Music-based program may boost seniors’ brain function, mood

By C. E. Huggins

NEW YORK Fri Nov 29, 2013 4:53pm EST

NEW YORK (Reuters Health) – A music-based training program that challenges both the body and the mind may improve brain function and mood among seniors, suggests a new study from Switzerland.

“The take-home message is that 6-months of music-based multitask training (i.e., Jaques-Dalcroze eurhythmics) – a specific training regimen which was previously shown to be effective in improving gait and reducing falls – has beneficial effects on cognition and mood in older adults,” Dr. Mélany Hars, of Geneva University Hospitals, told Reuters Health in an email.

Jacques-Dalcroze eurhythmics was developed in the early part of the 20th century by the Swiss composer Emile Jaques-Dalcroze as a way to better understand music through movement. It is practiced worldwide, particularly in the fields of music, theater, dance and therapy, according to Hars.

A typical Jacques-Dalcroze session involves participants adapting their movements to the rhythmic changes of improvised piano music. In Hars’ study, the participants were challenged to perform specific multitasking skills, such as walking to the rhythm of a piano while handling a percussion instrument and responding to changes in the piano’s rhythm.

The study participants were also asked to perform quick reaction exercises, such as starting or stopping to walk or changing their walking speed on command, as well as matching their steps to the long or short music notes that were played.

The study included 134 men and women aged 75 years, on average, who were all at increased risk for falls but who did not live in a nursing home or other facility. These seniors were randomly divided into a study group that attended hour-long music-based multitasking sessions once a week for 25 weeks or a comparison group that just kept up their normal lifestyles and did not attend training sessions.

At the beginning of the study, both groups underwent a battery of tests for mental function and mood.

After six months, the 66 adults who participated in the music training sessions showed improved cognitive function, particularly on a test of their degree of sensitivity to interference, and decreased anxiety, compared to the group that had not done the training.

“This may have implications for everyday life function,” since many situations require individuals to pay selective attention to one thing while blocking out something else, such as distracting surroundings, Hars and her coauthors write in the journal Age and Ageing.

How the training might be responsible for the improvements is unknown, Hars acknowledges.

However, she noted, “some studies suggest that music can mitigate effects of the aging brain… (and) some studies have revealed that specific physical exercise regimens may enhance (not only) cognitive performance but also brain function or brain structure of older adults.”

Jacques-Dalcroze eurhythmics puts it all together in a program that combines gait, balance, movement coordination and flexibility training while also engaging attention and memory skills, Hars said.

This “is likely to engage multiple brain regions through a combination of music, rhythm, and exercise,” Hars said.

Whether the training is also linked with fewer falls or improved walking ability in these seniors remains to be studied, the researchers point out in their report.

Source: bit.ly/1jSfqxt Age and Ageing, online November 7, 2013.

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Thrombosis Risk with HeartMate II

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Cardiovascular

Published: Nov 29, 2013

By Todd Neale, Senior Staff Writer, MedPage Today
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

Action Points

  • The rate of pump thrombosis associated with the HeartMate II left ventricular assist device (LVAD) increased in the last few years, going higher than rates seen in pre-approval clinical trial, and the reasons are unknown.
  • Note that the events are happening sooner, with the median time from implantation to thrombosis decreasing from 18.6 months before March 2011 to 2.7 months after that date.

The rate of pump thrombosis associated with the HeartMate II left ventricular assist device (LVAD) increased in the last few years, going higher than rates seen in pre-approval clinical trials, a three-center study showed.

Before March 2011, the rate of confirmed pump thrombosis 3 months after implantation was 2.2%, but by January 2013, the rate had risen to 8.4%, according to Randall Starling, MD, MPH, of the Cleveland Clinic, and colleagues.

In addition, the events are happening sooner, with the median time from implantation to thrombosis dropping from 18.6 months before March 2011 to 2.7 months after that date, the researchers reported online in the New England Journal of Medicine.

“We recognize that LVADs provide life-sustaining treatment for many patients with advanced heart failure,” they wrote. “However, recommendations for LVAD therapy should account for this updated risk-benefit profile.”

The reasons behind the increase in pump thrombosis — which was confirmed in an analysis by researchers at the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) after the FDA was made aware of the issue — remain unclear, Starling told MedPage Today. He noted that he and his colleagues have had discussions with representatives from Thoratec, which makes HeartMate II.

“To our knowledge, they have looked carefully but haven’t pinpointed anything specific,” Starling said. “So we just don’t know [the reason] at this point.”

In an emailed statement, Thoratec said “there are a number of factors that could contribute to thrombosis, including underlying patient condition, ongoing patient and device management practices, pump implantation technique, and device-related factors. We have performed extensive analysis on HeartMate II and have not identified any change that would cause the increase observed in the INTERMACS registry.”

