CLOSING A COMMON HOLE IN THE HEART MAY
First U.S. Randomized Study To Determine if Closing PFO
NEW YORK, NY, January 11, 2006 - A procedure to fix a congenital heart defect related to stroke may be responsible for a welcome side effect for some patients – their migraine headaches have disappeared. Now, for the first time, a randomized clinical research trial led by neurologists and interventional cardiologists may determine if repairing this extremely common heart defect is an effective migraine treatment.
Dr. Robert Sommer, of Columbia University Medical Center (CUMC), will direct the cardiology aspects of the “ESCAPE” (Effect of Septal Closure of Atrial PFO on Events of Migraine) study, which will be led nationwide by Dr. David Dodick, a headache neurologist from The Mayo Clinic in Scottsdale, Arizona.
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 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, in order to reduce the risk of future strokes.
The association of migraines and stroke had previously led doctors to believe that strokes were being caused by the migraines, but it’s now believed that both the strokes and migraines may be caused by the PFO heart defect. In previous observations of stroke patients with a PFO, migraines have disappeared in more than 60 percent of patients following PFO closure procedures. The ESCAPE trial will be the first U.S. study of PFO closures in non-stroke patients and will directly address whether or not the procedure should be considered a possible alternative treatment for patients with migraine headaches that do not respond to medical therapy.
“For so many, migraines are a crippling neurological ailment,” said Mark Green, M.D., director of the Columbia University Headache Center at NewYork-Presbyterian Hospital/Columbia, clinical professor of neurology at Columbia University College of Physicians and Surgeons and a co-investigator for the study. “By examining the root causes of these headaches, we hope to find answers that can provide relief to a large percentage of those patients.”
“Based on our experience, it is 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 Robert Sommer, M.D., director of Invasive Adult Congenital Heart Services at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia and the Cardiovascular Research Foundation, and an Associate Professor of Medicine and Pediatrics at Columbia’s College of Physicians and Surgeons. “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 migraine genetic propensity.
The study of more than 400 patients will enroll patients from 60 neurological centers and 10 cardiac centers nationally. Closure procedures will be performed with the Premere Device, by St. Jude Medical. Patients can obtain additional information about the trial by calling 212-342-5555.
Patients who are 18 to 55 years old and suffer from migraine headaches will be screened for PFOs. Those that are eligible must spend one month without preventive drugs and keep a log of their headaches prior to and after the procedure.
More information about the facilities is available at:
Columbia University Medical Center at http://www.cumc.columbia.edu