First U.S. Patients Treated with Focused Ultrasound for Parkinson’s Disease

Newswise, September 2, 2015-- Researchers at the University of Maryland and the University of Virginia have performed the first focused ultrasound treatments in the United States for dyskinesia associated with Parkinson’s disease.

These treatments are part of international pilot studies of 40 patients assessing the feasibility, safety and preliminary efficacy of MR-guided focused ultrasound pallidotomy for dyskinesia that occurs with Parkinson’s disease.

Investigators are using magnetic resonance imaging (MR) to guide ultrasound waves through the intact skin and skull to reach the globus pallidus, a structure deep in the brain. 

If successful, focused ultrasound could offer an alternative approach for certain patients with Parkinson’s disease who have failed medical therapy or become disabled from medication-induced dyskinesia. To date, seven patients in Korea and one patient in Canada have been treated in studies.

“We are excited to offer our patients a new, non-invasive therapy to control their Parkinson’s symptoms,” said Howard M. Eisenberg, MD, Chair of Neurosurgery at the University of Maryland School of Medicine. 

“The neurology community has made significant strides in helping patients with Parkinson’s over the years; utilization of MR-guided focused ultrasound could help limit the life-altering side effects like dyskinesia to make the disease more manageable and less debilitating.”

“This opens up a new frontier for focused ultrasound therapy, building upon previous research which suggests that focused ultrasound can alleviate essential tremor,” said Jeff Elias, MD, Professor of Neurological Surgery at the University of Virginia. 

Dr. Elias led the Focused Ultrasound Foundation-funded pilot trial which investigated focused ultrasound for essential tremor (ET). The ET study results were published in the New England Journal of Medicine, and led to a larger pivotal trial, which was recently completed. 

In addition, enrollment has just completed in a pilot study assessing focused ultrasound for tremor-dominant Parkinson’s disease.

The Parkinson’s dyskinesia studies are being conducted using the ExAblate Neuro system developed by Insightec. 

“This is another major achievement in the development of focused ultrasound, which is under investigation to provide less invasive relief to patients suffering from movement disorders. We congratulate the teams in Maryland and Virginia for their pioneering spirit and support of the technology,” said Eyal Zadicario, Vice President for R&D and Director of Insightec’s Brain Program.

Funding for the Parkinson’s dyskinesia studies has been provided by the Focused Ultrasound Foundation and The Michael J. Fox Foundation for Parkinson’s Research, in collaboration with Insightec as regulatory sponsor. 

Eligible patients will include those whose medication has failed to satisfactorily control dyskinesia, who are not candidates for surgery or who choose not to undergo surgery. If the trials are successful, a large study is planned in advance of seeking FDA approval and reimbursement of focused ultrasound to treat Parkinson’s disease.

“This milestone marks an important step forward in the development of focused ultrasound as an alternative for Parkinson’s and other movement disorders as well as brain tumors,” said Foundation Chairman Neal F. Kassell. 

“This progress reflects the work of many innovative minds and the collaboration of several organizations committed to advancing paradigm-shifting solutions.”

About Parkinson’s Disease & Dyskinesias
Parkinson's disease, which results from the death of nerve cells in the brain, is a chronic, degenerative neurological disorder. It affects more than 5 million people worldwide. Since the risk of developing the disease increases with age, research indicates that one in 100 people over the age of 60 suffer from this debilitating disease.

Dyskinesias are involuntary movements that can become embarrassing and/or disabling. They represent a common and problematic complication of the medical treatment of PD using drugs such as levodopa. Management of dyskinesias with medications is challenging and often unsatisfactory.

About Focused Ultrasound for Parkinson’s

Magnetic resonance (MR)-guided focused ultrasound is a non-invasive method to destroy a small volume of targeted tissue in the globus pallidus region of the brain to both improve motor symptoms and reduce dyskinesias. 

Focused ultrasound treatment is performed with the patient awake and involves neither anesthesia, incisions in the skull, nor insertion of electrodes into the brain, thus decreasing the risk of complications such as injury to brain tissue, infections, hemorrhages or blood clots.