The company pointed out that the INTERMACS analysis showed a consistently high 6-month survival rate (86%) since the device has been on the market, and that the rate is higher than seen in the clinical trials (75%).

After approval, the HeartMate II device became an important treatment option for patients with advanced heart failure — both as a bridge to transplant and as destination therapy. In clinical trials and postmarketing studies, the rate of pump thrombosis associated with its use was 2% to 4%.

However, a clinical quality review at the Cleveland Clinic demonstrated a sudden increase in pump thrombosis starting around March 2011.

In the current study, Starling and colleagues pooled data from the Cleveland Clinic and two other centers — Washington University Barnes-Jewish Hospital, and Duke University Medical Center — to see whether the phenomenon was real. The analysis included 837 patients (mean age 55) who had a total of 895 devices implanted from January 2004 through May 2013.

Overall, 66 patients had 72 confirmed cases of pump thrombosis, defined as “a thrombus found on the blood-contacting surfaces of the HeartMate II, its inflow cannula, or its outflow conduit at pump replacement, urgent transplantation, or autopsy.”

The rise in the rate of confirmed pump thrombosis initially seen at the Cleveland Clinic was consistent across all three centers and multiple surgeons.

The increase was accompanied by a similar rise in elevated levels of lactate dehydrogenase (LDH), which serves as an indicator of hemolysis caused by thrombus formation in the pump. LDH levels went up from an average of 540 IU per liter to 1,490 IU per liter in the 6 weeks leading up to a confirmed case of pump thrombosis.

Various strategies were used to manage pump thrombosis: urgent heart transplantation in 11 cases, pump replacement in 21 cases, pump removal in two cases, and medical management in 38 cases.

Patients who had a transplant or a pump replacement for thrombosis had a 6-month mortality rate similar to that seen in patients who didn’t have pump thrombosis. However, nearly half of patients who did not undergo transplantation or have their pump replaced (48.2%) died within 6 months.

“We know that this is a potentially very serious, life-threatening complication and when applicable we tend to move quickly to pump replacement or transplantation if that’s applicable to the patient,” Starling said.

He said the issue of increasing pump thrombosis has changed how patients with the devices are currently managed.

LDH levels are measured consistently to watch for increases that suggest pump thrombosis, and anticoagulation is performed more carefully, he said.

“I think that we and other centers in general relaxed … to some degree our anticoagulation based on some reports that appeared in the literature,” Starling said. “And we’ve gone back to following the manufacturer’s recommendations completely: running the INRs between 2 and 3, using baby aspirin, [and] starting heparin 24 hours postop and not letting the patient come off heparin until the INR is therapeutic.”

In addition, a new echocardiographic evaluation called a ramp test is commonly used to check for pump thrombosis in suspected cases.

Starling reported relationships with Thoratec — which makes the HeartMate II device — and HeartWare. His co-authors reported relationships with Thoratec, HeartWare, Abiomed, and Syncardia.


Primary source: New England Journal of Medicine
Source reference: Starling R, et al “Unexpected abrupt increase in left ventricular assist device thrombosis” N Engl J Med 2013; DOI: 10.1056/NEJMoa1313385.

Todd Neale, MedPage Today Staff Writer, got his start in journalism at Audubon Magazine and made a stop in directory publishing before landing at MedPage Today. He received a B.S. in biology from the University of Massachusetts Amherst and an M.A. in journalism from the Science, Health, and Environmental Reporting program at New York University.

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Risk factors may point to less-safe senior drivers

By Allison Bond

NEW YORK Fri Nov 29, 2013 4:09pm EST

NEW YORK (Reuters) – Tests of physical abilities, such as balance and strength, may reveal how well an elderly driver will perform on the road, according to a new study.

Trouble with balance, weak lower limbs and poor neck flexibility were among the attributes Australian researchers linked to a higher risk of less-safe driving in The Journals of Gerontology: Series A.

“Although there has been a lot of research on the cognitive and visual predictors of driving performance and safety, very little work has so far looked at physical function and its relation to driving,” said Philippe Lacherez, a post-doctoral fellow at Queensland University of Technology who led the study.

Lacherez and his colleagues gave 270 people between the ages of 70 and 88 a battery of physical tests to gauge their strength, flexibility, balance, reaction times and sensory perception. Next, the participants’ driving performance was evaluated for safety.

About 17 percent of the participants made critical errors while driving in a test that was scored by a professional driving instructor and involved a range of traffic densities and complex or simple intersections.

In the physical abilities tests, the unsafe drivers tended to have a decreased ability to move the neck, slower reaction times, poor perception of vibration and lack of strength in the legs and feet. Factors that were not linked with driving safety included the ability to sense where the body or limbs are in space.

The results are preliminary but may open a new avenue to ways of ensuring that older drivers are safe to be on the road, researchers said.

“The study addresses an issue that is a big concern,” said Sharon Brangman, chief of geriatrics at Upstate Medical University in Syracuse, New York. She was not involved in the study.

