Leadless pacemaker matches conventional transvenous outcomes

Leadless pacing shows promise
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Leadless pacemaker matches conventional transvenous outcomes

ORLANDO – A leadless transcatheter pacemaker rivals conventional transvenous pacemakers in terms of pacing capture and major complications, according to data presented at the American Heart Association scientific sessions and published simultaneously in the New England Journal of Medicine.

The prospective multicenter study involved 725 patients requiring ventricular pacing, of whom 719 were successful implanted with the leadless Micra Transcatheter Pacemaking System and followed for 6 months.

Of the 297 patients included in the primary efficacy analysis, 98.3% showed a 6-month pacing capture threshold of no greater than 2.0 V, with a mean pacing capture threshold at implantation of 0.63 V and 0.54 V at 6 months.

The leadless device also was associated with half the incidence of major complications, compared with data from a historical control cohort (4% vs. 7.4%; hazard ratio, 0.49; P = .001), as well as fewer hospitalizations and fewer system revisions due to complications.

“Complications that lead to death or that required invasive revision, termination of therapy, or hospitalization or extension of hospitalization occurred in 4% of the patients; this finding is in line with recent reports of transvenous systems and was significantly lower than the rate in the control group,” wrote Dr. Dwight Reynolds of the University of Oklahoma Health Sciences Center, Oklahoma City, and coauthors (N Engl J Med. Nov 9. doi: 10.1056/NEJMoa1511643).

The study was supported by Micra manufacturer Medtronic. Most authors reported personal fees, grants, and advisory board positions from private industry, including Medtronic. Two authors are Medtronic employees.

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Pacemaker leads are the “Achilles’ heel” of pacing and defibrillation systems, so a self-contained, leadless pacemaker that can be placed directly into the heart is an appealing prospect.

Although newer devices such as this one can be used only for single-chamber ventricular pacing and therefore will have limited usefulness for the majority of pacemaker recipients, these encouraging short-term results show the promise of leadless pacing.

Dr. Mark S. Link is with the cardiac arrhythmia service at Tufts Medical Center, Boston. These comments were taken from an accompanying editorial (N Engl J Med. 2015, Nov 9. doi: 10.1056/NEJMe1513625). No conflicts of interest were declared.

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Pacemaker leads are the “Achilles’ heel” of pacing and defibrillation systems, so a self-contained, leadless pacemaker that can be placed directly into the heart is an appealing prospect.

Although newer devices such as this one can be used only for single-chamber ventricular pacing and therefore will have limited usefulness for the majority of pacemaker recipients, these encouraging short-term results show the promise of leadless pacing.

Dr. Mark S. Link is with the cardiac arrhythmia service at Tufts Medical Center, Boston. These comments were taken from an accompanying editorial (N Engl J Med. 2015, Nov 9. doi: 10.1056/NEJMe1513625). No conflicts of interest were declared.

Body

Pacemaker leads are the “Achilles’ heel” of pacing and defibrillation systems, so a self-contained, leadless pacemaker that can be placed directly into the heart is an appealing prospect.

Although newer devices such as this one can be used only for single-chamber ventricular pacing and therefore will have limited usefulness for the majority of pacemaker recipients, these encouraging short-term results show the promise of leadless pacing.

Dr. Mark S. Link is with the cardiac arrhythmia service at Tufts Medical Center, Boston. These comments were taken from an accompanying editorial (N Engl J Med. 2015, Nov 9. doi: 10.1056/NEJMe1513625). No conflicts of interest were declared.

Title
Leadless pacing shows promise
Leadless pacing shows promise

ORLANDO – A leadless transcatheter pacemaker rivals conventional transvenous pacemakers in terms of pacing capture and major complications, according to data presented at the American Heart Association scientific sessions and published simultaneously in the New England Journal of Medicine.

The prospective multicenter study involved 725 patients requiring ventricular pacing, of whom 719 were successful implanted with the leadless Micra Transcatheter Pacemaking System and followed for 6 months.

Of the 297 patients included in the primary efficacy analysis, 98.3% showed a 6-month pacing capture threshold of no greater than 2.0 V, with a mean pacing capture threshold at implantation of 0.63 V and 0.54 V at 6 months.

The leadless device also was associated with half the incidence of major complications, compared with data from a historical control cohort (4% vs. 7.4%; hazard ratio, 0.49; P = .001), as well as fewer hospitalizations and fewer system revisions due to complications.

“Complications that lead to death or that required invasive revision, termination of therapy, or hospitalization or extension of hospitalization occurred in 4% of the patients; this finding is in line with recent reports of transvenous systems and was significantly lower than the rate in the control group,” wrote Dr. Dwight Reynolds of the University of Oklahoma Health Sciences Center, Oklahoma City, and coauthors (N Engl J Med. Nov 9. doi: 10.1056/NEJMoa1511643).

The study was supported by Micra manufacturer Medtronic. Most authors reported personal fees, grants, and advisory board positions from private industry, including Medtronic. Two authors are Medtronic employees.

ORLANDO – A leadless transcatheter pacemaker rivals conventional transvenous pacemakers in terms of pacing capture and major complications, according to data presented at the American Heart Association scientific sessions and published simultaneously in the New England Journal of Medicine.

The prospective multicenter study involved 725 patients requiring ventricular pacing, of whom 719 were successful implanted with the leadless Micra Transcatheter Pacemaking System and followed for 6 months.

Of the 297 patients included in the primary efficacy analysis, 98.3% showed a 6-month pacing capture threshold of no greater than 2.0 V, with a mean pacing capture threshold at implantation of 0.63 V and 0.54 V at 6 months.

The leadless device also was associated with half the incidence of major complications, compared with data from a historical control cohort (4% vs. 7.4%; hazard ratio, 0.49; P = .001), as well as fewer hospitalizations and fewer system revisions due to complications.

“Complications that lead to death or that required invasive revision, termination of therapy, or hospitalization or extension of hospitalization occurred in 4% of the patients; this finding is in line with recent reports of transvenous systems and was significantly lower than the rate in the control group,” wrote Dr. Dwight Reynolds of the University of Oklahoma Health Sciences Center, Oklahoma City, and coauthors (N Engl J Med. Nov 9. doi: 10.1056/NEJMoa1511643).

The study was supported by Micra manufacturer Medtronic. Most authors reported personal fees, grants, and advisory board positions from private industry, including Medtronic. Two authors are Medtronic employees.

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Key clinical point: A leadless transcatheter pacemaker has shown similar outcomes in terms of pacing capture and major complications to conventional transvenous pacemakers.

Major finding:A leadless transcatheter pacemaker achieved a 6-month pacing capture threshold no greater than 2.0 V in 98.3% of patients.

Data source: A prospective multicenter study involving 725 patients requiring ventricular pacing.

Disclosures: The study was supported by Micra manufacturer Medtronic. Most authors reported personal fees, grants, and advisory board positions from private industry, including Medtronic. Two authors are Medtronic employees.

AHA: Homemade meals cut type 2 diabetes risk by 13%

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ORLANDO – The more homemade meals a middle-aged person eats, the lower the risk of developing type 2 diabetes.

That’s the key take-away from a long-term prospective observational study of nearly 100,000 health care professionals. In an analysis adjusted for demographics and lifestyle factors, the participants who ate an average of 11-14 home-prepared lunches and dinners per week had a 13% lower risk of developing type 2 diabetes than those consuming 6 or fewer, Geng Zong, Ph.D., reported at the American Heart Association scientific sessions.

Geng Zong, Ph.D.

He scrutinized the eating habits of 57,994 women in the Nurses’ Health Study and 41,679 men in the Health Professionals Follow-Up Study, all of whom were free of cardiovascular disease, diabetes, and cancer at enrollment. During 26 years of biannual prospective follow-up, or 2.3 million person-years, 8,959 subjects were diagnosed with type 2 diabetes.

A dose-response relationship was evident. Looking at homemade meals as a continuous variable, each home-prepared lunch or dinner eaten per week decreased the long-term risk of developing type 2 diabetes by 1%-2%, according to Dr. Zong of Harvard School of Public Health, Boston.

He noted that, since this was an observational study, it can’t prove causality. Nonetheless, he offered several possible explanations to help explain the observed association. For one, health care professionals who ate 11-14 homemade lunches and dinners per week had a 15% lower risk of developing obesity during the first 8 years of follow-up, compared with those who ate 0-6. Men who ate in that fashion gained about 1 kg less body weight in the first 8 years of follow-up and women gained about 0.5 kg less than those who ate fewer home-prepared meals – that’s probably because eating out often means consuming high-fat, high-salt, processed fast foods.

