle counseling during the study period, but were not on blood pressure medications. Children were considered hypertensive if their average 24-hour readings were above the 95th percentile for sex and height until age 17 years, when they were considered hypertensive with readings of 140/85 mm Hg awake and 120/70 mm Hg asleep. Children with secondary causes of hypertension were excluded from the study.
Half of the children had a change in their ABPM classification from their first to their last session. Among 19 children with an initially normal reading, five progressed to prehypertension, and five to overt hypertension. Among 37 children initially classified as prehypertensive, 10 reverted to normal, and 9 progressed to hypertension. Among 46 children who were hypertensive on the first ABPM, 4 reverted to normal, and 17 improved to prehypertension. Among the 20 children with initially blunted nocturnal dipping, 9 normalized and 1 progressed to reverse dipping.
“These findings support greater use of repeat ABPM. It is possible that children with initially normal ABP may progress to hypertension or prehypertension, or that those with initial prehypertension or hypertension may be normal on repeat,” lead investigator Coral Hanevold, MD, said at the joint scientific sessions of the AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
ABPM “is a great tool, but I think we have to realize it has some limitations,” she added. One limitation is that the patterns may not be that stable, and “before we go in and label people, it’s a good idea not to rely on just one session of monitoring,” added Dr. Hanevold, a clinical professor of pediatrics and director of the hypertension program at Seattle Children’s Hospital.
“Kids could be having a bad day the first time and get labeled hypertensive when maybe they’re not. Maybe they will improve,” she said.
The investigators plan to combine their data with a similar dataset from the Children’s Hospital of Pittsburgh. The goal is to be able to predict when white coat and prehypertension will progress to hypertension. Part of the work will involve putting a finer tooth on the broad ABPM categories of normal, prehypertensive, and hypertensive. It’s possible, for instance, that prehypertensive children who are initially closer to the threshold of hypertension will be more likely than other prehypertensive children to actually develop it.
“Our question is what’s going to happen long term. The telling thing is what’s the kid going to be like in 5 years, 10 years,” data that are not available, Dr. Hanevold said.
There was no external funding for the work, and the investigators had no disclosures.
SAN FRANCISCO – Pediatric ambulatory blood pressure monitoring (ABPM) is not stable over time and should be repeated before hypertension is diagnosed, according to an investigation of 102 children at Seattle Children’s Hospital.
Most of the children in the study had two 24-hour ABPM sessions at least 6 months apart (median, 1.5 years apart); a few children had three or four sessions. The children were aged 14.6 years, on average, at the first session, and had lifestyle counseling during the study period, but were not on blood pressure medications. Children were considered hypertensive if their average 24-hour readings were above the 95th percentile for sex and height until age 17 years, when they were considered hypertensive with readings of 140/85 mm Hg awake and 120/70 mm Hg asleep. Children with secondary causes of hypertension were excluded from the study.
Half of the children had a change in their ABPM classification from their first to their last session. Among 19 children with an initially normal reading, five progressed to prehypertension, and five to overt hypertension. Among 37 children initially classified as prehypertensive, 10 reverted to normal, and 9 progressed to hypertension. Among 46 children who were hypertensive on the first ABPM, 4 reverted to normal, and 17 improved to prehypertension. Among the 20 children with initially blunted nocturnal dipping, 9 normalized and 1 progressed to reverse dipping.
“These findings support greater use of repeat ABPM. It is possible that children with initially normal ABP may progress to hypertension or prehypertension, or that those with initial prehypertension or hypertension may be normal on repeat,” lead investigator Coral Hanevold, MD, said at the joint scientific sessions of the AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
ABPM “is a great tool, but I think we have to realize it has some limitations,” she added. One limitation is that the patterns may not be that stable, and “before we go in and label people, it’s a good idea not to rely on just one session of monitoring,” added Dr. Hanevold, a clinical professor of pediatrics and director of the hypertension program at Seattle Children’s Hospital.
“Kids could be having a bad day the first time and get labeled hypertensive when maybe they’re not. Maybe they will improve,” she said.
The investigators plan to combine their data with a similar dataset from the Children’s Hospital of Pittsburgh. The goal is to be able to predict when white coat and prehypertension will progress to hypertension. Part of the work will involve putting a finer tooth on the broad ABPM categories of normal, prehypertensive, and hypertensive. It’s possible, for instance, that prehypertensive children who are initially closer to the threshold of hypertension will be more likely than other prehypertensive children to actually develop it.
“Our question is what’s going to happen long term. The telling thing is what’s the kid going to be like in 5 years, 10 years,” data that are not available, Dr. Hanevold said.
There was no external funding for the work, and the investigators had no disclosures.
SAN FRANCISCO – Pediatric ambulatory blood pressure monitoring (ABPM) is not stable over time and should be repeated before hypertension is diagnosed, according to an investigation of 102 children at Seattle Children’s Hospital.
Most of the children in the study had two 24-hour ABPM sessions at least 6 months apart (median, 1.5 years apart); a few children had three or four sessions. The children were aged 14.6 years, on average, at the first session, and had lifestyle counseling during the study period, but were not on blood pressure medications. Children were considered hypertensive if their average 24-hour readings were above the 95th percentile for sex and height until age 17 years, when they were considered hypertensive with readings of 140/85 mm Hg awake and 120/70 mm Hg asleep. Children with secondary causes of hypertension were excluded from the study.
Half of the children had a change in their ABPM classification from their first to their last session. Among 19 children with an initially normal reading, five progressed to prehypertension, and five to overt hypertension. Among 37 children initially classified as prehypertensive, 10 reverted to normal, and 9 progressed to hypertension. Among 46 children who were hypertensive on the first ABPM, 4 reverted to normal, and 17 improved to prehypertension. Among the 20 children with initially blunted nocturnal dipping, 9 normalized and 1 progressed to reverse dipping.