“We have so many (older) patients who are driving, and we don’t have objective ways to determine who should stay on the road,” Brangman said.

Some U.S. states, such as New Jersey, already have review programs in place that evaluate older adults and determine whether they should continue to drive. However, there is no standardized, nationwide approach used to evaluate driving safety.

“It would be good to have an objective way for physicians or others to quantify whether someone really is safe behind the wheel,” said Brangman, who also noted the need for a change in national policy to better screen and guide older drivers.

As always, older patients and their families should talk to their doctors if they feel they or a loved one may be an unsafe driver. This study can serve as a way to initiate that discussion, Brangman told Reuters Health.

“It’s a good way to start the conversation,” she said. And in the future, results of studies such as this one “may provide some hard evidence that can be given to the patient or family that could justify stopping driving.”

SOURCE: bit.ly/1jvEk5R bit.ly/1jvEk5R Journals of Gerontology: Series A, online October 29, 2013.

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Staying active all day linked to healthy aging

By Kathryn Doyle

NEW YORK Fri Nov 29, 2013 2:52pm EST

Two joggers run along the embankment of Aare river during the first snowfall in Bern November 21, 2013. REUTERS/Ruben Sprich

Two joggers run along the embankment of Aare river during the first snowfall in Bern November 21, 2013.

Credit: Reuters/Ruben Sprich

NEW YORK (Reuters Health) – A generally active life, even without regular exercise sessions, was tied to better heart health and greater longevity in a study of older Swedes.

Based on nearly 3,900 men and women over age 60 in Stockholm, the study adds to evidence suggesting that just sitting around may be actively harmful, researchers say.

“We have known for 60 years that physical activity is important for the heart,” said lead author Elin Ekblom-Bak, of the Ã…strand Laboratory of Work Physiology of the Swedish School of Sport and Health Sciences in Stockholm.

But until recently the research has mainly focused on exercise and has “forgotten” about the background activity that we do during daily life, she told Reuters Health.

Whether someone exercises vigorously or not, it still usually only takes up a small fraction of the day. That leaves the rest of the time for either sitting still or engaging in non-exercise activities, like home repairs, lawn care and gardening, car maintenance, hunting or fishing.

For older people, who tend to exercise vigorously less than younger people, spending more time doing low-intensity activities like these could help cut down on sitting time, Ekblom-Bak and her colleagues write in the British Journal of Sports Medicine.

Between 1997 and 1999, more than 5,000 60-year-olds were invited to participate in the study, which began with a questionnaire about health history, lifestyle and daily activities, as well as medical tests and measurements.

At the study’s outset, people who were more active on a daily basis, regardless of their exercise levels, tended to have smaller waists and healthier cholesterol levels.

The participants were followed for the next 12.5 years. During that time nearly 500 people had a first-time heart attack or stroke, and nearly 400 people died from any cause.

People who had reported high levels of daily non-exercise activity were less likely to suffer a heart-related event and less likely to die than those who were the least active.

For every 100 people reporting low activity levels who had a heart attack or stroke, for example, only 73 highly active people experienced such events. For every 100 of the least active who died, only 70 of the most active did.

“These are fascinating findings,” said David Dunstan, of the Baker IDI Heart & Diabetes Institute in Melbourne, Australia, “but not really surprising since other studies that have looked at this from a different angle – that is, describing the detrimental relationship between excessive sitting and mortality outcomes – are essentially showing the same thing but in reverse because there is such a high correlation between sitting time and nonexercise physical activity behaviors.”

While sitting, muscles do not contract and blood flow decreases, which reduces the efficiency of many body processes, like absorbing glucose from the blood, said Dunstan, who studies heart health and exercise.

Non-exercise activity likely prevents the general slowing-down associated with sitting, he told Reuters Health.

“In addition to engaging in regular health enhancing exercise, people should be encouraged to also think what they do during the long periods in the day in which they are not exercising,” he said in an email.

“Engaging in regular exercise is still important,” Ekblom-Bak said. “We saw that those who exercised regularly and that also had a daily physically active life had the lowest risk profile of all.”

Moderate-to-vigorous exercise helps strengthen the heart muscle and other body muscles, and may help regulate blood pressure more than general activity, Dunstan said.

But it is important for doctors and society in general to promote daily activity, not just exercise, she said.

“Human beings are designed to move,” said Phillip B. Sparling, a professor of Applied Physiology and Health Behavior at the Georgia Institute of Technology in Atlanta who was not involved with the new study.

“Ideally, we should have a mix of all levels of activity,” he said. “But, regardless of whether one exercises or not, the new message is to move more and sit less throughout the day.”

SOURCE: bit.ly/1gmmyCe British Journal of Sports Medicine, online October 28, 2013.

