Mary Ann Moon

A diet rich in certain foods such as nuts, fish, and vegetables and low in high-fat dairy foods and red meat appears exert a preventive effect on the development of Alzheimer's disease, a study shows.

“Our findings provide support for further exploration of food-combination–based dietary behavior for the prevention of this important public health problem,” wrote Yian Gu, Ph.D., of the Taub Institute for Research in Alzheimer's Disease and the Aging Brain at Columbia University, New York, and associates.

The researchers sought to assess food combinations rather than individual nutrients in relation to Alzheimer's risk, so they studied dietary data obtained by food frequency questionnaires in two multiethnic cohorts: elderly subjects participating in the 1992 and the 1999 Washington Heights–Inwood Columbia Aging Project (WHICAP). Their study included 2,148 individuals who underwent serial batteries of neuropsychological tests, assessments of social and occupational function, and specific testing for cognitive deficits and dementia.

During an average follow-up of about 4 years, 253 of these subjects developed Alzheimer's disease. Subjects were diagnosed for dementia using the criteria developed by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association.

The investigators calculated dietary patterns based on variations in the content of seven key nutrients that have been most consistently related to dementia risk in the literature. Only one dietary pattern was found to be strongly associated with AD prevention: a diet rich in omega-3 polyunsaturated fatty acids, omega-6 polyunsaturated fatty acids, vitamin E, and folate and poor in saturated fatty acids and vitamin B₁₂.

Disclosures: This study was funded by the National Institute on Aging.

No financial conflicts of interest were reported.

The protective diet was rich in cruciferous and dark green vegetables.

Source ©Elenathewise/Fotolia.com

A diet rich in certain foods such as nuts, fish, and vegetables and low in high-fat dairy foods and red meat appears exert a preventive effect on the development of Alzheimer's disease, a study shows.

“Our findings provide support for further exploration of food-combination–based dietary behavior for the prevention of this important public health problem,” wrote Yian Gu, Ph.D., of the Taub Institute for Research in Alzheimer's Disease and the Aging Brain at Columbia University, New York, and associates.

The researchers sought to assess food combinations rather than individual nutrients in relation to Alzheimer's risk, so they studied dietary data obtained by food frequency questionnaires in two multiethnic cohorts: elderly subjects participating in the 1992 and the 1999 Washington Heights–Inwood Columbia Aging Project (WHICAP). Their study included 2,148 individuals who underwent serial batteries of neuropsychological tests, assessments of social and occupational function, and specific testing for cognitive deficits and dementia.

During an average follow-up of about 4 years, 253 of these subjects developed Alzheimer's disease. Subjects were diagnosed for dementia using the criteria developed by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association.

The investigators calculated dietary patterns based on variations in the content of seven key nutrients that have been most consistently related to dementia risk in the literature. Only one dietary pattern was found to be strongly associated with AD prevention: a diet rich in omega-3 polyunsaturated fatty acids, omega-6 polyunsaturated fatty acids, vitamin E, and folate and poor in saturated fatty acids and vitamin B₁₂.

Disclosures: This study was funded by the National Institute on Aging.

No financial conflicts of interest were reported.

The protective diet was rich in cruciferous and dark green vegetables.

Source ©Elenathewise/Fotolia.com

A diet rich in certain foods such as nuts, fish, and vegetables and low in high-fat dairy foods and red meat appears exert a preventive effect on the development of Alzheimer's disease, a study shows.

“Our findings provide support for further exploration of food-combination–based dietary behavior for the prevention of this important public health problem,” wrote Yian Gu, Ph.D., of the Taub Institute for Research in Alzheimer's Disease and the Aging Brain at Columbia University, New York, and associates.

The researchers sought to assess food combinations rather than individual nutrients in relation to Alzheimer's risk, so they studied dietary data obtained by food frequency questionnaires in two multiethnic cohorts: elderly subjects participating in the 1992 and the 1999 Washington Heights–Inwood Columbia Aging Project (WHICAP). Their study included 2,148 individuals who underwent serial batteries of neuropsychological tests, assessments of social and occupational function, and specific testing for cognitive deficits and dementia.

During an average follow-up of about 4 years, 253 of these subjects developed Alzheimer's disease. Subjects were diagnosed for dementia using the criteria developed by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association.

The investigators calculated dietary patterns based on variations in the content of seven key nutrients that have been most consistently related to dementia risk in the literature. Only one dietary pattern was found to be strongly associated with AD prevention: a diet rich in omega-3 polyunsaturated fatty acids, omega-6 polyunsaturated fatty acids, vitamin E, and folate and poor in saturated fatty acids and vitamin B₁₂.

Disclosures: This study was funded by the National Institute on Aging.

No financial conflicts of interest were reported.

The protective diet was rich in cruciferous and dark green vegetables.

Source ©Elenathewise/Fotolia.com

Major Finding: High clusterin levels were noted in 344 patients who had accelerated cognitive decline as well as in 237 subjects whose cognitive decline accelerated after their blood samples were obtained.

Data Source: Data from European centers participating in the AddNeuroMed study and the Baltimore Longitudinal Study of Aging.

Disclosures: The study was funded by the Alzheimer's Research Trust, and several other organizations. Intellectual property has been registered on the use of plasma proteins, including clusterin, for use as biomarkers for AD by King's College London and Proteome Sciences, with Dr. Thambisetty and an associate named as coinventors.

Elevated plasma levels of a protein called clusterin appear to correlate with the degree of brain atrophy, the severity of symptoms, and the speed of the clinical progression of Alzheimer's disease, a report shows.

Moreover, clusterin levels appear to rise well before symptom onset or amyloid-beta deposition is noted in the seemingly healthy brains of older patients who go on to develop Alzheimer's disease.

Raised plasma clusterin concentrations were seen 10 years before amyloid-beta deposition, suggesting that clusterin plays an etiopathological role, and is not simply a reaction to other pathology in Alzheimer's disease (AD), according to Dr. Madhav Thambisetty, who was at the King's College Institute of Psychiatry, London, when he conducted the study with his associates. He is now with the Laboratory of Personality and Cognition in the Intramural Research Program at the National Institute of Aging, Bethesda, Md.

The findings do not endorse plasma clusterin level as a stand-alone biomarker for AD. “There may well be other proteins in plasma related to the disease process, and indeed our previous studies and those of others suggest this is the case,” they said.

Previous research has suggested that clusterin is one of several extracellular “chaperones” that regulate amyloid formulation and clearance. However, studies comparing clusterin levels in cerebrospinal fluid between AD patients and control subjects have produced inconclusive results.

In their study, Dr. Thambisetty and his colleagues used plasma proteomics and neuroimaging to identify proteins that might be associated with AD.

They identified 13 spots on gel electrophoresis that correlated with hippocampal atrophy in a sample of 44 patients who had mild cognitive impairment or mild to moderate AD, then performed the same analysis in a separate sample of 51 AD patients who clearly had either slow-progressing or fast-progressing AD. Only one protein – clusterin – was common to both groups in this discovery-phase study.

The researchers then confirmed the link between clusterin and AD in a validation cohort of 689 subjects from two European studies: 464 patients with AD, 115 with mild cognitive impairment, and 110 healthy controls. This time, they correlated clusterin levels with MR imaging that showed atrophy of the entorhinal cortex, a component of the medial temporal lobe that shows early pathological changes in AD.

Plasma clusterin also negatively correlated with cognitive scores on the Mini-Mental State Examination in a subset of 576 subjects, indicating a correlation between rising clusterin and declining cognition.

Further, higher clusterin levels were noted in patients with rapid progression of AD than in those with slower progression of AD. The association was observed in 344 patients who had shown accelerated cognitive decline before their blood samples were obtained and in 237 subjects whose cognitive decline accelerated after their blood samples were obtained.

Thus, the association was evident retrospectively and prospectively, relative to the time of blood sampling.

Data from a U.S. longitudinal study of aging were used to test the hypothesis that plasma clusterin level is a marker of future AD pathology in apparently healthy older adults. The researchers found that high clusterin levels predicted AD-associated changes on PET imaging as long as 10 years before those changes were evident.

Major Finding: High clusterin levels were noted in 344 patients who had accelerated cognitive decline as well as in 237 subjects whose cognitive decline accelerated after their blood samples were obtained.

Data Source: Data from European centers participating in the AddNeuroMed study and the Baltimore Longitudinal Study of Aging.

Disclosures: The study was funded by the Alzheimer's Research Trust, and several other organizations. Intellectual property has been registered on the use of plasma proteins, including clusterin, for use as biomarkers for AD by King's College London and Proteome Sciences, with Dr. Thambisetty and an associate named as coinventors.

Elevated plasma levels of a protein called clusterin appear to correlate with the degree of brain atrophy, the severity of symptoms, and the speed of the clinical progression of Alzheimer's disease, a report shows.

Moreover, clusterin levels appear to rise well before symptom onset or amyloid-beta deposition is noted in the seemingly healthy brains of older patients who go on to develop Alzheimer's disease.

Raised plasma clusterin concentrations were seen 10 years before amyloid-beta deposition, suggesting that clusterin plays an etiopathological role, and is not simply a reaction to other pathology in Alzheimer's disease (AD), according to Dr. Madhav Thambisetty, who was at the King's College Institute of Psychiatry, London, when he conducted the study with his associates. He is now with the Laboratory of Personality and Cognition in the Intramural Research Program at the National Institute of Aging, Bethesda, Md.

The findings do not endorse plasma clusterin level as a stand-alone biomarker for AD. “There may well be other proteins in plasma related to the disease process, and indeed our previous studies and those of others suggest this is the case,” they said.

Previous research has suggested that clusterin is one of several extracellular “chaperones” that regulate amyloid formulation and clearance. However, studies comparing clusterin levels in cerebrospinal fluid between AD patients and control subjects have produced inconclusive results.

In their study, Dr. Thambisetty and his colleagues used plasma proteomics and neuroimaging to identify proteins that might be associated with AD.

They identified 13 spots on gel electrophoresis that correlated with hippocampal atrophy in a sample of 44 patients who had mild cognitive impairment or mild to moderate AD, then performed the same analysis in a separate sample of 51 AD patients who clearly had either slow-progressing or fast-progressing AD. Only one protein – clusterin – was common to both groups in this discovery-phase study.

The researchers then confirmed the link between clusterin and AD in a validation cohort of 689 subjects from two European studies: 464 patients with AD, 115 with mild cognitive impairment, and 110 healthy controls. This time, they correlated clusterin levels with MR imaging that showed atrophy of the entorhinal cortex, a component of the medial temporal lobe that shows early pathological changes in AD.

Plasma clusterin also negatively correlated with cognitive scores on the Mini-Mental State Examination in a subset of 576 subjects, indicating a correlation between rising clusterin and declining cognition.

Further, higher clusterin levels were noted in patients with rapid progression of AD than in those with slower progression of AD. The association was observed in 344 patients who had shown accelerated cognitive decline before their blood samples were obtained and in 237 subjects whose cognitive decline accelerated after their blood samples were obtained.

Thus, the association was evident retrospectively and prospectively, relative to the time of blood sampling.

Data from a U.S. longitudinal study of aging were used to test the hypothesis that plasma clusterin level is a marker of future AD pathology in apparently healthy older adults. The researchers found that high clusterin levels predicted AD-associated changes on PET imaging as long as 10 years before those changes were evident.

