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Landmark Study Shows Clot Removal Reduces Mortality, Improves Patient Outcome in Large-Vessel Stroke

PITTSBURGH, Feb. 11, 2015 – Researchers have completed an international, randomized, controlled trial showing that a clot-retrieval procedure, known as endovascular treatment (ET), can dramatically improve patient outcomes after an acute ischemic stroke. The study, in which the University of Pittsburgh enrolled more participants than any other American site, also shows a dramatic reduction in deaths from stroke. The results were published in the Feb. 11 online edition of the New England Journal of Medicine (NEJM).

The results of this landmark study will be published in the March 19 print edition of NEJM and presented at the American Heart Association’s International Stroke Conference in Nashville, Tenn.

Overall, positive outcomes for patients increased from 30 percent to 55 percent. In many cases, instead of suffering major neurological disability, patients went home to resume their lives. Led by researchers at the University of Calgary, the study found that overall mortality rate was reduced from two in 10 patients for standard treatment of care to one in 10 patients – a 50 percent reduction with ET.

“These results mean we are on the verge of a revolution in stroke care,” said Tudor Jovin, M.D., associate professor of neurology and neurological surgery, director of the UPMC Stroke Institute and leader of the Pitt arm of the study. “This is a devastating condition from the standpoint of death and disability. Finally, we are able to offer these patients a treatment that really works.”

Ischemic stroke is caused by a sudden blockage of an artery to the brain that deprives the brain of critical nutrients, such as glucose and oxygen. Currently, the international standard of care based on Canadian, U.S. and European guidelines is to administer a “clot buster” drug called tPA, to attempt to dissolve the blood clot.

In this trial, known as ESCAPE (Endovascular treatment for Small Core and Anterior circulation Proximal occlusion with Emphasis on minimizing CT to recanalization times), 316 patients who fit the criteria for ET and arrived for treatment within 12 hours of their stroke were randomly assigned to receive either standard medical care, which included tPA where appropriate, or standard medical care plus ET.

ET is performed by inserting a thin tube into the artery in the groin through the aorta and into the brain vessels to the clot using X-ray-guided imaging. A retrievable stent opens the blocked vessel to restore blood flow and then withdrawn, pulling the clot out with it.

Endovascular treatments were first developed in the 1990s, but ET has only recently been technically possible. The ESCAPE team says the success of the trial can be credited to very fast treatment and the use of brain and blood vessel imaging. Researchers were on average two hours faster in opening the blocked blood vessels than in previously reported trials.

ESCAPE is the second ET trial that demonstrates the efficacy of the treatment and the first trial to demonstrate reduced mortality. The previous trial, known as MR. CLEAN (Multicenter Randomized Clinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands), was published in NEJM in December 2014.

ESCAPE included 22 sites worldwide and patients in the U.S., U.K., Ireland and South Korea. Canada had 11 participating hospitals and enrolled two-thirds of the patients.

“This was a trial that was very carefully designed to tell us for certain whether endovascular therapy should play a role in the treatment of stroke patients,” said co-investigator Lawrence Wechsler, M.D., Henry B. Higman Professor and chair, Department of Neurology, Pitt School of Medicine, and the institute’s founding director. “The UPMC Stroke Institute is a leader in advancing stroke care, and we encourage our patients to take advantage of the opportunity to participate in important clinical trials like this one.”

The study was funded by The Heart and Stroke Foundation of Canada, Alberta Innovates-Health Solutions and Medtronic, along with generous donations to the Calgary Stroke Program.

View a video of Dr. Jovin performing the ET procedure: http://youtu.be/s7wY9RgAFTk

Pitt Team Developing Technology to Allow Amputees to Feel with Prosthetic Limb, Improving Its Function

PITTSBURGH, Feb. 10, 2015 – Rehabilitation experts at the University of Pittsburgh School of Medicine hope to one day give people with an arm amputation a prosthetic limb that not only moves like a natural one, but “feels” like it, too. They expect such sensation will improve dexterous control of the device and give users greater intuition about what they are doing with their prosthetic.