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Military deployments tied to teens' depression

By Kathleen Raven

NEW YORK Fri Nov 29, 2013 1:28pm EST

NEW YORK (Reuters Health) – Adolescents who experience the deployment of a family member in the U.S. military may face an increased risk of depression, suggests a new study.

Ninth- and eleventh-grade students in California public schools with two or more deployment experiences over the past decade were 56 percent more likely to feel sad or hopeless compared with their non-military-family peers, the researchers found.

The same kids were 34 percent more likely to have suicidal thoughts.

The study is one of very few that compare students from military families to their non-military peers, said Julie Cederbaum, an assistant professor of social work at the University of Southern California in Los Angeles, who led the study.

“One of the goals of our research was to highlight kids’ experiences, which have been unintentionally ignored in the past,” Cederbaum told Reuters Health.

Past research in this area has mostly been conducted in clinical settings or at summer camps designed specifically for military families, Cederbaum and her colleagues write in the Journal of Adolescent Health.

Less than one percent of the U.S. population has been on active duty at any point in time since the attacks of September 11, 2001, according to the Pew Research Center in Washington, D.C.

Kids in military families may feel isolated with so few peers who can share and understand their experiences, Cederbaum’s team points out in their report.

For their study, the researchers tacked on an extra questionnaire to a statewide survey administered every two years to public schools in California. The researchers chose to give the military questionnaire to eight public school districts in the southern part of the state. Nearly half of all respondents were Hispanic, followed by white, mixed race, Asian and black, and students could complete the paper-and-pencil survey in English or Spanish.

Of the 14,300 students surveyed, less than 14 percent reported having a connection with the military.

For their deployment analysis, the researchers narrowed their focus to the ninth and eleventh grades only, which included about 9,300 students from both military and non-military families.

The researchers found that kids with a family member in the military had higher rates of depression, hopelessness and suicidal thoughts than non-military peers.

When they adjusted for a variety of factors, it turned out that the differences seemed to be largely driven by the number of deployments kids experienced.

Comparing just the teens with military connections, they found those with one deployment in the family were 15 percent more likely to feel depressed than kids with no deployment experiences, and those with two or more deployments were 41 percent more likely to report symptoms of depression..

“There is the stress of being concerned and worried about the parent or sibling who has been deployed,” Cederbaum said. “While contact has improved drastically, you don’t always know how well they are doing.”

Comparing the overall results to recent statistics for U.S. teens in general, Cederbaum’s team writes that 28.5 percent of teens report feeling sad or hopeless, for example, while 33.7 percent of kids with a parent in the military and 35.3 percent with a sibling in the military reported sadness or hopelessness in the new study.

They also found that 24.8 percent of kids with a parent in the military and 26.1 percent with a sibling in the military reported having had suicidal thoughts. That compares to a rate of about 15 percent in the general population of teens.

“This study collected data a little further away from the height of the wars,” Commander Dr. Gregory Gorman said. “It shows us that these are persistent symptoms.”

Gorman is a Navy pediatrician at the Walter Reed National Military Medical Center and teaches at the Uniformed Services University of the Health Sciences in Bethesda, Maryland. He was not involved with the new study.

Pediatricians and family doctors need to be aware of the risks this population faces because up to two-thirds of contact with children in military families is done in civilian doctor’s offices, Gorman said.

He suggested that non-military doctors, especially in states like California with a large military presence, can simply ask young patients if they live in a military family. “Just asking simple questions leads to more questions and answers,” Gorman explained.

“Schools are taking these findings very seriously,” Cederbaum said.

Before the researchers approached school officials in order to collect data specific to military connectivity, few districts had numbers on how many students lived in military families, she added.

Cederbaum said there are things that parents and school officials can do. For example, school officials in one southern California district celebrated a school-wide event when a student’s parent returned home. Other schools have conducted service events, like collecting food for troops.

“Part of the experience of depression can be isolation. Kids need to be able to connect with one another and know that others feel the way they do,” Cederbaum said.

The researchers acknowledge several weaknesses with their current study, for example, the kids’ self-reports of depression and suicidal thoughts were not cross-checked against another source such as physician records. Also, the study gathered data from a single point in time, rather than follow the subjects for a period to detect mental health fluctuations.

Gorman stressed an important finding from the study is that only deployments appear connected with increased sadness, suicidal thoughts and depression, not the circumstance of merely living in a military family.

“This speaks to the resilience of military families. They are a very unique culture in America,” he said.

SOURCE: bit.ly/1auD9lT Journal of Adolescent Health, online November 18, 2013.

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Military deployments tied to teens’ depression

By Kathleen Raven

NEW YORK Fri Nov 29, 2013 1:28pm EST

NEW YORK (Reuters Health) – Adolescents who experience the deployment of a family member in the U.S. military may face an increased risk of depression, suggests a new study.

Ninth- and eleventh-grade students in California public schools with two or more deployment experiences over the past decade were 56 percent more likely to feel sad or hopeless compared with their non-military-family peers, the researchers found.

