You have been diagnosed as having  patent foramen ovale. The foramen ovale is an opening in the atrial septum that allows blood to flow between the atria in the fetus prior to birth. Normally the foramen ovale closes at or shortly after birth. If the foramen ovale does not close it is referred to as a patent foramen ovale (PFO). A PFO may allow blood or emboli to cross from the right atrium to the left atrium. This is called a right to left shunt.

 

If an emboli crosses from the right atrium to the left atrium, it is called a paradoxical embolism. Paradoxical embolism can result in a stroke if the emboli block an artery to the brain. Stroke due to paradoxical emboli can recur in patients who are taking appropriate doses of anticoagulation medications (blood thinners).

 

The Amplatzer PFO Occluder is a percutaneous, transcatheter, occlusion device intended for the non-surgical closure of PFO in those patients who have had recurrent cryptogenic strokes despite being on medication to prevent strokes. The effectiveness of this device has not been demonstrated for this indication.

 

The Amplatzer PFO Occluder is a wire mesh made out of nickel and titanium. The wire mesh is filled by polyester fabric to help close the defect. The polyester fabric is securely sewn into the device with a polyester thread.

 

The benefit of having a device is avoiding surgery to close your PFO (no chest scar and shorter hospital stay and recovery time). You may not need to be on lifelong drug therapy to prevent strokes.

 

Your procedure will be performed in the heart catheterization laboratory. You will lie on an x-ray table, and an x-ray camera will move over your chest during the procedure. The staff will monitor your heart by attaching several small sticky patches to your chest.

 

Your doctor will give you an anesthetic. It may be general or local. This will depend on the technique the doctor uses to place the device. There should not be any significant discomfort.

 

Your doctor may place an imaging probe in your mouth and move it down into your esophagus. This imaging probe makes it possible for the doctor to see your heart up close with an echocardiography machine. Your doctor will insert a catheter through a vein and then navigate it through some of your body's largest veins until it reaches your heart. The doctor will perform an angiogram to visualize your heart and the PFO.    Your doctor will then measure the pressure and oxygen content in different chambers of your heart. The appropriate sized device is screwed onto a cable, put into a special catheter and advanced through your PFO. Your doctor will then push the device out of the catheter until the discs of the device sit on each side of the PFO. Your doctor will carefully study the position of the device in your heart. When your doctor is satisfied with the device position, the device is released by unscrewing the cable that was used to slide it though the catheter. The Amplatzer PFO Occluder is then implanted your heart.

 

The catheter and imaging probe are removed and the procedure is completed. The procedure generally takes 1 – 2 hours. After recovery from anesthesia and bed rest, you should be able to sit up and walk about. Before you leave the hospital, a chest x-ray and/or echocardiogram will be performed to make sure the device is still positioned properly.

 

Because the procedure is less invasive than open heart surgery, your recovery should be easier. You may have an adhesive bandage where the catheter was inserted. You may also have a sore throat if an imaging probe was used. 

 

Many patients have the procedure done in the morning and go home at the end of the day or the following morning. Before you leave the hospital, your doctor will give you guidelines for activities and medications. Your doctor should tell you when you can resume normal daily activities. Medications will be an important part of your treatment. Your doctor will prescribe drugs that you should prescribe at home. The drugs should prevent blood clots from forming. Notify your doctor if your medications cause unpleasant reactions, but do not stop taking them unless instructed to do so. Your doctor may be able to prescribe new medications that better suit you.

 

You will be required to take medication every day for the next 6 months to help prevent blood clots and will be required to take antibiotics for certain medical procedures to minimize the risk of infection of the device. The decision to continue taking medication beyond 6 months is at the discretion of your doctor.

 

You will have to return to your doctor for periodic follow-up visits over the next year. It is important to keep all follow-up appointments that are scheduled for you.