With funding from the Defense Advanced Research Projects Agency (DARPA)’s Hand Proprioception and Touch Interfaces (HAPTIX) program, Robert Gaunt, Ph.D., assistant professor, Department of Physical Medicine and Rehabilitation (PM&R), Pitt School of Medicine and a multidisciplinary research team from Pitt, West Virginia University and Ripple LLC will begin developing the technology with the aim of being able to test it in patients’ homes within four years.

“Advanced prosthetic limbs that behave like the hand and arm they are replacing have been an unrealized promise for many years largely because until recently, the technologies to really accomplish this goal simply haven’t been available,” Dr. Gaunt said. “To make the most of these new capabilities, we have to integrate the prosthetic into the remaining neural circuitry so the patient can use it like a regular hand that, for example, can pick up a pen, gently hold an egg or turn a stuck doorknob.”

In the 18-month, first phase of the project, the team will recruit five volunteers to try to demonstrate that stimulation of the sensory portion of the spinal cord nerves, which would normally innervate the hand and forearm, can cause the amputee to feel distinct sensations of touch and joint movement in the “phantom” hand and wrist.

They also plan to insert fine-wire electrodes into the forearm muscles of able-bodied volunteers to collect and interpret muscle signals to guide movement of a virtual prosthetic hand to control hand opening and closing, as well as thumb movement. Eventually, the team aims to devise a fully implantable system for home use.

Michael Boninger, M.D., PM&R professor and chair, who will co-direct the project with Dr. Gaunt, called it a very exciting study.

“In my treatment of rehabilitation patients, the goal is always clear,” Dr. Boninger said. “They want the medical team to make them like they were. The technology developed through HAPTIX will enable that dream.”

The project will be conducted by a multidisciplinary team of engineers, scientists and clinicians from PM&R, plastic surgery, and neurological surgery in the School of Medicine, and occupational therapy, and rehabilitation science & technology in the School of Health and Rehabilitation Sciences at the University of Pittsburgh. Key aspects of the system will be designed by researchers at West Virginia University, and Ripple LLC, in Salt Lake City, Utah, will develop all the implantable system components.

Funding for the research was made possible by an award from the BRAIN Initiative, a White House program launched to revolutionize understanding of the brain and accelerate the development of new technologies. The National Institutes of Health, the National Science Foundation, the Food and Drug Administration, and DARPA committed more than $110 million to the Initiative for fiscal year 2014.

Thomas Kleyman, MD, Selected to Give Distinguished Lectureship at American Physiological Society Meeting

PITTSBURGH, Feb. 10, 2015 – Thomas Kleyman, MD, chief of the Renal-Electrolyte Division at the University of Pittsburgh, has been chosen for the 2015 Carl W. Gottschalk Distinguished Lectureship of the American Physiological Society (APS) Renal Section at Experimental Biology (EB) 2015 in Boston from March 28–April 1. The award recognizes a world-renowned, distinguished scientist who has made major contributions to understanding physiological processes through state-of-the-art research, and who is an engaging speaker. The candidate’s area(s) of research expertise also is of interest to Renal Section members.

In addition to delivering the Carl W. Gottschalk Distinguished Lecture, Dr. Kleyman will participate in the Renal Section’s Posters and Professors Reception and will be recognized at the Renal Dinner held during EB 2015.

For more information on the lectureship and Experimental Biology 2015, please visit the American Physiological Society’s website.

Pediatric Rehabilitation Chief to Serve on IOM Committee

PITTSBURGH, Feb. 9, 2015 – Amy Houtrow, MD, PhD, MPH, chief, Division of Pediatric Rehabilitation Medicine and a member of the Brain Care Institute, recently was asked to serve on the Institute of Medicine’s (IOM) Standing Committee of Medical Experts to Assist Social Security on Disability Issues. Dr. Houtrow was chosen for the committee because of her work on the IOM’s Consensus Committee on Social Security for Children with Mental Health Disabilities.

Dr. Houtrow is board certified in physical medicine and rehabilitation and pediatrics. Her clinical focus is on children with disabling conditions and improving their function and quality of life. Dr. Houtrow is the youngest member of the committee and the only representative from the field of pediatric rehabilitation.