About Focused Ultrasound

Focused ultrasound is a revolutionary, early-stage therapeutic technology with the potential to transform the treatment of many serious medical disorders. 

This breakthrough technology uses ultrasonic energy guided by magnetic resonance or ultrasound imaging to treat tissue deep in the body without incisions or radiation. 

Multiple intersecting beams of ultrasound are directed and concentrated on a target as small as a grain of rice, much like a magnifying glass can focus multiple beams of light on a single point.

Focused ultrasound is currently approved in the U.S. to treat uterine fibroids and bone metastases, and there are a growing number of clinical applications in various stages of research and development around the world, including Parkinson’s disease, essential tremor, neuropathic pain, breast and prostate cancer, and brain tumors.

The Focused Ultrasound Foundation was created to improve the lives of millions of people worldwide by accelerating the development of focused ultrasound. Since its establishment in 2006, the Foundation has become the largest non-governmental source of funding for focused ultrasound research. More information can be found atwww.fusfoundation.org.

Surge in Bicycle Injuries to Riders Over 45

Cycling renaissance causing more hospitalizations in older adults

Newswise, September 2, 2015 — The incidence of bicycle accidents has increased significantly in the U.S. in recent years, with many serious injuries occurring among riders older than 45, according to a new study led by UC San Francisco.

The researchers used a national injury surveillance database to study trends in bicycle injuries from 1998 to 2013. They found that the rate of hospital admissions associated with bicycle injuries more than doubled during that timeframe, especially with head and torso injuries.

Altogether, the proportion of injuries occurring to riders above age 45 rose 81 percent, from 23 percent to 42 percent, the authors said, and similarly the proportion of hospital admissions to older riders increased 66 percent, from 39 percent to 65 percent.

The results are published in the September 1, 2015 edition of JAMA, the Journal of the American Medical Association.

“These injuries were not only bad enough to bring riders to the emergency room, but the patients had to be admitted for further care,” said senior author Benjamin Breyer, MD, MAS, associate professor of urology at UCSF and chief of urology at UCSF partner hospital San Francisco General Hospital and Trauma Center. 

“If you take typical 25-year-olds and 60-year-olds, if they have a similar crash, it’s more likely the older person will have more severe injuries.”

Urban cycling has become increasingly popular in recent years for both recreation and work, and this trend has occurred while the U.S. shifts to an older demographic.

In the new study, the researchers found that the percentage of injured cyclists with head injuries rose from 10 percent to 16 percent. Approximately two thirds of the total injuries occurred among men, the authors said, and there was “no significant change in sex ratio over time.”

“These injury trends likely reflect the trends in overall bicycle ridership in the United States in which multiple sources show an increase in ridership in adults older than 45 years,” the authors said. 

“Other possible factors … include an increase in street accidents and an increase in sport cycling associated with faster speeds.”

The authors say their findings highlight the need for more safe riding practices and better infrastructure to prevent cycling-related injuries.

“Bicycle riding provides a fantastic way to get exercise and it has a low impact on joints,” said Breyer. 

“Previous research has shown it has broad health benefits with reduced mortality. But on a national level, we need expanded support for improving the general infrastructure for cycling, especially bike lanes. 

"And all cyclists should be aware of the risks and take appropriate precautions such as using appropriate safety gear, including helmets, and they should follow the rules of the road.”

Data were derived from the National Electronic Injury Surveillance System.

Co-authors are Thomas Sanford, MD, a resident physician in urology; Charles McCulloch, PhD, a UCSF professor and vice chair of the department of epidemiology and biostatstics; Rachael Callcut, a UCSF assistant professor of surgery; and Peter R. Carroll, MD, MPH, chair of the UCSF Department of Urology and leader of the prostate cancer program at the UCSF Helen Diller Family Comprehensive Cancer Center.