Participants who frequently ate home-prepared meals also consumed fewer sugar-sweetened beverages. Dr. Zong’s coinvestigators have previously shown that drinking sugar-sweetened beverages is associated with increased risk of metabolic syndrome and type 2 diabetes (Diabetes Care. 2010;33[11]:2477-83).

Breakfast eating patterns weren’t included in the study because there were insufficient data. The study was funded by the National Institutes of Health. Dr. Zong reported having no financial conflicts of interest.

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ORLANDO – The more homemade meals a middle-aged person eats, the lower the risk of developing type 2 diabetes.

That’s the key take-away from a long-term prospective observational study of nearly 100,000 health care professionals. In an analysis adjusted for demographics and lifestyle factors, the participants who ate an average of 11-14 home-prepared lunches and dinners per week had a 13% lower risk of developing type 2 diabetes than those consuming 6 or fewer, Geng Zong, Ph.D., reported at the American Heart Association scientific sessions.

Geng Zong, Ph.D.

He scrutinized the eating habits of 57,994 women in the Nurses’ Health Study and 41,679 men in the Health Professionals Follow-Up Study, all of whom were free of cardiovascular disease, diabetes, and cancer at enrollment. During 26 years of biannual prospective follow-up, or 2.3 million person-years, 8,959 subjects were diagnosed with type 2 diabetes.

A dose-response relationship was evident. Looking at homemade meals as a continuous variable, each home-prepared lunch or dinner eaten per week decreased the long-term risk of developing type 2 diabetes by 1%-2%, according to Dr. Zong of Harvard School of Public Health, Boston.

He noted that, since this was an observational study, it can’t prove causality. Nonetheless, he offered several possible explanations to help explain the observed association. For one, health care professionals who ate 11-14 homemade lunches and dinners per week had a 15% lower risk of developing obesity during the first 8 years of follow-up, compared with those who ate 0-6. Men who ate in that fashion gained about 1 kg less body weight in the first 8 years of follow-up and women gained about 0.5 kg less than those who ate fewer home-prepared meals – that’s probably because eating out often means consuming high-fat, high-salt, processed fast foods.

Participants who frequently ate home-prepared meals also consumed fewer sugar-sweetened beverages. Dr. Zong’s coinvestigators have previously shown that drinking sugar-sweetened beverages is associated with increased risk of metabolic syndrome and type 2 diabetes (Diabetes Care. 2010;33[11]:2477-83).

Breakfast eating patterns weren’t included in the study because there were insufficient data. The study was funded by the National Institutes of Health. Dr. Zong reported having no financial conflicts of interest.

[email protected]

ORLANDO – The more homemade meals a middle-aged person eats, the lower the risk of developing type 2 diabetes.

That’s the key take-away from a long-term prospective observational study of nearly 100,000 health care professionals. In an analysis adjusted for demographics and lifestyle factors, the participants who ate an average of 11-14 home-prepared lunches and dinners per week had a 13% lower risk of developing type 2 diabetes than those consuming 6 or fewer, Geng Zong, Ph.D., reported at the American Heart Association scientific sessions.

Geng Zong, Ph.D.

He scrutinized the eating habits of 57,994 women in the Nurses’ Health Study and 41,679 men in the Health Professionals Follow-Up Study, all of whom were free of cardiovascular disease, diabetes, and cancer at enrollment. During 26 years of biannual prospective follow-up, or 2.3 million person-years, 8,959 subjects were diagnosed with type 2 diabetes.

A dose-response relationship was evident. Looking at homemade meals as a continuous variable, each home-prepared lunch or dinner eaten per week decreased the long-term risk of developing type 2 diabetes by 1%-2%, according to Dr. Zong of Harvard School of Public Health, Boston.

He noted that, since this was an observational study, it can’t prove causality. Nonetheless, he offered several possible explanations to help explain the observed association. For one, health care professionals who ate 11-14 homemade lunches and dinners per week had a 15% lower risk of developing obesity during the first 8 years of follow-up, compared with those who ate 0-6. Men who ate in that fashion gained about 1 kg less body weight in the first 8 years of follow-up and women gained about 0.5 kg less than those who ate fewer home-prepared meals – that’s probably because eating out often means consuming high-fat, high-salt, processed fast foods.

Participants who frequently ate home-prepared meals also consumed fewer sugar-sweetened beverages. Dr. Zong’s coinvestigators have previously shown that drinking sugar-sweetened beverages is associated with increased risk of metabolic syndrome and type 2 diabetes (Diabetes Care. 2010;33[11]:2477-83).

Breakfast eating patterns weren’t included in the study because there were insufficient data. The study was funded by the National Institutes of Health. Dr. Zong reported having no financial conflicts of interest.

[email protected]

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Key clinical point: Eating more home-prepared lunches and dinners is associated in dose-dependent fashion with lower risk of developing type 2 diabetes.

Major finding: Middle-aged subjects who ate 11-14 home-prepared meals per week had an adjusted 13% lower risk of developing type 2 diabetes than did those consuming 6 or fewer.

Data Source: This prospective observational study featured 26 years of biannual follow-up of nearly 100,000 male and female health care professionals in the Nurses’ Health Study and the Health Professionals Follow-Up Study.

Disclosures: The study was funded by the National Institutes of Health. The presenter reported having no financial conflicts.

VIDEO: Start varenicline during hospitalization for heart attack

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VIDEO: Start varenicline during hospitalization for heart attack

ORLANDO – Initiating varenicline while smokers are hospitalized for acute coronary syndrome (ACS) is an effective strategy for boosting 6-month smoking abstinence rates in this extremely high–cardiovascular risk population, Dr. Mark J. Eisenberg said in an interview at the American Heart Association scientific sessions.

At the meeting, Dr. Eisenberg presented the results of the EVITA trial, a multicenter, randomized, double-blind study of 303 U.S. and Canadian patients, all longtime smokers, who began a 12-week course of varenicline (Chantix) at 1 mg twice daily or placebo while hospitalized for ACS. Participants had been smokers for an average of 36 years and smoked 22 cigarettes per day at the time of their ACS.

The 24-week rate of biochemically confirmed abstinence in the placebo group was 32.5%. That’s typical. Numerous studies have shown that less than one-third of smokers remain abstinent once discharged from the hospital following an ACS.

In contrast, the 24-week abstinence rate in the varenicline group was 47.3%. The number needed to treat with varenicline to achieve one additional quitter through 6 months of follow-up was 6.8, according to Dr. Eisenberg, professor of medicine at McGill University and director of the cardiovascular health services research program at Jewish General Hospital, both in Montreal.

Observers hailed this as a practice-changing study, and Dr. Eisenberg concurred. Noting that cardiologists are already comfortable in starting ACS patients on statins, beta-blockers, and aspirin while in hospital, he predicted physicians will seize this unique opportunity to help patients quit smoking as well.

“This is a teachable moment,” Dr. Eisenberg observed. “The public health benefit for smoking cessation in this population is huge. You can cut their risk of death and significant morbidity in half if you can get them to stop smoking.”

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

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ORLANDO – Initiating varenicline while smokers are hospitalized for acute coronary syndrome (ACS) is an effective strategy for boosting 6-month smoking abstinence rates in this extremely high–cardiovascular risk population, Dr. Mark J. Eisenberg said in an interview at the American Heart Association scientific sessions.

At the meeting, Dr. Eisenberg presented the results of the EVITA trial, a multicenter, randomized, double-blind study of 303 U.S. and Canadian patients, all longtime smokers, who began a 12-week course of varenicline (Chantix) at 1 mg twice daily or placebo while hospitalized for ACS. Participants had been smokers for an average of 36 years and smoked 22 cigarettes per day at the time of their ACS.

The 24-week rate of biochemically confirmed abstinence in the placebo group was 32.5%. That’s typical. Numerous studies have shown that less than one-third of smokers remain abstinent once discharged from the hospital following an ACS.

In contrast, the 24-week abstinence rate in the varenicline group was 47.3%. The number needed to treat with varenicline to achieve one additional quitter through 6 months of follow-up was 6.8, according to Dr. Eisenberg, professor of medicine at McGill University and director of the cardiovascular health services research program at Jewish General Hospital, both in Montreal.

Observers hailed this as a practice-changing study, and Dr. Eisenberg concurred. Noting that cardiologists are already comfortable in starting ACS patients on statins, beta-blockers, and aspirin while in hospital, he predicted physicians will seize this unique opportunity to help patients quit smoking as well.

“This is a teachable moment,” Dr. Eisenberg observed. “The public health benefit for smoking cessation in this population is huge. You can cut their risk of death and significant morbidity in half if you can get them to stop smoking.”

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

[email protected]

ORLANDO – Initiating varenicline while smokers are hospitalized for acute coronary syndrome (ACS) is an effective strategy for boosting 6-month smoking abstinence rates in this extremely high–cardiovascular risk population, Dr. Mark J. Eisenberg said in an interview at the American Heart Association scientific sessions.

