No. The PFO closure device is FDA approved for specific indications. The specific indication for which it is approved is to treat recurrent strokes in patients with PFO who have failed conventional medical treatment. The type of FDA approval (HDE) requires that the device be implanted in centers where an an institutional review board has the authority to monitor the way in which the device is being used.
What are the indications for transcatheter PFO closure?
At the present time transcatheter PFO closure is indicated for closure of patent foramen ovale in patients with recurrent stroke who have failed conventional drug therapy. Patients with other stroke indications may be considered on a case-by-case basis, but special permission must first be obtained.
At the present time, migraine is not an indication for PFO closure. We anticipate participating in an upcoming multicenter, randomized trial to evaluate the effectiveness of PFO closure in patients with migraine. If you have migraines and would like to be non-invasively screened for a PFO please contact us. Even if you are not interested in participating in a trial, it may be of help to your hedache doctor to know that you have a PFO becasue certain medicines may be of special benefit in preventing migraines in patients with PFO.
I have migraines. Should I be screened for a PFO?
Preliminary evidence has shown that PFO closure can substantially reduce migraine frequency. This potential treatment however needs to proven to work.
We anticipate participating in an upcoming randomized, multicenter trial evaluating the effectiveness of PFO closure in patients with migraine and aura.
Patients with migraine who would like to be screened non-invasively for a PFO using Transcranial Doppler (TCD) should contact us. Patients who are found to have a PFO could be considered for participation in this upcoming trial. Even if you do not want to participate in a trial, certain medicines may be better at preventing migraines in patients with a PFO.
When can patients return to their usual activities following PFO closure?
Patients may return to their usual activities the following day. We recommend that patients avoid heavy lifting or straining for two weeks. No amount of physical activity risks dislodging the device.
What are the risks of transcatheter PFO closure?
Risks include bleeding, infection, damage to the heart, heart rhythm problems, device embolization (moving to the wrong place) and stroke. These risks are all very small. For the indication of stroke, the risks are much less than than the risk of recurrent stroke, and also less than the risk of bleeding complications on blood thinners.
Can patients with a PFO occluder have an MRI?
Yes. The PFO Occluder is made from non-ferromagnetic metal (nitinol) and is MRI compatible.
I have another type of heart problem. Can Dr. Love help me?
Dr. Love specializes in congenital heart problems. Congenital heart problems are those are present in the heart from birth, though they may not be diagnosed until adulthood. A PFO is one of the most straightforward types of these problems. Dr. Love also cares for children and adults with other types of congenital heart defects such as:
Atrial Septal Defect (ASD)
Ventricular Septal Defect (VSD)
Patent Ductus Arteriosus (PDA)
Tetralogy of Fallot (TOF)
Transposition of the Great Arteries (TGA)
Other complex cardiac malformations such as single ventricle
