Mayo Clinic in Arizona explores link between heart defect and migraines

Tuesday, March 27, 2007

SCOTTSDALE, Ariz. - Mayo Clinic in Arizona is participating in a clinical trial to explore the connection between a common heart defect and migraine headaches. The ESCAPE migraine trial is a controlled, randomized, double-blind study that will be conducted at 45 leading headache clinics and 15 leading interventional cardiology clinics throughout the U.S.

The heart defect involves the patent foramen ovale (PFO), a flap-like opening between the two upper chambers of the heart. In the womb, all babies have this opening that makes circulation more efficient during development. However, following birth, the flaps normally close to form a solid wall between the chambers. If the PFO does not close, the opening can permit venous blood, which is normally filtered by the lungs, to pass unfiltered into the left side of the heart and pumped out to the body; including the brain. It is estimated that 25 percent of adults may have a PFO, but more than 50 percent of patients with migraine with aura may have a PFO, and more than one-third of migraine sufferers may have a large PFO.

"The goal of this trial is to determine if closing a PFO will significantly reduce migraine attacks, which routinely debilitate people and prevent them from working, socializing and enjoying a reasonable quality of life," said Bart Demaerschalk, M.D., a Mayo Clinic neurologist and the principal investigator for Mayo Clinic in Arizona.

The association between PFOs and migraine headaches was first observed by physicians who treated PFOs to remedy other medical conditions, such as stroke. Physicians later noticed a reduced frequency in patients' migraine headaches. Additional informal studies suggest reduced migraine attacks after PFO closure. It is not clear why patients with migraine would be more likely to have a PFO, or why closing the PFO might decrease migraine attacks. Experts speculate that blood that crosses the PFO without being filtered by the lungs contains substances that trigger migraines.

"There is mounting evidence that patients with migraine are more likely to have a PFO, and if it is repaired, migraine attacks may be reduced," says Demaerschalk. "If this trial confirms that closure of the PFO reduces migraine headaches, it could possibly lead to treatments that could have a major impact on the quality of life of millions of people."

More than 28 million Americans suffer from migraine, a neurological disorder associated with headaches that are often severe and disabling. In some cases, these painful headaches are preceded or accompanied by a visual warning sign such as flashes of light, blind spots or tingling in the face and hand. Other symptoms can include nausea, vomiting and sensitivity to light and sound. Migraine pain can be excruciating and may incapacitate sufferers for hours or even days. Women are three times more likely than men to experience migraines.

The first patient, a 53-year-old woman from Virginia, is one of approximately 500 patients who are expected to participate in the nationwide study. Approximately 12 patients at Mayo Clinic will participate in the study.

During the implant procedure, physicians deliver a medical device through the PFO and then open the device's two sides independently, allowing physicians precise placement to close the PFO. The device is implanted through a catheter that is inserted into the femoral vein groin, making this procedure less invasive than open-heart surgeries.

"Our team at Mayo Clinic is very excited to be involved in this important research," said David W. Dodick, M.D., a Mayo Clinic neurologist and the national neurology principal investigator for the study.

Patients may contact the ESCAPE Migraine trial clinical coordinator, Julie Sekella, RN, at Mayo Clinic in Arizona, at 480-342-0814, for additional information.

Mayo Clinic is the first and largest integrated, not-for-profit group practice in the world. As a leading academic medical center in the Southwest, Mayo Clinic focuses on providing specialty and surgical care in more than 65 disciplines at its outpatient facility in north Scottsdale and at Mayo Clinic Hospital. The 208-licensed bed hospital is located at 56th Street and Mayo Boulevard (north of Bell Road) in northeast Phoenix, and provides inpatient care to support the medical and surgical specialties of the clinic, which is located at 134th Street and Shea Boulevard in Scottsdale.

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