“These findings support greater use of repeat ABPM. It is possible that children with initially normal ABP may progress to hypertension or prehypertension, or that those with initial prehypertension or hypertension may be normal on repeat,” lead investigator Coral Hanevold, MD, said at the joint scientific sessions of the AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
ABPM “is a great tool, but I think we have to realize it has some limitations,” she added. One limitation is that the patterns may not be that stable, and “before we go in and label people, it’s a good idea not to rely on just one session of monitoring,” added Dr. Hanevold, a clinical professor of pediatrics and director of the hypertension program at Seattle Children’s Hospital.
“Kids could be having a bad day the first time and get labeled hypertensive when maybe they’re not. Maybe they will improve,” she said.
The investigators plan to combine their data with a similar dataset from the Children’s Hospital of Pittsburgh. The goal is to be able to predict when white coat and prehypertension will progress to hypertension. Part of the work will involve putting a finer tooth on the broad ABPM categories of normal, prehypertensive, and hypertensive. It’s possible, for instance, that prehypertensive children who are initially closer to the threshold of hypertension will be more likely than other prehypertensive children to actually develop it.
“Our question is what’s going to happen long term. The telling thing is what’s the kid going to be like in 5 years, 10 years,” data that are not available, Dr. Hanevold said.
There was no external funding for the work, and the investigators had no disclosures.
AT JOINT HYPERTENSION 2017
Key clinical point:
Major finding: Half of the children in a study had a change in their ABPM classification from the first to the last session.
Data source: Review of 102 children with at least two ABPM sessions 6 months apart.
Disclosures: There was no external funding for the work, and the investigators had no disclosures.
Transoral robotic surgery assessed for oral lesions
A single-arm study is being conducted at the Ohio State University Comprehensive Cancer Center, Columbus, to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the da Vinci Robotic Surgical System.
The study started in 2007, and the estimated completion date is December 2020. Investigators hope to enroll 360 adults.
Patients are scheduled for regular postop visits to assess quality of life and other matters. Those unable to return to Ohio State University are contacted by phone or provided with the questionnaire by mail.
A single-arm study is being conducted at the Ohio State University Comprehensive Cancer Center, Columbus, to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the da Vinci Robotic Surgical System.
The study started in 2007, and the estimated completion date is December 2020. Investigators hope to enroll 360 adults.
Patients are scheduled for regular postop visits to assess quality of life and other matters. Those unable to return to Ohio State University are contacted by phone or provided with the questionnaire by mail.
A single-arm study is being conducted at the Ohio State University Comprehensive Cancer Center, Columbus, to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the da Vinci Robotic Surgical System.
The study started in 2007, and the estimated completion date is December 2020. Investigators hope to enroll 360 adults.
Patients are scheduled for regular postop visits to assess quality of life and other matters. Those unable to return to Ohio State University are contacted by phone or provided with the questionnaire by mail.
How to lower blood pressure in real-world primary care clinics
SAN FRANCISCO – In just 6 months, a commonsense quality improvement program increased the rate of blood pressure control from 66% to 75% among 21,035 hypertensive patients at 16 primary care clinics in northwestern South Carolina.
The American Medical Association collaborated with the Care Coordination Institute in Greenville, S.C., to develop the program, dubbed “MAP,” which stands for measuring blood pressure accurately; acting rapidly to manage uncontrolled blood pressure; and partnering with patients to promote blood pressure self-management.
With the success in South Carolina, it’s likely the program will be rolled out to other parts of the country, Dr. Egan said at the joint scientific sessions of AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension
Twelve of the 16 practices had significant increases in BP control. In patients uncontrolled at baseline, mean BP fell from 149/85 mm Hg to 139/80 mm Hg. In controlled patients, BP fell about 10/5 mm Hg. The findings were statistically significant.
To reduce white coat hypertension and improve BP accuracy, patients who had an initial, attended BP at or above 140/90 mm Hg were put in a room by themselves for 5 minutes for three automated BP measurements, which were then averaged. Staff made sure patients were positioned properly and had the correctly sized cuff on their arm, among other measures. A program facilitator was onsite to help.
Patients who had BPs at or above 140/90 mm Hg when they were left alone were switched to drugs that have been proven to help. For white patients younger than 55 years, that meant a renin-angiotensin system blocker first and a calcium channel blocker second. For older African American patients, the calcium channel blocker came first. A diuretic was added if needed as a third step, and then spironolactone as a fourth. “That was basically the regimen in the absence of compelling indications for other agents,” Dr. Egan said.
Single-pill combinations were encouraged to help with compliance. The investigators also worked with nearby pharmacies to use generic drugs to keep costs low, and to ensure that patients could pick up all their prescriptions at one visit. Many of the patients had multiple chronic conditions and were on a half dozen or more drugs. Picking them all up at one pharmacy visit has been shown to improve adherence.
There was follow-up every 2 weeks for patients with stage 2 hypertension, at least by phone. Stage 1 patients had monthly follow-ups. Lifestyle changes were encouraged, as well as home BP monitoring. The clinics were given a few home monitors to send home with patients, and patients reported their results. If BP was elevated at home, patients were contacted and advised before their next visit.
They were also given a cookbook that matched the DASH diet with the southern palate. “We tried to make it taste good and not cost more,” Dr. Egan said. “It’s been quite popular for our patients who are willing to give it a try. It’s free on our website.”
With the intervention, “not only did [patients] take their new medications, but they also were probably taking previous medications more reliably,” he said.
It’s likely that the program reduced hypertension comorbidities, Dr. Egan noted, but there was no cost-benefit analysis.
There was no pharmaceutical industry funding. Dr. Egan disclosed research support from Boehringer.
SAN FRANCISCO – In just 6 months, a commonsense quality improvement program increased the rate of blood pressure control from 66% to 75% among 21,035 hypertensive patients at 16 primary care clinics in northwestern South Carolina.
The American Medical Association collaborated with the Care Coordination Institute in Greenville, S.C., to develop the program, dubbed “MAP,” which stands for measuring blood pressure accurately; acting rapidly to manage uncontrolled blood pressure; and partnering with patients to promote blood pressure self-management.