Breyer is supported by grant K12DK083021 from the National Institute of Diabetes and Digestive and Kidney Diseases. Callcut is supported by grant 8KL2TR000143-09 from the National Institutes of Health.

About UCSF: UCSF is a leading university dedicated to transforming health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. 

Founded in 1864 as a medical college, UCSF now includes top-ranked graduate schools of dentistry, medicine, nursing and pharmacy; a graduate division with world-renowned programs in the biological sciences, a preeminent biomedical research enterprise and top-tier hospitals, UCSF Medical Center and UCSF Benioff Children's Hospitals. Please visit www.ucsf.edu/new

Big Differences in U.S. Healthcare Costs for Fixing Back Pain

Newswise — September 2, 2015 - How much does spinal fusion surgery cost? The answer depends on what part of the country you live in, reports a study in the September 1 issue of Spine, published by Wolters Kluwer.

Costs for spinal fusion vary substantially by region, with costs being lowest in the Midwest and highest in the Northeast, according to the new research by Dr. W. Ryan Spiker and colleagues of University of Utah, Salt Lake City. 

They write, "This data sheds light on the actual cost of common surgeries throughout the United States, and will allow further progress towards the development of cost effective, value driven care."

New Data on 'Actual Costs' of Common Spine Surgeries

The researchers analyzed 2012 Medicare data on the costs of two common types of spinal fusion surgery: anterior cervical discectomy and fusion (ACDF) and posterior lumbar fusion (PLF). These two operations are widely performed in patients with patients with pain and/or instability in the upper (ACDF) and lower (PLF) spine.

For comparison, the costs of total knee arthroplasty (TKA)—another common orthopedic procedure, not involving the spine—were assessed as well. 

The analysis focused on direct costs, defined as the amount reimbursed to health care providers (such as surgeons or hospitals) by Medicare or other payers. Most previous economic analyses of spinal surgery have focused on charges—the amount billed by providers to payers.

Average national costs were about $14,000 for a single-level ACDF procedure and $26,000 for a single-level PLF. (These total figures reflected combined professional and facility costs.) Average cost for KA was about $13,000, increasing to $22,000 for TKA in patients with accompanying other major medical conditions.

"Each procedure had a significant range in cost across the country," Dr. Spiker and coauthors write. Costs for ACDF ranged from about $11,000 to $25,000, while PLF costs ranged from $20,000 to $37,000. For TKA patients without major medical conditions, the range was from about $11,000 to $19,000.

All procedures except ACDF also showed significant variations on the regional level—with the lowest costs in the Midwest and highest costs in the Northeast. For PLF, costs ranged from $24,000 in the Midwest to $28,000 in the Northeast. 

The figures were $12,000 versus $14,000 for primary TKA, and $21,000 versus $25,000 for TKA with major medical conditions.

On the state level, total costs for all four procedures were significantly correlated with the state's cost of living index, but not with state population.

Spinal fusion procedures such as ACDF and PLF are a major source of costs for Medicare and other payers. 

From 2001 to 2010, an estimated 3.6 million spinal fusions were performed in the United States, with total charges of more than $287 billion.

The new study is one of the first to provide information on the costs of spinal fusion surgery, rather than charges. Reported total charges for these procedures are about twice as high as the average costs, Dr. Spiker and colleagues note.

The results show substantial variations in the costs paid by Medicare for spinal fusion surgery. The TKA cost data show that the variations are not limited to spinal surgery.

The study does not show what's behind the variations in cost, although state cost-of-living index is one related factor. 

Dr. Spiker and coauthors write, "In the pursuit of cost optimization, and the broader pursuit of value driven healthcare, it may prove valuable to study the factors that allow these states to deliver care at a lower cost."

Flu Study, on Hold, Yields New Vaccine Technology

Newswise, September 2, 2015 – Vaccines to protect against an avian influenza pandemic as well as seasonal flu may be mass produced more quickly and efficiently using technology described today (Sept. 2) by researchers at the University of Wisconsin-Madison in the journal Nature Communications.