Major Finding: High clusterin levels were noted in 344 patients who had accelerated cognitive decline as well as in 237 subjects whose cognitive decline accelerated after their blood samples were obtained.

Data Source: Data from European centers participating in the AddNeuroMed study and the Baltimore Longitudinal Study of Aging.

Disclosures: The study was funded by the Alzheimer's Research Trust, and several other organizations. Intellectual property has been registered on the use of plasma proteins, including clusterin, for use as biomarkers for AD by King's College London and Proteome Sciences, with Dr. Thambisetty and an associate named as coinventors.

Elevated plasma levels of a protein called clusterin appear to correlate with the degree of brain atrophy, the severity of symptoms, and the speed of the clinical progression of Alzheimer's disease, a report shows.

Moreover, clusterin levels appear to rise well before symptom onset or amyloid-beta deposition is noted in the seemingly healthy brains of older patients who go on to develop Alzheimer's disease.

Raised plasma clusterin concentrations were seen 10 years before amyloid-beta deposition, suggesting that clusterin plays an etiopathological role, and is not simply a reaction to other pathology in Alzheimer's disease (AD), according to Dr. Madhav Thambisetty, who was at the King's College Institute of Psychiatry, London, when he conducted the study with his associates. He is now with the Laboratory of Personality and Cognition in the Intramural Research Program at the National Institute of Aging, Bethesda, Md.

The findings do not endorse plasma clusterin level as a stand-alone biomarker for AD. “There may well be other proteins in plasma related to the disease process, and indeed our previous studies and those of others suggest this is the case,” they said.

Previous research has suggested that clusterin is one of several extracellular “chaperones” that regulate amyloid formulation and clearance. However, studies comparing clusterin levels in cerebrospinal fluid between AD patients and control subjects have produced inconclusive results.

In their study, Dr. Thambisetty and his colleagues used plasma proteomics and neuroimaging to identify proteins that might be associated with AD.

They identified 13 spots on gel electrophoresis that correlated with hippocampal atrophy in a sample of 44 patients who had mild cognitive impairment or mild to moderate AD, then performed the same analysis in a separate sample of 51 AD patients who clearly had either slow-progressing or fast-progressing AD. Only one protein – clusterin – was common to both groups in this discovery-phase study.

The researchers then confirmed the link between clusterin and AD in a validation cohort of 689 subjects from two European studies: 464 patients with AD, 115 with mild cognitive impairment, and 110 healthy controls. This time, they correlated clusterin levels with MR imaging that showed atrophy of the entorhinal cortex, a component of the medial temporal lobe that shows early pathological changes in AD.

Plasma clusterin also negatively correlated with cognitive scores on the Mini-Mental State Examination in a subset of 576 subjects, indicating a correlation between rising clusterin and declining cognition.

Further, higher clusterin levels were noted in patients with rapid progression of AD than in those with slower progression of AD. The association was observed in 344 patients who had shown accelerated cognitive decline before their blood samples were obtained and in 237 subjects whose cognitive decline accelerated after their blood samples were obtained.

Thus, the association was evident retrospectively and prospectively, relative to the time of blood sampling.

Data from a U.S. longitudinal study of aging were used to test the hypothesis that plasma clusterin level is a marker of future AD pathology in apparently healthy older adults. The researchers found that high clusterin levels predicted AD-associated changes on PET imaging as long as 10 years before those changes were evident.

Two new genetic loci associated with Alzheimer's disease have been identified on chromosomes 2 and 19, according to researchers.

These loci will not help in identifying people at risk for AD. But they do implicate particular biological pathways that eventually could become important targets for intervention, said Dr. Sudha Seshadri of Boston University and her associates.

The researchers explored the genetics of late-onset Alzheimer's disease by performing a three-stage analysis of data accrued in several genome-wide association studies involving more than 35,000 subjects (JAMA 2010;303:1832-40).

In the first stage, they combined data from nine sources, including the Mayo AD genome-wide association study. From these sources they identified 2,708 candidate single nucleotide polymorphisms (SNPs) for further study. In the second stage of the study, Dr. Seshadri and her colleagues combined the most promising results from these genome-wide association studies and a large European data source to narrow the search to the 38 most suggestive SNPs found in 10 loci.

Finally, they combined this data with previously gathered data from the Genetic and Environmental Risk in AD 1 consortium and identified three loci already known to be associated with AD (APOE, CLU, and PICALM) as well as two novel loci on chromosomes 2 and 19.

In an editorial, Nancy L. Pedersen, Ph.D., of the Karolinska Institutet, Stockholm, said that the investigators' three-stage approach was exemplary but that considerable work would be needed to understand the “complex nexus by which these genes contribute to pathogenesis.”

Disclosures: The funding sources for this study were not available at press time. Neither Dr. Seshadri and her coauthors nor Dr. Pedersen reported conflicts of interest.

Two new genetic loci associated with Alzheimer's disease have been identified on chromosomes 2 and 19, according to researchers.

These loci will not help in identifying people at risk for AD. But they do implicate particular biological pathways that eventually could become important targets for intervention, said Dr. Sudha Seshadri of Boston University and her associates.

The researchers explored the genetics of late-onset Alzheimer's disease by performing a three-stage analysis of data accrued in several genome-wide association studies involving more than 35,000 subjects (JAMA 2010;303:1832-40).

In the first stage, they combined data from nine sources, including the Mayo AD genome-wide association study. From these sources they identified 2,708 candidate single nucleotide polymorphisms (SNPs) for further study. In the second stage of the study, Dr. Seshadri and her colleagues combined the most promising results from these genome-wide association studies and a large European data source to narrow the search to the 38 most suggestive SNPs found in 10 loci.

Finally, they combined this data with previously gathered data from the Genetic and Environmental Risk in AD 1 consortium and identified three loci already known to be associated with AD (APOE, CLU, and PICALM) as well as two novel loci on chromosomes 2 and 19.

In an editorial, Nancy L. Pedersen, Ph.D., of the Karolinska Institutet, Stockholm, said that the investigators' three-stage approach was exemplary but that considerable work would be needed to understand the “complex nexus by which these genes contribute to pathogenesis.”

Disclosures: The funding sources for this study were not available at press time. Neither Dr. Seshadri and her coauthors nor Dr. Pedersen reported conflicts of interest.

Two new genetic loci associated with Alzheimer's disease have been identified on chromosomes 2 and 19, according to researchers.

These loci will not help in identifying people at risk for AD. But they do implicate particular biological pathways that eventually could become important targets for intervention, said Dr. Sudha Seshadri of Boston University and her associates.

The researchers explored the genetics of late-onset Alzheimer's disease by performing a three-stage analysis of data accrued in several genome-wide association studies involving more than 35,000 subjects (JAMA 2010;303:1832-40).

In the first stage, they combined data from nine sources, including the Mayo AD genome-wide association study. From these sources they identified 2,708 candidate single nucleotide polymorphisms (SNPs) for further study. In the second stage of the study, Dr. Seshadri and her colleagues combined the most promising results from these genome-wide association studies and a large European data source to narrow the search to the 38 most suggestive SNPs found in 10 loci.

Finally, they combined this data with previously gathered data from the Genetic and Environmental Risk in AD 1 consortium and identified three loci already known to be associated with AD (APOE, CLU, and PICALM) as well as two novel loci on chromosomes 2 and 19.

In an editorial, Nancy L. Pedersen, Ph.D., of the Karolinska Institutet, Stockholm, said that the investigators' three-stage approach was exemplary but that considerable work would be needed to understand the “complex nexus by which these genes contribute to pathogenesis.”

Disclosures: The funding sources for this study were not available at press time. Neither Dr. Seshadri and her coauthors nor Dr. Pedersen reported conflicts of interest.

Delaying the start of school for as little as 30 minutes not only improved several measures of sleep in adolescents at a boarding school, it also improved depressive symptoms, the motivation and alertness to learn, and even some dietary habits, a study shows.

“The results of this study add to the growing literature supporting the potential benefits of adjusting school schedules to adolescents' sleep needs, circadian rhythm, and developmental stage and of optimizing sleep and alertness in the learning environment,” said Dr. Judith A. Owens of Hasbro Children's Hospital, Providence, R.I., and her associates.

They assessed the impact of delaying the school start time from 8:00 a.m. to 8:30 a.m. at a college-prep boarding and day school in southern New England for 357 students in grades 9-12. Participating students anonymously completed the 8-page Sleep Habits Survey before (225 students) and after (201 students) a 2-month trial period in which the daily class schedule was delayed for 30 minutes (Arch. Ped. Adolesc. Med. 2010;164:608-14).

The Sleep Habits Survey covers typical sleep and wake behaviors during the preceding week, sleep- and wake-behavior problems such as difficulty falling asleep and difficulty awakening, depressed mood, and daytime sleepiness under varying conditions.

After the change in school start time, students showed a significant 45-minute increase in sleep duration on school nights.

This was attributable to both waking later on school mornings and going to bed earlier on school nights.

Anecdotal comments indicated that once the adolescents perceived the benefits of getting more sleep in the mornings, they elected to go to bed earlier as well.

The proportion of students who reported that they rarely or never got enough sleep declined significantly from 69% to 34%, as did the proportion who reported that they “never” got a good night's sleep, which dropped from 29% to 12%.

The percentage of students who got fewer than 7 hours of sleep on school nights decreased markedly, from 34% to 7%. The percentage who got at least 8 hours of sleep on school nights rose substantially, from 16% to 55%.

Similarly, the study subjects' perception of their daytime sleepiness and related impairments showed highly significant improvements. The percentage of students who reported being bothered by feeling “too tired and unmotivated” to do schoolwork, socialize, or participate in sports much of the time decreased significantly.

Data from the school's health center supported the students' perception that they were less fatigued after school start time was delayed. Significantly more students visited the health center for fatigue-related symptoms before the intervention than afterward, while visits for other medical concerns showed no change.

Scores on a measure of depressed mood were significantly negatively correlated with sleep duration on both surveys. After school start time was delayed, the percentage of students who rated themselves as at least somewhat unhappy or depressed decreased significantly from 66% to 45%, as did the percentage who reported feeling irritated or annoyed much of the time (from 84% to 63%).

This benefit in depressive symptoms is particularly noteworthy, “given the recent concerns raised regarding the relationship between insufficient sleep and both depressive symptoms and suicidal ideation in adolescents,” Dr. Owens and her colleagues said.

The researchers cautioned that this study was limited in that it did not include a control group and relied on retrospective subjective self-reports rather than on objective measures of sleep variables.

Disclosures: The study was sponsored by Lifespan Hospitals of Rhode Island, a not-for-profit hospital network.

Delaying the start of school for as little as 30 minutes not only improved several measures of sleep in adolescents at a boarding school, it also improved depressive symptoms, the motivation and alertness to learn, and even some dietary habits, a study shows.

“The results of this study add to the growing literature supporting the potential benefits of adjusting school schedules to adolescents' sleep needs, circadian rhythm, and developmental stage and of optimizing sleep and alertness in the learning environment,” said Dr. Judith A. Owens of Hasbro Children's Hospital, Providence, R.I., and her associates.

They assessed the impact of delaying the school start time from 8:00 a.m. to 8:30 a.m. at a college-prep boarding and day school in southern New England for 357 students in grades 9-12. Participating students anonymously completed the 8-page Sleep Habits Survey before (225 students) and after (201 students) a 2-month trial period in which the daily class schedule was delayed for 30 minutes (Arch. Ped. Adolesc. Med. 2010;164:608-14).