With the success in South Carolina, it’s likely the program will be rolled out to other parts of the country, Dr. Egan said at the joint scientific sessions of AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension
Twelve of the 16 practices had significant increases in BP control. In patients uncontrolled at baseline, mean BP fell from 149/85 mm Hg to 139/80 mm Hg. In controlled patients, BP fell about 10/5 mm Hg. The findings were statistically significant.
To reduce white coat hypertension and improve BP accuracy, patients who had an initial, attended BP at or above 140/90 mm Hg were put in a room by themselves for 5 minutes for three automated BP measurements, which were then averaged. Staff made sure patients were positioned properly and had the correctly sized cuff on their arm, among other measures. A program facilitator was onsite to help.
Patients who had BPs at or above 140/90 mm Hg when they were left alone were switched to drugs that have been proven to help. For white patients younger than 55 years, that meant a renin-angiotensin system blocker first and a calcium channel blocker second. For older African American patients, the calcium channel blocker came first. A diuretic was added if needed as a third step, and then spironolactone as a fourth. “That was basically the regimen in the absence of compelling indications for other agents,” Dr. Egan said.
Single-pill combinations were encouraged to help with compliance. The investigators also worked with nearby pharmacies to use generic drugs to keep costs low, and to ensure that patients could pick up all their prescriptions at one visit. Many of the patients had multiple chronic conditions and were on a half dozen or more drugs. Picking them all up at one pharmacy visit has been shown to improve adherence.
There was follow-up every 2 weeks for patients with stage 2 hypertension, at least by phone. Stage 1 patients had monthly follow-ups. Lifestyle changes were encouraged, as well as home BP monitoring. The clinics were given a few home monitors to send home with patients, and patients reported their results. If BP was elevated at home, patients were contacted and advised before their next visit.
They were also given a cookbook that matched the DASH diet with the southern palate. “We tried to make it taste good and not cost more,” Dr. Egan said. “It’s been quite popular for our patients who are willing to give it a try. It’s free on our website.”
With the intervention, “not only did [patients] take their new medications, but they also were probably taking previous medications more reliably,” he said.
It’s likely that the program reduced hypertension comorbidities, Dr. Egan noted, but there was no cost-benefit analysis.
There was no pharmaceutical industry funding. Dr. Egan disclosed research support from Boehringer.
SAN FRANCISCO – In just 6 months, a commonsense quality improvement program increased the rate of blood pressure control from 66% to 75% among 21,035 hypertensive patients at 16 primary care clinics in northwestern South Carolina.
The American Medical Association collaborated with the Care Coordination Institute in Greenville, S.C., to develop the program, dubbed “MAP,” which stands for measuring blood pressure accurately; acting rapidly to manage uncontrolled blood pressure; and partnering with patients to promote blood pressure self-management.
With the success in South Carolina, it’s likely the program will be rolled out to other parts of the country, Dr. Egan said at the joint scientific sessions of AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension
Twelve of the 16 practices had significant increases in BP control. In patients uncontrolled at baseline, mean BP fell from 149/85 mm Hg to 139/80 mm Hg. In controlled patients, BP fell about 10/5 mm Hg. The findings were statistically significant.
To reduce white coat hypertension and improve BP accuracy, patients who had an initial, attended BP at or above 140/90 mm Hg were put in a room by themselves for 5 minutes for three automated BP measurements, which were then averaged. Staff made sure patients were positioned properly and had the correctly sized cuff on their arm, among other measures. A program facilitator was onsite to help.
Patients who had BPs at or above 140/90 mm Hg when they were left alone were switched to drugs that have been proven to help. For white patients younger than 55 years, that meant a renin-angiotensin system blocker first and a calcium channel blocker second. For older African American patients, the calcium channel blocker came first. A diuretic was added if needed as a third step, and then spironolactone as a fourth. “That was basically the regimen in the absence of compelling indications for other agents,” Dr. Egan said.
Single-pill combinations were encouraged to help with compliance. The investigators also worked with nearby pharmacies to use generic drugs to keep costs low, and to ensure that patients could pick up all their prescriptions at one visit. Many of the patients had multiple chronic conditions and were on a half dozen or more drugs. Picking them all up at one pharmacy visit has been shown to improve adherence.
There was follow-up every 2 weeks for patients with stage 2 hypertension, at least by phone. Stage 1 patients had monthly follow-ups. Lifestyle changes were encouraged, as well as home BP monitoring. The clinics were given a few home monitors to send home with patients, and patients reported their results. If BP was elevated at home, patients were contacted and advised before their next visit.
They were also given a cookbook that matched the DASH diet with the southern palate. “We tried to make it taste good and not cost more,” Dr. Egan said. “It’s been quite popular for our patients who are willing to give it a try. It’s free on our website.”
With the intervention, “not only did [patients] take their new medications, but they also were probably taking previous medications more reliably,” he said.
It’s likely that the program reduced hypertension comorbidities, Dr. Egan noted, but there was no cost-benefit analysis.
There was no pharmaceutical industry funding. Dr. Egan disclosed research support from Boehringer.
AT JOINT HYPERTENSION 2017
Higher BP targets suggested for elderly, cognitively impaired
SAN FRANCISCO – Lowering blood pressure below 140/90 mm Hg might not be a good idea in the very elderly, especially if they have cognitive impairment, according to Philip Gorelick, MD.
“Lower blood pressure” in those patients “may be associated with worse cognitive outcomes,” he said at the joint scientific sessions of AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The problem is that higher pressures may be needed to maintain cerebral perfusion. It’s possible the very elderly have impaired cerebral autoregulation, especially if there’s a history of hypertension. A little extra pressure is needed to overcome increased cerebral vascular resistance.
“Cautious blood pressure–lowering with a target of about 150 mm Hg systolic, may be prudent,” said Dr. Gorelick, professor of translational science and molecular medicine at Michigan State University in Grand Rapids. Meanwhile, “for those without cognitive impairment and who have intact cerebral autoregulation, lower blood pressure targets may be beneficial to preserve cognition.