At the meeting, Dr. Eisenberg presented the results of the EVITA trial, a multicenter, randomized, double-blind study of 303 U.S. and Canadian patients, all longtime smokers, who began a 12-week course of varenicline (Chantix) at 1 mg twice daily or placebo while hospitalized for ACS. Participants had been smokers for an average of 36 years and smoked 22 cigarettes per day at the time of their ACS.

The 24-week rate of biochemically confirmed abstinence in the placebo group was 32.5%. That’s typical. Numerous studies have shown that less than one-third of smokers remain abstinent once discharged from the hospital following an ACS.

In contrast, the 24-week abstinence rate in the varenicline group was 47.3%. The number needed to treat with varenicline to achieve one additional quitter through 6 months of follow-up was 6.8, according to Dr. Eisenberg, professor of medicine at McGill University and director of the cardiovascular health services research program at Jewish General Hospital, both in Montreal.

Observers hailed this as a practice-changing study, and Dr. Eisenberg concurred. Noting that cardiologists are already comfortable in starting ACS patients on statins, beta-blockers, and aspirin while in hospital, he predicted physicians will seize this unique opportunity to help patients quit smoking as well.

“This is a teachable moment,” Dr. Eisenberg observed. “The public health benefit for smoking cessation in this population is huge. You can cut their risk of death and significant morbidity in half if you can get them to stop smoking.”

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

[email protected]

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8.5 million U.S. patients meeting SPRINT criteria go untreated

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8.5 million U.S. patients meeting SPRINT criteria go untreated

More than 16 million adults in the United States could benefit from a lower systolic blood pressure treatment goal of 120 mm Hg or less, as explored in the earlier SPRINT (Systolic Blood Pressure Intervention Trial) study, say researchers.

The terminated SPRINT trial showed that achieving a systolic blood pressure goal of less than 120 mm Hg in adults at high risk of cardiovascular disease was associated with a 30% relative reduction in cardiovascular disease events and 25% reduction in mortality, compared with those achieving less than 140 mm Hg systolic BP.

©Dr. Heinz Linke/iStockphoto.com

In a study presented at the American Heart Association scientific sessions and published simultaneously Nov. 9 in the Journal of the American College of Cardiology, researchers conducted a cross-sectional, population-based study using NHANES data from 2007-2012 to generalize the SPRINT data to a broader sample of U.S. adults with high cardiovascular disease risk and a systolic BP of 130-180 mm Hg.

They concluded that overall, 16.8 million people, or 7.6% of U.S. adults, met the SPRINT eligibility criteria, but more than half – 8.5 million – were not being treated for hypertension, including 5.2 million individuals with a systolic blood pressure of 140 mm Hg or above.

“Characterizing U.S. adults who are potentially eligible for antihypertensive treatment initiation or intensification to achieve a SBP less than 120 mm Hg may provide the health care and scientific community with information for understanding the relevance and impact of the findings from SPRINT,” wrote Adam P. Bress, Pharm.D., of the University of Utah, Salt Lake City, and his coauthors.

The study was supported by the National Institutes of Health. No conflicts of interest were declared.

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More than 16 million adults in the United States could benefit from a lower systolic blood pressure treatment goal of 120 mm Hg or less, as explored in the earlier SPRINT (Systolic Blood Pressure Intervention Trial) study, say researchers.

The terminated SPRINT trial showed that achieving a systolic blood pressure goal of less than 120 mm Hg in adults at high risk of cardiovascular disease was associated with a 30% relative reduction in cardiovascular disease events and 25% reduction in mortality, compared with those achieving less than 140 mm Hg systolic BP.

©Dr. Heinz Linke/iStockphoto.com

In a study presented at the American Heart Association scientific sessions and published simultaneously Nov. 9 in the Journal of the American College of Cardiology, researchers conducted a cross-sectional, population-based study using NHANES data from 2007-2012 to generalize the SPRINT data to a broader sample of U.S. adults with high cardiovascular disease risk and a systolic BP of 130-180 mm Hg.

They concluded that overall, 16.8 million people, or 7.6% of U.S. adults, met the SPRINT eligibility criteria, but more than half – 8.5 million – were not being treated for hypertension, including 5.2 million individuals with a systolic blood pressure of 140 mm Hg or above.

“Characterizing U.S. adults who are potentially eligible for antihypertensive treatment initiation or intensification to achieve a SBP less than 120 mm Hg may provide the health care and scientific community with information for understanding the relevance and impact of the findings from SPRINT,” wrote Adam P. Bress, Pharm.D., of the University of Utah, Salt Lake City, and his coauthors.

The study was supported by the National Institutes of Health. No conflicts of interest were declared.

More than 16 million adults in the United States could benefit from a lower systolic blood pressure treatment goal of 120 mm Hg or less, as explored in the earlier SPRINT (Systolic Blood Pressure Intervention Trial) study, say researchers.

The terminated SPRINT trial showed that achieving a systolic blood pressure goal of less than 120 mm Hg in adults at high risk of cardiovascular disease was associated with a 30% relative reduction in cardiovascular disease events and 25% reduction in mortality, compared with those achieving less than 140 mm Hg systolic BP.

©Dr. Heinz Linke/iStockphoto.com

In a study presented at the American Heart Association scientific sessions and published simultaneously Nov. 9 in the Journal of the American College of Cardiology, researchers conducted a cross-sectional, population-based study using NHANES data from 2007-2012 to generalize the SPRINT data to a broader sample of U.S. adults with high cardiovascular disease risk and a systolic BP of 130-180 mm Hg.

They concluded that overall, 16.8 million people, or 7.6% of U.S. adults, met the SPRINT eligibility criteria, but more than half – 8.5 million – were not being treated for hypertension, including 5.2 million individuals with a systolic blood pressure of 140 mm Hg or above.

“Characterizing U.S. adults who are potentially eligible for antihypertensive treatment initiation or intensification to achieve a SBP less than 120 mm Hg may provide the health care and scientific community with information for understanding the relevance and impact of the findings from SPRINT,” wrote Adam P. Bress, Pharm.D., of the University of Utah, Salt Lake City, and his coauthors.

The study was supported by the National Institutes of Health. No conflicts of interest were declared.

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Key clinical point:More than 16 million U.S. adults could benefit from a lower systolic blood pressure treatment goal of 120 mm Hg or less.

Major finding: More than half of the 16.8 million (7.6%) U.S. adults who meet the SPRINT eligibility criteria are not being treated for hypertension.

Data source: A cross-sectional, population-based study using NHANES data.

Disclosures: The study was supported by the National Institutes of Health. No conflicts of interest were declared.

VIDEO: SPRINT Resets Many Patients’ Hypertension Treatment Target

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ORLANDO – The paradigm-shifting results from the SPRINT trial showed the added benefit from a new target systolic blood-pressure goal of less than 120 mm Hg for many patients with risk factors for cardiovascular disease, but the results did not address the issue of which systolic blood pressure to use to identify patients who have hypertension and require drug intervention.

“We tested a target of less than 120 mm Hg against a target of less than 140 mm Hg; the question of whom to treat and to whom this applies” did not get tested in SPRINT (Systolic Blood Pressure Intervention Trial), Dr. Jackson T. Wright Jr. said in an interview at the American Heart Association scientific sessions.

“What the trial showed was that treating to a systolic blood pressure of less than 120 mm Hg reduced the primary, combined endpoint by [a relative] 25%, reduced all-cause mortality by [a relative] 27%, and reduced heart failure by [a relative] 38%” compared with patients treated to a target systolic pressure of less than 140 mm Hg, said Dr. Wright, professor and director of the clinical hypertension program at University Hospitals Case Medical Center in Cleveland. Concurrently with the study’s report, the SPRINT results appeared in an article published online (N Engl J Med. 2015;doi:10.1056/NEJMoa1511939).

Dr. Wright acknowledged that the more aggressive antihypertensive regimen used in SPRINT to get patients’ systolic blood pressure to a goal of less than 120 mm Hg resulted in an absolute 2.2% increased rate of serious adverse events attributable to study treatment compared with the control patients treated to a target pressure of less than 140 mm Hg, but he contended that the benefits from lower pressure outweighed this risk. Patients in the more aggressive arm required an average of 2.8 drugs/patient compared with an average of 1.8 antihypertensive drugs used by control patients. The average achieved systolic blood pressure in the aggressive arm was 121.5 mm Hg, and 134.6 mm Hg in the control arm.