The Sleep Habits Survey covers typical sleep and wake behaviors during the preceding week, sleep- and wake-behavior problems such as difficulty falling asleep and difficulty awakening, depressed mood, and daytime sleepiness under varying conditions.

After the change in school start time, students showed a significant 45-minute increase in sleep duration on school nights.

This was attributable to both waking later on school mornings and going to bed earlier on school nights.

Anecdotal comments indicated that once the adolescents perceived the benefits of getting more sleep in the mornings, they elected to go to bed earlier as well.

The proportion of students who reported that they rarely or never got enough sleep declined significantly from 69% to 34%, as did the proportion who reported that they “never” got a good night's sleep, which dropped from 29% to 12%.

The percentage of students who got fewer than 7 hours of sleep on school nights decreased markedly, from 34% to 7%. The percentage who got at least 8 hours of sleep on school nights rose substantially, from 16% to 55%.

Similarly, the study subjects' perception of their daytime sleepiness and related impairments showed highly significant improvements. The percentage of students who reported being bothered by feeling “too tired and unmotivated” to do schoolwork, socialize, or participate in sports much of the time decreased significantly.

Data from the school's health center supported the students' perception that they were less fatigued after school start time was delayed. Significantly more students visited the health center for fatigue-related symptoms before the intervention than afterward, while visits for other medical concerns showed no change.

Scores on a measure of depressed mood were significantly negatively correlated with sleep duration on both surveys. After school start time was delayed, the percentage of students who rated themselves as at least somewhat unhappy or depressed decreased significantly from 66% to 45%, as did the percentage who reported feeling irritated or annoyed much of the time (from 84% to 63%).

This benefit in depressive symptoms is particularly noteworthy, “given the recent concerns raised regarding the relationship between insufficient sleep and both depressive symptoms and suicidal ideation in adolescents,” Dr. Owens and her colleagues said.

The researchers cautioned that this study was limited in that it did not include a control group and relied on retrospective subjective self-reports rather than on objective measures of sleep variables.

Disclosures: The study was sponsored by Lifespan Hospitals of Rhode Island, a not-for-profit hospital network.

Delaying the start of school for as little as 30 minutes not only improved several measures of sleep in adolescents at a boarding school, it also improved depressive symptoms, the motivation and alertness to learn, and even some dietary habits, a study shows.

“The results of this study add to the growing literature supporting the potential benefits of adjusting school schedules to adolescents' sleep needs, circadian rhythm, and developmental stage and of optimizing sleep and alertness in the learning environment,” said Dr. Judith A. Owens of Hasbro Children's Hospital, Providence, R.I., and her associates.

They assessed the impact of delaying the school start time from 8:00 a.m. to 8:30 a.m. at a college-prep boarding and day school in southern New England for 357 students in grades 9-12. Participating students anonymously completed the 8-page Sleep Habits Survey before (225 students) and after (201 students) a 2-month trial period in which the daily class schedule was delayed for 30 minutes (Arch. Ped. Adolesc. Med. 2010;164:608-14).

The Sleep Habits Survey covers typical sleep and wake behaviors during the preceding week, sleep- and wake-behavior problems such as difficulty falling asleep and difficulty awakening, depressed mood, and daytime sleepiness under varying conditions.

After the change in school start time, students showed a significant 45-minute increase in sleep duration on school nights.

This was attributable to both waking later on school mornings and going to bed earlier on school nights.

Anecdotal comments indicated that once the adolescents perceived the benefits of getting more sleep in the mornings, they elected to go to bed earlier as well.

The proportion of students who reported that they rarely or never got enough sleep declined significantly from 69% to 34%, as did the proportion who reported that they “never” got a good night's sleep, which dropped from 29% to 12%.

The percentage of students who got fewer than 7 hours of sleep on school nights decreased markedly, from 34% to 7%. The percentage who got at least 8 hours of sleep on school nights rose substantially, from 16% to 55%.

Similarly, the study subjects' perception of their daytime sleepiness and related impairments showed highly significant improvements. The percentage of students who reported being bothered by feeling “too tired and unmotivated” to do schoolwork, socialize, or participate in sports much of the time decreased significantly.

Data from the school's health center supported the students' perception that they were less fatigued after school start time was delayed. Significantly more students visited the health center for fatigue-related symptoms before the intervention than afterward, while visits for other medical concerns showed no change.

Scores on a measure of depressed mood were significantly negatively correlated with sleep duration on both surveys. After school start time was delayed, the percentage of students who rated themselves as at least somewhat unhappy or depressed decreased significantly from 66% to 45%, as did the percentage who reported feeling irritated or annoyed much of the time (from 84% to 63%).

This benefit in depressive symptoms is particularly noteworthy, “given the recent concerns raised regarding the relationship between insufficient sleep and both depressive symptoms and suicidal ideation in adolescents,” Dr. Owens and her colleagues said.

The researchers cautioned that this study was limited in that it did not include a control group and relied on retrospective subjective self-reports rather than on objective measures of sleep variables.

Disclosures: The study was sponsored by Lifespan Hospitals of Rhode Island, a not-for-profit hospital network.

An intensive lifestyle intervention produced significant improvements in weight, cardiovascular fitness, blood pressure, hemoglobin A1c, triglycerides, and HDL-cholesterol, which were largely maintained throughout 4 years of follow-up, according to a report in the Sept. 27 issue of the Archives of Internal Medicine.

The study, involving 5,145 overweight or obese patients with type 2 diabetes, compared the intensive intervention against usual patient care, which included standard diabetes education. “Effects of the magnitude that we observed for fitness, HDL-C and HbA1c levels, and blood pressure have been associated with decreased cardiovascular events and mortality in previous medication trials and observational studies.

“The critical question is whether the differences between groups in risk factors will translate into differences in the development of CVD [cardiovascular disease]. These results will not be available for several additional years,” said Rena R. Wing, Ph.D., of the department of psychiatry at Miriam Hospital/ Brown University, Providence, R.I., and her associates in the LookAHEAD (Action for Health in Diabetes) trial.

The LookAHEAD researchers previously reported on the 1-year benefits of the intensive lifestyle intervention, compared with usual care. They now report that patients who received the intervention were able to maintain the positive changes they made for 3 more years, albeit with some degree of regression to baseline levels of all measures.

The trial enrolled subjects aged 45-76 years at 16 U.S. medical centers. Approximately 60% of the subjects were women, and 37% were from racial or ethnic minorities. The average body mass index was 36 kg/m2, and the average duration of diabetes was more than 6 years.

A total of 2,570 subjects were randomly assigned to the intensive intervention and 2,575 to usual care with diabetes education.

The intervention included dietary modification with a calorie goal of 1,200-1,800 kcal/d, less than 30% of calories from fat, and at least 15% of calories from protein. A portion-controlled diet was provided. The exercise goal was at least 175 minutes of physical activity per week at an intensity level comparable to that of brisk walking. Behavioral strategies included self-monitoring, goal setting, and problem solving.

Subjects in the intervention group met individually and in groups every week for the first 6 months and 3 times per month for the next 6 months. During years 2 through 4, they were seen individually at least once a month, contacted by phone or e-mail once a month, and attended three group sessions and assorted group classes throughout the year.

These sessions were led by registered dieticians, behavioral counselors, or exercise specialists trained in lifestyle counseling. At each session, subjects were weighed, their self-monitoring records were reviewed, and a new lesson was presented.

Complete physical assessments were performed annually, and subjects were given a $100 honorarium to encourage participation.

“Averaged across the 4 years, participants in the [intervention] group experienced greater improvements in weight, fitness, glycemic control, blood pressure, and levels of HDL-C and triglycerides than those in the [usual care] group,” Dr. Wing and her colleagues said (Arch. Intern. Med. 2010;170:1566-75).

“The mean maximal weight loss (8.6%) in the [intervention] group occurred at 1 year, but participants ... maintained a mean weight loss of 4.7% at year 4, compared with 1.1% in the [usual-care] group,” they noted.

At 1-year follow-up, cardiovascular fitness increased by 20% in the intervention group and 5% in the usual-care group. It regressed over time, but at year 4 the fitness level of the intervention group was still 5% over the baseline level, while that of the usual-care group was 1% below baseline level.

The intervention group maintained greater improvements than did the usual-care group in systolic blood pressure, HbA1c levels, and HDL-C levels, but initial improvements in diastolic blood pressure and triglycerides disappeared by year 4. There were no differences between the two groups in improvement in LDL-C levels.

“This study shows that lifestyle interventions can produce long-term weight loss and improvement in fitness and sustained beneficial effects on CVD risk factors,” the investigators said.

“Although the differences between the two groups were greatest initially and decreased over time for several measures, the differences between the groups averaged across the 4 years were substantial and indicate that the [intervention] group spent a considerable time at lower CVD risk,” they added.

“Longer follow-up will allow us to determine whether the differences between groups in CVD risk factors can be maintained and whether the [intensive intervention] has positive effects on cardiovascular morbidity and mortality,” Dr. Wing and her associates said.

Disclosures: The LookAHEAD study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases; National Heart, Lung, and Blood Institute; National Institute of Nursing Research; National Center on Minority Health and Health Disparities; Office of Research on Women’s Health; Centers for Disease Control and Prevention; U.S. Department of Veterans Affairs; Indian Health Service; and general clinical research centers at Johns Hopkins Medical Institutions, Massachusetts General Hospital, Massachusetts Institute of Technology, Colorado Health Sciences Center, University of Tennessee at Memphis, and the University of Pittsburgh. In addition, FedEx Corp., Health Management Resources, LifeScan Inc., OPTIFAST, Hoffmann-La Roche, Abbott Nutrition, and Slim-Fast have committed to make major contributions to the ongoing trial. Dr. Wing’s associates reported financial ties to BodyMedia Inc., University of Pittsburgh Medical Center Health Plan, Proctor & Gamble, and Free & Clear.

An intensive lifestyle intervention produced significant improvements in weight, cardiovascular fitness, blood pressure, hemoglobin A1c, triglycerides, and HDL-cholesterol, which were largely maintained throughout 4 years of follow-up, according to a report in the Sept. 27 issue of the Archives of Internal Medicine.

The study, involving 5,145 overweight or obese patients with type 2 diabetes, compared the intensive intervention against usual patient care, which included standard diabetes education. “Effects of the magnitude that we observed for fitness, HDL-C and HbA1c levels, and blood pressure have been associated with decreased cardiovascular events and mortality in previous medication trials and observational studies.

“The critical question is whether the differences between groups in risk factors will translate into differences in the development of CVD [cardiovascular disease]. These results will not be available for several additional years,” said Rena R. Wing, Ph.D., of the department of psychiatry at Miriam Hospital/ Brown University, Providence, R.I., and her associates in the LookAHEAD (Action for Health in Diabetes) trial.

The LookAHEAD researchers previously reported on the 1-year benefits of the intensive lifestyle intervention, compared with usual care. They now report that patients who received the intervention were able to maintain the positive changes they made for 3 more years, albeit with some degree of regression to baseline levels of all measures.

The trial enrolled subjects aged 45-76 years at 16 U.S. medical centers. Approximately 60% of the subjects were women, and 37% were from racial or ethnic minorities. The average body mass index was 36 kg/m2, and the average duration of diabetes was more than 6 years.

A total of 2,570 subjects were randomly assigned to the intensive intervention and 2,575 to usual care with diabetes education.