It’s become clear in recent years that cognitive decline is not a strictly neurologic issue, but rather related to cardiovascular health, at least in some people. Good blood pressure control in midlife, in particular, seems to be important for prevention.
“The same risk factors for atherosclerotic disease [are] risks for Alzheimer’s disease. Vascular risks play a role in cognitive impairment, including Alzheimer’s,” he said.
But the evidence is not clear for blood pressure lowering after the age of 80. Several studies have suggested that angiotensin receptor blockers and other hypertension medications reduce pathologic and clinical changes associated with Alzheimer’s. “However, there’s certainly a downside” to using them in the elderly. “Everything that glistens is not gold,” Dr. Gorelick said.
“There have been studies in older persons with mild cognitive deficits who are placed on antihypertensives, and they actually have lower brain volumes: The brain is shrinking, possibly at a faster rate. Other studies have suggested that people around 80 years of age may have greater cognitive decline with lower blood pressure,” he said.
For those older than 80 and patients with cognitive impairment, the usefulness of blood pressure–lowering for prevention of dementia has not been established. Relaxing the blood pressure control targets might prevent harm, he said.
“There’s going to be a window of opportunity where were are going to see some benefit” in using, for instance, ARBs to slow cognitive decline, but “we have to be smart enough to find the right patients and the right window. We’re not there yet,” he said.
Dr. Gorelick is a consultant for Bayer, Novartis, and Amgen.
SAN FRANCISCO – Lowering blood pressure below 140/90 mm Hg might not be a good idea in the very elderly, especially if they have cognitive impairment, according to Philip Gorelick, MD.
“Lower blood pressure” in those patients “may be associated with worse cognitive outcomes,” he said at the joint scientific sessions of AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The problem is that higher pressures may be needed to maintain cerebral perfusion. It’s possible the very elderly have impaired cerebral autoregulation, especially if there’s a history of hypertension. A little extra pressure is needed to overcome increased cerebral vascular resistance.
“Cautious blood pressure–lowering with a target of about 150 mm Hg systolic, may be prudent,” said Dr. Gorelick, professor of translational science and molecular medicine at Michigan State University in Grand Rapids. Meanwhile, “for those without cognitive impairment and who have intact cerebral autoregulation, lower blood pressure targets may be beneficial to preserve cognition.
It’s become clear in recent years that cognitive decline is not a strictly neurologic issue, but rather related to cardiovascular health, at least in some people. Good blood pressure control in midlife, in particular, seems to be important for prevention.
“The same risk factors for atherosclerotic disease [are] risks for Alzheimer’s disease. Vascular risks play a role in cognitive impairment, including Alzheimer’s,” he said.
But the evidence is not clear for blood pressure lowering after the age of 80. Several studies have suggested that angiotensin receptor blockers and other hypertension medications reduce pathologic and clinical changes associated with Alzheimer’s. “However, there’s certainly a downside” to using them in the elderly. “Everything that glistens is not gold,” Dr. Gorelick said.
“There have been studies in older persons with mild cognitive deficits who are placed on antihypertensives, and they actually have lower brain volumes: The brain is shrinking, possibly at a faster rate. Other studies have suggested that people around 80 years of age may have greater cognitive decline with lower blood pressure,” he said.
For those older than 80 and patients with cognitive impairment, the usefulness of blood pressure–lowering for prevention of dementia has not been established. Relaxing the blood pressure control targets might prevent harm, he said.
“There’s going to be a window of opportunity where were are going to see some benefit” in using, for instance, ARBs to slow cognitive decline, but “we have to be smart enough to find the right patients and the right window. We’re not there yet,” he said.
Dr. Gorelick is a consultant for Bayer, Novartis, and Amgen.
SAN FRANCISCO – Lowering blood pressure below 140/90 mm Hg might not be a good idea in the very elderly, especially if they have cognitive impairment, according to Philip Gorelick, MD.
“Lower blood pressure” in those patients “may be associated with worse cognitive outcomes,” he said at the joint scientific sessions of AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The problem is that higher pressures may be needed to maintain cerebral perfusion. It’s possible the very elderly have impaired cerebral autoregulation, especially if there’s a history of hypertension. A little extra pressure is needed to overcome increased cerebral vascular resistance.
“Cautious blood pressure–lowering with a target of about 150 mm Hg systolic, may be prudent,” said Dr. Gorelick, professor of translational science and molecular medicine at Michigan State University in Grand Rapids. Meanwhile, “for those without cognitive impairment and who have intact cerebral autoregulation, lower blood pressure targets may be beneficial to preserve cognition.
It’s become clear in recent years that cognitive decline is not a strictly neurologic issue, but rather related to cardiovascular health, at least in some people. Good blood pressure control in midlife, in particular, seems to be important for prevention.
“The same risk factors for atherosclerotic disease [are] risks for Alzheimer’s disease. Vascular risks play a role in cognitive impairment, including Alzheimer’s,” he said.
But the evidence is not clear for blood pressure lowering after the age of 80. Several studies have suggested that angiotensin receptor blockers and other hypertension medications reduce pathologic and clinical changes associated with Alzheimer’s. “However, there’s certainly a downside” to using them in the elderly. “Everything that glistens is not gold,” Dr. Gorelick said.
“There have been studies in older persons with mild cognitive deficits who are placed on antihypertensives, and they actually have lower brain volumes: The brain is shrinking, possibly at a faster rate. Other studies have suggested that people around 80 years of age may have greater cognitive decline with lower blood pressure,” he said.
For those older than 80 and patients with cognitive impairment, the usefulness of blood pressure–lowering for prevention of dementia has not been established. Relaxing the blood pressure control targets might prevent harm, he said.
“There’s going to be a window of opportunity where were are going to see some benefit” in using, for instance, ARBs to slow cognitive decline, but “we have to be smart enough to find the right patients and the right window. We’re not there yet,” he said.