The same kids were 34 percent more likely to have suicidal thoughts.

The study is one of very few that compare students from military families to their non-military peers, said Julie Cederbaum, an assistant professor of social work at the University of Southern California in Los Angeles, who led the study.

“One of the goals of our research was to highlight kids’ experiences, which have been unintentionally ignored in the past,” Cederbaum told Reuters Health.

Past research in this area has mostly been conducted in clinical settings or at summer camps designed specifically for military families, Cederbaum and her colleagues write in the Journal of Adolescent Health.

Less than one percent of the U.S. population has been on active duty at any point in time since the attacks of September 11, 2001, according to the Pew Research Center in Washington, D.C.

Kids in military families may feel isolated with so few peers who can share and understand their experiences, Cederbaum’s team points out in their report.

For their study, the researchers tacked on an extra questionnaire to a statewide survey administered every two years to public schools in California. The researchers chose to give the military questionnaire to eight public school districts in the southern part of the state. Nearly half of all respondents were Hispanic, followed by white, mixed race, Asian and black, and students could complete the paper-and-pencil survey in English or Spanish.

Of the 14,300 students surveyed, less than 14 percent reported having a connection with the military.

For their deployment analysis, the researchers narrowed their focus to the ninth and eleventh grades only, which included about 9,300 students from both military and non-military families.

The researchers found that kids with a family member in the military had higher rates of depression, hopelessness and suicidal thoughts than non-military peers.

When they adjusted for a variety of factors, it turned out that the differences seemed to be largely driven by the number of deployments kids experienced.

Comparing just the teens with military connections, they found those with one deployment in the family were 15 percent more likely to feel depressed than kids with no deployment experiences, and those with two or more deployments were 41 percent more likely to report symptoms of depression..

“There is the stress of being concerned and worried about the parent or sibling who has been deployed,” Cederbaum said. “While contact has improved drastically, you don’t always know how well they are doing.”

Comparing the overall results to recent statistics for U.S. teens in general, Cederbaum’s team writes that 28.5 percent of teens report feeling sad or hopeless, for example, while 33.7 percent of kids with a parent in the military and 35.3 percent with a sibling in the military reported sadness or hopelessness in the new study.

They also found that 24.8 percent of kids with a parent in the military and 26.1 percent with a sibling in the military reported having had suicidal thoughts. That compares to a rate of about 15 percent in the general population of teens.

“This study collected data a little further away from the height of the wars,” Commander Dr. Gregory Gorman said. “It shows us that these are persistent symptoms.”

Gorman is a Navy pediatrician at the Walter Reed National Military Medical Center and teaches at the Uniformed Services University of the Health Sciences in Bethesda, Maryland. He was not involved with the new study.

Pediatricians and family doctors need to be aware of the risks this population faces because up to two-thirds of contact with children in military families is done in civilian doctor’s offices, Gorman said.

He suggested that non-military doctors, especially in states like California with a large military presence, can simply ask young patients if they live in a military family. “Just asking simple questions leads to more questions and answers,” Gorman explained.

“Schools are taking these findings very seriously,” Cederbaum said.

Before the researchers approached school officials in order to collect data specific to military connectivity, few districts had numbers on how many students lived in military families, she added.

Cederbaum said there are things that parents and school officials can do. For example, school officials in one southern California district celebrated a school-wide event when a student’s parent returned home. Other schools have conducted service events, like collecting food for troops.

“Part of the experience of depression can be isolation. Kids need to be able to connect with one another and know that others feel the way they do,” Cederbaum said.

The researchers acknowledge several weaknesses with their current study, for example, the kids’ self-reports of depression and suicidal thoughts were not cross-checked against another source such as physician records. Also, the study gathered data from a single point in time, rather than follow the subjects for a period to detect mental health fluctuations.

Gorman stressed an important finding from the study is that only deployments appear connected with increased sadness, suicidal thoughts and depression, not the circumstance of merely living in a military family.

“This speaks to the resilience of military families. They are a very unique culture in America,” he said.

SOURCE: bit.ly/1auD9lT Journal of Adolescent Health, online November 18, 2013.

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Thrombosis With LVAD a Growing Issue

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Cardiovascular

Published: Nov 29, 2013

By Todd Neale, Senior Staff Writer, MedPage Today
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

Action Points

  • The rate of pump thrombosis associated with the HeartMate II left ventricular assist device (LVAD) increased in the last few years, going higher than rates seen in pre-approval clinical trial, and the reasons are unknown.
  • Note that the events are happening sooner, with the median time from implantation to thrombosis decreasing from 18.6 months before March 2011 to 2.7 months after that date.

The rate of pump thrombosis associated with the HeartMate II left ventricular assist device (LVAD) increased in the last few years, going higher than rates seen in pre-approval clinical trials, a three-center study showed.