The new method for making flu vaccines using cell culture was devised using a type of research that has since been paused by the federal government, which is formulating regulations for how some viruses can be manipulated. 

The finding emphasizes the value of such research, says Yoshihiro Kawaoka, the professor of pathobiological sciences whose group performed the work.

Currently, most flu vaccines are manufactured using fertilized chicken eggs as crucibles to grow vaccine viruses — viruses that are a good match for anticipated seasonal or pandemic flu strains. 

Flu viruses are grown in the eggs, deactivated with chemicals, and purified to create the raw material for a vaccine.

However, because avian influenza can strike the flocks used to produce the millions of eggs required worldwide to make vaccines, serious outbreaks of avian flu could impede vaccine production.

New seasonal flu vaccines must be produced each year. Vaccines to protect against more worrisome potential pandemic strains of avian influenza are mass produced and stockpiled every few years based on surveillance of the ever-evolving strains of avian flu circulating in fowl worldwide.

Another key drawback to the use of chicken eggs is that the antigenic qualities of the vaccine virus, chosen to be as close a match as possible for an anticipated strain of flu, can change during incubation. 

The result is a less effective vaccine, such as the one widely used for the 2014-15 flu season, which was less effective due to changes in the circulating virus itself as well as antigenic changes to the vaccine virus propagated in eggs. Moreover, the new technology promises vaccines that do not pose a problem for those who are allergic to eggs.

Technology to produce flu vaccines using mammalian cell cultures already exists, but in its current form is less efficient than making vaccines in eggs.

The new high-yield method was devised by Kawaoka’s group before the federal government imposed a moratorium on such work in October 2014. 

Contributing significantly to the work was Jihui Ping, a research scientist in the UW-Madison School of Veterinary Medicine.

“Depending on the strain, we can get between a twofold and tenfold increase in production using mammalian cells,” Kawaoka says. “Even a twofold increase is substantial for vaccine production.”

In addition to sidestepping the limitations of egg-based vaccine production, the technology is potentially more nimble as vaccine production can be altered or ramped up more easily. 

“You can scale up cell-based vaccine production very quickly,” explains Kawaoka, one of the world’s foremost experts on influenza.

The new technology hinges on viruses engineered to replicate more efficiently in mammalian cells. By looking for genetic mutations that foster more efficient growth in cells and building those systematically into a backbone vaccine virus, the Wisconsin group was able to produce the high-yield vaccine viruses.

“We simply looked for strains that grow well in mammalian cells and picked those mutations that contribute to high yield,” Kawaoka explains.

A patent for the new high-yield vaccine technology is being sought by the Wisconsin Alumni Research Foundation (WARF). Commercialization of the new method for making flu vaccines could help fuel a switch from egg-based vaccine production, according to Kawaoka.

“Existing strains of flu vaccine virus don’t grow well in cells and there is only one company in the United States currently using cell-based production methods,” notes Kawaoka. 

“But there is a trend toward cell-based production and we think this work can contribute to that.”

The study was supported by grants from the National Institutes of Health; WARF; the Japanese Ministry of Education, Culture, Sports, Science and Technology; and the Bill and Melinda Gates Foundation.

Why Does Running Make Us Happy?

Newswise, September 2, 2015 — The joy of running. That sense of well-being, freedom and extra energy that runners often experience is not just a matter of endorphins. A study at the University of Montreal Hospital Research Centre (CRCHUM) shows that the "runner’s high" phenomenon is also caused by dopamine, an important neurotransmitter for motivation.

"We discovered that the rewarding effects of endurance activity are modulated by leptin, a key hormone in metabolism. Leptin inhibits physical activity through dopamine neurons in the brain", said Stephanie Fulton, a researcher at the CRCHUM and lead author of an article published today in the journal Cell Metabolism.

Secreted by adipose tissue, leptin helps control the feeling of satiety. This hormone also influences physical activity. 

"The more fat there is, the more leptin there is and and the less we feel like eating. Our findings now show that this hormone also plays a vital role in motivation to run, which may be related to searching for food", explained Stephanie Fulton, who is also a professor at Université de Montréal’s Department of Nutrition.