The intervention included dietary modification with a calorie goal of 1,200-1,800 kcal/d, less than 30% of calories from fat, and at least 15% of calories from protein. A portion-controlled diet was provided. The exercise goal was at least 175 minutes of physical activity per week at an intensity level comparable to that of brisk walking. Behavioral strategies included self-monitoring, goal setting, and problem solving.

Subjects in the intervention group met individually and in groups every week for the first 6 months and 3 times per month for the next 6 months. During years 2 through 4, they were seen individually at least once a month, contacted by phone or e-mail once a month, and attended three group sessions and assorted group classes throughout the year.

These sessions were led by registered dieticians, behavioral counselors, or exercise specialists trained in lifestyle counseling. At each session, subjects were weighed, their self-monitoring records were reviewed, and a new lesson was presented.

Complete physical assessments were performed annually, and subjects were given a $100 honorarium to encourage participation.

“Averaged across the 4 years, participants in the [intervention] group experienced greater improvements in weight, fitness, glycemic control, blood pressure, and levels of HDL-C and triglycerides than those in the [usual care] group,” Dr. Wing and her colleagues said (Arch. Intern. Med. 2010;170:1566-75).

“The mean maximal weight loss (8.6%) in the [intervention] group occurred at 1 year, but participants ... maintained a mean weight loss of 4.7% at year 4, compared with 1.1% in the [usual-care] group,” they noted.

At 1-year follow-up, cardiovascular fitness increased by 20% in the intervention group and 5% in the usual-care group. It regressed over time, but at year 4 the fitness level of the intervention group was still 5% over the baseline level, while that of the usual-care group was 1% below baseline level.

The intervention group maintained greater improvements than did the usual-care group in systolic blood pressure, HbA1c levels, and HDL-C levels, but initial improvements in diastolic blood pressure and triglycerides disappeared by year 4. There were no differences between the two groups in improvement in LDL-C levels.

“This study shows that lifestyle interventions can produce long-term weight loss and improvement in fitness and sustained beneficial effects on CVD risk factors,” the investigators said.

“Although the differences between the two groups were greatest initially and decreased over time for several measures, the differences between the groups averaged across the 4 years were substantial and indicate that the [intervention] group spent a considerable time at lower CVD risk,” they added.

“Longer follow-up will allow us to determine whether the differences between groups in CVD risk factors can be maintained and whether the [intensive intervention] has positive effects on cardiovascular morbidity and mortality,” Dr. Wing and her associates said.

Disclosures: The LookAHEAD study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases; National Heart, Lung, and Blood Institute; National Institute of Nursing Research; National Center on Minority Health and Health Disparities; Office of Research on Women’s Health; Centers for Disease Control and Prevention; U.S. Department of Veterans Affairs; Indian Health Service; and general clinical research centers at Johns Hopkins Medical Institutions, Massachusetts General Hospital, Massachusetts Institute of Technology, Colorado Health Sciences Center, University of Tennessee at Memphis, and the University of Pittsburgh. In addition, FedEx Corp., Health Management Resources, LifeScan Inc., OPTIFAST, Hoffmann-La Roche, Abbott Nutrition, and Slim-Fast have committed to make major contributions to the ongoing trial. Dr. Wing’s associates reported financial ties to BodyMedia Inc., University of Pittsburgh Medical Center Health Plan, Proctor & Gamble, and Free & Clear.

An intensive lifestyle intervention produced significant improvements in weight, cardiovascular fitness, blood pressure, hemoglobin A1c, triglycerides, and HDL-cholesterol, which were largely maintained throughout 4 years of follow-up, according to a report in the Sept. 27 issue of the Archives of Internal Medicine.

The study, involving 5,145 overweight or obese patients with type 2 diabetes, compared the intensive intervention against usual patient care, which included standard diabetes education. “Effects of the magnitude that we observed for fitness, HDL-C and HbA1c levels, and blood pressure have been associated with decreased cardiovascular events and mortality in previous medication trials and observational studies.

“The critical question is whether the differences between groups in risk factors will translate into differences in the development of CVD [cardiovascular disease]. These results will not be available for several additional years,” said Rena R. Wing, Ph.D., of the department of psychiatry at Miriam Hospital/ Brown University, Providence, R.I., and her associates in the LookAHEAD (Action for Health in Diabetes) trial.

The LookAHEAD researchers previously reported on the 1-year benefits of the intensive lifestyle intervention, compared with usual care. They now report that patients who received the intervention were able to maintain the positive changes they made for 3 more years, albeit with some degree of regression to baseline levels of all measures.

The trial enrolled subjects aged 45-76 years at 16 U.S. medical centers. Approximately 60% of the subjects were women, and 37% were from racial or ethnic minorities. The average body mass index was 36 kg/m2, and the average duration of diabetes was more than 6 years.

A total of 2,570 subjects were randomly assigned to the intensive intervention and 2,575 to usual care with diabetes education.

The intervention included dietary modification with a calorie goal of 1,200-1,800 kcal/d, less than 30% of calories from fat, and at least 15% of calories from protein. A portion-controlled diet was provided. The exercise goal was at least 175 minutes of physical activity per week at an intensity level comparable to that of brisk walking. Behavioral strategies included self-monitoring, goal setting, and problem solving.

Subjects in the intervention group met individually and in groups every week for the first 6 months and 3 times per month for the next 6 months. During years 2 through 4, they were seen individually at least once a month, contacted by phone or e-mail once a month, and attended three group sessions and assorted group classes throughout the year.

These sessions were led by registered dieticians, behavioral counselors, or exercise specialists trained in lifestyle counseling. At each session, subjects were weighed, their self-monitoring records were reviewed, and a new lesson was presented.

Complete physical assessments were performed annually, and subjects were given a $100 honorarium to encourage participation.

“Averaged across the 4 years, participants in the [intervention] group experienced greater improvements in weight, fitness, glycemic control, blood pressure, and levels of HDL-C and triglycerides than those in the [usual care] group,” Dr. Wing and her colleagues said (Arch. Intern. Med. 2010;170:1566-75).

“The mean maximal weight loss (8.6%) in the [intervention] group occurred at 1 year, but participants ... maintained a mean weight loss of 4.7% at year 4, compared with 1.1% in the [usual-care] group,” they noted.

At 1-year follow-up, cardiovascular fitness increased by 20% in the intervention group and 5% in the usual-care group. It regressed over time, but at year 4 the fitness level of the intervention group was still 5% over the baseline level, while that of the usual-care group was 1% below baseline level.

The intervention group maintained greater improvements than did the usual-care group in systolic blood pressure, HbA1c levels, and HDL-C levels, but initial improvements in diastolic blood pressure and triglycerides disappeared by year 4. There were no differences between the two groups in improvement in LDL-C levels.

“This study shows that lifestyle interventions can produce long-term weight loss and improvement in fitness and sustained beneficial effects on CVD risk factors,” the investigators said.

“Although the differences between the two groups were greatest initially and decreased over time for several measures, the differences between the groups averaged across the 4 years were substantial and indicate that the [intervention] group spent a considerable time at lower CVD risk,” they added.

“Longer follow-up will allow us to determine whether the differences between groups in CVD risk factors can be maintained and whether the [intensive intervention] has positive effects on cardiovascular morbidity and mortality,” Dr. Wing and her associates said.

Disclosures: The LookAHEAD study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases; National Heart, Lung, and Blood Institute; National Institute of Nursing Research; National Center on Minority Health and Health Disparities; Office of Research on Women’s Health; Centers for Disease Control and Prevention; U.S. Department of Veterans Affairs; Indian Health Service; and general clinical research centers at Johns Hopkins Medical Institutions, Massachusetts General Hospital, Massachusetts Institute of Technology, Colorado Health Sciences Center, University of Tennessee at Memphis, and the University of Pittsburgh. In addition, FedEx Corp., Health Management Resources, LifeScan Inc., OPTIFAST, Hoffmann-La Roche, Abbott Nutrition, and Slim-Fast have committed to make major contributions to the ongoing trial. Dr. Wing’s associates reported financial ties to BodyMedia Inc., University of Pittsburgh Medical Center Health Plan, Proctor & Gamble, and Free & Clear.

For patients with severe aortic stenosis who cannot withstand surgery, transcatheter aortic valve implantation markedly reduces mortality from any cause, cardiovascular mortality, the need for hospitalization, and cardiac symptoms, according to a report from the PARTNER trial published online Sept. 22 in the New England Journal of Medicine.

In what they described as the first multicenter randomized trial comparing transcatheter aortic valve implantation (TAVI) with standard therapy in such patients, researchers found that 1-year all-cause mortality was 20 percentage points lower with TAVI. On that basis, transfemoral “balloon-expandable TAVI should be the new standard of care for patients with [severe] aortic stenosis who are not suitable candidates for surgery,” said Dr. Martin B. Leon of Columbia University Medical Center/New York Presbyterian Hospital and his associates in the industry-funded Placement of Aortic Transcatheter Valves (PARTNER) study.

Previous studies of TAVI, which has been adopted rapidly worldwide for the treatment of severe aortic stenosis since its inception in 2002, have all been “observational registry studies, without standardization of end-point definitions (and unpublished data) and without control populations.” The PARTNER study was designed to collect rigorous, evidence-based clinical data to substantiate the procedure’s benefits, compared with current standard treatment, the investigators said.

The 358 study subjects were enrolled at 21 sites throughout the United States and in London and Vancouver in 2007-2009. Half were randomly assigned to undergo TAVI and half to receive standard therapy, and all were followed for 1-3 years.

The primary end point – death from any cause at 1 year follow-up – was 31% with TAVI and 51% with standard treatment. Cardiovascular mortality also was markedly lower with TAVI (21%) than with standard treatment (45%).The composite end point of death from any cause or repeat hospitalization within 1 year also was dramatically lower with TAVI (43%) than with standard treatment (72%).

Symptoms also were significantly reduced in the TAVI group. At 1 year, 75% of surviving patients who had undergone TAVI were asymptomatic or had only mild symptoms, compared with 42% of those who had received standard therapy, Dr. Leon and his colleagues said (N. Engl. J. Med. 2010 Sept. 22 [10.1056/NEJMoa1008232]).

Major neurologic events, vascular complications, and bleeding events were more common in the TAVI group. In particular, major stroke was more common with TAVI at 30 days (5%) and 1 year (8%) than with standard therapy (1% and 4%, respectively), but these differences did not reach statistical significance.

On echocardiography, the mean aortic-valve area increased and the mean aortic-valve gradient decreased with TAVI, both significant results that were maintained through 1-year follow-up. The incidence of moderate or severe transvalvular aortic regurgitation was 1% at 30 days and 4% at 1 year in the TAVI group, compared with 17% and 15%, respectively, with standard treatment.

“Undoubtedly, the large femoral access sheaths that are required to insert [current] TAVI system[s] contributed to the frequent occurrence of vascular complications and bleeding events. Ongoing studies are assessing the use of a lower-profile valve and support frame, which may reduce vascular complications, allow patients who have smaller iliofemoral arteries than did patients in this study to undergo this procedure, and facilitate percutaneous access and closure,” the investigators added.

The PARTNER study was sponsored by Edwards Lifesciences. Dr. Leon and his associates reported numerous ties to drug and device manufacturers including Edwards, Medtronic, Sadra Medical, Heart Leaflet Technologies, St. Jude Medical, Abbott, Lilly, Johnson and Johnson, Daiichi Sankyo, Sorin Medical, Entourage Medical Technologies, CoreValve, and Direct Flow Medical.

