St. Joseph Mercy Hospital in Ann Arbor is participating in a national study to determine whether there is a connection between migraine headaches and a tiny hole in the heart called a patent foramen ovale or PFO.

As part of the trial, Dr. Michael O’Donnell, a cardiologist at the hospital, recently closed the PFO of a patient who suffers from migraines. The clinical trial will help doctors determine if closing the PFO is safe and effective in reducing the frequency of migraines -- and whether or not it should become a treatment option.

The patient was the first person in Ann Arbor to receive the procedure as part of the ESCAPE (Effect of Septal Closure of Atrial PFO on Events of Migraine with Premere) Migraine clinical trial.

An estimated 30 million Americans -- about 10 percent of the population -- suffer from migraine headaches, a neurological disorder characterized by chronic and disabling headaches. An estimated 25 percent of young American women are affected by migraines.

Currently, there is no cure for migraines. The headaches may be prevented and treated through drug therapy, but some migraine sufferers do not respond to medications, experience unpleasant side effects or are advised by their doctors against taking them due to another health condition.

“Options for migraine patients may be limited by the failure of prescribed medications to work effectively in all patients as well as the limitations in which prescribed medications may be potentially harmful to some patients with other medical issues,” said O’Donnell, primary investigator of this study, highlighting the importance of another option for migraine sufferers.

The trial expects to enroll 492 patients in the United States who have not found relief from their migraines with preventive medications, have experienced unwanted side effects from drug therapy or have been advised by a doctor against taking the medications due to another condition.

The association between PFOs and migraine headaches was first observed by physicians who treated patients with PFOs for other medical conditions, such as stroke – and later noticed a reduced frequency in patients’ migraine headaches. Subsequent informal studies have suggested reduced migraine attacks after PFO closure. It is not clear why patients with migraine headaches would be more likely to have a PFO, or why closing the PFO might decrease migraine attacks. Some physicians theorize that blood crossing the PFO without being filtered by the lungs contains substances that trigger migraines.

The patient at SJMH was implanted with the Premere PFO Closure System, designed by St. Jude Medical Inc., for PFO closures. During the implant procedure, physicians deliver the device through the PFO and then open its two sides independently for precise placement to close the PFO. By using a transcatheter approach that delivers the device to the heart through a vein in the leg, the procedure is less invasive than open-heart surgery.

“If the closure of the connection between the two upper heart chambers eliminates or significantly reduces the episodes of migraine headaches, we would improve the quality of life to all those patients who had no other means of obtaining that relief by more traditional use medications,” O’Donnell said.

Sponsored by St. Jude Medical Inc., the ESCAPE Migraine trial received approval from the U.S. Food and Drug Administration for an Investigational Device Exemption in December 2005. The controlled, randomized, blinded clinical trial will be conducted at 80 leading headache and interventional cardiology clinics throughout the United States. The Premere System is only available for investigational use in the United States.

For more information about PFO and the ESCAPE Migraine trial, visit www.escapemigraines.com.