Before March 2011, the rate of confirmed pump thrombosis 3 months after implantation was 2.2%, but by January 2013, the rate had risen to 8.4%, according to Randall Starling, MD, MPH, of the Cleveland Clinic, and colleagues.

In addition, the events are happening sooner, with the median time from implantation to thrombosis dropping from 18.6 months before March 2011 to 2.7 months after that date, the researchers reported online in the New England Journal of Medicine.

“We recognize that LVADs provide life-sustaining treatment for many patients with advanced heart failure,” they wrote. “However, recommendations for LVAD therapy should account for this updated risk-benefit profile.”

The reasons behind the increase in pump thrombosis — which was confirmed in an analysis by researchers at the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) after the FDA was made aware of the issue — remain unclear, Starling told MedPage Today. He noted that he and his colleagues have had discussions with representatives from Thoratec, which makes HeartMate II.

“To our knowledge, they have looked carefully but haven’t pinpointed anything specific,” Starling said. “So we just don’t know [the reason] at this point.”

In an emailed statement, Thoratec said “there are a number of factors that could contribute to thrombosis, including underlying patient condition, ongoing patient and device management practices, pump implantation technique, and device-related factors. We have performed extensive analysis on HeartMate II and have not identified any change that would cause the increase observed in the INTERMACS registry.”

The company pointed out that the INTERMACS analysis showed a consistently high 6-month survival rate (86%) since the device has been on the market, and that the rate is higher than seen in the clinical trials (75%).

After approval, the HeartMate II device became an important treatment option for patients with advanced heart failure — both as a bridge to transplant and as destination therapy. In clinical trials and postmarketing studies, the rate of pump thrombosis associated with its use was 2% to 4%.

However, a clinical quality review at the Cleveland Clinic demonstrated a sudden increase in pump thrombosis starting around March 2011.

In the current study, Starling and colleagues pooled data from the Cleveland Clinic and two other centers — Washington University Barnes-Jewish Hospital, and Duke University Medical Center — to see whether the phenomenon was real. The analysis included 837 patients (mean age 55) who had a total of 895 devices implanted from January 2004 through May 2013.

Overall, 66 patients had 72 confirmed cases of pump thrombosis, defined as “a thrombus found on the blood-contacting surfaces of the HeartMate II, its inflow cannula, or its outflow conduit at pump replacement, urgent transplantation, or autopsy.”

The rise in the rate of confirmed pump thrombosis initially seen at the Cleveland Clinic was consistent across all three centers and multiple surgeons.

The increase was accompanied by a similar rise in elevated levels of lactate dehydrogenase (LDH), which serves as an indicator of hemolysis caused by thrombus formation in the pump. LDH levels went up from an average of 540 IU per liter to 1,490 IU per liter in the 6 weeks leading up to a confirmed case of pump thrombosis.

Various strategies were used to manage pump thrombosis: urgent heart transplantation in 11 cases, pump replacement in 21 cases, pump removal in two cases, and medical management in 38 cases.

Patients who had a transplant or a pump replacement for thrombosis had a 6-month mortality rate similar to that seen in patients who didn’t have pump thrombosis. However, nearly half of patients who did not undergo transplantation or have their pump replaced (48.2%) died within 6 months.

“We know that this is a potentially very serious, life-threatening complication and when applicable we tend to move quickly to pump replacement or transplantation if that’s applicable to the patient,” Starling said.

He said the issue of increasing pump thrombosis has changed how patients with the devices are currently managed.

LDH levels are measured consistently to watch for increases that suggest pump thrombosis, and anticoagulation is performed more carefully, he said.

“I think that we and other centers in general relaxed … to some degree our anticoagulation based on some reports that appeared in the literature,” Starling said. “And we’ve gone back to following the manufacturer’s recommendations completely: running the INRs between 2 and 3, using baby aspirin, [and] starting heparin 24 hours postop and not letting the patient come off heparin until the INR is therapeutic.”

In addition, a new echocardiographic evaluation called a ramp test is commonly used to check for pump thrombosis in suspected cases.

Starling reported relationships with Thoratec — which makes the HeartMate II device — and HeartWare. His co-authors reported relationships with Thoratec, HeartWare, Abiomed, and Syncardia.


Primary source: New England Journal of Medicine
Source reference: Starling R, et al “Unexpected abrupt increase in left ventricular assist device thrombosis” N Engl J Med 2013; DOI: 10.1056/NEJMoa1313385.

Todd Neale, MedPage Today Staff Writer, got his start in journalism at Audubon Magazine and made a stop in directory publishing before landing at MedPage Today. He received a B.S. in biology from the University of Massachusetts Amherst and an M.A. in journalism from the Science, Health, and Environmental Reporting program at New York University.