Dr. Gorelick is a consultant for Bayer, Novartis, and Amgen.
EXPERT ANALYSIS FROM Joint Hypertension 2017
Medtronic, others push forward with HTN renal artery denervation
SAN FRANCISCO – Hypertensive patients averaged about a 10-mm Hg drop in 24-hour ambulatory systolic blood pressure and about a 12-mm Hg drop in office systolic blood pressure, 2 years after treatment with Medtronic’s new Symplicity Spyral renal artery denervation catheter, according to a review of the company’s renal artery denervation registry.
No major safety issues were reported, but there was no reduction from baseline in the number of antihypertensive drugs that patients were prescribed, which averaged more than four.
The company withdrew the Flex catheter from development after a large, randomized U.S. trial found no benefit over a sham procedure for resistant hypertension (N Engl J Med. 2014 Apr 10;370[15]:1393-401). “In the future, everything will be built around the Spyral catheter,” said Michael Weber, MD, a Medtronic investigator and a professor of medicine at State University of New York, Brooklyn. He presented the registry findings at the joint scientific sessions of AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The Spyral, he said, has two key advantages over the Flex. The Flex had just a single electrode, so operators had to rotate the tip into four quadrants to fully denervate renal arteries, “a tricky business at the best of times and very often not successfully achieved.” Inadequate ablation might have contributed to the trial failure, Dr. Weber said.
The Spyral catheter, on the other hand, has four electrodes placed radially around a spiral catheter, so all four quadrants can be ablated at once, without undue gymnastics. The Spyral can also enter the smaller branches of the main renal arteries, which might allow for more complete denervation, he said.
“We all anticipate better results with the Spyral, but let’s be cautious. We need more data and obviously data from controlled clinical trials. There’s a lot to be learned yet about this whole procedure,” Dr. Weber said.
Medtronic is planning a large trial of its new device following the recent publication of a successful proof-of-concept study that pitted the Spyral in 38 hypertensives against a sham procedure in 42. The Spyral group had a 5 mm Hg greater reduction in systolic ambulatory blood pressure at 3 months, among other findings. To avoid confounding, investigators took patients off their blood pressure medications during the study (Lancet. 2017 Aug 25. pii: S0140-6736(17)32281-X. doi: 10.1016/S0140-6736[17]32281-X).
Other companies are pushing forward with renal artery denervation, as well; Boston Scientific has its own four-quadrant ablation catheter – Vessix – in the pipeline.
In Medtronic’s denervation registry, office systolic blood pressure reductions were a bit larger at 2 years for the older Flex catheter than with the newer Spyral, 15.7 versus 12.0 mm Hg from a baseline of about 170 mm Hg in both groups. Spyral had a slight edge on 24-hour ambulatory systolic blood pressure at 2 years, with an average reduction of 10.4 versus 8.7 mm Hg from a mean baseline of about 155 mm Hg.
For both devices, “when you look at results patient-by-patient, they are dramatically all over the place, including a significant number of patients whose pressures actually increase. I have to assume that it’s patients” who stop taking their medications after the procedure. On the flip side, “I suspect some of our terrific results are because people finally get a touch of religion after the intervention and start taking their drugs for the first time,” Dr. Weber said.
So far, only a handful of Spyral patients have had ablations in renal artery branches. “It seems to have some benefit as judged by office pressure, but the numbers are small, so it’s premature to draw any conclusions,” he said.
Registry patients were in their early 60s, on average, at baseline, and there were more men than women. As with Spyral, Flex patients had no decrease in hypertension prescriptions over time and averaged more than four. “We have not seen many miracle cures in the sense of patients suddenly requiring no drugs at all,” Dr. Weber said.
The procedure seems safe, according to the registry. “There’s nothing to suggest the use of these catheters in the renal arteries causes any sort of acute or later-appearing major renal artery compromise.” With the Flex, less than 1% of patients required renal artery reintervention, which was possibly related to ablation trauma stenosis, “but it’s something to keep on our list of things to look for,” Dr. Weber said.
When asked if the registry fully captures adverse events, Dr. Weber said that “I suspect once [Spyral] goes to market, assuming it does go to market, there will be far more rigorous reporting requirements.”
He reported receiving travel funding, as well as consulting and lecture fees, from Medtronic and Boston Scientific, among other companies.
We need to see randomized trials. This technology looks encouraging, but there’s nothing definitive yet in terms of direct applicability. The initial proof of concept study suggested it does lower blood pressure – but not by a lot. I think it’s a long way from common clinical use, but it’s reasonable to keep looking at it.
We need to see randomized trials. This technology looks encouraging, but there’s nothing definitive yet in terms of direct applicability. The initial proof of concept study suggested it does lower blood pressure – but not by a lot. I think it’s a long way from common clinical use, but it’s reasonable to keep looking at it.
We need to see randomized trials. This technology looks encouraging, but there’s nothing definitive yet in terms of direct applicability. The initial proof of concept study suggested it does lower blood pressure – but not by a lot. I think it’s a long way from common clinical use, but it’s reasonable to keep looking at it.
SAN FRANCISCO – Hypertensive patients averaged about a 10-mm Hg drop in 24-hour ambulatory systolic blood pressure and about a 12-mm Hg drop in office systolic blood pressure, 2 years after treatment with Medtronic’s new Symplicity Spyral renal artery denervation catheter, according to a review of the company’s renal artery denervation registry.
No major safety issues were reported, but there was no reduction from baseline in the number of antihypertensive drugs that patients were prescribed, which averaged more than four.
The company withdrew the Flex catheter from development after a large, randomized U.S. trial found no benefit over a sham procedure for resistant hypertension (N Engl J Med. 2014 Apr 10;370[15]:1393-401). “In the future, everything will be built around the Spyral catheter,” said Michael Weber, MD, a Medtronic investigator and a professor of medicine at State University of New York, Brooklyn. He presented the registry findings at the joint scientific sessions of AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The Spyral, he said, has two key advantages over the Flex. The Flex had just a single electrode, so operators had to rotate the tip into four quadrants to fully denervate renal arteries, “a tricky business at the best of times and very often not successfully achieved.” Inadequate ablation might have contributed to the trial failure, Dr. Weber said.
