Closing a Common Hole in the Heart May Stop Migraines; Randomized Study to Determine if Closing a PF

Closing a Common Hole in the Heart May Stop Migraines; Randomized Study to Determine if Closing a PFO is an Effective Migraine Treatment

SEATTLE, Dec. 20, 2007 – A procedure to fix a congenital heart defect related to stroke may also be responsible for the disappearance of some people's migraine headaches. Now, a randomized clinical research trial led by neurologists and interventional cardiologists may determine if repairing this common heart defect is an effective migraine treatment.

Mark Reisman, M.D., medical director of research for the Swedish Heart & Vascular Institute, is directing the cardiology aspects of the MIST II trial as the study's national principal investigator. Locally, neurologist William Likosky, M.D., with the Swedish Neuroscience Institute, is overseeing the neurology aspects of Swedish's participation in the trial.

The defect, a hole in the wall separating the two upper chambers of the heart known as patent foramen ovale, or PFO, is found in up to one in five people. Everyone is born with a PFO, which normally closes after birth. But in some people the closure process is incomplete, allowing the ‘used' blood returning from the body to bypass the filtering system of the lungs. It is typically discovered after a stroke and can be closed with an umbrella-like device in a minimally invasive, catheter-based procedure to reduce the risk of future strokes.

Recent studies investigating patients with PFOs have shown strong evidence that there may be a link between PFO and migraine, and that in some patients – particularly those suffering from migraine with aura – closure of their PFO leads to cessation or a significant improvement in the frequency and severity of migraines.

However, until now all the studies have had limitations in that they investigated stroke patients or divers, and they were retrospective (i.e., they asked patients for information about migraines that occurred in the past). Therefore, PFO closure is not currently a proven treatment for migraine alone.

The MIST II Clinical Trial has been specifically designed to investigate migraine sufferers with a PFO and demonstrate if PFO closure can offer an effective treatment for this type of migraine sufferer.

"For so many, migraines are a crippling neurological ailment," said Dr. Likosky. "By conducting further research, we hope to find more answers that can provide relief to a large percentage of those patients."

"Based on our experience, it's possible that more than two thirds of patients who suffer from migraines and have this common heart defect may find relief in this catheter procedure, which takes about 30 minutes to complete" said Dr. Reisman. "To date, PFO closure has only been approved for stroke patients. We hope to show that performing this procedure proactively is an appropriate and effective therapy for migraine sufferers."

According to the National Migraine Association, migraines affect approximately 30 million Americans, with up to 38 million Americans having a genetic propensity to becoming migraine sufferers.

The MIST II Clinical Trial is randomized, meaning that half of the people enrolled in the trial will have their PFO closed (‘closure group') with the BioSTAR® Septal Repair Implant and the other half will not (‘control group'). Both groups will be randomized in the cardiac catheterization lab. They will be treated identically with one exception. The control group will not receive the implant.

For more information about the MIST II Clinical Trial, including enrollment criteria, visit www.pfo-migraine.com or call 206-320-2587.

About Swedish
Swedish is the largest, most comprehensive nonprofit health provider in the Greater Seattle area. It is comprised of three hospital campuses – First Hill, Cherry Hill and Ballard – a freestanding emergency department and specialty center in Issaquah, Home Care Services, and the Swedish Physician Division – a network of about 40 primary-care and specialty clinics. In addition to general medical and surgical care, Swedish is known as a regional referral center, providing specialized treatment in areas such as cardiovascular care, cancer care, neuroscience, orthopedics, high-risk obstetrics, pediatrics, organ transplantation and clinical research. For more information, visit www.swedish.org

About the Swedish Heart & Vascular Institute
The Swedish Heart & Vascular Institute is a regional network of physicians at hospitals and clinics across the Puget-Sound region. It offers a broad spectrum of cardiovascular-care services – from surgical and interventional procedures to the latest advances in heart-disease prevention, diagnosis and cardiovascular health and wellness. The Institute includes almost 20 member clinics and four medical-center affiliates, including Swedish's Cherry Hill and First Hill Campuses in Seattle; Stevens Hospital in Edmonds; Highline Community Hospital in Burien, and Valley Medical Center in Renton.

About the Swedish Neuroscience Institute
In 2004, Swedish expanded its neuroscience services by establishing the Swedish Neuroscience Institute. The team of leading neurosurgeons and other specialists are building a world-class institute dedicated solely to the treatment and advancement of neurological disorders for patients in the Pacific Northwest and around the world. Swedish/Cherry Hill has been designated as the hub for the Institute and has been upgraded with four state-of-the-art operating rooms featuring intra-operative MRI, CT scanning and neuro-interventional radiology capabilities; a renovated neuro intensive-care unit; and a CyberKnife® facility for radiosurgical treatment of tumors throughout the body. SNI specializes in the research for and treatment of stroke; cerebral aneurysms and arteriovenous malformations; movement disorders such as Parkinson's disease and tremors; brain tumors (including both malignant tumors and benign tumors such as meningiomas); neuro-endocrine disorders including pituitary tumors; epilepsy; child neurological disorders; neuro-ophthalmology; headaches; multiple sclerosis and many other neurological conditions and diseases. In each category, physicians from different specialties are brought together to provide a multi-disciplinary approach centered on providing top-notch patient care.

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Media Coverage

To read the transcript from or to view a related story that WXOW Television in La Crosse, WI (channel 19; ABC) recently aired, click here.

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