For patients with severe aortic stenosis who cannot withstand surgery, transcatheter aortic valve implantation markedly reduces mortality from any cause, cardiovascular mortality, the need for hospitalization, and cardiac symptoms, according to a report from the PARTNER trial published online Sept. 22 in the New England Journal of Medicine.

In what they described as the first multicenter randomized trial comparing transcatheter aortic valve implantation (TAVI) with standard therapy in such patients, researchers found that 1-year all-cause mortality was 20 percentage points lower with TAVI. On that basis, transfemoral “balloon-expandable TAVI should be the new standard of care for patients with [severe] aortic stenosis who are not suitable candidates for surgery,” said Dr. Martin B. Leon of Columbia University Medical Center/New York Presbyterian Hospital and his associates in the industry-funded Placement of Aortic Transcatheter Valves (PARTNER) study.

Previous studies of TAVI, which has been adopted rapidly worldwide for the treatment of severe aortic stenosis since its inception in 2002, have all been “observational registry studies, without standardization of end-point definitions (and unpublished data) and without control populations.” The PARTNER study was designed to collect rigorous, evidence-based clinical data to substantiate the procedure’s benefits, compared with current standard treatment, the investigators said.

The 358 study subjects were enrolled at 21 sites throughout the United States and in London and Vancouver in 2007-2009. Half were randomly assigned to undergo TAVI and half to receive standard therapy, and all were followed for 1-3 years.

The primary end point – death from any cause at 1 year follow-up – was 31% with TAVI and 51% with standard treatment. Cardiovascular mortality also was markedly lower with TAVI (21%) than with standard treatment (45%).The composite end point of death from any cause or repeat hospitalization within 1 year also was dramatically lower with TAVI (43%) than with standard treatment (72%).

Symptoms also were significantly reduced in the TAVI group. At 1 year, 75% of surviving patients who had undergone TAVI were asymptomatic or had only mild symptoms, compared with 42% of those who had received standard therapy, Dr. Leon and his colleagues said (N. Engl. J. Med. 2010 Sept. 22 [10.1056/NEJMoa1008232]).

Major neurologic events, vascular complications, and bleeding events were more common in the TAVI group. In particular, major stroke was more common with TAVI at 30 days (5%) and 1 year (8%) than with standard therapy (1% and 4%, respectively), but these differences did not reach statistical significance.

On echocardiography, the mean aortic-valve area increased and the mean aortic-valve gradient decreased with TAVI, both significant results that were maintained through 1-year follow-up. The incidence of moderate or severe transvalvular aortic regurgitation was 1% at 30 days and 4% at 1 year in the TAVI group, compared with 17% and 15%, respectively, with standard treatment.

“Undoubtedly, the large femoral access sheaths that are required to insert [current] TAVI system[s] contributed to the frequent occurrence of vascular complications and bleeding events. Ongoing studies are assessing the use of a lower-profile valve and support frame, which may reduce vascular complications, allow patients who have smaller iliofemoral arteries than did patients in this study to undergo this procedure, and facilitate percutaneous access and closure,” the investigators added.

The PARTNER study was sponsored by Edwards Lifesciences. Dr. Leon and his associates reported numerous ties to drug and device manufacturers including Edwards, Medtronic, Sadra Medical, Heart Leaflet Technologies, St. Jude Medical, Abbott, Lilly, Johnson and Johnson, Daiichi Sankyo, Sorin Medical, Entourage Medical Technologies, CoreValve, and Direct Flow Medical.

For patients with severe aortic stenosis who cannot withstand surgery, transcatheter aortic valve implantation markedly reduces mortality from any cause, cardiovascular mortality, the need for hospitalization, and cardiac symptoms, according to a report from the PARTNER trial published online Sept. 22 in the New England Journal of Medicine.

In what they described as the first multicenter randomized trial comparing transcatheter aortic valve implantation (TAVI) with standard therapy in such patients, researchers found that 1-year all-cause mortality was 20 percentage points lower with TAVI. On that basis, transfemoral “balloon-expandable TAVI should be the new standard of care for patients with [severe] aortic stenosis who are not suitable candidates for surgery,” said Dr. Martin B. Leon of Columbia University Medical Center/New York Presbyterian Hospital and his associates in the industry-funded Placement of Aortic Transcatheter Valves (PARTNER) study.

Previous studies of TAVI, which has been adopted rapidly worldwide for the treatment of severe aortic stenosis since its inception in 2002, have all been “observational registry studies, without standardization of end-point definitions (and unpublished data) and without control populations.” The PARTNER study was designed to collect rigorous, evidence-based clinical data to substantiate the procedure’s benefits, compared with current standard treatment, the investigators said.

The 358 study subjects were enrolled at 21 sites throughout the United States and in London and Vancouver in 2007-2009. Half were randomly assigned to undergo TAVI and half to receive standard therapy, and all were followed for 1-3 years.

The primary end point – death from any cause at 1 year follow-up – was 31% with TAVI and 51% with standard treatment. Cardiovascular mortality also was markedly lower with TAVI (21%) than with standard treatment (45%).The composite end point of death from any cause or repeat hospitalization within 1 year also was dramatically lower with TAVI (43%) than with standard treatment (72%).

Symptoms also were significantly reduced in the TAVI group. At 1 year, 75% of surviving patients who had undergone TAVI were asymptomatic or had only mild symptoms, compared with 42% of those who had received standard therapy, Dr. Leon and his colleagues said (N. Engl. J. Med. 2010 Sept. 22 [10.1056/NEJMoa1008232]).

Major neurologic events, vascular complications, and bleeding events were more common in the TAVI group. In particular, major stroke was more common with TAVI at 30 days (5%) and 1 year (8%) than with standard therapy (1% and 4%, respectively), but these differences did not reach statistical significance.

On echocardiography, the mean aortic-valve area increased and the mean aortic-valve gradient decreased with TAVI, both significant results that were maintained through 1-year follow-up. The incidence of moderate or severe transvalvular aortic regurgitation was 1% at 30 days and 4% at 1 year in the TAVI group, compared with 17% and 15%, respectively, with standard treatment.

“Undoubtedly, the large femoral access sheaths that are required to insert [current] TAVI system[s] contributed to the frequent occurrence of vascular complications and bleeding events. Ongoing studies are assessing the use of a lower-profile valve and support frame, which may reduce vascular complications, allow patients who have smaller iliofemoral arteries than did patients in this study to undergo this procedure, and facilitate percutaneous access and closure,” the investigators added.

The PARTNER study was sponsored by Edwards Lifesciences. Dr. Leon and his associates reported numerous ties to drug and device manufacturers including Edwards, Medtronic, Sadra Medical, Heart Leaflet Technologies, St. Jude Medical, Abbott, Lilly, Johnson and Johnson, Daiichi Sankyo, Sorin Medical, Entourage Medical Technologies, CoreValve, and Direct Flow Medical.

Unilateral lobar treatment with endobronchial valves produces modest improvements in lung function, exercise tolerance, and symptoms in patients with advanced, heterogenous, hyperinflated emphysema, according to a report in the Sept. 23 issue of the New England Journal of Medicine.

However, these benefits come with substantial costs in the months following implantation: more frequent exacerbations of chronic obstructive pulmonary disease (COPD), pneumonia distal to the valves in more than 4% of cases, hemoptysis related to oozing from granulation tissue, and pneumothorax, said Dr. Frank C. Sciurba of the University of Pittsburgh and his associates.

They assessed the safety and efficacy of endobronchial valves, compared with standard medical care, in what they described as the first randomized, prospective, multicenter study of the devices, the Endobronchial Valve for Emphysema Palliation Trial (VENT).

The study involved 321 patients (aged 40-75 years) who were randomly assigned to receive either the unidirectional valves (220 subjects), which block regional inflation while allowing exhalation, or standard medical therapy (101 controls).

The valves are designed to reduce the volume (hyperinflation) of the most severely damaged lobe, allowing expansion of the more viable adjacent lobe.

A mean of 3.8 valves was placed in each patient via bronchoscopy. The valves were placed in only one lung (in the lobar, segmental, or subsegmental bronchi, depending on the patient’s anatomy) to completely isolate the targeted lobe. Moderate sedation was used in 71% of patients and general anesthesia in 29%. The mean duration of the procedure was 34 minutes.

The composite efficacy end point was the percent change in FEV1 and distance achieved in the 6-minute walk test at the 6-month follow-up. The primary safety end point was a composite of six major complications arising within 6 months: death, empyema, massive hemoptysis, pneumonia distal to the valves, pneumothorax or air leak of more than 7 days’ duration, or ventilator-dependent respiratory failure of more than 24 hours’ duration.

Quality of life, exercise capacity, dyspnea, and daily oxygen use also were assessed as secondary end points.

At 6 months, FEV1 increased by 4.3% in the valve group and decreased by 2.5% in control group, for a mean between-group difference of 6.8%. Similarly, distance traveled in the 6-minute walk test increased by 2.5% in the valve group and decreased by 3.2% in the control group, for a mean between-group difference of 5.8%, Dr. Sciurba and his colleagues reported (N. Engl. J. Med. 2010;363:1233-44).

Patients who received the valves also showed modest changes in all secondary end points.

However, the 6-month rate of composite complications was 6.1% in the valve group, compared with 1.2% in the control group. This included six deaths in the valve group and none in the control group. At 1 year, the complication rates were 10.3% and 4.6%, respectively.

The most common adverse event related to valve placement was pneumonia distal to the valve, which developed in 4.2% of patients within 1 year of the procedure. Hemoptysis requiring bronchoscopic inspection was significantly more common in the valve group (approximately 12%) than in controls (0%). Similarly, pneumothorax developed more often in the valve group (5.2%) than in controls (2.4%), as did COPD exacerbations requiring hospitalization (7.9% and 1.1%, respectively).

“In 12 months of follow-up, valves were removed in 31 patients for reasons including retrieval of a migrated valve (in 8 patients), the patient’s request for an unspecified reason (in 7), pneumonia management (in 3), COPD exacerbations (in 2), hemoptysis (in 1), and other reasons (in 7),” the researchers said. In addition, further bronchoscopies were required in 23% of the valve group, compared with only 1% of the control group.

After the trial was completed in 2007, an additional eight patients underwent elective removal of the valves because of adverse events, and three others experienced spontaneous expectoration of a valve, the investigators said.

The VENT study was funded by Emphasys Medical (now Pulmonx) and a grant to Dr. Sciurba from the National Institutes of Health. Dr. Sciurba and several associates reported ties to numerous drug and device manufacturers.

Unilateral lobar treatment with endobronchial valves produces modest improvements in lung function, exercise tolerance, and symptoms in patients with advanced, heterogenous, hyperinflated emphysema, according to a report in the Sept. 23 issue of the New England Journal of Medicine.

However, these benefits come with substantial costs in the months following implantation: more frequent exacerbations of chronic obstructive pulmonary disease (COPD), pneumonia distal to the valves in more than 4% of cases, hemoptysis related to oozing from granulation tissue, and pneumothorax, said Dr. Frank C. Sciurba of the University of Pittsburgh and his associates.

They assessed the safety and efficacy of endobronchial valves, compared with standard medical care, in what they described as the first randomized, prospective, multicenter study of the devices, the Endobronchial Valve for Emphysema Palliation Trial (VENT).