The Spyral catheter, on the other hand, has four electrodes placed radially around a spiral catheter, so all four quadrants can be ablated at once, without undue gymnastics. The Spyral can also enter the smaller branches of the main renal arteries, which might allow for more complete denervation, he said.
“We all anticipate better results with the Spyral, but let’s be cautious. We need more data and obviously data from controlled clinical trials. There’s a lot to be learned yet about this whole procedure,” Dr. Weber said.
Medtronic is planning a large trial of its new device following the recent publication of a successful proof-of-concept study that pitted the Spyral in 38 hypertensives against a sham procedure in 42. The Spyral group had a 5 mm Hg greater reduction in systolic ambulatory blood pressure at 3 months, among other findings. To avoid confounding, investigators took patients off their blood pressure medications during the study (Lancet. 2017 Aug 25. pii: S0140-6736(17)32281-X. doi: 10.1016/S0140-6736[17]32281-X).
Other companies are pushing forward with renal artery denervation, as well; Boston Scientific has its own four-quadrant ablation catheter – Vessix – in the pipeline.
In Medtronic’s denervation registry, office systolic blood pressure reductions were a bit larger at 2 years for the older Flex catheter than with the newer Spyral, 15.7 versus 12.0 mm Hg from a baseline of about 170 mm Hg in both groups. Spyral had a slight edge on 24-hour ambulatory systolic blood pressure at 2 years, with an average reduction of 10.4 versus 8.7 mm Hg from a mean baseline of about 155 mm Hg.
For both devices, “when you look at results patient-by-patient, they are dramatically all over the place, including a significant number of patients whose pressures actually increase. I have to assume that it’s patients” who stop taking their medications after the procedure. On the flip side, “I suspect some of our terrific results are because people finally get a touch of religion after the intervention and start taking their drugs for the first time,” Dr. Weber said.
So far, only a handful of Spyral patients have had ablations in renal artery branches. “It seems to have some benefit as judged by office pressure, but the numbers are small, so it’s premature to draw any conclusions,” he said.
Registry patients were in their early 60s, on average, at baseline, and there were more men than women. As with Spyral, Flex patients had no decrease in hypertension prescriptions over time and averaged more than four. “We have not seen many miracle cures in the sense of patients suddenly requiring no drugs at all,” Dr. Weber said.
The procedure seems safe, according to the registry. “There’s nothing to suggest the use of these catheters in the renal arteries causes any sort of acute or later-appearing major renal artery compromise.” With the Flex, less than 1% of patients required renal artery reintervention, which was possibly related to ablation trauma stenosis, “but it’s something to keep on our list of things to look for,” Dr. Weber said.
When asked if the registry fully captures adverse events, Dr. Weber said that “I suspect once [Spyral] goes to market, assuming it does go to market, there will be far more rigorous reporting requirements.”
He reported receiving travel funding, as well as consulting and lecture fees, from Medtronic and Boston Scientific, among other companies.
SAN FRANCISCO – Hypertensive patients averaged about a 10-mm Hg drop in 24-hour ambulatory systolic blood pressure and about a 12-mm Hg drop in office systolic blood pressure, 2 years after treatment with Medtronic’s new Symplicity Spyral renal artery denervation catheter, according to a review of the company’s renal artery denervation registry.
No major safety issues were reported, but there was no reduction from baseline in the number of antihypertensive drugs that patients were prescribed, which averaged more than four.
The company withdrew the Flex catheter from development after a large, randomized U.S. trial found no benefit over a sham procedure for resistant hypertension (N Engl J Med. 2014 Apr 10;370[15]:1393-401). “In the future, everything will be built around the Spyral catheter,” said Michael Weber, MD, a Medtronic investigator and a professor of medicine at State University of New York, Brooklyn. He presented the registry findings at the joint scientific sessions of AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The Spyral, he said, has two key advantages over the Flex. The Flex had just a single electrode, so operators had to rotate the tip into four quadrants to fully denervate renal arteries, “a tricky business at the best of times and very often not successfully achieved.” Inadequate ablation might have contributed to the trial failure, Dr. Weber said.
The Spyral catheter, on the other hand, has four electrodes placed radially around a spiral catheter, so all four quadrants can be ablated at once, without undue gymnastics. The Spyral can also enter the smaller branches of the main renal arteries, which might allow for more complete denervation, he said.
“We all anticipate better results with the Spyral, but let’s be cautious. We need more data and obviously data from controlled clinical trials. There’s a lot to be learned yet about this whole procedure,” Dr. Weber said.
Medtronic is planning a large trial of its new device following the recent publication of a successful proof-of-concept study that pitted the Spyral in 38 hypertensives against a sham procedure in 42. The Spyral group had a 5 mm Hg greater reduction in systolic ambulatory blood pressure at 3 months, among other findings. To avoid confounding, investigators took patients off their blood pressure medications during the study (Lancet. 2017 Aug 25. pii: S0140-6736(17)32281-X. doi: 10.1016/S0140-6736[17]32281-X).
Other companies are pushing forward with renal artery denervation, as well; Boston Scientific has its own four-quadrant ablation catheter – Vessix – in the pipeline.
In Medtronic’s denervation registry, office systolic blood pressure reductions were a bit larger at 2 years for the older Flex catheter than with the newer Spyral, 15.7 versus 12.0 mm Hg from a baseline of about 170 mm Hg in both groups. Spyral had a slight edge on 24-hour ambulatory systolic blood pressure at 2 years, with an average reduction of 10.4 versus 8.7 mm Hg from a mean baseline of about 155 mm Hg.