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Novo to launch mid-stage tests with new diabetes pill

By Ben Hirschler

LONDON Thu Nov 28, 2013 12:46pm EST

LONDON (Reuters) – Novo Nordisk is about to launch a mid-stage clinical study with a tablet version of a so-called GLP-1 medicine as it steps up the hunt for diabetes pills that can replace injections.

The Phase II trial may start as early as next week and will involve approximately 600 patients, Chief Science Officer Mads Krogsgaard Thomsen said on Thursday.

“It is a milestone because this is not incremental innovation, it’s disruptive innovation,” he told Reuters in an interview during a visit to London.

Results of the study are expected in around a year’s time.

The Danish company is already the world’s biggest supplier of diabetes medicines, which include its popular GLP-1 product Victoza. Like its top-selling insulins, Victoza is currently delivered using a pen injection device.

An oral pill version would mark a step-change in therapy by making treatment far more convenient, opening up a major new market at a time when cases of diabetes are soaring worldwide.

A total of 382 million people are now estimated to be living with the disease. The vast majority have type 2 diabetes, the kind linked to obesity and lack of exercise.

Sales of diabetes drugs were worth $42.4 billion worldwide in 2012, according to healthcare information company IMS Health.

Glucagon-like peptide-1 (GLP-1) drugs work by stimulating the release of insulin when blood sugar levels become too low.

Novo’s Victoza is the market leader, with sales last year of 9.5 billion Danish crowns ($1.7 billion), but it faces increasing competition, including from a potential new rival from Eli Lilly called dulaglutide.

Making an oral form of such drugs is far from simple and a key hurdle is to ensure that the medicine is adequately absorbed in the body.

Thomsen said the technical challenges meant there might be setbacks in the development program but he was increasingly optimistic that producing an effective GLP-1 pill was feasible.

“The data we have so far suggests we can do it,” he said, adding that Novo was well ahead of rivals in the field.

The 600-patient trial will compare the new once-daily GLP-1 pill against a weekly injection of a GLP-1 medicine, known as semaglutide, that Novo currently has in Phase III trials.

If all goes well, Novo believes the GLP-1 pill could hit the market in around five or six years time.

Novo is also working on an oral version of insulin but that is at an earlier stage, with a decision on progressing into Phase II testing still around a year away.

After two decades of outperforming its pharmaceutical industry rivals, shares in Novo have stalled this year following setbacks for a new long-acting insulin and worries over the prices its products can command.

The company will seek to reassure investors about its prospects at a capital markets day on December 3. ($1 = 5.4947 Danish crowns)

(Editing by Pravin Char)

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Acupuncture could help in the dentist's chair

By Kathleen Raven

NEW YORK Thu Nov 28, 2013 12:17pm EST

NEW YORK (Reuters Health) – Acupuncture may provide relief for dental patients who reflexively gag during procedures like teeth impressions, according to Italian researchers.

Up to 20 percent of the U.S. population has severe anxiety at the dentist’s office. People who cannot help their gag reflex may unintentionally deprive themselves of the best dental care, write Giuseppa Bilello and Antonella Fregapane, both from the University of Palermo in Sicily.

Acupuncture may be one strategy to solve that problem, the pair suggests.

“It is a small study, and that is one weakness,” Dr. Palle Rosted told Reuters Health. “But it is a good start.”

Rosted is a consultant acupuncturist with Weston Park Hospital in Sheffield, England. He was not involved with the current study.

The researchers recruited 20 people with a history of gag reflex in the dental chair to have upper and lower teeth impressions taken under normal circumstances and then immediately after acupuncture.

Participants ranged in age from 19 to 80. For the first round of upper teeth impressions, they reported an average gag reflex score of 7 on a 0-10 scale, with 10 representing the maximum nausea sensation.

During the second round, the researchers applied acupuncture needles about 30 seconds before taking impressions and left the needles in until the procedure ended. On average, gag reflex scores dropped to just 1.

The pattern was similar for gag reflex scores during lower teeth impressions done with and without acupuncture, according to findings published in the journal Acupuncture in Medicine.

The researchers point out that they can’t be sure the improvements were due to the acupuncture needles themselves – in part because there was no comparison group that didn’t get acupuncture. Another possibility is that gag reflex scores improved because participants were more used to the impressions the second time around.

Still, “It has certainly given us some more evidence that acupuncture may be effective,” Rosted said.

The study’s positive result “is something that we doctors definitely need exposure to and to keep in mind as a possible option,” Dr. Preeti Nair told Reuters Health. “We rarely think of acupuncture, and usually use local anesthetics.”

Nair was not part of the current research. She has studied gag reflex at the People’s College of Dental Sciences & Research Centre in Bhopal, India.

One difference between a drug like local anesthesia and acupuncture could be side effects.

“We haven’t gotten all of the details in our hand, but with acupuncture, the side effects could be less,” Nair said. Much more research is needed on the subject, she added.