The study involved 321 patients (aged 40-75 years) who were randomly assigned to receive either the unidirectional valves (220 subjects), which block regional inflation while allowing exhalation, or standard medical therapy (101 controls).

The valves are designed to reduce the volume (hyperinflation) of the most severely damaged lobe, allowing expansion of the more viable adjacent lobe.

A mean of 3.8 valves was placed in each patient via bronchoscopy. The valves were placed in only one lung (in the lobar, segmental, or subsegmental bronchi, depending on the patient’s anatomy) to completely isolate the targeted lobe. Moderate sedation was used in 71% of patients and general anesthesia in 29%. The mean duration of the procedure was 34 minutes.

The composite efficacy end point was the percent change in FEV1 and distance achieved in the 6-minute walk test at the 6-month follow-up. The primary safety end point was a composite of six major complications arising within 6 months: death, empyema, massive hemoptysis, pneumonia distal to the valves, pneumothorax or air leak of more than 7 days’ duration, or ventilator-dependent respiratory failure of more than 24 hours’ duration.

Quality of life, exercise capacity, dyspnea, and daily oxygen use also were assessed as secondary end points.

At 6 months, FEV1 increased by 4.3% in the valve group and decreased by 2.5% in control group, for a mean between-group difference of 6.8%. Similarly, distance traveled in the 6-minute walk test increased by 2.5% in the valve group and decreased by 3.2% in the control group, for a mean between-group difference of 5.8%, Dr. Sciurba and his colleagues reported (N. Engl. J. Med. 2010;363:1233-44).

Patients who received the valves also showed modest changes in all secondary end points.

However, the 6-month rate of composite complications was 6.1% in the valve group, compared with 1.2% in the control group. This included six deaths in the valve group and none in the control group. At 1 year, the complication rates were 10.3% and 4.6%, respectively.

The most common adverse event related to valve placement was pneumonia distal to the valve, which developed in 4.2% of patients within 1 year of the procedure. Hemoptysis requiring bronchoscopic inspection was significantly more common in the valve group (approximately 12%) than in controls (0%). Similarly, pneumothorax developed more often in the valve group (5.2%) than in controls (2.4%), as did COPD exacerbations requiring hospitalization (7.9% and 1.1%, respectively).

“In 12 months of follow-up, valves were removed in 31 patients for reasons including retrieval of a migrated valve (in 8 patients), the patient’s request for an unspecified reason (in 7), pneumonia management (in 3), COPD exacerbations (in 2), hemoptysis (in 1), and other reasons (in 7),” the researchers said. In addition, further bronchoscopies were required in 23% of the valve group, compared with only 1% of the control group.

After the trial was completed in 2007, an additional eight patients underwent elective removal of the valves because of adverse events, and three others experienced spontaneous expectoration of a valve, the investigators said.

The VENT study was funded by Emphasys Medical (now Pulmonx) and a grant to Dr. Sciurba from the National Institutes of Health. Dr. Sciurba and several associates reported ties to numerous drug and device manufacturers.

Unilateral lobar treatment with endobronchial valves produces modest improvements in lung function, exercise tolerance, and symptoms in patients with advanced, heterogenous, hyperinflated emphysema, according to a report in the Sept. 23 issue of the New England Journal of Medicine.

However, these benefits come with substantial costs in the months following implantation: more frequent exacerbations of chronic obstructive pulmonary disease (COPD), pneumonia distal to the valves in more than 4% of cases, hemoptysis related to oozing from granulation tissue, and pneumothorax, said Dr. Frank C. Sciurba of the University of Pittsburgh and his associates.

They assessed the safety and efficacy of endobronchial valves, compared with standard medical care, in what they described as the first randomized, prospective, multicenter study of the devices, the Endobronchial Valve for Emphysema Palliation Trial (VENT).

The study involved 321 patients (aged 40-75 years) who were randomly assigned to receive either the unidirectional valves (220 subjects), which block regional inflation while allowing exhalation, or standard medical therapy (101 controls).

The valves are designed to reduce the volume (hyperinflation) of the most severely damaged lobe, allowing expansion of the more viable adjacent lobe.

A mean of 3.8 valves was placed in each patient via bronchoscopy. The valves were placed in only one lung (in the lobar, segmental, or subsegmental bronchi, depending on the patient’s anatomy) to completely isolate the targeted lobe. Moderate sedation was used in 71% of patients and general anesthesia in 29%. The mean duration of the procedure was 34 minutes.

The composite efficacy end point was the percent change in FEV1 and distance achieved in the 6-minute walk test at the 6-month follow-up. The primary safety end point was a composite of six major complications arising within 6 months: death, empyema, massive hemoptysis, pneumonia distal to the valves, pneumothorax or air leak of more than 7 days’ duration, or ventilator-dependent respiratory failure of more than 24 hours’ duration.

Quality of life, exercise capacity, dyspnea, and daily oxygen use also were assessed as secondary end points.

At 6 months, FEV1 increased by 4.3% in the valve group and decreased by 2.5% in control group, for a mean between-group difference of 6.8%. Similarly, distance traveled in the 6-minute walk test increased by 2.5% in the valve group and decreased by 3.2% in the control group, for a mean between-group difference of 5.8%, Dr. Sciurba and his colleagues reported (N. Engl. J. Med. 2010;363:1233-44).

Patients who received the valves also showed modest changes in all secondary end points.

However, the 6-month rate of composite complications was 6.1% in the valve group, compared with 1.2% in the control group. This included six deaths in the valve group and none in the control group. At 1 year, the complication rates were 10.3% and 4.6%, respectively.

The most common adverse event related to valve placement was pneumonia distal to the valve, which developed in 4.2% of patients within 1 year of the procedure. Hemoptysis requiring bronchoscopic inspection was significantly more common in the valve group (approximately 12%) than in controls (0%). Similarly, pneumothorax developed more often in the valve group (5.2%) than in controls (2.4%), as did COPD exacerbations requiring hospitalization (7.9% and 1.1%, respectively).

“In 12 months of follow-up, valves were removed in 31 patients for reasons including retrieval of a migrated valve (in 8 patients), the patient’s request for an unspecified reason (in 7), pneumonia management (in 3), COPD exacerbations (in 2), hemoptysis (in 1), and other reasons (in 7),” the researchers said. In addition, further bronchoscopies were required in 23% of the valve group, compared with only 1% of the control group.

After the trial was completed in 2007, an additional eight patients underwent elective removal of the valves because of adverse events, and three others experienced spontaneous expectoration of a valve, the investigators said.

The VENT study was funded by Emphasys Medical (now Pulmonx) and a grant to Dr. Sciurba from the National Institutes of Health. Dr. Sciurba and several associates reported ties to numerous drug and device manufacturers.

An intervention to teach patients self-management of their chronic heart failure failed to reduce mortality or hospitalizations for the disorder, compared with patient education alone, according to a report in the Sept. 22/29 issue of JAMA.

Nonadherence to heart failure medications ranges from 30% to 60%, and nonadherence to lifestyle recommendations ranges from 50% to 80% in the general population. Previous assessments of self-management techniques to improve adherence have been limited by their small sample sizes, short durations, and inadequate follow-up time, said Lynda H. Powell, Ph.D., of the department of preventive medicine at Rush University Medical Center, Chicago, and her associates.

The investigators designed HART (Heart Failure Adherence and Retention Trial) to have the size, duration, methodologic rigor, and representation of typical HF patients so that it would provide more conclusive results. They assessed mortality and HF hospitalizations after 1 year of self-management counseling and another 1-2 years of follow-up in 902 patients with mild to moderate HF who were recruited at 10 hospitals throughout Chicago.

In all, 451 patients (average age, 64 years) were randomly assigned to receive the study intervention, and the other 451 served as a control group.

Slightly fewer than half of the study subjects were women, and 40% were members of racial/ethnic minority groups. Overall, 23% had preserved systolic function and the remainder had impaired systolic function, making the sample “representative of typical clinical populations.”

At baseline, patients were taking an average of seven medications. Nearly 40% did not adhere to the prescribed dosage of either an ACE inhibitor or a beta-blocker. Median sodium intake was almost twice as high as is recommended for HF patients, and depressive symptoms were evident in nearly 40%.

The study intervention included 18 2-hour group meetings over the course of a year. Patients were educated about medication adherence, sudden weight gain, sodium restriction, moderate physical activity, and stress management, and were given American Heart Association tip sheets concerning HF. The program also included counseling “to help patients develop mastery in problem-solving skills” as well as in five self-management skills: self-monitoring, environmental restructuring, elicitation of support from family and friends, cognitive restructuring, and the relaxation response.

The control group received the AHA tip sheets by mail, and discussed the material by phone with study counselors.

The intervention did not improve the primary end point, which was hospitalization for HF events or death. There were 163 events in the intervention group (40%) and 171 in the control group (41%), a nonsignificant difference. The annual event rate was 18% in the intervention group and 19% in the control group, also a nonsignificant difference.

Patients in both study groups had a mean of 0.7 HF hospitalizations. At the conclusion of the study, there were no differences between the two groups in 6-minute walk times, change in New York Heart Association class, heart rate, respiratory rate, blood pressure, or body mass index. There also were no differences in several measures of quality of life.

Moreover, nonadherence to prescribed ACE inhibitor or beta-blocker therapy had risen by 7% in both groups, Dr. Powell and her colleagues said (JAMA 2010;304:1331-8).

The researchers also performed a post hoc analysis of outcomes in nine subgroups of patients, categorizing patients by age, ethnicity, NYHA class, presence or absence of depressive symptoms, education level, annual income, and presence or absence of three or more comorbid conditions. Only one of these variables – a low annual income – correlated with improved outcomes in subjects who participated in the self-management intervention, compared with control subjects. This suggests that the intervention may be beneficial in low-income patients with HF, the investigators said.

HART was funded by the National Institutes of Health. An associate of Dr. Powell reported receiving research funding from Novartis after HART was concluded.

An intervention to teach patients self-management of their chronic heart failure failed to reduce mortality or hospitalizations for the disorder, compared with patient education alone, according to a report in the Sept. 22/29 issue of JAMA.

Nonadherence to heart failure medications ranges from 30% to 60%, and nonadherence to lifestyle recommendations ranges from 50% to 80% in the general population. Previous assessments of self-management techniques to improve adherence have been limited by their small sample sizes, short durations, and inadequate follow-up time, said Lynda H. Powell, Ph.D., of the department of preventive medicine at Rush University Medical Center, Chicago, and her associates.

The investigators designed HART (Heart Failure Adherence and Retention Trial) to have the size, duration, methodologic rigor, and representation of typical HF patients so that it would provide more conclusive results. They assessed mortality and HF hospitalizations after 1 year of self-management counseling and another 1-2 years of follow-up in 902 patients with mild to moderate HF who were recruited at 10 hospitals throughout Chicago.

In all, 451 patients (average age, 64 years) were randomly assigned to receive the study intervention, and the other 451 served as a control group.

Slightly fewer than half of the study subjects were women, and 40% were members of racial/ethnic minority groups. Overall, 23% had preserved systolic function and the remainder had impaired systolic function, making the sample “representative of typical clinical populations.”

At baseline, patients were taking an average of seven medications. Nearly 40% did not adhere to the prescribed dosage of either an ACE inhibitor or a beta-blocker. Median sodium intake was almost twice as high as is recommended for HF patients, and depressive symptoms were evident in nearly 40%.