Patients enrolled in SPRINT had to be at least 50 years old, have a systolic blood pressure of 130-180 mm Hg, and have an increased risk for cardiovascular disease events. That risk was defined as having at least one of these factors: clinical or subclinical cardiovascular disease other than stroke; chronic kidney disease (but excluding polycystic kidney disease) with an estimated glomerular filtration rate of 20-59 mL/min per 1.73 m2; a 10-year cardiovascular disease risk of at least 15% based on the Framingham risk score; or an age of 75 years or older. The study excluded patients with a history of stroke or diabetes.

Subgroup analyses showed consistent benefit across all subgroups including age, gender, race, the presence or absence of chronic kidney disease, and systolic blood pressure at entry. A third of patients entered the trial with a systolic blood pressure of 132 mm Hg or less. Also at baseline, 91% of enrolled patients had already been receiving antihypertensive drugs. Overall, enrolled patients were receiving an average of 1.8 antihypertensive drugs each when they entered the study.

Patients enrolled in SPRINT received treatment for an average of 3.26 years. The investigators had designed SPRINT to run for 5 years but stopped the trial sooner than planned in August when the study’s data and safety monitoring board identified clear evidence of the superiority of the more aggressive treatment that fulfilled the trials prespecified stopping criterion.

SPRINT received no commercial funding. The study received antihypertensive drugs from Arbor and Takeda at no charge for a small percentage of enrolled patients. Dr. Wright had no disclosures.

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ORLANDO – The paradigm-shifting results from the SPRINT trial showed the added benefit from a new target systolic blood-pressure goal of less than 120 mm Hg for many patients with risk factors for cardiovascular disease, but the results did not address the issue of which systolic blood pressure to use to identify patients who have hypertension and require drug intervention.

“We tested a target of less than 120 mm Hg against a target of less than 140 mm Hg; the question of whom to treat and to whom this applies” did not get tested in SPRINT (Systolic Blood Pressure Intervention Trial), Dr. Jackson T. Wright Jr. said in an interview at the American Heart Association scientific sessions.

“What the trial showed was that treating to a systolic blood pressure of less than 120 mm Hg reduced the primary, combined endpoint by [a relative] 25%, reduced all-cause mortality by [a relative] 27%, and reduced heart failure by [a relative] 38%” compared with patients treated to a target systolic pressure of less than 140 mm Hg, said Dr. Wright, professor and director of the clinical hypertension program at University Hospitals Case Medical Center in Cleveland. Concurrently with the study’s report, the SPRINT results appeared in an article published online (N Engl J Med. 2015;doi:10.1056/NEJMoa1511939).

Dr. Wright acknowledged that the more aggressive antihypertensive regimen used in SPRINT to get patients’ systolic blood pressure to a goal of less than 120 mm Hg resulted in an absolute 2.2% increased rate of serious adverse events attributable to study treatment compared with the control patients treated to a target pressure of less than 140 mm Hg, but he contended that the benefits from lower pressure outweighed this risk. Patients in the more aggressive arm required an average of 2.8 drugs/patient compared with an average of 1.8 antihypertensive drugs used by control patients. The average achieved systolic blood pressure in the aggressive arm was 121.5 mm Hg, and 134.6 mm Hg in the control arm.

Patients enrolled in SPRINT had to be at least 50 years old, have a systolic blood pressure of 130-180 mm Hg, and have an increased risk for cardiovascular disease events. That risk was defined as having at least one of these factors: clinical or subclinical cardiovascular disease other than stroke; chronic kidney disease (but excluding polycystic kidney disease) with an estimated glomerular filtration rate of 20-59 mL/min per 1.73 m2; a 10-year cardiovascular disease risk of at least 15% based on the Framingham risk score; or an age of 75 years or older. The study excluded patients with a history of stroke or diabetes.

Subgroup analyses showed consistent benefit across all subgroups including age, gender, race, the presence or absence of chronic kidney disease, and systolic blood pressure at entry. A third of patients entered the trial with a systolic blood pressure of 132 mm Hg or less. Also at baseline, 91% of enrolled patients had already been receiving antihypertensive drugs. Overall, enrolled patients were receiving an average of 1.8 antihypertensive drugs each when they entered the study.

Patients enrolled in SPRINT received treatment for an average of 3.26 years. The investigators had designed SPRINT to run for 5 years but stopped the trial sooner than planned in August when the study’s data and safety monitoring board identified clear evidence of the superiority of the more aggressive treatment that fulfilled the trials prespecified stopping criterion.

SPRINT received no commercial funding. The study received antihypertensive drugs from Arbor and Takeda at no charge for a small percentage of enrolled patients. Dr. Wright had no disclosures.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

ORLANDO – The paradigm-shifting results from the SPRINT trial showed the added benefit from a new target systolic blood-pressure goal of less than 120 mm Hg for many patients with risk factors for cardiovascular disease, but the results did not address the issue of which systolic blood pressure to use to identify patients who have hypertension and require drug intervention.

“We tested a target of less than 120 mm Hg against a target of less than 140 mm Hg; the question of whom to treat and to whom this applies” did not get tested in SPRINT (Systolic Blood Pressure Intervention Trial), Dr. Jackson T. Wright Jr. said in an interview at the American Heart Association scientific sessions.

“What the trial showed was that treating to a systolic blood pressure of less than 120 mm Hg reduced the primary, combined endpoint by [a relative] 25%, reduced all-cause mortality by [a relative] 27%, and reduced heart failure by [a relative] 38%” compared with patients treated to a target systolic pressure of less than 140 mm Hg, said Dr. Wright, professor and director of the clinical hypertension program at University Hospitals Case Medical Center in Cleveland. Concurrently with the study’s report, the SPRINT results appeared in an article published online (N Engl J Med. 2015;doi:10.1056/NEJMoa1511939).

Dr. Wright acknowledged that the more aggressive antihypertensive regimen used in SPRINT to get patients’ systolic blood pressure to a goal of less than 120 mm Hg resulted in an absolute 2.2% increased rate of serious adverse events attributable to study treatment compared with the control patients treated to a target pressure of less than 140 mm Hg, but he contended that the benefits from lower pressure outweighed this risk. Patients in the more aggressive arm required an average of 2.8 drugs/patient compared with an average of 1.8 antihypertensive drugs used by control patients. The average achieved systolic blood pressure in the aggressive arm was 121.5 mm Hg, and 134.6 mm Hg in the control arm.

Patients enrolled in SPRINT had to be at least 50 years old, have a systolic blood pressure of 130-180 mm Hg, and have an increased risk for cardiovascular disease events. That risk was defined as having at least one of these factors: clinical or subclinical cardiovascular disease other than stroke; chronic kidney disease (but excluding polycystic kidney disease) with an estimated glomerular filtration rate of 20-59 mL/min per 1.73 m2; a 10-year cardiovascular disease risk of at least 15% based on the Framingham risk score; or an age of 75 years or older. The study excluded patients with a history of stroke or diabetes.

Subgroup analyses showed consistent benefit across all subgroups including age, gender, race, the presence or absence of chronic kidney disease, and systolic blood pressure at entry. A third of patients entered the trial with a systolic blood pressure of 132 mm Hg or less. Also at baseline, 91% of enrolled patients had already been receiving antihypertensive drugs. Overall, enrolled patients were receiving an average of 1.8 antihypertensive drugs each when they entered the study.

Patients enrolled in SPRINT received treatment for an average of 3.26 years. The investigators had designed SPRINT to run for 5 years but stopped the trial sooner than planned in August when the study’s data and safety monitoring board identified clear evidence of the superiority of the more aggressive treatment that fulfilled the trials prespecified stopping criterion.

SPRINT received no commercial funding. The study received antihypertensive drugs from Arbor and Takeda at no charge for a small percentage of enrolled patients. Dr. Wright had no disclosures.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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ORLANDO – The paradigm-shifting results from the SPRINT trial showed the added benefit from a new target systolic blood-pressure goal of less than 120 mm Hg for many patients with risk factors for cardiovascular disease, but the results did not address the issue of which systolic blood pressure to use to identify patients who have hypertension and require drug intervention.

“We tested a target of less than 120 mm Hg against a target of less than 140 mm Hg; the question of whom to treat and to whom this applies” did not get tested in SPRINT (Systolic Blood Pressure Intervention Trial), Dr. Jackson T. Wright Jr. said in an interview at the American Heart Association scientific sessions.

“What the trial showed was that treating to a systolic blood pressure of less than 120 mm Hg reduced the primary, combined endpoint by [a relative] 25%, reduced all-cause mortality by [a relative] 27%, and reduced heart failure by [a relative] 38%” compared with patients treated to a target systolic pressure of less than 140 mm Hg, said Dr. Wright, professor and director of the clinical hypertension program at University Hospitals Case Medical Center in Cleveland. Concurrently with the study’s report, the SPRINT results appeared in an article published online (N Engl J Med. 2015;doi:10.1056/NEJMoa1511939).