The IOM committee will assist the Social Security Administration in improving its criteria for determining disability in adults and children. It will survey literature, clinical practices, and published studies related to disability, and collect and analyze relevant data and information. It also will organize and lead outreach conferences with members of the public to provide a neutral ground for the debate and analysis of emerging disability issues. The work of the committee has the potential to impact the lives of millions of children and adults with disabilities.

For more information on the Standing Committee of Medical Experts to Assist Social Security on Disability Issues, please read the full activity description on the IOM website.

Primary Care-Based Program Helps Overweight, Middle-Aged Women Increase Physical Activity

PITTSBURGH, Feb. 9, 2015–Getting help from the family doctor may be a better way for overweight, middle-aged women to increase their physical activity, rather than trying to go it alone, according to a trial led by researchers at the University of Pittsburgh School of Medicine and funded by the National Institutes of Health (NIH).  Obesity and physical inactivity are significant risk factors for cardiovascular disease in middle-aged women.

The results, available online in the February issue of the Journal of General Internal Medicine, show that obese, middle-aged women who participated in an exercise program based at their primary care doctor’s office were more likely to continue to exercise over several months compared with those who were self-guided.

“Women who participated in programs in their doctor’s office had a structured environment allowing them to focus on their lifestyle habits like eating and exercising, and make changes,” said Molly Conroy, M.D., M.P.H., associate professor of medicine, epidemiology, and clinical and translational science at Pitt.

The Healthy Bodies Healthy Hearts investigators enrolled 99 inactive, overweight women ages 45 through 65 at three UPMC primary care offices at UPMC Montefiore, UPMC Shadyside and Magee-Womens Hospital of UPMC. The women were randomly separated into two groups: one in which they participated in 12 weekly sessions at their primary care physician’s office consisting of 30 minutes of discussion and 30 minutes of moderate-intensity exercise; and a self-guided group that received a manual for independent use.

After three months, assessments showed that the women in the interventionist-led group had significantly higher levels of physical activity, such as walking at a moderate pace, with improvements equal to about 90 minutes per week, compared to the self-guided women who improved by only about 30 minutes per week.

After a year, both groups reduced their level of activity. The self-guided participants returned to pre-intervention activity levels; however, the interventionist-led women were still more active than they had been before participation by about 60 minutes of exercise per week.

“These outcomes imply that primary care-based interventions can be very beneficial to keep sedentary women motivated for several months. Many indicated their confidence was higher and that they felt more comfortable exercising with support. Follow-up sessions could help women over the long-term,” said Dr. Conroy. “Future efforts should focus on finding the best way to sustain that activity, using resources available in the primary care setting.”

Co-authors of the study include Kathleen L. Sward, Ph.D., M.P.H., of Heartchange; Kathleen Spadaro, Ph.D., of Chatham University; and Dana Tudorascu, Ph.D., Irna Karpov, M.S., Bobby L. Jones, Ph.D., Andrea M. Kriska, Ph.D., and Wishwa N. Kapoor, M.D., M.P.H., all of Pitt.

The study was sponsored by NIH National Heart, Lung and Blood Institute grant K23 HL 085405.

Pitt Physical Therapy, Health Policy Institute Key to Novel, National Research-Training Initiative

PITTSBURGH, Feb. 5, 2015 – With the first-ever grant to train future researchers and scientists in the physical therapy field, the University of Pittsburgh School of Health and Rehabilitation Sciences, and Pitt Health Policy Institute will partner with Brown and Boston universities on a five-year, $2.5 million program that, at Pitt, will focus on generating pilot studies.

The Foundation of Physical Therapy, in an announcement made this afternoon to coincide with the American Physical Therapy Association convention in Indianapolis, Ind., awarded the grant to Brown to establish the Center on Health Services Training and Research. CoHSTAR will offer multi-institutional research and a built-in training program where each university will focus on specific areas of health services: Brown on large database analysis, Boston on outcome measurement, and Pitt on quality assurance and implementation.

Pitt’s Tony Delitto, Ph.D., chair of the Department of Physical Therapy in the School of Health and Rehabilitation Sciences (SHRS), and professor Kelley Fitzgerald, Ph.D., will serve as co-directors overseeing the Pilot Studies Core. There are three funded pilot studies expected to start as soon as this summer, and Drs. Delitto and Fitzgerald said they plan to fund three new pilot projects each of the remaining four years of the grant, earmarking them at a base funding of $100,000 total per year. The amount of funding Pitt receives will vary according to their number of fellows, trainees and projects.