The study intervention included 18 2-hour group meetings over the course of a year. Patients were educated about medication adherence, sudden weight gain, sodium restriction, moderate physical activity, and stress management, and were given American Heart Association tip sheets concerning HF. The program also included counseling “to help patients develop mastery in problem-solving skills” as well as in five self-management skills: self-monitoring, environmental restructuring, elicitation of support from family and friends, cognitive restructuring, and the relaxation response.

The control group received the AHA tip sheets by mail, and discussed the material by phone with study counselors.

The intervention did not improve the primary end point, which was hospitalization for HF events or death. There were 163 events in the intervention group (40%) and 171 in the control group (41%), a nonsignificant difference. The annual event rate was 18% in the intervention group and 19% in the control group, also a nonsignificant difference.

Patients in both study groups had a mean of 0.7 HF hospitalizations. At the conclusion of the study, there were no differences between the two groups in 6-minute walk times, change in New York Heart Association class, heart rate, respiratory rate, blood pressure, or body mass index. There also were no differences in several measures of quality of life.

Moreover, nonadherence to prescribed ACE inhibitor or beta-blocker therapy had risen by 7% in both groups, Dr. Powell and her colleagues said (JAMA 2010;304:1331-8).

The researchers also performed a post hoc analysis of outcomes in nine subgroups of patients, categorizing patients by age, ethnicity, NYHA class, presence or absence of depressive symptoms, education level, annual income, and presence or absence of three or more comorbid conditions. Only one of these variables – a low annual income – correlated with improved outcomes in subjects who participated in the self-management intervention, compared with control subjects. This suggests that the intervention may be beneficial in low-income patients with HF, the investigators said.

HART was funded by the National Institutes of Health. An associate of Dr. Powell reported receiving research funding from Novartis after HART was concluded.

An intervention to teach patients self-management of their chronic heart failure failed to reduce mortality or hospitalizations for the disorder, compared with patient education alone, according to a report in the Sept. 22/29 issue of JAMA.

Nonadherence to heart failure medications ranges from 30% to 60%, and nonadherence to lifestyle recommendations ranges from 50% to 80% in the general population. Previous assessments of self-management techniques to improve adherence have been limited by their small sample sizes, short durations, and inadequate follow-up time, said Lynda H. Powell, Ph.D., of the department of preventive medicine at Rush University Medical Center, Chicago, and her associates.

The investigators designed HART (Heart Failure Adherence and Retention Trial) to have the size, duration, methodologic rigor, and representation of typical HF patients so that it would provide more conclusive results. They assessed mortality and HF hospitalizations after 1 year of self-management counseling and another 1-2 years of follow-up in 902 patients with mild to moderate HF who were recruited at 10 hospitals throughout Chicago.

In all, 451 patients (average age, 64 years) were randomly assigned to receive the study intervention, and the other 451 served as a control group.

Slightly fewer than half of the study subjects were women, and 40% were members of racial/ethnic minority groups. Overall, 23% had preserved systolic function and the remainder had impaired systolic function, making the sample “representative of typical clinical populations.”

At baseline, patients were taking an average of seven medications. Nearly 40% did not adhere to the prescribed dosage of either an ACE inhibitor or a beta-blocker. Median sodium intake was almost twice as high as is recommended for HF patients, and depressive symptoms were evident in nearly 40%.

The study intervention included 18 2-hour group meetings over the course of a year. Patients were educated about medication adherence, sudden weight gain, sodium restriction, moderate physical activity, and stress management, and were given American Heart Association tip sheets concerning HF. The program also included counseling “to help patients develop mastery in problem-solving skills” as well as in five self-management skills: self-monitoring, environmental restructuring, elicitation of support from family and friends, cognitive restructuring, and the relaxation response.

The control group received the AHA tip sheets by mail, and discussed the material by phone with study counselors.

The intervention did not improve the primary end point, which was hospitalization for HF events or death. There were 163 events in the intervention group (40%) and 171 in the control group (41%), a nonsignificant difference. The annual event rate was 18% in the intervention group and 19% in the control group, also a nonsignificant difference.

Patients in both study groups had a mean of 0.7 HF hospitalizations. At the conclusion of the study, there were no differences between the two groups in 6-minute walk times, change in New York Heart Association class, heart rate, respiratory rate, blood pressure, or body mass index. There also were no differences in several measures of quality of life.

Moreover, nonadherence to prescribed ACE inhibitor or beta-blocker therapy had risen by 7% in both groups, Dr. Powell and her colleagues said (JAMA 2010;304:1331-8).

The researchers also performed a post hoc analysis of outcomes in nine subgroups of patients, categorizing patients by age, ethnicity, NYHA class, presence or absence of depressive symptoms, education level, annual income, and presence or absence of three or more comorbid conditions. Only one of these variables – a low annual income – correlated with improved outcomes in subjects who participated in the self-management intervention, compared with control subjects. This suggests that the intervention may be beneficial in low-income patients with HF, the investigators said.

HART was funded by the National Institutes of Health. An associate of Dr. Powell reported receiving research funding from Novartis after HART was concluded.

An intervention to teach patients self-management of their chronic heart failure failed to reduce mortality or hospitalizations for the disorder, compared with patient education alone, according to a report in the Sept. 22/29 issue of JAMA.

Nonadherence to heart failure medications ranges from 30% to 60%, and nonadherence to lifestyle recommendations ranges from 50% to 80% in the general population. Previous assessments of self-management techniques to improve adherence have been limited by their small sample sizes, short durations, and inadequate follow-up time, said Lynda H. Powell, Ph.D., of the department of preventive medicine at Rush University Medical Center, Chicago, and her associates.

The investigators designed HART (Heart Failure Adherence and Retention Trial) to have the size, duration, methodologic rigor, and representation of typical HF patients so that it would provide more conclusive results. They assessed mortality and HF hospitalizations after 1 year of self-management counseling and another 1-2 years of follow-up in 902 patients with mild to moderate HF who were recruited at 10 hospitals throughout Chicago.

In all, 451 patients (average age, 64 years) were randomly assigned to receive the study intervention, and the other 451 served as a control group.

Slightly fewer than half of the study subjects were women, and 40% were members of racial/ethnic minority groups. Overall, 23% had preserved systolic function and the remainder had impaired systolic function, making the sample “representative of typical clinical populations.”

At baseline, patients were taking an average of seven medications. Nearly 40% did not adhere to the prescribed dosage of either an ACE inhibitor or a beta-blocker. Median sodium intake was almost twice as high as is recommended for HF patients, and depressive symptoms were evident in nearly 40%.

The study intervention included 18 2-hour group meetings over the course of a year. Patients were educated about medication adherence, sudden weight gain, sodium restriction, moderate physical activity, and stress management, and were given American Heart Association tip sheets concerning HF. The program also included counseling “to help patients develop mastery in problem-solving skills” as well as in five self-management skills: self-monitoring, environmental restructuring, elicitation of support from family and friends, cognitive restructuring, and the relaxation response.

The control group received the AHA tip sheets by mail, and discussed the material by phone with study counselors.

The intervention did not improve the primary end point, which was hospitalization for HF events or death. There were 163 events in the intervention group (40%) and 171 in the control group (41%), a nonsignificant difference. The annual event rate was 18% in the intervention group and 19% in the control group, also a nonsignificant difference.

Patients in both study groups had a mean of 0.7 HF hospitalizations. At the conclusion of the study, there were no differences between the two groups in 6-minute walk times, change in New York Heart Association class, heart rate, respiratory rate, blood pressure, or body mass index. There also were no differences in several measures of quality of life.

Moreover, nonadherence to prescribed ACE inhibitor or beta-blocker therapy had risen by 7% in both groups, Dr. Powell and her colleagues said (JAMA 2010;304:1331-8).

The researchers also performed a post hoc analysis of outcomes in nine subgroups of patients, categorizing patients by age, ethnicity, NYHA class, presence or absence of depressive symptoms, education level, annual income, and presence or absence of three or more comorbid conditions. Only one of these variables – a low annual income – correlated with improved outcomes in subjects who participated in the self-management intervention, compared with control subjects. This suggests that the intervention may be beneficial in low-income patients with HF, the investigators said.

HART was funded by the National Institutes of Health. An associate of Dr. Powell reported receiving research funding from Novartis after HART was concluded.

An intervention to teach patients self-management of their chronic heart failure failed to reduce mortality or hospitalizations for the disorder, compared with patient education alone, according to a report in the Sept. 22/29 issue of JAMA.

Nonadherence to heart failure medications ranges from 30% to 60%, and nonadherence to lifestyle recommendations ranges from 50% to 80% in the general population. Previous assessments of self-management techniques to improve adherence have been limited by their small sample sizes, short durations, and inadequate follow-up time, said Lynda H. Powell, Ph.D., of the department of preventive medicine at Rush University Medical Center, Chicago, and her associates.

The investigators designed HART (Heart Failure Adherence and Retention Trial) to have the size, duration, methodologic rigor, and representation of typical HF patients so that it would provide more conclusive results. They assessed mortality and HF hospitalizations after 1 year of self-management counseling and another 1-2 years of follow-up in 902 patients with mild to moderate HF who were recruited at 10 hospitals throughout Chicago.

In all, 451 patients (average age, 64 years) were randomly assigned to receive the study intervention, and the other 451 served as a control group.

Slightly fewer than half of the study subjects were women, and 40% were members of racial/ethnic minority groups. Overall, 23% had preserved systolic function and the remainder had impaired systolic function, making the sample “representative of typical clinical populations.”

At baseline, patients were taking an average of seven medications. Nearly 40% did not adhere to the prescribed dosage of either an ACE inhibitor or a beta-blocker. Median sodium intake was almost twice as high as is recommended for HF patients, and depressive symptoms were evident in nearly 40%.

The study intervention included 18 2-hour group meetings over the course of a year. Patients were educated about medication adherence, sudden weight gain, sodium restriction, moderate physical activity, and stress management, and were given American Heart Association tip sheets concerning HF. The program also included counseling “to help patients develop mastery in problem-solving skills” as well as in five self-management skills: self-monitoring, environmental restructuring, elicitation of support from family and friends, cognitive restructuring, and the relaxation response.

The control group received the AHA tip sheets by mail, and discussed the material by phone with study counselors.

The intervention did not improve the primary end point, which was hospitalization for HF events or death. There were 163 events in the intervention group (40%) and 171 in the control group (41%), a nonsignificant difference. The annual event rate was 18% in the intervention group and 19% in the control group, also a nonsignificant difference.

Patients in both study groups had a mean of 0.7 HF hospitalizations. At the conclusion of the study, there were no differences between the two groups in 6-minute walk times, change in New York Heart Association class, heart rate, respiratory rate, blood pressure, or body mass index. There also were no differences in several measures of quality of life.

Moreover, nonadherence to prescribed ACE inhibitor or beta-blocker therapy had risen by 7% in both groups, Dr. Powell and her colleagues said (JAMA 2010;304:1331-8).

The researchers also performed a post hoc analysis of outcomes in nine subgroups of patients, categorizing patients by age, ethnicity, NYHA class, presence or absence of depressive symptoms, education level, annual income, and presence or absence of three or more comorbid conditions. Only one of these variables – a low annual income – correlated with improved outcomes in subjects who participated in the self-management intervention, compared with control subjects. This suggests that the intervention may be beneficial in low-income patients with HF, the investigators said.

HART was funded by the National Institutes of Health. An associate of Dr. Powell reported receiving research funding from Novartis after HART was concluded.