Dr. Wright acknowledged that the more aggressive antihypertensive regimen used in SPRINT to get patients’ systolic blood pressure to a goal of less than 120 mm Hg resulted in an absolute 2.2% increased rate of serious adverse events attributable to study treatment compared with the control patients treated to a target pressure of less than 140 mm Hg, but he contended that the benefits from lower pressure outweighed this risk. Patients in the more aggressive arm required an average of 2.8 drugs/patient compared with an average of 1.8 antihypertensive drugs used by control patients. The average achieved systolic blood pressure in the aggressive arm was 121.5 mm Hg, and 134.6 mm Hg in the control arm.

Patients enrolled in SPRINT had to be at least 50 years old, have a systolic blood pressure of 130-180 mm Hg, and have an increased risk for cardiovascular disease events. That risk was defined as having at least one of these factors: clinical or subclinical cardiovascular disease other than stroke; chronic kidney disease (but excluding polycystic kidney disease) with an estimated glomerular filtration rate of 20-59 mL/min per 1.73 m2; a 10-year cardiovascular disease risk of at least 15% based on the Framingham risk score; or an age of 75 years or older. The study excluded patients with a history of stroke or diabetes.

Subgroup analyses showed consistent benefit across all subgroups including age, gender, race, the presence or absence of chronic kidney disease, and systolic blood pressure at entry. A third of patients entered the trial with a systolic blood pressure of 132 mm Hg or less. Also at baseline, 91% of enrolled patients had already been receiving antihypertensive drugs. Overall, enrolled patients were receiving an average of 1.8 antihypertensive drugs each when they entered the study.

Patients enrolled in SPRINT received treatment for an average of 3.26 years. The investigators had designed SPRINT to run for 5 years but stopped the trial sooner than planned in August when the study’s data and safety monitoring board identified clear evidence of the superiority of the more aggressive treatment that fulfilled the trials prespecified stopping criterion.

SPRINT received no commercial funding. The study received antihypertensive drugs from Arbor and Takeda at no charge for a small percentage of enrolled patients. Dr. Wright had no disclosures.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

[email protected]

On Twitter @mitchelzoler

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ORLANDO – The paradigm-shifting results from the SPRINT trial showed the added benefit from a new target systolic blood-pressure goal of less than 120 mm Hg for many patients with risk factors for cardiovascular disease, but the results did not address the issue of which systolic blood pressure to use to identify patients who have hypertension and require drug intervention.

“We tested a target of less than 120 mm Hg against a target of less than 140 mm Hg; the question of whom to treat and to whom this applies” did not get tested in SPRINT (Systolic Blood Pressure Intervention Trial), Dr. Jackson T. Wright Jr. said in an interview at the American Heart Association scientific sessions.

“What the trial showed was that treating to a systolic blood pressure of less than 120 mm Hg reduced the primary, combined endpoint by [a relative] 25%, reduced all-cause mortality by [a relative] 27%, and reduced heart failure by [a relative] 38%” compared with patients treated to a target systolic pressure of less than 140 mm Hg, said Dr. Wright, professor and director of the clinical hypertension program at University Hospitals Case Medical Center in Cleveland. Concurrently with the study’s report, the SPRINT results appeared in an article published online (N Engl J Med. 2015;doi:10.1056/NEJMoa1511939).

Dr. Wright acknowledged that the more aggressive antihypertensive regimen used in SPRINT to get patients’ systolic blood pressure to a goal of less than 120 mm Hg resulted in an absolute 2.2% increased rate of serious adverse events attributable to study treatment compared with the control patients treated to a target pressure of less than 140 mm Hg, but he contended that the benefits from lower pressure outweighed this risk. Patients in the more aggressive arm required an average of 2.8 drugs/patient compared with an average of 1.8 antihypertensive drugs used by control patients. The average achieved systolic blood pressure in the aggressive arm was 121.5 mm Hg, and 134.6 mm Hg in the control arm.

Patients enrolled in SPRINT had to be at least 50 years old, have a systolic blood pressure of 130-180 mm Hg, and have an increased risk for cardiovascular disease events. That risk was defined as having at least one of these factors: clinical or subclinical cardiovascular disease other than stroke; chronic kidney disease (but excluding polycystic kidney disease) with an estimated glomerular filtration rate of 20-59 mL/min per 1.73 m2; a 10-year cardiovascular disease risk of at least 15% based on the Framingham risk score; or an age of 75 years or older. The study excluded patients with a history of stroke or diabetes.

Subgroup analyses showed consistent benefit across all subgroups including age, gender, race, the presence or absence of chronic kidney disease, and systolic blood pressure at entry. A third of patients entered the trial with a systolic blood pressure of 132 mm Hg or less. Also at baseline, 91% of enrolled patients had already been receiving antihypertensive drugs. Overall, enrolled patients were receiving an average of 1.8 antihypertensive drugs each when they entered the study.

Patients enrolled in SPRINT received treatment for an average of 3.26 years. The investigators had designed SPRINT to run for 5 years but stopped the trial sooner than planned in August when the study’s data and safety monitoring board identified clear evidence of the superiority of the more aggressive treatment that fulfilled the trials prespecified stopping criterion.

SPRINT received no commercial funding. The study received antihypertensive drugs from Arbor and Takeda at no charge for a small percentage of enrolled patients. Dr. Wright had no disclosures.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

[email protected]

On Twitter @mitchelzoler

ORLANDO – The paradigm-shifting results from the SPRINT trial showed the added benefit from a new target systolic blood-pressure goal of less than 120 mm Hg for many patients with risk factors for cardiovascular disease, but the results did not address the issue of which systolic blood pressure to use to identify patients who have hypertension and require drug intervention.

“We tested a target of less than 120 mm Hg against a target of less than 140 mm Hg; the question of whom to treat and to whom this applies” did not get tested in SPRINT (Systolic Blood Pressure Intervention Trial), Dr. Jackson T. Wright Jr. said in an interview at the American Heart Association scientific sessions.

“What the trial showed was that treating to a systolic blood pressure of less than 120 mm Hg reduced the primary, combined endpoint by [a relative] 25%, reduced all-cause mortality by [a relative] 27%, and reduced heart failure by [a relative] 38%” compared with patients treated to a target systolic pressure of less than 140 mm Hg, said Dr. Wright, professor and director of the clinical hypertension program at University Hospitals Case Medical Center in Cleveland. Concurrently with the study’s report, the SPRINT results appeared in an article published online (N Engl J Med. 2015;doi:10.1056/NEJMoa1511939).

Dr. Wright acknowledged that the more aggressive antihypertensive regimen used in SPRINT to get patients’ systolic blood pressure to a goal of less than 120 mm Hg resulted in an absolute 2.2% increased rate of serious adverse events attributable to study treatment compared with the control patients treated to a target pressure of less than 140 mm Hg, but he contended that the benefits from lower pressure outweighed this risk. Patients in the more aggressive arm required an average of 2.8 drugs/patient compared with an average of 1.8 antihypertensive drugs used by control patients. The average achieved systolic blood pressure in the aggressive arm was 121.5 mm Hg, and 134.6 mm Hg in the control arm.

Patients enrolled in SPRINT had to be at least 50 years old, have a systolic blood pressure of 130-180 mm Hg, and have an increased risk for cardiovascular disease events. That risk was defined as having at least one of these factors: clinical or subclinical cardiovascular disease other than stroke; chronic kidney disease (but excluding polycystic kidney disease) with an estimated glomerular filtration rate of 20-59 mL/min per 1.73 m2; a 10-year cardiovascular disease risk of at least 15% based on the Framingham risk score; or an age of 75 years or older. The study excluded patients with a history of stroke or diabetes.

Subgroup analyses showed consistent benefit across all subgroups including age, gender, race, the presence or absence of chronic kidney disease, and systolic blood pressure at entry. A third of patients entered the trial with a systolic blood pressure of 132 mm Hg or less. Also at baseline, 91% of enrolled patients had already been receiving antihypertensive drugs. Overall, enrolled patients were receiving an average of 1.8 antihypertensive drugs each when they entered the study.

Patients enrolled in SPRINT received treatment for an average of 3.26 years. The investigators had designed SPRINT to run for 5 years but stopped the trial sooner than planned in August when the study’s data and safety monitoring board identified clear evidence of the superiority of the more aggressive treatment that fulfilled the trials prespecified stopping criterion.

SPRINT received no commercial funding. The study received antihypertensive drugs from Arbor and Takeda at no charge for a small percentage of enrolled patients. Dr. Wright had no disclosures.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

[email protected]

On Twitter @mitchelzoler

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AHA: Mixed results for mitral valve replacement vs. repair

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Patients undergoing mitral valve replacement had a lower risk of regurgitation and heart failure–related adverse events at 2 years than those undergoing valve repair, according to the results of a trial presented at the American Heart Association scientific sessions and published simultaneously in the New England Journal of Medicine.