For both devices, “when you look at results patient-by-patient, they are dramatically all over the place, including a significant number of patients whose pressures actually increase. I have to assume that it’s patients” who stop taking their medications after the procedure. On the flip side, “I suspect some of our terrific results are because people finally get a touch of religion after the intervention and start taking their drugs for the first time,” Dr. Weber said.
So far, only a handful of Spyral patients have had ablations in renal artery branches. “It seems to have some benefit as judged by office pressure, but the numbers are small, so it’s premature to draw any conclusions,” he said.
Registry patients were in their early 60s, on average, at baseline, and there were more men than women. As with Spyral, Flex patients had no decrease in hypertension prescriptions over time and averaged more than four. “We have not seen many miracle cures in the sense of patients suddenly requiring no drugs at all,” Dr. Weber said.
The procedure seems safe, according to the registry. “There’s nothing to suggest the use of these catheters in the renal arteries causes any sort of acute or later-appearing major renal artery compromise.” With the Flex, less than 1% of patients required renal artery reintervention, which was possibly related to ablation trauma stenosis, “but it’s something to keep on our list of things to look for,” Dr. Weber said.
When asked if the registry fully captures adverse events, Dr. Weber said that “I suspect once [Spyral] goes to market, assuming it does go to market, there will be far more rigorous reporting requirements.”
He reported receiving travel funding, as well as consulting and lecture fees, from Medtronic and Boston Scientific, among other companies.
AT JOINT HYPERTENSION 2017
Key clinical point:
Major finding: Two years after treatment with Medtronic’s new Symplicity Spyral renal artery denervation catheter, hypertensive patients averaged about a 10-mm Hg drop in 24-hour ambulatory systolic blood pressure and about a 12-mm Hg drop in office systolic blood pressure.
Data source: Review of Medtronic’s renal artery denervation registry
Disclosures: The presenter reported travel funding and consulting and lecture fees from Medtronic and Boston Scientific, among other companies.
RAS derangement linked to CVD risk in adolescents born preterm
SAN FRANCISCO – The renin-angiotensin system (RAS) is out of balance in adolescents born prematurely, according to investigators from Wake Forest School of Medicine in Winston-Salem, N.C.
Among other findings, the amount of circulating angiotensin 1-7, a vasodilator that counteracts the vasoconstrictive and other effects of angiotensin II, was lower relative to angiotensin II in 175 subjects born preterm and assessed at age 14 years, compared with 51 controls born at term.
The findings suggest a possible explanation for why people born prematurely have an increased risk for hypertension and cardiovascular disease, which has been a mystery. If the findings pan out with additional research, they also suggest potential therapeutic targets to attenuate the risk, namely upregulating angiotensin 1-7 and blocking angiotensin II, either at birth or later.
“If you could give medications to shift the balance in the RAS back to what it should be, then maybe you could prevent some of the changes that we see at age 14. With the current treatments, that’s difficult; ACE inhibitors and angiotensin II receptor blockers are (generally) not used in the neonatal period because they can precipitate acute kidney injury.” For older patients, “there’s no indication to use these medications in a subtle situation like we have here,” Dr. South said in an interview at a hypertension science meeting jointly sponsored by the American Heart Association and the American Society of Hypertension.
The direct manipulation of angiotensin 1-7 remains, for now, largely in the realm of clinical research.
The preterm subjects had lower plasma angiotensin II and lower angiotensin 1-7 concentrations, compared with their term peers, but an overall increase in the angiotensin II/angiotensin 1-7 ratio (4.2 vs. 2.4). Preterm subjects also had increased urinary excretion of angiotensin 1-7. The findings were statistically significant, and adjusted for potential confounders.
The differences were exaggerated in obese subjects, about a third in both groups. Obesity is known to be associated with increased angiotensin II activity.
The drop in angiotensin 1-7 was greater in preterm girls than in boys, which was curious because female sex is normally associated with decreased angiotensin II activity, and estrogen normally upregulates angiotensin 1-7; perhaps in prematurity, there’s a breakdown in the normal response to estrogen, Dr. South said.
Whatever the case, it’s possible the risk of hypertension and cardiovascular disease from preterm birth might be especially high in obese patients and women, he said.
The preterm group had a mean gestational age of 28 weeks, and a mean birth weight of 1.1 kg. The term group was born at a mean of 40 weeks, with a mean birth weight of 3.5 kg. At age 14 years, preterm subjects were shorter and weighed less than their peers.
Mean systolic and diastolic blood pressures were higher in the preterm group, and 21 preterm subjects (12%) had blood pressures at or above 120/80 mm Hg, vs. one subject (2%) in the term group.
Maternal hypertension and smoking during pregnancy, and C-section delivery, were far more common in the preterm group, as was Medicaid use at age 14 years. There were slightly more girls than boys in both groups, and just over 40% of the subjects in each were black.
The Wake Forest team continues to follow their preterm subjects, who are now in their mid-twenties. “If we can correlate what we found at age 14 with” early development of disease, “it will give us more of an indication that this is actually true causation, not just an association,” Dr. South said.
The investigators had no industry disclosures. The work was funded in part by the National Institutes of Health.
[email protected]
SAN FRANCISCO – The renin-angiotensin system (RAS) is out of balance in adolescents born prematurely, according to investigators from Wake Forest School of Medicine in Winston-Salem, N.C.
Among other findings, the amount of circulating angiotensin 1-7, a vasodilator that counteracts the vasoconstrictive and other effects of angiotensin II, was lower relative to angiotensin II in 175 subjects born preterm and assessed at age 14 years, compared with 51 controls born at term.
The findings suggest a possible explanation for why people born prematurely have an increased risk for hypertension and cardiovascular disease, which has been a mystery. If the findings pan out with additional research, they also suggest potential therapeutic targets to attenuate the risk, namely upregulating angiotensin 1-7 and blocking angiotensin II, either at birth or later.