In order for a large, randomized controlled trial – the gold standard in medical research – to be done on this subject, dental offices and academic institutions may have to work together, said Chris Dickinson of King’s College London Dental Institute at Guy’s Hospital in England.

In England, the British Dental Acupuncture Society offers training for dentists in certain dental applications of acupuncture, said Dickinson, who was not involved in the new study.

“There are very few contraindications associated with acupuncture and dental operations that we’ve experienced,” Dickinson told Reuters Health. “But we don’t use the technique in patients with metal allergies, pregnant women and those with needle phobias.”

Dickinson noted that other acupuncture points could have been used for gag control such as ear points and LI4, also known as the Hegu point.

Researchers in the current study placed needles in the PC6, EX 1 and CV24 acupuncture points on the face and wrist.

“The message to dentists is that it’s a simple technique and easily learned,” Dickinson said. “It’s also cost-effective. Even though it does not work in every case there’s very little lost by trying it.”

In the U.S., acupuncture typically costs about $100 per session.

One of the positive aspects of acupuncture is that after an operation, a patient may choose to drive home, which is not possible with other treatments, such as general anesthesia, Rosted said

“The risk of causing harm with this treatment is nearly non-existent,” he said.

SOURCE: bit.ly/1h3eEAt Acupuncture in Medicine, online November 5, 2013.

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Acupuncture could help in the dentist’s chair

By Kathleen Raven

NEW YORK Thu Nov 28, 2013 12:17pm EST

NEW YORK (Reuters Health) – Acupuncture may provide relief for dental patients who reflexively gag during procedures like teeth impressions, according to Italian researchers.

Up to 20 percent of the U.S. population has severe anxiety at the dentist’s office. People who cannot help their gag reflex may unintentionally deprive themselves of the best dental care, write Giuseppa Bilello and Antonella Fregapane, both from the University of Palermo in Sicily.

Acupuncture may be one strategy to solve that problem, the pair suggests.

“It is a small study, and that is one weakness,” Dr. Palle Rosted told Reuters Health. “But it is a good start.”

Rosted is a consultant acupuncturist with Weston Park Hospital in Sheffield, England. He was not involved with the current study.

The researchers recruited 20 people with a history of gag reflex in the dental chair to have upper and lower teeth impressions taken under normal circumstances and then immediately after acupuncture.

Participants ranged in age from 19 to 80. For the first round of upper teeth impressions, they reported an average gag reflex score of 7 on a 0-10 scale, with 10 representing the maximum nausea sensation.

During the second round, the researchers applied acupuncture needles about 30 seconds before taking impressions and left the needles in until the procedure ended. On average, gag reflex scores dropped to just 1.

The pattern was similar for gag reflex scores during lower teeth impressions done with and without acupuncture, according to findings published in the journal Acupuncture in Medicine.

The researchers point out that they can’t be sure the improvements were due to the acupuncture needles themselves – in part because there was no comparison group that didn’t get acupuncture. Another possibility is that gag reflex scores improved because participants were more used to the impressions the second time around.

Still, “It has certainly given us some more evidence that acupuncture may be effective,” Rosted said.

The study’s positive result “is something that we doctors definitely need exposure to and to keep in mind as a possible option,” Dr. Preeti Nair told Reuters Health. “We rarely think of acupuncture, and usually use local anesthetics.”

Nair was not part of the current research. She has studied gag reflex at the People’s College of Dental Sciences & Research Centre in Bhopal, India.

One difference between a drug like local anesthesia and acupuncture could be side effects.

“We haven’t gotten all of the details in our hand, but with acupuncture, the side effects could be less,” Nair said. Much more research is needed on the subject, she added.

In order for a large, randomized controlled trial – the gold standard in medical research – to be done on this subject, dental offices and academic institutions may have to work together, said Chris Dickinson of King’s College London Dental Institute at Guy’s Hospital in England.

In England, the British Dental Acupuncture Society offers training for dentists in certain dental applications of acupuncture, said Dickinson, who was not involved in the new study.

“There are very few contraindications associated with acupuncture and dental operations that we’ve experienced,” Dickinson told Reuters Health. “But we don’t use the technique in patients with metal allergies, pregnant women and those with needle phobias.”

Dickinson noted that other acupuncture points could have been used for gag control such as ear points and LI4, also known as the Hegu point.

Researchers in the current study placed needles in the PC6, EX 1 and CV24 acupuncture points on the face and wrist.

“The message to dentists is that it’s a simple technique and easily learned,” Dickinson said. “It’s also cost-effective. Even though it does not work in every case there’s very little lost by trying it.”

In the U.S., acupuncture typically costs about $100 per session.

One of the positive aspects of acupuncture is that after an operation, a patient may choose to drive home, which is not possible with other treatments, such as general anesthesia, Rosted said

“The risk of causing harm with this treatment is nearly non-existent,” he said.

SOURCE: bit.ly/1h3eEAt Acupuncture in Medicine, online November 5, 2013.

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