Hormone signals that modulate feeding and exercise are in fact believed to be closely linked. Endurance running capacity in mammals, particularly humans, is thought to have evolved to maximize the chances of finding food. 

This study suggests that leptin plays a critical role both in regulating energy balance and encouraging behaviours that are "rewarding" for the person’s metabolism, i.e., engaging in physical activity to find food.

The researchers studied voluntary wheel running in mice in cages. These mice can run up to seven kilometres a day. 

In a laboratory, the physical activity of normal mice was compared with that of mice who underwent a genetic modification to suppress a molecule activated by leptin, STAT3 (signal transducer and activator of transcription-3). The STAT3 molecule is found in the neurons that synthesize dopamine in the midbrain. 

This “mesolimbic dopaminergic pathway” is a like a motivational highway in the brain.

"Mice that do not have the STAT3 molecule in the dopaminergic neurons run substantially more. 

Conversely, normal mice are less active because leptin then activates STAT3 in the dopamine neurons, signalling that energy reserves in the body are sufficient and that there is no need to get active and go looking for food", explained Maria Fernanda Fernandes, first author of the study.

And is leptin as important for motivation to be active in humans? Yes. 

"Previous studies have clearly shown a correlation between leptin and marathon run times. The lower leptin levels are, the better the performance. Our study on mice suggests that this molecule is also involved in the rewarding effects experienced when we do physical exercise. 

"We speculate that for humans, low leptin levels increase motivation to exercise and make it easier to get a runner’s high", summed up Stephanie Fulton.

Mice, humans and mammals in general are thought to have evolved to increase the return on effective food acquisition behaviours. Ultimately, hormones are sending the brain a clear message: when food is scarce, it’s fun to run to chase some down.

About the study

The study “Leptin suppresses the rewarding effects of running via STAT3 signaling in dopamine neurons” was published in Cell Metabolism. Financial support: Stephanie Fulton is a recipient of a Canadian Institutes of Health Research New Investigator Salary Award; Thierry Alquier is a recipient of a salary award from the Fonds de recherche du Québec – Santé (FRQS); Maria Fernanda Fernandes, now a post-doctoral fellow at the University of Guelph (Ontario), is a recipient of a doctoral fellowship from the Canadian Diabetes Association and the Department of Physiology, Université de Montréal.

The other authors are: Dominique Matthys, Cécile Hryhorczuk, Sandeep Sharma and Shabana Mogra. To find out more, see the study at this link:
http://www.cell.com/cell-metabolism/abstract/S1550-4131(15)00394-0

Manage AFib Risk for Better Health

September 1, 2015--(Family Features) Approximately 1.5 million American women live with atrial fibrillation, a heart disorder commonly known as “AFib” that can lead to deadly or life-impairing stroke. For an undiagnosed woman living with AFib, knowing symptoms and risk factors can help mitigate this serious health threat. Women living with AFib can also take steps to manage this condition and their risk for stroke.  

AFib is a heart rhythm disorder in which the atria – the two upper chambers of the heart – beat rapidly and irregularly. Women with AFib are more likely than men with AFib to have a stroke. And, after the age of 75, an overwhelming majority of people with AFib – 60 percent – are women.

Diagnosing the condition

Up to a third of women with AFib don't feel symptoms. Others feel tired and experience heart palpitations, which may feel like a fluttering or flopping sensation in the chest or the feeling that the heart is beating too quickly. A woman experiencing AFib may also feel dizzy or short of breath. Some feel chest pain or feel faint.

Certain health and lifestyle risk factors make women more susceptible to AFib. Along with age and an existing heart condition, high blood pressure and obesity are major risk factors. Women who drink more than 10 ounces of alcohol a day are also at risk. Other risk factors include diabetes, overactive thyroid, high blood pressure, sleep apnea, lung disease, smoking, caffeine and stress.