“If you could give medications to shift the balance in the RAS back to what it should be, then maybe you could prevent some of the changes that we see at age 14. With the current treatments, that’s difficult; ACE inhibitors and angiotensin II receptor blockers are (generally) not used in the neonatal period because they can precipitate acute kidney injury.” For older patients, “there’s no indication to use these medications in a subtle situation like we have here,” Dr. South said in an interview at a hypertension science meeting jointly sponsored by the American Heart Association and the American Society of Hypertension.
The direct manipulation of angiotensin 1-7 remains, for now, largely in the realm of clinical research.
The preterm subjects had lower plasma angiotensin II and lower angiotensin 1-7 concentrations, compared with their term peers, but an overall increase in the angiotensin II/angiotensin 1-7 ratio (4.2 vs. 2.4). Preterm subjects also had increased urinary excretion of angiotensin 1-7. The findings were statistically significant, and adjusted for potential confounders.
The differences were exaggerated in obese subjects, about a third in both groups. Obesity is known to be associated with increased angiotensin II activity.
The drop in angiotensin 1-7 was greater in preterm girls than in boys, which was curious because female sex is normally associated with decreased angiotensin II activity, and estrogen normally upregulates angiotensin 1-7; perhaps in prematurity, there’s a breakdown in the normal response to estrogen, Dr. South said.
Whatever the case, it’s possible the risk of hypertension and cardiovascular disease from preterm birth might be especially high in obese patients and women, he said.
The preterm group had a mean gestational age of 28 weeks, and a mean birth weight of 1.1 kg. The term group was born at a mean of 40 weeks, with a mean birth weight of 3.5 kg. At age 14 years, preterm subjects were shorter and weighed less than their peers.
Mean systolic and diastolic blood pressures were higher in the preterm group, and 21 preterm subjects (12%) had blood pressures at or above 120/80 mm Hg, vs. one subject (2%) in the term group.
Maternal hypertension and smoking during pregnancy, and C-section delivery, were far more common in the preterm group, as was Medicaid use at age 14 years. There were slightly more girls than boys in both groups, and just over 40% of the subjects in each were black.
The Wake Forest team continues to follow their preterm subjects, who are now in their mid-twenties. “If we can correlate what we found at age 14 with” early development of disease, “it will give us more of an indication that this is actually true causation, not just an association,” Dr. South said.
The investigators had no industry disclosures. The work was funded in part by the National Institutes of Health.
[email protected]
SAN FRANCISCO – The renin-angiotensin system (RAS) is out of balance in adolescents born prematurely, according to investigators from Wake Forest School of Medicine in Winston-Salem, N.C.
Among other findings, the amount of circulating angiotensin 1-7, a vasodilator that counteracts the vasoconstrictive and other effects of angiotensin II, was lower relative to angiotensin II in 175 subjects born preterm and assessed at age 14 years, compared with 51 controls born at term.
The findings suggest a possible explanation for why people born prematurely have an increased risk for hypertension and cardiovascular disease, which has been a mystery. If the findings pan out with additional research, they also suggest potential therapeutic targets to attenuate the risk, namely upregulating angiotensin 1-7 and blocking angiotensin II, either at birth or later.
“If you could give medications to shift the balance in the RAS back to what it should be, then maybe you could prevent some of the changes that we see at age 14. With the current treatments, that’s difficult; ACE inhibitors and angiotensin II receptor blockers are (generally) not used in the neonatal period because they can precipitate acute kidney injury.” For older patients, “there’s no indication to use these medications in a subtle situation like we have here,” Dr. South said in an interview at a hypertension science meeting jointly sponsored by the American Heart Association and the American Society of Hypertension.
The direct manipulation of angiotensin 1-7 remains, for now, largely in the realm of clinical research.
The preterm subjects had lower plasma angiotensin II and lower angiotensin 1-7 concentrations, compared with their term peers, but an overall increase in the angiotensin II/angiotensin 1-7 ratio (4.2 vs. 2.4). Preterm subjects also had increased urinary excretion of angiotensin 1-7. The findings were statistically significant, and adjusted for potential confounders.
The differences were exaggerated in obese subjects, about a third in both groups. Obesity is known to be associated with increased angiotensin II activity.
The drop in angiotensin 1-7 was greater in preterm girls than in boys, which was curious because female sex is normally associated with decreased angiotensin II activity, and estrogen normally upregulates angiotensin 1-7; perhaps in prematurity, there’s a breakdown in the normal response to estrogen, Dr. South said.
Whatever the case, it’s possible the risk of hypertension and cardiovascular disease from preterm birth might be especially high in obese patients and women, he said.
The preterm group had a mean gestational age of 28 weeks, and a mean birth weight of 1.1 kg. The term group was born at a mean of 40 weeks, with a mean birth weight of 3.5 kg. At age 14 years, preterm subjects were shorter and weighed less than their peers.
Mean systolic and diastolic blood pressures were higher in the preterm group, and 21 preterm subjects (12%) had blood pressures at or above 120/80 mm Hg, vs. one subject (2%) in the term group.
Maternal hypertension and smoking during pregnancy, and C-section delivery, were far more common in the preterm group, as was Medicaid use at age 14 years. There were slightly more girls than boys in both groups, and just over 40% of the subjects in each were black.
The Wake Forest team continues to follow their preterm subjects, who are now in their mid-twenties. “If we can correlate what we found at age 14 with” early development of disease, “it will give us more of an indication that this is actually true causation, not just an association,” Dr. South said.
The investigators had no industry disclosures. The work was funded in part by the National Institutes of Health.
[email protected]
AT THE AHA/ASH JOINT SCIENTIFIC HYPERTENSION MEETING
Key clinical point:
Major finding: The preterm subjects had lower plasma angiotensin II and lower angiotensin 1-7 concentrations, compared with their term peers, but an overall increase in the angiotensin II/angiotensin 1-7 ratio (4.2 vs. 2.4).
Data source: Comparison of 175 subjects born preterm to 51 controls born at term, assessed at age 14 years.
Disclosures: The investigators had no industry disclosures. The work was funded in part by the National Institutes of Health.