“Funding for these pilot studies is critically important to develop researchers whose evidence will inform policymaking to support new, more effective and patient-centered models of healthcare delivery. The partnership established by the Foundation of Physical Therapy is a structure that will ultimately speed innovation and dissemination of research findings,” said Everette James, J.D., M.B.A., director of Pitt’s Health Policy Institute. Faculty from the institute will serve as co-investigators and consultants on the Pilot Studies projects.

Dr. Delitto added that the Affordable Care Act makes research and subsequent long-term policy perspectives even more vital to the field: “Physical therapy is like a lot of other health professions – the training in health services research has lagged. With health reform, everyone sees the value of health-services research. We’ve demonstrated that we can do this kind of work and carry it through to health policy. The path is there. Pitt across its campus has a reputation for that, and so does Brown and Boston universities, which makes for good synergy.”

Three pilot programs will be launched this summer, with one headquartered at Pitt:

  •  James Irrgang, Ph.D., with Dr. Fitzgerald among his co-investigators, will develop and pilot test a nationwide registry of patients receiving care for non-operative knee pain. Such a database could affect trials, research, care and insurance policymaking.
  • Julie Fritz, who earned her Ph.D. at Pitt under Dr. Delitto in 1998 and conducted research at SHRS, will be the principal investigator on a study at the University of Utah to examine if physical therapy should become the first point of care for patients with lower-back pain.
  • Christine McDonough, Ph.D., of Boston will direct a study to attempt to find statistical methods for functional assessment to better evaluate Medicare post-acute care and physical therapy.

Live Like Lou Center for ALS Research at Pitt Brain Institute Will Search for Treatments, Cure

PITTSBURGH, Feb. 5, 2015 – The University of Pittsburgh today announced the creation of the Live Like Lou Center for ALS Research, and that O’Hara Township couple Neil and Suzanne Alexander have pledged to raise half of its initial funding. The new center will focus both on developing new treatments and, ultimately, a cure for amyotrophic lateral sclerosis (ALS) and on improving the quality of life for people who are now living with the progressive, degenerative neurological condition, also known as Lou Gehrig’s Disease.

The Alexanders established Live Like Lou at the Pittsburgh Foundation in 2011, soon after Mr. Alexander was diagnosed with ALS at age 46. They have pledged to raise $2.5 million over five years. Pitt has matched the contribution as part of an effort to raise $10 million for the new research center, which will be located in Pitt’s year-old Brain Institute.

“We are honored to be chosen as partners in this effort by the Alexander family,” said University of Pittsburgh Chancellor Patrick Gallagher. “Their dedication to helping others with this debilitating disease is inspirational. We are looking forward to putting the resources and expertise of the University to work on this task, and we are honored that they have chosen the University of Pittsburgh as the site for this center.”

Currently, there is no effective treatment for ALS, which causes progressive paralysis and eventually makes swallowing and breathing difficult, if not impossible, while sensation and cognitive function remain unaffected. Patients with ALS live two to five years after diagnosis, on average, with about 10 percent surviving for 10 years or longer.

Mr. Alexander said that he is inspired by the dignity and perseverance shown decades ago by legendary Yankees first baseman Lou Gehrig, who died from ALS in 1941. A Hall of Famer for his work on the field, Gehrig is perhaps best remembered for his emotional farewell from baseball at age 36, when he gave a speech to a packed stadium in 1939, telling fans, “Today I consider myself the luckiest man on the face of this earth.”

“We call our effort Live Like Lou to honor the legacy Gehrig left for all of us who face this diagnosis,” said Mr. Alexander. “We want to live with the same gratitude and grace despite the disease.”