With or without elevated risk factors, a woman experiencing symptoms should schedule a consultation with a doctor to determine if these symptoms are caused by AFib.

Living with AFib

Women living with AFib can manage their condition and associated risk for stroke by adopting healthy lifestyle behaviors. Increasing physical activity, adopting a diet that is low in fat, sodium and cholesterol, avoiding alcohol, and moderating stress and blood pressure levels are all necessary to manage AFib and avoid more serious health problems. AFib patients should choose caffeine-free coffee and herbal tea over caffeinated drinks. Moderate exercise such as walking, biking, swimming, yoga and strength training, combined with good hydration, can significantly improve AFib symptoms and reduce stroke risk. 

Isolation is a common feeling for women living with AFib. Resources such as WomenHeart’s new Virtual Support Network can help address the need for education and emotional and psychosocial support for women living with AFib. The Network is free and open to all women living with AFib and their caregivers.

Learn more about WomenHeart’s free patient support services for women living with heart disease, including AFib, and register to receive free online heart health information at www.womenheart.org.

  

Transcatheter Aortic Valve Replacement Is Safe, Effective for Very Elderly Patients

Results show that age alone should not eliminate TAVR as treatment option

Newswise, September 1, 2015--Select patients age 90 years and older with aortic stenosis (AS) can benefit from a relatively new, minimally invasive surgery for aortic valve replacement, according to an article in the September 2015 issue of The Annals of Thoracic Surgery.

As part of the PARTNER-I trial, Vinod H. Thourani, MD, from Emory University in Atlanta, and colleagues from 12 other institutions in the United States found that transcatheter aortic valve replacement (TAVR) is a safe and effective way to treat aortic stenosis in nonagenarians who qualify for the surgical technique.

“Historically, extreme elderly patients can be at a very high risk for open surgery,” said Dr. Thourani.

“We still believe that for those 90 year olds who are low-or intermediate risk, surgical options may be a viable procedure. However, with the advent of TAVR technology, we can now offer these extreme elderly patients a treatment option that otherwise would have been high-risk or prohibitive.”

Aortic stenosis is the most common acquired valve disease in elderly patients and affects nearly 3% of those over the age of 75, according to the American Heart Association.

The ability to safely treat AS patients has become increasingly important; the US government predicts that the number of Americans over the age of 85 will exceed 11 million in the next 20 years.

For the study, the researchers used two different approaches: transfemoral TAVR (TF-TAVR), which is the traditional approach performed via the groin, and transapical TAVR (TA-TAVR), which is performed via the heart muscle. TA-TAVR is an alternative for patients who are medically ineligible for TF-TAVR secondary to severe peripheral vascular disease. While the current study did not evaluate other alternative options for TAVR, these techniques may include transaortic, transcaval, transcarotid, or trans-subclavian.

In the largest series published to date, between April 2007 and February 2012, 531 nonagenarians underwent TAVR: 329 with TF-TAVR and 202 with TA-TAVR.

“We evaluated perioperative, short-, and mid-term outcomes following both TF- and TA-TAVR,” explained Dr. Thourani.

“Compared with an age-sex-race–matched US population, the TAVR patients had a comparable risk of mortality, and quality of life improved within 6 months of the procedure. Our study shows that age alone should not preclude referral for TAVR in patients age 90 years and older.”

The study also showed that the 30-day stroke risk was 3.6% in TF-TAVR patients and 2.0% in TA-TAVR patients. Major complications, such as bleeding or vascular issues, occurred in 35% of TF-TAVR patients and 32% of TA-TAVR patients, and more than 80% of patients were discharged home after the procedure.

“Future studies are needed to address potential differences in outcomes between TF- and TA-TAVR groups,” said Dr. Thourani, “but I’m thrilled that we’re able to give elderly people the chance to continue enjoying life in their golden years. Many would not have had that option without TAVR.”

The Annals of Thoracic Surgery is the official journal of STS and the Southern Thoracic Surgical Association. It has a 5-year impact factor of 4.104, the highest of any cardiothoracic surgery journal worldwide.