The results of the trial appear to associate mitral valve replacement with clinical advantages over mitral valve repair after 2 years of follow-up. However, replacement held no significant advantages over repair in the primary endpoint of left ventricular end-systolic volume index (LVESVI) or in overall survival, said Dr. Daniel Goldstein of the department of cardiothoracic surgery at Montefiore Medical Center, New York.

In the trial conducted by the Cardiothoracic Surgical Trials Network (CTSN), 251 patients with chronic severe ischemic mitral regurgitation were randomly assigned to undergo surgical repair of the mitral valve or to receive a mitral valve replacement with a prosthetic and procedure selected at the discretion of the surgeon.

In addition to the primary endpoint of LVESVI, the two approaches were also compared for survival, regurgitation recurrence, and heart failure events.

At 2 years, the mean change from baseline in LVESVI, a measure of remodeling, did not differ significantly between the repair and replacement arms (–9.0 vs. –6.5 mL/m2, respectively). In addition, although the 2-year mortality rate was numerically lower in the repair arm relative to the replacement arm (19% vs. 23.2%, respectively), it was also not statistically different (P = .39).

However, the rate of recurrence of moderate or severe mitral regurgitation favored replacement over repair and was significant (3.8% vs. 58.8%, respectively; P less than .001). In addition, the rate of cardiovascular readmissions was significantly lower in the replacement group (P = .01).

For those in the repair group, there were significant trends for more serious adverse events related to heart failure (P = .05) and for a lower quality of life improvement (P = .07) on the Minnesota Living With Heart Failure questionnaire. There were no significant differences in rates of all serious adverse events or overall readmissions.

All of the differences between groups observed at 2 years amplify differences previously reported after 12 months (N Engl J Med. 2014 Jan 2;370[1]:23-32). For example, the difference in the rate of moderate to severe regurgitation favoring replacement over repair was already significant at that time (2.3% vs. 32.6%, respectively; P less than .001), even though the mortality rates were then, as now, numerically lower in the repair group versus the replacement group (14.3% vs. 17.6%, respectively; P = .45).

Dr. Goldstein reported no relevant financial relationships.

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Patients undergoing mitral valve replacement had a lower risk of regurgitation and heart failure–related adverse events at 2 years than those undergoing valve repair, according to the results of a trial presented at the American Heart Association scientific sessions and published simultaneously in the New England Journal of Medicine.

The results of the trial appear to associate mitral valve replacement with clinical advantages over mitral valve repair after 2 years of follow-up. However, replacement held no significant advantages over repair in the primary endpoint of left ventricular end-systolic volume index (LVESVI) or in overall survival, said Dr. Daniel Goldstein of the department of cardiothoracic surgery at Montefiore Medical Center, New York.

In the trial conducted by the Cardiothoracic Surgical Trials Network (CTSN), 251 patients with chronic severe ischemic mitral regurgitation were randomly assigned to undergo surgical repair of the mitral valve or to receive a mitral valve replacement with a prosthetic and procedure selected at the discretion of the surgeon.

In addition to the primary endpoint of LVESVI, the two approaches were also compared for survival, regurgitation recurrence, and heart failure events.

At 2 years, the mean change from baseline in LVESVI, a measure of remodeling, did not differ significantly between the repair and replacement arms (–9.0 vs. –6.5 mL/m2, respectively). In addition, although the 2-year mortality rate was numerically lower in the repair arm relative to the replacement arm (19% vs. 23.2%, respectively), it was also not statistically different (P = .39).

However, the rate of recurrence of moderate or severe mitral regurgitation favored replacement over repair and was significant (3.8% vs. 58.8%, respectively; P less than .001). In addition, the rate of cardiovascular readmissions was significantly lower in the replacement group (P = .01).

For those in the repair group, there were significant trends for more serious adverse events related to heart failure (P = .05) and for a lower quality of life improvement (P = .07) on the Minnesota Living With Heart Failure questionnaire. There were no significant differences in rates of all serious adverse events or overall readmissions.

All of the differences between groups observed at 2 years amplify differences previously reported after 12 months (N Engl J Med. 2014 Jan 2;370[1]:23-32). For example, the difference in the rate of moderate to severe regurgitation favoring replacement over repair was already significant at that time (2.3% vs. 32.6%, respectively; P less than .001), even though the mortality rates were then, as now, numerically lower in the repair group versus the replacement group (14.3% vs. 17.6%, respectively; P = .45).

Dr. Goldstein reported no relevant financial relationships.

Patients undergoing mitral valve replacement had a lower risk of regurgitation and heart failure–related adverse events at 2 years than those undergoing valve repair, according to the results of a trial presented at the American Heart Association scientific sessions and published simultaneously in the New England Journal of Medicine.

The results of the trial appear to associate mitral valve replacement with clinical advantages over mitral valve repair after 2 years of follow-up. However, replacement held no significant advantages over repair in the primary endpoint of left ventricular end-systolic volume index (LVESVI) or in overall survival, said Dr. Daniel Goldstein of the department of cardiothoracic surgery at Montefiore Medical Center, New York.

In the trial conducted by the Cardiothoracic Surgical Trials Network (CTSN), 251 patients with chronic severe ischemic mitral regurgitation were randomly assigned to undergo surgical repair of the mitral valve or to receive a mitral valve replacement with a prosthetic and procedure selected at the discretion of the surgeon.

In addition to the primary endpoint of LVESVI, the two approaches were also compared for survival, regurgitation recurrence, and heart failure events.

At 2 years, the mean change from baseline in LVESVI, a measure of remodeling, did not differ significantly between the repair and replacement arms (–9.0 vs. –6.5 mL/m2, respectively). In addition, although the 2-year mortality rate was numerically lower in the repair arm relative to the replacement arm (19% vs. 23.2%, respectively), it was also not statistically different (P = .39).

However, the rate of recurrence of moderate or severe mitral regurgitation favored replacement over repair and was significant (3.8% vs. 58.8%, respectively; P less than .001). In addition, the rate of cardiovascular readmissions was significantly lower in the replacement group (P = .01).

For those in the repair group, there were significant trends for more serious adverse events related to heart failure (P = .05) and for a lower quality of life improvement (P = .07) on the Minnesota Living With Heart Failure questionnaire. There were no significant differences in rates of all serious adverse events or overall readmissions.

All of the differences between groups observed at 2 years amplify differences previously reported after 12 months (N Engl J Med. 2014 Jan 2;370[1]:23-32). For example, the difference in the rate of moderate to severe regurgitation favoring replacement over repair was already significant at that time (2.3% vs. 32.6%, respectively; P less than .001), even though the mortality rates were then, as now, numerically lower in the repair group versus the replacement group (14.3% vs. 17.6%, respectively; P = .45).

Dr. Goldstein reported no relevant financial relationships.

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Key clinical point: Mitral valve replacement reduced regurgitation better than valve repair, but it didn’t significantly improve left ventricular function or survival.

Major finding: In patients with severe ischemic mitral regurgitation, regurgitation occurred more frequently after mitral valve repair than after valve replacement (58.8% vs. 3.8%; P less than .001), but left ventricular end-systolic volume indexes and survival rates were not significantly different.

Data source: A randomized, multicenter trial with 251 patients.

Disclosures: Dr. Goldstein reported no relevant financial relationships.

Peer support program improved cardiovascular health, tobacco cessation

Fifty-Fifty’s approach offers innovation
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A monthly peer-led support program for adults with risk factors for heart disease achieved small but significant gains in overall cardiovascular health and smoking cessation, according to a multicenter, randomized, controlled trial.

After 12 months, participants scored an average of 0.75 points higher than baseline on a novel composite measure of cardiovascular health – the Fuster-BEWAT Score (FBS) – compared with controls, reported Emilia Gómez, Ph.D., at SHE Foundation, Barcelona, Dr. Juan Miguel Fernández-Alvira of Fundación Centro Nacional de Investigaciones Cardiovasculares, Madrid, and their associates.

“Even though the magnitude of the impact of our intervention was modest, epidemiological data suggest that even very small changes in health behaviors and risk factors can significantly decrease the long-term risk of cardiovascular disease,” the investigators wrote. They presented the findings at the American Heart Association scientific sessions and simultaneously in the Journal of the American College of Cardiology.

Peer support has been used for managing various chronic diseases, but the Fifty-Fifty Program is the first multicenter, randomized trial to assess its efficacy while also accounting for baseline health education, said the investigators.