To start, the Live Like Lou Center will:

  • Recruit an expert in the neurobiology of ALS
  • Develop a non-human primate model of the disease
  • Create a prototype of a “smart house” to test neuro-technologies and neuro-prostheses in a real-life home setting
  • Explore brain-computer interface technology to foster patient independence
  • Support clinical trials to slow or reverse the progression of ALS
  • Award annual innovator grants to catalyze novel research approaches

Mr. Alexander said he chose the Brain Institute to be the site of the new research center because of Pitt’s history of accomplishment in neuroscience research and its translation of basic science into innovative solutions to clinical problems, exemplified by Jonas Salk’s polio vaccine. Pitt is where the gamma knife for minimally invasive brain surgery was introduced to neurosurgeons in North America, where Pittsburgh Compound B was developed for early detection of Alzheimer’s disease, and where a brain-computer interface first enabled a paralyzed woman to control a robotic arm to feed herself.

“It is a great honor to have this opportunity to combine the University’s vast experience and resources in neuroscience with the Alexanders’ commitment and passion,” said Arthur S. Levine, M.D., Pitt’s Senior Vice Chancellor for the Health Sciences and John and Gertrude Petersen Dean of Medicine. “Like them, we want to galvanize our scientists to pursue transformative avenues of research to find treatments – or better yet a cure – for this devastating disease.”

“The new center’s goals are bold,” said Peter L. Strick, Ph.D., Thomas Detre Professor and Chair of Neurobiology and scientific director of the Brain Institute. “We haven’t chosen easy targets. The Alexanders understand that we don’t have all the answers yet. Treatments and cures are going to come through basic research, and that is what our Brain Institute is designed for. But we also want to address the here and now and fund projects that will have a rapid payoff by improving the quality of life of ALS patients today.”

Mr. Alexander said that while ALS seems to take something away from him every day, living with the disorder also has highlighted the unwavering love and support he has from friends and family, especially his wife and their young children, Abby and Patrick.

“We don’t think this work will help me necessarily,” he said. “But we want to do this for the next guy, the next father who starts to get a twitch in his left arm.”

Contraceptive Counseling at Dermatologist’s Office Improves Knowledge of Effectiveness For Women Taking Acne Drug, Pitt Study Finds

PITTSBURGH, Feb. 4, 2014 – Providing women who take a powerful acne drug with a fact sheet about contraception while visiting the dermatologist can significantly improve their awareness of the most effective birth control options and may prevent unintended pregnancies and birth defects that can be caused by the drug, according to a University of Pittsburgh School of Medicine study published Feb. 4 in the journal JAMA Dermatology.

Isotretinoin, formerly marketed as Accutane, is an effective drug for the treatment of acne, but is also considered a teratogen, or a drug that can cause birth defects. Because of this, the Food and Drug Administration (FDA) strictly regulates the distribution of the drug to women of childbearing age. Through the FDA’s iPLEDGE program, woman who are prescribed the drug must pledge to use two forms of contraception, in addition to taking regular pregnancy tests while on the drug and online tests to make sure they understand the dangers of getting pregnant while taking the drug.

Despite the regulations, 122 pregnancies affected by isotretinoin were reported in the U.S. during the first year of the iPLEDGE program. Pitt researchers have been studying this and found gaps in patients’ knowledge about the most effective forms of contraception.

“While contraceptive counseling isn’t something a dermatologist has to do on a daily basis – like an obstetrician or gynecologist would – it does matter for young women using these drugs. Our goal was to show that a simple intervention like our handout could be added to dermatology office visits to enhance contraceptive counseling and decrease the number of exposed fetuses through more effective means of contraception,” said Carly A. Werner, M.D., a UPMC resident in the Department of Obstetrics, Gynecology and Reproductive Sciences and lead author on the study.

In the study, researchers surveyed 100 women from a single dermatology clinic between April and May 2014. Prior to viewing the contraceptive fact sheet, 75 percent overestimated the effectiveness of condoms, while 51 percent did the same for oral contraceptives. Thirty-four percent of women said they had never heard of contraceptive implants, and 16 percent had never heard of IUDs, or intrauterine contraceptive devices, despite their effectiveness being much higher than that of condoms and oral options.

Researchers surveyed those women again after they had reviewed the fact sheet and found significant improvement in knowing about contraceptives.

“This shows us that dermatologists can make a difference by providing women who take this drug more education regarding effective forms of contraception,” said Laura Ferris, M.D., Ph.D., director of clinical trials for UPMC’s Department of Dermatology, who was a co-author on the study.