An intervention to teach patients self-management of their chronic heart failure failed to reduce mortality or hospitalizations for the disorder, compared with patient education alone, according to a report in the Sept. 22/29 issue of JAMA.

Nonadherence to heart failure medications ranges from 30% to 60%, and nonadherence to lifestyle recommendations ranges from 50% to 80% in the general population. Previous assessments of self-management techniques to improve adherence have been limited by their small sample sizes, short durations, and inadequate follow-up time, said Lynda H. Powell, Ph.D., of the department of preventive medicine at Rush University Medical Center, Chicago, and her associates.

The investigators designed HART (Heart Failure Adherence and Retention Trial) to have the size, duration, methodologic rigor, and representation of typical HF patients so that it would provide more conclusive results. They assessed mortality and HF hospitalizations after 1 year of self-management counseling and another 1-2 years of follow-up in 902 patients with mild to moderate HF who were recruited at 10 hospitals throughout Chicago.

In all, 451 patients (average age, 64 years) were randomly assigned to receive the study intervention, and the other 451 served as a control group.

Slightly fewer than half of the study subjects were women, and 40% were members of racial/ethnic minority groups. Overall, 23% had preserved systolic function and the remainder had impaired systolic function, making the sample “representative of typical clinical populations.”

At baseline, patients were taking an average of seven medications. Nearly 40% did not adhere to the prescribed dosage of either an ACE inhibitor or a beta-blocker. Median sodium intake was almost twice as high as is recommended for HF patients, and depressive symptoms were evident in nearly 40%.

The study intervention included 18 2-hour group meetings over the course of a year. Patients were educated about medication adherence, sudden weight gain, sodium restriction, moderate physical activity, and stress management, and were given American Heart Association tip sheets concerning HF. The program also included counseling “to help patients develop mastery in problem-solving skills” as well as in five self-management skills: self-monitoring, environmental restructuring, elicitation of support from family and friends, cognitive restructuring, and the relaxation response.

The control group received the AHA tip sheets by mail, and discussed the material by phone with study counselors.

The intervention did not improve the primary end point, which was hospitalization for HF events or death. There were 163 events in the intervention group (40%) and 171 in the control group (41%), a nonsignificant difference. The annual event rate was 18% in the intervention group and 19% in the control group, also a nonsignificant difference.

Patients in both study groups had a mean of 0.7 HF hospitalizations. At the conclusion of the study, there were no differences between the two groups in 6-minute walk times, change in New York Heart Association class, heart rate, respiratory rate, blood pressure, or body mass index. There also were no differences in several measures of quality of life.

Moreover, nonadherence to prescribed ACE inhibitor or beta-blocker therapy had risen by 7% in both groups, Dr. Powell and her colleagues said (JAMA 2010;304:1331-8).

The researchers also performed a post hoc analysis of outcomes in nine subgroups of patients, categorizing patients by age, ethnicity, NYHA class, presence or absence of depressive symptoms, education level, annual income, and presence or absence of three or more comorbid conditions. Only one of these variables – a low annual income – correlated with improved outcomes in subjects who participated in the self-management intervention, compared with control subjects. This suggests that the intervention may be beneficial in low-income patients with HF, the investigators said.

HART was funded by the National Institutes of Health. An associate of Dr. Powell reported receiving research funding from Novartis after HART was concluded.

Delaying surgery in adults with acute appendicitis does not appear to adversely affect 30-day outcomes, a study published in the September issue of the Archives of Surgery has shown.

“Because of potentially limited physical and professional staffing, an acute care surgeon may need to delay the operation of less critically ill patients to appropriately care for those requiring immediate attention. Our research demonstrates that the frequent, though previously minimally researched, practice of nonimmediate operative treatment of adult patients with acute appendicitis does not appear to significantly affect patient outcomes,” said Dr. Angela M. Ingraham of the University of Cincinnati and her associates.

They used data from the American College of Surgeons National Surgical Quality Improvement Program to examine 30-day morbidity and mortality outcomes in 32,782 patients treated for acute appendicitis between 2005 and 2009. In 75% of these cases, surgery was begun within 6 hours of admission. However, in 15% surgery was delayed for 6-12 hours, and in 10% it was delayed for more than 12 hours.

The patients, aged 16 and older, had either simple appendicitis (83%) or complicated appendicitis (17%). Seventy-six percent of the operations were laparoscopic and 24% were open.

Delaying the start of surgery, even for more than 12 hours, “[did] not represent a clinically significant burden,” wrote the investigators. After the data were adjusted to account for baseline differences in disease severity, there were no significant differences in overall morbidity or in serious morbidity/mortality across the three time intervals, said Dr. Ingraham, who is also in the division of research and optimal patient care, American College of Surgeons, and her colleagues.

Overall morbidity was 5.6% when appendectomy was performed within 6 hours, 5.6% when it was performed at 6-12 hours, and 6.0% when it was performed 12 hours or more after admission – differences that are not clinically significant. The corresponding rates of the composite outcome of serious morbidity and mortality were 3.0%, 3.1%, and 3.5%, respectively. These differences also are not clinically significant.

The overall length of stay (from surgical admission to discharge) was statistically significantly different among the three groups (1.8 days, 2.0 days, and 3.1 days, respectively), as was the length of postoperative stay (2.2 days for those whose surgery was performed 12 hours or more after admission vs. 1.8 days for the remaining two groups), although the latter was not clinically significant, according to the investigators.

Recent advances in imaging technology and antibiotic therapy have permitted better preoperative assessment and treatment, “allowing for nonoperative management of abscesses and phlegmons, and potentially limiting the need for immediate operative intervention to halt disease progression,” the investigators noted (Arch. Surg. 2010;145:886-92).

They acknowledged some limitations to the study, including the fact that “parity may have been influenced by differences in patient or organizational factors or by clinical interventions” unknown to the authors, but they added that their findings agree with those of “several other studies in the adult and pediatric literature that have found no increased rates of complications among patients who had a delay to appendectomy.”

Dr. Ingraham’s study received no industry support. The study investigators reported no financial disclosures.

Delaying surgery in adults with acute appendicitis does not appear to adversely affect 30-day outcomes, a study published in the September issue of the Archives of Surgery has shown.

“Because of potentially limited physical and professional staffing, an acute care surgeon may need to delay the operation of less critically ill patients to appropriately care for those requiring immediate attention. Our research demonstrates that the frequent, though previously minimally researched, practice of nonimmediate operative treatment of adult patients with acute appendicitis does not appear to significantly affect patient outcomes,” said Dr. Angela M. Ingraham of the University of Cincinnati and her associates.

They used data from the American College of Surgeons National Surgical Quality Improvement Program to examine 30-day morbidity and mortality outcomes in 32,782 patients treated for acute appendicitis between 2005 and 2009. In 75% of these cases, surgery was begun within 6 hours of admission. However, in 15% surgery was delayed for 6-12 hours, and in 10% it was delayed for more than 12 hours.

The patients, aged 16 and older, had either simple appendicitis (83%) or complicated appendicitis (17%). Seventy-six percent of the operations were laparoscopic and 24% were open.

Delaying the start of surgery, even for more than 12 hours, “[did] not represent a clinically significant burden,” wrote the investigators. After the data were adjusted to account for baseline differences in disease severity, there were no significant differences in overall morbidity or in serious morbidity/mortality across the three time intervals, said Dr. Ingraham, who is also in the division of research and optimal patient care, American College of Surgeons, and her colleagues.

Overall morbidity was 5.6% when appendectomy was performed within 6 hours, 5.6% when it was performed at 6-12 hours, and 6.0% when it was performed 12 hours or more after admission – differences that are not clinically significant. The corresponding rates of the composite outcome of serious morbidity and mortality were 3.0%, 3.1%, and 3.5%, respectively. These differences also are not clinically significant.

The overall length of stay (from surgical admission to discharge) was statistically significantly different among the three groups (1.8 days, 2.0 days, and 3.1 days, respectively), as was the length of postoperative stay (2.2 days for those whose surgery was performed 12 hours or more after admission vs. 1.8 days for the remaining two groups), although the latter was not clinically significant, according to the investigators.

Recent advances in imaging technology and antibiotic therapy have permitted better preoperative assessment and treatment, “allowing for nonoperative management of abscesses and phlegmons, and potentially limiting the need for immediate operative intervention to halt disease progression,” the investigators noted (Arch. Surg. 2010;145:886-92).

They acknowledged some limitations to the study, including the fact that “parity may have been influenced by differences in patient or organizational factors or by clinical interventions” unknown to the authors, but they added that their findings agree with those of “several other studies in the adult and pediatric literature that have found no increased rates of complications among patients who had a delay to appendectomy.”

Dr. Ingraham’s study received no industry support. The study investigators reported no financial disclosures.

Delaying surgery in adults with acute appendicitis does not appear to adversely affect 30-day outcomes, a study published in the September issue of the Archives of Surgery has shown.

“Because of potentially limited physical and professional staffing, an acute care surgeon may need to delay the operation of less critically ill patients to appropriately care for those requiring immediate attention. Our research demonstrates that the frequent, though previously minimally researched, practice of nonimmediate operative treatment of adult patients with acute appendicitis does not appear to significantly affect patient outcomes,” said Dr. Angela M. Ingraham of the University of Cincinnati and her associates.

They used data from the American College of Surgeons National Surgical Quality Improvement Program to examine 30-day morbidity and mortality outcomes in 32,782 patients treated for acute appendicitis between 2005 and 2009. In 75% of these cases, surgery was begun within 6 hours of admission. However, in 15% surgery was delayed for 6-12 hours, and in 10% it was delayed for more than 12 hours.

The patients, aged 16 and older, had either simple appendicitis (83%) or complicated appendicitis (17%). Seventy-six percent of the operations were laparoscopic and 24% were open.

Delaying the start of surgery, even for more than 12 hours, “[did] not represent a clinically significant burden,” wrote the investigators. After the data were adjusted to account for baseline differences in disease severity, there were no significant differences in overall morbidity or in serious morbidity/mortality across the three time intervals, said Dr. Ingraham, who is also in the division of research and optimal patient care, American College of Surgeons, and her colleagues.

Overall morbidity was 5.6% when appendectomy was performed within 6 hours, 5.6% when it was performed at 6-12 hours, and 6.0% when it was performed 12 hours or more after admission – differences that are not clinically significant. The corresponding rates of the composite outcome of serious morbidity and mortality were 3.0%, 3.1%, and 3.5%, respectively. These differences also are not clinically significant.

The overall length of stay (from surgical admission to discharge) was statistically significantly different among the three groups (1.8 days, 2.0 days, and 3.1 days, respectively), as was the length of postoperative stay (2.2 days for those whose surgery was performed 12 hours or more after admission vs. 1.8 days for the remaining two groups), although the latter was not clinically significant, according to the investigators.

Recent advances in imaging technology and antibiotic therapy have permitted better preoperative assessment and treatment, “allowing for nonoperative management of abscesses and phlegmons, and potentially limiting the need for immediate operative intervention to halt disease progression,” the investigators noted (Arch. Surg. 2010;145:886-92).

They acknowledged some limitations to the study, including the fact that “parity may have been influenced by differences in patient or organizational factors or by clinical interventions” unknown to the authors, but they added that their findings agree with those of “several other studies in the adult and pediatric literature that have found no increased rates of complications among patients who had a delay to appendectomy.”

Dr. Ingraham’s study received no industry support. The study investigators reported no financial disclosures.