To do so, they designed a run-in of six workshops for 543 adults aged 25-50 years who had hypertension, were overweight or obese, smoked, or exercised 150 minutes or less a week. The participants, 71% of whom were female, were then randomized to receive no further support or to attend monthly, 60- to 90-minute sessions that included role playing, brainstorming, and activities focused on managing emotions, diet, and exercise. The 10 members of each group elected their own leaders, who then completed 3 hours of training in health promotion and leadership.

After 12 months, the intervention group scored an average of 8.84 (95% confidence interval, 8.37-9.32) on the FBS’ composite measure of blood pressure, exercise, weight, diet, and tobacco use, compared with 8.17 for controls (95% CI, 7.55-8.79; P = .016). The intervention group also improved 0.75 points more from baseline, compared with controls (95% CI, 0.32-1.18).

In addition, support group members scored 0.24 points higher on the 1-year measure of tobacco cessation (95% CI, 0.09-0.38; P = .003). The groups did not otherwise significantly differ in terms of individual risk factors, but the intervention group outscored the control group on measures of blood pressure, exercise, and diet.

“The results of the Fifty-Fifty study show that promoting healthier lifestyles focusing on self control of unhealthy behaviors through peer group support can be beneficial to heterogeneous groups, without a single condition or specific CV risk factors,” the researchers concluded. “Although this is a relatively short-term intervention study, follow-up results will provide insight into long-term sustainability of peer group support and long-term effect on cardiovascular health.”

The SHE Foundation and the Spanish Ministry of Health, Social Services and Equality jointly funded the research. The investigators did not report conflicts of interest.

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The Fifty-Fifty Program offers several innovations to the field of cardiovascular prevention. First, the program did not just address one risk factor, but instead emphasized multiple aspects of cardiovascular health, including health behaviors (healthy diet and increasing physical activity) and health metrics (blood pressure and body mass index) as measured by the novel risk score, the FBS. The ability of the FBS to predict clinical outcomes has not been fully validated; but all of the included measures are intimately linked to cardiovascular health and easily reproducible in other settings, since they consist of only health behaviors and non-laboratory–based health factors.

Dr. Fatima Rodriguez

Second, the Fifty-Fifty Program employed the widely used psychological interventions of peer support and group dynamics to yield modest yet positive results in CVH improvement at 1 year follow-up. Importantly, participants in the study selected the peer leaders. When interventions have this type of community buy-in, they are more likely to be successful. Finally, peer-based interventions are more likely to be self sustainable and scalable in the long term, and have wide applicability in diverse and resource-limited settings.

An important limitation of the Fifty-Fifty program was its attrition rate of 16%. Those who dropped out of the study tended to be younger and to have less favorable CVH profiles, which may have created selection bias and impacted the generalizability of the results.

Dr. Fatima Rodriguez is with the division of cardiovascular medicine, Stanford (Calif.) University. Dr. Robert Harrington is with the department of medicine, Stanford University. They reported no conflicts of interest.

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The Fifty-Fifty Program offers several innovations to the field of cardiovascular prevention. First, the program did not just address one risk factor, but instead emphasized multiple aspects of cardiovascular health, including health behaviors (healthy diet and increasing physical activity) and health metrics (blood pressure and body mass index) as measured by the novel risk score, the FBS. The ability of the FBS to predict clinical outcomes has not been fully validated; but all of the included measures are intimately linked to cardiovascular health and easily reproducible in other settings, since they consist of only health behaviors and non-laboratory–based health factors.

Dr. Fatima Rodriguez

Second, the Fifty-Fifty Program employed the widely used psychological interventions of peer support and group dynamics to yield modest yet positive results in CVH improvement at 1 year follow-up. Importantly, participants in the study selected the peer leaders. When interventions have this type of community buy-in, they are more likely to be successful. Finally, peer-based interventions are more likely to be self sustainable and scalable in the long term, and have wide applicability in diverse and resource-limited settings.

An important limitation of the Fifty-Fifty program was its attrition rate of 16%. Those who dropped out of the study tended to be younger and to have less favorable CVH profiles, which may have created selection bias and impacted the generalizability of the results.

Dr. Fatima Rodriguez is with the division of cardiovascular medicine, Stanford (Calif.) University. Dr. Robert Harrington is with the department of medicine, Stanford University. They reported no conflicts of interest.

Body

The Fifty-Fifty Program offers several innovations to the field of cardiovascular prevention. First, the program did not just address one risk factor, but instead emphasized multiple aspects of cardiovascular health, including health behaviors (healthy diet and increasing physical activity) and health metrics (blood pressure and body mass index) as measured by the novel risk score, the FBS. The ability of the FBS to predict clinical outcomes has not been fully validated; but all of the included measures are intimately linked to cardiovascular health and easily reproducible in other settings, since they consist of only health behaviors and non-laboratory–based health factors.

Dr. Fatima Rodriguez

Second, the Fifty-Fifty Program employed the widely used psychological interventions of peer support and group dynamics to yield modest yet positive results in CVH improvement at 1 year follow-up. Importantly, participants in the study selected the peer leaders. When interventions have this type of community buy-in, they are more likely to be successful. Finally, peer-based interventions are more likely to be self sustainable and scalable in the long term, and have wide applicability in diverse and resource-limited settings.

An important limitation of the Fifty-Fifty program was its attrition rate of 16%. Those who dropped out of the study tended to be younger and to have less favorable CVH profiles, which may have created selection bias and impacted the generalizability of the results.

Dr. Fatima Rodriguez is with the division of cardiovascular medicine, Stanford (Calif.) University. Dr. Robert Harrington is with the department of medicine, Stanford University. They reported no conflicts of interest.

Title
Fifty-Fifty’s approach offers innovation
Fifty-Fifty’s approach offers innovation

A monthly peer-led support program for adults with risk factors for heart disease achieved small but significant gains in overall cardiovascular health and smoking cessation, according to a multicenter, randomized, controlled trial.

After 12 months, participants scored an average of 0.75 points higher than baseline on a novel composite measure of cardiovascular health – the Fuster-BEWAT Score (FBS) – compared with controls, reported Emilia Gómez, Ph.D., at SHE Foundation, Barcelona, Dr. Juan Miguel Fernández-Alvira of Fundación Centro Nacional de Investigaciones Cardiovasculares, Madrid, and their associates.

“Even though the magnitude of the impact of our intervention was modest, epidemiological data suggest that even very small changes in health behaviors and risk factors can significantly decrease the long-term risk of cardiovascular disease,” the investigators wrote. They presented the findings at the American Heart Association scientific sessions and simultaneously in the Journal of the American College of Cardiology.

Peer support has been used for managing various chronic diseases, but the Fifty-Fifty Program is the first multicenter, randomized trial to assess its efficacy while also accounting for baseline health education, said the investigators.

To do so, they designed a run-in of six workshops for 543 adults aged 25-50 years who had hypertension, were overweight or obese, smoked, or exercised 150 minutes or less a week. The participants, 71% of whom were female, were then randomized to receive no further support or to attend monthly, 60- to 90-minute sessions that included role playing, brainstorming, and activities focused on managing emotions, diet, and exercise. The 10 members of each group elected their own leaders, who then completed 3 hours of training in health promotion and leadership.

After 12 months, the intervention group scored an average of 8.84 (95% confidence interval, 8.37-9.32) on the FBS’ composite measure of blood pressure, exercise, weight, diet, and tobacco use, compared with 8.17 for controls (95% CI, 7.55-8.79; P = .016). The intervention group also improved 0.75 points more from baseline, compared with controls (95% CI, 0.32-1.18).

In addition, support group members scored 0.24 points higher on the 1-year measure of tobacco cessation (95% CI, 0.09-0.38; P = .003). The groups did not otherwise significantly differ in terms of individual risk factors, but the intervention group outscored the control group on measures of blood pressure, exercise, and diet.

“The results of the Fifty-Fifty study show that promoting healthier lifestyles focusing on self control of unhealthy behaviors through peer group support can be beneficial to heterogeneous groups, without a single condition or specific CV risk factors,” the researchers concluded. “Although this is a relatively short-term intervention study, follow-up results will provide insight into long-term sustainability of peer group support and long-term effect on cardiovascular health.”

The SHE Foundation and the Spanish Ministry of Health, Social Services and Equality jointly funded the research. The investigators did not report conflicts of interest.

A monthly peer-led support program for adults with risk factors for heart disease achieved small but significant gains in overall cardiovascular health and smoking cessation, according to a multicenter, randomized, controlled trial.

After 12 months, participants scored an average of 0.75 points higher than baseline on a novel composite measure of cardiovascular health – the Fuster-BEWAT Score (FBS) – compared with controls, reported Emilia Gómez, Ph.D., at SHE Foundation, Barcelona, Dr. Juan Miguel Fernández-Alvira of Fundación Centro Nacional de Investigaciones Cardiovasculares, Madrid, and their associates.