The researchers recommended that future study is needed to determine how much the information provided on the fact sheet was retained and if it does reduce the risk of medication-induced birth defects.

Other collaborators were Melissa J. Papic, B.S., and Eleanor Bimla Schwarz, M.D., both with the University of Pittsburgh.

The study was funded in part by FDA grant U01FD004253-01.

Pediatric Neurology Researcher Receives NIH Grant

PITTSBURGH, Feb. 3, 2015 – Sharyl L. Fyffe-Maricich, PhD, assistant professor of pediatrics at the University of Pittsburgh School of Medicine, has been awarded an NIH Research Project Grant (R01) for her submission, “The Role of ERK1/2 MAP Kinase Signaling in CNS Myelination.” The grant was awarded on Dr. Fyffe-Maricich’s first submission, which is a high honor. Her immediate goal is to improve therapy for multiple sclerosis (MS) and other demyelinating diseases.

A member of the Society for Neuroscience, Dr. Fyffe-Maricich joined the Division of Child Neurology at Children’s Hospital of Pittsburgh of UPMC in 2013 and quickly established a highly productive lab. She was the focus of a recent documentary produced by the National Multiple Sclerosis Society about her research.

To see Dr. Fyffe-Maricich in the documentary, please visit the National Multiple Sclerosis Society’s YouTube page.

Personalized Medicine to Reduce Adverse Drug Outcomes in People with Mental Illness

PITTSBURGH, Feb. 3, 2015 – Geneticists at the University of Pittsburgh Graduate School of Public Health will provide their scientific expertise to a new initiative aimed at preventing and reducing the adverse effects of medications in people with mental illnesses.

The research project will take a personalized medicine approach to managing drug therapy by analyzing each patient’s genetic makeup to determine potential adverse reactions to medications. Funded by the Polk Foundation, it will be led by NHS Human Services, one of the nation’s largest providers of human services, in collaboration with Pitt Public Health; CareKinesis Inc., a medication therapy management services provider; and Coriell Life Sciences, a pharmacogenomics testing vendor.

“An individual’s genetic makeup defines how many common drugs are processed by the body and who is at risk for an adverse drug response from such therapies,” said Dietrich Stephan, Ph.D., professor and chair of the Department of Human Genetics at Pitt Public Health. “Individuals can suffer immensely from the very drugs that are meant to improve their health if given drugs they cannot tolerate, often resulting in increased emergency room visits and elevated health care costs.”

For example, some people are genetically predisposed to metabolize certain drugs faster than the average person, causing them to have a stronger, more immediate response to medication. When someone is prescribed multiple medications, such responses can cause unexpected and potentially dangerous drug interactions.

“The people at highest risk, such as the aged and mentally ill, often are prescribed a multitude of drugs with no insight into their genetic susceptibilities,” said Dr. Stephan, who also serves as associate director of the Institute for Personalized Medicine, a collaboration between Pitt and UPMC. “In this study, we aim to systematically implement comprehensive genetic testing in these populations and develop the evidence around improved outcomes and reduced costs that allows such testing to be broadly delivered to the general population and reimbursed by insurers. The Institute for Personalized Medicine, as part of UPMC, has the scale to be able to broadly implement pharmacogenomics to improve lives across a multitude of providers both nationally and internationally.”

Dr. Stephan serves as chair of the clinical advisory panel for the 28-month, $350,000 initiative, which is funded by a grant from the Polk Foundation to NHS Human Services Foundation, the charitable arm of NHS Human Services.

“Our primary goal is to increase the quality of life for individuals in behavioral health services, and the funding received to conduct this important research is a significant step in the right direction,” said Joe Martz, chief executive officer of NHS Human Services.

Study participants will be selected from a pool of adults with mental illnesses served by NHS in Allegheny, Beaver, Dauphin and Lehigh counties, and who currently are prescribed or will be prescribed at least one psychotropic medication during the study period. Participation in the study will be voluntary and oversight will be provided by Robin Grubs, Ph.D., director of Pitt’s genetic counseling program, one of the country’s oldest and most rigorous counseling programs, and also by nationally recognized ethicist Lisa Parker, Ph.D., of Pitt’s Center for Bioethics & Health Law, who also provides oversight for the National Human Genome Research Institute.

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