“Even though the magnitude of the impact of our intervention was modest, epidemiological data suggest that even very small changes in health behaviors and risk factors can significantly decrease the long-term risk of cardiovascular disease,” the investigators wrote. They presented the findings at the American Heart Association scientific sessions and simultaneously in the Journal of the American College of Cardiology.

Peer support has been used for managing various chronic diseases, but the Fifty-Fifty Program is the first multicenter, randomized trial to assess its efficacy while also accounting for baseline health education, said the investigators.

To do so, they designed a run-in of six workshops for 543 adults aged 25-50 years who had hypertension, were overweight or obese, smoked, or exercised 150 minutes or less a week. The participants, 71% of whom were female, were then randomized to receive no further support or to attend monthly, 60- to 90-minute sessions that included role playing, brainstorming, and activities focused on managing emotions, diet, and exercise. The 10 members of each group elected their own leaders, who then completed 3 hours of training in health promotion and leadership.

After 12 months, the intervention group scored an average of 8.84 (95% confidence interval, 8.37-9.32) on the FBS’ composite measure of blood pressure, exercise, weight, diet, and tobacco use, compared with 8.17 for controls (95% CI, 7.55-8.79; P = .016). The intervention group also improved 0.75 points more from baseline, compared with controls (95% CI, 0.32-1.18).

In addition, support group members scored 0.24 points higher on the 1-year measure of tobacco cessation (95% CI, 0.09-0.38; P = .003). The groups did not otherwise significantly differ in terms of individual risk factors, but the intervention group outscored the control group on measures of blood pressure, exercise, and diet.

“The results of the Fifty-Fifty study show that promoting healthier lifestyles focusing on self control of unhealthy behaviors through peer group support can be beneficial to heterogeneous groups, without a single condition or specific CV risk factors,” the researchers concluded. “Although this is a relatively short-term intervention study, follow-up results will provide insight into long-term sustainability of peer group support and long-term effect on cardiovascular health.”

The SHE Foundation and the Spanish Ministry of Health, Social Services and Equality jointly funded the research. The investigators did not report conflicts of interest.

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Key clinical point: A peer support program was linked to significantly improved cardiovascular health, and to tobacco cessation.

Major finding: At 12 months, the mean composite cardiovascular health score was 8.84 for the intervention group, and 8.17 for controls (P = .016).

Data source: Multicenter, randomized, controlled trial of 543 adults with at least one risk factor for cardiovascular disease.

Disclosures: The SHE Foundation and the Spanish Ministry of Health, Social Services and Equality jointly funded the research. The investigators did not report conflicts of interest.

Most Women Remain Unconcerned About Heart Risk

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ORLANDO – Women’s awareness of the health risk posed by heart disease has stalled, with fully 45% of participants in a nationally representative survey being unaware that heart disease is the number-one killer of U.S. women.

The survey of 1,011 women was commissioned by the Women’s Heart Alliance. The results have provided the group with fresh ideas about how to increase awareness and motivate women to ask their physicians about their heart health, Dr. Holly S. Andersen said in an interview at the American Heart Association scientific sessions.

A key survey finding was that only 27% of women were able to name a woman in their life with heart disease. Even fewer – a mere 11% – could name a woman who has died from it. But the women who had that personal connection to heart disease were 50% more likely to describe themselves as “somewhat or very concerned” about their own risk, and they were also more likely to have asked their physicians about it.

One important strategy going forward will be to focus public education efforts on making heart disease more real and personal for women in an effort to encourage them to learn their personal risk status and take action as warranted, according to Dr. Andersen, scientific adviser to the Women’s Heart Alliance and a cardiologist at New York-Presbyterian Hospital.

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ORLANDO – Women’s awareness of the health risk posed by heart disease has stalled, with fully 45% of participants in a nationally representative survey being unaware that heart disease is the number-one killer of U.S. women.

The survey of 1,011 women was commissioned by the Women’s Heart Alliance. The results have provided the group with fresh ideas about how to increase awareness and motivate women to ask their physicians about their heart health, Dr. Holly S. Andersen said in an interview at the American Heart Association scientific sessions.

A key survey finding was that only 27% of women were able to name a woman in their life with heart disease. Even fewer – a mere 11% – could name a woman who has died from it. But the women who had that personal connection to heart disease were 50% more likely to describe themselves as “somewhat or very concerned” about their own risk, and they were also more likely to have asked their physicians about it.

One important strategy going forward will be to focus public education efforts on making heart disease more real and personal for women in an effort to encourage them to learn their personal risk status and take action as warranted, according to Dr. Andersen, scientific adviser to the Women’s Heart Alliance and a cardiologist at New York-Presbyterian Hospital.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

ORLANDO – Women’s awareness of the health risk posed by heart disease has stalled, with fully 45% of participants in a nationally representative survey being unaware that heart disease is the number-one killer of U.S. women.

The survey of 1,011 women was commissioned by the Women’s Heart Alliance. The results have provided the group with fresh ideas about how to increase awareness and motivate women to ask their physicians about their heart health, Dr. Holly S. Andersen said in an interview at the American Heart Association scientific sessions.

A key survey finding was that only 27% of women were able to name a woman in their life with heart disease. Even fewer – a mere 11% – could name a woman who has died from it. But the women who had that personal connection to heart disease were 50% more likely to describe themselves as “somewhat or very concerned” about their own risk, and they were also more likely to have asked their physicians about it.

One important strategy going forward will be to focus public education efforts on making heart disease more real and personal for women in an effort to encourage them to learn their personal risk status and take action as warranted, according to Dr. Andersen, scientific adviser to the Women’s Heart Alliance and a cardiologist at New York-Presbyterian Hospital.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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ORLANDO – Women’s awareness of the health risk posed by heart disease has stalled, with fully 45% of participants in a nationally representative survey being unaware that heart disease is the number-one killer of U.S. women.

The survey of 1,011 women was commissioned by the Women’s Heart Alliance. The results have provided the group with fresh ideas about how to increase awareness and motivate women to ask their physicians about their heart health, Dr. Holly S. Andersen said in an interview at the American Heart Association scientific sessions.

A key survey finding was that only 27% of women were able to name a woman in their life with heart disease. Even fewer – a mere 11% – could name a woman who has died from it. But the women who had that personal connection to heart disease were 50% more likely to describe themselves as “somewhat or very concerned” about their own risk, and they were also more likely to have asked their physicians about it.

One important strategy going forward will be to focus public education efforts on making heart disease more real and personal for women in an effort to encourage them to learn their personal risk status and take action as warranted, according to Dr. Andersen, scientific adviser to the Women’s Heart Alliance and a cardiologist at New York-Presbyterian Hospital.

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ORLANDO – Women’s awareness of the health risk posed by heart disease has stalled, with fully 45% of participants in a nationally representative survey being unaware that heart disease is the number-one killer of U.S. women.

The survey of 1,011 women was commissioned by the Women’s Heart Alliance. The results have provided the group with fresh ideas about how to increase awareness and motivate women to ask their physicians about their heart health, Dr. Holly S. Andersen said in an interview at the American Heart Association scientific sessions.

A key survey finding was that only 27% of women were able to name a woman in their life with heart disease. Even fewer – a mere 11% – could name a woman who has died from it. But the women who had that personal connection to heart disease were 50% more likely to describe themselves as “somewhat or very concerned” about their own risk, and they were also more likely to have asked their physicians about it.

One important strategy going forward will be to focus public education efforts on making heart disease more real and personal for women in an effort to encourage them to learn their personal risk status and take action as warranted, according to Dr. Andersen, scientific adviser to the Women’s Heart Alliance and a cardiologist at New York-Presbyterian Hospital.

[email protected]

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

ORLANDO – Women’s awareness of the health risk posed by heart disease has stalled, with fully 45% of participants in a nationally representative survey being unaware that heart disease is the number-one killer of U.S. women.

The survey of 1,011 women was commissioned by the Women’s Heart Alliance. The results have provided the group with fresh ideas about how to increase awareness and motivate women to ask their physicians about their heart health, Dr. Holly S. Andersen said in an interview at the American Heart Association scientific sessions.

A key survey finding was that only 27% of women were able to name a woman in their life with heart disease. Even fewer – a mere 11% – could name a woman who has died from it. But the women who had that personal connection to heart disease were 50% more likely to describe themselves as “somewhat or very concerned” about their own risk, and they were also more likely to have asked their physicians about it.

One important strategy going forward will be to focus public education efforts on making heart disease more real and personal for women in an effort to encourage them to learn their personal risk status and take action as warranted, according to Dr. Andersen, scientific adviser to the Women’s Heart Alliance and a cardiologist at New York-Presbyterian Hospital.

[email protected]

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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VIDEO: Most women remain unconcerned about heart risk
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